Pfizer

Nervous system symptom reports

Female, 40 - 59 years

Age Reported Symptoms Notes
40 2020-12-31 pain in extremity No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, ache... Read more
No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, aches, neck lymph node soreness/slight swelling, fatigue
40 2020-12-31 tremor, tingling CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITC... Read more
CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.
40 2021-01-01 feeling hot Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved... Read more
Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved on their own. employee is 14 weeks pregnant.
40 2021-01-01 pain in extremity Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Sev... Read more
Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Severe headache starting again on day 4 lasting through day 5. Unable to focus, eat because of headache. Sore arm for 24 hrs post vaccine.
40 2021-01-03 numbness, pain in extremity Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. ... Read more
Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. Whole top of foot and toe was really swollen and a lot bigger than the other couldnt walk or put pressure on my foot. Have been home unable to work since december 30th
40 2021-01-03 numbness, sensory loss On Dec 29th, I developed bilateral loss of sensation in my thumb and first 3 fingers, with loss of d... Read more
On Dec 29th, I developed bilateral loss of sensation in my thumb and first 3 fingers, with loss of dexterity. It improved somewhat over the next 45 minutes, but I continue to have loss of sensation in all 10 fingertips, worse in both thumb and 5th digits.
40 2021-01-03 pain in extremity Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted... Read more
Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted Pfizer and IM/ID physician. Will re vaccinate in 5 days. Arm very painful, lump under acromion process. Feels like bursitis.
40 2021-01-03 tingling, numbness Reports paresthesias and subjective sense of "numbess" of R lateral neck, face, R ear and temporal a... Read more
Reports paresthesias and subjective sense of "numbess" of R lateral neck, face, R ear and temporal area of scalp within 30 min of vaccine that persisted x 90 min. Also reported transient "numbness" of R anterior thigh that resolved spontaneously after 30 min. No pruritic, urticaria, rash. No mucus membrane symptoms - no conjunctivitis, rhinitis or oral/perioral symptoms. No mucosal swelling or sense of swelling. No respiratory symptoms. No presyncopal symptoms. Vitals: BP 134/87, Pulse 103, sats 100%.
40 2021-01-03 seizure, tremor, weakness I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shak... Read more
I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.
40 2021-01-03 unresponsive to stimuli, sensory loss, muscle spasms Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as thoug... Read more
Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.
40 2021-01-04 feeling hot, flushing About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense... Read more
About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense of fullness/swelling in my throat. I pulled over and called my husband. I could breathe fine, but the sensation of swelling in my throat was frightening and I felt like I couldnt swallow my saliva. I also had the feeling like I might faint (hot and flushed). This all passed pretty quickly (5 minutes), and I took a benadryl when I got home and rested.
40 2021-01-04 numbness, tingling numbness and tingling in all four extremities; numbness and tingling in all four extremities; interm... Read more
numbness and tingling in all four extremities; numbness and tingling in all four extremities; intermittent weakness in my hands, arms and legs; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0140), via an unspecified route of administration on the left arm on 18Dec2020 12:30 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history reported as none and the patient had no known allergies. The patient's concomitant medications were not reported. It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 19Dec2020 13:30, the patient was experiencing numbness and tingling in all four extremities after the first dose of the vaccine. The patient also experienced intermittent weakness in hands, arms and legs. It was also mentioned that the patient had numbness and tingling in all four extremities for the past 10 days. The patient did not receive any treatment for the events. Outcome of the events were unknown.
40 2021-01-04 numbness She describes joint pain and gradual numbness on her arms.
40 2021-01-04 numbness Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then ... Read more
Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg. Elevated blood pressure, 182/112. Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.
40 2021-01-04 migraine, weakness One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in s... Read more
One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in size)-same side as injection. It was painful and partially mobile. No other symptoms other than those of headache a few days prior mentioned below. I went to urgent care on 12/29 where CXR and soft tissue ultrasound were ordered. CXR normal. US 12/30 showed cluster of lymph nodes in that area. Lump appears to be smaller this week and not painful. Also, I developed a severe migraine on 12/26 (5d post vaccine). So severe that it was debilitating which is unusual for me. It lasted approximately 36 hours.
40 2021-01-04 tingling, numbness Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left h... Read more
Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231) on 23Dec2020 07:15 PM via unknown route of administration (vaccine location: Left arm), at single dose (first dose) for COVID-19 immunization. Medical history was reported none. Concomitant medications included ibuprofen. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not use other vaccine in four weeks. Patient experienced Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in her left hand/fingers and the left side on her lip on 25Dec2020. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
40 2021-01-04 tingling, sensory loss, numbness About 10 mins after I noticed some tingling and numbness on the right side of my head (ear and cheek... Read more
About 10 mins after I noticed some tingling and numbness on the right side of my head (ear and cheek were numb). I also had some numbness on the top of my thigh. I sat for monitoring for a couple hours and was sent home. The tingling moved to the back of my head for a little while last night and seemed to had resolved before I went to bed around 10p. The tingling seems very minimal this morning...on a scale of 1-10, 10 being the most noticeable, yesterday was a 10. Today seems to be a 1 or 2. Only noticeable if I am sitting still and be more along my ear and not my head or shoulder. There is still the weird feeling (similar to numbness) in my face and my thigh. My face is getting better.
40 2021-01-05 weakness Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), ... Read more
Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.
40 2021-01-05 depressed level of consciousness anaphylaxis; ALOC/decreased level of consciousness; This is a spontaneous report from a contactable ... Read more
anaphylaxis; ALOC/decreased level of consciousness; This is a spontaneous report from a contactable Pharmacist (patient). a 40-year-old female patient (no pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140) via intramuscular at Left arm on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history included known allergies to egg, seafood, azithromycin, orange and seasonal allergies. The concomitant was reported as cetirizine hydrochloride (ALLERTEC) and PRN 1371. The patient with no known past medical history brought in by CODE Team to RUH ED with concern for ALOC after getting the COVID vaccination 30-40 minutes PTA. Patient was a nurse and experienced decreased level of consciousness following her COVID vaccination. Patient reports h/o anaphylaxis. She was given epinephrine PTA. Denies SOB, oral swelling, CP. Blood glucose (BGL) within normal limits. Patient denies any other complaints or symptoms at this time. Adverse event start date: 23Dec2020. Treatment was unknown for decreased level of consciousness. The outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis /decreased level of consciousness cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-05 difficulty speaking Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. R... Read more
Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.
40 2021-01-05 feeling cold Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times t... Read more
Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.
40 2021-01-05 feeling hot, pain in extremity left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable ... Read more
left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the left arm, on 19Dec2020 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she took the vaccine on 19Dec2020. On an unspecified date, patient stated that she had no side effects only her arm was hurting. She stated that her whole body is hot. Stated that she has no temperature and is a little nauseous. Stated that whererever she lays down at one can feel the heat. She stated that it was Pfizer BioNTech Covid 19 vaccine EUA is concerned. She stated that she went to the ER and they thought it was because she was taking a medication for urinary tract infection (UTI) and that she was having a reaction. She stated that her doctor told her that the second day she would have had side effects to UTI medicine. She stated that the doctor is stating that it is due to the vaccine. She wanted to know if she should go back to the ER. She stated that her doctor told her to call the place where the vaccine was received for them to monitor her. She stated that she went through her job off site and that this was her first shot. She clarified that she received the shot in her left arm and it was hurting. Outcome of the events was unknown. Information on lot/batch number has been requested.
40 2021-01-05 feeling hot Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I ea... Read more
Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I eat shrimp.
40 2021-01-05 flushing Approximately 5 minutes after vaccine administration, patient began to feel flushed and she was tach... Read more
Approximately 5 minutes after vaccine administration, patient began to feel flushed and she was tachycardia. Brought patient away from public area, gave cool pack, oxygen and called EMS. EMS monitored patient and issue resolved within 20 minutes.
40 2021-01-05 flushing dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; diz... Read more
dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: ej1685) for the first dose via an unspecified route of administration in the right arm on 29Dec2020 09:00 for covid-19 immunization. Medical history included diabetes, anxiety/depression, obesity and allergies to penicillin (PCN). Concomitant medications included metformin hydrochloride (MEFORMIN), glipizide, insulin glargine (TOUJEO), dulaglutide (TRULICITY), gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3, event onset date reported as 29Dec2020 09:15. The events were reported as non-serious. No treatment was received for the event. The outcome of the events was not recovered.
40 2021-01-05 pain in extremity a red area at the injection site /growing red spot at injection site; raised area at the injection s... Read more
a red area at the injection site /growing red spot at injection site; raised area at the injection site/It was raised; irritated area at the injection site/really irritated; sore arm/arm it would wake her up with pain; itching /painful itchy growing red spot at injection site; normal pain at the injection site; there was an induration there; This is a spontaneous report from a contactable physician reporting for herself. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Caller was a ER Physician who received her COVID 19 vaccine last Monday 21Dec2020, and was reporting adverse event at injection site. She reported a red, raised, irritated area at the injection site, stated "thought I got bit by something" and didn't link it to the vaccination, originally. She took Benadryl, treated it like cellulitis by using a heating pad, and applied cortisone. She stated it was persistently getting worse, even seemed worse last night. She had been taking pictures of the skin reaction and wanted to know if there was a way to submit those for follow-up/monitoring. It was also reported painful itchy growing red spot at injection site was reported as worsened. Caller had the vaccine 10 days ago, which was last Monday. She didn't notice at first. She had the normal pain at the injection site. She woke up 3-4 days later, and she felt like she got bit by something. It was a little red. It was painful, itchy, and really irritated. She paid attention to it 3 days ago. She thought this wasn't right. When sleeping on that arm it would wake her up with pain. So she would switch sides. She started taking pics of it yesterday. The redness is getting bigger. She was an Emergency Medicine Physician. She didn't have a prescribing doctor. She got it at (Institution name). She noticed it was there when she first got the shot. It felt like a normal flu shot, and she was fine. She worked out the next day. She had a sore arm like usual with any type of a shot a Tetanus shot or something. She didn't notice anything out of the ordinary until later on, and there was an induration there. It was raised, red, and kind of warm. It was painful and itchy at the same time. It was almost like if a tag in the back of clothes were rubbing it, and she couldn't move all day. There would be an irritated area there. It is getting bigger. Now it was starting to go around her arm. It was not terrible debilitating. She was not allergic to anything. She has put cortisone cream on it, but it didn't change anything. Then, last night, she tried cortisone cream and Neosporin a little later. She then put a medium hot heating pad on it for a nice chunk of the night. It was growing near her lymph nodes now. She said the vial size looked to be about 10 mL. It was a small vial. The nurse did say she could get one more dose out of that vial. She did take Benadryl to sleep at night. So she didn't feel like it was an allergic reaction. Benadryl-Unysom expiration- May2022 Lot: 20E330 Cortisone: Lot: 11885 The Cortisone's lot number was imprinted, and hard to see. The outcome of the events were not resolved.
40 2021-01-05 pain in extremity Arm soreness, mild fatigue but she is overall okay
40 2021-01-05 pain in extremity Second dose of vaccine. Unable to sleep post vaccine evening zero. Severe fatigue post vaccine day o... Read more
Second dose of vaccine. Unable to sleep post vaccine evening zero. Severe fatigue post vaccine day one. Headache. Arm pain out of proportion to previous IM vaccinations.
40 2021-01-05 pain in extremity Symptoms - ? approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the ... Read more
Symptoms - ? approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the vaccine was placed ?too high.? Patient reports she spoke with RN?s on her unit and showed location of vaccination and was educated it was placed too high. Patient reports sore arm after 1st dose but reports, ?this feels so much worse. I can barely lift my arm.? Recommendation? Patient educated to rotate Tylenol and motrin according to the medical directive for prescription medication and to apply ice to injection site. Patient educated to call vaccine support line for worsening symptoms, patient verbalized back understanding and denied further questions at this time.
40 2021-01-05 pain in extremity approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the vaccine was p... Read more
approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the vaccine was placed ?too high.? Patient reports she spoke with RN?s on her unit and showed location of vaccination and was educated it was placed too high. Patient reports sore arm after 1st dose but reports, ?this feels so much worse. I can barely lift my arm.? Patient educated to rotate Tylenol and motrin according to the medical directive for prescription medication and to apply ice to injection site. Patient educated to call vaccine support line for worsening symptoms, patient verbalized back understanding and denied further questions at this time.
40 2021-01-05 pain in extremity Had arm soreness last night. Woke up with body aches, despite taking tylenol. Have had chills and de... Read more
Had arm soreness last night. Woke up with body aches, despite taking tylenol. Have had chills and developed a fever of 101.
40 2021-01-05 pain in extremity Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and starte... Read more
Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and started about 3am . The site was fine but the deltoid and tricep muscles were very sore.
40 2021-01-05 pain in extremity Whole body fatigue the next day. Arm was very Sore. The site was fine but the deltoid and tricep wa... Read more
Whole body fatigue the next day. Arm was very Sore. The site was fine but the deltoid and tricep was very sore. I have regular yearly flu shots with no issues.
40 2021-01-05 pain in extremity Fevers started 12 hours post vaccine. Severe arm pain. Out of proportion to previous IM vaccines.
40 2021-01-05 tingling, weakness Lightheadedness, dizziness - "felt like the room is spinning," weakness and tingling all extremities
40 2021-01-05 tingling Tingling in fingers Fingers contracting without pain, only tingling
40 2021-01-05 tingling Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing,... Read more
Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.
40 2021-01-05 tingling After vaccine administration, c/o of dizziness, "woozy", after 30 minutes c/o bilateral leg tingling... Read more
After vaccine administration, c/o of dizziness, "woozy", after 30 minutes c/o bilateral leg tingling/weakness, difficulty ambulating.
40 2021-01-05 seizure like phenomena Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling d... Read more
Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling dizzy, light-headed and then had a witnessed syncopal episode with seizure-like activity, vomiting and loss of consciousness. Onset of symptoms were almost immediately following receipt of the vaccine. Patient demonstrated seizure-like activity again while in the ED. Patient received lorazepam 1 mg IV, diphenhydramine 50 mg IV, Lactated Ringers 500 ml IV bolus, NS 1000 ml bolus, potassium bicarbonate 25 mEq. Patient ED visit 0852 until 1404. Patient responded well to treatment and was discharged in stable condition.
40 2021-01-06 weakness HEADACHE FEVER CHILLS NAUSEA VOMITING WEAKNESS BODY ACHE
40 2021-01-06 weakness Headache began 5 minutes after shot. Took 500 mg Tylenol. About 4 hours later began feeling weak and... Read more
Headache began 5 minutes after shot. Took 500 mg Tylenol. About 4 hours later began feeling weak and muscle aches. Took 600mg ibuprofen. At 1am had massive headache body aches chills to the core. Took more Tylenol. At 5:30am fever of 100.4 and flu like symptoms. Called into work.
40 2021-01-06 weakness Headache, chills, body-ache, fever, nausea, vomiting, and weakness.
40 2021-01-06 burning sensation, pain in extremity On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful... Read more
On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful. The following day, Tuesday January 5th I woke up with a sore right arm and a slight headache. The headache increased in intensity throughout the day, developing also body aches and a fever of 100.4. The symptoms seemed to improve slightly after taking Tylenol. The next day, Wednesday January 6th I felt much better, the body aches were almost gone, I had no fever and no headache. When I got home from work I noticed hives all over my arms, anterior and posterior neck - going into the hairline, face, especially around my mouth, chest, abdomen, upper and lower back. The affected areas were itchy and I also felt a slight burning/stinging sensation on my neck. Even though I did not notice any hives on my legs, my right ankle was itchy, as well. I took Claritin 10 mg and I did not notice much difference. When I woke up today, Wednesday January 7th the hives were still present on my arms, chest, abdomen and back and they looked like dissipating. It is currently 6:12 pm on January 7th and my hives are almost gone
40 2021-01-06 burning sensation, tingling, hot flush, pain in extremity After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flash... Read more
After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.
40 2021-01-06 discomfort EE reports facial swelling with pressure and HA at 3:00 pm went to the ER at 6:00 pm
40 2021-01-06 pain in extremity I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really cou... Read more
I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really couldn't get out of bed. As the day progressed I got chills, started running a fever, It went up to 104 and my heart rate went up and down from 120-165 so I went to the ER. They gave me fluids and ran a whole bunch of test, tested me for Covid and Sepsis and everything came back normal and negative for Covid. They monitored my heart rate and once it started getting back to normal, they ended up letting me go home, I was there from 8pm to about 3am. After that I felt tired and felt like when I had Covid back in November. I started feeling better about Sunday, still a little tired but felt more back to normal. My heart rate is still getting back to normal so my Dr is following me on that.
40 2021-01-06 tingling, pain in extremity Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at i... Read more
Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at injection site, and then swelling and tingling in left hand. and head ache. Symptoms didn't subside until day 3. Still have pain in left arm that radiates down to elbow. All other symptoms subsided.
40 2021-01-07 cold sweat, pain in extremity Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold s... Read more
Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold sweats and arm throbbing (like someone punching repeatedly in the arm) and sensitive to tje touch. Arm painful for 3-4 days
40 2021-01-07 feeling hot, discomfort Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal... Read more
Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal exertion and at rest while wearing my hospital mask, which I attributed to the cheap quality of the mask. Breathlessness was relieved after I took it off. I shoveled snow with no problem over the weekend, and was off work. Three days later, on 1/3 around 7 pm, I experience the same feeling while wearing the same type of mask, and it was relieve when I took it off. The following day, 1/4 around 2pm, while wearing a different disposable mask in the grocery store, felt extremely overheated and realized I was having difficulty breathing with minimal exertion. This time the feeling did not pass when I left the store/removed my mask, and residual effects of not being able to easily take a deep breath stayed with me the entire day. The feeling was gone in the morning, but did eventually re-occur the next day (tightness in my lungs not allowing for easy deep breaths) on 1/5 near the end of a shift where I had been wearing yet a different type of disposable mask. The symptoms starting around 4:30 pm and lasted throughout the rest of the evening. At this point I notified employee heath and scheduled a covid test. The next two days, on 1/6 and 1/7, the same type of dyspnea persisted throughout the day; while at rest, not relieved, and with no other symptoms (no cough, fever, etc.) Ibuprofen appears to relieve the discomfort, and I have returned to work, however the symptoms are still present if I am not taking Ibuprofen. Possibly some kind of pleurisy. My lung sounds are clear.
40 2021-01-07 numbness, bell's palsy, tingling Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right ... Read more
Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic
40 2021-01-07 numbness, numbness and pain in extremities neuropathy/ started acutely in feet bilaterally / persist intermittently in left extremities; One-ti... Read more
neuropathy/ started acutely in feet bilaterally / persist intermittently in left extremities; One-time episode of upper extremity (UE) numbness; This is a spontaneous report from a contactable health care professional (patient). A 40-year-old female patient (not pregnant) received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown) at single dose via an unknown route at left arm on 26Dec2020 for Covid-19 immunization. COVID-19 vaccine was administered in Pharmacy or Drug Store. Medical history was reported as "none". Patient had no COVID prior vaccination, further reported as patient was not diagnosed with COVID-19 prior to vaccination. No known medications, food, or other products allergies. Concomitant drugs (Other-medications-in-two weeks) included levocabastine hydrochloride (ZYRTEC), diphenhydramine hydrochloride (BENADRYL) as needed, ibuprofen (MOTRIN), and multivitamin. No other-vaccine-in-four weeks received. Patient experienced adverse-event of neuropathy, which started acutely in feet bilaterally and now (as of 02Jan2021) persist intermittently in left extremities (LEs). One-time episode of upper extremity (UE) numbness. No weakness. Patient inquired if 2nd dose should be held. Adverse-event-start-date was 26Dec2020. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received. The event was reported as non-serious. Since the vaccination, patient had not been tested for COVID-19. Outcome of the event was not resolved. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of peripheral neuropathy and upper extremity (UE) numbness due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and nerve conduction tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-07 numbness acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; acute bilateral nu... Read more
acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: FK1730, via an unspecified route of administration at Left arm from 19Dec2020 09:15 to 19Dec2020 09:15 at SINGLE DOSE for COVID-19 immunization. Medical history reported as none. Concomitant medication included acetylcarnitine (ACETYL L CARNITIN), magnesium, colecalciferol (VITAMIN D), and probiotics. On 29Dec2020 16:30, the patient developed acute bilateral numbness in her thumb and first 3 fingers, with loss of dexterity. It lasted approximately 30-45 minutes, and then improved somewhat but it continues to be present in all digits. The patient was not diagnosed with COVID-19 prior to vaccination and post vaccination. The outcome of the events was not recovered.
40 2021-01-07 pain in extremity, weakness I had arm soreness that I needed to take Tylenol and I was exhausted no energy I had a hard time wa... Read more
I had arm soreness that I needed to take Tylenol and I was exhausted no energy I had a hard time walking around the hospital I almost fell asleep on my desk. I fell asleep that night and felt fine the next day! Advanced maternal age because I'm 40 so I'm high risk, Low on Vitamin D3 early in my pregnancy, beginning of Dec I was lightly anemic, due date Feb 9th
40 2021-01-07 pain in extremity Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started a... Read more
Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started and lasted until 5am Then chills started from 3:00am until 7:00am Then fatigue continued throughout the day- I slept for 15hours
40 2021-01-07 pain in extremity sore arm, headache, chills, fatigue
40 2021-01-07 pain in extremity low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hour... Read more
low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hours (no more than 10) arm pain (at injection site)-it is a bit warm to the touch and a small bruise- still occuring (approximately 12 hours after it started this morning)
40 2021-01-07 pain in extremity Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a conta... Read more
Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at the left arm on 31Dec2020 13:00 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness, diarrhea, sore arm, headache, fatigued, and chills on 01Jan2021. The patient did not received any treatment for the evets. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19 via a blood test in Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient recovered from the events on an unknown date in Jan2021.
40 2021-01-07 tingling Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and righ... Read more
Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.
40 2021-01-07 tingling Dizziness Tingling Left arm to finger tips.
40 2021-01-07 tremor, migraine bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; ... Read more
bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue. She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.
40 2021-01-07 tremor After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Ra... Read more
After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.
40 2021-01-08 hot flush Dizziness, Headache, Myalgia, Nausea Vomiting, hot flash, right side chest heaviness x 1 day
40 2021-01-08 pain in extremity Nausea, headache and arm pain
40 2021-01-08 pain in extremity 1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pa... Read more
1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.
40 2021-01-09 difficulty speaking Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ... Read more
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
40 2021-01-09 hot flush After sitting down in the observation area and I was just starting to register for vsafe my heart st... Read more
After sitting down in the observation area and I was just starting to register for vsafe my heart started to pound then I experienced a hot flushed feeling that went through my entire body and my heart started racing and felt not well. I told the nurses what happened and they said I looked pale. I laid down and started to feel better after a few minutes.
40 2021-01-09 numbness I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I ... Read more
I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl
40 2021-01-09 numbness 11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, sev... Read more
11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain and kidney pain
40 2021-01-09 tenderness Woke up this morning with swollen, and extremely tender right armpit area. It is visually swollen co... Read more
Woke up this morning with swollen, and extremely tender right armpit area. It is visually swollen compared to the left and is very painful. I am under the assumption this is likely a swollen lymph node post second vaccination. I have taken ibuprofen in attempt to help with pain and inflammation but does not seem to be helping much at this time. I anticipate this will improve over time.
40 2021-01-10 cold sweat itchy, clammy, sweaty
40 2021-01-10 discomfort Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . ... Read more
Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . Described discomfort as constant. The next day on 01/10/2021 at about 8am, the discomfort started to radiate down to her left armpit area and left lateral breast area. Denied redness or fever but did state area was " swollen" . Stated affected areas felt " hard but it was probably because there was swelling". Patient states she had full range of motion to left arm, no numbness or tingling to left arm or hand. No complaints of shortness of breath , chest pain, or rash.
40 2021-01-10 difficulty speaking, flushing This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient r... Read more
This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
40 2021-01-10 feeling hot, weakness Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain unde... Read more
Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,
40 2021-01-10 feeling hot 0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started ... Read more
0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal
40 2021-01-10 numbness, tingling, weakness shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours af... Read more
shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours after vaccination and developed loss of range of motion, weakness, inability to lift arm, tingling and numbness down the length of arm. Severe pain prohibiting ADLs; needing assistance with every day functions. Pain is incrementally improving but after 4 days still without recovery. Suspect nurse placed too high, injecting into bursa instead of deltoid muscle. RN seemed concerned after injection. She also was not sitting during injection, increasing the likelihood of injecting too high.
40 2021-01-10 migraine chills, body aches and migraine beginning on 1/4/21 and lasting until 1/6/21.
40 2021-01-10 pain in extremity, muscle spasms On Friday I developed soreness in neck slowly spreading from left to right and still ongoing today w... Read more
On Friday I developed soreness in neck slowly spreading from left to right and still ongoing today which is Monday. Having upper back and neck pain and aching in right arm and spasms in right shoulder. Have used heat, nsaids, Tylenol, and muscle relaxers. May feel slightly improved today but not much. This could be coincidental but figured I should report in case others have experienced or will experience. I do not recall hurting my neck.
40 2021-01-10 pain in extremity Significant arm pain starting one after injection lasting 48 hours. Mild arm pain afterwards for ano... Read more
Significant arm pain starting one after injection lasting 48 hours. Mild arm pain afterwards for another 24 hours. Joint pain, headache and low grade fever for 48 hours.
40 2021-01-10 tingling Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; conf... Read more
Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-11 weakness Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontane... Read more
Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 05Jan2021 07:45AM at a single dose for COVID-19 immunization. The patient's medical history included hypothyroid and ADD (Attention Deficit Hyperactivity Disorder), both from an unknown date and unknown if ongoing. The patient had known allergies to PCN. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Concomitant medications included unspecified/ other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 09:00 AM, the patient experienced fever, chills head ache, severe joint pain, nausea, congestion, and severe weakness. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. Outcome of the events was unknown. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect. Information about lot/batch number is requested.
40 2021-01-11 weakness severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant w... Read more
severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant weakness; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 40-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route on left arm at single dose for COVID-19 immunization on 04Jan2021, 07:45 AM, at 40-year-old. No relevant medical history. No allergies to medications, food, or other products. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 04Jan2021, 08:00 PM, 12 hours after vaccine, the patient developed severe shaking chills, fever, muscle/bone aches, headaches, nausea, and significant weakness (this lasted about 8 hours). No treatment was received. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.
40 2021-01-11 burning sensation Shortness of breath, chills and Burning sensation on face. I took some Benadryl to help
40 2021-01-11 flushing Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in num... Read more
Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in numerous anaphylactic events. The patient had been consulted by her immunologist to proceed with vaccination and due to her history she was observed for a period of 30 minutes. Upon returning for her 2nd vaccination she reported that she experienced some skin manifestations (hives) but no anaphylactic reaction resulting in difficulty breathing. She stated that she had discussed this again with her immunologist and she wished to proceed with the 2nd dose and she was prepared to receive EpiPen if necessary if reaction develops. Within 10 minutes of the vaccination she felt flushing sensation and then itching all over and her "throat closing up". She was quickly administered 0.3 mg IM epinephrine and IM diphenyhydramine with some improvement in her symptoms. While being transported to the ED an additional 0.3 mg dose of epinephrine was administered. The emergency department also administered the following treatments: famotidine 40 IV x 1 dose, methylprednisolone 125 mg IV x 1 dose, racepinephrine nebulized x 1 dose. The patient was ultimately discharged approximately 2 hours later with return to her baseline condition.
40 2021-01-11 flushing Employee immediately felt flushed. States that by 0400 the next day she awoke to fever of 102.1'F, ... Read more
Employee immediately felt flushed. States that by 0400 the next day she awoke to fever of 102.1'F, severe body aches, chills, and lethargy
40 2021-01-11 numbness Had a headache prior to vaccine. 20 minutes after vaccine started feel numbness on left side of face... Read more
Had a headache prior to vaccine. 20 minutes after vaccine started feel numbness on left side of face and it was affecting vision a little. Called them and they told me to come back. I felt light headed and they put me in the wheelchair and took me to ER. ER: assessed by Dr: heart monitor for 30 minutes. Sent me home to watch my symptoms. Numbness in my face lasted into next day but then went away after that. Still having dizziness on and off since I've received the shot. Headaches - having them, too, off and on. TeleMed appt with DR on 7th. She recommended a MRI of brain - normal.
40 2021-01-11 pain in extremity Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evo... Read more
Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evolving cellulitis. Provider prescribed Keflex 500 mg PO Q8hr x 10 days. Had a temperature of 103 on 1/4 but resolved on 1/8.
40 2021-01-11 pain in extremity Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expec... Read more
Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expected fatigue, muscle aches, headache, chills. however, she had also developed significant swelling in her left armpit and the swelling has spread into her left chest wall and down into her left ribs. It has also become painful. It?s very painful to lower her arm against her body, to raise her arm above her shoulder, to lift anything, even a bottle of water. It?s also painful to take a deep breathe right in the area on the left chest where the swelling is and into her ribs under her armpit. The area doesn?t seem to be significant red or warm. It is very tender to touch and the swollen area is firm. It has not responded to ice or NSAIDS. Her shoulder and arm do not seem to have any swelling."
40 2021-01-11 pain in extremity lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021... Read more
lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021 in the morning, worsened over the next 48 hours; swelling progressed to level that made resting arm against body too painful, lifting arm above level of shoulder too painful, lifting objects in left hand too painful, deep breathe caused pain in left chest and rib/flank area, swelling in chest area progressed across chest toward neck and covering clavicle. swelling continued to increase until 1/12/2021, the first day which swelling and pain has decreased.
40 2021-01-11 pain in extremity Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on K... Read more
Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on Keflex 500 mg PO Q8hr x 10 days. Had a temp of 103 on 1/4/21 but resolved by 1/8/21.
40 2021-01-11 pain in extremity Myalgia Neck pain, arm pain, and injection site discomfort Narrative:
40 2021-01-12 discomfort heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that we... Read more
heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that went down from her neck to her abdomen; pain that went down from her neck to her abdomen; injection pain on left arm.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686, expiration date not reported), intramuscular on the left arm on 05Jan2021 at 15:00 to 05Jan2021 15:00 at SINGLE DOSE for Covid-19 vaccine. Medical history included allergies, gallbladder problems, and had a little diarrhea. Concomitant medications included famotidine (PEPCID) for any potential allergic reaction, and diphenhydramine hydrochloride (BENADRYL) for allergies, all are ongoing. On 05Jan2021, the patient experienced left ear pain, left side of tongue is sore, pain that went down from her neck to her abdomen, injection pain on left arm, and on 06Jan2021, heaviness in one/left side of the body. The patient is most concerned with the pain she is experiencing. The patient was calling about Covid vaccine and got her first shot yesterday, on 05Jan2021, around 3pm. The patient stated that they had her stay about 30 minutes to make sure no major side effects. She had gone home and noticed that her tongue on left side was swollen and persisted into the evening and had a little diarrhea. She was experiencing left ear pain and decided to lay down. She stated that when she laid down noticed that she had pain that went down from her neck to abdomen, that when she woke up this morning that she had pressure on left side of her body and everything else had gotten better. She clarified that it was not swollen but sore. She stated that the diarrhea is not related to the Covid vaccine but is because she had gallbladder problems, her gallbladder was taken out before the vaccine. She stated not pressure just heavy and that the arm was regular injection pain. She stated that the shooting pain in ears is continuous like she was getting an ear infection. She stated that the symptoms are all on her left side, she clarified pressure on left side as heaviness. Stated that the allergies were diagnosed way before Covid vaccine. The patient wanted to know if other people have experienced these side effects. She stated that left side of tongue swollen resolved overnight because she did not wake up with it. Later she clarified that her left tongue was sore. Resolved completely. She stated left ear pain started last evening, that it comes and goes. Stated that the pain that went from neck to her abdomen started yesterday evening and stopped yesterday evening. Stated her left arm is sore. Stated it is sore if she touches it and is okay if she is just sitting there. She stated that she took diphenhydramine hydrochloride 25mg in case her tongue was swollen and she was having a reaction. Stated that she took two acetaminophen (TYLENOL) before she went to bed. The outcome of the events of left ear pain and injection pain in left arm was not recovered, while pain that went down from her neck to abdomen recovered on 05Jan2021, heaviness in one side of the body recovered on 06Jan2021, the rest of the events recovered on an unspecified date. The seriousness of left arm injection pain was not provided, reporter assessed other events as non-serious. The causality for the event of injection pain to left arm was related to the suspect drug, causality for other events was unknown.
40 2021-01-12 feeling hot, tenderness I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painf... Read more
I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painful and warm to the touch., slightly itchy but painful when itched. I did not notice the rash anywhere else that day. I feel warm in the face and ears but temperature has stayed between 98.3-98.9 since vaccination was administered. I noticed raised red bumps from my olecranon to mid forearm on the ulnar side of both arms but moreso on the right arm.
40 2021-01-12 flushing Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flus... Read more
Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose
40 2021-01-12 numbness, tingling I began feeling lightheaded and dizzy almost immediately followed by extreme fatigue. There was init... Read more
I began feeling lightheaded and dizzy almost immediately followed by extreme fatigue. There was initially some mild tingling in extremities. After an hour later, my legs were almost numb and I had difficulty moving them. The fatigue got increasingly worse
40 2021-01-12 pain in extremity Painful Left arm with movement Narrative:
40 2021-01-12 pain in extremity Left arm pain, headache, chills. Resolved.
40 2021-01-12 tingling, numbness Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; Tingling and mild numbnes... Read more
Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EK9231, via an unspecified route of administration in the left arm, on 06Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included chronic migraine and allergies to medications, food, or other products including penicillin. Concomitant medication included ethinylestradiol, levonorgestrel (SRONYX) for birth control. The patient previously took piroxicam and experienced allergy. The patient was not pregnant. The patient was not diagnosed with covid-19 prior to vaccination nor was she tested for Covid-19 since vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5 on 07Jan2021, 10:00 AM, with outcome of not recovered. The events were reported as non-serious with no treatment received.
40 2021-01-12 tingling, numbness ?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my va... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my vaccine and when I arrived home about 1pm that day My leg felt odd. when walking, standing I felt an odd sensation in my left foot/lower calf area. I had body aches mild which progressed at night especially pain running down my left side of my body. The next morning I put on my clothes for work and my body still mild aches but the pant leg was tight especially around the calf. My My left foot was swollen as well as my shoe fit tighter. I also had a numbing sensation through the leg. I had an ache behind the calf and the heel of my foot as well as the left foot of my left foot. The swelling remained and I worried I might have a DVT. I called my primary care DR office and they said I should go to the ER. I called employee health at my job and they told me go to the ER. So on 12/29/2020 I went to the ER. The providers there also thought I had a DVT especially after examining my leg and recognizing the significant swelling. My US venous doppler showed negative for DVT however a significantly enlarged lymph node. As of today the swelling is much improved however still slight. The sensation in my left foot is still not the same as before. I have a numbness and tingling sensation that runs from my Left lateral calf down to the sole of my foot.
40 2021-01-13 pain in extremity Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that... Read more
Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that lasted 2 days. A couple days of fatigue. I had on episode of vomiting, I believe it was the 12/31 or 1/1/.
40 2021-01-13 tingling, weakness Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting.... Read more
Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting. Unable to walk due to pain and weakness for 24 hrs
40 2021-01-13 tingling After second dose of Pfizer COVID-19 vaccine, patient reported tingling sensation that started in he... Read more
After second dose of Pfizer COVID-19 vaccine, patient reported tingling sensation that started in her feet and traveled up her legs. Patient refused PO benadryl but took Cetirizine 10 mg PO X 1. Patient was instructed to wait for 30 minutes of observation. At that time, the patient reported that the tingling sensation remained. The patient was offered to be taken to the emergency department, but decided to leave against medical advice.
40 2021-01-13 tingling In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swolle... Read more
In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swollen mouth and tingling in the face. where it took a Benadryl at the time.
40 2021-01-13 cold extremities Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hand... Read more
Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89
40 2021-01-14 feeling hot, feeling cold I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing... Read more
I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing felt slightly off however, I was not aspirated secretions. My throat felt slightly thick and I had the sensation of wanting to clear my throat. I took a deep breath and I could breath. It started to feel like my throat was getting sore or irritated. I felt slightly warmer. I decided to wait the full 30 minutes. When I went to stand had a moment of dizziness that passed but then I felt lightheadedness for about 2 hours after the injection. My ear felt like it was warm and there was slight pressure there. My throat continued to feel irritated and still feels lightly irritated after 4 days. After about 3 hours it felt like something lifted and I felt better. That night I was really fatigued and tired. Maybe slightly cold. The next day felt fine except for the throat irritation that still persists today. The side where I received the injection my arm, shoulder, and chest area felt affected for two days after receiving injection.
40 2021-01-14 migraine within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nause... Read more
within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nausea. within 12 hours i had body aches and chills which resolved. after five days i have still been experiencing migraine headaches
40 2021-01-14 pain in extremity partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I... Read more
partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
40 2021-01-14 tingling, numbness Pfizer-BioNTech COVID-19 Vaccine EUA. Facial numbness and tingling beginning aproximately 40-45 minu... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Facial numbness and tingling beginning aproximately 40-45 minutes after injection. Resolved approximately 2-3 hours later.
40 2021-01-14 tingling 1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/... Read more
1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response
40 2021-01-14 tremor Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report fro... Read more
Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
40 2021-01-15 numbness Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I ... Read more
Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I had a metallic taste in my mouth and the left side of my tongue went numb. A little later the left side of my face felt weird and the inside of my ear felt numb. It wasn't tingling, but it felt like I had a Novacaine shot (like when you get a filling at the dentist). My neck got stiff and I was really tired. The symptoms lasted about 4 hours. When I woke up this morning the left side of my face and jaw still do not feel 100%. My left eye is watery. I'm very tired.
40 2021-01-16 weakness Dizziness, weakness, injection site pain, tiredness, headache, chills, joint pain, nausea.
40 2021-01-16 migraine, pain in extremity Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post in... Read more
Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post injection (12/25/20). Mild to minimal nausea off and on the day after injection. Extreme left arm pain from that injection day through the 4th day post injection (12/27/20). After 2nd dose - bruised arm at injection site. Left arm pain not as severe as 1st injection. Headache more mild.najsea a bit more noticeable off and on. Wheezing and nasally. Muscle aches.
40 2021-01-17 migraine Starting the evening January 14th I experienced a high fever of 102.3 which responded to Tylenol how... Read more
Starting the evening January 14th I experienced a high fever of 102.3 which responded to Tylenol however, was persistent for 48hours; in conjunction I experienced significant body aches, migraines, diarrhea, chills, and fatigue. Fever broke by Sunday morning however continuance of body aches and fatigue lasted through the weekend.
40 2021-01-17 pain in extremity severe aching hands/severe arm pain; feet like arthritis bad day after vaccine; Low grade fever 99.5... Read more
severe aching hands/severe arm pain; feet like arthritis bad day after vaccine; Low grade fever 99.5 c; This is a spontaneous report from a contactable Physician .This Physician reported different events for 2 doses. This case is for 2nd dose. The 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at left arm on 08Jan2021 at SINGLE DOSE for COVID-19 immunization. She received the first dose on 17Dec2020 8:00 AM at right arm at single dose Lot number#Ej1685 and she had flare a week after first vaccine with mild foot swelling but severe leg and foot pain.Medical history included Possible asthma and left foot post traumatic arthritis with multiple surgeries including precious allograph, meralgia parasthetica left side. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. None Concomitant medications (received within 2 weeks of vaccination) .No known allergies. . After second vaccine severe aching hands, feet like arthritis bad day after vaccine. Low grade fever 99.5 c. No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovering on unspecified date. Information on lot/batch number has been requested.
40 2021-01-17 pain in extremity 1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. G... Read more
1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. GOT AN EKG, XRAY, BLOOD TEST. FEVER UNTIL 8PM (101 F); BODY ACHES.
40 2021-01-17 pain in extremity Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint ... Read more
Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint pain, chills, low grade temperature, diaphoresis, lethargy confusion (day 1 only) headache- symptoms last 4 days with height at 24-48 hours
40 2021-01-17 tingling - My fingers are tingling - I can't grab anything or type very well
40 2021-01-18 weakness Back pain, headache, joint pain, weakness, fever,
40 2021-01-18 weakness Back pain, headache, joint pain, weakness, fever, chest pain.
40 2021-01-18 difficulty speaking During the Covid vaccine observation period the patient complained of hoarseness, itching and throat... Read more
During the Covid vaccine observation period the patient complained of hoarseness, itching and throat swelling. The patient had history of chronic urticaria and prior to receiving her vaccine had taken benadryl, ranitidine as well as an OTC antihistamine at home. She was escorted via wheelchair to the ED, BP 151/102 and pulse 101 in ED, pt noted to have blanching hive-like rash on her chest as well. Received Epinephrine 0.3mg, prednisone 60mg PO x 1. Pt was monitored for 3 hours and discharged to home.
40 2021-01-18 hot flush, tingling 3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some ... Read more
3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.
40 2021-01-18 numbness, tingling, pain in extremity STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATI... Read more
STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATION WITH SEVERE PAIN AND ELEVATED TEMPERATURE IN AREA, DIFFICULTY WITH ADDUCTION OF ARM, PAIN RIGHT SHOULDER WITH SWELLEING AND RIGHT TORSO PAIN,
40 2021-01-18 pain in extremity severe leg and foot pain/severe arm pain; difficulty lifting arm; history of mild arthritis foot/Had... Read more
severe leg and foot pain/severe arm pain; difficulty lifting arm; history of mild arthritis foot/Had Flare a week after first vaccine; Had flare a week after first vaccine with mild foot swelling; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ej1685), via an unspecified route of administration on 17Dec2020 at 08:00 AM on Right arm at single dose for COVID-19 immunization in hospital. Medical history included possible asthma, left foot post traumatic arthritis with multiple surgeries including precious allograft, meralgia paresthetica left side otherwise healthy (History of mild arthritis foot and ankle surgery). Known allergies was none. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had history of mild arthritis foot and ankle surgery, she had flare a week after first vaccine with mild foot swelling but severe leg and foot pain in Dec2020, severe arm pain about 2 hours after vaccine with difficulty lifting arm for 24 hours after vaccine on 17Dec2020. Took mefenamic acid (ADVIL) for pain. Elevated feet for swelling. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of event 'severe leg and foot pain/severe arm pain' included mefenamic acid (ADVIL), for event 'foot swelling' included Elevated feet; no treatment was received for the other events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
40 2021-01-18 pain in extremity Sore throat; Headache/has had an off and on headache since this morning; Nausea; Sore arm/had a sore... Read more
Sore throat; Headache/has had an off and on headache since this morning; Nausea; Sore arm/had a sore right arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date: Mar2021), via an unspecified route of administration on the right arm on 04Jan2021 (between 16:00- 16:15) at a single dose for COVID-19 immunization. Medical history included ongoing Hashimoto's disease about 7-8 years ago. She said she doesn't take medication all the time for the condition. Concomitant medication included azithromycin (Z-PAK), bifidobacterium infantis (ALIGN). Patient had nausea since 06Jan2021. Her sore arm started at around 3:00 AM on 05Jan2021 and lasted only one day. The caller asked if the nausea could be caused by the COVID-19 Vaccine, and if so, should she get the second dose of the COVID-19 vaccine. Reported the nausea is more of an annoyance, and she doesn't feel like she is going to throw up. Her nausea has been persisting since it started on 06Jan2021, but had worsened from 07Jan2021, to 08Jan2021. She said she woke up the morning of 08Jan2021 with a sore throat, and has had an off and on headache since the morning. Outcome of the event sore arm was recovered on 05Jan2021, for the remaining events was not recovered No prior vaccinations within 4 weeks. The reporter considered the event non-serious.
40 2021-01-18 tremor after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 da... Read more
after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 days. Eye pain and pressure
40 2021-01-19 numbness, tingling Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21... Read more
Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21), she began to have numbness and tingling in the right arm and right side of face and developed dizziness, headache, nausea, and fatigue. Advised by employee COVID hotline to report to the ED.
40 2021-01-19 numbness 1-2 DAYS AFTER VACCINATION PATIENT EXPERIENCED ARM NUMBNESS. TODAY AT 2ND DOSE SHE NOTIFIED US SHE S... Read more
1-2 DAYS AFTER VACCINATION PATIENT EXPERIENCED ARM NUMBNESS. TODAY AT 2ND DOSE SHE NOTIFIED US SHE STILL IS EXPERIENCING IT BUT HAS SLIGHTLY IMPROVED IN SENSATION
40 2021-01-19 pain in extremity, feeling hot, feeling cold Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in undera... Read more
Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in underarm and body aches. Overnight I was restless and unable to sleep well, body aches and hot and then chilled and cold. By morning my arm was so sore and swollen it was difficult to move it, continued with all over body aches, fatigue to the point of unable to sit up, no fever but alternated chills/cold and hot/sweat. I did take ibuprofen every 4-6 hours throughout the day. This is the same type of reaction I had to tetanus when a teen.
40 2021-01-19 pain in extremity, nerve pain Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit wi... Read more
Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched; Swollen lymph node in left armpit with pain radiating down arm; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 08Jan2021 08:45 at single dose at left arm for COVID-19 immunization. Medical history included osteopenia, vitiligo, known allergies: Demerol and Vicodin. The patient's concomitant medication received in two weeks included Vitamins. The patient previously took the first dose of bnt162b2 intramuscularly on 18Dec2020 20:45 (lot number: EH9899) at single dose at right arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine received in four weeks. The patient experienced swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched on 09Jan2021 07:00. No treatment received for the events. No COVID prior vaccination. COVID test post vaccination: Nasal Swab Negative on 05Jan2021. The outcome of the events was not recovered.
40 2021-01-19 pain in extremity Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both... Read more
Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both arms), Chest pain and squeezing sensation in chest and both arms (lasted 6 days), altered heart rate (lasted 2 days), internal swelling (was told this is what was causing the "squeezing" sensation)
40 2021-01-19 pain in extremity Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, le... Read more
Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-19 tingling, numbness Upper back pain, shoulder and neck pain, numbness in arms, tingling- ongoing for one week
40 2021-01-20 weakness, tingling Throbbing pain; tingling fingers in left arm; pain going up the neck of left side; fever; chills; jo... Read more
Throbbing pain; tingling fingers in left arm; pain going up the neck of left side; fever; chills; joint pain (both shoulders, low back, hips, and knee); loss of appetite; fatigue; weakness; headache; muscle pain; This is a spontaneous report from a contactable Other HCP (patient). This 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 08Jan2021 on Arm left at single dose (Lot # 3249) for covid-19 immunisation. Medical history included Osteoporosis, vitamin D deficient. No known allergies. No other vaccine in four weeks. Concomitant medications included other medications in two weeks. She experienced throbbing pain and tingling fingers in left arm, pain going up the neck of left side. Also experience typical side effects: fever, chills, joint pain (both shoulders, low back, hips, and knee), loss of appetite, fatigue, weakness, headache, and muscle pain on 09Jan2021. No Covid prior vaccination. No covid tested post vaccination. No treatments received. Outcome of the events was recovering.
40 2021-01-20 cold sweat, pain in extremity, pain in extremity, cold sweat, pain in extremity, cold sweat My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't... Read more
My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't feel great then I developed tachycardia, dry heaves and broke into a cold sweat. The event lasted between 1.5-2 hours.
40 2021-01-20 discomfort 40 y/o female who refers dizziness 10 minutes after vaccination covid-19. also sensation of heavines... Read more
40 y/o female who refers dizziness 10 minutes after vaccination covid-19. also sensation of heaviness on back of neck.
40 2021-01-20 difficulty speaking Had a hoarse voice, only could speak at a high pitch. I went the paramedics and waited it out while ... Read more
Had a hoarse voice, only could speak at a high pitch. I went the paramedics and waited it out while they checked my vitals. Voice came back after 15 minutes. At first I could only talk with a deep voice and then it all went back to normal. Benadryl was taken once I got home.
40 2021-01-20 feeling cold, nerve pain Experience skin nerve pain all over my body; Experience skin nerve pain all over my body; Extreme co... Read more
Experience skin nerve pain all over my body; Experience skin nerve pain all over my body; Extreme cold sensation after bowel movements; This is spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided), via an unspecified route of administration on 04Jan2021 10:15 at single dose for covid-19 immunization. Patient is not pregnant. Medical history included severe post concussion syndrome (5 major concussions), anxiety, depression, raynaud's syndrome, pineal gland cyst (last MRI Oct2020 reveal cyst was 12mm). The known allergies included Cipro, sensitive to many food, high allergy to mold, grasses, trees. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fluoxetine hydrochloride (PROZAC), rizatriptan benzoate (MAXALT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , lactulose (LACTUL), ongoing medications included mometasone furoate (FLONASE), budesonide (BUDESONIDE), olopatadine (OLOPATADINE), ipratropium (IPRATROPIUM) , fremanezumab (AJOVY), allergy shots. 48 hours after injection on 06Jan2021 13:00, patient began to experience skin nerve pain all over body accompanied with extreme cold sensation after bowel movements, has been 6 days and getting worse. She will be going to urgent care tomorrow. She was between primary care physicians until 13Jan2021. Patient didn't receive treatment for the adverse events. The outcome of events was not recovered. Information about lot/batch number has been requested.
40 2021-01-20 feeling of body temperature change Fever, (felt like she was freezing then burning up) headache, bodyache.
40 2021-01-20 flushing, burning sensation Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest... Read more
Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest within hours of receiving 2nd dose of vaccine. She stated that she has continued experiencing it intermittently, has taken Benadryl at night time, and is planning on trying Zyrtec.
40 2021-01-20 numbness Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upp... Read more
Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upper and lower extremity numbness causing ER visit; Severe fatigue; slept for two days straight; Sore throat; Headache; Neck and shoulder pain; Neck and shoulder pain, Lower extremity joint pain; Kidney pain; This is a spontaneous report from a contactable other health professional. A 40-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly in the right arm on 29Dec2020 at 10:00 at 40-years-old at a single dose for COVID-19 immunization. : The patient did not get another vaccine in four weeks around the time of the suspect vaccine. The patient's medical history was reported as none. Concomitant medications were not reported. On 07Jan2021 at 05:00, the patient experienced: severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue, slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain, and kidney pain (2 days as reported); and the patient went to the emergency room. The patient underwent lab tests and procedures which included COVID-19 PCR-MHS: unknown (COVID test type post vaccination=Nasal Swab, COVID test name post vaccination=COVID19 PCR-MHS) on 07Jan2021, Rapid Strep with Reflex: negative (COVID test type post vaccination=other, COVID test name post vaccination=Rapid Strep with Reflex) on 07Jan2021. The clinical outcome of the events was recovered on an unspecified date in Jan2021.
40 2021-01-20 pain in extremity Arm mildly sore; headache and vomiting after 12 midnight. Headache was positional . Lasted about 3... Read more
Arm mildly sore; headache and vomiting after 12 midnight. Headache was positional . Lasted about 36 hours. Ibuprofen
40 2021-01-20 pain in extremity temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experien... Read more
temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; She is very achy; shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand; This is a spontaneous report from a contactable nurse (patient). This 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686) intramuscular, in left deltoid, on 11Jan2021 at 10 AM, COVID-19 immunization. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing asthma diagnosed at childhood, ongoing diabetes diagnosed in her twenties, she was overweight, about 7 or 8 years ago she ended up having cellulitis due to the nurse not using aseptic technique but not due to a vaccine, she was diagnosed with COVID on 18Dec2020 (she was off quarantine as of 28Dec2020, going back to work on 31Dec2020). When she was diagnosed with COVID, it caused an asthma exacerbation and she needed a 5-day oral burst of 40 mg prednisone. Concomitant medications were none. On 11Jan2021 the patient experienced temperature elevated, at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain and she was very achy. Her temperature started last night (11Jan2021), temperature was 99.8. She tried to hydrate. She also had a temperature at 6 AM on 12Jan2021 morning. On 12Jan2021 she had temperature of 101.8 and this was after taking antipyretics 6 hours before. Then, on 12Jan2021, her temperature was 101. She was on the phone with her primary care provider and she was told to take more antipyretics. She just took more antipyretics. She stated it felt almost like they hit a nerve when administering the vaccine since she was experiencing shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand. She believed, based on anatomy, that there were nerves going right there. She knew she was overweight but her upper arms were not that bad. She tried to take a shower to cool herself down. She received the vaccine through pharmacy since she was working at a long term care facility around COVID. Pharmacist came to the long term care facility where she works to administer the vaccine. The events did not require ER visit. Relevant tests: none. Fever outcome was unknown. The other events had not yet resolved. Sharp shooting pain came and went. The reporter considered all the events serious as medically significant and related to BNT162B2 vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-01-21 feeling hot, weakness, depressed level of consciousness I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm... Read more
I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-21 migraine Injection 1-muscle soreness for about 8 hrs at site and headache for a couple days. Injection 2- m... Read more
Injection 1-muscle soreness for about 8 hrs at site and headache for a couple days. Injection 2- muscle soreness at site, migraine that evening, and severe neck pain. Muscle pain in neck and shoulders for a few days causing ha?s in the evenings.
40 2021-01-21 pain in extremity 5PM - SORE ARM (UNABLE TO LIFT) 4AM - CHILLS 2PM - FEVER 101.2 TOOK TYLENOL
40 2021-01-21 tingling Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and acr... Read more
Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and across her upper back. She had taken a dose of Benadryl, 50 mg p.o. prior to coming to the clinic, due to her prior history of allergies. Her blood pressure was checked in left arm, 134/94. She denied chest pain, SOB or feeling of swelling in tongue or face. After the tingling sensation, she began to experience pruritus of her arms, back and scalp. Visual inspection revealed no visible rash or hives. When she began rubbing on her left arm to relieve the itchy sensation, the area of rubbing became erythematous. She was observed for 45 minutes after the injection. Symptoms did not progress and she was discharged from the clinic. Phone follow-up 24 hours later: pruritus has resolved. She took 2 more doses of Benadryl 50 mg p.o. yesterday, at 2 p.m. and 11 p.m. Only symptom reported today is sleepiness.
40 2021-01-22 weakness, cold extremities Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak... Read more
Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat
40 2021-01-22 feeling cold Severe Headache, body aches, cold chills
40 2021-01-22 muscle spasms A few hours after the infection, I started having small muscle spasms all over, like little pulsatio... Read more
A few hours after the infection, I started having small muscle spasms all over, like little pulsations throughout my whole body, especially in legs and arms. They weren't intense or painful, but still unsettling. It's been happening daily, and has subsided a little but it's still happening 5 days later. Also have very sore and tight leg muscles. I don't know if this is considered "adverse enough", but it's still concerning, as muscle spasms are not mentioned in the common side effects, and because it has not stopped completely.
40 2021-01-22 pain in extremity 1/19 arm sore 1/20 achy 1/22 tightness in chest
40 2021-01-23 migraine Headache before and during, progressed to migraine the next morning 1/22, better 1/23 and feels fine... Read more
Headache before and during, progressed to migraine the next morning 1/22, better 1/23 and feels fine today 1/24
40 2021-01-24 feeling hot beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea,... Read more
beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea, feeling warm -- temp of 100.7; chills, fever, and nausea all morning of 1/21/21; fever and chills continued through 1/22/21 around 11am. Treated with Tylenol and Zofran. On 1/22/21 noticed lymph node swelling on arm where vaccine given. Neuropathy 1/22/21. Treated wtih ibuprofen 600mg TID. Lymph node remains swollen as of 1/25/21. Lymph node is hard.
40 2021-01-24 pain in extremity Extreme fatigue body aches chills sore and swollen arm
40 2021-01-24 throat numbness Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst... Read more
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
40 2021-01-24 sensory loss, numbness On December 29th, I developed acute bilateral numbness of my fingers. This lasted for about 45 minu... Read more
On December 29th, I developed acute bilateral numbness of my fingers. This lasted for about 45 minutes, but since then, has remained as loss of sensation in all 10 of my fingertips.
40 2021-01-25 weakness Fever, chills, myalgias, fatigue, generalized weakness , starting 12 hours after the vaccination and... Read more
Fever, chills, myalgias, fatigue, generalized weakness , starting 12 hours after the vaccination and lasting approximately 24 hours, except fatigue lasting 2-3 days
40 2021-01-25 feeling hot, tingling a flood of heat throughout my body; pain in my calf muscle; tingling; Woke me up all night; super di... Read more
a flood of heat throughout my body; pain in my calf muscle; tingling; Woke me up all night; super dizzy; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 12Jan2021 10:00 at a single dose for COVID-19 immunization. There were no medical history. The patient is not pregnant. Concomitant medication included amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced super dizzy on 12Jan2021 10:06, a flood of heat throughout her body, pain in her calf muscle, tingling, and it woke her up all night on 12Jan2021 12:00. Outcome of the events was recovering.
40 2021-01-25 feeling hot On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and starte... Read more
On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and started having intense, crushing pain in my CTL back (with the worst of it being in my thoracic and lumbar areas). *The nausea and subsequent dry heaving subsided within 6-8 hours with prescribed anti nausea. *The back pain only intensified, with me finally calling my doctor who recommended contacting ONE Parkview. This back pain continues today (1/26/2021). On 1/21/2021, in the early hours of the morning, I woke to hives over my entire trunk, left arm (injection site), and left thigh. *This subsided in maybe 10 or so hours with antihistamines. On 1/23/2021, at approximately 1100, I felt heat in my left arm. This coincided with a heavy feeling in my left arm. When examined, I noted that my upper arm was slightly swollen, blotchy, and had a reddened rash approximately 4x4 inches. Minor itching. *The swelling subsided by 1/25/2021, but the heat and reddened rash continues today (1/26/2021).
40 2021-01-25 numbness, tingling 5 minutes after I received the shot my left pinky finger and left ring finger went numb. I notified ... Read more
5 minutes after I received the shot my left pinky finger and left ring finger went numb. I notified the nurse. She left to get the head nurse. Within 2 minutes my arm was numb below my elbow. This lasted 10 minutes. The feeling came back. Later that day my left upper back was sore. Since then (2 weeks) I still have numbness and tingling in my elbow and left pinky finger with occasional pain in my left upper back.
40 2021-01-25 numbness Numbness of all 10 toes
40 2021-01-25 migraine nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigo... Read more
nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigors; nasal stuffiness; chest congestion; wet cough; This is a spontaneous report from a contactable physician. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1283), intramuscular on 08Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had the first dose last 18Dec2020 (lot number=EJ1685). The patient experienced nuchal rigidity, migraine, photosensitivity, auditory sensitivity, arthralgia, lethargy chills, rigors, nasal stuffiness, chest congestion, wet cough on 09Jan2021 05:00. The outcome of the event nuchal rigidity was not recovered while other events were recovered with sequelae.
40 2021-01-25 pain in extremity, numbness Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; Thi... Read more
Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; This is a spontaneous report from a contactable health care patient. This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 11Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. Medical history included frequent migraines, anxiety and anemia. Historical vaccine included first dose of BNT162B2 (Lot # 1), intramuscular left arm, on 21Dec2020 at 07:30 AM for COVID-19 immunisation. Age at vaccination was 40-years-old for both doses. Concomitant medications included topiramate (TOPAMAX), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE DAY VITAMINS), phentermine, phendimetrazine tartrate (BONTRIL), naproxen sodium (ALEVE), escitalopram. On 11Jan2021 at 12:00 PM, the patient experienced face numbness, headache, fatigue, legs aching, muscle soreness in the left arm, and rapid heartbeat. No treatment was received for the event. Outcome was recovering. Information on the lot/batch number has been requested.
40 2021-01-25 tremor, weakness I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I ... Read more
I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.
40 2021-01-26 weakness, slurring Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and sync... Read more
Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and syncope. Symptoms progressed over time until she seemed almost catatonic at times including delayed responses, staring straight ahead (later she closed her eyes), slurred speech. She kept repeating, "I feel like jelly" and that she was very tired. Pharmacist gave her 25 mg diphenhydramine at 10:55 am. Around 11:10 the facilities administer called 911 at the request of (PharmD).
40 2021-01-26 weakness, feeling of insects crawling on skin heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs cr... Read more
heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.
40 2021-01-26 weakness Dizziness, fatigue, nausea and vomiting, fever of 102. Felt very weak for 24. Dizziness remained aft... Read more
Dizziness, fatigue, nausea and vomiting, fever of 102. Felt very weak for 24. Dizziness remained after other symptoms resolved.
40 2021-01-26 feeling cold, pain in extremity RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AR... Read more
RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AROUND 2AM I WOKE UP WITH A FEVER (99F), CHILLS, BODY ACHES, SORENESS IN LEFT ARM AND LEFT SIDE OF NECK, HEADACHE, NAUSEA & VOMITTING. I TOOK 4 X 200MG IBUPROFEN. I FINALLY WAS ABLE TO SLEEP AGAIN AROUND 7AM. I HAD A HEADACHE, BODY ACHES, NAUSEA AND FATIGUE THROUGH THE REST OF THE DAY. I SLEPT MOST OF THE DAY. AFTER 48 HOURS MOST SIDE EFFECTS WERE GONE, EXCEPT FATIGUE AND SORENESS IN LEFT ARM AND SIDE OF NECK.
40 2021-01-26 feeling hot, weakness Case received dose at 11:25 am and at 12:25 pm felt a rush of heat throughout her body, back of thro... Read more
Case received dose at 11:25 am and at 12:25 pm felt a rush of heat throughout her body, back of throat "fuzzy", heart rate 140/min for 20 minutes. Her breathing was as if she was "trying to catch my breath" which lasted 5 minutes. At 1pm she experienced fatigue, chills, had fog, and weakness which lasted or approximately 18 hours. She felt much better 48 hours later.
40 2021-01-26 flushing, feeling hot About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no ap... Read more
About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no apparent angioedema), itching and warmth of the face and chest. Her face and upper chest did appear flushed. She was administered Benadryl, and her symptoms resolved after half an hour.
40 2021-01-26 numbness Pt received vaccine at 1611 to the left arm then waited 15 for minutes in the observation area. She ... Read more
Pt received vaccine at 1611 to the left arm then waited 15 for minutes in the observation area. She then stared to drive herself home and developed numbness to the right lateral face and right neck. She came back the vaccine site and had numbness to her left lateral face. She was was without edema, impaired vision, talking, swallowing and her neuro exam was normal.
40 2021-01-26 pain in extremity I had soreness in my arm the day after the first injectionbut no other adverse events after the firs... Read more
I had soreness in my arm the day after the first injectionbut no other adverse events after the first injection; This is a spontaneous report from a contactable Other-HCP (patient). This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EH9899), via an unspecified route of administration on 18Dec2020 14:45 at single dose on the right arm for COVID-19 immunization. The patient's medical history included allergies: Cephalosporin (mild reaction of hives one time after having taken it with no issues for years). There were no concomitant medications. No other vaccine received in four weeks. Facility type vaccine was hospital. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient had soreness in her arm the day after the first injection but no other adverse events after the first injection. No treatment received. Outcome of the event was recovered.
40 2021-01-27 weakness weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy;... Read more
weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-01-27 discomfort, pain in extremity Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while re... Read more
Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while recalling information in a conversation; Feverish feeling but no fever; Heaviness of the body like moving in honey; Achiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248, expiration date not reported) via an unspecified route of administration on the right arm on 12Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included PCOS, Raynauds, PTSD; and known allergies: Sulpha, sulfites, pseudafed, penicillin, cephalosporins, bromfed, IV contrast, pineapple. Concomitant medication in two weeks included levocetirizine dihydrochloride (XYZAL), omeprazole, escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL) and levothyroxine sodium (LEVOTHYROXIN). On 12Jan2021 08:45 PM, the patient experienced both arms hurt, fatigue, achiness, headache that moves, ear aches, noises are louder, mind goes blank while recalling information in a conversation, feverish feeling but no fever, heaviness of the body like moving in honey. Therapeutic measures were taken as a result of the events which included Ibuprofen (ADVIL) and acetaminophen (TYLENOL). The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
40 2021-01-27 pain in extremity On 1/22, I noticed a painful red itchy bump on my left foot. Another bump appeared on my right inde... Read more
On 1/22, I noticed a painful red itchy bump on my left foot. Another bump appeared on my right index finger the day after, and then another bump appeared today 1/28 under my right arm. They are getting larger, more painful and swollen, itchier, and seem to be filled with white pus. The one on my left foot has burst.
40 2021-01-27 tingling, numbness, pain in extremity Approximately 45 minutes after I received the shot, the index finger and thumb of my left hand went ... Read more
Approximately 45 minutes after I received the shot, the index finger and thumb of my left hand went completely numb and my index finger turned almost white. The numbness subsided about 20 minutes later but my fingers were tingly and hurt. Shortly thereafter, my left toes were also tingly and numb. By that evening, my right hand and foot were also experiencing tingling and numbness and by the next morning my legs and arms bilaterally were experiencing the same sensations. My upper right back is also involved, with a central area radiating the pins/needles feeling with soreness around it almost like a backache. The severity and location of the pins/needles/numbness changes. For example, when I was taking a walk earlier, my feet and hands increased significantly with the pins/needles feeling and receded some as I was at rest. As I am typing now, my hands, upper back, and lower right leg are the most noticeable with the tingling. I have taken some Benadryl, which reduces the sensations some but does not take it away entirely. I am now three days post injection, and I am concerned that I am experiencing an allergic reaction of some sort that is affecting my nervous system.
40 2021-01-27 seizure like phenomena employee became light headed, dizzy and nauseous. 10-15 min after vaccine. 0956 vitals were taken a... Read more
employee became light headed, dizzy and nauseous. 10-15 min after vaccine. 0956 vitals were taken and employee was asked to lay down on cot (vitals 143/83 p 90) 1003 employee began to have seizure like activity a rapid response was called at 1008. Employee refused to go to ED , husband notified. 1020 Benadryl was given per MD continued monitoring until 1135 employee was recommended to go to ED by MD , she refused stated she was ok just tired. Assisted to vehicle with husband at 1140
40 2021-01-28 flushing Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respira... Read more
Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respiratory issues. Patient chose to leave facility and went to a store where she purchased Benadryl and took 25mg orally. Patient returned to site where vaccine was given (which is also her place of employment). Nurse evaluated patient and rash noted on chest. Blood pressure elevated to 220/115 and heart rate 120. Physician evaluated patient. EKG performed and patient found to have sinus tachycardia. Benadryl 25mg and Kenalog 40mg administered intramuscularly. Blood pressure came down to 150/104 which patient reported was close to her recent baseline as she recently had a medication adjustment. After approximately 15 minutes patient no longer felt flushed. Patient was instructed to take and additional dose of Benadryl 50mg orally that evening and a Prednisone dose pack was prescribed.
40 2021-01-28 hot flush, feeling cold My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I ha... Read more
My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I had bronchitis two weeks prior next day cough wheezing completely gone and my lungs feel great I can breathe again with no mucus I have swollen lymph nodes but not to bad little headache but overall feeling ok just tired and some dizziness at times.
40 2021-01-28 numbness, tingling Facial numbness and tingling; Facial numbness and tingling; This is a spontaneous report from a cont... Read more
Facial numbness and tingling; Facial numbness and tingling; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on the right arm on 08Jan2021 at 07:15 at a single dose for COVID-19 immunization. Medical history included anemia, Vitamin D deficiency, and known allergies to dairy and kiwi. Concomitant medication included iron (IRON), colecalciferol (VITAMIN D [COLECALCIFEROL]), zinc (ZINC), linum usitatissimum oil (FLAXSEED OIL [LINUM USITATISSIMUM OIL]), and cetirizine (CETIRIZINE). The patient had no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, on the right arm on 19Dec2020 at 0745AM for COVID-19 immunization. The patient had no COVID prior vaccination and had not tested for COVID post vaccination. The patient experienced facial numbness and tingling on 08Jan2021 at 08:15. No treatment was administered for the events. The events resolved on an unknown date in Jan2021.
40 2021-01-28 pain in extremity Vaccine taken at 6:30 am. Soreness in left arm started around 8-8:30. Felt tired all day but after a... Read more
Vaccine taken at 6:30 am. Soreness in left arm started around 8-8:30. Felt tired all day but after a nap around 11:30ish felt nauseous, ate to try and calm it but it got worse throughout the day especially at night around 9pm finally relaxed enough to fall asleep, woke up at 7am feeling more nauseous than yesterday with a bad headache located in the front of my head not throbbed but constant. Laying down just felt really sick so I called my doctor around 9:15am.
40 2021-01-28 pain in extremity Day 2 after injection just injection site pain and tired. Severe hips/knees/ankles/wrists/back pain ... Read more
Day 2 after injection just injection site pain and tired. Severe hips/knees/ankles/wrists/back pain on day 5 and 6 after injection and calves pain and tightness.
40 2021-01-28 cold extremities on left arm, almost immediately after left hand became increasingly cold; This is a spontaneous repo... Read more
on left arm, almost immediately after left hand became increasingly cold; This is a spontaneous report from a non-contactable Other-HCP reporting for herself. A 40-years-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on arm left from 14Jan2021 07:00 to 14Jan2021 07:00 at SINGLE DOSE for covid-19 immunisation. Medical history included Prolonged QT syndrome. The patient's concomitant medications were not reported. The patient had her first dose of BNT162B2 on 23Dec2020 to 23Dec2020. On 15Jan2021 at 07:00, on left arm, almost immediately after left had became increasingly cold. Right had was ok and did not change in temperature. Area around the shot was not cold, only hand. Coldness lasted for about 15 minutes before slowly getting back to normal temperature. The patient had not received any treatment for the event. The patient was not pregnant at the time of the report. Outcome of the event was recovered on an unspecified date. No follow up attempts are possible, information about lot/batch number cannot be obtained.
40 2021-01-28 trigeminal neuralgia Right sided trigeminal neuralgia; This is a spontaneous report from a contactable physician. A 40-ye... Read more
Right sided trigeminal neuralgia; This is a spontaneous report from a contactable physician. A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at the right arm, on 09Jan2021 13:30 at a single dose for COVID-19 immunization. at a clinic Patient was generally healthy, though has history of migraines, symptoms were not typical of migraine and dairy allergy that has resolved, no current allergies. Patient is not pregnant. Concomitant medication included colecalciferol (VITAMIN D), calcium, sumatriptan, cetirizine hydrochloride (ZYRTEC), and fish oil, vitamin e nos (OMEGA 3). Patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9899), intramuscular at the left arm, on 19Dec2020, 09:15. The patient experienced right sided trigeminal neuralgia on 10Jan2021 06:00, began 17 hours post 2nd dose vaccine and lasted 24 hours in duration. No history of this condition. Self resolved. Most likely diagnosis confirmed by neurology colleague, though definitive testing was not able to be done due to short duration of symptoms. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient recovered from the event.
40 2021-01-29 burning sensation Pt received her first pfizer vaccination and after approximately 10 minutes, pt started itching thro... Read more
Pt received her first pfizer vaccination and after approximately 10 minutes, pt started itching throughout her entire body and burning to her perineal area. SQ Epi given on scene and IV benadryl given in route by EMS.
40 2021-01-29 numbness Patient c/o slight numbenss at the injection site and to the back side of the arm along with feeling... Read more
Patient c/o slight numbenss at the injection site and to the back side of the arm along with feelings of queasiness. Ears were flush, no redness noted at the injection site or arm after fifteen minutes. Pt was able to lift her arm and hold it without any difficulty. Pt reported not eating anything this morning before recieving the vaccine. Pt allowed to lie down and monitored for 15 more minutes. Pt verbalized that she felt better after the additional 15 minutes, ears were with in normal color.
40 2021-01-29 pain in extremity Fever 101, chills, body aches, headaches, sore arm
40 2021-01-31 pain in extremity chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot... Read more
chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot do her daily duties/ could not even put her seat belt or roll up the window in her car; extreme headache; received first dose of the vaccine on 24Dec2020/the second dose on 11Jan2021; Chills; feeling horrible/feels foggy; feeling tired/ exhausted; body aches; arm was really sore; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), intramuscularly on 11Jan2021 07:45 at single dose in left arm to prevent covid, since she worked in a hospital with covid patients. Medical history provided as none. There were no concomitant medications. She gets the flu vaccine annually. The patient previously received first dose of BNT162B2 vaccine intramuscularly on 24Dec2020 23:45 in left arm for COVID-19 immunization with no adverse events. There were no other prior Vaccinations within 4 weeks. The patient experienced chills on 11Jan2021, feeling horrible on 11Jan2021, extreme headache on 12Jan2021, chest discomfort/something heavy on her chest on 13Jan2021, feeling tired/ exhausted on 11Jan2021, chest discomfort, feeling tired/ exhausted was reported as worsened; body aches on 11Jan2021, feels foggy on 13Jan2021, arm was really sore on an unspecified date in Jan2021, cannot even get out of bed on 12Jan2021. Specifically, it was reported that the patient worked 12 hours overnight, she slept and when she woke up she felt chills and felt horrible. States it carried on 12Jan2021. Today on 13Jan2021 she has an extreme headache, she clarifies the headache started on 12Jan2021 (yesterday). She feels like something heavy on her chest, chest discomfort. She has body aches and feels tired. She cannot cook right, she is so exhausted and cannot do her daily duties. She is assuming it is the immune reaction. Her son told her she looks really sick. States she rarely gets sick and when she gets sick she does get chills. Her chest feels like something is heavy on her. States if she did not have a strong heart, she cannot imagine what someone that does not have a strong heart would feel like. Since she works in a hospital she deals with covid all year around and she has been strong and healthy this year. Reports her headache is strong and today on 13Jan2021 she feels foggy. States yesterday on 12Jan2021, she was horrible and today (13Jan2021) is better in regards to chills. Her arm was really sore and now her arm is better, she could not even put her seat belt on 12Jan2021 (yesterday) or roll up the window in her car. She is nervous about the chest discomfort and headache. Asking where it could be coming from. She thinks it could be a possible immune response. If the chest discomfort continues she will go get seen. Advised to contact hcp. States she feels like crap. States she never gets headaches. Yesterday on 12Jan2021, her body aches were horrible and she cannot even get out of bed. The outcome of events chills, body aches was recovering, outcome of events extreme headache, chest discomfort/something heavy on her chest, feeling tired/ exhausted was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.
40 2021-01-31 pain in extremity Several hours after getting 2nd dose, left arm very painful. The next morning she woke up and had in... Read more
Several hours after getting 2nd dose, left arm very painful. The next morning she woke up and had increase in arm pain, not able to move it, body aches, chills, nausea, and fatigue. symptoms remain today.
40 2021-01-31 pain in extremity Pain, swelling and large bump in left arm. Pain down in left hand.
40 2021-02-01 weakness Elevated temperature (almost 100); Feel weak and shaky; Feel weak and shaky; Coughing; Nasal congest... Read more
Elevated temperature (almost 100); Feel weak and shaky; Feel weak and shaky; Coughing; Nasal congestion; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccine location: left arm) on 20Jan2021 11:45 for COVID-19 immunization. Facility where the recent COVID-19 vaccine was administered: Other-Drive thru vaccine POD. Medical history included Hashimoto's thyroiditis, allergies to penicillin, and sinus infection. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Other medication the patient received within 2 weeks of vaccination included doxycycline 'hydroxylate' for a sinus infection. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021 12:00, the patient had an elevated temperature (almost 100), felt weak and shaky, coughing and nasal congestion, and a headache. The events were considered as non-serious by the reporter. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events. No follow-up attempts are possible; information about batch number cannot be obtained.
40 2021-02-01 feeling hot, pain in extremity, feeling cold I felt extremely hot/cold sensation in a claustrophobic; I felt extremely hot/cold sensation in a cl... Read more
I felt extremely hot/cold sensation in a claustrophobic; I felt extremely hot/cold sensation in a claustrophobic; nauseous; Dizzy; headache; fatigue/I'm just exhausted 72 hours later; fever kept rising; I started violently projectile vomiting for a few hours; I got the chills; I was sore; felt "hungover"; the arm soreness; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her right arm, intramuscular on 16Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included anxiety, acid reflux and cholecystectomy. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), clonazepam (CLONAPAM) and an unspecified antacid. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 as first dose. It was reported that 12 hours later after vaccination, the patient felt really hot and nauseous, dizzy, headache and fatigue. But then 24 hours later her fever kept rising. She felt extremely hot/cold sensation in a claustrophobic. At peak of her fever, 100F, she started violently projectile vomiting for a few hours. Then she got the chills. Felt nauseous still. But no more vomiting, fever went down on its own. The next day 48 hours later, she was sore and felt "hungover". This time the arm soreness dissipated twice as fast. Now she just exhausted 72 hours later; all events occurred on 17Jan2021 at 02:00. No treatment was received for the events. The outcome of the events was recovered with sequel.
40 2021-02-01 flushing, feeling hot bilateral hand swelling, flushing of neck and face, feeling hot. Alert and oriented x4, epi-pen to l... Read more
bilateral hand swelling, flushing of neck and face, feeling hot. Alert and oriented x4, epi-pen to left thigh, Benadryl 50 mg PO, reduced hand swelling, T97.8 F BP 151/91 SpO2 99% P78. 911 was called, staff assessed pt, did not transport. Pt had friend transport to ER in private vehicle to seek higher level of care as a precaution.
40 2021-02-01 flushing Two days post-injection patient developed a red rash across the neck that has not subsided. Patient ... Read more
Two days post-injection patient developed a red rash across the neck that has not subsided. Patient States that rash is flush red and itchy since time of the injection.
40 2021-02-01 numbness, sensory loss My the skin of my jaw and chin started to feel numb. The sensation progressed rapidly to include nu... Read more
My the skin of my jaw and chin started to feel numb. The sensation progressed rapidly to include numbness of my cheeks, eyebrows, and ears. The symptoms appeared rapidly after leaving the clinic (as I was driving away on my from work to home). Less than 30 minutes after receiving the vaccine. Both sides of my face were impacted equally.
40 2021-02-01 numbness Fainted, legs and arms went numb and my hands froze, felt almost like a stroke. Was ok after about 3... Read more
Fainted, legs and arms went numb and my hands froze, felt almost like a stroke. Was ok after about 30 minutes,,was just very tired rest of day
40 2021-02-01 migraine Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was d... Read more
Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was diluted incorrectly with less Normal Saline than require. This error was not noticed until person mixing vaccine said they were out of vaccine and did not have enough to get 5 dosages of 0.3ml. Two people mixed one vial of vaccine together demonstrating to the other. It appears the person making the error did not notice they did not have 1.8ml of NS but must have had some air and did not realize it. The error was noticed when all the vaccines were given and one person had not completed pulling up the vaccine. So, 2 of 7 patients received the incorrect dose of vaccine and it could not be determined which two received the incorrect dose. Patient Reports: fatigue, body aches, persisting migraine headaches
40 2021-02-01 pain in extremity Around 6 am,( day after vaccine- approximately18 hrs after vaccine) achy legs, fever, sore arm(left ... Read more
Around 6 am,( day after vaccine- approximately18 hrs after vaccine) achy legs, fever, sore arm(left arm), fatigue, headache. Lasted approximately 12 hours
40 2021-02-01 tingling, numbness Approximately 25-30 minutes after receiving the vaccine, my lower jaw and face began to tingle and f... Read more
Approximately 25-30 minutes after receiving the vaccine, my lower jaw and face began to tingle and felt numb and swollen. A few minutes after that began, the back of my throat was scratchy. I took Benadryl 30 minutes after symptoms began and within 45 minutes all symptoms resolved. 7 hours following the Benadryl dosing, the symptoms returned. I took another dose of Benadryl. The symptoms resolved and did not return.
40 2021-02-01 tingling, numbness Left side facial numbness and tingling. tongue numbness. left eye blurred vision. Symptoms stayed... Read more
Left side facial numbness and tingling. tongue numbness. left eye blurred vision. Symptoms stayed active for 24-48 hours
40 2021-02-02 electric shock sensation Currently 25 2/7 weeks; started having night terrors 1/28/21; also accompanied with ?brain zingers? ... Read more
Currently 25 2/7 weeks; started having night terrors 1/28/21; also accompanied with ?brain zingers? small electrical shocks in my brain that last 1-2 seconds but are definitely not something I can ignore. I get approximately 4-5 zingers an evening.
40 2021-02-02 flushing Patient felt flushed and experienced shortness of breath (history of anxiety, panic attacks). Drank ... Read more
Patient felt flushed and experienced shortness of breath (history of anxiety, panic attacks). Drank water and felt better in 10 minutes.
40 2021-02-02 numbness, tingling, difficulty speaking tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles o... Read more
tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
40 2021-02-03 feeling cold, tremor December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Mond... Read more
December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.
40 2021-02-03 numbness, tingling, pain in extremity, numbness and pain in extremities 12/30/2020: COVID Vaccine Pfizer-BioNTech dose 1 of 2 left arm. Acute onset left shoulder/arm pain 1... Read more
12/30/2020: COVID Vaccine Pfizer-BioNTech dose 1 of 2 left arm. Acute onset left shoulder/arm pain 1-2 days later without inciting event (no trauma, no sports/weights), progressively worsening to severe next 2 days with onset of numbness and paresthesias in left upper arm and hand by 1/5/2021 seen at urgent care with dx: Cervical Neuropathy. Follow-up cervical MRI 1/22/21 without significant canal or foraminal impingement. Seen by Neurologist 2/3/2021, at that time pain improved and localized to left shoulder joint area radiating under scapula and paresthesia resolved to numbness. Physical exam findings: Absent triceps reflex, Left FDI atrophy, left hand finger extensor weakness, left abduction limited to 90 degrees. Dx: Neurologic Amyotrophy (Parsonage Turner Syndrome); Complication of COVID vaccination. Plan: EMG, NCS, Left shoulder MRI, labs pending. PT OT ordered. Rx: Nortriptyline, Medrol Dosepak. F/U 2-3 months with neurology.
40 2021-02-03 pain in extremity Report left arm soreness and HA 6 hours after vaccination: Treatment: Tylenol with no improvement. O... Read more
Report left arm soreness and HA 6 hours after vaccination: Treatment: Tylenol with no improvement. Outcome: unable to go to work, but does not interfere with ADLs.
40 2021-02-04 weakness felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was... Read more
felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
40 2021-02-04 pain in extremity After - about 3 hours later: sore arm - lasted two days. On 28th, I started getting a runny nose; co... Read more
After - about 3 hours later: sore arm - lasted two days. On 28th, I started getting a runny nose; coughing and sneezing and sore throat. That kept going for a few days. On 30th, I found out I was exposed to someone that had COVID. 30th was tested and results on 31st - positive. I went to URGENT Care to get the test. Albuterol inhaler was prescribed; and an Antibiotic for my symptoms. She told me not to start the medication until I found out that I was positive or not. So I started the meds on the 31st. I got sicker before I got better - got chills and sweating (back and forth); felt really tired and out of energy and had brain fog and I tripped on things in front of me. I didn't have any appetite. Had to force myself to eat so I could take my medicine - for about a week. I was coughing a lot. Took over the counter cough medicine especially night because it was disturbing my sleep. Later, I had a telehealth appt with my primary care dr appt - on January 8th. And she prescribed a steriod inhaler - Budesonide Formoterol Fumarate Dihydate- inhalation aerosol and I'm still taking that today because I still have a cough. Had the second dose of the vaccine on January 26, 2021 at 6:30PM. No reaction to that dose except sore arm.
40 2021-02-04 tingling, numbness 45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and fe... Read more
45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and feet, progressing to the knees. Injection site warm, BP 132/96. On exam, oropharynx mild erythema - no edema and no stridor. Lungs CTA. Cor - S1 S2 slightly rapid. Abd soft, non-tender, positive BS. No rashes. Gave Benadryl 50 mg and prednisone 20 mg. BP 110/72. HR 72. O2 Sat 98%. Temp 98.3F.
40 2021-02-04 tenderness, discomfort Shortly after the vaccination I was still having the abdominal distention so I called to see if I co... Read more
Shortly after the vaccination I was still having the abdominal distention so I called to see if I could defer the 2nd vaccine because I wasnt feeling well and still experiencing AE from the 1st dose. I was advised I still had to get the vaccine so I did and by 2:30pm I begin to have severe facial swelling causing asymmetrical shaping of my face, my head was hurting extremely bad, fatigued and felt really bad. I had to lay down because my head was hurting, felt like I had pressure on the top of my head, neck and back. The pain was so bad I was transported to the ER and was isolated d/t previous COVID infection and all while there the my body felt as if it was steady swelling. I was hurting so bad I couldnt stand to be touched. I was given another round of steroids. I was advised I had COVID pnemonia and was given IM decadron, IM regalin and a subQ injection of immatrex for the headaches and administered ibuprophen and tynenol for the headache as well. I was discharged with a prescription of regalin and decadron. The ER dr. states I shouldnt have taken the 2nd vaccine because I was still suffering from COVID-19. The abdominal distention had dissolved but the congestion just will not clear up even after 3 rounds of steroids. Asoumedrol was prescribed by my ENT but it didnt help either so I have a CT Scan scheduled for next week with my ENT and has not been able to return to work since the 1st dose 12/22. I have be retested for COVID-19 on both 1/15 and 1/25 and both results are still positive for COVID.
40 2021-02-04 tenderness Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under ey... Read more
Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-02-06 pain in extremity Sore arm 36 hours later, muscle aches, joint aches, headache I only wanted to report these because ... Read more
Sore arm 36 hours later, muscle aches, joint aches, headache I only wanted to report these because I had Covid in October 2020 and had this response on my second dose of the vaccine.
40 2021-02-07 numbness, tingling Symptoms: c/o tingling and numbness to left hand 3rd, 4th, 5th digits. Intervention: VS BP 162/108 ... Read more
Symptoms: c/o tingling and numbness to left hand 3rd, 4th, 5th digits. Intervention: VS BP 162/108 HR 85 O2sat 99% on RA, respirations 12. Patient states she is getting a work up from PCP regarding elevated BP. Advised to follow up w/ PCP. States no worsening of symptoms. No c/o dizziness, feeling of faintness. Able to ambulate and exit vaccine clinic w/o incident.
40 2021-02-07 tingling, weakness, tremor inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were ... Read more
inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were swollen; both legs were tingly; dizzy; very weak; shaky; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included asthma, mitral valve, Known allergies: Sulfa, Shellfish, sulfide. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR) and Asthma inhalers. 6 hrs after vaccinated I became dizzy, very weak and shaky. Next day was nauseated all day, felt shaky, by 3 pm temp was 102, had heart rate in 150's. Both my knees were swollen, both legs were tingly. I took Motrin and Tylenol and most symptoms resolved by morning. Friday morning, I still felt weak but other symptoms resolved. I was not expecting the inflammatory response which is why I am letting y'all know. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: negative on 21Jan2021. The outcome of the event Very weak not recovered, inflammatory response was unknown and of the rest events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
40 2021-02-07 tingling tingly fingertips
40 2021-02-08 feeling hot, tingling, flushing Had a flushing reaction to first vaccine. and 5 minutes after second vaccine (2/5/21 ) started havin... Read more
Had a flushing reaction to first vaccine. and 5 minutes after second vaccine (2/5/21 ) started having facial flushing, warm and tingling sensation. Went to urgent care.
40 2021-02-08 feeling hot 10:32 : FELT FATIGUED, SWEATY, QUEASY, 'HOT"- POST VACCINATION VS: T: 98.2, P: 72; BP: LEFT ARM... Read more
10:32 : FELT FATIGUED, SWEATY, QUEASY, 'HOT"- POST VACCINATION VS: T: 98.2, P: 72; BP: LEFT ARM: 150/98; RT. ARM: 152/100. has hypertension, has not been taking her BP meds for over 1 month.
40 2021-02-08 numbness, tingling hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she f... Read more
hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.
40 2021-02-08 numbness Patient is having muscle pain in both arms and her neck since the second vaccination. She says her r... Read more
Patient is having muscle pain in both arms and her neck since the second vaccination. She says her right hand goes numb, and both grips are intermittently weak. She says she has gotten sharp stabbing pain in left arm, (shot was in right). Has indicated that it doesn't seem to be resolving. I told her to go see her primary and that we would notify the "CDC."
40 2021-02-08 migraine on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrh... Read more
on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrhea, fever 99.8. Did not feel well through 2/8/2021.
40 2021-02-08 tingling, numbness numbness and tingling that began about 7 hours ago. She describes it as a "pins and needles" feeling... Read more
numbness and tingling that began about 7 hours ago. She describes it as a "pins and needles" feeling in her hands with numbness in her face and intermittent left sided lip twitching. She denies any numbness or tingling in BLE. She reports having a significant headache since receiving the first dose of the COVID-19 vaccine 9 days ago and some muscle aches. She also reports some dizziness which she describes as lightheadedness, but denies any LOC
40 2021-02-09 weakness headache, dizziness, weakness and runny nose
40 2021-02-09 breast pain Headache Extreme; fatigue; Pain at injection site; armpit and breast (all L) Ncek pain; armpit and b... Read more
Headache Extreme; fatigue; Pain at injection site; armpit and breast (all L) Ncek pain; armpit and breast (all L) Neck pain; armpit and breast (all L) Neck pain; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 19Jan2021 15:00 for an unspecified indication Covid-19 immunisation. Medical history included irritable bowel syndrome (IBS), asthma, allergies to sulfa. Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. On 20Jan2021 the patient experienced headache extreme, fatigue, pain at injection site, armpit and breast (all l) neck pain. No treatment received. COVID was not tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-02-09 flushing Systemic: Other- chest tightness, flushing, and signs of panic
40 2021-02-09 flushing Raised rash on face; Raised rash on face and injection site; flushed feeling face; chills; Body ache... Read more
Raised rash on face; Raised rash on face and injection site; flushed feeling face; chills; Body aches; brain fog/ overall not up to feeling like myself; This is a spontaneous report from a contactable nurse reported for herself. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the right arm on 22Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing and cerebrovascular accident from an unknown date and unknown if ongoing. The patient previously took morphine and experienced drug hypersensitivity. On 23Jan2021 10:30, the patient experienced raised rash on face and injection site, flushed feeling face, chills, overall not up to feeling like myself, body aches and brain fog. No treatment was received for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
40 2021-02-09 numbness Numbness at the right side of face and neck; where I was administered I waited 30 minutes and I star... Read more
Numbness at the right side of face and neck; where I was administered I waited 30 minutes and I started feeling like it move across my face; This is a spontaneous report from Pfizer sponsored program from a contactable nurse (patient). A 40-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9263, intramuscular in the right deltoid on 23Jan2021 05:18 am at single dose for covid-19 immunisation. Medical history included asthma, Sjoegren's syndrome and anxiety, all from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA). Historical Vaccine included first dose BNT162B2 for COVID-19 immunization. The patient said that she was still experiencing numbness at the right side of her face and neck after taking the second dose of the COVID-19 Vaccine. She stated she literally drove away from the injection (not clarified) or where she was administered she waited 30 minutes and she started feeling like it move across her face. As to start date of the event the nurse stated that's today 23Jan2021. There was no treatment received. The outcome of the event was not resolved. Relatedness of suspect to event was reported related.
40 2021-02-09 migraine, feeling hot uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; t... Read more
uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.
40 2021-02-09 pain in extremity Arm pain, light headedness, nausea, fatigue
40 2021-02-09 tingling, cold extremities my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; fel... Read more
my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; felt like my heart pounding and racing/ fast heart rate; feeling too sick; started to feel flu like; muscle pain; fatigue; The initial report was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration in the left arm on 15Jan2021 09:15 AM at a single dose to prevent COVID-19. Medical history included known allergies: latex. Concomitant medications in two weeks included ergocalciferol (VIT D) and cyanocobalamin (VIT B12). The patient did not have any other vaccine in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular route of administration in the left arm on 26Dec2020 10:30 AM. She also previously took NYQUIL and experienced known allergies. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. The patient stated "I started to feel flu like around 7pm on January 15th. I had extreme muscle pain and fatigue. I woke up at 2am with what felt like my heart pounding and racing. The fast heart rate lasted about an hour. For the next +5 days, I had extreme fatigue, taking 3 hour naps at a time and still suffering from muscle pain. I attempted to go to work a couple of those days but went home half way through my shift because I was feeling too sick. Friday morning, 22Jan, I woke up feeling like I had leg weakness but I was still able to do activity normally. Saturday morning, 23Jan, I woke up with tingling to my hands and feet. I even had trouble typing at work. I made it through my shift this day with waves of muscle pain, fatigue and constant tingling to my hands and feet. Today Sunday, 24Jan I still have hand & feet tingling and my feet feel so cold like ice. I still feel 'off' overall. I plan do see my PCP this week to discuss these new symptoms in my hands and feet." The patient did not receive treatment for the events. She was not tested for COVID post vaccination. The outcome of 'heart pounding and racing/ fast heart rate' was recovered, and of remaining events was not recovered.
40 2021-02-10 weakness Started having nausea, dizziness, head ache, weakness and fatigue and chills lasted for 3 days. As t... Read more
Started having nausea, dizziness, head ache, weakness and fatigue and chills lasted for 3 days. As these were new symptoms and were a week and a half out from the vaccine. Went and was tested for COVID-19 and received a negative test. Missed 3 days of work. No one else in my house hold had any symptoms. No one else in the house hold has been vaccinated.
40 2021-02-10 feeling hot Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is ... Read more
Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Feb2021 at 03:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and dextropropoxyphene napsilate/paracetamol (DARVOCET); both from unknown dates to unknown dates for unknown indications and experienced allergy. On 02Feb2021 at 15:45, the patient experienced swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot; all reported as serious of being life-threatening. The events required a visit to the urgent care (physician's office). The patient was treated with epinephrine (EPIPEN) and unspecified medications at the urgent care after emergency medical services were called. The clinical outcomes of swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
40 2021-02-10 muscle spasms Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after ... Read more
Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after vaccine. Began to feel moderate body aches all over body with a headache. Began using restroom repeatedly with significant back pain and spasms. Muscle aches and pain continue. This reaction is after the 1st dose and I have had Covid July 2020.
40 2021-02-10 muscle spasms Headache, large muscle pain and cramping, and fatigue
40 2021-02-10 pain in extremity Pain in arm; This is a spontaneous report from a contactable other health care professional (patient... Read more
Pain in arm; This is a spontaneous report from a contactable other health care professional (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el9261 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 25Jan2021 15:00 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. On 26Jan2021 04:00, the patient experienced pain in arm. The patient did not received treatment for then event. The outcome of the event was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medication was taken within 2 weeks of vaccination.
40 2021-02-11 weakness Extreme fatigue, dizzy, weakness
40 2021-02-11 pain in extremity After 5 days, I have had pain in my right arm to my chest and the same pain from my right arm to my ... Read more
After 5 days, I have had pain in my right arm to my chest and the same pain from my right arm to my back. This pain does subside when I take Advil but then will return later that day. I have now had this pain for almost 3 weeks.
40 2021-02-11 cold extremities Systemic: Other- cold finger tips, raised bloodpressure; lasted 1 day
40 2021-02-11 throat numbness About 5 min after receiving the injection, throat and tongue began feeling numb and tongue felt thic... Read more
About 5 min after receiving the injection, throat and tongue began feeling numb and tongue felt thick. 30 minutes after injection, sudden need for BM. Oral, liquid Benadryl taken. BP 120/96, HR 93, SpO2 96%.
40 2021-02-12 tingling I began having heart palpitations on 2/8/2021 which I recieved an ekg for which indicated I have a s... Read more
I began having heart palpitations on 2/8/2021 which I recieved an ekg for which indicated I have a sinus arrhythmia - I have also had parasthesia in my R hand starting 2/13/2021.
40 2021-02-13 feeling hot Swelling of hands and fingers. Forearms radshy. Face was red, swollen and rash, looked like I had a ... Read more
Swelling of hands and fingers. Forearms radshy. Face was red, swollen and rash, looked like I had a sunburn I was so red. I was very hot.
40 2021-02-13 nerve pain Swollen deltoid, nerve pain down left arm and up neck area, sore left hip
40 2021-02-14 pain in extremity red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the w... Read more
red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient
40 2021-02-15 nerve pain, pain in extremity Weakness and Pain in muscles and nerves in legs. Swollen lymph node in right arm pit.
40 2021-02-16 weakness 4 hours after the 2nd dose I started coughing and feeling a little achy. about 8 hours later I start... Read more
4 hours after the 2nd dose I started coughing and feeling a little achy. about 8 hours later I started getting chills and major aches and pains. By 12 hours after I had the worst headache of my life along with major chills and awful body aches. The chills and aches were so back I couldn't sleep through them and was up most of the night bundled up under 4 blankets shivering and achy. I felt so dehydrated and drank water all night long. Every time I'd try to stand up out of bed I felt like I was going to throw up. About 24 hours after the shot the symptoms started to ease and I was able to stand and move again. Just been completely drained of all energy and have had no appetite since (at about the 30 hour mark).
40 2021-02-16 facial paralysis, numbness mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her ... Read more
mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears; headache; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper left arm on 01Feb2021 at 04:30 PM at single dose for COVID-19 immunization. Medical history included asthma (exercise induced) and menstruating. Concomitant medications included Ibuprofen because she was menstruating. No other vaccine in four weeks. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper right arm on 11Jan2021 at 04:30 PM at single dose for COVID-19 immunization. The patient was not pregnant. The skin of the patient's jaw and chin started to feel numb about 20 minutes after receiving the vaccine, headache came and went rapidly on 01Feb2021 17: 00. The sensation progressed rapidly to include numbness of her cheeks, eyebrows, and ears. The symptoms appeared rapidly after leaving the clinic as the patient was driving away on her from work. Both sides of her face were impacted equally. She went to an urgent care facility to be evaluated. An Urgent Care Physician's Assistant evaluated the patient. They looked inside her throat to see if it was closing up (it wasn't). They used a swab to test her sensory ability on her face by pressing with either the fuzzy-side or the blunt (wooden) side. When the patient asked the PA how she did, she indicated that she failed the test. They gave her Benadryl. At home, the patient went to bed, woke up normally, and did a "frown test" in front of the mirror. Her left side of face wasn't working the same way as the right side. She may have a mild case of Bell's Palsy in the morning of 02Feb2021. The patient had no covid prior vaccination, no covid tested post vaccination. Benadryl was received as treatment for the events. Outcome of the event "skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears" and "mild case of Bell's Palsy" was recovering, of the event "headache" was recovered.
40 2021-02-16 feeling cold, tremor, numbness Approx 10 minutes post vaccine patient reported she felt a c " cold rush" through her whole body, fe... Read more
Approx 10 minutes post vaccine patient reported she felt a c " cold rush" through her whole body, felt like she was shaking, developed hand tremors and then bilateral feet and calf numbness
40 2021-02-16 pain in extremity Headache, nausea, vomiting, sore arm, temp 102.8, chills began 1/08/2021 @ 9pm and lasted for 24 hou... Read more
Headache, nausea, vomiting, sore arm, temp 102.8, chills began 1/08/2021 @ 9pm and lasted for 24 hours The next menstrual cycle was very heavy period, soaking heavy flow tampons every hour, large clots, and lasted 6 days from a typical mild flow 3 day period
40 2021-02-16 tremor Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of brea... Read more
Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of breath. Within 30 minutes she had nausea, emesis and a strange feeling in her mouth/throat. Patient was monitored and did not require EpiPen. She was given Benadryl. She was recommended to not have a second injection due to immediate allergic reaction. She did
40 2021-02-17 numbness, pain in extremity, tingling severe right extremity pain, radiating down right arm; with rt arm weakness, numbness and tingling; ... Read more
severe right extremity pain, radiating down right arm; with rt arm weakness, numbness and tingling; with rt arm weakness, numbness and tingling; with rt arm weakness, numbness and tingling; brachial plexus neuritis / parsonage turner syndrome; brachial plexus neuritis / parsonage turner syndrome; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number=EK5730), via an unspecified route of administration on 18Dec2020 09:30 at single dose for COVID-19 immunisation. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history was none. The patient has no allergies to medications, food, or other products. The patient did not receive concomitant medications. On 30Dec2020 at 03:00 AM the patient experienced onset of severe right extremity pain, radiating down right arm, with rt arm weakness, numbness and tingling, after extensive workup determined to have brachial plexus neuritis / parsonage turner syndrome treated with steroids still recovering would not consider have had total recovery. The events were reported as non serious and resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with steroids. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has been tested for COVID-19 (PCR Nasal Swab, negative on 24Jan2021).
40 2021-02-17 pain in extremity, tenderness Weakness in arm 12+ hours post injection; instant arm soreness, tenderness and stiffness; extreme ar... Read more
Weakness in arm 12+ hours post injection; instant arm soreness, tenderness and stiffness; extreme arm soreness 12+ hours post injection; Mild sense of dizziness 2+ hours post injection
40 2021-02-17 pain in extremity I received the vaccine on 01/06/2021 and had some arm pain. On 01/07/2021, I had flank pain, a mil... Read more
I received the vaccine on 01/06/2021 and had some arm pain. On 01/07/2021, I had flank pain, a mild headache. Then on Friday night I had chest pain right underneath the right breast that would at times radiate into the neck. My pain continued all day Saturday and into Sunday morning, I went saw a Pulmonogist. After testing, it was determined it was not cardiac and that it was muscular. On 01/11/2021, I saw my Chiropractor that made an adjustment in my back. I also was a massage therapist. After seeing both, the symptoms eventually subsided.
40 2021-02-17 tingling My lips and skin on face surrounding lips and tongue got tingly, I took benadryl and it went away.
40 2021-02-17 tingling approx. 10 min post vaccine pt started to have elevated heart rate, dizziness, tingling in hands and... Read more
approx. 10 min post vaccine pt started to have elevated heart rate, dizziness, tingling in hands and feeling like her throat was "tight" and more difficult to swallow
40 2021-02-17 tenderness had second dose of COVID vaccine on 1/8/2021, notes initially with rash and swelling of face which w... Read more
had second dose of COVID vaccine on 1/8/2021, notes initially with rash and swelling of face which went away when she got home. Since then, patient has had HA but noticed swelling to left shoulder on 1/9/21. neck: 3 cm x 3 cm left supraclavicular lymphadenopathy with tenderness to palpation give ibuprofen 600mg PO x1 and discharged with Ibuprofen
40 2021-02-18 flushing Chest flush with bilateral arm flush EMS evaluated. Stayed 10 minutes longer and flush started to re... Read more
Chest flush with bilateral arm flush EMS evaluated. Stayed 10 minutes longer and flush started to resolve. Went home.
40 2021-02-18 muscle spasms, muscle twitching 24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain... Read more
24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain along with the feeling of my heart racing. Swelling lasted 9 hrs, self medicated with Zyrtec (Benadryl makes my heart race) . Tylenol 1000mg every 4 hrs for headache pain. Headache is still present daily. Switched to 800 Motrin every 6 hrs. Headache and lower extremity muscle pain, as well as nerve twitches and cramping still occurring 8 days post vaccine.
40 2021-02-18 nerve pain Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into lar... Read more
Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into large welts a few hours later that then turned into 2 large welts on the side/back of my upper thighs. 2 days later and ever since I have severe nerve pain that is constant and is affecting my ADLs.
40 2021-02-19 impaired body coordination, inability to speak, slurring Symptoms started with blurred vision within 30 minutes had full double vision , dysarthria and aph... Read more
Symptoms started with blurred vision within 30 minutes had full double vision , dysarthria and aphasia . Went to sleep, woke up 1 hour later bc I felt like I couldn?t breath. My arms and legs were very heavy felt close to paralyzed. I was able to move but movement was very ataxic and labored. Next morning the limb heaviness was gone, double vision was gone but had blurry vision for approx three days. Still having word finding difficulty, but mild.
40 2021-02-19 flushing Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiet... Read more
Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiety and hypertension. Initial BP 161/102 (pulse 102); final BP 132/88 (pulse 95). Benadryl PO given.
40 2021-02-20 pain in extremity, tingling I received dose #2 of the COVID vaccine on 2/11/21 and experienced mild arm soreness (lasting appro... Read more
I received dose #2 of the COVID vaccine on 2/11/21 and experienced mild arm soreness (lasting approximately 36 hours) and slight tingling to my entire arm on side of injection, down to fingertip (lasting approximately 24 hours). I took Motrin 400 mg the morning of the vaccine, once at bedtime on the same day, and once in the morning of 2/12/21. On 2/13/21 through 2/16/21, I felt great with no symptoms at all. On 2/17/21, almost a week after my vaccine, I woke up feeling dizzy, nauseated, and started having signifcant chills/sweats. Other symptoms included lethargy, headache, and loss of appetite. Per my employer's current protocol, I took a COVID test on 2/18/21 that was negative. On Friday, 2/19/21, my fevers were higher (101 degrees) and not responding well to over the counter Motrin. I was evaluated by a nurse practitioner in urgent care. Another COVID test was done that was negative. I was also tested for Influenza A and B, both negative. Otitis media, migraine headache, sinusitis, and strep were also ruled out. Hearts and lungs were normal and not concerning. My fever and above noted symptoms continued until the morning of 2/21/21, after which fever had subsided. Likely due to dehydration, fatigue and headache remains present but manageable and improving with rest and fluids.
40 2021-02-21 facial pain, facial paralysis After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 da... Read more
After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection. Currently still symptomatic.
40 2021-02-21 tingling, weakness, numbness A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went sti... Read more
A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move.  This lasted about an hour (15 hrs post-vaccine).
40 2021-02-21 tingling malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to ... Read more
malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to focus, and fatigue - day 3-6 chills- day 7 tingling in legs and feet/hands - day 4 and continue off an off for past 2.5 weeks after vaccine headaches- continued off and off for past 2.5 weeks
40 2021-02-22 facial paralysis swelling on the left side of my face; Bell's palsy/ left side can not function properly. I have litt... Read more
swelling on the left side of my face; Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982), via an unspecified route of administration (at the age of 40-years-old) on 26Jan2021 10:15 at a single dose in Left arm for COVID-19 immunization. Medical history was not applicable (N/A). The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced swelling on the left side of my face and Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement on 05Feb2021 10:30. The patient reported, "I have swelling on the left side of my face as well as Bell's palsy. My left side cannot function properly. I have little eye, mouth and forehead movement." The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The outcome of the events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Therapeutic measures were taken as a result of the events which included anti-viral medication and a steroid. The events were assessed as serious (Seriousness criteria-Disabling/Incapacitating). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
40 2021-02-22 pain in extremity, muscle twitching Two days after the dose in my right arm, I had a nerve or a muscle that was twitching that lasted fo... Read more
Two days after the dose in my right arm, I had a nerve or a muscle that was twitching that lasted for the three weeks until I got my second dose in my left arm. The left arm just had a normal aching for 24 hours. My right arm has rapid twitches like once or twice a day.
40 2021-02-22 speech disorder, breast pain Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminoph... Read more
Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.
40 2021-02-22 tremor Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (pat... Read more
Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea
40 2021-02-23 numbness, tingling Tingly face, minor numbness in left arm (injection side) maybe mouth and tongue numbness too
40 2021-02-23 muscle spasms Left hand felt sluggish almost like cramping, duration about 7 days or more.
40 2021-02-23 pain in extremity, electric shock sensation I noticed about 2:15 (15 minutes after injection)my elbow (funny bone) was very sensitive. Then the... Read more
I noticed about 2:15 (15 minutes after injection)my elbow (funny bone) was very sensitive. Then the pain went up my arm, over my left shoulder blade, up the left side of my neck, and up into the left side of my chest. It has lasted and seemed to be more intense more than 24 hours after. 1:00pm the next day, I got extremely light headed and dizzy, sat down and it went away after a couple of minutes. Called my Primary Dr. and was told to report it. I will be seeing a Dr tomorrow the 25th. The pain, I thought was maybe a hit nerve from the injection, its kind of like an electronical zap
40 2021-02-23 pain in extremity, nerve pain Insomnia, nerve pain in ears and legs, headache, fatigue after the insomnia, chills.
40 2021-02-23 seizure Patient had witnessed seizure like activity for 30 seconds. Patient transported to ER on Gurney with... Read more
Patient had witnessed seizure like activity for 30 seconds. Patient transported to ER on Gurney with RN All extremities contracted with grunting Airway maintained After activity was alert pale diaphoretic
40 2021-02-24 feeling hot, flushing Client complained of warmth and dizziness after receiving first Pfizer Covid-19 vaccine. Client was ... Read more
Client complained of warmth and dizziness after receiving first Pfizer Covid-19 vaccine. Client was sitting in post vaccine waiting area approximately 10 minutes before alerting EMT she was not feeling well. EMT alerted lead PHN to assist. Client alert and oriented, faced appeared slightly flushed, PHN asked client to lower mask to assess for any swelling or hives. Client denied shortness of breath, chest pain, allergies to vaccines in the past. Client stated room feeling warm. First set of vitals at 1020: blood pressure 124/80, pulse 79, respirations 16. Client was moved to chair near exit door for breeze of air and given water. Client walked with steady gait by herself. Shortly after being closer to open doorway client stated warmth feeling was improving. Per client only allergic to gluten products, only medication she takes is for thyroid and she had taken that this morning. Client asked if she could eat her snack she had in her purse, per client no breakfast this morning. PHN just instructed client to take small sips of water and eat slowly. PHN informed client her wait time would be extended to 30 min observation to make sure symptoms had improved prior to her leaving and client agreed. EMT stayed with client and reassessed vitals after 5 minutes. Blood pressure: 128/80, pulse 75, o2 98, skin color normal, alert and oriented, and client stated symptoms resolving. PHN and EMT reassessed client at 10:40, as client was approaching 30 minute observation. Vitals: blood pressure, 128/78, pulse 78, o2 99. Alert and oriented, client stated prior complaints had resolved. PHN had patient stand up by chair to assess for dizziness and client denied at this time. ER precautions given. EMT walked client out of building at 10:45, client walked out with steady gait.
40 2021-02-24 throat numbness 40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat ,... Read more
40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat , followed by generalized pruritus and the sensation of "throat tightening." Received epi from medical team but initially refused ER visit. Symptoms resolved but returned 15 mins later with numbness of the lips and throat, sensation of throat closing being additonal symptoms. She was agreeable to transport after the second episode.
40 2021-02-25 tingling, numbness, muscle twitching Paresthesias, on lower extremities and tingling on right arm all day; intermittent numbness; right e... Read more
Paresthesias, on lower extremities and tingling on right arm all day; intermittent numbness; right eye twitching daily; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received the second dose of BNT162B2 (lot number: EG686), intramuscularly in left arm on 12Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took tramadol and experienced drug allergy, and the first dose of BNT162B2 (lot number: GK5730) in left arm for COVID-19 immunisation. The patient experienced parethesias, on lower extremities and tingling on right arm all day, intermittent numbness, right eye twitching daily on 15Jan2021. The patient underwent lab tests and procedures which included nasal swab, COVID test result: Negative on an unspecified date. AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for these events. Patient was not recovered.
40 2021-02-28 weakness Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, ... Read more
Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.
40 2021-02-28 burning sensation, discomfort Persistent swollen lymph nodes in neck region. Persistent pain, discomfort, burning sensation in lef... Read more
Persistent swollen lymph nodes in neck region. Persistent pain, discomfort, burning sensation in left arm and neck region
40 2021-02-28 discomfort About 12 hours after the vaccine, I experienced a 102 degree temperature, all over body aches with t... Read more
About 12 hours after the vaccine, I experienced a 102 degree temperature, all over body aches with the most discomfort in my lower back, knees, and hips, headache and general fatigue. The next day all the symptoms went away except residual arthritic joint pain. The pain is more extreme during sleep and in the morning. My left knee has been swollen as well. There is a general feeling of whole body arthritis and is lessened by NSAIDs.
40 2021-02-28 feeling hot felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood press... Read more
felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood pressure as 132/90; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247 and expiration date not provided), intramuscular in the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included asthma and Seasonal Allergies. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), fexofenadine hydrochloride (ALLEGRA), and budesonide, formoterol fumarate (SIMBICORT TURBUHALER). After receiving the vaccine on 27Jan2021 09:30, the patient walked to the waiting room, sat down and felt a little dizzy, then felt a wave of heat from her head to her feet and her heart rate elevated. This lasted for the first ~5 minutes immediately receiving the vaccine, then completely subsided. From the firefighter's report: blood pressure as 132/90 and pulse of 76. Treatment was not provided in response to the events. The outcome of the events was recovered on 27Jan2021.
40 2021-02-28 numbness, tingling Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throug... Read more
Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throughout my body My chest, arms and legs felt heavy. It wasn?t hard to breathe exactly, but it just felt like it was hard to actually do it. If that makes sense Then, the scary one. My brain and my mouth were saying two different things. I became really pale (per medic) and I had a hard time figuring out how to say no. My mind just wouldn?t work correctly. And when I tried to speak, it was very confusing and I was told I wasn?t making sense by the medic. Then as quickly as it started, it stopped. Periodically through out the day today, I have gotten more confused than normal about simple things. Earlier I tried to say chicken. I said potato. I was thinking chicken but my stupid mouth said something different. The medic compared my symptoms to a stroke. Which was terrifying
40 2021-02-28 pain in extremity Sore arm, prolonged headache (possibly from the migraine I had the day I got the vaccine) Pregnant;... Read more
Sore arm, prolonged headache (possibly from the migraine I had the day I got the vaccine) Pregnant; due date June 16 2021. First pregnancy at the age of 40.
40 2021-02-28 pain in extremity After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting head... Read more
After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration in the right arm, on 06Jan2021 at a single dose, for Covid-19 immunization. Patient had no relevant medical history and no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility type where vaccine was administered was reported as other . On an unspecified date in Jan2021, after the first vaccine the patient had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination. Information about batch/lot number has been requested.
40 2021-02-28 pain in extremity arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contact... Read more
arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contactable other HCP. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 26Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history was not reported. there were no known allergies.Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose ofbnt162b2 on 06Jan2021 in right arm and experienced arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. After the 2nd vaccine, the patient experienced arm pain, fever, chills, headache, muscle aches and nausea on an unspecified date. there outcome of the events was recovering. There was no treatment for the events. The patient was not tested for COVID-19 prior and after the vaccination. Information on the lot/batch number has been requested.
40 2021-02-28 pain in extremity felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Fri... Read more
felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; dizziness; chills; headache; weird hallucinations; sore arm; felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, second dose) intramuscular in left arm on 28Jan2021 at 09:15 (at the age of 40-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Past drug history included allergies: cefazolin sodium (ANCEF). Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on 05Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had a sore arm and felt groggy on Thursday night (28Jan2021). The patient was feverish (highest temp was 100.4 F) with dizziness and chills and headache all day Friday, on 29Jan2021. On Friday night (29Jan2021) the patient had weird hallucinations (I hallucinated?, I guess, I was awake and talking to my husband and he said I seemed awake? but that my bed was breaking in half and sinking into the floor, and I kept telling him I couldn't breathe but he said I was breathing normally). No treatment was provided for the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache. The outcome of the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache was recovered on 31Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The reported event hallucination was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-02-28 pain in extremity Sore arm. Pregnant; due date June 16, 2021. First time mom at the age of 40. First pregnancy.
40 2021-02-28 tingling Dizziness and tingling
40 2021-02-28 throat numbness About an hour after vaccination, my throat was tingling and my heart rate went up. It came down afte... Read more
About an hour after vaccination, my throat was tingling and my heart rate went up. It came down after a bit and my throat/tongue felt slightly numb until I took a Benadryl.
40 2021-03-01 tremor Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath,... Read more
Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath, rapid heart beat, flush feeling, intense shaking (especially in legs), pain in chest, lightheadedness, dizziness (ruled anxiety) and was monitored for 40 minutes. Was given orange juice and water and allowed to remove mask to catch breath. Almost everyday since this event, the same event keeps repeating it self (almost daily for 3 weeks). I am unable to control these episodes. Emergency department (ED) has been called and I have gone to see my nurse practitioner. Been trying to make an appointment with my doctor for this week. I have lost 5 pounds (down to 105 lbs. so I can't afford to loose more weight) since this first happened and I have also lost my appetite and unable to function normally.
40 2021-03-02 discomfort, tingling Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in lef... Read more
Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in left arm, and person felt slight lightheadedness during observation. As person arose from chair, tingling in left arm began to increase and she asked healthcare worker if the tingling was normal. Worker stated "I think so". Friend then aided person as she began to fall to floor - person then placed on stretcher and became unconscious. EMTs times two were summoned to stretcher and they placed heart monitor and blood pressure cuff on person. Person was transferred to the Health Center - upon transfer, person became conscious and felt a heaviness on left side of body. Able to ambulate to BR and felt heaviness of left side of body. Bloodwork and CT scan were performed at FCHC and person reported as normal. It was decided by ER Doctor to transfer person to Hosp. Blood was drawn every so often and MRI was performed which person stated was all normal. Hosp. staff kept person overnight for observation. At approximately 2000 on 2/27/2021, person states that she felt back to normal with tingling of left arm subsided. Person was released early afternoon on Sunday, February 28th, 2021 after Doctor assessed person.
40 2021-03-02 numbness, tingling 10 minutes after getting her first COVID-19 vaccine, patient experienced L sided numbness and tingli... Read more
10 minutes after getting her first COVID-19 vaccine, patient experienced L sided numbness and tingling of her face, 5 minutes later this was followed by a globus sensation. Patient had CN 2-12 grossly intact and 5/5 muscle strength of the upper extremity. She had a patent airway without stidor. She was able to swallow liquids. Due to her history of angioedema, she was evaluated by EMS and sent to ED for further evaluation.
40 2021-03-02 migraine chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue seve... Read more
chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue severe enough to prevent normal activity; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), intramuscularly into the left arm on 28Jan2021 14:15 at a single dose for COVID-19 immunisation. Medical history included Polycystic ovarian syndrome (PCOS), depression, obesity and allergies to latex. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN), colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B12). The patient previously took tetracycline and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly into the right arm on 06Jan2021 03:15 PM at a single dose for COVID-19 immunisation. On 28Jan2021 20:00, patient experienced chills, fatigue, migraine-like headaches, dizziness, nausea and migraine-like headache and fatigue severe enough to prevent normal activity. The events were reported as non-serious. The patient did not receive any treatment for the events reported. Outcome of events was unknown.
40 2021-03-02 tingling, numbness Pt stated that about 10 minutes after receiving vaccine she felt like she was "hit in the back of th... Read more
Pt stated that about 10 minutes after receiving vaccine she felt like she was "hit in the back of the head", and had developed a severe headache. Pt also c/o numbness and tingling on the L side of her face. Checked for signs of a stroke, none noted. Vitals- B/P- 148/90; P- 108; R-14; SpO2- 94-96% on RA. Lung sounds clear. Pt denies any itching, difficulty breathing, or chest heaviness. No rash noted. Pt called her PMD who told her to have her husband bring her over to his office for evaluation. PHN called pt on 3/3/21 to check on status. States she still has a headache and some numbness on her face. States she is also having trouble finding words when she is talking. Encouraged to f/u with PMD again today.
40 2021-03-02 tingling, nerve pain, numbness Once injected, I felt a Swooshing in my brain, immediate numbness in my arm and fever in fifteen...n... Read more
Once injected, I felt a Swooshing in my brain, immediate numbness in my arm and fever in fifteen...nurse had me lay down for ten mins. Still felt weird and numb in arm, she said it was normal and sent me to leave. Tem mins into my car ride home my left cheek starting tingling and going numb. The nerves in my left leg began tingling all over. By the time I got to the hospital, I had similar symptoms of Temporary paralysis on left side yet my limbs were still functioning. When I left the hospital a few hours later, I was like 50 percent numb on my left side, all test results showed everything was good, blood, EKG and cat scan. I felt like I'd been injected with novacaine all over the left side of my body and I was in the stage where it is starting to wear down with tingling and itching on my hand leg and cheek on my left side. My back on left side and neck locked up. The numbing in my face took two weeks to decipate. While exercising never agitation occurred and felt like nerves were firing for two weeks. Severe ear nerve pain occured within first week. Followed up with personal doctor had mri of brain w/ and without contrast and that looked good. I am pretty healthy, maybe a few extra covid lbs. EKG good, CT scan good, blood work good. I am waiting to see neurologist for more testing. There is still random tingling in and out, very faint on left side of my body only. Use of my left hand feels
40 2021-03-03 weakness General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back o... Read more
General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back of throat
40 2021-03-03 difficulty speaking Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience t... Read more
Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience tongue swelling and her throat tightening. At 9:35 AM, Diphenhydramine 50mg IM Injection was given in the Right deltoid. Diphenhydramine lot number 6124005, EXP 04/22. At 9:48 AM, Patient continued to sound and feel throat raspy and coughing, patient was given an Epi pen into her right thigh. Epi pen lot number 0FM501, EXP 05/22. Patient was also given Solu-Medrol 40mg injection into the right glute at 10:30AM. Solu-Medrol lot number DP2618, EXP 01/22.
40 2021-03-03 migraine I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and th... Read more
I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and the next day my arm was very tender where I got the shot. The adverse side effect I'm most concerned about developed 2 days later. I noticed it hurt to turn my head and realized I had a lump on the right side of my neck sort of under my chin but a little to the right of that. It's making my throat hurt even though my throat itself is fine and the pain from this knot is radiating up to my right ear. I'm sure it's a swollen lymph node. I've had swollen lymph nodes before with strep throat but never have they hurt as much as this is and I've never had just one lymph node swell until now. I got the shot on a Saturday and this symptom began on Monday. I've been dealing with it for 3 days now, so if it's now gone in 2 more days I'll be going to my doctor for evaluation. I just wanted to report this and I was also wondering if this reaction has anything to do with the brain tumor surgery I had for an acoustic neuroma brain tumor and they put a metal plate in my head that my body had a bad reaction to causing hives, itching, and a lot of extra pain and irritation.
40 2021-03-03 pain in extremity Chills, sweats, fever 102.5+ for about 18 hours, body aches/pains (including bottoms of feet and pal... Read more
Chills, sweats, fever 102.5+ for about 18 hours, body aches/pains (including bottoms of feet and palms of hands), headaches, nausea.
40 2021-03-03 tingling 14:50 Client reported tingling sensation on L hand/ fingertips approximately 5 minutes after the va... Read more
14:50 Client reported tingling sensation on L hand/ fingertips approximately 5 minutes after the vaccine was received. No other symptoms presented. Client was A/O x 4, no respiratory distress observed. initial V/S BP 138/98, HR 81, RR18 and 02 sat of 97% on RA. 3:33, patient feels better and said she does not feel the tingling anymore. Instructed to call her PCP for further evaluation or call 911 for SOB or respiratory distress or any symptoms of anaphylactic reactions. Patient left the vaccination site without complaints
40 2021-03-04 feeling hot Pt reported feeling unusually hot and diaphoretic about 2 hours after receiving vaccine. Blood pres... Read more
Pt reported feeling unusually hot and diaphoretic about 2 hours after receiving vaccine. Blood pressure was running high with reports of 164/92, 169/102, 144/98 and then 135/89. Taken 10 minutes apart each time. Healthcare staff provided patient water and monitored during event. Began to feel normal again as bp went down. HR stayed between 69-79 during entire time.
40 2021-03-04 flushing After getting the shot, I walked over to the observation area a few yards away. I sat down and my vi... Read more
After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.
40 2021-03-04 pain in extremity, nerve pain Severe, continuous left arm pain that has been present since time of first injection. Limits arm mov... Read more
Severe, continuous left arm pain that has been present since time of first injection. Limits arm movement, weight-bearing ability and involves nerve pain. Have applied ice and heat, used suggested stretches & taken ibuprofen with no improvement.
40 2021-03-04 tingling At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating a... Read more
At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.
40 2021-03-05 flushing Fevers ranging from 99-103 daily for 3 weeks now, headache x 3 weeks, body aches, nauseous x 3 weeks... Read more
Fevers ranging from 99-103 daily for 3 weeks now, headache x 3 weeks, body aches, nauseous x 3 weeks, facial rash/flushing daily the past week 2 weeks from last dose. Severe fatigue unable to do my daily activities, missed work and sought care by pcp. Trying to see immunology at where vaccine was administered and Getting the run around by everyone.
40 2021-03-05 muscle spasms Initially, there was left sided neck and shoulder pain and severe headache which resolved after a fe... Read more
Initially, there was left sided neck and shoulder pain and severe headache which resolved after a few days. After approximately 1 week, a pinch was noted in cervical spine when turning head to the left. This quickly progressed to severe left sided muscle spasm in left neck and shoulder resulting in neck and shoulder pain and loss of range of motion in neck. At the time of this report, symptoms remain ongoing. Medications: Tylenol, Motrin, Aleve, Mobic, Toradol, Flexeril, Medrol. Muscle spasms are situation, pain has plateaued, range of motion slowly improving.
40 2021-03-05 seizure like phenomena, migraine, inability to speak 8 minutes after the administration of the vaccine (while in the observation area) I started to feel ... Read more
8 minutes after the administration of the vaccine (while in the observation area) I started to feel really off (dizzy, anxious, ringing in right ear). I ended up becoming unconscious with seizure like activity. They rushed me to the ER and kept me for 6 hours with lots of testing. XRay, blood test, CT of head, EKG, Urine test...all came back normal. Doctor said it was likely a reaction to the vaccine. I am 40 years old with no history of seizures or allergic reactions to vaccines. The week following I experienced confusion, migraines, dizziness, slow cognitive processing, eye strain, word finding difficulties, and exhaustion. I had to take a week off of work to recover. This is the second week and I am still experiencing headaches and occasional dizziness/eye strain.
40 2021-03-07 weakness Lightheaded following COVID -19 vaccine. Injection at 12:15 pm Vital Signs: B/P: 142/82 HR: 71 Resp.... Read more
Lightheaded following COVID -19 vaccine. Injection at 12:15 pm Vital Signs: B/P: 142/82 HR: 71 Resp.: 16 O2Sat: 95% Skin Signs: Warm and dry Circulation: Cap refill <2sec Resp.: Breath Sounds Clear Bilaterally Treatment: Pt assisted to cot. Requested to remain in sitting position. C/O dizziness and vertigo with head movements. Denies nausea , No flushing, skin p/w/d. Repeat Assessment: 12:45 pm Vitals: B/P: 132/82 HR: 74 Resp.: 16 O2Sat: 98% Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sounds bilaterally Treatment: Remains in seated position- Offered fluids- refused. Repeat Assessment: 13:02 pm Vital Signs: B/P: 122/88 HR: 73 Resp.: 16 Skin signs: Warn and dry Circulation: Cap refill <2sec Resp.: Breath Sounds clear bilaterally Treatment: Lightheaded, states "easier to focus eyes." No syncope, No increased light or vertigo with movement of head. 13:20 pm Pt released via wheelchair to vehicle to home with a friend. ALOx3, skin p/w/d. No further c/o dizziness . F/U Call: 2/4/2021 Fine after returning home. Woke up in the middle of night fell in BR x2 (no head injury) sweating, fevers, syncope, weakness, vertigo "spinning" disoriented felt delirious with 2nd fall in BR. Extremely nauseated.
40 2021-03-07 pain in extremity, weakness First dose on 02/14/2021 received 10:15 am. Symptoms started approximately 8 to 10 hours later. I ex... Read more
First dose on 02/14/2021 received 10:15 am. Symptoms started approximately 8 to 10 hours later. I experienced Brain fog, fatigue, weakness generalized malaise, headache, sore arm . No treatment, symptoms resolved after 4 days.
40 2021-03-07 pain in extremity, cold sweat my arm hurts; slight headache; cold sweat; This is a spontaneous report from a contactable consumer ... Read more
my arm hurts; slight headache; cold sweat; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: unknown), via an unspecified route of administration in the right arm on 26Jan2021 at 14:45 ( at the age of 40-year-old) as a single dose for COVID-19 immunisation at workplace clinic. Medical history included penicillin allergy (childhood). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. On 27Jan2021, at 12:00 the patient experienced my arm hurts, slight headache and cold sweat and did not last long at all (as reported). The patient did not receive any treatment for the events. The events were reported as non-serious. The outcome of the events my arm hurts, slight headache and cold sweat was recovered on an unknown date in Jan2021. Information on the lot/batch number has been requested.
40 2021-03-07 tingling Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pre... Read more
Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pressure on 2/17/21 and it was 212/116. I was having palpitations and parathesia in my right foot. I immediately contacted my provider and he confirmed my hypertension and I was prescribed two separate anti hypertensive medications. I began these medications however they have been ineffective at treating the high blood pressure. I began to have chest pains, headaches continued, and due to the hypertensive crisis I presented to the ER on 3/3/21 which required IVP BP medications, EKG, cardiac labs, etc. Prior to the COVID vaccination I have always had a normal blood pressure at all of my physical appointments.
40 2021-03-07 tingling Patient checked in for vaccine at 10:52am. During screening process, patient identified as needing a... Read more
Patient checked in for vaccine at 10:52am. During screening process, patient identified as needing additional monitoring (30 minutes) after vaccine administration. Patient received vaccine at approximately 11:00am, at which time she left vaccination site to observation site. Approximately 15 miniutes post vaccine administration, patient self-reported feeling of lightheadedness to RN at site. Doctor was informed and called over to assess patient, at which time he diverted patient to the 30 minute observation area and placed on Stryker bed.. During this period, patient continued to feel worsening of pre-syncopal type dizziness and developed parasthesias to bilateral arms and legs. VS at 11:35 am - BP 131/95; HR 82; RR 18; O2 sat 98%. Patient also endorsed some nausea, but did not vomit; negative abdominal pain. Patient did not present with any difficulty breathing, edema, urticaria, pruritis, or globus sensation. VS at 11:50am - BP 115/77; HR 72; RR 18; O2 sat 98%; patient seemed to be relatively comfortable. Clinically ,patient seemed to be improving, parasthesias resolving. Approximately 12:05pm, patient with complaint of increase dizziness, brief episode of chest pain, worsening parasthesias and exihibiting some difficulty breathing. VS at 12:07pm - BP 160/60; HR 90 12:10pm: EpiPen 0.3 mg adminstered to R thigh IM and 911 called. VS post Epi - BP 156/82; HR 151 EMS arrived at 12:15pm EMS started IV but had to wait for transfer due to social situation (2 children with patient). 12:39 pm, patient transported to Medical Center, with children, via EMS. Doctor spoke with ER physician. Patient was discharged at approximately 4:00pm after evaluated by ER physician.
40 2021-03-07 tingling Patient became nauseated, light headed, pre syncopal and with diffuse paresthesia. Given epinephrin... Read more
Patient became nauseated, light headed, pre syncopal and with diffuse paresthesia. Given epinephrine IM, sent to ED for eval
40 2021-03-07 tremor Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shak... Read more
Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shaking/tremors
40 2021-03-08 inability to speak Fast onset of Tiredness occurred at 11:00pm until 11:00am.. Sore arm at injection site lasted for 4... Read more
Fast onset of Tiredness occurred at 11:00pm until 11:00am.. Sore arm at injection site lasted for 4 days. Trouble breathing, felt like a weight on my chest and it was difficult to speak lasted for 90 minutes.
40 2021-03-09 weakness, numbness, flushing High blood pressure, tachycardia, difficulty breathing air, mental confusion, dizziness, nausea, as... Read more
High blood pressure, tachycardia, difficulty breathing air, mental confusion, dizziness, nausea, asthenia, numbness arms hands and legs, couldn't move arms, flushing facial on neck and arms, hyporexia.. applied hydrocortisone and medication to reduce blood pressure.. I was hospitalized for 3 hours and they sent me home.. reoccurance 12 hours later but with greater intensity and I was hospitalized again.. I am the patient and I am a medical doctor..
40 2021-03-09 breast pain The patient reports fever, chills, body aches, diarrhea, left axillary lymph node enlargement, and l... Read more
The patient reports fever, chills, body aches, diarrhea, left axillary lymph node enlargement, and left breast tenderness following first dose of Pfizer vaccine. Constitutional symptoms lasted less than 1 week and were managed conservatively. The left axillary lymph node and left breast remained painful and enlarged for approximately 1 month.
40 2021-03-09 flushing flushed, rapid heart rate. No throat swelling, shortness of breath, vomiting. NO signs of anaphy... Read more
flushed, rapid heart rate. No throat swelling, shortness of breath, vomiting. NO signs of anaphylaxis
40 2021-03-09 tingling Patient received first dose on 9 March 2021 at approximately 1430. Patient started to experience fac... Read more
Patient received first dose on 9 March 2021 at approximately 1430. Patient started to experience facial tingling, right arm tingling, shortly after approximately around 1430. 1445 tingling remained, member also started to complain of difficulty swallowing. Patient assessed by medical provider. Vitals and patient history obtained from patient. Member transported to TAMC at 1513.
40 2021-03-10 discomfort About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and start... Read more
About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and started getting uncomfortable. My throat then started to get dry and began breaking out with a rash on my neck and chest. This lasted about 30 minutes before the symptoms started to cease (in total 45 minutes after receiving the vaccine). Within 2 hours after receiving the vaccine, all symptoms had subsided. Treatment - at the vaccine clinic, EMTs observed me and took my vital signs. My blood pressure was slightly elevated, but did not require medical treatment. They continued to monitor me with the recommendation that I use my EPI-pen if symptoms got worse and instructed me to seek emergency medical treatment if symptoms got worse. No further treatment was sought out as symptoms all started to improve.
40 2021-03-10 flushing 10 days of symptoms and they continue -- aches, dizziness, decreased appetite, flushed, headache
40 2021-03-10 numbness, tingling I have been having intermittent paresthesias that began in my R thumb on 3/10 (day 4 s/p Pfizer #2) ... Read more
I have been having intermittent paresthesias that began in my R thumb on 3/10 (day 4 s/p Pfizer #2) around 4pm and by 9 pm this had spread to my first 3 fingers on my R hand. My thumb was completely numb. Woke up on 3/11 with no symptoms but by 11am my R thumb was numb again and this spread to my full hand/palm by 12pm, and then my L hand digits 1-3 and my L great toe and 2nd toe began tingling and felt numb. I started getting myalgias, L axillary pain but no palpable LAD, fatigue and a headache around 3pm and the paresthesias in my 3 extremities have recurred intermittently tonight. No pain or weakness in my extremities. Non-positional. No recent change in activities (I workout daily for an hour but no new exercises). I?ve never had any neurological issues with my extremities in the past. My only side effect after my Pfizer #1 on 2/14/2021 was just a few days of intermittent fatigue.
40 2021-03-10 numbness 20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then r... Read more
20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then resolved. Myalgias, fatigue and athralgias lasted a week and improved in 1 week in severity but intermittent athrlagias continue to occur. Over 1 month post 2 nd injection developed numbness of bilateral hands and feet and numbness of the mouth had recurred and is persistent for 6 days now.
40 2021-03-10 migraine Headache leading to migraine and vertigo
40 2021-03-11 muscle twitching, hypersensitivity of all senses Chills, fatigue, fever, extreme muscle aches, headache, loss of appetite, mild nausea, Extreme exha... Read more
Chills, fatigue, fever, extreme muscle aches, headache, loss of appetite, mild nausea, Extreme exhaustion, skin that's sensitive to the touch, bone aches, difficulty moving/walking/standing. Felt dehydrated. Started at 2:30am and didn?t go away until Sunday morning. Took Tylenol at 12 and 6pm, ibuprofen at 10pm. The following day my body hurt, headache, mild nausea. Still have pain in lymph node under vaccinated arm and arm muscle twitch. Mild dehydration.
40 2021-03-12 breast pain Severe sore breasts and menstrual abnormalities
40 2021-03-12 numbness Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I... Read more
Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I began feeling dissociated. Almost out of body, like I was under the influence. I began to struggle to answer questions and stay awake. I willed myself to stay calm and stay awake. I was given water and observed for an hour. My face began to feel numb and the roof of my mouth itchy. The ?high? feeling was eventually replaced by the feeling of being extremely tired. After and hour I was good to drive but extremely tired when I got home. About an hour after the shot I can taste a blood or metallic taste in my mouth. I still feel ?drugged? or tried.
40 2021-03-12 pain in extremity Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, ... Read more
Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, rash on face, extreme fatigue
40 2021-03-13 weakness FEELS LIKE BP IS HIGH, ELEVATED HR, WEAKNESSS. Evaluated by EMS- refusal to transport.
40 2021-03-13 burning sensation Felt fine after the shot. Woke up feeling fine the next day and then about 2 pm my tongue felt like ... Read more
Felt fine after the shot. Woke up feeling fine the next day and then about 2 pm my tongue felt like it was on fire and so did the fingers on my right arm. Now my whole body hurts and I feel like I?m going to throw up.
40 2021-03-14 burning sensation I have a diagnosed urinary tract infection a week after the first shot. I have a burning sensation a... Read more
I have a diagnosed urinary tract infection a week after the first shot. I have a burning sensation and frequent urination. I was tested and confirmed a UTI by my doctor.
40 2021-03-15 weakness Progress Notes Expand AllCollapse All Patient: ... Read more
Progress Notes Expand AllCollapse All Patient: DOB: 4/11/1980 Date: 3/16/2021 MRN: Subjective Patient is a 40 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience generalized weakness, "need for a quick snack". She denied rash, shortness of breath, difficulty swallowing or syncope This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to red flag findings ALLERGY REVIEW OF SYSTEMS Previous Reactions: none Objective Vitals Vitals: 03/16/21 0944 BP: (!) 158/103 Pulse: (!) 102 SpO2: 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is not ill-appearing or diaphoretic. Comments: Anxious on arrival to bay, "I think I just need a snack to feel better." HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Musculoskeletal: General: Normal range of motion. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert. Motor: No weakness. Psychiatric: Comments: Anxious affect Clinically, post injection anxiety related event. Elevated BP on arrival, improved with rest and granola bar. Salient anxious affect, post injection histamine response, requiring warm blanket, prolonged rest Ambulated with assist, additional snacks provided and pt discharged after 45" stay Assessment/Plan Treatment included: snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)
40 2021-03-15 pain in extremity After vaccine 1 on 02/04/2021 I only experienced a sore arm. After vaccine 2 on 02/26/2021 I exper... Read more
After vaccine 1 on 02/04/2021 I only experienced a sore arm. After vaccine 2 on 02/26/2021 I experienced soreness almost immediately. The next morning I had soreness at my ankles and knees. I also had extreme cold chills and a cough. I later experienced a fever of 101.8 degrees. Extreme tiredness.
40 2021-03-16 numbness patient complained of dizziness and leg numbness. PT was monitored for 45 minutes and then released ... Read more
patient complained of dizziness and leg numbness. PT was monitored for 45 minutes and then released when no longer complained of numbness or dizziness.
40 2021-03-16 muscle spasms, pain in extremity Felt tired but good Saturday afternoon. Sunday felt good, sore arm but thankful I didn?t get sick. M... Read more
Felt tired but good Saturday afternoon. Sunday felt good, sore arm but thankful I didn?t get sick. Monday morning 4am woke in pain in lower back. Felt Like a contraction. It was hard to rotate side to side, could not bend or twist. Stairs were very painful. Spasms in lower back would occur when back muscles were engaged, even lifting my arms or holding a cup of coffee caused strain and tension to my back. Wore salan pas patches to help with aches and at the end of the day, Took a muscle relaxer and went to bed early. Pain has subsided Tuesday. Still bending and twisting were tolerable and spasms lessen by 50%. Took motrin and slept. Wednesday walking is easier bending is better. Sit down to work and after 1/2 of not moving back began spasming.
40 2021-03-16 pain in extremity Red rash on chest. Got the same rash when I got Covid back in January. I feel very light headed and ... Read more
Red rash on chest. Got the same rash when I got Covid back in January. I feel very light headed and tired. Sore arm. Took 2 Tylenol. Nothing has helped .
40 2021-03-16 tingling, nerve pain Approx 8 hours after the Covid vaccine I began having tingling and nerve zaps in all limbs. These pa... Read more
Approx 8 hours after the Covid vaccine I began having tingling and nerve zaps in all limbs. These pains have continued since for the past 10 days and have not stopped.
40 2021-03-17 feeling jittery, tremor, weakness Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid... Read more
Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid vaccine with some feeling like throat and tongue were swelling but EMTs on the scene administered IV benadryl with the first dose. With doctor recommendation to receive the second dose about 20 minutes after she received the second dose she started feeling her tongue have a fuzzy swelling sensation and began coughing frequently around 11 a.m.. Patient took 50 mg of Benadryl of her own immediately before the vaccine in order to counteract the same reaction from the first one. Due to increasing symptoms she received Epinephrine 0.3 mg/0.3 ml one shot at 11:09 a.m. and a second shot at 11:17 a.m. Patient began to show signs of improvement from the Epipen but not enough with one shot so she proceeded with the second one. She was able to leave the vaccine clinic to see her general practitioner that afternoon. She expressed that she felt jittery after the shots and we determined that the Benadryl liquid she had with her and took had Phenylephrine in it as well which combined with the Epinephrine was causing the shakiness. She felt stabilized but weak. Her blood pressure was 140/100 at 11:50 a.m. and 137/88 at 11:55 a.m. Her allergist and general practitioner were contacted and notified of the incident and they instructed her further to use Benadryl tonight and to contact them tomorrow about any further concerns. She reported this evening at 5:27 p.m. that she was okay and did not have any further issues or the feelings of the allergic reaction.
40 2021-03-17 pain in extremity I received my second dose of the COVID vaccine on 3/5/21. The symptoms began on 3/7/21 with pain in ... Read more
I received my second dose of the COVID vaccine on 3/5/21. The symptoms began on 3/7/21 with pain in my upper left arm. The next following night, I was awakened by sharp pains from the top of my left arm to my fingers. Even the back of my left arm is swollen. It even traveled down my back. I went to urgent care on Sunday 3/9/21 to see what had happened. A CNP said it seems musculoskeletal and the pain radiated from the injection site. I've taken Tylenol, Ibuprofen, been prescribed muscle relaxers and steroids to numb the pain but it doesn't work. This is still occurring to this day.
40 2021-03-18 feeling cold 03/18/2021. 3:25pm. Strange tickle in throat and coughing but couldn?t really stop. Kept trying to d... Read more
03/18/2021. 3:25pm. Strange tickle in throat and coughing but couldn?t really stop. Kept trying to drink water. 03/19/2021. 3:00am. Woke in the night with a horrible headache, shivering and freezing. Took 2 Advil, bundled up and went back to bed. 03/19/2021. 7:00am. Woke with horrible headache that won?t go away, body aches all over, muscles feel weak and slight fever of 99.4 (my base is 97.7). These are all the same symptoms I had when I actually was positive for Covid 11/15/2020.
40 2021-03-18 numbness My face (cheeks) went numb. My tongue and throat started to tingle, like I was having an allergic ... Read more
My face (cheeks) went numb. My tongue and throat started to tingle, like I was having an allergic reaction. I had taken a Claritin for allergies before I received the injection. The numbness started approximately 30 minutes after receiving the injection. It last until I took additional allergy medicine three hours after the injection.
40 2021-03-18 numbness Patient is a 40 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 3... Read more
Patient is a 40 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/19/2021. The patient experienced the following reaction(s) during the immediate of observation: 12:07pm Patient c/o numbness to bilateral hands. Denies tingling, shortness or breathing, or difficulty breathing. Patient reports anxiety. Patient was treated/managed as follows: 12:09pm VS BP 150/82, HR 80, RR 18, O2 sat 98% on room air. States symptoms are subsiding. 12:20pm VS BP 154/84, HR 74, RR 18, O2 sat 99% on room air. Patient reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 12:28pm. Patient escorted to car by RN.
40 2021-03-18 pain in extremity I received the 2nd shot out of the Covid 19 series on Wednesday March 10th. I had severe left arm pa... Read more
I received the 2nd shot out of the Covid 19 series on Wednesday March 10th. I had severe left arm pain where I received the shot, could not even sleep on it and/or lift it. The following morning I woke up to go to work and throughout the day the symptoms progressed.it began with slight dizziness, headache, fatigue, nausea, chills and fever for the 24hrs following -- I ended up taking Tylenol Extra Strength for relief of the headache/fever. Exactly 6 days later I felt an itching on my wrist that later progressed to "Covid Arm" swelling at the site of injection, onto an upper body allergic reaction with hives then later to lower body as well. it has been relieved with Benadryl nightly.
40 2021-03-18 tingling Tingling sensation in arm and throughout body at least 24 hours after injection
40 2021-03-19 flushing Systemic: metallic taste in mouth -Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pati... Read more
Systemic: metallic taste in mouth -Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient states that she has metallic taste in her mouth post observation of 30 minutes -- patient states she still has it upon leaving
40 2021-03-19 hot flush Fever 101.7- 102.0, body aches, fatigue, joint pain, headache, chills, nausea, hot flashes, feeling ... Read more
Fever 101.7- 102.0, body aches, fatigue, joint pain, headache, chills, nausea, hot flashes, feeling all around unwell. I was so tired in the middle of the night I did not wake up when I was coughing and could not breath and was gasping for air. Because i was so fatigued I almost suffocated.
40 2021-03-19 migraine Headache - extreme pain/pressure, noon until nearly 6 pm when I took an Aleve, the pain then decreas... Read more
Headache - extreme pain/pressure, noon until nearly 6 pm when I took an Aleve, the pain then decreased to something like a regular migraine
40 2021-03-20 burning sensation, pain in extremity Burning chest pain, cough, sore throat, sweats, fever, shortness of breath, sore arm, achey
40 2021-03-20 numbness The day after the shot I had numbness in my right leg and foot. Three days after the shot I woke up ... Read more
The day after the shot I had numbness in my right leg and foot. Three days after the shot I woke up with the inability to taste. I can smell but no taste. ?Pfizer-BioNTech COVID-19 Vaccine EUA?
40 2021-03-20 pain in extremity Sore arm, stomach pain, nausea, diarrhea, bloating
40 2021-03-20 tingling body aches; prickly skin; Intense pain at injection site and in right shoulder traveling down to elb... Read more
body aches; prickly skin; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Chills; fatigue; general malaise; This is a spontaneous report from a contactable Other HCP, the patient. A 40-year-old non-pregnant female patient first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: UNKNOWN), via an unspecified route of administration, in the right arm on 03Feb2021 at 12:00 PM (at the age of 40-years-old) as a single dose for COVID-19 vaccination. Medical history included patient was diagnosed with COVID-19 (prior to vaccination). Since the vaccination, the patient had not been tested for COVID-19.The patient had no Known allergies. Concomitant medications included multivitamin and magnesium supplement. On 03Feb2021 at 16:00 the patient expereinced Intense pain at injection site and traveling down to elbow. Unable to raise arm overhead. Chills, body aches, fatigue, prickly skin, general malaise. No treatment was received for the events. Outcome of the events were recovered on an unspecified date. Information on the lot/batch number has been requested.
40 2021-03-20 tenderness Arm swelled and and has tenderness week after covid Pfizer vaccine
40 2021-03-21 flushing Moderate to severe joint pain in entire body ongoing. 19 hours since onset. Insomnia night of first ... Read more
Moderate to severe joint pain in entire body ongoing. 19 hours since onset. Insomnia night of first dose. Facial flushing and fatigue ongoing, 19 hours since onset.
40 2021-03-21 hot flush The Chief Complaint is: 40 y/o F with history of allergic rhinitis including systemic reaction to sk... Read more
The Chief Complaint is: 40 y/o F with history of allergic rhinitis including systemic reaction to skin testing years ago presents for COVID vaccination. She and I discussed getting vaccinated with her history a few weeks ago and I recommended vaccination. She reports that today she is in previous good health but 15 minutes after vaccination she started to feel itching all over her body which was rapidly followed by throat itching and difficulty swallowing. She was taken to the treatment area of the vaccination center and evaluated. - Pruritis, flushing, sclerae injection after COVID vaccination with PFizer vaccine. May be allergic or due to complement release. Treatment course - took patient back to the treatment area and administered 0.3mg epinephrine with rapid improvement in symptoms and signs and minimal side effects. Follow up BP lower, flushing improved, sclerae improved and throat symptoms improved. Called 911 for EMS response to observe her in the ED will complete VAERS and contact patient by phone for follow up
40 2021-03-21 pain in extremity Muscle and joint soreness in left shoulder and arm from base of neck to elbow; treated with 600 mg q... Read more
Muscle and joint soreness in left shoulder and arm from base of neck to elbow; treated with 600 mg qid. Resolved in 48 hours.
40 2021-03-21 tingling, numbness Felt numbing/tingling on and around lips. Lasted about 30 minutes then went away
40 2021-03-21 tingling Two days after the vaccine, my right foot started to feel weird - felt wet sometimes or felt tingly.... Read more
Two days after the vaccine, my right foot started to feel weird - felt wet sometimes or felt tingly. My foot was not swollen. I still have those weird sensations 18 days after getting the vaccine. Also, I had many small blood clots during my first menstruation after the vaccine (13 days after vaccine), which is not normal for me.
40 2021-03-22 weakness On the fourth day I began feeling a headache and weakness. On 5th day my symptoms increased to nause... Read more
On the fourth day I began feeling a headache and weakness. On 5th day my symptoms increased to nausea , vomiting, headache, dizziness, weakness, fatigue, diarrhea, trouble breathing, rapid heart beat. These symptoms persisted for a few days. Then came on again on March 21, 2021. I have visited urgent care center and have tested negative for covid. I have been prescribed pain for headaches and nausea. My symptoms continue and persist as of now. I have missed work due to reactions.
40 2021-03-22 numbness Numbness in left cheek, occasionally to left eye lid to upper left lip. Numbness comes and goes. C... Read more
Numbness in left cheek, occasionally to left eye lid to upper left lip. Numbness comes and goes. Currently still feel numbin face.
40 2021-03-22 tingling Pt presented to the medical tent with complaints of tingling in her tongue. States has long history ... Read more
Pt presented to the medical tent with complaints of tingling in her tongue. States has long history of allergies, has 2 epi pens with her and premedicated herself prior to coming to the vaccination site with 50 mg of PO benadryl at 1100. As pt was monitored she developed a rash on neck that was splotchy, flat, red. Tongue tingling stopped and moved to her fingers. BP was 152/90, other VS were WNL. Seen by MD on site. 1252 pt was feeling better, rash gone, all tingling gone. Pt left on own from vaccine site.
40 2021-03-22 tremor Within 10 minutes, I experienced tachycardia, hypertension, Sweating and shaking.
40 2021-03-23 pain in extremity, muscle spasms I don't know if it's related, but had severe pain in left arm, wrist, and middle& ring fingers. It ... Read more
I don't know if it's related, but had severe pain in left arm, wrist, and middle& ring fingers. It was like a severe cramp. I could not make a fist and lost most of my strength for about 4 days. I just woke up with the pain, I did nothing strenuous the night before. It is 80% but still hurts.
40 2021-03-23 pain in extremity First with left arm pain and unable to lift it; muscle aches Narrative:
40 2021-03-23 tingling Rush of tingling sensation and lightheadness. Symptoms resolved 10 mins later per pt
40 2021-03-23 tenderness After 12 days, I am still experiencing a lot of tenderness in my arm. It is slightly red and swollen... Read more
After 12 days, I am still experiencing a lot of tenderness in my arm. It is slightly red and swollen at the injection site and I have overall felt rundown for 12 days now.
40 2021-03-24 involuntary muscle movements, numbness, muscle twitching dizzy; feeling drugged; numbness; loss of most use in hands; took extreme amount of planning and eff... Read more
dizzy; feeling drugged; numbness; loss of most use in hands; took extreme amount of planning and effort to speak a singular word or move any part of body; nausea; vomitting; Hands/ fingers, legs, eye, all developed tics; Legs were twitching all night; little achey; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 40-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: UNKNOWN), via an unspecified route of administration in the left arm on 06Feb2021 at 16:30 PM (at the age of 40 years) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included bupropion hydrochloride (WELLBUTRIN), gabapentin, fluvoxamine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took cephalexine and experienced drug hypersensitivity. On 06Feb2021 at 17:30 PM, the patient started to get dizzy, feeling "drugged", numbness, then loss of most use in hands (significant weakness- could not hold a cup), took extreme amount of planning and effort to speak a singular word or move any part of body, nausea, vomiting, hands/ fingers, legs, eye, all developed tics, legs were twitching all night, little achy. No treatment was taken for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 18Feb2021, Nasal Swab: Negative. Information on the lot/batch number has been requested.
40 2021-03-24 involuntary muscle movements, seizure 2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It wa... Read more
2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It was like a seizure. I was unable to talk, my eyes rolled back, and my right shoulder and arm seized up. I was sputtering and unable to make it stop. Lasted for a minute or two then stopped for a minute and happened again. I felt disoriented, confused, scared. I was unable to walk straight or visually focus on anything. I contacted my primary care doctor and she recommended I be seen immediately but advised I call Providence and speak with a nurse. I did that and the nurse said to come in to the ER immediately. I did.
40 2021-03-24 difficulty speaking, weakness 03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve fo... Read more
03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid
40 2021-03-24 feeling hot, cold sweat Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self... Read more
Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self resolving symptoms with BP, pulse, O2 sat all within acceptable ranges with 60 minute observation No orthostasis and comfortable ambulation at discharge from observation unit
40 2021-03-24 migraine Symptoms: Migraine/Headache, nausea, vomiting, fatigue Treatment: bed rest
40 2021-03-24 migraine Migraine within 30 minutes of vaccine. I thought I was going to have to go to the hospital it was so... Read more
Migraine within 30 minutes of vaccine. I thought I was going to have to go to the hospital it was so bad. I had to work from home for a few days. I got tested by my neurologist (the Wed or Thursday following the vaccine -she prescribed a couple of new medications for me. the meds may have helped make the migraine more manageable but it was still there. It lasted 8 days. I generally get two or three a month and they last a day. This one would not go away. I was fine with the second dose on 2/5/2021 - I didn't get a migraine until after 10 days after second dose.
40 2021-03-24 pain in extremity Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At no... Read more
Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At noon I had severe pain the entire length of my right arm, and I felt drowsy so I fell asleep for several hours and the pain in my arm was moderate and restricted to injection sight when I woke up. I went to bed at 10 pm and woke up at 1 am with diarrhea. I spent the the next hour having a few diarrhea bowel movements. On 3/20 my right arm was still in moderate pain and injection site was swollen and red. At 8 am I woke up with a headache and so I went back to bed. By afternoon I had the chills and went to bed for another nap and when I woke up the chills were gone. On 3/21 my right arm still had moderate pain. On 3/22 I had another bout of diarrhea for one bowel movement, and my arm pain was still moderate. On 3/23 the swelling and redness at the injection site went away but the area is still slightly tender to the touch on 3/25. On 3/25 at 1 am I was in bed trying to sleep, but I kept having intense dizzy spells that lasted 3-4 hours.
40 2021-03-25 feeling hot, pain in extremity My first dose was 1/14. I found out I was pregnant on 1/26/21 and I miscarried at about 10 weeks. Ab... Read more
My first dose was 1/14. I found out I was pregnant on 1/26/21 and I miscarried at about 10 weeks. About 15 mins after I got the vaccine, I had a racing heartrate and my palms were hot, but it went away. Around 3pm, I had a right frontal headache. I took a nap and it went away. About 5am Fri, I woke up to severe arm pain and it felt like I was being stabbed in the stomach. I took about 400mg of Ibuprofen, went to sleep and was fine when I woke up. About 5pm Friday, I began having vaginal bleeding. I called my doctor and was able to get in on Feb 11th. At my OB/GYN appointment, they tested my blood and urine, which confirmed my pregnancy. The NP examined me and told me that the bleeding was coming from my cervix, so they sent me for an ultrasound the following week. That's when I was given my calculated date of 10 weeks. A gestational sac was observed, but they weren't sure if a fetus was present. I had to see my doctor every week since I was still bleeding and that continued until March 18th, when I lost the pregnancy completely. I took my specimen to the doctor the following day. They told me that they were sending it out to be tested, but I'm not sure if the results are back. They did confirm that it was a fetus.
40 2021-03-25 feeling hot Burning at tip of tongue without swelling and whole body feeling hot
40 2021-03-25 numbness B/P high, redness to face, Left arm numbness
40 2021-03-25 muscle twitching, tremor, seizure FiFive (5) seizures over the course of two (2) weeks. The seizures consisted of all of my muscles te... Read more
FiFive (5) seizures over the course of two (2) weeks. The seizures consisted of all of my muscles tensing up and my entire body twitching/ shaking for 1-2 minutes.
40 2021-03-25 myelitis transverse, tingling, numbness, sensory loss Loss of sensory waist down. Numbness and tingling waist down. Weakness in legs, heaviness in the le... Read more
Loss of sensory waist down. Numbness and tingling waist down. Weakness in legs, heaviness in the legs. Bladder and bowel problems - urinating frequently, urinary incontinence and constipation.
40 2021-03-25 pain in extremity Left arm pain , the next day after receiving the vaccine Pain is worse with movement
40 2021-03-25 tremor, hot flush Four hours after the first immunization had malaise, mild chills alternating with hot sweats. Treatm... Read more
Four hours after the first immunization had malaise, mild chills alternating with hot sweats. Treatment: 500 mg Tylenol x1 dose. After second immunization experienced severe chills with uncontrollable shivering/shaking and then profuse sweating and hot sweats for approximately 4 hours. Nausea followed the next morning along with an approximately 36-hour headache. Rested x2 days in bed. Treatment: Ibuprofen 800 mg alternating with acetaminophen 500 mg without relief x multiple doses.
40 2021-03-26 weakness After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fati... Read more
After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fatigue, intense muscle weakness & achiness, felt like weights in my veins. Sleep overnight was disrupted often. Intense strange dreams, perhaps lucid. 2nd Day- 9am: Fever & weakness subsided, muscles remained achy particularly with increased activity. Tiredness. 3pm: Fever returned. 5pm: Strong heart palpatations. Achy muscles. 8pm: Tiredness. Strange dreams, still lucid. 3rd Day- Still slight achiness. 3pm: Intense heart palpatations, pre-menstrual cramping (11 days early, my cycle is extremely regular). 5pm: Heart palpatations, muscles felt almost an electric pulsivity. 6pm: Tooth pain for about two hours. 8pm: Vaginal discharge (clear lubricant), lasted till 3am. 4am: Urine had extremely sour smell. *3rd day indicated to me that my hormones/hypothalamus may have been affected? Very strange, out-of-cycle behaviors. I have been sexually inactive for over 6 months.
40 2021-03-26 breast pain Very sore/tender breasts (both) and experienced what felt like a milk letdown sensation although I h... Read more
Very sore/tender breasts (both) and experienced what felt like a milk letdown sensation although I have not breastfed in over six years. Symptoms started the Saturday after the vaccination and have persisted since then. I have not yet been relieved of these symptoms but have not taken anything for relief.
40 2021-03-26 pain in extremity, hypersensitivity of all senses Moderate Diarrhea lasting ~4 hours, mild nausea, 102.7 fever, mild headache, sever joint & muscle pa... Read more
Moderate Diarrhea lasting ~4 hours, mild nausea, 102.7 fever, mild headache, sever joint & muscle pain, sever foot pain in sides of feet, severe sensitivity to touch, all beginning~11:00pm day of injection and subsiding ~24 hours later. With mild to Moderate joint pain persisting for an additional 24 hours. Moderate head pressure and Moderate dizziness starting upon waking up 3/27/2021, requiring setting medical attention with medication being prescribed, and symptoms have not eased at this time.
40 2021-03-26 pain in extremity Making my endmetrios worse. I have never been in this much pain on a period. It is also making my ... Read more
Making my endmetrios worse. I have never been in this much pain on a period. It is also making my bone pains worse and spreading it. They used to mainly happen in the arm and leg now it is everywhere.
40 2021-03-26 pain in extremity I started my period two days after receiving the shot, which was two weeks earlier than expected. Fl... Read more
I started my period two days after receiving the shot, which was two weeks earlier than expected. Flow was unusually heavy and very clotted - all abnormal for me. While I may have felt some fatigue from the shot, I never felt ill in any way. I also never felt any of the points of pain I might feel with my normal period, such as sore breasts prior to my period and cramps in my upper legs when it arrived. I only had a sore arm for a day where I received the shot.
40 2021-03-27 numbness Facial numbness, loss of taste. Also note- my VARS account is not accurate & you cannot adjust you a... Read more
Facial numbness, loss of taste. Also note- my VARS account is not accurate & you cannot adjust you answers- it has not been doing daily checks on me - it says I?m good when still having symptoms- there is not way to contact or correct info on that system.
40 2021-03-27 night sweats Last night I woke up with night sweats and all night went back and forth from night sweats to chills... Read more
Last night I woke up with night sweats and all night went back and forth from night sweats to chills. 101 fever and a terrible headache. Extreme fatigue.
40 2021-03-27 pain in extremity Complain of feeling dizzy, nauseous, numbness, pain in arms and legs bilaterally. no other symptoms,... Read more
Complain of feeling dizzy, nauseous, numbness, pain in arms and legs bilaterally. no other symptoms, 98% oxygen, pulse 71, no breakfast prior to vaccine, symptoms resolved. no EMS needed. observed for 30 minutes
40 2021-03-27 tingling nausea, tingling in left arm, waited additional 15 minutes, resolved
40 2021-03-28 migraine On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/202... Read more
On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/2021 Additional hearing muffled was was noticeable 3/16/2021: severe migraine, throwing up, nauseous 3/17/2021: facial rash prominent **hearing loss deemed permanent, ringing continuous
40 2021-03-28 night sweats starting nearly exactly 48 hours after vaccination: - fever: 99.5 - 101 (~48 hours) - chills (~48 ho... Read more
starting nearly exactly 48 hours after vaccination: - fever: 99.5 - 101 (~48 hours) - chills (~48 hours) - night sweats (~96 hours) - fatigue (~ 7 days) - muscle aches (~7 days) - headache (~7 days) - bloodshot & swollen eyes & blurred vision (started 5 days after vaccine, got Rx for bacterial eye infection 9 days after vaccine)
40 2021-03-28 tremor 13 hours after shot administered: 102 fever, severe shaking and chills, sweating, nausea. Throughout... Read more
13 hours after shot administered: 102 fever, severe shaking and chills, sweating, nausea. Throughout the next day: extreme fatigue, chills, fever, body aches, joint aches and swelling. 2 days after: overall body soreness, fatigue. All symptoms mimc that of the ones I had when sick with Covid.
40 2021-03-29 hot flush, feeling cold Waves of various symptoms onset about 4 hours post vaccine. Exhaustion, headache, lung pain, achy, h... Read more
Waves of various symptoms onset about 4 hours post vaccine. Exhaustion, headache, lung pain, achy, hot/cold flashes, arm pain?hot & not able to move it much
40 2021-03-29 pain in extremity Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). This no... Read more
Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247) intramuscularly in the left arm on 24Feb2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR DISKUS 250/50) and eletriptan hydrobromide (RELPAX 40 mg), both from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 on an unknown date for COVID-19 immunisation. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced sore arm. The event was reported as non-serious and did not require hospitalization. No treatment was provided for the event. The clinical outcome of sore arm was unknown. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
40 2021-03-29 seizure She was given her 2nd dose for the Pfizer covid vaccine. As she was waiting her allotted time in th... Read more
She was given her 2nd dose for the Pfizer covid vaccine. As she was waiting her allotted time in the waiting room she became lightheaded and felt like she might pass out. She became nauseated and was sweaty. A nurse was present getting her 2nd dose and helped to care for her until the fire dept came and took over. She lay on the ground with her feet up until the FD arrived. Listening to her interview by the fire dept, it was discovered that she normally suffers from epilepsy and probably had a small seizure. She wasn't able to remember everything but she was coherent and able to answer most other questions. Her blood pressure was elevated and slowly came down as they monitored her. Her boyfriend and son were also present and the fire dept released her to their care after seeing her blood pressure come down closer to normal and seeing her able to stand and walk.
40 2021-03-30 burning sensation, tingling, pain in extremity, feeling cold Sudden onset of severe pain in the right scapula about 2 days after the vaccine. Pain progressed to ... Read more
Sudden onset of severe pain in the right scapula about 2 days after the vaccine. Pain progressed to the shoulder, chest, biceps, triceps, forearm, and parts of hand. Sensations of burning, cold, and tingling are also present since.
40 2021-03-30 feeling jittery, tingling Lightheadedness, palpitations, sweating, Anxious/jittery, headache, Tingling-face. Patient was Tac... Read more
Lightheadedness, palpitations, sweating, Anxious/jittery, headache, Tingling-face. Patient was Tachycardic after the vaccination. 21540: pulse 139, 15:45: Pulse116, 15:50 Pulse 106, 15:55 pulse 100 O2 sat: 98 Patient placed on recumbent position, water given and was sent home at 1606.
40 2021-03-30 migraine Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; t... Read more
Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; throat ache; ear ache; unable to get out of bed for 3 days; extremely swollen lymph nodes; This is a spontaneous report from a contactable Other Health Professional, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:15 AM as a single dose for covid-19 immunisation. Medical history included allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (IBUPROFEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EJ1686) via an unspecified route of administration, in the left arm on 08Jan2021 at 10:00 AM as a single dose for covid-19 immunisation. On 30Jan2021 at 12:00 PM the patient exepereinced fever for over 3 days, going up to 103F, extremely swollen lymph nodes, severe migraines, dizziness, brain fog, loss of apetite, ear and throat ache, unable to get out of bed for 3 days. No treatment was given to the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.
40 2021-03-30 nerve pain, numbness Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree feve... Read more
Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree fever; lethargy; shivers; slept for 17 hours on and off; numbness in my face and fingers; numbness in my face and fingers; zinging pain in my teeth; This is a spontaneous report from a contactable Other HCP. This 40-year-old female Other HCP (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9267) via an unspecified route of administration from 11Feb2021 at 03:00 pm to 11Feb2021 at 03:00 pm at single dose (dose number; 2) on left arm for covid-19 immunisation. Vaccine facility type was reported other. Patient was 40 years old and not pregnant at the time of vaccination. Patient's medical history included Known allergies: Sulfa (unspecified dates). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9262) via an unspecified route of administration from 21Jan2021 at 3:30 pm to 21Jan2021 at 03:30 pm on left arm at single dose (dose number; 1) on left arm for covid-19 immunisation. Concomitant medications included (other medications in two weeks) Ibuprofen and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN-C) and birth control from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. If other vaccine in four weeks; no. On 12Feb2021 at 02:00 pm, patient experienced nerve pain in all of her skin (including hair follicles and teeth), extreme headache, 101 degree fever, lethargy, and shivers. This hit her at almost 24 hours after injection. She slept for 17 hours on and off. She awoke this morning with numbness in her face and fingers, but also zinging pain in my teeth. The reported adverse events did not result in emergency room or physician's office visit. Treatment received was reported as no for the adverse events. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of events was recovering.
40 2021-03-30 pain in extremity Headache; dizziness; sore arm; body aches; chills; This is a spontaneous report from a contactable c... Read more
Headache; dizziness; sore arm; body aches; chills; This is a spontaneous report from a contactable consumer (patient herself). A 40-year-old female patient received the second of bnt162b2 (formulation: solution for injection, lot number: EL9264), via an unspecified route of administration in left arm on 02Feb2021 at 14:00 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EL3302), in left arm on 12Jan2021 at 14:00 as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications received within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 14:00, the patient experienced headache, dizziness, sore arm, body aches and chills. The patient did not received treatment for the events. The outcome of the events was recovered.
40 2021-03-30 pain in extremity administration date=22Dec2020, dose number=1/administration date= 08Jan2021, dose number=2; arm so p... Read more
administration date=22Dec2020, dose number=1/administration date= 08Jan2021, dose number=2; arm so painful unable to stretch it out or to lift anything with that hand; arm so painful unable to stretch it out or to lift anything with that hand; This is a spontaneous report from a contactable other hcp. A 40-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EL3248, Expiration date: unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 08Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was administered the dose 1 on 22Dec2020 and dose 2 on 08Jan2021 (inappropriate schedule of product administration) with outcome of unknown). The patient has experienced severe pain where the patient is unable to stretch it out or to lift anything with that hand (pain in extremity) on 08Jan2021 with outcome of not recovered. No follow-up attempts are needed. No further information is expected.
40 2021-03-30 pain in extremity I did not know I was pregnant until the week after the vaccine; mild arm soreness; This is a spontan... Read more
I did not know I was pregnant until the week after the vaccine; mild arm soreness; This is a spontaneous report from a contactable other health care professional (reported for herself). A 40-year-old pregnant female patient received first dose of BNT162B2 (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EL3302) via an unspecified route of administration on 11Jan2021 at single dose to her left arm for Covid-19 immunization. The patient's medical history included polycystic ovarian syndrome (PCOS) and Covid-19 (prior to vaccination, the patient diagnosed with COVID-19). Patient's last menstrual period date was 01Dec2020, pregnancy due date was 13Sep2021 and gestation period when reaction/event was observed in the fetus was six weeks. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included metformin, minerals NOS/vitamins NOS (PRENATAL VITAMINS), curcuma longa (TURMERIC) and fish oil. Facility the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that, first dose had no issues, mild arm soreness, she did not know she was pregnant until the week after the vaccine in 2021. On advice of her OB that she could take TYLENOL for any possible fever side effects, she decided to take the second dose. Outcome of the event mild arm soreness was recovered on an unspecified date in 2021whereas other events was unknown.
40 2021-03-30 tingling, numbness to feel a tingling sensation on the outside of her arm through to her fingertips/mid-upper arm throu... Read more
to feel a tingling sensation on the outside of her arm through to her fingertips/mid-upper arm through thumb. The tingling was most noticeable, in her wrist and thumb; Her fingers felt like she had fallen asleep on her arm and the circulation had been cut off; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), via an unspecified route of administration, administered in arm left on 12Mar2021 14:30 as a single dose (at the age of 40-years-old) for covid-19 immunisation. The patient had no known allergies or other medical history. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The day after (13Mar2021 05:00), the patient began to feel a tingling sensation on the outside of her arm through to her fingertips. Her fingers felt like she had fallen asleep on her arm and the circulation had been cut off, it went away after a few hours and taking Advil. Day 2 (14Mar2021), the tingling was back, but on the inside of her arm, mid-upper arm through thumb. The tingling was most noticeable, in her wrist and thumb. The outcome of the events was not recovered.
40 2021-03-30 throat numbness Loss of feeling in throat.
40 2021-03-30 tremor Patient was shaking and had a high blood pressure. Vitals were normal upon arrival of paramedics, bu... Read more
Patient was shaking and had a high blood pressure. Vitals were normal upon arrival of paramedics, but was taken to the hospital for further observation.
40 2021-03-30 unresponsive to stimuli, migraine Anaphylaxis 40 y.o. female with multiple environmental allergies, migraines, asthma, mild OSA, and ... Read more
Anaphylaxis 40 y.o. female with multiple environmental allergies, migraines, asthma, mild OSA, and anxiety presents to the emergency department from the vaccine clinic with syncope and allergic reaction.She says shortly after getting her COVID-19 vaccine, she felt lightheaded, had near syncope. Per bystanders at the clinic, she had a brief episode of unresponsiveness and then spontaneously returned. She was conversant with multiple members of the code and rapid response team at the bedside. Did initially have some labored breathing but significantly improved. She had no vomiting but had mild nausea also significant improvement. In the field, IV was established and 125 mg of Solu-Medrol was administered. She was also given 1 IM dose of epinephrine. Her symptoms resolved she is at her baseline. Medically stable for discharge. Discharge home with short course of steroid, H2 blocker and Benadryl as needed. Advised patient to follow-up with PCP post discharge. Resume other home medicationS as listed. Of note, the patient had a similar reaction with influenza vaccine.
40 2021-03-31 feeling cold chills, body aches, lethargy. it lasted 12 hours, advil and naps helped
40 2021-03-31 feeling cold 12:20pm Headache, cold sensation in mouth/throat, pressure in chest. Patient appeared drowsy and c... Read more
12:20pm Headache, cold sensation in mouth/throat, pressure in chest. Patient appeared drowsy and complained of having difficulty staying awake. Vitals: 12:25pm 122/60 81 18 O2 97%; 12:33pm 139/70 85 18 O2 96%; 12:44pm 142/98 82 18 O2 97%; 12:48pm 143/90 82 18 O2 96%; 12:45pm 50 mg diphenhydramine given IM. 12:33 PM EMS called; 12:45pm EMS arrived; 12:50pm EMS departed to Hospital; Pt. was alert and oriented upon departure.
40 2021-03-31 feeling hot According to the patient, she experienced severe red and hot rash and hive all over her body. She ha... Read more
According to the patient, she experienced severe red and hot rash and hive all over her body. She had discomfort breathing and had to go to ER for treatment. She is currently taking loratadine and Benadryl to help treat the rash.
40 2021-03-31 flushing pt c/o wheezing, dyspnea, and flushing. She utilized her albuterol inhaler and took benadryl 50mg PO... Read more
pt c/o wheezing, dyspnea, and flushing. She utilized her albuterol inhaler and took benadryl 50mg PO and improved within 10 minutes or so.- pt with hx of asthma, seasonal allergies and eczema
40 2021-03-31 flushing Pt. developed severe red rash on face, neck, and chest within five minutes of vaccination noted by t... Read more
Pt. developed severe red rash on face, neck, and chest within five minutes of vaccination noted by two volunteer doctors on site at clinic. Pt. also c/o anxiety. Doctors on site administered Benadryl 25 mg po @1105. 1110: BP 153/98, Pulse 109, O2 sat 98%. Moved pt. to cot and continued to assess. No hives, itching, or swelling noted. 1120: BP 143/86, P 97. Pt.'s rash, flushing, and anxiety improved. 1130: BP 139/81, P 81. Pt. continued to improved and deny lightheadedness or SOB, left vaccination site @1150.
40 2021-03-31 hot flush Within minutes of my injection I had a hot flushing of heat fill and stay in my chest and throat. T... Read more
Within minutes of my injection I had a hot flushing of heat fill and stay in my chest and throat. The sensation was similar to receiving contrast dye for something like a CT scan. I was given Benadryl and my vitals were checked. I stayed at the clinic for a total of an hour. The sensation was fully gone about 90min after injection. I never felt short of breath or struggled to breath. I am experiencing pretty standard flu like symptoms within 12-24hrs after my second dose. Biggest and perhaps strangest side effect I feel now is all the lymph nodes in my right armpit are swollen and very sore.
40 2021-03-31 night sweats Developed fatigue within 5 hours. Developed severe full body aches, chills, night sweats, headache, ... Read more
Developed fatigue within 5 hours. Developed severe full body aches, chills, night sweats, headache, fatigue, restlessness, and sore muscles 11 hours after injection. As of 31 hours post-vaccination, side effects continue.
40 2021-03-31 tingling, burning sensation MILD back burning and tingling after 1st injection. After 2nd injection back burning and tingling b... Read more
MILD back burning and tingling after 1st injection. After 2nd injection back burning and tingling became SEVERE and tingling has now spread down both arms into hands and fingers and into chin and cheeks and lips. It seems to come and go and the longer I sit up the worse it gets. I am still very fatigue and joint discomfort. On 03/28/2021 I had to go to the ER because the pressure in my head and back became unbareable and I needed some relief. On 03/31/21 I had my Dr. see me and he was at a loss for words and said he was unsure on how to treat this. I ended up back in the ER on 03/31/2021 in the evening because the tingling in my back spread down to my finger tips and face and lips. and they too said they don't know how to treat this. CDC states 1258 people have reported PARESTHESIA symptoms.
40 2021-03-31 tingling Per Observation RN, patient had a complained of hand tingling and stated that she has history of Has... Read more
Per Observation RN, patient had a complained of hand tingling and stated that she has history of Hashimoto's disease and bilateral upper extremities tingling and anxiety Per RN, patient denied swallowing and shortness of breath. BP 111/79, HR 85,NKDA. per RN was given diphenhydramine 25 mg
40 2021-04-01 flushing Patient received Pfizer EW0150 by Nurse. Patient in observation area notified Nurse stated feeling o... Read more
Patient received Pfizer EW0150 by Nurse. Patient in observation area notified Nurse stated feeling of dizziness, flushness, numbness in tongue, throat itching and metallic taste. No audible wheezing, no shortness of breath, and no difficulty swallowing. (BP 153/99, HR, 77, Spo2: 98%) Patient with history of Asthma/Anaphylactic reactions. Allergies to Penicillin. Under observation, patient reports of improvement in condition, although still persistent throat itching and tongue numbness. 25mg Benadryl PO administered. HR: 83, BP:118/80, Spo2: 99%, patient further monitored and states feeling well with all symptoms completely resolve. Pt dc/ed educated on s/s to look out for. (HR 77, BP:112/70 O2:99%)
40 2021-04-01 numbness, tingling Numbness/tingling in left arm (from shoulder to hand) and left leg (from knee to foot)
40 2021-04-01 numbness She got her vaccine, and within the first 15 minutes felt like her tongue was fat. The reaction sta... Read more
She got her vaccine, and within the first 15 minutes felt like her tongue was fat. The reaction started at 1:15 and her headache was getting bad and turning into a migraine, and took her migraine medicine. She was getting a stretching and painful sensation in her skin over her head. She lost her ability to swallow, and everything around her face and neck were numb. She called the hotline and called her doctor, and was able to focus very hard and able to swallow but felt very narrow passageway. She then felt like she had a bubble in her throat, and then decided to call 9-1-1. The first responders came to her house and said that they could not see anything in her throat, they gave her Benadryl and within the hour everything seemed to dissipate and they stayed with her until she stabilized. Her BP was high and her heart rate was high as well, 98-100. Her temperature was 98.5. She felt really awful and nothing was going on with her throat or breathing after the Benadryl and felt foggy and tired and by the third day she was completely fine.
40 2021-04-01 muscle spasms 1/19/2021 vaccination. Felt flu like symptoms, body aches, feverish. I reported to every day on hea... Read more
1/19/2021 vaccination. Felt flu like symptoms, body aches, feverish. I reported to every day on health check-in. Muscle spasms, diarrhea, could not keep down water, HA, fatigue, lethargic. I thought I was dying. 1/21 0400am ER 1/22 ER 1/23 ER 1/24 ER; admitted inpatient to hospital. 11 Days inpatient. Nausea, vomiting, diarrhea, feverish, malaise, gastric spasms, HA, *12/2020 Gastrectomy *Symptoms lasted whole duration in hospital. Could not keep any liquids down.
40 2021-04-01 pain in extremity Very sore arm the morning after the shot, then developed a mild headache. Second day, headache is go... Read more
Very sore arm the morning after the shot, then developed a mild headache. Second day, headache is gone and arm is about 95% pain free.
40 2021-04-02 feeling hot WITHIN FEW MINUTES AFTER THE VACCINE, PATIENT FELT LIKE ELECTRICITY IN VEINS, HEAD FELT HOT LIKE B... Read more
WITHIN FEW MINUTES AFTER THE VACCINE, PATIENT FELT LIKE ELECTRICITY IN VEINS, HEAD FELT HOT LIKE BOILING, DIZZY, VERY HOT, FEELING LIKE VOMITING.
40 2021-04-02 migraine 9:40am injection. 10:30am migraine started. 10:40am strong ringing in my left ear, and feel dizzy. 1... Read more
9:40am injection. 10:30am migraine started. 10:40am strong ringing in my left ear, and feel dizzy. 11am spine, back, and joints hurt. Ringing in both ears, but I have lost partial hearing in my left ear. 10:22pm, still ringing in left ear, partial hearing, small headache, deep aches.
40 2021-04-02 nerve pain Generally occurring and resolving within 36 hours: Generalized neuropathic pain that turned graduall... Read more
Generally occurring and resolving within 36 hours: Generalized neuropathic pain that turned gradually into generalized nociceptive pain / soreness; Pounding headache at the base of the brain; Tachycardia; Sensation of pounding heartbeats; Nausea; Sensitivity to light; Loss of appetite and thirst; Low-grade fever Still occurring at 48-53 hours: Nausea Light headache; Sensitivity to light; Some sensation of heart racing; Localized pain in different areas of the body
40 2021-04-03 tingling, weakness On the drive home, I felt paresthesias in my left hand (pins and needles). This happened throughout ... Read more
On the drive home, I felt paresthesias in my left hand (pins and needles). This happened throughout the day several more times. The next few days it progressed to my dorsal forearm and elbow area, also becoming more intense and frequent. On Day 7 I noticed weakness of my left triceps. It became difficult to reach out and lift objects with that arm. I began ibuprofen on Day 8 and contacted my PCP. He advised me to continue Ibuprofen and give it more time. Weakness is not worsening. Frequency of paresthesias might be starting to improve, but still happens multiple times per day.
40 2021-04-04 feeling hot Pt received shot at 1145. At 1220, pt reported sx fo puffy eye lids (no puffiness visible outwardly)... Read more
Pt received shot at 1145. At 1220, pt reported sx fo puffy eye lids (no puffiness visible outwardly), ears ringing, blurry vision, feeling hot, weakness in muscles. VS: BP 126/68, P85, RR18, O2 99% RA, T98.6F. Pt takes benadryl 25mg po bid. Last dose 0400 today. Pt reports multiple previous hospitalizations for congestive heart failure, tachycardia, and bradycardia. She takes ?1500 of Levothyronine? and ?Mididrine four times a day to raise my blood pressure.? She does not want more benadryl at this time. She is calm outwardly. No signs of distress noted outwardly. Diminished lung sounds in bilat lower lobes. Pt smokes cigarettes. Dr consulted. Pt advised to wait in high risk obs for another 30 min to see if symptoms resolve. After about 5 minutes, pt requested EMS. No worsening conditions noted or reported. EMS called and came to assess pt. Pt left via EMS to go to hospital at approximately 12:15pm. Pt notified to follow up with her PCP prior to second dose of vaccine.
40 2021-04-04 muscle spasms Client reported that she felt a "Charlie horse" in the muscle near her wrist on left arm. Client sta... Read more
Client reported that she felt a "Charlie horse" in the muscle near her wrist on left arm. Client stated she felt "something " run down her arm when she rec'd her vaccine. Vital signs BP= 102/70 HR 81 R: 24: No complaint SOB or difficulty breathing. No visible injury to left arm or rash. Waited 75 6B 15 minute in parking lot.
40 2021-04-04 pain in extremity, weakness ON THE EVENING OF 3/30/2021 SHE DEVELOPED LETHARGY,BACK PAIN , HEADACHE, FEVER , CHILLS, ACUTE RIGH... Read more
ON THE EVENING OF 3/30/2021 SHE DEVELOPED LETHARGY,BACK PAIN , HEADACHE, FEVER , CHILLS, ACUTE RIGHT ARM PAIN AND LUMP ON SITE OF VACCINATION, WEAKNESS AND NAUSEA.
40 2021-04-04 tingling Dizziness, tingling and itchy skin, swelling and tingling of lips and tongue, slight throat swelling... Read more
Dizziness, tingling and itchy skin, swelling and tingling of lips and tongue, slight throat swelling. Treated at home with 50 mg Benadryl every 6 hours, Pepcid, and Predinsonl (steroid pack).
40 2021-04-04 seizure like phenomena 5 minutes after receiving COVID vaccine, the patient reportedly had a seizure like event. Patient w... Read more
5 minutes after receiving COVID vaccine, the patient reportedly had a seizure like event. Patient was monitored and rapid response was called. The patient was transferred to the ED where VS monitoring, EKG (normal sinus), and labs were collected. blood glucose was elevated, patient received fluids. Patient's glucose appropriately decreased following crystalloid administration the patient was feeling improved and no labs were of concern. Patient was discharged from the ED.
40 2021-04-04 tenderness Facial swelling at site of fillers Pain/tenderness in left armpit Pain/tenderness in left breast Hea... Read more
Facial swelling at site of fillers Pain/tenderness in left armpit Pain/tenderness in left breast Headache Neck pain
40 2021-04-05 weakness, seizure I received the injection on Wednesday, by Saturday I was feeling very sick. I had a fever of around ... Read more
I received the injection on Wednesday, by Saturday I was feeling very sick. I had a fever of around 102.5 on average and was feeling very weak. By Monday I was so weak I had to go to the doctor. In the dr. office I had a syncope event with tongue out, convulsions. Dr called 911 and was transported to the hospital via ambulance. The dr at the ER tested for Covid (negative) and stated this was a moderate adverse reaction to the vaccine. It took me a full 8 days to be able to not sleep all day and get some strength back.
40 2021-04-05 feeling hot patient reported feeling hot in the observation area and was brought to the EMS room H2O given allow... Read more
patient reported feeling hot in the observation area and was brought to the EMS room H2O given allowed to rest discharged in no distress @ 935.
40 2021-04-05 pain in extremity, tingling, numbness Site: Pain at Injection Site-Mild, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area... Read more
Site: Pain at Injection Site-Mild, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: arms and hands and at bedtime cant sleep due to pain and numbness
40 2021-04-05 tingling, numbness NUMBNESS AND TINGLING OF LEFT ARM, SHOULDER, FACE, AND TONGUE. NO SWELLING DIAPHORESIS, CHILLS, SO... Read more
NUMBNESS AND TINGLING OF LEFT ARM, SHOULDER, FACE, AND TONGUE. NO SWELLING DIAPHORESIS, CHILLS, SOME ITCHING AT 5:10 PM
40 2021-04-06 weakness dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, ... Read more
dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, chills the first night, pain and swelling in neck and spine only at night for 2 nights , very slight headache, slight fatigue and nausea and weakness after naps, then fine by day 3 then suddenly this morning I had slight chest pain (pressure) and severe vertigo and fell in the bathroom, bp normal, temperature normal, spo2 nornal, normal hr, i had no choice but to report to work or i would lose my job (teaching in private school)
40 2021-04-06 numbness Numb, swollen and tingling tongue and mouth (lasted for about a week) Headache, severe dizziness
40 2021-04-06 pain in extremity The next morning after I had arm pain and was very fatigued which lasted about a week. On 2/27 I s... Read more
The next morning after I had arm pain and was very fatigued which lasted about a week. On 2/27 I started experiencing on and off vaginal bleeding but drs had no treatment they could provide. I was diagnosed with a threathened miscarrage and on 3/22/2021 I miscarried. EDD-11/7/2021. There were several bouts of bloodwork perfomed which were normal until the miscarrage occurred and all ultrasounds were normal until the 3rd which showed the miscarriage.
40 2021-04-06 pain in extremity Fatigue Headache Swollen lymph nodes in right armpit Pain throughout arm down to fingertips
40 2021-04-06 tingling, burning sensation Tingling toes started around 12:50-1:00 pm Heavy feeling in chest about 20 minutes after injection ... Read more
Tingling toes started around 12:50-1:00 pm Heavy feeling in chest about 20 minutes after injection Heaviness in both arms within 30 mins after injection Pressure in chest next morning Burning, intense itching , hot inflammation around injection site next morning
40 2021-04-07 weakness Pt reported to post observation RN "I am feeling week, can you take my blood pressure?" Skin pwd. Pt... Read more
Pt reported to post observation RN "I am feeling week, can you take my blood pressure?" Skin pwd. Pt denied pain, dizziness, nausea, SOB. Pt denied any reaction with her 1st dose of Pfizer. No significant medical hx. RN called for aid and walked Pt through breathing exercises and gave her juice to drink. EMS arrived and VSS. Pt reported "different feeling in my chest, but now its better". After VS by EMS, Pt reported feeling " well and I know to contact a medical professional is I need more help later, yes". Pt ambulated independently with steady gait and family to check out.
40 2021-04-07 numbness I feel my left side of body especially my neck and shoulder and a little part of my jaw or cheek num... Read more
I feel my left side of body especially my neck and shoulder and a little part of my jaw or cheek numb. It is not that severe but still I feel it is not like my right side of the body.
40 2021-04-07 pain in extremity fatigue, sore arm, chills, dizziness fatigue and sore arm gone by Monday after the shot Dizziness in... Read more
fatigue, sore arm, chills, dizziness fatigue and sore arm gone by Monday after the shot Dizziness intensified and remains,
40 2021-04-08 burning sensation, feeling hot 2/9 vaccine #1 around 0930. Around 5pm notice neck was itchy, red and ?hot? feeling. Over the nex... Read more
2/9 vaccine #1 around 0930. Around 5pm notice neck was itchy, red and ?hot? feeling. Over the next few weeks the neck got a more widespread redness, the creases of my elbows became red and itchy then behind my knees became red and itchy. 2/23 I noticed the rash has spread to my truck and was starting to itch on my shins. Called dermatology clinic. 2/24 Derm appt #1- saw the NP. She thought it looked like a viral rash. Started oral steroids 60mg x3 days then tapered down over 10 day period. Ordered Triamcinolone cream for topical treatment and Zyrtec twice a day, 25mg hydroxyzine at night for sleep 3/2- vaccine #2 due... was told to hold off until the rash cleared just to make sure 3/7- itching and redness returned to neck and spread to truck. 3/9- Derm appt #2. Noted the rash had changed in appearance and biopsied arm. Received a steroid shot, Ordered pepcid twice a day, Allegra twice a day. 3/17- severe redness (the most extreme pic), burning and itching. It felt like a terrible sunburn with itchy hives under it. I can?t even begin to describe that pain. Called the Derm clinic. They ordered clobetasol ointment and go see Dr the next day. 3/18- biopsy with no eosinophils and only extreme inflammation. Received a loading dose (2 shots) of dupixent. 3/25- reddness and itching return to neck and shoulders/trunk. 3/26- Called Derm. Ordered a 40mg steroid taper that will last 20 days total. 4/1- Dupixent shot (2mL) 4/6- Appointment with Dr. Ordered Singulair and keep other taking medications. Lab work ordered.
40 2021-04-08 cold sweat patient has mitral insufficiency and vasovagal syncope. hit a vein and sight of blood and needle alm... Read more
patient has mitral insufficiency and vasovagal syncope. hit a vein and sight of blood and needle almost caused her to pass out. she was sitting on floor, very nauseous, blacking out, cold sweats, and palpitations.
40 2021-04-08 feeling hot 10 mins after injection, developed tingling in mouth and lips, tightening in throat, blotchy chest a... Read more
10 mins after injection, developed tingling in mouth and lips, tightening in throat, blotchy chest and neck. arrived to obs, 1830 bp 140/69 hr 95 rr 18 sats 96%, feeling hot. water and apple juice given, started feeling relief and blotchy neck and chest improving. 1838 bp 112/66 hr 97 rr 18 sats 95% on ra. 1847 bp 118/67 hr 67 rr 20 sats 99% on ra, blotchty areas resolved, and facial/mouth tingling resolved as well as throat tightness. escorted to exit with no further issues. instructed on benadryl once home.
40 2021-04-08 pain in extremity, tingling sore arm- lasted about 3 days redness, hot spot at injection site- developed within an hour and las... Read more
sore arm- lasted about 3 days redness, hot spot at injection site- developed within an hour and lasted 2.5 weeks hardness at injection site- developed within hours of being administered, still there at almost 3 weeks pain/tingling in arm developed within hours, lasted for a week headache- developed in both my husband and myself within an hour or so after injection, lasted until the next day massively aching joints- developed the next morning, lasted 3 days
40 2021-04-08 pain in extremity I am experiencing a lot of arm/shoulder pain a week after the shot. The pain was very acute right n... Read more
I am experiencing a lot of arm/shoulder pain a week after the shot. The pain was very acute right near the injection site the day after the shot, which I expected. But then I started to notice more pain in my upper arm, farther away from the injection site. A week later, I still have a lot of pain throughout my arm, between my shoulder and my elbow.
40 2021-04-08 pain in extremity Neck pain - moderate to severe Left arm pain - severe Headache - moderate Chest pain, left side - m... Read more
Neck pain - moderate to severe Left arm pain - severe Headache - moderate Chest pain, left side - moderate
40 2021-04-09 difficulty speaking 1/5/21: coughing, hoarse voice 1/6/21: increased anxiety, nausea, episode of dizziness, coughing, l... Read more
1/5/21: coughing, hoarse voice 1/6/21: increased anxiety, nausea, episode of dizziness, coughing, later in the day itching . Severe itching in the evening. 1/7/21: Redness on skin / hives, increased anxiety, tightness in throat, coughing - went to ER 1/8/21: Previous symptoms continued, along with tongue swelling. Went back to the ER. 1/9/21 + days symptoms continued.
40 2021-04-09 migraine Fatigue on-going. Retinal/occular migraine - left eye sight blurry, flashing, spinning zig zag light... Read more
Fatigue on-going. Retinal/occular migraine - left eye sight blurry, flashing, spinning zig zag lights without bad headache. Never experienced the vision issue before.
40 2021-04-09 muscle spasms Fever, chills, and general flu like symptoms for 48 hours For fist 24 hours, severe muscle cramps t... Read more
Fever, chills, and general flu like symptoms for 48 hours For fist 24 hours, severe muscle cramps throughout body
40 2021-04-09 muscle spasms 101 fever, muscle aches, fatigue, nausea, headache, occasional muscle spams, white coated tongue (on... Read more
101 fever, muscle aches, fatigue, nausea, headache, occasional muscle spams, white coated tongue (on day 2)
40 2021-04-09 tingling tingling sensation starting on my right feet, then right arm, then coming up on my body up to my fac... Read more
tingling sensation starting on my right feet, then right arm, then coming up on my body up to my face.; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN8730) via unspecified route of administration on 24Mar2021 12:45 PM at single dose for covid-19 immunization. The patients medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 on 03Mar2021 12:15 PM at left arm single dose for Covid-19 immunization (Lot number: EN6199). Within 10 minutes after the 2nd dose of the vaccine on 24Mar2021 at 01:00 PM patient felt tingling sensation starting on her right feet, then right arm, then coming up on my body up to my face. After 15 minutes of starting to feel those sensations, they stopped and I did not feel anything else so far it has been 8h approximately. No therapeutic measures were received for the event. The outcome of the event was recovered on 24Mar2021. Information on the suspect expiry date has been requested
40 2021-04-09 seizure Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head ... Read more
Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head and she had no control over it; Did not remember some of it; Confused; Unable to focus with her eyes; Extreme fatigue; Walking is unsteady; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 59267-1000-03), via an unspecified route of administration, administered in left arm on 24Mar2021 16:45 as single dose for COVID-19 immunization. Medical history included asthma, bronchitis, anxiety, allergy to Aspirin, NSAIDs, agave, soy, and dairy. The patient has no history of COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not COVID tested post vaccination. Concomitant medications included venlafaxine and progesterone taken for an unspecified indication. On 24Mar2021, 19:30, the patient experienced seizure like events. She began sputtering, her shoulder and neck seized up, eyes rolled back in her head and she had no control over it and did not remember some of it. It happened twice in a row. She had been confused, unable to focus with her eyes, extreme fatigue, and her walking was unsteady. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the events. The patient was requested for testing and referral for neurologist for MRI. The patient has not recovered from the events. Follow up attempts are possible. Further information is expected.
40 2021-04-10 breast pain muscle aches, total body soreness, tenderness at injection site, chills/low grade fever, armpit/brea... Read more
muscle aches, total body soreness, tenderness at injection site, chills/low grade fever, armpit/breast area soreness. Headache. Fatigue. Lasted over 24 hours without improvement. 4 days later - feeling almost better
40 2021-04-10 breast pain Lymph node swelling and tenderness in armpit, breast area - lasted about 5 days. Started about 5-7 d... Read more
Lymph node swelling and tenderness in armpit, breast area - lasted about 5 days. Started about 5-7 days after shot.
40 2021-04-10 feeling cold, tremor Adverse effects were Covid-19 like symptoms that consisted of; foggy brain, extreme thirst, chills, ... Read more
Adverse effects were Covid-19 like symptoms that consisted of; foggy brain, extreme thirst, chills, shakes, cold, fever, body aches, loss of taste and extreme exhaustion.
40 2021-04-10 muscle spasms Diarrhea, tired, some cramping, low fever, swollen throat, fast heart rate at times
40 2021-04-10 nerve pain Severe fatigue started 6 hrs after vaccine Aggregated my chronic nerve pain and made it worse New St... Read more
Severe fatigue started 6 hrs after vaccine Aggregated my chronic nerve pain and made it worse New Stabbing muscle and nerve pain throughout body New joint pain especially worse in knees and fingers Difficult to move body because of so much pain
40 2021-04-10 pain in extremity, muscle spasms I had mild upper left back ache for a few days before vaccination. However, I was still able to do m... Read more
I had mild upper left back ache for a few days before vaccination. However, I was still able to do my physical exercises even with the back ache and could sleep properly. The night after vaccination, I started to feel lethargic and tired and right arm (vaccination site) became heavy and painful which was expected. However, my upper left back pain magnified so much that I woke up at 2 am and could not find a comfortable posture to sleep in. Next morning, I tries hot pack, massage, ointment and lay down the whole day but the pain was there. I took Tylenol before going to bed the next night and woke up again around 2 am due to back pain which was coming in spasms or kind of radiating from neck to upper left back. I used hot pack again this morning. Pain seems mild now but not gone completely. Not sure if vaccine caused it or it was just a coincidence. After vaccination on Friday, I did not work out so don?t know how the back ache flared up. I have not been to a doctor but will go on Monday Apr 12 if it does not get better.
40 2021-04-11 breast pain Swollen lymph nodes under left arm, left breast pain and discomfort lasting 3 weeks ( still ongoing)... Read more
Swollen lymph nodes under left arm, left breast pain and discomfort lasting 3 weeks ( still ongoing). Swollen lymph nodes around neck.
40 2021-04-11 discomfort throat pain and chest tightness that began shortly after 2nd covid vaccine; sx started 5 minutes aft... Read more
throat pain and chest tightness that began shortly after 2nd covid vaccine; sx started 5 minutes after vaccine administered. Given 50mg of IM Benadryl in office but O2 sat was still 89%. Clinic called EMS to transport pt to ER. Upon arrival to ER, patient discovered she was pregnant. She presented with sore throat and feeling of pressure and palpitations but denied any chest pain, lightheadedness, etc to ER physician. Pt was released home.
40 2021-04-11 numbness, sensory loss I received my first Pfizer COVID vaccination on 3-1-2021. Seven days later I had a Shingles outbrea... Read more
I received my first Pfizer COVID vaccination on 3-1-2021. Seven days later I had a Shingles outbreak, which I've never had before. My doctor advised that I should continue to get the second vaccination as it's a two step process, which I did on 3-25-2021. I'm now experiencing numbness and loss of sensation that started in my foot and hand which has now progressed up my leg to my hip and from my hand up my arm. My doctor ordered a MRI scan which showed lesions on my spinal cord. Based on the results of the first MRI scan my doctor has ordered a second scan (showing more of the spinal cord) and a brain scan. She has also scheduled me an appointment to speak with a Neurologist to try to determine the cause of this. I can't help but feel that this vaccine was the cause of this as it all started shortly after I was given my first dose.
40 2021-04-11 migraine 4/8/21-Very stiff neck, pain level 8. Hard to move. Improved the following day. Did not take NSAIDS.... Read more
4/8/21-Very stiff neck, pain level 8. Hard to move. Improved the following day. Did not take NSAIDS. Developed constipation. Developed a migraine (to be expected) 4/10/21-developed "Covid Arm" rash. Raised red itchy rash. 4/11/21-rash grew to size of silver dollar, didn't respond to topical hydrocortisone, took benadryl. 4/12/21-rash has settled down some but is still present. Having continued issues with constipation (was not an issue until the vaccine). Period is late, not at risk for being pregnant.
40 2021-04-11 migraine Intractable migraine and nausea x 5 days Unrelieved by any medical therapy Finally aborted with st... Read more
Intractable migraine and nausea x 5 days Unrelieved by any medical therapy Finally aborted with steroid high dose pack for 14 days
40 2021-04-11 migraine Lethargy High fever Migraine Loss of taste Body aches
40 2021-04-11 night sweats, migraine fever between 104 and 99.9, body aches, chills, night sweats, migrains
40 2021-04-11 pain in extremity heavy/sore arm, fatigue, chills, body ache
40 2021-04-11 pain in extremity Nausea, vomiting, diarrhea, arm pain, tiredness. symptoms started 5 hours after injection and lasted... Read more
Nausea, vomiting, diarrhea, arm pain, tiredness. symptoms started 5 hours after injection and lasted 12 hours.
40 2021-04-11 seizure About 1.5 hours after second dose of Pfizer COVID-19 vaccine, patient was driving and experienced wh... Read more
About 1.5 hours after second dose of Pfizer COVID-19 vaccine, patient was driving and experienced what she believed was a seizure. She has a past medical history of seizures, but had not had one for over 15 years after being stable on Keppra. Patient did have a minor motor vehicle accident and went to ER. At ER, she returned to baseline and it was determined it was either a seizure or syncopal episode. She was instructed to follow-up with neurology.
40 2021-04-12 feeling hot, cold sweat Patient complained of a headache, nausea, clamminess, feeling warm and sweaty. Vitals stable. Laid p... Read more
Patient complained of a headache, nausea, clamminess, feeling warm and sweaty. Vitals stable. Laid patient down in Trendelenburg position. Symptoms improved, headache became less severe. Nausea returned when patient sat up. No symptoms of anaphylaxis.
40 2021-04-12 flushing Flushed face and chest pressure at 09:34. Patient brought her own childrens oral Benadryl and took 4... Read more
Flushed face and chest pressure at 09:34. Patient brought her own childrens oral Benadryl and took 40 mL as instructed by her doctor . At )9:53, patient stated her throat was getting tight and her tongue swelling so she received a epipen.
40 2021-04-12 tingling, numbness Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Slight tingling in t... Read more
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Slight tingling in the arm patient received the vaccine in. Patient waited 30 mins while I monitored. Once tingling subsided and she reported she was \"feeling fine\" she left.
40 2021-04-12 tremor, hot flush Within minutes of receiving the injection I experienced waves of dizziness to the point of almost pa... Read more
Within minutes of receiving the injection I experienced waves of dizziness to the point of almost passing out, rapid heartbeat, full body hot flashes, sweating, hand tremors,, dry mouth Observed for 30 min and released with no intervention. Waves of vertigo continued throughout the day, but are decreasing in frequency but not intensity as days go on. Within an hour of injection psoriasis on left leg flared and was raised, red and extremely itchy through Sunday, 4.11.21. Severe headache through end of day on 4.9.21. Treated allergic symptoms with 10ml Benadryl every 5 hours for 2 days, Ibuprofen PRN for pain. All symptoms subsided except for headache and dizziness/vertigo but appears to be decreasing in frequency but not intensity.
40 2021-04-13 breast pain After the second dose I got my usually very regular period 10 days early. I also had breast soreness... Read more
After the second dose I got my usually very regular period 10 days early. I also had breast soreness for about 3 weeks, starting a few days after the second dose. I think it is important for you to look into what about the vaccine could trigger women's periods to change.
40 2021-04-13 cold sweat Approximately 24 hours after receiving the Pfizer Covid vaccine, I experienced hot/cold chills, clam... Read more
Approximately 24 hours after receiving the Pfizer Covid vaccine, I experienced hot/cold chills, clammy face and lips. I noted that I had pink/red allergic marks on both legs. I mentioned it to the nurse today as I was receiving my 2nd dose and filled out report.
40 2021-04-13 discomfort I couldn't sleep the night of the day that I got the vaccine due to body aches and chills, and gener... Read more
I couldn't sleep the night of the day that I got the vaccine due to body aches and chills, and general feeling of discomfort. The next day I had a low fever that lasted the entire day, along with the body aches, chills, headache, nausea and soreness around the injection site -- basically, I felt flu-like. The fever didn't break until the following night around 1:30-2 a.m. -- so, 24 hours after symptoms started, and heading into the second day following my vaccination. I noticed the lymph nodes in both arm pits were painfully swollen, as well, which was not a side effect that I was warned about, so it freaked me out. The node in my left arm pit -- the arm where I got the vaccine -- was more swollen and painful than the right arm. And that swelling did not leave until three days after my vaccine. In short, I was feverish and ill the night I got the vaccine, and all of the following day after getting the vaccine. I still felt nauseated and had a headache two days after my vaccine -- which is when my lymph nodes in my under arms were also noticeably swollen and painful -- but the fever was gone. Three days out from the vaccine, the flu-like symptoms were gone, except for headache and fatigue. All told, I missed two days of work, and was "down for the count" feeling sick for three days.
40 2021-04-13 numbness, tingling tingling and numbness of the entire arm
40 2021-04-13 numbness Headache & Numbness in lips/nose within the 1st hour. I called to report symptoms and was advised t... Read more
Headache & Numbness in lips/nose within the 1st hour. I called to report symptoms and was advised to monitor and if gets worse to call back and go to ER. At this time I am ok and no need to go to ER as I am not having trouble breathing and no swelling.
40 2021-04-13 pain in extremity, sciatica, muscle spasms Lower back pain, joint pain, hip and upper thigh pain. ER visit 3/21/21. Sent home with pain reliev... Read more
Lower back pain, joint pain, hip and upper thigh pain. ER visit 3/21/21. Sent home with pain relievers and told it was a muscle spasm. Urgent care visit 04/09/21. Told it may be sciatica nerve. Advised to seek a chiropractor.
40 2021-04-13 tingling, numbness 2 of her fingers on left hand went numb/pins and needles sensation in left hand, sensation went to l... Read more
2 of her fingers on left hand went numb/pins and needles sensation in left hand, sensation went to left foot and toes in her left foot, right fingers, right toes/both arms and legs; Over time her Upper right back also felt the tingling sensation with pain; Upper right back felt tingling sensation with pain/pins and needles feeling varies in intensity and severity throughout her extremities and upper back; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 40-year-old female patient first dose received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL1283) intramuscular in upper left arm on 25Jan2021 at 16:25 at single dose to prevent covid/immunisation in hospital. Patient's Medical History was none. Concomitant medications were not reported. No events following prior vaccinations. No prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. The patient received the 1st dose on Monday 25Jan2021 and about 45 minutes after the injection, two of her fingers on her left hand went numb, they were probably numb for 20 minutes then receded. Then she experienced pins and needles sensation in her left hand, then the sensation went to her left foot and toes in her left foot. Within a couple of hours, that evening, her right fingers and right toes were feeling numb on and off. By the next morning in involved both arms and legs. She is still experiencing these feelings and it now involves her upper back. It is kind of like the pins and needles feeling moves. Right now she has it in her upper back, hands and feet on both sides. Over time her Upper right back also felt the tingling sensation with pain on25Jan2021. The sensation comes and goes and is still persistent until now. Earlier when she was standing, she felt it in her lower legs. When she was walking the pins and needles sensation increased a lot, she could feel it a lot of more when walking in her hands and feet. When she sat down it started to recede in her hand and feet but then the feeling started in her upper back. States it is transient, the pins and needles feeling varies in intensity and severity throughout her extremities and upper back, she has not been without the pins and needles feeling since it started. She is asking if she should get the second dose. Advised to consult with hcp. She is asking what to do since it spread to more areas. Her hcp told her she could not advise whether or not to get the second dose. She called the cdc and she was told she should probably not get the second dose since it sounds like an allergic reaction. She is asking if this sounds like an allergic reaction. She talked to her doctor and was told to try Benadryl (Lot: SNF001 Expiration date: May2022, UPC: 1254717136) and Zyrtec (Lot: 0HE2721A or OHE2721A Expiration: Mar2020), states neither one really helps, she clarifies that it helps for an hour or so and then her symptom comes back. States Zyrtec (clarifies it is a generic Target brand, allergy relief by up and up) is supposed to be for 24 hours but both zyrtex and Benadryl only helps for about 2 or 3 hours, they did not take the feeling away completely, just kind of reduced it. Patient did not visit to emergency room and physician office. Advised to consult with hcp. The outcome of evens was not recovered. Information on the lot/batch number has been requested.
40 2021-04-14 weakness Terrible body aches, extremely painful headache, chills, nausea, tiredness. Could not get out of bed... Read more
Terrible body aches, extremely painful headache, chills, nausea, tiredness. Could not get out of bed for 24 hours. Couldn?t eat more than a bite of a cracker drink fluids. Could not sleep because of headache. Started to feel better after approximately 24 hours, but still weak and tired and not feeling normal for several days after second vaccine.
40 2021-04-14 weakness My left leg is heavy , weak and tired feeling on certain day. I have days when I limp and can't make... Read more
My left leg is heavy , weak and tired feeling on certain day. I have days when I limp and can't make my left leg work. Within an average week, I might have one or two days where it doesn't impact me as bad.
40 2021-04-14 discomfort Patient is a 40 y.o. female who received the Pfizer lot # EW0158 on 4/15/2021. The patient experienc... Read more
Patient is a 40 y.o. female who received the Pfizer lot # EW0158 on 4/15/2021. The patient experienced the following reaction(s) during the immediate of observation: 2:25pm Patient vaccinated. 2:46pm Patient c/o left sided "throat tightness and heaviness." Patient was treated/managed as follows: Patient alert and verbal. Denies shortness of breath or difficulty breathing. VS BP 100/60, HR 70, RR 18, O2 sat 99% on room air. Patient reports arthritis to area and receiving PT two days ago. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 2:59pm O2 sat 99% on room air. Patient reports feeling better. Escorted to car by son and RN.
40 2021-04-14 feeling cold Immediately after vaccine pt began feeling lightheaded, shakey legs, chest tightness and warmth. Den... Read more
Immediately after vaccine pt began feeling lightheaded, shakey legs, chest tightness and warmth. Denies tunnel vision, hearing changes and shortness of breath. Pt transported to obs at 1743 via wc. Around 1749 pt states she feels cold, lightheaded when sitting up and persistent chest tightness. Pt declines call to EMS and EMS transportation. She does agree to drive herself to urgent care for further evaluation. Pt states she feels safe to drive. Pt released by self at 1803. Vitals as follows: 1744 BP 134/90 HR 64 SPO2 100; 1749 BP 135/78 HR 65 SPO2 100; 1756 BP 155/87 HR 74 SPO2 100
40 2021-04-14 flushing dizziness, nausea, flushed skin, mild urticaria to arms and back. headache as well sx onset less tha... Read more
dizziness, nausea, flushed skin, mild urticaria to arms and back. headache as well sx onset less than 5 min post vax EMS called and trasnported to ED no meds given on site no resp distres
40 2021-04-14 mild one side paralysis Left hemiparesis
40 2021-04-14 numbness, flushing, tingling, migraine 15-20 minutes post injection symptoms included tingling and numbness in the limbs, flushed face, rac... Read more
15-20 minutes post injection symptoms included tingling and numbness in the limbs, flushed face, racing heartbeat, fogginess, confusion, extreme fatigue, panic/anxiety. Symptoms increased in severity over the course of 9-10 hours and dissipated following sleep. Migraine headache followed at 24 hours post injection.
40 2021-04-14 numbness, tingling SYMPTOMS BEGAN 40-45 MIN. POST VACCINATION AFTER LEAVING FACILITY. CLIENT REPORTS NUMBNESS/TINGLING... Read more
SYMPTOMS BEGAN 40-45 MIN. POST VACCINATION AFTER LEAVING FACILITY. CLIENT REPORTS NUMBNESS/TINGLING BEGINNING IN LEFT ARM , PROGRESSING DOWN ENTIRE LEFT SIDE, UP RIGHT SIDE TO LEFT SIDE OF FACE AND HEAD, THEN DOWN RIGHT SIDE OF ENTIRE BODY , PROGRESS UP TRUNK. DIFFICULTY SWALLOWING DEVELOPED- "THROAT FELT SWOLLEN" NO DIFFICULTY BREATHING. NO HIVES OR OTHER RASH NOTED. NUMBNESS/TINGLING CONTINUES TODAY. THROAT SWELLING SLIGHTLY IMPROVED, CAN SWALLOW VERY SMALL BITES OF SOLIDS, AND LIQUIDS. LAST EVENING HAD CONTACTED PCP WHO ADVISED BENADRYL, WHICH SHE TOOK A DOSE 4/14/21 EVENING, AND AGAIN 4/15/2021 12:00PM. ONLY OTHER SYMPTONS VOICED IS MILD SITE TENDERNESS.
40 2021-04-14 numbness, trigeminal neuralgia Increase in symptoms of trigeminal neuralgia--pain/sensations/numbness, increased inability to sleep
40 2021-04-14 numbness Amphylactic shock Numb arm Breathing Throat swelling
40 2021-04-14 pain in extremity, numbness Severe leg pain (inability to stand for longer than a minute). Extreme fatigue. Facial numbness. Los... Read more
Severe leg pain (inability to stand for longer than a minute). Extreme fatigue. Facial numbness. Loss of taste.
40 2021-04-14 pain in extremity pain in left arm started approximately 6-8 hours after receiving the vaccine. The pain was much high... Read more
pain in left arm started approximately 6-8 hours after receiving the vaccine. The pain was much higher 24 hours later, and I found it difficult to move my arm in any direction. The pain was mainly muscular, involving movement. Only slight pain when touching the location where the shot was administered. The pain did not subside until at least 48 hours later. After 48 hours a new symptom began. I am now experiencing extreme fatigue. The fatigue continues today, so it has lasted at least 3 days. I am a runner and normally do not have this kind of heaviness. I have been unable to run since receiving the vaccine.
40 2021-04-15 feeling cold, sensory loss, weakness, numbness Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Tod... Read more
Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Today Three weeks later I experienced same icy sensation plus numbness/weakness, decreased sensation in fingertips. 2. Still have bad Headaches still after 3 weeks 3. Extreme Fatigue still after 3 weeks 4. Last few days, three weeks after shot, I have worsening/ Increased joint pain, spiky pain in joints, chills and entire body aches like I have the flu. No fever, no runny nose, etc. Just the body aches, joint pain like people experience with the flu. 5. Decreased mental sharpest last 2 weeks since shot. 6. Light headedness, dizziness. 7. Immediately after shot I experienced metal taste in my mouth. Since the shot, I still experience occurrences of metal taste every day. 8. Today experiencing slight numbness in right foot. 9. Swelling in fingers
40 2021-04-15 flushing Within 15 minutes after vaccination "flushed with noted erythema of face/ant chest with complaints o... Read more
Within 15 minutes after vaccination "flushed with noted erythema of face/ant chest with complaints of itchiness of face/chest, with tachypnea, wheezing and reported sensation of throat swelling w/ shortness of breath."
40 2021-04-15 migraine, weakness Migraine, fever weakness, tiredness , bad body pain
40 2021-04-15 pain in extremity, tingling Fever, chills, body aches, pain under right arm, tingling skin
40 2021-04-15 pain in extremity Site: Pain at Injection Site-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Detail... Read more
Site: Pain at Injection Site-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Pt said her arm was sore for two days and also her Left Eye Burned and felt like acid was in her eye for about 90 second time periods about 3 episodes a day for 2 days.
40 2021-04-15 pain in extremity Heavy-feeling limbs, muscle aches, sore feet, swollen gland in armpit
40 2021-04-15 pain in extremity I had flu like symptoms the first 48 hours with fogginess, tiredness, and achiness. The these sympto... Read more
I had flu like symptoms the first 48 hours with fogginess, tiredness, and achiness. The these symptoms seemed to get better after eating meals then got worse again off and on over the first 48 hours. When I woke up the day after the 2nd vaccine my left leg felt like it was going to give out walking on it almost like the feeling when you are pregnant and the muscles relax. This did not happen with the first dose. It lasted most of the day and part of the next eventually resolving with the right leg not showing that symptom at all. About 48 hours after the dose I experienced very painful lymph nodes. I'm breastfeeding and called my OB and described what felt like mastitis without red streaks or fever. My armpit, arm, and wrist ached. I have only experienced the wrist ache once with mastitis about 9 years ago. I'm currently taking sunflower lethicin and benadryl. Today is April 16th and I still have swollen lymph nodes and a sore arm and wrist.
40 2021-04-16 cold sweat, migraine Vomiting, migraine, chills, body aches, fever, clamminess
40 2021-04-16 numbness, nerve pain Started with chills and body aches on the 4th day. Pain level increased by midnight, unable to sleep... Read more
Started with chills and body aches on the 4th day. Pain level increased by midnight, unable to sleep. Took Ibuprofen. By the 5/6th day, severe pain, fatigue, no appetite, little nausea, and occasional low degree fever (99-101F) Alternated Ibuprofen and Acetaminophen every 5 hours. 8th day around 9pm, left arm went numb and tingling at the fingertips. 9th day, appetite is back and feels back to self.
40 2021-04-16 migraine The first 12 hours just a sore arm; approx 12 hours in and I had a severe migraine and nausea with v... Read more
The first 12 hours just a sore arm; approx 12 hours in and I had a severe migraine and nausea with vomiting. I haven?t sought medical treatment yet because it?s the weekend and nothing is open. Also body aches and chills and stomach cramps which are severe at times.
40 2021-04-16 muscle spasms Leg cramp at 545 am progressed to traveling muscle aches. By 11 am it felt like my hands and feet ha... Read more
Leg cramp at 545 am progressed to traveling muscle aches. By 11 am it felt like my hands and feet had developed arthritis. By 6 pm my muscles felt like stone and my joints hurt horribly and I was exhausted. Reached out to my doctor on Monday, switched to ibuprofen and rested. Finally started feeling less pain Tuesday am and by Wednesday am all muscle and joint pain was gone. Lethargy and fatigue still ongoing.
40 2021-04-16 numbness and pain in extremities Neuropathy in hands and up to elbow od left arm and both feet up to knees.
40 2021-04-16 pain in extremity Severe shoulder and arm pain initially. Arm pain subsided and shoulder pain still persists. Never ha... Read more
Severe shoulder and arm pain initially. Arm pain subsided and shoulder pain still persists. Never had shoulder pain prior to this vaccine.
40 2021-04-16 pain in extremity Asymptomatic until bedtime, 101.9 fever for 6 hours and currently 100.3, but it's fluctuating. Sever... Read more
Asymptomatic until bedtime, 101.9 fever for 6 hours and currently 100.3, but it's fluctuating. Severe shaking chills, and throbbing bone and joint pain. My perineum also oddly feels as though I've been kicked rather hard. Sleepless night until chills subsided. Then experienced mild nausea, and pain in both palms while hand washing. No congestion, but dry inflamed sinuses and eye pain. I developed a headache this morning, but only while standing.
40 2021-04-16 pain in extremity Low grade fever for 24 hrs, headache for 24 hr, left arm where the shot was given was sore for 48 hr... Read more
Low grade fever for 24 hrs, headache for 24 hr, left arm where the shot was given was sore for 48 hrs
40 2021-04-16 pain in extremity Arm soreness - started a few hours after the injection and lasted 2-3 days Fatigue, aches, chills - ... Read more
Arm soreness - started a few hours after the injection and lasted 2-3 days Fatigue, aches, chills - started about 12 hours after injection and lasted 2 days
40 2021-04-16 tremor, tingling Within 4 minutes of getting her second dose she complained of tingling from head to toe, feeling as ... Read more
Within 4 minutes of getting her second dose she complained of tingling from head to toe, feeling as if something was caught in her throat, chills and shaking
40 2021-04-17 slurring, pain in extremity tiredness; arm pain; muscle weakness; intoxication; slurred speech; equilibrium off; feeling of euph... Read more
tiredness; arm pain; muscle weakness; intoxication; slurred speech; equilibrium off; feeling of euphoria; minor light head/dizziness/giddiness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 09:30 as single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. 2 hours after shot (03Apr2021 11:30), minor light head/dizziness. 3 hours after shot (03Apr2021 12:30), slurred speech, equilibrium off, feeling of euphoria, giddiness, intoxication, overall felt amazing. 7 hours after shot (03Apr2021 16:30), tiredness, arm pain, muscle weakness. 24 hours after shot (04Apr2021 09:30) no arm pain, feeling normal, still feel a sense of euphoria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive ant list of any other medications within 2 weeks of vaccination. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no allergies to medications, food, or other products. There is no known allergies and other medical history. The outcome of the events was resolving.
40 2021-04-17 feeling hot, breast pain, weakness At approximately 6pm on 4/16/21, I began feeling as if I were in a fog (second dose of COVID-19 vacc... Read more
At approximately 6pm on 4/16/21, I began feeling as if I were in a fog (second dose of COVID-19 vaccine received at 10:30am previous day). I began to feel weak and tired; all I wanted to do was lay down. I laid in bed and took my temperature via ear. 100.8 in the right ear and a reading of 101.2 in the left ear (I've not had a fever since maybe 12 years of age). I was also experiencing a headache (back of head) and neck discomfort. I felt hot, specifically ears and face. I took 400mg of ibuprofen at approximately 7pm and 1000mg of acetaminophen at approximately 10pm. by 10:30 my temp was 98.9. I woke up at 1:30am on 4/17/21 and was completely drenched I sweat. I assumed this was from the fever break but I woke up again at approximately 4am drenched again. After waking and getting up around 8am on 4/17/21, I felt great; back to normal. I went about my day. I woke again around 1:30am on 4/18/21 with a sore neck and the back, lower area of the head hurting (this wasn't the same feeling as having a stiff neck or laying in an awkward position). When I sat up, I felt some sore, throbbing on the top of my head which then subsided. I woke again at 4:30am with the same issue. I was also, again, completely drenched in sweat but no fever this time that I am aware of. My pajamas were soaked. I felt some relief with the head and neck discomfort when I got up at 6;30am. As I type this now, my head and neck feel basically normal. I also wish to report that in addition to injection site soreness which I think is always to be expected, I have been experiencing quite a bit of soreness and discomfort under my left arm. It runs down my left side from my arm pit to the side of my left breast. This area has been sore and tender since the evening of the day I received the shot (4/15/21). I'm assuming this could be due to stolen lymph nodes which I was told by a health care professional, could be a side effect of the vaccine.
40 2021-04-17 numbness, tingling complaint of numbness and tingling 4th and 5th fingers of left hand, full ROM, normal strength, cap... Read more
complaint of numbness and tingling 4th and 5th fingers of left hand, full ROM, normal strength, cap refill <3 sec, BP- 124/68, O2 sat- 97% Examined by Dr, repeat BP- 116/83, p-84, O2 sat- 98% at 10:40 am- discharged home with ER precautions. If symptoms persist, recommend follow up with Primary care physician.
40 2021-04-17 numbness, tingling Extreme head ache, irritability, dry mouth, numbness and tingling of my left arm, my tongue feels ti... Read more
Extreme head ache, irritability, dry mouth, numbness and tingling of my left arm, my tongue feels tingly. I feel like I drank about ten red bulls my heart feels like its racing!
40 2021-04-17 numbness Patient reported feeling numbness to her hands and red patches appeared on her face and neck. Patien... Read more
Patient reported feeling numbness to her hands and red patches appeared on her face and neck. Patient was assessed and symptoms were monitored. After an additional 15 minutes of observation, the numbness to the hands and the red patches on face and neck disappeared. Patient left vaccination clinic in stable condition.
40 2021-04-17 pain in extremity Approximately 11 days s/p 2nd vaccination, patient developed calf pain. After the pain persisted for... Read more
Approximately 11 days s/p 2nd vaccination, patient developed calf pain. After the pain persisted for two days she went to the local emergency room and was diagnosed with a DVT. No personal or family history of blood clots. No precipitating life events. No culprit medications. Age appropriate cancer screening up to date.
40 2021-04-17 tremor Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down d... Read more
Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.
40 2021-04-18 weakness Initial soreness at injection site. 12 hours post injection, chills, feverish, weak, and extreme fat... Read more
Initial soreness at injection site. 12 hours post injection, chills, feverish, weak, and extreme fatigue, no appetite
40 2021-04-18 feeling hot Approximately 3 to 4 minutes after receiving my first vaccine, I had a hot feeling travel from my to... Read more
Approximately 3 to 4 minutes after receiving my first vaccine, I had a hot feeling travel from my toes up to my head. I then became dizzy and felt very faint. The tip of my tongue also became numb. I was too embarrassed to alert the hospital worker. The sensation lasted about a minute. However, the last 2 1/2 days I have been having a fast heart rate after doing minimal activities. I feel very winded by the slightest task. I did go to a clinic today to get my vitals checked. They were fine- but I still continue to feel like my heart rate spikes when I do something as minimal as emptying the dishwasher. It?s very scary and uncomfortable and makes me fearful of taking the second shot.
40 2021-04-18 flushing Approximately 50 minutes after injection, having waited the 30 minutes for observation, while drivin... Read more
Approximately 50 minutes after injection, having waited the 30 minutes for observation, while driving home my tongue started to feel wrong and the top started to tingle. Uncertain which direction this was going to go, I drove to the ER (which was near home, close to where I was at the time). I felt light-headed for a little bit just after getting a room and talking with the insurance & copay person. The doctor noticed I was flushed/red, which extended from my face down my chest and shoulders. The reaction didn't seem to progress further than that, thankfully. I was treated with Solumedrol, Famotidine, Benadryl.
40 2021-04-18 pain in extremity, weakness, night sweats Second dose at 9am 4-15-2021 9am- vaccine administered at 9:10 916- heaviness in head 11am- fatigue ... Read more
Second dose at 9am 4-15-2021 9am- vaccine administered at 9:10 916- heaviness in head 11am- fatigue low level 2pm- heavy fatigue. Soreness arm. 4pm- nausea and headache 5:30pm- vomiting 745pm- vomiting and headache severe. Chills started 815pm- vomiting 930pm- vomiting 1005pm- vomiting. No chills. Friday April 16, 2021 1:30am- chills back no fever 4am- no chills 5:30am- chills no fever 7am- woke slight headache and mild body aches. Low energy 12noon- aches worsen 4pm- headache and aches more significant. Heavy fatigue. Chills on and off Saturday April 17, 2021 1am- woke up same symptoms since 4pm. Headache throbbing. Slept until 11am which is very unusual Noon- headache mild. Body aches/pain significant continue. Fatigued. 6pm- woke up after sleeping since 130pm. Headache mild and significant aches/pain continue. 10pm- no headache. Body aches/pain significant. Took a bath to relive aches which helped some. Sunday April 18, 2021 12am- body aches significant return 9am- woke up with significant aches/pain still Tried to move around & cook breakfast. 11:00am- aches/pain worse after moving & cooking. Rested and slept until 3:30pm 4:00pm- pain significant. Took hot bath helped some. Tried stretching. Pushed fluids. 11:00pm-8:00am slept. Monday April 19, 2021 2:00am- woke in a sweat which is unusual 8:00am woke sweaty which is unusual and no muscle pain. More mild muscle aches. Most significant and distressing reaction was the vomiting due to intensity, duration and frequency
40 2021-04-18 tremor Feels "woozy" and light headed, shaky per patient. VS stable. Unable to obtain Pulse Ox due to pat... Read more
Feels "woozy" and light headed, shaky per patient. VS stable. Unable to obtain Pulse Ox due to patient's nail polish. Observed until 1718pm and wants to go home after something to drink. VS continue stable. No symptoms of anaphylaxis.
40 2021-04-19 pain in extremity Arm started hurting around three hours after the first shot. By 9pm that night the pain had spread ... Read more
Arm started hurting around three hours after the first shot. By 9pm that night the pain had spread to my neck and shoulder on the left side and I was not able to turn my head. My left breast also swelled up. This lasted for three days. The second day, I experienced blood pressure flutters if I stood up to fast or drank anything cold, this last only for a day.
40 2021-04-19 pain in extremity I am a breastfeeding mother. I almost exclusively pump and bottle feed. I have not had a menstrual c... Read more
I am a breastfeeding mother. I almost exclusively pump and bottle feed. I have not had a menstrual cycle since my child was born in October because of this. 72 hours after getting this vaccine, I started bleeding heavily. I am also not producing as much milk as I was before the vaccination. Prior to the vaccine I was pumping a total of 6 ounces every 4 hours. After the vaccine I have been pumping about 4 ounces every 4 hours. I have not had any change in my eating or drinking habits that would account for this loss of milk output. I also had a headache and sore arm but that was to be expected. These two issues have since resolved. The bleeding and loss of milk production are ongoing.
40 2021-04-19 pain in extremity About 5 minutes after shot, while seated quietly, sudden onset of coughing and difficulty breathing.... Read more
About 5 minutes after shot, while seated quietly, sudden onset of coughing and difficulty breathing. This is typical of my acute asthma symptoms. It worsened from a few coughs to uncontrollable coughing over about 2 minutes. Took two puffs of albuterol inhaler, coughing and breathing difficulty resolved over another 5 minutes. No further asthma symptoms in week since vaccination. It's unclear if the asthma attack was related to the vaccine. But I often go months without needing to use an inhaler, so timing is suspicious. My usual asthma triggers are environmental allergens (dust, cats), food (hazelnuts), or viral infection. I had been sick with a cold, but with no lingering asthma symptoms for 4 days prior to the vaccine. I also had more typical moderate side effect symptoms the next day (fatigue, sore arm, muscle aches).
40 2021-04-19 tingling pain in the midsternal region and in an area of the left side of her chest. Constant pain, unable to... Read more
pain in the midsternal region and in an area of the left side of her chest. Constant pain, unable to describe. she gets intermittent sharp/stabbing, burning pains in her chest. She has shortness of breath described as difficulty taking in a deep breath. She feels more fatigued than normal. She also complains of whole body tingling and feels like she's having "an out of body experience."
40 2021-04-20 burning sensation Shingles - I received the Pfizer vaccine on a Wednesday afternoon and by Monday I developed a rash a... Read more
Shingles - I received the Pfizer vaccine on a Wednesday afternoon and by Monday I developed a rash and throughout nthe week it was a burning sensation and turned into blisters and went to the Doctor and she diagnosed me with shingles / herpes zoster
40 2021-04-20 flushing Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports throat tightness, mild pain with swallowing (b... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports throat tightness, mild pain with swallowing (but able to swallow), flushing, and blotchy skin on forehead, cheeks, and neck after vaccination. Vital signs: blood pressure 146/93 mmHg (repeat 136/100 mmHg), pulse 74 beats per minute, oxygen saturation 98% on room air. Patient denies chest pain and shortness of breath. Administered oral diphenhydramine and left vaccination clinic stable with symptom improvement and drinking fluids without difficulty.
40 2021-04-20 flushing Patient did not report symptoms until I called about coming in to receive 2nd COVID vaccine. Stated ... Read more
Patient did not report symptoms until I called about coming in to receive 2nd COVID vaccine. Stated her cheeks got very hot, facial flushing on the way home from the clinic after sitting in the clinic for 30 mins on 4/2/2021
40 2021-04-20 hot flush Oral swelling, hot flashes. Patient did not seek medical attention during event, states she self me... Read more
Oral swelling, hot flashes. Patient did not seek medical attention during event, states she self medicated with diphenhydramine within an hour of vaccination. Symptoms completely resolved by next morning. Patient endorsed symptoms during screening for second dose of vaccine 21-days later.
40 2021-04-20 numbness, tingling Tingling and numbness on right side of face and neck.
40 2021-04-20 migraine Severe increase in migraine headaches post vaccine. Saw neurologist. Changed abortive medication. Ad... Read more
Severe increase in migraine headaches post vaccine. Saw neurologist. Changed abortive medication. Added nausea medication. Still struggling with uncontrolled headaches.
40 2021-04-20 pain in extremity Loss of taste, hard of smelling, sore arm
40 2021-04-21 facial paralysis Numbness of tongue on 4/15/21 Right facial droop on 4/16/21 Went to ER on 4/16/21
40 2021-04-21 feeling hot throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling,... Read more
throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.
40 2021-04-21 flushing Patient received first dose of COVID vaccine today, appointment time 1430, received first dose vacci... Read more
Patient received first dose of COVID vaccine today, appointment time 1430, received first dose vaccine at 1433. After receiving vaccine, patient sat in observation area and reported her voice "going away" sharing that with other allergies her voice often softens and she has a hard time communicating. No signs of shortness of breath, respirations even and not labored, oxygen sat at 100%, pulse 102, BP 112/66. Face flushed. Administered 1ml of benadryl IM, 50 mg total. Patient still expressing difficulties verbalizing and now stating a small feeling of tightness in her throat, face continued to be flushed. Administered epi pen to left thigh. Called 911. BP 110/60, 109, 100%. Gave report to ED RN and to paramedic responding. Patient then transferred to ED with paramedic assist. At time of transfer, patient reporting improvement with ability to communicate via voice, face less flushed and improved tightness in her throat.
40 2021-04-21 grand mal seizure, tremor Nausea, vomting, palpitations starting 10 minutes after vaccine administration. Generalized Tonic S... Read more
Nausea, vomting, palpitations starting 10 minutes after vaccine administration. Generalized Tonic Seizure 2 days after vaccine. CT head negative in ED, discharged 8 days after vaccine, presented to clinic with continued daily seizure like activity, inability to stand due to leg shaking. Exam notable for Lower extremity myoclonus. Then, admitted to hospital on 4/8. MRI brain unremarkable. EEG with potential epileptiform activity. Patient discharged on 4/10 on keppra for seizure prophylaxis, Home health physical therapy and neurology follow up.
40 2021-04-21 muscle spasms Pt went to the ER on 4/19/21 with vaginal bleeding and cramping at approx. 6 wks gestation per LMP. ... Read more
Pt went to the ER on 4/19/21 with vaginal bleeding and cramping at approx. 6 wks gestation per LMP. HCG >7,000 on 4/19/21. Presented to clinic on 4/22/21 with chills, nausea, vaginal bleeding, sent for u/s, no IUP seen, HCG today 500.
40 2021-04-21 night sweats, tingling, tenderness -LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF REC... Read more
-LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF RECEIVING VACCINE - LASTED FOR 6 DAYS -UNABLE TO MOVE LEFT ARM, RAISE IT, OR LIFT ANYTHING FOR THE PAST 18 DAYS -UNABLE TO GRASP OBJECTS WITH LEFT ARM FOR THE PAST 18 DAYS -UNABLE TO SLEEP ON LEFT SIDE - CAUSES EXTREME PAIN -TINGLING AND NERVE SHOOTING PAIN ON LEFT ARM FROM FINGERS TO NECK, FRONT AND BACK CHEST LEFT SIDE -MUSCULAR NODULE DEVELOPED ON LEFT SHOULDER UP TO MY KNECK - CAUSING SEVERE EAR PAIN -EXTREME FATIGUE - LETHARGIC FOR THE PAST 18 DAYS -SEVERE JOINT/PAINT THROUGH OUT ENTIRE BODY -LOST OF TASTE -NIGHTSWEATS FOR PAST 18 DAYS -FEVERS RANGING BETWEEN 99.0 - 103 F FOR PAST 18 DAYS -NAUSE FOR PAST 18 DAYS -LOST OF APPETITE -DIARRHEA AND LOOSE STOOLS FOR THE PAST 8 DAYS (NO BLOOD) -BRAIN FEELS FOGGY ALL THE TIME - FEELING AS IN A DAZE FOR PAST 18 DAYS -SHORTNESS OF BREATH - JUST FROM WALKING OR MOVING AROUND -SKIN IS SUPER SENSITIVE AND ITCHY -UNABLE TO DRIVE BECAUSE OF THE FATIGUE AND UNABLE TO USE LEFT ARM. -UNABLE TO WORK - RELYING ON OTHERS TO TAKE CARE OF ME.
40 2021-04-21 pain in extremity Several days after 2nd dose of Pfizer I started experience increased pain in my jaw as well as my ri... Read more
Several days after 2nd dose of Pfizer I started experience increased pain in my jaw as well as my right thumb. I do have TMJ though it is controlled/mild and haven?t had issues with it in a few years. After 2nd dose experience pain and discomfort throughout the day. I have also been experiencing increased pain and discomfort in my right thumb where I believe I have some signs of arthritis since receiving the 2nd dose.
40 2021-04-21 tingling Tingling all down arm into finger, feels like my arm is asleep.
40 2021-04-21 tingling A little more than an hour after receiving the shot My body broke out in hives all over it. My skin ... Read more
A little more than an hour after receiving the shot My body broke out in hives all over it. My skin was red and splotchy everywhere. My skin was in credibly hot to the touch and tingly. It remains that way for around two hours while I tried to contact a doctor or nurse. I was advised by the nurse to take an Antihistamine Which I did and Within about 40 minutes all of the symptoms were resolved. 48 hours later all of the symptoms returned and I again took an antihistamine and they resolved. 11 days after the second reaction all of the symptoms returned again. This time I did not take an antihistamine and they resolved on their own within an hour. Eight days after the third reaction all of the symptoms returned again. I did not take an antihistamine and they resolved within an hour.
40 2021-04-21 seizure Patient fell to the floor and was seizing within minutes of receiving the vaccination. Patient had a... Read more
Patient fell to the floor and was seizing within minutes of receiving the vaccination. Patient had an injury to the forehead. Patient was placed in the recovery position by pharmacy staff and EMS was notified. After recovering, patient stated that she had had similar adverse reactions following injections but she had denied ever having an adverse reaction to a vaccination or any history of seizure disorders when being screened by the pharmacist prior to administration. Patient was evaluated by EMS but she declined to be taken to the hospital in an ambulance.
40 2021-04-22 weakness RN called to vaccine room to assess patient who reports feeling dizzy, and severe HA immediately aft... Read more
RN called to vaccine room to assess patient who reports feeling dizzy, and severe HA immediately after pfizer injection @15:25pm. Patient escorted to medical bay area to further assess. Patient reports feeling "dizzy with 9/10 headache". Denies worst HA of life. When RN asked patient her name and where she was, patient had trouble responding and appeared to be disoriented staring off and not responding to questions. PA arrived on scene to bedside and performed neurological assessment. Pt slow to respond however A and O x 4, pt reports baseline weakness to RUQ/RLE. PA and RN recommended patient go to the emergency room due to medical history and patient's presentation. Patient started crying hysterically and refused 911 call. Spouse of patient called to bedside to gather more information.Husband confirmed hx of MS and baseline right sided weakness of RUE/RLE. No previous history of epi use with allergic reaction Pt intermittently slow to respond to questions. Then at 16;02 pt reported moderate throat Itchiness. 25 mg IM benadryl given to patient. Pt reported improvement of itchiness. RN and PA again strongly recommended ER transport to higher level of care. Both agreed, and 911 called at 1614. At this time, patient is AAOx3, but is slow to answer questions. Will continue to monitor. EMS arrived on scene @ 1635. Transported to ER at 1645 to Hospital.
40 2021-04-22 numbness, tingling Left side of jaw/upper left neck became swollen after numbness/tingling episode after eating a hour ... Read more
Left side of jaw/upper left neck became swollen after numbness/tingling episode after eating a hour after COVID injection left arm. Went to urgent care, doctor stated he had not heard of this being a side effect of COVID vaccine and felt it was inflammation of salivary gland . He prescribed a antibiotic and told me to f/u if no better, symptoms continue. I had experienced no issues prior to the vaccine. (In regards to salivary gland)
40 2021-04-22 migraine I have Had A MIGRAINE Along with HIGH BLOOD PRESSURE... It started 2 weeks after my 2nd Pfizer Shot.... Read more
I have Had A MIGRAINE Along with HIGH BLOOD PRESSURE... It started 2 weeks after my 2nd Pfizer Shot... I was admitted into the hospital because after A Cat Scan, MRI, And A Spinal Tap looking for Menengitis They Couldn't Find ANYTHING WRONG... I was in the Hospital for 8 days... They where unsure WHAT WAS WRONG SO THEY TREATED ME WITH MANY DIFFERENT MEDICATIONS INCLUDING HEPRINE FOR BLOOD CLOTS... AS OF TODAY 4/23/2021.. I CONTINUE TO EXPERIENCE THESE UNBEARABLE HEADACHES... HAVEN'T SLEPT IN A MONTH.. AND I CONTINUE TO HAVE SUPER HIGH BLOOD PRESSURE... IF THIS CONTINUES I AM NOT SURE HOW I WOULD LIVE... THE PAIN IS HORRIBLE... SO SO BAD
40 2021-04-22 nerve pain, fibromyalgia Headache, confusion, muscle and joint pain, inflammation, fatigue, etc etc. Including LUPUS FLARE- ... Read more
Headache, confusion, muscle and joint pain, inflammation, fatigue, etc etc. Including LUPUS FLARE- aggravated Systemic Lupus- which still continues 2 months later.. Also, developed DVT?s in both arms- previously dx.ed with APS- Antiphospholipid Syndrome and was already on anticoagulant therapy. Possible clot in/near artificial heart valve- further testing being done next week. After 2nd dose Also increase in Lupus Flare, as well as severe Fibromyalgia Flare- aggravated FMS. Extreme muscular pain/neurological pain, confusion, fatigue, etc etc.
40 2021-04-22 pain in extremity Pfizer-BioTech COVID-19 Vaccine EUA Lightheadedness around 4 hours post vaccine. Ears and face st... Read more
Pfizer-BioTech COVID-19 Vaccine EUA Lightheadedness around 4 hours post vaccine. Ears and face stinging sensation 7 hours post vaccine. Sore Arm and sore neck.
40 2021-04-22 tingling Stiffness and pain in thumb knuckle/ hurts to move on the hand on the side where I received a vaccin... Read more
Stiffness and pain in thumb knuckle/ hurts to move on the hand on the side where I received a vaccine pain and wrist/mild tingling
40 2021-04-23 migraine, tingling Vertigo, presyncope, migraine, menstruation, back ache, nausea, tingling In the fingers, tinnitus
40 2021-04-23 tingling, migraine Symptoms started approximately 23 hours after my first Pfizer dose. I had a visual disturbance that... Read more
Symptoms started approximately 23 hours after my first Pfizer dose. I had a visual disturbance that lasted ten minutes. First my vision went blurry at the edges, then I saw flashes of light and eventually I saw a zigzag pattern across my vision. Since this happened the left side of my face primarily above and below my eye has been tingly and numb feeling, as well as slightly swollen. I have also had vertigo for 11 days now that is getting worse instead of better.
40 2021-04-24 weakness, hot flush, migraine Diminished ovarian reserve/diminished reserve; fever; chills; hot flashes; nausea; vomiting; migrain... Read more
Diminished ovarian reserve/diminished reserve; fever; chills; hot flashes; nausea; vomiting; migraine headache; vertigo; weakness; They obtained an FSH level and it had skyrocketed from previous values not long before; my ovaries had shrunk in size by approximately half; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), first dose via intramuscular, administered in right arm on 19Dec2020 09:30 at a single dose (lot number and expiry date were not reported); and then received the second dose on 02Jan2021 09:30 (lot number and expiry date not reported), intramuscularly administered in right arm as a single dose; for COVID-19 immunisation. Medical history included eosinophilic esophagitis and asthma. The patient had no known allergies. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications which were taken in two weeks prior to vaccination included bupropion hydrochloride (WELLBUTRIN) and ethinylestradiol, norethisterone acetate (LOESTRIN), taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. On 19Dec2020, the patient experienced diminished ovarian reserve. Patient stated that she was extremely symptomatic after both vaccines and starting on 19Dec2020 had experienced fever, chills, hot flashes, nausea, vomiting, migraine headache, vertigo and weakness. The hot flashes persisted and worsened after each subsequent vaccine, prompting her to go to my MD. They obtained an FSH level on 19Dec2020 and it had skyrocketed from previous values (dates unspecified; unknown results) not long before. An ultrasound on 19Dec2020, showed that her ovaries had shrunk in size by approximately half and she had diminished reserve. Patient was now on supplemental hormones and will be for many years to come as she was only 40. Patient know the vaccine caused this. It was too great of a coincidence. Adverse events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. As a result of the events reported patient was now on hormonal replacement therapy. The patient was tested for covid post vaccination which included nasal swab/Covid test on 14Mar2021 as negative. The outcome of the events reported was not recovered. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded, for events fever, chills, hot flashes, nausea, vomiting, migraine headache, vertigo and weakness, conversely the suspect drug is considered very unlikely related for other gynecological disturbances. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
40 2021-04-24 cold sweat From 10pm on Monday 5 April until the morning of Wednesday 7 April (approximately 33 hours) I had a ... Read more
From 10pm on Monday 5 April until the morning of Wednesday 7 April (approximately 33 hours) I had a severe reaction to the second dose of the vaccine. The night of 5 April I had extreme chills, uncontrollable teeth chattering, and freezing sweats. I had sharp shooting pains in my feet, legs, hands, and arms that lasted 24 hours. I also had sharp shooting pains in the back of my head and then it began in my ears. When moving my head for the next full day I experienced extremely sharp pain in one or the other ear. Sometimes the pain returned in my arms. I had tightness in my chest, shallow breathing, and extreme fatigue but also could not sleep due to the pains and the sharp ear pains when turning my head. I had a fever from 100-101 degrees from the first night and still had 101 at 10pm on 6 April (24 hours later). That night I took a Motrin due to the sharp ear pains. (The first night I had only taken Tylenol.) Throughout the second night, I woke up many times drenched in sweat and upon waking up on the following morning, my fever had broken. Throughout day 3 (Wednesday 6 April), I still had tightness in my chest, shallow breathing, and periodic sharp ear pain when moving my head but my fatigue, chills, and fever had subsided.
40 2021-04-24 feeling cold, weakness Fever, chills, and aches after 13 hours. Headache and chills and weakness after 24 hours
40 2021-04-24 feeling hot The patient was sweating and feeling hot. Called EMS at the patient's request and the patient's was ... Read more
The patient was sweating and feeling hot. Called EMS at the patient's request and the patient's was checked at the scene and released with no issues.
40 2021-04-24 hot flush Dizziness occurred within the first hour after injection and lasted about 2-3 hours. About 7 hours a... Read more
Dizziness occurred within the first hour after injection and lasted about 2-3 hours. About 7 hours after injection, I developed a headache. Overnight, I had a hot flash. When I woke up the following morning, about 19 hours after injection, I had a fever. I went to work and developed chills and sweats (about 21-22 hours after injection) that lasted for at least 5 hours. I also had nausea at that time. I did take 1,000 mg of acetaminophen after checking my temperature that morning and again in the afternoon. I went home early from work, around 3 pm (about 30-31 hours after injection) and went to bed. I slept for 13 hours and when I awoke the following morning, I had a minor headache and some malaise, but it was much improved. I took 1,000 mg of Tylenol and felt better in the afternoon (about 53 hours after injection).
40 2021-04-24 pain in extremity Patient called call center 4/22/21. Pt c/o headache since Tuesday (4/20/21). Pt said she took 1tab t... Read more
Patient called call center 4/22/21. Pt c/o headache since Tuesday (4/20/21). Pt said she took 1tab tylenol yesterday without relief. Per pt, she received a pfizer covid-19 vaccine on Friday, 4/16 at expo. Pt said she had arm pain and felt very tired until Monday, when she started to feel "normal" and on Tuesday pt developed a headache and headache has been lingering since. pt was scheduled with urgent care provider for visit on 4/23/21.
40 2021-04-25 inability to speak Within 3-5 minutes of receiving the vaccine, patient starting complaining of difficulty breathing th... Read more
Within 3-5 minutes of receiving the vaccine, patient starting complaining of difficulty breathing that quickly progressed to the inability to speak. Patient noted to have some airway inflammation and very large adenoids. Within another minute she started to lose consciousness. Epinephrine 0.3 mg IM was administered via EpiPen alonge with Diphenhydramine 50 mg IM. Patient responded within 1 minute and improved to the point of speaking freely, drinking water, and reporting full recovery. Patient was moved to the Emergency Department for additional monitoring and treatment where she received methylprednisolone and famotidine. Patient was discharged home later that day. Patient reports full recovery and willingness to receive the booster dose. A second dose, using Janssen vaccine is planned. Patient also now reports that she had a previous similar reaction to receiving a Vitamin B12 injection.
40 2021-04-25 feeling cold, numbness, tingling swallowing , numbness, tingling and coldness
40 2021-04-25 pain in extremity Soar stuff arm, severe cold symptoms
40 2021-04-25 pain in extremity On April 17th developed pain in BL arms and feet..4/19-calling her pcp tomorrow and if any worsening... Read more
On April 17th developed pain in BL arms and feet..4/19-calling her pcp tomorrow and if any worsening will go to the ED tonight
40 2021-04-25 tingling, numbness achiness in joints (more left side than right side), specific to knee, ankle and elbow. Additional t... Read more
achiness in joints (more left side than right side), specific to knee, ankle and elbow. Additional tingle/numbness feeling in extremities (fingers and toes).
40 2021-04-26 numbness, tingling Tingling and numb sensation beginning at left hand fingertips and emulating upwards to the shot area... Read more
Tingling and numb sensation beginning at left hand fingertips and emulating upwards to the shot area in the first fifteen minutes. Sensation turned to stinging sensation which continued up through through the shoulder and into the base of the neck and remained until sleep. Heating pad was used to reduce sting. Numbness and tingling continued for the next three days alternating between just fingers and fingers and arm. Stinging was reduced and there is now continued numbness and tingling in the left hand fingers, in particular when fingers are being used for typing or other activity. Sensation continues to date of report.
40 2021-04-26 numbness, tremor, weakness, flushing, tingling Wed, April 14: headache, light headed, feeling of going to pass out, blurred vision, very tired, we... Read more
Wed, April 14: headache, light headed, feeling of going to pass out, blurred vision, very tired, weak, diarrhea. Thur April 15 ? very light headed, feeling of going to pass out, numb pinky, very weak, very shaky, very tired. Went to ER after almost passing out they gave me fluids, did a chest xray and ekg, covid test, pregnancy test. They sent me home saying I was dehydrated. ? slept for 4 hours after ER, felt tired, hard to focus, diarrhea then that night slept all night. Fri April 16 ? a bit better in morning but vision still not right, at dinner table felt drunk (did not have any alcohol), very tired, face felt flushed (no fever), hard to focus, headache came on before bed (took 2 Aleve) Sat April 17 ? tired, went to doctor for additional blood work, slept after appointment, face flush (no fever), vision still not right. Doctor said this is likely vaccine related. Sun April 18 ? felt same as Saturday Mon April 19 ? very tired, vision still not right, hard to focus at work, want to sleep, face felt hot and tingly (no fever) Tue April 20 ? allergy type symptoms in morning. Sneezing, runny nose, slight headache. These symptoms went away. From April 21-28 - other symptoms mostly going away except vision issues. April 28th most symptoms went away but vision is still blurry, see floaters, feels like I have Vaseline over my eyes. Going to see an eye doctor ASAP.
40 2021-04-26 numbness Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm st... Read more
Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back. Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.
40 2021-04-26 numbness Numbness in face, tongue and arm
40 2021-04-26 numbness Numbness on both sides of my face, fluttering feeling in brain and tinnitus in both ears
40 2021-04-26 pain in extremity Chills; Body aches; Fever; Sweating; Stomach pain; Pain in legs; This is a spontaneous report receiv... Read more
Chills; Body aches; Fever; Sweating; Stomach pain; Pain in legs; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER2613) via an unspecified route of administration on 27Mar2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included heart issues (supraventricular tachycardia [SVT]). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included acebutolol, diphenhydramine (BENADRYL), and guaifenesin (MUCINEX) from unknown dates for unknown indications. On 27Mar2021 the patient experienced chills, body aches, fever, sweating, stomach pain, and pain in legs. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of chills, body aches, fever, sweating, stomach pain, and pain in legs were recovering. It was also reported that since the vaccine the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected
40 2021-04-26 pain in extremity Mild arm soreness - about four hours later; about 5 1/2 hours later a mild headache. I did take Tyle... Read more
Mild arm soreness - about four hours later; about 5 1/2 hours later a mild headache. I did take Tylenol which helped the symptoms. I had mild nausea and in the middle of the night and I took a Zofran - which helped with my nausea. I still had a mild headache the next morning and I took another Tylenol - but the end of that day I was totally fine.
40 2021-04-26 pain in extremity I took a Benadryl one hour after my shot - because I felt my throat was getting a little itchy. And ... Read more
I took a Benadryl one hour after my shot - because I felt my throat was getting a little itchy. And I do get anxiety. The first side affect - my arm got super sore. That lasted 24 hours. The second day, about 26 hours later (from vaccine) - I got a mild backache. Mild headache, too, which I actually got 7 days after the vaccine. Five days after the vaccine, GI upset - diarrhea - it lasted five days. I talked to my doctor about it - my doctor told me to stay hydrated.
40 2021-04-26 pain in extremity Received the vaccine at 9:30 am. Originally felt fine with mild soreness in the arm. Woke up around... Read more
Received the vaccine at 9:30 am. Originally felt fine with mild soreness in the arm. Woke up around 2:15 am to use the restroom, and got extremely dizzy... started to feel weird, and felt like there was a rush all over. My head started to feel like it was closing in and there was a static, crackling, speaker-like sound along with tinnitus in my ears making it feel like I was in a tunnel. I sat on the floor and waited several minutes until the feeling passed and was able to get back into bed. I waited several more minutes until I felt "normal" again. Was able to get back to sleep, and feel better this morning, with no dizziness, but will continue to monitor any additional symptoms closely.
40 2021-04-26 tingling Generalized itching w/o hives, HX of asthma. Feels seasonal allergies are getting worse. No airway e... Read more
Generalized itching w/o hives, HX of asthma. Feels seasonal allergies are getting worse. No airway edema. Given 25mg PO Benadryl. Pt states she usually takes 50 -75mg at home and request that but is driving home, denied by medical team. Feels symptoms have resolved @1140. Reports "tingling" all over body from anxiety.
40 2021-04-26 tingling Paresthesia - R arm and R leg, intermittent, present for over 2 weeksCovid21#
40 2021-04-26 tingling First dose given 03/17/2021: momentary adverse reaction: racing heartbeat. Second dose given: 04/08/... Read more
First dose given 03/17/2021: momentary adverse reaction: racing heartbeat. Second dose given: 04/08/2021: no immediate adverse reaction other than soreness at injection site & general feeling of unwellness. Days after, tingling in the fingersÂ…until the 17th, rib and back pain began. Pain radiated and worsened over the next two days. Was seen by PCM 04/20/2021, sent for XRAY, CAT scan, and ER, immediate diagnosis of Pulmonary Embolism in the right lung, as well as lung infarct in lower portion.
40 2021-04-27 bell's palsy Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-... Read more
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 11Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient experienced Bell's Palsy on 28Mar2021 and was diagnosed on 29Mar2021. Therapeutic measures were taken as a result of the event. The outcome of the event was not recovered. The event resulted in emergency room/department or urgent care and disability or permanent damage.
40 2021-04-27 burning sensation Patient reported feeling itchy and "on fire" inside shortly after getting her vaccine. She said it ... Read more
Patient reported feeling itchy and "on fire" inside shortly after getting her vaccine. She said it took 5 doses of Benadryl to stop the reaction. Then her chest got tight later that day. She did not go to a doctor or seek emergency help. She said her autoimmune condition was already flared when she received the vaccine, and getting the vaccine made it flare up even worse. She denied hives, but she did say she developed a rash on her back. She came in today for her 2nd dose, but I advised her to try to talk to her doctor(s) about the reaction and see if they would be able to give her the 2nd dose since they would be more equipped to handle a potential anaphylactic reaction. She said she has not seen any of her doctors since the pandemic started, but that she would try to reach out to them.
40 2021-04-27 numbness, nerve injury lesions on my spinal cord which may result in permanent nerve damage; lesions on my spinal cord whic... Read more
lesions on my spinal cord which may result in permanent nerve damage; lesions on my spinal cord which may result in permanent nerve damage; numbness which is increasing day by day; This is a spontaneous report from a contactable consumer (patient). A 40-year old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: ER8732), via an unspecified route of administration, administered in the left arm on 25Mar2021 11:00 (at the age of 40 years-old) as single dose for covid-19 immunisation. Medical history included penicillin allergy and shingles outbreak. Patient previously received bnt162b2 (lot number: EN6200) on 01Mar2021 at 09:00 in the left arm for covid-19 immunization and experienced shingles outbreak. Concomitant medication included doxycycline monohydrate taken for an unspecified indication, start and stop date were not reported. The patient was now (Mar2021) experiencing numbness which was increasing day by day. She had an MRI scan last week (Mar2021) and it's showing lesions on her spinal cord which may result in permanent nerve damage. She will be speaking with a neurologist this week and doing additional test/scans. The patient underwent other lab tests and procedures on 07Apr2021 which included Nasal Swab (for sars-cov-2 test) with negative result. the outcome of events was reported as not recovered. It was unknown whether treatment was received. The events were considered as serious,involving persistent or significant disability or incapacity. No follow-up attempts possible. No further information expected.
40 2021-04-27 tingling, numbness NUMBNESS AND TINGLING R SIDE
40 2021-04-28 numbness Likely bursitis of shoulder according to her PCP. Patient is experiencing pain and numbness. She is ... Read more
Likely bursitis of shoulder according to her PCP. Patient is experiencing pain and numbness. She is also experiencing immobility.
40 2021-04-28 nerve pain, muscle spasms Cervical radiculopathy; muscle spasms; neurological pain down right arm; bursitis right elbow; menst... Read more
Cervical radiculopathy; muscle spasms; neurological pain down right arm; bursitis right elbow; menstrual changes - ovarian cyst; menstrual changes - ovarian cyst; carpal tunnel; This is a spontaneous report from a contactable nurse (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 28Dec2020 10:00 (lot number and expiration date were not reported) as single dose (at the age of 40-years-old) for COVID-19 immunisation. The patient was vaccinated in a hospital. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient had no other vaccines in four weeks. The patient did not have COVID prior to vaccination. On 01Jan2021 at 6 pm, the patient experienced cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes - ovarian cyst and carpal tunnel. The adverse events resulted in a doctor/healthcare professional clinic visit and was considered a disability/permanent damage. The patient received treatment of "PT, Mobic, soma, ultram and trigger point injection. The patient has not recovered from the events. The patient had a negative nasal swab test on 16Jan2021. The patient received the second dose administered in the left arm on 19Jan2021 (lot number and expiration date were not reported) at a single dose. Information about the lot/batch number has been requested.; Sender's Comments: The events cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes, ovarian cyst and carpal tunnel most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-04-28 pain in extremity Sore arm 4/24, am Severe fatigue 4/24, pm Fatigue 4/25, all day 4/26, all day - severe body aches, s... Read more
Sore arm 4/24, am Severe fatigue 4/24, pm Fatigue 4/25, all day 4/26, all day - severe body aches, severe fatigue, low fever, chills, severe headache, nausea 4/27 - headache, nausea 4/28 - headache, nausea
40 2021-04-29 breast pain, feeling hot The evening of the vaccine I started getting sore ovaries, which continued for about 3 days, waking ... Read more
The evening of the vaccine I started getting sore ovaries, which continued for about 3 days, waking me up that first night with the pain. It felt like they were hot and aching, like they were working very hard, something I haven't experienced before. This was 5 days after my last period finished. I had spotting the next day, which I never have, and then my breasts became very sore, lumpy and tender for the next week or more - very concerning as I have had a fibroadenoma before. Symptoms were similar to being pregnant, but I have just started my next period, and did a pregnancy test which came back negative. I have also had ongoing light tinnitus, which started a few days after the vaccine. Again, I haven't had this before, and it has been almost 3 weeks now and it is still at the same intensity. I am very worried about getting the second vaccine next week.
40 2021-04-29 feeling cold, weakness Around 3pm I began feeling so weak and sleepy I was struggling to keep my eyes open while typing ema... Read more
Around 3pm I began feeling so weak and sleepy I was struggling to keep my eyes open while typing emails for work. By 8pm I had a mild fever and was freezing. The next day the fever persisted and I have aches and chills. I slept most the day. The fever did not break till the next morning. I was only taking acetaminophen for the fever and pain.
40 2021-04-30 cold sweat cold sweats; lethargic; fever; chills; stiff, painful neck (back of neck) (turning radius without mo... Read more
cold sweats; lethargic; fever; chills; stiff, painful neck (back of neck) (turning radius without more pain was very small); painful neck (back of neck) (turning radius without more pain was very small); headache; large swollen lymph node in neck (right side); Pain in neck irradiates more when coughing; 1 week after 2nd dose nose infection very prominent again (same nostril); This is spontaneous report from a contactable consumer (patient herself). A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via an unspecified route of administration in right arm on 19Feb2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included panic disorder. Patient (self) has no underlying medical issues outside of panic disorder. No known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), trazodone, doxycycline, sulfamethoxazole, trimethoprim (BACTRIM); All received in two weeks within the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on 28Jan2021 as a single dose for COVID-19 immunisation and presented with a nose infection (left nostril, suspected MRSA), prescribed doxycycline for 7 days. Infection reduced (but not completely resolved). The patient did not receive other vaccine in four weeks. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. It was reported that, second dose 19Feb2021 approx. 1 week after 2nd dose (on an unspecified date in 2021) nose infection very prominent again (same nostril), prescribed Bactrim for 10 days. On 02Mar2021, patient experienced lethargic, fever, chills, stiff, painful neck (back of neck) (turning radius without more pain was very small), headache, large swollen lymph node in neck (right side). Pain in neck irradiates more when coughing. On 03March2021, patient experienced fever, chills, and cold sweats in addition to the same issues as 02March2021 with no resolve or progress on symptoms reducing. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included rapid COVID test: Negative, nasal swab: Negative on 04Feb2021 (performed one week after 1st dose), blood work: Nothing standing out to support symptoms, heat CT: Nothing standing out to support symptoms, neck CT: Nothing standing out to support symptoms completed in the ER, nasal swab: Negative, rapid COVID test: Negative on 02Mar2021. The events were considered as non-serious by the consumer. The patient was treated with Bactrim, fluids. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021235826 Similar report from same reporter
40 2021-04-30 numbness Patient received vaccination at location listed and came into her pharmacy the day after vaccination... Read more
Patient received vaccination at location listed and came into her pharmacy the day after vaccination to report a red, swollen area around the vaccination site. It is about 3 inches wide, lower than deltoid region of the arm, almost halfway between the shoulder and elbow. It is more posterior, warm to the touch. The patient also reports numbness in her left hand shortly after vaccination and sudden leg numbness day after vaccination that recovered. Informed patient to contact location that gave vaccination but clinic is closed for the weekend. Also encouraged patient to seek medical attention as soon as possible. She was considering an emergency room visit or contacting PCP on Monday, unsure of outcome.
40 2021-05-01 numbness, tingling Right arm & side numbness, pins & needles feeling Lost of strength in right hand Itching sensation o... Read more
Right arm & side numbness, pins & needles feeling Lost of strength in right hand Itching sensation on right side of neck
40 2021-05-01 numbness Extreme body aches, headache, extreme chills, fever, numbness in fingers and toes, dizzy and light h... Read more
Extreme body aches, headache, extreme chills, fever, numbness in fingers and toes, dizzy and light headed, lasted for about 5 hours. then broke out into hives or rash on neck and chest, underarms, hips and upper thighs that are starting to subside 3 days later.
40 2021-05-01 pain in extremity Vomiting, headache, chills, body aches, fatigue, redness around injection site, sore arm. All lasted... Read more
Vomiting, headache, chills, body aches, fatigue, redness around injection site, sore arm. All lasted about 12 hours, except red arm. Still large red circle.
40 2021-05-02 slurring, tingling Three hours after receiving my first Covid vaccine, I suddenly got two large bumps on my tongue. Abo... Read more
Three hours after receiving my first Covid vaccine, I suddenly got two large bumps on my tongue. About a minute later, I couldn't speak clearly. Next, I got extremely dizzy, to the point I couldn't stand up. After that, I got a rash across my chest, then my shin started tingling. Finally, my scalp started tingling as well. This went on for about 10 minutes and then each symptom went away, one by one, until I was completely fine, as if it never occurred. I had not gone anywhere or done anything out of the ordinary that day besides drive from my home office to the fairgrounds for my shot and then came straight home. I don't know if I am supposed to get my second shot on 5/17/21, as my doctor told me I need to talk to the CDC.
40 2021-05-02 numbness Arm went numb within and hr. Resulted in multiple neurological symptoms . Face numbness, leg weakn... Read more
Arm went numb within and hr. Resulted in multiple neurological symptoms . Face numbness, leg weakness and numbness.
40 2021-05-02 muscle spasms, pain in extremity, nerve pain Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in bo... Read more
Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in both legs and ringing in both ears. Tinnitus. And I've did not have this before my vaccination.
40 2021-05-02 pain in extremity, weakness Initially, my arm started throbbing in the afternoon of the first day. Then I developed chills and ... Read more
Initially, my arm started throbbing in the afternoon of the first day. Then I developed chills and started in the evening about 12 hours after my shot. I went to bed. When I woke up in the morning, I felt nauseous. I got out of bed at about 8am to take 2 tylenol and shower hoping that I'd feel better. While in the shower, I suddenly felt like I couldn't breathe and needed air. The moments after that are bit hazy, but I can tell you somehow I found myself crashed into the window on the opposite wall of my bathroom. Then I somehow made it out of my bathroom and somehow fell head first onto my carpeted floor of my bedroom. I think I must have passed out for a minute. Someone in my house heard me fall and came to help me back into bed and then I fell asleep in bed for the next 5 hours. I woke feeling better, but not well. I didn't feel considerably better until the next day. My right arm still has not regained its strength completely.
40 2021-05-02 pain in extremity Headache stomach issues and arm pain Thursday chest pain and shortness of breathe went to the er had... Read more
Headache stomach issues and arm pain Thursday chest pain and shortness of breathe went to the er had blood clots
40 2021-05-02 tingling After receiving the first dose in my left arm, I immediately thought it was more painful than I anti... Read more
After receiving the first dose in my left arm, I immediately thought it was more painful than I anticipated. When I sat down to self monitor, I felt tingling sensations in my left arm. I assumed it was just a normal reaction. I never had any injection site issues, no swelling or inflammation or pain at the site. No redness. Each day after the dose, I have a throb in the same area with shooting pain and tingles. The throb is about 6 inches below the injection site. The throb starts there and then radiates a tingling feeling outwards. It occurs randomly throughout the day. It hasn't stopped since the first dose. I had the second dose in my right arm because of this. It didn't hurt as much as the left injection and have had no issues in my right arm. Besides these symptoms, I was tired for the first day with a headache and general body aches.
40 2021-05-02 tingling Tingling in right hand. Stable, released from vaccination site.
40 2021-05-02 cold extremities Cold feet when the rest of my body is warm; sore, still feet
40 2021-05-03 bell's palsy I?m having bell palsy symptoms
40 2021-05-03 feeling cold Everything was fine until the next day at 11am, when I started feeling foggy, achy, heachahe, chille... Read more
Everything was fine until the next day at 11am, when I started feeling foggy, achy, heachahe, chilled, and feverish. Now coming up on Wednesday, 5 days later, I still have a fever that will only stay down if I take ibuprofen, and as soon as that wears off, 2-3 hrs later, I?m having chills and the fever spikes back up to 102.5.
40 2021-05-03 numbness, tingling, pain in extremity With day my right arm became numb every night to where I couldn?t feel it. It progressively gotten w... Read more
With day my right arm became numb every night to where I couldn?t feel it. It progressively gotten worse. A week later my left arm started becoming numb with sleep. 2.5 weeks later bilateral lower extremities. I wake up unable to move them and it?s painful. Once I force movement it gets better. During the day I only have mild tingling in all 4 extremities but it?s getting worse. I did not get my second vaccination today.
40 2021-05-03 migraine Rapid heart rate, dizziness within 10 mins after injection. Severe migraines day 2-4 after vaccine. ... Read more
Rapid heart rate, dizziness within 10 mins after injection. Severe migraines day 2-4 after vaccine. Loss of appetite day after vaccine (4/26/2021 -current 5/4/2021)
40 2021-05-03 night sweats Gradual onset of night sweats, unexplained, in spite of hormone replacement, starting ~ 6wk after se... Read more
Gradual onset of night sweats, unexplained, in spite of hormone replacement, starting ~ 6wk after second injection, occurring 2-3x/wk Symptoms are mild/manageable, but I have heard some others with similar symptoms of hot flashes/night sweats, so thought I would report.
40 2021-05-03 tremor, pain in extremity, night sweats, weakness Approximately 11 hours after 2nd shot, I began feeling weak, shakey, and nauseous at bedtime. I went... Read more
Approximately 11 hours after 2nd shot, I began feeling weak, shakey, and nauseous at bedtime. I went to bed, but could hardly sleep. I was restless with a very sore left arm, body aches, and covered in sweat throughout the night. I took Tylenol at 1AM and was able to sleep for about 3 hours. My nausea got worse overnight and into the next day, as well as loose stools. I took Pepto Bismol for that. I had a headache and backache the next day, which I took Tylenol for. By night of day 2, I was no longer miserable, just tired. My arm barely hurt after the first night of shot #2, but hurt for 2-3 days after the 1st shot.
40 2021-05-04 bell's palsy, numbness Within 24 hours of my second dose of Pfizer vaccine I?ve got rushed to the emergency with loss of fe... Read more
Within 24 hours of my second dose of Pfizer vaccine I?ve got rushed to the emergency with loss of feeling and numbness on my right side face where I was diagnosed with Bell?s palsy
40 2021-05-04 hypersensitivity of all senses, burning sensation shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blister... Read more
shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blistering, weeping, oozing and kind of on fire type of feeling; hives and a rash that continues to get worse; hives and a rash that continues to get worse; When clothes touching it hurts, it is very uncomfortable; injection site soreness; This is a spontaneous report from a contactable registered nurse, the patient. This 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151; Expiration Date: 01Jul2021) via an intramuscular route of administration in the left arm on 14Apr2021 09:00 (at the age of 40-year-old) as single dose for COVID-19 immunization. Medical history included anxiety depression. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) taken for 15 years (2006) and ongoing for anxiety depression. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced some expected injection site soreness. On Friday evening 16Apr2021, the patient broke out in hives and rash that continued to get worse. The patient described the hives started on right side of neck and now is on her face on the right side and neck, on left breast and right lower abdomen which spread around the back down on the leg and on the left bikini line on the groin. She stated now it is like shingles type blistering, weeping, oozing and kind of on fire type of feeling. It is mostly on the right side and there are some spots on the left. When clothes touching it hurts, it is very uncomfortable. She had a friend/physician to call in for her for oral steroids but don't seem to be doing much. The patient clarified the oral steroids as a MEDROL Dose pack, methylprednisolone 4mg tablets, and she only one full-day worth so far, she took all 6 tablets for yesterday (19Apr2021) and has taken one tablet so far today with doses being titrate down daily. It is not any worse than yesterday, but it has not started getting any better either. The patient stated that she has nothing on the left arm where she got the injection, no rash on left arm. Her second dose is scheduled 05May2021 and she does not know if she should get it. The clinical outcome of the event injection site soreness was resolved on 16Apr2021 while the events "hives and a rash that continues to get worse", "shingles type blistering, weeping, oozing and kind of on fire type of feeling" and "When clothes touching it hurts, it is very uncomfortable" were not resolved.; Sender's Comments: Based on temporal association, a contributory role of BNT162b2 to the events of broke out in hives and rash, blistering, weeping, oozing and kind of on fire type of feeling cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-05-04 numbness, tingling Pins and Needles feeling down right arm and then numbness of hand. This began immediately after inj... Read more
Pins and Needles feeling down right arm and then numbness of hand. This began immediately after injection and lasted for 24 hours. Could not use right hand to write it type.
40 2021-05-04 tingling the patient complained of face tingling and sensation of tongue swelling a few minutes after receivi... Read more
the patient complained of face tingling and sensation of tongue swelling a few minutes after receiving vaccine. Her tongue did not appear swollen, she had no shortness of breath. Her symptoms resolved after an additional 30 minutes of observation and she was discharged to home. She did not require medical intervention.
40 2021-05-05 feeling hot About 13 hours after getting my second shot, I began feeling very lethargic, tired, achy, and sore. ... Read more
About 13 hours after getting my second shot, I began feeling very lethargic, tired, achy, and sore. I got the chills and then felt hot. This continued through the night. In the morning I couldn't get out of bed. By about noon the following day (26 hours post vaccine), I began feeling better. By 5pm, I was much improved. By late evening and the next morning, I was back to normal.
40 2021-05-06 feeling hot I received my shot at approximately 12:25. Within 5 minutes of my shot I started to feel a bit light... Read more
I received my shot at approximately 12:25. Within 5 minutes of my shot I started to feel a bit light headed, hot, having difficulty breathing with my mask on (so I pulled my mask down which helped) and then my heart started racing! After grabbing the attention of the nurses, drinking some water and doing some calming breathing exercises my heart rate went down but not to resting. Upon further investigation through my Apple Watch Heart App, my heart rate had spiked to 141 within those first 5-7 mins of the vaccine. Monitoring myself closely over the next couple of days, my heart rate would have little spikes randomly. I?d be sitting (should be at resting heart rate of 65-70) and I?d spike into the 90?s or 80?s for a few moments then return. The first day it happened about every 20-30 minutes for 3 hours, then tapered off to once every hour or so then the next day every hour or two. By Monday April 26th I felt completely normal and have had no other concerns at this time.
40 2021-05-06 tingling, feeling hot, feeling of insects crawling on skin The patient began to feel like there were ants crawling on their skin. It begain in the arm that re... Read more
The patient began to feel like there were ants crawling on their skin. It begain in the arm that received the injection. She then began to feel very hot and a lot of nausea. She then felt like she was going to throw up. Pt did not throw up. Pt sat down longer and the tingling began to subside. She was still feeling nausea and was hot. She got a dry mouth and her mouth felt very hot. We provided her with some water to help with her dry mouth. We also asked the patient if she wanted some benadryl and she said yes. Patient refused an ambulance and was going to have someone at home with her.
40 2021-05-09 pain in extremity Pain/itching behind right arm/shoulder two days later; 6 days later rash appeared on right chest; 8 ... Read more
Pain/itching behind right arm/shoulder two days later; 6 days later rash appeared on right chest; 8 days later diagnosed with shingles
40 2021-05-09 pain in extremity First day, arm soreness. Second day (today), constant diarrhea (about once an hour on empty stomach,... Read more
First day, arm soreness. Second day (today), constant diarrhea (about once an hour on empty stomach, water consistency, large quantity from 9am to 3pm so far and showing no signs of slowing down), nausea, lethargy, itching on left arm. No fever. Nothing life threatening (*knock on wood*). Didn't see this listed on the website's side effects, so I am filling out this form.
40 2021-05-09 tingling Lip swelled slightly and felt tingly a few hours after the shot (5ish hours). Took benadryl and seem... Read more
Lip swelled slightly and felt tingly a few hours after the shot (5ish hours). Took benadryl and seems to have improved mostly but not 100% (still same day as shot)
40 2021-05-09 tremor, feeling of body temperature change Severe flu like symptoms. Body hurts to even touch from head to toes, uncontrollable shaking/shiveri... Read more
Severe flu like symptoms. Body hurts to even touch from head to toes, uncontrollable shaking/shivering, freezing hold or suffocating hot, eyeballs keep loosing focus, feeling like I'm having a anxiety or panic attack, short of breath. First day I felt fine, next day I woke up feeling like I was hit by a car and second day after I'm feeling all the symptoms listed above on a scale of 1-10 I'm at a 10 for discomfort
40 2021-05-10 numbness, flushing within about 10 minutes she experienced flushing and numbness to her Right cheek. She states it spre... Read more
within about 10 minutes she experienced flushing and numbness to her Right cheek. She states it spread to her neck. She opened her window to cool off. The symptoms progressed to a globus sensation of 'a marble in my throat'. She states she was breathing OK, could swallow and tried sips of fluid. EMS saw her, BP was OK, they inspected oral airway. EMS thought she was safe to drive to ER. Once at ER, she started coughing and throat clearing,. ER brought her right in and gave her an epipen. She states within minutes symptoms dissipated and were gone in about 5 minutes. She had no recurrence. She denies pruritis, urticaria, dyspnea, red/watery eyes, face /lip/tongue swelling, CP, n/v/d ER documentation diagnosed allergy to vaccine. Treated her with epipen, famotidine, benadryl and solumedrol. VS and exam were documented as WNL
40 2021-05-10 numbness, cold extremities Sweating, paleness, cold extremities, increased HR, reported temporary numbness in arms and legs
40 2021-05-10 pain in extremity Cough Shortness of Breath Sore throat NAUSEA HEADACHE WHEEZING
40 2021-05-10 tingling Pt received the second dose of Pfizer BioNTech Covid 19 Vaccine (exp. 8/2021) at 1132. At 1202, pati... Read more
Pt received the second dose of Pfizer BioNTech Covid 19 Vaccine (exp. 8/2021) at 1132. At 1202, patient reported swelling and tingling on right cheek. Patient denied itchiness, rashes, hives, and difficulty breathing/swallowing/talking. Patient reported similar reaction to penicillin, no current medications and a heart murmur since she was a child. EMT assessed patient vital: blood pressure 140/60 mmHg, heart rate 106 bpm, and SpO2 98%. Patient given water. Patient tolerated drinking water. Patient offered oral diphenhydramine. Lead Nurse administered 2 doses of 25 mg/10 ml oral diphenhydramine at 1209. At 1214, vitals reassessed: blood pressure (unable to obtain due to unreliable blood pressure cuff, heart rate 98 bpm, SpO2 97%, and patient reported decreased swelling. At 1228, vitals reassessed: blood pressure (unable to obtain due to unreliable blood pressure cuff, heart rate 94 bpm, SpO2 98%, and patient reported decreased swelling. At 1233, patient reassessed. Patient reported swelling and tingling on right cheek "went away". Lead nurse educated patient on signs/symptoms of when to seek emergency care, to see an allergist, follow up with primary care provider about reaction to vaccine, and how to sign up on v-safe. Patient left facility with husband at 1235. Patient left facility with unlabored respirations and steady gait.
40 2021-05-11 feeling cold I had the usual symptoms the first day after, fever/chills etc. It?s now a week later and I have had... Read more
I had the usual symptoms the first day after, fever/chills etc. It?s now a week later and I have had heart palpitations for 4-5 days, blurred vision and an urgency to urinate. I have felt faintish as well. I am hoping this passes soon.
40 2021-05-11 feeling hot, tingling Light-headedness, "adrenaline"-type rush; warm and tingling sensation on right side of face; pulsin... Read more
Light-headedness, "adrenaline"-type rush; warm and tingling sensation on right side of face; pulsing sensation at injection site. Occurred about ten minutes after injection. Intensity greatly diminished after about ten minutes, but slight light-headness lasted for about 45 min- 1 hour.
40 2021-05-11 flushing scratchy throat; flushed feeling; beginning of hives (raised welts); This is a spontaneous report fr... Read more
scratchy throat; flushed feeling; beginning of hives (raised welts); This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 28Jan2021 14:00 (Batch/Lot number was not reported) as single dose at the age of 40-year-old for COVID-19 immunisation . Medical history included congenital heart defects, Eegs allergy. The patient's concomitant medications in two weeks were none. Patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID-19. The patient previously took phenergan, demerol and hydrocodone and experienced drug hypersensitivity. No other vaccine in four weeks. Within 5-10 minutes the patient experienced scratchy throat, flushed feeling and beginning of hives on 28Jan2021 02:15. Patient received treatment with Benadryl for the events. COVID was not tested post vaccination. The outcome of events was recovered in 2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
40 2021-05-11 pain in extremity, burning sensation It seemed like the second dose was higher on my right arm than the first dose. When it was given, it... Read more
It seemed like the second dose was higher on my right arm than the first dose. When it was given, it hurt a lot and there was a burning sensation. My right arm hurt a lot immediatetly afterward and the pain was severe for the first couple of days after the second dose. The pain decreased but was still there, mainly when lifting my right arm. The pain gets worse the higher I lift my right arm. It has been over three weeks and there is no improvement. The pain is mild and I can still move my arm, but it is very annoying.
40 2021-05-11 pain in extremity It started out as extreme arm pain which turned into shoulder pain that still hasn't gone away. I ca... Read more
It started out as extreme arm pain which turned into shoulder pain that still hasn't gone away. I can barely lift my arm some days and it just isn't getting better. The pain got so constant it made it impossible to sleep which has caused me to start having a round of panic attacks.
40 2021-05-11 tremor Customer c/o uncontrollable shaking after taking the second dose. At customer was leaving the park ... Read more
Customer c/o uncontrollable shaking after taking the second dose. At customer was leaving the park at check point one customer pulled over to report shaking to staff. EMS and nurse responded to call. BP 149/82, HR 74, O2 99 and glucose 96.
40 2021-05-12 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
40 2021-05-13 cold sweat Per recovery RN notes: 05/10/2021 1026 AM Patient Female Vaccine Time: 1018 Symptoms: Patient state... Read more
Per recovery RN notes: 05/10/2021 1026 AM Patient Female Vaccine Time: 1018 Symptoms: Patient stated, " I don't feel well I feel clammy". Intervention: RN had patient sit on floor, VS taken BP 95/59. Right arm lying down, HR 62, RR12, 02sat 100%. RN had patient lay down and after about 10-14 minutes patient reported she felt better and could sit up in chair. Patient rested for another 10 minutes and reported she felt well enough to leave.
40 2021-05-13 discomfort 5 days after i received the first Pfizer vaccine my stomach began to hurt and i get as if I had a UT... Read more
5 days after i received the first Pfizer vaccine my stomach began to hurt and i get as if I had a UTI. I went to urgent care where i was tested and everything came back negative. Within the next few days my stomach began to bloat and i became quite constipated. Along with this, my stomach was in so much aching pain and i felt like i had to pee (like a UTI). Again, went to the doctor and was told i had no UTI. The next day it was unbearable....the pain and uncomfortableness, so i went to the ER. They ran tests and everything looked clear. Went home and suffered with this pain, bloat, constipation, pressure to pee. Throughout the past month i have seen a GI doctor, Urologist, and gynecologist. Everything looks clear and good and no one has any idea what has happened to me. I was perfectly healthy before the immunization. I believe the immunization inflamed my GI system, and Bladder. Slowly things are returning to normal but I know this had to have been caused by something.
40 2021-05-13 discomfort Sever hip and lower back pain requiring tele visit with who then sent me to urgent care. Sever pain... Read more
Sever hip and lower back pain requiring tele visit with who then sent me to urgent care. Sever pain and discomfort lasted for 6 days straight with no relief from NSAIDS, heat, or ice, or muscle relaxers. Pain persisted non stop for 6 days and was excruciating. For females viewing this, worse than back labor that wouldn?t stop. Urgent care informed me joint pain was from vaccine.
40 2021-05-13 feeling hot, burning sensation, slow speech, cold sweat, tingling I walked down a very short flight of stairs to take laundry out of the dryer. My heart started racin... Read more
I walked down a very short flight of stairs to take laundry out of the dryer. My heart started racing and I began to sweat uncontrollably. My hands and feet became clammy. I became very hot and thirsty and distressed. My hands and feet were very clammy and I had to sit down and take deep breaths. I drank two water bottles of water and poured some on me to cool off. My breathing was compromised and I was taking gulps of air. I became slower in movement and responses and too disoriented to drive. I asked my boyfriend to give me a ride to the ER. I went through intake and was later given an EKG, IV for bloodwork and Chest X-ray. Symptoms: Nausea, palpitations, heart racing, muscle aches, chills, sudden sweating, clammy hands and feet, extreme thirst, difficulty breathing, slowed responses, slowed speech, burning tingling from top of neck down to left arm.
40 2021-05-13 hot flush About 8 or 10 hours later, I woke up during the night with severe chills and a fever. I was taking T... Read more
About 8 or 10 hours later, I woke up during the night with severe chills and a fever. I was taking Tylenol every four hours, but it wasn't helping at all. I was also nauseous. All of that lasted for about 21 hours, then they decreased and lasted like another day. I was having hot flashes. My left knee randomly gave out a few weeks after that and my left armpit was really itchy. It was the sickest I've felt in my entire life. I spoke with my doctor and she prescribed nausea meds.
40 2021-05-13 pain in extremity anxiety; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 va... Read more
anxiety; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine; mental problem; so sick; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. Medical history included bipolar from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Mar2021, the patient experienced sleepiness. On an unspecified date, the patient experienced anxiety, they felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine, mental problem, so sick. She had really serious problem, had to leave work and go to the hospital and get treated for anxiety in the emergency room. Causing her anxiety to go crazy. After taking the Vistaril yesterday it calmed the girlfriend down. Outcome of events anxiety, felt soreness in the arm, mental problem, so sick was unknown. Outcome of Sleepiness was recovered in 2021. No follow-up attempts are needed. No further information is expected.
40 2021-05-13 tingling, feeling cold, numbness Immediately upon receiving the first injection of the two part series, I felt coldness running down ... Read more
Immediately upon receiving the first injection of the two part series, I felt coldness running down my left arm as if I was getting an IV and then tingling and numbness in my left thumb. The numbness and tingling remained for approximately 5 to 8 hours that day. Additionally immediately upon receiving my second dose in the series on April 26, 2011 at 9:20 AM I felt both my left and right arms and hands go numb after approximately 45 minutes I felt numbness in my left cheek and upper left and lower lips. The numbness remain for approximately four hours with full resolution by eight hours later.
40 2021-05-14 discomfort, cold sweat 10:25 AM. Patient was in Observation Area post vaccination 2nd dose of Pfizer. Suddenly, she compla... Read more
10:25 AM. Patient was in Observation Area post vaccination 2nd dose of Pfizer. Suddenly, she complained to RN who was the Observation Nurse that she has the pressure in her Left arm radiating to her neck and chest. She looked pale and clammy too. Oxygen saturation was on 83%, HR 93, Temp 97.5. No blood pressure taken due to unavailability of the apparatus at the site. 911 was called and took the patient into their VAn.
40 2021-05-14 feeling of body temperature change Severe Diarrhea, anything I ingest, water, food, is expelled within 25 mins. Severe abdominal crampi... Read more
Severe Diarrhea, anything I ingest, water, food, is expelled within 25 mins. Severe abdominal cramping as well. Hot and cold sweats, extreme lethargy, metalic taste in mouth, cognitive delay, trouble focusing, short term memory recall
40 2021-05-14 pain in extremity, slurring, discomfort, numbness difficulty walking; difficulty with speech / slurred speech; fingers are going numb holding the phon... Read more
difficulty walking; difficulty with speech / slurred speech; fingers are going numb holding the phone; feels like she is coming down with a respiratory illness; nausea; vomiting; cough; sweating; headache; body pain, achy and uncomfortable; body pain, achy and uncomfortable; overall feeling badly; cognition was not there; Problems with breathing; aspirating; sleepiness; fatigue; stomach pain; her nerve response is strong/affected; swelling in hands and feet; had arm soreness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0162), via an unspecified route of administration in the left arm, on 23Apr2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing neuropathy (few years ago, at least since 2015 or 2016), seizures or epilepsy (had focal/absence seizures since a kid; not on any seizure medication, do have a neurologist), hard time with her vision, cancer from an unspecified date to an unspecified date (cancer as a teenager but has been cancer-free for a very long time), and glaucoma. The patient had a family history of cancer and heart problem. Concomitant medications included latanoprost (MANUFACTURER UNKNOWN) taken for glaucoma from Apr2021 and ongoing and gabapentin (MANUFACTURER UNKNOWN) taken for neuropathy from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER8730), intramuscularly in the left arm, on 02Apr2021 for COVID-19 immunisation and experienced not very many side effects with first dose, not enough to be a problem; influenza vaccine (MANUFACTURER UNKNOWN) in 2021 (maybe) for immunisation; and polio vaccine (MANUFACTURER UNKNOWN) as a child for immunisation and experienced severe pain in her legs and she had trouble walking because of pain. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced difficulty walking and difficulty with speech / slurred speech on 23Apr2021, which required hospitalization from Apr2021 to 26Apr2021. The patient also experienced body pain, achy and uncomfortable, overall feeling badly, cognition was not there, and problems with breathing on 23Apr2021; sweating and headache on 26Apr2021; vomiting and cough on 27Apr2021; feels like she is coming down with a respiratory illness and nausea on 28Apr2021; sleepiness, fatigue, stomach pain, her nerve response is strong/affected, swelling in hands and feet, aspirating, and had arm soreness in Apr2021; and fingers are going numb holding the phone on 29Apr2021. The clinical course was reported as follows: The patient stated that she works in healthcare support and she is a first responder; she identifies as a person with a disability (unspecified). She stated that she did not have very many side effects with first dose, not enough to be a problem. By dinnertime, closer to 18:00-19:00 on 23Apr2021, she started experiencing difficulty walking and with her speech. She was concerned about having a stroke but that she is active and generally healthy. This was unusual for her and she started feeling pain through her body and overall feeling like crap. She did not expect the neurological stuff. By the end of the night on 23Apr2021, she realized she was not feeling good and went to the hospital either that night on 23Apr2021 or early the next day on 24Apr2021 and was admitted to the hospital. The patient stated that her cognition was not there, and her speech was kind of slurry, she felt like everything was slowing, and did not feel like herself. She could not get up unassisted, could not get up out of the bed, chair, or go to bathroom, and still requires the use of a walker and bedside commode, but now with the walker and assistance caller can make it to the bathroom. She also had problems with breathing, but she had a negative COVID-19 PCR test in Apr2021 both arriving to and leaving from the hospital; she did not believe them to be COVID-19 symptoms. At the hospital they did an x-ray or computerized tomography (CT) scan and a magnetic resonance imaging (MRI) on her brain in Apr2021 with unknown results. They gave her 3 or 4 intravenous (IV) unspecified medications and she had her complete blood count (CBC) labs done in Apr2021 with unknown results. There was an issue with her lungs, and she is currently waiting for her doctor to read report to see if there is an issue there. The patient stated that she never experienced anything like this after a vaccine. She cannot even get up and move around it is pretty serious. Caller states that at first when she had the symptoms, she thought she was going to wait it out, maybe her immune system is overresponding, give it a chance to resolve. She reported that she could not stand up, legs were shaking and that she had pain that was from her breasts down; felt like a ton of bricks. The patient stated that she is cognitively alert now, speaking normal. There are times it goes in waves where she feels like she can walk with walker but then a few hours later that is not the case. On Tuesday, 27Apr2021 night, the patient had a light dinner but then she was vomiting. Caller states that the pain was throughout her body and felt like someone lighting firecrackers. The patient initially stated 28Apr2021 was when the cough started, but later clarified she first noticed it on 27Apr2021, but at that time she was vomiting and thought it was due to that. However, the next day 28Apr2021, she still had this cough and that the cough was getting worse. She felt like she has a respiratory issue and has been coughing. She was not able to stay awake, even without taking any medications. She does take medications regularly but did not take the medications those days and not having medications would not cause sleepiness. She thought the doctor gave her sedative, but they did not. She states she had fatigue to the point where she was dead asleep, and nurse would come in to take vitals or do whatever and she would wake up suddenly with someone in front of her. She was sitting up with the nurse trying to read the discharge instructions and she fell asleep sitting up. She also complained of stomach pain. The patient had not been to work and not been having to use her brain and talking like she would for 8+ hours a day. She stated that the cough hurts, it feels like somebody is lighting firecrackers in her body. It also feels like this when she sneezes; the nerve response is strong. She reported that it is not a constant hacking cough, not really a dry cough; the cough is in-between productive and dry cough and cough is a bit better now and worse towards the evening. She still has swelling in her feet and hands. It looks like it has gone down a bit. She has a history of neuropathy and that her fingers are going numb holding the phone now. She got the shot in her left arm and those fingers are going numb. She was so tired and feels like did not get enough sleep. The fatigue had a slight improvement. She is more awake than when she was in the hospital. However, it depends as the day goes on, she is wiped out and has to go lay down. She stated that her nerve response is affected, and she had a difficult time with the neuro exam in Apr2021 with unknown results in the hospital. She was having an issue with her arms. She can't say anything about whether it affected her vision because she already has a hard time with her vision. She stated that she was throwing up pretty bad; the pain was really severe through her whole body while vomiting. After the vomiting stopped, the coughing got worse and she was coughing a little bit before the vomiting, but during the vomiting it was to the point she felt like she was drowning. She reported that she was vomiting through her nose and aspirating. After her MRI she started to get a really bad headache. Then when the nurse was coming to read the discharge information, she started to get sweats. She is not menopausal so she cannot blame the sweating on menopause, as reported. The patient also had arm soreness, but does not care about that long as it does not leave any scars. This was not a big deal for her at all. This started shortly after getting the vaccine. She waited for the observation time and no sensation out of the normal, then later towards the night started feeling like having really bad mensural cramps, like an achy feeling where have to go lie down. Then her lower half started to get worse. Her arms were affected and difficult time with the neuro testing. The patient stated she is now on the road to recovery. The clinical outcome of difficulty walking, difficulty with speech / slurred speech, body pain, achy and uncomfortable, nausea, sleepiness, fatigue, and stomach pain was recovering and of overall feeling badly, cognition was not there, problems with breathing, sweating, headache, vomiting, cough, feels like she is coming down with a respiratory illness, her nerve response is strong/affected, swelling in hands and feet, aspirating, had arm soreness, and fingers are going numb holding the phone was unknown.
40 2021-05-14 pain in extremity About 24 hours after my second shot severe pain in back an lower extremities. Lasted at the severe l... Read more
About 24 hours after my second shot severe pain in back an lower extremities. Lasted at the severe level for about 12 hours. Mild pain continued for 2 weeks like sciatica nerve pain in both legs. 2 and a half weeks later pinched nerve in back . L5 to S1. Disc degeneration found but unexplained why the pain started at time of shot.
40 2021-05-14 pain in extremity then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the wo... Read more
then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the worst was behind my eyes deep in sockets; Sharp pain both arms 1 min.; left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Apr2021 at 11:15 (at the age of 40-years-old) as 1st dose, single for COVID-19 immunisation. Medical history was reported as yes but not specified. The patient's concomitant medications were not reported. On 30Apr2021 at 11:15, the patient experienced sharp pain both arms for 1 minute then itch was mild for 1 hour. Started itching all over the worst was behind her eyes deep in sockets that lasted 2 days, had to take diphenhydramine (BENADRYL). Left arm was swollen that night and lasted 2 days. On day 3, she was still itching but not as bad. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
40 2021-05-14 tingling high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hand... Read more
high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hands and feet; Memory loss; experienced early period with clotting which stopped in 2-3 days then started faint spotting; Throat closure sensations; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 03Apr2021 (Batch/Lot Number: Er8734) as single dose at the age of 40-year-old for covid-19 immunisation. Medical history included allergy to amoxicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date the patient experienced early period with clotting which stopped in 2-3 days then started faint spotting again a day later, high blood pressure, cold sore, dizzy / lightheaded, vision is blurry, chest pains, tingling in hands and feet, memory loss. On 03Apr2021 18:00 the patient experienced throat closure sensations. The course of events was as follows: Throat closure sensations, high blood pressure, chest pains, cold sore, dizzy / lightheaded, early period with clotting which stopped in 2-3 days then started faint spotting again a day later. After 25 days, I am still dizzy and have tingling in hands and feet. Memory loss, and vision is blurry. The adverse events resulted in Doctor visit, Emergency room/department or urgent care. The events early period with clotting and started faint spotting again a day later, throat closure sensations were considered medically significant. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.
40 2021-05-15 muscle spasms Muscle cramping in calves up to one month after 2nd shot; Muscle fatigue in arms and legs to this da... Read more
Muscle cramping in calves up to one month after 2nd shot; Muscle fatigue in arms and legs to this date (6 weeks after 2nd shot)
40 2021-05-15 pain in extremity Pain in arm - realized when I woke up the morning after taking the shot. Pain continued through the ... Read more
Pain in arm - realized when I woke up the morning after taking the shot. Pain continued through the day, then waned to milder the next morning. Fatigue - lasted a few hours during the late morning of the day after the vaccine. Accompanied by a little chill. No fever. This was my second vaccine. No adverse events upon receiving my first dose.
40 2021-05-16 weakness Loss of energy, upset stomach.
40 2021-05-16 cold sweat, pain in extremity, nerve pain, feeling cold Sharp nerve type pain in left arm that has moved up to left shoulder blade and into the spinal area ... Read more
Sharp nerve type pain in left arm that has moved up to left shoulder blade and into the spinal area in between my shoulder blades. The pain causes a cold ice pick feeling. It?s hard to turn my head to the left. I had arm soreness since injection with headache that lasted until yesterday late, nausea, fatigue, chills all over and achy body. These pains in my shoulder, neck and back started this morning when I woke up. I did wake up around 4am with cold sweats that actually caused me to sweat through my clothes and hair. This new pain is severe.
40 2021-05-16 electric shock sensation, feeling hot Hot, itching ears outside and inside starting at 4:00pm. Followed by itchy mouth, racing heart, and ... Read more
Hot, itching ears outside and inside starting at 4:00pm. Followed by itchy mouth, racing heart, and all over skin itching. I took an extra Claritin at about 4:15. Then around 5pm I had a sudden feeling of an allover body sensation like a surge of electricity or drop in blood pressure, and had ringing in my ears and slowing of thoughts and movement and awareness. Went to the ER. Still itchy and ears were red. About 2 hours later all itching was gone and ears were no longer red. Stayed at the ER until 7:40pm.
40 2021-05-16 migraine Increase in frequency and severity of migraines starting one week after 2nd dose and has lasted for ... Read more
Increase in frequency and severity of migraines starting one week after 2nd dose and has lasted for over 6 weeks
40 2021-05-16 muscle twitching Facial twitching on the left side of my face above the lip.
40 2021-05-16 pain in extremity Since receiving the second dose of CoVid vaccine, my left are has not stopped hurting. It is not con... Read more
Since receiving the second dose of CoVid vaccine, my left are has not stopped hurting. It is not continuous, however it has been significant enough to distract me for my daily task. It gets worse at night, especially when I am sleeping. My functionality of that arm has been negatively affected as well. I am not able to comfortably lift the arm sideways as high and not able to lift heavy objects as well.
40 2021-05-16 pain in extremity A few hours after patient received vaccine, she felt pain in her arm, swelling and redness. She iced... Read more
A few hours after patient received vaccine, she felt pain in her arm, swelling and redness. She iced her arm. She had swelling in her arm for 2 days. Pain lasted for 3 days. She took some Tylenol to help with the pain the second day. She is worried about the abnormal marking on her arm that has not gone away yet.
40 2021-05-17 facial pain, pain in extremity, breast pain Sharp pain up and down left side of body. This was experienced after both the first and second dose... Read more
Sharp pain up and down left side of body. This was experienced after both the first and second dose of the vaccine.
40 2021-05-17 pain in extremity, tingling Extreme fatigue (falling asleep sitting still), headache, sore arm. Fatigue was equivalent to that w... Read more
Extreme fatigue (falling asleep sitting still), headache, sore arm. Fatigue was equivalent to that when actually having the flu. Extreme difficulty staying awake, ended up falling asleep mid-sentence while sitting on the couch. After nap, low-level fatigue and sleepiness remained. Would not consider self safe to drive. Mild headache, responded well to over the counter medication (ibuprofen and acetaminophen). Arm soreness began earlier (immediately after vaccination) and increased in stiffness and soreness with reducing range of motion over time. Pain medication helps but still very sore. Pain seems to be affecting a nerve, as tingling radiates down the arm to the little finger in the hand, and all along the side of the arm.
40 2021-05-18 discomfort A few days after receiving the first dose my knees started hurting as soon as I bent them. The sympt... Read more
A few days after receiving the first dose my knees started hurting as soon as I bent them. The symptoms have increased since then at first I thought it would go away and thought that maybe I just somehow hurt myself. However, after I received the second dose the pain has intensified I now can't sleep from the joint pain on my knees and it feels like there is something pressing on the back of my knees and the stiffness is terrible. I do not have great health insurance, thus I have been putting off seeing a doctor. Yet, after last nights pain I have made an appointment and hope see one in July since there are no appointments available sooner.
40 2021-05-19 flushing Found out I was pregnant day after shot week later I was bleeding for 3 days kind of like a period t... Read more
Found out I was pregnant day after shot week later I was bleeding for 3 days kind of like a period then it stopped on the 25 I started having high fevers chills facial flushing went to walk in clinic on 27 said I have strep throat took antibiotics 5 days in still having fever chills flushing went to primary dr did blood work showed I had infection blood pressure started becoming high went to obgyn pregnancy hormone low was told not a good pregnancy on 5/14 went to have pregnancy terminated blood pressure very high on 5/17 back at primary dr with high fever chills facial flushing again blood pressure still high put on a water pill to control blood pressure went back to obgyn everything good from procedure hormone levels almost back to zero
40 2021-05-20 burning sensation, muscle spasms, pain in extremity, tingling, cold extremities I woke up about 12 hours after my shot with leg pain (2:30am on Saturday. It came and went over the ... Read more
I woke up about 12 hours after my shot with leg pain (2:30am on Saturday. It came and went over the course of a few days and then was gone for maybe a day or so. It returned on Tuesday and continued to worsen and spread some. I was seen and had an elevated d-dimer test. They did an ultrasound for blood clots. Currently, I'm on day 7 and have aching, cramping, tingling, burning and cool sensations in both legs and a bit in my arms.
40 2021-05-20 migraine PT REPORTED MIGRANE LIKE HEADACHE WITH OUT AURA SHE ALSO REPORTED SOME DIZZINESS WE ADVISED HER TO L... Read more
PT REPORTED MIGRANE LIKE HEADACHE WITH OUT AURA SHE ALSO REPORTED SOME DIZZINESS WE ADVISED HER TO LIE DSWN AND TO HYDRATE COLD PACK WAS PROVIDED, PT REPRTED THAT SHE WILL TAKE TYLON AFTER LEAVING OBSERVATION, SHE WAS IN OBSERVATION FOR APPROX 30 MIN
40 2021-05-20 muscle spasms My first period after the shot is the worst of my life. More blood, darker blood, clots. Intense cra... Read more
My first period after the shot is the worst of my life. More blood, darker blood, clots. Intense cramps. Serious, heavy bleeding.
40 2021-05-20 muscle twitching Muscle twitching in legs
40 2021-05-21 burning sensation broke out in canker sores all over mouth again; Slept 17 hours q day; severe fatigue; Sinus and ear ... Read more
broke out in canker sores all over mouth again; Slept 17 hours q day; severe fatigue; Sinus and ear pressure; Sinus and ear pressure; Generalized aching; break out in canker sores all over my mouth; sore muscles all over; joint pain; mild itching to upper torso, breasts and under arms; low grade fever; chills; face became pink and warm; felt burning sensation throughout my body; This is a spontaneous report from a contactable nurse (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid left on 03Feb2021 12:00 (Batch/Lot number was not reported) as 1st dose, single at age of 40-years-old for covid-19 immunization. Medical history included Asthma, 3 herniated discs in neck, hx of pneumonia, hypertension (HTN). Known allergies included: Ceclor, PCN, Doxycycline, Bactrim DS, Codiene, berries and anaphylaxis to Latex. Concomitant medications the patient received within 2 weeks of vaccination included: lisinopril; hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event started on 03Feb2021 14:00 PM, within first 24 hours the patient experienced mild itching to upper torso, breasts and under arms, also had low grade fever and chills in this time. Within first 24 hours, face became pink and warm, and felt burning sensation throughout her body. At this point the patient took Pepcid and Benedryl and it seemed to control symptoms. On 09Feb2021, the patient begun to break out in canker sores all over her mouth, total of 5 (the patient did not have a canker sore since high school), began to develop sore muscles all over and joint pain that progressed to severe by 12Feb2021. Worse in mornings. Got a flu and covid test (Nasal Swab). They were negative. 17Feb-20Feb2021 severe fatigue and cont. Joint pain. Slept 17 hours q day. Sinus and ear pressure. Generalized aching. The patient did not get 2nd vaccine. 01Mar2021 broke out in canker sores all over mouth again. Took 4 days to resolve. The patient was still having significant joint pain throughout her body, worse in mornings. The patient never had this before vaccine. Events resulted in disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event canker sores was recovered, of other events was not recovered. Follow up needed, further information has been requested.; Sender's Comments: "Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded" The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-05-21 migraine Severe migraines for two weeks which persist for night and day.did not go away after many forms of o... Read more
Severe migraines for two weeks which persist for night and day.did not go away after many forms of opioids; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 08:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient has no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks of vaccination. The patient previously took metronidazole (FLAGYL [METRONIDAZOLE]) and experienced allergies. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 08:00 in the left arm for covid-19 immunization. On 28Apr2021 17:00, the patient experienced severe migraines for two weeks which persist for night and day. This did not go away after many forms of opioids were taken, only subsided after steroids. The patient never had a history of headaches or migraines. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with opioids, muscle relaxers, and steroids. The outcome of the event was recovering. Information on the batch/lot number has been requested.
40 2021-05-21 muscle spasms I was 7 weeks pregnant and received 2nd Pfizer vaccine, on the same day started having virginal blee... Read more
I was 7 weeks pregnant and received 2nd Pfizer vaccine, on the same day started having virginal bleeding and crumping, had miscarriage next day.
40 2021-05-21 pain in extremity Dark bruise (larger than a golf ball) at injection site. A few hours after the shot, extreme sorenes... Read more
Dark bruise (larger than a golf ball) at injection site. A few hours after the shot, extreme soreness in arm to the point of being unable to lift for 24 hours after the injection. Extreme muscle ache, skin aches and extreme fatigue for almost two full days after receiving shot.
40 2021-05-22 burning sensation, pain in extremity Right after vaccine injection site was extremely itchy. After a few minutes of vaccine my whole body... Read more
Right after vaccine injection site was extremely itchy. After a few minutes of vaccine my whole body was itchy . Left arm was extremely sore warm to touch and bruised 45 minutes after vaccine I bleed as if I was getting my period (Bright red blood) spotted until the next day then it was done. I was due for my menstrual cycle on 05/22/2021 which never came I am regular on my cycle. Topical rash on neck developed after 24hrs , redness, itching and burning
40 2021-05-22 pain in extremity, discomfort slight discomfort including muscle pain, arm pain, soreness, tiredness
40 2021-05-22 pain in extremity Both right and left middle fingers got swollen. Both right and left middle fingers are painful to m... Read more
Both right and left middle fingers got swollen. Both right and left middle fingers are painful to move. Both right and left middle fingers feel as if they have a tight ring on them, but there is no ring on them. Sometimes the pain goes to the palm of my hands. I have had these symptoms for two moths now.
40 2021-05-23 slurring, slow speech, tingling Potential stroke: slurring of words, brain glitch in a sense. I had the words in my head but it was... Read more
Potential stroke: slurring of words, brain glitch in a sense. I had the words in my head but it was all coming to me slowly and and I could only speak one word at a time slowly and empahtically to not slur again. Head was in pain and my entire body was tingly for about 20m. The initial onset and glitch only lasted a few seconds. I had seen primary care physician and she has scheduled tests. I was told not to get the 2nd dose and to seek emergency help if it happens again. Possible permanent damage but unknown.
40 2021-05-23 slurring Blood oxygen level dropped rapidly to 86 about 30min after shot. Caused a feeling of hypoxia and slu... Read more
Blood oxygen level dropped rapidly to 86 about 30min after shot. Caused a feeling of hypoxia and slurred speech.
40 2021-05-23 facial paralysis, bell's palsy I started to have headaches which continued until 05/20/2021 and Ultimately had a fever (100.6) at 1... Read more
I started to have headaches which continued until 05/20/2021 and Ultimately had a fever (100.6) at 10:30 pm with chills. Tylenol and Advil were taken throughout the process. On 05/21/2021 at 09:45 am, I noticed the droopyness to my left side of the face. I tested negative for Covid-19 at 11:00 am. On the same date at 11:30 am I met with my PCP who suggested that I go to the Emergency room. At 12:30 I went to the Hospital and was treated for Bell's Palsy. I have been taking Prednisone (20mg) 3x a day and Valacyclovir (1Gm) 3x a day.
40 2021-05-23 tremor Headache reported following administration. However, on 5/8 patient reported she had shaking chills,... Read more
Headache reported following administration. However, on 5/8 patient reported she had shaking chills, dizzy, fatigue- passed out twice in husbands presence. No fever.
40 2021-05-24 bell's palsy Bell's palsy at right of the face
40 2021-05-24 numbness, tingling About 20 minute after vaccine was administered I felt a subtle numbness feeling to the right of my m... Read more
About 20 minute after vaccine was administered I felt a subtle numbness feeling to the right of my mouth. Then it was felt on most of my right cheek. It lasted the whole day and the next morning it was mostly gone. Since then my right eyelid and under eye have been a little red which isn't normal for me. Some tingling in right leg felt as well. Mainly concerned about the face sensation and not sure if I should proceed with second shot.
40 2021-05-24 numbness Two weeks after the first Pfizer shot, I experienced labored breathing, congestion, fluid around my ... Read more
Two weeks after the first Pfizer shot, I experienced labored breathing, congestion, fluid around my heart and left side numbness and stabbing head pain.
40 2021-05-24 muscle spasms Menstrual period delayed by 8 days. Heavy PMS symptoms including breast tenderness, irritability, he... Read more
Menstrual period delayed by 8 days. Heavy PMS symptoms including breast tenderness, irritability, headache, cramping and bloating lasting for 10 days accompanied by a heavier than usual menstrual period but lasting a shorter amount of time than typically experienced previously (typical period is about 5-6 days long, this period was only 4 days in duration). Worth noting the reason I was hyper aware that my period was late is 1) it has never been late in my entire life and I am 41 years old. 2) I use an app to track my cycle and it kept alerting me that it was late. I am on birth control and knew that I was not pregnant, however, it caused distress because I didn't know what was wrong with me and no one wants to have severe PMS for 10 days with no relief in sight.
40 2021-05-24 pain in extremity Fever of 100.8-100.9 the next day.; Fatigue; Arm soreness; This is a spontaneous report from a conta... Read more
Fever of 100.8-100.9 the next day.; Fatigue; Arm soreness; This is a spontaneous report from a contactable other healthcare professional. A 40-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via intramuscular route of administration on 28Jan2021 (Lot Number EL3247), 13:30 in right arm (age at vaccination: 40 years) as, single for COVID-19 immunization. The patient medical history included allergic to drug included bactrim. Concomitant medications included fish oil, gotu kola [centella asiatica] (GOTU KOLA [CENTELLA ASIATICA]), bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) and multivitamins; all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination and post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via intramuscular route of administration on 07Jan2021, 13:30 in left arm (age at vaccination: 40 years) as, single for COVID-19 immunization. On next day (i.e. 29Jan2021) at 09:00, the patient developed fever of 100.8-100.9, fatigue and arm soreness for which the patient did not received any treatment. The events were assessed as non-serious. The patient underwent lab tests and procedures which included body temperature: 100.8-100.9 on 29Jan2021. The outcome for all the events was unknown. Follow-up attempts are completed. No further information is expected.
40 2021-05-24 tingling pt felt dizzy with tingling in left arm. given water and additional observation.
40 2021-05-24 speech disorder, numbness, tingling, cold extremities Severe chills; Joint pain; Severe Headache; Stomach Ache; Cold feet/ Cold hands; Forgetfulness; Mumb... Read more
Severe chills; Joint pain; Severe Headache; Stomach Ache; Cold feet/ Cold hands; Forgetfulness; Mumbled speech; Numbness; Tingling all over; Difficulty focusing; Body Aches; Fatigue, Tiredness; Foggy head; This is a spontaneous report from a contactable other hcp (Nurse). A 40-years-old female non pregnant patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number was EL0142), intramuscular, administered in Arm Left on 28Jan2021 at 08:00 as 2nd dose, single for COVID-19 immunization. Historical vaccine of bnt162b2 as first dose (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm right on 08Jan2021 at 03:00 PM (Batch/Lot Number was EL0140) as first dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No allergies were found. Patient was not pregnant at the time of vaccination. Patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 28Jan2021 at 17:00 patient experienced severe chills, joint pain, severe headache, stomachache, cold feet/ cold hands, forgetfulness, mumbled speech, numbness, tingling all over of, difficulty focusing, body aches, fatigue, tiredness and foggy head. No treatment was received. The outcome of the events was recovering. Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
40 2021-05-25 weakness I was sick for four days with: fever, headache, body aches, sweating, nauseous, in so much pain and ... Read more
I was sick for four days with: fever, headache, body aches, sweating, nauseous, in so much pain and no energy I could barely move. Lastly, was clear odorless liquid coming out of my vagina. The last symptom lasted for a full week.
40 2021-05-25 weakness weakness generalized; . This is a spontaneous report from a non contactable other h... Read more
weakness generalized; . This is a spontaneous report from a non contactable other health care professional, the patient. A 40 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration, and anatomical site as 2nd dose, single, on 16MAR2021 (at the age of 40-years-old) for COVID-19 immunization. Patient past drug history include BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not known) via an unspecified route of administration, anatomical site as 1st dose, single, on unspecified date for COVID-19 immunization. On 16MAR2021 after vaccination, during her 15 minute waiting period after the injection, the patient began to experience generalized weakness, need for a quick snack. She denied rash, shortness of breath, difficulty swallowing or syncope treatment included: snacks. It was reported that follow up response to treatment was good. Patient discharge: stable to go home. Clinical outcome of the event generalized weakness was reported as recovered .No follow-up attempts are possible. No further information is expected.
40 2021-05-25 numbness, tingling, burning sensation Left arm numbness; hand tingling; left jaw pain; Left side of face and scalp began to burn; Internal... Read more
Left arm numbness; hand tingling; left jaw pain; Left side of face and scalp began to burn; Internal tremor of the brain; dizziness; This is a spontaneous report from a contactable consumer reported for herself. A 40-years-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: Er8730 and Expiration date was not reported), via an unspecified route of administration, in right arm (age at vaccination 40-year-old) as 2nd dose, single for covid-19 immunisation and patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: En6208 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 19Mar2021 09:45 AM for covid-19 immunisation. Medical history included hypervitaminosis, migraines, and prior to vaccination, patient was diagnosed with COVID-19. The patient was allergic to Levaquin. Concomitant medications that patient received within 2 weeks of vaccination included ferrous citrate (IRON [FERROUS CITRATE]). Facility where the most recent COVID-19 vaccine was administered in hospital. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Prior to vaccination, patient became now not diagnosed with COVID-19. Patient underwent laboratory test which includes nasal Swab Pcr, covid test on 11May2021 and the result was pending. On 09Apr2021 10:00 the patient experienced left arm numbness 5 minutes after injection, hand tingling, left jaw pain. Left side of face and scalp began to burn one day after injection. Internal tremor of the brain and dizziness. Treatment was received for all event as medical supervision from hospital staff. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
40 2021-05-25 muscle twitching TINNITUS bilateral, loud, persistent Joint soreness Foggy thinking Pain at injection site Headache W... Read more
TINNITUS bilateral, loud, persistent Joint soreness Foggy thinking Pain at injection site Headache Weird twinges all over body randomly
40 2021-05-25 pain in extremity, breast pain Left arm soreness; Soreness on left side of breast as well as right; Lymph nodes enlarged; spotting;... Read more
Left arm soreness; Soreness on left side of breast as well as right; Lymph nodes enlarged; spotting; 1 week early than normal menstrual cycle; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in the left arm on 09Mar2021 12:00 (Batch/Lot Number: Eng205) as SINGLE DOSE for covid-19 immunisation. Patient had no medical history. Concomitant medication included ashwagandha (ASHWAGANDHA) taken for an unspecified indication, start and stop date were not reported. On 11Mar2021, the patient experienced Left arm soreness for 2 days. Soreness on left side of breast as well as right. (Lymph nodes enlarged) spotting noticed 6 days after vax, 1 week early than normal menstrual cycle. The outcome of events was reported as unknown.
40 2021-05-25 pain in extremity After the 1st shot, I had 2.5 weeks of severe fatigue, my femurs deeply ached, and crushing headache... Read more
After the 1st shot, I had 2.5 weeks of severe fatigue, my femurs deeply ached, and crushing headache. after the 2nd shot, I had fatigue but on 1/30/2021 I was woken up by hives. I took Benadryl and they went away. On 1/31/2021 I was woken up by hives again and 4 hours later, my throat began to close up and my stomach was crampy. I went to the ER and rec'd epi, Decadron, & Pepcid to great relief. However 2/1/2021 my throat began to close up again and I went back to the ER and they just gave me Decadron. I now have to see an allergist and take Xyzal 20 mg/day, Pepcid 80 mg/day, and Singulair 10 mg/HS to keep the hives and throat closing from coming back.
40 2021-05-25 tingling I was very tired a few hours after the shot so went to bed a little early. Shortly after, I experie... Read more
I was very tired a few hours after the shot so went to bed a little early. Shortly after, I experienced sharp heart pains (this sometimes happens with my mitral valve prolapse). The sharp pain went up the left side of my neck (not normal with my MVP). The insides of my thighs felt tingly, not painful but not painless either. It almost felt like they were on the verge of throbbing. I?ve never had this before so it?s hard to describe.
40 2021-05-26 feeling cold I became very light headed and passed completely out. I do not remember anything leading up to this ... Read more
I became very light headed and passed completely out. I do not remember anything leading up to this or while it was happening. When I came too, I couldn't hear, had ringing in my ears, couldn't walk on my own, and my husband said I was very cold. Two days later and i still have dizzy spells and extreme fatigue.
40 2021-05-26 hot flush, night sweats Before the vaccine, I had complete normal monthly periods. 28 days clockwork. I have not had a perio... Read more
Before the vaccine, I had complete normal monthly periods. 28 days clockwork. I have not had a period since the vaccine. My FSH level have gone from normal, to 46.2mIU/ml. My prolactin is also elevated to 46.670 ng/ml CRP is elevated as well. I have hot flashes and night sweats and racing heartbeats. My doctor is going to re-run labs but has also ordered an MRI pituitary study
40 2021-05-26 numbness, facial paralysis Left side face numb, droopy; Huge cluster of cold sores left side face. Mouth and eye; Lips cherry r... Read more
Left side face numb, droopy; Huge cluster of cold sores left side face. Mouth and eye; Lips cherry red; Huge cluster of cold sores left side face. Mouth and eye; Left side face numb, droopy; Loss appetite; Kidney pain; mild body aches; tired and not wanting to do anything; simply not feeling well,; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old female non-pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at age of 40 years old as single dose for covid-19 immunization. Medical history included Asthma, allergies, Herpes Virus and Penicillin allergies. Concomitant medications included montelukast sodium (SINGULAIR); fluticasone propionate, salmeterol (WIXELA INHUB); salbutamol sulfate (PROVENTIL HFA); cetirizine hydrochloride (ZYRTEC ALLERGY); budesonide (RHINOCORT ALLERGY). No other vaccines received within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Covid tested not done post vaccination. The patient previously took Amoxicillin and experienced allergies, first dose of bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) (Lot number: EW0185) on 08May2021 10:13 AM at Right arm as single dose for covid-19 immunization. Adverse events occurred after 1st dose from 09May2021 07:00 AM included mild body aches, no arm pain, tired and not wanting to do anything after few days, simply not feeling well, loss appetite and kidney pain. Acyclovir was received as treatment and not recovered. After 2nd dose, lips were cherry red next day. By end of day, huge cluster of cold sores left side face, mouth and eye. Left side face was numb, droopy. The patient still had no will do anything but didn't feel sick. Loss appetite and kidney pain progressed from time 1st dose to 2nd. The outcome of the events was unknown. Information on lot number/batch number was requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event so facial droopy, huge cluster of cold sores left side face, mouth and eye cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : 2021530924 same patient/reporter/drug, different AE/dose
40 2021-05-26 migraine Worse migraine, palpitations, dizziness
40 2021-05-26 numbness and pain in extremities, tingling Starting on the 1st day of the 2nd dose vaccine-elevated heart rate, chills, fever, body aches, nau... Read more
Starting on the 1st day of the 2nd dose vaccine-elevated heart rate, chills, fever, body aches, nausea, neuropathy (hands, feet, arm and lower legs feels like pins and needles) and loss of appetite. Participant took Tylenol and Zofran. Fever and body aches resolved after 48 hours. Tachycardia and chest pains continued for up to 6 weeks. Participant had a follow-up already scheduled on 1/25/2021. Cardiologist doubled the dose of propranolol. As of now, cardiovascular symptoms and neuropathy are not resolved. MRI and stress test have been ordered .
40 2021-05-26 seizure After receiving vaccination, patient was reported to have fainted, with a potential seizure, and fal... Read more
After receiving vaccination, patient was reported to have fainted, with a potential seizure, and fallen over resulting in injury to head and laceration to forehead. Pharmacist was notified in which patient was immediately placed in laying position with elevation to her head and support to neck. Patient reported nausea, confusion, attempted to vomit without success. Patient was able to report name when prompted. 911 was called, fire service and ambulatory service arrived for further assessment. Patient was deemed safe without necessity of going to emergency room.
40 2021-05-27 discomfort, tingling, slurring Right side of body tingling and heaviness; Right side of body tingling and heaviness; slurred speech... Read more
Right side of body tingling and heaviness; Right side of body tingling and heaviness; slurred speech; difficulty walking; difficulty concentrating; urinary incontinence; This is a spontaneous report from a contactable other health professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided), via intramuscular, in right arm, on 05Feb2021 10:30 (at the age of 40-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included known allergies, and hypertension. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication was reported as "no". Patient did not receive other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and expiration date not provided), via intramuscular, in right arm, on 15Jan2021 14:00 (at the age of 40-year-old), at single dose, for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Feb2021, the patient experienced right side of body tingling and heaviness, slurred speech, difficulty walking, difficulty concentrating, urinary incontinence. Patient was hospitalized for 2 days. Events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures after the vaccination, which included COVID-19 test (Nasal Swab) was negative on 12May2021. No treatment received for events. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the events of right side of body tingling and heaviness, slurred speech, difficulty walking, difficulty concentrating, urinary incontinence cannot be excluded completely. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
40 2021-05-27 migraine, feeling hot Heart pounding and fluttering; Migraine headache; neck pain; dizziness; head and neck hot to the tou... Read more
Heart pounding and fluttering; Migraine headache; neck pain; dizziness; head and neck hot to the touch (no fever); eye pain; exhaustion; vertigo; mild nausea; Left temple throbbing and pulsating/headache; Heart pounding; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:30 (Batch/Lot Number: ER8736), age at vaccination of 40-years-old, as single dose, for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced migraine headache everyday, neck pain, dizziness, head and neck hot to the touch (no fever), eye pain, exhaustion, some vertigo and mild nausea, left temple throbbing and pulsating, heart pounding an fluttering occasionally, all on 30Apr2021 at 1730. No treatments were give for the events. Facility where the most recent COVID-19 vaccine was administered: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 10May2021. The patient had not recovered from the events. Information on the lot/batch number has been requested.
40 2021-05-27 pain in extremity I had the typical sore arm after the short for approximately 72 hours. The worst of it, the first 2... Read more
I had the typical sore arm after the short for approximately 72 hours. The worst of it, the first 24. I did get some intense diarrhea as well for a few days but as I'm near my period, I haven't any idea if it's due to that. On the 27th of May in the evening, I noticed my lymph nodes visibly swollen out of nowhere by my clavicle and they were incredibly painful to palpate. Upon going to the ER they noted that my lymph nodes in my throat were also swollen but not painful. This being a new thing to me, I called the nurse line who advised me to go to the ER. The ER said I didn't have cancer (not helpful) and would not talk about any side effects. I got a Covid test (negative). They sent me home and told me if I have issues breathing or anything, to return. 5/28 I started developing some nausea, congestion, headache, and fatigue, and I have lacked appetite all day. Around 6 pm I developed, so far, one hive on my abdomen.
40 2021-05-28 inability to speak, tremor, seizure, muscle spasms Onset of severe nausea followed by difficulty breathing, uncontrollable incessant dry heaving and co... Read more
Onset of severe nausea followed by difficulty breathing, uncontrollable incessant dry heaving and coughing, spasms, full body shaking, full body tremors, inability to speak, seizure like reaction, dizziness, tingling in tongue,
40 2021-05-28 depressed level of consciousness Symptoms: Nausea, dizziness, decrease in level of consciousness Treatment: epinephrine 0.3 mg IM, ca... Read more
Symptoms: Nausea, dizziness, decrease in level of consciousness Treatment: epinephrine 0.3 mg IM, called paramedics who arrived and continued care
40 2021-05-28 hot flush Metallic taste in mouth; Chills/hot spells; nausea; vomiting; body aches; hip and back pain; sharp p... Read more
Metallic taste in mouth; Chills/hot spells; nausea; vomiting; body aches; hip and back pain; sharp pain in left upper chest; Chills/hot spells; This is a spontaneous report received from a non-contactable Other-HCP. A 40-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN9581 and Expiration date not reported) via an unspecified route of administration, in Arm right, on 13Feb2021 at 02:30 PM (at the age of 40 years) as 2nd dose, single for COVID-19 immunisation. The patient medical history included Known allergies was reported as pseudoephedrine, Cephalexin, eggs, melon and concomitant medications included Multivitamin, St Johns Wort (medications in two weeks). Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246 and Expiration date not reported) via an unspecified route of administration, in Right arm, on 23Jan2021 at 02:30 PM as 1st dose, single for covid-19 immunisation. The patient didn't receive any other vaccine in four weeks. There was no covid prior vaccination. The patient was covid tested post vaccination. On 13Feb2021, at 02:45 PM, the patient had experienced Metallic taste in mouth and feeling hot initially, Chills/hot spells, nausea, vomiting, body aches, hip and back pain, sharp pain in left upper chest. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which includes Rapid Antigen Nasal Swab test post vaccination on 15Feb2021 with the result of negative, on 17Feb2021 with the result of negative, on 19Feb2021 with the result of negative, on 22Feb2021 with the result of negative, PCR Nasal Swab test on 24Feb2021 with the result of pending. There was no treatment received for AE. Outcome of the events was reported as Recovered with lasting effects. No follow up attempts are possible. No further information is expected.
40 2021-05-31 flushing April 15- second Covid shot April 22 - first big vertigo spell. Deafness then ringing in right ear A... Read more
April 15- second Covid shot April 22 - first big vertigo spell. Deafness then ringing in right ear April 23 - mild ringing in both ears and thumping, pressure in head May 4th - very noticeable ticking in right ear May 9th - felt sick, off, hard to take a deep breath, pounding head, fullness in ears, ringing, emotional May 11th - ENT visit. Ears clear, hearing fine May 18th - May 23- off and on headaches, difficulty breathing May 24th - Headache that didn?t go away with medicine. Fullness in ear. Nausea May 25th - Sleepless night, stiff neck, very full head. Medicine providing no relief(Excedrin, Sudafed, Flexeril) can feel fast heartbeat, ringing, and pulsation in ears, stiff jaw May 26-28 - light head congestion May 29- headache returns May 30- head congested even after Sudafed. Ears feel ?wet? hard to take a deep breath, lots of yawning. Flushed face and blotchiness on neck. May 31 - Difficulty breathing, ringing in both ears
40 2021-05-31 migraine, pain in extremity I sat down after vaccination and I felt sore right away up arm and up shoulder, went home, as drivin... Read more
I sat down after vaccination and I felt sore right away up arm and up shoulder, went home, as driving, migraine began, vomiting, couldn't smell. Had to go to Dr and get shot for headache and nausea, vomited for 2 days, loss of appetite, bad body aches. After that I was able to eat and drink bland and it subsided.
40 2021-05-31 tenderness I developed severely blotchy skin on my inner right thigh on Friday evening (5/28/21). It would not... Read more
I developed severely blotchy skin on my inner right thigh on Friday evening (5/28/21). It would not clear up and was subcutaneous (not chafing). It was a little sore to the touch in places. I did a Google search and was alarmed when one of the first things to pop up was possible clotting. I had also been experiencing strange heart fluttering/palpitations and my chest felt tight, like I couldn't take a deep breath comfortably. My husband brought home some chewable low dose aspirin. I took approx. 600mg (per directions - it said take 4-8 tablets every 4 hours). I took 8 tablets. Within 15 minutes the blotchiness started to fade in my leg, and within on hour it was 90% better. It was 100% better by the next morning. I have since been taking one low dose aspirin per day as a precaution. Heart palpitations also stopped with the aspirin. I emailed my doctor at the time of the event but have not heard back, as it was a holiday weekend. I chose not to go to the ER since the symptoms subsided, but I still worry and plan to see my doctor about this event. The heart palpitations were NOT a tachycardia event. I am all too familiar, and this was entirely different with chest tightness also noted.
40 2021-06-01 feeling hot Patient's whole body got warm right after the second dose as she was getting home. Caregiver gave he... Read more
Patient's whole body got warm right after the second dose as she was getting home. Caregiver gave her tylenol day flu as preventative care and continued with Tylenol extra strength for the next day twice.
40 2021-06-01 migraine, numbness I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had... Read more
I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had what looked like blinds (white/black) lines in my vision, then half moon shape in my vision in my right eye for days. Dizziness (I felt like I was on a boat dock), confusion, tiredness and pain the back of the eye for two weeks, numbness of the eyes. I went to the Opthalmologist who stated that I was having an ocular migraine. My Neurologist also said I was having an Ocular Migraine, but I?m stuck in the Postdrome Stage. Gave me Topiramate daily and told me stay away from screens and reading (that means no working and no TV). With the meds, I?m 70% back to my old self, I can drive again, run errands, do yard work, but I can?t work. We increased the dose, still can?t use screens and side effects pushed us to find another drug. Started new drug Amitriptyline on May 30, and symptoms are not disappearing. I have had symptoms (mostly eye numbness, vision issues, dizziness) continuously all day, everyday for 3 39 days and counting
40 2021-06-01 seizure like phenomena, inability to speak On 5/31/21, patient's husband described that the patient fainted and experienced seizure-like activ... Read more
On 5/31/21, patient's husband described that the patient fainted and experienced seizure-like activity. She reported nausea and dizziness before and after the episode. It took approximately 2 minutes for her to regain consciousness and she didn't have any recollection of what had happened. On 6/1/21, patient's daughter contacted nurse triage after she experienced forgetfulness and word-finding trouble, performed a FAST exam, and patient was admitted. Work-up pending.
40 2021-06-02 pain in extremity After receiving the first vaccine 3 week prior to this one (3/29/21) I had a vasovagal response a fe... Read more
After receiving the first vaccine 3 week prior to this one (3/29/21) I had a vasovagal response a few minutes after. After the second dose on 4/19/21, I did not have this same immediate response. The following day I had expected symptoms of headache, fatigue, soreness in arm. On the next day 4/21/21 i woke up feeling extremely fatigued, and felt heart palpitations. I also started to get a sharp pain in my chest near my heart area. I saw my cardiologist a few days later and wore a heart monitor for a week. They observed I was having premature atrial contractions. I was told the frequency was not an emergency issue. (But I should note I never had these before). Coupled with the pain in my chest I was worried about myocarditis. All symptoms began to decrease on may 14 and by may 17 were completely gone. My echocardiogram wasn?t until may 26 2021, over a week after my symptoms stopped, and was normal.
40 2021-06-02 seizure Had a Seizure 2 wks after vaccine. No family or previous history of seizures. Had to be taken to em... Read more
Had a Seizure 2 wks after vaccine. No family or previous history of seizures. Had to be taken to emergency room by ambulance.
40 2021-06-03 feeling hot, flushing Slightly lightheaded; Slight ringing in my ears; Resting heart rate began to increase; Facial/neck f... Read more
Slightly lightheaded; Slight ringing in my ears; Resting heart rate began to increase; Facial/neck flushing; Became hot; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200), via an unspecified route of administration on the left arm on 17Mar2021 at 14:15 (at the age of 40-year-old) for COVID-19 immunisation. Concomitant medications (within 2 weeks of vaccination) included vitamin E, hydrolyzed collagen, vitamin C, biotin. She has no known allergies to any medications, food, or other products. She did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, she had not tested positive for COVID-19. On 17Mar2021 (within 2-3 minutes after the vaccination), she became slightly lightheaded with a slight ringing in her ears; Her resting heart rate began to increase from 70 beats per minute up to 131 beats per minute with facial/neck flushing and she also became hot. The symptoms resolved within the next 2-3 minutes. It was also confirmed that she was 5 hours out from receiving the vaccine without further issue. No therapeutic measures were taken to treat these events. The clinical outcome for the events became hot, facial/neck flushing, resting heart rate began to increase, slightly lightheaded, slight ringing in her ears was recovered on the same day (17Mar2021). No follow-up attempts are needed. No further information is expected.
40 2021-06-03 numbness, speech disorder doesn't have much of appetite; 148/70 on the blood pressure; allergic response; tongue was a little ... Read more
doesn't have much of appetite; 148/70 on the blood pressure; allergic response; tongue was a little numb; hard to swallow; Throat was closing up; mouth feeling numb; couldn't really speak; Coughing; super shaky; feet was also feeling numb; face looked swollen; Chest tightness; chest pain; abnormal EKG; Her throat was a little sore; tired; This is a spontaneous report received from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left Arm on 17May2021 12:30 (Batch/Lot Number: EW0167) as single dose (at the age of 40-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number EW0158) on 15Apr2021 at 12: 50PM (at the age of 40-year-old) in the left arm for covid-19 immunisation and on 15Apr2021 her arm was numb on the side where she received the injection for more than 24 hours, it went numb pretty quickly after the first dose - then it was numb for about 24 hours. It went away completely in two days, but the patient was unsure if that is an adverse reaction. The patient experienced tongue was a little numb on 17May2021 with outcome of recovering , hard to swallow on 17May2021 with outcome of recovering , mouth feeling numb on 17May2021 with outcome of recovering , throat was closing up on 17May2021 with outcome of recovering , couldn't really speak on 17May2021 with outcome of recovering, coughing on 17May2021 with outcome of recovering, super shaky on 17May2021 with outcome of recovering, feet was also feeling numb on 17May2021 with outcome of recovering, face looked swollen on 17May2021 with outcome of recovering, chest tightness on 17May2021 with outcome of unknown, chest pain on 17May2021 with outcome of unknown, abnormal EKG on 17May2021 with outcome of unknown, her throat was a little sore on 17May2021 with outcome of unknown, tired on 17May2021 with outcome of unknown, doesn't have much of appetite on 20May2021 with outcome of unknown. Details as described as follows: Reports she went to sit in the waiting area, after 5 minutes she noticed her tongue was a little numb. She took her card out of her purse, and noticed it was a little hard to swallow, this was within about 8 to 10 minutes. She sat for another 5 minutes and then decided to ask about her tongue feeling numb and was taken to the nurses station. She told them about her tongue, and as she was talking her mouth was feeling more numb and it was getting harder to swallow. As the nurse was talking to her it was like she couldn't really speak. The nurse said this is way past Benadryl and called to another nurse for an Epipen. Caller states she started to cough as her throat felt like it was closing up. They jabbed her with the Epipen within 15 minutes of receiving the vaccine. She got some relief for a couple of minutes and then her body went back into the allergic response. They put her on the oxygen finger machine and then her throat started to close again. They gave another Epipen and then the ambulance arrived. She is unsure how long after she got the second Epipen that the ambulance arrived but it was no more than 5 minutes. They told her they had to call 911 right after giving the first Epipen. When the ambulance team came, she felt like she had novocaine in her mouth, her mouth was super numb and she was super shaky. They said the shaking was normal from an Epipen. Adds her feet were also feeling numb. She didn't know before that the shaking was from the Epipen. She was able to walk to the ambulance and her husband came and the med team was asking him if her face looked swollen and he said her face looked swollen. States her mouth felt like it was moving funny and she was exaggerating her speech trying to make her mouth move right. Adds she was still unaware that this could be an allergic reaction and was just trying to remain calm. At the site, she noticed her vitals on the machine and she saw 148/70 on the blood pressure. Adds it was about the same in the ambulance, it was 148/64. She was not able to collect any information about the Epipen other than they were yellow with a blue cap and they held it in her leg for three seconds. No lot or expiration date known for the Epipens. In the ambulance she was treated with Intravenous (IV) steroids and dose of Benadryl 50mg. As she was being transported to the hospital, she started to have chest pain. They did an EKG in the ambulance with no remarkable findings. Adds she has a follow up with her Primary Care Provider (PCP) today. When she arrived at the Emergency Room (ER) they monitored her for a couple of hours. She had another EKG at the ER and was told that it was normal so they released her. She has no product information for the steroids or the Benadryl that she received. No lot or expiration date known. When she got home everything was calming down. Her throat was a little sore and she was tired. The next morning her chest was still tight. She called the doctor who told her to just relax and come back to the ER if she has palpitations or difficulty breathing. Mentions she got the results of the EKG in ER now, and it said it was abnormal as compared to a previous EKG she had, and something about the T axis. Adds now she doesn't have much of appetite and her tongue still feels a little off. Caller interrupts the call to say her doctor just called and she needs to go. Unable to complete the report at this time. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.
40 2021-06-03 numbness arm was numb; This is a spontaneous report received from a contactable consumer (patient). A 40-year... Read more
arm was numb; This is a spontaneous report received from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left Arm on 15Apr2021 at 12: 50 PM (Lot Number: EW0158) as single dose (at the age of 40-year-old) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reported her arm was numb on the side where she received the injection on 15Apr2021. It went numb pretty quickly after the first dose - then it was numb for about 24 hours. It went away completely in two days. The outcome of the event was recovered on 17Apr2021. No follow-up attempts are needed. No further information is expected.
40 2021-06-03 numbness and pain in extremities, weakness, tingling Neuropathy initially in right arm, then subsided after two days. Neuropathy/tingling of fingers and ... Read more
Neuropathy initially in right arm, then subsided after two days. Neuropathy/tingling of fingers and toes returned with increasing sensation on May 21, 2021. On friday May 28, 2021 lips are now tingling and more feeling of full body tingling and weakness followed by close to fainting spells. Sunday night worst headache of life, followed by chills, almost fainted, went to ER and all tests normal. Neuropathy has not left. Sent home with no answers. Wednesday June 2, 2021 tingling of hands, feet and lips more extreme followed by moments of shortness of breath and fainting. Went back to ER all vitals normal. Two days later I have missed two days of work because my body is so weak and the nreopathy remains. Please help. I cannot continue to live with these symptoms. I had zero health issues leading up to this and all of the dr's are stumped.
40 2021-06-03 tingling, numbness Within minutes of shot, felt left cheek numbness and left eyelid felt off but resolved within the ho... Read more
Within minutes of shot, felt left cheek numbness and left eyelid felt off but resolved within the hour. For past week or so (vaccine 5/18, today 6/4) have felt random pins and needle stabs on my hands and feet. Past couple nights felt uncomfortable sensation bilateral lower legs that kept from being able to sleep, so walked around some before went away and could rest. This morning (6/4) woke and had right corner mouth spasms off and on for approximately 2 hours. (Unlikely due to low potassium as ate potato and banana night before).
40 2021-06-04 breast pain, pain in extremity pain in my right boob; maybe it is swollen; aching in my upper right arm; burning pain in my joints ... Read more
pain in my right boob; maybe it is swollen; aching in my upper right arm; burning pain in my joints of the vaccinated arm; extreme tiredness; all joints in my arm began to sting; extremely nauseous; sweaty; light-headed/mild dizzy spells; unable to think clearly; sudden down in blood sugar; foggy-headed; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 13:30 as 1st dose, single dose for COVID-19 immunization. Patient did not receive any vaccine in four weeks and not had COVID prior vaccination. Medical history included high blood sugar, asthma, scarlet fever survivor and patient had known allergy to latex. Concomitant medications included cinnamomum verum (CINNAMON TABLETS), quercetin, rhodiola rosea (RHODIOLA), and st johns (as reported). On 02Mar202 01:30, within 1 minute after vaccination, patient experienced all joints in arm began to sting. and was extremely nauseous, sweaty, light-headed, and unable to think clearly- very much like experiencing a sudden down in blood sugar. The doctor had patient to drink water and eat fruit. Patient reported it took about 15 minutes to be able to think clearly and was foggy headed for at least 24 hours. On 03Mar2021, (the after) patient experienced burning pain in joints of the vaccinated arm, extreme tiredness, and mild dizzy spells. On 05Mar2021, 3 days (yesterday) after vaccination, had pain in right boob and patient think maybe it was swollen as well as aching in upper right arm. Patient reported it still hurts today. Patient not tested COVID post vaccination. The patient underwent lab tests and procedures which included blood glucose: high. Therapeutic measures were taken as a result of extremely nauseous, sweaty, light-headed, and unable to think clearly- very much like experiencing a sudden down in blood sugar with water and fruit. The outcome of the events reported as recovered with sequelae (Recovered with lasting effects). No follow-up attempts are possible. No further information is expected.
40 2021-06-04 migraine Mild metal taste in mouth approx. 1 minute after shot was administered; Soreness in left arm, around... Read more
Mild metal taste in mouth approx. 1 minute after shot was administered; Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye; Fatigue; ended up sleeping nearly 12 hours; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 40-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0186), via an unspecified route of administration in Arm Left on 28May2021 15:00 (age at vaccination 40years old, No pregnancy at time of Vaccination) as single dose for covid-19 immunization. Medical history included lactose intolerance from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with covid-19. Concomitant medication(s) included Vitamin C, Vitamin D, Calcium Citrate, Iron taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination the patient was not diagnosed with covid-19. The patient received other medications in two weeks. On 28May2021 21:00 the patient experienced mild metal taste in mouth approx. 1 minute after shot was administered; dissipated a few minutes afterward. Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; no swelling. Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye. Fatigue; ended up sleeping nearly 12 hours. After 42 hours, migraine has gone away; remaining symptom is soreness - now reduced to half the area and still concentrated around site injection area. Patient was not received treatment for the events. Since the vaccination, the patient has not been tested for covid-19. The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
40 2021-06-06 weakness Pt reported difficulty breathing, swelling of face and throat, dizziness and weakness, pain, swellin... Read more
Pt reported difficulty breathing, swelling of face and throat, dizziness and weakness, pain, swelling and redness at injection site, sore throat, swollen lymph nodes, pain/tightness in chest, shortness of breath, headache, body aches, muscle aches, upset stomach, nausea, brain fog, fatigue, dizziness, and vertigo for six days after vaccination.
40 2021-06-06 burning sensation anaphylactic shock (fully body hives/extreme swelling of faces, neck, and limbs/ full body rash/pain... Read more
anaphylactic shock (fully body hives/extreme swelling of faces, neck, and limbs/ full body rash/painful itching/ feeling like a very intense burn) has lasted for 5 days causing hospitalization (has not gone away yet)
40 2021-06-06 pain in extremity, migraine After receiving the vaccine, I had a sore arm. The next day I felt extremely drowsy. I would sleep f... Read more
After receiving the vaccine, I had a sore arm. The next day I felt extremely drowsy. I would sleep for 4hrs wake for 2hrs and then need a nap again. This became a cycle. This was unusual because after the first vaccine, I only experienced common and minor side effect like aches and mild fever etc. The week after the vaccine, I began to have migraines with extreme pain, nausea and dizziness. These symptoms all became increasingly worse. I hadn't had a seizure since 2005, and in January, following the vaccine, I had one. My neurologist cannot determine the cause of this nor the migraines. My usual medication for my migraines do not work anymore. I have had to quit my job because I am a fall risk. I also must use a can to move around now to maintain my center of gravity.
40 2021-06-06 pain in extremity PAIN INTHE LEFT ARMS ,TICKLES AND I HAVE 2 DODULES ONE 5 MM AND ANOTHER 6 MM VERY SWALOW AND THE ARM... Read more
PAIN INTHE LEFT ARMS ,TICKLES AND I HAVE 2 DODULES ONE 5 MM AND ANOTHER 6 MM VERY SWALOW AND THE ARMA AND LEFT HAND IS VERY WEAK
40 2021-06-07 cold sweat, speech disorder speech difficulties (couldn't think of words, slurred words); Blurry eyesight; fever; clammy skin; h... Read more
speech difficulties (couldn't think of words, slurred words); Blurry eyesight; fever; clammy skin; headache; fatigue; itching skin; loss the ability to focus eyesight on phone, computer screen or books.; This is a spontaneous report from a Non-Contactable consumer (patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3302), via unspecified route of administration in the Left arm, on 25May2021 at 10:30 AM, as a single for COVID-19 immunisation. Medical history included Hypothyroid. Concomitant medications included armour, liothyronine and spironolactone. The patient had no known allergies. On 25May2021 at 02:30 AM, the patient experienced Blurry eyesight, fever, clammy skin, headache, fatigue, itching skin, speech difficulties (could not think of words, slurred words), loss the ability to focus eyesight on phone, computer screen or books. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did not received treatment for the events. The outcome of the events was recovered with lasting effects. No follow-up attempts are possible. No further information is expected.
40 2021-06-07 feeling hot, weakness My first dose on may 18th 2021. Side effects hit me 45 minutes later. Head ache, chills like flu, m... Read more
My first dose on may 18th 2021. Side effects hit me 45 minutes later. Head ache, chills like flu, my felt hot like I was on steroids. No fever. pain in arm where I recieved the shot, loss of appetite, weakness in my body. Body ached to the point I cried. It lasted for 5 days.
40 2021-06-07 pain in extremity Sore arm; This is a spontaneous report received from a non-contactable consumer, the patient. A 40-y... Read more
Sore arm; This is a spontaneous report received from a non-contactable consumer, the patient. A 40-years-old age female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 16Mar2021 at 02:00 PM (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient had no symptoms associated with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had no allergies to food, medication or other products. On 16Mar2021 at 03:00 PM, the patient experienced swelling sore arm. Therapeutic measures were not taken as a result of event. The clinical outcome for the sore arm was recovering at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-06-07 pain in extremity Symptoms are ongoing 8+ weeks post vaccine. I have had two doctors visits and numerous blood tests. ... Read more
Symptoms are ongoing 8+ weeks post vaccine. I have had two doctors visits and numerous blood tests. All normal. I was perfectly healthy prior to this other than a vitamin D deficiency that is now within the normal range. No known prior COVID exposure/infection. Have been maintaining a small, strict family bubble since March 2020 - working from home, home schooling my son, no travel or even going into stores. I had the normal/expected next day reaction to the 2nd shot - extreme fatigue, body aches, headache. I rested for the full day on Saturday and felt better /normal by Sunday morning. However, by late Sunday afternoon, new symptoms came on. They started out on the left side of my body and then grew from there in the days that followed. First it was pain behind my left knee that radiated down to my ankle and later upward through my left thigh, hip, entire arm, and shoulder. From there, it progressed to all over pain in my joints on both side of my body and almost daily headaches - typically around the base of my skull. I am also experiencing prolonged periods (days and sometime weeks at a time) of constant muscle tension/soreness in both arms and legs and intermittent tightness in my chest. However, the pain has remained most intense/pronounced/persistent on my left side and a couple of different times in the last 8 weeks I've had bruising on my left foot and ankle. As a result of all of this, I am fatigued most days and it is all inhibiting my ability to function normally. I don't know whether it is related to the vaccine or not, but I know it isn't normal. My quality of life and ability to function as I typically have has decreased dramatically in the last 8 weeks and I am very worried and I don't know what to do. If someone can please contact me and advise whether they have received any similar reports and provided direction on some type of specialist or test that might be able to help, I would be forever grateful as I am scared and my primary care physician has basically just said I need to wait it out.
40 2021-06-07 tingling, pain in extremity 3 days after getting 1 dose of Pfizer vaccine I started I had pain in my left arm and was losing fee... Read more
3 days after getting 1 dose of Pfizer vaccine I started I had pain in my left arm and was losing feeling from the injection site into my fingers--tingly feeling. Joint pain in both hands--this subsided about 10 days afterwards. 13 days afterwards, my abdomen swelled--normal waist is 27--went up to 30/31 inches. 15 days afterwards (today) ankles swollen and tingly in both feet but the left worse than the right. Period is also 10 days late as of today--I was regular before the vaccine.
40 2021-06-07 tremor 3:30 am that night I got shaking fever/chills. I expected that but about 5 days after the shot the i... Read more
3:30 am that night I got shaking fever/chills. I expected that but about 5 days after the shot the inside of my mouth was in a lot of pain. A fever blister formed on my lower lip (left) and the inside of my mouth felt raw. It has been going on 2 days now- it?s hard to eat and hurts to talk. My gums are sore and I can feel raw spots on the roof of my mouth-like blisters.
40 2021-06-08 weakness I went to urgent care at 2:30 pm in the afternoon on 4/16 which was a Friday. I got my shot I was fi... Read more
I went to urgent care at 2:30 pm in the afternoon on 4/16 which was a Friday. I got my shot I was fine. Around 5pm - 6pm dinner time on Sat 4/17 I started to feel off. I was feeling weak and tired. I woke up on the morning of the 17th and I was horribly sick. I had a low grade fever a little over 100 to 101 degrees I had chills and shakes similar to flu symptoms. I had no appetite and did not want to drink anything. I slept the entire day I had a horrible headache I felt really crappy. I did vomit once but none after that. Monday morning the 19th I started to feel better I was still running a low fever in the 99-100 degree range. At that point I was able to get fluids in and eat and was able to keep everything down. I still had a headache and was feeling run down . Tuesday morning the 20th I was feeling much better I still had a headache but basically all other symptoms had subsided.
40 2021-06-08 numbness, pain in extremity left arm pain, axillary swelling for 4 weeks, difficulty lifting coffee cup initially, and heavier t... Read more
left arm pain, axillary swelling for 4 weeks, difficulty lifting coffee cup initially, and heavier things still a month later. Fingertips numb, different than prior carpal tunnel symptoms, which had resolved after surgery in 2013.
40 2021-06-08 pain in extremity The evening following the 2nd dose of covid 19 vaccine my arm was sore and I was tired. That night i... Read more
The evening following the 2nd dose of covid 19 vaccine my arm was sore and I was tired. That night it progressed into a fever of 104, severe body aches in almost all my joints, headaches, bradycardia and body chills. The fever was minimal reduced by switching Tylenol and Ibuprofen every few hours to about 102. Fever, chill and body aches started to subside in about 24 hours. Today I have sore throat, pressure/fluids in ears, slight chest pains and bradycardia, light headache and swollen lymph nodes in throat , inject site is still sore but most bothering is dizziness that is setting in.
40 2021-06-09 pain in extremity Received 2nd shot last week. 1st shot 3 weeks before. Baby stopped growing last week at 9 weeks. Al... Read more
Received 2nd shot last week. 1st shot 3 weeks before. Baby stopped growing last week at 9 weeks. Also after 2nd shot last week my left arm was so sore, I couldn?t lift it up. Lasted overnight and went away.
40 2021-06-09 tingling patient had tingling on face starting on 6/3/21, on 6/4/21 broke out in rash, on 6/5/21 rash broke o... Read more
patient had tingling on face starting on 6/3/21, on 6/4/21 broke out in rash, on 6/5/21 rash broke open to open sores\ 6/10/2021 diagnosed with shingles
40 2021-06-09 seizure Asthma; Oxygen was 89; Shortness of breath/breathing difficulties; Ribs hurt; Felt like she was comi... Read more
Asthma; Oxygen was 89; Shortness of breath/breathing difficulties; Ribs hurt; Felt like she was coming down with the flu; Head and sinus congestion; Head and sinus congestion; Throat was on fire, it hurt so bad; Throat was on fire, it hurt so bad; Seizure; Kind of achy/achy feeling; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in left arm on 22May2021 10:45 (at the age of 40 years old) as 1st dose, single for COVID-19 immunization, at a pharmacy. Medical history included epilepsy from an unknown date and unknown if ongoing (seizure free for two years; diagnosed in 2009 or 2010). Concomitant medications were not reported. On 23May2021, the patient was having breathing difficulties and had to go the emergency room (ER). The patient reported she went to the ER Monday, 24May2021 and was released 11 hours later. She also stated that on Sunday morning on 23May2021, she woke up at 0400 AM and her throat was on fire, it hurt so bad. This was Sunday at 0400, and her husband heard her, and they walked around the house, she had her hands over head, like when running and her ribs hurt. She raised her arms, and tried to take deep breaths, and it was working, to breathe, but it felt like she couldn't breathe, she couldn't catch her breath. She stated she went to work and in 1.5 hours came home, she called the pharmacy and said she can't breathe, then she was told this is not normal. She was told to go to the hospital, and she went and stated that her oxygen was 89 and then it shot up to 92 with standing and raising her arms up over her head, and they did 6 breathing treatments and 3 doses of steroids in her IV and oxygen and she went up to 98. She was sent home with a diagnosis of asthma with albuterol inhaler and nebulizer machine, treatments and said that she all of a sudden has asthma. She then added she had a seizure Sunday morning of 23May2021. She also felt like she was coming down with the flu. On 22May2021, Saturday night, she was kind of achy, then on Sunday, 23May2021, she felt like she was coming down with flu, she had head and sinus congestion, the achy feeling, all that was fine, it was the breathing that scares her. The patient was not hospitalized due to the events. The outcome of the event seizure was unknown and for other events was recovering.
40 2021-06-09 seizure Increased frequency of seizures
40 2021-06-09 tremor dizziness; fever; chills; nervousness; Headache; sleepiness/drowsiness; shaking; diarrhea; This is a... Read more
dizziness; fever; chills; nervousness; Headache; sleepiness/drowsiness; shaking; diarrhea; This is a spontaneous report from a contactable consumer (the patient). A 40-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 06Mar2021 16:00 (Batch/Lot Number: Pfizer EL9267) as single dose for covid-19 immunisation (Age at vaccination 40 years) . Medical history included penicillin hypersensitivity. Concomitant medications included ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. On 13Feb2021 the patient received the first dose of BNT162B2 vaccine (Lot #Pfizer EN5318). The patient experienced dizziness on 07Mar2021 09:00 with outcome of recovering , fever on 07Mar2021 09:00 with outcome of recovering , chills on 07Mar2021 09:00 with outcome of recovering , nervousness on 07Mar2021 09:00 with outcome of recovering , headache on 07Mar2021 09:00 with outcome of recovering , sleepiness/drowsiness on 07Mar2021 09:00 with outcome of recovering , shaking on 07Mar2021 09:00 with outcome of recovering , diarrhea on 07Mar2021 09:00 with outcome of recovering. The patient received paracetamol (TYLENOL), increased fluid intake and bed rest as treatment of the events. No follow-up attempts are possible. No further information is expected.
40 2021-06-10 migraine, pain in extremity mild migraine; sore arm; Caller stated she noticed that she is constipated; This is a spontaneous re... Read more
mild migraine; sore arm; Caller stated she noticed that she is constipated; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0191), via an unspecified route of administration, on Arm Left on 05Jun2021, as a 1st dose single for COVID-19 immunization. The patient medical history included ongoing irritable bowel syndrome (She does take a homeopathic pill, but she hasn't been taking it) and gallbladder removed. The patient's concomitant medications were reported as none. It was reported that, the patient got her first Pfizer COVID vaccine on 05Jun2021 (Saturday). On the same day (05Jun2021), when she got home, she had a mild migraine and sore arm. The same thing yesterday (06Jun2021) and today (07Jun2021). The migraine was only on the left side of her head, and it started 2 to 3 hours after the COVID vaccine. It went away 8-9 hours later. She took a small nap to help the migraine, and when she woke up, she felt the soreness. The sore arm started that night. She still has a little arm soreness. She got the shot in her left arm, and the soreness was in her left arm. Then, today she noticed that she has been constipated since the shot. She has IBS (irritable bowel syndrome), and normally when she has to go. She doesn't take medication for IBS because she doesn't have insurance. She does take a homeopathic pill, but she hasn't been taking it because she went on vacation. She noticed the constipation because after the vaccine she went and got her family breakfast. She always goes after eating. She ate three meals a day and still hasn't went. She has had her gallbladder removed, so she always goes. This was not like her, and she went fine on Friday. It was further stated that, she hasn't been taking the homeopathic pill for about a week and a half to two weeks now because she was on vacation. It was an IBS therapy pill (by Manufacturer TRP). The outcome of the event mild migraine was recovered on 05Jun2021, whereas not recovered from other events.
40 2021-06-10 pain in extremity, tingling, numbness Shortly after the shot (on the same day as the shot), I had some expected side effects, including ar... Read more
Shortly after the shot (on the same day as the shot), I had some expected side effects, including arm soreness, headache and fatigue. Toward the evening, I began experiencing aches throughout my body, pins and needles, and mild chest pain. The next day, my right lower leg and foot became numb (felt like it was "asleep"). The leg/foot numbness persisted (on and off) for over a week, and kept me awake at nights because it was so unusual and couldn't be shaken off. Over the next week, I also developed stiff joints on my hands, fingers and feet, as well as various pains in those areas. Exactly one week after the vaccine, my chest pain became much more severe and localized to my heart. It felt like my heart was being squeezed. I felt some shortness of breath as well, so I used a finger pulse oximeter to take my oxygen. My oxygen reading was normal, but my heart rate reading did not stabilize (it kept changing from 90's to 60's). My headache was also much more severe and I could not do much for the next two days except rest. After 3 days, the chest pain went away. However, I still have pins and needles and joint pain/stiffness that comes and goes. Summary: Arm soreness: Started on the day of the vaccine and lasted about 4 days, then came back briefly exactly one week later. Headaches: Started on the day of the vaccine and lasted for over a week. Fatigue: Started on the day of the vaccine and lasted for over a week. Body aches: Started the evening of the vaccine and lasted over a week Pins and needles: Started the evening of the vaccine and lasted over a week (still ongoing) Chest pain: Started the evening of the vaccine and became very severe (with irregular heart rate) one week after the vaccine Numbness: Started the day after the vaccine and lasted over a week (still ongoing) Stiff and painful joints: Started the day after the vaccine and lasted over a week (still ongoing)
40 2021-06-11 weakness Dizziness, blurriness, weakness to the point of blacking out and falling. I woke up in the bathtub w... Read more
Dizziness, blurriness, weakness to the point of blacking out and falling. I woke up in the bathtub with a huge lump on my head bleeding.
40 2021-06-12 numbness 06/02/2021- Immediately (under 5 minutes) - Mottled skin on both legs, upper and lower (last 45 minu... Read more
06/02/2021- Immediately (under 5 minutes) - Mottled skin on both legs, upper and lower (last 45 minutes), Extremely dizzy and lightheaded. Face went dumb 4 hours after vaccine, both legs turned bright pink like sunburn 10 hours after vaccine. 06/03/2021 - Broke out in hives on inside of arms. Lasted 3 days and no longer there 06/08/2021 - Metrorrhagia (my period was not due for 10 more days, I am always exactly regular for my whole life) 06/08/2021 - Hypoglycemia (Multiple episodes since vaccination, Bloodwork showed one episode of 56 mg/dL) No history of diabetes. Hypoglycemic episodes still happening as of 06/13/2021 when blood sugar was 72.
40 2021-06-12 pain in extremity Sharp pain in left leg toe for 30 minutes then a bumpy feeling. Next day morning showed up a bruise ... Read more
Sharp pain in left leg toe for 30 minutes then a bumpy feeling. Next day morning showed up a bruise kind of spot (blood clot). No numbness, itchiness or pain in that area.
40 2021-06-13 pain in extremity I had a sore arm. I had a really bad headache and a serve fever. I had to sleep it off for at least... Read more
I had a sore arm. I had a really bad headache and a serve fever. I had to sleep it off for at least 3-4 hrs. I am due January 16th.
40 2021-06-14 night sweats I have had an increase heart rate, chest pressure (especially when laying down), night sweats, and s... Read more
I have had an increase heart rate, chest pressure (especially when laying down), night sweats, and shortness of breath, swollen throat) since receiving that second vaccine. I have gone to urgent care and also a PCP, who have not diagnosed anything, yet. Everyone thinks it is my anxiety.
40 2021-06-14 tingling Left arm pain radiating to should and scapula. Unable to lift arm above head without having pain. Ti... Read more
Left arm pain radiating to should and scapula. Unable to lift arm above head without having pain. Tingling in finger tips that come and go. My body doesn't feel the same after my second dose of the vaccine.
40 2021-06-15 weakness Headache, weakness, dizzy, and fever continued for a 48 hour time span
40 2021-06-15 tingling Symptoms - Right eye swelling on June 10, rash on right side of face on June 11, swollen lymph nodes... Read more
Symptoms - Right eye swelling on June 10, rash on right side of face on June 11, swollen lymph nodes on June 12, face tingling on June 15. Initial Diagnosis - Stye on June 13 Later Diagnosis - Shingles on June 16 Initial Treatment - Prednisone and Clindamycin Later Treatment - Valacyclovir
40 2021-06-15 unresponsive to stimuli, flushing Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / ... Read more
Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: The Patient fainted after receiving the covid vaccine. EMS came and attended to the patient. She left the store with her husband.
40 2021-06-16 weakness I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experien... Read more
I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experiencing headache, chills, fever, body aches and weakness.; This is a spontaneous report received from a contactable consumer. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unknown route of administration on the left arm on 18Mar2021 08:15 (age at vaccination was 40-year-old) as single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via unknown route of administration on the left arm on 26Feb2021 as single dose for COVID-19 immunisation. Medical history of the patient included myasthenia gravies. Patient was allergic to hydromorphone and promethazine. Concomitant medications included prednisone (MANUFACTURER UNKNOWN), CELLCEPT, gamunex (MANUFACTURER UNKNOWN), MESTINON and SOLIRIS. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 18Mar2021 at 17:30 after receiving the second dose of vaccine in her left arm, the patient experienced headache, chills, fever, body aches and weakness. The patient did not receive any treatment for the events. The clinical outcome of events headache, chills, fever, body aches and weakness were not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
40 2021-06-16 pain in extremity, facial pain constant nausea; facial and sinus pain; facial and sinus pain; headache; Sore left arm; This is a sp... Read more
constant nausea; facial and sinus pain; facial and sinus pain; headache; Sore left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 20Feb2021 11:00 at the age of 40-years-old as unknown, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, on an unspecified date received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 21Feb2021 at 16:00, the patient experienced constant nausea for 3 days, facial and sinus pain, headache, and sore left arm and did not receive treatment for adverse events. The outcome of events was not recovered. No follow up attempts are needed. No further information is expected.
40 2021-06-16 tingling, throat numbness, numbness Rash on face and chest; periodic numbness and tingling in left side of face/cheek is ongoing still/N... Read more
Rash on face and chest; periodic numbness and tingling in left side of face/cheek is ongoing still/Numbness and pins and needles feeling in left side of face and cheek; Numbness in left side of face, tongue and throat; Numbness in left side of face, tongue and throat; Numbness in left side of face, tongue and throat; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A 40-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0172, Expiration date: unknown) via unspecified route of administration, administered in left arm on 05May2021 at 16:30 pm (age at vaccination was 40 years) as first dose, single dose for COVID-19 immunization. The patient did not have any medical history. The patient had known allergies to penicillin and carmel color, eggs, pistachios. Concomitant medications the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), ascorbic acid, beta vulgaris root, iron amino acid chelate, rosa canina fruit, rubus idaeus leaf (IRON SUPPLEMENT WITH VIT C & HERBS) and Multi Vitamin. The patient previously took amoxicillin, erythromycin, z-pac, codeine and experienced drug allergy. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 05May2021 at 16:45 pm, the patient experienced numbness in left side of face, tongue and throat, starting 15 minutes after the shot. Throat and tongue were back to normal after 24 hours. Numbness and pins and needles feeling in left side of face and cheek continually for 3 weeks, periodic numbness and tingling in left side of face/cheek was ongoing still. Rash on face and chest began 48 hours after shot and lasted 3 days. The device timestamp and device date was reported as 07Jun2021. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The events were reported as non-serious. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
40 2021-06-16 tingling I started to get a weird quick sensation that started in my chest and moved down my body(kind of lik... Read more
I started to get a weird quick sensation that started in my chest and moved down my body(kind of like when you go over a hill really fast but intensified)/felt like something inhabiting my body; really freaked me out; wasn't sure if I was going to pass out or not; my arm felt tingly, like when you hit your funny bone; This is a spontaneous report from a contactable consumer(patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration in the right arm on 14May2021 04:45 PM (at the age of 40-years-old) as first dose, single dose for COVID-19 immunization at a Pharmacy/ drug store. The patient's medical history was not reported. Concomitant medications included progesterone and estradiol; both taken for an unspecified indication, start and stop date were not reported. Patient was also reported to be on hormone replacement therapy. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 14May2021, right away after the shot, the patient experienced or felt tingly arm, like when you hit your funny bone (reported to have waited for 15 mins and felt fine) and on the way home about 25-30 mins after the shot, at 05:30PM, the patient experienced a weird quick sensation that started in her chest and moved down her body (reported as kind of like when you go over a hill really fast but intensified) and felt like something inhabiting her body (which was reported to have lasted probably less then a minute), that really freaked her out and wasn't sure if she was going to pass out or not. Luckily she was close to home. No treatment was given for the events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-06-17 numbness Numbness of my right hand, and blotchy vision -- white spots on vision
40 2021-06-17 pain in extremity Blisters; itching; pain on left hand; This is a spontaneous report from a contactable consumer (pati... Read more
Blisters; itching; pain on left hand; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Er8732; Expiration date was not reported), via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 40-years-old) as first dose, single dose for COVID-19 immunization. Medical history included arthritis, colon polyps, PTSD, ADHD, bulging disc and depression; all from unknown date and unknown if ongoing. Concomitant medications included hydrocodone and zolpidem tartrate (AMBIEN); both taken for an unspecified indication, start and stop dates were not reported. The patient previously took metoclopramide (REGLAN) and experienced drug allergy. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 08Apr2021, the patient experienced blisters, itching and pain on left hand. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Treatment with steroids pills, steroids shot and 4 creams were taken as a result of the events. The outcome of the events was not recovered. The patient was vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ew0161; Expiration date was not reported), via an unspecified route of administration on 27Apr2021 (at the age of 40-years-old) as second dose, single dose for COVID-19 immunization.
40 2021-06-18 migraine Tachycardia; Fever; Migraine; Fatigue; not feeling well; shortness of breath; This is a spontaneous ... Read more
Tachycardia; Fever; Migraine; Fatigue; not feeling well; shortness of breath; This is a spontaneous report from a contactable other health professional (patient). A 40-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (at the age of 40 years old, not pregnant at the time of vaccination) (Lot Number: EL3249) as single dose for covid-19 immunisation. Medical history included migraine, attention deficit hyperactivity disorder (ADHD), irritable bowel syndrome (IBS-C), Gluten intolerance, Gulten allergy. Concomitant medications received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ibuprofen; topiramate (TOPAMAX); linaclotide (LINZESS). The patient previously received the first dose of BNT162B2 (Pfizer, lot number: EJ686) in Left arm on 01Jan2021 (at the age of 40 years old) for Covid-19 immunization. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Jan2021, the patient experienced Fever, migraine, fatigue, not feeling well, shortness of breath, tachycardia. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Beta blocker, labs, holter monitor, ekg, echo, str. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Covid test Nasal Swab post vaccination with the result of Negative. The events were non-serious per the reporter. The outcome of the events was Recovered with lasting effects.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the events of Fever, migraine, fatigue, not feeling well, shortness of breath, tachycardia cannot be excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-06-18 muscle spasms Patient was approximated 10 weeks pregnant and received her second dose of the Pfizer vaccine on 6/... Read more
Patient was approximated 10 weeks pregnant and received her second dose of the Pfizer vaccine on 6/16. Four hours later, she began cramping and spotting. This worsened over 3 days. She began hemorrhaging hours prior to her ER visit . She was hypotensive and required an urgent suction curettage
40 2021-06-18 pain in extremity circular rash m/spot at the site; pain to the site; excruciating pain to the entire left arm and nec... Read more
circular rash m/spot at the site; pain to the site; excruciating pain to the entire left arm and neck; excruciating pain to the entire left arm and neck; This is a spontaneous report received from a contactable nurse. A 40-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no. EN6198) via an unspecified route of administration in the left arm on 06Mar2021 at 09 15, as a single dose for COVID-19 immunisation. Medical history included asthma and migraines. Concomitant medications included TYLENOL, SYMBICORT, albuterol (UNKNOWN MANUFACTURER UNKNOWN), ZYRTEC taken within 2 weeks of vaccination. The patient had allergies to aspirin and NSAIDS. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested positive for COVID- 19. On 17Mar2021, the patient experienced pain at site and excruciating pain in the entire left arm and neck, also noticed a circular rash m/spot at the site on 18Mar2021 which got larger on 19Mar2021. The clinical outcome of vaccination site pain, vaccination site rash, excruciating pain to the entire left arm and neck was not recovered. No follow-up attempts are needed. No further information is expected
40 2021-06-18 tingling reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 ... Read more
reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks; intense pain in reproductive organs; Bloating; now growths (possibly cervical polyps); dull achy sore pain where the shot was administered; tingliess in her fingers on that arm; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown, NDC 59267100002) via an unspecified route of administration at left arm on 13Apr2021 12:00 (40-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included depression and ADHD. Concomitant medications in two weeks included dextroamphetamine hydrochloride; alprazolam; sertraline hydrochloride (ZOLOFT); hydroxyzine hydrochloride (VISTARIL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 23Mar2021 11:00 (40-year-old at time of vaccination) for COVID-19 immunization. Patient did not receive any other vaccines within 4weeks prior to the COVID vaccine. Event start date was reported as 14Apr2021 15:00. Patient has had a dull achy sore pain where the shot was administered ever since she received the last shot. She also has tingliess in her fingers on that arm. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for these adverse events. The patient also reported intense pain in reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks. Bloating and now growths (possibly cervical polyps)- visting OBGYN for follow up. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The case was serious, medically significant. No therapeutic measures were taken as a result of the event "dull achy sore pain where the shot was administered" and "tingliess in her fingers on that arm". The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-06-19 breast pain, pain in extremity, night sweats Aside from 2nd dose giving 102 fever, diarrhea, vomiting etc. for 2.5 days post 2nd vaccine- and con... Read more
Aside from 2nd dose giving 102 fever, diarrhea, vomiting etc. for 2.5 days post 2nd vaccine- and continual diarrhea now a month later: My menstruation was 10 DAYS LATE after the second dose. Took a pregnancy test on day 7 of missed period and it was negative just to be clear . Period came and was heavier than normal along with more intense cramps. Now, more than a month later my second post vaccine period came 7 DAYS EARLY and for the days leading up to this early period I?ve had breast pain (which isn?t a normal PMS symptom for me) along with intense cramping and heavier blood flow.
40 2021-06-19 fibromyalgia, pain in extremity 5 days later developed rash and still lump at injection site. In day or 2 following injection, arm w... Read more
5 days later developed rash and still lump at injection site. In day or 2 following injection, arm was sore, some flare up in systemic fibromyalgia pain.
40 2021-06-20 muscle spasms I have been bleeding since the shot.
40 2021-06-22 breast pain, pain in extremity Severe left arm soreness that developed into lymphadenopathy-significantly swollen armpit and pain i... Read more
Severe left arm soreness that developed into lymphadenopathy-significantly swollen armpit and pain into the left breast. Followed by severe abdominal pain that worsened over 5 days with significant nausea.
40 2021-06-22 migraine Migraine , fatigue, loss of appetite
40 2021-06-24 breast pain Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast/Lymph n... Read more
Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast/Lymph nodes enlarged on right neck \extremely painful even without touching; Right leg: joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; Right leg: joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; Lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; difficult swallowing due to the pain; Right ear painful, feeling like too much pressure on it; Right ear painful, feeling like too much pressure on it; Right head painful, excruciating pain; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ew0185 and Expiry date: Unknown), via dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took penicillin [penicillin nos] for drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with covid 19 and has not been tested for COVID-19 Since the vaccination. On 21May2021, the patient experienced right leg: joint pain, shooting pain here and there along the leg, hip pain, leg muscle weakness; lymph nodes enlarged in left armpit, painful armpit, and the pain radiates to my left breast; lymph nodes enlarged on right neck (multiple places: under chin, above collar bone, beside right ear), extremely painful even without touching, difficult swallowing due to the pain; right ear painful, feeling like too much pressure on it and right head painful, excruciating pain. The patient was not received any treatment for the events. The outcome of events was not resolved.
40 2021-06-25 weakness On January 7th, I complained to a doctor about right arm elbow pain. She told me to keep an eye on ... Read more
On January 7th, I complained to a doctor about right arm elbow pain. She told me to keep an eye on it. I had a telehealth visit on January 13th d/t worsening pain, had a negative x-ray that day. The pain became much more severe and I was unable to do the following ADLs without significant pain: pick up my daughter (< 30 lbs), roll over in bed, turn on the shower, pick up a heavy pan, pick up my purse to put it on my right shoulder, boost patients at work, fully extend/flex my right arm. At PCP's recommendation, I started seeing a PT 3x/week on February 2nd. She found reduced ROM and strength in right arm, unable to fully flex/extend. Unfortunately, traditional PT increased my pain, spread to right shoulder and back, all related to elbow per PT. I tried CBD cream (at PCP's recommendation), OTC pain meds, daily PT exercises/stretching, pain meditations, acupuncture, and massage, none of which improved pain. I eventually needed a prescription for a muscle relaxer to be able to work, which was very distressing, as it required pausing attempts to conceive. I found a great deal of relief with a PT who did myofascial relief, but due to multiple scheduling issues I was unable to get on the caseload of a PT who specialized in this. I eventually abandoned PT, as it did not help (and made things worse), spent over $500 out of pocket on PT alone (not to mention all the other significant costs). I finally found some relief from seeing a chiropractor, was able to discontinue muscle relaxers. Right arm pain is still not fully resolved, 6 months later. I can do ADLs again, occasional pain, strength and ROM are still reduced.
40 2021-06-26 discomfort Approximately 3 days after the 2nd dose - Slight symptoms of hemorrhoids; however, this one was not ... Read more
Approximately 3 days after the 2nd dose - Slight symptoms of hemorrhoids; however, this one was not as severe as after the first dose. This only included slight discomfort/itching. I only had to use 1 or 2 treatments of Tucks before the symptoms disappeared (last about a day or two). No medical treatment was sought for either the first or second occasion. Ongoing - Starting perhaps a month after my 2nd dose, I've begun having mucus build up in my sinuses. In addition, I frequently experiencing a "tickle" in my throat that triggers coughing. The sinus build up happens throughout the day and is usually resolved by "snorting" and either spitting out (or swallowing) the mucus. I haven't kept track of the color, though. This is something very abnormal for me, as I've never had sinus build up (except for sometimes during allergies or colds). I have not had an allergy issue or cold leading up to or during these issues. Also, the "tickle" in my throat that triggers coughing, happens intermittent, maybe once or twice a day. It can trigger coughing fits of varying lengths. Both the sinus build up and throat tickle are ongoing. I have not yet sought medical treatment as they don't really impact my day to day; they are just things that I've noticed happening now (that did not occur prior to the vaccination). I'd like to mention that I did not experience any of the typical "flu-like" symptoms immediately after receiving either COVID vaccine dose. I was prepared for and expected to get sick. However, I had no typical flu-like adverse reaction at all within 48 hours of receiving either dose.
40 2021-06-26 pain in extremity, flushing, tingling 12 hrs post injection: facial flushing, prickly feeling all over body/skin, nausea, body aches, raci... Read more
12 hrs post injection: facial flushing, prickly feeling all over body/skin, nausea, body aches, racing pulse 24 hrs post injection: persistent facial flushing/rash, facial blotches & bumps, upper back and neck aches, head ache, fatigue, right thumb joint pain 48 hrs post injection: right thumb/pinky joints painful & stiff 3 days post injection: both thumbs and most fingers painful & stiff (consistent for 1 month, sporadic to present) 1 week post injection: Noticed occasional low-grade fevers (99-100 degrees), continues to present 3 week post injection: Developed head pain in/around temples, sides of forehead, and scalp. These are sudden bursts of pain/ache and occasionally persistent throbbing. Veins on side of forehead are swollen and bulging. Stiff and painful neck and SI/lower back that would cause me to wake during sleep. Nausea, fatigue, and head pains continued. Occasional sore throat. Temples and scalp tender to touch and hurt when chewing or talking. Other veins throughout body appear more visible. 8 weeks post injection (present): Symptoms continue to include Rosacea flare up and everything listed at 3 weeks post injection to include sporadic pain in thumb and finger joints.
40 2021-06-27 pain in extremity The day following the shot I had a very sore arm (which was to be expected) this went away in a day ... Read more
The day following the shot I had a very sore arm (which was to be expected) this went away in a day or two and felt completely fine after. On day 9/10 following the vaccine, I woke up with severe pain in the same arm at the injection point and pain with mobility of the same shoulder. Later the same day I unexpectedly began my menstrual cycle. It was 7 days early. It's never early, ever. My cycle is down to the day and regular, always. No usual menstrual cycle indicators/symptoms prior to it beginning either. The day after my cycle started, I noticed my heartbeat was pounding very loudly at night in bed, this lasted for 3 days with moments of minor chest tightness in the center of the chest, which was concerning, I almost opted to go to ER. this sensation subsided on the 4th day and has not returned.
40 2021-06-28 tingling, numbness Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (s... Read more
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Chills-Mild, Systemic: runny nose and eyes-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: onset of adverse effects started about 30 minutes after vaccination
40 2021-06-29 feeling hot Chills/full body aches/ heavy head/sensitivity to light/Fever 101.7/Feeling hot.
40 2021-06-29 numbness This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old female... Read more
This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route administration in the right arm on 12Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient previously received levoquin Zithromax (Z-PAK) and echinacea (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested positive for COVID-19. The patient underwent lab test and procedures, which included COVID-19 virus test on 22Mar2021 and tested negative. On16Mar2021, the patient experienced facial numbness on the outside of face and lasted 2-3 days, about a week after, the patient experienced numbness inside mouth and 9 days (20Mar2021) after the vaccine loss of taste, it was still present at the time of report. Therapeutic measures were not taken for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events facial numbness on the outside of face was resolved on an unknown date in Mar2021, while the clinical outcome of numbness inside mouth was unknown and loss of taste was not recovered at the time of report. Information about lot number cannot be obtained. No further information is expected.
40 2021-06-29 tingling my right foot started to feel weird- felt wet or tingly sometimes; my first menstruation after vacci... Read more
my right foot started to feel weird- felt wet or tingly sometimes; my first menstruation after vaccinehad many small blood clots, which isnot normal for me; This is a spontaneous report from a contactable consumer, the patient. A 40 -year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6206) via an unspecified route of administration in the right arm on 04Mar2021 at 18:30 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included patient was allergic to shellfish. No concomitant therapies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The. Three days after the vaccine, on 07Mar2021 at 11:00 the patient experienced right foot started to feel weird and felt wet or tingly sometimes however the foot was not swollen. The patient still had those sensations 18 days after vaccine. Also, the patient first menstruation after the vaccine had many small blood clots, which was not normal for her. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of tingling foot and small blood clots in menstruation was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-06-30 weakness Swelling , sick and in bed, then found a large rash on left breast, small boil , covid arm, chills l... Read more
Swelling , sick and in bed, then found a large rash on left breast, small boil , covid arm, chills low energy for 4 days
40 2021-06-30 pain in extremity Left arm (where shot was given) continues to ache and be somewhat weak through left hand more than a... Read more
Left arm (where shot was given) continues to ache and be somewhat weak through left hand more than a week after the vaccine. Feel a lump and tenderness in left underarm. Tenderness has spread to chest near collar bone.
40 2021-06-30 tremor Felt faint and body shaking immediately, after that sat during 15 min observation period. Had some... Read more
Felt faint and body shaking immediately, after that sat during 15 min observation period. Had some more body shaking and feeling faint. Thought it was a normal vaccine reaction. Went to the car w/daughter after observation period. As she was leaving the parking garage she started having palpitations, was holding her chest, starting "doing breathing techniques." Throat then "dried out," drank water, then after a while it was hard to drink the water. Daughter told her that her face was swollen. Pulled the car over, had daughter call family to come and help, daughter drove her to a pharmacy where they purchased Benadryl. Patient took the Benadryl. Family arrived, then swelling subsided. Then when they got home she had vomiting and diarrhea. All symptoms lasted about 5 hrs. Vomiting and diarrhea continued into 2nd day, then after that everything completely resolved. Next day she called the VA to report what happened, she was advised to have come back in. Symptoms: palpitations, throat and face swelling vaccine administration time: 11:00am symptoms started: 11:01am symptoms ended: next day at 6pm
40 2021-07-01 feeling jittery, tremor, burning sensation burning sensation through my body; shakes; jitteriness; lightheaded; exhaustion; injection site redn... Read more
burning sensation through my body; shakes; jitteriness; lightheaded; exhaustion; injection site redness and soreness; injection site redness and soreness; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL9264 and Expiration date: unknown), via an unspecified route of administration, in left arm on 07Feb2021 (at the age of 40-years-old) as dose 2, single for Covid-19 immunization. Facility where the most recent covid-19 vaccine was administered was hospital. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. Historical vaccination included dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL3249 and Expiration date: unknown), via an unknown route of administration, in left arm on 17Jan2021 at 09:30 (at the age of 40-years-old) as dose 1, single for covid-19 immunisation and experienced injection site irritation. Patient had no allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 07Feb2021 (at 09:45), the patient experienced after 2nd dose burning sensation through her body followed by shakes and jitteriness and lightheaded. Then exhaustion. 2 days later still had injection site redness and soreness. The case was assessed as non-serious. It was reported that " Was treatment received for the adverse event: Unknown". Outcome of the events was resolved on an unspecified date in Feb2021. Follow-up attempts are completed. No further information is expected.
40 2021-07-04 speech disorder Presented to hospital on 6/19 with severe frontal headache, mild speech changes, and motor deficits ... Read more
Presented to hospital on 6/19 with severe frontal headache, mild speech changes, and motor deficits without fevers, shortness of breath, chest pain, or neck rigidity.
40 2021-07-05 numbness, tingling Numbness and tingling head, foot, arm, fingers and face; fatigue; lightheaded ness; foggy brain; Num... Read more
Numbness and tingling head, foot, arm, fingers and face; fatigue; lightheaded ness; foggy brain; Numbness and tingling head, foot, arm, fingers; This is a spontaneous report from a contactable consumer(patient). A 40-year old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number ER8732), via an unspecified route of administration at Arm Left in MAR2021 at 40 years old at single dose for COVID-19 immunization. The medical history was Hypothyroidism and diagnosed with COVID-19. The concomitant medications were liothyronine sodium(CYTOMEL) for Thyroid and Synthesis. The patient was not pregnant. There was no other vaccine in four weeks. On 22Mar2021 the patient experienced Numbness and tingling head, foot, arm, fingers and face, Foggy brain, fatigue and lightheaded ness 6 periods in 3 months (beginning the day after my first vaccine). Two ER visits to rule out serious medical conditions, two MRIs, blood work, and 2 day hospital stay. All of the events resulted in Emergency Room Visit and Physician Office Visit. All of the events resulted in hospitalized from 2021 to 2021(duration of 2 days). The patient received the treatment Gabapentin for Numbness and tingling head, foot, arm, fingers and face. The patient received the second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EW0170822021), via an unspecified route of administration at Arm Left 18-APR-2021 11:15 at single dose for COVID-19 immunization. There was covid prior vaccination. The patient underwent lab tests and procedures, which included blood work Unknown result; MRI Unknown Result; MRI Unknown Result; PCR on 07Jun2021: Negative. The outcome of the events was not recovered.
40 2021-07-06 bell's palsy Dose #1: Just a sore arm Dose #2: Within 24 hours my left ear hurt like I was getting an ear infec... Read more
Dose #1: Just a sore arm Dose #2: Within 24 hours my left ear hurt like I was getting an ear infection. I just assumed it was allergies. Within 48 hours my left eye began stinging and hurting, as well as continuation of a left earache. Within 72 hours I noticed that me left eye blinking was delayed and not symmetrical with that of my right. On May 1st I went to the ER and was diagnosed with Bell's Palsy. I had total loss of muscle/nerve control to the left side of my face. It affected my speech, ability to eat, and ability to drink. I was scared that I was having a stroke and went to the ER.
40 2021-07-06 tingling, feeling hot, flushing Sudden extreme tachycardia up to 161 with hot/flushing feeling over my entire body and both arms exp... Read more
Sudden extreme tachycardia up to 161 with hot/flushing feeling over my entire body and both arms experienced paresthesia, had some shortness of breath - tachycardia remained between 100-125 with the hot/flushed feeling for about 6 hours and had mild tachycardia for 2 days after the initial spike. Went to the ER and waited to be seen for hours; over the next days to a month I followed up with my PCP, Cardiology, had ECHO, stress test, and 3 week heart monitor done. I experienced elevated HR and SOB with minor activties for 1-2 months after the initial injection and occurrence.
40 2021-07-06 speech disorder, pain in extremity, tremor Symptoms Shot January 10 Sore arm Fever headache cough 7 days Brain fog persistent headaches No pe... Read more
Symptoms Shot January 10 Sore arm Fever headache cough 7 days Brain fog persistent headaches No period February lymph nodes under the armpit 3 days Persistent headaches No period March Persistent headaches No period One day of blood clots Er visit for upper gi severe pain ct clear April Headaches worsening No period May Headaches worsening No period Tremors in right hand ER VISIT migraine meds given no change June Headaches worsening No Period Stuttering and speech difficulty 6 10 15 16 dizziness and vomiting 6 10 difficult with walking Pain behind eyes moving side to side and up and down 6/19 carbonated sodas are flat can?t feel Carbonation in my mouth July Worsening head pain Consistent stutter Intermittent problems with walking July 5th hard time gripping items and equilibrium off. Treatments. EEG shows diffuse brain dysfunction, VERS shows optic nerve information. Intercranial pressure increased. No changes still testing
40 2021-07-07 muscle twitching, involuntary muscle movements event 1. dry eyes and eye squinting treatment1.1: Loteprednol Etabonate. treatment1.1 period: 5/24-... Read more
event 1. dry eyes and eye squinting treatment1.1: Loteprednol Etabonate. treatment1.1 period: 5/24-5/31 outcomes: stopped using it due to feeling heavy in eye lid treatment 1.2: Xiidra treatment 1.2 period: 5/12-7/4 outcomes: stopped using it due to no effects and lots of side effects treatment 1.3: punctual plugs treatment 1.3 period: inserted on 5/12 outcomes: no obvious effect treatment 1.4 doxycycline treatment 1.4 period: 6/25-7/3 outcomes: stopped using it because of dry mouth 2. sucking and fish-like movements of the mouth, facial twitching, difficulty to drive since I can hardly open my eyes while driving, difficulty to do daily activities. suspect Meige syndrome No treatment yet
40 2021-07-07 pain in extremity Extreme body and joint pain three days after vaccine. Throbbing in legs, aching in arms, hip and sho... Read more
Extreme body and joint pain three days after vaccine. Throbbing in legs, aching in arms, hip and shoulder pain. Doctor prescribed pain medication and muscle relaxer to try to help. I then had a leg ultrasound, hip MRI and was put on a steroid pack for inflammatory response. My psoriasis which was dormant flared and I have had to see the dermatologist who will be ordering blue light therapy to control the inflammation. Currently on anti-inflammatory medication to help with the pain however I haven't been able to workout or be as physically active as I was prior to the second dose vaccine.
40 2021-07-08 pain in extremity Pain in the outer arm where the shot was given; Pain under the arm of the arm/in the armpit area whe... Read more
Pain in the outer arm where the shot was given; Pain under the arm of the arm/in the armpit area where the shot was administered; Fatigue; This is a spontaneous report received from a non-contactable patient. A 40-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration on right arm on 23Mar2021 at 10:30 (at the age of 40-year-old) as a single dose, for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Prior to vaccination the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, the patient experienced pain in the outer arm where the shot was given (pain in arm), pain under the arm of the arm/in the armpit area where the shot was administered (armpit pain) and fatigue. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events pain in arm, armpit pain and fatigue were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-08 pain in extremity The second injection hurt really badly immediately, as I was getting the injection and in the moment... Read more
The second injection hurt really badly immediately, as I was getting the injection and in the moments after and continued hurting badly for almost two weeks after, and now I have this pain that feels like an overuse injury in my shoulder and it radiates into my collarbone and neck area and sometimes down into my arm as well. I can?t sleep or carry bags on that side. I don?t have insurance so I don?t know who to see about it but I?m worried that the needle missed the muscle and hit something in my shoulder.
40 2021-07-08 pain in extremity Headache; sore arm; fatigue; developed shingles; This is a spontaneous report from a contactable con... Read more
Headache; sore arm; fatigue; developed shingles; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6206) via an unspecified route of administration in the right arm on 13Mar2021 at 12:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included ibuprofen (ADVIL), multi vitamin (MANUFACTURER UNKNOWN), sambucus nigra (ELDERBERRY), sertraline hydrochloride (ZOLOFT) and clarithromycin (CLARITIN), all for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6200) via an unspecified route of administration in right arm on 20Feb2021 at 12:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 20Mar2021 at 00:00, the patient had experienced headache, sore arm, fatigue and developed shingles 9 days after on an unknown date in Mar2021. The patient underwent lab tests and procedures, which included COVID-19 virus test via nasal swab on 23Mar2021 and the result found to be negative. The patient was treated with Valtrex for the reported events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events headache, sore arm, fatigue and shingles was not resolved at the time of report. No follow-up attempts are needed. No further information expected.
40 2021-07-08 tenderness lump near my left collar bone; tender to the touch; This is a spontaneous report from a contactable ... Read more
lump near my left collar bone; tender to the touch; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247), via an unspecified route of administration in the left arm on 24Mar2021 at 09:45 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as no. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247), via an unspecified route of administration in the left arm on 03Mar2021 at 09:45 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 06:00, the patient experienced lump near left collar bone and was tender to the touch. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the lump near left collar bone and tenderness was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-09 pain in extremity Walking and was feeling fine but towards evening pain in my right Achilles tendon ankle on heel. Pai... Read more
Walking and was feeling fine but towards evening pain in my right Achilles tendon ankle on heel. Pain got worse. I contacted doctor's office; put me in a cam boot but then it was feeling worse, and I went again, and he did an MRI, and I was in that for eight weeks. I was in the boot until the end April. From the 10th and then 8 weeks beyond that. Past week I was walking, and I think I have a tear in my left calf now, in my other calf, and it's still sore. I'm assuming I tore something. It's a little swollen and I'm limping around. I am going to continue to watch it. I had lab work done and all of that seemed fine. No inflammatory markers showing. They are watching me for any kind of auto-immune condition because I've had positive and negative ANA tests and Rheumatoid Factor results; will be high at times and then it goes back to normal, it fluctuates. So, they are watching it. I'm still sore on the left calf. Note: In May, I think, I had the Gardasil vaccine; the third one of the series, need to confirm the exact date.
40 2021-07-10 weakness My arm swelled like a big knot, bruised and hardened. I felt woozy and out of it like not alert for ... Read more
My arm swelled like a big knot, bruised and hardened. I felt woozy and out of it like not alert for 3 days already i would also sweat and feel weak like passing out, i had fever spikes of 100 degrees for 3 days and had to take tylenol plus had headpain, confusion. I felt nsuseated. I had flu chills in the first 24 hours and aches for 3 days the wooziness and disoriented effects lasted 5 days and came in waves. I took tylenol and stayed home from work
40 2021-07-11 hot flush Fever, Chills/Hot Flashes, Headache, Fatigue
40 2021-07-11 tingling a slight vibration feeling in my legs.; This is a spontaneous report from a contactable consumer (pa... Read more
a slight vibration feeling in my legs.; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non pregnent female patient received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 09:15 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. Concomitant medication(s) included ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient do not have allergies to medications, food, or other products. Previously patient received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection) dose 1 via an unspecified route of administration, administered in arm left on 26Jan2021 14:15 (Batch/Lot Number: EL9263) for covid-19 immunization. The patient experienced a slight vibration feeling in her legs on 16Feb2021 10:00. After getting home from vaccine, she noticed a slight vibration feeling in her legs. She had noticed this feeling since having the vaccine through her body. It was almost 1 week since having the vaccine. She noticed it when standing still, laying down, etc. it felt like they were standing on a floor that was vibrating slightly. It does not caused pain but was worrisome and not sure why it was happening. It very annoying feeling to have all the time. It comes and goes. The sensation was not painful but was worrisome. She actually filed out the thing while she was waiting, but she thought she would talk to someone. She wanted to know if they give feedback. The symptom she thinks she had had ever since she got the second shot was a mild vibration in her body. Obviously, she doesn't hear that as a normal symptom of the COVID vaccine. Caller clarified that she was looking for information about mild vibration in her body after the second dose of the COVID vaccine. Caller confirmed that there had not been a new event since she reported her experience. She enquired that is this something that has been reported before. The patient referred to HCP for treatment if symptom persists. No treatment was received for the event.The outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.
40 2021-07-11 tremor After the first injection the same night around 11pm I had extreme nausea and diarrhea that lasted t... Read more
After the first injection the same night around 11pm I had extreme nausea and diarrhea that lasted through the night. After the second injection my side effects were more extreme. That same night around 10pm I had drowsiness, so I went to bed. Shortly after I had nausea and chills. The chill were causing my body to shake severely even though I was covered in blankets. Then the body pain kicked in. It was so bad I couldn?t even walk, and just switching positions in bed brought me to tears. In the morning I was running a fever of 100.2 and the body aches remained. My fever lasted 48hrs as well as the body aches. Overall, I felt so bad I contemplated going to the hospital.
40 2021-07-12 fibromyalgia I was 40 years old and received both doses of the Pfizer vaccine and not only has my body hurt more ... Read more
I was 40 years old and received both doses of the Pfizer vaccine and not only has my body hurt more with my fibromyalgia, but I have been in a CONSTANT flare since the shot. I have had Interstitial Cystitis since age 23 and the only thing I did differently was to take the covid vaccine, not realizing it is gene therapy and an mRNA vaccine. I usually have no flares in the summer. Ragweed and spring allergies tend to mess me up, but summer is usually pretty good.
40 2021-07-12 tingling, muscle spasms Monthly cycle has been heavy bleeding, defibrilating cramps, and unpredictable. Spotting moments aft... Read more
Monthly cycle has been heavy bleeding, defibrilating cramps, and unpredictable. Spotting moments after the vaccine. Chest pain, and pins and needle sensation in legs.
40 2021-07-12 tingling, pain in extremity, nerve pain, numbness and pain in extremities, tenderness, burning sensation My left hand became swollen for about 4 days starting on the day of the first injection. Once that s... Read more
My left hand became swollen for about 4 days starting on the day of the first injection. Once that subsided, my entire arm, hand, and fingers felt sprained and bruised. And my nerve endings in my palm and fingers were firing constantly. That lasted for a few weeks. Once the "sprained" feeling subsided and I had more mobility in my art/wrist, the nerve pain remained. I received this injection 4/28/21; it's now 7/13/21 and I still have nerve pain in my forearm, hand and fingers that moves around/is worse in some areas than others at different times. It feels like a pins and needles sensation, sometimes burning, sometimes aching, sometimes like it feels when you hit your funny bone. I have been told I have peripheral neuropathy. I don't know if it's from the vaccine itself or if the person who administered it hit a nerve.
40 2021-07-14 feeling hot, flushing 7/8/21: Around 4:30pm became flushed and hot. 30 minutes later minor wheezing followed by itching on... Read more
7/8/21: Around 4:30pm became flushed and hot. 30 minutes later minor wheezing followed by itching on neck and upper back. Took 2 Benedryl and symptoms resolved. 7/10/21: Began experiencing tightness in chest, difficulty taking a deep breath. Asthma hasn't been this bad in well over a decade. Albuterol provided only short term relief. Benedryl provided more relieve and for longer period but symptoms persisted. 7/14/21: Met with doctor. Switched from Allegra to Zyrtec. Added Qvar on top of Symbicort. Will have checkin in a few days. If there's no improvement, the plan is to start prednisone.
40 2021-07-14 tingling, numbness The patient has stated that she has been having cases of minor swelling, puffiness, and slight numbn... Read more
The patient has stated that she has been having cases of minor swelling, puffiness, and slight numbness and tingling over the recent twelve days, following the first dose of the COVID vaccine. She reports having several different reactions to where she has swelling in her upper or lower lip, numbness near her cheek area, and slight puffiness under her left eye. Not all of these events occur at the same time, rather they seem to occur on seperate occasions. The sights of these events seem to rotate around the facial area as well. She reports that she has been self-medicating, taking chlorpheniramine 4 mg, as an over-the-counter oral tablet. This antihistamine medication appreas to help reduce the swelling and puffiness. An allergy specialist that she visited within the last week, also recommended that she continue to take that antihistamine medication. As per the current CDC recommendations, I have stated that it would be most appropriate for her to not receive the second dose of the COVID vaccine. She will continue to monitor her symptoms, and continue to take the antihistamine medication as she has been taking it previously.
40 2021-07-15 migraine I started with a fever and a headache about 3 hours after receiving the vaccine. I took Tylenol and... Read more
I started with a fever and a headache about 3 hours after receiving the vaccine. I took Tylenol and felt better. About 10 am that evening I had chills, I jumped in the shower to warm up my body which helped and I went to bed. Wednesday about mid day I became quite nauseated, dizziness and just did not feel well. I took benedryl that evening and went to bed. Thursday around mid- day again I continued to have nausea and dizziness, then I also started having chest tightness, I used my albuterol inhaler which is new to me for allergy induced asthma, which helped. Overnight Thursday into Friday I woke up in the night and had sweat through my clothes. I had the same symptoms carry on into Friday. Saturday I was beginning to feel better until mid afternoon I had a different chest discomfort and nausea and I reported to the emergency room they ruled out a cardiac event, gave me 2 baby aspirin and zofran and sent me home. Sunday I woke up with a terrible migraine I treated with alternating tylenol and ibuprofen for about 24 hours. Monday- Tuesday- Wednesday I just felt worn out, fatigued over all not well. Thursday I finally started feeling better and contiue dto feel better.
40 2021-07-15 pain in extremity I started without getting my minstrel cycle. From there I started having other symptoms...not using ... Read more
I started without getting my minstrel cycle. From there I started having other symptoms...not using the bathroom.... forgetting things...trouble swallowing...trouble sleeping. I went to doctor finally advising that it slowly started after my first shot and worsened after my 2nd. They tested me. I came back with hypo thyroid and enlarged thyroid and enlarged left ovary. I went to the dr the october before and was perfectly healthy with nothing. Now I have thyroid issues ...still have problems sleeping...still have one had one cycle since the shots.....put on 20pds!! and have occasional pain in the arm still.
40 2021-07-15 tenderness DVT left saphenous vein and left common femoral vein. Redness and tenderness inside of left thigh x... Read more
DVT left saphenous vein and left common femoral vein. Redness and tenderness inside of left thigh x 2 days. Got an ultrasound 1/29/21 that confirmed DVT. Treatment: eliquis x 3 months and for as long as I'm on tamoxifen. If discontinuing tamoxifen, daily aspirin recommended.
40 2021-07-16 tingling, tremor Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Medium, ... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling hands and face. Patient felt dizziness for approximately 30 minutes. She was laying flat on floor with feet elevated. EMT was called and she was transported to ER where she remained for 1 hour until symptoms resolved. Followed up with her about 6 hours later and she is feeling better but tired. she is going to contact her primary care physician
40 2021-07-17 numbness I was late getting my second shot; I was late getting my second shot; I got second shot yesterday an... Read more
I was late getting my second shot; I was late getting my second shot; I got second shot yesterday and my left side of my face feels a little bit numb; This is a spontaneous report from a contactable consumer (patient, self-reported). A 40-Years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: SA6780 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on an unspecified date (age at vaccination: 40 years), as a single dose for COVID-19 immunization. The patient's medical history included eczema. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not reported), via an unspecified route of administration, on 05Mar2021 (age at vaccination: 40 years), as a single dose for COVID-19 immunization and had throat got swollen, tightness, my lips became tingly, nausea, tired, and not feeling well/feeling ill. The patient reported that she got second shot yesterday and on 22Jun2021, her left side of her face feels a little bit numb almost like the Novocaine at the dentist was wearing off. It feels a little bit part of left part of her cheek. She stated it is little bit, it's very mild. She was late getting her second shot and that was okay right? Because they said even if you were late you could get the 2nd shot. Lab test included tested for Covid antibody antigen, she doesn't have the reports back. That was last week. Treatment received for event with motrin 600 mg, benadryl 50 mg on 22Jun2021 at 12:45 pm, motrin 200mg on 22Jun2021 at 10pm, benadryl 25mg on 22Jun2021 at 11pm. Outcome of the event I got second shot yesterday and my left side of my face feels a little bit numb was not recovered and for all other event, it was unknown. Follow-up attempts are needed. Further Information is expected.
40 2021-07-17 pain in extremity Leg was hurting a little bit; This is a spontaneous report from a contactable consumer (patient) rep... Read more
Leg was hurting a little bit; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0187) via an unspecified route of administration in right arm on 06Jun2021 in morning as 1st dose, single for Covid-19 immunization. Patients medical history was not reported. Patients concomitant medications included pantoprazole and she reported takes Levothyroxine sodium, Levoxine or something like that, it is 75. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. On 06Jun2021 patients leg was hurting a little bit faced the same day, she took the vaccine. Reporter stated, he was speaking on behalf of his wife. She took the Pfizer shot, she got the first shot, and she was supposed to go back on day of reporting, she went to get the second shot and they asked her if she had any symptoms and she said that her leg was hurting a little bit. Event was improved because they only hurt for one day. Patient did not receive any treatment for the event. The outcome of event was recovering at the time of reporting. No follow-up attempts are possible. No further information is expected.
40 2021-07-17 paralysis Vaccine given at 2 pm 10-pm - legs were weak and fell taking a shower 1 am ( 7/14)- got up to use th... Read more
Vaccine given at 2 pm 10-pm - legs were weak and fell taking a shower 1 am ( 7/14)- got up to use the bathroom and legs progressively more weak and fell again 3 am- unable to move from the chest down- could ?flick a toe ? but that was it . Essentially paralyzed 9:30am ( ish) Till I was able to get help and check into the ER . Was taking back within 5-10 minutes Was admitted under Neurology service and stayed for 3 days Getting 1000mg IV solumedrol, monitoring blood sugars, lab work, PT/OT 7/17/21- Discharged to home
40 2021-07-17 throat numbness Loss of feeling in throat; This is a spontaneous report from a contactable consumer, the patient. A ... Read more
Loss of feeling in throat; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the arm left on 30Mar2021 at 14:45 (at the age of 40-year-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the arm left on 09Mar2021 at 13:45(at the age of 40-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 15:00, the patient experienced loss of feeling in throat. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse event and included treatment with BENADRYL on an unknown date. The clinical outcome of the event loss of feeling in throat was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
40 2021-07-17 tremor, pain in extremity Some soreness on the left arm day of and the next day after the shot. 7/16 some muscle aches and rea... Read more
Some soreness on the left arm day of and the next day after the shot. 7/16 some muscle aches and really fatigued around 3:00p.m. On 7/17 fatigued, hand tremors and joint pain.
40 2021-07-18 numbness, tingling Body Aches, Fever, Chills, Headache, numbness/tingling in the legs and arms, Warm tingling and tight... Read more
Body Aches, Fever, Chills, Headache, numbness/tingling in the legs and arms, Warm tingling and tightness of the chest, legs were tingling and had a lump in left leg, High blood pressure.
40 2021-07-18 numbness Chest pain, shortness of breath, nausea, vomiting, and left arm numbness
40 2021-07-18 pain in extremity Swollen lymph node under right arm. My entire arm was sore to my finger tip it felt as if my circula... Read more
Swollen lymph node under right arm. My entire arm was sore to my finger tip it felt as if my circulation was being cut off in my arm and it lasted about 48hrs. My under arm is still swollen and sore. I did have all the other side affects, fever, chills, dizzy, muscle aches and fatigue.
40 2021-07-19 feeling cold, pain in extremity, muscle spasms Within 2 hours I could not keep my eyes open and had to go to sleep. I woke up the next morning and ... Read more
Within 2 hours I could not keep my eyes open and had to go to sleep. I woke up the next morning and my head was killing me. My glands in my neck were swollen, my ears hurt, my tongue was swollen and had sores on the sides of it. I was severely fatigued, running a low grade fever and could barely move my left arm. These symptoms lasted for a couple of days and then dropped off. Then, exactly one week later I woke up and could barely move my left arm. My lymph node under my armpit was swollen to the size of a baseball and was in excruciating pain. The injection site was also red and swollen and had a rash going down my arm as well. This lasted for about a week before going away. After the second dose, about 2 hours after receiving the shot, I had to lay down and take a nap. I got up about 2 hours later and was already feeling ill and running a low grade fever. I went to bed and woke up at 3:00 am in a ridiculous amount of pain. My whole entire body was cramping like I had not had water to drink in a week, then I was having sharp shooting stabbing pains throughout my whole body. My whole body felt like I had been run over by a bus. Every muscle hurt, I was sweating, freezing, running a temp, my head felt like it was about to explode. The lymph node in my left arm swelled up instantly and my arm hurt so bad I could not move it. I was in and out of sleep and when I would wake up I would have to change my clothes because they were drenched in sweat and having to lay a towel down on the bed because it was wet but I didn't have the energy to change the sheets. This went on for FOUR days. I was on the verge of going to the ER on day three but after being helped out of bed and into a hot bath, the pain in my body started easing up. I had COVID in March of 2020 and this second shot was ALMOST as bad as when I had COVID. The only difference is I was sick for about 4 weeks and my lungs were really bad when I had COVID. The shot did not affect my breathing.
40 2021-07-19 hot flush, burning sensation Headaches; hot flashes; dry eyes; burning sending under skin on location where received fillers smil... Read more
Headaches; hot flashes; dry eyes; burning sending under skin on location where received fillers smile lines, cheeks; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 09:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 10:15, the patient experienced headaches, hot flashes, dry eyes, burning sending under skin on location where received fillers smile lines, cheeks. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headaches, hot flashes, dry eyes and burning sensation was recovering at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-07-19 pain in extremity bright red rash; sore area on right arm; This is a spontaneous report from a contactable consumer, t... Read more
bright red rash; sore area on right arm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the right arm on 24Mar2021 at 20:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as "too long to list-can provide a list if contacted directly". The patient had history of known allergies to adhesives. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration on 03Mar2021 at 13:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation and cefprozil (CEFZIL) on an unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021, the patient firstly had noticed bright red rash and sore area on her right arm near the injection site, but it was very small and it became larger on 01Apr2021, measured approximately 17cm by 6cm in a parallelogram at the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of bright red rash and sore area on right arm were not recovered. No follow-up attempts are needed. No further information is expected.
40 2021-07-19 tingling, cold extremities, involuntary muscle movements chest started hurting; Fatigue; he couldn't move her mouth; her hands got real tight feeling; blood ... Read more
chest started hurting; Fatigue; he couldn't move her mouth; her hands got real tight feeling; blood pressure and heart rate was up/Elevated BP; couldn't breath; fast heart rate/heart rate and it was 140-145; bad dizziness/Lightheadedness; She had a pins and needles sensation in her fingers; her hands and mouth were frozen; her hands and mouth were frozen; fever of 100 degree F/Temperature elevation; headache; tired; anxiety attack; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9263), via an intramuscular route, administered in Arm Right on 09Feb2021 at 13:20 (at the age of 40-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient's historical vaccine first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL1283), via intramuscular route, administered in Arm Right on 19Jan2021 (at the age of 40-year-old) as single dose for covid-19 immunization. It was not provided that the patient was received any vaccine 4 weeks prior vaccination. On 09Feb2021 the patient experienced fast heart rate/heart rate and it was 140-145, bad dizziness/light-headedness, she had a pins and needles sensation in her fingers, her hands and mouth were frozen, her hands and mouth were frozen, fever of 100-degree F/Temperature elevation, headache, tired, blood pressure and heart rate was up/Elevated BP, couldn't breathe, Fatigue, he couldn't move her mouth, her hands got real tight feeling and on Feb2021 anxiety attack and on 12Feb2021 chest started hurting. She mentioned that she received the 2nd dose of the vaccine last Tuesday and experienced a fast heart rate, really bad dizziness within 5 minutes. She had a pins and needles sensation in her fingers and her hands and mouth were frozen. She went to the EMS and her symptoms were addressed. She went home but experienced it again and went to the walking clinic with a fever of 100-degree F. Her doctor said that it may be related to the vaccine. On Wednesday she said that she had a headache and was tired. On Thursday she said that she may had an anxiety attack with a heart rate of 145. Blood work was done, and it said that there was no evidence of clotting. The EKG revealed that her heart rate won't drop, and it was hurting her chest and her heart as it was beating fast. She has been prescribed with anxiety medications. She was asking if this was a common side effect because her doctors don't know. She reported she had her second COVID-19 Vaccine dose on 09Feb2021 at 1:20PM, and she has had side effects ever since. She said the side effects have her scared. She said she still has a rapid heart rate in the 90s. Reporter Type: Patient Reported 5 minutes after receiving her second COVID-19 Vaccine dose she got lightheaded and dizzy. She said she told one of the staff at the COVID-19 Vaccine facility that she thought she was dizzy and didn't feel right. She said she was moved to a private room at the COVID-19 Vaccine site. She said the staff put things on her chest and stomach and checked her blood pressure. She said the staff told her that her blood pressure and heart rate was up. She said she doesn't remember what her blood pressure or heart rate was at the time. She said a staff member taking care of her asked her if she was nervous. She said she told the staff member she had nothing to be anxious about. She said she told the staff member that she knows what the common COVID-19 Vaccine side effects are, and that she had gotten over any fear of needles a long time ago. She said she was fine before she got her second COVID-19 Vaccine shot. She said 5 minutes after getting the second COVID-19 Vaccine shot, she gets dizzy and lightheaded out of nowhere. She said her mother had died of breast cancer in Dec2020, and she had a Xanax prescription from during that time. She said she took a 1/2 of Xanax to see if the Xanax would help her blood pressure and heart rate. She said after a half hour had gone by, she got a pins and needles feeling down her arms. She said her blood pressure and heart rate were still up, and she could feel her heart beating in her chest. She said while she was still being attended to by the COVID-19 Vaccine facility staff member, and EMS person came in, and said 3 more people were down from that vaccine lot. She said the staff member asked if he could move her to another area outside of the private room she was in, and he told her he would have 2 cops keep an eye on her. She said she spoke to the 2 cops for a while, and then she called her director at work. She said she then called her husband, and her husband told her if she was feeling well enough to drive home. She said while she was driving home, her hands got real tight feeling, she couldn't move her mouth, her heart was hurting because her heart was beating so fast, and she couldn't breathe. She said she had to pull her car over, and have her husband get her. She said she went to the walk-in clinic at her work, and when her temperature was checked, it was 100 degrees. She said the doctor at the walk-in clinic told her she was having a reaction to the COVID-19 Vaccine. She said she got a headache that evening, and her breathing, blood pressure, and heart rate hadn't dropped. She said the next day she still had a headache, but she didn't want to take off from work. She said everyone she works with whom got the COVID-19 Vaccine had a fever, body aches, and a headache, and took off the next day from work. She said she had an episode at work that afternoon where she couldn't breathe, and her chest started hurting. She said someone checked her blood pressure, and heart rate and it was 140-145. She said she went to her doctor yesterday, and he did and EKG and told her she had an elevated heart rate. She said her doctor drew blood to check for blood clots and to check for something in her blood vessels in her heart. She said her doctor told her it may be anxiety, and for her to take a Xanax. She said her doctor said he wants to see how she was in the next week and see if anything changes. She said her heart rate today has been between 90-95. She said her heart was beating so fast that it was making her chest hurt. She said she told her doctor the EMS staff member that checked on her after she got lightheaded and dizzy at the COVID-19 Vaccine facility told her he had the same thing happen to him. She said there seems to be a difference of opinion between the walk-in clinic doctor, and her doctor. She said the walk-in clinic doctor was saying she was having a reaction to the COVID-19 Vaccine, and her doctor was saying it was anxiety, and for her to wait a week. She said she doesn't want any damage to her heart. She said her doctor told her no one has died from getting the COVID-19 Vaccine. Thinks she was experiencing a side effect to the COVID- 19 Vaccine. She said her other colleagues from work had some of the same side effects after getting the COVID-19 Vaccine. She, her doctor, said the COVID-19 Vaccine side effects only last 48 hours. She said Dr. was only telling her that because that was what was said about the COVID-19 Vaccine. She said was a younger doctor and doesn't know anything about the COVID-19 Vaccine. Reported she doesn't want to wake up and have to go to the emergency room because there was something wrong with her heart caused by the COVID-19 Vaccine. Treatment: Reported her doctor gave her allergy pills, clarified as Cetirizine. She said the Cetirizine was dispensed in a pharmacy bottle and she did not have the NDC, Lot, and Expiration Date. Reported her doctor also prescribed Naproxen 500mg for her headache. She said she did not have the Naproxen NDC, Lot, and Expiration Date. She said she did not take any of the Naproxen 500mg prescription. She said the doctor had given her a shot of Toradol when she was at the doctor's office. She did not have the Toradol NDC, Lot, and Expiration Date. Caller didn't have Xanax NDC, Lot, and Expiration Date to provide during call. Reported she doesn't take any medication unless she has to. Reported her doctor doesn't know why her heart rate was up. She said she was scared that she might have damage to her heart. Caller stated she had to pick up her daughter. Reported no one has any idea what was going on with her. She said her blood pressure didn't go up today, and she has been checking her heart rate. She said yesterday morning her heart rate was up there and then her heart rate subsided. She said she doesn't want any damage to her heart. Caller stated at the COVID-19 Vaccine administering site told her he thought he was going to die after he got his COVID-19 Vaccine. No further details provided. Reported her symptoms improved from yesterday, but she still has a headache. She said she has fatigue that started on 09Feb2021 and has stayed the same since that time. She said her heart rate today has been between 90-95. She said her heart was beating so fast that it was making her chest hurt. The patient underwent lab tests and procedures which included blood pressure measurement: blood pressure was up on unspecified date, blood test: no evidence of clotting on unspecified date, body temperature: 100-degree Fahrenheit on unspecified date, electrocardiogram: elevated heart rate on 11Feb2021, heart rate: 145 on unspecified date, heart rate: 140-145 on 11Feb2021 and heart rate: 90-95 on 12Feb2021. Patient not visited to emergency room for the events, visited to physician's office. Therapeutic measures were taken as a result of the events. The outcome of the events headache and fatigue was not recovered all others were recovering. Follow-up attempts completed. No further information expected.
40 2021-07-20 weakness extreme weakness; lightheaded; This is a spontaneous report from a non-contactable consumer, the pat... Read more
extreme weakness; lightheaded; This is a spontaneous report from a non-contactable consumer, the patient. A 40-years-old adult non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included ethinylestradiol, etonogestrel (NOVARING), escitalopram (MANUFACTURER UNKNOWN) and valaciclovir (VALACYCLOVIR); all for an unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient experienced extreme weakness and lightheaded. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events extreme weakness and lightheadedness were resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-07-20 burning sensation Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: Pt felt a burning s... Read more
Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: Pt felt a burning sensation right away and stated that their heart was racing. I checked BP several times and the range was between 130-158 / 70-90. Pt went to urgent care & MD monitored until BP & HR was normal. They are unsure if this was vaccine related or nerves. Pt was instructed to rest at home today & is feeling better but noted that she felt itchy when she first woke up this AM but it has since passed.
40 2021-07-21 burning sensation, numbness, tingling Patient calling for Chronic COVID-19 Vaccine, Arm Pain, and Skin Problem (burning senstion- upper ex... Read more
Patient calling for Chronic COVID-19 Vaccine, Arm Pain, and Skin Problem (burning senstion- upper extremeties ) Symptoms started x1 month. Symptoms include: Received covid-19 vaccine. Patient has had a burning sensation since in arm since vaccine. States sensation has been spreading to the rest of her body. Patient Has not attempted treatment at home.. Pertinent negatives include: Afebrile. HISTORY OF PRESENT ILLNESS Patient is a 41 y.o. female who presents regarding a potential concern for an adverse reaction to the COVID-19 vaccine. Second Dose in Series: Vaccine was obtained from the clinic/location: on the date of: May 14th and approximate time of 2:30 Vaccine was administered to patient's: Right Deltoid Vaccine manufacture was: Pfizer No Previous Reactions to other immunizations Known COVID Exposure since receiving vaccination?: No Patient notes the following symptoms: Headache, Localized injection site pain and Myalgias Patient is a 41-year-old female presenting with multiple different symptoms post COVID-19 vaccine. Patient reports that has any burning sensation in her vaccine arm. She reports that it almost feels like it is on fire or sunburn. Patient reports that at times the sensation travels to different parts of her body. She also reports that she had neck pain, Back pain, and upper chest discomfort. That time she reports that she has some numbness and tingling bilateral to her upper extremities. She denies any weakness. She denies any level of consciousness changes. She denies any trauma. She does not a family history of stroke or neurological problems. She also reports that she has had a change in her menstrual cycle. She reports that she is had 2 menstrual periods in the month of May and also in June. She also reports mild headache. She also reports that her eyes seem a little dry and feels as though her vision may be getting worse. 1. Adverse effect of vaccine, initial encounter At this time due to multiple different neurological symptoms and unable to do a good thorough neuro exam I would like her to be seen in person for further evaluation. Patient was educated on worsening symptoms and reasons to go to the emergency room right away such as any signs of the stroke which we discussed speech changes, numbness or tingling down one arm. Patient was agreeable to plan of care and is going to reach out to her primary care doctor. Called PCP office to let them know my recommendation for appointment as soon as available This visit was completed via health visit and 11-20 mins was spent as part of care with patient.
40 2021-07-21 discomfort, pain in extremity Night of injection I nearly fainted-very odd experience. It was awful. Next day was 101 fever, but a... Read more
Night of injection I nearly fainted-very odd experience. It was awful. Next day was 101 fever, but as expected from vaccine reactions. Two days later extreme itching all over that lasted about a week. My scalp still itches daily seven weeks later. At about two days also my second toes on both feet (closest to my pinky toes) starting hurting. Next day my second finger on my left hand (closest to my pinky finger) starting hurting. Those still bother me but not as intense. In those next few weeks, I had heart flutters and general fatigue. The heart flutters weren't bothersome. At around July 2nd/4 weeks post second vaccine, I got intense stabbing pains in my chest area. So bad that if I didn't currently have bad health insurance, I would have gone to emergency room. I had the stabs of pain the next evening too. Fatigue worsened since those initial stabbing pains and has not been my usual normal since. Messaged doctor. He said he had a couple other patients wtih same issue and theirs went away. Heart has felt heavy since. It did seem to get better for about a week and then came raring back and had more stabbing pain episodes for a few days. ONe of which was when i was just simply taking my dog on a walk (not laying down which usually provokes it) It is worst when I am laying on my left side or laying back. Sleep was miserable for a week as I had to prop myself up on three pillows to even get remotely comfortable. I haven't been able to do anything that seem to get my heartrate over 100. I notice the extra heaviness in chest hurts when I go on a lenthier walk. During all of this I had several times where I typically would have gone directly to Emergency Room. I didn't go because of my bad health insurance currently from losing my job in last year. So please don't lower the severity of it because I didn't go to the emergency room. I have chronic condition, but my heart has never been effected/never had heart issues.
40 2021-07-21 hot flush Lack Of Apeptite; Hot Flash; Severe Diarrhea; Fever; Chill; Extreme Exhaustion; This is a spontaneou... Read more
Lack Of Apeptite; Hot Flash; Severe Diarrhea; Fever; Chill; Extreme Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8732) via an unspecified route of administration in the left arm on 30Mar2021 at 17:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 16:30 the patient experienced lack of appetite, hot flash, severe diarrhea, fever, chill and had extreme exhaustion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event lack of appetite, hot flash, severe diarrhea, fever, chill and extreme exhaustion were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-21 pain in extremity, weakness The evening of my 2nd vaccine, I had a 103 fever that lasted 2 days. I treated this with Tylenol. Si... Read more
The evening of my 2nd vaccine, I had a 103 fever that lasted 2 days. I treated this with Tylenol. Since then, I have experienced fatigue. 2 weeks later I woke up about midnight to shooting pains down both arms. This lasted about 5 minutes and then stopped. I didn't think anything of it at the time or linked it to the vaccine. Since that first time I have had that experience 3 more times in the middle of the night. I also have noticed vision changes in my left eye. As of now my fatigue has gotten better, but I am not back to my normal energy level.
40 2021-07-21 pain in extremity, night sweats Muscle aches; Chills; Severe headache; Night sweats; Arm hurt more than normal; This is a spontaneou... Read more
Muscle aches; Chills; Severe headache; Night sweats; Arm hurt more than normal; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the right arm right on 01Apr2021 at 09:00(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. Concomitant medications included ethinylestradiol, norethisterone acetate (ESTROSTEP) from an unknown date for birth control. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 20:30 the patient experienced chills, severe headache then night sweats and at night the arm hurt more than normal. On 02Apr2021 the patient experienced muscle aches. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event chills, headache, night sweats, arm hurt more than normal and muscle aches was not recovered. No follow-up attempts are needed. No further information is expected.
40 2021-07-21 pain in extremity Sore Left arm; significant fatigue; general malaise; temperature of 100.6; This is a spontaneous rep... Read more
Sore Left arm; significant fatigue; general malaise; temperature of 100.6; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 09:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included traumatic brain injury and major depression. The patient had drug allergy to Lexapro. Concomitant medications included fluticasone propionate (FLONASE), guaifenesin (MUCINEX), loratadine (CLARITIN) and vitamin d nos (VITAMIN D), all for unknown indications from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 13:30, the patient experienced sore left arm, significant fatigue, general malaise and temperature of 100.6. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of pain in left arm, fatigue, general malaise and low grade fever was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
40 2021-07-22 pain in extremity, nerve pain Within 2 hours of receiving the vaccine i had to leave work, abdominal pain, headache, exhausted, na... Read more
Within 2 hours of receiving the vaccine i had to leave work, abdominal pain, headache, exhausted, nauseated, neck pain. over the next weeks before my second dose, pain began to be all over, lots of nerve pain shooting down my legs. it got slightly better by the time i received my 2nd dose on May 20, 2021 BioNtech/Pfizer Lot# ER8736 also administered at a workplace clinic. within an hour the above symptoms came back stronger than before. I have not been able to work since. in addition to the above symptoms i have started getting dizzy, eyes hurt, and exhausted is putting it mildly. The beginning of July I started having memory issues.
40 2021-07-22 pain in extremity after the vaccine, began to be nauseous,; rumblings in my stomach; diarrhea; severe tiredness; sligh... Read more
after the vaccine, began to be nauseous,; rumblings in my stomach; diarrhea; severe tiredness; slight headache; slight pain or stiffness on left arm; slight pain or stiffness on left arm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 hours (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy, metal allergy and the patient was allergic to sulfur and sulfate. The patient did not take any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 09:30 hours, after the vaccine, the patient began to be nauseous and had rumblings in the stomach, diarrhea, severe tiredness, slight headache and slight pain or stiffness on the left arm from the shot. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events nauseous, rumblings in the stomach, diarrhea, severe tiredness, slight headache and slight pain or stiffness on the left arm were resolving at the time of report. No follow-up attempts are possible. No further information is expected.
40 2021-07-23 slurring, impaired body coordination Persistent moderate to severe headache, fever and myalgia immediately following second vaccination p... Read more
Persistent moderate to severe headache, fever and myalgia immediately following second vaccination progressing over days to neck stiffness, nausea and vommitting, personality change and irritability, ataxia involving dysarthria, extremities and gait leading to hospital admission on 6/19/21
40 2021-07-25 muscle spasms Muscle spasms in my back and left/right torso. Now, in my bladder too.
40 2021-07-26 facial paralysis, tingling I have a weird tightening on the right side of my face. My right eye lid is droopy all the time and... Read more
I have a weird tightening on the right side of my face. My right eye lid is droopy all the time and the right corner of my lip always pulls up, its kind of the opposite of bells palsy and the mornings are much more prominent. I have had occasional chest pain and R arm tingling when this first started. My vision is fine but my eye is very irritated and watery.
40 2021-07-26 feeling cold, weakness, feeling hot, tingling, numbness 2-3 days after 1st dose given on 5/22/21: heart palpitations and chest pain/pressure 12 hours after ... Read more
2-3 days after 1st dose given on 5/22/21: heart palpitations and chest pain/pressure 12 hours after 2nd dose given on 6/12/21: numbness/cooling feeling in lower extremities (lower legs/feet), hot/tingly hands, feet/toes, weakness and muscle stiffness in both legs, hot/cool feeling in upper legs, continued heart palpitations and chest pressure
40 2021-07-26 feeling cold 102 fever (1-2 days), purple nails (1day), freezing feeling (3 days), chills (3days), heart palpitat... Read more
102 fever (1-2 days), purple nails (1day), freezing feeling (3 days), chills (3days), heart palpitations (3 days), aches (3 days), skin soreness (3 days), fatigue (1week).
40 2021-07-27 weakness Arm was very hot to the touch at the injection site; Sporadic low grade fever; No energy.; This is a... Read more
Arm was very hot to the touch at the injection site; Sporadic low grade fever; No energy.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161), via an unspecified route of administration in the right arm on 25Apr2021 at 13:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the right arm on 30Mar2021(at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 at 13:00, the patient reported that her arm was very hot to touch at the injection site (vaccination site warmth) for more than four days at the time of reporting. On 26Apr2021 at 13:00, the patient also experienced sporadic low-grade fever and she reported that she had no energy. The clinical outcome of all the events arm was very hot to touch at the injection site (vaccination site warmth), sporadic low-grade fever and no energy were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-27 numbness, tremor Shaking and numbness in my legs for more than six days; Shaking and numbness in my legs for more tha... Read more
Shaking and numbness in my legs for more than six days; Shaking and numbness in my legs for more than six days; A paralytic feel; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in Arm Left on 15Apr2021 15:00 (Batch/Lot number, Expiry date was not reported and Age at the vaccination: 40-years-old) as single for covid-19 immunization. The patient's medical history and past drugs reported as no. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19 was mentioned as no whereas since the vaccination, the patient had been tested for COVID-19 was mentioned as yes. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination was reported as No. On 16Apr2021 12:00 AM, the patient experienced major shakes throughout the body within 24 hours of the first dose. The shakes went away but had persistent numbness and shaking in the lower extremity of both her legs. A paralytic feel. After taking antihistamines, the side effects got better but still to this day had not gone away when going down a flight of stairs. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test (Nasal Swab) was negative on 26Jun2021. The outcome of events was not recovered. Information about lot/batch number was requested.
40 2021-07-27 pain in extremity, burning sensation Left arm soreness.; Red mark about the size of a dime around the injection site.; the injection site... Read more
Left arm soreness.; Red mark about the size of a dime around the injection site.; the injection site had a bit of a burning or stinging sensation; my arm was just sore; Menstrual spotting; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that. A 40-years-old female (Non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3248), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:00 as (At the age of 40-years) DOSE 2, SINGLE for covid-19 immunisation. Medical history included intermenstrual bleeding from an unknown date and unknown if ongoing patient have a recent history of spotting. No Allergies to medications, food, or other products. Concomitant medication included oxymetazoline hydrochloride (CLARITIN ALLERGIC); triamcinolone acetonide (NASACORT); desogestrel, ethinylestradiol (VELIVET); ascorbic acid, betacarotene, biotin, calcium phosphate dibasic, calcium stearate, chromic chloride hexahydrate, copper sulfate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, panax ginseng, pantothenic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, sodium molybdate, sodium selenate, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc oxide (CENTRUM ACTIVE); calcium carbonate, colecalciferol (VITAMIN D 2000) all are taken for an unspecified indication, start and stop date were not reported patient received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. No covid prior vaccination. No covid test post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination Patient did not been tested for COVID-19 Since the vaccination. No Allergies to medications, food, or other products were reported. The patient previously took first dose of BNT162B2 (Lot number: EN6203) on 03Mar2021for COVID-19 immunization. On 25Mar2021 10:30 patient experienced Left arm soreness. Red mark about the size of a dime around the injection. May be a half hour after the injection, the injection site had a bit of a burning or stinging sensation but that lasted a version short time. Then later in the afternoon patient arm was just sore. It was reported that the date when patient first became aware of adverse event was 25Mar2021. It was reported that On Mar2021 patient experience Menstrual spotting, starting sometime the day after or days after his second dose (I'm not sure of the exact timing in relation to my vaccination). It was reported that patient had recent history of spotting so didn't think much of it. However, the spotting has been consistent since then and grown increasingly heavier. It was reported that patient read an article today that heaver menstrual cycles or spotting may be a side effect of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. Reporter considered all event was not serious. Patient did not receive any tenement for the events. The outcome of event menstrual spotting was not recovered, and outcome of all other events was recovering. No follow-up attempts are needed. No further information is expected.
40 2021-07-27 pain in extremity Body aches/whole body is hurting; Running fever; Fatigued/tiredness; Arm hurting; This is a spontane... Read more
Body aches/whole body is hurting; Running fever; Fatigued/tiredness; Arm hurting; This is a spontaneous report from a Pfizer Sponsored Program Covax US Support. A contactable 40-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0198) via unspecified route of administration, on 12Jul2021 as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 13Jul2021 at 7:30 AM, the patient woke up with body aches and arm was hurting, running fever, tiredness fatigue and pains. The patient wanted to know if she can take Naproxen (ALEVE) or Paracetamol (TYLENOL) or aspirin for the pain. The outcome of the events unknown. Information on the lot/batch number has been requested. Additional information has been requested.
40 2021-07-28 weakness, muscle spasms Muscle spasm. Feeling week
40 2021-07-28 difficulty speaking 1104 -Vaccine administer IM in L arm. 1110- PT states to complain of having something in her throat.... Read more
1104 -Vaccine administer IM in L arm. 1110- PT states to complain of having something in her throat. Denies having any SOB, chest tightness, itching, and no hoarseness. 1115- PT is clearing her throat more and states that she feels like she has to keep clearing her throat more and started to have Hoarseness denies having SOB but states that she is having a harder time breathing when positioning her head in certain ways. 1118- Minimal facial swelling noted clearing throat more often pt continues to talk to staff. Denies having SOB or chest tightness. Doctor notified of pt's symptoms and instructed to give Epi-Pen NOW. Epi-PEn(Lot #0FM407 exp: 02/2022) administered to Left Thigh by LPN. Pt tolerated and continues to talk to staff. 1120- Doctor in Room evaluating patient. Doctor instructed to continue monitoring in room for the remainder of 30 minute wait and advised patient that she could return back to work since pt works in the hospital. PT voiced understanding. Pt continues to deny SOB and chest tightness. 1125- PT states that she can tell her throat is starting to feel better states that she doesn't feel like she has to continue clearing throat. Continues to communicate with staff and continues denying any SOB. 1130- PT continues to states that feels like she is improving. Facial swelling has gone down. Continues to communicate and denies having and SOB and chest tightness. 1135- PT's 30 minute wait is up and Pt continues communicating with staff. Denies SOB states that she feels somewhat better. Informed patient that she could continue to be monitored by immunizations RN but pt denies and verbalized that ''Dr. said I could go back to work''. Informed patient that if symptoms do not improve and if she starts to have SOB, difficulty swallowing, swelling in throat or tongue to seek immediate attention at the ER. Pt verbalized understanding and ambulated out of area.
40 2021-07-28 numbness patient reported that left leg was numb for a while immediately after receiving injection. Pharmacis... Read more
patient reported that left leg was numb for a while immediately after receiving injection. Pharmacist called patient again on Thursday, July 29 at which time reported no more problems that was experienced on 7/28/2021
40 2021-07-28 muscle spasms, tremor, facial pain, tingling, pain in extremity, numbness Effect On Ears - Evening of 3/13 tinnitus became louder and came in waves. - Tinnitus increased over... Read more
Effect On Ears - Evening of 3/13 tinnitus became louder and came in waves. - Tinnitus increased over the next couple of days to louder, constant, high-pitched buzzing, louder than TV and sound machine. - Feeling of fullness/pressure in/around ears. - Pain/discomfort in/around ear. - Sensitive to loud and high-pitched sounds, incl. kids, TV, music, dishes, loud talking. - Occasional popping in ears. - Occasional itching in ears. - Multiple sounds in ears (buzzing, tone), some times sound travels. - Tinnitus aggravated with exercise, hot showers, long exposure to sound (for example, low music, ocean waves, driving). Allergy shots cause flare ups with multiple symptoms (none of this happened prior to vaccine). - All symptoms above are new. Prior to vaccine I had a low baseline T that was easily ignored and only heard when silent. - Most symptoms eased after 10 - 12 weeks, but tinnitus (louder than pre-vaccine tinnitus) continues, as well as flare ups of all ear symptoms. Other Side Effects - GI: Significant loss of appetite, weight loss, stomach cramping, nausea, spit out food because of off taste, loose stool / diarrhea. All improved after 3 weeks. - Tremors / Shaking. Improved after 3 weeks. - Intense anxiety/depression began 3/14, including tightness in chest, difficulty breathing at times, increased heart rate, sleep disturbances, troubled thoughts. Eased after several weeks. Emotional upset from situation continues but at more appropriate level. - Pain/pressure (all over or shooting) in head and face, some times on one side of face, temples, forehead, base of neck. Eased after 1-2 months. - Prickly & numb sensations on face, similar sensation in toes and fingers a few times. Eased after 1-2 months. - Head fog. Eased after 1-2 months. - Fatigue. 3/26 Took walk and felt as though recovering from flu (heaviness in chest), unable to work out for 2 weeks, resumed since with less frequency & more modifications (continues like this). - 1-2 days after vaccine sore arm, aggravated arthritis and interstitial cystitis. - Other misc things experienced during the first 2-3 months post vaccine: neck and back pain, vision issues (trouble focusing, not as clear, floaters), hair loss (hair dresser noticed 3/23), increased pain in legs/veins, leg cramps.
40 2021-07-28 muscle spasms Right arm muscles have beenspasming all day; This is a spontaneous report from a contactable consume... Read more
Right arm muscles have beenspasming all day; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Er8734) via an unspecified route of administration in the right arm on 05Apr2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, gluten and dairy sensitivity. Concomitant medications included salbutamol (ALBUTEROL), vitamins (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC) all from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 09:00 about 24 hours after shot, the patient experienced right arm muscles spasming all day. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event right arm muscles spasming was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-28 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-p... Read more
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03May2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medication was not reported. The patient previously took cipro and strawberries. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 15:00 the patient experienced sore arm. The clinical outcome of the event sore arm was recovering at the time of report.. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-07-28 pain in extremity Sore arm; mild headache; strange dreams/disturbed sleep; occasional body aches; strange dreams/distu... Read more
Sore arm; mild headache; strange dreams/disturbed sleep; occasional body aches; strange dreams/disturbed sleep,; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 19:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, irritable bowel syndrome, GERD and gastritis, allergy to certain soy sauces but not all, and no other soy products. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX), levothyroxine sodium (EUTHYROX), loratadine (CLARITIN), ibuprofen (ADVIL), and doxycycline (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took Cephalexin (MANAFACTURER UNKNOWN), acetaminophen; hydrocodone (VICODIN), hydrocodone bitartrate; acetaminophen (LORTAB), hydrocodone bitartrate (NORCO) all from an unknown date for an unspecified indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 22:00 the patient experienced sore arm, mild headache, strange dreams/disturbed sleep, occasional body aches. Patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events pain in arm, headache, sleep disturbance, general body pain, abnormal dreams was resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.
40 2021-07-29 burning sensation nausea; vomiting; Burning sensation in feet; This is a spontaneous report from a contactable consume... Read more
nausea; vomiting; Burning sensation in feet; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the arm left on 01May2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included vitiligo. Concomitant medications included naltrexone hydrochloride, bupropion hydrochloride (CONTRAVE) from an unknown date for an unknown indication. The patient previously took LEXAPRO. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 16:30 in the evening, the patient experienced burning sensation in feet. On 04May2021 in the morning, the patient experienced nausea and vomiting. The clinical outcome of the event burning sensation in feet, nausea and vomiting was recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
40 2021-07-29 numbness Face became numb; This is a spontaneous report from a contactable consumer, the patient. A 40-year-o... Read more
Face became numb; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153) via an unspecified route of administration in the left arm on 17Apr2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8734) via an unspecified route of administration in the left arm on 27Mar2021 at 14:00 (at the age of vaccination 40-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 00:00 after two weeks of vaccination, the patient experienced face became numb. The clinical outcome of the event face numbness was not recovered. No follow-up attempts are needed. No further information is expected.
40 2021-07-29 pain in extremity toe continues to be red and swollen; Moderate/severe pulsing pain in left big toe; This is a spontan... Read more
toe continues to be red and swollen; Moderate/severe pulsing pain in left big toe; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: PFIZER EP7533) via an unspecified route of administration in the left arm on 03Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included toe injury on Sep2020 about 7 months ago. The patient had no known allergies. Concomitant medications included valaciclovir (VALACYCLOVIR) and PNR (unspecified) for unknown indication on unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 03:30 the patient experienced moderate/severe pulsing pain in left big toe and toe was red and swollen. It was reported that after the first night of extreme pain, the pain had subsided, but the toe continues to be red and swollen, which it was not prior to the vaccine. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events pulsing pain in left big toe and toe continues to be red and swollen were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2020-12-31 migraine Migraine x 4 days, nausea off and on x 3 days, itching arms and stomach x 2 hours, fatigue x 2days
41 2020-12-31 tremor Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followe... Read more
Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followed, observed by hospital staff for approximately 45mins then taken to ER, discharged with 90mins. Body aches and chills for 1-2days. dizziness, nausea, lightheaded for 4-5 days to follow.
41 2021-01-01 weakness Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and b... Read more
Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and balance was off and fell several times. Body aches and pain continued. 12/29/2020 at 8 pm had fever of 100. 12/30 fever 103f chills, slept almost all day loss of appetite. 12/31 no fever in the morning but acting different than normal. In after non could not tell my husband child?s name went to the ED where I was admitted for altered mental status. Discharge today with altered mental status, unspecified. Wife still has headache but normal level of consciousness.
41 2021-01-02 pain in extremity Sore arm, diarrhea, low grade fever. No treatment.
41 2021-01-03 flushing Approximately 5 minutes after her Pfizer vaccine, she felt like her throat was closing, flushed and ... Read more
Approximately 5 minutes after her Pfizer vaccine, she felt like her throat was closing, flushed and became diaphoretic.
41 2021-01-03 numbness, weakness, unresponsive to stimuli 12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, ... Read more
12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
41 2021-01-03 pain in extremity 12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early mo... Read more
12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early morning 12/21/2020 with moderate swelling of eyelids, face, lips that progressed over several hours before seeking care at Hospital ED. Received IV Benadryl and IV solumedrol. Prescribed oral prednisone dose pack to start next day. Symptoms mostly resolved by that evening.
41 2021-01-04 weakness I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on t... Read more
I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea, sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.
41 2021-01-04 burning sensation Itching that began localized to the injection site then spread all over the body. Feels like a burni... Read more
Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated itching that began localized to the injection site then spread all over the body. Felt like a burning sensation as well and an itch you can't scratch on 29Dec2020. Patient received Benadryl as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious. No follow-up attempts are possible; Information about batch/lot number cannot be obtained.
41 2021-01-04 hot flush 20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP ... Read more
20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.
41 2021-01-04 pain in extremity PT experienced itchiness and a sore arm on 12/23/2020. Developed hives on 1/5/2021 at injection site
41 2021-01-04 tingling Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ... Read more
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
41 2021-01-04 tremor, flushing 15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patien... Read more
15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patient anxious with these symptoms, feet shaking, felt heart "beating out of chest." Vitals gradually improved after benadryl over one hour. Sent home in care of husband. Will call tomorrow to check on patient and work with allergist on follow up vaccine before receiving.
41 2021-01-05 feeling hot TOUNGE SWELLING , FELT HOT 5 MIN AFTER POST INJUCTION. EPINEPHRINE GIVEN. ED VISIT
41 2021-01-05 flushing approximately 40 minutes after receiving the vaccine she became flushed, sweaty, dizzy. Then about 1... Read more
approximately 40 minutes after receiving the vaccine she became flushed, sweaty, dizzy. Then about 1 hour after vaccine she had a headache. I took her blood pressure, it was 158/83, Pulse 92, Respirations 20, not shortness of breath or respiratory difficulty noted. She laid down and continued to feel the same way after 2 hours post vaccination. Her husband picked her up and she went home to rest for the day. She was given instructions on when to seek medical attention and to call me later today to let me know how she is feeling.
41 2021-01-05 numbness, pain in extremity LEFT ARM PAIN AND NUMBESS IMEDIATELY POST VACCINATION.
41 2021-01-05 tingling, muscle twitching Immediately upon injection, tingling all over lasted for about less than 1 minute. Within 20 minute... Read more
Immediately upon injection, tingling all over lasted for about less than 1 minute. Within 20 minutes, tingling & facial muscle tightness around mouth. Twitching & facial mouth muscle tightness for about 4 days, diminishing each day. Vaccine was given Wed evening...finally Sun was little to none symptoms.
41 2021-01-06 burning sensation STARTING ON 12/24/2020 I developed burning and itching in both feet and along both deltoids. This ... Read more
STARTING ON 12/24/2020 I developed burning and itching in both feet and along both deltoids. This resulted in raised red pruritic wheals. I dosed Benadrly and used hydrocortisone cream to the area. Throughout the night, the rash appeared on both thighs, knees, back of the arms and along the back of the lower legs. Again raised pruritic wheals. It would improve with anti-histamine use. this continued until 12/29/2020. No persistent symptoms. There are no other changes in medicine, OTC medication use, no changes in foods/soaps etc.
41 2021-01-06 flushing Light headedness, skin flushing, syncope
41 2021-01-06 migraine site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and... Read more
site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and neck side of injection 24-96hrs. Treated with rest, advil, Benadryl
41 2021-01-06 pain in extremity, migraine 24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site... Read more
24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site, 48-96 nausea and diarrhea X24hrs, severe migraine, improving fatigue and hives. treated with rest, advil , and Benadryl
41 2021-01-06 pain in extremity Moderate joint aches and nausea. Started 18 hours after the vaccine and lasted 24 hours. Very sore ... Read more
Moderate joint aches and nausea. Started 18 hours after the vaccine and lasted 24 hours. Very sore right arm lasting about 72 hours.
41 2021-01-06 pain in extremity I Initially just had a sore left arm which felt better the next day. I woke up the morning after t... Read more
I Initially just had a sore left arm which felt better the next day. I woke up the morning after the Vaccine (1/6/21) and experienced right jaw pain which extend it to my ear which was worse during chewing and talking. Today on January 7 it is still present however seems milder
41 2021-01-06 pain in extremity Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine unt... Read more
Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine until about 3pm. Just typical arm pain. Moderate/Severe Fatigue set in around 3-6pm. Needed to nap from 4-5pm (extremely unsusual). Felt fine the next day. Moderate congestion in ears starting around the same time (6 hours after) and is persisting 30 hrs later. Feel like my ears will not pop and trying to yawn a lot. Also felt pretty bad sinus congestion starting at 7pm 12/21 (10 hrs after vaccine). Could not breathe through nostrils. Treated with sinus rinse and sudafed.
41 2021-01-06 pain in extremity Swollen clavicular lymph node, arm soreness, body aches. Taking tylenol and motrin for arm soreness... Read more
Swollen clavicular lymph node, arm soreness, body aches. Taking tylenol and motrin for arm soreness and body aches with improvement.
41 2021-01-06 tingling, feeling hot tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. ... Read more
tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. Heart rate was normal and skin felt normal to touch per medical staff. Patient denied shortness of breath, itching, no rash noted. Medical Authority, assessed patient, ordered Benadryl 25mg po. Patient intially denied need to take Benadryl, advised patient will need to be observed in emergency department. Patient did not want to go to the ED and instead took Benadryl 25mg po. Patient was monitored for 1 hour and 10 minutes, 55 minutes after Benadryl given. Patient felt ready to leave at this time.
41 2021-01-07 weakness, facial pain, pain in extremity Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatig... Read more
Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatigue
41 2021-01-07 cold sweat, discomfort Pfizer COVID-19 vaccine 1 (12/16/20) and 2 (1/5/21): Body aches, chills, fatigue, cold sweats, local... Read more
Pfizer COVID-19 vaccine 1 (12/16/20) and 2 (1/5/21): Body aches, chills, fatigue, cold sweats, localized discomfort
41 2021-01-07 feeling hot Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nur... Read more
Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nurse and at that time my watch was beeping afib.
41 2021-01-07 pain in extremity, weakness Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, b... Read more
Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, body aches and 102.0 fever. Fever lasted until day 3. Day 3-5 weakness, SOB with any exertion, fatigue. Had to call off work on day 3.
41 2021-01-07 pain in extremity, numbness and pain in extremities Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and la... Read more
Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and lasted until Saturday 12/26 - responded and improved with acetaminophen and ibuprofen; slight fatigue x 2 day and some slight chills
41 2021-01-07 pain in extremity chest tightness arm pain nausea diarrhea body aches fatigue lost work two days
41 2021-01-07 pain in extremity Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General ache... Read more
Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.
41 2021-01-07 pain in extremity body aches, fever, nausea, sore arm, up all night
41 2021-01-07 pain in extremity Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection ar... Read more
Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection arm.; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 28Dec2020 at single dose for COVID-19 immunization. The vaccine was administered at workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced axillary swelling, neck and hand pain in the injection arm on 29Dec2020. No treatment was given for the events. The outcome of the events was not recovered. Information on the Lot/batch number has been requested.
41 2021-01-07 tingling, numbness on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on da... Read more
on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; numbness in extremities; numbness and tingling in extremities, tingling in extremities more so in left upper extremity then left foot, then right hand; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration (Left arm) on 27Dec2020 14:30 at single dose for Covid-19 immunization. The patient's medical history included connective tissue undifferentiated (disorder), cervical radiculopathy, and Covid-19. No known allergies. Concomitant medications were unspecified; the patient received other medications within 2 weeks of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported numbness and tingling in extremities more so in left upper extremity then left foot, then right hand on 27Dec2020 (16:00). The patient also noticed slightly on day of injection then on day 3 (30Dec2020) after injection the patient had severe pain in left arm, weakness, and unable to raise arm at shoulder. The adverse events resulted in Emergency room/department or urgent care. The patient was treated with prednisone. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
41 2021-01-07 tenderness, hypersensitivity of all senses Ipsilateral anterior axillary swelling/lymphadenopathy, beginning ~24 hours after administration, li... Read more
Ipsilateral anterior axillary swelling/lymphadenopathy, beginning ~24 hours after administration, limiting L arm ROM x3 days. I was unable to lower my arm fully, and had significantly impaired movement due to pain and swelling. It is Improving as of report date, but still present (ROM essentially back to normal, only tender to palpation)
41 2021-01-08 weakness Fever, chills, weakness, myalgias, near syncope, increased heart rate.
41 2021-01-08 breast pain, pain in extremity Arm soreness (start: ~8 hrs post-vaccination, duration: 4 days) Fever & Chills (start: ~14 hrs post-... Read more
Arm soreness (start: ~8 hrs post-vaccination, duration: 4 days) Fever & Chills (start: ~14 hrs post-vac, duration: 1.5 days) Fatigue (start: ~24 hrs post-vac, duration: 1 day) Joint & Muscle pain (start : ~24 hrs post-vac, duration: 1 day) Headache (start ~24 hrs post-vac, duration: 8-12 hrs) Armpit/upper breast pain (start ~48 hrs post-vac, duration: 2 days)
41 2021-01-08 facial pain, nerve pain Nerve pain L face/head 9/10 pain gradual improvement over 7 days
41 2021-01-08 flushing Recipient came in c/o feeling "flushed". Denies asthma, allergies. lightheadedness. Color pink, no h... Read more
Recipient came in c/o feeling "flushed". Denies asthma, allergies. lightheadedness. Color pink, no hives ,uticaria, SOB. @0916 VS=88-116/60-22 lungs ausc. clear. @ 0920 stated she felt increase in HR. HR = 102 RR=24 116/70 . HR 104. No c/o nausea. color continues to remain pink, lungs clear. continued observation. at 0940 HR decreased to 71, which she states is normal for her. RR-16 115/80. States she feels "better". Given instructions to call 9-1-1 if s/s of anaphylaxis or if symptoms return to notify PCP.
41 2021-01-08 flushing Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flu... Read more
Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flushed feeling, heart palpitations, chest pain. See in urgent care at work, EKG showed ectopy. She was sent to the nearby emergency room, where she was monitored and given iv fluids, oxygen and tylenol. She is feeling better today one day later, and will have follow-up with cardiology. Vaccine administration may have set off underlying predisposition for PVC's, ectopy. Was aware of PVC's previously but well-controlled on diltiazem. Has now been switched to metoprolol.
41 2021-01-08 flushing c/o feeling flushed within 15 minutes of being vaccinated. Blotchy rash noted to chest and neck. No ... Read more
c/o feeling flushed within 15 minutes of being vaccinated. Blotchy rash noted to chest and neck. No SOB, no hives, no airway involvement. Transported to ED and al symptoms resolved upon arrival without intervention.
41 2021-01-08 tingling Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vacci... Read more
Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vaccine. Visited immediate care; received IV of Benadryl, Pepcid & Steroid.
41 2021-01-08 tenderness Rash & UrticariaPruritus Narrative: Developed urticaria (welt) over the vaccine site hours after re... Read more
Rash & UrticariaPruritus Narrative: Developed urticaria (welt) over the vaccine site hours after receiving vaccine. mild tenderness, then rash after several hours and became itchy. Employee is concerned about the level of protection (antibody titer produced)because allegedly given subcutaneous rather than intramuscular
41 2021-01-09 cold sweat 1/9 0230 bodyaches, chills, fatigue, fever, tightness in chest 1/10 2139-feels clammy and bodyaches
41 2021-01-09 feeling hot I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I ... Read more
I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I felt hot and faint. Ems was on site and monitored until ambulance arrived. I was given Benadryl immediately.
41 2021-01-09 flushing COVID-19 Vaccine (Pfizer) EL3302 Exo 05/21. Itching and redness (flushing) on chest, stomach, leg... Read more
COVID-19 Vaccine (Pfizer) EL3302 Exo 05/21. Itching and redness (flushing) on chest, stomach, legs occurring 10 minutes after receiving vaccine. Face was flushed red no itching. Initial BP 152/99 HR 84. Benadryl 50 mg PO and famotidine 20 mg PO administered. Patient reports similar reaction following the first dose of the vaccine - COVID-19 Vaccine (Pfizer) EL0140 Exp 03/21; itching resolved without medication the first time. Patient reports that this reaction is slightly worse than previous reaction to the first dose. At 3:48pm, BP 151/87 HR 82 O2=96%. Patient itching and redness on chest and flushing of face dissipating by 3:45pm. Patient clinically stable. Patient dismissed from clinic at 3:54pm.
41 2021-01-09 flushing Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced f... Read more
Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flushed feeling, heart palpitations, chest pain. See in urgent care at work, EKG showed ectopy. She was sent to the nearby emergency room, where she was monitored and given iv fluids, oxygen, and tylenol. She is feeling better today one day later, and will have follow-up with cardiology. Vaccine administration may have set off underlying predisposition for PVC's, ectopy. Was aware of PVC's previously but well-controlled on diltiazem. Has now been switched to metoprolol.
41 2021-01-09 numbness About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 m... Read more
About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 min and they did blood pressure and oxygen check. about 10 min in, I felt a little funny in my mouth, like a little bit of swelling, but never to the point of issue with breathing or swallowing. Numbness seemed to have subsided by the 60 minute time and I went home. No other symptoms.
41 2021-01-09 numbness HEADACHE, LIGHTHEADED, BODYACHES, LITTLE NUMBNESS IN THE RIGHT CHEEK B/P 152/93 PULSE 96 @ 12:55P... Read more
HEADACHE, LIGHTHEADED, BODYACHES, LITTLE NUMBNESS IN THE RIGHT CHEEK B/P 152/93 PULSE 96 @ 12:55PM PATIENT STATED SHE IS NOT GETTING WORSE @1:26PM PATIENT REFUSED EMERGENCY SERVICES AND/ OR CALLING MD
41 2021-01-09 tremor, feeling hot Within one minute of receiving the vaccine patient became very shaky and heated. Felt like she was g... Read more
Within one minute of receiving the vaccine patient became very shaky and heated. Felt like she was going to pass out. I gave the patient one 25mg Benadryl at 11:18 and orange juice. Within a few minutes of taking the Benadryl and also being able to take in air outside the mask her symptoms improved and felt herself.
41 2021-01-10 weakness, pain in extremity Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and bo... Read more
Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and body aches , tachycardia continued throughout 1/9/21, 1/10/21 tired weakness but no fever 1/11/21 all resolved except for slight left arm pain
41 2021-01-10 muscle twitching Facial twitching that began about 1-2 hours after injection. The facial twitching lasted about 24 ho... Read more
Facial twitching that began about 1-2 hours after injection. The facial twitching lasted about 24 hours.
41 2021-01-10 pain in extremity, burning sensation I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected a... Read more
I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected and everything else was fine, until 12/31/2020. My left upper thigh had a burning feeling around the outer part and in the goin on that thigh a painful lymph node. That afternoon I had a burning sensation on my left butt cheek. When I looked I noticed a very small rash with blisters. I waited through the weekend because I knew the OBGYN was not open. I called first thing Monday morning and made an appointment as soon as they could see me which was the next day (1/5/2021)at 3:30pm. The doctor took samples and sent them to the lab for testing. The test was positive for shingles. I am now taking valtrex for shingles.
41 2021-01-10 pain in extremity Arm Soreness, redness around injection site
41 2021-01-10 pain in extremity Jan 8, 2021 around 8pm, I felt cold and unwell but no fever. My left arm was sore. The following mor... Read more
Jan 8, 2021 around 8pm, I felt cold and unwell but no fever. My left arm was sore. The following morning, I had fever of 101.4F. I also had bad headache and muscle aches. I tool 500 mg of Tylenol, had lots of fluids and rest for 2 days. Sunday when I woke up I felt better and I feel well now.
41 2021-01-10 tingling Staff of facility experiences light headiness and extreme dizziness. Patient explained that her leg... Read more
Staff of facility experiences light headiness and extreme dizziness. Patient explained that her legs felt heavy and were very tingly. Monitored BP and remained within normal rages. Gave Benadryl at 11:35am. Patient also drank water and ate some food. After sitting for 45 minutes patient felt better
41 2021-01-11 weakness, tingling, pain in extremity, numbness, mild one side paralysis Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial nu... Read more
Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial numbness, extending to left shoulder / pectoris area. The symptom was mild throughout, did not get any worse. However, the symptoms have not subsided and I have continued to experience mild facial numbness (left). Yesterday, 01/07/21, I had an intermittent episode of tingling and left sided weakness which lasted a several hours in the afternoon. In addition to facial numbness, I also experienced left upper arm soreness, especially at site of injection. I also had a mild headache which lasted a three days.
41 2021-01-11 burning sensation a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin;... Read more
a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration at Left arm on 04Jan2021 09:30 at SINGLE DOSE for covid-19 immunization. Medical history included irritable bowel syndrome. Concomitant medication included amoxicillin, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), colecalciferol (VITAMIN D), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). No other vaccine in four weeks. The patient had allergies to ciprofloxacin(CIPRO). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.Since the patient got the vaccine, she had been experiencing a huge amount of gas and bloating as well acid and burning sensation in her throat and neck and chin on 04Jan2021 15:00. The outcome of the events was not recovered. No treatment received for the events. Information about Lot/Batch number is requested.
41 2021-01-11 feeling hot, tingling, pain in extremity Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; h... Read more
Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; heart was racing. Felt warm - no sweating but getting hot. At the site - the nurse called the EMT's - they Gave me 50 mg of benydryl syrup - in 20 min. checked heartrate first in 90's and then they rechecked and it was in 80's. Blood Pressure - 130/90. Half an hour later I was home - bad headache of two days. Left arm was very sore for those two days, not swollen, though. By third day those resolved.
41 2021-01-11 flushing, hot flush Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with rednes... Read more
Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .
41 2021-01-11 flushing, tingling FLUSHING, LIGHT HEADED, AND TINGLING
41 2021-01-11 flushing Patient reported to observation area for monitoring post-Injection.   No prior history of adverse ... Read more
Patient reported to observation area for monitoring post-Injection.   No prior history of adverse reactions or allergic reactions to any medications, vaccines or injections.   She reported to myself (Dr.) at 4:05 pm with feeling of lightheadedness, flushing and racing heart beat.   Initial Exam: Vitals: 143/87, HR 114, O2 sat 100% CV: Tachycardia, regular. No m/r/g Respiratory: CTAB. No w/r/r Skin: Facial flushing but otherwise no rash or hives. Oral: no tongue or lip swelling   Patient placed in supine position on stretcher, received water hard candy.   Repeat vitals @ 4:30: 151/84, HR 107, Sp O2 100% Exam: Unchanged.   After an additional 15 minutes of rest patient was able to ambulate without assistance and ultimately return to home via uber. Boyfriend was alerted.
41 2021-01-11 flushing Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her th... Read more
Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her throat is closing. Patient has some inspiratory stridor. She was moved to a room and given intramuscular epinephrine, diphenhydramine, famotidine, and methylprednisolone.
41 2021-01-11 hot flush Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot fla... Read more
Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; This is a spontaneous report from a contactable Nurse (patient). This 41-Year-old female Nurse (no pregnant) received first dose of BNT162B2 (Lot number: EJ1685) on 04Jan2021 09:00 AM on Left arm for COVID-19 immunization. Medical history was migraines. Concomitant drug was not reported. Known allergies: amoxicillin, cefaclor (CECLOR), ciprofloxacin hydrochloride (CIPRO), erythromycin, Zithromax. Patient experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days following injection on 05Jan2021 00:30 (reported as 04Jan2021 12:30 PM) with outcome was recovering. Treatment: Medication for nausea (zofran). Covid test post vaccination on 06Jan2021, result unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Follow-up attempt are not possible. No expected further information.
41 2021-01-11 numbness, speech disorder The left side of her face, it didn't go completely numb, but mostly; still can't chew on the side of... Read more
The left side of her face, it didn't go completely numb, but mostly; still can't chew on the side of the mouth; difficulty speaking; her eye socket, it didn't feel like her eye was there; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK923, expiration date: Apr2021), via unknown route of administration on 30Dec2020 at single dose (first dose by injection once to left upper arm, by the shoulder, a little down) for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medications were reported none. Her blood pressure was diagnosed years prior to the report, like 10+ years prior to the report, but she did not know if it had anything to do with it. The left side of her face, it didn't go completely numb on 30Dec2020, but mostly: stated her eye socket, it didn't feel like her eye was there, and her mouth, she had difficulty speaking, she still could not chew on the side of the mouth in Dec2020. Stated it felt like pulling, like something pulling, like a rope was tied and pulling backwards to the back of head and downward. States this lasted 2 days thankfully, and she did not regret getting it. She Provided weight as a lot of pounds, said she was joking. The vaccine was not prescribed by a doctor, her job offered it, she worked at a hospital, so it was voluntary and she took it. The event started maybe 6 hours after getting the vaccine, it was while she was sleeping, she woke up, she had slept, it was in the middle of the night, and was gone by Saturday for sure. This was her first dose. States site of administration was where she typically gets flu shots. The outcome of the event The left side of her face, it didn't go completely numb was recovered on 02Jan2021. The outcome of other events was unknown.
41 2021-01-11 pain in extremity 12/18/2020 Night in pain on right side of arm and she had a big ball under the arm pit the size of... Read more
12/18/2020 Night in pain on right side of arm and she had a big ball under the arm pit the size of a base ball and ER and your lynodes had swollen. Gave you IVProphen and Tylneol Took a week in a half for swollen to go down.
41 2021-01-11 tingling, numbness I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which ... Read more
I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little "tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little "tipsy". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
41 2021-01-11 tenderness worsening of the rash developed tender/swollen supraclavicular lymph nodes
41 2021-01-11 tremor Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue... Read more
Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm
41 2021-01-12 inability to speak, slurring Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progre... Read more
Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progressively worse over the course of the following day. I developed a persistent headache on Thursday that stuck around until Sunday. On Saturday morning I woke up feeling ok, still had the dull headache, but was ok enough to be up and around. At approximately 10:30 Saturday morning I was hit with stroke symptoms. I had weakness in my left hand, tunnel vision, couldn?t understand words that were spoke to me and was aphasic with garbled speech. Went to local ER and was worked up for stroke. Symptoms resolved Within approximately 45 minutes. All tests, lab results ok.
41 2021-01-12 weakness, pain in extremity Arm Sore, fatigue, weak, body aches, not feeling well
41 2021-01-12 feeling cold 103 Fever 24 hrs chills 48 hrs tired 48 hrs nausea 72 hrs sweating 72 hrs headache 72 hrs
41 2021-01-12 feeling cold 2 dose, feeling of being cold, not able to warm up, unable to sleep
41 2021-01-12 hot flush, burning sensation, feeling hot The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite ... Read more
The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite right and something may be wrong. She stated she was feeling all warm. She was complaining of mild heat or burning traveling from the vaccination arm, across her chest to the other arm and down her torso. Did not complain of any breathing difficulties or other symptoms. Her heart rate and respirations were normal. Upper extremities were examined for redness or hives - none found. The heat flash lasted about 2 minutes then she stated she felt normal. She was observed for another 20 minutes. She was examined again before leaving and no signs or symptoms were noted at that time. She felt normal before leaving the clinic.
41 2021-01-12 muscle spasms, migraine fever loss of appetite headache/migraine body aches muscle cramps, rash
41 2021-01-12 pain in extremity Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swellin... Read more
Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swelling with pain from forearm to shoulder. Woke on Saturday, 1/9/21 with enlarged/swollen lymph nodes under left arm, had headaches throughout the weekend. By Monday, 1/11/21 most symptoms had resolved with the exception of some arm soreness.
41 2021-01-12 pain in extremity positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have he... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain
41 2021-01-12 cold extremities, numbness So within a few minutes I had numbness and coldness in the entire arm and a headache. Then maybe 10 ... Read more
So within a few minutes I had numbness and coldness in the entire arm and a headache. Then maybe 10 hrs later, nausea, numbness, body aches, joint pain, headache and fatigue.
41 2021-01-13 weakness 10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days.... Read more
10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days. 3rd day post injection nausea continued and started experiencing back/flank pain. 4 and 5th day post injection still have nausea/back pain and chest pain, headache. Overall tiredness and weakness. I was also tested for Covid and it was negative.
41 2021-01-13 weakness Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours a... Read more
Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours after second dose.
41 2021-01-13 feeling hot, tingling, weakness within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over for... Read more
within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over forty minutes to include hypertension, nape of neck "fullness", weakness, and tingling hands. HR in '70's initially then progressed to tachycardia in 130's. EMS called for ED transport.
41 2021-01-13 feeling hot, tingling Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightn... Read more
Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightness in throat; symptoms lasted 0 days
41 2021-01-13 feeling hot, tingling Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL324... Read more
Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL3246. Pt states "I am very nervous about getting this". Pt brought a co-worker with her for support. Pt has "MS and Anxiety". Pt received her vaccine without any difficulty. While sitting for her observation time after the vaccine she began having some "tingling of her tongue and face feels hot". Pt denies any breathing difficulty. Pt states "I am not sure if this is from my anxiety or a reaction". Pt is drinking water with honey. Gave her some fresh water and monitored. Checked on her a couple minutes later. She was in the chair and then up to walk and was concerned "my legs are feeling tingly and a little cold". When asked if she ever takes BENADRYL for her previous medication reactions Pt states "yes". I asked her if she has someone who can drive her home and she made arrangements for her co-worker to take her. Gave Pt BENADRYL 25 mg po one for potential reaction symptoms at 15:05. Moved Pt to a quieter place to monitor and observe. Gave her a warm blanket and some juice. Vitals at 15:18: BP= 116/68, HR=80 Resp rate 16-18. Pt is alert, oriented and states "feeling a little better". Tingling sensation is "leaving". Pt denies any respiratory symptoms. Monitored by RN. Pt set up with telephone call with Employee Health Provider, PAC. Determined this is most likely symptoms caused by her anxiety. Pt left ambulatory with her co-worker and symptoms were resolved.
41 2021-01-13 feeling hot, slow speech I was approached by a person in the center at approx 1000 stating she had an employee that received... Read more
I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.
41 2021-01-13 mild one side paralysis, pain in extremity, facial paralysis Approximately 10 hours post injection, she started to feel left sided weakness/slight pain, headache... Read more
Approximately 10 hours post injection, she started to feel left sided weakness/slight pain, headache, dull neck pain that extended all the way down to my left foot and left arm soreness. She noticed facial droop on the left side at which case, she decided to sleep it off. When she woke up the following morning, She still had a slight droop but not as noticeable. Symptoms disappeared approximately 24 -30 hours post injection.
41 2021-01-13 hot flush, feeling hot 1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm... Read more
1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.
41 2021-01-13 tingling, hot flush, burning sensation Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips... Read more
Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.
41 2021-01-13 tingling, numbness Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and no... Read more
Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.
41 2021-01-13 tingling Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I... Read more
Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I was aching I had a fever 102.8 I had chills, body aches, my muscles where hurting, I also felt the pins & needles on my feet everything lasted about 36hrs. The headache lasted about 3 days.
41 2021-01-13 sensory loss, numbness Severe axillary, supraclavicular, and ant cervical lymph node swelling on left. Left hand and facia... Read more
Severe axillary, supraclavicular, and ant cervical lymph node swelling on left. Left hand and facial numbness. Stroke w/u in ER with CT angio and perfusion and brain MRI with w/o gad all normal, labs normal. Sensory deficit resolved in 24hrs. Lymphadenopathy still severe at present.
41 2021-01-14 hot flush hot flash and rapid heartrate
41 2021-01-14 numbness, cold extremities, tingling On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was... Read more
On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was numb and lock. Within minutes, I felt tingling sensations along all my fingers and thumbs. Then numbness at the tips. Then, both my hands were very cold. At about 2- 3, I fell groggy, tired. Then came the chill and fever, also light headaches. The numbness was gone. 1/13 I hit my right funny bone and my pinky, ring, and middle fingers were locked up tight. I tried to uncurl them. But they stayed locked. It lasted about 1-2 minutes. I got stomach pain around 5. 1/14 I have excessive phlegm at around 3pm and currently still have excessive phlegm. Then at around 10 pm, I had bad warped vertigo.
41 2021-01-14 numbness lethargy, body aches, dizziness, numbness in arms, dizziness, nausea, high pulse rate
41 2021-01-14 migraine 13-hour migraine; This is a spontaneous report from a contactable other healthcare professional (pat... Read more
13-hour migraine; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: El3246, via an unspecified route of administration on Left arm from 07Jan2021 10:00 to 07Jan2021 10:00 as SINGLE DOSE (first dose) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication includes prenatal vitamins. The patient previously took amoxicillin and experienced allergies. The patient is not pregnant. The patient experienced 13-hour migraine the day after the vaccine on 08Jan2021. The outcome of the event was recovered.
41 2021-01-14 pain in extremity Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At app... Read more
Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At approximately 0400 + chills, HA, body aches, and nausea without emesis. + fever (Tmax 100.3), Patient reports yesterday took motrin/tylenol around the clock. Today (1/15), Patient reports no fever today but ?brain fog? and feelings of fatigue. Patient reports last dose of motrin 600 mg at 08:00. Patient reports she called off work yesterday due to not feeling well. Last day of work and shift - ?Tuesday, January 12th Home remedies? - Tylenol, motrin, rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the TCH Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she called out of work yesterday, next scheduled shift Monday (1/18). Patient educated to manage her RTW according to the TCH Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.
41 2021-01-14 tingling, hot flush, feeling hot, flushing Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sic... Read more
Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.
41 2021-01-14 tremor, pain in extremity Day 1: Fever of 103, tremors, severe body and muscular pain. Shortness of breath. Unable to get out ... Read more
Day 1: Fever of 103, tremors, severe body and muscular pain. Shortness of breath. Unable to get out of bed for the entire day, severe headaches through the entire day Day 2: fever of 101, shortness of breath, severe headache, entire left arm in pain
41 2021-01-14 tremor Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, ext... Read more
Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, extremely high resting heart rate (over 100-usually under 60)
41 2021-01-15 facial pain, nerve pain I was exposed to Covid in November. I tested negative twice but had nerve pain along the right side ... Read more
I was exposed to Covid in November. I tested negative twice but had nerve pain along the right side of my face when my son had tested positive. Both times I got the vaccination the nerve pain in my face came back. It was fairly painful the second time. The concern is that I had an inflammatory response similar to when I actually may have had Covid both times. It went away within 48 hours and I have been done since.
41 2021-01-15 numbness Numbness to central part of my face one hour after vaccination. Went home and took 800 mg of ibuprof... Read more
Numbness to central part of my face one hour after vaccination. Went home and took 800 mg of ibuprofen and 25 mg of benedryl then went to bed (after working night shift). Upon waking around 4pm the numbness was gone
41 2021-01-16 difficulty speaking, numbness, tingling Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/n... Read more
Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.
41 2021-01-16 feeling cold AM after vaccine patient reported achiness, chills and palpitations starting 3-4 hours after vaccine... Read more
AM after vaccine patient reported achiness, chills and palpitations starting 3-4 hours after vaccine injection
41 2021-01-16 tremor severe shaking chills with onset at 10pm that lasted for 2 hours, no treatments used
41 2021-01-17 weakness, tingling, tremor Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a ... Read more
Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day
41 2021-01-17 weakness Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nod... Read more
Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nodes left upper extremity , head and neck. Began to feel difficulty swelling due to inflamed lymph nodes Treatment: Intravenous fluids, anti-inflammatory medication, sought treatment at an urgent care center. Ultrasound of left arm, axillary and neck and chest area for enlarged lymph nodes. Outcome- all symptoms resolved by 1/14 except some fatigue
41 2021-01-17 weakness I became very weak, lethargic, vomiting, sore...flu like symptoms. Sent home. Lasted for two to thre... Read more
I became very weak, lethargic, vomiting, sore...flu like symptoms. Sent home. Lasted for two to three days. I was told that if symptoms got worse to go to ER, but they started getting better with time.
41 2021-01-17 difficulty speaking Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went t... Read more
Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-01-17 feeling hot, pain in extremity 5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm p... Read more
5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm pain/ache- lasted less than 5 minutes. 30 minutes after vaccine rash, itching- lasted 2 days. 1 hour after vaccine- severe headache lasted 4 days. 4 hours after vaccine- ears/throat itching. Took Benadryl 50mg, Tylenol 1000mg, Albuterol Inhaler 2 puffs, and Famotidine 20 mg 4 hrs after vaccine.
41 2021-01-17 migraine I felt off/not myself for about 30 hours after the second dose. A migraine for 48 hrs. a red welt o... Read more
I felt off/not myself for about 30 hours after the second dose. A migraine for 48 hrs. a red welt on my arm at the injection site, I found it 1/13 it was small and got bigger overnight. I took Benadryl on 1/17 and it got smaller. the morning of 1/18 it was back just as big as before the benadryl. It is about 5 inches accross and 3 inches up and down
41 2021-01-17 muscle spasms COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had ch... Read more
COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had chest pain and sinus tachycardia. Received first COVID vaccine 12/18/20.Developed continuous vomiting 1.5 hours later then muscle aches and cramps as the day went on. Symptoms were gone later the next day except site soreness. Developed SOB and wheezing on 12/24/20. Went to ER - no treatment. Called her pulmonologist and increased diltiazem for the weekend. Called cardiologist 12/28/20 and was put on Corlanor. Took care of acute issues, but still had some SOB and palpitations.
41 2021-01-17 pain in extremity Sore arm, body aches, headache, cough, loss of smell
41 2021-01-17 pain in extremity headache, dry mouth, and arm pain
41 2021-01-17 pain in extremity Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain... Read more
Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain into cheekbone and facial swelling on left side of face. Sunday called my employee health who sent me to ER. Given steroids for 4 days for swelling and pain to left cheekbone and jaw area (especially at the joint) noted mild left side throat swelling on exam (internal)
41 2021-01-17 tremor tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloa... Read more
tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
41 2021-01-18 weakness, facial paralysis Patient reports left side facial drooping, weakness, headache. Patient states symptoms have resolve... Read more
Patient reports left side facial drooping, weakness, headache. Patient states symptoms have resolved. Patient referred to her PCP to discuss whether she should get her second dose.
41 2021-01-18 feeling hot, tingling Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed ... Read more
Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off to breath properly. ( I did not remove my mask) My heart then started to race and I felt a warming, tingling feeling throughout my body. I felt a little hot and light headed. I stayed sitting in my chair, tried to take some deep breath, and everything went away. This lasted about 30 to 60 seconds. I did NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone. I stayed for about 15-20 minutes post injection and then I left and drove home. I did feel tired and my arm is sore at injection site, but other than that, no other effects.
41 2021-01-18 flushing 22 hours after the second dose started to have an allergic reaction, hives all over back and chest a... Read more
22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.
41 2021-01-18 numbness palpitations, chest heaviness, numbness in fingers and toes, fatigue, nausea lasting 1+ week
41 2021-01-18 numbness 5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/... Read more
5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/o & talking w/friend. Over the course of 30 min cheeks feeling improved but felt that cheeks remained a bit numb. L eye puffiness gone. Left amb after 45 min HR 96, BP 112/70, pulse ox 99%.
41 2021-01-18 muscle spasms Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Sym... Read more
Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Symptoms gone by next day except residual site soreness. Asthma has worsened and is using Albuterol inhaler 1-2 times daily since second dose. Woke up 1/19/21 at 3am. Developed temperature then was diaphoretic. Vomited. Developed SOB, tachycardia, and wheezing.
41 2021-01-18 pain in extremity, feeling cold muscle aches; headache; soreness on left arm; felt cold in the evening of 08Jan2021; feels like havi... Read more
muscle aches; headache; soreness on left arm; felt cold in the evening of 08Jan2021; feels like having a fever/fever of 101.4F; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK9231, unknown expiration), via an unspecified route of administration in left arm, on 08Jan2021 at 09:15, at single dose, for COVID-19 immunization. Medical history included palpitations and COVID-19 on 26Mar2020 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). On 26Mar2020, the patient had nasal swab for COVID-19 which is positive. The patient has no known allergies to medications, food, or other products. Concomitant medications included ascorbic acid (VIT C), metoprolol, and unspecified multivitamins. The patient felt cold in the evening of 08Jan2021 at 20:00, feels like having a fever. The next morning (09Jan2021), the patient had a fever of 101.4F, muscle aches, headache and soreness on left arm. The patient took Tylenol, lots of fluids and bed rest. The patient started feeling better on 10Jan2021. COVID-19 vaccine was administered in a hospital. The patient is not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. On unspecified date, the patient was tested for COVID post vaccination (COVID-19 PCR) with unknown result. The patient did not receive other vaccine in four weeks. The patient recovered from the events in Jan2021.
41 2021-01-18 pain in extremity Body aches/fever/chills/headache/nausea. Arm soreness
41 2021-01-18 pain in extremity muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong tha... Read more
muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong that I can't have my foot firmly on the floor; Fever; strong headache; muscle pain generalized; tiredness; This is a spontaneous report from a contactable other Health Professional. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, Cardiac arrhythmia, allergy to crustaceans. The patient's concomitant medications were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergies, and the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 21Dec2020 09:30 AM at a single dose on left arm for COVID-19 immunization. The patient experienced fever, strong headache, muscle pain generalized, tiredness on 08Jan2021, and "muscle pain is so strong that I can't have my foot firmly on the floor" on 08Jan2021 07:00. No treatment was received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information about Lot/Batch has been requested.
41 2021-01-18 pain in extremity Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, f... Read more
Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed
41 2021-01-19 weakness, feeling hot, numbness, tingling The patient self-reported this adverse reaction through the hospital electronic reporting system. I... Read more
The patient self-reported this adverse reaction through the hospital electronic reporting system. In the patient's own words, "After receiving the COVID vaccine, I became very dizzy and weak. I felt like I was going to pass out more than once. Arms, legs, hands, and feet tingled, then went numb. Heart started racing, and I felt warm all over. My coworker told me I was very pale. I looked up reactions on the site and decided go to the ER and get checked. On the way over, I become slightly SOB. Once there my BP and HR was elevated, but after about an hour or so returned to normal. I still felt very weak and had some hand and leg tingling".
41 2021-01-19 feeling hot, flushing 5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observati... Read more
5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observation RN that she began feeling short of breath. RN administered Epinephrine in left thigh. Patient escorted to Emergency Department for further evaluation approximately 10 minutes later due to recurrence of symptoms.
41 2021-01-19 pain in extremity On Jan 12, the patient developed positional vertigo and nausea as well as sore arm. Vertigo resolve... Read more
On Jan 12, the patient developed positional vertigo and nausea as well as sore arm. Vertigo resolved when she fell asleep. Vertigo returned on Jan 16 and17. Diarrhea occurred 6 times on Jan 17. The patient noticed significant diffuse loss of hair from January 16 to 19. She continues to have some nausea.
41 2021-01-19 tingling NO PAST HX OF REACTIONS, AFTER IM ADMINISTERED PATIENTREPORTED TINGLING IN HAND COMPLETELY RESOLVED... Read more
NO PAST HX OF REACTIONS, AFTER IM ADMINISTERED PATIENTREPORTED TINGLING IN HAND COMPLETELY RESOLVED AFTER 15 MINUTES
41 2021-01-20 weakness, pain in extremity hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakne... Read more
hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms. She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm. Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-01-20 weakness I have had a severe headache since the day of vaccination, weakness, fatigue, dizziness, vomiting an... Read more
I have had a severe headache since the day of vaccination, weakness, fatigue, dizziness, vomiting and diarrhea.
41 2021-01-20 cold sweat, feeling hot, weakness, feeling cold Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feel... Read more
Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feeling like going to pass out
41 2021-01-20 feeling hot, flushing, tremor Flushing, tremor, feeling hot 10 minutes after administration. Given Benadryl 25mg orally and Lorata... Read more
Flushing, tremor, feeling hot 10 minutes after administration. Given Benadryl 25mg orally and Loratadine 10mg orally transferred to ED. Received Dexamethasone 10mg IV, Benadryl 12.5mg IV, Famotodine 20mg IV, and Normal Saline 1000mL bolus. Discharged home.
41 2021-01-20 migraine general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spo... Read more
general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spontaneous report from a contactable consumer (patient's sister). A 41-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on Jan2021 at the age of 41-year-old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had no covid prior vaccination. Patient previously received first dose BNT162B2 on Dec2020 at single dose for covid-19 immunisation. She had received her second dose of vaccine and it "hit her like a bus", she experienced general body pain, migraine, nausea, and a low grade fever of 99 on Jan2021. Outcome of events was unknown. Information on lot/batch number has been requested.
41 2021-01-20 numbness and pain in extremities Employee received first dose of Pfizer-BioNTech Covid-19 Vaccine on 12/28/20. Per Employee's manage... Read more
Employee received first dose of Pfizer-BioNTech Covid-19 Vaccine on 12/28/20. Per Employee's manager: Patient began experiencing symptoms of neuropathy and was admitted to the hospital as an inpatient on 1/18/21. Informed from neurologist that most likely Guillain-Barré syndrome resulted from vaccine and instructed to not receive 2nd dose of vaccine at this time.
41 2021-01-20 night sweats, hot flush, numbness On the 21st, I had acute fingertip numbness in the last three digits of the hand, bilateral facial n... Read more
On the 21st, I had acute fingertip numbness in the last three digits of the hand, bilateral facial numbness . I did go to the Hospital and everything was NEG. I started developing night sweats within a day or so. The hot flashes are between 2 and 4 am always.
41 2021-01-20 pain in extremity LUE pain; bone pain; mialgia/muscle aches; all over joint pain; fatigue; chills; sore Left deltoid; ... Read more
LUE pain; bone pain; mialgia/muscle aches; all over joint pain; fatigue; chills; sore Left deltoid; body aches/all over body aches; Headache; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK5730), intramuscular on 19Dec2020 07:00 am at single dose at left arm for covid-19 immunization. Medical history included hypertension, covid-19 (prior vaccination). No known allergies. Concomitant medications in two weeks included amlodipine besilate (NORVASC), ascorbic acid (VIT C), ergocalciferol (VIT D), magnesium chloride (MAG), zinc and daily multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. The patient experienced sore left deltoid, body aches, headache all on 19Dec2020 16:00, all over body aches, headache, fatigue and chills all on 20Dec2020, mialgia/muscle aches, fatigue, headache and all over joint pain all on 21Dec2020, headache, LUE pain, muscle and bone pain, fatigue all on 22Dec2020, patient finally felt better with decreased symptoms on 23Dec2020. Outcome of all events was recovered on unspecified date. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient received paracetamol (TYLENOL), motrin for events.
41 2021-01-20 pain in extremity Employee developed muscle aches and pains, fever, extreme fatigue, called off work 4 days. Continue... Read more
Employee developed muscle aches and pains, fever, extreme fatigue, called off work 4 days. Continues to have moderate-severe leg pain as of 1/20/21. Tylenol brings pain from moderate to mild.
41 2021-01-20 tingling, facial paralysis tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is ... Read more
tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected.
41 2021-01-21 feeling hot, tingling Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav... Read more
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
41 2021-01-21 numbness Numbness in Left hand
41 2021-01-21 muscle spasms Patient received Covid19 Pfizer dose 1 vaccination at 1pm. Advised to wait 15 minutes post injectio... Read more
Patient received Covid19 Pfizer dose 1 vaccination at 1pm. Advised to wait 15 minutes post injection. During waiting period experienced "vision blurring" and "pressure behind eye". Spoke with Dr, monitoring vaccine site. Advised to wait 15 more minutes before leaving. Left vaccination site and started driving home. (Around 1:40pm) Within a few minutes had "extremely sore neck, couldn't turn neck left or right without discomfort" , and felt "thickening of neck." Pain spread from neck to shoulders and mid back. Called Dr, advised to go to return if close or go to nearest ER. Was already miles away from original site so patient went to ER. Received Benadryl. Felt like "giant muscle spasm that wouldn't stop."
41 2021-01-21 pain in extremity Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer ... Read more
Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am. The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications. She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa. The employee informed employee health director on 1/20/2021 and evaluated on same day. On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.
41 2021-01-21 pain in extremity Immediate nausea and dizziness followed by increasing fatigue, brain fog and cognitive difficulties ... Read more
Immediate nausea and dizziness followed by increasing fatigue, brain fog and cognitive difficulties (I.e. driving and returning to work after) especially involving quick movements, tracking and concentrating. Moderate Arm soreness increased from the time of shot continuing beyond 24 hours and making it difficult to lift or move the arm
41 2021-01-22 pain in extremity For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-li... Read more
For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-lightheaded, tired, sleepy began after an hr or so after administration and continued throughout the day, blood pressure increased significantly after a few hrs (151/94); was much better the following day, only feeling tired and having pain at site of vaccine/upper arm. Dose 2: administered in the pm- lightheaded slightly for the first hr, more dizzy after 2.5 hrs, blood pressure ok, but severe headache; woke up with chills 2-3x that night, woke up with headache still, no fever, joints aching more than usual in spite of taking lots of ibuprofen; slight upper arm pain. Headaches have continued and my typical joint/back pains seem to be a lot worst and not really responding to ibuprofen. May be coincidence, maybe not. Thank you.
41 2021-01-22 throat numbness, numbness Numbness right side of throat, right side of tongue, right side of face and right side of neck. Sym... Read more
Numbness right side of throat, right side of tongue, right side of face and right side of neck. Symptoms still present at the time of release
41 2021-01-23 facial pain Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbe... Read more
Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.
41 2021-01-23 flushing, pain in extremity L arm pain and swelling at injection site. Upper body aches unable to sleep. Lasted about 12-15 hour... Read more
L arm pain and swelling at injection site. Upper body aches unable to sleep. Lasted about 12-15 hours was gone about 27 hours after injection. Fatigue and feeling flush then chilled very mild. No fever
41 2021-01-24 weakness, feeling cold I had chills, severe body aches, head ache, weakness, fever of 100.5. Symptoms lasted around 36 hour... Read more
I had chills, severe body aches, head ache, weakness, fever of 100.5. Symptoms lasted around 36 hours.
41 2021-01-24 weakness, numbness, pain in extremity Left arm numbness in thumb, wrist, and upper arm. Left arm weakness and achiness. Treated with ibup... Read more
Left arm numbness in thumb, wrist, and upper arm. Left arm weakness and achiness. Treated with ibuprofen; tylenol; ice to neck, shoulder and wrist; range of motion exercises; heat for muscle relaxation; rest. Decreased pain and ache with rest.
41 2021-01-24 weakness, migraine, tremor following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose... Read more
following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose on 1/19/2021- swelling and pain at injection side, right axilla severe pain, flu like symptoms, nausea, headache. migrane developed on day 3, on day 4 hives and pruritus all over the body, swelling of hands and feet, on day 5 the symptoms worsened despite medicating with OTC benadryl 50mg every 6hrs. Contacted PCP and was prescribed prednisone 20mg daily with some improvement. day 6- today rash still present, pruritus present, weakness, dizziness, shaky. unable to work or drive.
41 2021-01-24 weakness, migraine Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right,... Read more
Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right, flu like symptoms, headache, joint pain followed by migraine headache on day 3 post second dose. On Saturday day 4 hives, itching all over the body. Treated with oTC Benadryl 50mg q 6hrs. On day 5 the rash was more severe. Contacted PCP and was prescribed prednisone 20mg daily. Day 6- today, rash slightly improved but still present and itchy. Feeling weak and dizzy.
41 2021-01-24 pain in extremity, weakness body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizz... Read more
body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizziness. Pain to left arm
41 2021-01-24 tingling, numbness, burning sensation, pain in extremity On 1/15/21, I had numbness and tingling, pain and burning in extremities. Went to the ER, had MRI, ... Read more
On 1/15/21, I had numbness and tingling, pain and burning in extremities. Went to the ER, had MRI, had lumbar puncture, symptoms assessed, blood work and diagnosed with Guillian Barre.
41 2021-01-24 tingling At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency ki... Read more
At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency kit brought to scene. Client reports feeling pins and needles in the back of her head. She feels that her tongue and neck are swollen but as assessed, they were not swollen. She also reports feeling tingling in her tongue and neck. She was AAOx4, in no acute distress, no SOB noted. Skin and lip color normal, cap refill <3 seconds. Heart and lung sounds normal. Vitals: BP: 128/80, HR: 90, O2: 99% on RA, RR: 18. She did not report any pain. EMS was not called at this time. It was decided by RRT team that client can be monitored for an additional 30 minutes. RN stayed with client throughout 30-minute monitoring period. RN stated that during monitoring period, client was fine but kept reporting that she felt a lump in her throat. Husband talking with RN revealed that client is not diagnosed with anxiety but does have it. At the end of her 30-minute monitoring period at 1:40 pm, RRT was called again. RN already with client and client reported that she felt tingling everywhere again all over her body and felt like she could not breathe. Additionally, she had that feeling of being embarrassed with the sudden rush of heat throughout her body. Additional RN's arrived to scene at 1:41 pm. Upon assessment, she was not SOB but had rapid breathing associated with anxiousness and nervousness, which she reported. RN noticed client's hands and arms were shaking and client stated it was because she was nervous. Client speaking in full sentences. At this point, RRT RNs decided that client needs 911 assistance which was activated by Fire Chief on site. RNs also assessed that client's tongue was swollen again. Heart and lungs sounds were normal. Vitals at 1:49 pm: HR: 102, BP: 144/70, O2: 95%, RR: 21. At this point, on the basis of the symptoms she was experiencing, RN's decided to administer Benadryl 50 mg IM that was in the emergency kit. When the decision was made, client was asked if it was okay to administer Benadryl IM. She was explained the purpose of Benadryl, the side effects, and risks and benefits. Client consented to receiving Benadryl IM. Benadryl 50 mg IM administered to RA by RN at 13:51. By 13:53, her tongue was not swollen anymore. At 13:58, she was not SOB anymore, talking in full sentences, no acute distress, tingling stopped. By 13:59, the same symptoms of tingling throughout her body, feeling a sudden heat rush throughout her body started again. HR: 65, RR: 21, O2 95%. At 14:01, EMS arrives, truck number 341, vitals stable on their end. At 14:04, client decided to go to RUHS via ambulance. One of the paramedics stated that client's hands were "cold as ice". At 14:07, report was given to paramedics/ambulance and client was in the ambulance. Care assumed by ambulance/paramedics.
41 2021-01-25 weakness Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had di... Read more
Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had difficulty standing. This lingered for an additional 3 days, but not as severe. Muscle pain especially in hips and back, weakness, fatigue, headache and loss of appetite.
41 2021-01-25 feeling hot Itchy throat, sudden warmth, see spots, chest tightness.
41 2021-01-25 flushing, burning sensation Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially ... Read more
Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially associate with the injection, 30 mins post injection after obs period I felt dizziness. Chills within an hour, accompanied by sweating. Continued to work through it because otherwise felt okay. Dizziness subsided shortly after additional antihistamine and Pepcid. Approximatley around 7 pm my face start burning and itching, I had a diffuse red rash all over my face and my torso. I took 50 mg of Benadryl and rash resolved. It was not hives, almost appeared as flushing, Over the weekend I had fevers, chills but nothing that prevented me from my daily life. I however, have felt since my 2nd vaccine throat irritation, and itching, sweating. I am just continue my Zyrtec and regimen I took several years ago when I had this type of immune response. I didn't bother with MD, I left a message with nurse.
41 2021-01-25 flushing Flushing, generalized itching, conjunctival injection, nasal congestion, dry cough
41 2021-01-25 pain in extremity My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in m... Read more
My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in my heart rate. I went from the 50's in a dead sleep to the 80's between 7-8am. Otherwise I had general lethargy, fatigue, and arm soreness. I did not have a fever.
41 2021-01-26 weakness, pain in extremity I had one episode of syncope in the morning on 1/22/2021 after waking up in the morning, two days... Read more
I had one episode of syncope in the morning on 1/22/2021 after waking up in the morning, two days after the 2nd shot but within 48 hrs. Other than that, I just had a moderate left arm pain (starting on 1/21/2021). Also generalized low energy level (starting on 1/21/2021) and very mild muscle soreness especially with both legs (starting on 1/22/2021) .
41 2021-01-26 weakness Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous rep... Read more
Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142, expiration date not reported) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin, shellfish, seafood. The patient's concomitant medications were not reported. The patient experienced fever, chills, body pains, headache followed by diarrhea, nausea, vomiting and weakness on 07Jan2021 10:00 pm. Treatment was received for the events (unspecified). The events resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included Nasal Swab on 09Jan2021: Negative. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
41 2021-01-26 numbness severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left... Read more
severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization. Medical history reported as none. The patient has no allergies to medications, food, or other products. There were no concomitant medications. 48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness. She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious. Information on the lot/batch number has been requested.
41 2021-01-26 pain in extremity, cold extremities, muscle spasms, hot flush, flushing, weakness weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding... Read more
weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.
41 2021-01-26 tingling, numbness, pain in extremity "The morning after my COVID vaccine, I woke up with numbness, tingling, and pain in my R great toe. ... Read more
"The morning after my COVID vaccine, I woke up with numbness, tingling, and pain in my R great toe. The next 48 hours the symptoms got worse, and I had paresthesia in b/l upper and lower extremities, my trunk, and my face. My symptoms resolved for 2 weeks, but returned on Jan 10th. They started the same way with numbness and paresthesia in my R great toe and have progressed since them. I'm currently have frequent episodes of paresthesia all over my body and have developed numbness and pain in my hands. I saw my primary physician on Jan 15th regarding the symptoms."
41 2021-01-26 tenderness, tingling Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial a... Read more
Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial and tongue swelling. Followed by 1 week of swollen glands and tender jaw.
41 2021-01-26 tremor, involuntary muscle movements After the first dose I began to shake uncontrollably and I had uncontrolled muscle movements in my w... Read more
After the first dose I began to shake uncontrollably and I had uncontrolled muscle movements in my whole body. I had the chills and a headache as well as muscle aches and a sore throat. After the second dose I had the chills again, headache, fever, sore throat, severe fatigue, muscle aches, runny nose that lasted over 24 hours.
41 2021-01-27 weakness All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest p... Read more
All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest pain on inspiration Mild shortness of breath Weakness Loss of appitite
41 2021-01-27 weakness All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, sever... Read more
All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, severe back pain, muscle aches, chest pain on inspiration, weakness, mild nausea with loss of appitite.
41 2021-01-27 facial pain, involuntary muscle movements I noticed left ear, left face, and left TMJ pain ~ 48 hours post 2nd- Pfizer vaccine. I noticed he... Read more
I noticed left ear, left face, and left TMJ pain ~ 48 hours post 2nd- Pfizer vaccine. I noticed headaches and increasing ear/TMJ pain up until today (1/28). The TMJ and ear pain is less today, but it's still difficult to open my mouth. I have tried Tylenol and Ibuprofen to alleviate the discomfort, but the OTC meds to not help.
41 2021-01-27 feeling cold, hot flush Patient felt flushed then cold and throat felt cold. No SOB nor difficulty breathing. Within ~22 mi... Read more
Patient felt flushed then cold and throat felt cold. No SOB nor difficulty breathing. Within ~22 minutes patients symptoms resolved and patient felt back to normal, leaving the clinic without further issues
41 2021-01-27 flushing 40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s.... Read more
40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.
41 2021-01-27 flushing Chest pain (left side) when breathing, flushing, dizziness, and difficulty breathing. BP within norm... Read more
Chest pain (left side) when breathing, flushing, dizziness, and difficulty breathing. BP within normal limits. Patient stabilized and left for home.
41 2021-01-27 numbness Decreased sensation in the L side of the face; This is a spontaneous report from a contactable nurse... Read more
Decreased sensation in the L side of the face; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), intramuscular via the left arm on 30Dec2020 18:00 at a single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ciprofloxacin. It was reported that the patient experienced decreased sensation in the L side of the face that lasted 3 days initially and now comes and goes on 30Dec2020 21:00. No treatment was given for the event. The outcome of the event was not recovered.
41 2021-01-27 night sweats Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a... Read more
Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the right arm on 09Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included thyroid cancer. The patient had no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath with activity, night sweats, and right jaw pain on 11Jan2021. Right jaw pain resulted in physician office visit. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious.
41 2021-01-27 pain in extremity Pain in left arm, chills, headache, body ache, nausea
41 2021-01-27 pain in extremity Fever; Headache; body aches; Sore arm; This is a spontaneous report from a contactable healthcare pr... Read more
Fever; Headache; body aches; Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Jan2021, at 18:30 as single dose for COVID-19 immunization. Medical history included hyperthyroidism and known allergy to latex. Concomitant medication included St. John's wort (MANUFACTURER UNKNOWN), elderberry (SAMBUCUS NIGRA), cetirizine hydrochloride (ZYRTEC). The patient experienced fever, headache, body aches and sore arm on 15Jan2021, at 04:30. No Covid prior vaccination was noted; the patient has not been tested for COVID post vaccination. No treatment was given for the events. The outcome of events was recovered in Jan2021. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
41 2021-01-27 pain in extremity Severe arm pain in the arm injection was given. Pain radiated down arm, across upper blades into nec... Read more
Severe arm pain in the arm injection was given. Pain radiated down arm, across upper blades into neck. No fever at any point. But did have chills and sweats. Severe pain lasted about 6 hours
41 2021-01-27 tingling, numbness 15-20 minutes post vaccine administration, patient experienced numbness, tingling of cheeks and lips... Read more
15-20 minutes post vaccine administration, patient experienced numbness, tingling of cheeks and lips - "very subtle". Lasted one hour then subsided. No return to numbness or tingling as of 1/28/21.
41 2021-01-27 tingling, pain in extremity 5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. St... Read more
5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. Started in plantar aspect of both feet and traveled upwards to my hands, in a matter of hours. Extreme pain in lower back and extremities caused me to go to the ER. Following lumbar puncture and a series of diagnostic tests, I have started on IVIG for Acute Inflammatory Demyelinating Polyneuropathy. This is a subtype of Guillain Barre syndrome, believed to be precipitated by autoimmune response generated from the 2nd covid vaccine. I am now on day 4 of my hospitalization.
41 2021-01-28 discomfort, numbness, tingling About a day after getting the vaccine, I felt a strange sensation of moving up and across the left s... Read more
About a day after getting the vaccine, I felt a strange sensation of moving up and across the left side of my face. It stopped about half way across my face, with a tingle sensation . My face was then numb for the rest of the day. It only affected half of my face, the left side (I got the vaccine in left arm). The same sensation occurred with the second vaccine dose, but it happened earlier on the day of the vaccine about 5 hours after getting the shot. The same tingle and numbing sensation filled half of my face.
41 2021-01-28 feeling hot, flushing Around 10 minutes after receiving vaccine, pt. c/o feeling flushed, hot and light headed. Pt. asses... Read more
Around 10 minutes after receiving vaccine, pt. c/o feeling flushed, hot and light headed. Pt. assessed by staff. BP: 100/68, HR: 68, RR: 16, O2 sats: 97%. No other symptoms noted. Pt. declines to go to emergency room. Will follow up with PCP if needed.
41 2021-01-28 feeling hot "Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove h... Read more
"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.
41 2021-01-28 muscle twitching, muscle spasms 245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bow... Read more
245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bowel dysfunction Following day, flu like symptoms, chills, aches, etc Rash still has not gone away I have had abdominal cramping and significant pain. It has worsened to resemble the pain I had prior to my hysterectomy and endometriosis ablation/scar tissue removal.
41 2021-01-28 pain in extremity, muscle twitching, tingling 45 mins after the injection tingling of left leg, spread through body by end of day. Left leg, lef... Read more
45 mins after the injection tingling of left leg, spread through body by end of day. Left leg, left arm, face, neck and chest had tingling sensation. From time of vaccine 1/13 through current date, symptoms are twitching of nerves/muscle in the left leg, left arm and face, electrical nerve shocks on left leg and left arm, right hand, arm tingling. Sharp pain left leg and left arm. Treated with prednisone 7 day pack.
41 2021-01-28 pain in extremity Severe left arm pain unresolved; first dose of BNT162B2 in the left leg; This is a spontaneous repor... Read more
Severe left arm pain unresolved; first dose of BNT162B2 in the left leg; This is a spontaneous report from a contactable physician. A 41-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3246), via an unspecified route of administration in the left leg on 06Jan2021 11:15 at a single dose for covid-19 immunisation. Medical history included eczema. Concomitant medication included spironolactone. The patient previously received first dose of BNT162B2 in the left leg on 16Dec2020 12:00 for covid-19 immunisation. On 06Jan2021 11:15, the patient experienced severe left arm pain unresolved. The patient received NSAIDS as treatment for the event. The patient has not tested positive for covid post vaccination. The outcome of the event severe left arm pain was not recovered.
41 2021-01-28 tremor This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her ... Read more
This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her left arm, via an unspecified route of administration on 08Jan2021 11:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone, loratadine (CLARITIN) and fish oil. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (first dose). The patient experienced severe chills with body shaking for 6 hours, excruciating headache, fever, sore throat, nausea and excessively high resting heart rate (over 100- usually under 60); all on 08Jan2021 20:30. No treatment was received for the events. The outcome of the events was recovered on 09Jan2021 02:30.
41 2021-01-30 weakness Fever and chills, fatigue, body aches, headache, weakness, vomiting, pain at injection site and back... Read more
Fever and chills, fatigue, body aches, headache, weakness, vomiting, pain at injection site and back pain, joint pain, that started approximately 10 hours post injection and lasted for approximately 36 hours.
41 2021-01-31 numbness have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a ma... Read more
have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a major flare-up of my condition; low-grade fever (between 99-100); severe muscle & joint pain; severe muscle & joint pain; existing nerve impingement affecting the left (L) side of my body & both sides of my face; decreased concentration & executive functioning; GI upset; anticipated some inflammation response to the vaccine; feel sick; This is a spontaneous report from a contactable other-HCP (patient). A 41-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 30Dec2020 at 18:00 at single dose in right arm for covid-19 immunization. Medical history included Ehlers-Danlos syndrome hypermobility type, IgA deficiency, cervical radiculopathy, spondylosis of cervical region, chronic hypertension, fibromyalgia, androgenic alopecia, seasonal allergies, and known allergies: gold, nickel. The patient's concomitant medications were not reported. The patient previously took prednisone and experienced allergies. The patient reported that she anticipated some inflammation response to the vaccine from 04Jan2021. Briefly, she started to feel sick around 04Jan2021, by 10Jan2021 was experiencing a major flare-up of her condition requiring additional medication and time off from work. She had had a low-grade fever (between 99-100) from 04Jan2021 for 7 days, severe muscle and joint pain from 04Jan2021. She had existing nerve impingement affecting the left (L) side of her body and both sides of her face from 04Jan2021. Beginning 12Jan2021 she had limited use in her L hand, numbness down the L side of her body into her L foot. This was most likely due to significantly increased levels of inflammation as a result of the vaccine. She had also had GI upset, decreased concentration & executive functioning from 04Jan2021. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.
41 2021-01-31 muscle spasms, tingling, numbness, cold extremities Two hours post injection, developed numbness, tingling, extreme cold in hands and feet with fatigue.... Read more
Two hours post injection, developed numbness, tingling, extreme cold in hands and feet with fatigue. Slept for 3 hours, awoke feeling better. 14 hours post injection developed severe body aches, chills, fever, numbness in hands and feet, severe abdominal pain and cramping, and a rash on arms and abdomen.
41 2021-01-31 night sweats, muscle spasms Received 2nd dose in left deltoid at 4:30pm on 1/9/21. Woke up at 3:30am with night sweats and cra... Read more
Received 2nd dose in left deltoid at 4:30pm on 1/9/21. Woke up at 3:30am with night sweats and cramping. Discovered started menstruating on 1/10/21, 1 week early which was unusual for me. Prior period was during 1st shot, 21 days prior. Typical cycle is 26 days +/- 2 days and tracked on a phone app. Woke up w/ same symptoms this AM (2/1/21) and got period early again, 21 days.
41 2021-01-31 pain in extremity red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area appro... Read more
red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; Severe pain from neck to hand, shoulder blade to chest (right side); Severe pain from neck to hand; severe pain from neck to hand, shoulder blade to chest (right side); unable to lift arm above shoulder; second dose received on 12Jan2021; first dose received on 18Dec2020; Chills; fatigue; hive; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 12Jan2021 (14:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: unknown) intramuscular (right arm) on 18Dec2020 for Covid-19 immunization. Medical history included "known allergies". The patient's concomitant medications were unspecified (received in 2 weeks). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 (pending clarification), the patient experienced chills, fatigue, and hive. On 13Jan2021 (07:00), the patient experienced severe pain from neck to hand, shoulder blade to chest (right side) and unable to lift arm above shoulder, and hive. On 14Jan2021 (pending clarification), the patient experienced red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. Information on the Batch/Lot number has been requested.
41 2021-01-31 tingling 10 minutes post vaccination pt reported tingling in right arm that spread to the fingertips. V/S wer... Read more
10 minutes post vaccination pt reported tingling in right arm that spread to the fingertips. V/S were taken, HR 80, T97.9, SpO2 98%. BP monitored BP 137/93. Pt observed for additional 15 minutes. Electrolytes given for rehydration. Discharged at 1712. Pt reported feeling better.
41 2021-02-01 migraine I exp severe migraine headaches lasted 5 days.
41 2021-02-01 nerve pain Bad headache that triggered a neuralgia attack; Bad headache that triggered a neuralgia attack; This... Read more
Bad headache that triggered a neuralgia attack; Bad headache that triggered a neuralgia attack; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EL8982) via an unspecified route of administration on arm right on 15Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included occipital and trigeminal neuralgia, C5-C6 cervical cage, temporomandibular joint syndrome (TMJD), cerebrospinal graft. Known allergy: shellfish, walnuts, mustard, sweet potato. Concomitant medication included gabapentin, acetaminophen. The patient previously took penicillin B, phenergan and chloral hydrate (PHENERGAN), Codeine and linalool, all experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 16Jan2021 06:00, the patient woke up with a bad headache that triggered a neuralgia attack. It persisted for 24hrs. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered in Jan2021.
41 2021-02-01 tremor Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, pani... Read more
Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, panic attacks, or heart issues. She started saying her lips were feeling numb and kind of strange and her back hurting. 50mg of benadryl was given at 940am. Patient continued to decline. She complained of chills, chest pain, and n/v. She was visibly shaking. BP was 168/137 HR 99 and oxygen 96%. 911 was called at 9:45am. AMR arrived at 9:55am and took over. Patient was taken to ER.
41 2021-02-02 weakness Around 6pm on Monday night (the day of my injection) I was feeling nauseous, I couldn't eat dinner,... Read more
Around 6pm on Monday night (the day of my injection) I was feeling nauseous, I couldn't eat dinner, then around 8:30 i started vomiting this continued until around 1am (i vomited around 4 times). I also had chills and body aches through the night. Tuesday I felt exhausted and had horrible body aches. Around 3pm the body aches were mostly gone but i still had no energy for the rest of the day. Today, Wednesday, i'm a little achy and still lack energy but feel much better than yesterday.
41 2021-02-02 numbness Numbness and tingling in fingers and hands, shortness of breath, tightness in chest.
41 2021-02-02 migraine MIGRAINE, NAUSEA, VOMITING, LIGHTHEADED, DIZZY, SORENESS AT INJECTION SITE
41 2021-02-02 pain in extremity Got nauseous within minutes of vaccine. Waves of nausea over the next 6 hours. Headache, lethargic,... Read more
Got nauseous within minutes of vaccine. Waves of nausea over the next 6 hours. Headache, lethargic, achy, slight fever, very sore arm and shoulder/neck.
41 2021-02-02 cold extremities Around 7:00pm, approx. 7hrs after receiving my second vaccine my left arm (the arm I received my inj... Read more
Around 7:00pm, approx. 7hrs after receiving my second vaccine my left arm (the arm I received my injection in) was extremely sore. As the evening progressed so did my discomfort & pain. By the time I went to bed I wasn't able to raise my left arm above my waist. When I woke up @ 5am my joints were achy & I had a headache. Both of my feet were freezing. Throughout the day on Tuesday, 2/2/21 my arm around the injection site continued to hurt & was fevered. I kept a headache all day. Today, Wed. 2/3/21 my left arm remains extremely painful in my upper arm. My left arm is swollen, red & fevered. There is a large 4.5in x 4.5in red, swollen, fevered area around the injection site. This is extremely painful & uncomfortable. I am worried the injection may have been administered subcutaneously instead of intramuscularly & may not be as effective as it should be. I spoke with the coordinator of ocupation health (who performs the vaccinations at my workplace). She advised me to submit this form.
41 2021-02-03 numbness Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating his... Read more
Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating history of anaphylaxis to iodine. 30 minutes after vaccination, client reported she had numbness of her tongue (anterior 1/3), some numbness of her lower cheeks/jaw. No difficulty breathing. BP120/85; HR 80. After a few minutes was reassessed and vitals were unchanged. Client felt anxious. No rashes, no breathing issues but continued anxiety and symptoms of numbness continued. 911 called. EMS assessed and vitals unchanged. Numbness lessened to just tip of tongue. Normal speech. EMS did not transport and father arrived to pick her up at 12:15 pm.
41 2021-02-03 migraine Both times I received the vaccine on the third day I my migraine was triggered and I experienced se... Read more
Both times I received the vaccine on the third day I my migraine was triggered and I experienced severe migraines, nausea and vomiting with extreme pain and sensitivity to light and sound. I also experienced severe body pain after both shots. I did not see my physician who I listed but she has notes about my history or migraines. It was suggested on the CDC tracking app to report here too since my reactions were severe.
41 2021-02-03 pain in extremity Fever; body aches; headache; fatigue; arm soreness; This is a spontaneous report from a contactable ... Read more
Fever; body aches; headache; fatigue; arm soreness; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration in the left arm on 20Jan2021 at 06:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (at the age of 41-years-old; Lot Number: EJ1685) on 30Dec2020 at 06:00 in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination except the first dose of the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 20Jan2021 at 19:00, the patient experienced fever, body aches, headache, fatigue, and arm soreness. The patient was not treated for the events. The clinical outcomes of fever, body aches, headache, fatigue, and arm soreness, were not recovered.
41 2021-02-03 pain in extremity Soreness in arm at injection, 24 hrs; Day after debilitating lower back pain; Day after debilitating... Read more
Soreness in arm at injection, 24 hrs; Day after debilitating lower back pain; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration on 18Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included psoriasis, hypothyroidism and insomnia. Patient has no known allergies. No COVID prior vaccination. Concomitant medications (Other medications in two weeks) included levothyroxine, trazodone (reported as "Trazadone"), phentermine and ergocalciferol (VIT D). No other vaccines in four weeks. Facility type vaccine was Workplace clinic. The patient experienced "soreness in arm at injection, 24 hrs. Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day. Pain in walking, sitting & movement", all on 19Jan2021 11:00 AM which resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for the events, also reported a s "Call into pcp but was not helpful". Outcome of the events was not recovered. Patient was not tested for COVID since the vaccination.
41 2021-02-03 tingling, weakness, pain in extremity, numbness currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous repo... Read more
currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-02-03 restless legs syndrome fever (highest 100.8), severe muscle pain, joint pain, jaundice (I have Gilbert's sydrome), axillary... Read more
fever (highest 100.8), severe muscle pain, joint pain, jaundice (I have Gilbert's sydrome), axillary and cervical lymphadenopathy on L side, headache, restless leg, nightmares
41 2021-02-03 seizure Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of a... Read more
Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of appetite. She reported that she went to a store, and apparently "passed out." Employees of the store told her that she had a seizure. Pt. was transported to local ER, where she states that she had a CT of brain, blood work and was told "everything is normal." Stated that she had COVID testing both in the ER and at work, both reportedly negative. This clinic, has thus far been unable to obtain the individuals medical records from the ER. When seen in our clinic on 2/3/21, pt. stated that she is feeling better, but fatigued. No other loss of consciousness reported by pt.
41 2021-02-04 discomfort Systemic: Other- tachycardia, elevated bp, radiating sensation, panic-Severe
41 2021-02-04 pain in extremity sore arm within 4hrs; fatigue; joint pain; fever; This is a spontaneous report from a contactable he... Read more
sore arm within 4hrs; fatigue; joint pain; fever; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3302) at left arm 08:30AM on 20Jan2021 for Covid-19 immunization. The patient had first shot 08:00AM on 30Dec2020 at right arm and experienced sore arm within 12hrs, fatigue, joint pain, skin itch, and enlarged right supraclavicular lymph node. The patient had no known allergies and other medical history was not reported. Concomitant medications included metformin. The patient experienced sore arm within 4hrs, fatigue, joint pain, fever around 12:15PM on 20Jan2021. No treatment received for the events. The patient had no Covid prior vaccination and not Covid tested post vaccination. The event did not resolve at the time of reporting.
41 2021-02-04 pain in extremity Soreness of arm ,The following day I woke up and felt fine and cup of coffer I felt nauseated , head... Read more
Soreness of arm ,The following day I woke up and felt fine and cup of coffer I felt nauseated , headache, Took Advil and headache was worse.. The following day I still had a really bad headache and felt nauseated .
41 2021-02-04 tingling I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was a... Read more
I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was about to pass out. I felt more comfortable staying at work where I could get immediate help. I had an extreme case of brain fog. That lasted about 3 hours. I started to have the feeling that you get when your limb is asleep. On day 4, I started to exhibit the symptoms again. I felt like I do when I have thyroid issues, so I went to see my endocrinologist, but he didn't do anything. I did have labs done. I started having blood pressure increases as well. I haven't been able to work out like usual since the vaccine and my sleep has been very poor. I wake up in the middle of the night and am unable to go back to sleep. I am now on heart medication, which is what I was taking previously for thyroid flare ups. I go back to see my endocrinologist in March.
41 2021-02-05 feeling hot 0945 pulled into medical site @ clinic . States she received vaccine @ 9:25 an waited 15 minutes a... Read more
0945 pulled into medical site @ clinic . States she received vaccine @ 9:25 an waited 15 minutes after receiving the vaccine & was cleared to leave. After she left the site she started feeling hot, c/o itchy rash on left side of neck, and feeling hot and shaky. EMS on site to evaluate patient. 9:47 gave Benadryl 25 mgm PO 10:10 symptoms resolved. Doctor notified. Patient instructed to take Benadryl 25 mgm when she gets home and to notify her PCP regarding additional f/u. Patient left site @ 1020.
41 2021-02-05 numbness Received 2nd dose vaccine. Experienced numbness in arm.
41 2021-02-05 pain in extremity, nerve pain After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, b... Read more
After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, body chills, lethargy, vomiting, head ache and arm pain. Took 50 hours to get out of bed and feel half normal. Thought I was on the road to recovery when the arm pain started to increase. No rash or swelling occurred at the sight. It presents with pain more nerve like pain in my shoulder, elbow and radiated to fingers. On Feb 5th the pain was so bad I went to see a shoulder specialist and are trying to figure out what is going on. My right arm remains painful to move with nerve issues. The specialist advise I report. In the meantime, I will follow up Monday with another specialist and also undergo some nerve testing.
41 2021-02-06 impaired body coordination, tremor Within ten mins, had a flare of pots and vestibular issues i e. Tachycardia, dizziness, ataxia, head... Read more
Within ten mins, had a flare of pots and vestibular issues i e. Tachycardia, dizziness, ataxia, headache, tremors in neck overall difficulty with balance. Have had similar symptoms with antibiotic use.
41 2021-02-06 pain in extremity Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morn... Read more
Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morning. 2nd dose, felt foggy, L arm pain & bad headache hours after. Fatigue the same night, had chills, couldn?t sleep and woke up with a temp of 100.3, sinus & ear pressure/pain, congestion & then a runny nose, headache, L arm & neck pain, felt like I was swallowing rocks, sore throat, diarrhea
41 2021-02-07 pain in extremity Headaches; Rigors; Extreme fatigue; left arm pain radiating up to neck and skull; left arm pain radi... Read more
Headaches; Rigors; Extreme fatigue; left arm pain radiating up to neck and skull; left arm pain radiating up to neck and skull; chest and back pain /stabbing pain in my left chest; chest and back pain; Nausea; heart palpitations; feeling of impending doom; This is a spontaneous report from a non-contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 18Jan2021 07:30 (at the age of 41-years) to as a single dose for Covid-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical vaccine data included that the patient received the first dose of BNT162B2 on 28Dec2020 at 07:15 (at the age of 41-years) in the left arm for Covid-19 immunization. There were no concomitant medications. On 18Jan2021 22:30, 15 hours after second injection the patient experienced symptoms which would best be described as a cardiac event. The patient elaborated that she woke from sleep with left arm pain radiating up to neck and skull, chest and back pain, nausea and stabbing pain in my left chest. This was associated with heart palpitations and a feeling of impending doom. The episode lasted 15 minutes and happened 4 times throughout the night. On 19Jan2021 at 07:30, 24 hours after injections the patient experienced headaches and rigors began with extreme fatigue. Unable to function type of fatigue. Fatigue persisted for 48 hours post injection. The patient was now 72 hours post injection and continued with headache and nausea. The patient did not receive any treatment for the events. The patient had not been tested post vaccination. The clinical outcome of event extreme fatigue, chest and back pain, heart palpitations feeling of impending doom, left arm pain radiating up to neck and skull and rigors was recovering. The outcome of events headaches and nausea was not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.
41 2021-02-08 numbness, weakness, tingling 5 minutes after vaccine injection reported bilateral arm tingling. Then proceeded to only left arm a... Read more
5 minutes after vaccine injection reported bilateral arm tingling. Then proceeded to only left arm and leg numbness and tingling. Subsequently, left facial numbness with left side body weakness and numbness.
41 2021-02-08 numbness Patient reported to the ED about an hour after receiving the first dose of COVID-19 vaccine (Pfizer ... Read more
Patient reported to the ED about an hour after receiving the first dose of COVID-19 vaccine (Pfizer brand). She complained of left sided facial numbness with no facial droop or slurred speech present at the time. Her vitals were taken, she was monitored and seen by a PA. She was given an education handout on allergic reactions to medications and scheduled to follow up with her primary care physician regarding her elevated blood pressure (182/100). Patient did not report prior history of hypertension. She was discharged and able to ambulate our of the ED and drive home. Coure of care approximately 1 hour.
41 2021-02-08 migraine, weakness I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness a... Read more
I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.
41 2021-02-09 weakness heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable fe... Read more
heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable feeling; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient) reported a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via unspecified route on right deltoid single dose for COVID-19 immunization on 03Jan2021, at 41-year-old. No medical history. Concomitant medication was reported but unspecified. After the patient had received the shot (Jan2021), her heart started beating fast, felt lumps grow up on her arm and became little short of breath. That went away rather quickly, about within 3 hours and the patient was still kind of weak and just uncomfortable feeling. Action taken for BNT162B2 was not applicable. Outcome of the events heart started beating fast, lumps grow up on her arm, short of breath was resolved in Jan2021; outcome of the other events was unknown. Causality assessment per the reporter was checked as yes.
41 2021-02-09 weakness Fatigue; dizziness; weakness; increased heart rate; This is a spontaneous report from a contactable ... Read more
Fatigue; dizziness; weakness; increased heart rate; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 20Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home/Senior Living Facility. Patient age at vaccination was 41 Years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia, Hashimoto's Thyroditis, allergy to Penicillin. Concomitant medications included ibuprofen (IBUPROF), loratadine (CLARITIN), sambucus nigra extract (SAMBUCOL), fluticasone propionate (FLONASE), and multivitamin. On 21Jan2021 the patient experienced fatigue, dizziness, weakness, increased heart rate, all reported as non serious. No treatment was received for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
41 2021-02-09 weakness Fevers greater than 101 even with Tylenol around the clock; heaviness in my head; chills; weakness a... Read more
Fevers greater than 101 even with Tylenol around the clock; heaviness in my head; chills; weakness and really tired; congestion (nasal - these symptoms continued for three days. Urgent care - Day two post vaccination.
41 2021-02-09 bell's palsy, facial paralysis, face paralysis This 41 yo female received her first Pfizer COVID vaccine (Lot EL1284) on 1/7/2021. She reports be... Read more
This 41 yo female received her first Pfizer COVID vaccine (Lot EL1284) on 1/7/2021. She reports being in good health, had no illness exposures (does work in hospital with children), and had no recent travel. She reports following her Covid vaccination, she had a sore arm at vaccine site for 4-5 days with no other issues. On 1/31 (day24) while putting on lipstick to take a selfie to send to her friend she noticed the right side of her lower face (lip area) felt "weird"- tingled and the corner of her mouth would not smile symmetrically with left. Her friend commented something was off with this picture. The next day this droop worsened with loss of facial lines/wrinkles on right (nasolabial fold), had tingling/numbness to lips and corner of mouth and inability to smile on right. This prompted her husband to bring her to the ER on 2/1/2021. She denied any fever, headache, weakness to arms/legs, no SOB/CP, dysphagia or speech issues or trauma. ER providers exam noted normal CN evaluation but documented mild right sided decrease in nasolabial fold vs left and loss of taste to anterior right tongue. She had no involvement of eye or forehead. She was diagnosed with early Bell's Palsy and treated with oral steroids and anti-virals. AS of 2/10/2021 with use of medications, she advised her facial weakness/droop had resolved but still has tingling. Her smile is symmetrical at this time. No c/o on loss of taste. Has diagnosis of Bell's Palsy. IHD case 9967.
41 2021-02-09 cold sweat, feeling hot At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front ... Read more
At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front 4 teeth were in so much pain I cried. I took 100mg of Tylenol and the pain lessened in about 2 hours. At approximately 10am on 2/5/21, I became clammy with shivers yet I was feeling over heated. My temperature was 99.3 degrees. I did not take any medicine but instead took a nap. When I woke up, my temperature felt normal. I did feel dizzy until around 4:3pm that same day. I still get headaches in the front of my forehead since 2/5/21.
41 2021-02-09 discomfort, tingling Around 11 hours after 2nd shot I woke up with chills, full body tingling, nausea, and couldn't get c... Read more
Around 11 hours after 2nd shot I woke up with chills, full body tingling, nausea, and couldn't get comfortable. About 5.5 hours later I had spiked a fever (101.1 temporal) and bad headache. The fever and headache continued all day. Around 7pm on 2/3 I took 1 extra strength Tylenol. The fever broke by Thursday morning and I was feeling better though I still had a headache. I did take 1 extra strength Tylenol around the clock Thurs into Friday. The headache continued to improve Thursday and finally went away by Saturday evening.
41 2021-02-09 difficulty speaking Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen... Read more
Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen circular hive/welt underneath injection site on left arm; pink and hot swollen circular hive/welt underneath injection site on left arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at 07:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included seasonal allergies from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, on 31Dec2020 in the left arm. On 21Jan2021 at 09:30, the patient experienced light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm. The patient did not receive treatment for the events. The clinical outcome of light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-02-09 numbness, tingling Tingling/numbness in both arms and hands; Tingling/numbness in both arms and hands; stiff joints in ... Read more
Tingling/numbness in both arms and hands; Tingling/numbness in both arms and hands; stiff joints in hands and feel like circulation is restricted; This is a spontaneous report from a non-contactable Other HCP (patient). This 41-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on the left arm, on 22Jan2021 (at 12:00 PM) at single dose for COVID-19 immunisation, administered at Clinic. No other vaccine was received in four weeks. Relevant medical history included hypothyroidism. Relevant concomitant medications included levothyroxine sodium (SYNTHROID), ibuprofen, colecalciferol (VITAMIN D), curcuma longa root (TURMERIC CURCUMIN) and sertraline hydrochloride (ZOLOFT). On 25Jan2021, the patient developed tingling/ numbness in both arms and hands; stiff joints in hands and feel like circulation is restricted. The patient was not treated for the events. The patient had not recovered from the events. No follow up attempts are possible. No further information is expected. Information about Lot/Batch number cannot be obtained.
41 2021-02-09 pain in extremity Felt a slight flu-ish the following day. 4 days after, I had Aches, headache, severe sneezing, cong... Read more
Felt a slight flu-ish the following day. 4 days after, I had Aches, headache, severe sneezing, congestion that was painful coughing and difficulty breathing. Right Leg aches.
41 2021-02-09 pain in extremity Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This ... Read more
Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 22Jan2021,16:30 at SINGLE DOSE (first dose, left arm) for COVID-19 immunization. Medical history included allergies: Latex from an unspecified date. Patient did not have COVID-19 prior vaccination. Patient is not pregnant. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced head and nasal congestion, ear ache, body aches, fatigue and, sore arm all on 23Jan2021 01:00. No treatment was given. Patient was not tested for COVID-19 post vaccination. Outcome of the events was recovering.
41 2021-02-09 pain in extremity The today (day 3) my lymph nodes, under arms, are swollen.; The next day (day 2) I experienced chill... Read more
The today (day 3) my lymph nodes, under arms, are swollen.; The next day (day 2) I experienced chills and body aches throughout the day; The next day (day 2) I experienced chills and body aches throughout the day; became suddenly tired in the afternoon; first dose was on 22Dec2020 while second dose on 22Jan2021; sore arm within a few hours of getting the shot; This is a spontaneous report from a non-contactable healthcare professional (patient). A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EL 3249; expiration date: unknown), intramuscular left arm on 22Jan2021 15:30 at a single dose for covid-19 immunization. Medical history included allergy to mango and passion fruit and covid prior vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EH 9899) at the age of 41-year-old intramuscular right arm on 22Dec2020 15:30 at a single dose for covid-19 immunization. The patient reported that on her second dose, she had sore arm within a few hours (22Jan2021) of getting the shot. The next day (day 2 [23Jan2021 11:45 AM]), she experienced chills and body aches throughout the day and became suddenly tired in the afternoon. The today [25Jan2021] (also reported as day 3 [24Jan2021]) her lymph nodes under her arms are swollen. As of now (Jan2021), she has no chills, body aches are not as bad, and her left arm isn't as sore, but her lymph nodes are still swollen. It was reported that the treatment was unknown. The patient has not been covid tested post vaccination. The outcome of the event shills was recovered in Jan2021, for the event swollen lymph nodes was not recovered, as for the events pain in arm and ache were recovering, while the outcome of the other events was unknown.
41 2021-02-09 tingling, numbness Patient describes "numbness and tingling feeling to left cheek off and on. feels like my face was in... Read more
Patient describes "numbness and tingling feeling to left cheek off and on. feels like my face was injected with lidocaine".
41 2021-02-09 tingling, nerve pain, burning sensation Horrible muscle and nerve pain in lower extremities. Burning sensation with shooting pain, numbnes... Read more
Horrible muscle and nerve pain in lower extremities. Burning sensation with shooting pain, numbness, and tingling in lower extremities. Feet contract and I am unable to walk on them if I do not keep them flat.
41 2021-02-09 cold extremities States shot felt weird going in to arm. Felt "thick". Ears began to ring and felt light headed 162... Read more
States shot felt weird going in to arm. Felt "thick". Ears began to ring and felt light headed 1625 BP 104/? O2 sat unable to obtain due to cold periphery 1630 BP 118/? O2 sat 97% cold periphery 1640 BP 137/86 HR 76 O2 sat 98% RR 16 lungs clear 1645 BP 127/75 HR 70 O2 sat 100% RR 16 1650 BP 130/79 HR 70 O2 sat 100% RR 18 lungs clear After 40 minutes stated felt better provided snack bar, apple and water was able to leave area at a baseline level.
41 2021-02-10 migraine got vaccine at 8:00 am around 1:00 pm started with a bad headache triggered a really bad migraine ca... Read more
got vaccine at 8:00 am around 1:00 pm started with a bad headache triggered a really bad migraine caused nausea and vomiting, then started with body aches, fatigue , it's been 5 days now still have migraine.
41 2021-02-10 pain in extremity Injection site was painful (more than with my typical flu shot) after 2nd COVID injfection on 2/4 (T... Read more
Injection site was painful (more than with my typical flu shot) after 2nd COVID injfection on 2/4 (Thursday). The arm continued to be sore. On Saturday 2/6 after removing Bandaid I noticed a large red/warm area that was painful to the touch but not indurated. I outlined the area. Took NSAID and antihistamine PO daily, ice PRN. Today 2/9 the redness continues to increased in size. It is sore, red and feels itchy. Today the area measures 6 inches x 4 inches. I have communicated with my PCP via medical message. If the area continues to increase in size I will make an appointmen in the next 1-2 days due to concerns about developing cellulitis.
41 2021-02-10 pain in extremity Fatigue; Arm pain; Headaches; This is a spontaneous report from a contactable consumer (patient). A ... Read more
Fatigue; Arm pain; Headaches; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 16:45 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. There was no other vaccine received within four weeks prior to vaccination. The patient experienced fatigue, arm pain, headaches Jan2021. Outcome of the events was unknown and no treatment was given. Events were considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information on the lot/batch number has been requested.
41 2021-02-10 seizure Patient started having seizures after 15 minutes of receiving the vaccine. The EMS was called. The... Read more
Patient started having seizures after 15 minutes of receiving the vaccine. The EMS was called. The pt was place on oxygen due to O2 dropping. The EMS took the pt to hospital
41 2021-02-11 hot flush Pt received vaccine at 3:14pm. She started having a reaction at 3:27pm and flagged the nurse down. ... Read more
Pt received vaccine at 3:14pm. She started having a reaction at 3:27pm and flagged the nurse down. She stated she was having a tachy cardia episode and hot flashes. We gave her some water and she took off her beanie and the provider on site was asked to come over. Provider came in and started asked her reaction question. Pt denied any itching, SOB, chest pain/tightness and throat swelling/closing. Pt did indicate her heart rate jumped on her fit bit, doctor asked for a set of vitals 180/100, 130 pulse and 97%. At this point we took patient back into exam room. The patient was given Epi and Benadryl 3:34p 911 called Vitals checked: 3:37 168/88, 132, 98% Pt was monitored until ambulance showed up. Pt was transferred to MCR
41 2021-02-12 flushing, tingling 7 minutes after vaccine, I felt my heart pounding heavily and checked my iwatch. It indicated that m... Read more
7 minutes after vaccine, I felt my heart pounding heavily and checked my iwatch. It indicated that my Heart rate went from 88 to 141 in the past 5 minutes while sitting. I then felt flushing throughout my body. I had the sensation of tingling on my face and lips and told the present employees that I felt weird. They retrieved the doc, who then took my pulse ox - registered at 96/97. Then they took my blood pressure and it was 180/100 (I typically have low blood pressure 98/60). I started to feel disequalibrium and nauseous and the doc to be back to a room. She administered a dose of IM EPI and IM benedryl and called EMS. My symptoms persisted and the doc told the EMS workers I had urticaria on my face during her case presentation. I was transported to the ED, where I was monitored. My symtoms had reduced following epi and benedryl but returned when I was in the ED. The doctor administered pepcid and solu-medrol and zofran. They also conducted and EKG- reportedly normal. These medications helped control my symptoms and my BP had returned to normal (120/70) following meds. discharged on a tapering dose of steriod and zofran prn.
41 2021-02-12 numbness, bell's palsy, facial paralysis Information reported by individual involved as follows. AFTER 2ND VACCINE OF PFIZER I HAD SEVERE MU... Read more
Information reported by individual involved as follows. AFTER 2ND VACCINE OF PFIZER I HAD SEVERE MUSCLE ACHES AND FEVER ABOUT 12 HOURS POST VACCINE WHICH IS EXPECTED DIAGNOSED MILD CASE OF BELLS PALSY. LEFT SIDED FACIAL NUMBNESS TO CHEEK, TONGUE, MOUTH GUMS, INCREASED SNORING, THESE SYMPTOMS WERE NOTED SHORTLY AFTER VACCINE #2. I DID NOT PUT IT TOGETHER AT THE TIME THAT I WAS HAVING REACTION TO THE VACCINE ONLY AFTER DOING SOME RESEARCH ON WHAT COULD BE LEADING TO LEFT SIDED TONGUE NUMBNESS DID I REALIZE I COULD BE HAVING BELLS PALSY A REACTION TO THE VACCINE. WENT TO EMPLOYEE HEALTH ON 2/1/21 AND THEY NOTED POSTIVE MILD CASE OF BELLS PALSY. AFFECTED IS LEFT SIDE OF FACE, GUMS CHEEK TONGUE AND SLIGHT DROOP
41 2021-02-13 weakness Within 45 minutes experienced throat tightness, shortness of breathe. Less than 4 hours later, expe... Read more
Within 45 minutes experienced throat tightness, shortness of breathe. Less than 4 hours later, experienced diarrhea and abdominal pain. Less than two months later, my right shoulder dislocated and am now having issues with range of motion, pain and weakness.
41 2021-02-14 breast pain chills, fever, sweating., body aches - muscle and join pain, sore throat, mild headache, tiredness, ... Read more
chills, fever, sweating., body aches - muscle and join pain, sore throat, mild headache, tiredness, R arm (injection site) pain including shoulder, shoulder blade and right breast Lasted about 12 hours and resolved without sequaele. No treatment given or medication taken.
41 2021-02-15 migraine c/o headache and nausea within 5 minutes of getting the vaccination. Has a history of migraines but ... Read more
c/o headache and nausea within 5 minutes of getting the vaccination. Has a history of migraines but migraine was sudden onset. Pt monitored in my office states she had history of migraines and uses Imitrex. She refused to go to ER and injected her imitrex and was monitored for an hour . Again refused to go to Er called her mother in law to take her home. 1700 called her states still had minor migraine but somewhat better at this time.
41 2021-02-15 pain in extremity Pain in Arm; Pain and swelling below right arm pit; Headache; Nausea
41 2021-02-16 tension headache, burning sensation, flushing Tightness in the chest, throat, ears, and head with a feeling of dizziness started on the 4th day af... Read more
Tightness in the chest, throat, ears, and head with a feeling of dizziness started on the 4th day after receiving the vaccine. Feeling extremely fatigued and difficulty breathing. Falling asleep whenever and wherever. Rashes all over the body including the face that come and go. Burning pain and a feeling of flushing when the rash develops. Waking up in the nights with the rashes and itchiness that is unbearable. Experiencing difficulties staying focused and complete a single task. Off from work for a week now due to continuous dizziness.
41 2021-02-17 burning sensation After receiving the shot, I had an initial burning sensation that went away within 30-45 seconds. Af... Read more
After receiving the shot, I had an initial burning sensation that went away within 30-45 seconds. After about 1.5 to 2 hours after the shot, I noticed a small, hard bump at the injection site. By the next morning (2/17), the bump was larger and warm to the touch, and painful, but tolerable. By mid morning, I had aches in my upper back/neck. By noon, all of my joints were aching and I had muscle pain all over my body. By early that evening, I had a mild fever (100.3), significant increase in pain with the muscle/joint aches, and very tired. By midnight that night, my fever had broken and the majority of the achiness had subsided. By morning of 2/18, there was little to no more aches/pains, however, the lump on my arm at the injection site is still hard, warm to the touch, but significantly less painful. By mid afternoon, the bump has spread out but softened, skin is still warm to the touch.
41 2021-02-17 hot flush After the first vaccine, she started getting them a little/after the first vaccine, caller started t... Read more
After the first vaccine, she started getting them a little/after the first vaccine, caller started to have hot flashes again; She had a hormone reaction to it; affecting her mental health; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via an unspecified route of administration on 29Dec2021 at single dose for covid-19 immunization. Medical history included ongoing artificial menopause (Surgical menopause, since she was 36). The patient's concomitant medications were not reported. After the first vaccine, caller started to have hot flashes again, and after the second vaccine they became unbearable. She had a reaction to the vaccine. She had a hormone reaction to it. The caller did research herself to look up hormonal things about the Pfizer vaccine, but she could not find anything. The only information she found was on pregnancy and breast feeding, and low estrogen with COVID. They had significantly subsided over the last year and half to two years. After the first vaccine, she started getting them a little. Then, after second vaccine her hot flashes started being unbearable. She was unsure if it had to do with the vaccine, but she felt like it did. She spoke with nurses she works with. They too had hormonal issues after the vaccine. One had difficulty getting her period for 9 months to a year, but then got their period. She talked to people in menopause who have not had their period for a year, and had one after the vaccine. She talked to women with PCOS that had difficulty getting their period, but got their period after the vaccine. She also talked to women who had normal menopause, that hadn't had their period in a long time get a period. She said this was all generalized information. She doesn't have the specifics for the people that reported it. There was something hormonal going on. It was literally driving her nuts. Her first vaccine she got on the 29Dec2020, Lot number: EJ1686. Her second vaccine she got on 19Jan2021, lot number: EL9261. This all started a week after the first shot, and got worse after the second. She felt like this was medically significant. There was a fine line between medical issues and mental health, and she felt like this was affecting her mental health. Outcome of events was not recovered. Reaction assessed: after the first vaccine, caller started to have hot flashes again, and after the second vaccine they became unbearable. Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection; Drug result: Related.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-02-17 pain in extremity trouble lifting my arm; Pain in arm; Nauseous; Chills; Urge to cry; This is a spontaneous report fro... Read more
trouble lifting my arm; Pain in arm; Nauseous; Chills; Urge to cry; This is a spontaneous report from a contactable consumer who reported for herself . This 41-years-old no pregnant female patient received first dose of bnt162b2 (BNT162B2) from LOT# E19262, on 03Feb2021 17:30 on right arm at SINGLE DOSE for covid-19 immunisation .Age at vaccination:41 years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine . The patient received other medications within 2 weeks of vaccination .Medical history included :Allergy to adhesive, ADHD, high blood pressure (HBP), depression, anxiety, gerd. On 04Feb2021 20:00 the patient experienced chills, urge to cry, trouble lifting in arm , pain in arm and she was Nauseous. Events reported as non serious .No treatment received. Outcome was not recovered. Prior to vaccination the patient was not diagnosed with COVID-19Since the vaccination, the patient has not been tested for COVID-19
41 2021-02-19 flushing, pain in extremity, tenderness Dose 1: About 5 minutes after injection slight dizziness and ear felt stopped up. Later that night c... Read more
Dose 1: About 5 minutes after injection slight dizziness and ear felt stopped up. Later that night chest was flushed. Flushing lasted about 2 hours Dose 2: Due to flushing with last infusion, nurse told me to wait there 30 minutes after infusion. About five minutes after starting getting a headache and left ear was stopped up. Was told to take Benedryl if rash(flushing) came back with this infusion and to report symptoms to CDC. Headache and nausea felt till next day. Felt sick and headache riding in car. At 0130 am on 2/18/21 was awoken by pain under right arm. Very mild swelling noted but very sore to put arm down and tender to touch. Underarm still sore as of today Feb 20, 2021. Second day joint pain in shoulders, elbows, fingers, and knees. Joint pain improved but still there as of Feb 20, 2021. Ibuprofen and Tylenol did not help headache or joint pain. Third day headache off and on with nausea once, right hip pain. Feb 20, 2021 Fourth day underarm and joint pain improving , nasal and ear congestion
41 2021-02-20 feeling hot got Shot about 8:30; immediately after getting the shot, I had the same feeling as my breath being t... Read more
got Shot about 8:30; immediately after getting the shot, I had the same feeling as my breath being taken away and the taste (just like after getting an IV cleaned with saline). Nurses told me to sit up front to be observed and waited 30 minutes. After the 30 minutes, I began getting very warm (went outside to get fresh air); went to vehicle, took mask off face, was still feeling very hot, Face was bright red, lips were very red (looked like I had on makeup and I didn't have any on). Took 4 children's Benadryl (dissolvable). Went back to work. redness started to go away. Throughout the morning, I continued having the feeling of breath being taken away and the taste. It wasn't as bad, so I didn't worry. My lips were not too swollen, face was still swollen. I have had MANY reactions to food allergies and didn't wanna "cause" a scene. By 1:30, I was in a meeting trying to talk and my tongue started to feel thick and it was harder to talk. I took 2 adult Benadryl's and tried to work some more to keep my mind off of the reaction. I ended up being very tired and laid down. I slept till about 5pm and seemed okay after. Nothing else was done. My muscle was sore, no other symptoms.
41 2021-02-20 numbness, tingling extreme muscle pain for 24 hrs . started immediately as minimal and increase to extreme within 3 hrs... Read more
extreme muscle pain for 24 hrs . started immediately as minimal and increase to extreme within 3 hrs. face felt numb for about 20 minutes after receiving shot that lasted 15-20minutes. there was a tingling sensation present during the numbness in the center of my forehead. possibly related: experienced light nosebleed day after shot. three days after shot experienced a heavy nosebleed with very large clotting.
41 2021-02-21 feeling hot Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary reg... Read more
Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary region on same side as vaccination given, muscle soreness and pain of chest wall on same side as vaccination given, felt hot and prickly all over but not measuring fever, nausea. Symptoms started late Friday night after vaccination and are ongoing still as of Monday after receiving.
41 2021-02-21 flushing Flushing, tachycardia, lip tingling
41 2021-02-21 tenderness, breast pain Notice about 3 days after vaccine large painful lump in Left breast. By day 5 it was bigger and ver... Read more
Notice about 3 days after vaccine large painful lump in Left breast. By day 5 it was bigger and very painful. The lump took over a week to soften and go away. I am still tender with some swelling in the arm pit lymph notes.
41 2021-02-21 unresponsive to stimuli Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal ... Read more
Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal mentation within minutes and discharged without further treatment. History of similar responses to flu vaccine.
41 2021-02-22 difficulty speaking Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The followi... Read more
Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The following day she noted a low-grade fever. On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks. She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream. She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use. Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema. She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection. She took 2 Benadryl shortly after onset of these symptoms. This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow. Her throat felt scratchy. She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies. Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.
41 2021-02-22 pain in extremity, tingling, seizure Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache.... Read more
Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.
41 2021-02-23 hot flush, tingling Client c/o hot flashes on and off; tingling sensation L finger; slight difficulty of breathing; sl... Read more
Client c/o hot flashes on and off; tingling sensation L finger; slight difficulty of breathing; slight dizziness and states " feels like having anxiety."
41 2021-02-24 burning sensation About 5 minutes after receiving the shot, I experienced a tickle in my mouth, and then shooting burn... Read more
About 5 minutes after receiving the shot, I experienced a tickle in my mouth, and then shooting burning waves down both sides of my spine (just to the left and right) starting in my neck and settling in my groin. It felt like intense burning and buzzing waves going down from my neck. The paramedics came, said there were no signs of anaphylaxis, and took me to ER. They gave me benedryl and pepcid in an IV, I felt drowsy. The waves eventually subsided and were gone around the time of the benedryl (not sure if before or after).
41 2021-02-24 pain in extremity After the shot, I only had a slightly sore arm. Several hours later, after I had fallen asleep, I aw... Read more
After the shot, I only had a slightly sore arm. Several hours later, after I had fallen asleep, I awoke to sudden onset face swelling on my right side, severe and sudden sneezing and stuffiness, and a severe asthma attack. We called 911, and in the meantime I took 2 Benadryl and used my rescue inhaler. My breathing was assessed as diminished by the paramedics, and I was taken to the hospital. I was given oxygen and prednisone, and monitored. About 2 hours later I was released.
41 2021-02-24 seizure Seizure 2 weeks later with overnight hospitalization after not having seizure since 10/2016
41 2021-02-25 numbness, tingling Within 3 minutes, had facial tingling and numbness. Tongue felt ?thick? with it 30 minutes. Received... Read more
Within 3 minutes, had facial tingling and numbness. Tongue felt ?thick? with it 30 minutes. Received 50 ml injection at that time. All symptoms resolved within 5 hours.
41 2021-02-25 muscle twitching Within 45 mins of the first injection I felt dizzy and not myself. That night I had severe fatigue, ... Read more
Within 45 mins of the first injection I felt dizzy and not myself. That night I had severe fatigue, body aches, chills, and headache. I woke the following day with severe fatigue, headache and tachycardia. Five days out I had muscle twitching and lymphadenopathy. I had tachycardia with heart rate in 120-130s at rest and higher with exertion. I had sustained tachycardia for a solid two days and then intermittently for five days.
41 2021-02-25 pain in extremity Pain in the arm until last night, pain and severe dizziness since morning
41 2021-02-25 tremor, migraine, weakness Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance.... Read more
Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.
41 2021-02-26 pain in extremity patient that fainted today. She reported on her screening questionnaire of passing out after receiv... Read more
patient that fainted today. She reported on her screening questionnaire of passing out after receiving a injection. She was placed for 30 minute observation. The patient fainted several minutes after being seated. It was observed that she fell over from the chair and hit her head. Patient denied any symptoms other than her right toe being sore.. A + O x 4 medically stable. VS stable. EMS was dispatched due to patient hitting her head and c/o feeling dizzy still...however, patient declined services. She was with her husband and he agreed to drive her home.
41 2021-02-26 tremor Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The nig... Read more
Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The night of 2/25 (almost 6 days later) experienced flu like symptoms - chills, shaking due to cold, fever, thirst, joint and body aches, light headedness, fatigue. Morning of 2/26 chills and fever had subsided, had 8/10 severity headache that gradually decreased throughout the day. Body aches gradually subsided throughout the day and all symptoms were resolved by 6pm on 2/26. I had very similar symptoms after my first dose as well - initial injection 1/29 at 12:30pm, flu like symptoms began early morning of 2/1 that lasted about 15 hours.
41 2021-02-27 weakness Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms s... Read more
Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms subsided after 60 minutes. I also experienced dizziness and weakness right after taking the vaccine, which lasted for 24 hours. Other symptoms include tiredness, headache, muscle pain, chills, low-grade fever, and nausea, which have lasted for 24 hours and continue now.
41 2021-02-28 facial paralysis Bell's palsy; This is a spontaneous report from a contactable healthcare professional reporting for ... Read more
Bell's palsy; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9269/expiration date: not provided), via an unspecified route of administration, on 04Feb2021 08:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included attention deficit hyperactivity disorder (ADHD). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 14Jan2021 at 08:45 (at the age of 41 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced Bell's~ palsy. The event resulted in an emergency room/department or urgent care visit and received treatment which included CT scan, EKG, blood tests, and steroid prescribed. The outcome of the event Bell's palsy was not recovered. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Bell's palsy due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-02-28 flushing Immediate reaction, took over care, flushed and itchy progressed to facial swelling and difficult ... Read more
Immediate reaction, took over care, flushed and itchy progressed to facial swelling and difficult of breathing and was given EPI IM and Benadryl IV, transported Hospital.
41 2021-02-28 migraine Headache daily in the morning. On 2/26/21 developed a migraine with vomiting and went to ER. Today o... Read more
Headache daily in the morning. On 2/26/21 developed a migraine with vomiting and went to ER. Today on 3/1/21 continues to have headache every morning but not as severe and today has had 3 loose, watery stools.
41 2021-02-28 pain in extremity fever (102.3), sore arm, sore arm pits, headache, brain fog, chills, body ache, food aversion, nause... Read more
fever (102.3), sore arm, sore arm pits, headache, brain fog, chills, body ache, food aversion, nausea, fatigue
41 2021-03-01 feeling hot, flushing pt stated that soon after she received the covid vax she felt like the back of her neck was on fire.... Read more
pt stated that soon after she received the covid vax she felt like the back of her neck was on fire. She was flushed and itching. When she scratched her skin it would turn into a hive. Her eyes were swollen and looked bruised. She tried to eat a cracker but was not able to swallow. She became nauseous and winded. She went to the ER. Her entire back was red and inflamed. They administered Benadryl. Pt was released and to FU w/ PCP. That night she had some chills and fatigue. When she got up today 3/2/2021 she was super itchy, not able to swallow food and had diarrhea for two hours . She had a virtual appt w/ doctor and was referred to see her PCP. She made an appt w/ PCP. Her Dr. wrote her a RX for prednisone. Told her to take Benadryl as well and to stay off work for a couple of days.
41 2021-03-01 flushing S: 41 yo female c/o B/L arm redness from upper arm to finger tips, dizziness, mild throat tightness ... Read more
S: 41 yo female c/o B/L arm redness from upper arm to finger tips, dizziness, mild throat tightness and facial flushing after 16:10 after Pfizer vaccine that was given at 16:10. First dose of vaccine. No SOB. O: Pt flushed, arms reddened and feeling uneasy. B/P 130/100, Pulse 98. RA STATS 99%. RR 16. Lungs CTA. Benadryl 25 mg PO at 16:29, water and reassurance. B/P at 16:41 126/82, Pulse 94, SATS 100%, Lungs clear, B/L arms normal color. Hands remained chapped and reddened (too much hand washing per patient). A: Mild allergic reaction to Pfizer vaccine, first dose. P: 16:56, patient improved, refused further care, refusal form signed and instructions given for post care and worsening symptoms. Pt discharged to home via W/C to care. Instructed to F/U as noted.
41 2021-03-01 numbness Patient reported that within a "couple of minutes" of receiving 1st dose of Pfizer on 03/01/21 her ... Read more
Patient reported that within a "couple of minutes" of receiving 1st dose of Pfizer on 03/01/21 her face bilateral became numb in addition to her right arm and right hand. Patient stated after 5 minutes, she got feeling back in her face. As of 03/02/2021, patient states the numbness in her face and arm/hand is intermittent. Patient stated she still has full ROM.
41 2021-03-01 pain in extremity Sore arm Jaw pain Skin sensitive on face Headache
41 2021-03-01 tingling, burning sensation Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
41 2021-03-02 weakness, tremor Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, l... Read more
Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, lymph node under arm - near breast on side of vaccination swollen for 4 days. Headache Onset of chills began at 1am. Around 5am I started shaking and nauseous and I had not been able to fall back to sleep. 5am 2/25 until I woke up for the day 2/26 at 6am, I had the nausea, chills, weak. Lymph node swollen stayed for 4 days. I felt very confused, like I couldn't hold a full thought. No reaction to 1st vaccine except a sore arm
41 2021-03-02 facial pain, facial paralysis Patient received her second covid 19 vaccine on the 18th of February - about four hours after she de... Read more
Patient received her second covid 19 vaccine on the 18th of February - about four hours after she developed some soreness, fatigue and had a hard time moving her arm. Continued for a couple of days. Sunday 2/21 patient woke up without taste and her tongue was numb. That evening she began having some neck pain, below her ear, she massaged and didn't help all that well. At around 3 am that night, the pain was entirely on the right side of her neck and face, she took ibuprofen which mildly helped at night it was the entire neck. Monday 2/22 patient massaged area and it helped a little. She continued to have pain Tuesday 2/23 - Around 9am that morning patient noticed right sided facial drooping and her tongue was not working properly. She also noticed that her eye would not respond like her left eye. It was sluggish. When she went to brush her teeth, she noticed that the water would not stay in her mouth and it came out. At around 7pm that evening she went to the emergency room
41 2021-03-02 face paralysis, numbness, mild one side paralysis, facial paralysis, bell's palsy On 2/28/21 I began feeling numbness on the right side of my tongue and mouth. 3/1/21 numbness/weakn... Read more
On 2/28/21 I began feeling numbness on the right side of my tongue and mouth. 3/1/21 numbness/weakness began spreading to my right cheek and right side of lips. By 3/2/21 the numbness weakness covered the entire right side of my face and caused mouth and eye droop. Went to the ER and was diagnosed with Bell?s Palsy.
41 2021-03-02 flushing, feeling hot heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flush... Read more
heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flushed; felt very warm in the head and neck like was flushed; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9265) via an unspecified route of administration in the left arm on 30Jan2021 10:30 am at a single dose as Covid vaccine. Medical history included known allergies to penicillin- anaphylaxis. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Approximately 5 minutes after injection, heart rate suddenly increased and throat felt tight, and felt very warm in the head and neck like was flushed on 30Jan2021 10:45 am. It passed after a minute or two, then happened again around five times within the hour after injection. No treatment was provided for the events. The patient had no Covid prior to vaccination and has not had Covid tested positive post vaccination. The outcome of the events was recovered on Jan2021.
41 2021-03-02 night sweats flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a sponta... Read more
flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the left arm on 17Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included Seizure disorder, depression, anxiety, mild hyperthyroidism and Penicillin allergy. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included carbamazepine, citalopram, buspirone hydrochloride (BUSPAR), and omeprazole. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced flu-like symptoms, headache, aches, chills, night sweats, and more fatigue than normal on 17Dec2020 19:00. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The reporter assessed the events as non-serious. The patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
41 2021-03-02 pain in extremity, feeling hot face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really... Read more
face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.
41 2021-03-02 speech disorder Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. o... Read more
Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.
41 2021-03-03 depressed level of consciousness After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prio... Read more
After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prior to syncope. Patient was given epinephrine 0.3 mg IM x1 dose. Patient was difficult to arouse and a second epinephrine 0.3 mg IM was administered! EMS was called on seen and patient was taken to the ER where patient received fluids and zofran and was discharged. Husband confirmed the patient has phobia for shot/needles.
41 2021-03-03 night sweats Patient developed headaches and night sweats the day following the second vaccine administration and... Read more
Patient developed headaches and night sweats the day following the second vaccine administration and symptoms still persisting one month later.
41 2021-03-03 tingling, numbness With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in m... Read more
With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in my legs and tingling on my tongue. Took Benadryl - tongue tingling went away and the legs tingling and numbness was the same and started getting worse - they monitored my vitals and everything looked good and numbness remained. I had a driver and they allowed me to leave due to the Benadryl _ just took that one dose of Benadryl (didn't take anymore after that) and then the numbness in my legs remained for about two and a half weeks. I used a cane for two days. I had a fever and chills that first night, body aches and injection site pain and severe fatigue and those symptoms lasted one day except fatigue was for three days. The day after the shot was the worse of the symptoms. They followed up with me that evening and they followed up with me at work. I had the next dose - February 4, 2021 and experienced everything except the numbness in the tongue. Informal doctor visit because I work there.
41 2021-03-03 tingling After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in... Read more
After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in her arms and lips. She struggled to get up. Her breathing seemed fine but neck was red. She laid on floor with legs elevated until her dizziness subsided. She originally said she felt better but then dizziness returned. Called 911 and had Epi-pen ready. She was breathing fine when paramedics arrived. Her husband later called at 7:45pm and reported she was feeling fine. He said the emergency room gave her a steroid, anti-histamine, and pepcid. She is not going to receive the second covid shot. Her husband later stated she got a full body rash when she had covid. I also advised them to register on the v-safe site.
41 2021-03-04 flushing Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes th... Read more
Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes there was an increasing feeling of throat tightness. It started on the right side of throat, then the left a few minutes later. Eventually a feeling of pressure behind eardrums and a little trouble swallowing. Epi was given approximately 20 minutes after vaccine was administered, then a dose of Benadryl. Paramedics were called, transported to ED for observation for 4 hours. Symptom of tightness in throat improved within minutes of Epi, returned after a few hours with less severity. That feeling took a few days to completely subside.
41 2021-03-04 pain in extremity Constant dull pain throughout entire arm. Unable to lift the arm, limited back and forth movement.
41 2021-03-04 tingling About 10 minutes after her vaccine she started feeling throat thickness and was able to swallow so s... Read more
About 10 minutes after her vaccine she started feeling throat thickness and was able to swallow so she received 50mg of Benadryl PO. About 10 minutes later she said that she thought it was helping. About 20 minutes after the benadryl she started having dizziness/lightheadedness, visual field narrowing, worsening throat swelling with frequent throat clearing, and tingling in her hands, epinephrine pen given L thigh. After 5 minutes without improvement Epinephrine pen given R thigh. No rash/hives noted. Vitals were stable the entire time with SpO2 of 100%, RR 18-22, HR 84-98, BP 100-138/60-86.
41 2021-03-05 muscle spasms My left arm (site of injection on a Wednesday) began to ache within 4 hours of receiving the vaccine... Read more
My left arm (site of injection on a Wednesday) began to ache within 4 hours of receiving the vaccine. I took Tylenol to treat the pain and drank a lot of water. I woke up the next morning at 630am in extremely bad pain. My left lymph node under my arm was extremely swollen and tight, agony to touch. My entire left side from head to fingertips to toes ached at a level of 9 out of 10. My neck aches across both shoulders and my lower back aches across to my right side; the rest of my right side was unaffected. I took Tylenol every 6 hours which dimmed the pain to about a 6, but it would wear off 4.5 hours later, jumping back up to a 9. I eventually started taking Aleve later that evening to help at around 6 pm. I would become warm off and on, running a very low fever. I didn?t have any other symptoms other than the extreme pain, aches, and feeling drained. The next day (Friday) my pain had decreased to a 7.5-8, but my lymph node was still extremely painful and swollen. The pain continued to decrease the next day to a 5; Sunday was the last day of the left side body aches and lymph node swelling. However, the next morning (Monday) I woke to extreme lower back spasms/seizing. I went to the clinic at 1pm and was given a shot of Toridol and prescribed Voltaire?s and Flexiril. The doctor had me stay at home until Thursday, but the pain is only now starting to ease today, Saturday, March 6. I still have fleeting aches at the injection shot in my left arm.
41 2021-03-07 weakness 1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body ache... Read more
1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body aches, low grade fever, woke up early morning (6 or 7am) with nausea, weakness- husband had to help me to bed, headach by 4pm fever was getting higher, body aches and chills worsen. Called Telehealth for support and was advised to go to ER At ER arrived with high fever, full rigor, bones felt like they were breaking one by one so bad body aches, chills 1/12/21: First day of cognitive issues - sever fatigue, could not comprehend anything, could not work or do school 1/17/21: Realized the cognitive issues were bad and needed to see DR, dizziness, audio distorted, couldn't follow directions 1/18/21: First Dr apt at medical center Currently still in Dr's care 2/23/21: First Nuro apt with specialist
41 2021-03-07 cold sweat, weakness weakness, nausea, vomiting, chest pain, cold sweats, heart palpitations
41 2021-03-07 cold sweat, tremor Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; swea... Read more
Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
41 2021-03-07 difficulty speaking Pt called to inform our office that she received the covid-19 vaccine on 3/1 around 0950 and she dev... Read more
Pt called to inform our office that she received the covid-19 vaccine on 3/1 around 0950 and she developed itchiness, nausea and difficulty swallowing 1 hr after the administration on the Pfizer vaccine. Pt stated that she still has some difficulty swallowing but all other symptoms have resolved. Pt denies having chest pain, sob, throat itching, throat tightness or feeling of suffocation. Pt stated that she begin having hoarseness begin this morning which new onset. Patient sought care in ED room 3/1 and 3/4, follow-up visits with PCP and allergists. Unable to work.
41 2021-03-07 numbness, tingling Numbness et tingling et general stiffness to lower legs et hips
41 2021-03-07 migraine Extreme Migraine, nausea, puking,
41 2021-03-07 pain in extremity NAUSEA, PAIN ON THE LEFT ARM
41 2021-03-07 tingling o Complaint The patient is a 41 year(s) old Female complaining of o Chief Complaint Quote Patient st... Read more
o Complaint The patient is a 41 year(s) old Female complaining of o Chief Complaint Quote Patient states she got her COVID vaccine today and rapidly started feeling SOB, dizzy and feeling tired. Per EMS, patient did receive one IM of Epi. o Time Seen 02-17-2021 11:49 o Historian patient o Objective Statement 41-year-old female brought to the emergency room by EMS for allergic reaction. Patient says just prior to arrival she received first dose of her Covid vaccination. She said she was waiting after she received her vaccination when she began to have difficulty breathing, lightheadedness and nausea. She was given a IM dose of epinephrine and sent to the emergency department for further evaluation. In the emergency department, she says difficulty breathing has improved. She said she is now having some chest pain. She says pain is across the anterior chest, pressure-like. She said she also feels nauseous. Headache, throat tightening, rash, pruritus, abdominal pain, vomiting, diarrhea, dysuria, paresthesias or focal weakness. She has never had an allergic reaction before. Review of Systems Constitutional: Negative for chills, diaphoresis and fever. HENT: Negative for congestion, facial swelling and rhinorrhea. Eyes: Negative for discharge and visual disturbance. Respiratory: Negative for cough. Positive for chest tightness and shortness of breath. Cardiovascular: Positive for chest pain. Negative for leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, blood in stool and vomiting. Endocrine: Negative for cold intolerance and polydipsia. Genitourinary: Negative for difficulty urinating, dysuria and hematuria. Musculoskeletal: Negative for arthralgias, joint swelling and myalgias. Skin: Negative for rash. Neurological: Negative for speech difficulty, numbness and headaches. Physical Exam Nursing notes and vital signs reviewed. GENERAL: No distress HEAD: normocephalic, atraumatic EENT: PERRL, EOMI. Conjunctivae normal color, sclerae non-icteric; moist mucous membranes. There is no pharyngeal erythema or edema, uvula midline no stridor, patient handling secretions with no difficulty NECK: Supple, non-tender; no meningismus LUNGS: Patient in mild respiratory distress, tachypneic, lungs CTA. Normal air movement. HEART: Tachycardic with regular rhythm, no murmur CHEST: No deformity; non-tender ABDOMEN: The abdomen is soft, and non-tender, no masses or bruits. EXTREM: Normal ROM; no deformity, no calf tenderness. Normal pulses palpable in all extremities. There is no pedal edema. SKIN: No rash; no diaphoresis NEURO: Alert; normal speech and cognition; CN's grossly intact; strength grossly intact without focal deficit. BACK: No CVA TTP. o ED Course 1250: On reevaluation, patient resting comfortably in the room. She said she is feeling much better. She is no longer having any difficulty breathing. Chest pain has resolved. Her vital signs have normalized. She is no longer tachycardic. CBC shows a mild leukocytosis. CMP does show hypokalemia. On her EKG she does appear to have some U waves. EKG shows sinus tachycardia, no ischemic changes. Chest x-ray unremarkable. Potassium was repleted. On arrival, patient was given Benadryl, Solu-Medrol, Pepcid. She was given epinephrine at the vaccination site so no additional epinephrine was given here and at this point I do not feel she needs an additional dose. We will continue to monitor the patient in the ED. 1520: On reevaluation, patient is resting comfortably in the room. Her vital signs remained stable. She is not having any symptoms. No chest pain or shortness of breath. We will discharge the patient home. We will give her prescription for an EpiPen. Discussed warnings indications to return to ED. Told patient she should contact her primary care provider to discuss whether or not she should receive the second dose. Patient understands and agrees with the plan.
41 2021-03-07 slow speech, slurring, night sweats At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noti... Read more
At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noticing nausea, headache and a neck ache. Within 5 minutes of these symptoms, my tongue felt swollen and my speech was slowed and slurred. Within ten minutes of these symptoms occurring, my nausea went away as well as my swollen tongue and speech problems. The neck ache and headache progressed into a migraine. I took Tylenol and went to sleep. I woke four hours later with abdominal pain, nausea, head ache and neck ache as well as pain at the injection site. Again I took Tylenol. I experienced fatigue, migraine, neck and back ache, night sweats and axillary adenopathy over the next 5 days. Today is day 6 and I haven't gone a day without neck pain and headache yet. It usually occurs in the afternoon. I continue to take Tylenol and it feels better.
41 2021-03-08 flushing, burning sensation Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes,... Read more
Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes, face, abdomen Nauseous Pressure in head/face/ears Throat discomfort Headache Overall sick feeling Over the next couple days, my lips have broken out. I have some small mouth/tongue sores. Feeling of a cold coming on. Sinus pressure. Throat discomfort, congestion. Sneezing. Eyes burning. Face burning. Itchy patches on scalp. Face breaking out.
41 2021-03-08 tingling, numbness, bell's palsy On my way home from receiving my first vaccination my right side of my face started going numb and t... Read more
On my way home from receiving my first vaccination my right side of my face started going numb and tinging (like I had a dental procedure). This continued and progressed into my right arm. About an hour later tried to eat something and started coughing. Called public health and ask a nurse and was told to go to the ED for possible stroke. Was assessed and later discharged. Following up on 2/25/21 with primary care team. Was assessed and diagnosed with Bells Palsy and given steroids prescription to begin on Friday (2/26/21).
41 2021-03-08 tingling, numbness, pain in extremity, weakness Unsure if directly caused by vaccine, but wanted to report it just in case: Left arm pain, numbness... Read more
Unsure if directly caused by vaccine, but wanted to report it just in case: Left arm pain, numbness, tingling and weaknesses started on Monday March 1, Rash on left hand and upper body began on Wed March 5, diagnosed with Shingles on Thursday March 6.
41 2021-03-09 feeling hot I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw th... Read more
I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw that it was. After about thirty more seconds I had trouble breathing and eventually could barely breathe. My face was puffy and my eyes started to close. I received IV Benadryl and two other medications which I can't remember.
41 2021-03-09 numbness, weakness, tingling Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection s... Read more
Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021
41 2021-03-09 migraine Patient had pain: headache or migraine . Onsite EMS was called vitals BP 148/94 HR 54 100% O2. Pati... Read more
Patient had pain: headache or migraine . Onsite EMS was called vitals BP 148/94 HR 54 100% O2. Patient refused evaluation/care and released against medical advise.
41 2021-03-09 tingling, numbness Tingling, numbness, stiffness on left side of face, piercing pain behind left ear
41 2021-03-10 weakness, tingling, numbness Racing heart Numbness and tingling from mouth to toes Weak Dizzy/lightheaded Foggy Happened about 8... Read more
Racing heart Numbness and tingling from mouth to toes Weak Dizzy/lightheaded Foggy Happened about 8 times over 3 days
41 2021-03-11 bell's palsy Received EL0142 on 01/04/21 at 1:30PM and EL9292 (writing difficult to read) at 1:15 PM. Went to the... Read more
Received EL0142 on 01/04/21 at 1:30PM and EL9292 (writing difficult to read) at 1:15 PM. Went to the emergency room on 3/9/21 (43 days after 2nd shot) for symptoms of stroke. Was diagnosed with Bells Palsy.
41 2021-03-11 feeling hot Racing heart, heat inside my body from my shoulders through my arms and my stomach. Last maybe a min... Read more
Racing heart, heat inside my body from my shoulders through my arms and my stomach. Last maybe a minute. I didn't tell the pharmacist.;/ it went away but my mom.daodni should report it
41 2021-03-11 numbness Numbness in both feet for three days starting the night of my shot (March 4th). I had severe back ... Read more
Numbness in both feet for three days starting the night of my shot (March 4th). I had severe back pain for three days, which started on Friday, the 5th. Left foot is still completely numb 8 days later.
41 2021-03-11 pain in extremity, tremor 1/11/21- (24 hrs. after)- first vaccine, experienced mild body aches soreness in arm from injection ... Read more
1/11/21- (24 hrs. after)- first vaccine, experienced mild body aches soreness in arm from injection and slight fatigue. 2/1/21 (12hrs. after)- second vaccine experienced the following: chills/mild fever, body aches. (15-20 hrs. after) - visibly shaking with chills body aches comparable to the flu. Awoken by chills and shaking, fatigue. Fever broke, sweating 22 hrs. after receiving 2nd vaccine. Work in an office setting, was only able to stay 3 hours (0730-1030)due to exhaustion, body aches and generally feeling unwell. Day 2-6 sharp frequent headaches, and fatigue all other symptoms gone.
41 2021-03-11 pain in extremity Swelling and pain in left armpit on injected side (but can?t feel a lymph node), red rash and severe... Read more
Swelling and pain in left armpit on injected side (but can?t feel a lymph node), red rash and severe pain on injected arm, headache, muscle ache, joint pain, chills, stiff neck and shoulders with possibly inflamed lymph nodes.
41 2021-03-12 burning sensation Thursday evening I developed a burning sensation in the middle of my sternum/behind my sternum. It w... Read more
Thursday evening I developed a burning sensation in the middle of my sternum/behind my sternum. It was localized and did not radiate. It was not made worse by standing, sitting, laying, moving, eating, drinking. I was not short of breathe nor did breathing hurt. The pain was mild - a 2 to maybe a 3. Enough to know it was there but it did not limit me in any way. It has continued through the present. Saturday (3-13-2021) I started to notice a very rapid heart rate, from just walking across my house. I went down the basement stairs and walked up and I felt my heart was racing and pounding (this is something I do multiple times a day with ease). I have an oxometer and my heart was very high. I tried resting (by sitting) and my heart rate didn?t drop below the high 80s. I walked through a room and up a flight of stairs and down (in my home) and my heart rate peaked at 154 (wearing oxometer). My BP was also high for me 148/94. I called my primary care physicians office, spoke with a nurse that recommended I go to the emergency room. Tests were normal and I was released. The burning sensation remains. Since returning home heart rate gets high very easily and I can feel it pounding when I walk, though fortunately it hasn?t gone over the mid 130s. My blood pressure when checked at home was still high for me but quite a bit lower than when I first checked it at home. To be honest, I?m far from a pro at taking my BP so I?m not sure of the accuracy of either measurement.
41 2021-03-12 cold sweat Severe body aches, congestion, fever, chills, cold sweats. Feel like death.
41 2021-03-12 flushing, feeling hot After receiving dose, about 15 minutes after, at 1215, patient was getting ready to leave and she as... Read more
After receiving dose, about 15 minutes after, at 1215, patient was getting ready to leave and she asked if she was red and the lead clincian stated that she was red in her chest, patient face red and flushed. Patient then was escorted to the observation area she was experiencing itching, no tingling, and she was very warm. Patient was placed on the litter, and her blood pressure obtained in her right arm, 201/ 113, HR 98 and oxygen 100% She was observed for a total of 60 minutes. Her redness resolved, and she was feeling more comfortable after the 60 minute observation.
41 2021-03-12 numbness 2 minutes after injection, right arm went numb, heart racing at 120 bpm. High blood pressure. Then ... Read more
2 minutes after injection, right arm went numb, heart racing at 120 bpm. High blood pressure. Then irregular heart beat, rash on neck and chest. Nurses administered 50 mg Benadryl. 10 minutes later, heart racing again and inability to catch my breath. Dizzy and light headed. Irregular heart beat. Pulse ox was ok throughout. Total time of nurses observing these symptoms was 45 minutes. Two days later, still light headed and dizzy.
41 2021-03-12 numbness Heavy sweating, nausea, numbness in hands, dizziness, shortness of breath, fatigue. Lasted for about... Read more
Heavy sweating, nausea, numbness in hands, dizziness, shortness of breath, fatigue. Lasted for about 10 minutes. Still feeling very fatigued.
41 2021-03-12 tingling FEVER, MUSCLE PAIN, TIREDNESS, HEADACHE, SWELLING OF GANGLIA UNDER ARM AND NECK, SENSATION ON THE HA... Read more
FEVER, MUSCLE PAIN, TIREDNESS, HEADACHE, SWELLING OF GANGLIA UNDER ARM AND NECK, SENSATION ON THE HANDS AND LIPS WITH LIKE PADDING AND TINGLING. PAIN IN THE INJECTION SITE.
41 2021-03-14 facial pain, migraine Neck tightness on left side at 3:15 pm on 3/12/21 (30 min after vaccine) ice,, heat, and stretchin... Read more
Neck tightness on left side at 3:15 pm on 3/12/21 (30 min after vaccine) ice,, heat, and stretching Migraine with pain at base of neck up to sinus areas of face bilaterally, at 10:00 am on 3/14/21 until currently (4:30 pm 3/15/21) ice, heat, stretches, anti inflammatory, muscle relaxer, and cbd oil medications, chiropractor adjustment
41 2021-03-14 feeling hot 1/13 vaccination About 6 hours later, I started to feel hot, feverish, to feel really sick. I didn't... Read more
1/13 vaccination About 6 hours later, I started to feel hot, feverish, to feel really sick. I didn't think much about it. I went to work, thought was a sinus infection. Went home, and felt horrible. 1/14 didn't feel great but went to beach for my birthday. It went downhill from there. I got really really sick really fast. 1/17 rapid test; positive. *still very fatigue, hard to describe the feeling. I get winded really easy. **it really did affect me; 'put me in a dark place' / the mental part is really worse then the body part.
41 2021-03-14 feeling hot Patient received Pfizer COVID19 vaccine and went to the observation area. Others in the observation... Read more
Patient received Pfizer COVID19 vaccine and went to the observation area. Others in the observation area noted that she had a red rash on her chest. Patient noted that she felt warmth in area but no itching. She denied chest pain, shortness of breath, itching, oral mucosal swelling. She was given diphenhydramine 50m g by mouth one time. She was observed for 40 minutes in treatment area with improvement of redness and rash. Patient was stable when left the treatment area. She was instructed to go to ED if rash worsened or if she developed oral mucosal swelling, difficulty breathing/SOB. Recommended that patient consult her primary care physician and see an allergy specialist before getting her second dose.
41 2021-03-14 muscle spasms Injection occurred at 1:30pm Friday Severe stabbing muscle pain around ribs starting in the back int... Read more
Injection occurred at 1:30pm Friday Severe stabbing muscle pain around ribs starting in the back intercostal muscles around 8pm Friday. Muscle spasms and pain increased and spread to back and front intercostals as well as upper back muscles making it painful lay down or walk most of the day Saturday. Muscle pain made sleeping difficult Friday and Saturday nights. By Saturday morning the pain started to subside and spasms were only affecting lower intercostal muscles. By the time I woke up at 6am Sunday all pain was gone.
41 2021-03-14 pain in extremity, numbness and pain in extremities, cold extremities I received dose 1 of Pfizer COVID-19 vaccine on Feb 24. The initial symptoms starting Feb 25 were s... Read more
I received dose 1 of Pfizer COVID-19 vaccine on Feb 24. The initial symptoms starting Feb 25 were somnolence, mild muscle stiffness and dizziness that lasted approx 5-6 days but gradually resolved. Approx 3 days after the shot I developed chills, which took approx 2 weeks to resolve. As for neurologic symptoms, approx 6 days after the shot, I experienced a worsening of my peripheral neuropathy that is still ongoing >2 weeks since dose 1 (normally very mild at baseline and mostly limited to the feet). This exacerbation manifested primarily as stockings/gloves sensation to the mid-calves and elbows/mid-upper arms. I have also experienced some tingling in hand/feet and a notable cold sensation in the feet (worst in the toes- when I step into hot water in the shower, the feet/toes become quite painful and a transient blotchy redness appears on the feet). The stockings/gloves sensation and foot coldness persist though approx 50% better than when it started. No muscle weakness or myalgias accompany these symptoms. I am concerned about receiving my 2nd dose on March 26 given the ongoing presence of symptoms from the first. I have scheduled an appt to discuss with my Rheumatologist. My Neurologist is unsure I should receive 2nd dose.
41 2021-03-15 feeling hot Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn... Read more
Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn't breathe at 9:55am. She showed no signs of any breathing difficulty. Patient reported a past history of anaphylaxis to bee stings. At 9:57am 50mg of Benadryl was given. 9:58 am she reported she was sweaty, had blurred vision, and was hot. At 10:05, patient said she started to feel better. We asked that she wait the full 30 minutes. By 10:20am, she was feeling fine and the symptoms had resolved.
41 2021-03-15 tingling Within an hour of receving the vaccine, I became dizzy, had face tingling and arm tingling and felt ... Read more
Within an hour of receving the vaccine, I became dizzy, had face tingling and arm tingling and felt mentally foggy. As the day progressed, I felt a fullness in my throat and fatigue. Over the next week, the dizziness became worse, I experienced intense headaches and shortness of breath for several days. I had difficulty sleeping and vivid dreams. I have had thyroiditis twice in my life after giving birth to my 2 children with similar dizziness and throat fullness. I decided to contact my doctors and had my thyroid levels checked. My TSH was abnormal and my doctor thinks I could be having another episode of thyroiditis. My menstrual cycle arrived a week early. Following this, I continued to have dizziness, throat fullness, and intense headaches. I developed sore breasts and breast discharge as well as in increase in frequency of urination. I decided to postpone the second shot until I was feeling better as past episodes of thryoiditis took about 2 months to resolve. My next menstrual period was a week late, also accompanied by mood swings, breast tenderness and intense headaches. SIx weeks later, I continue to experience occasional dizziness and throat fullness and increased urination. Prior to the vaccine, I was feeling fine and it seems like the vaccine triggered some kind of hormone/endocrine response in my body. I have not had reactions to any vaccines prior to this. I am quite hesitant to receive the second vaccine and am wondering if I should wait a period of time and try something different such as the Johnson and Johnson one. I? not quite sure what in the Pfizer vaccine ( perhaps the mRNA?) could have triggered this reaction in my thyroid and endocrine system. and would appreciate guidance on what to do next as I would like to be fully protected from COVID-19 but do not want to endure these unusual side effects.
41 2021-03-16 burning sensation Swollen airway, head, and neck, intense itching and burning that lasted for 2-3 days
41 2021-03-16 feeling jittery I got my vaccination at 4pm, waited the 15 minutes at the united center waiting area and felt fine. ... Read more
I got my vaccination at 4pm, waited the 15 minutes at the united center waiting area and felt fine. I went home to pickup my daughter and at 6pm was back on the road driving and started to feel tired. I stopped at the light at foster and had just called my parents to tell them i had gotten the shot. I mentioned I was starting to feel tired and as I said it started to feel more tired. My mom responded maybe you should pull over and that was the last thing i remember as I fainted/blacked out immediately after. When I awoke my daughter (in the back seat along with my dog) explained that I had accelerated and hit the back of another car and then drove around that car, ending with both cars facing the direction of travel with my car in front of the car i had rear-ended. I was completely disoriented and had not recollection of hitting the gas or break much less driving. I was told two times that the driver in the other car was fine and was told when asked a third time that he did have some pain possibly and went in the ambulance to get checked out. I felt disoriented and jittery last night, took 2 Tylenol before bed and have felt fine today beyond feeling confused and horrible about what happen. My husband picked me up form the site and took me to my parents a few blocks north of the accident.
41 2021-03-16 night sweats It gets worse everyday, got vaccine on Sat morning and today is Wednesday- Headach, chills, stomach... Read more
It gets worse everyday, got vaccine on Sat morning and today is Wednesday- Headach, chills, stomach ach, night sweating, sleepless, shoulder ach
41 2021-03-16 pain in extremity Headache, drowsiness , body aches - 24 hours Sore Arm - 48 hours
41 2021-03-16 pain in extremity 45 minutes after the vaccine I started with all over body itching, had not eaten, drank or taken any... Read more
45 minutes after the vaccine I started with all over body itching, had not eaten, drank or taken anything between the shot and time of the itching. I did about 20 minutes after the shot have a headache, severe arm pain, and then later that evening I had body aches, and the lymph node under my arm swelled up. I am still having the arm pain, swollen lymph node and itching and its 5 days later. I have been taking my already prescribed allergy medications as well as Benadryl and Claritin as advised by my doctor.
41 2021-03-17 numbness - ten minutes after shot my top front teeth felt numb and I started to feel waves of hyper-awareness... Read more
- ten minutes after shot my top front teeth felt numb and I started to feel waves of hyper-awareness and disequilibrium that were accompanied with mild nausea. The numbness in teeth went away after approximately 5 min. The waves of disequilibrium continued for 24hrs, and now feel more like a pressure headache. During these ?waves? I also had increased heart rate. - an hour after the shot, my left arm felt numb down to the fingers. Then the right arm and upper back. This subsided after an hour.
41 2021-03-17 pain in extremity, nerve pain The injector could not get the shot in, and kept trying and finally after i heard a pop the shot go... Read more
The injector could not get the shot in, and kept trying and finally after i heard a pop the shot got in. Injection site is more towards side arm and shoulder. 3 hours after the second shot, I started to experience flu like symptoms, dizzy, achy, arm pain from awful injections, soar arm etc etc. The last 3 days I have experienced all symptoms that they say are normal, plus nerve pain running down my arm and across my chest to my other arm pit. Back pain, neck stiffness and just an overall feeling not good. I am concerned that there is damage from the injector not knowing what she was doing and now I am having a reaction to how she did the shot. Injection site is hot to the touch and bruised. My first vaccine I did experience dizziness and injection site looked like I was stung by a bee, very swollen but not hot to the touch like now. I have been on tylenol, which is doing anything so i switched to ibuprofen for pain, achinesss and overall just not feeling well. I cannot move my arm much, but can use my fingers. Today is day 4 of the same issues and at this point if my arm is not better by next week I will go see the doctor. My doctor has advised to report this, and ice areas and ibuprofen/tylenol. I am concerned I have nerve damage done at this point from whoever was the injector. I am hoping there is a way to find out who did mine. At the end of the appt, the injector did say sorry that was awful and I was so traumatized that I didn't even know what to do or say at the time. It was so bad my husband was getting his phone out to video but as soon as he did, she got it in deep where it was suppose to go????
41 2021-03-17 tingling Tingling in head, light headedness. Stated she is scared. Anxious. V/S 122/56, HR 72, O2 99%.
41 2021-03-17 throat numbness, numbness 30 to 40 minutes after vaccine a numbness creeped up the left side of my shoulder, then the left sid... Read more
30 to 40 minutes after vaccine a numbness creeped up the left side of my shoulder, then the left side of my throat/neck, then the left side of my face. It felt slightly numb, but was not paralyzed and i was able to see fine. It started to wear off after about 4 to 5 hours. Woke up in the morning and face seems back to normal.
41 2021-03-18 flushing Patient scheduled an appointment with her PCP, on 3/17/21. She presented with 2.5 weeks of flushing,... Read more
Patient scheduled an appointment with her PCP, on 3/17/21. She presented with 2.5 weeks of flushing, sweats, and intermittent pruritic hives since receiving her first COVID-19 vaccine on 2/27/21. She reports that the pruritis and flushing is worse with exercise. For one week, she has had a pink ovoid lesion 2-3 cm in length on right chin and left neck that are now scabbed without drainage. Neck and chin lesions treated with bactroban, patient is already on antihistamines, and instructed her to follow up if worse.
41 2021-03-19 flushing, tremor 3/20/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ... Read more
3/20/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: rapid heart rate, reported feeling flush, and was visibly shaking. Assessment : Time of assessment- 1845. Alert and oriented. Actions taken: Vitals sign taken at 1845 BP 139/84, P 74, T-98.2,R 16, O2- `100%, JUICE OFFERED AND ACCEPTED, RECHECK AT 1858, BP-156/75, P-116, DRINKING JUICE, AT 1918 BP- 131/82, P- 105, VS AT 1933 BP-113/59, P- 98, AT 1951- BP- 114/80, P-95, PATIENT FEELING BETTER AND LEFT WITH FAMILY. Medications administered: No medication administered. Disposition: PATIENT GIVEN INFORMATION OF ALLERGIC REACTION, AND ADVISED TO FOLLOW UP WITH PCP. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/19/2021 6:36 PM 0.3 mL 12/11/2020 Intramuscular
41 2021-03-20 flushing Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face... Read more
Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face, red eyes, red web like moving up and down the arms and legs, injection site rash.
41 2021-03-20 flushing Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generali... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Flushed / Sweating-Mild
41 2021-03-21 weakness Client was in the monitoring room after receiving first dose. Reported to the nurse felt like thro... Read more
Client was in the monitoring room after receiving first dose. Reported to the nurse felt like throat was swelling and having difficulty breathing and swallowing. Nurse reported client was visibly having a hard time with breathing. Client reported felt weak and legs felt "like noodles." Epi Pen given Left thigh. 911 called . Client accepted transport for further evaluation.
41 2021-03-21 feeling jittery Swollen eyes burning skin jittery feeling
41 2021-03-21 flushing, numbness, tingling, facial paralysis Face went immediately numb. Over the next several hours felt numbness in whole body. Facial drooping... Read more
Face went immediately numb. Over the next several hours felt numbness in whole body. Facial drooping. No paralysis, was able to move, minimal pins and needles, primarily a loss of sensation. It's 6 days later and I'm getting the sensation back but it hasn't fully returned. Facial flushing which continues to come and go, as well as flushing in hands and feet.
41 2021-03-22 weakness About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt ... Read more
About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt cloggd. Tachycardia, palpitations, nausea/vomitting, extreme Fatigue, weakness, headache, dizziness, and loss of memory. I had this type of episode 2-3 times over 5 days, lasting about 20-30 minutes, last one being at work, all of a sudden, same type of episode. Went to ER after Coworkers stated I was " in coherent " or in and out, my BP upon arrival to er was in the 160's/90's. They ran multiple lab tests, CT head, CXR and ECG. By the time I was dicharged my BP was normal I believe it was 116/81. Some side effects like nausea lasted a week, I was given an antinuasea prescription
41 2021-03-22 numbness, feeling hot, flushing Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into nec... Read more
Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into neck. Heart rate went up to 122bpm. Left side of face felt puffy and numb. Left side of mouth and tongue were tingling. Reported this to vaccine giver, he had me wait about half an hour before suggesting Benadryl. Half an hour after 25mg Benadryl, symptoms were almost completely resolved. The next day (3/14) I felt tired. The day after (3/15) I felt hot and my skin was flushed. I was not running a fever. I generally felt unwell that day. I felt better by the time I woke up on 3/16. I also had a bad/metallic taste in my mouth through 3/21, which has resolved. My nurse practitioner suggested that I take Benadryl before I receive my second vaccine dose on 4/3/21.
41 2021-03-22 numbness patient experienced numbness in L hand that comes and goes. first presented night of shot and has pe... Read more
patient experienced numbness in L hand that comes and goes. first presented night of shot and has persisted until now. patient taking aleve to help with pain associated with numbness
41 2021-03-22 migraine Severe headache (migraine) started within a few hours and has continued with daily headaches since f... Read more
Severe headache (migraine) started within a few hours and has continued with daily headaches since first vaccine. Additional migraine after second dose, continued to have daily headaches since.
41 2021-03-22 tremor Became extremely sleepy around 5 PM. Around 8 PM, started vomiting, diarrhea, fever, chills, shakes,... Read more
Became extremely sleepy around 5 PM. Around 8 PM, started vomiting, diarrhea, fever, chills, shakes, body aches. Felt better by 6 AM Saturday except sleepiness and body aches. Sleepiness/achiness stopped around 4:30 PM Saturday. Injection site sore from shot until Sunday evening.
41 2021-03-23 pain in extremity Had typical arm pain after an injection that was to be expected. I am now a month out from the secon... Read more
Had typical arm pain after an injection that was to be expected. I am now a month out from the second dose of the vaccine and I continue to have residual arm pain that is worse with movement. The pain is deep into the arm, almost like a bone pain. Rates 3/10 on pain scale. Noticeable decrease in strength in arm where vaccine was administered as well. I chose the dominant arm, as I am aware that the more the movement of the muscle the less likely the vaccine would pool in the muscle. I am an RN, I received vaccines through out my life time and I have never had a similar outcome. I typically do quite well with vaccinations. I had no other symptoms or reactions to either doses. Arm pain was significant with the first dose and did resolve fully. The arm pain with the second dose was increased in severity and then did decrease however it has not resolved. Concerned due to length of time that has passed.
41 2021-03-23 pain in extremity Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2,... Read more
Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2, highest 99.6. Also experiencing chills, lymphnode on left side of neck, little to no appetite, diarrhea, full body aches, dizziness, ringing in ears, knee pain, headache, nausea, sweating, tiredness. I have not been to work this week.
41 2021-03-24 weakness, tingling, numbness Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder an... Read more
Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-03-24 weakness RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "... Read more
RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "fait" in post-vaccine waiting room. At 2:05 with pt. experienced difficulty breathing. RN gave epinephrine 0.5ml pt. on R deltoid. Then, 911 was called. Pt. was examined by paramedics refusing to go to ER. RNs encouraged pt. to see PCP. Pt.'s husband was called by pt. for ride home.
41 2021-03-24 difficulty speaking Patient is a 41 Y female who presented today for COVID Vaccine c/o of scratchy throat, throat tightn... Read more
Patient is a 41 Y female who presented today for COVID Vaccine c/o of scratchy throat, throat tightness hoarseness, able to speak in full sentences, able to drink water without difficulty remains on RA no hives/rash noted, monitored closely. States throat tightness is resolving, remains on RA. 1133-patient states symptoms continue to resolve, and is ready to for discharge. BP 153/99 Pulse 81 Temp 97.4 °F (36.3 °C) (Temporal) SpO2 99%
41 2021-03-24 feeling of body temperature change Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperatu... Read more
Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-03-24 feeling of body temperature change Vaccine administered 3:10pm, reaction started within 5 minutes. Felt lightheaded and experienced hyp... Read more
Vaccine administered 3:10pm, reaction started within 5 minutes. Felt lightheaded and experienced hypertension (209/152), came down to 201/140, and again to 165/100. A pillow was placed under her and her legs/feet were elevated. While in our care, patient was provided and consumed 5 bottles of water and 2 packs of peanut butter crackers (pt is prediabetic and only thing she had consumed all day was a double espresso). She complained of oscillating between hot and cold... when she was cold she was provided a blanket. Patient refused our offer to call EMS. Patient consented to us reaching out to her physician, but they did not answer and patient refused our offer to leave a voicemail for her doctor. Patient left area and went to restroom to evacuate bowels and reported she felt significantly better. Patient stated she did not have a BP cuff at home and was provided both a BP cuff and acetaminophen and was advised to check her BP in a couple of hours. She walked out on her own and was advised to contact her doctor and that we would call her later that evening. When contacted that evening, she reported she was doing well.
41 2021-03-24 flushing Flushing Dizziness
41 2021-03-24 numbness Nausea, dizziness, numbness face and right arm, headache
41 2021-03-24 numbness Immediately L arm numbness, then whole L side numbness which was monitored for 30 mins post 1st dose... Read more
Immediately L arm numbness, then whole L side numbness which was monitored for 30 mins post 1st dose by on site healthcare person then released. Numbness subside by next day except near site. Next day grouped hives on whole L leg appears then disappears 2-3x in row for 1-2mins. On & off Chills and goose bumps on L side of body & fatigue, which dissipated after about 1-2wks.
41 2021-03-24 migraine migraine; This is a spontaneous report from a contactable consumer, the patient, reported for hersel... Read more
migraine; This is a spontaneous report from a contactable consumer, the patient, reported for herself. A 41-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN9261), via an unspecified route of administration in the left arm on 17Feb2021 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to BNT162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced migraine on 18Feb2021 at 15:00 and that lasted until Friday night on 19Feb2021. The patient did not receive treatment for event, migraine. The outcome of event, migraine was recovered on 19Feb2021.
41 2021-03-24 pain in extremity Arm pain.
41 2021-03-24 unresponsive to stimuli, flushing, numbness Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / L... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
41 2021-03-25 weakness Patient c/o generalize weakness. Pt verbalized that she had the same reaction with first dose. Pt.... Read more
Patient c/o generalize weakness. Pt verbalized that she had the same reaction with first dose. Pt. seen and assessed by EMT and assessments are as follows: BP 113/79, HR 79, O2 100%, BS 109. 17 minutes into observation client voiced that she had felt better and was cleared to go home by EMT.. Client advised to seek medical attentions if symptoms worsen.
41 2021-03-25 breast pain, pain in extremity Sore arm - started 2 hours after dose Headache - started 4 hours after dose Pain and swelling in lef... Read more
Sore arm - started 2 hours after dose Headache - started 4 hours after dose Pain and swelling in left armpit - started 26 hours after dose and continues; shooting pain down to fingertips, into left breast and down left side of torso.
41 2021-03-25 feeling cold This could certainly represent allergic reaction which she has had the vaccines in the past. She ha... Read more
This could certainly represent allergic reaction which she has had the vaccines in the past. She has sensation of tongue edema and scratchiness in her throat, does have erythema of her face and anterior neck, has mild wheezing on exam. She is treated with epinephrine 0.3 mg IM, followed by IV, Solu-Medrol 125 mg, famotidine 20 mg, Benadryl 25 mg, NS 1 L, and improves over several hours. At no point did she worsen or express a desire to have an additional epinephrine dose. She was never hypotensive. She is cold and chilled, also complained of nausea, given Zofran and a bear hugger While the wheezing was treated with albuterol inhaler and resolved Ultimately discharged with her husband They will be picking up a EpiPen in route to home which is at a pharmacy, confirmed Prescriptions sent for Benadryl, 3 additional days of prednisone, Pepcid, albuterol inhaler Last Set of Vital Signs: Temp: 37.2 °C (98.9 °F) Pulse: 96 Resp: 12 SpO2: 100 % BP: 132/76
41 2021-03-25 pain in extremity Redness, swelling, large knot/bump in arm at injection site about 2 in in diameter, Pain in arm when... Read more
Redness, swelling, large knot/bump in arm at injection site about 2 in in diameter, Pain in arm when touched or when I move it. headache & fatigue
41 2021-03-25 tingling Patient complained of tingling in vaccination arm
41 2021-03-25 tingling Warm and tingly all over and blurry vision
41 2021-03-25 throat numbness, tingling, numbness Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" star... Read more
Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" started and between 25-30 minutes my throat got "thick" and my body began tingling all over. My breathing became labored and difficult, my lips were numb. I was immediately administered an EPI pen, and was transported by ambulance to the ER . I was also treated with albuterol, solumedrol, and benedryl. I remained in the ER for the entire day, and was discharged in the evening. I was prescribed Claritin, and prednisone, and given an epi pen. I followed up with my doctor on the following Monday, still experiencing chest pressure and numbness/tingling in my throat/face. The Claritin was continued, and the prednisone was extended. I followed up with another doctor on Wednesday as symptoms were not resolved. Claritin has been increased and am trying to phase out the prednisone. I continue to suffer from tingling in my lips, and chest pressure. Doctors have no idea how long symptoms would last.
41 2021-03-26 nerve pain Pinched nerve pain, vitals wnl.
41 2021-03-26 pain in extremity Shot received 3/25/21. 3/26/21: fatigue, headache, pain in left arm and neck 3/27/21: rash on left a... Read more
Shot received 3/25/21. 3/26/21: fatigue, headache, pain in left arm and neck 3/27/21: rash on left arm and left leg, swollen lymph in left armpit
41 2021-03-27 tingling 2 days after 2nd dose all day moderate headache and nausea, 3 days after 2nd dose woke up at 4am wi... Read more
2 days after 2nd dose all day moderate headache and nausea, 3 days after 2nd dose woke up at 4am with tingling in lungs and shortness of breath.
41 2021-03-28 migraine Started with a headache. Next day migraine and bodyaches. Day after that Migraine worsened and in a ... Read more
Started with a headache. Next day migraine and bodyaches. Day after that Migraine worsened and in a lot of pain with body movement because of bodyaches.
41 2021-03-28 pain in extremity Follow up report: Dr had put me on a steroid tape for 9 days. My symptoms since coming off steroids ... Read more
Follow up report: Dr had put me on a steroid tape for 9 days. My symptoms since coming off steroids are very intermittent (lasts a few minutes and then it leaves)- maybe once or twice a day. The pain is pretty sharp - like a stabbing pain - primarily my feet and occasionally my hands.
41 2021-03-28 pain in extremity Intensely painful arm 10 days following vaccination. Most intense at Deltoid, strong in Bicep and r... Read more
Intensely painful arm 10 days following vaccination. Most intense at Deltoid, strong in Bicep and radiating down into lower part of extremity.
41 2021-03-28 tingling The day of the vaccination, I did feel feverish with chills. The next morning I felt well, but as th... Read more
The day of the vaccination, I did feel feverish with chills. The next morning I felt well, but as the day started to progress, I felt: sore arm at injection site, sore throat, dizzy, fatigue, tingling in fingertips of left hand, twinging in internal organs. Those symptoms went away 24 hours later. One week after injection, I developed delayed allergic reaction, with injection site swelling once again, and hives over my body.
41 2021-03-29 feeling hot EXPERIENCED WARM TINGLY FEELING IN THROAT
41 2021-03-29 feeling hot 41 yr/o female covid vaccinee this AM First dose of pfizer Medication and food allergy, but no vacc... Read more
41 yr/o female covid vaccinee this AM First dose of pfizer Medication and food allergy, but no vaccinee Throat tight, hot, scratchy Tingling sensation No swelling sensation No rash, itching No dyspnea, wheezing Got benadryl 50mg IM Mild improvement
41 2021-03-29 pain in extremity Driving home from the vaccine I had double vision and a feeling like I was going up and down in an e... Read more
Driving home from the vaccine I had double vision and a feeling like I was going up and down in an elevator. The next day I had the sore arm, aches and headache as expected. Sunday, started with carpal tunnel pain that extended from my left shoulder through my fingers as well as some vision issues where my eyes sort of had double vision again but I couldn?t blink it away for a minute. Monday morning I felt my right eye suddenly change vision where the one eye suddenly saw at a 45 degree angle. My husband said my eye looked ok but I could clearly see 2 of him and couldn?t blink it away for a solid minute or so. Today my eyes are blurry and I?m dizzy. I reported this to my doctor yesterday to see if what was happening was vaccine related and she asked me to report it here.
41 2021-03-29 pain in extremity I got fairly sick after the first dose with cold symptoms. They lasted about a week. The most severe... Read more
I got fairly sick after the first dose with cold symptoms. They lasted about a week. The most severe symptom was a sore throat that persisted the entire time. The second dose I didn't get any cold like symptoms, but my left arm was so sore, it sent pain along my back, neck and leg on the left side. The left underarm lymph node is severely swollen and hurts like hell. It's a little better the 3rd day after the 2nd shot, but it's still visibly swollen to look at and very tender to the touch.
41 2021-03-30 feeling hot Warm sensation throughout body within minutes of injection. Approximately 20 minutes after shot noti... Read more
Warm sensation throughout body within minutes of injection. Approximately 20 minutes after shot noticed a feeling of nasal congestion/sinus blockage. Approximately two and a half hours after shot low grade fever and mild headache. Approximately 3 1/2 hours after shot a short bout of ringing in left ear that lasted approximately 15 minutes. Approximately 67 hours after shot bouts of mild vertigo. Approximately 74 hours after shot bout of severe vertigo lasting approximately 3 hours and subsided to mild vertigo until the following evening. 3/31 sinuses finally cleared.
41 2021-03-30 hypersensitivity of all senses, breast pain, migraine Continuing a week after my vaccine- Painful armpit that felt like someone was scratching sandpaper o... Read more
Continuing a week after my vaccine- Painful armpit that felt like someone was scratching sandpaper on my armpit every time I moved, swelling of my left breast along with pain and sensitivity. After icing, I got it to go down but it was twice the size as normal, both of my hands and forearms being swollen every morning I wake up. The pain in my armpit has subsided but my breast is still very painful. Right after the vaccine for 3-5 days- chills, fever of 99.9-102.4, diarrhea, migraine headaches, lameness, and lethargic
41 2021-03-30 pain in extremity Lymph nodes swollen in throat starting immediately after shot and continued until current date 3/31... Read more
Lymph nodes swollen in throat starting immediately after shot and continued until current date 3/31/2021. Sore arm at injection site for first 3 days. Lymph nodes behind right ear swollen and painful starting 3/30/2021.
41 2021-03-30 tingling, discomfort pt. experiencing heaviness/tingling in the LVE. pt. denies any difficulty swallowing and/or oth... Read more
pt. experiencing heaviness/tingling in the LVE. pt. denies any difficulty swallowing and/or other signs/ symptoms. pt. advised to stay at the vaccination site an additional 15 mins to be monitored. pt. declined. pt. advised to f/u with her pcp/ call 911 if anything changes/ worsens. pt. verbalized understanding.
41 2021-03-31 weakness TIREDNESS, MUSCLE PAIN, CHILLS, SWEATS, JOINT PAIN, FAST HEARTBEAT, DIFFICULTY BREATHING, WEAKNESS ... Read more
TIREDNESS, MUSCLE PAIN, CHILLS, SWEATS, JOINT PAIN, FAST HEARTBEAT, DIFFICULTY BREATHING, WEAKNESS AND DIZZINESS
41 2021-03-31 burning sensation After receiving the 2nd dose of the Pfizer COVID vaccine, I was totally fine until about 16 hours la... Read more
After receiving the 2nd dose of the Pfizer COVID vaccine, I was totally fine until about 16 hours later. I woke up with a burning sensation in between my Shoulder blades, a fever, sweats, chills and body aches and severe joint pain. That started around 4:00am and was better around 1:00pm, but around 3:00pm noticed my lymph nodes felt swollen and my right arm pit was sore. Around 8:00pm, started to also feel achy again.
41 2021-03-31 depressed level of consciousness, tingling, difficulty speaking Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sens... Read more
Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
41 2021-03-31 feeling cold fatigue, cold. Evaluated by EMS-Cleared
41 2021-03-31 numbness Numbing along left arm (injection arm) and chest tightness.
41 2021-03-31 tingling, feeling hot While walking to the observation area after I got the vaccine, I became lightheaded and short of bre... Read more
While walking to the observation area after I got the vaccine, I became lightheaded and short of breath. I needed assistance to a chair. Things began to spin, voices sounded far away, I felt like it was hard to breathe and my throat began to close up. I felt really hot - my clothes were soaked with sweat and my husband (and the paramedics) said I was bright red. I genuinely believed I would pass out. When I sat for a minute with my head back I felt more stable. Then I felt like I had pins and needles all over my body, worst in my feet. The symptoms felt like they came in waves - once I sat down I felt less dizzy, but still struggled with my breathing. When one thing got better, another would intensify. After a couple of minutes my breathing felt much better and I got a metal taste in my mouth and my feet really hurt with pins/needles. The whole thing lasted about 8 minutes, when although I felt tired and my clothes were wet, my body felt safe and almost back to normal. I was surrounded by nurses and paramedics who monitored my vital signs and had medicine nearby, but never administered anything. My body recovered on its own and after 15 minutes I felt great and I gathered my things and drove home. The EMT who said goodbye encouraged me to call my doctor if I felt I was getting worse.
41 2021-03-31 tingling, numbness Numbness and tingling in three middle fingers of the left hand. Has continued on and off daily.
41 2021-03-31 tingling I am getting tingling sensations all over my face. Mostly the left side of my face it's been happen... Read more
I am getting tingling sensations all over my face. Mostly the left side of my face it's been happening off and on in random spots since the day I have had the shot which has been exactly two weeks now.
41 2021-03-31 tingling After 15 minutes c/o left sided headache, left neck pain, tingling in feet and felt like her "throat... Read more
After 15 minutes c/o left sided headache, left neck pain, tingling in feet and felt like her "throat was closing". Medicated with 60 mg Allegra as per vaccine protocol. O2 sat in 100%. Transported to ER in wheelchair in no acute distress.
41 2021-03-31 cold extremities "Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual received the Pfizer Covid-19 vaccine. She began t... Read more
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual received the Pfizer Covid-19 vaccine. She began to feel burning at site and body itching at 2:35 pm. Patient denied SOB of breath, dizzy, and was swallowing well. Her vitals were 150/96, 20, 72, 90/% at 2:40 am. Her fingers were cold unable to get a good pulse oxygen reading. Applied 2 L NC and gave Benadryl 50 mg IM in right Deltoid at 2:40 pm. B/P 152/94,18, 95 P, 95 % 2 L. 11:46 am. Individual called her doctor office. Dr. was given report of patient condition and advise patient to come to his office now or go to ER. Patients opt to go to physician's office. Individual stated she felt better, and her Sat's were 98% RA with no acute distress. 3:05 pm vitals 180/92, 20, 99, 98% RA. 3:15 pm Individual was escort to car with no noted distress.
41 2021-03-31 tremor Status post vaccine- hyperventilation, shaking. patient c/o trouble breathing had some patchy rednes... Read more
Status post vaccine- hyperventilation, shaking. patient c/o trouble breathing had some patchy redness to neck which resulted in epinephrine being administered IM per Dr. Epinephrine administered at 1831. BP 138/82 HR 78. PT was transferred to the local ER for further evaluation and was released at the ER.
41 2021-04-01 weakness, slurring Body aches and ringing in my ears started about 5 hours after the shot. I went to bed at 10pm thinki... Read more
Body aches and ringing in my ears started about 5 hours after the shot. I went to bed at 10pm thinking I was feeling ?fine?. I woke up at 1am, covered in sweat, nauseous and the room was spinning. I stood up because I thought I was going to throw up and lost consciousness. After a few minutes my husband called 911 because I was non responsive and vomiting. I gained consciousness as the paramedics were arriving, but had slurred speech and couldn?t see clearly. As they took me to the hospital I was awake and speaking but extremely weak. They did an ecg. At the hospital they did a blood test and ecg. They gave me an IV of fluids which helped. They had a hard time getting my blood pressure for the first few minutes, trying multiple cuffs. Ultimately, they said the echo looked ok, so they discharged me since I was no longer having an emergency episode and advised that I follow up with my primary and cardiologist
41 2021-04-01 migraine Severe nausea and Vomiting, excessive migraines that don't get better with any of my migraine medi... Read more
Severe nausea and Vomiting, excessive migraines that don't get better with any of my migraine medications or sleep, sleeping 14-18 hours a day, extreme muscle soreness, injection site pain, bleeding randomly from injection site, dark bruising at injection site, feeling dizzy and light headed upon any motion at all...even the slightest motion such as turning my head from one side of the pillow to the other.
41 2021-04-01 muscle twitching Intermittent muscle twitch in right mid upper thigh no pain or swelling
41 2021-04-01 pain in extremity sore arm, followed by redness and hot to the touch and swelling in axilla 3 days post vaccination tr... Read more
sore arm, followed by redness and hot to the touch and swelling in axilla 3 days post vaccination treated with tylenol and ibuprofen, suggested warm compress as well
41 2021-04-01 tingling, tenderness My skin has been itchy in various places since the first dose. My stomachs (upper and lower), My che... Read more
My skin has been itchy in various places since the first dose. My stomachs (upper and lower), My chest especially in-between my boobs and under them and my chest has broken out into red bumps when I itch it. I have a sensation of lactation in my breath even though I haven't been pregnant since 2017. My breaststroke feel cystic and swollen but my period isn't due. Lots of extra sensation in my chest. I feel more irritable. The itching has been every since my first Pfizer shot. I am sweating abnormally in my chest area. Daily. Since first dose. Arm had more tenderness with the first dose than the second.
41 2021-04-01 tingling Patient received 1st dose ofCovid vaccine & was anxious about receiving it. I gave the vaccine at 10... Read more
Patient received 1st dose ofCovid vaccine & was anxious about receiving it. I gave the vaccine at 10:40 & She started to have tingling in her hands about 15 mins after. I took her blood pressure at 11:00am because she was getting dizzy/lightheaded. It was 135/85 & her pulse was 85 so I believe she was getting more anxious. At 11:05 she stated that she was having trouble breathing, so I confirmed with her several times that she was having trouble breathing & gave EpiPen in left leg 0.3mg then called 911. She felt like she was breathing easier but was going to pass out so had her lay on her back with feet elevated until paramedics arrived.
41 2021-04-01 tenderness Pt developed headache, followed by fever up to 102, then had skin hot to touch, developed reticular ... Read more
Pt developed headache, followed by fever up to 102, then had skin hot to touch, developed reticular rash extending up to neck/shoulder area on right, and a soft lump that is tender on right side of neck/supraclavicular region. Rash resolving as of 4/2/21 but lump and tenderness remain.
41 2021-04-02 burning sensation Both inner thighs have been itching since about a week after first shot. 6 days after the second sh... Read more
Both inner thighs have been itching since about a week after first shot. 6 days after the second shot both inside thighs have softball size red, swollen patches that itcha and burn.
41 2021-04-02 difficulty speaking patient reports throat and tongue itching and tongue swelling and scratchiness of her voice, admitte... Read more
patient reports throat and tongue itching and tongue swelling and scratchiness of her voice, admitted to EC and given Benadryl, Solumedrol, morphine, and discharged home on same day.
41 2021-04-03 feeling hot Hot/warm feeling in left arm/neck. Vitals wnl. Benadryl 50 mg PO given.
41 2021-04-03 fibromyalgia, migraine My joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and... Read more
My joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes) was at a 5. Usually, my joint is at a 2. My right ankle became swollen. Usually, my ankles don't swell. I've also had four migraines during this time -- I typically have migraines every two to three months. I experienced fatigue which caused me to take multiple naps throughout the day. I experienced multiple days of brain fog, lasting up to 5 days at a time. Typically, I have brain fog for 2 - 3 days. Basically, I feel like I'm having a prolonged fibromyalgia and Sjogren's episode. The symptoms are still persisting.
41 2021-04-03 pain in extremity sore and swollen arm; sore and swollen arm; This is a spontaneous report from a non-contactable cons... Read more
sore and swollen arm; sore and swollen arm; This is a spontaneous report from a non-contactable consumer (patient). A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL9261; expiration date not reported), via an unspecified route (administered on right arm) at the age of 41-years-old on 22Jan2021 06:15 AM as single dose for COVID-19 immunization. Medical history included seasonal allergy and penicillin allergy both from unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19 and didn't receive any other vaccines. The patient is not pregnant at the time of vaccination. The patient experienced sore and swollen arm on 23Jan2021. The events were reported as non-serious. Since the vaccination the patient has not been tested positive for COVID-19. No treatment was received for the events. The outcome of the events was not recovered/resolved. No follow-up attempts are possible. No further information is expected.
41 2021-04-04 burning sensation 12 minutes after getting the shot my heart started to tighten, I got a burning sensation down my sho... Read more
12 minutes after getting the shot my heart started to tighten, I got a burning sensation down my shoulders, chest, neck and head. I felt like I was on fire. It went away and then came back. Went away and came back. I got light headed and passed out. I work up throwing up. I was taken to the ER. I was told I had a reaction to the vaccine. I?m still having symptoms and have a burning sensation off an on.
41 2021-04-04 numbness tachycardia and numbness to fingertips
41 2021-04-04 migraine Malaise, Headade like migrane, lgiht sensitivity, nausea, vomiting (3 times), shortness of breath
41 2021-04-04 pain in extremity Heart racing and pounding 30 minutes after injection. Intermittent heart pain, heart pressure, left ... Read more
Heart racing and pounding 30 minutes after injection. Intermittent heart pain, heart pressure, left arm pain, palpitations, heart fluttering continuing for 10+ days following vaccination. EKG revealed short PR interval of 110.
41 2021-04-05 burning sensation, numbness, tingling I waited the 30 min for high risk and about 5 min after I left my face started burning like I had a ... Read more
I waited the 30 min for high risk and about 5 min after I left my face started burning like I had a bad sunburn, started tingling and felt numb. Took Benadryl before bed. Woke up face slightly swollen and a little tingly. By 8am my tongue started tingling. Took 2 Benadryl and scheduled an apt with my PCP. Apt at 1:30 with PCP. Redness across chest & on & off tingling in face, lips & tongue. Slight swelling noticed by the doctor steroid shot & told to continue Benadryl & add pepcid. Still slight face, lips & tounge tingling & swelling.
41 2021-04-05 burning sensation Vaccine was administered in drive thru. I pulled out after and into one of the waiting spots. About ... Read more
Vaccine was administered in drive thru. I pulled out after and into one of the waiting spots. About 10 minutes after I was suddenly drenched in sweat and started to see black. My left side of body started to feel a burning sensation. I had been told to honk and put on flashers if anything went wrong. I did and waited more than 30 minutes. No one ever came to check me. After about 10 more minutes I started to feel better but was still pale and my face looked slightly puffy. I never saw anyone so I eventually drove home, drank a ton of water, ate some saltines and then slept a little. Had chills off and on that day and remained tired the next day. Felt fine by day 3
41 2021-04-05 nerve pain I felt fine immediately after my second vaccine; about 12 hours later, I woke up due to the most ex... Read more
I felt fine immediately after my second vaccine; about 12 hours later, I woke up due to the most excruciating, electric nerve pain in my right ankle - any of the slightest movement or touch caused this nearly unbearable pain. It lasted constantly for about 6 hours (I got a little relief from keeping a heated blanket wrapped around my ankle and foot). The extreme pain finally subsided 6 hours later, and I developed a fever between 99-100 degrees that lasted another 15 hours. By the following morning, the fever was gone, but I still have remnants of this severe ankle pain that come and go seemingly without cause. I have not experienced any recent injuries etc that I can associate with this. The only thing I can think of is when I was 16 years old, this foot was run over by a car and I sustained nerve damage, for which I received extensive physical and nerve therapy that healed the injury. I have never had any problems with this area, and certainly never this level of pain, until now. I went to my chiropractor yesterday, but got no relief. Tomorrow I have a physical therapy appointment; my chiropractor encouraged me to report this incident
41 2021-04-05 pain in extremity extreme arm and shoulder soreness, painkillers ineffective, throbbing, unable to sleep due to pain
41 2021-04-05 tingling, numbness, flushing during injection she had pain in left side of neck. about 1 hours after, she developed blurry vision... Read more
during injection she had pain in left side of neck. about 1 hours after, she developed blurry vision in left eye and numbness to left jaw and cheek area. took 50mg benadryl and used ice pack. in the morning she noticed swollen left side of face and continued numbness, tingling, which includes some near her eye. some flushed skin to area. Denies facial paralysis or weakness. Her eye no longer has blurry vision.
41 2021-04-05 seizure Pt had syncopal episode and seizure following first dose of covid vaccine, resulting in calling 911,... Read more
Pt had syncopal episode and seizure following first dose of covid vaccine, resulting in calling 911, transferred to the ED
41 2021-04-05 tremor, weakness Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Weakness-Severe, Additional Details: Vaccine and Epi-pen administered by RN - 618-830-0993
41 2021-04-06 weakness Dizziness, weakness, in 5 min. of receiving vaccine. VS 121/86, HR 86, O2Sat 100%. 11:30am Patient... Read more
Dizziness, weakness, in 5 min. of receiving vaccine. VS 121/86, HR 86, O2Sat 100%. 11:30am Patient stated feeling much better and left.
41 2021-04-06 numbness Hives and allergic rash on face and neck with feelings of numbness and acute sneezing. 50mg of oral ... Read more
Hives and allergic rash on face and neck with feelings of numbness and acute sneezing. 50mg of oral diphenhydramine given at 11:30 am. Hives on neck responded to oral diphenhydramine within 15 minutes. Client remained in observation area for another 15 minutes and was then discharged with her spouse driving the vehicle. Advised that 2nd dose should only be given upon review and approval of her physician, in a medical environment. Assessment: mild/moderate allergic reaction to COVID 19 Pfizer vaccine in a client with a history of allergic reactions to other things. MD.
41 2021-04-06 pain in extremity - w/in 15 min nausea and slight vertigo. Soreness in left arm. - w/in 45 min nausea & vertigo wen... Read more
- w/in 15 min nausea and slight vertigo. Soreness in left arm. - w/in 45 min nausea & vertigo went away, soreness travelled into left side of neck/head & jar. Sinus pressure and then difficulty swallowing. - w/1n 60 min itching (no hives) and periodic difficulty swallowing - w/in120 min all symptoms dissipated except for slight soreness in left arm.
41 2021-04-06 pain in extremity Headache, body aches, fever, arm soreness
41 2021-04-07 difficulty speaking tightness in chest, tightness in throat, hoarseness burining sensation in throat 50 IM Benadryl give... Read more
tightness in chest, tightness in throat, hoarseness burining sensation in throat 50 IM Benadryl given in right arm
41 2021-04-07 flushing Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Aller... Read more
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild
41 2021-04-07 migraine Fatigue, migraine got worse, dizziness, irritability, lightheaded, blood pressure and heart rate wen... Read more
Fatigue, migraine got worse, dizziness, irritability, lightheaded, blood pressure and heart rate went up
41 2021-04-07 muscle spasms Fever, chest tightness, muscle cramping, body aches, headache, extreme fatigue.
41 2021-04-07 pain in extremity Passed out 6 hours after shot, not normal(3rd shift worker), fever set in 10 hours after shot, heada... Read more
Passed out 6 hours after shot, not normal(3rd shift worker), fever set in 10 hours after shot, headache set in 18 hours after shot, fever subsided 18 hours after shot, currently experiencing constant sweating(rarely sweat even in heat), woke up with two hives on left arm that have gone away since I noticed them itching, right arm soreness, actual pain in right armpit.
41 2021-04-07 tingling, feeling cold, pain in extremity My arm started feeling sore almost right away, it got worse over the first day and then felt somewha... Read more
My arm started feeling sore almost right away, it got worse over the first day and then felt somewhat better April 7. Almost completely resolved by the morning of April 8. The evening of April 7, I started feeling some tingling in my face and in the left arm. There were also waves of coolness in my arm, neck, and back region. They are still happening the morning of April 8. Extenuating circumstances: I received word my mother fell and broke her hip the day of April 7, and my sisters and I were discussing options for her treatment around the tingling started.
41 2021-04-07 tingling, flushing Approximately 45 minutes after shot administration, patient began to feel light headed, dizzy, and ... Read more
Approximately 45 minutes after shot administration, patient began to feel light headed, dizzy, and onset of flushed face and ears, nausea. She was still onsite and presented to facility's ED. She presented to the ED at 11:22, there she started to experience a thick throat that was phlegmy, a blotchy rash down back and across chest. Also noted from ED MD other symptoms she was experiencing tingling in her fingers and hands, she began to hyperventilate and a tight feeling in her throat. Her medical course of treatment was labs were drawn at 11:28. Epinephrine administer subq at 11:30, iv fluids (sodium chloride) started 11:40, DuoNeb at 11:45, diphenhydramine HCl and methylprednisolone administered at 11:51, and famotidine at 11:56. Outcome: all treatment gave positive results, symptoms much improved, and patient was monitored for any further development and was discharged at 13:25.
41 2021-04-08 weakness migraine that lasted more than five hours, accompanied by confusion, and extreme lethargy. Lethargy,... Read more
migraine that lasted more than five hours, accompanied by confusion, and extreme lethargy. Lethargy, feeling faint, chills, and weakness continued for over 24 hours. Extreme fatigue and mental fogginess still persistent, impeding all day-to-day activities.
41 2021-04-08 muscle spasms, pain in extremity Vomitting, diarrhea, muscle cramps' extreme leg pain
41 2021-04-08 pain in extremity Got Pfizer-BioNTech COVID-19 Vaccine EUA about 5:55 pm on Thursday April 8th. Started to feel sorne... Read more
Got Pfizer-BioNTech COVID-19 Vaccine EUA about 5:55 pm on Thursday April 8th. Started to feel sorness after 10 minutes at the shot site. 3 hours after got like a whoosh sounds in ears. Sore left arm. Went to bed. Woke up with a headache and feeling drowsy. took acetaminophen at 9am. Headache is gone. Still drowsy. It is 2:15 pm on Friday april 9th. And whoosh sounds in ears came back like 30 minutes ago.
41 2021-04-08 pain in extremity Patient began feeling pain in her legs that woke her up several times at night and into the morning.... Read more
Patient began feeling pain in her legs that woke her up several times at night and into the morning. Walking helped to prevent serious pain. Offered that she get electrolytes and magnesium and contact her doctor.
41 2021-04-08 tingling Arm given shot kept ?falling asleep? for 24hrs following shot
41 2021-04-09 difficulty speaking woke up and had lost voice (very hoarse) for a week after; Body aches night of vaccine; This is a sp... Read more
woke up and had lost voice (very hoarse) for a week after; Body aches night of vaccine; This is a spontaneous report from a contactable other hcp reported for herself. A 41-years-old female patient received First dose of BNT162B2 (Pfizer-Biontech Covid-19 Mrna Vaccine, Formulation: Solution for injection) via an unspecified route of administration, in right arm on 12Jan2021 at 10:00 (Batch/Lot Number: Eh9899) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); dexamethasone (ZINE [DEXAMETHASONE]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Patient was not allergic to medications, food, or other products. On 12Jan2021 at 03:00, The patient experienced body aches night Went away next morning of vaccine and but woke up and had lost voice (very hoarse) for a week after. No treatment was received for the adverse event. On 13Jan2021, the outcome of the event pain was resolved and on an unspecified date the event Hoarseness of voice was resolved.
41 2021-04-09 flushing Patient came to Vaccine POD to receive first dose of Pfizer vaccine (LOT #ER8731, Expires 07/2021) o... Read more
Patient came to Vaccine POD to receive first dose of Pfizer vaccine (LOT #ER8731, Expires 07/2021) on 4/10/2021. Patient has a medical history of hypertension and has allergies to ibuprofen and penicillin. Patient received approval from her doctor and specialists to receive Pfizer vaccine. The patient gave verbal consent to receive the Pfizer vaccine and was vaccinated at 1459 by RN. The patient was given an observation time of 30 minutes with RN, who was performing the EMT observer role on site. At 1530, the patient reported experiencing "tingling" in her lips and tongue. Lead RN was called to assist with the patient. The patient presented with redness localized on face. The patient was assisted to anti-gravity chair at 1531. At 1532, the patient's vitals were taken by RN: BP 160/90, HR 83 BPM, RR 21/min. RN administered 50mg/1mL Benadryl IM in the patient's right arm at 1537. The patient denied difficulty breathing. The patient's vitals were reassessed every 5 minutes for 30 minutes. The patient remained A&Ox4 throughout 30 minute observation period. The patient's vitals at 1538 were: BP 200/118, HR 88 BPM, RR 22/min. The patient states she forgot to take her blood pressure medication in the morning. She states her baseline blood pressure is around 160 systolic. At 1543, the patient's vitals were: BP 160/102, HR 90 BPM, RR 22/min. Visibly, the patient was less flushed. Patient was able to look at herself through her cell phone camera and pallor returned to normal limits, per patient. At 1548, the patient's vitals were: BP 155/108, HR 83 BPM, RR 20/min. At 1553, the patient's vitals were: BP 160/102, HR 79 BPM, RR 18/min. The patient states the tingling in her lips and tongue has resolved. The patient sat up with her feet dangling below her, her vitals were as follows: BP 167/110, HR 79 BPM, RR 17/min. The patient reported "feeling better" and requested to drive herself home. RN provided patient with education about side effects of Benadryl, including fatigue. Patient states she is unable to find a ride and must drive herself home. Patient states she is "feeling fine" and lives "3 minutes away". The patient was given education related to when to seek medical care, including shortness of breath, chest tightness, and sensation of throat tightness. The patient demonstrates understanding of teaching and states she will call her doctor if her symptoms worsen. The patient's gait was steady and patient denied any dizziness or lightheadedness. At 1601, the patient requested to drive herself home. She was escorted to her car by RN. Upon departure, patient was ambulatory, A&Ox4, with no reports of trouble breathing, dizziness, or lightheadedness. Patient drove herself home AMA at 1604.
41 2021-04-09 pain in extremity Approx. 36 hours after the first shot, I noticed an intense ringing in my ears that has not gone awa... Read more
Approx. 36 hours after the first shot, I noticed an intense ringing in my ears that has not gone away. For the first 48 hours I also experienced dizziness, confusion, mood swings, and soreness in my arm. I still have occasional dizziness and mild vertigo.
41 2021-04-09 pain in extremity First dose, fever of 103.2 F; Chills; sweating; fatigue; headache; muscle pain; arm pain; insomnia; ... Read more
First dose, fever of 103.2 F; Chills; sweating; fatigue; headache; muscle pain; arm pain; insomnia; nausea; This is a spontaneous report received from a contactable other-HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number :UNKNOWN) via an unspecified route of administration in left arm on 17Feb2021 at 05:00 PM (at the age of 41-years-old) as single dose for covid-19 immunization. Facility type vaccine was Hospital. Patient medication history included severe preeclampsia, Patient allergic with penicillin and concomitant medications as ibuprofen (IBUPROFEN), Zolpidem tartarate (AMBIEN) and paracetamol (TYLENOL) were reported. AE resulted in: Doctor or other healthcare professional office/clinic visit. On 18Feb2021 at 03:30 am, the patient experienced fever of 103.2 F, Chills, sweating, fatigue, headache, muscle pain, arm pain, nausea, insomnia. Treatment was given for events. The outcome of the events was recovered. Information about lot/ batch number has been requested.
41 2021-04-10 burning sensation, breast pain Burning in arm immediately following injection; heaviness/?dead arm? for 36 hours; muscular pain on ... Read more
Burning in arm immediately following injection; heaviness/?dead arm? for 36 hours; muscular pain on left side from breast area into front and back chest I left. Swollen lymph nodes and pain around left breast and armpit area, into back shoulder blade, lasting more than 10 days.
41 2021-04-10 cold sweat Nausea High fever up to 102.4 lasting about 4 hours Fever lasting over 24 hours Cold sweats Loss of ... Read more
Nausea High fever up to 102.4 lasting about 4 hours Fever lasting over 24 hours Cold sweats Loss of appetite
41 2021-04-10 feeling cold 1st dose- left arm pain and left clavicle area, two days 2nd dose- right arm. Hot painful rash on a... Read more
1st dose- left arm pain and left clavicle area, two days 2nd dose- right arm. Hot painful rash on arm at injection site. Mimicking cellulitis. Day two, felt very cold unable to warm up despite adding several layers. Arm reaction lasted 7 days.
41 2021-04-10 flushing Tachycardia, Hypertension, feels flushed,
41 2021-04-10 muscle spasms Significantly early and heavy period, cramping, fatigue
41 2021-04-10 pain in extremity Felt lightheaded/dizzy within 60 seconds of receiving shot. This feeling dissipated after 5-10 minut... Read more
Felt lightheaded/dizzy within 60 seconds of receiving shot. This feeling dissipated after 5-10 minutes. Other side effects were expected or listed as common; a sore arm (began day of shot, lasted about 2-3 days) and nausea (began 2 days after shot, lasted 3+ days).
41 2021-04-10 pain in extremity Arm pain, headache, diarrhea, dizziness, fatigue (2 days). Started period 2 day early and had very h... Read more
Arm pain, headache, diarrhea, dizziness, fatigue (2 days). Started period 2 day early and had very heavy period with bad cramps.
41 2021-04-10 tingling, burning sensation, pain in extremity Pins and needles in mouth and tongue 1 day following vaccine. Continued worsening until going to ER ... Read more
Pins and needles in mouth and tongue 1 day following vaccine. Continued worsening until going to ER April 10th, pins and needles and burning all over body for a full day period. Continuing to get worse. Have been referred to rheumatologist and neurologist, but no one knows what is going on or how to treat. Only tell me ?I am not the only one?. Feels like arthritis in hands. Pain mostly in mouth, tongue, spine, feet, legs.
41 2021-04-11 feeling hot Following symptoms were experienced about 7 minutes aster receiving the vaccine: Feeling of warmth i... Read more
Following symptoms were experienced about 7 minutes aster receiving the vaccine: Feeling of warmth in abdomen followed by increased heart rate and palpitations. HR 148/min (normal resting heart rate 50-60/min). Blood measure 150/100 (baseline around 115/80). Also feeling of dry mouth. Observation prolonged - BP dropped to 130/90 after about 30 minutes, HR dropped to 80. Episdoes of increased HR kept re-occurring for about 2 hours after the shot. No respitatory distress or cutaneous symptoms. After about 90 minutes after the vaccine, feeling tingling in lips and scratchy throat. Administered Benadryl 25mg per mouth, lip tingling and scratchy throat resolved within 30 minutes thereafter. All of the above symptoms resolved about 4 hours after the vaccine, HR at 60. Following symptoms developed within 12 hours of the vaccine: Chills, fever (100F), myalgia, artralgia, fatigue, nausea. Treated with ibuprofen and acetaminophen, resolved about 48 hours after the vaccine. Note: No known history of Covid.
41 2021-04-11 feeling hot has a bulge in her (L) clavicle, it's gotten a little bit bigger and feels warm. No PCP/no insurance... Read more
has a bulge in her (L) clavicle, it's gotten a little bit bigger and feels warm. No PCP/no insurance to be seen by a doctor. I suggested to keep monitoring and to apply a warm compress on it. Will follow her one more day before closing case. Follow up call by Spanish interpreter on the line as well as patient, patient still has lump on collar bone but tenderness has decreased, was recommended by cvs clinical staff to apply Icy hot and warm compress CVS clinical staff will see her on Friday.
41 2021-04-11 feeling hot Large knot on right arm-massage therapy, tylenol Knot still has fever in it and is hot, sore, swolle... Read more
Large knot on right arm-massage therapy, tylenol Knot still has fever in it and is hot, sore, swollen
41 2021-04-11 hot flush Patient states after the vaccine, she developed wheezing, shortness of breath, headache, cough, and ... Read more
Patient states after the vaccine, she developed wheezing, shortness of breath, headache, cough, and hot flashes. She states her chest feels tight, but denies any irritation or swelling in her throat.
41 2021-04-11 numbness, tingling She states that 1 minutes after receiving the COVID vaccine in her right shoulder, she noticed incre... Read more
She states that 1 minutes after receiving the COVID vaccine in her right shoulder, she noticed increased pain, swelling, itching, redness at the site of the injection. She also noticed that her right shoulder became numb and tingly which spread into her upper neck, distal right arm and right lower extremity. She also endorses numbness of the right side of her face and mouth. She denies any muscle fatigue or weakness. She states that after receiving the vaccine she became dizzy and lightheaded upon standing but denies any loss of consciousness.
41 2021-04-11 numbness, tingling Reports to virtual urgent care one day after 1st pfizer covid vaccine with pain in left neck , blurr... Read more
Reports to virtual urgent care one day after 1st pfizer covid vaccine with pain in left neck , blurry vision, left facial numbness immediately after. The next day face is still numb/tingling/red. No other symptoms. Advised to follow up with PCP or go to ED if symptoms worsen.
41 2021-04-11 pain in extremity At the time of the shot I felt the stuff going into my system and all the way down my whole right si... Read more
At the time of the shot I felt the stuff going into my system and all the way down my whole right side all the way down to my right leg. It wasn?t painful or anything I was just aware that something was just injected into my body. About an hour after my injection I had a pain go into my hand a few times and I had to keep moving it around to make it go away which it did. That night had neck pain. That night I woke up to a pain in my right calf muscle and I thought I was going to get a Charlie horse so I got up and walked it off. It never got as bad as a Charlie horse. So I went to sleep and not much longer I woke up to the same thing in my left calf muscle. So I got up and walked around. Next morning Same thing happened. So I called the place I got the shot and they suggested taking magnesium pills and electrolytes as well as did my Dr Office. So I did that. Two days later I was feeling a pain in my left back shoulder blade. It eventually went away. I was worried about blood clots, but idk what caused this? Had diarrhea for a few days. And sweats the next morning. I?m day 5 into the first shot of Pfizer right now. I?m worried if I should get the second shot because of the leg cramping.
41 2021-04-11 tingling, unresponsive to stimuli Patient was in her 15 minute wait after vaccination, and complained of swelling, itching, tingling, ... Read more
Patient was in her 15 minute wait after vaccination, and complained of swelling, itching, tingling, difficulty in breathing, coughing and gagging while in our observation tent. Client was brought inside by wheelchair to our emergency area for further evaluation. Client was answering questions, pulse ox read 100%, pulse 106. Client had increased complains of tightness in throat, was coughing. 4:11 pm- 0.3 Epi pen given in right thigh. Lot # OFM534, exp: 9/20222. Call made to 911. Client then lost consciousness, eyeballs were fluttering underneath lids. Sternal rub- did rouse client, but then she became unconscious again. Daughter then reported a history of allergy to MRI dye, Pulse 110, 2 L O2 started. Client remained unresponsive, but was breathing normally. 415- call to Dr to assess whether Benadryl should be given or not- since client was unconscious. 415 shaking/chills began, and daughter reported history of non-epileptic seizures, but none since 2019. 416pm EMS arrived- IV started and seizure #2 witnessed by EMS. Seizure meds given per EMS- client transported to hospital.
41 2021-04-11 tingling I began feeling extreme pain, nausea, fatigue and headache within a few hours of the shot. The join... Read more
I began feeling extreme pain, nausea, fatigue and headache within a few hours of the shot. The joint pain and fatigue increased and has persisted as of Monday (day 5 following first dose) becoming extreme at times. I have severe headache on and off. I threw up 2x a day from Thursday-Sunday. My lips began tingling on and off on Wednesday evening April 7 and that has continued ever since. I have also had tingling in my extremities especially my legs and feet, but also my left hand. Fatigue has not improved and as of today, I began to get worse (onset of chills and fever as of 4/12).
41 2021-04-11 tenderness Severe swelling and pain/tenderness in left arm, armpit, wrist, left side of my neck, left shoulder,... Read more
Severe swelling and pain/tenderness in left arm, armpit, wrist, left side of my neck, left shoulder, left ribcage (front and back), left knee , left ankle. Fatigue. Swelling and fatigue have been decreasing over the past days but are still present.
41 2021-04-12 feeling hot Sore arm near injection site, Achy joints, chills, head feeling hot, intense headache for 5 hours, b... Read more
Sore arm near injection site, Achy joints, chills, head feeling hot, intense headache for 5 hours, blocked right ear
41 2021-04-12 pain in extremity, tingling Really sore arm, slight headache, tiredness and tingling fingers on left arm
41 2021-04-12 pain in extremity An hour or so after the shot my arm started to get sore and I started to feel fatigued. During the e... Read more
An hour or so after the shot my arm started to get sore and I started to feel fatigued. During the evening the arm pain grew worse. The next morning I remained fatigued and ran a low fever. The arm pain was reduced. The low grade fever lasted until around 5 pm. The next day I felt close to back to normal until around 7 pm when fatigue set in again.
41 2021-04-12 pain in extremity 1st shot 3/20/21 and 2nd shot 4/10/21. My period is typically about 5 days and very regular. I sta... Read more
1st shot 3/20/21 and 2nd shot 4/10/21. My period is typically about 5 days and very regular. I started my period on April 1 and today is April 13 and I am still bleeding and I have been extremely bloated. Other side effects that I have been experiencing were more typical arm pain and diarrhea the day after the 2nd shot. Also today I noticed a rash or hives that have started on the arm that I received the shot in.
41 2021-04-12 pain in extremity Sore arm for 36 hours
41 2021-04-12 pain in extremity patient has experienced neck, right arm, and shoulder blade pain ever since received 2 nd dose on 4/... Read more
patient has experienced neck, right arm, and shoulder blade pain ever since received 2 nd dose on 4/8/2021
41 2021-04-12 tingling, numbness From an email received 08 April 2021-"My1st vaccination was on the 20th of March. On the 28th/29th (... Read more
From an email received 08 April 2021-"My1st vaccination was on the 20th of March. On the 28th/29th (I?m not entirely certain which night it began), I woke up in the middle of night experiencing a pins and needles sensation in my lower legs. It was mild enough that I assumed I had just slept in the wrong position. Over the course of the next several nights, the numbness and pins and needles sensation grew progressively worse. I was waking up several times throughout the night as a result and the numbness and tingling has spread to all four limbs (hips to toes, shoulders to fingers). The night of April 1st, the feeling had grown severe enough that I had trouble sleeping and was growing very worried about the symptoms. I didn?t have any symptoms during the day though, and that night the symptoms mostly went away. I still have the tiniest bit of mild tingling in my toes sometimes overnight, but otherwise I?m feeling just fine now."
41 2021-04-12 tingling Within 20 minutes, my body felt like a sandbag with dizziness and my equilibrium was off balance fol... Read more
Within 20 minutes, my body felt like a sandbag with dizziness and my equilibrium was off balance followed by a sense of falling forward. Paramedic took my blood pressure and oxygen. He offered to get me ride to hospital. I declined. I decided to call my doctor, then I started to feel allergic reactions with tingling nose lips and tongue and also back of throat was itchy and scratchy. I felt out of control. Doctor asked me to come to office and get seen. Within an hour, my symptoms worsened. I had a hard time walking and the doctor assessed me. Looked at my throat and listened to my lungs. I was wheezing. I had to take high doses of Benadryl and a steroid. I was told if any symptoms worsen, I have to go to hospital. I had all symptoms for 48 hours before I felt a turnaround and things lessened. I was not able to do much at all and could not go to work. I have continued symptoms with asthma and some allergy reactions that are lingering.
41 2021-04-12 seizure Patient was intially responsive.. After waiting approximately 5 minutes patient informed staff at ph... Read more
Patient was intially responsive.. After waiting approximately 5 minutes patient informed staff at pharmacy that she felt like she was going to have a seizure. Patient moved to floor from chair. Was conscious for about 5 more minutes. Lost consciousness during seizure (approximately 2-3 minutes). Emergency medical personnel was called at that time. Patient regained consciousness and went with EMS to hospital for further testing.
41 2021-04-13 weakness Pfizer-BioNTech COVID-19 Vaccine EUA. Shortly after injection, during the initial 15 minute waitin... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Shortly after injection, during the initial 15 minute waiting period until 5 or 6 hours later, there was a weird taste in my mouth and a tightness in the back of my throat, as though the glands were swollen and constricted my throat making it uncomfortable to swallow. There was no pain. Between a rating of 1 to 10, the discomfort level was about 5. I also felt weakness in my whole body and walking felt strange and lasted for the entire day. The injection site has mild soreness even 24 hours later.
41 2021-04-13 burning sensation Burning hot sensation on tight side of chest/breast
41 2021-04-13 feeling hot My lymph nodes in neck became very painful at 7 am and got worse through the day. I had to leave wor... Read more
My lymph nodes in neck became very painful at 7 am and got worse through the day. I had to leave work bc pain was so severe. I had bad wheezing and a terrible cough. I now three days later still have swollen lymph nodes, low temp, and hot sweats.
41 2021-04-13 numbness numb face and weakness left arm and leg.
41 2021-04-13 migraine, hot flush, pain in extremity *Lips tingled then went completely numb - started 30 minutes post shot and lasted for about 2 hours ... Read more
*Lips tingled then went completely numb - started 30 minutes post shot and lasted for about 2 hours *Burning flush feeling - like "niacin flush" - felt over face, neck and upper body starting about 45 minutes post shot and lasting for about an hour *Severe headache / migraine - started slowly about an hour after shot and built up to migraine at 2 hours post shot. Lasted for almost 2 days and then went away to dull headache on 2nd morning after shot. Took Tylenol starting 8 hours post shot and repeated every 6 to 8 hours. *Brain fog / inability to concentrate - started 3 to 4 hours after shot most severe 6 to 10 hours post shot. Slowly came back with 2nd night of sleep. *Dizziness - started 40 minutes post shot while driving home. Most severe about 2 hours post shot then lessening. Lasted a day and a half and then just went away. *Severe Arm pain - pain in injection site arm for so severe that I couldn't move the arm above chest level or touch it against anything for a day and a half. Woke up on 2nd morning after shot and pain is completely gone.
41 2021-04-13 pain in extremity Felt normal until I was woken up with severe pain in my right wrist. It hurt to touch and to move m... Read more
Felt normal until I was woken up with severe pain in my right wrist. It hurt to touch and to move my fingers or hand at all. I took ibuprofen and was able to fall asleep after an hour. It felt sore the next day but I could use my fingers again. By 4/12 it felt normal. My upperarm also was sore but nothing out of the norm.
41 2021-04-13 tingling, numbness Numbness, tingling arms, shoulders, face, scalp. and developed short of breath.
41 2021-04-13 tingling Pt waited 15 min. Came back after attempting to get into car. RN stated that patient reported left ... Read more
Pt waited 15 min. Came back after attempting to get into car. RN stated that patient reported left arm "electric" feeling down arm briefly after arm, then dissipated. Pt did not report this to an RN. Pt trying to get into car, and reported new onset left let weakness. She came back up to the clinic. RN did neuro check, left leg/foot weakness noted compared to right and possible foot drop also noted. Pt advised to go to ER, initially refused. Then changed mined and then went to ER. According to ER nurse, patient checked in then decided to leave without treatment.
41 2021-04-13 tenderness For 6 days after the shot I experienced a metal taste in my mouth and tenderness in left tonsil with... Read more
For 6 days after the shot I experienced a metal taste in my mouth and tenderness in left tonsil with a sore throat.
41 2021-04-14 weakness, tingling 20 min after receiving vaccine, paresthesia felt in left arm. Spread to left half of face and left l... Read more
20 min after receiving vaccine, paresthesia felt in left arm. Spread to left half of face and left leg 3 days later. Two weeks after that, paresthesia spread to whole body. 3 days post-vaccine, chest pain, abdominal pain, nausea, and weakness began. 9 days post vaccine, abdominal bleeding began. Chest pain resolved in 1 day. Abdominal bleeding resolved in 2 days. Nausea lasted two weeks. Weakness and paresthesia continue 3 weeks post vaccine.
41 2021-04-14 pain in extremity, tenderness Superficial blood clots in both upper legs; each leg had one in the front and one in the back. They ... Read more
Superficial blood clots in both upper legs; each leg had one in the front and one in the back. They were very painful and tender with bruising around the area. The clots could be seen and felt.
41 2021-04-14 tingling, pain in extremity tingling or "pins and needles" in fingers for weeks after the vaccine injection (this is unusual and... Read more
tingling or "pins and needles" in fingers for weeks after the vaccine injection (this is unusual and not something I've had after a vaccine or shot before), still ongoing local soreness (normal for vaccines including flu shots I've had before), this resolved after 48 hours
41 2021-04-14 tingling Itchy eyes; Swelling around eyes; Face tingling AFTER SECOND DOSE ONLY
41 2021-04-14 cold extremities, numbness Dizziness, numbness in face, tongue, and throat feeling tight. 4:00 PM Vital Signs: BP 116/78 HR 4... Read more
Dizziness, numbness in face, tongue, and throat feeling tight. 4:00 PM Vital Signs: BP 116/78 HR 40 O2Sat 97% Skin Signs: Diaphoretic, Other - Cool fingers Circulation: Cap Refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Approx 10 min after vaccine, tongue and lips began to feel slightly numb. Briefly a little dizzy, but that soon passed. Taken to triage at 4:05 PM when numbness increased. 4:15 PM Vital Signs: BP 124/76 HR 66 O2Sat 98% Skin Signs: Cool and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally 4:30 PM Vital Signs: HR 69 O2Sat 96% Skin Signs: Cool and dry 4:40 PM Vital Signs: BP 130/78 HR 67 O2Sat 99% Notes: Decision made to call husband to transport to hospital. Face and tongue feeling worse. 5:00 PM Vital Signs: BP 132/80 HR 62 O2Sat 99% Sent to ER with husband 5:10 PM 04/14/2021: 11:45 AM: Follow up phone call to patient. Doing very well today. Stated she was observed in ER for 1 hour last night. Symptoms gradually subsided over 4 hours. No treatment needed.
41 2021-04-14 cold extremities, pain in extremity, numbness 10 minutes after pain in arm was shooting down to hand and to chest, 10 mins later stomach ache, 30 ... Read more
10 minutes after pain in arm was shooting down to hand and to chest, 10 mins later stomach ache, 30 mins after adminstration tongue, face and throat swelled up. Hand of injection arm went purple, cold and numb. Toes went purple and cold. Had to get taken in ambulance to er hospital due to blood pressure and lack of oxygen. When arrived at hospital broken out in hive,blood pressure went up to 175/104 and severe pain in kidneys, stomach, lower abdominal, legs, arms. Day 2 high blood pressure, fever, hives, stomach, kidney and lower abdominal pain. Painful to urinate and poop.
41 2021-04-15 feeling hot symptoms of dizziness, slight "disorientation", shaky, nausea; notes very sensitive to meds. 1340 BP... Read more
symptoms of dizziness, slight "disorientation", shaky, nausea; notes very sensitive to meds. 1340 BP 158/100, pulse 99, p ox 99%. Able to drink water; no issues swallowing, able to breathe without issue. Still nausea, hot, shaky. Continued monitoring. Denies headache or vision changes. 1350 BP 136/100, pulse 99; complaints of heart racing, hot, comes and goes. No issues breathing. Wanting to go to bathroom; feels stable; accompanied by staff. 1400 BP 140/90, pulse 106. 1410 BP 138/90, pulse 95, p ox 99%. Feeling more herself; still some shakiness. Refused ED evaluation; feels comfortable going home. Brother accompanying; will drive.Aware if symptoms worsen/issues breathing, to seek medical attention; agreed.
41 2021-04-15 flushing, numbness Dizziness, flushing/sweating, numbness fingertips, BP 145/91; HR 75; RR 16, Temp 98.6, 100% RA
41 2021-04-15 migraine, tremor Around 8:00pm I started experience ear fullness and tinnitus (pulsing with my heart beat) in my righ... Read more
Around 8:00pm I started experience ear fullness and tinnitus (pulsing with my heart beat) in my right ear along with a mild headache on that side. At 11:00pm I woke up with one of the worst migraines of my life and I was shaking uncontrollably. Only a mild temperature of 99.2. I took two Extra strength Tylenol and 30 minutes later the shaking subsided by the temperature did not. The headache persisted until 11:00am on Friday. Migraine symptoms included aching and shooting pains on the right side of my head near my temple, neck pain, light and smell sensitivity. I also smelled things that were not there--like the smell of burnt toast and garlic. I regularly get migraines and have seen a neurologist for these, but do not take prescription medication. I had tinnitus in the same ear about 12 years ago, but have not experienced symptoms since.
41 2021-04-15 muscle spasms I do not have a monthly period as I have the mirena IUD. I have not had a period in the last 6 mont... Read more
I do not have a monthly period as I have the mirena IUD. I have not had a period in the last 6 months. I revived the Pfizer COVID 19 vaccine, on March 25, and had cramping and started my cycle on March 27
41 2021-04-15 muscle spasms I tested positive for pregnancy on March 17, 2021. on March 24th I got my first dose of the Pfizer v... Read more
I tested positive for pregnancy on March 17, 2021. on March 24th I got my first dose of the Pfizer vaccine for COVID. On April 4, 2021 I had my first appointment with my OB / GYN. The doctor did an ultrasound and found that everything was fine with the baby. The baby was the right size and had a heartbeat. April 14th I got my second dose of Covid's vaccine. After an hour I started having cramps. Around 1:15 PM I had a bleed (light red). Around 2:00 pm I was seen at the doctor's office. She did a new ultrasound. The doctor said she couldn't find a heartbeat during the ultrasound exam and that I was having a miscarriege
41 2021-04-15 night sweats Chills and severe shivering, night sweats, extremely tired.
41 2021-04-15 pain in extremity, muscle spasms, migraine Six days after my second shot of Pfizer I got a DVT Clot in my left leg behind the knee. Started wit... Read more
Six days after my second shot of Pfizer I got a DVT Clot in my left leg behind the knee. Started with Severe pain felt like a charlie horse in my left calf and foot that would not go away for more than 24 hours. My Blood pressure spiked and i got a migraine from the pain , My left leg and food felt like stone.. The next day I called the nurse from my insurance company and she advised I go in to the hospital. Went to ER got a Ultrasound, blood tests and the ultrasound came back positive for a DVT clot. Treatment is Xarelto and follow up with my primary. Lab Results came back normal.
41 2021-04-15 pain in extremity Developed arm soreness, headache, and right eye swelling with eczema a few hours after 2nd dose. Had... Read more
Developed arm soreness, headache, and right eye swelling with eczema a few hours after 2nd dose. Had whole body aches and chills throughout the night. Woke up with swollen, red, itchy face. Had fatigue and dizziness throughout next day. Side effect subsided within 24 hours. 6 days post 2nd shot, developed face swelling, redness and itch. Woke up the morning of 7 days post 2nd shot with extremely swollen eyes, cheeks and lips that were red and burned. Went to ER and received 3 IV drugs, including Benadryl, took 3d of oral prednisone and also a topical steroid prescribed by dermatologist. Swelling and redness subsided within 48hrs but flared again 14d post 2nd shot. This flare was mild compared to d7, is limited to mild swelling of lips, redness and itch of lips and eyelids and is being treated with topical steroids.
41 2021-04-15 seizure, night sweats, hypersensitivity of all senses, tenderness he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp... Read more
he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp of 100.5. The shivering quickly changed to more of a convulsing and temp got up to 104.7F. When I woke the next morning, temp was back down to 101-102F and most of shakes were subsiding. But I noticed that I had a deep, cutaneous pain reaction from head to toe when I awoke on 3-5-21. I could not brush my hair because my scalp was too tender. I couldn't let anything touch me and put pressure against any part of my body. Then at 3:30 that afternoon, I went to bathroom and had a bowel movement. It was so excruciating that I truly though my colon might have come partially out. I was in too much pain to flush, so I crawled across the house to my bed and laid on my side for an hour, crying. When I was finally able to go back to the bathroom to flush, I was expecting a large BM. It was not. It was about 2" x 1" and soft. There was no blood. It just felt like it tore me up. ****Then at 7:30 PM on 3-5-21 was when things got very serious. I was sitting down watching TV after a light meal. Suddenly, I started noticing discomfort deep in my upper back, between my shoulder blades. Within 5 minutes, it was at its worst....I was have rated it 11/10 pain. The pain was just very deep, behind the spine, about palm sized radius and unrelenting. My first thought was "maybe this is musculoskeletal since I've been in bed a lot because of the pain today." So I looked in my medicine cabinet for what I had and took 5 mg of Oxycodone and 10 mg of Cyclobenzaprine. An hour later, these meds hadn't touched it. I was beginning to really worry about an MI, or aortic dissection or pulmonary embolism (though I had no SOB). Lying flat on my back on a hard surface seemed to provide the only relief (though minimal relief, 9/10 pain). I called another provider who was on call and told her. She said that I could try taking 800 mg of Ibuprofen, but if I wasn't relieved in 1 hour, I needed to call 911 or have someone take me to the ER. I was asleep in an hour. I took it easy the next two days but started feeling back to normal during the days. I continued to sweat throughout the nights and skin pain continued so much that I had to cut some of my hair out. That following Tuesday, the deep upper back pain returned.
41 2021-04-16 flushing 0835 161/110 125 98% RA RR 20 Vaccine 0830 administration by NP who screened patient. Allergy hist... Read more
0835 161/110 125 98% RA RR 20 Vaccine 0830 administration by NP who screened patient. Allergy history, explained monitoring for adverse event to patient. Reaction 0835 feeling flush, throat tightness. First responder called and arrived quickly. NP examined LS clear No cyanosis No signs angioadema 25 mg Benadryl liquid given at 0843 0845 to ED via wheelchair with first responder and security guard
41 2021-04-16 numbness, tingling Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occ... Read more
Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off. Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-04-16 numbness and pain in extremities, inability to speak, migraine Migraines resistant to OTC NSAIDs. I woke up with the migraine on 23 March. Pain phases lasted multi... Read more
Migraines resistant to OTC NSAIDs. I woke up with the migraine on 23 March. Pain phases lasted multiple days, with multiple nausea, visual disturbance, aphasia, and facial neuropathy phases. These have been common for me in the past, but have only rarely occurred the last few years. Migraines would fade after 3-4 days, then come back 1-2 days later for the 3 weeks following the injection.
41 2021-04-16 pain in extremity, muscle spasms Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in bo... Read more
Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in both lungs). Context: After the first vaccine (about a week before my second vaccine), I self diagnosed myself with a calf injury due to extreme pain in my calf that felt like a continuous cramp. The extreme pain lasted until my second shot (about a week). When going for my second shot, I reported a rash with hives on my lower abdomen that had appeared within five hours of my first shot, so they requested I stay a little longer for observation. That night I began having some breathing difficulties, but assumed they were to be expected. The breathing difficulties continued to get worse until my nurse practitioner told me to go directly to the nearest ER (2/16/21), where I was officially diagnosed with multiple bilateral pulmonary embolisms. I was admitted to healthcare facility for 24-48 hours, until an EKG revealed heart abnormalities that caused them to use a physician's transport to move me to another unit. I was discharged from the hospital on 2/2/21 after I stabilized from heparin shots, avoiding more invasive procedures. I have been in ongoing recovery since then, receiving ongoing care from a hematologist and pulmonologist. A little extra context for you - I arrived to the hospital with diabetic ketoacidosis and have an endocrinologist since hospitalization that has diagnosed me with Type 1 Diabetes (previously misdiagnosed as type 2 - I'm now on insulin which is controlling my blood glucose well).
41 2021-04-16 pain in extremity Soreness in arm, back pain and fever of 100.4 as of 5:25 pm in 4-17/21. Extreme fatigue, body aches ... Read more
Soreness in arm, back pain and fever of 100.4 as of 5:25 pm in 4-17/21. Extreme fatigue, body aches and my eyes are feeling dry as well.
41 2021-04-16 pain in extremity Severe whole body muscle aches limiting normal daily activities. Chills. Arm soreness in injection a... Read more
Severe whole body muscle aches limiting normal daily activities. Chills. Arm soreness in injection arm, swollen axillary lymph node in injection arm, swollen bump at injection site.
41 2021-04-16 tenderness Swelling and bruised feeling in arm pit and collar bone. Joints and tender points inflamed. Worse ... Read more
Swelling and bruised feeling in arm pit and collar bone. Joints and tender points inflamed. Worse on the left side of the body. Can not raise left arm up as stiffness and pain in underarm is intense. Expected, but tenderness, swelling, and pain at injection site. Feels like body was ramped up into a flare up (agin worse on the left side - same as injection side). Headaches.
41 2021-04-17 slurring delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were ... Read more
delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were swollen all over; body and face were swollen all over; new onset of widespread bodily pain; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included hypersensitivity to iodine contrast, anaphylactic reaction, hypermobile Ehlers-Danlos Syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) being evaluated for mast cell activation syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, estrogens esterified/ methyltestosterone (ESTROGEN/METHYLTES), and other unspecified medication. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 10Mar2021 at 14:00 the patient experienced a fever up to 102.7, extreme shortness of breath on standing, coughing and wheezing, delirious and slurring, body and face were swollen all over. The patient called the doctor on call at her primary care physicians office and treated the symptoms with diphenhydramine (BENADRYL), paracetamol (TYLENOL) and mast cell stabilizers. The patient had a bad flare of ME/CFS symptoms, in Mar2021, for about 7 days. She also experienced a new onset of widespread bodily pain in Mar2021 which didn't go away until the second vaccination. The patient received the second dose of BNT162B2 (Lot: ER8730) in the left arm on 31Mar2021 and had a better experience. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of delirious, wheezing, fever up to 102.7, shortness of breath, coughing, slurring, body and face were swollen all over was resolved with sequel on Mar2021; pain was resolved on 31Mar2021; bad flare of ME/CFS symptoms for about 7 days was unknown.
41 2021-04-17 facial pain face hurts; Tooth hurts; This is a spontaneous report from a contactable consumer (patient). A 41-... Read more
face hurts; Tooth hurts; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (Lot Number: ER8737; Expiration Date: 31Jul2021) at SINGLE DOSE in Left shoulder for covid-19 immunisation. The patient medical history was not reported. No Prior Vaccinations (within 4 weeks). The patient's concomitant medications were not reported. The only medication she takes is cholesterol pills. She received her first dose of the Pfizer Covid 19 Vaccine this morning and ever since she came home, her tooth hurts and her face hurts on 1Apr2021. She would like to know if teeth and face hurting are side effects from the vaccine. She reported her teeth at the top are hurting, teeth on the bottom are okay. Said its the both sides of mouth on the top that are hurting. The patient reported this is happening off and on. The outcome of Tooth hurts was unknown, of face hurts was recovering. No follow-up attempts possible. No further information expected.
41 2021-04-17 feeling cold, cold sweat At 1555, RRT was called on a 41 y/o F with c/o lightheadedness, dizziness, and ?feeling cold?. Vacci... Read more
At 1555, RRT was called on a 41 y/o F with c/o lightheadedness, dizziness, and ?feeling cold?. Vaccinated at 1543 on the R arm. She states that some of her symptoms she is experiencing may also be because she has a condition called Chiari malformation. She stated feeling hot and then feeling extremely cold is her baseline and feels dizziness with temperature changes. Head-to-toe assessment completed. Client was cool and clammy. Baseline skin color is pale. BP: 108/62, RR: 21, 0/0 pain. Hx of anemia, asthma, emphysema, and scoliosis. Allergies to NSAIDS, bee stings, PCN, and cipro. Took Megace in the AM. Client stated she wanted to lay down on the floor. Nurses laid a drape on the floor and nurses assisted client to lay on the floor. Client stated she felt better doing that. Throughout monitoring period, client?s condition improved. Client did not want ambulance assistance. At the end of monitoring period, client stated she felt better and opted to go home with her husband. Client left vaccination clinic @ 1620 in stable condition, ambulatory, accompanied by her husband. Husband drove client home.
41 2021-04-17 fibromyalgia, migraine a prolonged episode of her fibromyalgia and Sjogren's condition; a prolonged episode of her fibromya... Read more
a prolonged episode of her fibromyalgia and Sjogren's condition; a prolonged episode of her fibromyalgia and Sjogren's condition; right ankle became swollen; a prolonged episode of her fibromyalgia and Sjogren's condition; joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes); migraines; fatigue; multiple naps throughout the day; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 41 Years, at single dose on 17Mar2021 (Lot number EN6207) for COVID-19 immunisation. Medical history included fibromyalgia, Sjogrens syndrome and lactose intolerant. Concomitant medications included gabapentin, ciclosporin (RESTASIS), cevimeline all taken for an unspecified indication and start and stop date were not reported. The patient previously took celecoxib and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes) was at a 5. Usually, her joint was at a 2. Her right ankle became swollen. Usually, her ankles didn't swell. She also had four migraines during this time - she typically had migraines every two to three months. She experienced fatigue which caused me to take multiple naps throughout the day. She experienced multiple days of brain fog, lasting up to 5 days at a time. Typically, she had brain fog for 2-3 days. Basically, the patient felt like she was having a prolonged episode of her fibromyalgia and Sjogren's condition. The symptoms were still persisting. The patient reported above events was non-serious. It was reported that the adverse event result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". And she received treatments for the adverse events including ace bandage for ankles and further monitoring. The patient was not diagnosed with COVID-19 prior to vaccination and she did not test for COVID-19 since the vaccination. Events outcome was not recovered.
41 2021-04-17 numbness Right side of my face went numb; This is a spontaneous report from a contactable consumer (Patient).... Read more
Right side of my face went numb; This is a spontaneous report from a contactable consumer (Patient). A 41-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6206), via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced right side of my face went numb on 11Mar2021 after 28minutes of vaccination. Communication company: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine. The outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.
41 2021-04-17 migraine Rash in 5 minutes then migraines in 30 minutes
41 2021-04-17 pain in extremity, burning sensation Rash developed on Monday after Friday shot. Bad reaction on the top of my right hand, as well as a s... Read more
Rash developed on Monday after Friday shot. Bad reaction on the top of my right hand, as well as a sight rash on my left wrist, top of left hand, bottom lip. By Tuesday right hand was blistered and extremely painful, with blisters. By this morning, skin was peeling and revealing very pink new skin. Painful burning sensation throughout.
41 2021-04-17 tingling Patient reported headache, tingling in her hands and feet, chest pressure, and lightheadedness 25 mi... Read more
Patient reported headache, tingling in her hands and feet, chest pressure, and lightheadedness 25 minutes after receiving her first dose of the Pfizer vaccine. Blood pressure and pulse were was slightly elevated (140/90, 80), and patient was encouraged to lie down. Juice and a snack were provided, and 10 min later reported feeling better. Blood pressure had lowered as well (125/90). Allergy history includes seasonal allergies and Tylenol. No history of anaphylaxis.
41 2021-04-17 throat numbness Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tin... Read more
Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; She felt panicky, because it felt like her throat was "closing"; very odd, uncomfortable feeling; This is a spontaneous report from a non-contactable consumer reported for herself. This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 in left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021, the patient experienced mouth & throat felt numb & tingly. She felt panicky, because it felt like her throat was "closing". It was a very odd, uncomfortable feeling that lasted roughly 1.5-2 hours. It scared her. No treatment received for events. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of events was recovered on unspecified date. No follow-up attempts are needed. No further information is expected.
41 2021-04-18 inability to speak About 5 minutes after Pfizer dose #2, patient complained of inability to move left UE, then had trou... Read more
About 5 minutes after Pfizer dose #2, patient complained of inability to move left UE, then had trouble responding to questions, follow commands, seemed almost aphasic. BP was high, up to 240/140, but HR, O2 sat were normal. After a few minutes, she was able to talk and move left UE, stated that everything had gone black or dark for a bit. She was monitored, sent via ambulance to ED.
41 2021-04-18 weakness, facial paralysis Pfizer-BioNTech COVID-19 Vaccine EUA: patient experienced worsening left-sided facial droop, dizzine... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient experienced worsening left-sided facial droop, dizziness, tongue heaviness, and weakness within minutes after reciving vaccine. Vital signs within normal ranges except for blood pressure 141/06. Patient observed and monitored, diagnosed by neurology with myasthenia flare, and discharged to home ambulating independently and stable.
41 2021-04-18 weakness, tremor Increased heart rate, confusion, shaking/muscle twitch, increased breathing, weakness
41 2021-04-18 burning sensation Received 2nd vaccine on 4/16/21 & developed hives all over with a burning feeling on 4/17/21. Went t... Read more
Received 2nd vaccine on 4/16/21 & developed hives all over with a burning feeling on 4/17/21. Went to ER and received IV Benadryl and Solumedrol. Sent home on oral prednisone. Feels much better today 4/19/21
41 2021-04-18 feeling cold 12 hrs after vaccine had severe chills, very cold, slight fever, aches. Chills subsided and continue... Read more
12 hrs after vaccine had severe chills, very cold, slight fever, aches. Chills subsided and continued with fatigue and overall achy feeling the next day. Symptoms subsided about 24 hrs from onset.
41 2021-04-18 feeling hot I felt fine until I got up in the middle of the night to use the restroom. It was when I tried to ge... Read more
I felt fine until I got up in the middle of the night to use the restroom. It was when I tried to get up from the toilet that I lost consciousness and fell forward. My husband discovered me laying there some time later. Before passing out I felt hot, and my ears were ringing.
41 2021-04-18 numbness, bell's palsy, numbness and pain in extremities Weakness of Right Eye; Numbness in right eye; Feels tugging in the back of her head and symptoms aro... Read more
Weakness of Right Eye; Numbness in right eye; Feels tugging in the back of her head and symptoms around right eye; Weakness in arms and legs; Feels tugging in the back of her head and symptoms around right eye; Neuropathic Symptoms on Right Side of Face; Numbness on Right Side of Mouth; she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her Bell's Palsy, and the corner of mouth started to have numbness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 (at the age of 41-year-old) as single dose for covid-19 immunization. Medical history included facial paralysis from 1998 to an unknown date, Bells palsy at age 18 , ongoing temporomandibular joint syndrome , asthma exercise, depression, pain, hypoaesthesia, Numbness in face in the past (June 2020 tele-visit with neurologist), fatigue, headache, anxiety. Concomitant medications included gabapentin (GABAPENTIN) taken for neurological symptom, hydroxyzine (HYDROXYZINE) taken for anxiety. The patient experienced she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her bell's palsy, and the corner of mouth started to have numbness on 01Mar2021 with, neuropathic symptoms on right side of face on 01Apr2021 with, numbness on right side of mouth on 01Apr2021, weakness of right eye numbness in right eye, feels tugging in the back of her head and symptoms around right eye, weakness in arms and legs, feels tugging in the back of her head and symptoms around right eye. Caller states basically she had Bell's Palsy years ago and was left with cranial nerve damage. She stated she noticed after the first Pfizer vaccine, that in that area of the face that she had Bell's Palsy, she started having neuropathic symptoms. and stated that it started thursday. States it has been there for a couple of days and she still has a little bit of neuropathic symptoms but not as great as when the onset began. The outcome of the events was recovering. Information about batch/lot number has been requested.
41 2021-04-18 tingling, throat numbness, numbness Patient reported at 1213 tingling/numbness in her lips, right side of face and throat with redness a... Read more
Patient reported at 1213 tingling/numbness in her lips, right side of face and throat with redness and mild facial swelling of the right cheek. Pt. stated feeling "a sense of doom." She felt warm to the touch. Denied chest pain or dyspnea. 911 called at 1213. FD station is steps away from our site, so we rang their doorbell and they responded and were on site at 1216 with their 3 BLS supporting the 3 RN's on site mananging the event. Vitals #1: @1214 BP 180/100, P 100, RR 24, O2sat 98%. Vitals #2: @1219 BP 180/120, P 85, RR 22, O2sat 98%. ambulance arrived at 1220. Pt. remains with same and not worsening symptoms. Vitals #3: @1225 BP 150/120, P 98, RR 22, temp 100.1F. Pt. left in ambulance at 1230.
41 2021-04-19 burning sensation Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that... Read more
Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that went up to 102.1 followed by chills and body ache, light headed ness and headache. Rashes occurred 10-12hrs after vaccine and got worse till was treated at a medical clinic and er. Had heavy heart rate of 120+ IV administered with diphenhydramine which is continued even now as slight rashes still exists and prednisone was given on Sunday April 19 2021 at 11:50am Later since rashes still persisted was advised by the urgent clinic to go to ER where hydroxyzine was given
41 2021-04-19 nerve pain Shingles breakout approximately 13 days after receiving vaccination. Rash, nerve pain
41 2021-04-19 cold extremities Major symptoms are plugged/whooshing/ringing/popping ears. Pressure in my head. Dizziness, especial... Read more
Major symptoms are plugged/whooshing/ringing/popping ears. Pressure in my head. Dizziness, especially when I look up after looking down at my phone. My hands and feet get so cold they hurt. I can put my frozen feet by my space heater and they don?t warm up, they just hurt more. Inability to concentrate and foggy brain. During meetings I find myself starting sentences but I can?t finish them, it?s like I stop and wait for my friends/family/coworkers to finish my thoughts. Other symptoms that don?t bother me as much. Constant sinus drainage and occasional sneezing. Dehydration. Insomnia and vivid dreams.
41 2021-04-20 flushing Approximately 10 minutes after immunization she began experiencing waves of light-headedness and a r... Read more
Approximately 10 minutes after immunization she began experiencing waves of light-headedness and a racing heart. No rash, no swelling, no wheezing, no difficulty breathing. She stated that her skin was feeling flushed, intermittently. Dr on site and evaluated her. Initial heart rate was 90/minute, cap refill <2 sec. No wheezing, no retractions. About 10 minutes later she experienced a second wave of light-headedness. Ambulance was called and about 5 minutes later she experienced an episode of vomiting. She was then transported to the local ER.
41 2021-04-20 tingling, numbness Client c/o tingling and numbness of L arm. Client seen by EMT (no v/s taken). Client observed to b... Read more
Client c/o tingling and numbness of L arm. Client seen by EMT (no v/s taken). Client observed to be stable, no distress noted at the moment. Client cleared to go home by EMT.
41 2021-04-21 breast pain, numbness COVID-19 SCREEN: Have you had close contact with a laboratory-confirmed COVID-19 patient within 14 d... Read more
COVID-19 SCREEN: Have you had close contact with a laboratory-confirmed COVID-19 patient within 14 days no Traveling in the last 14 days no Fever? no Body aches? no Cough? no Shortness of Breath/difficulty breathing? no sorethroat? no Loss of taste/smell? no headache? no Nausea no Vomiting no Diarrhea no _______________________________ 41 year old female presents with swelling and soreness to right shoulder, arm, axilla, and breast since Friday evening (3 days ago). She received 2nd dose of Pfizer covid19 vaccine to the right arm on day previous on Thursday at 3:40pm. Friday evening also started with the whole right arm feeling heavy and numbness to the right 2nd finger, fever 101F, fatigue, chills, and brain fogginess. Fever stopped the next day. 3/26/21 was first covid19 vaccine dose also to right arm, did not get any similar symptoms. Taking 200mg ibuprofen every 6 hours, Tylenol 325mg every 4 hours for soreness. Denies SOB, or pain or redness or rash at the injection site or redness at injection site. Denies fever or chills at this time. Deneis nausea, vomitng or diarrhea.
41 2021-04-21 breast pain I am experiencing right breast pain. I received this 2nd dose and the 1st dose in my right arm. T... Read more
I am experiencing right breast pain. I received this 2nd dose and the 1st dose in my right arm. The breast pain begin in the middle of the night following the shot. The pain is about a 2 on the pain scale in is persistent.
41 2021-04-21 feeling cold, pain in extremity 11pm the same day I started getting sever aches and chills. This progressed and a fever also develo... Read more
11pm the same day I started getting sever aches and chills. This progressed and a fever also developed. I rotated tylenol and ibuprofen all day and ran a 102 fever with that. I was so cold my body shivered uncontrollably at times. The next day a developed a small dry cough and felt winded after walking. My heart rate as elevated all day. My normal resting rate is 60 and yesterday it was 75. After about 36 hours of this my fever broke and I have felt better each hour since. I have not felt this sick due to chills and aches in many years. I found it strange that my the cough stopped within a day. Other strange symptoms included pain the same Location of the shot but in the opposite arm and I got the shot on day three of my monthly cycle, it basically stopped that day which is unusual It normally lasts 5 days.
41 2021-04-21 numbness, hot flush, weakness Day of vaccine, approximately 2 hours later, the left-side of my face went numb for approximately 8 ... Read more
Day of vaccine, approximately 2 hours later, the left-side of my face went numb for approximately 8 hours. 6 days later, I experienced chills followed by hot flashes, nausea, dizziness, weakness (needed support to walk), headache and ringing in my ears. The chills, nausea, weakness, etc. came in waves for the next 6 days. The tinnitus and dizziness has stayed.
41 2021-04-21 numbness It was reported to this writer by the nurse that the guest stated that she was experiencing new onse... Read more
It was reported to this writer by the nurse that the guest stated that she was experiencing new onset of numbness to her left arm. No additional symptoms. Guest refused water/juice. Guest left after 15 minutes. No additional report of continuing concerns.
41 2021-04-21 pain in extremity - Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -... Read more
- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -Rapid heartbeat 5-10 minutes after injection, along with dizziness, rapid pulse and nausea that lasted approximately 5 minutes -After than, body aches, nausea, arm pain and tiredness -Nausea, exhaustion, arm pain and body aches for 48 hours following injection -Started monthly period early, 4 days following vaccine, period started heavier than normal (started my period 1 week early which is VERY unusual for me) -Some of my vaccine reactions felt exactly like a condensed and much stronger version of PMS
41 2021-04-21 tingling, speech disorder 41 y/o F w/ PMHx panic d/o presenting with difficulty talking, reporting ?feeling a lump in my throa... Read more
41 y/o F w/ PMHx panic d/o presenting with difficulty talking, reporting ?feeling a lump in my throat,? chest tightness/shortness of breath, hazy vision, and tingling in bilateral arms/hands 10 minutes after her first dose of Pfizer (given at 12:03 PM - symptom onset at 12:13 PM). Reports symptoms started suddenly with chest tightness and hazy vision which then resolved after approximately one minute. Reports symptoms then localized to her throat and she felt like she had to gag. After 2-3 minutes of having difficulty talking, she reports she feels like she can fully talk again. Reports her throat swelling sensation has resolved and only residual symptoms are a ?caffeine rush feeling? and tingling in her hands. She did not have water or breakfast today and endorsed feeling nervous prior to her vaccine today. Only medical hx includes panic d/o (occasional - last panic attack 1.5 yrs ago). Not on daily or prn medications and never has been; no h/o seeing psychiatry or therapy. Reports her current symptoms feel different than other panic attacks. No other chronic conditions or daily meds. Denies h/o serious allergic reaction to any medications (oral, intravenous, injections). Reports feeling dizzy with Excedrin PO 10 yrs ago. Never been given Epinephrine. H/o hay fever with weather changes - does not take medications. Pt denies swelling of the face, itching of the skin, rash, CP, dizziness, extremity weakness, HA, n/v, or abdominal pain.
41 2021-04-21 tingling Tingling in hand
41 2021-04-21 tingling Patient is a 41 yr/o female with a history of anxiety, hypothyroidism, and seasonal allergies, who p... Read more
Patient is a 41 yr/o female with a history of anxiety, hypothyroidism, and seasonal allergies, who presents to the emergency department for evaluation of chest pain. She states that she received her Covid vaccination (Pfizer) yesterday. Roughly 2 hours ago, she developed a tingling sensation along her left upper extremity. She soon then developed midsternal chest pain, that she described as a pressure sensation. Symptoms are improved with taking deep breaths. She then felt lightheaded. She ate a couple of lemon heads, and then her symptoms improved. She has a history of anxiety, and is not sure if her symptoms could be related. She had spoken with a friend on her way home from work, who encouraged her to come to the emergency department to be evaluated. She denies associate shortness of breath, nausea, vomiting, fever, chills, dizziness, back pain, or any other complaints at this time
41 2021-04-21 tingling Fifteen minutes post vaccination client developed tingling in her arm after a dose of Pfizer Covid-1... Read more
Fifteen minutes post vaccination client developed tingling in her arm after a dose of Pfizer Covid-19 vaccine. No other symptoms of allergy developed. Injection was given on her left arm. BP 128/91, p 85. Client was evaluated by on-site EMT. Client left clinic after symptoms subsided and was advised to seek medical care if symptoms return or if new symptoms emerge.
41 2021-04-21 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
41 2021-04-22 cold sweat, feeling hot Patient received the vaccine at around 1:05pm, 10 minutes later the patient developed a dizzy, hot, ... Read more
Patient received the vaccine at around 1:05pm, 10 minutes later the patient developed a dizzy, hot, clammy, tired feeling. Pt did not feel well and paramedics were called. After the paramedics evaluated the patient it was determined that they were going to take her to the emergency room.
41 2021-04-22 feeling hot Muscle,joint pain Skin tenderness Tiny runny nose Run down Low fever 99.4 Feel hot
41 2021-04-22 flushing, numbness After the second shot, I immediately felt flushed in my face and my cheeks were bright pink. 1 week ... Read more
After the second shot, I immediately felt flushed in my face and my cheeks were bright pink. 1 week later, I kept complaining about a spot in my back that was numb. Right along the bra strap area of the mid back. On the 2nd of April, I woke up feeling like I slept wrong. The pain moved up and intensified the next couple of days. It settled in my neck, on the right side. I was unable to move my head to the right, up or down. I have seen my chiropractor, my medical doctor, and I just had an x-ray done. I have been prescribed muscle relaxers, anti inflammatory medicine, and steroids now to move past this pain. 21 day after it began, and 6 trips to the chiropractor, 1 trip to acupuncture, 3 trips to the primary care doctor, and now one to urgent care.
41 2021-04-22 tingling, numbness My fingers started tingling about an hour after the vaccine then my feet started tingling. It subsi... Read more
My fingers started tingling about an hour after the vaccine then my feet started tingling. It subsided about 18 hours after. Now my fingers are tingling intermittently and my toes and feet are now pretty constantly tingling/pins and needles and are going numb often.
41 2021-04-22 tenderness Significant pain and redness at injection site. Arm pit area very sore and tender to touch
41 2021-04-22 trigeminal neuralgia Fever over 102, extreme body aches, body aches and fever has stopped now but I am experiencing a tri... Read more
Fever over 102, extreme body aches, body aches and fever has stopped now but I am experiencing a trigeminal neuralgia flare
41 2021-04-23 breast pain Chills, fever, headache, muscle ache, swollen lymph nodes (deep pain in left breast)
41 2021-04-23 discomfort Tinnitus in left ear Pressure in left ear, left side of face
41 2021-04-23 numbness Ninety minutes after injection, face and lips tingled and went a little numb, lost some feeling. Th... Read more
Ninety minutes after injection, face and lips tingled and went a little numb, lost some feeling. Throat went tight and tongue tingled and lost some taste. Throughout the three weeks since it started it comes and goes in severity but has not stopped. One dose of Benadryl was taken and the symptoms did not go away.
41 2021-04-23 pain in extremity fatigue; muscle sore (arm); muscle sore (arm); This is a spontaneous report from a contactable other... Read more
fatigue; muscle sore (arm); muscle sore (arm); This is a spontaneous report from a contactable other hcp (patient). A 41-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 09Jan2021. It was reported that the patient had only Fatigue and Muscle sore (arm) were the side effects. The patient consider the Pfizer product had a casual effect to the adverse event. Outcome of the events was unknown. Information on lot/Batch number has been requested.
41 2021-04-23 pain in extremity Swelling and red blotchy area around injection site. Very hard knot about 1in in diameter around inj... Read more
Swelling and red blotchy area around injection site. Very hard knot about 1in in diameter around injection site. Significant pain going from arm to neck.
41 2021-04-24 weakness Muscle and joint weakness and pain Diarrhea Stomach cramps Nausea
41 2021-04-24 weakness Started 10 minute after the shot I was nauseous with a headache watery eyes , nose I had an asthma a... Read more
Started 10 minute after the shot I was nauseous with a headache watery eyes , nose I had an asthma attack, the nurse I seen took me to a curtain room and gave me 6 pumps of albuterol my bp was dropping at first and I was extremely weak and I took 2 more puffs and my BP went up now and the nurse wanted me to go to the ER and I got up and almost fell I was so dizzy I was given Benadryl at the hospital and received chest X-rays and was watched over and I was continuing to take Benadryl and albuterol around the clock, I was itchy all over and I?ve had to take my albuterol more often then usual now even though feeling better my heat rate is all over the place and and my period is extremely off as well clotting, tissue passing as the vaccine is now itchy again and swollen and hurting after 2 days as of your symptoms were gone
41 2021-04-24 grand mal seizure Grand mal seizure; This is a spontaneous report from a contactable consumer (patient). A 41-year-old... Read more
Grand mal seizure; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 23Mar2021 at 08:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and Tourette's syndrome from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 on 23Feb2021 at 10:30 A.M. (at the age of 41-years-old), administered in right arm for COVID-19 immunisation. Concomitant medications included duloxetine hydrochloride (CYMBALTA), levothyroxine and birth control pills, all taken for an unspecified indication, start and stop date were not reported. The patient experienced grand mal seizure on 07Apr2021. The patient was hospitalized for grand mal seizure for 2 days. Therapeutic measures were taken as a result of grand mal seizure (anti-seizure medication). The outcome of the event was recovered with sequelae on an unspecified date. Information on the lot/ batch number has been requested.
41 2021-04-24 pain in extremity Sore arm for less than 24 hrs.; Rash on my arms and wrists that I noticed almost 24 hrs after inject... Read more
Sore arm for less than 24 hrs.; Rash on my arms and wrists that I noticed almost 24 hrs after injections; Mildly itchy; Looked like tiny blisters; This is a spontaneous report from a contactable 41-year-old female other health care professional (reported herself). A 41 year old non pregnant Caucasian women received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; lot number: EN6207), at an unknown dosage via unknown route of administration in left arm on 12Mar2021 at 15:45 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines with 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient had no allergies to medications, food, or other products. On 13Mar2021, the patient experienced sore arm for less than 24 hrs, rash on my arms and wrists that I noticed almost 24 hrs after injections, mildly itchy. Looked like tiny blisters. Last 3-4 days. As a corrective treatment for the events the patient received benadryl and applied topical OTC (over the counter) ointment. The outcome of the events was recovered. Additional information has been requested.
41 2021-04-24 restless legs syndrome Fatigue and lightheaded within 3 hours of vaccine, lasted 3 full days. Headache within 12 hours of v... Read more
Fatigue and lightheaded within 3 hours of vaccine, lasted 3 full days. Headache within 12 hours of vaccine, lasted 24 hours. Muscle aches and restless legs within 18 hours of vaccine, lasted 36 hours. Dizziness within 24 hours of vaccine, lasted 72 hours. Mental fog within 3 hours of vaccine, lasted 36 hours.
41 2021-04-25 pain in extremity Joint pain, muscle aches, high fever, swollen lymph node in armpit. All went away within 48 hours ex... Read more
Joint pain, muscle aches, high fever, swollen lymph node in armpit. All went away within 48 hours except for joint pain in fingers and toes that I still have 2 weeks later
41 2021-04-25 pain in extremity Flu-like symptoms (fever, aches, fatigue, chills, sweats, lymph nodes in throat sore), plus arm pain... Read more
Flu-like symptoms (fever, aches, fatigue, chills, sweats, lymph nodes in throat sore), plus arm pain at site of vaccine. Second day began having acute chest and abdominal pain which primary care doctor wanted to see me for. Did EKG which was normal. Pain (including chest and abdominal pain) lasted several days, along with fatigue. 11 days later I still have intermittent pain down my arm all the way to hand on arm that got the shot.
41 2021-04-25 pain in extremity Patient woke up with jaw pain and left arm pain. When this didn't subside, she went to the ER and w... Read more
Patient woke up with jaw pain and left arm pain. When this didn't subside, she went to the ER and was found to have an NSTEMI. cath showed no abnomalitys echo showed inferior/infeobasal hypkinesis differential: takotsubo cariomyopathy, viral myocarditis, vaccine reaction Patient wore a heart monitor for a week which showed no abnormalities. Since this time, she has had occasional chest pains, squeezing sensations and pressure. A return visit to the ER because of continued chest pains showed a normal EKG and negative troponin. She is scheduled for a cardiac MRI tomorrow on 4/27/21. She is currently taking 10mg Amlodipine, 25mg metoprolol, a statin and a baby aspirin. The amlodipine seems to have done the most with respect to helping with her symptoms. She does not smoke. 1 glass of wine per week. She is not overweight. She has low cholesterol and low BP prior to this. Only other medical condition prior to this was occasional migraines (2 per year).
41 2021-04-25 restless legs syndrome, feeling cold, night sweats, pain in extremity I previously had COVID-19 early last August. I had all the symptoms and had a fever around 99-100 fo... Read more
I previously had COVID-19 early last August. I had all the symptoms and had a fever around 99-100 for many days in a row. I also got the coughing towards the end of Covid and then had Covid pneomonia and was hospitalized for 4 days as my body just needed oxygen. I was hoping to take the vaccine so I wouldn't get the full Covid illness again. I took my first dose of the vaccine Wednesday morning, 4/21. I only felt tired Thursday morning, 4/22 however by middle of the afternoon I began to have shivers and was very cold. As the night went I was feeling terrible and had first seen a 104 temp but thought I took it wrong. Later took my temp again and was 102.5. After taking some ibuprofen my temp went down to 99.8. I had terrible leg pain and restless legs and couldn't get comfortable the entire evening, full body was in pain. It was worse then having actual Covid, I've never had my body feel that bad before but very glad it was for a shorter time period. Very sore and stiff, almost as if I couldn't get up to use the restroom. I was sleeping in and out (trying atleast) and woke up with night sweats around 11pm. I do think my fever had finally broke around then. I was in communication that night with my friend who is a nurse and we both hoped I would be better by the next morning. Thankfully I did sleep the rest of the night and only felt very tired and exhausted Friday & Saturday. Friday, it was still hard to get out of bed, alot of soreness but glad the fever was done. Saturday was better just tired and started to feel almost back to normal again on Sunday (5 days post my 1st vaccine dose) just still tired even today on Monday, 4/26.
41 2021-04-25 tremor, feeling cold, numbness At 7:10 am on 4/14/21, I first started shaking uncontrollable because I was so cold w/ chills. Then ... Read more
At 7:10 am on 4/14/21, I first started shaking uncontrollable because I was so cold w/ chills. Then about 7:30 am I started breathing hard. My eye sight went black for a few minutes, I almost passed out. Both hands went numb for a few minutes. Then I got a fever, highest was 102.7. Had fever off and on all day and body aches then by 2 pm the fever was better. Then at 7:30 pm, I started shaking again and my fever spiked to 104.5. I got it down to 103 and it was like for about 3 hours then it broke. Then for about a week, I was very exhausted and had no energy and couldn't like normal, no appetite. It took me a week to get to feeling better.
41 2021-04-26 weakness nausea, diarrhea, weakness, low back pain, headache with fever that started around 5:30pm yesterday ... Read more
nausea, diarrhea, weakness, low back pain, headache with fever that started around 5:30pm yesterday 4/19/21 after her first pfizer vaccine on 4/19/21. Taking ibuprofen and APAP. Reports contracting covid in December and feels similar. advised her to take electrolyte replacement, continue ibup & APAP. BRAT diet. Advised to contact her primary doctor if symptoms worsen. Informed her we will contact her tomorrow to monitor her symptoms. 4/23- Three f/u calls unable to reach.
41 2021-04-26 bell's palsy Bell's palsy, abnormal taste, ear pain, fullness, vertigo
41 2021-04-26 pain in extremity, weakness Swollen lymph nodes above left collarbone and in left side of neck, lethargy, headache, muscle pain.... Read more
Swollen lymph nodes above left collarbone and in left side of neck, lethargy, headache, muscle pain. Started with chills and general lack of energy within 6 hours of shot; lymph node swelling and deeper arm and shoulder pain presented 48 hours after shot and still persist at day 4.
41 2021-04-26 pain in extremity PAIN ON BONES AND JOINTS IN THE ARM THAT 2ND DOSE WAS GIVEN NEARLY A MONTH TO DATE OF THE VACCINE G... Read more
PAIN ON BONES AND JOINTS IN THE ARM THAT 2ND DOSE WAS GIVEN NEARLY A MONTH TO DATE OF THE VACCINE GIVEN PAIN HAS BEEN ONGOING FOR OVER A WEEK
41 2021-04-26 tingling, numbness, coordination abnormal Within the first 10 mins, I had chest tightness but I did not need my inhaler. After 5 hours, I star... Read more
Within the first 10 mins, I had chest tightness but I did not need my inhaler. After 5 hours, I started to develop numbness, weakness, heaviness and tingling in my arms and legs. I also felt dizzy when standing up. I had poor coordination when walking and in order keep my balance, I had to walk very slow. Bending down or getting up too quickly would cause me to lose my balance or feel very dizzy. Objects "feel" heavy and it takes much effort to lift anything over 10 lbs. This has continued since 4/16 with gradual improvement. As of today, I still have numbness and tingling in my arms. Fine motor tasks are very difficult and take lots of effort. Items over 10 lbs still require much effort to lift. I still get dizzy when moving fast or bending down or standing up from a sitting position fast. Walking is still an issue as I need to walk slowly to keep my balance. Walking up or down stairs or inclined surface is somewhat difficult for me to keep my balance.
41 2021-04-26 tremor Within 10 minutes of receiving her vaccine she developed dry mouth, nausea, lightheadedness, shakine... Read more
Within 10 minutes of receiving her vaccine she developed dry mouth, nausea, lightheadedness, shakiness, and then a tightness in her throat associated with "gagging."
41 2021-04-27 weakness, feeling hot asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic react... Read more
asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic reaction; felt itching of her throat; fingertip started turning purple; coughing a lot; hard time breathing; hot feeling around her arms and left side of body; it has been three days since she has been really sick; she is easily tired.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 21Mar2021 around 16:15 (Batch/Lot Number: ER2613) (at the age of 41-year-old) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, ongoing systemic scleroderma, ongoing raynaud's syndrome (6 years ago) and interstitial lung disease (6 years ago). Concomitant medications included amlodipine besilate (NORVASC), at 5mg three times a day, prednisone (MANUFACTURER UNKNOWN) via oral at 5mg once a day; mycophenolate mofetil (CELLCEPT) at 1000 mg twice a day, hydroxychloroquine phosphate (PLAQUENIL) at 200mg twice a day, omeprazole (PROTONIX) at 40mg twice a day, sildenafil citrate (MANUFACTURER UNKNOWN) at 20mg three times a day, atorvastatin (LIPITOR) at 40mg once a day, gabapentin (MANUFACTURER UNKNOWN) at 300mg once a day; all are ongoing and taken for systemic scleroderma. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 21Mar2021, the patient experienced anaphylactic reaction and was rushed into to the emergency room after 25 minutes of receiving the vaccine. The patient stated she called the CDC they recommend not to take vaccine of the second dose. The patient stated now she just called and it has been three days since she has been really sick and they told her to call us because doctor at the emergency room at the hospital and specialist because she has an underlying disease (Scleroderma) and told her to double check if she does not take booster of Pfizer vaccine what is the effect in her body? patient stated they are giving her advice that if she does not take it can she can take the J&J. The patient explained after she was administered the vaccine, she went to the waiting area where they told her she should be held for 30 minutes then in about 15 minutes she started getting a hot feeling around her arms and left side of her body so she took off her sweater thinking that would make her comfortable because she was uncomfortable. The patient stated 25 minutes after sitting there the nurse asked if she was ok, so she went out for fresh air that day it was not hot in the hospital but the temperature was around 60 on Sunday so it was really nice weather and she went outside for a fresh breath of air for 5 minutes, stayed took off mask, and felt relieved. The patient went back inside of the room and felt itching of her throat, 25 minutes receiving the vaccine and it stopped when she received the epi pen. The patient stated she thinks she recovered from because since Sunday she has had different effects. Then coughing started 25 minutes so probably roughly around 4:45pm on 21Mar2021 and stated when they administered epi pen not sure time but probably after an hour was when she was reviving in the ER. The patient experienced fingertip started turning purple and this started 30 to 45 minutes when she was rushed to emergency room and because of everything going on she does not remember when it stopped. The patient stated the doctor gave her a shot of epi pen and hooked her up. They did a lot of things in the emergency room that she does not remember. She only remembers her whole hand was purple and they gave her the epi shot. The doctor asked does she know what he was holding, she responded an epi pen, and the doctor said yes. She confirmed she has never used an epi pen before since she has not had any other allergic life-threatening reaction from a vaccine. The doctor said he was going to administer it right now because she cannot breathe. At this time, she was conscious and had a hard time breathing, but was listening. The doctor administered the shot and the hard time breathing and coughing stopped like 30 seconds after. However, she is still having a hard time to breathe. The patient stated the purple hands probably wore off after an hour but since she has Raynaud's disease it was hard for her to recover from circulation of oxygen in body. The patient had hard time breathing because Tuesday she still felt like asthma attack so around Tuesday still having hard time of breathing and still coughing a lot. The patient stated on Wednesday (on 24Mar2021) coughing was regulated a little bit and every time she was walking, she would cough. The patient commented she was discharged from the hospital Sunday. Later confirmed she was not actually admitted, just in the emergency room. The patient stated after the anaphylaxis reaction she was discharged at 9:30 in the evening and the following day she emailed her specialists and then replied and gave her advice that they could give and that she needed to call CDC vaccine and then they check on her. The patient confirmed she did actually go to her physician's office. On 22Mar2021, the patient felt weak she was lying in her house the whole Monday and lying-in bed week and had no appetite. The patient had an asthmatic reaction on Tuesday (on 23Mar2021), like hard time breathing, and she called her pulmonologist, and it was not like emergency and she knows that because she has an underlying lung disease, so she used nebulizer every 6 hours and also used inhaler albuterol inhaler. The patient had hard time walking and stated on Monday and Tuesday she did not get up from bed only just to go to the bathroom and to clean herself but yesterday she started walking around the house and it was hard for her because she was still coughing but today, she was walking already. The patient stated yesterday she was ok but had a hard time if walking it was hard for her to get up from bed and she can walk but she is easily tired. The patient underwent lab tests and procedures which included CT exam as part of her diagnosis for medical condition on an unspecified date and results are unknown. The patient stated she did not have an exam in the emergency room. Therapeutic measures were taken as a result of events anaphylactic reaction, felt itching of her throat, coughing a lot, fingertip started turning purple, hard time breathing, asthmatic reaction like hard time breathing included Epi Pen, Benadryl, she had an IV and the medicine administered through IV was a steroid combination of Benadryl pepa something, and stated she did not know the spelling, but it was a steroid mix that she received in the emergency room. The patient stated when she was home, on Tuesday, she had taken a nebulizer albuterol every 6 hours. She mentioned she just took Tylenol one time Tuesday night because she felt she was getting a fever. Her temperature was 99, not yet fever, but temperature was 99. The outcome of the events asthmatic reaction like hard time breathing was recovered on 24Mar2021, it has been three days since she has been really sick and she is easily tired was unknown and all other events were recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
41 2021-04-27 bell's palsy, numbness Left side of face swollen and numb. Under the care of a neurologist and attending physical therapy. ... Read more
Left side of face swollen and numb. Under the care of a neurologist and attending physical therapy. Diagnosed with Bells Parsey about 8 days after receiving first dose.
41 2021-04-27 breast pain Have been breastfeeding for 15 months - after 2nd vaccine, developed mastitis in left breast. There ... Read more
Have been breastfeeding for 15 months - after 2nd vaccine, developed mastitis in left breast. There has been both a significant decrease in milk production in left breast and severe pain due to infection / mastitis. Have not had mastitis prior to this and have not had any decrease in milk production in left breast like this before. Received vaccine in left upper arm for both first and second dose (3/23/21 and 4/13/21).
41 2021-04-27 coordination abnormal, limb paralysis, slurring, pain in extremity Reaction within minutes, described as if she was given morphine. Dizziness and slurred speech right... Read more
Reaction within minutes, described as if she was given morphine. Dizziness and slurred speech right away. Both arms started being uncoordinated. Within two hours there was extreme pain in both arms and paralysis and pain on the left side of the body. Slurred speech got worse. Trouble walking. Went to Hospital by about 4:30 PM. Dr decided to try an allergic reaction cocktail, ask hospital for specifics. Saline drip and a cocktail put her to sleep for a few hours. She did need to be put on oxygen for a little while. By about 10:30 she was able to talk more clearly and walk better. They sent us home with instructions to have her take 20 - 50 mg of Benadryl every 6 hours as needed for the next couple of days.
41 2021-04-27 flushing racing heart for 15 minutes, flushing of chest, neck and face, dizzy
41 2021-04-27 migraine A couple of hours later I had fatigue, cough, joint pain, muscle pain, change of appetited, brain fo... Read more
A couple of hours later I had fatigue, cough, joint pain, muscle pain, change of appetited, brain fog & lost of voice. I have not fully recovered from this symptoms. I seen several doctors. On 01/19/2021 I seen my doctor they tested me for covid & told me to rest & go back to work when I felt better. On 02/08/2021 got tested for covid again. On 02/26/2021 I was tested again for covid due to my cough and dry throat. On 03/02/2021, 03/9/2021, 03/15/2021 I was seen by raspatory doctor due to the symptoms that I was having. On 03/25/2021 continued cough anxiety and depression fatigue and pain. On 04/02/2021 I followed up with my pcp for my ongoing issues and she refer me with an ENT. On 04/26/2021 I was seen by ER because of migraines and I don't have a history for migraines. Today on 4/28/2021 I am seeing the ENT for the voice lost.
41 2021-04-27 pain in extremity Besides a sore arm, my armpit area became swollen to the point I could not put my arm at my side wit... Read more
Besides a sore arm, my armpit area became swollen to the point I could not put my arm at my side without intense pain. My armpit swelled to the size of a softball or grapefruit. It lasted for several days. After about 3 days the swelling started to subside. It is now 3 weeks past and there is still minimal swelling.
41 2021-04-27 pain in extremity A couple of hours later I had arm pain, fatigue, body aches & headaches. The symptoms lasted about a... Read more
A couple of hours later I had arm pain, fatigue, body aches & headaches. The symptoms lasted about a week.
41 2021-04-27 pain in extremity DVT of femoral vein of left lower extremity, shortness of breath during exertion, cough, diaphoresis... Read more
DVT of femoral vein of left lower extremity, shortness of breath during exertion, cough, diaphoresis, malaise/fatigue, chest pain, flu-like symptoms, POX 96%, woke up at 3am 4/14/21 short of breath and wheezing with POX 94%, headache, dizziness only when short of breath, left leg pain. Pt treated with Eliquis.
41 2021-04-27 tingling, numbness it started about the 10 minutes after the shot.my lips started swelling up and my tongue started get... Read more
it started about the 10 minutes after the shot.my lips started swelling up and my tongue started getting tingly on the tip. my arm got swollen and was noticeable by the wrist area on the arm the shot was given on. my neck started to swell up on that side. then my cheak started getting numb like tingly feeling. it started coming up towards my face the numbness . they just gave shot of Benadryl. never had a reaction to a vaccine
41 2021-04-27 tingling I started to experience pins and needles and tingling in both of my hands 5 days after my shot. It ... Read more
I started to experience pins and needles and tingling in both of my hands 5 days after my shot. It went away for 2 days and then came back again. When it came back, it was predominantly on the right side of my body. It was no longer just in my hand though; this time it was also in my forearm, calf, and foot. It?s now about 2 weeks later from when I first noticed the symptoms and it seems to be getting better.
41 2021-04-28 bell's palsy Bell's palsy; Left wrist felt like it was jammed, stuck, or sprained; Left wrist felt like it was ja... Read more
Bell's palsy; Left wrist felt like it was jammed, stuck, or sprained; Left wrist felt like it was jammed, stuck, or sprained; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, batch/lot number was not reported), dose 1, via an unspecified route of administration, administered in the left arm, on 30Mar2021 11:00 (at the age of 41-years-old) as single dose for COVID-19 immunization. Medical history included thyroid issues diagnosed maybe 7 years ago. The patient has no concomitant medications. The patient reported that she had the first dose and the injection was given in her left arm about 11:00 AM on 30Mar2021, though there were thousands of people there at her appointment at the vaccine center. Around midnight or 01:00 AM on 08Apr2021, the patient woke up with the left side of her face swollen and numb - which was still swollen and numb. The patient can't move the left side of her face. The patient happened to have her neurologist appointment that day, so she brought it to his attention, and he said it was a mild form of Bell's palsy. The patient reported it has gotten worse, it was messing up her speech, she was slurring her words. The patient had a magnetic resonance imaging (MRI) on 13Apr2021, but she doesn't have the results yet. The patient reported that she will start physical therapy and was scheduled to have her blood work on 15Apr2021. The patient also reported that her left hand felt like around the wrist it was like jammed, stuck, or sprained in Apr2021. The outcome of the event Bell's palsy was not recovered while the outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
41 2021-04-28 cold sweat, numbness, cold extremities feeling of blood moving in arms/legs with cold sensation.; Face numbness.; SOB; Events of low blood ... Read more
feeling of blood moving in arms/legs with cold sensation.; Face numbness.; SOB; Events of low blood sugar (not diabetic); Dizziness; Clammy feet; Very scary; Thyroid was in rage during this event; This is a spontaneous report from a contactable health professional (patient). A 41-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 41-years-old), administered in Arm Left on 08Mar2021 10:00 (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included Hashimoto's. The patient had no known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced Face numbness, Dizziness, Events of low blood sugar (not diabetic), SOB, Clammy feet. Most importantly, feeling of blood moving in arms/legs with cold sensation. The patient was hospitalized for the events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The onset of events was 09Mar2021 07:00. The patient also reported that it was "Very scary" and "Thyroid was in rage during this event" on an unspecified date. Went to ER twice weeks apart. Lasted for 3 weeks. The patient underwent lab tests and procedures which included blood glucose: low on 09Mar2021. No treatment received for the adverse events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation) required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events "Very scary" and "Thyroid was in rage during this event" was unknown while for the rest of the events was recovered with sequelae (Recovered with lasting effects). Not diagnosed with COVID prior vaccination, not COVID tested post vaccination. No other vaccine in four weeks. No other medications in two weeks.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-04-28 flushing Shortly after patient received second dose, she had flushing with redness and hives across chest and... Read more
Shortly after patient received second dose, she had flushing with redness and hives across chest and neck. She also had tachycardia. HR noted to be up to 118 in clinic, O2 sats remained stable, BP 124/90 Redness and hives noted to recede while monitoring. Did not require medications while on site. Patient denies EMS transport to hospital as she has personal epi-pen.
41 2021-04-28 numbness, speech disorder vomting, collapsing, dizzy, couldn't feel hands, speech impaired, small stroke
41 2021-04-28 numbness Nausea, bilateral leg numbness, right arm discomfort
41 2021-04-28 numbness Patient called the pharmacy indicating a minor adverse effect of feeling left side of cheekbone numb... Read more
Patient called the pharmacy indicating a minor adverse effect of feeling left side of cheekbone numbness upward to under eye. This effect happened a little after 30 minutes after receiving vaccine around 4:35p.m. Patient feels as if it is bruised. No swelling detected at the time of report. Patient states left eye has always been weaker than the right eye. Vision is normal. Patient felt the normal side effect of tiredness. Patient felt this was an unusual effect that has not been experienced before. Has been less than 24 hours since incident of report. Patient will be self monitoring and will report back to us with any changes in effects. No other allergic reaction present.
41 2021-04-28 nerve pain Severe headaches for at least 5 days Fatigue persisting for 1 month at least, first week in bed -los... Read more
Severe headaches for at least 5 days Fatigue persisting for 1 month at least, first week in bed -loss of work week on sick leave Muscular pain in body which had reduced over the weeks Pain in nerves-initiated in right side of my body and then became strongest in spinal cord which required me to go to hospital twice-Emergency Area March19, 2021 being released with medication March 20, 2021 ; then again March 21, 2021 in hospital being released with medication by March 22, 2021. Nervousness
41 2021-04-28 pain in extremity Sore arm then next day. Tuesday red hot arm with bump low fever of 99.7. Feeling tired. Thursday no... Read more
Sore arm then next day. Tuesday red hot arm with bump low fever of 99.7. Feeling tired. Thursday now still have fever off and on low grade. Arm is hot am like a sunburn and sore. Tired with headache.
41 2021-04-28 tingling, numbness Pt reports acute swelling, mild pain, and episodic numbness and tingling into her 4th and 5th finger... Read more
Pt reports acute swelling, mild pain, and episodic numbness and tingling into her 4th and 5th fingers.
41 2021-04-28 tenderness pain and tenderness in left underarm
41 2021-04-28 tremor Extreme shaking chills, intense body aches all over pain 10/10, waves of nausea, headache, worst phy... Read more
Extreme shaking chills, intense body aches all over pain 10/10, waves of nausea, headache, worst physical pain in lifetime
41 2021-04-30 weakness, feeling hot Dizziness, nausea, weakness in arms and legs, sluggish, tight throat and chest, itching within 2 hou... Read more
Dizziness, nausea, weakness in arms and legs, sluggish, tight throat and chest, itching within 2 hours of shot. Treated at ER with Epi shot, benadryl and other meds. Most symptoms continued day two with fever in cheeks and neck and high blood pressure. Some dizziness, nausea, weakness on day three and four. Treat with benadryl at home.
41 2021-04-30 weakness 15 hours after 2nd vaccine: Fever, chills, dizziness, lethargy, weakness, muscle ache, headache. Aft... Read more
15 hours after 2nd vaccine: Fever, chills, dizziness, lethargy, weakness, muscle ache, headache. After 20 hours above plus nausea. Most concerning, severe headache felt thru the base of neck, back & top of head, and forehead. 48 hours later still feeling these the severe headache and dizziness.
41 2021-04-30 facial paralysis Facial paralysis; This is a spontaneous report from a contactable consumer (patient). This 41-year-o... Read more
Facial paralysis; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female consumer (patient) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6205) in left arm, on 01Apr2021 at 10 AM, for COVID-19 immunisation. No other vaccine was given in 4 weeks. Medical history included asthma and migraines. The patient did not have COVID prior to vaccination. Known allergies: No. Other medications in two weeks: medications for pain in knees were injected. On an unspecified date the patient experienced facial paralysis. The event required treatment (physical therapy) and had not yet resolved at the time of report. COVID was tested post vaccination, on 05Mar2021: nasal swab sample/molecular was negative.
41 2021-04-30 numbness, tingling Right side jaw pain, onset within hours of injection. Right side facial numbness/tingling, onset 12 ... Read more
Right side jaw pain, onset within hours of injection. Right side facial numbness/tingling, onset 12 hrs after injection.
41 2021-04-30 numbness Severe dizziness , numbness in right arm tightening in chest was diagnosed with vertigo prescribed m... Read more
Severe dizziness , numbness in right arm tightening in chest was diagnosed with vertigo prescribed meclizine 25 mg
41 2021-04-30 migraine didn't feel good; sick; blood pressure went high; smells smoke; pulse change; migraine; This is a sp... Read more
didn't feel good; sick; blood pressure went high; smells smoke; pulse change; migraine; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 on an unspecified date, and 5 minutes after she "didn't feel good". The patient was sick, blood pressure went high, smells smoke, pulse change and migraine up until 36 days later. She was on migraine medicine, and that she lost her job because of this. The patient already went to the hospital four times, and her doctor five times. The patient sought guidance on how to remove the vaccine from her system. The patient considered the events as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested.
41 2021-04-30 migraine migraine; she felt like she had had her third back surgery; throwing up; diarrhea; stomach cramps; b... Read more
migraine; she felt like she had had her third back surgery; throwing up; diarrhea; stomach cramps; blood pressure has been so high/My blood pressure reached 200/198; I lost 30 pounds; I had a stroke; pulse high; in pain; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (lot number: not reported) as single dose for COVID-19 immunisation. Medical history included pain, anxiety, two back surgeries previously, and smoke all the time. Concomitant medications included clonazepam (KLONOPIN); and pain medications for her back and anxiety medications (unspecified). She got her first dose of the Pfizer COVID vaccine 36 days ago (11Mar2021) and within 5 minutes, she had the worst migraine of her life. She has had two back surgeries previously and after the COVID vaccine, she felt like she had had her third back surgery that night (11Mar2021). That night, she was also throwing up, had diarrhea and was having horrible stomach cramps. Since then (Mar2021), her blood pressure had been so high that they were afraid that she was going to have a stroke at any minute. For her migraine, she had been to the hospital 4 times for it and they had given her three doses each time of the migraine cocktail and that hadn't touched her migraine. She went back to the doctor and her blood pressure and her pulse were both still high (2021) and with the migraine she was ready to jump off of the dock because it hurts so bad. She was on 4 medicines to try and combat what this vaccine had done to her. She can no longer function. She needed to know an antidote or something to get this out of her system. She stated that she "is going to die from this". She didn't know what to do. They said she was going to have a stroke. She can't work and no one knows what to do because there were no studies on this because it is so new. She wanted it out of her body. Her life literally has turned into her just lying in bed and moaning in pain. She was in the emergency room (due to migraine), there were 3 people in there who had complained from the Pfizer vaccine (unspecified). She was calling because she got her first shot of COVID vaccine and she had a stroke (unspecified date in 2021) and she was going to die. She needed an antidote to get it out of her system because she been to the hospital 5 times now. She had migraine that is so bad that they gave her 4 doses of Topamax, it didn't touch it, she threw up everything she eats, she lost 30 pounds (2021) & her blood pressure reached 200/198 and she smoked all the time, they said she had stroke. She had bad migraine and nothing helped at all. She had doctor appointment, and nobody can give her answer. Regarding second dose, that was 21 days after, but she was not going to get it (second shot) and they said she was 80 % vaccinated. At hospital, when she was in emergency room (for migraine), where they do lab tests (2021), they were fine. She was not getting better, getting worse (not clarified for all events). Date of hospitalization: the day after she got the vaccine and next was two days ago, 3 different times (further details unknown). She further stated that she was driving to doctor. She lost her life because she can't work, this drug had ruined her life (as reported). The outcome of the event migraine was not recovered. The outcome of other events was unknown. Information about lot and batch number was requested.
41 2021-04-30 pain in extremity bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shou... Read more
bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shoulders, arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 at 15:30 (3:30 PM) (at the age of 41 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, and anxiety. Concomitant medications included bupropion; diphenhydramine hydrochloride (BENADRYL), and unspecified supplements. The patient previously took amoxicillin and experienced allergies. The patient experienced rash, hives, itching, bleeding, and pain in head, shoulders, arm on 14Apr2021 at 17:00 (5:00 pm). The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient is recovering from the events. Information on the lot/batch number has been requested.
41 2021-04-30 pain in extremity The first shot my entire left arm was extremely sore for about 24 hours. Second shot I received my ... Read more
The first shot my entire left arm was extremely sore for about 24 hours. Second shot I received my arm was sore for about three hours and then the following day I I began to get a headache. At the moment it is two days after my injection and I still have a headache. My left side of my chest hurts also.
41 2021-04-30 tingling, burning sensation, numbness arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; ... Read more
arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; This moved to swelling of the tongue; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533 and expiration date not provided), via an unspecified route of administration, in right arm, on 15Apr2021 16:15 (at the age of 41-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included PCOS (polycystic ovarian syndrome), allergies to sulfamethoxazole;trimethoprim (BACTRIM), metoclopramide (REGLAN) and amino acid base in iron infusion. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA, nasal spray). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Mar2021 16:00 (at the age of 41-year-old), at single dose, for COVID-19 immunization. On 16Apr2021 16:30 (reported as "initially within 5 minutes"), patient developed arm numbness and tingling. Physician prescribed diphenhydramine hydrochloride (BENADRYL) and prednisone. Within 30 minutes, began to feel burning in face and face began to tense up. This moved to swelling of the tongue and difficulty swalliwing. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 2 days. The patient underwent lab tests and procedures, which included COVID test (Nasal Swab) was negative on 17Apr2021. Therapeutic measures were taken as a result of events and included treatment with epinephrine, methylprednisolone sodium succinate (SOLU-MEDROL), famotidine (PEPCID) and diphenhydramine hydrochloride (BENADRYL). The outcome of the events was not recovered.
41 2021-04-30 tremor, muscle spasms, hypersensitivity of all senses These symptoms persisted for 34 hours: 103 fever, body aches, muscle cramps, nausea, shaking, skin s... Read more
These symptoms persisted for 34 hours: 103 fever, body aches, muscle cramps, nausea, shaking, skin sensitivity. As of now, I am still experiencing fatigue, soreness, and 99.2 temp.
41 2021-05-01 muscle spasms March 19, two days after my first dose I had a sudden intense low back pain and I had a hard time ge... Read more
March 19, two days after my first dose I had a sudden intense low back pain and I had a hard time getting out of bed unassisted, I also needed support to walk and to even shower. This lasted for about a week and slowly subsided, but pain did not completely go away. I got my second dose on April 7 and by April 8 very early in the morning I had all the expected side effects of fever, chills, vomiting, muscle ache and joint pain. But, my low back pain intensified again and now with cramping and spasm on my thighs and legs. I also used a massager on my thighs and legs only to be left with bruising which never happened before when I used a massager. I did not connect the low back pain and vaccine until after my second dose.
41 2021-05-01 tenderness Subacromial bursitis and soft tissue swelling in upper bicep. Pain in shoulder at injection site rem... Read more
Subacromial bursitis and soft tissue swelling in upper bicep. Pain in shoulder at injection site remained until my visit to urgent care. My shoulder hurt at the injection site, then I began to experience pain when moving my arm at the shoulder. Back pain resolved 48 hours post vaccine but arm pain continued until May 23 thru May 25 when my arm pain progressed and I began to see visual redness and swelling in my upper bicep with warm and tenderness. Started on 10 days on prednisone which NP instructed me to start immediately.
41 2021-05-02 coordination abnormal, severe one side paralysis On April 4 (throughout the day) -- began to show symptoms of feeling abnormal / off-center (beginnin... Read more
On April 4 (throughout the day) -- began to show symptoms of feeling abnormal / off-center (beginning around 10am). by 5pm -- became uncoordinated / unbalanced (couldn't access phone, put on clothes, etc.). Advised by Neurologist to seek ER treatment and directed to local hospital. Initially, diagnosed as showing symptoms of a Stroke. Upon further analysis, hospital determined it was a MS Flare Up. Since April 4 -- patient lost use of left side (hands, legs). Right Side brain also affected. Currently in acute rehab (Since April 17) to regain functionality. As of May 3 -- still unable to walk on her own or use left hand. Still experiencing visual issues. Acute Rehab facility believes recovery may take up to a year. Patient's normal Neurologist was puzzled by diagnosis because the symptoms as well as the duration and acuteness of the episode is inconsistent with her MS condition. Patient was originally diagnosed with MS in 2009 and there have no MS flare-ups since the initial diagnosis. The normal Neurologist noted that the symptoms are inconsistent with her history. Believe it was proper to notify, given the recent vaccination. Can provide full medical records, if helpful
41 2021-05-02 feeling hot Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area; extremities)... Read more
Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area; extremities)Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Feeling warm-Medium.
41 2021-05-02 feeling hot At 9:44 PM patient reported severe nausea and feeling "hot". Her temperature was normal, but her for... Read more
At 9:44 PM patient reported severe nausea and feeling "hot". Her temperature was normal, but her forehead was warm. Her pulse was normal. Her oxygen levels were normal. She looked pale. We asked for medical assistance from Amazon. Four blood pressure readings were taken and all were slightly elevated. Her lips were not swollen, but she reported her lips were tingling and her tongue felt thick.
41 2021-05-02 flushing pt c/o nausea, light headedness, flushed and anxious. Water given, vitals stable. Dc'd from clinic.
41 2021-05-02 tingling, pain in extremity Around 2 o?clock in the afternoon, I was sitting at my kitchen table and the skin over my knee star... Read more
Around 2 o?clock in the afternoon, I was sitting at my kitchen table and the skin over my knee started burning and tingling. I got up and it felt very strange. I pulled up my pant leg to find a golf ball size lump that was warm and burning and tingling just under the skin towards the bottom of my patella. It swelled very quickly then slowly subsided. You could palpate it and feel the fluid. After two nights, the fluid is mostly gone but it is very sore. I am unable to kneel on it and it is bruised. Post shower the skin is mottled with bright red. I looked everywhere for signs of a spider or other insect but but there is no puncture mark. My thigh and calf on the same leg are achy.
41 2021-05-03 weakness, tremor, pain in extremity, involuntary muscle movements The second dose of the vaccine almost 8 hours after it was administered began to give me a lot of he... Read more
The second dose of the vaccine almost 8 hours after it was administered began to give me a lot of headache. After 10 hours of administration, I started vomiting throughout that night until the next morning I vomited 7 times. At 11 hours after administration I began with involuntary movements, to shake a lot. It gave me a fever of 40 degrees. The next day I couldn't get up. Body pain, I got dizzy from just walking, and I couldn't urinate, I had pain in the ovaries and pelvis area. That day that was the next, I continued vomiting and I couldn't get out of bed. I was given a saline solution for dehydration, and I took phenergan 50mg for vomiting. 36 hours later my hips and back and legs ached. At 48 hours I started diarrhea which to this day I continue with them (5 days after the vaccine). After 5 days of the vaccination I continue with diarrhea, I have controlled them with imodium and probiotics, I have a weak body, I get dizzy at times, and I continue with pain in the ovaries like menstruation that at the moment is not supposed to be because I was menstruating just 3 days before the vaccination. My body feels strange, my hips, back and head still hurt, and I continue with stomach pain, nausea and diarrhea. Medications were administered at home.
41 2021-05-03 feeling cold, electric shock sensation, discomfort, tremor, tingling, flushing About 15 mins after vaccine I felt a sudden onset of lightheadedness and feeling as if i would pass ... Read more
About 15 mins after vaccine I felt a sudden onset of lightheadedness and feeling as if i would pass out, told the nurse I was going to throw up. I was given zofran and Dr monitored Vs. I continued to experience waves of dizzyness, nausea, abdominal pain. Shaking followed (I felt so cold), along with frequent need to urinate and urgency to have a BM (loose) for several hours. I was given fluids and monitored. They gave Ativan 0.5mg 2.5 hrs later? I was discharged home at 8:45p.m. by Dr and told not to get the 2nd Vaccine. Symptoms continued and worsened on day 3 with Shortness of breath, chest pain and tingling in my arms that spread to my legs, back and neck. The first week I could barley walk and was seen in the ER 2 times for chest pain, shortness of breath, dizzyness, tingling, heart racing, diarrhea, nausea, muscle weakness, insomnia due to shortness of breath (gasping) with heart racing, & unable to control my body temperature. Given Prednisone 40mg which exasperated symptoms. 1/13/21 In ER and given Benadryl 3 bags of fluids, potassium and sodium. Postural tachycardia was noticed. Referral to Neurologist.High D-dimer at ER on 1/16/21 CT scan performed to rule out blood clot in lungs. Reffered to Cardiologist. Metoprolol and Colchicine was started in Jan by Cardiologist Dr . Weekly visits with Dr for the first couple months. More meds started to decrease inflammation. Furthur referrals to Immunologist, infectious disease, and Rheumotology. At 3 months worsening of tingling in my neck and headaches/burning that felt like shocks and shooting down neck and ears. Neurologist performed 3 view MRI to rule out transverse Myelitis. In ER early April for new onset of Petechiae, CBC labs normal. Immunologist states he felt i experienced an allergic reaction followed by secondary anaphalaxis. He is testing me for Mast cell activation syndrome (not diagnosed yet). Now almost 4 months later still unable to work. Waiting results to rule out POTS. Currently battle daily fatigue, chest pressure/pain, lung SOB, heavyness/pressure, with any exertion. I am limited with daily walking/normal activities. Symptoms that come and go are tingling, nausea, diarrhea, flushing of frequent urination, neck pain, regulating temperature.
41 2021-05-03 feeling hot Pt presented to clinic today for 2nd Pfizer COVID Vaccine. Pt reported HX of allergy to a type of fo... Read more
Pt presented to clinic today for 2nd Pfizer COVID Vaccine. Pt reported HX of allergy to a type of food (unspecified), but reported no adverse reaction to 1st Pfizer covid vaccination. Pfizer administered at 10:20am without incident. At 10:35am (15 minutes post-vaccination) pt. reported dizziness when she stood to leave the clinic. RN instructed pt. to sit down, and provided juice and pretzels. Pt drank 8 oz of juice and ate pretzels, but reported that the dizziness was not subsiding. At 10:50am,pt. stood to walk, but stated that she was still feeling dizzy and she reported feeling hot. Pt denied blurred vision, HA, nausea and SOB. RN offered water and pt drank 8oz. Pt walked with assistance from RN to main clinic for further observation. Pt called husband for ride home, and stayed in observation with RN until 11:25am, when husband arrived. Pt reported that she was still feeling dizzy when she left with husband at 11:30am. RN provided instructions to pt and husband before they left the clinic. RN recommended increased fluid intake, laying down with legs elevated above heart, and to call PCP if symptoms persist. Pt and husband verbalized understanding and agreed to call PCP if symptoms continue. 4:20pm- RN called pt. by phone to f/u and see if symptoms resolved. No one picked up- RN left voicemail.
41 2021-05-03 pain in extremity Teusday, 11:20am shot received Wednesday, 03:00am woke up with left arm soreness. Also severe fatigu... Read more
Teusday, 11:20am shot received Wednesday, 03:00am woke up with left arm soreness. Also severe fatigue, muscle aches, nausea 09:00am fever 101.5 10:00am fever 103 noon nausea from 10:00-5:00pm fever was 103-104. Pt alternated tylenol and advil and used ice packs with little to no effect. Thursday am, fever 102.7. At noon, fever 101 Friday, fever 100-101 all day. Injection site swelled to size of lime. No redness at site. Saturday, Pt felt fairly normal. Injection site still moderately sore
41 2021-05-03 tingling, numbness, bell's palsy Bell's Palsy; Mild tingling in the left arm; swelling on my left cheek; musculature changes in the l... Read more
Bell's Palsy; Mild tingling in the left arm; swelling on my left cheek; musculature changes in the left jaw, left cheek and facial nerve regions of left cheek (described as feeling similar to getting an injection at the dentist to numb your mouth).; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: 03461), via an unspecified route of administration in the left arm on 19Apr2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included loratadine/pseudoephedrine sulfate (CLARITIN- D), fish oil, and a multi-vitamin (unspecified). On 19Apr2021, within 5 minutes of the vaccination, the patient experienced mild tingling in the left arm. On 19Apr2021, the patient experienced a feeling of musculature changes in the left jaw, left cheek, and facial nerve regions of left cheek (feeling similar to getting an injection at the dentist to numb your mouth). The patient was concerned it was Bell's Palsy however only noticed swelling on the left cheek. The symptoms remained the same for 2 hours without worsening, then subsided a little. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of Bell's Palsy, mild tingling in the left arm, "swelling on my left cheek", "musculature changes in the left jaw, left cheek and facial nerve regions of left cheek (described as feeling similar to getting an injection at the dentist to numb your mouth)" was resolving.
41 2021-05-04 burning sensation Patient had an allergic reaction/rash in the upper body: arms, face, shoulders, chest and back. Red ... Read more
Patient had an allergic reaction/rash in the upper body: arms, face, shoulders, chest and back. Red rash appeared 3 days after the vaccine. Patient reported the rash with a burning sensation. Itching and swelling of the skin with hives
41 2021-05-04 feeling jittery Patient received her 1st COVID Pfizer vaccine at 1658 pm. She developed hives around the vaccine si... Read more
Patient received her 1st COVID Pfizer vaccine at 1658 pm. She developed hives around the vaccine site L deltoid and forearm approximately 5 min post injection. She was given po Benadryl 25 mg po x 1. No report of SOB initially. VS at 1710: 169/104 HR 86 Pulse ox : 96 %. Sipping water without difficulty. 1715: VS: 153/104 HR: 87 Pulse ox 96% room air. States feeling like she is short of breath. Benadryl 25 mg IM x 1 at 1715. 1720: States no improvement, c/o difficulty breathing and feels like her throat is closing up and difficulty swallowing water. Epi Autojet 0.3 mg IM given L thigh x 1. 911 called for transport for eval of acute allergic reaction with no prior history. NO HX of any acute reactions to anything in the past, she does not carry an epi pen. Only HX of environmental allergies to dust and mold. She does not take any regular meds. She felt jittery after the epi but began to improve greatly. 1730: VS: 178/94 HR: 102 RR: 20, states breathing is greatly improved, itching less and hives much less. EMS here, report to EMS. 1745 Patient released in care of EMS to go to Hospital. Feeling much better. VS: 162/68 HR 93 Pulse ox 97%. Does not feel SOB any more, she is breathing easier, able to drink water. Hives gone.
41 2021-05-04 pain in extremity Began the evening of vaccination with sore arm, followed by nausea and dizziness. Went to bed hoping... Read more
Began the evening of vaccination with sore arm, followed by nausea and dizziness. Went to bed hoping to sleep it off... woke up at 02:22am on 04/26/2021 with fever and chills and body aches. Was in an out of sleep until 06:30am. Nausea, dizziness, fever, chills, and body aches were present all day. Went from lying in bed to on floor to on couch. Could not remain upright to do anything. Took 3 ibuprofen in early afternoon to try to manage symptoms and started to feel a little better. At 04:00pm the pain was so intense, radiating from my upper back through my head and out my teeth (for lack of a better way to describe it). Took 2 ibuprofen then a third to try to manage the intense pain. Ibuprofen was not helping at all. Laid on the floor for hours to try to manage the pain through breathing. Was alone and did not all anyone (and unsure if I should have). Finally around 07:30pm I was able to get off the floor and move around with the pain. Took additional 2 ibuprofen before bed. Slept decently Awoke still nauseas and dizzy. Both subsided by the evening of 04/27/2021. Back to regular activity levels on 04/29/2021 (lingering exhaustion until then).
41 2021-05-04 pain in extremity 41 yo female chronic smoker with PMHx of Migraine currently in no treatment came in to de ER with se... Read more
41 yo female chronic smoker with PMHx of Migraine currently in no treatment came in to de ER with severe bilateral muscular leg pain. Patient was found with severe CPK elevation ( baseline 47,400) elevated AST (baseline 515) elevated ALT (baseline 141) . Patient denies use of statin or medications, viral hepatitis titer negative and no known other cause of CPK elevation. Naranjo adverse drug reaction probability scale reported as 5 which may be consider as a probable vaccine reaction.
41 2021-05-04 pain in extremity No symptoms for about 12 hours after the vaccine. Then, fatigue, body aches, really strong headache... Read more
No symptoms for about 12 hours after the vaccine. Then, fatigue, body aches, really strong headache for about 18 hours. Relieved from 1 extra strength Tylenol. Arm really sore at injection site. Pain in the other arm similar location to the injection site.
41 2021-05-05 weakness Severe lower abdominal pain and weakness for about 6-7 hours a day after vaccine administration.
41 2021-05-05 feeling hot, weakness within 30 mins I experienced palpitations, within an hour, I vomited. then felt dizzy and nauseous ... Read more
within 30 mins I experienced palpitations, within an hour, I vomited. then felt dizzy and nauseous through out the day. at night I was having chills for 3 days. day 2-4, I had sever body aches, fatigue and generalized weakness, dizziness, nausea, feeling hot all over my body and face but no fever based on thermometer and unable to do adls. day 5, no more body aches but still weak, dizzy, lightheaded with nausea. day 6 till present at day 8, no more weakness but still experiencing dizziness , lightheadedness and nausea intermittently, like a motion sickness. unable to perform prolonged walk without feeling dizzy and unsteady indoors and outdoors.
41 2021-05-05 nerve pain, pain in extremity i have received my 2nd dose of pfizer and in the evening i experienced chills, fever arm left side p... Read more
i have received my 2nd dose of pfizer and in the evening i experienced chills, fever arm left side pain swelling and redness...following on the next day i woke up with subclavian lymph node swollen like a ball on my left side. I also experienced this on the 1 st shot. It was hard to deal with the effect of this i also have pain nerve pain and muscle ache all over my body. treatment included tylenol outcome is not recovered. day 2.
41 2021-05-05 pain in extremity, weakness 1) Sore/weak upper arm started within 2 hours, lasted approx 24 hours 2) Menstruation delayed by app... Read more
1) Sore/weak upper arm started within 2 hours, lasted approx 24 hours 2) Menstruation delayed by approx 7 days (expected same day as shot, started one week later)
41 2021-05-05 pain in extremity, tingling, muscle spasms My adverse symptoms began less than an hour after the injection. It began with tingling feelings in ... Read more
My adverse symptoms began less than an hour after the injection. It began with tingling feelings in my right foot. About a half an hour later I began having pain and cramping in my right foot as well. The cramping seemed to come and go in spurts. It was not constant pain. But it kept coming back in the form of cramps. This would continue into the late evening and early morning. I would have to walk around and up and down stairs to get it to calm down in intensity. It also came back in terms of cramping on the following day. It's now still with me 4 days after the vaccine.But usually only in the mornings and evenings. Today cramping started when I walked a ways towards the store from the parking lot. I'm wondering when it will stop.
41 2021-05-05 pain in extremity Patient requested a work note due to having a low grade fever, right arm soreness and a headache thi... Read more
Patient requested a work note due to having a low grade fever, right arm soreness and a headache this am. Patient informed that she could have a work note and that she could take Tylenol for the pain as needed and as directed.
41 2021-05-06 burning sensation Burning forearm, hands, wrist and on top of foot and near ankles. Burning turned into itchy red splo... Read more
Burning forearm, hands, wrist and on top of foot and near ankles. Burning turned into itchy red splotches. Red Splotches turned into itchy large raised, red bumps/hives. Prescribed Benadryl and Visitral.
41 2021-05-06 feeling hot The injection site pain in my shoulder came on after about 4 hours, just as it did with dose 1. Howe... Read more
The injection site pain in my shoulder came on after about 4 hours, just as it did with dose 1. However, the pain intensified well past the level of pain that I experienced after the 1st dose. It made sleep difficult that night. I got up the next day, with a lot of pain in my shoulder, I felt very tired but attributed that to the fitful sleep the night before. However, by about 8:30am (about 3 hours after getting up), I felt worse. My neck, shoulder and upper back felt like as though they were mistreated with a baseball bat. I felt extremely tired, to the point that all I could do was lay down. My eyes were burning. By about 10am my head felt really hot but I had no fever. I took my temperature about every hour and never had a fever. By noon I felt no improvements and decided to take Tylenol. Within 45 minutes of taking it I felt completely normal and well. By the end of the day, even the pain in the injection site was gone.
41 2021-05-06 hot flush Symptom 1 - joint aches including all of the finger and wrist joints as the worst, but also knees an... Read more
Symptom 1 - joint aches including all of the finger and wrist joints as the worst, but also knees and neck and other joints. Vaccine was Tuesday at noonish, this symptom was apparent by 6 am on Wednesday when I woke up. Stayed bad all day Wednesday and Thursday. Still noticeable on Friday as I submit this report, but improving. Best treatment was electric heat pad, and rest. Symptom 2 - fatigue. Began on Wednesday sometime, and I definitely wasn't productive at work on Wednesday. Slept all day Thursday, still slept without over-sleeping issues on Thursday night. Still fatigued on Friday as I submit this report, but improving. Wednesday my body was not where I expect it to be when I moved, I tried to brush a stick out of my path with my foot 3 times and never connected, I also almost fell down when trying to stand up from the toilet once on Thursday. Thursday I had nausea for the first 2/3 of the day, couldn't eat at first and then only "sick food" easy things to digest. Thursday during the same period of nausea, I also had hot flashes/chills. I missed work all day on Thursday, and was definitely at reduced capacity for Wednesday and Friday (so far). Treatments of choice were lots of sleep on Thursday, plus an electronic heat pad for the joints and especially the fingers on Wednesday evening and night, Thursday and Thursday night, and Friday so far.
41 2021-05-06 migraine After the shot, Patient had some chills, and was completely tired. Within the next day or so, she ha... Read more
After the shot, Patient had some chills, and was completely tired. Within the next day or so, she had a terrible migraine headache, with dizziness . After a hot shower, it was a throbbing migraine headache, with dizziness, and vommitting. A day or so later, it was just a terribile migraine. Then after a hot second shower a few days later May 6, it again was a throbbing migraine headache, with dizziness, and vommitting.
41 2021-05-06 muscle spasms, flushing, pain in extremity, weakness On March 6, 2021 when I received my first injection of the Pfizer Covid vaccine, I immediately began... Read more
On March 6, 2021 when I received my first injection of the Pfizer Covid vaccine, I immediately began to feel sick about 5 minutes afterwards. I had instant dizziness, flush feeling, tired, weak and a little nauseated. When I got home I immediately laid down because I felt like I was going to pass out. I slept the rest of the day. Those exact symptoms lasted from March 6, 2021- March 13th, 2021. They began to dissipate the evening of the 13th. I thought all the symptoms were gone but I began urinating blood on March 18, 2021 and I haven't stopped as of yet. I have had constant kidney paid, leg soreness and cramping, dizziness, low blood pressure, chronic pain in my hands and feet, constant fatigue, intermittent headaches, loss of weight, loss of appetite, pain with urination due to the blood. I had a hysterectomy in 2016 so this is not an issue of a heavy period, I no longer have a uterus.
41 2021-05-06 night sweats 18+ days of full body aches, night sweats, chills, extreme fatigue, intermittent sore throat
41 2021-05-06 pain in extremity Extremely swollen lymph nodes in left armpit, pain in left fingers, low-grade fever
41 2021-05-07 feeling hot DIZZINESS, FEELING HOT/SWEATY, SX RESOLVED, REFUSED TRANSPORT.
41 2021-05-07 muscle spasms Early menstration with severe cramping and dizziness
41 2021-05-07 pain in extremity, muscle spasms, numbness, hot flush Chills/ hot flashes 2 days Metallic taste in mouth 3 weeks Muscle cramps ongoing since 4/14 Muscle ... Read more
Chills/ hot flashes 2 days Metallic taste in mouth 3 weeks Muscle cramps ongoing since 4/14 Muscle burning ongoing since 4/14 Headaches 2 weeks Dizziness ongoing since 4/14 Numbness in left hand ongoing since 4/14 Fatigue ongoing since 4/14 Muscle weakness ongoing since 4/14 Back pain ongoing since 4/14 Pain in left arm / shoulder started last night Unable to sleep. Ongoing since 4/14 Nausea 2 days Pain in calves 1 day Cough 1 week
41 2021-05-07 pain in extremity Arm Soreness; This is a spontaneous report from a contactable consumer (patient herself). A 41-years... Read more
Arm Soreness; This is a spontaneous report from a contactable consumer (patient herself). A 41-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in arm left on 08Apr2021 at 12:30 (at the age of 41-year-old) as single dose for COVID-19 immunization. Medical history included chronic autoimmune hives. No allergies to medications, food, or other products. Concomitant medications included within 2 weeks of vaccination, Azo Cranberry, MVI Vitamins Nos, Menopur, Follistim and Ganirelix. On 08Apr2021 at 18:30, the patient experienced arm soreness. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient not received treatment for the adverse event. since the vaccination, patient not been tested for COVID-19. The outcome of the event was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.
41 2021-05-07 tremor Scratchy itchy throat and shakiness starting at 10 minutes after vaccine; hives on both arms/hands, ... Read more
Scratchy itchy throat and shakiness starting at 10 minutes after vaccine; hives on both arms/hands, face, chest, back, legs starting about 45 minutes after vaccine and continuing past 24 hours despite benedryl.
41 2021-05-08 feeling cold Sharp lower lung pain. Felt like when I had Covid last year (also when had pneumonia). It occurred 5... Read more
Sharp lower lung pain. Felt like when I had Covid last year (also when had pneumonia). It occurred 5x over the course of 8 hours. Other symptoms were expected: aches, chills, sweats, headache, nausea-all lasted 24hrs.
41 2021-05-08 pain in extremity Shingles. Started around a day after injection with severe pain in the right thigh and first rash a... Read more
Shingles. Started around a day after injection with severe pain in the right thigh and first rash appeared 4-5 days later.
41 2021-05-09 migraine Day 2 after the injection I suffered a massive migraine and I started to experience terrible pain un... Read more
Day 2 after the injection I suffered a massive migraine and I started to experience terrible pain under my left arm pit. The pain is still there 5 days later. The doctor advised to report my experience..
41 2021-05-09 pain in extremity The woman administering my vaccine placed it really high into my shoulder instead of the deltiod mus... Read more
The woman administering my vaccine placed it really high into my shoulder instead of the deltiod muscle. Within 30 minutes of receiving the vaccine I had severe shoulder and arm pain, they next day 04/16/21 the pain was so bad that I could not use the arm/ shoulder at all. After 10 days I still had severe pain, minimum range of motion, could not dress myself, do my hair, lift my son etc. On 04/26/21 I saw my family Doctor, he told me these "wasn't much" he could do" and had no clue what SIRVA was. and told me to call the mass Vaccination Site. I spoke on 04/27/21 she spoke to their Dr. at , Dr said that based on where the shot was administered that it is likely what I am feeling is bursitis. That I should not get another covid vaccine and the one I received high in the shoulder ?should? be effective. Advised me to follow up again with Dr, my family Dr. Instead I went to see an Orthopedic Dr. on Thursday 05/06/21 at 9:45 am at . Dr agreed the shot was administered way to high based off of where the mark was still on my arm from the needle and my description of events, thought it was very likely that I have Bursitis based off of my symptoms. Made plans to schedule a steriod injection as soon as some other health issues clear up (diverticulitis)
41 2021-05-10 muscle spasms Severe chills, and high fever at least over a 103.0, but I'm not sure how high it went because I was... Read more
Severe chills, and high fever at least over a 103.0, but I'm not sure how high it went because I was to sick to check. This was followed by intense muscle cramping in my chest due to the high fever. I had migraines several times a week that have last lasted until the 2nd dose (today 5/10/2021). Left arm also swelled to almost double the normal size for about 3 days. Post shot fatigue lasted about a week. I checked with an allergist and they said this was a strong immune response because I had had Covid previously, and not an allergic reaction. They also said that my second dose reaction should be less strong.
41 2021-05-10 pain in extremity Sore arm, insomnia, muscle aches, lethargy
41 2021-05-10 pain in extremity Sore left arm (upper portion); This is a spontaneous report received from a contactable consumer. Th... Read more
Sore left arm (upper portion); This is a spontaneous report received from a contactable consumer. The patient was 41-year-old female consumer. The patient received first dose of BNT162B2 (BNT162B2, Solution for injection, LOT: EL3248) through an unspecified route in left arm as a single dose on 03Mar2021, 09:45 for COVID-19 immunization (age at vaccination: 41-year-old). The patient was not pregnant at the time of vaccination. The medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and patient had not received any other medication within 2 weeks of vaccination. On 03Mar2021, the patient had Sore left arm (upper portion). The outcome of the event was reported as recovering. No follow-up attempts are needed. No further information is expected.
41 2021-05-10 tingling Tingling in mouth and L arm/fingertips. BP 113/78, Pox 99%, P 80. Still had slight tingling in mout... Read more
Tingling in mouth and L arm/fingertips. BP 113/78, Pox 99%, P 80. Still had slight tingling in mouth. Instructed to follow up with physician, ER/Urgent Care. Verbalized understanding
41 2021-05-12 discomfort Site: Swelling at Injection Site-Mild, Additional Details: Patient stated that she has had a small, ... Read more
Site: Swelling at Injection Site-Mild, Additional Details: Patient stated that she has had a small, BB-sized lump in her arm at the injection site since her second vaccination dose, which was a "couple months ago" (administration date given is an estimate as patient did not receive it from our site). She stated it was not painful or uncomfortable.
41 2021-05-12 facial pain ? Facial Pain pressure behind eyes, congestion. Has tried otc meds ? Cough
41 2021-05-12 hot flush, tingling Immediate nausea, hot flashes, odd taste in mouth, headache that worsened with time, feet tingling, ... Read more
Immediate nausea, hot flashes, odd taste in mouth, headache that worsened with time, feet tingling, lips puffy
41 2021-05-13 tingling, numbness Numb tingly fi gers, turn white without known reason. Skin peeling on all fingertips
41 2021-05-14 bell's palsy Received the 2nd vaccine 4/15/21 I had fever, muscle aches, chills, fatigue, headache for 2 days. On... Read more
Received the 2nd vaccine 4/15/21 I had fever, muscle aches, chills, fatigue, headache for 2 days. On 5/9/2021 I had a Bell?s palsy episode never had any issue like this before. I did go to my local er expressed my concerns this was a reaction to the vaccine but that was blown off.
41 2021-05-14 hot flush, weakness 1 shot - By the evening of that day, came home feeling exhausted, headache, took tylenol and slept f... Read more
1 shot - By the evening of that day, came home feeling exhausted, headache, took tylenol and slept for 11 hrs. Next day felt less tired and weak but felt normal again by the following day, 2nd shot - Next day had strong headaches, took 600mg tylenol around the clock for 3-4 days. Symptoms include headaches, motion sickness, exhaustion, difficulty breathing which lasted for 7 days. After 1st shot, I haven't had my period which is now almost 3 months. Since my 1st shot, I've been having hot flashes and vaginal dryness. I was thinking these symptons were due to stress but it doesn't explain vaginal dryness. So my dr ordered menopause blood test. My FSH level is at 54mIU/mL. I just started all these symptons after my 1st vaccine shot and my FSH level is very high already.
41 2021-05-14 pain in extremity Left calf pain started around 4/12; went to Total Access Urgent Care on 4/28 as pain had increased w... Read more
Left calf pain started around 4/12; went to Total Access Urgent Care on 4/28 as pain had increased with minor swelling and Ultrasound showed DVT.; swelling; Ultrasound showed DVT; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: er8733, at age of 41 years old) as single dose for COVID-19 immunisation. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included: Levonorgestrel; Pravastatin. The patient previously received Penicillin, dairy products. Left calf pain started around 12Apr2021; went to Total Access Urgent Care on 28Apr2021 as pain had increased with minor swelling and Ultrasound showed DVT (Deep vein thrombosis) in Apr2021. The adverse event result in Emergency room/department or urgent care. The patient received treatment for the adverse event: On Eliquis blood thinner for 3 months. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the event deep vein thrombosis cannot be excluded, due to a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-05-14 tingling, muscle spasms, numbness I felt dizzy and wanted to vomit so I went quickly to the bathroom. I let myself go because I could ... Read more
I felt dizzy and wanted to vomit so I went quickly to the bathroom. I let myself go because I could not stand on my feet. My hands and face began to tingle and my fingers began to paralyze. I felt like my face also began to paralyze including my tongue. Now I have chills and cramps.
41 2021-05-15 pain in extremity Susbstantial arm pain & fatigue
41 2021-05-15 pain in extremity On Friday night I noticed my arm was extremely sore. I woke up Saturday morning at 530 and the injec... Read more
On Friday night I noticed my arm was extremely sore. I woke up Saturday morning at 530 and the injection site was red and extremely swollen. Around 1130 am I noticed I had swelling and soreness in my left collarbone area. Sunday morning the swelling in my left collarbone area was worse. The injection site is still swollen and red and itching. I have emailed my primary care doctor with pics of the affected sites so see what if anything we should do.
41 2021-05-15 tingling Itching & tingling in face and neck, resolved with OTC Loratadine Flu like symptoms Woke up the next... Read more
Itching & tingling in face and neck, resolved with OTC Loratadine Flu like symptoms Woke up the next morning feeling totally normal
41 2021-05-16 pain in extremity Slight aching pain in upper left arm.
41 2021-05-17 facial pain, numbness patient reported numbness and pain in the left side of her face
41 2021-05-17 tingling, numbness Received 1st Pfizer dose on 4/2/21. On (or about) April 15th (13 days later) I had a sudden sensati... Read more
Received 1st Pfizer dose on 4/2/21. On (or about) April 15th (13 days later) I had a sudden sensation and felt the back of my knees and the bottoms of my feet overcome by a strong numbing sensation as if they had fallen asleep. This persisted for a half a day before suddenly going away. This is not a sensation I've ever experienced prior. I drank a lot of water and took magnesium for fear I was dehydrated. The sensation subsided later that day. Received 2nd dose of Pfizer on 4/21/21. On (or about) May 14th (21 days later) and another episode has started, however this has lasted for several days now persistently. This time a numbing sensation only resides on my left side starting from just above the back of my knee down the back of my calf and into the bottom of my foot. The sensation sometimes feels like a vibrating buzzing sensation, to a tingling/numbness. I also feel a numbness sensation on the bottom of my foot with each step taken. In addition, I have a slight numbness in my left arm that radiates from the shoulder, into the armpit, along the inner elbow, and into the palm of my hand and down to my fingers. My right side is not affected. The arm sensation comes and goes.
41 2021-05-18 feeling hot If this is normal due to her steroid injections and causing an interaction with the vaccine; Sweatin... Read more
If this is normal due to her steroid injections and causing an interaction with the vaccine; Sweating; She has had hot sensations in her back where she had trigger point injection shots/became very warm; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old female patient received bnt162b2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jan2021 12:30 (Batch/Lot Number was EL9264) as 2ND DOSE, single for an unspecified indication. Caller stated she got her second dose today of the vaccine, caller states she got trigger point cortisone shots last week, did not mention it to the people administering the vaccine, states after she got the vaccine, the sites where she got the injections for her trigger points became very warm, she states at one point she began sweating. States she got her second dose of the Covid vaccine today, 28Jan2021 at 12:30PM in her left arm, states the injections for the trigger spots are on the same side as the vaccine in her arm and shoulder, states it feels like her whole back is warm now, states it has improved some since about 30 minutes after the vaccine was administered. Caller clarifies the medication she received last week in her trigger areas in shoulder and back is called Bupivacaine, no further information provided. Medical history included none, Concomitant medication(s) included bupivacaine taken for an unspecified indication, start and stop date were not reported. On 28Jan2021, the patient experienced she has had hot sensations in her back where she had trigger point injection shots/became very warm with outcome of recovering if this is normal due to her steroid injections and causing an interaction with the vaccine, sweating with outcome of unknown. Follow-up (28Jan2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer (patient) reported, Information was added. Follow-up attempts are completed. No further information is expected.
41 2021-05-18 numbness, bell's palsy, facial paralysis Bell'sPalsy, left sided facial droop, inability to move the left forehead, left facial numbness, ina... Read more
Bell'sPalsy, left sided facial droop, inability to move the left forehead, left facial numbness, inability to close the left eye
41 2021-05-18 numbness, tingling, pain in extremity Right wrist swelling; Noticed decrease in gross motor function; Severe neck pain; Numbness, tingling... Read more
Right wrist swelling; Noticed decrease in gross motor function; Severe neck pain; Numbness, tingling, pins and needles in right arm and severe pain 10/10 in hand/same symptoms in left hand; Numbness, tingling, pins and needles in right arm and severe pain 10/10 in hand/same symptoms in left hand; Numbness, tingling, pins and needles in right arm and severe pain 10/10 in hand/same symptoms in left hand; Severe lower back pain 8 to 10/10; Disrupted sleep; Unable to bend over and tie shoes and to stand up straight / Unable to sleep sidelying on either side with neck turned since that resulted in pins and needles in arm and hand; This is a spontaneous report received from a contactable consumer other healthcare professional (The consumer reported for self) A 41-years-old (non pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8733, Expiration date: UNKNOWN), via an unspecified route of administration in Right arm on 03Apr2021 03:45 PM as single for COVID-19 immunisation. Medical history included anaemia, Extremely low ferritin levels, Arthritis of the cervical vertebrae. Known allergies to Kiwi, Tomatoes, nightshades from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. On April 5th to April 11th the patient experienced Severe lower backpain 8 to 10/10 which disrupted sleep and caused me to be unable to bend over and tie shoes and to stand up straight. Resolved with ATC Tylenol and Motrin after 6 days. On April 19th the patient Began noticing severe neck pain with concomitant numbness, tingling, pins and needles in right arm and severe pain 10/10 in hand. Adverse event start date: 19Apr2021. On April 20th the patient noticed the same symptoms in left hand. Unable to sleep side lying on either side with neck turned since that resulted in pins and needles in arm and hand. Pain 8 to 10/10 unrelieved by Tylenol and Motrin. Patient was only able to sleep on back with head in midline position. Patient noticed decrease in gross motor function, was unable to open doors with right hand, unable to make a fist with right hand. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient received Treatment for the adverse events which includes, 6 day course of steroid (Steroid taper 6days and started Neurontin 100mg TI) ordered by PMD resolved neck pain but still have numbness, tingling in both hands with daily continuous pain of 7 to 10 at any time. On April 28th: Right wrist swelling noted after steroid completion. Pain still persisting. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Sars-cov-2 test (COVID test name: PCR Test; Test type: Nasal Swab): Negative on 24Apr2021. Outcome of the event Severe lower back pain 8 to 10/10, Disrupted sleep, unable to bend over and tie shoes and to stand up straight, Severe neck pain had recovered on 11Apr2021; the remaining events were reported as not recovered. ; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-05-18 pain in extremity One week following first vaccine dose, developed joint pain in hands, wrists, elbows, knees, and ank... Read more
One week following first vaccine dose, developed joint pain in hands, wrists, elbows, knees, and ankles. Seen by PCP with no findings, seen by Rheumatologist with no findings. X-rays performed-normal. Bloodwork normal other than elevated autoimmune markers which is roasted to Hashimoto?s Thyroiditis. Join pain has Been continuous and remains as it was when it developed. No prior joint issues noted.
41 2021-05-19 burning sensation, tenderness, pain in extremity 5/12, 5/13 and 5/14 - Arm Pain, specially when trying to lift anything. 5/15, 5/16, 5/17 - noticed s... Read more
5/12, 5/13 and 5/14 - Arm Pain, specially when trying to lift anything. 5/15, 5/16, 5/17 - noticed shortness of breath, very sleepy, throat clearing, heavy post nasal drip. Weird taste in mouth. 5/18 - Neck Pain 5/19 - Felt a small moving ball on top of the left side of my collarbone, closer to my throat, it is painful and tender to the touch. My neck feels in pain, actually more like a burning sensation
41 2021-05-19 hot flush, weakness, pain in extremity Within 10 minutes after getting injection - Hives/rash, swelling, increased heart rate and blood pre... Read more
Within 10 minutes after getting injection - Hives/rash, swelling, increased heart rate and blood pressure; Treated by ems on site with benadryl injection Took 1 benadryl tablet at home - 6pm same evening; Day 1 after - hot flashes/off and on fever with some redness of upper arms neck chest and face - approximately 10 times only lasting a few minutes each time; Day 2 after - muscle aches - all over weakness, odd pressure in back of head in the am lasted for about 20 minutes then moved to side of head and subsided after about 20 minutes Tightness in chest across whole front - felt like lungs were tight - never had trouble breathing or swallowing, but dr heard wheezing on occasion - prescribed albuterol. Redness and warmth/hot flashes a few times again. Went to clinic- explained all symptoms, had evaluation - all vitals/numbers good. Ride it out, side effects have been odd and are lasting longer than 24-48hrs. If not feeling any better by Monday call/get checked again; Day 4 after - slight tightness pressure in upper chest/lungs took 1 puff albuterol, returned after dose wore off. Feeling chills starting in the early afternoon then 1 hot flash. Feeling muscle aches more noticeable in upper legs after am dose of advil wore off; Friday - tiredness, muscle aches, pressure in lungs; Saturday - tiredness, muscle aches, pressure in lungs. Experienced menstrual cramps and spotting. I am on Depo Provera and have not had a cycle or cramps in a number of years. Sunday - pressure in lungs, aches, muscle aches, all morning to mid afternoon. Felt better mid afternoon to evening. At night, 2 hot flashes, pulse up a little; Next few days, continued muscle aches, tiredness, and occasional lung pressure. Overall symptoms lasted approximately 10 days. A month later I still have occasional pressure in my lungs.
41 2021-05-19 numbness, tingling PT REPORTED NUMBNES AND TINGLIN IN HER LEFT HAN. IMMEDIATELY AFTER VACCINATION. SHE RECEIVED VACINE ... Read more
PT REPORTED NUMBNES AND TINGLIN IN HER LEFT HAN. IMMEDIATELY AFTER VACCINATION. SHE RECEIVED VACINE IN HER l ARM. SHE PROCEEDED TO STRETCH HER HAND AND APPLY COLD TO THE AREA AND REPORTED IMPROVEMENT IN SYMPTOMS. PT WAS INSTRUCTED AND THAT SHE COULD LEAVE THE SITE ONCE THE SYMPTOMS IMPROVES AND RESOLVED
41 2021-05-19 pain in extremity, burning sensation, muscle twitching, tremor burn marks on her shoulder where they gave her the shot.; Excruciating/ pain comes on /Mild pain; bl... Read more
burn marks on her shoulder where they gave her the shot.; Excruciating/ pain comes on /Mild pain; blisters are busting and scabbing slowly; shake in her arm; arm twitch; burn mark became blisters on right arm; itching; third degree burns on her arm and blisters/burn marks on her shoulder where they gave her the shot. It was on her right arm; third degree burns on her arm and blisters; bruising, burns, and blisters on her arm; burning feeling; Pain in arm; This is a spontaneous report from a Pfizer sponsored marketing program. A contactable consumer(patient) reported that a 41-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 03May2021 14:00 (Batch/Lot Number: EW0164) as 1ST DOSE, SINGLE for covid-19 immunization, at Age at Time of Vaccination of 41 years old. The patient concomitant medications and medical history was not reported. The patient experienced third degree burns on her arm and blisters/burn marks on her shoulder where they gave her the shot. it was on her right arm on 04May2021, third degree burns on her arm and blisters on 04May2021, bruising, burns, and blisters on her arm on 04May2021, burning feeling on 04May2021, itching on 06May2021, pain in arm on May2021, burn marks on her shoulder where they gave her the shot on an unspecified date, blisters are busting and scabbing slowly on an unspecified date, shake in her arm on an unspecified date, arm twitch on an unspecified date, burn mark became blisters on right arm on an unspecified date, all events with outcome of unknown. Additional information reported: Caller had her first dose of Pfizer Covid-19 Vaccine on Monday. On Tuesday, she to go to the Emergency Room. She had third degree burns on her arm and blisters as well. Consumer reporting on self. Caller clarified that her arm looked like third degree burns. She was told her body rejected the vaccine and that was what caused bruising, burns, and blisters on her arm. She awoke Tuesday morning at 0400 experiencing a burning feeling. That woke her up, and she looked in the mirror and saw burn marks on her shoulder where they gave her the shot. It was on her right arm. She did not know what to do. She applied Vaseline, Neosporin, cold water, it continued to hurt so bad the burning sensation. Cold water soother it up a bit but it was burning so bad. She wrapped it up at 0730, she went to the hospital at 0800, and at 0940, as she was looking at her phone in the waiting room, it was burning real bad. She uncovered the bandages and saw a lot blisters. The Emergency room said her reaction was caused by her body rejecting the vaccine. It had nothing to do with what she did or what she put on her body. Vaseline (expiry date: unknown; UPC: 305212345001; Product strength and count size dispensed: 13 ounces, unknown strength; LOT number on tube unknown; Available to be returned: N; Package sealed and intact: Y). Neosporin (EXPIRY: Jun2018; Number near the phone number: 30028394; LOT: 2086LZ; Product strength and count size: unknown strength, 0.5 ounce tube; Product available to be returned: N, no packaging ; Product Sealed: Y). Caller added she was taking the thing off her arm, it hurts. Cold wrap was the only thing soothing it. Caller added her arm looked like a big old long burn mark and the burn mark turned into blisters. The blisters are busting and scabbing slowly, but surely. Caller heard from people it was healing because it was itching real bad. She has 7 blisters on her arm. It was not burning, and she was glad for that because it was so excruciating. Now it was itching, it was healing. It was itching really bad, but is still with blisters and it looks nasty. At 0500 this morning it was itching so bad, she though about going back to the Emergency Room. She does not want to go back to the Emergency Room and stayed home and tried remedies to stop the pain and itching with cold rags that are soothing it a bit. She was getting a shake in her arm where it was making her arm twitch because it was itching so bad. She was provided antibiotics and Motrin. When that wears off every 8 hours, the pain comes on and itching get worse. Caller was taking Cleocin. Then clarifies it also states clindamycin hydrochloride, 150 mg, 3 capsules by mouth every 8 hours for 7 days. Product dispensed in two prescription bottles. 63 tablets in first bottle. 12 tablets in second bottle (Expiry: May2022; She reads Microlab: 42571-0251-01 from the bottle; available to send back: N; Received in sealed package: Y). Motrin: take as needed for mild pain every 8 hours (Product strength and count size dispensed: 800 mg tablet by mouth; 15 tablets dispensed; EXPIRY: 4May2022; She reads Timecap: 49483-0604-50 from the bottle; Available to be returned: N; sealed in package: Y). She stayed up until 0400, then at 0500, it was not burning, but itching real bad. She can not scratch it. Then the pain comes if her medicine wears down. She uses cold rags in order not to scratch around the area because then it causes pain if she scratches. That is how it wound up busting one of the blisters and she was not paying attention and scratched and it busted the blister and it burns and itches so bad. When she takes Motrin that was when the burning stops. Lot number could be EW0164 or EWO164. That did not stop, and she did not want to leave the Emergency Room until it stopped. The Motrin helped out a lot. The event Burns third degree considered medically significant. The events require a visit to Emergency Room. No Prior Vaccinations (within 4 weeks). Information on Lot/Batch number was available. Additional information has been requested.
41 2021-05-20 pain in extremity Started menstrual period early with severe cramps unable to be managed with ibuprofen (rarely have s... Read more
Started menstrual period early with severe cramps unable to be managed with ibuprofen (rarely have severe cramps and usually easily managed with ibuprofen). I also had severe low back and pelvic pain that moved down my legs for 2 days. Bleeding is heavier than usual.
41 2021-05-20 speech disorder, night sweats, pain in extremity, burning sensation, hot flush headache with visual sensitivity, headache, hard to hear for a second, speech was impaired for a sec... Read more
headache with visual sensitivity, headache, hard to hear for a second, speech was impaired for a second, difficult to find words for a second, felts as if she had a fever and kept coming in flashes, pain went down leg, but then quickly went away, index knuckle on left hand felt burning, but went away,2nd day- tiredness, hot flashes, thirsty, 3rd day sleep disturbances, night sweats on each day since vaccine, throat dry on second day, 3rd day throaty dry, lymph nodes swelling, tired, this morning pain in right axillary area, neck still sore, dizziness this afternoon, abdominal upset this morning, hot flashes today
41 2021-05-21 discomfort Extreme fatigue, headache, slightly felt strangled on and off, body aches, lymph nodes hurt, body fe... Read more
Extreme fatigue, headache, slightly felt strangled on and off, body aches, lymph nodes hurt, body felt heavy, foggy brain(felt slightly drugged on and off ), injection site felt stabbed. Started 4 hours after shot on Thursday evening and lasted until Saturday morning. Also Smelled chlorine in my nose in the beginning.
41 2021-05-21 numbness, mild one side paralysis, discomfort, flushing Flushed, Fever, Headache, Nausea, Blurred Vision, Everything moving very fast when sitting still, Di... Read more
Flushed, Fever, Headache, Nausea, Blurred Vision, Everything moving very fast when sitting still, Dizziness, Feeling like weights are on body, Tired, Ringing in ears, loss of hearing, Numbness and weakness on right side of body, Extreme Confusion, Sensitive to sounds and lights, Elevated blood pressure and elevated pulse, Elevated glucose levels
41 2021-05-22 facial pain - Fever 99 to 100.5 - Severe pain in the: back bone, back to front ribs, shoulders to back head area... Read more
- Fever 99 to 100.5 - Severe pain in the: back bone, back to front ribs, shoulders to back head area to all the way coming to the forehead, cheeks, jaw. - Full body aches - Extremely tired - Dizzy but for short amount of time - Nausea - Started sweating on 05-23
41 2021-05-22 feeling hot Developed a blood clot. Symptoms presented by 03/05/21 (palpable bump behind left knee). By 03./07... Read more
Developed a blood clot. Symptoms presented by 03/05/21 (palpable bump behind left knee). By 03./07/21, the area was red and hot to touch with a palpable cord extending in both directions from the original bump. Blood clot diagnosed on 03/09/21. Xarelto prescribed on 04/23/21 (10 mg once daily). Symptoms persist as of today (05/23/21).
41 2021-05-22 numbness and pain in extremities, pain in extremity, tingling, flushing 3:30pm. I experienced bilateral wrists -hands tingling. Asked Charge Nurse if she had anyone experie... Read more
3:30pm. I experienced bilateral wrists -hands tingling. Asked Charge Nurse if she had anyone experience this after the vaccine and she said? yes and these often accompany BP changes.? She sat me down and assessed my BP. R arm measures 112/45 L arm 120/50. Felt flushed and red hot on Right side. Sent me to UCC for eval. Tingling went up to elbows bilaterally. ((My normal BP for last 20 years is 100/60, HR around 70-74pbm.))4:30pm I felt extreme fatigue/exhaustion, dizzy, and thought I was going to pass out. I laid down under blankets. Was fearful of going to sleep as I thought I may not wake up again/die. BP 129/86. Told by RN they were going to do full work-up including assess for hypokalemia and likely send me to ER. I found research which showed this was a reaction to Covid vaccine others experienced and to assess IGG/IGM. MD thought it was a good idea but unsure if insurance would pay for it. Facility did nothing and ordered no bloodwork. Mom came to pick me up as I was unable to drive. At 7:30pm I left. Was upset at lack of quality care. No other Urgent care centers open.8:00pm Took Benadryl for likely vaccine reaction. Experiencing tingling tongue, jaw felt it was not moving correctly/unable to say some words while reading to my son at night. BP still high9:33pm: 109/79, 85bpm.9:57pm: 99/84, 86bpm.11:30pm: 116/76, 85bpm.11:45: 107/73, 84bpm. Slept Sat 2/20. Arms tingling, but mostly Okeson 2/21: 12:00pm Sitting and resting. I felt my heart rate raise and checked. It was 96bpm. I felt dizzy and uneasy, my son was asking me why I was so quiet. Had mom pick me up and take me to ER. BP was high again. Told by MD that she has seen these HR and neuropathy reactions in others after the Covid vaccine. Stated I was indeed having a reaction to the vaccine. Apologized for poor medical care from other MD. Said hands were tied from insurance and could not order IGG/IGM. Instructed me to continue Benadryl or non-drowsy equivalent. Wed 2/24 11am: unable to ascend stairs at work. Needed to rest arms on table in order to stabilize myself and catch breath and converse with staff. Arms painful and tingling. Sat and checked BP 129/76, 93bpm. Asked the plastic surgeon I was working with about my heart issue, and he said it may be anxiety. I do not feel that? s accurate. 3/6/21 woke from racing heart 91bpm;3/10/21:12:38: bilateral arm and leg tingling and pain. Hard to walk upstairs. Head felt like it was going to explode from internal pressure. Rested. L side: BP 122/63, 45bpm. R side 122/78, 80bpm.3/10/21:5pm. Driving with my son. My face felt red hot and as if it was buzzing/tingling. Checked HR was very elevated at 140bpm. 20 mins later check, and it was 115bpm. Worried I was going to have a stroke, afraid of driving especially with my son in car.3/12/21: Acupuncture for palpitations and neuropathy. She worked on heart meridian.3/20/21; Dr visit.; She runs the post-Covid long-hauler research team. Went to assess for vaccine reaction for continued palpitations and neuropathy post vaccine. Asked her about my surgeon? s (employer) idea of anxiety and she said that was a? lazy? diagnosis and she need to see proof of what is going on. Elevated BP 109/74; Ordered Echocardiogram, bloodwork, and 14-day holter monitor. Mar 29, 2021 03:22 p.m. EDT; Bloodwork shows potassium is low:3.4 mEq/L (Low)Reference Range:3.5 mEq/L - 5.1 mEq/L; Dr suggested adding potassium rich foods. I added banana and pineapple to diet. Rechecked Potassium on May 17, 2021 05:06 p.m. EDT;3.9 me/L; Reference Range:3.5 mEq./L - 5.1 me/L; For 14 day monitor I felt my HR raise often as well as experience skipped beats time to time. I recorded these episodes by pressing button on machine.5/3/21: 9:16am; Heart racing 91bpm;5/5/21;11:56pm heart racing 82bpm;5/16/21; Skipped heartbeat (felt very strong) during normal routine day;5/17/21; BP elevated at office. Echo was normal, referred me to Cardiologist for continued palpitations. BP 116/73 (has remained high every time I checked for the last 3 months).84bpm ;5/19/21; Started gui pi tang. No palpitations for two days.;5/20/21; Cardiologist office. ; She was the Cardiologist for the Covid team; She stated my 14-day holter monitor showed elevated HR at 130-140bpm when I was pressing assess for change. No palpitations for 3 days while taking it 3-4 times per day.5/23/21:1:30am woke with racing heart and unease. Worried about having a stroke or other cardiac episode.;4:00am; Took gui pi tang;4:30am; HR 74bpmthe button to record an event. These happened at rest throughout the day, nearly every day. Asked if I was active or stressed at these moments - no, all were at rest with no stress. Said it was? concerning, not life threatening, but abnormal.? Asked if anyone in my family had passed suddenly from heart attack (no). Echocardiogram was negative. EKG showed normal sinus rhythm. She ordered an MRI of heart to assess for myocarditis after vaccine. Awaiting appt. BP systolic remains slightly elevated but diastolic has returned to normal on Left side. BP Left side 110/61, Right side 110/71;5/22/20: Stopped gui pi tang herbs to
41 2021-05-23 difficulty speaking Reported throat feeling "funny" and "hoarse" approximately five to six minutes post vac. Observed p... Read more
Reported throat feeling "funny" and "hoarse" approximately five to six minutes post vac. Observed pt x 51 minutes. No SOB, tachycardia, tachypnea, wheezing, hives, cyanosis observed. Vitals WNL x 2. BP 118/80, Resp 16-18, Pulse 80-88. A/O x3. Over the 51 minutes feeling in throat improved w/o intervention. Left w/o assistance and under no duress.
41 2021-05-23 numbness Severe back pain, followed by numbness in left leg and foot
41 2021-05-23 night sweats Morning after woke up with body aches, extremely sore neck, shoulder and back on the side of the inj... Read more
Morning after woke up with body aches, extremely sore neck, shoulder and back on the side of the injection and injection site. An overall unwell feeling. Tiredness. Night sweats and body chills. Also, swollen lymph glands and tenderness under my right arm pit about the size of half a tennis ball. It is now 05/24 and I don't have the unwell feeling, but still soreness in neck and shoulder and swollen, tender lymph glands under right arm pit.
41 2021-05-23 pain in extremity Chest pain 05/23/2021, 1 hour duration Arm pain, 05/23-05/24/2021 (not yet resolved) Aches/chills/he... Read more
Chest pain 05/23/2021, 1 hour duration Arm pain, 05/23-05/24/2021 (not yet resolved) Aches/chills/headache 05/24/2021 (not yet resolved)
41 2021-05-23 tingling, weakness, pain in extremity Legs covered in purple and blue splotches 48 hours after vaccine, leg and knee pain, weakness and ti... Read more
Legs covered in purple and blue splotches 48 hours after vaccine, leg and knee pain, weakness and tingling.
41 2021-05-23 tingling, nerve pain, numbness Approximately 3 hours after vaccine, I began to have tingling on my upper lip (area where I typicall... Read more
Approximately 3 hours after vaccine, I began to have tingling on my upper lip (area where I typically get a cold sore). Tingling continued to spread to the left side of my face, including my eyebrow, eye and temple area of my head. Tingling has persisted to both of my arms, hands, legs and feet. It comes and goes, and has continued through-out the day. Itching has now developed on my arms, right breast (nipple area) and feet. I have a general "internal" itch that I can't seem to scratch on my arms, legs and feet. On Saturday 5/22, Sunday 5/23 and Monday 5/24 I have also experienced strong nerve pain in my left eye and the lower right side of my head. The pain is sudden, strong but goes away fairly quickly. My left large tie also has developed a numbness, started off with a lot of tingling in that toe. My head generally has a fullness feeling, specifically my ears have a throbbing sensation that I also equate to a similar feeling when my cold sores are active. There is a dull ache behind my ears and the lower back of my head. I developed a headache starting on 5/20 (over the counter meds helped with that) Pain at injection site lasted for 3 days, but was manageable and did not interfere with daily activities. I have not had a cold sore develop as my dr told me to take Valtrex, I have taken one pill of that on 5/24. I also have taken Tylenol on 5/20, 5/21, 5/22 - 500mg 2 times a day.
41 2021-05-23 tingling, tremor, feeling hot Patient reported dizziness, lightheadedness, ascending warmth/tingling, tunnel vision, and that she ... Read more
Patient reported dizziness, lightheadedness, ascending warmth/tingling, tunnel vision, and that she "couldn't feel her hands" shortly after receiving her vaccine. She was highly anxious and stated "I never should have done this". On arrival to med obvs, her hands were in a contracted position and her arms/legs were shaking. Patient repeatedly asked if she was going to be paralyzed. The patient began to feel better after several deep, relaxed breaths. Patient was given water, apple juice, and crackers. Pt requested to use the restroom around 11:10. She was transferred there via wheelchair where she was able to urinate, and reported feeling better after doing so. On discharge, patient reported slight light headedness and "off" feeling, but was otherwise better. Vitals as follows: 10:50- BP 151/84, HR 144, RR 22, O2 97 10:52- BP 146/78, HR 144, RR 22, O2 97 11:00- BP 148/85, HR 125, RR 20, O2 100 11:07- BP 139/78, HR 116, RR 20, O2 100 11:26 (sitting)- BP 135/70, HR 104, RR 18, O2 100 11:36 (sitting)- BP 128/73, HR 98, RR 18, O2 100
41 2021-05-23 tenderness Approximately 24 hours after receiving the vaccination, I rapidly developed pain and tenderness on t... Read more
Approximately 24 hours after receiving the vaccination, I rapidly developed pain and tenderness on the anterior side of my left armpit. This spread to the posterior side as well later that evening. The area is very tender to the touch and feels bruised. Without any external pressure applied, there remains a near constant ache/pain, at times a 6 on a pain scale of 1-10. Ibuprofen does provide some relief, but not complete. The pain continues at time of reporting, some 68 hours post vaccination.
41 2021-05-24 numbness After my first Pfizer vaccine it had facial numbness for about 30 minutes or so.; This is a spontane... Read more
After my first Pfizer vaccine it had facial numbness for about 30 minutes or so.; This is a spontaneous report from a contactable Other Health Professional (patient). A 41 -year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, lot number EL8982 and expiration date 29Jan2021) via unspecified route on Left arm on 29Jan2021 at single dose for covid-19 immunization. Medical history was not reported. The patient's concomitant medications included Hormone therapy medication prescribed. Historical vac-cine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: Ek9231), via an unspecified route of administration in the on Left arm on 07Jan2021 at 02:00 PM at un-known time as a single dose for COVID-19 immunization. The patient did not have allergies to medica-tions, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 07Jan2021 at 02:30 PM, the patient after her first Pfizer vaccine it had facial numbness for about 30 minutes or so. The patient did not receive any treatment for the adverse events. The seriousness of the event was non-serious. The outcome of the events was recovered. Follow-up attempts are completed. No further information is expected.
41 2021-05-24 numbness I noticed with my first shot the tip of my right hand pointer finger was numb for a couple of days ... Read more
I noticed with my first shot the tip of my right hand pointer finger was numb for a couple of days then it went away. Second shot three weeks later my right foot the top tight above the toes to my ankle was numb and I felt like I had hit a funny bone on my right ankle. It feels better there already but still numb above my toes.
41 2021-05-24 pain in extremity Fever, Nausea, Body Aches, Chills, Headache, Severe Arm pain
41 2021-05-24 tingling Patient had paresthesia and elbow pain.
41 2021-05-24 tremor, flushing Pt experienced chills/flushing, chills/shaking, dizziness. BP 141/91, HR 102, T 98.4. 10 min later ... Read more
Pt experienced chills/flushing, chills/shaking, dizziness. BP 141/91, HR 102, T 98.4. 10 min later BP 120/80. Pt has hx of panic attacks/anxiety. Pt was very nervous prior to getting this vaccine. Pt has had similar rxn before. Pt was stable & released from vaccination site 1hr after vaccination
41 2021-05-25 weakness High fever - normally 97.6^F, fever 103.3^F; severe headache; lethargic to the point of severe exhau... Read more
High fever - normally 97.6^F, fever 103.3^F; severe headache; lethargic to the point of severe exhaustion - no energy to walk more than 5 steps; central, focal chest pain/pressure at base of the heart/lower sternum that lasted approximately 20hrs, associated mild wheezing/SOB for the last 10 hrs or so of that window. No appetite for 3 days following vaccination. Chest pain/pressure and shortness of breath resolved after ~20 hrs. Headache resolved within 5 days. Fever resolved within 3 days. Fatigue and lethargic resolved within approximately 1 week.
41 2021-05-25 coordination abnormal, numbness, tingling Pt had first vaccine and four hours later felt her throat was "closing" off. She did not need any t... Read more
Pt had first vaccine and four hours later felt her throat was "closing" off. She did not need any treatment and it resolved. Right after that, a fever of 101 started and lasted 5-7 weeks. The first day she also had a sensation of painful skin all over that lasted one day. SHe had arthralgias and myalgias that lasted a week. A week after vaccine her right grip became weak and she felt n/t at times in her limbs and difficulty knowing where her feet were at times and coordination was off. This resolved almost completely before second immunization. When having second immunization, within a couple of hours later her symptoms of joint pain, muscle pain, lack of coordination and weakness and weakened grips worsened. THis has continued.
41 2021-05-25 facial pain, night sweats I developed a headache, dizziness, chills, and general unwell feeling a few hours after the shot. T... Read more
I developed a headache, dizziness, chills, and general unwell feeling a few hours after the shot. The headaches continue to occur everyday since the shot (5/14-5/26). Two days after the vaccine, I developed night sweats, which have occurred every night since then. Approximately a week after the vaccine, I woke up with swelling and pain in my shoulder and armpit area on the left side where I received the vaccine. The swelling and pain in the area has improved, but is not yet better as of today (5/26/2021). The swelling and pain moved into my neck area and is now in my face causing tightness and pain. I believe my lymph nodes are swollen due to the vaccine.
41 2021-05-25 migraine experience breakthrough menstrual bleeding; continued taking birth control regularly but was still e... Read more
experience breakthrough menstrual bleeding; continued taking birth control regularly but was still experiencing bleeding 3 days later; experienced migraine headaches; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 23Mar2021 13:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation; ethinylestradiol, norgestimate (TRI-SPRINTEC), route of administration, start and stop date, batch/lot number and dose were not reported to regulate menstrual cycle. Age at vaccination: 41 Years. The patient medical history was not reported. None known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient regulated her menstrual cycle with birth control pills. She was currently taking ethinylestradiol, norgestimate. At the time of her first vaccine appointment the patient was taking the first week of a new pack. The patient experienced migraine headaches 48 hours after her vaccine appointment. Five days after her vaccine the patient began to experience breakthrough menstrual bleeding. The patient had continued taking birth control regularly but was still experiencing bleeding 3 days later. The bleeding was light, not heavy like a normal period, but appeared dark and viscous. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Action taken of ethinylestradiol, norgestimate was unknown. Outcome of the event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
41 2021-05-26 discomfort, pain in extremity After the vaccination, around 9 PM 01/24/2021 I had arm pain that lasted about 12 hours. About 4 da... Read more
After the vaccination, around 9 PM 01/24/2021 I had arm pain that lasted about 12 hours. About 4 days after the vaccine on 01/28/2021 there was a prolonged period of time where my chest felt heavy and it was hard to breath, I felt like I was overweight. It wasn't as bad enough for me to use my inhaler. I had shortness of breath as well. The chest pain lasted about a month and a half. The shortness of breath lasted about a month and a half as well. The air felt very thick. Fatigue was about 2 PM the same day of vaccine on 01/24/2021 where it felt like my body shut down and I had to take a nap.
41 2021-05-26 involuntary muscle movements Hearing go out and tinnitus in one ear intermittently for 2 weeks; Hearing go out and tinnitus in on... Read more
Hearing go out and tinnitus in one ear intermittently for 2 weeks; Hearing go out and tinnitus in one ear intermittently for 2 weeks; Muscle jerking in arm, stomach, and one toe; Headache; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8731), via an unspecified route of administration in the left arm on 10Apr2021 at 00:00 (at the age of 41-years-old), 1st dose, single, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 11Apr2021 at 13:00, the patient experienced hearing went out, tinnitus in one ear intermittently for two weeks; muscle jerking in arm, stomach, and in one toe and headache. The patient underwent lab tests and procedures which included nasal swab COVID-SARS PCR test: negative on 21Apr2021. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.
41 2021-05-26 feeling cold 5/3/21-Contacted by individual to report that she has tested positive for COVID-19 test result with ... Read more
5/3/21-Contacted by individual to report that she has tested positive for COVID-19 test result with the following symptoms: cough, chills, headache, sore scratchy throat, congestion, runny nose, loss of smell, and fatigue. She has been Vaccinated x 2 with Pfizer COVID vaccine and denies any chronic conditions or medications.
41 2021-05-26 pain in extremity Mild welts on face; sore arm; mild headache; This is a spontaneous report from a non-contactable con... Read more
Mild welts on face; sore arm; mild headache; This is a spontaneous report from a non-contactable consumer. A 41-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) via an unspecified route of administration on 26Feb2021 as 1st dose, single for COVID-19 immunization. Facility type vaccine was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient did not had known allergies. Medical history was reported as no and concomitant medications were not reported. The patient experienced mild welts on face on 3rd day after first shot In addition to sore arm and mild headache on 28Feb2021. The patient did not received treatment for the events. The outcome of the events was reported as recovered on an unspecified date. No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
41 2021-05-26 pain in extremity sore arm; a shooting pain towards her armpit going down her arm; chills; diarrhea; This is a spontan... Read more
sore arm; a shooting pain towards her armpit going down her arm; chills; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection), via an unspecified route of administration on 16May2021 (at an age of 41-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced sore arm, a shooting pain towards her armpit going down her arm, chills, diarrhea. Consumer reported that after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine yesterday, 16May2021, she had a sore arm, a shooting pain towards her armpit going down her arm, chills and diarrhea. She said she took Advil for her arm discomfort, but was told by a friend that she should not have taken the medication. She also said she was told that she should have taken Tylenol instead of Advil. She called to seek guidance regarding this. Consumer also said that in all the forms she has, there was no information about taking medications at the same time with taking the vaccine. Therapeutic measures were taken as a result of sore arm, a shooting pain towards her armpit going down her arm. The clinical outcome of the sore arm, a shooting pain towards her armpit going down her arm, chills, diarrhea were unknown.
41 2021-05-26 pain in extremity Left arm pain, a light throbbing chest pain near arm pit throughout the 2nd and 3rd day after shot.
41 2021-05-27 facial pain 5/19-injection site pain, muscle aches, sore throat, (Tylenol taken every four hours) 5/20-injection... Read more
5/19-injection site pain, muscle aches, sore throat, (Tylenol taken every four hours) 5/20-injection site pain, muscle aches (Tylenol administered every 4 hours) 5/21- sore throat, muscle aches, low grade fever, (Tylenol taken every 4 hours) 5/22- extreme sore throat (burning sensation), ear ache, cough, headache, low grade fever, lost voice,(Tylenol taken, hot tea, throat lozenges, gargle with warm salt water) 5/23-sore throat, headache, cough,(Tylenol taken, hot tea, throat lozenges, gargle with warm salt water)5/24- sore throat, runny nose, cough, facial pain, ear ache, voice returned,(Tylenol taken, hot tea, throat lozenges, gargle with warm salt water) 5/25- persistent cough, runny nose, 5/26-dry cough, 5/27- dry cough, 5/28-dry cough, I am currently having coughing uncontrolled dry coughing fits which last a few minutes in duration.
41 2021-05-27 hot flush Had chills and hot flashes. Fever got up to 101.4. I couldn't keep any food or liquid down for 48 ho... Read more
Had chills and hot flashes. Fever got up to 101.4. I couldn't keep any food or liquid down for 48 hours. This all began 12 hours after getting the shot. A week later my face began breaking out. It's either pimples or rosacea.
41 2021-05-27 numbness Woke abruptly early morning of 4/27 with a racing heart, palpitations, and numbness in hands and fee... Read more
Woke abruptly early morning of 4/27 with a racing heart, palpitations, and numbness in hands and feet. Ambulance arrived and discovered my blood pressure was very high (157/104) and took me to the ER. Bloodwork and other diagnostic tests (EKG, chest x-ray) did not reveal an emergent heart issue and palpitations resolved, though blood pressure remained somewhat elevated. Discharged same day with directive to see cardiologist. Followed up with cardiologist two days later. Blood pressure remained elevated. Additional tests (echocardiogram, stress test, holter monitor) were ordered and I was instructed to monitor my blood pressure at home and return to the office in a few weeks. Test results came back normal. At home blood pressure monitor revealed elevated and fluctuating blood pressure readings lasting another 9 days. On the 10th day (exactly 14 days after receiving second vaccine dose), blood pressure completely normalized and has remained normal and not fluctuating since that date. Prior to this incident my blood pressure has always been normal at annual physicals, and was last elevated 14 years ago (in 2007) when I had preeclampsia in connection with my daughter?s birth, which resolved within a few weeks of the birth.
41 2021-05-27 tingling, burning sensation May 14 application of the vaccine, May 15 severe headache, May 16 tingling and itching in the extrem... Read more
May 14 application of the vaccine, May 15 severe headache, May 16 tingling and itching in the extremities of my body and head, face, tongue, loss of strength in my fingers on my left hand. Today is May 28 and the symptoms continue with less improvement. I feel burning in my hands and feet.
41 2021-05-27 tingling, pain in extremity A week after vaccine, I experienced my right arm hurting and having tingles. This has not gone away ... Read more
A week after vaccine, I experienced my right arm hurting and having tingles. This has not gone away and I currently feel my right arm still not the same way it was before the vaccine.
41 2021-05-28 weakness Stinging whelps and hives on injection; Stinging whelps and hives on injection; bump arose 3 inches ... Read more
Stinging whelps and hives on injection; Stinging whelps and hives on injection; bump arose 3 inches approximately from injection; throat swelling; nausea; diarrhea; itching; headaches; chills; dizziness; weakness; congestion; exhaustion; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 12B3) via intramuscular route of administration in left arm on 14Jan2021 at 12:00 PM as single dose for COVID-19 immunization. The patient medical history included hypothyroidism, hypertension, allergies year round and allergies ciprofloxacin, penicillin, peaches, bananas, strawberry, cockroaches, trees, grass, dander, dust, mold, cats and dogs. The patient did not receive any other vaccine within 4 weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included, levothyroxine, amlodipine, setraline, losartan and women multivitamin. On 14Jan2021 at 12:15 PM, the patient experienced stinging whelps and hives on injection site with swelling, bump arose 3 inches approximately from injection, throat swelling, nausea, diarrhea, itching, headaches, chills, dizziness, congestion, weakness and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl. The case was considered as non-serious by the reporter. Since the vaccination, the patient had been tested for COVID-19 including nasal swab test on 15Jan2021 with result: negative and throat swab test on 29Jan2021 with result: negative. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
41 2021-05-28 facial paralysis, discomfort, cold extremities, feeling hot, numbness throat felt like she had been talking all day and swollen; felt that they were giving a shot; couldn... Read more
throat felt like she had been talking all day and swollen; felt that they were giving a shot; couldn't get a full breath; right side of her face drooped a little; tongue was swelling; face, lips, eyelids and around them were swollen; intermittent chest pain; heart it felt achy at times; had a head rush; felt very hot suddenly; her ear started ringing and buzzing; she could not hear well; she felt immediately as if someone was trying to put her to sleep; She felt heaviness in her body, and in her chest and said it felt as if someone was lying on top of her.; her nose and mouth started to become gray and blue in color; numbness in her left arm; face, lips, eyelids and around them were swollen; face, lips, eyelids and around them were swollen; couldn't get a full breath because of the heaviness on her chest; fingers stay cold a lot; This is a spontaneous report received from a contactable consumer. This 41-year old female consumer (patient) received BNT162B2 dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot Number: ER8730) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included allergic to shellfish and almonds from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced a head rush after the first dose of the Pfizer-BioNTech Covid-19 Vaccine and felt that they were giving a shot . Everything was normal but when she came home, within an hour and 20 minutes, she suddenly felt very hot, her ear started ringing and buzzing, and she could not hear well. She said she felt as if someone was trying to put her to sleep. When the caller went to wash her face, she noticed her face, lips, eyelids and around them were swollen. The right side of her face drooped a little, it looked different on the jaw than the other side. The caller's tongue was swelling and her throat felt like she had been talking all day and swollen. She felt heaviness in her body like a weighted blanket and in her chest and said it felt as if someone was lying on top of her, it was like she couldn't get a full breath because of the heaviness on her chest. She also noticed that her nose and mouth started to become gray and blue in color but she could still swallow. She also had residual symptoms such as numbness in her left arm , it,feels like its asleep and intermittent chest pain like her heart it felt achy at times. This has gone away but it would come and go and feel like it was lightning, like thunder in her chest. Her fingers stay cold to the touch a lot from where they bend down to the tips more on her left than anything. She did not take herself to the emergency room or the doctor for the events. The caller didn't seek medical care because she had some medications at home that were for allergies from her allergist and it helped with the swelling. The patient reported the medicine was a powder tablet that is dissolvable, unknown name, she thinks she may have used it once, it has numbers on it. The swelling went down to where she felt like she was fine after taking them. The swelling in her face and her eye lids were puffy for a few days. The patient had blood work done the day of the vaccine, prior to receiving the vaccine and an electrocardiogram (EKG). Therapeutic measures were taken as a result of throat felt like she had been talking all day and swollen, tongue was swelling, face, lips, eyelids and around them were swollen, face, lips, eyelids and around them were swollen, face, lips, eyelids and around them were swollen. The outcome of right side of her face drooped a little was unknown, recovered from head rush, felt very hot suddenly, ears started ringing buzzing, couldn't hear well, trying to put her to sleep, face was pounding, face, lips, eyelids and around them were swollen, tongue was swelling, felt like something was heavy on her body, heaviness on her chest, blue and gray around her nose and mouth, chest was hurting, trying to put her to sleep, and felt that they were giving a shot on 06May2021, recovered on 09May2021 from face, lips, eyelids and around them were swollen, recovered on 10May2021 from chest was hurting and recovering from fingers stay cold a lot and numbness in her left arm. No follow-up attempts are needed. No further information is expected.
41 2021-05-28 feeling hot, tingling, numbness Immediately after injection felt suddenly a hot sensation throughout body, heart started pounding ra... Read more
Immediately after injection felt suddenly a hot sensation throughout body, heart started pounding rapidly and uncontrollably, especially on left side of chest, entire left arm started tingling and becoming numb down to my fingertips. I felt like impending doom and windpipe felt like it was starting to close up. I dialed 911 and took two puffs of my inhaler to open up my lungs.
41 2021-05-28 hot flush Hot flashes; This is a spontaneous report from a contactable Nurse(patient) A 41-years-old no pregn... Read more
Hot flashes; This is a spontaneous report from a contactable Nurse(patient) A 41-years-old no pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Feb2021 19:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation . Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced hot flashes) (non-serious) on 22Feb2021 with outcome of not recovered. No treatment received. Additional information: Facility type vaccine: Hospital;No other vaccine in four weeks.No Covid prior vaccination.No Covid tested post vaccination No follow up attempts are possible; information on Lot/batch number cannot be obtained.
41 2021-05-28 night sweats Night sweats; little shortness of breath; white dots on back of throat; Throat pain; bunch of bumps ... Read more
Night sweats; little shortness of breath; white dots on back of throat; Throat pain; bunch of bumps on the back of her tongue/throat; little cough; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number EL3248) via an unspecified route of administration in left arm on 12Jan2021 as unknown, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was also reported that on 12Jan2021 patient took the Pfizer COVID vaccine and 3 days later i.e., on 15Jan2021, she had night sweats and a little shortness of breath, like upstairs, or if she runs too fast, or talks too much, that was pretty much for two weeks now, then the last 2 days she had white dots, white dots in the back of her throat, and she went to urgent care and it was negative for strep, she was prone to strep. They said it was not strep, she was having throat pain, and now that morning, she had a bunch of bumps on the back of her tongue, and she was given Clindamycin, she wondered if the throat pain was related to the vaccine, she got tested for strep, and they said it was negative so now maybe it was related to the vaccine. Night sweats outcome: if she puts on a fleece blanket, which she loves to as she was always cold, but now she cannot unless she was waking up with a drenching sweat, and she did not sweat. She did not call about the sweats, since she thought she was 41, and it maybe that, but then with more thought it could be the vaccine. She did light jogs up and down stairs, she walked all over the hospital, and never got out of breath, and now she had to stop and breathe in deep. She had a little cough every now and then, and when she went to urgent care, because of the cough and her throat hurting, they did a COVID test, and it was negative. She told them she got vaccinated, they said they would still do the test, it was a rapid COVID, in the office strep and they put strep in the lab for 3 days. For white dots: her throat was hurting a while, and she looked with a flashlight and saw white dots, now states this was more than 3 days ago, the test took 3 days, so this was 4 or 5 days since she saw white dots. Last night, she did not see before the bumps in the back of her throat, she thought she had food in the back of her throat, she felt something there, and she looked at it with a flashlight and now she has bumps in the back of her throat, she tried to remove what was in the back of her throat. She did not see the white dots anymore, before the test came in, when they saw white dots. Treatment included clindamycin which was at home and she has not started. On an unspecified date in Jan2021, the patient underwent lab tests and procedures which included rapid COVID test and strep test with results of negative. The outcome of the events was unknown. Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
41 2021-05-28 pain in extremity Sudden fatigue; mild arm soreness; mild headache; This is a spontaneous report from a contactable Co... Read more
Sudden fatigue; mild arm soreness; mild headache; This is a spontaneous report from a contactable Consumer (patient). A 41-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: unknown), via an unspecified route of administration, in Left Arm on 25Feb2021 at 12:00 (at 41 years) at single dose for covid-19 immunisation . Medical history included Wegener's Granulomatosis, asthma, osteoarthritis (OA) and more (as reported). Patient had known allergy to trazodone and temazepam (RESTORIL). Concomitant medications (in two weeks) included multi vitamin, omeprazole (PROTONIX), azathioprine (IMURAN), clopidogrel bisulfate (PLAVIX), rosuvastatin calcium (CRESTOR). On 26Feb2021at 13:00 the patient experienced Sudden fatigue, mild arm soreness and mild headache. No treatment given. The outcome of the events was recovering. No follow up attempts are possible; information on Lot/batch number cannot be obtained.
41 2021-05-28 pain in extremity My arm hurt for 1-2 days. The first day was pretty extreme muscle pain and I felt slightly tired. Th... Read more
My arm hurt for 1-2 days. The first day was pretty extreme muscle pain and I felt slightly tired. The unusual thing was I had 10 days of heavy cervical mucus discharge. I have never had anything like this, but especially not at 41 years old. After that, my period started 10 days late. My period is very normal and predictable usually. These two events were not normal for me.
41 2021-05-28 pain in extremity Sore arm; Minor swelling at injection site; Headache; Low-grade fever the next day (99 degrees); Thi... Read more
Sore arm; Minor swelling at injection site; Headache; Low-grade fever the next day (99 degrees); This is a spontaneous report from a contactable consumer (patient). A 41-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 28Jan2021 at 14:30 (at the age of 41 years) as 1st dose, single dose for COVID-19 immunisation. Medical history included being treated for Grave's Disease, hyperthyroidism, food allergies to tree nuts and pitted fruit. Concomitant medications included methimazole 2.5 mg daily taken for an unspecified indication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 29Jan2021 at 00:00, the patient experienced sore arm, minor swelling at injection site, headache, and low-grade fever 99 degrees. Patient received no treatment for the events. Patient did not test for COVID-19 post vaccination. The outcome of the events was recovering. Information about lot and batch number has been requested. Follow-up attempts have been completed and no further information is expected.
41 2021-05-28 tingling, numbness arm numbness and tingling; arm numbness and tingling; This is a spontaneous report from a contactabl... Read more
arm numbness and tingling; arm numbness and tingling; This is a spontaneous report from a contactable other hcp. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP6955), via intramuscular, administered in Deltoid Left on 26Mar2021 15:09 as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing iron deficiency anaemia Prior to Jun2020 and burning sensation from Oct2020 to an unknown date. The patient's concomitant medications were not reported. Patient did not take other vaccine prior to COVID-19 vaccination. After 1st Covid-19 vaccine on 26Mar2021, she developed numbness and tingling down her entire let arm which resolved within about 48 hours. The events were reported as serious (important medical event). No treatment was received for events. The outcome of the event was reported as recovered in Mar2021. No follow-up attempts are needed. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of numbness and tingling cannot be excluded.But also consider medical history of burning sensation and iron deficiency anaemia.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
41 2021-05-28 tingling, tremor, numbness and pain in extremities Heavy period Trouble with vision Eyelids swollen Erratic Heart rate Blood pressure Shaking Thr... Read more
Heavy period Trouble with vision Eyelids swollen Erratic Heart rate Blood pressure Shaking Throat swelling Tingling in feet/hands No appetite Weight loss Pressure on chest Cough Ulcers in mouth Neuropathy These symptoms have been going on and have not let up. Currently on Lyrica .
41 2021-05-29 numbness, muscle spasms, tingling, weakness On 4/03/2021 awoke with sharp under scapula pain with loss of power to left serratus anterior that m... Read more
On 4/03/2021 awoke with sharp under scapula pain with loss of power to left serratus anterior that manifested over the next weeks into severe axillary anterior and posterior spasms with tingling down left arm thumb, index and middle finger. Numbness to fingers thereafter and then significant loss of strength came after that especially to tricep, teres major and hand. Started dropping stuff on the floor and am unable to perform my full job duties at this time. Treatment and pain/weakness/tingling symptoms are ongoing
41 2021-05-30 muscle spasms Severe bloating, constipation, cramping, distended belly soon after receiving the 1st COVID vaccine.... Read more
Severe bloating, constipation, cramping, distended belly soon after receiving the 1st COVID vaccine. I had an emergency appendectomy on 29 May 2021. I had acute appendicitis with localized peritonitis, without perforation or gangrene. Admitting and attending physician, MD.
41 2021-05-30 night sweats Chills, night sweats, fever of 103.5, brown urine, body aches, shortness of breath, rapid heart rate... Read more
Chills, night sweats, fever of 103.5, brown urine, body aches, shortness of breath, rapid heart rate, eye twitching
41 2021-05-30 tenderness swollen lymph node in left armpit started 5/30/21 @ 1:30pm. Very sore to the touch
41 2021-05-31 tingling The day after I received dose 2, 04/13/2021, I started having pain behind my eyes. I was feeling ver... Read more
The day after I received dose 2, 04/13/2021, I started having pain behind my eyes. I was feeling very fatigued. I had to take painkillers to help get through the day. I had a lasting headache for a whole week. My right armpit became swollen and sore. On 04/15/2021, I felt tingling on the left side of my body with mild dizziness and anxiety. I had a virtual visit with Dr. on 04/16/2021. I also had knee pain which is unusual for me. During my virtual visit, Dr. informed me that she felt fatigue for the week after she received her vaccine too. I was told that if my symptoms continue to follow up with the doctor. As of today, 06/01/2021, I can still see where I received the vaccination. I have a red bump there. It does not hurt, but it is noticeable.
41 2021-05-31 tingling Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: fingers tingling-Medium, Additional D... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: fingers tingling-Medium, Additional Details: pt complained of chest pain after injection & tingling in fingers-bp was taken-143/82 -called 911 & they checked her out in ambulance-paramedics released her a few minutes later to go home
41 2021-06-01 burning sensation, sciatica, tingling, numbness, feeling cold Severe dizziness ( started at around 15 minutes after injection), cold followed by hot burning sens... Read more
Severe dizziness ( started at around 15 minutes after injection), cold followed by hot burning sensation on upper parts of both arms. Numbness in both hands, low back pain (sciatica flare up, especially on right side). Right side of right leg (calf into foot) numbness, with constant "nerve zaps". Entire right arm and right leg experience complete numbness (and the sensation of sharp "pins and needles"). This has been going on now for over a week (started night one after receiving shot). Deep muscular pain on underside of right leg. Dizziness is recurrent and random. Random itchiness throughout body (hives appeared once on right foot). Pain and tightness of chest (pain occurred 3 days after shot, tightness immediately when reactions occurred).
41 2021-06-01 muscle spasms She got her vaccine, she had no reactions at all. On 5/12/21, she woke up 2 days with ankle and fee... Read more
She got her vaccine, she had no reactions at all. On 5/12/21, she woke up 2 days with ankle and feet swelling, hand and face swelling, eyelid swelling. She had a fever up to 100.5. Her swelling has not gone down on any of the locations. She cannot even take her wedding bands off. Her feet are extremely cramped in her shoes. Her allergies have gone tremendously. She has been throwing up and have been nauseous a lot. She has not been taking anything but Benadryl for the reactions. She also has gained 7# since the vaccine. Her hands have also been shaky. She has not notified her doctor of any of these symptoms.
41 2021-06-01 pain in extremity, tingling, numbness This is a spontaneous report from a contactable consumer or other non healthcare professional (HCP).... Read more
This is a spontaneous report from a contactable consumer or other non healthcare professional (HCP). The patient reported for self. A 41-years-old (non-pregnant) female patient received BNT162b2 (Formulation: Solution for injection; Lot Number and Expiration date: UNKNOWN) , via intramuscular route of administration on, Solution for injection) (reason for unknown Lot number: Unable to locate or read the details), via an unspecified route of administration on 30Apr2021 (at 41-years-old) as single dose for COVID-19 immunisation. Patient medical history included known allergies to Penicillin, Sulfa from an unknown date and unknown if ongoing. Concomitant medication (other medications the patient received within 2 weeks of vaccination) included estradiol (.025mg patch) taken for an unspecified indication, start and stop date were not reported. No other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 02-May2021 the patient experienced Bruising of legs, calf area. Severe throbbing in both legs, numbness and tingling in both feet and toes. No distal pulse in right foot. Anxiety, due to worry of health after the vaccine. The patient had been tested for COVID-19, underwent lab tests and procedures which included Nasal Swab test (sars-cov-2 test) result was negative on 06May2021. Patient underwent venous and arterial ultrasounds of unknown results. Therapeutic measures were taken for the events occurred. Events were reported as non-serious. The outcome of the events was reported as recovered on an unspecified date. Information on the lot/batch number has been requested.
41 2021-06-01 pain in extremity Excruciating pain to right arm and severe right axillary lymphadenopathy; treatment is supportive, o... Read more
Excruciating pain to right arm and severe right axillary lymphadenopathy; treatment is supportive, outcome to be determined.
41 2021-06-01 pain in extremity Site: Pain at Injection Site-Severe. Additional Details: Pain in arm, unable to lift arm without pai... Read more
Site: Pain at Injection Site-Severe. Additional Details: Pain in arm, unable to lift arm without pain.
41 2021-06-01 tingling Immediately developed a metallic taste in her mouth that lasted for 4 days. Within 15-20 minutes of... Read more
Immediately developed a metallic taste in her mouth that lasted for 4 days. Within 15-20 minutes of receiving vaccine she developed tingling of her face and numbness of her tongue - this persisted for 10-15 minutes. She reports feeling drunk and disoriented for 3-4 days after vaccination.
41 2021-06-02 bell's palsy Bell's Palsy; This is a spontaneous report from a contactable consumer reported for herself. A 41-ye... Read more
Bell's Palsy; This is a spontaneous report from a contactable consumer reported for herself. A 41-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 30Apr2021 10:00 for Covid-19 immunization. Medical history and concomitant drug were not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr2021 for Covid-19 immunization. The patient reported events diagnosed as Bell's Palsy, left sided facial droop, inability to move the left forehead, left facial numbness, inability to close the left eye. The adverse event started since 14May2021. Treatment included prescription of a seven-day course of Prednisone, etc. The adverse event result in Emergency room/department or urgent care. Outcome of the event was not resolved. Since the vaccination, the patient has not been tested for COVID-19. The report was not assessed as serious. Information on the lot/batch number has been requested.
41 2021-06-02 pain in extremity Sometime in March patient reports having left sided hip pain that radiated down her left leg. State... Read more
Sometime in March patient reports having left sided hip pain that radiated down her left leg. States it went away on its own but returned again this week. Two years ago she was treated for lower back pain after a car accident.
41 2021-06-03 weakness throwing up non stop/throwing up all fluids now; feeling really woozy; Nauseous; Diarrhea; Sluggish;... Read more
throwing up non stop/throwing up all fluids now; feeling really woozy; Nauseous; Diarrhea; Sluggish; she broke out in a sweat; all her energy went away; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 20May2021 at 11:15 (Lot Number: EW0168) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she just got her first dose of Pfizer COVID vaccine at 11:15 am on 20May2021. At around 12:30 or 1pm, she started feeling really woozy and nauseous. Since 2:3 or 3:00pm, she has been throwing up non-stop. She stated that all her energy went away, felt sluggish was nauseous and she broke out in a sweat. She even had diarrhea a few times and that threw her off. She was throwing up all fluids now and she was scared to drink anything. The patient did not receive treatment for the events. the events did not require a visit to emergency room or physician office. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
41 2021-06-03 bell's palsy, facial paralysis I got my second shot on 1/27/21, woke up Thursday morning and told my husband my tongue felt funny l... Read more
I got my second shot on 1/27/21, woke up Thursday morning and told my husband my tongue felt funny like it was numb. On Friday 1/29/21 went to work and as the day progressed I noticed it was difficult to eat lunch and then went home and noticed drooping of have my face. I called my employer and PCP, they told me to go to urgent care. They diagnosed me with Bells Palsy and prescribed and antiviral and steroid. I had a follow up with my PCP. It took about 3 weeks before my face returned to normal.
41 2021-06-03 pain in extremity, tingling Painful rash on both legs; Painful rash on both legs; Colors range from red with variations of purpl... Read more
Painful rash on both legs; Painful rash on both legs; Colors range from red with variations of purple looking and feeling bruised with no injuries, sometimes brown also,; my legs and they are swollen; tingling sensations in my right and left hands; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received second dose of BNT162B2 (lot number: EN6203) on 19Mar2021 (41-year-old) on left arm at single dose for COVID-19 immunization. Medical history were none. Concomitant medications included bupropion hydrochloride (Wellbutrin), topiramate (TOPAMAX), phentermine, montelukast sodium (SINGULAIR). Historical vaccine included first dose of BNT162B2 (lot number: EN6202) on 26Feb2021 (41-year-old) at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered Hospital. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Patient had Painful rash on both legs that continues to change on 31Mar2021. It has been on knees down in different places. The spots on the back of her lower legs continue to hurt. Colors range from red with variations of purple looking and feeling bruised with no injuries, sometimes brown also, mornings it is painful to stand on my legs and they are swollen , also some tingling sensations in her right and left hands. The events were occurred on 31Mar2021. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event: Steroid shot, prednisone, antibiotic. The outcome of the events was not recovered.
41 2021-06-03 pain in extremity Lightly sore arm; Slight headache; This is a spontaneous report received from a contactable consumer... Read more
Lightly sore arm; Slight headache; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 16Mar2021 at 15:15 (at the age of 41-years-old) as a single dose for COVID-19 Immunisation. The medical history of the patient included rheumatoid arthritis (RA), fibromyalgia and Hashimoto's thyroiditis. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrocodone (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), methotrexate (MANUFACTURER UNKNOWN), REMICADE, all for an unspecified indication. The patient was allergic to MEDROL. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021 at 11:00, the patient experienced lightly sore arm and slight headache. The patient did not receive any treatment for the events. The clinical outcome for the events pain in arm and headache were not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
41 2021-06-03 tingling Tingling in face and feet; elevated blood pressure; elevated heart rate; Dizziness; Brain fog; This ... Read more
Tingling in face and feet; elevated blood pressure; elevated heart rate; Dizziness; Brain fog; This is spontaneous report from a contactable consumer, the patient. A 41-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 10:45 (at the age of 41-years-old) as a single dose for Covid-19 immunisation. The patient medical history included asthma, reflux and migraine from unknown date. Allergies to medications, food, or other products was reported to cats. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included meloxicam, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), all for unknown indication from unknown date. The patient experienced tingling in face and feet, elevated blood pressure, elevated heart rate, dizziness and brain fog on 17Mar2021 at 10:45. The patient did not receive treatment for the reported events. The clinical outcome of the tingling sensation, elevated blood pressure, heart rate increased, dizziness and foggy feeling in head was recovering. No follow-up attempts are possible, information about batch number cannot be obtained.
41 2021-06-04 numbness lost feeling in legs; nausea; Dehydration; insomnia; This is a spontaneous report received from COVA... Read more
lost feeling in legs; nausea; Dehydration; insomnia; This is a spontaneous report received from COVAES from a contactable consumer (patient). A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 14:30 at the age of 41-years-old (Batch/Lot Number: ER2613) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no any other medications the patient received within 2 weeks of vaccination. The patient experienced lost feeling in legs 10 days after 2nd vaccine (as reported), extreme nausea, dehydration and extreme insomnia on 15May2021 04:00 with outcome of recovering. Since the vaccination, the patient had not been tested for COVID-19.
41 2021-06-05 flushing Systemic: Flushed / Sweating-Medium, Additional Details: at 12:25pm had extreme sweating, BP at 12:3... Read more
Systemic: Flushed / Sweating-Medium, Additional Details: at 12:25pm had extreme sweating, BP at 12:31pm was 137/87 pulse of 82, turned fan on for patient and had her elevate legs. Patient felt better at 12:40pm and left, advised no to drive until felt better.
41 2021-06-05 tremor 6/5/2021- Dizziness, loss of consciousness, nausea, vomiting, diarrhea, shaky arm
41 2021-06-06 numbness, tingling 5 minutes after receiving the vaccine, I experienced pronounced numbness and tingling in my hands an... Read more
5 minutes after receiving the vaccine, I experienced pronounced numbness and tingling in my hands and feet. The nurses at the vaccination facility had me stay an hour to make sure no further reaction developed. I went home. The significant numbness/tingling continued for three days, then subsided to a lower level that was still noticeable. Since then, numbness and tingling has increased and decreased off and on. It is esp. bad today. A neurologist said that the vaccine likely caused inflammation that triggered my neuropathy and that I should avoid a second dose as the reaction would likely be worse.
41 2021-06-07 bell's palsy Bell?s Palsy on right side of face
41 2021-06-07 brain damage Sudden onset short term memory loss. Testing has included MRI, CT, EEG, extensive blood tests, inclu... Read more
Sudden onset short term memory loss. Testing has included MRI, CT, EEG, extensive blood tests, including Lab (rare neurological disorders). All are normal. SARS test was negative with disclaimer that it didn't eliminate the possibility of her having Covid. Currently receiving high dosage of Prednisone for "encephalopathy" diagnosis. She is not responding. This has been going on for 3 months.
41 2021-06-07 numbness Gland in throat became very swollen, under left ear (side of vaccination in arm). Gland became so sw... Read more
Gland in throat became very swollen, under left ear (side of vaccination in arm). Gland became so swollen that my face went numb for 2 days on the left side.
41 2021-06-08 cold sweat About a month and 20 days after my second vaccine I had trouble breathing. I work in the hospital, s... Read more
About a month and 20 days after my second vaccine I had trouble breathing. I work in the hospital, so I thought maybe it was bronchitis, the mask made it harder to breathe. I had the weekend off and decided by Monday I would go to the doctor if not better. I woke up on Sunday, still achy, not wanting to move, couldn't really eat, I was just mostly drinking water. I woke up Monday and came back to bed, moved the blanket and then could barely breathe. My skin got very clamy, feeling scared and unsure if it was a heart attack. I called 911 and was taken to hospital to a shock trauma. I am only back to work 4 hour days, and working with a pulmonologist.
41 2021-06-08 pain in extremity Ongoing, worsening pain in L arm for 4 weeks after injection. Pain radiates to wrist and to scapula.... Read more
Ongoing, worsening pain in L arm for 4 weeks after injection. Pain radiates to wrist and to scapula. Causing patient to miss work. Has tried ice, heat, ibuprofen, hydrocodone, and lidocaine patches with limited benefit. Imaging work-up and physical therapy eval pending.
41 2021-06-08 tingling Patient was given the first Pfizer COVID19 vaccine around 5:36pm. While waiting her 15 minutes patie... Read more
Patient was given the first Pfizer COVID19 vaccine around 5:36pm. While waiting her 15 minutes patient states that she is itchy, has blotchy skin, swelling in her feet and hands, and tingling in her face and lips. She is immediately brought back into theimmunization room for observation. Patient declined ice pack. After no signs of anaphylaxis and since patient was conscious and coherent, gave 25mg of diphenhydramine around 6:00pm. Told patient to remain seated for observation. Checked patient's bloodpressure at 6:12pm and it was 144/96 with pulse of 90. Patient states her blood pressure normally runs below 120/80. Brought patient back into immunization room for more monitoring. Patient states that symptoms are not improving. Recheck blood pressure at approximately 6:25pm and it was still elevated at 151/86 with pulse of 96. Patient declined ambulance ride and wanted to continue to be observed at the pharmacy. Continued to monitor patient and call pharmacy manager and market manager. Patient states that she has taken Benadryl and Zyrtec in the past for a previous allergic reaction and it did not lessen the symptoms. Discussed taking hydroxyzine and went over possible adverse reactions especially extreme drowsiness before giving to patient. Patient's husband was with her and would be driving her home. Gave hydroxyzine hcl 25mg approximately at 7:25pm and observed patient for additional 15 minutes. Patient felt comfortable enough to leave and go home with her husband. She stated that she has an epi pen and blood pressure monitor at her house and will continue to monitor symptoms and her blood pressure. Agreed if worsening symptoms to seek medical attention. Patient left pharmacy approximately at 7:40pm.
41 2021-06-08 unresponsive to stimuli, cold sweat Pt was very nervous about the injection. It was determined that she had anxiety related to the injec... Read more
Pt was very nervous about the injection. It was determined that she had anxiety related to the injection. She passed out and was unresponsive at times, cold sweats, limp. There were no signs of swelling or throat closing. and airways were clear. All vitals were normal following the event, 911 was called and arrived within 5-10 minutes and check vitals again then administered oxygen and she became more responsive. Blood sugar was also checked with a hand-held device and finger stick blood sample. It was determined that she should go top the hospital for additional care and tests.
41 2021-06-09 pain in extremity My left arm hurt and it was hard to lift above my head. It has remained painful and I am having diff... Read more
My left arm hurt and it was hard to lift above my head. It has remained painful and I am having difficulty using it.
41 2021-06-09 tingling, bell's palsy, numbness She stated that if this was Bell's Palsy, it is a mild case; stiffness on left side of face from nec... Read more
She stated that if this was Bell's Palsy, it is a mild case; stiffness on left side of face from neck to eye/ face is still stiff; Piercing pain behind left ear and her tongue and lips; Tingling on left side of face from neck to eye/face went numb and tingling/ tongue and lips, and everything was tingling; numbness on left side of face from neck to eye/face went numb; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 08Mar2021 at 14:45 (Batch/Lot Number: EN6206) as 1st dose, single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Medical history included food allergy to mango. The patient's concomitant medications were not reported. The patient experienced tingling, numbness, stiffness on left side of face from neck to eye, and piercing pain behind left ear on 08Mar2021 at 15:00. The adverse event resulted in Emergency room/department or urgent care. There was no treatment received for the adverse event. The patient was not diagnosed with COVID-19 Prior to vaccination and has not been tested for COVID-19 since the vaccination. Course of events were as follows: The patient reported that on a Monday (08Mar2021), she went for first COVID-19 vaccine. She stayed for 20 minutes and everything was fine then while driving home her face went numb and tingling as if she had a Novocaine injection. She had a piercing pain behind the left ear and her tongue and lips, and everything was tingling. She called and was told to get to an Emergency room fast. She pulled into an immediate care. Her vitals were fine. Her throat was not closing and was not anaphylactic. The facility didn't know what to tell her because they do not know much about the COVID-19 Vaccine. She was advised by immediate care to either go home or go to the Emergency Room. She went home but did not drive herself. She stated this was Monday. As of Wednesday (10Mar2021), her face is still stiff. She doesn't think she has a full Bell's Palsy where the face is drooping and stiff. She called her doctor and was advised by her doctor to get the second COVID-19 vaccine, but to stay at the facility for a couple of hours so an ambulance could be called if necessary. She did not (incomplete report) her doctor's advice. She stated that if this was Bell's Palsy, it is a mild case. She asked if she should go for the second COVID-19 vaccine and asked if the second COVID-19 vaccine would be worse and if she would have a full sagging face. She can't find anyone to tell her this. She confirmed she already completed a report with Pfizer safety online reporting. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
41 2021-06-10 pain in extremity Starting on the day of the vaccine 2nd dose, I had a fever that evening. I had a lot of pain on my... Read more
Starting on the day of the vaccine 2nd dose, I had a fever that evening. I had a lot of pain on my left arm and high heart rate. I took Tylenol for the symptoms. I woke up the next morning and felt ok. After 2 days, I noticed a red rash on my chest. It was not itchy or painful. I went to Urgent Care and the doctor recommended ice pack and the rash went away. After 10 days, I had diarrhea and nausea. I went to Urgent Care again, I was given Zofran medication for nausea and they ran some tests which all came back normal. The nausea and diarrhea went away after 2-3 days. Currently, I still have a little bit of difficulty breathing and shortness of breath.
41 2021-06-12 weakness I received the 2nd shot wed afternoon, 2 days later Saturday early morning woke with sudden onset ac... Read more
I received the 2nd shot wed afternoon, 2 days later Saturday early morning woke with sudden onset acute hearing loss B ears and tinnitus. Worsened Sunday . Monday I went to ENT doctor 130 pm he confirmed I have SSHL left ear significant. We discussed treatments of steroid injection due to my intolerance of oral steroids we discussed getting the approval from (other doctor) if steroid injection to L ear would be a good treatment . MRI of brain also ordered . Later that day symptoms of severe dizziness, nausea and headaches , fuzzy head , and high blood pressure , feeling like I would faint , went to the ER all night , BP came down, fluids given , labs stable still dizziness told to follow up With outpatient doctors . Called ENT he said for the approval for steroid injection and wants to wait for MRI . Next day nausea and dizziness and hearing loss worsens , horrible vomiting Tuesday night for 2 hours , horrible dizziness and hearing loss continues wed ENT prescribed anti nausea medicine to help . Wed went to Chiropractor clinic For consult and X-rays of the cervical spine to prepare for neck adjustment to relive some pressure and reduce dizziness and nausea . Thursay am went to get MRI of brain with contrast , results ordered stat - results came back no mass no bleed normal study . ENT calls with results and plan for steroid injection Tuesday 6/15 315 pm . I continue to go to chiropractic doctor for care to help reduce the dizziness and fuzzy head / headaches feeling . I present as Very weak and 9 lb on wt loss in 1 week due to dizziness and weakness . Unable to drive , work , barely can provide self care , or take care of my children . Still dizzy and not better
41 2021-06-13 burning sensation Full body rash, large hives on torso, legs, buttocks, and arms. Nothing notable at injection site. R... Read more
Full body rash, large hives on torso, legs, buttocks, and arms. Nothing notable at injection site. Rash comes on at night, itchy and burning. Taking Benadryl, but no sure it helps. I'm trying to avoid food and drinks with high histamine. Day time, it goes away. It started two days after injection and has been ongoing since (today will be day 5 of rash if it happens again this evening.)
41 2021-06-13 muscle spasms I had a typical reaction with my first dose. The second dose seem typical for the first 24hrs. After... Read more
I had a typical reaction with my first dose. The second dose seem typical for the first 24hrs. After that joint pain increased all over and I started having muscle spasms. The fever went away by Sunday but them my arm started to turn red, heat up and swell at the injection site. It started out about the size of a quarter and grew to the size of my palm by Monday afternoon. My shoulder started to hurt at that point and still hurts today. The pain is from the front all the way around to the shoulder blade and the headache that started on day 2 is still here.
41 2021-06-14 breast pain possible breast cancer; strong systemic reaction; throat swelling; tachycardia; rash; Repeated right... Read more
possible breast cancer; strong systemic reaction; throat swelling; tachycardia; rash; Repeated right breast ultrasound May 2021 due to pain and area felt larger and more tender.; Repeated right breast ultrasound May 2021 due to pain and area felt larger and more tender.; This is a spontaneous report from a contactable other HCP (Nurse, patient). A 41-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EJ1685, expiration date unknown) via an unspecified route of administration in the arm left on an unspecified date (reported as 18Dec2020 11:00 AM and pending clarification) at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included depression, anxiety, COVID-19. Patient had drug allergies to morphine and doxycycline. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EJ1685, expiration date unknown) via an unspecified route of administration in arm right on 18Dec2020 at 11:00 AM (as reported) at age of 41-year-old at 0.3 ml, single dose for COVID-19 immunization and had strong systemic reaction. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had usual regimen (unspecified) within 2 weeks of vaccination. It was reported that patient had strong systemic reaction with both doses. 2nd injection was sent straight from the employee health to Emergency Room due to throat swelling, tachycardia and rash. The most concerning was the area under her right Axilla found about 5 months ago. It's was originally a small bean size area. Patient had seen her primary care physician and she could felt it so got a mammogram and breast ultrasound and the radiologist did see and confirm area but felt it was related to her recent COVID 19 vaccine. There was no family history breast issues. Patient had repeated right breast ultrasound in May2021 due to pain and area felt larger and more tender. Patient had an additional area of concern moving her to BARDS 3 concerning for possible breast cancer. Patient would repeat ultrasound in 1 month so Jun2021. Patient had never had any issues and had no family history. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient had emergency room visit and multiple PCP as treatment for the events. Seriousness criteria of the events was reported as disability or permanent damage. Outcome of the events was not recovered. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.; Sender's Comments: Based from temporal occurrence of events and vaccination schedule, the causal association of reported events in relation to suspected drug BNT162B2 cannot be totally excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
41 2021-06-14 discomfort, migraine Starting on the day after the vaccine 2nd dose, I got a very bad severe migraine like headache righ... Read more
Starting on the day after the vaccine 2nd dose, I got a very bad severe migraine like headache right away. I had extreme sensitivity to light and had to lay down. My left eye was getting blurry and I was feeling severe pressure and pain. I could not walk or stand up and felt very heavy. I had tinnitus (ringing in both ears) and painful inner ear pressure that exacerbated my headaches. The next day, my symptoms were getting worse and now I had pain in my neck and spine. My joints in my spine and neck felt swollen,inflamed and was very painful. I called my PCP and they recommended Tylenol and to go to Urgent Care. I was prescribed Prednisone and muscle relaxer. The medications did not help. My PCP then advised to go to the ER. They did blood work, 2 spinal taps, MRI and CAT scan. I was in the hospital for 1 night. Everything came back normal. I was discharge and instructed to let the vaccine run its course. I am still suffering with nausea, headaches, pain in neck and spine with no improvements. It has affected my quality of life and I am still out of work. I am unable to do simple daily tasks.
41 2021-06-15 hot flush AFTER VACCINE ADMINISTARTION PATIENT REPORTED GETTING HOT FLASHES. SHE DENIED ABOUT HAVING ANY OTHER... Read more
AFTER VACCINE ADMINISTARTION PATIENT REPORTED GETTING HOT FLASHES. SHE DENIED ABOUT HAVING ANY OTHER SYMPTOMS LIKE SOB, DIZINESS, ITCHING. BP AND HR WAS NORMAL (126/90 HR 86) SHE DID NOT HAVE ANY DRUG ELLERGIES. SHE WAS GIVEN A 10ML DOSE OF BENADRYL . AFTER MONITORING FOR A WHILE SHE CONFIRMED FEELING FINE DENIED FOR ANY HOT FLASHES, DIZINESS, SOB, ITCHING. COUNSELED FURTHER ON ANY POSSIBLE REACTION, TREATMENT AND REPORTING. WILL FOLLOW UP WITH PT AGAIN
41 2021-06-15 numbness, weakness, tingling As soon as I got the injection I felt my tongue burning/tingling and then tasted a heavy metallic ta... Read more
As soon as I got the injection I felt my tongue burning/tingling and then tasted a heavy metallic taste in my mouth. It lasted the whole day. It subsided after I ate later in the evening and then dissipated by the next day. Four days later I started to experience burning "Pins and Needles" feeling that would start from my left forearm down to my fingertips then I would feel it in my left foot in the toes. I could not sleep the whole night. The next day the pins and needles feeling intensified. It would hit all throughout my body on both sides. Then I could feel numbness in my fingers and toes. Working on the computer started to feel daunting like I couldn't even move the mouse on the computer. I had no motivation. When getting up, my body felt like Jello. I reported this to my family Dr, on Tues. 6/15/21. I am still feeling the symptoms today.
41 2021-06-15 pain in extremity I had an reaction within a few seconds, very dizzy and my heart rate increase. My heart was pounding... Read more
I had an reaction within a few seconds, very dizzy and my heart rate increase. My heart was pounding, 3 weeks of very fast heart rate, heart palpitations for 3 weeks, spikes in my blood pressure. Pain at the injection site and in my chest. Now have chronic hives across my chest and neck, now down my arms, lingering pain in my arm where I received the injection, I had a round of flu-symptoms.
41 2021-06-15 tingling, facial paralysis Half an hour after vaccination at 16:30, R lip numbness (resolved) started. Led to inability to hold... Read more
Half an hour after vaccination at 16:30, R lip numbness (resolved) started. Led to inability to hold water in mouth, requiring a straw to drink water, and L eye numbness (resolved) by 22:00. She arrived in ED at midnight and developed R side neck and occiput tingling (resolved during admission), blurry vision (first L eye then both eyes, persisted past discharge), and impaired balance/dizziness (improved but persisted past discharge). The patient was admitted to neurology floor and presented with a R peripheral CNVII palsy (R forehead weakness, R lagophthalmos, smile does not extend to R, persisted past discharge), R face paresthesia (persisted past discharge), and tongue deviation to L (persisted past discharge).
41 2021-06-15 tingling, numbness numbness and tingling in feet for 5 days (ongoing) pain in bilateral hips and knees x 1 day (resolve... Read more
numbness and tingling in feet for 5 days (ongoing) pain in bilateral hips and knees x 1 day (resolved)
41 2021-06-16 weakness, feeling cold I tested positive for pregnancy in 17Mar2021. In 24Mar2021 I got my first covid vaccine from Pfizer;... Read more
I tested positive for pregnancy in 17Mar2021. In 24Mar2021 I got my first covid vaccine from Pfizer; feel cold (really cold) all the time; feel weak; This is a spontaneous report from contactable consumer female (patient, mother reported for herself). A 41-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on right arm on 24Mar2021 at 07:15 hours, as 1st single dose (at the age of 41-years-old) for COVID-19 immunization. Medical history included dementia, patient was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. Patient had one previous pregnancy and no previous maternal pregnancy compilations. Concomitant medication included patient was taking Throne dietary supplement for prenatal supplement from 18Mar2021, daily and ongoing. First day of last Menstrual period was 14Feb2021. Estimated delivery of patient was 21Nov2021. Gestation period at the time of initial exposure was 2 weeks, 1st trimester. Patient had no problems before delivery. No drugs were taken by father (patient's husband) during the mother's pregnancy, father was non-smoker, did not drink alcohol and use illicit drugs during this pregnancy. The patient did not had allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. The patient tested positive for pregnancy in 17Mar2021. On 24Mar2021, she got her first COVID vaccine from Pfizer. Patient first appointment with her OB/GYN was in 05Apr2021. Her doctor did an ultrasound and checked the baby's vital signs. She confirmed that the baby was the right size, and the baby heartbeat was good. She said everything was ok with the baby. On 14Apr2021 she got her second Covid vaccine from Pfizer. Her vaccine was schedule at 10:00 AM. After she got the vaccine, she started to have cramps. About 1:00 PM she started bleeding (light red). She called her doctor and she told her to go to her office. About 1:45 PM She had a new ultrasound. Her doctor said that she did not find any heartbeat in the baby and that she was having an abortion. On 10May2021, it was reported that on unspecified date of 2021, after she got the vaccine, patient had some different symptoms like feel cold (really cold) all the time and feel weak. During all this time she was taking just Thorne-Dietary supplement. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular route of administration, administered on left arm on 14Apr2021 at 10:15 hours, as 2nd single dose (at the age of 41-years-old) for COVID-19 immunization. Patient called her doctor at 14:00 to 14:30 hours on 14Apr2021, during physician office visit, the doctor did a sonogram and she said that she was having a spontaneous abortion/miscarriage with 7 weeks (2 months) of gestational age. During the sonogram/ultrasound, no heartbeat was detected for fetal. Patient stated that it was the first time that she had miscarriage, her first pregnancy was normal, and her son was born. Patient got the 2 vaccines but wasn't informed about the Lot number. The outcome of feel cold (really cold) all the time and feel weak was unknown and not recovered for rest of the event. No follow-up attempts are needed. information about lot/batch number cannot be obtained. Follow up attempts are completed. No further information is expected. Follow-up (10May2021): This is a follow up-spontaneous report from a contactable consumer. This Consumer reported in response to EDP follow-up questionnaire which included that: New events was added. Pregnancy details, medical history and concomitant medication was added. Clinical course and text were amended accordingly.
41 2021-06-16 weakness, tremor pt has weakness. Trouble swallowing. Body stiffness. Flu Like symptoms. admitted to hospital a week ... Read more
pt has weakness. Trouble swallowing. Body stiffness. Flu Like symptoms. admitted to hospital a week for 2 days . Head shakes and gets very weak.
41 2021-06-16 weakness " Patient experienced fever, chills, neck pain radiating to head, mild weakness and dizziness. Pati... Read more
" Patient experienced fever, chills, neck pain radiating to head, mild weakness and dizziness. Patient denies any emergent concern at this time. Urgent care visit scheduled"
41 2021-06-16 feeling hot I have a lump, it's like a size of a golf ball on my arm; I did get a tiny little lump smaller than ... Read more
I have a lump, it's like a size of a golf ball on my arm; I did get a tiny little lump smaller than the marble. But it's worst today.; it's red; it's warm to touch/ like hot to touch; Achiness; Upper respiratory infection/ kind of had a runny nose; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8735; Expiration date: Jul2021), via unspecified route of administration in the left deltoid on 13May2021 (at the age of 41-years-old) as second dose, single dose for COVID-19 immunisation. The patient has no relevant medical history. Concomitant medications were not reported. The patient was preciously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER8735; Expiration date: 31Jul2021), via unspecified route of administration in the left arm, left deltoid on 22Apr2021 (at the age of 41-years-old) as first dose, single dose for COVID-19 immunisation. On an unspecified date in May2021, the patient experienced a tiny little lump smaller than the marble which became worst (reported as today) like a size of a golf ball on her arm and it was red and warm or like hot to touch, just kind of had a runny nose, achiness all day (reported as today) and upper respiratory infection that was not still bad. Treatment with Dayquil (2 tablets), Ibuprofen (800mg) and ice were taken as a result of the events. The outcome of the events was unknown. The relatedness of events lump, like a size of a golf ball on her arm and it's red and warm to touch and achiness was reported to be related and causality of all the events was reported as yes by the reporter. There was no investigation assessment. No follow-up attempts are needed. No further information is expected.
41 2021-06-16 hot flush, tremor, tingling Within 10min of the shot I experienced hot flashes all over my body. Then dizzy, nausea, diarrhea, b... Read more
Within 10min of the shot I experienced hot flashes all over my body. Then dizzy, nausea, diarrhea, body shakes, rapid heartbeats, tingling hands/feet.
41 2021-06-16 numbness, tingling, paralysis After Dose 1 (given 03/14/2021): EXTREME fatigue/exhaustion; sleeping 5-6 hours during the day Daily... Read more
After Dose 1 (given 03/14/2021): EXTREME fatigue/exhaustion; sleeping 5-6 hours during the day Daily migraine-like headaches Brain Fog Memory Loss After Dose 2 (given 4/11/2021): EXTREME fatigue/exhaustion; sleeping 3-4 hours during the day Frequent headaches Brain Fog Memory Loss Joint Pain Extreme Lower Back Pain Numbness and tingling in arms and hands One bout of paralyzation for 6-7 hours (seen in ER)
41 2021-06-16 migraine, feeling cold severe chills; could not get warm; could go back to sleep; migraine; sweating; This is a spontaneous... Read more
severe chills; could not get warm; could go back to sleep; migraine; sweating; This is a spontaneous report received from a contactable consumer (patient). This 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number unknown) as second single dose, in left arm, on 17Mar2021 at 12:30 PM (at 41 years of age), for COVID-19 immunisation. The patient's past medical history included obesity. The first single dose of BNT162B2 vaccine was administered in left arm on 22Feb2021 at 12:30 (at the age of 41 years), for COVID-19 immunisation. Concomitant medications included fluoxetine hydrochloride (PROZAC) and levothyroxine (unknown manufacturer). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19 and since the vaccination, she had not tested positive for COVID-19. On 18Mar2021 at 04:30,16 hours after the second dose, the patient woke up with severe chills, could not get warm or go back to sleep and woke up several hours later sweating and had a migraine from 04:30 till about 14:00. The patient did not receive any treatment for the adverse events. The events resolved on an unspecified date in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: age at vaccination added, age for historical vaccine added, Vaccine Facility Information added, Treatment Received selected as no, onset time updated in narrative to 04:30, coding additional events "could not get warm or go back to sleep". No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-06-16 pain in extremity diagnosed with Shingles; tired and lethargic; blood pressure was significantly high; has a little so... Read more
diagnosed with Shingles; tired and lethargic; blood pressure was significantly high; has a little soreness under the arm pits on both sides; mark on the back, size of a dime; looked like a bruise; itching in her back; tired and lethargic; little soreness in arm/having shooting pain up her arm; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 06May2021 (Batch/Lot Number: EW0182) as 1st dose, single dose for covid-19 immunization.Medical history included Fibroids (Has had one surgery), She knows she does have them again. She has some existing in her body, chicken pox (when she was really young and has never had a flare up). She has Rh negative blood.Concomitant medications included turmeric [curcuma longa rhizome] (TURMERIC [CURCUMA LONGA RHIZOME]) taken as vitamin, vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken as vitamin d supplementation, vitamin E nos (VITAMIN E NOS) taken as vitamin e supplementation, silybum marianum (MILK THISTLE) taken as vitamin supplementation, fish oil (FISH OIL) taken as vitamin supplementation and melatonin (MELATONIN) for helping with sleep.There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available).Family Medical History Relevant to AE included hypertension runs on both sides of her family. Diabetes on her dad's side. Her grandmother had Diabetes and her half sister tested Pre Diabetic a few years ago but changed with diet and exercise.It was reported that patient got the Pfizer covid 19 vaccine shot on 06May2021 waited the 15 minutes and had no side effects right then and there. She went about her day and went to work. On 06May2021, after patient got home from work she experienced little soreness in arm. on Friday, she had energy but was a little tired and lethargic went to bed early Friday and Saturday. She woke up really early 09May2021 (Sunday), with itching in her back. She thought it was a pimple or like something was itching in her back like a mosquito bite or something. She rubbed it a little then went back to sleep, woke up the next day, and at that time, it was the size of a dime. She had a mark on her back that looked like a bruise. She thought maybe she bitten by something. She did not think anything of it. She put hydrocortisone on it. The Sunday morning. She left it alone. She was still a little tired over the weekend. On 10May2021 (monday), she went to work and while she was typing, she started having shooting pain up her arm, on just the right side of her body. She got the shot in the left arm. She didn't know and didn't put anything together. She kept getting the shooting pain and had to take a break. When she started typing, she had the shooting pain again. It happened 5 times. She was usually very healthy. She does have fibroids and lives with that all the time. She works out and tries not to eat unhealthy.She decided to go to the ER and went right in the ER right away. She told them about the weird mark on her back. They told her they thought it was shingles. They did some tests, took a urine sample, blood sample, EKG (electrocardiogram) and checked her blood pressure, her blood pressure was significantly high. It has been typically low. Hypertension does run in her family. She is getting older but it has been typically low. She has a very stressful job, she knows that and high blood pressure was really shocking to her. They diagnosed her right away, told her they were pretty sure it was shingles. She had the chicken pox when she was really young and has never had a flare up. She felt fine until she got the covid shot.Does not know if it is related. She honestly thinks it was related.she was talking to some other people. She had shared with one of her board members that she had shingles and she said that someone she knew had the same reaction after the Covid shot. Was unsure if it was the Pfizer or the Moderna. Another friend of hers who is a nurse, encouraged her to call and report this. Looked online and saw that other people have gotten shingles after it triggered because the immune system was weak.She was pretty healthy and tries to work out. She didn't think anything of it. She has Rh negative blood. She hasn't gotten Covid that she knows of. She felt like she needed to do her civic duty.The patient was pretty healthy all of the time. Gets maybe a head cold, maybe once a year. Has never had the flu and hasn't even had the flu vaccine. The ER gave her 2 prescriptions for pain and no anti viral. She just took it upon herself to get some Calamine lotion to cover the mark on her back. She confirmed she was not admitted to the hospital. The patient was prescribed Hydrocodone and Gabapentin. Literally, that night, she went home and it started. That night was the worst night. She was fine for the most part. Now has a little soreness under the arm pits on both sides. The scabs are kind of healing with the Calamine lotion. She is just a little tired again today. She had a lot of energy yesterday and today a little bit lower in regards to energy. In the morning she started having pain, she went to the Emergency room. Before that, she took an allergy pill because of the season there and 2 Ibuprofen. The allergy pill was a generic off brand. The patient usually takes allergy pills because it is that time of year. Her eyes water quite a bit. She just takes it so she can get on with her day. She works quite a bit with the public. She has not gotten Covid, that she knows of. The patient was thinking about not getting it because of her blood type. She has seen that they are less susceptible and don't get symptoms as bad because of her blood type. Was going to wait a while but decided to just go and get it. Kind of felt like it was her duty. Takes vitamins quite a bit. Was really consistent a few months ago but has not been consistent. That might have attributed to it. At night, she does consume marijuana edibles. They gave her a read out of her blood. They did a whole list of stuff on her blood. They told her she should probably see a doctor for the blood pressure. It runs in her family in both sides. Has always knows that it runs in her family. This is her first time having high blood pressure. The Outcome of the events was unknown. No follow-up attempts are needed. No further information expected.
41 2021-06-16 pain in extremity My whole thighs is hurting; I couldn't move my arm for 2 days, it was stiff I couldn't move my hand;... Read more
My whole thighs is hurting; I couldn't move my arm for 2 days, it was stiff I couldn't move my hand; Joint discomfort and inflammation; Joint discomfort and inflammation; Even inhaling, exhaling is not comfortable; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0179), via an unspecified route of administration on 03Jun2021 (at the age of 41-year-old) at single dose for COVID-19 immunization. The patient medical history included blood pressure high, asthma, diabetes and vertigo. The patient concomitant medications included amlodipine besilate (AMLODIPIN (BESILAT) DEXCEL) taken for blood pressure high, metformin taken for diabetes, atenolol, olmesartan taken for blood pressure, cinnarizine taken for vertigo and diazepam (VALIUM). Patient did not receive any other vaccine prior to Covid vaccine. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0162), via an unspecified route of administration, administered at arm right on 13May2021 (at the age of 41-year-old) as single dose for COVID-19 immunization. The patient experienced my whole thighs is hurting, I couldn't move my arm for 2 days, it was stiff I couldn't move my hand, joint discomfort and inflammation on an unspecified date. On 04Jun2021, the patient had whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely, even inhaling, exhaling is not comfortable. Patient stated, I think I am having some kind of reaction with the shot (COVID-19 vaccine) because my whole entire body from my knee up to my neck is swollen. My whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely. Even inhaling, exhaling is not comfortable. Patient further stated, the next day the middle of the day almost every day my right arm started swelling up and next day my neck started swelling up. My whole thighs was hurting and was swollen. When I take vaccine I dont take any other medication, so I am not sure what is actually causing any problems. I havent taken anything else other than Tylenol. So, first time I didnt take anything I just took Tylenol but my arm swell up the same day. I couldn't move my arm for 2 days, it was stiff I couldn't move my hand. I put some heating pad and ice pad like stuff on it and about on the third day it started to get better but then 2 days after that I woke up swollen and I couldnt move. This was freaking me out. Under my arm and all the way down I don't think it should swell up like that and it is on whole body. The patient underwent lab tests and procedures which included TSH was unknown on 22Apr2021. The patient received Tylenol as a treatment medication for relief joint discomfort and inflammation. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
41 2021-06-16 tremor Nausea; Diarrhea; vaccination site redness/swelling; Muscle aches; Pain; Jaw tightness; Eye pain; Si... Read more
Nausea; Diarrhea; vaccination site redness/swelling; Muscle aches; Pain; Jaw tightness; Eye pain; Sinus pain; Congestion; Chest tightness; runny eyes; tight shoulder/neck; Fever; injection site redness/swelling,; jaw tightness and pain; Headache; Dizziness; Tremors; This is a spontaneous report received from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 14March2021 at 14:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, overweight and penicillin allergy eliminated in 2019. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), desloratadine (MANUFACTURER UNKNOWN), all for unknown indication from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 21Feb2021 at 17:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 15Mar2021 at 02:30, 12 hours post through 36 hours post, the patient experienced severe headache, dizziness, tremors, surges felt head to toe or vibrations and fever for 2 hours up to 102-102.8. On 15Mar2021 at 18:15, 28 hours post dose, the patient experienced nausea, diarrhea, injection site redness/swelling, pain and muscle aches, jaw tightness and pain, eye pain, sinus pain, congestion, dizziness, chest tightness, runny eyes and tight shoulder or neck. The patient received treatment for the adverse events and was treated with acetaminophen (MANUFACTURER UNKNOWN). The clinical outcome of the event fever was recovered on 15Mar2021 and headache, dizziness, tremor, nausea, diarrhea, vaccination site swelling, vaccination site erythema, pain, muscle aches, jaw tightness, jaw pain, eye pain, sinus pain, sinus congestion, chest tightness, watery eyes, neck tightness was recovering. No follow-up attempts are needed. No further information is expected.
41 2021-06-17 muscle spasms I got my 2nd Pfizer vaccination on 3/20/21 and had a positive pregnancy test on 3/21/21. Estimated ... Read more
I got my 2nd Pfizer vaccination on 3/20/21 and had a positive pregnancy test on 3/21/21. Estimated due date of 11/25/21. I started bleeding on 4/8/21 and went to the emergency room where they saw an embryo with a slow heartbeat. The bleeding continued and I went to see Dr. on Friday 4/9/21 and an ultrasound was performed where an embryo was seen with a slow heartbeat. The bleeding increased and I went back to the ER on Saturday, where they took my HCG and it had not doubled. It went up by a few points only. By Sunday, I was bleeding heavily and cramping. Monday, I went back to my OBGYN where they conducted an ultrasound to determine that I had miscarried.
41 2021-06-17 pain in extremity the first shot only thing I had with the first shot was a sore arm; the first one or the second one ... Read more
the first shot only thing I had with the first shot was a sore arm; the first one or the second one I had allergic reaction to; first shot was a sore arm and next day right in the area where the injection site was; This is spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in arm left on 20Mar2021 (age at the time of vaccination is 41-year-old) as single dose for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included triamterene (TRIAMTERENE) taken at 37.5mg; hydrochlorothiazide (HCTZ) taken at 25mg, once daily; methylprednisolone (METHYLPREDNISOLONE) all the concomitant medications are taken for an unspecified indication, start and stop date were not reported. It was reported that with the first shot only thing she had with the first shot was a sore arm and next day right in the area where the injection site and the first one or the second one she had allergic reaction to. Outcome of the events was unknown. No Follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021467210 same patient/drug, different vaccine dose/AE
41 2021-06-17 speech disorder Difficulty breathing; joint pain; headache; chills; nausea; diarrhea; body ache; hives; my throat st... Read more
Difficulty breathing; joint pain; headache; chills; nausea; diarrhea; body ache; hives; my throat started to close down it was very hard to breathe; I could barely talk; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0161) on 08Apr2021 at 13:00 (at the age of 41 years), as first single dose, in left arm, for COVID-19 immunization. Medical history included penicillin allergy, latex allergy and peach, papaya allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levocetirizine dihydrochloride (XYZAL) pro air inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09May2021 at 14:00 the patient experience difficulty breathing, joint pain, headache, chills, nausea, diarrhea, body ache, hives, her throat started to close down, it was very hard to breathe and she could barely talk. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included allergy medication, another inhaler and epinephrine (EPIPEN). The events were resolving. Since the vaccination, the patient had not been tested for COVID-19.
41 2021-06-17 tenderness Elbow bursitis. So painful I drove myself to the hospital. Prednisone mostly cleared it up in a few ... Read more
Elbow bursitis. So painful I drove myself to the hospital. Prednisone mostly cleared it up in a few days, but my elbow is still tender more than a month later. My activity and age do not make this a likely health issue for me.
41 2021-06-18 breast pain Swollen lymph nodes under left arm making left breast sore; Swollen lymph nodes under left arm makin... Read more
Swollen lymph nodes under left arm making left breast sore; Swollen lymph nodes under left arm making left breast sore; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration in left arm on 02Mar2021 (Batch/Lot Number: EL3247), at 41 years of age, as single dose for COVID-19 immunization. Medical history was none. The patient didn't receive any concomitant medication and any other vaccine in the previous 4 weeks, she was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On an unspecified date in Mar2021 the patient experienced swollen lymph nodes under left arm making left breast sore. The patient didn't receive any treatment for the events. At the time of the report the events had not resolved yet. No follow-up attempts are needed. No further information is expected.
41 2021-06-19 discomfort I had my 2nd vaccine on 4/5 @ 4:30pm. I felt slightly tired afterwards and noticed that I couldn't s... Read more
I had my 2nd vaccine on 4/5 @ 4:30pm. I felt slightly tired afterwards and noticed that I couldn't stop yawning. After getting home, I ate dinner and went to bed at around 9pm. At around 2:30am, I woke up feeling an intense heaviness on my chest as if something was sitting on top of me and crushing my upper chest. I stood up and had to immediately crouch over due to the intensity of the pain and heaviness. My husband had to hold me up and suggested going to the hospital. I was terrified and just wanted to wait and catch my breath. It was hard to believe what was happening and I did not want to go to the hospital. After about 5 mins, the intensity of the pain subsided and I was able to breathe normally. I was able to go back to sleep with minor discomfort and woke up at around 6am without any symptoms. About 2 weeks later, I started to have chest pain, which I had never experienced before. I tried to attribute it to all sorts of things, but it didn't go away so on 5/1, I went to City MD to have an EKG and chest X Ray. Both came out normal and they told me to follow up with a cardiologist for due diligence. I followed up with a cardiologist and they also ran an EKG and X Ray with normal results. Depsite normal results, I thought it was important to report this because I am a healthy and fit 42 year old with no prior heart history and found it uncanny that I had my first "heart event" within 12 hours of my 2nd vaccine.
41 2021-06-19 numbness, tingling, cold extremities I received the first dose of the Covid Pfizer vaccine on Wednesday, June 16 at around 6:45pm. By 9:... Read more
I received the first dose of the Covid Pfizer vaccine on Wednesday, June 16 at around 6:45pm. By 9:30 pm I started to notice my feet felt very cold and numbing sensation that felt as though my feet were in a puddle of water. I then had a low-grade fever and the numbing tingling sensation started to travel up my legs. By 2am my tongue and mouth started to tingle. by morning my feet still felt cold/numb, my tongue/mouth tingled and then my hands started to feel the same. As the day progressed I noticed the same sensation on my forearms and occasional sharp pokes across my face. It has been 4 days since the vaccine and I continue to feel the tingling sensation throughout my body. The cold numbing feeling I had in my feet has subsided some but I still feel in other parts of my body like legs, chest, mouth, face and hands. I have made my primary care dr, rheumatologist and pharmacy where I received the vaccine aware. I had not experienced this prior to the vaccine.
41 2021-06-19 seizure Daughter suffered 3 "auras". She also seized during those auras. Neurologist stated the vaccine coul... Read more
Daughter suffered 3 "auras". She also seized during those auras. Neurologist stated the vaccine could have had an adverse effect. She reported after 2nd injection that she felt somewhat dizzy. She spent overnight in the observation wing of the hospital. She also received an EEG. Her meds will be increased. It is highly probable that the vaccine had an adverse effect on her.
41 2021-06-19 seizure 06/17/21 - Patient's mother stated patient was little off the night of. 06/19/21 - Patient was admi... Read more
06/17/21 - Patient's mother stated patient was little off the night of. 06/19/21 - Patient was admitted to hospital for at least 3 seizures.
41 2021-06-20 muscle twitching Muscle twitching, Vertigo a week later, Dizziness for weeks, Treatment: Steroids & Meclizine, I am s... Read more
Muscle twitching, Vertigo a week later, Dizziness for weeks, Treatment: Steroids & Meclizine, I am still experiencing muscle twitching in different parts of my body and it occurs at random moments.
41 2021-06-20 tremor, migraine, pain in extremity 9 hours after receiving my first dose I had severe chest pains. tremors, insomnia, migraine headache... Read more
9 hours after receiving my first dose I had severe chest pains. tremors, insomnia, migraine headaches. The symptoms lessened after the first 3 days but still come back randomly and are now becoming constant again- constant chest pains, dizziness, shortness of breath and fatigue. Pain is radiating down my left arm and legs as well. I have notified my cardiologist and will be requesting further evaluation of side effects.
41 2021-06-21 tingling, burning sensation, muscle spasms, sensory loss, numbness Timeline: 4/22: Pfizer Dose 2 Covid Vaccine; 5/11: L wrist dropped and numb, all L fingers unable to... Read more
Timeline: 4/22: Pfizer Dose 2 Covid Vaccine; 5/11: L wrist dropped and numb, all L fingers unable to lift and numb; 5/14: toes burning (felt on fire) and itching, legs felt odd w/ pins and needles spasms and cramps; 5/17: became aware of lack of sensation in legs/feet at physician office; 5/20: ER visit b/c R fingers paralysis began and lightheaded--scared. MRI's performed--no tumors or lesions from notes; 5/24: EMG. Nothing notable. Too soon as Neuro indicated. Neuro Disinterested in anything other than left arm as I expressed; 6/3: Consult with. Last communication as follows: 6/11/2021: Hi mam, I would not do it earlier than the last week of June for a more accurate study. Also, in regards to the vaccination- unfortunately, there is no way to confirm whether it definitely did or didn't play a role, but you may be right and that it is part of this picture for you. Unfortunately, we are at a place right now where the medical community is still learning about the potential side effects since it is a new vaccination. We don't yet know exactly how long after the vaccination we can expect side effects to occur and how long they are expected to last. The good news is that it doesn't alter your treatment course either way. The same holds true for those that suffer from headaches after the vaccination or even covid-19 infection. The headaches are treated the same as regular tension headaches/migraines. If there is a component of a vaccine side effect we do expect time to help heal that as well, but I would definitely continue with our plan to proceed with the nerve study, PT, and avoiding positions that cause nerve compression. Sincerely, PA-C On 6/7/2021 Physician also wrote: Guillain Barre Syndrome can happen after vaccinations and is something that I did consider for you. I do not think that your symptoms and exam align too well with it though. The "text book" or "hallmark" presentation is ascending weakness, numbness, and tingling. It typically starts in the feet and can work its way all the way up to the hands and respiratory muscles. The pattern of your symptoms is not quite consistent with this.
41 2021-06-22 discomfort dizziness, headache, heaviness at back of head and neck, difficulty concentrating
41 2021-06-22 muscle spasms This is a spontaneous report from a contactable Other HCP (patient). A 41-years-old female patient r... Read more
This is a spontaneous report from a contactable Other HCP (patient). A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 at the age of 41-years-old (Lot Number: ER8731) as single dose for COVID-19 immunization. Relevant medical history and concurrent conditions was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took amoxicillin and experienced Known allergies: Amoxicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported: "I broke out in a rash on 17Apr2021. It started on my face in a straight line down my left cheek and neck. Then it appeared in patches on my trunk (both stomach and back). It eventually spread to my legs. I got new patches for 2 weeks following the shot. I went to the doctor and they couldn't prescribe steroids as it was stated that it would lesson the effects of the second shot. When I started my menstrual cycle 3 weeks following the 1st dose of my Pfizer shot I had severe cramping and clotting for 3 days during my period. It was the most pain that I have had from a period. The flow was stronger from the beginning of the cycle than is typical." The adverse event result in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in 2021.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that th event rash is related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-06-22 pain in extremity Initially I had arm pain, as expected later in the evening on day of shot. I iced and took Tylenol ... Read more
Initially I had arm pain, as expected later in the evening on day of shot. I iced and took Tylenol as advised by staff at health department. Saturday morning I woke to nausea, lightheadedness and increased arm pain. I pushed fluid intake, rested off and on all day, took Tylenol as needed. Sunday morning felt tired, but other symptoms were better so went about the day. Sunday afternoon I noticed my joints started hurting, and chills set in. By Monday morning every joint in my body hurt, and not just an ache - because all of my muscles were aching as well - but my toes, ankles, knees, elbows, hips felt like they had been hammered and were throbbing. I've been taking Tylenol, resting, fluids as tolerated and three days from onset it's still hanging on. I've never experienced joint pain like this in my life ...
41 2021-06-23 weakness, tremor Within a few minutes of the shot I had difficulty breathing, swallowing, my throat felt like it was ... Read more
Within a few minutes of the shot I had difficulty breathing, swallowing, my throat felt like it was closing up, and I had chest pain. I was incredibly shaky and had to be monitored by the paramedics and receive oxygen for almost 1.5 hours. In the following days I experienced extreme fatigue, muscle soreness, fever, loss of energy, severe headache. It took me about a month to fully recover and feel well again.
41 2021-06-23 flushing face turned flushed; taste of metal; elevated blood pressure; tachycardia; hypertension; Allergic re... Read more
face turned flushed; taste of metal; elevated blood pressure; tachycardia; hypertension; Allergic reaction; vomiting; rash on face; itchy throat; This is a spontaneous report from a contactable physician (patient herself). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EH9899), via intramuscular route, administered in left arm on 21Dec2020 16:33 (age at vaccination: 41-year-old) as 1st dose, single dose, for COVID-19 immunization. The vaccine was administered in a hospital. The patient's medical history included on an unknown date in 1979, anaphylactic reaction after general anaesthesia due to which the patient was in coma for 7-days; On an unknown date in 2016, tachycardia after Lidocaine inj. topical injection causing short of breath, hypotension; shortness of breath after Benzocaine topical during a dentist procedure causing short of breath, vomiting, wheezing; From 2012, the patient was allergic to yellow jacket, vispid, bee and seafood. Concomitant medication(s) included levothyroxine sodium taken for hypothyroidism from 07Aug2018 at a dose of 50mcg daily. On 21Dec2020 16:42, 9 minutes after the vaccine, the patient experienced vomiting, rash on face, tachycardia, hypertension, itchy throat, taste of metal. On an unknown date, the patient's face turned flushed and elevated blood pressure. The events of vomiting, rash, tachycardia, hypertension and throat irritation were considered to be medically significant. The patient reported that he got an allergic reaction to the first dose first dose of the vaccine and his allergist does not want him to get the 2nd dose. The patient was taken to the emergency room due to the event and was treated with Epinephrine SC was given, IV decadron and famotidine given oral loratadine (due to allergy to beta drugs), IV fluid was started. The patient was discharged from emergency room 4 hours later. Tachycardia lasted for 24 hours. The patient underwent antibody test on an unknown date for which the results were unknown; ON 21Dec2020, the patient's histamine level was normal and tryptase test (done 1 hour after event) was also normal. The patient was not deceased. The outcome of the event dysgeusia, flushing and blood pressure increase were unknown, and all the other events were recovered on 22Dec2020. Reporter considerd the Pfizer product had a casual effect to the adverse event. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of rash,throat irritation,flushing,tachycardia.But also consider relevant medical history of anaphylaxis,allergic history and concomitant medications . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-06-24 burning sensation Tachycardia heart rate 135 bpm at rest; shortness of breath oxygen saturation 90%; Chest tightness; ... Read more
Tachycardia heart rate 135 bpm at rest; shortness of breath oxygen saturation 90%; Chest tightness; burning; This is a spontaneous report from a contactable other hcp/nurse (patient). A 41-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EK9231 and expiry date: unknown), dose 1 via intramuscular, administered in Arm Right on 13Jan2021 14:30 as SINGLE DOSE for covid-19 immunisation. Medical history included female pattern hair loss. The patient previously took clindamycin and experienced drug hypersensitivity, compazine [prochlorperazine edisylate] and experienced drug hypersensitivity. Prior to vaccination, the patient was diagnosed with COVID-19. Patient not tested covid post vaccination. No other vaccines were received within 4 weeks prior to the COVID vaccine. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), montelukast sodium (SINGULAIR), vitamin d3 (VITAMIN D3), folic acid (VITAMIN B12 & FOLIC ACID) and finasteride (FINASTERIDE). The patient experienced tachycardia heart rate 135 bpm at rest, shortness of breath oxygen saturation 90%, Chest tightness and burning on 13Jan2021 23:45. The patient underwent lab tests and procedures which included heart rate: 135 bpm at rest on an unknown date, oxygen saturation: 90 % on an unknown date. No treatment received for the events. Outcome of all the events was recovered with lasting effects. Follow-up (14May2021): Follow-up attempts completed. No further information expected.
41 2021-06-24 feeling of body temperature change, muscle spasms, numbness, feeling hot, facial paralysis On September 26, 2017, four days before having my third baby by cesarean section, I had facial paral... Read more
On September 26, 2017, four days before having my third baby by cesarean section, I had facial paralysis, which culminated the following month, without noticeable scars on the face, but yes, some sensitivity to cold or sudden changes in temperature . After applying the vaccine, I felt slight body heat and they warned us that we were going to have pain in the arm and possibly cramps, no more. But, the day after the application, I began to feel the flu, cough, muscle pain, slight headache, but on the fourth day of the application, the flu had almost disappeared and I began to feel the same sensation in my body as when I had facial paralysis, I have two fingers slightly numb on my left hand and one finger from my right hand, cramps in my face. My question is what should I do in this case? Do I apply a second dose, can I cancel, what consequences will I have if I apply the second. I know that apparently nobody forces you, but if you have family in another part of the world, you will NEVER be able to see them again, because it is mandatory to go but vaccinated, in fact while they administered it to me, and before applying it, I thought I HAD BEEN SOLD ON IT TOO EASILY, I WANT TO SAY I AGREED BECAUSE I DIDN'T WANT TO STOP SEEING MY FAMILY, but now I think that if something happens to me thanks to this vaccine, I may not be able to see them for a long time or ever.
41 2021-06-24 pain in extremity Itching and hives; Itching and hives; Muscle aches; Arm soreness; Fatigue; This is a spontaneous rep... Read more
Itching and hives; Itching and hives; Muscle aches; Arm soreness; Fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, in left arm on 29Apr2021 14:30 as single for COVID-19 immunisation. Medical history included of chronic autoimmune hives likely exacerbated by COVID vaccine, limited occurrence of hives since stopping oral contraceptive in Nov2020 and recent urinary tract infection (UTI). No allergies reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: L3247) via intramuscular route of administration, administered in arm left on 08Apr2021 at 12:30 (at the age of 41-year-old) as single dose for COVID-19 immunization. Concomitant medications included within 2 weeks of vaccination ascorbic acid, calcium phosphate, lactobacillus, vaccinium macrocarpon (AZO CRANBERRY), menotrophin (MENOPUR), follitropin beta (FOLLISTIM), nitrofurantoin and MVI (MULTIVITAMINS) all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 29Apr2021, patient experienced arm soreness, fatigue and muscle aches on 30Apr2021. On 02May2021 01:00 the patient experienced itching and hives present on trunk, gluteal region, arms, legs, and scalp 3 days after second vaccine dose. The patient received treatment for the events was Zyrtec. The outcome of the events itching, and hives was not recovered and for all other events was unknown. No follow-up attempts are needed. No further information is expected.
41 2021-06-24 pain in extremity The next morning the patient woke up with a large ball under her axillae (likely enlarged lymph node... Read more
The next morning the patient woke up with a large ball under her axillae (likely enlarged lymph node) she states it was very large; she states it lasted 10 days and was very painful
41 2021-06-24 pain in extremity Major pain in arm; chills off and on; This is a spontaneous report received from a contactable consu... Read more
Major pain in arm; chills off and on; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 04May2021 at 18:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not take any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 13:00, the patient experienced major pain in arm and chills off and on. The clinical outcome of the events major pain in arm and chills off and on was not recovered at the time of reporting. No follow up attempts are possible. No further information is expected.
41 2021-06-24 tingling, flushing, numbness A numb/tingling feeling on the left side of my face; A numb/tingling feeling on the left side of my ... Read more
A numb/tingling feeling on the left side of my face; A numb/tingling feeling on the left side of my face; Tingling sensation in both cheeks; My face feeling/looking flush that night; This is a spontaneous report from a contactable other hcp (Patient). A 41-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 01Feb2021 15:45 (age at vaccination: 41-year-old) as single dose for an covid-19 immunization. Medical history included graves disease in remission. There were no concomitant medications. The patient previously took amoxicillin and experienced drug allergies. Patient not tested covid prior and post of vaccination. It was reported that patient experienced Tingling sensation in both cheeks while drive home (approximately 30 minutes after shot). Went away after a few minutes but left her face was feeling/looking flush that night. About 24 hours on 02Feb2021 later she was developed a numb/tingling feeling on the left side of her face. This feeling continued so called her Drs office on 03Feb2021 to let them know. They told if symptoms worsened she should go to the ER. She woke up on 04Feb2021 and the feeling had gone away, but returned in the afternoon and persisted. Woke up this morning 05Feb2021 and the feeling was gone but returned by 10 am and is still persisting. The outcome for the events was not resolved. Follow-up attempts are completed. No further information is expected.
41 2021-06-24 cold extremities, slurring Dose 1: slurring speech, confusion, sweating, rapid heart beat, chest pain Dose 2: Mydriasis in bo... Read more
Dose 1: slurring speech, confusion, sweating, rapid heart beat, chest pain Dose 2: Mydriasis in both eyes, rapid heart beat, oxygen sat lower than my normal, cold hands and feet, under eye swelling
41 2021-06-25 involuntary muscle movements, numbness The patient described the following adverse reaction to her first Pfizer dose. Swelling of left arm ... Read more
The patient described the following adverse reaction to her first Pfizer dose. Swelling of left arm up to neck and down the lefts side of back with pain, throbbing, and numbness. She had severe back and arm pain for 3 weeks. Her gait and movement were impacted. She reported a headache that lasted four days that was focal behind her left eye. 8 weeks post-injection, she still has numbness and some aching pain in her back and neck. She sought care at a doctor's office.
41 2021-06-25 pain in extremity After the 1st shot, I had the usual sore arm and swelling. In the next few days, there was a large a... Read more
After the 1st shot, I had the usual sore arm and swelling. In the next few days, there was a large amount of swelling on the right side. Pain at the injection site, lymph swelling. It stayed pretty constant and I did my best to move my arm and use ice to combat the pain. For my second shot, I was still experiencing pain on the right side so I asked to have it in the left. I reacted with the typical low-grade fever and aches. I had some slight swelling on the left side but it went away in about 24 hours. Within that week the right side axillary area swelled up and pain got worse. My breast became very swollen too.
41 2021-06-25 unresponsive to stimuli When walking from vaccination area to observation area she passed out and hit the back of her head o... Read more
When walking from vaccination area to observation area she passed out and hit the back of her head on the floor Her husband, was with her and was able to provide information that she got lightheaded after her first shot, as well, but did not pass out. On initial evaluation, she was not responsive. BP 180/100, HR ~65 Legs were elevated and she slowly started to regain consciousness. She complained of pain in the back of her head EMS was called due to head trauma She was placed in a C-collar and taken via ambulance to ED for further evaluation
41 2021-06-27 feeling hot Heart palpation, heart flutters, pain general discomfort in chest/heart, warm sensation in chest
41 2021-06-28 pain in extremity Shoulder / arm pain began about 36 hrs after the initial vaccine. Couldn't lay on my left arm but as... Read more
Shoulder / arm pain began about 36 hrs after the initial vaccine. Couldn't lay on my left arm but assumed it would go away. Received second vaccine 6/7/2021 by same clinic and it's gotten progressively worse. Can't sleep & difficulty working Reduced range of motion. Constant pain from shoulder down nearly to the wrist. Dr diagnosed as SIRVA. Prescribed steroid pack and physical therapy. Steroids have not provided any relief. Next suggestion is cortisone shot. Dr said it may never get better.
41 2021-06-28 tenderness The lymph nodes behind both of my ears became so swollen and painful to the touch that I couldn?t we... Read more
The lymph nodes behind both of my ears became so swollen and painful to the touch that I couldn?t wear my eyeglasses for a week. After that went away, my spleen became tender and sore for approximately three days. Since getting the vaccine, I have episodes of dizziness and feel lightheaded frequently (a couple times per day). My periods were almost non-existent prior to the vaccine and now they?re very heavy and last a week or longer.
41 2021-06-29 hot flush Dizziness; Hot flashes; Diarrhea; This is a spontaneous report received from a consumer, the patient... Read more
Dizziness; Hot flashes; Diarrhea; This is a spontaneous report received from a consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH6208), via an unspecified route administration in the left arm on 19Mar2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Concomitant medication included TYLENOL for an unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 10:30, the patient experienced dizziness, hot flashes and diarrhea (after two hours of vaccine administration and lasted for several hours). The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events dizziness, hot flashes and diarrhea was resolved on an unspecified date in Mar2021. No follow-up attempts are needed. No further information was expected.
41 2021-06-29 numbness Partial facial numbness near and around my left eye and cheek; This is a spontaneous report received... Read more
Partial facial numbness near and around my left eye and cheek; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6207) via an unspecified route of administration in right arm on 19Mar2021 at 11:15 (age at vaccination 41-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and gastroesophageal reflux disease (GERD). Concomitant medications included fexofenadine hydrochloride (ALLEGRA) and famotidine (MANUFACTURER UNKNOWN) both for unknown indication, from unknown date. The patient was allergic to amoxicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 19Mar2021 at 15:00, the patient experienced partial facial numbness near and around her left eye and cheek. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported event numbness facial. The clinical outcome of the event numbness facial was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2021-06-30 migraine Single migraine starting 5/6/21 that did not go away for weeks, varying in severity from 3 to 8 (out... Read more
Single migraine starting 5/6/21 that did not go away for weeks, varying in severity from 3 to 8 (out of 10). Ibuprofen helped dull the pain, but it never fully dissipated. On 5/27/21, I had an urgent tele-health appointment and was prescribed Prednisone 50mg for 7 days and Hydrocodone. Neither helped. On 6/4/21, I went to urgent care. A CT Scan was done and came back normal. I was prescribed 50mg Sumatriptan. It didn't help. On 6/11/21, I had an appointment with my primary care doctor and she prescribed 25mg Metoprolol twice a day. My migraine was gone 3 days later. On 6/23/21, my Metoprolol was lowered to 25mg once a day. On 6/30/21, I stopped taking Metoprolol. My headache has not returned. When I initially met with my PCP, she knew exactly what had caused my migraine and how to treat it. Unfortunately, it's very difficult to get appointments with doctors without a long wait.
41 2021-06-30 tingling, feeling hot, flushing, numbness I did have diarrhea the next morning; Panic attack; It was a near fainting episode; It was a near fa... Read more
I did have diarrhea the next morning; Panic attack; It was a near fainting episode; It was a near fainting episode; Feel a flush go through my chest and then up through my face; I had an antiseptic taste in my mouth; feel hot all over; Sweating beads of sweat on my forehead running down; Suddenly my hearing went muffled almost completely out; Heart was also racing; Felt very lightheaded and dizzy; My hands and fingertips were tingling and felt numb; My hands and fingertips were tingling and felt numb; I had extreme arm soreness on the arm with the injection; I felt extremely tired and sluggish for the rest of the evening; I felt extremely tired and sluggish for the rest of the evening; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0191 and Expiration date: unknown), via an unspecified route of administration, in left arm on 15Jun2021 at 15:00 (at the age of 41-years-old) as dose 1, single for covid-19 immunisation. Medical history included PCOS and thyroid nodules from an unknown date. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken for oral contraception, start and stop date were not reported. The patient previously took erythromycin. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 15Jun2021 at 15:00, within about 30 seconds of receiving the vaccine she could feel a flush go through her chest and then up through her face. She had an antiseptic taste in her mouth. She began to feel hot all over, started sweating beads of sweat on her forehead running down, suddenly her hearing went muffled almost completely out, heart was also racing and felt very lightheaded and dizzy. She had to lean back in the chair and close her eyes for about 15 minutes until it stopped. Afterwards when she got up to leave, still felt dizzy and her hands and fingertips were tingling and felt numb. Either this was a panic attack or it was a near fainting episode. Afterwards she had extreme arm soreness on the arm with the injection. She felt extremely tired and sluggish for the rest of the evening. The next day (as reported) she felt better, just a little sluggish with arm soreness. On 16Jun2021 the patient experienced that, she did have diarrhea the next morning which was not normal for her. Hospitalization was not required for events. No treatment was received for events. Outcome of events was recovered on an unknown date in Jun2021.
41 2021-06-30 tenderness, pain in extremity Dizziness about 30 minutes after. Approximately 6 hours after the injection site turned red, very ... Read more
Dizziness about 30 minutes after. Approximately 6 hours after the injection site turned red, very swollen, very painful, difficult to lift and move arm and very sore to touch or apply pressure. Approximately 10 hours after the injection began having COVID symptoms with fever of 102.1, all over body aches, headache, nausea, very fatigued, dry mouth, itchy eyes and eye drainage, neck pain and tenderness on the left side and pain and swelling running up left arm into shoulders and neck. Also, my right arm was very sore and tender in the exact same spot as my left arm injection site. Pain in left jaw and teeth and right groin area. As of 26 hours later I have the same symptoms as listed above and my head feels very heavy like I can?t hold it up.
41 2021-06-30 tension headache Starting April 6 (date is best of my recollection but actual dates should be viewable in where I log... Read more
Starting April 6 (date is best of my recollection but actual dates should be viewable in where I logged everything) I experienced 3-4 consecutive days of ocular migraines each morning. I have had a few (1-3) ocular migraines in my life but very rarely and never more than once every few years. This was followed by reoccurring tension headaches that increased in frequency and duration until constant. Vertigo started a week or two later and continued daily until yesterday 6/30/21 when I saw a physical therapist who was able to perform the Epiley Maneuver for BPPV in my left ear canal. This is not something I have ever had before. I requested to see my doctor on Monday June 7th after two months of Vertigo and tension headaches that followed the ocular migraines. Symptoms themselves would have been manageable if temporary but the duration became concerning. I was prescribed and took a 5 day course of prednisone in case the headaches and resulting vertigo might have been related to a sinus infection. I was prescribed meclizine to help with the Vertigo and referred to PT.
41 2021-06-30 tremor, feeling hot, numbness, muscle spasms, pain in extremity, tingling, weakness Urine infection; anxiety attack; panic/anxiety attack; Her body started tingling and was numb; her b... Read more
Urine infection; anxiety attack; panic/anxiety attack; Her body started tingling and was numb; her body started tingling and was numb; The end of her hand cramped up; I don't know how to breathe/short of breath; whole body started shaking; Racing heart beat; Feels like throwing up; had a fever; She reports she began to feel tired/she was weary and tired; didn't feel well at all; body felt warm; Hands hurt; Felt chilled; stomach was tight; She might have respiratory alkalosis; She woke up hungry and weak; She woke up hungry and weak; Sleepy; This is a Spontaneous report from a contactable consumer (patient husband) reported for a patient (reporter's wife). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, in left arm on 08Jun2021 at 13:00 (at the age of 41-year-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing high cholesterol. She did not take a medicine for that. It was genetic and runs in her family. The patient's concomitant medications were not reported. No additional vaccines administered on same date of the pfizer suspect. The patient did not receive any vaccines within four weeks prior to the vaccination. Caller was a consumer calling on behalf of his wife. Patient was present for this call. She was having a serious side effect from the Pfizer Covid-19 Vaccine. Wife reported that she received the first dose of the Pfizer Covid-19 vaccine on 08Jun2021 Tuesday at 13:00. Wife reported was getting home around 15:00 and went to shower. At around 14:30 she started to feel tired and her body felt warm. She was really really tired and can't stand up. It started when she came home after the vaccine. She got hungry and started shaking and it was hard to breathe again. She reported, she began to feel tired, did not feel well at all, took a nap and also felt chilled. She stated she didn't check her temperature. She reported she thought she would feel better the next day, but she felt worse. She stated she checked her temperature and had a fever, so she took some Tylenol. She reported she still felt tired. She reported that last Friday (11Jun2021 at 10:30) in the morning when she woke up, she felt like she did not know how to breathe and my stomach was tight. On Friday 4 days later (on 11Jun2021) she developed shortness of breath, It was about the same. She used brown bags to inhale and exhale and they didn't work. Husband reported, his wife started to feel short of breath, her body started tingling and was numb It started last Friday 11Jun2021 morning at around 10:30, the end of her hand cramped up. Her two hands cramped. It happened 3 or 4 times which was why they called the ambulance. He stated that was serious and we had to call an ambulance. He reported that the medic came and checked her temperature and oxygen and said she had no problem, and it was an anxiety attack. Husband reported he did not know why she had this as she had never had before now. She has had no anxiety problems or mental problems in her life. The doctor said to breathe slowly and relax. The hand cramps happen 4 or 5 times a day, and she had to try relaxing a little bit. It will calm her body shaking but she still had shortness of breath. Husband reported that after the medic left, she was still feeling uncomfortable about an hour later and they went to urgent care where the doctor reported she might had respiratory alkalosis. Caller reported that the doctor didn't do any blood tests but gave her hydroxyzine 50 mg for allergies and maybe she had a panic/anxiety attack that put her to sleep. She went to sleep and felt better, but as soon as she woke up she would shake and the shortness of breath would came back. She woke up hungry and weak, and when she had some food she will feel a little better but was not breathing well. Husband stated that was okay for 2 days. He reported that on Saturday (12Jun2021), they went to family doctor for check-up. That doctor also thinks she had an anxiety attack and gave her anxiety medication alprazolam 2.25 mg and gave her something for heartbeat and also propranolol for a racing heartbeat. The hydroxyzine, alprazolam, and propranolol are in amber colored pharmacy bottles. Alprazolam expiration date was Feb2022, Propranolol expiration date was Sep2022. She saw the doctor today. She was taking that medicine for her heart. Husband stated a medicine to slow down heartbeat. Husband reported she had a severe attack Monday (14Jun2021) again and went to the ER. He reported the hospital gave her lab tests to check on body and physically everything looked okay to them. He reported they did x-ray of lungs and organs and nothing seems wrong. He stated seems weird. Husband reported they went to family doctor again today (16Jun2021) and took more medication. The doctor advised wife to go to a psychiatrist. Husband reported they went there, and psychiatrist did assessment and thinks she did not have psych problems as psych problems wont give her fever and she reportedly had 11 days of fever until now. He stated, it did not go away, no one can help her, they had anxiety pill on their hands but nothing was helping her breathing, they did not understand what causes this. Wife reported her whole body started shaking every morning when she woke up and sometimes in the afternoon she started shaking again and took anxiety medication. Husband asked why the doctor did not give her breathing medication? We had inhaler but it did not help. Earlier they went to saw psychiatrist and the psychiatrist asked them to call pfizer to guide them what to do. Husband states we went to 3 different physical doctors and went to psychiatrist and it's not psych problem, psych problem won't give fever. They went to different departments and they had no idea what to do. They want to find out more about it. They seek help from different doctors but they did not have solution. Wife reported her temperatures around 100.6F, 100.5F, 100.1F, and 99 something. Wife stated a lot of time it was 99 something. She had the fever again the next day on 09Jun2021. Last night her temperature was 100.4 or 100.5, and this morning it was 99 something. She had not taken Tylenol yet. She didn't feel good at all. She felt cold and then was hot the next day. She felt really tired and checked her temperature. Her fever had continued for 11 days now. She took Tylenol before bed and it brought it back to normal 98 or 97. She went to the hospital on Monday (on 16Jun2021) and they said she probably had a urine infection. Today the family doctor gave her some antibiotics. Her stomach felt tight when she started getting shortness of breath. It was tight like she didn't know how to breathe. She felt like throwing up sometimes. It started Friday. When she came back after the shot she was weary and tired, chilly, sleepy, and her hands hurt. Then she couldn't breathe. She stated they didn't go anywhere this whole year not even grocery store, they shop online. They only went in the backyard that's it. Her first time was to get vaccine. Caller's question was if these symptoms have been reported before and what should they do? He read the description on the product and none of that what she experienced. She went to her family doctor and to the ER. She went to so many different doctors and also a psychiatrist with no solution. His wife was experiencing shortness of breath and her whole body was shaking. He asked if Pfizer has heard anything about these side effects before. Reporter seriousness for events reported as unspecified. The events resulted in emergency room and physician office visit. Patient was not hospitalised. Outcome of events I don't know how to breathe/short of breath, whole body shaking, her body started tingling and was numb, The end of her hand cramped up, She reports she began to feel tired/she was weary and tired, didn't feel well at all, had a fever, racing heart beat, feels like throwing up, hands hurt, body felt warm was not recovered and outcome of other events was unknown. Information on the lot/batch number has been requested.
41 2021-07-01 weakness Chills; Fatigue; Nausea; Weakness; Headache; GI distress; This is a spontaneous report from a contac... Read more
Chills; Fatigue; Nausea; Weakness; Headache; GI distress; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 at 18:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included migraine, asthma, GERD, obesity. The patient was allergic to avocado, shellfish, penicillin. Concomitant medications included lansoprazole (MANUFACTURER UNKNOWN) , montelukast sodium (SINGULAIR), erenumab (AIMOVIG), nortriptyline (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: C1821), via an unspecified route of administration in the left arm on 24Feb2021 at 18:00, (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 21Mar2021 at 18:00, the patient experienced chills, fatigue, nausea, weakness, headache and GI distress. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events chills, fatigue, nausea, weakness, headache and distress gastrointestinal was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2021-07-01 tingling, facial paralysis, face paralysis On May 27, 2021 at 9:20am, I experienced drooping of the right side of my face, weakness in my right... Read more
On May 27, 2021 at 9:20am, I experienced drooping of the right side of my face, weakness in my right arm and leg, and right cheek, arm and leg paresthesias. I was taken to the ER where I was diagnosed as having a transient ischemic attack (TIA).
41 2021-07-02 migraine After the first vaccination shot (late April 2021), my menstrual cycle was fourteen days early. Afte... Read more
After the first vaccination shot (late April 2021), my menstrual cycle was fourteen days early. After the second vaccination shot, my menstrual cycle was later than usual, arriving at about Day 31 of my cycle. My cycle is typically 26 days long. The menstruation after my second shot was exceedingly heavy and painful - I had terrible cramps, worse than normal fatigue, and very heavy bleeding. The menstruation lasted longer than normal for me (about eight days), and it was followed by a few days of spotting, which is also unusual for me. In addition to these changes in my cycle, I experienced worse than normal migraines throughout the month of June, both during menstruation and during ovulation. I typically get migraines about once or twice a month, and I was getting migraines about 3-4 times a week throughout June.
41 2021-07-02 muscle spasms My right arm muscles are in spasm all the time and I can barely grip my right hand to pick up an obj... Read more
My right arm muscles are in spasm all the time and I can barely grip my right hand to pick up an object. I had no previous right arm difficulties.
41 2021-07-03 weakness About an hour after I got vaccinated, I started to go into anaphylactic shock. My throat started to ... Read more
About an hour after I got vaccinated, I started to go into anaphylactic shock. My throat started to close and I was having adrenaline rushes, heart rate instability, and dizziness. I felt very shaky and weak. I was able to reverse it with Benadryl and other antihistamines. I did not need my Epipen. My symptoms subsided after about 4-5 hours. I did not eat anything after getting the shot, and I was not exposed to any other allergen that could have caused an anaphylactic reaction. I have not started any new medications that could have caused this either. I believe my reaction was related to the vaccine.
41 2021-07-03 flushing Systemic: she just had an anxiety attack-Mild, Systemic: Flushed / Sweating-Mild, Additional Details... Read more
Systemic: she just had an anxiety attack-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: She notified me she didn't like needles before administration of the vaccine. I followed proper procedure to administer the vaccine. She then simply had an anxiety attack, which we provided her with ice packs to cool her down for. She insisted we called the ambulance. She remained responsive and alert the entire time. EMS did not need to take her into the hospital because she had calmed down a lot by the time they got here. So this is not due to the vaccine itself or the adminstration of it.
41 2021-07-05 numbness, tingling 90 minutes after vaccine, Right hand and right foot became tingly and numb suddenly. The feeling tra... Read more
90 minutes after vaccine, Right hand and right foot became tingly and numb suddenly. The feeling traveled to the left hand and foot. Progressively got worse. In the following days, numbness and tingling traveled to wrists and ankles too.
41 2021-07-05 tingling, difficulty speaking Within 15 minutes I had a band around my throat with pins and needles. I felt cotton mouth and my to... Read more
Within 15 minutes I had a band around my throat with pins and needles. I felt cotton mouth and my tongue had strange numbness, vocal changes, and arm was stinging. I had to wait 45 minutes but I also had within that time nasal congestion and I had nasal issues. The following day or two later I could not get out of bed, and I was just sleepy, tired, no appetite, and a headache and that lasted two days. No medical care.
41 2021-07-05 tingling, difficulty speaking Within 5-10 minutes of the vaccine I had Tingling in neck, vocal changes, tongue swelling, pins and ... Read more
Within 5-10 minutes of the vaccine I had Tingling in neck, vocal changes, tongue swelling, pins and needles around my neck ear to ear, ear congestion, tongue felt funny, arms and hands felt like pins and needles, pain in arm that had injection. It took longer than 45 minutes and had to stay 1 1/2 hour before leaving vaccine facility. I had to drink water and it was a much stronger reaction and longer than the first dose . The nurses at the facility did consider it as an allergy. The next day or two I had a headache and was laying in bed. By the 06/21/2021 I was diagnosed with shingles right in the area I had my surgery for my cancer on my hip which was strange. I am still itching by my tailbone, hip, and upper buttox.
41 2021-07-06 feeling hot, pain in extremity May 10th 1st shot - sleepy & a little itchiness on my skin May 31st 2nd shot- sleepy June 2nd - itc... Read more
May 10th 1st shot - sleepy & a little itchiness on my skin May 31st 2nd shot- sleepy June 2nd - itchiness at 1:45am in the morning which woke me up. I went to the bathroom and my entire body was broken out in hives. I immediately drove to the ER and was given benadryl, prednisone, and famotidine. 30 mins afterwards the allergic reaction went away. June 30th - woke up to itchy eyes and went to the mirror both eyes swollen like a plum. Went to the clinic and was given the same medications. July 4- right leg pain and warm to touch July 6th - went back to ER to have my right leg checked, no blood clots. Dr gave me muscle relaxers July 7th- itchy all over and hives all on my body
41 2021-07-07 cold extremities, hot flush, night sweats About 4 hours after receiving the vaccine, I felt really tired and got a headache. I went to bed and... Read more
About 4 hours after receiving the vaccine, I felt really tired and got a headache. I went to bed and profusely sweat throughout the night, but my feet were freezing. I woke up the next morning, and all my joints hurt. My knees, elbows, but especially my spine. It hurt to move in bed. I continued to experience the pain and hot flashes. On Sunday I finally felt normal. Everything seemed fine for a while and then in April I had some chest pains. I went to the ER where they saw my troponin levels were elevated. They did a catheter. An MRI showed there was no scarring or signs of damage. I do not have a history of high cholesterol, blood clots, high blood pressure or anything like that. My doctors are struggling to find an answer to this because I have no pre cursors for these conditions. I was not taking any medications; I had no other illnesses. I am a nurse, but I always wear appropriate PPE when dealing with patients. Since then, everything has remained normal to this point. I now take a baby aspirin every day, cholesterol medication and About 4 hours after receiving the vaccine, I felt really tired and got a headache. I went to bed and profusely sweat throughout the night, but my feet were freezing. I woke up the next morning, and all my joints hurt. My knees, elbows, but especially my spine. It hurt to move in bed. I continued to experience the pain and hot flashes. On Sunday I finally felt normal. Everything seemed fine for a while and then in April I had some chest pains. I went to the ER where they saw my troponin levels were elevated. They did a catheter. An MRI showed there was no scarring or signs of damage. I do not have a history of high cholesterol, blood clots, high blood pressure or anything like that. My doctors are struggling to find an answer to this because I have no pre cursors for these conditions. I was not taking any medications; I had no other illnesses. I am a nurse, but I always wear appropriate PPE when dealing with patients. Since then, everything has remained normal to this point. I now take a baby aspirin every day, cholesterol medication and plavix.
41 2021-07-08 night sweats, pain in extremity lost 20 pounds; They said the vaccine is attacking the caller's kidneys; pain when she urinates; Pat... Read more
lost 20 pounds; They said the vaccine is attacking the caller's kidneys; pain when she urinates; Patient was mentally distraught; urinating blood; urinating blood was reported as worsened; body aches; Night sweats; Cold; Fever; Chills; Nausea; Tiredness; arm soreness; blood clots are coming out of her bladder; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, in the left arm on 06Mar2021, as a single dose for COVID-19 immunisation. Medical history and concurrent conditions included hysterectomy in 2016. Concomitant medication was not reported. On 06Mar2021, patient had blood clots are coming out of her bladder, night sweats, cold, fever, chills, nausea, tiredness, arm soreness. On 18Mar2021, patient had urinating blood and urinating blood was reported as worsened and body aches. On an unspecified date, patient had lost 20 pounds and vaccine was attacking the patient's kidneys, pain when she urinates and patient was mentally distraught. On 18Mar2021 the patient started urinating blood and it has not stopped since then and has been in and out of the hospital because of this. All of these symptoms began after received the vaccine so she knows this was related. Patient had a hysterectomy in 2016 so she knows that this was not vaginal bleeding. She had cystoscopies, stents placed, ultrasounds, and 3 CTs. This has been hell and the patient was running up doctor bills trying to figure it out. They said the vaccine was attacking the patient's kidneys. On paper, the patient was okay but she was urinating blood and blood clots are coming out of her bladder. She has lost 20 pounds and doesn't know if it was from the vaccine or the stress of everything. This was scary as hell and very stressful because the patient doesn't know what the vaccine was doing to her body. Patient also has body aches was like a tightness in hands, feet and legs, it feels like arthritis and pain when she urinates because the clots are big enough. Patient has been taking pictures since this started, her urine was like merlot wine. Patient had seen a nephrologist, a urologist and primary care physician. The caller was never admitted to the hospital as a patient when she visited the emergency room. They would test and make sure she wasn't in imminent danger and then would send her home because of COVID. Patient went to emergency room the first time on 19Mar2021, because she noticed the blood in her urine, also emergency room on 22Mar2021. The patient ended up in the emergency room these times because the symptoms were severe or the bleeding was more. Lab test included on an unspecified date, blood work and result was blood looks like merlot wine. On 19Mar2021, X-ray result was normal. On 22Mar2021, ultrasound of kidney was done and result was normal. On 06Apr2021, bladder biopsy was performed, result was normal, CT scan was negative, cystoscopy and placed stents was normal and no cancer. On 12Apr2021, they removed the stents and did cystoscopy that was negative. On 22Apr2021, CT with contrast was negative. On 23Jun2021, ultrasound of kidney was normal. They did a test on 01Jun2021 where the urologist put a catheter inside and was trying to see if the had an obstruction. The doctor flushed water in and pulled the water out. Every 2 weeks the patient was getting blood work to make sure her kidneys aren't failing and her liver was okay. Patient received the 2nd dose on 27Mar2021, and went to the ER when the blood first started. Outcome for night sweats, cold, fever, nausea, tiredness and arm soreness on 13Mar2021, was resolved. Outcome for event urinating blood and urinating blood worsened and body aches was not recovered. Outcome for event lost 20 pounds, blood clots are coming out of her bladder and vaccine was attacking the patient's kidneys, pain when she urinates and mentally distraught was unknown.
41 2021-07-09 weakness, speech disorder, unresponsive to stimuli Pt became unresponsive about 5 minutes after the vaccine. Almost like she was in a daze, she was br... Read more
Pt became unresponsive about 5 minutes after the vaccine. Almost like she was in a daze, she was breathing and had pulse, but could not tell us her name or focus on us. 911 was called, they did EKG, gave oxygen, gave saline, checked blood pressure, pulse and blood sugar. She responded a tiny bit to the smelling salt but still could not talk or had any strength in her arms. They took her to the hospital
41 2021-07-09 tingling Patient's arm started to get a red rash with tingling down her arm almost immediately after vaccinat... Read more
Patient's arm started to get a red rash with tingling down her arm almost immediately after vaccination. Did not spread past the right arm. Patient took a Benadryl and stayed for 30 minutes for observation. The rash did not progress any further and patient went home after 30 minutes. Spoke to patient 7/10/21 (next day) and she is doing fine, rash and tingling resolved.
41 2021-07-10 migraine Trouble breathing; Acute migraine; Hives; Muscular pain; This is a spontaneous report from a contact... Read more
Trouble breathing; Acute migraine; Hives; Muscular pain; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9263) via an unspecified route of administration, in Arm Right on 26Feb2021 13:15 (at the age of 41 years old), as single for COVID-19 immunisation. Medical history included asthma and allergy to penicillin. The patient did not receive other vaccine within four weeks of COVID vaccine and she did not take other medications within two weeks of vaccination. The patient did not have COVID prior to vaccination. The patient concomitant medications were not reported. On 28Feb2021 15:00, the patient experienced trouble breathing, acute migraine, hives, and muscular pain. These adverse events resulted in emergency room/department or urgent care visit. The patient received treatment with benadryl and pain medicine. The patient did not test for COVID post vaccination. The outcome of all the events were resolved, on an unspecified date in 2021.
41 2021-07-11 numbness, tingling, tremor, flushing Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tingli... Read more
Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient visibly nervous about getting vaccine. No issue at time of injection. After about 3 minutes developed sweats (patient attributes potentially to nervousness) and tingling/numbness in extremities. Assessment of patient did not warrant epinephrine administration or contact EMS. Advised patient may take benadryl/acetaminophen. Contact MD if symptoms are not resolving.
41 2021-07-11 tingling, numbness Acute numbness and thinking in pinky and ring finger is left hand. Ongoing since onset 24-7. No diag... Read more
Acute numbness and thinking in pinky and ring finger is left hand. Ongoing since onset 24-7. No diagnosis yet, awaiting appointments and further tests. Not sure if it is related or coincidental but wanted to report in case it is.
41 2021-07-12 pain in extremity Flu-like symptoms; Sore arm; This is a spontaneous report received from a contactable consumer, the ... Read more
Flu-like symptoms; Sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old non pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via an unspecified route administration in left Arm on 27Mar2021 at 1145 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included as mild asthma and overstimulated amygdala. The patient had no known allergies to medications, food, or other products. The patient had received other unspecified medications in two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in left Arm on 06Mar2021 at 1130 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 2100, the patient experienced sore arm and flu-like symptoms (headache, body aches, weak, fatigue and fever). The patient did not receive any treatment for the events The patient did not receive any treatment for the reported events The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sore arm and flu-like symptoms (headache, body aches, weak, fatigue and fever were recovering at the time of report. No follow-up attempts are needed. No further information is expected.
41 2021-07-14 pain in extremity, seizure On April 10th, I developed unprovoked pain in my lower left calf. I went to my primary doctor April ... Read more
On April 10th, I developed unprovoked pain in my lower left calf. I went to my primary doctor April 12th, who sent me for a doppler scan to rule out DVT. It came back negative. I was told it was likely a calf muscle strain & to rest it. The pain was still active when I received my second vaccine dose on April 18th. On April 19th, I fainted at home, had several seizures, and difficulty breathing. I was sent by ambulance to the emergency room. There I suffered a massive pulmonary embolism, cardiac arrest, and numerous cascading issues affecting my liver, lungs, kidneys. I underwent a thrombectomy and several other procedures. I was told by doctors that less than 10% of people survive what I went through. con't
41 2021-07-16 pain in extremity I was afraid to receive any of the none PDA approved vaccine shots because of side effects. After my... Read more
I was afraid to receive any of the none PDA approved vaccine shots because of side effects. After my 1st dose i felt pain later that day and i had diarrhea. My left arm was sore and my left lung hurt worse. I know the arm is supposed to hurt but not my lung. After two days my arm didn't hurt as much but it's day three and my lung still hurts so bad. With every move i make my lung slows me down. I haven't been able to do my daily task or sleep at night. I just want the pain to go away. My family and friends are scaring me by saying that i might have a blood clot developing in my lung. Today i have taken Tylenol to ease the pain and i made my own ice pack. If there's no change by morning i'm going to the ER. This pain makes me not want to get my second dose.
41 2021-07-17 burning sensation Swelling of face, lips & tongue.; Swelling of face, lips & tongue.; Swelling of face, lips & tongue.... Read more
Swelling of face, lips & tongue.; Swelling of face, lips & tongue.; Swelling of face, lips & tongue.; Redness & intense burning of face, neck & chest; burning of face, neck & chest; Chest os tight; Watery & dry eyes; Watery & dry eyes; Abdominal pain on & off; Joint pain first few days.; Sore throat; This is a spontaneous report received from a contactable consumer (patient). A 41-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in left arm on 05Apr2021 at 03:15 PM (vaccinated at the age of 41 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included endometriosis from an unknown date and unknown if ongoing. Allergies to medications, food, or other products includes Levaquin, latex & shellfish. The patient was received Estradiol within 2 weeks of vaccination, taken for an unspecified indication, start and stop date were not reported. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021 at 04:00 PM, the patient was experienced swelling of face, lips & tongue. Redness & intense burning of face, neck & chest (since date of vaccine-5 days so far). Chest os tight. Abdominal pain on & off. Watery & dry eyes. Joint pain first few days. Sore throat. The adverse event result doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event with Saw pcp. The patient was not diagnosed with COVID-19, prior to vaccination and since the vaccination, the patient was not tested for COVID-19. Outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
41 2021-07-17 feeling cold, feeling hot, migraine, pain in extremity Progressed to very sick; Temperature 99.5; head pain; Sore left arm first 2 days; depression; confus... Read more
Progressed to very sick; Temperature 99.5; head pain; Sore left arm first 2 days; depression; confusion; vertigo; body aches; dry eyes; back pain; light sensitivity; migraine; hot / cold; hot / cold but mostly very cold; no hunger; Brain fog; no thirst at all; chills; nausea; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6208), via an unspecified route of administration in the left arm on 13Mar2021 at 14:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish (only on a blood test), penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received escitalopram oxalate (LEXAPRO) and experienced drug allergy. Since the vaccination, the patient had been tested for COVID-19. On 14Mar2021 at 07:00, the patient had sore left arm first 2 days. Then, on unknown dates in Mar2021, the patient experienced brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back and head pain, light sensitivity, migraine, no hunger or thirst at all and hot / cold but mostly very cold with chills. On 18Mar2021 (Thursday), the patient missed work for the back and head pain. On 20Mar2021 (Saturday), the patient progressed to being very sick. Since 20Mar2021 to 24Mar2021 (reported as today), the temperature was 99.5. The patient missed the work from 22Mar2021 to 24 Mar2021 (at least). The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test on 22Mar2021 which included PCR with test type of nasal swab and the test result was negative. The patient received telemedicine prescribed nausea medication for the event of nausea. The clinical outcomes of the events sore left arm first 2 days, brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back pain, light sensitivity, migraine, no hunger or thirst at all, hot/cold, hot / cold but mostly very cold with chills, chills, head pain, progressed to very sick and temperature 99.5 were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
41 2021-07-17 flushing, hot flush Feeling flushed; Hot flashes almost; Chest tight; Tight side arm and chest sharp pain; Right ear fee... Read more
Feeling flushed; Hot flashes almost; Chest tight; Tight side arm and chest sharp pain; Right ear feeling full and tinnitus; Site pain soreness; Stiffness and all over body aches and muscle stiffness/tight side arm; All over body aches; Feeing generally not well; Scratchy throat but no swelling or otherwise allergic reaction.; This is a spontaneous report from a contactable consumer (patient reported for herself). A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER2613) via unspecified route of administration in the left arm on 18Mar2021 at 17:45 (at the age of 41-year-old), as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included blood clots, postpartum depression, overweight and sulfonamide allergy. Concomitant medications included Fluoxetine hydrochloride (PROZAC), ibuprofen (MOTRIN), paracetamol (TYLENOL), and fluticasone (FLONASE); all on unknown dates for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received levothyroxin(MANUFACTURER UNKNOWN) and metronidazole (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 18:00, the patient was feeling flushed, hot flashes almost, chest tight, tight side arm and chest sharp pain, right ear feeling full and tinnitus, that lasted off and on until the patient went to bed. The shot was completely painless but 20-30 minutes after vaccination, the patient had site pain soreness, stiffness and all over body aches and muscle stiffness. The patient was feeling generally not well and flushed, was by skin with no rash and had scratchy throat but no swelling or otherwise allergic reaction. The patient received treatment for the reported events and blood pressure was examined and observed for 45 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of feeling flushed, hot flashes, chest tight, chest sharp pain, tinnitus, vaccination site pain, stiffness, body aches, feeling unwell and scratchy throat was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2021-07-17 nerve pain, tingling Allergic reaction - tightening in throat; lower arm/nerve pain; tingling 6 days later; This is a spo... Read more
Allergic reaction - tightening in throat; lower arm/nerve pain; tingling 6 days later; This is a spontaneous report from a non-contactable consumer, the patient. A 41-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207) via an unspecified route of administration in left arm on March2021 as a single dose for COVID-19 immunisation (at the age of 41-years-old). Medical history included IBS from an unspecified date. The patient was allergic to shellfish. Patient took other medications in two weeks which included multivitamins(MANUFACTURER UNKNOWN), mentha x piperita oil (IBGARD), probiotic (FLORASTOR) from an unknown date for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other other vaccine within four weeks prior to vaccination. On an unspecified date in Mach2021 the patient experienced allergic reaction- tightening in throat, lower arm/nerve pain and tingling 6 days later. The patient did not receive any treatment for adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of allergic reaction- tightening in throat, lower arm/nerve pain and tingling was not recovered. No follow up attempts are needed. No further information is expected.
41 2021-07-17 pain in extremity suffocating and sometimes needs air; sore left arm; This is a spontaneous report from a contactable ... Read more
suffocating and sometimes needs air; sore left arm; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8731, expiration date unknown), via an unspecified route of administration, administered in Arm Right on 30Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. No relevant medical history and family history reported. Concomitant medication included ongoing norethindrone acetate (NORETHINDRONE ACETATE, LOT: 548586A, Expiry date: Jul2023) 0.35gm 1 pill a day by mouth taken for contraception, from an unknown start date. Patient did not receive any other vaccine prior to 4 weeks of vaccination. Patient previously received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0158, expiration date unknown), via an unspecified route of administration, administered in Arm Left on 08Apr2021 (at the age of 41 years) as DOSE 1, SINGLE for COVID-19 immunization. On an unknown date in Apr2021 post vaccination, the patient had sore left arm. On an unknown date in May2021, the patient experienced suffocation and sometimes needed air. Patient was still having an uncomfortable feeling in the arm. It was reported that when she felt like she needed air, it felt like her arm felt a bit better. It was like it moved from her arm to her chest and she started to feel like she was suffocated. It has been about a month since she started to feel suffocated like that. The patient was treated with Diclofenac and she stated that it is not helping her. The outcome of the events was reported as not recovered at the time of report. Investigation Assessment: No.
41 2021-07-17 pain in extremity feel like sometimes she needs air/feel like she is suffocated; Uncomfortable feeling on her arm; Thi... Read more
feel like sometimes she needs air/feel like she is suffocated; Uncomfortable feeling on her arm; This is a spontaneous report from a contactable female consumer (patient). The report was not related to a study or programme. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0158), via an unspecified route of administration, administered in arm left on 08Apr2021 (at the age of 41-year-old), as dose 1, single for covid-19 immunization. Medical history was none. No family medical history relevant to AE. Concomitant medications included Norethisterone (NORA-BE, Lot number: 548586A, Expiration date: Jul2023), orally on an unspecified date and ongoing at 0.35 g, daily for birth control. The patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in Arm right on 30Apr2021, as dose 2, single for covid-19 immunization. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AE(s) following prior vaccinations was none. Patient medical history (including any illness at time of vaccination) was none. On an unspecified date in Apr2021, the patient started having uncomfortable feeling on her arm and started feels like sometimes she needs air from an unspecified date in May2021. She reported that uncomfortable feeling on her arm from an unspecified date in Apr2021. She just wanted to ask about the vaccine she had in April after her first dose and said she was still having a uncomfortable feeling in her arm. She stated her symptoms started after she had the first vaccine. She did notice that she does feel like sometimes she needs air after receiving the vaccine too. She said that when she feels like she needs air, it feels like her arm feels a bit better. It is like it moves from her arm to her chest and she started to feel like she is suffocated. It has been about a month since she started to feel suffocated like that. She stated she was only taking birth control pills and unsure if it is causing her symptoms. It was reported that the events of uncomfortable feeling on her arm and feels like sometimes she needs air required a visit to emergency room (went once) and physician office (went once). She was given a medication of Diclofenac to treat the events by the doctor, but she did not feel that it is helping her. Relevant tests were none. No investigation assessment was performed. The clinical outcome of the feel like sometimes she needs air/feel like she is suffocated, uncomfortable feeling on her arm was not resolved at the time of this report.
41 2021-07-17 pain in extremity Sore arm; Mild headache; Nausea; Fatigue; This is a spontaneous report from a non-contactable consum... Read more
Sore arm; Mild headache; Nausea; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration on 11Mar2021 (age at vaccination 41-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient was allergic to macrobid. Patient's concomitant medications was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021, the patient experienced sore arm, mild headache, nausea and fatigue. No therapeutic measures were taken as a result of sore arm, mild headache, nausea and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of sore arm, mild headache, nausea and fatigue was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's first name's format updated, Vaccination Facility Country captured. Reaction of Past Drug Event updated as known allergies: Macrobid. Narrative updated from This is a spontaneous report from a contactable consumer to This is a spontaneous report from a non-contactable consumer.
41 2021-07-17 tingling Severe headache; nausea; vomiting; chest pain and tightness; chest pain and tightness; bitter taste ... Read more
Severe headache; nausea; vomiting; chest pain and tightness; chest pain and tightness; bitter taste in mouth; dizziness; tingling in hands and feet; painful arm from injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient's sister). A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on 31Mar2021 at 13:30 pm, as dose 2, single dose for covid-19 immunization (at the age of 41-years-old). Medical history included allergies, left bundle branch block and seasonal allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that after receiving the second dose of vaccine on 01Apr2021, the patient experienced severe headache, nausea, vomiting, chest pain and tightness, bitter taste in mouth, dizziness, tingling in hands and feet, painful arm from injection site. Patient was visited to doctor or other healthcare professional office/clinic visit for the adverse events. Reporter stated that patient informed about her side effects on 02Apr2021. Therapeutic measures were taken with zofran for the nausea/vomiting and advised to take Benadryl. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
41 2021-07-17 tenderness Swollen lymph mode; Tender; Sudden mass (ganglion?) above left collar bone; Sore; This is a spontane... Read more
Swollen lymph mode; Tender; Sudden mass (ganglion?) above left collar bone; Sore; This is a spontaneous report from a contactable consumer, the patient. A 41-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 27Mar2021 at 11:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia. The patient had no known allergies to medications, food, or other products were reported. Concomitant medications included VIT D3 (MANUFACTURER UNKNOWN) 50000 IU one per week, from unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 17:00 the patient experienced swollen lymph node, neck mass, sudden mass (ganglion) above left collar bone, sore and tenderness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the swollen lymph node, neck mass, sore and tenderness was not recovered. No follow-up attempts are needed. No further information is expected.
41 2021-07-19 feeling hot, flushing, feeling cold I felt perfectly fine until day 5 Ever since I feel very dizzy like motion sickness and nauseous mos... Read more
I felt perfectly fine until day 5 Ever since I feel very dizzy like motion sickness and nauseous most of the time. I am very nervous this will never go away. I get hot and flushed and then that goes away and I'm chilled with goosebumps. I feel ill most of the day
41 2021-07-19 feeling hot, numbness, tingling All over pain. every muscle and joint started hurting after 2nd day. sharp pains in chest and left s... Read more
All over pain. every muscle and joint started hurting after 2nd day. sharp pains in chest and left side . hands numbs. feet tingle and hot. brain fog .
41 2021-07-19 pain in extremity, muscle spasms Chattering teeth; worst leg aches; worst leg aches and cramps ever; nausea; dizziness; huge headache... Read more
Chattering teeth; worst leg aches; worst leg aches and cramps ever; nausea; dizziness; huge headache; low grade fever; diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 14:00(at the age of 41-year-old) as a single dose for COVID-19 immunisation. No relevant medical history was reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and vitamins for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced chattering teeth, worst leg aches and cramps, nausea, dizziness, huge headache, low grade fever and diarrhoea. On an unknown date, the patient underwent body temperature measurement and result was found to be 99.6 F. No therapeutic measures were taken for the events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care The clinical outcome of all the events chattering teeth, worst leg aches and cramps, nausea, dizziness, huge headache, low grade fever and diarrhoea were resolving at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained
41 2021-07-19 tingling Rapid heartbeat; tingling in hands andarms,; light headedness; dizziness; nausea; This is a spontane... Read more
Rapid heartbeat; tingling in hands andarms,; light headedness; dizziness; nausea; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 12:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 12:45 the patient experienced rapid heartbeat, tingling in hands and arms, light headedness, dizziness and nausea. The adverse events did not result in consultation to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events of rapid heartbeat, tingling in hands and arms, light headedness, dizziness and nausea was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2021-07-20 breast pain Extreme amount of pain in both breasts; swollen and full of lumps; swollen and full of lumps; This i... Read more
Extreme amount of pain in both breasts; swollen and full of lumps; swollen and full of lumps; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: unknown) via an unspecified route of administration in the left arm on 11Mar2021 at 12:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included tetanus vaccine (MANUFACTURER UNKNOWN) for an unknown indication received on 25Feb2021, atorvastatin (MANUFACTURER UNKNOWN) for an unknown indication and levothyroxine sodium (SYNTHROID) for an unknown indication received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient received other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 12:00 the patient experienced extreme amount of pain in both breasts and they were swollen and full of lumps. The patient reported as extreme amount of pain in both breasts for ten days following the first shot and any amount of movement caused pain and they were swollen and full of lumps that were not normally there for ten full days, which started on day 2 post shot. The patient underwent nasal swab COVID-19 PCR virus test on 22Mar2021 and was tested negative. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care'. The clinical outcome of extreme amount of pain in both breasts, swollen breasts and breast lumps were resolving. No follow-up attempts are needed; information about lot number cannot be obtained.
41 2021-07-20 numbness I started to feel a lil pain in my ear. I started to have numbness and dizziness. The left side of m... Read more
I started to feel a lil pain in my ear. I started to have numbness and dizziness. The left side of my face went numb. I went to the emergency room and they told me I had problems with my brain. They ran a few test on me. I had no headache at first then I started to get a small one.
41 2021-07-21 weakness Patient presented w/ cough, fever, myalgia, weakness and joint pain of unknown duration to ED. Teste... Read more
Patient presented w/ cough, fever, myalgia, weakness and joint pain of unknown duration to ED. Tested positive for COVID-19 by PCR on 7/21/21. Received Pfizer vaccines on 1/6/21 and 1/28/21.
41 2021-07-21 numbness, tingling Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Sys... Read more
Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Loss of mental focus and vision got blurry-Severe, Systemic: Headache-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Tongue was tingling all over, hands and feet were going numb
41 2021-07-21 muscle spasms, nerve pain, muscle twitching Horrible issues the last four months. 1. Early period /cycle is off 2. Gastrointestinal issues 3. N... Read more
Horrible issues the last four months. 1. Early period /cycle is off 2. Gastrointestinal issues 3. Nerve pain 4. Muscle spasms and twitches 5. Thyroid went out of control 6. Went to ER with shortness of breath and chest pains
41 2021-07-21 muscle twitching persistent, systemic muscle twitching
41 2021-07-21 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-p... Read more
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 02Apr2021 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Other medications in two weeks was reported as yes. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021 at 13:15, the patient experienced sore arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event sore arm was recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
41 2021-07-22 inability to speak, slurring, weakness This is an addendum to a previous report I filed (VAERS ID: 1446698, E-Report Number: 578250). My re... Read more
This is an addendum to a previous report I filed (VAERS ID: 1446698, E-Report Number: 578250). My reaction continued and got much worse after I filed the other report. About an hour after I received the first shot of the Pfizer Covid vaccine, I started to have an allergic reaction. I felt very dizzy and weak, my throat started to close up, and my heart rate was all over the place. I took some Benadryl and some other antihistamines and that reversed the allergic reaction. I didn't need my EpiPen. About 6-7 hours after I got vaccinated, I started to experience a strange neurological event. It was like I was extremely drunk. I was slurring my speech, my vision went dark & blurry, I was very confused, couldn't make the right words, couldn't remember how old I was. My friend called 911 and sent paramedics to my house. They assessed me for a stroke or heart attack and said my heart rate & blood pressure were very unstable, but it didn't appear that I was having a stroke or heart attack at the time. I refused to go to the hospital as it was 4th of July, very late at night, and I was confused about how I was going to get home (I live very rurally and didn't have a partner who could have come with me). The next day I went to the hospital. They said something was going on with my heart and referred me for follow up care. They said I had an abnormal EKG. The ER doctor said I did appear to have an allergic reaction and advised me not to get the second shot. He could not explain the neurological event. He said it could have been a TIA or something similar, but there would be no way to evaluate that unless I had a brain scan at the time of the reaction. He advised me to follow up with my PCP and a cardiologist and any other specialists I may need. It has been nearly 3 weeks since I had the vaccine injury and I am still having heart problems. I am waiting on follow-up care with a cardiologist, but they are booked 2 months out so I don't know what's going on. I have palpitations several times a day, and shortness of breath. Sometimes it's very difficult to breathe. These episodes come on suddenly and will resolve, but will happen again throughout the day. Sometimes at night my heart will be pounding so hard it wakes me up. Sometimes if I'm lying in bed, I can see my heart pounding so hard it shakes my chest and abdomen. This is new and has not happened to me before. It's worse on exertion but happens when I'm sitting or lying down. I don't know what this condition is, but I did not have it before I got vaccinated. It doesn't appear to be myo- or pericarditis, as there is no severe chest pain or fever. I think it's something else, but so far nobody can tell me what it is.
41 2021-07-22 breast pain, pain in extremity Heat and swelling at injection site 12 hours post vaccine continuing until at least 23 hours post va... Read more
Heat and swelling at injection site 12 hours post vaccine continuing until at least 23 hours post vaccine when reported Pain and weakness in right hand 13 hours post vaccine continuing until at least 23 hours post vaccine when reported Heart racing and trouble breathing 16 hours post vaccine intermittent symptoms coming and going continuing until at least 23 hours post vaccine when reported Nausea 17 hours post vaccine intermittent symptoms coming and going continuing until at least 23 hours post vaccine when reported Swollen and painful lymph node in right armpit 21 hours post vaccine continuing until at least 23 hours post vaccine when reported Pain in right breast 21 hours post vaccine continuing until at least 23 hours post vaccine when reported
41 2021-07-22 discomfort Feel discomfort; Swollen lymph node under arm; This is a spontaneous report from a non-contactable c... Read more
Feel discomfort; Swollen lymph node under arm; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6206) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 (at the age of 41-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient did not have a history of allergies to medications, food or other products. Concomitant medication taken within two weeks included diazepam; isopropamide iodide (VALTRAX) received on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On unknown date in Mar2021, the patient experienced swollen lymph node under arm where vaccine was administered. It was reported that, after first dose lump appeared 3 to 4 days later and got bigger and experienced discomfort for almost two weeks and still it was a small lump (at the time of this report). On 02Apr2021 after second dose within 8 hours, the patient experienced swollen lymph node. It was reported that lump was swollen, size of baseball and the patient felt discomfort when she put her arm down by side. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swollen lymph node under arm and feel discomfort were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2021-07-22 feeling hot, cold sweat Cold sweat; Feeling overheated; Sudden fatigue; This is a spontaneous report from a non-contactable ... Read more
Cold sweat; Feeling overheated; Sudden fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in the left arm on 03Apr2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), acetylsalicylic acid;caffeine;paracetamol (EXCEDRIN) and melatonin (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 15:00, the patient experienced cold sweat though feeling overheated and sudden fatigue. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events cold sweat, feeling overheated and sudden fatigue were recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
41 2021-07-22 pain in extremity acute DVT in Left leg, has bilat leg pain
41 2021-07-22 pain in extremity She is experiencing mild pain on the upper arm where she got the vaccine. It is not even that painfu... Read more
She is experiencing mild pain on the upper arm where she got the vaccine. It is not even that painful, it comes and goes.; She is experiencing mild pain on the upper arm where she got the vaccine. It is not even that painful, it comes and goes.; This is a spontaneous report from a contactable consumer (Patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 08May2021 10:15 as (At the age of 41-years) DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have patient history and investigation assessment. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0162) on 17Apr2021 at 10:28AM into left arm for COVID-19 immunization. The patient experienced she is experiencing mild pain on the upper arm where she got the vaccine. it is not even that painful, it comes and goes on 11Jul2021. It was reported that Caller is a consumer who received her Pfizer-Biontech Covid19 vaccine series approximately 2 months ago. She is now reporting she is experiencing mild pain on the upper arm where she got the vaccine. She states it's not even that painful, just a sensation that she was noticing, and that the sensation comes and goes. Reporter was asking Has this been reported before. Response: Spoke from Fact Sheet Sect 6.1: Solicited Local and Systemic Adverse Reactions Across both age groups, 18 through 55 years of age and 56 years and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days). Later patient was reported that She now has a very mild pain on her upper arm where she received the covid vaccine. It is not even that painful, it comes and goes: It just began yesterday. She cannot even call it a pain because it is very mild. She is just concerned because she is not sure what it is. It is bothering her, but it is very mild. It happens maybe one or two times an hour. It is so mild that she did not take Ibuprofen. Reporter seriousness for events: Unspecified. The outcome of events was not recovered. Information on the lot/batch number has been requested.
41 2021-07-23 pain in extremity I've had this neck pain and heel pain in the past. But it was exacerbated after the vaccine and new ... Read more
I've had this neck pain and heel pain in the past. But it was exacerbated after the vaccine and new pain: joints - both of my knees and my hips - generalized achiness that has persisted since then. I had a heel spurt in my right foot treated in 2009 with steroid injections and no problem whatsoever for years until last two months - constantly. Right hip and right knee - I have never had had pain there before and now I'm having consistent pain there in those places. No testing on that. I have taken a dose pack of steroids to see if that would help. I have taken two rounds of that for my neck and for my foot. It helped my neck but the pain is still there - it just made it less and it hasn't really helped my foot. I've also been in physical therapy for my neck and shoulder. I really feel like it's gotten worse after my vaccine. I did get COVID between between my two vaccines - it was two weeks after the first dose. I am wondering if this is a long term affect of COVID or the COVID vaccination. I am still am dealing with the pain.
41 2021-07-23 sensory loss, pain in extremity, migraine lost all feeling in my left hand; getting migraines 1-2x a week; more tired than I used to be; pain ... Read more
lost all feeling in my left hand; getting migraines 1-2x a week; more tired than I used to be; pain and stiffness in left hand that feels like what I imagine arthritis to feel like; pain and stiffness in left hand that feels like what I imagine arthritis to feel like; pain and stiffness in left hand that feels like what I imagine arthritis to feel like; pain and stiffness in left hand; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5398, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Feb2021 at 13:00 hours as dose 2, single (at the age of 41-years-old) for covid-19 immunisation at Clinic/ Administration facility. Medical history included ongoing migraine (got one every year or so), tired and known allergies to shellfish from an unknown date and unknown if ongoing. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications within 2 weeks of vaccination. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246, Expiration date and NDC number was not reported), via an unspecified route of administration, administered in left arm on 15Jan2021 at 13:00 hours as dose 1, single (at the age of 41-years-old) for covid-19 immunisation. Patient was not diagnosed with COVID-19, prior to vaccination. On 01Mar2021, since her second vaccine, patient had pain and stiffness in her left hand that feels like what she imagines was arthritis to feel like, getting migraines 1-2x a week (previously she got one every year or so), and she was more tired than she used to be. On Jun2021, when she flew via airplane, patient lost all feeling in her left hand and it had hurt much more since then. Patient considered all the events serious (disabling/incapacitating). Patient went to doctor or other healthcare professional office/clinic visit for disability or permanent damage. Patient had been tested for COVID-19 by nasal swab, Sofia Antigen on 12Jul2021 and result was negative. Therapeutic measures were taken as a result Imatrex for migraines Motrin for hand. The outcome of all the events was not recovered. Follow-up attempts are completed. No further information is expected.
41 2021-07-25 weakness 2nd shot received on 5/24. Back pain days 1 and2. Headache, chest pain, neck pain days 1-3. Day 4... Read more
2nd shot received on 5/24. Back pain days 1 and2. Headache, chest pain, neck pain days 1-3. Day 4, right half of tongue swollen, 5 canker sores on bottom. Day 5, difficulty swallowing, prescribed Prednisone. Mouth healed within 5 days of medication. Headache started on June 4th. Mild for 2 weeks then increased in pressure and duration. Visited doctor on 7/1, CT scan pending insurance approval. Advil does not help at all. Allergy medicine and nose spray have no effect. Benadryl & Excedrin Migraine work for a couple of days then stop. Debilitating pain that I cannot deal with any longer.
41 2021-07-26 breast pain heavy head with extreme fatigue like waking up from surgery. Lasted for 7 days. nausea came and wen... Read more
heavy head with extreme fatigue like waking up from surgery. Lasted for 7 days. nausea came and went for 10 days. congestion in chest with little phlegm started day of shot, approx. 30 minutes post injection and will occur seldom since till now. left peck pain in what felt like my breast rather than in my chest cavity. has been occurring very seldom since 3rd day post shot until now.
41 2021-07-26 burning sensation Started with small rash under armpit same arm as injection. Treated with topical cream, no better. ... Read more
Started with small rash under armpit same arm as injection. Treated with topical cream, no better. Within 2 weeks spread to whole armpit. Went to dermatologist. Steroid shot and topical meds given. Meds helped for 1 week, then started spreading again. By now, it's time for 2nd shot. A couple of days after second shot, same rash was under both arms, itchy, whelps, burning. Started moving onto my breast and side (right side). Back to derm (more steroids and creams - miserable). A few days later, i began to have blisters and rashes all over my body. Mainly arms, between fingers, entire stomach, top of thighs. Moved into my mouth, gumlines bleeding and shedding skin, breast had blisters, vaginal area and rear end bleeding from blisters and rash. Went to HCF and was given heavier dose of steroids, creams and added heavy antihistamine. Worked and calmed for a few days for the itching, then came right back. The rashes are no longer a huge issue but under my armpits (along with blistering) but the itching is intense.. My whole body itches. Nothing helps, no rashing just horrible itching from the inside out. Something has to be done
41 2021-07-26 migraine, numbness Has an instant reaction of feeling faint, pounding heart, and numbness in arms and fingers. Being tr... Read more
Has an instant reaction of feeling faint, pounding heart, and numbness in arms and fingers. Being treated for chronic dizziness/lightheadedness and migraine.
41 2021-07-26 pain in extremity The joints in my hands and feet keep swelling. They ache horribly. Nothing really helps.
41 2021-07-27 facial pain The next morning I woke up to both of my lips very swollen and painful; Later that day, my cheeks al... Read more
The next morning I woke up to both of my lips very swollen and painful; Later that day, my cheeks also started swelling and painful; Later that day, my cheeks also started swelling and painful; Approx 20 hours after receiving my 2nd dose, I felt a swelling in my lip in one spot, upper lip right side, just off center of my mouth. The next morning I woke up to both of my lips very swollen; This is a spontaneous report from a contactable consumer (Patient). A 41-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186 ), dose 2 intramuscularly, administered in Deltoid Right (Right arm) on 18May2021 at 15:15 (Age at vaccination: 41 years) as single dose for covid-19 immunisation. Vaccine Facility Type was Doctor's office/Urgent care. Patient medical history was none. Patient had none known allergies. The patient's concomitant medications were not reported. Patient received dose 1 on 27April2021 at 15:15, intramuscularly in right arm with lot number Ew0175. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient did not received any other medications within 2 weeks of the vaccination. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient stated approx 20 hours after receiving her 2nd dose, she felt a swelling in her lip in one spot, upper lip right side, just off center of her mouth on 19May2021 at 11:00, the next morning on 20May2021, she woke up to both of her lips were very swollen and painful. Looked like she had major fillers done. she could hardly drink. later that day, her cheeks also started swelling and painful. Cheeks Felt similar to a sinus infection but in her whole cheeks on the bone area, almost ears to nose vs just sinus area. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient received steroids for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. Device Date was reported as 20May2021. Physician consider the Pfizer product had a casual effect to the adverse event. The outcome of the events was unknown.
41 2021-07-27 hot flush, discomfort, pain in extremity Headache; Sore arm; Feeling of heaviness in body; Severe hot flashes; This is a spontaneous report f... Read more
Headache; Sore arm; Feeling of heaviness in body; Severe hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 03Apr2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to adhesive. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:00, the patient experienced headache, sore arm, feeling of heaviness in body and severe hot flashes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache, sore arm, feeling of heaviness in body and severe hot flashes was resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
41 2021-07-27 numbness, bell's palsy I was monitored at the clinic because my anxiety increased my BP. I was released after 30 more min... Read more
I was monitored at the clinic because my anxiety increased my BP. I was released after 30 more minutes. I took my hydroxyzine when I went home, and then planned to take it across the day (Up to 3 a day). At 3PM, I started to feel my left side inner mouth feel swollen and my jaw area, cheek, left side became numb and remained that way for 2 weeks. Went to ER that night at 4PM, ER Dr. said "bells palsy like" symptoms that would go away in time. Consulted with primary and told him of my concerns before getting second vax, he recommended I proceeds with second Vax.
41 2021-07-27 numbness, throat numbness 30 to 40 mins after injection an numbness creeped up my shoulder from the injection site; Numbed the... Read more
30 to 40 mins after injection an numbness creeped up my shoulder from the injection site; Numbed the left side of face and throat.; Numbed in left side of face and throat.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6198) via an unspecified route of administration in the left arm on 17Mar2021 at 14:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no known allergies to medications, food, or other products. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), naproxen (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 15:00, 30 to 40 minutes after vaccination, the patient experienced numbness creeped up her shoulder from the injection site, and numbed the left side of face and throat. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events numbness creeped up her shoulder from the injection site, and numbed the left side of face and throat was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
41 2021-07-27 pain in extremity Headache; Fatigue; Right arm injection site swollen; Right arm injection site red; Sore arm; This is... Read more
Headache; Fatigue; Right arm injection site swollen; Right arm injection site red; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 26Apr2021 at 13:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Concomitant medications included ascorbic acid (VITAMIN C) from an unknown date and for an unknown indication. The patient previously took duricef and shellfish. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021 at 13:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021, the patient experienced headache, fatigue, right arm injection site swollen and red and sore arm. The clinical outcome of the events headache, fatigue, right arm injection site swollen and red and sore arm were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2021-07-27 pain in extremity Sore left arm; Leg muscle pain; Fatigue; Low grade fever; This is a spontaneous report from a contac... Read more
Sore left arm; Leg muscle pain; Fatigue; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 27Apr2021 at 10:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included norethisterone acetate; ethinylestradiol (JUNEL FE 24), levothyroxine 112 micrograms (MANUFACTURER UNKNOWN) and metformin hydrochloride (METFORMIN ER 500) all for an unknown indication from an unknown date. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 06Apr2021 at 10:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 at 20:00, the patient experienced sore left arm for 48 hours, leg muscle pain for 08 hours, fatigue for 24 hours and low-grade fever for 30 hours. The clinical outcome of the events muscle pain was resolved on 28Apr2021 at 04:00; fatigue was resolved on 28Apr2021 at 20:00; low grade fever was resolved on 29Apr2021 at 02:00 and sore left arm was resolved on 29Apr2021 at 20:00. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
41 2021-07-27 speech disorder, nerve pain, muscle twitching, muscle spasms, pain in extremity, electric shock sensation Anaphalactic Reaction treated by double dose of hydroxyzine on site at clinic. Throat swelling - ha... Read more
Anaphalactic Reaction treated by double dose of hydroxyzine on site at clinic. Throat swelling - hard to swallow all day - went away next day. 4/22 - Legs heavy, tired for two days. May 8: Spasms/Twitching - Left side of head behind ear, which continues to this day. May 10 - Hearing loss - ear muffled, full feeling; Entire left side head felt inflamed, swollen at base of skull. Dr. sent bloodwork which showed high inflammation marker. Said I needed temporal artery biopsy. Consulted with surgeon that day and scheduled for biopsy on 5/11, which came back negative for arteritis. During surgery recovery started 16 day prednisone taper after inflammation still high crp levels. this helped my ear in the long run. still have tinnitus. Since 5/10 I've been seeing Drs for all left side symptoms of: tinnitus, nerve pain, sharp stabbing pains in head, moving nerve pains in head, base of skull pain, left side head soreness - dull, achy, burning, sharp - ever changing in nature, insomnia, new allergic reactions to different foods, anxiety, new electrical shocking/zaps in left toes and in front teeth, PTSD from th severity and frequency of symptoms, eye floaters/damage, spasms/twitching. Been in physcial therapy for 6 weeks. New nerve pains in limbs. Lightheadedness and some speech changes. Similar to COVID long haulers - never had COVID.
41 2021-07-28 discomfort Two days following the injection I began breaking out in rashes. First my arms and wrists, then by l... Read more
Two days following the injection I began breaking out in rashes. First my arms and wrists, then by legs, ankles and feet. The worst is the back of my head and neck. In the beginning it was really bad. No hospitalization was needed.
41 2021-07-28 numbness, tingling 10 MINUTES POST VACCINATION PATIENT BECAME DIAPHORETIC, RAPID BREATHING, TACHCARDIA, PROGRESSED TO N... Read more
10 MINUTES POST VACCINATION PATIENT BECAME DIAPHORETIC, RAPID BREATHING, TACHCARDIA, PROGRESSED TO NUMBNESS AND TINGLING IN DISTAL EXTREMITIES. EVALUATED IN THE HOSPITAL ED FOR OBSERVATION
42 2021-01-01 pain in extremity Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue s... Read more
Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site
42 2021-01-01 tingling, feeling cold Initial: Cold sensation and tingling in left arm and hand Next 3-5 days mild tingling in Left arm, L... Read more
Initial: Cold sensation and tingling in left arm and hand Next 3-5 days mild tingling in Left arm, Left hand/wrist, Left fingertips and some on left side of face
42 2021-01-02 hot flush After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat,... Read more
After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat, c/o "tonsil swelling"....
42 2021-01-02 tremor Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive... Read more
Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive skin, and mild headache. All symptoms resolved after 1 day.
42 2021-01-03 numbness arm numbness
42 2021-01-03 pain in extremity Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. To... Read more
Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. Took anti nausea meds for 4 days.
42 2021-01-03 pain in extremity Sore arm.
42 2021-01-03 pain in extremity began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had fin... Read more
began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had finally noticed was swollen. EMS was called and I was sent to the ER.I was given benedryll by ems, at ER I was given a steroid, Claritin and another medication for the reaction. Discharged with epi pens, a round of steroids, benedryl initially which was changed to Claritin by follow up dr.
42 2021-01-03 tremor Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for... Read more
Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for right deltoid after first dose. Hemodynamically stable and afebrile. Differential diagnosis includes but is not limited to allergic reaction, anxiety, panic attack, asthma attack, sequelae of hyperthyroidism. After resting comfortably in the room for approximately 15 minutes, she reported that her symptoms were starting to subside. She happily excepted diphenhydramine (dose not documented). She was observed for 2.5 hours and had no worsening of symptoms. Her vital signs were stable and she had appropriate SPO2 on room air throughout her stay in the emergency department. We discussed strict return precautions for evidence of allergic reaction, chest pain, worsening shortness of breath, altered mental status or fever. She will follow-up with her primary care doctor. Discharged in stable condition to the care of her husband.
42 2021-01-04 weakness Headache started 20 minutes after vaccine was administered Left arm feels very heavy, weak started 4... Read more
Headache started 20 minutes after vaccine was administered Left arm feels very heavy, weak started 40 minutes after vaccine was administered
42 2021-01-04 burning sensation itching immediately after injection; then burning; then redness traveling up arm into chest; immedia... Read more
itching immediately after injection; then burning; then redness traveling up arm into chest; immediate onset of diarrhea; This is a spontaneous report from a contactable nurse(patient). A 42-year-old female non-pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=el0140), intramuscular on 26Dec2020 09:30 at left arm at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient had no known allergies and no other medical history. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced itching immediately after injection, then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. Adverse event start date was 26Dec2020 09:30 AM. The events result in emergency room/department or urgent care. Treatment of Pepcid, Benadryl and prednisone received. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Dec2020.
42 2021-01-04 flushing flushed; noticed some hives on forehead and forearm; This is a spontaneous report from a non-contact... Read more
flushed; noticed some hives on forehead and forearm; This is a spontaneous report from a non-contactable nurse. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730), intramuscular on the left arm on 18Dec2020 09:30 at single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications were not reported. The patient previously took NSAIDS and experienced allergies. The patient flushed and noticed some hives on forehead and forearm on 18Dec2020 10:15. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of flushing was not recovered while for hives recovered on Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-01-04 pain in extremity, weakness arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills ... Read more
arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision
42 2021-01-04 pain in extremity, night sweats Sore arm; nocturnal diaphoresis; generalized mild pain; fatigue; This is a spontaneous report from a... Read more
Sore arm; nocturnal diaphoresis; generalized mild pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EJ1685), via an unspecified route of administration, on 18Dec2020 at 02:45 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 42-years-old. No other vaccine was received in four weeks. Medical history included prior to vaccination the patient diagnosed with COVID-19 and known allergies were Penicillin (PCN), ephedrine, calamine, calendula, pollen. Concomitant medications included escitalopram 10mh. On 19Dec2020 at 07:00 AM, the patient experienced sore arm, nocturnal diaphoresis, generalized mild pain, fatigue. The events were reported as non-serious. The patient recovered in Dec2020 form the events. No treatment was received.
42 2021-01-04 pain in extremity Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of... Read more
Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. There was no medical history. Concomitant medication in two weeks included vitamin d3, cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain and tiredness on 17Dec2020 at time of 09:00 AM. No treatment received for these events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
42 2021-01-04 tingling, numbness Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (st... Read more
Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (started 1/4 - lasted approximately 10 hours)
42 2021-01-04 speech disorder Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to spe... Read more
Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to speak. 1120 25mg Benadryl liquid given, Pepcid 20 mg given PO, cough worsening. 1122 second dose of Benadryl given, called for MD. Brought pt to Private room via wheelchair. Upon arrival, audible stridor noted. Epinephrine 0.3 mg IM given at 1126. IV started, placed patient on monitor and O2 via 1L NC. MD at bedside along with RT and pharmacy. 1134 Solumedrol 125 mg IV given, 1 puff of Ventolin given. Lungs clear. 1140 Coughing stopped, pt able to speak now. Vital signs: 1130 SPO2 99% Pulse 142 1135 99% pulse 106 BP 168/102 1140 sats 100% HR 93 BP 157/105 1145 sats 100% HR 97 BP 159/93 1200 sats 99% HR 103 155/97 114
42 2021-01-05 weakness she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from ... Read more
she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown. Information about lot/batch number has been requested.
42 2021-01-05 facial paralysis bells palsy of right eye
42 2021-01-05 flushing had swelling of mouth, flushed face, treated with 50mg of diphenhydramine. symptoms resolved within ... Read more
had swelling of mouth, flushed face, treated with 50mg of diphenhydramine. symptoms resolved within one hour
42 2021-01-05 night sweats vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontan... Read more
vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontaneous report from a contactable Pharmacist, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), intramuscularly in the right arm on 30Dec2020 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included Graves' disease from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing and anxiety from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE), duloxetine (DULOXETINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. On 31Dec2020 at 02:00, the patient experienced vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats. No therapeutic measures were taken as a result of the events. The clinical outcome of the vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats was resolving. It was also reported that since the vaccination, the patient had been tested on 31Dec2020 for COVID-19 with results pending.
42 2021-01-05 pain in extremity Sore arm and fatigue lasting 24 hours. Ibuprofen.
42 2021-01-05 tingling, feeling hot, numbness tingling on left pinky warmth hot sensations moving up towards the cheek cheek and lips went numb
42 2021-01-06 weakness Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fa... Read more
Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fatique
42 2021-01-06 weakness I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vacci... Read more
I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vaccination. After the vaccination, I had a fever for 1.5 days, muscle aches, weakness, nausea, diarrhea, headache, fatigue, cough. I had a rash that appeared after I got COVID-19, the rash never went away. After the vaccination, the rash became redder, enlarged, and spread.
42 2021-01-06 cold sweat chills, cold sweats, diarrhea, muscle aches
42 2021-01-06 discomfort About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of m... Read more
About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of minutes and then passed. Then about 45 minutes after I started to feel a heaviness/ache in my upper chest. This feeling continued for days. Around day four I began to have a feeling of great pressure in my throat, particularly when swallowing. I noticed that my heartrate was elevated, but that might have been because the feeling was very stressful. The feeling would increase when I turned my head to the side or put my chin down.This feeling persisted for 3 days. After three days the feeling changed slightly and started feeling more like the sensation one gets when you have food stuck in your throat. As I type this, it is 8 days after the vaccine and I still feel this sensation in my throat.
42 2021-01-06 facial paralysis patient states started with symptoms of facial paralysis on 12/24/2020 Patient states pain on left s... Read more
patient states started with symptoms of facial paralysis on 12/24/2020 Patient states pain on left side of face and cephalic region on 12/25/2020 and went to ER, where was diagnosed with Facial Paralisis
42 2021-01-06 feeling hot 12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discha... Read more
12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discharged. On 12/24/2020 developed cyanosis to lips. Returned to ED and placed on 5 day steroid therapy and diphehydramine. Mildly improved.
42 2021-01-06 feeling jittery, feeling cold About 1 hr post vaccination, patient developed jittery feeling (like she chugged espresso), cold fee... Read more
About 1 hr post vaccination, patient developed jittery feeling (like she chugged espresso), cold feeling in the chest. Pt reported eating breakfast and being adequately hydrated. Patient returned to vaccine clinic, remained seated for about 30 minutes, drank water, and feeling dissipated.
42 2021-01-06 numbness, weakness, cold extremities Transient weakness, numbness in bilateral lower extremities and cold left arm. Patient rested and s... Read more
Transient weakness, numbness in bilateral lower extremities and cold left arm. Patient rested and symptoms resolved
42 2021-01-06 numbness Left arm and fingers became numb for over 24hours
42 2021-01-06 migraine with aura I had visual aura with migraine which is a normal event for me. This time, however, it was accompani... Read more
I had visual aura with migraine which is a normal event for me. This time, however, it was accompanied by confusion and memory loss that lasted about 15 minutes. I couldn?t say names of people known to me or read a list on my counter. In 25 years of migraines I have never had these symptoms with my migraine. I took an over the counter migraines medicine which resolved the symptoms.
42 2021-01-06 pain in extremity Diarrhea left arm pain; abdominal pain 12/22 - vaccinated 12/23 onset of left arm pain and couldn't ... Read more
Diarrhea left arm pain; abdominal pain 12/22 - vaccinated 12/23 onset of left arm pain and couldn't lift her arm. 12/24 arm pain improved. 12/25 felt normal and healthy 12/26 stomach sharp pain, diarrhea and felt shaky. 12/30 tested negative for COVID-19. 12/31 - symptoms persisted through today and have improved for the first time today. Left with only mild abdominal ache. Not sure the abdominal symptoms are related to the vaccine. She was advised to seek medical care if symptoms persist or worsen.
42 2021-01-06 pain in extremity Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, "I did experience the sor... Read more
Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, "I did experience the sore arm, though mine lasted about a week. I received my vaccine the morning of the 21st and by the evening I was experiencing what I have been called "tantrum moodiness". Short fuse, unreasonably angry, felt like crying, yelling, arguing. By the next day some general malaise that led to aching, especially it seemed in connective tissue. More moodiness, crying, some yelling. By Wednesday it seemed to resolve."
42 2021-01-06 tingling Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Re... Read more
Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Reports palpitations 30 minutes post vaccine. Unknown duration as per patient.. Patient denies any palpitations, chest pain, or shortness of breath at time of phone interview. At about 9pm on the day of vaccine patient reports a rash all over her body. Describes it as bumpy and very itchy, getting worse. Patient reports taking Benadryl. States it helped with the itching but rash is continuing to spread. Denies respiratory complaints at time of phone interview. Patient instructed to see her provider as soon as possible for evaluation and treatment.
42 2021-01-07 weakness 1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and a... Read more
1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and aspirin. 1100 to 01/07/2021, 0200 severe lethargy lasting till around this time. Heart rate excess of 130, dizziness, severe weakness, muscle pain, fever 103 to 104 F. 650mg oral Tylenol and aspirin 325mg every 6 hours does not control temp. Intermittent periods of extreme perspiration. 0200 1/07/2021 to 1200, slow decline in body pain with ongoing Tylenol and aspirin every 6 hours. No more elevated temps. Injection site/arm remains painful.
42 2021-01-07 feeling hot, flushing Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side o... Read more
Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side of her tongue became tingly. The rapid assessment team responded and noted her blood pressure was 186/103 and pulse was 146 and she had a headache. They had her rest for about 45 minutes and she felt better. Her blood pressure came down to 130/90 and pulse was 100. On 01/07/20 she still is experiencing a headache and body aches. She has never felt short of breath.
42 2021-01-07 nerve pain Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache le... Read more
Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; This is a spontaneous report from a non-contactable nurse. A 42-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 19Dec2020 11:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient experienced deep ache left deltoid at injection site with severe nerve pain when lifting left arm on 23Dec2020 16:30. The patient received no treatment. The outcome of the events was not recovered.
42 2021-01-07 pain in extremity ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECT... Read more
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. CURRENTLY AWAITING INSTRUCTIONS FROM PRIMARY PROVIDER.
42 2021-01-07 pain in extremity ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SI... Read more
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SITE WHICH IS WARM TO THE TOUCH. AS OF THIS REPORTING IS AWAITING A CALL FROM HER PRIMARY PROVIDER.
42 2021-01-07 pain in extremity I woke up on 1/8/20 at 2:00 am with my left arm hurting badly. I felt feverish, chilled, with a hea... Read more
I woke up on 1/8/20 at 2:00 am with my left arm hurting badly. I felt feverish, chilled, with a headache and full body muscles aches. I checked my temperature at 7am and it was 100.5 oral. I could barely get out of bed all day. My temperature peaked at 101 despite taking 400mg of Ibuprofen at 9am. It is currently 8 pm on 1/8/20 and I still have a fever, muscle aches, headache and fatigue.
42 2021-01-07 pain in extremity ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTIO... Read more
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. AT THIS TIME AWAITING FURTHER DIRECTION FROM PRIMARY PROVIDER.
42 2021-01-07 pain in extremity whole body ached/shingles like pain in my butt/legs/groin to where my skin hurt to touch it/pain was... Read more
whole body ached/shingles like pain in my butt/legs/groin to where my skin hurt to touch it/pain was excruciating/the vaccine amplified the pain; sore arm; progressed to Flu like symptoms; Arthritis in her knee/vaccine amplified the pain; This is a spontaneous report from a contactable healthcare professional. A 42-year-old female patient received bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; lot number: EH 9899; expiration date: unknown), intramuscular left arm on 30Dec2020 20:30 at a single dose for covid-19 vaccination. Medical history included arthritis in my knee, labrum hip tear, HSV2 (herpes simplex virus type 2), haven't had an OB [pending clarification] in over 2 years and herpes. Concomitant medication included omeprazole (PRILOSEC), ondansetron (ZOFRAN MELT), alprazolam (XANAX; reported as Xanax ER), lamotrigine (LAMICTAL), famotidine (PEPCID AC) , colecalciferol (VITAMINS D3; reported as vitamin D), ascorbic acid (VIT-C) and zinc. The reporter stated that after the vaccine (31Dec2020 12:00), the patient had a sore arm and it progressed to Flu like symptoms and pain in her joints. Her whole body ached. The patient mentioned that she has arthritis in her knee and a labrum hip tear, and the vaccine amplified the pain. She also has HSV2 and she haven't had an OB in over 2 years, and she had a bad OB and shingles like pain in her butt/legs/groin to where her skin hurt to touch it. The pain was excruciating. The patient did not received treatment for the adverse event. The patient considered the event as non-serious. She received the COVID-19 vaccine in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.
42 2021-01-07 tingling, tenderness 3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint... Read more
3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.
42 2021-01-07 tingling Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination -... Read more
Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination - bleeding at the injection site which the employee reports as filling the bandaid over the site. When she got home in the evening and took it off blood ran down her arm but the bleeding stopped immediately. This has resolved. 12/29 at about 2:00 employee reports onset of tingling in the fingers of her right hand - index, middle, ring, and pinky. For about 2 hours the tingling was intense. As of 12/30 this has markedly improved and the tingling is intermittent. Later in the evening of 12/29 she noticed the onset of muscle pains throughout her body but especially in her feet. She also became very fatigued. These symptoms linger on 12/30. On 1/1 employee reports symptoms muscle soreness had resolved. 1/4 tingling in her fingers/arm has improved but is still present. She will follow-up with her PCP if this symptom persists beyond 2-4 weeks.
42 2021-01-07 tremor Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin;... Read more
Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin; mild headache lasting 1 day; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730, intramuscular on Right arm from 22Dec2020 09:45 to 22Dec2020 09:45 as single dose for COVID-19 immunization. Medical history included hypertension, and glaucoma. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), fluticasone propionate (FLONASE), and latanoprost (XALATAN). On 24Dec2020 08:30 am, the patient experienced fever up to 100.8 (unknown unit), chills, shaking, general muscle aches, generalized sensitive skin, mild headache lasting 1 day. The patient was not tested for Covid post vaccination. The patient is not pregnant. The outcome of the events was recovered on 25Dec2020. No treatment was received for the events.
42 2021-01-08 weakness, pain in extremity The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the ... Read more
The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the night with pain. The day after: moderate to severe pain on the left arm that radiates to the neck and back. Took Ibuprofen in the morning. Pain was getting better as the day pass. At night, around 6 pm started to feel that something is not OK. I am not the same as before. My legs are not very strong (feeling it, not a problem that I can?t walk - it feels like). Feeling dizzy at times. Went to bed and pain on the left arm is much better. Two days after the vaccine: woke up with body aches, feeling dizzy at times, weak, nauseous. Not feeling OK. It is now around11:30 am two day after the vaccine and I am starting to get worried. Please contact me for advise. Thanks
42 2021-01-08 pain in extremity 2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp w... Read more
2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp with while alternating Tylenol/Advil q4h, large swollen lump in armpit and below clavicle which are extremely painful (on side of body where vaccine was administered). Stiff neck and jaw, severe headache, mild dizziness (was much worse after the 1st dose), nausea, fatigue.
42 2021-01-08 tingling Employee c/o tingling lips up to bottom of the nose.
42 2021-01-09 feeling cold, pain in extremity Sore arm, cold chills, irritable skin all over, achy muscles, headache
42 2021-01-09 feeling hot Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions an... Read more
Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.
42 2021-01-09 tingling, weakness, pain in extremity Pain and tingling in entire left arm, severe chills, bluish lips, weakness, fatigue, headache, muscl... Read more
Pain and tingling in entire left arm, severe chills, bluish lips, weakness, fatigue, headache, muscle and joint pain.
42 2021-01-10 difficulty speaking Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 mi... Read more
Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 minutes without intervention. Remained in the observation room symptom-free for additional 30 minutes. At home, symptoms of shortness of breath and chest tightness returned and worsened. Throat felt tight, able to move air, however had trouble swallowing. Voice was raspy and increased coughing. From past experience with allergy shots, this was my cue to use epi pen. Within 5 minutes after using epi pen, all symptoms were resolved.
42 2021-01-10 facial pain, migraine, facial paralysis Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergenc... Read more
Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) intramuscular, on 17Dec2020 04:15, single dose arm left for COVID-19 immunization. Relevant medical history included hypothyroidism, hypertension, hyperlipidemia, obesity, and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), butalbital, caffeine, paracetamol (FIORICET 50-40- 325mg), dexamethasone 4mg Inj., diclofenac (VOLTAREN 1% Gel), Magnesium, valsartan (VASOFLEX) (pending confirmation), cyanocobalamin (VITAMIN B12), losartan potassium. The patient was not pregnant and did not received any vaccine in four weeks. The patient previously took cephalosporin and experienced allergy. On 24Dec2020, the patient experienced pain left side of the face and migraine, and came to emergency room where apparently they diagnosed facial paralysis. The events resulted in emergency room visit/ urgent care where the patient was administered dexamethasone 4mg Inj, Medrol dose pack, Vit B12 500mcg, and Fioricet 50-325-40. Facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. It was unknown if the patient was diagnosed with COVID-19 prior or since the vaccination. The events were assessed by the nurse as non-serious. Outcome of the events was recovering at the time of the report.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
42 2021-01-10 feeling hot Left axilla pain, left outer arm red, hot, firm.
42 2021-01-10 flushing After 15 minute waiting period, patient returned to work in healthcare system, reported flushing and... Read more
After 15 minute waiting period, patient returned to work in healthcare system, reported flushing and difficulty swallowing. Patient presented to emergency department.
42 2021-01-10 pain in extremity, night sweats Bone deep body aches in back and legs, sweats like I had a fever that drenched the bed sheets, and f... Read more
Bone deep body aches in back and legs, sweats like I had a fever that drenched the bed sheets, and fatigue. I slept most of the day on Sunday after getting the shot the day before. I never checked my temperature to tell if I had a fever. The night sweats continued into sunday night. I took 600mg of advil for the body aches and went to bed. When I woke up around 1:00 in the afternoon the body aches were gone and haven't returned. Sunday night I was sweating most of the night and felt over heated until around 11:00 Monday morning. I am always cold, I am the type who wears sweaters in the house all year long. For me to be that hot in the house is very unusual.
42 2021-01-10 pain in extremity Fever up to 102 degrees, severe body aches, uncontrollable shivering, lymphadenopathy, right arm pai... Read more
Fever up to 102 degrees, severe body aches, uncontrollable shivering, lymphadenopathy, right arm pain
42 2021-01-10 tingling "I received the first dose in my right deltoid on 12/22/20, and started feeling tightness, tingling,... Read more
"I received the first dose in my right deltoid on 12/22/20, and started feeling tightness, tingling, and pain in my right shoulder and neck. It steadily progressed, and by the morning of 12/25/20, I had almost no range of motion in my neck and right shoulder, and severe pain in my right shoulder/neck/upper back area (heat/ice/ibuprofen/Aleve/Tylenol offered zero relief) . This lasted for a few days, then steadily improved until I returned to work on 12/28/20, where I had mild-moderate pain and most of my range of motion had returned. I still feel like the muscles in my neck and shoulder are tight, but I?m doing stretching exercises with heat/ice at home and it seems to be working its way out. The other symptoms were expected and mild: fever, muscle/joint aches, fatigue. These symptoms come and go ? I?ve had them since being COVID positive in March/2020. Just to be extra safe, I was swabbed for COVID on the 30th and was negative."
42 2021-01-11 weakness Flu like symptoms, syncope, lymphadenopathy, nausea, fatigue, weakness.
42 2021-01-11 feeling hot became hot and sweaty in monitoring room. Stayed for 30minutes in monitoring room and symptoms reso... Read more
became hot and sweaty in monitoring room. Stayed for 30minutes in monitoring room and symptoms resolved and colleague returned to department to resume work. Symptoms re-occurred
42 2021-01-11 flushing Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush fa... Read more
Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush face
42 2021-01-11 numbness, tingling Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face... Read more
Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face, burning of the eyes, and a metallic taste was noticed in the mouth. However, all of these sensations went away on their own within five minutes of onset, without any intervention.
42 2021-01-11 migraine Migraine started at approximately 7:30pm and lasted through midday Saturday. Migraine was intense e... Read more
Migraine started at approximately 7:30pm and lasted through midday Saturday. Migraine was intense enough for me to have to call off sick from work on Friday.
42 2021-01-11 muscle spasms headache starting 1 hour after the injection and persists until present day, 1/12/21. Severe spasm l... Read more
headache starting 1 hour after the injection and persists until present day, 1/12/21. Severe spasm left trapezius muscle on same side as injection. I discussed by symptoms with my PCP and he advised I report as an adverse reaction.
42 2021-01-12 inability to speak, pain in extremity Sore arm -24 hours Extreme fatigue 8 hours Brain fog Difficulty forming words physically Difficul... Read more
Sore arm -24 hours Extreme fatigue 8 hours Brain fog Difficulty forming words physically Difficulty coming up with words to use Exhaustion
42 2021-01-12 weakness weakness, breathlessness, pain at sight, body aches over two days I am not feeling better yet
42 2021-01-12 discomfort Tingling of the tongue, heaviness began at 13:30 p.m., 50 mg Benadryl given at 13:35, BP 110/70, BPM... Read more
Tingling of the tongue, heaviness began at 13:30 p.m., 50 mg Benadryl given at 13:35, BP 110/70, BPM-108 14:00 p.m. symptoms continuing, symptom improvement beginning at 13:00 p.m.
42 2021-01-12 pain in extremity, numbness 1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted thro... Read more
1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted throughout the day. 1/9/21 - I woke up at 4am the follow day after receiving the vaccine and my left side of my face was numb, I could still taste metal in my mouth, I had a headache and pain in my right arm. I watch my symptoms and checked to see if I was having a stroke, but nothing pointed to that. 1/10/21 - I still was experiencing the same symptoms from 1/9/21 with not increased or decreasing of symptoms. Watched them throughout the day but nothing changed. 1/11/21 - I continued to have the same symptoms and reported to the ED after work for the symptoms listed above with no improvement. 1/12 & 1/13 - I continue to have the same symptoms with no changes.
42 2021-01-12 pain in extremity 1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 ... Read more
1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 hours. After 2nd injection on 1/10/21, I had soreness at R arm, fatigue on first day. 2 days after 2nd injection, I developed rash/swelling around both eyes, and on 3rd day had worse eye symptoms and rash across upper chest. I called employee health and my PCP to report symptoms.
42 2021-01-12 pain in extremity Sore arm nausea fatigue 24-48 hrs. after vaccine administration. Today 1/13/2021- tested covid posi... Read more
Sore arm nausea fatigue 24-48 hrs. after vaccine administration. Today 1/13/2021- tested covid positive via PCR swab.
42 2021-01-12 pain in extremity About ten minutes after administration I began to feel prickly, burning on my arms which gradually g... Read more
About ten minutes after administration I began to feel prickly, burning on my arms which gradually got worse over the next 20 minutes and spread to my hands, sides, back and legs. Arms were very red. Informed clinic medical provider who took vitals. blood pressure was 186/116 o2 sat were normal. was given an im shot of benedryl and water, vitals were continued to be monitored and blood pressure came down to 145/84. Prickly burning sensation and redness continued. Went home and examined body and did have several hives on back and upper arm. slept due to benedryl, woke up to a very sore arm, achy joints but the prickly burning had mostly resolved. next day still feel tired and achy in joints but burning is gone.
42 2021-01-12 tingling, paralysis 10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation st... Read more
10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation started from my left arm and radiated to my whole body. The sensation was very intense it felt like my whole body was being paralyzed. I was fading out because of high heart rate. My heart rate was 160 and I heard someone said my blood pressure was high. I was transferred to the ER and given epinephrine, anti-histamine, steroids.
42 2021-01-12 tingling, speech disorder, throat numbness 2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep chok... Read more
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
42 2021-01-12 tingling Patient initially experienced tingling in left hand right after injection. This resolved but then sh... Read more
Patient initially experienced tingling in left hand right after injection. This resolved but then she began to have tingling in her lips. Then she had tingling at the tip of her tongue and then her neck began to feel stiff. Her blood pressure also rose to 145/72. Her baseline BP is usually 96/69. She was administered 02.ml epinephrine subcutaneously, Then when her lip tingling did not resolve, Benadryl 50mg IM injection was given. After 2 hours of observation, her symptoms resolved and she was released to go home. No ER visit was necessary.
42 2021-01-13 weakness Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a st... Read more
Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.
42 2021-01-13 weakness Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when g... Read more
Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when going to bed. Overnight, I started to experience chills followed by extreme perspiration and weakness to the point that I struggled to open a bottle of water I had by my bed. Tuesday, 1/12/2021: Headache, weak and tired but attempted to work. I had to leave shortly after arriving because my symptoms were becoming progressively worse to the point I almost passed out from standing. Upon arriving home, I started to experience nausea and vomiting x 3. Intense chills followed by the extreme perspiration still existed. Most of these symptoms subsided by 9:30p that evening. Wednesday, 1/13/2021: Intense headache, weakness and dizziness. Of note, my left underarm/armpit (the arm where the vaccine was administered) is sensitive to touch.
42 2021-01-13 cold sweat Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facia... Read more
Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facial swelling around eyes.
42 2021-01-13 difficulty speaking reported hoarseness in the voice; itching and burning sensation around the throat; shortness of brea... Read more
reported hoarseness in the voice; itching and burning sensation around the throat; shortness of breath; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 17:00 at single dose in the right arm for COVID-19 immunisation. The patient had anaplasias to penicillin and COVID. The concomitant medications was none. The patient experienced hoarseness in the voice on 07Jan2021, itching and burning sensation around the throat in Jan2021. She had shortness of breath in Jan2021 related to COVID-19 infection. She has had COVID already so she isn't worried about that but wants to know if it is related to the vaccine or not, if this is something she needs to be aware of. The event started and gradually was getting worse. She had her inhaler from when she had COVID. The patient clarified she has also had some shortness of breath but this has been going on since having COVID. She did try the inhaler for the hoarseness and shortness of breath she had. She has been interment shortness of breath since having COVID and she is being tested for lung damage. The inhaler didn't change the hoarseness or shortness of breath. The product used was salbutamol (ALBUTEROL), Lot: PK0358, Expiry: Jun2022, NDC: 0093317431. She has had no reactions to vaccines previously, she had no vaccines on the day of or in the previous 4 weeks. She has not been to the doctor or ER related to the event. The outcome of the event hoarseness in the voice was not recovered. The outcome of other events was unknown.
42 2021-01-13 flushing, feeling hot 1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with e... Read more
1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal
42 2021-01-13 numbness, burning sensation Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (... Read more
Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (1/13/21)on the left armpit and later on axillary lymph edema(1/14/21)and heaviness of the arm. Itching and joint pain on left arm. Muscle pain ,cold and injection site pain since the evening of 1/12/21.
42 2021-01-13 numbness, tingling acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling ... Read more
acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
42 2021-01-13 pain in extremity Patient reports soreness to the arm, she has a lymph nodes are the size of a "golf ball". This is o... Read more
Patient reports soreness to the arm, she has a lymph nodes are the size of a "golf ball". This is on the right side. No other findings
42 2021-01-13 cold extremities, pain in extremity headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this o... Read more
headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-13 tremor Exactly 15 hrs post injection I woke with uncontrollable shakes, fever 101.6, vomit x4, nausea, Bone... Read more
Exactly 15 hrs post injection I woke with uncontrollable shakes, fever 101.6, vomit x4, nausea, Bone pain especially neck, lower back and hips, headache and congestion.
42 2021-01-14 cold sweat I experienced injection site pain in the left upper arm which seemed intense. I woke up at 0100 wit... Read more
I experienced injection site pain in the left upper arm which seemed intense. I woke up at 0100 with severe body aches, cold sweats and shivering. It was hard to walk the body aches were horrible. I checked my temp and it was 100.3 F
42 2021-01-14 feeling hot After second vaccine: light-headed, chills, hot, muscle aches, headache, light feeling
42 2021-01-14 flushing, feeling hot 10min post vaccine, patient reported feeling flushed, hot, and sweaty. No SOB nor difficulty breath... Read more
10min post vaccine, patient reported feeling flushed, hot, and sweaty. No SOB nor difficulty breathing. BP 132/82 normally 110/60s. HR 70. 30 min post vaccine, palms felt itchy and slightly more sweat but overall improved. Within the hour, symptoms resolved and patient returned to work
42 2021-01-14 numbness I had 100.2F at night and significant chills and fatigue and my fever went on until Thursday. I had ... Read more
I had 100.2F at night and significant chills and fatigue and my fever went on until Thursday. I had a pretty big immune response. the right side of my face got numb into my neck and my chest and I feel my lymph nodes turned into marbles. I also have swelling in my lymph nodes, my neck and my back. I sought medical care on Thursday due to the swelling and my PCP does not have a clue what to do.
42 2021-01-14 numbness from patient: I got my 1st dose and waited the 15 minutes, feeling fine. When I got in the car and s... Read more
from patient: I got my 1st dose and waited the 15 minutes, feeling fine. When I got in the car and started driving home I began to notice that my face was slightly numb (Iike I'd had too much novicaine). This was maybe 20-25 minutes after the dose. When I was home I also noticed that the back of my throat felt a little swollen. This probably lasted for a couple hours.
42 2021-01-14 pain in extremity SORE ARM
42 2021-01-14 tingling, numbness, burning sensation Burning , tingling of arm down to left leg. Burning on back of torso. Numbness down left arm and leg
42 2021-01-14 tingling 5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Conti... Read more
5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.
42 2021-01-14 tingling After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Conti... Read more
After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.
42 2021-01-14 tenderness Swelling red tender and very itchy.
42 2021-01-14 tenderness After normal soreness at the injection site, she started with tenderness under in the axillary area.... Read more
After normal soreness at the injection site, she started with tenderness under in the axillary area. States no change in skin; however, is tender to palpate or to have clothes rubbing
42 2021-01-15 feeling hot, feeling cold, tingling, pain in extremity, numbness, muscle spasms Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fl... Read more
Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fluttering? muscle spasms in deltoid 1330 numbness, tingling, muscle spasms in deltoid; 6/10 burning pain in upper arm/armpit, woozy/lightheaded 1345 driving home same as above, nausea, noticed more nasal congestion, post nasal drip 1400 increased nausea, increased symptoms in shoulder/armpit, 4/10 painful deltoid...soreness, burning pain; had a snack 1430 increased severity of symptoms 5-6/10 pain, weird numb feeling in shoulder, itchiness increased; took Tylenol 1530 increased nausea and now chills, cold, shooting cold pain left neck, neck/shoulder stiffness, intermittent ?fluttering? of heart but only for a few seconds (<15sec) 1615 5/10 worsening pain in L dorsal lower arm 1730 increased nausea, chills, cold shooting pain still present intermittently, numbness extends to medial & lateral upper arm 4-5inches from biceps tendon insertion 1830 feeling a little better after eating 2100 overwhelmingly tired, significantly less numbness and tingling, 6/10 pain/soreness in Left deltoid, stretched, took Tylenol, noticeable increase in nasal congestion, post nasal drip, no trouble breathing or cough, temp 97.5F 2200 increased L shoulder pain/muscle tightness, numbness gone, replaced by armpit 4/10 tenderness upon light palpation, alternating between chills and clamminess, feel really ?hot? despite oral temp 97.5F 01/16/2021 0100 6/10 shoulder pain/tenderness/stiffness, armpit significantly less tender 1/10, significantly less numbness or cold, shooting pain; feel really hot, almost sweating despite room temp 68F and oral temp 97.3F ?totally awake? 0130 got up, void x1, made chamomile tea, took 10mg melatonin, 500mg Tylenol, a ?little nauseated? 0800 woke up, 6/10 constant pain in left deltoid, no numbness, tingling or cold sensations 0830 Took Tylenol with breakfast and rest of vitamins 1200 increased pain (6/10) in L deltoid, mild nausea; increased lightheadedness, fatigue, and ?achy? feeling throughout body. 1230 Took Tylenol 1300 pain 5/10, mild nausea, and lightheadedness, but increased fatigue and ?achy? feeling throughout body 1700 mild/moderate constant pain in L deltoid, mild nausea, fatigue, achy feeling 1800 tookTylenol with dinner 2000 increased fatigue, mild achy feeling and chills, no nausea 2200 increased nausea, 5/10 constant pain in L deltoid Took Tylenol 500mg and went to sleep.
42 2021-01-15 tremor Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, sh... Read more
Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, shortness or breath, muscle stiffness all over and muscle weakness, nausea
42 2021-01-16 muscle spasms 1/11/21Insomnia - Went to bed by 9pm (woke up 11:30 pm and did not sleep through the night) 1/12/202... Read more
1/11/21Insomnia - Went to bed by 9pm (woke up 11:30 pm and did not sleep through the night) 1/12/2021 Muscle spams (neck) - body ached, lethargy - Took Tylenol 1/12/2021 Headache (sinus pressure) started fading at around 8 pm 1/13/2021 Lightheaded 1/14/2021 Lightheaded 1/14/2021 back to normal
42 2021-01-16 pain in extremity, weakness Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the mor... Read more
Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the morning of 1/14/21. Pain got steadily worse to the point of full body myalgias, severe fatigue/weakness and severe nausea. Almost passed out at work and ended up being bedridden for the rest of the day on 1/14 and all day 1/15 and 1/16. Also had hematuria that developed on 1/15. Went to urgent care clinic on 1/16 and received one bag of IV fluids and zofran for the nausea. CBC, CK, CMP all normal but 1+ hematuria on U/A. Symptoms finally improved on 1/17
42 2021-01-16 pain in extremity, numbness, tingling "I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I... Read more
"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I awoke with chills and sweats. No fever. Felt crummy all day. Today I have left shoulder and arm pain, swelling in my left armpit and under my arm. I also have some numbness and tingling through my arm down to my hand. I have a hard knot at the injection site but its not red. I also continue to have occasional chills."
42 2021-01-17 bell's palsy Left sided Bells Palsy.
42 2021-01-17 feeling hot AFTER INJECTION PATIENT FELT WARM SENSATION IN HER TORSO. PATIENT ALSO STATED SHE HAD A HEADACHE, NA... Read more
AFTER INJECTION PATIENT FELT WARM SENSATION IN HER TORSO. PATIENT ALSO STATED SHE HAD A HEADACHE, NAUSEA AND BOIDY PAIN. PATIENT WAS PALE WHEN PLACED IN AMBULANCE AND GIVEN OXYGEN AND HAD HER FEET ELEVATED. PATIENT WAS IN AMBULANCE FOR ABOUT 25 MINUTES AND COLOR DID NOT COME BACK TO NORMAL EVEN AFTER THE OXYGEN ADMINISTRATION. THE PATIENT WAS ADVISED AND CONVINCED TO ALLOW THE AMBULANCE TO TRANSPORT HER TO HOSPITAL TO BE ASSESSED WHICH SHE AGREED TO. I CALLED THE PERSON ON 1/17/2021 @ 8:54 PM AND SHE STATED THAT SHE STILL FEELS A LITTLKE UNDER THE WEATHER BUT IT HAS GOTTEN BETTER
42 2021-01-17 flushing Pt was given Pfizer vaccine dose #1 and patient's face became flushed within 1 minute of administrat... Read more
Pt was given Pfizer vaccine dose #1 and patient's face became flushed within 1 minute of administration. Pt has hx of multiple allergies. Pt was asked to take mask off and redness subsided within 5 mins. Pt then reported having numbness/tingling in tongue and lips. Pt was monitored for a total of 36 minutes per RN. Pt reported no further symptoms and noted improvement of symptoms. She was discharged to home with husband, who was also present for the event.
42 2021-01-17 numbness, weakness, muscle twitching, nerve pain, tingling couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind... Read more
couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind eyes/eyes hurt; icreamed; Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off; Whole body still weak; sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips; Twitching of face when do certain movements; brain zaps and brain buzzing began; numbness to right side of face to neck/made its way to left side; Horrible headache; fatigue; felt pressure behind her right eye; felt in a fog; forgetful mid conversation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, EL0140), intramuscular on 23Dec2020 08:00 at single dose at right arm for COVID-19 immunization; prednisone via an unspecified route of administration from an unspecified date to an unspecified date (for 4 days) at 50 mg for an unspecified indication. Medical history included Known allergis: latex, contrast dye. Concomitant medication included the first dose of influenza vaccine (FLU) on 30Nov2020 at single dose at right arm for immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Day 1: on 23Dec2020 08:15, the patient felt pressure behind her right eye after shot, felt in a fog, forgetful mid conversation. Day 2. (24Dec2020) Horrible headache started, fatigue. Day 3 (25Dec2020) brain zaps and brain buzzing began, headache, fatigue, numbness to right side of face to neck. By day 5 (27Dec2020) made its way to left side. Twitching of face when do certain movements. Her Dr gave her Prednisone and she took 50 mg for 4 days and stopped because she couldn't differentiate the tingling in hands and feet from shot or from that. Still brain zaps, newest issue sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips. Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off. Whole body still weak, eyes hurt. Head a lot better than a day ago but still having buzzing and twitching. Today was day 18. She was awaiting an MRI with contrast on Friday hoping it got moved sooner as she was scared to what was going on. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included CT/MRI/Optic Nerve Scan/Pain Shot/Meds for Zaps. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 28Dec2020. The action taken in response to the events for prednisone was permanently withdrawn on an unspecified date. The outcome of the events reported as not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all these reported serious events might not be fully excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-17 numbness, tingling PATIENT AFTER RECEIVING VACCINE AND WAS AT THE WAITING AREA FELT SOME TINGLING AND NUMBNESS IN HER F... Read more
PATIENT AFTER RECEIVING VACCINE AND WAS AT THE WAITING AREA FELT SOME TINGLING AND NUMBNESS IN HER FACE ON THE LEFT SIDE. THE PATIENT WAS ASKED IF SHE WAS HAVING ANY TROUBLE BREATHING AND SHE SAID NO. PATIENTS VITAL SIGNS WERE TAKEN OVER A PERIOD OF AN ADDITIONAL 30 MINUTES OF WAIT TIME. AFETR THE 30 MINUTES THE VITAL SIGNS WERE TAKEN AGAIN AND FOUND TO BE NORMAL AND THE PATIENTS TINGLING AND NUMBNESS SUBSUSIDED. SHE DID NOT WANT TRANSPORT TO HOSPITAL AND SIGNED AN RMA. PATIENT WAS ASKED TO CALL WHEN SHE GOT HOEM AND A CALL WAS RECEIVED AT 12:03 AM FROM THE PATIENT WHO ALSO STATED SHE TOOK BENADRYL.
42 2021-01-17 migraine Elevated BP with migraine headache. BP 160/104, HR 106. Reported- visited doctor and BP returned to... Read more
Elevated BP with migraine headache. BP 160/104, HR 106. Reported- visited doctor and BP returned to normal.
42 2021-01-17 tingling Employee reported palpitations 5 minutes after vaccine was administered then began having rash on ch... Read more
Employee reported palpitations 5 minutes after vaccine was administered then began having rash on chest and tingling in lips and face. Benadryl 25mg and Epi-pen were administered. Symptoms got better and employee went home. Had to go back to Emergency Room for tingling all over and flushing to face.
42 2021-01-18 burning sensation mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; Thi... Read more
mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; This is a spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 08Jan2021, 10:45 AM on Right arm at single dose for covid-19 immunisation. Medical history included juvaderm under her eye approximately 1 year and half to two years ago. Prior to vaccination, the patient did not diagnose with COVID-19. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 42-year-old on an 18Dec2020, 11:15 AM on Right arm at single dose for covid-19 immunisation. Day after the 2nd dose, the patient had a mild rash around her left eye only on 09Jan2021. 3rd day (11Jan2021) swelling to the eye. The day of this report is 4 days post vaccine (12Jan2021), the patient mild redness mild swelling but remain itchy and burning. The patient did not report to her dr as the symptoms seem to be resolving on its own. No covid tested post vaccination. No treatments were received. Outcome of the events was recovering. Information on the lot/batch number has been requested.
42 2021-01-18 feeling cold Patient was administered 2nd vaccine on 1-8-21 by a nursing student. During 15 observation period, ... Read more
Patient was administered 2nd vaccine on 1-8-21 by a nursing student. During 15 observation period, arm began to feel cold at injection site area. At that point the patient realized the vaccine was given toward the back of upper left arm near the fatty tissue instead of toward the middle of the arm. Approximately 20 min after vaccine administration, patient became short of breath, dizzy, light headed, and throat felt a little swollen and almost passed out. A rapid response was called and the patient was seen by Occupational Health. The patient's BP and heart rate were elevated but normalized during observation in Occupational Health. At this time, the patient did not feel they needed to be seen in the emergency department. The patient was discharged home at this time. 12 hours after the shot, the patient began experiencing normal side effects from the vaccine. The nursing student was informed of administration at the incorrect site.
42 2021-01-18 feeling hot Every time I stood up, my heart rate went up into the 120's and I felt an intense pressure in my che... Read more
Every time I stood up, my heart rate went up into the 120's and I felt an intense pressure in my chest. I felt like I couldn't breathe. All day that day I has also experienced feeling hot but I never got a fever. The chest pressure last for a few hours every time I tried to get up. I had a couple of minor episodes over the next 2 days where my heart rate went into the 120's and I felt slightly short of breath but no pressure.
42 2021-01-18 tingling c/o tingling of face and tongue, metallic taste
42 2021-01-18 cold extremities Fever 101.8, sore throat, drowsy, severe malaise, achy joints, shivering, head ache, cold hands and ... Read more
Fever 101.8, sore throat, drowsy, severe malaise, achy joints, shivering, head ache, cold hands and feet
42 2021-01-19 weakness, pain in extremity Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid... Read more
Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid heart rate, metallic taste in mouth. weakness, fatigue, Symptoms still current after 2 weeks post vaccine.
42 2021-01-19 weakness within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all ov... Read more
within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all over & I asked for Benadryl. I was taken to the ED dept. I was given zofran 4mg and Meclizine for vertigo and IV after 4 hrs. I Was told to go home and sleep it off. I've home with joint pain, muscle aches, nausea, abdominal pain, foggy mind, tiredness, weakness. Saw my PCP today. Rest, zofran and meclizine PRN hydration and rest.
42 2021-01-19 weakness Intense chills onset about 12h after vaccine and lasted for 3-4 hours, with a max temp of 101.2 tha... Read more
Intense chills onset about 12h after vaccine and lasted for 3-4 hours, with a max temp of 101.2 that lasted around another 20 hours. Muscle aches, weakness, fatigue and decreased appetite for duration of fever. Took excedrin for severe headache once fever broke. Symptoms completely resolved 12h later, after sleeping.
42 2021-01-19 numbness, bell's palsy EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting... Read more
EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
42 2021-01-19 migraine Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until... Read more
Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until it passed. Day 6, another migraine. Ibuprofen and caffeine. Day 7 I went to get a haircut thinking the migraines may be caused by heavy long hair. Day 8 extremely painful migraine, can?t open eyes as light made it worse, nausea, vomiting. Called my PCP, they recommended going to urgent care after I vomited. I couldn?t get a ride so I took ibuprofen, Tylenol, and hydroxyzine to help me sleep until it?s gone.
42 2021-01-19 pain in extremity arm pain for 5 days, nausea for a day or two then came back, on going dizziness and headache. Treat... Read more
arm pain for 5 days, nausea for a day or two then came back, on going dizziness and headache. Treated with ibuprofen, Tylenol, Zofran which has helped some, but all comes back and now for 2 weeks.
42 2021-01-19 pain in extremity When went from sitting to standing position noticed pain/numbness on bottom of left foot. When wen... Read more
When went from sitting to standing position noticed pain/numbness on bottom of left foot. When went to walk, pain shot up through foot with each step, making it difficult to walk. This lasted for approximately 35 feet before resolving.
42 2021-01-19 throat numbness, sensory loss, involuntary muscle movements, numbness About 20 min after receiving my Covid 19 vaccine, I left Hospital and began to feel numb in my throa... Read more
About 20 min after receiving my Covid 19 vaccine, I left Hospital and began to feel numb in my throat, my lower face, and the tops of my shoulders. I had reduced sensation, but also felt as though I had no muscle control with movement. Examples of this are when I tried to flex my head forward as if in a nodding motion, or to elevate my shoulders like a shrug, or clench my jaw like when chewing. These were all extremely difficult and I felt as though I had no awareness of if I was even moving these parts of my body whatsoever when I tried to voluntarily do so. It was very strange and also upsetting. I also began to have blurred vision; it was difficult to focus or see properly, such as when you visit the eye doctor and they dilate your pupils and everything seems blurry and out of focus for a period of time afterwards. This all lasted for about exactly 1 hour post. I did not seek medical attention for this as it did not worsen. I never had any difficulty breathing. It then completely went away.
42 2021-01-20 weakness, pain in extremity pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and ... Read more
pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and legs (the feeling that inside the legs are stiff).; woke and I was nauseus.; Pain is radiating to back and neck/I can't bend over that I feel pain from the neck to the head on the left side only.; I started to feel a little weaker, body aches.; I started to feel a little weaker, body aches.; unable to lift arm completely; Pain is radiating to back and neck; sore left arm after couple hours; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 07Jan2021 11:45 at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was NKA/NKDA. Concomitant medication included methylcellulose (CITRUCEL), ergocalciferol (VIT D), vitamin b complex (B-COMPLEX), ubidecarenone (COQ 10) and birth control. The patient was not pregnant at the time of vaccination. The patient experienced sore left arm after couple hours on 07Jan2021 18:00. At night took Ibuprofen to help with pain. Pain woke the patient up at night. On 08Jan2021, left arm was very sore, unable to lift arm completely. Pain was radiating to back and neck. Took Ibuprofen. At night she wasn't feeling the same. She started to feel a little weaker, body aches. Her legs felt strange, as if there was some pressure, that veins were stiff. On 09Jan2021, the patient woke and was nauseas. Arm was not very sore but neck was. She couldn't bend over that she felt pain from the neck to the head on the left side only. At night her legs started to feel the pressure again. It seemed like pain on the joints. She didn't feel the same. On 10Jan2021, woke up with pain on the joints, and legs (the feeling that inside the legs were stiff). She was afraid that she was having an unusual, serious reaction and not aware of it. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
42 2021-01-20 facial pain, facial paralysis Acute Bell's Palsy right side occurring on 1/16/2021, total right sides facial palsy involving eyeli... Read more
Acute Bell's Palsy right side occurring on 1/16/2021, total right sides facial palsy involving eyelid, mouth, decreased salivary secretion, facial, ear, mastoid pain. Started prednisone 60mg daily and Acyclovir 400mg po 5x/day on 1/17/2020 x 1 week course. No improvement since onset.
42 2021-01-20 feeling cold Fever, chills, body aches, nausea
42 2021-01-20 hypersensitivity of all senses minor allergic reaction; small hives on her thumb; skin was sensitive; This is a spontaneous report ... Read more
minor allergic reaction; small hives on her thumb; skin was sensitive; This is a spontaneous report from a contactable consumer reported for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration at the right arm on 12Jan2021 15:15 at single dose for Covid-19 immunization in a hospital. Medical history included hyperthyroidism, allergies to medication, allergies to food. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021 07:30, the patient thought she was having a minor allergic reaction, she had some small hives on her thumb earlier and her skin was sensitive. The patient has not been tested for COVID-19 since the vaccination. The patient did not received treatment due to the events. The outcome of the events minor allergic reaction, small hives on her thumb, and skin was sensitive was recovering. The reporter considered the events non-serious which did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.
42 2021-01-20 numbness transient numbness in left arm resolved within 10 minutes of onset.
42 2021-01-20 pain in extremity, tremor 14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120.... Read more
14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120. I went home from work and became itchy to my neck and arms . At about 20 hours later I became short of breathe and pulse standing would go up to 140. I rested and continued taking Motrin and Tylenol as suggested . I ate minimally despite nausea . I messaged my Dr the next AM. By that time my glucose was settling down to normal and my Bp and pulse . The headache got worse and I had a pain in my axilla on the same arm I received the vaccine. I developed ?lymphadema? in that area which is sore to touch or move my arm. I reached out to infectious disease Dr at the hospital I work at and he suggested to continue Tylenol and Motrin and wait a week as this is due to vaccine. It is now Day 3 following vaccine and I am yet unable to work. My arm and axilla area is sore and I can?t lift my arm without pain, I have headaches and nausea as well.
42 2021-01-20 pain in extremity High fevers; chills; sweating; Extreme knee joint and calf muscle pain; Extreme knee joint and calf ... Read more
High fevers; chills; sweating; Extreme knee joint and calf muscle pain; Extreme knee joint and calf muscle pain; Extreme knee joint and calf muscle pain; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) on 09Jan2021 08:00b for Covid-19 immunisation, administered at hospital. Medical history included Crohn's disease, allergies to sulfa drugs. The patient had not experienced Covid-19 prior vaccination. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 19Dec2020 14:30 for Covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient experienced high fevers, chills, sweating and extreme knee joint and calf muscle pain on 09Jan2021 20:30. No treatment received. Post vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering. Information about Lot/Batch number is requested.
42 2021-01-20 pain in extremity Vaccine received on Jan 18-- Jan 19th- body aches, fever,fatigue jan 20th- body aches, fatigue jan ... Read more
Vaccine received on Jan 18-- Jan 19th- body aches, fever,fatigue jan 20th- body aches, fatigue jan 21st-rash on left hand/arm- left arm pain
42 2021-01-21 electric shock sensation, pain in extremity 12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client ... Read more
12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client improved that evening. 1/20/2021 Four hours after second vaccine dose - Body aches, intense headache over right eye, The evening of the same day - Heaviness to left arm, increased pain to left arm radiating to hands, tightness to the left arm with a feeling of "electricity" in the arm. The pain increased in intensity to the left arm during the night. Unable to sleep due to intense pain to the left arm and axilla. 1/21/2021 In the morning, client experienced abdominal pain and diarrhea once (loose stool). She noted swelling to the left axilla, intense pain, swelling below the left jawline. 1/22/2021 Early morning nausea without emesis, itching of the right forearm and nape of the neck, throbbing pain to left axilla with itching, throbbing to the left ear, which has not been sensitive to pain due to deafness.
42 2021-01-21 tenderness, pain in extremity Left axilla pain, painful area posterior left axilla, swollen firm lymph nodes to left lateral axill... Read more
Left axilla pain, painful area posterior left axilla, swollen firm lymph nodes to left lateral axilla/ breast, tenderness soreness to left brachial inner elbow up left bicep into axilla
42 2021-01-21 tremor Systemic: Chills-Medium, Systemic: Joint Pain-Medium, Systemic: Shakiness, weakness in the legs-Medi... Read more
Systemic: Chills-Medium, Systemic: Joint Pain-Medium, Systemic: Shakiness, weakness in the legs-Medium
42 2021-01-22 pain in extremity, tingling, discomfort At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg... Read more
At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg Advil max. At minute 45 after shot, I began to feel light tingling under my skin near the injection site, which slowly progressed to my elbow then my shoulder then my wrist, then to my neck and chin (all on left side) at which point I asked the HCP who gave the shot if I should take an antihistamine, she asked me if I was having trouble breathing and I said no, she recommended I take 500 mg of Benadryl 3x every 8 hrs. I took the dose about 75 min after my shot, by which time I felt tingling in my foot and pain in my wrist, slight feverishness. Fell asleep, woke up 4.5 hrs after the shot. The tingling sensation was gone. Only some drowsiness and pain in my arm. Applied ice pack to arm, took 250 mg Benadryl at 9.5 hrs after shot and woke up next morning with negligible symptoms, mild arm pain.
42 2021-01-23 muscle spasms Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, ... Read more
Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.
42 2021-01-23 tingling, bell's palsy, slurring Bells Pallsey event Left arm, face, tongue numbness and tingling, slurred speech, no left facial mo... Read more
Bells Pallsey event Left arm, face, tongue numbness and tingling, slurred speech, no left facial movement Last approximately 1hr 1/2 then full function returned
42 2021-01-24 feeling cold, pain in extremity, weakness Timeline reported by patient as follows. Monday: 1-4-2021 Cold feeling down my arm, within 30 mins ... Read more
Timeline reported by patient as follows. Monday: 1-4-2021 Cold feeling down my arm, within 30 mins felt nauseous- got something to eat since didn't eat before- felt better throughout the day until around 3 pm. That is when my arm was very sore and pain down my right leg. This pain increased throughout the evening and other joints were affected including hips shoulders sternum, knees and ankles- overall body aches. Difficulty sleeping due to pain. Low grade fever of 99.9. Tuesday: 1-5-2021 Very sore arm but went away by midafternoon. about 5:30pm started having stabbing stomach pains that came and went throughout the night. Heat applied to help a little bit. Low grade fever 99.6 Wednesday: 1-6-2021 Woke up with some stomach pain but not stabbing. Still had body aches and still not able to sleep through the night (this is uncommon for me- i sleep hard through the night)- Keft work early due to not feeling well. Temp 99.9 Thursday: 1-7-2021 Tired, body aches, still some stomach issues, not able to sleep through the night Friday:1-9-2021 Tired, stomach feels unsettled, body aches, up again throughout the night Saturday: 1/10/2021 Tired, no energy, stomach feel nauseous at times, body aches still present- tried to get some sleep during the day as well Sunday: 1-11-12021 Tired, still not restful sleep, bodys aches, chills, temp 99.9 Monday: 1-12-2021 Woke up in pain throughout body, some nausea, fever comes and go with high of 99.9 and low of 97.8. Chills with the higher temp., Emotional unable to stop crying for no reason (maybe because I'm not getting sleep?) Took 1/2 day of PTO due to not feeling well. headache Tuesday: 1-13-2021 Took PTO all day Pain throughout the body, nausea, exhausted, still not able to sleep all the way through the night- up multiple times for multiple hours, trying to get sleep thoughtout the day but still not getting a lot. Wedensday: 1-14-2021 Took PTO, continued body aches, stomach issues, no fever Thursday: 1-14-2021 Body aches, stomach pain and issues, no fever as of yet, headache,
42 2021-01-24 feeling cold Saturday 01/23/2021 staff started having headache and chill. Sunday, staff started sore throat. To... Read more
Saturday 01/23/2021 staff started having headache and chill. Sunday, staff started sore throat. Took Tylenol but it didn't help. On 01/19/2021 Covid test done and the result was negative. Scheduled 2nd vaccine on 01/28/2021.
42 2021-01-24 feeling hot Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, he... Read more
Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.
42 2021-01-24 feeling jittery About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, ... Read more
About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.
42 2021-01-24 flushing reports that on 1/21 she received 2nd dose of Covid vaccine. Went to work Friday 1/25--started havin... Read more
reports that on 1/21 she received 2nd dose of Covid vaccine. Went to work Friday 1/25--started having chills, body aches, HA. On Saturday,- fever and chills, body aches, HA. Reports on Sunday she felt slightly better, but still some s/s. Today 1/25: reports she feels flushed and HA still present.
42 2021-01-24 hot flush Felt miserable, collapsed, blacked out for unknown length of time, diarrhea, sweating, hot flashes.
42 2021-01-24 numbness Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; m... Read more
Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19.
42 2021-01-24 numbness Left side of face is numb, increases with nasal congestions, below cheek and above eye but vision is... Read more
Left side of face is numb, increases with nasal congestions, below cheek and above eye but vision is not affected at this time, no noticeable facial droop. So far cannot tell by looking at face. started out feeling like "tingly after seeing the dentist" then turned to numb and progressed to the eye. now eye is numb.
42 2021-01-24 migraine Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I... Read more
Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I had temperature of. 101.8. Achy, body/joints, headache. About 11pm I had a temp of 102.8. All the same symptoms, slightly heavy chest with breathing but not problematic. Very tired and no energy.The symptoms 36 hrs. Medication to help reduce fever did not work. After 36 hours I felt better except I still had no energy, and I had a migraine that lasted approximately 5 days ( lasted through Sunday January 10, 2021) I am a white female with red hair.
42 2021-01-24 pain in extremity, numbness, tingling, sciatica, facial paralysis left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left j... Read more
left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-24 pain in extremity No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with ... Read more
No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with hives, uticaria, and mild angioedema that has not yet subsided despite having received treatment. was told it could be a late reaction and that i should report it.
42 2021-01-24 pain in extremity Initially was just arm soreness and then 3 days later I woke up and noticed swollen glands on my col... Read more
Initially was just arm soreness and then 3 days later I woke up and noticed swollen glands on my collarbone and on my neck and on the side of my neck on the left side, they were tender and mobile. They got considerably smaller in a week but it took about a 2 weeks and one of them went away I still feel the others. Consulted with PCP who ordered labs. All normal results.
42 2021-01-24 pain in extremity 12 hours after receiving the first dose I started having chills. Shortly after that I begin to exper... Read more
12 hours after receiving the first dose I started having chills. Shortly after that I begin to experience nausea vomiting bodyaches dizziness headache and arm soreness. This lasted for approximately 24 hours. After that symptoms went away except for arm soreness which lasted for a few more days.
42 2021-01-24 pain in extremity Approximately 12 hours after receiving the second dose of Covid I begin having chills. Shortly after... Read more
Approximately 12 hours after receiving the second dose of Covid I begin having chills. Shortly after that I also experienced nausea bodyaches headache lack of appetite dizziness as well as a sore arm with redness at the injection site. My arm is red, warm to touch, firm and has gotten slightly larger since day 2. It is now day 4 and I still have this red welt on my arm that is tender to touch. The other symptoms resolved after 24 hours.
42 2021-01-24 pain in extremity Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to sho... Read more
Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to shoulder, red swelling at injection site and hot to the touch, fatigue, and minor body aches. Pain at injection site started first at around 4pm on the day of the 2nd dose(Th). I woke the next morning (Fri) with arm pain and a little tired. Later that day around 4pm the fatigue, chills and fever started. Fever hit 101.5F overnight and then the fever broke by the morning (Sat). I felt a little tired on Sat, but all that remained as pain, redness and the feeling of a knot at the injection site (improved from Fri). Today (Mon) the knot still remains and the pain is gone. Slight pink around injection site, but much better.
42 2021-01-24 tremor 12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injec... Read more
12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injection site, extreme fatigue, high fever (103), shaking, muscle/body aches, nausea
42 2021-01-24 tremor Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable c... Read more
Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if there is any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and unknown if the patient had been tested for COVID-19 since the vaccination. On Jan2021, the patient experienced faint, shaking, febrile for around 36 hours, rigors, and light-headed. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-01-25 weakness Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, h... Read more
Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, headaches, chest pain, tachycardia up to 201, bp up to 210/101 with no cardiac history
42 2021-01-25 bell's palsy Development of mild right sided Bell's Palsy 16 days after second Pfizer COVID vaccination
42 2021-01-25 cold sweat Woke up at 01:00 with severe body aches; was hard to walk or move; cold sweats; Chills; fever of 100... Read more
Woke up at 01:00 with severe body aches; was hard to walk or move; cold sweats; Chills; fever of 100.3 F; This is a spontaneous report from a contactable nurse reported for herself. A 42-years-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular on 14Jan2021 10:00 at single dose on left arm for covid-19 immunisation. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), clonazepam (KLONOPIN), quetiapine fumarate (SEROQUEL), aspirin [acetylsalicylic acid] (ASPIRIN). The patient received first dose of COVID 19 for covid-19 immunisation at 42-years-old, lot unknown=False, administration date=on 24Dec2020 09:00 AM, administrator route=Intramuscular, vaccine location=Left arm. The patient experienced woke up at 01:00 with severe body aches, was hard to walk or move, cold sweats, chills, fever of 100.3 f on 15Jan2021 13:00. Lab data included body temperature 100.3 f on 15Jan2021 13:00. The event outcome was recovering. No treatment was received for the adverse event. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
42 2021-01-25 feeling hot Felt hot
42 2021-01-26 weakness DEVELOPED FEVER UP TO 100.4, JOINT PAIN, DIARRHEA, WEAKNESS, AND FELT LIKE HAD A HORRIBLE FLU. TOOK ... Read more
DEVELOPED FEVER UP TO 100.4, JOINT PAIN, DIARRHEA, WEAKNESS, AND FELT LIKE HAD A HORRIBLE FLU. TOOK 5 DAYS TO RESOLVE. WAS PRESCRIBED AN INHALER BY PCP (UNSURE WHAT IT WAS)
42 2021-01-26 bell's palsy The patient presented with L side Bell's Palsy
42 2021-01-26 facial pain, tingling Herpes Zoster (Shingles)- tingling, rash, sharp shooting pains all on left side of face. Acyclovir 1... Read more
Herpes Zoster (Shingles)- tingling, rash, sharp shooting pains all on left side of face. Acyclovir 1 GM tablet TID
42 2021-01-26 numbness, migraine, tingling Within a few minutes right hand and forearm (shot arm) was numb then tingling and neck got hot. On ... Read more
Within a few minutes right hand and forearm (shot arm) was numb then tingling and neck got hot. On the drive home developed a headache. No fever. Day 2 migraine like headache most of the day and numb right hand when woke up, shot sight sore Day 3 better slight headache, shot site sore Day 4/5 woke both mornings by migraine like headache that went to neck (neck and shoulder pain) Day 6 okay so far
42 2021-01-26 numbness, migraine Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept fo... Read more
Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept for 16 hours
42 2021-01-26 numbness, pain in extremity, tingling While driving home after my 2nd vaccine and about 45 mins after my vaccine was administered my face ... Read more
While driving home after my 2nd vaccine and about 45 mins after my vaccine was administered my face began to feel numb and tingly. I immediately took Benadryl when I arrived home and had no further facial symptoms. However, approximately 23 hours post vaccination I developed a fever of 102 and chills that lasted approximately 6 hours. After the fever broke, I have had no further symptoms other than a sore arm and have not missed any work.
42 2021-01-26 migraine About 7 hours after I started to get migraine/sinus pain Dizzy Exhausted Arm pain at injection site ... Read more
About 7 hours after I started to get migraine/sinus pain Dizzy Exhausted Arm pain at injection site Fever and chills that rolled in and out The above symptoms lasted for three days. The extreme exhaustion lasted for 9 days. I was sleeping the whole night and taking 2-3 naps throughout the day for 2-3 hours.
42 2021-01-26 pain in extremity, weakness Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling very weak. Sti... Read more
Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling very weak. Still have headache not as severe and weakness a little less but still have all symptoms except chills.
42 2021-01-26 tingling, paralysis, speech disorder heart started to race; tingling sensation from her left arm that radiated to all over her body to th... Read more
heart started to race; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; heart rate jumped to 160; heart rate jumped to 160 and blood pressure went up; choking sensation on her neck; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date), dose number 2 via an unspecified route of administration on 12Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history was not reported. The patient did not have COVID prior vaccination. The patient previously took nitroglycerin and experienced drug allergy. Historical vaccine included BNT162B2 (lot number EL0140, dose number 1) for immunization on 22Dec2020 after which the patient experienced mild headache. Concomitant medications were not reported. There were no other vaccines received within 4 weeks. The patient had no adverse reaction other than mild headache after the first dose, so she was very relaxed and she felt comfortable getting the 2nd dose. However, after 10 minutes after the second dose, her heart started to race and she started to feel a tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed. Her heart rate jumped to 160 and her blood pressure went up. She couldn't even open her eyes nor speak a word. She was transported to the ER and was given steroids and anti-histamine. She refused to get an epinephrine shot at first, but she started to feel choking sensation on her neck so she asked for an epi shot. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events heart racing, tingling sensation, paralyzed, heart rate high, blood pressure increased and chocking sensation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-27 pain in extremity Fever, extremely sore arm (could barely move it), terrible headache, body aches.
42 2021-01-27 tingling After 10 days, still have fatigue and facial and scalp tingling (comes and goes). Pain in injection... Read more
After 10 days, still have fatigue and facial and scalp tingling (comes and goes). Pain in injection site reoccured overnight (night 10) and injection site is sore to the touch after 10 days. New feeling of some leg weakness today. First seven days included fatigue, chills, facial/scalp tingling, headache.
42 2021-01-28 feeling hot Severe vomiting lasting 10.5 hours, Fever 101.7, headache, chills, hot sweats. All all lasting bet... Read more
Severe vomiting lasting 10.5 hours, Fever 101.7, headache, chills, hot sweats. All all lasting between 12am-10:30am. After the vomiting subsided I was able to take Tylenol for the fever and all symptoms resolved.
42 2021-01-28 feeling of body temperature change Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 h... Read more
Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 headache, body ache, chest pain probably from coughing. Cough was deep and hard in the morning after waking through out the morning I would cough a couple more time by noon I'm not coughing but my chest is heavy.
42 2021-01-28 flushing Sudden onset of flushing of the chest and upper extremities, subjective throat tightness and tongue ... Read more
Sudden onset of flushing of the chest and upper extremities, subjective throat tightness and tongue swelling not evident on exam. Onset within 10 minutes of administration, provided 50 mg diphenhydramine, symptoms resolved within 1 hour completely. No wheezing, stridor, urticaria.
42 2021-01-29 numbness, flushing Elevated heart rate, dizziness, flushing, numbness in hands - twice, one and five hours after shot. ... Read more
Elevated heart rate, dizziness, flushing, numbness in hands - twice, one and five hours after shot. Passed by itself.
42 2021-01-29 pain in extremity Fever 100.8. Body aches. Headache. Fatigue. Nausea. Arm pain
42 2021-01-30 pain in extremity That evening I felt my arm painful, warm to touch and felt like a hard ball at the injection site wh... Read more
That evening I felt my arm painful, warm to touch and felt like a hard ball at the injection site while I was trying to sleep. The next day I looked and saw there was a red circle around the injection size about the size of a quarter, now it?s the size of a silver dollar still red, hot, hard, and painful.
42 2021-01-30 tremor The morning after vaccination, fever to 100.7, severe body aches from the waist down (especially low... Read more
The morning after vaccination, fever to 100.7, severe body aches from the waist down (especially lower back, buttocks and thighs) and severe fatigue. These symptoms lasted all day. For a 5 hour period lasting 18 to 23 hours following the vaccination, I also had severe chills. I laid under 8 layers of blankets and still could not feel warm and stop shaking (that was the most severe period of symptoms). The next day I awoke feeling normal, just tired form the day prior.
42 2021-01-31 numbness Left facial numbness
42 2021-01-31 pain in extremity Body aches, fever = 101.5, swelling in arm, soreness in arm
42 2021-02-01 weakness, pain in extremity Reported to me over the phone:The night of the vaccination the left arm became very painful and swol... Read more
Reported to me over the phone:The night of the vaccination the left arm became very painful and swollen. The next day the swelling continued into armpit, noticed chills from waist down and a decrease in ROM with weakness.
42 2021-02-01 weakness approximately 15 minutes after vaccine I felt a headache and dizziness. A few hours later I felt my... Read more
approximately 15 minutes after vaccine I felt a headache and dizziness. A few hours later I felt my heart racing, throat swelling, chills,weakness, tired, pain and swelling at injection site(right arm)
42 2021-02-01 burning sensation very tiny rashes on the back of her right hand; cannot see them but she can feel them since they are... Read more
very tiny rashes on the back of her right hand; cannot see them but she can feel them since they are drying , reports it is a burning sensation; This is a spontaneous report from a contactable consumer reporting for self. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 (Dose 1) as a single dose, right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 31Dec2020 in the morning, she had very tiny rashes on the back of her right hand, opposite side of her palm; she received the injection in the right arm. The very tiny rashes were there for 4 or 5 days and then slowly disappeared. Then the same rashes came back again on the same hand. She stated she "cannot see them but she can feel them since they are drying;" she reported it as a burning sensation and she wished she could put something cool on there. At the time of the report, the rashes and burning sensation were going away(recovering). She took a picture of it and she can send that in. She can get the second dose today or tomorrow and wanted to know if it was ok for her to get the second dose. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
42 2021-02-01 facial paralysis, facial pain facial paralysis; stress; facial pain; This is a spontaneous report from a contactable nurse. A 42-y... Read more
facial paralysis; stress; facial pain; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on an 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history includes ongoing facial paralysis (it was reported that the patient experienced facial paralysis caused by stress a couple of year ago and then again after the vaccination). Concomitant medications were not reported. The reporter felt worried about the patient (partner) that had facial paralysis and asked if they could administer the second dose of the vaccine of COVID-19 from Pfizer. The paralysis it was previous from the fist dose of the vaccine, a consequences of the stress, the partner had 42 years. The reporter considered that the event was non-serious. As of 15Jan2021, it was reported that the patient experienced facial paralysis caused by stress a couple of years ago and then again after the vaccination (24Dec2020). The patient also experienced pain in face on 24Dec2020. The patient underwent MRI on an unspecified date. Treatment was given for the events facial paralysis and pain in face (Anti-inflamatories). The outcome of the stress was unknown while not recovered for the other events. Information on the lot/batch number has been requested. Amendment: This follow-up report is being submitted to amend previously reported information: country of incidence was updated. Additional information received on 15Jan2021 from a contactable nurse includes: patient details (medical history and lab data), product details (therapy dates), reaction data (additional event: pain in face) and clinical course details.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of facial paralysis cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
42 2021-02-01 facial paralysis After first vaccine had LR rash after second vaccine had Bell?s palsy possible stroke
42 2021-02-01 flushing, feeling hot, tingling Pt noted she "tingling" in her left hand and her arms/face/neck became very hot and flushed approxi... Read more
Pt noted she "tingling" in her left hand and her arms/face/neck became very hot and flushed approximately 20 min after injection . This progressed into red itchy bumps she described as "hive - like" 3 hours after vaccine administration. She did not seek medical attention and denies any tongue swelling or difficulty breathing. She took benedryl that helped with the itching. She notes the "tingling" resolved in 6 hours, "flushing" improved in 9 hours and the hives resolved as of 02/01/2021 at 1130 AM.
42 2021-02-01 muscle spasms, flushing Heart palpitations, flushing, stomach upset with loose stools, headache, leg cramps, fatigue resolve... Read more
Heart palpitations, flushing, stomach upset with loose stools, headache, leg cramps, fatigue resolved within 12 hours
42 2021-02-01 pain in extremity Pain in left arm at 0200 woke me up and kept me awake. By noon on 1/12 I had fever that got to 101,... Read more
Pain in left arm at 0200 woke me up and kept me awake. By noon on 1/12 I had fever that got to 101, but responded to Tylenol. Ongoing chills. Fatigue, headache. All common side effects of vaccine per the education given at the time of the shot. I did go to work on 1/12 but ended up leaving around 1000. Fever, chills resolved around 0500 on 1/13. Fatigue, headache resolved around 1300 on 1/13. This is my 2nd baby, due June 7th 2021. All normal pregnancy so far. Recently had 20 week anatomical ultrasound that showed baby has slightly large tummy, doc will check for gestational diabetes at 28 weeks, did not express major concern.
42 2021-02-01 tingling tingling in hands
42 2021-02-02 bell's palsy, tingling slight tingling in fingertips of L hand, neck tension below jaw line, h/o Bells Palsy
42 2021-02-02 feeling hot, flushing Patient received her 2nd dose of the Pfizer Covid 19 vaccine at 8:30 am. At approximately 9:48 am sh... Read more
Patient received her 2nd dose of the Pfizer Covid 19 vaccine at 8:30 am. At approximately 9:48 am she returned appearing flushed and reporting that she felt very warm and was having trouble cooling down. She appeared 'blotchy' on her upper chest region, but no rash or hives anywhere else on her body. We had her lay down and checked a blood pressure, with a result of 132/70. Cold compresses were applied to the back of the neck and the forehead to help cool her down. Later rotated from the back of the neck to the upper chest/neck region. Patient was observed for 15-20 minutes by the administering pharmacist and nursing staff. During that time she appeared less flushed and redness on the chest region improved. She reported feeling improved and returned to work, with regular checks made by nursing staff to ensure symptoms did not return.
42 2021-02-02 muscle spasms 1/29/21 Friday night: Muscle in upper arm knotted up so bad it pinched the nerve and my arm was use... Read more
1/29/21 Friday night: Muscle in upper arm knotted up so bad it pinched the nerve and my arm was useless. I had muscle weakness and joint pain down to my wrist. I had to do old physical therapy exercises, ice pack on upper arm, and took tylenol (really wanted to take advil). Saturday evening: I discovered my lymph gland was swollen and very sore under my left arm. Took a hot shower and it helped. As long as I don't wear a regular bra it's ok. Sore to touch or if I moved my arm a lot. Tylenol (again with the advil)and heating pad. Still sore today. Creeps me out. I also, slept all day Saturday. Took a long nap Sunday. Went to the clinic on Monday, back to another clinic on Tuesday-Tuesday was when I had the extreme exhaustion. I napped for 3 hours in the afternoon and was so tired and woozy when I woke up. I had brain fog. Couldn't concentrate or care about much for awhile. Today, I slept in, and feel fineat the moment. Waiting to see if I have that nap exhaustion thing. I plan to walk some and go pick up some Vitamin C and Zinc supplements today.
42 2021-02-02 tingling She took the first Pzfier vaccine December 16 and 6 days later, she had complete hearing loss in lef... Read more
She took the first Pzfier vaccine December 16 and 6 days later, she had complete hearing loss in left ear. She first noticed the loss of hearing occurred after a run. The pt had a piercing headache and the next morning she could not hear out of left ear. She recalls having a slight headache and tingling on the left side of her face, just after the vaccine. MRI of the brain normal. Prednisone taper, starting at 60 mg and received intratympanic steroid injections. The steroid did not help her regain her hearing. She was then seen by doctor and underwent a dozen hyperbaric O2 therapy. Pt is beginning to get her hearing back in left ear.
42 2021-02-03 involuntary muscle movements (This RN was not direct observer of initial incident. Initial events as reported by initial respondi... Read more
(This RN was not direct observer of initial incident. Initial events as reported by initial responding RNs). Pt had just received Pfizer vaccination and was seated in observation area. Was observed to be "not looking well" and approached by staff. Pt began to hyperventilate, exhibit repetitive jerking motions to upper body/"pseudo seizure-like activity", and reported feeling nauseated. Began to slide out of chair, x2 RNs assisted pt to floor. Pt then placed in wheelchair and taken to Triage tent A. Pt remained alert and oriented throughout duration of event. VS @0915- BP 128/77 HR 131 Sats 100% on RA. 0.3mg IM epinephrine given at 0919. VS @ 0920 HR 108 0938 O2 sats 87% on RA, applied 0.5L O2 via nonrebreather mask. Sats back up to 100% @ 0939. Pt remains alert, intermittently exhibits periods of jerking actions and hyperventilation between periods of calm. With staff assist, called husband who was en route. VS @ 0940- HR 101, Sats 100% on 0.5L via nonrebreather. 50mg IM Benadryl given at 0940. VS @ 0950 HR 109 sats 100% on RA. Husband, to bedside. Pt remains alert. 1007 EMS arrives for transport to Emergency Department
42 2021-02-03 hot flush I have had hot flashes two days after my vaccination.; I have them every night since and have not be... Read more
I have had hot flashes two days after my vaccination.; I have them every night since and have not been sleeping well due to them; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 05Jan2021 15:30 at single dose for covid-19 immunisation. The patient's medical history included Known allergies: PCN, latex, eggs. The patient was not pregnant at time of vaccination. There were no concomitant medications. On 07Jan2021 22:00, the patient has had hot flashes two days after vaccination. The patient has never had hot flashes before. The patient have them every night since and have not been sleeping well due to them. The patient did not received treatment for the events. The outcome of the events was not recovered.
42 2021-02-03 migraine Headache- migrane, chills, muscle soreness, lethargy/ tiredness, lack of appetite/ nausea
42 2021-02-03 migraine 42 yo female presented at urgent care 3 days after receiving covid 19 vaccine with migraines. Patien... Read more
42 yo female presented at urgent care 3 days after receiving covid 19 vaccine with migraines. Patient with past medical history of migraine in the past. Per provider assessing patient believes her symptom of headache was consistent with past migraine. Patient states she received vaccine 1/14/21 and had dizziness and chills for a day that resolved. Then yesterday she began to have a migraine which was similar to her migraine presentation in the past. Patient given ketorolac x1 and Zofran x1. Patient prescribed Zofran . Pt instructed to continue home Imitrex and follow-up with PCP.
42 2021-02-03 pain in extremity Dizziness, sore arm
42 2021-02-04 pain in extremity, burning sensation On Saturday, her arm was sore, having chills, fatigued as well. The symptoms kind of went away. On... Read more
On Saturday, her arm was sore, having chills, fatigued as well. The symptoms kind of went away. On Thursday night, 1/28/21 had burning sensation on her feet, like fire on her feet. Went to bed, the feeling went over her entire body. The sensation continued on her hands and her feet. She went to the ER on Saturday morning, early in the AM on 1/30/21, informed her hemoglobin was a little low. Said that it could be neuro, saw her doctor and informed that she had received the vaccination and he prescribed Gabapentin for the neuropathy. He did blood work and going to check what would trigger the neuropathy pain.
42 2021-02-04 pain in extremity Pain in arm Pain in shoulders and neck Very bad nausea Vomited once Fatigue
42 2021-02-04 tingling Tingling in left hand, specifically thumb and index finger. Not fully numb. Hasn't gotten better o... Read more
Tingling in left hand, specifically thumb and index finger. Not fully numb. Hasn't gotten better or worse since 10 min after injection. Time is now 8:35 pm
42 2021-02-05 tingling, numbness Patient self pre-medicated with diphenhydramine at 0730 due to reaction from Pfizer 1st COVID vaccin... Read more
Patient self pre-medicated with diphenhydramine at 0730 due to reaction from Pfizer 1st COVID vaccination. Today 2/5/2021, 2nd vaccination approximately 0800. Started to feel chills and numbness/tingling in left arm which was vaccination side. Then developed numbness/tingling in both legs below the knees. Placed on pulse oximeter and vitals monitored. Vital signs normal although initially blood pressure elevated but came back down. ~0830 Patient placed on gurney, covered with warm blankets and given oral medications: diphenhydramine 25mg, famotadine 20mg, acetaminophen 500mg. At 0930 patient taken to ED as symptoms were not resolving. Patient had difficulty transferring from gurney to wheelchair for transfer due to leg numbness.
42 2021-02-07 weakness 12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. ... Read more
12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. Itching and erythema. Ears began to swell and became hot and red. Face and neck uncomfortable. Took Benadryl when went to bed at midnight. 1-1-2021 In evening began severe itching and erythema form head to breasts including arms which lasted three hours. Right eat internal soreness. 1-2-2020 Fifteen minutes after eating began sudden stomach crapms and then larger amounts of diarrhea and vomiting. Later had another episode of vomiting and diarrhea. Felt weak with labored breathing, chills, Fever 100.2, another bout of diarrhea and vomiting. Productive cought that started in the evening with clear mucous.
42 2021-02-07 feeling hot blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; Thi... Read more
blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient). The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization. Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021. It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed. Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
42 2021-02-07 muscle spasms Patient returned at 9:36am after receiving first dose at 8:41 complaining of nausea and dizziness. ... Read more
Patient returned at 9:36am after receiving first dose at 8:41 complaining of nausea and dizziness. Vital signs taken and assessment determined Benadryl needed. Patient was given 0.4mL =(20mg) . Patients vitals checked every 5 minutes. At 10:16 patient felt better and reposted symptoms better and no dizzy spells. Pt released at 10:38. Patient called for update on 2/5/21. Patient reported feeling better this day but reports that nausea returned with cramping and lasted until 2:30 pm day of shot. Dizziness and confusion lasted until 9:00pm day of injection, disoriented until 6pm day of injection and diarrhea that lasted until 4pm day of injection. Per medical director, Dr, patient should not get second dose of Pfizer vaccine.
42 2021-02-07 pain in extremity at first I had the expected reaction and feeling of being "hungover" on night after vaccine, 7pm on ... Read more
at first I had the expected reaction and feeling of being "hungover" on night after vaccine, 7pm on 1/29/2021. I felt better overall in 24 hrs, but I've continued to have mild arm pain at injection site. Now, over a week and a half later, on 1/8/2021, I have mild itching at injection site and moderate arm pain. V-safe check-in site I was using has stopped actively sending my daily checkins after a week, switching to weekly check-ins instead.
42 2021-02-08 burning sensation Red, itchy face with mild burning feeling, swollen throat with itch, and tingling in tongue.
42 2021-02-08 pain in extremity Within 15 minutes I felt really lightheaded, which went away after about 1/2 hr. That night about 9p... Read more
Within 15 minutes I felt really lightheaded, which went away after about 1/2 hr. That night about 9pm my R arm was aching SO bad, like I've never felt. Also I got a horrible headache and lower backache, could not sleep. Felt horrible till about noon the next day started to feel better slowly.
42 2021-02-08 unresponsive to stimuli, inability to speak anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous... Read more
anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-02-09 weakness I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minute... Read more
I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness/ same sensation in my arms, in arm that I got shot in and it came with hand weakness; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; Lethargy; Very tired; My heart kind of feel like it is pounding out from the chest like off and on throughout the day; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided. Patient got the vaccine on 17Jan2021 and she had been really brain fogged and on Tuesday and Wednesday she had a weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety and then Friday evening, patient had the same sensation in her arms, in arm that she got shot in and it lasted for about ten minutes and it came with hand weakness and then she had no muscle pain necessarily but lethargy, very tired and her heart kind of feel like it was pounding out from the chest like off and on throughout the day, events occurred on unknown date in Jan2021. Patient called the doctor and he said to wait but it is kind of there now, so she had an appointment on Wednesday. Outcome of the events was unknown. Information on the lot/batch number has been requested.
42 2021-02-09 muscle spasms Headache; muscle cramps; rash; This is a spontaneous report from a contactable other hcp (patient). ... Read more
Headache; muscle cramps; rash; This is a spontaneous report from a contactable other hcp (patient). This 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot # unknown), via an unspecified route of administration at single dose in the left arm on 13Jan2021 for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), venlafaxine hydrochloride (EFFEXOR). The patient previously took Keflex [cefalexin] and experienced drug allergy. On 13Jan2021, the patient experienced headache, muscle cramps, rash, all with outcome of recovering. No treatment required. The vaccine was administered at Hospital Facility. The patient had not been tested for COVID-19 post the vaccination. The patient was not pregnant at the time of vaccination. Information on the lot/batch number has been requested.
42 2021-02-10 flushing 5 minutes after receiving vaccine became very dizzy, and flushed with fast heart rate , dropped to ... Read more
5 minutes after receiving vaccine became very dizzy, and flushed with fast heart rate , dropped to the floor near syncope. Laid down and took off mask for air. Was offered water and Benadryl. Drank some water then felt better.. Refused the Benadryl. 10 minutes after someone noticed a possible rash on my forehead. Went ahead and took some Benadryl. Later that night had same feelings.. fast heart rate and dizziness. The next day development flu like symptoms with fever up to 102.9. Took a half Tylenol. The next day just felt achy . The day after that had diarrhea.
42 2021-02-10 numbness c/o numbness left side of body; dissipated until it was just the left side of her face 2 days later.... Read more
c/o numbness left side of body; dissipated until it was just the left side of her face 2 days later. H/O Bell's Palsy; team member advised to f/u with her PCP; unk. if she did seek medical treatment. She also reported HA, fatigue, fever, chills.
42 2021-02-10 migraine Employee states she developed a migraine the evening after receiving her 2nd COVID vaccine. She to... Read more
Employee states she developed a migraine the evening after receiving her 2nd COVID vaccine. She took medication which help dull the headache. She woke up the morning of 2/11/21 with hives on her face. She states her face was red and her eyelids swollen. The left eye lid more than the right. Employee took benedryl which helped, but her left eyelid remains red and swollen. Advised employee to contact her PCP.
42 2021-02-10 tingling, burning sensation TINGLING, DIZZINESS, BURNING IN HAND, SMOTHERING IN CHEST BUT NO BREATHING ISSUES, WHEN STANDING HAD... Read more
TINGLING, DIZZINESS, BURNING IN HAND, SMOTHERING IN CHEST BUT NO BREATHING ISSUES, WHEN STANDING HAD SOME TRANSIANT CHEST TIGHTING RX 25MG BYNADRYL, 16OZ WATER
42 2021-02-10 tingling, electric shock sensation About 10 min post vaccination start feeling tingling in your hands and fingers. Consulted with MD on... Read more
About 10 min post vaccination start feeling tingling in your hands and fingers. Consulted with MD on site that had stated others had complained about same reaction and was told to just observe. At night, I started itching really bad around 10:30PM and then I noticed a rash all over my body, both legs, specifically the right was worse. I also had patches on my arms and shoulders, also my chest and abdominal area. The rash was really read and bumpy. (I took pictures of the progression of the rash if interested). I took Benadryl and it barely helped me. Consulted with Employee Health who told me to consult with her PCP for advice. He prescribed Prednisone for a week and did some labs. And to do a FU in a week. The itching was unbearable. I even have like an electrical shock feeling in my skin since I started with this rash. I still feel it from time to time. On my FU with Dr. he noticed the rash was worse so he made me stop the Prednisone and wanted to do a biopsy from the tissue in my legs. Since I had the Prednisone in my system, I couldn't do it immediately, but was able to do it on 01/22/2021. Got my results the day before yesterday. It showed that I have what is called a Spongiopic dermatitis. Dr called me and prescribed me bleach baths 3 times a week and another antibiotic. I am scheduled for my second dose on 02/16/2021.
42 2021-02-11 numbness, tingling Facial numbness and tingling that lasted for several hours. Also right hand numbness. I would like t... Read more
Facial numbness and tingling that lasted for several hours. Also right hand numbness. I would like to know if this is an allergic reaction and precludes the second dose?
42 2021-02-11 pain in extremity I started having increased pain under my left arm that increased to some chest discomfort, body ache... Read more
I started having increased pain under my left arm that increased to some chest discomfort, body aches, low-grade fever. When I woke up the morning of the 8th I had a swollen lymph node the size of a baseball under my left arm.
42 2021-02-12 numbness, pain in extremity Received vaccine at 1:48pm at PODsite. Initially, no reaction. By following morning, 2/11, woke with... Read more
Received vaccine at 1:48pm at PODsite. Initially, no reaction. By following morning, 2/11, woke with sore arm, slightly stiff neck, and heart palpitations that persisted throughout the day. Had trouble sleeping as palpitations continued throughout the night and varied in degree from a flutter to a thump. No chest pain, no chest pressure and no breathing issues. By morning of 2/12, symptoms were still present and numbness in both arms from elbow to finger tips occurred. Called my healthcare nurse's line for advice to determine if I should see my doctor or go to ER. I was advised to visit the ER. Arrived at ER at approximately 12:56pm where I was immediately admitted and assigned to doctor. After my first 30-60 mins of observation, I was informed that my heart rate and blood pressure were high. I informed doctor that I have never had high blood pressure, so that is unusual. Was discharged around 4pm and instructed to submit an adverse reaction report and to see my general practitioner in 2 days. I was informed the following: no evidence of an acute cardiopulmonary process. Heart size and contours are normal.
42 2021-02-13 migraine "Pt stated got Pfizer COVID-19 vaccine 1st dose. Last night HA, fatigue this AM migraine. Pt states ... Read more
"Pt stated got Pfizer COVID-19 vaccine 1st dose. Last night HA, fatigue this AM migraine. Pt states has 75 mg and 100 mg imitrex, has not taken imitrex"
42 2021-02-14 numbness, tingling Tingling/numbness throughout my left hand and some in forearm / Sudden onset of pretty severe diffus... Read more
Tingling/numbness throughout my left hand and some in forearm / Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; tingling/numbness throughout her left hand and some in forearm; tingling/numbness throughout her left hand and some in forearm; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Intermittent discomfort in forearm; winging of her left scapula; weakness of serrates anterior; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration in the right arm on 06Jan2021 07:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, raynaud's symptom, orthopedic surgeries. Concomitant medication included levothyroxine (unknown manufacturer). The patient previously took aspirin and gabapentin and experienced drug hypersensitivity. On 18Jan2021 13:00 the patient experienced tingling/numbness throughout her left hand and some in forearm, sudden onset of pretty severe diffuse pain 1.5-2 days later (Jan2021) in left shoulder, axilla, anterior chest wall, persistent and consistent significant pain that does not change with position, ROM, or much with palpation, intermittent discomfort in forearm, evolving into the progressive weakness phase with significant winging of her left scapula and weakness of serrates anterior. Events resulted in emergency room visit and physician office visit. The events were evaluated by an MD who has given the patient a tentative diagnosis of Neuralgic Amyotrophy. Seeing a neurologist on 02Jan2021. The outcome of the events was not recovered. The patient received mediation to manage pain. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
42 2021-02-14 pain in extremity woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all... Read more
woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; Mallampati score 4, not my baseline; Moderate fatigue rest of the day; Sore arm was experienced within 5 hours of administration; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at Left arm on 29Dec2020 17:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension (HTN), ablation corrected Wolff-Parkinson-White syndrome, pre-eclampsia. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), ibuprofen, naproxen sodium (ALEVE) and Women's multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took trolamine polypeptide oleate-condensate (CERUMENEX) and experienced allergy. The patient's sore arm was experienced within 5 hours of administration on 29Dec2020. Next morning 15 hours post, woke with swollen tongue, throat, and all mucosal linings. Mallampati score 4, not her baseline. Moderate fatigue rest of the day. Finally took Benadryl at 23-hours post vaccine, had to repeat Benadryl every 8 hours for 2 more days and monitor symptoms, events onset date was 30Dec2020 08:30. Adverse events result in: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of Swollen tongue, Throat edema, Oral mucosa swollen, and Physical examination abnormal cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-02-14 tenderness, weakness, pain in extremity, feeling cold Approx 10- 12 hours after the shot was given, patient was home and in severe pain deep joint and mus... Read more
Approx 10- 12 hours after the shot was given, patient was home and in severe pain deep joint and muscle pain, shivering, sweating, freezing, low grade fever, severely weak, collapsed to the floor the first morning after receiving the 2nd dose shot bc she couldn?t make it back upstairs on her own. Injection site was red and swollen with a defined border. Severe pain at injection site as well. All symptoms listed to this point lasted for 48 hrs. After that severe joint and muscle pain diminished and pain medication (ibuprofen 800mg) was no longer being taken. However, severe arm soreness, tenderness, redness, swelling and itchiness remained/started on day 3. Itchiness spread from only the arm to entire body by day four. Patient went to hospital on day 4 but did not get admitted because they wanted to care for her in the Covid unit without knowing if she had Covid or not. Patient administered self-care by taking Benadryl continuously for approximately 48 hours starting on day 4. She stayed home after attempting to get help from redlands community hospital ER because she didn?t feel comfortable being told she could only get care if she went into the covid unit without a covid test being offered or done to her first. Patient was bedridden and severely sick from February 1 through February 7 2021. Feb 11 2021 patient took a covid test to rule out covid as the reason she felt so bad. Test result for covid was negative.
42 2021-02-14 tenderness, weakness developed diffuse tender adenopathy, weakness and fevers. Admitted with severe neutropenia - ANC 0.
42 2021-02-15 nerve pain Lungs closing up, trouble breathing, pulse ox drop. Like an asthma attack but inhaler did not help.... Read more
Lungs closing up, trouble breathing, pulse ox drop. Like an asthma attack but inhaler did not help. It lasted about 4 hours. Shooting nerve pain through my body for several days. Overall sluggish for two days, body aches, exhaustion.
42 2021-02-15 seizure Patients experienced a mild seizure during observation period following vaccine. EMS was called and ... Read more
Patients experienced a mild seizure during observation period following vaccine. EMS was called and patient came to immediately after. RN took vitals on Patient while we waited for EMS to arrive. Patient has history of seizure disorder but had no issue with 1st dose. EMS evaluated at scene and Patient returned to residence facility.
42 2021-02-15 tremor, weakness I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vom... Read more
I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vomited forcefully several times. My neck and upper back became stiff and painful. Then came chills, shaking, and more nausea. My throat felt like there was a lump in it that was closing me off. I felt very weak and easily fatigued. I started to have visual issues, confusion, and was unable to focus. Neck pain continued to be severe. The next morning I woke feeling good, but within 2 hour again I went downhill. Symptoms are only about half as bad as the day before. Very very tired.
42 2021-02-16 migraine, feeling cold, night sweats Woke up at 3:30am with severe chills and night sweats, could not get warm. Fever (101.7) started at ... Read more
Woke up at 3:30am with severe chills and night sweats, could not get warm. Fever (101.7) started at 8am 1/10 . took Acetaminophen 1000mg for fever, headache, body aches, and weakness in extremities , increased fluids. Noticed a swollen sub clavicular lymph node on the left side That grew to the size of an almond. Migraine started at 11am same day. Took PRN Maxalt for Migraine and slept the rest of the day. Next day (1/11) slight headache that waxed and waned the rest of the day. Fever of 100.1 by 2:30 that same afternoon. Took Acetaminophen and fever resolved by the next day. Was seen for lymph node a week later by PCP and sent for an ultrasound. On 2/5 was scheduled for biopsy but on Ultrasound the lymph node had decreased in size from 2cm to 1.5cm on its own. Decided to hold off. Lymph node is now normal in size
42 2021-02-16 muscle spasms Within 15 min of shot, started with mild cramping, within 45 min had stronger cramping and nausea. C... Read more
Within 15 min of shot, started with mild cramping, within 45 min had stronger cramping and nausea. Cramping and nausea resolved within 3-4 hours. Fatigue for 2 day.
42 2021-02-17 weakness Itching and feeling off over a week post second dose. The following day I was extremely tired and we... Read more
Itching and feeling off over a week post second dose. The following day I was extremely tired and weak. By that evening, day 9 or 10, I began vomiting followed by horrible diarrhea that lasted about 12 hours. I never thought it was related to the vaccine until I heard from others that had the same symptoms days after their vaccine.
42 2021-02-17 discomfort I was in observation for about 45 min due to the symptoms I had with the first dose. About 10 min af... Read more
I was in observation for about 45 min due to the symptoms I had with the first dose. About 10 min after vaccination, I felt itching on my face, and it progressed to my back and hands. I also started coughing, no rash. In the evening, at home I started feeling shortness of breath and started using my albuterol inhaler and symbicort. I had a feeling like someone was sitting on my back, squeezing my left side, my left lung. I also experienced chest pain. I had to use symbicort and albuterol for about 5 days and the symptoms persisted for at least 3 days, itching, cough, chest pains. The symptoms went away and they returned 3 days ago. Now I am once again starting to experience cough and shortness of breath.
42 2021-02-17 feeling cold, feeling hot Hot, sweating. Ice cold freezing, body aches, slight headache. For about 12 hours
42 2021-02-17 numbness, tingling Patient complained of numbness and tingling on the Left arm. After a few minutes, patient reported ... Read more
Patient complained of numbness and tingling on the Left arm. After a few minutes, patient reported that symptom subsided, but remained constantly on the left hand. Patient was able to move extremity without pain. Patient reported that the symptom was experienced during the first dose, but only lasted for seconds.
42 2021-02-17 pain in extremity, discomfort smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had ... Read more
smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.
42 2021-02-17 pain in extremity Since Sunday 2/14 , pain that comes and goes in both legs. Mostly thighs. Weakness in thighs. Pain f... Read more
Since Sunday 2/14 , pain that comes and goes in both legs. Mostly thighs. Weakness in thighs. Pain feels mostly like tight muscle, but also had nerve like pain in upper outer right thigh for about 1.5 days. Not sure if related to the vaccine. Felt fine from 2/2-2/14.
42 2021-02-17 tension headache Chest and head tightness pale. EMS evaluated P90. O298% Lungs clear. Discharged home
42 2021-02-18 feeling cold, cold extremities Notice that my feet have been very cold. Describing as ?freezing? . Aching joints and knees
42 2021-02-18 flushing I got the shot at noon on Friday, February 12th. Felt pretty well with arm pain at injection site a... Read more
I got the shot at noon on Friday, February 12th. Felt pretty well with arm pain at injection site and flush face the rest of the date. On Saturday, the 13th, I was fatigued, extreme arm pain at injection site, flush face, and cold all day. Sunday, the 14th, much the same as Saturday until evening when extreme dizziness and diarrhea set in. Woke up in the night with extreme dizziness and nausea. All day Monday, 2/15, I had lethargy, lightheadedness, dizziness, flush face, body aches and chills. Tuesday, 2/16, same exact symptoms as Monday. Wednesday, 2/17 was still mild body aches and flush face. Thursday, lesser body aches but still flush face. Today, 2/19, I still have flush face and fatigue.
42 2021-02-18 numbness, cold sweat, tingling Clammy hands/feet early 5am on 2/13/21, went to ER 2/13/21 due to numbness on R side of face with... Read more
Clammy hands/feet early 5am on 2/13/21, went to ER 2/13/21 due to numbness on R side of face with tingling on R side of head and tightness of neck. 2/14 thrush in mouth 2/15 - achiness L arm 2/16- pain swollen lymph r side, clammy hands persist with foul smell Ongoing tingling in my Whole Back, Fluctuating BP , tachycardia
42 2021-02-18 tingling, pain in extremity Immediately following the vaccination, I had some site pain. I felt tired that evening and went to b... Read more
Immediately following the vaccination, I had some site pain. I felt tired that evening and went to bed early, sleeping well (Wednesday night). Approximately 20 hours after receiving my 2nd vaccine (10am Thursday), I developed a low fever (99`), extreme lethargy, chills, and overall body aches. These symptoms lasted approximately 13 hours. When my fever broke (approximately midnight Thursday), the body aches and chills went away as well. The next day (Friday), I woke up to significant arm pain, severe headache, tingles in my arm, swollen lymph nodes in my arm pit and neck, as well as a rash on my upper arm around the injection site. These symptoms persisted until Sunday. The rash and swollen lymph nodes disappeared Sunday night/Monday morning. Since Monday, however, the headaches, arm pain, and some tingles in my arm have persisted all week. Motrin curbs the pain of the headaches and arm pain, but as it wears off the pain resurfaces.
42 2021-02-18 paralysis could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ... Read more
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
42 2021-02-19 numbness, pain in extremity, tingling Soar arm the day of vaccine and 2 days after. Mild dizziness every day after receiving the vaccine.... Read more
Soar arm the day of vaccine and 2 days after. Mild dizziness every day after receiving the vaccine. The symptoms are not constant but I do feel dizzy on and off through out the day. Tingling and numbing sensation on the cheeks of my face after the vaccine, almost immediately. Then every day after that, but not constantly, more like once a day I feel the numbing sensation.
42 2021-02-21 pain in extremity, migraine, tenderness Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after i... Read more
Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after injection, headache and some fatigue-took Ibuprofen 36 hours after injection, migraine, arm pain, fatigue, nausea-took flexiril, Zofran, and Ibuprofen 48 hours after injection, fever of 101, armpit pain, arm pain, fatigue-took Ibuprofen 72 hours after injection arm swollen in 3"x5" oval, bright red, hot to touch, armpit very tender, mild headache-took Ibuprofen
42 2021-02-21 tingling Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February... Read more
Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February 5, 2021 at 2:03 PM. She received this here at facility campus vaccine clinic. She felt a strange tingling sensation immediately upon receiving the injection that extended from the injection site across her upper back but otherwise tolerated the injection well. Because of her history of food allergy she was advised to remain at the vaccination clinic for 30 minutes. During that 30-minute wait period she felt generally well however began to develop pruritus at her back in the legs. She did not mention this to the staff at the vaccine clinic and did not look at her skin. The pruritus was not too bothersome and she left the vaccine area after 30 minutes and walked down to our clinic to return to work. Her pruritus intensified very quickly upon returning to her desk and within a few minutes of after her return she went into the bathroom to look at her back and had patches of red, raised, urticarial lesions across her back. She began to feel itchy all over her body. She remained at work and did not take any medication or seek any medical help. She did not look at her legs. The pruritus intensified and when she looked at her skin of her legs approximately 1 or 2 hours later she had developed urticaria essentially head to toe. She had large confluent patches of urticaria at bilateral thighs, urticaria at her face, trunk, arms, legs.   At this point she felt otherwise well. She went home and took 10 mg of Claritin and applied a topical Benadryl cream to her skin. This was not helpful. She had severe pruritus of her eyes and eyelids. She took 50 mg of oral Benadryl which also was not particularly helpful. Sometime in the middle of the night that night she developed chills, felt feverish, and developed intense muscle and joint aches. She took an unknown dose of ibuprofen with minimal improvement in muscle and joint pain. She did have improvement in fever. Following day was Saturday, she spent the whole day in bed in extreme pain. She describes the pain at her wrists as feeling as though "somebody was breaking my bones" with any movement of her wrists. She had pain even laying flat in her bed and had severe pain at all of her joints with movement. She tried taking a flexeril with no improvement. She recalls a T-max of 102 sometime on Saturday or Sunday. At that time she had been taking ibuprofen around-the-clock. She also took 10 mg of Claritin approximately every 4 hours. Each night she also took 50 mg of Benadryl. She continued to experience urticarial skin rash and intense pruritus of the skin. The urticaria waxed and waned during this time. She also developed a fever blister at her lower lip. She spent most of Sunday in bed also. She was feeling a bit better by Monday however still had intense pruritus. Skin rash was much improved at most of her body however she still had mild urticaria at her face. She did not have a fever on Monday but was continuing to take ibuprofen around-the-clock. She discontinued ibuprofen yesterday and has not had fevers or chills since Sunday. At this point her urticaria has essentially resolved. She continues taking claritin 10mg BID to 3 times a day and also 50mg bendaryl at bedtime.   She did not experience any bruising related to this rash however did have excoriation from scratching particularly at her face.   Throughout the course of these days she did not have any episodes of angioedema of the lips, tongue. She denies difficulty breathing, cough, wheezing, shortness of breath, throat tightening, nausea, vomiting, diarrhea, dizziness, lightheadedness, syncope.   She has a history of oral allergy syndrome with peanut. Promethazine has caused diplopia, weakness. Simvastatin caused muscle weakness. She has never had any issues with vaccines. She has been getting a flu shot yearly with no difficulty. Her most recent vaccine was October 8, 2020, quadrivalent influenza vaccine.   No known history of allergy to polyethylene glycol.   No history of chronic urticaria. She takes NSAIDs frequently without any difficulty. She has not taken any NSAIDs prior to receiving this injection or developing this urticaria. She had however taken 10 mg of Claritin prior to receiving this injection.   She has no history of anaphylaxis. She has undergone surgery under general anesthesia on more than one occasion without issue. No history of reaction to stinging insect venom. She receives immunotherapy for inhaled environmental allergens here in our office and has done well with this.   She denies any recent medication changes or new over-the-counter medications.   She has not previously been diagnosed with COVID-19.
42 2021-02-22 weakness Site: Pain at Injection Site-Medium, Systemic: Weakness, Error: Wrong Dose of Vaccine - Too High
42 2021-02-23 numbness 30 minutes post-injection, patient reported numbness in her feet similar to when she has PEG before.... Read more
30 minutes post-injection, patient reported numbness in her feet similar to when she has PEG before. Pt. remained another 15 minutes and was advised to go to the ER and transported there, but wanted to go home instead and left without being seen. She said she would see her doctor if she started to feel bad. She was called 2/1/21 and reported feeling great and denied any needs.
42 2021-02-23 pain in extremity 02/13/2021: sore left arm, extreme fatigue started in afternoon 02/14/2021 - 02/15/2021: muscular pa... Read more
02/13/2021: sore left arm, extreme fatigue started in afternoon 02/14/2021 - 02/15/2021: muscular pain, headache, exhaustion, slight nausea, joint pain 02/16/2021 - 02/17/2021: extreme fatigue, joint pain 02/18/2021 - 02/24/2021: fatigue, joint pain (7 on a scale of 1-10)
42 2021-02-23 tingling per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that... Read more
per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body
42 2021-02-23 tremor, flushing anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue... Read more
anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-02-24 weakness tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appet... Read more
tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-02-24 hot flush, tingling, muscle spasms Right arm and hand felt tingling right away then neck got hot and a headache started within 5 minute... Read more
Right arm and hand felt tingling right away then neck got hot and a headache started within 5 minutes. Monday 2/12 muscle fatigue and joint pain until current date 2/25 (I work out every day. After the first dose I was okay (after headaches subsided) but this time my muscles while working out have been very fatigued and spasm and cramp during workouts. Joints have been sore too)
42 2021-02-24 numbness, tingling tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by ti... Read more
tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; Brief period of pain in my right bicep; Headaches off and on; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN0201, expiry date: unknown), via an unspecified route of administration on the left arm, on 10Feb2021 09:30, at single dose, for covid-19 immunisation, at the hospital. Medical history included anxiety and bipolar II disorder (reported as bipolar2). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), quetiapine fumarate (SEROQUEL) and "OTC vit" (as reported). The patient previously took lamotrigine and experienced allergies (known allergies: Lamotrigine). The patient did not receive any other vaccines prior to the COVID vaccine. On 10Feb2021 at 20:00, the patient experienced "brief period of pain in my right bicep, headaches off and on, tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". Treatment for the event "headache off and on" included 2 doses of 2 pills of acetaminophen. No treatment was given for the events "brief period of pain in my right bicep" and "tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". The patient recovered from the events on an unspecified date. The events were assessed as non-serious.
42 2021-02-24 numbness Painful injection site after 10 minutes of injection that lasted for about 2 hours, then it was only... Read more
Painful injection site after 10 minutes of injection that lasted for about 2 hours, then it was only sore. After about 2 hours, I started to had a bad headache and pain and numbness under my left jaw.
42 2021-02-24 pain in extremity A few hours after the vaccine I developed a fever, chills, a headache, muscle pain mainly in the hip... Read more
A few hours after the vaccine I developed a fever, chills, a headache, muscle pain mainly in the hip and thigh area all which lasted about 20 hours. The 2nd day I was a little dizzy with the headache lingering for about 2 days longer
42 2021-02-24 pain in extremity Chills, headache and Fever 100.4 at 9pm on 2/23/2021. Sore arm. Swelling below injection site 2/24/2... Read more
Chills, headache and Fever 100.4 at 9pm on 2/23/2021. Sore arm. Swelling below injection site 2/24/2021. Swelling is spreading further down the arm 2/25/2021.
42 2021-02-24 tingling Tingling to hands and feet X 3 weeks; This is a spontaneous report from a contactable nurse. A 42-ye... Read more
Tingling to hands and feet X 3 weeks; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 19Jan2021 13:00 at a single dose for covid-19 immunization. Medical history included palpitations. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 (first dose). The patient experienced tingling to hands and feet x 3 on 21Jan2021 14:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Feb2021. No treatment has been received for the events. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
42 2021-02-25 flushing Complained of chest tightness, flushed and palpitations, self resolved
42 2021-02-25 flushing 13:50- Approximately 5 minutes after vaccine administered pt became flushed, nauseated and c/o light... Read more
13:50- Approximately 5 minutes after vaccine administered pt became flushed, nauseated and c/o lightheadedness. Patient alerted observer and medical assistant called for transfer of the patient to the first aide office. Patient then evaluated by EMS on duty: VS: b/p 142/80, SaO2 100% on RA. PMHx: Migraines Medications: Fiornial, patient had same s/sx after 1st vaccine. 1435: Patients symptoms resolved and patient was cleared by EMS to discharge home. Ambulated on own without weakness. Escorted out by Paramedic to car.
42 2021-02-25 tingling, numbness Face numb and tingly for several hours; Face numb and tingly for several hours; This is a spontaneou... Read more
Face numb and tingly for several hours; Face numb and tingly for several hours; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date not reported), via an unspecified route of administration at the right arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included carbamazepine and quetiapine. On 01Feb2021 16:00, the patient experienced face numb and tingly for several hours. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date in Feb2021.
42 2021-02-25 speech disorder felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; diff... Read more
felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient) A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room. The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.
42 2021-02-26 difficulty speaking Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatm... Read more
Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatment - self treated with Benadryl (75mg), Zyrtec 10mg. Mild improvement 2 hours later, s/s not completely resolved at time of submission
42 2021-02-26 tremor extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very... Read more
extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very strong have had it all week intermittently. Shaky, racing heart, high BP all intermittent, gastrointestinal upset, headache, feeling run down, trouble breathing but lungs fine Disruptive to working, thinking daily life feel very weird on and off
42 2021-02-27 weakness At 3:40 pm I felt weakness in my jaw and also in the left arm (the one that received the vaccine). ... Read more
At 3:40 pm I felt weakness in my jaw and also in the left arm (the one that received the vaccine). I felt a little dizzy. The weakness in my jaw last aproximately two minutes and the sensation in my arm improved but last a couple of hours more. The dizziness improved at the moment that the weakness of the jaw wore off. I did not receive treatment, because I didn't go to a hospital.
42 2021-02-27 pain in extremity 9 hours after vaccine: Unable to lift arm more than 30 degrees up. 12 hours after vaccine: fatigue... Read more
9 hours after vaccine: Unable to lift arm more than 30 degrees up. 12 hours after vaccine: fatigue 15 hours after vaccine: fever 100.3-100.6. severe body aches. chills. elevated heart rate (100bpm), extreme fatigue. arm pain. unable to sleep 24 hours after vaccine: body aches, fatigue, skin did not want anything on it. general feeling unwell 36 hours after vaccine: fatigue 48 hours after vaccine: no symtoms
42 2021-02-28 cold sweat Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thou... Read more
Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thought fresh air might help. Felt shaky and cold sweats. Was very itchy. No visible rash. Felt a lump in her throat and tightness in her chest. Paramedics sat with her outside. Dizzy and confused and had to sit for an hour before feeling comfortable driving home. Then slept for the entire day. Felt heart palpitations throughout the day. HR was up to 128 at home. 2 days later started to feel better. Felt normal 4 days later.
42 2021-02-28 pain in extremity sore left arm shot area chemosis- thought I had something in my eye, a cat hair since I had been p... Read more
sore left arm shot area chemosis- thought I had something in my eye, a cat hair since I had been petting put cat. skin around right eye slightly swollen. Realized the liquid was under clear part of eye. Looked like some bubbled coming from top of eye, so weird. Could feel the liquid moving in eye when moving head. Touched the eye, liquid spread around iris and pupil not going over it. Was so weird. No pain. Felt that it had to be a reaction to the shot. My body seems to be pretty sensitive. I have had cold sore a few times back to back due to stress. My youngest has Cystic Fibrosis that is what allowed us to get the vaccine, in home caregiver of medically fragile child. Went to urgent care, just needed a professional to say it would go away in a few days and note the reaction. The PA said it was not a reaction to the vaccine, that it is not listed as a reaction in the data. Blah blah blah. I disagreed and left it at that. Had a benedylt last night and put a pataday drop in eye as recommended by PA
42 2021-02-28 pain in extremity Persistent arm and shoulder pain. Cannot lift arm above shoulder without causing pain. Also painfu... Read more
Persistent arm and shoulder pain. Cannot lift arm above shoulder without causing pain. Also painful when laying on the right side. Symptoms have been present since the day of the vaccine. Initial arm tenderness at the vaccine site has gone away.
42 2021-03-01 numbness Received vaccine 1/07/2021. 1/08/2021 had soreness to the injection site and the soreness continues... Read more
Received vaccine 1/07/2021. 1/08/2021 had soreness to the injection site and the soreness continues Numbness then developed 5 days later on 1/12/2021. Numbness starts at the infection site and runs down the arm and numbness extends to the left thumb and part of the left index finger. 1/18 Left thumb ridge started. 1/19/2021 PCP advised take naproxen 500 twice a day, vitamin B12, EKG unremarkable; 1/28/2021 reported to ED 5:00am as began experiencing numbness sensation on the bottom aspect of her face, bilaterally about 4 hours ago while working. Still having persistent numbness in left arm. Arm swelling. CT unremarkable; 1/29/2021 Neurologist believes related to the vaccine and order EMG, treating conservatively; 2/17/2021 had EMG that was unremarkable
42 2021-03-01 tingling, weakness, muscle twitching, numbness About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic we... Read more
About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic were normal. No respiratory distress. After 30 minutes of observation, I left back to my work unit within the hospital and walking back I became dizzy, felt faint and weak. Developed a headache and felt mentally foggy. It lasted about 2-4 hours. No further medical attention seeked at that time. 3 days later at rest at home about 6/7pm, I experienced dizziness, headache, pain to base of neck R side, pain down my spine and lateral back. Numbness to R cheek bone. Twitching to L hand. Numbness, tingling and weakness to L arm. Tightness to chest and back. Emergency department diagnosed degenerative cervical disk disease. Negative on neuro exam.
42 2021-03-02 hot flush 18-19 hours after vaccination, pt experienced chest pain, dizziness, hot flash while at rest. She w... Read more
18-19 hours after vaccination, pt experienced chest pain, dizziness, hot flash while at rest. She was not anxious. She was in between classes of teaching virtually
42 2021-03-02 numbness vaccine @1539 within 5 minutes of vaccine left forearm numbness started. Then progressed to wrist, ... Read more
vaccine @1539 within 5 minutes of vaccine left forearm numbness started. Then progressed to wrist, hand, and fingers. b/p 102/62, hr-58, 02 sat 98% ra. 1601 numbness only on palm of hand. 1642 numbness resolved . b/p 104/60. hr-56, r-18, 02 sat 98%ra. Pt discharged to home with husband.
42 2021-03-02 pain in extremity Pain in legs and joints. A week later, left knee is painful, feels like it has locked up. Struggle... Read more
Pain in legs and joints. A week later, left knee is painful, feels like it has locked up. Struggled to walk on it due to pain for about a week. Taken Tylenol, Ibuprofen, Naproxen but doesn't seem to be effective. Massage helps for a little while. Pain present for 24 hours after first dose. Have not sought care from PCP but will if pain does not resolve soon.
42 2021-03-02 tingling tingling in vaccine arm grey tinge to hand on vaccine arm fatigue pain across shoulders pain down bo... Read more
tingling in vaccine arm grey tinge to hand on vaccine arm fatigue pain across shoulders pain down both sides of spine - Severe pain to adjust head on pillow or shift in bed even the slightest bit felt no need to blink for a few hours slept from 8pm Saturday until 10am Monday - Sleep was the only way to avoid the pain Alleve didn't touch the pain Tylenol began to help after 24 hours low fever around 100.4 skin was super-sensitive to touch swollen lymph nodes in neck on vaccine side swollen lymph nodes under arm on vaccine side - baseball-sized and painful to the touch
42 2021-03-03 weakness Light headed and very dizzy. I had came back to work. I got severely tired. I went home to bed. For ... Read more
Light headed and very dizzy. I had came back to work. I got severely tired. I went home to bed. For the next 2 days I was weak, headache, light headed, dizzy, couldn't concentrate. Nausated. I had covid in November 2020 and it was some of the symptoms I had then. I am very worried about the second shot
42 2021-03-03 feeling hot, tremor, pain in extremity 3/2/21: Shot about 7:30 am I. Arm. 2ish feeling tired and sluggish but not too bad. 4pm low gra... Read more
3/2/21: Shot about 7:30 am I. Arm. 2ish feeling tired and sluggish but not too bad. 4pm low grade fever and tired. 6:30 high fever 103 fever chills, shaking from chills. Lasted about 4 hours. No meds taken to offset. About 11 hot and tired. Hot with fever about 99-100.5. Up and down all night from being sore and not able to get comfortable. As well as feeling hot. Thirsty. Mental fog. 3/3/21: very tired. Wore out by simple tasks. Slept most of day. Achy body. A few slight fever times but not bad. Slept 18 of 24 hours. Times awake we?re just sitting. Mental fog. Even hearing someone else talk would wear me out. Went to bed at 6:30 pm. Was very tired but trouble falling asleep because could not get comfortable so took an Advil pm. Slept until 5:50 only getting up once to use bathroom. Did wake up in puddle of sweat when we to bathroom. 3/4/21: still tired feeling but feel much better. Mental fog way better. No fever. Feel alert and awake. Not feelingwore out by simple tasks. Location of injection: and arm response. Vaccine 1 given was about 2-3 inches down from shoulder joint. Very sore arm for 5 days. 3 days could raise arm or move without it hurting. Vaccine 2 given was no more than 1 inch down from shoulder joint. I was asked to pull T-shirt sleeve up further before getting it. It was much higher in arm than vaccine #1. 2 hours after vaccine arm was very sore. By 4 hours after arm hurt and not able to move it without pain. Did not use arm for even small normal tasks like taking a drink. By time fever broke around 11 pm, Arm felt much better. Sore but no pain to move it or use it for normal activities.
42 2021-03-03 flushing, tingling overall parathesenia, inflammation, red rash, itch, scratchy throat, ?hot throat?, ?warm lungs?, flu... Read more
overall parathesenia, inflammation, red rash, itch, scratchy throat, ?hot throat?, ?warm lungs?, flushing, dizziness; prickly sensations
42 2021-03-03 numbness Pt reported itching on left arm, numbness left hand. MD offered Zyrtec, pt refused.
42 2021-03-03 tremor, flushing nausea, no vomiting. feeling flush, shakey, and anxious. No SOB, pruritis. Moved to a quiet room. ... Read more
nausea, no vomiting. feeling flush, shakey, and anxious. No SOB, pruritis. Moved to a quiet room. Lay down for 45 minutes and observed. symptoms spontaneously subsided.
42 2021-03-04 weakness Woke with fever 102.5, shivering had body aches swollen glands in throat weakness dizzy for 24 hours... Read more
Woke with fever 102.5, shivering had body aches swollen glands in throat weakness dizzy for 24 hours. Then weak following 24 hours. 5days after had menstrual period start even though had just ended prior 2 days prior.
42 2021-03-04 numbness, pain in extremity Post vaccination, pt. complaints of L arm pain and numbness, light headedness. VS 108/72, o2 sat at ... Read more
Post vaccination, pt. complaints of L arm pain and numbness, light headedness. VS 108/72, o2 sat at 97% on RA, HR 76. Pt. alert and oriented, with her husband @1139 patient complained of LA and LL numbness and mild itchiness of the injection site. At 11:58 patient said she feels better and is ready to leave the facility, very mild numbness on the left arm. Health teachings provided with emphasis on following up to their PCP for evaluation or calling 911 PRN. Released with Husband.
42 2021-03-04 pain in extremity Elevated temperature (100.2), body aches, chills, sore arm, extremely swollen auxiliary lymph nodes ... Read more
Elevated temperature (100.2), body aches, chills, sore arm, extremely swollen auxiliary lymph nodes on left side. All symptoms began about 24hrs post vaccine. Swollen lymph nodes and near breast , below armpit stayed very sore and swollen for 5 days. All other symptoms were gone after about 24 hrs (48hrs post vaccine). Treated with ice, cool compress, probiotic, ibuprofen.
42 2021-03-04 pain in extremity Sever GI issues. They have continued for 8 days now. I'm allergic to ALL seafood, and the symptoms I... Read more
Sever GI issues. They have continued for 8 days now. I'm allergic to ALL seafood, and the symptoms I'm experiencing remind me of those: bloody sto, diarrhea, nausea, bloating, stomach cramping. The symptoms started about 30 minutes after the vaccine was administered. It took me this long to figure out it may have been the vaccine. (The above is my main concern. I did also experience a stiff and painful arm which limited my range of motion, and fever. But I expected those reactions. )
42 2021-03-05 flushing Facial flushing, throat tightness, transported to nearest ER by EMS.
42 2021-03-05 numbness, migraine I got the first dose of the Pfizer vaccine on Weds (3/3) at 9am. As I was driving home I noticed the... Read more
I got the first dose of the Pfizer vaccine on Weds (3/3) at 9am. As I was driving home I noticed the left side of my face was numb which stopped after a period of time but ever since I have been having similar numbness on my cheeks and cheekbone. I am also having pretty bad stomach pain. It started Thursday night at 1am and has continued. It started as cramping through my entire tummy and now its burning in my stomach area. I also woke up with a migraine today. Also having chills sweating and fatigue
42 2021-03-05 tingling Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, a... Read more
Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, and proximal > distal LE weakness. Placed on IVIG on 3/4/2021 with improved symptoms of LE weakness but noted residual abnormal sensation
42 2021-03-06 tingling New onset tingling in left hand still continuing 36+ hours after receiving vaccine.
42 2021-03-07 pain in extremity arm pain, fatigue, fever, nausea
42 2021-03-07 tremor, feeling of body temperature change, cold extremities 10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feel... Read more
10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feeling of being hot and cold, sheer panic. Symptoms were very strong for the first few hours after injection. Jittery, shaky, uneasy feeling persisted for about 48 hours.
42 2021-03-08 numbness, discomfort, cold extremities 30 hours after vaccine a warm, red, hard marking, approximately 3 inched in diameter , appeared at t... Read more
30 hours after vaccine a warm, red, hard marking, approximately 3 inched in diameter , appeared at the injection site. Treatment was Ibuprophen and Ice. The next morning the mark spread, appeared lighter, warm and hard to the touch. As the day progressed my arm felt heavy, by the afternoon my arm and hand (not the red spot) felt cold. That evening my shoulder to my fingertips were numb with a "falling asleep" sensation. I still had control of movement but was unable to feel any touch. I wrapped a heating pad around my arm for two hours, unable to feel the heat, and took Ibuprofen and Benadryl. Around 11:00 that night I was able to feel my pinky finger. Continued to apply heat every 20 minutes for 20 minutes throughout the night and continued with ibuprofen and Benadryl. The next morning I was able to feel my ring finger, the red spot had disappeared, and the hardness was decreasing. That evening, continuing with heat, Ibuprofen, and Benadryl, I was able to feel 4 fingers. Continued into Sunday with same treatment and by Sunday morning I was able to feel my entire hand and wrist. As the day progressed I regained feeling up to my elbow and the shoulder by the night. Monday I discontinued treatment. Had full feeling of my arm, with pain in my elbow and shoulder. Tuesday morning all was back to normal.
42 2021-03-09 flushing 4 minutes after the vaccine my heart rate increased drastically. I also felt faint. I stayed with ... Read more
4 minutes after the vaccine my heart rate increased drastically. I also felt faint. I stayed with EMTs for 1.5 hours until I was comfortable to leave. Heart rate came back to normal over this time period. There were still moments when I felt flush/faint-like.
42 2021-03-09 flushing Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen li... Read more
Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen lips
42 2021-03-09 numbness 17 mins after the vaccine I had a weird feeling in both my legs and both my lips went numb (cheekbon... Read more
17 mins after the vaccine I had a weird feeling in both my legs and both my lips went numb (cheekbones down to my chin) and numbness in my fingertips.
42 2021-03-09 numbness and pain in extremities Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensi... Read more
Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensitivity. Going on a week now This was my first vaccine.
42 2021-03-10 weakness, tremor, feeling hot Faint, hot and red head, painful heart, nausea, shaky, dizziness, weakness, headache,, stiff neck.... Read more
Faint, hot and red head, painful heart, nausea, shaky, dizziness, weakness, headache,, stiff neck.It happened about 20 to 30 seconds after shot. After my bandage was on and we were checking why I hadn't received a text reminder to sign up for 2nd dose. Nurses put me in wheelchair and took me to bed. Kept me for 30 mins. Its been 1.5 hours since shot and I'm still dizzy, weak and I have joint pain. I threw up. I still have headache and my heart still hurts.
42 2021-03-11 bell's palsy Bell?s palsy on March 9th Last dose vaccine taken Jan 13
42 2021-03-11 breast pain I experience breast tenderness and eventually soreness approximately 28 hours after my vaccination. ... Read more
I experience breast tenderness and eventually soreness approximately 28 hours after my vaccination. Rest, ice, and motrin helped with the symptoms. Approximately 10 hours after the initial breast pain, the pain/tenderness went away.
42 2021-03-11 muscle spasms Muscle spasms on left side of body (arm, shoulder, leg, face). The muscle spasms are worse in the ar... Read more
Muscle spasms on left side of body (arm, shoulder, leg, face). The muscle spasms are worse in the arm. The spasms are only on the left side of the body. The spasms were worst the night of the vaccine and they have improved, however the spasms are still present.
42 2021-03-11 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Had vaccine shot on Thursday 3/4/21 around 8:50am. The shot spo... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Had vaccine shot on Thursday 3/4/21 around 8:50am. The shot spot was sore for the next couple days and no other symptoms. Then on Sunday 3/7/21 night, I started having pain on the left side of my body (same side where the shot was administered). The pain was mainly from neck to should blade area first for the next couple of days, then it traveled down from my shoulder to my hand. As of the night of Thursday 3/11/21, the pain (comes on when I move my body) gets worse and I was not able to get up from bed without other's assistance. Then throughout this morning Friday 3/12/21, it seems a bit better during the day, with still pain from neck, shoulder, shoulder blade, down to the left arm and hand.
42 2021-03-11 pain in extremity Sore arm starting Tuesday, March 9-March 11.
42 2021-03-11 tremor, pain in extremity Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, f... Read more
Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, flu like symptoms, swollen red knuckles on left hand that were stiff and painful, fainted, dizziness, vision disturbances
42 2021-03-12 numbness After my second Covid 19 shot (administered on 2-12-21), my lower back was so inflamed that the nerv... Read more
After my second Covid 19 shot (administered on 2-12-21), my lower back was so inflamed that the nerves in both arms and my right leg became pinched. I waited one week but could not handle the pain, numbness and inability to feel my arms and legs. I went back to the Medical center and signed into the sick call. They gave me a steroid shot and took X-rays. As of today, 3-12-21, I?m still dealing with pinched nerves in both arms and my right leg. I am waiting to take the X-rays to my spine specialist to see why /how the shot reacted with my spinal fusion.
42 2021-03-12 pain in extremity My arm was sore right away. I got a headache and felt queasy several hours after getting the vaccine... Read more
My arm was sore right away. I got a headache and felt queasy several hours after getting the vaccine. I had a difficult time eating dinner and threw up later in the evening. The next day, my sinuses were stuffed up and I still had a headache.
42 2021-03-12 tingling Approximately 20-25 minutes after injection, dizziness, tingling in face, and throat tightness occur... Read more
Approximately 20-25 minutes after injection, dizziness, tingling in face, and throat tightness occurred, which resolved after about 15 minutes. No shortness of breath experienced and symptoms were not severe enough to seek medical treatment.
42 2021-03-13 inability to speak, cold extremities sharpening to the brain in the waiting area the first 15 minutes and a sharp using to the left hip i... Read more
sharpening to the brain in the waiting area the first 15 minutes and a sharp using to the left hip in the waiting area in the first 15 minutes but I wasn?t too worried about that. Uncontrollable laughter 11:45 AM the next morning. Forgetting where I was going on day two at 2 PM when I went to pick up lunch for the family totally got the wrong lunch. Again with uncontrollable laughter for 8-10 minutes. Sharp pain 05/14/2021 in the ovary area where I have a cyst in my ovary. Words messing up all the time. Right upper chest pain, freezing cold nose and nose tip feels like it?s freezing and has numbness and a runny suddenly on day 3.
42 2021-03-13 numbness Left side of my face doesn?t feel right. Almost numb and my vision to the left is off.
42 2021-03-13 pain in extremity Sore Arm, Exhaustion both for 4 days Headache and Nausea the first day
42 2021-03-14 weakness, pain in extremity, numbness unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Lo... Read more
unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
42 2021-03-14 flushing Severe Flushing (Head, Ears, Neck, Chest) for hours following injection; Slightly subsided after tak... Read more
Severe Flushing (Head, Ears, Neck, Chest) for hours following injection; Slightly subsided after taking Allegra; Flushing came back less severe the following day
42 2021-03-14 nerve pain, feeling hot, tingling significant pain in right armpit lymph node area; Severe nerve pain throughout right upper quadrant ... Read more
significant pain in right armpit lymph node area; Severe nerve pain throughout right upper quadrant of my body, in arm and back (spine); Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; occasional heat sensation; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female non-pregnant patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 26Feb2021 17:30 at single dose in Right arm for COVID-19 immunisation. There was no medical history, no Allergies to medications, food, or other. Concomitant medication included metformin, fish oil, colecalciferol (D3) within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) at the age of 42-year-old, on 29Jan2021 17:30 at single dose in Left arm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe nerve pain throughout right upper quadrant of her body, in arm and back (spine), began the afternoon the day after the second shot on 27Feb2021 03:00 PM and progressed throughout the day, until almost unbearable that evening, even with 800mg ibuprofen. Pain was similar to pinched nerves, with pain, tingling, occasional heat sensation, as opposed to that of a pulled or sore muscle. The patient could not lay in bed that evening and had to sleep upright in a chair with a pillow under her elbow to get minor relief. This pain continued on day 3, but was starting to lessen slightly. Day 2 (28Feb2021), the patient also developed significant pain in right armpit lymph node area, becoming more intense on day 3. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of "severe nerve pain throughout right upper quadrant of my body, in arm and back (spine)", "pain similar to pinched nerves, with pain, tingling" which included 800mg ibuprofen. There was no treatment received for the remaining events. The outcome of the events was unknown. The events were reported as non-serious.
42 2021-03-15 weakness Patient c/o chest pressure and weakness about 10 minutes after receiving the vaccine. She was place... Read more
Patient c/o chest pressure and weakness about 10 minutes after receiving the vaccine. She was placed in supine position, was tearful and lethargic for first 4-5 minutes, never loss consciousness. After 10 minutes in supine position she reported feeling back to normal.
42 2021-03-15 discomfort WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND... Read more
WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND I HAD A RIGHT SIDED FRONTAL HEADACHE. I TREATED WITH ICE PACK, TYLENOL, AND CLAIRITIN. 2 HOURS LATER I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS. tHE SWELLING BROKE DURING THE NIGHT WITH MASSIVE EYE TEARING AND POST NASAL DRIP. I CRAVED BLACK LIC0RICE LIKE MAD.
42 2021-03-15 feeling hot 15: 47pmPt in post Covid vaccine waiting area, 1st dose administered. Pt c/o feeling hot and "my ear... Read more
15: 47pmPt in post Covid vaccine waiting area, 1st dose administered. Pt c/o feeling hot and "my ears are swelling like I'm on a plane". Pt reports having history of "severe allergies" Vital Signs: BP 162/75, HR 122, SPO2 99%. Reassessment 15:52 Vital Signs\ BP 138/84, HR 100, SPO2 99% Nurse alert alarmed, Pt transported via wheelchair
42 2021-03-15 tenderness Immediate large local reaction, 4" area induration/erythema/swelling/tenderness/warmth, no systemic ... Read more
Immediate large local reaction, 4" area induration/erythema/swelling/tenderness/warmth, no systemic sx
42 2021-03-16 depressed level of consciousness Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept f... Read more
Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept for the majority of the last 3 days. I wake up foggy and disoriented. Takes a while to focus and become alert. I use the restroom and maybe I'm able to be active for 15- 20 minutes then I'm back asleep, or too tired to keep my eyes open. Today is the first day I have been able to stay awake more than an hour. I had energy for about an hour and then felt like I was unplugged I'm just too tired to function. All I can do is go back to bed.
42 2021-03-16 nerve pain, tingling, pain in extremity Immediately within minutes after the Pfizer vaccination I got quite painful tingling in the injectio... Read more
Immediately within minutes after the Pfizer vaccination I got quite painful tingling in the injection arm and hand that shot to the face on the same side. Dizziness and bad headache followed. At home a couple of hours later I began to get tingling in the leg on the same side as the injection side was. A day later I had the typical fever symptoms that were not of worry to me. About 7 days later I got neuropathic pain in the arm, hand and leg on the opposite side of the body also. Until this day peripheral neuropathy on both body sides continues.
42 2021-03-16 pain in extremity, flushing ~5 minutes after injection, developed flushing and altered taste. Flushing resolved within 5-10 min.... Read more
~5 minutes after injection, developed flushing and altered taste. Flushing resolved within 5-10 min. Taste was very proncounced, slightly metallic and very salty and lasted remainder of the day with associated nausea. Taste alterations resolved that day. Slight arm soreness and moderate fatigue for next 2 days, then resolved. On day 6, I developed fevers, the odd taste changes that I had post-vaccine returned, and fatigue. Felt "off," similar to when I had presumed COVID in March 2020. Fevers (100.5 on Advil), fatigue, felt "off." No cough/shortness of breath. Symptoms peaked on day 8, then I woke up feeling great on day 9. Minimal reaction to dose #2.
42 2021-03-17 tingling After I received the 2nd vaccine I experienced chills and fatigue for two days. 2 weeks after the 2n... Read more
After I received the 2nd vaccine I experienced chills and fatigue for two days. 2 weeks after the 2nd dose I got a rash of tiny bumps starting around my neck and then spread across my entire body including my scalp. I had inflamed lymph nodes and a cyst near the lymph node was inflamed. The rash continued. I went to my family dr and she gave me 4 days of 20mg prednisone. That helped some. After I finished the medication the rash was healing and then I started having hives that covered my entire body. I am also having 'hotspots' that flare up daily. I have had at least 25 hotspots. my skin stays severely dry no matter what I try. I went back to the dr when the hives started and she gave me a heavy taper down series of prednisone. while it has helped some my body still has hotpots, under the skin is prickly, tingly, and my skin acts like it has been sunburned is is peeling off. I have sores and raw spots randomly over my body. I am also using benadryl to help.
42 2021-03-18 numbness Tiredness (1 week), muscle aches (48 hours) torso numbness in the skin (ongoing), itchy torso (ongoi... Read more
Tiredness (1 week), muscle aches (48 hours) torso numbness in the skin (ongoing), itchy torso (ongoing), swollen and sore lymph nodes under left arm (ongoing), large bump on back (ongoing)
42 2021-03-18 muscle twitching The right side of my nose, mid way up thru the first part of my eyebrow has been twitching/wuovering... Read more
The right side of my nose, mid way up thru the first part of my eyebrow has been twitching/wuovering since Monday evening 3/16 pretty much non stop. I received covid 19 vaccine step 1 on 3/15
42 2021-03-18 pain in extremity A little arm soreness; more tired than normal the day after receiving the 2nd dose of the vaccine.; ... Read more
A little arm soreness; more tired than normal the day after receiving the 2nd dose of the vaccine.; achiness; This is a spontaneous report from a contactable consumer (patient). A 42 -year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown, route of administration unknown in left arm on 15Feb2021 at 09:15 (at the age of 42 years) as single dose for COVID-19 immunisation. Past vaccination included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for immunization on 25Jan2021 at 2:30pm (14:30) in left arm. The patient medical history includes hypothyroid, and the patient has a drug allergy to Bactrim. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine and since the vaccine the patient has not been tested for COVID-19. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced achiness and was more tired than normal the day after receiving the 2nd dose of the vaccine as well as a little arm soreness on 16Feb2021. The patient did not receive any treatment for the events. The outcome of a little arm soreness was not recovered, more tired than normal the day after receiving the second dose of the vaccine was not recovered and achiness was not recovered. Information on the lot/batch number has been requested.
42 2021-03-18 pain in extremity Nasuea, Fever, chills, headache, body aches, swollen lymph node, arm pain for 24 hours that began 14... Read more
Nasuea, Fever, chills, headache, body aches, swollen lymph node, arm pain for 24 hours that began 14 hours after shot continual runny nose since shot, ongoing chills since shot, sore nostril,
42 2021-03-18 tingling Tingling in arm, heart racing 128/80, 80, 18 Patient refused transport informed to follow up with PC... Read more
Tingling in arm, heart racing 128/80, 80, 18 Patient refused transport informed to follow up with PCP if symptoms continue
42 2021-03-18 tenderness, muscle spasms left arm was tender; Cramping feeling and feels like spasms; muscles were sore on the left side; Thi... Read more
left arm was tender; Cramping feeling and feels like spasms; muscles were sore on the left side; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) at the age of 42-years, via an unspecified route of administration in left arm on 31Jan2021 at single dose for COVID-19 immunization, in workplace clinic. Medical history included shell-fish allergy. No other vaccine in four weeks, no COVID-19 prior vaccination. Patient was tested negative for COVID-19 virus test (Nasal Swab) on 25Jan2021. No other medications in two weeks. At 00:00 on 17Feb2021 (16Feb2021 12:00 PM), the patient experienced left arm was tender and muscles were sore on the left side. Cramping feeling and feels like spasms. Patient went to the hospital cause of pain. The adverse events resulted in emergency room/department or urgent care. No treatment. On an unspecified date, COVID-19 was tested post vaccination with unknown results. Outcome of the events was unknown.
42 2021-03-19 inability to speak Within minute of the injection, patient had severe headache. She had dizziness and became very fatig... Read more
Within minute of the injection, patient had severe headache. She had dizziness and became very fatigued. She could not stand up and it was hard to understand her. Within 10 minutes of the injection, patient became very nauseated. They brought her a trash bucket and she hd dry heaved twice. Pharmacist called the EMT around 6pm. The two EMTs took her blood pressure and pulse. Both were extremely high. Blood pressure was 172/96. They recommended that patient should be transported to local ER at the hospital. They put her in the ambulance andtransported her to hospital. She remained at the hospital for 5 hours. Once blood pressure and pulse came down, she was allowed to leave.
42 2021-03-19 burning sensation Pt sat down after receiving her vaccine and felt a burning in her chest that was creeping up to the ... Read more
Pt sat down after receiving her vaccine and felt a burning in her chest that was creeping up to the base of her throat and down her arms. Pt denied trouble breathing, drooling, speaking, or swelling. Paramedics on scene escalated the situation. Pts pulse was 98 bpm with a regular rhythm (12 lead EKG was performed). Pt was hypertensive (BP 177/104). Paramedic on scene continued to use medical language and amplify the situation. An ambulance was called. I offered to have pt wait 10 minutes and then recheck bp, as the rest of her symptoms had resolved. Paramedics encouraged patient that it was "her decision to take the ambulance, however they were concerned about a stroke with a bp that high". Pt left in an ambulance. Will f/u in a couple days.
42 2021-03-19 muscle twitching Light headache and body ache nausea after shot. Then fever started that evening and severe body ache... Read more
Light headache and body ache nausea after shot. Then fever started that evening and severe body aches, twitching, headache, nausea, chills
42 2021-03-19 tingling, numbness, throat numbness Started with a dry throat after 15 minutes -3:45. Thought I just needed water. Drank water in car an... Read more
Started with a dry throat after 15 minutes -3:45. Thought I just needed water. Drank water in car and as we continued to drive my face started tingling and feeling numb. I called the pharmacy at 3:50 and said I should take Benadryl or go to ER if symptoms worsen. I took liquid Benadryl 10ml at 3:55. The feeling continued for the next three hours. The feeling in my throat went away but the tingling feeling continued. On 3/20/2021 I went to urgent care at 9:40am due to continued tingling and numbness in the right side of my face and heaviness in my right arm . I was prescribed prednisone.
42 2021-03-20 tingling About 8 days after I received the vaccine, my arm developed a red, lumpy rash that tingles and is wa... Read more
About 8 days after I received the vaccine, my arm developed a red, lumpy rash that tingles and is warm to the touch.
42 2021-03-21 weakness Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and e... Read more
Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and elbow. my right arm (injection site) is red, swollen, tender and warm to touch"
42 2021-03-21 weakness Following second injection of COVID vaccination in a series of 2 - Syncopal episode approximately 10... Read more
Following second injection of COVID vaccination in a series of 2 - Syncopal episode approximately 10-15 minutes after injection (no history of reaction after first injection.) History of underlying cardiac problems, hypertrophic myopathy, V-Tach. Post injection syncopal episode; patient was bradycardic rate 40, pale, weak, alert & oriented x 4 . Medical staff on site ,care immediately turned over to staff, IV established, Fluids given, BS checked. Sustained bradycardia in 40s for approximately 10 minutes raising to mid 50's following fluid. Patient has a defibrillator/pacer stated that no lower demand set. Pacer for V-tach. Patient stated her defibrillator has fired over 200 times but did not feel defibrillator fire at time of episode. Transferred to Hospital as per patient preference stated this is where cardiologist and records are, cleared through Base prior to transferring. Seen in ED then discharged later that afternoon.
42 2021-03-21 discomfort lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, ... Read more
lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
42 2021-03-21 flushing Flushing, palpitations
42 2021-03-21 pain in extremity pain at injection site up through neck area and down into forearm chills headache body aches fatigue
42 2021-03-21 tingling Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All ... Read more
Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/22/2021 Date: 3/22/2021 Subjective Patient is a 42 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience racing heart and face tingling. She denied rash, difficulty breathing, difficulty swallowing, throat tightness and facial swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, rash, hives, dizziness and headaches +facial tingling: Previous Reactions: Denies Objective Vitals Vitals: 03/22/21 0811 03/22/21 0819 03/22/21 0834 BP: (!) 153/90 134/87 118/85 Pulse: 87 80 80 SpO2: 98% 100% 99% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) Her symptoms completely resolved prior to discharge. PA-C Electronically Signed 3/22/2021 9:02 AM
42 2021-03-21 cold extremities Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the... Read more
Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the next day. Extreme body aches that started in the middle of the night that continued into the next day. Extreme headache which made me nausea until 5PM the next day. Felt 100 percent better on Sunday at 1PM. Vaccine was given on Friday at 1PM.
42 2021-03-21 tremor Progress Notes APRN (Nurse Practitioner) Cosign Needed COVID VACCINE CLINIC Date: 3/22/2021 ... Read more
Progress Notes APRN (Nurse Practitioner) Cosign Needed COVID VACCINE CLINIC Date: 3/22/2021 Subjective is a 42 y.o. female who was seen at today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience shakiness, feeling faint diaphoresis.. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to collapse and rapid progression of symptoms. PMH: HTN (losartan), zoloft and medications for allergies and on ocp. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches + shakiness: Previous Reactions: hx of vasovagal to blood work procedures. Hx to vaccines as well but had not had any problems for a while. Objective Vitals Vitals: 03/22/21 1140 Resp: (!) 58 SpO2: 98% pt refused. states bp measurements make her pass out Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Comments: Hands shaking. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Abnormal findings above improved after laying patient down flat. Pt feels better and was able to progressively sit up in the chair without reoccurrence of symptoms. Assessment/Plan Treatment included: water and rest Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Resolution of symptoms, suspect vasovagal reaction. She is back to base line. Monitored in bay for approx 10 mintues. Pt able to ambulate w/o difficulty or w/ assistance. Pt with husband for discharge. He will drive home. Follow up with pcp as needed. Both patient and pt's husband express appreciation of care today.
42 2021-03-22 pain in extremity I started with a headache at 10pm the day of the vaccine. Throughout the evening I had arm pain, chi... Read more
I started with a headache at 10pm the day of the vaccine. Throughout the evening I had arm pain, chills, sweats, insomnia, joint and muscle pain. All of those things have lasted through today 3/23 and have not improved at all. I feel like I was hit by a truck.
42 2021-03-22 tingling Vaccine admin. At 8:38 am at Vaccine Clinic. The nurse (I?ve forgotten her name - boomer aged, shor... Read more
Vaccine admin. At 8:38 am at Vaccine Clinic. The nurse (I?ve forgotten her name - boomer aged, short gray hair) was standing when she administered the vaccine, and I remember making a note of the whole situation because it was the first time that a nurse did NOT say, ?Relax your arm.? I thought that was odd. I felt nauseous and dizzy within 1-2 min., but after my 15 min. Waiting period was up, I was no longer feeling dizzy or nauseous so I left. Within 10 min. I felt an ache in my arm, deep in the bone, and different then the regular shot-site pain. This is a dull ache that is barely tolerable. A few hours later, my shoulders and neck were experiencing very extreme, sharp pain, and I can barely move my arm, neck, and head. It hurts to hold my head up straight. This pain continues for another 2 days. It is a very intense, throbbing ache, and worse after a fitful night of rest, due to the constant pain in my left arm and neck. 48 hours later, still in intense pain and got a massage. Helped briefly but pain returned within minutes. On day 3, I got another more targeted massage on my shoulders and neck, with only a brief amount of time free from the pain. Day 4, the pain is so intense and I can barely handle it. I make an appointment with a APRN. She does not mention SIRVA but prescribes 800mg of Ibuprofen every 4 hours as needed for pain, and Flexeril, a muscle relaxer. She also gave me a shot of Toradol for the pain. The Flexeril makes me drowsy, and the ibuprofen takes the sharp edge of the pain away, but does nothing to mask the dull, deep ache in my left arm and shoulder. Day 5, 6, 7 all the same. On day 7, a new tingling sensation and numbness in my left hand and fingers start. Contacted office again to request a referral for physical therapy, and also to make a note of SIRVA in my file. Got a prescription for a stronger pain medication; neurontin to hopefully make the pain more manageable.
42 2021-03-23 nerve pain Shingles showed up 4 days after vaccine on side of my nose... diagnosed by my doctor , I?ve been put... Read more
Shingles showed up 4 days after vaccine on side of my nose... diagnosed by my doctor , I?ve been put on antiviral medication. Nerve pain in my neck/headaches on my right side (same side as shingles).
42 2021-03-23 tingling, numbness Tongue, lips swelling, hands and wrists (fingers) numb and tingling. Vaccine administered 1:38pm Be... Read more
Tongue, lips swelling, hands and wrists (fingers) numb and tingling. Vaccine administered 1:38pm Benadryl 50mg PO administered 1:50pm Epi pen given at 2:10pm
42 2021-03-24 feeling cold Light headed and dizzy beginning approximately 10 minutes post vaccination. Swelling of tongue and i... Read more
Light headed and dizzy beginning approximately 10 minutes post vaccination. Swelling of tongue and itching in throat beginning approximately 20 minutes post vaccination. At this point patient notified observation nurse. Assessed by EMTs and nurse practitioner on site. Received injection of 25 mg of Benadryl. Began having relief of symptoms within 3 minutes. No Transported to hospital for observation. Received oxygen during transport. ER gave famotidine and loratadine via pills at 3:44 pm. Observation for approximately 70 minutes. At this point it had been approximately 4 hours since injection. BP and oxygen levels good. No itching. Released and returned home. Patient was cold and tired, which is typical for them when receiving a Benadryl injection. Slept for approximately 14 hours. Currently tired and achy, which is again typical for them after receiving a Benadryl injection.
42 2021-03-24 feeling hot Returned to site after being released post-vaccine, went to car then noted rash to chest area and fa... Read more
Returned to site after being released post-vaccine, went to car then noted rash to chest area and face, +itchiness/warmth to upper extremities. On assessment well appearing, NAD airway intact/denied SOB throat irritation-visible rash (raised/reddened) to ant chest and upper back, warmth to arms bilaterally. Pt requested Benadryl, consultant with on duty Pharmacists who recommended Benadryl-Benadryl 50mg PO give, pt observed x 30 more minutes, all sx's resolved, well appearing. VSAFE hand-out given for self-reporting
42 2021-03-24 flushing 12 minutes post vaccination pt stated she felt "lightheaded " and face "flushed" vitals taken at 153... Read more
12 minutes post vaccination pt stated she felt "lightheaded " and face "flushed" vitals taken at 1534 BP 140/80 HR 91bpm spO2 97% , at 1545 161/71 HR 89 spO2 98% Temp 97.4. Provided water and encouraged deep breathing. Pt called husband to inform him of the situation. She stated she was feeling a little better. Vitals repeated. At 1540 BP 126/65 HR 83 spO2 98% , husband arrived at 1607 and pt left with him and encouraged to check with PCP prior to second vaccination.
42 2021-03-24 tingling Tingling in opposite arm 1 hour after shot, BP 124/82
42 2021-03-24 tremor Body aches; fatigue; chills; headache; rash on hands and arms; shaking; soreness at injection site; ... Read more
Body aches; fatigue; chills; headache; rash on hands and arms; shaking; soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration on 11Feb2021 at 11:00 (at the age of 42-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient previously received acetaminophen, propoxyphene (DARVOCET), cephalexin, and pineapple and experienced allergy. The patient previously received dose 1 of BNT162B2 (lot number EL3249) on 21Jan2021 at 11:00 as a single dose in the left arm for COVID-19 immunization. After dose 2 of BNT162B2, on 12Feb2021 at 04:00 the patient experienced body aches, fatigue, chills, headache, rash on hands and arms, shaking, and soreness at injection site. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of body aches, fatigue, chills, headache, rash on hands and arms, shaking, and soreness at injection site were recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
42 2021-03-25 weakness Feeling nausea, weak, dizzy. Had a brain banana since yesterday. HR 60 reg. BP 106/81, O2 Sat 100... Read more
Feeling nausea, weak, dizzy. Had a brain banana since yesterday. HR 60 reg. BP 106/81, O2 Sat 100%.
42 2021-03-25 tingling, numbness After shot #1 on 3/5/21: tenderness at injection site lasted for weeks. Fatigue on 3/6/21 only. Inte... Read more
After shot #1 on 3/5/21: tenderness at injection site lasted for weeks. Fatigue on 3/6/21 only. Intermittent heart racing. After shot #2 on 3/25/21: pain at injection site. Severe depression and anxiety lasting the day of injection. Intermittent racing heart. Chills, fatigue, overall malaise starting 3/26/21. Moderate headaches starting 3/26/21. Numbness/tingling in tips of fingers on right hand starting 3/26/21.
42 2021-03-25 tingling the patient felt arm tingling after injection.
42 2021-03-26 numbness In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (s... Read more
In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess: - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling. stated she was anxious to get vaccine Left Deltoid site benign, VS 130/72, HR 95 reg strong, resp 12 reg non labored. Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed. Advised if anything occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe . Ok'd to exit 9:45 am
42 2021-03-26 numbness Numbness of the face as if I was coming out of dentist office. Still able to move my face but can no... Read more
Numbness of the face as if I was coming out of dentist office. Still able to move my face but can not feel my skin. Ears felt as if I was underwater or going in plane (trying to pressurize)
42 2021-03-26 tingling 42 YOF c/o tingling in her face. Refused further treatment. No swelling, rash noted.
42 2021-03-26 tenderness Initial soreness went away after 24 hours. Day 6 following the first vaccine my shoulder having join... Read more
Initial soreness went away after 24 hours. Day 6 following the first vaccine my shoulder having joint pain and bicep as well as my armpit has become sore and tender to the touch.
42 2021-03-27 feeling cold, tremor Body aches and pains, joint paint from ankles to jaw, shakes from feeling extreme cold, fever - over... Read more
Body aches and pains, joint paint from ankles to jaw, shakes from feeling extreme cold, fever - overnight rose to 102°
42 2021-03-27 pain in extremity, nerve pain Vaccine injection site high on shoulder. Severe arm pain, injection site bruising and swelling. Ner... Read more
Vaccine injection site high on shoulder. Severe arm pain, injection site bruising and swelling. Nerve pain, fever, muscle soreness, headache, nausea.
42 2021-03-28 burning sensation Sharp shooting pain felt up the left side of my neck when driving to work the next morning after sho... Read more
Sharp shooting pain felt up the left side of my neck when driving to work the next morning after shot. Later in the evening, sharp stabbing/burning pain felt under my left axillary then up the left side of my neck. Then down the left shoulder blade. Continued for several days after. Currently still feel slight burning/skin tearing sensation under left axillary every once in a while.
42 2021-03-28 facial paralysis Slight left side face and lip droop; This is a spontaneous report from a contactable consumer (patie... Read more
Slight left side face and lip droop; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6199), via an unspecified route of administration in left arm on 05Mar2021 08:00 as single dose for COVID-19 immunization. Patient had COVID prior vaccination. The patient had no known allergies and no other medical history. The patient was not pregnant. There were no concomitant medications. There were no other vaccine in four weeks and no other medications in two weeks. The patient experienced slight left side face and lip droop on 05Mar2021 09:30. There was no treatment for the event. The patient was not COVID tested post vaccination. The outcome of the event was not recovered.
42 2021-03-28 feeling hot After receiving dose, she began to feel warm, lightheaded, and nauseous. After ~15 min, she develope... Read more
After receiving dose, she began to feel warm, lightheaded, and nauseous. After ~15 min, she developed swelling in her tongue and took bendardyl (50 mg). Epinephrine was at bedside but not given. Reaction subsided. Vital signs were unremarkable. Physical exam was normal except for tongue swelling.
42 2021-03-28 numbness Sharp pain on the left side of my neck immediately after shot in my left arm. Within 15 mins the le... Read more
Sharp pain on the left side of my neck immediately after shot in my left arm. Within 15 mins the left side of my face and left pinky finger started feeling numb and my left arm was heavy.
42 2021-03-28 pain in extremity Extremem fatigue, some nausea, and right arm soreness.
42 2021-03-28 tenderness Upon injection, I felt a sharp pain, not the same as I had felt with my previous injection. Later on... Read more
Upon injection, I felt a sharp pain, not the same as I had felt with my previous injection. Later on the morning, I saw that the clear bandaid had some blood on it. Later on, I noticed that the bandaid was coming off, when I removed it, it was filled with clear liquid. The amount was to the point that it soaked my bandaid that it was coming off. At this point, I do not know how much of the vaccine was injected in me or how much of it leaked out. Symptoms post vaccination: soreness and a large bump, injection site is red, warm, and pain to touch.
42 2021-03-29 weakness, pain in extremity On Mar, 25th , around 4.30 pm I got vaccinated. I went back home. I ate my summer and Took Tyelenol ... Read more
On Mar, 25th , around 4.30 pm I got vaccinated. I went back home. I ate my summer and Took Tyelenol as I was tired and arm was little sore. I slept around 7.30 pm and got up at 7 am. I felt weakness and after I had my break fast , my body pains started. Every muscle ached and every joint ached. I had weakness and lethargy. I took tyelenol extra strength so the pain was subsiding . I had temperature 100.3 since Fri , Mar 25th. When the tyelenol was wearing off the pains used to become horrible. I was not able to move and I was on my bed bed most of the time. On 28th I even tried Ibuprofen as Tyelenol was not helping a lot with pains but Ibuprofen did not work at all. I sent messages to my dr who thought these side effects are expected. On Mon she replied if the side effects did not resolve I can go to Immediate Care. My arm was sore but that soreness was nothing compared to body aches I had. I called off from work on Fri and Sat. My employer wanted return to work clearance. I went to discuss with Immediate care doctor as I had same weakness and tiredness and little walking was making me breathe heavily. As it was almost the end of 4th day after I got my vaccine they tested me for Covid and my results were negative. I still have to be in quarantine for 7 days from yesterday. I was tested Covid positive in Mar 2020 around mar 24th. I had same horrible pains but had high temperature like 1049.8 and with tyelenol it was 102.5. I am scared to take the second dose that might trigger same reaction. I suffered a lot like people suffered after 2nd dose. First dose is sensitizing dose but I showed such reaction that means my body recognized the threat and began to fight in first dose then what is the need of second dose that is actually a booster dose. My main concern is I might feel the same way how I felt now. I am still weak and cannot perform my daily activities like cooking and I have 4 kids aged 7- 12 yrs age.
42 2021-03-29 weakness Employee began to feel ill at 2am the night following the vaccine. Suffered from weakness, fever/chi... Read more
Employee began to feel ill at 2am the night following the vaccine. Suffered from weakness, fever/chills, nausea, body aches, headache, sweats. Employee missed 3 work days but returned to work once symptoms subsided.
42 2021-03-29 hot flush Nausea, dizzy at times, headache, hot flashes, just in general not feeling well.
42 2021-03-29 migraine Blurred vision, sensitivity to light, migraine headache 10 minutes after injection, heart palpitatio... Read more
Blurred vision, sensitivity to light, migraine headache 10 minutes after injection, heart palpitations within 4 hours of injection. Headache and heart palpitations still present now.
42 2021-03-29 pain in extremity, weakness, tremor extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left s... Read more
extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
42 2021-03-29 pain in extremity, tenderness Swelling of 2nd and 3rd digits of both feet. There was reddish bluish discoloration of the toes. Thi... Read more
Swelling of 2nd and 3rd digits of both feet. There was reddish bluish discoloration of the toes. This was sudden in onset without any trauma. Pulses were intact in both feet. Due to the swelling there was tenderness on the balls of the toes and it was painful to touch. Motrin 200 mg as needed helped relieve it for 1-2 days and then it would recur. The symptoms were present for 6 weeks and thereafter resolved.
42 2021-03-29 pain in extremity arm pain, headache, rash on face neck and chest, fever greater than 101F, fatigue
42 2021-03-29 pain in extremity Soreness in arm within minutes lasting several days, mild fever and lethargy within 24 hours, ibs an... Read more
Soreness in arm within minutes lasting several days, mild fever and lethargy within 24 hours, ibs and stomach intestinal issues resulting in diarrhea that lasted several weeks, vertigo starting 2 weeks after and lasting 5 days and is ongoing at the time of this submission. Slept the first day as soon as I started feeling anything to rest my body. Used pepto bismol liquid and capsules for GI issues. Drank water with electrolytes tabs dissolved in it to restore balance from diarrhea. Don't know how to treat the vertigo. It does not feel like it's because of dehydration but because of certain movements bring it on.
42 2021-03-29 tingling, throat numbness, numbness About ten minutes after the vaccine I had a strange feeling that something wasn?t right. Vaccine arm... Read more
About ten minutes after the vaccine I had a strange feeling that something wasn?t right. Vaccine arm started going numb with tingling. That hand then became completely numb. Then my throat went numb and face was tingling and couldn?t swallow properly. Found nurse at the vaccination site and reported not feeling well. She immediately noticed I was bright red and breaking out in hives. Nurse gave me an antihistamine shot and an oral antihistamine for an allergic reaction. I?ve never had an allergic reaction before or ever experienced any of these symptoms before. After a few minutes the symptoms started going away. I was advised to not drive myself home. About an hour later some milder symptoms came back, such as slight tingling of face and lips. Went away again gradually. Fell asleep (not sure how long) and woke up with swollen and numb lips so I took some more antihistamine. No more allergy symptoms after that.
42 2021-03-30 hot flush Client c/o a flush feeling immediately after receiving the vaccine. Client seen and assessed by EMT... Read more
Client c/o a flush feeling immediately after receiving the vaccine. Client seen and assessed by EMT and VS are:138/95, HR 0, O2 100%. 15 minutes into observation client verbalized that sensation had gone away and was cleared to go by EMT.
42 2021-03-30 numbness, cold extremities, tremor Patient felt lightheaded and felt like her teeth were numb which is common with patients migraines. ... Read more
Patient felt lightheaded and felt like her teeth were numb which is common with patients migraines. Patient had migraine before vaccination and took an over the counter migraine medication before receiving the vaccination. Nurse checked patients vitals 132/88, HR 79, O2 99% on room air. At 5:04 patient started to feel nausea and her legs felt cold. Nurse offered for patient to go to ER at that time and patient wasn't interested. At 5:07pm hand and arms felt cold and she felt a little shaky. Nurse called rapid response in hospital around 5:10pm, at 5:14pm patient was going to ER.
42 2021-03-30 pain in extremity breakthrough bleeding period-wise/this has happened through years; breakthrough bleeding period-wise... Read more
breakthrough bleeding period-wise/this has happened through years; breakthrough bleeding period-wise/this has happened through years; sore arm; extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198) via an unspecified route of administration administered on the left arm, on 23Feb2021 09:45, at a single dose, for covid-19 immunization. Medical history included breakthrough bleeding at times through years. There were no known allergies. Concomitant medication included hydromorphone hydrochloride (DILAUDID) and, alprazolam (XANAX) - both taken for unspecified indications, start and stop dates were not reported. Also as reported concomitant medications included "oxymoron" and "flexibility". The patient did not have Covid prior vaccination. The patient did not receive other vaccines in four weeks. The patient stated it was weird because she experienced a breakthrough bleeding period-wise 12 days after shot, on 07Mar2021 11:00. She stated this has happened through years and; a bunch of women on (social site name) were discussing it and majority had a breakthrough bleeding 1-2 weeks after shot and; that they will also be reporting. The patient stated she has no idea if this was a true side effect, but she considered it strange that so many experienced it too. She also experienced normal sore arm and extreme fatigue - both on 07Mar2021 11:00. Her next dose will be tomorrow, 16Mar2021. The patient recovered from the adverse events on Mar2021 with no treatment received. The patient was not Covid-tested post-vaccination.
42 2021-03-30 pain in extremity very sore left arm; body aches; mild headache; fatigue; This is a spontaneous report from a contacta... Read more
very sore left arm; body aches; mild headache; fatigue; This is a spontaneous report from a contactable consumer (patient herself) of 42-years-old female received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot number: EL3247) via an unspecified route in left arm on 26Jan2021 10:45 am and second dose on 16Feb2021 13:45 pm via unspecified route in left arm both as single dose for covid-19 immunisation. Patient medical history included overactive bladder, premature ovarian insufficiency and known allergies were reported as yes. Concomitant medications were not reported. Patient took other medications within two weeks before vaccination and had not received other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with covid-19 prior to the vaccination. On 16Feb2021 23:30 the patient experienced very sore left arm, body aches, mild headache, and fatigue. The patient was not tested for covid-19 post vaccination. The outcome of the events is recovering.
42 2021-03-30 seizure Vaccine 3/22/21, started with fatigue/generally feeling unwell 3/25/21, fever. Received Tdap vaccine... Read more
Vaccine 3/22/21, started with fatigue/generally feeling unwell 3/25/21, fever. Received Tdap vaccine 3/26/21. Persistent fever, pain around eye, ear and radiating into her head, nausea. Symptoms continued to worsen, developed chest pain and new onset seizure 3/31/21- Sent to ER for evaluation
42 2021-03-31 feeling hot rash and itching on right side of body and face (thighs, stomach arm). Reports "feeling hot." itchy ... Read more
rash and itching on right side of body and face (thighs, stomach arm). Reports "feeling hot." itchy throat. Denies swelling in throat, tongue, lips or mouth. Denies SOB. Reports reaction started 40mn after injection but recalls ears turning "red and feeling hot" within first 15mn of injection.
42 2021-03-31 feeling hot Within 5 or so minutes of injection - Waves of warmth and nausea. Very slight tingling in throat. Sl... Read more
Within 5 or so minutes of injection - Waves of warmth and nausea. Very slight tingling in throat. Slightly elevated heart rate. Dehydration. Treated with benedryl and drank a lot of water and gatorade. Symptoms continued through next day. Body aches within 24 hours of vaccine in addition to tenderness at site of shot.
42 2021-03-31 numbness, tremor Patient with a history of COVID19 infection. She reported onset of L arm numbness, tremor, and heada... Read more
Patient with a history of COVID19 infection. She reported onset of L arm numbness, tremor, and headache. Patient-reported that this was an exacerbation of her now chronic COVID19 symptoms. We discussed the next steps and follow up with COVID19 clinic if she so desired. She was discharged without incident with her husband as the driver.
42 2021-03-31 pain in extremity Muscle aches, chills, feeling of disconnection, sore arm, nausea
42 2021-03-31 pain in extremity Sore arm, body aches, fever, chills, tiredness, headache - second dose (took acetaminophen, slept, r... Read more
Sore arm, body aches, fever, chills, tiredness, headache - second dose (took acetaminophen, slept, resolved 24-36 hours after injection) Sore arm, headache, tiredness - first dose (no treatment, resolved in 24-36 hours after injection)
42 2021-03-31 tenderness * Pain at the injection site & on the evening of 3/30/21, which eventually spread throughout the upp... Read more
* Pain at the injection site & on the evening of 3/30/21, which eventually spread throughout the upper arm. * Pain/tenderness felt in my armpit on the morning of 4/1/21. * Tenderness on the left side of my collarbone, near the shoulder, on the evening of 4/1/21. *The upper arm pain still present.
42 2021-04-01 weakness, cold sweat, pain in extremity few hours after vaccine had headache, very mild sore arm that lasted an hour and red, itchy jaw, chi... Read more
few hours after vaccine had headache, very mild sore arm that lasted an hour and red, itchy jaw, chin neck for a couple hours, The evening after the vaccine was given I had chills, sweats, body aches, fever of 100, the next morning headache, body aches all day and the 2nd day after vaccine I had chills, cold sweats (mainly at night ) but body aches all day, both days very tried and weak. Then after those two days i was back to normal. Same thing happened with my 2nd shot and same timing. i did have covid in the past in august 2020
42 2021-04-01 weakness Pt states she feels dizzy and weak. Pt states she has been fasting and hasn?t had anything to eat. P... Read more
Pt states she feels dizzy and weak. Pt states she has been fasting and hasn?t had anything to eat. Pt was moved to exam area. Pts vitals are stable. Pt was given an apple to eat. Pt states she is feeling better and wants to leave. Pt didn?t require transport to hospital
42 2021-04-01 feeling hot, tenderness, discomfort Patient reported feeling hot, nauseated, heart palpitations, tingling around lips and discomfort and... Read more
Patient reported feeling hot, nauseated, heart palpitations, tingling around lips and discomfort and tingling/numbness/discomfort in left arm within 5 minutes after injection in left arm. (She was negative for lip or oral mucosa swelling, voice change, SOB, rash, visible flushing, urticaria) Her vitals remained stable and initial sx resolved spontaneously within 15-120 minutes apart from swelling (without erythema or induration) and tenderness on left medial anticube, which was treated with ice. Patient had normal ROM, strength of left arm. Patient was observed or 50 minutes and cleared by NP and MD to leave with instructions to FU with ED if return of symptoms. Arm swelling was resolving when called the next day.
42 2021-04-01 flushing Approximately 5 min following injection, pt reported that she felt her uvula was swelling with pruri... Read more
Approximately 5 min following injection, pt reported that she felt her uvula was swelling with pruritus of the throat, and that the back of her tongue was tingling. She reported feeling dizzy, with a flushed sensation in her chest, tingling progressed to entire tongue and to lips. No angioedema or rash on exam, airway clear, VS stable, 02 on RA 96-99% (02 sat increased following admin of epi) HR 106-109, BP 155/90. Administered 0.3mg epi via autoinjector and 50mg diphenhydramine PO. Pt noted sensation in the sensations in her throat, tongue and lips was beginning to subside approximately 10min after admin of medications. Transported via ambulance to CVMC ED for observation and further tx.
42 2021-04-01 pain in extremity, tenderness The day of the injection, my left arm started to hurt, it started out just feeling like a bruise and... Read more
The day of the injection, my left arm started to hurt, it started out just feeling like a bruise and gradually got worse by that night that it hurt to move it and to touch it. The next day it gradually stopped hurting and by the afternoon, it was like an ache, and later it didn't hurt. On 4/1/2021 it was hurting, to touch it it felt like there was a bruise and gradually got worse by 11 pm that night, and hurts to touch and move on 4/2/2021. My arm to look at has appeared normal looking, no bruises, no rash, no redness.
42 2021-04-01 pain in extremity Sore arm for a couple days after shot 1. Sore arm for a few days after shot 2. Body aches, tired, a... Read more
Sore arm for a couple days after shot 1. Sore arm for a few days after shot 2. Body aches, tired, a little fuzzy headed the following day. Sometime in the past few weeks (I'm not sure when) I've developed pulsatile tinnitus in my left ear. It comes and goes. It's not very bad and usually only happens when I'm lying down in bed in the evenings. It feels like there's a little extra ear wax or cotton or something in that ear all the time though. I've never had tinnitus prior to this.
42 2021-04-01 pain in extremity Very sore left arm, chills, runny nose, cold like symptoms, sore throat, body ache, eyes are waterin... Read more
Very sore left arm, chills, runny nose, cold like symptoms, sore throat, body ache, eyes are watering profusely
42 2021-04-02 pain in extremity, cold sweat Sore arm starting late night 4/2. Starting around 9 am 4/3, severe body aches (legs, neck, arm), cl... Read more
Sore arm starting late night 4/2. Starting around 9 am 4/3, severe body aches (legs, neck, arm), clammy feeling, chills starting around noon, slightly nauseous, fever reached 100.9
42 2021-04-02 pain in extremity I had enhanced sense of taste and smell./a heightened sense of smell and taste; I had enhanced sense... Read more
I had enhanced sense of taste and smell./a heightened sense of smell and taste; I had enhanced sense of taste and smell.; I experienced lightheaded and dizziness,; and a headache that feels like pressure/headache; and a headache that feels like pressure, and sinus pressure at the bridge of my nose.; have mild to moderate body aches this morning in my legs and hip bones; have mild to moderate body aches this morning in my legs and hip bones; Shortly after the shot in the medical observation area I experienced mild nausea that went away for the rest of the day.; About an hour after the injection I experienced nasal drainage in the back of my throat that lasted about 30 minutes.; 3 hours after my shot the arm pain at injection site began; followed by 6 hours later moderate to extreme fatigue that did not cause me to be sleepy or drowsy--simply fatigued.; This is a spontaneous report from a contactable consumer (Non-healthcare Professional reporting for a patient). Follow-up received on 05Feb2021 reposted by a consumer was processed together with initial information. A 42-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Intramuscular injection), via an unspecified route of administration in the left arm on 26Jan2021 at 08:45 AM (Batch/Lot Number: EN5318; Expiration Date: Not provided) as a SINGLE DOSE for covid-19 immunisation at the clinic. Medical history included teenage asthma and allergic for Penecillin, mango skin (poison ivy-like contact) and dust mites. Concomitant medications were none. The patient did not receive other vaccines in four weeks. The patient did not have COVID-19 prior or since the vaccination. On 26Jan2021 after the shot in the medical observation area the patient experienced mild nausea that went away for the rest of the day. About an hour after the injection, she experienced nasal drainage in the back of throat that lasted about 30 minutes. 3 hours after the vaccination shot the arm pain at injection site began, followed by 6 hours later moderate to extreme fatigue that did not cause to be sleepy or drowsy- simply fatigued. She had enhanced sense of taste and smell. On 27Jan2021 at 06:00 AM she woke up seeming okay and tried to work from home however she experienced lightheaded and dizziness, and a headache that feels like pressure, sinus pressure at the bridge of nose. She had to disengage from work. After lunch around 2 PM she had extreme fatigue and had to lie down in bed the rest of the afternoon and evening. Dizziness and headache and nausea. On 28Jan2021 the patient woke up with nausea and ate breakfast with a heightened sense of smell and taste. She logged into work and the lightheadedness and dizziness began again. Clinical course of the event was as follows: On 28Jan2021, she woke up with nausea and ate breakfast with a heightened sense of smell and taste. Logged into work and the lightheadedness and dizziness began again (also sort of in waves, though the headache is more pervasive and less wave-like than the nausea), along with waves of moderate nausea and headache. The arm pain at the sight of injection has significantly abated from a punch to mild pain. The "sinus" or sinus pressure on the bridge of my nose seems only a fraction improved. The headache or pressure has moved from the back of my head to the right side of my head. She had no body aches, but that morning she had mild to moderate body aches, in my legs and hip bones. On 29Jan2021, she woke up with 20%-30% reduced symptoms of nausea and headache, but the dizziness and sinus pressure on the bridge of nose remained same. She still had enhanced taste and smell (a sensory plus it's not a distorted or odd enhancement). No treatment was received for the events. Outcome of events was not resolved.
42 2021-04-02 tremor, speech disorder Body Tremors, dizziness, headaches, balance issue, tremors get worse when I feel cold, I blurt out w... Read more
Body Tremors, dizziness, headaches, balance issue, tremors get worse when I feel cold, I blurt out words,
42 2021-04-03 tingling, weakness, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Se... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Spoke with pt around 6:50pm (4/3/2021). she stated she was currently home and feeling a lot better. she denied anymore dizziness, flushing or feeling lightheaded. she is considering coming in with her husband when she comes for the second dose just in case she feels the same way
42 2021-04-03 cold extremities, tremor i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusel... Read more
i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusely; a bout of diarrhea; nauseated; my ears started ringing really loudly, then hissing; could barely stand; my limbs started feeling cold; very thirsty; My pulse felt fast; shaky; My lips and face felt slightly swollen; My lips and face felt slightly swollen; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 42-years-old via an unspecified route of administration, administered in arm right on 18Mar2021 16:15 (Batch/Lot Number: Ep6955) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur dioxide preservative and almost died from blood loss from an unknown date and unknown if ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and venlafaxine hydrochloride (EFFEXOR XR); both taken for an unspecified indication, start and stop date were not reported. The patient reported that right after she left the waiting room, 15mins following the shot, she noticed she was sweating on the drive home, but felt normal, not expecting a problem. Then she felt terrible really fast. She had a bout of diarrhea, was nauseated and her ears started ringing really loudly, then hissing and she felt like she was passing out. She was sweating profusely and could barely stand. She laid down and her limbs started feeling cold and she got very thirsty. Her pulse felt fast it reminded her of when she almost died from blood loss. She felt like she was dying. The feeling lasted about 10 mins, then slowly started fading. She was shaky for the next hour. Her lips and face felt slightly swollen, but there was no itchiness or tightness in her throat. Her temperature was 96.0. She took a nap and woke up feeling better but my ears are still ringing. It has been about 2 1/2 hours. The events occurred on 18Mar2021 16:45. No treatment was received in response to the events. The patient was recovering from the events.
42 2021-04-04 feeling cold Injection site pain (48+ hours & ongoing), tiredness (24 hrs), headache (24 hrs), muscle pain (30 hr... Read more
Injection site pain (48+ hours & ongoing), tiredness (24 hrs), headache (24 hrs), muscle pain (30 hrs), joint pain (30 hrs), chills (12 hrs), fever (4-8 hrs), nausea (20 hrs)
42 2021-04-04 pain in extremity, cold sweat Day 1 (4:30 pm vaccination day). Clammy hands and metal taste for 15 minutes, dizzy feeling for 1 m... Read more
Day 1 (4:30 pm vaccination day). Clammy hands and metal taste for 15 minutes, dizzy feeling for 1 minute. Later that day, overall feeling of unwell, short lived muscle weakness, tired, sore arm, anxiety, loss of appetite, odd, bubbling sensation in left leg, slight itchy skin mostly in legs and at injection site. Day two. Unwell, nausea, loose stool in morning, anxiety, tired, slight sore arm, odd bubbling sensation in left leg, slight itchy skin, loss of appetite, red eyes, red itchy chin, slight itchy skin in legs and at injection site Day three. Unwell, nausea, very slight sore arm, loose stool in morning, panic, tired, itchy red eyes, nausea, red itchy chin, slight itchy skin mostly in legs and at injection site, no appetite. Day 4. Loose stool in morning, more energy but still tired, itching continue slightly on chin and injection site and legs, appetite returning, slightly tired, very slight sore arm. Day 5. Woke up with indigestion, feeling unwell and tired, laid in bed and felt a jolt by means of noise in my head which only happened once and was quickly over, very slight sore arm, itchy at injection site, weird metal taste, upset stomach, leg and arm vein fullness Day 6. Woke up tired with overall feeling of slight unwell but gained a good bit of energy as the day progressed, leg and arm vein fullness. Day 7:. Leg and arm vein fullness Day 8:. Non localized Itchy skin Side note:. I'm beyond worried to get the second vaccination.
42 2021-04-04 pain in extremity Arm sore and tired
42 2021-04-05 cold sweat Brain fog a few hours post-injection 12 hrs to 36 hrs post-injection: Headache, muscle aches, stabbi... Read more
Brain fog a few hours post-injection 12 hrs to 36 hrs post-injection: Headache, muscle aches, stabbing and burning pains in most muscles, severe fatigue, dry mouth/ cracked lips not relieved by fluids, temp of 99.5, cold sweats, chills 36 to 48 hrs: fatigue, residual muscle aches, headache, nausea & belching
42 2021-04-05 numbness, weakness, pain in extremity Initially (24 hours) I had fever 100.5, chills, aches. These resolved by 3/20. Arm was very sore f... Read more
Initially (24 hours) I had fever 100.5, chills, aches. These resolved by 3/20. Arm was very sore for about 3 days, but took almost a week to completely feel better. On 3/21 more concerning symptoms started to develop. Brain fog, spacenesses, trouble looking at books, computer tv. Very strange sensation. This resolved by 3/25. Other symptoms that developed beginning 3/21 were GI upset (diarrhea, stomach churning) as well as insomnia - very short and broken sleep all night with dreams and waking up each time after brief sleep with bad/sour taste in mouth. The insomnia has gotten progressively worse and unlike anything I've had before. I do not have a history of insomnia ( I sleep very well) . For the last week, I do not sleep more than a hour or two at a time and have the broken sleep, with dreams, not a good deep sleep at all, and sour/bad taste in the mouth. I also don't have any history of GI problems. I have been eating a bland diet to try and help with the stomach issues, which have improved somewhat but are still not resolved. The insomnia is very troubling. Also occurring is heat sensation in the right hand (this actually developed after my first shot which was 2/23) that would occur a few times a day where my knuckles are. In the last several days (starting 4/3) my right forearm and bicep have been feeling of weakness and numbness, almost like someone has been sitting on it. Not pins and needles feeling, but weak and numb. This is somewhat transient, and happens for a few hours each day. It seems to have improved as of today 4/6. My physician feels I could have had some kind of neurological response to the vaccine. I would like to know if this could be the case, or if there is any data showing these symptoms will go away, as I am obviously upset by them.
42 2021-04-05 numbness immediately after the injection I felt lightheaded, dizzy and slightly nauseous. After 15 minutes I ... Read more
immediately after the injection I felt lightheaded, dizzy and slightly nauseous. After 15 minutes I stood up and tried to walk and I couldn't feel my feet and lower legs. I was shuffling my feet and was asked to sit down for longer by a pharmacist. I did not experience any pins and needles or tingling. I continued to have a disconnect/limited feeling of my feet for more than 24 hours. I also had continued light-headedness and dizzyness through Sunday (vaccine on Fri) and that's when I called my doctor. The nurse told my I should go to urgent care.
42 2021-04-05 migraine Around 3:30am, I woke up out of sleep with a severe migraine headache the next day following taking ... Read more
Around 3:30am, I woke up out of sleep with a severe migraine headache the next day following taking the 2nd dose of Pfizer shot. It continued to hurt through out the day. Around 1pm after taking a short nap, my body began to ache. Around 4:00pm decided to take 2 alleve over the counter pain pills. They did not work. Overall, symptoms have been severe throbbing headaches, body aches and fatigue.
42 2021-04-05 night sweats Beginning the afternoon of 3/31/21: headache, chills (came and went for 3 days), body aches that wer... Read more
Beginning the afternoon of 3/31/21: headache, chills (came and went for 3 days), body aches that were constant (head/neck/shoulders), soreness in spot of injection, night sweats, fever (came and went), fatigue and loss of appetite. Several days after the onset also had shortness of breath that lasted three days. I finally feel 90% normal on 4/6/21 with just a very slight headache in the morning and slightest tightness in chest. I only took one ibuprofen pill every 9 hours if my symptoms were terrible.
42 2021-04-06 burning sensation, nerve pain At 9pm on 3/6 felt fatigued and went to bed. Awoke at 11 pm with nausea, severe muscle pains, inabil... Read more
At 9pm on 3/6 felt fatigued and went to bed. Awoke at 11 pm with nausea, severe muscle pains, inability to breathe. Crawled back to bed and had fatigue until night of 3/7. Had a temp off 100.7 in the morning of 3/7 that was gone within 2 hours. On 3/8, started waking up to neuralgia in both hands with hands burning and inability to grasp objects. Since 3/8 (continues to this day) this has continued almost nightly and now occurs during the day along with major muscle aches and pain and stiffness in neck all the way down to the back.
42 2021-04-07 burning sensation, pain in extremity Date and time adverse event started: From 1st dose ADE started same day (3/10/2021) at unknown time.... Read more
Date and time adverse event started: From 1st dose ADE started same day (3/10/2021) at unknown time. From 2nd dose ADE started (4/2/2021) approx. 8:30pm Adverse events experienced and are they still occurring now: From 1st dose: patient reported that on same day vaccine was administered (3/10/2021) she had some pain in her left arm so she took Motrin one time same day. The next day (3/11/2021) her left elbow and arm were swollen, sore, painful and she had muscle hardness, patient reported those symptoms subsided 6 days later without taking or applying any treatment. From 2nd dose: approx. a few minutes from rcvding the vaccine on (3/31/2021) she had experienced headache and dizziness, which she reported went away before leaving the vaccine administration site. Then on (4/2/2021 approx. 8:30pm), patient reported that the entire right side of her body from the foot, ankle, leg, armpit, shoulder areas there's burning sensations, and swelling. The left calf is also swollen and hard to the touch. Right arm red rash developed, hot to the touch, swollen, painful and burning sensation. Her left knee gotten red. Stomach pain/cramps. From last night until today, mild headache to right side of her head. What happened as a result of the adverse event? Patient reported for 1st vaccination ADE, she took Motrin one time on 3/10/2021. For her 2nd vaccination ADE, she took only 2 tablets of Bendaryl on 4/2/2021, and stated her swelling went down a little this morning when she woke up. She also reported that the right arm rash, swelling, pain and burning sensation subsided and that the redness on her left knee also went away. As of 4/3/2021, patient reported that her right leg, armpit and shoulder is still swollen, existing burning sensations, still extremely red, hot and hard to the touch. She reported she felt like her pain is not getting better. ***NOTE*** Recommended patient to go to urgent care or the hospital to get her symptoms check out as soon as possible since she stated that her pain and swelling is not getting better on the right leg, armpit, and shoulder.
42 2021-04-07 cold sweat, hot flush, feeling hot About 8 minutes after the shot I started to feel "off" which progressed into lightheadedness and tho... Read more
About 8 minutes after the shot I started to feel "off" which progressed into lightheadedness and thought I was going to pass out. I alerted the pharmacy team right about the 10-minute mark when they increased instead of getting better. Had to sit down, hard to form thoughts, hard to talk without feeling nauseous. Got very hot, had to remove the top layer I was wearing, and put my head down in my hands bc I felt like I was going to get sick. Then around 11:05, the hot flashes turned into a cold sweat, still with the pass out/nausea feeling. Around 11:08 my lower back and hands felt like they were shaking but they weren't. Was given a small bottle of water. At 11:14 the nausea and sweats had passed but it felt like my hands were shaking so badly as if holding a jackhammer. It also felt that my hand muscles were trying to stretch my fingers flat and up, while I was actively trying to cusp my knees. The shaking started to appear in my lower calves but then everything subsided and I was OK to stand up/leave around 11:20. I had some slight brain fog for a few hours and was tired, but was fine come Sunday (aside from site injection swelling and sensitivity that cleared up by Monday).
42 2021-04-07 feeling hot I had my second COVID shot at 10:30AM on March 28, 2021, at 4:30AM on March 29, 2021 I woke up with ... Read more
I had my second COVID shot at 10:30AM on March 28, 2021, at 4:30AM on March 29, 2021 I woke up with chills, body aches and fatigue. I felt like I had a fever. Body aches lasted for about 4 hours. The chills only lasted for a few hours but the fatigue I had lasted 24 hours from the start of the symptoms. After the 24 hour period I was mostly back to normal. I did feel a bit more tired for about one more day. Note: At the time of second vaccine, I was 35 weeks pregnant. My due date is April 27, 2021 but I'm scheduled for a c-section on April 20, 2021. At 36 weeks pregnant, the baby was estimated to weight 7 lbs 9 ozs.
42 2021-04-07 feeling jittery, tingling, pain in extremity After receiving the vaccine yesterday, I started filling amped up like a took a bunch of caffeine pi... Read more
After receiving the vaccine yesterday, I started filling amped up like a took a bunch of caffeine pills but I also had heavy eyes. Very dry mouth. Today I?m in pain from my neck to my hand. My entire arm feels swollen and burning. My hand is swollen and my finger tips are tingly. The severity of this pain started about 4 hours ago.
42 2021-04-07 numbness After 10 minutes, patient complained that her arm had gone progressively numb. I asker her to remai... Read more
After 10 minutes, patient complained that her arm had gone progressively numb. I asker her to remain another 10 minutes and there was no improvement. She wanted to go home, so I told her that I would call her in 2 hours. When I spoke to her 2 hours later, the arm had returned to normal with no impaired function
42 2021-04-07 migraine, hot flush After shot was given I felt like hot flash and then an hour later could not hold head up need to be... Read more
After shot was given I felt like hot flash and then an hour later could not hold head up need to be sitting next to AC/Fan. I got a headache and the next 2 days had a migraine could barely open eyes.
42 2021-04-07 muscle spasms, tremor Chills, feverish, rash, spams in arm, hand trembling. possible diarrheas, headache, fatigue, blurred... Read more
Chills, feverish, rash, spams in arm, hand trembling. possible diarrheas, headache, fatigue, blurred vision, loss of focus, general malaise and body pain.
42 2021-04-07 muscle twitching My nerves are twitching in and off in my legs . Unbearable. I got really sick the day after with chi... Read more
My nerves are twitching in and off in my legs . Unbearable. I got really sick the day after with chills , fever and body aches and nerve twitching. Sickness is gone but nerve twitching doesn?t go away or lessen. It?s all the time I can?t even drive.
42 2021-04-07 pain in extremity, muscle spasms It started with pain throughout my arm and left side within minutes of the injection. Within two hou... Read more
It started with pain throughout my arm and left side within minutes of the injection. Within two hours my limbs were weak and my muscles were sore. By 5 hours after the injection my muscles were cramping or slightly spasming, my skin felt bruised or like it was sunburned, and any contact, even with clothing was incredibly uncomfortable. I itched everywhere, but scratching did not ease it, because it seemed to be coming from under my skin. I could not cool off, again, it was like having a severe sunburn. This subsided for the most part within a few hours. The next morning I felt better, though I still had muscle/joint aches, until about 1 in the afternoon, so about 17 hours after the injection, when I became very tired. Within another hour a fever, headache, and flu-like symptoms set in. They continued for about 24 hours. After the first two days the muscle/joint pain and headache were all that lingered, but extreme fatigue would come over me in waves, and I would need to sleep for several hours at a time throughout the day. This lasted for three additional days.
42 2021-04-07 pain in extremity, tenderness, tingling, numbness Awakened with throbbing pain in the entire left arm (shoulder to fingertips). Numbness/tingling in l... Read more
Awakened with throbbing pain in the entire left arm (shoulder to fingertips). Numbness/tingling in left ring and pinky finger. Tenderness/swelling in the left armpit. Aching arm followed for a few days, but axillary swelling persisted for about 10 days. Occasional tingling in fingers is still present 2 weeks later.
42 2021-04-08 discomfort LIGHTHEADED, METALLIC TASTE IN MOUTH, MILD ITCHING ON LEFT SIDE, HEAVINESS IN CHEST AND GUT. NO SHOR... Read more
LIGHTHEADED, METALLIC TASTE IN MOUTH, MILD ITCHING ON LEFT SIDE, HEAVINESS IN CHEST AND GUT. NO SHORTNESS OF BREATH. TWO SYNCOPAL EPISODES, NO IMPROVEMENT IN SYMPTOMS AFTER 10 MINUTES, TRANSPORTED TO HOSPITAL.
42 2021-04-08 slurring PATIENT'S HUSBAND SAID SHE WAS FEELING REALLY SLEEPY. I ASKED IF SHE WAS NERVOUS BECAUSE SHE JUST S... Read more
PATIENT'S HUSBAND SAID SHE WAS FEELING REALLY SLEEPY. I ASKED IF SHE WAS NERVOUS BECAUSE SHE JUST SAW ANOTHER PATIENT FAINT AND SHE SAID YES. SHE FAINTED JUST AFTER THAT AND HER HUSBAND HELPED ME MOVE HER TO THE FLOOR. SHE WAS STILL BREATHING BUT SHE WAS IN AND OUT OF CONSCIOUSNESS SO WE CALLED 911. PATIENT WAS RESPONDING TO CONVERSATION BUT WOULD SLUR SOMETIMES AND EYES WOULD ROLL BACK AS SHE LOST CONSCIOUSNESS AGAIN. PLACED COLD COMPRESS ON FOREHEAD AND BACK OF NECK. PATIENT'S HEART RATE WFLUCTUATED THE WHOLE TIME. PARAMEDICS CAME TO ASSESS HER, BLOOD PRESSURE WAS HIGH 180 SYSTOLIC (DIASTOLIC WOULDN'T READ), AND SUGAR WAS 401. PATIENT DECIDED TO GO TO ER VIA AMBULANCE AFTER SHE ALMOST FAINTED AFTER STANDING.
42 2021-04-08 feeling hot, flushing Pt received the 1st dose of Pfizer COVID-19 vaccine on 4/8/21. Prior to administration, pt reported ... Read more
Pt received the 1st dose of Pfizer COVID-19 vaccine on 4/8/21. Prior to administration, pt reported to vaccinator that she has a hx of allergic reactions (no anaphylaxis) and sees an allergist. Pt reports that her allergist has her come to the Allergy Clinic for the flu vaccines and to be monitored. Vaccinator escorted pt to check-out and reported to me that pt should remain for 30 minutes of observation d/t reported hx. Pt sat in observation for about 10 minutes and began to feel very warm. Volunteer from Observation group alerted RN who was volunteering as a vaccinator. Staff notified me and I joined in the recovery room with the pt. Pt appeared very flushed and we observed redness and some red bumps on her face and neck, Pt chest appeared red, as well. Hx of allergies to shellfish, cats, seasonal and others yet unidentified. Applied cool cloth to back of neck, and gave juice and crackers. Vitals: 12:10pm-- P-98, BP-120/88, O2-98% on RA 12:25pm--P-98, BP-131/91, O2-98% on RA Due to slight increase in BP and not seeing resolution to the flushing, it was determined to give Benadryl. 25 Mg Benadryl, PO @ 12:30pm Vitals @ 12:45pm: P-84, BP-91/56, O2-99% on RA Flushing resolved and pt reported she felt well enough to go home. Discussed plan to get to urgent care STAT is she experienced worsening symptoms, especially difficulty swallowing and/or facial swelling. Pt informed that a VAERS report would be filed and she may be contacted by this agency as they collect data on immunization reactions. Pt is agreeable. Compass-Safety report will also be filed.
42 2021-04-08 feeling hot Patient duress and coughing uncontrably, heat stressed and being fanned, sweating. Onsite EMS was ca... Read more
Patient duress and coughing uncontrably, heat stressed and being fanned, sweating. Onsite EMS was called vitals HR 98 BP 134/82. Vitals HR 88 BP 131/83. She went home.
42 2021-04-08 pain in extremity Sore arm immediately following vaccination. Lasted approximately 24 hours after onset and then resol... Read more
Sore arm immediately following vaccination. Lasted approximately 24 hours after onset and then resolved. Headache approximately 3 hours after vaccination. Laid down periodically and took ibuprofen; neither improved headache. Headache lasted approximately 24 hours after onset then resolved.
42 2021-04-08 pain in extremity Initially soreness in arm of vaccination site (left upper arm). Then breakout of hives and intense i... Read more
Initially soreness in arm of vaccination site (left upper arm). Then breakout of hives and intense itchiness which began in a small location and gradually spread to multiple locations throughout my body from the neck down.
42 2021-04-08 tenderness axillary adenopathy on same side as vaccination, tender
42 2021-04-09 numbness, pain in extremity -Recieved shot about 3pm -During the 15 min waiting period my eyes felt kind of dry and "weird". I ... Read more
-Recieved shot about 3pm -During the 15 min waiting period my eyes felt kind of dry and "weird". I honestly didn't even consider it could be a reaction, I thought the way I was breathing through my mask must have been drying my eyes out. -Left clinic after 15 mins, only symptom at this point was dry eyes -about 5 mins in to our drive home my face was feeling very funny and kind of numb. I was feeling worse and worse. -looked in mirror and noticed face was bright red and swelling up. Also my throat was fire red. -it was getting worse and worse, also was starting to get itchy. -My entire face was bright red -Stopped at Sister-in-law's house (cause it was on the way home and she is a nurse) and took two benadryl. Was observed for another 20 mins there and the reaction started to calm down. The redness was still there, but the swelling seemed to have stopped. -went home and kept a close eye on it the rest of the night. -became itchy, but no rash. The bright redness went away after about 20 mins, but my face stayed red (like a sunburn) most of the evening. Throat was red as well. -felt fine when waking up on 4/9 and no other instances of these symptoms -sore arm 4/8-4/10
42 2021-04-09 muscle spasms Vaginal bleeding and cramping similar to menstruation the same night as second dose was administered... Read more
Vaginal bleeding and cramping similar to menstruation the same night as second dose was administered. Last menstrual cycle was on 11/06/2020. No period since then (due to birth control). On 03/27/2021 I started bleeding and thought how weird after all this time of not having it. The flow is light throughout the day but when go urinate there are little blood clots almost every time. The cramps are sporadic and the bleeding is going on 2nd full week without no break in between as of this date.
42 2021-04-09 pain in extremity My arm was very sore almost immediately after injection. the next day my arm pit and left breast and... Read more
My arm was very sore almost immediately after injection. the next day my arm pit and left breast and area under left arm on body- were very swollen and sore. Maybe its the lymph nodes? I couldn't lift my arm. 10 days later and feels better but still have swelling and pain, lessens every day
42 2021-04-10 weakness Pain radiation from injection site up are to shoulder blades down spine Extreme sweats and cold chil... Read more
Pain radiation from injection site up are to shoulder blades down spine Extreme sweats and cold chills 102.2 fever off and on for 3 days Extremely weak and tired from Monday first night of first dosage until almost Saturday 5 days later
42 2021-04-10 discomfort, numbness I was find after the 15 minute waiting period. By the time I had pulled out of the complex in my ca... Read more
I was find after the 15 minute waiting period. By the time I had pulled out of the complex in my car my cheeks were bright red and it continued down my neck. My right side of neck felt tight/stiff. By the time I got home I had a hive above the right clavicle. Right hand felt numb. Heart rate accelerated, face became puffy. Lips and gums felt numb, throat got red and swollen, hive on right gum and back of throat felt itchy. Never lost ability to breath or swallow. High anxiety, felt extremely uncomfortable in my body. Took Histaminum hydrochloricum via bioAllers Pollen Hayfever treatment several times between 6:30pm and 10pm. Took Skullcap via tea between 7pm and 8pm. Reaction started to calm down around 8:45pm, and I felt back in my body by 10pm. It took until about 2:30am until my heart beat regulated. I will see a PCP hopefully today (Sunday) if not tomorrow.
42 2021-04-10 numbness Numb face about 30 minutes after shot - returned to facility for observation.
42 2021-04-10 numbness 42 y/o female, hx of fainting ?when getting shots?. c/o SOB, stated ?I feel numb on my face from nos... Read more
42 y/o female, hx of fainting ?when getting shots?. c/o SOB, stated ?I feel numb on my face from nose down to my mouth?. Also stated ?I feel like my throat is closing and having hard time swallowing?. Pt is hyperventilating, crying. Paramedics V/S taken HR 95, BP 149/88, O2 Sat 100%. Educated on calming and deep breathing techniques, given po fluids tolerating well. Pt now more calm and sent home without s/s acute distress.
42 2021-04-10 tingling, numbness, pain in extremity Injury to left shoulder, pain in left shoulder and arm, weakness in left hand and arm, and numbness/... Read more
Injury to left shoulder, pain in left shoulder and arm, weakness in left hand and arm, and numbness/tingling/pins & needles sensation in left hand for more than 2 weeks after receiving my second vaccine shot. Pain has made it difficult to sleep, drive, sit up, etc. Also experiencing pain in back of lower neck due to pain posture. Just started physical therapy and was prescribed high-strength ibuprofen to deal with the pain. Experienced no pain when I received my first Covid shot, but when the vaccine administrator gave me my 2nd shot, it hurt very badly going into my arm, and it seemed like she injected me in a location that was different from my first shot.
42 2021-04-11 cold sweat Patient presented to pharmacy to received covid-19 vaccine after her doctor asked her to received va... Read more
Patient presented to pharmacy to received covid-19 vaccine after her doctor asked her to received vaccine due to HTN, DM chronic diseases. Patient received vaccine around 1:05pm and proceed to waiting area within less than 5 minutes patient started to feel sick and experienced nausea, cold sweats, and palpitations. Assisted patient taking BP, 1st reading 195/72 HR:124, 2nd reading 106/67 HR 96. EMS arrived to pharmacy and patient was taken to hospital.
42 2021-04-11 facial pain, night sweats The night of the vaccination I began having fevers night sweats and radiating severe Right neck pain... Read more
The night of the vaccination I began having fevers night sweats and radiating severe Right neck pain that radiates from my neck to my right ear up my R scalp and R front and to the top of my head causing severe chronic headaches constantly. So far it has last for seven days with minimal relief and it is worse at night when I try to sleep causing me insomnia due to pain. Pressure in my head feels like my brain is about to explode and I feel it in my neck and back of my ear on the right side.
42 2021-04-11 numbness, weakness, tingling Approximately 3-5 minutes after receiving shot, I experienced rapid heartbeat, rapid deep breathing,... Read more
Approximately 3-5 minutes after receiving shot, I experienced rapid heartbeat, rapid deep breathing, light tingly and numbness on my lips and feet and mild stomach weakness. I was immediately attended by the fire rescue on site who took my heart pulse and blood pressure. After leaving the location I experienced two more episodes of the same symptoms within 1 hour of receiving the vaccine. After that I have been okay. I would like to know if after having experienced these symptoms should I still receive the second dose.
42 2021-04-11 pain in extremity 04/08/21 - Pain at injection site, Fever (100.4*F), Fatigue 04/09/21 - Pain at injection site and ar... Read more
04/08/21 - Pain at injection site, Fever (100.4*F), Fatigue 04/09/21 - Pain at injection site and arm, Fever (100.0*F), EXTREME Fatigue, Joint Pain, Body Aches, Dizziness (Did not go to work) 04/10/21 - Dizziness, No fever, Fatigue, Joint Pain, Nausea 04/11/21 - Large Joint Pain, Fatigue, Pain in Left Shoulder near injection site 04/12/21 - Large Joint Pain, Fatigue, Pain in Left Shoulder near injection site
42 2021-04-11 pain in extremity Day 1 I had pain in the arm consistent with other vaccines I have received. It only hurt when I move... Read more
Day 1 I had pain in the arm consistent with other vaccines I have received. It only hurt when I moved my arm. It lasted a couple of days and then went away. After that pain stopped a aching pain started on Day 4 or 5 and continued to get worse. I was in significant pain constantly for several days (NOT just when moving my arm) and ice and pain meds didn't help. It finally started to subside on Day 8 and Day 9 I was pain free.
42 2021-04-11 pain in extremity sore arm muscle, chills
42 2021-04-11 tingling Redness; swelling; large knot at injection site; swollen lymph nodes in armpit in injection; tinglin... Read more
Redness; swelling; large knot at injection site; swollen lymph nodes in armpit in injection; tingling down to fingertips of arm injected; shortness of breath and heart palpitations.
42 2021-04-11 tingling An hour after I received the vaccine, I became light-headed and started feeling tingling in my upper... Read more
An hour after I received the vaccine, I became light-headed and started feeling tingling in my upper body. My lips were tingling and became numb. My throat also started to feel tight. I did receive Benadryl IVP 25mg within 5 minutes of reaction.
42 2021-04-11 tremor Shaking uncontrollably. Feverish still
42 2021-04-12 weakness Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. The next day, she developed fever, was ... Read more
Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. The next day, she developed fever, was told that she had a sinus infection, and was treated with amoxicillin. Patient tested positive for COVID on 4/7/21 at her primary care doctor's office. On 4/8/21, patient presented to the ER with cough, shortness of breath, fever, chills, and weakness, but was sent home. Patient returned to the ER on 4/9/21 with worsening symptoms and was admitted to the hospital for COVID treatment.
42 2021-04-12 flushing, tingling Prior Hx of anaphylaxis. Tingly feeling bilateral of face/jaw described as moving up and down. Patie... Read more
Prior Hx of anaphylaxis. Tingly feeling bilateral of face/jaw described as moving up and down. Patient visibly anxious before and after vaccine administration. Vital Signs: BP 151/121 HR 93 Resp 18 O2Sat 94 Skin Signs: Other - flush A/Ox4 Circulation: Cap refill <2sec Respiratory: Diminished bilateral Initial Treatment: Observation. Family doctor: Dr. (local) 1:19 PM Vital Signs: BP 136/90 HR 98 Resp 12 O2sat 96 Skin Signs: Other - flush, dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: Continue observation. Patient visibly more calm. Hx of hives with influenza vaccine. A/Ox4. No obvious distress, No increased resp effort. Advised patient to have discussion with family doctor before second dose. Tingling reduced by 1:28 PM. 1:31 PM Vital Signs: BP 132/102 HR 88 Resp 12 O2Sat 96 Skin Signs: Warm and dry Respiratory: Breath sound clear bilaterally Follow up Treatment: 'Tingly' feeling moved to lower jaw and decreased in intensity at 1:34 PM. Notes: 1:43 PM call placed to Dr. - Related patients vitals to RN. 1:48 PM patient denies 'tingly' feeling. No SOB or difficulty swallowing. Stated she feels 'normal again'. Disposition: Home with husband at 1:57 PM.
42 2021-04-12 numbness Received shot at 12pm. Symptoms started at 2pm and progressed rapidly, within an hour. Headache sta... Read more
Received shot at 12pm. Symptoms started at 2pm and progressed rapidly, within an hour. Headache starting on left side of forehead, moved across forehead to above right eye. Right ear then became plugged, and sharp ear pain in right ear when swallowing. Upper and lower teeth on right side of face began to ache. Right side of face became numb. Took Aleve and laid down in bed at 4:30pm, and fell asleep. Woke up at 8:30pm with all symptoms resolved except for the plugged ear (without pain), which was resolved the next morning when I woke up.
42 2021-04-12 pain in extremity I received my 1st vaccination on Friday, April 2nd. Minutes after receiving the vaccine, my throat s... Read more
I received my 1st vaccination on Friday, April 2nd. Minutes after receiving the vaccine, my throat started itching and feeling tight. I stayed for 30 minutes and the reaction never got any worse. Luckily, my airway was never blocked nor my breathing impaired. I went home, took 2 Benadryl, and about 2 hours later I went to bed and slept for 13 hours (approx). My throat was still a little tight that Saturday and my left arm was really sore, but by Sunday I felt completely normal.
42 2021-04-12 pain in extremity 4/9/21, just a sore arm and tired the same day Day 2-2.5: tired and little headache, sore arm, some... Read more
4/9/21, just a sore arm and tired the same day Day 2-2.5: tired and little headache, sore arm, some body aches Monday &Tuesday (4/12/21 --4/13/21) Had to miss work. Temp 99 on 4/13. VERY fatigued. Unable to regulate body temp. Hot and cold. Joint pain., body aches, excessive thirst, brain fog.
42 2021-04-12 speech disorder, night sweats, feeling cold Shot #1- Rushes of very intense anxiety, massive headache, extreme light sensitivity, loss of taste ... Read more
Shot #1- Rushes of very intense anxiety, massive headache, extreme light sensitivity, loss of taste & strange feelings in mouth, intense inability to rest, chills and then soaking my bedding with sweat, and then a crippling multi-day depressive bout which was extremely atypical for me. Shot #2- similar schedule, several hours after my shot I began to feel intense rushes of anxiety, a bit of a sore throat this time, this find the anxiety just completely took over in the night and I was writhing and thrashing, freezing cold but sweated through FIVE pairs of pajamas straight, absolutely could not get any rest or relief. Dizziness upon standing. The next day so utterly depressed and unable to move. No headache, no fever, but a very alarming ?cloud? or fog in my brain. Unable to communicate, dropping things, couldn?t complete a simple task, very frustrated and would burst into tears unprovoked. NOT AT ALL typical behavior for me. This went on for three days and I have not felt so low since the 90s when I was a pubescent teenager.
42 2021-04-12 tremor Vomiting, diarrhea, and nausea. Also some shakiness. Onset of nausea and vomiting approximately 7 ho... Read more
Vomiting, diarrhea, and nausea. Also some shakiness. Onset of nausea and vomiting approximately 7 hours after vaccine, lasted about 12 hours with no ability to keep in fluids, still some lingering nausea after that.
42 2021-04-13 numbness, tingling Tingling/numbness in fingers occurred within 30 minutes and lasted a day (happened with 1st and 2nd ... Read more
Tingling/numbness in fingers occurred within 30 minutes and lasted a day (happened with 1st and 2nd doses). Red rash occurred at injection site an hour after 2nd dose and doubled in size the next day. Rash is very hot to the touch.
42 2021-04-13 tingling, unresponsive to stimuli, tremor, flushing Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic:... Read more
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported anxiety with needles, blood work, vaccines. She experienced lightheadedness, dizziness, and needed to lie down. Bendaryl was given 50 mg and patient recovered. Cold packs applied to back of neck, water given. Likely an axiety induced response.
42 2021-04-14 breast pain I developed a painful lump on my left breast, around 2 weeks after my first shot.
42 2021-04-14 numbness, tingling rash, redness on both arms, face and ears immediately after vaccine. Pin and needles and numbness on... Read more
rash, redness on both arms, face and ears immediately after vaccine. Pin and needles and numbness on the fingers within a couple of minutes. Then pain on right side of body radiating down to liver 5 to 10 minutes after and lasted for several days. Despite taking Tylenol. patient still experiences soreness on the right side of body where liver is up to now.
42 2021-04-14 pain in extremity, tingling On 3/27/2020, the patient received the second dose of the Pfizer COVID vaccine. About 3 hours later... Read more
On 3/27/2020, the patient received the second dose of the Pfizer COVID vaccine. About 3 hours later she started to develop paresthesias in both hands and fingers, as well as pain. She continued with the same paresthesias and pains; in about a week, she developed subungual hemorrhages
42 2021-04-14 seizure Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was exper... Read more
Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was experiencing SOB but all blood work normal - assumed normal SOB with pregnancy. Night/morning of 4/15 started seizures, transported to ED. Diagnosed with massive pulmonary embolism. Emergency C-section prerformed by Dr. Pt. did not survive.
42 2021-04-14 tremor Near syncope slight tachycardic-90's sudden episode of shaking
42 2021-04-15 burning sensation Patient received the first shot of the COVID-19 Pfizer vaccine in the L arm on 4-6-21 at Hospital, a... Read more
Patient received the first shot of the COVID-19 Pfizer vaccine in the L arm on 4-6-21 at Hospital, and within 15 seconds reported a ?warmth? or ?burning? sensation in L arm, axilla, shoulder, chest, and stomach, and an almost immediate ?metallic taste? in her mouth. Shortly after she felt an increase in her heart rate. Approximately 30 minutes later she says she experienced nausea and like her ?tongue was swelling.? She went home and took a Benadryl and all symptoms had resolved within 30min-1hour. The following day (4-7-21), she was ?achey? and had low grade fever (Tmax 100.5F reported). That night (4-7-21), she felt like her axillary region was slightly sore or starting to swell, but woke up 4-8-21 to severe swelling, warmth , visible bruising, pain, tenderness, all in the L axillary region, so sought care at our office. She did have visible and palpable swelling under the L axilla, and it appeared her vaccine was given in the proper location and there was no local induration/warmth/tenderness at the injection site. She felt the same on 4-9-21, and by 4-12-21 all the axillary symptom had resolved and she only had sore lymph nodes under her jaw. By 4-14-21 all symptoms had resolved other than one small slightly tender lymph node under her jaw.
42 2021-04-15 numbness pt sat for vaccine and then noticed arm feeling numb, pt waited 15 minutes and proceeded to walk to ... Read more
pt sat for vaccine and then noticed arm feeling numb, pt waited 15 minutes and proceeded to walk to exit with husband and when ambulating pt felt numbness and weakness in legs notified staff and placed in wheelchair and taken to OBS. pt states didnt take her iron this morning and once sitting down feeling better only feeling numbness on and off in arm. pt given water vs as noted. denies further symptoms pt dangled and then stood at side of bed with no further weakness feeling in legs pt ambulated to exit accompanied by husband, mother in law and son at 1212 vs 1203 bp 115/74 hr 64 rr 18 o2 100 1208 dangle bp113/75 hr 57 rr 18 o2 100 1210 standing bp 125/79 hr 70 rr 18 o2 96
42 2021-04-15 pain in extremity 4/14/21. Vaccine administered at 9:05am. Around 4pm fatigue set in. My left arm was sore. Low ap... Read more
4/14/21. Vaccine administered at 9:05am. Around 4pm fatigue set in. My left arm was sore. Low appetite. 4/15/21 Still fatigued. I had chills and a headache (no fever). Soreness of the left arm. Low appetite. 4/16/21 Energy has improved but still tired. Left arm feeling better. I did not seek medical attention.
42 2021-04-16 migraine, numbness and pain in extremities, inability to speak Migraines resistant to OTC NSAIDs. Pain phases lasting multiple days, with multiple nausea, aphasia,... Read more
Migraines resistant to OTC NSAIDs. Pain phases lasting multiple days, with multiple nausea, aphasia, visual disturbance, and facial neuropathy phases. Pain phases will break after 3-4 days, followed by extreme tiredness, then onset of a new pain phase 1-2 days later.
42 2021-04-16 pain in extremity Headache within 2 hours that lasted all day. 24 hours after shot - headache, fever, body aches fati... Read more
Headache within 2 hours that lasted all day. 24 hours after shot - headache, fever, body aches fatigue lasted 12 - 16 hours. This morning (22 hours after shot) woke up with a lump in my armpit of my right arm. Arm soreness within 15 min of shot and continues.
42 2021-04-16 tremor Very sudden onset of Hugh fever 103.9 and uncontrollable shaking and shiver as well as complete feel... Read more
Very sudden onset of Hugh fever 103.9 and uncontrollable shaking and shiver as well as complete feeling of being totally out of it.
42 2021-04-17 discomfort, tingling, nerve pain 10 days after 1st dose, started with severe itching burning tingling on left flank early morning. F... Read more
10 days after 1st dose, started with severe itching burning tingling on left flank early morning. For a few days prior had headaches as well that would keep coming back. Was able to get into see primary next morning, confirmed shingles, prescribed valacyclovir 7 day course. As days progressed red rash appeared, also along that and up left back flank greenish yellow bruising as well. Meds help stop progression of blistering, blisters did not appear. It has been about seven days now. Today, Sunday 4/18/21, I went to ER for mid upper thoracic spine pain discomfort and into chest, weird heavy inflamed feeling in chest, little shortness of breath. This pain and feeling been going on for few days or more. ER Doc did not do xray of lungs. Jist prescribed 5 day course of prednisone. Said neuralgia shingles and fatigue malaise. No fever. Blood pressure was 146/69. Pulse 90 at time of ER visit. Normal BP for me is 70-80/60 approx. Said to take Ibuprofen on schedule to keep in system and help with inflammation. CBC done on Fri 4/17 , showed normal values, same with PTT PT. I am to followup with primary Dr on Tuesday. Still in a lot of discomfort, neuralgia I assume. Hoping meds start working to help. Not going into work tomorrow per doc recommendation.
42 2021-04-17 discomfort lump in throat/numbness to tongue, redness to face, dry mouth, pressure under eyes, evaluated by EMS... Read more
lump in throat/numbness to tongue, redness to face, dry mouth, pressure under eyes, evaluated by EMS, symptoms improved, pt. refused transport.
42 2021-04-17 facial paralysis, numbness and pain in extremities Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly ... Read more
Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly started a couple weeks after the vaccine and eventually worsened to the point of not being able to open my mouth. Symptoms included facial paralysis, Muscle weakness, fatigue, vision issues, Neuropathy issues. I was transfused with multiple doses of Immunoglobulin and IV steroids. Still currently in Physical therapy I have lost 3 months of not being able to work. Also had a blood clot
42 2021-04-17 migraine Migraine; runny nose; This is a spontaneous report from a contactable consumer (patient). A 42-years... Read more
Migraine; runny nose; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received first dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 09:45 at SINGLE DOSE for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. Concomitant medication received within 2 weeks of vaccination included naproxen sodium (ALEVE). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Migraine and runny nose on 01Apr2021 13:00. The outcome was recovering. The patient received Immitrex as treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-04-17 myelitis transverse Acute transverse myelitis; This is a spontaneous report from a contactable physician (patient). A 42... Read more
Acute transverse myelitis; This is a spontaneous report from a contactable physician (patient). A 42-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Deltoid Left on 18Mar2021 10:30 (Lot Number: Unknown) as single dose (at the age of 42-years-old) for covid-19 immunisation. Medical history included covid-19 (prior to vaccination, the patient was diagnosed with COVID-19). Patient had no allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the vaccination. Patient previously received influenza vaccine (INFLUENZA VACCINE) on unknown date for immunisation and experienced vertigo (Vertigo from flu vaccine). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient experienced acute transverse myelitis on 26Mar2021 19:45. Event resulted in Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization) and Disability or permanent damage. Patient was treated with Prednisone. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) positive on 07Jan2021 and negative on 21Jan2021. It was reported that since the vaccination, the patient has been tested for COVID-19, date and results unknown. Therapeutic measures were taken as a result of acute transverse myelitis. Patient had not recovered from the event, at the time of the report. Information about batch/lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
42 2021-04-17 pain in extremity, numbness Severe pain in my left shoulder and arm. I received the vaccination at 5:30 pm. At 2:00 am I woke u... Read more
Severe pain in my left shoulder and arm. I received the vaccination at 5:30 pm. At 2:00 am I woke up with severe, throbbing, searing pain into my shoulder joint and surrounding muscles and numbness and tingling down my arm to fingers. I gave birth to two children with zero pain medication and can tolerate high levels of pain, but this shoulder pain brought me to tears. It?s 48 hours after the vaccination and I?m still in severe pain, the use and range of motion of my shoulder is extremely limited.
42 2021-04-17 tingling, discomfort, tremor, nerve pain, weakness, burning sensation April 12th started having severe itching, burning, tingling on left flank area. Days prior have had... Read more
April 12th started having severe itching, burning, tingling on left flank area. Days prior have had headaches that would not go away and always come back. By later on the 12th, skin started to be red. Was able to get into see Dr next morning on 13th. Dr. prescribed Valacyclovir 7 day course to take as shingles was diagnosed. Had red rash area but wasn't raised. Itching , burning, tingling still. Within a few more days, more red purple, no blisters formed. Bruising also near the red area and also on back up flank somewhat. Bruising was greenish yellow. Skin sore and sensitive to touch as well. Also spine, mid thoracic upper thoracic spine pain discomfort and also chest feeling weird and heavy, inflammed chest had felt weird too along with the pain in back, deep spine pain discomfort. Feeling of shortness of breath or something. Hard to explain. Pain and discomfort would not let up, constant in spine. Decided to go to ER today, Sunday April 18th. ER prescribed Prednisone for 5 days to take to help with inflammation and said to continue Ibuprofen regularly to help. No xray of chest or additional testing was done in ER. ER doc said neuralgia due to shingles prob causing spine pain discomfort and such. Said to take a day off work to rest and followup with my primary by tuesday. Headaches also during the week, feeling weak, run down, shaky at times. Worse in evening many days.
42 2021-04-17 tingling, numbness Pt c/o metallic taste in mouth with numbness and tingling in the lower jaw and at finger tips accomp... Read more
Pt c/o metallic taste in mouth with numbness and tingling in the lower jaw and at finger tips accompanied with dizziness.
42 2021-04-17 seizure Fever of 103.1, seizures needing 911 to be called by my child and a trip to the ED, and entire body ... Read more
Fever of 103.1, seizures needing 911 to be called by my child and a trip to the ED, and entire body aches. The fever started within the hours after the injection and lasted through the night and and my child found me seizing the next morning.
42 2021-04-17 tremor Fevers up to 102.6°F the night and day after receiving second shot. Severe chills that caused my bo... Read more
Fevers up to 102.6°F the night and day after receiving second shot. Severe chills that caused my body to shake so badly I spilled drinks. Lasted about 40 hours. Improved with Tylenol and Advil alternating every 3-4 hours but returned as soon as medication wore off.
42 2021-04-18 weakness, flushing At 11:47 am (12 min. after receiving vaccination), I started to feel faint, dizzy and very, very wea... Read more
At 11:47 am (12 min. after receiving vaccination), I started to feel faint, dizzy and very, very weak like I was going to pass out, heart beat rapidly, started to get flush and sweaty, hard to talk because my tongue and cheeks started to swell. We had just been waved through the exit, so husband pulled car over for another 30 min. to see if I got worse. Then went home. Arrived home at 1:30 pm and was hit with the same symptoms. Felt very, very weak like I was going to faint until about 3:30/4 pm. Then I started to feel more normal again. At midnight, I started to feel very weak again. Have not experienced any further symptoms since then.
42 2021-04-18 weakness, pain in extremity I received my Pfizer (1st shot) 4/12/21 @10:30 Am Later that evening around 8 PM I had a sore left ... Read more
I received my Pfizer (1st shot) 4/12/21 @10:30 Am Later that evening around 8 PM I had a sore left arm felt weak stayed that way of filling week that whole week. But I did notice that I cannot smell and still cannot as of today?s date 4- 19 -2021. I lost my sense of smell and taste but I can taste very little the flavor of any food. And I cannot smell. I was advised to report.
42 2021-04-18 cold sweat Extreme physical pain entire body, Enlarged lymph node under arm on side of injection, Blurry vision... Read more
Extreme physical pain entire body, Enlarged lymph node under arm on side of injection, Blurry vision, Intermittent fever/cold sweat.
42 2021-04-18 feeling cold, tremor Body Tremors/tremors get worse when I feel cold; dizziness; headaches; balance issue; tremors get wo... Read more
Body Tremors/tremors get worse when I feel cold; dizziness; headaches; balance issue; tremors get worse when I feel cold; I blurt out words for no reason; Eyes can't focus, when trying to read the words seem to be shaking; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm right on 11Jan2021 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 21Dec2020 (lot number: EH9899) for covid-19 immunisation. The patient experienced body tremors, dizziness, headaches, balance issue, tremors get worse when she feel cold, she blurt out words for no reason, eyes can't focus, when trying to read the words seem to be shaking on 18Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Dec2020, sars-cov-2 test: negative on 27Feb2021. There were no treatment received for the events. The patient did not recover from the events.; Sender's Comments: Based on the available information, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-04-18 pain in extremity, numbness Long lasting right arm and shoulder pain. Pain while moving arm, weakness in arm, numbness in arm. C... Read more
Long lasting right arm and shoulder pain. Pain while moving arm, weakness in arm, numbness in arm. Constant pain when arm is not in motion. Arm feels heavy and weighted down. Cannot reach backwards, upward, bend or turn arm without tremendous pain.
42 2021-04-18 tremor Immediately after injection i became nauseous followed by dry heaving, head fog, and aggressive cors... Read more
Immediately after injection i became nauseous followed by dry heaving, head fog, and aggressive corse tremors
42 2021-04-19 feeling cold, feeling hot The next morning my eyes were sensitive to light and then I became more exhausted by the hour. Full ... Read more
The next morning my eyes were sensitive to light and then I became more exhausted by the hour. Full body Aches set in, foggy head, headache. By around two I began running a light fever. By about 3 pm I felt overall horrible. By four-five I became incredibly nauseated and began vomiting about an hour later. I kept vomiting throughout the night until it was only acidic bile left. During this time I was burning up if I had even a sheet on my skin, but freezing if I didn?t. I was sweating late into the night. Vomiting stopped around 3 am. The next two days I managed rice, bananas and teaspoons of water but was always nauseated. Fever was gone, but headache and exhaustion remained. Daily nausea finally began to wane and was replaced by heartburn and gross feeling in my throat for about two days. About a week and half after the shot I finally regained my energy and had no stomach issues. Two weeks after injection today- The injection site still is bruised and burns/itches from time to time lightly.
42 2021-04-19 feeling cold, sensory loss Loss of sensation in fingers tips, chills, body aches, chest tightness
42 2021-04-19 numbness Pt. stated, "I starting feeling tingling on throat and numbness on right arm 15 minutes after gettin... Read more
Pt. stated, "I starting feeling tingling on throat and numbness on right arm 15 minutes after getting vaccinated." Vital signs taken: B/P 109/65, HR 104, O2Sat 97%, R 18. At 10:36am pt. reported feeling better, numbness and tingling is going away. At 10:38am pt. went home with husband.
42 2021-04-19 pain in extremity Day 2: Arm pain, skin sensitive around injection site, swelling, redness. Day 3: more swelling at in... Read more
Day 2: Arm pain, skin sensitive around injection site, swelling, redness. Day 3: more swelling at injection site, hard lump formed, redness spread, tiredness. Day 4: swelling decreased but lump stayed, headache with no relief after taking Tylenol, itchy at injection, run down feeling, tired. Day 5: itchy at injection and lump still there.
42 2021-04-20 feeling hot, discomfort I am reporting that I nearly fainted early in the morning. I woke up feeling uncomfortable and hot a... Read more
I am reporting that I nearly fainted early in the morning. I woke up feeling uncomfortable and hot and went to the kitchen for an ibuprofen. I immediately felt wobbly and nauseous. I sat on the floor a minute in the kitchen. Took the ibuprofen and walked back upstairs to my bedroom. Again I felt nauseous and then felt my face get hot, lips tingle, vision get grey, realized I was about to faint and lied down on the floor. A minute later I went back to bed feeling the chills, slept two hours and felt fine when I got up. Checked my Blood Pressure and it was normal. I don't normally faint. It was unexpected.
42 2021-04-20 numbness, tremor, tingling Vaccine administered 3/30/21. On 4/1/21, rash developed on buttocks right of tailbone. Feelings of f... Read more
Vaccine administered 3/30/21. On 4/1/21, rash developed on buttocks right of tailbone. Feelings of fatigue, generally unwell. Originally misdiagnosed as HSV-2 outbreak on 4/3/21. Prescribed Acyclovir. Neurological issues including numbness and tingling in legs, buttocks, and arms/hands, as well as continued fatigue/feeling unwell. On 4/12/21 discontinued acyclovir, and on 4/13/21 developed diarrhea, insomnia, agitation, stomach cramping, and tremors/shaking in legs, back, and shoulders. Visit to emergency room on 4/16/21 for diarrhea and shaking. Administered 1 L fluids; various test performed including chest XRay, EKG, and blood labs. All looked normal. On 4/16/21 follow up visit with Primary Care Provider diagnosed with shingles. Restarted acyclovir on 4/14/21 and instructed to continue by PCP. As of 4/21/21 symptoms have improved on acyclovir, but not resolved. Continued tingling in backs of legs. Fatigue and feeling unwell continues.
42 2021-04-20 migraine life stopping migraine; tighten muscles around the back of my neck and shoulder muscles; VERY nausea... Read more
life stopping migraine; tighten muscles around the back of my neck and shoulder muscles; VERY nauseated; small fever; be cold; chills; soaked in sweat; This is a spontaneous report from a contactable consumer(patient). A 42-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 13Mar2021 (Batch/Lot Number: F(E)N6208) as SINGLE DOSE for covid-19 immunisation. The patient was not pregnant. Medical history included Stroke, anorexia, gastroparesis, asthma, thyroid, low BP, hypotension, known allergies -Sulfa, Paxil, Demerol. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 09Feb2021 10:30 AM (Batch/Lot Number: EM9809 as SINGLE DOSE for covid-19 immunisation. Concomitant medications received within 2 weeks of vaccination included Fentanyl patch, seroquel, trazodone, ambien, baclofen. The patient previously took paxil and experienced known allergies-sulfa, demerol and experienced known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 14Mar2021 at 04:00, the patient experienced life stopping migraine, tighten muscles around the back of my neck and shoulder muscles, very nauseated, small fever, be cold, chills, soaked in sweat. The patient did not receive any treatment for the events. Outcome of all the events was recovered with sequelae. Information on Lot/Batch number was available. Additional information has been requested.
42 2021-04-22 numbness, slurring, tingling, facial paralysis Patient received 1st Pfizer vaccine at 3:10pm on 4/20/21 and felt only numbness/tingling in arm with... Read more
Patient received 1st Pfizer vaccine at 3:10pm on 4/20/21 and felt only numbness/tingling in arm within the first hour, then felt fine rest of day into the following day 4/21/21, until about 2:00pm when she developed a headache that got worse with time. Headache turned into pain that radiated to her ears, jaw, and neck. When patient got home close to 6pm that evening (4/21/21), she looked in the mirror and noted her face looked droopy. She went to go speak to her husband, who realized immediately that her speech was slurred. He took her to hospital where she was admitted for observation and tests were run.
42 2021-04-22 pain in extremity Headache, sore arm, rash over entire neck and upper back
42 2021-04-23 bell's palsy, facial paralysis Headache started 4 days later. Treated with Tylenol same as after the shot. Woke up today with left-... Read more
Headache started 4 days later. Treated with Tylenol same as after the shot. Woke up today with left-side facial paralysis. The ER diagnosed me with Bell's palsy.
42 2021-04-23 burning sensation, tingling itched; burned; tingled; This is a spontaneous report from a contactable Other HCP. A 42-years-old f... Read more
itched; burned; tingled; This is a spontaneous report from a contactable Other HCP. A 42-years-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El0142, Expiration date:unknown), via an intramuscular in Right arm on 04Jan2021 07:30 as SINGLE DOSE and second dose received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261, Expiration date: unknown), via an unspecified route of administration in Right arm on 21Jan2021 at SINGLE DOSE for COVID-19 immunization. Patient medical history included known allergies: Sulfa, penicillin. Concomitant medication included Vitamin C (ascorbic acid), ZINC (zinc), ADVIL (ibuprofen). 10 days after the first dose, patient's toes started itching so bad. On 14Jan2021 07:00, patient experienced itched, burned, and tingled. For 10 days feet itched, burned, tingled. Patient did not received treatment for the events. Post to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of event was recovered.
42 2021-04-24 weakness Aggressive vomiting, diarrea, weakness, shortness of breath, chills, over sweating and feeling fai... Read more
Aggressive vomiting, diarrea, weakness, shortness of breath, chills, over sweating and feeling faint 15hrs after vaccination. 911 came. Low Blood pressure 89/57
42 2021-04-24 cold sweat, numbness Nausea and cold sweats, unable to catch my breath - panting like running a marathon. Then sudden ons... Read more
Nausea and cold sweats, unable to catch my breath - panting like running a marathon. Then sudden onset total numbness in arms and legs and uncontrollable muscle contraction in my hands - I couldn?t move my hands and they clenched into tight fists on their own. Total time for event around 10 minutes.
42 2021-04-24 feeling of body temperature change, pain in extremity Fever of 102; chills; temperature swings hot/cold; sweating; Exhaustion; no appetite; entire arm ext... Read more
Fever of 102; chills; temperature swings hot/cold; sweating; Exhaustion; no appetite; entire arm extremely sore; This is a spontaneous report from a contactable consumer (patient). A 42-Year-old female patient received received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 05Apr2021 at 13:30 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 15Mar2021at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 06Apr2021 at 11:30 AM, the patient experienced fever of 102, chills, temperature swings hot/cold, sweating, Exhaustion, no appetite, entire arm extremely sore. No treatment was received. The outcome of the events was recovered. Information on the lot/batch number has been requested.
42 2021-04-24 grand mal seizure Patient received 1st dose of Pfizer Covid vaccine on 4/21, and on 4/22 had 2 generalized tonic cloni... Read more
Patient received 1st dose of Pfizer Covid vaccine on 4/21, and on 4/22 had 2 generalized tonic clonic seizures. No previous seizure history prior to this event. Workup for etiology of Seizure was unremarkable (MRI Brain, CSF studies, UA/CXR)
42 2021-04-24 night sweats, pain in extremity Myself: sore arm, night sweats, headache. Next day some body aches and chills. My 2.5 month old: 2... Read more
Myself: sore arm, night sweats, headache. Next day some body aches and chills. My 2.5 month old: 2nd dose irritable and horrible time with bowl movements. In a lot of pain as a result.. diarrhea. Lasted about two-three days. First shot bowl movements turned green for a week with an extreme sulfur line odor.
42 2021-04-24 tingling Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a de... Read more
Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.
42 2021-04-25 burning sensation Patient calling RN triage line. Patient reports receiving Pfizer COVI19 vaccine at hospital on 4/20.... Read more
Patient calling RN triage line. Patient reports receiving Pfizer COVI19 vaccine at hospital on 4/20. Patient reports onset of widespread rash directly after vaccine on face, beck, chest, and back of hands. She denies SOB, tongue swelling, difficulty breathing or airway involvement. She notes that she had a severe reactions to CT contrast in the past, and had similar widespread rash symptoms that required IV benadryl to treat. Today, 4/26, she still confirms widespread rash with increased itching and burning. She also reports severe body aches, particularly right sided flank pain. Per protocol, RN advised immediate evaluation in ED. Patient will leave now, and go to hospital.
42 2021-04-25 feeling hot Radiating heat all over body. Sweats with 99.8 fever. horrible pain in all joints especially back.... Read more
Radiating heat all over body. Sweats with 99.8 fever. horrible pain in all joints especially back. extreme thirst. brown urine. head ache. All began around 2am on Saturday and the most severe lasted until approximately 7am. From 7am to 8pm was able to start advil and tylenol rotation which helped stop the joint pain and the radiating heat. the sweats continued along with the thirst.
42 2021-04-25 flushing Patient received first Pfizer vaccination at 0800, and 10 minutes later began to experience facial f... Read more
Patient received first Pfizer vaccination at 0800, and 10 minutes later began to experience facial flushing and a scratchy throat. Her BP was moderately increased, and no swelling or evidence of narrowed airways was found upon assessment. She was kept for increased monitoring for 45 minutes, during which time she reported that she felt dizziness as well. BP went down to normal levels, and this patient reported feeling much better after 30 minutes. She was instructed to call EMS with any signs of anaphylaxis and to talk to her provider before getting her 2nd dose.
42 2021-04-25 pain in extremity 1 week after injection I developed superficial blood clots in my Left Calf, that still have not reso... Read more
1 week after injection I developed superficial blood clots in my Left Calf, that still have not resolved. Left arm and shoulder pain and headaches.
42 2021-04-25 tingling Pt received vaccine at 1305, Pt awaiting husband in post vac area when she began feeling "dizzy" and... Read more
Pt received vaccine at 1305, Pt awaiting husband in post vac area when she began feeling "dizzy" and "lightheaded". Pt state she was discharged from hospital approx 1 week ago for seizures. Patient encouraged to take slow deep breaths in through her nose and out of her mouth. Pt states relief of symptoms approx 1335. Husband at patient side. 1350 patient complains of "tingling". 1400 resolution of symptoms. Pt denied symptoms and further treatment at this time. Husband will drive patient home. Pt educated in the event symptoms should return to call 911 and to follow up with PCP as a standard to todays symptoms and complaints. Pt and husband verbalized understanding. 1325 - HR 87 BP 119/82 o2 98% 1355- HR 83 BP 135/79 o2 97%
42 2021-04-25 tingling approximately 30 minutes following administration of vaccination (at the time I was released from ob... Read more
approximately 30 minutes following administration of vaccination (at the time I was released from observation), I began feeling a tingling sensation in my face as well as itching at my temples, corner of eye, nostrils, and behind and inside my ears. I have previously experienced similar sensations after receiving immunotherapy allergy shots (and received epinephrine following those reactions).
42 2021-04-25 tingling 42 yo F p/f side effects from COVID vaccine - received Pfizer on 4/8/2021. 30 mins after vaccine not... Read more
42 yo F p/f side effects from COVID vaccine - received Pfizer on 4/8/2021. 30 mins after vaccine noted bilateral tingling on cheeks and cheeks "felt tight". This persisted for 24 hrs. She felt fine 4/10-4/11 but then on 4/12 tingling resumed and spread to posterior left scalp so she was advised to come in for visit for evaluation. Received Pfizer vaccine on R arm. Today she continues to have tingling sensation, "pins and needles, feels like right before your foot falls asleep", still bilateral. No vision changes, focal motor weakness, dysarthria or difficulty speaking, balance issues, dizziness, headache. No rash noted. No chest pain, dyspnea, palpitations.
42 2021-04-25 tingling 17 hours after first dose of Pfizer vaccine I experienced a fast heartbeat, vomitting, chills , swea... Read more
17 hours after first dose of Pfizer vaccine I experienced a fast heartbeat, vomitting, chills , sweats. Both of my arms went numb and I was unable to move my hands for about 3 minutes.
42 2021-04-25 tension headache, facial pain Shoulder pain at sight of injection at first - then spread to entire shoulder joint. Pain started n... Read more
Shoulder pain at sight of injection at first - then spread to entire shoulder joint. Pain started night of injection and caused limited mobility as well. This was very intense for the first four days. After that, it started to improve - day by day- for the next six days or so. However, at that point (about 10 days post injection) the pain in the shoulder started increasing - day by day- and now is very painful again. Ice the first day, then switched to heat after that. Not much improvement or relief. Also took Tylenol but it barely helps at all. The intensity of the shoulder pain is causing related pain in my neck and jaw because I find myself clenching my teeth in pain - which causes jaw/face pain and now headaches. They are tension type headaches because of the grinding/clenching.
42 2021-04-26 burning sensation, tingling, cold extremities Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, we... Read more
Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, went away after about 4 days, then came back around day 12 with chills and feeling run down/sick, but as more of a pins and needles/cold burn feeling, again mostly around legs, went away after a few days, came back again 4/26 as pins and needles and cold burning feeling with chills every now then, also experiencing off and on vertigo since vaccine and tinnitus, as well as painful lymph nodes in chest mostly on vaccine side starting in day 12ish post vaccine.
42 2021-04-26 hot flush 10 minutes following vaccination, pt reported feeling "heart racing" and hot flashes. Pt was moved t... Read more
10 minutes following vaccination, pt reported feeling "heart racing" and hot flashes. Pt was moved to cot to lay down and was offered fluids. at 1pm, client reported improved symptoms but continued fatigue.
42 2021-04-26 numbness, tingling, cold sweat Cold sweats, heart palpitations, racing heat, chest pain, shortness of breath, numbness and tingling... Read more
Cold sweats, heart palpitations, racing heat, chest pain, shortness of breath, numbness and tingling in extremities, head ache, light headedness, joint and muscle pain, diarrhea, and pain at injection site.
42 2021-04-26 muscle spasms, burning sensation, hypersensitivity of all senses, feeling hot - Around 5pm joint pain in legs, shortly after I also felt back pain...joint pain lasted for about 3... Read more
- Around 5pm joint pain in legs, shortly after I also felt back pain...joint pain lasted for about 30 hours but was eased with Tylenol and Ibuprofen on 4/23 - same day around 9:30pm I started to feel the chills, afterwards felt very hot, this was gone the next morning but started again the next night (4/23) around 7pm - morning of 4/23 strong dull headache on left side/front of head...1000mg of Tylenol did not help, took another 800mg of Ibuprofen 3 hrs later which eased the pain - my skin felt very sensitive to the touch for about 48 hours (like a burning sensation) - felt very light headed for stretches as of morning of 4/23 until evening/going to bed on 4/24 - pain and swollen lymph nodes under left armpit (started the night of 4/22 and lasted until 4/25) - felt dizzy from time to time...did last for a couple of hours each day - muscle ache in both arms and tummy started 4/27 in the afternoon ( haven't done any sport) - jaw muscle ache left side when opening mouth (started 4/26 in the evening) - cramps in my feet (started first 4/25 in the afternoon and have it at least twice daily since then)
42 2021-04-26 nerve pain, muscle spasms The night of 4/7 I began to have a very bad acid stomach and started throwing up. I stopped throwing... Read more
The night of 4/7 I began to have a very bad acid stomach and started throwing up. I stopped throwing up on 4/8. I continue to have acid reflux presently. On 4/12 I began to have extreme pain in my neck and upper back which persisted for a couple of weeks. On 4/20 I began to have increasing burning pain in my upper left back in one spot that felt different than the muscle pain in my neck and upper back. On 4/24 I woke up to all the muscles in my back seized up and spasms in my neck and upper back constantly. On the morning of 4/25, I developed a rash from the spot on my left upper back that had been burning in the nerve. The rash is raised, red and has yellow pustules. It stretches across from my left upper back and wraps around my trunk and across my left breast. The nerve and muscle pain in my upper back was extreme. On the afternoon of 4/24 I went to Lifespan Urgent Care and was diagnosed with Shingles and prescribed Valtrex. I have been on the medication for 3 days and the rash has spread but seems like it is starting to heal. The extreme pain in my back and neck muscles has started to subside but is still very painful. I am not able to get in to see my Physiatrist who treats my usual back pain until May 13.
42 2021-04-27 weakness Day 1 of symptoms (April 5) stomach ache and pains April 6 stomach pains constant and sometimes sha... Read more
Day 1 of symptoms (April 5) stomach ache and pains April 6 stomach pains constant and sometimes sharp, mild flu symptoms April 7 severe stomach pain, flu symptoms. Took rapid covid test which came back negative. In the afternoon temp hit 104 and I went To ER. After CT scan, appendicitis was confirmed and went into emergency surgery. Appendix ruptured. April 9 - released from hospital as of 4/28 most symptoms are gone but BM are not consistent and stool is soft. Energy level is low. Slight lower stomach pain at times and muscle soreness
42 2021-04-27 numbness swelling of face, facial numbness
42 2021-04-27 numbness Pointer finger on left hand is numb. It started about 1 hour after the injection and has not changed... Read more
Pointer finger on left hand is numb. It started about 1 hour after the injection and has not changed.
42 2021-04-27 muscle spasms Heavy Periods two and half weeks apart. 1st one was very heavy and second one has been five days of ... Read more
Heavy Periods two and half weeks apart. 1st one was very heavy and second one has been five days of painful cramping so far. Very unusual for my cycle. Also had flu like symptoms the day after my second shot for about 24 hours, but I was expecting that. I was not expecting issues with menstruation. I have heard antidotal stories from other women that they experienced heavy and painful menstruation after the shot. Women really should be told this is a side effect if it is so they don't think something is "wrong" and so that they can be prepared.
42 2021-04-27 numbness and pain in extremities, numbness, tingling neuropathy in her left foot/ numb like tingling, a lot of tingling feeling/feel it every now and the... Read more
neuropathy in her left foot/ numb like tingling, a lot of tingling feeling/feel it every now and then throughout her body; numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body; numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body; felt weird; Iinterfering with her brain; makes her "like I want to cry."; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 01Apr2021 (lot number: ER8737) as single dose (at the age of 42-years-old) for COVID-19 immunisation. Medical history included temporomandibular joint syndrome (TMJ), headache and clench my teeth; from an unknown date and unknown if ongoing. Concomitant medication included butalbital, caffeine, paracetamol (BUTALBITAL, ACETAMINOPHEN & CAFFEINE) taken for "clench my teeth", start and stop date were not reported; the patient was also taking unspecified vitamins, supplements and an unspecified headache medication. The patient received the first shot of BNT162B2 for Covid-19 immunisation on an unspecified date. The patient had both the shots and was wondering because she was left with like this neuropathy in her left foot, it was kind of numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body. It was like setting on her left foot and she got the shot on her left side. She got the last second shot and got it on Thursday (01Apr2021). She told her doctor right away the she saw this only after the last shot. She told the guy it was weird, it felt weird and then he said, you know it was a kind off to the side and was just "mental". But it has not gone away, it was like neuropathy, she doesn't remember if it was with the first shot because it was so quick in between. She wanted this to go away, it was really annoying. It was interfering with her brain, it was not good, it makes her "like I want to cry." The patient had a lab work done on Thursday morning (08Apr2021) and stated that her blood work was fine. They did a thyroid check, did her blood sugar and everything was fine; and her B12 to make sure her B12 wasn't low but everything was fine. The patient does not know the name of the tests. The patient wanted to know if the side effects she was experiencing was normal and was it going away. The outcome of the events was unknown.
42 2021-04-27 night sweats Night sweats for 3 nights so far; cystic pain and fever for 24 hrs.
42 2021-04-27 pain in extremity, feeling hot Hot, fever, arm pain to the extent I couldn?t use my arm normally, sore throat, very swollen and sor... Read more
Hot, fever, arm pain to the extent I couldn?t use my arm normally, sore throat, very swollen and sore lymph nodes in neck and groin, achy, tired, no appetite
42 2021-04-27 throat numbness, tingling At about 2:30 started feeling funny. Thought I was possibly hypoglycemic but my blood sugars were 12... Read more
At about 2:30 started feeling funny. Thought I was possibly hypoglycemic but my blood sugars were 123. Then about 3:00 tasted feeling tingling in my arm and finger tips and legs. 3:30 my legs felt like they were swollen but the weren't. Noticed I was coughing more to clear my throat. And felt a little itchy on different parts of my body. Around 4:30 my husband noticed I had something on my face. Turned out to be hives. My throat area velt wierd a little numb but not completely. I felt big lumps on both sides of my neck. I then started to feel tingling on my nose and left side of my tongue. I noticed it felt a little uncomfortable to swallow almost like a sore throat but without pain. I did not feel short of breath at any time. I took 50mg of benadryl at 6pm. The symptoms started to subside. Still had occasional itching. By the morning I felt better. Throat felt better and itching was gone. I did end up taking more benadryl at about 8pm because I noticed my throat feeling swollen again. By the morning I was back to normal again.
42 2021-04-28 inability to speak At about 3:50 PM client was given vaccine. 10 min or so later reported lips feeling fuzzy. No troubl... Read more
At about 3:50 PM client was given vaccine. 10 min or so later reported lips feeling fuzzy. No trouble with breathing. At 1610 B/P 130/94 P 80. At 4:16 PM 911 was called. About 4:20 PM client reported something is happening to me. Client brought up both hands to head & stated feeling pressure behind both ears & in both ears. Pulse not racing. 2nd nurse speaking with client to support, calm, said she was having trouble finding words. EMS assessed & had client walk with them to the ambulance. RN
42 2021-04-28 breast pain Stiff muscle in neck and shoulder on left side. Next day had a fever and body aches. Pain in left si... Read more
Stiff muscle in neck and shoulder on left side. Next day had a fever and body aches. Pain in left side under arm pit. When I use the arm to much I have pain go in my left Brest.
42 2021-04-28 flushing After 30 minutes receiving the vaccine pt felt itching of the tongue, feeling flushed & itching of b... Read more
After 30 minutes receiving the vaccine pt felt itching of the tongue, feeling flushed & itching of both cheeks, after an hour, slight difficulty swallowing & talking, tongue felt thick & funny, also itching of whole body no rashes, Took liquid Benadryl & Liquid Zyrtec per instructions of immunologist with some relief.
42 2021-04-28 muscle twitching It started with hand twitching the same week I got the Pfizer shot which I assumed was unrelated. Th... Read more
It started with hand twitching the same week I got the Pfizer shot which I assumed was unrelated. Then on 4/17 I noticed an internal vibration sensation. This internal vibration sensation persisted and became more frequent (chest, lower half of head predominantly but sometimes whole body as well). April 23 to 25 was happening a lot even while sleeping. On April 23 I went to Urgent care for unexplained high blood pressure, ran tests, and was released. Consulted doctor on April 26 about high blood presure and internal vibration sensation (unclear if related) and ran more tests. Still unclear cause. Will see if symptoms continue to improve.
42 2021-04-28 night sweats, tremor, pain in extremity Shot given at 11AM by 6pm chills and shakes began, headache, fever coming on, sore arm, ache in body... Read more
Shot given at 11AM by 6pm chills and shakes began, headache, fever coming on, sore arm, ache in body, nausea, puking, fever of 102, Advil taken at 10PM to help with fever, keytones present, elevated heart rate, insulin resistant, in the emergency room by 4:45AM, given 3 pages of fluids, including magnesium, heart rate as high at 156, chest x-ray and ekg taken. By 2:45pm, stabilized and released home, that night - night sweats, fever broke, and keytones finally released. Every side effected reported, I had after my second shot and it sent my diabetes spiraling into what appeared to be DKA, but luckily I was diligent and went to the ER and was able to get some help.
42 2021-04-28 pain in extremity SKIN CHANGES ON BILATERAL UPPER ARMS AND CHEST. LIGHTENING OF SKIN IN CIRCLES. FEVER,SORE ARM,MUSCL... Read more
SKIN CHANGES ON BILATERAL UPPER ARMS AND CHEST. LIGHTENING OF SKIN IN CIRCLES. FEVER,SORE ARM,MUSCLE ACHES
42 2021-04-28 pain in extremity Awful achiness, toes, fingers everything hurts . Swollen knot or lymph node under my right arm., ti... Read more
Awful achiness, toes, fingers everything hurts . Swollen knot or lymph node under my right arm., tired, ans woke up with cold sores in my mouth
42 2021-04-29 bell's palsy I came down with shingles and then bell's palsy
42 2021-04-29 feeling cold Pfizer-BioNTech COVID-19 Vaccine EUA. Bad headache, fever of 100.7, chills, nausea, fatigue, inject... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Bad headache, fever of 100.7, chills, nausea, fatigue, injection site pain. Headache started approx. 12 hours after injection of second shot. Fever, chills and nausea began approx. 24 hours after receiving shot. Symptoms lasted approx. 24 hours. Received 2nd shot Wednesday at 5:30 pm, Thursday around 7:00 am woke up with bad headache. Symptoms continued throughout day getting worse around 5:00 pm. Friday morning around 7:00 am woke to find symptoms were mostly gone.
42 2021-04-29 numbness On the afternoon of 4/29/2021 at 2pm, patient came to the pharmacy after receiving her second Pfizer... Read more
On the afternoon of 4/29/2021 at 2pm, patient came to the pharmacy after receiving her second Pfizer-Biontech COVID-19 vaccine on 4/27/2021 at 1pm. She spoke with pharmacist regarding side effects. She stated that on 4/27/2021 after receiving her vaccine, she woke up in the evening around 8pm feeling soreness in her arm and tingling that radiated from the injection site in the left deltoid muscle to the tips of her fingers. She told the pharmacist that on the following day 4/28/2021 at around 1pm she took some Tylenol for the pain. She noticed at that point that her arm and fingers were swollen, numb, and that she could not fully close her hand. When she appeared at the pharmacy on 4/29/2021, she stated that her ability to move her hand had returned, but that the swelling and numbness were still the same. Pharmacist observed that her arm around the injection site was warm and swollen. She advised the patient to contact her medical provider for further evaluation and in the meantime continue to use Tylenol (the patient could not use anti-inflammatory medications due to a medical condition) and apply cold compresses to the arm. She also requested the patient to contact the pharmacy for any further questions and to provide an update the following day on 4/30/2021. On 4/30/2021, pharmacist reached out to the patient at 10am to follow up. The patient stated that swelling and numbness in the hand had decreased, but the tingling sensation was still present. She is planning on following up with a medical provider today.
42 2021-04-29 migraine Fatigue, nausea, migraine, fever, chills, sweats
42 2021-04-29 pain in extremity Arm pain, swelling of the arm, shoulder, neck and a ball under the arm. Headache, sweating, itching ... Read more
Arm pain, swelling of the arm, shoulder, neck and a ball under the arm. Headache, sweating, itching all over the body and muscle aches. I feel like a lump in my throat and I feel very tired.
42 2021-04-30 difficulty speaking Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the mid... Read more
Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs; Dizziness; At the time she was given her COVID-19 Vaccine shot, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back; dry eyes; she was coughing more; the increase in coughing had made her voice huskier sounding; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 08:45 Arm Left (Lot Number: EP6955, Expiration Date: 30Jun2021) single dose for covid-19 immunisation. Medical history included ongoing Crohn's disease from 1999, ongoing Hidradenitis suppurativa at the end of 2019, ongoing Small Fiber Peripheral Neuropathy diagnosed at the end of 2019. She said her doctor was not sure of the Small Fiber Peripheral Neuropathy's cause, or if the Small Fiber Peripheral Neuropathy was associated with any of her other medical conditions. She said she had symptoms for sometime, and was diagnosed with a lot of things at the end of 2019 because she was finally able to see a specialist. Concomitant medications included adalimumab (HUMIRA AC) from in Feb2020 at 40mg injection pen once a week for her Crohn's disease. Reported she has had no reactions to flu or pneumonia vaccines for immunisation in the past. She said she had her first COVID-19 Vaccine dose on Thursday, 18Mar2021. She said on Saturday morning (20Mar2021), she had shortness of breath, dizziness, and chest pressure. She said her shortness of breath, dizziness, and chest pressure has been lasting for 20-something days, and she doesn't know why. She said she had taken two (different) week long prescriptions of Prednisone. She said she had 2 EKGs, 2 chest x-rays, and blood work, which were all normal on 13Apr2021 and 2021. She said her doctors don't know why she was having the shortness of breath, dizziness, and chest pressure. She said she was using inhalers, medications, and everything, and still had her symptoms. She asked if what she was experiencing was a side effect of the COVID-19 Vaccine, or due to her 2 autoimmune diseases because her doctors were grasping at straws at this point. Reported she had so many medical conditions, and was taking so many different medications. Reported she has had shortness of breath and chest pressure every day, but the dizziness wasn't constant, and had lessened. She said she has never had the shortness of breath and chest pressure before. She said she has never had anything last that long either. She said she was wondering if her shortness of breath and chest pressure were caused by the COVID-19 Vaccine. Clarified the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, saying it was an odd feeling. Reported she was coughing more, and she believed the increase in coughing had made her voice huskier sounding in 2021. She said she had a cough associated with outdoor allergies, but the cough she had now didn't feel like her normal allergy cough. She said she had no mucus. She said she was not sneezing, or coughing out anything. She said the cough she had now was different. Reported at the time she was given her COVID-19 Vaccine shot 18Mar2021, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her fingertips. She said the warmth feeling also went to the left side of her back. She said she was kept longer after she got her COVID-19 Vaccine for monitoring. She said the warmth feeling in her left arm, left fingertips, and left back didn't last long, and went away. Reported she had gone to the Emergency Room on Tuesday, 13Apr2021, because she had palpitations, and a weird feeling under her skin. She said while at the Emergency Room, she had an EKG, chest x-ray, and blood work. She said the doctor was looking for a blood clot. She said all her testing came back negative for a blood clot. She said earlier that day (13Apr2021) was her 3rd visit to her doctor since her symptoms had started. Reported she had started Restasis on 19Mar2021, the day after her first COVID-19 Vaccine. She said she was prescribed Restasis for dry eyes, and didn't have the dose, NDC, Lot, and Expiration Date because she was not at home. AEs require a visit to Emergency Room and Physician Office. Treatment included Stated she had taken 2 different week long doses of Prednisone to treat her symptoms. She said she first took Prednisone 40mg, once a day, for 7 days. She said she was off the Prednisone 40mg for 2 days, and had instructions to call her doctor if she wasn't feeling better. She said she went back to her doctor, and was prescribed Prednisone 60mg for 3 days, then Prednisone 40mg for 3 days, and then Prednisone 20mg for 3 days. She said she did not have the 2 Prednisone prescription NDC, Lot, and Expiration Dates. She said she was also put on a 10-day Azithromycin 250mg tablet prescription. She said she took a Azithromycin 500mg (2-250mg tablets) dose the first day, and then Azithromycin 250mg, once a day, for the next 9 days. She said she did not have the Azithromycin 250mg tablet NDC, Lot, and Expiration Date. She said she was also prescribed an Albuterol (90mcg per actuation) inhaler, providing: NDC Number: 66993-019-68, Lot Number: A63H, Expiration Date: Jan2022. She said she didn't feel like the Albuterol inhaler was doing the rescue part, and that she could take the Albuterol inhaler every half hour. Reported she was prescribed an Albuterol inhaler (90mcg per actuation) for shortness of breath. Outcome of the event Shortness of breath, the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, coughing more, the increase in coughing had made her voice huskier sounding was not recovered. Outcome of the event Palpitations, a weird feeling under her skin was unknown. Outcome of the event Dizziness was recovering. Outcome of the event had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back was recovered on 18Mar2021. No follow-up attempts are needed. No further information is expected.
42 2021-04-30 facial paralysis Patient called and reported sudden symptoms that "felt like a nerve thing" and a sudden facial droop... Read more
Patient called and reported sudden symptoms that "felt like a nerve thing" and a sudden facial drooping on one side. The symptoms subsided after a few minutes. I instructed the patient to report any additional symptoms and to seek guidance from her MD if symptoms return. We also discussed the possibility of Bell's Palsy after COVID vaccines.
42 2021-04-30 migraine with aura Woke up around 5:30am about 47 hours after vaccine with dizziness and nausea and inability to walk s... Read more
Woke up around 5:30am about 47 hours after vaccine with dizziness and nausea and inability to walk straight line. Called into my clinic to cancel first few hours of patients as I realized I could not drive safely. Went back to sleep and awoke 2 hours with a left sided frontal/temporal headache with resolution of the other symptoms. At that time, I realized I had had my first migraine with aura. I was able to take ibuprofen and drive to work. Since that vaccine, I co to to have mild short lived headaches in this area a few times/ week. I had my second covid vaccine on 3/5/21 and did not have recurrence of the migraine with aura symptoms.
42 2021-04-30 muscle twitching My initial reaction within 5 minutes after vaccine injection I was sitting in waiting/observation ro... Read more
My initial reaction within 5 minutes after vaccine injection I was sitting in waiting/observation room and had 2 major dizzy spells. Felt like I was going to faint and heart rate felt elevated. This subsided somewhat. Stayed in waiting room for 30 minutes. When I left facility heading home as someone else was driving me, I had another sudden side effect attack but much worse. The side of my mouth/chin area started to flutter and then that was followed immediately by shortness of breath, minor feeling of throat closure, very dizzy and extremely rapid heartbeat.
42 2021-04-30 pain in extremity It now goes up to her neck, her back, down her arm and her hand; It now goes up to her neck, her bac... Read more
It now goes up to her neck, her back, down her arm and her hand; It now goes up to her neck, her back, down her arm and her hand; immense pain travel down her entire left arm into her hand; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 03Apr2021 at 13:45 as a single dose for COVID-19 immunization. Medical history included migraine and unspecified known allergies both from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included topiramate (manufacturer unknown); sumatriptan (manufacturer unknown); eszopiclone (LUNESTA) and promethazine (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not have other vaccines in four weeks prior to the COVID vaccine. The patient was not tested for COVID post vaccination. On 03Apr2021, it was reported that within two minutes of receiving the injection, the patient had immense pain travel down her entire left arm into her hand. She knew it wasn't normal. The patient called the paramedics over because the pain got so intense she couldn't even touch her arm nor her hand. The paramedic said this was not a normal reaction and maybe they hit a nerve but he's not sure what's going on. It's been two weeks since her vaccine injection. The pain comes and goes just as bad as that bad. It now goes up to her neck, her back, down her arm and her hand. She can't use it nor touch it. The events result in a doctor or other healthcare professional office visit and was reported to have caused disability/permanent damage. The patient had not recovered from the events. Information about lot/batch number has been requested.
42 2021-04-30 tenderness Began with hives on hands and neck area 3 days after covid vaccine, I took benadryl before bed and ... Read more
Began with hives on hands and neck area 3 days after covid vaccine, I took benadryl before bed and woke the next morning to hives spreading to entire body. I took another dose of benadryl mid day. By evening I was in anaphylaxis with swollen lips and itchy gums. Went to the ER and received ephnephrine, intravenous benadryl, pepcid and prednisone. Was monitored for 3 hours, swelling was gone and symptoms had subsided. Went home. Next morning symptoms were less but feet were tender to walk on and hands and feet were itchy. Picked up prescrription prednisone and loratadine and took both that morning. By evening afternoon was very itchy and hives on back, legs, arms and neck took benadryl that evening which helped but currently itchy red hives on arms, hands, neck, legs and feet - all over body. A new symptom is very swollen lymph nodes in neck.
42 2021-04-30 tremor Started shaking uncontrollably; I am very sick; This is a spontaneous report from a contactable cons... Read more
Started shaking uncontrollably; I am very sick; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: ER8729; Expiration Date: 31Jul2021) (at age of 42-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 16Mar2021 (Lot number: EN6207, Expiration Date: 31Jul2021) and was okay after the first one. The patient experienced shaking uncontrollably and very sick on Apr2021. The events result in emergency room visit. The patient stated, "I am calling because I got the 2nd COVID Vaccine shot, the Pfizer one and I am very sick, I had to go to the emergency room '2' days after I got the shot. I started shaking uncontrollably and I can't stop the shaking and the hospital that I went, they just gave me a little bit of medicine (Unspecified Medication) to try to calm down my nerve but there is something really wrong with the shot and me (Clarification unknown). I need to feel better." When probed for the date when consumer went to the emergency room, consumer stated, "I was yesterday (11Apr2021) and I came yesterday (11Apr2021), so 1 day and they told me to call a neurologist." Therapeutic measures were taken as a result of shaking uncontrollably. The outcome of events was unknown. No follow-up attempts are needed. No further information are expected.
42 2021-05-01 pain in extremity, hot flush Vaccine at 10:30 am; general malaise onset around 1 pm; sore arm started around 4 pm; body aches, in... Read more
Vaccine at 10:30 am; general malaise onset around 1 pm; sore arm started around 4 pm; body aches, injection site was hot; chills/hot flashes started around 8:30 pm; insomnia; joint pain. lymph node tenderness. Symptoms were mild - medium (not severe). Mostly uncomfortable. 24 hours lymph node under injection arm swollen - and as of now it still is. the only remaining symptom at 7 am 5/2 is swollen armpit / lymph node on injection arm.
42 2021-05-02 numbness Female patient presents to EMS observation area post vaccine with complaint of leg numbness. Patient... Read more
Female patient presents to EMS observation area post vaccine with complaint of leg numbness. Patient reports baseline anxiety and became extremely agitated requesting transport to hospital.
42 2021-05-02 pain in extremity Nauseous all day 5/2 and 5/3 Arm very sore, could not lift over my head until 5/3 Back pain just on ... Read more
Nauseous all day 5/2 and 5/3 Arm very sore, could not lift over my head until 5/3 Back pain just on left side started the afternoon of 5/2 and continued until the afternoon of 5/3, difficult to sleep because of discomfort in the mid back to side 5/3 injection site slightly itchy started in the evening and onset of headache
42 2021-05-02 pain in extremity I received my second Pfizer/Biontech vaccine on May 1 (the first vaccine appointment was late April)... Read more
I received my second Pfizer/Biontech vaccine on May 1 (the first vaccine appointment was late April). After the 2. vaccine which I received in the morning around 9:30 am I started feeling extreme fatigue, muscle pain/soreness, strong headache, dizziness and my left arm hurt slightly (the arm where I received the injection. The same symptoms lastet the entire following day. The symptoms have been continuing today, Monday, and I had in addition temperature and felt nausea. I went to a pharmacy and got Advil for the headache as I am working which did not help much.
42 2021-05-03 numbness, pain in extremity 15 minutes after the injection my wife had slightly numb fingers on her left hand. 10 to 15 minutes... Read more
15 minutes after the injection my wife had slightly numb fingers on her left hand. 10 to 15 minutes later, her heart was racing and she nearly passed out several times over the next 30 minutes. Her left fingers and tongue went numb. Her speech was impacted. She had a very hard time to find the words to speak - similar to a stroke. She had delayed and choppy speech and complained about not being able to think of the words to say. She had some stuttering as well. We went to the ER, following the advice from the advice nurse. The ER was very full. After waiting roughly 3 hours in the ER, her speech had come back and was fairly normal. Her numbness was almost all gone as well. We never got to see a physician. Today, 05/04/5021, her symptoms are sore arm, slight fever, and lethargy.
42 2021-05-03 numbness hearing loss Left ear. tinnitus in both ears. Facial numbness (resolved now) Hearing loss left ear ... Read more
hearing loss Left ear. tinnitus in both ears. Facial numbness (resolved now) Hearing loss left ear improved. Still high pitched tone tinnitus in both ears persistent shoulder pains.
42 2021-05-03 pain in extremity, breast pain Day 1: Sore Arm Day 2: headaches, body aches, very sore arm, sharp pain through the L breast and L f... Read more
Day 1: Sore Arm Day 2: headaches, body aches, very sore arm, sharp pain through the L breast and L forearm Day 3: vaginal ulcerations-Behcets Day 5 (4/19/21): Intermitten heart pounding, vaginal ulcerations- hurts to void
42 2021-05-04 weakness, speech disorder Patient complaint of difficulty breathing, shallow breathing, feeling weak, difficulty talking after... Read more
Patient complaint of difficulty breathing, shallow breathing, feeling weak, difficulty talking after the 2nd dose of Pfizer vaccine. Pharmacist lay patient with legs elevated. Called 911 immediately. 1 dose of 0.3 ml epinephrine given on right thigh(ndc 001151694-30 lot g201101x) monitored bp and hr every 2 minutes. Vitals remain stable and paramedics arrived to release patient.
42 2021-05-04 bell's palsy Bell?s Palsy (right side of face)
42 2021-05-04 feeling hot 2 hours post-injection, I experienced an episode of nearly fainting (all over body heat, sweat, hear... Read more
2 hours post-injection, I experienced an episode of nearly fainting (all over body heat, sweat, hearing and vision lessening). I made sure my feet were planted and put my head down between my knees. After 10-15 minutes, I started to return to normal. I never fully fainted. I was sitting at home on the couch.
42 2021-05-04 feeling hot red splotches on her arm and a little on her face/Arm was very splotchy; Also got kind of hot/Face a... Read more
red splotches on her arm and a little on her face/Arm was very splotchy; Also got kind of hot/Face a little hot; anemic; she thought she was getting shorter; second period which was pretty heavy; had her period twice in a month; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533 and expiration date not provided), via an unspecified route of administration, in arm right, on an unspecified date (at the age of 42-year-old), at single dose, for COVID-19 immunization. Medical history included allergy to steroid (patient did not remember the name of the steroid. Patient was given to her to stop from pre term labor when she had her last child. when patient took it, her heart pounds, almost like cardiac arrest. Was told to never do the steroid ever again); ongoing latex allergy; and allergic reaction to soap. No prior vaccination within 4 weeks. No family medical history. Concomitant medications were not reported. The patient previously took ibuprofen (MOTRIN) for back pain (It was usually around her period or if her back was injured. Patient had injured back so many times. It was not used as an everyday thing). Patient stated her period was usually normal. And patient had her period twice in a month. Patient was started a second period which was pretty heavy, was anemic, so was a little concerned. On 18Apr2021, the patient had heavy second period. It was started last night at dinner, was very unexpected. And it was still very heavy, like in the middle of patient's period. Patient had been taking MOTRIN, which she usually took for back pain. About a half hour after the shot, patient's face a little hot. Half hour after the shot. Patient's left arm was very splotchy/ red splotches in left arm and a little on her face, also got kind of hot. Patient thought it must be from the body wash. Patient never noticed that before. Patient had allergic reaction to soap before and it was usually immediate. Is possible to be from the body wash. The splotches had gone away. It was ended the night she got home, same day as the shot. No emergency room or physician's office required. Patient's height was 5'3" and stated that she thought she was getting shorter. The outcome of the events "had her period twice in a month" was not recovered; of event "red splotches on her arm and a little on her face/Arm was very splotchy", "Also got kind of hot/Face a little hot" was recovered in 2021; of other events was unknown. No follow-up attempts are needed. No further information is expected.
42 2021-05-04 numbness Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: right arm and right... Read more
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: right arm and right leg, observered for 30 minutes with husband and went home, we called twice and symptoms went away
42 2021-05-04 pain in extremity After the first shot/vaccine on 4/12/21 I only experienced pain in my right arm for 2 days. After t... Read more
After the first shot/vaccine on 4/12/21 I only experienced pain in my right arm for 2 days. After the second shot/vaccine I had pain in my right arm. The night of the vaccine I woke up at 11:30 pm with a fever of 100.7° and muscle aches, joint pain, chills, headache and nausea. I took 2 advil and went back to bed. Then woke up at 2:30 am with all the above symptoms worse than before and a fever is 102.3°. At this point I was feeling very unwell. I took tylenol and had a full glass of Gatorade and headed back to bed. I slept very little that night. 5/4/21 I was extremely tired, still had muscle aches, arm pain and joint pain and a 100.8° fever all day. I got up at 5:30 am. Why back to bed at 8 am slept until 12 pm ate lunch. Went back to bed at 1:30 and slept until 5 pm. Got up had dinner and then went back to sleep at 9:30. Today 5/5/21 I have felt better so far. No Symptoms today.
42 2021-05-04 pain in extremity Sore upper arm from the first 24 to 36hrs. Severe (can't sit >15min; can't lie down >3hrs) lower ba... Read more
Sore upper arm from the first 24 to 36hrs. Severe (can't sit >15min; can't lie down >3hrs) lower back pain starting 6 days after the shot and still ongoing 13 days after pain started.
42 2021-05-04 tingling, numbness Six hours after receiving vaccine felt very tired. Next morning body aches, moderate headache, very... Read more
Six hours after receiving vaccine felt very tired. Next morning body aches, moderate headache, very tired and chills. Fever off and on with chills. 50 hours after vaccine felt fine and continued with normal life. One week (7 days) after vaccine experiencing chills, body tingling and arm and leg numbness. Severe headache and nausea. This has been going on for over 24 hours now.
42 2021-05-04 cold extremities Experienced chills with really cold feet and headache. Today her chills was gone but still feels lik... Read more
Experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts; Experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts; Experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts; Experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-year-old on 12Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. patient has gotten her first shot of the Pfizer Covid 19 vaccine last 12Apr2021 and on 17Apr2021, she experienced chills with really cold feet and headache. Today her chills was gone but still feels like she has a mild fever and head still hurts. Asking if this is normal and as to how many days it usually lasts. Outcome of headache and fever was not recovered, outcome of chill was recovered and outcome of cold feet was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
42 2021-05-05 difficulty speaking Pt stated she received vaccine at 1:30pm on 05/05/2021 and waited for 30 minute post vaccine as inst... Read more
Pt stated she received vaccine at 1:30pm on 05/05/2021 and waited for 30 minute post vaccine as instructed with no reaction. When she was driving on her way to pick up her child from school, her throat began itching. Call received at 2:44pm on 05/05/2021, pt stated she was having itchy throat and scratchy voice. RN instructed pt to promptly seek medical care. After picking child up from school, pt went to local fire department and was transported to ER for further treatment. Pt stated at ER, she was given steroids, benedryl, and toradol and had improvement in symptoms. Pt was discharged from ER with Epi-Pen and benedryl.
42 2021-05-05 flushing Flushing of skin. No itching or raised hives. No shortness of breath.
42 2021-05-05 night sweats Metallic taste as soon as shot was received Approx 8 hours later ringing in the ears that lasted ho... Read more
Metallic taste as soon as shot was received Approx 8 hours later ringing in the ears that lasted hours. Fever and night sweats Headache Nausea lasting 3 days
42 2021-05-05 tension headache Two hours after receiving the first doze, I started to get dizzy (the room started to spin). I conta... Read more
Two hours after receiving the first doze, I started to get dizzy (the room started to spin). I contacted the pharmacy to ask if it was a common side effect, and the pharmacist told me to lie down on my side to see if the dizziness goes away in about 30 minutes. It didn't. I contacted the office of my primary care physician, and the nurse told me that it was not a common side effect, that I should go into the urgent care or ER. I did not take myself in, as I was feeling extremely dizzy. After 8 hours from getting the shot, I started to feel better and went to sleep. I felt better the next morning; however, I continued to have on and off dizziness/vertigo for the next 10 days, to the point that I chose not to drive my children around. In addition to dizziness/vertigo, during the first 10 days, I also experienced sensitivity to sounds and a feeling of a band around my head, squeezing. From day 11 to day 14, I experienced extreme fatigue. I was out of breath and my heart was racing from doing basic activities, such as cooking, cleaning the floor, and walking from one room to another.
42 2021-05-06 weakness, pain in extremity Very bad pain and soreness in arm. As of today arms still a lil sore, both arm and legs very weak, ... Read more
Very bad pain and soreness in arm. As of today arms still a lil sore, both arm and legs very weak, lost of appetite for days, headache, drop in daily energy, menstrual cycle has been off and on since first vaccine on 4/8/2021
42 2021-05-06 cold sweat Low grade fever 95.8 for 3 days. Cold sweats and chills.. Just put extra clothes on to keep warm and... Read more
Low grade fever 95.8 for 3 days. Cold sweats and chills.. Just put extra clothes on to keep warm and attempt to bring my body temperature up.
42 2021-05-06 muscle spasms, nerve pain, numbness Severe muscle spasms in both shoulders and lower back. Nerve pain and numbness in both arms and hand... Read more
Severe muscle spasms in both shoulders and lower back. Nerve pain and numbness in both arms and hands. Nerve pain in right leg and numbness in right foot. All areas affected lasted for one week. Afterwards, conditions alternated areas until present day.
42 2021-05-06 tingling shakes, body aches, fever, pain in arm pit of the same arm vaccine was administered, neck pain, pai... Read more
shakes, body aches, fever, pain in arm pit of the same arm vaccine was administered, neck pain, pain shooting down arm with tingling in fingers (if arm vaccine was administered), pain in eyes, fatigue, headache
42 2021-05-06 tremor Patient started feeling nauseous and sweating, she was shaking and very anxious. Her glucose read 1... Read more
Patient started feeling nauseous and sweating, she was shaking and very anxious. Her glucose read 190 and her vitals: BP 120/88, HR 96. Surgery a month ago on her pancreas.
42 2021-05-06 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: pt had synco... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: pt had syncope event. pt did not pass out, but almost did. blood pressure was taken and bp was low. heart rate 84. pt recovered within 5 minutes and drank gatorade
42 2021-05-07 weakness 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, ... Read more
14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; Not sleeping at night; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; This is a spontaneous report from contactable consumer. A 41year old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8735), via an unspecified route of administration administered on Left arm at 24Apr2021 12:30 PM (at the age of 41 years) as a single dose for covid-19 immunisation. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8734), via an unspecified route of administration administered on Left arm at 03Apr2021 04:30 PM as a single dose for covid-19 immunisation. The patient's medical history included asthma and premature ventricular contractions. Patient's past drug included aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zyrtec, Lexapro 5mg, sprintec (birth c) and Vit C. On 25-APR-2021 02:30 Patient stated that not sleeping at night, 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Treatment was received for the adverse event Ems came checked pulse and blood pressure gave plan. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were resolving. Information on Lot/Batch number was available. Additional information has been requested.
42 2021-05-07 weakness 20 hours after vaccine, felt weak and fever of 100. Then 48 hours after vaccine, got rash on one arm... Read more
20 hours after vaccine, felt weak and fever of 100. Then 48 hours after vaccine, got rash on one arm. The rash got worse and spread out to both arms, thighs and feet. Went to urgent care and doctor gave me a steroid shot and some allergy medicine. Now wait and see when the rash will go away.
42 2021-05-07 facial pain, migraine, numbness Migraine left temporal head primarily that makes left face go numb. Occasionally goes to right temp... Read more
Migraine left temporal head primarily that makes left face go numb. Occasionally goes to right temple. Makes blinking more frequently. Facial pain. Nothing completely makes it go away but migraine meds help. Blood pressure has been very elevated since vaccine as well. On BP meds 2 x day when was previously as needed. Only had migraines 1x per every few months before that was completely relieved by meds. These headaches are different.
42 2021-05-07 feeling hot 2days after shot, redness and pain at lef arm administered area. At the same time, Redness, pain,, ... Read more
2days after shot, redness and pain at lef arm administered area. At the same time, Redness, pain,, warmth, swelling at epidermoid cyst at mid chest, seems cyst ruptured. Arm swelling became better, however 8 days later, injestion site became red, hot swollen with itchness. Redness became bigger at lest arm and stared taking benadrl daily. Redness of lest arm improved but still red today 5/8/21. Cyst at midchest is still red. Pending to see dermatologist on 5/11/21.
42 2021-05-07 numbness Facial numbness left side only, occurred within an hour of injection, lasted 10+ days
42 2021-05-07 migraine She could even barely make it to give herself to go pee, she was completely immobilized.; Migraine/l... Read more
She could even barely make it to give herself to go pee, she was completely immobilized.; Migraine/light sensitive/nausea/headache; Extremely dizzy; Painful and scary; scary; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the 1st of 2 reports. A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) (at the age of 42-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she woke up at 6:00 in the morning (on 17Apr2021), there were on migraine, light sensitive, extremely nauseous and extremely dizzy. She could even barely make it to give herself to go pee, she was completely immobilized. She was that nauseous and that dizzy, she was staying in the bed she could not do anything else; she could not get in the kitchen or get something to drink. She took a MOTRIN (as a treatment) around 3 after, she was still felling the symptoms, migraine got disappeared, she was able to move around but eventually got better headache. She was painful and scary. The patient outcome of migraine was recovered and the outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) :PFIZER INC-2021479302 same reporter, drug, different patient and event
42 2021-05-07 muscle spasms I noticed a more severe menstrual cycle the month of my second dose. More severe hormonal imbalance,... Read more
I noticed a more severe menstrual cycle the month of my second dose. More severe hormonal imbalance, painful cramps, heavier flow, and painful constipation.
42 2021-05-07 tingling, numbness -lightheaded -weakness in legs -tingling in the head, face and strange sensations that would go fro... Read more
-lightheaded -weakness in legs -tingling in the head, face and strange sensations that would go from the top of my head and go down my body -heart palpitations -general cloudiness in the head one night I woke up and had to concentrate very hard to think and to speak like having a stroke -numbness in face -face felt swollen for a day or two -itchy for a day 3 weeks later and some of these have subsided, but I still feel off and on tingling, strange sensations, lightheaded and weakness at times.
42 2021-05-08 bell's palsy, facial paralysis, numbness, face paralysis I received the second COVID vaccine (Pfizer) on 5/1/21 at 11:15am (my first vaccine was on 4/10/21; ... Read more
I received the second COVID vaccine (Pfizer) on 5/1/21 at 11:15am (my first vaccine was on 4/10/21; no significant side effects at that time). Around 8pm that same day I felt some muscle ache-type feelings at the base of my skull and behind my right ear. My right top lip also felt a bit tingly and slightly numb. The next day (5/2/21) the whole right side of my face drooped. My facial muscles could not move and felt weak and numb. I could not completely close my right eye and my smile was crooked. I reached out to my primary care doctor (I am currently in another country and received the shot here), and was advised to go to the ER. On 5/4/21 I was officially diagnosed with having Bell's Palsy and was prescribed Prednisone and Valacyclovir to take for 1 week.
42 2021-05-08 burning sensation Burning sensation on the back of my neck, up behind my ear, and on my scalp. After the first one I ... Read more
Burning sensation on the back of my neck, up behind my ear, and on my scalp. After the first one I had the same sensation under my arm.
42 2021-05-09 flushing Pt with Hx of Sulfa, Iodine, Shellfish, Calcitonin allergies. Sx: Chole (2004) Pt has Flushing/sweat... Read more
Pt with Hx of Sulfa, Iodine, Shellfish, Calcitonin allergies. Sx: Chole (2004) Pt has Flushing/sweating, dizziness, and Nausea. BP 76/64, HR 86, RR 18 -- > 138/77, 80 -- > 126/71, 65. patient stable and released from the vaccination site.
42 2021-05-09 numbness 30 mins after injection in left arm - numbness progressing up left side into neck and face and also ... Read more
30 mins after injection in left arm - numbness progressing up left side into neck and face and also down the left side of body.
42 2021-05-09 pain in extremity, night sweats On 5/8/21 I received the 1st dose of Pfizer at 12:00 pm at hospital. I was tired when I went back to... Read more
On 5/8/21 I received the 1st dose of Pfizer at 12:00 pm at hospital. I was tired when I went back to work at 2:00 pm but was able to work. Pain in my right arm was starting to be felt by evening of 5/8. In the middle if the night of 5/8 I had night sweats and tightness in my chest with the sore arm. The morning of 5/9 at about 9:00 I starting getting random sharp pain on each side if my body by my hip area, maybe my kidneys throughout the day along with the pain in my arm continued and the tight chest and sweats went away. By Monday 5/10 I no longer felt pain in my arm or sharp pains but will remain cautious of it coming back in my kidneys area on each side of my body. My next shot is June 4th but notified my Dr. On 5/10/2021
42 2021-05-09 tingling, nerve pain Patient is experiencing nerve pain and tingling in both legs
42 2021-05-09 tremor, pain in extremity, feeling cold 6 hours post-shot I briefly had a sharp headache & intense fatigue, but came & went in just about ha... Read more
6 hours post-shot I briefly had a sharp headache & intense fatigue, but came & went in just about half an hour. Exactly 12 hours after my second Pfizer covid vaccine shot, I woke up at 2:25am shaking with cold for approx. 2 hours: no fever, but couldn't stop shaking or feeling freezing even after putting on two thick sweaters & four wool/down blankets. Followed by intense piercing/pressurized headache coming in waves for about the next 10 hours. At the 24-hour mark post-shot, I felt 100% better. However the same intense shaking/cold (without a fever) came back again at 30 hours post-shot and lasted another 2hrs (example of the intense shaking: my hand was shaking so hard I couldn't hold a spoon to eat soup). Felt better with a burst of energy after that which caused insomnia for a few hours (9:30pm-1:30am). Headache never returned. No arm pain until 12 hours post-shot and is still pretty painful 54 hours later. Finally, I didn't believe the anecdotal reports about the vaccine affecting menstrual cycles, but do want to mention that 48 hours post-shot my period arrived five days early; that has only happened to me once in my life (7 years ago), so I do wonder if it's connected to the "shock" the vaccine apparently gave my body (as evidenced by the cold/shaking/headache experience).
42 2021-05-10 inability to speak, pain in extremity fumbling over words; metallic taste; dizziness; daily headaches; Sore arm; Sore armpit on arm of inj... Read more
fumbling over words; metallic taste; dizziness; daily headaches; Sore arm; Sore armpit on arm of injection site; Waves of feeling like my body was giving up; Fever; Spontaneous conjunctivitis; Skin soreness; Chest tightness; Itchiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EW0153), via an unspecified route of administration, left arm on 09Apr2021 at 09:45 (at the age of 42-years old) at a single dose for COVID-19 immunization. Medical history included allergy to peppers and COVID-19. The patient's concomitant medications included NSAIDs. No other vaccine was given in four weeks. It was unknown if the patient was pregnant. On 09Apr2021 at 16:45, the patient experienced sore arm, sore armpit on arm of injection site, waves of feeling like my body was giving up, fever, spontaneous conjunctivitis, skin soreness, chest tightness and itchiness and on 10Apr2021 at 09:30, the patient experienced fumbling over words, metallic taste, dizziness and daily headaches on 10Apr2021 at 09:30. The patient did not receive any treatment for the events. Since vaccination, the patient has not been tested for COVID-19 The outcome of the events sore arm, sore armpit on arm of injection site, waves of feeling like my body was giving up, fever, spontaneous conjunctivitis, skin soreness, chest tightness and itchiness was recovering; and the outcome of the events fumbling over words, metallic taste, dizziness and daily headaches was not recovered. No follow up attempts are needed. No further information is expected.
42 2021-05-10 tingling, burning sensation There was a full, tingling feeling in my right cheek, below my eye almost immediately after the shot... Read more
There was a full, tingling feeling in my right cheek, below my eye almost immediately after the shot. Four days later, I developed stinging and swelling ion the outside of that same eye and underneath. Today is day 6 and my right eye and cheek are still swollen, itchy and burning.
42 2021-05-10 tingling My heart was racing.132bpm; I felt lightheaded; tightness in throat; tingling in my arms and hand; T... Read more
My heart was racing.132bpm; I felt lightheaded; tightness in throat; tingling in my arms and hand; This is a spontaneous report from a contactable consumer (Patient). A 42-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 05Feb2021 15:00 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included known allergies to Pineapple, Bananas, onions, several environmental allergies; asthma. Patient didn't have COVID prior vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); cromoglicate sodium (ALLERGY) shot; clarithromycin (CLARITIN); mometasone furoate (FLONASE); fluticasone propionate (PROAIR); all taken for an unspecified indication, start and stop date were not reported. No other vaccines were administered in four weeks. Around 8 minutes after vaccine (as reported) patient felt lightheaded, tightness in throat and tingling in her arms and hand. Her heart was racing.132bpm. She told the workers and was taken by ambulance to the hospital. Adverse events start from 05Feb2021 03:15 PM and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent car. Treatment received included Oxygen, benadryl shot. The outcome of the events was recovering. COVID was not tested post vaccination. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
42 2021-05-11 bell's palsy Bell's Palsy
42 2021-05-11 cold sweat, weakness Pt had x 1 episode of syncope with complete LOC. Pt received COVID-19 vaccine and onset of symptoms ... Read more
Pt had x 1 episode of syncope with complete LOC. Pt received COVID-19 vaccine and onset of symptoms started during her 15 minute shot time. Pt was sitting in chair when weakness and nausea started. Pt became diaphoretic and was assisted to the ground by the clinic nurse. Nursing staff denies head trauma during syncopal episode. Pt visibly pale upon arrival to ED, skin moist and clammy. No rash or swelling.
42 2021-05-11 facial paralysis Patient reported significant unilateral eye pain behind her left eye ~15 minutes following injection... Read more
Patient reported significant unilateral eye pain behind her left eye ~15 minutes following injection of second dose. ~20 minutes after vaccine injection, patient developed some facial droop on her left side. Initial patient was given juice and was given powder acetominophen by her mother. After facial droop was noted, EMS was contacted for transport to local ED
42 2021-05-11 migraine Exactly 24 hours after I received the first COVID shot (4/3), I got a sudden a migraine headache tha... Read more
Exactly 24 hours after I received the first COVID shot (4/3), I got a sudden a migraine headache that lasted approximately 8 hours , then subsided. I have never had a migraine before in my life I felt OK 2 days after receiving the shot, however, on the 3rd day (4/5), I developed intense jaw pain and locking with muscle stiffness and headaches. For almost a week, I could not close my mouth all the way to chew. Once I was able to close my mouth again, it was painful to open it all the way for an additional week. All told, I had the headache and jaw pain/locking for 2 weeks total. I was seen by a specialist but because the pain went away as mysteriously as it came, I am not currently under any medical care for this condition. It's notable that I had zero side effects from the second shot, which I got on 5/4. One thing I have noticed is that my jaw is tighter than it was before (but no lingering pain). I notice that I am grinding my teeth and that is not an issue I had prior to receiving the vaccine.
42 2021-05-12 feeling hot, tingling I received the injection and was told to wait for 15 minutes. Shortly after receiving the shot, I ha... Read more
I received the injection and was told to wait for 15 minutes. Shortly after receiving the shot, I had to use the restroom, so I asked if it was ok to do that before I sat for the 15 minutes. As I was walking to the bathroom, I felt a warm tingling sensation go through my arms (almost as if I could feel the injection going through my veins) and then the sensation traveled down my legs and my heart started RACING. This all happened within two to three minutes after receiving the shot. At first I just thought it was odd, but as I kept walking my heart rate continued to skyrocket and I did not like the way I felt. I went to the EMTs and they laid me down and hooked me up to a blood pressure machine. My blood pressure was significantly elevated (which is very unusual for me). As someone with neurocardiogenic syncope, my blood pressure typically drops - the way I felt was not at all in line with a syncopal episode. My heart rate remained elevated while at rest, but did come down a little bit after about 20 minutes; my blood pressure would also come down a bit while at rest but as I would lift my head (even just a little bit) to drink something my blood pressure and heart rate would again sky rocket. This went on for 1.5 hours. After about 2 hours, I was finally able to sit up without my blood pressure and heart rate going through the roof, but I felt simply awful. For the next two weeks I felt light headed (as if my head was detached from my body) and dizzy. I couldn't get out of bed in the morning without drinking a gatorade as I felt so weak and shaky. I developed significant heart palpitations that lasted for a solid month. Additionally, I am someone who has always gotten a period at 27-28 days. I had my regular period two days after vaccination (which was when it was due), but then I got it again 16 days later. That has never before in my life happened to me. Not during illness or times of high stress. Somehow I had a significant reaction to this vaccine and my cardiologist advised that I do not get the second.
42 2021-05-12 hot flush, feeling hot, migraine 14 hrs after-102.9 temp, sever chills and hot sweatshirt; 14-32 hrs after- between 101.4 and 102.9 ... Read more
14 hrs after-102.9 temp, sever chills and hot sweatshirt; 14-32 hrs after- between 101.4 and 102.9 temp, severe chills, hot sweats, migraine, body aches; 33-49hrs after- 103.9 temp several times with a low of 102.4. Severe chills, severe hot sweats, migraine, dizziness, heaviness in chest swollen lymph nodes at collar, abdominal pains 50-68 hrs after- 101 temp decreasing to 100.4. Migraine, abdominal pain, dizziness, lymph nodes at collar and armpits swollen badly, arm at shot site extremely red, hot, swollen, hard and itchy; 69-82 hrs after- temp between 99.7 and 100.1.Migraine, nausea, abdominal pain, dizziness, lymph nodes at collar and armpits swollen badly, arm at shot site extremely red, hot, swollen, hard and itchy.
42 2021-05-12 hot flush Fever 102.0 degrees fahrenheit, chills, hot flashes, dull headache, upset stomach, extreme groggines... Read more
Fever 102.0 degrees fahrenheit, chills, hot flashes, dull headache, upset stomach, extreme grogginess. Severe symptoms lasting one day. Grogginess lasting into the second day after vaccination.
42 2021-05-12 migraine 102 fever migraine headache severe joint pain lasted 48 hours
42 2021-05-12 muscle spasms Menstrual irregularity. I cramped and bled for 15 days which has never before happened in my life. ... Read more
Menstrual irregularity. I cramped and bled for 15 days which has never before happened in my life. Cycle is normally 5-7 days with 2-3 heavy flow days in the middle and intermittent cramping. Also experienced Mild nausea and sleepiness.
42 2021-05-12 tremor, burning sensation Pain was stabbing and burning/Body ache; Shingles; Left lower shoulder blade pain; Stabbing pain tha... Read more
Pain was stabbing and burning/Body ache; Shingles; Left lower shoulder blade pain; Stabbing pain that was radiating around her rib cage to her left breast; High fever/Fever was 102, fluctuated from 102-103; Nausea; Freezing/Chills; Shaking/Trembling; Burning up; Patient received 1st dose on 07Jan2021 and the 2nd dose 18 days after on 24Jan2021; Patient received 1st dose on 07Jan2021 and the 2nd dose 18 days after on 24Jan2021; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL9262), dose 2, via an unspecified route of administration on 24Jan2021 (at the age of 42-years-old) as 2nd dose, single for COVID-19 immunization. Medical history included chickenpox when she was a kid. The patient has no concomitant medications. The patient received the 1st dose of BNT162B2 (lot number: EK4176) on 07Jan2021 for COVID-19 immunization. The patient had no prior vaccinations within 4 weeks of the administration of BNT162B2. The patient received the 1st dose on 07Jan2021 and the 2nd dose 18 days after on 24Jan2021. The patient reported she was a healthy individual and hasn't gone to the doctor or anything. She hasn't call out of work or anything, but she called out for work after her 2nd vaccine dose, she was out for a week. On 25Jan2021, she had a high fever (fever was 102, fluctuated from 102-103) that would not break and nausea. The fever started 12-13 hours after the vaccine which stayed at 102-103 and made her feel nauseous. The patient felt she was freezing, shaking, and burning up. She believed the body aches and nausea aches came from trembling. The patient also had the chills. The patient drank lots of fluids, had soup, and Tylenol with the high fever. These symptoms all happened at the same time and she recovered completely. On 20Mar2021, a month and a half after the patient's 2nd dose, the patient started getting symptoms after her 43rd birthday. She started to develop pain in her lower left shoulder blade. She didn't know if she pulled or twisted it wrong. The pain increased by 21Mar2021. On 24Mar2021 at work, the patient's supervisor asked why she was using a heat pack. She told her supervisor that she was having stabbing pain that was radiating around her rib cage to her left breast. The supervisor asked if it was burning and she had a rash. The patient confirmed she had no rash. It was a deep excruciating pain like someone is hitting her with a bat or stabbing her. The patient added that the pain started medially, on the inner part of her shoulder blade. She was later diagnosed with shingles. No relevant tests were performed. Therapeutic measures were taken as a result of the events shoulder blade pain and chest pain (heat pack); and fever (Tylenol). The outcome of the events shoulder blade pain and shingles was not recovered while the outcome of the events fever, nausea, chills, tremor, and burning sensation was recovered on 29Jan2021. The outcome of the remaining events was unknown.
42 2021-05-13 feeling hot, tingling On 1/12/2021 patient received dose one of Pfizer COVID vaccine, complained of prickling of upper ext... Read more
On 1/12/2021 patient received dose one of Pfizer COVID vaccine, complained of prickling of upper extremities, and mid back, no breathing difficulties, 50mg IM diphenhydramine administered, symptoms resolved. Patient was advised by her PCP to take oral diphenhydramine prior to her second dose which pt. reports she did (50mg PO Benadryl) on 2/3/21 at 230PM in advance of dose 2 appt. On 2/3/2021 3:10 PM Pfizer COVID vaccine dose 2 was administered. At 3:50, pt reported the same prickling sensation as previous vaccine dose, moved from respite area to exam room, Health officer was consulted, decision was made to give IM Benadryl. When NP returned to exam room, patient's symptoms had progressed to feeling itchy and hot, which then quickly progressed to c/o tingling lips and roof of mouth. facial erythema and eyelid edema were noted, at 3:59PM epipen 0.3mg dose administered, EMS activated, vital signs monitored and stable, paramedics arrived at 4:07 and assumed care, Pt was alert and oriented and speaking throughout, pt was transported to ED at 4:15PM.
42 2021-05-13 pain in extremity Full body aches, fever, pain in both legs
42 2021-05-14 migraine migraine, body aches, tender scalp, nausea
42 2021-05-14 muscle twitching, pain in extremity, tingling, numbness Twitching in hands, arms, back, legs and face, even while sleeping. Pain in thighs and calves, ting... Read more
Twitching in hands, arms, back, legs and face, even while sleeping. Pain in thighs and calves, tingling numbness on left side of face
42 2021-05-14 pain in extremity Sore arm to the point of unusable. Bad neck and headache. Sore joints and overall feeling of being u... Read more
Sore arm to the point of unusable. Bad neck and headache. Sore joints and overall feeling of being unwell.
42 2021-05-14 pain in extremity Swollen tounge about 12:10ish. Tired and lethargic by 2:00- 3:00 andtook a nap. Felt very drowsy/ ... Read more
Swollen tounge about 12:10ish. Tired and lethargic by 2:00- 3:00 andtook a nap. Felt very drowsy/ dizzy over dinner with family about 6:20 ish. Strange taste in mouth since about 1:00 pm or so. The taste is kind of chemically. Left arm sore.
42 2021-05-14 tingling, numbness 15 minutes after shot left leg and foot feel asleep. 30 minutes after shot started experiencing inte... Read more
15 minutes after shot left leg and foot feel asleep. 30 minutes after shot started experiencing intermittent pins and needles sensations through out entire body (legs, feet, arms, hands and top lip). Right hand and arm would fall asleep randomly and loose strength. Various parts of body would feel numb to the touch, (back of calves, stomach, cheek). 1 week later and still experiencing these symptoms intermittently throughout the day after my second dose of Pfizer. Note, first dose of Pfizer I only experienced sore arm. Second dose is when what I presume to be nerve issues arose.
42 2021-05-15 numbness, pain in extremity The young lady gave me injection on BACK of my arm. It was extremely painful and burned. I felt liqu... Read more
The young lady gave me injection on BACK of my arm. It was extremely painful and burned. I felt liquid going in my arm and it hurt when withdrawing needle. Within a week my right leg (back) was in so much pain I went to my Dr thinking it was a blood clot. Then my lower back started a few days later. Then my left pinky and ring finger started going numb as well as my palm. Within last few weeks I have had on and off rashes along the radial nerve of both arm. Painful finger length rash under my wrists towards my elbows. Last week my shoulders and neck started this same pain. It is not the actual vaccine, it is where and how it was injected. I do not think she got the muscle I believe she hit a nerve. I am going to a Neurologist.
42 2021-05-15 muscle twitching, tremor Muscle twitches began in feet on 4/18 and quickly spread throughout body, affecting almost all body ... Read more
Muscle twitches began in feet on 4/18 and quickly spread throughout body, affecting almost all body parts (hands, calves, buttocks, quadriceps, hamstrings, abdomen, face [a bit] and arms). I have also experienced vibration sensations in the feet and in one arm. One toe twitched and buzzed for 30 minutes straight. I am not sure about the difference between a muscle twitch and a muscle spasm, but I might have experienced some spasms also. There are also hand tremors, which have not to my knowledge been present before. There might have been some tingling/pins and needles and burning, but I'm not sure if these were real or psychosomatic. Symptoms come and go but are undiminished and still present on 5/15/21. I have had some soft stools but am obviously very anxious about this condition.
42 2021-05-15 pain in extremity Painful swollen and bruised part of my left leg and left arm.
42 2021-05-15 pain in extremity started the day of vaccines with a sore arm later on in the evening sore arm near shoulder where vac... Read more
started the day of vaccines with a sore arm later on in the evening sore arm near shoulder where vaccine was given for about 24 hours and then it seemed fine about a week later arm started hurting halfway down my upper arm there is a lump on the outside my arm is swollen lymph nodes are swollen the arm feels tight and tired sometimes get tingly sensations in it. I was supposed to receive my second vaccine on May 8 did not get it because of the reaction that I am still experiencing would like to get the second one I am very scared considering I am still having A very painful reaction
42 2021-05-17 burning sensation, pain in extremity, numbness Numbness and Pain in Left Hand following Second Pfizer Shot. Joints at Left Pointer and Middle Fing... Read more
Numbness and Pain in Left Hand following Second Pfizer Shot. Joints at Left Pointer and Middle Finger Red, "on fire".....Left Hand Swollen. I cannot lift, type, open doors, hold a coffee cup, tie my shoes, put earrings in, etc.
42 2021-05-17 hot flush, numbness, tingling, tremor Started with numbing and tingling on the right cheek and the right side of my face was drooping @ 10... Read more
Started with numbing and tingling on the right cheek and the right side of my face was drooping @ 10:30am on 1/21 the day after my 2nd dose. It proceeded down the entire side of my body, unable to move the right arm or right leg as if I were paralyzed. Hot and cold flashes along with shaking uncontrollably. I even became very nauseous. This lasted for 6-7 hours. 1/22 and 1/23 just very fatigued slept the majority of both days.
42 2021-05-17 migraine Headache; migraine; chills; muscle soreness; tiredness; lethargy; loss of appetite; nausea; This is ... Read more
Headache; migraine; chills; muscle soreness; tiredness; lethargy; loss of appetite; nausea; This is a spontaneous report from a contactable other healthcare professional. A 42-years-old non-pregnant female patient received second dose of BNT162B2 (COMIRNATY, Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EM9810), via an unspecified route of administration, administered on Arm Left on 02Feb2021 11:15 (Age at vaccination: 42 years) as SINGLE dose for covid-19 immunization at Health Clinic/Administration facility. The patient's medical history included asthma from an unknown date, drug hypersensitivity from an unknown date for allergies: penicillin, sulfa drugs, ceclor and Tylenol. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient Concomitant medications within 2 weeks of vaccination included vitamin D NOS (VITAMIN D NOS) for an unspecified indication from an unknown start date. On 12 Jan2021 at 11:45, The patient previously received first dose of BNT162B2 (COMIRNATY, Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3248), via an unspecified route of administration administered on Arm Left as SINGLE dose for COVID-19 immunization. On 03Feb2021 at 3:00 the patient experienced Headache- migraine, chills, muscle soreness, tiredness/ lethargy, loss of appetite with nausea. The seriousness criteria of the events has not resulted in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The patient did not receive any treatment for the events. The outcome of the events was reported as recovered. The events was considered as non-serious. Follow-up attempts are completed. No further information is expected.
42 2021-05-17 pain in extremity Initial noticeable symptom: rapid sinus clearing and nasal drain five minutes after shot, followed b... Read more
Initial noticeable symptom: rapid sinus clearing and nasal drain five minutes after shot, followed by noticeable but bearable dizziness & nausea five minutes after that (it seemed to sweep upward from the back of my neck, like being on a carnival ride with a lot of G force). Dizziness and nausea resolved completely after about five minutes. Sinuses remained clear for 36 hrs. (being spring, I have chronic sinus congestion this time of year due to mild seasonal allergies, so this was noticeable). Stabbing, shooting arm pains, short in duration but painful enough that I had to let my arm hang limply at my side- these were unlike any I have experience before- began about an hour after vaccine and continued off & on for approx. 72 hrs. Headache, nausea, exhaustion were present off and on from several hours after vaccine until about 72 hrs. later, when they resolved. 36 hrs. after vaccine painful, red uveitis set in in both eyes. I have autoimmune issues and am prone to uveitis flares and immediately began taking my prescription prednisolone acetate 1% eye drops 4x day; pain and redness resolved within 36 hrs. of onset. I tapered off eyedrops for the next week. I did not report any of these symptoms to the clinic and have had no other side effects since. I go for my second shot today, will see what happens.
42 2021-05-17 pain in extremity PT RECEIVED HER FIRST PFIZER COVID VACCINE DOSE ON 05/05/2021@2:08PM. PATIENT'S ARM WAS SORE THAT E... Read more
PT RECEIVED HER FIRST PFIZER COVID VACCINE DOSE ON 05/05/2021@2:08PM. PATIENT'S ARM WAS SORE THAT EVENING AND THE NEXT DAY (SHE DESCRIBES IT AS THE TYPE OF SORENESS THAT YOU GET AFTER THE VACCINE). 6 DAYS LATER (AROUND 05/11/2021) SHE STARTED TO HAVE PAIN IN HER SHOULDER BLADER, RIGHT SIDE OF NECK AND BACK OF RIGHT ARM WHERE SHE RECEIVED HER DOSE. SHE HAS SEEN A CHIROPRACTOR (RECOMMENDED SHE SEE A MASSAGE THERAPIST BECAUSE THE SHOULDER AREA WAS STIFF) AND MASSAGE THERAPIST SINCE AND TODAY AFTER RESEARCHING ONLINE SHE CONTACTED THE PHARMACY BECAUSE HER SYMPTOMS MATCH THAT OF SIRVA. PATIENT HAS TAKEN ADVIL BUT WITH NO RELIEF.
42 2021-05-17 tingling Starting in feb i had pain in my left arm. specifically the tendons. then pins and needles started ... Read more
Starting in feb i had pain in my left arm. specifically the tendons. then pins and needles started in my left arm soon after my second shot in march. After second shot i had swelling in my arm pit, chills and fatigue, and some brain fog. On 4/14 i went to the dr and he said i probably hurt my elbow and told me to start taking aleve 2 times a day. on 4/19, i woke up with extreme dizziness. In the morning and at night. I had significant brain fog as well. then pins and needles started in my face and neck. i went back to the dr on 4/19 they started treating me for lymes disease. I had extreme tightness in the back of my neck and base of skull. The brain fog has started to lift. The pins and needles have started to isolate to my chin lips and 1 arm. I still have dizziness although it has become more manageable.
42 2021-05-18 migraine, pain in extremity Pain in the arm and migraines. When I was trying to walk up the steps I had shortness of breath. I t... Read more
Pain in the arm and migraines. When I was trying to walk up the steps I had shortness of breath. I tripped up the steps because I got lightheaded. I went to my doctor. I took Excedrin. I wanted to be sure the SOB was checked. Doctor checked my medication, and took my vitals. BP was high, then I had to wait 45 minutes for the doctor to take my BP again. The second time my BP was taken it was a bit lower.
42 2021-05-18 muscle spasms Magnet sticking to the injection site and sharp shooting pains/spasms throughtout body
42 2021-05-18 speech disorder Pain, fever, swelling, hard knot at injection site, chest pressure, shortness of breath, throat feel... Read more
Pain, fever, swelling, hard knot at injection site, chest pressure, shortness of breath, throat feel like it was swelling shut, cough, difficulty talking. The chest pressure began Sunday morning and readily got worse eventually resulting to a trip to the ER when Benadryl, rescue inhaler, and EPI pen didn?t work.
42 2021-05-18 tremor, tingling Neurological issues of shaking and tremors mostly in her leg; Intermittent tremors or involuntary mu... Read more
Neurological issues of shaking and tremors mostly in her leg; Intermittent tremors or involuntary muscle contractions; Pulsating heaviness in her legs; Severe diarrhea; Loss of appetite; Constipated with no normal bowel movements; Nauseated; Felt run down and fatigued; Pain on the right side of her tail bone and upper right buttocks; Pain on the right side of her tail bone and upper right buttocks; Rash on right of tailbone and upper buttocks that progressed into blistering; Tingling in her hands, low back, and tailbone area; Depression; Original rash was shingles; Herpes simplex virus could have attacked her gastrointestinal system; Mild GI symptoms; This is a spontaneous report from a contactable consumer (patient who is a registered dietician). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 30Mar2021 (Lot Number: ER8732) at the age of 42 years, as first dose, single, for COVID-19 immunization. The patient's medical history included herpes simplex virus (HSV) from 12 years ago (2009) and she has not had any problems with this in a very long time (her lesions would be limited to her vulva area and she has never had an outbreak on her buttocks before). There were no concomitant medications. The patient was experiencing symptoms post COVID-19 vaccine that she wanted to report. She is seeking guidance for treatment or a provider that could help. The patient received the vaccine on 30Mar2021 and then felt run down and fatigued and developed pain on the right side of her tail bone and upper right buttocks on 01Apr2021. On 01Apr2021, she had developed a rash on right of tailbone and upper buttocks that progressed into blistering (rash in that area which then blistered). The patient had tingling in her hands, low back, and tailbone area from 01Apr2021. The patient went to urgent care (physician visit) on 03Apr2021 and was prescribed acyclovir for the symptoms above. The patient saw her primary care provider for this new onset blistered rash and given her history, she was prescribed acyclovir, she took an 8 day course of that but then started to become constipated with no normal bowel movements and started feeling nauseated on 09Apr2021. The patient took that for eight days and felt not 100%; felt bad run down. She stopped Acyclovir on Monday (12Apr2021) and was off it for two days temporarily because she was experiencing nausea and mild gastrointestinal (GI) symptoms in Apr2021. For those two days off it, the patient developed severe diarrhea with a loss of appetite starting on Tuesday (13Apr2021). The patient also had neurological issues of shaking and tremors mostly in her legs and pulsating heaviness in her legs and tingling in hands on 14Apr2021; fatigued; and depression on 01Apr2021 that worsened. She saw her primary care doctor yesterday (15Apr2021) and was prescribed more acyclovir and was started back on it. The doctor told her that herpes simplex virus could have attacked her gastrointestinal system in Apr2021. She has this shaking that feels like it starts in the back of her body that has not subsided, describes the shaking as intermittent tremors or involuntary muscle contractions. Last night (15Apr2021), she also had loss of appetite and diarrhea. The patient went to the emergency room (ER) this morning (16Apr2021) because she woke up at 3:30 and experienced same tremors from night before that went away. The patient went to the ER on 16Apr2021, they did a full work up, did not find anything. The patient was given liter of fluid for shaking and had electrocardiogram (EKG), blood work and chest X-ray that came clear (16Apr2021). She had pictures of rash when first developed on 01Apr2021 and the physician stated that it looked like shingles. The ER provider said she felt like the original rash was shingles instead of herpes simplex virus based on the pictures that the patient showed her. The doctor stated that they had heard of others developing post vaccination shingles. The patient has another follow-up with her primary care physician today (16Apr2021) for further guidance after her ER visit. The patient would like to know if Pfizer has any recommendations for treatment in this situation. The patient wanted someone to shed some light on shingles and treatment; for the first dose. The patient was recovering from "Rash on right of tailbone and upper buttocks that progressed into blistering", "Tingling in her hands, low back, and tailbone area", and "Constipated with no normal bowel movements". The outcome of "Herpes simplex virus could have attacked her gastrointestinal system" and "Pulsating heaviness in her legs" was unknown. The patient had not recovered from the remaining events. No follow-up attempts are needed. No further information is expected.
42 2021-05-19 pain in extremity Arm is very sore and started running a low grade fever 101F. Took 325mg acetaminophen.
42 2021-05-20 feeling hot 15 minutes, subjective SOB and hot feeling, lasted 5 minutes
42 2021-05-20 flushing, numbness After the first shot on March 29th at 9am, my lip went numb almost immediately after the shot for a... Read more
After the first shot on March 29th at 9am, my lip went numb almost immediately after the shot for about an hour. After the second shot April 19th at 9 am, which is the one whose date is noted in the main bracket, my cheeks flushed about 20 minutes after the shot. Within an hour, my cheeks were numb. This time the numbness grew, and spread to my right eye as well. I could not feel my eyelid, my cheeks, and my sight was a little fuzzy. It felt as though I had been injected with Novocain and it lasted for about 5 hours. It was accompanied by a terrible headache.
42 2021-05-20 mild one side paralysis, numbness, discomfort, inability to speak Pt received her first Pfizer COVID-19 vaccine on 4/9/21. She did well during the immediate post vax... Read more
Pt received her first Pfizer COVID-19 vaccine on 4/9/21. She did well during the immediate post vax period and went home stable. Over the course of a few days, she developed word-finding problems, forgetfulness, and numbness / heaviness. On 4/18/21, she called 911 and went to ED for L sided weakness and vertigo. An MRI was done and a questionable brain lesion was found. She was stable and was discharged home with instructions to follow up with her Kaiser PCP. On 5/17/21, she called me to report her experience and believes it's all due to the vaccine.
42 2021-05-20 tingling, slurring Pfizer vaccine - tongue swelled impeding speech, face swollen, tingling in the face, hives on face a... Read more
Pfizer vaccine - tongue swelled impeding speech, face swollen, tingling in the face, hives on face and neck. This passed within 24 hours Tingling in hands and feet - started within five hours of shot has not improved.
42 2021-05-21 weakness At. 10:25am during observation, patient verbalized dizziness and lightheadedness. Vital signs noted:... Read more
At. 10:25am during observation, patient verbalized dizziness and lightheadedness. Vital signs noted: blood pressure 185/99, pulse 80, respiratory 18 02 Sat. 99%. Patient shared medical history of hypertension and migraine headaches. Patient provided information to follow up with primary care physician as soon as possible to treat hypertension. Patient stated husband would transport her to urgent care. Patient was being assisted from chair to wheelchair to exit clinic. She became weak and lethargic. Vital signs were taken again, noted at: blood pressure 204/179, pulse 136, 02 98% , respiratory 22. EMS was called and patient was transported to Medical Center.
42 2021-05-21 numbness Shortly after receiving the first dose, I felt numbness in both my temples. I have never experienced... Read more
Shortly after receiving the first dose, I felt numbness in both my temples. I have never experienced this sensation before. This was a constant feeling throughout the entire day, with occasional 'waves' where the numbness felt more intense. The next day, I still felt it but it wasn't as noticeable. By night time, the numbness had descended behind the ears. The third day (today) I can still feel it every now and then but it is not nearly as strong as on the first day (barely there). I have not consulted a doctor about it because I was not feeling sick otherwise, but I have decided to report it because, with the exception of a single forum, I have not been able to find anything about a similar side effect online to reassure myself that it is normal.
42 2021-05-21 migraine Migraine
42 2021-05-21 muscle spasms Delayed onset of subsequent menstruation followed by intense mood disruption, insomnia, debilitating... Read more
Delayed onset of subsequent menstruation followed by intense mood disruption, insomnia, debilitating unusually intense cramps for 4 hours (treated with ibuprofen) followed by early cessation of period and immediate resumption of PMS, specifically debilitating unusually intense cramps for 12 hours (ongoing, not fully redressed by ibuprofen)
42 2021-05-21 muscle twitching, tremor, restless legs syndrome, grand mal seizure, migraine Chills, body aches, shakiness, twitching in my hands & feet, feeling of restless leg syndrome, incre... Read more
Chills, body aches, shakiness, twitching in my hands & feet, feeling of restless leg syndrome, increased seizure activity including petite mals and grand mals, migraines, raising my voice for no apparent reason (not angry, just catching myself yelling and not knowing why) involuntary crying at random, increased instances of narcoleptic episodes, hallucinations, nausea and vomiting
42 2021-05-21 pain in extremity I believe the shot was given too high and I felt the needle enter by shoulder bone area. It was abov... Read more
I believe the shot was given too high and I felt the needle enter by shoulder bone area. It was above the muscle and not overly painful at the time but I did feel it much more than my first shot. It became sore within and hour or so - not as much muscle pain but more joint pain. I believe the worker was an amazing nurse but the staff was not being overseen and all probably needs to be reminding not to give shots too high. I have an appointment with a doctor Monday, I do not know if there will be last effects. Now I have lots of pain when lifting my arm or putting weight on it.
42 2021-05-21 tingling, pain in extremity 7 severe armpit boils (unter the skin) with 103 degree fever. Dark bruising, severe tenderness of sk... Read more
7 severe armpit boils (unter the skin) with 103 degree fever. Dark bruising, severe tenderness of skin, boils approx. 1 - 3 inch diameter. I have never had this happen before. I have never had any abcesses this bad before. Lanced on 5/21 in. Applied Emu oil/Neem oil mixture. Utilized warm wet washcloth. Started course of antibiotics on May 19. The left arm was sore and painful since 2nd dose of vaccine with tingling and pain in finger tips from 5/6 - 5/22
42 2021-05-22 pain in extremity Severe shoulder pain, and arm pain, tenderness in arm, limited range of motion, arm weakness, should... Read more
Severe shoulder pain, and arm pain, tenderness in arm, limited range of motion, arm weakness, shoulder stiffness, limitations of daily activities, reaching, driving, and disturbed sleep, going on over 2 months now
42 2021-05-22 pain in extremity Mild fatigue and headache day after first shot only, and mildly sore arm for a week or so. After sec... Read more
Mild fatigue and headache day after first shot only, and mildly sore arm for a week or so. After second shot -3 days very sleepy, increased chest pain, increasing activity intolerance, then less sleepy but severe activity intolerance, palpitations and tachycardia sitting up for extended periods, SOB with walking distances or stairs and sharp chest pains again, waking from sleep SOB, unable to tolerate lying flat on back with SOB. It was like much earlier in the long Covid again. About 1 month after the vaccine I took prednisone 20mg for 5 days, against medical advice and all symptoms improved, to just a little worse than before the vaccine. My mother had a similar reaction to the first dose and was hospitalized, and got no testing or treatment, just monitoring. She had Covid at the same time as me.
42 2021-05-23 bell's palsy I had Bells Palsy in 1997 and again in 2000. I don't remember if the same side was affected. I star... Read more
I had Bells Palsy in 1997 and again in 2000. I don't remember if the same side was affected. I started to develop symptoms of Bells Palsy again on Sunday May 16 in the evening. It got progressively worse so I went to my primary care provider on Wednesday, May 19, 2021. PA-C ran a variety of tests and prescribed prednisone. She also made a referral to a neurologist. I have not gotten an appointment set for the neurologist. My symptoms have continued to worsen and I will contact my primary care provider later today about that. She ran Lyme's disease and other tick borne illness tests. We live in a high Lyme disease area. I had a large tick on me (not sure if was actually attached) a few days prior.
42 2021-05-23 muscle spasms Severe vaginal bleeding not in line with the normal menstrual cycle. An extreme number of nickel-si... Read more
Severe vaginal bleeding not in line with the normal menstrual cycle. An extreme number of nickel-size clots and medium to severe cramping, which is not normal at all for me.
42 2021-05-23 nerve pain, pain in extremity, breast pain A Thursday, nerve pain on the left side, neck, arm and trunk and axillary region over the left breas... Read more
A Thursday, nerve pain on the left side, neck, arm and trunk and axillary region over the left breast truncal area; radiating over the shoulder and down the arm. Aching and a deep neuropathy kind of feeling; very weird feeling. I thought it was a pinched nerve. I went to my chiropractor first - Friday. He thought it was shingles even though there was no rash. I started to have a rash on Saturday, on my breast, axillary under my armpit and left scapula. I went to Urgent Care, around the middle of February. I received an antiviral, Valtrex to take for two weeks. It was super high dosage. They could tell by the pattern; it follow a dermatome classic for shingles. I was better by the time I finished the medication.
42 2021-05-24 numbness, pain in extremity Numbness in left hand. Left arm heavy and sore.Fever. Chills. Cough. Heart palpable. Shortness of br... Read more
Numbness in left hand. Left arm heavy and sore.Fever. Chills. Cough. Heart palpable. Shortness of breath. Stomach cramps. Nausea. Diarrhea. Pain behind eyes. Burning itchy skin. Uterine bleeding.
42 2021-05-24 numbness 1/29 Vaccination at 1022. Three minutes later, I sat down and then started feeling numbness. My HR w... Read more
1/29 Vaccination at 1022. Three minutes later, I sat down and then started feeling numbness. My HR was increasing at rest. I told the nurse. She monitored. I hadn't ate anything, she directed me to take something and check vitals. 144 HR. 160/100 BP. I do not have high BP. They gave me some oranges. They were monitoring me for 15 minutes. 136,150. HR kept fluctuating between and I was just sitting for an hour. They asked if I wanted to tx to ER. In the ER, same heart questions, EKG, HR still not going down, gave Ativan. I have never taken before. After an hour, eventually I was very sleepy. The doctor never explained what happened but said to take the second dose. I do not know what had happened, if this happened before, I just wanted to go home. I have never had anxiety before, I am not an anxious person. I was ready physically and mentally for the vaccine. I think related to vaccine not to me being anxious. *COVID+; 10/2021 *PCM; recommended Ativan for 2nd dose. I decided not to receive. My BP was never that high. I don't know what would happen the second time. *Have had a couple more episodes of heart palpitations since. Woke me up at night. 2-3 more times out of no where. 115 and stayed like that for 30 minutes. It has been 3 months since last episode. It can just 'happen' at rest.
42 2021-05-24 tingling dose 1: 05Jan2021; dose 2: 22Jan2021; dose 1: 05Jan2021; dose 2: 22Jan2021; ear ache; Cough; congest... Read more
dose 1: 05Jan2021; dose 2: 22Jan2021; dose 1: 05Jan2021; dose 2: 22Jan2021; ear ache; Cough; congestion; loss of appetite; Headaches; fatigue; right axillary lymph node swollen; Dizziness; Room spinning; nausea; body and face tingling; chills; body aches; insomnia; This is a spontaneous report from a contactable nurse reporting for herself. This 42-year-old female nurse (Patient) reported that: A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 22Jan2021 11:00 AM (Batch/Lot Number: EL3249) as SINGLE DOSE for COVID-19 immunization. Patient also received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 05Jan2021 09:30 AM, (Batch/Lot Number: EK9231) as SINGLE DOSE for COVID-19 immunization (time interval between two doses: 18 days). Medical history included drug hypersensitivity, to Penicillin, tetracycline. Concomitant medication included cetirizine hydrochloride (ZYRTEC) 1x/day and Multivitamins. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 22Jan2021 10:00 PM, the patient experienced dizziness, room spinning, nausea, body and face tingling, chills, body aches and insomnia. Also, it was reported that, the patient had fatigue, right axillary lymph node swollen on 23Jan2021, on 24Jan2021: dizziness had nausea. On 26Jan2021: Dizziness, nausea, loss of appetite, tingling face and body and headache. On 27Jan2021: Dizziness, nausea, tingling face and body, cough, congestion and on 28Jan2021: Cough, congestion, earache. On 29Jan2021, the patient presented with dizziness, tingling face and body, cough congestion, and headache. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for adverse events. The patient was recovering from all the event at time of reporting. Follow-up attempts are completed. No further information is expected.
42 2021-05-24 speech disorder Patient reports receiving Pfizer vaccine 5/21/2021 and insomnia since receiving vaccine and feeling ... Read more
Patient reports receiving Pfizer vaccine 5/21/2021 and insomnia since receiving vaccine and feeling "electricity" throughout body. Per patient, went to urgent care on 5/24/21 in PM, had normal vital signs, and was given hydroxyzine and Flexeril and was able to sleep for 2 hours overnight, but it was not a restful sleep. When I spoke with patient on the phone, patient was agitated, and had pressured speech, and appeared to be in pain. I prescribed Lunesta 3 mg and told patient if unable to sleep, to go to Emergency Department for further evaluation.
42 2021-05-25 tremor, weakness Recurring smaller allergic reactions; Felt a little unwell; I made it 2 blocks when my pulse went up... Read more
Recurring smaller allergic reactions; Felt a little unwell; I made it 2 blocks when my pulse went up to 134bpm; i felt nauseous; Shaky; Weak; Head and nose pressure; Head and nose pressure; Throat felt tight; Congested; My symptoms became rapidly worse; Teeth chattering; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EW0172), via an unspecified route of administration, on 04May2021 at 09:30 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing, systemic lupus erythematosus from an unknown date and unknown if ongoing. The patient reports being allergic to dairy, wheat, eggs, sesame, ginger, garlic, onion, tomato and tree nuts from unspecified dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. The vaccine was administered in a hospital. The patient did not have COVID-19 prior to being vaccinated. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EW0150), via an unspecified route of administration on an unspecified date in Apr2021 at 09:30 as a single dose in the left arm for COVID-19 immunization. Concomitant medications included montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported; etonogestrel (NEXPLANON) taken for an unspecified indication, start and stop date were not reported; valacyclovir (VALACYCLOVIR) taken for an unspecified indication, start and stop date were not reported; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccinations within 4 weeks prior to the COVID-19 vaccine. The patient previously took sulfa drugs and experienced drug hypersensitivity, ADVAIR discus and experienced drug hypersensitivity and an unspecified flu vaccine and experienced drug hypersensitivity. The patient reported that, after receiving the 2nd dose of the vaccine, she sat for the required 15 min. Because of allergic responses to food and the flu vaccine in the past she had her Apple iwatch set up to moniter her heartrate; it was 65bpm at that time. She felt a little unwell but thought she was ok. So she left at the 15 min mark. She walked to her car and as she left her symptoms became rapidly worse. She made it 2 blocks when her pulse went up to 134bpm. She felt nauseous, shaky and weak, teeth chattering, head and nose pressure, throat felt tight and congested. She was not sure if she was going to throw up or pass out. She did not feel well. She went back to the vaccination site and her blood pressure was ok so they did not administer the Epi pen. Instead they gave her Benadryl and observed her for 1 1/2hrs. She experienced recurring smaller allergic reactions over the next couple days. She has taken her Prednisone pills to help.She has an upcoming appointment for allergy testing to some of the vaccine ingredients. The patient experienced recurring smaller allergic reactions beginning on 04May2021 09:45 with outcome of recovering, felt a little unwell on 04May2021 09:45 with outcome of recovering, pulse went up to 134bpm on 04May2021 09:45 with outcome of recovering, felt nauseous on 04May2021 09:45 with outcome of recovering, shaky on 04May2021 09:45 with outcome of recovering, weak on 04May2021 09:45 with outcome of recovering, head and nose pressure on 04May2021 09:45 with outcome of recovering, head and nose pressure on 04May2021 09:45 with outcome of recovering, throat felt tight on 04May2021 09:45 with outcome of recovering, congested on 04May2021 09:45 with outcome of recovering, symptoms became rapidly worse on 04May2021 09:45 with outcome of recovering, teeth chattering on 04May2021 09:45 with outcome of recovering. The patient underwent lab tests and procedures which included heart rate of 65 bpm on 04May2021 and heart rate of 134 bpm on 04May2021. Therapeutic measures were taken as a result of the events and included Benadryl and prednisone.
42 2021-05-25 unresponsive to stimuli, flushing Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: P... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient had began feeling anxiety during check in , reported fear of needles, after injection she became pale, sweating, and lost consciousness in a seated position, there was no fall associated with this event. She was not responding to her husband or pharmacist, pharmacist checked pulse and breathing, both were fine, prompted student to call 911. After a few minutes she regained consiousness and therefore no response from ems.After observation of 30 minutes was fine and left with her husband.
42 2021-05-26 weakness, pain in extremity After my 1st shot, I noticed abnormal stiffness and soreness in my left, I was advised to apply ice ... Read more
After my 1st shot, I noticed abnormal stiffness and soreness in my left, I was advised to apply ice and heat to the shoulder. I did not pay much attention as I thought it was normal. Approximately 3 days later, I noticed weakness in my left arm and slight limited range of motion. I did bring this to my physician's attention. I was advised it was normally and should clear up in about a week. A week sent by and there was no improvement. I continued to follow in the instructions of ice and Tylenol. I still did not see improvement so at my 2nd vaccination. I asked for guidance from the PT therapist regarding exercises that would help improvement range of motion. I was instructed to do pendulums and overhead raises holding a stick or towel lying down. Again there was no improvement. At this point the weakness is more intense to the point that is I lean on my left arm, it hard to more it, I have difficulty using my left arm to wash my body and it constantly aches even when not in use. I have tried taking tramadol and well as IBUPROFEN but none have yield relief. I was also advised that I have frozen shoulder but there were no symptoms prior to the vaccination received on 03/29/2021
42 2021-05-26 numbness My blood pressure dropped, started getting heart palpitations, feeling short of breath at times, bod... Read more
My blood pressure dropped, started getting heart palpitations, feeling short of breath at times, body (arms/legs) would go numb easy. Would see "stars" at times. Lasted for a good 10-14 days and still don't feel 100% back to normal, but most has subsided.
42 2021-05-26 pain in extremity, numbness I started to get a upset stomach, fever, headache, fatigue, then extreme arm pain through out my arm... Read more
I started to get a upset stomach, fever, headache, fatigue, then extreme arm pain through out my arm into my shoulder and neck. I also experience numbness down my arm into my wrist and fingers. At this same time I got muscle pain all over. Next day I still had the extreme arm pain and numbness as well as fever and muscle pain . I let my physician know about my issues. Two days after and my arm still hurts but am still having air pain, but its more the arm numbness running from my shoulder down to my fingers. Its becoming a problem to be able to do daily activity.
42 2021-05-27 facial paralysis Approximately 48 hours after my second Pfizer Covid-19 vaccine, I experienced partial Facial paralys... Read more
Approximately 48 hours after my second Pfizer Covid-19 vaccine, I experienced partial Facial paralysis on right side of face (primarily upper lip). Symptoms progressively worsened over the next 72 hours. After approximately 6 days post vaccine, facial paralysis began to slightly improve. On Thursday, May 27, 2021 I visited my primary care physician, who suggested I report my adverse reaction to the CDC. I continue to experience slight drooping on the right side of my mouth (upper lip).
42 2021-05-27 feeling cold first night very high fever, headache, chill, body ache, sweating, no appetite. however specifically... Read more
first night very high fever, headache, chill, body ache, sweating, no appetite. however specifically the pain was very intense in the lower back and sides almost like back labor and some lower abdominal and with nausea . then next morning the back pain was the same and still nauseous from pain and noticed a full on rash all over chest neck, back and stomach. called my doctor and they asked to go in and check with blood test and Urine sample. most items were normal on the test except blood in urine and low white blood cell counts which I have to follow up with a second test a week later bec my doctor want to make sure it is not due to vaccine. not sure if these are related. rash is still on , went down a little but not complete with Claritin however it looks like it has come back at the night time. and that is up to now so will see the rest later. ( very healthy normally , no issue before getting the vaccine ) also want to here mention first dose gave me horrible anxiety and depression and paranoia for few days starting few days after which I was told was due to hormone imbalance.
42 2021-05-27 migraine vertigo, nausea, fever, vomiting, chills, migraine, dizziness for 17 hours
42 2021-05-27 pain in extremity Left leg hurting a lot and it feels heavy
42 2021-05-28 feeling cold Pt felt dizzy, took slow deep breaths, then fell asleep onto husband's shoulder in chair for 30 seco... Read more
Pt felt dizzy, took slow deep breaths, then fell asleep onto husband's shoulder in chair for 30 seconds. Pt awoke and said she was cold and shivering, pt admits to some "chest pain", pt's vital signs were: 126/80 mmHg, 91 bpm pulse, 99% O2 sat on room air. Pt stated she has had a panic attack 4 years ago, she stated this episode "felt similar to last time". Pt given candy by staff, warm water, and emotional support by staff and spouse. Pt reported some abdominal pain after the panic attack, but improvement in other symptoms following being given warm water. No medications were administered.
42 2021-05-28 flushing patient came to Med opts one at 1:05 with complaints of being dizzy and slightly nausea. she looked ... Read more
patient came to Med opts one at 1:05 with complaints of being dizzy and slightly nausea. she looked blush in the face and sweaty. husband said she suffers from panic attacks and anxiety. had similar symptoms after she got home from her first dose of pfizer. patient had a hard time keeping her eyes open because she took a klonopin before arriving. patient was given water and an ice pack for the back of her neck. we slowly moved her from a supine position to a sitting position until she felt well enough to move to the wheelchair. patient was here approximately 35 minutes until she felt well enough to be moved to her vehicle. husband drove her home.
42 2021-05-28 numbness Facial numbness especially lips and tongue; Facial numbness especially lips and tongue; This is a sp... Read more
Facial numbness especially lips and tongue; Facial numbness especially lips and tongue; This is a spontaneous report from a contactable consumer (patient). This 42-Year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration in the left arm on 08Apr2021 at 13:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included cat allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient had no concomitant medications. The patient reported that on 08Apr2021 at 16:00 she experienced facial numbness especially lips and tongue which lasted a few weeks. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of facial numbness especially lips and tongue were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
42 2021-05-29 bell's palsy, numbness One day after injection on 5/14/21, got intense painful ache under right ear. It went away after abo... Read more
One day after injection on 5/14/21, got intense painful ache under right ear. It went away after about a day. But then on the evening of 5/24, I found that my right eye was very scratchy. On 5/25, I realized it?s because the right eye would not close all the way. On the evening of 5/25, I found my food kept falling into my right cheek when I ate. On 5/26, I found that my right eye would not blink at all. And my right cheek was numb. My right eyebrow would not raise as high as the left and my smile was crooked. I went to urgent care and they diagnosed me with Bell?s Palsy.
42 2021-05-29 tingling, numbness Fatigue, headaches and unusual sensations in head/scalp/neck area (pressure, numbness, tingling) sta... Read more
Fatigue, headaches and unusual sensations in head/scalp/neck area (pressure, numbness, tingling) started day after shot and continued for weeks before finally seeking medical help two weeks post vaccination. Have since experienced blood pressure fluctuations, anxiety, vertigo, nausea, light-headedness, heart palpitations, ear pressure/throbbing, chest pain and sensations of weakness/numbness on left side of face/head/neck/chest/arm. Two weeks post-vaccine (on 5/11) I met with my endocrinologist to check on my Hashimoto's condition and thyroid/iron bloodwork since I was still feeling fatigued and generally unwell post vaccine.
42 2021-05-31 weakness but I was dizzy/weak; but I was dizzy/weak; weak from lack of appetite and fever; weak from lack of ... Read more
but I was dizzy/weak; but I was dizzy/weak; weak from lack of appetite and fever; weak from lack of appetite and fever; headache; had chills and shivering and couldn't get warm; had chills and shivering and couldn't get warm; My temp started to climb overnight Friday; It felt like my face was going to explode; This is a spontaneous report from a contactable other hcp. A 42-years-old female patient reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch number and expiry date were not reported) via an unspecified route of administration, administered in Arm Left on 29Jan2021 07:00 as single dose for covid-19 immunisation. The patiently previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch number and expiry date were not reported) via an unspecified route of administration, administered in Arm Left on 08Jan2021 11:00 as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. It was reported that the patient got second dose Friday morning, 29Jan2021, at 07:00. By 4 pm on Friday she had chills and shivering, and couldn't get warm. By 6pm on Friday, a headache started. The headache got progressively worse overnight Friday, the worst headache she had ever experienced. It felt like her face was going to explode. Her temperature started to climb overnight Friday. Got up to 101.5 by early Saturday morning. By noon on Saturday, headache started easing up, but was dizzy/weak. By 4:00 pm Saturday she was feeling a lot better, just weak from lack of appetite and fever. The patient underwent lab tests and procedures which included body temperature: started to climb on 29Jan2021, body temperature: 101.5 on 30Jan2021. On an unspecified date, the outcome of the events was resolved. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
42 2021-05-31 weakness dizziness; injections site reactions including: swelling itchiness, and warm to the touch; Swelling,... Read more
dizziness; injections site reactions including: swelling itchiness, and warm to the touch; Swelling, itchy, hot to touch at injection site; injections site reactions including: swelling itchiness, and warm to the touch; fever of 103 at highest; her eyes hurt; weak; lethargic; headache; slight aches/Achy/whole body hurt; skin was sensitive; she felt like she had the flu; felt very sick; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via intramuscularly in left arm on 29Jan2021 at 10:50 am as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246), via intramuscularly in left arm on 08Jan2021 at 10:50 am as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 30Jan2021 at 00:00, patient experienced achy, weak, headache, eyes hurt, lethargic, whole body hurt, fever of 103 at highest. She also said on Saturday around 12:00 am, is when she felt very sick, her skin was sensitive. It was reported that Today, she still feels slightly dizzy, has a headache and slight aches. Patient also experienced dizziness. Sunday, her temperature went down to 99.2 degrees Fahrenheit. On 31Jan2021 at 07:00, patient experienced Swelling, itchy, hot to touch at injection site. She stated she doesn't typically have reactions to vaccines, and that symptoms are improving from peaking on Saturday 30Jan2021. She's wanting to know if these are normal and how long AEs might last. Today she still feels dizzy, has HA and slight aches. No duration is reported for other AE's. Referred to MD for treatment. She wanted to know if it was normal not to feel right after having the shot on Friday. She is a dental hygienist. She provided her weight as being between 145-150. NO ER or physician's office required. Patient medical history was reported as provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was reported as none. The outcome of the event dizziness, felt very sick, felt like she had the flu, skin was sensitive was unknown and outcome of the events injections site reactions including: swelling itchiness, and warm to the touch was not recovered and outcome of the other events was recovering. Follow-up attempts are completed. No further information is expected.
42 2021-05-31 numbness, tingling, pain in extremity Within 2 minutes of receiving shot had pain numbness and tingling in the right arm. By 415 that afte... Read more
Within 2 minutes of receiving shot had pain numbness and tingling in the right arm. By 415 that afternoon broke out in hives and felt itchy all over, felt very tired and achy and had a heaviness in my chest and started having episodes of dizziness that are on and off
42 2021-05-31 pain in extremity Patient complaining of lower leg pain specifically to a particular vein in left lower leg.
42 2021-05-31 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
42 2021-06-01 numbness Left sided facial numbness within 2 hours of 2nd dose of vaccine
42 2021-06-02 burning sensation a rash appeared on my half of my face from left chin to upper right forehead.; Rash is itchy and bur... Read more
a rash appeared on my half of my face from left chin to upper right forehead.; Rash is itchy and burns; Rash is itchy and burns; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old non-pregnant adult female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Left arm on 04Mar2021 at 14:15 as First Dose, Single for COVID-19 immunization. The patient medical history not reported. There were no concomitant medications.The patient previously took pitocin [oxytocin] and experienced drug hypersensitivity. The patient did not take any other medications within two weeks of vaccination and no other vaccine within 4 weeks of vaccination. After about 4 hours of the vaccine administration On 04Mar2021,at 19:00,the patient reported a rash appeared on my half of my face from left chin to upper right forehead, rash is itchy and burns. Therapeutic measures were taken as a result of a rash appeared on my half of my face from left chin to upper right forehead, rash is itchy and burns. I have been applying Sarna cream and ice packs. The outcome for the events was recovering. No follow-up attempts are possible. No further information is expected.
42 2021-06-02 feeling cold, pain in extremity She got her vaccine, she had a sore arm, but otherwise had no reaction. The next morning at 10:00 ... Read more
She got her vaccine, she had a sore arm, but otherwise had no reaction. The next morning at 10:00 AM she felt extremely tired as if she had not slept in days. Then she got extremely cold and had to wrap up with a blanket. She started making lunch for the children, and had made chicken nuggets for one of them, and the smell made her extremely nauseous and was throwing up 4 different times, and felt like she had morning sickness. She had to call the parents to pick up the children, and went to bed at 4:00 PM yesterday and woke up at 6:00 AM this morning. She has extremely aching of joints, low back in the waist area. She had a temp of 100.0, and when she took it this morning it was 97.9. She did not eat yesterday, and the smells again have given her dry heaves and has not eaten anything since the vaccine. She is still having the nausea and the queasy feeling, as well as back aches. She has been taking OTC Motrin for the symptoms.
42 2021-06-02 numbness, tingling, pain in extremity Within 10 minutes following the shot, elevated heartrate 30-40BPM above normal resting HR. Elevated ... Read more
Within 10 minutes following the shot, elevated heartrate 30-40BPM above normal resting HR. Elevated blood pressure well above normal range for patient. Normal BP, and BP at last doctor's visit 4/28/2021 was 97/70, and is usually around 100/60. BP within 15 minutes following vaccine was 122/80+. Within the next 24 hours patient experienced abdominal pain, diarrhea, sore arm, headache, extreme fatigue, body aches. Over the next week following the vaccine patient experienced headaches, fatigue, body aches and abdominal pain/nausea every day. 14 days later, patient is still experience headaches, fatigue, body aches daily. And in the past 5 days, patient has started experiencing numbness/tingling in both arms from shoulder to tip of pinky. On 6/3/2021 (date of filing this report), patient has experienced numbness and tingling in both arms all afternoon into the evening at the time of filing this report. Regarding daily headaches since the first dose, patient never experiences headaches unless there is a problem or illness. Patient now experiences headaches every day. Patient has been messaging primary care physician about these symptoms and messaged one of her specialists about these symptoms on 6/3/2021.
42 2021-06-02 numbness, tingling Tingling & numbness in left leg, right foot, left forearm 10 minutes after vaccine that persisted fo... Read more
Tingling & numbness in left leg, right foot, left forearm 10 minutes after vaccine that persisted for 12-14 hours. Prednisone was taken when symptoms did not subside after 2 hours. Some mild aches still persist 4 days later.
42 2021-06-02 migraine Severe migraine headache; 10 minutes after taking vaccine experienced itching in right ear; Itching ... Read more
Severe migraine headache; 10 minutes after taking vaccine experienced itching in right ear; Itching in throat; blood pressure was 156; throat was swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 42-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN), via an unspecified route of administration on the right arm on 14Mar2021 at 15:30 pm (at the age of 42-years-old) as single dose for COVID-19 immunisation. Medical history included allergy, asthma and pre diabetes, the patient was allergic to baby aspirin, peanut and pecans. Concomitant medications included ZYRTEC, SYMBICORT and azelastine (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 14Mar2021 at 15:45 pm, 10 minutes after the vaccination, the patient experienced itching in right ear and throat which lasted for 40 minutes. On the same day, patient blood pressure was 156 (unit not specified) and five hours later the patient throat was swollen, which went after sometime. On 15Mar2021 at 3.30 am (12 hours after shot), the patient had severe migraine headache which lasted for 36 hours. No treatment was received for the reported events. The clinical outcome of the event blood pressure abnormal was unknown and for event throat swelling it was reported as recovered on 14Mar2021. The outcome of the event itching in right ear was recovered on 14Mar2021 at 16:25 and for event migraine, it was recovered on 16Mar2021 at 15:30. Information about lot number cannot be obtained. No further information expected.
42 2021-06-02 pain in extremity Soreness in left arm; This is a spontaneous report from a contactable consumer (patient herself). A ... Read more
Soreness in left arm; This is a spontaneous report from a contactable consumer (patient herself). A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry date not reported) via an unspecified route of administration in Arm Left on 06Mar2021 at 13:30 as 1st dose, single dose for COVID-19 immunisation. The patient was pregnant. The patient's medical history was none. There were no known allergies. The patient's concomitant medication(s) included montelukast taken for an unspecified indication, azelastine taken for an unspecified indication, ethinylestradiol, norgestimate (ESTARYLLA) taken for an unspecified indication and ‘Doterra Oils' taken for unspecified indication. No other vaccine in four weeks. No COVID prior vaccination and not tested COVID post vaccination. On 06Mar2021 at 19:00, the patient experienced soreness in left arm. Therapeutic measures were not taken as a result of adverse event. It was reported that lot was not reported as unable to locate or read the details. The outcome of the event was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
42 2021-06-02 tingling, pain in extremity Fever; chills; severe headache; fatigue; swollen lymph nodes; sore throat; body aches; LARGE, INFLAM... Read more
Fever; chills; severe headache; fatigue; swollen lymph nodes; sore throat; body aches; LARGE, INFLAMED, RED MASS 1-2 INCHES BELOW INJECTION SITE. Extreme and sustained pain and swelling of the arm. Hot to the touch. Tingling from jawline on left side of face to fingertips of left hand persists after 50+ hours post-injection. Swelling on arm is approximately 6 inches in diameter. The red, concentrated area is approximately 3 inches wide by 2 inches high at the center of the swelling.
42 2021-06-02 tingling hands were tingling; her heart was racing; This is a spontaneous report from a contactable consumer ... Read more
hands were tingling; her heart was racing; This is a spontaneous report from a contactable consumer (mother). A 42-years-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tingling in hands and her heart was racing on an unspecified date. Outcome of the events was unknown. Information on the lot/batch number has been requested.
42 2021-06-03 migraine 101.3 degree fever, chills, sweating, nausea, vomiting, diarrhea, swollen lymph nodes, axillary lymp... Read more
101.3 degree fever, chills, sweating, nausea, vomiting, diarrhea, swollen lymph nodes, axillary lymph node pain, migraine, photophobia, lack of appetite, fatigue, malaise
42 2021-06-03 migraine Tired feeling; Joint pain; Vomiting; Shaky feeling; Migraine; Stiff neck; Slight headache; This is a... Read more
Tired feeling; Joint pain; Vomiting; Shaky feeling; Migraine; Stiff neck; Slight headache; This is a spontaneous report received from a contactable healthcare professional, the patient. A 42-year-old non pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the left arm on 17Mar2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, hypothyroidism, tension headache (on 16Mar2021) and allergic to mold. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included SYNTHROID, ZYRTEC and MIDNITES, all for an unspecified indication, initiated on unknown date. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient previously took aspirin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, immediately after the vaccination, the patient experienced a bit of a stiff neck and still had a slight headache. Over the course of about 5 hours at 19:00, the headache turned into a migraine with splitting head pain, shaky feeling and vomiting. The patient was self-treated with two TYLENOL rapid release, but only managed to throw them back up. She went to sleep and by about midnight she was feeling mostly better, with only a slight headache and tired feeling lingering. She felt fatigued and had some minor joint pain at the time of the report. The clinical outcome of the events stiff neck, migraine, vomiting and shaky feelings were recovering; tired and headache was not recovered and the outcome of joint pain was unknown. No follow-up attempts are needed. No further information is expected.
42 2021-06-03 pain in extremity Chills; Low grade fever; Shoulder pain; left arm pain; back pain; swollen lymph node in left axillar... Read more
Chills; Low grade fever; Shoulder pain; left arm pain; back pain; swollen lymph node in left axillary area; fatigue; headache; This is a spontaneous report from a contactable pharmacist, the patient. A 42-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 15Mar2021 at 11:15 hours (at the age of 42-years) as a single dose for COVID-19 immunisation. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 22Feb2021 at 11:15 hours as a single dose for COVID-19 immunisation. The patients medical history included hypertension. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN) 12.5 (unit unspecified) once daily (QD). The patient received this medication within 2 weeks of vaccination and exact therapy dates and indication for it was not reported. On 16Mar2021, the patient experienced chills, low grade fever, shoulder pain, left arm pain, back pain, swollen lymph node in left axillary area, fatigue and headache. The patient received Motrin as a treatment medication. On an unknown date in Mar2021, the patient was recovered from the events chills, low grade fever, shoulder pain, left arm pain, back pain, swollen lymph node in left axillary area, fatigue and headache. No follow up attempts are needed. No further information is expected.
42 2021-06-03 pain in extremity Pt c/o pain in the Left Arm. BP 108/73, HR 84. Pt stable and released from the vaccination site.
42 2021-06-05 mild one side paralysis Event - stroke without known precursors Treatment- currently in inpatient rehab Outcome - unknown if... Read more
Event - stroke without known precursors Treatment- currently in inpatient rehab Outcome - unknown if I will regain full use of right side 3 days at hospital and now currently in inpatient rehab with unknown discharge date
42 2021-06-06 muscle twitching, numbness Twitching of upper left arm Twitching of left abdominal side Fever and swelling of clavicle bone on ... Read more
Twitching of upper left arm Twitching of left abdominal side Fever and swelling of clavicle bone on left side, protruding, tender and with fever Passing face numbing others maybe more expected: fatigue/soreness for about 1-2 days after the shot was given.
42 2021-06-07 burning sensation This is a spontaneous report from a contactable other health care professional reported that. A 42-y... Read more
This is a spontaneous report from a contactable other health care professional reported that. A 42-years-old non-pregnant female patient received dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Left Arm on 04Mar2021 at 11:15 (at the age of 42-years old) as single dose for COVID-19 immunization. The Medical history included none. The patient's concomitant medications were not reported. The patient previously took Levaquin (Levocetirizine) and experienced allergy. The patient has not suffered from COVID-19 prior vaccination. The patient had not done COVID tested post vaccination. Patient has not received other vaccine in four weeks. 2 days after 1st dose, on 06Mar2021 at 06:00 AM, the patient reported my skin was very itchy, mostly around chest, neck and face, but day 3 the itchy sensation turned into a slight itchy burning sensation in same areas of body, took a Benadryl and it went away, by day 4, same burning sensation but now in hands and arms, went to Dr and he told, had some hives. The patient received treatment for the events. Prescribed Levocetirizine 5g for a week and also advised to take OTC Zyrtec after week daily for allergies. Patient do not suffer from allergies nor have ever had a reaction to a vaccine before. The outcome for the events skin was very itchy, mostly around chest, neck and face, but day 3 the itchy sensation turned into a slight itchy burning sensation in same areas of body, sensation but now in hands and arms, hives were recovering. No follow-up attempts are possible. No further information is expected.
42 2021-06-07 pain in extremity Soreness and stiffness of arm and under arm extending down the left side more persistent on Sunda... Read more
Soreness and stiffness of arm and under arm extending down the left side more persistent on Sunday June 6, 2021. Rash noted at injection site on Monday June 7, 2021, itching of injection site on Tuesday June 8, at approximately 2:30 am
42 2021-06-08 weakness, cold sweat, numbness, migraine This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient ... Read more
This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiration date: unknown), via intramuscular route, administered in upper left arm on 19Mar2021 (at the age of 42-year-old) as 1st dose, single dose for COVID-19 immunisation. She was given vaccine between 15:00 pm and 16:00 pm. The patient medical history includes asthma, gastroesophageal reflux disease, covid -19 and migraine. Concomitant medications included Breo, Singulair, Flonase and Azelastine. The hospital advised to stop taking Flonase. She had rabies vaccine for work, and she must be checked every 2 years for titers. There was no family history. She was not HIV positive or syphilis positive. The patient experienced within 15 minutes of receiving the vaccine, her left side of face went numb, and the left arm went heavy. By the next day, the thumb and pinky on left hand were numb and had pain in left arm pit. The patient experienced migraines on 18May2021. The inside of her mouth has been persisting on left side of face. The rest of her face was getting better, but then 2 weeks ago she had another full episode, and it went back numb again on the left side of her face and has been numb since. Now it has traveled into left eye up towards the eyebrow, towards her ear, down to her chin, and straight up the middle. Half of her tongue feels tingly numb, and the other half was fine. Her lips are numb. It was like when you get dental work, get home, and the Novocaine wears off. And that was what the whole left side of her face feels like. Did not feel as heavy as the first couple of days, but she feels like she cannot use her arm because it was weak. Left thumb and pinky were numb was on and off. Since she relapsed 2 weeks ago, it has been numb ever since. The left-hand grip was weak. Numbness of left thumb and pinky has gotten worse. Her left-hand grip has gradually worsened as time has went on. She had pain every once in a while, but pain was not constant like it was. She was been having headaches since she got Covid. Asthma, reflux, and Covid that should be all of her medical conditions. The patient saw on a group to call this number if she had a reaction to the Pfizer vaccine. She did VAERS online reporting back in Mar. She states people are like they never heard of what happened to her before. The patient was 216 or 218 pounds. She had been waiting since Mar since the adverse reaction. She stated it takes about a month to get her fully on the medication. She just started on medications and was told it will take about 2-3 months before she starts feeling better if medications works. She saw EMTs at site and told her if face was still numb next day to go to the ER. She woke up and more of her face was numb, pinky and thumb were numb, and her arm pit was hurting. She went to the ER on 20Mar2021. She was discharged the next day on 21Mar2021 with no diagnosis and told to follow-up with neurologist. On 11May2021 while at work, she had a weird feeling come over her body. She went clammy and was weak, she could barely stand. The numbing of the face was just in her mouth but that night, her whole face went numb on left side. She could barely walk; it was super weird. They did head CT, cervical CT, and bloodwork, but they could not really find anything. She was admitted back into the hospital on 12May2021, and they did more brain MRIs and bloodwork. She was discharged on 14 May with really no diagnosis and to follow-up with the neurologist. Lab test included Covid negative on 13Jan2021 and 4 brain MRIs. Two were regular MRIs, a brain MRI with contrast, and she thinks it was a MRA where they looked at the blood vessels flow in and out of the brain. She also had brain CT, cervical spine CT, and a ton of blood work. She was hospitalized twice. And they still do not know what was wrong with her. She will 2 more brain MRIs and a cervical MRI left to go in 2 more weeks, Covid 19 Test (positive in Dec2020 and negative in 13Jan2021). The outcome of the events left side face went numb and left thumb and pinkie numbness was not recovered/resolved. Left arm heaviness and axillary pain was recovering /resolving. The outcome of feeling abnormal, difficulty in standing, Tingling tongue, Numb lips, migraine, cold sweat(clammy) and asthenia was unknown. Information on Lot/Batch number was available. Additional information has been requested.
42 2021-06-08 pain in extremity it was a pain in the butt; fever; arm just hurts.; This is a spontaneous report from a contactable c... Read more
it was a pain in the butt; fever; arm just hurts.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Lot number: EW0170) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient asked how long my fever was going to last and I got the shot yesterday. It was only 99.5 and took Tylenol, she felt ok, except her arm just hurts and it was a pain in the butt. the patient wanted to know how long a fever last after your second shot. The patient underwent lab tests which included body temperature resulted as 99.5 Fahrenheit on an unspecified date. The clinical outcome of the events was unknown. Information about batch/lot number has been requested.
42 2021-06-08 pain in extremity I was breathless and extremely exhausted for several weeks prior to the most extreme symptoms presen... Read more
I was breathless and extremely exhausted for several weeks prior to the most extreme symptoms presented. I started feeling excruciating chest pain so much so that I thought I was having a heart attack, could not sleep at night because the pain grew increasingly worse, radiating pain down my arms, and it was extremely difficult to even complete sentences I was so winded. As these symptoms progressed I thought they were an injury from yard work and wrote it off as costochondritis and suffered. Eventually I was at work and could not even get a sentence out without extreme pain and breathlessness. I was taken to urgent care where they instructed me to go to the emergency room at hospital. There I was given a series of tests. I believe I had a echocardiogram where all my findings were normal. Then they did a blood test where they look for clotting as they were concerned about a blood clot. That was a slightly elevated number which then brought me to a CT scan with contrast. This is where they found that it was not a blood clot but pericarditis. They followed up with a ultrasound of my heart where they saw the sack around my heart inflamed with fluid. The first question I asked the doctor is could this be related to my vaccine which I just completed. The more I learned about pericarditis, the longer I realize how long I have been suffering with breathlessness. I dismissed it for such a long time because I had recently had another baby and was doing a lot of heavy lifting carrying her around as well as mask wearing as a teacher. Because of the mask I dismiss my breathlessness and ignored it for a long time.
42 2021-06-09 numbness, pain in extremity sore arm; both arms go numb all the way to pinky, heavy feeling that she can't describe in any other... Read more
sore arm; both arms go numb all the way to pinky, heavy feeling that she can't describe in any other way; headache; nausea; stomach pain; dark circles under her eyes; heart rate was elevated; so foggy the first day; diarrhea; extreme fatugue; both arms go numb all the way to pinky, heavy feeling that she can't describe in any other way; This is a spontaneous report from a contactable consumer (patient) or other non hcp from an Agent Team. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for Injection, Batch/Lot Number: EW0177) via an unspecified route of administration, administered in arm left on 20May2021 08:57 (at the age of 42-year-old) as 1st dose, single dose for covid-19 immunisation. Medical history included vasovagal syncope (Verbatim: vasovagal syncope), overheated, fearful, or not feeling well, she faints. Caller states if she has an illness, she will throw up and pass out. Reporter states when she faints, she stops breathing. The patient's concomitant medications were not reported. Patient previously took vaccine included Titanus (she got was 11 years ago and that was the tetanus DDAP or TDAP). On an unspecified date the patient experienced sore arm, on 20May2021 the patient experienced extreme fatigue, both arms go numb all the way to pinky, heavy feeling that she can't describe in any other way, diarrhea, heart rate was elevated, so foggy the first day, on 21May2021 the patient experienced headache, nausea, stomach pain, dark circles under her eyes, on an unspecified date in Jun2021 the patient experienced both arms go numb all the way to pinky, heavy feeling that she can't describe in any other way. patient having symptoms from the Covid vaccine that she got about 14 days ago and she's due for her second dose Thursday. Transferring agent states the caller doesn't want to, s patient having concerns that patient going to experience the same thing patient having if she gets the second dose and if she is, patient doesn't want to go through with the second dose. Patient states basically 14 days after having the first dose, which patient had on 20May2021 at 0850. patient states she still having some side effects 14 days later and from asking around and reading up, most people aren't still having side effects 14 days later. Patient states she was concerned about whether she should get the second dose or not. she can't take SSRIs, NSAIDS, can't have caffeine. Patient states she been having headaches every single day since the first dose. she was extremely fatigued. Patient states starting a few days ago, her arms go numb. Patient states yesterday they were numb all afternoon into the evening, there was nothing she could do, she tried to stretch and move each arm. Patient states her pinky's are numb on each hand, which is new, that's never happened before. Patient states just based on all that, she did have some pretty strong symptoms for the first 48 hours after vaccine. Patient states within first 15 minutes, her heart rate was elevated her normal resting heart rate is in the 50s and 60s and even some-times at night while she's sleeping, it goes into the 40s and after the vaccine it went up to the 90s. Patient states her blood pressure last time at the doctor was 97/60. Caller states her blood pressure is usually really low. Patient took her blood pressure 15 minutes after the first dose, she thinks it was 122/80 something, which is normal for most people, but for her its really high. Patient states her cardiologist said she had a little bit of inflammation and said to check with her primary care provider so she messaged her all that information but her primary care doctor is supposed to be leaving for her vacation, so she might not have a chance to look at it. the first 48 hours, she felt incredibly heavy, she could get up and walk around, she just didn't feel right. Patient states anytime her significant other went over a bump in the car on the way home, she just doesn't know how to describe it, it wasn't motion sickness, she thought oh my gosh don't go over anymore bumps, it intensified the heavy feeling. Patient states had nausea and stomach pain but that's mostly gone away now. she also had diarrhea for the first 24 hours. Patient states other family members who had Moderna were very sick after their second dose. Patient states there was a report that came out. Patient states her daughter and significant other also got their first dose and her daughter is 13, they had no reaction other than a sore arm and a little fatigue the first day. Headache: Patient states she had a headache within 24 hours, it's more of an after effect, definitely a lingering one. Caller states it's not constant, they come and go but for someone who never usually gets headaches unless severely ill is weird. Fatigue: Patient states fatigue started that day, 20May2021, it was definitely worse the first several days after, and hasn't completely gotten better, its still lingering. Patient states she thinks its improved, she's trying to exercise more. Caller states the days she does exercise, she feels less fatigued. Patient states she has been exercising more since 01Jun2021. Arms go numb; pinkies are numb on each hand: the numbness started within the last few days. Patient states it's from her scapula down to her pinky, its weird. Heaving feeling: Patient states she got a heavy feeling within 5 or 10 minutes of getting the shot then it kind of worsened through out the day, it was weird. Patient states she would get to the point where she needs to lay down but if she laid down for a long time she would feel worse and then she would start moving around but then if she kept doing stuff she would get to the point where she had to lay down again. Diarrhea began right after shot when she got home within an hour and it was just the next 24 hours. Nausea; stomach pain, the nausea and stomach pain lingered. she does have to follow a GERD diet to prevent stomach ulcers so when she sticks to that she doesn't have any stomach pain but if she has a tomato or onion here or there it will start to come back. she was so foggy the first day. dark circles, she had been sleeping up to 8 hours a night and before she was only sleeping 6 hours a night so she would think it wouldn't be that way. Went with Pfizer because a family member had zero reaction to either dose whereas those who took Moderna were very sick after the second. The immediate members of Patient household were completely fine after their first Pfizer dose. patient underwent lab tests and procedures which included blood pressure measurement: 122/80 (122/80 something), heart rate: 90 on 20May2021.The outcome of the event headache was not resolved, outcome of the event extreme fatigue, both arms go numb all the way to pinky, heavy feeling that she can't describe in any other way, heart rate was elevated, so foggy the first day, sore arm was unknown, outcome of the event nausea, stomach pain, dark circles under her eyes was resolving, outcome of the event both arms go numb all the way to pinky, heavy feeling that she can't describe in any other way was resolved on an unspecified date in 2021, outcome of the event diarrhea was resolved on 22May2021.
42 2021-06-09 pain in extremity Patient received 2nd dose of Pfizer vaccine on the 14th day after the first dose. 1st dose given on ... Read more
Patient received 2nd dose of Pfizer vaccine on the 14th day after the first dose. 1st dose given on May 13th 2021 2nd dose given on May 27th 2021 reported having the following symptoms after the 2nd vaccine; soreness of arm, fatigue, slight shortness of breath per patient yesterday.
42 2021-06-09 tingling, numbness, pain in extremity MY ARM WAS SORE AT THE INJECTION SITE IMMEDIATELY AFTER MEDICINE INJECTED. MY ARM HAS CONTINUED OVE... Read more
MY ARM WAS SORE AT THE INJECTION SITE IMMEDIATELY AFTER MEDICINE INJECTED. MY ARM HAS CONTINUED OVER THE LAST MONTH TO GET WORSE WITH THE PAIN RADIATING DOWN THE ARM AND CAUSING MY HAND TO GO NUMB AND TINGLING AT TIMES.
42 2021-06-10 discomfort So on 2/23/2021 I have hives at 1:30AM and took Clariton. 3AM tongue was still itchy. I woke up unco... Read more
So on 2/23/2021 I have hives at 1:30AM and took Clariton. 3AM tongue was still itchy. I woke up uncomfortable both times. I went to the DR 2/23/2021, just took Benadryl. On 3/12/2021 in the evening I had my eyes and tongue swollen at about 9PM. I have consistently had intermittent swelling on m tongue. I have been seen by an allergist as well on May 27th , I had a skin prick test and allergy tests. I now have to carry Benadryl, steroid pills and an EpiPen wherever I go. There was tongue on 2/23/2021 that was really bad, I did not have eye swelling or anything like that. Starting 2/24/2021 I was on steroids and 2x a day Benadryl but none of that really alleviated the swelling either.
42 2021-06-10 feeling jittery fever, fatigue, jittery day 1-day 3, Day 4-7 developed measles-like (morbilliform) rash from hip to... Read more
fever, fatigue, jittery day 1-day 3, Day 4-7 developed measles-like (morbilliform) rash from hip to hip on lower abdomen, traveling up up below breast. New spots appeared daily.
42 2021-06-10 hot flush Stopped having menstrual cycles. Hot flashes x few weeks. Now has fragmented sleep, mood lability,... Read more
Stopped having menstrual cycles. Hot flashes x few weeks. Now has fragmented sleep, mood lability, weight gain (8 pounds in 1 month). Labs suggest mesopause.
42 2021-06-10 tremor Approximately 2 days after the vaccine, I started experiencing shortness of breath, fatigue, profoun... Read more
Approximately 2 days after the vaccine, I started experiencing shortness of breath, fatigue, profound muscle weakness in my lower legs and lower arms, and tremors. The symptoms got worse over the next 3-4 days and then started to gradually lessen. I'm now 2+ weeks post vaccine and I still have arm weakness and some leg weakness.
42 2021-06-11 numbness 42 y/o with medical history of Cervicalgia who presents with numbness to the right arm post vaccinat... Read more
42 y/o with medical history of Cervicalgia who presents with numbness to the right arm post vaccination. Patient states that this is the second dose in the two-dose Pfizer series. Patient states that after the first vaccination with similar complaints that only lasted a few minutes. Patient states that vaccination was received to the right arm. Patient denies headache, vision changes, neck pain, facial numbness, sore throat or difficulty breathing, chest pain. Patient evaluated by the NP and Paramedics. Patient initial BP was elevated 153/93 but subsequent bps normal (126/85). All other vitals within normal limits (97-98% SPO2, 78-80 HR). Patient with improvement of symptoms within 15 mins post observation. Patient advised that Tylenol has be taken if any pain to injection site or discomfort to R arm. Patient aware of symptoms persist or worsen to please seek medical attention, patient verbalized understanding. Patient discharged in stable condition with her father.
42 2021-06-14 breast pain, tenderness I started having pain under my right arm in the armpit area and my right breast as well. It is not c... Read more
I started having pain under my right arm in the armpit area and my right breast as well. It is not completely gone yet. I had a mammogram done that showed swollen lymph nodes in the affected area. A fibroadenoma mass that was biopsied by the doctor. I saw an ob/gyn that referred me to have a mammogram and diagnostic ultrasound. The breast surgeon noted the mass and the swollen nodes. The biopsy came back benign. I have another mammogram scheduled in the near future. The pain has decreased but it is still tender and swollen. The doctor said depending on how things progress, the mass could either get removed or remain under observation.
42 2021-06-15 cold sweat Headache; Feeling lightheaded/dizziness; nauseated; Sweating; Became pale; Clammy; This is a spontan... Read more
Headache; Feeling lightheaded/dizziness; nauseated; Sweating; Became pale; Clammy; This is a spontaneous report from a contactable nurse. A 42-year-old non-pregnant female patient received bnt162b2 (COVID-19 Pfizer/BioNTech vaccine, Batch/Lot Number: EN6204), dose 2 via an unspecified route of administration on 15Mar2021 01:35 PM (at the age of 42 years old) as single dose for covid-19 immunization. The patient previously received bnt162b2 (Lot Number: EL9265), dose 1 on unknown date for as single dose for covid-19 immunization. Medical history included kidney stones, patient only had one kidney (left kidney). No illness at time of vaccination or up to 1 month prior. Concomitant medications included ascorbic acid (VITAMINS C) and vitamin d nos. On 15Mar2021, patient reported to vaccination site for second dose of Pfizer/BioNTech vaccine, received vaccine at approximately 1:34 PM. Approximately 1:48 PM patient reported feeling lightheaded and nauseated. The patient also experienced sweating, became pale, and clammy. At 2:20 pm, patient transported by emergency medical service (EMS). EMS arrived at 2:28 PM, and departed at 2:35 PM. Patient status on departure: 2:35 pm patient alert on oriented reporting dizziness, headache, nausea. Vitals taken as, 1:50 PM: 139/99, HR80, resp 16, O2 96%; 01:55PM: 146/99, HR84, resp 18, O2 97%; 02:00 PM: 145/88, HR85, resp 18, O2 98%; 02:05 PM: 139/89, HR61, resp 18, O2 98%; 02:10 PM: 134/89, HR71, resp 18, O2 99 %; 02:15 PM: 135/82, HR75, O2 96%; 02:20 PM: 131/87, HR70, O2 99%; 02:28 PM: 130/76, HR69, O2 99%. Body temperature was 97.9. No oxygen started and no CPR Indicated. The outcome of events was unknown. Follow-up attempts completed. No further information expected.
42 2021-06-16 discomfort The next day after the vaccination at 3:00 PM, I felt bone pain, tiredness, with a fever and that la... Read more
The next day after the vaccination at 3:00 PM, I felt bone pain, tiredness, with a fever and that lasted all afternoon until Sunday. On the same Sunday at 12 noon I started with a stomach ache (similar to some contractions) I went to the bathroom 4 times solid and then on the 5th excretion I saw blood and I thought it was menstruation, from then on I had 11 bloody stools; I was in a lot of pain. He had no appetite. Monday morning to the hospital (at 7AM) and I explained everything to them and they did several tests, they gave me medicine for the pain and the discomfort went away, and they discharged me. I was 8 days with treatment.
42 2021-06-16 pain in extremity blood pressure was high; Arm was really sore; feeling sick; vomiting; diarrhea; This is a spontaneou... Read more
blood pressure was high; Arm was really sore; feeling sick; vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158; Expiration date: Jul2021; NDC number: 59267-1000-02), via an unspecified route of administration in right arm on 12Apr2021 (at the age of 42-year-old) as single dose for COVID-19 immunization. Medical history of the patient included ongoing hypertension (from 2020), ongoing acid reflux (from an unspecified date), allergies (unspecified) and stomach problems. Family medical history of the patient included high blood pressure and diabetes. Concomitant medication included Diphenhydramine 25 mg once daily (started in Apr2021 and ongoing) for allergies, Womens Vaginal and Digestive Health Probiotic (started in Apr2021) for stomach problems and multivitamin one tablet once daily (started in Apr2021) to keep up with her health as patient was in her 40s. Patient previously took Amlodipine Besilate/Telmisartan (expiration date: 31Dec2022) in 2020 and stopped the medication because her blood pressure went down. Patient reported that she had not taken the amlodipine/telmisartan at all previously in 2021, but her blood pressure was high this week, so amlodipine/telmisartan was started again in in May2021. Patient previously received flu vaccine (unspecified) on an unspecified date for immunization and did not get sick. Patient stated that she does not usually get sick with vaccinations. On 12Apr2021, patient's arm was really sore, patient had to sit and wait after receiving the first dose of vaccination, and by the time she got home her arm was progressively getting sore and tender. Patient reported that her arm hurt the rest of the week into the weekend. In Apr2021 (two days later after first dose of vaccination), patient was feeling sick when she woke up and experienced a little vomiting and diarrhea. Patient was really sick for a few hours with vomiting and diarrhea. Next day, when patient woke up her stomach had settled. Reportedly, as per patient she had a small reaction to the first dose of the COVID-19 vaccine where she experienced a little vomiting and diarrhea on the third day and reported that the vomiting and diarrhea passed. Patient did not report the vomiting and diarrhea because vaccine information had said that about the third day after the vaccine, patients would get a little sick and the caller thought it was normal. Events arm was really sore, little diarrhea and vomiting resolved in Apr2021 while outcome of event feeling sick was unknown and blood pressure was high as unknown. Investigation Assessment: No No follow-up attempts are needed. No further information is expected.
42 2021-06-17 discomfort Fever; Back pain; Sick; like the flu, a bad flu; could not get up; body looked like somebody hit her... Read more
Fever; Back pain; Sick; like the flu, a bad flu; could not get up; body looked like somebody hit her, like she had a crash , had body pain; body was very heavy; She now has her period.; This is spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a 42-year-old female patient received second dose of BNT162B2 (Pfizer Covid 19 vaccine, Solution for Injection, Batch/lot number: ER8729, Expiration date: Unknown), via an unspecified route on right shoulder on 13Apr2021 at around 16:00, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Pfizer Covid 19 vaccine, Solution for Injection, LOT: ER8727, Expiration date: Unknown) on 23Mar2021 at around 16:00, on right shoulder, as a single dose for covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Family history included diabetes (mother) and high cholesterol (husband) and prostate cancer (Father-in-law). She received the vaccine at like 2:00pm or 3:00pm. Initially reported as around 2:00 or 3:00pm; but when time of administration later queried reported she thinks they were both at the same time, like 3:00 or 4:00pm, thinks it was around 4:00pm By 9:00pm that day, her body looked like somebody hit her, like she had a crash on 13Apr2021. After the vaccine, she was sick for one day on 13Apr2021. She had a fever, and was like the flu, a bad flu on 14Apr2021 and she could not get up on 13Apr2021. Was like fever, body pain, and couldn't get up, she was very sick. After 24 hours, it was like nothing happened. On 13Apr2021, the back pain was a lot and on an unspecified date in 2021, her body was very heavy but had no headaches. She preferred being in bed. She had a fever at night, like at midnight. She didn't take any medicine. The next day, around 3:00pm, she took Tylenol and at about 7:00pm, it was like nothing happened, like she didn't receive the shot. It was very crazy. Like 24 hours after, she didn't feel anything. She thinks this was normal. The fever started in the middle of the night, around midnight, 3:00am. She does not remember she was in bed. The fever came and would go out and would come and go again. Was only for one night. On an unspecified date in 2021, She now has her period. The clinical outcome of the event was didn't feel anything after 24 hours (13Apr2021) and thinks this is normal, at about 19:00 on 14Apr2021 it was like nothing happened, like she didn't receive the shot, fever, she was sick, like the flu, a bad flu, body looked like somebody hit her, like she had a crash, had body pain was recovered on 14Apr2021 and events back pain, couldn't get up, body was very heavy, She now has her period was unknown. No follow-up attempts are possible. No further information is expected.
42 2021-06-17 numbness, tingling After I received the first dose, I almost immediately felt pain in my elbow. It happened when I was... Read more
After I received the first dose, I almost immediately felt pain in my elbow. It happened when I was waiting 15 minutes. I didn't say anything because I was told that my arm would most likely be very sore, so I thought it was just that. There wasn't pain at the injection site, but only concentrated in my elbow. I can only describe it as if you whack your elbow into a corner of a wall and you get that pain/tingly funny bone sensation. It's painful, a little numb and sometimes even difficult to extend and bend my arm at the elbow joint. And sometimes difficult to grip my left hand. After about 2 weeks of having this pain, I realized that my 2nd shot was coming up. I thought it was weird that I still had pain but so many people had told me about sore arms, I didn't think much of it at the time. So I tried calling my doctor, however I found that she had left the practice and I couldn't get in to see anyone before my 2nd shot. I was told by that office to just go ahead and get the 2nd shot. I did 2nd on May 2nd and I explained to the nurse there what had happened and she did the shot in my right arm, and I have had zero issues. She advised me to see a doctor about my left arm and thought it could be nerve damage. Since I no longer had a doctor, I had to find a new practice and I have an appointment next week to talk to them about this. I couldn't reach anyone at the vaccine clinic and was only told to "see my doctor". I wish there was better direct follow up with all of these mass vaccine clinics
42 2021-06-17 tingling, numbness tingling sensation on the left side of my body from face to feet, then it traveled toward my right s... Read more
tingling sensation on the left side of my body from face to feet, then it traveled toward my right side.; numbing sensation on the left side of my body from face to feet, then it traveled toward my right side.; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm on 18Mar2021 at 08:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included tourette syndrome from unknown duration. The patient had a known allergy to chamomile and penicillin. Concomitant medications included MENOPUR, GONAL F and CLOMID taking as fertility medication and were received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 18Mar2021, at 17:45, the patient experienced tingling and slight numbing sensation starting 10 hours after the first dose, on the left side of her body from face to feet, then it traveled toward the right side of her body. The patient did not receive any treatment for the events. The clinical outcome of the events tingling sensation and numbing sensation was not recovered. No follow-up attempts are needed. No further information is expected.
42 2021-06-17 tingling, pain in extremity, numbness It was painful tingling and numbness in my arm , legs and back pain. i still have the pain in my bod... Read more
It was painful tingling and numbness in my arm , legs and back pain. i still have the pain in my body
42 2021-06-19 numbness, burning sensation, nerve injury Shingles on the left side of the body, same side as vaccine injection. Numbness, systemic rash follo... Read more
Shingles on the left side of the body, same side as vaccine injection. Numbness, systemic rash following C8 and T1 dermatome. pain and burning, require emergency care and medications. Rash lasting for over three weeks and nerve damage and numbness in the carpal tunnel of left hand requiring further medical appointments and further medical attention. Apart from this most serious side effect, also experienced fainting and headaches as well as a discontinuance of my menstrual cycle during the initial injection. Subsequently a much shorter cycle the second one after injection of said vaccine.
42 2021-06-19 muscle twitching Facial twitching of upper lip and right cheek for approx 20 seconds.
42 2021-06-20 burning sensation, tingling I had a fever and body aches about 10 hours after injection but around 13 hours after vaccination, I... Read more
I had a fever and body aches about 10 hours after injection but around 13 hours after vaccination, I started having a severe burning sensation down my left arm and left leg. It subsided after about 30 minutes but I was left with paresthesia in my left arm and left leg. I occasionally have sharp nerve pains in my left calf and foot. My hand was slightly numb for the first two weeks after this occurrence but has since recovered. The paresthesia symptoms have not subsided. I am currently scheduled to see a neurologist.
42 2021-06-20 tingling, numbness dull pain all the way from shoulder to fingertips. Consistent aching on left side. tingling/numbness... Read more
dull pain all the way from shoulder to fingertips. Consistent aching on left side. tingling/numbness in arm and fingertips. Reports not having full function of strength in left hand, can't pick up a gallon of water. Pain is a 5/6 on a scale out of 10, comes and goes. Patient reports going to the ER and was referred to specialist.
42 2021-06-20 tremor I still have the rash and it is getting better. I have started to feel dizzy on the 13th-14th overni... Read more
I still have the rash and it is getting better. I have started to feel dizzy on the 13th-14th overnight. The morning of the 14th I fell, my husband stayed home and took me to doctors all week. The tremors did not start until the 18th. These are all new symptoms since I reported last.
42 2021-06-21 pain in extremity After 1st injection, mild chills, slight exhaustion 24-48hrs after, and diarrhea at 72hrs. About 1 w... Read more
After 1st injection, mild chills, slight exhaustion 24-48hrs after, and diarrhea at 72hrs. About 1 week later, hands/feet/joints started to hurt and feel tight and stiff. After 2nd injection, woken up with severe body pain the next morning lasted like that pretty much until 72 hours later when I also have nausea, vomiting and terrible headache. Those symptoms passed and I was left with very bad joint pain especially in my hands/arms up - joint pain and stiffness is starting to get better 3.5 weeks past 2nd injection.
42 2021-06-21 pain in extremity It started with sore arm, then 101 fever for 24 hours, plus joint pain, diareah on the third day, h... Read more
It started with sore arm, then 101 fever for 24 hours, plus joint pain, diareah on the third day, headache and pain and redness on vaccinations site. Numbness on the shot site On and off body aches for 4 days... still have sore body
42 2021-06-21 pain in extremity I woke up in middle of the night to go to the restroom I had pain in my arm and noticed I had a lump... Read more
I woke up in middle of the night to go to the restroom I had pain in my arm and noticed I had a lump the size of a golf ball. I saw rash on my areola going towards my armpit. The lump lasted about 2 weeks and the rash resolved in about 24 hours. I had my last period April 27th, I am currently 2 months past due with my menstrual cycle. My PCP ordered blood work and I've had two ultrasounds done to try and see what I haven't had a menstrual cycle. I also have pain in my lower right abdomen, I've had a test done to check my appendix, but they are fine.
42 2021-06-21 pain in extremity Headache, nausea, vomiting, chills, confusion. Lasted 6 hours. Headache lasted two weeks. Swelli... Read more
Headache, nausea, vomiting, chills, confusion. Lasted 6 hours. Headache lasted two weeks. Swelling around spine, neck, shoulders, is still on-going but getting better. I had loss of bowl control for a day. Headaches severe. Trouble sleeping still. Arm still sore.
42 2021-06-21 tingling -chest pain under left armpit immediately after shot 2. -elevated heart rate and BP after shot 1 pro... Read more
-chest pain under left armpit immediately after shot 2. -elevated heart rate and BP after shot 1 proceeding to get quite high to present day (148/90 at some readings). -pins and needles (tingling) in fingers starting around 6/11/2021 developing into full arm and leg tingling (hands and feet included) -chest pain under left armpit recurring as of 06/20/2021
42 2021-06-22 numbness Left arm numbness, tingling, can?t hold arm in a position for to long. Contacted dr for referral for... Read more
Left arm numbness, tingling, can?t hold arm in a position for to long. Contacted dr for referral for more testing. Still waiting to take test
42 2021-06-22 seizure Patient received Pfizer COVID-19 vaccine on 5/14/21 and 6/4/21 at pharmacy. On 6/16/21, patient was ... Read more
Patient received Pfizer COVID-19 vaccine on 5/14/21 and 6/4/21 at pharmacy. On 6/16/21, patient was admitted to Medical Center for seizure. Patient was found to have new left focal status epilepticus, right frontoparietal intraparenchymal hemorrhage and superior sagittal sinus thrombus. Patient underwent mechanical thrombectomy on 6/17/21 with partial recanalization. Patient is still admitted in the hospital as of 6/23/21.
42 2021-06-23 numbness NIGHT PHARMACIST WAS CALLED AT APPROXIMATELY 9:04PM BY PATIENT STATING "SEVERE NUMBNESS, FINGERS WER... Read more
NIGHT PHARMACIST WAS CALLED AT APPROXIMATELY 9:04PM BY PATIENT STATING "SEVERE NUMBNESS, FINGERS WERE BLACK AND PURPLE AND SWOLLEN". Pharmacist advised patient to go to ER to seek medical attention right away and to call pharmacy at their earliest convenience. Pharmacist left message for patient 6/19/21 as follow up, patient did not call back. At time of this report, have not heard from patient.
42 2021-06-23 tremor, numbness and pain in extremities Right after the vaccination, within 15 minutes, I was feeling dizzy. I went home I started having d... Read more
Right after the vaccination, within 15 minutes, I was feeling dizzy. I went home I started having difficulty breathing, hyperventilation, dizziness, nausea, severe headaches and anxiety. I used my pulse ox and my pulse rate was very high around 125-130. I also got tinnitus. The next day, I developed a tick in my hands and facial ticks. My hands were also very shaky. A week after I got the shot, I went to the doctor and my BP was 145/90. My BP is normally low because I have history of POTS. I had neuropathy in my extremities (hands and feet) , headache, dizziness, extreme brain fog, could not concentrate, anxiety, extreme fatigue, sleeping all the time, tinnitus, light sensitivity and mild arthritits in my hands. This seem to be my exacerbation of my prior lyme's disease symptoms and/or my autoimmune system. I had some IV fluids at the doctors office and was referred to a neurologist. All my doctors agree that the vaccine have triggered my autoimmune system to go into overdrive. It has taken me 2 months to recover and feel better again. I still have fatigue, tinnitus, and light sensitivity.
42 2021-06-24 pain in extremity, tingling I could not move my ring finger and my fifth finger, my pinky finger on my left hand at all; It felt... Read more
I could not move my ring finger and my fifth finger, my pinky finger on my left hand at all; It felt like someone stabbing me with a knife/The pain that I am experiencing is as well in my left side too; Sometimes its tingling, sometimes its like throbbing pain. Its like weird pain like on both hands. And like numbness pain, all these different kinds of pain; I have been waking up with like excruciating pain in my hand; I got pains in my joint where like I could barely bend my fingers and then the pain is like different; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration in left deltoid on 22Mar2021 as single dose and the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206, Expiry date: on an unspecified date in Jun2021), via an unspecified route of administration in left deltoid on 04Mar2021 as single dose for COVID-19 immunisation. Co-suspect medication included ongoing OCRELIZUMAB, on an unspecified date in 2017 as twice a year or every 6 months for multiple sclerosis. Stated that, she had been on different medicines. The patient's medical history included ongoing multiple sclerosis, on an unspecified date in Jan2002. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks. It was reported that, the patient was perfectly healthy, and she did not know why she was having these weird side effects. So, the patient wanted to report because she never had any pains. Stated that, the patient got her first dose of Pfizer Vaccine (further clarified as Pfizer COVID 19 Vaccine) on 04Mar2021 and the 2nd dose on 22Mar2021. Stated that, when probed whether the patient experienced side effects after the first shot or the second shot, the patient stated that, the thing was she did not know whether it had anything to do with the vaccine. She was just calling because she wanted to report. This did not start happening until might like 2 months later, like one and a half months later, might be 6 weeks later. Stated that, they did not write the expiration date for the 2nd dose. When probed whether the anatomical site was same for both shots, the patient stated that, the pain that she was experiencing was as well in her left side too. She did not think of that until now, but it was both in her left shoulder. Stated that, she was very healthy, but she did have an autoimmune disease. she had multiple sclerosis. So almost 3 months later and for the last couple of weeks, 4 to 5 weeks might be even a little longer, the patient had been waking up with like excruciating pain in her hand on 03May2021 at 5 o'clock in the morning. Stated that, the patient did not have arthritis, she was young and very healthy, she run marathon and she wanted to report this because someone that she knew also mentioned something that they had the side effects, and she could not find anything online about this. Stated that, when she had googled up issues that she was having with her hand, it leads to Rheumatoid Arthritis. Stated that, she never had COVID and she was like perfectly healthy. Stated that, she did not know whether people were experiencing issues with the vaccine a month later. Stated that, on 03May2021, the patient got pains in her joint where like she could barely bend her fingers and then the pain was like different. It was like all different kind of pain like today for instance, like she could not, it was the worst day. Stated that, on 13Jun2021, she could not move her ring finger and her fifth finger, her pinky finger on her left hand at and it felt like someone stabbing her with a knife and on 13Jun2021, sometimes it was tingling, sometimes it was like throbbing pain. Stated that, it was stiffness, and it was like weird pain on both hands and like numbness pain, all these different kinds of like anything that she could imagine related to some sort of pain was like she had not seen it. Stated that, she did not know what this was but she did not know whether it had anything to do with the vaccine because like she did not have arthritis. Stated that, she went to see a rheumatologist and they did all those tests on her and they were negative, blood tests. They did not really know what was wrong and she was like the only thing like change the last of the month was that she got the vaccine. Stated that, she did not want to point a finger and say like was it the vaccine but were there people that, she wanted to report this because it was weird, it was rare and she mean whether it was pain for a couple of days and also she got her second shot in the end of March. Stated that, for her to have weird symptoms months later out of nowhere for when she was really healthy, she did not know what this could be. Stated that, the patient wanted to report this because she did not know whether other people had like if there was 0.001% of people that were also feeling like this and had this out of nowhere. Stated that, she did not know the dose of Ocrevus, and she had been taking Ocrevus and it was an Infusion that she did twice a year or every 6 months. The patient specifically spoke with her doctor and she meant they planned it out, so she got the vaccine prior to her infusion which was basically like a month later or after the second vaccine (further clarification was unknown hence captured as suspect conservatively). The events resulted in physician office visit. The reporter seriousness for the events was unspecified. Treatment medication included was Tylenol and meloxicam. Stated that, she had been taking Tylenol and it was like a medicine Aleve but its stronger and meloxicam, 15 mg tablet once a day. Tylenol taking as she needed like might be 2 of the day. It was 500mg each, but she took 2 Tylenol in day. Stated that, as they said someone's would follow up with the patient for reassurance. Stated that, have there been any side effects like this or they did not know or they probably could not share that information. Stated that, she thought she got blood work done after, like probably 2 weeks after. She did not know what it was for and she did not remember. Stated that, it was just like, she thought, not 2 weeks after. No tests 2 weeks after (not cleared hence not checked). On 13Jun2021, the patient underwent lab and tests and procedures which included blood test, resulted as negative. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
42 2021-06-24 tingling Swelling in my chest on the left side with pain; Swelling in my chest on the left side with pain; at... Read more
Swelling in my chest on the left side with pain; Swelling in my chest on the left side with pain; at times I feel I can't breathe well; tingling in my left arm,; slight fever; headache; chills; This is a Spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration on the left arm on 13Jun2021 at 01:45 PM (Lot number: EW0196) at the age of 42-year-old as single dose for COVID-19 immunization. Medication history was yes. Past drug event was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. known allergies was none. Concomitant medication was not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 23May2021 at 12:00 PM (Lot number: EW0187) at the age of 42-year-old as single dose for COVID-19 immunization. On 13Jun2021 at 02:30 PM, the patient experienced swelling in chest on the left side with pain, at times the patient feel can't breath well, tingling in left arm, slight fever, headache and chills. No treatment was received. The outcome of events was not recovered.
42 2021-06-24 tingling Pfizer-BioNTech COVID-10 Vaccine EUA. After receiving the first dose of Pfizer vaccine, patient exp... Read more
Pfizer-BioNTech COVID-10 Vaccine EUA. After receiving the first dose of Pfizer vaccine, patient experienced tingling to the last two fingers of her right hand. VS include BP 115/69, P 64, O2 100%. Cetirizine 10mg PO administered at 1621. Before leaving clinic, patient felt comfortable with no additional or worsening symptoms.
42 2021-06-28 weakness Patient described a racing heart/chest pain immediately following administration. She then reported ... Read more
Patient described a racing heart/chest pain immediately following administration. She then reported dizziness and weakness that lasted at least 30 minutes. Blood pressure was elevated. She requested 911 to be called. She requested paramedics to transport her to the ER.
42 2021-06-28 nerve pain I discontinued Xeljanz the day of the vaccine per recommendation from rheumatology websites and stay... Read more
I discontinued Xeljanz the day of the vaccine per recommendation from rheumatology websites and stayed off for one week to ensure that my immune system would work properly for the vaccine. I had intense muscle pain in the left arm that was injected that evening and the muscle soreness spread to my whole body the next day, lasting 5 days. I also began having more intense pain in my lower back, which I believed was related to my psoriatic arthritis, but it continue to worsen. It brought on a full pain crisis episode of inflammation, causing intense nerve pain at an intensity of 10/10. I contacted my rheumatologist who prescribed prednisone to bring down the inflammation, though I am still in pain 3 weeks above my normal pain level prior to getting the COVID vaccine. I also have skin lesions or marks on my left arm near the injection site that have not yet cleared.
42 2021-06-29 breast pain, feeling hot Client report receiving first COVID vaccine on 06/28/2021, time not known but adverse reaction began... Read more
Client report receiving first COVID vaccine on 06/28/2021, time not known but adverse reaction began a couple hours after vaccination. Adverse reaction of feeling warm began between 3 and 4 pm. Client also had pain at the injection site and began to feel tired and sleepy. On 06/29/2021 client had temperature of 101.2, continued to have pain at site that shot up to the left side her of neck, left arm pit and left side of breast. Denies redness at site, numbness, nausea, diarrhea, and SOB. Client went to ED on the night of 06/29/2021. Client was given Tylenol while there and told to take as needed every 6 hours for pain and fever. Client report pain is still present today and temperature is 99.3.
42 2021-06-29 burning sensation 3 days after vaccine, burning sensation of the tongue, 6 days after face swelling/Lower half of my f... Read more
3 days after vaccine, burning sensation of the tongue, 6 days after face swelling/Lower half of my face is swollen; my eyelids were swollen; My forehead and burning sensation is all over my mouth; 3 days after vaccine, burning sensation of the tongue, 6 days after face swelling; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 14:00 (Batch/Lot Number: EW0153) as dose 1, single (age at vaccination 42-year-old) for covid-19 immunisation. Medical history included R arthritis and Migraines from an unknown date to ongoing. The patient previously took Aimovig for taken for migraines on 21Mar2021. Concomitant medication included NABUMETONE taken for an unspecified indication; HYDROXYCHLOROQUINE taken for arthritis from an unspecified start date and ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. The patient was not pregnant at the time of vaccination. On20Apr2021 14:00, patient experienced 3 days after vaccine, burning sensation of the tongue, 6 days after face swelling while on 23Apr2021 14:00, patient experienced 6 days after face swelling/Lower half of my face is swollen, my forehead and burning sensation is all over my mouth and my eyelids were swollen. Patient received a burning sensation on her tongue that was three days after that vaccine, six days after that vaccine she woke up and lower half of her face was swollen, her eyelids were swollen, her forehead and burning sensation was all over my mouth. Her first dose of the vaccine was 17Apr2021 and the first symptom, the burning sensation on her tongue she got three days after which was 20Apr2021, from then it just started getting worse and worse on 23Apr she just woke up with her face all swollen. (Year not clarified. Hence, not checked in tab.) Consumer stated, she took Benadryl. It seems to help with the swelling but when she woke up on Tuesday the 27Apr2021 her face was swollen again and when she started taking Benadryl it didn't help. Her face was so swollen, Benadryl doesn't help. Consumer confirmed that it was the Pfizer COVID 19 Vaccine. Consumer stated, patient took Hydroxychloroquine for her Arthritis and she took Aimovig shot for her Migraine. Hydroxychloroquine was 200 mg tablet, 1 tab by mouth daily Monday to Friday and then one tablet by mouth twice daily on Saturday and Sunday. Aimovig 140 mg once a month shot but she hasn't had that since. Last time she the shot on 21Mar2021 and she was, so she was due to take it a week ago, but she didn't because she started getting allergic reaction from the vaccine. So, she doesn't want to take another shot and have other reactions. This month she did not take it. (Further not clarified. Hence, not captured in tab.) she had blood work done for her doctor, her rheumatology doctor and she had blood work done to see if she was perimenopausal (Name not specified. Hence, not captured in tab) and that came back negative. Her rheumatology appointment was on 06Apr2021, that's when she did the testing as well blood test. Results of the test was all normal she was little bit lower on Platelet count but nothing that doctor seems to be worried about. The outcome of the events forehead and burning sensation is all over my mouth, my eyelids were swollen was unknown and other events were not recovered. Follow-up attempts completed. No further information expected.
42 2021-06-29 feeling cold, weakness, migraine This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809), via an unspecified route of administration in the left arm on 19Mar2021 at 15:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration on 27Feb2021 at 16:30 as a single dose for COVID-19 immunisation. On 19Mar2021 at 23:00, the patient had little soreness in the injection spot. She went to bed around 21:30, but she was awoken around 23:00 because she was feeling extremely cold, even after putting on layers, her electric heating blanket at the highest temperature, and She was under a down comforter. Then the scary part was her organs started to feel heavy and sore. Her lungs, liver, heart, kidneys were weighing down inside. It was difficult for her to get up and walk because she felt like she would damage an organ(s). On 20Mar2021, the patient had a fever for most of the day, and her kidneys were in so much pain. The patient tried stretching, and sleeping it off. Did not work. She drank turmeric tea and a tall glass of water with sodium chloride, himalayan pink salt, and baking soda. The pain started to subside by evening. On 21Mar2021, the patient felt much better, but had a migraine all day and felt very weak. Her kidneys were sore. The patient did not receive any treatment for events. The clinical outcome of the events Feeling extremely cold, Organs started to feel heavy and sore, Liver pain, Organs started to feel heavy and sore, Lungs pain, Organs started to feel heavy and sore, Heart pain, Difficult to get up and walk, Kidneys pain, Migraine all day, felt very weak, Soreness in the injection spot and Fever were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
42 2021-06-29 pain in extremity, weakness Achy body and joints, painful arm, fatigue, weakness, headache, chills
42 2021-06-29 pain in extremity Swollen lymph node,; Pain in whole arm and underarm; pain in whole arm and underarm; This is a spont... Read more
Swollen lymph node,; Pain in whole arm and underarm; pain in whole arm and underarm; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 17Mar2021 at 23:30 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received flu vaccine [MANUFACTURER UNKNOWN] in the left arm on 12Oct2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not tested for COVID-19. The patient experienced swollen lymph node and pain in whole arm and underarm, on 18Mar2021 at 08:00. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of swollen lymph node and pain in whole arm and underarm was reported as recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information expected
42 2021-06-29 tingling, numbness After the vaccine 2nd dose, I noticed the actual injection was painful (as compared to the 1st injec... Read more
After the vaccine 2nd dose, I noticed the actual injection was painful (as compared to the 1st injection). An hour later, I started to feel really tired. In the evening, my whole body started to hurt. I had a headache and full body aches and pain from head to toe. I did not take any medications. The next several days, I was still fatigued, my body still in pain, nausea, numbness and tingling on the right side of body (right hand and foot). I also felt feverish. On day 3, I noticed a rash which started in the center of both my palms going towards the wrists. The rash looked like hives and it was very itchy. I had itchiness on your hands, arms and legs. On 6/23/2021, I went to see my doctor. I was given Prednisone, Benadryl, triamcinolone ointment, Motrin 800mg and was diagnosed with an allergic reaction possibly to the vaccine. I am still feeling under the weather, but the rash has resolved.
42 2021-06-29 tingling has been with a multitude of symptoms since receiving Pfizer COVID vaccines, first symptoms was inte... Read more
has been with a multitude of symptoms since receiving Pfizer COVID vaccines, first symptoms was intense epigastric pain which developed 1 wk after first vaccine. Was placed on PPI without significant Improvement. delayed second dose to give body chance to recover. Had upper GI series completed, negative for any acute finings. Still with intermittent exacerbations of abdominal pain despite daily use of PPI and intermittent use of H2blocker. Has continued to see several specialists and multiple visits to the ER secondary to symptoms after second vaccines. Symptoms after second vaccine seems to be more cardiovascular and pulmonary in nature. Reports symptoms seem to be changing over time. Has been with intermittent paresthesia's, heaviness to the extremities, chest pain, palpitations and shortness of breath. Initial work up with cardiology essentially normal. (Holter monitor study, ekg, and treadmill test) Seen allergist who did V/Q scan to Rule out PE, only perfusion portion completed secondary to pandemic D-dimer was noted to be elevated- was sent to ER again for STAT imaging which was negative for DVT and PE. They placed her on prednisone for a few days which seemed to help alleviate some of her symptoms for a short period of time. Saw COVID-longhaul specialist for further evaluation/management- PFTs abnormal, unclear cause. Recommended further labs- unknown which ones. Was started on another round of prednisone which only provided minimal relief. Returned to cardiology who feel she may have secondary inflammatory response post vaccine, going for cardiac MRI to rule out myocarditis/endocarditis. Leg heaviness and paresthesia's are returning again as is her epigastric pain/abdominal pain. These started about a week after second round of steroids.
42 2021-06-30 burning sensation The first dose was taken on 03/19/2021 and the lot number is EN6199. And the second vaccine dose was... Read more
The first dose was taken on 03/19/2021 and the lot number is EN6199. And the second vaccine dose was taken on 05/24/2021 and the lot number is EP7533. After that on 05/24/2021 I was out gardening and when I took my shoes off, my toes and my shoes had a rash or breakout like I had gotten into poison ivy. The toes and fingers and toes were bright red and burned and itched, as if i had burned them in an oven or something. Doctor told me to use hydrocortisone cream.
42 2021-06-30 mild one side paralysis, speech disorder right sided weakness and numbness, difficulty speaking stroke - embolic etiology with unclear source
42 2021-06-30 migraine, numbness and pain in extremities I had joint pain, aches, and fatigue. I started to get a severe headache which was a migraine after ... Read more
I had joint pain, aches, and fatigue. I started to get a severe headache which was a migraine after I went to the Emergency Room. My arm started to swell, and I received neuropathy. I also had a herpes cold sore on my top lip and I received medication for that.
42 2021-06-30 pain in extremity, discomfort 20 days after the first dose I experienced dizziness every time I stand from my seat, haven?t experi... Read more
20 days after the first dose I experienced dizziness every time I stand from my seat, haven?t experienced this so often, still happens but not every time now. Since May 12 I am experiencing a very strong pain on the top of my right foot that started waking me up in the middle of the night for 3 days in a row, after that I?ve been feelin so much pressure in my right leg, I believe is related to blood circulation, and I even felt a strong pressure at the back of my neck. On May 14 I bought Diosmin Hesperidin over the counter, and children aspirin, I?ve been taking that since that date, it has improved very little, I can?t tell any difference. I have never experienced anything like this before, and I am very concern of a stroke or blood clog.
42 2021-06-30 pain in extremity Pain at the injection site. The pain became worse several hours later and my arm was sore and achy. ... Read more
Pain at the injection site. The pain became worse several hours later and my arm was sore and achy. I was sore for a couple of days and it never went away. It just felt like something didn't need to be there but was there. I felt it every time I moved my arm. I couldn't lift anything beyond 10lbs without having pain. i didn't seek treatment but the pain never went away.
42 2021-06-30 pain in extremity I actually ended up calling the PCP doctor on the 25th. I had muscle aches, fever and headaches. The... Read more
I actually ended up calling the PCP doctor on the 25th. I had muscle aches, fever and headaches. The headache and arm pain still had not gone away. I missed work due to the headaches from the 21st through the 27th. I also experienced nausea due to the severity of the pain. It felt like a sinus headache that throbbed. I took ibuprofen 400mg before calling the doctor but it didn't do much at all. I was also taking Tylenol 500mg 3 times a day. It wasn't until this past Monday that I saw my doctor. My shoulder and upper arm are in constant pain and it gets worse whenever I try to use my arms or move.
42 2021-06-30 tingling, pain in extremity Toes tingling on left foot less than 24 hours after vaccine. 3days later itching between toes on le... Read more
Toes tingling on left foot less than 24 hours after vaccine. 3days later itching between toes on left foot. Within one week had fungal infection between toes on left foot and extreme redness, swelling, and pain on bottom of both feet. At same time, came down with ?covid tongue?- coating and sores on tongue. This went away about 10 days later but feet are still an issue a month later.
42 2021-07-01 seizure Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: had seizure after ten ... Read more
Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: had seizure after ten minutes of gettig vaccination-Severe, Systemic: Seizure-Severe, Additional Details: called 911 pt was taken to hospital outcome unknown to pharmacy
42 2021-07-02 pain in extremity, breast pain Pt called on 07/03/2021 to report pain/swelling in the right arm. No rashes or discoloration and no ... Read more
Pt called on 07/03/2021 to report pain/swelling in the right arm. No rashes or discoloration and no restriction on the movement. Pt described pain going through right armpit to right breast Pt will observe for few more days and seek doctor's advise if needed.
42 2021-07-02 pain in extremity Low grade fever; Nausea; Soreness in arm; Severe headache; Fatigue; This is a spontaneous report rec... Read more
Low grade fever; Nausea; Soreness in arm; Severe headache; Fatigue; This is a spontaneous report received from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 23Mar2021 at 10:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant past medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced low grade fever, nausea, soreness in arm, severe headache and fatigue. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient did not receive any treatment for the events. The clinical outcome of the events low grade fever, nausea, soreness in arm, severe headache and fatigue were resolving at the time of this report . No follow-up attempts are needed. No further information is expected.
42 2021-07-03 numbness Numbness in right arm, right and left legs. Started about 2 hours after getting the 1st dose of Pfi... Read more
Numbness in right arm, right and left legs. Started about 2 hours after getting the 1st dose of Pfizer vaccine (06/30/21) and no numbness when I woke up the next morning. Fast heartbeat, intermittent pounding heartbeat at 3am 07/03/21 and was normal when I woke up the next morning I never went to the doctor
42 2021-07-04 pain in extremity twenty four hours after shot, sore on arm, and could not move it. Very fatigue, tired, felt ill with... Read more
twenty four hours after shot, sore on arm, and could not move it. Very fatigue, tired, felt ill with symptoms after shot. Missed several days of work.
42 2021-07-05 weakness I had severe body aches, chills, low grade fever, I fainted, threw up twice, was very dizzy and very... Read more
I had severe body aches, chills, low grade fever, I fainted, threw up twice, was very dizzy and very tired. I had a loss of appetite and lost the taste of some things, they didn't taste right. It took about three days to get some energy back, but I was dizzy for about 2-2.5 weeks. It took about a month before I didn't feel like I needed to stop and rest all the time. The things that didn't taste right still don't taste right.
42 2021-07-05 numbness my arm immediately began having to feeling of falling asleep/ It is from the injection site down to ... Read more
my arm immediately began having to feeling of falling asleep/ It is from the injection site down to my fingers; my arm immediately began having to feeling of falling asleep/ It is from the injection site down to my fingers; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unspecified route of administration, in left arm on 22May2021 at 13:00 (at the age of 42-years-old) as dose 2, single for covid-19 immunisation. Medical history included HBP, anxiety and shellfish allergy from an unknown date. Concomitant medications included buspirone; sertraline hydrochloride (ZOLOFT); amlodipine and metoprolol taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unspecified route of administration on 30Apr2021 (at the age of 42-years-old) in left arm for covid-19 immunization. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 22May2021 at 13:00 after receiving second dose, her arm immediately began to have feeling of falling asleep. On 20Jun2021, her arm continues to fall asleep. She can be swimming, doing nothing, sleeping, typing, resting or driving and it falls asleep. It was from the injection site down to her fingers. The case was assessed as serious (disability). No treatment was received for event. Outcome of events was not recovered. Information on the lot/batch number has been requested. Further information is expected.
42 2021-07-05 seizure She did have a seizure 3 times Saturday morning. She was admitted to Hospital Saturday, I went to em... Read more
She did have a seizure 3 times Saturday morning. She was admitted to Hospital Saturday, I went to emergency ward with her and she was kept overnight for observation; she felt dizzy; she had 3 auras, auras is very close to having seizures; This is a spontaneous report from a contactable consumer, parent. A 42-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in Arm Left on 17Jun2021 19:30 (Thursday night) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included epilepsy from an unknown date and unknown if ongoing. No concomitant medications were reported. Patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in Arm Left on 29May2021 as DOSE 1, SINGLE for COVID-19 immunization and experienced no reaction on previous exposure to vaccine. On an unspecified date, patient felt dizzy. On Saturday morning (19Jun2021), patient had 3 auras, auras were very close to having seizures. Patient did have a seizure 3 times Saturday morning. Patient was admitted to Hospital Saturday at night around 8'oclock PM, went to emergency ward and patient was kept overnight for observation the Saturday night and released on 20Jun2021. Patient had epilepsy but nothing major and according the neurologist that was she attending stated it was possible that receiving her second dose brought only auras and the seizures. The patient underwent blood test: unknown results, electroencephalogram: unknown results. The outcome of the events was unknown. Follow-up attempts are needed. Information on Lot/Batch number was available.
42 2021-07-06 migraine Constant migraines ×4days; Body aches; Tiredness; Cough; Runny nose; Loss of voice; Blurry vision; ... Read more
Constant migraines ×4days; Body aches; Tiredness; Cough; Runny nose; Loss of voice; Blurry vision; Swelling to injection site; Watery eyes; Congestion; Sob; This is a spontaneous report from a contactable other health care professional. A 42-years-old female non-pregnant patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0175), via an unspecified route of administration, in left arm (at the age of 42-year-old) on 02Jun2021 16:00 at a dose number unknown, single as for covid-19 immunization. Medical history included Arthritis, Depression, Anxiety, PTSD, COVID-19. Concomitant medications included diclofenac taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jun2021 20:00 the patient experienced constant migraines for 4days, body aches, tiredness, cough, runny nose, loss of voice, blurry vision, swelling to injection site, watery eyes, congestion, sob. The patient did not receive any treatment. The outcome of events was recovered with sequelae on an unspecified date in Jun2021. Information on Lot/Batch number was available. Additional information has been requested.
42 2021-07-06 night sweats "Pt stated pt got 1st covid vaccine Pfizer 4/26/2021. Pt said pt has tiredness, headache,chills, nig... Read more
"Pt stated pt got 1st covid vaccine Pfizer 4/26/2021. Pt said pt has tiredness, headache,chills, night sweats, cough, sore throat, sleeping pattern change after covid vaccine. Pt already contacted with PCP(outside) and prescribed melatonin for sleeping pattern change. Noted pt is allergic to Iodine, Acne cream. Pt concerned that daily activities are still affected by the symptoms of covid vaccine side effects. Pt intends to make appt with MD before 2nd covid vaccine. Pt scheduled urgent care provider 5/21/2021 for consultations d/t pt said pt is not able to communicate with PCP during the weekends. Pt made aware. Pt is educated covid vaccine side effects. Pt agreed and verbalized understanding.
42 2021-07-06 pain in extremity Pain in left leg. Unable to fully walk due to pain in left leg from the foot to the butt cheek when ... Read more
Pain in left leg. Unable to fully walk due to pain in left leg from the foot to the butt cheek when trying to step down fully.
42 2021-07-06 pain in extremity Headache, chills, fever, irritability, no appetite, cough, sneezing, body aches, immobilized, ... Read more
Headache, chills, fever, irritability, no appetite, cough, sneezing, body aches, immobilized, heartburn, sore arm, emotional, unable to care for my children, nausea, diarrhea, vomiting,
42 2021-07-07 muscle spasms, migraine Noted that symptoms began about 1 week after second dose of Pfizer COVID-19 vaccine. Symptoms initia... Read more
Noted that symptoms began about 1 week after second dose of Pfizer COVID-19 vaccine. Symptoms initially started with moderate hot flashes, constant migraine headache. Symptoms progressed to substernal chest pain that is somewhat positional however now has become constant. Pain radiation to right neck. Noticed decreased exercise tolerance such as walking moderate distances made her extremely sweaty. Went to ER on 6/29/21 after first being seen by primary doctor and found of ST depressions and was found abnormal EKG, normal D-dimer, troponin negative, placed in the rapid cardiology follow-up list. Went to ER on 7/4/2021 due to ongoing symptoms that are sharp, substernal, constant, worsened with bending over, intermittently radiating to right neck. Family history of MIs in the 40s. Patient does not smoke. Not a diabetic. New onset of right crampy groin pain and right calf pain. No history of DVT personally. Diagnosis in ER: Given the patient's clinical history, character and duration of symptoms, I am more suspicious for pericarditic equivalent rather than primary ACS. Recommend ibuprofen 400 mg 3 times a day. X10 days. We will arrange outpatient echocardiogram Once all symptoms are resolved may be in 3 to 4 weeks consider stress testing Will arrange follow-up in the office within a week DC planning from cardiac standpoint.
42 2021-07-08 weakness, speech disorder (On Tuesday, June 29th) Within the first 5 minutes, my left side and tongue went numb, I felt very l... Read more
(On Tuesday, June 29th) Within the first 5 minutes, my left side and tongue went numb, I felt very lightheaded and vision faded and felt like I was going to faint. This lasted 20 minutes. I waited 40 minutes to be sure that I was okay. For the next 3 days, my joints were stiff, did not have any energy, and slept a lot. I did not get my period as scheduled, and it still has not come- am NOT pregnant. I had a hard time recalling words, had constant headache, and lost my smell again (had covid in December, and did not get my smell back until May). I felt like an old elderly woman. I did not have any fever, body aches, or much pain in the injection site. It felt just like Covid again, except without the fever and body aches. On Friday, I was back to normal.
42 2021-07-08 facial pain Stomach ache (very minimal); could not eat the entire day; change in taste; Chills; headache; Terrib... Read more
Stomach ache (very minimal); could not eat the entire day; change in taste; Chills; headache; Terrible back ache; stabbing feeling in my left cheekbone; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic lyme and bartonella (bartonellosis). The patient had no known allergies. The patient received doxycycline (MANUFACTURER UNKNOWN), ceftriaxone sodium (ROCEPHIN) and unspecified herbal anti-inflammatories (MANUFACTURER UNKNOWN) within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 04Mar2021 at 10:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 01:00 (15 hours after the second dose), the patient woke up in the middle of the night with chills, headache, terrible back ache and a stabbing feeling in the left cheekbone and change in taste. On 25Mar2021 at 09:00 (next day), the patient had stomach ache and could not eat the entire day. The patient did not receive any treatment for these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, headache, terrible back ache, could not eat the entire day and stabbing feeling in left cheekbone was resolved on 25Mar2021 at 21:00 (all symptoms resolved), whereas for events stomach ache (very minimal) and change in taste was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
42 2021-07-08 pain in extremity Sore left arm; Fatigue; Swollen lymph nodes under left arm and along left clavicle; This is a sponta... Read more
Sore left arm; Fatigue; Swollen lymph nodes under left arm and along left clavicle; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via an unspecified route of administration on left arm on 23Mar2021 at 10:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history, however, she was allergic to milk and gluten sensitivity. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN5318) via an unspecified route of administration on the left arm on 02Mar2021 at 09:45 (at the age of 42-year-old), as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 10:30 The patient experienced sore in the left ram, fatigue and swollen lymph nodes under left arm and along left clavicle on. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore in the left ram, fatigue and swollen lymph nodes were resolving at the time of reporting. No follow-up attempts are needed. No further information expected.
42 2021-07-08 tingling Tingling hand and face.; This is a spontaneous report from a contactable consumer (patient). A 42-ye... Read more
Tingling hand and face.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiry date were not reported) via unspecified route of administration, administered in left arm on 26Feb2021 15:15 (at age of 42-year-old) as single dose, for COVID-19 immunization. Patient medical history includes high blood pressure and known allergies to Phenagen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. Patient concomitant medications include Lisinopril. The patient's past drug event included "Phenagen" and experienced allergies. On 26Feb2021 15:45 (30 mins after vaccination), patient experienced tingling hand and face. Patient did not receive any treatment for event. The outcome of event was resolved, on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-07-08 tremor, night sweats RAPID HEART RATE ABOVE 170 FOR ABOUT 3 WEEKS, INTERNAL TREAMORS, NIGHT SWEATS, ACID REFLUX, INDOSCO... Read more
RAPID HEART RATE ABOVE 170 FOR ABOUT 3 WEEKS, INTERNAL TREAMORS, NIGHT SWEATS, ACID REFLUX, INDOSCOPHY, GASTRITIS, INDIGESTION.
42 2021-07-09 numbness Tongue thrush - severe- now treating with oral suspension meds - now experiencing numbness in hands.... Read more
Tongue thrush - severe- now treating with oral suspension meds - now experiencing numbness in hands. I had sudden onset of a massive amount of tongue thrush. I have been a dental office manager for over 20 years and I don?t think I have personally seen a case as severe as mine. My throat hurt also so the Doc has me swallowing the medication rather than simply swishing and spitting. I really hope this numbness in my hands resolves itself. It is hindering my ability to write. I took my first dose of Pfizer.
42 2021-07-09 pain in extremity The first night I had a mild fever and Severe headache. Then my neck was stiff the next day and my b... Read more
The first night I had a mild fever and Severe headache. Then my neck was stiff the next day and my back was sore in addition to the headache. I had nausea and chills. I also had stomach upset with diarrhea. Then over the next few days the pain stayed in my back and I felt like I had the flu. By the 5th day, I felt like I had pain in my bones in my legs. The pain was bad enough that I couldn't sleep at night. I was taking ibuprofen several times a day and waking up in the middle of the night to take more ibuprofen. After a full two weeks of leg pain my doctor sent me to have an ultrasound of my veins in my legs because of the pain. I also had a little swelling in my left ankle. The ultrasound came back ok. The pain has subsided for the most part, but I still have pain in my left ankle. Yesterday I sat with my foot up most of the afternoon because of the pain. And it kept me up last night. I took Tylenol before bed and again at 5:00 AM because I couldn't sleep from my ankle aching. This morning when I got up, my left ankle is swollen and still aching. I have occasional pain in my legs, and left arm. But the ankle pain in my left ankle and swelling for no reason are starting to concern me. It's now been a month since my second dose of the vaccine and I'm walking with a limp because my ankle is so sore. There appears to be a bit of fluid on my ankle, or swelling. And I haven't done anything that would cause this. The pain is exactly the same as it started, its an ache in the bones and joints.
42 2021-07-10 muscle spasms Extreme cramping and heavier than normal bleeding during periods. Not being able to function due to ... Read more
Extreme cramping and heavier than normal bleeding during periods. Not being able to function due to pain much worse than normal. Almost like labor pain.
42 2021-07-11 muscle spasms, muscle twitching Body twitching while trying to sleep. Almost like the brain was "jerking" the body awake; Body twitc... Read more
Body twitching while trying to sleep. Almost like the brain was "jerking" the body awake; Body twitching while trying to sleep. Almost like the brain was "jerking" the body awake; slight spasm would take place; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EM9809), via an unspecified route of administration, administered in arm Left on 10Feb2021 at 11:00 AM (at the age of 42 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Feb2021, the patient experienced body twitching while trying to sleep. Almost like the brain was "jerking" the body awake, and a slight spasm would take place. No treatment taken for the events. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected
42 2021-07-11 tremor the patient began to experience shakiness; Feeling faint; Diaphoresis; This is a spontaneous report ... Read more
the patient began to experience shakiness; Feeling faint; Diaphoresis; This is a spontaneous report from a non-contactable health care professional. A 42-year-old female patient received first dose of her BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration on 22Mar2021 (at the age of 42-years-old) as a dose 1, single for COVID-19 immunisation. The patients medical history and concomitant medications was not reported. During 15 minutes of her waiting period on 22Mar2021, the patient experienced shakiness, feeling faint and diaphoresis and denied of events like rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Therapeutic measures for diaphoresis, shakiness and feeling faint included water and rest. Follow up response to treatment with excellent, the patient discharged with stable condition and planned to follow up with primary care physician. The clinical outcome of the event diaphoresis, shakiness and felt faint was resolving at the time of this report. No follow-up attempts needed. No further information expected Amendment: This follow-up report is being submitted to amend previously reported information: Country US added for patient in patient tab. Final sentence in analysis tab updated to No follow-up attempts needed. No further information expected
42 2021-07-12 inability to speak, trigeminal neuralgia Developed Trigeminal Neuralgia on the right side of my face 3 days after shot that still persists to... Read more
Developed Trigeminal Neuralgia on the right side of my face 3 days after shot that still persists today. Taste changed immediately following shot. Coffee, that I had drunk everyday prior to the vaccine tasted like dirt afterwards. Brain fog and unable to think of words at times.
42 2021-07-12 feeling cold, hot flush Intractable headache, 3 1/2 days (unsuccessfully treated with acetaminophen, ibuprofen; dark & quiet... Read more
Intractable headache, 3 1/2 days (unsuccessfully treated with acetaminophen, ibuprofen; dark & quiet room, heating pad); hot & cold flashes, 2 days; nausea, 3 days ( successfully treated with zofran); body aches, 3 days; moderate - severe fatigue, 3 days
42 2021-07-12 tingling Extreme body aches fever, tingling in fingers and arm. 36 hours post vaccine I had hives in multiple... Read more
Extreme body aches fever, tingling in fingers and arm. 36 hours post vaccine I had hives in multiple areas of my body. Due to my history of delayed onset reaction with Zithromax that was associated with lip and tongue tingling and a trip to the ER, I was told not to get the second shot
42 2021-07-13 weakness On the fifth it?s self I was tired felt sick to my stomach was weak on the seventh I woke up and cou... Read more
On the fifth it?s self I was tired felt sick to my stomach was weak on the seventh I woke up and couldn?t see lost my near site vision called my doctor and got my eyes examined and found out I lost my near sight I need glasses now lost my near side and some of my far vision on the 11th went to go see my dr. was having trouble breathing and had a sore throat I have respiratory issues throat issues losing my hair I have recently had an upper G.I. colonoscopy have been having lots and lots of health issues ever since my second Covid shot
42 2021-07-13 weakness The first dose got numbness in arm weakness tiredness was OK after
42 2021-07-13 unresponsive to stimuli dizziness, loss of consciousness, several minutes unable to regain consciousness, blood pressure rem... Read more
dizziness, loss of consciousness, several minutes unable to regain consciousness, blood pressure remained low, after trip to ER required two bags of liquids to bring blood pressure up to a safe level for discharge
42 2021-07-14 facial paralysis I had stroke on March 8th - I was teaching from home and I got super dizzy; I could see in front of ... Read more
I had stroke on March 8th - I was teaching from home and I got super dizzy; I could see in front of me or focus. I felt like something was wrong and I called someone. She came over and said my face was drooping on one side. I didn't know what day it was. She called the ambulance. Medical Center ER - went there in the ambulance. Confirmed a stroke at the hospital. I had TPA; I didn't have any residual damage. They put me on a statin - Lipitor and a baby aspirin to take at home.
42 2021-07-14 migraine Dizziness at time of injection, migraine the rest of the day. Nausea and slight dizziness throughou... Read more
Dizziness at time of injection, migraine the rest of the day. Nausea and slight dizziness throughout the week. Left work early 1/20/21 with nausea and vertigo, began short term disability. Contacted PCP for antibiotics thinking I had an ear infection; upon completion of antibiotic and continued symptoms, contacted PCP again and was told to see a ENT. After testing was then referred to a neurologist.
42 2021-07-14 tingling, tremor, muscle twitching, numbness, inability to speak Following the COVID vaccine I experienced the following symptoms. The neurologic symptoms progresse... Read more
Following the COVID vaccine I experienced the following symptoms. The neurologic symptoms progressed over 3 months following the vaccination. Difficultly following instructions Difficultly following conversations Difficultly with basic math Poor Memory Difficultly making complex decisions Word finding Difficultly Spelling Concentration Fatigue Depression Difficultly swallowing Coughing after eating Difficultly hearing Difficultly explaining things Left arm and leg tingling 3/20/2021 Right arm tingling 4/5/2021 Left leg numbness 4/5/2021 Difficultly with reading comprehension Tremors Pain in my right eye with movement Twitching 1st vaccine Dec 23rd - fatigue - Sore throat - Muscle aches - Ear pain - Headache 2nd vaccine Jan 13th - Fever 101. - Extreme fatigue - Sore throat - Muscle aches - Ear pain - Headache - Slept for 36 hours PCP, 3/11/2021 Labs showed, Vitamin B12 low normal Folate low normal Vitamin D low normal Started on: B12 1000 mcg Vit D5000 Folic acid 1 mg MRI April 1st showed right mild mastoid effusion Lab work, vitamin B12 and folate increase Hearing test Scheduled Wednesday 5/26/2021 Sudden lump behind right ear Itchy Feeling of fullness in ear Dull throbbing Ear drum significantly red Tenderness in jaw Tenderness in neck Tenderness behind ear Tenderness base of skull on right side Decreased sensation in right side of face Heart palpitations Wednesday night to Thursday morning PCP 5/28 Ultrasound of ear, shows enlarged lymph nodes Started on: Augmentin antibiotic The ear pain and word finding continue.
42 2021-07-16 weakness, migraine -Severe pain in joints and tendons in both arms (started on left side (injection side) then migrated... Read more
-Severe pain in joints and tendons in both arms (started on left side (injection side) then migrated to the right side as well and back pain -swollen lymph nodes in the left armpit lymph node increased to 2-3?. Both lymph nodes in throat (left and right side) significantly increased 1-2? (7/15/21 through today 7/17/21) -mild fever highest recorded 102F (11pm 7/14 through 7/16/21) -major sweat spells (7/15-7/17/21) -tinted -very light pink urine twice. First time 7/15/21, second 7/16/21. Seems like blood in Urine noticeable on toilet paper, odor similar to blood/metallic -throbbing pain in my lower right back not constant on 7/16/21, today currently not experiencing this -major body aches and chills 7/15/21-today -inside of mouth on the inside of my lips/cheeks tender and metallic taste -headache but today 7/17/21 major migraine -tired and low energy all days -nausea on/off all days -major
42 2021-07-17 weakness Developed fever up to 102; On the next day after my second shot I started to feel weakness; However ... Read more
Developed fever up to 102; On the next day after my second shot I started to feel weakness; However I still have some sleeping problems; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0182, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 21May2021 at 10:45 AM (vaccinated at the age of 42 years) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19, prior to vaccination. The most recent COVID-19 vaccine was administered at hospital. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date (vaccinated at the age of 42 years) as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, next day after the shot patient felt weakness, developed fever up to 102 but the day after that, she came to normal (however she still had some sleeping problems). The case was reported as non-serious. The outcome of all events was recovering. Device Date : 31May2021 Follow-up attempts are completed. No further information is expected.
42 2021-07-17 flushing, numbness face was red andflushed; had a warm and fuzzy numbfeeling; kind of felt weird; metallic taste; heada... Read more
face was red andflushed; had a warm and fuzzy numbfeeling; kind of felt weird; metallic taste; headache; face was red andflushed; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN620S) via an unspecified route of administration in the left arm on 23Mar2021 at 11:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included fibroids, asthma and pre-diabetic. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), salbutamol (ALBUTEROL), montelukast (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), ethinylestradiol; norgestimate (TRI-LO-SPRINTEC) and vitamin b12 (MANUFACTURER UNKNOWN). The patient had a history of allergy to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Mar2021 at 11:45, the patient felt her face was red and flushed and had a warm and fuzzy numb feeling, kind of felt weird, and had a metallic taste. The patient also experienced headache all day and the next day. Since the vaccination, the patient had been tested for COVID-19 which included a COVID-19 virus test on 26Mar2021 and the result was pending. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events face was red and flushed, numbness, weird feeling, metallic taste was resolved on 23Mar2021 at 12:45 while the clinical outcome of the event headache was resolved on 24Mar2021. No follow-up attempts are needed. No further information expected.
42 2021-07-17 flushing tingling/numbness of lips and tip of tongue; tingling/numbness of lips and tip of tongue; tingling/n... Read more
tingling/numbness of lips and tip of tongue; tingling/numbness of lips and tip of tongue; tingling/numbness of lips and tip of tongue; tingling/numbness of lips and tip of tongue; flushed face; slight constricting of throat; This is a spontaneous report from a contactable consumer. This 42-year-old female consumer reported. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:15 (age at the time of vaccination was 42-year-old) as dose 1, single for COVID-19 immunization. Medical history included urticaria and dermatitis contact from an unknown date and unknown if ongoing, I get hives from dermal contact with certain plants/animals/chemicals from an unknown date and unknown if ongoing, allergy to chemicals and allergy to animals from an unknown date and unknown if ongoing. The patient's concomitant medications was not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other medication prior to COVID-19 Vaccine. The patient reported that after 15 minutes of injection, the patient experienced tingling/numbness of lips and tip of tongue, flushed face and slight constricting of throat on 30Mar2021 12:45. Drove to emergency but did not go in, effects began to subside 30 minutes later. No treatment was received for all the events. Outcome of all the events was reported as recovered on 30Mar2021. No follow-up attempts are possible. No further information is expected.
42 2021-07-17 nerve pain, pain in extremity, cold sweat Sore arm; Nerve pain downarm into wrist.; Brain fog; Clammy hands; tired clammy hands; Stomach upset... Read more
Sore arm; Nerve pain downarm into wrist.; Brain fog; Clammy hands; tired clammy hands; Stomach upset; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep7534) via an unspecified route of administration in the left arm on 15Mar2021 at 10:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included Reynaud's, osteoarthritis, irritable bowel syndrome. Allergies to medications included penicillin, ampicillin, clindamycin and erythromycin. Concomitant medications received within 2 weeks of vaccination included vitamin (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), omega (MANUFACTURER UNKNOWN), turmeric (MANUFACTURER UNKNOWN) and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 15Mar2021 at 10:15, the patient experienced sore arm, nerve pain down arm into wrist, days after and continuing over two weeks brain fog, tired, clammy hands and upset stomach. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse events was reported as no. The clinical outcome of the events sore arm, nerve pain down arm into wrist, days after and continuing over two weeks brain fog, tired, clammy hands and upset stomach were resolved with lasting effects. No follow-ups attempts are needed. No further information is expected.
42 2021-07-17 pain in extremity, difficulty speaking Was like something sitting on her chest holding her throat closed; Chest tightness; Arm swelling up;... Read more
Was like something sitting on her chest holding her throat closed; Chest tightness; Arm swelling up; Arm pain/Sore arm; Lymph nodes very swollen; Arm pain at injection site: 5 to 6 hours after it was pretty intense; Sounded hoarse; Joint pain; was like something sitting on her chest holding her throat closed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0202, Expiry date was not reported) dose 2 via an unspecified route of administration on 28Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient's medical history (including any illness at time of vaccination) and family medical history relevant to adverse events were none. The patient did not take concomitant medications (No other products). Patient previously had first dose of BNT162b2 (Batch/lot number: EW0185) at left arm around shoulder on 04Jun2021 (at age of 42-years old) for covid-19 immunisation and experienced fatigue which started 8 hours after the first dose and treatment - took acetaminophen, Body aches which was started - 8 hours on 04Jun2021 to 09Jun2021 and she just had a sore arm as well that was super mild at the injection site. No adverse evets following prior vaccinations. No prior vaccinations (within 4 weeks. No additional vaccines administered on same date of the pfizer suspect. On 28June2021 she was okay right after the second shot for the first 5 to 6 hours, she felt normal and only had arm pain. They did inject it in the same arm. Arm pain at injection site: 5 to 6 hours after it was pretty intense, she did well with the first one. Arm swelling up: It was not mild swelling it was the size of a large grapefruit. Treatment, they advised her to put ice on it and to take ibuprofen. She looked in the mirror and her lymph nodes very swollen and she sounded hoarse and had chest tightness. She experienced it was like something sitting on her chest holding her throat closed. Lymph nodes very swollen was started at bedtime 8 or 9 pm 28Jun2021 and treatment was she went to urgent care and they sent her to the hospital. Chest tightness was started at 10pm on 28Jun2021. She had pain and tightness. Treatment was she went to the urgent care and they sent her to the hospital. She was really concerned about the lymph node swelling, joint pain, and chest and asked them what treatment there was and what could she do to feel better. The urgent care suggested going to the Emergency Room. There was no relevant tests. The outcome of the events chest tightness and chest pain was recovering, arm swelling up and lymph nodes very swollen are not recovered and rest of all events was unknown.
42 2021-07-17 pain in extremity, feeling hot dizziness; shortness of breath; her throat is tight; Sore Arm; Swollen; Warm/Hot; Painful; has a sor... Read more
dizziness; shortness of breath; her throat is tight; Sore Arm; Swollen; Warm/Hot; Painful; has a sore arm with swelling and warmth; has a sore arm with swelling and warmth; Sore Arm; Swollen; Warm/Hot; Painful; This is a spontaneous report from a contactable consumer reporting for herself. A 42-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27May2021 10:00 (Batch/Lot number was not reported) as single dose (age at vaccination 42 years) for covid-19 immunization. Medical history included covid-19 from Jan2021 to Jan2021. The patient did not administer additional vaccines on same date of the Pfizer Suspect. Family Medical History Relevant to adverse events (AEs), AEs following prior vaccinations and Prior Vaccinations (within 4 weeks) was reported as none. There were no concomitant medications. It was reported that, got 1st dose and on 27May2021 at 19:00. she has dizziness and Shortness of Breath feels like she was kind of holding her breath; feels breathing pressure. It feels like when she has a food allergy. Her throat was tight. She has a sore arm with swelling and warmth. Also reported as Sore Arm; Swollen; Warm/Hot; Painful. Patient stated, she was concerned, and she knows she has to report it, but most people have common things like arm pain and fever. Caller asking if this is a normal reaction of if she should be concerned, she has had Covid before and this feels worse. Caller states she was also concerned because her kids were getting their shots next week and she doesn't want them to feel like this. Caller states when she feels breathing pressure, she starts freaking out. Treatment: None. Caller states she opened the windows and laid back to try and open the airway. Caller states she doesn't know if she should go to the hospital or not. Caller states she was searching for information, but it didn't seem to be a common side effect. Caller states is feels like she is kind of holding her breath. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021. The patient did not visit Emergency Room for AE. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
42 2021-07-17 pain in extremity level 9 out of 10 pain in spine making it difficult to walk; 9 out of 10 pain in spine making it dif... Read more
level 9 out of 10 pain in spine making it difficult to walk; 9 out of 10 pain in spine making it difficult to walk lasting 2 weeks; pain in arm; burning in stomach; difficulty swallowing; fever greater than 103,; Swollen lymph node around neck, difficulty swallowing, burning in stomach, fever greater than 103, level 9 out of 10 pain in spine making it difficult to walk lasting 2 weeks and disappeared, pain in; This is a spontaneous report from a contactable other health care professional. A 42-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198, Expiration date: unknown), via intramuscular, administered in left arm on 03Mar2021 at 10:30 am (at the age of 42-year-old) as single dose for COVID-19 immunization in hospital. The patient medical history includes Post stage 4 breast cancer, autoimmune disease, many surgeries from breast cancer 10 plus years ago, Laminectomy L4-5 >10 years. Allergies to medications, food or other products was reported as yes, but details are not reported. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in right arm on 10Feb2021 10:30 as single dose for COVID-19 immunisation. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 03Mar2021 16:00, the patient experienced Swollen lymph node around neck, difficulty swallowing, burning in stomach, fever greater than 103, level 9 out of 10 pain in spine making it difficult to walk lasting 2 weeks and disappeared, pain in arm less than 48 hours. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was given with Tordol shot and medications for severe spams of spine and back. The events assessed as serious. The patient underwent lab tests and procedures which included body temperature (pyrexia): greater than 103 on 03Mar2021. The outcome of all events was resolved.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of Gait disturbance, Spinal pain and Pain in arm cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
42 2021-07-17 tingling, flushing, numbness Face tingling and numbness; Face tingling and numbness; flushed face; sensitive skin on fingertips; ... Read more
Face tingling and numbness; Face tingling and numbness; flushed face; sensitive skin on fingertips; feeling that face and neck were stretching my skin; This is a spontaneous report from a Non-contactable consumer, the patient. A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Dn6203), via an unspecified route of administration, administered in left arm on 26Feb2021 15:15 (at the age of 42-years-old) as a single dose for covid-19 immunization. Medical history included blood pressure abnormal, hypersensitivity. Concomitant medication(s) in two weeks included hydrochlorothiazide, multivitamins, Vitamin D. The patient had sensitivity but no confirmed allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 15:45, the patient experienced face tingling and numbness, flushed face, sensitive skin on fingertips, feeling that face and neck were stretching my skin. The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. No follow-up attempts are possible. No further information is expected.
42 2021-07-17 tingling Racing heart; Face tingling; This is a spontaneous report received from a contactable health care pr... Read more
Racing heart; Face tingling; This is a spontaneous report received from a contactable health care professional. A 42-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6207) via an unspecified route of administration on 22Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 22Mar2021 during her 15-minute waiting period after the injection, the patient began to experience racing heart and face tingling. The patient denied rash, difficulty breathing, difficulty swallowing, throat tightness and facial swelling. Treatment included water and snacks. The follow up response to treatment was good. During discharge the patient was stable to go home and follow up with PCP (Primary Care Physician). The clinical outcome of the events racing heart and tingling were recovered on 22Mar2021. No follow-up attempts are needed. No further information is expected. Amendment (30Jun2021): This follow-up report is being submitted to amend previously reported: 1. Country added for patient in patient tab 2. Event Occurred Country of event Tingling updated from 3. Treatment received box checked for event Heart racing 4. Final sentence in analysis tab updated to No follow-up attempts needed. No further information expected
42 2021-07-17 tingling Hand tingling; nausea; Medicine head feel; This is a spontaneous report from a contactable other Hea... Read more
Hand tingling; nausea; Medicine head feel; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 42 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via intramuscular route, administered in Right Arm on 28Jan2021 at 13:00 (42-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. The patients medical history included Penicillin and Sulfonamide allergy, milk and egg intolerance. The patient concomitant medications were not reported. The patient did not receive any other vaccine within in four weeks prior to vaccination. The patient was not infected with Covid prior to vaccination. On an unknown date in 2021, the patient had experienced hand tingling and medicine head feel for 30 mins with nausea occurring 2 days later. Since vaccination the patient was not tested for Covid. The outcome of the events was recovering. Follow-up attempts completed. No further information expected.
42 2021-07-18 hot flush This is a 42 year old yo female with Past Medical History and problems noted below who presents Wi... Read more
This is a 42 year old yo female with Past Medical History and problems noted below who presents With concerns of missed period x2 months She is sexually active , notes that she is trying to get pregnant Negative pregnancy test Reports hot flashes x 1 month 28 day cycle lmp 04/5/21 Denies history of similar symptoms Reports previously normal menstrual cycle up until covid vaccination with pfizer on 3/8/21 and 4/5/21 . She reports that she was on her cycle during both vaccinations and since then , has not had her menstrual cycle No mood changes No weight changes , galactorrhea
42 2021-07-18 pain in extremity Severe pain in arm, chest pain, heart flutters, gasping for air
42 2021-07-19 weakness Complains of fatigue History of covid Infection in 02/2021 Notes worsening fatigue/low energy sin... Read more
Complains of fatigue History of covid Infection in 02/2021 Notes worsening fatigue/low energy since after second covid vaccination over 1 Month ago Has been taking b12 Notes Fatigue not as bad as when she had covid infection Sometimes fatigue triggers anxiety- taking herbal supplements which helps with anxiety She is not reporting associated symptoms Denies depressed mood ,but feels irritable sometimes no suicidial Ideation + psychosocial stressors - recently bought a New home , has been having to move in between homes Social support - family + intermittent palpitations only occurs with anxiety , resolves with deep breathing , + dizziness Described as lightheadedness , denies spinning sensation or syncope She denies insmonia No chest pain no shortness of breath , no dyspnea on exertion
42 2021-07-19 muscle spasms At the time of the 1st pfizer vaccine shot, I was 5 weeks 4 days pregnant. I had no issues with the... Read more
At the time of the 1st pfizer vaccine shot, I was 5 weeks 4 days pregnant. I had no issues with the pregnancy. I have been pregnant three times prior, naturally, with no issues carrying the pregnancy to term. My due date for the pregnancy was 12/4/21. After receiving the vaccine on April 8, 2021, I felt cramping and a contraction type pain (one that would come and go) on April 12, 2021. Four days after the pain, I experience spotting and increased bleeding until the confirmed miscarriage on April 22, 2021.
42 2021-07-19 nerve pain Nerve pain at base of skull and right side of neck, nerve pain in hip, lethargic, chronic headaches,... Read more
Nerve pain at base of skull and right side of neck, nerve pain in hip, lethargic, chronic headaches, equilibrium problems, inability to stay awake, odd sensations in frontal lobe?,
42 2021-07-20 pain in extremity, numbness, tingling Extreme pain in arm, getting worse and today has become unbearable. Thumb is numb. Tingling started ... Read more
Extreme pain in arm, getting worse and today has become unbearable. Thumb is numb. Tingling started in forearm, now felt in bicep. Feeling of tightening in arm, pain radiating up through the shoulder and down through elbow. Entire arm feels numb to the touch. Episodes of increasing pain with tightening and numbness. Nausea and dizziness.
42 2021-07-20 pain in extremity Sine 06/12/2021, my body has been covered in swollen, red, itchy hives. My left arm swelled for seve... Read more
Sine 06/12/2021, my body has been covered in swollen, red, itchy hives. My left arm swelled for several days and was bruised, itchy, and very painful. The reaction on my arm subsided after a week, but the full body hives, sore throat, headache, joint pain, chest pain, and exhaustion have continued daily since. I have had swollen lymph nodes and a spot appeared on my mammogram that I had to have rechecked.
42 2021-07-20 tingling Tingly nose
42 2021-07-20 seizure Patient had a seizure approximately 10 minutes after vaccination. She was seated and her daughter w... Read more
Patient had a seizure approximately 10 minutes after vaccination. She was seated and her daughter was with her. Daughter reported seizures are common with her mom but this one seemed to be longer in duration than normal.
42 2021-07-22 burning sensation, pain in extremity It started extreme shortness of breath for a long time even before, it started bad around 10 Jul 202... Read more
It started extreme shortness of breath for a long time even before, it started bad around 10 Jul 2021 and then the pain in my chest started with adding into it on that evening of 10 Jul and 11 there was a burning pain that extended out arms. Out of breath and it hurts by any activity and in the middle of the night on the 12 Jul, it caused me to go to the ER on the 13 Jul.
42 2021-07-22 facial paralysis Feeling of having a stroke. Started at 7:30 PM on 07/22/2021 and still experiencing feeling on 07/23... Read more
Feeling of having a stroke. Started at 7:30 PM on 07/22/2021 and still experiencing feeling on 07/23/2021. One side of mouth abnormal. (drooping) Unable to sleep.
42 2021-07-22 numbness, tingling Tingling and pinching on both hands/fingers; Numbness; Blisters on tips of fingers; Bruising under n... Read more
Tingling and pinching on both hands/fingers; Numbness; Blisters on tips of fingers; Bruising under nails.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM6199) via an unspecified route of administration in the left arm on 06Mar2021 at 13:45 (at the age of 42-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 at 14:45 (at the age of 42-years-old) as single doses for COVID-19 immunisation. Medical history included diabetes type 2. The patient did not have any allergies to medications, food, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 06Mar2021 at 17:30, the patient experienced tingling and pinching on both hands/fingers also numbness, blisters on tips of fingers and bruising under nails. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. Therapeutic measures were taken as a result of events tingling and pinching on both hands/fingers, numbness, blisters on tips of fingers and bruising under nails which included treatment with prednisone (MANUFACTURER UNKNOWN) and cetirizine (MANUFACTURER UNKNOWN). The clinical outcomes of the events tingling and pinching on both hands/fingers, numbness, blisters on tips of fingers and bruising under nails were not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
42 2021-07-22 numbness Patient received 1st dose of Pfizer vaccination 0.3mL IM left deltoid by RN on 7/23/2021 at 1444. Lo... Read more
Patient received 1st dose of Pfizer vaccination 0.3mL IM left deltoid by RN on 7/23/2021 at 1444. Lot#:FA7484, Exp 9/21. 14:28 Reported to NP ?feeling left sided jaw tightness and numbness and dizziness?. Onset 4 minutes post vaccination. Location left mandible. Possible association with vaccine administration 4 minutes earlier. Temporal factors/accompanying symptoms left sided injection site soreness. Patient assessed by NP. 7/23/21 1430 VS-T98.4F, BP131/93, HR98, RR20. Denies shortness of breath, chest pain, or throat closing. Patient is well-developed, alert and oriented x4, responds to questions, heart-regular rate and rhythm, lungs clear to auscultation throughout, CN II-XII intact. NP stayed by patient?s side. Patient reported ?anxiet about getting vaccine prior to and after vaccination, but consented and wanted to get vaccination?. Patient reports personal history of anxiety, asthma, and tachycardia. Surgical history laparoscopy and D&C. Patient had root canal right upper mandible two weeks prior to vaccination visit today. NKDA. Current medications include albuterol as needed and prednisone as needed. Last Took Excedrin: 250mg acetaminophen/250mg NSAID/65mg caffeine on 7/23/21 at 1300. Last meal eaten one hour prior to clinic visit. Administered patient bottle of water. Reports family history of heart disease, HTN, and Diabetes. Last visit to primary care provider was one week prior to clinic visit. 7/23/2021 14:45-VS-T97.8F, BP 118/83, HR93, RR18. NP reported to MD. Patient reports ?tightness on left side of jaw improving?. 15:00-VS-T97.7F, BP125/84, HR84, RR18 ?tightness on left side of jaw continuing to improve?. Patient educated. Instructed to monitor s/s and follow up with primary care provider. For emergent symptoms call 911 and go directly to Emergency Department. Patient verbally stated ?she felt comfortable to leave?. No emergent concerns noted at this time. Patient educated. Patient left clinic 7/23/21 at 1515.
42 2021-07-22 pain in extremity About 10 days after my first dose of the Pfizer COVID-19 vaccine I started to develop what was later... Read more
About 10 days after my first dose of the Pfizer COVID-19 vaccine I started to develop what was later determined to be chillblains. I have never experienced this before. It started out feeling like a splinter was deep in a finger on my right hand. A pinpoint red dot then appeared and over days it grew in size until it looked like my finger had a red marker stain on it. This continued to progress on all digits of my right hand and then began on the left hand as well. My symptoms were at their worst on Feb 4th. At this point they were swollen, painful, red and purplish, and itchy. As the inflammation worked its way to the surface it ended with a superficial callous-like sore. Symptoms have not returned.
42 2021-07-23 numbness 1.) 07/21/21 An hour after 2nd shot, numbness in toes 2.) 07/22/21 Morning after my left eye felt l... Read more
1.) 07/21/21 An hour after 2nd shot, numbness in toes 2.) 07/22/21 Morning after my left eye felt like it was getting pink eye but no outward symptoms of pink eye 3.) 07/23/21 Night, Raised red area around shot site. Warm to touch but not itchy. Vertigo, feeling like I?m losing my balance. Dizziness. Left leg has numbness.
42 2021-07-23 pain in extremity, tingling Patient developed pain and tingling in skin of her leg about 2-3 days after Pfizer Covid vaccine. By... Read more
Patient developed pain and tingling in skin of her leg about 2-3 days after Pfizer Covid vaccine. By 7/24 (the day of reporting) she had developed blisters and still having pain, suspecting shingles. She has had shingles in the leg previously. She will be contacting her doctor on Monday to address. At this point she is not overly distressed; she has had this before and feels she is ok to wait to talk to her doctor on Monday.
42 2021-07-23 tingling, nerve injury Loud, chronic ear tinnitus; chronic tingling tongue and skin; chronic tingling tongue and skin; keep... Read more
Loud, chronic ear tinnitus; chronic tingling tongue and skin; chronic tingling tongue and skin; keep disrupt healthy sleep; headaches; loss of sleep; loss of sleep and quality of life; exhausted; nerve damage issue; This is a spontaneous report from a contactable consumer reported for self. This 42-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 06Apr2021 at age of 42 years old (Lot Number: EW0175) as DOSE 1, SINGLE for covid-19 immunisation. None pregnant at time of vaccination. Medical history included Chronic spine, knee, wrist, and shoulder issues/pain. Degenerative disc disease in spine and Intolerant to dairy. Prior to vaccination, the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 06Apr2021, she experienced Loud, chronic ear tinnitus which was Disability. Chronic tingling tongue and skin. Never had these symptoms prior to Pfizer covid vaccination. These side effects keep disrupt healthy sleep and cause headaches. Concerned as to what the long term side effects will be from loss of sleep and quality of life. She was exhausted. Concerned if this is a nerve damage issue. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
42 2021-07-24 severe one side paralysis, speech disorder April 9th at 07.50 in the morning I had a acute left middle cerebral artery stroke. Paralyzed on all... Read more
April 9th at 07.50 in the morning I had a acute left middle cerebral artery stroke. Paralyzed on all of the right side. Impaired speech. Brought in by ambulance at 08.10
42 2021-07-24 pain in extremity Patients states that 2 days after getting the vaccine that she is experiencing pain right above her ... Read more
Patients states that 2 days after getting the vaccine that she is experiencing pain right above her right ankle. Patient says she feels this pain every time she walks and believes it is tendon pain
42 2021-07-25 weakness Tired, groggy feeling, flu like symptoms, felt run down
42 2021-07-25 muscle spasms, discomfort, tremor, tingling, pain in extremity, involuntary muscle movements Within 15 minutes I started getting tingling in both feet, within a few days my lower legs felt like... Read more
Within 15 minutes I started getting tingling in both feet, within a few days my lower legs felt like they had compression socks on, felt heavy. Tingling moved up to my hands, Lips tingle. Involuntary movement of pointer finger on right hand. Muscle spasms, thigh pain. Symptoms got better in May and June. About three weeks ago my right top eye lid started twitching then the bottom eyelid. Last week my left eye started twitching, when I smile my face tremors at the end of my mouth. Tingling started back left lower leg and foot both hands. Elbow pain, involuntary movement of multiple fingers on both hands. Arms and legs ache. Thigh pain.
42 2021-07-25 pain in extremity, facial pain Puss filled bubble at the injection area, Hot to touch and very puffy and painful. Sharp pain spread... Read more
Puss filled bubble at the injection area, Hot to touch and very puffy and painful. Sharp pain spreading throughout my arm and leg and where my fingers and wrist knee and ankle bend also under my chin the side of my face and back of neck all on my right side from July 14 to date. I'm still in pain to this date. I have to speak to text just to write this. I can't turn my steering wheel without my right wrist and fingers locking up in pain. I have to type for a living so this is preventing me from working and I'm right handed.
42 2021-07-25 tingling Lightheaded, tingling sensation over all of body. Difficulty in swallowing prompting call of parame... Read more
Lightheaded, tingling sensation over all of body. Difficulty in swallowing prompting call of paramedics. Vitals were taken and after 30 minutes was deemed okay to return home. No hives. Instructed to take Benadryl
42 2021-07-26 pain in extremity, severe one side paralysis At 4:00pm on 4/28/2021, I woke up paralyzed on one side (left side of body). Stayed in bed and wore ... Read more
At 4:00pm on 4/28/2021, I woke up paralyzed on one side (left side of body). Stayed in bed and wore off after 1 hour. After 1 hour, my left arm considerably stayed in pain. I took Tylenol for the pain to subside. Arm was swollen. Swelling went down. I went to the doctor and there is no swelling. Pain is present at site of injection, limit of mobility. Lifting a box with a certain amount of weight, pain comes on strong the next day at the injection site.
42 2021-07-27 weakness, night sweats Heart palpitations. Insomnia. Debilitating anxiety. Brain fog. Night Sweats. Insatiable appetite. D... Read more
Heart palpitations. Insomnia. Debilitating anxiety. Brain fog. Night Sweats. Insatiable appetite. Diarrhea. Weight loss. All of these constant since 5/23.
42 2021-07-27 muscle spasms Early vaginal bleeding; having some cramping; This is a spontaneous report from a contactable Other ... Read more
Early vaginal bleeding; having some cramping; This is a spontaneous report from a contactable Other HCP. A 42-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported/ Unable to locate or read the details) via an unspecified route of administration in Arm left on 08Mar2021 10:15 as single dose for COVID-19 immunization. Medical history was not reported. Patient has no allergies. Concomitant medication included doxycycline (ORACEA) taken for an unspecified indication and GNC multivitamin received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. On 10Mar2021 19:30 early vaginal bleeding, have regular periods and now bleeding < 2 weeks after last period and around 17:30 had some cramp. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab-Pixel LabCorp): negative on 10Mar2021. Patient didn't receive any treatment for adverse event. Outcome of the events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
42 2021-07-27 pain in extremity, tingling, muscle spasms 1-5 minutes after the shot I got a pain on the left arm and I ignored it since I was on the phone an... Read more
1-5 minutes after the shot I got a pain on the left arm and I ignored it since I was on the phone and I had received the vaccine on the right arm. I got to my car after buying something at Walgreens and I felt a pain on my leg but I also ignored it . I got home and since then I have been feeling like something is pinching me mostly on arms, legs, fingers and toes. Once it happened on my finger and it was more intense than usual and I saw my vain popping up and it was a little purple. It went away after a few minutes and today I felt that on my arm and it was also more intense than usual and I also saw my vein popping up and the area showed a big bump . It went away right now (about 7 hours later ) I only have a very tiny bump in that area. I also felt a pain kind of like cramps on my right leg and pain on certain area on my feet and I feel it when I walk . I have felt something in my head also but it feels more like small needles and it is not a headache . I don?t know what to do regarding the second shot and I tried to see a specialist right away but they need the blood tests in order to help me . I will see a doctor on 7/30 and hopefully get the order for the blood tests soon so I can see the specialist. Other than that I have been feeling tired but I understand that this is a normal symptom. I do have pictures if you need them and I can also share information about my blood tests with you and once I see a specialist I can ask him to complete this report. If you have any suggestions please email me since what concerns me is that I believe that this has to do with blood clots and I know that this can turn into a Really bad situation. Thank you
42 2021-07-27 pain in extremity Extreme body aches; Headache; Fever; Nose burning; Memory trouble; Confusion; Lethargic; Burning eye... Read more
Extreme body aches; Headache; Fever; Nose burning; Memory trouble; Confusion; Lethargic; Burning eyes; Shortness of breath; Sore arms; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 01Apr2021 at 11:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic cellulitis, fibromyalgia, chronic sinusitis, chronic bronchitis, achromobacter infection, prior septic shock, brain surgeries, breast reconstruction, staphylococcal infection (staph infections), stroke and sulphonamide allergy (sulfa allergy). Concomitant medications included ceftriaxone sodium (ROCEPHIN) taken on 15Mar2021 in the right hip for an unspecified indication, ceftriaxone sodium (ROCEPHIN) taken on 16Mar2021 in the left hip for an unspecified indication and amoxicillin sodium; clavulanate potassium (AUGMENTIN) 500 milligrams taken from an unknown date for an unknown indication. The patient previously received PAXIL, EFFEXOR, TOPIMAX, CYMBALTA and morphine and experienced a drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced fatigue. On 02Apr2021, the patient experienced worsened fatigue and sore arms in the evening. On 03Apr2021 at 07:00, the patient experienced worsened fatigue, extreme body aches, a headache which was 7 on the pain scale that did not respond to medications, fever, nose burning, memory trouble, confusion, lethargic, burning eyes and shortness of breath. The patient reported that these events continued on the fourth day which was 04Apr2021. The patient reported that on 05Apr2021, the fifth day the patient still was fatigued and weak but there was some improvement. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/ department or urgent care. The patient did not receive any treatments for the events experienced except for headache for which she took unspecified medications. The clinical outcome of the events fatigue, sore arms, body ache, headache, fever, nose burning, memory trouble, confusion, lethargy, burning eyes and shortness of breath were resolved with sequelae on an unspecified date in Apr2021 at the time of this report. No follow-up attempts are needed. No further information is expected.
42 2021-07-27 pain in extremity I took the shot in left arm, it's swollen and it hurts; have swelling in my arm and in neck; I took ... Read more
I took the shot in left arm, it's swollen and it hurts; have swelling in my arm and in neck; I took the shot in left arm, it's swollen and it hurts; have swelling in my arm and in neck; I took the shot in left arm, it's swollen and it hurts; have swelling in my arm and in neck; I took the shot in left arm, it's swollen and it hurts; have swelling in my arm and in neck; I feel like a little round, like a cherry lump in my neck; Headache; Slight fever 99.9; I couldn't move my arm was swollen and neck hurt and my arm; I couldn't move my arm was swollen and neck hurt and my arm; I couldn't move my arm was swollen and neck hurt and my arm; My eyes were so heavy; Joint pain, I still have the pain in my shoulder and the lump; I still have the pain in my shoulder and the lump; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot: ENCO208, patient was unsure, hence not captured in tab; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 (at the age of 42-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included high blood pressure (hypertension) from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension, vitamins nos (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported. Patient stated, she was just have been taking hydrochlorothiazide and vitamins. The patient previously took first dose BNT162B2 on unspecified date for covid-19 immunisation. Patient stated first dose lot number as "EN I do not know if it is a O203 or it is LO." Any recent vaccines for any other conditions, any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported; any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine; history of any previous allergies to specific products or any conditions indicative of an allergy included none. The patient started experiencing after she took the shot in left arm, it's swollen and it hurts; had swelling in arm and in neck, felt like a little round, like a cherry lump in neck, headache, slight fever 99.9, couldn't move arm was swollen and neck hurt and arm, eyes were so heavy, joint pain, still had the pain in shoulder and the lump on an unspecified date. It was reported that patient received second shot of COVID Vaccine on Sunday and started experiencing like a lump in (incomplete sentence), took the shot in left arm, it's swollen and it hurts, and this is the third day and I have swelling in my arm and in neck. When paraphrased the above concern, patient stated to feel like a little round, like a cherry lump in neck. Patient was provided with the number of Pfizer Medical information Department. With respect to causality, patient stated, yes, for the second shot she did a mammogram, there was nothing there. Laboratory test included just the mammogram and the results were normal. Patient stated, the first day, didn't have any symptoms, until next morning, she had a headache, slight fever 99.9. Had lot of joint pain, couldn't move her arm was swollen and neck hurt and her arm. Patient reported to got up like 6 AM and that's all she felt she had a fever, headache, eyes were so heavy and the day before this report she got off, she was okay but still have the pain in shoulder and the lump. The patient did not require medical intervention. And stated that she did not go to the ER, as they told her that would be the side effect, what she did not know was that she would have a swollen area in her neck and arm. The patient was not hospitalized or admitted to an intensive care unit or required the initiation of new medication or other treatment or procedure. Laboratory tests or diagnostic studies were not performed, stated as not that she knew of. Clinical outcome of the events was recovering at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-07-27 tingling generalized swelling, joint pain, paresthesias, neg labwork
42 2021-07-27 tingling strange sensation in the front of head; weird taste in mouth; right above eyes where it felt like so... Read more
strange sensation in the front of head; weird taste in mouth; right above eyes where it felt like something was tingling/ coarsing through a vein; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm right on 27Mar2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, visual impairment and also reported to have a very bad eyesight in left eye and had a posterior vitreous detachment back in 2015. The patient did not report any allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT) 25mg from unknown date; for unknown indication and famotidine (MANUFACTURER UNKNOWN) 5mg from unknown date; for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Mar2021 at 16:00 the patient experienced strange sensation in the front of head, and around the forehead right above eyes where it felt like something was tingling/ coarsing through a vein (localized tingling). Patient had a very bad eyesight in left eye and had a posterior vitreous detachment back in 2015. It felt like something was happening like that when floaters started occurring in eye. Patient also felt a weird taste in mouth like when something drips down the back of your throat. This occurred a second or two after the forehead feeling and felt like if you snort something and you could taste it in your mouth slightly. Patient further stated that both of these things lasted less than a minute, possibly only like maybe up to 40 seconds. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. Patient did not receive any treatment for the events. The clinical outcome of the event strange sensation in front of head, right above eyes where it felt like something was tingling/ coarsing through a vein (localized tingling) and weird taste in mouth were recovered on 27Mar2021 at the time of this report. No follow-up attempts are possible. No further information is expected.
42 2021-07-27 tingling As soon as the shot was administered I began to feel lightheaded. I felt a tingling sensation spread... Read more
As soon as the shot was administered I began to feel lightheaded. I felt a tingling sensation spread across my face and upper body and it took a lot of willpower to focus. This effect lasted strongly; I felt a tingling sensation spread across my face and upper body; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 02Apr2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Patient was allergic to food dyes and additives when younger. Concomitant medications included ethinlyestradiol; etonogestrel (NUVARING), vitamin d (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC) from unknown date and unspecified indication. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 15:00, as soon as the shot was administered patient began to feel lightheaded and she felt a tingling sensation spread across her face and upper body and it took a lot of willpower to focus. This effect lasted strongly for 2 hours, and even by the end of the day she could feel residual effects. It was very similar to patient experienced donating platelets and her body response to the citrate. A physician friend thought it may be an anxiety response to needles, but patient stated that she had absolutely no fear of needles and had given blood many times without this effect. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lightheaded and tingling were recovered on 02Apr2021. No follow-up attempts are needed. No further information is expected.
42 2021-07-27 tremor Few weeks after my second dose, starting having neck issues and tremors and made it difficult to dri... Read more
Few weeks after my second dose, starting having neck issues and tremors and made it difficult to drive and ended up in the ER and did a cat scan and referred me neurologist and he diagnosed me with Cervical Dystonia and I have been under his care.. with medication botex injection and physical therapy. . still having issues... had an MRI and nerve issues
42 2021-07-29 feeling hot felt very foggy, almost cloudy; my skin turned bright red and very hot to the touch; my skin turned ... Read more
felt very foggy, almost cloudy; my skin turned bright red and very hot to the touch; my skin turned bright red and very hot to the touch; heart started to race; blood pressure was very high; throat was itchy as well as my whole body from like the inside out; throat was itchy as well as my whole body from like the inside out; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 42-year-old administered in Arm Right on 01Apr2021 13:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included svt (supraventricular tachycardia), mvp (mitral valve prolapse), high blood pressure, anxiety, known allergies: yes. Concomitant reported as the patient received unspecified drug within 2 weeks of vaccination. On 01Apr2021 13:00, within 20 seconds of receiving the vaccine, the patient felt very foggy, almost cloudy, her skin turned bright red and very hot to the touch, her heart started to race, they called an ambulance her blood pressure was very high but her o2 was at 98 despite the fact that her throat was itchy as well as her whole body from like the inside out. Events caused patient visit emergency room/department or urgent care. Events were treated with monitoring and allergy medication. The outcome of the events was recovered. The patient is not pregnant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information, the causal association between the events feeling abnormal, erythema, feeling hot, palpitation, hypertension, pruritus, throat irritation and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
42 2021-07-29 numbness, pain in extremity Felt like don't have any strength in it; Entire left arm felt numb for a whole day, so as left leg; ... Read more
Felt like don't have any strength in it; Entire left arm felt numb for a whole day, so as left leg; Soreness on left arm; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 01May2021 at 11:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient had no medical and drug history. The patient did not receive any other medications within 2 weeks of vaccination: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The patient took the vaccination on Saturday 01May2021 and everything was fine other than soreness on left arm. On 03May2021, day 3 Monday entire left arm felt numb for a whole day, so as left leg and felt like don't have any strength in it. The patient forced herself to continue normal routine. Patient used a hot water bag as treatment to stimulate muscles and went away by day 4. The clinical outcome of the events soreness on left arm and entire left arm felt numb for a whole day, so as left leg was recovered on an unknown date in May2021 and felt like don't have any strength in it was recovered on 04May2021. No follow-up attempts are needed. No further information is expected.
42 2021-07-29 tremor shaking; lost a significant amount of weight; neurological and muscle problems/neurological issues; ... Read more
shaking; lost a significant amount of weight; neurological and muscle problems/neurological issues; neurological and muscle problems; GI problems; difficult time walking; muscles are very weak; back and spine pain and neck; She is still not feeling well, it has progressed. worsened; back and spine pain and neck; back and spine pain and neck; heart rate went up to 185 and dropped pretty suddenly down to 36/Her heart was going up and down; didnt feel well; broke out on her chest, face, and everything turned beat red; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/batch no: FR8731, Expiration date not reported) via unspecified route in the right arm on 15Apr2021 (at the age of 42-year-old) as single dose for COVID-19 immunization. Medical history included malaise (not feeling great) and hard burning ear drainage from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any prior Vaccinations (within 4 weeks). The patient stated that, after the first shot she clarified prior to the first shot she was not feeling great. Then she got first shot and two days later she did not feel well, and she broke out on her chest, face, and everything turned beat red (17Apr2021). She was shaking and her heart rate went up to 185 and dropped pretty suddenly down to 36. She also lost a significant amount of weight since March and on 17Mar2021 she was 183 and patient clarified if it was related to the covid 19 vaccine. Patient also stated that beginning of march, she thought she had an infection in her hand and she went to the local urgent care and her doctor ruled that out. She was not feeling great and had a hard burning ear drainage and got a covid test on 28Mar2021, the end of march it came back negative, she was not sure if it was 28Mar2021, she clarified it was the last week in March. She had been going to the doctors almost four or five a week, blood work like crazy and the ER nine times. Two times were prior to her first vaccine. She further stated that since her heart was going up and down she was shaking so bad her mom had to call the ambulance. She had been having neurological and muscle problems, GI problems. She was having a difficult time walking, muscles were very weak, having neurological issues, back and spine pain and neck. Patient said that she herself and her and her primary care are working through everything. If its vaccine related, if she had covid and did not know it by the time she had the vaccine it's too late to get the antibody test. The adverse events resulted in emergency room and physician room visit. The patient underwent lab tests and procedures which included blood test, colonoscopy and a scope, computerized tomogram; all unknown results on an unspecified date, heart rate decreased: 36, heart rate increased: 185 on an unspecified date, magnetic resonance imaging: normal on an unspecified date, sars-cov-2 test: negative in last week of Mar2021. She got 3 CT scans but does not know the dates or the results and had a scheduled EMG (muscle, nerve study) cannot get in until October. The clinical outcome for event she broke out on her chest, face, everything turned beat red was recovered with sequel and all other events was unknown. PSCC Communication: Advised caller to follow up with primary care physician or local health care provider for treatment recommendations and medical advice. Provided caller with report reference.
43 2021-01-02 tenderness Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for... Read more
Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for 4 days. Painful to touch and hot. Increased tiredness within first 24 hours.
43 2021-01-03 migraine On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea... Read more
On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea/vomiting. Patient saw MD on 12/30/2020, MD stated patient had inflammatory response to the vaccine. Patient received a steroid injection. Patient states she feels better after steroid injection.
43 2021-01-03 pain in extremity My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but... Read more
My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.
43 2021-01-03 pain in extremity patient developed arm pain day after vaccination that lasted about 1 day.
43 2021-01-03 pain in extremity ACHINESS TO LEFT ARM. 7 HOURS AFTER RECEIVING VACCINE EXTREMELY PAINFUL WITH DECREASE ROM.
43 2021-01-03 tingling, feeling hot Pounding heart, fast breathing, warm/tingling in arms/hands, feeling like I might faint.
43 2021-01-03 paralysis, nerve pain, numbness, face paralysis, facial paralysis Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I ha... Read more
Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I had numbness and weakness in the right of my tongue which I quickly realized included the right portion of my face. Included tongue was numb and I couldn't move it. An Er trip and CT scan confirmed it was Bells Palsy. Today, My symptoms continue. Top of my head all the way to the way to bottom of neck is experiencing paralysis. Can move tongue now and it's partly numb but it's cooperating a bit more now. Nerve pain has worsened all over all the right side of face. Feels like someone has kicked face and I have a deep bruise. It's a deep ache. Nothing will take away the ache away. My eye doesn't lubricate like it should. So I have to either manually close it and wet it manually or tape it closed.
43 2021-01-04 burning sensation Symptoms started day after receiving vaccine. Started with a rash on upper back that itched and burn... Read more
Symptoms started day after receiving vaccine. Started with a rash on upper back that itched and burned for a few days, followed by whole body burning and sweating with rash on lower arms and chest along with continued rash on upper back. These symptoms come and go and are worse on different days. This continues today and I have been advised by my healthcare provider not to receive second dose which was scheduled for today 1/5/21. I did take steroids for two days but then was advised by physician to allow my body to react if I can tolerate the symptoms. Symptoms are tolerable some days but not all. No fever with the burning and sweating. No other symptoms.
43 2021-01-04 feeling hot fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was ... Read more
fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4°F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.
43 2021-01-04 feeling hot Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned... Read more
Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned red and warm and face turned red and warm; redness of hands; Rushing feeling-hands turned red and warm and face turned red and warm; Palpitations-increases heart rate; Palpitations-increases heart rate; Increased blood pressure; This is a spontaneous report from a contactable Nurse. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Dec2020 at 04:15 (at the age of 43-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. The patient was allergic to morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in a workplace clinic. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 04:30 the patient experienced a rushing feeling during which her hands turned red and warm and her face turned red and warm. At this same time, she also experienced increased blood pressure, palpitations and increases in her heart. The patient did not receive any treatment for the events. The clinical outcomes of rushing feeling during which her hands and face were warm and turned red, increased blood pressure, palpitations, increased heart rate were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
43 2021-01-04 flushing, feeling jittery No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after f... Read more
No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; This is a spontaneous report from a contactable other health care professional. A 43-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 18Dec2020 11:00 at single dose at arm (pending clarification) for COVID-19 immunization. Medical history included asthma, allergies, depression, penicillin allergy, allergies to: Mangoes, Cashews, Peaches. Concomitant medications included sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took amoxicillin and experienced known allergies: Amoxicillin. On 18Dec2020: about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant. Lasted about an hour. On 19Dec2020: afternoon - headache, nausea, fatigue started. On 20Dec2020: continued to feel fatigued and same symptoms. On 21Dec2020: headache, waves of nausea along with feeling flush (no fever ever) and elevated heart rate. On 22Dec2020: Same. The patient continued to work through all this but felt lousy. On 23Dec2020: stayed home from work because work wanted the patient to take a Covid Test (this was negative) - so laid around. Still with headache and nausea, easily fatigued. Cough started PM. On 24Dec2020: no nausea but continued headache, congested head, cough. On 25Dec2020: feeling better. No appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, and was negative on 23Dec2020. The outcome of the events was recovered. The patient did not receive treatment for the events. Information about lot/batch number has been requested.
43 2021-01-04 flushing Became flushed and described a scratchy swallowing sensation. Blood pressure was elevated. SPO2 re... Read more
Became flushed and described a scratchy swallowing sensation. Blood pressure was elevated. SPO2 remained steady at 98%. Sat with healthcare staff for additional 40 minutes. Benadryl 25mg given.
43 2021-01-04 muscle spasms Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen t... Read more
Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen to my armpit ( new and not experienced before).
43 2021-01-04 pain in extremity sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I cou... Read more
sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I could barely keep my eyes open for three days; mild headache; menstrual cramps; diarrhea; I had bizarre dreams like being attacked by zombies for three days; chills; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration at Left arm on 23Dec2020 17:45 at single dose for covid-19 immunization. Patient known allergies included Imitrex, beef, grass, weeds, trees, Cats. Other medical history included Asthma, allergies, migraine, Premenstrual syndrome (PMS), overweight. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications in two weeks. The COVID-19 vaccine was administered at Hospital. The patient experienced extreme fatigue. Her arms felt like lead for three days, and she felt so sleepy. She felt like she could barely keep her eyes open for three days. She had a mild headache. It triggered menstrual cramps and diarrhea for three days. She had bizarre dreams like being attacked by zombies for three days. She had chills for a few hours. She had a sore arm for a couple of days. Adverse events start date was 23Dec2020 10:00 PM. Treatment included Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of chills was recovered on 24Dec2020, of headache, chills, fatigue and sore arm was recovered in Dec2020, of other events was recovered on 26Dec2020.
43 2021-01-04 pain in extremity arm pain/soreness; This is a spontaneous report from a non-contactable nurse reported for herself. A... Read more
arm pain/soreness; This is a spontaneous report from a non-contactable nurse reported for herself. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) via an unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain/soreness on unspecified date. The outcome of the event arm pain/soreness was unknown. No follow-up attempts are possible. No further information is expected.
43 2021-01-04 pain in extremity Arm pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 43... Read more
Arm pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the right arm on 30Dec2020 at 08:00 (at the age of 43-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020 at 13:30, the patient experienced arm pain. No treatment was provided for the event arm pain. The outcome of the event arm pain was unknown. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
43 2021-01-04 seizure The resident who was known to have seizures, and under control for many yeas with Keppra 1000 mg twi... Read more
The resident who was known to have seizures, and under control for many yeas with Keppra 1000 mg twice a day, on the second day after vaccination developed recurrent seizures requiring hospitalization to an intensive care unit, with intubation and mechanical ventilation until 1/5/21 (to be extubated today). She is still at the hospital.
43 2021-01-05 numbness I developed intermittent Bilat leg numbness on Jan 2nd and 3rd. On Jan 4th the bilat lower leg numb... Read more
I developed intermittent Bilat leg numbness on Jan 2nd and 3rd. On Jan 4th the bilat lower leg numbness was constant all day and around 4 pm that same day I developed right forearm numbness. On Jan 5th the symptoms have seemed to have resolved in my legs, right forearm is still slightly numb. No weakness present just numbness.
43 2021-01-05 tingling Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamet... Read more
Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamethasone and Benadryl . Symptoms resolved
43 2021-01-06 flushing Immediate flushing of skin, tachycardia, impaired cognition
43 2021-01-06 numbness metallic taste, numbess tonque and left arm, no treatemnt at present
43 2021-01-06 pain in extremity, tingling, numbness I initially developed left arm soreness in the evening of administration of the injection. The follo... Read more
I initially developed left arm soreness in the evening of administration of the injection. The following day I developed chills and myalgias. On 1218 2021, I developed shooting pain down my right leg. Later that evening I developed persistent tingling and numbness in my hands, both, as well as tingling and numbness in both my feet. Since that time I have had persistent tingling and numbness. These symptoms have persisted since this time. They are worse with cold weather. Not associated with any weakness however I do have some increased fatigue ability in my right forearm, which may be unrelated.
43 2021-01-06 pain in extremity Hives of right side of body , lower and upper body .. Also in armpits... Sore arm after injection f... Read more
Hives of right side of body , lower and upper body .. Also in armpits... Sore arm after injection for a few days
43 2021-01-06 pain in extremity First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mil... Read more
First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mild pain arm. 12/17-12/18 arm pain got worse every day. 12/19 couldn't sleep at night. 12/20 limited motion in arm. Called doctor12/21. Took 400mg ibuprofen. Took Medrol for shoulder pain. 12/22 not able to sleep. Dr. wrote rx for Flexerol. Continued to take meds. Went back to work 12/23 with some pain. By 12/26 much better.
43 2021-01-07 weakness, pain in extremity I fever 102.2 , weakness, fitage , chills, head aches and arm sores. 48 hours recovered.
43 2021-01-07 weakness Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mi... Read more
Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mild fever; sore throat; profused sweating; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EL0140, expiration date unspecified), via an unspecified route of administration on 29Dec2020 10:30 at single dose at left arm, for COVID-19 immunization. Medical history included allergies to seafoods occasionally. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 31Dec2020 23:00, the patient experienced pain on injection site in couple of days, tiredness, headache, muscle pain, joint pain, weakness, mild fever, sore throat and profuse sweating. Therapy for the events included Tylenol 500 mg. It was reported that the patient was vaccinated at the hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test and procedure which included nasal swab which was negative on 11Nov2020. Outcome of events was unknown.
43 2021-01-07 weakness Headache, muscle aches, weakness, low grade of fever
43 2021-01-07 burning sensation pain at injection site. Just below left elbow to the tip of fingers c/o burning and has shooting pai... Read more
pain at injection site. Just below left elbow to the tip of fingers c/o burning and has shooting pain sensation.
43 2021-01-07 discomfort I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; I began ha... Read more
I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; discomfort 4-5 on a 0-10 scale; I also noted stollen lymph nodes in my neck, throat, and subclavicular areas.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) (Brand: Pfizer), via an unspecified route of administration from 31Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Nursing Home/Senior Living Facility. Medical history included hypertension, aneurysm of ascending aorta, erbs-duchenne palsy right arm, asthma, seasonal allergies. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), diltiazem (DILTIAZEM SR), sertraline hydrochloride (ZOLOFT). The known allergies included PCN, bananas, passion fruit. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 12h post vaccine at 01Jan2021 08:30 AM, patient began having muscle and joint aches throughout her body, discomfort 4-5 on a 0-10 scale. She also noted stollen lymph nodes in her neck, throat, and subclavicular areas. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in Jan2021. Patient didn't experience Covid prior vaccination. She took Covid tested post vaccination, covid test type post vaccination Nasal Swab on 02Jan2021, the covid test result negative. The events were reported as non-serious.
43 2021-01-07 flushing Patient develops mild hives and flushing of the neck and face approx. 1 hour after receiving dose #1... Read more
Patient develops mild hives and flushing of the neck and face approx. 1 hour after receiving dose #1 of the Pfizer-BioNTech COVID-19 vaccine. She self-ambulated to the clinic where she was assessed, vitals taken (which were stable), and offered an injection of Benadryl 25mg IM, which she accepted. Patient was continually monitored and reassessed 15, 30, and 60 minutes after her arrival at which time she was starting to feel better, less flushed, with a visible reduction in her mild hives. Patient was released to her own self-care and stated she would be calling her husband to pick her up from work.
43 2021-01-07 numbness Numbness and tingling of lips, and jaw numb, noted on her way home from hospital. Checked in with va... Read more
Numbness and tingling of lips, and jaw numb, noted on her way home from hospital. Checked in with vaccine clinic to report symptoms and be monitored for 30 minutes.Took 50mg Benedryl. Symptoms resolved 12/28/2020.
43 2021-01-07 migraine with aura Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.;... Read more
Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.; Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER, Lot number: EL1284, expiry date not reported), via an unspecified route of administration on 04Jan2021 09:00 at a single dose on Left arm for COVID-19 immunisation. Medical history included Migraine, asthma, seasonal allergies, RLS (Restless legs syndrome). Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), sumatriptan succinate (IMITREX), fluticasone propionate (FLONASE ALLERGY RELIEF). The patient previously took Amoxicillin, codeine and experienced allergies. The patient experienced ocular migraine, onset at 14:00, took 1 dose of Imitrex (25 mg) at 14:15. Vision began to improve at 14:40. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at the Hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were considered as non-serious.
43 2021-01-07 muscle twitching Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "le... Read more
Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "left eye feels funny, like twitching and my blood pressure feels high" Narrative: Pt reports high anxiety along with stated symptoms.
43 2021-01-07 pain in extremity 1/5/2021 received vaccination 1/6/2021 woke up at 6am with sore arm, muscle/joint pain, low grade fe... Read more
1/5/2021 received vaccination 1/6/2021 woke up at 6am with sore arm, muscle/joint pain, low grade fever of 100.4 . Treated with Tylenol and Ibuprofren. *I expected the second dose to be more 'hard hitting' then the first. The muscle / joint paint was a 6/10. 1/7 woke up at 4am and took Ibuprofren 1/8/ 'today i feel great'
43 2021-01-07 pain in extremity 1/7/2021 Woke up at about 6am with sore arm, muscle/joint pain, low grade fever 100.4. treated with... Read more
1/7/2021 Woke up at about 6am with sore arm, muscle/joint pain, low grade fever 100.4. treated with ibuprofren and tylenol 1/8/2021 Took more ibuprofren at 4am, 'feel just fine'. *I think that severity of the symptoms, which i was expecting, the 2nd dose was more 'hard hitting' then the first; More side affects with muscle and joint pain.
43 2021-01-08 weakness Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours pos... Read more
Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours post immunization. Severe shaking chills occurred with decreasing frequency over next 48 hours. Headache more intense for 48 hours, but persists still today (1/9/21). Nausea for 48 hours. Diarrhea lasted 4 days with decreasing frequency. Stiff and painful neck and base of skull has steadily decreased but is still present today (1/9/21).
43 2021-01-08 pain in extremity Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was abl... Read more
Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was able to sleep off her side effects. Took 800mg Ibuprofen OTC which helped. Afebrile.
43 2021-01-08 pain in extremity Started menstruation that afternoon. Off cycle... 1 week - 2 weeks early. Not typical for me... I'm ... Read more
Started menstruation that afternoon. Off cycle... 1 week - 2 weeks early. Not typical for me... I'm very regular. Not on birth control but husband has vasectomy. Chance of pregnancy is extremely unlikely. Started with bad cramping in pelvis and aching legs. Cramps have lessened. Dark blood. Brownish in color.
43 2021-01-08 tingling Tingling in right arm that radiated up to cheek and eye
43 2021-01-08 trigeminal neuralgia 5 days after injection trigeminal facial neuropathic shingles, left side of face, C3, r arm, side
43 2021-01-09 numbness, tingling Numbness and tingling in both hands, down right leg. Patient observed for 30 minutes. No worsening... Read more
Numbness and tingling in both hands, down right leg. Patient observed for 30 minutes. No worsening of condition and patient declined further medical care.
43 2021-01-10 weakness, bell's palsy L. Bell's palsy - eyelid drooping, weakness in L cheek and mouth, started about 28 hours after dose ... Read more
L. Bell's palsy - eyelid drooping, weakness in L cheek and mouth, started about 28 hours after dose #2 of the Pfizer-BioNTech vaccine
43 2021-01-10 facial paralysis, numbness, tingling, pain in extremity Day 1 - arm soreness, Day 2 - Fatigue and face numbness and tingle Day 3 - Face numbness and tingle ... Read more
Day 1 - arm soreness, Day 2 - Fatigue and face numbness and tingle Day 3 - Face numbness and tingle followed by droopy right eye and then right sided mouth drooping that comes and goes.
43 2021-01-10 flushing, burning sensation Left side burning. Flushed, Lightheaded, Heaviness in her Chest Tylenol
43 2021-01-10 muscle spasms Sever muscle spams and joint pain in my entire body felt for over 24 hours
43 2021-01-10 pain in extremity soreness/The pain radiates down to her left elbow and also goes up the neck; The pain radiates down ... Read more
soreness/The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; This is a spontaneous report from contactable other HCP (patient' husband). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. No concomitant medications. The patient had a whole lot of soreness on 01Jan2021 and it was not getting any better. His wife had called her health care provider. She had an appointment in several days. The pain radiates down to her left elbow and also goes up the neck in Jan2021. The reporter seriousness for soreness: Medically significant. The outcome of event pain was not recovered. The outcome of rest events was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event pain and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-10 pain in extremity Severe pain in shoulder/arm, motor deficit. Treated with Tylenol and Advil and ice, pain persisted ... Read more
Severe pain in shoulder/arm, motor deficit. Treated with Tylenol and Advil and ice, pain persisted approx. 48 hours. Motor deficit improved, but still present
43 2021-01-10 pain in extremity Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortne... Read more
Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortness of breath, fatigue - all resolved
43 2021-01-10 tenderness Erythema and tenderness with reactive lymph nodes left axillary area The size of erythema is 18x8 cm
43 2021-01-11 facial pain I had had minor intermittent teeth pain off and on for several weeks. With in a day of getting the v... Read more
I had had minor intermittent teeth pain off and on for several weeks. With in a day of getting the vaccine the pain began increasing to the whole left side of my face and neck and increasing in intensity. I was unable to sleep 12/24 and 12/25 and ended up going to urgent care on 12/26. Despite not having sinus fullness/drainage they diagnosed it a sinus infection and gave me antibiotics. At the end of the 5 day course my symptoms had improved some but were not gone and I was still requiring frequent Tylenol for pain so the course of antibiotics were extended. I do not know if this was caused by the vaccine, but it coincided with the vaccine.
43 2021-01-11 hot flush, feeling cold Recieved vaccine on Friday 1/8 in AM, by evening had heaviness in shoulders and headache. 1/9 AM mod... Read more
Recieved vaccine on Friday 1/8 in AM, by evening had heaviness in shoulders and headache. 1/9 AM moderate fatigue and muscle aches with headache. By 4pm nausea began and temp of 99.4. Severe muscle/joint pain and fatigue progressed from there with temp reaching high of 102.6 before fever broke around 5AM 1/10. Sunday 1/10 - moderate/severe fatigue with low grade temp of 99.6., nausea, headache. Little energy to do anything other than sit on couch. Attempted to go to work Monday 1/11, did have fatigue and headache prior to leaving for work. Once at work developed severe hot/cold flashes on and off with profuse sweating spells anytime I would move around. 1/12 still with headache and nausea.
43 2021-01-11 numbness, tingling a lot of tingling/numbness in my hand on the injection side; a lot of tingling/numbness in my hand o... Read more
a lot of tingling/numbness in my hand on the injection side; a lot of tingling/numbness in my hand on the injection side; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration on the left arm on 05Jan2021 10:45 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient previously took clarithromycin (BIAXIN) and experienced allergies. The patient verbalized, "I don't believe it's anything serious but I am experiencing a lot of tingling/numbness in my hand on the injection side" on 05Jan2021 11:30. Clinical outcome of the events was unknown.
43 2021-01-11 numbness developed right forearm numbness; intermittent bilat lower leg numbness / bilat lower leg numbness w... Read more
developed right forearm numbness; intermittent bilat lower leg numbness / bilat lower leg numbness was constant all day; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EL1284, expiry date was unknown) via an unspecified route of administration at the left arm on 30Dec2020 09:30 AM at a single dose. for COVID-19 immunization. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Jan2021, 6:30 pm and on 03Jan2021, the patient developed intermittent bilat lower leg numbness. On 04Jan2021, bilat lower leg numbness was constant all day and at 4pm that same day, she developed right forearm numbness. No weakness, just numbness. On 05Jan2021, leg numbness has resolved but still having slight right forearm numbness. On 06Jan2021, still no leg numbness but still having slight right forearm numbness. The events resulted in emergency room/department or urgent care. The patient recovered from the event "intermittent bilat lower leg numbness / bilat lower leg numbness was constant all day" on 05Jan2021. Outcome of the event "developed right forearm numbness" was recovering. No treatment was performed in response to the adverse events. The events were assessed as Non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.
43 2021-01-11 pain in extremity, feeling hot Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Sig... Read more
Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Significant discomfort or pain in right arm; Rash on face and neck; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in right arm, on 05Jan2021 at 07:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to shellfish, dust mites, cats, cockroach dander, grass, trees, and pollen. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 05Jan2021, the patient experienced redness and hard lump at injection site, warm to touch (no site reported), significant discomfort or pain in right arm, and rash on face and neck. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
43 2021-01-11 pain in extremity 1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 07... Read more
1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 0700-Facial swelling, mostly around eyes, forehead, and nose 1/11/2021 0700-Continued facial swelling limited to around eyes only 1/12/2021 0530-Continued facial swelling limited to around left eye only
43 2021-01-11 pain in extremity lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; ... Read more
lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; runny nose; tiredness/felt tired; eye pain; pain in the muscles; chills; sore pain in the arm; This is a spontaneous report from a contactable Other HCP (Dentist) reporting for herself. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 31Dec2020 at 10:00AM in the left arm for COVID-19 immunization. Lot number was EJ1685. Medical history and concomitant medications were none. On 01Jan2021 in the morning, she had a sore pain in her arm, and by nighttime she had chills. On 02Jan2021 and on 03Jan2021, Saturday and Sunday she had pain in her muscles, felt tired, and had some pain around her eye every time she moved her eyes. On 04Jan2021, Monday everything went away but she had stuffy nose and runny nose. Her stuffy and runny nose was better but she still had some congestion, but she could not blow anything out of her nose. On 05Jan2021, Tuesday she noticed she could not smell and she still could not smell. On 06Jan2021, she had no smell and no taste either. Stated everything was good at the time of report but she still could not smell or taste anything. She treated herself with Tylenol for the muscle aches. She took one 500mg Tylenol by mouth on 02Jan2021 at bedtime and then one Tylenol 500mg by mouth again on 03Jan2021. She was scheduled for the next dose 19Jan2021. Mention she was planning to get a COVID 19 test to see if she had the disease. The patient recovered from fatigue, eye pain, pain in muscles on 03Jan2021, the patient recovered from chills on 02Jan2021, the patient recovered from sore pain in the arm on 01Jan2021, the patient was recovering from nasal congestion/stuffy nose, the patient did not recover from runny nose and loss the sense of smell and taste. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pain in her muscles, felt tired,had some pain around her eye every time she moved her eyes, had no smell and no taste, and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
43 2021-01-11 tingling After my first vaccination, I had tingling all the way down to my fingertips. While I was driving ho... Read more
After my first vaccination, I had tingling all the way down to my fingertips. While I was driving home that night, my face, mouth, tongue, and cheeks became tingling. I got my second dose and and the same symptoms happened. Last night I felt feverish and was achy.
43 2021-01-12 weakness, muscle spasms Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of ... Read more
Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Too weak to perform normal activities/slept for 2 days straight; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: El1284 and Expiration Date unknown) via intramuscular route of administration on 05Jan2021 11:00 AM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: Eh9894) via intramuscular route of administration on 17Dec2020 05:00 PM (Left arm) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included known allergy and None other medical history. The concomitant drug was reported as Birth control medication. On 06Jan2021 1:30 am the patient woke up with severe all over muscles pains, with spasms that Tylenol 1000mg did not resolve. The patient had nausea, lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit. The patient slept for 2 days straight, too weak to perform normal activities. The patient continued to have some symptoms 3 days later. No treatment received for the adverse events of nausea, lymphadenopathy, pain in armpit, slept for 2 days straight, too weak to perform normal activities. No COVID prior vaccination and no COVID tested post vaccination. The outcome of event was recovering.
43 2021-01-12 weakness Fever 101.7, fever off and on for 24 hours beginning 14 hours after dose. Headache, muscle aches, ex... Read more
Fever 101.7, fever off and on for 24 hours beginning 14 hours after dose. Headache, muscle aches, extreme fatigue and weakness, same duration.
43 2021-01-12 bell's palsy, tremor Headache, Fatigue, Body Aches, Chills, Shakes, Temp 100.6 also diagnosed with Bells Palsy after see... Read more
Headache, Fatigue, Body Aches, Chills, Shakes, Temp 100.6 also diagnosed with Bells Palsy after seeing PCP on Monday 01/11/2021. Patient also went back to see PCP on 01/12/2021 for follow up.
43 2021-01-12 burning sensation moderate aching/burning sensation in knees and hips started about 7pm- resolved when awoke in mornin... Read more
moderate aching/burning sensation in knees and hips started about 7pm- resolved when awoke in morning at 6am.
43 2021-01-12 feeling cold, pain in extremity Swollen lymph nodes, fever, chills, fatigue, stiff neck, arm soreness
43 2021-01-12 numbness, tingling, facial paralysis DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED M... Read more
DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED MY FACE WOULD BE TINGLY AND NUMB FEELING-THEN ON SUNDAY HAD DROOPING OF RIGHT EYE LID WHEN I WAS TIRED-I NOW HAD SOME DROOPING OF MY MOUTH, ONLY SMOETIMES, AND MY EYE LID WHEN I AM TIRED. THE NUMB FEELING IS STILL THERE.:
43 2021-01-12 numbness, tingling I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received firs... Read more
I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received first dose on 12/23/2020 and second dose on 1/10/2021. Since vaccine I?ve noticed my reflux has been flared. I haven?t had to take Protonix in months; however, I really started to experience indigestion and chest burning/pressure a week after first dose. I started back taking Protonix and had to increase dose to twice a day on 1/5/2021. Symptoms have improved significantly but it?s still somewhat aggravated. I also experienced lower back pain and upper and lower extremities numbness/tingling maybe 2-3 time since first vaccine
43 2021-01-12 migraine Patient recieved Pfizer vaccine 01/10/21. On 01/11/21 patient started to experience a migraine. On 0... Read more
Patient recieved Pfizer vaccine 01/10/21. On 01/11/21 patient started to experience a migraine. On 01/12/21 patient started to expereince a worsened mirgraine accompanied with vomiting and severe back pain.
43 2021-01-12 pain in extremity Received vaccine on 1/7. Had mild arm soreness for 1.5 days. Mild headache 1/9 about 1 pm. Took ... Read more
Received vaccine on 1/7. Had mild arm soreness for 1.5 days. Mild headache 1/9 about 1 pm. Took 1 aleve at 3pm. at 4pm noticed some left undereye tenderness to palpation. at 11pm noticed left undereye swelling and bruising. took zyrtec and iced. in the morning 1/10 swelling was worse. continued to ice. I contacted my dermatologist who felt it was a reaction to the previous underye filler i had >2.5 years ago. she started me on a medrol dose pack. swelling resolved by 1/11 in the morning.
43 2021-01-12 pain in extremity The night after the injection, I was very lethargic, my mind was "cloudy" I couldn't form coherent s... Read more
The night after the injection, I was very lethargic, my mind was "cloudy" I couldn't form coherent sentences. Took Tyelenol before bed because my arm was very sore. Next morning, my whole body ached and had a severe tension headache, my jaw was very tense also. I was still very lethargic and my mind still "cloudy". Took Tylenol again after dinner, that night I started to feel relief from aches, headache and my mind can think more clearly.
43 2021-01-12 pain in extremity After vaccine I began to have sore throat, shoulder and neck discomfort. I experienced also right a... Read more
After vaccine I began to have sore throat, shoulder and neck discomfort. I experienced also right arm soreness which has diminished.
43 2021-01-12 tenderness, pain in extremity I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9... Read more
I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9 and took an aleve at 3pm. at 4pm i noticed mild left undereye tenderness to palpation. at 11pm i noticed left undereye swelling and and bruising. i iced and took a zyrtec. by morning on 1/10 the swelling was worse and i called my dermatologist. she felt it was a reaction to the undereye filler i had >2.5 years ago. she started me on a medrol dose pack. the swelling resolved by the morning on 1/11.
43 2021-01-13 burning sensation, burning sensation We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on... Read more
We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on her arms that progressed to her legs and torso. The rash it itchy and burns. She still has the rash today. The next day after vaccination she experienced headache and aching that subsided within 3 days. This employee has a history of Lupus and breaking out in a rash is not uncommon for her, it is actually sort of common. When asked if this is the same sort of rash she experiences after too much sun exposure or stress (due to the Lupus) she says she would describe it as the same. She did miss one day of work due to the headache, aching, and just being miserable with the rash on top of it. She did not experience hives, trouble breathing, or swelling.
43 2021-01-13 feeling cold Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at a... Read more
Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at about 34 hours post-injection.
43 2021-01-13 migraine, pain in extremity 8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54... Read more
8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54hrs post vaccine-Pounding Migraine that lasted 24hrs Pain at injection arm 24 hrs post vaccine.
43 2021-01-13 muscle twitching She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried ... Read more
She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried for a long time; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# either GL0140 or EL0140, Expiry date and NDC number were not written), via an unspecified route of administration in left arm on 23Dec2020 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient pregnant: No. She has had No positive test for covid before the vaccine, and No Antibody test before the vaccine either. She has had No issues with vaccines in the past. The patient had the vaccine on 23Dec2020 and then on 01Jan2021 she began to experience eye twitching and it hasn't gone away and it's very bothersome. It's still happening. Her first dose was on 23Dec2020. The eye twitching began on 01Jan2021, it's just the left eye, she can see the eye lid moving when it twitches, she felt it, like the eyeball itself was twitching or spasming. There were no issues with the vision in that eye. She did feel she was getting sleep, she was conscious about seeing if she was tired, both eyes felt as if she had cried for a long time but she had not cried at all and the eye that was twitching she felt it more in. She thought it was getting better in the morning because at that time she didn't feel it, but by mid-afternoon it was consistent. The twitching happened often sporadically every couple of minutes, and she was annoyed of it. Investigation Assessment: No. The outcome of the event left eye twitching was not recovered, outcome of other events was unknown.
43 2021-01-13 pain in extremity headache, chills, fever, sore arm, fatigue
43 2021-01-13 pain in extremity I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a... Read more
I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a fungal infection of the nail, however it had felt fine until it woke me up in the night. I thought I had developed cellulitis. However by the next morning it was completely gone back to how it was which is a little painful and irritated but not bad at all.
43 2021-01-13 pain in extremity arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne... Read more
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-13 tingling, weakness Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beat... Read more
Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beating fast. She also said that arms and feet felt "tingly". Patient felt this immediately after injection upon standing. Patient was escorted to chair for assessment. She was given water and pulse was normal. Patient said that she was feeling a bit better after a couple of minutes but then started experiencing chest heaviness and shakiness again. Patient alert, oriented, pulse normal, respirations normal. ER called and nurse came to clinic for assessment. Pulse was still normal upon his assessment but offered to take patient to ER via wheelchair for further assessment and patient agreed. Patient left clinic at approximately 8:55am to go to ER.
43 2021-01-13 speech disorder Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, prog... Read more
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
43 2021-01-14 weakness FEVER, BODY ACHES, NAUSEA, LOW APPETITE, WEAKNESS (FLU-LIKE SYMPTOMS) FOR 24 HOURS
43 2021-01-14 burning sensation Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning... Read more
Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
43 2021-01-14 burning sensation Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning... Read more
Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
43 2021-01-14 numbness, tingling During 30 minute observation period patient began to have a rash across their chest consistent with ... Read more
During 30 minute observation period patient began to have a rash across their chest consistent with hives and reported numbness and tingling of the R arm. Denied any other symptoms including SOB. Patient was taken to the ER for further observation where 50mg PO Benadryl was given.
43 2021-01-14 pain in extremity, burning sensation Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensatio... Read more
Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ejko85, intramuscular on 22-DEC-2020 11:45 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history had known allergies to latex. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 01:15AM, the patient experienced metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. The metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Outcome of the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
43 2021-01-14 pain in extremity Hospital Course:   Patient is a 43 y.o. female patient who originally presented to the hospital on... Read more
Hospital Course:   Patient is a 43 y.o. female patient who originally presented to the hospital on 1/3/2021 due to Left lower extremity pain and swelling. Patient found to have extensive DVT of left lower extremity and started on heparin drip. Vascular was consulted and recommended thrombolysis. Patient was also seen by IR who took patient for thrombectomy and left iliac stent placement on 01/05/2021. Patient tolerated procedure well. Patient was transitioned from heparin drip to Eliquis upon discharge. Patient given vascular follow-up as well as Hematology follow-up.
43 2021-01-14 pain in extremity Palm-sized discoloration around injection site; arm was very sore; This is a spontaneous report from... Read more
Palm-sized discoloration around injection site; arm was very sore; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 12:00 in left arm at single dose for COVID-19 immunization. Medical history included hay fever, asthma, various allergies and high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included progesterone, metformin, atorvastatin and metoprolol. On 05Jan202115:00, the patient experienced palm-sized discoloration around injection site and arm was very sore for two days. No treatment was given to the patient for the events. The patient recovered from the events on unspecified date. The patient underwent laboratory test which includes nasal swab: negative on 07Jan2021. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. No follow-up attempts are possible; information about lot/batch cannot be obtained.
43 2021-01-14 pain in extremity Injection site soreness that developed to arm soreness with both doses.; Injection site soreness tha... Read more
Injection site soreness that developed to arm soreness with both doses.; Injection site soreness that developed to arm soreness with both doses.; This is a spontaneous report from a contactable nurse, the patient. A 43-year-old non-pregnant female patient received the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via unspecified route of administration in the right arm on 10Jan2021 at 14:45 PM (at the age of 43-year-old) as a single dose; the patient previously received the first dose of BNT162B2, Lot number: EK5730), via unspecified route of administration in the left arm on 20Dec2020 at 12:30 PM (at the age of 43-year-old) as a single dose; both for COVID-19 immunization. Medical history included asthma, obesity, hypothyroidism, hypoglycaemia, attention deficit hyperactivity disorder. The patient had allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included ibuprofen, liraglutide (SAXENDA). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021 at 20:00 PM, the patient experienced injection site soreness that developed to arm soreness with both doses. The events were reported as non-serious. The patient did not receive any treatment for the injection site soreness that developed to arm soreness with both doses. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events injection site soreness that developed to arm soreness with both doses was recovering.
43 2021-01-14 tingling 15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in ... Read more
15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in face, lips, and tongue. She was sent to the ER from the COVID clinic.
43 2021-01-14 tingling 1015-felt dizzy; tingling starting in hands and feet. EE ate a granola bar and drank some water and... Read more
1015-felt dizzy; tingling starting in hands and feet. EE ate a granola bar and drank some water and related she was feeling much better
43 2021-01-14 tremor Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Co... Read more
Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Covid vaccine here at the hospital where she works about 8:30 AM. About 10:00 she started having shakes and a headache and just not feeling right. She has had some periods of palpitations and feeling like her heart is racing as well. She called employee health and was referred in to see us. At this time she says she still has some headache and overall feels weird but no other new symptoms. No chest pain or shortness of breath or palpitations at this time. No trouble breathing. No fever. No visual changes but the light does bother her eyes. She does have a history of migraine headaches that are like this at times. The pain is in her forehead, not globally or in her neck. She has no neck pain or stiffness. She did not have much of reaction after her first vaccination. She does have a history of hypertension but has been taken off her medication because her blood pressures have been well controlled. She states that she does check them regularly at home and they have been okay. She denies any other recent sick symptoms. No other significant chronic underlying medical problems. Medications administered in the ED included ibuprofen 600mg and diphenhydramine 25mg orally at 1415, and acetaminophen 1000mg orally at 1000mg. Headache was better at 1540, blood pressure was lower at 139/90, no shaking. Pt discharged home.
43 2021-01-15 feeling cold Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute int... Read more
Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute interval after the vaccination. Then felt faint and called 911 who responded reported passed out while on 911 dispatch.
43 2021-01-15 pain in extremity Arm pain-heavy feeling, painful when moving Low grade fever 99.5 Moderate Body aches, especially lo... Read more
Arm pain-heavy feeling, painful when moving Low grade fever 99.5 Moderate Body aches, especially low back
43 2021-01-16 pain in extremity, tremor Extremely tires about 9pm normal soreness to left arm started developing Wike up at 1:00 shaking, t... Read more
Extremely tires about 9pm normal soreness to left arm started developing Wike up at 1:00 shaking, temp 101.3 Ibuprofen 600 mg taken. Its 3:55 temp is 101 1
43 2021-01-16 tingling I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole l... Read more
I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole left arm and hand felt weird. Tired.
43 2021-01-16 tremor Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to m... Read more
Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to move with out shaking
43 2021-01-17 weakness, feeling hot Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred per... Read more
Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.
43 2021-01-18 bell's palsy Bell's palsy, diagnosed by patient's physician on January 16, 2021.
43 2021-01-18 burning sensation Swollen tongue, hives, red rash all over chest/neck/arms, burning and itching. IV of benedryl and Pe... Read more
Swollen tongue, hives, red rash all over chest/neck/arms, burning and itching. IV of benedryl and Pepcid and observation in ER for 3 hours. Rash, hives, burning and itching continue which worsen when exposed to someone with Covid.
43 2021-01-18 feeling cold About 7pm I began to have chills. Intense muscle aches and my knees and hips had severe joint pain.... Read more
About 7pm I began to have chills. Intense muscle aches and my knees and hips had severe joint pain. I was so cold I could not get out of bed to use the restroom and this continued until around 11am the next morning. I also had a headache and body aches. And about 6 days out my face turned red and was super itchy. I had a prednisone prescription that I began taking 1/18 because my legs started itching and the side effects were still horrible. It made the rash begin to clear up about 50% but its still there today. No hives this time.
43 2021-01-18 migraine with aura Migraine with aura with dose #2 (Of note, also had migraine with aura after dose #1 on 12/28/2020, 4... Read more
Migraine with aura with dose #2 (Of note, also had migraine with aura after dose #1 on 12/28/2020, 46 hours after receiving the vaccine)
43 2021-01-19 weakness Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ... Read more
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
43 2021-01-19 numbness, pain in extremity Patient started feeling numbness of left hand and fingers after 10 minutes. Pain on forearm (Pressur... Read more
Patient started feeling numbness of left hand and fingers after 10 minutes. Pain on forearm (Pressure feeling) Patient was monitor for 15 more minutes, no other interventions
43 2021-01-19 pain in extremity Arm pain that lasted for approximately one day-no treatment needed Low grade fever that lasted less ... Read more
Arm pain that lasted for approximately one day-no treatment needed Low grade fever that lasted less than 12 hours-no treatment needed Mild body aches that lasted less than 12 hours-no treatment needed Gastrointestinal upset/diarrhea that lasted less than 12 hours-no treatment needed
43 2021-01-19 pain in extremity painfully sore left arm beginning the evening of the shot and continuing for 3 days. Pain radiated ... Read more
painfully sore left arm beginning the evening of the shot and continuing for 3 days. Pain radiated from elbow up to neck and caused limited range of motion light headed, headache, severe muscle ache every joint lasting 3 days rash on torso at day 3 not itchy but red
43 2021-01-19 pain in extremity Soreness in left upper arm and neck. The next day also had a 100.2 temperature with fatigue and naus... Read more
Soreness in left upper arm and neck. The next day also had a 100.2 temperature with fatigue and nausea.
43 2021-01-19 tingling 1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl ... Read more
1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl 50mg 1505: BP: 134/88, HR: 91, SpO2: 100% 1510: BP: 122/81, HR: 80; SpO2: 100% 1545: BP 135/84, HR: 80, SpO2: 100%
43 2021-01-19 tremor Fever 103, chills, shaking, major body and joint aches, pain at injection site, headache
43 2021-01-20 difficulty speaking After receiving the second dose of the COVID vaccine the patient went home but returned to the ED th... Read more
After receiving the second dose of the COVID vaccine the patient went home but returned to the ED the following day complaining of shortness of breath that feels like prior asthma attacks. She presented to the ED at 0833 short of breath with a dry cough and hoarse voice. She was given albuterol then monitored and re-evaluated at 0921. At that time the patient stated that she felt a little better, and declined any further evaluation since she reported that she felt the same as she always does while having an asthma attack. She states that she would not have come to the ER if she had not been at work and been required to. She was discharged with prednisone at 0923.
43 2021-01-20 feeling cold Starting the day after the vaccination she started feeling cold and having a headache. She then deve... Read more
Starting the day after the vaccination she started feeling cold and having a headache. She then developed a temperature of 101.1.
43 2021-01-20 pain in extremity Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 h... Read more
Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 hours after injection. Swelling of lymph nodes and pain in lymph node region in the same arm. Unable to turn a steering wheel due to pain or pick up objects with right hand. Reaction has followed the same time line as the arm. Pain is so severe that it prevents sleep.
43 2021-01-20 pain in extremity Chest pain, muscle pain, left arm soreness, fatigue
43 2021-01-20 tenderness secondary cellulitis s/p injection site reaction - softball sized erythematous wheel that is tender ... Read more
secondary cellulitis s/p injection site reaction - softball sized erythematous wheel that is tender to palpation, warm to touch, and spreading. Started on keflex
43 2021-01-20 tenderness SWOLLEN UNDERARM, TENDER TO TOUCH ON THE SAME ARM AS THE INJECTION.
43 2021-01-21 cold sweat Lightheaded, pale, rapid pulse, chest pain, anxiety, clammy.
43 2021-01-21 discomfort crushing feeling all over, left neck/shoulder stiff-PT taking Tylenol around the clock but does not ... Read more
crushing feeling all over, left neck/shoulder stiff-PT taking Tylenol around the clock but does not touch neck/shoulder discomfort.
43 2021-01-21 facial pain, discomfort swelling in her lymph nodes on the right side/ neck; soreness on the side of my face; Discomfort; Th... Read more
swelling in her lymph nodes on the right side/ neck; soreness on the side of my face; Discomfort; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via unspecified route single dose for protection from COVID-19 2 o' clock or 3 yesterday (09Jan2020), at 43-year-old. Medical history included: multiple sclerosis. Concomitant medication included: sertraline 50 mg once daily at night; antidepressant (unspecified). The patient previously took glatiramer acetate (COPAXONE) once for multiple sclerosis and amantadine, was allergic to both. The patient didn't notice soreness on the side of her face, was probably from the vaccine started yesterday (09Jan2020). The patient was doing fine but then noticing was getting swelling in her lymph nodes on the right side. The patient did not notice the swelling, but she noticed the discomfort first last night (09Jan2020), '9th, 10 pm' (not clarified further). The patient thought that it was a 'pimple' (not further clarified) there. And then later today (10Jan2020), or just maybe an hour ago, when she felt that on her neck, she found lymph nodes swollen. So far, no treatment was taken. No lab work done. Action taken for BNT162B2 was not applicable. Outcome of the events was resolved.
43 2021-01-21 flushing, feeling hot Vaccine given at 4:50pm, pt in observation area. C/o feeling hot/flushed, skin pink, ears bright pi... Read more
Vaccine given at 4:50pm, pt in observation area. C/o feeling hot/flushed, skin pink, ears bright pink. Asked to be taken to ED, stated "it could just be anxiety but I would rather be sure". Taken via wheelchair to ED immediately and placed in room on gurney. Seen by ED staff, give hydroxyzine 25mg PO at 1732. Discharged home from ED at 1847.
43 2021-01-21 flushing I started with under arm- armpit pain last night and this morning noticed that my glands and or lymp... Read more
I started with under arm- armpit pain last night and this morning noticed that my glands and or lymph nodes under the left arm are very swollen- knots. It alarmed me. I have also had diarrhea since the day of vaccine and just feel over all flushed and very sleepy/tired.
43 2021-01-21 migraine, pain in extremity About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizzine... Read more
About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizziness and migraine followed shortly after. I felt to have more of an agitated PVC, PAC and tachycardia activity than usual. This lasted Friday 1/8 through all day Sunday 1/10. On 1/11 I only suffered from the migraine. A very sore arm was only during the first night and alleviated on Saturday afternoon.
43 2021-01-21 muscle twitching 20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches i... Read more
20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches in hands, rapid heartbeat, and rash. I returned to vaccine clinic and was referred to ER. I was observed for several hours and symptoms resolved.
43 2021-01-21 tingling, numbness Dizziness numbness tingling body aches
43 2021-01-21 tingling ELEVATED BP 180 SYS, TINGLING IN FACE , DIZZY, WEAK IN LEGS.
43 2021-01-22 fibromyalgia Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, m... Read more
Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, midday body aches, chills, finger swelling and joint swelling ha, fvr low grade. I took ibuprophen. By evening add nausea, vomitting, near syncopal event (had to sit quickly b4 passing out), heart palpitations, light headed, chest pressure and just off feeling, fatigue. By 1/9 all same symptoms, 2 more near -syncopal events, rt knee pain, and asthma (I used inhaler x 3 times). Then 1/10 upon waking, I felt amazing and 100% better. During first 3days of symptoms, I slept alot.
43 2021-01-22 pain in extremity, muscle twitching Injection site soreness for about 2 days. Day 5 developed bilateral calf pain. Not unbearable, it ju... Read more
Injection site soreness for about 2 days. Day 5 developed bilateral calf pain. Not unbearable, it just felt like I had worked out my calf muscles at the gym the day before or something & I hadnt done any exercise at all that week and not at the gym in years. It seemed worst when I first started moving snd seemed to get better as I warmed up and moved around. Lasted about three days. I do vascular ultrasound and so checked myself for blood clots and I was negative. The last symptom that I dont think Ive had before is this weird pulsing or rapid twitching sensation on the back/left side of my head. Like a nerve firing maybe? I dont know. Felt like one small focal area, like fluttering.. It was very fast. It would last for like a minute or two and then stop . That happened about 3-4 times. On different days, not sure what day. It was so short lived I didnt pay much attention to it. It happened sometime between 1/18/21 & 1/22/21. It only happened one time a day.
43 2021-01-22 pain in extremity High Fever 104.6 degree Farenheit, Bad Headache back of head, between the eyes, body aches in should... Read more
High Fever 104.6 degree Farenheit, Bad Headache back of head, between the eyes, body aches in shoulders and back and throughout body. Fever lasted almost 48hours, fever would be about 101.8 to 104.6. would only go down a few points after tyelenol given, then motrin 2-3hrs later given, then back to tylenol, then back to motrin.....ect. I was drinking plenty of fluids, then resorted to cool showers, baths, and popsicles and freeze pops. Even yesterday 1.22.2021, had a low grade fever 99.2F. Arm is still currently sore, with giant red rash where injection was given, and extremely warm to touch. I tried to report, and it continually told me, my time has expired and comments were not accepted. 1.22.2021 took motrin and tylenol again due to eye pressure , headache and low grade fever. Finally felt better 130p.m 1.22.2021.
43 2021-01-22 tingling Patient returned 2 hrs after vaccination c/o shortness of breath and "tingling fingers." Hyperventil... Read more
Patient returned 2 hrs after vaccination c/o shortness of breath and "tingling fingers." Hyperventilating upon arrival. VS - 1326 - BP 129/78, HR 90, 100%. 1331 - 131/68 - HR 80, 100%. 1337 - 126/71, 83, 100%. Code yellow called. Patient to ED.
43 2021-01-23 flushing, hot flush Seen in ED for hives, itching and feeling flushed. Given diphenhydramine 50mg with resolution. Dis... Read more
Seen in ED for hives, itching and feeling flushed. Given diphenhydramine 50mg with resolution. Discharged to home from ED.
43 2021-01-23 hot flush Seen in ED for hives, itching and feeling flushed. Given diphenhydramine 50mg with resolution. Dis... Read more
Seen in ED for hives, itching and feeling flushed. Given diphenhydramine 50mg with resolution. Discharged to home from ED
43 2021-01-23 migraine I did have a scratchy throat and my arm was itchy at injection site. Next day I had a red spot and ... Read more
I did have a scratchy throat and my arm was itchy at injection site. Next day I had a red spot and lump around injection site. I did develop a migraine the day after but can't conclusively say it was from the vaccine since I get them somewhat frequently
43 2021-01-24 weakness, pain in extremity Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose... Read more
Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose, the patient developed severe pain around vaccination site and arm, followed by muscle atrophy, weakness and clinical signs consistent with acute brachial neuritis.
43 2021-01-24 burning sensation, tingling Severe joint pain, hands tingling and then after a few hours they started burning, severe headache, ... Read more
Severe joint pain, hands tingling and then after a few hours they started burning, severe headache, heart racing. These symptoms lasted throughout the night and the next morning the left side of my face was bright red and stayed that way throughout the day.
43 2021-01-24 pain in extremity Severe pain in arm, shoulder, and neck. Limited range of motion for 4 days. I could not pick thing... Read more
Severe pain in arm, shoulder, and neck. Limited range of motion for 4 days. I could not pick things up with my left arm or turn the steering wheel on my vehicle. Had difficulty sleeping because of pain. Feels almost back to normal as of today, 1/25, but still slight discomfort.
43 2021-01-24 pain in extremity Sore arm noted day of vaccine. Following day noted fatigue, dizziness, nausea, chills, body aches, ... Read more
Sore arm noted day of vaccine. Following day noted fatigue, dizziness, nausea, chills, body aches, headache. Most symptoms subsided the next day, headaches and dizziness continue daily one week later.
43 2021-01-24 pain in extremity Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fev... Read more
Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fever of 101 started along with Hyper skin sensitivity and eye sensitivity and chills. Aches turned into actual pain in my thighs and calves. It literally felt like I was hit with a baseball bat in my thighs. Fever kept climbing all day to 103.9 at 3pm. Even though I was alternating Advil and Tylenol. During afternoon and evening I had extreme dizziness. Fever, chills, fatigue, hypersensitive skin and to sunlight with my eyes have persisted for another 24 hours. I am now snd 65 hours post vaccine and I?m still running fever 100-102. With fatigue and body aches.
43 2021-01-24 tingling Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper b... Read more
Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper body, and then tachycardia. Became very nervous with the strange sensation and took pulse which was initially in normal range. This however progressed to a rapid heart rate. Overall symptoms lasted 3-4 minutes. Pulled over and exited a busy highway. Called 911 (2:22 pm) during symptoms and they said they could only call an ambulance. Had some confusion when speaking to operator, as I couldn't tell them which exit I was at although I know the exit. Ultimately, drove myself to the hospital parking lot (about 4-5 min away) as heart rate had started to return to normal. Heart rate was in normal range when I rechecked in hospital parking lot. Sat in car for about 5 minutes before deciding to drive back to vaccine clinic to report my symptoms. Clinic about 3-4 minutes away. Pulse ox was normal x 2. BP was actually elevated x 2. Waited 30 minutes before being released home.
43 2021-01-25 weakness Fever, body aches, HA, fatigue, dizzy, weak, symptoms resolved by 1/10.
43 2021-01-25 migraine, pain in extremity headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; T... Read more
headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female non-pregnant patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL3249; expiration date: unknown), intramuscular right arm on 08Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included exercise induced asthma. The patient has no known allergies. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient was not diagnosed with Covid prior to vaccination. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EJ1685) intramuscular left arm on 19Dec2020 10:00 at a single dose for covid-19 immunization but she had zero side effects. The patient reported that on her second dose, she had sore arm, fatigue, body ache, muscle ache, migraine and fogginess beginning 24 hours after receiving injection and lasting 72 hours. Slight linger of achiness and headache on the fourth day (12Jan2021) but able to work again. No treatment was received for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
43 2021-01-25 pain in extremity, feeling hot Joint pain; Arm swelled up from the shoulder to the elbow and around to the inner arm; It is hot, ha... Read more
Joint pain; Arm swelled up from the shoulder to the elbow and around to the inner arm; It is hot, hard, swollen, and extremely painful; from the shoulder to the elbow and around to the inner arm. It was hot, hard, swollen, and extremely painful.; Arm swelled up from the shoulder to the elbow and around to the inner arm; Headache; Low grade fever of 100.2F; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176; expiry date: unknown) via an unspecified route of administration in the left arm on 08Jan2021 on 15:00, at a single dose, for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), bariatric surgery, seasonal allergies, and known allergies to bee stings, flu vaccine, and monosodium glutamate (MSG). Concomitant medications included famotidine (PEPCID) and cetirizine hydrochloride (ZYRTEC), and multivitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) on 17Dec2020, at 01:00 PM, in the left arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 09Jan2021, at 14: 30, the patient's arm swelled up from the shoulder to the elbow and around to the inner arm. It was hot, hard, swollen, and extremely painful. She also had joint pain, headache, and low-grade fever of 100.2 Fahrenheit (F). The patient did not received therapy for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
43 2021-01-25 pain in extremity Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't ta... Read more
Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; generalized body pain/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; swollen lymph nodes in her left arm pit/couldn't move her arm; This is a spontaneous report from a contactable nurse reporting for herself. A 43-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 on unspecified date for COVID-19 immunization and her arm was inflamed, and so swollen, she couldn't move it. Caller was instructed to call after getting the COVID vaccine. She had a reaction after the vaccine. Her doctor said to call Pfizer. It was after she received the 2nd dose of the vaccine, Saturday (09Jan2021). She had a reaction. She developed a headache and fatigue. She had had these side effects since Saturday. They have lasted Sunday, Monday, and today/Tuesday. She was very tired, and she has generalized body pain. The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back. Literally, her whole body was so painful. She had been taken Ibuprofen 800mg and Tylenol 1g. She had been taking those every 8 hours. She took them together. When she took them, her headache and body pain was maybe a 5-6/10. If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain. She also had swollen lymph nodes in her left arm pit. Which is the arm they injected the vaccine into. She just noticed it Saturday night. She couldn't move her arm. Now, after the second, she had a swollen lymph node the size of a quarter. It had been the same size since Saturday. She was wondering if it would go away? She was also becoming forgetful. Her brain was foggy-ongoing. Like she forgot her doctors appointment today. The outcome of event "brain was foggy" was not resolved while outcome of other events were unknown. Information on the lot/batch number has been requested.
43 2021-01-25 pain in extremity Tired; legs and arms felt sore; mild headache; fever 101.1; chills; This is a spontaneous report fro... Read more
Tired; legs and arms felt sore; mild headache; fever 101.1; chills; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=EK9231) on 10Jan2021 03:30 PM (vaccine location=Left arm, dose number=2) at single dose via unknown route of administration for unknown indication. Medical history was not reported. Concomitant medications included ibuprofen (MOTRIN); vitamins NOS (MVI); calcium carbonate, colecalciferol (OSCAL D); vitamin c. Historical vaccine included patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=Ek5730), on 19Dec2020 03:15 PM, (vaccine location=Left arm, dose number=1) via unknown route of administration at single dose for unknown indication. There were unknown allergies. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination and did not have covid tested post vaccination. Patient experienced Tired, legs and arms felt sore, mild headache, fever 101.1, chills on 11Jan2021 01:30 PM. Patient did not receive any treatment. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
43 2021-01-25 pain in extremity Sever pain at the injection site and arm, chills, sever fatigue, arthralgia.
43 2021-01-25 tingling, feeling cold TINGLING. BODY ACHES AT BEDTIME. FREEZING THEN COLD. WOKE UP AT 2:30AM WITH A HEART RATE OF 96 AND T... Read more
TINGLING. BODY ACHES AT BEDTIME. FREEZING THEN COLD. WOKE UP AT 2:30AM WITH A HEART RATE OF 96 AND TEMP OF 99.6. NEXT MORNING TEMP WAS 99.9. TOOK TYLENOL.
43 2021-01-26 discomfort, feeling of body temperature change Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick... Read more
Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick. within 30 minutes of then end escalating over the next hour, I had a severe headache, bilateral, occipital, pressure in entire head and neck. The headache as also in my eyes and in my ears. Back was also painful - not as bad as neck, but i can't explain how horribly a hope a massage could fix me. There was no comfortable position to alleviate any of that. I also got the chills, constantly, suddenly switching from shivering cold to so hot i needed to take blankets off - but soon as i took the blankets off I'd be freezing cold again. I was also super nauseous, though i didn't vomit. I pretty much couldn't get out of bed much for 24-36 hours. During that time, i was unable to sleep as well, i think mostly due to the chills, constantly having to move about to keep warm or cool off, but not sure. I did take acetaminophen around 10pm 1/26 (36 hours after injection)- i felt like I knew you're not supposed to, but I couldn't take it any more and it might have less anti-inflammatory impact than ibuprofen. It dulled the pains some, but didn't make it stop. the chills and nausea mostly stopped and was able to sleep more the second night, last night. I'm now up and trying to work today (1/27). Head still has pressure headache throughout. Neck is still sore, like a pressure headache. I feel generally foggy and heavy.
43 2021-01-26 difficulty speaking Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous ... Read more
Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous report from a contactable other health professional reporting for herself. A 43-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), intramuscular in the right arm, on 29Dec2020 at 16:42, at single dose, for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, blood pressure high from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, drug allergy to triptans from an unknown date and unknown if ongoing. Past drug event included drug allergy to Topamax and Rocephin both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced rash on 29Dec2020 at 16:45 with outcome of not recovered, hives on 29Dec2020 at 16:45 with outcome of not recovered, throat started to close up on 29Dec2020 at 16:45 with outcome of not recovered. The patient was given Benadryl and EpiPen and was rushed to the emergency room (ER). The events needed emergency room visit and physician office visit. She was admitted into the hospital for 3 days and received Solu-Medrol and intravenous Benadryl every 6 hours until discharge. The reporter stated that after the reaction her voice changed. She was visited by an otorhinolaryngology (ENT) doctor on 19Jan2021 and she had functional dysphonia. Therapeutic measure included speech therapy. Outcome was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events rash, hives and throat tightness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-26 numbness, tingling 2 weeks after the first dose injections I began having symptoms of an HSV2 outbreak, although I am o... Read more
2 weeks after the first dose injections I began having symptoms of an HSV2 outbreak, although I am on suppression therapy. I have never had one since my initial diagnosis. I also began having numbness and tingling in both feet and hands. The symptoms continued through the second vaccine dose on January 16. The numbness and tingling in my extremities has become worse. An increased dose of Valacyclovir has been ineffective in treating the HSV outbreak symptoms.
43 2021-01-26 numbness, tenderness, tingling, pain in extremity, hypersensitivity of all senses 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, j... Read more
1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-26 numbness I have had ongoing facial and tongue numbness. I am unsure if my symptoms are vaccine related, howe... Read more
I have had ongoing facial and tongue numbness. I am unsure if my symptoms are vaccine related, however my symptoms did start within 72 hours of receiving the vaccination. As of today, my symptoms remain, but seem to be improving.
43 2021-01-26 pain in extremity hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her... Read more
hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side; dizzy; Heart racing; Her arm was very sore- it was difficult to lift it; Her arm was very sore- it was difficult to lift it; She did feel a little out of it, as it produced a little bit of anxiety; A mild allergic reaction; This is a spontaneous report from a contactable Other Health Professional (patient). A 43 years old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248, Expiration Date: Apr2021), via an unspecified route of administration on 12Jan2021 at 13:22 at single dose on right arm for covid-19 immunisation. Medical history included vasovagal (she did have a history of vasovagal. She talked to her doctor about this prior to the vaccine. At first when she had it her previous doctor felt a little confused. She was unsure if it was vasovagal or a blood clot in her lungs. She did get it checked out with a cat scan and there was no clot. They had to have tested her for anaphylaxis at that time. It was not a clear diagnose. Then she saw a cardiologist. She was diagnosed with vasovagal at that time. It lasted only a few months and she was fully recovered). Concomitant medications included ongoing ergocalciferol (VIT D) and ongoing vitamins NOS (MULTIVITAMIN). Patient received the vaccine on Tuesday, 12Jan2021. Her appointment was at 12:54, but she got the vaccine at 13:22. She was looking at her phone to re-schedule her second dose. She felt totally fine. At 13:27 she had this weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side. She looked up from her phone and was very dizzy. She stood up and as she did her heart started to race. It was a really weird feeling that she has never felt. She was a little out of it. She had no trouble breathing. Within 30 seconds she was completely fine. She did feel a little out of it, as it produced a little bit of anxiety. She had no other symptoms. She stayed at the facility for 30 minutes. As she was leaving one person asked how she felt and she was told to let the EMTs know. She let them know what happened. One woman working there said it could have been an anxiety attack. She did not have a lot of anxiety but she did have some. It did not feel like that. She had never had the warm sensations or heart racing. She was totally fine when talking to the EMTs. They did not seem concerned and they let her schedule her second shot. She read on Pfizer about allergic reactions. She was assuming this was what happened. A mild allergic reaction. She had no breathing issues or hives. Her arm was very sore- it was difficult to lift it. She had also never had this type of soreness with vaccines. Dizziness: She has had the dizziness a couple of times. Twice now. One when she had gotten home. It was very mild and nothing compared to what she had when she got the vaccine. Then another last night at bedtime. It was a woosh of dizziness. Arm soreness: very improved now. felt like she would normally have after getting a vaccine. The first day was intense but after a few hours was less. The next day she woke up and it was pretty much gone. She still had a little but it has mostly improved. Caller stated she would still like to get the second dose but she was a little nervous. She had it maybe once or twice since then and it has been mild with no extreme pressure drops. They thought maybe it was a virus that affected her. Her reaction to the vaccine was different. The difference was pretty significant. Vasovagal felt like her heart will stop and she will pass out. After the vaccine she felt dizzy but didn't feel faint, and had a racing heart. Nobody seemed concerned about her reaction and getting the second dose. But she read that Pfizer does not recommend getting the second dose even if you had a mild reaction. She was wondering what she should do. Her second dose is scheduled for 02Feb2021. Outcome of hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side and heart racing was resolved on 12Jan2021, dizzy was resolved on 13Jan2021, outcome of anxiety was unknown, outcome of her arm was very sore- it was difficult to lift it and a mild allergic reaction was resolving.
43 2021-01-26 pain in extremity Pinky toe pain on 1/21; fatigue 1/23; UTI 1/24; sacral pain 1/24-present; rash 1/24-present and stil... Read more
Pinky toe pain on 1/21; fatigue 1/23; UTI 1/24; sacral pain 1/24-present; rash 1/24-present and still spreading; lateral joint foot pain 1/27
43 2021-01-27 weakness Approximately one hour after first dose I began to feel chills, very tired, and a severe headache. ... Read more
Approximately one hour after first dose I began to feel chills, very tired, and a severe headache. I laid down to rest after taking two 500mg Tylenol pills. I slept on and off for over 24 hours and felt very unwell. The recurring headaches, all over muscle pain, fatigue and weakness was constant over this time.
43 2021-01-27 migraine, weakness Fever, chills, migraine, entire body aches, muscle pain, weakness , fatigue and restlessness for a f... Read more
Fever, chills, migraine, entire body aches, muscle pain, weakness , fatigue and restlessness for a full 24 hours
43 2021-01-27 pain in extremity, feeling hot intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, ... Read more
intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; redness in face and eyes; redness in face and eyes; feels warm; This is a spontaneous report from a contactable consumer (patient is girlfriend). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKH176), via an unspecified route of administration on 12Jan2021 morning at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on unspecified date for covid-19 immunization. The patient medical history was none. There were no concomitant medications. The patient was currently having side effects, stated she was having on and off, intermittent, sharp pain in her left arm, left chest and left shoulder blade, feeling the pain all on her left side on 13Jan2021. The reporter stated the patient looked worse than she did 2 hours ago, that her face was turning red and her eyes were turning red and she felt a little warm on 12Jan2021. The reporter wants to know when she should take the patient to the hospital. The reporter was encouraged to reach out to a health care provider. The outcome of events was not recovered.
43 2021-01-27 pain in extremity Nausea, diarrhea, low grade temp of 99.2. very sore arm.
43 2021-01-27 pain in extremity Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccin... Read more
Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccination clinic. I took an Aler-Tec pill and felt better 20 minutes after. My arm was sore for 2 days after and couldn?t sleep on Right side, arm hurt. Injection site was purple and bruised one week later but no pain.
43 2021-01-27 pain in extremity Arm soreness; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old fe... Read more
Arm soreness; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 23Dec2020 12:30 at a single dose for COVID prevention. Medical history included diabetic (On insulin only. Diabetic for six to seven years and have had no hypoglycemic events). There were no concomitant medications. It was reported that the patient experienced arm soreness on an unspecified date. The outcome of the event was unknown.
43 2021-01-28 weakness Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit ... Read more
Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit on 1/21 for chest pressure, lightheadedness, dizzy. Cardiac work up- negative. Discharged. Still lightheaded and dizzy 1/22 - 1/24. On 1/25 sharp chest pains went to see my PCP. She prescribed a steroid pack. 1/26 at 3:30 pm felt weak, felt like I was going to black out. Went back to the ER- full cardiac work up, head CT, admitted to the hospital for observation. Stress test on 1/27. Everything normal. Follow up with PCP on 1/29 still very lightheaded. Ordered a 48 hour heart monitor and Neurology consult.
43 2021-01-28 weakness Bad headache (migraine like, right sided) Abdominal pain Nausea Fever 100.4 Myalgias Arthralgia Pr... Read more
Bad headache (migraine like, right sided) Abdominal pain Nausea Fever 100.4 Myalgias Arthralgia Profound fatigue/weakness
43 2021-01-28 electric shock sensation, nerve pain, pain in extremity, muscle twitching Starting on the 18th I started having pain and numbness in my limbs and chest. I ended up going to t... Read more
Starting on the 18th I started having pain and numbness in my limbs and chest. I ended up going to the ER where they tested me for Covid and checked my heart. Everything came back negative. The next day I started having severe muscle weakness to where I couldn't stand for more than 5 or 10 mins without feeling like I was going to fall over. I couldn't hold anything up for long without my arms giving out. I started having muscle twitching all over including in my face. I would also have what I would describe as electrical shock nerve pain all over. I went to the ER again and everything came back okay again. I went to Urgent Care and my MD. My doctor stated after looking at the results from the ER that it was related to the vaccine. I was put on high doses of vitamins to see if it would help my body fight the reaction to the vaccine. I was taken out of work for the week because I literally couldn't do anything. I took the vitamins for 5 days before I started finally feeling better. I'm okay now for the most part. I still am having muscle twitching and nerve pain, but it is far more tolerable than it was.
43 2021-01-28 muscle twitching, depressed level of consciousness taste/smell alteration within 1 hour of vaccine / facial twitching 3 days later / CNS depression
43 2021-01-28 pain in extremity Arm pain , arm feels heavy and very painful. Lots of stomach growling, and some stomach discomfort,... Read more
Arm pain , arm feels heavy and very painful. Lots of stomach growling, and some stomach discomfort, gases and diarrhea,
43 2021-01-28 pain in extremity Large golf ball sized knot to left deltoid - at injection site. Knot is warm to touch, red, tender. ... Read more
Large golf ball sized knot to left deltoid - at injection site. Knot is warm to touch, red, tender. Unknown is knot is hematoma, abscess or cellulitis at injection site. Symptoms started x 24 hours after injection. Arm was sore after shot but knot developed approximately 24 hours later.
43 2021-01-28 tingling Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report... Read more
Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 14Jan2021 at 16:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. 25 minutes after the vaccination on 14Jan2021 (16:55), the patient's face was tingling around her mouth. It lasted for about 30 minutes. No treatment was given for the events. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the events on 14Jan2021 at 17:25.
43 2021-01-28 tingling Patient reported that her hand started feeling tingling after her vaccine. She denied any s/s of res... Read more
Patient reported that her hand started feeling tingling after her vaccine. She denied any s/s of respiratory symptoms. She has full ROM to her hand. She denied treatment to the ER. Advised her to go to the ER if the tingling continued in her hand and did not resolve or became worse. She verbalized understanding.
43 2021-01-29 muscle twitching, tremor Muscles twitches in different parts of the body, started in left arm and have been ongoing. Frequenc... Read more
Muscles twitches in different parts of the body, started in left arm and have been ongoing. Frequency has gone down since the injection. Tremors (chest feels like it is shaking/pulsating) - this started about 10 days after the injection
43 2021-01-30 feeling hot, weakness Around 8:00am, I started to feel tired and weak. Through the course of the day, I ran a fever of 102... Read more
Around 8:00am, I started to feel tired and weak. Through the course of the day, I ran a fever of 102.4. I had chills, a headache, very sore injection site, and the skin on my arms hurt. I was exhausted, but couldn't sleep. I took Tylenol, but it didn't seem to help much. I didn't have much of an appetite. Around 7:00pm, I no longer had chills but instead was very hot. About 2:00am, I woke up drenched in sweat, but felt so much better.
43 2021-01-31 facial paralysis A couple of hours after receiving the vaccine a co-worker said my eyes were very low and red. I star... Read more
A couple of hours after receiving the vaccine a co-worker said my eyes were very low and red. I started feeling extremely exhausted and even slept on my shift on my desk. My supervisor told me to go home for the day. I went home and slept through the day and night until next morning. I then started feeling myself again.
43 2021-01-31 feeling hot dizziness, woozy feeling, lightheaded; Pressure in chest; Feeling of heat across body; Frontal lobe ... Read more
dizziness, woozy feeling, lightheaded; Pressure in chest; Feeling of heat across body; Frontal lobe headache; This is a spontaneous report from a contactable other HCP (patient). A 43-year-old female patient (Not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 18Jan2021 10:45 at single dose for covid-19 immunization. Medical history included hypothyroidism, asthma, known allergies: penicillin and sulfa, bee stings. Concomitant medication in two weeks included salbutamol (ALBUTEROL), levothyroxine, liothyronine (NP THYROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dizziness, woozy feeling, lightheaded, pressure in chest, feeling of heat across body, frontal lobe headache on 18Jan2021 at time of 11:30 am. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.
43 2021-01-31 migraine 01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout t... Read more
01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout the day. 01/30/2021 very tired (to be expected), noticed I had burning in what feels like my gall bladder and developed an ?odd? stomach ache later in the day. Thought it had to do with something I ate, but consumed nothing out of the ordinary. Went to bed early, felt like I wanted to fever but never did. decided to take a tsp of children?s Allegra because I still felt ? itchy? at times. 01/31/2021 woke up to what felt like pressure on my chest, like someone was squeezing me. Thought that was odd and thought it was perhaps the way I slept. Was still tired (4AM) went back to sleep. Woke up again feeling more rested and the same feeling. It was an awful feeling. Grabbed my pulse oximeter and my oxygen was about 96 laying down. Called an. ER, thought maybe I had Covid or something as I have never felt that way before. Receptionist told me she felt the same way after she got the shot. I ate, felt better but then developed a horrific headache akin to a migraine that was so sensitive to any movement I made. Felt like someone was shaking my head, it was so painful and I became disoriented. Like. I would get confused in my thoughts. Became very sensitive to light and movement. Looking at Facebook, I had to stop because I felt like I was going to seizure. Had to really rest. Ate lunch and took a multivitamin to see if that helped. Eventually I felt better but had to be careful, take it easy. 02/01/2021 woke up this morning still tired, like my body is fighting something. And I could fell the headache coming on and noticed I was getting confused in my thoughts. I decided to stay home from work. The morning was very bad as I felt as though I wanted to seizure. Could not get a hold of my doctor. My head still hurts, not as bad, but after I eat, I get confused and can?t hold two thoughts at once if that makes sense. Head seems very sensitive to eye movement like yesterday. It?s a gross feeling, even in absence of the pain.
43 2021-02-01 numbness Severe body pain in head, neck, back, hips, knees, feet, teeth and eye sockets. Could not hold up he... Read more
Severe body pain in head, neck, back, hips, knees, feet, teeth and eye sockets. Could not hold up head. Feet numb bilaterally. Nausea. Exhaustion. All lasting 24 hours. Profuse sweating as well for last 8 hours. kidney pain. I have never experienced such pain in my entire life.
43 2021-02-01 pain in extremity Minor headache; Sore arm; This is a spontaneous report from a contactable Other-HCP. A 43-year-ol... Read more
Minor headache; Sore arm; This is a spontaneous report from a contactable Other-HCP. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 08Jan2021 at 15:30 at single dose on left deltoid/arm via an unspecified route of administration for COVID-19 immunization. Patient was instructed by head of infectious DZ Dept hospital to premedicate with Tylenol and Benadryl. On an unspecified date she experienced minor headache and sore arm, without other response to second dose. At the time of the reporting event outcome was unknown. Information about lot/batch number has been requested.
43 2021-02-01 tingling Tingling; site of injection was swollen and red; site of injection was swollen and red; Ache; Chills... Read more
Tingling; site of injection was swollen and red; site of injection was swollen and red; Ache; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) solution for injection, via an unspecified route of administration on left arm on 17Jan2021 07:00 at a single dose for Covid-19 immunization. Medical history included diabetes, cholesterol, and blood pressure. There were no concomitant medications. Patient received the first dose of the Pfizer COVID 19 vaccine on 17Jan2021 at 07:00AM in the left arm. She noticed she had aches and chills midday on Monday 18Jan2021 and also a headache all of which went away as of this morning 19Jan2021. Today (19Jan2021), this morning she woke up and her arm at the site of the injection was swollen and red. Later, she noticed she had tingling (19Jan2021) throughout the lower part of her arm and hand. The tingling was on and off and wasn't there right away. She was scheduled to receive the second dose of the vaccine 06Feb2021. Patient was looking for recommendation on second dose. Outcome of the event ache, chills, headache was recovered on 19Jan2021; tingling was not recovered; while injection was swollen and red was unknown. No follow-up activities are needed. No further information is expected.
43 2021-02-01 trigeminal neuralgia, muscle spasms Backache and back spasms; Backache and back spasms; Ear pain on right side of head; I have Trigemina... Read more
Backache and back spasms; Backache and back spasms; Ear pain on right side of head; I have Trigeminal Neuralgia and it made my face temporarily flare up with the side face pain; I have Trigeminal Neuralgia and it made my face temporarily flare up with the side face pain; This is a spontaneous report from a contactable Other Health Professional reporting for herself A 43 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 18Jan2021 at 12:15 at single dose intramuscular on arm left for COVID-19 immunization. Medical history included Trigeminal Neuralgia, asthma, High blood pressure, CSF leak out of my nose (which has spontaneously healed), Seasonal allergies, milk allergies to lactose, Allergy to arthropod sting (tongue swelled up once from a hornet sting on hand) and allergic reaction to antibiotics (hands swell up). Concomitant medications included propranolol. On 18Jan2021 soon after vaccination (reported as 18Jan2021 at 12:15), patient experienced backache and back spasms. Ear pain on right side of head. Patient had trigeminal Neuralgia and it made her face temporarily flare up with the side face pain (as reported). Patient didn't received treatment. At the time of the reporting the patient was recovering from the events. information on the lot/batch number has been requested.
43 2021-02-02 weakness Severe body aches, chills, joint pain, neck pain, pain at injection site, headache, nausea, weakness... Read more
Severe body aches, chills, joint pain, neck pain, pain at injection site, headache, nausea, weakness, fever 100.4
43 2021-02-02 flushing, tingling Immediate tingling to left side of face, followed by tachycardia & palpitations, flushing from chest... Read more
Immediate tingling to left side of face, followed by tachycardia & palpitations, flushing from chest & back up to the scalp. Taken straight to the ED, evaluated by MD, found to be very anxious & hypertensive (BP 203/128, P 110). Treated with IV Benadryl & Pepcid.
43 2021-02-02 muscle twitching, numbness felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twi... Read more
felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
43 2021-02-02 pain in extremity I developed a fever at about 11:45 pm the night I received the 2nd covid vaccine. (2/1/21). I ran a... Read more
I developed a fever at about 11:45 pm the night I received the 2nd covid vaccine. (2/1/21). I ran a fever until about 2 am on 2/3/21. I also had a headache and intense pain in my legs and my knee and hip joints.
43 2021-02-03 discomfort, pain in extremity, numbness numbness of left hand and fingers; Pain on forearm (Pressure feeling); Pain on forearm (Pressure fee... Read more
numbness of left hand and fingers; Pain on forearm (Pressure feeling); Pain on forearm (Pressure feeling); This is a spontaneous report from a contactable pharmacist. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 30Dec2020 at 12:30 on left arm at a single dose for COVID-19 immunisation. The patient has no medical history. The patient's concomitant medications were not reported. The patient started feeling numbness of left hand and fingers after 10 minutes (30Dec2020 at 12:40) and pain on forearm (pressure feeling) 30Dec2020 at 12:30. There was no treatment received for the events. The outcome of the events was recovered on an unspecified date.
43 2021-02-03 numbness Received covid vaccine #2 left deltoid yesterday ~ 9:40 am. Last evening she developed a feeling of ... Read more
Received covid vaccine #2 left deltoid yesterday ~ 9:40 am. Last evening she developed a feeling of numbness from injection site traveling down into her left thumb and fingers... "faintly feels like it's sleeping" denies discoloration, coolness to touch or difficulty with movement. Had slight localized reaction at injection site.
43 2021-02-03 pain in extremity Headache; Horrible calf pain bilaterally; I could barely walk; Horrible calf pain bilaterally; I cou... Read more
Headache; Horrible calf pain bilaterally; I could barely walk; Horrible calf pain bilaterally; I could barely walk; Major injection site soreness; my arm started getting super sore; Major injection site soreness; my arm started getting super sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) at left deltoid on 18Jan2021 12:45 PM at single dose for COVID-19 immunisation in Hospital. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), just the Vitamins and supplements. Patient was just calling to report the side effects to the Covid 19 vaccine, major injection site soreness, she was having headache today (19Jan2021) and horrible calf pain bilaterally. the first dose was 18Jan2021 and due date of second dose was 08Feb2021. As of causality, nurse practitioner stated Yes, yesterday (18Jan2021) her arm started getting super sore and it kept getting worse and then she woke up this morning and she could barely walk because her calf pain is so bad, in both of her legs. Treatment include she have taken Advil, she took 600 mg today and she took 400 mg last night. As Results of Lab work, she stated she don't have it. She asked if anyone had the calf pain with it. Patient was not recovered from the events. Event relatedness for Covid 19 vaccine with Major injection site soreness; my arm started getting super sore and Horrible calf pain bilaterally; I could barely walk were Related. Relatedness of drug to Major injection site soreness; my arm started getting super sore, Headache, Horrible calf pain bilaterally; I could barely walk per Source of assessment: Source of assessment. Method of assessment: Global Introspection. Drug result: Related.
43 2021-02-04 pain in extremity Severe pain in injection arm run from shoulder to fingers, eventually extended to chest wall on the ... Read more
Severe pain in injection arm run from shoulder to fingers, eventually extended to chest wall on the right side. Lymph node in right axilla sore, swollen and tender. Symptoms lasted 48 hours. Advil taken for symptoms.
43 2021-02-05 pain in extremity Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomit... Read more
Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomiting. Began alternating Tylenol and Ibuprofen 800mg. 6 hours to the following day- severe headaches, chills, body aches, all over joint pain. Around midnight on 1/6/21 pain in the arm that radiated up her neck. 1/7- fever of 101. Small rash around injection site and slightly down arm. Stiff neck and arm pain.
43 2021-02-06 feeling hot Received the second dose of her Pfizer COVID vaccine today when she started feeling hot and felt lik... Read more
Received the second dose of her Pfizer COVID vaccine today when she started feeling hot and felt like her tongue was numb / swelling
43 2021-02-07 migraine Severe fatigue, malaise, nausea, migraine headache all began the same afternoon as injection, approx... Read more
Severe fatigue, malaise, nausea, migraine headache all began the same afternoon as injection, approximately four hours post-injection. Symptoms lasted (and increased in intensity) for approximately 72 hours.
43 2021-02-07 tingling, numbness Within five minutes of shot, started to feel pins and needles and slight numbness in left hand. Fiv... Read more
Within five minutes of shot, started to feel pins and needles and slight numbness in left hand. Five minutes later also started to feel pins and needles and slight numbness on left side of face. Within the next 40 minutes, when I was able to take off my thick coat and boots, also felt these symptoms from shoulder down to fingers and calf down to toe (all still only on left side of body). One week later also felt same effects in left breast. When using these body parts such as hand or leg, it would get tired a lot faster then the right side, but still had full mobility and function. Symptoms are still ongoing and it is now 2 weeks later.
43 2021-02-08 weakness, tremor, muscle spasms Woke up at 1:30 am with fever. Muscles spasming, took an Advil, didn't help. Took another Advil 30 m... Read more
Woke up at 1:30 am with fever. Muscles spasming, took an Advil, didn't help. Took another Advil 30 min later, restless, can?t stay still, moaning. Muscle cramping getting worse in abdomen. Get up to get more water and urinate, starting to salivate as if going to throw up. Lean over toilet for 20 min, burning hot , weak, throw cold water around face and neck. Take another Advil, lay back down in bed, muscle convulsions for next 20 min, slowly dissipating. Entire episode took 3 hours. Felt like worst period cramping with fever on top of food poisoning. Next day was mildly nausea and sore, tired.
43 2021-02-09 feeling cold Patient got her 2nd covid shot on Thursday am. Felt fine Friday other then possibly a little achy an... Read more
Patient got her 2nd covid shot on Thursday am. Felt fine Friday other then possibly a little achy and totally fine Saturday. Felt somewhat fatigued Sunday afternoon. Woke early Monday am around 1am with sudden vomiting and diarrhea. Noted multiple loose stools and multiple episodes of vomiting and unable to tolerate eating or drinking. Also noted feeling cold. Noted feeling dizzy and lightheaded. Continues to feel achy. Came into Urgent care for fluids on Monday 2/8 and Tuesday 2/9.
43 2021-02-09 feeling jittery, flushing Lip tingling, throat tight, cough, flushing, jittery sensation
43 2021-02-09 flushing, feeling hot very flushed; perspiring; Feeling hot; Red face; chills; This is a spontaneous report from a contact... Read more
very flushed; perspiring; Feeling hot; Red face; chills; This is a spontaneous report from a contactable pharmacist reporting for herself. A 43-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacture Pfizer-BioNTech, lot# EL3249), via an unspecified route of administration, on 24Jan2021 at 14:30, at single dose, for COVID-19 immunisation. Medical history included endometriosis and migraine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included ibuprofen (MOTRIN) and unspecified oral contraceptives. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), on 04Jan2021 at 01:00 PM, in left arm, for COVID-19 immunisation. The patient experienced very flushed, perspiring, feeling hot, red face and chills all on 24Jan2021 at 15:00 with outcome of recovered after about 1 hour. Since the vaccination the patient has not been tested for COVID-19.
43 2021-02-09 muscle spasms Present to ER with SOB and coughing. Second COVID-19 vaccine was given at 10:30 am and she started f... Read more
Present to ER with SOB and coughing. Second COVID-19 vaccine was given at 10:30 am and she started feeling chills and cough about 2 hours later. Also, pt reported body aches and neck spasm. Patient given EpiPen as reports feels hard to breath, Solumedrol, Pepcid and Benadryl and reports sob resolved. Ptient watched for 2 hours, no return of symptoms, SOB resolved, and patient start eating and drinking and feeling well. discussed with patient use of Tylenol and Motrin for post vaccine aches and fever and follow up with employee health tomorrow. Patient discharge to home. Note: 1) patient doing well and get back to working the next morning (2/10/21) 2) Past medical history: Asthma and diabetes
43 2021-02-09 pain in extremity appx 2 hours after administration a headache and fatigue started that lasted appx 24 hours. Then, ap... Read more
appx 2 hours after administration a headache and fatigue started that lasted appx 24 hours. Then, appx 5 hours later, muscle aches and fever began (100.6) that lasted for about 24 hours. Also, immediate arm pain resulting in limited movement for appx 24-48 hours after vaccine administration.
43 2021-02-09 pain in extremity Arm was extremely sore; Felt very fatigued and achy; Felt very fatigued and achy; Stomach is still u... Read more
Arm was extremely sore; Felt very fatigued and achy; Felt very fatigued and achy; Stomach is still upset; Haven't felt like doing anything; Nausea; Abdominal pain; Threw up twice; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the right arm on 20Jan2021 (16:00) at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), spironolactone, fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC) and desogestrel, ethinylestradiol (MIRCETTE). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 30Dec2020 (when the patient was 43 years old) on the left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On the day of the vaccination, the patient was fine. The following day, 21Jan2021 (16:30), the patient's arm was extremely sore; she had felt very fatigued and achy; stomach was upset; and had not felt like doing anything. On 21Jan2021, at night, the patient had nausea, abdominal pain, and had threw up twice. The patient did not receive any treatment for the events. The outcome of the events, 'arm was extremely sore', 'felt very fatigued and achy', 'stomach was upset', 'had not felt like doing anything', 'nausea', 'abdominal pain' and 'threw up', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination. Information on the lot/batch number has been requested.
43 2021-02-09 tingling Client received her first dose of Pfizer vaccine and towards the end of the 15 minutes post-vaccinat... Read more
Client received her first dose of Pfizer vaccine and towards the end of the 15 minutes post-vaccination wait time she said she felt ?tingly.? She denied any itching, rash or difficulty breathing. She also stated: ?it is not necessary to call 911.? Her vital signs were as follows: BP=128/86, Pulse=75, Respiration=16. She wanted to leave and was asked to call 911 if she later had any symptoms, to which she voiced understanding.
43 2021-02-10 weakness Headache, chills, body aches, Muscle pain, weak, sweats
43 2021-02-10 migraine Nausea, extreme fatigue, migraine
43 2021-02-10 muscle twitching Muscle soreness at injection site; Muscle soreness at injection site; left bicep muscle twitching fo... Read more
Muscle soreness at injection site; Muscle soreness at injection site; left bicep muscle twitching for about 1-2 minutes at around midnight; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN5318, on 26Jan2021 07:00 at single dose in left arm for Covid-19 immunization. Medical history included high blood pressure, allergies to penicillin and amoxicillin. Concomitant medications included amlodipine besilate (NORVASC), atorvastatin (LIPITOR), pseudoephedrine hydrochloride (SUDAFED), VITAMIN D NOS, and cetirizine hydrochloride (WAL ZYR). The patient was not Pregnant at the time of vaccination. The patient had no any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Muscle soreness at injection site that was still occurring but lessened 24h later and left bicep muscle twitching for about 1-2 minutes at around midnight. No treatment was received for all events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The outcome of all events was resolving.
43 2021-02-10 tingling felt like she was going to pass out; face started to tingle/tingling returned but this time it was d... Read more
felt like she was going to pass out; face started to tingle/tingling returned but this time it was down her chest; lips started going numb; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiry date: unknown), via an unspecified route of administration, in the right arm, on 27Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. The patient is not pregnant. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 27Jan2021, after getting the vaccine, the patient experienced face started to tingle and felt like she was going to pass out. On 27Jan2021, vitals were taken and showed normal. The patient reported that on her way home on 27Jan2021, lips started going numb and the tingling returned but this time it was down her chest. Therapeutic measures were taken as a result of all the events which included diphenhydramine (BENADRYL). Outcome of all the events was recovered on unspecified date in Jan2021.
43 2021-02-11 burning sensation After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling gre... Read more
After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling great, Thursday evening I developed burning and itchy hives all over my neck chest and face, my face appeared swollen, I also had a smaller outbreak on my legs I took benedryl which seemed to calm the reaction some when I woke up the following morning, and another dose seemed to calm it some more
43 2021-02-11 facial paralysis Sudden onset right side facial paralysis
43 2021-02-11 feeling cold, discomfort, feeling hot At 5:22 pm patient reported to nurse that she was feeling "sleepy", lightheaded, and "cold" after sh... Read more
At 5:22 pm patient reported to nurse that she was feeling "sleepy", lightheaded, and "cold" after she recieved her first dose of Pfizer BioNTech COVID-19 vaccine EUA. Viitals taken every 5 minutes. Patient then reports that she is feeling heavyness in her body, nausea, and started to feel "warm coming from the inside." 5: 45pm Administered 50 mg of Benadryl by mouth. Patient initially declined meds. Monitored patient for one hour. Patient was alert and oriented and left clinic with her friend.
43 2021-02-11 feeling hot, pain in extremity Tachycardia, legs burning hot, , temp was 99.4, body aches including hip pain for 36 hours. Arm pa... Read more
Tachycardia, legs burning hot, , temp was 99.4, body aches including hip pain for 36 hours. Arm pain as well. Today, I was seen in Urgent Care, and now have Shingles.
43 2021-02-11 numbness Within one minute of receiving the shot my throat felt like it was swelling and I had difficulty swa... Read more
Within one minute of receiving the shot my throat felt like it was swelling and I had difficulty swallowing. Lasted about 30 minutes. Two days later my right leg felt dead and big, similar feeling to when I had a spinal for a cesarean section. The sensation was off and on for 2 days and then subsided.
43 2021-02-12 discomfort chest pain in the center of my chest, and tightness in my chest following my second shot. Lasted app... Read more
chest pain in the center of my chest, and tightness in my chest following my second shot. Lasted approximately an hour. Only lessened by laying down. I've never had this kind of pain/discomfort before, so I attribute it to the shot. I considered going to the ER. Other than the chest pain, the only other reaction I had following the second shot was sore arm.
43 2021-02-13 migraine, pain in extremity Days 1 & 2 experienced arm soreness. Days 3-5 experienced daily headaches that turned into migraines... Read more
Days 1 & 2 experienced arm soreness. Days 3-5 experienced daily headaches that turned into migraines (on days 4 &5); pain in left wrist; pain in upper arm (below injection area), pain in left shoulder socket (joint pain), and pain in left arm pit (experienced these issues all day long). Day 6 only experienced pain in left wrist and pain in left shoulder socket (joint pain).; experienced both all day long. Day 7 and so forth have no experienced any further issues.
43 2021-02-14 tingling Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunothe... Read more
Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunotherapy. Pt presented with rash/itching on chest, tingling around ears and runny nose 20 minutes after vaccine administered.(0828) Doctor notified and Benadryl 25mg PO given VS at time 169/98, 60, 100%. 0847 pt c/o slight chest tightness, slight labored breathing, feeling of periorbital swelling,VS at time 173/91, 51, 99% Doctor again notified and an RN stat called, pt taken to the ER and report given to ER RN, pt appeared to be comfortable and feeling somewhat better
43 2021-02-15 flushing Facial flushing, asthma, blurred vision
43 2021-02-15 hot flush Patient states to get an itchy face and felt flush with chest heaviness. She was provided a Benadryl... Read more
Patient states to get an itchy face and felt flush with chest heaviness. She was provided a Benadryl and monitored for 30 minutes and was better after administration of the benadryl
43 2021-02-16 burning sensation, numbness PATIENT CALLED AT 9AM 2/17 NUMBNESS TO FINGERS, VEINS IN HANDS EXPOSED AND SWOLLEN. BURNING SENSATIO... Read more
PATIENT CALLED AT 9AM 2/17 NUMBNESS TO FINGERS, VEINS IN HANDS EXPOSED AND SWOLLEN. BURNING SENSATION TO HANDS. REDNESS TO UPPER LEFT ARM.
43 2021-02-16 pain in extremity A few hours after the vaccination I had a lesion form on the back of my left leg, moderate pain from... Read more
A few hours after the vaccination I had a lesion form on the back of my left leg, moderate pain from the left hip to the back of the left knee. I sought treatment from my PCP within 24hrs and was prescribed an antiviral med. The symptoms subsided after starting the med and no new symptoms has arised.
43 2021-02-16 tingling 4 days with increased heartbeat and blood pressure under the normal values, with shortness of breath... Read more
4 days with increased heartbeat and blood pressure under the normal values, with shortness of breath and dizziness. Felt tingling on left arm and face. Also bone pain and tiredness extreme.
43 2021-02-17 flushing, feeling hot EE reports getting her second Covid (Pfizer) vaccination at 11 AM on 02/16/2021. With having concern... Read more
EE reports getting her second Covid (Pfizer) vaccination at 11 AM on 02/16/2021. With having concerns of her throat feeling "hot" for about six hours after her first vaccination, EE pre-medicated with Allegra and Pepcid prior to the second vaccination. EE reports that within 20 minutes after the second vaccination her throat got hot and felt swollen, so she took Benadryl. Between 1900-1930 that same evening EE reports that her throat felt like it was tightening up, so she went to acute care. EE was given Solumedrol IM, Decadron orally, Benadryl 50 mg, and Pepcid. EE states that her HR was in the 140's, and she was flushed at this time.EE reports that she is now on a 10 days course of Prednisone, Zyrtec for 2 weeks, and Benadryl prn.
43 2021-02-17 numbness, tingling Received Pfizer dose#2 02/17/21 and shortly after developed numbness and tingling in the Left upper ... Read more
Received Pfizer dose#2 02/17/21 and shortly after developed numbness and tingling in the Left upper and lower extremities, chest pressure, dizziness and acute HTN.(180/110).
43 2021-02-17 pain in extremity Vominting within 1 hr of vaccine. Extream arm pain. Temp of 102. Hallucination with extream chills a... Read more
Vominting within 1 hr of vaccine. Extream arm pain. Temp of 102. Hallucination with extream chills and body aches.
43 2021-02-18 weakness Chills began at 10 pm. Fever at 101.5. Back and neck pain. Headache. Morning 2/17/21 could not get o... Read more
Chills began at 10 pm. Fever at 101.5. Back and neck pain. Headache. Morning 2/17/21 could not get out of bed. Extreme weakness, joint pain, back and neck pain, swollen gland under left armpit, pain, headache, fever up to 102.5. 2/18/21 low grade temp. 99.9. joint pain, headache. Used Tylenol, 2 pills every 4 to 6 hours.
43 2021-02-18 concussion A couple days after the vaccination I blacked out completely with no warnings signs or symtoms. I h... Read more
A couple days after the vaccination I blacked out completely with no warnings signs or symtoms. I had a head contusion and consuccion resulting in a few stitches in my head. Several test were ran but all were normal.
43 2021-02-18 numbness, weakness, cold extremities I had Covid from March 14, 2020- April 1, 2020. I treated positive for antibodies in May 2020. I r... Read more
I had Covid from March 14, 2020- April 1, 2020. I treated positive for antibodies in May 2020. I received the first vaccine on 2/14/21 around 4:55 pm. 2/15-I awoke at 7am: sweating, headache, body aches/ pinging type sensation, fatigue, pain across my chest , no trouble breathing though. These are the same symptoms I had when I had Covid. 2/16 I was able to get out of bed, run errands, but still have headache, still feel achy, haven?t noticed a fever but I have had moments of sweating like one broke. Lymph nodes under my left arm are swollen and painful to touch. 2/17lymph nodes still very large and swollen, pings of 2/18: fatigue, weakness, 11pm- right arm became cold and numb like it was asleep, pinging muscle aches or more accurately pains where lymph nodes are located. Body seemed swollen overall too. 2/19: right arm and uncle still swollen and heavy Groin lymph area right side is painful today.
43 2021-02-18 migraine, pain in extremity pain in left arm (similar to getting a flu shot; like someone punched my arm), full body ache, chill... Read more
pain in left arm (similar to getting a flu shot; like someone punched my arm), full body ache, chills, migraine; lasted the entire day
43 2021-02-18 pain in extremity Within 5-10 minutes of injection initial sense of fullness in throat, throat clearing, mild difficul... Read more
Within 5-10 minutes of injection initial sense of fullness in throat, throat clearing, mild difficulty swallowing. No visible swelling. At 35 minutes after injection attempted to drink water, difficulty swallowing, coughing, no visible swelling. At 45-50 minutes post vaccine attempted to eat dinner (black beans and rice) difficulty swallowing, coughing. Again no visible swelling. Took Benadryl waited 15 minutes, able to eat dinner - resolved Other not resolved: Left arm pain referring up to neck and generalized swelling (loose shirt sleeve on Right is snug over left arm) , itchy ears
43 2021-02-19 migraine At onset extreme fatigue, terrible migraines and constant nausea. As of today, fatigue has finally s... Read more
At onset extreme fatigue, terrible migraines and constant nausea. As of today, fatigue has finally subsided. However, extreme migraines and constant nausea are not going away!!
43 2021-02-19 pain in extremity 8 hours after the shot= all my joints hurt. Joints that normally do not hurt did like my neck joint,... Read more
8 hours after the shot= all my joints hurt. Joints that normally do not hurt did like my neck joint, right wrist joint. The joints that do normally hurt were way worse (my back, and right big toe joint). There was a pain in my right eye, and that eye had blood vessels burst in it. 36 hours after the shot= started bleeding from my vagina. My last menstruation was 2 weeks ago and this is VERY unusual for me. Normally my periods are 30-32 days apart.
43 2021-02-21 pain in extremity On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on... Read more
On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on the tissue. This happened a second time and then it was finished. I felt really tired and not myself. Then later that night my arm began to hurt so bad that I could not lift it. I began to rub the area that was hurting and noticed that I now had a nice size lump there . I took a Tylenol 500mg and a hot shower. When I woke up the next morning my arm was still hurting but not as bad. When I went to use the bathroom I had began to start spotting again. This continued throughout the day and now I am bleeding as if I was having my period. I am super tired. It is to the point that i cant function at work.
43 2021-02-21 pain in extremity Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. res... Read more
Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. resolved. over the next few days. patient reported increased fatigue and SOB. advised patient to seek medical attention for symptoms which she did today. reports she has now left sided chest discomfort. and left arm pain.
43 2021-02-22 bell's palsy, facial paralysis Within two hours of injection, headache and fever symptoms with body aches for appoximately 56 hours... Read more
Within two hours of injection, headache and fever symptoms with body aches for appoximately 56 hours. Approximately 40 hours after injection, noticable drooping of right side of face, which resolved 90% after 24 hours; doctor assessment was that this was likely a temporary case of Bell's Palsy.
43 2021-02-22 discomfort, feeling hot at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and f... Read more
at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and felt warm. States she started feeling pressure and warmth to her face with some itching. At 1500 she came to employee health. RN gave her 25 mg liquid benadryl. Her BP was 126/89, HR 87. No hives or swelling to Right arm noted. BP 117/80, HR 75. at apprx 1520, bp 137/85, HR 67. No other signs or symptoms noted. 1528, bp 121/82 At 1532, "patient states she feels good, almost back to normal".
43 2021-02-22 facial paralysis Drooping eye and mouth on left side of fave
43 2021-02-22 numbness numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; ... Read more
numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; menstral cycle thrown off by 10 days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: not available/provided to reporter at the time of report completion), intramuscular, Left arm on 06Jan2021 13:45 at single dose for covid-19 immunization. Age at vaccination was 43 years. Patient was not pregnant at the time of vaccination. Medical history included Hoshimotos and Acid reflux. Allergies to medications, food, or other products included sulfa allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included omeprazole 40mg, paroxetine 20mg. On 06Jan2021 14:00, the patient experienced swelling and itching of tongue and lips within 15 min, numbness of face the next day (on 07Jan2021) continuing for several weeks. Menstral cycle thrown off by 10 days. The events resulted in emergency room/department or urgent care. Recovered with lasting effects. Benadryl, pepcid and prednisone treatment was received for the events. Events outcome was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relationship, the association between the vaccine and the events swollen tongue, lip swelling, tongue pruritus, lip pruritus, hypoaesthesia cannot be completely excluded. Delayed menstruation is probably an intercurrent condition for which the patient's age is also a contributing factor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
43 2021-02-23 weakness, tenderness Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and ... Read more
Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and into breast, bruising and tenderness. 2/20/21 to current Nausea and diarrhea 2/20/21 to current Exhaustion 2/20/21 to current
43 2021-02-23 weakness, tremor, discomfort Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
43 2021-02-23 discomfort Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe
43 2021-02-23 flushing Became lightheaded/faint and had facial flushing. Unable to stand up for fear of syncope.
43 2021-02-23 night sweats Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely ... Read more
Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.
43 2021-02-24 weakness A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vacc... Read more
A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and feeling weak. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: anxiety and bipolar. Takes Aripiprazole for this. No other medical history reported. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded), Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, joint pain and headaches. Previous Reactions: none. Vitals -- 02/19/21 0350 02/19/21 1610. BP: 131/77 125/77. Pulse: 89 75. Resp: (!) 22 16. SpO2: 100% 100% Physical Exam--Vitals and nursing note reviewed. Constitutional -- General: She is not in acute distress. Appearance -- Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal -- Cervical back: Neck supple. Skin -- General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological -- General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time; Gait: Gait normal. Psychiatric -- Mood and Affect: Mood is anxious; Behavior: Behavior normal; Thought Content: Thought content normal; Judgment: Judgment normal. Assessment/Plan -- Treatment included: water and snacks. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP; Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health). Pt aware of monitoring symptoms at home. Follow up as needed with pcp. Recommend that she eat a snack and hydrate prior to next vaccine #2 of Pfizer.
43 2021-02-24 weakness Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiv... Read more
Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiving vaccine, pt developed shoulder and neck pain. She felt feverish, chills that night but did not check temperature. Over next few days, she developed increasing generalized body aches, joint aches, headaches, weakness, fatigue. On 1/21/21 pt noted SOB and chest tightness, so she reported to ED. She checked her pulse ox and was 99%, was tachycardic to 140-150. She takes propranolol for essential tremor, so she took propranolol 40 mg PO x 1 and presented to ED on 1/21/21. In ED, pt was no longer tachycardic. Pt also states her concern for blood clot (mother had DVT in her 30s). She presented with moderate chest pain and tightness, as well as headache, weakness, SOB. Pt given APAP 1000 mg PO x 1, ibuprofen 800 mg PO x 1, orphenadrine 100 mg PO x 1. Nitroglycerin 0.4 mg SL x 1 ordered, but not given on MD's orders. Pt discharged home. 1/22/21: Pt f/u with hospital. DO says her elevated WBX and Cr were likely d/t vaccine and dehydration. DO offered to schedule f/u BMP and CBC on Monday 1/25. Pt also scheduled for outpt fluids at infusion center on Monday 1/25 in case BMP and CBC still indicate dehydration.
43 2021-02-24 bell's palsy, numbness Bell's Palsy right side of face. Right upper eyelid droop, righ cheek numbness on palpation, slight ... Read more
Bell's Palsy right side of face. Right upper eyelid droop, righ cheek numbness on palpation, slight smile effected/off from left, no ringing in ear, able to raise eye brow. Mental status WNL, able to hold conversation, made proper eye contact.
43 2021-02-24 feeling hot About 45 to 50 minutes after vaccine was administered body and face felt warm and face was itching f... Read more
About 45 to 50 minutes after vaccine was administered body and face felt warm and face was itching for the rest of the afternoon. 02/23/2021 itching of face and genitals. 02/24/2021 mild rash appeared on hands and face and continues to itch. Advised to take Benadryl or Claritin to help the itch.
43 2021-02-24 tenderness Extreme shooting pains left side of head. Tenderness above ear. Left eye pain. Lethargic. Neck pain.... Read more
Extreme shooting pains left side of head. Tenderness above ear. Left eye pain. Lethargic. Neck pain. Muscle pain.
43 2021-02-24 tremor About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt lik... Read more
About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt like I was wheezing. Super shaky and dizzy. I gave myself my epi-pen. I notified them and they took me to ER - IV - Benadryl and Solumedrol . I got really shaky for about an hour afterwards and then they discharged me. It cleared up my throat issues. within 4 days, I had significant shortness of breath again and I was directed to ER Gave me evaluated me for a pulmonary embolism - I did not have one. They gave me Solumedrol again. They gave me a prednisone taper. And then a week after that - or two weeks after - the shortness of breath returned - Dr had me go to ER room again - They gave me another prednisone taper which I'm still on and I have significant fatigue still and 24/7 out of breath still. Currently: Flonase 50 mg - twice a day - Admerdiscus 100 mg - twice a day
43 2021-02-25 weakness Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spon... Read more
Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spontaneous report from a contactable nurse (the patient). This 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), dose 2, single dose via an unspecified route of administration in the left arm on 26Jan2021 at 10:00 AM (at the age of 43- years-old) for COVID-19 vaccination. The patient's medical history included hypertension, hyperlidemia, pre-cancer cells in cervix, hysterectomy and allergy to penicillin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ELO1423, expiration: 1/2021), single dose, dose 1 in the right arm on 05Jan2021 at 10:00 AM. Concomitant medications included atorvastatin, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), fluoxetine (PROZAC) and zolpidem (AMBIEN). On 27Jan2021, the patient had neck, back and chest pain, dizzy, weak and fever. The events were reported as non-serious. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. No therapeutic measures were taken as a result of neck, back and chest pain, dizzy, weak and fever. The clinical outcome of neck, back and chest pain, dizzy, weak and fever was not recovered . The patient has been tested for COVID-19 since having the vaccine. On 25Jan2021, COVID rapid test was negative.
43 2021-02-25 numbness, tingling Sharp pins and needles feeling in the palm and fingers of left hand. Numbness of left hand/figerpad... Read more
Sharp pins and needles feeling in the palm and fingers of left hand. Numbness of left hand/figerpad. +Paresthesias.
43 2021-02-27 weakness Although I felt nothing during the first dose, I DID feel a prick for my second dose. It was followe... Read more
Although I felt nothing during the first dose, I DID feel a prick for my second dose. It was followed by a little itch, but nothing unusual. I made sure to rub my arm and keep it moving until I went to bed a couple of hours later. The next day, I woke up with no issues, just a slight tenderness at the injection site that only really hurt if I touched it. At about 9:30 am, almost 12 hours after the second dose, I became a bit tired, had a little chill, and was a tiny bit achy. I took two Tylenol, and continued to hydrate. I could feel myself getting more uncomfortable as the day went on. By 3:00 pm, I was freezing, could not get warm, and running a fever of 100. I took more Tylenol, and got bundled up and took a nap. At 4:00 pm, I woke up and was even colder, and had a fever of 102.4. At this point, I got into bed and had continued to hydrate and take ibuprofen (I had run out of Tylenol) every four hours. The fever broke at some point in the night, as I woke up and was soaking wet, but by the time I woke up the fever had returned and was 101. I took more Ibuprofen and the fever dropped back to normal around noon on February 18. By far, the worst feeling, aside from the fever, was the extremely severe joint pain I had in my ankles, knees, hips, arms, and hands. It was painful to stand and to walk. By Friday, I felt better, but was weak. I felt back to 100% on Saturday morning.
43 2021-02-27 tingling, feeling cold Approximately 25 minutes after injection, patient reported a scratchy throat, headache, bilateral ar... Read more
Approximately 25 minutes after injection, patient reported a scratchy throat, headache, bilateral arm tingling, cold sensation, difficulty swallowing. MD at chairside, given Benadryl and Tylenol orally. Patient continued to have cold sensation, chilling and difficulty swallowing without water. MD ordered an additional dose of oral Benadryl. After approximately 2-3 hours of observation, patient was discharged home with spouse in no apparent distress.
43 2021-02-28 pain in extremity Day 1: Arm hurt 6/10; Day 2-3: Pain 10/10 unable to move arm; Day 4-5: T-Rex arms only. Otherwise 10... Read more
Day 1: Arm hurt 6/10; Day 2-3: Pain 10/10 unable to move arm; Day 4-5: T-Rex arms only. Otherwise 10/10 pain in upper arm. Day 6-12: pain decreasing and regain mobility. Day 13-14: No improvement; Day 15-present increased pain.
43 2021-03-01 inability to speak I received shot 1 of the Pfizer-BioNTech mRNA vaccine on 2/17/2021. IMMEDIATELY afterward, I had a ... Read more
I received shot 1 of the Pfizer-BioNTech mRNA vaccine on 2/17/2021. IMMEDIATELY afterward, I had a headache and dizziness and brain fog (including trouble forming sentances and forgetting words). These symptoms have persisted every day since the vaccine. These symptoms have diminished slooooooowly over the past 14 days but are still present today.
43 2021-03-01 flushing Lightheaded, blurred vision, flushed feeling, shaky, tightness in neck, diaphoretic. Evaluated by E... Read more
Lightheaded, blurred vision, flushed feeling, shaky, tightness in neck, diaphoretic. Evaluated by EMS. 1:09PM -Jaw slightly tight. 1:20 pm pain, stiffness traveling to mid back. 1:25 pm neck feeling better, no nausea, tinling in hands, no change in sensation in legs. 1:30pm remains lightheaded, vision remains blurry, c/o left sided chest discomfort when pressure applied, pain and stiffness in neck returning. 1:42 pm transported to Hospital by rescue squad.
43 2021-03-01 migraine Severe prolonged migraine headache after dose -- timed immediately after injection
43 2021-03-01 pain in extremity Sorry arm, nausea, chills, cough, fatigue, light headed, dizziness
43 2021-03-01 tingling Tingling like sensation/left forearm/arm, headache. Evaluated by EMS-Cleared
43 2021-03-02 pain in extremity, tenderness Pain in left elbow and in anterior muscle from elbow to mid arm. Started day after receiving second... Read more
Pain in left elbow and in anterior muscle from elbow to mid arm. Started day after receiving second COVID vaccine. Bruise remains at injection site, lite purple and tender to touch.
43 2021-03-03 numbness, severe one side paralysis eight minutes after the vaccine I was waiting for my after dose evaluation, I started feeling numbne... Read more
eight minutes after the vaccine I was waiting for my after dose evaluation, I started feeling numbness on left side of my face, I was taken to the ER, it went down to the left side of my neck and my left arm, after an hour I couldn't move the entire left side of my body, they did an MRI and admitted me to overnight observation. next morning I was discharged (friday), physical therapy and occupational therapy came in to help me adjust because I was still numb I was given a walker and a knee brace, I went home. Saturday I started getting feeling in my face and neck. Sunday I was still gaining more sensation, Monday I had full sensation every where except my leg, Tuesday I had complete feeling on my entire left side. 7 days after my shot on wednesday I started having cold chills body aches and fever nausea and diarrhea, by thursday I couldn't eat anything in me I would have diarrhea. I went to the ER on Saturday, they ran tests CT scan and found entera colitis and was admitted again, they started me on iv antibiotics and fluids , no solid food, they tested my stool and everything came back normal. I was discharged because the diarrhea had stopped, I was having regular bowl movements. Dr said it may or may not have been a cause from the vaccine, they weren't sure.
43 2021-03-03 numbness, tingling patient reports the first few days she experienced numbness ad tingling (2/12-2/15) to bladder and b... Read more
patient reports the first few days she experienced numbness ad tingling (2/12-2/15) to bladder and bilateral feet, around 2/18 her entire neck began to feel inflamed and she is still experiencing this, the neck inflammation is causing pain at a level 4 on the pain scale. Had visited the chiropractor with minimal reduction in symptoms. Has had some abdominal pain that is still present, began around 2 weeks post vaccine, this pain varies in location and is described as short lived shooting pains.
43 2021-03-03 muscle spasms Sweats, nausea, muscle spasms in the injected arm for 24 hours. Spasms went away and came back a co... Read more
Sweats, nausea, muscle spasms in the injected arm for 24 hours. Spasms went away and came back a couple of days later and have continued off and on. On 3/3/21 a mild fever and on 3/4/21 "covid arm" at the injection site. It is red, very itchy and hard and swollen.
43 2021-03-03 night sweats, migraine 10:15 am Started to sweat,10:25 am Started to have the chills (chills and sweats traded off througho... Read more
10:15 am Started to sweat,10:25 am Started to have the chills (chills and sweats traded off throughout the day and night),11:30 am migraine began to progressively get worse and continued throughout the day, 12:00 pm became slightly nauseous ate a little bit of food and it helped. Nausea gone by 12:.35 pm, (progressively slightly more fatigued than normal lasted for 2 days). Night sweats and chills throughout the night and migraine lasted until Thursday.
43 2021-03-05 tingling, nerve pain 5 min after vaccine: nerve pain in upper right arm traveled in a line into right side of neck, up to... Read more
5 min after vaccine: nerve pain in upper right arm traveled in a line into right side of neck, up to just below the ear. Pain traveled directly from site of vaccine in arm and up through neck. 10 min after vaccine: Nerve pain down began in a line down right arm and into pinky and ring fingers of right hand. 20 min after vaccine: Tongue tingly (entire right side only, left side normal), pain in jaw, headache beginning in right temple. OTC Tylenol and then Ibuprofen taken 1 hour, 15 min after vaccine helped dull headache but not other symptoms. Nerve pain was intermittent until bedtime. The next morning, woke to right eye crusty from tearing, right eye tearing at corner (clear, like tears), consistently drippy right nostril (clear), loss of taste in tingly right side of tongue (could taste on left side of tongue), tingly right side of lips, slight drool right side mouth, outside of ear slight tingly. Headache returned, only in right temple extending to above right eye. Right side of face felt heavier than left side. Sensitivity to light, sound. Took Tylenol and Ibuprofen. Over 9 hour period (24-28 hours after vaccine given), most symptoms resolved, including taste. The next day (48 hours after shot), symptoms remaining are right eye has very slight tearing, right side of face feels a little "heavier" than left side, but drastically different from day before. I have NEVER had anything like this happen before after a vaccine or otherwise.
43 2021-03-06 tenderness, pain in extremity 2/26/21-3/1/21 left ear pain as if a pimple is inside 3/1/21-3/5/21 Left big toe and two toes next t... Read more
2/26/21-3/1/21 left ear pain as if a pimple is inside 3/1/21-3/5/21 Left big toe and two toes next to it painful, itchy, hurts when push on toenails, awoken from sleep needing Tylenol Both got better without medical treatment.
43 2021-03-07 feeling hot Dizzy, nausea, felt warm. BP 171/114 (pulse 100), then 151/93. 98% O2 sat. Given juice, water, and r... Read more
Dizzy, nausea, felt warm. BP 171/114 (pulse 100), then 151/93. 98% O2 sat. Given juice, water, and rested.
43 2021-03-07 pain in extremity Sore arm
43 2021-03-08 flushing About Ten minutes after the shot my face became very flushed and I felt light headed. I had a strang... Read more
About Ten minutes after the shot my face became very flushed and I felt light headed. I had a strange swelling feeling around the backsides of my tongue, like the numbing feeling after a dentist visit. Then about 15 or 20 minutes later someone noticed a red slightly bumpy rash on my chest below my neck. It did not progress. I took Benadryl about 40 minutes after my shot and the rash and tongue feeling went away. I took Benadryl again 6 hours later . After that I had a mild headache and fatigue for two days. With some occasional nausea that would come and go for three days.
43 2021-03-08 numbness, pain in extremity, tingling 104 constant fever 3 days with first vaccine; 4 days with second vaccine; Severe back pain and stiff... Read more
104 constant fever 3 days with first vaccine; 4 days with second vaccine; Severe back pain and stiffness unresolved and ongoing (now on day 7); arm swelling at injection site with second vaccine - hard knot the size of a small egg, hot to the touch, bright red coloration - unresolved and ongoing (day 7); numbness of the left arm, left side, and left leg - second vaccine- ongoing and unresolved (day 7); pain, tingling varying with numbness of the left hand and finger and left foot and toes- second vaccine - ongoing and unresolved (day 7); extreme fatigue - both vaccines - ongoing and unresolved (day 7); vomiting and nausea - unable to keep down solid food, can keep down cold liquids but nothing warmer than room temperature - ongoing and unresolved (day 7) recommendation to see PCP for referral to neurologist, immunologist as soon as possible.
43 2021-03-08 numbness Patient had numbness in the left leg, few minutes after vaccine administration. The numbness disappe... Read more
Patient had numbness in the left leg, few minutes after vaccine administration. The numbness disappeared 30 minutes after she made the complaint. We monitored her further for another 30minutes, and she was fine, so no further intervention.
43 2021-03-08 tingling Around ten minutes post injection PT experienced tingling throughout body, slight constriction in th... Read more
Around ten minutes post injection PT experienced tingling throughout body, slight constriction in throat, lungs clear throughout no wheezing, BP: 138/89, o2 saturation: 98%, HR: 89 PT then developed facial swelling , administered benedryl at 1815 PO, constriction continued as well as facial swelling post medication admin. PT declined Epi-Pen recommendation. At 1830 an addition PO administered, no change in PT condition. Decision to contact EMS at this point, Medic responded to the scene where patient was sent to hospital.
43 2021-03-08 tenderness, pain in extremity Started out as being light headed and tired. Then the next day noticed arm red and very sore. I watc... Read more
Started out as being light headed and tired. Then the next day noticed arm red and very sore. I watched it and monitored it. Then on the 8th I woke up to the red spot being bigger, warm to touch and very sore. I marked it with a pen to keep track of the red spot spreading. I took an Ibuprofen at night and put ice on the spot. Today on the 9th the red spot has spread a little, however the redness of the color has gotten lighter. It is still tender to the touch and the spot is still warm to the touch. I am going to continue to monitor it another day or two and if it gets worse I will call my doctors office to make a visit
43 2021-03-09 weakness Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemi... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
43 2021-03-09 facial paralysis, pain in extremity tired; sore arm; Facial droop (left eye and mouth); This is a spontaneous report from a contactable ... Read more
tired; sore arm; Facial droop (left eye and mouth); This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at left arm 23Feb2021 08:00 at single dose for covid-19 immunisation. Medical history included Known allergies: Sulfa drugs, codeine, diastolic dysfunction type 1 from Jul2020, and anxiety depressive disorder (she took a medication for that and it had been diagnosed more than ten years). Concomitant medication included bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). The patient experienced facial droop (left eye and mouth) on 23Feb2021 14:30, tired and sore arm on an unspecified date. The clinical course was as following: She said her appointment for the vaccine was at 08:00AM, and around 02:30PM she was in a video meeting and her left side of her face started to droop and her coworker messaged her to ask if she was ok since she looked pretty funny with the eye and mouth droop. She said that this droop lasted about 4 hours and by 06:30PM it was mostly resolved, if she was not looking at it or trying to raise her eyebrows. She said that the only other side effects were she was tired and had a sore arm. She said doctor asked her to got to the emergency room (ER) to rule out a stroke or transient ischemic attack (TIA) so they did a couple of Computerised tomogram (CT) scans, one with contrast and one without, and a MRI and they did full blood lab work up, and did an Electrocardiogram (EKG) to rule out central nervous system events. She says that they didn't think it was a TIA, they felt it was a peripheral nervous event related to an autoimmune response and all the tests said that they did not thought she had TIA event. She said doctor said it was likely an auto immune response to receiving vaccine, since there were no intervening events between getting the vaccine and the droop, she has not been sick or had any dental events recently. the main reason she was calling was to see if she should get the second dose, since she wanted to get it but has heard the side effects can be stronger for the second dose. She says she would like to know can she or should she take it. The patient was tested was for a stroke but that test came back negative. The patient would like to know if it is contraindicated for her to receive the second dose after having this reaction. The outcome of the event Facial droop was recovering, and the outcome of the event tired and sore arm was unknown.
43 2021-03-09 flushing 44 y.o. female AAO x4. PT had vaccination admin at 1250 hours, summonsed medic in observation area f... Read more
44 y.o. female AAO x4. PT had vaccination admin at 1250 hours, summonsed medic in observation area for a scratchy throat. PO Benadryl administered PTA 25 mg. Medical lead went to parking lot and pt. was having a hoarse cough with worsening, starting to get flush in face. ED summonsed via 911. . Pt. then started to have episode of emesis. 0.3 mg epi 1:1000 ordered to be administered, medication was drawn up, verified, and administered to left deltoid. Arrival of ED on scene, hand off given pt. transported to hospital. Allergies PCN. no hx anaphylaxis no reaction to first dose of pfizer covid-19 vaccination. Vitals BP 132/94, pulse rate 94, R 20. Pt. was contacted 1943 hours on 3.10.21 Pt. had stay in ER approximately 5 hours, was discharged home with epi-pen, and an unknown antihistamine. Pt. will follow up with PCP about anaphylactic reaction she had today.
43 2021-03-09 pain in extremity small red welt appeared at injection site; small red welt appeared at injection site; arm pain retur... Read more
small red welt appeared at injection site; small red welt appeared at injection site; arm pain returned; arm pain at site of injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9262), via an unknown route of administration on 29Jan2021 at 17:00 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported (did not have other medications in two weeks). The patient did not receive other vaccines within 4 weeks prior to vaccination. On 29Jan2021, the patient initially experienced arm pain at the site of injection; on 06Feb2021 at 08:00 (day 8 post vaccination) the patient experienced a small red welt at the injection site and arm pain returned. The patient did not receive any treatment for the events. The clinical outcome of the event vaccination site pain was recovered within approximately 36 hours; vaccination site erythema and vaccination site reaction was resolved on day 9; and pain in arm was recovering.
43 2021-03-09 tingling Patient returns to vaccine location two hours after vaccine, stating within minutes she had sensatio... Read more
Patient returns to vaccine location two hours after vaccine, stating within minutes she had sensation of tingling on the left side of her face and tongue. No other symptoms. Vaccine clinic was closed for the day, encouraged to seek care at an acute care. Confirms understanding.
43 2021-03-10 migraine, feeling of body temperature change Have cold and hot sweat, migraine, body ache
43 2021-03-10 tingling Bruise & rash on left arm, below injection site- started 2 days after injection, getting better afte... Read more
Bruise & rash on left arm, below injection site- started 2 days after injection, getting better after 2 days Dizziness - starting 4 days after injection Face tingling - starting 5 days after injection
43 2021-03-10 tremor "3/6/21 9 pm, had shakes, chills, fever, brain fog, fatigue."
43 2021-03-11 feeling hot Warmth feeling Intense Headache Dizzy
43 2021-03-11 migraine Already suffer from migraines. Friday started as headache turned migraines and continued to today. O... Read more
Already suffer from migraines. Friday started as headache turned migraines and continued to today. On Wednesday stomach started hurting, by Thursday left work early due to severe stomach pains that stayed for long time then went away & returned. Today tummy still hurts, pooping often but not diarrhea, and head is pinging
43 2021-03-11 migraine vomiting and migraine
43 2021-03-11 tingling, numbness Patient was having heaviness in left arm after receiving vaccination checked vitals BP was elevated ... Read more
Patient was having heaviness in left arm after receiving vaccination checked vitals BP was elevated at 175/128, one minute late they checked again it was 184/109. Patient reported that heaviness on left side was getting worse. Nurse working the clinic got a wheelchair and took patient to Emergency Room. While they were on the way to the ER, patient started complaining of numbness and tingling down left side of arm.
43 2021-03-12 pain in extremity left arm is swollen and painful then it started hurting in my armpit and my lymph node underneath m... Read more
left arm is swollen and painful then it started hurting in my armpit and my lymph node underneath my arm pit is swollen. Also had body aches and head ache through the night. That is better but the swollen arm and lymph node is not
43 2021-03-13 discomfort shaky, heaviness. Evaluated by EMS-Cleared
43 2021-03-13 tingling Face swelling (cheeks,, lips, eyes); Scratchy throat; Lips and face tingling; Heavy tongue.
43 2021-03-13 throat numbness Numbness and tingling in throat and tongue.
43 2021-03-14 pain in extremity Entire arm from shoulder to fingers extremely swollen. Unable to close hand and painful.
43 2021-03-15 weakness, flushing signs/symptoms, not sure if true adverse event: had a taste in my mouth immediately after receiving... Read more
signs/symptoms, not sure if true adverse event: had a taste in my mouth immediately after receiving first dose. Two days after first dose: heart rate increased to 130's resting, systolic blood pressure increased to 140's resting, (usual heart rate 70's-90's, usual systolic blood pressure 110's-120's), dizziness, headaches, very weak, temperature up to 99F. Symptoms lasted about two days. One day after 2nd dose: temperature up to 99F, heart rate increased to 130's resting (lasted about an hour), systolic blood pressure to 140's resting (lasted about an hour), felt flushed in the face, headaches, weak, temperature up to 99F, no dizziness. Symptoms lasted about one day.
43 2021-03-15 discomfort The time prior to the vaccine, I had no pelvic pain or limitations in physical activity. 1/7/2021 ... Read more
The time prior to the vaccine, I had no pelvic pain or limitations in physical activity. 1/7/2021 Received Pfizer Vaccine #1 experienced left arm soreness at the injection site. The evening of 1/7/2021 following the injection, developed dull lower pelvic pain. Pelvic pain worsened over the next two days 1/9/2021 Symptoms of pelvic pain intensified to now excruciating, sharp pain 1/10/2021 Seen at nearby urgent care and evaluated by healthcare provider; referred to nearby emergency department for further evaluation, work up and recommended imaging. Evaluated by emergency room physician, lab work collected and imaging were completed. CT scan showed 7cm mass in the right pelvis, small amount of pelvic fluid. Pelvic ultrasound was also completed and confirmed 7 cm round lesion in the right adnexa. Discharged home with pain medication and instructions for outpatient follow up. 1/12/2021 Seen by PCP and referral sent OB/GYN; Symptoms are now as dull pelvic pain, associated with rectal pressure and a pelvic pulling sensation position dependent, also associated with intense internal rectal pain at the time of bowel movements and weight loss. 1/14/2021 Seen by OB/GYN, repeat pelvic ultrasound ordered 1/22/2021 Repeat pelvic ultrasound completed showed 7.4 cm right adnexal cystic lesion increased in size 1/28/2021 Received Pfizer Vaccine #2, staff at vaccination clinic informed of pelvic pain onset after Vaccine #1 injection. Approximately 4 hours after Vaccine #2, I developed severe sharp pain again similar to after Vaccine #1 which required pain medication for relief. 1/29/2021 Pain improved with medication 1/30/2021 Symptoms have now returned to dull pelvic pain, associated with rectal pressure and a pelvic pulling sensation position dependent, also associated with intense internal rectal pain at the time of bowel movements and continued weight loss until scheduled surgery 2/26/2021. 2/12/2021 Seen by PCP, cleared for surgery; labs completed 2/17/2021 Seen by OB/GYN for preoperative visit 2/23/2021 Seen at hospital for COVID Preop Testing 2/26/2021 Surgery completed under general anesthesia ? Laparoscopic myomectomy with mini-laparotomy, lysis of bowel adhesions to degenerating fibroid tumor The time prior to the vaccine, I had no pelvic pain or limitations in physical activity.
43 2021-03-15 numbness 43 YO F C/O NUMB SENSATION IN HER FACE SOME UNUSUAL SENSATION IN HER TONGUE FOLLOWING COVID SHOT. DE... Read more
43 YO F C/O NUMB SENSATION IN HER FACE SOME UNUSUAL SENSATION IN HER TONGUE FOLLOWING COVID SHOT. DENIES OTHER C/O TO INCLUDE DIFFICULTYBREATHING, SWALLOWING, SPEAKING, DENIES SWELLING IN OR AROUND FACE/MOUTH, NAUSEA, OR OTHER C/O. PT INITIALLY WAS WILLING TO GO TO ER BUT HER SXSUBSIDED WHILE WAITING FOR AMBULANCE AND SHE DECIDED TO AMA AND FOLLOW UP ON HER OWN. FOUND ABOVE PT A/O X4, NO OBV DISTRESS, NO OBVIOUS ANGIOEDEMA, SPEAKS IN FULL SENTENCES, CLEAR LS BILAT ALL, SOME HIVE LIKE RASH ON ANTERIOR CHESTBELOW THE CLAVICLES, EXTREM - PWD, GOOD PMS X4, MOVES ALL WITH PURPOSE
43 2021-03-15 pain in extremity Notes Expand AllCollapse All Patient: ... Read more
Notes Expand AllCollapse All Patient: DOB: 6/11/1977 Date: 3/15/2021 MRN: Subjective Patient is a 43 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and "head rush", feeling dizzy and had a metallic taste in mouth (shortly resolved). Sensation of chest tightness as reported upon her arrival to bay. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Medical hx includes asthma and allergies, pvcs and IgG deficiency ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded) Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain and headaches R arm pain where injection site is. Ice pack given for site.: Previous Reactions: flu vaccine 20 years ago. She's done well with flu vaccines since then. Objective Vitals Vitals: 03/15/21 1244 03/15/21 1254 03/15/21 1310 BP: 128/85 122/65 Pulse: 86 86 86 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear airway Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: Hyperventilating upon arrival to bay. Pt improves with deep breathing. Pt did take her levalbuterol as well during her stay which did help her chest tightness. No wheezing heard pre/post administration. O2 sats 100% Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) R arm pain; injection R arm. Ice pack placed. Anxiety: hyperventilating, relieved with instructed deep breathing and removal of mask for short time. Lightheaded/dizzy: related to anxiety and systemic stress response. She reponded well to zyrtec, water and snack. Pt able to recover and stand w/o symptoms. She was ambulated out to the front w/o difficulty accompanied by this provider. She's to follow up with pcp/allergist. Pt voiced appreciation of care today.
43 2021-03-16 numbness, tingling Began to feel facial tingling and numbness 3 minutes post vaccination; "things started spinning and ... Read more
Began to feel facial tingling and numbness 3 minutes post vaccination; "things started spinning and vision was blurry"; nausea-began having dry heaves (had not eaten), CBG 123, HR bradycardic and erratic, developed pounding HA, EMT stated "throwing PVCs"; then went to ER in POV
43 2021-03-16 muscle twitching, flushing Received first doze today at 3:00 PM, around 4:00 PM my face became flushed/pink. 4:30 I noticed th... Read more
Received first doze today at 3:00 PM, around 4:00 PM my face became flushed/pink. 4:30 I noticed that both sides of my face twitch uncontrollably when I smile.
43 2021-03-16 pain in extremity Pain in left arm Swollen and painful lymph nodes in left armpit, radiating across back under shoulde... Read more
Pain in left arm Swollen and painful lymph nodes in left armpit, radiating across back under shoulder blades Nausea Fatigue All symptoms began roughly 12 hours after administration. Today is the fourth day, and symptoms are persisting.
43 2021-03-17 flushing Patient reported feeling flushed, itching, and redness all over body about 30 minutes after injectio... Read more
Patient reported feeling flushed, itching, and redness all over body about 30 minutes after injection. 50mg of IM Benadryl given in the right deltoid. Patient tolerated well. No signs of respiratory distress. Observed 30 mins after Benadryl given. Patient alert and oriented. Left in accompany of coworker. Instructed to call 911 if signs of respiratory distress.
43 2021-03-17 muscle spasms, feeling hot Client reports that she felt light-headed, nauseous and hot. She also reported that she felt sick ... Read more
Client reports that she felt light-headed, nauseous and hot. She also reported that she felt sick and had cramping to both hands, approximately 1-2 minutes after receiving dose one of the Pfizer vaccine. Her symptoms lasted 5-10 minutes. After approximately 15-20 of observation, client reports she was feeling better, and left the premises on her own.
43 2021-03-17 tremor Low grade fever of 100.2, shakes, Body Ache, Mild headache, and nauseous from about 8 on Tuesday and... Read more
Low grade fever of 100.2, shakes, Body Ache, Mild headache, and nauseous from about 8 on Tuesday and felt better by Thursday morning
43 2021-03-18 numbness, coordination abnormal generalized hypoesthesia, extreme for 36 hours, fading but still present 7 days out fatigue, nausea,... Read more
generalized hypoesthesia, extreme for 36 hours, fading but still present 7 days out fatigue, nausea, lack of coordination
43 2021-03-18 pain in extremity By 4PM that day I had extreme lethargy and pain in my left arm and body. After a few days, I develo... Read more
By 4PM that day I had extreme lethargy and pain in my left arm and body. After a few days, I developed headaches and muscle stiffness and pain on left side of my body. At the ten day mark, I developed severe joint and muscle pain in left arm and shoulder and continued headaches, feeling unwell.
43 2021-03-18 pain in extremity Fatigue; arm pain; general malaise; This is a spontaneous report from a contactable consumer, the pa... Read more
Fatigue; arm pain; general malaise; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 12Feb2021 at 16:45 (at the age of 43-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included fibromyalgia, asthma, high blood pressure and allergy to ACE inhibitors. Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 13Feb2021 at 12:00 AM, the patient experienced fatigue, arm pain and general malaise. No treatment was provided for the events fatigue, arm pain and general malaise. The outcome of the events fatigue, arm pain and general malaise was recovering. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021277048 same patient, different shot/event
43 2021-03-18 tingling tingling in L arm radiating to finger. Became lightheaded and felt BP rise. Symptoms began N 10 min... Read more
tingling in L arm radiating to finger. Became lightheaded and felt BP rise. Symptoms began N 10 minutes after vaccination. ___BP 126/96 P=86 R=18
43 2021-03-19 muscle spasms Fever, aches, muscle spasms, pain, headache, dizziness, fatigue, dry mouth Started about 12 hours af... Read more
Fever, aches, muscle spasms, pain, headache, dizziness, fatigue, dry mouth Started about 12 hours after vaccine received, lasted 24 hours
43 2021-03-19 pain in extremity Sore arm, headaches, tinnitus
43 2021-03-20 depressed level of consciousness, slow speech 1310-Went to the Observation area as a patient was not feeling well, after her 2nd pfizer vaccine, t... Read more
1310-Went to the Observation area as a patient was not feeling well, after her 2nd pfizer vaccine, to the left arm. Medical personnel and I went to the patient and she was sitting in a chair in the 30 min area and she had altered level of conscious. The patient stated she started not feeling well, had some chest pressure and felt she was going to pass out. We stayed with the patient, Vitals signs 149/87 HR 89, pulse ox 98% respiratory 12 Lungs clear in all fields. Patient denied any shortness of breath, and denied any swelling of her throat or tongue. I advised the patient to focus on her breathing and if this had happen before and she stated yes, the patient identified that she is allergic to the influenza shot and yellow fever and this happened when she had those injections, and she was ok after a few minutes. I asked the patient if she had any of these symptoms with the first Pfizer injection and she stated yes, but very little and didn't say anything to anyone during the first injection. We continued to stay with the patient. The patient never losses consciousness, however it appears to be decrease as she was speaking slowly and moving her arms slowly, then the patient start to cry and could answer the questions normally. I asked if the patient was alone or if someone was with her and she stated her husband. I asked the patient to please call her husband and she did. Other medical personnel remained with the patient and I went to the front and found the husband. While I took the husband to the patient she started to have decease level of conscious and we took the patient's vital signs again. 1321- 130/88, HR 77, pulse Ox 96% respiratory rate 14. I continued to talk with the patient and the patient level of conscious returned. The patient stated she had some chest pressure and this was her normal to the reaction, she started to cry again. I continued to comfort the patient and we spoke and the patient identified that she had this reaction with anesthesia before, also dental work, and also with Demerol. I advised the patient to please reach out to her primary physician right away, to discuss the reaction that she is encountering as they maybe able to find out what her body is reacting to and she verbalized understanding. The patient remained in observation and was communication normally. at 1328 vitals signs were completed 133/85, HR 78, pulse ox 96%, respiratory rate 14. Other medical personnel and I continued to monitor the patient and at 1344 vitals signs completed 142/87, HR 70 pulse ox 98% respiratory rate 14. Patient stated she was much better and felt good to go home to eat something and the patient was sent home with her husband.
43 2021-03-20 slurring On the second day after vaccine, about 25 hours later, I threw up, became disoriented, sleepy, and w... Read more
On the second day after vaccine, about 25 hours later, I threw up, became disoriented, sleepy, and was slurring my words. I have little recollection of the 2-3 hour period following throwing up and was in and out of consciousness, almost as if I had a concussion. I continued with my day, not knowing that I was not making sense, and had professional interactions with coworkers and clients, who later reported that I sounded confused, sleepy, and disoriented. I drove my car and received a parking ticket during that time. Since I did not have flu-like symptoms and felt fine for 24 hours directly following the vaccine, I thought I was fine. It actually scares me that I drove my car and that this could happen to others. I was back to normal 4-5 hours after symptoms started, and still had hazy to no recollection of the afternoon. I had to piece together the conversations and interactions the following day. I had a headache the following day and was tired.
43 2021-03-20 tingling L-arm tingling , "heaviness" - site w/o swelling redness - + pulse. 5 mins later - midline chest t... Read more
L-arm tingling , "heaviness" - site w/o swelling redness - + pulse. 5 mins later - midline chest tightness "uncontrollable urge to belch" without other assoc. symptoms; 125/93 -- 95 -- 120/89 chest tightness much improved - conversing & cheerful.
43 2021-03-21 burning sensation VR stat burning from arm through chest, tingling tongue
43 2021-03-21 flushing, weakness Patient had her covid vaccine at 7:22am. Around 7:35 am she said she was flushed, diaphoretic, and w... Read more
Patient had her covid vaccine at 7:22am. Around 7:35 am she said she was flushed, diaphoretic, and weak. I took her bp. It was 136/102. Her HR was 97. RR 16. Pulse ox 99%. Patient reports a hx of anxiety. She also did not eat breakfast. We got her juice, water, and a breakfast bar. At 7:50, she started feeling a lot better. BP was 137/95 with HR of 79. At 8am, her bp was 124/96. Her HR was 91. Her husband took her home.
43 2021-03-21 flushing Headache Diarrhea Flushed/feverish (no fever)
43 2021-03-21 tingling Patient received Pfizer vaccine L Deltoid at 0950. At 1003 She complained of swollen, tingling, and... Read more
Patient received Pfizer vaccine L Deltoid at 0950. At 1003 She complained of swollen, tingling, and red hands b/l. No SOB, throat swelling, itching, scratching, no tongue swelling. AAO x 3. Talking with no difficulty. No known allergies. Benadryl 25 mg PO was administered. She was monitored. No further symptoms.
43 2021-03-21 tremor, feeling cold Pt said she felt dizzy and "off" and that she needed to lie down. Brought into medical bay via wheel... Read more
Pt said she felt dizzy and "off" and that she needed to lie down. Brought into medical bay via wheelchair, (she was already in one) Laid down. Reported felt cold, blankets given, vitals taken and stable. Pt was shakey at times but reported she felt fine. Vitals remained stable. Shakiness subsided within 10 mins. Then pt rested comfortably for about 20 mins. sat up. VS stable. Left in her wheel chair at 11:20, felt much better.
43 2021-03-22 weakness very achy weak cold can not get warm temp is 100.1
43 2021-03-22 numbness Within about 15 minutes I experienced numbness in my shoulder, then clavicle into neck, it felt odd.... Read more
Within about 15 minutes I experienced numbness in my shoulder, then clavicle into neck, it felt odd. About 20 mins after the shot the numbness spread into the left side of my face. It was extremely numb as if I had novacaine. The numbness lasted intensely for about an hour. Then it was periodically for about 36 hours after the shot. I was very tired about 2 hours after giving the shot and that lasted about 24 hours. I could not pick up my left arm for 24 hours at all. It wasn?t until 3 days later that I could pick my arm up.
43 2021-03-22 pain in extremity Left arm pain, swelling and swollen glands day of immunization. Left arm pain and limited mobility ... Read more
Left arm pain, swelling and swollen glands day of immunization. Left arm pain and limited mobility ongoing . (3 months now.)
43 2021-03-22 tingling Tingling in the cheeks on both sides of the face. More minor tingling in lips and tongue. Mostly r... Read more
Tingling in the cheeks on both sides of the face. More minor tingling in lips and tongue. Mostly resolved after 2 hours, though still felt around 6pm
43 2021-03-22 trigeminal neuralgia, migraine, facial pain After receiving the first shot, I had a taste of metal in my mouth. I sat down and in the next 30 m... Read more
After receiving the first shot, I had a taste of metal in my mouth. I sat down and in the next 30 minutes passed out. For the next three weeks, I had migraines more frequently than my usual migraines and a new pain behind my eye. After receiving my second doses, I felt extremely tired and within 3 hours of receiving got shooting pain on left side of my face. I was diagnosed with Trigeminal Neuralgia by Dr on March 22, 2021. This pain has been constant since receiving the second dose on March 8.
43 2021-03-23 bell's palsy, facial paralysis Recurrence of left side facial Bells Palsy. tingling of left lower and upper lip and slight droop of... Read more
Recurrence of left side facial Bells Palsy. tingling of left lower and upper lip and slight droop of left side of mouth.
43 2021-03-23 throat numbness 20 minutes after shot, tingling and numbness/swelling in throat and lips; did not feel any blockage ... Read more
20 minutes after shot, tingling and numbness/swelling in throat and lips; did not feel any blockage in my airways and could breathe easily through my nose, but did feel constricted in my throat for about 40 minutes.
43 2021-03-23 unresponsive to stimuli, weakness Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: PT. FAINTED, BU... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: PT. FAINTED, BUT HER VITALS WERE NORMAL AND LAID HER FLAT ON FLOOR. ACCORDING TO HUSBAND, PT. HAD NEEDLE FEAR AND WHEN SHE GETS ANXIOUS USUALLY FAINTS OR DIZZY. AFTER 3 TO 4 MINUTES , WITH WATER AND GATORADE DRINK, PT. WAS FINE WITH NORMAL VITALS AND LEFT STORE WITH SPOUSE
43 2021-03-24 burning sensation Dormant small fiber neuropathy (Erythromelalalgia) on hands only became full flare 5 days after 1st ... Read more
Dormant small fiber neuropathy (Erythromelalalgia) on hands only became full flare 5 days after 1st dose EN6203 on 03/02/21- never before had symtoms of burning on face, ears, hands, neck, arms, legs. Doctor treated with prednisone and flare subsided after 10 days. After second dose ER8732, extreme flare within 24 hours. Burning on hands, face, ears, arms, legs, feet. Doctor treating with prednisone.
43 2021-03-24 burning sensation Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swel... Read more
Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swelling; Chest pain/burning in her throat and chest; Rapid heart beat; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 16Mar2021 at 02:00 PM at single dose (lot number: EN6208, expiration date: 30Jun2021) for COVID-19 immunization. Medical history included known allergies to 32 meds and nuts and shellfish, asthma, COPD and seizures and chronic lung disease. Concomitant medications included prednisone and topiramate (TOPAMAX) in two weeks. The patient had no other vaccine in four weeks. The patient was not pregnant when vaccination. The patient was given the covid 19 shot and within mins. The patient tested the shot and started to have itching and burning in her throat and chest and arm and given 50 mgs of Benadryl in her inhaler then a hour later had to go to ER due her throat swelling closed and chest pain, rapid heart beat was given Benadryl n Prednisone. Events started from 16Mar2021 02:15 PM. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient was recovered with lasting effects. Treatment was received for AE at ER 50 mgs Benadryl and 60 mgs of Prednisone. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovered with sequel. Seriousness criteria was reported as life-threatening.
43 2021-03-24 flushing Felt Faint, flushed, panicky
43 2021-03-24 numbness, tingling, pain in extremity, hypersensitivity of all senses The day after my second dose I started having lower back pain and pain in my thighs. As days pass t... Read more
The day after my second dose I started having lower back pain and pain in my thighs. As days pass the pain has only intensified. I've had tingling, numbness, extreme sensitivity and a deep dull pain in my thighs. I use lidocaine patches for my back. But the pain in my legs does not go away. It intensifies in the evenings and at night. I have not been able to sleep since the pain started.
43 2021-03-26 weakness, unresponsive to stimuli Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotens... Read more
Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Weakness-Medium, Additional Details: Patient became unresponsive. We gave cold compress to help with this. Blood pressure was 76/46. This happened at 10:57 am. We ask if patient was a diabetic she said no. Follow up phone call was completed around 4:30pm but no response. VM was left for patient to call back with update.
43 2021-03-26 migraine, flushing Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills,... Read more
Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills, Stomach and Chest Pains, Reflux and Heartburn, Flushing, Swelling/Edema, Dizzy, Lethargy, Brain-Fog// I?ve been trying to get diagnosed- have had some of these symptoms since September, but a couple/ few hours after the shot, I have been having all of those symptoms throughout the day and the ones I?ve had have been very-exacerbated; I?ve finally been able to hold down food.
43 2021-03-26 pain in extremity, discomfort By the next day, on the 26th I had mild injection site pain. During the night then between the 26th ... Read more
By the next day, on the 26th I had mild injection site pain. During the night then between the 26th and 27th a lymph node in the r. axilla became enlarged and sore. The entire r. arm is just achey other than the injection site pain and axillary discomfort. I do have a migraine as well, but I believe it is due to my mentrual cycle.
43 2021-03-26 pain in extremity Grade 3, swelling at injection site, arm pain after injection on Friday and today, Saturday after se... Read more
Grade 3, swelling at injection site, arm pain after injection on Friday and today, Saturday after second dose with LVN. The nurse LVN may not have injected it correctly. I struggled to do dishes after dinner. My arm pain kept me awake last night. I didn't have any arm pain or swelling at injection site with the first Pfizer dose with nurse. No Pain or side effects whatsoever with the first Pfizer vaccine. Vaccine may be fine. It might be the way the nurse injected it.
43 2021-03-26 tingling not feeling self, tingling
43 2021-03-27 burning sensation Fever, brisket, burn, skin coloration
43 2021-03-27 feeling hot Fast pulse (160), tickling in throat, feeling of warmth 10 min went away, started back after 5 min. ... Read more
Fast pulse (160), tickling in throat, feeling of warmth 10 min went away, started back after 5 min. Took benadryl went away after 10 min
43 2021-03-27 numbness Started 15 min post vaccine injection. Dizzy, fainting, low blood pressure. Numbness in hands/feet. ... Read more
Started 15 min post vaccine injection. Dizzy, fainting, low blood pressure. Numbness in hands/feet. Took an hour to recover.
43 2021-03-27 numbness complain of chest pressure and numbness of left arm blood pressure 183/116, 90,18, 100 % RA, ECG-NSR... Read more
complain of chest pressure and numbness of left arm blood pressure 183/116, 90,18, 100 % RA, ECG-NSR, 12 lead shows no ST elevation noted Patient did not want to go to hospital. Husband stated he would take her in personal care. Alert and oriented x4 - signed refusal
43 2021-03-27 pain in extremity Swollen lymph node under right arm almost immediately following injection, pain and soreness. Four d... Read more
Swollen lymph node under right arm almost immediately following injection, pain and soreness. Four days post vaccine, lymph node under am is still very swollen, pain and soreness down arm still present.
43 2021-03-27 tingling AT FIRST HAD PAIN/TENDERNESS AT INJECTION SITE LIKE THE FIRST SHOT BUT NOT NEARLY AS BAD, BUT AFTER ... Read more
AT FIRST HAD PAIN/TENDERNESS AT INJECTION SITE LIKE THE FIRST SHOT BUT NOT NEARLY AS BAD, BUT AFTER 24 HOURS, I HAD AN ACHY PAIN RADIATING FROM MY ELBOW TO MY FINGERTIPS AND HAD PINS AND NEEDLES ONE NIGHT. THE PAIN IS SIMILAR TO CARPEL TUNNEL PAIN. IT HAS NOT RESOLVED. I'VE BEEN BRACING IT AND WILL START TAKING OVER THE COUNTER ANTI-INFLAMMATORY PAIN MEDICINE. JUST WANTED TO REPORT IT B/C I HAVEN'T SEEN ANYONE ELSE REPORT THIS KIND OF REACTION. IT IS MY LEFT ARM; MY NON-DOMINANT ARM AND I HAVE NEVER HAD THIS SORT OF PAIN IN MY LEFT ARM.
43 2021-03-28 numbness, tingling About 18 minutes after receiving the vaccine, I started to feel a little numb on the right side of m... Read more
About 18 minutes after receiving the vaccine, I started to feel a little numb on the right side of my collar bone and then a tingling in my right pinky toe and finally under my right eye. We had already left the vaccine site so I told my daughter who was driving that I felt a little funny and would let her know if she needed to take me to the hospital. I had not eaten yet that day, only coffee in the morning so we ran a couple of errands and then grabbed lunch. Around 3:30pm on the same day (3/28/2021) I started to feel better and the only side effect I currently have is tenderness in my arm where I received the shot. I did not seek medical treatment as it went away within a couple of hours.
43 2021-03-28 pain in extremity, migraine, muscle twitching Nausea, chills, light sensitivity, migraine, pain radiating through left arm ( couldn't move arm af... Read more
Nausea, chills, light sensitivity, migraine, pain radiating through left arm ( couldn't move arm after several hours), loss of appetite, emotional mood swings, twitching in left hand and eyes, lethargic,
43 2021-03-29 pain in extremity After injection, felt mild to modeate pain on the arm. By the next day, I started to feel pain in my... Read more
After injection, felt mild to modeate pain on the arm. By the next day, I started to feel pain in my shoulder up to the neck area and stiffness. The pain has caused difficulty with my sleep. Used acetaminophen the next day, then changed to ibuprophen since the third day. Used ice on shoulder/neck and massage area with pain ointments since the third day. The symptoms have not yet resolved.
43 2021-03-29 pain in extremity chest pain, arm pain, dizziness
43 2021-03-29 pain in extremity Headache, achiness, exhaustion, achy arm, feeling unwell.
43 2021-03-29 tenderness low grade fever. Highest temperature was 100 and fell to 99.3 after hours. I had a headache and musc... Read more
low grade fever. Highest temperature was 100 and fell to 99.3 after hours. I had a headache and muscle aches. My skin was sore to touch and body ached to the point t I could barely walk or raise my arms over my head. The symptoms subsided after day 4.
43 2021-03-30 inability to speak Progress Notes Expand AllCollapse All Patient: ... Read more
Progress Notes Expand AllCollapse All Patient: DOB: Date: 3/24/2021 MRN: Subjective Patient is a 43 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience difficulty speaking. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms, respiratory distress and tongue swelling. Past Medical History: Diagnosis Date ? Addison's disease (HCC) ? Asthma ? Depression ? Hypothyroidism ? Pulmonary HTN (HCC) ? Restless legs ? Rheumatoid arthritis(714.0) ? Sjogren's disease (HCC) PT on home O2. Followed by medical center. Pt also reports hx of serotonin syndrome. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches + aphasia: Previous Reactions: none Objective Vitals Vitals: 03/24/21 1510 03/24/21 1513 BP: 105/74 123/69 Pulse: 98 96 SpO2: 97% 95% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. Interventions: Nasal cannula in place. Comments: Personal O2 via NC HENT: Head: Jaw: Trismus present. No tenderness, swelling or pain on movement. Comments: aphasia Mouth/Throat: Mouth: Mucous membranes are moist. No angioedema. Pharynx: Oropharynx is clear. Uvula midline. No pharyngeal swelling, posterior oropharyngeal erythema or uvula swelling. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Comments: +5/5 strength to upper and lower extremities. No facial drooping. No tongue/throat swelling . Pt points to jaw line and TMJ as the muscles are affected. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: no change. Patient discharge: Transported to ED by ambulance. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Pt with no other neuro deficits but aphasia is clearly present. Medical team called to have pt brought to ED for further evaluation. Husband will meet her there.
43 2021-03-30 feeling jittery muscle/joint aches; Shakey/jittery; jittery; rapid heart rate; Fever of 103.8; Chills; muscle/joint ... Read more
muscle/joint aches; Shakey/jittery; jittery; rapid heart rate; Fever of 103.8; Chills; muscle/joint aches; This is a spontaneous report from a contactable female nurse reported for herself (Non pregnant). A 43-year-old female patient(nurse) received second dose of BNT162B2 (Solution for injection, lot number: unknown) via left arm on 28Jan2021, 15:00 PM, single dose for COVID-19 Immunization. Patients receive other vaccines within 4 weeks prior to the COVID vaccine the patient took other historical vaccine included first dose BNT162B2 (lot number: Unknown) on 07Jan2021, at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient received other vaccines within 4 weeks prior to the COVID. Patient had allergies to medications Bactrim.
43 2021-03-30 numbness, facial paralysis, bell's palsy Quickly progressing facial paralysis after extreme ear pain on same side of face. Diagnosed as Bell'... Read more
Quickly progressing facial paralysis after extreme ear pain on same side of face. Diagnosed as Bell's Palsy. Extreme case per doctor. Some loss of taste. Persistent extreme pain in and around ear and traveling down neck; all same side. Eye won't close. Difficulty drinking, and difficulty eating without choking. Numbness on entire right side of face with full paralysis. Treatment is Valacyclovir, Gabapentin, Prednisone, Tramadol. And keeping eye covered at all times.
43 2021-03-30 pain in extremity Pain in left arm; Rash in neck and upper body; heat and itching in area; heat and itching in area; T... Read more
Pain in left arm; Rash in neck and upper body; heat and itching in area; heat and itching in area; This is a spontaneous report received from a contactable consumer reporting for self. A 43-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 07Mar2021 11:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the first dose on 14Feb2021. Medical history included asthma, lactose intolerance. Patient had allergies to Bactrim, Sudafed. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), diphenhydramine hydrochloride (BENADRYL), ibuprofen, colecalciferol (VITAMIN D [COLECALCIFEROL]), vitamins. The patient experienced Pain in left arm, Rash in neck and upper body, heat and itching in area on 08Mar2021 16:00. Outcome of events was not recovered. Information on the lot/batch number has been requested.
43 2021-03-30 pain in extremity Arm was sore at then 12 hours after vaccination chills, fever of 102.5, headache and achy began. Thi... Read more
Arm was sore at then 12 hours after vaccination chills, fever of 102.5, headache and achy began. This lasted for 8 hours.
43 2021-03-30 seizure Patient reportedly had seizure after placement of the Pfizer/BioNTech COVID-19 vaccine. The patient ... Read more
Patient reportedly had seizure after placement of the Pfizer/BioNTech COVID-19 vaccine. The patient received the vaccine at a COVID vaccination clinic. The patient had vaccination needle in her arm, and then almost immediately after, within 3 minutes, that she had a seizure event. It was for extremity shaking lasting a couple minutes which then resolved. This was witnessed by family and they kept her from having any injury sustained. Reportedly she also was very scared receiving the vaccine and "when she gets scared she has her seizures". Mother reports that the patient seizes about once a month and has had other seizures with interventions like brushing teeth. The patient has been taking her medications for seizures. Patient was postictal when medics arrived. Glucose was 79. No recent illness. No recent injury or fever. Had coronavirus over the summer.
43 2021-03-31 weakness 26 hours after the 2nd injection - body aching, chills, fatigue, weakness and mild headache . By th... Read more
26 hours after the 2nd injection - body aching, chills, fatigue, weakness and mild headache . By the morning these symptoms resolved
43 2021-03-31 feeling cold Develops cold feeling throughout body ad tingling sensation in throat. Denies SOB or trouble swallow... Read more
Develops cold feeling throughout body ad tingling sensation in throat. Denies SOB or trouble swallowing. Given benadryl 25mg PO x 1. Discharged home with family under stable condition. SPO2 97% RA HR 95 RR 14 even and unlabored
43 2021-03-31 feeling cold Starting a few hours after the shot, I felt tired, then started to feel achy. Lost appetite, felt co... Read more
Starting a few hours after the shot, I felt tired, then started to feel achy. Lost appetite, felt cold (no fever). Flu like symptoms through the night. Took Advil, which helped. The next afternoon I vomited and had a fever for a few hours. Was mostly 100.5, highest was about 101. Fever subsided around 10pm. Still feeling tired and slightly achy today, but no fever or nausea.
43 2021-03-31 tremor Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: metalic taste in mouth, heart racing
43 2021-04-01 burning sensation, tingling No side effects after vaccine. I had my hair done on 4/1/21 (it was bleached which I have had many ... Read more
No side effects after vaccine. I had my hair done on 4/1/21 (it was bleached which I have had many times before in my life). It tingled and burned like crazy nearly as soon as it was applied. The tingling and burning started to spread throughout my body like my nerves were all reacting. I begged the stylist to get the bleach off so she rinsed it immediately. I've NEVER had that reaction before. One of the stylists said a couple of other patients reported similar reactions and noted it was after that had received their Covid vaccinations. I thought it was important for me to report it just in case there is any link.
43 2021-04-01 burning sensation Shingles; Shingles/she was 7 years old she had her first shingles outbreak; burning sensation; They ... Read more
Shingles; Shingles/she was 7 years old she had her first shingles outbreak; burning sensation; They were flu-like symptoms; Diarrhea; Nausea; achiness; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, Expiry Date: unknown), intramuscular, administered in the right deltoid (also reported as right arm) on 03Mar2021 16:00 at a single dose for covid-19 immunisation. Medical history included patient had anxiety all her life (ongoing), but reported 'started the medication about 10 years ago for the first time'; and patient had hypothyroidism, which she found out when she was going through the in-vitro fertilization. It was further reported that she was diagnosed with hypothyroidism when she and her husband were going through In-vitro fertilization and were having trouble conceiving and her TSH levels were off (date unknown). She didn't feel any different and didn't feel any different now since being on Synthroid; that was the only reason she found out. She was fairly healthy. Patient mentioned that when she was 7 years old she had her first shingles outbreak. Concomitant medications included oral levothyroxine sodium (SYNTHROID) taken for hypothyroidism at 75 ug, daily from an unspecified start date (approximately started 3 years ago) and ongoing; and oral sertraline hydrochloride (ZOLOFT) taken for anxiety at 50 mg, once a day from an unspecified start date (started about 10 years ago) and ongoing. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient had no prior vaccinations (within 4 weeks). Patient stated she do not want COVID and she is a pro-vaccines. Patient received first vaccine shot on 03Mar2021 and was diagnosed with shingles on the morning of 19Mar2021 and wanted to know if it was okay to take second dose of the vaccine next Thursday with active shingles diagnosis and being on antiviral medication, or should she wait. Patient stated that shingles, she was sure it was shingles, will not prevent her from getting second dose. She mentioned she was stuck, this was all new, and her doctor couldn't tell her because he didn't know. She was not sure what to do. She was not sure if she should delay getting the vaccine until she has stopped the antiviral medication, which she later clarified as Famciclovir. She stated initially her symptoms started Monday (Mar2021). They were flu-like symptoms on 17Mar2021. She was having diarrhea and feeling nauseated on 16Mar2021, thought coming down with the flu. On Wednesday (Mar2021), she felt pain, the shingles was on her buttocks. She went to the bathroom and saw red. Yesterday, 17Mar2021, she got a closer look because a burning sensation. When she looked closer, she realized it was shingles. It started more of a flu-ish feeling on Monday and noticed rash erupt on Wednesday. She also started to experience achiness on Monday (Mar2021). She was seen at her physician's office today, 19Mar2021 and was diagnosed with shingles this morning. The events shingles, nausea, diarrhea, flu-like symptoms and achiness were reported as not serious. The event burning sensation was reported as medically significant. Therapeutic measures were taken as a result of the events which included famciclovir, oral from 19Mar2021 and ongoing, at 500 mg, three times a day for shingles. The patient had not recovered from the events burning sensation (reported as worsened), shingles (reported as worsened), nausea, flu-like symptoms, and achiness. The event diarrhea was recovering. The events diarrhea, nausea, achiness, and burning sensation were reported as unrelated to the vaccine suspect product.; Sender's Comments: The events burning sensation, diarrhea, nausea and pain are considered not related to BNT162B2, but intercurrent medical conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-04-01 numbness 30 minutes after injection I felt tenderness in lymph nodes below my ears and then my face became to... Read more
30 minutes after injection I felt tenderness in lymph nodes below my ears and then my face became totally numb. I mostly felt the numbness in the sides of my face and chin. This lasted for approx 1 hour and did not return. I didn?t notice swelling.
43 2021-04-01 muscle spasms, pain in extremity, tenderness My right arm was sore and I had difficulty lifting it consistently until 48 hrs later. 12 hours late... Read more
My right arm was sore and I had difficulty lifting it consistently until 48 hrs later. 12 hours later I had soreness in my right leg and my shoulder and upper back on the right, as well as a side stitch in my right side. I had slight redness at injection site until 48 hrs later.. At 24 hours later, I noticed some 2-3 painful lumps on the back of my head at the base of my skull in my hair, they felt like they were bruises but they had no redness or marks, warmth to touch, or itchiness/irritation. They were mostly sensitive to touch but ached slightly on the Monday (29th) following the injection. On Tuesday and most of Wednesday the lumps were still apparent but were not tender to the touch. On Wednesday night the lumps started throbbing and became much more sensitive to touch again. I couldn't lay on my back to sleep and even bending my neck a bit to sleep on my side made them throb intensely. I was unable to sleep much at all. I took ibuprofen to help the pain and it didn't help. Upon waking Thursday they were throbbing quite intensely and I was beginning to have muscular spasms in my scalp on the back of my head - which is also for me an anxiety reaction, which I was also feeling. I didn't have a headache per se, but the back of my head hurt. If I applied any pressure to the back of my neck on the right I had intense shooting pains from the neck up to the lumps on my skull. I do have pinched nerves in my neck but I have never experienced any pain like that before in that part of my neck nor into my skull. It was very sharp. On Friday morning the neck shooting pains subsided but the lumps remain painful to touch.
43 2021-04-01 pain in extremity Sore arm, neck pain, lower back pain, and chills on first night and next morning. Took three 200mg A... Read more
Sore arm, neck pain, lower back pain, and chills on first night and next morning. Took three 200mg Advil that night and next day. Swollen lymph node in left armpit for three days, starting the 2nd night. Hives starting second night and lasting through third day. They were located under both armpits, breasts, sides of neck, sides of face & forehead, and all along back.
43 2021-04-01 pain in extremity sore arm
43 2021-04-01 throat numbness APPROXIMATLEY 10 MINS AFTER GETTING THE VACCINE, PT COMPLAINED THAT HER THROAT WAS NUMB AND FELT DIF... Read more
APPROXIMATLEY 10 MINS AFTER GETTING THE VACCINE, PT COMPLAINED THAT HER THROAT WAS NUMB AND FELT DIFFERENT. WE GAVIE HER 50MG OF DIPHENHYDRAMINE AND HAD HER SIT FOR ANOTHER 20MINS. WE FREQUENTLY CHECKED ON HER AND SHE SAID HER SYMPTOMS WERE A LITTLE BIT BETTER, NOT GETTING WORST. CONSULTED PT TO TAKE BENADRYL OTC Q 6 HOURS FOR THE REST OF THE DAY AND TO FOLLOW UP WITH PCP. SHE WAS ADVISE TO CALL 911 OR SEE EMERGENCY HELP IF SYMPTOMS WORSEN. WE TRIED TO CALL SEVERAL HRS TO CHECK ON HER BUT SHE DID NOT PICK UP. THE NEXT DAY WE CALLED AGAIN AND PT STATED HER THROAT/SYMPTOMS WERE BETTER AND THAT SHE HAD FOLLOWED UP WITH PER PCP.
43 2021-04-01 tremor At site after got vaccine began shakes n feeling unwell was taken to tent dr said blood pressure and... Read more
At site after got vaccine began shakes n feeling unwell was taken to tent dr said blood pressure and pulse high stayed for 30 minutes and felt better. Over weekend experience dizziness and pain in ear unwell feeling fast heart rate spike to pcp Monday on Tuesday had called dispatch health heart rate high n fast they called ambulance cuz I was tachycardia and high blood and having tremors. Was released under this was anxiety related pcp n cardio dr increased my metoprolol but currently still suffering wit tremors or tics of body . I have no control over movement and not sure when or if this will end. This was only my first dose and not comfortable with getting second and not sure what to do to manage these symptoms.
43 2021-04-02 pain in extremity Very bad pain in in the arm in which I received the 2nd dose of the Pfizer Covid Vaccine. It feels l... Read more
Very bad pain in in the arm in which I received the 2nd dose of the Pfizer Covid Vaccine. It feels like the bone in my arm hurts terrible. I did have pain after the 1st shot but it wasn't 6 days later. This pain has me worried.
43 2021-04-03 migraine Pfizer dose 1 - left arm hurt for 3 days - used ice pack and Advil to ease Pfizer dose 2 - started b... Read more
Pfizer dose 1 - left arm hurt for 3 days - used ice pack and Advil to ease Pfizer dose 2 - started bleeding upon receiving the vaccine. Left arm again hurt the evening of the shot. Next morning I was in a lot of pain and my arm had a red ring and lump. Very tender. I also had a mild headache which turned into a migraine in the evening. Third day after vaccine my arm still hurts and the red ring has grown in size and mildly itches. (As I type I am in day 3).
43 2021-04-03 muscle spasms Muscle spasm in right thigh and left side of neck
43 2021-04-03 nerve pain, muscle twitching, muscle spasms Lip began tingling at 1PM. By 8PM that night, it was extremely enlarged. Face was swollen next day. ... Read more
Lip began tingling at 1PM. By 8PM that night, it was extremely enlarged. Face was swollen next day. Eyes and throat began swelling. Doctor told me to use the epipen on myself since I was salivating a lot. Called the ambulance and was taken to Hospital. Doctor told me that they thought the Lisinopril allergic reaction was activated. It is now Sunday (four days later) and I am experiencing muscle aches in my right arm and nerve pain in my right hand/fingertips. On Saturday, my right arm was twitching and cramping. Felt chills on Friday.
43 2021-04-03 pain in extremity Extreme pain in upper arm, hurt to move, low grade fever - for approximately 7 days
43 2021-04-03 pain in extremity Sore arm - began about 4 hours after shot, lasted about 24 hours. Fever, chills, body aches - began ... Read more
Sore arm - began about 4 hours after shot, lasted about 24 hours. Fever, chills, body aches - began 12 hours after shot, lasted about 36 hours. Fatigue - began 12 hours after shot, lasted about 48 hours.
43 2021-04-03 tenderness Lump in my neck, near my collarbone, on the side where the vaccine was administered. Visible and pai... Read more
Lump in my neck, near my collarbone, on the side where the vaccine was administered. Visible and painful to the touch.
43 2021-04-03 tremor High Fever and chills for two days, shaking, aches and pains all over, chest pain, soar throat, head... Read more
High Fever and chills for two days, shaking, aches and pains all over, chest pain, soar throat, headache.
43 2021-04-04 breast pain 1)Experienced sporadic pulling/tugging pain in left breast. 2) Menstrual cycle was late by 16 days a... Read more
1)Experienced sporadic pulling/tugging pain in left breast. 2) Menstrual cycle was late by 16 days and is usually extremely regular.
43 2021-04-04 burning sensation Severe shoulder pain. I had a burning sensation in my shoulder immediately following the vaccination... Read more
Severe shoulder pain. I had a burning sensation in my shoulder immediately following the vaccination which lasted about an hour; I received my vaccine Friday afternoon. I woke up Sunday morning with a terrible pain in my shoulder, the same place that had previously experienced the burning sensation. It is painful to raise my arm or rotate my shoulder. Even deep breathing/yawning causes pain in my shoulder. I have tried taking over the counter ibuprofen and Aleve and it has not helped. I have also had a headache since Saturday.
43 2021-04-04 feeling hot My right upper arm, about four inches in diameter around the injection site, became swollen, hot, te... Read more
My right upper arm, about four inches in diameter around the injection site, became swollen, hot, tender and incredibly itchy. I attempted to control with oral benadryl for 24 hours, the redness grew and the itchiness remained intense. Topical benadryl with cold packs seemed to help temporarily. This lasted approximately 4 days. At that time the redness and swelling faded, giving way to bruising, and the itching has become less intense but still requires some topical benadryl at least twice per day. No blisters or open sores.
43 2021-04-04 flushing, feeling jittery Patient presented for COVID vaccine and indicated that she has had anaphylaxis but only to allergy s... Read more
Patient presented for COVID vaccine and indicated that she has had anaphylaxis but only to allergy shots in the past, not to other vaccines. Our immunizing technician gave the patient her first COVID vaccine between 2:45 and 3pm. She sat down for observation with her daughter beside her. About 10 to 15 minutes later the patient began coughing more and more profusely. She expressed chest tightness and became flush in her face and upper chest. She stated she was going to use her EpiPen that she carried with her. An in-date EpiPen from the pharmacy was provided instead and the patient self-injected in the right thigh as she was familiar with its use. She was monitored after and she continued to cough along with having some jittery feelings from the EpiPen. This continued for about 3 minutes with her still straining to cough. She wanted to hold off on the second dose of the EpiPen as she was still jittery but the paramedics were called for her. The paramedics arrived and they took over the scene and took her to the emergency room at 3:25pm.
43 2021-04-04 numbness I received my second Pfizer vaccine at about 8:05 Friday morning. The first 12 hours post second sh... Read more
I received my second Pfizer vaccine at about 8:05 Friday morning. The first 12 hours post second shot were uneventful. Then, much like my first shot, the pain in my shoulder started to drastically intensify. Around hour 13, I started to get chills. Intense chills that lasted throughout that night. I had a temperature between 100 and 101. Chills, sweating, and slept fitfully, up and down all throughout the night. Then I woke up the (Saturday) morning after my second dose, and I began to have very intense stomach cramping that was very debilitating. It felt like an awful kind of heartburn. The chills are gone. I still had pain in my shoulder. I was curled up in a ball, then stretching out my body, just trying really to not be in intense, intense pain. Finally, beginning around 1:30 PM on Saturday the pain started to very slowly lessen. By about 5 PM I could say the stomach cramping/heartburn kind of pain was almost fully gone. I woke up on Easter Sunday feeling still like my shoulder hurt, but all the other very very intense pain and symptoms seem to be almost entirely gone ? Well, except the headache that I really hadn?t cared much about while my stomach was cramping. But the headache had been present all day Saturday as well. Saturday and all day Sunday, I had but one of my girlfriends describes as a ?hangover headache.? I would say it?s something like when you have a couple glasses of wine where the tannins don?t agree with you. That lasted all this two days. Sunday evening my shoulder pain started to increase and really really started affecting the muscle connecting my neck to my shoulder, I think it?s called the trapezius. As it intensified, I started feeling numbness in my fingers as we were trying to rub it away. I?ve had really bad knots in that muscle in the past, so the numbness didn?t scare me. The muscles in my left arm continued to cramp and just really hurt. All the way from my trapezius and the side of my neck on that side down through my bicep. And when I say cramping muscles and feeling like they?re knotted, the only way I can think to describe it is to say that they were SCREAMING. I tried everything I could think of, but nothing helped. Finally I used an ice pack which worked for about 20 to 30 minutes and then I used a heating pad which also worked but not for very long. At this point I was just hoping I could sleep. Around 12:30 AM, I was finally able to somewhat drift to sleep after getting in a manageable position, I guess. I woke up every hour or two in screaming muscle pain. And I woke up for good just before 6 AM today, Monday. I've been at work today with strong, but not debilitating, pain in the muscles in my left arm and returned, more mild, heartburn pain in my stomach.
43 2021-04-04 pain in extremity Thursday afternoon, was the first symptom - this was extremely sore arm. Right up in shoulder area- ... Read more
Thursday afternoon, was the first symptom - this was extremely sore arm. Right up in shoulder area- I had a nodule. It hurt really bad. I woke up Friday and it was bigger. I went to Hospital ER - they did an Ultrasound. They believed it was from vaccine. After a week, it went down. Not a steady thing but on a week after the vaccine- but on and off- I never had it before. I have dizzy spells here and there. They go away and then a week later I will get a dizzy spell. It comes out of nowhere, lasts for a few minutes and then it's gone. And the last had a dizzy spell four or five days ago. I haven't gone to the doctor yet.
43 2021-04-04 pain in extremity Every single side effect on the sheet - began with muscle soreness about 2 hours after the shot, whi... Read more
Every single side effect on the sheet - began with muscle soreness about 2 hours after the shot, which lasted about 1 week. Around 2:30am the morning after the shot, I was awakened from a deep sleep by chills and sweats, which lasted for about 36 hours from that moment. These were moderate to severe, such that these symptoms alone would have prevented me from making it through the workday. However, things got worse. Due to chills and sweats, I took my temperate, which was about 99F at that time. Over the course of the next 10 hours the temperature spiked to 100.4F oral. I tried to go back to sleep at 2:30am, but I could only toss and turn due to the chills. Perhaps due to lack of sleep, perhaps due to vaccine, I developed a head ache and some nausea - both of these are extremely rare symptoms for me, as I rarely have a headache more than once a year. By 5am, with climbing temp, sore arm, headache, upset stomach, chills, sweats, muscle aches and exhaustion, I consulted my boss - a 20 yr clinical pharmacist - who advised me this would end after 24 hours. Therefore, I took no meds and waited it out. Soon after 12:30pm, when the fever reached 100.4F, I felt the temperature break. It was almost 24hrs to the moment, and after that the symptoms began rapidly resolving. The temperature subsided completely by about 7pm that evening. Chills and sweats the next morning. Some fleeting headache and nausea the following day. A lot of dizziness and faintness over the next week or so, which I am unsure about - but it could be some sort of backup/accumulation of high dose Mg for my back, in the presence of the vaccine and/or immune response. I say below that I visited the doctor because, if my boss were not a clinical pharmacist, I would absolutely have made a doctor's appointment. Because I get COVID19 tested at work, I had no need to make an MD appt. I got COVID tested, and I consulted with a clinical COVID19 expert - better than a doctor's visit given how long it takes to get in to see my PCP and how little he knows about COVID19 vaccine responses.
43 2021-04-04 tingling Immediately following vaccination my left foot started tingling. I didn't think anything of it at th... Read more
Immediately following vaccination my left foot started tingling. I didn't think anything of it at the time, but it keeps happening from time to time ever since i got the vaccine. I also experienced extreme fatigue and nausea for 48 hours following vaccination.
43 2021-04-04 tenderness After receiving the injection on Wednesday, the initial soreness at the injection site resolved by T... Read more
After receiving the injection on Wednesday, the initial soreness at the injection site resolved by Thursday afternoon. On Friday I began to experience pain, swelling, redness, and a slightly itchy rash at the upper right arm area towards the front and into the under arm area. On Saturday I took OTC Ibuprofen with little effect. Saturday evening I took Benadryl with minor effect by Sunday morning. I took a second dose of Benadryl Sunday. Today, Monday, I still have slight swelling to the upper right arm area, less redness, but tenderness to the touch.
43 2021-04-05 bell's palsy Diagnosed with Bell's Palsy on left side one week after receiving the Pfizer vaccine
43 2021-04-05 feeling hot About 5 hours after receiving the covid vaccine I started to feel flustered. My chin felt hot and a... Read more
About 5 hours after receiving the covid vaccine I started to feel flustered. My chin felt hot and a little itchy. When I looked in the mirror my chest from shoulder to shoulder was red and it looked almost like a prickly heat rash and was slightly itchy. About an hour later it wasn't as red on my chest. My chin still is red and feels irritated (like sunburn). I don't know how else to describe it. I tried calling Pfizer and no one answered. I called CDC but the agent was of no help and didn't have any info that I didn't already have.
43 2021-04-05 pain in extremity 4 hours after shot- sore arm, fatigue, stomach upset 12 hours after- above symptoms plus, body aches... Read more
4 hours after shot- sore arm, fatigue, stomach upset 12 hours after- above symptoms plus, body aches, rash around injection site and chills, headache 52 hours after- itchy/burning rash on arm, left side of face and ear, stomach and back, and still had all of above symptoms Benadryl taken for rash and it disappeared-reappearing 5 hours later and disappeared again after more Benadryl. I kept taking Benadryl for 24 hours. Rash did not reappear. Still experiencing fatigue. Fatigue, headaches and stomachache lasted off and on for 7 days.
43 2021-04-05 tingling Tingling/itchy skin
43 2021-04-06 burning sensation, numbness, pain in extremity, tingling At time of shot, felt stinging pain in the elbow and wrist of left arm, later 5 mins. At some point... Read more
At time of shot, felt stinging pain in the elbow and wrist of left arm, later 5 mins. At some point the next day, I developed Spinal pain. Pain in SI joins, several distinct spots along the spine and the base of my skull, spinal stiffness, difficulty touching knees or putting chin to chest. Lasted 2 days. Night of 3/292021, I woke up with tooth pain in multiple teeth on both upper and lower and right and left sids of mouth. Pain great enough to wake me up and caused difficulty returning to sleep, after 600 mg ibuprofen, able to get to sleep and completely gone in the am. Starting 3/30, pain along nerve paths in upper right side back around scapula, felt like burning, intermittent. Now resolved to tingling / numb feeling and some tingling / decreased sensation in upper lip left side and under eye left side
43 2021-04-06 numbness pt complaining of numbness; arm same as injection 3 numb lasting 20 minutes two fingers back to norm... Read more
pt complaining of numbness; arm same as injection 3 numb lasting 20 minutes two fingers back to normal; pinky still feeling funny and itchy; pt becoming anxious now; c/o of feeling very tired; seen by MD to be transferred to ER accompanied by nurse and physician
43 2021-04-06 muscle spasms On 4/4 at 2am, awoke to chest, arm, neck discomfort, naseau, dizziness, sweating, and chills. Resolv... Read more
On 4/4 at 2am, awoke to chest, arm, neck discomfort, naseau, dizziness, sweating, and chills. Resolved with Tylenol. Fatigue lasted through the day, and by evening body aches returned. On 4/5, peach pit-sized lymph node appeared above collar bone, pain in armpit and neck on right side, fatigue, and aches, along with continues and visible spasms in the neck. 4/7, symptoms still persist, with more swelling spreading across collar bone and into neck.
43 2021-04-06 tingling, bell's palsy Left eye began feeling odd the next morning, face pins and needles, eye feeling weird
43 2021-04-06 tenderness I experienced extremely red cheeks, almost like a sun burn. It hurt to the touch. It started the eve... Read more
I experienced extremely red cheeks, almost like a sun burn. It hurt to the touch. It started the evening of 4/3/21, but on the morning of 4/4/21 it was worse. By the morning of 4/5/21 it had disappeared.
43 2021-04-07 pain in extremity, feeling hot could not walk on her left foot; hot, painful patch on the inner left lower leg below the calf muscl... Read more
could not walk on her left foot; hot, painful patch on the inner left lower leg below the calf muscle; Left lower leg and foot bluer than right; vascular issue; pain and redness was present in the lower left calf/ a large red, hot, painful patch on the inner left lower leg below the calf muscle; pain and redness was present in the lower left calf/a large red, hot, painful patch on the inner left lower leg below the calf muscle/tenderness, pain on affected area; tightness, tenderness, pain on affected area; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6204), via an unspecified route of administration at the age of 43 years old, administered in arm right on 17Mar2021 19:45 at single dose for covid-19 immunisation. Medical history included diabetes, Hashimoto's, PCOS (Polycystic ovarian syndrome), allergies to medications, food, or other products: contrast dye. The patient's concomitant medications were not reported, the patient had received medications within 2 weeks of vaccination, but the patient did not provide the specified drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Thursday morning, 18Mar2021 07:00, after vaccine, pain and redness was present in the lower left calf. This progressed to a large red, hot, painful patch on the inner left lower leg below the calf muscle. This has progressed over the past eight days and the patient had gone to Urgent Care (Sat 20Mar2021) where they were concerned about a clot and sent the patient to the ER. An ultrasound in Mar2021 confirmed there was no clot, but the Dr. did not know what the issue was. The doctor started the patient on an antibiotic. This still progressed and 25Mar2021 it spread bilaterally and could not walk on her left foot. Dr. believed it to be a vascular issue with how it presented at her office 26Mar2021 and was closely monitoring the situation. Left lower leg and foot bluer than right, redness, tightness, tenderness, pain on affected area. Subsides at various points during the day, but always returns at night. The patient was told to keep elevated, try Benadryl, and Advil and keep doctor informed to determine referral vasc Dr. The outcome of the events was not recovered. Date of start of events was reported 18Mar2021 07:00. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Case was reported as non-serious by reporter: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
43 2021-04-07 pain in extremity Arm started aching immediately after being vaccinated. About an hour and a half after getting the va... Read more
Arm started aching immediately after being vaccinated. About an hour and a half after getting the vaccine my nose started running and I threw up three times.
43 2021-04-07 tingling, bell's palsy, nerve injury, facial pain, pain in extremity, discomfort, facial paralysis very sore, stiff arm. At approximately 6 pm the next day, I felt the left side of my face start to ... Read more
very sore, stiff arm. At approximately 6 pm the next day, I felt the left side of my face start to tingle (as if it was numb). General overall feeling of heaviness on left side of face. Noticed in mirror that left side of face was drooping. ER visit, Urgent care visit, and primary care follow up resulted in diagnosis of Bell's Palsy. 10 day course of steroids. Extreme pain continues on left side of face. ENT visit - diagnosis of significant nerve damage related to Bell's Palsy.
43 2021-04-07 tremor, cold sweat Noted onset of headache before leaving the vaccination observation area. Headache located at back of... Read more
Noted onset of headache before leaving the vaccination observation area. Headache located at back of head, with no accompanying symptoms, and later responded to Acetaminophen. Later, on the evening of vaccine receipt, patient felt sweaty and clammy and experienced chills and shaking; did not have a thermometer to check temperature; these symptoms did not interfere with sleep and were gone upon awakening on 6 Apr. Also, on night of vaccine receipt, patient felt fatigued and a little lightheaded, especially with movement; no worsening of symptoms on 6 Apr, but symptoms had not resolved. Also, reports experiencing diarrhea which started afternoon of 5 Apr (> 4 hours post vaccination); of note, patient reports that she experiences diarrhea each year after receipt of IIV; usually takes 1 or 2 doses of Imodium and typically does not last more than 24 to 48 hours. Denied symptoms c/w immediate allergic reaction within 4 hours of vaccine receipt-no hives/itching/angioedema, no dizziness/disorientation/LOC, no shortness of breath/wheezing/bronchospasm, no increased heart rate/BP, no N/V/adb cramps. No significant local reaction around vaccination site on left upper arm; no swollen or tender axillary lymph nodes . On 8 Apr, patient report "things back to normal"
43 2021-04-08 bell's palsy, facial paralysis Covid vaccines pfizer 1st Dec 20,2020 , 2nd Jan 7th, 2021. April 5th, 2021 Went to ER after numerou... Read more
Covid vaccines pfizer 1st Dec 20,2020 , 2nd Jan 7th, 2021. April 5th, 2021 Went to ER after numerous tests for stroke. DX: Bells Palsy Facial Paralysis TX: very expensive CT scan, Blood Work, EKG, medications, loss of work, acupuncture. Still have it.
43 2021-04-08 feeling hot Pt stated "Funny Feeling in her tongue" Pt states feeling warm and nauseated. Pt states she has a ... Read more
Pt stated "Funny Feeling in her tongue" Pt states feeling warm and nauseated. Pt states she has a "metallic taste in her mouth" BP 132/76 Pulse ox 97% resp rate 20 HR 106
43 2021-04-08 migraine Headaches; migraines; Light and noise sensitivity.; noise sensitivity; This is a spontaneous report ... Read more
Headaches; migraines; Light and noise sensitivity.; noise sensitivity; This is a spontaneous report from a contactable consumer or other non hcp. A 43-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 05:15 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. Medical history included hashimotos thyroid, drug hypersensitivity, food allergy unknown if ongoing, drug hypersensitivity from unknown if ongoing, allergies to medications, food, or other products Cipro, doxycycline. Concomitant medication(s) included sertraline hcl (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; alprazolam (ALPRAZOLAM) taken for an unspecified indication, start and stop date were not reported. On 09Feb2021 the patient experienced headaches, migraines, light and noise sensitivity, noise sensitivity. The outcome of the events was not recovered.
43 2021-04-08 pain in extremity 7 hrs after injection, right Arm with injection swelled up from elbow to shoulder, and moderate pain... Read more
7 hrs after injection, right Arm with injection swelled up from elbow to shoulder, and moderate pain in arm and neck muscle aches. 24 hrs after injection, swelling also occurred in opposite (left) arm, but subsided in injection (right) arm. After 48 hrs of vaccination, swelling is almost gone, but still mild aches in neck and left arm.
43 2021-04-08 tingling, numbness, nerve pain Insomnia for first two days. However, the dizziness began the day after and has not stopped (Curren... Read more
Insomnia for first two days. However, the dizziness began the day after and has not stopped (Currently on Day 12). Have had ulnar nerve pain in side of injection, resulting in numbness and tingling in hand. Visited a doctor who performed basic check ups, and just told me to wait it out. Have also had weakness in muscles and lowered stamina for simple things like walking. Used to walk 2+ miles per day, can barely manage 15 minutes now.
43 2021-04-09 feeling cold, tingling eye had a hemorrhage - it got worse the next day; I feel light headed; head/face is tingly/cold; hea... Read more
eye had a hemorrhage - it got worse the next day; I feel light headed; head/face is tingly/cold; head/face is tingly/cold; eye had a hemorrhage - it got worse the next day; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnant patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 08:30 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included gastric bypass from Jul2018, high blood pressure prior to gastric bypass but has had regular BP (blood pressure) since then, and allergy to penicillin. The patient's concomitant medications were not reported. The patient previously received the first dose of the same vaccine in left arm on 03Mar2021 at 08:30 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 05:00 PM, a day after she received the Pfizer vaccine (2nd dose), her eye had a hemorrhage - it got worse the next day (26Mar2021). She felt light headed and head/face was tingly/cold. Took her blood pressure and it's in a normal range (109/77 111/77). She spoke with a relative that was a nurse practitioner and was advised hemorrhage could be related to vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. Information about batch/Lot number has been requested.
43 2021-04-09 hypersensitivity of all senses Cutaneous Hyperaesthesia Response Feels like an extremely bad sunburn that is sensitive to the slig... Read more
Cutaneous Hyperaesthesia Response Feels like an extremely bad sunburn that is sensitive to the slightest brush of fabric - temperature sensitive as well. My skin feels warm to the touch, but no visible rash or redness or swelling. Pain is intensifying and affected area gradually increasing over the last 8 days - goose bumps are incredibly painful. Started on the outside edge of thighs and hips, moved up my trunk, mostly on the edges about a hands width wide then merged, migrating up my lower back toward to my shoulder blades and down the arms. It?s fully wrapped around my chest and abdomen. Currently, my legs are fine from mid-thigh down to toes and my neck and head also remain unaffected.
43 2021-04-09 numbness, burning sensation, tingling, pain in extremity lower back pain; pain in my thighs/deep dull pain in my legs; I had tingling, numbness and extreme s... Read more
lower back pain; pain in my thighs/deep dull pain in my legs; I had tingling, numbness and extreme sensitivity in my thighs; I had tingling, numbness and extreme sensitivity in my thighs; muscle pain; my thighs feel like they are burning; I do not sleep at nights; This is a spontaneous report from a contactable Physician. A 44-years-old (non-pregnant) female patient received second dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EN6205), via intramuscular on 10Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history included Juvenile rheumatoid arthritis, bilateral hip replacement (both hips) and psoriasis. Allergies were none. Concomitant medications included naproxen sodium, zinc, calcium carbonate, colecalciferol, ascorbic acid. The patient received first dose bnt162b2 (COMIRNATY Batch/Lot Number: EC3247), intramuscular on 09Feb201 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COIVD-19 prior or since the vaccination. On 11Mar2021, after vaccination the patient experienced lower back pain, "deep dull pain in my legs", "her thighs felt like they are burning", muscle pain and tingling, numbness, extreme sensitivity and pain in thighs. Clinical course of the evet was as follows: After the second dose, patient started having lower back pain and pain in thighs. As days passed intensity was increased, tingling, numbness and extreme sensitivity in thighs. She had used ice and heat to help muscle pain, but nothing worked. She also had deep dull pain in legs and sometimes her thighs felt like they are burning. Till two weeks since the second dose her pain had not gone away. Patient could not sleep due to pain. On an unspecified date patient had seen physician who has prescribed medicine included toradol shot but that does not help. She had gone to the ER and they gave her a cortisone shot however that had not helped either. Treatment medications included Cortisone, Hydrocone, Ondansetron, Tramadol and omepr, lidocaine patch on back to help. Outcome of events was not resolved. Additional information has been requested.
43 2021-04-09 tremor, discomfort Upon standing, she felt an extreme heaviness along with feelings like she was going to pass out; hea... Read more
Upon standing, she felt an extreme heaviness along with feelings like she was going to pass out; heart began racing; felt like she was going to be sick; Upon standing, she felt an extreme heaviness; thinks her blood pressure dropped; shaky; her face was completely pale; This is a spontaneous report from a contactable consumer (the patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EP7534), via an unspecified route of administration on 18Mar2021 16:45 (at the age of 43-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: epilepsy, asthma, environmental allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: lamotrigine, montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D), and antihistamine all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 03:00, also reported as 8 hours after vaccine, the patient's heart began racing, she felt like she was going to be sick. Upon standing, she felt an extreme heaviness along with feelings like she was going to pass out (she thinks her blood pressure dropped). She was shaky. Her husband confirmed that her face was completely pale. The patient's heart raced on and off for another half hour before she felt more normal. No treatment was received for the events. The outcome of the events was recovered on an unspecified date in Mar2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
43 2021-04-10 weakness Facial and throat swelling , headache, tiredness Rapid heartbeat, weakness, Wheezing Chills Sweated... Read more
Facial and throat swelling , headache, tiredness Rapid heartbeat, weakness, Wheezing Chills Sweated through 2 outfits Joint and muscle pains
43 2021-04-11 weakness, pain in extremity Tightness in the throat and chest, rash on neck, headache, weakness, pain in shoulders and arms an... Read more
Tightness in the throat and chest, rash on neck, headache, weakness, pain in shoulders and arms and legs feeling to weak to move or lift.
43 2021-04-11 numbness Felt numbness in face the night after receiving first dose as well as the morning after that. Numbn... Read more
Felt numbness in face the night after receiving first dose as well as the morning after that. Numbness left and then moved to swelling, particularly above the eyes, which is more subtle now but ongoing as of 4/12/21.
43 2021-04-11 pain in extremity Headaches, arm pain, intermittent inability to move arm in which she received the vaccine, chills, s... Read more
Headaches, arm pain, intermittent inability to move arm in which she received the vaccine, chills, sweats, and diarrhea
43 2021-04-11 tingling, weakness, numbness, burning sensation 3/24/21 - Spreading heat up left shoulder to left side of Neck 5 mins 3/24/21 - pricking on left elb... Read more
3/24/21 - Spreading heat up left shoulder to left side of Neck 5 mins 3/24/21 - pricking on left elbow slightly itchy 3/24/21 - 5:05PM - Intense pricking around browbone and cheeckbone on face - tightening of skin on cheeks with heat feelings 3/24/21 - pricking on elbows Left and Right- skin sensitization over body- random pricking on varius areas of body 3/25/21 - Continues - tingling begins in both forearms and legs; Chest pain right pectoral area 3/26/21 to date - numbness on face; tingling of entire left leg; pinpricks across shouldrs upper chest Pain on forerms ; fullness in ears Weakness and heaviness in both arms; fatigue
43 2021-04-11 tingling Fever, chills, aches, pains - started evening of 4/5 Horrible Paresthesia arms, legs, feet - still h... Read more
Fever, chills, aches, pains - started evening of 4/5 Horrible Paresthesia arms, legs, feet - still happening on 4/12
43 2021-04-12 feeling of body temperature change Pt complain of fast heart beat feeling hot then cold. Patient was taken by ambulance to ER
43 2021-04-12 numbness Within 10 minutes facial numbness to the left lip and cheek area. Felt like rubber and lasted for ab... Read more
Within 10 minutes facial numbness to the left lip and cheek area. Felt like rubber and lasted for about an hour. Reappeared 2 days later and lasted a few hours.
43 2021-04-12 migraine Sudden multiple occurrences of ocular and retinal migraines - visual aura, have had 6 episodes since... Read more
Sudden multiple occurrences of ocular and retinal migraines - visual aura, have had 6 episodes since the first vaccine (2 after the first dose) and already 4 after the 2nd dose. I haven't had ocular migraines since 2010 associated with mold exposure and when I moved, they went away. Now, suddenly, with no other changes except for receiving the vaccine, I am getting them more than 1x/week.
43 2021-04-12 pain in extremity, migraine Pain in left arm where shot was administered. Began the morning after received the vaccine. Migrain... Read more
Pain in left arm where shot was administered. Began the morning after received the vaccine. Migraine-like headache and flu-like discomfort (coughing, chills) began later that evening. Did not sleep at all on the 2nd night. Chills and headache are still present.
43 2021-04-12 pain in extremity Continuous arm/muscle pain beggining from injection site to upper left shoulder. Can no longer full... Read more
Continuous arm/muscle pain beggining from injection site to upper left shoulder. Can no longer fully lift or hold heavy items with left arm painlessly. Pain is throbbing and worse at night making it difficult to sleep. Anti-inflammatory over the counter medicine, salon pass and lidocaine rubs do not help with pain.
43 2021-04-12 tingling, numbness After I had my first vaccine I had muscular issues. I just had my second vaccine and I am now having... Read more
After I had my first vaccine I had muscular issues. I just had my second vaccine and I am now having numbness and tingling in my fingers.
43 2021-04-12 seizure seizure like episode ER visit following up with neurology may have been febrile seizure
43 2021-04-12 tremor Received the vaccine at 12 on April 10th. Went to sleep around 11pm that night feeling pretty normal... Read more
Received the vaccine at 12 on April 10th. Went to sleep around 11pm that night feeling pretty normal and after taking one dose of acetaminophen, just in case as I've been told may people were experiencing high fevers after the 2nd dose. Woke up at 2am with high fever (sorry, never actually took my body temp), chills, uncontrollable body shakes, body aches and extreme nausea. Went back to sleep around 5am. Woke up around 10am on April 11th with 99.9 body temp. Took more acetaminophen and ibuprofen to control the body aches and fever. Spent the day in bed on April 11th, with very little appetite and flu like symptoms. Gotten progressively better throughout the day but never felt quite right. On April 12th, was still feeling tired and had some muscle aches but was overall feeling much better. Noticed the lymph nodes under my left armpit (I received the vaccine in the left arm) were quite tender to the touch. Was able to resume normal activities but didn't feel like I was quite ready to go to the gym. On April 13th, feeling normal, finally, aside from the tenderness of the lymph nodes (left armpit).
43 2021-04-13 weakness, pain in extremity Arm pain on the first and second day Acute waist on the second to the third day and other spontaneou... Read more
Arm pain on the first and second day Acute waist on the second to the third day and other spontaneous body aches, weakness. Allergic reaction in feet and legs on the fifth day as if they were insect bites.
43 2021-04-13 feeling cold, feeling of insects crawling on skin Arm turned deep red purple after a few minutes, felt has ants all over me, felt Rush of cold freezin... Read more
Arm turned deep red purple after a few minutes, felt has ants all over me, felt Rush of cold freezing through stomach up through chest and back lower to upper back, felt as if cotton was being packed into my throat. After a few more minutes difficult to swallow. Dr. administered Epi shot, was sent to ER where was administered IV meds, prescribed at home allergy meds. ER follow-up last Thursday with primary Dr. , extended prescribed allergy meds for additional month due to ongoing symptoms.
43 2021-04-13 feeling hot PT RECEIVED COVID 19 SHOT ON 4/13/21 AT SEPARATE LOCATION. PATIENT FELT WARMING SENSATION IN HER THR... Read more
PT RECEIVED COVID 19 SHOT ON 4/13/21 AT SEPARATE LOCATION. PATIENT FELT WARMING SENSATION IN HER THROAT WITHIN 15 MINUTES OF VACCINATION BUT WAS DISCHARGED HOME; A SHORT TIME AFTER THAT SHE BEGAN TO HAVE TROUBLE BREATHING WHICH INCREASED THROUGHOUT THE NIGHT DESPITE USING HER INHLAER AND NEBS MULTIPLE TIMES. PT ARRIVED TO EDMORNING OF 4/14/21 WITH SHORTNESS OF BREATH AND WHEEZING. PT GIVEN IV STEROIDS IN ADDITION TO NEBULIZER TREATMENTS. AFTER SEVERAL NEBULIZER TREATMENTS, PT RESPIRATORY STATUS STABILIZED AND WAS ABLE TO BE DISCHARGED HOME.
43 2021-04-13 migraine, facial pain Costochondritis began March 23. March 26 terrible migraine set in. It was the worst one I?ve ever ha... Read more
Costochondritis began March 23. March 26 terrible migraine set in. It was the worst one I?ve ever had. Head felt like it was being crushed on both sides, extreme nausea, dry heaving, and pain all over head, back of eyes, neck, shoulders, and face. This migraine continued on and off for almost two weeks, required ER visit, Dr visits, IV steroids, IV NSAIDs and injections, and other migraine medications. The headache continued for over 2 weeks, specifically on left side of head and face near temple and side of head and left side of forehead. I?ve been on prednisone between 30-20mg daily for this. I am 24 days passed receiving first shot and still have mild pain on left side. I am still recovering.
43 2021-04-13 muscle spasms Depression, exhaustion, insomnia, edema, brain fog, bloating, constipation, lower back pain, muscle ... Read more
Depression, exhaustion, insomnia, edema, brain fog, bloating, constipation, lower back pain, muscle fatigue, muscle cramping
43 2021-04-13 muscle twitching Within the first 10 minutes of the injection I got a strong twitch in my arm at the injection site. ... Read more
Within the first 10 minutes of the injection I got a strong twitch in my arm at the injection site. It was sudden and did not last more than a few seconds. After about 30 minutes my face began tingling on the right side. I had Bells Palsy about 3 years ago and it was reminiscent of that event. Luckily it only lasted about an hour.
43 2021-04-13 pain in extremity, cold extremities, feeling hot 4/7-4/8: 101.8 fever 4/9 through current day: Autoimmune reaction - fingers are sore, swollen, itchy... Read more
4/7-4/8: 101.8 fever 4/9 through current day: Autoimmune reaction - fingers are sore, swollen, itchy, white and red, cold and hot. Treatment: Dr. visit on 4/13, prescribed prednisone and nifedipine to reduce/relieve inflammation and constricted blood vessels in fingers. Time course: 4/9/21 through current day
43 2021-04-13 pain in extremity Sore arm
43 2021-04-13 pain in extremity Same day, period started. Wasn't due yet. Full period for 8 days, now day 15 and still spotting. Usu... Read more
Same day, period started. Wasn't due yet. Full period for 8 days, now day 15 and still spotting. Usual period 3 to 4 days and is light. Swollen, hot, itchy and painful injection site on the 4th day. Arm only ached overnight. On the 12th of April, not sure if related, body itchiness.
43 2021-04-13 tingling, weakness Immediately after the shot, I started to have blurry vision, dizziness, rapid heart beat and sweatin... Read more
Immediately after the shot, I started to have blurry vision, dizziness, rapid heart beat and sweating, almost collapsed in the arms of the nurse although I was seated. Could not stand or walk. The nurses attended to me, by giving me water and sugar and calming my breathing. After a few minutes one of the nurses took me for a walk around the facility and recommended I take Benadryl. They kept an eye on me for about 1h and a half until I was in some shape to drive back home. Driving was very difficult, as I was still fairly dizzy and weak. During the day I would get bursts of dizziness, tingling in the face and unusual heart palpitations. In the evening I got shivers and dizziness. I was fine the next day.
43 2021-04-14 weakness, tremor This was my second dosage of the Pfizer vaccine. Upon the first vaccine, I did feel symptoms of thro... Read more
This was my second dosage of the Pfizer vaccine. Upon the first vaccine, I did feel symptoms of throat swelling and difficulty swallowing that subsided without intervention and quickly. For the second vaccine that I received today, I experienced dizziness in the store and began to sweat. I left because the pharmacy staff did not seem to want to be bothered. Upon driving home, within about 15 minutes of getting the vaccine, I began to have nausea to the point that I had to stop and pull over. I vomited a small amount of my breakfast. Continued to feel shaky, dizzy, faint, excessive saliva and tearing of eyes. Upon arriving in my driveway, it was hard to walk up stairs. The nausea continued for about 1.5 hours but the weakness and feelings of faintness continue still after 2 hours after the vaccine. I had some tachycardia. It's hard for my eyes to look up and my eyes hurt when I move them. I had moments of feeling like I had a parietal vice on my head. I called the pharmacy to report all of this and only spoke with a pharmacy assistant. No pharmacist called to check on me. I am an RN so I have the knowledge needed to care for myself and seek medical attention if needed, but I have sympathy for those that are not and have their report of symptoms dismissed just as I did from the vaccine provider.
43 2021-04-14 cold sweat Situation: The patient is receiving her second Pfizer Covid vaccine today. Background: N/A Assessmen... Read more
Situation: The patient is receiving her second Pfizer Covid vaccine today. Background: N/A Assessment: After receiving the vaccine the patient states she is not feeling well. Looks clammy. Doctor is walking the patient to the Observation room. Patient was positioned on a gurney in a Trendelenburg position. Vital signs at 1420: 136/88, 76, 14, 98% on RA. The patient is in no acute distress. 1430: The patient was placed in supine position. Vital signs: 117//80, 67, 12, O2 Sat 98 % on RA. Doctor informed Recommendation: The patient states she feels back to normal. She is sitting up on the side of the gurney. Per doctor the patient was discharged from the clinic.
43 2021-04-14 facial pain Pain and swelling lips, and several areas of the face (swelling and pain in lips, pain only in face)... Read more
Pain and swelling lips, and several areas of the face (swelling and pain in lips, pain only in face) both sites, only where she has had filler (filler name unavailable Restylene or Juvaderm??).
43 2021-04-14 feeling jittery, tremor, pain in extremity After receiving the first shot I had normal side effects - a headache that went away in 24 hours and... Read more
After receiving the first shot I had normal side effects - a headache that went away in 24 hours and a sore arm that lasted 36-48 hours. I did notice a slight jitter/shaky feeling and a little tinitus. One week later the tinitus became much louder and continual. This has continued for a week. I also have moments of vertigo and an overall achy/tired feeling that I have been in bed for the past 4 days.
43 2021-04-14 flushing I think the rash started the night of the vaccination (Monday) and then progressively got worse (tod... Read more
I think the rash started the night of the vaccination (Monday) and then progressively got worse (today is Thursday). The rash is on my face (cheek area); my face is flushed and slightly itchy. I'm applying ice and I just took a benedryl, hoping to stop it from getting worse. I called my doctor and she said this reaction could definitely be from the vaccine.
43 2021-04-14 migraine with aura Migraine with aura without headache (diagnosed by medical professional). Visual disturbance for abou... Read more
Migraine with aura without headache (diagnosed by medical professional). Visual disturbance for about 20 minutes. Slightly elevated blood pressure.
43 2021-04-14 migraine, tingling Ocular migrane, tingling in left arm, chills, nausea, exhaustion, headache for two days, diarrhea.
43 2021-04-14 pain in extremity Extreme muscle aches Fatigue Headache Chills Very sore arm
43 2021-04-14 pain in extremity Light headedness-still experiencing 3 days letter, fatigue-2 days later, arm sore for the next day,... Read more
Light headedness-still experiencing 3 days letter, fatigue-2 days later, arm sore for the next day, headache.
43 2021-04-14 pain in extremity Painful swollen lump the size of a pea just above left collar bone (same side as vaccine shot in arm... Read more
Painful swollen lump the size of a pea just above left collar bone (same side as vaccine shot in arm).
43 2021-04-14 pain in extremity Extreme headache, body ache, arm sore, my mouth has a metallic taste and can not taste salt.
43 2021-04-15 weakness, tremor, numbness caller says she is shaking, has trouble breathing. weak and cant stand up it started the day after t... Read more
caller says she is shaking, has trouble breathing. weak and cant stand up it started the day after the shot. the 4th day she couldnt sleep fever was 37.7 every day has good days and bad days now she cant function after getting the shot. adv go to hcf.....or contact your PCP.....or try telehealth. she doesnt want to since she has been there 3 times, it cost a lot of money she has had sx on and off for 3 month, her sx had mostly disappeared except for weakness. she has had fatigue for months, diarrhea 50 times a day treated in hcf for dehydration, had kidney infection then it went to my heart. ....couldn't feel legs or hands, she can walk after month 5 or 6, the soles of her feet hurt, she has pain in her toes. denies wt loss sx change from top of body to lower body caller doesnt think that people who had covid should have the vaccine
43 2021-04-15 feeling cold, cold sweat I began experiencing a headache first around 10pm. Then I got the chills around 11pm and had to put... Read more
I began experiencing a headache first around 10pm. Then I got the chills around 11pm and had to put on multiple layers of clothing to be able to fall asleep. I woke up around 10 am with muscle aches, still exhausted and nausea when I stayed on my feet for too long. I slept again from 2pm to 6pm. I took two Tylenol before I went to bed at 10 pm and broke into a cold sweat. On 4/16/2021 I woke up around 9am and I feel much better. A little headache, but I have energy and no muscle aches or chills.
43 2021-04-15 numbness, mild one side paralysis Patient developed L sided weakness and numbness on 4/15/21, and was found to have a transient ischem... Read more
Patient developed L sided weakness and numbness on 4/15/21, and was found to have a transient ischemic attack.
43 2021-04-15 numbness, pain in extremity Pain in lower left leg and foot. Foot and toes are numb.
43 2021-04-15 tingling pt reported tingling sensation on R arm and fingers (pinky, ring, middle) on ulnar side of arm, star... Read more
pt reported tingling sensation on R arm and fingers (pinky, ring, middle) on ulnar side of arm, starting at 10:15am. BP at 10:15am was 105/55, 99% o2 sat, HR 71. Pt reported pain radiating from original site of tingling to upper shoulder, neck and lower back. Pt. had hx of spinal surgery 1.5 yrs ago. taking tramadol, gabapentin and ibuprofen PRN pain r/t spinal surgery pain. last time of taking tramadol and gabapentin was 1 wk ago. ibuprofen last taken previous evening. Had verbal report from assisting nurse, unknown, stating pt. had systolic BP of ~156. At 10:25am charge nurse RN retook BP with manual BP cuff, and got 150/100. Pt. stated pain was continuing, not lessening over time. Staff called EMS at 10:30am. Immediate arrival. EMS assessed pt, cleared her to go home, and stated she should f/u with her primary if sxs continue, and to call 911 if sxs get worse. Offered pt. choice to wait on premises for longer, or to go home and do self-care with family at bedside. Pt. opted to go home. Two relatives in front seat stated they would stay with pt. Pt. given aftercare instructions such as to rest, relax, drink water, and mobilize vaccinated arm for less soreness. Pt. left by 10:45am.
43 2021-04-15 speech disorder, slurring, discomfort Was talking with husband and commented that I felt a wave of tired coming over me. Immediately follo... Read more
Was talking with husband and commented that I felt a wave of tired coming over me. Immediately following the statement I was having difficulties speaking, slurred speech, and my body felt weighted. This lasted 2 minutes. This experience happened two more times so we left for the ER. Another episode happened while checking in the ER and they responded as if I was having a stroke. A 5th episode happened while in the ER waiting for a room and a 6th time after admission in the room with a nurse. This last episode was at 1:00pm on 3/5/2021. I could feel each of these coming on.
43 2021-04-15 tremor, feeling hot pt felt fine until ready to go felt lightheaded and hot. pt placed on floor began to shake for a f... Read more
pt felt fine until ready to go felt lightheaded and hot. pt placed on floor began to shake for a few seconds and laid flat with feet elevated pt started to feel better and placed on stretcher to OBS for further evaluation. pt in OBS feeling better given water and crackers tolerating well. denies further symtpoms. vs as noted. dr at bedside reviewed bp pt sitting up then dangling then standing at side of bed tolerated well feeling better pt okay to leave ambulated to exit without difficulty at 1544 VS 1525 bp 132/80 hr 98 rr 14 o2 99, 1535 bp 149/84 hr 73 rr 16 o2 100 1540 bp 124/70 hr 75 rr 16 o2 100
43 2021-04-15 tremor, tingling Patient had a severe shaking experience. It lasted about 5 minutes. Not a seizure but very similar... Read more
Patient had a severe shaking experience. It lasted about 5 minutes. Not a seizure but very similar. Patient was aware during the experience. very disoriented afterwards. Patient said she had tingling in her head. which lasted about 1-2 hours.
43 2021-04-16 burning sensation burning on my thigh like a rash is about to break out
43 2021-04-16 difficulty speaking Tickle in throat, cough, throat clearing started approximately 10 minutes after injection. After abo... Read more
Tickle in throat, cough, throat clearing started approximately 10 minutes after injection. After about 40 minutes of these symptoms , received Benadryl 50 mg po, symptoms continued, tachycardia and tachypnea developed and worsened to near continuous cough, hoarseness/laryngitis, tachypnea, tachycardia, nausea, dry heaves, difficulty swallowing, trouble catching breath over next 30 minutes or so. Received solumedrol 125 mg IV, epinephrine im x2, Pepcid IV, racemic epinephrine neb, epinephrine gtt starting at 0.05 mcg/kg/min. After 2nd IM epinephrine, symptoms slightly improved. After approximately 1h on gtt, was able to be decreased to 0.02 mcg/kg/min and then turned off after another 30-60 min.
43 2021-04-16 pain in extremity Low grade fever, chills, fatigue, arm soreness, visibly swollen armpit under left arm. Armpit pain b... Read more
Low grade fever, chills, fatigue, arm soreness, visibly swollen armpit under left arm. Armpit pain began approx 36 hours after receiving injection. Other symptoms began approx 20 hours after receiving injection. Armpit pain was present after first injection but at the time did not realize it was related to vaccine until symptoms appeared more severely after second dose.
43 2021-04-17 inability to speak, speech disorder aphasia; difficulty speaking; Jaw: Trismus; This is a spontaneous report from a non-contactable othe... Read more
aphasia; difficulty speaking; Jaw: Trismus; This is a spontaneous report from a non-contactable other healthcare professional. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 24Mar2021 (batch/lot number: ER8727) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 24Mar2021 during her 15 minute waiting period after the injection, the patient began to experience difficulty speaking. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Jaw: trismus present. Treatment included: no therapy. Follow up response to treatment: no change. Patient transported to ED by ambulance. Differential diagnosis: systemic reaction (hypoglycemia, hypotension, generalized rash) and red flag symptoms (CP, SOB, NVD, visual/neuro concerns). Patient with no other neuro deficits but aphasia was clearly present. AMR called to have patient brought to ED for further evaluation. Husband, will meet her there. The report was assessed as non-serious. The outcome of the events "difficulty speaking" and "trismus" was not recovered; and unknown for aphasia. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The company cannot completely rule out a reasonable possibility that BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) caused the aphasia (speech disorder) and trismus due to a reportedly close drug event chronological association. Information on further evaluation would be necessary for a more meaningful medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-04-17 bell's palsy Bells palsy; Metal taste in mouth, mild on first afternoon but stronger tasting on next two days; he... Read more
Bells palsy; Metal taste in mouth, mild on first afternoon but stronger tasting on next two days; her body started to feel strange/ just felt weird; This is a spontaneous report from a non-contactable consumer (patient). A 43-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in left arm, on 12Mar2021 at 02:30pm (at age of 43 years old), as a single dose, for COVID-19 immunisation. Medical history included migraine and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ondansetron (ZOFRAN) and oxymetazoline hydrochloride (CLARITIN ALLERGIC), Nurtec and allergy immunotherapy; all started on an unspecified date and for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the BNT162b2 vaccine. On 12Mar2021 (at 6:00pm), the patient experienced a metal taste in her mouth, mild on first afternoon but stronger tasting on next two days. On Day 2, it was reported that her body started to feel strange, could not quite describe feeling, further described as it was not really a tired feeling or a painful feeling, just felt weird. On 25Mar2021, the patient experienced Bells palsy. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the events metal taste in her mouth, body started to feel strange/just felt weird. The clinical outcome of the events, metal taste in her mouth, body started to feel strange/ just felt weird, was recovered on an unspecified date. The clinical outcome of the event Bells palsy was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
43 2021-04-17 feeling cold, numbness, migraine Numbness in head and extremities with a cold feeling, migraines.
43 2021-04-17 numbness, tingling Lips tingling numbness left side face tongue, pin and needs hands feet
43 2021-04-17 numbness, cold extremities, tension headache, tingling Paresthesia over entire body. Legs felt numb if sitting still/as if they are not attached to body. ... Read more
Paresthesia over entire body. Legs felt numb if sitting still/as if they are not attached to body. Extreme cold in hands and feet. Redness over all skin. Head tension and aches. Started approximately 10 hours after 2nd vaccine injection. Still lingering into 2nd day. Have lessened. Legs still feel numb/not fully attached at times.
43 2021-04-17 nerve pain, numbness, feeling cold, cold extremities, tingling, pain in extremity Initially - expected sore arm .. went away day 7 .. Day 2: 1/2 my face went numb like I received de... Read more
Initially - expected sore arm .. went away day 7 .. Day 2: 1/2 my face went numb like I received dental work ? it lasted 3 hr .. went away but not completely? still have some facile tingling on the right side and numbness .. on day 13 / 14 body ache - fatigues - just tired ? Had covid test on 4/12 - negative On 4/13 extremities feeling cold - chest feeling ice cold ... fatigue and muscle pain - neurologists facial symptoms of tingling 4/16 was schedule for my 2nd vaccine shot but they told me to hold off another wk bc of my symptoms... so that Friday and now today I?m just exhausted - body aches - muscle pain - joint pain ? burning neurological pain in my extremities and just muscle pains in large groups ...
43 2021-04-17 pain in extremity, migraine This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number ER8730, Expiration date: 31Jul2021), via an unspecified route of administration on 30Mar2021 at 10:00 (at the age of 43-years old) as a single dose in the right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No lab test was performed. Prior Vaccinations (within 4 weeks) and other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as None. Patient has a few concerns, states that patient and her husband got the first dose of their Pfizer vaccines 3 days ago, on 30Mar2021, states patient is experiencing typical side effects listed like headaches and not feeling well, clarifies she turned beet red in the face right after the vaccine and sore in arm on 30Mar2021, patient had a migraine on one side of her head, felt throw uppy, woke up with a sore throat and was coughing up blood on 02Apr2021. patient states she treated herself this morning with Excedrin migraine and has completely resolved. Patient states her throat is still sore but she is no longer coughing up blood. As per the reporter seriousness criteria for the event (coughing blood) was medically significant. The outcome of the event Sore throat was not recovered, coughing blood was recovered on an unspecified date in 2021, Pain in arm, migraine, vomiting was recovered on 02Apr2021, Face red was recovered on 30Mar201 and unknown for another events. No follow-up attempts are needed. No further information is expected.
43 2021-04-17 tremor Pfizer-BioNTech COVID-19 Vaccine EUA First symptom on 4/16/21 at 12:30 am was skin becoming sensitiv... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA First symptom on 4/16/21 at 12:30 am was skin becoming sensitive to the touch and difficulty sleeping. In less than an hour, chills began with shaking all over my body. Nausea began shortly afterward with a headache in the front of the head. Took 1 extra strength Tylenol and 2 chewable Tums. Extra blankets eventually helped with chills, nausea subsided after a couple of hours. Woke up around 5:00 am with a severe headache like a band all around my head. Took 1 ibuprofen. Headache eventually became mild around 9:00 am. During the daytime on 4/16/21, I experienced fatigue, muscle weakness, muscle soreness, fogginess, mild headache, and difficulty staying warm. I took ibuprofen during the day to help with pain/headache. On 4/17/21, I experienced muscle weakness/pain and fatigue. On 4/18/21, I continued to experience fatigue and mild muscle weakness. I am still unable to exert myself with any amount of energy.
43 2021-04-18 breast pain Pain , tenderness and small palpable bumps on left axilla & pain and tenderness on lateral side of... Read more
Pain , tenderness and small palpable bumps on left axilla & pain and tenderness on lateral side of left breast.
43 2021-04-18 migraine, pain in extremity right after the vaccine, I had heart palpitation and a headache but I thought it was my anxious acti... Read more
right after the vaccine, I had heart palpitation and a headache but I thought it was my anxious acting up. Later that night, my arm became quite sore but I got itchy and the headache became a severe migraine so I took a Tylenol and the Rizatriptan 4 hrs later. The following day, I could not get out of bed with severe body ache, light headedness, heart palpitation and slight difficulty breathing. I have been in bed since but the heart palpitation and more difficulty breathing and wheezing are intermediate but strong at onset. I am also still itchy.
43 2021-04-18 pain in extremity, burning sensation, numbness, numbness and pain in extremities, tingling Second dose of vaccine received on March 10, 2021. Thereafter I started having severe lower back pai... Read more
Second dose of vaccine received on March 10, 2021. Thereafter I started having severe lower back pain. The pain radiated to my quads, down to my shins and feet. The pain circulates throughout the lower half of my body. Symptoms include: Dull Achy pain, pins and needles, numbness, burning sensation. Because of the pain I cannot sleep at night. I have been to the emergency room 4 times for the severe pain. During my last visit I was admitted to the hospital. Running Diagnosis is : Covid Vaccine Induced Neuropathy.
43 2021-04-18 seizure Pt had seizure and went to the emergency room
43 2021-04-19 feeling cold My shot was at 3:30p last Wednesday; I started feeling sick (nausea & generally cold) around 11:30 ... Read more
My shot was at 3:30p last Wednesday; I started feeling sick (nausea & generally cold) around 11:30 am on Thursday. By 1pm on Thursday my fever was ratcheting up & I couldn?t control the chills (had on thermals & in bed under 3 blankets)?.that lasted until about 7-8 pm and then my fever shot up to 101.5 (but chills went away) and stayed there until Friday morning around 6am. By 1 pm on Friday, I was 100% better.
43 2021-04-19 feeling hot, tingling Within minutes of receiving the shot my left ear started to turn red, hot and tingly. This is simila... Read more
Within minutes of receiving the shot my left ear started to turn red, hot and tingly. This is similar to how I react to shellfish which I have severely allergic to. The redness and hives then spread from the left cheek over my nose to the right side of my face and down my neck. I was then taken to an ambulance and treated by an EMT. I was advised to either be given an antihistamine cocktail via IV or be released and take it at home. I chose to go home since I was driving myself and knew that the drugs would make be very tired and impossible to drive safely. I took the dose as soon as I returned home and then 6 hours later took a second dose as the hives were still appearing on my face. The next day, April 2, I woke without symptoms.
43 2021-04-19 migraine with aura Migraines with aura every afternoon since the vaccine.
43 2021-04-19 pain in extremity fatigue (started about 6 hours after shot, lasted for about 2-3 days), dizziness (started about 6 ho... Read more
fatigue (started about 6 hours after shot, lasted for about 2-3 days), dizziness (started about 6 hours after shot, lasted for about 3 days), heart palpitations (experienced it for 2 nights starting on second night after shot, lasting for a few minutes), sore arm (started about 4 hours after shot, lasted 4 days)
43 2021-04-19 tingling Tingling in chest "tight" in chest. Tingling hands. Hypertensive crisis with dizziness. Evaluated by... Read more
Tingling in chest "tight" in chest. Tingling hands. Hypertensive crisis with dizziness. Evaluated by EMS- Transported to Emergency room/department or urgent care.
43 2021-04-20 feeling hot, pain in extremity I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to ... Read more
I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to where I got the shot/ like whenever I take a step to walk it's feels like my head is going to explode; really bad back ache; My face and my back started getting like hot, like heat, like very hot reaction/like radiating heat in my back it is like surrounding my spine, its right in the middle of my back; It feels like heat and pressure around my spine area; high pressure behind the right eye; My arm started hurting; the arm I got the shot in; This is a spontaneous report received from a non-contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733), intramuscular (reported as in the muscle) in left arm on 01Apr2021 (at the age of 43-year-old) at 0.3 ml, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that initially, right afterward she meant her arm started hurting which was normal the arm she got the shot in, she wasn't worried about that. But then her face and her back started getting like hot, like heat, like very hot reaction. She did not know how to describe it, it was like radiating heat in her back it was like surrounding her spine, it was right in the middle of her back. It felt like heat and pressure around her spine area. And in her head, it had not lit up. She had headache so badly that her right eye which was to the opposite side to where she got the shot. She had very high pressure behind the right eye. It was literally like whenever she took a step to walk it was felt like her head was going to explode. It was for her a headache and really bad back ache. When paraphrased the above concern, patient stated It was for days at the time of this report. First adverse reaction was on the actual day that she received the vaccine that was 01Apr2021. Second shot was reported as 29Apr2021. When probed for if patient still experiencing adverse event patient stated that she was still experiencing. As per outcome of event patient stated for its persisting. As per treatment she took an ibuprofen (ADVIL) for the first-time last night before the present report. Just because she needed to get sleep. She had not slept in days. So, she took ADVIL to get rid of the pain last night that was only the things she had done since Thursday 01Apr2021. But it didn't even work. She woke up and felt the exact same. Dose of Advil was reported as 200 mg, she took one 200 mg tablet. She just took it the day before the present report (04Apr2021). The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
43 2021-04-20 feeling hot Patient came in to get a vaccine and patient said she has a history of fainting when getting vaccine... Read more
Patient came in to get a vaccine and patient said she has a history of fainting when getting vaccines. She said she really wanted to get the vaccine even though she might faint again. I gave the patient a shot and she said she did not immediately have any dizziness or lightheadedness. About 10 minutes later, the patient was waiting in the waiting area when it was reported that she might have been having a reaction. When I went to check on her, her skin looked pale and she had her head drooped. She said she felt hot and it looked like she was sweating. I offered the patient some water and told her to drink the water and stay seated. She did not have any trouble breathing or swelling of the mouth or throat. When I checked on her again a couple of minutes later, the color in her skin came back and she said she felt a lot better. I asked if she might have fainted and she said she did not know. I told her to stay seated and rest. I checked on her every 5 minutes after and she looked better so she left.
43 2021-04-20 flushing Within a few hours of receiving my second vaccination, I felt itchy and my face became very flushed.... Read more
Within a few hours of receiving my second vaccination, I felt itchy and my face became very flushed. As the day has progressed, my face has developed little bumps on my forehead, and remains very flushed, I also have a few bumps on my arm, and my equilibrium feels off.
43 2021-04-20 flushing Approximately 5 minutes post vaccination at the county public health center drive through vaccine cl... Read more
Approximately 5 minutes post vaccination at the county public health center drive through vaccine clinic while patient was in the observation parking area the patient beeped her horn and indicated to staff she did not feel well. She had flushing of skin of the chest, and a cough that was just starting. EMS was called at 12:07 PM, and per standing order RN administered 50 mg of Benadryl intramuscularly in the right deltoid at 12:08 PM. The patient progressed to persistent coughing, wheezing, and difficulty talking stating she felt like a lump in her throat and tightening in her throat. Again, following standing order RN administered 0.3 mg of Epinephrine in the left thigh intramuscularly at 12:14 PM. EMS arrived by ambulance at 12:17 PM. Patient was stable upon EMS arrival with all signs/symptoms of allergic anaphylactic reaction gone. EMS evaluated patient and patient signed declination to go to the hospital for evaluation. She remained on site until 12:41 PM when her father / mother came to pick her up from the vaccine clinic site. Follow up was done with patient on 04-21-2021 @ 11:30 AM. She states that no further reaction occurred, and she took no further medications.
43 2021-04-20 numbness My tongue went numb, my left arm went numb, my throat tightened up, my blood pressure and heart rate... Read more
My tongue went numb, my left arm went numb, my throat tightened up, my blood pressure and heart rate went way up, I had a hard time swallowing, dry mouth, tight chest
43 2021-04-20 migraine, pain in extremity, numbness and pain in extremities Worsen neuropathic symptoms; migraine headache; Sore arm; fatigue; low grade fevers; chilled; This i... Read more
Worsen neuropathic symptoms; migraine headache; Sore arm; fatigue; low grade fevers; chilled; This is a spontaneous report from a contactable consumer(patient). This is the 1st of 2 reports, for the Second dose. A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 24Mar2021 (at age of 43 years old) 11:45AM, via an unspecified route of administration, administered in Arm Left (Batch/Lot number was not reported) at single dose, for covid-19 immunisation. Medical history included Ovarian cancer, blood clots, hypertension. known allergies Salfa. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 03Mar2021 (at age of 43 years old) 11:00 AM, via an unspecified route of administration, administered in Arm Left (Batch/Lot number was not reported) at single dose, for covid-19 immunisation and experienced Sore arm, Worsen neuropathic symptoms (existing side effects from chemo) - pains on fingers, wrists, feet, toes, back# fatigue, migraine headache for 15 days. Concomitant medication(s) in two weeks included duloxetine hydrochloride (CYMBALTA) 30 mg, warfarin 1mg and hydrochlorothiazide, all taken for an unspecified indication, start and stop date were not reported. Sore arm, Worsen neuropathic symptoms (existing side effects from chemo) - pains on fingers, wrists, feet, toes, back# fatigue, migraine headache for 15 days after the first dose. For second dose, same symptoms continuously for 11 days now and low grade fevers, chilled for first 4 days after the vaccine and on the 11th and 12th days after the second dose. No treatment received for events and The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19. Outcome for events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377679 Same patient/drug, diff event sep for different doses.
43 2021-04-20 migraine Hands and feet felt arthritic, nausea before eating, all over body & joint pain, then a debilitating... Read more
Hands and feet felt arthritic, nausea before eating, all over body & joint pain, then a debilitating migraine that lasted all day, sinus pressure in ears, around eyes, lethargy
43 2021-04-20 pain in extremity On day 5 following my first vaccine, I woke up with hives on my neck, scalp, arms, hands, abdomen. I... Read more
On day 5 following my first vaccine, I woke up with hives on my neck, scalp, arms, hands, abdomen. I was given a steroid injection and daily steroids, took benadryl, pepcid, and allegra. On day 7 following the vaccine, I woke up in the middle of the night to joint pain, excruciating pain in both hands - I would describe it like carpal tunnel issues in my wrist and hand. It hurt to touch of a bedsheet, it hurt to move the hands in anyway. I went to ER for labs and checkup. It was unclear but I had some type of inflammation in my joints of the hand and wrist. That lasted until day 10 and then on day 11, I woke up in middle of night with the same pain in my right foot. It radiated pain up my heel around my ankle from the touch of the bedspread and any movement I made. That lasted until day 14-15. Then I seemed fine.
43 2021-04-20 tremor Patient felt anxious after vaccine administration about 5 minutes after dose given. Tremors in hands... Read more
Patient felt anxious after vaccine administration about 5 minutes after dose given. Tremors in hands. No difficulty breathing or swelling. Patient states she gets anxious every now and then. Patient monitored for about 30 minutes. She felt "better" and was able to get up and leave when she felt comfortable.
43 2021-04-21 weakness, muscle spasms Patient had weakness, fatigue, muscle cramping and nausea that lead to hospital admission.
43 2021-04-21 weakness Weakness, nausea, extreme dizziness, vertigo, pain in ear, tinnitus, fullness in ear, chills and 99.... Read more
Weakness, nausea, extreme dizziness, vertigo, pain in ear, tinnitus, fullness in ear, chills and 99.6 temperature.
43 2021-04-21 discomfort, pain in extremity Extreme leg pain/ leg muscle stiffness and leg muscle heaviness. I?m a runner and former athlete, a... Read more
Extreme leg pain/ leg muscle stiffness and leg muscle heaviness. I?m a runner and former athlete, and I?ve never experienced anything like this. My legs hurt and felt more fatigued than after I did an Ironman! It started 6 days after the 2nd dose and is still there at day 9
43 2021-04-21 facial pain, tingling, tenderness I had side effects beginning the morning after that lasted 7 full days. they seemed to be the normal... Read more
I had side effects beginning the morning after that lasted 7 full days. they seemed to be the normal side effects; sore arm (injection arm) nausea, headache, body ache, extreme exhaustion, diarrhea, heart palpitations, loss of appetite, upset stomach, brain fog, pain and sensitivity in face and glands. these side effects happened through the 7 days, ending by the evening of the 15th. they were all consistent except the pain in my face and glands only happened a couple times through that week and only lasted a short time each event. HIGH ALERT SIDE EFFECT: on the evening of 4/13 at 11:20 PM. I had been asleep for about 90 minutes, I woke up suddenly with a super rapid heartbeat and acid reflux. my left arm (injection arm) was totally numb, my fingers were tingling and ice cold. I was unable to grasp a phone of hold anything. I tried to shake it off for about 30-45 minutes. I began to panic so I connected to a teledoc via phone. he indicated it COULD be a side effect of the vaccine and to try and get sleep and see if it was still there in the morning. I went to bed again about 2:30AM and woke up at 5:00AM and the sensation was gone and it I was back to normal.
43 2021-04-21 flushing, numbness, pain in extremity About 10 minutes after shot I felt a bit flushed and light headed, then my face felt numb for a coup... Read more
About 10 minutes after shot I felt a bit flushed and light headed, then my face felt numb for a couple hours. I was then just tired on and off with a sore arm. On day 3 I started feeling congested with pulsing in my right ear followed by ringing tinnitus which continues to this day. I have taken Tylenol and ibuprofen a couple times, which doesn?t help much. I am currently over the 7 day mark from first dose.
43 2021-04-21 numbness Client complained of Numbness on the right side of her face/tongue approximately 15-18 minutes after... Read more
Client complained of Numbness on the right side of her face/tongue approximately 15-18 minutes after injection. Client described it as "like going to the dentist". Blood pressure 170/100 during episode. O2 sat 100%, HR 69. She denied shortness of breath and had ho stridor or compromised breathing. Client sat with observer for another 15-20 minutes, and stated that the symptoms were going away. She stated that her mother is a nurse and she would have her mom bring her to the ER if symptoms worsened.
43 2021-04-21 pain in extremity, weakness Feeling of sudden faintness with increased heart rate and breathing rate, and feeling of inflamed si... Read more
Feeling of sudden faintness with increased heart rate and breathing rate, and feeling of inflamed sinuses. Faintness, heart, and breathing lasted acutely for about 30 minutes. After that sore arm, weakness, tiredness, and headache lasted for several days. Inflamed sinuses and sinus pressure recurred for more than a week after the shot.
43 2021-04-21 pain in extremity I had a sore arm right after vaccine but it was severe and didn't last long. On the 13th, I had som... Read more
I had a sore arm right after vaccine but it was severe and didn't last long. On the 13th, I had some unusual vaginal discharge. Went to the hospital to be evaluated for pre-term labor. I was having early contractions. I spent a week in the hospital. There were enough contractions last night that I came back in to be evaluated to do. Today I'm getting observed at the hospital - not sure if they will admit me or not. Pregnancy history - 2nd pregnancy; 1st - live birth at 34 weeks - she spent a week at NICU but is doing great now. Projected due date is July 13, 2021 for this pregnancy.
43 2021-04-21 pain in extremity Systemic: Had behind the arm, through the armpit and side. and throughout arm. thinking maybe the ra... Read more
Systemic: Had behind the arm, through the armpit and side. and throughout arm. thinking maybe the radial nerve was hit-Medium
43 2021-04-21 pain in extremity 5 days after both the first shot and the last shot, I had sever lower leg swelling and pain so much ... Read more
5 days after both the first shot and the last shot, I had sever lower leg swelling and pain so much so that I went to Urgent Care to get scanned for blood clots. I did not have blood clots. The pain and swelling lasted for almost a week after the first shot. I am on onset of the swelling for the 2nd shot.
43 2021-04-21 tingling Right eye lower lid twitching started about a week after vaccine and still continues to this day - 3... Read more
Right eye lower lid twitching started about a week after vaccine and still continues to this day - 3 months after second vaccine. I have seen an optometrist and neurologist. I have tried eye drops for dry eye and for allergies with no relief. I also have a tingling that comes and goes on my right cheek.
43 2021-04-22 weakness Patient almost immediately experience tachycardia (98-101), nausea, weakness, feeling of feverish Ou... Read more
Patient almost immediately experience tachycardia (98-101), nausea, weakness, feeling of feverish Outcome: Called EMS, pt denied transport, husband will drive pt to the ER. Patient seen in ED and released. Given IV fluids and Zofran.
43 2021-04-22 burning sensation Fatigue, for 3 days. Swollen glands under left armpit and in left side of neck 5 days after vaccine ... Read more
Fatigue, for 3 days. Swollen glands under left armpit and in left side of neck 5 days after vaccine administration. Glands started to burn for about 36 hours. Burning went away and remained swollen. 15 days after left arm became sore around injection.
43 2021-04-22 difficulty speaking Weird taste in mouth after 5 minutes, within 15 minutes throat tightness, and back of tongue swellin... Read more
Weird taste in mouth after 5 minutes, within 15 minutes throat tightness, and back of tongue swelling. Some difficulty swallowing. Kept having to clear my throat. Hoarseness in my voice began soon after. Was treated with liquid benadryl 50mg po and used my albuterol inhaler. Vitals were taken by vaccination center clinicians and staff. Symptoms began to alleviate once po benadryl began working. Took a longer acting antihistamine, Allegra when I got home. Had to take another dose of Benadryl later this afternoon. Started itching all over body.
43 2021-04-22 flushing, tingling, numbness, hot flush About 10 minutes after receiving vaccine, pt reports chill/flush feeling in the neck/chest to groin... Read more
About 10 minutes after receiving vaccine, pt reports chill/flush feeling in the neck/chest to groin. Patient able to walk and skin flushed. Pulse at 60 and does have history of Arrhythmia. Shortly after breathing slows and appears to be hyperventilating. Blood pressure reading of 141/101 with pulse of 96. EMS is called. Few minutes later BP of 135/86 with pulse of 102. Before EMS arrives last BP of 122/93 with pulse of 101 with hands numb, white, and tingling. At 4;17 EMS arrives and pt walked to stretcher. At 7;45 PM, I called to check on pt. She reported another episode at ER but had been discharged and was currently in our parking lot retrieving car
43 2021-04-22 hot flush, burning sensation, feeling hot While waiting the required 15 minutes after receiving the Covid-19 vaccine, I felt a warm whooshing ... Read more
While waiting the required 15 minutes after receiving the Covid-19 vaccine, I felt a warm whooshing sensation start from my hips and go up my sides and down my arms. Then the under sides of my arms felt like they were burning. This occurred within 10 minutes of receiving the vaccine. The burning sensation lasted about 10 minutes. I did experience a few other smaller hot flashes during the next hour. No more after that point. The next morning I discovered a bruise at the injection site.
43 2021-04-22 pain in extremity, burning sensation Right arm pain radiated to subclavian area. Burning sensation. BP 140/85 (pulse 65), O2 sat 99%.
43 2021-04-22 pain in extremity Mild soreness of arm after shot. Sore throat starting on Wednesday the following week (6 days after ... Read more
Mild soreness of arm after shot. Sore throat starting on Wednesday the following week (6 days after injection) along with headache and swollen lymph nodes in neck/throat on Thursday night (7 days after injection). Still persisting on Friday morning and getting worse as I am typing this.
43 2021-04-23 feeling of body temperature change, tremor Starting around 1:00 am (almost exactly 12 hours following vaccination), patient experienced chills ... Read more
Starting around 1:00 am (almost exactly 12 hours following vaccination), patient experienced chills (alternating hot/cold sensations, sometimes hot/cold at the same time in different body parts), violent shaking/shivering, fever ranging from 99.9 to 102 degrees F (even after taking 400-600 mg of ibuprofen every 6 hours), body aches / pains in virtually all bones and muscles, and some organs (painful ear drums, eyelids, swallowing room temperature liquid felt painful in esophagus but no throat soreness); moving muscles to change position felt like bones would break and/or muscles / ligaments would tear; unable to find a singular comfortable position; unable to sleep; heart racing while in resting / reclined position - watch showed 15+ minutes of "fat burning" heart rate and "5 floors climbed", despite lying reclined and trying to sleep for more than 8 hours (having not walked more than about 1000 steps in the day to use the bathroom and drink fluids). The following day, fever broke, but patient woke sweating with a temperature of 96.6 degrees F (lower than the patient's average temp in the 97s-98.6 range). Body aches were mild to moderate, but mild nausea and diarrhea were experienced for all waking hours, and appetite was less than normal. Exhaustion still experienced in the third day (today 4/24), and body aches mild. No known fever at this time.
43 2021-04-23 muscle spasms experienced joint pain in my pinky of my left hand that was diagnosed as trigger finger; experienced... Read more
experienced joint pain in my pinky of my left hand that was diagnosed as trigger finger; experienced joint pain in my pinky of my left hand that was diagnosed as trigger finger; back spasm on my left side; This is a spontaneous report from a contactable other Health Professional (Patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 08Feb2021 16:30 (Lot Number: Unknown) and dose 1 via an unspecified route of administration on 11Jan2021 14:00 (Lot Number: Unknown), both as SINGLE DOSE (at the age of 43-years) in arm left for covid-19 immunization. Patient was not pregnant at the time of vaccination. Patient's medical history was not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date, the patient experienced joint pain in her pinky of her left hand that was diagnosed as trigger finger. It happened very suddenly and had it before. She also experienced a back spasm on her left side. She went to urgent care and they told her that they are seeing many people with spasming. Patient received an unspecified anti-inflammatory injection, and muscle relaxer as treatment for the event. Since the vaccination, the patient was not tested for COVID-19. Outcome of the event back spasm on my left side was unknown and for all other events, it was recovered with sequel on an unknown date.
43 2021-04-23 pain in extremity throat tightness; throat clearing; throat clearing difficulty swallowing; coughing with drink of wat... Read more
throat tightness; throat clearing; throat clearing difficulty swallowing; coughing with drink of water; unable to eat (beans and rice); generalized swelling at left arm; pain in left arm referring into back and neck; pain in left arm referring into back and neck; pain in left arm referring into back and neck; limited ROM; unable to lift arm; itchy ears; This is a spontaneous report from a contactable Other HCP (reported herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201 and expiry dates were not provided) via unspecified route of administration on 18Feb2021 17:45 as a single dose for COVID-19 immunisation. The patient was not pregnant. The patient's medical history was not reported. The patient was allergic to amoxicillin, azithromycin, doxycycline, sensitive to caines and walnut. Concomitant medications included ergocalciferol (VIT D) daily, vitamin b complex daily, melatonin as needed. Patient did not receive other vaccines within 4 weeks or prior vaccination. The patient did not have COVID 19 prior to vaccination and no COVID-19 test post vaccination. On 18Feb2021 17:45, the patient throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears. Therapeutic measures were taken with 50 mg Benadryl for throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), after 15-30 minutes later able to eat and no treatment received for rest of the events. The outcome of the events throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice) was recovered on an unspecified date on 2021 and generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears was not recovered.
43 2021-04-23 pain in extremity Tues 4/13/2021, pain started in my back and leg. By Sunday, I developed a rash on my back and was di... Read more
Tues 4/13/2021, pain started in my back and leg. By Sunday, I developed a rash on my back and was diagnosed with shingles.
43 2021-04-23 tremor severe chills, teeth chattering; shaking; sweating; swollen lymph nodes; severe intense pain; headac... Read more
severe chills, teeth chattering; shaking; sweating; swollen lymph nodes; severe intense pain; headache; fatigue; vomiting; nausea; This is a spontaneous report from a contactable other HCP (reported herself). A 43-year-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via unspecified route of administration in left arm on 16Feb2021 at 13:00 as single dose for COVID-19 immunisation. The patient was not pregnant. The patient medical history was not reported. There were no known allergies. The concomitant medication included Zoloft from an unknown date for unknown indication. There was no COVID prior vaccination. There were no other vaccines in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 25Jan2021 at 08:00. On 16Feb2021 at 23:00, the patient experienced severe chills, teeth chattering, shaking, sweating, swollen lymph nodes, severe intense pain, headache, fatigue, nausea and vomiting. Therapeutic measures were not received for the events. COVID was not tested post vaccination. The outcome of the events were recovering. Information on the lot/batch number has been requested.
43 2021-04-24 feeling hot felt like if I was going to pass out; whole body started feeling warm all over from my legs up to my... Read more
felt like if I was going to pass out; whole body started feeling warm all over from my legs up to my head; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration administered in the Left Arm on 25Mar2021 12:45 as a single dose for COVID-19 immunization. Medical history included gastritis. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 25Mar2021, within minutes after the vaccine, the patient's whole body started feeling warm all over from her legs up to her head and she felt like as if she was going to pass out. After 15 minutes it went away completely. No treatment was given in response to the events. The outcome of the events was recovered on 25Mar2021. The patient has not been tested for COVID-19 since vaccination. The reporter assessed the events as non-serious. Information about lot/batch number has been requested.
43 2021-04-24 feeling of insects crawling on skin Generalized itching, crawling sensation lower extremities, nose, neck, upper ext. No rash. Benadryl ... Read more
Generalized itching, crawling sensation lower extremities, nose, neck, upper ext. No rash. Benadryl 50mg and solumedrol given, symptoms relieved.
43 2021-04-24 hot flush Cold symptoms, heat flashes, feeling tired, sinus drainage, coughing,
43 2021-04-24 migraine Migraine, body aches, nausea.
43 2021-04-24 nerve pain Shingles. Went to clinic on 4/11 was diagnosed with shingles was put on medication. Medication is ov... Read more
Shingles. Went to clinic on 4/11 was diagnosed with shingles was put on medication. Medication is over, I still have shingles, the rash, nerve pain, itching.
43 2021-04-24 pain in extremity, numbness and pain in extremities, migraine Worsen neuropathic symptoms- pains on fingers, wrists, feet, toes, back.; migraine headache; Sore ar... Read more
Worsen neuropathic symptoms- pains on fingers, wrists, feet, toes, back.; migraine headache; Sore arm; fatigue; This is a spontaneous report received from a contactable consumer (patient herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration in left arm on 03Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included ovarian cancer, Blood clots, Hypertension and Sulfa: Allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA) 30 mg; warfarin 1mg and hydrochlorothiazide. On 03Mar2021, the patient experienced sore arm, Worsen neuropathic symptoms (existing side effects from chemo) - pains on fingers, wrists, feet, toes, back (medically significant), fatigue, migrain headache for 15 days after the first dose. No treatment received for AE. The outcome of events was not recovered. Information about lot/batch number has been requested.
43 2021-04-24 pain in extremity Sensation in the right lower leg b/w knee and ankle, a throbbing sharp pain/ sensation, constant she... Read more
Sensation in the right lower leg b/w knee and ankle, a throbbing sharp pain/ sensation, constant she is unable to walk and bear weight on leg w/o the sensation
43 2021-04-24 tingling, weakness, flushing Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: F... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: Benadryl 25mg given one dose bjd. temp checks done every 5 minutes. 30min overall event. Pt left with no issues with spouse. bjd
43 2021-04-24 tingling Tingling in hand and feet in left side of body . Tingling is intermittent.
43 2021-04-25 facial pain, facial paralysis, bell's palsy, involuntary muscle movements Started with right ear pain, which became within several days severe Bell?s palsy. I had complete r... Read more
Started with right ear pain, which became within several days severe Bell?s palsy. I had complete right sided facial paralysis, including the right side of my mouth, throat and eye not closing. I had extreme fatigue, facial pain, ear pain, throat pain, difficulty swallowing. This took 1 month to have improvement. Also had some elevated heart rate.
43 2021-04-25 feeling hot The 2nd and 3rd night after shot had very intense dreams and tossing and turning all night. Headach... Read more
The 2nd and 3rd night after shot had very intense dreams and tossing and turning all night. Headache on/off from date of shot 4/9 until 4/17, or 8 days after. BIGGEST event: 4th, 5th, 6th nights after shot (4/13, 4/14, 4/15), woke up 2 or 3am with elevated heart rate for myself (90bpm vs. 55-60 typical). Also very hot. Took an hour to calm down each night. Ended up in ER after 3 nights of elevated heart rate (4/15) to get checked out, but there was nothing found, and they said maybe it was a vaccine reaction, but may never know. Second dose is 5/3, so will see if have similar reactions....
43 2021-04-25 numbness, nerve pain Nerve pain and muscle pain was only in left arm at first but has continued to spread up to left shou... Read more
Nerve pain and muscle pain was only in left arm at first but has continued to spread up to left shoulder, left side of neck, and left ear/eye/side of head. It has not been one week since the vaccine and the muscle tension, nerve pain, and numbness has continued to increase and spread
43 2021-04-25 migraine I experienced body chills and a high fever about 10 hours after the shot. I took two ibuprofen for t... Read more
I experienced body chills and a high fever about 10 hours after the shot. I took two ibuprofen for those symptoms. Shortly after my fever broke, I began to experience severe and debilitating nausea. This lasted all through the night until about 6:00 am. I vomited stomach bile several times throughout the course of the night. I also had intermittent stomach cramps and had three bowel movements. After this subsided, I developed a migraine headache that lasted two days.
43 2021-04-25 tremor Within 1 minute of receiving the shot, I had the equivalent of an adrenaline reaction (rapid heart r... Read more
Within 1 minute of receiving the shot, I had the equivalent of an adrenaline reaction (rapid heart rate, shaking). This resolved within 5 minutes of sitting. No SOB or lightheadedness. No treatment necessary. (Never occured with a vaccine before.) The next morning, I had chest tightness over the left side of my chest that lasted for 3 days and resolved on its own. Following this, I had PVCs (which I don't normally have) for about 4-5 days, worse with activity (exercise, walking the dog, etc) and eating. This also resolved on its own. I informed my PCP office (the NP), but did not need to come in or postpone the second dose.
43 2021-04-26 pain in extremity Shoulder/arm pain
43 2021-04-26 pain in extremity Day after vaccine I experienced lower back pain and upper left leg pain. Two days after the vaccine... Read more
Day after vaccine I experienced lower back pain and upper left leg pain. Two days after the vaccine I observed a rash at the base of my spine, there were four dime sized red, raised hive looking spots. I also observed throughout the following hours a rash began to track from the base of my spine, down to my left buttock cheek, the side of my upper left thigh, and then the front of my upper left thigh. I went to Urgent Care and was diagnosed with Shingles.
43 2021-04-26 pain in extremity Started with an extremely sore arm at 10PM on the day of the 2nd dose, which was yesterday, April 26... Read more
Started with an extremely sore arm at 10PM on the day of the 2nd dose, which was yesterday, April 26, at 2:00 in the afternoon. Went to bed after taking OTC pain reliever and finally got out of bed because I couldn't sleep due to arm pain at 3:30 AM. About 4:30 AM I took my temperature to find a low fever of 100.7. That has been ranging from 100.7 to 99.4 all day today so far. At about 11AM I started to feel like I have the flu. My body aches all over, my joints hurt, I have a headache, and I am still unable to lift my left arm. I was completely fine with no symptoms yesterday when I went in to get the second dose of the vaccination. Today I feel like I got hit by a bus.
43 2021-04-26 tingling, burning sensation, electric shock sensation, pain in extremity At 8:00 pm after receiving the vaccine at 3:00 pm I started with chills. Went to bed to try to slee... Read more
At 8:00 pm after receiving the vaccine at 3:00 pm I started with chills. Went to bed to try to sleep and rest. Then this tingling feeling started. It would happen at different places through out my body. It would be in my arms, hands, chest, head, legs, feet, side or everywhere. Then it would be in just one area for a period of time. Next morning I started to get electrical shock feelings on top of the tingling. By Saturday I was in bed as my legs felt too weak to walk. The tingling was mostly just in my legs at this point. The electrical shock feeling was still coming and going but the tingling never stopped in my legs and feet. It would wake me up out of a dead sleep. This kept happening and I went to the doctor Monday morning. I had started to improve some. Still weak in my legs, tingling and some shock feelings. The doctor felt it was a nerve response to the vaccine and would pass after a few more days. It has improved as I am able to be up and doing things now. Unfortunately the tingling hasn?t stop at all in my right legs. Especially my last three toes and they hurt, burn and just feel odd most all the time. I still get shock feelings at times in that foot and some times other places but not as often. I still get tingling in the side of my head at times still also. Now today 4/27/21 my right hand is hurting and hard to move. My toes feel like they are curling under at times and they are perfectly straight. I still have a few nights where the shock feeling with wake me up in the night. Tomorrow will be two weeks from my vaccine. I wondered if this has happened to others, when does it stop, and should I get the second vaccine? I do not want to go back to the point where it was hard to walk even and the pain.
43 2021-04-26 tingling, numbness Numbness and tingling on half my face, tongue, ear, head and neck on the same side I got the shot. N... Read more
Numbness and tingling on half my face, tongue, ear, head and neck on the same side I got the shot. Numbness lasted about 6 hours.
43 2021-04-27 breast pain After first dose on 3/25/21, I experienced an intense headache within a few hours and sore arm at in... Read more
After first dose on 3/25/21, I experienced an intense headache within a few hours and sore arm at injection site, both subsided. I started my menstrual cycle two days later. Then 10 days later, I started spotting (very unusual for me) and had another menstrual cycle a few days after that. This resulted in two cycles within 21 days, which is also very unusual for me. After the second vaccination on 4/15/21, I experienced body aches and a fever within 12-36 hours from injection. I also experienced soreness in my right breast and lymph node above the breast (now 13 days post-vaccination and this has not subsided). I also had an episode of vertigo lasting 12 hours on the 10th day after the second vaccination.
43 2021-04-27 burning sensation, tingling On Friday 04/23 evening patient noted bumps on the right side of her head, (weren't itchy or painful... Read more
On Friday 04/23 evening patient noted bumps on the right side of her head, (weren't itchy or painful). Saturday started feeling R-sided ear pain,, and r-sided burning sensation of my head over my ear, so I thought I had an ear infection. (I do have seasonal allergies) Went to the Minute clinic on Sunday 04/25 to see if I had a ear infection, and was informed that I had some ear wax. During that visit I was diagnosed with hay fever and prescribed Zyrtec, and encourage to utilize Debroxs drops to clear out some ear wax. Zyrtec was taking right away on Sunday, and Debroxs was utilized also right away ono Sunday. Also during the Sunday visit the clinician assessed the bumps noted on my head and reported that it was noted to be red and irritated. Monday. Sharp pin and needles pain was noted on the right side of my head. Itching was also noted on Monday. Ear pain had subsided. On Tuesday I returned to the Minute clinic, able to get in sooner then my PCP. Assessment of the bumps were noted again, I did notice there were more, and at that point was diagnosed with Shingles
43 2021-04-27 feeling hot Patient complained of body heat. 1:10pm Patient refused to take B/P. Stated she is feeling better.... Read more
Patient complained of body heat. 1:10pm Patient refused to take B/P. Stated she is feeling better. EMS informed patient if symptoms return to call 911 or primary care doctor. (Patient is alertx3). Verbalized understanding.
43 2021-04-27 numbness My first vaccine was on a Tuesday. The following Saturday I woke up, around 8:15 am, and the right s... Read more
My first vaccine was on a Tuesday. The following Saturday I woke up, around 8:15 am, and the right side of my face was numb. My right eye kept tearing, nose was running, teeth and gums made it hard to eat. My face did not look droopy and my eyes were not crossed. I was scared and checked for other symptoms that could indicate stroke, eventually thought it could be the start of MS or something serious. Around 10 pm the numbness was gone. It has not returned but I am not sure if I should get the second dose. I called my pcp but office did not pick up so I just let it go, until I read that it could possibly be related to the vaccine (a few days ago).
43 2021-04-27 migraine Daily migraines for 6 days, treated with prescribed migraine med and ibprofren
43 2021-04-27 migraine Migraine; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female pati... Read more
Migraine; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm (reported as right and left arm) on 18Mar2021 a little after 07:00 (at the age of 43-years-old) (Batch/Lot Number: EN6208) as SINGLE DOSE for COVID-19 immunisation. Medical history included ongoing migraine since puberty, from around 13-14 years old, has been migraine free for five years; COVID-19 from Dec2020 to an unknown date. Concomitant medications included topiramate (TOPAMAX) taken for migraine from an unspecified start date and ongoing; butalbital, caffeine, paracetamol (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; rizatriptan benzoate (MAXALT) taken for headache, start and stop date were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. The patient experienced migraine on 18Mar2021 ever since she received the first dose of COVID-19 vaccine. The patient worked the night before she received her first dose of the Covid-19 vaccine, 17Mar2021 into 18Mar2021; she got the first dose of the Covid-19 vaccine the morning of 18Mar2021, came home, went to sleep, and woke up with a pounding headache around 1 PM on 18Mar2021. The patient considered the event medically significant as she had to get an MRI for it and the event required a physician office visit. The patient underwent lab tests and procedures which included magnetic resonance imaging: found white matter lesions consistent with chronic migraines which was normal for her on 07Apr2021. Therapeutic measures were taken as a result of the migraine which included migraine medications topiramate, Butalbital-APAP-Caff and rizatriptan which were not helping; physician changed her medications to a different rescue medication which did not help. The clinical outcome of the event migraine was not recovered (reported as low level of migraine for 4 weeks). The reporter considered the event migraine as related to the COVID-19 vaccine.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event and the suspect vaccine BNT162B2
43 2021-04-27 cold extremities, tingling, numbness Arterial clot in radial artery of left wrist, symptoms began on 1.05.21, 6 days after first vaccine ... Read more
Arterial clot in radial artery of left wrist, symptoms began on 1.05.21, 6 days after first vaccine dosage. Symptoms presented initially as numbness and tingling in the left thumb, index and middle fingers and progressed to being cold to the touch and purple in color. Numerous attempts at initial diagnosis were inconclusive until a hand CT scan was conducted on 1.15.21 with hospital admission later that day. Patient was transferred on 1.16.21 to Hospital to consult with a vascular surgeon. Clot was treated with heparin and warfarin, with 7 days in total for the hospital stay. Subsequent testing for clotting disorders found none.
43 2021-04-27 tenderness Next morning (4/27/2021) after receiving the shot (@ approx. 8:00 AM), tenderness was felt in the le... Read more
Next morning (4/27/2021) after receiving the shot (@ approx. 8:00 AM), tenderness was felt in the left armpit (same side shot was received). After examining armpit with fingertips, I felt what appears to be swollen lymph nodes.
43 2021-04-28 bell's palsy Systemic: Bell's Palsy-Severe
43 2021-04-28 facial pain Outbreak of shingles on the left side of my face and scalp involving pain around my temple, cheek, f... Read more
Outbreak of shingles on the left side of my face and scalp involving pain around my temple, cheek, forehead, and ears and a rash on my upper temple and scalp.
43 2021-04-28 feeling cold Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pu... Read more
Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pulse; extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Batch/Lot number was not reported), at the age of 43 years, as single dose for covid-19 immunization. Medical history included fibromyalgia and t5 back fracture. The patient is not pregnant. Concomitant medications included pregabalin (LYRICA); buspirone and cannabidiol (CBD OIL). On 16Apr2021 at 2 AM, the patient fainted 12 hours later and fell down to the ground after using restroom. She was cold, sweating, slowed heartbeat and pulse, extreme nausea. The patient did not receive treatment for the events. The patient had No COVID-19 prior to vaccination and had not been COVID-19 tested post vaccination. The outcome of the events fainted, fell down to the ground after using restroom, she was cold, sweating, slowed heartbeat and pulse, extreme nausea was unknown. Information about lot/batch number has been requested.
43 2021-04-28 numbness and pain in extremities, tingling I experienced - and am still experiencing - neuropathy in my feet and hands. It is worse on left sid... Read more
I experienced - and am still experiencing - neuropathy in my feet and hands. It is worse on left side, which is where my Pfizer vaccines were administered. I felt a light pins and needles/tingling after 1st dose of the vaccine. One week after the second dose of the vaccine, it became severe and persistent.
43 2021-04-28 pain in extremity The day after the vaccine I experienced brain fog, fatigue, and sore arm. I also got my period. I ha... Read more
The day after the vaccine I experienced brain fog, fatigue, and sore arm. I also got my period. I have a history of painful periods but after an endometrial ablation over 10 years ago I have had normal pain. The period after the vaccine was incredibly painful and the consistency of the discharge was completely different. Pale pink clots that almost looked like uterine lining instead of clots I'm used to seeing. I want to report this because I've talked to other women who've had something similar but I didn't see anything about it on the CDC website.
43 2021-04-28 tingling, difficulty speaking, speech disorder 7 minutes after receiving vaccine, I felt a rushing sensation in my chest and was extremely dizzy de... Read more
7 minutes after receiving vaccine, I felt a rushing sensation in my chest and was extremely dizzy despite sitting still in the chair. Both hands and fingers felt numb then tingly. As I was talking to the attendant, my voice suddenly became hoarse. It was somewhat difficult to talk and swallow sips of water. Blood pressures were elevated (150's/ 80's) when I am usually 90's/60's. Pulse oximetry readings were 99% on room air. Heart rate normal. I stayed at the vaccine clinic for an additional 25 minutes. The hoarseness and numbness and tingling subsided. No dizziness upon standing. I was told to contact my Primary Care MD for further instructions. The following 4 days I had a bright red, warm rash on my face (tops of the cheeks and across the nose) and intermittent hoarseness. I took tylenol per bottle instruction and two doses of benadryl 50mg. I updated my Primary Doctor.
43 2021-04-28 tingling almost passing out; Racing heart; tingling hands; dizziness; This is a spontaneous report from a con... Read more
almost passing out; Racing heart; tingling hands; dizziness; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 (Batch/Lot number was not reported) (age at vaccination: 43-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, and allergies: Penicillin. Concomitant medication included levothyroxine. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient was not pregnant. The patient experienced racing heart, tingling hands, almost passing out, dizziness. She was driving so she pulled over and called(#). Symptoms improved enough so that she did not request an ambulance. 10 minutes later she was home and became lightheaded again which has not resolved. It has been 1.5 hours since her dose. Adverse events started on 15Apr2021. No treatment received for the events. The outcome of events was recovering. Information on the lot/batch number has been requested.
43 2021-04-28 tingling Tingly feeling in face 45 min after shot and continued but lightened a bit around 4:15 pm and just l... Read more
Tingly feeling in face 45 min after shot and continued but lightened a bit around 4:15 pm and just lips and cheeks tingly Called an spoke with nurse at dr office and they said if not better in 24 hours to call back
43 2021-04-28 tingling After receiving the second vaccine, patient reported feeling "tingly" approximately 10 minutes after... Read more
After receiving the second vaccine, patient reported feeling "tingly" approximately 10 minutes after dose was administered. EMT team monitored for effects, could not find any signs of anaphylaxis or swelling. However, patient still reported not feeling well. Patient was given 25mg of diphenhydramine at 2:32pm that did not help with the symptoms. Pulse was 91, pulse oxygen was 98%. Blood pressure was not taken. After attempting to have the patient stand, they became very dizzy and were asked to sit back down. After monitoring for approximately 40 minutes with no improvement in symptoms, emergency personnel were called.
43 2021-04-28 cold extremities, tingling, burning sensation Tingling in arms and legs. Cold feet, burning in the arms and trunk of the body.
43 2021-04-28 tremor, weakness Within 5 minutes, I experienced light-headedness, dizziness, and a sense of confusion. This lasted f... Read more
Within 5 minutes, I experienced light-headedness, dizziness, and a sense of confusion. This lasted for about 20 minutes, then subsided. After that, I felt increasing fatigue. After 8 hours, I experienced extreme shaking and tremors throughout my whole body. This lasted for about 1 hour. I did not feel chills or hot or cold during this time. I felt extreme fatigue and weakness and was not able to get up from my bed to seek help. It was very scary. After 24 hours, I felt normal and healthy again.
43 2021-04-29 facial paralysis, numbness, pain in extremity, tingling, paralysis Complete paralysis of arms, hands and face for more than 1 hour. Tingling and some numbness in legs... Read more
Complete paralysis of arms, hands and face for more than 1 hour. Tingling and some numbness in legs and feet. Extreme pain in the arms. Rapid heart rate and sweating accompanied the paralysis.
43 2021-04-29 feeling cold, tingling Five minutes after injection, felt nauseated, face went cold and tingly, started rapid breathing, bl... Read more
Five minutes after injection, felt nauseated, face went cold and tingly, started rapid breathing, blood pressure elevated, felt very parched, hands tingly, thought I was going to pass out. This happened with the first Covid vaccine shot as well, so I lied down immediately after this shot, but it didn't help. I've never had this reaction to any other vaccine. Symptoms improved after 10-15 minutes, but I had to move very slowly. Felt very parched the rest of the evening and now as well (the next day). Had hallucinations of bright lights in my right peripheral vision that evening (which I've never had).
43 2021-04-29 muscle spasms 4 days after each vaccination, I experienced severe, painful bloating and cramping, diarrhea with b... Read more
4 days after each vaccination, I experienced severe, painful bloating and cramping, diarrhea with bloody stool and intestinal bleeding in conjunction with inflammation and stranding of descending colon
43 2021-04-29 tingling patient received first pfizer covid 19 vaccine and shortly following felt tingling from shoulders to... Read more
patient received first pfizer covid 19 vaccine and shortly following felt tingling from shoulders to finger tips that persisted along with arms, shoulder feeling heavy no resp distress or nausea / vomiting; staff checked vital signs, oximetry and blood sugar all of which were normal in serial fashion sugary beverage provided and gradual resolution of sx, not necessarily related to any or our intevention husband came and escorted to their vehicle if sx resolve as i suspect they will, she would remain a candidate for a second dose of vaccine
43 2021-04-29 tenderness I developed pain and tenderness in my forehead which progressed to blisters. It was diagnosed as Shi... Read more
I developed pain and tenderness in my forehead which progressed to blisters. It was diagnosed as Shingles by my doctor on 4/30/2021.
43 2021-04-30 breast pain, involuntary muscle movements App. Fifteen minutes after shot right arm feels heavy and numb. Stomach feels weak and tighten as i... Read more
App. Fifteen minutes after shot right arm feels heavy and numb. Stomach feels weak and tighten as if I'm about to have Diarrhea. During the course of the evening symptoms progress. Fatigue, increase SOB, feeling head expanding and heavy, throat tighten- constantly waking me up whiIe I grasp for breath, uncontrollable movement of the body, heavily congested. Symptoms continues - Saturday chest pain, both breast and severe body pain, lymph nodes swollen underarms and side of right breast. Feeling really horrible
43 2021-04-30 discomfort, hypersensitivity of all senses, burning sensation, pain in extremity, muscle spasms, numbness problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top... Read more
problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top of my head and my hands hurt; Nauseous; my hands and feet started going numb; they itch they burn; feet are painful; uncomfortable; blood clot/a clot or something in her legs; from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein; she thought she was having a stroke; cramps; burning from my calf to my feet; pain in her neck then to her back; pain in her neck then to her back; different temperatures like hot and cold make it bad and irritating; can't sleep well because of her symptoms; Swelling in her Feet; can't think right; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm in the morning of 01Apr2021 (Batch/Lot Number: ER8727) as a single dose for COVID-19 immunization. Medical history included ongoing complex regional pain syndrome, ongoing fibromyalgia, ongoing arthritis - all diagnosed 20 years ago. Her mother has lupus and rheumatoid arthritis and she can't have the vaccine, states she doesn't know if something could be genetic. Low potassium in the past and stated that she has a lot of allergies to medications, but she consulted with the pharmacist and he said it would be okay. There were no concomitant medications. No additional vaccine was administered on the same date of BNT162B2 and no prior vaccination within four weeks. The patient was having weird symptoms and she tried looking online and in different groups to find out if anyone has similar symptoms, but she hasn't been able to find anything. She began by saying she has health issues; she has Fibromyalgia and Complex Regional Pain Syndrome. She doesn't know if studies were performed on patients with those disorders that took the vaccine. It's been about 3 weeks since getting the vaccine (Apr2021) and she started having symptoms that she thought could be a blood clot. From the knees down, she was having a lot of pain, cramps, burning from her calf to her feet. She would keep rubbing them and massaging them. It was excruciating pain. She was having symptoms and she did go see her Nurse Practitioner on 14Apr2021 because she thought she was having a stroke or a clot or something in her legs or that she was having a problem with her cholesterol. The nurse thought maybe it was her electrolytes, because she had low potassium in the past, but everything came back normal. Her feet were painful but not as bad in Apr2021. She felt like her condition but it's flaring up like 200% it's like over a 10 on the pain scale. She can't think right, she can't work, and was very uncomfortable in Apr2021. The leg pain felt like it is really deep in the vein, it doesn't feel like it is superficial, and she can feel stuff or liquid flowing. Her pain alternates from her head to her neck to her feet and it is very uncomfortable. Her hands and feet started to go numb, not completely numb but like when they fall asleep from sitting on them and then hit something and it hurts. Her arms were burning like crazy; they itch, they burn in Apr2021. Different temperatures like hot and cold make it painful, bad and irritating, and she can't sleep well because of her symptoms. She doesn't know the exact dates, but it has been about a week, but it is changing. It started with cramps in her legs from her knees down. That is where she had injuries and she thought it was her cholesterol. From her knees down, she has cramps and pain and it is very uncomfortable, she felt a really deep pain. She has pain in her neck then to her back, it started in her lower extremities and it is going up. It has stayed the same and she has to keep taking Tylenol to control the pain. Her symptoms got worse and she started taking Tylenol and that helped and then on 15Apr2021, her hands and feet started going numb and she had a headache and pain on the top portion of her head (reported as brain) and her hands hurt, and she was nauseous. She hasn't heard back from the nurse practitioner, so she decided not to go and get it done because she felt it is from the vaccine. She also has swelling of feet in Apr2021, and now she just woke up an hour ago and she slept somewhat okay, but she had to take Tylenol. Now that she is standing, it felt like her legs are starting to hurt again. Treatment included Tylenol, which helps a little and she has to keep taking it. If she doesn't take Tylenol, she can't even function. The events from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein, cramps, my hands and feet started going numb, they itch they burn, feet are painful, uncomfortable, pain on the top of my head and my hands hurt/headache, swelling in her feet, nauseous, pain in her neck then to her back, different temperatures like hot and cold make it bad and irritating had not resolved, while the event can't sleep well because of her symptoms was resolving, and the outcome rest of the events was unknown.
43 2021-04-30 numbness, pain in extremity, tingling Within 15 minutes arm was sore, headache, within 3 hours extreme fatigue, headache, nausea, chills, ... Read more
Within 15 minutes arm was sore, headache, within 3 hours extreme fatigue, headache, nausea, chills, left ear pain, left pain in jaw area near left ear the gland on left side of neck lasted until 4/24/2021; 4/30/2021 Left arm soreness, swelling, muscle cramp in left arm, 5/01/2021 Arm soreness to touch at injection site, painful arm, tingling, numbness in left arm, headache, hands, thighs, back itching, chills, fatigue
43 2021-04-30 numbness Immediately after administration of 1st dose Pfizer, patient experience complaints of palpitations a... Read more
Immediately after administration of 1st dose Pfizer, patient experience complaints of palpitations and racing heart and "felt like a feeling of fear came over her." A&O x 4, reports Right foot numb but has also been seated in car waiting in line for > 1 hour. Patient given water and gummies and reports heart racing sensation improving. VITALS at 10:55 AM: HR 110 regular, Denies feeling of SOB, dizziness, itching, difficulty swallowing. At 11:13 AM, HR 88 and regular, BP 138/84, RR 20, O2 96% Patient reports sensation of tachycardia resolved and right foot numbness resolving. She was able to ambulate without distress.
43 2021-04-30 tingling, feeling cold, inability to speak When I got the shot I felt a cold sensation moving down my arm and an immediate shooting pain in my ... Read more
When I got the shot I felt a cold sensation moving down my arm and an immediate shooting pain in my elbow. I waited 15 mins and left the faculty. About 6 hours after receiving the first dose I started feeling weird. Light Nausea, similar to the feeling of being on a ship and feeling constant queasiness in the background. What came after was more concerning. I started feeling cloudy in my head and could not put my words together. I did, but it took effort. The top of my head started tingling. My chest started feeling tight (feeling similar to having a panic attack) so much so that I felt the need to roll down the window in my car and get air. When I came home I lay down and went to sleep early. The next day I felt better. My main symptoms were tingling on my head (where a baseball cap would cover the head) numbness in my tongue, tailbone pain, nausea, joint pain, and generally feeling cloudy. I am feeling better now but not completely back to normal.
43 2021-05-01 bell's palsy, facial paralysis Ear pain and facial drooping, vision loss presion in arm. Two visits to hospital emergency room diag... Read more
Ear pain and facial drooping, vision loss presion in arm. Two visits to hospital emergency room diagnosis as Bell's Palsy
43 2021-05-01 migraine Two days after the dose (on the 14th) my period began suddenly three days early, which is unheard of... Read more
Two days after the dose (on the 14th) my period began suddenly three days early, which is unheard of for me. I also developed a migraine on the 14th that lasted for a total of 9 days. This is also unheard of for me.
43 2021-05-01 migraine 24 Hour flu symptoms starting around 7pm on 4/23/21. Migraine started at the same time. Had it conti... Read more
24 Hour flu symptoms starting around 7pm on 4/23/21. Migraine started at the same time. Had it continuously till Thursday when the hospital gave me a stronger migraine medication with a Benadryl. I passed out at work due to the severe migraines and I was confused right before and after which I never had with migraines. They had to wake me up by rubbing their knuckles in my chest which I have a bruise now and brought me to the ER. The meds at the ER worked better for me since it was stronger.
43 2021-05-02 weakness I got the shot around 11am Thursday 4/29, worked the rest of the day (office job, at home) by evenin... Read more
I got the shot around 11am Thursday 4/29, worked the rest of the day (office job, at home) by evening I felt kind of run down and tired. Relaxed and watched tv in bed a lot of the evening. Slight headache, couldn't get to sleep but stayed in bed. Around 3am that night I decided to get up and get some ibuprofen from the kitchen. By the time I reached the kitchen, I felt woozy, like I had stood up too soon. Stopped for a moment till I felt steady and then continued to walk to the cabinet, I also was going to take a xanax to help me sleep (prior to this I had not taken a xanex for probably 4-6 weeks). I put the xanax in my mouth, grabbed the bottle of ibuprofen and felt like I should lay back down asap. Took a few steps and passed out and hit my head on small round table shelf. When I came to, I realized I had not even swallowed the xanex yet, it was still in my mouth. I'm guessing I wasn't out long but my husband didn't hear me fall so that is unclear. After I woke up and got back in bed, I realized my head was bleeding some from hitting the table. It appeared to be a small cut on the back of my head and I did not seek medical attention. I do intend to go to dr to get checked out for what I am guessing is a mild concussion, I have an appt for tomorrow. There seem to be 2 areas of impact on my head. I am assuming the back of my head hit the table shelf (near the floor), which was cracked from my head hitting it, and the other impact is to the right side of my head, which I assume is from the table leg. I think there is only a cut on the back of my head, and not the right side.
43 2021-05-02 burning sensation, nerve pain, numbness, pain in extremity Instant burning lungs for 12 hours with arm soreness, next day nerve pain in left leg (chronic back ... Read more
Instant burning lungs for 12 hours with arm soreness, next day nerve pain in left leg (chronic back and S/I issue, weak leg), then on Thursday, 48 hrs later, left underarm lymph node swelled, left neck swelled and left half facial numbness. Friday, I called Dr, they transferred me to hospital nurse who insisted I see the dr immediately. Dr did neuro exam and decided since I have blood clot history to send me to ER for a scan. At ER, dr was unsure of what to do or why I was there and sent me home. They just did a basic blood panel before I ever saw the dr. Burning lungs returned on sunday morning and facial numbness increased.
43 2021-05-02 muscle twitching On day 1 and day 2 (4/23-4/24) experienced headache and mild fatique. On day 5, (4/27) started notic... Read more
On day 1 and day 2 (4/23-4/24) experienced headache and mild fatique. On day 5, (4/27) started noticing involuntary twitching in legs, feet, arms, abdomen, shoulders, and back. This has been occuring daily since the onset.
43 2021-05-02 pain in extremity The day of receiving the vaccine I experienced severe chills and a fever the next day. I had an ongo... Read more
The day of receiving the vaccine I experienced severe chills and a fever the next day. I had an ongoing headache and my arm was hurting. What concerns me is I've had intermittent lightheadedness since receiving the 2nd vaccine on May 1st.
43 2021-05-03 burning sensation, facial pain Facial swelling, redness, burning/pain started 24 hours after injection and has not resolved itself ... Read more
Facial swelling, redness, burning/pain started 24 hours after injection and has not resolved itself 9 days later. Other common reactions (nausea, joint pain, chills, fatigue) started at the same time, and have since mostly resolved itself except I'm still experiencing fatigue and tiredness.
43 2021-05-03 flushing Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe
43 2021-05-03 numbness, pain in extremity Five days after second covid vaccine got bulging disk in her neck and shooting pains down right arm.... Read more
Five days after second covid vaccine got bulging disk in her neck and shooting pains down right arm. Has not resolved as of today still has pain and numbness in fingertips is seeing a chiropracter regularly and symptoms improve after chiropractor treatment.
43 2021-05-04 weakness, muscle spasms, numbness and pain in extremities, nerve pain Fatigue, exhaustion, heart palpitations, insomnia, weakness, muscle spasms, neuropathy in fingers an... Read more
Fatigue, exhaustion, heart palpitations, insomnia, weakness, muscle spasms, neuropathy in fingers and toes, feeling of body vibrating and nerve pain, and hair loss, lasting over a month. Also a much heavier than normal period that lasted 8 days (normal length is 4-5 days).
43 2021-05-04 weakness, pain in extremity fever (up to 101.5); extreme fatigue; sore arm; tightness/pressure in chest; lack of energy or will ... Read more
fever (up to 101.5); extreme fatigue; sore arm; tightness/pressure in chest; lack of energy or will to do anything
43 2021-05-04 weakness headache; loss of appetite; difficulty breathing, feels like a rock on top of her and and if she put... Read more
headache; loss of appetite; difficulty breathing, feels like a rock on top of her and and if she puts a mask on it is hard to breathe; dizziness; light sensitivity/ust had light sensitivity in her eyes; pain in her chest; bone pain; it hurts to open her eyes, her eyes started hurting; pain, soreness in her body, she had body aches, tiredness soreness; hurts when she talks and breathes; weak; Caller reported she had a fever of 100.4; tiredness soreness; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 at 11:30 at single dose in left arm for COVID-19 immunisation at the age of 43-year-old. Lot number was ER8733. Medical history and Concomitant medications were none. On 14Apr2021, the patient experienced fever 100.4, weakness, pain, soreness in her body, she had body aches, tiredness soreness. On unknown date, the patient experienced headache, loss of appetite, difficulty breathing, felt like a rock on top of her and if she put a mask on it is hard to breathe, hurt when she talked and breathed. On 15Apr2021, the patient experienced bone pain, it hurts to open her eyes, her eyes started hurting. On 16Apr2021, the patient experienced pain in her chest. On 17Apr2021, the patient experienced light sensitivity/ had light sensitivity in her eyes. On 18Apr2021, the patient experienced dizziness. On 14Apr2021, temperature resulted 100.4 and on 18Apr2021 was 100.2. The patient took Tylenol for fever; the patient was treated for light sensitivity/ had light sensitivity in her eyes. The patient did not recover form loss of appetite, light sensitivity/ had light sensitivity in her eyes; the patient was recovering from pain, soreness in her body, she had body aches, tiredness soreness; the outcome of other events was unknown.
43 2021-05-04 breast pain abdominal pain; vomited; acute appendicitis; appetite decreased steadily; increasing discomfort in m... Read more
abdominal pain; vomited; acute appendicitis; appetite decreased steadily; increasing discomfort in my abdomen; my left breast was experiencing significant stabbing pain around nipple area; This is a spontaneous report from a contactable consumer (reporting for herself). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 10:30 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. On 12Apr2021, immediately within 15 min. of injection, the patient's left breast had significant stabbing pain around nipple area. This lasted all day, until she went to bed at 9:30 PM. On 17Apr2021 throughout the week, her appetite decreased steadily and she had increasing discomfort in her abdomen. Saturday morning, she woke up at 5 AM in severe abdominal pain, she vomited, and was still horribly uncomfortable for hours. Finally, she went to the emergency room at 11 AM, where they performed a computerized tomography (CT) scan and told me she had acute appendicitis and required surgery to remove my appendix. The events resulted in emergency room / department or urgent care and hospitalization. The patient was hospitalized for 1 day and had emergency appendectomy. The patient underwent lab test and procedure which included nasal swab negative on 17Apr2021. The outcome of the event breast pain was recovered on 12Apr2021 at 21:30 while the outcome of the other events were recovering. The patient had no COVID prior to vaccination.
43 2021-05-04 breast pain Cold sore on lip. After 2nd shot. Sore right breast
43 2021-05-04 burning sensation Itchy palms and mouth started 1 hour post injection. Stomach pain/nausea/burning started 3 hours pos... Read more
Itchy palms and mouth started 1 hour post injection. Stomach pain/nausea/burning started 3 hours post injection. Still the same the day after.
43 2021-05-04 feeling jittery Fatigue, headache, dizzy and heart palpitations. Patient reports "everything feels jittery inside". ... Read more
Fatigue, headache, dizzy and heart palpitations. Patient reports "everything feels jittery inside". Referred to urgent care for further evaluation and tests.
43 2021-05-04 flushing, weakness, tingling, feeling cold, tremor Apx 08:31 pt c/o not feeling well, feeling flush, pale skin and feeling like fainting. Apx 08:37 sta... Read more
Apx 08:31 pt c/o not feeling well, feeling flush, pale skin and feeling like fainting. Apx 08:37 started c/o weakness, chest heaviness, dizziness and increased feeling to faint. 08:41 2L Oxygen started via nc, EKG completed-results unreliable due to poor quality resulting from pt stated having muscle tremors. stated having nausea. 911 activated. 08:53 pt c/o bilat hand tingling and coldness. 08:57 Fire on scene, paramedics transfer to ED. ED did chest X ray, ECG, Labs-CBC,CMP, Lipase,, Troponin, Pregnancy. Given normal saline and Ondansetron IV and Potassium Chloride PO. Discharged from ED 11:36
43 2021-05-04 hot flush Hot flashes that continue throughout the day, and at night. Started about week after taking the firs... Read more
Hot flashes that continue throughout the day, and at night. Started about week after taking the first dose of the vaccine. Followed by spells of tiredness that lasts from a few minutes to maybe 45 minutes and then goes away. Also, I missed my period, which was due around 4/22.
43 2021-05-04 hypersensitivity of all senses, burning sensation, tingling, numbness Right at injection I felt a mix of shooting and burning. I thought all shots must be this way so I ... Read more
Right at injection I felt a mix of shooting and burning. I thought all shots must be this way so I went into the waiting area for 15 minutes per instruction. I had no respiratory symptoms but realized that my arm, shoulder, left upper back, a little bit of the chest area in front near the shoulder, down my arm and into my fingers (mostly pinky ring and part of thumb) were either completely numb or pins and needles. My arm was getting heavy and tired and after 10 minutes many of the areas were completely numb. I told the nurse at the 10 minute mark and she checked for any respiratory distress which I had none. She told a few others and they decided it was probably just swelling around a nerve or something. They gave me ice and told me to give it a few days and pay attention if it goes up my neck or face. By the time I got home it felt like the left side of my face had pins and needles and a light numbness. Later that night my left ear was numb and my teeth started hurting and my lips felt like a dentist had done a numbing shot or something. This is day three and some parts are still numb and some have returned to pins and needles. Some places feel like they are...covered in cling wrap when people try to touch me. Today I have a ringing sound in my ears. I knew there was a chance for some side effects with these shots, but this seem really not ordinary. I reached out to a rep at the VAERS and he suggested I try to report to you all. I do not have health insurance so I am unable to get this checked out without accruing major bills. Has anything like this happened to other people? What do they do to fix it? Will it go away? Please advise.
43 2021-05-04 numbness Joint pain in all joints, most severe in my right wrist; numbness in feet; swelling in fingers and i... Read more
Joint pain in all joints, most severe in my right wrist; numbness in feet; swelling in fingers and in toes
43 2021-05-04 migraine Debilitating migraines; This is a spontaneous report from a contactable other HCP. A 44-year-old f... Read more
Debilitating migraines; This is a spontaneous report from a contactable other HCP. A 44-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 07Feb2021 12:00 (Batch/Lot Number: EN5318) as single dose at the age of 43-year-old for COVID-19 immunisation, administered at a facility. The patient medical history was none. No known allergies. The concomitant medications were not reported. The patient had not experienced Covid-19 prior vaccination. Patient was not pregnant. The female patient received bnt162b2 (BNT162B2), dose 1 on in arm left 17Jan2021 04:00 PM (Batch/Lot # EL8992) at the age of 43-year-old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced debilitating migraines on 28Mar2021. The event was considered serious as per disability or permanent damage. No treatment received for the event. COVID was tested post vaccination: Nasal Swab, PCR, resulted negative on 14Apr2021. The outcome of event was recovered with sequelae/lasting effects.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of migraine. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-05-04 numbness and pain in extremities, tingling, pain in extremity, numbness, burning sensation neuropathy; lower back pain that spread to her legs; lower back pain that spread to her legs/spread ... Read more
neuropathy; lower back pain that spread to her legs; lower back pain that spread to her legs/spread to her hands and it had spread to her feet; tingling; burning sensation and numbness mainly in her legs/back, hands, feet and in her shoulders this sensations come and go; burning sensation and numbness mainly in her legs; severe pain/sometimes spread to her shoulders; severe pain/It was her full body; This is a spontaneous report from a contactable consumer. This consumer reported for 43-year-old female patient (sister) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the arm on 10Mar2021 (lot: EN6205) at single dose for COVID-19 immunisation. Medical history included Juvenile rheumatoid arthritis, diagnosed 20 years ago (2001) and she was in remission. Previously she had a bilateral hip replacement but that was 20 years ago (2001), there had been nothing new since then. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 09Feb2021 (Lot Number: EC3247) for COVID-19 immunisation. On 12Mar2021, patient started experiencing adverse reaction, lower back pain that spread to her legs, mainly in the quarter area (deep leg pain). They have been to ER twice. She's also experiencing tingling, burning sensation and numbness mainly in her legs but also in her back, hands, feet and in her shoulders, this sensations come and go. Patient was in severe pain, it was at 9/10, and it was in her lower back and her quads area, it sometimes spread to her shoulders and hands and it had spread to her feet on both sides for all of these. It was her full body. It's been already three weeks after the vaccine and the doctors told her that this was caused by the vaccine and they're not sure how to treat her. In the emergency room the other day had given her codeine, which didn't work, and she didn't like the way she felt when she took that so she didn't take it anymore, and they had also given her morphine (it was an injection given at the hospital through an IV drip) and she was still in pain under the morphine, which didn't work. At first, they had prescribed patient hydrocodone and it didn't help her at all. She is now on one more new medication. Patient was on prednisone 60 mg, and she started this medication on 30Mar2021, and they wouldn't say it was helping her too much and that was a pretty big steroid dose. They gave patient prednisone 20 mg on 29Mar2021, and that didn't help at all and she ended up back in the emergency room so they hyped up her prednisone dosage to 60 mg on 30Mar2021 and was still taking this medication. Patient was using the lidocaine patches 5% (NDC: 0591352511, Lot Number: 1396641, and expiry: Jun2022), and reported that it was not helping with her specific issue and she was wanting to explain that, it is not that they didn't work, it was just not specifically helping patient for the current pain that she was having. Additional treatment included methylprednisone (NDC: 68382-916-34, Lot Number: M008443, Expiry: Jul2022): this was the original dose of the type of prednisone that patient was on. It was 4 mg per pill by mouth and that didn't work. It was in a manufacturer pack. Patient only took it one day because it wasn't helping and then when they went back to the emergency room they gave her the 10 mg per pill instead of the 4 mg per pill taper package. Tramadol: from 23Mar2021 and she was still taking this medication, at 50 mg, one tablet by mouth three times daily as needed. She was taking this for the same reason as above, to try and figure out what will reduce the pain. The providers wanted to see if this is muscular pain, or whatever it is, this is used to try and reduce it. Cyclobenzaprine: from15Mar2021 and she was still taking this medication, at 5 mg, one tablet by mouth three times daily for the pain. Gabapentin: On 15Mar2021 patient was originally taking 300 mg put then she was hiked up to taking 600 mg by the neurologist starting on 30Mar2021. She had been taking 600 mg three times a day by mouth since 30Mar2021 and she was still taking that dosage. Amitriptyline: from 15Mar2021 and she was still taking this medication, at 25 mg once a day by mouth. As of follow up information on 19Apr2021, the consumer reported that patient had formally been diagnosed with COVID vaccine induced neuropathy on unspecified date. Patient had been to the emergency room 4 times and hospitalized once. The patient went to the emergency room for the 4th time on 08Apr2021 and was admitted that night at midnight, hospitalized from 09Apr2021 to 12Apr2021. The patient is now on the medication as follows: Hydromorphone- 2mg tablets, one tablet every 4 hours as needed; Morphine extended release- 15 mg one tablet 3 times daily; Dexamethasone- 2mg tablets tapered down; Pregabalin- 300 mg 3 times daily; Cefradine (VELODYNE)- 10mg once daily. The patient's providers had been changing the patient's medication a lot. Now the patient is on hydromorphone hydrochloride (DILAUDID) and morphine and nothing is happening. The outcome of tingling, burning sensation and numbness was not recovered, outcome of other events was unknown.
43 2021-05-04 night sweats May 3 - exhausting, sweats/chills while sleeping; May 4 - exhaustion, full body ache (similar to bod... Read more
May 3 - exhausting, sweats/chills while sleeping; May 4 - exhaustion, full body ache (similar to body ache from flu), headache, and again sweats/chills while sleeping at night
43 2021-05-04 pain in extremity Started my period 2 weeks early; skipped a fertility cycle; headache; sore arm
43 2021-05-04 tingling, burning sensation "pins and needles" sensation, along with a burning sensation in her fingers and her toes; "pins and ... Read more
"pins and needles" sensation, along with a burning sensation in her fingers and her toes; "pins and needles" sensation, along with a burning sensation in her fingers and her toes; pain in joints; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8733) in left arm on 05Apr2021 16:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Apr2021, the patient experienced "pins and needles" sensation, along with a burning sensation in her fingers and her toes. Pain in joints. She reported that the symptoms were worse in her toes, and had been getting worse over the last week and a half, her regular doctor told her to not get the second dose. No treatment received for the adverse events. Patient did not diagnosed with COVID-19 prior to vaccination, patient had not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
43 2021-05-04 tremor Primary n cardiologist increased my metoprolol to 75 mg Nuero doc has put me on buspar to try to con... Read more
Primary n cardiologist increased my metoprolol to 75 mg Nuero doc has put me on buspar to try to control tremors using scopolamine patches help with dizziness
43 2021-05-05 hot flush, numbness, tingling My whole face got extremely hot. I felt my face get tingly. Right side of my face went almost numb. ... Read more
My whole face got extremely hot. I felt my face get tingly. Right side of my face went almost numb. Head felt tingly. Went away hours later.
43 2021-05-05 migraine Fever over 104 degrees for two consecutive days, migraines, nausea, pain in leg joints, constant chi... Read more
Fever over 104 degrees for two consecutive days, migraines, nausea, pain in leg joints, constant chills.
43 2021-05-05 nerve pain Pain in the buttocks and hip, nerve pain down the legs. Achy
43 2021-05-05 pain in extremity Day 2 : slightly sore arm. Days 3 - 7: everything was fine Days 8 - 12: injection site was red, sw... Read more
Day 2 : slightly sore arm. Days 3 - 7: everything was fine Days 8 - 12: injection site was red, swollen, and mottled/bruised looking (about the size of 3 quarter coins) and was SOOOOOO ITCHY Days 13 onward: things return to normal, but injection site is still slightly itchy
43 2021-05-06 weakness Lethargy and debilitating pain throughout my entire body. Starting at my head where my brain throbbe... Read more
Lethargy and debilitating pain throughout my entire body. Starting at my head where my brain throbbed like I was concussed, down my spine as though I had been in a car accident. The joints throughout my body throbbed with an arthritic type pain. I could not get out of bed was in a fetal position. It was also very painful when anyone touched my skin.
43 2021-05-07 migraine Shingles on the scalp with associated migraine headaches
43 2021-05-07 pain in extremity Sore arm, sore under arm, fatigue the day following the vaccination.
43 2021-05-07 pain in extremity Currently 4 days of bleeding; increased energy; sore left arm; overly emotional cry ie for a couple/... Read more
Currently 4 days of bleeding; increased energy; sore left arm; overly emotional cry ie for a couple/few days; menstruating when I had my period only 14 days before; This is a spontaneous report from contactable consumer, patient. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration, in the left arm on 09Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, and thyroid issues. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant drugs included ofatumumab (KESIMPTA) from 30Mar2020. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ocrelizumab and experienced hypersensitivity. On 21Apr2021 at 12:00, the patient experienced currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before. The outcome of the events, currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before was unknown.
43 2021-05-08 migraine Chills, muscle ache and fatigue, sharp abdominal pain, headache/migraine, shortness of breath, body ... Read more
Chills, muscle ache and fatigue, sharp abdominal pain, headache/migraine, shortness of breath, body aches, coughing, sore throat, dry throat
43 2021-05-08 muscle spasms Severe headaches, sweating, fevers, back/body aches, muscle cramps in thighs, small rash on left arm... Read more
Severe headaches, sweating, fevers, back/body aches, muscle cramps in thighs, small rash on left arm.
43 2021-05-09 pain in extremity I went to bed at 9:00 pm on May 7th feeling ok. Then at about 1:00 am I woke up and felt like I was... Read more
I went to bed at 9:00 pm on May 7th feeling ok. Then at about 1:00 am I woke up and felt like I was buzzing, I ached all over and I was wide awake and could not sleep for about 3 hours. I took some IBProfin and went to bed. I slept until 8:30 in the morning. At that time the buzzing had stopped and but I still felt achy all over. I was also tired. I felt like that all the rest of the day on May 8th. That night I went to bed around 9:00 pm and slept in until 7:00 am. This whole time my left arm where vaccine was given was sore when I lifted my arm. On May 9th I felt fine.
43 2021-05-09 seizure A week and two days after receiving the vaccine, I had a seizure while walking my dog. I was taken ... Read more
A week and two days after receiving the vaccine, I had a seizure while walking my dog. I was taken to the hospital and a Cat scan, MRI and EEG were all administered. No specific cause can be attributed to the cause of my seizure and the only factor that was different was that I was given the vaccine on 4/22/21.
43 2021-05-10 feeling hot Severe flu like symptoms; Fever of 101.4; Headache; Nauseousness; Aches; Fatigue; Red; Itchy; Hot to... Read more
Severe flu like symptoms; Fever of 101.4; Headache; Nauseousness; Aches; Fatigue; Red; Itchy; Hot to touch; Swollen at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 15Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID and was not tested for it prior vaccination. The patient previously received the first dose of BNT162B2 on 24Mar2021 02:00PM, on left arm, for COVID-19 immunization, and experienced only slight swollen arm. On 15Apr2021 20:00, the patient experienced severe flu like symptoms including fever of 101.4, headache, nauseousness, aches, fatigue for about 24 hours, red, itchy, hot to touch; then swollen at injection site. The patient did not receive treatment for the events. The outcome of the events was recovering. Information about lot/batch number has been requested.
43 2021-05-10 flushing Patient received vaccine and completed 15 minutes of observation. She returned back to us about 30 m... Read more
Patient received vaccine and completed 15 minutes of observation. She returned back to us about 30 mins after stating she was flushed, itching, and hives. We administered 50mg/1ml of Benadryl in the Right Deltoid. Patient observed for 30 mins and voiced relief. She was escorted home by co-worker.
43 2021-05-10 muscle twitching, feeling jittery Experiencing a buzzing feeling and twitchy in my feet and legs most noticeable when laying down. Als... Read more
Experiencing a buzzing feeling and twitchy in my feet and legs most noticeable when laying down. Also notice it now in my hands a bit. Some twitching in toes and fingers. Feel a bit jittery or trembly internally. Abdominal pain on and off throughout the last week. Slight dizziness at times.
43 2021-05-10 pain in extremity, tingling, nerve pain, numbness, burning sensation sore arm which dissipated over time. But then had severe nerve pain in her legs,; had severe nerve p... Read more
sore arm which dissipated over time. But then had severe nerve pain in her legs,; had severe nerve pain in her legs; having "fire and burning in the legs and feet"; inflammation to her eyes; the nerve pain is now pins and needles; numbness and tingling started happening in my face; lips with tingling and numbness, along with the left side of my tongue; lips with tingling and numbness, along with the left side of my tongue; I am also having trouble with vision; This is a spontaneous report from a contactable consumer. This 43-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8729, Expiry date: Jul2021) via an unspecified route of administration into the left arm on 03Apr2021 14:30 (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient medical history included endometriosis, allergy to medications like augmentin, Bactrim and flagyl. Concomitant medication included phentermine (37.5 mg, tablet). On an unspecified date, the patient reported that she experienced a sore arm (left side arm pain) which dissipated over time. But then had severe nerve pain in her legs. Her symptoms seemed more pronounced on her left side, had fire and burning in the legs and feet. She experienced inflammation in her eyes (had trouble with vision) stating she was not sure if this was really a bad case of allergies. Now her nerve pain was pins and needles but then numbness and tingling started happening in her face but that got better, lips with tingling and numbness, along with the left side of her tongue. She reported her second dose is due in a week and that she was unique and her symptoms were not listed as common but did not know if it was something that would prevent her from getting the second shot as she had side effect after the first dose of the vaccine. She asked if the symptoms she was having are being reported and if there would be a contraindication to getting the second shot and was referred to healthcare professional for guidance. The patient did not receive any other vaccines within four weeks prior to the Covid vaccine. No treatment was received for the adverse events. It was unknown if the patient was diagnosed with Covid-19 prior to vaccination. The patient had not been tested for Covid-19 since the vaccination. Outcome was unknown for all the events. Follow up #01(18Apr2021): This is a follow-up spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported for herself which included event details, lot number and expiry date. Follow up#02 (18Apr2021): This is a follow-up spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported for herself which included event seriousness, vaccine details, medical history and concomitant medication details. No Follow-up attempts are needed. No further information is expected.
43 2021-05-10 tingling Pt brought to med obs #1 via wheelchair with staff for c/o racing heartbeat and bilateral hand and l... Read more
Pt brought to med obs #1 via wheelchair with staff for c/o racing heartbeat and bilateral hand and lip tingling. Pt denies cardiovascular history. No SOB noted. Denies chest pain. No s/s of distress noted. Pt reported she felt better upon arrival to med obs. VSS. Pt discharged to home after evaluation by MD. Refused wheelchair. Escorted to exit with staff. Ambulatory independently. Gait steady. VS are as follows: 1045: BP 163/81, HR 101, RR 18, O2 sat 100% on RA 1050: BP 151/75, HR 91, RR 18, O2 sat 100% on RA
43 2021-05-11 discomfort Patient received the 1st COVID Pfizer vaccine, lot #EW0182 and use by date is 05/13/21 at 0930am. Co... Read more
Patient received the 1st COVID Pfizer vaccine, lot #EW0182 and use by date is 05/13/21 at 0930am. Co-Lead Vaccinator, RN, EMT, and EMT observer, responded to the patient who stated, " I have the sensation to clear my throat, almost as if there is this pressure in my throat," at 0925. The patient was sitting in the gravity chair and airway was patent, respiratory rate was regular and even with no signs of labored breathing. The patients vitals were taken at 0926 and were as follows: 118/74 ( right arm, sitting upright), 80 bpm, and RR of 15, and alert and oriented to person, time, place, and situation. Lead vaccinator, gave the patient diphenhydramine (Benadryl) 50mg, liquid suspension, PO at 0930. The client was placed in the supine position in the gravity chair. The patient denied difficulty breathing, shortness of breath, itching, dizziness, headaches, or nausea. The patient was talking in full sentences and was in no apparent distress. The patient stated, " The pressure in my throat is getting better, I just want to swallow is all." Vital signs were all within normal limits at 0935: 126/80 (right arm, sitting upright), 80 beats per minute, respiratory rate of 14 breaths per minute, 100% oxygen saturation. At 0940, the patient continued to state, " I just have the sensation to swallow." The patient was placed in fowler's position. The patient continued speaking in full sentences, oxygen saturation levels remained at 100%. The patient stated, " I prefer to be sitting upright," so the patient was then placed in a sitting upright position in the gravity chair. At 0951, the patient's vital signs were 126/80, 68 beats per minute, 100% oxygen saturation, and 14 respirations per minute. Patient was able to swallow without difficulty and no distress was observed. Patient verbalized hx of being afraid of needles and has no pertinent medical history. Patient denied having any chronic medical conditions and was on progesterone and estradiol for hormone replacement therapy. At 1000, patient's vital signs were 118/80 (right arm, sitting upright), 70 beats per minute, O2 sat of 100%, and RR of 15 breaths per minute. Patient was instructed about ER precautions. Gave patient V-Safe information, and reported occurrence in VAERS. Instructed patient to inform nurse of previous reaction to the first dose of Pfizer. Patient left site at 1002 with family member who provided transportation.
43 2021-05-11 pain in extremity On Sunday May 9th, I experienced a fever, chills, body ache, nausea, and headache from about 8am thr... Read more
On Sunday May 9th, I experienced a fever, chills, body ache, nausea, and headache from about 8am through 8pm. Then on Monday May 10th my left armpit (arm of both shots) was swollen and very painful. The pain has subsided a bit but is still uncomfortable today (5/12/2021). I read online it can take 4 weeks for swollen lymph nodes to fully recover.
43 2021-05-11 pain in extremity Sore throat with slight swelling sensation a minute after vaccination along with sore arm, dizziness... Read more
Sore throat with slight swelling sensation a minute after vaccination along with sore arm, dizziness, feeling unwell. Afterwards, myalgia, joint pain.
43 2021-05-12 difficulty speaking Patchy, red welts. Swollen tongue with tooth imprints on the sides. Voice changed to higher, more na... Read more
Patchy, red welts. Swollen tongue with tooth imprints on the sides. Voice changed to higher, more nasal pitch. Had some trouble breathing. Symptoms subsided after Benedryl.
43 2021-05-12 pain in extremity Tested positive For Covid on 19Apr2021; Nasal Swab tested positive for Covid on 19Apr2021; body ache... Read more
Tested positive For Covid on 19Apr2021; Nasal Swab tested positive for Covid on 19Apr2021; body aches; Sorearm; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 12:15 (Lot Number: EW0150) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hypothyroidism. The patient's concomitant medications were not reported. Relevant past drug history included Pennicilin and sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient first reported she received her first dose on 05Apr2021 and then got COVID on April 15th. She was due for her second vaccine on 26Apr2021 but due to isolation she was unable. She further reported that she had body aches and sore arm on 05Apr2021 for over a week. Nasal Swab tested positive for Covid on 19Apr2021 and was out of work for 10 days. The outcome of the events body aches and sorearm was resolving and for other events was unknown. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 on 30Apr2021.
43 2021-05-12 pain in extremity I got back pain, tiredness, thirst, and arm?s pain at the following day. Also, I got chills about 3... Read more
I got back pain, tiredness, thirst, and arm?s pain at the following day. Also, I got chills about 30 minutes 24 hours later. I got the same side effects with both doses, and they last in 24 hours.
43 2021-05-13 weakness appendix ruptured/aapendicitis; mild flu symptoms; energy level was low; stool is soft; bowel moveme... Read more
appendix ruptured/aapendicitis; mild flu symptoms; energy level was low; stool is soft; bowel movements are not consistent; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8737), via an unspecified route of administration, administered in the right arm on 29Mar2021 as a single dose for COVID-19 immunization. Medical history included allergy to penicillin from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE, reported as 'VYVANSE Xr'); duloxetine (manufacturer unknown) and lamotrigine (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021, the patient had stomach ache and pains. On 06Apr2021, the stomach pains were constant and sometimes sharp and there were mild flu symptoms. On 07Apr2021, the patient had severe stomach pain and flu symptoms. The patient took a nasal swab rapid COVID test also which came back negative. In the afternoon of 07Apr2021, the patient's temperature hit 104 and she went to the ER. After the CT scan, appendicitis was confirmed and the patient went into an emergency appendectomy. The patient's appendix ruptured. On 09Apr2021, the patient was released from the hospital. As of 28Apr2021, the most of the patient's symptoms are gone but bowel movements are not consistent and stool is soft. The patient's energy level was low and there was slight lower stomach pain at times. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
43 2021-05-14 feeling of body temperature change, migraine Fever 103.1, body aches, migraines, nausea, muscle psin, hot and freezing chills, pain at injection,... Read more
Fever 103.1, body aches, migraines, nausea, muscle psin, hot and freezing chills, pain at injection, hurts to swallow, and gum pain; Fever 103.1, body aches, migraines, nausea, muscle psin, hot and freezing chills, pain at injection, hurts to swallow, and gum pain; Fever 103.1, body aches, migraines, nausea, muscle psin, hot and freezing chills, pain at injection, hurts to swallow, and gum pain; Fever 103.1, body aches, migraines, nausea, muscle psin, hot and freezing chills, pain at injection, hurts to swallow, and gum pain; Fever 103.1, body aches, migraines, nausea, muscle psin, hot and freezing chills, pain at injection, hurts to swallow, and gum pain; Fever 103.1, body aches, migraines, nausea, muscle psin, hot and freezing chills, pain at injection, hurts to swallow, and gum pain; Fever 103.1, body aches, migraines, nausea, muscle psin, hot and freezing chills, pain at injection, hurts to swallow, and gum pain; Fever 103.1, body aches, migraines, nausea, muscle psin, hot and freezing chills, pain at injection, hurts to swallow, and gum pain; Fever 103.1, body aches, migraines, nausea, muscle psin, hot and freezing chills, pain at injection, hurts to swallow, and gum pain; exhaustion; sleeping constantly; hot one minute shivering the next; This is a spontaneous report from a Pfizer-sponsored Program. A Contactable female Pharmacist reported that: A 43-years-old female patient received bnt162b2 (BNT162B2;PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 as SINGLE DOSE for covid-19 immunisation.The patient medical history was not reported. Concomitant medications included rabies vaccine (RABIES) taken for an unspecified indication from 21Mar2021 to an unspecified stop date.The patient experienced fever 103.1, body aches, migraines, nausea, muscle psin, hot and freezing chills, pain at injection, hurts to swallow, and gum pain,sleeping constantly ,hot one minute shivering the next on 14Apr2021 17:30 The patient underwent lab tests and procedures which included pyrexia: 103.1 on 14Apr2021.Question: Warm transfer from Pfizer, CEP 2191. Caller is a pharmacist, asking if it is ok to get the second dose of the covid vaccine with a recent sore throat that may or may not be strep? Caller reports that she has a sore throat, she has not been tested for strep but is due to get her second vaccine dose and is asking for additional guidance.During this call the caller also reported that after receiving her first vaccine dose she experienced body aches and fever but did not report it because it was consistent with the common side effects. Caller did not report symptoms because they were consistent with the listed common side effects. Remembered AE after call end.Information on the Batch/Lot number has been requested.To add a new event bone pain" per verbatim "Fever (38°C), asthenia, pain in the bones, pain in the mouth, and worsening of dysgeusia started (and never finished) in Apr2020 as a result of the Covid19 infection".Add an event "condition aggravated" for dysgeusia. Event onset date outcome seriousness go with "dysgeusia".Add "dysgeusia" as medical history with start time "Apr2020" and with note "as a result of the Covid19 infection The events were assessed as No serious by health authority outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained
43 2021-05-14 tingling Within 2-3 minutes of receiving shot, I felt "not present" and detached from my body. "Unreal" feeli... Read more
Within 2-3 minutes of receiving shot, I felt "not present" and detached from my body. "Unreal" feeling, worse than recovering from nitrous oxide and Novocain after dental surgery. Five minutes after shot, the left side of my face became tingly and swollen - from my chin, lips, eye socket, up to my scalp. Tingle and numbness spread to entire back of my head and down the whole left side of my body. This sensation lasted approximately 30 minutes. At 15 minutes, I was checked by a paramedic for hives, tongue swelling and my oxygen level (oximeter). They did not administer any medicine to counteract. They observed me for another 15 minutes and sent me home with instructions to take Benadryl and a nap. Unable to drive myself home. I slept for 3 hours. Was lethargic and exhausted.
43 2021-05-14 throat numbness, facial paralysis, numbness 5 mins after inject, dizziness 0954: Severe left ear pain, that minimized and I developed bilateral... Read more
5 mins after inject, dizziness 0954: Severe left ear pain, that minimized and I developed bilateral cheek/mouth numbness 1004: Numbness developed in my mouth, tongue and throat 1030: Sitting up right and with feeling of left sided drift 1230: Numbness going down my chin and throat 1530: Drinking water, coughing up water, severe throat pain, numbness all over face, RUE, and going down chest. Took a dose of PO Zyrtec OTC 1600: Spouse and son noticed right sided face mouth drooping, right side of lip not moving. RLE felt like weight on my leg 1715: Went to ER, rec'd 1L of NS, IV Benadryl, IV Solu-Medrol, IV Pepcid 2300: Noticed my face was symmetrical and RLE heaviness gone 5/14: Continued with numbness around mouth. No RUE, Throat or RLE pain 05/15: 1050: Feeling better, mild HA. on PO Prednisone taper
43 2021-05-16 flushing Syncope, Flushing/sweating. Post vaccination pt had a vaso vagal/syncopal episode in her seat in obs... Read more
Syncope, Flushing/sweating. Post vaccination pt had a vaso vagal/syncopal episode in her seat in observation. Pt did not fall. Pt was wheeled back in supine position. VS stable. Patient recovered, drank juice. When stable, patient was released from the vaccination site.
43 2021-05-16 hot flush, feeling hot I received the vaccine and as soon as she was done giving the vaccine I had an overwhelming warm fee... Read more
I received the vaccine and as soon as she was done giving the vaccine I had an overwhelming warm feeling all over. And since 10 min after receiving this vaccine I've had hot flashes every 10-15 minutes for the last 10 days with no signs of it stopping or slowing down. I have never experienced hot flashes before the vaccine and I am not in menopause yet. The vaccine has also made me feel extremely irritatable since that day. I almost feel like this vaccine kick started menopause in me or something. I regret ever getting this vaccine! I blame all this on the vaccine since I never had any of these symptoms before receiving the vaccine.
43 2021-05-16 pain in extremity, burning sensation She got her vaccine, arm was sore immediately until 6:00 PM when she started getting severe menstrua... Read more
She got her vaccine, arm was sore immediately until 6:00 PM when she started getting severe menstrual cramps, but not due for her period. She thought it was weird and her ribs were burning. She went to sleep and about 24 hours the menstrual cramps went away, but the pain in the right side remained. By Friday the pain was wrapping around to her back, and by Saturday she felt that there was a long thin balloon pressure going from her right side of her ribs and wrapping around to her back. It was burning type of ache. By Saturday she had told some family members, and told her that it sounded like appendicitis and she just watched it. Today it is a little more fainter, it is a little bit lighter. She did the patient portal this morning and she lives next to the hospital and said if it got worse she would go to the hospital. She is waiting to hear back from her doctor to see what she should do. She has not taken anything for the symptoms.
43 2021-05-16 tingling Received the Pfizer 2nd dose on 9th April. Following day (04/10), I had body ache, fatigue, mild tem... Read more
Received the Pfizer 2nd dose on 9th April. Following day (04/10), I had body ache, fatigue, mild temperature 99.8, back neck and upper arm/shoulder pain. While I recovered from the ache and fatigue the next day (04/11), the neck pain continued for a couple of weeks. On 23rd April, the pain aggravated and I took a 2 Advil's (2 tablets of 200mg each) which made the overall pain extremely critical. The pain was mainly in the neck, upper arm, tingling in the fingers, grinding jaw pain, all symptomatic to a cardiac pain. I visited the Urgent care and they suggested I rush to Emergency care. See the notes attached. I was detected with Myocardial infraction or Heart Inflammation (as there was an increasing Troponin). They did an Angiogram to detect any blockages but was cleared of all blockages or major heart conditions. Was hospitalized for 2 days and was on observation for any new pains, repeat or increase in symptoms. Heart inflammation continues to be there and I am unable to take any anti inflammatory as that aggravates the cardiac/ MI pain. No prior history of heart disease etc. Will be visiting for repeat tests with the Cardiologist in coming weeks. Since there were no prior heart condition and since this initiated day after the 2nd vaccine, i strongly believe this is a side effect from the vaccine dose.
43 2021-05-17 nerve pain After couple of hours, the nerve on right cheek started paining. By morning, I was having pains all ... Read more
After couple of hours, the nerve on right cheek started paining. By morning, I was having pains all over the body and the nerves were swollen, looking bluish green. I took rest and Tylenol. After sometime, the pain went down. I took Tylenol for 4 days. My heart rate when resting was so high that I feared it could be wrong. On advice of a medical friend, took day off from work and rested. In two days, I got back to normal
43 2021-05-17 pain in extremity, muscle spasms, burning sensation Since the vaccine my right arm has been in a lot of pain. At first it was quite sharp and then it ha... Read more
Since the vaccine my right arm has been in a lot of pain. At first it was quite sharp and then it has become more of a throbbing pain. At first it was localized to the site of the injection and as time has passed it is all up and down my arm but not above the injection site. It is still painful and often there is a burning sensation or a feeling of twisting in different sections. I think it is nerve damage but have not gone to the doctor yet. It has been hurting for almost two months now.
43 2021-05-18 weakness I am still very fatigued, no appetite, weakness, and stomach ache; Very fatigued, muscles in legs ac... Read more
I am still very fatigued, no appetite, weakness, and stomach ache; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving.; This is a spontaneous report from a non-contactable health professional. A 43-year-old non pregnant female patient received second dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration in Arm Left on 21Jan2021 as single dose for covid-19 immunisation. Facility where COVID-19 vaccine was administered was hospital. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included clonazepam. Known allergies is none. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (BNT162B2, solution for injection), on 21Jan2021 in the left arm at single dose for COVID-19 immunisation. On 22Jan2021 the patient experienced Very fatigued, muscles in legs ache, nausea, no appetite, headache, weakness, soreness where the injection was, lower back pain to the point of being in tears with any moving. The patient stated that I am still very fatigued, no appetite, weakness, and stomach ache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Dec2020. Outcome of the events were not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
43 2021-05-18 weakness shingles, weakness, and tiredness.
43 2021-05-18 discomfort, pain in extremity This is a spontaneous report from a non-contactable 43-year-old female Nurse (patient, self-reported... Read more
This is a spontaneous report from a non-contactable 43-year-old female Nurse (patient, self-reported). A 43-year-old non-pregnant female received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; reason was misplaced/discarded and Expiration Date: unknown), unspecified dose via an unspecified route of administration in left arm, on 03Feb2021 13:30 (age at the time of vaccination was 43 years) as single for COVID-19 immunization in the hospital. The patient's medical history and concomitant medications were not reported. The patient did not receive other medications within 2 weeks of vaccination. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 03Feb2021 at 19:00, the patient experienced fatigue, sense of heaviness and sluggishness, headache, and dull throbbing pain in right lower anterior leg unrelieved by massage or rest. No treatment medications were reported. The reported assessed events as non-serious. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
43 2021-05-18 flushing About 5 to 10 minutes after receiving her first dose of the Pfizer covid vaccine, the patient report... Read more
About 5 to 10 minutes after receiving her first dose of the Pfizer covid vaccine, the patient reported slight difficulty breathing, throat/tongue swelling and a flush face. She said that she felt the same as when she eats peppers, which is a known allergy to her. We administered an epipen and called 911. Medics arrived in about 10 minutes and took the patient off in the ambulance.
43 2021-05-18 muscle twitching, tingling, numbness and pain in extremities, numbness, flushing, burning sensation A few minutes after my first injection shot, I experienced a wave of nausea, flushing, and a metalli... Read more
A few minutes after my first injection shot, I experienced a wave of nausea, flushing, and a metallic taste. I waited for 30 minutes and was assured everything was stable. During the next several days, I experienced high fevers, nausea, vomiting, myalgia, and minor neuropathy (legs/feet). Over the next few weeks, I continued to have intermittent fevers, nausea, myalgia, and episodes of numbness and tingling in my hands and feet. I consulted with my PCP on 1/28 to see if I should continue with the 2nd dose and was advised to do so. After receiving the second dose, I experienced a similar reaction as the first, with high fevers, nausea, vomiting, myalgia, and minor neuropathy in my legs and feet. One new symptoms following the second dose was muscle twitching in the legs. Approximately two weeks after the second dose, I experienced acute paresthesia of both legs. It began with a bubbling sensation for two days and then progressed to an abrupt onset of burning and tingling. The muscle twitching in both legs increased and also began to appear in my arms. It is now 3 months past the second dose and I continue to have all over muscle twitching and chronic paresthesias of both legs, arms, hands, and tongue (worse in legs). I also have extreme pain in all of my fingertips, intermittent electric shock sensations in my face and mouth, and internal vibration/buzzing sensations. My POTS symptoms which I had previously managed with adequate hydration and TriOral rehydration salts (no medication) have all been exacerbated. On a side note, I also experienced two menstrual cycles in both months that I received the vaccine and continue to have spotting between periods. I do not have a history of irregular menstrual cycles or spotting. I am currently scheduled for an ultrasound and endometrial biopsy to further assess these symptoms.
43 2021-05-18 pain in extremity Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection si... Read more
Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Swollen, sore spot in armpit; Swollen, sore spot in armpit; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EL1283), via an unspecified route of administration on left arm on 26Jan2021 08:00 as single dose for COVID-19 Immunization. Medical history included ongoing high blood pressure, ongoing prediabetes and allergic to sulfa. Concomitant medications included ethinylestradiol/norgestimate (TRI-SPRINTEC 28), losartan, metformin, vitamin D3 daily, ascorbic acid (VITAMIN C) daily and calcium, magnesium. The patient previously took lisinopril and experienced allergy. The patient historical vaccine included first dose of BNT162B2 (Lot number: EK5730) on 06Jan2021 (at 43-year-old) on right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, the patient experienced red, swollen, sore/tender, itchy on injection site and swollen, sore spot in armpit. The Patient did not receive any treatment for the events. The events were assessed as non-serious by the reporter. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was reported as recovering. Follow-up attempts completed. No further information expected.
43 2021-05-18 pain in extremity On 5/18/21 I woke up at 0300 with severe pain in right arm. Took Ibuprofen and went back to bed. ... Read more
On 5/18/21 I woke up at 0300 with severe pain in right arm. Took Ibuprofen and went back to bed. Woke up around 0800 and had pain under my arm. Saw that my lymph node is severely swollen and sticking out of my arm pit. Its about the size of a baseball now on Day 3. It progressively got bigger throughout day 2
43 2021-05-18 tingling 6 hours after the vaccine I developed a very strong headache, specially behind my left eye and left ... Read more
6 hours after the vaccine I developed a very strong headache, specially behind my left eye and left side of my head. I felt a lot of pressure at the back of my head and neck. After 24hrs the pain was just a discomfort. Three days later The same headache and neck pressure came back with addition of rashes near my left eye . Discomfort in my left nostril and left eye muscles. Last nigh, my left eye lid started getting swollen and it is swollen still. The rashes are very itchy and feel like pin needles poking them. I believe these reaction are related to the vaccine due to the same headache and pressure I felt after both doses, with the exception of the rashes
43 2021-05-19 fibromyalgia Patient has fibromyalgia and experienced a flare after having the vaccine. She ended up in the ED an... Read more
Patient has fibromyalgia and experienced a flare after having the vaccine. She ended up in the ED and rates her pain at 10/10.
43 2021-05-19 tingling Started with the right arm turning purple or changing colors when elevated above the head. This co... Read more
Started with the right arm turning purple or changing colors when elevated above the head. This continued for a few weeks. Then I started to get a tingling sensation in the elbow that went into the right pinky. I visited my primary doctor to see what was going on. She did an evaluation, prescribed Ibuprofen and physical therapy, and had a cervical spine x-ray done. The X-ray looked great when it came back. I could not get an appointment with PT for several weeks so I finally went to the chiropractor on 5/13. He worked on the shoulder area stretching it out. By the morning of 5/15 I was being taken to urgent care and eventually the ER because the arm was swelling and fingers were turning blue. They did blood tests, EKG, chest x-ray, and finally an ultrasound that showed a blood clot. It was DVT in the subclavian vein. I was given a blood thinner and sent home. I had a more thorough ultrasound on 5/17 that sent me back to the ER and with vascular surgeons to discuss immediate surgery with lysis therapy. It was decided that the blood clot had probably been there for weeks and the success rate of the surgery would not be as good.
43 2021-05-20 difficulty speaking Patient reported experiencing chest tightness and coughing. she experienced pruritus to the chest ... Read more
Patient reported experiencing chest tightness and coughing. she experienced pruritus to the chest that quickly subsided. she also reported a hoarse voice and was slightly shortness of breath. she was also light headed for few seconds. she denies throat tightness , difficulty breathing and any other cutaneous symptoms. her symptoms subsided after approximately 10 minutes. she was instructed to wait full 30 minutesand the is free to leave if symptoms resolved
43 2021-05-20 pain in extremity Sore arm initially. Started to feel all around muscle ache and fatigue during the day after I receiv... Read more
Sore arm initially. Started to feel all around muscle ache and fatigue during the day after I received the shot. I went to bed early and woke up with hives. Taking over the counter allergy medicine.
43 2021-05-20 tingling Pt informed recovery nurse that she was feeling dizzy and had tingling to her left arm distal to vac... Read more
Pt informed recovery nurse that she was feeling dizzy and had tingling to her left arm distal to vaccine injection site. Pt is a/o x4 with normal speech, equal facial symmetry, and equal grip strength. Pt is not c/o any itching, SOB, or orofacial swelling. Pt was placed in position of comfort with feet elevated, given a bottle of water, and monitored in post-vaccination area. Pt was hypertensive and stated that she did not know her normal blood pressure. Pt was monitored until 0935 when she stated that she was no longer dizzy. Pt was advised to seek immediate medical care should her symptoms return or worsen; Pt verbalized understanding. Pt left facility without further incident.
43 2021-05-21 burning sensation Missed menstrual cycle. Severe burning joint pain
43 2021-05-21 facial pain Severe pain from inner right ear to right cheek from morning continued without stopping
43 2021-05-21 tremor, pain in extremity Immediately - dizziness, heart racing, difficulty breathing, lightheadedness, pain in arm, slight tr... Read more
Immediately - dizziness, heart racing, difficulty breathing, lightheadedness, pain in arm, slight trembling, moderate chest pain. 20 minutes afterward - confusion, delusions, trembling, chills, uncontrolled teeth chattering, tensed muscles, uneven gait, arm pain slowed body mechanics. Persistent day of to 3 days after - low grade fever 101.3F, chills, excessive thirst, stiff joints, loss of range of mobility in finger movements, enduring arm pain, exhaustion, fatigue, muscle aches, photophobia, headaches, swollen glands, red mark on arm lasted for days. Longer range changes - persistent chills and fatigue. Menstrual cycle disrupted. Menstrual-like bleeding but 2 weeks early. Still bleeding.
43 2021-05-23 nerve pain Plantar fasciitis had just about resolved and then after shot #2, symptoms became much, much worse w... Read more
Plantar fasciitis had just about resolved and then after shot #2, symptoms became much, much worse with nerve pain, increased pain, longer lasting pain. This started the night of my second shot. Second shot was on 4/22/2021 (first shot 4/1). As of 5/24 it still has not resolved despite multiple different types of treatment. It has not even gotten back to the point it was just before shot #2 (I was still feeling symptoms but it wasn't too bad).
43 2021-05-23 pain in extremity On the 22nd, my left arm was sore after the shot - akin to a flu shot. Yesterday, the 23rd, the pain... Read more
On the 22nd, my left arm was sore after the shot - akin to a flu shot. Yesterday, the 23rd, the pain in my left arm increased. For about six hours, on the 23rd, I had a shooting pain from my left armpit down arm to tips of 4th and 5th fingers. When I awoke this morning, the intense shooting arm pain was gone, although I cried out in pain when my daughter touched the site of my shot. Around 9am, I experienced intense fatigue and slept intermittently until noon, about 2.5 hours. Around 3:30pm I experienced very loose bowel movements, on two occasions. After each of the two loose bowel movements, I took immodium.
43 2021-05-24 numbness 2nd dose: Around 6pm of the same day of the shot, I started feeling nauseous, throwing up, body ache... Read more
2nd dose: Around 6pm of the same day of the shot, I started feeling nauseous, throwing up, body aches, severe headache, fever. The next morning around 6am, I was bleeding out of my nose and butt, feeling worse than the night before. Monday evening, 5/10/21, I started having pain on the left side of my neck and chest pains and my left arm was going numb and was rushed to the ER. An EKG was done and I was checked by the Dr, which he said my neck was swollen and my arm was most likely numb from a pinch nerve. The EKG showed normal. Was sent home to rest and take Tylenol. I continued to feel sick the rest of the week. I noticed my lower part of my legs were then turning purple, which by the end of the following week has spread up to my thighs. It looks like honeycomb under my skin from my butt to my thighs dow n to my legs and my arms are faintly purple. The temperature does not make a difference.
43 2021-05-24 tremor, flushing I had heart papatations, feeling really flused, shaking, and dizzyness
43 2021-05-25 weakness Weakness; Fever; Body aches; Cold Chills; This is a spontaneous report received from a contactable h... Read more
Weakness; Fever; Body aches; Cold Chills; This is a spontaneous report received from a contactable health care professional. A 43-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EN6206) intramuscularly in right arm on 07Mar2021 at 12:45 PM (at the age of 43-years) as a single dose for COVID-19 immunization. Patient received her first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EJ1686) intramuscularly in right arm on 06Jan2021 at 02:30 PM for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not have any medical and known allergic history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since having the vaccine. Patient did not take any other medications within 2 weeks of vaccination. No concomitant drugs were reported. The patient experienced cold chills, body aches, fever and weakness on 14Mar2021 at 09:00 PM. The patient received fever reducers as a treatment for fever. It was not reported if the patient received any treatment for other events. At the time of this report, the patient was recovering from the event cold chills, body aches, fever and weakness. No follow-up attempts are needed. No further information is expected.
43 2021-05-25 burning sensation 7 days after vaccine, "face episodes" erupt; "face episodes" = 7-10 days of eyelids swelling; upper ... Read more
7 days after vaccine, "face episodes" erupt; "face episodes" = 7-10 days of eyelids swelling; upper and lower lids; entire face is burning; tiny red bumps / burning rash on face; THIS ONLY OCCURS ON MY FACE AND EYELIDS. "episode" each episode follows same phases = begins with itching of eyes, skin and eyelids weep or seem to be shiny and oily; then affected areas start to harden and dry over, face feels like alligator skin on top of it; then, affected area chaffs or peels off and reveals somewhat new skin; looks like had a chemical face peel. I have had FOUR major episodes since first Pfizer shot on 04/08/21; affected a total of 30 days on and off, so far. Latest episode ended 05/25/21. *Have pictures!
43 2021-05-25 numbness, burning sensation, tingling Pfizer Vaccine Round 1 03/24/2021 8 days later severely swollen Lymph-nodes on left armpit with ma... Read more
Pfizer Vaccine Round 1 03/24/2021 8 days later severely swollen Lymph-nodes on left armpit with major back pain (Area where current lesion is at T5) PT care stated is was a new side effect from the vaccine. It took almost 3 weeks to get a little better. Pfizer Vaccine Round 2 04/14/2021 (LOT EW0162) Immediate relapsed in Lymph-node swelling and back pain again in same T5 area. 05/06/2021 Visited care facility as I felt numbness and tingling in stomach and all right leg from stomach to toes. Fully mobile and able to walk. Suggested I see a neurologist. 05/15/2021 Checked in to ER *Tingling, burning, pain, and light tingle in left side of face. *All test were done at this point. -MRI of brain and spine -Blood work -Spinal tap -Started IV Steroid infusions (total of 5 - last one given 05/19/2021) **** Diagnosed with MS (Multiple Sclerosis) ***** I never had any symptoms of MS prior to Covid-19 vaccine, never was diagnosed with any type of immune system disease. The timing of these symptoms and the Covid-19 vaccine are impeccably correlated knowing my own body.
43 2021-05-25 pain in extremity, muscle spasms ON 01/19/2021, I HAD A SHARP PAIN IN MY LEFT CALF WHICH FELT LIKE A MUSCLE SPASM. FOLLOWING THIS I ... Read more
ON 01/19/2021, I HAD A SHARP PAIN IN MY LEFT CALF WHICH FELT LIKE A MUSCLE SPASM. FOLLOWING THIS I BEGAN HAVING EDEMA IN THE LEFT FOOT, ANKLE, AND LOWER LEG ASSOCIATED WITH PAIN. PAIN AND SWELLING WORSENED WITH PROLONGED STANDING DESPITE USE OF COMPRESSION SOCKS. VENOUS DOPPLER OF THE LEFT LOWER EXTREMITY OBTAINED AT MEDICAL CENTER ON 01/25/2021 SHOWED DVT. DR. ORDERED THE VENOUS DOPPLER AND THEN PRESCRIBED XARELTO FOR INITIAL TREATMENT. I FOLLOWED UP WITH MY PCP WHERE ADDITIONAL PRESCRIPTION FOR MAINTAINANCE XARELTO ANTICOAGULATION FOR A TOTAL OF 6 MONTHS WAS GIVEN.
43 2021-05-25 tingling all over fasciculations; paresthesia in right arm and leg; deep lower back pain/shoulder pain; deep ... Read more
all over fasciculations; paresthesia in right arm and leg; deep lower back pain/shoulder pain; deep lower back pain/shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 23Apr2021 11:00 (Batch/Lot Number: ER8731) as 2nd dose, single, at the age of 43-years-old for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included penicillin allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 10:30 lot number: EP7533, in the right arm. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After second vaccine on 23Apr2021, on 26Apr2021 she noticed delayed onset of symptoms which include all over fasciculations, paresthesia in right arm and leg, deep lower back pain/shoulder pain. These symptoms have not resolved and are undiagnosed. Lumbar X-Ray came back normal, Creatine Kinase and CRP levels came back normal, neurological strength/reflex test presented normal. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was not recovered. Follow up needed, further information has been requested.
43 2021-05-26 numbness Chills with fever after 2nd vaccine - 3 days Site of injection site red/swollen/painful-2 weeks Ti... Read more
Chills with fever after 2nd vaccine - 3 days Site of injection site red/swollen/painful-2 weeks Tightness/numbing in left arm-ongoing chest pain when bending forward and shortness of breath on the 4th day-1.5 days light headed-day 4
43 2021-05-26 muscle twitching Mild headache, soreness at site of injection, redness about the size of a quarter at site of injecti... Read more
Mild headache, soreness at site of injection, redness about the size of a quarter at site of injection, swelling at site of injection equivalent to about a quarter of a golf ball sliced long ways , hotness at site of injection, lower back pain, slight muscle twitching in upper arm - all relatively mild.
43 2021-05-26 tremor, weakness Became very fatigued, nauseous beginning around the 48 hours. Nausea would come and go and has last... Read more
Became very fatigued, nauseous beginning around the 48 hours. Nausea would come and go and has lasted over the course of the 60 hours proceeding the vaccine. I feel shaky and weak--which also comes and goes during the same time frame. Head feels "foggy".
43 2021-05-27 numbness, bell's palsy, throat numbness, tingling sore throat/her throat started hurting very bad and it does not have any signs of stopping; concerne... Read more
sore throat/her throat started hurting very bad and it does not have any signs of stopping; concerned about signs of Bell's palsy; numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips went numb/numbness was all over her face bilaterally/numbness tongue down her throat; numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips numb; numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips numb; lip and right cheek got very tingly/tingling in cheeks and lips; lip and right cheek got very tingly/tingling in cheeks and lips; pounding headache; lightheadedness and dizziness; severe left ear pain; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 13May2021 at 09:30 am (at the age of 43 years old) (Lot Number: EW0162; Expiration Date: Jul2021) as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient reported that she got the first dose of the Pfizer COVID-19 vaccine on 13May2021 at 09:30am. At 09:54am, she noticed her lip and right cheek got very tingly/tingling in cheeks and lips and at 10:04 am she had numbness that goes under her chin and down throat then from her tongue to the back of her throat/both cheeks and lips went numb. Then at 12:00 noon, the intense numbness was all over her face bilaterally and had numbness tongue down her throat. At 13:45, her throat started hurting very bad and it does not have any signs of stopping and so she is concerned about signs of Bell's palsy. The patient confirmed that she did not have loss of muscle control, she can still swallow and breathe. She confirmed that she has no signs of stroke. But had severe left ear pain since the vaccine. The patient did not think this is an emergency. She was told to report these to Pfizer. The patient was not sure if she should get the second vaccine and wondered if these were all normal. She declined to provide primary care provider details stating she hasn't been seen by one in a while. She stated that the soreness/hurting of throat was not there at first but is getting worse and also her tongue is also going numb and it's going down the throat. She did not have any weakness, but has pounding headache, some lightheadedness and dizziness, and sore throat on 13May2021. She has not been seen by provider and has not been to emergency room. She did call her family doctor and was instructed to go to the emergency room, but she wanted to see if the symptoms would subside first and notify Pfizer. No other vaccines given the same time on 13May2021 and no other vaccines 4 weeks prior. No problems with vaccines in the past. Outcome of the event severe ear pain was unknown, while not yet recovered from the remaining events. The events Bell's palsy, lip and right cheek got very tingly/tingling in cheeks and lips, numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips went numb/numbness was all over her face bilaterally/numbness tongue down her throat, sore throat/her throat started hurting very bad and it does not have any signs of stopping, pounding headache, and lightheadedness and dizziness were assessed as serious (medically significant). Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
43 2021-05-27 muscle spasms dizzy spells; lips swollen & burning; lips swollen & burning; inside cheeks covered with hive like s... Read more
dizzy spells; lips swollen & burning; lips swollen & burning; inside cheeks covered with hive like sores; hives on legs, arms, face; eyes swollen nearly shut/Day 8 swollen eyes/Day 14, 15, 16 random eye swelling; wheezing; Coughing; hard time breathing; all consuming itch in tips of fingers and toes/ hand/foot itch; swollen throat-hard to swallow; swollen throat-hard to swallow; chest spasm; sleepy; Days 2,3,4 lower back and uterus pain; uterus pain; extreme exhaustion; stiffness in joints; This is a spontaneous report received from a contactable consumer, the patient. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 13:00 (NDC Number: ndc 59267-1000-01) as a single dose (at the age of 43 years old) for COVID-19 immunisation. The patient medical history included unspecified allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 16Apr2021 at 07:30 the patient experienced lower back and uterus pain, extreme exhaustion and stiffness joints on 18Apr2021 swollen throat-hard to swallow chest spasm, sleepy; on 19Apr2021 eyes swollen nearly shut, wheezing/coughing, hard time breathing-used inhaler, all consuming itch in tips of fingers and toes, lips swollen & burning, inside cheeks covered with hive like sores, hives on legs, arms, face, took Allegra but no relief; on 20Apr2021 the patient experienced dizzy spells. The events resulted in Doctor or other healthcare professional office/clinic visit. The clinical course is as follows: Days 2,3,4 lower back and uterus pain; Day 5 same plus swollen throat-hard to swallow, chest spasm, sleepy; Day 6 same plus eyes swollen nearly shut, wheezing/coughing, hard time breathing-used inhaler, all consuming itch in tips of fingers and toes, lips swollen & burning, inside cheeks covered with hive like sores, hives on legs, arms, face, took Allegra but no relief; Day 7 same as day 6 + dizzy spells; Day 8 swollen eyes, hand/foot itch less severe but still consuming; Day 9 eyes less swollen, feet/hand itch less consuming; Day 10 manageable itchy feet/hands; Day 11 swollen eyes, itchy hands/feet increased intensity; Day 12 swollen eyes, itchy hands/toes less severe; Day 13 nothing; Day 14, 15, 16 random eye swelling, itchy feet/hands. About a week after last symptoms the patient started getting lower back pain, cramping in her chest and uterus again, it had been intermittent. The patient had been dealing with extreme exhaustion and stiffness in her joints since this all began. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative on 19Apr2021. Therapeutic measures were taken as a result of events wheezing/coughing, hard time breathing for which patient used inhaler, and hives on legs, arms, face for which patient took Allegra. No therapeutic interventions were taken for all other events. The clinical outcome of all events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
43 2021-05-27 muscle spasms Client received her second dose of the Pfizer Covid-19 Vaccine (Lot #EW0185 exp. 08/2021) on 5/27/21... Read more
Client received her second dose of the Pfizer Covid-19 Vaccine (Lot #EW0185 exp. 08/2021) on 5/27/21 at 09:41 AM. At approximately 1005 the client walked to the EMT station complaining of cramping on her right lateral side. EMT and RN responded. The client was a 43-year-old female who was alert and tracking with her eyes. The client had a chief complaint of shortness of breath. The client stated that she began to feel pain on her right side and that it was giving her mild shortness of breath. This was the client's second dose of the Pfizer vaccine. The client denied any known allergies or significant medical history. The client was not on medications. The primary assessment revealed that the client's airway, breathing, and circulation are intact. The client was negative for hives, swelling, discoloration, signs or symptoms of shortness of breath, or other signs of anaphylaxis. The client was alert and oriented to person, place, time, and event. The client stated that she ?did not have anything to drink? and was ?feeling a bit nervous?. EMT had the client lay down on the cot and took the first set of vitals at 1007 and were as follows: Blood pressure: 124/88, Pulse: 68 and regular, O2 saturation 98%, and lung sounds clear, respirations 20. The client then consented to stay an additional 30 minutes after her initial observation. After 5 minutes the client stated she was feeling better after drinking some water. The second set of vitals was taken at 1014 and are as follows: BP 122/82, pulse 72, O2 saturation 98%, lung sounds clear., respirations 18. After her first 15-minutes of observation, the client stated that she was ?feeling better? and refused to complete the remainder of her thirty-minute observation. All pertinent information was given to her and her husband by EMT and RN. The client was also instructed to call 911 if a severe allergic reaction occurred later in the evening and was educated on the signs and symptoms to watch out for. The client departed at 1020 in positive disposition with her husband.
43 2021-05-27 pain in extremity BP 129/86, 71, 97, Nominal sinus. Client c/o pain on left upper arm where the Pfizer vaccination wa... Read more
BP 129/86, 71, 97, Nominal sinus. Client c/o pain on left upper arm where the Pfizer vaccination was administered. Writer gave client an ice pack and client had an Advil tab that she took orally. Client then complained her right arm was hurting as well. Code red was called and the paramedics arrived and took client's vitals. Client's BP was 129/86, pulse 71, 20 breaths/min., pulse 97. Client once hearing her vitals were normal stated she felt better and was ok to go home.
43 2021-05-27 tingling The night I got the second dose my feet started tingling. Five days later my legs and hands started ... Read more
The night I got the second dose my feet started tingling. Five days later my legs and hands started tingling. I went to the urgent care and they told me to wait. Today I still felling my right hand and my left foot tingling.
43 2021-05-28 weakness, pain in extremity, feeling hot next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I c... Read more
next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; Hearing loss; tunnel vision; After a couple of minutes, started feeling faint/dizziness; weakness; nausea; got hot; started sweating excessively; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 07Apr2021 20:15 at age of 43-year-old (Batch/Lot Number: Ew0151) at single dose for COVID-19 immunization. Medical history included know allergies to wheat. The patient is not pregnant at the time of report. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no other vaccine in four weeks or other medications in two weeks. After a couple of minutes on 07Apr2021 at 20: 30, the patient started feeling faint. Hearing loss, tunnel vision, dizziness, weakness, nausea, got hot and started sweating excessively. The patient was able to walk with assistance after 20-25 minutes. The patient also developed sore arm on 07Apr2021, then the next night of 08Apr2021, she couldn't sleep because she was itchy and feeling ticking all over her body. The events did not result in emergency room visit or physician office visit. There was no treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Apr2021.
43 2021-05-28 tingling At 10:12am, this nurse notified that attendee had complaints of dizziness and lightheadedness. On-si... Read more
At 10:12am, this nurse notified that attendee had complaints of dizziness and lightheadedness. On-site fireman notified. Fireman at side and vital signs at 10:14am: blood pressure 148/82, pulse 99, temperature 97.4F, respirations 22, O2 sats 100% on room air. At 10:14, attendee had complaints of "throat feeling weird" and "upper lip quivering" and "fingertips tingling". Attendee states she has a history of anxiety and has these same symptoms with anxiety attacks. Fireman encouraged patient to slow her breathing. Vital signs at 10:30am: blood pressure 135/80, pulse 81, respirations 20, O2 sats 99% on room air. Daughter present with patient. Attendee stating she was feeling better and more calm and that she did not feel the need to go to the hospital and that sensation of lightheaded and dizzy have passed. Attendee instructed to have her daughter drive home and to contact urgent care or her primary physician if she had any other concerns/issues upon leaving the vaccination site or upon returning home or later in the day. Attendee ambulated out of facility with daughter at about 10:42am. No acute distress noted.
43 2021-05-31 tingling Sharp pain in ear that comes in goes morning after shot that lasted two days. Slightly swollen front... Read more
Sharp pain in ear that comes in goes morning after shot that lasted two days. Slightly swollen front inner part of right shoulder (NOT the arm that was injection) just outside bra strap, two days after shot up to present. Right arm also felt tingly. I took Ibuprofen once last week as well as yesterday and today to see if that would help with inflammation; so far it has not.
43 2021-06-01 numbness, facial pain, tingling Within a half hour to 45 minutes post injection, I started having a sharp pain in my left eyebrow. o... Read more
Within a half hour to 45 minutes post injection, I started having a sharp pain in my left eyebrow. over the next hour or so, the pain worsened around my left eye, and I noticed a numbness in my forehead and upper cheeks (Similar feeling to botox but also slightly tingly). The discomfort lasted throughout the evening. By bedtime, I was extremely fatigued and having feverish symptoms (chills, aches, headache, fatigue) though my body temp was not elevated much. When I woke up the next morning, my temperature was increasing, chills and body aches were worse. I was somewhat expecting that, given accounts from others. Highest temp was 102.8 over the next 24 hours. But most concerning was my resting heartrate was elevated all day (tracked via apple watch). My resting HR even while sleeping was from the upper 80s and as high as 103 bpm. After bedtime that night, I started having pretty severe body aches in my torso. Most of the other aches had lessened but these got worse, preventing sleep, and lasted through most of sunday 5/30. By evening, I felt much better, and by Monday, I was back to normal, all symptoms gone.
43 2021-06-01 pain in extremity, myelitis transverse sharp shooting pain; she can barely walk; felt like she was hit with a cannonball; bedridden; to be ... Read more
sharp shooting pain; she can barely walk; felt like she was hit with a cannonball; bedridden; to be isolated in part of her lower back and her glutes/back is destroyed/it dissipated to her lower back and glutes and is extremely painful; She can barely move/can barely move, barely get in and out of cars, barely stand up from sitting position; Arm is not sore anymore at all; transverse myelitis; barely stand up from sitting position; panic; inflammation of my lower spine; kind of distracted; difficulty with normal everyday functions; She had muscle aches/All caller's muscle are sore/she had muscle pain in all of her body; fever; Eyes weren't burning anymore/burning eyes; to be isolated in part of her lower back and her glutes/it dissipated to her lower back and glutes and is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the arm left on 11May2021 at 15:00 as single dose for COVID-19 immunisation. Medical history included stomach issues, ongoing lyme disease (this condition started and diagnosed about 10 years ago), hay fever, dust allergy, pollen allergy, animal dander allergy, motion sickness (this condition started probably before Lyme), patient said she got sick when she goes on boat; every time she was on a boat she lost her lunch. Family medical history included diabetes, but the patient has never had diabetes. Concomitant medications included ongoing promethazine for stomach issues (it is antihistamines, nothing radical and taking it since got Lyme disease about 10 years ago), ongoing Belsvia. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 21Apr2021 at 14:30 (at the age of 43 years old) as single dose for COVID-19 immunization. The patient previously also received the flu shot several months before. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No AE(s) following prior vaccinations. The patient got her second Pfizer covid vaccine on May 11 and felt like she was hit with a cannonball and was bedridden for a day. She had muscle aches on 12May2021 which she expected but now they seem to be isolated in part of her lower back and her glutes and it seems to be getting worse. Patient can barely move, sit down or stand up and it was a sharp shooting pain. All her other muscle pains have resolved. On 12May2021, patient had muscle aches which though was normal for the first couple of days and so most of the muscle aches went away except the patient back was destroyed that reported as worsened. Stated it was that side of the body in pain. The patient was trying to sit up right now and was having really sharp shooting pain on back. The patient figured this would have resolved itself by now. Stated she was kind of scared this might not go away. On 12May2021, patient arm was not sore anymore at all and eyes weren't burning anymore. The arm was sore day the day after receiving the second dose Pfizer Covid Vaccine, 12May2021. On 12May2021, patient had a fever and about 24 hours the fever lasted; could barely move; burning eyes that back to normal and also lasted for 24 hours. The patient can barely move after receiving second dose Pfizer Covid Vaccine, sharp shooting pains, really, really bad. The patient can barely move, barely get in and out of cars, barely stand up from sitting position. The patient assumes this was a side effect of the second dose Pfizer Covid Vaccine and was it would dissipate by now, but it was getting worse and worse. The patient stated the pain was now isolated to the lower part of her back on the gluts. All muscles were sore, started to get worse, all muscles in whole body were sore but it was now isolated to that area. That was a really big deal, patient can barely function. Thought it would get better, thought it would resolve but it is getting worse. The patient can barely stand up or sit down, that's how bad the pain was. Patient stated it was a pure, really sharp pain and the patient got stuck. The patient got stuck taking a piddle on the toilet for like 15 minutes after the patient first received the second dose Pfizer Covid Vaccine. Patient thought it would go away. All patient's muscle were sore. Noticing it was isolated in that specific area. Pretty much the patient's whole body function was like lower back, whole gluts almost, mainly on injection side. Stated all soreness in whole body, like hit by a cannon ball. The pain in rest of muscles dissipated, they felt normal but the muscles above the gluts, patient's whole function, whole body function was obliterated right now. Whenever the patient tries to move, had a sharp piercing pain. The patient tried to make sure she slept good and in good positions and everything. The patient states she was kind of distracted. Patient can barely walk, she's experiencing sharp shooting pain and difficulty with normal everyday functions (she's been bedridden because even going to the toilet was a big deal, she got stuck and was unable to get up and sit down), she's concerned because the other side-effects resolved but she got the vaccine a week ago and it's getting worse, she had muscle pain in all of her body and it dissipated to her lower back and glutes and was extremely painful. Patient also had burning eyes but this symptom went away and fever. She would like to know if anyone else has experienced anything like this and if it's normal to experience these side-effects, particularly the severe debilitating muscle pain 7 days after the second dose of the vaccine because she still has this symptom and it's getting worse. Patient said she was stuck lying in bed. She said if she switches sides she got the sharpest pain and it was like she gets it in her organs, like her lung was being punctured. Her primary care didn't know her well enough to give her anything for the pain for a couple of days. The pain was sharp, shocking. She felt like its in her hips; she can't even use toilet on her own, it takes forever. She was un-functionable and obliterated. The walking issue started a couple days after the vaccine. It was with all the muscles in her body, she was bedridden. She expected it to resolve. She said it isolated to that area, ironically her arm wasn't sore anymore, nothing else, but she was extremely sore in that area in her glutes. It was getting worse and it made her panic, she was not walking, she was handicapped, she was completely crippled. Also said the muscle pain started the day after her vaccine and went for 7 days after. The difficulty walking start day was hard to say; it was a gradual manifestation and it was not like all of the sudden she got the shot and can't walk. It was several days getting worse and now was is sort of in demise. Clarified these events occurred after her second vaccine, she had no problems with the first. Patient also stated she thought she had developed transverse myelitis, inflammation of her lower spine from the vaccine, from second Pfizer vaccine, side effect, she can barely move. AE(s) did not require a visit to emergency room, for events not being able to barely walk and being in extreme pain that resulted in physician office visit and she went to the doctor's on 17May2021. No surgeries to report. Lab data included body height was 160 cm or 5 feet, 3 inches; patient weight was like 145 pounds. The outcome of events fever, burning eyes was recovered on 13May2021. The outcome of events transverse myelitis, feeling abnormal, bedridden, Movements reduced, Pain in arm, Panic disorder, Spondylitis, Distractibility was unknown; while of the other events was not recovered.
43 2021-06-02 numbness, tingling Numbness and tingling down left shoulder, arm and into hand. Numbness and tingling of left side of ... Read more
Numbness and tingling down left shoulder, arm and into hand. Numbness and tingling of left side of face (forehead, cheek, mouth, chin).; Numbness and tingling down left shoulder, arm and into hand. Numbness and tingling of left side of face (forehead, cheek, mouth, chin).; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0169), at the age of 43-year-old, via an unspecified route of administration, administered in Arm Left on 18May2021 10:00 at single dose for COVID-19 immunisation. Medical history included endometriosis, dermatographic urticaria (autoimmune condition), and nonallergic rhinitis. Concomitant medications included progesteron; estradiol (ESTROGEN); diltiazem. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had numbness and tingling down left shoulder, arm and into hand. Numbness and tingling of left side of face (forehead, cheek, mouth, chin) on 18May2021 16:00. Been in contact with her physician. Has not resolved in 24 hrs. Treatment received for the events and included antihistamines, anti-inflammatories. The event resulted in physician office visit. The outcome of the event was not recovered.; Sender's Comments: The causal association between the reported events and vaccine administered cannot be excluded based on a plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
43 2021-06-02 pain in extremity I began to have reddened areas as well as blanched (reynaud-like) areas on my hand as well as areas ... Read more
I began to have reddened areas as well as blanched (reynaud-like) areas on my hand as well as areas of what appeared to be micro vascular clots. I had swelling on one fingertip. Fingers were painful. I had something similar on my big toes
43 2021-06-02 paralysis Within 30 minutes of receiving the 1st dose of the covid19 vaccine in my left shoulder my left hand ... Read more
Within 30 minutes of receiving the 1st dose of the covid19 vaccine in my left shoulder my left hand and wrist became completely paralyzed.; Ulnar Palsy; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207, expiration date not provided), 1st dose via an unspecified route of administration, administered in arm left on 16May2021 15:30 at age of 43 years old as a single dose for COVID-19 immunisation. Medical history included latex sensitivity. The patient's concomitant medications were not reported. The patient experienced within 30 minutes of receiving the 1st dose of the COVID-19 vaccine in her left shoulder her left hand and wrist became completely paralyzed on 16May2021 16:00. The ER said it was random coincidence and diagnosed it as Ulnar Palsy on 16May2021 16:00. The events were reported as being disability. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. The adverse event resulted in visiting doctor or other healthcare professional office/clinic. The adverse event result in visiting Emergency room/department or urgent care. Treatment for the adverse event was included ER (emergency room) Exam. The patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
43 2021-06-02 throat numbness, numbness Received her second dose Pfizer vaccine (LOT#: EW0185 EXP: 8/2021) at 1450 on 5/25/21. Patient alert... Read more
Received her second dose Pfizer vaccine (LOT#: EW0185 EXP: 8/2021) at 1450 on 5/25/21. Patient alerted EMT at 1514 about 24 minutes after her vaccine. Patient stated that she felt heat radiating from her vaccine site to the right side of her face and right cheek region. Patient stated that the heat turned into numbness throughout the same region. Patient was given water. Patient was able to swallow water without any difficulty. Patient denied any SOB. EMT took patients vitals at 1516. BP: 119/98, pulse: 86, O2: 97%. PHN asked patient to stay an extra 30 minutes for further observation. Patient agreed to stay an extra 30 minutes. PHN offered patient Diphenhydramine 2x 25mg/mL. Patient agreed to take Diphenhydramine. PHN gave Diphenhydramine to patient at 1523. EMT reassessed and retook patient vital signs at 1528. BP: 130/90, pulse: 64, O2: 96%. Patient stated that her symptoms had not changed and were still similar. EMT reassessed and retook patient vital signs at 1533. BP: 120/83, pulse: 86, O2: 96%. Patient stated that her symptoms decreased but were still present. EMT reassessed and retook vital signs at 1538. BP: 110/81, pulse: 87, O2: 95%. Patient stated that she still felt numbness throughout her right cheek and right arm but no longer felt numbness in her neck or throat. EMT reassessed and retook patient vital signs at 1553. BP: 115/82, pulse: 85, O2: 95%. Patient stated that her symptoms were only present in her upper right arm and the numbing had decreased. Patient was talking to EMT throughout observation time. Patient had completed observation time. Patient was reassessed by EMT. Patient stated that she was feeling a lot better. Patient was educated on worsening signs and symptoms of the vaccine and when to call EMS or go to urgent care/emergency room. Patient verbalized understanding of education. Patient walked out of vaccination site at 1555 unassisted and with a steady gait.
43 2021-06-02 tenderness On 01/22/2021 around 2 PM I noticed the spot between my clavicle was tender and it was that way for ... Read more
On 01/22/2021 around 2 PM I noticed the spot between my clavicle was tender and it was that way for a couple days. I didn't take any medicine, only monitored. It subsided by that following Monday 01/25/2021 and It was completely gone by then. I did not see my PCP but my friend that is a nurse said that I could have sub clavicular lymph nodes.
43 2021-06-03 weakness Has not had any energy; it's hard to breath with no oxygen in her blood; it's hard to breath with no... Read more
Has not had any energy; it's hard to breath with no oxygen in her blood; it's hard to breath with no oxygen in her blood; Had been checked for anemia in Apr2021 and told she was anemic/ iron has been low; period still ongoing and strong, really heavy bleeding with clots; prolonged bleeding with periods; This is a spontaneous report from contactable consumer (patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 22Mar2021 09:00 at the age of 43-years-old (Lot Number: EN6204) as single dose for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as first dose on 01Mar2021 at the age of 43-years-old for COVID-19 immunization (Lot Number: EN6198, Anatomical Location: left arm); started period couple days early after first vaccine from Mar2021, caller reported she got the first Pfizer BioNTech vaccine and shortly afterwards she started her period, which was a couple days early, but it didn't stop for 10 days. It was really, really heavy bleeding along with clots and things. Medical history was none. The patient's concomitant medications were not reported. The caller asked if prolonged bleeding with periods was a side effect of the vaccine. She stated she had both doses of the vaccine and had this issue with both. She stated she knows there has been other woman who have come forward saying they have these things. At the time, her doctor had not heard anything about any reactions to it. Her iron has been low and she got tested for anemia and was anemic now. She has had her second period since the vaccine and was on day 16 of period. It was still going on strong and she was wondering if this was something that Pfizer has heard of happening after the vaccine. She had first BionTech vaccine on 01Mar2021 and her period started a day or two after that. It had gotten worse, but did subside. She was normally super regular and super normal with her periods. Stated she did have another small period in between the first and second vaccine, but that only lasted for a day, which was really weird for her and did not usually happen. Had the second dose 3 weeks after the first dose on 22Mar2021 and a couple days after that her period started and she was now on her period and on Day 16 and it's gotten worse. This one stared early May, 03May2021 and was also still going strong and really wants this to be resolved since going on her honeymoon soon. Caller clarified event of periods. She had been checked for anemia in Apr2021 and told she was anemic. Has also gone to specialist to see what's going on. They suggested a biopsy to rule out that there was nothing else going on. If nothing else works they are talking about doing an ablation to stop the bleeding or a partial hysterectomy, where they just take the uterus, since they know that's causing her anemia and since the bleeding won't stop long enough for her to get her blood supply back up where she needs it. Has not had any energy and it's hard to breath with no oxygen in her blood. Physician office was for period still ongoing and strong, really heavy bleeding with clots, iron low, anemic, no energy, hard to breath with low oxygen in blood, saw a specialist. The patient experienced period still ongoing and strong, really heavy bleeding with clots in Mar2021; prolonged bleeding with periods in Mar2021; had been checked for anemia in Apr2021 and told she was anemic/ iron has been low; Has not had any energy; it's hard to breath with no oxygen in her blood. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021568087 same patient/drug and different dose/event.
43 2021-06-03 muscle twitching 2 days after the 1st vaccine, my left cheek began twitching; 2 weeks after 1st vaccine I began exper... Read more
2 days after the 1st vaccine, my left cheek began twitching; 2 weeks after 1st vaccine I began experiencing vertigo that is now intermittent; This is a spontaneous report received from a contactable consumer or other non hcp. A 43-years-old non pregnancy female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number EL3249), via an unspecified route of ad-ministration, in Arm Right on 19Jan2021 12:45pm (age at vaccination 43years old) as single dose for covid-19 immunisation. Medical history included hypertension, asthma from an unknown date and unknown if ongoing. The patient previously took promethazine dm and experienced drug hyper-sensitivity. No covid prior vaccination. Concomitant medications were not reported. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9269,), via an unspecified route of administration in arm right on 12Feb2021 04:30pm as a single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received other medications in two weeks. Patient inquired that while administer her 1st dose, On 20Jan2021 the patient experienced 2 days after the 1st vaccine, her left cheek began twitching. This intensified after the 2nd vaccine and she is now experiencing pain, numbness, tingling in the area. The left half of her lips also has numbness. 2 weeks after 1st vaccine I began experiencing vertigo that is now intermit-tent. Treatment was received for the events with steroids and Dramamine. No covid tested post vaccination. The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
43 2021-06-03 pain in extremity, tingling Tingling in arm, arm sore to touch, dry mouth, nauseous, headache
43 2021-06-03 pain in extremity Right deltoid muscle ache began within 1 hour after injection and resolved within 24 hours. Muscle a... Read more
Right deltoid muscle ache began within 1 hour after injection and resolved within 24 hours. Muscle and joint pain in entire body began on 6/2/2021 at about 3 a.m. and resolved on 6/3/2021 at about 8 a.m. Headache, chills, fever, and a dry cough began on 6/2/2021 at 4 a.m. The fever fluctuated between 99.5 degrees F and 101.3 degrees F. The chills and fever resolved on 6/2/2021 at 10 p.m. The headache resolved on 6/3/2021 at 10 a.m. The headache was frontal type pain in the forehead with sensitivity to light. The dry cough is still ongoing right now on 6/4/2021 at approximately 6:15 a.m. It is a dry, non-productive cough, worse during the day and less at night.
43 2021-06-03 tension headache, cold extremities Immediately after receiving my first shot, blood pressure shot up to 148/60 (normally 120/60 or less... Read more
Immediately after receiving my first shot, blood pressure shot up to 148/60 (normally 120/60 or less), heart racing, felt dizzy, and legs felt funny, heavy. This higher heart rate persisted throughout the first day and evening, and on day 2 I woke up with wheezing and was sent to the ER. Blood pressure readings there were the same. Had a headache for three days also. On day 3, started feeling slightly better, but then awoke with lightheadedness, brain fog, tinnitus, and the feeling of a tight scalp. This persisted for two more days. On 6/1 was seen in outpatient care with blood pressure still higher (138/60), and tinnitus, with lower legs feeling like they were in cold water.
43 2021-06-03 tremor At approximately 1442, client reports to nurse feeling dizziness, sweating, shakiness, palpitations ... Read more
At approximately 1442, client reports to nurse feeling dizziness, sweating, shakiness, palpitations and blurred vision and stated ? it feels like my sugar is low.? Patient reported she did not have glucometer and had been feeling like this for 10 minutes. EMT assessed patient vitals: blood pressure 140/90 mmHg, pulse 110 beats/minute and SpO2 99%. Patient reported history of diabetes mellitus type 2, asthma, leukemia, and ovarian cancer. Patient reported taking metformin, insulin, and an inhaler. At 1443, nurse activated EMS. At 1451, paramedics arrived and assumed care. Patient blood sugar was 123. Patient declines transport to hospital and signed Against Medical Advice form. At approximately 1500, paramedics left facility. Patient vitals reassessed at 1505: blood pressure 130/90 mmHg, pulse 102 beats/minute, and SpO2 99%. Patient stands up and reports feeling dizzy again. Nurse offered crackers. Patient consumed crackers and stated she felt better and was not dizzy anymore. At 1316 lead nurses assisted patient who is pushing her mother in a wheelchair to her vehicle. Patient left facility with steady gait and unlabored respirations.
43 2021-06-03 trigeminal neuralgia Trigeminal Neuralgia; This is a spontaneous report from a contactable consumer (patient). A 43-year-... Read more
Trigeminal Neuralgia; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration in Arm Left on 24Feb2021 at 09:30(at the age of 43 years old) as 2nd dose, single dose for covid-19 immunisation at Health Clinic. Medical history was none. Known allergies was none. Other vaccine received in four weeks included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9810) via an unspecified route of administration in Arm Left on 03Feb2021 as first dose, single dose for covid-19 immunisation. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication. The patient was not tested covid prior to vaccination. On 25Feb2021 at 20:00 the patient experienced trigeminal neuralgia. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Reporter reported as, "Doctor suspects a diagnosis of Trigeminal Neuralgia. Referred to a neurologist for confirmation and treatment plan". Therapeutic measures were taken as a result of trigeminal neuralgia. Treatment received as, medication to help with inflammation and pain. The patient was not tested for covid post vaccination. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
43 2021-06-03 unresponsive to stimuli, tremor Patient received her first dose of the Pfizer vaccine at 2:27PM and was under observation for 30 min... Read more
Patient received her first dose of the Pfizer vaccine at 2:27PM and was under observation for 30 minutes. Patient did not report any symptoms/side effects while under observation and left the facility when her 30-minute period was up. Patient returned to Building with her spouse at approximately 3:10PM with tremors and reported feeling anxious because she believed the vaccine needle was still in her arm. Our team reassured her that this wasn?t the case, the RN explained that we use retractable needles for safety reasons, and we asked the patient to stay for additional observation. At approximately 3:35PM, patient?s spouse called for assistance because patient was not responding. Patient was assessed by our MD lead and was unresponsive to verbal stimuli but responsive to physical stimuli; BP was within normal limits. MD lead and spouse escorted patient to ED via wheelchair at approximately 3:45PM for further evaluation.
43 2021-06-04 involuntary muscle movements tired; pain in my left arm pit; I felt around its very swollen; It feels like swollen lymp node but ... Read more
tired; pain in my left arm pit; I felt around its very swollen; It feels like swollen lymp node but its large; having issues lifting my arm due to the pain; spiked a temp of 103.5; didnt feel well in the evening; This is a spontaneous report from a contactable Nurse (patient). 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 12:30 (Batch/Lot Number: Ew0186) as 2ND DOSE, SINGLE for covid-19 immunisation. Patient received the first dose on 29Apr2021. Medical history included asthma and migraine. Concomitant medication included butalbital, caffeine, paracetamol (FIORICET) taken for an unspecified indication, start and stop date were not reported. After the first dose, I had a terrible migraine. I Took medication it didn't work. After the second dose, from 20May2021 21:00, I didn't feel well in the evening, was tired the following day. During the evening I spiked a temp of 103.5, took Tylenol. I feel a little better but still not well. I took a shower and had pain in my left arm pit. I felt around it's very swollen. It feels like swollen lymp node but it's large. I'm having issues lifting my arm due to the pain. Patient also felt tired on 20May2021. Outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
43 2021-06-06 involuntary muscle movements, speech disorder, inability to speak, numbness and pain in extremities The night of the vaccine, around 11 pm, I started getting hard hitting right sided muscle fasciculat... Read more
The night of the vaccine, around 11 pm, I started getting hard hitting right sided muscle fasciculations that developed all along the nerve path endings in the right side of my face (this lasted until 29 MAY 2021 - I have had a history of this, which included blepharospasm and right sided facial muscle fasiculations x4 years, but they have been non existent past few years). My resting head tremor came back, which I haven't had in like 2 years (it is pretty much gone now, but it lasted until 29 MAY 2021 and it only happens at rest). I started getting heart palpitations the night of the vaccine (they lasted until 29 MAY 2021). I went to bed, woke up the next day, and those aforementioned symptoms continued all day long, PLUS my phrenic neuropathy came back, which I haven't had in like 4 years. With that, I get intense stabbing in the tip of my left shoulder, my LUQ/Spleen area, and lower left side of spine, and the stabbing occurs in all 3 spots simultaneously. That lasted for DAYS 2, 3, 4 after getting the vaccine. When this flared up before, my family doctor told me the pain in the tip of the left shoulder is called "referred pain" because the problem is actually with the diaghragm and how the phrenic nerve runs through the diaphragm up through the neck. Anyways, the vaccine flared up my pain for 3 days. It is 10/10 stabbing pain that takes your breath away and makes me freeze when i get it, but the pain is short. It is like 3-5 stabs, then it goes away for like a couple hours, then comes back. That lasted for days 2,3,4 after the vaccine. I also was having problems with depth perception and was having problems gaging myself going down steps. My balance was perfectly fine, though.. i just couldn't gage where i was as i was moving too well. I was also having confusion, loss for words, and problems speaking. My mouth muscles weren't working right and it was frustrating because it was making me stutter. I felt extreme muscle fatigue in all 4 extremities, like it felt like I ran a marathon. All those symptoms lasted until 29 MAY 2021, except the phrenic neuropathy was only those 3 days after the vaccine. Today is 7 JUN 2021 and I feel fine now. I am still having a little bit of jerky movements but not bad overall. Because I have had a history of all these same exact movement issues in the past, I did not go to the doctor, because I have been through this before, since i have lived with this for 7 years now, and again I wanted to reiterate that I have been without issues for 2 years, so being that my issues started the day i got the vaccine, it is likely my body had a neurological flareup due to my body's immune response to the vaccine. I have an appointment with a doctor tomorrow to discuss.
43 2021-06-06 feeling hot Client stated, "I am having heart beating fast, I feel hot, and I feel like it's hard to breathe." ... Read more
Client stated, "I am having heart beating fast, I feel hot, and I feel like it's hard to breathe." symptoms lasted 2 minutes, then completely resolved after rest, water, snacks given and laying supine in gravity chair.
43 2021-06-06 numbness and pain in extremities, tremor I experienced a muscle tension and neuroprosy. I have internal trimmers and he external arm trimmers... Read more
I experienced a muscle tension and neuroprosy. I have internal trimmers and he external arm trimmers. I've also been bleeding heavily for every two weeks.
43 2021-06-07 weakness, tremor, numbness HIGH UNCONTROLLED PRESSURE, DROWNING (LACK OF BREATHING), SHAKY HANDS, HAND AND FEET NUMBING, LACK O... Read more
HIGH UNCONTROLLED PRESSURE, DROWNING (LACK OF BREATHING), SHAKY HANDS, HAND AND FEET NUMBING, LACK OF ENERGY, DIZZINESS, SWEATING, PALPITATION (TACHYCARDIA). TREATMENT; LEUTIROX 112, LOSARTAN 50 VITAMINS B12; VITAMIN C; VITAMIN D; ZINC REST FOR SIX WEEKS FORBIDDEN DRIVING. IN JULY TAKE OTHER CBC BLOOD CHEMISTRY GENERAL URINE EXAMS. TEST RESULT HIGH PROTEINS, ALBUMIN, MCH MCHC MPV AND CHOLESTEROL OUT OF RANGE (HIGH).
43 2021-06-07 electric shock sensation, tingling, pain in extremity Vertigo and dizziness onset about 2 minutes of receiving 2nd shot. Sudden tingling in nose and weird... Read more
Vertigo and dizziness onset about 2 minutes of receiving 2nd shot. Sudden tingling in nose and weird taste in mouth. Racing heart. Pharmacist administered Epi Pen, and I was transported to the ER via Ambulance. Vertigo, dizziness, giddiness ever since. Shortness odd breath, not resolved yet either. Developed Atypical Pneumonia 6 weeks after second shot. Leg pain when resting. Heart palpitations, and heart pounding. Unusual heavy, long and incredibly painful Menstruation after first shot. Feeling of difficulty swallowing after second shot for several days. Feeling of "electrical" mini shots in random places of my left side (inner thigh, underside of arm, in my eye etc.). Off and on ear sounds left ear. Joint/foot pain left foot after first shot.
43 2021-06-07 pain in extremity Sore arm for 24 hours; This is a spontaneous report from a contactable Consumer (patient, reported f... Read more
Sore arm for 24 hours; This is a spontaneous report from a contactable Consumer (patient, reported for herself) A 43-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: UNKNOWN) via an unspecified route of administration in Arm Left on 25Feb2021 17:15 as SINGLE DOSE for covid-19 immunization at pharmacy or drug store. Lot unknown reason other, not given info by pharmacist. Patient Medical history, known allergies included Drug allergy to Codeine and morphine. Other medical history included congenital heart Defect from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (Other medications in two weeks) included: digoxin (LANOXIN), lisinopril, furosemide (LASIX [FUROSEMIDE]), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and multivitamin all taken for unspecified indications, doses, unspecified dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since the vaccination. On 25Feb2021 at 22:30 patient experienced sore arm for 24 hours. Patient did not received treatment for the adverse events. The patient was not tested for COVID post vaccination. Event Sore arm for 24 hours was non-serious. Outcome of the event was reported as recovered on an unspecified date. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
43 2021-06-07 pain in extremity The first day, I had nausea and a huge headache. I think they shot me too high - pain when I moved m... Read more
The first day, I had nausea and a huge headache. I think they shot me too high - pain when I moved my arm for about a week - around rotator cuff. About a week later, I had stomach aches all week and diarrhea for a week - nothing changed in my diet so don't know what caused it. When the bump developed on the 23rd - mass developed on upper right forehead - goose egg developed. I had not bumped my head .I used some ice that night. When I woke up the next day, mass was much bigger - pushed on eye and eye brow. Pre-septal Cellulitis - diagnosis - entire forehead swelled up almost to the point that right up was completely closed up. Put on antibiotics. It didn't go down the first few days - I'm allergic to many antibiotics (had to switch it three times). They cut the infection out - there was a bunch of bacteria that got squeezed out. I had to have the infection cut out three times - because the swelling wouldn't really go down. I did a course of antibiotics for 10 days - Augmentin - 500 mg. I still have a slight bump there - probably scar tissue.
43 2021-06-08 weakness Update: 1st day 5/27/2021 afterwards I had to leave work early bc I was dizzy, nauseous, body aches,... Read more
Update: 1st day 5/27/2021 afterwards I had to leave work early bc I was dizzy, nauseous, body aches, very weak. Day 2 was better in the morning but as the day went more body aches and headaches. Towards the end of day 2 I can?t taste anything. Day 3 sinus is all the getting on my last nerves. Nose running, head congestion, body aches, and still can?t taste anything. Now I don?t know if it?s just my allergies bc I was in pollen a little bit yesterday. PLEASE understand that I am sensitive to foreign things and have had reactions to other vaccines.
43 2021-06-08 discomfort Second dose of Pfizer 4/9/21 and was admitted with low level positive troponin after symptoms for 1 ... Read more
Second dose of Pfizer 4/9/21 and was admitted with low level positive troponin after symptoms for 1 week (posterior neck discomfort radiating to jaw and shoulder along with nausea, feeling uncomfortable, discomfort in upper chest).
43 2021-06-08 hot flush Approximately 2 weeks after receiving the second Pfizer vaccination, I started to have multiple hot ... Read more
Approximately 2 weeks after receiving the second Pfizer vaccination, I started to have multiple hot flashes per day. I have never had even one hot flash in my entire life. I thought I was coming down with something, but they have continued each day several times a day. I did have severe fatigue, vertigo, and brain fog for at least 1. 5 weeks afterward as well, but those have dissipated at this time.
43 2021-06-08 numbness, burning sensation Burning sensation followed by numbness starting at the injection side (left) going up to the left e... Read more
Burning sensation followed by numbness starting at the injection side (left) going up to the left ear and left rear head.; Burning sensation followed by numbness starting at the injection side (left) going up to the left ear and left rear head.; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 15May2021 (at the age of 43-year-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any medications within 2 weeks of vaccination and any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced burning sensation followed by numbness starting at the injection side (left) going up to the left ear and left rear head, which resulted in doctor or other healthcare professional office/clinic visit. Patient stated it persisted for about 2.5 weeks after the first shot. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
43 2021-06-08 muscle twitching, flushing Flushed face; face twitching; Light headedness; This is a spontaneous report received from a contact... Read more
Flushed face; face twitching; Light headedness; This is a spontaneous report received from a contactable healthcare professional. A 43-year-old, non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 17Mar2021 at 15:00 PM (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included Diabetes Type 2 from an unknown date. The patient reported being allergic to Penicillin and Sulpha. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. On 17Mar2021 at 15:00 PM, the patient experienced flushed face after the vaccine was administered. He also felt both sides of the face being twitched and light headedness. The patient did not receive any treatment for flushed face, twitched face and light headedness. The clinical outcome of flushed face, twitched face and light headedness were reported as not recovered. Information about Lot number cannot be obtained. No further information is expected.
43 2021-06-09 numbness, tingling Patient came up after about 15 minutes and stated her arm felt numb and tingly. She stated she was n... Read more
Patient came up after about 15 minutes and stated her arm felt numb and tingly. She stated she was not having any other symptoms and felt okay. Her arm just felt asleep.
43 2021-06-09 pain in extremity, migraine migraine headache disease; her eye is producing gunk; Almost kind of like pink eye; felt like a thou... Read more
migraine headache disease; her eye is producing gunk; Almost kind of like pink eye; felt like a thousand needles are in the patient's eye; losing her vision; Blurriness; maybe allergies; arm started hurting worse than it did after the caller received the first dose; throat is all scratchy; spot where the caller received the second dose Pfizer Covid Vaccine was sort of hard to the touch; This is a spontaneous report from contactable consumer (patient herself). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right upper arm on 19May2021 (Batch/Lot Number: EP6955) as 2nd dose, single for COVID-19 immunisation. The patient had no relevant medical history and no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right upper arm on 28Apr2021 (Batch/Lot Number: EW0176) as 1st dose, single for COVID-19 immunization and experienced arm started hurting, felt like had a flu, started losing voice, had a hard spot, being lethargic, and had a hoarse voice. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 19May2021, the patient received her second dose Pfizer Covid Vaccine and her arm started hurting worse than it did after she received the first dose Pfizer Covid Vaccine. The patient has started losing her voice. The worst thing of it was, the patient was now losing her vision. She cannot see anything close up, all blurry. This began the next day after receiving the second dose Pfizer Covid Vaccine, 20May2021. She probably wouldn't have thought much of it, mentioned it to her husband, who was a medic. The patient's husband said something like allergies increase. She ignored it and the next day she had an online appointment with someone and that person mentioned the patient was clawing at her eyes. That was when the blurriness started. The white of her eye was not red, but during the day her eye was producing gunk. Almost kind of like pink eye. She wakes up in the morning and has gunk in her eye. The patient had been putting Visine Red Eye Comfort (lot numbers: KAB6601, expiration date: Jan2023) in her eye and it was not helping. She read online and searched and found a woman who lost her vision after receiving the Pfizer Covid Vaccine. She said Pfizer's list stated inflammation may be possible and a list of more serious side effects listed was eye blurriness. Sher stated her vision was getting worse every day. The worst thing of it was now losing vision. If she closes her eyes like a little bit more than just blinking, closes where put eyelids together, this felt like a thousand needles are in the patient's eye. Everyday her eyes have gotten worse. For example, while watching a program on television, she could not tell the faces of the people and said she didn't know what was going on. Because it was so blurry, she thought maybe it was screen time and she tried everything. Today, the patient was quiet worried and it seemed like it has progressed. It had multiplied, everyday it gets worse by 20%. It was twice as bad today as it was yesterday. The patient was a little frightened. The patient's throat was all scratchy. She had a headache but said that was kind of normal. She gets headaches on a daily basis, but the headache was not going away. She had migraine headache disease and doesn't think she had headaches because of the second dose Pfizer Covid Vaccine. The patient stated she has quarantined and hasn't gone anywhere, no group stuff, nothing. She was afraid it's from the Pfizer Covid Vaccine, it was maybe allergies, even though she has never had allergies her whole life. If it was not pink eye, the patient did not want to take antibiotics. She only takes antibiotics for what was needed. She was confused if her eyes get worse, if it was more difficult to blink or more blurry. She knew one of the things she looked at said a very strained side effect was Covid Eye or whatever after receiving the Pfizer Covid Vaccine, but it blurs vision and may clear up after a few days. If she goes to the doctor and he says this might be a side effect, she doesn't know that the doctor will do anything or know what to do. If better or worse the patient stated she will call Pfizer back to report. She does not know how many people got this batch of the Pfizer Covid Vaccine. The events did not require visit to the emergency room or the physician's office. The patient stated she thought she better call because she doesn't want other people getting the Pfizer Covid Vaccine if maybe it was off or the pharmacy was not handling the medication right. The outcome of the event 'arm started hurting worse than it did after the caller received the first dose' was recovered on 25May2021, of losing her vision and blurriness was not recovered, and of remaining events was unknown. No follow-up attempts are needed. No further information is expected.
43 2021-06-09 pain in extremity Left elbow pain shooting down to her hand medial and lateral epicondylitis
43 2021-06-10 muscle twitching, bell's palsy, facial paralysis BELLS PHALSY, PARTIAL FACE PARALYSIS, RIGHT EYE & LIP TWITCH
43 2021-06-10 pain in extremity, numbness pt states her left arm is red, hot and heavy. She has episodes of the pain and numbness in her fing... Read more
pt states her left arm is red, hot and heavy. She has episodes of the pain and numbness in her fingers that come and go. When this happens she gets a dry cough and has to clear her throat in order to have air to breath. She has had these symptoms a going on a couple of months now. Pt will wait for her new insurance to activate before she can schedule an appt with a doctor.
43 2021-06-12 flushing Pt came back after about 25 mins from injection stating she did not feel well. Symptoms included flu... Read more
Pt came back after about 25 mins from injection stating she did not feel well. Symptoms included flushing, nausea, and general not feeling well. When ask if she had symptoms like this before, pt said yes it is on and off. Patient admits that she feels like when she has not eaten. Pt admitted to not eating today before shot and it was likely due to that.
43 2021-06-12 numbness First dose of vaccine gave me allergy (throat closing) have to take allergy medicine and got better.... Read more
First dose of vaccine gave me allergy (throat closing) have to take allergy medicine and got better. Second dose: next day body aches and fatigue. A few days later started to have a bad headache and left shoulder pain. Left arm started to get numb, after left side of the face and last left leg. Blood pressure was high and went to ER were they kept me overnight to ensure I was not having a stroke.
43 2021-06-13 feeling of body temperature change, bell's palsy Fatigue, unable to stay awake x 3 days , felt hot and cold, severe body pain, lump r side of neck th... Read more
Fatigue, unable to stay awake x 3 days , felt hot and cold, severe body pain, lump r side of neck then lump under arm pit , Bells Palsy
43 2021-06-13 numbness, tingling About 2 min after my 2nd shot, I started feeling tingling in the left side of my neck, behind my ear... Read more
About 2 min after my 2nd shot, I started feeling tingling in the left side of my neck, behind my ear, and spreading through my face (tingling and numbness). Then, about 10 min later, I experienced very blurry vision. It's been six weeks and my vision has not recovered. While it's not as blurry as it was immediately following the vaccine, I now have consistent blurry vision within about two feet - which has resulted in me having headaches by the end of the day. I did not need glasses or contacts prior to the vaccine and had no issue with my vision.
43 2021-06-13 numbness, tingling 6-14-21 PT STATES SHE GOT COVID 19 VACCINE AND WITH IN 15 MIN HER LEGS FELT 'NUMB AND TINGLING'. SH... Read more
6-14-21 PT STATES SHE GOT COVID 19 VACCINE AND WITH IN 15 MIN HER LEGS FELT 'NUMB AND TINGLING'. SHE ALSO FELT DIZZY AND CHEST HURT X 5-6 DAYS'. SHE NOTIFIED STAFF AND ALSO HER PCP. SHE HAS APPT WITH HER PCP THE BEGINING OF JULY. INFORMED HER THAT REPORT WILL BE DONE AND SENT IN AND TO FOLLOW UP WITH PCP IF ANYMORE PROBLEMS.
43 2021-06-13 tingling Paresthesia and hypersensitivity to skin on L side of face/neck. No overlying rash. neuro exam gross... Read more
Paresthesia and hypersensitivity to skin on L side of face/neck. No overlying rash. neuro exam grossly intact
43 2021-06-13 tingling Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient immediately ... Read more
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient immediately described tingling in the left arm, from the site of injection to her fingers. Within the 15 minute waiting period, the patient further described tingling in both feet.
43 2021-06-15 muscle spasms 6/13 8:00am woke up with headache & full body ache. Lasted all day. 11:00pm mid back & chest pain (... Read more
6/13 8:00am woke up with headache & full body ache. Lasted all day. 11:00pm mid back & chest pain (spasms) 8/10 on pain scale. Took one ibuprofen and went to sleep at 12:00am. 2:30am woke up covered in sweat, nausea, chest pain 10/10 on pain scale. Went to ER. 3:15am EKG - bradycardia HR 42 bpm. Zofran & morphine given for pain/nausea. Labs drawn. CT Scan to r/o aortic dissection. Came back normal. Chest X-RAY completed. Mylanta given PO. Pain improved to a 4/10 during bradycardia episodes. HR still fluctuated between mid 60?s and low 40?s with correlating chest pain during bradycardia. 8:00am admitted to telemetry unit. EP consulted. Echo completed. Normal results. Bradycardia continued. Pain 0-2/10 on pain scale. 2:00pm discharged with Bradycardia continuing. Follow up with MD & EP.
43 2021-06-15 tingling, numbness Immediate strong soreness at injection site; sore enough that I spoke to the nurse doing the 15-minu... Read more
Immediate strong soreness at injection site; sore enough that I spoke to the nurse doing the 15-minute watch. She told me to monitor it and that soreness was a common result. My arm was sore but I also have some tingling and numbness in my left arm and hands. It is uncomfortable and worrying but does not seem to affect my activities at this point. That being said it has worsened over the period between now and the injection. My only side effect from the first injection was soreness the day after the injection, which subsided within two days with no lasting effects.
43 2021-06-16 numbness I started having headaches that were pretty intense and constant. It progressed between doses to hav... Read more
I started having headaches that were pretty intense and constant. It progressed between doses to having a headache everyday. I had swelling and joint pain, I went to the doctor for the ongoing headaches except for some OTC treatment. I got some blurriness and numbness in my left shoulder. My biggest concern was the constant headaches. I also saw my rheumatologist. He increased my acthar between shots to see if it would calm things.
43 2021-06-16 pain in extremity, migraine very sore arm 4-16 hours; fevers and chills 12-36 hours (max temp = 101.9); fevers and chills 12-36 ... Read more
very sore arm 4-16 hours; fevers and chills 12-36 hours (max temp = 101.9); fevers and chills 12-36 hours (max temp = 101.9); headache starting approx 19 hrs; insomnia 12-24 hrs; significant fatigue 24-48 hours and more mild fatigue 48-72 hours (the mild fatigue being more than my baseline constant fatigue); migraine; This is a spontaneous report from a contactable patient. A 43-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), intramuscular, administered in Arm Left on 21Jan2021 at 08:00 (Batch/Lot Number: EL3246) as 2nd dose, single dose for covid-19 immunization. Medical history included obese (BMI approx 30), seasonal allergies and breastfeeding.Concomitant medications included prenatal vitamins ,fexofenadine hydrochloride (ALLEGRA) and probiotics (PROBIOTICS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks of the vaccination. Post vaccination, the patient had not been tested for COVID. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), intramuscular, administered in Arm Left on 22Dec2020 at 13:00 (Batch/Lot Number: EH9899) as 1 st dose, single dose for covid-19 immunization and experienced mild-mod sore arm. In Jan2021, after the second dose, the patient had very sore arm 4-16 hours (reported this because more sore than other vaccines she had received, over all she was not concerned about sore arm though), fevers and chills 12-36 hours (max temp was equal to 101.9), headache started approx. 19 hours, insomnia 12-24 hours(unsure from vaccine or fevers/rigors themselves), significant fatigue 24-48 hours and more mild fatigue 48-72 hours (the mild fatigue being more than baseline constant fatigue) and intermittent headache (tension vs mild migraine) for 1week. It was unclear if was vaccine related vs normal fatigue/stress/weather. The patient underwent lab tests which included BMI: approx 30 and temperature: 101.9. The event fever and headache was treated with ibuprofen. The outcome of events was resolved in 2021. Follow-up attempts are completed. No further information is expected.
43 2021-06-16 pain in extremity I had soreness in my left arm I was not concerned about it. Within 24hrs the headaches became more i... Read more
I had soreness in my left arm I was not concerned about it. Within 24hrs the headaches became more intense. From that pint forward I have had a headache everyday. I have had double vision, blurred vision, dizziness and watery eyes. Depending on what side it is on, my pupil will be dilated on that side. The pain is so bad that I sometimes just want to lock myself in a dark room. I have went to multiple doctors. Bloodwork showed elevated ALT, but nothing was done. MRI of brain was done and showed some inflammation. About 2 weeks ago, I was diagnosed with cluster headaches and CNS lupus. I already have lupus so I am aware the vaccine did not directly cause this. I have started on anti seizure meds which has calmed things down a bit. The headaches are still around but not as debilitating as they were. After the vaccine, I did experience some joint pain and selling but they were not the biggest concern. I will be seeing the neurologist on Tuesday 6/22, I will be doing bloodwork. I was tested for antibodies but I have absolutely no antibodies. I was tested with my fiancé who received the vaccine on the same day. He was off the charts with antibodies. There has been some talk of receiving another shot but because of my reaction, I am not sure where we will go from here.
43 2021-06-16 pain in extremity breastfeeding currently; breastfeeding currently; Only mild-mod sore arm; This is a spontaneous repo... Read more
breastfeeding currently; breastfeeding currently; Only mild-mod sore arm; This is a spontaneous report from a contactable physician. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in Arm Left on 22Dec2020 13:00 (Batch/Lot Number: EH9899) as 1st dose, single dose for an unspecified indication. Medical history included Obese (BMI Approx 30), seasonal allergy. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient's other medications in two weeks includes Prenatal Vitamins, Allegra, Probiotics. Patient don't have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced breastfeeding currently on 22Dec2020 and only mild-mod sore arm on Dec2020.The patient underwent lab tests and procedures which included body mass index resulted in approx. 30 on unknown date. The outcome for events was unknown. Follow-up (07May2021): Follow-up attempts completed. No further information expected.
43 2021-06-16 tingling tachycardia; throat tightness; tingling lips and under tongue; itching face; This is a spontaneous r... Read more
tachycardia; throat tightness; tingling lips and under tongue; itching face; This is a spontaneous report from a contactable physician. This physician reported for a 43-year-old female patient. A 43-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine; Lot number: EN5318), intramuscular on 11Feb2021 09:30 as 2nd dose, single dose for covid-19 immunization. Medical history included hypothyroidism from an unknown date and ongoing.. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA), diphenhydramine hydrochloride (BENADRYL), levothyroxine (LEVOTHYROXINE). Allergies included Sulfa, iodine contrast media, latex, Levaquin, penicillin. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine; Lot number: unknown), via unspecified route on 21Jan2021 (at the age of 42-year-old) 1st dose, single dose for covid-19 immunization. On 11Feb2021 at 09:30, the patient experienced tachycardia, throat tightness, tingling lips and under tongue, itching face. Therapeutic measures were taken as a result of events of Benadryl, Pepcid, prednisone. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events were resolved in 2021. Follow-up attempts completed. No further information expected.
43 2021-06-17 breast pain, pain in extremity Her right arm is also hurting. Her right arm does not hurt all of the time, just sometimes.; but Fri... Read more
Her right arm is also hurting. Her right arm does not hurt all of the time, just sometimes.; but Friday morning she experienced right breast pain/Three to four days ago, her right breast began hurting; experienced right breast pain and her right breast feels "heavier" and "tighter" than her left and it feels like "lumps".; experienced right breast pain and her right breast feels "heavier" and "tighter" than her left and it feels like "lumps".; This is a spontaneous report received from a contactable consumer or other non-health care professional. This female consumer (patient) reported that a 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWO187), via an unspecified route of administration, administered in right arm (at the age of 43-years-old) on 28May2021 14:30 as 2nd dose, single dose for covid-19 immunisation. The patient's medical history was not reported. Her mother has breast cancer. The patient did not have history of previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect and no prior Vaccinations (within 4 weeks). The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: unknown, Lot number and Expiration date: EWO173), via an unspecified route of administration in arm right on 05May2021 14:30 as 1st dose, single dose for COVID-19 immunisation and had no reaction on previous exposure to vaccine. The patient reported that within the last 2 weeks, she began experiencing right arm pain and right breast pain. She reports that up until last Friday morning (11Jun2021), it was tolerable, but Friday morning she experienced right breast pain and her right breast feels "heavier" and "tighter" than her left and it feels like "lumps". Her right breast feels heavier than the left one. She says that she does not take medication of any kind and that the covid-19 vaccine is the first thing she's had in 10-12 years. She states that she will call her doctor but may not take anything if they prescribe it and will just wait and see if this will go away on its own. She also reported being able to see the difference in size. She reports she read online that these side effects are normal and is calling today to ask if these symptoms have been reported. Her right arm does not hurt all the time, just sometimes. She is asking if she should be concerned and see a doctor. Before she had her period, she felt heaviness in her right breast. It was not something she really noticed; it is there every month. But on Friday, 11Jun2021, she really noticed it. Her right breast felt heavier. It felt different while she was walking, and she was feeling heaviness on her right breast. The next day her right arm was not hurting, but today her arm is hurting hard. She has been trying to drink a lot of water and juice, hoping it will get better. She does not take medications. This is the first time she has taken any medication in 20 years. She states yesterday was a little better, but not much of a difference. There was a very little difference between today and yesterday. Her breast and arm hurt worse whenever she is walking. She is fine, she knows this is because of the vaccine. She is asking should she be concerned. She did not want it initially. Everyone was taking it. She was not sure if she was doing the right thing by not taking it. She works. She felt pressure from society and her family to take the covid vaccine. It took her a couple of weeks to decide if she should get it or not. She does not take medications. She was not sure if she should get the covid vaccine or not, and it was bothering her. The patient stated that she does not have any medical conditions to include. She does not have very good stamina. She gets tired easy. She is on a diet to maintain that. She is not a weak person; she goes on hikes. She must work on her balance. The patient was not recovered from the events.
43 2021-06-17 numbness, pain in extremity I received sharp chest pain in my upper chest on the left side and later the right side. I also sta... Read more
I received sharp chest pain in my upper chest on the left side and later the right side. I also started to have some dizzy spells when I would go to stand up suddenly. A couple of weeks later I received some numbness and soreness in both my legs. All of these pains would come and go regularly and started to subside over time. I did not think this was related to the shot at the time. I went to see my doctor after 2 weeks and she thought it was muscle related so I have been going to physio but they felt that these reactions were not related to normal muscle problems (especially the sharp chest pains). I am reporting now because I read about possible heart inflammation issues recently and thought maybe this may be related but I am not sure.
43 2021-06-17 pain in extremity Patient felt immediate pain/tingling upon injection. Has been sore the entire month and is difficul... Read more
Patient felt immediate pain/tingling upon injection. Has been sore the entire month and is difficult for her to use her arm.
43 2021-06-17 tingling sensation in her hands & toes like pens/needles; hives; This is a spontaneous report from a contacta... Read more
sensation in her hands & toes like pens/needles; hives; This is a spontaneous report from a contactable other HCP (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, in Arm Right on 19May2021 18:30 (Batch/Lot Number: EW0177) as single dose for covid-19 immunization. Medical history included thyroidectomy from 2005, gastrooesophageal reflux disease. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for thyroidectomy, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease, start and stop date were not reported. On 19May2021 21:30, patient experienced hives, treated with Benadryl, and on 24May2021, sensation in her hands & toes like pens/needles. Caller states she couldn't drive, her hands started to hurt with the pins and needles and they wouldn't go away, it was constant in her fingers and toes. Patient went to a neurologist, did have a neurological work-up and he suggested patient to visit a cardiologist Patient will have a cardiological work-up and probably will have to go to the rheumatologist after that. Outcome of event hives was recovered by the time she woke up the next day, of other events was not recovered. Information about lot/batch number was obtained. Additional information is requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
43 2021-06-18 pain in extremity On June 17th, after the injection I just had a sore arm which is typical. When I woke up around 8 am... Read more
On June 17th, after the injection I just had a sore arm which is typical. When I woke up around 8 am on Friday the 18th, I had full body muscle soreness and a headache. As the day went on, my headache got worse and felt really fatigued and tired. Still had the full body muscle soreness all day. By around 11:45 pm on the 18th, I was throwing up. I went to bed and woke up around 5 am on the 19th still with a headache. I took a migraine pill and some Advil and has since subsided so far and full body soreness is gone.
43 2021-06-20 feeling hot So after I get the vaccine, the day after I feel hotness and feverish but when I took temperature it... Read more
So after I get the vaccine, the day after I feel hotness and feverish but when I took temperature it was only 99. I feel tiredness and pain where the vaccine was. The next day was less symptoms, just tired and exhausted. The arm where I got the vaccine was pain and swelling for about a week. I took some Tylenol on the first day and that is about it.
43 2021-06-21 muscle spasms I did not experience anything until 12 hours later. Severe hard cramping in both of my legs and feet... Read more
I did not experience anything until 12 hours later. Severe hard cramping in both of my legs and feet while I was sleeping. The next day the fatigue was normal but the leg cramping is worse. I still have the leg cramping. I did an ultrasound for blood clotting and blood work. It was a week after the vaccine and you were still feeling it. The tiredness went away but the cramping is still present. It skipped a period and you have had a very inconsistent cycle. My period seems to be normal now but that was after the vaccine was administered.
43 2021-06-21 muscle spasms One hour after the vaccine I had headache, my feet were sweating, a little of wheezing and experienc... Read more
One hour after the vaccine I had headache, my feet were sweating, a little of wheezing and experienced fatigue. On day two my symptoms continue added nausea , cramping of my right toes and an upset stomach feeling started, also I started to feel dizzy. 6/11/21. The ER said to drink lots of fluids and sent me home. Today is day 14 and I am still sick with nausea and dizziness and anxiety. I went to my primary doctor on Thursday 6/17/21. My period arrived 10 days earlier with heavy discharge and small clots. My period ended yesterday. I am not able to drive, work or go out because I am dizzy. My body feels strange.
43 2021-06-22 flushing PATIENT COMPLAINED OF FEELING FLUSHED, ANXIOUS, AND SHAKY. PATIENT OBSERVED
43 2021-06-22 pain in extremity 3-36 hours after shot: sore arm; 20-36 hours after shot: slight headache; 30-48 hours after shot: sw... Read more
3-36 hours after shot: sore arm; 20-36 hours after shot: slight headache; 30-48 hours after shot: swollen lymph nodes & nasal drainage
43 2021-06-23 discomfort 1)Shingles developed on right side lower body 10 days after 2nd dose covid vaccine. First symptom w... Read more
1)Shingles developed on right side lower body 10 days after 2nd dose covid vaccine. First symptom was discomfort & mild pain. A week letter a rash emerged so I went to Dr & was diagnosed. It?s been 4 weeks & still recovering. 2) A second effect I?m beginning to notice is that my RA which has been under control for several years now through anti-inflammatory diet, is starting to act up. Pain in fingers - primarily pinky fingers with swelling at joints. Both hands. First time experiencing any symptoms on right hand. And I have never had the characteristic bumps at the joints until now. I haven?t yet mentioned this symptom to my dr. It I was overshadowed by the extreme pain from shingles.
43 2021-06-23 numbness, tingling About 45 minutes after the vaccine was given I developed numbness and tingling on the left side of m... Read more
About 45 minutes after the vaccine was given I developed numbness and tingling on the left side of my face, from my lower cheek to my eyebrow, including half of my nose. The symptoms started improving slowly a day later and were gone about 2-3 days later.
43 2021-06-23 tingling left fourth and fifth finger tingling at the time of the shot and persisted until now
43 2021-06-26 weakness Started with body aches, joint pain and weakness, followed by SOB that was aggravated over time- esp... Read more
Started with body aches, joint pain and weakness, followed by SOB that was aggravated over time- especially after the 2nd dose- Then, she started having increase heart palpitations and chest pressure. Eventually noted ischemic changes with purplish discoloration face, hands and feet. At this time it became great effort to walk due to lack of air- SOB was severe. She was taken to ER at hospital where she was admitted with possible PE, MI or heart failure. After few days no improvement was achieved and patient trans ported to another Hospital to receive more advance care but she was pronounced death in the morning of 5-11-21. The death certificate heart failure as immediate cause of death, preceded by PE and pulmonary hypertension.
43 2021-06-27 migraine with aura Migraines with aura, extreme restlessness in the evenings preventing sleep
43 2021-06-27 pain in extremity The day of the vaccine, I had a sore arm and kind of a sore wrist on the right side. The next mornin... Read more
The day of the vaccine, I had a sore arm and kind of a sore wrist on the right side. The next morning, I felt fine and put some laundry away and I immediately had to take a nap. Tired and took a lot of naps. I didn't have a high fever, my husband said I was a bit warm but no full on fever. I slept a lot on that Tuesday. After that, in the following days, I did notice I had a hard time concentrating and that lasted in all the following weeks. I felt like my energy was back but I couldn't concentrate and I felt really foggy and mind was unfocused. That is still occurring but less so. I mentioned this to my doctor. It's similar symptoms to when I'm having an auto-immune flair. I hadn't changed my diet or stopped taking my medicine but it felt like a flair-up. My doctor said I could come in to check my thyroid if I wanted to. Haven't yet but have just been diligent at taking my vitamins and meds really well so I'm trying to see if that works. I have a family friend who is a naturopath, that recommended how to get my inflammation down. She had me increase VIT D and drink more water and not eat anything that causes inflammation, no bread, pasta, nuts and dairy and she has me taking a microbiome probiotic.
43 2021-06-27 seizure The day of the vaccine I felt really tired after a few hours. I normally have low grade fevers so I ... Read more
The day of the vaccine I felt really tired after a few hours. I normally have low grade fevers so I was not concerned with that. During the night I woke up and I passed out and had some symptoms of seizure when I got up. I am still experiencing symptoms and it has been twelve weeks and my heart rate is high. I continued having a high fever for two weeks, it was running at 102-103 degrees instead of my normal low grade fever at times 99-100 degrees. My heart rate was also very high exaggerated heart rate since getting the vaccine Even if I do normal activity I feel palpitations and my heart rate is elevated. My blood Pressure had been elevated and I have been experiencing dizziness. Some tests are showing leaky valves and PVCs. I have experienced chest pain which is recently resolved. I feel tired and dizzy. At one time the backs of my hands turned blue for a few days. I was unable to work for the first month after the second dose of the vaccine. I have been working but I am still very tired and I have used all of my time off. I have seen a Cardiologist, Neurologist.
43 2021-06-28 pain in extremity Sore arm starting 3 hours after shot and continuing into next day.
43 2021-06-29 feeling hot quite dizzy and loopy; she was quite pale; feeling to being high or drunk; feeling to being high or ... Read more
quite dizzy and loopy; she was quite pale; feeling to being high or drunk; feeling to being high or drunk; almost fell over the coffee table; notes a warm sensation; slept for many hours; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 02Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Feb2021, after receiving her first dose of Pfizer-Biontech Covid19 vaccine last Tuesday patient experienced a severe reaction. She waited in her car for 15 minutes after administration, then notes a warm sensation when she started driving away, states she drove home on autopilot not sure how she made it home. Upon arriving at home, she noted she was quite dizzy and loopy, almost fell over the coffee table, her husband told her she was quite pale, and she equates the feeling to being high or drunk. She stated that she went to bed, slept for many hours, and when she woke up, she felt a lot better and asked is this a severe reaction and what should she do about the second dose. The clinical outcome of all the events was resolving. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected. Question: Caller is a consumer reporting AE's after receiving her first dose of Pfizer-Biontech Covid19 vaccine last Tuesday, 02Feb2021. She believes she had a severe reaction. She waited in her car for 15 minutes after administration, then notes a warm sensation when she started driving away, states she drove home "on autopilot" -not sure how she made it home. Upon arriving at home she noted she was quite dizzy and "loopy", almost fell over the coffee table, her husband told her she was quite pale, and she equates the feeling to being high or drunk. She state she went to bed, slept for many hours, and when she woke up she felt a lot better. Is this a severe reaction? What should she do about the second dose? Call Details: Callback to (phone number withheld); (name withheld) 43 y/o Had the Pfizer first dose last Tuesday 02Feb2021 at a college in (place name withheld) Questions about the second dose- Severe Reaction? Waited in the car 15 minutes - warm sensation and then as I started driving away, I was on autopilot and felt stoned-ish- not right - dizzy/loopy almost fell over the coffee table. slept it off and had my husband check on me- when I woke up I felt better Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
43 2021-06-29 numbness numbness- shoulders, chest, arms, upper back, hands, fingers; joint pain- shoulders, elbows, ankles;... Read more
numbness- shoulders, chest, arms, upper back, hands, fingers; joint pain- shoulders, elbows, ankles; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no: EW0182) via unspecified route, administered in right arm, as dose 1 single on 06May2021 at 15:30 (at the age of 43-years) for COVID-19 immunization. The most recent COVID-19 vaccine was administered in pharmacy or drug store. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09May2021 10:00, the patient experienced joint pain- shoulders, elbows, ankles and numbness- shoulders, chest, arms, upper back, hands, fingers. The patient received treatment for the events which included steroids, muscle relaxers, therapy and chiropractor. The clinical outcome of the joint pain- shoulders, elbows, ankles and numbness- shoulders, chest, arms, upper back, hands, fingers were not recovered. Information on batch/lot no. are available. Further information has been requested.
43 2021-06-29 pain in extremity First day 1 .Arm pain 2.Neck pain 3.headache Second day 4.chest Pain 5.Armpit pain 6.strong p... Read more
First day 1 .Arm pain 2.Neck pain 3.headache Second day 4.chest Pain 5.Armpit pain 6.strong pain in the arm 7. some difficulty to breath 8. Swelling face The rest of the days until today 6/30/2021 Armpit pain chest pain chest pressure some difficult to breath leg and feet pain
43 2021-06-30 slurring, tremor, tingling, feeling cold Pt experienced cold sweats, tremors, confusion, tingling sensation, slurred speech, and LOC with pos... Read more
Pt experienced cold sweats, tremors, confusion, tingling sensation, slurred speech, and LOC with post-episode exhaustion. This episode occurred 12-24 hours after the first dose (4/19/21) and the second dose (5/10/21).
43 2021-07-01 hot flush Tired; Pain in injection site; Chills; Dizziness; Headache; Runny nose; Hot flashes; Acne; Increase ... Read more
Tired; Pain in injection site; Chills; Dizziness; Headache; Runny nose; Hot flashes; Acne; Increase sense of smell; Pain in lungs when breathing; Racing heart; Vertigo; Tinnitus; Joint pain; Cough; Stuffy nose; Blurry vision; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 19Mar2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease and hypothyroid. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received medications within 2 weeks of vaccination included lisinopril (MANUFACTURER UNKNOWN), PAXIL, CLARITIN and SYNTHROID, all for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 1400, the patient was tired and had experienced pain in injection site, chills, dizziness, headache, runny nose, hot flashes, acne, increase sense of smell, pain in lungs, when breathing, racing heart, vertigo, tinnitus, joint pain, cough, stuffy nose, blurry vision and anxiety. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tired, pain in injection site, chills, dizziness, headache, runny nose, hot flashes, acne, increase sense of smell, pain in lungs, when breathing, racing heart, vertigo, tinnitus, joint pain, cough, stuffy nose, blurry vision and anxiety were resolving at the time of this report. Information on lot/batch number has been requested. No further information is expected.
43 2021-07-01 numbness numbness in shoulder up into clavicle and neck/ numbness spread into the left side of my face; I bec... Read more
numbness in shoulder up into clavicle and neck/ numbness spread into the left side of my face; I became extremely tired about 2 hours after the shot; pain started in injection site/ could not lift my arm at all; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 0155238-18053) via an unspecified route of administration on 11Mar2021 at 15:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme since 1996 and chronic lyme but not have had a flare in 3 years. The patient had allergies to nickel, latex and almonds. The concomitant medications included biotin (MANUFACTURER UNKNOWN), omega 3 (MANUFACTURER UNKNOWN) and collagen (MANUFACTURER UNKNOWN). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID19. On 11Mar2021 at 16:00, the patient experienced extreme numbness in shoulder up into clavicle and neck within 15 minutes and the numbness spreaded into the left side of the face as if she was giving Novacane. The patient became extremely tired about 2 hours after the shot and pain started in injection site and by the next morning, she could not lift her arm at all. The patient did not receive any treatment for reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events numbness, tiredness and injection site pain were recovered on an unknown date of Mar2021. No follow-up attempts are needed. No further information is expected.
43 2021-07-02 pain in extremity, feeling hot Left arm started to heat up like fire up hot sunburn hot to neck and right arm; Panic attack; Arm a ... Read more
Left arm started to heat up like fire up hot sunburn hot to neck and right arm; Panic attack; Arm a bit sore; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route administration in the left arm on 24Mar2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included leukaemia (childhood in remission). The patient had no known allergies. Concomitant mediation included norethindrone; ethinyl estradiol (MICROGESTIN), esomeprazole (MANUFACTURER UNKNOWN), omega3 (MANUFACTURER UNKNOWN) and turmeric all drugs started on an unknown date for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 24Mar2021 at 12:00 (minutes after the injection), the patient's whole left arm started to heat up like fire up hot, sunburn hot. No spots no rashes were present, it continued to travel over neck to right arm which was not as severe, but also not amazing. After about 10 minutes and a panic attack later it was gone. The patient felt completely fine but reported to have had a sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events left arm started to heat up like fire up hot sunburn hot to neck and right arm and panic attack was resolved on 24Mar2021. The clinical outcome of the event arm a bit sore was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
43 2021-07-04 burning sensation facial breakout/allergic skin reaction very painful burning sensation on face bruising and "crusty" ... Read more
facial breakout/allergic skin reaction very painful burning sensation on face bruising and "crusty" feeling on face raised bumps that are not quite bumps and not quite hives
43 2021-07-05 pain in extremity, hypersensitivity of all senses My heart feel like it keeps clinching up/my heart it feeling like CVF I don't know how to describe i... Read more
My heart feel like it keeps clinching up/my heart it feeling like CVF I don't know how to describe it; My arm is like really hurt; It start like chest got vibration something then it go away ,it did not happen again, then it did happen may be 3-4 times a week; Its extreme skin sensitivity specially under my arm; It hurts to touch the skin specially while the shower when warm water hits; I had some mild skin irritation with first one and with 2nd one it got more intense like skin extreme sensitivity; It hurts to touch the skin specially while the shower when warm water hits; This is a spontaneous report from a contactable consumer (patient herself). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EJ1686), via intramuscular route, administered in left arm on 04Feb2021 (age at vaccination: 43 years) as dose 1, single; via intramuscular route, administered in right arm on 24Feb2021 (Batch/Lot Number: EJ1686) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was none. Concomitant medication(s) included vitamins nos. The patient did not have any heart problem. The patient did not receive any vaccine in 4 weeks. On an unknown date, the patient's heart felt like it keeps clinching up/her heart it is feeling like cvf she doesn't know how to describe it. On 25May2021, she had some mild skin irritation with first one and with 2nd one it got more intense like skin extreme sensitivity, Patient had some mild skin adverse reactions when she received the 1st shot, when she received the 2nd it got worse I was told at the time when given you know 3-4 weeks is usually everybody those who have one more reaction in 2-4 weeks usually go away, and I was administered at work which I work as health care worker and it was given by (withheld), she still can not have any, its extreme skin sensitivity specially under my arm, like it hurts to touch the skin specially while the shower when warm water hits it and my heart it feeling like CVF I do not know how to describe it, and this thing she got after the shot she was wondering because she was reading all the stuff online and a lot of people have it but it does not say like a time framing when I can expect it to go away. Is there is any time framing for most people for side effect go away. because my heart feel like it keeps clinching up and my arm is like really hurt." Well it start like chest got vibration something then it go away, it did not happen again, then it did happen may be 3-4 times a week , then once a week and then it was like 2-3 times a week then, I talked with (withheld), because they are one that gave us shot and they first said I was like anywhere like 2 week to a months the symptoms will go away, you know and they have away it has been like 4 months now and so just want to find out how many of people still are not went away. "Its like it was not like a major start of, It kept being like progressive worsen then better you know what I mean from skin to then they move to (Incomplete sentence) its sensitivity. Patient received treatment included Just topicals, I have using just topicals nothing else. The event of Cardiac disorder was considered to be medically significant. On an unknown date in Sep2020 and Jan2021, the patient underwent unspecified lab tests with unknown results. The outcome of cardiac disorder, condition aggravated, chest discomfort, limb injury was unknown, and it was not recovered for all the other events. Information on lot/batch number was available. Additional information has been requested. Follow-Up 23JUN2021: Follow-up attempts are completed. No further information is expected.
43 2021-07-05 pain in extremity - Constant thirst **I hadn't read about this anywhere as a side effect so felt like I should report ... Read more
- Constant thirst **I hadn't read about this anywhere as a side effect so felt like I should report it. I am certain its related to vaccine because I don't ever experience this and there isn't anything else unusual about my last few days that would have made my mouth dry and feeling thirsty all day - Arm pain increasing throughout the day - very sore, moves into shoulder blade
43 2021-07-05 pain in extremity Sore Arm. Started about 5 hours after injection.; This is a spontaneous report from a non-contactabl... Read more
Sore Arm. Started about 5 hours after injection.; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other medication within two weeks prior to the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, the patient experienced sore arm started about 5 hours after injection. The clinical outcome of the sore arm started about 5 hours after injection was not recovered. Amendment: This follow up is being submitted to amend previously reported information: State leave blank for reporter and patient since no state provided in source. Final sentence updated to No follow-up attempts are possible. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
43 2021-07-05 pain in extremity Deafness; can't hear well; have pain; I can't sleep well; pain on her ears; ringing in the ear; Pain... Read more
Deafness; can't hear well; have pain; I can't sleep well; pain on her ears; ringing in the ear; Pain in arm; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the second dose of BNT162b2 (Pfizer BioNTech Covid vaccine, lot number ER8736) via unspecified route of administration on 17May2021, at patient age of 43-year-old, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as no. The patient previously received the first dose of BNT162b2 (Pfizer BioNTech Covid vaccine, lot number ER8731) via unspecified route of administration on 26Apr2021, at patient age of 43-year-old, as a single dose for COVID-19 immunisation. The patient had her 2nd shot of the Pfizer BioNTech Covid vaccine on 17May2021 and 2 days later she had some pain in her arm that lasted 1 day and then resolved. The patient had bilateral hearing loss and also pain on her ears that had not gone away. The patient can't tolerate it and was wondering if this was caused by the vaccine. The patient also had this buzzing in her ears and she had this conversation with a child that had the vaccine and had the same symptoms. The patient had dull sound in her ear during that period, a problem with her ears and it has not gone away. The patient stated she still had it and was also not able to speak directly with the phone close to her ear and was speaking with the phone on speaker, if not her ears hurt. The patient stated the day following, she had the vaccine in the afternoon and had no pain in her arm or her ears, she woke up with the pain in her ears and her arm.The patient was being seen at a health center. The patient stated her arm started hurting the next morning, her left one that is where she had the vaccine in that arm. The patient stated it lasted for 1 day and didn't go away completely, that she had a lot of pain and wasn't able to calm herself and the next day was better. The patient stated she did not have the arm pain anymore. It started on 17May2021 and last 18May2021 and part of 19May2021 in the morning and then went away. The patient stated the problem with her ears since the vaccine started the next morning and the 1st day she had no pain and then started with a little deafness and she wasn't able to hear well. The patient stated the next day she had deafness and buzzing up until today (21Jun2021) and she still had pain and deafness and was not able to speak over the phone as it causes her pain and in the night she had pain and buzzing and she doesn't sleep well. The patient stated on 01Jul2021 she was scheduled for her physical but has not been seen for this by her provider. The patient had been taking ibuprofen for her ears, not for the arm pain she didn't take anything while she had that. The patient stated she has been taking it just for some days to calm the discomfort and she has a daughter to attend to the whole day and someone suggested to her to take that for pain and she has been taking it for a week and a half. The patient wanted to know if this is going to be permanent or if it will go away and is concerned if it is going to be permanent. The outcome of the events pain, pain in arm was resolved. The outcome of events can't hear well, pain on her ears, ringing in the ear, Deafness was not resolved. The outcome of the other events was unknown.
43 2021-07-06 pain in extremity The day of I had sore arm, next day arm was more sore and started having toothache and sinus pressur... Read more
The day of I had sore arm, next day arm was more sore and started having toothache and sinus pressure. Saturday arm relieved, sinus was worse, swelling in my face, went to urgent care and got antibiotics and painkillers, Sunday I developed an abscess. Went to dentist today and they had to cut it open and drain it, will need root canal.
43 2021-07-08 weakness Severe chills; shivering; body aches; headache; Weakness; fatigue; Nausea; This is a spontaneous rep... Read more
Severe chills; shivering; body aches; headache; Weakness; fatigue; Nausea; This is a spontaneous report received from a non-contactable consumer, the patient. A 43-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included thalassemia. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and ibuprofen (ADVIL); both from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04Mar2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation and shrimp on unknown date and experienced an seafood allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 02:00, the patient experienced severe chills, shivering, body aches, headache, weakness, fatigue and nausea. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the severe chills, shivering, body aches, headache, weakness, fatigue and nausea was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
43 2021-07-08 feeling hot About 2 hours after vaccination started with rash on the right side of cheek and neck. Then started ... Read more
About 2 hours after vaccination started with rash on the right side of cheek and neck. Then started with hot sensation all over the upper body and difficulty breathing. Worsening of post nasal drainage. She have herself an epi-pen injection. Continued to have difficulty breathing and went to the ER for evaluation.
43 2021-07-08 flushing Pt w/ hx of codeine allergy (Rash). Pt c/o flushing/sweating and nausea 15mins after vaccination. BP... Read more
Pt w/ hx of codeine allergy (Rash). Pt c/o flushing/sweating and nausea 15mins after vaccination. BP 129/80, HR 77, O2Sat 100% RA -- > 133/85, 70. Pt stable and released from vaccination site 1hr 10mins post vaccination.
43 2021-07-08 pain in extremity, discomfort Left chest pain and pressure, extending into left arm, back and into jaw line. Shortness of breath,... Read more
Left chest pain and pressure, extending into left arm, back and into jaw line. Shortness of breath, non productive cough, nausea and vomiting. Symptoms worsen when laying flat or of up walking around. Swollen feet and legs. Still experiencing systems. Completed course of antibiotics, predniSONE 20 MG tablet, and toradol. Currently resuming Motrin 3x a day, albuterol sulfate 90 mcg inhaler, Pulmicort Flexhaler 180 mcg/actuation inhaler, ondansetron ODT 4 MG disintegrating tablet, benzonatate 100 MG capsule
43 2021-07-08 tingling After my 2nd shot I had tingling in my thumb; This is a spontaneous report from a contactable consum... Read more
After my 2nd shot I had tingling in my thumb; This is a spontaneous report from a contactable consumer (reporting herself). This 43-Year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration in right arm on 03Feb2021 at 10:00 (age at the time of vaccination was 43 years old) as single dose for COVID-19 immunization. The patient's medical history included asthma. The patient had unspecified allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks of COVID vaccination. The patient did not experience COVID-19 prior to vaccination. The patient received other unspecified medication in two weeks of vaccination. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL0142), via an unspecified route of administration in right arm on 13Jan2021 at 10:00 as single dose for COVID-19 immunization. On 03Feb2021 at 10:00, After the second shot, the patient had tingling in her thumb and on her first two fingers (like finger fell asleep) and had very little feeling. This was lasted about for 2 and half hours. The patient did not received any treatment for the event. On 26Feb2021, the patient tested negative for COVID test. On 04Mar2021, the patient again tested for COVID and the result was pending. The outcome of the event was resolved. No follow-ups are possible. No further information is required.
43 2021-07-10 pain in extremity DVT - blood clot, found in left leg. Symptom, leg pain, diagnosed via ultrasound at hospital , Lov... Read more
DVT - blood clot, found in left leg. Symptom, leg pain, diagnosed via ultrasound at hospital , Lovenox and Pradaxa
43 2021-07-11 numbness, discomfort, tingling May: tingly/pins-and-needles in hands June: loss of feeling/numbness in left lower leg; quickly foll... Read more
May: tingly/pins-and-needles in hands June: loss of feeling/numbness in left lower leg; quickly followed by acute weakness and loss of feeling/mobility in right leg and both hands and forearms
43 2021-07-11 pain in extremity, muscle spasms Patient report that after 20 mins of the vaccine she had a serve headache and nausea...next day felt... Read more
Patient report that after 20 mins of the vaccine she had a serve headache and nausea...next day felt pain all over her chest and arm and develop lumps under her breast and on her left arm... bad cramping, light headed and dizzy, heart was racing, chills and sweats
43 2021-07-12 discomfort, pain in extremity, slurring Sharp pain in left hand/Feet swollen and in pain; Slurred speech eyes dilated; Body heavy and in pai... Read more
Sharp pain in left hand/Feet swollen and in pain; Slurred speech eyes dilated; Body heavy and in pain; Body heavy and in pain; Throat feels like it's closing up; I can feel my heart beating and like their are ants in my veins.; Felt like arms swollen/Feet swollen and in pain; My vision is now blurred and reduced significantly; My vision is now blurred and reduced significantly; Severe panic attacks; Slurred speech eyes dilated; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; 43-year and non pregnant at the time of vaccination), first dose via an unspecified route of administration, in arm left on 20Mar2021 11:00 (Batch/Lot Number: EN6204; Expiration Date: Jun2021) at unknown dose single for covid-19 immunisation. Medical history included Hashimoto's Thyroiditis; Metronidazole Allergy. Concomitant medication included levothyroxine at 25 ug. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination was Levothyroxine 25 ug. On 20Mar2021 11:30, patient had "I have chronic disease, Hashimoto's thyroiditis. Severe reaction, sharp pain in left hand, 20 mins later slurred speech eyes dilated, body heavy and in pain, throat feels like it's closing up. I can feel my heart beating and like theirare ants in my veins. Felt like arms swollen. Feet swollen and in pain. Took antihistamine Benadryl. Doctors at Urgent care said I'm not having anaphylaxis but having severe panic attacks. Given steroid injection. Swelling reduced, pain reduced. I was able to see again although my vision is now blurred and reduced significantly ". Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, covid test post vaccination: covid test type post vaccination=Other, covid test date=08Jun2021, covid test result=Negative. The outcome of the events was resolved with sequel.
43 2021-07-12 feeling cold So, I had flue like symptoms chills, body, sweats, join, paint, headaches, nausea and fatigue like c... Read more
So, I had flue like symptoms chills, body, sweats, join, paint, headaches, nausea and fatigue like crazy. Like feeling overall awful and that was the start as soon as I got it within the next 48 hours. The issue I've had since then that sent me to the UC was that I felt like I had a left ear infection. My left ear hurt which was on the same side that I had my shot on. Throbbing and painful and clogged left ear. I felt like I had an ear infection. A few days after that I found right behind my ear, I had a big swelling lymph node and that was before 07/01 and it is still there. I also have a large lymph node under my left armpit. They've swollen and they're painful and that's ultimately why I went in because I was feeling sick with a lot of fatigue and not feeling good. Because of the ear and lymph nodes behind the ear I wanted to make sure nothing was wrong. When I went to the UC I let them know that I didn't know if it was because of the vaccine. They tested and said I had some kind of infection and they put me on Augmentin it was a 10-day dose twice a day and that's what I began to become allergic to since I was prescribed that. I've had every side effect from Augmentin that you can have. I've had extreme diarrhea, bloating, stomach cramps, joint pains, nausea, lack of appetite and lack of sleep. As of yesterday, the doctor said, "oh yeah you're having reaction to that", and she switched me to Keflex 4 times a day for 10 days. Six days after my follow, my white blood cell count actually went up. Even though I was on antibiotics my infection increased instead of getting better.
43 2021-07-12 night sweats, hot flush Hot flashes & night sweats started 6/11 and continued 7/1 25-30 a day. Was suppose to start period ... Read more
Hot flashes & night sweats started 6/11 and continued 7/1 25-30 a day. Was suppose to start period 6/11. (Last period start date was May 15) never started in June. Went to family doctor 7/7 she ran blood work. Received my blood work back with a call that my Follicle Stimulating Hormone was 27.7 and that I was on menopause. The next day after receiving the call I started.
43 2021-07-12 pain in extremity, tremor pain and swelling in myarmpit; hungry; developed fever, went up to 103.5, and only went down to 102 ... Read more
pain and swelling in myarmpit; hungry; developed fever, went up to 103.5, and only went down to 102 on 2 extra strength Tylenol; extreme chills; shaking; nausea for about 2 hours; I begin to get tired.; have A headache; sore arm at the injection site; no appetite through the whole 2nd day; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 at 08:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had reported shellfish and gluten allergy. Concomitant medications included lamotrigine 150 (M4ANUFACTURER UNKNOWN), lithium 150 (MANUFACTURER UNKNOWN) and famotidine 20 (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203) via an unspecified route of administration in the left arm on 05Mar2021 at 08:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the COVID-19 vaccine. On 26Mar2021 at 14:15 (7 hours after vaccine), the patient experienced tired, headache (severe headache), sore arm, extreme chills and shaking (for about 8 hours) and nausea (for about 2 hours). At 20:15 (around 12 hours), the patient had fever went up to 103.5 (unspecified unit) (fever for about 8 hours), and only went down to 102. The through whole second day (27Mar2021), after fever broke the patient was tired and had a mild headache and no appetite. On 28Mar2021 (48 hours after vaccination), the patient awoke with pain and swelling in her armpit, but hungry. The patient still has arm soreness at the injection site. The pain and swelling in her armpit were very uncomfortable. The patient still tired but other than the arm, armpit and tiredness, was ok. Therapeutic measure was taken as result of event fever and included the treatment with 2 extra strengths of paracetamol (TYLENOL) and the fever went down to 102 (unspecified unit), for other events no treatment was given. The clinical outcome of event nausea was resolved on 26Mar2021 at 17:00 (for about 2 hours) and for events chills and shaking were resolved on 26Mar2021 at 23:00 (for about 8 hours); whereas for events tiredness, headache, vaccination site pain, fever, decreased appetite, armpit pain and hunger were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
43 2021-07-14 pain in extremity Patient said she began experiencing some leg pains after the first dose of the Pfizer COVID-19 vacci... Read more
Patient said she began experiencing some leg pains after the first dose of the Pfizer COVID-19 vaccine. She said she thought it was something that was going to go away but has persisted even after getting the second dose. Rph informed patient to talk to her doctor about this issue.
43 2021-07-14 tingling Site: Pain at Injection Site-Severe, Systemic: Fever-Medium, Error: Shoulder Joint Injury (prolonged... Read more
Site: Pain at Injection Site-Severe, Systemic: Fever-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
43 2021-07-15 nerve pain 20 minutes after vaccination my throat felt tight and my tongue felt large. Benadryl taken before va... Read more
20 minutes after vaccination my throat felt tight and my tongue felt large. Benadryl taken before vaccination helped that subside. 12 hours: menstrual spotting, pain at injection site, fatigue, nerve pain on both sides of my chest, lymph node swelling on the left side of my chest and my left breast. I was vaccinated in my right arm. 4 days: left elbow swelling 7 days: rash under my right arm near the vaccination site 21 days: left elbow still swollen I participated in V-safe and I was asked to submit this form.
43 2021-07-17 burning sensation, electric shock sensation Small and bigger blisters form; The small ones scab pretty quick; The bigger ones burn and hurt if t... Read more
Small and bigger blisters form; The small ones scab pretty quick; The bigger ones burn and hurt if touched; The bigger ones burn and hurt if touched; Areas where its scratched constantly turn red, then brown. it looks like a bruise then it turns black; Areas where it's scratched constantly turn red, then brown. it looks like a bruise then it turns black; feels like it's running through my blood; I have currents of shocks all over my body; Itchiness all over my body; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received bnt162b2 (formulation: solution for injection, Lot number: Batch/Lot Number: GP7533), dose 1 via an unspecified route of administration, administered in left arm (at the age of 43-years) on 16Mar2021 17:30 as dose 1, single for covid-19 immunisation. Medical history included back legs, hips, and chronic migraines from an unknown date and unknown if ongoing. The patient had no known allergies. The patient's concomitant medications were not reported. On 31Mar2021 at 13:00 patient experienced itchiness all over her body. Small and bigger blisters form. The small ones scab pretty quick. The bigger ones burn and hurt if touched. Areas where it's scratched constantly turn red, then brown it looks like a bruise then it turns black. It felt like a mosquito bite where she first feels the sting and then the itchiness. She had currents of shocks all over her body. And it also felt like it's running through her blood. Adverse events resulted in doctor or other healthcare professional office, clinic visit and Emergency room, department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Patient had received her dose 2, single bnt162b2 (Lot number: Batch/Lot Number: ER2613) on 06Apr2021 at 5:30 PM into the left arm. The patient underwent lab test which includes nasal swab (expedited RT-PCR COVID-19 test) on 21Jun2021, and it was negative. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of all the events with pills for itchiness and allergy and scabies treatment. The outcome of all the events was not recovered.
43 2021-07-17 pain in extremity Neck stiff; Left armpit area swollen; Armpit area tender; Heart beat a couple of times felt veryrapi... Read more
Neck stiff; Left armpit area swollen; Armpit area tender; Heart beat a couple of times felt veryrapid; Neck sore; Itchy throat; Wheezing; Aches, hit by a truck feeling; Sweats; Sore left arm; Headache; Nausea; This is a spontaneous report from contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E86955 or EP6955) via an unspecified route of administration in the left arm on 28Mar2021 at 12:45 (at the age of 43-years-old) as a single dose, for COVID-19 immunisation. Medical history included asthma and body mass index (BMI). The patient did not have any allergies to medications, food, or other products. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) on occasion for an unknown indication from an unknown date. The patient did not receive any other vaccine within four weeks of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the left arm on 07Mar2021 at 15:30 (at the age of 43-years-old) as single dose, for COVID-19 immunisation. On 28Mar2021 at 17:30 (also reported as night of second dose), the patient experienced sore left arm, itchy throat, wheezing (needed to use inhaler), headache, sweats, nausea, aches, hit by a truck feeling which lasted until end of day on 29Mar2021. On 30Mar2021, the patient felt better but her neck was stiff and sore and left armpit area swollen and tender and heart beat a couple of times felt very rapid. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events of pain in arm, itchy throat, wheezing, headache, sweaty, nausea, pain, neck stiff, neck pain, local swelling, armpit pain and heart rate high was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
43 2021-07-17 tingling Burning/tingling sensation on skin around mouth; Burning/tingling sensation on skinaround mouth; Tin... Read more
Burning/tingling sensation on skin around mouth; Burning/tingling sensation on skinaround mouth; Tingling sensation in legs ankles and feet; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to maple. Concomitant medications included cefalexin (CEPHALEXIN) at a dose of 500 mg twice daily from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 20:15, the patient experienced tingling sensation in legs, ankles and feet and burning/tingling sensation on skin around mouth. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events tingling sensation in legs, ankles and feet and burning/tingling sensation on skin around mouth. The clinical outcomes of the events tingling sensation in legs, ankles and feet and burning/tingling sensation on skin around mouth were unknown at the time of the report. No follow-up attempts are needed. No further information is expected.
43 2021-07-17 tingling mild nausea; Fatigue; diffuse myalgia; Arthralgia; T 37.5; Palpitations; Tingling in feet and hands;... Read more
mild nausea; Fatigue; diffuse myalgia; Arthralgia; T 37.5; Palpitations; Tingling in feet and hands; mild lightheadedness; headache; This is a spontaneous report received from a contactable other healthcare professional (patient). A 43-year-old female patient received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot Number: EL3249), intramuscular, administered in arm left on 09Feb2021 12:15 as dose 1, single for covid-19 immunisation. Medical history included ongoing headache, GI discomfort from NSAIDs, possibly gluten. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks, did not experienced covid prior and post vaccination. On 09Feb2021 12:45 (after 30 min after injection), the patient experienced tingling in feet and hands, mild lightheadedness, headache, on 09Feb2021 20:15 (after 8 hrs after injection), the patient experienced palpitations, on 10Feb2021 00:15 (12 hrs after injection), the patient experienced mild nausea, fatigue, diffuse myalgia, arthralgia, temp 37.5. On 10Feb2021, the patient underwent lab tests which included body temperature: 37.5. Therapeutic measures were taken as a result of temperature 37.5 (body temperature abnormal). The clinical outcome of the tingling in feet and hands, mild lightheadedness, palpitations, mild nausea, fatigue, diffuse myalgia, arthralgia was unknown and of the headache, temp 37.5 was not recovered.
43 2021-07-17 tenderness tenderness in underarm (left side); This is a spontaneous report from a non-contactable consumer, th... Read more
tenderness in underarm (left side); This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history not reported. Concomitant medication included unspecified medication birth control (MANUFACTURER UNKNOWN) on an unknown start date received within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 05Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced tenderness in underarm (left side), the patient thought it could possibly be a lymph node. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tenderness in underarm (left side) was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
43 2021-07-18 numbness Numbness to mouth and bilateral legs, dizziness, crushing headache, generalized body pain
43 2021-07-19 feeling cold, facial pain, feeling hot I woke at 2:30 AM the day after my shot (so 7/18/21) with chills, a fever of 101.3, and body aches i... Read more
I woke at 2:30 AM the day after my shot (so 7/18/21) with chills, a fever of 101.3, and body aches in my joints, teeth, and face. I was unable to sleep through it. Around 10AM, I took 400mg of ibuprofen and was able to sleep for a bit. I woke around noon feeling hot. I basically bounced from being too hot to being too cold all day, in and out of sleep, from here. At 8 PM, the left side of my upper chest started to hurt and I discovered a lump between my armpit and left breast. I determined this to be enlarged lymph nodes. It was very difficult to sleep that night due to this soreness (I can best describe that it felt like a bruised rib). The next morning, (so 7/19/21),
43 2021-07-19 migraine, tingling Brain Fog, Migraines, pain at base of skull and neck, Vertigo, anxiety, depression, tingles in neck ... Read more
Brain Fog, Migraines, pain at base of skull and neck, Vertigo, anxiety, depression, tingles in neck and arm, vision loss and spots in eyes.
43 2021-07-19 pain in extremity, weakness feeling weak; headache; Arm pain; This is a spontaneous report from a contactable consumer, the pati... Read more
feeling weak; headache; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the arm left on 30Mar2021 at 13:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included single functional kidney. The patient had known allergies to epinephrine and lobster. The patient did not receive any other medications within two weeks of the COVD-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 09Mar2021 at 13:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Mar2021, Tuesday, at 22:00, the patient experienced pain in his arm. On 31Mar2021, Wednesday ,the patient experienced feeling weak, which got worse as the day progressed. The patient developed headache. The patient felt weak and had headache all day, and started feeling better at night. The patient felt a bit weak the next day but everything else seemed to be fine. Therapeutic measures for headache included treatment with Tylenol which was ineffective. The clinical outcome of the events pain in arm, feeling weak and headache was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
43 2021-07-20 pain in extremity Headache; Sore arm; Body aches; Chills; Low grade fever; Rash/hives on one finger of left hand; Rash... Read more
Headache; Sore arm; Body aches; Chills; Low grade fever; Rash/hives on one finger of left hand; Rash/hives on one finger of left hand; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old non-pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in left arm on 26Mar2021 at 10:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient had been diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26Mar2021 at 12:15, the patient experienced headache, sore arm, body aches, chills, low grade fever, rash and hives on one finger of left hand. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse events. The clinical outcome of the events headache, pain in arm, general body pain, chills, low grade fever, rash and hives was recovered. No follow-up attempts are needed. No further information is expected.
43 2021-07-20 pain in extremity headache; chills; sore muscles all over; sore throat with redness; sore throat with redness; sore ar... Read more
headache; chills; sore muscles all over; sore throat with redness; sore throat with redness; sore arm; metallic taste still present; sore; fatigue; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6204) via an unspecified route of administration, administered in right arm on 16Mar2021 at 12:00 (at 43 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There was no relevant medical history. The patient had no known allergies. Concomitant medications included meloxicam, triamterene, omeprazole, estradiol, and zolpidem; all from unspecified date for unspecified indication. The patient did not have COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination. The patient experienced sore and fatigue, both on 16Mar2021 at 12:00. The patient had metallic taste still present on 25Mar2021. The patient also had headache, chills, sore muscles all over, sore throat with redness, sore throat with redness, and sore arm; all on 26Mar2021. The events resulted in physician office and emergency room visit. The events were considered medically significant. The course of event was reported as follows: The patient reported that day after the first shot, she was sore and fatigued. Then 9 days after started with a metallic taste. On Day 10, severe headache, chills, fatigue, sore arm, sore muscles all over, sore throat with redness. All lasted for 48 hours. At the time of report, metallic taste still present and the patient was still recovering from the side effects. In 10 days after getting shot, 3 doctor visits, 2 rapid test (both were negative), negative flu test, negative strep test, intravenous (IV) with 2 bags of fluids meds, a third covid shot and blood work. The doctor sent off to have checked and awaiting on those results to come back at the time of report. The patient also added "I was told 16 strands that the test were testing for and it's believed I have one of those strands. With a negative result I've missed so much already what is my employer doesn't pay me?" (as reported). Three nasal swabs (rapid) on unspecified dates were negative. On 23Mar2021, blood test (regular test) was performed (pending results). On 26May2021, nasal swab (rapid) was negative. On 27Mar2021, blood test (rapid) was negative. Treatment received included IV with 2 bags with ibuprofen and nausea medications. Outcome of the events was recovering.
43 2021-07-21 migraine Migraine for 4 weeks after; shocking feeling in body from legs to arms; stiff neck; dose 1 on 22May2... Read more
Migraine for 4 weeks after; shocking feeling in body from legs to arms; stiff neck; dose 1 on 22May2021 10:30/ dose 2 on 22May2021; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 22May2021 10:30 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm on 22May2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included High blood pressure, and type 2 diabetes and both were controlled well, and allergies: Penicillin. Patient is not pregnant at time of vaccination. Patient did receive other medications within 2 weeks of vaccination. Migraine for 4 weeks after, shocking feeling in body from legs to arms, stiff neck and was caused emergency room/department or urgent care and hospitalized and seeing neurology doctor as symptoms are still here on 13Jun2021 07:00. The patient was hospitalized for 2 days. The treatment CT scan, MRI and visual watch were received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event Inappropriate schedule of vaccine administered was unknown while other events were recovering. Information regarding the lot/batch number has been requested.
43 2021-07-21 pain in extremity Slight sore arm; This is a spontaneous report from a contactable consumer, the patient. A 43-year-ol... Read more
Slight sore arm; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 at 11:15 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included dietary supplements (MANUFATURER UNKNOWN) from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 the patient experienced slight sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the event. The clinical outcome of the pain in arm was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-07-22 pain in extremity Fever of 100.3; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 4... Read more
Fever of 100.3; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in the right arm on 03Apr2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent lab test and procedure which included nasal swab and tested negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 12:00, the patient experienced fever of 100.3 and arm pain. On 04Apr2021, the body temperature was reported as 100.3 (unit unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fever and arm pain was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
43 2021-07-23 flushing Several minutes after vaccination, patient starting to feel light headed, and flushed. Patient drank... Read more
Several minutes after vaccination, patient starting to feel light headed, and flushed. Patient drank some water and used an ice pack on forehead, hands to cool down. After 10 minutes, she felt better and was able to walk out of pharmacy on her own.
43 2021-07-23 pain in extremity significant arm swelling and pain in arm/arm pit
43 2021-07-25 tingling Client received first dose of Pfizer Covid 19 Vaccine in left deltoid. At the end of the 15 minute w... Read more
Client received first dose of Pfizer Covid 19 Vaccine in left deltoid. At the end of the 15 minute waiting period after the vaccine, the client complained of tingling in left arm. Client verbally referred to follow up with primary care provider.
43 2021-07-25 seizure Witnessed seizure at 7:30 pm EDT on May 2, 2021. No prior medical problems. Serum sodium dropped t... Read more
Witnessed seizure at 7:30 pm EDT on May 2, 2021. No prior medical problems. Serum sodium dropped to 117. Potassium on arrival 3.3. Continued seizure activity (second seizure after arriving in ER.) Acute respiratory failure after aspirating in ER, placed on ventilator for 5 days. Acute hyponatremia; likely SIADH component related to seizure as causative factor. Prior history of low sodium November 2018. New onset hyponatremia versus any other causes. CT head with negative findings. Hypokalemia. Diarrhea reported by nursing staff. Developed pneumonia. My mother was hospitalized with low sodium 2 weeks after receiving the second dose of the Pfizer vaccine due to low sodium of 125. My seizure took place 12 days after the second dose of the Pfizer vaccine.
43 2021-07-25 sensory loss Started with itching all over, as the day progressed shoulder and arm swelled, lost feeling in hand,... Read more
Started with itching all over, as the day progressed shoulder and arm swelled, lost feeling in hand, shot area grew much larger, turned red, hot and very itchy. Extreme head aches, body aches, joint pain, nausea, light sensitivity.
43 2021-07-26 numbness, tingling About an hour after I was given the shot the right side of my face swelled and went numb and tingly.... Read more
About an hour after I was given the shot the right side of my face swelled and went numb and tingly. My right arm became numb and tingly too. it lasted for about 4 hours. it subsided around 7pm that evening. The next day I had the same occurrence as the previous day but it lasted for about 6 hours, from around 11 am till 5pm or so.
43 2021-07-26 tingling, facial paralysis Headache Neck Pain Subtle tingling in hands and feet Muscle weakness Facial Droop
43 2021-07-27 pain in extremity Back pain; Headache; Arm pain; This is a spontaneous report from a contactable consumer, the patient... Read more
Back pain; Headache; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 13:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to avocado. Concomitant medication include apixaban (ELIQUIS). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, same day after vaccination, the patient experienced arm pain for two days. On 02Apr2021, days 3 and 4 after the shot, the patient experienced headache. On 04Apr2021, day 5 and 6 after the shot, the patient experienced back pain. The events arm pain, headache and back pain resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event arm pain was resolved on 01Apr2021 while the events headache and back pain were not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-07-27 pain in extremity Arm soreness at the site of the reaction that peaked approximately 12 hours after injection; This is... Read more
Arm soreness at the site of the reaction that peaked approximately 12 hours after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP 6955) via an unspecified route of administration in the right arm on 01Apr2021 at 09:15 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and sulfonamides allergy. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA), mineral nos, vitamin nos (CENTRUM ADULT) and lactobacillus nos (CULTURELLE), all from unknown dates and for unknown indications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL 3247) via an unspecified route of administration in the left arm on 11Mar2021 at 09:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021, the patient experienced arm soreness at the site of the reaction that peaked approximately 12 hours after injection. The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event arm soreness at the site of the reaction was recovered on an unknown date in Apr2021. No follow-up attempts are possible. No further information is expected.
43 2021-07-27 pain in extremity My right arm was sore; Rubbery legs; Sinus drainage; Sore ears; Stuffy nose; Slight stomach ache; Ch... Read more
My right arm was sore; Rubbery legs; Sinus drainage; Sore ears; Stuffy nose; Slight stomach ache; Chills; Tiredness / I was tired for about a week afterwards; Sweats; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration on 24Jun2021 08:15 (age at vaccination was 43 years) as DOSE 2, SINGLE for COVID-19 immunization at Doctor's office/urgent care. The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included levocetirizine dihydrochloride (XYZAL), nicotine taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 24Jun2021, by early afternoon patient's right arm was sore. At 5:00PM (by evening) the patient experienced rubbery legs, sinus drainage, sore ears, stuffy nose, slight stomachache, chills, tiredness, and sweats. Patient was tired for about a week afterwards. The events were reported as non-serious and patient was not hospitalized. The outcome of the events was recovered on an unspecified date in 2021.
43 2021-07-27 unresponsive to stimuli hospitalized for 1 week and had to be intubated due to aspiration; unresponsive. I did come and go s... Read more
hospitalized for 1 week and had to be intubated due to aspiration; unresponsive. I did come and go speaking but made very little sense; inflammation of my heart; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnancy patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Left upper arm on 28Apr2021 14:00 (Batch/Lot number was not reported, at age of 43 years old) as single dose for COVID-19 immunisation. Medical history included peripheral nueropathy and bipolar 2 and connective tissue disorder. The patient previously took amoxicillin and experienced drug allergies. Concomitant medications included unspecified medication received in two weeks. The patient was hospitalized for 1 week and had to be intubated due to aspiration. The patient's husband found her 4 days after her 2nd shot unresponsive. The patient did come and go speaking but made very little sense. Many tests were run with nothing found to explain and she also had an echo that confirmed inflammation of her heart. Event onset date reported as 02May2021 08:00 AM. Events resulted in Hospitalization, Life threatening illness (immediate risk of death from the event), hospitalisation 7 days. The patient received treatment as Intibated, echo, O2, heart medication. The outcome of events was recovered with lasting effects. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
43 2021-07-28 flushing, feeling hot Patient is a 43 year old female who has completed a 45-minute observation period with the following ... Read more
Patient is a 43 year old female who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: other - Chest tightness and skin redness. Per patient, she had a "bad" reaction to flu vaccine and had to be sent to ED. Patient c/o feeling warm, appears flushed. Given cold pack. Lung sounds, clear. No audible wheezing. No visible rash or hives noted. Denies SOB, No tongue or lip swelling noted, no difficulty swallowing. Patient speaks in full sentences. Allergies Allergen Reactions ? Erythromycin Base Skin Rash and/or Hives and Asthma and/or Shortness of Breath ? Pcn Class [Penicillins Class] Skin Rash and/or Hives and Asthma and/or Shortness of Breath Anaphylaxis ? Trazodone And Phenylpiperazines Palpitations with 50 mg at bedtime Pfizer-BioNTech COVID-19 vaccine # 1 in series administered. o Action(s) taken: Another drug administered - benadryl 25mg PO and Recommended transfer to higher level of care, risk and benefits explained to patient, patient declined o Allergy to COVID-19 vaccine documented in Allergies activity: No, will discuss with clinician o Patient advised to discuss second dose considerations with a clinician o sent home stable. Refused to go to ED or urgent care Vitals: 07/28/21 1642 07/28/21 1700 07/28/21 1715 BP: (!) 164/80 (!) 148/68 134/76 Pulse: 80 78 72 Resp: 18 18 18 SpO2: 100% 100% 100%
43 2021-07-28 migraine The date after my second dose of Pfizer, I developed a migraine that lasted for 6 days. I've never h... Read more
The date after my second dose of Pfizer, I developed a migraine that lasted for 6 days. I've never had a migraine like this before--it didn't respond to any meds. After the migraine subsided, I was left with a dull background headache that never goes away and from time to time blooms into a migraine. On day 4 after the vaccine shot, I also developed neuropathy in the lesser occipital nerve and on top/left side of my head. These also are still present. It's been debilitating. I am being treated at the with propranolol, gabapentin, and nerve injections, but the condition persists.
43 2021-07-29 feeling hot An allergic reaction in the left arm.; Golf ball size knot; Warm to the touch; Itchy; This is a spon... Read more
An allergic reaction in the left arm.; Golf ball size knot; Warm to the touch; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Ew0217), via an unspecified route of administration, administered in Arm Left on 17Jun2021 at 16:30 (at the age of 43-years-old) as DOSE 1, SINGLE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history was not reported. Concomitant medications included oxcarbazepine (Trileptal) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall): both for an unspecified indication, start and stop dates were not reported. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. The patient stated she developed an allergic reaction in the left arm. Golf ball size knot, warm to the touch, read at times itchy on 19Jun2021. 5 days later still there. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered at the time of this report. Information on batch/lot numbers are available. Further information has been requested.
43 2021-07-29 pain in extremity, difficulty speaking First dose: Started losing voice; First dose: The next day felt like had the flu; First dose: Arm st... Read more
First dose: Started losing voice; First dose: The next day felt like had the flu; First dose: Arm started hurting; It is a hoarse voice; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EW0176), via an unspecified route of administration, administered in Right upper arm on 28Apr2021 (appointment at 12:20) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient never had allergies. Patient received first dose Pfizer Covid Vaccine earlier this month. On 28Apr2021, patient's arm was sore for a few days which she had noticed on the second day after receiving the first dose Pfizer Covid Vaccine. The next day on 29Apr2021, the patient felt like flu (not stomach flu) which didn't last long, just like a day or two. More like an achy and pain and kind of headache. Patient was losing voice on 30Apr2021. Patient had contributed this to being lethargic from receiving the Pfizer Covid Vaccine, thought it was par for the course. It was a hoarse voice, but the patient had to work to get it out. Patient got her lungs listened by a nurse a couple days ago, and lungs seemed to sound good. Outcome of the events "first dose: the next day felt like had the flu, it is a hoarse voice and first dose: arm started hurting" was unknown, while for event "first dose: started losing voice" was not recovered.
43 2021-07-29 pain in extremity a sore arm after getting the first dose.; red circle around initial injection site; warm to touch; i... Read more
a sore arm after getting the first dose.; red circle around initial injection site; warm to touch; initial injection site and was warm to touch and sore again.; and still looks swollen; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in left arm on 26Mar2021 at 14:00 (at the age of 43 years) as single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 04Apr2021 at 09:00, patient experienced sore arm, red circle around initial injection site, warm to touch, vaccination site pain and injection site swelling. The patient reported that she had nothing but a sore arm after getting the first dose. 8 days after shot (4/4) her arm had a quarter size red circle around initial injection site and was warm to touch and sore again. It continued to grow and was then a 3"x3" area and still looked swollen and red. The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm, red circle around initial injection site, warm to touch, vaccination site pain and injection site swelling were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
44 2020-12-31 hot flush itching & rash (both arms & chest) started 10 minutes after injection; treated by paramedics on si... Read more
itching & rash (both arms & chest) started 10 minutes after injection; treated by paramedics on site with benadryl 25 mg po; VS monitored for approx 15 minutes- remained normal, slightly elevated temp, lungs sounds clear, hot flashes throughout afternoon. About 45 minutes after injection took 1000 mg tylenol and 800 mg ibuprofen. additional 50 mg benadryl and 800 ibuprofen at bedtime for continued rash & itching. Next day symptoms still present, but minor. injection site became red, warm, tender to touch with small knot, 8-00mg ibuprofen taken in the morning and then 50 mg benadryl & 800 mg ibuprofen taken at bedtime. Day 3, slight itching, faint rash remains, injection site remains red, warm, tender to touch with small knot,
44 2020-12-31 pain in extremity, numbness After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt ... Read more
After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt numb after standing for a little time. The feeling of heaviness continued, but I was able to walk and completed my daily activities. My right arm felt painful similar to receiving a tetanus shot, I took some Tylenol and drank some coffee and felt better. However, the feeling of heaviness in my legs continued. On Sunday, my left leg continued to swell and I noticed that the area under my knee cap and above the upper part of the rim of my socks was visible swollen, red, and painful. I took some Motrin and the swelling improved. Later, I noticed I am having musculoskeletal pain and general body aches that improve with Mortin but returns. I am able to continue with my ADLs
44 2021-01-01 discomfort Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection ly... Read more
Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection lymph nodes very sore and swollen in armpit (pain with applying deodorant) Four days after injection bruising with about 3x3 cm area of redness/swelling present at injection site Daily headaches managed with ibuprofen Not anything too concerning but not comfortable. I have never reacted to a vaccine prior
44 2021-01-02 feeling jittery Diaphoretic palms, palpitations, jitteriness.
44 2021-01-02 flushing, numbness numb pockets on face, a little swelling of tongue and a little tired/flushed
44 2021-01-03 feeling hot, tingling felt hot, prickly, right arm red. Later felt chest tightness
44 2021-01-03 flushing, pain in extremity first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong ... Read more
first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong headache, sore throat, very tired, coughing with pain, flushed, feel as if my eyes are on fire.
44 2021-01-03 numbness Left cheek/ jaw numbness starting 10 min after injection
44 2021-01-03 migraine INJECTION SITE TENDERNESS PIXELATED VISION MIGRAINE
44 2021-01-03 night sweats 12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cou... Read more
12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cough, night sweat. 12/31 additional symptom of hypertension . As of today experiencing body aches, headache, cough, and hypertension. Medical Treatment 12/27/20 Urgent Care - 01/04/21 (virtual visit on 12/20)
44 2021-01-03 night sweats 12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the a... Read more
12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the above 12/31 - add hypertension 1/04 - still have body aches, headache, cough, fever, hypertension
44 2021-01-04 burning sensation, tingling Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she... Read more
Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she felt as if she had a "lump in her throat". Denied any type of SOB or breathing issues. @ 1650, Ee stated she felt an itching, burning, and tingling to her lips and chin. Ee also had mild edema noted to her lips. Also stated that she had onset nasal congestion. Benadryl 25mg given @ 1652. Ee remains @ observation @ present time, 1706. @ 1715 Ee stated that she had mild itching to entire body. Around 1720, stated that the symptoms were easing up. @ 1725, Ee stated that the symptoms were better, but slight itching still remained. Insisted on leaving observation, stated she was okay. Ee left observation @ 1726.
44 2021-01-04 flushing pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; te... Read more
pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; teeth hurting; cheeks were flushed and the neck; chin being red/redness on the chin; itching on the face; This is a spontaneous report from a contactable Other HCP (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in left arm on 18Dec2020 at single dose for covid-19 immunisation. Medical history included lymphoma, hodgkin's disease, inflammation. Concomitant medication included prednisone. She had to finished 2 weeks worth of prednisone, it was for inflammation in her abdomen, she had finished the prednisone either on the 18Dec2020 the following day. The patient got her first dose of the covid vaccine on 18Dec2020. She was schedule for her 2nd dose of the covid vaccine on 08Jan2021. On 18Dec2020 after receiving the vaccine her cheeks were flushed and the neck, it first started with the chin being red, an hour later her cheeks and neck were flushed, but she felt this symptom was normal. She also added that on the day of the vaccine she had itching on the face, and redness on the chin, this was on 18Dec2020 about an hour after receiving the vaccine. The enlarged lymph nodes on her neck were noticed on 23Dec2020, as well as the severe sore throat, earache, and teeth hurting. Her pain with the turning of the head was more so noticed on 24Dec2020. It's painful to turn her head back and forth but she thought this was because of lymph nodes. She stated that she had a history of lymphoma and so swollen lymph nodes did worry her. The doctor gave her an antibiotic for it, and she was actually on a second round because she was not any better. The antibiotic was prescribed on 24Dec2020, and the second round started today 29Dec2020. The first antibiotic she was prescribed was Azithromycin also known as a Z-pak. The second antibiotic she was prescribed was amoxicillin clavulanate (AUGMENTIN). Her lymph nodes were getting better starting today 29Dec2020, today was the first date that she was feeling better overall. The patient underwent lab tests and procedures which included rapid covid test negative on 24Dec2020, strep throat swab negative on 24Dec2020. She has had no positive test for Covid prior the vaccine. She had been tested like 5 times now, all negative. She had no Covid antibody test prior to vaccine. She had no issues with vaccines in the past. The outcome of event cheeks were flushed and the neck was unknown. The outcome of events enlarged lymph nodes on her neck, severe sore throat, earache, teeth hurting was recovering. The outcome of events chin being red/redness on the chin, itching on the face was recovered on 18Dec2020. The outcome of event pain with the turning of the head was recovered on 28Dec2020.
44 2021-01-04 numbness, burning sensation, flushing, tingling Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin... Read more
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
44 2021-01-04 night sweats Initially I was fine, but after 2 hours I started feeling joint pain. The next day the pain got wors... Read more
Initially I was fine, but after 2 hours I started feeling joint pain. The next day the pain got worse and caused me to limp at work. I started feeling down. That night, I went home and had chills and fever. I was sweating in my sleep. I was fine on Christmas and now I have bronchitis like symptoms. I've seen 3 different providers at urgent care and was told that they don't know much about the vaccine. They told me to use Albuterol and go to the hospital if I get worse. I was told that I still have the antibodies from already having COVID twice and it may be causing me to have problems now. The first time was really bad and I developed pneumonia, but didn't go to the hospital due to all of the deaths occurring in city.
44 2021-01-04 throat numbness lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips... Read more
lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; developed a cough once the numbness and tingling reached my throat; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 15:30 at a single dose for COVID-19 immunization. Medical history included thyroidectomy for thyroid cancer, anaphylaxis to mangoes and allergic to multiple medications. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine and liothyronine. The patient received the vaccine at 3:30pm, ten minutes later her lips, tongue and throat became numb and tingly. She developed a cough once the numbness and tingling reached my throat. She was given Benadryl at the time, 15 minutes after injection. She was still having numbness and tingling to the back of her tongue currently (8 days after injection). The patient was not hospitalized for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel.
44 2021-01-05 feeling hot, pain in extremity Hot; heaviness in right arm / sore; feeling flushed; feeling hot in legs. Monitored for total of 40... Read more
Hot; heaviness in right arm / sore; feeling flushed; feeling hot in legs. Monitored for total of 40 minutes. Laid on a stretcher and systems resolved. Released to home.
44 2021-01-05 feeling jittery Headache; Low grade fever - 99.3; Shaky and jittery feeling that kept me from sleeping soundly; Shak... Read more
Headache; Low grade fever - 99.3; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; This is a spontaneous report from a contactable Healthcare Professional reporting for a patient. A 44-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730), intramuscular in the left arm on 30Dec2020 at 09:00 as a single dose, for COVID-19 immunisation. The patient had no known medical history or allergies. Concomitant medication included rosuvastatin calcium (CRESTOR). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Dec2020 at 2300, the patient experienced Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly. No treatment was given for the events. The clinical outcome of Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly was recovering.
44 2021-01-05 migraine Persistent migrane pain with nausea
44 2021-01-05 pain in extremity, feeling hot, hot flush 15 minutes after the injection, I got some itching on my right shoulder near the injection site. I w... Read more
15 minutes after the injection, I got some itching on my right shoulder near the injection site. I waited around a bit longer and the itching and heat started to grow down my arm and across my chest and back. I was asked to go to the ER as it was not resolving. At about one hour, I started to get some mild chest pain, My BP was 173/101 and around 100+ for heart rate. O2 was 100% . ER staff did an EKG. The ER DR gave me Pepcid, Benadryl and Prednisone and 1 liter of normal saline. I was observed for about 3 hours. I went home and was feeling much better. The next 3 days I had a moderate headache and sore arm. I took Tylenol. I had some hot flushes and mild spikes of temperatures 100-101F, through the next couple of days.
44 2021-01-05 pain in extremity arm pain/arm is sore where she got the shot; shivering; body aches; headache; This is a spontaneous ... Read more
arm pain/arm is sore where she got the shot; shivering; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the arm on 29Dec2020 at 15:20 at single dose for COVID-19 immunization. Medical history included thyroid issue, low blood pressure from an unknown date and unknown if ongoing, surgery for an ovarian cyst in 1999 (She had surgery for an ovarian cyst 21 years ago), cyst on her tailbone removed in 2016 (had cyst on her tailbone removed 5 times. The first removal was in 2016. It was removed twice in 2017 and then twice in 2018). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid issue. The patient got the vaccine on Monday (29Dec2020) and waited the 15 minutes then felt okay. Then on Tuesday (30Dec2020) she developed/woke up with arm pain and shivering, body aches and mild headache. She woke up with arm pain, shivering, body aches, and headache. The patient states it is very mild. She is sitting there shivering and has body aches. No joint pain. Her arm is sore where she got the shot. When you feel pain, you automatically have a headache. Side effects started this morning around 9:30AM or 9:45AM. She felt nothing when she was in the bed. When she went into living room for breakfast she felt shivering. She called her friend that got the injection yesterday too and her friend feels ok and gave her the number to call. Therapeutic measures were taken as a result of the events which included treatment with Tylenol. The patient was recovering from the events. Information about lot/batch number has been requested.
44 2021-01-05 pain in extremity immediate nausea, headache, dizziness (feeling of motion sickness) and arm pain, tiredness. ongoing ... Read more
immediate nausea, headache, dizziness (feeling of motion sickness) and arm pain, tiredness. ongoing headaches, fatigue, dizziness and nausea on and off every day
44 2021-01-05 tingling, numbness I got the vaccine and three hours later I had both legs below the knee go numb and start tingling .... Read more
I got the vaccine and three hours later I had both legs below the knee go numb and start tingling . They are still tingling today but the numbness went away the day after I had the vaccine.
44 2021-01-05 tingling, migraine with aura Had tingling in feet shortly after vaccine. Waited 15 minutes, was cleared to go home, on walk to ca... Read more
Had tingling in feet shortly after vaccine. Waited 15 minutes, was cleared to go home, on walk to car, migraine aura started. I rarely get migraines. Got worse and worse as I drove home, could barely see. Severe headache followed.
44 2021-01-05 tremor, feeling of body temperature change, tingling Symptoms - ? EE reports she waited for 30-minute observation period with no adverse reaction. EE le... Read more
Symptoms - ? EE reports she waited for 30-minute observation period with no adverse reaction. EE left work to drive home after vaccine and reports approximately 45 minutes later felt ?hot and cold? all over her body and felt ?panicky.? EE reports she pulled over and called her husband. At time of call (approx. 13:33), EE reports still feeling a little ?tingly? on her entire body and ?odd.? EE reports mild shaking to bilateral hands. EE reports last time she ate was at approximately 06:45 this am. Home remedies? - EE was in Starbucks parking lot at time of call and was going to be getting lunch after call. Recommendation? EE educated to eat and drink something, EE verbalized back understanding. EE educated to call vaccine support line for worsening symptoms, EE verbalized back understanding and denied further questions at this time.
44 2021-01-06 weakness, pain in extremity Generalized Weakness, arm sore, sore throat, runny nose
44 2021-01-06 burning sensation, nerve pain, tingling Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hur... Read more
Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hurt swollen lymph nodes tingling on the left side of her face
44 2021-01-06 discomfort, tingling tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BIL... Read more
tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BILATERALLY - felt like she was going to pass out and have diarrhea and vomit at same time - these symptoms awakened her from sleep at 11:45pm; sxs lasted about 15 minutes and then abated; tingling in 4th/5th fingers BILATERALLY persists today- though much less intense - reports at level of 1/10; never did vomiting and never had diarrhea; never passed out; feeling well today - able to run 4 miles and teach yoga and work at a physical therapist
44 2021-01-06 hot flush Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and F... Read more
Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and Famotadine 40 mg prior to going to F13 clinic for her covid vaccination. Patient stayed an hour after vaccine administration to be monitored. She came to ER for further monitoring and allergic reaction concerns and received 2 doses of 25 mg diphenhydramine. She was reporting itching of her trunk and arms, itchy throat, and hot flashes. She was monitored in ER, she maintained airway and stayed on RA the entire visit.
44 2021-01-06 numbness Facial numbness bilaterally with headache 3 hours post injection. 15 hrs post injection: 101 tempera... Read more
Facial numbness bilaterally with headache 3 hours post injection. 15 hrs post injection: 101 temperature, severe chills and joint pain (making it difficult to walk), body aches and extreme fatigue. Headache continued but facial numbness subsided. Symptoms less severe at 48hrs, low grade temp and body aches persisted, joint pain resolved. All symptoms resolved at 72 hrs.
44 2021-01-06 migraine Severe joint pain, migraine headache
44 2021-01-06 tremor Approximately 10 minutes after vaccination developed increased heart rate, dizziness, and shakiness.
44 2021-01-06 trigeminal neuralgia 5d after vaccine I developed a R sided trigeminal neuralgia of branches 1 & 2. By d10 I developed t... Read more
5d after vaccine I developed a R sided trigeminal neuralgia of branches 1 & 2. By d10 I developed the rash consistent with herpes zoster, including ophthalmic involvement of the R eye. I have not previously had shingles, but did have varicella as a child. I went to the ER as it was the middle of the night on the weekend and as a physician I realized the eye involvement required immediate treatment. I have since had to see the ophthalmologist x2. The shingles itself is improving, and the eye has healed with steroids and valtrex. I did still receive my 2nd booster shot on 1/5/21 and thus far have not had any additional effects.
44 2021-01-07 weakness moderate myalgias, fatigue, back pain, extremity pain and weakness
44 2021-01-07 hot flush FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, L... Read more
FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, LOSS OF APPETITE , PAIN AT VACCINATION SITE, LEFT AXILLARY PAIN ON ABDUCTION. UNABLE TO GO TO WORK DUE TO SYMPTOMS
44 2021-01-07 numbness, discomfort Myalgia bottom lip feels heavy, jaw feels heavy, bottom lip and jaw numbness Narrative:
44 2021-01-07 numbness Swollen area under the skin on left hand that is causing numbness in the palm, thumb and first fing... Read more
Swollen area under the skin on left hand that is causing numbness in the palm, thumb and first finger. Some swelling to the hand as well
44 2021-01-07 numbness facial numbeness x 1h; bilateral Narrative: self limited bilateral facial numbness
44 2021-01-07 migraine, migraine with aura Migraine with auras (no previous hx of auras), currently for 2 days and ongoing. OTC meds and rizatr... Read more
Migraine with auras (no previous hx of auras), currently for 2 days and ongoing. OTC meds and rizatriptan having no effect
44 2021-01-07 pain in extremity Sore arm, Joint pain, Fever, Fatigue, Back pain(muscles in back), Headache x 2 days so far
44 2021-01-07 pain in extremity I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning... Read more
I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning it was pounding, spread to the right half of my head, nausea, photo sensitivity, vertigo. It took 36 to 48 hours before I could function. 48 to 72 hours later I had another headache with vertigo. I had complete vision loss in my left eye.
44 2021-01-07 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at inject... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at injection site and has not gone away, gets worse with some motions, has not been red or swollen Makes dressing, reaching, dishes, laundry, putting on a backpack, working with patients all painful (I am a physical therapist in the hospital) I have an old injury to the long head tendon of my biceps in the L arm and originally thought it just flared that up for some reason, but the pain is also more lateral by the injection site I have been resting it, trying not to aggravate it, using some tylenol as needed for sleeping as positioning is hard lately, and it's been hurting more towards the end of the day It is not getting better, and I feel like may be getting a little worse. I am going to start icing it this weekend too. It is starting to affect how I do my daily activities and my job - I am considering going to the doctor
44 2021-01-07 pain in extremity slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positiv... Read more
slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positive for covid 19 virus; feel tired; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was Diagnosed with covid 19 virus on the 31Dec2020, she was set to have the second vaccine on the 10Jan2021. She wanted to know if she can get the second dose and if so, when. Also asked if she should get tested before taking the 2nd dose of the covid 19 vaccine. Her Adverse effects are sore arm on vaccination day (20Dec2020), and she began to feel tired on 27Dec2020 and thought that was normal. She went to a Christmas eve party 24Dec2020 and no one was masked, friend had several people from work tested positive. was tested and was positive for covid 19 virus on 31Dec2020. She also was experiencing slight cough, diarrhea (which is normal for her), shortness of breath is improving and she had no sense of smell but she was able to taste. The outcome of event shortness of breath is recovering. The outcome of other events was unknown. No follow-up attempts are possible. information about lot/batch number cannot be obtained.
44 2021-01-07 pain in extremity I had fever and arm was sore. I felt fatigue and very tired.
44 2021-01-07 tingling shoulder pain in the joint space causing paresthesia in the hand and arm with intermittent pain in t... Read more
shoulder pain in the joint space causing paresthesia in the hand and arm with intermittent pain in the forearm. loss of full range of mobility in the shoulder. this has been ongoing x 1 week.
44 2021-01-07 tremor Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; m... Read more
Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; metallic taste in the mouth; burning in the eyes; chills; shaking; This is a spontaneous report from a contactable physician, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection on 24Dec2020 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020 at 07:00, the patient experienced sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking which lead to doctor or other healthcare professional office/clinic visit. Treatment was provided for the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking with NSAIDs. The outcome of the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking was not recovered. Since the vaccination, the patient has been tested for COVID-19 on 30Dec2020 via Nasal Swab and Antigen test and both were negative.
44 2021-01-07 tremor Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became ha... Read more
Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became hard to breathe, my fingers were tingling and my mouth got very dry. I pulled over and called 911. The paramedics stated my BP was within normal limits of around 140/80. My normal is closer to 90/65. Once symptoms resolved I attempted to drive home. Once again, the same symptoms returned. I pulled over. I then made my way to a safe location and waited for family to come. Since the event I have had times of mild labored breathing while walking. While driving I become very anxious and the feelings of an anxiety attack return. I saw my nurse practitioner 2 days ago who referred to the driving anxiety as a form of PTSD and prescribed Prozac and Xanax. I have not take the Xanax, but have taken two nighttime doses of Prozac. Yesterday, I did not feel as though I had taken medication. My drive to work was uneventful. My drive home involved tightening of the chest, labored breathing and anxiety. This morning I cannot tell if I am feeling the vaccine or Prozac in my system, but I feel off. Swimmy headed, watery mouth, heaviness in my arms and shoulders. I need guidance on taking the 2nd vaccine or if I should seek further medical treatment. I have added a vit B vitamin a day to my regimen since the date of the vaccine.
44 2021-01-08 facial pain I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and di... Read more
I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and diagnosed with Shingles. I had blisters with redness scalping which fell off on 1/8.
44 2021-01-08 feeling hot Headache, Myalgia, NauseaVomiting, C/O light headness,felt hot,fatigue,chills,neck achy,injection si... Read more
Headache, Myalgia, NauseaVomiting, C/O light headness,felt hot,fatigue,chills,neck achy,injection site pain,swelling and warmth. Told to follow up with primary care doctor Narrative:
44 2021-01-08 pain in extremity Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days... Read more
Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days Severe headache x 2 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Mild headache x 1 day (OTC Ibuprofen 400mg PRN) Dizziness x 2 days (Ensured proper hydration) Body aches x 3 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Malaise x 3 days
44 2021-01-08 tremor Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medic... Read more
Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medication for it and I informed her that it would still be recommended to get the vaccine. She was visibly anxious even after vaccine. Immediately after she began crying to her friend and said she "was just SO afraid of needles". I told her to take some deep breaths and after a minute or two she went to the observation room. Approximately 15 minutes later she rushed back into the room looking like she might hyperventilate or have hypoglycemia (shaking, cold sweats). She sat down and I tried to calm her down. I asked someone to get her orange juice. During the next couple minutes she did not seem to be getting any better and started shaking. I requested someone call 911. Another staff was helping so I moved to get and administer an epi-pen injection. By this time the patient was not responsive, but was still breathing. I instructed staff to help move her to the floor for monitoring and if needed, cpr. She regain partial consciousness. Her breath and pulse were always present, so there was no need to begin cpr. After a few minutes EMT arrived and transported patient to local hospital. During all of this, other employees at the facility were attempting to contact family members, which they were eventually able to do. About 30 minutes later the staff informed me they had spoken to family members who were at the hospital and that she was improving, but they had not seen her yet.
44 2021-01-08 tremor Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three... Read more
Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three days I have started having violent shaking.
44 2021-01-09 feeling cold Pfizer-BioNTech COVID-19 Vaccine EUA Chills (low temp), fever (102), bad headache, overall body ache... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Chills (low temp), fever (102), bad headache, overall body aches, fatigue. Taking Tylenol and Aleve around the clock. Still ongoing.
44 2021-01-09 pain in extremity, tingling, numbness As soon as 3 seconds after the shot my right hand was numb and tingling. The tingling sensation is s... Read more
As soon as 3 seconds after the shot my right hand was numb and tingling. The tingling sensation is still there and I have chronic pain in my elbow running down my arm into my ring and pinkie finger.
44 2021-01-09 tremor, inability to speak I am not sure if related on not. This event was 13 days after my COVID-19 1/2 immunization. Otherwis... Read more
I am not sure if related on not. This event was 13 days after my COVID-19 1/2 immunization. Otherwise, I am a very healthy physician, normal BMI, I have also been tested 5-6 times negative for COVID. I do get exposed in my job, but wear proper PPE. Viral infection in FEB that was like COVID-19 sx, I did AB test as soon as it was available, and negative. ---The Event: Monday morning (1/4/21), after getting out of shower, I was talking to my husband (who is MD)and started having BROCA's aphasia sx (could not get words out coherently), then fell into bed and started right wrist and right foot posturing. This lasted 10 min. I have non-memory of it, but my MD husband witnessed it. After 10 minutes, I was back to normal, except shaky and some word finding difficulties. After 30 min, totally back to normal.
44 2021-01-10 night sweats, pain in extremity, feeling hot Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on r... Read more
Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on right side of neck, close to collar bone. Very sore. As of today, Monday, 1/11, it is more swollen and hurts. And I'm still having night sweats plus am extremely hot but not having a fever.
44 2021-01-10 pain in extremity Achy, chills, arm pain
44 2021-01-10 tingling Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tin... Read more
Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tingling on her face and then after 5 more minutes she said she felt her throat tingling. Our safety officer who is a DR was called ans ordered a dose of epinephrine 0.5 ml to be given and then call the EMS.
44 2021-01-10 tingling Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain fr... Read more
Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain from shoulder to forearm, pain got better with regular daily movement. Enlargement of the injection site welt, increase firmness, redness and diameter, deep centrally located bruise. Shoulder begins to ache consistently worsening with movement or pressure to area. Mon. Jan 11, 2021 More noticeable swelling to left axilla and swelling appears to left upper outer pectoral area and below clavicle. Arm feels heavy and like fluid is traveling down arm and into hands/fingers. Fingers, wrist and forearm have brief periods tingling and pain. Swelling feeling in left extremity feels better when hand is held up over head.
44 2021-01-10 tenderness 1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore ar... Read more
1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore arm at injection site, left axilla pain and swollen left axillary lymph nodes 1/9 to- present: swollen axillary lymph nodes and tenderness left axilla
44 2021-01-10 tremor chills, shakes, nausea, vomiting, lightheaded
44 2021-01-11 weakness, pain in extremity 1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a... Read more
1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a couple hours. Took ibuprofen which helped. Low grade fever 99.8, EXTREME weakness and fatigue, body aches devloped evening with profuse watery diarrhea 1/7-1/10, poor appetite (NO nausea, NO vomiting) also had mild symptoms of intermittent runny nose, itchy eyes, mild cough. Symptoms improved 1/11/21 with decr freq diarrhea, improvement energy level. I pushed fluids in home and ate soup. Visit to urgent care 1/11/21 for IV hydration after receiving covid testing req for job d/t symptoms. 1/12/21 feeling improvement in symptoms but not fully recovered at this time-monitoring symptoms in home
44 2021-01-11 weakness Body aches, temperature 99.5, weak, dizzy, chills, fatigue, upper chest congestion, nausea, upset st... Read more
Body aches, temperature 99.5, weak, dizzy, chills, fatigue, upper chest congestion, nausea, upset stomach
44 2021-01-11 involuntary muscle movements received COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had atonic rea... Read more
received COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had atonic reaction: involuntary muscle movements and lasted for 3 days,
44 2021-01-11 involuntary muscle movements Received the COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had involu... Read more
Received the COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had involuntary muscle movements and lasted for 3 days
44 2021-01-11 feeling hot About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rat... Read more
About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rate went to 140bpm. I alerted RN, gave me water, juice took about 20 minutes for HR to fo down to around 100. Did not go to ER. Went home, rested. HR returned to 80bpm around 3pm. Metoprolol taken two hours prior vaccine.
44 2021-01-11 feeling hot pt felt heart racing, warm ears and face. Pt monitored and given water. Symptoms resolved at 1721.
44 2021-01-11 feeling hot On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this ... Read more
On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this for at least 16 hours (very uncomfortable). Also, on January 6, 2021 at 1130pm I had horrible stomach pains, then started vomiting, after I was done vomiting I felt better. I did take 2 Benadryl and aleve to help When I got back injections and had surgeries I had the same reactions happen to me usually after 8-10 hours after I was out of surgery. I was given medicine to help with the discomfort either through IV or Benadryl.
44 2021-01-11 feeling hot 24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and... Read more
24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and cheeks where I had dermal filler injections in March 2020. This did not resolve with Benadryl 50mg. On 1/10/21 I was given a Rx for prednisone and the tenderness and swelling resolved with 40 mg of Prednisone.
44 2021-01-11 flushing Immediately following shot developed facial flushing,nausea,dizzy. Transoported to AFM for assessmen... Read more
Immediately following shot developed facial flushing,nausea,dizzy. Transoported to AFM for assessment
44 2021-01-11 flushing Flushing, irregular heart beat, redness on chest
44 2021-01-11 numbness, tingling I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was i... Read more
I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was in my arm and up into my chest and back. I felt like I was going to pass out. The numbness and tingling still hasn't gone away and my heart still races.
44 2021-01-11 migraine I received the vaccine in the morning on 12/31/2020 and woke up on 01/01/2021 with a migraine, much ... Read more
I received the vaccine in the morning on 12/31/2020 and woke up on 01/01/2021 with a migraine, much worse than my usual migraines. It was gone by the morning of 1/2/21. I was advised to report this.
44 2021-01-11 pain in extremity, weakness Pfizer-BioNTech COVID-19 Vaccine EUA Five minutes after I received the vaccine, my arm was sore and ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Five minutes after I received the vaccine, my arm was sore and my throat felt a little tight. Then, I started to feel kind of lightheaded and my legs were weak. I let the staff know and they offered me benadryl but I declined. I waited about 35 minutes then I went home. I continued to feel lightheaded and weak for about 4 hours and I also began to fill nauseous. My arm continued to be sore for a few days and I ran a fever of around 100 from the following day 1/9 and I am still running a fever now on 1/12.
44 2021-01-11 pain in extremity, weakness Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild f... Read more
Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild fever 99.8. EXTREME weakness and fatigue, profuse diarrhea, poor appetite, feeling morose, intermittent runny nose, itchy eyes, mild congestion and mild rare coughing spells. Please note- shot in first series was not painful- couldn't even feel shot. Only symptom after shot in 1st series was mild arm pain and mild fatigue for 2 days.
44 2021-01-11 pain in extremity slight sore arm; slight chest congestion; positive COVID-19 test after first dose of vaccine; positi... Read more
slight sore arm; slight chest congestion; positive COVID-19 test after first dose of vaccine; positive COVID-19 test after first dose of vaccine; Fever; cold like symptoms; stuffy head; horrible headache; Cough; This is a spontaneous report from a contactable healthcare professional (patient) from a Pfizer-sponsored program, Pfizer First Connect. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 16Dec2020 as a single dose (reported as 0.3 mL) (at the age of 44-years-old) for COVID-19 immunization. Medical history included ongoing hypothyroidism, one thyroid gland removed due to a nodule on an unspecified date (years ago), ongoing acid reflux, ongoing hypercholesteremia, ongoing fluid retention, and ongoing history of headaches. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism and for one thyroid gland removed due to a nodule from an unspecified date and ongoing, dexlansoprazole (DEXILANT) taken for acid reflux from an unspecified date and ongoing, atorvastatin (LIPITOR) taken for hypercholesterolemia from an unspecified date to an unspecified date, and hydrochlorothiazide (MANUFACTURER UNKNOWN) taken for fluid retention from an unspecified date and ongoing. Additional concomitant medications included unspecified vitamins. The patient had a positive COVID-19 test after first dose of vaccine on 01Jan2021; cold like symptoms, stuffy head, horrible headache, cough, and fever on 31Dec2020; slight chest congestion on 02Jan2021; and slight sore arm on an unspecified date. The events, stuffy head and horrible headache, were reported as medically significant. The events, cough, fever, and slight chest congestion, were reported as non-serious. The clinical course was reported as follows: It was reported that the patient was vaccinated on 16Dec2020, became symptomatic on 31Dec2020, and tested positive for COVID-19 on 01Jan2021. The patient stated that she became symptomatic one day prior to testing positive for COVID-19, on 31Dec2020. She initially had cold-like symptoms with a stuffy head, cough and a horrible headache; the worst headache she had ever had. These symptoms occurred earlier in the day on the 31Dec2020. Then later that night about 10:00 PM, she had a fever with a body temperature of 102 degrees Fahrenheit. Her body temperature had been normal at 98 degrees all day that day until that night. She also had slight chest congestion and then was fever free for over 48 hours. The patient stated that she had a history of headaches and can tolerate a headache. The headache started 31Dec2020 and was significant. It was reported that after the vaccine, she had no other symptoms other than a slight sore arm, which lasted a day; maybe 24 hours after she received the vaccine. The patient stated that she does not think any of the other symptoms, other than the sore arm, have anything to do with the vaccine. The clinical outcome of positive COVID-19 test after first dose of vaccine and slight sore arm was unknown; cold like symptoms, horrible headache, and cough was recovering; fever was recovered on 02Jan2021; and stuffy head and slight chest congestion was not recovered. The reporter assessed the causality assessment between the events, positive COVID-19 test after first dose of vaccine, cold symptoms, stuffy head, cough, horrible headache, fever, and slight chest congestion, as unrelated. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
44 2021-01-11 pain in extremity Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm follow... Read more
Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm followed by numbness and tingling (pins and needles), a few minutes later I experienced a dull headache. The arm sensation slowly subsided by the time my fifteen minutes was up. The dull headache lasted through the night Around 9 pm, I experienced chills, that lasted for 2 days with body aches and sore right and left arm. During the night, I had a hard time sleeping experiencing nightmares. Woke up at 2 am took a walk felt a little better. Chills continued throughout the night. Friday- chills continued with body aches and a general feeling of malaise. Temp was 98.7 at highest, bp 122/79, hr 80, and blood sugar 149, I have no hx of diabetes. Saturday- "hungover feeling" - headache that came in waves with a general feeling of malaise. Sunday- Pounding headache, extreme fatigue-slept until 1500 woke up and then went back to bed, body aches-worst I have felt in years. Monday shaky feeling somewhat better still malaise. Tuesday vomited all my breakfast, feeling of phlegm or something stuck in my throat. BP 120/77 hr 64 temp 98.4. Continued body aches.
44 2021-01-11 pain in extremity body aches nausea, very sore arm 1 day after i2nd injection
44 2021-01-11 tingling Patient reported tongue swelling that lasted for 3 minutes and then finger tingling which occured fo... Read more
Patient reported tongue swelling that lasted for 3 minutes and then finger tingling which occured for 3 minutes.
44 2021-01-12 feeling hot, flushing 10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was swea... Read more
10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was sweating and short of breath. My peripheral vision was cloudy. This lasted approx ten minutes.
44 2021-01-12 numbness, inability to speak numbness to forearm then to lower leg that then took on a dermatomal pattern, brain fog w word findi... Read more
numbness to forearm then to lower leg that then took on a dermatomal pattern, brain fog w word finding issues that progressively worsened, LLE weakness. ct brain neg. MRI/MRA head and neck neg. labs neg. MRI of c spine t spine l spine s spine neg. emg and eeg neg. discharged from hospital. symptoms fluctuating. slowly improving.
44 2021-01-12 migraine About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't... Read more
About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't feel right." No SOB. C/o 7/10 migraine headache. Nausea but no vomiting. Frontal lobe pain. Dizzy. Felt like she was drunk. BP 136/29, HR 79. Became slower to respond to questions and a rapid response was called. Transported to ED for observation where patient received acetaminophen 975mg po x 1 and metoclopramide 10mg po x 1. Patient declined NS 1L bolus. Per ED note, patient presented with likely vasovagal episode after receiving COVID-19 vaccination. Patient's symptoms improved and patient was discharged home.
44 2021-01-12 pain in extremity Severe bodyaches, chills, fatigue, nausea last in two days. Used Tylenol and ibuprofen to treat symp... Read more
Severe bodyaches, chills, fatigue, nausea last in two days. Used Tylenol and ibuprofen to treat symptoms. Still have left arm soreness on day 2 after injection . Body aches are better on the day 2 but not resolved yet, so his fatigue.
44 2021-01-12 tingling, numbness The day after my vaccine(1/8/21), I noticed pins and needles/tingling sensations in my left foot and... Read more
The day after my vaccine(1/8/21), I noticed pins and needles/tingling sensations in my left foot and left hand. I have never had this happen before. IT lasted for about 15 minutes that night. The day after that(1/9/21), it happened again in the evening and lasted about 10-15 minutes. The morning after that(1/10/21), I had the pins and needles/tingling and a bit of numbness in my left hand that lasted for a few hours. That evening(1/10/21), I had the sensations again in my left hand, as well as noticing a prickling/itching sensation on both of my shoulders. That lasted for about 30 minutes. That was the last time I experienced it and have not experienced it again in the last 2 days.
44 2021-01-13 weakness THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,J... Read more
THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,SWELLING ON INJECTION SITE,NAUSEA,INFLAMATION OF NODES.
44 2021-01-13 cold sweat "my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild ... Read more
"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild soreness to back of tongue. sent for obs. took zyrtec, tylenol prior to getting vaccine. eupneic, a/ox4, skin w/d. no distress" Blood pressur 160/91
44 2021-01-13 difficulty speaking, flushing, cold sweat Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness imme... Read more
Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness immediately after getting her first dose of the Pfizer COVID-19 vaccine at 1030 this morning. 26 minutes later the symptoms are followed by cold sweats. She feels much better now, does not now, did not have shortness of breath, nausea, vomiting, wheezing, change in voice, difficulty swallowing. Patient reports the symptoms are similar to but much milder than the symptoms she gets during rituximab infusion for her myasthenia gravis. Patient notes that she took Zyrtec and acetaminophen at 9:00 as premedication. Prior to this patient had been well, no fevers, nausea, vomiting, diarrhea, chest pain, shortness of breath, cough, sore throat, urinary problems, or other problems. Patient did not receive any additional therapy in the ED. She was observed for 2 hours in the ED and was subsequently discharged home.
44 2021-01-13 flushing, weakness 12 HOURS AFTER INJECTION, SEVERE JOINT PAIN, FLUSHING, LOW GRADE FEVER AND WEAKNESS. LASTED UNTIL 24... Read more
12 HOURS AFTER INJECTION, SEVERE JOINT PAIN, FLUSHING, LOW GRADE FEVER AND WEAKNESS. LASTED UNTIL 24 HOURS AFTER THE VACCINATION AND THEN JUST TIREDNESS AND SLIGHT MYALGIAS FOR FURTHER 12 HOURS.
44 2021-01-13 flushing With second COVID vaccine, patient experienced flushing, dizziness, lightheadedness, and diaphoresis... Read more
With second COVID vaccine, patient experienced flushing, dizziness, lightheadedness, and diaphoresis. Patient was given water/juice and was discharged in stable condition home.
44 2021-01-13 night sweats Approximately 28 hours post injection I developed profuse sweating that lasted all night (approximat... Read more
Approximately 28 hours post injection I developed profuse sweating that lasted all night (approximately 8 hours). I do not normally sweat in my sleep. I did not check my temperature. I had a brief moment of chills lasting <5 minutes at 10pm. I did not feel like I was febrile. I did not take any medication for any side effects.
44 2021-01-13 pain in extremity, feeling hot 5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpita... Read more
5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpitations; drank a juice & some water 10 minutes later - sweats/chills, still dizzy, BP decreasing 135, agitated 20 minutes later - still sweating,/chills, head clearing, heart palpitations subsiding, Tired, legs/body very heavy. Dizzy when walking, told to rest longer 30 minutes - still sweating/chills, could only walk short distance with heavy legs and dizziness, told to rest longer 40 minutes - massive headache, slight dizziness, continued leg heaviness. nausea, light sensitive, very itchy arm. Did not feel better until 11:30 PM that night Woke in the morning with just a sore arm, runny nose and an over-all fatigue, a little cough
44 2021-01-13 pain in extremity Left arm soreness 24 hours post injection (minimal) that improved within 48 hours. Supraclavicular ... Read more
Left arm soreness 24 hours post injection (minimal) that improved within 48 hours. Supraclavicular lymph node (left side- mildly tender), left sided neck pain, and left forearm tenderness that began almost 72 hours post vaccine. No fever. No other symptoms
44 2021-01-14 weakness, flushing 0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives... Read more
0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives to left side of neck 1005 another 50 mg of Benadryl PO taken and Tylenol 650 mg PO for chills and headache 1200 famotidine PO taken for burning to stomach 1400 diarrhea and weakness. Hives had subsided 1800 another round of Benadryl and Tylenol and famotidine. Saturday at 0200 woke up abruptly itching all over. Took more Benadryl. Saturday all day medicated every six hours with Tylenol, Benadryl and Pepcid. Diarrhea continued with abdominal cramps. Sunday continued same treatment for same symptoms. Hydration was aggressive and added Bentyl. Monday, Tuesday and Wednesday symptoms continued except for the itchiness. Continued Tylenol. Diarrhea persists as well as body aches, weakness and headaches. Friday, it is now a week and I still have diarrhea and chills and weakness.
44 2021-01-14 facial paralysis, weakness, numbness, tingling Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the c... Read more
Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization. Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested.
44 2021-01-14 pain in extremity Right arm pain; This is a spontaneous report from a contactable physician. A 44-year-old non-pregnan... Read more
Right arm pain; This is a spontaneous report from a contactable physician. A 44-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: Eh9899), via an unspecified route of administration in the left arm on19Dec2020 10:30 at a single dose for covid-19 immunization. The patient has no relevant medical history. Patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 19 December 2020, the patient experienced right arm pain. No treatment was given for the event. The outcome of the event was recovered. The vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Information on Lot/Batch has been requested.
44 2021-01-14 pain in extremity feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm... Read more
feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed; chest pain; chest pain, going into her back, on her left side; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, NDC number: 5926710001), intramuscular on 07Jan2021 (around 10ish in the morning) at single dose at right arm for covid-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. At the beginning of the week, patient had some vertigo but when she went in for her second vaccine, the vertigo was gone already. There were no concomitant medications. There was no adverse event following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC: 59267100002 Lot: EH9899) intramuscular on 17Dec2020 at single dose at right arm for covid-19 immunization. Patient received the second dose of the vaccine in the morning, around 10 something on 07Jan2021 at the hospital she worked at. She started feeling badly around 7:00 at night 07Jan2021 with chills, 101.6 fever, terrible muscle aches, a headache. Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed. She was having chest pain, going into her back, on her left side. When probed for the outcome of these symptoms, patient stated she had a fever, but not quite as high. She had been taking paracetamol (TYLENOL) and it was not helping. Patient provided the following product information for the paracetamol she was taking: TYLENOL, 500mg NDC: 6984270778 Lot: 9MR0454 Expiry date: Oct2021. The back pain/muscle pain was still there. She had chills but not as badly. The soreness in her arm had improved. Her arm was still sore, but not like it was yesterday. Outcome of events feeling badly, headache and chest pain was unknown, outcome of events chills, fever/ 101.6 fever, arm was so sore she couldn't even move it was recovering, outcome of events back pain/muscle pain was not recovered. The report is considered as non-serious. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. History of all previous immunization with the Pfizer vaccine considered as suspect. No further information was provided or obtained.
44 2021-01-15 weakness 2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a hea... Read more
2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a headache and felt tired so took some melatonin, had a hot toddy, and went to bed early. Woke up roughly 18 hours post vaccine with back aches and lower rib pain when I took a breath. Took my temp, it was 100*. By 21 hours I had a temp of 102*. My groin, neck, and left arm pit lymph nodes were enlarged as well. After sleeping most of the day away, it felt like my fever 'broke' at 28 hours, it came down to 101*. Finally I took some Tylenol at 34 hours so I could sleep from the back pain. Woke up the next morning at 45 hours with a stiff back/neck but temp down to 99*. I also had a swollen and reddened entire deltoid where the shot had been given (painless when shot given and no blood after), almost like a cellulitis or allergic reaction. My left armpit lymph node remains enlarged but not as painful. Now almost 72 hours out, the only residual effects are a decreasing but enlarged left armpit lymph node, improving swollen/reddened deltoid, decreased appetite, and decreased energy level.
44 2021-01-15 pain in extremity Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: missed work 1/8/2021
44 2021-01-15 tingling, numbness Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe i... Read more
Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11
44 2021-01-16 pain in extremity, numbness Severe muscle aches in both legs Left arm hurt to move Numbness in left arm to fingertips and both f... Read more
Severe muscle aches in both legs Left arm hurt to move Numbness in left arm to fingertips and both feet once muscle pain went away in extremities.
44 2021-01-17 numbness, tingling My face started to go numb and feel tingly. My ears also felt plugged, as if I were changing elevat... Read more
My face started to go numb and feel tingly. My ears also felt plugged, as if I were changing elevations. The effects lasted for a little over an hour.
44 2021-01-17 numbness 30 minutes after I was given the vaccine I felt my left temple become warm and then numb. 40 minute... Read more
30 minutes after I was given the vaccine I felt my left temple become warm and then numb. 40 minutes after receiving the vaccine my left cheekbone and left jaw felt numb, like I had a Novocain shot from the dentist.
44 2021-01-17 migraine Migraine started 2 days after first dose, came back worse 3 days after dose
44 2021-01-17 pain in extremity Axilla on right side is swollen with enlarged lymph nodes, redness, warm to touch, and painful.
44 2021-01-17 tingling Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis ... Read more
Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis on arms and rash erupted - fine; erythema, warmth, HR 8, R 18, Pulse ox 97%, lungs clear. At 11:45, she noted tingling of the tongue, but no enlargement. Benadryl 25mg given PO at this time. At 12:00, she noted fingers tingling. At 12:20: HR 98, pulseox 97%. At 12:25: Rash, pruritis on right leg just below knees and behind the left knee.
44 2021-01-18 numbness, pain in extremity Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fev... Read more
Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fever; Headache; really sore right arm; right arm felt numb; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (Pfizer COVD 19 vaccine), lot number: EL0142, via an unspecified route of administration on 07Jan2021 17:00 at single dose in right arm for COVID-19 immunisation. Medical history included blood pressure abnormal, had a cough from having COVID 19 on 16Dec2020, cough was ongoing and unknown for COVID-19. Concomitant medication included amlodipine from an unspecified date (taking for 2 years) and ongoing at 10mg once daily by mouth for blood pressure abnormal. No other vaccines were administered on same date and no prior vaccinations (within 4 weeks). Registered nurse (patient) was calling regarding Pfizer COVID 19 vaccine. Reported she received the first dose last Wednesday 07Jan2021 17:00 in the right arm. Reported she noticed the next day (08Jan2021) fever and a headache. On 08Jan2021, Friday she had a really sore right arm and her right arm felt numb. On 09Jan2021, Saturday, she experienced nausea and vomiting and also noticed a rash on her right arm, like a hive or whelp. On 10Jan2021 Sunday, again with the fever, nausea, vomiting and she had diarrhea. Today she stated she woke up a new woman. She feels felt with no fever and her arm was better. She still had a cough from having COVID 19 on 16Dec2020. Stated she was used to coughing. Added she treated the fever with Tylenol 1000mg. Stated she didn't remember exactly but she took a little everyday starting on Thursday the day after the vaccine. Stated she was unsure if she would have the next dose. The events didn't require a visit to physician office or emergency room. The outcome of fever was recovered on 10Jan2021, of Headache, sore arm, rash on right arm, nausea and vomiting was recovered on 11Jan2021, of arm numb was recovered on 09Jan2021, of diarrhea was recovering. Serious criteria for fever was reported as yes, medical significant, for Headache, sore arm, arm numb and Diarrhea was non-serious, for rash on right arm, nausea and vomiting was unspecified.; Sender's Comments: Based on the compatible time association, the event fever is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-01-18 muscle spasms headache, fever, muscle pain, spasms. called in sick to work.
44 2021-01-18 tremor tachycardia which continues to persist; intermittent violent shaking; This is a spontaneous report f... Read more
tachycardia which continues to persist; intermittent violent shaking; This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Eh9899, expiry date: unknown, vaccine location: left arm, dose number: 1), via an unspecified route of administration on 21Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included dermatomyositis (not receiving any treatment). The patient had no known allergies. The patient's concomitant medications were not reported. Shortly after vaccination on 24Dec2020, the patient developed tachycardia which continues to persist. Also, on 24Dec2020, the patient developed intermittent violent shaking. Treatment was received for the adverse events. EKG and lab work were done. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. The events did not result in death, were not life-threatening, did not cause or prolong hospitalization, were not disabling or incapacitating, and did not result to a congenital anomaly or birth defect. Outcome of the events was not recovered.
44 2021-01-19 migraine migraine, fever, sweat, body aches, vomiting
44 2021-01-19 pain in extremity Headache, pain in left arm, fever, chills, body aches, nauseous, fatigue
44 2021-01-19 seizure Systemic: Anaphylaxis, Systemic: Seizure-Severe
44 2021-01-20 numbness facial numbness that started on her cheek, nose, and neck; This is a spontaneous report from a conta... Read more
facial numbness that started on her cheek, nose, and neck; This is a spontaneous report from a contactable pharmacist. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (pending clarification) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that within 10 minutes of administration, the patient experienced facial numbness that started on her cheek, nose, and neck. Three weeks later, she still has the numbness. The patient has reported improvement, but it has not been totally resolved. The patient described it as receiving a shot of Novocaine from the dentist but does not describe the sensation of paralysis or bell's palsy. The reporter asked whether or not the patient should receive the second dose of the vaccine after experiencing this side effect. Her 3-week mark was on Friday, in which she has missed her second dose (pending clarification). The patient received an unspecified treatment for the event. The outcome of event was recovering. Information on the lot/batch number has been requested.
44 2021-01-20 tremor body pain; rapid onset of fever (within 30 min 101.7); skin sensitivity; cough; itchy throat; violen... Read more
body pain; rapid onset of fever (within 30 min 101.7); skin sensitivity; cough; itchy throat; violent episodes of shaking and chills for 36 hours; violent episodes of shaking and chills for 36 hours; increased urination/diuresis; This is a spontaneous report received from a contactable nurse (who is also the patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in left arm, on 09Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. The patient medical history was not reported. The patient is not pregnant. The patient had no other medications in two weeks. The patient did not have COVID-19 prior to vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in right arm, on 22Dec2020 12:00, at single dose, for COVID-19 immunization. The patient experienced body pain, rapid onset of fever (within 30 min. 101.7, as reported), skin sensitivity, cough, itchy throat, violent episodes of shaking and chills for 36 hours and increased urination/diuresis all on 09Jan2021 at 22:15. No treatment was received for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events body pain, rapid onset of fever (within 30 min 101.7), skin sensitivity, cough, itchy throat and increased urination/diuresis was recovered on unspecified dates; and the outcome of violent episodes of shaking and chills for 36 hours was recovered on 11Jan2021 at 08:15. Information on the lot/batch number has been requested.
44 2021-01-21 weakness COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchines... Read more
COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.
44 2021-01-21 flushing Started with flushing. Recieved 25mg Bendaryl po, which did not seem to help. progressed to nausea, ... Read more
Started with flushing. Recieved 25mg Bendaryl po, which did not seem to help. progressed to nausea, some SOB, received epi, then started to break out. Prepare to take to BMC. Another dose of epi was given prior to transport. BP 176/106 HR 84 P 22
44 2021-01-21 grand mal seizure Two grand mal seizures and went unconscious. Prior to seizures felt very lethargic.
44 2021-01-21 pain in extremity, discomfort Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye... Read more
Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye bloody Abdominal pain for 3 days unable to sleep due to discomfort Nausea off and on for 3 days with abdominal pain Fatigue Faint with abdominal pain Light headed off and on
44 2021-01-21 pain in extremity I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my... Read more
I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my left arm all the way to the finger was swollen. I had pain in the wrist arm, joints and fingers. I determined it was due to the swelling. I had some lymph node enlargement, and was really fatigue and slept most of the day. (36 hours). I did not have a fever. I'm a doctor and did some evaluations on myself. I didn't have trouble breathing of swallowing. If I wasn't medically trained I would have gone into the doctor. I did see an ENT for hearing test to make sure there was no damage and there was not.
44 2021-01-21 tingling, numbness Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "c... Read more
Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "code called" -- pt. given epi, oxygen, transferred to ED.
44 2021-01-21 seizure I believe that I had a seizure lasting about 30 seconds or so
44 2021-01-22 flushing Racing heart, dizzy, flushed face, headache
44 2021-01-22 pain in extremity arm soreness then on 1/22 fever of 100.7 and headache.
44 2021-01-23 feeling cold Fever, chills, muscle aches, fatigue, headache
44 2021-01-24 weakness Decreased range of motion and pain same day as administration. Pain resolves after 1 week. 3 weeks p... Read more
Decreased range of motion and pain same day as administration. Pain resolves after 1 week. 3 weeks post administration, range of motion is still decreased and weakness in that arm. Patient referred to specialized medicine.
44 2021-01-24 discomfort Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short dur... Read more
Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short duration), slight lymph node enlargement in neck, tiredness, aches and discomfort, "flu-like" lasted approx. 30 hours
44 2021-01-24 slurring Lower extremity weakness, dysarthria, presyncope
44 2021-01-24 flushing Patient stated "throat feels funny" and felt generalized flushing. Treated with benadryl 25 mg PO a... Read more
Patient stated "throat feels funny" and felt generalized flushing. Treated with benadryl 25 mg PO and observed 30 minutes with improvement of symptoms.
44 2021-01-24 night sweats Couldn't walk; Terrible body aches; Every joint was aching; Mild, headache; Cold with chills; Cold w... Read more
Couldn't walk; Terrible body aches; Every joint was aching; Mild, headache; Cold with chills; Cold with chills/ Was shivering; Fever; Sweating all night; This is a spontaneous report from a contactable nurse. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 31Dec2020 10:02 at a SINGLE DOSE for covid-19 immunisation. Medical history included tuberculosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took BCG vaccine. The patient received Pfizer COVID Vaccine on 31Dec2020. On 04Jan2021, the patient got a couple of symptoms and started with a mild headache, not sharp pain and she took Tylenol. After she showered when she came home from work, she got chills. She took a couple more Tylenol, but doesn't know when. When she went to bed, she sweated all night and still feel cold with chills and was sweating all night. She didn't really check temperature, but knew she had a fever. On 05Jan2021, she woke up and felt like someone had hit her from her head to toes and every joint was aching, terrible body aches and couldn't walk. She went to emergency room on 05Jan2021 and thought she may have been exposed a couple of days before. She was working with patients who had COVID. She had a rapid COVID test that was negative and came home and symptoms continued. Today was the first day she was feeling a little better. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of mild, headache, cold with chills, cold with chills/ was shivering, fever, sweating all night , couldn't walk, terrible body aches, every joint was aching. The outcome of the events was unknown. Information was requested on Lot/ Batch number.
44 2021-01-24 pain in extremity very low grade fever; it was 99.5 degrees Fahrenheit; getting a GI cold; Arm pain; General fatigue; ... Read more
very low grade fever; it was 99.5 degrees Fahrenheit; getting a GI cold; Arm pain; General fatigue; This is a spontaneous report from a contactable nurse, reporting for herself. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the left arm on 17Dec2020 at single dose for COVID-19 vaccination. Vaccination was done in a hospital. Medical history included celiac disease from 2011 and ongoing (very well controlled, she eats gluten-free. This is an autoimmune disease, but she is not immunocompromised like they ask with the Pfizer COVID-19 Vaccine. She is typically very healthy) and irritable bowel syndrome from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that following the first dose, she just experienced arm pain and general fatigue, just the basics. Arm pain and general fatigue with first dose she described as she did not really have a negative effect from; just the basics what everyone was saying. She did not feel anything when the first dose was injected; she did not have any issues until about 3 hours later that day on 17Dec2020 when she had onset of arm pain and general fatigue where she just felt tired for a few days; nothing big; she was able to work after the first dose; she just took ibuprofen for the first 2 days and the arm pain went away. She also mentioned that before getting the second dose of the vaccine she had a very low grade fever; it was 99.5 degrees Fahrenheit but she felt fine. Her stomach she was kind of having a little issue with loose stools for a few days before the second dose of the vaccine. She had celiac disease and a history of irritable bowel syndrome; and her uncle died on 02Jan2021 so she blamed the symptoms going on stress due to that. She does not know if maybe she was getting a GI cold at that time, the symptoms were a little mild before getting the second dose of the vaccine, she never felt sick or anything like that. She told the doctor about these symptoms during her appointment on 06Jan2021. Seriousness criteria of very low grade fever and a little issue with loose stools unknown. The patient underwent lab tests and procedures which included body temperature: 99.5 degrees fahrenheit on an unspecified date and COVID-19 test: negative on 06Jan2021. The outcome of the events was unknown. The reporter assessed the events arm pain and general fatigue as related to BNT162B2.
44 2021-01-24 tingling After patient received vaccine she C/O tingling face was given Benadryl @1341 , 15 minutes later pa... Read more
After patient received vaccine she C/O tingling face was given Benadryl @1341 , 15 minutes later patient was C/O tight throat, Solumedrol 60mg IM administered to Rt buttocks by this nurse. Pt then escorted to ER for further evaluation. On 1/25/21 at 1359: Patient reported tingling of lips and throat felt tight. SPO2 via finger with a result of 99%. Emergency room provider's note: 44-year-old female patient presents ED after allergic reaction. Patient received her first COVID-19 vaccination and during the 15-minute observation period began to feel as if she had some tightness in her throat and difficulty swallowing. She has a scratchy sensation to her posterior pharynx. She denies specifically shortness of breath, nausea vomiting, dizziness or near syncope. She was medicated with 50 mg of Benadryl p.o. as well as 60 mg of Solu-Medrol IM prior to arrival. She states she has never previously had allergic reactions to vaccinations in the past
44 2021-01-24 tremor, pain in extremity 1 pm was vaccine admin time on Wed (1/20). By 8 pm, her arm was very sore & with significant fatigue... Read more
1 pm was vaccine admin time on Wed (1/20). By 8 pm, her arm was very sore & with significant fatigue. 1am that night, awoke with chills, fever (102), generalized muscle aches. By midday Thursday, these symptoms began to dissipate slightly and she developed a h/a. Friday, fever, chills, h/a were gone & nausea and abdominal pain started. No vomiting or diarrhea occurred. By SAturday evening, nausea improved but upper legs became tremulous and weak. Weak, tremulous legs have continued and persist up until today (monday, 1/25).
44 2021-01-24 trigeminal neuralgia The day after the first shot, I got a severe headache and felt very tired. I don't normally get hea... Read more
The day after the first shot, I got a severe headache and felt very tired. I don't normally get headaches or feel tired, but I was aware that they can be side effects of the vaccine. I have trigeminal neuralgia type II, which causes facial pain headaches, but this was not that type of headache. Since getting the first shot, I have had at least 5 trigeminal neuralgia headaches when I normally only have 1 per month if that. I take Amitriptyline 150 mg nightly to regulate my trigeminal neuralgia and have not had any changes to my dosage or medication in several years. I am concerned because I read (unfortunately after having the shot) that PEG's are in the vaccine and also in Amitriptyline and am wondering if the vaccine has caused my trigeminal neuralgia flare ups. It has taken me several years to finally find the right medication to regulate my trigeminal neuralgia, and I am hoping the vaccine hasn't set me back. I had been hesitant to have the vaccine, but I work in an emergency department and felt obligated to do so. I wish I had consulted my neurologist or another health care provider of mine before having the shot. I am due for my second shot on 1/28/21, and I will still have it.
44 2021-01-25 weakness 7pm-Dizziness, weakness, tiredness, chills. 1/26-530am - Chills, body aches, slight fever -101.0, he... Read more
7pm-Dizziness, weakness, tiredness, chills. 1/26-530am - Chills, body aches, slight fever -101.0, headaches, dizziness,
44 2021-01-25 weakness I started running a mild fever the next day and I still have a fever today; feel lightheaded; weak; ... Read more
I started running a mild fever the next day and I still have a fever today; feel lightheaded; weak; feeling nausea; my legs were weak; my throat got tight; This is a spontaneous report from a contactable HCP. This 44-year-old female (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm at single dose for COVID-19 immunization on 08Jan2021 05:30 PM. Relevant medical history included osteoporosis and menopause. Known allergies included: soy, dairy, all nuts, sunflower, cottonwood, lentils, chickpeas, Vit E, cephalexin, Amoxicillin, sulfa, Bactrim, lisinopril , estrogen, moxifloxacin, Pseudoephedrine, paroxetine, trimethoprim, doxycycline, azithromycin, cipro, clindamycin, colestipol. The patient was not pregnant. Relevant concomitant drug included Vit D, calcium, ibuprofen. Five minutes after receiving the vaccine, her throat got tight then she started to feel lightheaded and her legs were weak. She notified the staff there who offered her Benadryl but she declined. She began feeling nausea about an hour later and she felt lightheaded and weak for about 4 hours. She started running a mild fever the next day and she still had a fever on 12Jan2021. The patient did not receive other vaccine in four weeks. The outcome of events was recovering. No treatment was received. The patient was not COVID infected prior vaccination. The patient did not have COVID tested post vaccination.
44 2021-01-25 cold sweat Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizzines... Read more
Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizziness and blurred vision. Patient was walking at the time and was then sat down. Patient was clammy and diaphoretic, blood pressure was elevated from her normal and O2 was normal. Patient reported feeling a thickness in her throat, similar to mucus but no trouble breathing. Ambulance was called and she was taken to the ER by paramedics, was not able to stand to get on stretcher and was helped on by paramedics.
44 2021-01-25 cold sweat Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision.... Read more
Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision. Patient almost fell while walking and was sat down. Patient was clammy and diaphoretic and blood pressure was elevated from her normal but O2 was normal. No swelling but patient reported drainage in her throat, a thick mucus like feeling. Ambulance was called and patient was taken away on stretcher, was not able to stand to get on stretcher.
44 2021-01-25 tingling Patient presented with possible allergic reaction described as feeling "tingles everywhere" and "wei... Read more
Patient presented with possible allergic reaction described as feeling "tingles everywhere" and "weird taste" in mouth. The symptoms began about 15 minutes ago after receiving the Pfizer COVID vaccine dose #1 Patient was treated with Benadryl, Solu-medrol and NS 1L bolus. Symptoms improved. Normal lung sounds. No signs of further reaction
44 2021-01-25 tingling Tingling sensation all over the body. Pins and needle sensation all over the body. Parestheshia of a... Read more
Tingling sensation all over the body. Pins and needle sensation all over the body. Parestheshia of all extremities . Abdominal pain, chills/rigors
44 2021-01-26 feeling cold, numbness feeling cold/coldness; increased temperature/she took her temperature and it was 100.2/fever; body n... Read more
feeling cold/coldness; increased temperature/she took her temperature and it was 100.2/fever; body numbness/body started to feel numb; This is a spontaneous report from a contactable nurse reported for herself. A 44-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular at left deltoid on 13Jan2021 16:00 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient historic vaccine included the first dose of BNT162B2 on 22Dec2020 for covid-19 immunization. The patient body started to feel numb on 13Jan2021, she was feeling cold/coldness on 14Jan2021, increased temperature on 14Jan2021 and she took her temperature and it was 100.2, stated that she knew that a fever is a side effect. She was only concerned with the body numbness and wanted to know if body numbness was anything to be concerned about. The reporter assessed events was related to Pfizer Covid vaccine and as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible temporal association, the Company considers the reported events of hypoesthesia, pyrexia and feeling cold are possibly related to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-01-26 feeling hot, flushing Observed for 30 minutes. Flushing, arm heaviness reported, nausea, heat in thighs. Reports similar ... Read more
Observed for 30 minutes. Flushing, arm heaviness reported, nausea, heat in thighs. Reports similar reaction with first dose. Requested to rest on a stretcher. BP 140/71, HR 93. Nausea and arm heaviness reported at 1605. BP 150/81, 10015sats; HR 87. At 1610 Heat in thighs. BP 125/66, HR 82 100% sats on oxygen. 1628: No further symptoms. Released home.
44 2021-01-26 flushing, feeling hot Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing... Read more
Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing in her ears, tension in her neck and arm in the left side where she received the vaccine. Took her pulse and lay her on a cot, gave her water. After about 20 minutes of rest, she felt well enough to drive home.
44 2021-01-26 flushing Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat... Read more
Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat/chest, flushed skin and tachycardia after. Received Antihistamines, Albuterol treatment and steroid for treatment.
44 2021-01-26 pain in extremity Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial... Read more
Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial redness, left chest wall swelling and tenderness. Seen Dr today
44 2021-01-27 numbness, inability to speak on the evening of 1/11/21 pt started to talk to her children and she "could not access the words." T... Read more
on the evening of 1/11/21 pt started to talk to her children and she "could not access the words." Then she tried to text and couldn't figure out the vocabulary. She went to the ER where she was transported to hospital, under stroke protocol. She also c/o right hand numbness at the er. She was admitted and test run. No evidence of a stroke.
44 2021-01-27 muscle spasms her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; T... Read more
her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; Tiredness; scratchy throat which got worse with time; tenderness around the injection site; it felt really bad almost like a flu; it felt really bad almost like a flu; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: 30Apr2021, NDC number: 59267100001), intramuscular in the left deltoid, on 08Jan2021, at 0.3 mL, single, for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported she had side effects after receiving the first dose (Jan2021). She had a scratchy throat which got worse with time. She had a general muscle ache, tenderness around the injection site. The muscle ache increased with chills and low grade fever. She said it felt really bad almost like a flu. She reported her eye is still swollen with chills and low grade fever. She further clarified that she was given the vaccine on 08Jan2021, Friday afternoon. On 09Jan2021, Saturday, she had muscle aches, tiredness, and by Saturday night she had a scratchy throat. On 10Jan2021, Sunday, she experienced tiredness and muscle cramps. She worked half day on 11Jan2021, Monday, and by the afternoon she had chills and low grade fever. On 12Jan2021, Tuesday morning, she woke up and her eyes were swollen. She noticed the swelling has decreased a little bit. She didn't have any symptoms such as difficulty breathing. The reporter asked what have caused these side effects and why did her immune response react this way after receiving the vaccine. She mentioned that her second dose is set up for the end of January and asked if she will be able to get the second dose since she had a reaction and she was wondering if had an illness when she got the vaccine could that have caused her to have a hyper response in her immune system to the vaccine. The outcome of the events scratchy throat which got worse with time, general muscle ache, tiredness, muscle cramps, eye swelling and low grade fever was recovering; chills was not recovered; and the outcome of the remaining events was unknown.
44 2021-01-27 numbness and pain in extremities, tingling Arm neuropathy and tingling, warmth in the injection site
44 2021-01-27 pain in extremity, inability to speak body aches, sore arm, stomach ache, lost her voice. Symptoms lasted for 2 days.
44 2021-01-27 pain in extremity, feeling hot I was just hot, I got hot; Hands started hurting; Really bad headache; Feeling kind of boozy; This i... Read more
I was just hot, I got hot; Hands started hurting; Really bad headache; Feeling kind of boozy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included high blood pressure and diabetic. Concomitant medications included lisinopril for high blood pressure, metformin for diabetes, and amlodipine. Today (11Jan2021), the patient just got hot and her hands started hurting. She was just feeling kind of boozy. She really had a bad headache. The patient was thinking why the lady didn't ask her if she was taking any medication or anything, she just asked if the patient was allergic to anything. The patient was not allergic to anything but she was taking medications. The patient asked if she should go and take her medication for tonight or hold until her symptoms go away. No treatment was received for the adverse events. The patient just lied down and have been sleeping for two hours. Outcome of the events was unknown.
44 2021-01-27 pain in extremity, flushing 40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to ... Read more
40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to forehead, to right ear and to right side neck, followed by sudden throat dryness. BP 165/122, HR 120, Pts normal BP 90-100 systolic 80's diastolic, Hr usually 80's. about 1 hr later mild headache, left arm soreness. 2nd day after sensation of palpitations, day 3 sensation of palpitations, HR 108 on one measurement.
44 2021-01-27 pain in extremity Starting the day after the vaccine she had body aches, sore arm, stomach ache and lost her voice. Sy... Read more
Starting the day after the vaccine she had body aches, sore arm, stomach ache and lost her voice. Symptoms lasted 2 days.
44 2021-01-27 pain in extremity Sore arm for a couple days
44 2021-01-28 weakness Had the common side effects: headaches, fevers up to 101.5, severe body aches, fatigue in the the mo... Read more
Had the common side effects: headaches, fevers up to 101.5, severe body aches, fatigue in the the morning after the shot, but also had concurrent severe vomiting and nausea. Vomited approximately 20 times day after the vaccine, starting about 18 hours after the vaccine. Other symptoms were present about 13-14 hours after the vaccine. Vomited continued for 14 hours. Severe nausea continued for 2-2.5 days. No diarrhea. No abdominal pain. Too weak to drive to the ER. Had Zofran at home and took 8 mg of Zofran ODT every 4-6 hours for 36 hours beginning with the onset of vomiting. Missed 3 days of work but was able to orally rehydrate.
44 2021-01-28 numbness Some numbness in left portion of face, namely forehead down to jaw along hairline. Lasted close to t... Read more
Some numbness in left portion of face, namely forehead down to jaw along hairline. Lasted close to three hours, and has not happened since.No treatment.
44 2021-01-28 pain in extremity, tenderness The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hou... Read more
The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hours of injection, could not touch my arm. The pain radiates from the shoulder to finger tips with sharp shooting, stabbing pains at times. A lot of pressure. There is a burning feeling from my shoulder to finger tips. By the end of day on 01/18/2021, I had decreased range of motion in my arm, it is difficult and very painful to try and extend my arm out to the side, which continues to today 01/29/2021.. My entire arm is still tender and sore, tricep, bicep, and shoulder. It is difficult to sleep and work due to the pain.
44 2021-01-28 pain in extremity This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient r... Read more
This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received first dose of bnt162b2 ( COVID-19 VACCINE; lot EK9231, expiration date unspecified), via an unspecified route of administration on 08Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included mild sleep apnea. The patient had no known allergies. The patient was not pregnant. There were no concomitant medications. On 09Jan2021, the patient experienced injection site pain and arm soreness on day 1 and day 2, patient was also very tired on day 1. Patient also had occasional sneezing and mild headache since day 1. On day 2, energy level was back to normal. However, on 11Jan2021, on day 3, the patient started to develop occasional shortness of breath and continued today, day 7. The shortness of breath comes and goes. On 14Jan2021, on day 6, the patient experienced occasional coughing and continued today, day 7. Since the patient was working in a pharmacy, she cannot rule out if symptoms were from vaccine or Covid exposure, so patient decided to get Covid test done today, day 7. The patient had no treatment received for the events. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. Patient had no Covid prior vaccination and was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with pending results on 14Jan2021. Outcome of events was not recovered.
44 2021-01-28 tingling Right after the shot I had itching, tingling, and red spots all down my arm, then my throat swelled ... Read more
Right after the shot I had itching, tingling, and red spots all down my arm, then my throat swelled a bit and I became sweaty. Nurse checked my blood pressure and it was very high for me (144/83) usually 117/78. Nurse administered one Benadryl tablet and I felt better within about 15 minutes. Now I just feel very tired.
44 2021-01-29 feeling cold At around 530 pm Friday I had extreme tiredness, felt feverish, was freezing. Took advil and laid o... Read more
At around 530 pm Friday I had extreme tiredness, felt feverish, was freezing. Took advil and laid on couch. Fell asleep, per family hallucinated. About 1 to 2 hours later I could not smell.
44 2021-01-31 numbness 10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN ca... Read more
10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN came to assist. 10:04am Benadryl 25 mg liquid given PO BP121/73 P 104 PO 97%. Left arm injection site asymptomatic. Pt states this is her 2nd Covid vaccine and did not react to the first one. Pt states she had anaphylactic reactions to PCN, ASA, Sulfa, Keflex and Codeine in the past. C/O blurred vision. 10:10am BP 132/81 p 112 PO 98% with same symptoms. RN present and we discussed going to ER, vs stable and patient declined going. 10:15am BP 133/82 P-114 PO 96%, pt states her breathing is better, thinks the Benadryl caused the dizziness, continued blurred/fuzzy vision, not double vision, A & O x3. 10:20am BP 127/83 P-108 PO98% denies SOB and chest tightness, states she feels better. Crackers, juice and water given. 10:25am BP 123/83 P 105 PO 98% pt states blurred vision has gone. 10:30am BP 129/70 P 105 PO 97% continue to feel better. Talking to her co-worker about getting a ride back to work with her after she receives her vaccine. 10:55am BP 120/72 P 105 Sat 99% went to restroom with another nurse and states she feels fine standing. 11am BP 126/75 P98 PO 98% denies arm numbness, blurred vision and SOB/chest tightness. Report off to 11am Volunteer RN for the monitor room.
44 2021-01-31 numbness diminished sensation on the lateral aspect of left leg from knee below and whole left foot/felt numb... Read more
diminished sensation on the lateral aspect of left leg from knee below and whole left foot/felt numbness on left leg; This is a spontaneous report from a contactable Other healthcare professional (patient). A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 14Jan2021 10:30 at single dose in Left arm for COVID-19 immunization. Medical history included hypertension, covid prior to vaccination. Concomitant drug included unspecified products which the patient received in two weeks. There were no other vaccines received in four weeks. The patient previously took cefalexin monohydrate (KEFLEX) and experienced allergies. The patient did not have COVID tested post vaccination. Approximately 10 hours after the patient got the vaccine on 14Jan2021 21:00, she felt numbness on her left leg. It got worse this afternoon so she left work to go to urgent care. She had diminished sensation on the lateral aspect of her left leg from knee below and her whole left foot on 14Jan2021 21:00. The reported adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of events 'diminished sensation on the lateral aspect of left leg from knee below and whole left foot', 'felt numbness on left leg'. The patient underwent lab tests which included blood works with unknown result on an unspecified date. The outcome of the event was recovering.
44 2021-01-31 pain in extremity Headache, Fevers , Body aches, Nausea, Arm Pain
44 2021-01-31 tremor Soreness at injection site within 1 hour. Swelling at injection site within 1 hour pain and swelling... Read more
Soreness at injection site within 1 hour. Swelling at injection site within 1 hour pain and swelling continued until Thursday (4 days later). Feeling ?off? or unwell without any other symptoms -3 hours after injection and lasted until 5:00pm next day when symptoms increased. Starting 5:45pm Lethargy, shaking all over, feeling of ?freezing ?, upset stomach, fever of 101- continued into the evening. Fever resolved with Advil and rest. Shaking and upset stomach stopped sometime overnight. Feeling very tired next day.
44 2021-02-01 feeling hot, facial paralysis right after the vaccine my whole arm got hot and traveled to the top half of body. I felt hot right... Read more
right after the vaccine my whole arm got hot and traveled to the top half of body. I felt hot right away , during the day I felt my left eye a bit droppy and pain to the injection site by the end of that day I had chills, next day chills , nauseated, tired, slight cough and still felt my left eye droppy , next day slight sorethroat and by the next day I was good.
44 2021-02-01 migraine Migraine that was so sever just moving my head would make me cry or cause me to throw up. Extreme n... Read more
Migraine that was so sever just moving my head would make me cry or cause me to throw up. Extreme nausea and chills Lasted for one day
44 2021-02-01 pain in extremity Report right arm pain, cough and chest tightness. Treatment: None. Outcome: Arm pain resolved, cough... Read more
Report right arm pain, cough and chest tightness. Treatment: None. Outcome: Arm pain resolved, cough and chest tightness continues.
44 2021-02-01 tremor chills with shaking; chills with shaking; joint pain; muscle pain; fatigue; swelling at injection si... Read more
chills with shaking; chills with shaking; joint pain; muscle pain; fatigue; swelling at injection site; pain at injection site; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EA9899, via an unspecified route of administration on Arm Left from 19Jan2021 08:15 to 19Jan2021 08:15 as single dose for COVID-19 immunisation. The patient took first dose of the BNT162B2 vaccine on an unspecified date. Medical history included asthma, penicillin (PCN) allergy, environmental allergies, and major depression. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), and lamotrigine (LAMICTAL). On 19Jan2021 20:00, the patient experienced chills with shaking, joint pain, muscle pain, fatigue, swelling at injection site, and pain at injection site. The outcome of the events was recovering. Prior to vaccination and since the vaccination, was the patient was not diagnosed with COVID-19. No treatment was received for the events.
44 2021-02-02 migraine Migraine (two days), vomitting (one day), headache (three days), chills (one day), body aches (three... Read more
Migraine (two days), vomitting (one day), headache (three days), chills (one day), body aches (three days), and fatigue (three days).
44 2021-02-02 migraine Migraine with nausea, sensitivity to light and sound for 10 days that is only minimally lessened wit... Read more
Migraine with nausea, sensitivity to light and sound for 10 days that is only minimally lessened with 12-16 Motrin daily. Had injection of Toradol and started imitrex this morning after going to my doctor, but still no change.
44 2021-02-02 tingling Pt received Pfizer dose #1 and was stable/asymptomatic after 15min monitoring period. she reports on... Read more
Pt received Pfizer dose #1 and was stable/asymptomatic after 15min monitoring period. she reports on the way to her car she began to feel tingling on the left side of her neck that radiated to the jaw/cheek/lower eye on the left. VSS on check x2. Case discussed with doctor and Pt deemed stable to DC home
44 2021-02-03 feeling of body temperature change Light headache & injection area soreness at 2pm 10pm started to notice some aches. Midnight (14 ho... Read more
Light headache & injection area soreness at 2pm 10pm started to notice some aches. Midnight (14 hours post injection) awakened by intense headache, severe body aches, sweating, hot and cold. Extreme fatigue. In bed & slept all day. 8:30pm still have headache, fatigue & light body aches.
44 2021-02-03 numbness numbness on her temple, which moved down to her left cheek on her ear area. She also said that the s... Read more
numbness on her temple, which moved down to her left cheek on her ear area. She also said that the side of her face feels numb; This is a spontaneous report from a contactable consumer reporting for self. This 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249) on 18Jan2021 09:00 at single dose (Anatomical location: upper left arm) for COVID-19 immunisation. Medical history included penicillin allergic when she was a teenager, and allergic to cephlasporins. Ongoing concomitant medications included omeprazole, vitamin d nos (VITAMIN D) and birth control pills. No additional vaccines administered on same date of the BNT162B2. No prior vaccinations within 4 weeks. Patient said she had a reaction to the 1st dose of the vaccine. She said that she felt fine in first 15 minutes after the vaccine, about 30 minutes later, she experienced numbness on her temple, which moved down to her left cheek on her ear area. She also said that the side of her face felt numb, facial numbness on left side of her face but no paralysis. She stated she was able to move her face. The event onset time reported as 09:40 on 18Jan2021. Stated it felt like she went to the dentist and got a numbing shot like it was starting to wear off. Patient wanted to know if that is a typical reaction, and if it is related to Bell's palsy. Treatment was received for the event, patient just took Turmeri 1 table. No hospitalization involved, the event did not require a visit to emergency room or physician office. The outcome of event was recovering.
44 2021-02-03 pain in extremity Arm mildly sore evening after vax but no other symptoms. Following morning, started have mild muscle... Read more
Arm mildly sore evening after vax but no other symptoms. Following morning, started have mild muscle aches and fever. Tylenol kept fever down to around 100.5. By the evening, I had 103.2 temp even while taken tylenol and was advised by on-call RN to alternate tylenol and motrin for 3 hours until it decreased. Fever came down after 2-3 hours to 102.3. Fever down to 101.5 by next morning. Had mild headache, dizzyness and fever for next several days.
44 2021-02-04 weakness 1/30 08:00 Severe chills, weakness, fever. Slept for approx. 10 hrs. Symptoms began to ease in the e... Read more
1/30 08:00 Severe chills, weakness, fever. Slept for approx. 10 hrs. Symptoms began to ease in the evening with full recovery to baseline 1/31. 2/1 05:00 Upon waking, I noticed I could feel cold sores beginning on my lips. I occasionally experience A SINGLE cold sore after extreme exposure to elements, but not usually after illness. This morning I could feel MANY cold sore forming on my lips (top and bottom) as well as insides of my cheeks and gums. I can count at least 15 different sores that all came on simultaneously. Treating sores as usual with frankincense and balm to reduce cracking and bleeding. Sores taking usual clinical course, not healed yet.
44 2021-02-04 feeling hot Immediate itching at site which spread to generalized body; Immediate itching at site which spread t... Read more
Immediate itching at site which spread to generalized body; Immediate itching at site which spread to generalized body; Red rash and warmth to entire upper arm; Red rash and warmth to entire upper arm; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284), via an unspecified route of administration on 02Jan2021 07:00 AM at single dose on left arm for COVID-19 immunization. COVID-19 vaccine was administered in the hospital. Patient is not pregnant. Medical history included hypothyroid. No other vaccines within 4 weeks prior to COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included thyroid (ARMOUR THYROID), prednisone, famotidine (PEPCID) and fexofenadine hydrochloride (ALLEGRA). The patient previously took influenza vaccine, azithromycin and monistat, and experienced allergies to all. Patient was not diagnosed with COVID-19 prior vaccination. The patient experienced immediate itching at site which spread to generalized body. Patient also experienced red rash and warmth to entire upper arm. All events occurred on 02Jan2021 07:15 AM. No treatment was given for the events. Events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.
44 2021-02-04 muscle spasms Nausea immediately after injection, joint and muscle pain, sharp back spasms shortly , site soreness... Read more
Nausea immediately after injection, joint and muscle pain, sharp back spasms shortly , site soreness, mild headache
44 2021-02-04 pain in extremity, weakness was always in the bed not wanting to do anything; Weakness; tired; Chills; sore arm; Swollen arm; Jo... Read more
was always in the bed not wanting to do anything; Weakness; tired; Chills; sore arm; Swollen arm; Joint pain; Muscle pain; she was severely sick for 11 days; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020 0930 at a single dose on the right arm for COVID-19 immunization. Medical history included ongoing cholesterol problems from 2019 (manages without medication) and colitis. Concomitant medications were not reported. The patient previously took doxycycline from Aug2020 to 30Dec2020 for colitis. The patient experienced muscle pain, joint pain, sore arm and swollen arm on 31Dec2020. She experienced weakness, tired, chills on 01Jan2021, and was always in the bed not wanting to do anything on an unspecified date. The patient stated she was severely sick for 11 days and stated her covid and flu test came back negative. She said she could not work and was off work due to the side effects. She had to go to urgent care also. She wanted to know about taking the second dose. She was scheduled to get her second dose on 22Jan2021. She was sick with the first dose. She was weak, tired, had chills and was always in bed not wanting to do anything. She asked if these events will come back with the second dose and if it is possible to not get the second dose. She also reported that her arm was sore. She had joint and muscle pain. She tried to fight it. The weakness and chills continued off and on. She returned to work on 12Jan2021. She went to the urgent care and has also went to see her physician. She had lab work done. She also had a rapid Covid and flu test, both of which were negative. Outcome of weakness and chills was recovering; outcome of sore arm and swollen arm was recovered on 04Jan2021; outcome of joint pain and muscle pain was recovered on 12Jan2021; outcome of tired was not recovered; outcome of "she was severely sick for 11 days" was recovered on an unspecified date; outcome of "always in bed not wanting to do anything" was unknown. Information about batch/lot number has been requested.
44 2021-02-04 pain in extremity It began with right arm soreness and progressed to aches and low grade fever within the first 24 hou... Read more
It began with right arm soreness and progressed to aches and low grade fever within the first 24 hours. Then it moved on to mid-sternal chest pain that radiated to my back and I had shortness of breath that increased with deep breathing after about 48 hours.
44 2021-02-04 pain in extremity Stayed home with fever and body aches first day. Second day radiating pain in arm, back, left should... Read more
Stayed home with fever and body aches first day. Second day radiating pain in arm, back, left shoulder, arm pit and under rib cage. Itching and could not sleep. Can touch, turn or sleep on her left side.
44 2021-02-04 tingling 2 weeks after vaccination, increasing tingling in right arm radiating to back and sometimes to lower... Read more
2 weeks after vaccination, increasing tingling in right arm radiating to back and sometimes to lower extremity. Intermittent dizziness. Symptoms are persistent, worsening and not relieved.
44 2021-02-04 unresponsive to stimuli 15 min after vaccine administered patient stated she had a frontal headache radiating to her right s... Read more
15 min after vaccine administered patient stated she had a frontal headache radiating to her right side of head and tinglinig around her lips. She was instructed to stay for an additional 15 min for observation. She was placed on a stretcher to lie down. She was conversing and her S/S went unchanged. At approx 1 pm she became unresponsive, she did not wake with touch or verbal command Her eyelids were fluttering as if she was experiencing a seizure. A condition was called. Pulse ox 100 % blood sugar 90. Monitor NSR. She remained unresponsive and was taken to the ED. Upon arrival to the ED at approx 1:17 pm, the ED nurse stated she was awake. Evaluated by physician, labs and CT head ordered. Patient stated all lab work and CT scan was normal. Employee was discharged with a diagnosis of vasovagal near syncope.
44 2021-02-05 numbness, pain in extremity At 7pm, i experienced chills, shivering, head fuzziness, muscle aches and right arm pain. At 9pm, ex... Read more
At 7pm, i experienced chills, shivering, head fuzziness, muscle aches and right arm pain. At 9pm, experienced fever, headache and numbness in my finger tips. Took ibuprofen 600mg. Did not see any improvement for an hour. Went to bed at 12:30. Awoke at 3am with same symptoms. Took ibuprofen 600mg at 6am. Symptoms came back 1:30pm that day. Took another ibuprofen 600mg. The rest of the evening was good except for a headache.
44 2021-02-05 tingling Patient stated feeling lightheaded and tingling sensation on left leg after receiving second dose of... Read more
Patient stated feeling lightheaded and tingling sensation on left leg after receiving second dose of Pfizer Covid vaccine. Client was sitting on waiting area post vaccine for 15 minutes. EMT responded and alerted lead RN. Vitals taken at 1310: blood pressure 116/82, pulse 72, oxygen 99. Alert and oriented, stated symptoms began after vaccine. No prior history of tingling sensation in extremities. Stated tingling on left leg, mobility intact, no radiation or pain past leg. Allergies to amoxicillin and no current medications. Client given water and instructed to drink small sips. Per client no breakfast this morning and had two cups of coffee. Client denied chest pain, shortness of breath, palpitations, vision changes, headache. RN client asked to stay under observation longer and that EMT would recheck vitals prior to her leaving. EMT reassessed at 1325. Per client feeling better, was returning to work after leaving facility. Instructed to get food and rest. Last set of vitals: blood pressure 120/80, pulse 62, oxygen 99. Client left facility with a steady gait.
44 2021-02-06 numbness, tingling 1408 Numbness and tingling of bilateral cheeks and swelling of fingers. Denies SOB, dysphagia,cough,... Read more
1408 Numbness and tingling of bilateral cheeks and swelling of fingers. Denies SOB, dysphagia,cough,diziness,syncope,Vital 120/82,82,96%. Given Benadryl 50mg po. 1419 Reports symptoms calming down less sensation of swelling and calming down. 1433 spoke with husband and notified of situation. 1515 Patient exited in stable condition. Agreed and understands of what to do if symptoms worsen or continue.
44 2021-02-06 tingling, numbness About a half hour after receiving my second vaccine shot I began to feel tingling and numbness on th... Read more
About a half hour after receiving my second vaccine shot I began to feel tingling and numbness on the right side of my face. The sensation was located under my cheekbone and expanded to my jaw. It gradually spread to my chin and lips. It lasted for approximately four hours. When I woke up the next morning it was gone. The day after the vaccine I had more common side effects.
44 2021-02-07 flushing, weakness Feeling ichy/unwell within 2-3 minutes post vaccination. Feeling dizzy and weak, flushed skin, overw... Read more
Feeling ichy/unwell within 2-3 minutes post vaccination. Feeling dizzy and weak, flushed skin, overwhelming fatigue, out of it. Administered lactated ringer and famotidine Potential vasovagal response. Felt improved within 2.5 hours 48 hours later began abdominal pain (7/10) and diarrhea lasting 36 hours, with diminishing severity of pain and volume of diarrhea; mild nausea without vomiting. Treatment includes Allegra every 12 hours and Naproxen Sodium.
44 2021-02-07 numbness, tremor Friday 7:30 nausea- took zofran sublingual. 7:30-3pm headache , runny rose, body ache, shakiness, w... Read more
Friday 7:30 nausea- took zofran sublingual. 7:30-3pm headache , runny rose, body ache, shakiness, watery eyes. 3-6pm felt recovering. Friday 9pm-Sunday 4pm abd pain got added to the mix with bloating and abd distension. Friday?s symptoms lessen. Took meds and alkaline products to balanced things out. Ate bread crackers constantly to help with acid buildup and damage of mucosal lining. Protonix 40mdg only alleviate pain for 30 minutes. Could not sleep for over 24 hrs. Pale white stool. Axillary lymph nodes pain. Monday and pain better. Felt lethargy and numbness to hand and feet. Mild Headache still persist.
44 2021-02-07 tingling Client reports tingling in arms, face, hands down to feet and felt lightheaded and dizzy. Client rep... Read more
Client reports tingling in arms, face, hands down to feet and felt lightheaded and dizzy. Client reports lasting about an hour, increased then plateaued and then decreased with taking Benadryl. Similar circumstances with first vaccination lasting approximately 1.5 hours. Increased heart rate and increase blood pressure during both circumstances.
44 2021-02-08 breast pain Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle... Read more
Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle aches (whole body) Debilitating headache Pain and swelling at injection site (right arm) Painful joints *Safe dose range of OTC Tylenol ineffective Ongoing effects (onset approximately 24 hours after first vaccine): Painful lump right breast/armpit
44 2021-02-08 electric shock sensation, tingling, numbness, weakness Started with headaches on 4th day out from vaccine. By that Sunday I was lethargic, had pains throug... Read more
Started with headaches on 4th day out from vaccine. By that Sunday I was lethargic, had pains throughout my body, zaps of pain, inflammed joints, anxiety, Stomach/acid reflux, Pains/aches in body - short temporary pains, Electrical like pulses of pain in head left front side mainly, also in right hand, felt weak - no energy, Legs felt a bit numb or tingly, hips and lower back feel tender, knees too
44 2021-02-08 flushing Moderate to severe myalgias, arthralgias, & headache (HA) started 1/21/21 ~16hrs after 2nd vaccine d... Read more
Moderate to severe myalgias, arthralgias, & headache (HA) started 1/21/21 ~16hrs after 2nd vaccine dose. (Had mild-mod HA after 1st dose 12/30/20 which resolved after ~10days, with persistent neck/facial flushing & chills that decreased in frequency). Myalgias & arthralgias resolved ~4 - 5 days later, flushing/chills & HA continued, though severity lessened. Attempted return to work Wed 1/27 but severe HA w nausea began while driving. HA continued but decreased to mild ~1/31, and returned to work Wed 2/3 (reg sched is Wed-Fri, 3 x 12.5hrs). Mid morning Thurs 2/4 at work severe HA & nausea returned, had to leave work. Mod-sev HA continues 2/9/21, 20days after vaccine #2, and not cleared to return to work.
44 2021-02-09 difficulty speaking Severe myalgias started during sleep the night of the vaccine administration. Next day myalgias per... Read more
Severe myalgias started during sleep the night of the vaccine administration. Next day myalgias persisted & worsened and brain fog started (difficulty/inability to perform ADLs, memory lapse, difficulty thinking, concentrating, forming sentences, functioning very slow, etc). Throughout the day severe headache set in, myalgias persisted and brain fog worsened. By 8-9pm symptoms were extreme, took about 1000mg of expired Children's Tylenol. By 11pm myalgias improved. Slept through night. Next morning all symptoms had resolved.
44 2021-02-09 feeling hot, pain in extremity warm sensation; anxiety; sore arm; This is a spontaneous report from a contactable consumer, reporti... Read more
warm sensation; anxiety; sore arm; This is a spontaneous report from a contactable consumer, reporting for herself. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration at the right arm on 23Jan2021 17:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. On 23Jan2021 17:30, the patient experienced warm sensation, anxiety and sore arm. No treatment was received. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date. Information on the batch/lot number has been requested.
44 2021-02-09 feeling hot 2:50 C/o"dizzy and hot" 2:52 drank H2) and put feet up on chair for light headedness 2:58 Lips pink,... Read more
2:50 C/o"dizzy and hot" 2:52 drank H2) and put feet up on chair for light headedness 2:58 Lips pink, nailbeds <3 sec cap refill, texting on phone no new c/o 3:03 unchanged 3:04 improved 3:05 VS 124/78, p 80, pO2 98% RA 3:20 reported symptoms resolved and comfortable to leave. Advised if light headed in hall to sit and call for help. Left with steady gate.
44 2021-02-09 flushing fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. b... Read more
fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. bp 129/93 heart rate 115. Headache with flush face and arms and legs super heavy feeling on Sunday. Tuesday night experienced facial and head swelling, started in the middle of my forehead gradually filling up my entire head and face. Wednesday my whole face/eyes and head swollen, with tightness on my chest. My primary care provider prescribed methylprednisolone tablets USP Dosepak 4mg. I did take Benadryl and tylenol Tuesday. I also applied ice packs to my head and face. Headache still comes and goes with brain fog. Slight swelling remains on my forehead and eyes.
44 2021-02-09 pain in extremity, breast pain chills; headache; feeling sore in her arm; tiredness; she was also breastfeeding; she was also breas... Read more
chills; headache; feeling sore in her arm; tiredness; she was also breastfeeding; she was also breastfeeding; itching/itching was worse on her chest and back/allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area; was breastfeeding; it was full of milk that also hurts very bad; allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area; on her back as well; allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area; on her back as well; feeling unwell; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration on 21Jan2021 (lot number and expiry date unknown) at single dose for Covid-19 immunization. The patient stated "just to protect myself". Medical history included blood pressure high, lost weight because she was breastfeeding now (ongoing). Concomitant medication included labetalol from unspecified date for blood pressure high, and blood pressure medicine. Historical vaccine included first dose of BNT162B2 on 31Dec2020 for Covid-19 immunization and experienced allergy. The patient informed that she already reported to a pharmacist. The female patient received the second dose of the COVID vaccine on Thursday (21Jan2021). The patient informed that she was fine the same day she received the vaccine and had some itching (21Jan2021), but the next day (22Jan2021) she had a headache and was feeling sore in her arm. The patient experienced a little bit sore in her arm, bad sore on her arm; after she had the first one maybe after a day, but it was not that bad. The patient informed that she received the covid vaccine on Thursday (21Jan2021) and has been feeling unwell ever since (Jan2021). The first day it was okay, she meant a little bit sore in her arm, her sore arm. On Friday (22Jan2021), she started like having tiredness, headache, and sore like bad sore on her arm. Then now she has seen, she said it was okay then she knew because there was a side effect so she tried to take rest and drink water. What happened was, now (Jan2021) on her body it looked like some kind of allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area and she was a breastfeeding mom and on her back as well. The patient informed that after 3rd day (Jan2021) it got like especially on her breast area and her chest area got like itchy. Today (24Jan2021), the headache came back, and she was experiencing chills and her itching was worse on her chest and back. The patient informed that she was also breastfeeding. The patient wanted to know what she was supposed to do. The patient informed that she has headache, the headache was back today, now when she woke up, she has headache. The patient was asking for guidance if she was breastfeeding and has received the second dose of the COVID vaccine. The patient informed that she was to feed her son, because she didn't feed him yesterday, so it was full of milk that also hurts very bad. The patient was scared, because it was itchy area on her breast, so she was scared to breastfeed her son. The patient informed that it was like back and forth, but now this morning (Jan2021) the patient has headache, yesterday (Jan2021) she was okay. The patient informed that about her treatment, she didn't take even a painkiller; she just only took her blood pressure medicine. The outcome of the event headache was not recovered, while itching/itching was worse on her chest and back/allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area, feeling sore in her arm, feeling unwell, tiredness, allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area; on her back as well, chills, was breastfeeding; it was full of milk that also hurts very bad was unknown. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092765 baby case
44 2021-02-09 pain in extremity I went to sleep for four hours when I woke up I had a hard time walking. My legs were sore for abou... Read more
I went to sleep for four hours when I woke up I had a hard time walking. My legs were sore for about 24-36 hours. I was very tired for about 7 days all I did was sleep.
44 2021-02-09 tingling Systemic: Other- approx. 48 hrs. post 2nd vax on 2/1/21, patient exp in L (dominant) arm generalized... Read more
Systemic: Other- approx. 48 hrs. post 2nd vax on 2/1/21, patient exp in L (dominant) arm generalized hypothesia in L wrist & parathesia L hand & fingers. Moved to R hand on 2/4/21 less pronounced. Lasted 2 days
44 2021-02-10 bell's palsy Right eye doesn't close all the way when blinking or closing symptoms started 2/6/21 also couldn't k... Read more
Right eye doesn't close all the way when blinking or closing symptoms started 2/6/21 also couldn't keep mouth closed shut tight to swish after brushing teeth same night. Headache above right eye, right ear pain and right side neck pain all starting 2/6/21 morning. Had televisit on 2/8/21 who advised me to be further checked out. At the er they did an head ct without contrast which was normal did a neuro exam and determined I had bell's palsey. Prescribed prednisone 20 mg tid x 7 days and valacyclovir 1 gm tid x 7 days. They also advised to tape my eye shut when sleeping. My eye hurts when I drive or focus on pc or tv so I had to miss 2 days of work thus far.
44 2021-02-10 feeling hot, facial paralysis On 2/3, 2 hours after vaccine, I experienced extreme heat to my face. (The feeling I get when I?m g... Read more
On 2/3, 2 hours after vaccine, I experienced extreme heat to my face. (The feeling I get when I?m going into anaphylaxis) but anaphylaxis never came. It dissipated after a couple of minutes, but red face and ears all day. On the 7th, I started noticing partial paralysis on the right hand side of my face. It is still there. I have not been around anyone outside of my home since March 2019 nor have those who live with me. The only exception has been when I got my two vaccine doses.
44 2021-02-10 pain in extremity, burning sensation Left arm shoulder pain and severe nausea began about 12 hours afer vaccine and lasted for approx ano... Read more
Left arm shoulder pain and severe nausea began about 12 hours afer vaccine and lasted for approx another 16 hours; Left arm shoulder pain and severe nausea began about 12 hours afer vaccine and lasted for approx another 16 hours; Severe Burning from neck, through arm, and down side immediately after injection lasting about 20 minutes; Left arm shoulder pain and severe nausea began about 12 hours afer vaccine and lasted for approx another 16 hours; This is a spontaneous report from a contactable other health care professional, the patient. A non-pregnant 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1283), intramuscular in the left arm on 20Jan2021 at 09:30 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included hydroxyzine pamoate and multivitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 09:30 AM, the patient experienced severe burning from neck, through arm, and down side immediately after injection lasting about 20 minutes. Left arm shoulder pain and severe nausea began about 12 hours after vaccine and lasted for approximately another 16 hours. The events were reported as non-serious. The patient did not receive any treatment for the events. The clinical outcome of severe burning from neck, through arm, and down side immediately after injection lasting about 20 minutes, Left arm shoulder pain and severe nausea began about 12 hours after vaccine and lasted for approximately another 16 hours was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
44 2021-02-10 pain in extremity headache, sore arm, and swollen node(s) in the armpit of the same arm
44 2021-02-10 tingling Tingle to face started about 4 hours after dose, was ongoing a few hours then off and in for 1-2 day... Read more
Tingle to face started about 4 hours after dose, was ongoing a few hours then off and in for 1-2 days. Extremely tired with brain fog started evening of second shot and has been ongoing. Just starting to improve after 4 weeks.
44 2021-02-10 tremor, migraine Symptoms came on suddenly around 3:00 am on 02/09/2021 with migraine headache, shaking chills, extre... Read more
Symptoms came on suddenly around 3:00 am on 02/09/2021 with migraine headache, shaking chills, extreme body aches, fever as high as 102, nausea, abdominal cramps, and exhaustion lasting about 48 hrs. Then lesser symptoms and a lower temp another 12 hrs., with a normal temperature by 7:00 pm on 02/11/2021. Also, I'm not sure if this is related at all but thought it was worth mentioning, while washing my hair on 02/11/2021,a lot more hair than usual came out.
44 2021-02-11 weakness Within 15 minutes I started getting lightheaded and sweaty. I called nurse over and told her I need... Read more
Within 15 minutes I started getting lightheaded and sweaty. I called nurse over and told her I needed to lie down. She pointed to the gurney but it was too far away and I was too weak so she had me out my head between my knees. Another nurse brought me a bottled water and pack of crackers. I drank the water slowly and started feeling better after 30 minutes.
44 2021-02-11 numbness, hypersensitivity of all senses Vaccination between 1:00 PM Five minutes after was itchy, numb, swelling up tongue 50 Mg Benadryl,... Read more
Vaccination between 1:00 PM Five minutes after was itchy, numb, swelling up tongue 50 Mg Benadryl, itchy to left hand, back head, and neck forty to fifty minutes. Take a dose of Benadryl around 8:00 pm . Itching lasted a week. Scratched the right lower leg and this created a raised bruise to that was sensitive to touch and lasted a week.
44 2021-02-11 muscle spasms Fever, muscle cramping, headaches
44 2021-02-11 tremor Severe redness, rash, swelling, headache, nausea, muscle weakness and aches, joint pain, shakes
44 2021-02-12 tingling Tingly sensation in both arms and slow and heavy breathing. Mask and morning exertion could have be... Read more
Tingly sensation in both arms and slow and heavy breathing. Mask and morning exertion could have been a cause of the slow and heavy breathing. Tingly sensation went away quickly. The breathing issues resolved after inhaler was used and the patient drank some water.
44 2021-02-14 flushing, tingling Pt began to feel "hot, warm, and tingling through her mid section chest / stomach area, skin and che... Read more
Pt began to feel "hot, warm, and tingling through her mid section chest / stomach area, skin and chest and arms red and flushed. VS @1222 BP 176/80, HR 86, O2 99%. @ 1232, feels better, Vitals recheck @ 1238 BP 140/78, HR 92, O2 99%.
44 2021-02-14 pain in extremity Splitting headache, sinus pressure, 102.3 degree fever, body aches, chills, sore throat, runny nose,... Read more
Splitting headache, sinus pressure, 102.3 degree fever, body aches, chills, sore throat, runny nose, sore arm, fatigue. Took Advil at 7:00 PM on 2/14/21 because I couldn?t tolerate the pain anymore. It is 11:30 AM on 2/15/21 and still fatigued, aches, chills, and headache.
44 2021-02-14 pain in extremity Pain started slowly after shot and within a couple of hours the pain was in the entire arm, I could ... Read more
Pain started slowly after shot and within a couple of hours the pain was in the entire arm, I could not lift my arm up. I also felt very tired and sleepy. I took some acetaminophen twice (650mg) and was much better within 24h. The next day, the pain in the arm went away pretty quickly and I wasn't feeling so tired anymore.
44 2021-02-14 pain in extremity Sore right underarm and right side of neck. Swollen lymph nodes right underarm, upper chest on righ... Read more
Sore right underarm and right side of neck. Swollen lymph nodes right underarm, upper chest on right side and right side of neck in front.
44 2021-02-15 pain in extremity NIGHT OF VACCINATION, DEVELOPED ARM PAIN, CHILLS, BODY ACHES, AND HEADACHE LASTING 24 HOURS.
44 2021-02-16 muscle twitching within 15 minutes of Pfizer vaccine had itchy arms and facial twitching. She was observed for an hou... Read more
within 15 minutes of Pfizer vaccine had itchy arms and facial twitching. She was observed for an hour and was told to take benadryl as needed after leaving. Noticed facial rash later that night. The next day patient was itchy in both arms and has some facial swelling, does not have any trouble breathing. was taking benadryl every 4 hours, seen by allergist next day for telemedicine visit and was advised to switch to cetirizine, max 2 tab bid.
44 2021-02-17 breast pain my left breast started draining clear/white fluid; there is associated pain radiating down towards t... Read more
my left breast started draining clear/white fluid; there is associated pain radiating down towards the nipple from the top of the breast and along the left side of the breast; This is a spontaneous report from a contactable nurse who reported for herself This 44-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# EL3247 in the left arm on 19Jan2021 at SINGLE DOSE for covid-19 immunization . Facility where the most recent COVID-19 vaccine was administered:Workplace clinic.Age at vaccination 44 years.The patient received the first dose of the same vaccine from Lot # EL1284 on 29Dec2020 via intramuscular , on the Left arm .Tthe patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypothyroidism , gestational diabetes ,Allergies: Bees (anaphylaxis) , Allergy: shrimp (gastrointestinal) .Concomitant medication included levothyroxine , alprazolam , procaterol hydrochloride (PRO-AIR), chlorphenamine maleate (CHLOR) and vitamin d . The patient reported as follows :"On 22Jan2021 18:00 my left breast started draining clear/white fluid. Additionally there was associated pain radiating down towards the nipple from the top of the breast and along the left side of the breast that has lasted two weeks and continues".Lab data included mammogram (2021): unknown results .ultrasound left breast (2021): unknown results.The adverse event result in Doctor or other healthcare professional office/clinic visit.Events were treated (I have had to have a mammogram and ultrasound of left breast and am awaiting an MRI.Levaquin ).Events reported as non serious.Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.Outcome of the events was not recovered.
44 2021-02-17 feeling jittery, coordination abnormal, involuntary muscle movements, weakness, inability to speak, numbness The evening of her vaccine she developed jittery feeling (worse than having too much caffeine), felt... Read more
The evening of her vaccine she developed jittery feeling (worse than having too much caffeine), felt like her muscles were jerking, feeling unbalanced and uncoordinated (almost fell on stairs) due to vertigo sensation and whole body weakness. A feeling of being both "drunk and high". Word finding has been harder, but this is part of her baseline. Some numbness into left hand, 4th and 5th digits only.
44 2021-02-17 numbness Arm burning, swelling of throat, facial numbness, dizziness, hives
44 2021-02-18 flushing, tingling Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine, ... Read more
Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine, developed palpitations, chest pressure, feeling flushed and anxious, nausea, tingling on left side of body and face, elevated blood pressure, and slight dizziness while driving home. Was seen at ER a few hours later; cardiac workup was done with CXR, bloodwork, EKG and heart monitoring and was treated with Benadryl IV. Was sent home for 2 days out of work and instructed to take Benadryl as needed.
44 2021-02-18 tingling s/p injection c/o tingling left side of neck, jaw, and below eye. Resolved with no intervention
44 2021-02-20 numbness and pain in extremities, weakness, pain in extremity Severe headache x 2 weeks, neuropathy in bilateral upper and lower limbs, feeling unwell a general m... Read more
Severe headache x 2 weeks, neuropathy in bilateral upper and lower limbs, feeling unwell a general malaise, weakness, tiredness, sharp pains in my legs and head, dizziness, off balance, all lasting for about 2 weeks or so is when I started to get relief I still have a lingering headache and neuropathy.
44 2021-02-21 facial paralysis, inability to speak, face paralysis I started feeling really tired (couldn't move type tired). I called off worked for few days. On the ... Read more
I started feeling really tired (couldn't move type tired). I called off worked for few days. On the 1/7 noticed right of my face was drooping about 10 days couldn't smile and wiggle both ears.For me to talk it was very difficult due to right side of my face being so weak. I went to walk in clinic was diagnosed with Bell's Palsy. As of today I still couldn't lift my eyebrow (right) and smile still slightly cooked.
44 2021-02-21 numbness About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that... Read more
About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that way for several hours. 2 days later my arm felt like someone was hitting it over and over with a needle. I had numbing pain in my shoulder and back. I felt nauseated. It has been over a week and I still have pain at the injection site and have body aches. I am unsure who to contact and am not sure what I should do.
44 2021-02-21 migraine, weakness Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migrai... Read more
Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migraine, shortness of breath, ear pain
44 2021-02-21 pain in extremity Day 1 - pain in arm where shot was administered. Day 2 - 4 - pain down arm concentrated in left arm... Read more
Day 1 - pain in arm where shot was administered. Day 2 - 4 - pain down arm concentrated in left arm-pit, area surrounding arm-pit and left wrist and top of hand.
44 2021-02-21 tenderness, pain in extremity Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed... Read more
Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed swelling in my right breast and lymph nodes in my right armpit. It is painful to the touch and swollen to the size larger than a golf ball. Pain radiates down my inner arm to my forearm.
44 2021-02-22 weakness Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; Th... Read more
Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
44 2021-02-22 pain in extremity I was given my 2nd dose of Covid-19 vaccine on 10 Feb 2021 at about 0800 am, I stayed at the facilit... Read more
I was given my 2nd dose of Covid-19 vaccine on 10 Feb 2021 at about 0800 am, I stayed at the facility for 15 minutes and did not have any issues at that time. My arm was a bit sore and I felt tired for a couple days following the 2nd vaccine. On 12 Feb early afternoon (around 1100am), I noticed I was dizzy and feeling a bit nauseated like I had motion sickness. I already had the following week off work, so I napped when I could. I have been tired as well. I have been experiencing waves of dizziness daily now since 12 Feb (today marks the 12th day). I spoke with my PCM's team at the Spokane VAMC and they recommended I try to take Meclizine at night to see if I improve. I was advised to have someone drive me to urgent care if my condition worsens where I lose consciousness, faint, or cannot stand up straight.
44 2021-02-23 flushing Patient reported metallic taste in mouth feeling flushing in throat and chest. HR 113, 96% o2 RA was... Read more
Patient reported metallic taste in mouth feeling flushing in throat and chest. HR 113, 96% o2 RA was checked by paramedics and cleared refused treatment.
44 2021-02-23 numbness Per vaccine clinic recovery RN notes: "Patient was sent to ER (in front of vaccine clinic) for evalu... Read more
Per vaccine clinic recovery RN notes: "Patient was sent to ER (in front of vaccine clinic) for evaluation with c/o numbness of the right side of the face. States sudden onset and increasingly numb, and worse than after the first covid vaccination. States last time, numbness subsided within 1 hour and no further symptoms. Patient tolerated walking across parking lot to the ED, registration without problems."
44 2021-02-23 pain in extremity, feeling hot Enlarged painful lymph nodes on right side neck and body under arm. Hot arm, diarrhea, extreme fati... Read more
Enlarged painful lymph nodes on right side neck and body under arm. Hot arm, diarrhea, extreme fatigue, headache. My neck and underarm are still achy and enlarged. My body is still sore and I have not been able to continue with my daily activities. I have not felt like this since I had mono as a 19 year old. I have 5 children and have gone through natural childbirth 3 times. I?ve received all my vaccinations faithfully and have never in my life reacted this way. I am not getting the second dose until I have blood work done to see how my high my antibody levels are. I respect and am grateful for your work However I need to see data on my body?s reaction to even consider getting another dose.
44 2021-02-23 pain in extremity 2/22 body aches, fever, rigors, fatigue 2/23 R axillary lymphadenopathy, pain in axilla, shoulder an... Read more
2/22 body aches, fever, rigors, fatigue 2/23 R axillary lymphadenopathy, pain in axilla, shoulder and arm, fever, fatigue, myalgias 2/24 low grade fever, otherwise same as 2/23
44 2021-02-23 tingling, numbness, feeling cold Patient complained of numbness/tingling of hands & feet, pale face and feeling cold with heart racin... Read more
Patient complained of numbness/tingling of hands & feet, pale face and feeling cold with heart racing.
44 2021-02-24 weakness Chills, Muscular pain, Fever, Headache, Weakness.
44 2021-02-24 numbness, tingling Initial symptoms numbeness and tingleness in mouth anf face; hour after vaccine both hands dark blue
44 2021-02-25 migraine Development of herpes zoster in T1 dermatome, migraine headache
44 2021-02-25 pain in extremity Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contac... Read more
Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contactable 44-year-old female consumer (patient). A 44-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 14Jan2021 at 10:00 AM (at the age of 44 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included allergy to codeine, was diagnosed with COVID-19 prior to vaccination and had BNT162B2 vaccine dose 1 on unknown date, lot unknown. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications was not provided. The patient did not receive any other vaccines within 4 weeks or any medications within 2 weeks prior to the COVID vaccine. On 16Jan2021, at 08:00 AM, the patient experienced sore arm, sore neck and swollen lymph node under my left arm. No treatment was received for the events sore arm, sore neck and swollen lymph node under my left arm. The outcome of the events sore arm, sore neck and swollen lymph node under my left arm was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
44 2021-02-25 tingling, feeling hot, pain in extremity, feeling of insects crawling on skin About an hour after the injection, it felt like someone was injecting the right side of my brain wit... Read more
About an hour after the injection, it felt like someone was injecting the right side of my brain with warm saline. Then I had a dull headache in that same area fir three days. Also, 18 hours after receiving the second dose, I experienced what felt like hot, electric bugs crawling throughout my hands and feet. My feet also felt very weak, like they couldn?t hold my body weight. This lasted for about 24 hours, and then resolved. I still occasionally experience the pins and needles sensation in my feet on and off. I also experienced the more common side effects, such as headache, extreme fatigue, muscle aches, and sore arm.
44 2021-02-26 feeling hot The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, ther... Read more
The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, there were halos on the lights, itchy eyes, itchy throat, and her body felt warmer. She had an increased blo0od pressure of 150/100mmHg.
44 2021-02-26 flushing, tremor Palpitations, flushing, dizziness, shaky, chills, evaluated by EMS-cleared
44 2021-02-27 numbness, hot flush Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes ... Read more
Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes 10 minutes after injection Chest pain and tightness 15 minutes after injection Brain fog delayed movement thyroid meds left my system 20 minutes after injection
44 2021-02-27 pain in extremity Arm soreness - ensuing 36 hours Fatigue - ensuing 36 hours Vertigo (mild) - onset 4 days after the v... Read more
Arm soreness - ensuing 36 hours Fatigue - ensuing 36 hours Vertigo (mild) - onset 4 days after the vaccine, ongoing for 5 days
44 2021-02-28 cold sweat Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the... Read more
Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the bath tub. Didn?t take temperature until 9:00am 100.9. Husband gave me Advil & Tylenol. Stomach ache/nausea came next, didn?t feel like eating. Very painful back ache shortly after that. Temperature kept fluctuating all day (due to Tylenol use). The next day (today 3-1-2021), I felt better, so I went to work. I noticed all day I getting the cold sweats. I was clammy most of the day, but didn?t feel tired. Took temperature after someone noticed I looked pale at work. My temp was 99.7. At around 4:30 I noticed my left armpit was hurting. Went home at 5:30 and relaxed. I told my husband my armpit was hurting around 10:30pm, I decided to Take my temp at 11:15pm and it was 97.6. I will see if the adverse side affects go away after today.
44 2021-02-28 discomfort Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin... Read more
Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
44 2021-02-28 feeling hot Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with ton... Read more
Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with tongue that felt thick or swollen. Then the next am woke up with aches, headache, chills, hot (suspected fever but did not get up and check) tiredness. Spit up yellow fluid (thought it might be from GERD) and laided around all day. Did not eat as stomach felt nauseated. At 3 pm I ate half a sandwich and at 4 ate half a banana and drank some water and 1/4 of cup of sweet tea. By 6pm I was really sick to my stomach got up and threw up sandwich and banana. I thought I saw some blood but was not sure. I continued to throw up and it became all blood (bright red) mixed with water. This occured twice and then I called doctors office and the dr on call advised me to go to ER since urgent cares were closed. I went to ER about 8:30pm with continued headache, nausea, lightheadedness. I tried to tell ER dr that I was there mainly for throwing up blood. I sat in waiting room. ER dr saw me at 3am and gave me Zofran for nausea as i thought I was going to be sick and gave me EKG, Blood panel and Blood Pressure readings. Told me I was mildly dehydrated. My BP was higher than I think I have ever seen it.
44 2021-02-28 muscle twitching 01.20.21-01.27.21: headache and fatigue daily 01.22.21: dizziness and right sided facial twitching a... Read more
01.20.21-01.27.21: headache and fatigue daily 01.22.21: dizziness and right sided facial twitching along the mandibular branch of the facial nerve. This lasted ~ 4 hours 01.26.21: fever 99.2, nausea & dry heaving, left sided ear and throat pain, coughing, body aches, fatigue. These symptoms lasted ~ 12 hours
44 2021-02-28 tingling One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell.... Read more
One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell. The swelling lasted for 4 hours. 16 hours after the vaccine I had a fever of 101 degrees Fahrenheit, chills, muscle aches, a headache, and I was vomiting. This lasted for 36 hours.
44 2021-02-28 tingling 1 minute after receiving the vaccine my face and tongue began to tingle. The tingling lasted 3 hour... Read more
1 minute after receiving the vaccine my face and tongue began to tingle. The tingling lasted 3 hours. 30 minutes after receiving the vaccine I felt confused and in a fog. That lasted 2 days. The following morning I also had flu like symptoms. Those lasted 24 hours.
44 2021-03-02 weakness, burning sensation Within minutes, Xavier felt burning sensation but did not report it while she was in the observation... Read more
Within minutes, Xavier felt burning sensation but did not report it while she was in the observation room because she thought it will go away just like it did with first dose. She then started to have rashes, low grade fever, and felt weak same day, and went on the following day. On 2/21/21 she had generalized swelling and rashes, difficulty breathing and went to the hospital.
44 2021-03-02 feeling hot, tingling Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP... Read more
Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.
44 2021-03-02 mild one side paralysis, numbness Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double v... Read more
Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double vision.
44 2021-03-02 tremor, seizure Symptoms were: general allergic reaction with hives followed by a seizure and spontaneous recovery. ... Read more
Symptoms were: general allergic reaction with hives followed by a seizure and spontaneous recovery. Pt relates Seizure was consistent with her normal seizures but slightly worse. She had a seizure 1 week ago and has seizures in clusters, this was consistent with the waning period of the current cluster. Vital signs were (abnormal with tachycardia and hypertension on arrival to the ED). Exam was notable for neck pain. Patient was treated with Benadryl on scene and with Toradol and fluids in the ED and symptoms recovered but multiple shaking episodes characterized by patient as seizure. Patient was observed in the emergency department for an extended period.
44 2021-03-04 flushing Patient received the Covid-19 vaccine. She reports symptoms of flushing, swollen feeling in throat w... Read more
Patient received the Covid-19 vaccine. She reports symptoms of flushing, swollen feeling in throat with some difficulty swallowing. No difficulty breathing, no wheezing, etc. Symptoms quickly lessened in intensity with first set of vitals. Injection was given at 1443. I have observed patient from immunization given through 1605. Treatment/intervention 1500: BP 138/90 Pulse 94 SPO2 98% Respirations 20 Diphenhydramine 25 mg given - patient requests to receive. 1502: BP 128/90 Pulse 100 SPO2 96% 1506: BP 126/88 Pulse 96 SPO2 99% Respirations 16 Patient tolerated 8 oz water, swallowing Without difficulty, still feels strange feeling in throat but much improved. 1510: Patient states she is feeling "much better" and has called spouse for ride home. 1525: 2nd dose of Benadryl 25 mg given. Patient is feeling much better, throat swelling sensation decreased, face is pink, not flushed, swallowing well and tolerated second 8 oz water. Instructed to contact physician regarding reaction today. Instructed to call 911 if any symptoms recur, difficulties breathing, etc. 1605: Escorted to husbands car, states feels "good."
44 2021-03-04 migraine fever, muscles, joint, bone pains (severe), Vomiting x 1 day, with continuous gagging and vomiting d... Read more
fever, muscles, joint, bone pains (severe), Vomiting x 1 day, with continuous gagging and vomiting daily since then, migraine
44 2021-03-04 pain in extremity, involuntary muscle movements, numbness After two hours sore arm ... left side of face slightly numb proceeded by a sharp pain down leg foll... Read more
After two hours sore arm ... left side of face slightly numb proceeded by a sharp pain down leg following by an unnatural involuntary movement of toes for about 2 minutes sharp pain then stiffness and inability to move . Numbness followed by a release and weakness .
44 2021-03-04 tingling, numbness Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower l... Read more
Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower lip
44 2021-03-05 tingling Pt @ 14 weeks pregnant, hx of seasme allergy (food ingestion) mild, no anaphylaxis now got first cov... Read more
Pt @ 14 weeks pregnant, hx of seasme allergy (food ingestion) mild, no anaphylaxis now got first covid vaccination and had mild hand tingling, no CP, no SOB or throat swelling
44 2021-03-06 feeling hot, weakness Nausea, Weakness, Overheated, Lightheaded, Body Aches, Fever, Rash, Dizziness
44 2021-03-06 tingling, flushing nausea/ Dizziness with in 10 minutes of vaccine. Flushing and Tingling in face and upper extremities... Read more
nausea/ Dizziness with in 10 minutes of vaccine. Flushing and Tingling in face and upper extremities. Patient had Covid in November. She went home to rest after the vaccination.
44 2021-03-07 weakness After 10 minutes of my first dose vaccine, I began to experience chest pain and could not breathe. I... Read more
After 10 minutes of my first dose vaccine, I began to experience chest pain and could not breathe. I felt nauseated. My BP went up to 150 and staff was monitoring me, my normal BP is 90/110. After two hours I started to feel dizzy, nauseated and i was in the ER room for four hours. I felt like passing out, my BP was 169/69 and my heart rate was also high. Then I started to feel cold and began to shivering while an EKG was performed. My BP never went down. After one week and for four days I had fever and weakness to my body also from my knees down felt weakness. Also one week after my vaccine, my lymph nodes got swollen, left ear. I communicated these symptoms to my PCP of my reactions.
44 2021-03-07 hot flush generalized aches and pains; fatigue; head fog; hot and cold flashes; Nausea; vomiting; insomnia; Si... Read more
generalized aches and pains; fatigue; head fog; hot and cold flashes; Nausea; vomiting; insomnia; Site pain persisted; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265 and expiry date: unknown), via an unspecified route of administration on the right arm, 04Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included HTN and Asthma. Patient was not pregnant at the time of administration. Concomitant medication included Olmesartan, bupropion hydrochloride (WELLBUTRIN), loratadine and vitamins. The patient previously took sulfur and morphine and experienced allergies. Events began with insomnia the night of injection on 04Feb2021 23:00. The following morning of 05Feb2021, patient woke with generalized aches and pains, fatigue, head fog, and hot & cold flashes. She had nausea and vomiting midday. Symptoms resolved by second day on 05Feb2021 but site pain persisted on Feb2021. TYLENOL and ibuprofen were given as treatments for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination.
44 2021-03-07 pain in extremity Extremely sore arm for 3 days Nauseous for 4 days Lymph nodes under left arm swollen and very tender... Read more
Extremely sore arm for 3 days Nauseous for 4 days Lymph nodes under left arm swollen and very tender for 5 days
44 2021-03-08 feeling hot Hives, took Benadryl they went away. Fever, chills then really hot, super achy. This happened on Sat... Read more
Hives, took Benadryl they went away. Fever, chills then really hot, super achy. This happened on Saturdat around 515 then Sunday super achy, very tired, couldnt function or move. Monday still very achy still had fever. Tuesday felt better
44 2021-03-08 flushing Felt an immediate flush on face, face reddened across cheeks and nose. Later, after work, noted rash... Read more
Felt an immediate flush on face, face reddened across cheeks and nose. Later, after work, noted rash on arms, back was dark with lighter rash on stomach and chest
44 2021-03-09 flushing, weakness, feeling hot Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid hea... Read more
Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
44 2021-03-09 numbness Tingling in throat, numbness of ankle and toes
44 2021-03-09 migraine Moderate headache for two days following, then a full blown migraine in the early evening on second ... Read more
Moderate headache for two days following, then a full blown migraine in the early evening on second day after vaccination. Sore arm muscle at vaccination site for a day and half.
44 2021-03-09 pain in extremity persistent left arm pain. exam consistent with lateral epicondylitis
44 2021-03-09 tingling Pt. stated she started feeling tingling in her fingers 5 min. after getting vaccinated. The tinglin... Read more
Pt. stated she started feeling tingling in her fingers 5 min. after getting vaccinated. The tingling on her fingers went away but she started feeling tingling in her knees. Vital signs were taken. O2 sat 100%, BP 134/63, HR 86. Patient stated she was nervous when vaccinated, but the tingling was new. At 3:53 pm patient stated the tingling is going away on its own. At 4:01 pm she stated she was feeling ok and is ready to go home.
44 2021-03-10 weakness, tremor Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored ... Read more
Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.
44 2021-03-11 breast pain Developed significant lymphadenopathy L axilla, L clavicle area, L breast with L breast swelling (3 ... Read more
Developed significant lymphadenopathy L axilla, L clavicle area, L breast with L breast swelling (3 inch increase in chest circumference). Pain and tenderness.
44 2021-03-11 flushing dizziness on the verge of passing out; welts all over midsection from upper legs through hips and on... Read more
dizziness on the verge of passing out; welts all over midsection from upper legs through hips and onto torso lasting for weeks; Intense headache; dizziness on the verge of passing out; flushed face and ears; This is a spontaneous report from a non-contactable other healthcare professional. This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), dose 1, single dose via an intramuscular route of administration in the left arm on 10Feb2021 at 10:30 AM (at the age of 44- years-old) for COVID-19 vaccination. Medical history included complete thyroidectomy with neck dissection (removed lymph) for papillary thyroid cancer with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy and penicillin allergy. The patient was tested for COVID-19 on 14Aug2020 by nasal swab and was negative. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 at 10:30 AM, the patient experienced intense headache within 5 minutes, dizziness on the verge of passing out (waited in the lobby for 1 hour before leaving), flushed face and ears, headache for several days, welts all over midsection from upper legs through hips and onto torso lasting for weeks. The clinical outcome of headache, dizziness on the verge of passing out, flushed face and ears, headache and welts was unknown. No follow-up attempts are possible. No further information is expected.
44 2021-03-11 tingling Fatigue, tingling in lips, face, neck, hands. Dryness in lips and hands. Soreness at injection site.... Read more
Fatigue, tingling in lips, face, neck, hands. Dryness in lips and hands. Soreness at injection site. Temperature 99.8
44 2021-03-13 flushing, tingling, numbness flushing, tingling/numbness neck and face. Evaluated by EMS-Cleared
44 2021-03-13 tenderness, pain in extremity Woke up with sore upper right thigh Tuesday March 9. Very tender to the touch. Visited Dr. Wednesday... Read more
Woke up with sore upper right thigh Tuesday March 9. Very tender to the touch. Visited Dr. Wednesday March 10, ordered ultrasound which was completed on Thursday March 11 and diagnosed a superficial blood clot. Prescribed Xarelto 10mg.
44 2021-03-14 weakness First Vaccine Dose on 12/26/2020 felt extremely fatigued. After 2nd vaccine dose on 01/16/2021 devel... Read more
First Vaccine Dose on 12/26/2020 felt extremely fatigued. After 2nd vaccine dose on 01/16/2021 developed fever, chills, weakness, fatigue, body aches approximately 10 hours after received the 2nd dose. This all lasted about 24 hours. Then on 01/19/2021 which was the 2nd day of mine menstrual cycle, I had a very abnormal menstruation. I was passing "fist" size blood clots which made me very weak. this lasted again about 24 hours then it stopped. I had some labs drawn on 02/27/2021 which came back with very low Iron, Hematocrit and Hemoglobin levels. I usually do show signs of anemia in previous blood work but this time the levels dropped lower so i was referred to see a Hematologist.
44 2021-03-14 migraine migraine immediately after vaccine administration, pt self-medicated with home medicines, pt monitor... Read more
migraine immediately after vaccine administration, pt self-medicated with home medicines, pt monitored for 30 minutes with some resolution, pt would like to go home
44 2021-03-14 pain in extremity The day after receiving the vaccine I woke up with a lot of soreness in the arm of the injection sit... Read more
The day after receiving the vaccine I woke up with a lot of soreness in the arm of the injection site. I was tired and had some nausea that increased with activity. By early afternoon I was too tired to continue my daily activities and had to call out of work. Since receiving the vaccine, I have experienced fatigue and mild nausea daily that is only relieved by frequent rest.
44 2021-03-14 tingling PATIENT STATES HAS NAUSEA AND DIZZINESS ALONG WITH TINGLING SENSATION TO FACE AND LIPS. PULSE IS 100... Read more
PATIENT STATES HAS NAUSEA AND DIZZINESS ALONG WITH TINGLING SENSATION TO FACE AND LIPS. PULSE IS 100 AND REGULAR. PATIENT HAS NO SHORTNESS OF BREATH, NO RASH OR ITCHING. PATIENT WATCHED AND EXTRA 15 MINS BUT REFUSED TO GO FOR FURTHER TREATMENT.PATIENT INSTRUCTED TO FOLLOW UP WITH EMERGERGENY DEPARTMENT OR CLINIC IF HAD FURTHER NEDDS OR ISSUES DID NOT RESOLVE.
44 2021-03-15 breast pain Itching / Soreness of right breast. Started about 1 hour after vaccination and continued for approxi... Read more
Itching / Soreness of right breast. Started about 1 hour after vaccination and continued for approximately 48 hours.
44 2021-03-15 pain in extremity, tingling 6 hours in - very sore arm. 12 hours in - sore arm that required tylenol. 12-24 hours headaches, fat... Read more
6 hours in - very sore arm. 12 hours in - sore arm that required tylenol. 12-24 hours headaches, fatigue. 24 hours later - itchy throat/roof of mouth (took benadryl). 36-48 hours itchy throat/roof of mouth continued but became itchy on arms and legs. 2-4 days post vaccine it progressed to itchy spots on my entire body. No hives - but a rash and redness. Feels like pin and needles.
44 2021-03-15 pain in extremity After receiving my first dose I experienced the following adverse side effects: -Fatigue -Extreme so... Read more
After receiving my first dose I experienced the following adverse side effects: -Fatigue -Extreme soreness in my arm -The lymph nodes under my arm pit was swollen and tender -I broke out in hives on my hands and face -I had a rash on my tongue -A knot on the bottom of my right foot [in the area of the arch] -The skin on both of my hands have been peeling extremely bad
44 2021-03-16 pain in extremity Stomach upset, virus, and diarrhea. My right arm has a sharp pain from my neck down to my fingertips... Read more
Stomach upset, virus, and diarrhea. My right arm has a sharp pain from my neck down to my fingertips on a daily basis.
44 2021-03-17 feeling hot, bell's palsy Bell's palsy on right hand side of my face; extreme heat in my face; Red face and ears all day; Red ... Read more
Bell's palsy on right hand side of my face; extreme heat in my face; Red face and ears all day; Red face and ears all day; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at single dose in right arm for covid-19 immunisation at the age of 44-year-old. Lot number was Ez9264. Medical history included asthma, interstitial cystitis, allergy to peanuts. The patient experienced anaphylactic reaction with GADAVIST. Concomitant medications were unknown. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 04:30 in right arm at the age of 44-year-old for Covid-19 immunisation (lot number was Gl3249). The patient was not pregnant. On 03Feb2021 at 07:15, the patient experienced extreme heat in face that lasted 2 minutes. Red face and ears all day but no more extreme heat. On 06Feb2021, Bell's palsy on right hand side of face occurred. The patient was not treated for the events. The patient did not recover from the events. Patient was not covid tested post vaccination; patient did not have covid prior vaccination.
44 2021-03-17 feeling hot Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to am... Read more
Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to ambulate to observation on her own and then signaled staff for help, felt hot, felt dizzy, felt nausea, staff immediately assisted to chair, RN @ side; inquired re food; had lunch; sips of beverage w sugar given able to eat cracker. She stated she felt better, was upright in her chair, no SOB, no complaints of swelling throat, itchy etc. After some initial sips of liquid, still feeling dizzy lowered to floor by staff w wedge cushion and legs and feet elevated above heart per protocol b/p 140/96 pulse 86. Stated she had been anxious re injection, but denied ever having this experience after injection. Additional information for Item 18: Reviewed the POD form questions again with her, denied any issues. She then stated she was feeling much better again, her warm feelings were going away from ice in a glove that we had used from her initial dizzy, warm/hot feeling. Around 3:30 she felt nausea again, so we sat her up and gave her a bucket to use to vomit if needed. She was unable to vomit. She wanted to sit up on floor. We sat with her and she sipped on clear beverage. She began to get cold. We put her legs back up took b/p 140/91 pulse 86. No change. We called nursing DON for District to make her aware and by that time patient experiencing chills. We called her husband to be on his way to drive her home after 30 minutes @ 3:45. She continued to tell us she felt better for a few minutes only to then tell us she was feeling nausea again. Rolled her to left side, helped her to prop us to vomit but she was unable to vomit anything. B/p readings 147/91, 150/90, 140/87,150/88She desired to sit upright again. So on floor with nurse holding and b/p cuff on sat her up to try to vomit, unable to do so. Lowered back to floor with legs upright where she remained local Paramedic on site and he came to assist, a portable recliner that allowed for legs to be elevated above heart was set up. Patient felt that she could transfer with paramedic and staff help and passed out while attempting briefly, chilling when she was alert, then passing out again; 911 was called and arrived by 3:55, patient and husband initially wanted to take patient home after hearing patient state she felt better once paramedics had evaluated her. However in front of husband, patient again passed out, and after she was conscious stated she could not feel her arms. and when he observed this he agreed it was best for her to be evaluated and then was transported to ER. Per phone conversation this morning, at 10:41 husband stating that patient still not able to stand without passing out on her own and they were continuing to evaluate her. No additional medication given on site at Mass vaccine site.
44 2021-03-17 flushing I received my first round of the Covid19 vaccine on Tuesday. They had us wait for 15 minutes to see ... Read more
I received my first round of the Covid19 vaccine on Tuesday. They had us wait for 15 minutes to see if there were issues. Sitting there I had no issues. By the time I got back to work maybe 15 minutes later I felt like I was foggy headed. It was like a was on a high dose of cold medication. I was also very flushed. I was okay sitting but movement brought it on. I was also pretty tired.
44 2021-03-17 pain in extremity, cold sweat Like a spider bite after 7 minutes, could feel the vaccine run into my shoulder, then my neck and en... Read more
Like a spider bite after 7 minutes, could feel the vaccine run into my shoulder, then my neck and enter my nasal cavity. At which time it seemed to dry up what ever nasal mucus I had. Almost immediately I felt dizzy and light headed. Then came the my heart beating faster. My breathing quickened cold sweats began with the palms of my hands. This continued for about 3-4 minutes. When my heart/ blood pressure seemed to go back to normal, I sat for an additional 15 minutes. I had 3 more incidents that day of dizzy and lightheadness throughout the day but not to the extent of the initial, almost passing out, spell. For 12 hours after injection, other than the typical reported symptoms of sore arm, fatigue which I did experience, i felt like I was in a haze, similar to when you have a fever for 11 hours. And oddly, almost immediately the haze and fatigue lifted. No other adverse reactions after that.
44 2021-03-17 pain in extremity Light headed and slight dizziness along with string metallic taste in mouth almost immediately follo... Read more
Light headed and slight dizziness along with string metallic taste in mouth almost immediately following injection. These symptoms dissipated after about 15 minutes and I was able to drive home. An hour later I started to have intense muscle and joint aches all over my body with slight dizziness. My left arm, regardless of continued movement, became increasingly sore. The next morning only slight aches and dizziness remained and I was able to go to work. By the end of the eight hour work day, the joint and muscle aches and fully returned accompanied with intense pain in my left arm, hand, and neck. Today I feel no symptoms at all.
44 2021-03-17 pain in extremity Sore arm at the injection site which was very painful for 2 days. patient also complained of runny ... Read more
Sore arm at the injection site which was very painful for 2 days. patient also complained of runny nose on 3/4 which lasted for about 4 hours.
44 2021-03-17 tingling Right side of face, neck and chest broke out in hives. I had numbing in my lips and tingling on the ... Read more
Right side of face, neck and chest broke out in hives. I had numbing in my lips and tingling on the right side of my body.
44 2021-03-17 tingling sharp ache sensation going up Right side of neck behind ear. Sensation decreased and turned to ting... Read more
sharp ache sensation going up Right side of neck behind ear. Sensation decreased and turned to tingling "all feelings are internal, feels like icy hot on my neck" no pain with palpation, injection site WNL, no redness, welling or warmth, no pain at injection site or arm, no los of ROM.
44 2021-03-17 tremor Waited the required 15 minutes after vaccine and done just fine. Started my drive back home and abou... Read more
Waited the required 15 minutes after vaccine and done just fine. Started my drive back home and about 15 minutes into my drive I began feeling very funny in my head, my heart rate went sky high, started shaking all over my body. Could barely drive called 911. Was advised to pull over and await for ambulance. Ended up at ER with elevated heart rate, chest pain and feeling winded. I could breath ok no swelling in throat but just felt like a elephant was on my chest
44 2021-03-18 flushing Hives/rash developed on chest and side of neck, as well as facial flushing, about 15/20 minutes afte... Read more
Hives/rash developed on chest and side of neck, as well as facial flushing, about 15/20 minutes after the injection. Blood pressure was taken repeatedly and high 150/100.
44 2021-03-18 migraine Migraine headache almost continuously since vaccine. Had not had regular migraine in over 10 year.
44 2021-03-18 pain in extremity Arm pain immediately following vaccination. 2 hours later, became extremely itchy all over body (no ... Read more
Arm pain immediately following vaccination. 2 hours later, became extremely itchy all over body (no rash.) One raised hive popped up on my stomach. I took Benadryl to reduce itchiness so I could sleep. Today I am dealing with a mild headache and bad diarrhea immediately after eating.
44 2021-03-18 pain in extremity Low grade fever (100.1F); Achy joints; headache; sore arm, especially at injection site; sore arm, e... Read more
Low grade fever (100.1F); Achy joints; headache; sore arm, especially at injection site; sore arm, especially at injection site; muscle aches; This is a spontaneous report from a contactable healthcare professional (the patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 12Feb2021 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: vitamin C and ibuprofen (ADVIL), both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 22Jan2021 13:45 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 06:00, the patient experienced low grade fever (100.1F), achy joints, headache, sore arm, especially at injection site, and muscle aches. The clinical course was as follows: Low grade fever (100.1 F), achy joints, headache and sore arm, especially at injection site, at 06:00 on 13Feb2021. Low grade fever lasted for about 10 hours, took ADVIL, which brought temperature to normal level (98.8 F). Slight headache still remained on 14Feb2021, but ADVIL relieved that. Fever and muscle aches dissipated by morning of 14Feb2021. No treatment was received for achy joints, sore arm, especially at injection site, and muscle aches. The clinical outcome of the events fever and muscle aches was recovered on 14Feb2021, and for other events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
44 2021-03-18 pain in extremity Left arm fatigued, sore, still painful after over a week. Pain radiates down arm. Issue is not getti... Read more
Left arm fatigued, sore, still painful after over a week. Pain radiates down arm. Issue is not getting worse just staying the same.
44 2021-03-18 cold extremities, pain in extremity I had a slight headache prior to the vac one that lasted through the next day so I?m not sure if the... Read more
I had a slight headache prior to the vac one that lasted through the next day so I?m not sure if the vaccine contributed to it. Around 530 pm I started feeling fatigue and a slight wave of nausea. The nausea did not last long. By 6:30 pm I was exhausted and began having chills - my feet especially felt cold. I then crashed hard and slept for a few hours. The next morning my arm was slightly sore and by the evening I felt extra tired.
44 2021-03-19 pain in extremity Arm is achy, running a high fever, chills, sweats
44 2021-03-19 pain in extremity Approximately 3 hours after the shot, I got a horrible headache - the same one I had with COVID. I a... Read more
Approximately 3 hours after the shot, I got a horrible headache - the same one I had with COVID. I also felt tired and body aches. The next day I was exhausted, could hardly keep my eyes open and could not get enough water. My arm began to hurt, I had chills/fever, and my shoulders/back of my head hurt a LOT. I also was congested, coughing and sneezing, and my chest felt tight. My knuckles and toes hurt as well. Tylenol, day-quil, aspirin, - none of these worked. I had COVID back in June/July 2020 and the symptoms are all the same ones I had.
44 2021-03-21 breast pain, pain in extremity, weakness Shot at 10:30 AM Thursday, experienced intense soreness in right arm (far worse than the 1st shot in... Read more
Shot at 10:30 AM Thursday, experienced intense soreness in right arm (far worse than the 1st shot in left arm) and by mid-afternoon headache. Overnight woke with fever, chills, headache and sore arm making sleep impossible. Ill all day Friday - fever, chills, fatigue, no appetite, headache, arm soreness. Friday evening awoke with intense pain in right arm pit, breast, upper ribs - extremely swollen lymph nodes (size of avocado). Extremely tender and sore. Pain continued throughout Saturday, Sunday, and now into Monday. Also still fatigued and feeling run down.
44 2021-03-21 feeling cold About 3 hours after the injection I began to feel tired and lethargic. 10 hours after the injection ... Read more
About 3 hours after the injection I began to feel tired and lethargic. 10 hours after the injection I began to feel more cold than normal. 12 hours after the injection I realized I had a fever and it took about 3 hours to break. By the next morning, today, I felt sore all over my body, like I had been non-stop throwing up. I had a raging headache in my right eye. Still feeling very lethargic. 27 hours later I still feel not myself.
44 2021-03-21 feeling of insects crawling on skin Approximately 6 hours after injection I began to feel as if my skin was burning and itching. Had cr... Read more
Approximately 6 hours after injection I began to feel as if my skin was burning and itching. Had crawling sensation throughout body and throat felt a little tight/dry. The burning, itching and crawling feeling continued for a couple weeks. Had to take Allegra and Benadryl and currently am still taking it to ward of symptoms.
44 2021-03-22 feeling hot, tingling Shortly after vaccination patient reported feeling hot and dizzy with tingling in throat and legs. ... Read more
Shortly after vaccination patient reported feeling hot and dizzy with tingling in throat and legs. IV was started and patient was given Solumedrol and Benedryl before being taken to ER by EMS.
44 2021-03-22 numbness, tremor, tingling, pain in extremity, weakness Continued sensitivity & "nausea" in arms and chest similar to first dose, but more continuous. Abou... Read more
Continued sensitivity & "nausea" in arms and chest similar to first dose, but more continuous. About a week or so after, extreme fatigue and body weakness began and never stopped. Weakness/shakiness/tremorlike tingling body/arms/legs. It would come and go mainly in arms at first. Now it is constant all over body and it never goes away- 2 months. The muscle weakness is debilitating. First tingling/weakness/shakiness, followed by numbness in arms and legs, mainly right leg. Also arms started falling fully asleep and numb at night while sleeping. During day constant muscle and body weakness/tingling - is constant and almost unbearing. Feels like bugs are crawling under skin all over body, fatigue, numbness, (pins and needles come and go, very "elective" kind of surges through. Sometimes remains and fades). Newest symptom as of only a few days ago, pain in elbows, upper arms, knees, legs, shins, lower back, shoulders, back. Achy pain and burning pain. Pain is new, came before the Burning pain, which is the latest. I imagine these pains are my muscles dying. Muscle Atrophy per ER 3/21/21 visit.
44 2021-03-22 pain in extremity Significant headache, significant arm pain (hard to even move arm), significant right armpit pain, s... Read more
Significant headache, significant arm pain (hard to even move arm), significant right armpit pain, significant aches/pain all over mainly lower back and hips, exhaustion, neck pain
44 2021-03-22 pain in extremity Sore arm 2 days, fatigue 1 day
44 2021-03-22 tingling, numbness Pfizer-BioNTech COVID-19 Vaccine EUA 1. Left side of face was numb for a few minutes, got better, th... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 1. Left side of face was numb for a few minutes, got better, then got numb again. Numbness went away again. Over the last few days, left side of face has felt weird. Kind of tingly near cheek bone and under eye. 2. Sore shoulder for ~ 36 hrs. 3. Headache for ~ 48 hrs.
44 2021-03-23 flushing, feeling hot Felt flushed/hot about 30-60 minutes after shot. Muscle pain at site of injection and throughout upp... Read more
Felt flushed/hot about 30-60 minutes after shot. Muscle pain at site of injection and throughout upper arm - painful throughout the night. Pain dissipated somewhat 26-28 hours out from shot. Ran low-grade fever about 29 hours out from shot. Nausea, just general malaise throughout the day.
44 2021-03-23 flushing, feeling hot Patient came in to get her second COVID shot. informed me that she had reactions to the first (lymph... Read more
Patient came in to get her second COVID shot. informed me that she had reactions to the first (lymph node swelling, hives, bells palsy symptoms, and nausea). Her doctors and specialists discussed it with her and agreed they wanted her to have the second dose. She had pneumonia twice, had covid and has residual effects from it, and had mono. They were unsure if the symptoms were directly from the immunization or the fact that she had mono/pneumonia when she got it and didn't know. I Gave her the immunization and she said she felt warm after it. I sat with her for 30 minutes and she said she felt flushed and itchy, she was given 10 ml of Benadryl 12.5mg/5ml. She had no visible hives or swelling at the injection site or on her chest or arms. She felt nauseous and took her own phenergan. After sitting for 45 minutes together she said she wanted to go home. She went shopping for a few things and checked in before she left. I told her if there was any swelling at all in her throat/face or if she felt like she couldn't breathe to call 911 or get to the hospital immediately. She said she would and I will call tomorrow to follow up with how she is feeling.
44 2021-03-23 flushing After receiving 2nd dose of pfizer covid vaccine patient waited her 15 minutes and went to car to le... Read more
After receiving 2nd dose of pfizer covid vaccine patient waited her 15 minutes and went to car to leave but noted she was developing hives on her chest and flushing of face. She had no difficulty breathing. She waited in car for 5-10 minutes but it was not subsiding so she re-entered the facility and sought out EMS for evaluation. At that time she was noted to have confluent hives on chest and flushing of cheeks but no angioedema, throat or tongue swelling, sob, wheezing, difficulty breathing, or difficulty speaking. Hives remained localized to chest and flushing to cheeks. Vitals were stable and remained stable. She was observed x 20 minutes with no further progression of symptoms. She was offered benadryl but refused as she has a 1.5 hour drive home and has no one here with her. She was offered decadron but refused. She opted to drive to nearest gas station to get non drowsy antihistamine. She carries her own epi pen due to bee sting reactions and is well versed in how to use it. She was instructed to call 911 if getting worse or if she needs to use epi pen.
44 2021-03-23 pain in extremity She had previous reaction to Paclitaxel and was given vaccine in high risk COVID vaccine allergy cli... Read more
She had previous reaction to Paclitaxel and was given vaccine in high risk COVID vaccine allergy clinic. We pretreated her with cetirizine but did not test her to PEG. She developed significant distress, nausea and cough 2-3 minutes after receiving the vaccine. There was no hypotension, wheezing noted. She was treated promptly with epinephrine 0.3 mg. Within five minutes she started to feel better aside from adverse effects from Epi. Left arm and shoulder pain. No significant shortness of breath. She had a large amount of clothing on so were unable to fully see skin but no visible rash. She was transferred to the emergency department.
44 2021-03-23 pain in extremity I felt fine for the fors 24 hours. Limited arm soreness, no other symptoms. At 11:00Am Sunday I bega... Read more
I felt fine for the fors 24 hours. Limited arm soreness, no other symptoms. At 11:00Am Sunday I began to get achy at my joints. I was out on a 5 mile hike and unable to turn around. When I got home took Tylenol and rested. At 11Pm Sunday night I started feeling itchy and discovered a full body rash. They were raised patches and if i scratched myself the area would swell up like a hive. Took Benadryl and it was mostly gone by morning. At 11:00pm Tuesday night I started feeling itchy again and discovered the rash had returned again. Again took Benadryl and it was mostly gone by morning.
44 2021-03-23 pain in extremity Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left whe... Read more
Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left when she passed out and fell in shower; Ear completely clogged up only on the left side; Headache; Tired; Soreness on my arm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 07Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included underactive thyroid. Concomitant medication included unspecified thyroid medication. The patient was asking if her symptoms were normal following the vaccination. She got the second dose of the COVID vaccine yesterday, 07Mar2021 at around 11:00 (also reported as 10:00 to 10: 15 or 10:30). Throughout the day, she was fine and mentioned that she had soreness on her arm later. At around 22:00, she was driving home and started feeling a slight headache and reported that she didn't take anything. She was tired, so when she got home, the patient fell asleep. She woke up and did feel a slight headache and couldn't sleep on her left arm because it was killing her, but it was fine. At 5:30 this morning (08Mar2021), the headache was still there. She then stood and sat up, took her thyroid pill because she has an underactive thyroid and was on the highest dose of thyroid replacement. The patient stated that the events happened so fast, as soon as she got into the shower. She got out of bed and started walking, grabbed her stuff to shower and started feeling that her headache was building up more than it had all morning so far. She thought maybe it was just because she had just physically gotten up and started walking. She got into the shower, and for about 2-3 minutes into getting into the shower, she remembered she had started putting shampoo into her hands; grabbing the shampoo bottle; but she suddenly got so nauseous and the headache that came on was extreme. She did not have a lot of time to react. She thought she would throw up in the shower, she had no time to get out of the shower to the toilet to throw up; she suddenly felt dizzy, passed out in the shower and fell to her left side on the floor. All she could remember before she passed out was that she had the shampoo bottle in her hands and she said out loud, she heard herself say "What is happening to me". Then she lost all the strength in her arms and legs. She remembered for a split second she tried to hold on, she dropped the shampoo bottle on the floor and grabbed the rail or edge of the shower and tried to hold on because she felt herself when she went down. Her left ear was completely clogged up only on the left side. When she passed out, thankfully she thought by trying to hold on to the rail or edge of the shower that she kind of eased her fall down, so she did not fall hard or hit her head. She did not know if she passed out for seconds or minutes because she has no idea exactly when she went into the shower, maybe around 05:45; but when she woke up she realized she was on the floor, she was not flat on the floor but on her knees, having fallen to the left side with her head off to the side on the shower wall; the glass door to her shower was wide open and all the water was coming out of the shower; it scared her when she woke up. The outcome of the event passed out was recovered on 08Mar2021, not recovered for headache, and unknown for all other events. Information on the lot/batch number has been requested.
44 2021-03-24 discomfort, flushing Headache, Myalgia, felt flushed and body felt heavy. Narrative: Patient VS were checked and WNL. Pa... Read more
Headache, Myalgia, felt flushed and body felt heavy. Narrative: Patient VS were checked and WNL. Patient was furthered monitored in vaccine clinic and given water. No further actions required and no further complaints from patient.
44 2021-03-24 numbness 15:10 Patient verbalized feeling lightheadedness, sweating and left hand numb. Vital signs taken at:... Read more
15:10 Patient verbalized feeling lightheadedness, sweating and left hand numb. Vital signs taken at: 15:15 Bp 150/90 HR 80 Spo2 99 Temp: 97.1 F @ 15:20 Bp 147/93 HR 76 Spo2 99 @ 15:25 Bp 145/91 HR 82 Spo2 99 @ 15:30 BP 149/83 HR 71 Spo2 100 @ 15:35 BP 155/91 HR 72 Spo2 100 15:50 patient stated "feeling better" repeat vitals before releasing, BP 152/91 HR 78 Spo2 100 Patient was advised to follow up with PCP prior to recieving second dose of Covid vaccine. Patient left with daughter. (Initials) LVN
44 2021-03-24 muscle spasms My upper lip began to spasm and became numb. I also had some slight numbness on the tip of my tongue... Read more
My upper lip began to spasm and became numb. I also had some slight numbness on the tip of my tongue.
44 2021-03-24 tremor, numbness, tingling Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous... Read more
Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous/shakes; Immediately felt tingling, got shaky and nauseous; hard time swallowing and couldn't breathe right; hard time swallowing and couldn't breathe right; Waves of heart racing; her left leg and arm, her right leg had pins and needles and loss of feeling; wheezing; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 09:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient experienced immediately felt tingling, got shaky and nauseous. It was coming in waves. she was having a hard time swallowing and couldn't breathe right. She was in the holding. For 15 minutes and she received dismissed annoyed no help from an EMT working in the waiting area for effects. She left. Got a mile down the road and called 911 she was unable to get enough oxygen in. The ambulance arrived and immediately gave her epinephrine, Benadryl, and a breathing treatment along with other medications. She arrived at the hospital and she was doing better and they kept her for observation. She was feeling fine, left with an Epipen and prednisone. The next day (18Mar2021) she felt great until the night time she started wheezing again. She woke up on Friday (19Mar2021). Having shakes and hard time breathing and waves of heart racing. she made a doctor's appointment and received a inhaler. Her symptoms were not getting better and she took Benadryl which helped. By that night her left leg and arm, her right leg had pins and needles and loss of feeling. Treatment included Epinephrine, Benadryl, Prednisone, Albuterol. No COVID tested post vaccination. Events immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right required clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. Outcome of immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right was recovering.
44 2021-03-25 migraine, pain in extremity After the first vaccine I got swelling and a hard lump at the site of injection. I couldn?t even lif... Read more
After the first vaccine I got swelling and a hard lump at the site of injection. I couldn?t even lift my arm for more than 24 hours and then the lump lasted over a week. Then after second dose I also got sore arm and a lump but developed a rash on my arm too. (Same day). Next day I had low grade fever and body aches and chills. 2 days after the vaccine I woke up with a migraine and still didn?t feel well but no more fever. I also had small blister like rash on my inner thigh that developed about 10 days after the first vaccine but thought they were unrelated. Today I saw a dermatologist and she said the rash on my leg was Shingles and was also caused from the vaccine.
44 2021-03-25 muscle spasms Anaphylaxis: Shortness of breath, chest tightness, itching, muscle spasm
44 2021-03-25 muscle twitching right sided facial twitching; severe soreness in the vaccine site; fatigue; body aches; gastrointest... Read more
right sided facial twitching; severe soreness in the vaccine site; fatigue; body aches; gastrointestinal pain; dizziness; heart palpitations; This is a spontaneous report from a contactable Other HCP (the patient). This non-pregnant 44-year-old female patient received her second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318 ), via an unspecified route of administration, in left arm on 20Feb2021 at 11:15 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included Grave's disease (treated with an ablation resulting in hypothyroidism). The patient had known allergies to raw egg whites, red food dye, and penicillin's. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine sodium (TIROSINT). The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot # EN5318, on 30Jan2021, in the left arm COVID-19 immunization. On 20Feb2021, within 4 hours of receiving the vaccine at 4:15 PM, the patient experienced severe soreness in the vaccine site, fatigue, body aches, gastrointestinal pain. Starting at 48 hours after the vaccine she experienced dizziness, heart palpitations, and right sided facial twitching, No treatment was received. The clinical outcome of right sided facial twitching, severe soreness in the vaccine site, fatigue, body aches, gastrointestinal pain, dizziness, heart palpitations was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
44 2021-03-25 tingling, inability to speak I had long term Covid symptoms from early February 2020 to late February 2021 including, intense con... Read more
I had long term Covid symptoms from early February 2020 to late February 2021 including, intense concussion like brain fog for months, coughing for months, problems with my fingers seizing up and twitching uncontrollably, and extreme exhaustion for months. I had finally started to feel Covid free, except for some problems with my left hand, by end of February 2021. I got the first dose and about 45 minutes or so later the exhaustion came back suddenly - like someone removed all my batteries - and I started having trouble talking, thinking, remembering. Reading and writing work, but talking is difficult. My hands feel swollen and lacking dexterity and strength. I had an odd headache in the middle of the night (on day 2) with some sharp pain that kind of seeped around my scalp. I thought at first I had been stung by a bee and it went away as quickly as it came. But then the pain would suddenly appear on another part of my scalp. There was a tingling/seeping/spreading out feeling just before it would disappear. I woke up the next morning with a more normal headache, took IBU and CBD gummies, ate breakfast and it?s gone. I feel like all I can do is lay in bed and stare at the wall. This is exactly as I felt when I had Covid (though without finger seizures and coughing). I find myself coming to tears with a fear that it won?t ever go away or I?ve brought it on again by getting the vaccine.
44 2021-03-25 tingling I had headaches at first but then I had heart palpitations that have lasted for 2 weeks. I've had di... Read more
I had headaches at first but then I had heart palpitations that have lasted for 2 weeks. I've had difficulty breathing for 2 weeks. I have had eye twitching in my left eye for 3 days. I have had tightness in my chest and tingling in my chest.
44 2021-03-25 seizure On 3/24/21, almost a week after my second vaccine shot, I had a seizure while sleeping in bed. I had... Read more
On 3/24/21, almost a week after my second vaccine shot, I had a seizure while sleeping in bed. I hadn?t had a seizure in over 30 years, and then only with a fever (I had febrile seizures as a child). My husband got some of it on video after being unsuccessful waking me.
44 2021-03-26 bell's palsy Bells Palsy
44 2021-03-26 difficulty speaking She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swel... Read more
She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swelling and vocal changes with wheezing within 15 minutes of receiving the vaccine. She was treated with benadryl and albuterol and sent home after improvement. After going home, continued to have some lip/throat swelling. She then presented to local hospital with worsened symptoms, treated with benadryl and steroids, given a script for prednisone, and sent home. She did not fill the prednisone script initially, but had some prednisone (unknown strength) at home and took a pill. The following morning (3/26), she continued to have throat and lip swelling and began to develop some dyspnea. Due to these worsening symptoms, she came to ED. She received a total of 5 doses of IM epinephrine (1734, 1938, 2010, 2320, 0017) along with IV pepcid and IV solumedrol for persistent subjective throat swelling, dyspnea, and difficulty tolerating secretions. She was admitted to the ICU for close monitoring of symptoms and consideration of an epinephrine drip, but did NOT require this. In the morning of 3/27, she noted substantial improvement in symptoms of tongue/lip swelling, improved wheezing, dyspnea, and dysphagia. Still with some mild hoarseness that she attributes to cough, also improving.
44 2021-03-26 feeling hot My arm became very hot later in the night and then my face got really hot and when I woke up my face... Read more
My arm became very hot later in the night and then my face got really hot and when I woke up my face was swollen like I had a mild reaction
44 2021-03-28 weakness, night sweats, muscle spasms The first shot on March 6, 2021, I only felt muscle pain in my left arm unable to move it on the ne... Read more
The first shot on March 6, 2021, I only felt muscle pain in my left arm unable to move it on the next day due to the injection. Nothing else. The second shot on March 27, 2021 I started with fever, chills, night sweats, stomach cramps, headache, sore throat, nausea, tiredness, shortness of breath, muscle pain, weakness, unable to concentrate or do my job.
44 2021-03-28 flushing Within the first hour after receiving the vaccine, I experienced a flushing warm sensation in my ski... Read more
Within the first hour after receiving the vaccine, I experienced a flushing warm sensation in my skin on my face and neck area. About 2-3 hours after receiving the vaccine, I broke out in a skin rash on my face, neck, and upper body. About 2 days later, the rash began to diminish. Now (6 days later) it has continued to recede (although it is still somewhat visible).
44 2021-03-28 numbness Issue - patient had gotten shot, waited in car, then immediately after leaving grounds felt numbne... Read more
Issue - patient had gotten shot, waited in car, then immediately after leaving grounds felt numbness of the tongue, throat and roof of her mouth. EMS took vitals and patient did not wish further treatment and went home. This was her 1st shot.
44 2021-03-28 migraine Dizziness lasting from three days after first dose to four days after second dose (March 21, 2021). ... Read more
Dizziness lasting from three days after first dose to four days after second dose (March 21, 2021). Dizziness stopped a few days before second dose, and then started up again one day after second dose. Migraine or intense heachaches with dizziness every few days for a month. Headaches still occurring every three or four days at present (March 29) about every two days, but getting more spread out. I usually get one headache a month, so this is unusual.
44 2021-03-28 pain in extremity Soreness in L arm started within two hours. At 6 hours post vaccination, lethargy began. That night,... Read more
Soreness in L arm started within two hours. At 6 hours post vaccination, lethargy began. That night, I slept about 12 hours, something I only do when I'm sick. That whole day I had full body aches, was extremely tired, and may have had a low-grade fever in the evening (I do not have a thermometer to verify).
44 2021-03-29 numbness Patient reported muscle weakness and dizziness starting at 1415. Vital signs at this time were as fo... Read more
Patient reported muscle weakness and dizziness starting at 1415. Vital signs at this time were as follows: 117/75 mm Hg, Pulse 90 bpm, oxygen saturation 98%, and respiratory rate 18 bpm. RN noted muscle weakness in extremities, and sweating. Patient reported dizziness and feeling like she would pass out. Vital signs at 1420 were as follows: 114/75 mm Hg, pulse 109 bpm, oxygen saturation 99%, and respiratory rate 20 bpm. Patient reported not eating food, or drinking water recently. Patient was provided water and candy, and had persistent numbness and weakness in extremities. Paramedics were called to assess patient. Paramedics assessed and found patient not meeting medical necessity (vital signs WNL). Patient signed medical wavier paramedics provided. Vital signs were as follows: 117/73 mm Hg, Pulse 91 bpm, and oxygen saturation 99%. Patient reported "feeling better, and wanting to go home." Paramedics escorted patient to her car, along with her husband. Patient was provided information to call medical professional if symptoms worsen.
44 2021-03-29 seizure, pain in extremity I started having normal side effects such as sore arm, extreme tiredness and headache within 2 hour... Read more
I started having normal side effects such as sore arm, extreme tiredness and headache within 2 hours. By later that night I was in a dazelike state, had a lot of forgetfulness and lived life but as if I was sleepwalking and started having seizures over the next few days. A week later I'm still having seizures, have no recollection of anything starting from the night of the day I got vaccinated
44 2021-03-30 weakness While waiting in the observation area and approximately 10 minutes after receiving the injection, I ... Read more
While waiting in the observation area and approximately 10 minutes after receiving the injection, I felt a strange wave come over me and I became very lightheaded and felt weird all through my body. I can't really explain the sensation. I passed out and when I came to, I was very weak. The staff at the facility gave me oxygen and took my blood pressure. They called the paramedics. The parademics did an EKG which was normal and they took me to the ER for some other routine testing, which was all normal and then I was released. Since then, I have felt a bit nauseous and tired.
44 2021-03-30 tingling, numbness patient described arm was tingling all the way down to the hands, felt weird. like numb feeling
44 2021-03-31 mild one side paralysis, numbness Patient complained of left sided partial numbness/paralysis that started about 1 hour after she had ... Read more
Patient complained of left sided partial numbness/paralysis that started about 1 hour after she had the vaccine and that lasted for about 1 hour and self resolved to normalcy.
44 2021-03-31 numbness, tingling, pain in extremity Arm pain at first but then Got up to go to bathroom, suddenly felt nausea and then numbness on left ... Read more
Arm pain at first but then Got up to go to bathroom, suddenly felt nausea and then numbness on left side of body, vision became blurry and I passed out. Hit head when fell. Couldn?t regain consciousness for 10-20 minutes. Couldn?t move, get off floor. Husband had to come carry me back to bed. Felt tingling in arms, legs on both sides. After an hour, had water, iced arm (extreme arm pain), and felt better but stayed in bed.
44 2021-04-01 numbness Purplish red spots on bottom of feet, lasted >day; headaches, fatigue, confusion, numbness in hands/... Read more
Purplish red spots on bottom of feet, lasted >day; headaches, fatigue, confusion, numbness in hands/ arms and feet. All but spots continue today. Nausea for 3 days, 3/29-3/31. Diminished sense of smell and taste, still.
44 2021-04-01 pain in extremity Severe headache Rash on face Arm sore
44 2021-04-01 tremor Chills, shaky, fatigue, nausea, headache
44 2021-04-02 feeling hot Shortly after receiving shot patient started to feel sweaty and hot, patient was observed that her h... Read more
Shortly after receiving shot patient started to feel sweaty and hot, patient was observed that her head was falling back and she was passing out and her friend caught her as she was passing out she was lowered to the floor and placed on a back board and placed on a litter and taken to medical observation, vital signs obtained and her blood pressure was 108/75 @ 11:11 Heart rate 75, follow up blood pressure was 101/66 HR 77 pulse ox was 98% on room air, patient was observed and she was discharged to home she was escorted out via wheelchair.
44 2021-04-02 numbness, weakness, tingling, pain in extremity Started with normal sore arm and headaches transitioned to diarrhea and fever. Tinnitus set in on Th... Read more
Started with normal sore arm and headaches transitioned to diarrhea and fever. Tinnitus set in on Thursday morning and has continued since then. Friday night I experienced a loud pop on the left side of my head - pressure released on the left year slightly followed by numbness and tingling in face along with blurred vision, dizziness and weakness in left leg. Blurred Vision lasted maybe 1-2 minutes, numbness and weakness/dizziness resolved on ride to ER so maybe 10 minutes as we live near the hospital. ER evaluated me for potential stroke. Cat scan and labs done. Nothing odd was noted. Doc decided it was parethesia of left leg and nonintractable episodic headache event. Blood pressure was elevated which is unusual for me along with a high White blood cell count- Doc said this is normal with just having received a vaccine recently. No concerns with platelets or enzymes and electrolytes. Doc does think it could be vaccine related as that is the only thing new this week. Due to earlier in the week side effects, my PCM did COVID test me just incase since the side effects were hanging around longer than the normal window of time and nasal swab PCR came back negative.
44 2021-04-02 pain in extremity On 4/2/21, arm pain, body aches, bad headache, chills, fatigue, redness at injection site. At about ... Read more
On 4/2/21, arm pain, body aches, bad headache, chills, fatigue, redness at injection site. At about 7:30 pm, I started feeling bruising under my right eye. At about 9:30 pm, I had a small bump under my left eye. On 4/3/21, I woke up with facial swelling. I was swollen underneath my eyes, cheeks were swollen, and lip was swollen. Headache, slight back ache, redness at injection site and sore injection area continue. Took 2 Benadryl at 9:00 am to reduce swelling.
44 2021-04-02 tremor Chills and uncontrollable shaking, fever, full-body aches.
44 2021-04-03 pain in extremity I had fever up to 99.8, leg pain, arm soreness, and a sharp pain in left groin area throughout the n... Read more
I had fever up to 99.8, leg pain, arm soreness, and a sharp pain in left groin area throughout the night April 1st and throughout the day April 2nd. I also had a headache on April 2nd. Tylenol was taken twice on April 2nd. The morning of April 3rd, all symptoms were gone.
44 2021-04-03 tingling, hot flush tingling in arms, legs and torso. Hot flashes in face weak legs and sense of fogginess. Fast and irr... Read more
tingling in arms, legs and torso. Hot flashes in face weak legs and sense of fogginess. Fast and irregular heartbeat.
44 2021-04-04 feeling hot Temporary hearing loss and ear discomfort. Felt like ear pressure when changing altitude quickly, b... Read more
Temporary hearing loss and ear discomfort. Felt like ear pressure when changing altitude quickly, but added with warm burning sensation. Mostly return to normal 6 hours later. Also experienced warmth and uncomfortable tight feeling in right side of neck. Neck discomfort mostly resolved 6 hours later.
44 2021-04-04 pain in extremity Pain scale (1-10, with 1 not bad, & 10 terrible). Shot 2:30pm, 4/3/21. Sore arm within one hour (2),... Read more
Pain scale (1-10, with 1 not bad, & 10 terrible). Shot 2:30pm, 4/3/21. Sore arm within one hour (2), gradually increasing in pain intensity (5). By the evening of the first night headache (5), full body joint pain- felt like bone joints were on fire (8), nausea (4), body aches only from the waist up, and worst on the left side (6), injection site pain (6), hives? on left side of chest- raised itchy bumps, not painful (1). Hives were gone by the morning 4/4/21, all other side effects lasted throughout day 2 at the same or slightly higher pain intensity levels. Additionally around 5pm of day 2 there was an uncomfortable pressure on my chest, felt like someone had their foot on my rib cage pressing down (4). Regular breathing was fine, but I could not take a deep breath, this lasted until about 5am on 4/5/21. Today 4/5/21 there is a slight pressure remaining on my chest for deep breaths but but all other side effects, including injection site pain are gone. (I am usually fairly tolerant of pain, the joints on fire pain is the real reason I am filling this out. The other stuff was tolerable, that pain was terrible,)
44 2021-04-04 tingling First vaccine. Aches, pins and needles in both hands and feet, vomiting, headaches, blurred vision, ... Read more
First vaccine. Aches, pins and needles in both hands and feet, vomiting, headaches, blurred vision, lightheaded, feeling spaced out, exhaustion
44 2021-04-04 tingling Patient felt slight tingling in fingers. Called her back at 3:30pm and she said it seemed better bu... Read more
Patient felt slight tingling in fingers. Called her back at 3:30pm and she said it seemed better but her hand and fingers still felt a little "weird". Vaccine definitely went into deltoid - took picture of site with pts phone and mine.
44 2021-04-04 tremor Visible tremors in extremities, difficulty walking, blurred vision, headaches
44 2021-04-05 feeling cold, pain in extremity 14hrs after the injection, I woke up and didn't know why. Within a minute or so, I started sweating ... Read more
14hrs after the injection, I woke up and didn't know why. Within a minute or so, I started sweating profusely. I started getting massive pain and achiness in my lower abdomen and down through the tops of my legs , down to the top of my knees. I have a very high pain tolerance and it was excruciating. No position lessened the pain. I thought I had to go to the bathroom twice and felt like I would have explosive diarrhea, but nothing happened either time. I just sat there in pain and sweating. I managed to get a drink of water when I started having this low level feeling that I would throw up and decided not to drink too much. I never threw up either. I laid in bed and went from sweating to freezing and back again. I was seriously considering calling 911, but after about 1.5 hours, the pain went from constant to waves and then I got extremely tired and just fell asleep. The next day I was tired and the fatigue lasted probably 3 days, but I had none of the other symptoms again. My arm hurt from the injection (though I really didn't feel the injection itself) for probably 3-4 days, but I ended up with a bruise for more than a week. I never had any Covid symptoms prior to that and I only had neck and shoulder achiness and some fatigue for about 2 days after the 2nd shot - along with the arm soreness, but no bruise.
44 2021-04-05 pain in extremity PT STARTED XOLAIR OVER A YEAR AGO & STARTED WORKING WELL FOR HER W/IN 2 DOSES & WAS CONTROLLING HIVE... Read more
PT STARTED XOLAIR OVER A YEAR AGO & STARTED WORKING WELL FOR HER W/IN 2 DOSES & WAS CONTROLLING HIVES UNTIL ABOUT NOV/DEC 2020. AT THAT TIME SHE STARTED NOTICING VERY MINIMAL HIVES COMING BACK. PT RECEIVED 1ST PFIZER COVID VACCINE ON 3/11. NO CHANGES TO HIVES, STILL MINIMIAL. RECEIVED 2ND DOSE OF VACCINE ON 4/1. THAT DAY/EVENING SHE HAD ARM PAIN & FATIGUE (EXPECTED OF VACCINE). SHE WOKE UP OVERNIGHT W/ SEVERE ITCHING. FRIDAY AM HIVEALL ALL OVER BODY & SEVERE ITCHING. SAT/SUN THE HIVES STARTED RAISING & STILL ITCHING. MONDAY THE SX WERE SO SEVERE SHE WAS NAUSEOUS. MD STARTED HER ON TOPICAL CORTISONE & 5 DIFFERENT ANTIHISTAMINES. CORTISONE HELPS FOR ABOUT 15 MINUTES & ANTI-HISTAMINES DON'T SEE TO RESOLVE ITCHING. PATIENT IS TO FOLLOW-UP WITH MD FOR TREATMENT OF HIVES & POTENTIAL OF COVID VACCINE CAUSING SUCH AN IMMUNE RESPONSE THAT IT OVERWHELMED THE XOLAIR'S EFFECTS AND CAUSED THE HIVES TO OUTBREAK SEVERELY.
44 2021-04-05 pain in extremity No adverse events after first vaccine shot, save for a sore arm. After 2nd vaccine shot, 14-hours af... Read more
No adverse events after first vaccine shot, save for a sore arm. After 2nd vaccine shot, 14-hours after injection felt achy, sore, had chills, and horrible headache - which lasted two days. Then 7 days after the 2nd dose I experienced severe/acute vertigo. I?ve never had it in my life. Got so dizzy I eventually had trouble waking and keeping anything down. The vomiting sent me to the ER. Since being discharged, I?m spinning less and not vomiting or nauseous, but still dizzy. Epley and Foster maneuvers don?t seem to help either. I?m now on day 3 of symptoms since the severe vertigo happened.
44 2021-04-05 tingling Increased heart rate, tingling in hands and face, respiratory difficulty when having a mask on.
44 2021-04-05 tingling Experienced an episode of dizziness/vertigo for about an hour. I was driving when it happened and it... Read more
Experienced an episode of dizziness/vertigo for about an hour. I was driving when it happened and it was pretty severe. I felt like my head was swimming and I felt like my face was tingling and that I was going to faint or pass out.. I made it home safely but barely. a few hours later it is not as severe but I am still very dizzy.
44 2021-04-05 tremor, pain in extremity Nausea, Dizziness, stomach cramps, feelings of stabs in body mainly legs, minor chest pains, heada... Read more
Nausea, Dizziness, stomach cramps, feelings of stabs in body mainly legs, minor chest pains, headache, fever, joint pain, body shakes
44 2021-04-06 pain in extremity Fatigue; sore lower left leg; sore arm; This is a spontaneous report received from a contactable con... Read more
Fatigue; sore lower left leg; sore arm; This is a spontaneous report received from a contactable consumer. A 44-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:15 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included calcium carbonate, colecalciferol (VITAMIN D 2000); linaclotide (LINZESS). The patient experienced fatigue and sore lower left leg and sore arm (pain in extremity) on 24Mar2021 at 07:00. Tylenol was taken as a result of fatigue, sore lower left leg, sore arm. The action taken in response to the events for bnt162b2 was not applicable. Outcome of the event was recovering. Information on the lot/batch number has been requested.
44 2021-04-06 pain in extremity I had my second shot yesterday afternoon and after 2am the following morning, I had a pretty severe ... Read more
I had my second shot yesterday afternoon and after 2am the following morning, I had a pretty severe reaction. Chills, sweat, body aches, vomiting, but what was most concerning was I could feel intense pain in all my joints and lymph nodes. Wondering if the severity was due to my auto-immune disorder. I feel a bit better this morning but I have a wandering internal pain that seems to flare for a few seconds in different body parts: ear, foot, hip.
44 2021-04-06 pain in extremity Joint pain in fingers, wrist, elbows, toes, ankles, knees. Extreme fatigue and prolonged sleeping; s... Read more
Joint pain in fingers, wrist, elbows, toes, ankles, knees. Extreme fatigue and prolonged sleeping; still after 10 days after vaccination.
44 2021-04-06 tremor Heart racing, shaking, light headed, and nauseated it started right away pretty much and lasted abou... Read more
Heart racing, shaking, light headed, and nauseated it started right away pretty much and lasted about 30min.
44 2021-04-07 burning sensation My menstrual cycle runs like a clock. It was not due to happen until April 8th but I got it a week ... Read more
My menstrual cycle runs like a clock. It was not due to happen until April 8th but I got it a week early. I am well aware of how each day goes in my cycle and the flow has been significantly off this cycle. The only variable was my vaccination shot. The injection site was sore, I got headaches and the site itched for days approx 48hrs after the shot. The cycle was almost like spotting for the first 2 days when normally the first 2-3 days are heavy. I am going on a week of the cycle and have only had 1 normal flow day yesterday when usually after 5 days the cycle is ending. Also had this odd burning spot on my chest and back but it only would last a few seconds.
44 2021-04-07 numbness, tingling Within 30-45 mins patient reported feeling numbness and tingling of face, injection site swelling, t... Read more
Within 30-45 mins patient reported feeling numbness and tingling of face, injection site swelling, tenderness and pain, woke up to an agonizing headache that made her feel nauseated and laid in bed all day with the ongoing headache/pressure.
44 2021-04-07 pain in extremity, muscle spasms Pfizer-BioNTech COVID-19 Vaccine EUA Muscle spasms in right arm, shoulder and neck. Limited use of ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Muscle spasms in right arm, shoulder and neck. Limited use of right arm with severe pain.
44 2021-04-07 pain in extremity strong nausea Headache Pain in the arm Fever Muscle pain Loss of appetite Cough Lack of air
44 2021-04-07 tingling PCV heartrate reaction and increase blood pressure Sweating Felt like throat was heavy and might clo... Read more
PCV heartrate reaction and increase blood pressure Sweating Felt like throat was heavy and might close Tingling in arm Arm felt very heavy and warm Nausea
44 2021-04-07 tremor dizziness, shaking. Evaluated by EMS-Cleared
44 2021-04-08 bell's palsy I developed a case of Bell's Palsy as diagnosed by my healthcare provider.
44 2021-04-08 depressed level of consciousness, pain in extremity, tingling Sore arm and hot that evening. The next day - body aches, prickly skin, joint pain, swollen lymph no... Read more
Sore arm and hot that evening. The next day - body aches, prickly skin, joint pain, swollen lymph nodes (sore in armpits and behind ears), extreme tiredness, less alert, more irritable.
44 2021-04-08 discomfort, pain in extremity 1. Within first 15 minutes - burning at injection site; resting heart rate rapid/ increased and rec... Read more
1. Within first 15 minutes - burning at injection site; resting heart rate rapid/ increased and recorded by staff to 130's; trembling 2. 9-10 days after injection; swollen lymph node and discomfort in armpit of same arm where injection occurred
44 2021-04-08 pain in extremity, weakness Fever for a couple days, weakness, arm soreness for 1 day, nausea, diarrhea. Thursday and Friday. Mi... Read more
Fever for a couple days, weakness, arm soreness for 1 day, nausea, diarrhea. Thursday and Friday. Missed work both days. Treatment followed CDC recommendations for common side effects.
44 2021-04-08 pain in extremity Pain in arm for 2 days after injection Hives all over body 6 days after injection
44 2021-04-08 tremor Within 10 minutes skin began to burn on chest, spreading to face. Over the next 5 minutes burning an... Read more
Within 10 minutes skin began to burn on chest, spreading to face. Over the next 5 minutes burning and then itchy spread to arms, back, abdomen and later to legs. Around the 20 minute mark the was a sudden chill then uncontrollably shaking . Itching and burning was intolerable covering whole body head to toe. No visible raised hives. Chest became heavy and tight accompanied by a metallic taste, pain in jaw and hips and sever headache around 45-50 min . Solumedrol, Benadryl and famotidine given in ED. Discharge home. 04/09/21- burning itching skin continues, extreme fatigue, tremor, metallic taste in back of mouth.
44 2021-04-09 feeling cold Client c/o chest pain in the right side upon inspiration; denied past medical hx of MI or angina. Ha... Read more
Client c/o chest pain in the right side upon inspiration; denied past medical hx of MI or angina. Has aspirin allergy. V/S taken every 5 mins. At 12:50pm c/o feeling cold and "head hurts, feel dizzy." Water offered and accepted. At 1:00pm c/o throat tightness. Liquid Benadryl 25mgx2 offered and accepted by client. RN observer offered to call EMS at 12:34 but client's husband stated "let's wait a little." EMS offered again @ 12:54pm and was accepted. EMS fire arrived at 1:17pm and took over.followed up with client on 4/10/21. Client reported labs were done, x-ray and blood draw. All normal acc. to client. Was advised by hospital it was likely d/t aspirin allergy. Client recovered and was d/c same day as incident (4/7/21).
44 2021-04-09 numbness, nerve pain Site: Pain at Injection Site-Medium, Systemic: neuralgia of the left extremity-Medium, Systemic: Num... Read more
Site: Pain at Injection Site-Medium, Systemic: neuralgia of the left extremity-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
44 2021-04-09 migraine extreme fatigue day after; fever of 101.2 day after; coughing 20 minutes after injection; sore/dry t... Read more
extreme fatigue day after; fever of 101.2 day after; coughing 20 minutes after injection; sore/dry throat same day; migraine; Arm of inj. very sore and stiff; This is a spontaneous report received from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, lot number: EN6205), via an unspecified route of administration, administered in left arm on 25Feb2021 17:30 at a single dose for covid-19 immunisation. Medical history included Vascular Ehlers Danlos, Factor V Leiden deficiency and known allergies (Bee stings, coconut, cherries, red food dye). Concomitant medications taken in 2 weeks included requip, aimovig (injection), dexilant, quinine and xarelto. The patient previously took clindamycin and morphine and had known allergies. No other vaccine administered in four weeks. On 25Feb2021 17:45, the patient experienced arm of inj. very sore and stiff, migraine that started 35 minutes after injection and lasted beyond 48hrs, sore/dry throat on same day and coughing 20 minutes after injection. Day after the patient had extreme fatigue and fever of 101.2 on 26Feb2021. The patient underwent lab tests and procedures which included body temperature: 101.2 on 26Feb2021. The outcome of the events was recovering.
44 2021-04-09 pain in extremity, numbness, night sweats, tingling About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went comple... Read more
About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went completely numb and tingling. Scalp tingling and numb. Felt like circulation was cut off. Severe Shortness of breath. Extreme feeling of adrenaline. The next day on March 14th, had extreme vaginal bleeding on day 14 of cycle. Bled for another 7 days which led to extreme anemia. The shortness of breath is every day since the first dose. Heart palpitations (heart rate went up to 190!). After the second dose on 4/03, all symptoms got worst. Left leg went completely numb the same day which I went to the emergency room for. The neurological tingling and numbness was spreading to my whole body. Arms, legs, face, ears, scalp, inside my head. I was worried for a heart attack since all of my symptoms of left arm and shoulder pain and numbness etc. I was released from the emergency room 12 hours later. I continued to have severe symptoms. The shortness of breath was so bad that I didn't sleep for 2 nights straight because my oxygen would drop. I also had severe insomnia and no appetite and lost 5 pounds in 1 week. Major adrenaline feeling. I went back to the emergency room 2 more times this week to check out my heart and lungs. All of my doctors recommended ER since they couldn't help me. My neurologist said he is getting lots of these symptoms from people post vaccine. My shortness of breath and elevated heart rate and numbness and tingling are still here and I can barely go up and down stairs without being out of breath and having a 130-140 heart rate and super low blood pressure and night sweats. It is awful.
44 2021-04-09 pain in extremity, tremor Ringing in ears, swollen glands in neck, joint pain, throbbing pain at injection site, swelling at i... Read more
Ringing in ears, swollen glands in neck, joint pain, throbbing pain at injection site, swelling at injection site, stomachache, fever, chills causing uncontrollable shaking, exhaustion, shooting pains from elbow to hand of non-injection arm, runny nose
44 2021-04-09 speech disorder Complete flare of Postural orthostatic tachycardia syndrome; Complete flare of Postural orthostatic ... Read more
Complete flare of Postural orthostatic tachycardia syndrome; Complete flare of Postural orthostatic tachycardia syndrome; Can't stand up, walk, talk without struggling to breath; Can't stand up, walk, talk without struggling to breath; Can't stand up, walk, talk without struggling to breath; This is a spontaneous report from a contactable nurse (patient herself). A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733, Expiration date: Unknown), via an unspecified route of administration in left arm on 25Mar2021 at 14:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included just POTS (postural orthostatic tachycardia syndrome) from 2 1/2 years prior. Concomitant medication included nadolol received in two weeks. The patient previously took cefepime and experienced known allergies: Cefepime. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID priori vaccination. The patient did not undergo COVID test post vaccination. The patient experienced complete flare of postural orthostatic tachycardia syndrome (last flare was 2 1/2 years prior), can't stand up, walk, talk without struggling to breath on 25Mar2021 at 16:30. The events were considered as serious (disability or permanent damage) by nurse. No treatment medications were received for the adverse events. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the reportedly close drug-event temporal association, a possible contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the development of the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-04-10 weakness Lightheaded, weakness briefly (20 min) subsided
44 2021-04-10 feeling hot Felt hot, heart racing. BP 139/98, HR108, RR16. 20 minutes later, patient recovered with BP 131/81, ... Read more
Felt hot, heart racing. BP 139/98, HR108, RR16. 20 minutes later, patient recovered with BP 131/81, HR74, RR16. Given water
44 2021-04-10 feeling of body temperature change I awoke at 1am with a 101 fever and my skin hurt. I felt hot and cold but was not sweating. By 3 a... Read more
I awoke at 1am with a 101 fever and my skin hurt. I felt hot and cold but was not sweating. By 3 am my fever had risen to 102.3. I waited an hour hoping it would come down on its own but it stayed at 102.3 and I now had a headache. At around 4 am, I took 2 500 mg Tylenol. Approximately 20 minutes later, I began to sweat and fell asleep. I awoke about 30 minutes later and my temperature had fallen to 101.5 and I was sweating. I fell back asleep and awoke at 9:45 am with a splitting headache but a normal temperature.
44 2021-04-10 numbness, tingling - Faster heart rate (within 15 minutes of the injection); no treatment or observation sought (didn't... Read more
- Faster heart rate (within 15 minutes of the injection); no treatment or observation sought (didn't think it was related until later reading it online) - Slight tingling in head and slight numbness is tongue and nose (approximately an hour after the injection); no treatment sought - read about similar instances online and since it was slight, I waited it out and they went away completely a few hours later. The above events occurred within the first two after the injection
44 2021-04-10 tingling BP raised 04/06 SYS:150-160 DIA: 100. Continued with high BP through 04/07 early AN at which point B... Read more
BP raised 04/06 SYS:150-160 DIA: 100. Continued with high BP through 04/07 early AN at which point BP began to lower throughout the day. Experienced Tachycardia -> 150 bmp lying down accompanied by chill on 04/07 early am hours. Also experienced tingling in feet and legs that began 04/06
44 2021-04-11 facial paralysis facial palsy
44 2021-04-11 numbness, hot flush Day after: dizziness, chills, hot flashes, fever, fatigue 2 days post: burning and numbness of right... Read more
Day after: dizziness, chills, hot flashes, fever, fatigue 2 days post: burning and numbness of right ear, right cheek and right side of nose Day 3 post: vertigo and nausea
44 2021-04-12 feeling hot A knot arose overnight at the vaccination site on my upper left arm. The knot is very red. The sur... Read more
A knot arose overnight at the vaccination site on my upper left arm. The knot is very red. The surrounding area is swollen, hot to the touch and very painful. I woke up from the pain several times after midnight when I rolled onto my left side. I do not plan to seek medical attention.
44 2021-04-12 flushing developed skin rash, flushing and mild throat tightness. She has a history of similar events with v... Read more
developed skin rash, flushing and mild throat tightness. She has a history of similar events with various medications and flu vaccine
44 2021-04-12 numbness Numbness bilateral legs same day at night. Blurred and the overlapping visión few days while progre... Read more
Numbness bilateral legs same day at night. Blurred and the overlapping visión few days while progressing over the next 3 weeks, heat intolerance, left side numbness of body. Foggy/ light headedness, dizziness, vertigo and disbalance all progresss over the month the slowly started disappearing over a month after 3 dieses of high steroids and anti- inflammatory.
44 2021-04-12 muscle spasms Fever to 103.9; severe muscle cramping; joint swelling and pain. Joint swelling and pain has continu... Read more
Fever to 103.9; severe muscle cramping; joint swelling and pain. Joint swelling and pain has continued to this day; joint swelling and pain. Joint swelling and pain has continued to this day; This is a spontaneous report from a contactable other health care professional. A 44-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EK9231; Age at vaccination 44 Year), dose 2 via administered in Arm Left on 06Jan2021 17:00 as single dose for covid-19 immunisation. Medical history included Allergies to peanuts, tree nuts. Concomitant medications included famotidine. The patient previously took zithromax and experienced Allergies, bnt162b2 (Lot number: EK5730; 17Dec2020 17:00, Left arm, dose number=1). the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; other medications the patient received within 2 weeks of vaccination: Famotidine; Prior to vaccination, the patient not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. On 06Jan2021 22:30, Fever to 103.9, severe muscle cramping, joint swelling and pain. Joint swelling and pain has continued to this day. ae resulted in Disability or permanent damage; Recovered with lasting effects. The patient not received treatment AE. The outcome of the events was resolved with sequel. ~; Sender's Comments: A possible contributory effect of suspect BNT162B2 on the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
44 2021-04-12 muscle twitching I was left with a tic/ twitch in the corner of my left side of my mouth 2 days after my side effect... Read more
I was left with a tic/ twitch in the corner of my left side of my mouth 2 days after my side effects sore off( dull headache, chills, total body ache) It comes and goes during the day. Never had this before. It is still ongoing.
44 2021-04-12 pain in extremity, muscle spasms, impaired body coordination Starting few days after shot, she started having upper then lower back pain, left > right arm pain, ... Read more
Starting few days after shot, she started having upper then lower back pain, left > right arm pain, left > right leg pain, severe muscle spasms in left leg, numbness in left leg, weakness in both legs, blurry vision and balance problems. This progressively worsened over 2 weeks then started to improve, overall 75% better by 1 month out from the shot. At that time she presented for elevated blood pressure which was also new onset. Exam findings revealed mild ataxia on heel-to-toe walking, asymmetric lower extremity reflexes, and generalized muscle weakness of both upper and lower extremities. Otherwise neuro exam normal.
44 2021-04-12 pain in extremity, tingling Arm and face tingling. After we got home from appointment. I went to take a 30 min nap and my arm ti... Read more
Arm and face tingling. After we got home from appointment. I went to take a 30 min nap and my arm tingled in the upper half near the injection site (in the same way it would feel waking up from being asleep). Around 6:15pm that evening, I was taking a walk and my face began to tingle in the same way (though the "pins" felt smaller then on my arm. Tingling was all around mouth, up into sinus areas on my face. This concerned me and lasted until around 10pm that night. Arm was very sore for 4-5 days.
44 2021-04-12 tingling, weakness At the time of the injections (morning of 4/3), before I even left the person giving the injection, ... Read more
At the time of the injections (morning of 4/3), before I even left the person giving the injection, I could feel the vaccine moving down my left arm. While sitting for 15 minutes for observation I did not have a reaction. However, on my 90 min drive home, the left side of my face and neck felt tingly like the very end of when Novocain from a dentist's office is wearing off. That lasted for a few hours. Then, I was fine until the evening of 4/6 when I started to feel very tired. By 4/7 I felt like I had the flu with absolutely no energy and my throat was so sore I could barely swallow. On 4/8, I was having heart issues including racing and irregularity that lasted that morning. From 4/9-through today (4/13), I have very low energy, feel achy like the flu, and have lots of post nasal drip and stuffiness which is causing a cough.
44 2021-04-12 seizure, concussion Was not instructed to wait after shot so I went to my car. Drove for a couple of hours. Got out of c... Read more
Was not instructed to wait after shot so I went to my car. Drove for a couple of hours. Got out of car, walked forward and passed out with a seizure then throwing up when I came to. Received concussion. Taken to ER and admitted for 5 days. Still experiencing vertigo and nausea
44 2021-04-13 weakness Radiating pain from injection site for at least a week now; significant loss of strength in left arm... Read more
Radiating pain from injection site for at least a week now; significant loss of strength in left arm and overall weakness.
44 2021-04-13 weakness woke up with fever of 102, and had horrible flu-like aches & chills. Due to being under chemotherapy... Read more
woke up with fever of 102, and had horrible flu-like aches & chills. Due to being under chemotherapy at the time, was recommended to go to ER because of the fever. There, I was treated with IV fluids. Labs showed incidental finding of urinary tract infection, so also received IV antibiotics and an NSAID. Later in day after back home, fever was more mild, around 100. I continued to feel like I had the flu for 2 days total. No energy, very achy, and no appetite.
44 2021-04-13 discomfort, pain in extremity Knot/cyst on/around collarbone. Some discomfort and achiness at collarbone, and some in left arm. Ha... Read more
Knot/cyst on/around collarbone. Some discomfort and achiness at collarbone, and some in left arm. Has not yet visited doctor for issue.
44 2021-04-13 numbness After the 2nd shot, about 17 hours after, my body went numb and I had a hard time breathing. I coul... Read more
After the 2nd shot, about 17 hours after, my body went numb and I had a hard time breathing. I could barely breath for about 10 minutes, along with a shooting headache and body numbness. I was going in and out of awareness. Finally, I threw up and was then able to breathe a little better and had feeling in my body again. For the next few days, I had the more typical symptoms of exhaustion and achy. However, a couple days later, I also had stomach pain, bloated feeling, unable to eat much - not sure if that was related to the vaccine or not.
44 2021-04-13 pain in extremity Sore arm in the evening for a few hours on the day I received my vaccine. That was not concerning bu... Read more
Sore arm in the evening for a few hours on the day I received my vaccine. That was not concerning but what was concerning is that my menstrual cycle started 2 weeks early (3 days after the shot). I may be in my forties but I am still very regular (have been for years and throughout this pandemic) so this is a big change for me. I am curious how my future menstrual cycles will be affected or if this is a one time deal (my hope).
44 2021-04-13 tingling, numbness Within five minutes of taking first dose of vaccine I experienced adverse neurological symptoms, inc... Read more
Within five minutes of taking first dose of vaccine I experienced adverse neurological symptoms, including numbness/ tingling (paresthesia) on left side of my body from head to feet, including inside my throat, chest, jaw, and left side of face. Symptom duration lasted approximately 3 hours before gradually diminishing to mild paresthesia in injection arm. Symptoms were significant but not debilitating peaking in severity approximately one hour post dose but continuing. I felt some level of headache and mild imbalance/ vertigo.
44 2021-04-14 discomfort Received the 2nd shot in my left arm a 8am Saturday morning. By early afternoon was experiencing som... Read more
Received the 2nd shot in my left arm a 8am Saturday morning. By early afternoon was experiencing some pain in my right armpit. By that evening I could feel an a lump/mass growing in my armpit. It proceeded to get larger, to a golf ball size, and more painful through Monday. The pain made it difficult to lift or move my right arm. Any contraction of my bicep muscles would trigger pain. Proceeded to make a doctor's appointment for Tuesday, April 13th.
44 2021-04-14 numbness Immediate dizziness upon injection; Upon moving to observation (1-2 minutes), I again had chest/thro... Read more
Immediate dizziness upon injection; Upon moving to observation (1-2 minutes), I again had chest/throat tightness and shortness of breath. Within 5-10 minutes, I began to experience facial numbness; All of these adverse reactions continued for a few hours post-vaccine
44 2021-04-14 numbness Immediate headache upon injection; Upon moving to observation (1-2 minutes), I had chest/throat tigh... Read more
Immediate headache upon injection; Upon moving to observation (1-2 minutes), I had chest/throat tightness and shortness of breath. Within 15 minutes, I began to experience facial numbness; All of these adverse reactions continued for a few hours post-vaccine
44 2021-04-14 tingling AFTER RECIEVING THE COVID 19 PFIZER VACCINE PATIENT WAITED THE REQUIRED TIME OF 15 MINUTES AND LEFT.... Read more
AFTER RECIEVING THE COVID 19 PFIZER VACCINE PATIENT WAITED THE REQUIRED TIME OF 15 MINUTES AND LEFT. ABOUT 30 MINS LATER PATIENT COMES BACK COMPLAINING OF TINGING AND ITCHING OF THROUT AND BODY. PATIENT HAS NO BREATHING ISSUES. I CHECKED HER BP AND PULSE BOTH WITHIN NORMAL RANGE. SHE SAT FOR A FEW MINUTES AND STILL HAD THE TINGING AND ITCHING SO I THEN GAVE HER AN INJECTION OF DIPHENHYDRAMINE AND OBSERVED HER FOR 30 MINS. ALL SYMPTOMS SUBSIDED AND PATIENT FELT BETTER. I ADVISED HER TO NOT DRIVE SHE CALLED HER MOTHER TO PICK HER UP. PATIENT REFUSED TO GET CHECKED BY EMS.
44 2021-04-15 pain in extremity, tenderness headache, muscle aches, armpit tenderness, arm soreness, congestion, fatigue, nausea
44 2021-04-15 pain in extremity Metallic taste in mouth Very sore arm
44 2021-04-15 pain in extremity 4/15 Woke up with sore arm, to be expected, had full body aches, chills, brain fog, trouble concentr... Read more
4/15 Woke up with sore arm, to be expected, had full body aches, chills, brain fog, trouble concentration, extremely tired. Had a fever of 100 degrees. Felt like really bad flu symptoms. Slight headache. Just mostly extremely tired and hurt all over. Woke up on 2nd morning after the shot, 4/16 with no more pains or discomfort.
44 2021-04-15 tingling Developed aching joints, fatigue and headache within 12 hours of injection. Conditions worsened. Fev... Read more
Developed aching joints, fatigue and headache within 12 hours of injection. Conditions worsened. Fever off 100.6 within 24 hours. Fever disipated to 99.6 by 9 pm, severe headache persisted. Took Tylenol. Headache disipated by 1 AM. Developed pins and needles in arms, legs, chest, neck. Symptoms of pins and needles continues but comes and goes. This is day 4 after vaccination.
44 2021-04-15 tenderness 4/13/21 Started to become fatigued by 5pm on date of vaccine..by 8 pm I was in extreme pain, all my... Read more
4/13/21 Started to become fatigued by 5pm on date of vaccine..by 8 pm I was in extreme pain, all my joints hurt, by 2 am developed a very large lump underneath my left armpit. I?m assuming it?s my lymph nodes..I was unable to lift my arm until 4/16/21.. Pain subsided on 4/15-4/16..With lingering fatigue. 4/16..lump underneath armpit is still there and tender to touch.
44 2021-04-16 migraine Migraine headaches
44 2021-04-16 pain in extremity Sore arm. Swollen lymph node in right underarm with pain
44 2021-04-16 pain in extremity Neck,shoulder, back,leg pain. Armpit and under arm pain radiating to elbow Pain at injection site ... Read more
Neck,shoulder, back,leg pain. Armpit and under arm pain radiating to elbow Pain at injection site down to fingers Dizzy, difficulty focusing with black spots lasting a few hours
44 2021-04-16 tingling, numbness Within 5 minutes of receiving the vaccine, I felt tingling and slight numbness or pins and needles f... Read more
Within 5 minutes of receiving the vaccine, I felt tingling and slight numbness or pins and needles feeling in my left face/cheek. Today I have the same sensation and some in my left side of my tongue and lip. The only other reaction is pain at the injection site .
44 2021-04-17 flushing Pt was feeling flushed. Reports a history of hypertension and anxiety. Blood pressure 163/93, reduc... Read more
Pt was feeling flushed. Reports a history of hypertension and anxiety. Blood pressure 163/93, reduced ten min later to 156/90. Pt reports not having taken BP medication yet today.
44 2021-04-17 numbness Left arm and left side of tongue went numb within minutes of shot. Had some numbing sensation near i... Read more
Left arm and left side of tongue went numb within minutes of shot. Had some numbing sensation near injection site for 3 days.
44 2021-04-17 pain in extremity Day 1: Sore arm, back pain, headache Day 2: Sore arm, back pain, headache, neck pain, pain in both... Read more
Day 1: Sore arm, back pain, headache Day 2: Sore arm, back pain, headache, neck pain, pain in both calves, increased joint pain, low grade fever
44 2021-04-17 tenderness, pain in extremity Moderate to severe left arm pain/ tenderness. Mild joint stiffness and mild joint pain in left han... Read more
Moderate to severe left arm pain/ tenderness. Mild joint stiffness and mild joint pain in left hand. Mild fatigue, mild mental fog.
44 2021-04-18 weakness Right shoulder and upper arm weakness, decreased strength since receiving vaccine. Full range of ... Read more
Right shoulder and upper arm weakness, decreased strength since receiving vaccine. Full range of motion still intact. No pain but some discomfort when arm is raised above shoulder height and when arm is outstretched and rotated anteriorly. Unsure of exact notice of onset; at first just thought that the area was still sore post-injection but has not gotten any better and, in fact, the weakness is slightly more pronounced as time progresses. No official medical diagnostics completed, just symptom assessment. I am a 20+ year RN (and am actually contracted with the local health department to be giving Covid vaccines). I am doing some range of motion exercises with that joint/area and some light strength exercising to prevent further weakness. ***Of important note, the vaccine was not administered 2 finger-widths below my acromion process with good placement in the deltoid - it was given very high toward my shoulder.***
44 2021-04-18 weakness Got the 1st Pfizer vaccine on 4/10. Started getting dizzy with vertigo and nausea 4/14. Have missed ... Read more
Got the 1st Pfizer vaccine on 4/10. Started getting dizzy with vertigo and nausea 4/14. Have missed worked. Cannot stand up for more than a minute or two before the vertigo gets debilitating. Have been in bed, dizzy, for 7 days straight.
44 2021-04-18 grand mal seizure, seizure I had a seizure and fell out of bed between the night of March 12th and the morning of March 13, 202... Read more
I had a seizure and fell out of bed between the night of March 12th and the morning of March 13, 2021. I injured my face badly as well as my eye. I had to go to the Emergency room here on 3/16/21. I had a second seizure at the entrance to event on Saturday March 27, 2021 . It was a grand mal, clonic-tonic seizure. I was life flighted to Medical center on March 27, 2021 I was not discharged until 3/31/21.
44 2021-04-18 pain in extremity I had a off and on temperature/fever, chills, total body fatigue, headache, nausea, sinus and eye pa... Read more
I had a off and on temperature/fever, chills, total body fatigue, headache, nausea, sinus and eye pain, and intense arm pain in vaccination arm (right) the day following the 2nd vaccination dose. On the second day my temperature regulated but I still had a headache, nausea, body fatigue. Noticed heart palpations intermediately throughout the day, while moving, lying down and sitting. On the third day still had a slight headache, slim body fatigue and noticed more consistent heart palpations. Also started my menstruation cycle on Saturday as well. Experienced more intense menstrual cramps than normal. It's the fourth day now and still feel the heart palpations more sporadically than yesterday and intense menstrual cramps. Please note that I already had a irregular heart beat prior too covid but I noticed a significant increase in the occurence of the heart palpations. Normally I only have them once a month or once very few months. This has been several times a day and on Sunday seemed to be experiencing hourly.
44 2021-04-19 numbness and pain in extremities, tingling, pain in extremity mild symptoms of COVID toes after first vaccine, but much worse and still enduring after second vacc... Read more
mild symptoms of COVID toes after first vaccine, but much worse and still enduring after second vaccine. Blue toes, tender toes, sx of pain, swelling and pins and needles consistent with peripheral neuropathy.
44 2021-04-19 pain in extremity Sore arm
44 2021-04-20 facial pain Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Int... Read more
Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Intense headache, neck, facial and cranial pain; Extreme vertigo within 1 hour; loose stool; Nausea; vomiting; Swollen; itchy hives; itchy hives; Swollen left eye; This is a spontaneous report from a contactable HCP and a consumer (the patient). A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as single dose for covid-19 immunisation . Medical history included migraine, demyelination , post-traumatic stress disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced immediate left side (injection side) headache. on 03Apr2021 11:45 with outcome of not recovered , intense headache, neck, facial and cranial pain on 03Apr2021 11:45 with outcome of not recovered , extreme vertigo within 1 hour on 03Apr2021 11:45 with outcome of not recovered , loose stool on 03Apr2021 11:45 with outcome of not recovered , nausea on 03Apr2021 11:45 with outcome of not recovered , vomiting on 03Apr2021 11:45 with outcome of not recovered , swollen on 03Apr2021 11:45 with outcome of not recovered , itchy hives on 03Apr2021 11:45 with outcome of not recovered , swollen left eye on 03Apr2021 11:45 with outcome of not recovered. All the reported events were considered Important Medical Events. Course of the event: Immediate left side (injection side) headache. Spread to entire head within 30 minutes. Intense headache, neck, facial and cranial pain persists at hour 53. Extreme vertigo within 1 hour, persisting now at hour 53. Nausea, vomiting and loose stool within 6 hours. Vomiting ceased at 48 hours post 1st shot vaccination. Nausea and diarrhea persists at hour 53. Swollen, itchy hives, injection side within 40 hours, spread to neck and face. Swollen left eye, within 24 hours, waning at hour 53. No follow-up attempts are needed. No further information is expected.
44 2021-04-20 severe one side paralysis left sided hemiplegia, found down 4/20 @3:30pm, found to have left ICA territory stroke with M1 occl... Read more
left sided hemiplegia, found down 4/20 @3:30pm, found to have left ICA territory stroke with M1 occlusion, outside of window for tPA and thrombectomy, underwent decompressive hemicraniectomy
44 2021-04-20 numbness Numbness of small area of left cheek. Felt similar to numbness from dental work as it?s wearing off.... Read more
Numbness of small area of left cheek. Felt similar to numbness from dental work as it?s wearing off. I could still move my face. Started right after the 15 minute mark and Was slightly numb until the next day. Resolved with no treatment. Did not report to a doctor.
44 2021-04-20 pain in extremity 3 hours after getting the 1st vaccine, I noticed a loud ringing in my right ear. I then got very diz... Read more
3 hours after getting the 1st vaccine, I noticed a loud ringing in my right ear. I then got very dizzy so I laid down. I then got very nauseous. After about another 30-45 minutes later I vomited. I slept for a few hours after that and then did not feel dizzy or nauseous anymore. My left arm was very sore for 3 days. To this day, I still have a loud ringing in my right ear. .
44 2021-04-20 tingling tingling in arms and legs, headache, elevated HR, resolved, pt. left site.
44 2021-04-20 tingling 15 minutes after the 2nd dose was given, my left hand was tingly like it had fallen asleep. By the ... Read more
15 minutes after the 2nd dose was given, my left hand was tingly like it had fallen asleep. By the time I got to my car, maybe 5 minutes, it was back to normal. It continues to do this randomly for about 5 minutes or so before it stops. It's only ever my left hand. It doesn't hurt but it's random and continues to happen. I didn't think anything of it until my husband had his second shot on 4/19 and his hand did the same thing on the evening of 4/20.
44 2021-04-20 speech disorder On day 5 after my first shot I experienced extreme brain fog. I was struggling to find words and my... Read more
On day 5 after my first shot I experienced extreme brain fog. I was struggling to find words and my mind will completely blank out in the middle of speaking a sentence. I have a difficult recalling and retaining new information. My symptoms worsened as the week went on and continues to be an issue 3 weeks after my first shot although the severity is lessening daily.
44 2021-04-20 tremor, pain in extremity, feeling of body temperature change, discomfort At 2am, 12 hours after shot woke up with severe chills and couldn?t get out of bed. Took Advil a and... Read more
At 2am, 12 hours after shot woke up with severe chills and couldn?t get out of bed. Took Advil a and Tylenol to sleep. Woke up next morning and took Tylenol at 8am so I could try to have a normal day. Held off on medicine but started to feel exhausted and got hot / shaking chills again at 3pm and could not get warm . Took a nap to try to avoid medication but then took Advil/Tylenol again at 5pm because my fever reached 103 and I was too uncomfortable. Fever broke an hour later and I was able to sleep all night. Felt 90% better in morning and pretty normal by 48 hours after shot though continued to have fatigue and some periodic nausea into following day and one instance of diarrhea. Also arm was sore.
44 2021-04-21 discomfort Shingles. On day 12 after the second shot of Pfizer Covid 19 vaccine, felt discomfort and a sensati... Read more
Shingles. On day 12 after the second shot of Pfizer Covid 19 vaccine, felt discomfort and a sensation that something was rubbing against the skin around the waistline. On day 16 developed a rash with red blisters on the left side of the waist.
44 2021-04-21 flushing Pt reported "Flushing and heart racing"
44 2021-04-21 numbness On April 4th at approximately 8:00am, I blacked out while I was walking to use the restroom, and lan... Read more
On April 4th at approximately 8:00am, I blacked out while I was walking to use the restroom, and landed face first on the kitchen floor. When I came to, my nose was bleeding and my right arm was numb. My husband called my doctor (and spoke with the doctor on call) who told me to go to the ER. While at the ER, the doctor ran an EKG, CT, and labs. All tests came back fine. I have had a headache, neck pain, and have felt light headed ever since. I returned to the ER a week later with a severe headache. Another CT, EKG, and chest x-ray. All results were fine. I have also seen a neurologist and a cardiologists. All tests came back fine. I still have a constant headache and feel light headed.
44 2021-04-21 pain in extremity The day of the first shot, I developed soreness in my arm, headache, fatigue. The next day, my side ... Read more
The day of the first shot, I developed soreness in my arm, headache, fatigue. The next day, my side effects continued and worsened. On 4/4/21, my symptoms continued and I developed more fatigue, fever, nausea, chills, early period, and abdominal pain. On 4/5/21, these side effects continued and the abdominal pain increased. On 4/6/21, ER determined that I developed acute appendicitis. My appendix ruptured and I had to have an appendectomy.
44 2021-04-22 feeling cold, feeling hot Flulike symptoms (chills, muscle aches, joint aches, hot and cold spells) beginning 4/21 around 10 p... Read more
Flulike symptoms (chills, muscle aches, joint aches, hot and cold spells) beginning 4/21 around 10 pm resolved by 4/23 AM Arm soreness at injection site beginning 4/21 evening and resolved 4/23 am.
44 2021-04-22 feeling hot After immunization she complained of feeling warm and nauseated. She transported to emergency care.
44 2021-04-22 numbness, tingling Site: Pain at Injection Site-Severe, Systemic: Vomitting, numbness and tingling in arm radiating to ... Read more
Site: Pain at Injection Site-Severe, Systemic: Vomitting, numbness and tingling in arm radiating to shoulder blade-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Pt reported arm pain, severe enough to warrant us to administer her 2 extra strength acetaminophen (500mg each). Approx 20 min later, she started vomiting. She seemed alert and oriented, reported pain in her arm, numbness radiating to her shoulder blade. BP was checked at 4:30P 148/98 HR100. Pt had more vomiting after about 5 mins, administered bendadry 25mg 1 tablet, vomiting continued. Called Dr's office, they recommended she proceed to the ER. We called the ambulance to carry her
44 2021-04-22 pain in extremity Sore arm, body/muscle pains, diarrhea, mild nausea. Had confirmed COVID-19 in Oct 2020 (positive PC... Read more
Sore arm, body/muscle pains, diarrhea, mild nausea. Had confirmed COVID-19 in Oct 2020 (positive PCR test and positive antibodies confirmed), and the vaccine side effects are far worse than the original illness, which produced only loss of taste and smell.
44 2021-04-22 tingling WIthin one minute I had difficulty breathing, heart racing, pins and needles in my fingers, hands, ... Read more
WIthin one minute I had difficulty breathing, heart racing, pins and needles in my fingers, hands, arms up into my neck and in my face. I felt faint like I would pass out.
44 2021-04-23 feeling hot, tingling, cold extremities Pt. had lightheadedness and had patches of redness on her chin , neck and cheeks, . No difficulty b... Read more
Pt. had lightheadedness and had patches of redness on her chin , neck and cheeks, . No difficulty breathing and no pruritis noted . On litter in OBs 1 she was C/O her Lt. arm feeling cold and her Lt Hand , at one point she had a metallic taste in her mouth and " prickely" feeling in her cheeks . She also was shivering when she arrived, That subsided and her face felt hot. Benadryl was offered but refused. Her first vs was 2:28 p-116, resp 20, bp, 166/105 Po2 94%. She was discharged ambulatory with her husband after her vs stabilized.
44 2021-04-23 numbness, feeling hot, tingling Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial are... Read more
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling and numbness to all four limbs began within 5 minutes of vaccination, after 30 minutes of being monitored of most of the tingling went away except for her feet which she felt warmer then usual.
44 2021-04-23 pain in extremity Swollen arm and swollen lymph notes / armpit in left arm Pain in arm and armpit
44 2021-04-23 pain in extremity 24h post-injection: tired, injection arm very sore, painful to move 48h post-injection: no symptoms,... Read more
24h post-injection: tired, injection arm very sore, painful to move 48h post-injection: no symptoms, arm soreness decreased from 36h onwards 64h post-injection: large hive at injection site and smaller hives around injection site; itchy, also body is itchy, mainly head and back (besides injection region), no hives or rash on head, back, or rest of body as of now
44 2021-04-23 pain in extremity Tiredness, nausea, and arm pain
44 2021-04-23 sensory loss Pt was seated to receive a vaccine. She received the injection from who is working the event and di... Read more
Pt was seated to receive a vaccine. She received the injection from who is working the event and did attend orientation on how to prep and administer the vaccine. Pt sts as soon as she was given the injection, she felt a very mild "sensation" in from her R hand to her R cheek and ear. She sts is just "so mild" she thought she might have been imagining it at first but it is now getting worse. She reports it feels like a mild sensation. She passed her 15 minute time wait as precaution for allergic reactions and went to the restroom. At 19 minutes after her dose was given, she reported it to the adverse reaction/signs and symptoms team. Pt sts it is slightly worse when she moves her arm but is still "quite mild". Vitals are stable and PMS is intact X4. Pt is given VAERS info and notified that event would be reported by medical staff on site. Pt sts she will follow up with her PCP. Vitals during assessment are BP 125/81, HR 76, Sats 98%, RR 14
44 2021-04-23 tenderness Clinical signs noticed upon waking the day following vaccination #2. Flu-like symptoms: cold chills,... Read more
Clinical signs noticed upon waking the day following vaccination #2. Flu-like symptoms: cold chills, joint and muscle aches, headache, general malaise, tenderness in left axillary region, loose stool
44 2021-04-24 burning sensation Rash on body. Burning and itching. Abdominal pain.
44 2021-04-24 tingling, hypersensitivity of all senses PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't star... Read more
PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't started; symmetrical lumps on the distal sides of my breasts; faint; slight injection site soreness; intense tingly whole body sensations; Sense of pressure and tingling on eyeballs; Increased sensitivity to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Mar2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Mild/moderate TBI in Oct1999 with herniated disk in lower lumbar region from auto accident (patient was a pedestrian and a car ran into her); fractured tibia/fibula from occurrence; low blood pressure which she had occasionally fainted from at blood draws (started after being active athletically during recovery from 1999 injury). Patient was not pregnant. There were no concomitant medications (no vaccine in 4 weeks and no other medication in two weeks). Patient did faint 15 minutes after receiving Pfizer Covid vaccine on 30Mar2021. Medical people at vaccination site made a vasovagal note on record. Patient reported that there were no body aches or fatigue or fever, only slight injection site soreness for a couple of days which was hard to notice through intense tingly whole body sensations that started after receiving vaccine on 30Mar2021 16:15. Still continuing to feel a week and a half later. It was very uncomfortable but not painful. Patient also experienced sense of pressure and tingling on eyeballs and increased sensitivity to touch. Menses were due one week after vaccination but 4.5 days after vaccination on 03Apr2021, nipples became very hard and sore. After a few days on nipples slightly sore still but mostly swollen breast tissue with soreness on Apr2021. Patient had not had this as PMS symptom since becoming pregnant almost 9 years ago and it never lasted 7.5 days with it still ongoing as of time of report. Her menses was late on Apr2021 and hasn't started but she was not pregnant. Patient's usual PMS symptoms have kind of started yesterday on 09Apr2021. It quickly formed bilaterally symmetrical lumps on the distal sides of her breasts which was also unusual on Apr2021. No treatment was received and events results in doctor's clinic visit. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event syncope and the suspect suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-04-24 tingling, numbness 4/21 at 12:40pm: Face felt tingly/numb. That went away after a few hours. 4/22 1AM Fever, chill... Read more
4/21 at 12:40pm: Face felt tingly/numb. That went away after a few hours. 4/22 1AM Fever, chills, body aches. Stayed in bed for 30 hours 4/23 12PM I started feeling better and moving around but numbness and tingling in my right leg and foot which i thought was because i had been resting did not go away. 4/23 5PM I also noticed a blue spot on my right foot. I went to a stand alone ER and they check for blood clots and stroke and just sent me on my way and said to take Ibuprofen. 4/24 Same tingling and numbness in right foot/leg and now heavy and weak arms along with headache and nausea. 4/25 Leg feels back to normal and the numbness and tingling has moved to the left arm. The tingling and numbness can be felt running down the side of my arm into my pinky.
44 2021-04-25 facial pain 24 hours after my second covid vaccine I came down with a very intense headache like many; it was de... Read more
24 hours after my second covid vaccine I came down with a very intense headache like many; it was deep in my eye sockets, my ears, jaw, and teeth, a radiating, pulsating type pain. By the next morning I was better. That night, April 11, I was awoken in the middle of the night with the same kind of pulsing pain in my teeth. It became progressively worse over the next two weeks to the point where I could not rest my top and bottom teeth together or eat any kind of solid food. By Monday April 19, I went to an urgent care clinic to see if there was anything wrong with my sinuses, nothing (the doctor said at the time that if it wasn't my teeth that I should see an ENT). At this point I was taking 800 milligrams of ibuprofen every 4 hours and slathering my teeth with orajel numbing gel. By 4/21 I was able to get an emergency appointment with my dentist- she did x-rays and saw nothing. She said if the pain continued for another 2 weeks she would send me to a root canal specialist. She also encouraged me to wear a mouth guard to help. By Friday, my 2 weeks after my 2 shot, I was able to get through the day without medication. Today is Monday 4/26 and while I am almost fully better, the teeth are still sore and I can only eat mushy solid foods.
44 2021-04-25 feeling cold, feeling hot severe hot and cold chills a few hours after the vaccine then flu like symptoms, high temperature so... Read more
severe hot and cold chills a few hours after the vaccine then flu like symptoms, high temperature sometimes reaching 104, sore body, hot and cold, burning skin, hardly able to move swollen lymph nodes under armpit on same side as vaccine (left) metallic taste in mouth day 2,3,4
44 2021-04-25 numbness My left arm has numbness that won't go away and hasn't decreased since I noticed it.
44 2021-04-25 pain in extremity, numbness Numbness started in left arm then spread to left leg. Pain back of left shoulder and under side of p... Read more
Numbness started in left arm then spread to left leg. Pain back of left shoulder and under side of proximal left upper arm. Pain distal hamstring. No pain at injection site.
44 2021-04-25 tingling, pain in extremity, numbness Pfizer-BioNTech COVID-19 Vaccine EUA The vaccine was administered around 1:25 within 10 minutes I h... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA The vaccine was administered around 1:25 within 10 minutes I had tingling in my finger. That was all & I was released. At about 1:55 I noticed tingling in my cheek & lips on the left side...numbing like done at the dentist. On the advice of a friend who is a nurse, I took Benedryl a few minutes later & drove back to the hospital to be observed. It only stayed on the left side of my face. My throat was not a concern at all. I was released again around 2:15 after consulting with the Dr on call. By 3:15 my lips were pretty much better but the cheek still had some numbing. I took another Benedryl later that evening (probably about 8 or 9) It felt heavy through out the remainder of the day & into the next day. But mid day the following day all symptoms were gone even the sore arm.
44 2021-04-26 numbness, tingling Pins and needles and numbness in both feet and pin s and needles in calves off and on for a week and... Read more
Pins and needles and numbness in both feet and pin s and needles in calves off and on for a week and ongoing.
44 2021-04-26 pain in extremity, numbness 45 year old Asian woman with history of Rheumatoid Arthritis and Anxiety developed right arm numbnes... Read more
45 year old Asian woman with history of Rheumatoid Arthritis and Anxiety developed right arm numbness and pain approximately 10 minutes after receiving her first Pfizer Covid vaccine. She also complained of nausea and vomited up a small amount of stomach contents. No rash, no neurologic changes, no shortness of breath. After she took her own Zofran 4 mg po, her nausea cleared. She was observed for 45 minutes and the pain and numbness in her right arm resolved.
44 2021-04-26 pain in extremity Fever 99.8 from the night got the vaccine through next morning. Taking ibuprofen reduced the fever. ... Read more
Fever 99.8 from the night got the vaccine through next morning. Taking ibuprofen reduced the fever. Arm sore after fever, got red and swelling and haven?t gone after 4days now
44 2021-04-26 pain in extremity larger red and swollen itching injection spot; patient had larger red and swollen itching injection ... Read more
larger red and swollen itching injection spot; patient had larger red and swollen itching injection spot; patient had larger red and swollen itching injection spot; tired; sore arm; nausea tired; Earache; headache; This is a spontaneous report from a contactable consumer (Patient) reported for himself. A 44-years-old female (Non-Pregnant) patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6203, Expiration date: unknown), via an unspecified route of administration in left arm on 24Feb2021 at 11:30 AM (at age of 44years) at single dose for COVID-19 immunization. Patient medical history included which was acid reflux. Patient had Known allergies to gluten, food sensitivity to dairy and tomatoes. Patient concomitant medications included esomeprazole (20mg) two times in daily, vitamin B12 (5000mcg). Patient did not receive any vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 24Feb2021 at 12:00 the patient experienced headache, nausea, earache and on 25Feb2021 second day patient had sore arm headache and tired, on 26Feb2021 (day 3) the patient had red, swollen, and itching at vaccination site also, tired, nausea. and on 27Feb2021 (day 4) the patient had larger red and swollen itching at vaccination spot nausea tired. Patient didn't take treatment for the events. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
44 2021-04-27 burning sensation, tremor Extreme body aches 10/10 pain scale. Felt like my whole body was on fire, or as if I had a sunburn a... Read more
Extreme body aches 10/10 pain scale. Felt like my whole body was on fire, or as if I had a sunburn and someone was rubbing it. Lasted 4 days. Tremors lasted 1 day. Fever 1 day. Headache 6 Days and counting. Extreme fatigue 6 days and counting. Tightness in my chest 6 days and counting. Chills 3 days. Bouts of extreme sweating 3 days. Upper body soreness 6 days and counting "COVID fog" 6 days and counting. It basically felt like I had COVID-19 all over again, only this time the pain was much worse. I had COVID beginning 10/19/2020.
44 2021-04-27 feeling hot, pain in extremity I received the shot and went back out to sit down. I started feeling really sweaty to the point that... Read more
I received the shot and went back out to sit down. I started feeling really sweaty to the point that I had to fan myself. My husband went to get me a bottle of water and my daughter was talking to me and while she was midsentence , everything went black, then all went back to normal but she was done speaking so I think I blacked out. This happened 3 times. No issues breathing. Just hot and dizzy. We went home and I took a nap as I was feeling fatigued and woke up about 3-4 hours later. Sore arm the rest of the day and I got up the next day feeling ok. Just more tired than usual since.
44 2021-04-27 numbness, flushing, tingling I had Bell?s palsy type symptoms within 45 minutes one eyebrow raised higher than the other. My face... Read more
I had Bell?s palsy type symptoms within 45 minutes one eyebrow raised higher than the other. My face felt numb, tingled. Towards the evening my face was flush red, I looked like I had a chemical peel and it was streaking. Facial swelling. My hands looked like they were very read on the palms.
44 2021-04-27 muscle spasms, breast pain the 2nd covid shot affected my menstrual system. The last day of my period was 04/12/2021, yet only ... Read more
the 2nd covid shot affected my menstrual system. The last day of my period was 04/12/2021, yet only 2 days later I started experiencing headaches, extremely sore and heavy feeling breasts, tender nipples, bloating, gas, cramps, fatigue, muscle aches, moodiness, sadness -- all of the symptoms that usually occur a few days before my period begins. It has been two weeks since the 2nd shot and all of these symptoms are still persisting. I don't know if my period will come early, or if I will just continue having these symptoms until my period starts, (if it starts on time), or when the symptoms will stop.
44 2021-04-27 pain in extremity Fever of 101, chills, body aches, tired, arm pain. Fever last for about 10 hours, felt better by e... Read more
Fever of 101, chills, body aches, tired, arm pain. Fever last for about 10 hours, felt better by early morning on April 28th.
44 2021-04-27 tenderness Experienced fever, chills, dizziness and vomiting within one hour of shot. severe reaction came ar... Read more
Experienced fever, chills, dizziness and vomiting within one hour of shot. severe reaction came around midnight with very painful skin. Not muscle aches like with the flu but all my skin was painful to the slightest touch. All over my body. Even my face. An excruciating pain. It was even hard to put clothes on. No rash. No skin peeling. I had not heard of this as a side effect and thought it should be brought to your attention. Severe skin pain lasted about 10 hours and then lessened and about 36 hours is now gone.
44 2021-04-27 tenderness Extremely swollen armpit lymph node, very tender. Tiredness, body muscle aches, headache
44 2021-04-28 cold sweat clammy, swollen left cheek, difficulty swallowing, upper arm (site of injection) had no feeling
44 2021-04-28 numbness I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't wal... Read more
I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't walk; my immune system attacking the nerves; The shortness of breath is very bad; My pulse is high; My blood pressure is low; I have major neurological symptoms now.; My left eye is now affected too and blurry.; keep feeling my face and now my tongue and mouth go numb; keep feeling my face and now my tongue and mouth go numb; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the second dose. A 44-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the right arm via unspecified route on 03Apr2021 (at 44-years-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot unknown expiry information not provided) in the left arm on 13Mar2021 at 12:00 (at 44-years-old) and experienced face, head and ears started tingling, shortness of breath, numbness and weakness, severe burning all over her nerves of her body, and abnormal uterine bleeding. The patient denied any known allergies and being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and the patient denied receiving any other vaccine within four weeks of this vaccine. The patient reported that on 03Apr2021 she received her second shot and within four hours her left leg went completely numb and she could not walk. The patient reported that she went to the emergency room three times since that time. The patient reported that she was told it was her immune system attacking her nerves. The patient reported that the shortness of breath is very bad, her pulse is high, and her blood pressure is low. The patient explained that she has major neurological symptoms now. The patient stated that she has had two magnetic resonance imaging (MRI), on computerized tomogram (CT) and two x-rays though no results were provided. The patient explained that she has appointments with neurologist and immunologist. She is unable to work since she has to be on video with people and keep feeling my face and now her tongue and mouth go numb. The patient stated that she was scared to eat food, so she does not choke. The patient mentioned that her left eye is affected too and blurry. The patient exclaimed that she cannot function, it is scarring her little kids and has affected her entire family. The patient reported that events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage]; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the events left leg went completely numb, could not walk, immune system attacking her nerves, shortness of breath, pulse is high, blood pressure is low, neurological symptoms, unable to work/ cannot function, feeling my face and now her tongue and mouth go numb, and left eye is affected too and blurry, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) :-PFIZER (Same reporter/patient/product, similar events with first dose)
44 2021-04-28 pain in extremity Muscle aches, sore arm, heavy and painful period, sluggish
44 2021-04-28 tremor Pt became shaky, lightheaded immediately following vaccine Pt was given water, laid down=resolved sx... Read more
Pt became shaky, lightheaded immediately following vaccine Pt was given water, laid down=resolved sx Vitals @1250 HR 87, Resp 18, BP 148/97 O2 97% 1305 HR 89 BO 137/92, O2 100% 1318 HR 85 BP 143/101 O2 100% Pt sent home at 1315-self
44 2021-04-29 numbness On day on injection, experienced numbness on left side of lips and lower face. On day 6 (4/30/2021)... Read more
On day on injection, experienced numbness on left side of lips and lower face. On day 6 (4/30/2021), woke up with a large red rash at injection site.
44 2021-04-29 pain in extremity After administration of 1st covid vaccine, pt immediatly felt a pull/pain in her right leg. Left leg... Read more
After administration of 1st covid vaccine, pt immediatly felt a pull/pain in her right leg. Left leg pain continued for 2 weeks. Pt went to doctor, and diagnosed her with superficial phelbitis and was given ^600 mg Ibuprofen for pain. Ibuprofen did not help, only icy hot relieves pain. Deffered pt to wait to get second dose until leg pain has subsided.
44 2021-04-29 pain in extremity Immediate burning at injection site. Pain in arm. Pain then traveled up into neck and down my side a... Read more
Immediate burning at injection site. Pain in arm. Pain then traveled up into neck and down my side along ribs. Next day (today) body aches and fever, still occurring.
44 2021-04-29 pain in extremity Arm pain after 12 hours, unable to lift arm. Fatigue and mild body aches 12-24 hours after vaccine.... Read more
Arm pain after 12 hours, unable to lift arm. Fatigue and mild body aches 12-24 hours after vaccine. 24-36 hours after vaccine fever of 101, extreme body aches, chills and headache with nausea.
44 2021-04-29 tingling Dizziness one hour after second vaccine on the next day sore arm at side of vaccine and drowsiness t... Read more
Dizziness one hour after second vaccine on the next day sore arm at side of vaccine and drowsiness tiredness. On Monday afternoon noticed lymph node in front of right ear opposite side of vaccine was swollen on Tuesday notice that there was fluid swelling directly under my right knee went to the doctor they said to monitor symptoms Thursday woke up to swelling in face on the left side between nose and cheek. Today feeling tinglingness in both legs hands and swelling continues in face right lymph node in front of ear is not as large.
44 2021-04-29 seizure Seizures lasting for 10 days. The first 3 days experienced 1 per day. The next 4 days experienced mu... Read more
Seizures lasting for 10 days. The first 3 days experienced 1 per day. The next 4 days experienced multiple. Ended up at hospital. Treated there in neurology. The next three days experienced one per day. Then they stopped. And I felt completely back to normal. Resumed normal exercise and daily activities.
44 2021-04-29 seizure Seizures/Spells. Two days after the vaccine injection I started having seizures/spells. It started w... Read more
Seizures/Spells. Two days after the vaccine injection I started having seizures/spells. It started with 1 a day for 2 days then increased to multiple spells per day (up to 4-5) I was seen at clinic neurology on April 13th. While there they called Emergency Services and I was transported to Emergency Department for what they believed to be prolonged seizure activity. Dismissed from there with appointment with Dr. who is looking into adverse reactions to Covid vaccine and referral to clinic. After 13 days recovered completely and back to normal activity and workouts.
44 2021-04-29 tremor shakiness after second Pfizer mRNA COVID-19 injection IM in left deltoid. Vitals taken (WNL) and sna... Read more
shakiness after second Pfizer mRNA COVID-19 injection IM in left deltoid. Vitals taken (WNL) and snacks and juice given before vaccine. Patient felt better and wanted to receive vaccine. Gave vaccine and monitored for 30 minutes in the observation area. Patient felt shaky, so given more snacks and monitored vitals again and sent to urgent care for evaluation. Symptoms resolved in urgent care without intervention. Instructed patient to go eat a good lunch and return if symptoms return or worsen.
44 2021-04-30 burning sensation, nerve pain, tingling, weakness, numbness Uterine abnormal bleeding for 7 days; My face, head and ears started tingling; Shortness of breath; ... Read more
Uterine abnormal bleeding for 7 days; My face, head and ears started tingling; Shortness of breath; Numbness; Weakness; Severe burning all over my nerves of my body; Severe burning all over my nerves of my body; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the first dose. A 44-year-old adult [non-pregnant] female received the first dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the left arm via unspecified route on 13Mar2021 at 12:00 (at 44-yeasr-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient denied any known allergies as well as being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and receiving any other vaccine within four weeks of this vaccine. The patient reported that on 13Mar2021 at 16:00 she experienced her face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body. On 14Mar2021, the day after the vaccine, the patient developed abnormal uterine bleeding. The patient reported that events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the abnormal uterine bleeding was recovered on 21Mar2021 after seven days. The outcome of the events face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021413774 PFIZER (Same reporter/patient/product, similar events with second dose)
44 2021-04-30 numbness, limb paralysis Approximately 30 minutes after vaccination: shooting pains in right side of chest and down right arm... Read more
Approximately 30 minutes after vaccination: shooting pains in right side of chest and down right arm. Approximately 5 hours after vaccination: numbness in right pinky and palm of hand: spreading up arm over the course of 1hour. Approximately 6 hours after vaccination: severe headache. Took Aleve for pain. 10 hours after vaccine (midnight) injection site pain increased in right shoulder. Very uncomfortable, but bearable. Placed heating pad on before bed. Next morning: woke at 9:30am. Felt pain in upper arm. No medication. Monday evening: pain in shoulder/arm. Sharp pain in elbow radiating up and down arm. This pain/numbness in right arm, shoulder, hand, chest and back has been coming and going for over 2 weeks. - [ ] Over a week and a half later, (Tuesday) awful sharp pain in right index finger. Came on suddenly. Lasted about an hour or two. - [ ] Wednesday, felt sudden neck/arm/back/chest pain on right side. Not when I woke up, but later in the day. Came on suddenly. Felt shooting pain in chest. Whole arm felt sore and stiff. - [ ] Arm/neck/shoulder/back pain on right side still lingering on Friday. Feels more dull and achy most of the day with sudden flare ups at times. Friday night: 2 weeks after vaccination, pain was so intense I was unable to sleep. Placed heating pad on arm and back shoulder. Numbness in arm/hand continues.
44 2021-04-30 numbness, cold extremities My left arm is getting numb and then gets normal and then gets numb again every hour Sometime every ... Read more
My left arm is getting numb and then gets normal and then gets numb again every hour Sometime every two hour and then half hour and then my left hand feels very cold specially my fingers and then I feel normal it?s a very strange feeling All night long on and off
44 2021-04-30 migraine Headache first day. Soreness in shoulder where the shot was given for two days. I have never had m... Read more
Headache first day. Soreness in shoulder where the shot was given for two days. I have never had migraines, however I have had three debilitating migraine headaches since the vaccines. My menstrual cycles have always been normal, but since the vaccines my periods are about two weeks apart and I am flowing incredibly heavy, unlike ever before! I have a rash on my left butt cheek that won?t go away and it feels like I have a rectal hemorrhoid. I am have been super tired and no energy. Before the vaccines I was in great shape and very healthy!
44 2021-04-30 pain in extremity, tingling diagnosed with coronary vasospasm; chest pain for 10 minutes and it went down through her arm and sh... Read more
diagnosed with coronary vasospasm; chest pain for 10 minutes and it went down through her arm and she was nauseous and thought she could walk it off and she was fine and did that for 10 minutes and got sick and she had to go; it was a pressure, painful but pressure; arm a little sore; tired; weird taste in her mouth; got nauseous; tingling pins and needles in her bottom jaw; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 05Apr2021 11:30 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. She added it is to protect herself and she takes care of her mom next month and she had hers and she also works with the public at store and it is the right thing to do to not keep spreading the awfulness. No prior vaccinations within 4 weeks and no additional vaccines administered on the same date as the COVID-19 Vaccine. Medical history included ulcer, irritable bowel with constipation, tired a lot and just that her doctor said to take a multivitamin and knows B and D are good, sinus infection 2-3 weeks ago and he told her to do sulfer antibiotics, risk factors of high blood pressure, overweight, and a smoker. Concomitant medication included linaclotide (LINZESS) taken for irritable bowel with constipation from an unspecified start date (started taking over 5 years ago) and ongoing; hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for high blood pressure from an unspecified start date (started taking over 15 years ago) to 10Apr2021 (stopped taking on 10Apr2021, her last dose was 09Apr2021); colecalciferol (VITAMIN D3) taken for an unspecified indication from an unspecified start date (started taking about 1 year ago, after Covid came out and fiance, tested him and it was low and takes because going around) and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for supplementation therapy (reported as tired a lot and just that her doctor said to take a multivitamin and knows B and D are good) from an unspecified start date (started about 6months ago) and ongoing; curcuma longa (TURMERIC [CURCUMA LONGA]) taken for as tired and heart healthy and she heard good things and thought she would try it from an unspecified start date (started about 6 months ago) and ongoing; vaccinium macrocarpon (CRANBERRY) taken for an unspecified indication from an unspecified start date (started 2-3 weeks ago) and ongoing. The patient also concomitantly took "Tantoprazole" (at 40mg once a day by mouth) started taking over 5 years ago and ongoing, states she took it that morning for ulcers; Dietary fiber (at 25 4 grams by mouth once a day) started taking over a year ago and ongoing after she lost her insurance and couldn't get the medication for her irritable bowel and was taking 2 a day and when she got insurance back and the medication back and still takes 1 a day and helps go to the bathroom; chewable immune support formula (by mouth daily) and ongoing and stated that it is like airborne, it has Vitamin C plus 13vitmains and she started taking this about 2 weeks ago VitC plus 13 vitamis started about 2 weeks ago; ongoing Culturelle Probiotic lactobacillus rhamnosus (40 mg) started over a year to a year and a half ago when she lost her insurance and had problems with irritable bowel with constipation and figured it can't hurt to keep taking. The patient added that she was not taking anything new, she has been on them a long time but will list in case the shot counteracts with a medication. The patient further added she was taking Lisinopril HCTZ for the last 15 years and has had high blood pressure for 20 years and was 1st on Capazoid and was changed to this. She states it is in a pharmacy filled see through bottle and the pill had BO3 on one side and LL on the other side. States she stopped taking it, her last dose was 09Apr2021 and the cardiologist switched her to 2 new medications. The Capazoid, she is not sure of spelling, was for about 5 years and it was Captopril and HCTZ and it was 15-20 years ago and she does not know the dose. It was also stated that she took her morning pills the day of the shot but didn't take her 3 afternoon pills. She went to the doctor for a sinus infection 2-3 weeks ago and he told her to do sulfer antibiotics and took that and she had problems going to the bathroom and the prescription for the UTI was too expensive so she got the over the counter and figured she would take Cranberry to keep it at bay. The patient does not know the name of the antibiotic, the dose, NDC, lot or expiry date states it was about 3 weeks ago. The pharmacist told her fiance that the over the counter was just as good as the AZO. It was also reported that the patient previously had prior vaccinations: sore arm with the flu shot, caller does not have name, dose, NDC, lot or expiry to provide. It was nowhere near the soreness from the Covid shot, it hurt to lift her arm. The patient can be heard asking if her fiance would like to make a report about being tired and having a sore arm after his shot. The patient and fiance decline to make a report. No further details provided. It was reported that the patient is calling to report the side effects she had with the 1st vaccine and what she went through after that and have it recorded and see if anyone else is having the same issue. She states if she can get answers that would be great. Her cardiologist can't confirm or deny if what she experienced was from the vaccine. States she had some immediately after and some happened a couple days later. States some of the stuff is on the sheet but not the severe stuff and if we have more information than when she got the sheet it would be great. The cardiologist she saw in the hospital that said he could neither confirm or deny that it is from the vaccine, states her primary is not aware of this. The patient states she didn't report right away as she didn't think it was a big deal and then she had big issues on Friday and she had the vaccine on Monday. The patient got the vaccine on Monday 05Apr2021, her appointment was at 10:35. The patient got the shot and right after the Band-Aid was placed a couple of minutes she got a weird taste in her mouth and she didn't say anything. She has donated plasma and knows there can be a metallic taste and it was just a shot and whatever it was a funny taste. She sat for the 15 minutes and was fine and got in her car and got nauseous and thought maybe she didn't eat so she started to drive and was calling her fiance to see what he wanted to eat. She started to get tingling pins and needles in her bottom jaw and that was weird to her and she told her fiance about it and got off the phone. She got to the place and ate and the nausea got a little better but she still had the tingling in her bottom jaw. She went home and laid down to take a nap. Shen she got up it was gone and everything was fine. The next day her arm was a little sore and she was tired but that is normal. Her fiance got his and he was tired and so she didn't think anything of it, she works 2 jobs, one at home and also at Target and her first day back was 09Apr2021. States most of the day she was fine but on her last break she was having chest pain for 10 minutes and it went down through her arm and she was nauseous and thought she could walk it off and she was fine and did that for 10 minutes and got sick and she had to go. Her manager and coworkers were worried about her so she went to the urgent care across the street and was told there that she was having signs of a heart attack with her risk factors of high blood pressure, overweight, and a smoker. They gave her 4 baby aspirin and did an EKG and that came back fine and was told she could go up to the ER if she wanted, she asked what that would do and was told they would run blood work. The patient states it was a pressure, painful but pressure. She asked him if this could have to do with the Covid vaccine she got Monday and he said he didn't know but probably not. She told him her symptoms she has listed, the taste, nausea, pins and needles in the jaw and he hung his head and shook it and told her that is another sign of heart issue. The patient went home and laid down for a nap and when she woke up the chest pain was still there and her fiance said she was going to the hospital since the aspirin didn't help and she could go by ambulance or by car. He took her to the ER Friday and they really thought she was having a heart attack and did tests like EKG and X-Ray and those were fine. It was stated that they did a T enzyme for your heart and it was .03 and they said they wanted it below that, that it wasn't bad. She had that test again and it went up so she had a catheter the next day and was told it was not clogged arteries. The patient stated she was diagnosed with coronary vasospasm. It was clarified the name of the test as Troponin and it was .03 and they wanted it below that and had her stay for observation and said it can go up and is a sign of heart damage and heart attack 6-24 hours after the initial pain. The patient stated they gave her nitroglycerin and that helped with the chest pain and it opened all the blood vessels. Throughout the night her Troponin levels went up. She had a cardio cath Saturday and the cardiologist was surprised he thought there was blockage and would place a stent and there was not blockage and nothing wrong. He explained that her blood vessels were so constricted that her heart spasmed as it was not getting enough oxygen and was causing the pain. She asked him if it could be from the Covid vaccine and he said he could not confirm or deny as she is overweight, has high blood pressure and smokes but she has never had issues before. The reason she is calling is because the tingling in the bottom jaw started within 30-45 minutes after the vaccine and she had never had that before and she is not saying it is related or not. This may help other people may be having issues and may help give information to say maybe you shouldn't smoke right after the vaccine or if you have high blood pressure or are overweight you should stay longer. For the next one her cardiologist thinks she should get the 2nd one and she will pay more attention to the signs. She has an appointment tomorrow with her cardiologist and will double check and ask him as they ask you to let them know before the vaccine if you are on a blood thinner and when her Troponin was up they have her blood thinner Warfarin through the night in the hospital and wants to double check to see if that is still in her system and if it's ok to get the 2nd dose. The physician also changed her blood pressure medication she has been on for over 15 years (No further details provided). The patient added she was hospitalized on 09Apr2021 evening and discharged 10Apr2021 around 5pm. For the investigation the patient states after the heart cath. she had an echocardiogram where you lay on your side and they do an ultrasound of your heart. The patient does not know the result of the echocardiogram, assumes it's fine but doesn't know. She took a week off at work as she was told not to bend her wrist from the procedure and has a weight restriction so she is doing her computer job. It was also reported the normal arm soreness and tired are expected but the severe, it helps to report and keep track of and it may be isolated and it may not be. The outcome of the events was unknown. The events required emergency room and physician office visit.
44 2021-04-30 pain in extremity Lemon size knot at site very red and hot to touch; Lemon size knot at site very red and hot to touch... Read more
Lemon size knot at site very red and hot to touch; Lemon size knot at site very red and hot to touch; Lemon size knot at site very red and hot to touch, bruiseing around edges hurts down arm; Lemon size knot at site very red and hot to touch, bruiseing around edges hurts down arm; This is spontaneous report from a contactable consumer (patient). A 44-year-old female patient (not pregnant at the time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 at 12:00 (Lot number: Ep7533) on the left arm as single dose for COVID-19 immunization. Medical history included allergies to Msg. There were no concomitant medications that no other medications the patient received within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 at 12:00 (Lot number: En6207) on the left arm as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 10Apr2021 at 10:00, patient experienced lemon size knot at site very red and hot to touch, bruising around edges hurts down arm. There was no treatment received for the adverse events. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
44 2021-04-30 pain in extremity 12 hours after the shot, I had pain in my arm that woke me up, I was also very tired a few hours af... Read more
12 hours after the shot, I had pain in my arm that woke me up, I was also very tired a few hours after the shot and the next day. 24 hours after the shot I developed a welt about the size a quarter on my arm, at the injection site, it was slightly raised and red. I was feeling a general malaise, and had a headache for about 2 days and developed a little bit of a cough. About 3 days after the shot, I developed mini lumps below the skin of my jaw on both sides, near the Parotid area. They felt itchy but never broke the surface, they seemed to be like a skin boil. They were about 1/4 inch round balls, and they lasted for several days. I also had a few other itchy hard spots on each arm and one on my back. I massaged the ones on my face and they went away in about a week. On April 27th I woke up with a itchy painful skin blemish on the inside of my right arm(other side of the elbow), that had broke the skin, 4 days later is is still very itchy. I was quite healthy the entire time of quarantine for the past year, after the getting the shot, I feel less healthy. I am only reporting this now, because I am scheduled to get my second dose in a few days.
44 2021-04-30 pain in extremity First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: ... Read more
First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; This is a spontaneous report from a 44-year-old female consumer (patient). A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in left arm on 07Apr2021 11:30 (Batch/Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history included asthma and allergies multiples (all antibiotics) from an unknown date and unknown if ongoing. Concomitant medications included vitamins and collagen received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced first 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. after: abdominal pain, malaise, nausea, eye puffiness, water retention on 07Apr2021 12:00. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of the events was not recovered. The events were assessed as non-serious. No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.
44 2021-04-30 cold extremities, feeling hot, discomfort passed out at work; abnormal (more than usual) vaginal bleeding; she felt uncomfortable on the morni... Read more
passed out at work; abnormal (more than usual) vaginal bleeding; she felt uncomfortable on the morning of 05Apr2021; her hands and feet were cold; she was kind of sweating; she felt sick on 05Apr2021; her body temperature went up; her body felt warm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 04Apr2021 15:45 (3:45 PM) (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. The patient medical history includes Shellfish Allergy (Reported she has had a shellfish allergy for a long time, approximately 7-8 years). She said as long as she had no shellfish, she was completely fine. There were no concomitant medications. There were no prior vaccinations (within 4 weeks). There was no additional vaccine administered on the same date as the COVID-19 Vaccine. The patient previously took bnt162b2 for COVID-19 immunization on 14Mar2021 first dose intramuscular at the left arm (Lot Number: EN6208). It was reported that the patient has received both doses of the Pfizer Covid 19 Vaccine. Her second Pfizer Covid vaccine was received on 04Apr2021. Caller started her menstrual cycle on 07Apr2021. She experienced abnormal vaginal bleeding that night. The following day on 08Apr2021 she passed out at work and was transported to the ER via ambulance. She was advised by the ER provider that her symptom was not related to the Covid 19 vaccine. However, she spoke with her OBGYN and was advised they have heard that abnormal bleeding maybe caused by the Covid 19 vaccine. The patient asked if symptom has been reported? It was further reported that she had her first COVID-19 Vaccine shot on 14Mar2021, and her second COVID-19 Vaccine dose on 04Apr2021 at 3:45 PM (PST). She clarified later in the day on 04Apr2021, the COVID-19 Vaccine kicked in. She said she felt sick on 05Apr2021. She said she felt uncomfortable on the morning of 05Apr2021, but still went to work. She said she felt OK once she got to work, but then took time off from work (on 05Apr2021) because she felt uncomfortable. She said when she got home from work (on 05Apr2021), she took 2 Tylenol. She said she was cold, and her body temperature went up, and she was kind of sweating. She clarified her hands and feet were cold, and later in the day (05Apr2021) her body temperature went up. She said she was aware of the COVID-19 side effects because some of her friends had similar symptoms, so she was kind of expecting the symptoms. She said later in the evening on 05Apr2021, she took 2 Advil and went to bed. She said her body felt warm, but she thought her symptoms were to be expected. She said on 07Apr2021, her (menstrual) period started at 10:00 PM. She said she had abnormal (more than usual) vaginal bleeding for the whole night. She said on 08Apr2021, she felt uncomfortable in the morning when she was getting ready for work. She said she went to work (on 08Apr2021), and at 1:30 PM passed out while at work. She said from her work, she was sent by ambulance to the Emergency Room. She said she was not sure if her passing out had anything to do with the COVID-19 Vaccine, but she had never passed out at work before. She said she asked the Emergency Room doctor about the COVID-19 Vaccine and her passing out. She said the Emergency Room doctor said her passing out had nothing to do with her second COVID-19 Vaccine dose. She said she read more online about the COVID-19 Vaccine. She said she then asked the nurse at her OBGYN's office about abnormal bleeding after getting the COVID-19 Vaccine. She said the nurse had heard of some cases of abnormal bleeding after getting the COVID-19 Vaccine. She said her OBGYN's nurse told her to call to find out if her abnormal bleeding had anything to do with her second COVID-19 Vaccine. She said her OBGYN's nurse provided her with the number to get more information about the COVID-19 Vaccine. It was added that while she was at the Emergency Room, she had 7 vials of blood taken, 2 ultrasounds; an external one of her tummy (abdominal ultrasound), and an internal one where something was stuck in her (transvaginal ultrasound). She said she did not know the results of her testing, and was waiting for a copy of her medical records. The patient also weighed 165 lbs on an unspecified date. It was reported that for the treatment she had taken 2 Tylenol and 2 Advil at different times while at home, but was at work, and didn't have the Tylenol or Advil to provide the dosing, NDC, Lot, and Expiration Dates. For the Emergency Room treatment she reported an EKG was done, and she was given an IV drip. She said she was not sure what IV fluids were given to her. The patient required visit to Emergency Room and stated she was taken by ambulance on 08Apr2021 and discharged from the Emergency Room at 6:00 PM the same day. The patient also visited Physician Office and stated she went for a follow-up with her OBGYN doctor at between 9:00 AM-10:00 AM on 09Apr2021. She said the Emergency Room doctor had called her OBGYN doctor on 08Apr2021, while she was in the Emergency Room. The patient underwent laboratory tests which includes: EKG, Blood Test, Abdominal Ultrasound, Transvaginal Ultrasound (All tests were performed while at the Emergency Room on 08Apr2021. Patient stated she was waiting for a copy of her medical records with the test results). The outcome of the events was recovered on Apr2021.
44 2021-05-01 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Additi... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Additional Details: Patient was slightly dizzy after vaccine, then abruptly lost consciousness, hit head on wall. She was dizzy for approx 30 minutes, BP was approx 167/88. Symptoms did not resolve after water so called paramedics to check her over. They discharged her to home. I checked with patient after 3 hours and she was feeling normal.
44 2021-05-02 breast pain Left underarm and upper chest swelling. Left breast pain.
44 2021-05-02 muscle spasms stomach cramps, back cramps lower
44 2021-05-02 pain in extremity My arm started to feel sore again after a week. ESP when lift up high. It is getting better. But was... Read more
My arm started to feel sore again after a week. ESP when lift up high. It is getting better. But was very sore a week after vaccination.
44 2021-05-03 numbness, facial paralysis Facial paralysis and numbing
44 2021-05-03 tingling, involuntary muscle movements, weakness, numbness, pain in extremity Tingling and numbness of arm of vaccine- than the other arm, dizziness, weakness, elevated heart rat... Read more
Tingling and numbness of arm of vaccine- than the other arm, dizziness, weakness, elevated heart rate, mouth trembling legs were shaky , feeling like I?m about to pass out with in 5 min. Of vaccine- later on felt tired and arm pain. Felt ok / normal then 5 days later ears were popping , head felt fuzzy, heart rate went up, felt weakness, like I?m about to faint, slight vertigo, chills, tired, weak . From that episode I started to get headaches, head was fuzzy , ears ringing slightly, felt vertigo and a lot more weakness. Had to go home from work several times as I felt I was about to pass out along with feeling the vertigo. Not feeling myself for a few weeks. Then, got my second shot on 4/26/2021. 20 min after the vaccine I had the same reaction and the first vaccine but it lasted 5 min only went home felt extremely exhausted had a head ache. Upset stomach. Super tired for the next day. I?m still not feeling 100% but I have felt a little better after 2nd vaccine. My life style has changed a bit as I am not able to do that much.
44 2021-05-03 tenderness, pain in extremity, weakness Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me d... Read more
Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me down with ice on the back of my neck and I felt better. All day felt weak and woozy and brain fog. Lethargic and spacey the following two days. Three days after the shot, I had a pain in my hand and a blood vessel started popping out and hurting. It was quite painful for that evening and night and after ice and rest and ibuprofen, swelling was down the next morning and it's still just a little tender to the touch.
44 2021-05-03 tremor, muscle twitching, numbness and pain in extremities, nerve pain, weakness, tingling, numbness The day after receiving my first dose of the vaccine, my neuropathy symptoms worsened significantly ... Read more
The day after receiving my first dose of the vaccine, my neuropathy symptoms worsened significantly from their prior state. I felt increased nerve pain, twitching, numbness/tingling, and a feeling of weakness in my arms and legs. These worsened symptoms have persisted as of the date of this submission. Additionally, 10 days after the first dose of the vaccine, I also began experiencing significant dizziness, weakness and shakiness throughout my body. I went to the ER twice for these persistent symptoms to rule out emergency conditions. The first and second ER visits were on April 23, 2021 and April 25, 2021, respectively. The testing done during my ER visits (various bloodwork, urinalysis, EKGs, CT scan of head, MRI and MRV of brain) did not find a specific cause of these symptoms. I am currently in the process of following up with a cardiologist and neurologist after my recent ER visits, so the results of some additional tests are pending. The testing done so far has not identified any other cause of these symptoms. I never had any dizziness prior to the vaccine, and my neuropathy issue has definitely worsened after the vaccine. I continue to experience the aggravated neuropathy and dizziness as of the date of this submission.
44 2021-05-04 flushing, feeling jittery, feeling hot Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: Red sun... Read more
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: Red sunburn like reaction-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: pt immediately started getting hot, skin from neck down turned red, like a sunburn. pt given benadryl, didn't seem to help. pt stated getting worse. RN gave epinephrine out of an abundance of caution. gave ibuprofen, and pt declined ice packs. Patient redness slowly resolved, but felt jittery post epipen. pt redness was nearly cleared and she felt better as she went to leave ~110pm
44 2021-05-04 numbness, flushing Pt with history of anaphylaxis to lisinopril but also reports that she is on this med for HTN. Repo... Read more
Pt with history of anaphylaxis to lisinopril but also reports that she is on this med for HTN. Reported sense of throat tightness, numbness in feet and hands Cheeks appeared flushed Given zytec 10mg Monitored for 30 minutes and felt much better
44 2021-05-04 migraine Migraine; extreme body aches; shaking chills; nausea; lower abdominal cramps; fever as high as 102; ... Read more
Migraine; extreme body aches; shaking chills; nausea; lower abdominal cramps; fever as high as 102; General malaise; when washing my hair much more than usual has come out since receiving vaccine; This is a spontaneous report from a contactable other HCP (Patient). A 44-year-old female patient received second dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection, Lot# EN5318), via an unspecified route of administration, administered in left arm on 08Feb2021 at 15:00 (at the age of 44-years) as single dose, dose 1 administered in left arm on 18Jan2021 at 02:45 (Lot# EL3246) as single dose for COVID-19 immunisation. Medical history included Lyme disease from 2017, treated with doxycycline. Patient had no known allergies. The patient concomitant medications were not reported. On 09Feb2021 at 03.00 (one day after vaccination), patient experienced migraine, extreme body aches, shaking chills, nausea, lower abdominal cramps, and fever as high as 102 lasting about 48hrs. Then lessening of symptoms over the next 12hrs and normal temp achieved by 60hrs, general malaise and when she was washing her hair much more than usual has come out since receiving vaccine. The patient underwent lab tests which included body temperature as 102 on 09Feb2021, and SARS-CoV-2 test, Nasal Swab: Negative on 09Feb2021 and pending on 12Feb2021. The patient did not receive any vaccine in four weeks nor received other medications in two weeks prior vaccination. The outcome of the events was recovering.
44 2021-05-04 pain in extremity Morning of April 03, 2021 I woke up with swollen, itchy, burning eyes and pain in hands. I took an A... Read more
Morning of April 03, 2021 I woke up with swollen, itchy, burning eyes and pain in hands. I took an Allegra and went to the vaccination center. The Head nurse sent me to the Urgent care. During the exam I developed tightness in chest and throat started to swell. Doctor determined it was a delayed analphylactic reaction to the COVID vaccine. It was delayed due to taking the Allegra the previous day. He treated me with a benedryl shot and famotidine and prednisone in pill form. Observed for 1 hour and allowed to go home. As of April 5, 2021, still experiencing tightness in chest. Swelling in face has reduced
44 2021-05-04 seizure Seizure; This is a spontaneous report from a contactable consumer. A 44-year-old female patient rece... Read more
Seizure; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The patient experienced seizure on 10Apr2021. The patient had no other vaccine in four weeks. The patient was tested for COVID post vaccination. The patient underwent lab tests and procedures which included nasal swab: negative. Therapeutic measures (medication and follow-up treatment) were taken as a result of seizure. The outcome of the event was not recovered. The event was reported as serious-hospitalized, disability, life-threatening.
44 2021-05-05 migraine 5 hours post injection - extreme fatigue; 7 hours post injection - diarrhea; 12 hours post injection... Read more
5 hours post injection - extreme fatigue; 7 hours post injection - diarrhea; 12 hours post injection - extreme body aches, chills, headache, and swollen/painful lymph node on underarm of injection site; 12 - 48 hours post injection - fatigue, body aches, and headache continued; 55 hours post injection - consistent itching sensation on lower extremities (all over legs, would not stop, had to apply cortisone cream all over both legs). I had no side effects with first injection. It's been 5 days since I received the second injection. During that time, the diarrhea and headaches have been off and on. Headache does not go away with Tylenol. I do also suffer from migraine headaches and have had to take 4 abortive migraine pills to keep the headaches manageable since receiving the injection. All of the side effects I experienced, are (from what I have read), common with the second vaccine with the exception of the itchy legs. I did not have any rash or hives develop on my legs, but they were itching so badly it was keeping me from being able to go to bed and fall asleep. I do not have allergies.
44 2021-05-05 muscle spasms Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cra... Read more
Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cramps; Hydroxyzine HCL; Amoxicillin; Acetaminophen.
44 2021-05-05 pain in extremity My lymphedema has largely been in remission. Occasionally I have symptoms for which I wear my sleeve... Read more
My lymphedema has largely been in remission. Occasionally I have symptoms for which I wear my sleeve and glove for a few hours. Following my second dose of the CV19 vaccine, my symptoms became extreme. I woke up at 3 a.m. with throbbing in my arms and armpits. I also experienced flu like symptoms for about a day.
44 2021-05-05 pain in extremity Sore arm. My blood pressure, which is usually 90s/60s started spiking along with heartrate. Nothing... Read more
Sore arm. My blood pressure, which is usually 90s/60s started spiking along with heartrate. Nothing that was dangerous, but I could feel the pressure in my legs and my head. The highest I recorded was 142/98 on 4/16. This started 4/14/21, the Wednesday after the shot and continued for about 2 weeks. By 4/28 I was back down to 90s/70s. However, I was also under a lot of job stress in that same time period and the shot might be unrelated.
44 2021-05-05 pain in extremity "The patient contacted 5/4/21 pharmacy stating her arm was still sore from 2nd Pfizer vaccine given... Read more
"The patient contacted 5/4/21 pharmacy stating her arm was still sore from 2nd Pfizer vaccine given on 4/26/21. She stated she saw NP 5/4/21 for soreness and was informed the shot was given too high in arm. We have left two messages with NP to discuss findings and she has not returned our call.
44 2021-05-05 tingling, numbness, pain in extremity Intense pain with tingling and numbness through left arm and hand immediately upon administration. I... Read more
Intense pain with tingling and numbness through left arm and hand immediately upon administration. I immediately told the administrator who informed me that happens sometimes and suggested I move my arm around. Three minutes later, I experienced a vasovagal syncope without losing consciousness and received medical attention from on-site paramedics. The paramedics monitored me and I left the event approximately 25 minutes later. The arm pain subsided after a few minutes and my blood pressure and heart rate had returned to normal about twenty minutes later. I did not receive further medical attention.
44 2021-05-06 slurring 4 days following her second COVID vaccine (4/30/21) reported headache and her coworker felt she had ... Read more
4 days following her second COVID vaccine (4/30/21) reported headache and her coworker felt she had slurred speech. She had an episode of vomiting and chills. Noted double vision the day after she was vaccinated, but that resolved prior to her headache 4/30/21. She later reported that following her first vaccine she had a headache, vertigo, and double vision. Negative lab and imaging work up. Was treated with Toradol, droperidol, Tylenol, and meclizine. Headache significantly improved after treatment. She was discharged to home.
44 2021-05-06 feeling cold, tingling "Tingling" of the head. HR fluctuating 29-80. O2 99%. Placed on 10 L Oxygen. Blanket placed on pt, c... Read more
"Tingling" of the head. HR fluctuating 29-80. O2 99%. Placed on 10 L Oxygen. Blanket placed on pt, c/o feeling cold (Temp 97.1F). At 10:30a HR down to 30, 911 called and pt sent to ER.
44 2021-05-06 feeling hot "On the drive home from work after getting vaccinated I started feeling hot and swelling up, probabl... Read more
"On the drive home from work after getting vaccinated I started feeling hot and swelling up, probably within 20 minutes of getting the vaccine. I didn't need to use my EpiPen but the hives started later that day and continued to get worse over the next few days so I went to my provider and was started on prednisone on 5/5. My symptoms have started improving (5/7).
44 2021-05-06 flushing, depressed level of consciousness, burning sensation 44 yo female with hx of pelvic congestion, s/p ovarian vein embolization on 4/12/21, no other major ... Read more
44 yo female with hx of pelvic congestion, s/p ovarian vein embolization on 4/12/21, no other major comorbidity had the second dose of Pfizer Vaccine (EW0183) 15 minutes after the patient report burning sensation whole body, associated with nausea, emesis x3, and acute shortness of breath, and decline alertness, transferred to the observation room HR 160s, O2 Sat 98%, RR: 20s, Given concern for an anaphylactic reaction * Generalized flushing And * vomiting with abdominal discomfort EpiPen was given on left thigh BP right after EpiPen was 150s/90 Oxygen 2 liters was given 911 was called The patient was transferred to MGH with all her belongings.
44 2021-05-06 pain in extremity, hot flush Arm soreness until about 15 hours post-vaccine, then chills, hot flashes, muscle/joint pain, fever, ... Read more
Arm soreness until about 15 hours post-vaccine, then chills, hot flashes, muscle/joint pain, fever, hives, extreme fatigue
44 2021-05-06 tingling I developed pain in my left arm and shoulder on 4/25. By 4/26, my arm had broken out in a spotted r... Read more
I developed pain in my left arm and shoulder on 4/25. By 4/26, my arm had broken out in a spotted red rash with clear blisters that extended into my hand. The pain was unbearable. Radiating from the top of my arm out through my fingers. My hand swelled up and I developed severe blistering on my left hand and my fingers became pins and needles numb. I could not use my arm for over a week. The rash and burning pain in my arm and hand felt like shingles. Upon my own research and speaking with the first doctor, it looked like shingles. It is now 5/7. The rash has scabbed over on my arm, but I am still in pain and the blisters remain on my hand. They are getting better, but still very severe. The pain and numbness in the tips of my fingers remains. It is hard to work or type with my left hand.
44 2021-05-07 migraine almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on ar... Read more
almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on arm it is little bit blotchy; itchy on arm it is little bit blotchy; Migraine; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 05Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient had unspecified concomitant medications; unspecified allergy medicine and unspecified vitamins. On 05Apr2021, the patient experienced the following events: almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine. Details were as follows: patient had a reaction after the vaccination. She got really dizzy, almost passed out. Then her heart started racing. It took about 10 minutes to go normal and then she got like a super dry mouth and a metal taste after that, elaborated as like she had penny or something in her mouth like metal. After that, it was little more hard to swallow and just started to get itchy on arm, it is little bit blotchy. Therapeutic measures were taken as a result of migraine, and included treatment with sumatriptan (MANUFACTURER UNKNOWN), at 100 mg ( take half every time). The outcome of events, almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine was unknown.
44 2021-05-07 pain in extremity, burning sensation, tingling Patient called into pharmacy on 05/08/2021 @ 1:15 pm stating that upon going into work this morning ... Read more
Patient called into pharmacy on 05/08/2021 @ 1:15 pm stating that upon going into work this morning around 8:00 am and starting her shift that she had weakness and tingling in the arm (left) that her injection was given. She had burning and it hurt just from the injection itself but understood that to be normal. She was concerned about the burning and tingling that was present. She also stated that it as she tried to use the arm at work ( she is a groomer ) that a weird tingling sensation traveled up to her neck and to the middle of her index finger. She had to leave work because she could not use her arm to do her job. I advised the patient to seek medical attention. I called the patient back @ 6:58 pm on 05/08/2021 and she stated that she was feeling better but has not had time to seek medical attention and was going to wait until Monday.
44 2021-05-07 pain in extremity, tingling diarrhea; digestive pain; sluggish; felt like a hangover; normal throbbing pain in my arm; tingling ... Read more
diarrhea; digestive pain; sluggish; felt like a hangover; normal throbbing pain in my arm; tingling down my arm to my fingers; throbbing pain in my arm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9269, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 04Feb2021 16:15 (at the age of 44-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and cetirizine hydrochloride (ZYRTEC) (reported as allergy medicine), both taken for unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. It was reported that 4 hours after the administration of the vaccine (04Feb2021 20:15), the patient experienced normal throbbing pain in my arm and tingling down my arm to my fingers. The next morning (05Feb2021), the patient was sluggish and felt like a hangover. From 24 hours after the administration of the vaccine (05Feb2021 16:15), the patient experienced digestive pain. The patient also experienced diarrhea on 05Feb2021 19:45. It was reported that the digestive pain started with normal bowel movements then it turned into diarrhea. The diarrhea was in different forms, from a little solid to water (this is not normal for the patient). The patient was not sure if it was the vaccine. But, the food intake was normal and the patient had not eaten any different. The patient wanted to share just in case others had experience the same thing. Therapeutic measures were taken as a result of the event diarrhea included over the counter anti-diarrhea medicine. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
44 2021-05-07 pain in extremity Prolonged arm soreness. Excessively sore for several days. Slightly sore for several weeks. Very loc... Read more
Prolonged arm soreness. Excessively sore for several days. Slightly sore for several weeks. Very localized soreness still persists as of date of reporting. Itchy rash in about .5" radius around the injection site appeared about 4 weeks after injection and persisted for 2 weeks. No treatment other than rest and drinking fluids.
44 2021-05-08 feeling hot About an hour after the vaccine, I started having a headache and rectal bleeding. Later that same ni... Read more
About an hour after the vaccine, I started having a headache and rectal bleeding. Later that same night I started feeling like I had the flu or a virus. My body felt like it was on fire with no fever, Nauseous, major head ache, fatigue. The next day I have experienced the same symptoms and am experiencing bleeding from the mouth as well. It's not severe bleeding from mouth or rectal bleeding but enough to feel it should be reported.
44 2021-05-08 numbness, tingling Elevated resting heart rate 140 bpm & elevated blood pressure. Numbness and tingling in the face 2... Read more
Elevated resting heart rate 140 bpm & elevated blood pressure. Numbness and tingling in the face 2nd shot- March 31st Loss of feel in left side extremities 13 days post vaccine.
44 2021-05-08 pain in extremity Big red welt on my arm for about a week now. Circle is very large in diameter. Arm still hurting.
44 2021-05-09 electric shock sensation, pain in extremity The person who administered the vaccine gave it to me like stabbing a knife. Immediately I left pain... Read more
The person who administered the vaccine gave it to me like stabbing a knife. Immediately I left pain that ran down my arm into my hand. It hurt and I stated so.. . the next couple of days I felt my arm was not okay...not just the pain from the shot but the movement was different and some parts of my hand are in pain. I also felt my spinal cord was affected somehow and felt shocks in the spinal cord from time to time. My arm is still not okay and when I use it a lot in the garden it is sore and seems like there is nerve or tendon damage.
44 2021-05-09 feeling cold, feeling hot, migraine Less than 24 hours after the first injection the gland in the left side of my throat was significant... Read more
Less than 24 hours after the first injection the gland in the left side of my throat was significantly swollen. This resolved at the 2 week mark. Less than 24 hours after the second injection I began to suffer migraines along with feelings of hot or cold. These symptoms are still present almost 3 weeks later.
44 2021-05-09 numbness, tingling Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: TINGLE DOWN ARM VAC... Read more
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: TINGLE DOWN ARM VACCINATED WIITHIN 15 MINUTE WAIT PERIOD WENT AWAY AFTER 25 MINUTES
44 2021-05-09 migraine Fever 101.5 for 24 hours, severe joint pain, nausea and diarrhea, migraine, cough, nose bleed
44 2021-05-09 tingling Pt. developed a reaction to 1st dose COVID-19 vaccine. Pt. has symptoms of tingling and bilater arm... Read more
Pt. developed a reaction to 1st dose COVID-19 vaccine. Pt. has symptoms of tingling and bilater arms, no nausea. Pt. has history of Ischemic stroke 9 yrs. ago. No Rx of current medication. No hospital care provided. Pt verbalizes feeling better and recovered. Pt. VS: 107/74, 80 P, 99% O2Sat, Standing BP 117/73, 86 P, 97% O2Sat.
44 2021-05-10 feeling hot I received the Biontech-Pfizer booster which is the 2nd of 2 doses. My lips felt numb for about 20 ... Read more
I received the Biontech-Pfizer booster which is the 2nd of 2 doses. My lips felt numb for about 20 min while waiting in the waiting area after receiving my 2nd dose on May, 06. 2021. The numbness went away and i could feel my lips again. Swelling of my right shoulder with soreness and swelling under my armpit with some pain began on Friday 05/07/2021 upon waking up at 8:30am. My right shoulder and armpit felt warm to touch and pain strengthen on 05/08/2021. I treated it with ibuprofen. Today 05/11/2021 the swelling is going down and the pain under my arm pit is lessening.
44 2021-05-10 grand mal seizure Within less than 36 hours after receiving the 1st dose pf the Pfizer Vaccine, I suffered a Grand Mal... Read more
Within less than 36 hours after receiving the 1st dose pf the Pfizer Vaccine, I suffered a Grand Mal Seizure . I was treated in the ER and followed up with my Neurologist. Dr. prescribed high dose of anti-seizure medication to take prior to Vaccine #2 on 5/16/2021
44 2021-05-10 numbness numbness/ Numbness on left side of the body; joint inflammation/Swollen joints; severe tiredness; Mu... Read more
numbness/ Numbness on left side of the body; joint inflammation/Swollen joints; severe tiredness; Muscle pain; Swollen lungs; This is spontaneous report from a contactable consumer via a HCP. A 44-years-old non pregnant female patient received first dose of BNT162B2 (solution for injection, Lot number: EL3301 expiry date: unknown) via an unspecified route of administration on 29DEC2020 01:30 PM, as a single dose for Covid-19 immunization at Nursing Home/Senior Living Facility. The patient Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 The patient has no history of allergies to medications, food, or other products. On 19Jan2021, the patient experienced swollen lungs. On an unknown date, she experienced numbness on left side of the body, swollen joints, muscle pain and severe tiredness. She received treatment with Medecina, for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event of swollen lungs was not recovered, while other events was unknown. No follow-up attempts were needed. No further information was expected. Lot number obtained.
44 2021-05-10 pain in extremity Same evening immunization felt hives and wheezing (4/15) which lasted through 4/17. Then on 4/18 st... Read more
Same evening immunization felt hives and wheezing (4/15) which lasted through 4/17. Then on 4/18 started to notice pain and swelling in volar surface of the ipsilateral forearm - unclear at time if it was related Was then evaluated in the office, noted to have palpable mass in volar aspect of ipsilateral forearm. duplex ultrasound showed possible mass but no clot. Follow-up ultarsound showed possbile AVM and finally MRI showed no etiology to explain the mass. repeat ultrasound described it as vascular) HIT antibody was weak positive (at 0.4) In the interim, multiple d-dimer tests were normal, but one drawn simultaneously was elevated (possible specimen issue), and there was also an transient thrombocytopenia which we understand has completely resolved. Currently, hematology + allergist referrals are pending.
44 2021-05-10 pain in extremity No adverse reactions until 13 hrs later.. From then and until present time (30hrs since shot): fever... Read more
No adverse reactions until 13 hrs later.. From then and until present time (30hrs since shot): fever 100.2-101.4 even when treated with Tylenol, three occasions of diarrhea, arm soreness and stiffness, and I have slept 13hrs out of the last 19hrs. I was forced to take the day off work and my husband has taken care of the kids and house with no help from me as I couldn?t function under these conditions.
44 2021-05-10 tingling, numbness, pain in extremity April 8th, 2021 ? 1st vaccine Sore arm April 30th, 2021 Day 1, May 1? symptoms began around 8:00 P... Read more
April 8th, 2021 ? 1st vaccine Sore arm April 30th, 2021 Day 1, May 1? symptoms began around 8:00 PM? extreme aches and chills that persisted through the night Day 2, May 2? I woke up with extreme fatigue, subtle aches. Fatigue continued throughout the day and rested Day 3, May 3? I woke up with fatigue? subsided by mid day Day 4, May 4? I woke up with extreme fatigue lasted until early evening ? I rested a good portion of this day Day 5, May 5? woke up with fatigue and felt it deep in my legs? Around 1:00 pm, I felt a tremendous amount of pressure set in on the right side of my head and numbness began on the right side of my face. I called my personal physician and spoke with her nurse. She said that I should be mindful of having stroke like symptoms and to go to the ER should they persist and increase. Around 3:15 pm by body felt tingly all over and my legs felt tingly as well. My temperature was 99.2. I had to sit down right away because the bottom of both feet felt numb and my legs began to feel numb and I knew that my heart rate was up. I felt that it was best that I go to the ER immediately. When leaving my house, I could not walk very well to the car. While driving there I could not feel my legs and the tingling in my feet was worse. I could not walk into the ER upon arrival and so I needed a wheel chair. I was seen within 10 minutes of arriving. When I go settled into my room, my body began to calm down and within 15 minutes, I could once again feel my legs and feet. The ER doctor assessed me and know unlikely based on my current state, he wanted to be sure that I wasn?t having a stroke or anything else and so he ordered a CT Scan which came back clear and then he ordered an MRI which also came back clear. It was explained to me that my body had gone into a fight or flight response, described as an anxiety attack and that the reason was unknown. I did not feel anxious prior to the initial symptoms of the tingling and numbness over my body, however once I felt these symptoms, I actually thought I might be having a stroke which likely triggered an anxious response. It was shared and with caution, that I could have been having some kind of immune response to the vaccine, but there was no way of knowing this. I was released from the hospital with no further issues Day 6, May 6? I woke up feeling much better and was able to carry on with my normal tasks that day Day 7, May 7? I woke up with deep fatigue combined with head pressure that progressed morning into the mid day along with numbness on the right side of my face. I called my doctor that morning to report my symptoms and received a phone call shortly thereafter from the same nurse I had spoken with on Day 5. I told her I felt ok overall and she told me to be mindful of my symptoms over the weekend but suggested I report to VAERS. Day 8, May 8? I was able to carry on with normal tasks Day 9, May 9? I was able to carry on with normal tasks Day 10, May 10? I woke up with fatigue again that subsided mid day. Day 11, May 11? I woke up with minimal fatigue Noted: I have had an increased heart rate intermittently over the past several days.
44 2021-05-10 tingling pt. c/o - tingling of right leg; itching of her throat. symptoms resolved and pt. went home
44 2021-05-11 flushing Angioedema with throat tightness, flushed and near syncope
44 2021-05-11 migraine Extremely intense migraine attack that hasn't decreased since the vaccine was applied (12 days so fa... Read more
Extremely intense migraine attack that hasn't decreased since the vaccine was applied (12 days so far)
44 2021-05-11 speech disorder chest heaviness/very strong heaviness in her chest; restricted breathing; more breathless with any a... Read more
chest heaviness/very strong heaviness in her chest; restricted breathing; more breathless with any activity; breathing was difficult; difficult for his wife to talk and walk (because of her breathing).; difficult for his wife to talk and walk (because of her breathing).; allergic reaction; This is a spontaneous report from a contactable consumer (patient's husband) A 44 year old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ), intramuscular, administered in Arm Left on 21Apr2021 at 13:30 (at the age of 44 years old)(Batch/Lot Number: EW0162; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation. Historical Vaccine includes Dose 1 on 23Mar2021 administered left arm, Lot Number: ER8727 and Expiration Date: 01Jul2021 for covid-19 immunisation ('had no problem'). The patient medical history was not reported. Concomitant medication(s) included phenylephrine hcl (PHENYLEPHRINE HCL) CVS brand NDC Number: 59779-094-68, Lot Number: 0EE3081 Expiry: Jan2022, taken for nasal decongestion therapy from Apr2021 and ongoing.No Additional Vaccines were Administered on Same Date of the Pfizer Suspect. On 22Apr2021, The patient experienced chest heaviness/very strong heaviness in her chest, restricted breathing, allergic reaction, difficult for his wife to talk and walk, more breathless with any activity, breathing was difficult. The patient underwent lab tests and procedures which included electrocardiogram normal: results normal on 24Apr2021. Therapeutic measures were taken as a result of chest heaviness/very strong heaviness in her chest, restricted breathing. The clinical course was reported as follows Husband Reported on behalf of his wife got her first COVID-19 Vaccine dose 1, and had no problem, and was fine. He said when his wife got her second COVID-19 Vaccine dose on Tuesday, 21Apr2021, the first day she was fine, but towards the second day (22Apr2021), she had a very strong heaviness in her chest, and her breathing was restricted. His wife thought she may be having a severe allergic reaction to the COVID-19 Vaccine. Reporter made a few calls to the doctor, and the doctor told him to continue to monitor his wife, and maybe in a day, or 2, her symptoms would go away. On Saturday, 24Apr2021, his wife still had the chest heaviness, and it was very difficult for his wife to talk and walk (because of her breathing). On Saturday, 24Apr2021, the patient went to an urgent care. The doctor (clarified as a PA-physician assistant) looked for other symptoms his wife might have, and told his wife she did not have the COVID-19 Virus. He said his wife was told there were reports that the Pfizer COVID-19 vaccine was known for thickening the blood and for causing inflammation of the heart, said that she had an allergic reaction so an EKG was done at the time, and the EKG was normal. The PA (physician assistant) prescribed Ibuprofen 600mg (Lot Number: DE2607, Expiration Date Feb2022) by mouth daily. Also reported as (' 3 Ibuprofen 200mg tablets a day (600mg total),', and told his wife to return in 3 days if her symptoms were not better. It was also Reported his wife's chest heaviness had gone away, but the came back. Chest heaviness was not worse, but it had not gone away. The caller stated the doctor (PA) concluded that the Pfizer COVID-19 Vaccine produced too many antibodies in his wife, and the antibodies made his wife's blood thick. He said the doctor (PA) prescribed the Ibuprofen to help with his wife's blood flow. Subsequently the patient's husband had called Pfizer to report his wife's experience, but to also to find out how long his wife needed to continue taking the Ibuprofen. Reporter's wife, entered the call. She said the doctor (PA) suggested the Ibuprofen for inflammation. She stated she was more breathless with any activity (if she spoke or moved around). She said if she sat still, her breathing was fine. She said she was not physically tired at all, but her breathing was difficult. She said her chest heaviness was OK yesterday (25Apr2021), but when she woke up this morning, she had the chest heaviness again. She said her chest heaviness was better, but persisting. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected
44 2021-05-11 tremor pt received 1st pfizer covid shot at 3:47 pm. she told me she had a history of anaphylaxis to oral b... Read more
pt received 1st pfizer covid shot at 3:47 pm. she told me she had a history of anaphylaxis to oral benadryl and i counseled her that she should wait 30 minutes for observation after the immunization. around 4 pm she notified my technician the outside of her throat was starting to feel hot and itchy. i took her into the room and sat her down in private. I gave her an ice pack to put on her throat and was observing her when the itching started on her abdomen. I advised her she was having an anaphylactic event and she denied me calling ambulance or using epipen. Around 4:05 pm she asked for some cream so we gave her some hydrocortisone cream OTC that she applied to itchy area on chest and throat and she said she was feeling better. Around 4:15 she told me the itching was starting inside her mouth and allowed me to call 911 and administer one dose of epinephrine 0.3 mg in her left thigh. The fire department came around 4:20 and started talking to her and taking vitals. blood pressure was 146/90 and heart rate was 100 even with the epinephrine causing her to shake. They advised she wait for emt's that arrived around 4:30 pm and they conviced her to go in the ambulence to the hospital even though she was feeling fine since there was a chance the epi would wear off and she would need more help.
44 2021-05-12 weakness Immediate exhaustion Insane food cravings ( I never crave anything); followed by unprecedented blood... Read more
Immediate exhaustion Insane food cravings ( I never crave anything); followed by unprecedented blood loss. Its been so many days that I am weak and tired. I am horrified by the long term, so much so that I refuse to get the second dose scheduled for today. This should NOT do this to the female body! You should all be ashamed. Eight women I know have the same experience.
44 2021-05-12 breast pain May 7, 2021, approximately 9 hours after receiving the vaccine, I experienced nausea, vomited and di... Read more
May 7, 2021, approximately 9 hours after receiving the vaccine, I experienced nausea, vomited and diarrhea. After 13 hours after receiving the second dose of the vaccine, my leg muscles began to contract uncontrollably, which caused severe pain. The contractions did not stop for two hours, after taking three Aleve tablets. This was followed by extreme fatigue for an additional 24-hour period alongside bruising down my legs and signs of popped blood vessels. An additional symptom that I continue to experience is massive swelling and pain in my breasts – this has lasted for three days. I was sent to the ER to determine if I had a blood clot in my leg.
44 2021-05-12 cold sweat Pt fainted in 15 minute waiting area falling on her face & hitting L/cheek & chin. Per w/c taken to ... Read more
Pt fainted in 15 minute waiting area falling on her face & hitting L/cheek & chin. Per w/c taken to Observation area with cold compress to face. BP 95/85 P 55. 5:50PM Sitting up BP 96/67 P 59 clammy 6:11pm BP 109/71 P 58. Feeling much better. Left w/o assistance.
44 2021-05-12 facial pain, facial paralysis, nerve pain, bell's palsy four days later I got very tired, sore throat, swollen face, pain on the left side of neck and face ... Read more
four days later I got very tired, sore throat, swollen face, pain on the left side of neck and face (which is already chronic for me, but this was more acute), and nerve pain across my left cheek under the sinus, right side of my face drooping (bells palsy)
44 2021-05-12 flushing Sore and swollen gums, dizziness, fatigue, red and flushed face
44 2021-05-12 hot flush, night sweats Chills, fever, exhaustion, nausea, headache Delay in period (no period since the vaccine), over a ... Read more
Chills, fever, exhaustion, nausea, headache Delay in period (no period since the vaccine), over a week late. Hot flashes and sweat night appears for over a week (2 weeks after the vaccine). I was regular before the vaccine and never experienced hot flashes before.
44 2021-05-12 migraine migraine
44 2021-05-12 pain in extremity, weakness Arm started sore then after a few hours felt drained. By 6:30 pm had head ache and muscle aches to... Read more
Arm started sore then after a few hours felt drained. By 6:30 pm had head ache and muscle aches took hot shower then went to sleep. Sleep for about 14 hours then. Still feel pain in my arm and muscles but also now have low grade fever even after taking tylenole at 10:15 am at 12:20 pm 99.9 degrees also have headache
44 2021-05-12 tingling, hot flush 20 minuted after getting my second dose I started having an anaphylaxis reaction. My throat became i... Read more
20 minuted after getting my second dose I started having an anaphylaxis reaction. My throat became itchy, sore and started to feel tight. I took 3 doses of benadryl to help calm the symptoms as I did not want to get stuck paying for an emergency room visit or use my EpiPen which would also result in an ER visit. Soon after, I also started feeling extremely itchy all over but mainly at injection site. My body became tingly and I had hot and cold flashes. About an hour after that, the headache, nausea and horrible body aches began. the itching at injection site stopped after 2 hours but the rest of the symptoms remained for 3 days with the exception of the headache, nausea and body aches which still remain and no amount of over the counter medication help.
44 2021-05-12 tingling, numbness, pain in extremity Numbness and tingling in my fingers on left hand, Left arm feeling very heavy and sore
44 2021-05-12 tingling, pain in extremity L arm pain and parasthesias after noting LAD in L axillar.
44 2021-05-13 inability to speak, speech disorder, tingling, numbness Neurological / Cognitive side effects: trouble forming sentences, word loss, short term memory loss,... Read more
Neurological / Cognitive side effects: trouble forming sentences, word loss, short term memory loss, typing issues, slowed hand / eye coordination, numbness and tingling in left hand, wrist and foot (injection side) - could not feel the bottom of my foot for the first 2 days, gait affected. Side effects began to lessen on day 5, but still dealing with some slight speech issues and short term memory loss.
44 2021-05-13 difficulty speaking Following the first dose of the Pfizer vaccine, the patient reported to our medical tent with compla... Read more
Following the first dose of the Pfizer vaccine, the patient reported to our medical tent with complaints of nausea and stomach discomfort. During assessment, she developed new complaints of throat itching, tongue and facial swelling, and voice changes. The provider onsite administered diphenhydramine 25mg IM at 1340, epi 0.3mg IM at 1343 with some resolution of symptoms. Patient reported symptoms again at 1348 so an additional epi 0.3mg IM and diphenhydramine 25mg IM given. EMS onsite at 1350 and patient was transported to local emergency room. ED room notes describe the following: BP=123/84, HR=75, Temp=36.8, RR=19, O2Sat=98%, EKG normal, Troponin <0.02. Notes are limited. Patient reported ongoing throat swelling. RN noted that oral cavity visualized with no swelling observed. HR up to 125 with patient complaints of heart 'racing,' reassurance provided. Patient discharged to home following several hours of observation and a primary diagnosis of 'allergic reaction.'
44 2021-05-13 pain in extremity Shot was given in the joint of the shoulder not the deltoid muscle. Normally needle sticks don't hu... Read more
Shot was given in the joint of the shoulder not the deltoid muscle. Normally needle sticks don't hurt me, this one was painful like the ones I had to get in my ankles and feet. By 8pm Pain migrated down to the muscle and was excruciating for days. Went from being able to do normal movements of the arm during the day to no movement at all by night. No OTC pain meds helped nor did heat or ice. Was woken up in the night by pain being even worse(did not sleep on arm). After 2 days pain finally lessened with otc?s but comes back as soon as arm is in bent position with elbow to side or is raised to 90° or higher in any position Pain is down in muscles about 3 inches below injection site.
44 2021-05-13 tingling, muscle twitching, feeling cold Ice cold in veins immediately after the shot. The next day: fatigue, head pressure/cold. Strange hea... Read more
Ice cold in veins immediately after the shot. The next day: fatigue, head pressure/cold. Strange heartbeat. 2 days later: muscle twitching (all over body), tingling in feet and palms. Tingling in palms resolved after a few days, but persisting on the bottom of a right foot 10 days after the injection (on the day of the reporting).
44 2021-05-14 bell's palsy Bell's Palsy; The patient was pregnant at the time of vaccination/Delivery date would be on 06Jun202... Read more
Bell's Palsy; The patient was pregnant at the time of vaccination/Delivery date would be on 06Jun2021; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in right arm, on 24Mar2021 (Lot Number: ER8132, at the age of 44-year-old) as single dose, for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 03Mar2021 (Lot Number: EN6199, at the age of 44-year-old) as single dose for covid-19 immunization and experienced pregnant at the time of vaccination. The patient was pregnant at the time of vaccination. Gestation period was 30. Delivery date would be on 06Jun2021. The patient experienced bell's palsy on 08May2021. Patient visited doctor or other healthcare professional office/clinic, emergency room/department or urgent care due to the event. Treatment included steroid prescription. Patient did not have Covid prior vaccination and did not have Covid tested post vaccination. Patient had no other vaccine in four weeks. The outcome of the event Bell's Palsy was recovering.
44 2021-05-14 feeling cold blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right... Read more
blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right; Head felt weird; Felt Cold; lightheaded; This is a spontaneous report from a contactable consumer reporting for herself. A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 22Apr2021 at 11:30 (Batch/Lot Number: EW0171) as a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date and no vaccination administered in the 4 weeks prior. Medical history included ongoing Hashimoto's Thyroid (diagnosed with this condition many, many years ago). There was no relevant family history. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 01Apr2021, Lot Number: ER8737; in right arm. On 22Apr2021, about a half hour after the shot she states her head felt weird, she couldn't swallow, she felt cold, and she could not breathe right. On 23Apr2021, she was driving her husband and blacked out. Her tongue also began to swell. She just happened to be by the exit ramp to the hospital. She visited the Emergency Room. They told her she was having a delayed anaphylactic reaction. No relevant tests were performed according to the reporter. All of her symptoms recovered when she started prednisone on 23Apr2021. She was prescribed prednisone, taper dose with last dose 27Apr2021. She still remained with lightheadedness and still could not drive. The only one persisting was the weird feeling in her head, almost like a lightheaded feeling. She could not drive due to this symptom There was no physician office visit for the events. The events delayed anaphylactic reaction, blacked out, tongue swelled, couldn't swallow, couldn't breathe right, and feeling cold were resolved on 23Apr2021. The lightheadedness and head felt weird were ongoing (not recovered).
44 2021-05-15 electric shock sensation Fever of 101 degrees, nausea, and skin felt hypersensitive to touch for about 48 hours. Ongoing symp... Read more
Fever of 101 degrees, nausea, and skin felt hypersensitive to touch for about 48 hours. Ongoing symptom of intermittent sensations in arms and face that feels like quick "zings" of electricity. This happens usually when I am exercising or make fast movements. It seems to be improving over the weeks since I got the vaccine and is not impacting daily activities too much at the point.
44 2021-05-15 tingling Swelling and redness, in face and neck, hands/wrists, feet - Mild (but severe enough to be noticeabl... Read more
Swelling and redness, in face and neck, hands/wrists, feet - Mild (but severe enough to be noticeable to others); 1st dose occurred 2-3 hours later, was mostly gone by next morning; 2nd does occurred in about 30 minutes; even more mild, but still noticeable, Zyrtec allergy pill lessened it to very mild swelling Swelling in mouth (left lower lip and left side of tongue) only at 2nd dose; the Zyrtec did help, but it did not go away Slight tingling in hands, mostly fingertips - 2nd dose only; mild Extreme fatigue, headache, nausea - 1st dose only, lasted two days
44 2021-05-16 speech disorder, numbness, weakness On the afternoon of 2/5/21 I developed dizziness, right hand numbness/weakness, difficulty speaking ... Read more
On the afternoon of 2/5/21 I developed dizziness, right hand numbness/weakness, difficulty speaking while at work. On 2/7/21 and 2/8/21 I noticed difficulty in writing so I called my PCP who ordered a brain/spine MRI for 2/12/21 which showed a right cerebellar subacute infarction, occupational therapy for right hand weakness/writing deficits, mostly resolved (~95% resolved)
44 2021-05-17 pain in extremity Right jaw and lower teeth hurt for 3 days; Right jaw and lower teeth hurt for 3 days; chills; sore a... Read more
Right jaw and lower teeth hurt for 3 days; Right jaw and lower teeth hurt for 3 days; chills; sore arm; This is a spontaneous report from a contactable Other Health Professional (Patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 44 years of age), via intramuscular administered in Arm Left on 13Jan2021 19:30 (Batch/Lot Number: EK9231) as Unknown, single for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not have any other vaccine within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, has the patient been tested for COVID-19 test. The patient's concomitant medications were not reported. The patient experienced right jaw and lower teeth hurt for 3 days, chills and sore arm on 14Jan2021 03:00. The patient underwent lab tests and procedures which included smear test: negative, on 19Jun2020 Covid test. The seriousness criteria of the events were reported as non-serious by the health authority. No treatment and or medical procedure was performed for all events. The outcome of the events were right jaw and lower teeth hurt for 3 days recovered on 17Jan2021, chills and sore arm recovered on an unspecified date. Follow-up attempts are completed. No further information is expected. .
44 2021-05-17 pain in extremity Arm pain; tiredness; body aches; flu; chills; This is a spontaneous report from a contactable consum... Read more
Arm pain; tiredness; body aches; flu; chills; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 31Jan2021 at 10:45 AM, single dose for COVID-19 immunisation. The patient's medical history included Clindymycin sulfas allergy and she was diagnosed with COVID-19 Prior to vaccination. The concomitant medication was not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not disclose other medications which she received within 2 weeks of vaccination. The patient experienced Arm pain, tiredness, body aches, feel like I have the flu, chills on 31Jan2021. She did not receive any treatment for adverse event. The outcome of events was reported as unknown. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
44 2021-05-17 pain in extremity Had fever of 102 about 5 hr after 2nd shot, headache, nausea, arm soreness. Lasted 4 days. Did not r... Read more
Had fever of 102 about 5 hr after 2nd shot, headache, nausea, arm soreness. Lasted 4 days. Did not report to anyone cause I heard it may happen. I just had a slight fever and arm soreness for the first shot.
44 2021-05-18 bell's palsy developed Bell's Palsy on the right side of my face; This is a spontaneous report from a contactable... Read more
developed Bell's Palsy on the right side of my face; This is a spontaneous report from a contactable consumer (patient) This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: EW0164), dose 1, via an unspecified route of administration in the left arm on 16Apr2021 at 14:00 (at the age of 44-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included seizure from an unknown date and unknown if ongoing (Seizure disorder-7 years no seizure, 5 years no medication) and penicillin allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin [erythromycin estolate] and experienced hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 14:00, the patient developed Bell's palsy on the right said of her face. The event resulted in an emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab) (03May2021): pending results. Therapeutic measures taken included unspecified steroids and unspecified anti-viral medications. Clinical outcome of the event developed Bell's palsy was not resolved.
44 2021-05-18 involuntary muscle movements, cold sweat Patient had received her 2nd COVID vaccine and was about 10 minutes into her post vaccination waitin... Read more
Patient had received her 2nd COVID vaccine and was about 10 minutes into her post vaccination waiting when she began feeling lightheaded, clammy, and nauseated. She got up and walked over to the staff desk where she continued to feel lightheaded and developed tunnel vision. Staff got her into a wheelchair and she subsequently lost consciousness. They noticed brief arm and leg jerking motions. She had no bowel or bladder incontinence or tongue bite. There was no postictal period. She is brought to the ED. She has had minimal to eat or drink today. She does note that she has had multiple syncopal episodes in the past including with blood draws and at the dentist. She currently feels fatigued and slightly nauseated. She was lightheaded and had difficulty standing after the episode so she was brought to the ED The episode sounds more consistent with syncope than seizure given the lack of postictal period, no tongue bite, bowel or bladder incontinence. She likely had some myoclonic jerks due to syncope in an upright position. EKG shows normal sinus rhythm without evidence acute ischemia or infarct, low suspicion for ACS or malignant dysrhythmia as cause for syncope, particularly since she had a clear prodrome prior to syncope. Symptoms appear most consistent with vasovagal syncope related to vaccination. Patient feeling improved after rest and p.o. intake. Able to ambulate steadily in ED. Appears appropriate for outpatient follow-up.
44 2021-05-18 hot flush, pain in extremity Approximately 5 minutes post second vaccination: Hot flashes, sweating, blurry / dark vision, ear r... Read more
Approximately 5 minutes post second vaccination: Hot flashes, sweating, blurry / dark vision, ear ringing / loss of hearing, loss of color in face, slumped to the floor near fainting. That night: Extreme arm pain. Could not sleep. Next morning: Arm and armpit pain, neck, jaw / TMJ pain, myofacial pain, headache, fatigue, right hip / joint pain (still present 7 days later and never had this issue before).
44 2021-05-18 numbness, tingling Numbness and pins and needles affecting right leg and also hands. Still happening 4 days later
44 2021-05-18 numbness After shot got dizzy had sortness of breath tightness in chest throat tight and numbness and tinglin... Read more
After shot got dizzy had sortness of breath tightness in chest throat tight and numbness and tingling in lower lip..at onset of symptoms took benedryl and after about one hour symptoms started to alleviate
44 2021-05-18 nerve pain, pain in extremity discomfort pain at the injection site; can't eat; Nerve pain; arm pain; Abdominal pain; feelings of ... Read more
discomfort pain at the injection site; can't eat; Nerve pain; arm pain; Abdominal pain; feelings of fullness; Food intolerance; Heartburn; Indigestion; Pancreatitis/my auto immune flares as pancreatitis; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 (Batch/Lot Number: ER8731) at the age of 44 years, as single dose for covid-19 immunisation. Medical history included systemic lupus erythematosus from 1994 and ongoing, hypothyroidism from an unknown date and unknown if ongoing, Addison's disease from an unknown date and unknown if ongoing , autoimmune pancreatitis from 2015 and ongoing. The patient's concomitant medications were not reported. The patient experienced pancreatitis/my auto immune flares as pancreatitis on 24Apr2021 after 10 days from vaccination. On an unspecified date the patient experienced discomfort pain at the injection site, can't eat, nerve pain, arm pain, abdominal pain, feelings of fullness, food intolerance, heartburn, indigestion. The patient didn't think her immune response will be as strong. She has lupus, her auto immune flares as pancreatitis. This is one of the most significant flares that she has experienced. The flare is very significant and she is suffering. This is a direct result from the vaccine. Even though she has lupus she is in exceptional health. Her physicians consulted came to the consensus that it getting the vaccine benefit outweighs the risk and chose the pfizer covid vaccine. They knew she may experience a flare, wasn't something uncommon, there was knowledge a flare may happen but nothing so intense. She can't eat. She can only have water and medication. She is going to see what blood results are in. The patient underwent lab tests and procedures which included blood test: unknown results on unknown date. The outcome of the events was unknown.
44 2021-05-19 migraine feverish, achey, diarrhea, headache for 10 days culminating in migraine (vomiting/diarrhea)
44 2021-05-19 muscle spasms Right as injection was going in I felt a rush of something up my arm, side of my neck and into my ea... Read more
Right as injection was going in I felt a rush of something up my arm, side of my neck and into my ear. Waited 15 minutes and I felt okay. But then I started having really weird symptoms had horrible, horrible cramps. I haven't had cramps in years (decades). It turned into every gland in my neck or body were inflamed and sore and I couldn't move. I was so sick. I went to my doctor and he could tell my glands were swollen on the left side they hurt but on the right side they didn't hurt but they were inflamed. I missed a week of work and I was so tired. So lethargic. Was just told that if my symptoms worsened to go to ER. I did Tylenol, Ibuprofen and vitamins and I had to use a heating pad. I'm still at this time pretty tired all the time.
44 2021-05-19 pain in extremity pt says she had a hot red swollen right leg that was very painful. On 4/16/21 she went to the Hospi... Read more
pt says she had a hot red swollen right leg that was very painful. On 4/16/21 she went to the Hospital ER. She had blood test and was given an US of the right leg where they found 2 blood clots. She was started on blood thinner. She was discharged and told to FU w/ PCP. On 4/21/21 she saw the doctor. She increased the blood thinner because she found a abdominal hematoma this size of two grapefruits. On 4/25/21 she was having trouble breathing and her leg was red and inflamed. She went back to the Hospital ER they thought she was having a pulmonary embolism. They did more blood work and chest x-ray. She was given Lovenox shots and took her off the blood thinner. She was discharged to go home and give herself these shots. On 4/27/21 she had a reaction to the Lovenox shot so she called her PCP. She saw the doctor on 4/29/21 she was told to continue using the Lovenox. She went back to Dr. on 5/4/21 and she was taken off Lovenox and put back on blood thinner Eliquis with doubled dosage. She was monitored. On 5/8/21 both of her legs were red and swollen and she went to her Doctors office. They did a blood test and was sent home. On 5/10/21 she went back to her PCP. Dr. office where she was sent to Hospital ER for direct admit. They did another US and a CT. They found she had blood clots in both legs. She was given IV fluids, antibiotics, was given heparin and taken off Eliquis. On 5/13/21 she was given warfarin along w/ heparin. She was discharged on 5/16/21. She still has pain and redness in both feet and legs and has been diagnosed w/ Cellulitis. She is now taking Oxycodone and Coumadin. She will see her PCP on 5/21/21.
44 2021-05-19 pain in extremity suddenly developed nystagmus; arm was sore for 2 days; This is a spontaneous report received from a ... Read more
suddenly developed nystagmus; arm was sore for 2 days; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 44-years-old), administered in Arm Left on 17Apr2021 12:15 (Lot Number: ER8731) as 1st dose, single for COVID-19 immunization. Medical history included Penicillin allergy, Mango skin allergies, poison ivy allergies, and very spotty history of migraine with visual phenomena fewer than 10 episodes my whole life. The patient was not pregnant. Concomitant medication included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN) taken for an unspecified indication, start and stop date were not reported. The patient stated, "After the vaccine (17Apr2021), my arm was sore for 2 days, no other effects. A week later, I was lying on my right side and suddenly developed nystagmus on 24Apr2021 11:00 AM. It subsided in a few minutes but has continued every morning after I wake up, clearly a result of lying on my right side. No other triggers: I am able to function normally (driving, biking, reading, computer use), but it has not subsided. I have a doctor's appointment scheduled next week." No treatment received for events. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of arm was sore for 2 days was recovered on 19Apr2021 while for nystagmus was not recovered. The events were reported as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
44 2021-05-20 night sweats Intense nausea, fever, night sweats, entire body chills, joint aches, muscle pain, intense headache ... Read more
Intense nausea, fever, night sweats, entire body chills, joint aches, muscle pain, intense headache in sinus areas of head and face, extreme fatigue.
44 2021-05-20 tingling, nerve pain On May 13, 2021, approximately 4 weeks after second dose of the vaccine, I developed a very severe s... Read more
On May 13, 2021, approximately 4 weeks after second dose of the vaccine, I developed a very severe stabbing ice pick headache on the left side of my head behind my eye. By May 17, 2021, the pain was so severe that I went to the emergency room but did not receive a clear diagnosis. On May 18, 2021, I began to notice a prickly sensation on my forehead and rash forming. Urgent care confirmed diagnosis of shingles on evening of May 18, I was prescribed Valtrex, Gabapentin, and an oral steroid. As of today (May 21), the shingles rash is blistering on my left forehead, eyelid, and scalp and is mildly painful, and I have a few swollen lymph nodes, but the shooting nerve headache comes back intermittently and is still very uncomfortable. I feel that this should be reported because if people could be more susceptible to shingles after the vaccine, there should be public information about this. My case was very scary with the terrible shooting nerve pain in my head and I have learned that it is very important to get treatment for shingles started as early as possible to prevent long term effects, so I think this is something people should be made aware of.
44 2021-05-21 facial paralysis When I received the vaccine I felt very tired but after a few days I had facial paralysis, the next ... Read more
When I received the vaccine I felt very tired but after a few days I had facial paralysis, the next day I went to the emergency since I felt so bad.
44 2021-05-21 pain in extremity Sore arm, low grade fever, exhaustion - initially - persistent, pressure headache that has lasted t... Read more
Sore arm, low grade fever, exhaustion - initially - persistent, pressure headache that has lasted two days.
44 2021-05-21 tingling heaviness of tongue, tingling lips, tingling toes
44 2021-05-22 feeling hot I felt fine after receiving the vaccine and was waiting my 20 minutes before leaving. At 15 minutes... Read more
I felt fine after receiving the vaccine and was waiting my 20 minutes before leaving. At 15 minutes I felt a strange feeling in my chest. I would describe it as a warm tightness, primarily on the left side. Just as I was about to notify someone at the vaccine site, it went away. It only lasted a few minutes. The exact same thing happened on my second vaccine on 3/26/21 Pfizer ER8727 at the same Pharmacy location. I was standing at the front door of the Pharmacy waiting for my last 5 minutes to leave when the same thing happened. I went back to the pharmacy and sat in a chair right in front of the pharmacy so someone could see me if something happened. The feeling lasted a couple minutes in my chest and then I felt fine again. I pulled up the site to report the info, but never took the time to do it until now.
44 2021-05-22 throat numbness, numbness neck and throat numbness
44 2021-05-22 speech disorder Patient stated she felt highly inebriated. She said it took all of her concentration to talk clearl... Read more
Patient stated she felt highly inebriated. She said it took all of her concentration to talk clearly. The onset was approximately one and one-half hours post administration. She had no swelling of tongue, face, or throat. No problems with breathing or airway constriction. Patient had not eaten all day before the immunization even at the time we spoke on the phone. I asked her to go to the emergency room. She wanted to delay. I called her back 45 minutes later. The patient had eaten and had a beverage. She said all symptoms had gone away except she felt a bit tired. I discouraged her from receiving the next dose.
44 2021-05-23 nerve pain Period (Menstration) is 2 weeks late (this is very unusual for me). Did not receive 2nd dose yet due... Read more
Period (Menstration) is 2 weeks late (this is very unusual for me). Did not receive 2nd dose yet due to ongoing inflamation and increased leg nerve pain. Loss of taste and smell seems to have increased since vaccine (although started with Covid in Nov2020)
44 2021-05-23 paralysis Are swelling and paralysis, fever, disorientation, headaches,
44 2021-05-24 weakness mid sternal non-radiating chest pain, generalized weakness, elevated Troponin, Left heart catheteriz... Read more
mid sternal non-radiating chest pain, generalized weakness, elevated Troponin, Left heart catheterization
44 2021-05-24 difficulty speaking 11:40- pt asked if her hands and face should be itching 11:41- gave Benadryl 50 mg PO and checked O2... Read more
11:40- pt asked if her hands and face should be itching 11:41- gave Benadryl 50 mg PO and checked O2 she was at 96% on room air 11:45- pt started saying her throat felt tight O2 92% face was red and could see signs of distress so she was given an EpiPen, ambulance was called 11:50- did vitals BP 140/78, HR 103, O2 93% pt stated she felt like she was going to pass out and it was still hard to breath 11:55- pt still struggling to breath O2 92% voice muffled, face visible red, signs of distress 2nd EpiPen given 12:03- ambulance arrived pt never lost consciousness
44 2021-05-24 flushing, pain in extremity Initial shot: nausea, extreme fatigue for 5 days. Second shot: immediate arm pain, warm. In the ... Read more
Initial shot: nausea, extreme fatigue for 5 days. Second shot: immediate arm pain, warm. In the first day lightheaded, limbs heavy feeling, unfocused, flushed, fatigue, hives for about an hour. Next day headache, lightheaded, neck tightness, fatigue, lymph node pain, arm pain, nausea. Next day nausea, arm pain, stomach pain, fatigue. Next day nausea and fatigue. Nausea lasted 5 days.
44 2021-05-24 tremor 5 minutes post vaccination (1053) pt began experiencing dizziness, tremors & nausea. BP 99/71, P 74... Read more
5 minutes post vaccination (1053) pt began experiencing dizziness, tremors & nausea. BP 99/71, P 74, SAO2 93%. O2 started. Pt began retching white foam at 1059. EpiPen 0.3 ml given to right thigh but due to incorrect administration had to be readministered. 911 called. At 1103 pulse was 81. EMS arrived at 1104. At 1106, pulse was 67 & O2 was 99%. Patient was transported to ER at 1113. EMS gave Benadryl & Solumedrol during transfer. ER notes at arrival pt was AAO x4, tremors noted [per pt, worse than baseline], pt constantly clearing throat. Vitals on admission to ER: BP 106/55, pulse 88, RR 20, pulse ox 99%. Hx noted no prior reaction to any immunization. ER treatment: additional Benadryl 25 mg IV x1 given. Motrin 800 mg po x1 given for headache. Patient observed and discharged with prescriptions for Benadryl 25 mg caps and Medrol dospak at 1257. Per discharge notes, stable and sx resolved. Patient was counseled to not take the 2nd dose
44 2021-05-25 pain in extremity, breast pain I have had terrible underarm and breast pain including nipple pain on my left breast since by second... Read more
I have had terrible underarm and breast pain including nipple pain on my left breast since by second vaccine. It feels worse than after giving birth.
44 2021-05-26 numbness Numbing in mouth jaw & gum, breathing wheezing problems, shortness of breath, irritations, skin & t... Read more
Numbing in mouth jaw & gum, breathing wheezing problems, shortness of breath, irritations, skin & tongue burning, messed up my monthly period, swollen eyes, swollen lymph nodes, swollen face & mouth..heart achs & discomfort.
44 2021-05-26 pain in extremity flu symptoms, chills, fever for 5 days, shallow breathing, left arm pain & swelling for 3 weeks pel... Read more
flu symptoms, chills, fever for 5 days, shallow breathing, left arm pain & swelling for 3 weeks pelvic pain, heart pain, red bumps on body
44 2021-05-26 seizure Patient had 2 seizures about 5 minutes after receiving her first Covid vaccine. Spouse was with her... Read more
Patient had 2 seizures about 5 minutes after receiving her first Covid vaccine. Spouse was with her and did not think seizure was due to vaccine, but that she has a history of seizures if over anxious or becoming overheated. They did not want me to call 911 and seizures resolved.
44 2021-05-27 weakness, numbness, tingling flare of GB symptoms including lower extremity weakness, numbness, and tingling.
44 2021-05-27 flushing, cold sweat, difficulty speaking Flushing, clammy skin, coughing, wheezing, dyspnea, voice changes, patient stated she felt like - "I... Read more
Flushing, clammy skin, coughing, wheezing, dyspnea, voice changes, patient stated she felt like - "I can breathe in but I can't breathe out"
44 2021-05-27 flushing shortly after receiving the vaccine, she developed lightheadedness, frontal headache and a feeling o... Read more
shortly after receiving the vaccine, she developed lightheadedness, frontal headache and a feeling of "fuzziness." "I knew it was going to start." She describes a globus sensation. She developed nausea without vomiting. Took 40 mg of prednisone and 25 mg of diphenhydramine. EMS was contacted. She tells me that she lost vision and couldn't see the paramedics when they arrived. Discharged from ED, then returned on 3/17/21, when she began experiencing face itchiness and flushing, numbness of her mouth and lips, throat inflammation, and vision loss. Patient took Prednisone this morning with little symptom relief. Compared to yesterday, the only new symptom is throat inflammation. 4/30/21 Primary care visit: presents to the clinic for evaluation of globus sensation. Patient reports that this has been an issue ever since she got her first dose of Pfizer COVID-19 vaccine. She feels as though there is something in her throat and feels pain or discomfort, most often in the mornings and evenings for several weeks. She feels the need to "clear" her throat often. She denies any trouble eating or swallowing. She feels as though her neck and face still appear swollen compared to her baseline, since getting the vaccine. She reports occasional post nasal drip but denies significant nasal congestion and does not feel this is the typical time for her to struggle with her allergies. She has noticed frequent nose bleeds in the past 2 weeks, now daily. She states that she will sometimes bleed up to 15-20 minutes. She has been feeling more tired and "foggy" or more forgetful in the past few weeks as well and fears this is starting to affect her work performance.
44 2021-05-27 pain in extremity severe outbreak of multiple coldsores, lips and inside nostrils, severe itching and tenderness of s... Read more
severe outbreak of multiple coldsores, lips and inside nostrils, severe itching and tenderness of scalp only at the back near hairline. these all occurred approximately 3 days after receiving 2nd shot. These effects are in addition to the more common and expected ones, sore arm, mild flu symptoms, etc. coldsore outbreak was unusually painful, and severe. after discovering that many others experienced similar outbreaks after receiving vaccine I thought I should report it. I sought treatment through an online telehealth doctor and received prescription for valocyclovir.
44 2021-05-27 tingling have had off and on spotty bleeding but no monthly period; ringing in her ears; nausea; fever; eat h... Read more
have had off and on spotty bleeding but no monthly period; ringing in her ears; nausea; fever; eat half of what she normally ate; have had off and on spotty bleeding but no monthly period; anaphylaxis reaction; throat to stop feeling like it was closing up; severe headache; sinus pain that felt like someone punched her in the face; all over tingling sensation 20 minutes after getting the shot; chills; This is a spontaneous report from a non-contactable consumer (patient) via COVAES. A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 18Apr2021 13:15 (Batch/Lot Number: ew0151) as 2nd dose, single dose (at the age of 44-years-old) for COVID-19 immunisation. Medical history was not reported. The patient did not have any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medication within 2 weeks of vaccination. The patient has not been diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient received his first dose of BNT162B2 on the left arm on 26Mar2021 17:30 (batch/lot number: er8127) for COVID-19 immunisation and experienced extreme structural pain and severe flu like symptoms for 4 days. The patient reported that on the second shot, she had anaphylaxis reaction along with severe headache, sinus pain that felt like someone punched her in the face, and all over tingling sensation 20 minutes after getting the shot. She had to drink 3 doses of BENADRYL for her throat to stop feeling like it was closing up. She then had ringing in her ears, nausea, fever, headache, and chills for 3 days. Since then, she can only eat half of what she normally ate. She has felt nauseated for a month and have had off and on spotty bleeding but no monthly period and a lingering headache that will not go away. The patient has yet to see her doctor due to COVID restrictions. The patient recovered from chills on an unspecified date. The patient has not recovered from headache. The outcome of the remaining events was unknown. No follow-up attempts are possible. No further information expected.
44 2021-05-28 breast pain, feeling hot, migraine I received the vaccine on Friday at 12pm. Late afternoon: fatigue, joint pain, swollen lymph nodes o... Read more
I received the vaccine on Friday at 12pm. Late afternoon: fatigue, joint pain, swollen lymph nodes on left side of upper body, swollen left breast with pain and heaviness feeling that lasted for 2-3 days, Lupus butterfly rash on face, flu-like symptoms, spike in temperature to 100º, dizziness, heat radiating off body, and migraine. I took my prescribed Meloxican (for Lupus joint/muscle pain) approx 2:30pm and then my prescribed Fioricet for the migraine. Friday evening: Approximately 8pm I broke out in hives on my trunk; stomach, chest, shoulders, and back. The migraine worsened to include nausea with sensitivity to light, sound and smell. I took my prescribed Zomeg with no relief. The migraine was so severe that it kept me in bed with pain for hours that once I had some relief to be able to stand to go look in the mirror at the hives, it was approximately 1am. I put hydrocortisone cream on the areas I could reach and took Benadryl. It took over an hour to fall asleep. Saturday: I took Allegra. The hives were still prominent and itchy. Sunday: The hives were still there but most were on my shoulders and back, while some still remained on my stomach but not as prominent. The hives were still itchy. The other symptoms have subsided except the migraine, which was dull, and fatigue. Monday: The hives were not as prominent but somewhat itchy. They were some remaining on my shoulders. They other symptoms subsided with the exception of a dull migraine which I managed with Fioricet. I made the first available appointment with my primary doctor. Tuesday: I saw my primary doctor. Per my physician I still have hives on my trunk. I was instructed to continue with interventions. As of 5/19/2021, I had been treating the hives, fatigue, and migraines which occurred unexpectedly. The hives have subsided completely by Thursday, 5/20/2021.
44 2021-05-28 burning sensation, migraine Hypertension (160); Intense migraine; hot arms; This is a spontaneous report from a contactable cons... Read more
Hypertension (160); Intense migraine; hot arms; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 05May2021 at 17:45 at 44 years (Lot Number: EW0170), as single dose, for COVID-19 immunisation. The patient's medical history was not reported. Patient did not have known allergies, did not have COVID-19 prior to vaccination, was not pregnant and was not pregnant at time of vaccination. Concomitant medication included unspecified birth control. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 10Apr2021 at 14:45 at 44 years (lot# EP7533) in left arm. Patient did not receive other vaccines in four weeks. The patient experienced hypertension (160) (medically significant) on 06May2021 at 06:00 with outcome of not recovered, intense migraine (medically significant) on 06May2021 at 06:00 with outcome of not recovered, hot arms (medically significant) on 06May2021 at 06:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood pressure: hypertension (160) on 06May2021. Therapeutic measures were taken as a result of the events and included treatment with lisinopril 20 mg. Patient did not tested for COVID-19 post vaccination. No follow-up attempts are needed. No further information is expected.
44 2021-05-28 fibromyalgia Extremely sick; Affected neurological; Increased pain in fibro; This is a spontaneous report from a ... Read more
Extremely sick; Affected neurological; Increased pain in fibro; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the right arm on 21Apr2021 (10:30) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included fibromyalgia; complex regional pain syndrome (CRPS); small fiber neuropathy; brain lesions; thrombocytopenia; chronic arthritis; nerve damage in elbows and hands; tree nut allergy; shellfish allergy; and allergy to lots of medications. The patient was not pregnant at the time of vaccination. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). On 12May2021, the patient was extremely sick; affected neurological; and had increased pain in "fibro". The events had resulted into doctor or other healthcare professional office/clinical visit. The patient had received prednisone, diphenhydramine (BENADRYL) and epinephrine as treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested. Additional information has been requested.
44 2021-05-28 tingling, breast pain, pain in extremity RA flare up on my left side of my body; I"m still in a lot of pain; I've had tingling in my hand and... Read more
RA flare up on my left side of my body; I"m still in a lot of pain; I've had tingling in my hand and pain in my left breast; I've had tingling in my hand and pain in my left breast; sharp shooting pain in my arm that continued for an hour. Then my arm was very stiff and sore.; sharp shooting pain in my arm that continued for an hour. Then my arm was very stiff and sore.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 05May2021 at 14:30 (at the age of 44-years-old) at 1st dose, single dose for COVID-19 immunization. Medical history included rheumatoid arthritis (RA), injuries, surgery, Celiac (dairy and gluten made her very sick), Hashimoto's, and ACL repair on left knee. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (T3), and naltrexone. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as unknown. Since the vaccination, the patient has not been tested for COVID-19. Minutes after injection on 05May2021, the patient experienced a sharp shooting pain her arm that continued for an hour, then her arm was very stiff and sore. She then had an RA flare up on the left side of her body where she had several injuries and surgery on 06May2021. It's been over two weeks and she was still in a lot of pain, additionally, she had tingling in her hand and pain in her left breast, all of which started in 06May2021. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
44 2021-05-29 muscle twitching Constant Muscle twitching left abdomen under heart
44 2021-05-30 inability to speak, migraine Left arm (deltoid) pain, swelling, knot in the muscle larger than my entire hand, redness, hot to th... Read more
Left arm (deltoid) pain, swelling, knot in the muscle larger than my entire hand, redness, hot to the touch. Migraine, severe fatigue, muscle and joint pain to the point of barely being able to move from the bed, not able to take a deep breath without pain, brain fog, loss of concentration, difficulty with word recall
44 2021-05-30 weakness, numbness The day after my second dose of Pfizer, my legs would get extremely weak and sort of half-numb after... Read more
The day after my second dose of Pfizer, my legs would get extremely weak and sort of half-numb after my evening shower, every night. This was most notable for about a week afterwards, but is still somewhat the case even now, 5 weeks later. The half-numb feeling also persists outside of showers, such as with casual walking around and taking longer walks. I have had this kind of feeling in the past, but it hasn't been a problem for several years. The leg weakness post-showers is new, as of taking the second dose of the vaccine.
44 2021-05-31 weakness "On 1/9 felt severe flu-like symptoms (chills, fever, nausea, dizziness, headache), and stayed in be... Read more
"On 1/9 felt severe flu-like symptoms (chills, fever, nausea, dizziness, headache), and stayed in bed until 1/10. Felt fine midday, 1/12, then sudden, intense migraine, ear/sinus pressure/pain, dizziness, blurred vision, weakness, tired. Symptoms improved but were still present the next day."
44 2021-05-31 feeling cold body aches (like growing pains in the joints); I was fatigued; Arm where vaccine was given was sore;... Read more
body aches (like growing pains in the joints); I was fatigued; Arm where vaccine was given was sore; I was very cold; swollen lymph node in the armpit of the arm where vaccine was given.; Chills lasted until about 24 hours after vaccine was given; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL 9264), via unspecified route of administration in the left arm on 05Feb2021 at 06:30 PM, as single for COVID-19 immunization at Public Health Clinic. The patient's medical history included hypothyroidism, high cholesterol, acid reflux, gallbladder stone, overweight and seasonal allergies that last all year. The patient was not allergic to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), omeprazole, montelukast sodium (SINGULAIR), levocetirizine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: E13247), via an unspecified route of administration in the left arm on 14Jan2021 at 06:30 PM, as single dose for COVID-19 immunisation. On 06Feb2021 at 07:30 AM, 12-13 hours after the vaccine: body aches (like growing pains in the joints), she was fatigued, was very cold. Arm where vaccine was given was sore and swollen lymph node in the armpit of the arm where vaccine was given. Chills lasted until about 24 hours after vaccine was given. Body aches went away about 30 hours after vaccine was given. Swollen lymph node still swollen 2.5 days after vaccine. Took Tylenol about 19 hours after vaccine and it seemed to take the edge off the aches. Took 1 more dose of Tylenol 6 hours later and that's all she needed. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events body aches (went away about 30 hours) and chills (was lasted until about 24 hours) was recovered on 07Feb2021; swollen lymph node was not recovered; for rest of events was recovering. Follow-up attempts are completed. No further information is expected.
44 2021-05-31 tremor Patient went to ED with possible vaccine related reaction. CHIEF COMPLAINT: POSSIBLE ALLERGIC REA... Read more
Patient went to ED with possible vaccine related reaction. CHIEF COMPLAINT: POSSIBLE ALLERGIC REACTION (sx p 2nd covid vax rec'd vax and was being observed developed sl dizziness and legs got weak and started shaking, en route w/ ems she felt like her tongue got thick 0.3 epi admisitered per EMS. on arrival pt is trembling but denies feeling cold, hypertensive, NSR oropharyx clear LS CTA b/l c/o feeling thirsty dry mouth after epi. obtained manual bp d/t trembling) The patient is an otherwise healthy 44-year-old female who presents to the emergency department today via EMS with concerns for an allergic reaction. The patient states she just received her 2nd Covid-19 vaccine (Pfizer) when about 15 minutes after, noticed a bilateral lower extremity weakness, dizziness, as well as dry mouth. EMS did provide IM epinephrine given at roughly 3:30 p.m.. The patient was further brought to the emergency department for further evaluation and monitoring. Patient states she has not noticed any rashes or itching, is not having any shortness of breath or trouble breathing. She states that she does have dry mouth, but is not having any sensation such as a difficulty swallowing or swelling. No headaches. No chest pain, abdominal pain, back or neck pain. No nausea vomiting dysuria or hematuria. MEDICAL DECISION MAKING The patient was seen upon arrival in the emergency department. She remained stable from a respiratory and hemodynamic standpoint. She presents status post IM epinephrine after feeling dizzy with a bilateral lower extremity weakness and shaking after the COVID-19 vaccine. On my initial evaluation, she does appear well, without any concerning propagation of an allergic response. She was monitored here in the emergency department for about 2-1/2 hours with no a change in her clinical status. She is almost 3 hours out from her IM epinephrine dose, and is feeling better. She is tolerating fluids. Does not have any posterior or pharyngeal swelling or sensations at this time, so I do feel comfortable with discharge home. Return precautions were discussed, the patient was discharged in stable condition.
44 2021-05-31 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was seated after vaccination the... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was seated after vaccination then collapsed. I went over after was alerted and flipped patient from her face. She was awake but confused at what happened. I sat with her while she came to and our front store manager got her water. She was breathing well and was starting to become aware, and she refused an offer to call an ambulance. We sat until she felt comfortable to get up and the store manager walked with her. She reported to himthat was not the first time she had passed out that day
44 2021-05-31 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was seated waiting after her vac... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was seated waiting after her vaccination. She collapses to the floor. I went out after being alerted what happened and flipped her from her face, she was awake and confused as to what had happened. I sat with her while our front store manager grabbed her water. I asked if she felt she needed an ambulance and seeing as she was breathing fine and starting to come to she said she did not want an ambulance. She later informed our front store manager that she had fainted 3 times that morning.
44 2021-06-01 limb paralysis, pain in extremity Sore arm started about 6 hours later and lasted about 24 hours Dizziness started within half an hour... Read more
Sore arm started about 6 hours later and lasted about 24 hours Dizziness started within half an hour intermittent for 48 hours Extreme sensitivity to normal noises and lights started 20 hours after, lasted 4 hours Shooting, intermittent pain in upper left quadrant of chest, started 6 hours after, ongoing, 30 hours out also occasionally in right shoulder/chest, and left side of neck Partial PARALYSIS of left arm starting about 3 hours after, significant worsening 40 hours after and ongoing
44 2021-06-01 muscle spasms left arm was stiff this morning; injection site pain; she just realized the Arnicare Gel was expired... Read more
left arm was stiff this morning; injection site pain; she just realized the Arnicare Gel was expired, saying she was surprised the Arnicare Gel still worked; has a charley horse pain in her left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 02Feb2021 as 1st dose single for COVID-19 immunization. Medical history included microcytic anemia and thalassemia from an unknown date and unknown if ongoing. Restless legs syndrome from 2015 to an unknown date Verbatim. Concomitant medications included cyanocobalamin, biotin and folic acid taken for microcytic anemia from an unspecified start date and ongoing. Ethinylestradiol, norgestimate taken for hormone therapy from Oct2020 and ongoing. She said she started taking Estarylla 0.25mg/0.035mg oral birth control pill for hormone regulation in Oct2020, saying she has been taking the Estarylla for 4 months steady now. The patient previously took ropinirole for Parkinson's disease and experienced syncope from an unspecified date. Reported she tried the Parkinson medicine, Ropinirole, and that the Ropinirole knocked her out, and she didn't like that, so she stopped taking the Ropinirole 2 years ago. On 02Feb2021 patient experienced has a charley horse pain in her left arm, injection site pain and she just realized the Arnicare gel was expired, saying she was surprised the arnicare gel still worked. Left arm was stiff this morning on 03Feb2021. Stated she has a bad left shoulder, saying she thinks she has a pinched nerve, so she asked to get the vaccine in her left arm. She said her left arm pain has improved on 03Feb2021. Therapeutic measures were taken as a result of he has a charley horse pain in her left arm and left arm was stiff this morning. Treatment received with Arnica gel to help with the left arm muscle soreness. She said the Arnica gel helped. The outcome of the events was recovered, whereas injection site pain was recovering. Follow-up attempts are completed. No further information is expected.
44 2021-06-02 flushing Felt flushed and itchy right after. Broke out in cold sores within 28 hours of second shot.
44 2021-06-02 pain in extremity mild symptoms - like headache and sore arm; mild symptoms - like headache and sore arm; This is a sp... Read more
mild symptoms - like headache and sore arm; mild symptoms - like headache and sore arm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EH9899 and expiration date: not reported), dose 1 via an unspecified route of administration on 17Dec2020 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. There were no any other product that were taken together with vaccine. The patient experienced mild symptoms-like headache and sore arm on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
44 2021-06-02 pain in extremity After her first COVID-19 Vaccine, she had a sore left arm; after her first COVID-19 Vaccine, she had... Read more
After her first COVID-19 Vaccine, she had a sore left arm; after her first COVID-19 Vaccine, she had a low level headache; This is a spontaneous report received from a contactable consumer or other non hcp (patient herself). A 44-year-old Hispanic female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0176) via intramuscular route of administration, administered in left arm on 05May2021 as 1st dose, single for covid-19 immunization. The patient's medical history was reported as none and concomitant medications were not reported. On 05May2021 after her first covid-19 vaccine, she had a sore left arm that didn't hurt as much as other vaccines she had received, and a low level headache. The patient did not visited Emergency Room or Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient took Tylenol 500 mg tablet and was fine afterwards. The patient said she was very happy when she only had a sore arm after her first COVID-19 Vaccine because she always kind of got sick with vaccines .The outcome of the events was recovered on an unspecified date in May2021.
44 2021-06-02 pain in extremity Arm swelling/soreness, nausea, chest was hurting (found spot on the lung), coughing hard causing blo... Read more
Arm swelling/soreness, nausea, chest was hurting (found spot on the lung), coughing hard causing blood to come out
44 2021-06-02 speech disorder on day 4, patient thought she was having a stroke, had sob and heart palpitations, face had numbness... Read more
on day 4, patient thought she was having a stroke, had sob and heart palpitations, face had numbness, trouble thinking and speaking, went to er, er was very busy, left and went to urgent care, had ekg and tested for clotting and thyroid, all tests came back clear. symptoms resolved on their own. patient will be following up in the future with cardiologist
44 2021-06-03 weakness Weakness; Dizziness; Rash; tiredness; headache; muscle pain; joint pain; fever; body aches; nausea; ... Read more
Weakness; Dizziness; Rash; tiredness; headache; muscle pain; joint pain; fever; body aches; nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old non pregnant female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Left arm on 02Mar2021 15:30 (Batch/Lot Number: EN6200, Expiration date: unknown) as 1st DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included fibromyalgia from an unknown date, rubber sensitivity from an unknown date. Concomitant medications included armour thyroid, duloxetine hydrochloride (cymbalta), vitamin d, vitamin c [ascorbic acid]. The patient previously took codeine and experienced drug hypersensitivity. On 04Mar2021 08:00 am the patient experienced weakness, dizziness, rash, tiredness, headache, muscle pain, joint pain, body aches, nausea. Outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.
44 2021-06-03 breast pain Sharp stabbing pain/throbbing under left breast.
44 2021-06-03 feeling hot Got shot at 4pm, waiting 15 min. At Pharmacy went home and developed a rash on my upper body, it was... Read more
Got shot at 4pm, waiting 15 min. At Pharmacy went home and developed a rash on my upper body, it was light at first, then faded and came back 15 min. Later & was red and blotchy and felt like my skin was burning/on fire/felt so warm and my heart was racing. The Rash traveled down my arms- more so on the arm where the injection was. It also traveled up my chest and was really red there and went up my neck and my ears & nose were extremely red and I felt like I might pass out. I then went to Urgent Care and called my Dr. URGENT CAEE gave me dexamethasone Sod Phosphate PF 10MG solution to swallow, which Dr. Said it would last up to 4 days in system. and I took Benadryl 50mg. The rash disappeared that night on 6/3/21. On 6/4- it hasn't returned.
44 2021-06-03 feeling jittery Tachycardia, jittering. After taking antihistamine, symptoms lessened. Continued for two more days, ... Read more
Tachycardia, jittering. After taking antihistamine, symptoms lessened. Continued for two more days, continual use of antihistamines and resolved completely after 4 days
44 2021-06-03 pain in extremity, breast pain, muscle spasms 3 hours after injection, developed profuse sweating on neck in air conditioned room followed by hive... Read more
3 hours after injection, developed profuse sweating on neck in air conditioned room followed by hives on neck and chest, itching, pain. was advised to take benadryl. fell asleep within one hour. Hives reoccured every day for one week. I still have redness and bumps. 12 hours after injection, developed very sore arm, pain with range of motion, headache which resolved with Motrin, fatigue-slept 18 hours. 3 days after injection developed diarrhea which is still occuring 3 weeks after. developed severe PMS 2 weeks earlier than usual which has never happened. Breasts not just tender-they hurt. terrible cramps, which i never get. bleeding through super ultra tampon every 45 minutes which has never happened. Unable to exercise because of dizziness and fatigue. I typically exercise 5 days per week including jogging, hiking, resistance training. today, June 3, I became very confused and felt like my brain wasnt sending signals to my body. I cannot remember what I needed to do 5 minutes ago. I went to fill up my sink to do dishes and poured water on the counter instead of drain, I poured coffee in my eye.
44 2021-06-03 pain in extremity Soreness developed on my right side in the evening on Saturday, May 22nd, approximately one week aft... Read more
Soreness developed on my right side in the evening on Saturday, May 22nd, approximately one week after receiving the second dose of the COVID vaccine. The next day on Sunday, May 23rd, I noticed the rash where the soreness was on the right side. A day or two later, a rash appeared on my back on the right side. I called the doctor on Monday, May 24th, received a video conference appointment and received a prescription for Valtrex on Monday, May 24th, which I started on that day. I was on this for 5 days. My doctor examined me on June 4th an confirmed that it was shingles. My 80 year old mother with whom I live had shingles two weeks before I experienced my first symptoms. She got sick 2 weeks after her first Pfizer dose. About 2 weeks after she got sick, she then developed shingles. She had shingles a couple of years before.
44 2021-06-03 tremor Pt w/ dizziness, pre-syncope, shakes, muscle weakness, pallor. BP 121/72, HR 83, RR 16. Pt stable ... Read more
Pt w/ dizziness, pre-syncope, shakes, muscle weakness, pallor. BP 121/72, HR 83, RR 16. Pt stable and released from the vaccination site.
44 2021-06-04 numbness, tingling Numbness in face/ Numbness in feet; Light headed/ Dizzy; Severe lethargy; GI distress; Low grade fev... Read more
Numbness in face/ Numbness in feet; Light headed/ Dizzy; Severe lethargy; GI distress; Low grade fever; very minor almost non existent tenderness atinjection site; Face and feet are tingly; This is a spontaneous report from non-contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6199), via an unspecified route of administration in the right arm on 16Mar2021 at 10:00 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was allergic to Senna, reaction to latex (but not an allergy) and seasonal allergies. It was reported as unknown, whether the patient was diagnosed with COVID-19, prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 09:00, the patient's face and feet were tingly a tiny bit numb, felt light headed and dizzy, sudden onset of moderate to severe lethargy, upset stomach, mild to moderate gastrointestinal distress, very minor, almost non-existent tenderness at injection site, a tiny bit warm at site and low-grade fever. On an unspecified date, the patient received treatment with TYLENOL and then ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of the events numbness, tingling, light headed, lethargy, distress gastrointestinal, vaccination site tenderness and low-grade fever were recovering. No follow-up attempts are needed. No further information is expected.
44 2021-06-04 pain in extremity low-grade fever; chills; headache; body aches; sore arm; This is a spontaneous report from a non-con... Read more
low-grade fever; chills; headache; body aches; sore arm; This is a spontaneous report from a non-contactable consumer. A 44-years-old female patient received second of BNT162B2(Formulation: Solution for injection; Batch/Lot number), dose 2 via an unspecified route of administration, administered in Arm Right on 05Mar2021 09:00 AM as 2ND DOSE SINGLE DOSE for covid-19 immunisation. Medical history included allergy with Penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 02:00 PM as 1ST DOSE SINGLE DOSE for covid-19 immunisation. Patient did not received any other vaccines within 4 weeks. On 05Mar2021 21:00 AM patient experienced low-grade fever, chills, headache, body aches, sore arm. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
44 2021-06-05 mild one side paralysis Developed a R ICA acute thrombus (seen on CTA) and arrived with significant left sided weakness as ... Read more
Developed a R ICA acute thrombus (seen on CTA) and arrived with significant left sided weakness as a code stroke on 6/5. Received tPA and went for thrombectomy to evaluate the acute R ICA occlusion further which was found to be patent (thought to be due to tPA effect). After tPA, pt has complete resolution of weakness. MRI brain found a R striatum acute infarct. Pt was on an estrogen oral contraceptive medication, nonsmoker. Healthy with no hematologic conditions (no prior bleeding or clotting issues). No chronic medical conditions and healthy (would run 6 miles a day, etc), on no other medications or over the counter supplements.
44 2021-06-06 difficulty speaking immediate pain, achiness everywhere, severe joint pain, change in voice, pleurisy, distant heart sou... Read more
immediate pain, achiness everywhere, severe joint pain, change in voice, pleurisy, distant heart sounds, tachycardia, fever requiring multiple outpatient rheumatology and primary care visits, essentially necessitating hospitalization. Work up shows new + ANA, low complements, + histone, consistent with drug-induced lupus
44 2021-06-06 flushing Patient Reported feeling flush and having chest tightness
44 2021-06-07 bell's palsy Blotchy skin.; Throwing up; Bells Palsy; This is a spontaneous report from a contactable consumer. A... Read more
Blotchy skin.; Throwing up; Bells Palsy; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03May2021 (Lot Number: EW0170) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included alprazolam (XANAX) and buspirone (BUSPIRONE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination the patient did not diagnosed with COVID-19. The patient experienced blotchy skin, throwing up, bells palsy on 08May2021 18:00. Treatment received for the events. Outcome of events was not recovered. The patient was hospitalized for the events for 2 days. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Events were reported as serious due to hospitalization, disability. Since the vaccination the patient had not been tested for COVID-19.
44 2021-06-07 hot flush, night sweats I experienced a heavy period which came early. After that I haven't had a period in 6 months. I'm ha... Read more
I experienced a heavy period which came early. After that I haven't had a period in 6 months. I'm having night sweats, irritably, hot flashes. And I am not pregnant.
44 2021-06-07 tremor Patient experienced immediate side effects right after her first dose of Pfizer Covid vaccine. The ... Read more
Patient experienced immediate side effects right after her first dose of Pfizer Covid vaccine. The symptoms including shortness of breath, chest tightness, tremor and nausea. The pharmacist on duty had to call for 911 due to her conditions.
44 2021-06-07 tremor Sinus tachycardia; Edema; I had a 'tremor' and both of my legs; My heart rate has been a 140 ever si... Read more
Sinus tachycardia; Edema; I had a 'tremor' and both of my legs; My heart rate has been a 140 ever since then; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: I38731) via an unspecified route of administration, administered in right arm on 21May2021 (at the age of 44 years old) as a single dose for COVID-19 immunization. Medical history included Long COVID, cardiac arrest (twice), bilateral pulmonary embolism, four upper extremity DVT (deep vein thrombosis), blood clot from an unknown date and unknown if ongoing. No family medical history of adverse effect. Concomitant medication included apixaban (ELIQUIS) 2.5 mg tablet in the morning and night to prevent blood clot, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW6955) dose 1 via an unspecified route of administration on 28Apr2021 as 1st dose, single dose for COVID-19 immunization and it made her sick. The patient reported that she had a vaccine reaction that just needed to report. The patient had long COVID, tested positive in January. The patient waited for 90 days before she could be vaccinated for her first vaccine. The patient got her 2nd vaccine on 21May2021 4:30 in the evening and her heart rate had been 140 ever since then. She had a tremor and both of her legs. She went to cardiologist and doctor told to call and let Pfizer know about tachycardia. The patient stated that she woke up Saturday morning 22May2021 with tachycardia. He had done an EKG (electrocardiogram). It was just normal sinus tachycardia, there was no arrhythmia, heart rate was 68 to 78. The patient reported that it was the side effect of the vaccine. The patient stated that her cardiologist said there was nothing that can be done. The doctor told her to wear compression stroking for the edema which she had done since she follow him and her heart rate was coming down and it was down to like 120's now but doctor told her that it will eventually come down on its own, there was a medication and there was nothing to do. The doctor did have her on a heart monitor, so he can watch her rhythm and heart rate but stated there was a medication. The patient underwent lab tests and procedures which included electrocardiogram: normal on 28May2021 Normal sinus Tachycardia, heart rate: 140 on 28May2021, Cardiac magnetic resonance imaging: unknown on 28May2021. The clinical outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
44 2021-06-08 flushing Light-headed, face flushed 11:36 am No rash, no itching, no SOB, chest tightness or wheezing Lied do... Read more
Light-headed, face flushed 11:36 am No rash, no itching, no SOB, chest tightness or wheezing Lied down, drank water, vital stable q5-10min Discharged: 12:10pm - stable Home by car with husband. Walking unassisted. Given instructions for ER follow up if new or worsening symptoms
44 2021-06-08 pain in extremity Anytime I exerted myself it get worse so I went to the hospital and they admitted me because they co... Read more
Anytime I exerted myself it get worse so I went to the hospital and they admitted me because they couldn't control my angina; Bypass had developed a huge blood clot; Hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed.; Chest Pain; Nose bleed; Light headedness/light headed and dizzy; Hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed.; Hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed.; My arm hurt; This is a spontaneous report from a contactable consumer (reported for herself) via the Pfizer sponsored program. A 44-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left upper on 07Apr2021 (Batch/Lot Number: ER8735) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 44 years old. Medical history included coronary artery disease, Microvascular disease, migraine, Bypass of LAD artery with my LIMA artery, angioplasty, had open heart surgery before, all from an unknown date and unknown if ongoing. Historical vaccine included first dose of Pfizer COVID-19 Vaccine on 10Mar2021 at the age at vaccination of 43 years old (got the first shot in right upper arm) for covid-19 immunization. Concomitant medications included clopidogrel bisulfate (PLAVIX); lisinopril; amlodipine; rosuvastatin calcium (CRESTOR); fluoxetine hydrochloride (PROZAC); clonazepam (KLONOPIN), Nexletol (further clarification unknown). The patient experienced anytime i exerted myself it get worse so i went to the hospital and they admitted me because they couldn't control my angina on Apr2021 with outcome of unknown, bypass had developed a huge blood clot on Apr2021 with outcome of unknown, chest pain on 19Apr2021 with outcome of not recovered, nose bleed on 08Apr2021 with outcome of recovered on unknown date, light headedness/light headed and dizzy on Apr2021 with outcome of unknown, hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed (hematoma) on Apr2021 with outcome of recovered on 19Apr2021, hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed (Bruising of arm) on an unspecified date with outcome of unknown, hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed (Swelling arm) on Apr2021 with outcome of unknown, my arm hurt on Apr2021 with outcome of unknown. The patient underwent lab tests which included lipids: unknown (had lipid channel), something checking for heart stress: unknown, both on unknown date. Therapeutic measures were taken as a result of angina attack, chest pain, nose bleed, hematoma, Bruising of arm, Swelling arm and Pain in arm. Seriousness for events "anytime i exerted myself it get worse so i went to the hospital and they admitted me because they couldn't control my angina" and "bypass had developed a huge blood clot" was hospitalization, medically significant. The patient was hospitalized for both events from 20Apr2021 to 23Apr2021. Events chest pain, Light headedness/light headed and dizzy resulted in Emergency Room Visit. Additional information: Transferring agent stated, "I have patient on the line today and the reason for my transfer today is that she is having adverse effects from the COVID-19 Vaccine, she did clarify it is the Pfizer COVID Vaccine and she is experiencing hematoma on her arm a couple of days later after that it was swollen, bruises she got nose bleed as well and on 19th April that she was experiencing chest pain she went to ER and they were thinking it was cause of the COVID Vaccine as well." Consumer stated, "On 07Apr2021, I have the LOT number and everything of the vaccine I received for both of them on 07Apr2021, I got the Pfizer the second Pfizer shot and I developed a hematoma on my arm which was as big as a baseball. It was really swollen and I take blood thinners and on the next day on 04-08, I started getting a lot of nose bleed. I never get a nose bleed and so I called my doctors and asked what should I do and she said stop taking your blood thinners so I stopped taking the blood thinners and then may be after 7 days, I started taking my blood thinners again. So, it took about 3 weeks for the hematoma to go away on 04-19th, I had a huge chest pain, I have had open heart surgery before and I had to go to the ER because I felt light headed and dizzy. My arm hurt, my chest, I took nitroglycerine (treatment) and it made still little better but anytime I exerted myself it gets worse so I went to the hospital and they admitted me because they couldn't control my angina and my cardiologist did an angioplasty (Further clarification unknown) and he found that my 2019, I had a bypass of LAD artery with my LIMA artery (Medical History) and he found that my bypass had developed a huge blood clot and failed. So, basically I am looking at go in and having another bypass using my LIMA artery but the surgeon, the coronary surgeon that I talking he wanted me to call Pfizer to let you guys know because he said that that is so weird that it failed and the shot and everything and he just wanted you guys to be aware and you know that's what we wanted safety because I know that when I went in I had a lot of a questions and none of my doctor could answer. It says I shouldn't take it if I am on blood thinners but they said it is still better than you getting COVID so I went ahead and took the shot but actually now I have to get a bypass again. It might be from the vaccine, it might not be from the vaccine but the timings is just you close together there." Patient took Nitroglycerin, she was on now but that's because of the chest pain so that was on before she had the chest pain when she had the shot (Further not clarified). When probed of the event is still ongoing: Consumer stated, "Yes, because my By pass graph is now failed." Treatment: Patient took Tranexa (name not clarified). It was a medicine for her chest pain. Outcome: Consumer stated, "As in nose bleed and bleeding are gone, now it is just chest pain". Follow-up attempts are completed. No further information is expected.
44 2021-06-09 bell's palsy it was determined I have Bell's Palsy; This is a spontaneous report received from a contactable cons... Read more
it was determined I have Bell's Palsy; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02May2021 13:00 (Lot number: EW0172) as single dose for (at the age of 44-years-old) COVID-19 immunization. Medical history included diabetes, sleep apnea, high blood pressure, neuropathy. The patient was not pregnant at the time of vaccination. No allergies. Unspecified concomitant medications were taken ("Yes my prescribed medications"). The patient reported that, "My face started getting droopy, my speech slurred and started having extreme facial pain. I went to my Primary Care Physician she did blood work and it was determined I have Bell's Palsy." Date of start of reaction was on 18May2021 07:15. The adverse event resulted in any Doctor or other healthcare professional office/clinic visit. Hospitalization not Prolonged. The outcome of event was not recovered. The event is serious (medically significant). Another dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered via an unspecified route of administration on 23May2021 03:00 PM, administered in Arm Left (Lot number: EW0172) as single dose for COVID-19 immunization (pending clarification). Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Additional information has been requested.
44 2021-06-09 burning sensation The two toes on my right foot have the sensation of burning and itching. There is no rash, but the ... Read more
The two toes on my right foot have the sensation of burning and itching. There is no rash, but the sensation comes and goes. Essentially Covid Toes.
44 2021-06-09 pain in extremity Initial reaction (2 days post): nausea, fever, chills, sore left arm, muscle aches 1month post-prese... Read more
Initial reaction (2 days post): nausea, fever, chills, sore left arm, muscle aches 1month post-present time: hip and knee pain, stabbing right ear pain, chronic fatigue
44 2021-06-10 weakness My arm was achy afterwards, but the next day I woke up feeling very sick to my stomach and wiped out... Read more
My arm was achy afterwards, but the next day I woke up feeling very sick to my stomach and wiped out. I was running a low grade fever and took some Tylenol and laid down. Later on in the day I continued to feel bad. Everything in my body aches and was super sore. I had a headache off and on all day. I didn't have much of an appetite. It is now two days since I for my second shot and I'm still feeling feverish one minute and sweaty the next. I still have no energy or very little.
44 2021-06-10 migraine, tingling Nausea, pins and needles, extreme aches, migraine over the course of 4 weeks since first shot.
44 2021-06-10 pain in extremity, tingling developed 'bumps' that are big like mosquito bites; left hand started tingling, pain, itching and gr... Read more
developed 'bumps' that are big like mosquito bites; left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left arm really swollen; left arm really swollen and irritated; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0182), via an unspecified route of administration in Arm Right on 03Jun2021 (age at vaccination 44years old) as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus diagnosed from 20 years ago. The patient's concomitant medications were not reported. She received her first dose of the Pfizer Biontech Covid 19 vaccine on 03Jun2021 in right arm/shoulder. On 05Jun2021, she started have problems with opposite side; left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection) and then she noticed the 'bumps'. Not only bumps but also itching and left arm really swollen and irritated. So to clarify, on the left side, she has 8 bumps on arm and elbow and one on her index finger. On her right side, she has one bump on right index finger and one on right arm (that was just noticed today). The area is Irritated, and she has tried cortisone, alcohol, hair dryer, but nothing is working. She took Benadryl last night and it helped her to get some sleep. The bumps are getting worse; they are not as swollen today, compared to yesterday. This was about mid-night on 05Jun2021. she has these little bumps, some are really big bumps, kind of like mosquito bites. there is no bite puncture, the bumps are hard and itchy. It is the same reaction she gets to a mosquito bite. she knows everybody is different. The bumps are hard and risen and hot to the touch and just itchy. her whole arm where the bumps are just itches. the bumps are on both hands, especially worse is on the left hand. The outcome of the events was unknown. Therapeutic measures were taken as a result of developed 'bumps' that are big like mosquito bites, left hand started tingling, pain, itching and gradually migrated up her left arm, left hand started tingling, pain, itching and gradually migrated up her left arm, left hand started tingling, pain, itching and gradually migrated up her left arm, left arm really swollen, left arm really swollen and irritated. Follow-up (07Jun2021): This is a follow-up spontaneous report from a contactable consumer. This 44-year-old female consumer (patient) reported that: Report Type, HCP postal address, Dates for Reading through side effects and is getting, has like these bumps, Suspect product information, Other Products, Patient History. No follow-up attempts are needed. No further information is expected.
44 2021-06-10 pain in extremity Second dose of Pfizer Covid-19 shot. Only sore arm for first 34 hours, with noticeable bump under sk... Read more
Second dose of Pfizer Covid-19 shot. Only sore arm for first 34 hours, with noticeable bump under skin at injection site. Then woke up at 4am (34 hours after injection) with very itchy rash across upper chest (front only, between neck and breasts), and some sweating. I must have itched enough in my sleep to break the skin before waking. No fever. Injection site bump had dissipated entirely.
44 2021-06-11 pain in extremity After the vaccine on Feb 2nd, i have not been able to raise my left arm, Its been so much PAIN for ... Read more
After the vaccine on Feb 2nd, i have not been able to raise my left arm, Its been so much PAIN for some time now, I have been trying to exercise and stretch the arm to no avail. The worse is the pain that radiate between my left shoulder, arm and neck. The first dose I got in January 12 and have just swollen lymph nodes and was ok after a week but have not recover from the 2nd dose. Its tough because i cannot lift anything with my left arm at this point and i have no medical insurance because i lost my full time job. I do not know if its as a result of the vaccine itself or the position of the injection but am really suffering. I will appreciate information on anything I can do to help my situation.
44 2021-06-12 tingling, pain in extremity, nerve pain 3 week duration: Parasthesia, chest pain, leg pain, nerve pain, headache, buzzing sensation, extrem... Read more
3 week duration: Parasthesia, chest pain, leg pain, nerve pain, headache, buzzing sensation, extreme burning pain in chest, random days of heart rate of 110, extreme fatigue resulting in loss of work. 5 week duration: Severe random nausea, trouble eating 6 week duration and continues: Tinnitus (never had this in my life), trouble hearing high frequencies. This entire vaccine experience has been the most awful health issue I have ever encountered. Will not get 2nd dose. People don't know to report otherwise you would know tinnitus is definitely a problem.
44 2021-06-13 numbness 1) Severe Joint Pain- Elbows, ankles, shoulder blades. 2) Numbness Neck, shoulders, chest, arms, han... Read more
1) Severe Joint Pain- Elbows, ankles, shoulder blades. 2) Numbness Neck, shoulders, chest, arms, hands, upper back
44 2021-06-13 pain in extremity, muscle spasms, electric shock sensation, tingling Received Shot, experienced dizziness, confusion immediately Evening of first day: was tired, did not... Read more
Received Shot, experienced dizziness, confusion immediately Evening of first day: was tired, did not feel "right". Next Day: Very tired, but hands and muscles in legs began to ache 2 days after shot: Stomach became severely swollen and painful. Felt like an endometriosis flare. Had extreme diarrhea for three days. Voiding roughly 12 times per day. Sore rectum, lower stomach, intestines. These symptoms of soreness lasted for 3 days or so. 3 days after shot: severe sadness. Crying, couldn't shake it. Pain all over body. Over the next week my body became more and more sore. My feet began to cramp and fold inwards like they were trying to bend in half. I could not sit on any hard surface as my legs and back hurt too bad to sit on anything but piles of pillows. I could not walk well as my feet were very sore. A week after shot began feeling electric shock feelings throughout my legs. Zaps of electricity. Hands still very sore. Legs felt like I'd lifted weights for a week. Day 10 following shot still experiencing severe pain. Heart began racing. Resting heart rate would jump to 130 upon standing. Still having episodes of heart racing. Forearm began spasming and would cause my middle and ring fingers on my right hand to contract and close against my palm. Could not hold right hand steady. Still experiencing pins and needles in hand and arm. Spasming and contractions stopped after a few days. While I understand that many of these are known side effects, I was also lead to believe that these side effects would last 3 days or so. These have lasted well beyond that window.
44 2021-06-13 pain in extremity On June 8, 2021 I noticed right shoulder/arm pain. Went to my dr on 6/9 and he ordered a port dye st... Read more
On June 8, 2021 I noticed right shoulder/arm pain. Went to my dr on 6/9 and he ordered a port dye study (I have a Bard Power Port for iron infusions that ended in February). The port was fine, everything flowing correctly. On 6/10, my right arm was swollen and discolored. My Dr told me to go to ER. A CT scan was done and showed 2 DVTs and 1 PE. I was admitted and started on IV heparin. I was on the IV heparin until 6/13 and then was switched to oral Eloquis 10mg twice daily. It is now 6/14, and I should be discharged sometime today. I will continue to be on Eloquis for 3 - 6 months.
44 2021-06-14 breast pain Then I started my period, I am post menopausal and have been for 5+ years; breast hurting/first it w... Read more
Then I started my period, I am post menopausal and have been for 5+ years; breast hurting/first it was more my nipples but then it was the whole area/hurt to be touched, or even hurt when given a hug; breast hurting/first it was more my nipples but then it was the whole area/hurt to be touched, or even hurt when given a hug; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 19May2021 10:45 (lot number was not reported), as 1st dose, single dose, at age 44 years old, for COVID-19 immunization, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient has no medical history and no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported "Intense, I noticed my breast hurting, first it was more my nipples but then it was the whole area. They hurt to be touched, or even hurt when given a hug. Then I started my period, I am post-menopausal and have been for 5+ years." The onset date of the events was 22May2021. No treatment was given for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
44 2021-06-15 pain in extremity After receiving the 1st dose a pain presented in the arm and swelling. After weeks strong pains bega... Read more
After receiving the 1st dose a pain presented in the arm and swelling. After weeks strong pains began in the bones that extended throughout the whole body. With cause to this I have been unable to exercise because the pain is too strong.
44 2021-06-15 tingling PATIENT DEVELOPED PUFFINESS OF THE EYES, A SENSATION OF "FULLNESS" IN THE FACE, THE SENSATION OF PIN... Read more
PATIENT DEVELOPED PUFFINESS OF THE EYES, A SENSATION OF "FULLNESS" IN THE FACE, THE SENSATION OF PINS AND NEEDLES IN BOTH ARMS, AND THE FEELINGS WORSEN UPON STANDING UP. A BANOPHEN 50 MG WAS ADMINISTERED ORALLY ALONG WITH A BOTTLE OF WATER AND ASKED TO WAIT LONGER IN THE LOBBY. PATIENT STATED FEELING BETTER APPROXIMATELY 10 MINUTES AFTER TAKING THE BENADRYL AND INSTRUCTED TO TAKE ANOTHER DOSE OF BENADRYL 4 TO 6 HOURS LATER IF NEEDED.
44 2021-06-16 burning sensation, pain in extremity Shingles; Really fatigued; Took a nap; Had a low grade fever; Getting a little rash to her left butt... Read more
Shingles; Really fatigued; Took a nap; Had a low grade fever; Getting a little rash to her left butt cheek and it got worse and was spreading and oozing; Oozing; Burning; Itching; Her 2nd dose is when this began and states she had soreness in her arm; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 28Apr2021 14:00 (Batch/Lot Number: EW0170) as 2ND DOSE, SINGLE for covid-19 immunization. Patient had received her 1st dose of bnt162b2 vaccine (Batch/lot number: EW0158 administered left arm ) on 07Apr2021. Patients' Medical history was not known. Concomitant medications include multivitamins. The patient was not hospitalized, no Prior vaccinations were taken within 4 weeks, no AE prior to vaccinations, no Relevant tests were done. After 1st dose patient experienced sore arm. After her second dose patient experienced shingles- herpes zoster, fatigue, took a nap- somnolence, low grade fever- pyrexia, a little rash to her left butt cheek and it got worse and was spreading and oozing- skin weeping, burning sensation, itching- pruritus, soreness in her arm- pain in extremity. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit. Patient took Tylenol for fever, antiviral medication for shingles, ointments like Neosporin (expiry date is Jul2022 and lot is 2210 LZ/1 imprinted on the bottle and the box has lot 2210LZ with UPC number 0081074688, and is dual action strength ointment and pain relief), Hydrocortisone 1% and is Cortisone 10 (expiry date Oct2023, lot 20L109 and UPC on the box of 4116703396) and it is water resistant itch relief. The outcome of events was unknown. Follow-up (17May2021): This is a follow up spontaneous report received from a contactable consumer. No new information was recorded. Information on Lot/Batch number was available. Additional information has been requested.
44 2021-06-16 burning sensation leg was burning/ burning sensation on the leg and also on right foot/ veins are burning; The caller ... Read more
leg was burning/ burning sensation on the leg and also on right foot/ veins are burning; The caller has a lot of pain to the point; The caller cannot even walk; She could not sleep; This is a spontaneous report from a contactable consumer. A 44-years-old female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0217; expiry date and NDC number were reported as unknown) via an unspecified route of administration on 09Jun2021 in right arm as a single dose for covid-19 immunization. Medical history included ongoing varicose vein which started years ago. The patient's concomitant medications, investigation assessment and other products were not reported. On 09Jun2021 at 17:00 after receiving the first dose Pfizer Covid 19 Vaccine the patient felt like her leg was burning and had a burning sensation in the leg and also on right foot. She had lot of pain to the point where she could not sleep and had to get up. She was not able to walk. She already had the varicose veins before the vaccine but did not had the sensation, she was aware that varicose veins can be dangerous and can give thrombosis. The outcome of the event burning leg was not recovered and for all other events was unknown. Follow-up attempts are needed. Further information has been requested.
44 2021-06-16 migraine 1st dose: Migraine headache with scintillating scotoma after 12 hours.Fatigue for 1 week. Much heavi... Read more
1st dose: Migraine headache with scintillating scotoma after 12 hours.Fatigue for 1 week. Much heavier more painful period.; 1st dose: Migraine headache with scintillating scotoma after 12 hours.Fatigue for 1 week. Much heavier more painful period.; 1st dose: Migraine headache with scintillating scotoma after 12 hours.Fatigue for 1 week. Much heavier more painful period.; This is a spontaneous report from a contactable consumer (patient). The 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) via an unspecified route of administration at left arm on 15Mar2021 at 5:00 PM a single dose and second dose on 10Apr2021 at 10:00 AM (lot number: EPV0150 (might be ERV0150)) for COVID-19 immunization at a hospital. The patient's concomitant medications included Levothyroxine, Bupropion and Adderall. Patient medical history included hashimotos hypothyroid. No allergies were reported. Prior to vaccination patient did not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on an unspecified date after 1st dose patient experienced migraine headache with scintillating scotoma after 12 hours. Patient experienced fatigue for 1 week and much heavier and more painful period. On an unspecified date after 2nd dose patient experienced fatigue for 24 hours and much heavier and more painful period with palm sized blood clot. It was reported that outcome of events was resolved. No treatment was received. No follow-up attempts are possible. No further information is expected.
44 2021-06-16 pain in extremity sore throat; runny nose; hurt to swallow; allergies; having chills a few hours later/shivering; musc... Read more
sore throat; runny nose; hurt to swallow; allergies; having chills a few hours later/shivering; muscle pain; joint pain/hips were a little sore; low level headache; her left arm hurts; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 intramuscular, administered in Arm Left on 26May2021 15:15 (Batch/Lot Number: Ew0185) as 2nd dose, single for covid-19 immunisation. Medical history included latex allergy. The patient's concomitant medications includes unspecified supplement and vitamins. The patient previously received first dose of bnt162b2 on 05May2021 15:30 (lot number: Ew0176) in the left arm and experienced arm discomfort and headache. Prior to vaccination, the patient was not diagnosed with COVID-19 and the vaccination, has the patient been tested for COVID-19. On 26May2021, few hours after receiving the vaccine, the patient started having chills, muscle pain and joint pain. The patient had a low level headache, and her left arm hurts, but not as much as yesterday (27May2021). She said she woke up the next day (27May2021 05:00AM) with a sore throat on one-side of her throat, and on the roof of her mouth making it hurt to swallow. She said she was not sure if her sore throat was from allergies because she had a runny nose, too. She said her chills come and go and were not as bad as on Wednesday (26May2021). She said her sore throat was persisting. As treatment for the events, the patient took 2 Tylenol (500mg tablets) that night (26May2021). She said yesterday (27May2021), she took 2 Benadryl 25mg pink & white capsules) so she could go back to sleep. Reported her inside house temperature was 82 degrees (Fahrenheit) this morning, and she was in winter pajamas and still shivering. The patient was a supervisor, and was always having to talk at work, so she took a day off from work because she didn't think she could talk all day with her sore throat. She said she worked yesterday for only 5 hours. She said normally she doesn't take off from work, but she was in too much discomfort from the muscle pain, joint pain, and sore throat. She said her symptoms had improved since yesterday (27May2021), but when she went to take the garbage out, her hips were a little sore. The outcome of event runny nose, sore throat, allergies and hurt to swallow was not recovered; all other events was recovering.
44 2021-06-16 pain in extremity Sore arm; Moderate Headache; This is a spontaneous report from a contactable consumer, the patient. ... Read more
Sore arm; Moderate Headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 at 09:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included Meniere's disease, Hashimoto's disease, and vitiligo. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included calcium (MANUFACTURER UNKNOWN), levothyroxine sodium (LEVOXYL), melatonin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Feb2021 at 16:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient previously took terconazole (TERAZOL) for an unknown indication and experienced fever. Since the vaccination, the patient had not tested for COVID-19. On 17Mar2021 at 20:45, the patient experienced moderate headache and sore arm. The patient did not receive treatment for the reported events. The clinical outcome of the events moderate headache and sore arm were recovered on an unspecified date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
44 2021-06-16 pain in extremity patient experienced Covid-19; feeling ill; arm soreness; COVID-19; This is a solicited report from a... Read more
patient experienced Covid-19; feeling ill; arm soreness; COVID-19; This is a solicited report from a Non-Clinical-Study (Facilitated Collect) based on information received by Pfizer from via AbbVie (manufacturer control number: 21K-163-3734456-00): A contactable consumer reported that a 44-year-old female received bnt162b2 (BNT162B2, Solution for injection ) intramuscularly on an unspecified date as single dose for COVID-19 vaccination and adalimumab (HUMIRA, Solution for injection in pre-filled pen) subcutaneously citrate free for psoriatic arthritis and currently discontinued. Medical history reported and concomitant medications were not reported. On unknown dates, the patient experienced feeling ILL and arm soreness. On 14Jan2021, the patient experienced COVID 19. In 2021, the COVID 19 resolved. On an unspecified date patient underwent COVID-19 test with Positive result. The outcome of events COVID-19 was recovered and for remaining events its unknown. The reporters causality for the events of feeling ill, covid 19 and arm soreness with HUMIRA was no reasonable possibility and with BNT162B2 it was not reported. No follow-up attempts possible. No further information expected. Information about lot/batch number has been requested.; Sender's Comments: Based on the known safety profile, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid-19
44 2021-06-16 tingling I received my first vaccine dose in April in my right arm - felt off balance for a few days and had ... Read more
I received my first vaccine dose in April in my right arm - felt off balance for a few days and had a low grade fever the day after. I immediately felt pins and needles in my right side of my body after the shot and this didnt really go away for a week or two but was very slight and not really bothersome. I received my second dose in May, in my left arm. Oddly, felt the same pins and needles on my RIGHT side again. I thought this was immediately odd because I used a different arm. I woke up the next day stiff, unable to comfortably move my neck on the right side for about a week and a half. My right arm has constant pins and needles, my right shoulder is painful 50% of the time, I have wrist problems on my right hand side and loss of some motion of my arm. Mostly muscle pain when I lift my arm up or across my body. Constantly hearing cracking or crackling noises. After not being able to put weight on my knees to walk up stairs I visited my doctor who diagnosed me with arthritis, which has never been an issue previously. She tested me for lyme, lupus and auto immune disorder but all test returned negative results.
44 2021-06-17 cold sweat, feeling cold, feeling hot, flushing shortness of breath; wheezing; hot; flushed; cool; clammy; This is a spontaneous report from a conta... Read more
shortness of breath; wheezing; hot; flushed; cool; clammy; This is a spontaneous report from a contactable nurse received via a sales representative. A 44-years-old female patient received second dose of BNT162B2 (COVID-19 VACCINE-MANUFACTURER UNKNOWN, formulation: Solution for injection, lot number unknown) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation; infliximab (INFLECTRA, formulation: Powder for injection, lot Number: EJ1527; Expiration Date: Nov2024, after 7th infusion (2nd reload), via an unspecified route of administration from an unspecified date, at an unknown dose for an unspecified indication. Medical history ongoing Ankylosis Spond. Concomitant medication included methotrexate (METHOTREXATE) taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), for covid-19 immunisation. It was reported that patient was premedicated with Tylenol and Benadryl, used Humira prior to switching to Inflectra. Patient had received 2nd Covid Vaccination at least two weeks prior. Nurse said it was unknown if it was Pfizer or Moderna, but Pfizer was more commonly available being it came out first. No previous issues with Inflectra until Covid shot, event took place after use of product. On an unspecified date, the patient experienced shortness of breath, wheezing, hot, flushed, cool and clammy. The outcome of reported events was unknown. Information about lot/batch number has been requested.
44 2021-06-17 migraine severe rash head to waist; major migraines; severe swelling in arm, legs and face; severe swelling i... Read more
severe rash head to waist; major migraines; severe swelling in arm, legs and face; severe swelling in arm, legs and face; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration, administered in left arm on 12May2021 09:30 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included allergies to tree nuts, shellfish, and lots of medications, fibromyalgia, small fibre neuropathy, brain lesions, asthma, thrombocytopenia, chronic arthritis, nerve damage in elbows and hands, and complex regional pain syndrome (CRPS). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). The patient previously took the first dose of bnt162b2 on 21Apr2021 10:30 (at the age of 44 years old) in the right arm for COVID-19 immunization and experienced extremely sick, affected neurological, and increased pain in fibro with right arm still not fully better left arm same issues neurological wise. On 12May2021, the patient experienced severe rash head to waist, major migraines, and severe swelling in arm, legs and face. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with prednisone, diphenhydramine (BENADRYL), and epinephrine (epi). Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
44 2021-06-17 pain in extremity Got really tired arm is in alot of pain also had some body aches and nausea
44 2021-06-17 tingling Pt anxious exhibiting tachypnea, diaphoretic, stating that the palm of bilateral hands were tingling... Read more
Pt anxious exhibiting tachypnea, diaphoretic, stating that the palm of bilateral hands were tingling and radiating to her fingers. This writer de-escalated situation with deep breathing, providing reassurance, assessed vital signs, and pulse oximetry. VSS with pulse ox within normal range. Provided pt with cold water and saltines. EMT's already onsite assessing another pt, so they were asked to assess this pt. She was noted to be in NAD by EMT as well with stable VS. EMT left scene with no additional treatment or recommendations for this pt.
44 2021-06-17 tingling Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: pt said the follow... Read more
Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: pt said the following day she felt the side of her face was tingling
44 2021-06-17 tremor After experiencing left supraclavicular lymph node pain for a few days, on 3/8 I woke up with a noti... Read more
After experiencing left supraclavicular lymph node pain for a few days, on 3/8 I woke up with a noticeable goiter and severs left neck/throat pain. Swallowing was painful, and my neck ached only on the left side. I went to an urgent care center after work that day and was told to see my PCP. I was able to see her on 3/10, and had thyroid labs drawn and a thyroid ultrasound. The ultrasound showed two nodules > 3.5mm, one on each side of my thyroid. The left nodule was larger. I went for more labs on 3/17, and within two days I began experiencing tachycardia, tremors, anxiety, agitation, and palpitations. I was referred to an endocrinologist and saw her on 3/24. She prescribed me atenolol, which eliminated my symptoms. On 4/1 I underwent a radioactive nucleotide reuptake exam and was diagnosed with thyroiditis. I took the atenolol for about a month and had more labs drawn, which showed I was now hypothroidotic. I was taken off of the atenolol and started on levothyroxin 50mg qd. After taking that for two months I had repeat labs that were on the high side of normal, and my dose of levothyroxin was increased slightly. I am scheduled for a follow-up thyroid ultrasound in two weeks.
44 2021-06-19 tenderness, pain in extremity No symptoms until approx 2 months after receiving my 2nd shotgun 4/30/21. At first, I noticed sorene... Read more
No symptoms until approx 2 months after receiving my 2nd shotgun 4/30/21. At first, I noticed soreness and stiffness in my left arm. The pain and soreness continued to get worse. Approx a week after my initial symptoms, I was no longer able to lift my left arm. Any attempt to raise my arm would result in great pain and screams. My left shoulder is tender to palpation and hurts like all heck.
44 2021-06-20 pain in extremity jun 30 -31 pain in arm and nauseous did not feel good and Jun 7th my headache started so bad I wen... Read more
jun 30 -31 pain in arm and nauseous did not feel good and Jun 7th my headache started so bad I went to the ER - on jun 1o th -my. I had headache from Jun7th to 13 th. Stabbing pain behind my ears , my blood pressure was up and down, I was nauseous and diarrhea.I had migraine before in 2017 and its took 2days only. This pain was different
44 2021-06-20 tingling Had a cardiac work up for periodic racing heart after vaccine while resting, changing position or ju... Read more
Had a cardiac work up for periodic racing heart after vaccine while resting, changing position or just walking around without doing strenuous activity. The first time I had heart racing and a bit of dizziness was within a half hour of vaccination, it resolved then went away for a few days and comes back randomly since being vaccinated. The episodes of increased resting heart rate and heart racing intensified a week after vaccination along with symptoms of paresthesia, tinnitus, and ear fullness (all previously reported to VAERS and V-Safe) prompting a referral to a cardiologist. The outcome of my cardiac work up was a diagnosis of vaccine induced Postural Orthostatic Tachycardia Syndrome. I also still have on going tinnitus, muscle pains, head pressure, periodic internal vibration, paresthesia, and random bouts of vertigo, but paresthesia, vertigo, and internal vibration have improved since onset. Was tested for COVID when all this started and the test came back negative.
44 2021-06-21 numbness Boil that turned into herpes, face numbness, ear infection, heart palpitations
44 2021-06-21 muscle spasms One week after patient received second dose of COVID 19 vaccine, patient experienced irregular break... Read more
One week after patient received second dose of COVID 19 vaccine, patient experienced irregular break-through spotting and cramping.
44 2021-06-22 migraine, pain in extremity Extreme sore arm starting several hours after shot, migraine that night 6/19, all day 6/19: headache... Read more
Extreme sore arm starting several hours after shot, migraine that night 6/19, all day 6/19: headaches, dizziness, woozy, fatigue, nausea, runny nose, brain fog. All day 6/20: headaches, dizziness, woozy, fatigue, nausea, runny nose, brain fog. All day 6/21: headaches, dizziness, woozy, fatigue, nausea, runny nose, brain fog. All day 6/22: headaches, dizziness, woozy, fatigue, nausea, runny nose, brain fog. All day 6/23: dizziness/woozy/brain fog/runny nose.
44 2021-06-22 muscle spasms Extreme chills, fever, headache, muscle spasms/aches, and gastrointestinal issues. Started approxim... Read more
Extreme chills, fever, headache, muscle spasms/aches, and gastrointestinal issues. Started approximately 16 hrs after injection. Lasted for 18 hrs. Still have pain in arm, but that was nothing compared to the other stuff.
44 2021-06-23 concussion Syncopal episode with resultant head injury and concussion. Following second Pfizer dose given 3/3/2... Read more
Syncopal episode with resultant head injury and concussion. Following second Pfizer dose given 3/3/2021-intermtittent dizzy spells also started 3/5/2021. Dizzy spells initially worsened in frequency and severity over time (peaking at 11 occurrences per day on 4/1/2021), then slowly started getting less frequent and less severe. Dizzy spells currently occur on avg. 1-2 times per week and are very short lasting spells that are much much less severe. Evaluation by PCP during this time has included lab testing, BP and BS monitoring, EKG, brain MRI, Echocardiogram, 24 hour holter monitoring for 30 days and cosyntropin stimulation testing.
44 2021-06-23 hot flush Within 5 minutes of vaccine, a flush of heat came over my face and body, my heart started to race, a... Read more
Within 5 minutes of vaccine, a flush of heat came over my face and body, my heart started to race, and ended up in the emergency room.
44 2021-06-23 throat numbness Approximately 5 minutes after receiving vaccine, patient developed numbness and tingling around her ... Read more
Approximately 5 minutes after receiving vaccine, patient developed numbness and tingling around her mouth, inside her mouth and in her throat. She did feel like it was difficult to swallow due to not being able to feel the inside of her mouth, but denied any swelling. BP was elevated initially to the 170s/90s, SpO2 remained >92 throughout. Lungs were clear on exam, there was no asymmetry to her face and no visible swelling. She was given 50mg IM Benadryl and symptoms improved within 20 min. She was advised to take another 50mg of Benadryl at home and go to ED if symptoms returned. Symptoms did not return, but one day after vaccine did develop mild diarrhea.
44 2021-06-24 weakness Severe muscle aches, chills, pain, arthritis, weakness Pfizer-BioNTech COVID-19 Vaccine EUA
44 2021-06-24 flushing Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Mild
44 2021-06-24 tenderness, burning sensation Tenderness; Extremely swollen and painful Lymph node in armpit of arm that received the injection.; ... Read more
Tenderness; Extremely swollen and painful Lymph node in armpit of arm that received the injection.; Extremely swollen and painful Lymph node in armpit of arm that received the injection.; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection,; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 44-years-old female patient (Non Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 07:30 as single dose for covid-19 immunisation. Medical history included drug hypersensitivity (Penicillin). Patient was allergies to Penicillin and Ceftin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), elderberry [sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]) and zinc (ZINC). On 27Jan2021 the patient experienced extremely swollen and painful Lymph node in armpit of arm that received the injection. Pain and swelling started at the injection site, spread around back of arm into armpit, into the my chest, down towards ribs and into my shoulder blade. Felt like the entire area was burning and almost 2 weeks post injection, I'm still experiencing tenderness and the lymph node is still swollen. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of all the events was recovering. Follow-up attempts are completed. No further information is expected.
44 2021-06-24 tremor Blood pressure was high/blood pressure at the ER was high, around 140 something over 90 something/he... Read more
Blood pressure was high/blood pressure at the ER was high, around 140 something over 90 something/her blood pressure has been all over the place, it has been high; Tachycardia; chronic anxiety order; panic attacks; heart rate was up to 150; overwhelming heavy feeling all over her head; eyes got blurry; her throat felt like it was closing up; got real shaky; This is a spontaneous report from a contactable consumer (Patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot: EJ1685, Expiration Date: 31Mar2021), via intramuscular route of administration, administered in left arm on 08Jan2021 at 17:30 (at the age of 44-year-old) as single dose for preventative at hospital. The patient medical history included none except sinus infection. There were no concomitant medications. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot: EJ1685) via intramuscular route of administration, administered in left arm on 18Dec2020 in the afternoon at around 14:00 for preventative. No additional Vaccines administered on same date of the Pfizer suspect. None aside from first dose of covid vaccine was received prior vaccination within 4 weeks. It was reported that, the patient wanted to report a really bad reaction to the vaccine. She had the first dose the Friday before Christmas. She always gets vaccines and never has a problem. After the first dose she did not feel anything, she did not have any of the normal side effects, she was fine. She is a surgical tech. About 9 or 10 days later, clarifies it was Sunday 27Jan2021 she was fine all day and later that evening, she thinks she was either laying in her bed or getting changed and she experienced an episode which she describes as overwhelming heavy feeling all over her head, her throat felt like it was closing up, not like an asthma feeling. Her eyes got blurry. She has never passed out before or fainted, she just felt like she was at that point and got real shaky. She went to the ER since this episode lasted for a while. Her blood pressure at the ER was high, around 140 something over 90 something. They did a lot of blood work and nothing came back. Her pulse ox was fine. They gave her Benadryl in case she was having an allergic reaction. They did blood work and a chest x-ray to make sure for covid. States everything was fine. Her blood pressure went down while she was there for 6 or 7 hours. She was not admitted to the hospital She was told to follow up with primary for hypertension. She went to her primary doctor a couple of days later and explained that the only thing different was that she got the covid vaccine. Her primary doctor diagnosed her with chronic anxiety order and panic attacks and put her on medication, Paxil 10mg and Klonopin for panic attacks. Her primary doctor did not seem concerned about her blood pressure. She bought a pulse ox and blood pressure cuff since she continued to feel these episodes, it was not constant, but she still continued to feel the episodes. Reports her blood pressure has been all over the place, it has been high. When she was last seen by her primary doctor in Mar her blood pressure was 116/68 and she normally runs low. She exercises and she has never had high blood pressure. When she went to the doctor previously, she normally went in for a sinus infection. She is looking to get information about these episodes she is experiencing. The episodes starts with that heavy feeling on her head, her throat feels like it is closing up, her eyes get blurry and she reports her blood pressure has stayed up. She also has some tachycardia. She decided to go see a cardiologist on her own. She had another bad episode this past Friday and her heart rate was up to 150. The cardiologist had her on a Holter monitor for the weekend. She has O negative blood and does not know if this has something to do with her episodes. She is going to have an echocardiogram and stress test next week. She is still experiencing the episodes. About 10 days after the second dose, she went back to ER where she had the same bad episode it was the same symptoms as reported above. They did not find anything in the bloodwork. States she had no issues prior to getting the vaccine, she did not have any panic attacks. States she had nothing like this before getting the vaccine. She works in the healthcare field and she has had all the mandatory vaccinations and has never had a problem. She was not even nervous about getting the covid vaccine, she forgot that she even got it, it was not even on her mind. She did report the episode to occupation health with her employer. It was suggested for her to get the second vaccine, so she did. She has been sent home a couple of times by her director and her doctor is taking her out of work since her blood pressure is going high. The patient underwent lab tests and procedures which included blood pressure measurement: high, around 140 something over 90 something on an unspecified date, blood test: nothing came back on an unspecified date, chest x-ray: everything was fine on an unspecified date, electrocardiogram ambulatory: unknown results on an unspecified date, heart rate: 150 on an unspecified date, oxygen saturation: pulse ox was fine on an unspecified date. Therapeutic measures were taken as a result events. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
44 2021-06-27 weakness, numbness I am experiencing numbness and weakness in my left arm mostly, and somewhat in my leg and face.
44 2021-06-28 myelitis transverse Patient obtained 1st pfizer vaccine on 4/24/21 and then started having symptoms of cervical transver... Read more
Patient obtained 1st pfizer vaccine on 4/24/21 and then started having symptoms of cervical transverse myelitis on 5/1/21. A 2nd pfizer vaccine was received on 5/15/21. A 1.5T MRI of her cervical spine on 5/18/21 diagnosed cervical transverse myelitis which was confirmed with a 3T MRI cervical spine on 5/18/21. Patient hospitalized on 6/26/21 for IV solumedrol 1 gram daily x 5 days for treatment of cervical transverse myelitis. CSF and additional MRIs obtained.
44 2021-06-28 pain in extremity Pt vaccine reaction Timeline: May 4 11:30am - 2nd Pfizer vaccine received. 6:30pm - Slight ankle p... Read more
Pt vaccine reaction Timeline: May 4 11:30am - 2nd Pfizer vaccine received. 6:30pm - Slight ankle pain with no event or accident. chalked up to turning 45. 9:30pm - Walking is more painful and I'm a little worried but again, turning 45. May 5 AM - Began the day with a now swollen ankle (tennis ball like on the outside), sore greater toe joint and I am pretty sure this is vaccine related. No other reason I can come up with. Too coincidental. Called my doctor and she said the vaccine is creating all kinds of strange reactions, but to watch it and if it gets worse come in. PM - The day goes on and I'm not feeling horribly worse but am pretty concerned if it doesn't get better by tomorrow I'm going in. Walking is painful like nothing I've felt. Not injury pain just overwhelming pain. By bedtime (of course) the pain is constant and cannot get comfortable. My friend is helping me with ice and things and I slept between 11pm - 1am. May 6 1-3am - Walking is now excruciating and I'm really worried now. Luckily Dad was up posting on the family page here and I messaged him that I was going to the ER as soon as my friend wakes up or 7am whichever comes first. In a loving and no BS way he tells me to wake her up now and go. This is not something to wait on. This is one of the few times he has given me direction after hearing my plan. I figured I should listen for once. Woke my friend up and off we go to the ER. 3:30am - Kiss my friend and tell her to go back to bed. This may take a while. Walk slowly into ER. Sloth like, painstakingly. She watches until I'm in the door. They check me in quickly with no waiting. 4:00am - I am led to ER room 9. Doctor on duty comes in and we assess. He asks and the nurse asks several times if I turned it or some kind of incident. I said no and gave him the vaccine timeline praying they keep an open mind and don't send me home. I kept saying I know this is strange and when they even touch my ankle now it's just awful. 4:30 - X-ray, blood draw (a lot). I'm sure they needed to check my BAC, drug screen, etc etc. 5:00am - X-ray is clean, no cracks or breaks. Blood tests are a little wonky. White cell count is high. My D-Dimer (test for possible blood clot) is 2x normal so they think blood clot and order the sonogram. She is on call so will be 30min before she gets here. 5:30am - Sonogram wheels in and she starts. She is tired and not very happy. First person to be a bit dry. She is a little rough and toward the end actually GRABBED my ankle and I screamed and nearly cried. She didn't apologize and was done shortly after. It felt like she was "wasting her time" and I prayed for her because I don't know what she's dealing with in her personal life. 5:45am - Sonogram is clean. ER doc comes in and we talk about next steps. He's called the ortho doc on call. He said he can pull some fluid from the swelling to see what we are looking at and send it to the lab to test. I said do it. 6:00am - The lidocaine usually burns, but this time I don?t even twitch because the pain is already terrible. It numbs part of the ankle so he can stick a needle in my now softball like ankle swelling. What he extracts is disgusting looking. He was hoping it was clear but it is not. Send the sample to the lab.They?ve given me an IV line and administered morphine. I don?t like that initial feeling. My whole body burns for a few seconds. It does help the pain so I deal. 7:00am - Shift change, so ER doc briefs the replacement and Ortho doc who is now in on things. Ortho doc immediately puts me in the OR schedule at 9:30am! He assures me this has no relation to the covid vaccine BUT he wants to be safe and clean the infection out if it indeed is an infection. We wait. 8:30am - I am prepped for surgery and wheeled up to the 2nd floor. I feel like this is not an infection but what do I know. Ortho doc wants those results before he cuts into me. Saved by the lab, there is no infection. Morphine has worn off by now and the surgery nurse doesn?t have the authority to administer. I said so I?m just going to sit here suffering? Over dramatic nurse shows her true colors. Time to wheel back down to the ER room 9 to get some pain relief. 9:00am - They now believe this is a reaction to the vaccine. I am admitted to the hospital and they find me a room. 10:00am - I?m in the room and so hungry, mostly thirsty. They start me on IV fluids and antibiotics. 10mg Prednisone. I guess they?re still not convinced it?s not an infection. I say better safe! At this point I can tell that my left foot, greater toe joint, is more painful than just shoe rubbing. I have aches and pains that are pretty regular, but now I cannot put a sheet or blanket on either of my feet. Throughout the day I am updating family and friends. Trying to rest and wrap my head around what?s happening. The ortho doc has scheduled another OR for 11:00 the next morning. He?s concerned about infection and saving my ankle joint from a lifetime of pain. There?s a possibility of gout as well. He goes above and beyond to talk to experts in the auto immune field and gout. Opening up my ankle would cause more pain, and if it?s not necessary they want to focus on treating this correctly. So I spend the day toughing it out with oxy every 4 hours. No food or drink after midnight. Midday - Second friend came to see me and brought my phone charger. I didn?t realize how tired the oxy was making me so we chatted a bit and then needed to nap. Due to hospital regulations, she was the only person who could come see me for the entirety of my stay. They want me to stay the night no matter what so I just hang out and watch Friends all day, messaging here and there. Napping and bored. Overnight thru morning - About 10pm, the tech for the night, 2nd nurse, tells me I need to take a shower with the special antibacterial soaps. I hobble to the shower that he started for me. The shower actually felt good and relaxing. Just a little relief. The nurse on duty was super fun and sweet. Even at 3am she was in a good mood and we talked about Great Danes and her kids. By morning, I was so thirsty and hungry, but possible surgery prevents me from eating or drinking anything unless I?m taking a pain pill. May 7 9:00am - Dr. MD and Dr. OD come visit and several tests have come back from the lab. I can see results right away in a very cool app called One Chart. This is my new favorite app . Turns out the gout test is negative. They looked for crystals in the joint sample and no crystals were found. Also, final results of infection are negative. So the surgery is called off and they finish my IV antibiotic which was almost empty anyway. At this point my ankle is swelled up all around now and my left foot, greater toe joint is swelled up now. I tell the docs my right knee is starting to have pain and my right thumb. 20mg Prednisone and as the day goes, the pain lessens. Later in the afternoon, they told me it was up to me when I wanted to leave. I could stay another night or head home with some new scripts. I was walking better and the pain seemed under control after not taking any pain meds all morning. 4:30pm - My friend came and picked me up. May 8 30mg Prednisone. 500mg Naproxen 2x daily. Saturday was good to be home. Waking up a couple times in the night with pain, but as the day goes on, it?s better. Swelling doesn?t go away, but the pain isn?t constant. May 9 30mg Prednisone. 500mg Naproxen 2x daily. Feeling much better. Swelling still there, but the pain when lying in bed, walking or just sitting isn?t excruciating. Went to dinner at a friend's house for Mother?s Day. May10 30mg Prednisone. 500mg Naproxen 2x daily. Slept all night till 7:30am. 8:30am - appointment with the Ortho Dr.. I told him my thumb and knee were worsening similar to my ankle shortly after my vaccine. I was hopeful to go back to work the next day. May 11 20mg Prednisone. 500mg Naproxen 2x daily. Unfortunately, tapering off the prednisone made walking painful by the end of the day, I had regressed. the pain and swelling flare up. May 12 Sleeping was pointless. I was up at 3am in pain. Swelling and horrible pain. 7:00am - 20mg Prednisone. 500mg Naproxen 2x daily. My right ankle, thumb and knee were twice as big again and my left foot was flaring up again only this time on the outside of the foot. 8:30am - I began by calling the Ortho doc since he was most familiar and following my case closely. I was waiting for a call back and getting scared they weren?t aware of the seriousness of the situation. 9:00am - Rheumatology called to schedule an appointment for Wednesday May 19, so one week away. I accepted the time slot and felt a bit hopeful. 9:30am - I had a call from an automated patient care robot who I informed I wasn?t improving or the same, but getting worse. A human called me back within 5 minutes and we started to figure out a plan. Dr. nurse called me back quickly and made a 3:00pm appointment. 1:00pm - Dr. called me again. He spoke to the rheumatologist I was to see in a week. They suggested putting me back on a higher dose of prednisone and instructed me to take another 10mg tablet immediately. He said he was writing me a prescription for 40mg prednisone daily, calling it in today and to start tomorrow. Evening - Walking is still terrible and I just go to bed. May 13 4:30am - Still waking up every two hours and at 4:30am in pain I give up and move to the couch. Ice, pillow and continued watching a sitcom again. 7:00am - The RX wasn?t filled yesterday so I take 4-10mg tablets to equal 40mg and I start calling the Dr again to make sure that gets filled today. Mornings are so painful. 3:00pm - Finally they push the RX through and my friend picks it up for me along with a few staples. As the day goes on I feel a little better. Stronger and less pain, but the swelling is still prevalent. 9:00pm - I go to bed and pray I sleep till 6. May 14 3:00am - I wake up in pain. Walking makes me cry. Mornings are the worst. The swelling doesn?t seem to be increasing but the stiffness and constant ache in my ankle, knee, foot and thumb are impossible to ignore. Back to the couch for more sitcom. 7:00am - 40mg Prednisone. 500mg Naproxen 2x daily. Working at the dining table is painful and I try several feet up positions to switch around to. Day through evening - Not much changes but it?s not getting worse. Standing for a short period of time seems like too much. 10:30pm - Bedtime and praying the morning is better. May 15 4:30am - Woke in pain, hobbled to the couch, more sitcom. 7:00am - 40mg Prednisone. 500mg Naproxen 2x daily. 9:30am -Third friend picked me up to go get coffee and I borrowed some compression socks from her. They do make my joints feel more stable so I?m trying those out today and overnight. 9:30pm - Went to bed sore which gives me an impression the morning will be rough. May 16 5:00am - Woke in the worst pain since this all started. I would crawl to the bathroom but my right knee is too sore to put pressure on it as well. 6:00am - 40mg Prednisone. 500mg Naproxen 2x daily. I?m taking the steroid an hour early because I can?t stand the pain. My thumb is swollen the worst it has been. Pain in both feet, right ankle and right knee. And now my shoulders and neck are feeling sore. I?m not sure if this is muscle soreness or swelling starting to happen in this area now. Noon - fatigue, nausea, full body aches. Overall gross feeling. Foggy brain and heavy eyelids. 3:45pm - trying as hard as possible to keep my feet up all day. The fear of not sleeping and waking up unable to walk without pain is overwhelming. Spending the day watching movies with my kids. 6:30pm - trying ibuprofen tonight. 800mg /8hrs. Naproxen doesn?t seem to be doing anything. 8:30pm - Going to bed. 11:30pm - Woke in pain as predicted. Slowly painstakingly hobble to the bathroom and back to bed. May 17 3:00am - As predicted, terrible pain just sitting here. Walking is excruciating. I'm gonna have to go back in for sure. 5:30am - Assessing and making decisions. Left foot swelling is down. The pain when walking feels like my foot is ripping in half. Top outside of my foot and greater toe joint feels like I?ve been stepped on by a horse. Right foot and ankle swelling is down a bit. Feels like I?ve severely sprained several parts of it. All the little joints are struggling in my feet. Right knee swelling is worse. The pain is still bad. Feels like stabbing above my kneecap and possibly dislocated. The right side also has a stabbing pain. Trying to walk is unbearable. Right thumb is the worst it?s been yet. Swollen and painful to touch. Not sure if I will be able to work today since it?s my mouse hand. I can?t hold a pen correctly. 8:00am - Called the dr and left a message to help figure out a pain plan or I?m going to have to return to the ER. Waiting on call back. 10:45am - Dr. is prescribing me a higher dose non narcotic pain killer. Tramadol. Also contacting the rheumatologist I?m seeing Wednesday. Not sure what to do for me until they evaluate me. Not much urgency in that department but he?s trying to push me through. 12:45pm - Dr. called and recommended going to the ER main campus. He is out of his element now and wants rheumatologist to get on this. 1:00 - at ER 1:30pm - blood draw then waiting. 3:30pm - Ortho team and Rheumatologist shows up. Tells me more of what I know. Ortho wants to aspirate my ankle again. This time it hurts bad. Great doctors though. 4:00pm - sounds like they?re admitting me. 5:24pm - waiting for someone to take me to a room. Staying until the pain is managed. Hopefully a day or two. My symptoms are very unusual and atypical is what I keep hearing. Looks like infection, but it?s in multiple joints. Multiple joints make them think of some sort of autoimmune disorder. My pain fluctuations are confusing to them. The prednisone should have taken the swelling down within the first few days. Two weeks later I?m back in the ER. 9:45pm - Made it to the room. May 18 4:30am - Woke in pain and the swelling is still here. You would think that staying off my feet would help but it actually makes things worse it seems. My knee is extra puffy today. Thumb hasn?t gone down at all. 6:15am - Another blood draw. So many fluids have been taken out of me lately. 6:45am - Ortho team came in to check on me. No infection growing. They?re still betting on a rheumatological diagnosis. 10:45am - The swelling intensifies today. No prednisone so they can get accurate blood readings. Just gave me IV toradol which is an anti inflammatory and painkiller. Praying for some relief. 11:30am - Entire team of 8 Drs came to see me today. More and more confirming this is a response from my 2nd covid vaccine. I?m feeling even more confident they will have a plan for me soon. They're loving figuring this out! They're reporting everything and making sure everything is documented. They've not seen such crazy numbers in a blood sample as they have in mine. 2:00pm - Rheumatologist and his team of 3 came up with more testing. They?re going to aspirate my knee and ankle again. This time with a precise sonogram instrument. They?re also ordering an Echocardiogram to make sure my heart valves are healthy. 3:00pm - Another fat needle in my knee AND ankle. Pulled out some fluid that wasn?t blood. Sending it through one more time to test for infection. 5:00pm - Toradol is working for pain control. Also starting me on IV steroids to see if they can get the swelling down. 9:00pm - Feels like the swelling is going down. Will see how it is in the morning. I?m hopeful!! May 19 6:00am - Best sleep I?ve had in 2 weeks. The swelling is down quite a bit. Joint pain is still there but not near as bad. 7:30am - Sonogram scheduled to look at my heart valves at 2:00pm. Ekocardiogram. No food or drink until after. 8:00am - Internal medicine doc gave me a lot of information. They still do not think it's an infection. It?s possible I have an autoimmune disorder It?s possible I have a virus in my heart and blood Most likely this is a reaction to the vaccine. My antibodies deposited in these few random joints and my immune system attacked. My liver enzymes are high which is a sign of autoimmune disorder but they?re not confirming that yet. I?m severely anemic which is another sign my body is fighting something. My entire system is inflamed so that?s another concern. 10:30am - Echocardiogram went well. Just checking my heart to make sure no virus or infection there. 2:00pm - On the dot. Sonogram of my major organs went easily even though I hadn?t eaten and was hangry. 3:30pm - another dose of IV steroids and naproxen. 4:00pm - PT visited to see how I was moving. Having to use a walker to be mobile is quite humbling. 5:00pm - Head Attending Rheumatologist came in to discuss. They are being extra sure no infection because that could cause long term damage. The heart sonogram just makes sure my heart valves aren?t infected and spreading an infection in my blood. The liver enzymes are elevated but he said they are not alarmingly high. They think if I can get the swelling down. Pain managed and confirm there?s no infection I will go home tomorrow. I will most likely need a walker and shower bench in the beginning until I get stronger, swelling goes down and pain is minimal. May 20 6:00am - Another pretty good nights sleep. I know they have a few test results they?re waiting on before sending me home. Hopefully that will be wrapped up today. I am achy this morning in those troubled joints so will take naproxen and see how the morning goes. Swelling seems a little better but it?s hard to tell this early. 7:25am - I?m feeling a lot more clear headed today and more confident about going home. I have a long road of recovery but I?m no stranger to that. 3rd friend brought me native coffee this morning. Perks of your best friend working in the same hospital you?re in. And she brought me clean clothes so she?s my hero of the day. My energy level is better today. 1:00pm - Going home today looks less likely by the conversations with the team here at UNMC. Pray they find what they?re looking for and come up with a solid plan to treat me. 2:45pm - EKG to establish a base line. 3:00pm - new IV port. Steroid IV 4:15pm - Finally get new IV after two attempts. I?m getting really sore without the steroids. 4:45pm - New culture swabs to test for more difficult to diagnose infections. They?ve almost certainly ruled out an autoimmune disorder. That?s huge! Next is rule out infection 237%. After that they call it reactive arthritis which is tough to pinpoint why it?s happening but they will treat it as best they can. 5:00pm - Finally get the steroids. Gonna take a minute to feel better. 9:00pm - Started to feel better and lost the constant dull ache in all the problem joints. My knee feels extra sore tonight so trying to find a comfortable position is tough. May 21 5:45am - Took naproxen 6:30am - Swelling is down more this morning. Still painful walking but not nearly as bad. Praying they have a solution today. 8:00am - Internal Med Dr visited with a sneak peek at their tentative plan. They won?t have the last infection test done for 3 days but they think I should be ready to go home today with a solid medication plan of steroids and naproxen. I will be monitored closely at home and have a plan of action if I have a flare up. Also follow up appointments will be scheduled out to measure progress and communicate with the medical team here. I feel truly blessed to have this team working for a solution to this unique illness. ***also my liver enzymes are back to normal and inflammatory markers are reducing. *** 8:45am - Dr. visited. Basic same story. He said the cultures from yesterday are negative but they want them to ?cook? for a couple more days. 10:30am - Infection team visits with their plan to wait for cultures to grow and treat with antibiotics if needed. 11:30am - Internal Med team visits with the same info. They?d like to get me home today. Waiting for the Rheumatology team to confirm their plan for steroid treatment when I am home. 12:30pm - I put pants on. 1:15pm - Dr. in Rheumatology stopped in and basically repeated the previous team?s comments. 3:15pm - IV steroid and confirmed I?m being discharged today. 3:45pm - Dr. Attending Rheumatologist came to explain what they know and what they don?t know. I don?t have an autoimmune disorder. I don?t have an infection that would need antibiotics. What I have is reactive arthritis which they think is responding to ?a virus.? They will not confirm or deny the COVID-19 vaccine reaction, but several think it?s covid related. Time will tell and I am on a slow road to recovery. Many follow up visits and possibly a definite answer some day. 6:00pm - arrived at home and felt so good to be there. May 22-23 Spent the weekend taking it easy. Had several helpers and food drop offs. Each day is less swelling and better range of motion. I?ll update every couple days just to keep a log of recovery. May 25 6:00am - I don?t want to jinx it but the swelling in my knee is down even more this morning. Left foot is almost pain free. Right ankle looks really good considering. Staying off my feet as much as possible seems to be working plus the steroids. Feeling encouraged. June 2 2:00pm - Followup appointment with Rheumatologist Dr. and the attending. They?re changing my prednisone to 10mg/day for the next couple of months. I go back in August as long as everything keeps getting better and I don?t have any flare ups. June 8 Today has been the best mobility I have had in a very long time. Swelling is down alot. Everyday seems to be better. June 18 Had the best day. Less pain and swelling. I was able to walk normally. June 22 Interesting new swelling and pain in my right palm. Sent pictures to Dr. and talked to him on the phone Friday. Staying on 10mg prednisone for now. June 28 All the affected joints are just sore and hard to move. My right thumb is significantly swollen. And right palm has some swelling.
44 2021-06-29 breast pain This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female pat... Read more
This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: EL3249), via intramuscular route of administration, administered in Arm Left on 28Jan2021 13:30 as 2ND DOSE SINGLE for covid-19 immunisation. Patient didn't received other vaccination with in 4weeks prior to vaccination patient didn't had any illness at the time of vaccination. Medical history reported as gastritis from an unknown date and unknown if ongoing Gastritis, constipation from an unknown date and unknown if ongoing IBS with Constipation, irritable bowel syndrome from an unknown date and unknown if ongoing, abdominal discomfort from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole (PANTOPRAZOLE) taken for abdominal discomfort from an unspecified start date and ongoing; citalopram (CITALOPRAM) taken for abdominal discomfort from an unspecified start date and ongoing; clonazepam (CLONAZEPAM) taken for anxiety from an unspecified start date and ongoing. The patient underwent lab tests and procedures which included blood pressure measurement low on 11Feb2021, blood prolactin 62.1 ng/ml on 27Jan2021, body temperature 103 on spiked to 101 on 28Jan2021, then went up to about 103 for the next few days. States that it has improved but has levelled out to be a constant 100-100.5. This morning her temperature was 100.9, body temperature: 101 on 28Jan2021 spiked to 101 on 28Jan2021, then went up to about 103 for the next few days. States that it has improved but has levelled out to be a constant 100-100.5. This morning her temperature was 100.9, chest x-ray: normal on 11Feb2021, electrocardiogram normal on 11Feb2021, sars-cov-2 test: negative on 11Feb2021, sars-cov-2 test: negative on 17Feb2021, scan brain: unknown results on unspecified date. The patient experienced low grade fever on 28Jan2021, headache on 29Jan2021, sweats on 29Jan2021, chills on 29Jan2021, diarrhoea on an unspecified date, body aches on 29Jan2021, breast lactation on Jan2021, low blood pressure on 11Feb2021, breast pain on Jan 2021, dizziness on 11Feb2021, joint pain on 29Jan2021 patient was required to visit the emergency room for the events dizziness and hypotension. Therapeutic measures were taken as a result of, body aches (pain), low blood pressure (hypotension), joint pain (arthralgia). The outcome of the events hyperhidrosis, chills was unknown pyrexia, headache, Arthralgia,pain was recovering, diarrhoea, galactorrhoea,breast pain was not recovered, dizziness and hypotension was recovered on 11 Feb 2021. Follow-up attempts completed. No further information expected.
44 2021-06-29 seizure seizure, altered mental status, febrile
44 2021-06-29 tenderness My underarm swelled up and it was sore for seven days. I had a headache, I felt like I had body ache... Read more
My underarm swelled up and it was sore for seven days. I had a headache, I felt like I had body aches all through my body, extreme fatigue. I slept for almost 24 hours. I felt very achy for all of May. In June, the swelling finally went down but then I was getting constant headaches. I went to the ER on the 23rd and I had a swelling by the nape of my hairline, near my ear. It was soft and it hurt a lot, anytime it was touched, it caused my head to hurt more. The doctor gave me antibiotics and said it was lymphnode-itis.
44 2021-06-30 discomfort Pt. states On/Off nauseous, fatigued, pain at injection site, 2am groin heaviness/bloated 0-fever
44 2021-06-30 pain in extremity Pain on the arm; Body ache; Itching by the hands and face (lips); Itching face(lips); This is a spon... Read more
Pain on the arm; Body ache; Itching by the hands and face (lips); Itching face(lips); This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Ep7534) via an unspecified route of administration in the left arm on 22Mar2021 at 13:15 pm (at the age of 44-years-old) as a single dose for COVID -19 immunisation. Medical history was not reported. The concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced Pain on the arm, Body ache, Itching by the hands and face (lips). The patient did not receive treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the Pain on the arm, body ache and itching by the hands and face (lips) was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
44 2021-06-30 pain in extremity Patient started after pain in her left feet. Both fee have pain but the left foot is more painful th... Read more
Patient started after pain in her left feet. Both fee have pain but the left foot is more painful then the right. Foot is also swollen.
44 2021-06-30 pain in extremity Menstrual period late by 6 days (I have not been late more than once in the past 5 years) Fever of ... Read more
Menstrual period late by 6 days (I have not been late more than once in the past 5 years) Fever of 101.1 around 24 hr after vaccine. Fever slowly subsided but took a couple days. Achy joints especially in fingers and toes, ankles for a few days after vaccine
44 2021-06-30 tremor She woke up at 4:00am and experienced body tremors. She had a fever that morning of 38.5 C and I adv... Read more
She woke up at 4:00am and experienced body tremors. She had a fever that morning of 38.5 C and I advised to take 2 Tylenol every 6 hours as needed for fever. Early that morning, she also experienced vomiting and it hasn't stopped, so I suggested for her to drink some Pedialyte to rehydrate. She also developed some chest discomfort when she draws in a breath, and I advised her to watch and if the fever does not break or any symptoms do not improve, then to seek immediate medical attention.
44 2021-07-01 numbness, trigeminal neuralgia Trigeminal neuralgia was triggered; some TN pain; Trigeminal neuralgia was triggered; face numbness ... Read more
Trigeminal neuralgia was triggered; some TN pain; Trigeminal neuralgia was triggered; face numbness on the left side (TN side) for 6 days; brain fog; nausea; This is a spontaneous report received from COVAES. A contactable consumer (patient) reported a non-pregnant 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: not reported and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on 16Apr2021 at 16:45 (at the age of 44 years old) as dose 1, single for COVID-19 immunization. Patient's medical history included trigeminal neuralgia (TN) (left side of brain), unruptured brain aneurysm (right side of brain), anemia, and asthma. The patient was reported to have allergies to penicillin, contrast dye, latex, paprika, white wine, and vodka. Concomitant medications included carbamazepine, montelukast sodium (SINGULAR), fluticasone propionate (FLOVENT), fluticasone propionate (FLONASE) and GNC Vit (as reported). The patient previously took erythromycin for an unspecified indication and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since vaccination. On 17Apr2021, the patient stated that her TN was triggered and experienced face numbness on the left side (TN side) for 6 days, brain fog, some TN pain, and nausea. The patient did not receive treatment for the reported events. The events resulted to a visit to the doctor's office. The events were assessed as non-serious, did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient recovered from face numbness on the left side (TN side) was on 23Apr2021 while the outcome of the other events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
44 2021-07-01 nerve pain, facial pain By 5:30pm I became febrile at 101.4 and had severe pain on the left side of my face. When I woke up... Read more
By 5:30pm I became febrile at 101.4 and had severe pain on the left side of my face. When I woke up in the morning, I couldn't open my mouth (trismus). Fever continued throughout Saturday with continued severe facial pain (along the facial nerve and axillary n. pathways). By Sunday, fever had resolved but facial pain and trismus continued. Was seen by primary care doctor on Monday who started me on a prednisone taper. Facial pain has improved but but still significant. I can open my mouth but if pushed I get shooting pains down along my jaw and up along the L side of my face extending caudally past my hairline onto my head.
44 2021-07-01 pain in extremity Painful arm from injection.; This is a spontaneous report from a non-contactable consumer, the patie... Read more
Painful arm from injection.; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6198) via an unspecified route of administration in the right arm on 03Mar2021 at 13:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had a history of allergy to codeine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced painful arm from injection. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with Advil for the event painful arm from injection. The clinical outcome of the event painful arm from injection was resolved on unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
44 2021-07-01 tingling, feeling hot Tingling in my hands. Feels like carpel tunnel and fingers feel hot inside .Adrenaline throughout my... Read more
Tingling in my hands. Feels like carpel tunnel and fingers feel hot inside .Adrenaline throughout my body that i can cant sleep.
44 2021-07-02 weakness Rash in both arms, torso, neck and face; hard time breathing; fast heart beat; weaknesses; flu-like ... Read more
Rash in both arms, torso, neck and face; hard time breathing; fast heart beat; weaknesses; flu-like symptoms; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Not reported), dose 1 via an unspecified route of administration in the right arm on 08 Mar2021 at 17:45 as dose 1, single (at the age of 44years) for COVID-19 immunization at pharmacy or drug Store. Patient's medical history included MCAS (Mast cell activation syndrome), POTS syndrome (postural orthostatic tachycardia syndrome), and had known allergy to medications, food, or other products. The patient's concomitant medications included Fludrocortisone (MANUFACTURER UNKNOWN), Metoprolol (MANUFACTURER UNKNOWN), famotidine (PEPCID), and cetirizine hydrochloride (ZYRTEC); all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. On 12Mar2021 at 10:00, the patient experienced rash in both arms, torso, neck and face, hard time breathing, fast heartbeat, weaknesses, flu-like symptoms. Since the vaccination, the patient has not been tested for COVID-19. Patient visited to doctor or other healthcare professional office/clinic and emergency room/department or urgent care. Patient received treatment with singular, benadryl for reported events. The outcome of the events was not recovering. Information on the lot/batch number has been requested.
44 2021-07-02 difficulty speaking Sore lower throat/trachea on outsidenot really on inside; Hurts whencoughing.; Voice sounds gravel-y... Read more
Sore lower throat/trachea on outsidenot really on inside; Hurts whencoughing.; Voice sounds gravel-y and a little hoarse; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8732) via an unspecified route of administration on left arm on 22Mar2021 at 16:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications included spirolactone 50 mg (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), unspecified multivitamin (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 24Mar2021 at 12:00, the patient had sore lower throat/trachea on outside not really on inside. started at noon and worsened over afternoon. Felt like the patient need to cough. Hurts when coughing. Hurts when press on throat. Voice sounds gravel-y and a little hoarse. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore lower throat/trachea on outside not really on inside, hurts when coughing. and voice sounds gravel-y and a little hoarse was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
44 2021-07-02 face paralysis Soreness of facial muscles at the jaw: Started 6/30/2021 at nighttime. Weakness and pain of facial ... Read more
Soreness of facial muscles at the jaw: Started 6/30/2021 at nighttime. Weakness and pain of facial muscles at the jaw while speaking or eating: Started 7/2/2021 at nighttime. Acute onset of emotional lability: Started 7/3/2021 in morning around 10:00 a.m. I don't believe this adverse effect is due to the bipolar II disorder, as I've been taking all of my medications, including psych meds, as prescribed daily. I have experienced a similar level of intensity of emotional lability, like this current event, when I had occasionally stopped taking my psych meds cold turkey. However, I'm taking my psych meds consistently now. Also, my menstruation is due to start within the next few days, and I tend to be more emotional prior to my period, so that may (or may not) possibly have some sort of effect in combination with the COVID-19 vaccine.
44 2021-07-03 weakness, tingling, electric shock sensation Normal immune reaction: fever, chills, headache Abnormal immune reactions developed immediately incl... Read more
Normal immune reaction: fever, chills, headache Abnormal immune reactions developed immediately including tinnitus in left ear, brain zaps or head rushes constantly throughout the day and night with and without dizziness and tingling and swelling in extremities. This has not resolved six weeks post-vaccine. Developed chest pain, vivid dreams, and head pressure/pain. I've seen an ENT specialist and the Neurologist who are calling these long-haul autoimmune reactions. It feels as if my nervous system is in overdrive and inflamed. It is debilitating and is inhibiting my daily life. I am a healthy 44-year-old woman who was in great health prior to this vaccine.
44 2021-07-04 feeling hot, tremor Shortly after receiving the vaccine during the observation period, patient complained she was not fe... Read more
Shortly after receiving the vaccine during the observation period, patient complained she was not feeling well. Symptoms include dizziness, shaking, nausea, and feeling hot. Patient was provided bottled water. Patient requested EMS response who arrived within 5 to 10 minutes. EMS checked on patient and carried her to emergency room.
44 2021-07-05 weakness Acute onset anemia, depleted B12. Symptoms were dizziness, fatigue, weakness and headache. Symptom... Read more
Acute onset anemia, depleted B12. Symptoms were dizziness, fatigue, weakness and headache. Symptoms started on 5/12/21. Resulted in hospitalization, 2 blood transfusions and multiple tests (colonoscopy, EDG) to determine cause. No cause ever determined.
44 2021-07-05 difficulty speaking, speech disorder, pain in extremity At the time of the vaccine, I had typical symptoms of fatigue and arm soreness. A few weeks later ab... Read more
At the time of the vaccine, I had typical symptoms of fatigue and arm soreness. A few weeks later about mid April, I was getting a hoarse voice. I am a teacher and was attributing to that. The hoarseness became more frequent and my throat became sore and painful and difficult to speak. I have a past history of silent reflux. My sore throat and hoarseness did not improvement and I consulted with a telehealth doctor on 6/26/2021. I was prescribed Pepcid 20mg twice a day. The Pepcid seems to be helping. I am drinking a lot of honey and tea. I do have an appt with ENT on 7/13/2021.
44 2021-07-06 tenderness Swollen lymph node next to the clavicle on the right side. Pain to touch. Swelling.
44 2021-07-07 tremor, feeling cold Eight hours after the second dose of the Pfizer vaccine was administered to me, my temperature shot ... Read more
Eight hours after the second dose of the Pfizer vaccine was administered to me, my temperature shot up from the usual 96.9-97.3 to 103.9. I was violently shaking and freezing with chills. I took Tylenol to reduce the fever and it didn't reduce it under 100. The next day my fever was at 103 before fever reducer, only down to 100 with the fever reducer. Day three my fever was 102. Day four was 101. From day 5 until this instant that I type this complaint my temperature hasn't went under 100. In fact, it seems that six weeks after the second dose of vaccine, 100 is my new normal. I'm sluggish and extremely exhausted. I'm becoming short-tempered and aggravated because I just feel like I am running at about 65% of my normal capability. It's horrible.
44 2021-07-08 weakness Slight fever of 100; Chills; slight headache; Tiredness; Body weakness; This is a spontaneous report... Read more
Slight fever of 100; Chills; slight headache; Tiredness; Body weakness; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3248), in right arm on 24Mar2021 at 13:15 (at the age of 44-year-old), as single dose for COVID-19 immunisation. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3248), in right arm on 03Mar2021 at 15:30 (at the age of 44-year-old), as single dose for COVID-19 immunisation. Medical history of the patient was reported as not applicable. Patient had no known allergies to medications, food or other products. The patient did not receive any other medication within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. It was unsure whether, prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 21:00, the patient experienced slight fever (100), chills, slight headache and body weakness/tiredness. No therapeutic measures were taken for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events slight fever, chills, slight headache and body weakness/tiredness were recovering at the time of report. No follow-up attempts are needed. No further information is expected.
44 2021-07-08 muscle twitching, tingling, tremor, mild one side paralysis, numbness I have dysautonomia, heart rate fluctuations and arrhythmia, low BP, no appetite, severe weight loss... Read more
I have dysautonomia, heart rate fluctuations and arrhythmia, low BP, no appetite, severe weight loss, weakness in left side, sometimes I get it on my right arm as well, my tongue goes numb, and I lose my voice at least one a day. Tremors, internal shaking, muscle twitching, numbness tingling on legs and feet, vertigo, tinnitus, severe burning headaches and vision problems. I'm having GI problems, abnormal bleeding both menses and GI. I'm having food reactions now and I never had. I'm having vascular damage.
44 2021-07-08 tingling, numbness, muscle spasms Symptoms started with severe muscle cramping in calves and progressed to numbness and parasthesias i... Read more
Symptoms started with severe muscle cramping in calves and progressed to numbness and parasthesias in legs, arms, and torso. Muscle weakness and inability to continue workouts followed over weeks. Before my vaccine I was riding my bike 15 miles and running 6 miles. I now find it hard to walk one mile due to muscle cramping and weakness.
44 2021-07-08 seizure breakthrough epileptic seizure after experiencing the expected 24 hours of warned side effects of 'f... Read more
breakthrough epileptic seizure after experiencing the expected 24 hours of warned side effects of 'flu-like symptoms' - intense headache, body ache, nausea/loss of appetite.
44 2021-07-09 tremor Swelling of throat and tongue, racing heart and shaky right arm 1 to 2 minutes after receiving the s... Read more
Swelling of throat and tongue, racing heart and shaky right arm 1 to 2 minutes after receiving the shot. Doctor and Nurse on site monitored me. Doctor checked my heart with stethoscope. RN checked my blood pressure. I had taken zyrtec the night before the shot. The symptoms stopped progressing after about 10 minutes. I felt fine 30 minutes after the shot and went home.
44 2021-07-10 weakness low on energy; pain in the lymph node in the left armpit; fatigue; general body pain; chills; vaccin... Read more
low on energy; pain in the lymph node in the left armpit; fatigue; general body pain; chills; vaccination site pain; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 26Mar2021 at 10:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), quetiapine fumarate (SEROQUEL), clonazepam (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA) and caffeine, paracetamol and ibuprofen (IBUPRO); all taken for unknown indications and from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 03Mar2021 at 08:00 (at the age of 44-years). On 26Mar2021, the patient experienced the event pain at the injection point in the left arm. On 27Mar2021 at 11:00, the patient experienced fatigue, body aches, and chills and on 28Mar, 2021 at 08:00, the patient experienced pain in the lymph node in her left armpit and the patient felt low on energy and bit achy. The persistent pain in the lymph node was the reason, the patient reported the event. Treatment was taken as a result of lymph node pain with ibuprofen 200mg. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events vaccination site pain, fatigue, general body pain, chills, lymph node pain and energy decreased was not recovered. No follow-up attempts possible. No further information expected.
44 2021-07-10 pain in extremity irregular periods; Got period again; Arm was a little sore; This is a spontaneous report from contac... Read more
irregular periods; Got period again; Arm was a little sore; This is a spontaneous report from contactable consumer. This 44-year-old female patient reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0177, Expiry date: 31Aug2021) via an unspecified route of administration into the right arm on 06Jun2021 (at the age of 44-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN, Expiry date: 30Sep2021) via an unspecified route of administration into the right arm on 30Jun2021 at 11 AM as single dose for COVID-19 immunisation. No prior vaccinations within 4 weeks. On an unspecified date, the patient experienced irregular periods. 0n 06Jun2021, her arm was a little sore and on 24Jun2021, she got periods again. Within 4-5 hours after vaccination, the right arm was getting sore, later in the evening there was minor soreness. She knew that the second shot would be worse. She was able to deal with the discomfort through the night. That day, her right arm was visibly pulsating and twitching. She explains that she can move her arm halfway up freely, otherwise if she moves it up any further the pulsating was worse. Pain really was not an issue. She has experienced irregular periods since her first dose of the Pfizer Covid 19 vaccine. She has had two periods in a month since her first dose Jun2021. Referred to HCP for continued evaluation and treatment. She reported that the first dose of the Covid-19 vaccine was totally fine. Later, in the evening before going to bed, her arm was a little sore. It was nothing major and went away the second day. On 01Jul2021, obviously her arm was still sore, but now a throbbing was happening and inquired if that was normal. If she just puts her arm down, her arm was almost pulsating like a heart. The pulsating was not hurting, it was just weird. The reason that she waited a few days before getting the second dose of the Covid-19 vaccine is because she got her period twice in Jun2021. She had her period on 01Jun2021 and then got the shot on 05Jun2021 and her period was over. Then she got her period again in Jun2021 and that never happens to her. She got her period on 24Jun2021 again and said that she was not going to be on her period getting the second Covid-19 shot. Her period completed on 28Jun2021, but she waited until 30Jun2021 to get the second dose of the Covid-19 vaccine. The patient was taking Pfizer Covid-19 vaccine to protect her family. Outcome was unknown for event irregular periods. Outcome was resolved for events arm was a little sore on 07Jun2021 and got period again on 28Jun2021. Caller reported that a couple of hours after receiving the second dose of the Covid-19 vaccine, immediately after 4-5 hours, she felt the shot in her arm. She still has soreness in her arm. With the soreness, it kind of hurts to move her arm but it was nothing excruciating. She could not really lift her arm up high or anything, but it was getting better. Arm was throbbing: It was pulsing even her child can see it and it just started happening and had never seen anything like that. She needed to call somebody because that was just weird. Follow up(01Jul2021): This is a follow up spontaneous report from contactable consumer. This 44- years- old female (Patient) reported for herself which included product details. Additional information has been requested.
44 2021-07-10 pain in extremity Did get a sore arm with her 1st dose; This is a spontaneous report from a contactable consumer (pati... Read more
Did get a sore arm with her 1st dose; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0158) via an unspecified route of administration in left arm on 07Apr2021 at 14:00 (at the age of 44-year-old) as single dose for COVID-19 immunization. Medical history of the patient was not reported. Concomitant medication included multivitamins [besides a multivitamin patient does not take anything on a regular basis and sees the HCP once a year; states she does not get sick often and was pretty healthy, eats well, takes vitamins and has an occasional glass of wine]. Patient previously received flu vaccine for immunization and has soreness in her arm. On an unspecified date in 2021, the patient experienced a sore arm with her 1st dose, the arm soreness was for a couple of days or so and was gone. It was reported that she has no name of the flu vaccine she had a sore arm with and no lot number, expiry date or NDC to provide and states the flu shot tends to cause soreness the same day and then she is fine and the Pfizer COVID19 1st dose she was sore a couple of days but it did not prohibit her from doing anything and was just noticeable. AE's does not require a visit to: Emergency Room, Physician Office. No Prior Vaccinations (within 4 weeks) administered. Outcome of the event was resolved on an unspecified date in 2021. Additional information has been requested.
44 2021-07-11 burning sensation, electric shock sensation, muscle twitching, breast pain Had very bad lymph swelling after the initial dose on day 10. Breast pain and lumps under left arm, ... Read more
Had very bad lymph swelling after the initial dose on day 10. Breast pain and lumps under left arm, vaccine side, running down into my ribs and up into my neck. Random migratory pain in joints along with Muscle twitching, headache over right eye, almost felt like a shingles attack. Increased heart rate, fatigue, anxiety, insomnia. Did not seek medical care as was told that those were normal reactions. Symptoms settled day before second shot on March 23. Felt okay for a week then they started back up again but even more pronounced. Have had armpit, breast, back, rib pain that feel like burning and electrical currents, heart palpitations. Random muscle twitching. Joints have been aching and cracking. Had blood work done for lymes disease in April. Negative. In May saw an obgyn who deemed it vaccine related but could offer no treatment after testing negative to RA, Lupus, Lymes. June 14th presented to urgent care as rib and back pain had intensified. They ran an ecg. Ecg was abnormal and was transferred to ER. June 15 Went to hospital where ekg was again abnormal, lengthened qt and st segments which indicate STEMI but clinically I didn?t present any symptoms. Was referred to cardiologist for heart issues. Still suffering back, rib, underarm pain and breast swelling with sensitivity along with random muscle twitching in various areas multiple times a day. Doctors cannot figure out what is cause and say vaccine related.
44 2021-07-11 muscle spasms, mild one side paralysis, numbness, tingling arm swelled; My armpit swelled to size of abaseball.; I had extreme pain at theinjection site,; My g... Read more
arm swelled; My armpit swelled to size of abaseball.; I had extreme pain at theinjection site,; My groin was also painful to the touch; strange numbing sensation andweakness throughout my left side; strange numbing sensation andweakness throughout my left side; My heart raced for about 10 minutes after shot; weakness and tinglingin my arm to my fingertips; tingling in my arm to my fingertips; felt dizzy; muscle spasms on my left side into my face.; my breasts are super tender; I just feel off; foggy headed; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non- pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6208) via an unspecified route of administration in the left arm on 16Mar2021 at 14:15 (at the age of 44-years-old) as a dose 1, single for COVID-19 immunization. Medical history included Immune thrombocytopenic purpura (ITP), a really insignificant low platelet count disorder. The patient had a broken foot and a touchy stomach but that was not a real health concern. The patient was not tested allergic to anything other than pollen. It was unknown whether, the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications were reported as no. The patient did not receive any other vaccines in four weeks prior to COVID-19 vaccination. Since the vaccination, patient had not been tested for COVID-19. On 16Mar2021 at 14:15, the patient felt heart racing for about 10 minutes after shot. The patient had weakness and tingling in the arm to fingertips. The patient also felt mild dizzy. About 24 hours later on 17Mar2021, the patient noticed arm swelling and armpit was swollen to the size of a baseball. The patient had extreme pain at the injection site radiating down the arm and to the left side of the breast. The patient hated the strange numbing sensation and weakness throughout the left side. The patients groin was also painful to the touch. After a week on an unknown date in Mar2021 the swelling had gone down, but the patient had totally random and uncontrollable muscle spasms on the left side of the face. The shot site continued to hurt and the breasts were super tender. The patient felt off and foggy headed. The patient was unsure about taking the second dose. The patient was scared and did not know what to do and also did not want to not get it. strange numbing sensation and weakness throughout my left side. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the swelling arm, axillary mass were recovering, and the clinical outcome of the events heart racing, weakness in arms, tingling, dizzy, injection site pain, numbness, groin pain, muscle spasms, breast tenderness, feeling down and foggy headed, strange numbing sensation and weakness throughout my left side was not resolved at the time of this report. Amendment (26Mar2021): This follow-up report is being submitted to amend previously reported information: Additional PMH "low platelet count disorder" added. Events Physician office visit ticked. Additional coding of "Weakness left or right side" for event "strange numbing sensation and weakness throughout my left side" added, 1st Vaccine letter for NON-HCP initiated. Follow-up attempts are completed. No further information is expected.
44 2021-07-11 nerve injury, tingling, numbness PATIENT CALLED PHARMACY 7-12-21 TO REPORT HAVING "NERVE DAMAGE" FROM COVID VACCINE. PATIENT STATED S... Read more
PATIENT CALLED PHARMACY 7-12-21 TO REPORT HAVING "NERVE DAMAGE" FROM COVID VACCINE. PATIENT STATED SHE HAD SEEN A DOCTOR WHO ADVISED IT WOULD TAKE 8 MONTHS TO GO AWAY. PATEINT REPORTED NUMBNESS/TINGLING IN ARM. PATIENT STATES THIS HAS BEEN PERSISTENT FOR 2 MONTHS NOW AND IS NOT GOING AWAY.
44 2021-07-12 tingling, cold extremities, numbness Numbing and tingling feeling in left hand My hand felt very cold Pins and needles feeling in my left... Read more
Numbing and tingling feeling in left hand My hand felt very cold Pins and needles feeling in my left hand for 90 minutes
44 2021-07-13 migraine, weakness Right after vaccine I slept for 3 days straight with Massive migraine ( big ball of fire) i need a i... Read more
Right after vaccine I slept for 3 days straight with Massive migraine ( big ball of fire) i need a ice to soothe the pain/ body pain. On Monday afternoon on June 28, 2021, with less severe flu like symptoms , i went to the store and i felt dizzy and loss my balance tilting to the right, neck stiff and lac of reflect. i was in no condition for driving. Wednesday June 30th ,2021, i went to the Urgent care with dizziness/ light head/ body ache. I was diagnoses with vertigo and was giving a couple days off work. ( Meclizine prescript) making me drowsy and upset stomach... feeling worst! I still felt weak, light headed and dizzy, lethargic. on Wednesday July 7, 2021 my primary doctor gave me more days to rest. Im back at work today, still feel off, hard to focus and bit dizzy behind the wheel. fyi..
44 2021-07-13 tingling, numbness Tingling immediately in my feet. It moved into my legs with periods of numbness. Mostly pins and nee... Read more
Tingling immediately in my feet. It moved into my legs with periods of numbness. Mostly pins and needles feeling or as if there were droplets of water. After two weeks, it moved into the right side of my face. Teeth hurt and extreme sinus pressure. Some numbness in tongue. Legs, lower legs and feet and behind knees, continued to have pins and needles sensation for seven weeks. Some small itchy bumps on legs. Also dizziness occurring during the first two weeks after dose one. I have not received dose two. I have delayed it on my own without consultation from doctors.
44 2021-07-14 weakness Approximately 3.5 hrs after the shot, I began to feel slightly nauseous. As I was making my way upst... Read more
Approximately 3.5 hrs after the shot, I began to feel slightly nauseous. As I was making my way upstairs to my bathroom, it became difficult to move as if all my strength was fading. By the time I made it to the bathroom, I was so disoriented that I sat down on the floor. I had this overwhelming sensation go through my entire body that made it impossible to move and I felt like I was going to black out. It was as if all of my nerve endings and muscles were "alive". I don't recall how I made it, but I ended up lying down in my bed on my side. It took me several hours to regain enough strength in my body to get up and move around.
44 2021-07-14 electric shock sensation heart palpitations for hours at a time that come in waves and generally always at night racing heart... Read more
heart palpitations for hours at a time that come in waves and generally always at night racing heart rate sometimes as high at 160 beats per minute tingling / electric sensation in the skin muscle aches in both calve muscles light sweat diarreah fatigue
44 2021-07-15 numbness, tingling Had immediate tingling in left arm, fast heart beat. Lymph nodes swelled very large in neck. Exactl... Read more
Had immediate tingling in left arm, fast heart beat. Lymph nodes swelled very large in neck. Exactly 1 wk later right knee swelled & was unable to bend. By next morning couldn?t feel leg was numb & tingling. Next day broke out in rash all around trunk area.
44 2021-07-16 facial pain, numbness, pain in extremity At 3am I had a horrible pain, I had never felt on the left side, as if went through my chest. A shar... Read more
At 3am I had a horrible pain, I had never felt on the left side, as if went through my chest. A sharp pain that went all over my left arm, neck and face and after, a sharp cramp pain in the abdomen like colic. I took aspirin and had pain for half and hour, later it decreased but I still have mild pain, like when I exercise. Numbness in the face neck shoulder, arm and hand. Today I have an electrocardiogram and Monday with my doctor since being the weekend they do not have consultations.
44 2021-07-16 tingling Patient described "bubbling in chest" relative to her GERD experiences as well as some tingling in b... Read more
Patient described "bubbling in chest" relative to her GERD experiences as well as some tingling in bilateral arms. No dyspnea, diaphoresis, dizziness or chest pain reported.
44 2021-07-16 seizure like phenomena Tachycardia, chest pains, pulsating heart, abnormal blood pressure, seizure type activity, treated w... Read more
Tachycardia, chest pains, pulsating heart, abnormal blood pressure, seizure type activity, treated with the IV at the Emergency Room for approximately 4 hours, then released. Following that the tachycardia has not subsided, pulse over 100 24/7 and chest pains, increased seizure activity.
44 2021-07-17 breast pain, discomfort she couldn't walk, she was on her knees in pain; has problems laying on her left side; pain under he... Read more
she couldn't walk, she was on her knees in pain; has problems laying on her left side; pain under her left breast; pain through her left breast; pain in her left ribcage; pain over her left shoulder; pain in the left side of her neck; pain was excruciating; This is a spontaneous report from a contactable consumer (reported for herself). A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Mar2021 11:00 (at the age of 44-year-old) as single dose for COVID-19 immunisation. The patient had no medical history. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. The patient concomitant medications were not reported. Patient had no prior Vaccinations within 4 weeks. On 30Mar2021, the patient experienced pain under her left breast; pain through her left breast, pain in her left ribcage, pain over her left shoulder, pain in the left side of her neck, pain was excruciating, she could not walk, had problems laying on her left side. On an unspecified date, she was on her knees in pain. She had called to report an allergic reaction to the Covid 19 vaccine. She had to be rushed to the emergency department. Her husband practically dragged her in the emergency room. The emergency room ran several tests. Nothing was found. She received a second dose of Morphine and that did not kill the pain. Then they gave her something stronger that Morphine. Morphine was given in the emergency room. She was supposed to get her second COVID 19 vaccine last Thursday (15Apr2021), but she did not get it. She was still having pain in that area. Even the ball from the ultrasound machine was hurt when it was moved over that area, it was painful. The second medication she received in the emergency room was Dilaudid, it was stronger than Morphine. The Dilaudid helped with her pain. The emergency room doctor tested her for everything, blood clots, everything. The doctor threw his arms up in the air and said he was found nothing wrong. She had a follow up appointment the next day and was given a Medrol dose pack. The Medrol dose pack helped with the pain. She thought that she took the Medrol for 1 or 2 weeks. She heard from someone that if she had to be rushed to the emergency room that she could seek compensation. She was asking for information on this. She read that one of the side effects is muscle pain and was still having pain. The patient underwent lab tests and procedures which included mammogram: unknown results, ultrasound testes: unknown results, x-ray: unknown results on 21Apr2021, blood work: unknown results, CT scan chest: unknown results, EKG: unknown results, x-ray chest: unknown results on 30Mar2021. Therapeutic measures were taken as result of pain under her left breast; pain through her left breast, pain in her left ribcage, pain over her left shoulder, pain in the left side of her neck, pain was excruciating, she could not walk, she was on her knees in pain, had problems laying on her left side. Events resulted in emergency Room visit and physician office visit. Patient received treatment with Morphine, Dilaudid and Medrol for events. The outcome of events pain was excruciating, has problems laying on her left side was unknown and other events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
44 2021-07-17 burning sensation but four months later 31May2021 I woke up at 2 am to a burning arm and red arm; I had a white area w... Read more
but four months later 31May2021 I woke up at 2 am to a burning arm and red arm; I had a white area where shot was given.; About two minutes after injection, my hands and feet started burning and itching.; itching; This is a spontaneous report received from a contactable healthcare professional (herself as patient) reported that a 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 22Feb2021 07:30 (age at the time of vaccination 44-years-old), (Batch/Lot Number: EL9262) in the arm left as a DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included hypothyroidism and allergies: coconut oil; both since from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (Strength: 40 mg), levothyroxine and zoloft. The patient previously took moxifloxacin and avelox and experienced allergies. The patient was not pregnant at time of vaccination. The patient was not requiring Hospitalization Prolonged. The most recent COVID-19 vaccine was administered in the hospital. The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. On 22Feb2021 07:32, it was reported that about two minutes after injection, my hands and feet started burning and itching, itching. On 31May2021 02:00 it was reported that but four months later 31May2021 I woke up at 2 am to a burning arm and red arm and I had a white area where shot was given. The clinical outcome of event extremities burning sensation of and pruritus was recovered on an unknown date in 2021. The outcome of the events erythema and vaccination site pallor was recovered on 01Jun2021.
44 2021-07-17 feeling of body temperature change exhaustion/lowered endurance; sweats lasted for 5 weeks; fever; chills; severe inflammation; asthma ... Read more
exhaustion/lowered endurance; sweats lasted for 5 weeks; fever; chills; severe inflammation; asthma worsen; hot, cold; pain; increased sleep; nightmares; This is a spontaneous report received from a contactable consumer (patient) reported for herself. This 44-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Patient was not pregnancy at time of vaccination. Medical history included lupus, asthma. Known allergies: latex, penicillin. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14May2021 05:00 PM, the patient experienced exhaustion, lowered endurance, fever, chills, severe inflammation, asthma worsen, hot, cold, pain, increased sleep, nightmares, sweats lasted for 5 weeks. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for events included injection. The outcome of events was recovered/resolved with sequel. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
44 2021-07-17 numbness, tingling Numbness and tingling moved up my left arm into the left side of my neck and face. The left side of ... Read more
Numbness and tingling moved up my left arm into the left side of my neck and face. The left side of my face was numb for over an hour.; Tingling moved up my left arm into the left side of my neck and face.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021 at 14:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient previously received erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested with COVID-19. On 29Mar2021 at 14:45 the patient experienced numbness and tingling which moved up her left arm into the left side of neck and face. The left side of face was numb over an hour. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of numbness and tingling was recovered on 29Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
44 2021-07-17 migraine Upper respiratoryinfection, laryngitis.; Fatigue; Sore throat; Severe migraine; Slight cough; This i... Read more
Upper respiratoryinfection, laryngitis.; Fatigue; Sore throat; Severe migraine; Slight cough; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 07:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included heart murmur, pituitary adenoma, hearing impaired and exercise induced asthma. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 13:00, the patient experienced severe migraine and slight cough. On 28Mar2021, the patient experienced cough, sore throat, fatigue and on 31Mar2021, the patient experienced upper respiratory infection, laryngitis. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient received unspecified antibiotics, steroids and inhaler as a treatment for the events. The clinical outcome of the event migraine, cough, sore throat, fatigue and upper respiratory infection, laryngitis were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
44 2021-07-17 pain in extremity, muscle twitching right arm is visibly pulsating and twitching; Arm is throbbing; right arm was getting sore; This is ... Read more
right arm is visibly pulsating and twitching; Arm is throbbing; right arm was getting sore; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0217 and Expiration Date: 30Sep2021), via an unknown route of administration, administered in right arm on 30Jun2021 at 11:00 (at the age of 44-years-old) as dose 2, single for covid-19 immunisation. The patient has no medical history. Patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 via an unknown route of administration in right arm on 06Jun2021 (at the age of 44-years-old) (Lot number: EW0177 and Expiration date: 31Aug2021) and got period again and arm was a little sore. Prior vaccination, patient has not received any other vaccine within 4 weeks. Patient has no family history relevant to adverse event. On 30Jun2021, the patient reported that within 4-5 hours after vaccination the right arm was getting sore, later in the evening there was minor soreness. She was knowing that the second shot would be worse. She reported that with the soreness, it kind of hurts to move her arm but it's nothing excruciating. She cannot really lift her arm up high or anything, but its getting better. She was able to deal with the discomfort through the night. On 01Jul2021, she reported that her arm was throbbing. At time of call on 01Jul2021, she had her arm and its totally relaxed. She reported that her arm was pulsing and it just started happening. She said that her right arm was visibly pulsating and twitching even her child can see it. She had never seen anything like that. Her daughter stated that her arm was pulsating almost as fast as she is blinking. She explained that she can move her arm halfway up "freely", otherwise if she moves it up any further the pulsating was worse. She said that pain really was not an issue. Emergency room visit was not required for adverse event. Outcome of event right arm was getting sore was recovering and outcome of other events was unknown.
44 2021-07-17 pain in extremity Pain in arm I received vaccine. Arm felt sore for about 2 days.; This is a spontaneous report from a... Read more
Pain in arm I received vaccine. Arm felt sore for about 2 days.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the arm on 25Mar2021 at 11:00 (at the age of 44-years-old) as a single dose for Covid-19 immunisation. Medical history and concomitant medication was reported as no. The patient was allergic to peanuts. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19.The patient experienced pain in vaccinated arm on 25Mar2021, and arm felt sore for about 2 days. The patient had not received any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the pain in arm was resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
44 2021-07-17 pain in extremity Humira not working well; chills; Muscle pain; pain in arm; Inflammation; big boils in underarms/on t... Read more
Humira not working well; chills; Muscle pain; pain in arm; Inflammation; big boils in underarms/on thighs; big boils in underarms/on thighs; Abscess; This is a spontaneous report received from a contactable consumer (patient) based on the information received by Pfizer. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) intramuscularly on 02Mar2021 (Batch/Lot number: EN6202) as single dose and received second dose intramuscularly on 23Mar2021 (Batch/Lot number: ER2613) as single dose for Covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported), subcutaneous from 17Jul2020 to 05Mar2021, at 40 mg, weekly (40 mg, 1 in 1 week) for Hidradenitis Suppurativa. Age at vaccination was 44-year-old. The patient's medical history included breast abscess removal from 12Jun2020, no tobacco use, abstains from alcohol, iodine allergy manifested by anaphylaxis, endometriosis from Jun2020, supplements. Concomitant medications included tranexamic acid (TRANEXAMIC ACID) for endometriosis, tocopherol as supplements and acetylcysteine/ascorbic acid/bromelains/drosera spp./echinacea spp. as supplements. The patient previously took iodine for unknown indication. On an unspecified date, the patient experienced Humira not working well. On an unspecified date in Feb2021, inflammation, big boils in underarms/on thighs and abscess. On 02Mar2021, pain in arm. On 23Mar2021, chills, muscle pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Duration of the events chills, pain in arm was four days. Outcome of chills, muscle pain was recovered on 27Mar2021, pain in arm was recovered on 04Mar2021, Humira not working well was unknown and other events were not recovered. Causality per reporter (drug/vaccine): chills (probable), inflammation (not related), boil (not related), abscess (not related), pain in arm (probable), muscle pain (probable), lack of drug effect (not reported). No follow up attempts are possible. No further information is expected.
44 2021-07-17 tension headache Temporal artery was protruding from sudden, painful, tension headache-leading to emergency room visi... Read more
Temporal artery was protruding from sudden, painful, tension headache-leading to emergency room visit, >3" diameter enlarged gland in armpit, muscle/joint pain, fatigue (ongoing)
44 2021-07-18 weakness Low to zero energy. Low body temperature under 93 Sweating with little activity Still going on
44 2021-07-18 bell's palsy, facial paralysis I woke up on June 4 to the right side of my face being paralyzed. I went to the ED to be told it was... Read more
I woke up on June 4 to the right side of my face being paralyzed. I went to the ED to be told it was Bell?s Palsy. A coworker?s Priest also had the Pfizer vaccine in March and got Bell?s Palsy around the same time I did.
44 2021-07-18 bell's palsy Bell?s palsy
44 2021-07-18 feeling hot, flushing 11:00 complained of being lightheaded; flushed; hot; heart pounding. 11:15 symptoms eased. 11:20 lig... Read more
11:00 complained of being lightheaded; flushed; hot; heart pounding. 11:15 symptoms eased. 11:20 lightheaded again. 11:30 back to baseline.
44 2021-07-18 numbness, pain in extremity A little over a week after my second dose, I developed very sharp pain shooting down my left arm and... Read more
A little over a week after my second dose, I developed very sharp pain shooting down my left arm and on my shoulder and chest area. My hand falls asleep regularly. I went to the urgent care just to ensure it wasn't heart related and I was assured it was not and the doctor recommended I see a Neurologist. I have an appointment, however I cannot be seen until 8/9/2021 because I am a new patient. So for now I am struggling with how to function every day with this pain and numbness.
44 2021-07-19 pain in extremity, facial pain, muscle spasms, nerve pain Several hours after my second dose of the Pfizer Covid-19 vaccine, I was lying in bed, flat on my ba... Read more
Several hours after my second dose of the Pfizer Covid-19 vaccine, I was lying in bed, flat on my back, winding down for sleep when, suddenly, my right leg was seized by sudden nerve pain in my calf, simultaneous with severe muscle cramping in my quadricep. I also started experiencing sharp nerve "zaps" throughout my entire body--arms, legs, hands, feet, and face primarily. It took several days for the nerve pains to cease, but, two months later, I still have the nerve pains occurring in my face. I think that the facial pain is related to a prior condition of post-herpetic neuralgia from the cold sore virus (HSV1), even though I hadn't had an outbreak in several months before getting the second dose. The other symptoms, though, including the muscle cramping and severe stiffness, as well as the shooting nerve pain in my limbs, were all brand new, beginning for the first time in the hours after my second Pfizer vaccine. For the next one-to-two weeks after my second dose, my right leg and, to some extent, the left leg, had severe, frightening stiffness that I had never experienced in my life. It was even a little difficult to walk, and walking slowly exacerbated the stiffness. I had NOT been exercising in the days before these symptoms began. The only new activity in my life had been that I'd gotten the Pfizer vaccine, so I went to my primary physician to report my symptoms a few days after they began, and she was concerned. She suggested that I stretch my muscles regularly, which I tried, and it made absolutely zero impact or improvement in my muscular stiffness. I just had to wait for the symptoms to subside on their own, which, thankfully, occurred. I firmly believe that the Pfizer vaccine caused the stiffness, cramping, and nerve pain, and I truly hope that a booster shot is not needed in the future because I would think pretty hard about whether to get it. I would worry about developing permanent nerve and muscular problems as a results of a third dose.
44 2021-07-19 pain in extremity Shoulder pain, body aches and pain, and right leg was unable to walk
44 2021-07-19 tremor A few palpitations after first shot. But that subsided. Quivers and tremors and pulsation through bo... Read more
A few palpitations after first shot. But that subsided. Quivers and tremors and pulsation through body began within last week of April/first week of May. Moves around body. It seems to improve some, There?s slight trembling and vibration and light stinging feeling near eyes and in fingers.
44 2021-07-20 facial pain significant swelling underneath both eyes; significant swelling of cheeks; face aches; This is a spo... Read more
significant swelling underneath both eyes; significant swelling of cheeks; face aches; This is a spontaneous report from a contactable healthcare professional, the patient. A 44-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included facial filler which was done on Nov2020, COVID-19 and known allergic to sulfa drugs. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 19:00, the patient experienced face aches. On 19Mar2021, the patient woke up with significant swelling under both eyes and cheeks. The patient was nervous about second dose which was scheduled on 04Aug2021. The adverse events did not result in doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. Therapeutic measures were taken as a result of adverse events included BENADRYL and CLARITIN for over a week and the reactions were slowly subsided. The clinical outcomes of the events face aches, swelling underneath both eyes and significant swelling of cheeks were resolved with sequelae on an unspecified date of Mar2021. No follow-up attempts are needed. No further information is expected.
44 2021-07-20 pain in extremity caused her back to be in so much pain that she still can't walk 4 days later; still can't walk 4 day... Read more
caused her back to be in so much pain that she still can't walk 4 days later; still can't walk 4 days later; depression was ten times worse than it was before the second vaccination; feeling like sick; 101 fever for two days; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; pain and swelling under her arms and at the injection site; Headache pounding; nausea; fatigue; swollen gums; can't eat; I'm in very bad shape; crying; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 27Mar2021 at 12:00 (at 44 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included bipolar, asthma, hypothyroidism, and depression; all from unspecified date. The patient had no known allergies. Concomitant medications included quetiapine fumarate (SEROQUEL), lurasidone hydrochloride (LATUDA), clonazepam (KLONOPIN), lithium, and levothyroxine sodium (LEVOTHYROXIN); all from unspecified date for unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 06Mar2021 at 13:15 (at 43 years old) as single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that after her second shot (27Mar2021 at 12:00), in the middle of the night, the patient woke up feeling like sick like someone hit her with a truck. A 101 fever for two days, pain and swelling under her arms and at the injection site. Headache pounding, nausea, fatigue, all of a sudden it caused her back to be in so much pain that she still can't walk 4 days later, swollen gums, can't eat, her depression was ten times worse than it was before the second vaccination. The patient stated she was in very bad shape since this happened on 28Mar2021 (Sunday). The patient also added "I beg you to study the effects of this injection on people with a mental illness. I'm still crying." The start date of the event was on 28Mar2021 at 04:00. The events caused her back to be in so much pain that she still can't walk 4 days later, still can't walk 4 days later, and depression was ten times worse than it was before the second vaccination were considered medically significant. All events resulted in physician office visit. No treatment received for the events. Outcome of crying and still can't walk 4 days later was not recovered, while the rest of the events was recovered with sequelae on unspecified date in Mar2021. Information on batch/lot number has been requested.
44 2021-07-21 pain in extremity Sore arm; Moderate headache; This is a spontaneous report from a non-contactable consumer, the patie... Read more
Sore arm; Moderate headache; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 12:30(at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Patient received other medication within 2 weeks which included birth control pills (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. Patient did not report any allergy to food, medications or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Mar2021 at 10:15(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 at 03:00, the patient experienced sore arm and moderate headache. Therapeutic measures were taken as a result of events and included treatment with ibuprofen (MANUFACTURER UNKNOWN) started on unknown date. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm and moderate headache was recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
44 2021-07-22 hot flush, numbness Feeling of slight numbness of left side where injection was given-Diarrhea started about 45 mnts aft... Read more
Feeling of slight numbness of left side where injection was given-Diarrhea started about 45 mnts after vaccine - numbness of lower extremities for a few seconds that has happened on two different occasions, late afternoon same day of vaccine and a few weeks after - dizzy/off balance like feeling of the head that is still ongoing but not as frequent - joint pain day of vaccine with body chills, hot flashes, body aches, exhausted, headache that was frequent after vaccine day, fever
44 2021-07-22 numbness, migraine Petechia; Severe migraine; Numbness in the right leg; the site where the shot was done was red and t... Read more
Petechia; Severe migraine; Numbness in the right leg; the site where the shot was done was red and tender; the site where the shot was done was red and tender; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 at 07:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included heartburn. Concomitant medications included unspecified birth control medication, multivitamin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) and influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02Apr2021 at 08:00 (reported as of today), the site where the shot was done was red and tender. She had a severe migraine on Friday and also had numbness in the right leg. She had petechia and those spots had increased. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events the site where the shot was done is red and tender, severe migraine, numbness in the right leg and petechia. The clinical outcome of the events the site where the shot was done is red and tender, severe migraine, numbness in the right leg and petechia were resolving at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
44 2021-07-25 weakness, tingling, muscle spasms, numbness I told nurse my arm was tingling right through to my fingers and it really didn?t feel right. Nurse ... Read more
I told nurse my arm was tingling right through to my fingers and it really didn?t feel right. Nurse informed me to relax there are common symptoms but it will go away. After 15 minutes sitting Dow I went to nurse again and told her the tingling did not go away she restated and told me I was free to go. I returned to work. Tingling continued the entire time there was numbness as well. My chest began to tighten my head hurt and then I started sneezing and rubbing my watery eyes. I told the pharmacist where I worked and was informed these are normal symptoms and they should go away in one day. My sinus began to pain me and constant nasal drip and coughing and sneezing started. I was sent home from work because of this coughing and nasal drainage and muscle tightness and soreness. My temperature was not high. My throat was also sore and felt it was closing up and I had shortness of breath walking up stairs or from parking lot to job (short distance). Thereafter, I was so weak and fatigued and without sleep due to constant coughing nasal drainage I took Tylenol severe sinus, occilococcinum, Sudafed, Motrin, and nothing seemed to help. I did not take meds all at once I did one drug one day another drug the following day etc. my symptoms grew increasingly worse and nothing helped. Sunday I went to ER and explained my symptoms and the doctor there told me he Could not tell me what?s wrong or why it was happening and that what he witnessed looked like a anxiety attack. All my muscles spasm and tightened to the point they seized up completely and I was unable to move. It was uncontrollable muscle spasm and they stayed that way for over an hour. I was given versed and my muscles finally began to normalize or relax after 5-7 minutes.
44 2021-07-25 pain in extremity left hand pain , I had body pain , hand was heavy , limp nods on both of my shoulders just below my... Read more
left hand pain , I had body pain , hand was heavy , limp nods on both of my shoulders just below my ears (on the collar bone) , heavy overflowing Menstrual cycle , lump in my left breast. headach
44 2021-07-25 tingling, numbness Numbness of left side of the face and tingling sensation from time to time (various times during the... Read more
Numbness of left side of the face and tingling sensation from time to time (various times during the day).
44 2021-07-25 seizure, inability to speak, tingling Patient received 1st dose at ~9am on 7/20/21, Was very dizzy and nauseated, she states her lips, toe... Read more
Patient received 1st dose at ~9am on 7/20/21, Was very dizzy and nauseated, she states her lips, toes and fingers felt very tingly within hours of vaccine. She then stated that she got very disoriented and couldn't speak and then had a seizure. EMS was called and she was taken to the hospital and was admitted for observation, I made F/U call and patient seemed to be doing well, but was still admitted and stated she was told she would be there a couple of days. She was at work after receiving the vaccine when these events took place.
44 2021-07-26 slurring, throat numbness After her first dose at another facility she said her throat felt numb but she was okay and advised ... Read more
After her first dose at another facility she said her throat felt numb but she was okay and advised by her physician to get the second dose. Within 5 minutes of receiving her second dose she felt like her throat was numb and tight. She did feel like her throat may close but not having difficulty breathing at that moment. Her speech did sound slurred (like after having mouth numbed). Due to history of anaphylactic reactions to certain foods, clinics epipen was used immediately in her right thigh. Immediately symptoms began to improve. Patient given 50mg bendryl liquid once able to swallow. VS monitored continuously and stable. Patient transported POV by her husband to the hospital that is 1 mi away. She arrived safely and was monitored further there.
44 2021-07-27 inability to speak Presented to COVID Vaccine Clinic with known history of allergic reaction to MSO4-stated it was anap... Read more
Presented to COVID Vaccine Clinic with known history of allergic reaction to MSO4-stated it was anaphylactic in nature, happened while in the hospital. Approx 10 min after vaccine administration patient began to complain of being unable to swallow, unable to take a breath, unable to speak. Treated with EpiPen x 1 with improvement. Taken via EMS to local hospital where she was observed/monitored and discharged home.
44 2021-07-27 migraine, pain in extremity She had an egg on her arm, that also had a red rash; Swollen lymph nodes and armpit; Lymph node pain... Read more
She had an egg on her arm, that also had a red rash; Swollen lymph nodes and armpit; Lymph node pain, under armpit; Tiredness; Bad migraine, after first vaccine.; Soreness left arm injection site: described as red dot and small swelling at injection site, with warmth radiating from the site, after first vaccine; Soreness in her arm; Red rash at injection site/red dot at the injection site; Small swelling at injection site; Warmth radiating from the site; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/Lot number (Lot: caller reports EW, then caller thinks it is zero, then reports the numbers 167) was not reported; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 at 10:00 as DOSE 1 (Patient Age at Time of Vaccination: 44 years), SINGLE for covid-19 immunisation (last Thursday the patient got her first shot). Medical history included multiple allergies from Oct2000 and ongoing (Caller states the allergies are unspecified for report, and provides no specific details for the medications, or NDC, Lot, or expiration dates), back injury from Oct2000 to an unknown date (caller states the allergies started after back injury Oct2000). The patient's concomitant medications were not reported. Caller states that she is disabled, but does not want to report her medications. Caller states she did not panic, and go to the emergency room, unless she cannot breath, which has happened with some of her other allergies. The patient experienced soreness left arm injection site: described as red dot and small swelling at injection site, with warmth radiating from the site, after first vaccine on 13May2021 at 17:00 (she got the shot at 10 am, and by 5 pm, her arm soreness began), bad migraine, after first vaccine on 15May2021, tiredness on 16May2021 (Caller states that by Saturday or Sunday, she had bad migraines, and she was tired), swollen lymph nodes and armpit on 17May2021, red rash at injection site/red dot at the injection site on 13May2021, small swelling at injection site on 13May2021, warmth radiating from the site on 13May2021, lymph node pain, under armpit on 17May2021 (Caller states on Monday, Tuesday and Wednesday, she had lymph node and under her armpit), soreness in her arm on 13May2021, she had an egg on her arm, that also had a red rash on 21May2021 (Caller states last night she had an egg on her arm, that also had a red rash, Caller states the rash is spreading up to her shoulder/ caller states she initially noticed this event when rubbing her hand on her arm, Caller states, specifically, the rash, it looks like a huge bruise, around the size of a half dollar). Patient was asking how long does the symptoms last and will there be delayed presentation of symptoms. Caller states she is severely allergic to a lot of medications and she didn't want to have to go the emergency room, Caller states these events are making her hesitate to get the second shot and the caller also states she has read about delayed reactions and that makes her hesitant to get the second shot. Caller states for normalcy, and to have the ability to travel and not wear a mask. Caller states she is single and has been isolating, and she would like to interact with other people, for meet ups and group events. Outcome of the events Soreness in her arm was recovered on 16MAY2021, Bad migraine, after first vaccine, Tiredness was recovered on 17MAY2021, Swollen lymph nodes, Lymph node pain, under armpit and armpit was recovered on 19MAY2021, Soreness left arm injection site: described as red dot and small swelling at injection site, with warmth radiating from the site, after first vaccine, Red rash at injection site/red dot at the injection site, Small swelling at injection site, Warmth radiating from the site and She had an egg on her arm, that also had a red rash was Not recovered. Follow-up (21May2021): This is a follow up-spontaneous report from a contactable consumer. Information on lot/batch number was not available. Additional information has been requested.
44 2021-07-27 pain in extremity Chills; Right finger pain; Wrist pain; Headache; This is a spontaneous report from a non-contactable... Read more
Chills; Right finger pain; Wrist pain; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730 7/21) via an unspecified route of administration in the left arm on 03Apr2021 at 10:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food or other products. Concomitant medications included levocetirizine dihydrochloride (XYZAL), from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL 9266) via an unspecified route of administration in the left arm on 09Mar2021 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 21:00, the patient experienced chills, right finger pain, wrist pain and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of chills, right finger pain, wrist pain and headache were recovered on unknown date in Apr2021. No follow-up attempts are possible. No further information is expected.
44 2021-07-28 weakness No strength and weakness in arms. Notable the right arm.; Half dollar sized circles on arms, legs an... Read more
No strength and weakness in arms. Notable the right arm.; Half dollar sized circles on arms, legs and face.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Apr2021 at 11:00 (at the age of 44-year-old), as a single dose for COVID-19 immunisation. Medical history included circulation issues. Concomitant medications included methylphenidate hydrochloride (CONCERTA) and alprazolam (XANAX) started on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021 at 18:30, the patient experienced half dollar sized circles on arms, legs and face; no strength and weakness in arms and was notable in the right arm. The clinical outcome of the event half dollar sized circles on arms, legs and face; no strength and weakness in arms and notable the right arm was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
44 2021-07-29 nerve pain Shingles; She can't even use one of her arms; Muscle aches; Nerve pain; Pain; Swollen; Low platelets... Read more
Shingles; She can't even use one of her arms; Muscle aches; Nerve pain; Pain; Swollen; Low platelets; Body aches; Chills; Got the second dose 2 weeks after the first dose; Could not function correctly; Headache; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, in Left Arm on 03May2021 at 11:30 (at the age of 44-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Left Arm on 19APr2021 at 11:30 as dose 1, single dose for COVID-19 immunization and experienced Could not function correctly, Headaches, Body aches, and chills. On 03May2021, the patient got the second dose 2 weeks after the first dose and experienced Could not function correctly pain , muscle aches, Body aches, swelling, Chills, Pain was all over the body on the right side. on 13May21 patient experienced Shingles, pain, Swollen, Low platelets caller stated that now she can't even use one of her arms. She had muscle aches and her nerves are acting up. She had nerve pain. patient visited physician office for adverse event. The patient underwent lab tests and procedures which included blood test: positive on 23May2021 Positive for shingles, blood test: decreased on 23May2021 low platelets. Therapeutic measures were taken as a result of all the events where she was given an antibiotic and nerve pain medicine. These were Diclofenac 75 mg, Prednisone 20mg, Valacyclovir 1gm and Gabapentin 300mg. The outcome for the events was not recovered. Information on the lot/batch number has been requested. Amendment: (06Jun2021) This follow-up report is being submitted to amend previously reported information: To recode LLT from Loss of personal independence in daily activities to LLT General malaise, to delete LLT off label use. Follow-up (21JUL2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
45 2020-12-31 numbness Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness a... Read more
Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.
45 2020-12-31 pain in extremity 12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 d... Read more
12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 days ago. The site on her left deltoid where she got the shot is warm and read. It also itches. No pain into the rest of left arm. no numbness of tingling at site or distally. no trouble breathing or tingling around mouth/throat. 01/01 - EE notes that her arm was very sore and she had a bad headache. As the days went on, it got redder, hotter, and more swollen. On 12/20, she began to feel bad. On 12/28 while at work, she heard that her supervisor was COVID (+). Throughout the day she felt worse and worse. Was seen at urgent care and COVID was negative. Prescribed Cephalxin and predinose 01/01 -- arm is much better today. Today it is still bruised. She thinks it was bruised previously but that the bruise could not be seen under the redness and swelling
45 2021-01-01 feeling hot Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt... Read more
Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt hot, lips tingling/swollen and chest red. Denies any issues with breathing.
45 2021-01-01 tingling Started with right arm tingling/slight numbness feeling down to my fingertips. Two days my left arm ... Read more
Started with right arm tingling/slight numbness feeling down to my fingertips. Two days my left arm felt the same with slight improvement in my right arm. Later that day, I felt tingling in my left leg down to my toes. I have felt these symptoms every day since, but they have improved in severity, moving from one side to the other at times. This has not affected my activities of daily living, nor my work as a RN.
45 2021-01-02 cold sweat, flushing After the shot I sat down and waited for 15 minutes and about 12 minutes a felt flushed and my pul... Read more
After the shot I sat down and waited for 15 minutes and about 12 minutes a felt flushed and my pulse went night around 119 beats per minute and my blood pressure went high to 150 over 99 .. my sugar jumped to 149 and I got so clammy .. it lasted a good 25 minutes I kept checking my o2 and my pulse finally it went down and I was so tired.. I went home and I was fatigue for 5 days .. I don?t know if I should get the second dose after my heart raced
45 2021-01-02 feeling cold, weakness Dizziness and Weakness, Headache, Aches, Cold feeling, Nausea, generally feeling unwell.
45 2021-01-03 burning sensation 2 Red Area-, itching, burning-the size of a golf ball, the other the size of a quarter- Located at t... Read more
2 Red Area-, itching, burning-the size of a golf ball, the other the size of a quarter- Located at the front of my neck I had vaccine on 12/30/20 at 1:30 pm, and woke up on 01/01/21 at 7am with the red areas.
45 2021-01-03 feeling hot, numbness right arm numbness, sensation of throat constriction and heat in her body
45 2021-01-03 pain in extremity, muscle spasms 24hr extreme malaise (charley horse left calf) left arm pain 24hr temporal headache 24hr
45 2021-01-03 pain in extremity, tingling, numbness, weakness After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm a... Read more
After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm and leg for 20 minutes but neck and face numbness continued 12/25-12/27. Continued with facial numbness on 12/26. Called Occupational Health on 12/28 and stated that she had thigh numbness, no other Covid symptoms. Sent for testing and was negative. On follow up on 12/29, had fatigue, diarrhea and weakness, and on 1/1 still had thigh numbness and extreme fatigue, no diarrhea. By 1/3/21, had fingertip numbness on left hand, pain on her left arm and chest pressure and burning. Went to ER on 1/3 where she had a full workup for myelitis, MRI, C spine, T spine and brain, CBC, CMP, ESR. Treated with toradol and prednisone in ER and discharged. Currently on 1/4 improved muscle weakness but ongoing fatigue taking four day course of prednisone to follow up with PCP. A second dose of the vaccine scheduled on 1/11/21 will be on hold until PCP clearance. Current diagnosis decompensation of raynauds disease due to vaccine reaction.
45 2021-01-03 pain in extremity Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headach... Read more
Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headache is not uncommon for me but the extreme drowsiness is). I slept solid through the night (unusual) and the puppy woke me around 5am. (ususal) I felt that i had a heavy? head. My thoughts seemed clear but my head had a fullness to it. Its difficult to describe. I was not stuffy. I had trouble staying awake, to the point I was nodding off at times I should have been able to stay awake. I did not feel safe to work and felt obligated to call in. I slept solidly for the next 5 hours. Later in the day, my affected arm began to have pain radiate from the injection site to my wrist. (probably not unusual). 600mg of Ibuprofen did not seem to help much. By the time I went to bed last night (24+ hrs after receiving the vaccine) I noticed my axillary nymph nodes were extremely tender to the touch and remain so this morning. The pain in my arm still continues to radiate to my wrist but not as intense.
45 2021-01-03 tingling Tingling of face for a couple hours, starting 2 hours after vaccine, gone by the next day
45 2021-01-03 throat numbness Had an episode of tounge tingling and numb throat. Lasted 30 min, resolved without any treatment.
45 2021-01-04 feeling hot Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness ... Read more
Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness was spreading to left lateral neck and across upper chest. Took 50mg chewable Benadryl and 600mg motrin. All symptoms subsided approximately an hour later.
45 2021-01-04 flushing itchy flushed skin with a rash; itchy flushed skin with a rash; itchy flushed skin with a rash; This... Read more
itchy flushed skin with a rash; itchy flushed skin with a rash; itchy flushed skin with a rash; This is a spontaneous report from a contactable healthcare professional. A 45-year-old female patient received bnt162b2 (BNT162B2; reported as Pfizer-Bio-Tech COVID-19 Vaccine; lot number: EH9899; expiration date: unknown), intramuscular left arm on 16Dec2020 10:45 (also reported as 10:50 AM) at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. It was unknown if the patient has allergies to medications, food, or other products. It was reported that the patient was given vaccine at 10:50 am and 10 minutes after receiving the vaccine individual developed itchy flushed skin with a rash. She was given Benadryl 50 mg IM (intramuscular) in Right arm at 11:00 am. 11:37 am the itchy skin was less intensified, and vitals were stable. The patient went home with her husband. The event was considered as non-serious, was not life-threatening, did not caused/prolonged hospitalization, did not cause congenital anomaly/birth defect and did not resulted to death. The patient received the COVID-19 vaccine in the Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patent had any other medications the patient received within 2 weeks of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination and if the patient been tested for COVID-19 since the vaccination. The outcome of the event itchy skin was recovering while the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
45 2021-01-04 pain in extremity had a severe pain in upper left hip; hurt to lift my left leg up (while taking a step forward); This... Read more
had a severe pain in upper left hip; hurt to lift my left leg up (while taking a step forward); This is a spontaneous report from a contactable nurse (patient). A 45-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular in the left arm on 24Dec2020 08:15AM at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included lyme disease from 2014. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive other vaccines in last four weeks. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 25Dec2020 07:30AM, the patient had a severe pain in upper left hip. It felt like an IT band issue she had before but this time it didn't radiate to her knee like it usually does. She did not have exercise since the morning of the 22nd when she did an upper body weight-lifting session. She took ibuprofen that took the edge off, and she was able to finish her day as a nurse in the Covid ICU. The following morning, she felt fine and went to her other job. She was fine in the morning during her usual drills practicing getting out of the helicopter while on the ground. She sat in one of the seats for about 15 minutes while having a discussion when she started to feel the pain again. She got out of the helicopter and tried to walk around, but it hurt to lift her left leg up (while taking a step forward) in Dec2020. She has never experienced this before. She limped back to the hanger, took ibuprofen 600mg and rested/stretched for an hour. The pain was reduced to a minor and tolerable ache. The outcome of the events was recovering. The report was considered non-serious.
45 2021-01-04 tingling, numbness Face started to tingle then went numb roughly 45-55 minutes after receiving.; Face started to tingle... Read more
Face started to tingle then went numb roughly 45-55 minutes after receiving.; Face started to tingle then went numb roughly 45-55 minutes after receiving.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received bnt162b2 (lot number: EL0140, Pfizer- BioNTech), intramuscularly at arm left, first dose on 23Dec2020 07:45, at single dose, for COVID-19 immunization. Medical history included environmental allergies, iron deficiency anemia, endometriosis, allergies to penicillin, and allergies to preservatives in flu vaccine from an unknown date. The patient is not Pregnant at the time of vaccination. Concomitant medication included ibuprofen, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12), magnesium, all from an unspecified date, for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Age at vaccination is 45 Years old. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced face started to tingle then went numb roughly 45-55 minutes after receiving (reported as from 23Dec2020, 08:30 AM). Not sure if that is an actual reaction but it occurred. The event was reported as non-serious. Therapeutic measures were taken as a result of face started to tingle then went numb roughly 45-55 minutes after receiving, treatment included BENADRYL orally taken. The outcome of the event was recovered in Dec2020.
45 2021-01-04 tingling Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring ... Read more
Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring finger. It went away in 20 plus minutes. Around 11 pm started having metallic taste again and woke up with diarrhea in the middle of the night. Symptoms have not subsided.
45 2021-01-04 tingling Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and rin... Read more
Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and ring finger. Around 11 pm started having metallic taste and cannot get rid of it. Woke up in middle of the night having diarrhea which still having symptoms this morning.
45 2021-01-04 cold extremities 12 hours after the vaccine my right hand was really cold. There was a significant difference in the... Read more
12 hours after the vaccine my right hand was really cold. There was a significant difference in the temperature of the left hand.
45 2021-01-04 tenderness Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the tou... Read more
Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the touch, soreness and tender.
45 2021-01-05 inability to speak Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine... Read more
Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine clinic for her second-dose of the pfizer COVID-19 vaccine. Pharmacist then delivered vaccine. Almost immediately after administration, the patient started showing signs of distress including difficulty speaking, and going in an out of consciousness. Ice packs were placed on the back of patient's neck, and she was given water in order to hopes to stimulate consciousness. At this time, the pharmacist placed a pulse oximeter on her finger to monitor. Her oxygen stats dropped to 75% and heart rate dropped to a value slightly greater to slightly under 30 beats per minute as indicated by the pulse ox blinking at 30. Pharmacist timed the period of bradycardia, after 60 seconds an epinephrine pen 0.3mg was administered to the left lateral thigh. Rapid response code was called and team came 1.5 - 2 minutes after epinephrine administration. Oxygen was given to the patient at the scene where her recorded blood pressure was 94/54 mmHg. She was then transported into the emergency department via wheelchair. Patient stabilized and was discharged back to work approximately an hour after arrival.
45 2021-01-05 flushing [1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative br... Read more
[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative breathing; believed it to be anxiety related until seeing CDC produced list of symptoms from vaccine. [2] Mild soreness, mild redness at injection site: started 4 hours after vaccine, lasted 24-36 hours. [3] Felt feverish and flushed, arthralgia: started approximately 18 hours after vaccine (12/31/2020). "Fever" initially managed with Tylenol 650 mg. Later that evening took naproxen 440 mg to address arthralgia, which lasted about 2 days. No medication taken on 1/1/2021.
45 2021-01-06 weakness, flushing around 1500 Vomited x 1; HTN 190's/ 116-118; flush cheeks bilaterally; dizzy; weak;
45 2021-01-06 burning sensation Burning sensation. Started in left side of neck went to left shoulder then spread out all over body... Read more
Burning sensation. Started in left side of neck went to left shoulder then spread out all over body. Headache and fever
45 2021-01-06 cold sweat CLAMMY SKIN , LABORED BREATHING , DRY COUGH, TREATED WITH BENADRLT . SENT TO ER, PLACED ON DECADRON... Read more
CLAMMY SKIN , LABORED BREATHING , DRY COUGH, TREATED WITH BENADRLT . SENT TO ER, PLACED ON DECADRON.
45 2021-01-06 facial paralysis, tingling Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, starte... Read more
Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, started approximately 10 minutes after receiving vaccine. Reaction resolved with no treatment. Patient developed Bell?s Palsy 2-3 days after vaccine. Currently being treated with high dose steroids and acyclovir.
45 2021-01-06 flushing felt flushed; itch and felt tightness in her throat; itch and felt tightness in her throat; fatigue;... Read more
felt flushed; itch and felt tightness in her throat; itch and felt tightness in her throat; fatigue; arms and legs feel heavy; This is a spontaneous report from a contactable nurse (patient herself). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: Ek5730, expiration date: unknown), via an unspecified route of administration on the left arm on 30Dec2020 at 08:00 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included Hashimotos, Celiac, nonalcoholic fatty liver, and known allergies to gluten, eggs whites and eggs yolks, mustard seed, and penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC), thyroid (NATURE THROID), and an unspecified women's multivitamin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 08:15, also reported as within 10 minutes, the patient felt flushed and at 20 minutes, she started to itch and felt tightness in her throat. The patient left after 30 minutes to go home and take diphenhydramine (BENADRYL). The patient worked at night and slept most of the day except to take BENADRYL and call out from work. Also on 30Dec2020, she noticed fatigue when she woke in the afternoon and her arms and legs felt heavy. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of itch and felt tightness in her throat. She had been on BENADRYL 50 mg every 4-6 hours. The itching and throat tightness remained unchanged. She had used an albuterol inhaler 3 times. The patient did not receive treatment for the other events. The patient was not recovered from the events "felt flushed, itch and felt tightness in her throat, fatigue, and arms and legs feel heavy."
45 2021-01-06 hot flush nausea, hot flashes were noted, pt BP 162/98; Spo2 98%; HR 69. Pt given water and waited for extende... Read more
nausea, hot flashes were noted, pt BP 162/98; Spo2 98%; HR 69. Pt given water and waited for extended period. Pt stated she felt better and was able to ambulate independently. A/O x4
45 2021-01-06 pain in extremity, nerve pain Soon after the vaccination she began having arm pain that lasted for 3 days. That has resolved, but ... Read more
Soon after the vaccination she began having arm pain that lasted for 3 days. That has resolved, but now she is having nerve pain in her right thumb.
45 2021-01-06 tingling, night sweats Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and ti... Read more
Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and tingling right hand.
45 2021-01-06 tingling I had some aches and pains. I was tired the next morning. I started having chills and became dizzy. ... Read more
I had some aches and pains. I was tired the next morning. I started having chills and became dizzy. My hands started to tingle and remained that way for three days. I developed a cough, sore throat, and fever. The fatigue was really bad for a few days.
45 2021-01-06 tremor At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my... Read more
At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my elbows but knees and hips as well. Then my neck started really hurting. I got a headache. Nausea and powerful chills that made my whole body violently shake. My core temperature Dropped to below 96, high 95s. Over a period of two hours I have stabilized my body temperature, the shaking has stopped. However the headache and muscle aches persist. No respiratory symptoms have developed. I feel as if I am recovering, over a period of about four hours.
45 2021-01-07 cold sweat, flushing I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitati... Read more
I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitations I was told my skin was clammy then I had another episode I was taken to ER and decardron was given. I was observed in ER for few hours . Since that day I have heart palpitations every day along with chest pain sometimes I am not able to wean off steroids I also had diarrhea on 1/3 that lasted few days . These side effects are very scary every day heart palpitations I feel my heart would stop
45 2021-01-07 discomfort, flushing After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by ... Read more
After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by a metallic taste. Elevated BP noted. Pt denies SOB and is without rash or angioedema. Pt brough to emergency dept where she reported feeling flushed, nausea, and headache. Given Zofran 4mg ODT and Tylenol 650 mg po. Pt d/c after 2 hours and advised to f/u w/ PCP as needed.
45 2021-01-07 discomfort, tremor Fever, Headache, Shaking Chills, Discomfort in the body. I am taking Panadol every four hours.
45 2021-01-07 facial pain Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - a... Read more
Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; This is a spontaneous report from a contactable physician (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (arm left), on 19Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received facial filler Restylane, which was injected in Sep2019. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within two to four weeks prior to COVID vaccination. On 22Dec2020, approximately 3 days after vaccination, patient noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas. There was minimal erythema and tenderness only on palpation. The events resolved approximately 3-4 days later (unspecified date in Dec2020). The events did not require intervention/treatment. Outcome of the events was recovered. Information on the lot/batch number has been requested.
45 2021-01-07 hot flush typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting... Read more
typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.
45 2021-01-07 muscle spasms Headache, Diarrhea with cramping
45 2021-01-07 pain in extremity Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after inject... Read more
Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection. Rapid Response called @1721, patient monitored.
45 2021-01-07 pain in extremity Diarrhea; Headache; Arm soreness; This is a spontaneous report from a contactable nurse. This nurse ... Read more
Diarrhea; Headache; Arm soreness; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 3rd of 6 reports. A 45-year-old female patient received a single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) on 29Dec2020 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, on 29Dec2020, the patient had arm soreness and it lasted a few hours. The patient took Tylenol and was fine. She also developed diarrhea and headache, and her symptoms hit her all of a sudden late afternoon on 04Jan2021. No treatment was received. She woke up in the morning of 05Jan2021 and it was all gone. She had a COVID test on 05Jan2021 and it was negative. The patient recovered from the arm soreness on 29Dec2020 and recovered from diarrhea and vomiting on 05Jan2021. The events were considered related to the vaccine. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
45 2021-01-07 pain in extremity I got the vaccine on 12/18/20 on my left arm and on 12/28/20, 10 days after I started to have pain o... Read more
I got the vaccine on 12/18/20 on my left arm and on 12/28/20, 10 days after I started to have pain on my upper left arm and the next day the pain went to my armpit, back and forth from my upper left arm to my armpit and this went on for at least 5 days. On 01/02/21, 15 days after I notice red bumps on my upper left arm and as days went on red bumps show in my armpit, left back, and chest. The pain went from sharp to burning. On 01/06/21 I got the 2nd dose of the vaccine and I told the injection person about the red bumps. I told him that they look like hives. He spoke with the medical doctor about it and doctor said it was ok for me to get the 2nd dose of the vaccine. They think it was a delayed reaction. They have me monitored for 30 mins after the 2nd dose of the injection before I leave the site. I still have pain and red bumps so I went to see my primary doctor on 01/07/21. The doctor said that I have shingles. I told him that I never had shingles before and he said maybe the vaccine trigger it. He prescribed me some medications for the shingles. I don?t know if the vaccine trigger the shingles or just coincidence but I want to report this maybe someone might have the same experience. Thank you.
45 2021-01-07 pain in extremity sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old ... Read more
sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received first dose of bnt162b2 (BNT162B2 also reported as COVID-19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unspecified date at single dose, for Covid-19 immunisation. Medical history included rheumatoid arthritis and allergic reactions (unspecified). Concomitant medications were not reported. After receiving the first dose of the vaccination the patient experienced a sore arm on an unspecified date. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-01-07 tingling minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, th... Read more
minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, the roof of my mouth began to tingle and go numb as. NO difficulty swallowing or breathing, No changes in the vitals and I was given benedryl by mouth and observed for 30 minutes with no further issues and all symptoms resolved. My right arm was tingling and weak also but to date all symptoms has resolved.
45 2021-01-08 bell's palsy Bell's Palsy started 12/24 or 12/25/2020 Narrative: Currently being treated by her Primary Care Pro... Read more
Bell's Palsy started 12/24 or 12/25/2020 Narrative: Currently being treated by her Primary Care Provider with prednisone
45 2021-01-08 numbness, flushing I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot adm... Read more
I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot administration, felt itchy on limbs, then trunk and neck, then ears, eyes and into scalp. Symptoms progressed over the next 2 hours (flushed neck and then lips felt tingly and numb). At 7:30 my soft palate started to feel numb and I started to have some difficulty swallowing. Went to ER. Symptoms continued. After IV meds given swallowing difficulty continued to worsen so I was given a low dose shot of Epi. Swallowing improved (not to normal but not as severe) over the next hour but itchiness returned. It is now 8:00pm on 1/9/2021 and I continue to have itchiness, my tongue and soft palate are still numb but I am able to swallow fairly well and my entire face has decreased sensation to touch.
45 2021-01-08 night sweats Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hour... Read more
Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hours, pulse 100, night sweats, dizziness and slight headache after Tylenol
45 2021-01-08 pain in extremity Sore arm and low-grade headache for 3-4 days. Day 1, approx 4 hours after Pfizer dose 1, got headach... Read more
Sore arm and low-grade headache for 3-4 days. Day 1, approx 4 hours after Pfizer dose 1, got headache. Took Aleve, headache gone. Day 2 at 1am, woke up with pretty bad arm pain ("why does my arm hurt so bad? Have I lifted too much weight at the gym?") and headache Did nothing; went back to sleep. Day 3, took Aleve again in the evening; headache gone. Day 4, mild headache. Day 5 and on, feeling fine. On Jan 5, for 4 days straight, I fell asleep at 6 and 7 pm. Normally I go to bed at 9am ( I get up at 4am). Felt fine enough to work, just tired at night more than usual. My 2nd dose is scheduled Jan 15 at noon.
45 2021-01-09 pain in extremity slight headache fatigue sore arm
45 2021-01-10 weakness, discomfort, muscle spasms Chills with no fever; Cramping in legs; super tired with no energy; Body aches; tiredness/Feeling su... Read more
Chills with no fever; Cramping in legs; super tired with no energy; Body aches; tiredness/Feeling super tired with no energy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that the 45-year-old female patient who receive first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on Saturday (02Jan2021) at single dose (once by injection in the right arm) for covid-19 immunisation. Medical history included ongoing Hypothyroidism from 2008. Concomitant medications included levothyroxine at 75 ug ongoing from 2008 for Hypothyroidism. Medical Professional and told by her work that she could get it because contact with COVID patients. The consumer calls for information about if the side effects she is experiencing after the administration of the COVID-19 vaccine will last for more days. The consumer reported tiredness and other side effects to DSU. A Consumer calls for information about if it would be appropriate the second dose of the COVID-19 vaccine is not administered considering that she had adverse reactions. Consumer calls for information about if the second dose of the COVID-19 vaccine would cause her more side effects than the first one. Received the vaccine on Saturday, 02Jan2021. The day she got it she did not feel anything at all. She was completely fine. She did not even have pain at the injection site. The next day, on Sunday she started feeling super tired with no energy, had body aches, and cramping in legs from 03Jan2021. She has had these for the past 3 days now. She also had chills with no fever from 03Jan2021 to 05Jan2021. She took Tylenol for the first 2 days, but it did not help her at all. She is feeling a little better today, but not much. Her question is, how long will these side effects last? Tylenol: She says it did help a little bit. She think she would just sleep because she was uncomfortable. The Tylenol just did not make her symptoms go away completely. LOT/Batch: AA46487, EXP: Apr2022 UPC: The consumer says the number under the barcode is: 5187536. Feeling super tired and body aches: Has improved about 20%. She says these are all medically significant as she is not able to do what she was able to do before getting the vaccine. She is super tired with no energy and she is confined to her bed most of the time. The consumer confirms this is her first dose of the COVID Vaccine. She thinks she got the standard dose. Vaccine card does not have the expiration date or NDC written on it. Unknown causality. She said that she could be positive for COVID. She is unsure. The outcome of the event Chills with no fever was recovered. The outcome of the event Cramping in legs was not recovered. The outcome of the other events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-01-10 bell's palsy, slurring, facial paralysis Patient reports having Bell's Palsy with photographic evidence that was noticed approximately 11 hou... Read more
Patient reports having Bell's Palsy with photographic evidence that was noticed approximately 11 hours (at 7:00pm) after vaccine administration. Patient reports having slurred speech and facial drop. Took muscle relaxant (Robaxin) and prednisone (5 days). Bell's Palsy resolved by 01:00am.
45 2021-01-10 feeling hot Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improv... Read more
Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improving.
45 2021-01-10 flushing Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, di... Read more
Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, difficulty swallowing. Presented with elevated BP, pulse, normal O2. Symptoms came in waves with increasing frequency. Nausea also occurred as symptoms continued. Patient was monitored for ~15 minutes before Epi Pen (.03mg) was administered. Patient was transported to hospital by ambulance.
45 2021-01-10 hot flush Headache, Myalgia, Fever, Injection site pain, chills, hot flashes Narrative:
45 2021-01-10 numbness, bell's palsy, facial paralysis BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal ... Read more
BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal headache at night and took Tylenol 500 mg for headache relief. January 4, 2021- The slight numbness in tongue continued and my face started to feel a little different too. I had headaches on and off throughout the day and evening. January 5, 2021- Woke up to get ready for work and noticed that my right eyelid was a little swollen and the right side of my mouth looked different. I arrived at work and my right eye was not closing properly and I was having difficulty blinking. I left work an hour later and went to ER to seek treatment. I was prescribed Prednisone and Valacyclovir for a seven day course. The first time I had Bells Palsy was in 1997 when I was 22 years old.
45 2021-01-10 numbness Sunday 1/3/21- Numbness in tongue and pounding frontal headache at night. Took tylenol 500 mg. Monda... Read more
Sunday 1/3/21- Numbness in tongue and pounding frontal headache at night. Took tylenol 500 mg. Monday 1/4/21- Started feeling some slight numbness on right side of face and front of tongue, headaches continued on and off throughout the day. Tuesday 1/5/21- Woke up to get ready for work and I noticed my right eyelid was a little swollen and right side of my mouth was numb and smile was slightly crooked. Arrived at work and my right eye was not blinking properly. I went to ER room to seek treatment and was prescribed Prednisone and Valacyclovir. Wednesday 1/6/21- Started with right ear pain that radiated down to right side of neck. This is the second time I've had Bells Palsy. First time was in 1997 when I was age 22.
45 2021-01-10 muscle spasms, burning sensation Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms an... Read more
Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms and in her left knee/both of her thighs swollen, burning and itching on both knees; Hives on both arms and left knee; both of her thighs swollen, burning and itching on both knees; Burning and itching on both knees; neck feels like someone is sitting on the back of it/Left side neck pressure and throbbing; Left side neck pressure and throbbing; Lower back spasms; This is a spontaneous report received from a contactable consumer. A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine in Dec2020 (reported as "Thursday"). She began experiencing symptoms on Friday (as reported). Her left nostril stopped up and had sinus pressure in her head. On Saturday and Sunday (as reported), her left nostril was not stopped up but still had pressure in her head. On Monday (as reported), she began to feel burning sensation in both arms and in her left knee. When the patient was de-gowning PPE while at work, she found hives on both arms and left knee. She took BENADRYL and applied cold compress to site. Later Monday (as reported), she woke up to both of her thighs swollen, burning and itching on both knees. Her neck feels like someone is sitting on the back of it. She experienced left side neck pressure and throbbing and lower back spasms. The patient would like to know if these symptoms have been reported and what should she do. The outcome of the event "left nostril stopped up" was recovered on an unspecified date; "sinus pressure in head" and "pressure in head" was not recovered; and the outcome of the remaining events was unknown. Information on lot/batch number for the product has been requested.
45 2021-01-10 pain in extremity About 3 hours after vaccine severe arm pain in left arm which I expected was normal shortly after an... Read more
About 3 hours after vaccine severe arm pain in left arm which I expected was normal shortly after and still today intermittent vision(focus) issues and twitching of right eye with some slight right eye pain
45 2021-01-10 pain in extremity arm soreness and pain with movement, "super sleepy" " I could not speak tomy daughter" headache, t... Read more
arm soreness and pain with movement, "super sleepy" " I could not speak tomy daughter" headache, throbbing arm pain
45 2021-01-11 feeling cold, feeling hot Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afterno... Read more
Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afternoon around 4 or 5 got really hot and then in the evening around 9 got really cold and face started to itch. chin was bumpy and face was itching, eyes were still hurting with slight headache. I did have vivid dreams at night and slept not well. in the am my face was itchy red eyelids and under eye, patch like rash on face and itch . Ankles hurt to walk (joints hurt) and arm site was painful and hurt. was cold on and off during day and monday it was hard to wake up, v ery drosy and exhausted. Later that day the face cleared up and i could walk fine and headache was gone . I did feel a little cold monday night. Tuesday everything gone except a slight itch here and there on my face. I feel fine and arm pain is gone as well.
45 2021-01-11 feeling hot, cold sweat Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the ... Read more
Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; My whole body was as if I was sun burnt; My heart started to race; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2, (Pfizer COVID Vaccine, lot number: EK9231, expiry date: Apr2021) intramuscular on an unspecified date at single dose on right arm for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included nortriptyline for migraine, botulinum toxin type a (BOTOX) for migraine and birth control medication. The patient stated that, "I was wondering if this was a reaction to the vaccination I had today. So I ended up 3 hours after I received the vaccine, I got very hot and clammy but at the same time had the goosebumps and then my whole body was as if I was sun burnt and my heart started to race. And then my whole body was red as if I had a sunburn. Actually I went to the ER today and they just did lab work because of the way I was feeling. All they gave me in the emergency room is IV fluids." Therapeutic measures taken as a result of the events included IV fluids. The outcome of the events was unknown.
45 2021-01-11 flushing Dizzy; flushed after injection; This is a spontaneous report from a contactable Other HCP for hersel... Read more
Dizzy; flushed after injection; This is a spontaneous report from a contactable Other HCP for herself. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EK9231), via an unspecified route of administration in left arm on 03Jan2021 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse. Patient was allergic to some chilis and animals. There were no concomitant medications. The patient experienced dizzy, flushed after injection on 03Jan2021. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, the patient been not been tested for COVID-19. Outcome of events was recovered in Jan2021.
45 2021-01-11 hypersensitivity of all senses, tingling Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility ... Read more
Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility and soreness to the touch in the arm; Eyes were really heavy; Headache; Chills; Muscle pain; Injection pain; Injection site swelling; Injection site itchiness; Sensation on my face like when eating spicy food. It is a tingling sensation; Tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 (15:20) at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. On 31Dec2020, the patient had injection pain; injection site swelling; injection site itchiness; had sensation on the face like when eating spicy food further clarified as a tingling sensation; had tiredness. On 03Jan2021, the patient had chills and muscle pain. On 05Jan2021, the patient had headache, and eyes were really heavy. On an unspecified date, the patient had problems with arm mobility and soreness to the touch in the arm. The patient had received treatment for all the reported events. The outcome of the events was recovered on 31Dec2020 for 'injection pain', 'tiredness'; was recovered on an unspecified date for 'injection site swelling' and 'injection site itchiness', 'problems with arm mobility and soreness to the touch in the arm' and 'problems with arm mobility and soreness to the touch in the arm'; was recovered on 03Jan2021 for 'chills' and 'muscle pain'; was not recovered for 'headache'; and was unknown for 'sensation on the face like when eating spicy food further clarified as a tingling sensation'.
45 2021-01-11 pain in extremity, feeling hot A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was ... Read more
A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was sleeping I had very vivid dreams. I was cold all night. When I woke up my arm was sore to touch , to move and both ankles hurt to walk and I started itching on my face. Started Saturday in the evening( chin, nose) Eyelid and underneath was red and I also had a headache. I had blotches on my cheek. Next day I woke up and no change but I was extremely fatigued.. Monday 10am it started going away. By evening majority of pain was gone. About 98% recovered. I still have some itching and chills.
45 2021-01-11 pain in extremity, nerve pain Right arm soreness; kinda like nerve pain; can't lift my arm up or reach the back; This is a spontan... Read more
Right arm soreness; kinda like nerve pain; can't lift my arm up or reach the back; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek5730, expiry date: unknown), intramuscular on the right arm on 16Dec2020 11:00 to at a single dose for an COVID-19 immunization. Medical history included hypertension, obesity, lymphadenopathy, and migraines. Patient was not pregnant at the time of vaccination. Concomitant medication included losartan, clonazepam (KLONOPIN), duloxetine hydrochloride (CYMBALTA), gabapentin (NEURONTIN), ascorbic acid, thiamine hydrochloride (VITAMIN B AND C COMPLEX), and zinc. The patient experienced right arm soreness, kinda like nerve pain and can't lift her arm up or reach the back on 16Dec2020. Outcome of the events was not recovered. No treatment was received for the events. The patient underwent lab test which included COVID test (nasal swab) on 19Dec2020 and 26Dec2020: both negative. The reporter considered the events non-serious.
45 2021-01-12 weakness, feeling hot after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrin... Read more
after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrine injection and 911. patient waited around for about an hour after vaccination - patient BP went up, felt weak, signs of weakness, tongue big and throat closing - patient refused epinephrine again, called on call doctor who suggested Benadryl 25mg. Facility gave patient 25mg Benadryl IM. Patient to be monitored at facility
45 2021-01-12 discomfort, cold sweat pt reported feeling rapid heart rate and faint. Skin cool and clammy, pt assisted to lie down, HR 13... Read more
pt reported feeling rapid heart rate and faint. Skin cool and clammy, pt assisted to lie down, HR 130's, BP 134/78. c/o feeling pressure in throat. Rapid response called and patient assisted to stretcher and transported to ED.
45 2021-01-12 discomfort Swelling, redness, itching and burning radiating out from injection site starting two days after, in... Read more
Swelling, redness, itching and burning radiating out from injection site starting two days after, increasing in severity over time, got to the size of an orange, went to urgent care, treated with steroids and antihistamines. All localized, no other symptoms. Medication started 1/13/2021 but the initial antihistamine helped with discomfort.
45 2021-01-12 feeling cold Chills, joint pain, redness/swelling/itching at injection site
45 2021-01-12 feeling hot At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck.... Read more
At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck. The next day this continued with a fever of 99-100, malaise, and chest discomfort. At the 48th hour, today?s date, fever still present, body aches are improved, but my head feels hot and now with a stiff neck. I feel very tired and mental status seems ?foggy?
45 2021-01-12 feeling hot HOT, HARD RED AREA, BLISTERING, PAINFUL
45 2021-01-12 flushing, numbness Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ... Read more
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider made aware at 09:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 BP 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 09:56 BP 164/89, heart rate 72, oxygen saturation 100% on room air, temperature 97.7, vitals checked again at 10:00 BP 158/95, heart rate 75, oxygen saturation 100% on room air, and temp 97.7. Heart palpitations resolved. Provider prescribed Diphenhydramine 25mg x2capsules to be taken at home. Provider referred patient to urgent care and follow up with PCP.
45 2021-01-12 flushing Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:2... Read more
Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:28: Pt c/o dizzy & chest tightness, appeared pale, monitoring; 08:34: Pt c/o increased chest tightness 130, 144/81, 22, 100% monitoring 08:36: Epinephrine .3mg given IM to R thigh, pt. reported flushing, pounding heart, 911 called; 08:40: Pt flushed.
45 2021-01-12 numbness, flushing Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ... Read more
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider notified at9:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 bp 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 9:56am temp 97.7, BP 164/89, HR 72, oxygen sat 100% on room air. Vitals at 10:00am BP 158/95, HR 75, oxygen sat 100% on room air, temp 97.7. Provider prescribed Diphenhydramine 25mg x2 capsules to be taken at home, and referred patient to urgent care and follow up with primary care provider.
45 2021-01-12 pain in extremity The day after the second vaccine I had significant arm soreness and some fatigue and malaise. On Sat... Read more
The day after the second vaccine I had significant arm soreness and some fatigue and malaise. On Saturday two days after the second dose I had significant dizziness which might be considered vertigo. I am now six days past the second vaccine and continue to have dizziness.
45 2021-01-12 pain in extremity In the first 12 hours after the vaccine I developed left arm pain. Approximately 12 up to 36 hours a... Read more
In the first 12 hours after the vaccine I developed left arm pain. Approximately 12 up to 36 hours after the initial vaccine was given, I developed low-grade fevers. headaches, myalgia, chills, and severe fatigue. It?s now about 48 hours later and I still experience mild fevers occasionally.
45 2021-01-12 pain in extremity Fever 100.9 for 5 days. Muscle aches, chills, headache. Arm pain entire left arm.
45 2021-01-12 tingling 12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow a... Read more
12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow and shoulder intermittently 12/26/2021-vomiting and constant severe burning pain in left arm. Applied ice pack 12/27/2021-went to ER for the constant severe pain. Given prescriptions for prednisone 60mg orally x two days and norco. Later that night left arm between elbow and shoulder was bright red and hot to the touch. Took Benadryl liquid and the redness/heat went away in 4 hours. Shoulder, tricep, and bicep have continued to hurt with tingling in fingers. Have seen primary care physician at clinic and Dr. with another facility. Have orders for an MRI and follow up with the other facility
45 2021-01-13 facial paralysis, tingling Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red ra... Read more
Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red rash on bilateral forearms; Patient developed Bell's Palsy 2-3 days later; This is a spontaneous report from a contactable consumer. A 45-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 23Dec2020 at 14:30 at single dose in left arm for covid-19 immunization. Medical history included mitral valve prolapse from an unknown date, and allergies: Cephalosporins and nut (peanut derived). Concomitant medication included epinephrine (EPIPEN) 0.3MG/0.3ML, fluticasone propionate 50MCG/ACT nasal spray. On 23Dec2020 at 14:45, the patient experienced allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms. Reactions resolved with no treatment. The patient developed Bell's Palsy 2-3 days later in Dec2020. Currently being treated with high dose steroids and acyclovir. All events required emergency room visit and physician office visit. All events were reported as non-serious by reporter. The outcome of event Bell's Palsy was not resolved, outcome of other events was resolved on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination, and it was unknown if the patient has been tested for COVID-19 since the vaccination.
45 2021-01-13 feeling cold FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJEC... Read more
FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJECTION SITE, FEELING BAD.
45 2021-01-13 flushing Flushed; This is a spontaneous report from a contactable other healthcare professional (patient). A ... Read more
Flushed; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 20:00 at a single dose for COVID-19 immunization. Medical history included HTN and pericarditis. Concomitant medication included valsartan, spironolactone, amlodipine, desvenlafaxine succinate (PRISTIQ) and ascorbic acid (C 1000). The patient experienced flushed on 08Jan2021 at 19:00. No treatment was received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no known allergies. No allergies to medications, food, or other products. Outcome of the event was not recovered. Information about batch/lot number has been requested.
45 2021-01-13 night sweats Headache, dizziness, fatigue, and night sweats, and slight nausea. I took Aleve for the headache, it... Read more
Headache, dizziness, fatigue, and night sweats, and slight nausea. I took Aleve for the headache, it did help.
45 2021-01-13 pain in extremity, hot flush shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nau... Read more
shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling
45 2021-01-14 weakness Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fat... Read more
Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fatigue; weakness; feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:00 at single dose on arm left for covid-19 immunisation. Medical history reported as none. Pregnant at the time of vaccination: No. Unknown if COVID prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced Increase bowel movements, fever, body ache, injection site pain, intermittent moderate headache, extreme fatigue, mild weakness, feeling unwell, all reported from 01Jan2021 07:00 PM (pending clarification). Treatment received for all the events included OTC ibuprofen. Outcome of events was recovering. No COVID tested post vaccination. Information on the lot/batch number has been requested.
45 2021-01-14 feeling hot Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); Extrem... Read more
Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1686) via an unspecified route of administration on 06Jan2021 11:00 AM at a single dose in the left arm for Covid vaccine. Medical history included GERD. Concomitant medication included omeprazole (received within 2 weeks of vaccination). The patient had known allergies to erythromycin and hydrocodone bitartrate/paracetamol (VICODIN). The patient was not pregnant at the time of vaccination. She was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She did not receive other vaccines within four weeks prior to the COVID vaccine. On 06Jan2021 16:00 (04:00 PM), the patient experienced extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours), it started 5 hours after injection and lasted 48 hours. Treatment was not received for the events. The events were non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 since the vaccination (post vaccination). The outcome of the events was recovered on 08Jan2021 16:00.
45 2021-01-14 flushing Patient felt heart racing, shaky, and flushed a few minutes after COVID shot number 1. VS 186/98 H... Read more
Patient felt heart racing, shaky, and flushed a few minutes after COVID shot number 1. VS 186/98 HR 97 RR 16 Temp 36.5 No SOB or throat tightness. Patient sat for 15 minutes after vital signs. Given water. Felt much better. BP 145/94 HR 87 RR 14. No more shaking of hands. Discharged from clinic and recommend to report for next shot and let them know to monitor for 30 minutes.
45 2021-01-14 hot flush, pain in extremity wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feel... Read more
wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feels tight, almost like she is congested
45 2021-01-14 hot flush wheezing tight chest headache had to use a breathing treatment hot flush sensation
45 2021-01-14 hot flush Approximately a minute after receiving it I felt a wave of heat start at my feet and go to my head. ... Read more
Approximately a minute after receiving it I felt a wave of heat start at my feet and go to my head. I then felt my heart rate increase. I took my heart rate from my apple watch and it was 145. Spoke to the nurse on site and she took my BP which was 185/140 (I am normally 120/80). Within a few minutes the heart rate started to drop but I was taken to the ED to be monitored. remained slightly tachicardic, but it was much better and BP dropped but was still elevated upon release -
45 2021-01-14 hot flush Hot flush feeling felt like she was going to pass out started getting wizzy and raspy breathing hasn... Read more
Hot flush feeling felt like she was going to pass out started getting wizzy and raspy breathing hasn't been great
45 2021-01-14 numbness, tingling, sensory loss Numbness & tingling of left arm. Loss of sensation to arm and fingertips. Redness to left palm and f... Read more
Numbness & tingling of left arm. Loss of sensation to arm and fingertips. Redness to left palm and fingertips.
45 2021-01-14 numbness After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then... Read more
After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then she couldn't remember her name and date of birth for 5 minutes. She then felt her throat was swelling. 911 was called and paramedics checked her blood pressure and vitals were within range. She was monitored at the hospital and was doing fine.
45 2021-01-14 pain in extremity Severe pain in both arms few hrs after injection given in left arm. Now, right arm swollen compared ... Read more
Severe pain in both arms few hrs after injection given in left arm. Now, right arm swollen compared to left. Carpal tunnel pain at wrist. Worse at night and when holding arm in downward position. Have not had carpal tunnel before. No injury to arms. No recent trauma or heavy lifting
45 2021-01-14 pain in extremity Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with feve... Read more
Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with fever 101.0, body aches, dizziness, fatigue enlarged lymph node at left axilla, same side as shot, mild nausea, and a sore left arm. Felt sick for about 12 hours with these symptoms, fever resolved slowly with ibuprofen. Symptoms mostly resolved in 24 hours, except I still have an enlarged lymph node - left axilla with throbbing pain. No fever.
45 2021-01-14 tingling About 10 min after receiving vaccine, patient began to feel lightheaded and paresthesia to distal an... Read more
About 10 min after receiving vaccine, patient began to feel lightheaded and paresthesia to distal and upper arm. Vital signs within normal limits. Improved
45 2021-01-15 weakness On 1/11/2020 I got my second dose and the same night I started feeling sick it felt tired, I felt fe... Read more
On 1/11/2020 I got my second dose and the same night I started feeling sick it felt tired, I felt feverish but no fever, achy, headache, weak it felt like I had the flu it lasted 3 days. Telehealth appointment with my doctor 1/12/2020
45 2021-01-16 weakness, feeling cold, pain in extremity 2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head woul... Read more
2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head would explode- severe left eye pain like my eyeball was going to Pop out 4 hrs post shot- chills no fever temp 97.1 fatigue- took a nap. 12 hrs post shot - severe headache, moderate arm pain and mild swelling at site. SEVERE joint pained tiny joints in ties feet, finger, wrists, neck jaw. Knees were the worst. 16 hours later the joint pain is unbearable . Muscle aching and headache continues at the same time as joint pain. 24 hours post Injection. Chills,moderate painful stomach aching from the inside. Nausea. No vomiting, no energy. Could not work, had to leave. 29 hours post shot- now all symptoms at the same time chills, headache, severe joint pain, stomach pain, nausea, felt like I couldn?t drive home or walk to my car. Got home. Called dr. Went to bed. Slept 14 hours. 48 hours post shot- symptoms decreasing. Headache mild joint pain is the worst. Tired and very cold feeling 72 hours- feeling much better.
45 2021-01-16 muscle spasms Fever, muscle spasms to the point of difficulty walking, severe nausea
45 2021-01-17 night sweats 4am 1/16: fever, chills, headache, and myalgia. Allodynia of scalp trunk and thighs, Acetaminophen a... Read more
4am 1/16: fever, chills, headache, and myalgia. Allodynia of scalp trunk and thighs, Acetaminophen and Aspirin helped somewhat. 9pm severe fatigue, followed by worsened fever, worsened headache, throat tightness, nausea, myalgia, and waking hourly until 8am. Oral temp at 9am (1/17) was 100.6. Acetaminophen plus aspirin helped. 1/17 all day headache, malaise, poor appetite, and crying. 1/18 woke every 3rd hour to change clothes from night sweats. By 9 am had abdominal cramps, low grade headache, still malaise, and still low appetite. Still not recovered fully.
45 2021-01-17 tingling, numbness Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) af... Read more
Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) after injection and spreading to entire face. Symptoms resolved 4 hours later. Intermittent palpitations starting during this time which have not resolved to this day. Twelve hours (time 0330) after injection experienced common reported adverse effects (arthralgia, myalgia, headache, chills, severe neck pain, headache) in addition to unexpected supraclavicular lymph node swelling on injection side. Consistent fever of 102 degree fahrenheit starting 12 hours (time 0330) post injection and lasting for 20 hours, after which remained 99-100 for an additional 8 hours. Started to take Tylenol 15 hours after vaccine dose (0630). Also have continued to have dull headaches since vaccine dose.
45 2021-01-18 flushing Cough, tachycardia, flushing. Initially improved without treatment, took antihistamine at home, but... Read more
Cough, tachycardia, flushing. Initially improved without treatment, took antihistamine at home, but cough and a feeling of pressure in face worsened. Cough persisted and she was unable to sleep that night. Took Benadryl, Pepcid and pushed fluids. No further airway prolbems, but did not work the next day. Was back at work and back to normal on Jan 15.
45 2021-01-18 flushing Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels... Read more
Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels wierd." Feeling anxious. At 3:10pm, BP 165/74 HR=78 O2 sat=99%. At:3:30pm, BP=155/72. Symptoms improving. Patient released from clinic at 3:32pm.
45 2021-01-18 pain in extremity Night of 2nd dose had chills/body aches. Developed diarrhea next day. Arm became swollen and sore,... Read more
Night of 2nd dose had chills/body aches. Developed diarrhea next day. Arm became swollen and sore, red and itchy. Continued to get progressively more red, sore, itchy and swollen. On day 5 post vaccination, seeing by primary care doctor and diagnosed with cellulitis. Placed on antibiotics.
45 2021-01-18 pain in extremity Left arm was sore all day Sunday and Monday. Monday night I noticed a lump in my armpit. It is painf... Read more
Left arm was sore all day Sunday and Monday. Monday night I noticed a lump in my armpit. It is painful and still there.
45 2021-01-18 tingling tingling in arm, progressive tingling and paresthesia in back and legs
45 2021-01-18 tenderness on Jan 13, 2021 I developed a rash on my back. It was a little tender. Then on 1/14th I developed a... Read more
on Jan 13, 2021 I developed a rash on my back. It was a little tender. Then on 1/14th I developed a little more rash on my left side and under my left breast. The rash is painful. Diagnosed with Shingles!!
45 2021-01-19 weakness Hives around the waist, weakness/ tired at 0500 1/20
45 2021-01-19 weakness Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 11... Read more
Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 112, RR 28 ,Pox 100% RA (at 1700) Repeat vitals at 1710 BP 217/110, HR 103, RR 32, Pox 97% RA. Symptoms became progressively worse. She was given water. She reports she takes Metoprolol and Nefedipine ( last dose 1/20/21) and HCTZ (last dose 1/19/21. She also began to report feeling weakness as well. Due to persistent symptoms she was transported to the ER at 1715 via wheelchair.
45 2021-01-19 breast pain 1st dose - feverish, all over body ache, HA, run down/ tired/ fatigue. 2nd dose - body ache and HA (... Read more
1st dose - feverish, all over body ache, HA, run down/ tired/ fatigue. 2nd dose - body ache and HA (both not as severe as 1st dose), two days post injection = painful and swollen right axilla lymphadenopathy and right breast pain...used right deltoid for injection site. Also, noted fatigue and chills w/o known fever.
45 2021-01-19 burning sensation, tingling 1/15 starting with burning tingling hands that become itchy and tingling, burning, hives, and itchin... Read more
1/15 starting with burning tingling hands that become itchy and tingling, burning, hives, and itching all through body that comes and goes. Could this be delayed reaction to vaccine? highly concerned about getting 2nd vaccine.
45 2021-01-19 numbness, flushing Rash, dizziness, flushed face, numbness to left side. Occurred approximately 3-5 minutes after the ... Read more
Rash, dizziness, flushed face, numbness to left side. Occurred approximately 3-5 minutes after the dose. Symptoms completely resolved after diphenhydramine within 75 minutes. Patient signed out against medical advice.
45 2021-01-19 numbness, tingling, cold extremities pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue are... Read more
pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue area. C/o LA hand coldness.
45 2021-01-19 numbness, tingling 3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States sh... Read more
3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area. 3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.
45 2021-01-19 pain in extremity 12/29/20 , left arm soreness, sinus issue, throat issue, which by 12/30/20 sinus/chest congestion w... Read more
12/29/20 , left arm soreness, sinus issue, throat issue, which by 12/30/20 sinus/chest congestion with cough. HD tested for Covid 19 (negative on 1/1/21) Started aka seltzer cold and flu medicine, seen in respiratory clinic on 12/31 - started new meds codeine with guaifanesin cough syrup, Flovent inhaler, and Mucinex Max strength cold and flu. 1/8/21, felt more fatigued and cough felt more violent. Seen again in respiratory clinic 1/11/21 negative chest X-ray and Covid 19 test, continue same regimen - rest, OTC, inhalers. 1/20/21, first day of feeling overall improvement, still ongoing cough.
45 2021-01-19 seizure like phenomena, tremor, numbness, weakness Started with HA/fever/fatigue and body aches on date of vaccine on 1/5/21. Also had shakes,and had n... Read more
Started with HA/fever/fatigue and body aches on date of vaccine on 1/5/21. Also had shakes,and had numbness loss of feeling to leg leg. Was admitted to Hospital for 5days. Had intermittnet seizure type episodes. Has had labs and imaging tests that have been neg Under the care of the A Neuro Group. MRI scheduled for 1/20/21. As of 1/20/21 feeling better but still weak.
45 2021-01-19 sensory loss a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, thro... Read more
a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, throbbing headaches, difficulty operating a vehicle. The dizziness has now gotten bad enough that it is causing nausea.
45 2021-01-20 weakness High temperature starting at 3:00 am (101.84, 38.8 Celsius), severe headache, pain all over the bo... Read more
High temperature starting at 3:00 am (101.84, 38.8 Celsius), severe headache, pain all over the body and shortness of breath, as soon as I tried to drink water I threw up, extreme tiredness and weakness. Slept basically the whole Sunday (1/17). Around late afternoon it started getting better and I was able to eat some soup. But still tiredness and weakness and shortness of breath. I took Ibuprofen 600 3 times that day but it didn't help. On Monday 1/18 headache got better but still extreme shortness of breath and weakness and back pain. Today 1/21 I'm still having shortness of breath and back pain.
45 2021-01-20 burning sensation, pain in extremity Since the 1/14/2021 Pfizer COVID vaccine, I had L 2nd MTP and R 3rd MTP burning sensation on 1/15/20... Read more
Since the 1/14/2021 Pfizer COVID vaccine, I had L 2nd MTP and R 3rd MTP burning sensation on 1/15/2021 (like I had foot blister or stubbed a toe). Then, I had petechiae with discoloration on 1/16/2021 and 1/17/2021. With my preexisting Raynaud, I believe the COVID toes again (pictures attached) are a COVID vaccine immunogenic response rather than COVID infection itself given my serial negative COVID PCR, absence of other symptoms, and only home/work social bubbles for > 7 days. I have reported to Pfizer for vaccine adverse events.
45 2021-01-20 cold sweat, tingling approx 15 minutes after receiving the vaccine, client started c/o tingling in hands and arms bilater... Read more
approx 15 minutes after receiving the vaccine, client started c/o tingling in hands and arms bilaterally, as well as clammy hands and light headedness. She also said her eyes were foggy. Vital signs monitored and o2 given per mask. She c/o frontal area head pain, resolved after being on O2 for 5 minutes. 4:05pm says clamminess in hands and light headedness improved. She was release to drive home and told to report to ER if she has any more problems. client does report today of having daily headaches since she received her shot.
45 2021-01-20 numbness Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was cl... Read more
Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was closing. Was rushed to the hospital.
45 2021-01-20 numbness Pain and numbness on the left side of the body from head to toes, lump on L side of throat
45 2021-01-20 migraine Migraine with nausea and vomiting, extreme fatigue x 48hrs
45 2021-01-20 migraine Migraine, exhaustion x 48hrs, nausea
45 2021-01-20 pain in extremity Site soreness,body ache,headache,chilling12/28/21 Tylenol around-the-clock, ice for site soreness 1... Read more
Site soreness,body ache,headache,chilling12/28/21 Tylenol around-the-clock, ice for site soreness 12/30/20 vomitted
45 2021-01-20 tingling, numbness Numbness, tingling, itching of left arm, whereas vaccine was administered to the right arm
45 2021-01-20 tingling Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, di... Read more
Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, diarrhea, rash, sore throat, headache
45 2021-01-21 weakness, pain in extremity Arm sore, Tired, weak, fever 100.3
45 2021-01-21 feeling cold Injection site pain, muscle aches, chills
45 2021-01-21 migraine, pain in extremity 2 hours post vaccine I was at observation at the ER due to reaction I had with the 1st dose. By 11:3... Read more
2 hours post vaccine I was at observation at the ER due to reaction I had with the 1st dose. By 11:30AM I had a slight headache that progressed to a migraine, around 8PM I started feeling flu like symptoms and chills. At the ER my temp was 99.7F the symptoms lasted for 24 hours but the soreness of the arm that lasted around 2 days.
45 2021-01-21 muscle spasms Muscle cramps, fever, nausea, chills, headache , Pain in armpit Treated with Tylenol, ibuprofen ,... Read more
Muscle cramps, fever, nausea, chills, headache , Pain in armpit Treated with Tylenol, ibuprofen , and mucinex cold and flu
45 2021-01-21 night sweats Headache, muscle pain (extensive), joint pain (extensive), chills and then night sweats. Generalized... Read more
Headache, muscle pain (extensive), joint pain (extensive), chills and then night sweats. Generalized malaise
45 2021-01-21 pain in extremity Mild headache Woke up to really sore arm Chills Low grade fever of 100.5 F Had covid 3 months ago
45 2021-01-21 pain in extremity Fever , severe chills , body aches , abdominal pain , arm pain
45 2021-01-21 pain in extremity R arm pain, fatigue after 1st shot. After second shot sinus pressure, started 1 hr after shot. Foll... Read more
R arm pain, fatigue after 1st shot. After second shot sinus pressure, started 1 hr after shot. Following day, r arm sore, fatigue sinus pressure continued. After second day, no more fatigue, sinus pressure but developed vertigo with nausea, vomiting and diarrhea.
45 2021-01-21 tenderness Vaccine received around 8am, 1/18/21. Normal day, no events, developed a little soreness at injectio... Read more
Vaccine received around 8am, 1/18/21. Normal day, no events, developed a little soreness at injection site. Woke up around 1:30am on 1/19/21 and could not go back to sleep with overall malaise and pain in my right axilla (ipsilateral to vaccine); upon palpation of this area, I could feel enlarged lymph nodes, very sensitive to the touch (never had this from a vaccine, and I take usual flu shots and others occasionally recommended). Malaise slowly went away during the day, pain in right axilla persisted, although not as bothersome for about 2 days. On 1/19/21, I also had myalgia, which were still present on 1/20/19, but slowly subsided. Today 1/22 the enlarged right axillary adenopathy is still palpable, mild to no pain.. No additional symptoms.
45 2021-01-23 numbness Immediate funny taste in back of nose, back of throat. Tingly tongue. In about 15 minutes, cheeks nu... Read more
Immediate funny taste in back of nose, back of throat. Tingly tongue. In about 15 minutes, cheeks numb and swollen feeling.
45 2021-01-24 flushing HA/CP/Flushed/SOB/Dizziness after 20minutes-- > was taken to ER
45 2021-01-24 feeling of insects crawling on skin Nausea, "crawling skin", achy muscles/joints, only lasted until 1/24 at around 8:00pm.
45 2021-01-24 numbness, numbness She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had bod... Read more
She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had body aches. Swelling in arm pits. Tightness in right chest and back. She did a lot of driving and arm went numb, but gone now she is home. Swelling in arm still there.
45 2021-01-24 pain in extremity, tingling, weakness I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm,... Read more
I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm, the worse headache ever, feeling nauseous and my body was so sore. Throughout the day I felt weak, sleepy and got light headed and went to bed. I had no appetite but I was very thirsty. I didn?t eat Sunday. Today (Monday) I woke up with those same issues and more. I have a sore throat it feels tight, I?m dizzy and just feel sick all around and still have no appetite but I?m thirsty and my finger tingle.
45 2021-01-24 pain in extremity About 13 hours after the vaccine she began having body aches and chills, headache and arm pain, extr... Read more
About 13 hours after the vaccine she began having body aches and chills, headache and arm pain, extreme thirst, temperature of 100.1. The next morning she had a temperature of 101.2 with improvement of the chills but ongoing headache and body aches.
45 2021-01-24 pain in extremity Thursday 1st day sore arm, 3pm Friday; my arm hurt, I couldn't stay awake-exhausted, I slept 3 hours... Read more
Thursday 1st day sore arm, 3pm Friday; my arm hurt, I couldn't stay awake-exhausted, I slept 3 hours and woke with a fever 100.3 treated with Tylenol. Saturday, fever 100.0 most the day and was tired. Sunday felt better. Today better.
45 2021-01-24 pain in extremity Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she... Read more
Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she lost her voice and she had face and neck/throat swelling
45 2021-01-24 tingling, discomfort About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and m... Read more
About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and my face felt heavy. I looked myself in the mirror, my face, cheeks and neck became very red like beet red and warm to the touch. I returned to the vaccine site and they observed me but the symptoms worsened, my eyes started getting puffy/ my cheeks started getting purple instead of red, and they sent me to the ER. At the ER they continued to monitor me and gave me IV Benadryl and IV Pepcid and IV steroids and said I had a delayed case of hives. Once I had all the IV medication the swelling went down and the hives on my arms and my back went away, the redness in my face and neck stayed until next day and I noticed after taking a warm shower the next day the redness returned on other parts of my body. I took a Benadryl. About after 2 days it was all resolved.
45 2021-01-25 weakness, pain in extremity, feeling hot I felt mostly fine all day. A little tired and my arm was sore. About 4:45pm, I started sweating a... Read more
I felt mostly fine all day. A little tired and my arm was sore. About 4:45pm, I started sweating and getting really hot. I felt like I might need to use the restroom (soon) and I was at the grocery store. So, I immediately left. My house is 5-7 minutes from the store. During this time, I experienced terrible pains in my stomach and lower abdomen. I barely made it through my door and had to run to my bathroom. I experienced diarrhea like I?ve never experienced in my life. It was painful and explosive. This lasted about 30 minutes on and off. Mostly on. Once I cleaned myself up, I was very tired and weak. I felt nauseous this entire night but have not had any other episodes. I also have not invested anything except water since this happened.
45 2021-01-25 feeling cold Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out... Read more
Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out. Felt better minutes later. Reports rash to body 2 weeks after 1st injection.
45 2021-01-25 tremor, hot flush Rapid Response Team called to vaccination observation room. Arrived to find patient sitting in chair... Read more
Rapid Response Team called to vaccination observation room. Arrived to find patient sitting in chair, reports immediately after receiving vaccine feeling flushed and shaky, BP checked 172/95 MAP 115. Denies PMH of HTN, reports baseline BP 120s-130s/60s-70s. Denies CP/SOB or throat scratchy/swelling but does report jaw pain. Reports only allergy is to PCN, last meal was a protein shake ~1 hour prior. Symptoms did not resolve when placed in supine position, reported the feeling of ?flushed? worsening. Decision made to transfer patient to ED for further evaluation. ED work-up negative. Was observed for one additional hour in ED and discharged to home. No further symptoms documented in ED.
45 2021-01-26 weakness, migraine I'd heard about these side effects, was more than I expected, couldn't go to work that day since I w... Read more
I'd heard about these side effects, was more than I expected, couldn't go to work that day since I was in bed with side effects. Felt like more than any vaccine I'd received in my life, so decided to report just since this is a new vaccine. About 10 hours after vaccine, chills and fever started, fever up to 101, body weakness, lack of appetite, headache/migraine. Insomnia that night, up all night due to symptoms. . All symptoms except migraine resolved over the next 24 hours. Migraine continued so I took 50 mg imitrex x 3 over the course of the next 36 hours until that finally resolved . So all symptoms gone after around 2.5=3 days.
45 2021-01-26 weakness Fever ranging from 102-104, headache, fatigued, weak, body aches
45 2021-01-26 burning sensation, tenderness Injection was given firmly and arm bled. Arm was hurting immediately. Two days after injection, pain... Read more
Injection was given firmly and arm bled. Arm was hurting immediately. Two days after injection, pain at injection site was gone but left pectoral muscle and anterior left rotator cuff began to ache. Six days post injection pain intensified and burning sensation began in left pectoral muscle, left clavicle, and left anterior rotator cuff. Arm was placed in a sling to reduce movement and anti-inflammatory meds and Tylenol were taken for the pain. Twelve days post injection pain subsided and I was able to stop using sling and meds. Currently only tenderness remains with certain movements.
45 2021-01-26 burning sensation, tenderness Injection was given with some force, arm bleed at injection site, arm started hurting immediately an... Read more
Injection was given with some force, arm bleed at injection site, arm started hurting immediately and continued for 2 day. Two days after injection left pectoral muscle and left anterior rotator cuff became achy. Six days post injection moderate to severe pain with burning sensation occurred in left pectoral muscle, around left clavicle, and left anterior rotator cuff. Pain continued for 5 days. I placed arm in sling to reduce movement and took anti-inflammatory meds with Tylenol for the pain. 13 days post injection, pain subsided. I am currently able to move arm without pain, only tenderness around anterior rotator cuff remains. No accidents occurred.
45 2021-01-26 discomfort lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on ... Read more
lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on the injection side and it's painful; This is a spontaneous report from a contactable nurse and other hcp (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: EL1283, expiry date: unknown), via an unspecified route of administration on 11Jan2021 09:00 at single dose (left deltoid) for COVID-19 immunization. There were no medical history and concomitant medications. On 12Jan2021, patient had lymph node swelling on the same arm as the injection site. It got worse on the 13th. She described her experience as uncomfortable. She was asking how long it is expected to last. It was further reported that the patient received first Covid-19 vaccine on 11Jan2021 and is doing well, but had lymph node swelling in axillary area on the injection side and it's painful on 12Jan2021. She wanted to know how long it will be like that and if it doesn't go away when should she seek medical attention. Received the vaccine on the 11th and a couple days later had the lymph node swelling. She then clarified lymph node swelling started the 12th. Mentioned it got worse yesterday and it's staying about the same today with the swelling and is very uncomfortable (Jan2021) and is persisting. Causality not provided. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in the past. Vaccination Facility Type was Clinic. The outcome of the events was not recovered. Events reported as medically significant.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events swollen lymph nodes and lymph node pain. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-01-26 flushing Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of recei... Read more
Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of receiving vaccine. Transported to ER. Still has rash as of 1/27/2021 face, behind knees, and torso.
45 2021-01-26 hot flush intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; p... Read more
intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic. Medical history included mild asthma and known allergies to bee stings. There were no concomitant medications. Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-01-26 pain in extremity, numbness Severe anxiety ( Pt has never had anxiety before in her life), Pain in arm tremendous, numbness in a... Read more
Severe anxiety ( Pt has never had anxiety before in her life), Pain in arm tremendous, numbness in arm. Pt still having Anxiety.
45 2021-01-26 pain in extremity mild arm soreness that lasted a few days; headache; This is a spontaneous report from a contactable ... Read more
mild arm soreness that lasted a few days; headache; This is a spontaneous report from a contactable nurse (patient). This 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 22Dec2020 09:30 at single dose on the right arm for COVID-19 immunization. The patient's medical history included hypertension, anxiety, degenerative arthritis and allergies: sulfa. The patient's concomitant medications were none. No other vaccine received in four weeks. Facility type vaccine was workplace clinic. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. After first shot given at 09:30 by 12:00, patient had a headache and mild arm soreness that lasted a few days. No treatment received. Outcome of the events was recovered. Information on the lot/batch number has been requested.
45 2021-01-27 weakness, pain in extremity Body aches (muscles and joints); Body aches (muscles and joints); tiredness; weakness; left arm very... Read more
Body aches (muscles and joints); Body aches (muscles and joints); tiredness; weakness; left arm very sore; left earache; back and neck pain; back and neck pain; Fever 102; Chills; Body aches (muscles and joints); This is a spontaneous report from a contactable consumer (patient herself). This 45-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL33029), via an unknown route, on 16Jan2021 (at 09:45) at single dose administered on the left arm for COVID-19 immunisation, administered at hospital. Relevant medical history included high blood pressure, asthma and COVID-19 (prior to vaccination). The patient was receiving concomitant medications (unspecified). On 17Jan2021 (at 08:00 AM), the patient developed fever 102, chills, body aches (muscles and joints), tiredness, weakness, left arm very sore, left earache, back and neck pain. It was unknown if the patient received treatments for the events. The patient was recovering from the events.
45 2021-01-27 weakness Chills, body aches, weakness, fatigue
45 2021-01-27 feeling hot Felt suddenly hot, sweaty, dizzy. H20 given, resolved on own stayed 30 min
45 2021-01-27 feeling hot Patient with a PMH significant for allergic rhinitis and cyclic neutropenia, as well a pre-syncope w... Read more
Patient with a PMH significant for allergic rhinitis and cyclic neutropenia, as well a pre-syncope with previous blood donations received COVID-19 vaccine at 0645 and approximately 1 hour later developed a generalized feeling of warmth, followed by lightheadedness/dizziness. She denies frank LOC. She also reports palpitations and a rapid heart rate. She denied any rash, pruritis, dyspnea or chest pain, or N/V/D. Patient works in hospital and was transported to ED and upon arrival vitals were stable with HR of 79, BP 151/84, SaO2 of 100% on RA. Additional information for Item 18: Patient treated with IVF and released. Patient discharged to home and by 1:00pm that day was no longer symptomatic. She does endorse pre-syncope with previous blood draws.
45 2021-01-27 feeling of body temperature change, night sweats Fatigue, Hot and cold body temperature, chills, dizziness, flighty-light headed, night sweats, stoma... Read more
Fatigue, Hot and cold body temperature, chills, dizziness, flighty-light headed, night sweats, stomach and back pain
45 2021-01-27 flushing Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contacta... Read more
Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El01Y0, expiration date not reported), intramuscular on the left arm, on 08Jan2021 at 10:30, single dose for Covid-19 immunization. The patient has no medical history and no concomitant medications. The patient previously took the first dose of bnt162b2 (Lot number: EJ1685), intramuscular on the right arm, on 18Dec2020 at 10:00 AM for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Jan2021, at 10:35, the patient experienced flushing feeling with tachycardia 5 minutes post vaccine. On 15Jan2021, she is day 7 post vaccine and experiencing panic/anxiety, tachycardia, and vertigo type feelings. Since the vaccination, the patient has not been tested for COVID-19. The patient received treatment (prescription/monitoring) for the events. The outcome of the events was not recovered. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
45 2021-01-27 flushing Rosacea, flushing
45 2021-01-27 numbness, feeling hot 1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 ... Read more
1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 Went to urgent care for mild swelling and numbness on left side of face, scalp, ear. Also very dry flaky skin. Given desnoide cream, and instructed to take Claritin 1/13/21-1/15/21 Took Claritin, and all symptoms resolved except for dry skin 1/16/21-1/17/21 Did NOT take Claritin 1/18/21 Mild facial numbness, on left. Took Zyrtec-D, symptoms improved 1/19/21 No apparent numbness. Took Claritin 1/20/21 Possibly hint of numbness. Extremely dry skin and scalp. Took Claritin. Used desonide. Only skin around eyes slightly swollen. 1/21/21 Mild-mod numbness on left side of face. Extremely dry skin and scalp. Face feels warm. Took Claritin
45 2021-01-27 pain in extremity moderate headache; body ache; tender arm; diarrhea; chills; nausea; vomiting; This is a spontaneous ... Read more
moderate headache; body ache; tender arm; diarrhea; chills; nausea; vomiting; This is a spontaneous report from a contactable Other Health Professional reporting for herself. A 45-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142), via an unspecified route of administration on 15Jan2021 09:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 45 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. She received unspecified concomitant medications. On 16Jan2021 at 23:45 the patient experienced moderate headache, body ache, and tender arm and 40 hours after the dose, she developed diarrhea, chills, nausea & vomiting lasting 4 hours. All the events were considered non serious. No treatment was received for the events. The events had resolved on an unspecified date in Jan2021. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
45 2021-01-27 pain in extremity Sore L arm; body aches; chills; diarrhea; headache; This is a spontaneous report from a contactable ... Read more
Sore L arm; body aches; chills; diarrhea; headache; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982, expiration date unspecified), intramuscular on 14Jan2021 15:30 at single dose (left arm) for Covid-19 immunization. Medical history included vitamin d deficiency (def), Beta Thalassemia, some shellfish allergy, Sulfa allergy and COVID-19, which was prior to vaccination. Concomitant medication included vitamin D3. The patient received vitamin D3 within 2 weeks of vaccination. On 15Jan2021 at 06:45, the patient experienced sore left (L) arm, body aches, chills, diarrhea, and headache. The patient did not received treatment for the events. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had not been tested for Covid-19 since the vaccination. Outcome of events was recovering.
45 2021-01-28 weakness Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spike... Read more
Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spiked, severe headache, severe abd pain, seen at Urgent Care and sent to ER. Given meds and sent home. Next day seem at clinic and again sent to ER. . Given IV fluids, IV meds and after four hrs sent home. Experienced extreme weakness. Could barely get out of chair or walk. ED visit 1/15/2021 for acute nonintractable headache, epigastric pain, adverse effect of vaccine. Presents to the ER with epigastric abdominal pain, nausea, and headache after receiving second dose of Pfizer COVID-19 vaccination yesterday at 6 AM. Patient states symptoms started last night. Treated with IV fluids, Reglan, Benadryl, Toradol, and Floricet. Abdominal pain totally resolved and headache pain improved. Discharged to home with prescription for Reglan 10mg PRN. She does have a history of chronic migraines and already has Maxalt at home and was given a prescription for Floricet today which she is already filled.
45 2021-01-28 burning sensation petechiae with discoloration; petechiae with discoloration; L 2nd MTP and R 3rd MTP burning sensatio... Read more
petechiae with discoloration; petechiae with discoloration; L 2nd MTP and R 3rd MTP burning sensation; foot blister; stubbed a toe; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284) at Left arm, intramuscular on 14Jan2021 16:45 at single dose for covid-19 immunisation. Medical history included Sjogren's, Raynaud, s/p Total abdominal hysterectomy (TAH)/Bilateral salpingo-oophorectomy (BSO) sex cord sclerosing stromal tumor, and known allergies: Sulfa. Patient did not have Covid prior vaccination. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), leflunomide, ciclosporin (RESTASIS), pilocarpine, colecalciferol (VITAMIN D), fish oil (OMEGA 3). Since the 14Jan2021 Pfizer COVID vaccine, the patient had left (L) 2nd Metatarsophalangeal (MTP) and right (R) 3rd MTP burning sensation on 15Jan2021 10:00 (like she had foot blister or stubbed a toe). Then, she had petechiae with discoloration on 16Jan2021 and 17Jan2021. No treatment was received for the events. The patient lab data included Covid PCR Test (Nasal Swab): negative on 15Jan2021. The outcome of events was recovering.
45 2021-01-28 hypersensitivity of all senses Fever (as high as 103.1 after Motrin); Headache; Chills; Joint pain; Inj site pain; Skin sentivity; ... Read more
Fever (as high as 103.1 after Motrin); Headache; Chills; Joint pain; Inj site pain; Skin sentivity; General feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249) via an unspecified route of administration in right arm on 15Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included hypertension, vertigo. The patient's concomitant medications were not reported. The patient was allergic to PCN, Sulfa, Keflex, Solodyn (Tetracycline). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 04:30 AM, the patient experienced fever (as high as 103.1 after Motrin), headache, chills, joint pain, injection site pain, skin sensitivity, general feeling unwell. No treatment was received for other adverse events. The patient did not pregnant at the time of vaccination. Events outcome was recovered.
45 2021-01-28 tingling, tremor, numbness Pt waited her 15 minute waiting period without issue. Pt then left the clinic & reports that she did... Read more
Pt waited her 15 minute waiting period without issue. Pt then left the clinic & reports that she did not feel right so she came back to the clinic. Pt reported some numbness & tingling in her arms & hands, nausea, increased anxiety, & shaking. 1mL dexamethasone 4mg/mL given IM to right buttock. Pt placed on 2LPM 02 via NC for comfort. Pt tolerated well.
45 2021-01-28 tremor severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report f... Read more
severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself. A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-01-29 feeling hot, flushing About 5-10minutes after vaccine I felt flushed/warm. Reported to nurse who took my vitals. Elevated... Read more
About 5-10minutes after vaccine I felt flushed/warm. Reported to nurse who took my vitals. Elevated blood pressure and heart rate. Also felt slightly dizzy. Symptoms lasted about 45 minutes. At no time did I experience itching/swelling or rash. Also did not experience wheezing or difficulty breathing. Only treatment needed was vital sign monitoring. Vitals improved and no intervention was needed. I have had no further complications.
45 2021-01-29 flushing 15 minutes after receiving shot, I started feeling itchy in many places. My face flushed red and my ... Read more
15 minutes after receiving shot, I started feeling itchy in many places. My face flushed red and my skin has red splotches on my upper chest. I had just been released from the vaccination observation area, and I returned for additional guidance. They told me since I drove out of observation, they could not do anything and I had to go to an urgent care center. I phoned my regular doctor and the triage nurse in the office instructed me to take 2 Benadryl immediately. I drive to a pharmacy and took the Benadryl. The Benadryl relieved the symptoms for about 2.5 hours and then they returned. I took 2 Benadryl every 4 hours until the itchiness stopped approximately 12 hours after receiving the shot.
45 2021-01-29 flushing Tachycardia, high blood pressure, flushing Given Benadryl and observed in the ER
45 2021-01-29 cold extremities, feeling hot Pretreatment with prednisone 50 mg q6 x 3 doses starting 13 hours prior plus Benadryl 50mg po 1 hour... Read more
Pretreatment with prednisone 50 mg q6 x 3 doses starting 13 hours prior plus Benadryl 50mg po 1 hour prior. 20-25 minutes after injection began itching, rash on upper body, redness to body, lightheaded when stood up. Sought treatment from nurse & paramedic on site. Vital signs about 30 minutes after injection 187/107, hr 135, sats 98%. Given Benadryl 25 mg IM . Over next 30 minutes symptoms improved & bp came down to 145/80 and hr around 100. That evening whole body was red & rash on upper body- took Benadryl 50 mg. A week out remain with mild rash on chest, arms, neck & itching that comes & goes. Have been treating with Claritin during the day & Benadryl at night for 6 nights. Days 2& 3 after injection feet felt very cold, but face felt very hot when wearing a mask.
45 2021-01-30 feeling cold, numbness After 2nd shot within an hour I started to feel a cold sensation flow through my body and my right a... Read more
After 2nd shot within an hour I started to feel a cold sensation flow through my body and my right arm and hand felt numb.
45 2021-01-31 discomfort, feeling hot, numbness, tingling, tremor 1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt h... Read more
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 200/110, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to 160/92 within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 and blood pressure was elevated for 12 hours before returning to my usual results.
45 2021-01-31 facial paralysis Patient started she had numbness to tongue area and HA to frontal lobe. Taste to food was different ... Read more
Patient started she had numbness to tongue area and HA to frontal lobe. Taste to food was different and the continues of HA and numbness sensation during the day/ evening. She was unable to close her R eyelid and R side drooping. The HA increased with time after two weeks the R side of the face different mouth and R side was swollen. She then seek medical treatment at the ER where she received prednisone and valacyclovir for one week treatment.
45 2021-01-31 feeling hot, tingling, discomfort Got vaccine at 930am. Woke up morning after the vaccine about 930am with tingling/severe pain should... Read more
Got vaccine at 930am. Woke up morning after the vaccine about 930am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then tylenol mid day. That evening had fatigue and pain all over, slight head ache, chills and then turned to temp 99.9, very warm/uncomfortable. Tylenol again. Woke on Sunday better just fatigue and achy.
45 2021-01-31 feeling hot, tremor, tingling, numbness, discomfort 1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt h... Read more
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 190/100, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to normal level within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 for 12 hours before returning to my normal rate of 60.
45 2021-01-31 feeling of body temperature change, migraine Later that night she felt like she had the flu, nausea, vomiting, later that day diarrhea, and a mig... Read more
Later that night she felt like she had the flu, nausea, vomiting, later that day diarrhea, and a migraine at Left temple area, sweating, hot and cold chills, after she was able to eat she felt better
45 2021-01-31 flushing DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT... Read more
DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT: acute tingling around mouth and tongue; BP spiked and face became very flushed. Waited with nurse until 1 hour post shot. BP stayed above normal all day, as did fatigue. 12 HOURS POST SHOT: sever headaches warranting migraine medicine but I only took Tylenol and Ibuprofen since Maxalt (10 mg) can raise BP. Alternated Tylenol and Ibuprofen every 3 hours but would only get about 2 hours of relief each time. This continued through the night. DAY 2 (Fri. 1/15/21): 23 HOURS POST SHOT: Headache remained. but was lessened after taking Mucinex D. Extremely fatigued, which remained throughout the day. 24 HOURS POST SHOT (9:00 am): Saw NP at clinic, BP was normal. Was prescribed Fioricet, ESGIC 50-325-40 and advised to take it if headache returned. If ineffective after 2 hours, advised to take Maxalt 10 mg. 10:10 am: took Fioricet with no impact to headache, took Maxalt at 12:10. 28 HOURS POST SHOT: Severe, painful heartburn in my chest and upper back - Mylanta provided no relief. Headache returned and started having severe abdominal pain and shortness of breath. 29 HOURS POST SHOT (~2PM) Went to urgent care; vitals were all normal. Received fluids and "GI cocktail" containing lidocaine. Heartburn pain subsided but headaches and abdominal pain. Was advised to go to Emergency Department and did. ED ran multiple labs and ECG to rule out gallbladder, pancreas, etc. Headaches and abdominal pain at this point were excruciating and debilitating. Shortness of breath was significant. ED staff said they have seen the different reactions I was having to the vaccine, just not all together in one patient at the same time. Pain subsided after fluids with Benadryl, Toradol and Reglan. Was discharged approximately 4 hours after arrival. MD prescribed Reglan for continued headaches through the weekend. DAY 3 (Sat. 1/16/21): 48 HOURS POST SHOT: Severe headache when I awoke. Reglan did not provide relief. After two hours, took Maxalt 10 mg . Headaches and significant fatigue continued with such severity I took Maxalt as frequently as allowed per dosing instructions. I stayed in a dark room until Monday (1/18/21, Day 5), ensuring I was staying well hydrated and nourished. The fatigue was so significant that movement was very labored. It should be noted that I am a very active person and I had zero energy and missed two days of work (Fri and Mon). DAY 4: headaches were less frequent DAY5 (Mon. 1/18/21): At 3:30 PM (~126 hours post shot) - it was like someone flipped a light switch and the fatigue and headaches were gone and I felt like I was back to normal. DAYS 6-7, (Tues. and Wed 1/19-20/21) - worked a normal day at work. DAY 8 (Thu. 1/21/21): extremely fatigued again, like over the weekend, but it only lasted today. Of note, the lips and tongue tingling would come and go following the initial weekend of severe reactions. While noticeable, it was not as significant as within the first 15 mins of receiving the dose. On Monday 1/25/21 at approximately 3:00 PM, the tingling was very noticeable and my BP spiked again. Since that time until now, I have had no reactions.
45 2021-01-31 hot flush Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swol... Read more
Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swollen lymph under jaw on neck.
45 2021-01-31 numbness Left hand numbness
45 2021-01-31 pain in extremity, breast pain nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling an... Read more
nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; headache; body aches at the slightest touch; fever; loss of appetite lasting 4 days; left upper arm/underarm/breast swelling and pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiration date not provided), intramuscular in the left arm on 14Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and hypothyroidism. The patient is not pregnant. The patient has no know allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 02:45, the patient experienced nausea, left upper arm/underarm/breast swelling and pain, headache nothing would take away, body aches at the slightest touch, fever, loss of appetite lasting 4 days and still with nausea, loss of appetite and headache. Treatment was not provided in response to the events. The outcome of the events was recovered with sequelae on an unspecified date in Jan2021. The patient has not been tested for COVID post vaccination.
45 2021-01-31 pain in extremity Patient developed fever of 103 and body aches the evening of her vaccination, and continued with fev... Read more
Patient developed fever of 103 and body aches the evening of her vaccination, and continued with fever of 101-103 for the next two days. She experienced headache and nausea for the next week. On 1/22/21 she developed pain and swelling in the right middle finger at the MCP and PIP joints, and then on 1/24/21 developed pain and swelling in the L fourth finger MCP and PIP joints. She also started her period after the vaccine was given and has continued to have daily vaginal bleeding since. Her hand pain is improved slightly as of today.
45 2021-01-31 tingling stiffness in lower back; warm tingling, sensation down her leg on the left side down toward her foot... Read more
stiffness in lower back; warm tingling, sensation down her leg on the left side down toward her foot area; left side of her body was completely sore; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 13Jan2021 12:27 at single dose on the left upper arm for COVID-19 immunization. Medical history included ongoing asthma and ongoing sinus issues. The patient's concomitant medications were not reported. The patient had no history of all previous immunization and no additional vaccines administered on same date of the Pfizer suspect. The caller reported that she took the Pfizer COVID vaccine and had some things going on afterward but she wasn't sure if the symptoms were side effects. She works in a doctor's office, this is how she was able to get the shot. The caller explained she stayed for the 15 minutes and immediately she started feeling stiffness in lower back on 13Jan2021. A couple days later (in Jan2021) she started having a tingling, warm tingling, sensation down her leg on the left side down toward her foot area. She got the shot on the left upper arm and so everything happening was on her left side. Her left side of her body was completely sore. She reported stiffness in the buttocks area, everything was sore on the left side. She had been using a heating pad on lower back and hip area and things are getting better. The tingling was still there but gotten better. The events did not require a visit to emergency room or physician office. No relevant tests were done. The outcome of the events was recovering.
45 2021-02-01 burning sensation, discomfort Following dose #2, had body aches and fever on day two (T 102.7) and felt better next day. Per fami... Read more
Following dose #2, had body aches and fever on day two (T 102.7) and felt better next day. Per family report starting complaining about L ear pain on Friday 1/29, On Sunday 1/31, started to experience dizziness and some L ear discomfort, Had cellulitis last summer after "new earrings" in left ear and assumed this might have been it, had NP check ear on Monday at work, some fluid on R ear. Monday evening pain increased, heaviness and muffled sound increased, pain increased, started to "burn" and "itch". Tuesday AM contacted three MDs, concerns of shingles. Diagnosis later that day, vesicles in L outer ear, started on antiviral and antibiotics. Pain and dizziness at work Tuesday morning however its only Tuesday night. Pain/burning still very intense.
45 2021-02-01 facial pain over left cheek bone feel sore, left side of neck sore as well; massaging to see if it goes away; no... Read more
over left cheek bone feel sore, left side of neck sore as well; massaging to see if it goes away; no dizziness, no vision changes, no HA, no change in speech
45 2021-02-01 feeling hot, tingling Patient received COVID vaccine Pfizer first dose in vaccine clinic. Her symptoms started 5 min afte... Read more
Patient received COVID vaccine Pfizer first dose in vaccine clinic. Her symptoms started 5 min after injection, lasted 10-15 min and resolved. She started feeling tingly in her arms, then noticed a red, raised, blotchy rash on her arms. She felt hot and a little weak in the legs. No oral swelling, throat tightening, shortness of breath, nausea, vomiting, diarrhea. Symptoms onset 5 min after vaccine, symptoms resolved spontaneously within 15 min. Patient transferred to ED. No symptoms in ED. Patient given Benadryl in ED. Observed, no further symptoms. Dc home with Epi pen
45 2021-02-01 numbness, tingling 1ST INJECTION WAS 1/28/21 THE EVENING AFTER 1ST INJECTION (1/29/21).. FEVER 102 MUSCLE AND JOINT ACH... Read more
1ST INJECTION WAS 1/28/21 THE EVENING AFTER 1ST INJECTION (1/29/21).. FEVER 102 MUSCLE AND JOINT ACHES, HEADACHE AND SWOLLEN AXILLARY NODES IN LEFT ARM LASTING ABOUT 24-36 HOURS. 4 200ML ADVIL TAKEN SWOLLEN NODES REMAINED SUNDAY MORNING AND I WOKE WITH LEFT SIDE OF MY FACE NUMB BUT FUNCTIONING WHICH CONTINUED FOR ABOUT 48 HOURS. TODAY (2/2/21) IS DAY 5 POST INJECTION, SWOLLEN NODES REMAIN AND PINS AND NEEDLES FEELING ON LEFT SIDE OF FACE
45 2021-02-01 migraine Headache, unspecified after vaccination, migraneous.
45 2021-02-02 weakness, tingling Since the vaccine I have experienced tingling of lips and face. The past few days I have started exp... Read more
Since the vaccine I have experienced tingling of lips and face. The past few days I have started experiencing more tingling/twisting sensations on left side of body and some weakness of left side of body as well as twitching of left eye.
45 2021-02-02 weakness Flu like symptoms: started getting week and tired. Went to bed about 11pm and could barely get up in... Read more
Flu like symptoms: started getting week and tired. Went to bed about 11pm and could barely get up in the morning at 4:30 am. Headache, low grade fever of 99.7, achy all over, a bit of nausea.
45 2021-02-02 involuntary muscle movements Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minute... Read more
Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minutes after receiving the vaccine; itchy eyes and puffiness in face on and off from time of vaccine to present (7 days later); vaccine and/or subsequent mild allergic reaction triggered Functional Neurological Disorder symptoms (involuntary muscle activations in legs, face and neck, dystonic posturing of feet)
45 2021-02-02 pain in extremity Chills, body aches, painful/heavy arm, and worst headache. Took tylenol and ibuprofen with no relief... Read more
Chills, body aches, painful/heavy arm, and worst headache. Took tylenol and ibuprofen with no relief.
45 2021-02-02 pain in extremity Extreme swelling, redness, and soreness in left arm, can barely lift.
45 2021-02-02 tingling, electric shock sensation, weakness Severe muscle pain to the point of tears for about 8-10 hours even after extra strength tylenol. Te... Read more
Severe muscle pain to the point of tears for about 8-10 hours even after extra strength tylenol. Temp 101.6 after extra strength tylenol. Severe fatigue, muscle weakness-could not get out of the bed or even sit upright in the bed for nearly 72 hours. Once the pain subsided, body aches, weakness and tingling began, mostly located in lower extremities and gluteal muscles. Yesterday, day, 4, weakness/tingling/feeling of electrical impulses throughout lower extremities which was intermittent. I am currently on day 5 now and still experiencing fatigue, aches/feeling of impulses throughout lower extremities intermittently. I have a Dr. appointment scheduled for tomorrow 2/4/2021
45 2021-02-02 tingling, numbness Extreme numbness and tingling in left hand, beginning 15 minutes after vaccination. Numbness was sev... Read more
Extreme numbness and tingling in left hand, beginning 15 minutes after vaccination. Numbness was severe enough to interfere with normal activities such as typing, texting, dialing phone. Patient became nauseated and very dizzy (unable to walk unaided) within 1 hour of vaccination. Numbness improved after 24 hours, and was back to normal after 72 hours. Nausea and dizziness lasted for 24 hours. No previous reactions to vaccines of any kind.
45 2021-02-03 burning sensation Skin redness/hands were red/red patches; hands were red and itchy; hands were red and itchy, burning... Read more
Skin redness/hands were red/red patches; hands were red and itchy; hands were red and itchy, burning.; extensive hives starting over dorsal hand surface, then wrists,eventually covering entire arms and patches over knees and lower legs; This is a spontaneous report from a contactable nurse (patient). This 45-year-old female patient received the fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date unknown), via an unspecified route of administration on 19Jan2021 09:15 at a single dose on the left arm for COVID-19 immunization. Medical history included COVID-19 and allergies: PCN. Concomitant medication included colecalciferol (VITAMIN D). The patient received no other vaccine in four weeks. Patient is not pregnant. On 20Jan2021 08:30, the patient developed skin redness, her hands were red, itchy, and burning. This was followed by extensive hives starting over dorsal hand surface, then wrists, and eventually covering entire arms. The patient also had patches over knees and lower legs. The events resolved with 20 mg prednisone and Allegra after a couple hours, except for the flat red patches which remained over the knees and surrounding skin. The patient has not been tested for COVID-19 post-vaccination. Outcome of the event "skin redness/hands were red/red patches" was not recovered and of the other events was recovered on an unspecified date.
45 2021-02-03 feeling cold Fever chills body aches and headache started about 7 hours after shot. Symptoms continued throughout... Read more
Fever chills body aches and headache started about 7 hours after shot. Symptoms continued throughout night. Fever resolved next day. Fatigue and brain fog all day until 7 pm when symptoms resolved very quickly. Tylenol and one dose of advil
45 2021-02-03 migraine I started to have aches, joint pain and a migraine with slight nausea on 2/1/21 @ 1700 after having ... Read more
I started to have aches, joint pain and a migraine with slight nausea on 2/1/21 @ 1700 after having the 2nd vaccine earlier that morning. The migraine persisted till 2/3/2021 at 0930. I called employee heath and was suggested to take some Tylenol and coffee. I continue to have mild joint pain, a mild headache, and no nausea.
45 2021-02-03 pain in extremity Left arm remained sore and warm to touch for several days. On 1/31/21 started having extreme pain wi... Read more
Left arm remained sore and warm to touch for several days. On 1/31/21 started having extreme pain with ROM of left should. Went for evaluation on 2/1/21, was diagnosed with left shoulder deltoid myositis after injection.
45 2021-02-03 pain in extremity sore arm, fatigue, body aches Narrative:
45 2021-02-03 tingling, discomfort Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. ... Read more
Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. I began to feel lightheaded and hot in chest. Vitals were take , BP was very high and HR was very high. My checks got tingly as well. I began to get the chills. This lasted approximately 2 hours.
45 2021-02-04 feeling hot Chills; It's kind of warm; I am really tired; This is a spontaneous report from a contactable consum... Read more
Chills; It's kind of warm; I am really tired; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization , paracetamol (TYLENOL) , via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history included diabetes. The patient's concomitant medications were not reported. The patient experienced chills, it's kind of warm and she was really tired. It was reported that the patient had side effects that wasn't bad, she took some paracetamol and today she noticed she need to take a few more. Consumer stated that she was just curious to know, how long can side effects last. She was not in any pain or anything but the chills and it's kind of warm. And she was just wondering how long was that supposed to last. The patient was really tired. The start date of events was reported on 21Jan2021. Paracetamol was reported as co-suspect. The action taken in response to the event for paracetamol was unknown. The outcome of the events was unknown. Information about lot/batch number has been requested.
45 2021-02-04 numbness, tingling Left-arm numbness, tingling, itching (vaccine administered on right-arm).; Left-arm numbness, tingli... Read more
Left-arm numbness, tingling, itching (vaccine administered on right-arm).; Left-arm numbness, tingling, itching (vaccine administered on right-arm).; Left-arm numbness, tingling, itching (vaccine administered on right-arm).; This is a spontaneous report from a contactable Pharmacist. A 45-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), intramuscular on 17Jan2021 at single dose for covid-19 immunisation . Medical history reported as none. The patient's concomitant medications were not reported. The patient experienced left-arm numbness, tingling, itching on 17Jan2021. vaccine administered on right-arm. The outcome of events was recovering.
45 2021-02-04 seizure like phenomena In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicate... Read more
In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicated so was not going through any withdrawal. She was getting vitals and CIW checked regularly. First dose of chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9. She had repeat vitals at 5:50pm, CIWA 1, vitals: P 67, 118/79, 94% on RA, T 98.3. she had complained of some "pressure in her head" and feeling anxious, but otherwise denied other complaints. she was talking with others in the group, then other patients report she suddenly started having seizure like activity around 6:45pm, med techs came to help and found her stiff, gurgling. they tried to get vitals on her, called 911, noticed that at 6:54pm she had lost a pulse and they started CPR. paramedics arrived at 7:08pm and she was brought to ED. Pt BIBA in cardiac arrest. Pt was at Detox Center when she was reported to have seizure-like activity followed by collapse. She was found to be pulseless and CPR initiated by staff members. EMS arrived and performed approx 15 min of CPR and gave pt epi x 3 and bicarb. No shocks administered but they did not report a rhythm. In the emergency room the patient arrived and was found to be pulseless with PEA arrest, CPR was initiated, patient was intubated. ROSC ultimately achieved, patient remained very acidotic despite ventilator adjustment, head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37, she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia, consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5, pronounced dead at 2:48AM.
45 2021-02-04 tremor, tingling On January 27, 2021 at around noon I received the first dose of the Pfizer/BioNTech Covid-19 vaccine... Read more
On January 27, 2021 at around noon I received the first dose of the Pfizer/BioNTech Covid-19 vaccine. After approximately 10-15 minutes I noticed a reaction. I was really lightheaded , short of breath, and shaking. It felt like I was going to pass out. I was given water and a bar to eat, and eventually I got to a place where I felt that I could drive. I went for a walk with a couple of friends, but was having a hard time walking because of shortness of breath, and was still lightheaded plus I had skin tingling on both sides of my face. I ate something afterward the walk and felt better within an hour. The next day I seemed to be fine, but then Friday (two days after the shot) I became increasingly lightheaded/dizzy and nauseous. Additionally, I had issues on Friday and Saturday with anxiety and trying to hold off mild panic attacks plus depression and nausea. I was still lightheaded/dizzy and had shortness of breath for a week after the shot. which has extend to today (February 5, 2021), over a week after the shot.
45 2021-02-05 weakness 15 minutes after the injection I started getting a scratchy throat.. which lead to my throat, tongue... Read more
15 minutes after the injection I started getting a scratchy throat.. which lead to my throat, tongue, lips tingling and burning. After a couple hours my nose felt numb and tingly inside and stayed like that until the day after. The day after i had the vaccine if I try to eat it flairs the burning fizzing feeling in my mouth and lips again. Feel week and tired, headaches and body pain. Im concerned with the mouth stuff though before getting the second dose.
45 2021-02-05 feeling hot Patient felt nauseated and hot. Laid down and given water. About 10 minutes later, patient had cl... Read more
Patient felt nauseated and hot. Laid down and given water. About 10 minutes later, patient had clear emesis (small amount). Patient sat up and cool cloth applied to face and neck. Felt cooler and said she has a hx of cyclic nausea/vomiting. She was resting and cool cloth applied again to face. Sipped some water. After total of 40 minutes of observation, patient felt better and declined further evaluation in the ED.
45 2021-02-05 pain in extremity L arm pain. L sided lymphadenopathy anterior cervical, supraclavicular
45 2021-02-06 flushing 1640 Red palms, flushed, arms itch hx sensitive skin feels throat full. denies, dysphagia or dyspnea... Read more
1640 Red palms, flushed, arms itch hx sensitive skin feels throat full. denies, dysphagia or dyspnea. Benadryl 25mg po. 1645 Vital signs 160/100,97%,76. 1655 D/C amb. without problems.
45 2021-02-07 feeling hot fatigue; chills; fever (about 99-100F); the site of injection is sore; a moving painful lump near le... Read more
fatigue; chills; fever (about 99-100F); the site of injection is sore; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; This is a spontaneous report from a contactable other health professional reported for herself. This 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9031) via an unspecified route of administration on 19Jan2021 at 09:15 AM at single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history and concomitant medications were reported as none. Allergies to medications, food, or other products was reported as none. The patient previously received the first dose of BNT162B2 (Lot number EH9899) on 30Dec2020 at 11:15 AM at single dose in left arm for COVID-19 immunisation and had no symptoms; Influenza vaccine on 10Dec2020 for immunization. The patient experienced fatigue, chills followed by fever (about 99-100F) lasted for about one and half days. The site of injection is sore even after 3 days. The patient observed a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch. The events onset date was reported as 21Jan2021. The events were reported as non-serious. The patient was not diagnosed with COVID-19 Prior to vaccination and not tested for COVID-19 since the vaccination. The patient received no treatment. The outcome of the events was not resolved.
45 2021-02-07 feeling jittery Day1: swelling in axillary and clavicle lymph nodes Day 2: lymph nodes near breast tender and swoll... Read more
Day1: swelling in axillary and clavicle lymph nodes Day 2: lymph nodes near breast tender and swollen Day 3: brain fog, feeling jittery, chills, fever 100.2
45 2021-02-07 migraine Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Cl... Read more
Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Client reports taking Benadryl all evening long. Client reports 3 days later having migraines, nausea, head ache and not feeling well. Day 3 pulse dropped in the 40's which is abnormal. Denies trouble breathing. Client reports had similar symptoms of migraines but not additional symptoms.
45 2021-02-07 pain in extremity, weakness Tired; Feel bad; Weak; Sore arm; Fever 100.3; This is a spontaneous report from a contactable consum... Read more
Tired; Feel bad; Weak; Sore arm; Fever 100.3; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: unknown; reason why batch/lot was unknown: misplaced/discarded) via an unspecified route of administration at left arm on 21Jan2021 09:45 AM at a single dose for COVID-19 immunization. Medical history included anxiety, high blood pressure (HBP). Since Covid - short of breath still racing heart. Allergies to medications, food, or other products included penicillin and apple juice. Prior to vaccination, the patient was diagnosed with COVID-19 (short of breath still racing heart). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included niacin, lisinopril, venlafaxine and montluskat for allergy. Facility where the most recent COVID-19 vaccine was administered was at public health clinic/veterans administration facility. The patient was not pregnant at the time of vaccination. The patient experienced adverse events included tired, feel bad/weak, sore arm, fever 100.3; with start date on 22Jan2021 at 03:00 PM. The events were reported as non-serious. The outcome of events was resolving. Treatment Tylenol received for fever. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
45 2021-02-07 tingling swelling on the left side of her jaw and throat began to swell/swelling on left side of face and thr... Read more
swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat; Tingling; swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw; felt a funny sensation in her throat and face/still not feeling herself; soreness; left arm was sore; throat still feels funny; feels scratchy; feeling fatigued; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old female patient started to receive bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EH9899, exp date 31Mar2021), via an unspecified route of administration in the left arm, on 15Jan2021 at 14:30, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced left arm was sore on 16Jan2021 with outcome of recovered, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat on 18Jan2021 with outcome of recovering, tingling on 18Jan2021 with outcome of recovering, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw on 18Jan2021 with outcome of recovering, felt a funny sensation in her throat and face/still not feeling herself on 18Jan2021 with outcome of not recovered, feeling fatigued in Jan2021 with outcome of not recovered, soreness on 16Jan2021 with outcome of recovering, throat still feels funny; feels scratchy on Jan2021 with outcome of not recovered. The patient visited the emergency room for left arm was sore, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat, tingling, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw. The patient was treated in the emergency room with prednisone, Benadryl and acid medicine for her stomach.
45 2021-02-08 migraine Feeling ill and tired went to sleep 3:30pm. Could not focus to read text or email. Memory issues wit... Read more
Feeling ill and tired went to sleep 3:30pm. Could not focus to read text or email. Memory issues with dizziness. 19 days since and improving but memory and focusing occasionally an issue. Dizziness stopped on day 16. Had one of the worst migraines on about day 10.
45 2021-02-09 weakness, tremor tremors temp of 104.9 rash pain all over and little zings weak shaking immune system issues
45 2021-02-09 weakness fever; chills; weakness; rash all over the body; sob; This is a spontaneous report from a contactabl... Read more
fever; chills; weakness; rash all over the body; sob; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in arm left on 04Jan2021 08:45 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included asthma, obesity. Concomitant medication included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), macrogol 3350 (MIRALAX), montelukast sodium (SINGULAIR). The patient previously took cefalexin (KEFLEX) and experienced Known allergies: Keflex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 01:30 PM Intramuscular in right arm for COVID-19 immunization. The patient experienced fever, chills, weakness, rash all over the body, sob all on 04Jan2021 12:00 with outcome of recovered in Jan2021. No treatment was received. Information on the Batch/Lot number has been requested.
45 2021-02-09 burning sensation, speech disorder I received Pfizer dose #1 on 1/13/21 with no AE. I received Pfizer dose #2 on Mon 2/1/21. On Wed ... Read more
I received Pfizer dose #1 on 1/13/21 with no AE. I received Pfizer dose #2 on Mon 2/1/21. On Wed 2/3/21, I awoke with hives on my neck and chest, I took a Clarinex. The hives progressed t/o the day. I took a Benadryl that evening. I had difficulty sleeping d/t the burning and itching. I took another Benadryl at 0130 on 2/4/21. By 0930 on 2/4/21 my entire torso and scalp was inflamed. My shoulders were swollen. I had difficulty swallowing. I had a sudden "brain fog" with difficulty speaking and a major headache. I took another Benadryl. I then slept for 21 hours with a half hour awake period for lunch and scheduled Benadryl every 6 hours. My PCP recommended Pepcid 20 mg po BID x 5 days so I started that as well, and I took tylenol for the headache. The next day my rash had improved. I was tired but not extremely fatigued like the day prior. I gradually felt better t/o the day. Saturday 2/6/21, I awoke with resolution of all s/s.
45 2021-02-09 numbness, tingling Dizziness; tingling up neck and right-side of face; numbness sensation on right brow, eyelids and ch... Read more
Dizziness; tingling up neck and right-side of face; numbness sensation on right brow, eyelids and cheek/intermittent numbness; headache; This is a spontaneous report from a contactable Other HCP. A 45-year-old female no pregnant patient received , at hospital , the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL8982 on 21Jan2021 15:15 at SINGLE DOSE for covid-19 immunisation . Medical history included diabetes .Concomitant medication included metformin (METFORMIN), glyburide (GLYBURIDE), sitagliptin phosphate (JANUVIA ).The patient previously took codeine and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity, cortisone and experienced adverse reaction. On 21Jan2021 at 15:30 the patient experienced Dizziness, tingling up neck and rightside of face, numbness sensation on right brow, eyelids and cheek. 2 hours later teeth chattering for hour and half, headache for 4 days, intermittent numbness for 3 days.Outcome of the events was reported as recovered with sequel. No COVID prior vaccination, No COVID tested post vaccination
45 2021-02-09 numbness Numbness to face, and left arm; headache; This is a spontaneous report from a contactable nurse (pat... Read more
Numbness to face, and left arm; headache; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm,on 24Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. Medical history included sulfa drug allergy, artificial heart valve (replacement) and HTN (hypertension). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included warfarin sodium (COUMADIN), lisinopril and metoprolol. The patient previously took omnicef [cefdinir] and experienced allergies. On 24Jan2021 11:15, the patient experienced headache and numbness to face and left arm. The outcome of events was recovering. Therapeutic measures taken as result of the events includes Benadryl. Follow-up attempts are completed. The following information on the batch number has been requested.
45 2021-02-10 flushing Tingling of tongue and lips; Tingling of tongue and lips; Swelling of cheeks; face turned flush; ras... Read more
Tingling of tongue and lips; Tingling of tongue and lips; Swelling of cheeks; face turned flush; rash on neck and upper chest area; This is a spontaneous report from a contactable consumer (patient) This 45-years old no pregnant female consumer received the firs dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL3247 on 21Jan2021 04:45 at left arm at single dose for Covid-19 immunization. Medical history included:allergies to medications, food or other products and high blood pressure .The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered:Other.On 21Jan2021 17:00 the patient developed Tingling of tongue and lips, Swelling of cheeks, face turned flush, rash on neck and upper chest area.The patient was treated with Benadryl. Events was reported as non serious .Outcome of the events was recovering. No Prior to vaccination, was the patient diagnosed with COVID-19. No Since the vaccination, has the patient been tested for COVID-19.
45 2021-02-10 pain in extremity Severe pain all down my right arm into hand and up into jaw and severe headache on right side behind... Read more
Severe pain all down my right arm into hand and up into jaw and severe headache on right side behind me eye, moderate chills, mild nausea maybe due to the pain. Symptoms started 2/10/21 at 6pm and progressively got worse to the point of being unable to sleep. Took Tylenol at 1:30am and the pain decreased and was able to sleep some, 4 hrs later symptoms returned. Took more Tylenol. 2/11/21 5:57pm still have mild sore arm, mild headache off and on and mild chills.
45 2021-02-10 tingling Pain at injection site, muscle/body aches, chills, prickly skin, headache, nausea & fatigue.
45 2021-02-10 tenderness Left arm felt heavy a couple hours after second COVID vaccine. By evening she had tenderness to left... Read more
Left arm felt heavy a couple hours after second COVID vaccine. By evening she had tenderness to left axilla. In am on 2/10/21 she could not move left arm due to swelling and pain in lymph nodes. Woke up 2/11/21 and still couldn't move arm due to discomfort. Also developed a runny nose, slight upper abdominal pain, and slight headache.
45 2021-02-11 numbness, pain in extremity, feeling cold Heart palpitations, cold/numb face half hour after vaccination. Sore arm 2/5/21. Woke up feeling lik... Read more
Heart palpitations, cold/numb face half hour after vaccination. Sore arm 2/5/21. Woke up feeling like I slept wrong and pulled muscles in my back 2/8/21. Shortness of breath, sore back and chest, left side, hard time getting comfortable going to sleep, 2/9/21. Condition spread to left chest during the day, wondered if I was having a silent heart attack, very difficult time getting to sleep, felt like I had a cracked ribs, back left, 2/10/21. Pain grows to include right side of chest and back, lungs feel like they can't get filled deeply without pain, sleeping pain shifts to right side, 2/11/21. Yearly gyno appt, Dr said lungs and heart sound good, likely side effects of vaccine. Cracked ribs sensation moves to right side of back, difficulty getting comfortable, woke up several times from discomfort, 2/11/21. Shortness of breath and pain breathing during the day, 2/12/21
45 2021-02-11 muscle spasms I received the vaccine at 5:00pm on Feb 4. In the middle of the night around 3:00am I was woken up b... Read more
I received the vaccine at 5:00pm on Feb 4. In the middle of the night around 3:00am I was woken up by intense lower back pain. Over the course of the next 48 hours the pain increased with terrible spasms where I was rendered incapacitated. In the days following, continuing to today, (February 12th) , my back remains in pain, but to a lesser degree, allowing me to be functional while consistently uncomfortable. As I mentioned before, in 2017 I had the LAP flap reconstructive surgery. The area of my pain is around the incisional site of my surgery. The pain was similar to how I felt post surgery. While I accept that this could be a strange coincidence, it is important to note, that since recovering from my surgery, I have not suffered any meaningful back pain.
45 2021-02-12 bell's palsy I received the Covid vaccine on 1/28/21- and had been completely healthy. But 5 days later on 2/2/2... Read more
I received the Covid vaccine on 1/28/21- and had been completely healthy. But 5 days later on 2/2/2021- the LEFT side of my face was no longer moving the same as the right side of my face. I went to the mirror and noticed that I couldn't smile, couldn't raise my eyebrows , couldn't close my eyes shut... and realized that i was experiencing a BELLS PALSY. I called the doctor and got a prescription for Prednisone and Valacyclovir. that same day. The next day 2/3/21.. I got in to see the neurologist who confirmed the diagnosis and asked that I get an MRI of the brain and start physical therapy on my face due to facial memory loss-- which I did the next day 2/4/2021. The hardest part of this facial paralysis has been my eye- which continuously runs and burns- so much so that the neurologist sent me to a cornea specialist- whom I saw the next day on 2/5/21. I was instructed to tape the eye down to prevent severe dry eye and allow eye to rest. I have been going to PT now twice a week since then, taping my left eye and completing massage exercises at home as i was told.
45 2021-02-12 hot flush Vertigo lasting five days and Hot flashes
45 2021-02-12 pain in extremity Only had sore arm with each dose but 3 weeks later lost my hearing overnight in my left ear. Profoun... Read more
Only had sore arm with each dose but 3 weeks later lost my hearing overnight in my left ear. Profound deafness on audio gram.
45 2021-02-14 discomfort, pain in extremity, tingling passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of ba... Read more
passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021. No follow-up attempts are possible. No further information is expected.
45 2021-02-14 feeling hot, flushing Vaccine administered at 1727. Patient reported reaction to influenza vaccine in 2019. Patient advise... Read more
Vaccine administered at 1727. Patient reported reaction to influenza vaccine in 2019. Patient advised to wait 30 minutes while being supervised. Reaction noted to start at 1736. Patient reported "Fire feeling" and "Tingling on my tongue." Blood pressure in right arm 190/78. Heart rate 85-90's, oxygen saturation level 98% on room air, and respirations 20 breaths per minute. Patient reported dry mouth and hot sensation. Cheeks and chest flush. Patient denied shortness of breath and swelling of the mouth and tongue. Patient reported "Could be a panic attack." Educated on importance of deep breathing. Exercise completed. Bottle of water provided. Benadryl offered and patient declined at this time. 1742: "Fire feeling" began to resolve. 1756: Blood pressure in right arm 160/80. Heart rate 81 and oxygen saturation level 97% on room air. Respirations 16 breaths per minute. Temporal temperature 98.6 degrees F. Patient reports headache in frontal region.
45 2021-02-14 numbness I exp headaches, shoulder aches and really bad nausea. The headache from dose 2 was worse than first... Read more
I exp headaches, shoulder aches and really bad nausea. The headache from dose 2 was worse than first dose. I also exp numbness(limp feeling) bilateral arms. I was unable to cook had to be in bed for 2 days.
45 2021-02-14 pain in extremity, tingling stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like n... Read more
stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like nausea; tongue was tingling a little bit; whole body was tingling; headache; her tongue feels like it is tingling and dry; has pain in her right hand since she got the vaccine dose in her right upper arm; feeling a little bit febrile, her temperature was 99 degrees Fahrenheit; This is a spontaneous report from contactable consumers. A 45-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EC1283, via an unspecified route of administration in the right arm, on 24Jan2021 17:00 at SINGLE DOSE for covid-19 immunization. Medical history included blood pressure, and on birth control. She recently started taking the blood pressure medication (lisinopril) three months ago her blood pressure was due to a lot of stress, and she was not feeling good she had her doctor to see her blood pressure her doctor then put her on this (lisinopril). She stated that she took Lisinopril 5mg at night last night as well as took her birth control pill. Concomitant medication included lisinopril for blood pressure; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), pantoprazole and an unspecified flu shot injection to arm in October (year not specified; she takes the flu shot every year). The patient received BNT162B2 on an unspecified date for covid-19 immunization; on the first dose of COVID-19 vaccine, she felt nothing, just a little tired and she had pain in her left hand. However, it was different for the second dose. Fifteen (15) minutes after getting her second dose of vaccine, the patient was fine. Then after 30 minutes, she came home and felt like her whole body was tingling, and her tongue was tingling a little bit. She says she did drink some water. She did no treatment other than drink some water and take and hold breath in and out, holding her breath a little bit. She says her body was tingling for just a second, that is gone, her tongue feels like it is tingling and dry, kind of like when you taste something spicy a little bit, that kind of experience. She says that it lasted like 1- 2 hours yesterday and it is not going, she still feels it a little bit on her tongue, the rest of her body is not tingling. She also experienced headache and has pain in her right hand since she got the vaccine dose in her right upper arm. Today(25Jan2021), she was feeling very tired, her heart rate was a little higher, like 95, and she was feeling something like nausea, her stomach was a little upset today, and she was feeling a little bit febrile, her temperature was 99 degrees Fahrenheit when she took it. Outcome of events was reported as 'unknown'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
45 2021-02-14 tingling 0930 R arm tingling. BP 142/88, HR 83, lung clear equal, )2 99, HR 83 RR 14. 0940 had some water, ... Read more
0930 R arm tingling. BP 142/88, HR 83, lung clear equal, )2 99, HR 83 RR 14. 0940 had some water, 0945 had some snacks. Pt c/o sleeping deprived. No Health Hx, no medications, last physical on 10/20, no surgeries. Pt was prescribed Norvasc but currently not taking. Pt was advised to call PCP to follow up and if the symptoms worsen to call 911. 1005 HR 75, good pulse RR 18, lungs clear & equal. BP 140/90. 1010 Pt feeling better, called the ride. 1016 Pt stated she is going home and eat. 1020 Pt's ride got to the building to pick her up. This RN walked the pt. The pt stated she was feeling much better and was going to call PCP asap.
45 2021-02-15 pain in extremity Sore arm, chills, fever, muscle aches, headache, fatigue for 48 + hours
45 2021-02-16 weakness, numbness developed left side facial numbness and weakness, head pressure, neck pain near base of skull, chill... Read more
developed left side facial numbness and weakness, head pressure, neck pain near base of skull, chills, and aches
45 2021-02-16 burning sensation Extreme dizziness to the point of not being able to stand, nausea, vomiting, elevated blood pressure... Read more
Extreme dizziness to the point of not being able to stand, nausea, vomiting, elevated blood pressure, chills, burning heavy ness in chest, fatigue. Nausea, dizziness and fatigue for over 2 weeks after 2nd shot.
45 2021-02-16 discomfort, tenderness After receiving the vaccine, I experienced moderate arm pain at the site of injection within 2 minut... Read more
After receiving the vaccine, I experienced moderate arm pain at the site of injection within 2 minutes. Almost 7 hours later and the pain has increased to the surrounding area in an approximate 2" radius around the site of injection. I am also experiencing a lymphatic response, mostly felt in my neck, and also have some muscle soreness in my neck. I also experienced a few PVCs...I was diagnosed 4 years ago with heart arrhythmia that was mitigated through reduction of stress and caffeine. So, I don't consider it to be a "chronic" condition and it is not something I normally experience, but I have felt a few PVCs happen since being vaccinated today along with some very mild heart pain that is just beginning. For treatment of muscle soreness at injection site, I am just applying a bit of ice. For lymph nodes, I've been doing some lymphatic exercises and trying to not to sit too much. I also have a little bit of headache that is just developing. These symptoms are mildly uncomfortable over all. The arm tenderness does give me a general feeling of discomfort and limits my desire for movement, but does not seem to impede my ability to move. For headache, I would normally take a 400 mg of ibuprofen, but I'm not going to take any kind of NSAID at this time. I will monitor my heart but am not concerned. I cannot be certain the vaccine is the cause of any of these symptoms, except for the arm tenderness and probably the lymphatic response as well. Headache and PVCs can be caused by a lack of sleep and possible dehydration, and I've had a bit more caffeine than I normally might.
45 2021-02-16 slurring shortness of breath, light headed/dizziness, tingling of lips and tongue, felt as if tongue swelling... Read more
shortness of breath, light headed/dizziness, tingling of lips and tongue, felt as if tongue swelling, difficulty swallowing and speaking, nausea, numbness of lips
45 2021-02-16 numbness, tingling Patient had numbness and tingling in left hand and fingers. Held patient for an additional 15 minute... Read more
Patient had numbness and tingling in left hand and fingers. Held patient for an additional 15 minutes and symptoms got worse. Staff took vitals BP: 152/107 and pulse: 75. Patient taken to ER for examination via wheelchair. At ER, pt stated that after receiving her first dose of the COVID vaccine, she the fingers of her left hand became tingly and then blood pressure became elevated while at the clinic. Patient stated she does have a history of anxiety and that taking shots does make her nervous and upset. She does have Xanax at home that she can take but she has not taken any today. She also does have a history of high blood pressure and does have high blood pressure medicine which she did take today. Pt discharged home, with instructions to follow up with primary care provider, return to clinic in 4 days if no better, or return sooner to clinic/ER if worsening symptoms. 1/29/21: Pt received the 2nd dose of vaccine with no issue.
45 2021-02-16 migraine Pt completed 2 dose of COVID 19 (Pfizer) vaccine. She did not develop any side effects after her fir... Read more
Pt completed 2 dose of COVID 19 (Pfizer) vaccine. She did not develop any side effects after her first dose, but developed acute on chronic migraine HA, nausea, low grade fever, and back pain after her 2nd shot. On the day of the 2nd shot (01/29/21), she did not have any symptoms, but woke up the next day (1/30/21) with symptoms. Her symptoms persisted after more than one week.
45 2021-02-16 muscle spasms Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a co... Read more
Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 45-year-old) on 13Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included penicillin allergy. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Jan2021 at 06:00 PM patient experienced nausea, vomiting, shortness of breath, fainting and hand spasms. Events resulted in Emergency room/department or urgent care. Patient was treated at emergency room (ER) with diphenhydramine hydrochloride (BENADRYL), Steroid and Anti nausea. Patient was not tested for Covid post vaccination. Patient recovered on unknown date in 2021 from the reported events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
45 2021-02-16 pain in extremity 12 hours after vaccination, i experienced chills, fever, headache and very sore arm. My teeth were c... Read more
12 hours after vaccination, i experienced chills, fever, headache and very sore arm. My teeth were chattering and I was shivering. Symptoms last for next 72 hours but were on and off. This happened too when I got my 1st dose.
45 2021-02-17 feeling hot, flushing Patient began feeling hot, "head pounding", facial flushing, and developed red rash all over her an... Read more
Patient began feeling hot, "head pounding", facial flushing, and developed red rash all over her anterior chest wall. She was then transferred to the medical evaluation area and examined. She was evaluated and given Benadryl 25mg . Her vitals were within normal limits. A few minutes after taking Benadryl, her symptoms started to diminish and she was no longer feeling flushed or having pounding in her head. The rashes on her anterior chest wall remained. Patient denies any any shortness of breath, chest pain, wheezing, or having tingling in her tongue or lips. Her vitals within normal limits. Patient felt stable upon leaving the facility and advised to follow up with her PCP and an allergist for further care. Patient refusing to be transferred and evaluated by ER facility
45 2021-02-17 night sweats, numbness Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection;... Read more
Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection; itching on body on the side on injection; dizziness; insomnia; night sweats; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown, unable to locate or read details), via an unspecified route of administration on 23Jan2021 16:15 (04:15 PM) at single dose on right arm for COVID-19 immunization. Patient was not pregnant at the time of report. The patient medical history was not reported. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included fluticasone, salmeterol, montelukast and paracetamol (TYLENOL). Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The most recent COVID-19 vaccine was administered in School or Student Health Clinic The patient experienced abdominal pain, severe nausea, headache, numbness in hand, itching on body on the side on injection, dizziness, insomnia, night sweats, low grade fever, all on 24Jan2021 02:00. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovering. Patient has not been tested with COVID-19 since the vaccination. Information on the lot/batch number has been requested.
45 2021-02-17 pain in extremity, nerve pain The next day I had a low grade fever. The highest was 100.9. I took Aleve for my period cramps and T... Read more
The next day I had a low grade fever. The highest was 100.9. I took Aleve for my period cramps and Tylenol around 2pm. Around midnight I took Motrin, 600mg. The next morning, my temp was normal. I then had back and arm pain. The arm pain was like a nerve pain. I called my PCP on the 11th. Dr. said she thought it was idiopathic brachial plexopathy. She prescribed Prednisone at 50mg and tapered down over 4 weeks. I had an MRI of my brachial plexus and that showed inflammation. I rested my arm for 4 weeks and then I started physical therapy this week. I will be seeing another neurologist next week that specializes in neuromuscular disorders. He might order a nerve study.
45 2021-02-17 tingling tingling arm and face
45 2021-02-18 difficulty speaking, inability to speak Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlyi... Read more
Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlying issue. She stayed for 30-45 minutes and started coughing and then lost her voice, her throat started itching and she could not speak she was very hoarse, her skin turned real dark and she went to the hospital, they gave her an EPI pen, Prednisone 40mg for 4 days, Albuteral was given, Solumedrol and Peptin, and benedryl, Ivciartin, She continues to have a deep hoarseness.
45 2021-02-18 numbness at the time of initial assessment, patient does not have hives and is 98 to 99% on room air. She do... Read more
at the time of initial assessment, patient does not have hives and is 98 to 99% on room air. She does report a sensation of feeling like difficulty breathing or swallowing and is initially treated with Solu-Medrol and Benadryl as well as IV fluids. She reports that symptoms are improving almost immediately after meds are pushed. As result epinephrine is initially deferred for continued monitoring. However upon reassessment approximately 1 hour after reported reaction, the numbness in the hands and feet have resolved, but she is complaining that she feels as though the back of her tongue is swollen and still making it difficult to swallow though she no longer feels short of breath. As a result, we have discussed the possibility of treatment with epinephrine in order to fully resolve symptoms, and she is agreeable to proceed. ,
45 2021-02-18 pain in extremity Wednesday, day of vaccine, soreness in arm, started out feeling bruised then progressed to stiffness... Read more
Wednesday, day of vaccine, soreness in arm, started out feeling bruised then progressed to stiffness and pain in my shoulder joint. Thursday my whole body ached, especially my knees and hips, I felt feverish. Thursday night a severe headache developed and persisted through Saturday morning. ibuprophen and acetemetiphine did nothing to relieve any of the symptoms.
45 2021-02-19 cold sweat, pain in extremity I had a sore arm and a slight headache the day after the Pfizer injection. I went out to the grocery... Read more
I had a sore arm and a slight headache the day after the Pfizer injection. I went out to the grocery and had a total panic attack. I had to leave the store. It took amazing effort to do this. I then had to sit in my car for an hour and talk to a friend to de-escilate enough to drive home. I have spent the entire week very close to my bed. Even getting up and taking a shower causes me to panic- heart rate increase, shallow breathing, cold sweat, the feeling that I am coming out of my body or will pass out. All I have been doing is laying around for one week?s time. I have anxiety but nothing like this. I do not know if I should take the second injection. I am fearful that this will be so much worse after taking the second injection. I did call my PCP and the nurse did a phone review with me telling me that I should take the second injection and that anxiety / panic attacks are not a known side affect of this injection.
45 2021-02-19 feeling hot While sitting in the waiting area I began to feel itchy. it was around 7:50am. I quickly took 2 chew... Read more
While sitting in the waiting area I began to feel itchy. it was around 7:50am. I quickly took 2 chewable (12.5mg each) benadryl tablets. after about 5 min. i felt stable enough to leave. on the way home I started to feel the itching intensify and I felt very warm. I had welts forming and hives appeared all over. As I pulled into my driveway( 7 min drive from vaccination site) I felt my lips and eyelids swell, and my throat felt tingly. I took another 2 chewable benadryls. (12.5mg each). I immediately called my Doctor and explained what was going on. I also started to wheeze. I used my inhaler. He told me to use my epipen. Which I already had prepared since I knew this was anaphylaxis. I started to feel stable enough to go inside. I called my husband to come downstairs to be with me. I still wasnt feeling well and the tightness and wheezing persisted. At around 8:40, My dr. told me to use the 2nd Epipen and use my nebulaizer. If I wasn't better in 10 minutes he would call an ambulance. Thank GD the itching and hives subsided and the wheezing and tightness diminished by aroung 8:50am. My dr. comtinued to monitor me and check up on me. By 3pm I was back to myself.
45 2021-02-21 feeling hot Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), ... Read more
Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), sweating and heat episodes (heat feels like it's emanating from from my neck/shoulder area). Additional SE's: pain at injection site, fatigue. Quasi-dissociative feeling resolved after fever stopped. At this writing, still having sweating episodes, pain diminished considerably, fatigue waxing and waning.
45 2021-02-21 pain in extremity Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-da... Read more
Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-day 3. Chills-day 4.
45 2021-02-22 impaired body coordination Nausea, vertigo, ataxia, falls, change in vision persisting currently
45 2021-02-23 burning sensation burning sensation in her right arm (not where she received the shot); This is a spontaneous report f... Read more
burning sensation in her right arm (not where she received the shot); This is a spontaneous report from a contactable consumer reporting for herself. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3247/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 10:15 (at the age of 45 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included birth control pills. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Jan2021 at 23:30, the patient experienced burning sensation in her right arm (not where she received the shot) late at night, lasting for about 20minutes. The patient did not receive any treatment for these events. The event did not require hospitalization. The outcome of the event burning sensation in her right arm (not where she received the shot) was recovered on an unspecified date in Jan2021. Since the vaccination, the patient had not been tested for COVID-19.
45 2021-02-23 flushing headache, flushing, nausea , vomiting and chest pain after 2nd dose. vitals were stable with stron... Read more
headache, flushing, nausea , vomiting and chest pain after 2nd dose. vitals were stable with strong pulses pt took zofran that she brought home. encouraged rest, and fluids. provided cold compress and reassurance pt laid down in a stretcher and rested for about an hour before getting discharged home.
45 2021-02-23 hot flush hot flash sensation on right side body under her arms down side of her body; This is a spontaneous r... Read more
hot flash sensation on right side body under her arms down side of her body; This is a spontaneous report from a contactable pharmacist (patient). This 45-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3302; dose 1) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose in the arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced hot flash sensation on the right side of her body. The patient stated she got the vaccine "today" (26Jan2021) and wanted to find out if the kind of side effect she was having would resolve or if she needed to contact her physician. She had been experiencing a hot flash sensation on the right side of her body under her arms and down the side of her body on 26Jan2021. The outcome of hot flash sensation on the right side of her body was not recovered. No follow-up attempts are needed. No further information is expected.
45 2021-02-23 tingling Tingling sensation in extremities followed by an itchy rash, redness, and hives in arms, neck, face,... Read more
Tingling sensation in extremities followed by an itchy rash, redness, and hives in arms, neck, face, and chest.
45 2021-02-23 tremor Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated bloo... Read more
Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature. Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
45 2021-02-25 weakness, migraine Diarrhea, vomiting , Fever , chills, Extreme body each , Migraine, light sensitivity, weakness, Runn... Read more
Diarrhea, vomiting , Fever , chills, Extreme body each , Migraine, light sensitivity, weakness, Runny noise, lose of apatite . Extreme sweating. Extreme sweating of the under arm is still and issue. No fever now.
45 2021-02-25 weakness pain on vaccination site , unable to move arm, body aches, fever, weakness for 48 hours
45 2021-02-25 breast pain Severe swelling and pain in right arm pit, swelling in left arm pit, neck and pain in Lymph glands. ... Read more
Severe swelling and pain in right arm pit, swelling in left arm pit, neck and pain in Lymph glands. Pain under left side of breast bone and shoulder blade.
45 2021-02-25 muscle spasms Other than mild pain at the injection site on the night of 2/19/21, things were fine until Tuesday, ... Read more
Other than mild pain at the injection site on the night of 2/19/21, things were fine until Tuesday, 2/22/21 when my tongue began twitching. It is now 2/26/21 and it continues to twitch. I can eat and drink and swallow fine.
45 2021-02-25 tingling, flushing Flushing upper torso and face, tingling pins and needles skin on face and arms (more left side of fa... Read more
Flushing upper torso and face, tingling pins and needles skin on face and arms (more left side of face) and behind ears, lips stinging (this started first) tongue tingling, felt lightheaded or unsteady (pulse was up), and headache
45 2021-02-25 tingling Tingling/Pins & Needles in hands and feet.
45 2021-02-26 pain in extremity pt with dizziness and painful left arm, redness to nose and face. Benadryl 50 mg given
45 2021-02-28 weakness Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction di... Read more
Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction didn't go away until 2 hours afterwards. Puffy, itchy eyes (both eyes) with rash came and lasted about two weeks. Monday or Tuesday, I noticed a rash all over my body - red and blotchy. That went away in a day. I got chills, fever, weakness, nausea, vomiting, diarrhea and that lasted 48 hours (16th in pm-17th and got better evening of 18th). When I had the rash was all over the body, I took a Zyrtec. The weekend I was really sick I didn't take any medication. Phone visit with Doctor - January 15th - allergist - I followed up with him about the throat constriction. He just was monitoring symptoms. After the weekend that I was really sick, I told him and he ordered bloodwork.
45 2021-02-28 flushing, difficulty speaking Immediately after receiving Pfizer Covid vaccine, patient developed hoarseness and tried to clear he... Read more
Immediately after receiving Pfizer Covid vaccine, patient developed hoarseness and tried to clear her throat. She had mild flushing as well. The hoarseness was on and off for a few minutes. Pulse ox was 97-98% on room air and was given PO Pepcid 40mg and PO Benadryl 50mg while in vaccine clinic. She was transported to the ED (chief complaint recorded as "hoarseness, chest tightness, SOB, throat swelling") where she was given IV Pepcid 20mg, IV Benadryl 50mg and IV SoluMedrol 125mg. She remained on room air and vital signs remained within normal limits. The patient was monitored for 2h before discharged home. Patient was given an outpatient prescription for Medrol DosePak and Pepcid.
45 2021-03-01 weakness Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to s... Read more
Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.
45 2021-03-01 tingling pt with sensation of tingling of the right lower leg 10 min after first covid vaccination. pt denies... Read more
pt with sensation of tingling of the right lower leg 10 min after first covid vaccination. pt denies, rash, flushing, hives, chest pain, palpitation, shortness of breath, wheezing , stridor or altered mental status. symptoms resolved 40 min without intervention except observation and reassurance. pt instructed to follow up with pcp
45 2021-03-02 grand mal seizure, seizure Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousnes... Read more
Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousness lasting <15 seconds with eyes "rolling back" and skin color change from normal for age/race to pale followed by bilateral upper extremity convulsions. Witnessed by monitoring area Registered Nurse. Hx: Seizures, last seizure secondary to codeine ingestion >1 y ago. Anxiety related to injections. Timeline: 1759- Vaccinated with Pfizer Lot # EN6199 1st dose 1805- adverse reaction occurred 1806- mental status: slow to respond, skin: pale/diaphoretic, VS: HR 51 (regular at the radial site), BP 80/palp, RR: 12, T: 36.8, Spo2 100% on RA 1807- 911 activated, placed in position of comfort. 1815- EMS arrived, EKG consistent with sinus bradycardia, HR 58, BP 150/130, RR 15, Spo2 100% on RA 1820- EMS placed patient on gurney. 1825- Departed via EMS gurney
45 2021-03-02 pain in extremity Severe headache and fatigue, lasted about 6 hours. Have had several headaches throughout the followi... Read more
Severe headache and fatigue, lasted about 6 hours. Have had several headaches throughout the following days but not a severe as first one. Sore arm and elbow
45 2021-03-02 tenderness increased swelling and redness and neck tenderness and pain
45 2021-03-03 flushing Tingling and numbness in the face particularly around the mouth. Started 15 minutes after vaccinati... Read more
Tingling and numbness in the face particularly around the mouth. Started 15 minutes after vaccination and continues now 6 days later. Does not seem to have abated at all. Face feels flushed all the time.
45 2021-03-03 muscle spasms extreme muscle cramps in both legs; This is a spontaneous report from a contactable consumer (patien... Read more
extreme muscle cramps in both legs; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at the left arm on 21Jan2021 15:00 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included magnesium, cannabidiol, and docusate sodium (COLACE). The patient experienced extreme muscle cramps in both legs on an unspecified date after the first shot. The patient underwent lab tests and procedures which included nasal swab: negative both on 15Feb2021 and 16Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the event was recovering.
45 2021-03-03 pain in extremity, migraine I had a sore arm, migraine headache and extreme fatigue.
45 2021-03-04 burning sensation rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This ... Read more
rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3249), via an unspecified route of administration in the left arm, on 25Jan2021 at 15:30 (at the age of 45-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib), tachycardia, and allergy to proton pump inhibitors. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included metoprolol tartrate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231) on 04Jan2021 at 11:00 (at the age of 45-years-old) in the left arm for COVID-19 immunization. The patient experienced body aches and fever of 102.7 on 26Jan2021, left ear pain in Jan2021, intense burning and intense dizziness on 01Feb2021, and rash and shingles on 02Feb2021. The events were reported as non-serious. The clinical course was reported as follows: The day after the vaccination, 26Jan2021, the patient had body aches intermittently (reported as: not bad) and then spiked a fever of 102.7 the evening of 26Jan2021. The pain (per family recollection: complains of left ear pain) started about 28Jan2021 or 29Jan2021, but intense burning, pain, and intense dizziness started on 01Feb2021 with diagnosis of rash and shingles on 02Feb2021. Therapeutic measures were taken as a result of all of the events, which included valacyclovir (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of body aches, fever, left ear pain, intense burning, intense dizziness, rash, and shingles was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
45 2021-03-04 night sweats, burning sensation Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats a... Read more
Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats and burning; All night woke up with sweats and burning; All night woke up with sweats and burning; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 20Feb2021 08:30 at single dose for covid-19 immunization. Medical history included Vasovagal synchope, allergy to Sulfa drugs. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), metoprolol. The patient previously allergy to cipro and levaquin. The patient previously received the first dose of bnt162b2 (Lot number unknown), at the age of 45-year-old, via an unspecified route of administration in left arm on 28Jan2021 15:30 at single dose for covid-19 immunization. About 11 hours after 2nd dose (20Feb2021 19: 30), the patient got extreme chills and fever, headache and body aches. All night woke up with sweats and burning. Fainted around 21Feb2021 06:00 (patient had vasovagal synchope so maybe aggravated it). No treatment received. The patient was no pregnant. The outcome of the events was recovering. Information on the lot/batch number has been requested.
45 2021-03-04 pain in extremity Instantly had a Metal taste in mouth and buzzing tongue. Later I had a very sore arm and throat. The... Read more
Instantly had a Metal taste in mouth and buzzing tongue. Later I had a very sore arm and throat. Then the next day I had a headache, upset stomach, chills and a was achy.
45 2021-03-04 pain in extremity Initial soreness in left arm deltoid muscle lasted about 2 days. Then a few days after that there wa... Read more
Initial soreness in left arm deltoid muscle lasted about 2 days. Then a few days after that there was muscle weakness and soreness when I tried to use my left deltoid muscle. Pain and weakness has yet to go away and it?s been 2 months.
45 2021-03-04 tenderness Swollen and very tender/sensitive knuckles in fingers. Painful. Excessive swelling to the point that... Read more
Swollen and very tender/sensitive knuckles in fingers. Painful. Excessive swelling to the point that wedding band doesn?t even come close to fitting on finger (which has been worn for 15 years).
45 2021-03-05 flushing While in observation period, pt reported feeling lightheaded and flushing, 12 minutes post-vaccinati... Read more
While in observation period, pt reported feeling lightheaded and flushing, 12 minutes post-vaccination. Assessed by on-site EMS. Patient reported palpitations and chest-tightness. Vital signs taken by EMS. At 1815 BP 141/88 HR 104. At 1817, BP 160/101 HR 150. HR 168 per EMS. Based on tachycardia and symptoms, decision was made to transport to ER. Patient denied any significant health history or previous vaccine adverse events. Patient transported via ambulance.
45 2021-03-05 migraine Migraine; nausea; vomiting; low grade fever; tired; chills.
45 2021-03-06 feeling hot Approximately 3 - 5 minutes after the vaccine I got a very hot feeling in my chest. I then started... Read more
Approximately 3 - 5 minutes after the vaccine I got a very hot feeling in my chest. I then started to feel lightheaded and just weird. I was taken to lay down. My blood pressure was taken and it was elevated. I don't recall the exact numbers. I then began to develop hives on my chest and neck and a few minutes later I began coughing. An ambulance was already on site. They took me in the ambulance and gave me 25 mg of Benadryl and a dose of epi. The coughing subsided for about 10 minutes then began again. I was given another 25 mg of Benadryl. At the hospital I was observed. At approximately 5:30 I began to cough again. It was decided that I needed steroids and was given steroids in my IV. Once I stopped coughing I was discharged and sent home with a prescription for steroids and an Epi-pen
45 2021-03-07 involuntary muscle movements Less than two hours after the shot was administered, I started to feel nauseous and overall not well... Read more
Less than two hours after the shot was administered, I started to feel nauseous and overall not well, along with fatigue. I had chills and remained cold for the next 14 or so hours. The worst part was the uncontrollable movements of my entire body, which started as almost a feeling of crawling inside then quickly progressed to moving. This began about 6:30 pm and lasted until almost midnight. At times, it felt like my muscles were tightening up so much that they were going to spasm. I have never experienced this and it was quite worrisome. It was what I imagine people with Parkinson's feel. I had a reaction to the first shot on 2/14/21 about 26 hours after. Severe fatigue, body aches and headache. All were terrible. Only lasted about 12 hours.
45 2021-03-07 difficulty speaking thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; S... Read more
thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; She lost her voice completely; coughing; itchy throat; very hoarse voice/her voice goes and comes; she got very dark in her face; She had an allergic reaction from the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer (patient's mother). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on the right arm on 17Feb2021 10:46 at a single dose for covid-19 immunization. The patient medical history included renal failure which she has had since 17Feb2020 and she was on dialysis which started on 04Dec2020. She had had a prior renal transplant before which was on 12Aug2004. Concomitant medications included prednisone, nifedipine (PROCARDIA [NIFEDIPINE]), clonidine, sevelamer, tacrolimus, carvedilol and repaglinide; all were taken from an unspecified date for an unspecified indication. She was on current medication for that for the renal failure. However, at the time of the vaccine her regular medication was on hold, she did not take it because she wanted to do the vaccine. The patient's mother reported that on 17Feb2021 her daughter has been having a lot of difficulty, she couldn't speak, she can't speak properly, unable to speak very clearly. She lost her voice completely/loss of voice, coughing, itchy throat, very hoarse voice, her voice goes and comes, and she got very dark in her face. The patient's mother thought that her daughter was having a stroke. The patient's mother also thought that the patient was going to die. She added that her daughter went to the ER and she still has problems and she could have died. She had an allergic reaction from the Pfizer COVID vaccine. She took the Pfizer vaccine at 10:46 AM. She can't speak now if she does it strains her voice then she was more hoarse. She said after the vaccine this occurred about 30 or 45 minutes. The patient was terrified, she was frightened because she wasn't able to speak. She had coughing, itchy throat, unable to speak clearly. The patient stated that she was dying. They had to get her to the hospital and she stayed over night for observation. She was discharged the next day, she stayed over night because they gave her medications they had to watch and take her vitals and blood work and they came back normal it was just the hoarseness but she had a bad allergic reaction. They gave her a lot of medications to go home on. She said that on 17Feb2021 she went to the hospital and she was discharged home 18 Feb2021. They were doing an EKG, a chest Xray, blood work, those test were being done to make sure her respiratory was okay. She had no swelling, no enlargement or they would have admitted her but all of that was normal and she was discharged home on 18Feb2021 on Solumedrol, Albuterol, Pepcid, Benadryl, Claritin. She had a terrible allergy. She said she was not admitted to the hospital they kept her for observation and she stayed in the emergency room for observation. They gave her an EpiPen. They discharged her home with an EpiPen and Prednisone 40 mg for 4 days. She said that the doctor said if you have an allergy, go to the nearest hospital and that was all being done. She asked what happens now because the patient was supposed to get a second dose but the patient's mother doesn't think so since the patient was terrified. The patient's mother said the vaccine was causing a lot of big allergies up there. She confirmed that it was her daughter experienced. Coughing itchy throat, loss of voice, unable to speak very clearly, and her face was very dark. She said hopefully someone will get back to her. She said the loss of voice after so many days, it has been 7 days now and her voice that way frightens the patient's mother. The outcome of the events was unknown.
45 2021-03-07 flushing Became flushed , rapid HR, nausea and syncope. Employee taken to ED where she was stable and receive... Read more
Became flushed , rapid HR, nausea and syncope. Employee taken to ED where she was stable and received IV fluids and Zofran, monitored and discharged to home.
45 2021-03-07 numbness groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have verti... Read more
groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.
45 2021-03-07 muscle twitching Involuntary twitching of right arm that lasted for 48 hours.
45 2021-03-07 pain in extremity arm hurt worse than ever; extremely exhausted; headache; controllable chills; fever of 101; This is ... Read more
arm hurt worse than ever; extremely exhausted; headache; controllable chills; fever of 101; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 02Feb2021 10:30, at single dose, for COVID-19 immunization, at a school or student health clinic. Medical history included COVID-19 (prior to vaccination) and arm hurt, both on an unknown date. The patient was not pregnant at the time of vaccination and has no allergy to medications, food, or other products. Concomitant medication included ibuprofen and vitamins. It was reported that on 02Feb2021 at 14:30, about 4 hours after getting the vaccine, the patient's arm hurt worse than ever and she was extremely exhausted. On 02Feb2021, in the middle of the night, the patient experienced headache, controllable chills and had a fever of 101. No treatment was given for the events. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was not resolved. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
45 2021-03-07 pain in extremity within hours after vaccine - noted left arm pain and reduced range of motion, reduced ability to pus... Read more
within hours after vaccine - noted left arm pain and reduced range of motion, reduced ability to push/pull with left arm - sxs still present 2 months later
45 2021-03-08 feeling cold, muscle spasms, hot flush, flushing On March 8th, I started my period 11 days early. I have 94 cycles tracked on my tracking application... Read more
On March 8th, I started my period 11 days early. I have 94 cycles tracked on my tracking application and my cycle does not deviate from 27-29 days. I had cramps and pain the 9th. the symptoms that started on 2/28 were normal: site of injection soreness, fatigue, some face flushing and flashes of hot and cold.
45 2021-03-08 tenderness Two large red blotches on upper arm. One on bicep and one on back of arm. Both sore to the touch.
45 2021-03-09 flushing I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my che... Read more
I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my cheeks were VERY flushed. I took my temperature. Though it was 98.5, that is higher than my personal 'normal' temp. I am typically 97.3-7. Checked again on my flushed cheeks to see that my face was swollen. I ran into a neighbor, though wearing a mask, she didn't see/say anything, and I felt okay enough not to bring it up. By the end of the day, swelling in my cheeks was less noticeable so I went to bed thinking I wasn't having more than a typical vaccine reaction. I woke up the next day with swollen eyelids. I've only become concerned after googling the general side effects and saw 'swelling of the face' and/or 'swollen eyelids' listed as both "common" and "when to call a doctor". My (non)fever is up and down over the past few days though I still feel flushed with more pink in my cheeks.
45 2021-03-09 tingling Client had a vasovagal reaction x 3 seconds within 5 minutes post vaccination. Hx of fainting with b... Read more
Client had a vasovagal reaction x 3 seconds within 5 minutes post vaccination. Hx of fainting with blood draws and vaccination during her college years. client stated tingly on left upper chest for just a few seconds. denies chest pain, shortness of breath or dizziness. Client vitals were take at 15:26 with spo2 97, pr 54, BP 147/62, vital #2 at 15:31 spo2 98, pr 67, BP 140/85, vitals #3 15:48 spo2 98, pr 71, bp 150/88. Client was advised to go to an urgent care/ emergency room for further monitoring. Client's son will be transporting.
45 2021-03-10 feeling hot While waiting, my left hand became hot. At the moment, I have pain in the shot area and below it.
45 2021-03-10 muscle spasms I set my timer on my phone for the 15 minuets. I had no problems or reactions what's so ever. Till... Read more
I set my timer on my phone for the 15 minuets. I had no problems or reactions what's so ever. Till I got back home. I started to walk and noticed that my left leg started to what felt like a leg cramp. It started to be mostly on my thigh and moved slightly down my left leg. It doesn't hurt, just a little bother some.
45 2021-03-10 paralysis, weakness (3/10-3/11) Fatigue, headache & body aches on day of vaccine and overnight (3/11) 12:00pm lighthead... Read more
(3/10-3/11) Fatigue, headache & body aches on day of vaccine and overnight (3/11) 12:00pm lightheadedness and fatigue (took nap) (3/11) 3:10pm overall weakness (took 99mg Potassium tablet) and sudden onset of paralysis that lasted for 1 1/2 hrs (3/11) 6:05pm still feeling fatigued and a little weak, but strong enough to get out of bed on own
45 2021-03-10 tremor I began with chills 9 hours after receiving the vaccine, which then transitioned to severe shaking a... Read more
I began with chills 9 hours after receiving the vaccine, which then transitioned to severe shaking all night. Temp was 102 at the highest, severe headache( worst ever) for 3 days. The next day I had difficulty walking and had to lean on the wall to ambulate due to lower extremity weakness which lasted 2 days and spinal pain. I missed 3 days of work due to the illness after the 2nd covid vaccine. 12/23/21 After the 1st Pfizer vaccine Lot # CJ 1685, I began with chills 6 hours later and felt like I had brain fog the whole next day, just didn't feel right.
45 2021-03-11 flushing Hives with facial flushing. No airway concerns. Received Benadryl, observed for 30 min and was disch... Read more
Hives with facial flushing. No airway concerns. Received Benadryl, observed for 30 min and was discharged home in a stable condition. BP 139/91, O2 sat 97 % RA, HR 68.
45 2021-03-11 pain in extremity Arm soreness, headache, dizzy. Signed refusal went home.
45 2021-03-11 pain in extremity The day I got the vaccine around 5PM I started feeling really tired and started having symptoms from... Read more
The day I got the vaccine around 5PM I started feeling really tired and started having symptoms from the vaccine, a really bad headache, muscle aches, temperature of 100.2F, chills, nausea and I noticed my arm hurt and then my noticed my lymph nodes under my right armpit swollen (painful - lasted about a week) all other symptoms about 2 days. I had the vaccine on a Thursday, on Friday I could not even finish my work day. The overall symptoms lasted about2 or 3 days. Consulted with PCP on the phone who suggested hot and cold compresses.
45 2021-03-12 numbness Numbness to right side of face, arm, leg
45 2021-03-12 pain in extremity Sore left arm, bruise. Very sore, swollen lymph node. Sore upper left arm. No fewer and no other co... Read more
Sore left arm, bruise. Very sore, swollen lymph node. Sore upper left arm. No fewer and no other concerns. As of 3/13/21 still slight soreness.
45 2021-03-14 migraine, hot flush In the evening I became very dizzy and vomited. In the morning at 5:00am I woke up with a severe mig... Read more
In the evening I became very dizzy and vomited. In the morning at 5:00am I woke up with a severe migraine and vomited 2 more times. Around 10:30am I ate a small amount of cereal so I could take an aspirin. I had excruciating pain, nauseous, hot flashes, chills, and sweats throughout the day and only could lie in bed in the dark and quiet. I slept on and off for almost 36 hours. The following day my migraine was gone but I was very dizzy and nauseous and did not want to eat. The third day I am finally feeling fine.
45 2021-03-14 nerve pain diagnosed with Shingles. March 4th, thought I had a pulled muscle, over the next few days, decided ... Read more
diagnosed with Shingles. March 4th, thought I had a pulled muscle, over the next few days, decided it was nerve pain and started looking into massage therapy for sciatica. A few days later hive developed and considered if it could be shingles. The next day I consulted a doctor and shingles was confirmed.
45 2021-03-14 tenderness, breast pain I had no side effects until several hours later when I went to bed and woke up at 3:00am with pain i... Read more
I had no side effects until several hours later when I went to bed and woke up at 3:00am with pain in my breast on the right side. It feels like a pulled muscle but is also in the same area as a breast tumor that was removed decades ago. My right arm and right breast are tender to the touch and I have occasional sharp pain I the breast. No feeling of lumps though.
45 2021-03-15 numbness "Patient with palpitations and numbness to both hands (fingertips) that lasted 10min after PFIZER co... Read more
"Patient with palpitations and numbness to both hands (fingertips) that lasted 10min after PFIZER covid-19 vaccine, self limited BP 110/83 O2Sat 100% pulse 80, feeling better, refused ER ,HX anxiety disorder"
45 2021-03-15 migraine No taste; Migraine; Fever; This is a spontaneous report from a non-contactable consumer (patient her... Read more
No taste; Migraine; Fever; This is a spontaneous report from a non-contactable consumer (patient herself). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), via an unspecified route of administration on 30Jan2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation in hospital. The patient's medical history was unknown. It was unknown whether the patient had allergies to medications, food, or other products or not. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), on 09Jan2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation and felt tired, lethargic all weekend. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19 since the vaccination or not. On 30Jan2021, the patient experienced no taste, fever and migraine. The patient underwent lab tests and procedures included body temperature: Fever on an unspecified date. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-03-15 pain in extremity Exactly one week after shot, I experienced pain at the injection site. Pain spread from injection si... Read more
Exactly one week after shot, I experienced pain at the injection site. Pain spread from injection site to middle of arm. Left index finger joint pain. Friday, the joint was just sore. Saturday it was swollen and very painful. Attempted compression and heat therapy unsuccessfully. Sunday pain reduced to soreness. Today pain and soreness from arm and joint have ceased. Index finger joint affected is the one above palm of hand.
45 2021-03-15 tingling, tremor Dizziness, tremors, fast heartbeat, strong tingling in fingers. Symptoms onset 30 minutes after vac... Read more
Dizziness, tremors, fast heartbeat, strong tingling in fingers. Symptoms onset 30 minutes after vaccine was administered and subsided about 2 hours later. Primary care physician suggested that skipping breakfast may have been a contributing factor (I sometimes skip breakfast; I had not eaten for about 14.5 hours at the time the vaccine was administered).
45 2021-03-15 tremor Extreme fatigue, followed by approx. 5-6 hours of Tachycardia (heart rate was continuously around 11... Read more
Extreme fatigue, followed by approx. 5-6 hours of Tachycardia (heart rate was continuously around 113/116), extreme chills with shaking ( 4 blankets on me), followed by extreme sweating for 1 hr. After that I was fine as had no other symptoms.
45 2021-03-16 feeling jittery Pt developed trouble swallowing/dry throat approx 15-20 minutes after vaccination. Denies SOB or tro... Read more
Pt developed trouble swallowing/dry throat approx 15-20 minutes after vaccination. Denies SOB or trouble breathing. Benadryl 25mg PO x 1 given, pt also took 1 puff of albuterol, throat symptoms resolved, then pt developed dizziness/jitteriness. Pt monitored and symptoms resolved. Pt discharged home with family under stable condition. Respirations unlabored and even. SpO2 100% RA BP 126/61 HR 85
45 2021-03-16 numbness This is a continuation from Dose 1 and 2 worsening symptoms pain in PIP,both elbows.I have more pai... Read more
This is a continuation from Dose 1 and 2 worsening symptoms pain in PIP,both elbows.I have more pain late at night causing me to not be able to sleep. Im exp stiffness and in the last month both hands little numb.The past week exp neck/back pain. I have had bloodwork which is has been normal. Before the vaccine I haven't had any of the symptoms.
45 2021-03-16 pain in extremity Sore arm left site started at 8 PM 3/16. Then after midnight had chills and fever and nausea, temp 1... Read more
Sore arm left site started at 8 PM 3/16. Then after midnight had chills and fever and nausea, temp 101.6 shivering, body aches, dizziness when sat up. Took Advil, slept some more Hard time sleeping. 7:45 AM 3/17 had fever 102.1 F this AM, and took Tylenol. Now temp 101.1 F.
45 2021-03-16 tingling Tingling back of throat and tip of nose. Dizzy on standing.
45 2021-03-17 facial pain Myalgia, NauseaVomiting, Tachycardia, MILD LIGHTHEADEDNESS, MILD CHEST TIGHTNESS, SHORTNESS OF BR... Read more
Myalgia, NauseaVomiting, Tachycardia, MILD LIGHTHEADEDNESS, MILD CHEST TIGHTNESS, SHORTNESS OF BREATH, MILD SCRATCHY/TIGHTENING OF THE THROAD, MILD SWELLING OF THE TONGUE, MODERATE FACIAL PAIN ALONG CHEEKBONES/JAWLINE/UPPER JAW, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative: Other Relevant History:
45 2021-03-17 flushing Face was bright red and flushed off and on fir a few hours.
45 2021-03-17 pain in extremity Development of DVT of right leg and PE of right lung. Leg pain started on Friday 01/15/21. Care so... Read more
Development of DVT of right leg and PE of right lung. Leg pain started on Friday 01/15/21. Care sought at Urgent Care on 01/18/21. Started on Eliquis 01/18/2021.
45 2021-03-17 tremor Patient presented to the ED on 3/14 11:30PM with difficulty swallowing. Patient received Pfizer vac... Read more
Patient presented to the ED on 3/14 11:30PM with difficulty swallowing. Patient received Pfizer vaccine on 3/13 at 4:30pm. Immediately afterward she had sensation of lip and tongue swelling. She was given Zyrtec and monitored by the vaccination clinic for 30 minutes. She was discharged from the clinic after improvement of systems. Lip swelling presented on 3/14 at 2:00pm and she took Zyrtec. At 10pm, patient felt sensation of swelling in throat and presented to ED. EMS gave patient 50 mg IV Benadryl. Patient discharged on prednisone. Patient re-presented to ED on 3/16. Allergic symptoms subsided, but patient complained of atypical chest pain with paliptations, tremulousness. Suspect adverse reaction prednisone. She was given cardiology referral for follow up if her symptoms persisted. She remained in normal sinus rhythm with initial sinus tachycardia. Was discharged home in stable condition and counseled to return to ED for any concerns.
45 2021-03-18 burning sensation Burning almost immediately after injection while waiting during the 15 minute observation. No immedi... Read more
Burning almost immediately after injection while waiting during the 15 minute observation. No immediate swelling. Pinching sensation at site of injection throughout evening. Due to lack of visual change within an hour or two of injection, area not further observed. Next morning, observed injection site. It was/is swollen and with a small raised, white area at the immediate injection site. Red area surrounding pinpoint injection is approximately 2 inches in diameter and the area is firm with the firmness additionally extending beyond the red area. Would not describe this as a rash. Reporting due to lack of information reported about "Covid arm" relating to Pfizer as compared to Moderna reports of same reaction.
45 2021-03-18 flushing, pain in extremity I waited at the clinic for 30 minutes, but when I left I realized that I was a bit dizzy, itchy (wit... Read more
I waited at the clinic for 30 minutes, but when I left I realized that I was a bit dizzy, itchy (without hives), and flushed. I took 50mg of Benadryl and waited in my car until I felt safe to drive again (about ten minutes). By evening, I felt like I had been punched in the left bicep. I also had some minor flu-like symptoms (muscle and join pain) that resolved with Tylenol. Today is two days after receiving the vaccine and I feel perfectly fine.
45 2021-03-18 numbness, pain in extremity Swelling in left arm down to hand and fingers. My hand and fingers went numb until I took Tylenol. L... Read more
Swelling in left arm down to hand and fingers. My hand and fingers went numb until I took Tylenol. Less than 24 hours I was in severe pain. Felt like my bones hurt. Swelling on the left side included my armpit and left side of the torso down to the waist. The pain stayed for another day. Felt like I had the flu. Swelling in the armpit and upper left torse stayed for about three weeks. Wednesday, March 17 I went to the ER for chest pains, throat tightening, pain from my shoulder to my hand on the left side.
45 2021-03-18 pain in extremity Soreness in arm. 2 hours after mild headache fatigue. Starting at 24 hours after injection through ... Read more
Soreness in arm. 2 hours after mild headache fatigue. Starting at 24 hours after injection through 40 hours after Injection headache body aches muscle tenderness exhaustion nausea.
45 2021-03-19 flushing, hot flush 1605-Pt c/o fast heart rate. Interpreter immediately with pt and nurse to translate. Husband broug... Read more
1605-Pt c/o fast heart rate. Interpreter immediately with pt and nurse to translate. Husband brought to pt. BP-142/90 with heart rate 132. Chest and face flush. Received 25 mg benadryl po. Pt stated she was feeling better. 1610-BP-124/82 with heart rate 117. 1615-Pt started c/o of heart racing again. Heart rate 130 and pt now c/o sob and headache. BP-140/84.
45 2021-03-19 pain in extremity chest pain, fatigue, headaches, chills, arms soreness, insomnia
45 2021-03-20 numbness Numb feeling on left side of face like 3 hours after the shot , and a little after left ear and left... Read more
Numb feeling on left side of face like 3 hours after the shot , and a little after left ear and left part of head . Got better on the Next morning
45 2021-03-20 nerve pain Chest discomfort (30 min after injection), Upper lip swelling (6 to 6 and a half hours after injecti... Read more
Chest discomfort (30 min after injection), Upper lip swelling (6 to 6 and a half hours after injection till 14 days after injection, sometimes subsiding with Benadryl), Feeling of right side of throat closing in (20 hours after injection, but improved with Benadryl), Red spots on upper lip together with swelling (1 day after injection till 11 days after injection, at times disappearing with Benadryl), Both lips swelling (1 to 2 weeks after injection, on and off), Headaches (most days from 2 days after injection till now, 16 days after injection), Stiffening of the back of the tongue (20 hours after injection, cured with Benadryl), Nausea (2 days after injection, every few days till 16 days after injection), Low fever (5 times, every 3 days since 3 days after injection, till 15 days after injection), Diarrhea (around every 5 days since 4 days injection), Joint pain (from 2 days after injection, continued around 6 days), Nerve pain (continuing two weeks since a few days after injection), Chills (on and off, from around 3 days after injection till 1 week after injection), Fatigue (going on 16 days since an hour after injection).
45 2021-03-20 pain in extremity VACCINE WAS NOT DILUTED CORRECTLY (WAS <1.8ML OF DILUANT) AND PT GOT CONCENTRATED DOSE OF PFIZER COV... Read more
VACCINE WAS NOT DILUTED CORRECTLY (WAS <1.8ML OF DILUANT) AND PT GOT CONCENTRATED DOSE OF PFIZER COVID VACCINE. PT HAD NO AEs 30 MIN AFTER VACCINE WAS ADMINISTERED. 2 DAYS LATER, ONLY AEs WAS SORE ARM.
45 2021-03-21 flushing, feeling hot Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in... Read more
Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in my face. Resting heart rate was as high as 140 (measured by my Apple watch) prior to seeking medical assistance. After sitting in the waiting area for 20 minutes my pulse had slowed down to 100 (my resting heart rate is typically lower-mid 60s); however, my pulse was still high and I did not feel well and had started clearing my throat with mild tightness in my throat and chest. A doctor took my blood pressure reading was 140/78, typically my blood pressure is 105/65. My throat was not visibly swollen. At about 40min the EMT hooked me up to monitor my blood pressure, oxygen, pulse. At the same time I was being hooked to the monitor, my lower lip began itching and visibly showing minor swelling as well as minor swelling and red splotches in my cheeks and forehead. My heart was initially showing PVC but returned to normal. After being monitored for about 30 minutes my adverse reactions had slowed and stabilized to be released to go home. I took antihistamines and ibuprofen.
45 2021-03-21 numbness, weakness, tingling, face paralysis Symptoms: Tingling, numbness, and weakness beginning in the lower extremities and spreading upwards ... Read more
Symptoms: Tingling, numbness, and weakness beginning in the lower extremities and spreading upwards up to and including the face. Extreme muscle weakness, difficulty walking. Symptoms similar to those previously experienced with severe allergic reaction to insect stings, for which the patient has allergies documented by bloodwork. Time course: symptoms emerged in the first 5-10 min after the injection. Sensation to the face and upper torso began to fade in one hour, however symptoms persisted until several hours into administration of prescription antihistamines. Treatment: approximately 1 hour and 15 min after the injection, the patient self-administered 25 mg hydroxyzine, every 12 hours for 3 days.
45 2021-03-21 numbness, tingling numbness/ tingling in left foot
45 2021-03-21 numbness With in 15 minutes my fingers on my left hand started going numb. I had the shot in my Right arm. B... Read more
With in 15 minutes my fingers on my left hand started going numb. I had the shot in my Right arm. By the next morning I was numb from the neck down and my vision went in my left ye and very blurry in the right eye.
45 2021-03-21 migraine, tingling soreness at injection site, massive headache that subsequently turned into a migraine and lasted for... Read more
soreness at injection site, massive headache that subsequently turned into a migraine and lasted for 3 days, extreme fatigue that lasted for 3 days, sore throat, facial tingling and sensitivity.
45 2021-03-21 tingling after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips st... Read more
after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips started to tingling, then my cheeks, then my tongue. My cheeks started to get red and a bit swollen, then my breathing was getting weird, my blood pressure rise. At that moment I agreed to go in the rescue.
45 2021-03-21 tremor, muscle spasms, pain in extremity I had leg weakness, feeling like both legs going to give out about 15 minutes after vaccine, later f... Read more
I had leg weakness, feeling like both legs going to give out about 15 minutes after vaccine, later feeling of fatigue and unwellness. Couple of days later had dysphagia, food getting stuck in throat, throat tightness, feeling of phlegm, severe leg spasms in both legs, I could see spasms/jerking through pants, then had arm and hand tremors/spasms and leg weakness/feeling of legs going to give out. I had to go to ER and then had relapse of same symptoms week later. I still have dysphagia, unable to swallow solids, food and pills stuck in throat, throat tightness, weight loss of 12lbs, leg weakness and pain, excessive fatigue.
45 2021-03-22 breast pain lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sor... Read more
lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sore throat
45 2021-03-22 discomfort, numbness My resting bpm went over a 100 for about 4-5 hours. It is usually at 68-72. drinking more water help... Read more
My resting bpm went over a 100 for about 4-5 hours. It is usually at 68-72. drinking more water helped get it to the 80-90 range. When first receiving the shot I started feeling numbness in left hand. Tingling in mouth. Altogether my left side felt weird the first hour at least.
45 2021-03-22 feeling cold, feeling hot On the day after my vaccine I was sweating all day but did not think anything of it. By the end of ... Read more
On the day after my vaccine I was sweating all day but did not think anything of it. By the end of the day I was not feeling myself, I went home and felt like I needed to rip my clothes off because I was so hot. I was sweating but freezing at the same time. I changed my clothes and went to bed. I then began freezing where I my teeth were chattering and could not get warm. I had on 3 blankets and was shaking. I fell asleep and was having hallucinations and talking to my grandparents that are deceased. I woke up not know anything but what I was told by my husband and daughter. I took my temperature and it was 104.1. I then continued to alternate between tylenol and ibuprofen for the rest of the night. I slept from 6:00 pm the night of the 12th to 10:00 am on the 13th. I still had a fever but developed a headache that nothing was helping. my fever was 101.4. I was told to go to the doctors to get checked by my job which I did, they examined me and the next day I went back for a COVID swab. I was in bed for the next 12 days and everyday I was developing various symptoms. By day 4 I had no taste and impaired smell and day 5-12 I had body aches, congestion and a cough that would not go away. I was our of work from 01/12/21-01/25/21.
45 2021-03-22 feeling of body temperature change, tremor 5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, he... Read more
5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, heart raced, shaking and sweating, hands trembled, light headed, felt both hot and cold at same time. Patient alerted pharmacist and sat down in chair. 23 minutes after vaccine patient not 100% but better, feel fuzzy in head, shaky and feel sweaty but not sweating, carpet looks weird (patient states has hallucinations from other drugs). 25 minutes after vaccine patient light headed, vision not perfect. 28 minutes after vaccine patient's body feels warmer 32 minutes after vaccine patient feels unbalanced, body warm, legs heavy. 36 minutes after vaccine patient's feet feel heavy, feel more normal, temperature difference, sweating stopped, feel more like herself. 39 minutes after vaccine patient's feet feel smidge heavy, feel like herself. 41 minutes after vaccine patient left observation.
45 2021-03-22 migraine Migraine tiredness muscle pain. Chills fever
45 2021-03-22 tremor, speech disorder Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy ... Read more
Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy rash to chest, abdomen, back and bilateral arms. I was wheelchaired over to the Urgent care section of the building with a Dr following along. By the time I reached the Urgent Care room I was feeling the same strange feeling in my mouth tongue and throat that I had felt with the first vaccine. I felt as if my tongue and possibly lips may be swelling a little though I don?t think they were. It was hard to swallow but I have a mitochondrial disorder which causes trouble swallowing at times too so it may have been a little worse than what I usually feel with that. I seemed to be having trouble pronouncing words as my tongue seemed to be in the way and my voice weaker. By blood pressure was elevated as it was after the first vaccine. I was given a subcutaneous shot of epinephrine and the symptoms started to improve within approximately 15-20 minutes though I was very shaky and anxious from the epi. I was then given an IM injection of Benadryl. After possibly an hour and a half I was sent home with my husband an epi pen and a script for prednisone. I continued to have a strange feeling in my mouth and throat on and off for a couple of days but less severe and I did not use the epi pen for
45 2021-03-23 weakness I woke up with severe chills from 4am-10am and then had fever of 103 plus that afternoon, could bare... Read more
I woke up with severe chills from 4am-10am and then had fever of 103 plus that afternoon, could barely get up out of bed, nausea, weakness, dizziness. Aches all over my body and joints especially, intense headache, pain at injection site. The next night, same thing, woke up at 5am with chills and fever of 103 plus and all the other symptoms the second day. I was in so much pain I considered going to the doctor but could barely move. Tylenol did not touch it. I was delirious. The third night/day the fever finally had broken but I was still super weak and tired. The next day I was better. Anyway, if I had the option I would not take the vaccine again because of these side effects.
45 2021-03-23 breast pain About 30 minutes after the shot I got really tired. 30 - 45 minutes later I got really happy and sta... Read more
About 30 minutes after the shot I got really tired. 30 - 45 minutes later I got really happy and started to laugh a lot. It got worse with movement and was containable if I was sitting still. I was unsteady on my feet as well. I kept losing my balance. I would describe it as euphoria or intoxicated. Lasted until about 10:30 pm when I got really tired and fell asleep pretty quickly. This morning I am just tired and sore with a headache.
45 2021-03-23 difficulty speaking 15 min. after administration, pt became short of breath and hoarse. Hospital Rapid Response called,... Read more
15 min. after administration, pt became short of breath and hoarse. Hospital Rapid Response called, pt took Benadryl 50mg PO and then transported immediately to the ED for further evaluation. ED administered Solumedrol and epinephrine.
45 2021-03-23 difficulty speaking Patient received dose 1 of Pfizer vaccine - developed hoarse voice and increased SOB
45 2021-03-23 migraine, flushing Redness/Flush Face within minutes, Minor itching Migraine headache within hours including Jaw pain M... Read more
Redness/Flush Face within minutes, Minor itching Migraine headache within hours including Jaw pain Muscle tightness in neck and shoulders Soreness at injection site
45 2021-03-24 weakness Guest patient, reported feeling dizzy, complained of being very weak after receiving her first dose ... Read more
Guest patient, reported feeling dizzy, complained of being very weak after receiving her first dose of Pfizer Vaccine - (Lot #ER8712), administered in the LD at 14:37 hours. Guest complained of feeling ? ?the loss of strength?, to the upper part of her body and that she ?just wanted to close her eyes and sleep.? EMS activated to the Observation Area. Vital Signs assessed: B/P-110/60, P-74 (reg), R-18, T-98.5, 100%, and blood glucose reading of 94. EMS completed further evaluation and guest was released at 14:53 hours reporting that she was no longer experiencing the above complaints/or symptoms. She was offered and accepted water and more observation time. Client reported ?I am back to normal.? Client observed sitting talking on a cellphone and appears to be no apparent distress.
45 2021-03-24 weakness Pt received 1st COVID vaccine on 2/23/21. Returned to clinic on 3/17/21 for 2nd dsoe. Reports "being... Read more
Pt received 1st COVID vaccine on 2/23/21. Returned to clinic on 3/17/21 for 2nd dsoe. Reports "being itchy without any rash on various parts of the body" about a week after injection. Also reported no appetite and a dry mouth along with being weak and tired. Denied any dyspnea, rash, or other s/s allergic reaction or anaphylaxis. States s/s resolved after 1-1.5 weeks. Did not seek medical care. States "she thinks it may have been pre- or post- menstrual issues and/or supplements". Also states she had had rash in December 2020 of unknown cause. Reports she used "allergy cream then and was sick to her stomach" and was resolved before first dose.
45 2021-03-24 difficulty speaking I started with a cough and that got progressively worse until I started throwing up. After throwing ... Read more
I started with a cough and that got progressively worse until I started throwing up. After throwing up I felt like I could not get enough air for about 40 mins. I had a Abuteral inhaler left from fighting bronchitis so I took a few puffs of that and started to feel a little better. Through the night I continued to throw up a few times and having a lot of coughing. The next day mt throat was on fire and could not really talk. I am assuming this was from all the coughing and throwing up.
45 2021-03-24 facial pain Fevers for several days, nausea, diarrhea, myalgias/arthralgias., headaches, sweating, worsening R s... Read more
Fevers for several days, nausea, diarrhea, myalgias/arthralgias., headaches, sweating, worsening R sided facial pain; these have been persistent for 1 week now
45 2021-03-24 feeling hot Patient stated her face was feeling itching and was hot. Patients face was red and warm to touch. Pa... Read more
Patient stated her face was feeling itching and was hot. Patients face was red and warm to touch. Patient was given 10mg of oral cetirizine. Patient observed for 30 minutes in observation area. Patient went home with spouse, stated she was feeling better. Redness in face resolved.
45 2021-03-24 pain in extremity, weakness 1. Felt arm soreness after shot and tried to move around around a lot and flex muscle to reduce sor... Read more
1. Felt arm soreness after shot and tried to move around around a lot and flex muscle to reduce soreness. 2. Started feeling chills, muscle aches, headache and nausea around 9:00PM. 3. Began vomiting around 11:00PM, with other symptoms remaining. Vomited about 3 separate times that evening. 4. The following day, felt chills, muscle ache, joint ache, skin pain, nausea, headache and arm pain, along with sore throat (probably caused by previous night's vomiting). I had very low energy and did not want to eat or drink anything. I began taking Tylenol every 6-8 hours and taking Pepto Bismol as needed to address the nausea. 5. The symptoms continued, but lessened each day over the course of the next 5 days. I anticipate symptoms will continue to reduce over the next 1-2 days, and no treatment will be needed.
45 2021-03-24 pain in extremity Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine... Read more
Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Fever; Body aches; She felt like she was going to die; feels awful; Constipation; Couldn't keep her eyes open; Chills; Sore arm; Tired; couldn't keep her eyes open; Nauseousness; Lightheaded; it felt like someone was playing with my head and controlling her memories; sugar levels going up; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6205 and expiration date 30Jun2021 received on 03Mar2021 as a single dose (at the age of 45 years), unspecified route in left arm for COVID-19 immunisation. History included thyroid removed in 2014 and diabetes in 2019 (diagnosed about a year and a half ago), Cirrhosis liver, fatty liver. Concomitant medications include metformin for diabetes, glyburide for diabetes, levothyroxine sodium (TIROSINT) for thyroid disorder, cetirizine hydrochloride (ZYRTEC), omeprazole, ascorbic acid (VITAMIN C), zinc, ergocalciferol (VITAMIN D), bifidobacterium lactis (PROBIOTIC), fluticasone propionate (FLONASE), albuterol (SALBUTAMOL), and budesonide, formoterol fumarate (SYMBICORT). Following the vaccination on 03Mar2021, she came home at night with sore arm and started getting chills. She felt very nauseous. She could not open her eyes anymore. She went to sleep and woke up in the middle of the night. She felt like someone was controlling her memories. It felt like someone is taking away memories (Mar2021) and she was trying to hold on. Like something was messed up in her head. The next day she woke up with a sore arm and felt fine. She had a little nauseousness but it was controlled. On Friday (04Mar2021), the vaccine site became red, hot, hard, and had a white ring around it. The more red it became the more fever, nauseousness, and constipation she had. She couldn't keep her eyes open. She started coughing. She had to use her inhalers even more. Her inhalers are Albuterol and Symbicort and she doesn't have a lot number to provide for her inhalers. All day she felt that way. She felt like she was going to die, has body aches. It was awful. She also had dizziness at nighttime she took the ice pack and froze her arm because she couldn't take it anymore. Saturday, 05Mar2021 she woke and still had dizziness and couldn't go to the bathroom. She feels nauseous. She can't keep her eyes open. Sunday (06Mar2021) it was better (unspecified events), but she is not herself. Ever since then she feels like she is always tired. Today it has been a week after and she is so tired. She called the number and one of the representatives said she wouldn't do the second dose. The doctor said it is side effect. She also reported that she is lightheaded. She said her sugar numbers have been sky high. She told the nurse that it didn't hurt like the flu shot. She did not have NDC, lot, and expiry to provide for flu shot. Lab information in Mar2021 included Sugar levels were up and weight: 203 to 205 pounds. Outcome of events was unknown.
45 2021-03-24 pain in extremity 10 days after my first dose of Pfizer, I still have pain in the injection arm. It has been almost a... Read more
10 days after my first dose of Pfizer, I still have pain in the injection arm. It has been almost a month since I have gotten the 1st shot.
45 2021-03-24 pain in extremity Soreness in arm; Rash covering neck, chin, scalp, ears, arm (non-shot arm)
45 2021-03-24 tingling, numbness tingling, slight numbness in pinky and left side of ring finger
45 2021-03-24 tingling Face tingling, lightheadedness. History of childhood anaphylaxis with nuts, carries epi pen and bena... Read more
Face tingling, lightheadedness. History of childhood anaphylaxis with nuts, carries epi pen and benadryl. Sx onset within 15 minutes of first dose of pfizer vaccine administration. Tx: recline in car seat, lower extremety elevation. Pt given 25mg PO diphenhydramine upon pt request. Approximately ten minutes later pt states facial tingling and lightheadedness subsiding. Pt then had son (vaccinated at same time) drive them home.
45 2021-03-24 tremor At first my eyes , mouth, and throat started to burn, then I started to shake uncontrollably for sev... Read more
At first my eyes , mouth, and throat started to burn, then I started to shake uncontrollably for several hours. I went straight to the ER when it started. Every day since then I have had several shaking episodes lasting in length from 30min to 2 hours. After I get a horrible headache and feel exhausted.
45 2021-03-25 weakness, pain in extremity congestion; Fever; headache; weakness; arm pain; armpit pain; This is a spontaneous report from a co... Read more
congestion; Fever; headache; weakness; arm pain; armpit pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN5918) via an unspecified route of administration in the Left arm (at the age of 45-year-old) On 18Feb2021 at 10:45 as a single dose for COVID-19 immunisation. The patient medical history included Hypoglycaemia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included buspirone hydrochloride (BUSPAR), (sertraline hydrochloride) ZOLOFT, simvastatin (ZOCOR), amitriptyline, clonazepam (KLONOPIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Flonase and experienced allergies and also took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 28Jan2021 at 13:45 in the left arm (at the age of 45-year-old) for COVID-19 immunisation. On 18Feb2021, at 17:00 the patient experienced Fever, headache, weakness, congestion, arm pain, armpit pain. The patient did not receive any treatment for the events. The outcome of the events was not recovered. Information about Lot/batch has been requested.
45 2021-03-25 weakness Dizziness, weakness, reduced appetite and fatigue
45 2021-03-25 flushing Nurse notified at approximately 2:30 Client taken to private recovery area RN also present in priva... Read more
Nurse notified at approximately 2:30 Client taken to private recovery area RN also present in private recovery area Client initially stated that it felt like she had swelling in her jaw area and neck Client reports no difficulty breathing At 2:35 After further questions the client states that a better word would be tightness. No swelling noted Client reports left sided jaw tightness and tightness and stiffness in the neck (just below her left ear) Vitals taken : BP 138/99, Pulse 106, O Sat 98 Client states that it feels like when she has TMJ Client reports feeling a flushed sensation go up her arm towards her jaw and neck after the injection At 2:40 Client reports that the pain/ tightness in her jaw has lessened and no longer feels like its building Client was previously given water Client reports no difficulty breathing and No sensation of her throat closing At 2:42 Client states that when she has issues with TMJ she normally takes Benadryl which helps One 25mg tablet of Benadryl was given with a sip of water Client is not driving and came with her husband. Her husband will drive Client reports feeling like its calming down I let her know that she didn?t have to leave immediately and could still sit At 2:49 Client reports feeling better than when she arrived in the private recovery area Vitals taken: BP 134/105, Pulse 105, O Sat 99 A few minutes later her husband arrived At 2:57 Client reports feeling well enough to leave Client was driven today by her husband Client was advised to seek further care via call 911 if symptoms worsen or difficulty breathing Client able to ambulate to the car unassisted
45 2021-03-25 numbness, pain in extremity 3/26/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ... Read more
3/26/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: Numbness to left fingers,left arm aches, . Assessment : Time of assessment 1040am Alert and oriented. No redness or swelling, able to move fingers, reports pain 3?10. Actions taken: VS @1040am BP- 149/100, P- 81, O2- 99%, recheck at 1049 BP- 152/87, recheck @ 1131- 147/79, P- 77, O2-100%. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/26/2021 10:46 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc
45 2021-03-25 pain in extremity Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours la... Read more
Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours later developed a bright red. burning and painful rash on my face. On day 3 I went to work and underneath my right eye started to swell up and a red streak from the inner corner of my eyelid went down my face. On day 4 I woke up with both eyes swollen. I started on benedryl. 2x a day. The redness, welts and hives traveled down my face, onto my neck, then up my forehead and onto my earlobes. On March 22, day 5, I woke with even more swelling on my face and both eyes. The rash was very bad. I called my primary care physician and made an appointment to see him on Tuesday. I went for that appointment and dr. gave me antihistamines, took pictures and reported it to CDC. I started the antihistamines, but on Day 7, I woke up with the worst of it. Hives all down my neck, lips swollen, bruising and swollen eyes and itchy red rash everywhere. I called the dr back and started prednizone steriods. Today, March 26, it is starting to calm down.
45 2021-03-26 migraine fever, severe chills, tachycardia, diaphoresis, nausea, migraine
45 2021-03-26 pain in extremity, tingling Whole body inflammation, tingling and pain from neck to fingers down right arm. Also, hives from rig... Read more
Whole body inflammation, tingling and pain from neck to fingers down right arm. Also, hives from right forearm to elbow.
45 2021-03-26 tingling, pain in extremity Severe , aching pain in arm, underarm, back. Tingling in fingers. Tired, sluggish
45 2021-03-28 weakness 20 minutes after the vaccine I felt very faint and weak. My blood pressure went up. My throat starte... Read more
20 minutes after the vaccine I felt very faint and weak. My blood pressure went up. My throat started to swell. This is a typical mast cell reaction for me. I took 20 mg of Fomatadine a few minutes later. I had already had 50mg Bendryl on board. About 20 minutes after the Fomatadine the swelling in the throat started to improve slightly. I left the facility where I had the shot after about an hour and my condition did not worsen. I fulle recovered in about 48 hours.
45 2021-03-28 numbness, burning sensation, tingling, feeling hot On approximately 1/4/21, 1 week after 1st vaccine dose, developed headache & a head cold. Went to EN... Read more
On approximately 1/4/21, 1 week after 1st vaccine dose, developed headache & a head cold. Went to ENT on 1/11, diagnosed with acute on chronic sinusitis, prescribed Augmentin & Prednisone to start 48 hours after 2nd vaccine dose. Sinusitis did not explain headache as I've never presented with headache in the past. 2nd vaccine dose 1/14/21; began Augmentin & Prednisone on 1/16 (wanted to hold off on treatment until after 2nd vaccine dose). Headache continued & began to worsen. I thought maybe due to prednisone or high blood pressure from prednisone? Visit to PCP on 1/25 due persistent headache that was not resolving (Headache was vice-like, pain moderate to severe, headache worse with exertion or bending over). 1/25 "worst headache of my life". MRI ordered & completed 1/27; MRI normal other than sinusitis. Visit to ENT on 1/28; she said sinusitis improving & prescribed Norco for headache pain. Visit to PCP on 1/30; he prescribed Gabapentin & Naproxen for headache pain. Visit to Naturopath on 2/4; recommended adding Magnesium & B Vitamin Complex. 2/5: Massage with worsening headache pain. 2/10: Chiropractor & Acupuncturist with worsening headache pain. 2/19: Visit to Urgent Care for Toradol shot & Cyclobenzaprine prescribed. 2/23: Visit with Neurology; prescribed Topamax & Prednisone. 3/5: felt strange sensations in body, wave like feeling over limbs, tension in skull, heart pounding, change of hearing, menthol sensation on skin, change of taste, worsening headache, warm feeling in chest & abdomen, lasts 1-2 minutes. 3/6: ED visit due to strange episode/sensations; Neurologist on call prescribed Fioricet & Nortriptyline. 3/9: visit to Neurology, she increased metoprolol to 50mg, injected Ajovy, prescribed more cyclobenzaprine & ordered MRI/MRV. Headache pain continued to be moderate to severe, constant & "nervy", episodes continued to occur daily. 3/12: bloodwork to check inflammation. 3/14: MRI/MRV completed. Headache worsened with MRI noise & injection of contrast. 3/16: lumbar puncture completed w/ normal pressure, awaiting CSF labs. Discontinued Topamax 3/21; thought maybe contributing to episodes. More bloodwork completed 3/24. Visit to PCP, given Nurtec sample with some relief. Otherwise, headache remains daily & persistent with little/no relief overall. Head pain is bilateral, vice-like, burning sensation @ times on skull or face, numbness & tingling both sides of face periodically. Headache worsens with activity & at night. Episodes (strange sensations) continue to occur 1-3x/day, usually when laying down, at night or in morning.
45 2021-03-28 migraine Migraine headache for 2 days
45 2021-03-28 muscle spasms Immediate reaction: dizziness and muscle cramps, especially in left side and a lot in my left foot..... Read more
Immediate reaction: dizziness and muscle cramps, especially in left side and a lot in my left foot...whole foot cramped up immediately...dizziness and cramping went away in about 40 minutes. Since then, I have been having extreme rushes of adrenaline for almost a week now...lasting almost all day. I will wake up feeling ok, but as the day progresses, the adrenaline starts up. It has been unbearable. I've had heart palpitations, fluttering, jumping, etc because of it. It feels as if I am on prednisone (I was on 60mg 8 years ago and it really messed with my adrenal glands). I am unsure if I can take the second dose because of the side effects I had from the first. I know thousands of people and I know no one
45 2021-03-28 pain in extremity, weakness, feeling of body temperature change Sore arm, chills, body aches, hot and cold spells, and weakness.
45 2021-03-28 pain in extremity Very sore arm lasting about 24 hours
45 2021-03-28 tingling, burning sensation Immediate red face and neck and chest. Itchy all over. Developed into burning pins and needles fee... Read more
Immediate red face and neck and chest. Itchy all over. Developed into burning pins and needles feeling. Took 50 mg Benadryl. 12 hours later I went to ER for intense pins and needle feeling in my face and arm. Inching on legs too. Given Pepcid and a steroid shot. Following day I took Claritin because symptoms were still bad.
45 2021-03-29 weakness, cold extremities, feeling cold Day1- Cold sensation, felt tight throat when trying to swallow liquids; day 2- went to er at Regiona... Read more
Day1- Cold sensation, felt tight throat when trying to swallow liquids; day 2- went to er at Regional Medical Center for chest pain, sob; went to PCP, reports that she has been having cold arms and leg (raynaud's like presentation) went to Hospital er twice, now is in Regional Medical Center er with chest pain, headache, generalized weakness, reports that the cold sensations continue, patient was started on hctz after the vaccine for high BP, then amlodipine, patient was then taken off amlodipine and hctz and started on bystolic; tight senstions in the throat continue along with cold sensations; intermittent chest pains, headache
45 2021-03-29 pain in extremity (3 days after): Pain in hand/wrist, body aches, nausea (2 days after): Fever, Pain at the injectio... Read more
(3 days after): Pain in hand/wrist, body aches, nausea (2 days after): Fever, Pain at the injection site (that radiates into hand and wrist), nausea, body aches, chills, extreme exhaustion. (1 day after): Stinging sensation of left ear and scalp, headache, lethargy, exhaustion. (Day of Vaccine): spaced-out feeling (like everything was in slow motion).
45 2021-03-29 pain in extremity In the evening - I had a mild headache and chills; And had generalized joint pain and soreness on th... Read more
In the evening - I had a mild headache and chills; And had generalized joint pain and soreness on the arm on Saturday and Sunday. Those all continued for a few days and then that resolved. Shortness of breath and chest pain started 10 days after - they lasted for about a week and they resolved simultaneously. I went to my doctor and he did some tests. Everything was normal. No treatment except diet and exercise.
45 2021-03-30 weakness I have experienced Headache; chills; felt weak the first day; This is a spontaneous report received ... Read more
I have experienced Headache; chills; felt weak the first day; This is a spontaneous report received from a contactable other health Care Professional (patient herself). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via unspecified route of administration, in right arm on 03Feb2021 16:00 at single dose for COVID-19 immunization. Medical history included Allergies: Penicillin and Allergies: Sulfa. The patient concomitant medications were not reported. Patient previously took first dose BNT162B2 on 13Jan2021 16:00 for COVID-19 immunization. On 04Feb2021 06:00, the patient experienced chills, first day felt weak, the second day felt better and Third- and fourth-days experienced headache. Treatment received was reported as no. The event considered non serious. The outcome of the events was recovering. Batch/lot number has been requested.
45 2021-03-30 weakness From 10PM (approx 9 hrs post 2nd injection), symptoms included fever and severe chills and joint pai... Read more
From 10PM (approx 9 hrs post 2nd injection), symptoms included fever and severe chills and joint pain; slight dizziness; vomit x1 at 6AM the next morning; symptoms subsided by approx 24 hrs post injection. Minor weakness and overall malaise continued for approx 48 hrs total.
45 2021-03-30 numbness, burning sensation Numbness in left arm and face. Burning/raw feeling in (on) left arm. Initial reaction to shot was f... Read more
Numbness in left arm and face. Burning/raw feeling in (on) left arm. Initial reaction to shot was fine. I waited 15 minutes and had a "weird" feeling in my left arm and ring and pinky fingers. Once I started walking to my car I noticed that my cheeks were feeling different. My tongue felt larger than normal as I was driving home. For most of the day my left side from roughly my armpit down my arm and the left side of my face felt different. Not quite numb, but not normal. Spent most of the day resting in bed. The raw/burning feeling lasted until Sunday (shot was on Saturday). The injection site looks great. No swelling or itching.
45 2021-03-30 pain in extremity, muscle spasms Severe muscle spasm in back, left side (center) 13 hours after injection in upper left arm. Soreness... Read more
Severe muscle spasm in back, left side (center) 13 hours after injection in upper left arm. Soreness in left arm.
45 2021-03-30 pain in extremity lymphatic nodes were swollen; right knee swollen; cannot walk yet; Leg pain; other specified soft ti... Read more
lymphatic nodes were swollen; right knee swollen; cannot walk yet; Leg pain; other specified soft tissue disorders.; leg bumps/or swelling; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:30 (Batch/Lot number was not reported), at the age of 45-year-old at vaccination, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. There were no concomitant medications. The patient previously took NSAIDS and experienced drug hypersensitivity. The patient did not have COVID prior vaccination. On 09Mar2021 06:00, the patient woke up with her right knee swollen and had difficulty walking. She went to the Hospital in the afternoon and was told that her lymphatic nodes were swollen, and the diagnosis is Leg pain and swelling and other specified soft tissue disorders. The still have a swollen knee and cannot walk yet, 6 days after the vaccine. The patient still have leg bumps/or swelling in her leg. The patient was hospitalized for lymphatic nodes were swollen. It was also reported that patient has physician and ER visit. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events which includes Codeine/paracetamol, RICE routine care for injury. Information about Batch/Lot number has been requested.
45 2021-03-30 pain in extremity It started with my hands aching and then I had a lot of body aches. By noon, I had a terrible headac... Read more
It started with my hands aching and then I had a lot of body aches. By noon, I had a terrible headache and was running a fever. Later, the lymph node under my arm on the side of the injection was swollen and a little painful.
45 2021-03-31 slurring within 5 min pain in ears 30 min neck and jaw pain 45 min ringing in ears next day - joint and muscl... Read more
within 5 min pain in ears 30 min neck and jaw pain 45 min ringing in ears next day - joint and muscle pain, headache, fatigue day two slurring speech, nose burning day 4- ears ringing and fatigue, dizzy
45 2021-03-31 feeling hot Starting in the late evening of the first day and extending to the second-day chills, fatigue, and ... Read more
Starting in the late evening of the first day and extending to the second-day chills, fatigue, and fever. Today, the fourth day, my face is hot to the touch and skin is blotchy with eyes burning.
45 2021-03-31 numbness, tingling Client stated they were experiencing some tightness in the throat with some numbness and tingling; n... Read more
Client stated they were experiencing some tightness in the throat with some numbness and tingling; no difficulty breathing. Ambulance was called and Client was transported to nearest facility
45 2021-03-31 pain in extremity First day and first night extreme Sore arm- no sleep Second day - fatigue, foggy head, nausea , mo... Read more
First day and first night extreme Sore arm- no sleep Second day - fatigue, foggy head, nausea , moodiness, extreme finger joint pain Third day (today) - Headache , ears ringing, low fever, joint pain, sensitive skin, exhaustion,
45 2021-04-01 weakness, pain in extremity Initially just a sore arm and then I was very fatigued that evening. The next morning I had a fever... Read more
Initially just a sore arm and then I was very fatigued that evening. The next morning I had a fever, muscle aches, a headache and intense nausea. I alternated Tylenol and Ibuprofen every 4 hours the remainder of the day. The next day I felt much better but still felt weak/fatigued.
45 2021-04-01 involuntary muscle movements, tingling it was worse; I had to take Benadryl to sleep; eye lid tingling; Also reports pain on the top of her... Read more
it was worse; I had to take Benadryl to sleep; eye lid tingling; Also reports pain on the top of her head and last night aching on left side of her head; Eyelids with poking sensation; lip is jerking, jerking of eyes; pain on left side of her neck; I feel my gland is swollen with a lump on left side; I have had tingling and a needle pain sensation all over my body./Tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head; Has to work through the pain/Pain ran down along left side of neck a couple of nights ago also;; Left top of head aching sensation; It is effecting her work and daily life.; This is a spontaneous report from a contactable pharmacist. A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205, Expiration date: not reported via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 14:25 (at the age of 45-years-old) as single dose for COVID-19 immunization. Medical history included ongoing hepatitis B, Kidney stone from 2019 and ongoing. Concomitant medication(s) included tenofovir disoproxil fumarate (Dosage text : 300mg Tablet once daily at night) taken for hepatitis b. The patient's father has high blood pressure and heart problems and mother is fine as stated. The patient experienced tingling and a needle pain sensation all over my body/tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head on 07Mar2021, had to take benadryl to sleep on an unspecified date with, eye lid tingling on an, on 16Mar2021 lip is jerking, pain on left side of her neck, feel the gland is swollen with a lump on left side, also reports pain on the top of her head and last night aching on left side of her head, eyelids with poking sensation, jerking of eyes, left top of head aching sensation, it is effecting her work and daily life, has to work through the pain/pain ran down along left side of neck a couple of nights ago. Therapeutic measures were taken as a result of insomnia. The outcome of event Tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head, Lips Jerk, Jerking of Eyes, Left side of neck lump like a swollen lymph is Not Recovered, Left top of head aching sensation, Pain ran along left side of neck is Recovered. Follow up (17Mar2021): New information included clinical information and description of product complaint: Is there a Product Complaint: Taking benadryl last two nights to sleep, did not help last night. Product strength and count size dispensed: 25mg. Additional lot numbers: P117225. Is a sample of the product available to be returned, if requested: No No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering a plausible temporal association, a causal relation between the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
45 2021-04-01 numbness Patient complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient ... Read more
Patient complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient stated she has high BP and a history of stroke. BP was158/114. 911 was called and ambulance arrived in 10 -15min. EMT assessed patient and asked her to smile. Patient's left face was not responding normally, Patient asked to lift both arms. Patient could not fully lift both arms. Patient transported to hospital.
45 2021-04-02 tingling, flushing 3:50pm tongue and lips were feeling swollen, numb, and tingling, body as a whole felt odd (like she ... Read more
3:50pm tongue and lips were feeling swollen, numb, and tingling, body as a whole felt odd (like she could faint), 3:52pm gave her 25mg oral liquid benadryl, 3:54pm b/p was 129/84 and pulse was 74, 3:56pm symptoms dramatically improved, but were not gone, 4:05pm slight numbness and tingling of lips and tongue, 4:22pm blushing of face and tingling of tips of fingers, 4:23pm gave another 25mg oral liquid benadryl, 4:32 gingling improved , but not gone, 4:34pm b/p 132/77 pulse 68, 4:38pm blushing almost gone, 4:39pm tingling in finger tips gone, 4:53pm no change-still slight numbness and tingling of lips and tongue, 4:55pm parents arrived and followed my recommendations and took her to the emergency room, she was treated (unknown), then released with prescriptions for benadryl 25mg and a medrol dose pak.
45 2021-04-03 hot flush Severe chills and hot flashes, difficulty breathing, chest pain, nausea, headache, rapid heartbeat. ... Read more
Severe chills and hot flashes, difficulty breathing, chest pain, nausea, headache, rapid heartbeat. Swollen lymph nodes in armpits and under jaw. Bed rest, sleep, daytime/nighttime cold medicine, liquids.
45 2021-04-04 weakness Headache, fever over 100 degrees. Weakness, loss of appetite for almost 2 weeks now.
45 2021-04-04 cold sweat Headache, could not move arm due to pain, nausea, low temp, cold sweat, rash on face and neck, tired... Read more
Headache, could not move arm due to pain, nausea, low temp, cold sweat, rash on face and neck, tiredness and muscle pain
45 2021-04-04 hot flush Itchy tongue and throat. Hot flashes. Raised heart rate and blood pressure
45 2021-04-04 migraine Nausea within hours of 2nd shot. Next day extreme body aches/ joint pain, nausea. Day 2 and 3 tire... Read more
Nausea within hours of 2nd shot. Next day extreme body aches/ joint pain, nausea. Day 2 and 3 tired. Day 4: extreme headache/migraine, nausea, vomiting, diarrhea, exhaustion. Day 5: extreme headache, nausea, exhaustion. Day 6-11: headache and exhaustion.
45 2021-04-04 pain in extremity, burning sensation Between 5-10 mins after receiving dose, patient started having R sided chest pain and difficulty bre... Read more
Between 5-10 mins after receiving dose, patient started having R sided chest pain and difficulty breathing. patient was transported the EC. Blood test, urine test, CT chest w/o contrast. Was told pulled a muscle while sitting and doing nothing (@ holding area). Correlation can't be made with any degree of certainty if related to vaccine. Felt burning sensation in arm after receiving vaccine and then pain on right side right under armpit (stabbing sensation). Every time took a breath in, felt pain. Patient reported having a hard time walking. Wasn't given any medication in EC. Pain was manageable after 5 hours.
45 2021-04-04 pain in extremity 4/1/21 - sore arm, slight fatigue 4/2/21 - muscle aches all over, fatigue - treated with OTC ibuprof... Read more
4/1/21 - sore arm, slight fatigue 4/2/21 - muscle aches all over, fatigue - treated with OTC ibuprofen 4/3/21 - slight muscle aches, low-grade fever (99.9 F) - treated with OTC ibuprofen 4/4/21 - moderate presentation of rash/hives on lower inner arms, area between shoulders and chest, and base of spine - treated with OTC benadryl, one dose in morning and one in evening
45 2021-04-05 discomfort Patient had facial swelling, lip swelling, and tongue heaviness two days after recieving the second ... Read more
Patient had facial swelling, lip swelling, and tongue heaviness two days after recieving the second dose of vaccine. She took Benadryl 25 mg every six hours and this resolved in three days.
45 2021-04-05 pain in extremity Arm pain, chills, muscle aches, joint pain, head ache, low fever
45 2021-04-05 pain in extremity I started experiencing swelling and pain in my ankle and right leg.
45 2021-04-05 tingling, numbness Tingling and numbness in left arm.
45 2021-04-05 tenderness, pain in extremity Drowsiness, pain in arm and up shoulder. Chills and fatigue 10-13 hours after shot. Felt better 24 h... Read more
Drowsiness, pain in arm and up shoulder. Chills and fatigue 10-13 hours after shot. Felt better 24 hours after shot except for arm tenderness, which lasted an additional 24 hours.
45 2021-04-05 tremor, weakness severe weakness, low blood pressure, tachycardia, feels faint/near syncope, mild but new dyspnea on ... Read more
severe weakness, low blood pressure, tachycardia, feels faint/near syncope, mild but new dyspnea on exertion and severe tremor of hands interfering with activities such as feeding herself, occasional mild headache. admitted to observation in emergency center, discharged home
45 2021-04-06 weakness The morning after, felt weak, tired, chills, lasted into Sunday. Constant diarrhea ever since the 2... Read more
The morning after, felt weak, tired, chills, lasted into Sunday. Constant diarrhea ever since the 2nd vaccine, not hungry in the morning
45 2021-04-06 numbness, pain in extremity, migraine, tenderness Initial reaction: night of April 1-2: moderate leg aches, restlessness, hip joint pain, feeling fev... Read more
Initial reaction: night of April 1-2: moderate leg aches, restlessness, hip joint pain, feeling feverish w/out fever, mild chills April 2-3: moderate to severe fatigue, lethargy symptoms eased on evening of April 3 Secondary reaction: April 4, evening through today, April 7: lymph nodes in left armpit, left side of neck, left jaw sore and tender, possibly slightly swollen. Back left jaw felt slightly numb on first day. Left side of neck feels as if muscles sprained. No fever. Brief, mild tenderness at injection site on right arm.
45 2021-04-06 pain in extremity severe L arm pain limiting ability to raise arm followed by slow recovery 2 weeks out but then a day... Read more
severe L arm pain limiting ability to raise arm followed by slow recovery 2 weeks out but then a day of severe fatigue, feeling unwell and resurgence/worsening of the L arm pain - exam is consistent with a deltoid tendonitis (supraspinatus seems rather intact) and she also has a mass/nodule mid arm inferior to the vaccine site
45 2021-04-06 tingling Was given the shot on Friday, April 2, 2021 at 4:33pm within 20mins I got mild tingling in my tongue... Read more
Was given the shot on Friday, April 2, 2021 at 4:33pm within 20mins I got mild tingling in my tongue on the left side and slight tingling in my cheek on the left side of my face--like when Novacane is wearing off. I didn't say anything since I thought it was more anxiety then the shot. It was very mild and lasted 4 hours then it moved to like a mild tooth ache by 8:45pm. The mild tooth ace would come and go for the next 3 days (April 5th last day). Woke on April 6th to a swollen top lip which went away by 12pm. No symptoms on April 7th. I didn't report this since I thought it was anxiety but I did call the next day the hospital hotline to advise about tingling then called primary care doctor on April 6th when my lip swelled.
45 2021-04-06 tingling Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Left arm tingling 10... Read more
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Left arm tingling 10 min post immunization. Patient recovered\r\n
45 2021-04-06 tremor C/o anxiety, shaking of head, did not eat breakfast. B/P 122/71, HR 82, O2Sat 98, T 98.
45 2021-04-07 numbness, tingling I received the vaccine on April 6. At the time of receiving the vaccine I began to feel numbness in ... Read more
I received the vaccine on April 6. At the time of receiving the vaccine I began to feel numbness in the tip of the tongue, lips and central incisors, on April 7, the day after receiving the vaccine I began to feel numbness in the small fingers of both hands. Today, April 8, the numbness of the lips and the numbness and tingling still persist in all the fingers of the hands, especially the little fingers
45 2021-04-07 pain in extremity, migraine I exp GI symptoms and migraine. I exp burning, nausea (GI symptoms) lasting 3 days. It felt like aci... Read more
I exp GI symptoms and migraine. I exp burning, nausea (GI symptoms) lasting 3 days. It felt like acid reflux took medication seems as if someone poured acid down my throat. My arm pain was minimal, no fever and extreme fatigue (not a coffee drinker I was so tired wanted some caffeine).
45 2021-04-07 pain in extremity Pain in hands and shoulders,or knees with her knees "locking up"; Pain in hands and shoulders,or kne... Read more
Pain in hands and shoulders,or knees with her knees "locking up"; Pain in hands and shoulders,or knees with her knees "locking up"; Pain in hands and shoulders,or knees with her knees "locking up"; sick; Extreme Fatigue; This is a spontaneous report from a contactable Nurse. A 45-year-old female patient received BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Dec2020 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. It was unknown whether patient was pregnant at time of event or not. Medical history included rheumatoid arthritis. The patient received 1st covid vaccine on 26Dec2020 and diagnosed with covid19 on 05Jan2021. Patient reported while sick "no significance changes with rheumatoid arthritis symptoms just extreme fatigue". 2nd covid vaccine was received on 20Jan2021. Patient reported "no significant side effects with vaccine". Patient also reported that in the last 6 months when there was any significant change in the weather she experienced pain in hands or shoulders or knees with her Knees "locking up". Patient also received tofacitinib citrate (XELJANZ XR, strength: 11 mg, Manufacturer: Pfizer labs) tablet (30's) orally from 25May2020 at 11 mg daily for rheumatoid arthritis and hydroxychloroquine sulfate (PLAQUENIL) started from 29Aug2020. The outcome of events was unknown. Lot/Batch number has been requested.
45 2021-04-07 pain in extremity Headache, soreness in arm, stomachache that lasted 3 days
45 2021-04-08 cold sweat Severe Nausea Vomiting 2 hrs after. Forceful vomiting from car door no time to get anywhere. Chills... Read more
Severe Nausea Vomiting 2 hrs after. Forceful vomiting from car door no time to get anywhere. Chills Vulvar pressure- this is strange and I almost don?t mention it except for it came on suddenly same time as vomiting and was severe ! Site soreness up thru neck Cold sweats Loss of apetite Tired Immediately 3-4 hrs after severe fatigue and drowsiness Slowed pulse Foggy brained Hot skin Red skin allover
45 2021-04-08 feeling hot Two days after the vaccine my arm became really hot and swollen. It was a circle about the size of a... Read more
Two days after the vaccine my arm became really hot and swollen. It was a circle about the size of a baseball on my left arm around the site of injection. It looked like cellulitis. I also had a lump under my arm. II took some Tylenol which helped. It was there for almost two weeks and it gradually went down. The Lymph node under my arm also went down in the same amount of time. I am nervous about getting the second dose.
45 2021-04-08 feeling hot On Thursday 3/18 around 5:00 I started feeling tired, went to bed early woke up Friday with my eyes ... Read more
On Thursday 3/18 around 5:00 I started feeling tired, went to bed early woke up Friday with my eyes burning, the skin around my eyes was red, creapy, and was burning and itching. It was mainly my eyes, but my face felt puffy. My torso felt hot from inside. My throat felt swollen towards the top. By Friday night it was getting worse so I took Benadryl and sat with ice packs on my eyes, and put hydrocortisone around my eyes and eyelids. I continued that til Tuesday when it finally subsided. I did take pictures of my face, and I contacted my doctor to ask about the second shot. They advised against it, so I?ve cancelled my appointment. I might try the J & J shot in a few months.
45 2021-04-08 tremor, weakness Later the evening of the injection, I started feeling weak and sluggish. Otherwise felt ok. The nex... Read more
Later the evening of the injection, I started feeling weak and sluggish. Otherwise felt ok. The next day (Thurs 04/08) I still had a sluggish feeling, and my limbs felt weak, and I also started having a little trouble breathing- just like I was "winded", or couldn't quite catch my breath. It got worse that night, I couldn't take full breaths and when I did breath in I had a pain across my mid / upper back. I also experienced chills off and on. I took my temperature several times, which was normal. Today (Fri 04/09) I feel better, but still have a leftover sluggish feeling, and any kind of activity makes me short of breath and my limbs are weak and shaking. I have reported this to my primary doctor.
45 2021-04-09 weakness No adverse affect at time of injection. 2 hours later, began to have problems. Saturday April 10, ... Read more
No adverse affect at time of injection. 2 hours later, began to have problems. Saturday April 10, fatigue, dizzy, finally able to eat, still not feeling well, exhausted and weak
45 2021-04-09 facial paralysis, pain in extremity lip area looked a little droop; numbness around her mouth area that spread to the left cheek area; s... Read more
lip area looked a little droop; numbness around her mouth area that spread to the left cheek area; soreness/pain in the arm after the injection; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on 05Mar2021 (received at 45-years-old) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid 19 vaccine at noon on 05Mar2021. She stated that 18 hours later, when she woke up the next morning on 06Mar2021, she had numbness around her mouth area that spread to the left cheek area. She said it was like going to the dentist and getting local anesthesia for a filling. Her lip area looked a little droopy, but she wasn't sure. It continued the whole day and reduced the next day (07Mar2021). She also had soreness/pain in the arm after the injection (05Mar2021) and the next morning (06Mar2021). She further stated that her doctor wasn't sure if this was a one-time issue or related to the vaccine. Outcome of Her lip area looked a little droopy was recovering, while outcome of the other events was unknown. Information about batch/lot number has been requested.
45 2021-04-09 feeling cold Freezing, extreme body aches & tiredness. Started Thursday April 8 at 3am & lasted till Friday morni... Read more
Freezing, extreme body aches & tiredness. Started Thursday April 8 at 3am & lasted till Friday morning April 9 around 11am. Tylenol helped every 6 hours
45 2021-04-09 feeling hot Chills, then hot, body aches, severe headache, dizzy, nauseous.
45 2021-04-09 numbness, pain in extremity major breathing issues tight chest right arm numbness pain shooting down right arm right arm pit pai... Read more
major breathing issues tight chest right arm numbness pain shooting down right arm right arm pit pain neck/shoulder and back pain
45 2021-04-09 pain in extremity, burning sensation Throat got itchy; Pain in arm; Arm burned; This is a spontaneous report from a contactable consumer ... Read more
Throat got itchy; Pain in arm; Arm burned; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient reported for herself that she received received second dose ofBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6199, Expiration date: unknown) via an unspecified route of administration on 12Mar2021 on right arm at single dose for COVID-19 Immunization. Medical history included Asthma, sleep apnea, autoimmune and had allergies to medications, food, Tetneus shot, milk and erythromycin. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) on 19Feb2021 at 12:30 for covid-19 immunisation. The concomitant medication included Claritin. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 2:30, (two hours after second dose vaccination), patient experienced throat got itchy, and it lasted for a few hours, no breathing issue was reported just slightly itchy throat and pain in arm. Patient also had arm burned right after shot. Patient did not received any treatment for the events. The events were recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
45 2021-04-09 pain in extremity Hives; severe arm aches; itching; headache; This is a spontaneous report from a contactable other he... Read more
Hives; severe arm aches; itching; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL3246) via intramuscular in left arm on 05Feb2021 at 11:30 am as a single dose for COVID-19 immunization. Medical history included celiac disease and PCN allergies. The patient's concomitant medication included Cannabis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient was not tested for COVID-19. On 05Feb2021 at 12:45 pm, patient experienced hives, severe arm aches, itching and headache. Treatment provided for the events was unknown. Outcome of the events was recovering.
45 2021-04-10 breast pain Sore breasts - especially the one on vaccine side and painful nipples
45 2021-04-10 feeling cold, burning sensation, tremor Please see below for the worst symptoms that started on 4/9, but in chronological order here it is: ... Read more
Please see below for the worst symptoms that started on 4/9, but in chronological order here it is: 12 hours after receiving the vaccination: chills, body aches, headache and feeling of drunkenness, pressure in eyes, painful gums in mouth. On Thursday 4/8: muscle aches, chills, tiredness, pressure in head with drunkenness feeling again. On Friday 4/9 at ~ 2:30pm I got a sudden feeling of coldness and started shaking and teeth were chattering uncontrollably, my lips turned blue, this lasted for about 20 to 30 minutes. Headache and body aches continued. Measured fever of 100.5 degF. On Saturday 4/10: pressure in head intensified, feeling as if someone squeezing on head. Saturday night/early Sunday morning burning feeling in legs. sudden sweats. On Sunday 4/11 at time of writing, still feeling pressure in head, body aches, and chills.
45 2021-04-10 feeling jittery Sore arms Achy muscles Achy all over Stiff Joints Back Ache sharp pain in left arm where shot was ad... Read more
Sore arms Achy muscles Achy all over Stiff Joints Back Ache sharp pain in left arm where shot was administered drowsy/ sleepy Feeling Jittery Taste Buds are off (medicine taste or metallic taste in the mouth). Many of the symptoms or side affects begin to decrease after the 2nd or 3rd day.
45 2021-04-10 grand mal seizure, unresponsive to stimuli 45 y/o F with PMHx of vasovagal with seizure c/o not feeling well around 1:14 pm (which was 14 minut... Read more
45 y/o F with PMHx of vasovagal with seizure c/o not feeling well around 1:14 pm (which was 14 minutes after receiving her second dose of Pfizer vaccine). She began having a tonic-clonic seizure at 1:15 pm lasting around 90 seconds. Patient was post-ictal for approximately 1-2 minutes. When EMS and Clinical Leads were notified, patient was not actively seizing. Patient was not responsive to verbal stimuli while post-ictal. After ~3min pt was able to respond and follow verbal and tactile commands. Pt was c/o feeling tired / nauseous. Pt was AOx3 and able to follow commands. Patient was assessed by EMS and clin leads, she was placed on a stretcher, attached to monitor, vitals and BGM taken, 18g IV started on right hand and 20g IV access point attained on left hand. 15L NRB O2, 250mL NS bolus, 1L NS bolus Pt remained stable and transport was called, pt was transferred to hospital for further evaluation/workup. Pt's father accompanied pt to vaccination site and followed EMS to the hospital. 15L NRB O2, 250mL NS bolus, 1L NS bolus, 1L NS bolus started via transport Denies HA, numbness, weakness, parathesias, tingling, trauma, hitting her head, erythema/induration at injection site, palpitations, chest pain/tightness/heaviness, SOB, dyspnea, wheezing, facial or peripheral edema, cyanosis, hives, pruritis 2nd Pfizer dose administered @13:00pm, symptoms began @13:14pm, seizing began @13:15pm @1:25pm: HR 80bpm, SpO2: 100% NRB @15L @1:28pm: 3 lead: sinus arrhythmia with notched R waves in leads I, II, III, avR, avL, avF (unspecific QRS abnormality), notched p-waves in all leads, EKG not acutely concerning and patient is not actively infarcting @1:29pm: IV access with 18g @1:30pm: BGM: 99 @1:31pm: 12 lead @1:37pm: BP: 102/70 (manual large cuff on left arm) @1:42pm: BP: 80/50 (automatic large cuff on left arm) Lungs: clear to auscultation b/l, no respiratory distress, no wheezing, no rales cardiac: normal S1S2, rate, rhythm Eyes: PERRLA Throat: airway patent, no trismus Neuro: AOx3, sensation/motor/strength intact in all 4 extremities, Motor 5/5, DP/PT 2+ B/L
45 2021-04-10 hot flush, inability to speak Over the course of a few days after I slowly started to get a sore throat and hit flashes. By Saturd... Read more
Over the course of a few days after I slowly started to get a sore throat and hit flashes. By Saturday into Sunday of said week throat was so swollen it was hard to talk and swallow. Extremely painful. Hot flashes and high heart rate but no fever. Needed five days of 60 mg of prednisone to control throat swelling. After throat starts to feel better wide spread muscle aches out of no where and extreme fatigue ..
45 2021-04-10 pain in extremity Fever, severe headache, body aches, sore arm
45 2021-04-10 pain in extremity Muscle pain in upper arm started around 2 1/2 hours after injection. Pain got worse over the next 24... Read more
Muscle pain in upper arm started around 2 1/2 hours after injection. Pain got worse over the next 24 hrs then traveled to elbow. Elbow pain lasted around 2 days then traveled to upper part of lower arm. Severe pain in upper part of lower arm has lasted for 10 days so far. Took Ibuprofen on day 8 with no effect. The pain is like a burning, knife stabbing pain when arm is used or fully extended.
45 2021-04-10 tingling, pain in extremity Arm soreness and fatigue first two days. Several hours after the vaccine, experienced some paresthes... Read more
Arm soreness and fatigue first two days. Several hours after the vaccine, experienced some paresthesia in left arm/hand (same arm as shot). After 3 days the tingling/paraesthesia was more widespread to arm, fingers, and feet, mostly still on left side of body. No pain or burning as of day 4 but feeling of "pins and needles" continues.
45 2021-04-11 weakness, hot flush Headache, dizziness, weakness, fatigue, body aches, hot flashes
45 2021-04-11 breast pain On Day 1 of shot given just a few hours after shot, I started having chills, Tooth pain, burning nos... Read more
On Day 1 of shot given just a few hours after shot, I started having chills, Tooth pain, burning nostrils, burning throat. I went to sleep and later at 1 am in the morning I woke up and had an extremely painful sore throat. The next day (Day 2) began the severe chest congestion and nasal congestion. This interfered with my asthma and ability to breathe. I also had body aches, and severe nausea and headache. Each day the symptoms seemed to increase not get better. Day 3 was severe enough for me to contact my physician as I didn?t feel it should be getting worse. I also had Diarrhea on Day 3. Finally I started taking Sudafed on Day 3 which helped alleviate the congestion symptoms while taking but I could tell it wasn?t better when the medication would wear off. Day 4 the coughing was so severe my chest started to hurt and I started to have Armpit and breast pain under the arm on the side of the injection site. Day 5 I started to get a severe Ear Ache in my left ear. I cannot be up and out of bed for more than a few minutes or the nausea gets too severe. Day 6 is today and I called my Physician again. They agreed that the symptoms should not be lasting this long and had me rapid tested for Covid-19 which came back negative. I went in for an office visit and it appears I have a secondary infection in my throat (possibly caused by the drainage). They prescribed me Azithromyzcin for the infection, Cough syrup with codeine for the cough, and Zofran for the nausea. They told me to alternate Tylenol and ibuprofen for the other aches and pains and to call them Friday if symptoms do not improve. I have already missed 3 days of work and the doctor just wrote me a note for 3 days more off of work because I?m so nauseated I can?t move around.
45 2021-04-11 discomfort Mild flu like symptoms that gradually increased through the day - exhaustion, achy, uncomfortable, c... Read more
Mild flu like symptoms that gradually increased through the day - exhaustion, achy, uncomfortable, chills. Slept through the night and woke up very sweaty, like I'd broken a fever overnight. I did not take my temperature during the day
45 2021-04-11 involuntary muscle movements Describes a sensation of lightheadedness and anxiety after vaccine. Minutes later, this progressed ... Read more
Describes a sensation of lightheadedness and anxiety after vaccine. Minutes later, this progressed into "involuntary twitching" of all extremities. Patient was evaluated in urgent care, and ultimately thought to be a sympathetic surge. Patient was discharged without further complication. Submitting this primarily since patient required prolonged observation in urgent care setting.
45 2021-04-11 feeling hot, tingling, pain in extremity Felt hot all over, left arm pain. Tingling left little and index finger.
45 2021-04-11 pain in extremity Extreme fatigue after fourth hour. Bodyaches including neck, shoulder, down my entire back. Swelling... Read more
Extreme fatigue after fourth hour. Bodyaches including neck, shoulder, down my entire back. Swelling in both hand joints and soft tissue. Pain in both wrists, pain shooting down my R Arm (injection arm), wheezing/asthma symptoms. On the 5th day after the first dose, injection site is throbbing painfully, especially at night. Massage, hydrating, heat, cold compress, and CBD roll-on ointment does not alleviate the pain. Pain has been occurring nightly for 5 nights now.
45 2021-04-11 tingling, numbness Tingling to numbing sensation along left arm into fingers of left hand particularly in my index, mid... Read more
Tingling to numbing sensation along left arm into fingers of left hand particularly in my index, middle and ring fingers. This occurrence happened about 30 minutes after the injection however the numbness is still felt in my fingers today, 4/12 still primarily in the index, middle, and ring fingers. I also experience swelling, size of golf ball at the injection site apparent about twelve hours after the shot. The injection site was sensitive to touch about 3 hours after the shot then gradually becoming worse as the day progressed peaking after 24 hours. It's still tender to touch on 4/12 but only when pressure is applied to the area.
45 2021-04-11 tingling tingling/numbness in right fingers
45 2021-04-11 tremor About 10 hours after my second dose of Pfizer I got a horrible headache, body aches, uncontrollable ... Read more
About 10 hours after my second dose of Pfizer I got a horrible headache, body aches, uncontrollable chills/shaking, and fever reaching 103 degrees. This lasted for about 12 hours. Following that, I just had body aches and a headache until approximately 30 hours after the shot during which time the fever came back to 102 degrees, chills, and vomiting. This lasted for 10 more hours ending approximately 40 hours after the injection of the vaccine.
45 2021-04-12 slurring Patient began to feel light headed after vaccine administration and then began to slur speech and sh... Read more
Patient began to feel light headed after vaccine administration and then began to slur speech and show diminished cognitive function. Patient the stopped responding and breathing continued to diminish with lips starting to change color within 5 minutes. 911 was called. Patient was given Epinephrine 0.3 mg in left upper leg. Patient started to respond and regained consciousness. Patient continued to talk and EMT showed up 3-5 minutes later. Blood pressure was taken by them and was reported as low to patient. Was told she needed to go to hospital. They wanted to drive themselves. Patient took a bendaryl that was given to her by husband. Patient left for hospital per husband. Patient had reported fasting for the entire day. Water was given with a glucose tablet.
45 2021-04-12 feeling hot, tingling, flushing Right after I had tingling in arm and roof of mouth, but my face became very flushed and hot, I coul... Read more
Right after I had tingling in arm and roof of mouth, but my face became very flushed and hot, I could breath fine so didn?t report..had window down and air conditioning on to try and cool off lasted about 25 minutes, after I had neck pain and headache for a week then a week later had high blood pressure and pulse. After 8 days I finally started feeling better
45 2021-04-12 feeling jittery 15 minutes after dose she was "jittery". Had had feeling before in the past. Pt states She has a ho... Read more
15 minutes after dose she was "jittery". Had had feeling before in the past. Pt states She has a horseshoe kidney and as a result is sensitive to medications. Denies cardiac issues, but later stated she had a longstanding hx of sinus tachycardia for which she had workups by her PCP and cardiologist. Did have two cups coffee prior to injection. pulse 130, saturation and BP WNL, LS CTA, heart tachy but regular. EKG done ST rate=105. Monitored closely until HR was 110. Sent home after rest to FU with PCP and with ED precautions (to go to ED if worse).
45 2021-04-12 sensory loss, throat numbness, feeling hot, numbness client reported numbness to face and throat after receiving 1st Pfizer Covid Vaccine (Lot#EW0161 Exp... Read more
client reported numbness to face and throat after receiving 1st Pfizer Covid Vaccine (Lot#EW0161 Exp.4/14/21). Client had completed 15 min observation period when she alerted EMT she was feeling numbness to her face and throat. Warmth sensation that passed through right side of body for a few seconds and was gone. PHN also responded. Offered client to contact paramedics for further assessment. Client denied, wanted to just stay longer in observation. Client alert and oriented, denied shortness of breath, no trouble swallowing. Vitals at 1341: blood pressure 130/90, pulse 78, oxygen 97%. PHN joined staff. Per client felt a sensation "like when you get anesthesia at the dentist". Feeling at this time only at cheeks and nose. Throat no longer affected, warm sensation had resolved. Me history of allergies. Medical history of lupus and kidney problems secondary to lupus. Current medication: Myfortic and lisinopril. PHN assessed for face flushing and swelling. Client able to answer all questions with no problem and denied shortness of breath. Client informed we could keep 30 mins for further observation. Vitals at 1448: blood pressure: 130/90, pulse 75, oxygen 97%. Client stated sensation returning and smaller area affected now. Denied shortness of breath, no redness or swelling noted. Vitals at 1358: blood pressure: 130/80, pulse 79, oxygen 99%. Per client more improvement. Client advised to speak with provider before second dose. Last vitals at 1408: blood pressure: 126/80, pulse 70, oxygen 98%. Per client sensation almost back completely. Affected area only tip of nose and maxillary sinus area. Client stated well to leave facility. Per client family member waiting outside and would be driving. ER precautions given. Client left facility at 1411 with steady gait.
45 2021-04-12 tenderness I had mild symptoms after both doses on December 15,2020 and second dose January 4 2021 as a healthc... Read more
I had mild symptoms after both doses on December 15,2020 and second dose January 4 2021 as a healthcare worker I was one of the first to get vaccinated March 29 I palpated a right axillary lymph node over 2 cm and tender Had a biopsy on 3/31 necrotizing lymphadenitis In the contra lateral axilla from vaccination All ID and malignancy work up is negative This is strange as it appeared almost 4 months after the first dose but reporting to alert others
45 2021-04-12 tremor, flushing, tingling Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: tingling L ha... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: tingling L hand, feeling prickly, hot-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
45 2021-04-13 bell's palsy Bells Palsy
45 2021-04-13 breast pain Severe Lymph node pain and pain radiating into my breasts. Under my breasts. Sides of breasts. Subsi... Read more
Severe Lymph node pain and pain radiating into my breasts. Under my breasts. Sides of breasts. Subsided after a week but still have a bit of pain nearly 3 weeks later. Went into doctor for manual breast exam. No lumps. This is almost certainly from the vaccine. The pain in both breasts was shifting through all the lymph drainage areas. I expect it to completely be gone by the time I get a mammogram in a month. It has improved a lot. I also had a headache and fatigue.
45 2021-04-13 feeling hot Severe headaches, nausea, dizziness, overheating, tired for several days. Eyesight seems strange too... Read more
Severe headaches, nausea, dizziness, overheating, tired for several days. Eyesight seems strange too.
45 2021-04-13 flushing, pain in extremity Received 2nd dose of the Pfizer-BioNTech vaccination at 12:00 noon on 4/12, ate lunch, and by 2:30 p... Read more
Received 2nd dose of the Pfizer-BioNTech vaccination at 12:00 noon on 4/12, ate lunch, and by 2:30 pm felt flush in face, headache, achy, and tiredness - general feeling of being unwell. Sore arm from the site of the injection. These symptoms continued all day on 4/12 and 4/13. I felt better on 4/14 when I woke up.
45 2021-04-13 numbness, tingling The patient reports an episode lasting approxiately 5 minutes where she developed numbness and tingl... Read more
The patient reports an episode lasting approxiately 5 minutes where she developed numbness and tingling in both hands and was unable to grasp objects. The patient presented to the clinic and was referred to the ED for further evaluation.
45 2021-04-13 muscle twitching twitching of lower lip on 04/02/21, progressed to upper lip on 04/05/21, progressed to tongue on 04/... Read more
twitching of lower lip on 04/02/21, progressed to upper lip on 04/05/21, progressed to tongue on 04/09/21, progressed to roof of mouth & back of throat on 04/11/21
45 2021-04-13 pain in extremity, hypersensitivity of all senses, tingling My right arm is where I had the 2nd shot administered (used Left arm for dose #1). I had my shot at... Read more
My right arm is where I had the 2nd shot administered (used Left arm for dose #1). I had my shot at 1:30pm on 4/12/21 and noticed sore arm pain throughout the day. Tuesday 4/13/21 at 9am my entire body began to ache and was sensitive to touch and I was tired. Tuesday evening at 10pm 4/13/21 my right armpit began to ache. The aching remained all night and all day into Wednesday 4/14/21. I can feel a lump (assuming lymph node) under my armpit. It has become more painful to move as the day goes on. I have also had some tingling in my right arm and lower back pain.
45 2021-04-13 pain in extremity Woke up around 2am with intense body aches - unable to get comfortable or sleep. For the next 24 ho... Read more
Woke up around 2am with intense body aches - unable to get comfortable or sleep. For the next 24 hours had body aches, muscle fatigue and severe headache. Once symptoms improved they improved substantially. The next day my head hurt only when I would bend down (e.g. to pick something up off the floor), and my fingers hurt when I was typing. The day after that, good as new.
45 2021-04-14 numbness, tingling Numb, tingling face; difficulty breathing; increased heart rate; tunnel vision
45 2021-04-14 migraine I have had joint pain in my shoulders for six weeks straight and then intermittently for weeks afte... Read more
I have had joint pain in my shoulders for six weeks straight and then intermittently for weeks after that. The pain is bilateral, and I have never had joint pain before. I had also had right upper quadrant pain in the two weeks after the second dose that is still bothering me on occasion. I am constantly nauseated, and my reflux was out of control. That seems to be resolved. I got tested after I experienced chest pain and my Potassium was very low. My EKG indicated a heart problem. That was seven weeks after my shot. Now my fingers turning white on both hands. I also had an issue with late periods. I was one week late after the first shot and two weeks late after the second shot. I have chronic migraines and since my vaccines I have had long lasting migraines that have lasted up to ten days. I have had multiple visits to the Urgent care and my primary care doctor. I have a GI scope scheduled 04/26/2021.
45 2021-04-14 night sweats A red hive like rash on my trunk area, below my bra line on both my stomach and back appeared today.... Read more
A red hive like rash on my trunk area, below my bra line on both my stomach and back appeared today. I noticed it around 11:30am when I got out of the shower. Also during the night I had extreme sweating where my pajamas were very wet. This was after having more typical reactions the past 24 hours of muscle & joint pain, headache, chills, fever and fatigue. I called my primary care Dr and talked to the nurse, and she had my Dr call me back. My Dr told me to take an Antihistamine and how to report the side effect. I still have the rash currently.
45 2021-04-14 pain in extremity 9 days after shot I have extreme and debilitating arm pain. I can?t move my arm up above my head an... Read more
9 days after shot I have extreme and debilitating arm pain. I can?t move my arm up above my head and up to my side in alignment with my shoulder. My bicep is working fine. Bilateral raises are very painful and difficult. Today is Thursday and I have no improvement today
45 2021-04-14 pain in extremity Within 20 minutes of getting my second dose shot my head felt very cloudy and weird. By 9:30pm that... Read more
Within 20 minutes of getting my second dose shot my head felt very cloudy and weird. By 9:30pm that evening I was extremely tired and starting to ache. I had a hard time sleeping and getting comfortable that night and woke up the next morning with a terrible headache and a very very sore arm. By noon I felt like I was not able to function. I had severe chills (it felt like someone had drilled a hole in my head and was pouring ice water into it that would then run the length of my body). My head hurt and every joint in my body ached. I alternated between sleeping and crying. Around 10:30pm my chills finally broke and the sweats started and continued through the next morning. By noon on 4/15 I was feeling back to normal.
45 2021-04-14 tension headache I immediately had a pain in my chest that went into my stomach and I felt dizzy. My chest felt tight... Read more
I immediately had a pain in my chest that went into my stomach and I felt dizzy. My chest felt tight. I had a sun burn rash later that night the next day my eye lid swelled. That night I couldn't lift my arm. My chest pain has been on and off since then. VERY Tired! Pain all over my body. BAD headache.
45 2021-04-15 weakness Nausea, headache, Weakness, Aches and Pains, minor throat irritation, & minor nasal congestion
45 2021-04-15 weakness Severe flu like symptoms. Woke up with body so sore it was hard to get out of bed. Severe chills. Fe... Read more
Severe flu like symptoms. Woke up with body so sore it was hard to get out of bed. Severe chills. Fever. Headache. Vomited about 16 hours after shot. Slept for 19 hours out of 24 hours. Got shot on 4/12/21 at 11:20 AM, on 4/14/21 woke up to a sweaty shirt, fever broke. When taking a shower the same morning, I found a baseball/softball size lump between my breast and armpit on my right side. The same side as my shot. My right arm also had redness, and a small bump where the shot was given. It was extremely sore. Currently it is 4/16/21 and although the symptoms are getting progressively better, and significantly mild, I am still sore, have low energy and the lump is still there. I did not have any reaction other than a slightly sore arm to the first dose.
45 2021-04-15 breast pain I had my first dose of Covid vaccine, Pfizer 30ug at 3:40pm on 4/8/21. 1 day after my first dose I s... Read more
I had my first dose of Covid vaccine, Pfizer 30ug at 3:40pm on 4/8/21. 1 day after my first dose I started have low fever(98.8-99.2f). 2 days after my first dose of Covid vaccine my left breast start being painful and start whole body ache. 4 days after first dose my left breast start having an half egg size painful touchable lump with red, warm and swelling. I started taking Acetaminophen 10 mg bid. 4 days on 4/11 till today after first dose for both pain control and reducing body temperature. I used to have granulomatous mastitis on my right breast which is self limited and I had not have this problem for one year. Although the mechanism is still unclear but some theory of this disease is more like an autoimmune problem. I doubt somehow this vaccine has too strong immunogenicity, or at least which is too strong for me. I was getting Pfizer which is 30ug I think. Possibility: 1 Too large dose for my body size (120 lb) 2 Some adjuvant in this Pfizer vaccine induces too strong cellular immune response which may initiate or help for some none Covid specific antibody production, unfortunately for some patients who have autoimmune disease are triggered by this vaccine then they may start producing autoimmune antibody which start self attacking.
45 2021-04-15 breast pain Chest/breast swelling and pain
45 2021-04-15 slurring From ED Physician's Note 4/16/2021: 45 yr female presents to ER complaining of left arm and leg fee... Read more
From ED Physician's Note 4/16/2021: 45 yr female presents to ER complaining of left arm and leg feeling heavy since yesterday (4/15/2021) morning. Patient states she got the Pfizer first vaccine on Wednesday (4/14/2021) morning, felt fine throughout the day, went to bed without any problems or symptoms. Patient states she awoke yesterday morning feeling as if she was" drunk". Patient states she feels like her left arm and leg are heavy and at times is having slurred speech. Patient states she feels like her walking is off and that she is dragging her left leg. Patient denies any numbness and tingling in the upper or lower extremities. Patient denies any headache or dizziness, vision changes, fever, chills, body ache, infectious respiratory symptoms, chest pain or shortness of breath.
45 2021-04-15 hypersensitivity of all senses, numbness Lips and area around lips went numb about a half hour after the 2nd vaccine was administered. Numbn... Read more
Lips and area around lips went numb about a half hour after the 2nd vaccine was administered. Numbness migrated to my left cheek a couple of hours later and was gone by about noon. Elevated temperature around 5pm (99.8) the day of vaccination. Started taking Tylenol. Temperature the following day (100.9) and whole body skin sensitivity. Slight temperature returned the next day (99.8), and no additional symptoms so far after a week.
45 2021-04-15 migraine She reports that the following morning she woke up with fever and chills That night, she had trouble... Read more
She reports that the following morning she woke up with fever and chills That night, she had trouble breathing so tried albuterol nebulizer without relief. She administered her epipen with improvement. She continued albuterol and prednisone. For the following week, she has had persistent migraine and vomiting which she has been taking NSAIDs and anti-emetics.
45 2021-04-15 tremor, weakness Dizzy after first injection for 12 hours. Dizzy and throat tightness approx 1 hour after 2nd inject... Read more
Dizzy after first injection for 12 hours. Dizzy and throat tightness approx 1 hour after 2nd injection. Took inhaler with relief. Approx 1030pm stomach gurgling, abdominal pains , diarrhea started. 11pm fever 102 started and severe shaking chills. Fever continued until 4/15 530am despite Motrin. 4/14 early morning hours noticed face bright red like a beet and swollen. Throat tight and cough. Took Benedryl and Pepcid every 4 hours along with Motrin. My primary care had no appointments, tried urgent care and they referred me to ED. I was so sick I couldn?t sit up and go to ED. Watched pulse ox and vitals at home. Got a telehealth appointment 4/16 today with my doctor. Told to continue Benedryl every 4-6 hours until all symptoms are gone. Continue with headache, weakness, dizziness, throat tightness on and off, lack of appetite and mild abdominal pain today. Lost 4-5 pounds since Tuesday.
45 2021-04-16 pain in extremity, face paralysis, numbness numbness and weakness around my mouth and my left cheek area; numbness and weakness around my mouth ... Read more
numbness and weakness around my mouth and my left cheek area; numbness and weakness around my mouth and my left cheek area; sore arm; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 45-year-old female patient (not pregnant, age at vaccination: 45-year-old) received bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 vaccine, lot EN6205), via an unspecified route of administration in right arm on 05Mar2021 12:00 as SINGLE DOSE for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and weakness around his mouth and left cheek area (no treatment) on 06Mar2021 06:00. She also had sore arm on 05Mar2021. The outcome of facial numbness was recovered; for other events was unknown. No follow up attempts needed. Lot number obtained.
45 2021-04-16 pain in extremity Arm sore within 2-3 hours Within 18-20 hours feel terrible. Constant headache, chills and a bit shak... Read more
Arm sore within 2-3 hours Within 18-20 hours feel terrible. Constant headache, chills and a bit shaky, no fever but goosebumps all over, all of skin is uncomfortable when touched or clothes rub too hard, jaw sore and feels uncoordinated, aches and pains come and go all over body (legs, lower back, neck, arms), nausea, send ivory to light and sound
45 2021-04-16 tingling, difficulty speaking, hot flush, night sweats 9:20 shot 9:30 tingling in fingers on left hand 10:30 tingling, swollen tongue; tingling in chest ... Read more
9:20 shot 9:30 tingling in fingers on left hand 10:30 tingling, swollen tongue; tingling in chest and right arm 11:00 tingling in head, thirsty 17:00 arm and joints pain chemical odor in urine 3/30 next day: 0700 mild fatigue, thirsty 1300 itchy under skin 1700 upset stomach 3/31 dark circles under eyes; dry cough, hoarse voice, red eyes, sinus congestion, headache shooting from sinuses around the right to back of head 4/3-4/4 migraine, night sweats, periodic hot flashes itching under skin for a few days after shot
45 2021-04-16 tenderness 15Apr 11:30pm: chills, fever 16Apr 8am: body aches, headache (chills continue) 16Apr 11:30am: arm te... Read more
15Apr 11:30pm: chills, fever 16Apr 8am: body aches, headache (chills continue) 16Apr 11:30am: arm tenderness, headache continues but other symptoms subside 16Apr 8pm: body aches, slight fever; headache subsides 17Apr: 7am other symptoms subside; noted a red, raised area at injection site. 2.5inches wide, 1.5 inches tall, irregular borders. Soreness under the armpit at the lymph node area, no noticeable swelling in that area.
45 2021-04-17 feeling hot During Observation period member complained of itching in throat and arms and upper body, felt hot a... Read more
During Observation period member complained of itching in throat and arms and upper body, felt hot and dizzy. PO Benadryl 25 mg administered - symptoms continued to worsen with patient complaining of increased throat "burning" and tight feeling in chest. Administered additional 25 mg benedryl PO and member transported to hospital via EMS
45 2021-04-17 pain in extremity Burning leg pain everyday and periodically arm pain
45 2021-04-17 tingling Immediate dizziness and continued sporadic dizziness with tingling in hands and feet.
45 2021-04-18 weakness, inability to speak, slow speech Noted Reaction Type Reactions Pfizer Covid-19 Vaccine [covid-19 Vacc,mrna(pfizer)(pf)] Allergy/hyper... Read more
Noted Reaction Type Reactions Pfizer Covid-19 Vaccine [covid-19 Vacc,mrna(pfizer)(pf)] Allergy/hypersensitivity Heart racing, couldn't talk, felt need to pass out, felt weak, and not able to talk because tongue felt heavier As of 04/16/2021 still complaining of Now having palpitations, feeling weak--- this happened again on the following Sunday, again for few minutes Has chest uncomfortable but no chest pain Felt like her speech was slower
45 2021-04-18 difficulty speaking, tremor, weakness 15 minutes after the injection I had an intense allergic/anaphylactic reaction. I was watched and t... Read more
15 minutes after the injection I had an intense allergic/anaphylactic reaction. I was watched and treated on site by EMS for 2 hours with Benadryl, oxygen and rest. We did not use epi because I was still able to breath (minus some wheezing, coughing, hoarseness and lung irritation). I felt the reaction hit when I started seeing green spots and my vitals dramatically increased (BP 181/111, HR 142 and weak). I then experienced the following symptoms: rash/hives on neck and chest, fatigue and weakness, dizzy and lightheaded and needed wheelchair for moving around, chills and shaking, blurry vision, nausea, stomach pain, headache, chest pain and increased urination. I also had elevated glucose (147). During those two hours my vitals decreased a little, but the rest of my symptoms persisted. I was not getting better and my vitals started to increase again at the two hour mark so EMS called an ambulance and transported me to hospital. I was treated with solumedrol and observed for several hours. The meds helped enough to send me home. (I did have to continue taking Benadryl at home that night and the next day because I continued to have an allergic response). I also had severe injection site pain and bruising.
45 2021-04-18 numbness, tingling My arm from shoulder to finger tips started tingling, then pins and needles, then going numb. My fac... Read more
My arm from shoulder to finger tips started tingling, then pins and needles, then going numb. My face started to feel tight like you feel with a bad sunburn. Then my face started tingling with pins and needles, my lips went numb, I started getting red splotches across my face spreading down my neck. I quickly got home and took Benadryl for the next 24 hours.
45 2021-04-18 numbness, throat numbness Caller states that she received her first dose of PFIZER at COVID facility this am. She sat for the ... Read more
Caller states that she received her first dose of PFIZER at COVID facility this am. She sat for the recommended 15 minutes and started to feel dizzy, they gave her water and she left. Once she arrived home she stated that she was still feeling dizzy and that her cheek has become numb and red and it feels like it is going toward her throat. Advised caller to see immediate medical care at an urgent care or ED to r/o a severe reaction, and that if her breathing became difficult or throat felt like it was closing to call 911. Caller verbalized understanding and is seeking immediate care.
45 2021-04-18 numbness Numbness and tingling in face ~45 min after shot, started with left side, then included mouth, went ... Read more
Numbness and tingling in face ~45 min after shot, started with left side, then included mouth, went away after ~15 min, and came back off and on a few times over next few days; extremely swollen lymph node on left side, noticed ~45 min after shot, went away by next day; headache, minor aches in joints for 1 night
45 2021-04-18 numbness Client reported feeling numbness in the face after receiving the first dose of Pfizer vaccine.
45 2021-04-18 migraine Woke up at 0500 with extreme headache and took Ibuprofen for relief, ate yogurt and cereal bar and d... Read more
Woke up at 0500 with extreme headache and took Ibuprofen for relief, ate yogurt and cereal bar and departed for work. At work headache became more vigorous and became lightheaded and nausea went back to classroom and walked into room and blacked out on floor. Blacked out for approx. 2 minutes and started to come to with blurriness in peripheral, nausea set in strong...Medics arrived on scene and took BP which was 180 over 120 (never been that high). Was taken to Hospital via ambulance, Labs taken, CT of head and chest and pain meds for headache administered. Course of time of approx. 5 hrs, doctor stated possible migraine triggered episode and was discharged. (Never had migraines before)
45 2021-04-18 pain in extremity I have had the same that most people complain about, soreness of arm, but nothing that concerned me.... Read more
I have had the same that most people complain about, soreness of arm, but nothing that concerned me. I have noticed changes to my vision and after one week, developing headaches that are not going away even with Motrin. I have also noticed after a few days after the shot a strange reaction, like if my heart jumped a beat and I had shortness of breath. It would be only one or two second episodes at a time, so I'm not too concerned, but if it continues, I will discuss this with my doctor. I had never felt that before. This is not chest pains, it's difficult to describe. It's like the heart has to "jump" a beat.. but only once or twice. It's scary, but it does not happen often and it's happening less in the past day. The headaches are not fun, but I hope they will go away after a few weeks. I don't suffer migranes or headaches on a regular basis.
45 2021-04-18 tingling, feeling hot A few minutes after the shot was administered while sitting in the waiting area I started to feel he... Read more
A few minutes after the shot was administered while sitting in the waiting area I started to feel heat at the injection site. The heat and tingling feeling spread across my back, my chest and up my neck. I instantly thought I was going to throw up or pass out. I alerted the volunteers and a nurse provided a bottle of water. I drank most of the water and felt well enough to drive home after 15 minutes. Felt a little nauseous but no other side effects or symptoms after this event.
45 2021-04-18 tenderness, pain in extremity Sore right arm. Hurt to touch and move. Major fatigue
45 2021-04-19 discomfort Rash on legs, arms, chest (hives?) for 6 days. Moderate discomfort. I am not sure if it is from... Read more
Rash on legs, arms, chest (hives?) for 6 days. Moderate discomfort. I am not sure if it is from the vaccine. NP prescribed Prednisone and suggested reporting symptoms. NP should be able to provide more detail as to the rash (diagnosis was e-visit through photos and phone). Injection sight had no issues (no pain\rash at injection site)
45 2021-04-19 facial pain, tingling, numbness 4/15 day of vaccine: intense headache 4/16-4/18: bouts of intense pain across face and jaw and sin... Read more
4/15 day of vaccine: intense headache 4/16-4/18: bouts of intense pain across face and jaw and sinuses...preceded and followed by tingling and numbness in face 4/19. Symptoms went away
45 2021-04-19 numbness Left-side facial numbness. Patient saw her PCP. She is slowly improving but still has some numbness.
45 2021-04-19 night sweats Got shot noon Thursday no adverse effects besides moderately tired until 3pm Friday. Then fatigue s... Read more
Got shot noon Thursday no adverse effects besides moderately tired until 3pm Friday. Then fatigue set in, headache, fever of 101, and lymph nodes in left arm very tender and swollen to size of goofball. Night sweats on Friday night and struggling to sleep because of tenderness under arm. Saturday morning adding left lymph node in collarbone area swollen. Both were swollen the size of eggs, warm to the touch and very tender. But no more fever. However still fatigued. The injection site still warm, slightly swollen, and patches of red on left arm. For 5 days my left arm ached, tingling and began to feel numb. Used ibuprofen, Tylenol, cool and warm compresses, and slept a lot. Woke Monday to now adding right collarbone lymph node starting to swell. Called Dr on Monday and went in at 4:30pm. Just continued same home treatment understanding it may take weeks to get back to normal.
45 2021-04-19 pain in extremity Developed pain in arm approximately 1-1/2 to 2 hours after injection which became severe after sever... Read more
Developed pain in arm approximately 1-1/2 to 2 hours after injection which became severe after several hours. Approximately five hours after injection, developed headache, sinus pain and congestion, joint pain, muscle aches and contractions, chills, fever 103°, loss of taste, gout flare-up, and fatigue. Symptoms persisted for approximately 36 hours. Self-treated with tylenol, OTC nasal decongestant, ice (for arm pain) and lots of water and sleep.
45 2021-04-19 tingling, numbness 5 min after short lips tingling moved to chin and nose. Within 25 minutes my entire face was tinglin... Read more
5 min after short lips tingling moved to chin and nose. Within 25 minutes my entire face was tingling. Within 30 minutes my thighs were numb on the top only. Similar reaction when I gave platelets. My face tingling lasted 5 hours. My thighs lasted 12 hours
45 2021-04-20 weakness Dizziness, nauseous, allergy symptoms (runny nose, watery eyes, sneezing, weak) Symptoms lasted two ... Read more
Dizziness, nauseous, allergy symptoms (runny nose, watery eyes, sneezing, weak) Symptoms lasted two full days.
45 2021-04-20 difficulty speaking 3/31/21: Shot @ 11:10am; Asked for paramedics @ 11:24am - throat tightening, itching throat (inner ... Read more
3/31/21: Shot @ 11:10am; Asked for paramedics @ 11:24am - throat tightening, itching throat (inner sides of neck), difficult to swallow, some vocal hoarseness; Paramedics eval. - High BP, fast pulse, no facial swelling or hiving or difficulty breathing. Paramedics cont. to eval BP and pulse until stabilized. Most symptoms resolved. Itching throat/inner sides of neck still present but much less severe. Signed papers to decline hospital transport at 11:45am. I (Pt) remained in the general area for another 30 minutes.
45 2021-04-20 facial pain, numbness About 5 mins after vaccine administration at 1135 am, the individual complained of R side of head nu... Read more
About 5 mins after vaccine administration at 1135 am, the individual complained of R side of head numbness, "feels like a balloon". Also experiencing pain at same site and spreading to the nasal area and R side of face and also the forehead. No other sxs. Provided some juice since she did not eat this am per client. Pulse ox 96-97%. HR rate within acceptable ranges, 60-74/min. Continue to assess sxs and monitor for any other issues. No facial swelling, or any type of asymmetry is absent. Alert and oriented to name, address and place. The symptoms of the numbness feeling and pain is still the same after 40 mins. Pt instructed to call physician but declined. Instructed that we will call 911 and educate her the reason. At 1220, 911 was called. EMT arrived at 1228. the client refused to go to the hospital for further assessment. The client remains stable and felt a little better. Ambulatory and d/c in stable status, accompanied with staff member.
45 2021-04-20 numbness Numbness in left arm radiating to fingers. First BP 123/78, O2Sat 98 and HR 87. Second 129/76, 99 an... Read more
Numbness in left arm radiating to fingers. First BP 123/78, O2Sat 98 and HR 87. Second 129/76, 99 and 90
45 2021-04-20 myelitis transverse Approximately 3 days after receiving the vaccine she developed bilateral lower extremity paralysis.
45 2021-04-20 pain in extremity I had fever,body pains and sore arm for 2 days . Slight itchiness, rash started on 3rd day and start... Read more
I had fever,body pains and sore arm for 2 days . Slight itchiness, rash started on 3rd day and started increasing with swollen face, rash increasing and itchiness. Took OTC drugs for couple of days but didn?t help much. Visited the doctor and they prescribed steroids.
45 2021-04-20 pain in extremity Bad aches in my joints. Even my feet and hands hurt. No fever but felt like a fever. I took ibuprof... Read more
Bad aches in my joints. Even my feet and hands hurt. No fever but felt like a fever. I took ibuprofen and Tylenol throughout the day. I felt much better the next morning.
45 2021-04-20 pain in extremity Fatigue the next day, sore arm from time of injection for about 3 days after first shot. 2nd shot? j... Read more
Fatigue the next day, sore arm from time of injection for about 3 days after first shot. 2nd shot? just sore arm for a day.
45 2021-04-21 burning sensation Severe allergic reaction - Hives, Itching, Burning, loss of breath, fainting I was unable to sit or ... Read more
Severe allergic reaction - Hives, Itching, Burning, loss of breath, fainting I was unable to sit or stand. So my husband called ambulance and they took me to emergency room
45 2021-04-21 pain in extremity Pt started having PVCs, pitting edema, fatigue, arm pain, brain fog and bradycardia the day after va... Read more
Pt started having PVCs, pitting edema, fatigue, arm pain, brain fog and bradycardia the day after vaccination. Symptoms persisted fo 10 days before slowly starting to improved. Still c/o feeling fatigued and foggy 3 weeks later.
45 2021-04-21 tingling, numbness, pain in extremity, speech disorder arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist.... Read more
arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist. immediately that area swelled up and turned red. today (4/22) it is still significantly swollen, though swelling has decreased. also immediately felt "spacey" and feet and forehead felt tingly. within 30 minutes it felt odd to walk because legs/feet felt a bit numb. the spacey feeling stayed for 6 full days during which i felt exactly the same as i had when i had a concussion about 6 years ago. i could think but i couldn't multi-task, communicate well, focus well, speak normally. it's hard to explain but it felt like i had a concussion and it was really scary. i tried to drive at day 6 and realized i could not do it. by day 7, my head started to clear up and i felt better mentally.
45 2021-04-21 tingling, muscle spasms Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm ... Read more
Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm pain around her injection site. Soon thereafter, she developed left sided neck pain. She describes a pulling sensation associated with stiffening. Moving the neck was difficult, and the pain was severe. The tightness worsened. She became concerned because she had a dystonic reaction to phenothiazine in high school that felt similar. She has also noted involvement of her left leg as well, with stiffness and tightness. She has had no fevers, no chills, an occasional headache, no vomiting. No loss of consciousness. She has had some nausea associated with the pain. She presented to the emergency department on 4/17 for these symptoms. On 4/18 she developed diffuse skin sensitivity and all over muscle aches that "feel like the flu" - these felt different than the muscle spasms described previously. On 4/19 at approximately 3am she acutely developed weakness in both arms and legs, with associated paresthesia in the feet bilaterally and continued muscle aches. She also reported difficulty swallowing liquids and pills. Muscle pain and spasms responded to baclofen, diphenhydramine, and diazepam, but she continued to have weakness of the bilateral legs with some ability to move them anti-gravity but requiring assistance to walk. Physical and occupational therapy evaluation was performed, and inpatient rehabilitation is recommended to continue regaining strength.
45 2021-04-22 flushing Patient received Pfizer COVID vaccine and immediately felt flushed. She felt like her heart was raci... Read more
Patient received Pfizer COVID vaccine and immediately felt flushed. She felt like her heart was racing and palpitating. Patient also reported trouble breathing. Vitals stable. EMS was called and she left with EMS.
45 2021-04-22 numbness HPI: Patient is a * year old * who presents following administration of the first dose of Pfizer COV... Read more
HPI: Patient is a * year old * who presents following administration of the first dose of Pfizer COVID19 vaccine in the left deltoid. She states that she started to experience numbness on the left neck, face, and ear. She denies altered sensation in the left arm, left shoulder, and other body parts. She denies muscle weakness and loss of consciousness. She relates that she has never experienced this following a vaccination. She affirms allergies to shellfish, iodine, and naproxen. She denies a past medical history. She denies taking medications on a regular basis. She relates she has only drank coffee this morning, no food or water. She denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. Exam: GEN: Alert and oriented x 4, NAD HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: No rashes, skin warm and dry. No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 5 demonstrates decreased touch sensation in the left side. No obvious muscle weakness. CN 2-4 and 6-12 grossly intact, no ataxia, gait steady Clinical Impression/Field Tx: Paresthesias without muscle weakness of the left face and neck region. Patient demonstrated no obvious signs or symptoms of anaphylaxis that required Patient able to adequately control airway and secretions. Thorough neuro exam conducted and was within normal limits with the exception of decreased sensation in the left face/neck compared to the right. Remainder of exam otherwise normal. Vital signs stable. Instructed patient to consult their PCP regarding the post-vaccination reaction. Patient instructed to go to emergency department should they develop muscle weakness, increasing areas of numbness, chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting. Medications administered: None Disposition: Home
45 2021-04-22 migraine 15 days after first shot (April 10), experienced migraine with aura, had 4 of the same episodes in t... Read more
15 days after first shot (April 10), experienced migraine with aura, had 4 of the same episodes in the same week, also including vertigo, nausea, fatigue. Also began menstruating in this month two weeks early, with an unusual flow.
45 2021-04-22 pain in extremity pain and pulling sensation under my arm. uncomfortable sensation in chest, back. moderate pain and s... Read more
pain and pulling sensation under my arm. uncomfortable sensation in chest, back. moderate pain and swelling in arm, chest and back that lasted 4 days. severe headache lethargy, fogging /hangover sensation
45 2021-04-23 burning sensation Severe Low back pain and stiffness, cannot sit Severe shoulder pain, burning, pain in armpit, cannot... Read more
Severe Low back pain and stiffness, cannot sit Severe shoulder pain, burning, pain in armpit, cannot lift arm
45 2021-04-23 involuntary muscle movements adverse events- muscle tics, and involuntary movement
45 2021-04-23 feeling cold Severe abdominal pain with bloody diarrhea, vomiting, chills for 14 hours
45 2021-04-23 migraine At 1521 patient reports nausea, vitals taken. Pulse 84, Blood pressure 178/108, oxygen 100% Laid pat... Read more
At 1521 patient reports nausea, vitals taken. Pulse 84, Blood pressure 178/108, oxygen 100% Laid patient down, water given, patient drank water, ice pack given, patient reports having migraine and has history of migraines. Patient continued feeling nauseous, patient laid down on cot. At 1538 patients vitals were reassessed blood pressure 184/98, oxygen saturation 99%, pulse 64. EMS called at 1541 due to patient reporting that had a foul taste in mouth and feeling a little pressure on throat, reported no difficulties swallowing, no salivating. Throat assessed moderate swollen left tonsil with white coating. Per patient she has had swollen tonsils for 2 days. Fire department arrived at 1608 vitals reassessed blood pressure at 152/98, pulse 63, oxygen 100%, respiration?s 17, denies shortness of breath. EMS at 1614 blood pressure 162/100, respirations 18, oxygen saturation 98%, pulse 64. Patient states feeling better and refused to go to hospital. EMS advised patient to take second dose of Benadryl if she feels the pressure again and seek immediate attention.
45 2021-04-23 migraine Migraine (severe throbbing headache, light sensitivity, nausea, vomiting) began approximately 7 days... Read more
Migraine (severe throbbing headache, light sensitivity, nausea, vomiting) began approximately 7 days after receiving my second dose and had mostly resolved by the end of that day.
45 2021-04-23 pain in extremity Flu like symptoms; Heat like rash across shoulder blades and upper back and down inside of right arm... Read more
Flu like symptoms; Heat like rash across shoulder blades and upper back and down inside of right arm; Itching; Left arm to hand pain felt extreme pain; Shot site sore; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982 and expiration date was not reported) on Left arm on 20Jan2021 at 02:30 PM at single dose for covid-19 immunization. Medical history included fibromyalgia, ADHD, bipolar type 2, anxiety, IBS, acid reflux. The patient's concomitant medications include lamotriginel, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate , omeprazole, clarithromycin, ascorbic acid. The patient was allergic to Loritab and Sulfa Meds. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 20Jan2021 at 03:00 PM, patient had shot site sore, nauseous. 25 min later left arm to hand pain felt extreme pain. Around 8pm itching and heat like rash across shoulder blades and upper back and down inside of right arm gone by morning. Next morning flu like symptoms until that Sunday. Patient took ibuprofen and Mucinex as a treatment medication. The outcome of the events was recovered.
45 2021-04-23 pain in extremity Still have lingering bone/joint pains and muscle aches down my legs from my hips flaring on and off ... Read more
Still have lingering bone/joint pains and muscle aches down my legs from my hips flaring on and off almost a month later. Hands too.
45 2021-04-24 electric shock sensation, feeling hot is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not d... Read more
is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not dizzy, she just feels like yuck; Patient states she has pain; she felt like she couldn't breathe; she felt like, not herself, like un-well. Patient states she is feeling unwell since; zapping, basically like a electric shock; nausea and vomiting; nausea and vomiting; extreme fatigue/that night she was exhausted, she couldn't pick up her head; head just doesn't feel right/she couldn't pick up her head; fever; closing of her throat; heat coursing through her body, felt heat in her vessels/she was a bloody, hot mess; chills; This is a spontaneous report from a contactable other health professional. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Patient states she had chronic strep throat, she was sick four times a year for the first 12 years of her life. Patient stated she has no allergies, she was a healthy woman. Concomitant medication included simvastatin taken for an unspecified indication from 2020 and ongoing. On 26Mar2021, the patient experienced nausea/vomiting happened almost immediately, soon after the injection. The patient stated she wasn't feeling well, she had to go home from work, but the symptoms started that day almost immediately and persisted for a few days later. She has this zapping. The patient stated it was actually a term, it's basically like an electric shock that she was feeling throughout her body, like from head to toe on 08Apr2021. The patient stated and her head just doesn't feel right, just like dizziness. The patient stated she has pain and was uncomfortable. Patient stated she was concerned about what to do moving forward. Patient stated the day she got the shot, within three minutes, she felt like she couldn't breathe. Patient stated it was not emotional, she's very self aware, she was a psychologist. Patient stated it was a closing of her throat, but that has turned on and off as well. Patient stated then she had heat coursing through her body, felt heat in her vessels, down the center of her throat down in to her throat into the center chest and down into legs. Patient stated that night she was exhausted, she couldn't pick up her head. Patient stated she threw up and had chills, she felt like, not herself, like un-well. Patient states she was feeling unwell since. Patient states she did travel that Monday after, which she doesn't know if it made it worse, but was gone only for an hour, then got sick again that night with fever and throwing up. Patient states then yesterday, she started getting these zaps in her body, it felt like someone had put a taser to her all over her body. Patient stated she was just not herself, she wasn't at her normal. Patient stated she passed out at 7PM at night. Patient verified she was not dizzy, she just felt like yuck. Patient stated she also experienced chills and fever, that happened later that day on 26Mar2021. Patient stated she came back to work and she just felt like she needed to go home. She was instantly not well. Patient stated she has had two antibody tests and she's been negative. Patient stated she checked after that, she made sure she had no antibodies. Patient clarified she checked her antibodies twice before getting the vaccine. Patient stated her resting heart rate was at 55, she was in athletic shape, she was healthy. Patient stated when she had the both, she was on the toilet and throwing up at the same time, she was a bloody, hot mess. Patient states she ripped her clothes off, she was hot. The outcome of the event nausea, vomiting, fatigue, "head just doesn't feel right" was recovered with sequel on 03Apr2021l; fever was recovered with sequel on 07Apr2021; chill was recovered on 03Apr2021; electric shock was not recovered and unknown for the other events. The patient did not received any recent vaccines for SARS-COV2 other than Pfizer- BioNtech COVID-19 Vaccine prior to the event being report and has not received any other vaccines around the time of Pfizer- BioNTech Vaccine Vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
45 2021-04-24 migraine Migraine that lasted for 27 hours. Migraine symptoms included severe headache with throbbing pain, n... Read more
Migraine that lasted for 27 hours. Migraine symptoms included severe headache with throbbing pain, nausea, sensitivity to light & sound & smell. Had to remain in bed for the full 27 hours.
45 2021-04-24 pain in extremity Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise... Read more
Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise. took IBU 800mg. CBC and CMP clinically unremarkable with no elevation of white blood cell count. HOWEVER, urine with 388 white cells/36 red cells/few bacteria and positive leukocyte esterase/nitrites. Chest x-ray without abnormalities. EKG showed sinus tachycardia at 108. No acute ST or T abnormalities. No ectopy. Renal ultrasound showed a non-obstructing stone in the kidney, but no hydronephrosis. COVID and Respiratory Panel were all negative. ER COURSE: Patient had already be given IV fluids/Tylenol/morphine prior to my evaluation and was feeling slightly better, but was still having generalized body aches and malaise... Blood cultures were drawn, and IV Rocephin was given. A second dose of morphine and Benadryl was needed to get the patient somewhat comfortable, but was still having severe body aches and malaise MEDICAL DECISION MAKING: Initial thought was adverse reaction to COVID vaccine, but patient also with significant UTI, febrile, and severe body pain requiring multiple doses of IV narcotics for control... Question of adverse reaction to vaccine and or UTI/early pyelonephritis or combination of both... Hospitalist was consulted to evaluate the patient... Will admit for observation status and continued IV medications. Date of hospitalization = 4/24/2021
45 2021-04-24 pain in extremity Fay of vaccine sore arm, headache. Three days later, felt like I was going to throw up and poop at t... Read more
Fay of vaccine sore arm, headache. Three days later, felt like I was going to throw up and poop at the same time. I was dizzy on the toilet, when I tried to leave the bathroom I fainted in the hallway. I had a racing heart and sweating. Then I began to have chills and pain inside my bones particularly my hips, legs and knees. Back pain too. Slight headache. This started at 9:30 pm 4/24/21, went to sleep, just nauseous. Middle of the night is when I woke up feeling like I was going to throw up and poop. I fainted at this time as well. In bed the rest of the night with pain in bones, tired, headache until about dinner time on 4/25/21.
45 2021-04-24 pain in extremity Sore arm for 2 days. Shingles virus 6 days after first dose.
45 2021-04-24 tingling, pain in extremity, flushing Generalized prickle sensation; Localized injection site urticaria; flushing; profuse sweating; arm p... Read more
Generalized prickle sensation; Localized injection site urticaria; flushing; profuse sweating; arm pain; loss of motion; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year female patient received BNT162B2 (lot number: EM9899) first dose on 17Dec2020 20:00 Intramuscular on right arm at single dose for COVID-19 immunization. Medical history included Asthma, Sulfa and Reglan allergies, Possible Covid 19 in Mar2020, Extensive cardia workup months following Dx with recurrent pericarditis, Non specific T wave abnormality on colchicinent Pepcid. Previous pericarditis Oct2016. Concomitant medications included Valsartan, amlodipine besilate, spironolactone, formoterol fumarate, mometasone furoate (DULERA), siugular, pristing, clonazepam, pramipexole dihydrochloride (MIRAPEX), Pepcid, colchicine (for pericardins). Patient had Flushing, Sweating (Perfuse sweating head and neck), Pain in arm and Mobility decreased (Moderate arm pain and loss of motion due to pain after both injections), Symptoms occurred 3-4 days after 1st vaccine and lasted 2.5 weeks. Organ involvement: Multiorgan Involvement, Respiratory, Bilateral wheeze/bronchospasm, Upper airway sweeling, Respiratory distress, Tachypnoea, Increased use of accessory respiratory muscles, Recession, Cyanosis, Grunting, Dry cough, Hoarse voice, Difficulty breathing (without wheeze or stridor), Sensation of throat closure, Sneezing, Rhinorrhea, Cardiovascular, Measured hypotension, Shock, Tachycardia, Capillary refill time > 3 sec, Reduced central pulse volume, Decreased level of consciousness, Loss of consciousness, Dermatological/Mucosal, Generalized Urticaria, Generalized erythema, Angioedema, Generalized pruritus with skin rash, Generalized pruritus without skin rash, Red and itchy eyes, Nausea, Vomiting, all were No. Generalized prickle sensation and Localized injection site urticaria were yes. The patient did not require medical intervention, the patient was not seen in the Emergency Department, not hospitalized, not admitted to an intensive care. The event did not require the initiation of new medication or other treatment or procedure. There is not a previous history of any allergies, does the patient take (or have readily available) any specific medication related to this. patient did not receive any recent vaccines for any other conditions prior to the event being reported, patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported, patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. None of the event above consideration serious due to begin life threating, or due to persistent or significant disability/incapacity or any other reason, if yes note below which event and serious criteria. patient not decreased. No treatment required. None of the AEs require a visit to: Physician office. No culture performed. No anti pyretic use. The outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.
45 2021-04-24 seizure Seizure
45 2021-04-24 tremor, pain in extremity Pain in arm a few days, then fatigue set in, then worse fatigue, then flu-like pain, for several day... Read more
Pain in arm a few days, then fatigue set in, then worse fatigue, then flu-like pain, for several days, then arms and legs felt heavy and lymph nodes painful everywhere all over my body, then shakiness, severe pain behind my neck/shoulders/back, legs feel like lead, arms lead, fuzzy feeling in my head because my arms and legs won't work properly, pain, just pain everywhere, fatigue and can't move. Mostly the pain is the worst part of it. Pulsating feeling in my lymph nodes and all over my body. It's been three weeks since vaccination and it's only gotten worse.
45 2021-04-25 pain in extremity "Hard, size of grapefruit, red, warm, itchy," and saw her doctor. He said it was not cellulitis. Pat... Read more
"Hard, size of grapefruit, red, warm, itchy," and saw her doctor. He said it was not cellulitis. Patient has an autoimmune disease and other conditions. Patient is better on 4/26/21 but still reports a sizeable, painful area on her arm.
45 2021-04-25 pain in extremity Sore arm, but adverse reaction was being lightheaded to the point I passed out for a few minutes. W... Read more
Sore arm, but adverse reaction was being lightheaded to the point I passed out for a few minutes. Within 20 minutes of waking and standing, I fell and passed out or passed out and fell.
45 2021-04-25 pain in extremity Severe headache, foggy feeling - strange. Excruciating pain at injection site - whole arm was so ver... Read more
Severe headache, foggy feeling - strange. Excruciating pain at injection site - whole arm was so very painful. Radiated into shoulder and neck, down arm. Headache is so bad.
45 2021-04-25 tingling, electric shock sensation Right hand fingers tingling, now feels numb, right foot tingling a day after my hand. The sensation ... Read more
Right hand fingers tingling, now feels numb, right foot tingling a day after my hand. The sensation to both is similar when it falls asleep and prickly. My right leg keeps having sharp type of shocking sensation first started on the bottom and now more towards calf. I can?t shake the tingling sensation in my right hand or my right foot and it?s been 3 days now.
45 2021-04-26 burning sensation Severe skin inflammation- burning, itching on entire body began 3-5 days after vaccine given
45 2021-04-26 muscle spasms, tremor, cold sweat, inability to speak, tingling, numbness, coordination abnormal Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness... Read more
Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness, heart pain, numbness and tingling in extremities, blurred vision, muscle spasms, poor muscle tone, rapid heart rate, drop in blood pressure, elevated heart pressure, trouble talking, brain fog, intestinal upset, cold sweats, tremor, poor coordination, restlessness, fatigue Onset at time of vaccine administration Labeled NOT anaphylaxis
45 2021-04-26 nerve pain 2 weeks after second Covid-19 vaccine, a severe shingles outbreak (confirmed by PCR) appeared on the... Read more
2 weeks after second Covid-19 vaccine, a severe shingles outbreak (confirmed by PCR) appeared on the left side of the scalp and face. The outbreak was causing severe nerve pain for 2 months, now managed with medication but still present.
45 2021-04-27 weakness, muscle twitching, muscle spasms I started to get muscle twitching in my left arm, it moved to my breast bone and around to the upper... Read more
I started to get muscle twitching in my left arm, it moved to my breast bone and around to the upper portion of my rib cage. I also experienced quite a bit of deep muscle pain around the injection site and extreme tiredness. I spoke to my doctor and he prescribed cyclobenzaprine for the twitching
45 2021-04-27 feeling hot The day of my second injection, I had soreness in my injection site. The following day, about 32 hou... Read more
The day of my second injection, I had soreness in my injection site. The following day, about 32 hours later, I felt warm, took my temperature, it was 99.9. I also had begun to have mid back pain that came on and intensified quickly. I had done nothing to cause an injury to my back prior to the pain starting. Over the next 1 1/2 days my pain traveled to my low back, the site of my lumbar fusion. The pain was extremely intense, reaching a 9-10 level. My sciatic nerve was effected and I had weakness in my right leg. I saw my family doctor the next morning. She prescribed pain medication and prednisone for 5 days. My symptoms began to alleviate within another day, but I am still having some residual effects. If the pain does not subside I will contact my surgeon for further investigation. The timing of my symptoms, and the lack of any activity that could?ve caused injury, seems too coincidental not to be a side effect of the vaccine.
45 2021-04-27 hypersensitivity of all senses Fever on and off for 48 hours, chills, headache, nausea, body aches, sensitivity to touch Symptoms ... Read more
Fever on and off for 48 hours, chills, headache, nausea, body aches, sensitivity to touch Symptoms still ongoing after 2 days
45 2021-04-27 numbness 4/28 Day 6 serious numbness in right leg, glute to heel, especially in calf and heel.
45 2021-04-27 pain in extremity Sore left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-... Read more
Sore left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:00 (Batch/Lot Number: EL3247) as single dose, dose 2 via an unspecified route of administration on 16Mar2021 10:45 (Batch/Lot Number: EL3247) as single dose for covid-19 immunization. Medical history included glucose tolerance impaired. Other medical history: pre-diabetes. There were no concomitant medications. On 23Feb201, the patient experienced sore left arm . She stated she had events on each of the day she got the shots. No other vaccine in four weeks and no other medications in two weeks was given to patient. The patient was not priorly vaccinated for covid. The patient was not covid tested post vaccination. The patient had no known allergies. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
45 2021-04-27 pain in extremity Sore arm at injection site and runs to the back of the arm. Pain pulses at injection site. Pain radi... Read more
Sore arm at injection site and runs to the back of the arm. Pain pulses at injection site. Pain radiates down left arm into hand. Pain is worse above my wrist - between elbow and wrist and back of arm. Random pain shoots from injection site down arm. It only lasts for a second or two but it is intense. I have not taken any pain relievers yet.
45 2021-04-27 seizure On cell phone at approximately 1120AM in monitoring area; per volunteer MD and volunteer RN, pt voic... Read more
On cell phone at approximately 1120AM in monitoring area; per volunteer MD and volunteer RN, pt voice louder, was observed leaning forward in chair. Pt stated not feeling well and noted to have moist pale skin. Assisted to floor at approx. 1123, feet elevated. Pt had full body seizure with oral secretions at approximately 1125; O2 applied, airway/limbs and head were protected. VS at 1125 160/100, HR 93, O2 sat 99%. EMS called at 1127, pt seizure approx. 1 minute. Pt aroused, oriented to name, place, requested mom be called. Mom called at, she denied seizure hx. Pt VS monitored at 1130 99% sat, 96 HR, 160/115, EMS arrived at 1135 sat 99%, HR 81, transported to ED with EMS.
45 2021-04-27 tremor I started my period the day after the vaccine, midway through my normal and very regular cycle. My p... Read more
I started my period the day after the vaccine, midway through my normal and very regular cycle. My period was early after the first shot, too, and longer and heavier than normal. I also had normal side effects starting 10 hours after injection and lasting for about 30 hours; fever, chills, shaking, fatigue, nausea, muscle, and joint aches.
45 2021-04-28 weakness light headed, dizziness, weakness
45 2021-04-28 facial paralysis, bell's palsy, nerve pain, weakness On Monday April 12th I woke in the morning not feeling myself, I noticed that i had no feelimh on th... Read more
On Monday April 12th I woke in the morning not feeling myself, I noticed that i had no feelimh on the right side of my face and no control on the left side of my face I went to the hospital because I wanted to be sure thatI was not suffering from a stroke. they ran testes. it was con firmed that i did suffer a stroke, but i was in fact suffering from Bells Palsy. Now I have never had Bells PAlsy in my life and was made aware that this could happen out of no where but hey also indicated if i had done anything out of the ordinary. In that case I was still within my five day window of receiving my 1st Pfizer vaccine.
45 2021-04-28 flushing Sudden face flushing with elevated blood pressure and HR. Gave 50mg diphenhydramine capsule by mout... Read more
Sudden face flushing with elevated blood pressure and HR. Gave 50mg diphenhydramine capsule by mouth. Initial vital signs at 2:20pm. BP: 155/102, HR: 87, RR: 24, Pulse ox: 98% on room air. Discharge vitas signs at 2:40: BP: 120/92, HR: 72, RR: 16, Pulse Ox: 97% on room air. All complaints resolved, flushing resolved, no other symptoms.
45 2021-04-28 numbness patient reports lightheadedness,chest tightness and SOB, left leg numbness, no rash or soreness. she... Read more
patient reports lightheadedness,chest tightness and SOB, left leg numbness, no rash or soreness. she reported the history of anxiety,asthma,stroke, she is diaphatic and had sewlling on injection site. vital signs; BP 137/100, HR92, TEMP 97.5, unable to take pulse. patient was transfered to medical tent for 1hr. vital signs were : BP 140/82,HR80,TEMP 98.2,RR18 Patient was offered futher tx at the emergency dept, she declined
45 2021-04-28 migraine I had a mild headache on the day of the vaccine and for the following two days after. On day 3, I d... Read more
I had a mild headache on the day of the vaccine and for the following two days after. On day 3, I developed a severe migraine headache that lasted for 5 days. At times, the pain was so intense that it woke me from my sleep and it was difficult to hold my head up. I saw my doctor for the headache on day 3 of the migraine who determined I did not need emergency care but should consult a neurologist and seek an MRI with contrast. I will be making these appointments in the near future. I attempted to treat the migraine with ibuprofen as directed by my doctor but it did not relieve the symptoms. I have never experienced a headache that lasted this long or of this type of intensity in my life. Total time the headache lasted was 8 days. And I am still experiencing mild head pain now.
45 2021-04-28 pain in extremity, feeling hot As described by the patient: As they were putting the vaccine, the area got really warm, and the ar... Read more
As described by the patient: As they were putting the vaccine, the area got really warm, and the arm began to feel inflated. Then I began to feel the liquid moving through my arm, elbow, and wrist. My wrist started hurting. I told the nurse, who told me to keep moving the arm. As time passed (15 minutes), the warm feeling flowed to my should and left side of my back. Another 15 min passed, and it moved down my left leg and knee, which started to hurt. Then got neck got warm and stiff, and I felt the warm feeling got to the left side of my brain. 15 minutes passed left side of the face got warm. And then it headed to my lips and then tongue. Lips got numb, and tongue got numb. 5 minutes pass and my tongue and
45 2021-04-28 tingling Right leg paresthesias
45 2021-04-28 seizure, burning sensation, feeling hot, myelitis transverse, tingling Approximately 5-6 days after my second Pfizer vaccine dose, I began having paresthesias in patchy ar... Read more
Approximately 5-6 days after my second Pfizer vaccine dose, I began having paresthesias in patchy areas on the outside of my right ankle. Over the next 3-4 weeks, the paresthesias (burning, tingling, temperature sensation) progressed to the other leg and then ascended up the legs bilaterally to the upper thigh area. I consulted my neurologist and he ordered a MRI of the cervical and thoracic spine. The day after the MRI (4/15/21), I had two seizures in the morning after being seizure free for a year. I had significant fatigue and felt very poorly. A few hours later, I had a sudden onset of severe bilateral leg weakness. Because I could not walk, EMS was called. I went to Hospital where I was admitted for leg weakness. Additional imaging was performed. I was able to walk a few steps after receiving a dose of 1g solumedrol via IV that night. My symptoms improved over the next few days with IV steroid treatment. I was discharged on 4/19/21 and was advised to follow up with outpatient neurology. My neurologist initially diagnosed acute transverse myelitis and ordered physical therapy. I continued a steroid taper for 6 days after hospital discharge. Today (4/29/21), my symptoms have improved but continue to have adverse effects. I am able to walk but tire quickly and am very fatigued. I have been unable to work since hospital discharge.
45 2021-04-28 tenderness Swelling, Tenderness, Redness that continues to spread up and around arm 2 days after vaccine.
45 2021-04-29 breast pain, feeling cold I got my second Pfizer COVID-19 vaccination on April 13; had no symptoms beyond a sore arm with the ... Read more
I got my second Pfizer COVID-19 vaccination on April 13; had no symptoms beyond a sore arm with the first. About a week after the second dose, I began experiencing a lot of pain/irritation/itchiness along the side of my right breast, under my right arm, and around to my right shoulder blade/upper back. (I thought it was just dry skin or some random irritation ? but the skin looked completely normal.) The skin irritation/pain/itchiness lasted for four days, and on the fifth day (Sunday, April 25) I began developing a rash where the pain was. I was diagnosed with shingles by my doctor on April 26 (via a telehealth appointment, I emailed pictures) and had an in-person follow-up on Tuesday, April 27, with another doctor at the same practice (mine was out of office that day but wanted me to come in asap). Shingles was confirmed and I was given some fun prescriptions. It is April 30 now; I am taking valacyclov (1 gram tablets) 3x per day; I give occasional stink-eye to the bottle of gabapentin I was given... not taking it; I'm sticking with Motrin for pain. I have had some intermittent chills here and there, low-grade fever (mostly in the evening, but it's probably because I'm still working during the day from home and I'm just extra run-down). The rash is pretty gross and angry-looking at this point, honestly. It's started blistering and running its course, which kinda sucks since it's underneath my entire right breast, beneath my arm (not IN my arm pit, but a couple inches below) and my right shoulder blade and now a patch in my mid-upper-back. Needless to say, I'm living my best life in a soft t-shirt with no bra. (Working from home for the win!)
45 2021-04-29 feeling hot, feeling of insects crawling on skin Within seconds/ less than a minute of receiving the vaccine, I felt heat rush up through left side o... Read more
Within seconds/ less than a minute of receiving the vaccine, I felt heat rush up through left side of neck... Then underneath my eye / crawl / felt strange like swelling. Then within 5-10 min my skin on left side of head crawl .... But ok within an hour. Only on left side. Also, no pain at all didn't even feel needle go in but had lump at injection site and painful when touched until Day 12.
45 2021-04-29 pain in extremity Little bit of a sore arm the day of and the day after. But the third day i had a very swollen lymph ... Read more
Little bit of a sore arm the day of and the day after. But the third day i had a very swollen lymph node in my right arm pit.
45 2021-04-29 pain in extremity During the night, I had a really strong headache, nausea, chills, pain in my left arm that reached m... Read more
During the night, I had a really strong headache, nausea, chills, pain in my left arm that reached my chest, and then a lot of sweating. Wednesday I did not work, Thursday I still worked with the pains. Friday I woke up around 5:00 am with severe chest pain and nausea. The pain was not normal, I went to the Hospital, to the emergency room.
45 2021-04-29 tingling, pain in extremity Pt presents today to talk about side effects from COVID vaccine. States she recieved 1st pfizer vacc... Read more
Pt presents today to talk about side effects from COVID vaccine. States she recieved 1st pfizer vaccine 03/02/21 in R arm. States the next day she had hives on her R thigh for about an hour and went away. The following days she complains of flu like symptoms, extreme fatigue, arm and leg weakness. States she has been talking to her nutritionist who told her immune system is very low from vaccine and gave her a supplement (Immuplex). States symptoms persisted, "prickly cough, sore neck and back" was tested for COVID on 03/19/21 (negative). states she started to feel better for a day. Arms and legs were painful but not weak. Weakness ended up returning. April 26th and 27th she states she couldn't walk or move her arms. Did not go to ER. Spoke to nutritionist who stated her heart was low functioning and gave her some more supplements. Pt today still complains of weakness in arms and legs and a "pins and needles sensation". Current list of supplements patient is using from Dr include Immuplex, CoQ-10, Drenamin, Hawthorn, Lact-Enz, Cardiotrophin
45 2021-04-29 tingling Patient experienced perioral tingling and swelling after dose #1. Experiencing tingling few minutes ... Read more
Patient experienced perioral tingling and swelling after dose #1. Experiencing tingling few minutes After administration of dose # 2 today. Benadryl 25mg PO administered. Monitored for 15 minutes. Denies any trouble swallowing, SOB, or swelling. Patient was discharged home
45 2021-04-29 tingling Blood in urine, vertigo, pins and needles on legs. Blood in urine visible on urine for 2 days and no... Read more
Blood in urine, vertigo, pins and needles on legs. Blood in urine visible on urine for 2 days and no longer visible but still on microscopic test. Vertigo stopped lasted for 5 days. Pins and needles on legs still present on day 10 after vaccination
45 2021-04-30 feeling cold Joint aches about 9 hours post vaccine, vomiting at 10 hours (possibly motion induced), fever/chills... Read more
Joint aches about 9 hours post vaccine, vomiting at 10 hours (possibly motion induced), fever/chills/general flu like symptoms from 14 to 26 hours post vaccination
45 2021-04-30 flushing Patient given first dose of COVID vaccine today. Patient was well after vaccine and when walking out... Read more
Patient given first dose of COVID vaccine today. Patient was well after vaccine and when walking out she felt dizzy. She sat down at a nearby bench. She had no LOC. She has no PMH, no medications. On exam BP 120/80, RR 16, HR 100 Oxygen 98%, Exam Patient appeared flushed and sweaty, she was alert and oriented, Heart: RRR, S1 and S2 normal, no murmur, Lung: clear bilaterally. Patient was given water and a snack. She had not eaten breakfast this morning. Patient also said she felt nervous about getting the vaccine. Patient monitored, patient improved. Patient went home with family that was here to get vaccinated as well.
45 2021-04-30 pain in extremity, numbness and pain in extremities Arm weakness/leg weakness; Little irritation at the injection site; Minor headache off and on; Leg p... Read more
Arm weakness/leg weakness; Little irritation at the injection site; Minor headache off and on; Leg pain/really bad arm pain in the left arm with lifting and movement/arm pain; Itching on chest and arms; Tenderness in injection site; Neuropathy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955; Expiration date was not reported) on the left arm on 27Mar2021 (19:55) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital (not a military facility). The patient had no relevant medical history. Concomitant medications included cetirizine hydrochloride (ZYRTEC). On an unspecified date in 2021, the patient had neuropathy. On 27Mar2021, the patient had minor headache that was off and on; leg pain and really bad arm pain (left arm) with lifting and movement; itching on the chest and arms; and a little irritation at the injection site. On 28Mar2021, the patient had arm and leg weakness. In Mar2021, the patient had tenderness at the injection site. The patient had received diphenhydramine (BENADRYL) as treatment for the itching on the chest and arms. The patient's x-ray was normal on an unspecified date in 2021. The outcome of the events was not recovered for 'arm and leg weakness'; recovered on 27Mar2021 for 'itching on the chest and arms'; and was unknown for all the other events. The patient was scheduled to receive the second dose of vaccination, but did not want to risk having the same effects in the right arm.
45 2021-04-30 pain in extremity I had a sore arm and brain fog (really couldn?t think effectively for 4 days after my vaccine.)
45 2021-04-30 pain in extremity Pain on left foot - feels like a small bump; Pain on left foot - feels like a small bump; This is a ... Read more
Pain on left foot - feels like a small bump; Pain on left foot - feels like a small bump; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced pain on left foot - feels like a small bump on 31Mar2021. The event was reported as non-serious. The patient did not receive any treatment as a result of the event. The clinical outcome of pain on left foot - feels like a small bump was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-04-30 tingling Left arm from shoulder down through tips of fingers feels like 1,000 little pin pricks of electricit... Read more
Left arm from shoulder down through tips of fingers feels like 1,000 little pin pricks of electricity. I have a weakened grip also. It started within 30 minutes of getting the vaccine and has not let up at all. If I stretch my arm above my head, the feeling is stronger and sharper (the electrical pin pricks). Other symptoms are the same as the first vaccine injection I received (April 8, 2021 Pfizer lot #ER8727) which were and are nausea and tiredness.
45 2021-04-30 seizure, pain in extremity it could have been a seizure; Unconscious/Collapsed/ diagnosed her as having a Syncopal Episode; Uri... Read more
it could have been a seizure; Unconscious/Collapsed/ diagnosed her as having a Syncopal Episode; Urinated on self/Wet her pants; Headaches; Feeling light headed; Felt her heart beat faster; Sore arm; This is a spontaneous report from a contactable nurse (patient mother). A 45-year-old female patient received bnt162b2 (BNT162B2, lot number EW0150 and expiration date was not provided), via an unspecified route of administration first dose on 05Apr2021 15:00 at single dose for covid-19 immunisation. The patient's medical history included ongoing Hypertension (Patient diagnosed in her late 30's), ongoing Hypothyroid (Patient diagnosed when she was around 20 years old), ongoing Allergies, ongoing Gastrooesophageal reflux disease (The patient was exposed to a chemical in her 20's that caused this condition), ongoing Birth control, ongoing Allergic to eggs (States patient has never received the flu vaccine due to her egg allergy), and ongoing Allergic to shellfish. The patient's concomitant medications included ongoing levothyroxine at 150 ug, 1x/day for Hypothyroid, ongoing Hydrochlorothiazide at 12.5 mg, 1x/day for hypertension, ongoing omeprazole at 20 mg, 1x/day for gastrooesophageal reflux disease, ongoing losartan at 100 mg, 1x/day for hypertension, ongoing norethisterone (SHAROBEL) for Birth control. On 06Apr2021 13:00, the reporter stated that her daughter fainted at work, lost her urine, and was unconscious and was taken to the Emergency Room. Primary Care Physician told her daughter she should have no problem getting the second vaccine. States that she was not certain if her daughter should get the second shot. It was scheduled for next week. Also, reported that after lunch reporter stated that her daughter fainted in her office at work. She had urinated on herself and was unconscious. Caller was concerned it could have been a seizure. Her daughter was taken to the Emergency Room and they diagnosed her as having a Syncopal Episode. On 06Apr2021, the patient had headaches that continue since these events. The reporter stated that her daughter's doctor told her daughter that the blood work and electrocardiogram done at the Emergency Room were normal. The Emergency Room and her daughter's doctor acted like her symptoms were not serious. The reporter looked at the Vaccine Adverse Event Reporting System website and it said that a syncopal episode is a reportable event. Says that her daughter's doctors did not report this event. Says doctors need to have training on the importance of reporting events. The reporter called the Food and Drug Administration last week but she hasn't heard anything from them. States they told her it could take 5-7 business days. Says she called Pfizer today to see if there was any further information or guidance she could get as she is concerned about her daughter. She says her daughter has her own office so she was in there alone when she collapsed. Someone found her on the floor. The reporter was asking for guidance on administration of the second vaccine dose following a syncopal episode after the first. The patient received her first vaccine dose on 05Apr2021 15:00 and she was fine, she had a sore arm, but went to work the next day (06Apr2021) and after lunch she reported feeling light headed and felt her heart beat faster and went to get up and a colleague later found her on the floor and she had wet her pants. They took her to the ER around 1 pm the day after her vaccination and diagnosed her with a syncopal episode stating that they didn't think it was from the shot. The events syncope, urinary incontinence, seizure, and headache were considered as serious (medically significant) by the reporter. The events syncope, and urinary incontinence caused emergency room visit and physician office visit. The outcome of the events syncope, urinary incontinence was recovered on 06Apr2021. The outcome of the event Headache was not recovered. The outcome of the remaining events was unknown.; Sender's Comments: Based on the information currently available, a causal association between the reported events and bnt162b2 cannot be fully excluded.Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
45 2021-05-01 weakness, feeling hot After 2nd COVID shot on Tuesday, April 27th at 11:30 am about 6-8 hrs later I became very weak and t... Read more
After 2nd COVID shot on Tuesday, April 27th at 11:30 am about 6-8 hrs later I became very weak and that evening started with expected fatigue, 100.8 fever, bone and muscle aches in extremities, severe headache in nape of neck, little ability to sleep, no appetite, hot and cold chills until Thursday morning at 6:30am I awoke with severe headache in forehead and loud ringing in both ears. This ringing has continued for 4 days and gotten worse with pain and pressure deep in my ears, forehead headache, and altered hearing when I bend forward or chew food. This has greatly affected my daily activities. I?m very worried about my hearing. I?m scared about the ringing as it is distressing and I have not experienced this before. The fever broke Thurs. am (I was very sweaty) and chills, fatigue, weakness subsided but Ear pain, ringing has gotten worse. I contacted Dr. by app text communication within 2 hours of the ear ringing on Thursday morning at 8 am and she said symptoms can last a week and that I could take Tylenol and ibuprofen. I did not take Tylenol or ibuprofen until Thursday and have taken 2 times daily since but this has not helped my headache, ear pain, or ringing. I did not take any Medication Tuesday or Wednesday for fever and vaccine side effects because I saw on news and read that you should let immune system and vaccine work. I had only a sore arm for 24 hrs with first shot. I am normal BMI, normal weight, hypothyroidism, no alcohol, no smoking, no drugs, moderate activity.
45 2021-05-01 numbness 1-st day hand numb and dizzy at the end of the day. I had to take aspirin which only decreased the ... Read more
1-st day hand numb and dizzy at the end of the day. I had to take aspirin which only decreased the symptoms The next three-five days so dizzy that I was nausaed and threw up. First two days I had trouble holding down food because I was dizzy and nauseated. By Friday at time my heart felt like it was racing but when I checked my heart rate was normal. I also felt hot and upper chest muscles to the left hurt. By Saturday evening I felt really sick. My heart felt like it was racing but when I checked it was normal. I then checked my blood pressure it was 120 and it is never high. I then two hours later and it was 108 and checked an hour later it was 102. I didn't that if it fell under 100 I would go to the hospital but it didn't. On Monday, I was still vomiting and trying to get through my Zoom class. I refused to go to the hospital because I am afraid to catch COVID there. By the end of the week, I was feeling better but still slightly dizzy and nauseous. When I took the second vaccine, my symptoms were not as severe as after the first shot. I was still dizzy and nauseous but not so sick to vomit or to stay in bed all day. I still felt my heart racing but this time I didn't check my blood pressure. Also after the second vaccine. the symptoms didn't last as long (not more than seven days).
45 2021-05-02 weakness Fever. Extreme all over muscle pain and soreness. Debilitating. Could not move or get out of bed for... Read more
Fever. Extreme all over muscle pain and soreness. Debilitating. Could not move or get out of bed for 24 hours. Headache still lingering.
45 2021-05-02 discomfort About 16 hours after 2nd Dose of Pfizer COVID-19 vaccine, patient developed swelling, extreme discom... Read more
About 16 hours after 2nd Dose of Pfizer COVID-19 vaccine, patient developed swelling, extreme discomfort, and partial loss of motion in left arm where injection was administered. Vaccine appears to have aggravated local inflammation from a pre-existing clavicle dislocation. Original clavicle dislocation possibly coincidental with Pzizer first dose (lot EP7533) in same arm.
45 2021-05-02 pain in extremity, burning sensation, tingling Burning and tingling down arm right away. 7 hours later back ache, arm pain, burned when I touched i... Read more
Burning and tingling down arm right away. 7 hours later back ache, arm pain, burned when I touched it, 24-60 hours later burning scalp on opposite side of injection, severe back pain, burning in left shin. 2 weeks after back pain still, severe hand joint pain. 3 weeks later severe knee joint pain swollen lymph nodes on right side on and off still.
45 2021-05-02 pain in extremity Upper arm and shoulder has been consistently aching and in pain.
45 2021-05-03 feeling hot Lightheadedness, over heating
45 2021-05-03 migraine severe migraine, eyes swollen shut, lips swollen, throat felt tight, swollen, sudden jolts of pain i... Read more
severe migraine, eyes swollen shut, lips swollen, throat felt tight, swollen, sudden jolts of pain in head, dizziness, since the 17th, day after the vaccine.
45 2021-05-04 weakness On 4/23/21 I felt run-down, achey, and had a low-grade fever that did not register. Late in the day ... Read more
On 4/23/21 I felt run-down, achey, and had a low-grade fever that did not register. Late in the day I started developing a rash similar to what I experienced after dose #1 on forearms, area between shoulders and chest, and a little on the neck. On 4/24/21 the rash had spread on my neck and on my toes of both feet. It hurt for me to put pressure on my toes with just normal walking. This lasted around 36 hours. The rash did not fully subside until 48-56 hours. The injection site on my left arm was hot for around 4-5 days.
45 2021-05-04 feeling hot Client stated a rush of dizziness overcome her as well as feeling hot.
45 2021-05-04 hot flush, weakness Shortly after shot my index finger (same arm shot was in) started to bruise around the bottom, start... Read more
Shortly after shot my index finger (same arm shot was in) started to bruise around the bottom, started to swell, and was warm to the touch. This continued for about 3 days which is about the same course of time I had the normal symptoms. Could barely function with headache, body aches, extreme weakness and fatigue. extreme nausea and stomach pains. Sweating and hot and cold flashes. Since then I?ve also had random fevers with extreme hot checks. Twice last week once the week prior. These were very random. The finger was very odd and was instructed to report.
45 2021-05-04 numbness, bell's palsy Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on ha... Read more
Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on hands, trunk and head: itching; itching; facial swelling/ swelling in face; hand swelling/ swelling in hands; tingling in lips; some mild difficulty swallowing; throat swelling; mild difficulty breathing; numbness; swelling in mouth; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 06Apr2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 05Feb2021 15:00 (lot: EN6201) and second dose on 25Feb2021 15:00 (lot: EN6205); both via an unspecified route of administration in left arm (at the age of 45-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient have not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included known allergies Sulfa, bee stings, shellfish and Ceclor. Concomitant medications included armodafinil; clonazepam; vortioxetine hydrobromide (TRINTELLIX), also Tooo Max and an unspecified vit. The patient experienced Bells Palsy on right side of face; throat swelling; itching; mild difficulty breathing; severe rash on hands, trunk, neck; numbness; swelling in mouth; large blister like bumps on hands, trunk and head: itching; facial swelling/ swelling in face; hand swelling/swelling in hands; tingling in lips; some mild difficulty swallowing on 02Mar2021 at 15:00. The patient considered the case as non-serious, did not result in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and non-congenital anomaly/birth defect. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received prednisone, cetirizine hydrochloride (ZYRTEC), omeprazole (PRILOSEC), methylprednisolone sodium succinate (SOLU-MEDRO) IV at ER as treatment. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-05-04 numbness, depressed level of consciousness Rapid heart rate of 120 - 160 BPM (while sitting down) for over an hour. Difficulty remaining consc... Read more
Rapid heart rate of 120 - 160 BPM (while sitting down) for over an hour. Difficulty remaining conscious and numbness in my face.
45 2021-05-04 pain in extremity Arm pain; nausea; dizziness; aches; fever; This is a spontaneous report from a contactable nurse. A ... Read more
Arm pain; nausea; dizziness; aches; fever; This is a spontaneous report from a contactable nurse. A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in right arm on 20Jan2021 17:30 (at the age of 45-year-old, Non-pregnant) (Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included migraine, essential tremor, fibromyalgia, arthritis and allergic to Sulfa. Patient has not covid-19. Concomitant medications included methylphenidate hydrochloride (CONCERTA), Propranolol, Tizanidine and Trazodone all for unknown indication. The patient experienced arm pain, nausea, dizziness, aches and fever on 21Jan2021 13:00. Since the vaccination, the patient not been tested for COVID-19. No treatment for events.Outcome of the events was recovered on an unknown date in 2021. Follow-up attempts are completed. No further information is expected.
45 2021-05-04 pain in extremity Chills; Fever; Body aches; Sore arm; Diarrhea; This is a spontaneous report from a contactable consu... Read more
Chills; Fever; Body aches; Sore arm; Diarrhea; This is a spontaneous report from a contactable consumer(patient). A 45-year-old female patient (not pregnant) received 2nd doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single doe on 16Apr2021 15:00 via an unknown route in left arm for Covid-19 immunization. Medical history included obesity, allergies, eczema and allergy with penicillin. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 03:00 PM in left arm for Covid-19 immunization. No other vaccine received in four weeks prior to the COVID vaccine. It was unknown if other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 17Apr2021 01:00, patient experienced Chills, Fever, Body aches, Sore arm, and Diarrhea. No treatment received. The report was reported as not serious. Outcome of the events was resolved. Serious: No On 17Apr2021 : 01:00 AM, patient experienced adverse events of Chills, Fever, Body aches, sore arm, Diarrhea. No treatment received. Outcome of the events was resolved. No covid tested post vaccination. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-05-05 burning sensation, weakness From the date of the injection, May 1, 2021 until Wednesday, May 5, 2021 (total of 5 days), I had ex... Read more
From the date of the injection, May 1, 2021 until Wednesday, May 5, 2021 (total of 5 days), I had experienced all of the following, (not always happening at the same time): Headache, fever anywhere from 101 to 104, severe chills that were painful, all over body aches that can only be described as a feeling of my nerve endings being on fire, nausea, muscle pain that made it difficult to walk, diarrhea, feeling of weakness and exhaustion.
45 2021-05-05 flushing, tingling Within minutes, my fingers felt prickly, then flushing of face, neck and chest; a prickly heat. Con... Read more
Within minutes, my fingers felt prickly, then flushing of face, neck and chest; a prickly heat. Continued redness and slight itchiness on neck hours after onset. No fever. I?m reporting this while it is still an ongoing event
45 2021-05-05 pain in extremity Pt reports that with her 1st dose she experienced mild lips tingling sensation approx. 30 minutes po... Read more
Pt reports that with her 1st dose she experienced mild lips tingling sensation approx. 30 minutes post-vaccination and a very mild metallic taste, symptoms subsided couple of hours later same day. With 2nd dose metallic taste is mild, and lips tingling sensations is non-continuous. Pt also reports that the her existing lower back pain seems to increased a little as well. Tylenol 2 tablets same day of vaccination for both doses for sore arm, pt states did not help. Pt also reported that she took Tylenol before going to get her 2nd dose to avoid ADEs. Recommend pt to stay hyrated and could try loengez for to see if it will help with the metallic taste. If symptoms does not get better in a few days to contact MD. Pt reports that she woke up at ~0300 or 0400 5/3/2021 with a fever 102 F, headache, pain in her lower back doubled in intensity, and her whole body was achy and in pain. Pt reports she took 1,000 mg of Tylenol at 1000 this morning and that helped with the fever and headache. Pt also reports that since her lower back was hurting so much she took a hot shower and massaged the methanol and epsom salt body soak on areas of her body that was achy and in pain, and she reports that all her symptoms subsided last night at 1800 hours after she woke up from her sleep and she feels more energetic. Today she is back to normal and reports having way more energy. **NOTE** Advised pt to be careful with the way she is using the body soak to prevent possible skin irritation since is made to be soak. Pt advised she does not do this often, she was desperate and it helped with her aches and pain.
45 2021-05-05 pain in extremity Severe headache, chills, nausea, sore arm from wrist all the way to base of skull on left side. Swo... Read more
Severe headache, chills, nausea, sore arm from wrist all the way to base of skull on left side. Swollen and very sore lymph nodes in armpit.
45 2021-05-05 pain in extremity Patient reschedule second dose scheduled for April 22nd and shared via email communication with vacc... Read more
Patient reschedule second dose scheduled for April 22nd and shared via email communication with vaccine clinic that she cancelled her appointment as she was feeling unwell and was diagnosed with shingles. She stated "there was no rash, but extreme pain in the left side of my body. The pain began in my left arm, about ten days after receiving the first dose of the vaccine. It may have been just a coincidence, but I was very concerned about getting the second dose. " The patient is planning to proceed with receiving her second dose
45 2021-05-05 pain in extremity Immediate chest pain (tightening) , then arm pain while in store/pharmacy Next Day began spotting (m... Read more
Immediate chest pain (tightening) , then arm pain while in store/pharmacy Next Day began spotting (menstrual bleeding) and lasted for 2.5 days Chest pain continued and has not stopped for last 10 days, intermittent throughout the day - tigheting of left side and right side of chest, radiates to theback Sunday following Monday vaccination (6 days later) got a blood clot on palm of hand, lasted for 4 days that started bleeding out and blood spread to front of hand like a birthmark as it bleed out
45 2021-05-06 weakness WEAKNESS, DIZZINESS, HEADACHE, NO SYNCOPE, NOT EATEN SINCE 5PM DAY BEFORE, CODE GREEN CALLED. SX RE... Read more
WEAKNESS, DIZZINESS, HEADACHE, NO SYNCOPE, NOT EATEN SINCE 5PM DAY BEFORE, CODE GREEN CALLED. SX RESOLVED, REFUSED TRANSPORT.
45 2021-05-06 feeling hot I felt a slight fever and chills last night, nausea and passed out this morning (5am). Headache, nau... Read more
I felt a slight fever and chills last night, nausea and passed out this morning (5am). Headache, nauseous and still warm now (9:58 am). Very achy.
45 2021-05-06 numbness, pain in extremity, tingling Tingling " like novocaine at the dentist" on one side of face. Itching at same sight. Tounge itching... Read more
Tingling " like novocaine at the dentist" on one side of face. Itching at same sight. Tounge itching as well though never experienced that before in life. Lasted 25 min. Numbish cheek lasted for a day. Arm pain severe and lost ability to lift it for days. In good health and strong normally.
45 2021-05-06 numbness, tremor All Covid symptoms returned. Tremors. Severe headache. Numbness in right side of face and body. Dizz... Read more
All Covid symptoms returned. Tremors. Severe headache. Numbness in right side of face and body. Dizzy. New was throat swell and tongue swelling.
45 2021-05-06 pain in extremity Pretty intense full body pain 12 hours after injection. Pain sites included: neck, shoulder blades,... Read more
Pretty intense full body pain 12 hours after injection. Pain sites included: neck, shoulder blades, clavicles, hips, lower back, knees ankles, bottom of feet, headaches, wrists, calves, thighs, buttocks. The pain was pretty much constant, rotating intensity between sites. Definitely be described as pain and not body aches. Sometimes reaching a 7 on the pain scale. I am still experiencing random spots of pain on 5/7/21 at 4:00 pm.
45 2021-05-07 feeling hot Very anxious about receiving second vaccination, expressed anxiety during vaccination. Approximatel... Read more
Very anxious about receiving second vaccination, expressed anxiety during vaccination. Approximately 10 minutes after vaccine given at 11:05, c/o feeling ?warm all over?. Relevant history ? had onset of severe HA within 3 hours of first vaccine that lasted 2 days ? treated self at home with ibuprofen for same. T2DM, takes insulin and metformin, took meds today, ate 1 hotdog only for breakfast. Has not checked blood sugar today. Remote migraine history, last treated for same 8 years ago. Primary 11:18: P 103, R 20, SpO2 99%. c/o feeling ?warm all over?, skin warm, dry, pale. No rashes or hives. No dyspnea or respiratory distress. Lungs clear. Declined to lie down. 11:20: BP 117/84, P 100, R 20, SpO2 99%. c/o onset bilateral frontal HA ? this HA feels same as HA after 1st Covid vaccine. No other neurologic sxs, no dizziness, nausea. Alert, oriented, no speech or motor deficits. No respiratory distress, no rash/hives. Taking a few sips of juice. 11:22: c/o ?head feels really hot? 11:25: BP 118/84, P 95, R 16, SpO2 98%. Alert and oriented, sitting up, eating a crackers and juice. Skin warm, dry, no longer pale. 11:30: HA remains, focused in frontal area and behind both eyes, again describes as like HA following first Covid vaccine, though ?not as bad?. 11:35: HA remains, but feels enough better that she wants to go home. 11:39: Husband present with patient. Advised both that she should FU after leaving vaccination clinic with her healthcare provider today re: HA. Referred to the after-hours clinic for further evaluation today. 11:46: HA remains, no change in mental status or neurologic condition. Discharged home with husband in stable condition. Provided with address, phone, and directions to Urgent Care Center. Declined wheelchair to vehicle, walked to POV, escorted by RN.
45 2021-05-07 numbness Slow on set of another possible bout of myelitis. Numbness, dizziness, headaches.
45 2021-05-07 tenderness, pain in extremity Woke up at 2.30 am after getting the first dose and felt nauseous, and had fever chills and a headac... Read more
Woke up at 2.30 am after getting the first dose and felt nauseous, and had fever chills and a headache and slightly disoriented. Was unable to sleep until after 5 am. Woke up around 10.30 am with a bad headache that stayed for several hours. Also tenderness, pain and redness in the arm that received the shot for 2-3 days.
45 2021-05-08 pain in extremity First dose I have a very sore arm 3 weeks still. Second dose I have a high fever, chills, headache, ... Read more
First dose I have a very sore arm 3 weeks still. Second dose I have a high fever, chills, headache, body ache, sore arm, nausea, joint pain
45 2021-05-09 weakness Experienced fever of 104.2; 103.5; 101.3 with headaches and weakness.
45 2021-05-09 nerve pain, weakness Within minutes, I experienced tachycardia and syncope with weakness. After 30+ minutes, they clear... Read more
Within minutes, I experienced tachycardia and syncope with weakness. After 30+ minutes, they cleared me to go home with no intervention. My heart rate had come down and though still weak they felt I was ok. Hives began within this period and worsened after my release. Nausea and dizziness within the hour which persisted for 5 days with fevers, chills and sweats, until diarrhea became the predominant stomach ache. Through the first three days, chest pain and weakness continued with the dizziness, fevers and nausea. Metallic taste in mouth. Blister on roof of mouth. Lymph node swelling under arm within a day or so, and into the neck by day 6. Very tender. Fevers continue but low grade and without chills or sweats. Right eye pain beginning first night -continuing still. Episodic hives first several days. Joint pain, nerve pain, muscle pain. Bright red joints and tendons episodically.
45 2021-05-09 pain in extremity, numbness Left leg numb swollen from thigh down to my feet and aching the whole leg however mostly in my knee.
45 2021-05-09 pain in extremity Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nau... Read more
Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nausea and vomiting. EKG showed T-wave inversion on V2 and pt was sent to the ED for further evaluation. At the ED, bloodwork showed a significantly elevated troponin level. Pt was admitted for a possible NSTEMI and placed on a heparin gtt, diagnosis changed to myocardial injury within the setting of myo/pericarditis.
45 2021-05-09 tremor Commencing at 7:00 pm on vaccination date numbness in mouth and metallic taste, nausea, dizziness. A... Read more
Commencing at 7:00 pm on vaccination date numbness in mouth and metallic taste, nausea, dizziness. At approximately 9:00 pm extreme headache, extreme nausea, excruciating pain at injection site spreading down to hand. Threw up repeatedly. Temperature of 102. Chills and shaking , pain in lymphnodes, unable to arise from prone position. Diarrhea commenced around 1:00 am. Major symptoms subsided by noon following day and by 7:00 pm symptoms largely resolved. Had Covid in March 2020 no test as not available at time. Tested positive for antibodies for several months. ER visit in May 2020 severe inflammation and pain during menstration. Had to have hysterectomy on March 9,2021. Daughter in ER week after me with alleged HSP but confident she had MIS-C. I am Rh negative. I truly hope this helps with future care for others.
45 2021-05-10 numbness Within an hour half of my body went numb My tongue went numb and I was in the emergency room unable ... Read more
Within an hour half of my body went numb My tongue went numb and I was in the emergency room unable to speak with what appeared to be the worst hemiplegic migraine in my life. The feeling has not returned in my left hand side of my body or my tongue. I am told the second vaccine injection will be worse. Then I was misdiagnosed with muscular sclerosis after an MRI was done and damage was found to my brain. I could not be more angry
45 2021-05-10 pain in extremity Sore arm; This is a spontaneous report received from a contactable consumer (patient). A 45-year-ol... Read more
Sore arm; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid right on 19Feb2021 12:30 (Batch/Lot Number: EL9266) as single dose for covid-19 immunisation. Medical history included allergies: dogs, cats, pollen, dust, feathers, erythromycin. Historical vaccine included tetanus shot with flu like symptoms: fever. Concomitant medication included loratadine (CLARITINE) taken for allergies from an unspecified start date and ongoing. The patient experienced sore arm on 19Feb2021 14:00 with outcome of recovered. Patient received treatment Ibuprofen for the event. No follow-up attempts are needed. No further information is expected.
45 2021-05-10 pain in extremity excruciating pain in her arm; can't lift or rotate her arm more than 5 degrees; This is a spontaneou... Read more
excruciating pain in her arm; can't lift or rotate her arm more than 5 degrees; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm on 17Feb2021 (lot number: EM9810) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) for COVID-19 immunization. On 17Feb2021 17:00, the patient started to feel the symptoms. The patient had an excruciating pain in her arm and can't lift or rotate her arm more than 5 degrees. Therapeutic measures were taken as a result of the events which included treatment with Advil and ice. The outcome of the events was unknown.
45 2021-05-10 tingling, pain in extremity, burning sensation 4/3/21 - hives on right thigh, 4/5/21 extreme fatigue, 4/6/21 flu-like symptoms, 4/7/21 arms and leg... Read more
4/3/21 - hives on right thigh, 4/5/21 extreme fatigue, 4/6/21 flu-like symptoms, 4/7/21 arms and legs weakness and pain progressively got worse through 4/16/21 when mobility started decreasing, 4/19/21 fatigue, flu-like pain, lymph nodes sore, arms heavy & weak, 4/20/21 slight feverish feeling but no fever, throat sore, strange smell, nasal congestion, 4/20 COVID test negative 12:10pm at Urgent Care, 4/21 lungs burning, bronchitis, laryngitis, waves of feverish feeing with no fever, pain subsided but fatigue came back, 4/23 cold better but arms and legs painful heavy, 4/24 1pm extreme fatigue, arms and legs weak, can't walk or move, 4/25-5/7/21 Arms and legs like lead, extreme pain and weakness, burning feeling on legs, twitching crawling sensations, buzzing all over, hiccups, hearing loss, cannot walk or move arms much, had to crawl to the bathroom, only arms and legs affected, middle of body and head/brain was totally fine, prickly feeling on ankles, pins and needles on feet, burning and gnawing pain, layers of different kinds of pain, 4/27 pain started moving up to thigh from lower extremities to higher extremities (calf to thigh, wrist to upper arm), all over body throb (present throughout), 5/9 feeling better more able to walk, sharp pinching pain in left front thigh and right side calf, 5/10 right calf pain went away, left thigh more painful, visible dark spot on thigh, worried this is a clot, feeling of pinching pain.
45 2021-05-11 numbness Anaphylaxis Metal taste in mouth Numbing of face and lips
45 2021-05-11 tingling patient felt tingling in right arm.
45 2021-05-11 tremor Patient had fainted before with other shots, but had no reaction to the first shot so she wanted to ... Read more
Patient had fainted before with other shots, but had no reaction to the first shot so she wanted to get the second shot. About 10 minutes after getting the shot she said she was feeling dizzy and called her husband in. Patient fainted while sitting in the immunization chair and shook a little bit. She woke up in about half a minute and did not know where she was initially. Her husband came later and waited with her. Patient started feeling nauseous and vomited a small amount of yellow/orange fluid. Called the ambulance and they came and took her blood pressure. Patient went to get checked out at the hospital and she said they ran tests on her and said that it was probably just a reaction to the shot. Patient says she is doing much better now and sounded much better when I called her around 5:40 PM.
45 2021-05-12 hot flush I was taking medication for hypertension. While it has been slowly getting better over the last year... Read more
I was taking medication for hypertension. While it has been slowly getting better over the last year, it was still high enough to take meds, generally around 160/100 without. After the first vaccine it went very low, like 90's/50's, very rare for me. After second dose it went up and I took a pill that next day as it was 178/105. That night it went VERY low, and that is the last medication for hypertension I have taken. My BP has remained low, and most all nights it gets to the 90's/50's. PCP, Nephrologist, and myself are monitoring. I also have had issues over last two weeks such as hot flashes/sweats (thought it was due to low BP), and started having blood in my urine last week, with some feeling like it was my period. I haven't had a period since my transplant 22 years ago, so this is odd and I have a dr appoint scheduled for next week to look into it.
45 2021-05-12 muscle spasms Very painful period craps.
45 2021-05-12 paralysis complete paralysis/paralyzed/can't move anywhere/can't move her arms and legs; muscle weakness; This... Read more
complete paralysis/paralyzed/can't move anywhere/can't move her arms and legs; muscle weakness; This is a spontaneous report from two contactable consumers (patient herself and her husband). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, administered in the right arm (also reported as right shoulder), on 13Apr2021, as 1st dose, single, for COVID-19 immunization, at a pharmacy/drug store. Medical history included allergies to latex, bulimia, depression, and COVID-19 (prior to vaccination). The patient previously took codeine and experienced allergies. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID-19 since the vaccination. Concomitant medications were unspecified (taking other medications). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 16Apr2021, the patient experienced complete paralysis which started with muscle weakness 3 days after the vaccine. The events resulted in emergency room visit, hospitalization (also reported as prolonged hospitalization, pending clarification), disability or permanent damage. The patient was still in the hospital at the time of the report. Treatment for the events included spinal tap, IV fluids, and potassium intake treatment. On 29Apr2021, it was reported that the patient was having a really bad reaction (unspecified), was paralyzed, could not move anywhere and in the hospital from 25Apr2021 and ongoing. The patient underwent lab tests in Apr2021 with unknown results. On 08May201, it was reported that the patient could not move her arms and legs and is "nursing home" (pending clarification). The reporter assessed the events as serious (hospitalization and disability). The outcome of the events was not recovered.
45 2021-05-12 tenderness, pain in extremity Painful and tender arm, unable to lift. Slowly improving today (next day). Nausea during the night o... Read more
Painful and tender arm, unable to lift. Slowly improving today (next day). Nausea during the night of 12th May. Shivers during night of 12th May. Nausea and shivers lasted about three hours at night, revolved upon waking up in the morning of 13th Severe headache during the night of 12th May, improving on 13th May
45 2021-05-13 numbness Numbness in fingers, Lymph nodes swollen, chest and underarm pain, feverish -after 2 weeks
45 2021-05-14 inability to speak My endometriosis hurt so bad I wanted to die, couldn?t speak, couldn?t move, couldn?t call for help.... Read more
My endometriosis hurt so bad I wanted to die, couldn?t speak, couldn?t move, couldn?t call for help. Would have called 911 if I could have made a telephone call. There is no way to describe the pain if was so bad. I think torture is the only way to compare. I would have done anything, signed anything, chosen death if it made the pain stop. I lived on 800mg of ibuprofen every 4 hours for three days to bring it down to a ?livable? amount of pain. Will this happen again next month is my question. I will not get the second shot or any other shots in the future. Would rather die.
45 2021-05-14 muscle spasms, migraine Symptoms: beyond normal muscle spasms, very blinding migraine ( mostly on right side of back of head... Read more
Symptoms: beyond normal muscle spasms, very blinding migraine ( mostly on right side of back of head), clothes changing sweats, dehydration, inability to walk, all over body pain.
45 2021-05-14 nerve pain I had my first Shingles/ Herpes Zoster outbreak. The outbreak includes rash and nerve pain. I did h... Read more
I had my first Shingles/ Herpes Zoster outbreak. The outbreak includes rash and nerve pain. I did have the chicken pox as a child. However, I have no other underlying medical conditions.
45 2021-05-16 weakness Fever of 103, severe body aches, trouble standing, no energy. Strange dreams
45 2021-05-16 numbness, tingling 3 days after receiving my 1st COVID vaccine, I had a CBC draw. My platelet count went from < 400 to... Read more
3 days after receiving my 1st COVID vaccine, I had a CBC draw. My platelet count went from < 400 to > 450. I also experienced heaviness in both my arms and tingling/numbness in my fingers. Platelet count resolution is TBD (will get retested 6 weeks post 2nd shot). Heaviness in arms/tingling in fingers resolved after one week.
45 2021-05-16 pain in extremity, tingling This is not a confirmed adverse effect but a potential relationship. About 2 weeks after my second ... Read more
This is not a confirmed adverse effect but a potential relationship. About 2 weeks after my second dose I was having major pain and tingling in my left leg. Shortly after I got rash and very painful blisters on my left buttock, crack, and anus. Went to urgent care and was diagnosed with Shingles. I am On a two week cycle of Humira. My last dose was on April 29.
45 2021-05-16 pain in extremity This is not an adverse event report, but a vaccine administration error. Patient received first dose... Read more
This is not an adverse event report, but a vaccine administration error. Patient received first dose Moderna COVID vaccine 4/9 at other location, and was given Pfizer COVID vaccine as her second dose on 5/13 at Pharmacy. On the consent form, both Moderna and Pfizer were marked as first dose and the agency pharmacist couldn't recall the situation. We finally reach the patient on 5/16 and clarified her first dose was Moderna. Patient stated she felt tired after she received the vaccine, and while on the phone she stated she's feeling fine with a little sore arm. Pharmacist informed her per CDC, she doesn't need another COVID shot.
45 2021-05-16 pain in extremity Swelling, stiffness, rash, itching and pain in hands and feet. Follow-up itching all over body.
45 2021-05-16 seizure AT AN OFFSITE CLINIC, SHE HAD 3 SEIZURES AFTER RECEIVING HER 1ST COVID VACCINE. 911 WAS CALLED AND R... Read more
AT AN OFFSITE CLINIC, SHE HAD 3 SEIZURES AFTER RECEIVING HER 1ST COVID VACCINE. 911 WAS CALLED AND RESPONDED. VITALS LISTED BELOW. EMS SAID SHE WAS DEHYDRATED AND STARTED AN IV OF NORMAL SALINE, THEN SHE HAD A 4TH SEIZURE. SHE WAS TRANSPORTED TO RECEIVING HOSPITAL. SHE HAD ORIGINALLY STATED ON HER CONSENT SHE DIDN'T HAVE ANY HEALTH CONDITIONS. HER HUSBAND EXPLAINED WHAT SHE HAS. AND SHE SAID SHE HAD TAKEN HER MEDICATIONS THAT DAY AND HER HUSBAND SAID SHE HADN'T TAKEN HER MEDICATION THAT DAY.
45 2021-05-17 facial paralysis The whole left side of my face has facial paralysis. Being treated as if it were Bell Palsy because ... Read more
The whole left side of my face has facial paralysis. Being treated as if it were Bell Palsy because we are not sure if this is a side effect from receiving the vaccination.
45 2021-05-17 migraine I had my migraines under control for years until 2 weeks ago. Headaches and migraines are becoming m... Read more
I had my migraines under control for years until 2 weeks ago. Headaches and migraines are becoming more prominent in my daily life. My sense of smell has also became very heightened.
45 2021-05-17 tingling Tingling/pins & needles starting in left hand, travelling up left arm to elbow, left side of neck/fa... Read more
Tingling/pins & needles starting in left hand, travelling up left arm to elbow, left side of neck/face, then in left foot. Eventually to right hand and foot. Consistent/intense for several hours. 24-48 hours later turned into transient tingling - mostly hands and feet, but also mid section, face, on and off. Has not resolved.
45 2021-05-18 burning sensation, nerve pain very sore arm at injection site as well as her left elbow; very sore arm at injection site; burning ... Read more
very sore arm at injection site as well as her left elbow; very sore arm at injection site; burning around her elbow; woke up to a very sore arm--at injection site as well as her left elbow; nerve pain; felt slightly nauseated; I was fatigued that night; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left on 27Apr2021 15:00 (received at 45-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccines. Medical history included hypothyroidism, arthritis, broken elbow 11 months ago (from 2020), and dairy sensitivity. She had no COVID prior vaccination and was not tested post vaccination. She was not pregnant. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:15 (received at 45-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient got her 2nd shot on 27Apr2021 and felt slightly nauseated at first. This went away. She was fatigued that night. The next morning, on 28Apr2021 07:00 AM, she woke up to a very sore arm at injection site as well as her left elbow (that she broke 11 months ago). She had dull aching pain, as well as burning around her elbow. She has been told that it's nerve pain. It is slowly getting better. As corrective treatment, the patient received Motrin, ice, and physical therapy. Outcome of the event was recovering.
45 2021-05-18 feeling jittery, flushing I have experienced mild dizziness off and on after the shot since about a half hour after first dose... Read more
I have experienced mild dizziness off and on after the shot since about a half hour after first dose. But today, 6 days after first dose, at around Noon, I experienced a stronger episode of dizziness which then progressed to a presyncope feeling (like I might pass out). I also felt flushed and jittery after the presyncope subsided. Now, I still feel dizzy, off balance and jittery.
45 2021-05-18 flushing, pain in extremity Quite quickly, I started tasting metal in my mouth. It disappeared within a few hours. My left arm p... Read more
Quite quickly, I started tasting metal in my mouth. It disappeared within a few hours. My left arm pain was insanely intense. It felt like someone had run over my arm with a car. It was so bad, but it went to just sore arm by the next day. Headache, fatigue, nausea and really flu-like symptoms lasted until 48 hours, then started to disappear.
45 2021-05-18 numbness, tingling The next day after my first shot, my left leg felt heavy, numb, tingling, and sore
45 2021-05-18 numbness AT 15 minutes ran for Diarrhea. At 20-30 minutes my face went numb but was mostly left sided but pa... Read more
AT 15 minutes ran for Diarrhea. At 20-30 minutes my face went numb but was mostly left sided but part of top right too. Called doctor and while on hold a lump developed in my throat and I felt so parched I could not drink enough water to help that lump in my throat. As I could still breathe the doctor said go home and take Benadryl for the weekend. I started a Benadryl regimen as soon as I got home one every 4 hours until I fell asleep. The next morning I felt fatigued and the face numbness turned into this pressure headache mainly on the left side (that is still present at day 12). The lump in my throat was gone and never returned. I took more benadryl that evening a couple times 4 hours apart. Mainly fatigued and pressure headache with occasional nausea. This continued until Monday. I wasn't fatigued on Monday-Wednesday but I had minor chest aches which I had in the past due to costochondritis/scar tissue. Thursday I felt much worse upon waking, like I was sick with the flu again. I continued about my day until 11am the chest aches/pains turned into the worst pain of my life (short of child birth). I called 911 as we were driving to the hospital asking if it would be better for us to pull over as I wasn't sure I would make it to the hospital. He said the time would probably be slower as they'd have to locate me so my husband took me. The pain was a level 10, I felt the most immense pressure but due to having 4 children knew Lamaze breathing helped with the pain. Tears rolling down my face and breathing Lamaze was the only thing keeping me from screaming with pain. The ER ran a broad spectrum of tests and found nothing showing, but relayed how it was most likely the vaccine shot 2. I had also read intense inflammation can follow the vaccine shots. Which would make sense since my lungs do occasionally get inflamed. Accompanied with all of this I am unable to walk, do chores and sometimes just while sitting I cannot catch my breath. I will take slow deep breaths until I cant breathe again within 20-30 minutes. This mornign while unloading the dishwasher I became winded! I'm not a runner by any means, but I move daily, I take our daughter to swim team, run errands, do dishes, etc. I am having to stop and take deep breaths to catch my breath again. The catching my breath has worsened over the last 3 days and I do not know why. I have a follow up appt with my doctor tomorrow.
45 2021-05-19 weakness, migraine Migraine, muscle aches, weak, exhausted, a lump and red rash on left arm near injection. On the 16th... Read more
Migraine, muscle aches, weak, exhausted, a lump and red rash on left arm near injection. On the 16th, diarrhea and continued exhaustion (lasted 5 days)
45 2021-05-19 feeling hot, cold sweat Itchy all over, tired, warm feeling all over, clammy
45 2021-05-19 pain in extremity, burning sensation, mild one side paralysis, muscle spasms Cramping of fingers; Burning hands; Itching on hand palms/itching on feet; Painful L arm; Blood pres... Read more
Cramping of fingers; Burning hands; Itching on hand palms/itching on feet; Painful L arm; Blood pressure high; Weakness in left side; Chills; Ears ringing; Flu like symptoms; Fever; This is a solicited report from a non-contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EP7533) via an unspecified route of administration on 07Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunization and adalimumab (HUMIRA; solution for injection in pre-filled pen; strength: 40mg/0.4mL) subcutaneously from 2016 and ongoing at 40mg, weekly (CF, 40mg, 1 in 1 week) for moderate to severe rheumatoid arthritis and ulcerative colitis. Medical history included megaloblastic anemia, allergic to aspirin, allergic to penicillin, allergic to shellfish, allergic to tramadol, rheumatoid arthritis, ulcerative colitis, abstains alcohol, acid reflux and allergy all from unspecified dates and unspecified if ongoing. The patient had no tobacco use. Concomitant medications included methotrexate taken for an unspecified indication on unspecified dates, folic acid taken for an unspecified indication on unspecified dates, dexlansoprazole (DEXILANT) taken for an unspecified indication on unspecified dates, dexlansoprazole (DEXILANT) taken for acid reflux on unspecified dates, montelukast sodium (SINGULAIR) taken for an unspecified indication on unspecified dates, cetirizine hydrochloride (CETIRIZINE) taken for allergy on unspecified dates, fluticasone propionate (FLONASE) taken for an unspecified indication on unspecified dates and salbutamol (ALBUTEROL) taken for an unspecified indication on unspecified dates. On 07Apr2021 the patient experienced chills, ears ringing, flu like symptoms and fever; on 22Apr2021 the patient experienced weakness in left side, painful L (left) arm and blood pressure high; on 25Apr2021 the patient experienced burning hands and Itching on hand palms/itching on feet and on an unspecified date the patient experienced cramping of fingers. The events were all assessed as non-serious. The action taken in response to the events for adalimumab was dose not changed. The clinical outcomes of the events chills, ears ringing, flu like symptoms and fever were recovered/resolved on 07Apr2021; weakness in left side, painful L arm, blood pressure high, burning hands and Itching on hand palms/itching on feet were recovered/resolved on an unspecified date and cramping of fingers was not recovered/not resolved. The reporter's causality for the events chills, weakness in left side, Itching on hand palms/itching on feet, burning hands, ears ringing, flu like symptoms, fever, painful L arm, blood pressure high and cramping of fingers with adalimumab was no reasonable possibility. The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information provided, a causal association between suspect drug and the reported events cannot be completely excluded considering a temporal relationship. Case will be reassess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
45 2021-05-19 pain in extremity, numbness Starting the day after my 2nd shot, I started to experience lower back pain. Over the following wee... Read more
Starting the day after my 2nd shot, I started to experience lower back pain. Over the following week, the pain intensified until it was so excruciating that I was completely debilitated. I was prescribed a steroid anti inflammatory and muscle relaxants. The next day the pain included radiating leg pain and numbness down my calf and including several toes. The pain was unbearable and the doctor recommended I go to the emergency room, which I did. At the ER I was given 2 injections. One, a powerful pain killer, (dilaudid), and the other, an anti-inflammatory, (toradol). After the powerful pain killer from the ER, the back pain mostly subsided, but the radiating leg pain and numbness persisted very intensely for the first few weeks, and less now, but it's still not gone. I had a previous experience about 15 years ago of excruciating back pain due to a herniated disc, but my back has been doing well for the last 10 years or so and there was nothing I?m aware of that might have set it off. While I can?t say for sure if it was caused by the 2nd vaccine shot, because of the time correlation and after reading that extreme back pain can be a symptom of covid, I thought it was worth reporting.
45 2021-05-20 feeling cold, tingling Immediately following the shot in my left upper arm, I experienced a cold sensation in my upper left... Read more
Immediately following the shot in my left upper arm, I experienced a cold sensation in my upper left arm. That sensation gradually moved throughout my arm. A bit later I felt pins and needles in both hands. The cold sensation in my arm and pins and needle feelings in my hands lasted for 2-3 hours following the shot, then went away. There was no pain but it was disconcerting. I was told to report the reaction.
45 2021-05-20 flushing Generalized flushing, Urticaria upper torso and sparse to uppe thighs, No SOB,NO STRIDOR Lungs clear... Read more
Generalized flushing, Urticaria upper torso and sparse to uppe thighs, No SOB,NO STRIDOR Lungs clear Treated with Epi 0.5mg IM, and Benadryl 50mg IM Right Deltoid Sent via EMS to the ER
45 2021-05-20 tingling, numbness Patient c/o left-sided facial and arm tingling about 5 min after receiving 2nd dose of Pfizer. RN n... Read more
Patient c/o left-sided facial and arm tingling about 5 min after receiving 2nd dose of Pfizer. RN noted pt to be diaphoretic, anxious, and hypertensive on assessment. BP 198/118 at 0905. Pt states she has been diagnosed with borderline htn in the past, but hasn't seen a provider since before 12/2019. Numbness/tingling subsided after about 5 minutes and did not return. BP 162/104 30 min after event, patient reported feeling better. Upon follow-up, patient stated her bp did not improve. She will be seen at Health Department in primary care on Monday, 05/24/2021 for follow-up.
45 2021-05-21 cold sweat After 1 min of receiving Pfzier COVID Vaccine pt was dizzy. Then sweaty and calmy. Pt sat and drank... Read more
After 1 min of receiving Pfzier COVID Vaccine pt was dizzy. Then sweaty and calmy. Pt sat and drank water and after a few minutes cold pack on back of the neck helped the dizziness and sweatiness. Pt was in vaccination room for about 5 mins and then felt better. She sat outside for another 5 mins. She felt better and was up and shopping. Called in late afternoon to follow up, left message for patient and to take APAP for muscle soreness and any flu like symptoms
45 2021-05-21 pain in extremity, weakness Fever 100.8 x 30 hours chills headache in nape of neck. unsteady arm soreness weak no sleep little a... Read more
Fever 100.8 x 30 hours chills headache in nape of neck. unsteady arm soreness weak no sleep little appetite felt very very bad after 2nd dose on April 27. Awoke sweating profusely bed damp pajamas damn at 6:30 on Thursday, April 29 to loud ringing buzzing whining in both ears. Pressure in ears soreness in ears deep where ears meet brain. Feels as if ears will burst if I lean over. Headache in forehead. Fever 99.0 -99.4. Ear pressure aching ringing has continued since. At times, left ear feels like a void like I can?t hear. Right ear like it hears too well too loud. Music songs sound different. Like not blended. Like missing a part. When 2 many sounds happening, I can?t distinguish detail. It?s all blurred. An ambulance went by. I couldn?t hear with my left ear. Seatbelt beeping in car is faint and does not bother me now.
45 2021-05-22 weakness, hot flush Mild fever, hot flashes, irritability, lack of energy, tired, felt drained/worn out, left shoulder j... Read more
Mild fever, hot flashes, irritability, lack of energy, tired, felt drained/worn out, left shoulder joint pain (maybe about a 5), left arm muscle pain (about a 3) and left elbow joint pain (about a 5 or 6).
45 2021-05-22 feeling hot SOB, feeling hot. Started 5 minutes after injection, lasted a few minutes. Did not recur with second... Read more
SOB, feeling hot. Started 5 minutes after injection, lasted a few minutes. Did not recur with second dose.
45 2021-05-23 weakness, cold sweat, flushing, tremor Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-M... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: pt started feeling weak, shaky, clammy, nauseated, flusg and sweating after pzizer vaccine adminstration. pt had a fainting spell. gave pt epi-pen and called 911. i had pt lie down with her feet elevated. paramedics got her vitals and it was normal. BP (120/80), normal HR. After a few minutes of rest, pt felt better. she did not go to the hospital. advised pt to seek her pcp for further advise to get the 2nd dose.
45 2021-05-23 concussion 2/9/21 :My legs went weak one week later and I fell on the floor and suffered a concussion by hittin... Read more
2/9/21 :My legs went weak one week later and I fell on the floor and suffered a concussion by hitting my chin on the concrete floor. I was able to get up with help and get to class. 3/26/21: My legs went weak completely while standing from my couch at home and my 17 year old son caught me so that I did not hit my head as I fell.
45 2021-05-23 difficulty speaking, pain in extremity I am a very active fit person that has consistently exercised 6 days a week for the past 15+ years d... Read more
I am a very active fit person that has consistently exercised 6 days a week for the past 15+ years doing CrossFit style workouts and also a consistent runner (half marathon). My heart rate and blood pressure are always very low due to my active lifestyle. Normally my resting heart rate is in the 50's or low 60's and my blood pressure around 100-110/60-65. My health was great - I exercised, worked, was active with my kids, and never had any of these symptoms prior to the 1st dose of the Pfizer vaccine. Days 1-2 post vaccine, I only experienced sore arm, my throat became tight/raspier, and a little tired. A few days after 1st shot, I had a big heart palpitation that woke me from deep sleep and heart was racing/pounding in the middle of the night. Next couple days noticed heart was working really hard doing the simplest things like standing up, laundry, or walking up the stairs. Heart rate was faster, my blood pressure was higher at rest, and my left arm where I had the shot continually felt tingly/numb. On day 6, about 1-2 hours after working out while sitting at my computer working, I developed the most intense crushing chest pain, high BP, extreme fogginess/brain fog (couldn't see the words on the screen), nauseous, felt like I might vomit, light headed, my outer fingers in left hand couldn't function and type (they curled up), and thought I was going to pass out. I laid down and took a nap. Day 7, my overall body feels off with similar symptoms. Day 8, I tried working out again and ended up experiencing the same debilitating symptoms described above plus chills but worse which sent me to the ER. They ran a battery of tests (EKG, blood work, chest x-ray, abdominal ultrasound) to rule out a blood clot from vaccine or heart attack. All tests normal and sent home. Days 9-21 - overall body feels weak from head to toe, low energy, smallest movements make heart race/pound, chest feels achy (squeezing pressure at times), left arm is still tingly, brain fog is terrible, nausea off/on, appetite is off, losing weight, high BP for me (130-140/80-90's), dizziness, tighter/raspier throat, bra and pants feel like putting pressure on chest/stomach (so not wearing them), sitting can feel like compressing something so have to get up frequently, hard time focusing, and haven't exercised at all for 2 weeks. Exerting too much energy seems to make things worse. Aside from these regular symptoms, I keep having "episodes" where things get worse and feel like I may pass out. I followed up with my doctor around day 12 and she ordered a 48 hr heart holter monitor and heart stress test. Day 22 (5/13) - another intense episode that sends me back to the ER (same symptoms described above plus a very painful lump feeling on left arm near where vaccine was given that developed couple days prior). Repeat blood work and chest x-ray. Day 23-31 (today), while my energy level has started improving and overall I don't feel as awful head to toe as before, I still have chest discomfort/heart racing with little exertion, higher BP than my normal, brain fog, sometimes feel like might pass out, left arm still tingly, and have noticed my feet turn bright red when I am standing (not even for a long time). Laying down seems to help relieve some of these symptoms. I have another follow up appointment with my doctor this week. There is no doubt, the vaccine triggered something in my body causing these symptoms. Now I just want to know how to treat it so I can get back to feeling 100% like myself before I had the shot. I will NOT be getting the 2nd dose due to these extreme and alarming symptoms I have been experiencing for over a month now.
45 2021-05-23 feeling hot Started with a headache and nausia then went to vomiting on and off the next 12 hours. Had a feve... Read more
Started with a headache and nausia then went to vomiting on and off the next 12 hours. Had a fever that spiked to 102 with chills and body aches. Took tylenol but didn't reduce symptoms. Rested and drank lots of water. Began having bone aches where the inside of my bones feel hot, but the skin feels cold on top. The bone aches began Sunday morning and have continued. They get more intense the more I walk. The headache severity has reduced, still have a lingering headache in the back of my head. My fever today is at 100 and still have chills.
45 2021-05-23 tingling, migraine, inability to speak Expressive aphasia. Migraine. Scotoma. Right hand paresthesia.
45 2021-05-23 tingling, pain in extremity, numbness Developed waves of tingling and numbness in feet and hands. Developed lower back pain night of vacc... Read more
Developed waves of tingling and numbness in feet and hands. Developed lower back pain night of vaccination. Next day developed continuous numbness in left side of face, periodic numbness in left neck, left shoulder, and left side of head. The tingling escalated for about 6 days to the point it felt like my entire nervous system was vibrating. Lower back pain persisted more frequently, likely sciatic nerve pain. Around day 21 the tingling began to get better, but developed pain in fingertips and toes. Pain came in waves but was transient. Today is almost day 39 post vaccination, still have minor transient tingling in feet and hand. Transient less frequent pain in fingertips and toes. Numbness in face/head seems to be gone.
45 2021-05-24 cold sweat felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of... Read more
felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of bed; debilitating panic attack; Short of breath; Cold sweat; Dizzy; Racing heart; This is a spontaneous report received from a contactable health care professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 15Feb2021 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination was reported. No other vaccine administered in four weeks. The patient previously received erythromycin, tetracycline, clindamycin hydrochloride (CLEOCIN), sulfamethoxazole/trimethoprim (BACTRIM), and all were reported as known allergies. It was reported that the day after this injection on 16Feb2021 she had a debilitating panic attack, short of breath, cold sweat, racing heart, dizzy. She had felt overly anxious since having the injection this past Monday (15Feb2021). Getting out of bed started up her feelings of anxiousness. She had spent the better part of a week scared to get out of bed. No treatment was received due to event. Patient was not tested for COVID post-vaccination. The outcome of the events was not resolved. Information on the lot/batch number has been requested. Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
45 2021-05-24 slurring On 05/19/21 experience slur speech with words. I see and think of the word/words clearly but when pr... Read more
On 05/19/21 experience slur speech with words. I see and think of the word/words clearly but when pronunciation they came out incorrect . ( Irritated slurred) no pain . It lasted several days not until Monday May 24, 2021. I felt normal.
45 2021-05-24 numbness, tremor, flushing Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Med... Read more
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Mild, Additional Details: Patient experienced numbness in the face along with difficult swallowing and an itching and closing sensation in the throat starting about 30 minutes after the injection. patient remained conscious and the symptoms subsided within an hour of the injection. no medications needed to be administered.
45 2021-05-24 numbness Within an hour, extreme headache, left side of entire body ;limp/numb, tongue and face numb-- nexty ... Read more
Within an hour, extreme headache, left side of entire body ;limp/numb, tongue and face numb-- nexty day, entire body numb, except extreme pain and stinging wrists, hands, feet, mouth, ear to ear (trigeminal) extreme pain, difficulty wakling cannot use body strength came back and left again today 5/25 started course of methlyprednisone which will make me have weakened immune system fear getting covid now as I have to be around people I have not contracted covid. Docs at a aloss. said I was having signs of MS I do not have MS MS medically, and legally requires LP MRI is no longer gold standard for MS I went to school for things A transfection and expression event took place in my arm without my permssion after I was fear mongered to get this being told I would die if I did not I fear death now I have loss of function in arms and hands, I cannot do homework, it is difficult to ype, my hands feel like I am being stung by bees I just moved here because I was the main witness in a jury trial Upset is not the word I would use to describe
45 2021-05-24 numbness Pt became dizzy after injection. VS were stable and as follow: BP 118/80, 116/80, 120/80, & 118/80;... Read more
Pt became dizzy after injection. VS were stable and as follow: BP 118/80, 116/80, 120/80, & 118/80; HR 80, 78, 73, &72; OxSat 98%, 98%, 98%, & 97%. Ice pack applied to neck, lying supine on a cot. Reported feeling better. Started feeling dizzy again. EMS called. Also became nauseated over the course. It was reported that patient only had egg w/coffee for breakfast. Took a few sips of V8 fruit and drink prior to EMS arrival. Vitals obtained by EMS also stable but pt continued to gag/vomiting sounds. Was able to sit and stand. Reported she felt better after EMS suggested transport for further evaluation. Pt continued to gag (but no actual vomit) The moment she does any movement pt gets dizzy. Did reporte early on some numbness left hand. Transported to the ER by EMS @2:10PM
45 2021-05-24 migraine Face got swollen and I continue to experience sudden swelling of face, discharge/clotting when not o... Read more
Face got swollen and I continue to experience sudden swelling of face, discharge/clotting when not on menstrual cycle, dizzy spells, fatigue, headaches/migraines ongoing, shortness of breathe.
45 2021-05-24 muscle twitching, discomfort The next morning after my vaccine my arm starting twitching and then swelling under my armpit. I to... Read more
The next morning after my vaccine my arm starting twitching and then swelling under my armpit. I took Tylenol. I couldn't sleep on that side it was very uncomfortable. I called my doctor, he said to take motion. I felt better after taking the motrin.
45 2021-05-24 pain in extremity The evening of receiving the vaccine, at around 10pm I started feeling pain in both my hands. It fel... Read more
The evening of receiving the vaccine, at around 10pm I started feeling pain in both my hands. It felt like I had baseball gloves on they were throbbing and very painful later that night I experienced that excruciating pain in all my joints. I couldn't stand up for a few days The excruciating pain went away but pain still remains. The pain lasted for 9 weeks. I also had vertigo I also had covid toes and fingers. I had blistering at the base of my nails and my toes were bright red. I also had rashes. They were little red pinprick like rashes on my arms and neck. I was also extremely fatigued. I contacted my primary care doctor on day 7. She said not to worry. I then contacted my acupuncturist. I then received acupuncture 2x a week along with a gentle movement program. The acupuncture helped temporarily. At week 2 I contacted the infectious disease doctor. I was put on a waitlist and I got in at 4 weeks. We did inflammatory markers and she advised I not get the second dose. She said I have a profile of a hypersensitive immune system. I still have pain in my fingers and toes which comes and goes. I have not received the second dose. I had testing done throughout 2020 but none were positive. I believe I had COVID in February 2020. The antibodies were still present in January 2021. I was also on an anti inflammatory diet.
45 2021-05-24 tingling Tingling, subjective SOB. lasted less than an hour. Recurred iwth second dose. No treatment needed.
45 2021-05-25 weakness, pain in extremity nausea; vomiting/almost threw up with severe; almost threw up with severe,frightening, severe, heart... Read more
nausea; vomiting/almost threw up with severe; almost threw up with severe,frightening, severe, heartburn, felt like esophagus was going to burst it hurt so bad; almost threw up with severe,frightening, severe, heartburn, felt like esophagus was going to burst it hurt so bad; fever of 101 all day; Caller almost passed out at one point; feeling terrible; dizzy; weak after second dose; chills/got really bad chills; arm started hurting all at once; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 03May2021 10:00 (Batch/Lot Number: ER8731) as 2nd dose, single for covid-19 immunisation. Medical history included she was very sensitive to medications and had a heart burn before. The patient's concomitant medications were not reported. The patient previously had a flu shot more than a month ago and experienced pain in joints for like a couple of weeks. The patient received first dose of bnt162b2 on 12Apr2021 (Lot: ER8734; left shoulder at 10:00) for COVID-19 immunization and experienced chills for like a week after the first dose, arm was sore and numbness inside mouth and face. Patient reported that she had no side effects occurred after second dose of the vaccine until about 2300, 12 hours after caller received the second dose. On 03May2021, 23:30, she was dizzy, and was weak after second dose. What started it was she got really bad chills, she tried to get up and was dizzy, felt like she couldn't stand up without holding onto something. The dizziness was ongoing maybe a little bit, probably related to the fact she can't eat more than the vaccination itself. She stated the dizziness was probably a lot less, and she was able to walk around now. Her bad chills were not ongoing and didn't last all that long. It lasted an hour that night of 03May2021 and she had chills again yesterday, 04May2021, when fever was going back up. They were really not that bad and stated that chills were gone now and recovered completely. On 03May2021, 23:30, her arm was sore; she reported that it started hurting all at once 23:30 on 03May2021. It was pretty severe, felt like entire arm it went through, it wasn't just like it went through to inside of her arm. It was where lymph nodes were and partially across chest. It was still sore but definitely not anywhere near the degree it was Monday night, 03May2021. She stated that it has improved. On 04May2021, around 18:00, the patient experienced nausea and vomiting but this was different, hasn't thrown up, almost threw up with severe, frightening, severe, heartburn, felt like esophagus was going to burst it hurt so bad. Patient reported that she has had heart burn before but she doesn't typically suffer from it and this was beyond, extremely painful. The events lasted about an hour. She immediately took some antacid tablets, but they did not work. Her husband got her Tagamet, by the time the she took it she felt a lot better. The patient guessed that she recovered with lasting effects. She tried to drink plain broth with nothing, no noodles. This was why she called because acid started jumping up into her throat from drinking that. She was afraid to eat, and she was going to have to eat at some point. On 04May2021, the patient almost passed out at one point, felt like she was going to pee her pants because of the pain, and it hurts so bad. She was close to calling 911 it was scaring her that much. This occurred after she had just eaten a small roll with butter on it. She also had fever of 101 all day, Tuesday (04May2021). She doesn't know when this began, and she finally took temperature mid-day, husband bought a new thermometer and she didn't realize she had a fever. She was taking Tylenol every 8 hours. She wondered if the Tylenol bothered her, she doesn't usually take Tylenol and she was told not to take Ibuprofen by the lady who gave her the second dose vaccination. She did take one Ibuprofen last night because she was feeling terrible and she felt a lot better. The events did not required a visit to the emergency room or physician office. Outcome of event almost passed out at one point, fever of 101 all day, weak after second dose was unknown; nausea, vomiting/almost threw up with severe, almost threw up with severe, frightening, severe, heartburn, felt like esophagus was going to burst it hurt so bad was recovered with sequel; dizzy, arm started hurting all at once and feeling terrible was recovering; and chills/got really bad chills was recovered on an unspecified date.
45 2021-05-25 difficulty speaking Two days after the 2nd Pfizer vaccine, Sunday May23rd, I woke up with a slight sore throat. I didn?... Read more
Two days after the 2nd Pfizer vaccine, Sunday May23rd, I woke up with a slight sore throat. I didn?t make much of it because I thought it was maybe my sinuses dripping more than usual. However, when I woke up Monday, the sore throat was evident and very bothering some. Throughout the day I experienced cold/flu symptoms like tiredness & coughing. I couldn?t function normal so I had to take DayQuil. At night in order to go to sleep I had to take NyQuil. Tuesday morning I woke up feeling worse, my nose was very congested, the sore throat persisted and my voice was changing. Very tired. I still did not have a fever, muscle aches nor chills. Although I did have a congested nose, I did not lose the sense of smell & taste. Today, Wednesday I lost my voice so I?m writing this. I haven?t had a cold in 2 years nor o have been exposed to people or places to catch COVID 19 so I?m almost positive these are side effects and symptoms from the Pfizer second vaccine. These symptoms needs to be brought out to the light. It is very unfair to feel like one is alone on this one. Fortunately, thanks to blogs I was able to read other bloggers who are experiencing the same symptoms, especially the SORE THROAT.
45 2021-05-25 pain in extremity Fainting; Sore arm; Abdominal pain; This is a spontaneous report from a contactable consumer (patien... Read more
Fainting; Sore arm; Abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164; Expiration date was not reported) on the left arm on 30Apr2021 (16:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date in 2021, the patient was fainting; had sore arm; and had abdominal pain. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date in 2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.
45 2021-05-26 burning sensation Developed rash in neck area resembles red spots with itching and burning sensation; Developed rash i... Read more
Developed rash in neck area resembles red spots with itching and burning sensation; Developed rash in neck area resembles red spots with itching and burning sensation; Developed rash in neck area resembles red spots with itching and burning sensation; Developed rash in neck area resembles red spots with itching and burning sensation; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) via an unspecified route of administration on 03Mar2021 at the age of 45-year-old female as a single dose for COVID-19 vaccination. The patient's medical history, concomitant medications and allergies to medications, food and other products were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. The facility where the most recent COVID-19 vaccine administered was other. On 12Mar2021, the patient experienced rash in neck area. The rash resembles red spots with itching and burning sensation. It started as small patch and is spreading even on the fourth day of the rash start. The treatment received for the events were unknown. The clinical outcome of events were unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
45 2021-05-26 seizure This is a 45-year-old female with past medical history of multiple sclerosis, hypothyroidism, pseudo... Read more
This is a 45-year-old female with past medical history of multiple sclerosis, hypothyroidism, pseudoseizures, conversion disorder, who presents to the emergency department from COVID-19 vaccination clinic after having a reported allergic reaction and seizure-like activity. She presents by EMS who reports that she was given intramuscular epinephrine as well as IV Benadryl for her symptoms. EMS reports that they saw generalized convulsive activity while the patient was alert and oriented, he reports this as "pseudoseizure-like activity". She was receiving her second dose of the COVID-19 vaccination today, she reports that she immediately thereafter got a rash to her torso and became short of breath. She was feeling well prior to the vaccination. She denies any other recent acute illnesses including fevers, chills, nausea, vomiting, diarrhea, chest pain. She says that she is currently undergoing a relapse of her multiple sclerosis and has been wheelchair-bound for 1 month. This is a 45-year-old female with past medical history of multiple sclerosis, hypothyroidism, pseudoseizures, conversion disorder, who presents to the emergency department from COVID-19 vaccination clinic after having a reported allergic reaction and seizure-like activity. She presents by EMS who reports that she was given intramuscular epinephrine as well as IV Benadryl for her symptoms. EMS reports that they saw generalized convulsive activity while the patient was alert and oriented, he reports this as "pseudoseizure-like activity". She was receiving her second dose of the COVID-19 vaccination today, she reports that she immediately thereafter got a rash to her torso and became short of breath. She was feeling well prior to the vaccination. She denies any other recent acute illnesses including fevers, chills, nausea, vomiting, diarrhea, chest pain. She says that she is currently undergoing a relapse of her multiple sclerosis and has been wheelchair-bound for 1 month.
45 2021-05-26 tremor Headache; dizziness; feeling shakiness of hands; This is a spontaneous report from a contactable Pha... Read more
Headache; dizziness; feeling shakiness of hands; This is a spontaneous report from a contactable Pharmacist. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El8982), via intramuscularly in left arm on 02Feb2021 at 10:00 AM as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El1283), via intramuscularly in left arm on 12Jan2021 as 1st dose, single for COVID-19 immunization. Medical history was not reported. Concomitant medications included multivitamins [vitamins nos] (MULTIVITAMIN) received within 2 weeks of vaccination. Patient had no allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 10:00 AM, patient experienced headache and dizziness reported immediately after vaccine. Patient also reported feeling shakiness of hands. No treatment was received for the adverse events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
45 2021-05-27 muscle twitching Left-sided facial twitching
45 2021-05-27 pain in extremity, muscle spasms So after the second injection on the 27th of Jan. I started to have flu like symptoms, body aches an... Read more
So after the second injection on the 27th of Jan. I started to have flu like symptoms, body aches and what not. The joint pain was minor. It was tolerable but as time went on it got worse. My medication that I was taking was not helping at all. It got to the point where I was walking, I had increased pain. When I was leaving work a couple days later I had trouble leaving work, I couldn't walk 25-40 feet to my vehicle after work. I had a severe spasm and my body was not functioning properly. I was finally able to make it to my vehicle. When I got to my vehicle I laid the seat back and laid there for about 15 minutes. I called a friend because I was really scared, I had never experienced that type of pain before. After about thirty minutes I was able to drive home. When I got home I had a lot of stiffness. When I took a step there were shooting pain in my left leg. I took ibuprofen 800mg and flexural. The next morning I was able to walk, I was still stiff but took a shower and went to work. At work someone saw me and got me a wheelchair at work, I am an RN. My husband took me to ortho on call. They did X-rays, they told me I needed to see an Orthopedic DR. On Feb 19th I started to see an orthopedic pain DR. On March 8th I started physical therapy, I did therapy 2x per week. They did an MRI, they determined I have a disc disease. On April 4th I had a steroid injection. I am scheduled to go back on June 9th for a possible another injection. I still cannot long distances but I know to take a break and it doesn't hurt as bad. I am constantly looking for a place to sit down. I am still being seen by an orthopedic DR.
45 2021-05-27 pain in extremity Sore arm the night of the vaccine. Progressed to sore arm, neck and left side of body throughout th... Read more
Sore arm the night of the vaccine. Progressed to sore arm, neck and left side of body throughout the night. Sunday afternoon I could feel a lymph node in the left side of my neck had swollen. Sunday night I started feeling sensitivity in my left jaw and teeth which progressed to my entire mouth the next day (Monday). Tuesday the sensitivity was only in the right side of my mouth. The right side of my mouth, especially my teeth hurt and is extremely sensitive when I drink and eat anything.
45 2021-05-27 pain in extremity FIRTS: TIREDNESS, ARM PAIN, ONE WEEK LATER: FEVER, MUSCLE ACHE, HEADACHE, EAR ACHE, THIRST
45 2021-05-28 weakness Fever; Chills; Body aches; No energy; Vomiting; Nauseous; Just don't feel like sitting up; This is a... Read more
Fever; Chills; Body aches; No energy; Vomiting; Nauseous; Just don't feel like sitting up; This is a spontaneous report from a contactable consumer (the patient). A 45-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, in left arm on 19May2021 17:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included iron deficiency anemia, migraines and pulmonary embolism (reported as PE's) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20May2021 03:00, the patient experienced fever, chills, body aches, no energy, vomiting, nauseous, just don't feel like sitting up. The consumer considered events as non-serious. The patient did not receive treatment for adverse events. Information on the lot/batch number has been requested.
45 2021-05-28 cold sweat NEAR SYNCOPE, C/O DIZZINESS, LIGHTHEADED, COLD, CLAMMY, DIAPHORECTIC. CODE GREEN CALLED, BP 99/66, ... Read more
NEAR SYNCOPE, C/O DIZZINESS, LIGHTHEADED, COLD, CLAMMY, DIAPHORECTIC. CODE GREEN CALLED, BP 99/66, HR 74, BLOOD SUGAR 94, HAD COFFEE FOR BREAKFAST. HYDRATION OFFERED, SX RESOLVED, NO TRANSPORT
45 2021-05-28 facial paralysis, bell's palsy Bell?s palsy. Started with pain in jaw and paralyzed right side of face a few days after pain began
45 2021-05-29 weakness, pain in extremity, discomfort After the second vaccination my general discomfort increased tiredness fatigue headache my legs hurt... Read more
After the second vaccination my general discomfort increased tiredness fatigue headache my legs hurt my hips wanting to vomit weakness.
45 2021-05-30 hot flush, pain in extremity I felt the following beginning Saturday morning; ? Severe leg aches, in addition to pain & swelling... Read more
I felt the following beginning Saturday morning; ? Severe leg aches, in addition to pain & swelling in my knees and ankles ? Hot flashes and sweats throughout the day and night ? Extremely lethargic Notes: The arm of the injection site only hurt for 24hrs. The effects above were extreme (bed ridden) from Saturday (22nd) to Tuesday (25th). All have lessened but are still present with the addition of a constant, dull ache in my right arm (opposite the injection site). I would just like to add that the ?side effects? I have experienced seemed to have intensified my existing ?aliments?. Pre vaccination: ? Mild knee pain (from jogging). ? Occasional night sweats - premenopausal symptoms
45 2021-05-30 tingling, feeling cold Pt states arm feels cold, tingling. Feels very nervous (has hx of anxiety attack). BP 151/94; HR 98;... Read more
Pt states arm feels cold, tingling. Feels very nervous (has hx of anxiety attack). BP 151/94; HR 98; RR 20. Given water, crackers, juice. Pt was reassured w/Spanish translator BP 133/73; HR 89; RR 20. Pt stable & release w/brother from vaccination site
45 2021-05-31 pain in extremity leg pains mostly left leg
45 2021-06-01 breast pain, numbness, pain in extremity Bumps on lips after both injections (cold sores) Given Valacyclovir and Acyclovir - Cleared after 7... Read more
Bumps on lips after both injections (cold sores) Given Valacyclovir and Acyclovir - Cleared after 7 day treatment Left Breast Indentation/Hardness/Separation/tenderness - Sent for Mammogram/Ultrasound - Nothing showed on either test except swollen lymph nodes - return in 3 months for recheck. Symptoms ongoing. Other symptoms include more common sore arm, chills, rash arm, swollen lymph nodes, numbness, fatigue, headaches.
45 2021-06-01 burning sensation second dose: past due; burning sensation on the left side of her chest and chest pain; rapid heart b... Read more
second dose: past due; burning sensation on the left side of her chest and chest pain; rapid heart beat; dizziness; chest pain; This is a spontaneous report from a Pfizer-sponsored program a contactable consumer reported (patient). A 45-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: unspecified), dose 1 via an unspecified route of administration, in the left arm, on 12Apr2021, as single for COVID-19 immunization in ambulance center. The patient's medical history and concomitant medications were not provided. The patient's family history included hypertension. No previous immunization with the Pfizer vaccine was given. The patient was not immunized in a long time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021, immediately after receiving the vaccine, the patient experienced, burning sensation on the left side of her chest and chest pain, rapid heartbeat, dizziness and second dose was past due. No additional vaccines administered on same day. The patient did not visit to emergency room or physician Office. They told her to wait another 15 minutes. Caller received her first Pfizer Covid 19 Vaccine on 12April2021. Immediately after receiving the vaccine caller experienced a rapid heartbeat, dizziness, burning sensation on the left side of her chest and chest pain. Symptoms went away within 30-40 minutes. Caller questioned if she should receive the second Pfizer Covid 19 Vaccine. Got response. From the attached document no info under side effects/adverse reaction in reference to the chest pain & burning in the chest. Under who should not get the PFIZER-BIONTECH COVID-19 VACCINE and get response like you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of this vaccine had a severe allergic reaction to any ingredient of this vaccine. Caller stated she believed she got the vaccine on 12Apr2021, but she was not sure. She no longer has the vaccine card with her to verify the vaccine date at this time. Caller states she was past due, she had something come up and couldn't get the second dose. She was scheduled to get the second one coming Thursday, on 27May2021. She was due two or three weeks ago for the second one, so she was past due. It was in April that she got the first dose. She was supposed to get the second one the Friday before a holiday. Caller clarified her reaction to the Pfizer Covid-19 Vaccine as rapid heartbeat, some pain in chest and some burning. It was given in the left arm the burning stemmed from that side only. Also had a little dizziness. Her reactions started a couple minutes after receiving the vaccine and went away within thirty to forty minutes. No relevant tests were done. The outcome of the event second dose: past due was unknown and recovered for other events on 12Apr2021. Information about batch/Lot number has been requested.
45 2021-06-01 electric shock sensation, pain in extremity Day of pain in arm Day2-5 pain in arm like a nail was hammered in it and someone punched my shoulde... Read more
Day of pain in arm Day2-5 pain in arm like a nail was hammered in it and someone punched my shoulder, sleepy a day Day 6- rash on neck- went away one day Day 7-woke up to level 8-10 level in my hips, lower back, pelvis, tailbone, back and side of top left leg, I had mild moderate pain level 4-5 in that area before the shot and after vaccine extreme constant pain like the pain I had in those areas 3 years ago when hit in my car by semi. The pain had been calmer for 3 years but after the vaccine it is level 9-10 pain especially at night and has not gotten better it?s been 2 months. The new symptoms never had are at night have shock like electric pain in diff spots in that area keeping me up most the night. Also the side of my left leg hadn?t heard or the tightness in back top left leg.
45 2021-06-01 tingling Neurological: tingling in arms, legs, face, tongue. Effects still persist and have not subsided (12 ... Read more
Neurological: tingling in arms, legs, face, tongue. Effects still persist and have not subsided (12 days later so far) General: Low grade fever 100.1 within 24 hours lasting no more than 4 hours, mild joint pain
45 2021-06-03 facial paralysis, numbness, feeling of insects crawling on skin lost complete feeling in on the right side of her face, including her ear and inside of mouth; Shing... Read more
lost complete feeling in on the right side of her face, including her ear and inside of mouth; Shingles; woke up in the middle of the night; Numbness; severe headaches; creepy crawly feeling under her skin on the top right side of her head; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left Upper on 02May2021 (Lot Number: EW0182) as 2ND DOSE, SINGLE for covid-19 immunisation; apremilast (OTEZLA), oral from an unspecified date (Lot Number: F2671A; Expiration Date: May2023), at 30 mg 2x/day for psoriatic arthropathy; prednisone, oral from an unspecified date (Batch/Lot number was not reported), at 7 mg, 1x/day for psoriatic arthropathy. Vaccination Facility Type: Pharmacy/Drug Store. Vaccine Administered at Military Facility: No. Medical history included allergy alert test negative, immunology test, respiratory distress, cytogenetic abnormality, endocrine test abnormal, diabetes mellitus, obesity, psoriatic arthropathy. Had no other vaccines the same day and no problems with vaccines in the past. The patient previously received the first dose of bnt162b2 (lot number EN6205) on 04Apr2021 at left upper arm for covid-19 immunisation without adverse event. The patient's concomitant medications were not reported. The patient was seen at the emergency room last Thursday and was diagnosed and began treatment for shingles (on 20May2021). She had lost complete feeling in on the right side of her face, including her ear and inside of mouth. It really started on the 8th or 9th of May with a severe headache that she ignored for about a week. The headaches were debilitating and she didn't got to the emergency room until she lost feeling. Before the lost feeling she had the creepy crawly feeling under her skin on the top right side of her head (from May2021) and then had the headaches that were so severe they woke her up from dead out of her sleep. Wednesday, 19May2021 she woke up in the middle of the night from the debilitating pain from the headaches out of her sleep. Then she went to the emergency room the 20th since at that point she lost complete feeling. She is being treated with medication, a broad spectrum antiviral, which is no fun, but it's working. Although it's not completely gone, it is better than it was, in terms of the numbness (from May2021). Was given generic Valtrex, valacyclovir hcl 1 gram to take three times daily. Mentions she had to stop her other medicines for to her underlying condition, Psoriatic arthritis, a rheumatoid condition, which is why she is reporting this. She has had this for 23 years. She had to stop the Otezla and Prednisone she takes concurrently when she got the vaccine. Told she can't take theses with the antivirals, so she is screwed right now. Was supposed to start on Xeljanz, but was told not to until after she got the vaccine, but then after the Covid shots she got the shingles then they told her not to start the Xeljanz until after the shingles. Later mentions she takes other medication for psoriatic arthritis and the doctor did do testing to rule out other issues and check her kidney functions since she is on an antiviral, more labs, a CT scan with contrast to rule out acute stroke. Her kidneys are fine and there were no issues in the veins or arteries of her brain. The events require a visit to Emergency Room. The outcome of Facial paralysis, Shingles and Numbness was not recovered. The outcome of others was unknown.
45 2021-06-03 hot flush 10:30 am--15 after receiving vaccine, patient described feeling dizzy and having a hot flash. Patie... Read more
10:30 am--15 after receiving vaccine, patient described feeling dizzy and having a hot flash. Patient was taken to a clinic room, provided water and observed by nursing staff, vital signs BP 100/67, P. 68, R. 17, lung sounds clear bilaterally, patient alert. At 10:50 patient stated she "felt like something is in my throat" and was trying to clear her throat. At 10:51 Epinephrine 1:1000 0.3mg injected in right upper thigh per epi injector, 10:52 am O2 started at 15L via rebreather mask and EMS called. At 10:53 BP 130/90, P 80, R 20, lung sounds clear bilaterally, patient alert. At 10:57 am BP 132/92 patient alert. At 10:57 EMS arrived, care of patient transferred to EMT/Paramedic. Patient transferred to hospital via ambulance.
45 2021-06-03 pain in extremity headache pain in hip and legs pain from the waist down back pain Miscarriage (7 weeks 5-6 days preg... Read more
headache pain in hip and legs pain from the waist down back pain Miscarriage (7 weeks 5-6 days pregnant) went to OB clinic Ultrasound no heartbeat 7 weeks 5-6 days Determined that the baby stop growing at 7 weeks and 5 days, which is the day I received my 2 dose of my vaccine. Friday, May 21st suggested doing a DNC of getting medication to induce at home 24th gave medication to induce problems that 28 having alot of pain miscarriage was not complete told to do another dose of medication to induce at home last week on tuesday and the miscarrige is still not complete advise to surgery of anotehr dose of medication go back next week .misscariage is not complete.
45 2021-06-03 tingling, involuntary muscle movements, numbness It started with body ache, fever, chills and dizziness. Patient went to ER where she was given Tora... Read more
It started with body ache, fever, chills and dizziness. Patient went to ER where she was given Toradol y Relafen. Se continued to feel dizzies and headaches started for a whole week. Then she began to have involuntary movements of the left hand and her mouth twisted to the left. Eventually the symptoms subsided but she started to feel numbness of the fingers and tingling on the neck . She went back to the ER and was given Pepcid, antibiotics and a COVID-19 test (PCR) which result was negative (04/18/2021). The symptoms persisted so she visited an ER again where a CT was performed and results were normal. Her primary physician gave a referral to the an ER of a healthcare facility where a contrast CT was performed and was given Vistaril and Morphine. In this last ER visits she started to tremble. The results of this last test and lab results were normal. She finally was referred to a neurologist who gave klonopin and is pending further tests.
45 2021-06-05 burning sensation Wednesday, I fell asleep soon after I got home. I had a couple of hours of extremely deep sleep. (In... Read more
Wednesday, I fell asleep soon after I got home. I had a couple of hours of extremely deep sleep. (In retrospect, this makes perfect sense because neurological stress does that to me.) When I was waking up, I realized that I had the sensation of hot. I didn't have a fever or a sunburn. Nonetheless, the nerves near the skin for much of my arms, legs, and part of my torso were saying, 'Hot'. They were all normal body temp when I checked with my hand. On Thursday, the sense of 'hot' continued. The sensation was morphing from 'hot' to the sore feeling one gets from a sunburn. The truth didn't match the sensation. There is no skin damage. Touching it does not aggravate the soreness. As I type on Sunday, my inner thighs have a slightly lesser version of both 'hot' and sore. This is also true of my arms, rest of my legs, and other parts of my body to a lesser extent. In light of health issues noted above... The sensations were the same between right and left. My glucose was normal a couple hours before the shot and when I checked soon after waking.
45 2021-06-05 feeling hot Patient received Pfizer vaccine at 10:25am. At 10:35am, her husband alerted the pharmacy staff that ... Read more
Patient received Pfizer vaccine at 10:25am. At 10:35am, her husband alerted the pharmacy staff that she said she was feeling dizzy. The pharmacist went out to assist and the patient stated that she was dizzy, nauseated, and felt hot/sweaty. The pharmacist prepared a cold pack for the patient and had the daughter hold it on the back of the patient's neck while holding her hair up. Checked blood pressure at 10:40am and it was 107/74, so no concerns of high or low bp. By 10:45am the patient stated that the dizziness was gone, but she still just felt hot as if she had "been in the sun too long". At 10:55am the patient said she felt better and was comfortable going home at that point. The husband and daughter took her home.
45 2021-06-06 difficulty speaking During our event today, here at the Church in coordination with the Cleaning Services monthly train... Read more
During our event today, here at the Church in coordination with the Cleaning Services monthly training event, a patient had an anaphylactic reaction to the COVID vaccine. Anaphylaxis: 45yoF w/ h/o Rheumatoid arthritis and Wegener?s granulomatosis who takes immunosuppressive infusion 2x/yr, most recently in April, no h/o anxiety, and h/o COVID x2 (4/2020 & 10/2020), experienced an anaphylactic reaction, with symptom onset beginning within 1 min of us administering a 1st dose of the Pfizer-BioNTech COVID vaccine. Sx: throat clearing, cough, chest tightness, diaphoresis PEx: Alert throughout Hand over chest/ lower throat Shortness of breath Voice hoarse, speaking in 1-2 word sentence fragments Timeline: 10:35 - administered 10:36 - throat clearing 10:37 - advising pt to sign up for V-safe given her underlying autoimmune dz 10:38 - intermittent coughs 10:41 - drawing up epi 10:45 - Epi 0.5ml (1mg/ml) administered IM 10:46 - Called 911 for EMS 10:50 - Epi 0.5ml (1mg/ml) administered IM 10:55 - Diphenhydramine 50mg IM 10:57 - Pt notes throat feels more released from prior tightness 11:01 - EMS arrived, began evaluating patient 11:25 - Patient walked out to car, sister drove her home. Advised sister for her or their dad (at home) to stay with/watch the patient for at least the next 3 hours, to be sure angioedema does not worsen; I?m happy to giver pt her 2nd dose on the return date, but recommend if she gets it, best to get while in a hospital setting; to discuss whether or not to get 2nd dose with her Rheumatologist, especially given her prior COVID illnesses x2, making this her immune system?s 3rd exposure; consider getting Epi pen to carry with her for future. Following up with pt to advise her against getting an mRNA vaccine in the future, that currently the only other option in the U.S. is the Janssen/J&J vaccine, and that given her autoimmune disease, I would be concerned about her developing immune thrombosis and thrombocytopenia, so recommend she discuss with her rheumatologist, and that if she gets a subsequent dose of any COVID vaccine, to have it administered at a hospital location.
45 2021-06-06 feeling hot Within 10 minutes of receiving the vaccination in my left arm, I began feeling heat in my face. I l... Read more
Within 10 minutes of receiving the vaccination in my left arm, I began feeling heat in my face. I looked at my Fitbit to check my heart rate, which is normally in the high 70's or low 80's and it had exceeded 130. I felt an itchiness in my neck and face, which was confirmed by the RN on duty that my face, neck and chest were red. I was given 2 chewable Benadryl tablets, and observed for an additional 30 minutes, at which I was released from the facility.
45 2021-06-06 numbness, tingling +- 30 minutes after the shot I felt very woozy and my vision became impaired. Since then I have ongo... Read more
+- 30 minutes after the shot I felt very woozy and my vision became impaired. Since then I have ongoing intermittent numbness/tingling/itching/inflamation in face/head/arms/mid-spine, a drooping right eye, headaches/pressure, blurry/impaired vision, light sensitive eyes (feels like theres sand in them) and dizzy spells. At Urgent Care the doctor diagnosed me with "Facial Paresthesia and adverse effects of vaccine." He sent me to the ER where blood clots/stroke was ruled out. They referred me to a neurologist for next week Friday. I also had a few days of excessive thirst, unusually heavy menstrual cycle and a week of a pain above my right elbow. My symptoms have persisted for 11 days and counting.
45 2021-06-06 migraine Ongoing migraine headaches that are not relieved. Loss of peripheral vision in left eye. Constant ea... Read more
Ongoing migraine headaches that are not relieved. Loss of peripheral vision in left eye. Constant ear ringing. Blood clot in right arm. Ongoing dizziness and vertigo. Possible intracranial hypertension. I am being tested next week. These symptoms have been ongoing and have not been relieved. I was given Eliquis for the blood clot, which I no longer take. I take Trokendi 100 mg daily which is being increased for the migraine. I am also suffering with chronic fatigue.
45 2021-06-06 pain in extremity Patient said after getting the vaccine her arm has had constant pain in it. Has been experiencing pa... Read more
Patient said after getting the vaccine her arm has had constant pain in it. Has been experiencing pain currently. Patient felt that the immunization was given too high.
45 2021-06-07 numbness, migraine Migraine headache; Face went numb; Hands turned red; Heart raced; This is a spontaneous report from ... Read more
Migraine headache; Face went numb; Hands turned red; Heart raced; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 05Mar2021 12:15 (at the age of 45 years old) as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took azithromycin (ZITHROMAX) and, cefdinir (OMNICEF) and experienced allergies. The patient has no COVID history prior vaccination. The patient was not COVID tested post vaccination. On 05Mar2021 12:45, the patient's face went numb, hands turned red, heart raced, and had migraine headache progressively getting worse for four (4) days. The patient had to go to hospital for headache on 4th day, she has got treatment and her headache went away. It was also reported that she woke up on 5th day and her headache came back. The only persistent symptom is headache. The adverse events resulted in Emergency room/department or urgent care visit. The event migraine headache was treated with cocktail IV and CT scan was referred. The patient has not recovered from the event migraine headache, and was recovering from other events. No follow-up attempts are possible. No further information is expected.
45 2021-06-07 migraine Migraine; This is a spontaneous report from a contactable consumer (patient). A 45-years-old, non-pr... Read more
Migraine; This is a spontaneous report from a contactable consumer (patient). A 45-years-old, non-pregnant, female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in a Pharmacy or Drug Store, administered via an unspecified route in right arm on 06Mar2021 15:30, at 45 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included ibuprofen and naproxen sodium (ALEVE), both taken for an unspecified indication, since an unknown date. The patient previously took amoxicillin and experienced drug hypersensitivity. On 07Mar2021 06:00 AM the patient experienced migraine. She didn't receive any treatment. At the time of the report the reported event was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-06-07 pain in extremity Parents and purple lips; Bad pain in vaccinated arm (sore to touch, hurts to move arm, cannot raise ... Read more
Parents and purple lips; Bad pain in vaccinated arm (sore to touch, hurts to move arm, cannot raise arm over head); Bad pain in vaccinated arm (sore to touch, hurts to move arm, cannot raise arm over head); This is a spontaneous report received from a non-contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 45-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 16Mar2021, at 13:30, as single dose for covid-19 immunization when the patient was 45-years-old. The patient medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. There were no concomitant medications. In Mar2021, a patient experienced parents and purple lips and bad pain in vaccinated arm (sore to touch, hurts to move arm, cannot raise arm over head) on an unspecified date. No treatment was given for the events. The outcome of events was unknown.
45 2021-06-07 speech disorder I felt a sudden surge of tightness in my throat muscles about 45 minutes post shot. Then, my throat ... Read more
I felt a sudden surge of tightness in my throat muscles about 45 minutes post shot. Then, my throat began to tighten, and I could not speak without coughing. I could only manage whispers.; I could not speak without coughing; I could not speak without coughing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EN6198), via an unspecified route of administration, administered in arm left on 04Mar2021 17:15 (at the age of 45-year-old), at a 1st dose, single dose for covid-19 immunisation. Medical history included patient was allergic to Sulfa, penicillin, tramadol, compazine, Levaquin. No other medical history was reported. Concomitant medications included desvenlafaxine succinate (PRISTIQ); buspirone hydrochloride (BUSPAR); bupropion hydrochloride (WELLBUTRIN); gabapentin (GABAPENTIN); topiramate (TOPAMAX). Patient did not had other vaccine in four weeks, patient did not had covid prior vaccination and patient has not covid tested post vaccination. On 04Mar2021 17:45 the patient experienced I felt a sudden surge of tightness in my throat muscles about 45 minutes post shot. Then, my throat began to tighten, and I could not speak without coughing. I could only manage whispers. Adverse events resulted in emergency room visit. Therapeutic measures were taken as a result of I felt a sudden surge of tightness in my throat muscles about 45 minutes post shot. Then, my throat began to tighten, and I could not speak without coughing. I could only manage whispers. Patient was treated with Steroid, benedryl, and Pepcid injections. Outcome of the events was resolved with sequel on an unspecified date in 2021. No follow up attempts are possible. No further information is expected.
45 2021-06-08 pain in extremity Severe reaction lasted 8 days. This is day 9 and still in pain, but not as bad. Wrote doctor msg t... Read more
Severe reaction lasted 8 days. This is day 9 and still in pain, but not as bad. Wrote doctor msg twice, on day 3 and 8. Symptoms started when I laid down that night. Extreme pain in arm and entire abdominal wall. Lasted into next day and could not get out of bed. Day 3 muscles were still like rigor mortis. No stretching, magnesium, or Epsom salts helped. Upper back went out. Day 4-now, lower back went out. Can not sit, stand, lay down, get up with out extreme pain. Trouble walking/ stiff. Exhausted.
45 2021-06-08 tingling neurological side effects; Paresthesia, the tingling in the legs and in arms and the tongue, both le... Read more
neurological side effects; Paresthesia, the tingling in the legs and in arms and the tongue, both leg, both arms and the tongue; Paresthesia, the tingling in the legs and in arms and the tongue, both leg, both arms and the tongue; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), dose 2 via intramuscular route, administered in left arm on 21May2021 15:30 as SINGLE DOSE for covid-19 immunisation. The patient had no medical history and concomitant medications. Patient previously received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0172 and Expiration date: unknown), dose 1 via intramuscular route, administered in left arm on 30Apr2021 15:30 as single dose for covid-19 immunisation. Patient has not received any other vaccine 4 weeks prior to COVID-19 vaccine. In May2021 (within 24 hours after second shot), the patient reported that she was going to ER (today as reported) to see neurologist because she experienced neurological side effects, paresthesia, the tingling in the legs and in arms and the tongue, both legs, both arms and the tongue. The patient underwent lab tests and procedures which included blood work with unknown results on an unknown date. Outcome of events was unknown.
45 2021-06-09 electric shock sensation, tremor I sat for 15mins after getting my shot , I had blurred vision after about 10 minuteses and I felt ok... Read more
I sat for 15mins after getting my shot , I had blurred vision after about 10 minuteses and I felt ok but I was a little lightheaded. I assumed it may have been because I hadn't eaten. I got in the car and headed home we did do some shopping prior to heading home. .At that time my heart started racing I had tremors that felt like electrical pulses going through my arm we turned around and went back to CVS because the nearest hospital was too far we were just up the road from the CVS. I looked at the clock around 3:35pm and questioned whether I had waited long enough before leaving the vaccine site I was worried about anaphylactic shock at that time. I was feeling so bad when we arrived that I didn't know if I could walk the feeling shot from my arm to my abdomen and continued down my legs into my. I was advised to put my legs up I had to make myself breathe or I would have stopped breathing. It lasted for about 15 minutes and I was able to drink water after about 5 minutes . A nurse on duty sat with me and they told me to check with my doctor before getting the 2nd dose. Around 11pm that night, it started again I went to the ER at Hospital and they did an EKG and blood work to check for an allergic reaction and monitored me for about 4 hours and I was told everything was fine.
45 2021-06-09 feeling hot, weakness I started feeling bad on Monday night. I rested on Tuesday. By Tuesday night, I tried to get up, fel... Read more
I started feeling bad on Monday night. I rested on Tuesday. By Tuesday night, I tried to get up, felt hot and faint, and nearly passed out in my bedroom. I did fall down and hyperextended my knee and scraoed my feet, so now I can hardly walk. Thankfully, my boyfriend ran in the room and grabbed me. I got up again to go to the bathroom and felt hot and faint, so I put a cold washcloth on my head and laid in the bathroom. I stopped taking Tylenol, but I am still feeling weak, faint, and dizzy nearly 72 hours later. I've tried to walk around a little bit, but I'm still feeling like I could faint - weak, off, dizzy. I've tried to rest and drink lots of fluids. Frankly, I'm scared of how I feel.
45 2021-06-09 numbness, tingling PVCs; junctional rhythm; irregular heartbeat/ mix of normal rhythm along with PVCs; hypoxia/ pulse o... Read more
PVCs; junctional rhythm; irregular heartbeat/ mix of normal rhythm along with PVCs; hypoxia/ pulse ox was 80; blue lips; near syncope; feeling of being unwell; lightheadedness; tingling and numbness from mid-calf down to feet; tingling and numbness from mid-calf down to feet; sudden and intense sensation of GI distress; severe outbreak of intense sweating on forehead and back of neck; bradycardia/ low heart rate/ HR was 49/ HR was 40/ HR was 35; bruising; swelling at injection site; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Apr2021 15:00 (Batch/Lot Number: ER8731) at the age of 45 years old as 1st dose, single dose for COVID-19 immunization. Medical history included allergic to scallions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (medications the patient received within 2 weeks of vaccination) included possible dose or two of either ibuprofen (ADVIL) and paracetamol (TYLENOL), taken for unspecified indication, start and stop date not reported. COVID-19 vaccine was administered in the hospital. On 18Apr2021 (7-8 minutes after shot), the patient experienced sudden and intense sensation of gastrointestinal (GI) distress, overtaken by severe outbreak of intense sweating on forehead and back of neck. Alerted the staff member who took blood pressure and heart rate. Staff member said blood pressure was perfect, heart rate (HR) was 49. The patient stayed an extra 15 minutes. At the end of that period, blood pressure was 121/81 and HR was 40. On Days 2 to 7 (Apr2021), no symptoms other than bruising and swelling at injection site. On 26Apr2021 (Day 8) around 11:00, the patient was near syncope; there was sudden, intense feeling of being unwell and lightheadedness (was sitting at computer desk). Checked vitals. HR was 35, and pulse ox was 80 on home pulse oximeter device. Also experienced hypoxia, blue lips, tingling and numbness from mid-calf down to feet. On 27Apr2021 (Day 9), the physician confirmed irregular heartbeat, low heart rate and ordered heart monitor and bloodwork. On 03May2021 (Day 15), heart monitor results: mix of normal rhythm along with premature ventricular contractions (PVCs), bradycardia, and junctional rhythm. Since the vaccination, the patient been tested for COVID-19 with polymerase chain reaction (PCR): negative (Nasal Swab) on 01May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included physician and cardiologist visit and echocardiogram. Therapeutic measures were taken as a result of the events. Outcome of the events were recovered with sequelae. Additional information about batch/lot number has been requested.
45 2021-06-09 numbness, tingling I had severe chills body aches and nausea for about a day and a half and I felt really lethargic. S... Read more
I had severe chills body aches and nausea for about a day and a half and I felt really lethargic. Symptoms started to dissolve on day 2. Day 3, I started feeling numbness and tingling in both arms and my tongue. I had a little chest discomfort and felt like I was about to have a heart attack. I went to an Express Care for treatment because I felt like I could not make it to the Emergency Room.
45 2021-06-09 pain in extremity Arm hurt; This is a spontaneous report from a contactable consumer. This 45-year-old female consumer... Read more
Arm hurt; This is a spontaneous report from a contactable consumer. This 45-year-old female consumer (patient) reported that after taking first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9265; Expiration Date: May2021) via an unspecified route of administration and administered in left arm on 02Feb2021 as single dose for COVID-19 immunization. The patients medical history include asthma is allergy induced. States she has a sulfa allergy, so she doesnt even have an inhaler, so she just avoids all of her allergens. Nerve pain States she avoids allergens, but can't avoid maple trees, or cottonwoods. Caller states she is pretty much allergic to everything but cats and dogs. Had surgery on her heart for WPW syndrome. she had shingles in Jan2020 not in Feb2020, says she isn't sure how long it stays in your system. Hypersensitivity, herpes zoster and wolff-parkinson-white syndrome. The patients concomitant medications include medroxyprogesterone acetate (DEPO-PROVERA) she has been taking this medication for 17 years and will be 18 years in Jul 2021, she is horrible with remembering stuff, says she keeps pills in pill organizer, and her prescriptions in a pencil case, duloxetine hydrochloride (CYMBALTA) she has been taking this about a year and a half and zolpidem tartrate (AMBIEN) says she started taking this medication within the year for indication to fall asleep. The patient previously took sulfa [sulfadiazine], influenza vaccine for hypersensitivity. She had her two doses of the Pfizer vaccine in February, the last dose being 23 Feb 2021. She got every side effect known to man the next day. Caller says they all went away within the first 24 hours. However, 48 hours later, she started having a high heart rate. She went to the emergency room on 23Mar2021 with a 124 resting heart rate. The highest her heart rate has been is 183. She is on heart medication and her heart rate is currently 113, and she is just laying in bed. Three days after her vaccine, clarified as 26 Feb 2021, her heart rate was 111. She was short of breath that day but couldn't figure out why. She felt her heart was racing and luckily she has an apple watch that does an EKG, so she has been monitoring this. She is allergic to the flu shot so she was hesitant about getting the COVID vaccine. However, work was offering it for free so that is why she did it. She visited the emergency room on 23Mar2021. She was taking it easy, talking to her doctor and he said not to do runs, says she used to do 5ks, but she hasn't run since Oct 2020. She had been taking it easy. She has asthma and on 23 Mar 2021, she just couldn't get a breath in and her heart rate was high at the time. Even before she went to the emergency room, her heart rate was at 150, so she drove herself to the emergency room at 2am, and that's when she was referred to her electro cardiologist, and he has been treating the caller since. on the day of the shot, 8 hours later, she couldn't eat, she couldn't sleep, she had a severe headache- like her head was being crushed in. She had a 102 fever and had body aches. She had it all. These began on the day of the second shot. Caller states everything was gone by Thursday, 25Feb2021. She clarifies she received her shot-on Tuesday, 23 Feb 2021, the side effects happened all night long and the next day. She went to bed at 8am on Wednesday. She slept all day Wednesday. Confirmed with caller that she has recovered completely from these side effects. After the first dose, her arm just hurt, says that she has recovered completely from her arm hurting. High heart rate: She confirms this is still ongoing. her doctor got her on 360mg of Cardizem for it. With this medication, her heart rate is currently 111. The resting heart rate is supposed to be 50-90. Caller states her high heart rate is slightly improving. Her heart rate was running around 150 to 183 before her doctor placed on her on the medication. She states the high heart rate is not going away, and she may have to be on meds for rest of her life. Short of breath: Caller states the high heart rate alerted her to her shortness of breath, says she felt like she ran a couple of miles. The doctor told her it was like her heart was running a marathon without her. The shortness of breath has improved and is currently very, very slight. If she starts moving around too much, she starts getting wheezy. to get her vaccine record card that she has to get up or she freezes up. She was taking melatonin and Tylenol PM. This had been going on for 10 years and when her doctor found out he said to her how are you not dead? She was taking 12mg of melatonin with a capsule of magnesium to process it, two Tylenol PMs and a muscle relaxer just to fall asleep. says the magnesium is what processes the melatonin, just to make it go faster. says this was about 7 to 8 months ago. she had the flu for three weeks, was tested for COVID three times, but it was not COVID. She was not sleeping, even just lying-in bed, so this is why the doctor prescribed it. The patient underwent lab tests and procedures which included blood culture: cardiac stress test, computerized tomogram, electrocardiogram, laboratory test: she has been tested for that multiple times in 2010, x-ray. The outcome of event was recovered n an unspecified date 2021. Product Complaint 1: Description of complaint: Caller states she was taking 12mg of melatonin with a magnesium capsule, two Tylenol PMs, and a muscle relaxer. She was taking melatonin and Tylenol PM, and nothing worked. Caller states once she's asleep she is fine, says this has been for about 10 years. She can't fall asleep without the Ambien (Zolpidem). Caller says the magnesium is what processes the melatonin, just to make it go faster. Caller states she does not know the NDC/LOT/EXP for any of these products mentioned, says this was about 7 to 8 months ago. Product Complaint 2:Caller states her doctor got her on 360mg of Cardizem for it. With this medication, her heart rate is currently 111. The resting heart rate is supposed to be 50-90. Caller states the high heart rate is slightly improving. She was running from 150 to 183 before her doctor placed on her on the medication. She states the high heart rate is not going away, Product Complaint 3: Description of complaint: With the flu shot she had the flu for 5 months, and her doctor said she can't get the flu shot ever again. No further details provided.
45 2021-06-10 bell's palsy, muscle twitching I guess it was like bell's palsy and I had it happened to me three times, two times in one day and t... Read more
I guess it was like bell's palsy and I had it happened to me three times, two times in one day and then one time like a couple days later; Mouth twisting; Eye closing; This is a spontaneous report from a contactable consumer or other non hcp reported herself. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 14:15 (Batch/Lot Number: EW0185) as a Single dose for covid-19 immunization. The patient past Medical history included asthma. The concomitant medication was reported as no. the patients historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 29Apr2021 (Batch/Lot Number: EW0167) as a Single dose for covid-19 immunization. The patient was not administered another vaccine within 4weeks prior. On 26May2021, after the second dose of her vaccine the patient experienced side effect of the mouth twisting, eye closing and she couldn't like, she guesses it was like bell's palsy and she had it happened to her three times at 5:30 in the morning and then again at 8:45 when she went to work and then she had to go to the emergency on the Wednesday and then again on the 28th in the morning at about 6 O'clock in one day and then one time like a couple days later. The patient confirmed went to emergency, stated, "she called the advice nurse and they said nothing was going on like when they did there, but she had her, when she was at work, she had people who seen it happening to her. So that was a good thing because as it met, she doesn't think that people would believe that it happened to her and she didn't want to take the shot just because of the side effects. But due to her job policy that we had to take it, so that's why she took it to keep her job. Consumer stated, "No, they didn't do anything for me.". The outcome is Recovered on an Unspecified date in 2021.
45 2021-06-10 muscle spasms Intense contractions level cramping and back pain. Including, but not limited to ovulation and mense... Read more
Intense contractions level cramping and back pain. Including, but not limited to ovulation and menses. Attributed to previously completely asymptomatic adenomyosis. Disabling cramping and back pain continued intermittently more days than not for over 2- 2.5 months.
45 2021-06-10 pain in extremity Started getting pain in my right leg on May 1st, seen my Family Dr. on 4/29/21 clean bill of health.... Read more
Started getting pain in my right leg on May 1st, seen my Family Dr. on 4/29/21 clean bill of health. Pain wouldn?t go away was going to my chiropractor the whole month of May 2 times a week, for my right leg, I favored that leg never missing work, I?m a childcare provider. On 31May2021 the pain went down my leg and behind my knee just throbbing, I was walking up steps and a loud snap happens in my leg dropped me right there couldn?t move. Was taken to the ER, where they found a blood clot in my leg which caused pressure to build up on my knee which ruptured my meniscus, damaged joints, and cartilage in my knee. They put me on blood thinners, have to have surgery and can?t for 3 months I have to be off blood thinners. Can?t work and was forced to close my daycare business of 18 yrs and sell everything due to this injury. My Dr has linked it to the vaccine my blood wok showed high levels of hormones. Never ever had an issue until I got second shot. So now I?m trying to get disability, not looking good due to me being self employed. So who is gonna step up and help me financially, I was open threw the whole pandemic and this is how I go out of Business! Devastating to say the least?. My Community is shook up over this, so I took one for the team my family refuses to get the vaccine and others have decided NO after hearing my story.
45 2021-06-10 tingling Radiculopathy that begin 4 days aftr shot #1 in left arm as a tingling in full hand that rushed up t... Read more
Radiculopathy that begin 4 days aftr shot #1 in left arm as a tingling in full hand that rushed up the arm. Next day same thing happened in left leg (began at toes and rushed up leg). Then the right leg. Then the right arm. (So all 4 extremities buzzing pins and needles at once.) Never experienced this before. Left side was the worst. The right side resolved after a few weeks. Left arm persists significantly to this day. Also no menstruation for 3 months ( had been very regular previously.) After shot 2 this didn't change, there was just the few days of headache and muscle aches.
45 2021-06-10 seizure R56.9 - Seizure (CMS/HCC)
45 2021-06-11 tingling on 5/18/21 five minutes after first vaccination tongue warming sensation & couldn't move arm for 2 ... Read more
on 5/18/21 five minutes after first vaccination tongue warming sensation & couldn't move arm for 2 days on 6/8/21 received second dose at 6pm and by 9pm mouth, cheeks, and throat tingling and weird, sweet taste in mouth for one hour (patient did not inform vaccinator about side effects when coming for second dose)
45 2021-06-12 feeling cold, tremor Upon immediate injection. I started to shudder, tremble and was freezing cold and my BP spiked to 17... Read more
Upon immediate injection. I started to shudder, tremble and was freezing cold and my BP spiked to 177/104 at highest. Took a full 12 hours to normalize BP. HR was totally normal. But BP was still in 160?s after 2 hours.
45 2021-06-13 muscle spasms, bell's palsy, facial paralysis, seizure, muscle twitching I got the 2nd dose, I went and sat down my heart was racing and I was breathing funny. The side were... Read more
I got the 2nd dose, I went and sat down my heart was racing and I was breathing funny. The side were I got the shot my muscles felt like it was moving and my face started to droop and was swelling. The rushed me to the er and they gave me an cocktail for my reaction and they said that I passed out. It was like I went to sleep and and woke up with a disability. I have muscle spams in my face, I could feed myself my daughter had to feed me. They told me that it was bells palsy. they gave me pretonze and stomach meds to treat it. They told me they wouldn't take my case since the vaccine was voluntary. They gave me muscles relaxer but it was messing with my heart. It took me until march till I was normal but I still have the fast blinking and lock in my mouth . I also had a seizure a month later.
45 2021-06-13 tingling I experienced muscle weakness and tingling in my legs. I went to the ER and was given medication. Th... Read more
I experienced muscle weakness and tingling in my legs. I went to the ER and was given medication. The Toradol and the narcotic did not help. But the Gabapentin medication did provide relief.
45 2021-06-14 cold sweat, flushing spike on her blood pressure for the past 2 days reaching a maximum of 205/125; fever later on the ev... Read more
spike on her blood pressure for the past 2 days reaching a maximum of 205/125; fever later on the evening and the whole next day reaching 100.1F; body aches; chills; wakes up in the evening with a cold sweat; face was flushing bright red and goes away after a while; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EW0182, Expiration date: Unknown), via an unspecified route on 02Jun2021 as a single dose for covid-19 immunization. Medical history included hypertension for which she has taken intracranial hypertension medication Diamox, 250mg, twice a day for over a year now to lower her blood pressure, tubal ligation in 2015 and since then she is on a low dose birth control because she was suffering from migraines in the past and was getting shots and then was taken off of that and put on hormonal continuous treatment. She now has no periods and doesn't suffer from migraines. Also, she has COVID back in Mar2021 and had a severe case. The patient concomitant medications were not reported. On 02Jun2021, patient experienced a fever later on the evening and the whole next day reaching 100.1F (03Jun2021), she complained about body aches and for the next 2 days up until today she experienced chills and wakes up in the evening with a cold sweat ("clothing are wet because of the sweat") and the chills are also experienced during daytime (ongoing), her face was flushing bright red and goes away after a while. She knows for a fact that this is not hormonal because she is on a low dose birth control pill since she had a tubal ligation in 2015. So, she knows it is not pre- menstrual. She has had a spike in her blood pressure within the last 2 days with the highest reached being 205/125 (ongoing). She said her main concern was with the hypertension and she figured that all of her other side effects were normal, but it made her nervous with her hypertension and how her blood pressure shot up so high because her medication keep her blood pressure normal and it has never gone above normal on this medication other than two days ago when she had the spike and it has been high since then. She has been trying to keep it down and her diastolic keeps going above 90 and her doctor wants her below that. She has been trying to get in touch with the neurologist who prescribed her that medication and he is usually very busy. She has been on her medication for intracranial hypertension for over a year now and confirmed that she wasn't started on it due to the side effects from the COVID vaccine. The patient underwent lab test and procedure which included body temperature reading of 100.1F on 03Jun2021 and blood pressure measurement of 205/125. Patient wanted to know if the adverse events that she experienced are included in the most commonly reported AEs after getting the Pfizer BioNTech Covid-19 Vaccine shot, how long the adverse events usually last after getting the first dose and if the side effects that she experienced after getting the first shot would be a contraindication in getting the 2nd dose of the vaccine. The clinical outcome of the event her blood pressure keeps going up down to today, she does not have a fever anymore, but she is still getting chills and she feels like she gets flushing in her cheeks throughout the nighttime but she is still going on with no fever. One night she may wake up with sweats and another night she wont, and outcome of body ache was unknown. Follow-up (10Jun2021): New information received from a same contactable 45-year-old female consumer (patient) included: events information updated, date for had ran a fever of 101 degrees updated, lot number updated, treatment taken as a result of events updated, medical history added, and clinical outcome of the events updated. No follow-up attempts are possible. No further information is expected.
45 2021-06-15 hot flush Increased Blood pressure and heart rate. Hot flashes moving throughout the body.
45 2021-06-15 pain in extremity PALPITATIONS, TACHYCARDIA FROM 120S TO 130, SHORTNESS OF BREATH, FATIGUE, RIGHT ARM PAIN. OCCURS MUL... Read more
PALPITATIONS, TACHYCARDIA FROM 120S TO 130, SHORTNESS OF BREATH, FATIGUE, RIGHT ARM PAIN. OCCURS MULTIPLE TIMES PER DAY. WORSENING OVER THE LAST MONTH. FOUND TO HAVE SED RATE OF 123. CXR, ECHO, MYOVIEW OK. HOLDER MONITOR PENDING; STARTED ON METOPROLOL.
45 2021-06-15 pain in extremity Swollen lymph nodes in bilateral arm pits; pain in bilateral armpits that radiates to breasts, upper... Read more
Swollen lymph nodes in bilateral arm pits; pain in bilateral armpits that radiates to breasts, upper arms, and down both sides; pain in bilateral armpits that radiates to breasts, upper arms, and down both sides; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231), via an unspecified route of administration, administered in left arm on 05Jan2021 at 05:00 PM (at the age of 45 years old), at second dose, single dose for COVID-19 immunisation. The patient was not pregnant upon vaccination. Medical history included autoimmune disorder. The patient didn't have COVID-19 prior to vaccination and was not tested for COVID post vaccination. The patient was tested for autoimmune more than 10 years ago, but never received a firm diagnosis. Concomitant medications included famotidine (PEPCID AC) and calcium carbonate (TUMS ANTACID). Past drug events included allergy in etodolac (LODINE). The patient was previously administered the first dose of BNT162B2 (Lot number: EH9899) in right arm, on 15Dec2020 (at the age of 45 years) for COVID-19 immunisation. On 06Jan2021, 05:00 PM, the patient experienced swollen lymph nodes in bilateral arm pits 24 hours after the second vaccination. She also had severe pain and tenderness in bilateral armpits radiating into breasts and down sides for one week. Still continuing to have daily pain in bilateral armpits that radiates to breasts, upper arms, and down both sides often requiring ibuprofen. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
45 2021-06-15 pain in extremity getting a headache and got worse and worse; took everything she had not to throw up; arm was very so... Read more
getting a headache and got worse and worse; took everything she had not to throw up; arm was very sore; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Mar2021 15:00 (Batch/Lot number was not reported) at the age of 45 years old as 1st dose, single dose for COVID-19 vaccine. Medical history included had two kids naturally; known allergies with sulfa; hydrocephalus (found in 30's), no shunt. The patient rarely gets headaches. The patient was not pregnant. No other vaccines in four weeks. Concomitant medication included citalopram hydrobromide (CELEXA) taken for an unspecified indication, start and stop date were not reported; and unspecified multivitamin. The patient got her shot on 09Mar2021 15:00 (Tuesday afternoon). The patient's arm was very sore on 09Mar2021 (unknown time, Tuesday and Wednesday; also reported as on 11Mar2021 17:00), but she didn't take anything for the pain. Then on 10Mar2021 (Wednesday; also reported as (12Mar2021), she started getting a headache and got worse and worse throughout the day. It got so bad around 5PM that she thought she was going to have to go to the ER and it took everything she had not to throw up. She ate, drank and took a paracetamol (TYLENOL) and felt a little better. She does not get many headaches and has a very high tolerance for pain (had two kids naturally, no epidural or pain meds). This was the worst headache of her life and was considering not getting 2nd shot. 5 days later and she still has a minor headache. Also, she has never had a reaction to any vaccines in the past. The patient has no COVID prior vaccination and was not tested for COVID tested post vaccination. Outcome of event " took everything she had not to throw up" was unknown, while other events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-06-16 pain in extremity tested positive for Covid; Pain in arm; Dry mouth; a little headache; This is a spontaneous report f... Read more
tested positive for Covid; Pain in arm; Dry mouth; a little headache; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unspecified, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in right arm on 20Jan2021 at 12:00 as 1st dose, single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unspecified, Expire Date: unknown) via an unspecified route of administration, administered in right arm on 12Feb2021 at 19:00 (at the age of 45-year-old) for COVID-19 immunization. The patient' medical history included former smoker; Verbatim: she used to smoke before, so she was a former smoker and high Prolactin; Verbatim: At that time, she had, high Prolactin and does not think she was on medication at that time. The family medical history reported as none. The prior Vaccinations within 4 weeks was reported as none. Additional Vaccines was not administered on same date of the Pfizer suspect. Concomitant medication(s) included gabapentin (GABAPENTIN) (Lot number: unknown, Expiry date: Discard after 30Apr2022) as 300 mg, 3x/day and Patient stopped taking it maybe 2 months ago. She does not think she was taking it even 3 months. She got tired of took it because she did not saw any improvement and bromocriptine (BROMOCRIPTINE) taken for high prolactin, as 2.5 mg, 1x/day with ongoing, she was taking this now but does not recall if she was taking this prior to the COVID-19 vaccine. On 21Jan2021, the patient experienced pain in arm, dry mouth, a little headache. On 24May2021, the patient had COVID-19 positive. 07Jun2021, Monday, the patient went back for a test again and it was negative. She stated that, she had 2 kids. She was scared of COVID-19 and wanted to be secure and safer. At that time, she had, high Prolactin and does not think she was on medication at that time. Maybe, she was not too sure. She could not recall if she was taking Bromocriptine, she was taking it now. She stated that the only side effect she had was pain in her arm for the first dose, and dry mouth and a little headache. It started the next day and lasted only one day. The patient underwent lab tests and procedures which included COVID-19 test: positive on 24May2021 and COVID-19 test: negative on 07Jun2021. Patient was not received treatment for the adverse event. The outcome of the event tested positive for COVID-19 was recovered on 07Jun2021, all other events was unknown.
45 2021-06-16 tingling, burning sensation The day after I had nausea, fever, chills, stomach ache, burning sensation in my legs and hot to the... Read more
The day after I had nausea, fever, chills, stomach ache, burning sensation in my legs and hot to the touch...that lasted one hour. The day after these burning sensations went all over my body that lasted two weeks. These last two weeks only the burning sensation is in my legs. The doctor diagnosed me with Paresthesia, and gave me Gabapentin.
45 2021-06-16 throat numbness Patient received the COVID-19 vaccine IM in her left arm at 1618. At 1638, she complained of tinglin... Read more
Patient received the COVID-19 vaccine IM in her left arm at 1618. At 1638, she complained of tingling/numbness to her tongue and gums as well as her throat. She also developed marked nasal congestion. At 1644, that patient was administered an Epipen. By 1646, her nasal congestion resolved and there was no progression of her tingling/numbness however these both lasted until transfer to ED by 1645 for close observation/follow-on therapy. Patients vital signs remained appropriate for interventions.
45 2021-06-17 burning sensation Feeling light headed; Burning in neck; This is a spontaneous report from a contactable other healthc... Read more
Feeling light headed; Burning in neck; This is a spontaneous report from a contactable other healthcare professional. A 45-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0217) via intramuscular route, in left arm on an unspecified date (at the age of 45-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergies to betadine, latex gloves, septra, lamotrigine, premarine, topamax. Chronic or long-standing health conditions included: migraines, IBS, thyroid, esophagitis. Prescriptions over the counter medications, dietary supplements, herbal remedies being taken at the time of vaccination were not aware of any. Not aware of any for patient other illness at the time of vaccination and up to one month prior. The patient previously received first dose of BNT162B2 (Lot Number: unknown) via an unspecified route of administration on an unspecified date (at the age of 45-years-old) as single dose for COVID-19 immunisation and experienced sore arm and a migraine headache. The patient's concomitant medications were not reported. On an unspecified date, after 2nd dose of Covid vaccine, the patient feeling light-headed and burning in neck. Clinical course included: patient came in for 2nd dose of Covid vaccine, asked patient had first vaccination went, she said sore arm and a migraine headache after but otherwise no problem. Gave patient with no issues and kept her in the area for observation. Patient came back to the counter 5 minutes later feeling light-headed and burning in neck. The event feeling light-headed resulted in emergency room visit. The outcome of the events was unknown.
45 2021-06-17 migraine, pain in extremity sore arm; migraine headache; This is a spontaneous report from a contactable Other Health Profession... Read more
sore arm; migraine headache; This is a spontaneous report from a contactable Other Health Professional. A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as (at the age of 45-years) 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Reportedly, patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0217), dose 2 via intramuscular route of administration on 15Jun2021 12:00 PM (at the age of 45-years) 2nd dose, single dose for covid-19 immunisation. Medical history included migraine, IBS, thyroid disorder, oesophagitis. Allergies to medications, foods, or other products: Betadine, Latex Gloves, Septra, Lamotrigine, Premarin, Topamax. The patient concomitant medications were not reported. The patient experienced sore arm, and migraine headache after first dose on an unspecified date. It was reported that patient went for 2nd dose of covid vaccine and was asked how first vaccination went, she said sore arm and a migraine headache after but otherwise no problem. The outcome of events was unknown. Information on lot/batch number has been requested.
45 2021-06-17 pain in extremity Swelling, soreness, tightness, and redness on my lower left leg, ankle and foot. Started around end... Read more
Swelling, soreness, tightness, and redness on my lower left leg, ankle and foot. Started around end of May and progressively go worse (site/place spread from foot to knee over time).
45 2021-06-17 pain in extremity Generalized arm pain after injection, severe fever, chills, brain fog, swollen lymph nodes, severe f... Read more
Generalized arm pain after injection, severe fever, chills, brain fog, swollen lymph nodes, severe fatigue. Symptoms were most severe for 18 hours after shot. Swollen lymph nodes and severe fatigue continued for two weeks post shot.
45 2021-06-18 weakness Feeling like she was going to faint many times a day; Really really weak; Dizziness; Feeling pressed... Read more
Feeling like she was going to faint many times a day; Really really weak; Dizziness; Feeling pressed in her chest and head; Feeling pressed in her chest and head; Weak muscles; Lymph nodes were inflamed on her neck; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 20May2021 at 17:00, at the age of 45 years old, as 1st single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Past drug hisory included amoxicillin sodium/clavulanate potassium (AUGMENTIN) and sulpha. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the had never been patient diagnosed with COVID-19. The patient reported feeling really really weak, having dizziness, and feeling like she was going to faint many times a day. She was feeling pressed in her chest and head, and weak muscles, lymph nodes were inflamated on her neck, for 20 days from the vaccination. The onset date of all events was reported as 20May2021 at 17:30. Due to the events the patient visited her doctor and emergency room. She was treated with celecoxib (CELEBRA) and arginina aspartate (SRGENOR FORTE). A polymerase chain reaction/nasal swab for COVID-19 done on 01Jun2021 turned negative. The patient had not recovered from the above mentioned events. Follow-up actions are needed. Further information has been requested.
45 2021-06-20 tingling 15 min after the shot, I filled tingling (pins and needles) on my eye, then it happened random every... Read more
15 min after the shot, I filled tingling (pins and needles) on my eye, then it happened random everywhere , from Face, head, hands back, legs, both sides of the body, it is 27 hours after the shot and still happening.
45 2021-06-21 pain in extremity, night sweats Shortness of breath; Asthma symptoms/second shot exacerbated her asthma; runny nose; night sweats; h... Read more
Shortness of breath; Asthma symptoms/second shot exacerbated her asthma; runny nose; night sweats; headache; fatigue; pain in arm; fever; Body aches; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route in the left arm, on 19Apr2021 at 17:15 (lot/batch no: EW0164, expiration date: 31Aug2021), as 2nd dose, single dose, for COVID-19 immunization (at the age of 45-years), at a clinic. The patient was not pregnant at the time of vaccination. Medical history included, Sjogren's syndrome from 2015, asthma, unspecified allergies, and autoimmune disorder. Concomitant medications included fish oil (FISH OIL), biotin (BIOTIN), paracetamol (ACETAMINOFEN), montelukast sodium (SINGULAIR) taken for asthma from 2015. Historical vaccine included the first dose of COVID-19 vaccine (Lot number: ER8737) on 30Mar2021 at 17:15PM as 1st dose, single dose in the left arm , at age 45 years old, for COVID-19 immunization. The patient previously took sulfonamide and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Apr2021, the patient had body aches, fever, and on 21Apr2021, the patient experienced shortness of breath, asthma symptoms, pain in arm, runny nose, night sweats, headache, fatigue and flu like symptoms on an unspecified date in Apr2021. The patient stated that after the second dose she ended up going to emergency room for shortness of breath. Now it has been more than a month and she is still having problems breathing. The doctor said the second shot exacerbated her asthma. Caller adds she has autoimmune disease and has had asthma for some time but usually has no symptoms. She only has any problem when she has seasonal allergies. Wednesday the body aches and fever subsided but she started to have shortness of breath. Adds she couldn't get into the pulmonary doctor, so she went to the emergency room on Friday evening 23Apr2021. She was there a few hours; they did x rays and EKG and blood work and urine. Everything was fine. They told her to see her pulmonary doctor. They did give her ibuprofen (Ibuprofen 600mg; manufacturer Time CatLab; no NDC, lot or expiration date). Has use by date of 26Apr2021. When she went to the pulmonary doctor her treated her with prednisone and Symbicort (Symbicort; NDC 0186 0370 20; lot 3002410C00, expiration date: Feb2022). She was still experiencing shortness of breath which was worse when she lays down or sits back. She had a CAT Scan on her lungs which the pulmonologist said looks fine. He said it was taking her a long time to recover from the shot. He gave her second inhaler (Spiriva Respimat - sample inhaler; NDC not seen on the sample package; lot 905836B; expiration Sep2022), but nothing was correcting the issue, she states the Prednisone is long gone, it was six days package; no NDC, lot or expiration date. The patient underwent lab tests and procedures which included blood test: normal (everything was fine) on 23Apr2021, electrocardiogram: normal (everything was fine) on 23Apr2021, urine analysis: fine (everything was fine) on 23Apr2021, x-ray: normal (everything was fine) on 23Apr2021, and CAT scan: normal on an unspecified date. The outcome of the events was not recovered except for the events fever, flu like symptoms and body aches which resolved on 21Apr2021. On 10Jun2021, investigation result and expiry date: 31Aug2021 for lot number EW0164 were provided by the product quality complaints group. The summary of investigation was as follows: The initial scope of the investigation was limited to the reported finished goods lot EW0164, fill lot EP8696, and the bulk formulated drug product lot EP8593. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records were examined for the reported complaint lot. Pfizer did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective or preventative actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch meets potency specifications. There is no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the (name) site. Impact Analysis: Based on the final scope of the investigation, which was limited to the reported finished goods lot and associated fill and formulated drug product lots, and that a root cause related to the production process was not identified, the reported issue is not representative of the lot and does not indicate a negative impact on product quality. No regulatory notification is required. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0164 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0164, fill lot EP8696, and the formulated drug product lot EP8593. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are needed. No further information is expected. Follow-up (10Jun2021): New information received from the product quality complaints team includes: investigation result and expiry date for lot number EW0164. Additionally, the description as reported of the event coded to asthma was updated to "Asthma symptoms/second shot exacerbated her asthma". Information on lot/batch number was available. Additional information has been requested.
45 2021-06-21 pain in extremity Soreness of the left arm
45 2021-06-21 tingling, hot flush Pt complained of hot flash and tingling in her right arm and right finger tips.
45 2021-06-22 flushing pt started to feel flushed and red, itchy, it subsided ten minutes after zyrtec administration
45 2021-06-22 speech disorder, weakness Current Issues - Shortness of breath and difficulty in breathing, Chest Muscle tightness and heavine... Read more
Current Issues - Shortness of breath and difficulty in breathing, Chest Muscle tightness and heaviness. Difficulty in talking or speaking. Body fatigue, weakness/tiredness. Did Heart EKG but result came out normal. Chest X-Ray was normal Urgent Care and PCP prescribed "Albuterol Sulfate Hfa" through Nebulizer, taking while difficulty in breathing
45 2021-06-23 inability to speak I experienced Aphasia for about one hour. I was unable to understand written words and unable to thi... Read more
I experienced Aphasia for about one hour. I was unable to understand written words and unable to think of words I wanted to say. (Example: I wanted to tell someone I was on vacation "for the next few days" but I wrote "for the next few years," then corrected this to "the next few weeks," but could not think of the word "days." I saw the word "folk" and kept reading it as "work." I knew I wasn't getting it right but needed someone else to tell me the correct word. I also experienced a blurry dot directly in the center of my vision. This lasted about 15 minutes. I understand the University has had 4 women come in with Aphasis about 2 weeks after their 2nd vaccine.
45 2021-06-23 pain in extremity, weakness, muscle spasms Shortly after the shot itching all over began, with no hives. About 15 minutes after the dose, star... Read more
Shortly after the shot itching all over began, with no hives. About 15 minutes after the dose, started with racing heart rate, shortness of breath, dizziness and near syncope, weakness, nausea. Then started with 30 minutes of legs spasming/trembling. Ears, throat, tongue itching and wheezing. No treatment administered by the facility. I used my own inhaler for the wheezing. Was then largely fine for about 6 hours at which time arm soreness began, following by fever, sweats, chills, exhaustion, nausea, lymph node swelling, body aches. High fevers and sweats for 36 hours (Did not take over night or through next morning but must have been well over 102 as I felt like I had pneumonia and felt remarkably better and could eat the second evening at which time I could check and it was 102). Already much improved by beginning of third day. Towards the middle/end of week one, however, began with eye pain and increased asthma symptoms, some transient hives periodically, and physically tired. Palpitations and chest pain began late last evening. If it gets like after shot 1, I will seek medical evaluation this time.
45 2021-06-23 pain in extremity After the vaccine my arm was sore for about a day or two. A couple weeks later I was told I had bron... Read more
After the vaccine my arm was sore for about a day or two. A couple weeks later I was told I had bronchitis and developed into walking pneumonia.
45 2021-06-23 tenderness, pain in extremity I received both doses of the vaccine, one in each arm. The first dosis i received in the right arm... Read more
I received both doses of the vaccine, one in each arm. The first dosis i received in the right arm, the arm was sore for about two days and then it went away. When it was time for my second dosis iI received it on my left arm., The day of the injection i did not experience any soreness, however as time passed i started feeling at lot of paint on my left arm. i cannot my my arm in a certain position because it hurts too much. I an unable to sleep on my left side because of pain it causes. I have loss strength on the arm and it feels sore to the touch .
45 2021-06-23 unresponsive to stimuli, tremor pt with lightheadedness after 30 min wait after covid vaccine. rechecked and noted to have "white ... Read more
pt with lightheadedness after 30 min wait after covid vaccine. rechecked and noted to have "white light" vision. RN notified. patient brought back to procedure room for monitoring. transferred to gurney. vitals taken. noted shakey, but states she gets shakey sometimes. noted staring gaze for a moment. went to get MD. noted to have unresponsiveness for a couple seconds. sternum rub to stimulate. MD to bedside and 911 initiated.
45 2021-06-24 numbness chills; numbness inside mouth and face; numbness inside mouth and face; This is a spontaneous report... Read more
chills; numbness inside mouth and face; numbness inside mouth and face; This is a spontaneous report from a contactable consumer (Patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734, Expiration date: Unknown), via an unspecified route of administration on 12Apr2021 at 10:00 (at the age of 45-year-old), as 1st dose, single in deltoid Left, for COVID-19 immunisation. The patient's medical history included sensitive to medication. Concomitant medications were not reported. The patient's historical vaccine included flu shot administrated on an unspecified date in 2021, and experienced pain in joints for like a couple of weeks. On an unspecified date, after the administration of the first dose of vaccine, the patient experienced chills for like a week, numbness inside mouth and face. The clinical outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
45 2021-06-24 pain in extremity I had a rash that broke out on my face, severe fatigue, sore arms, major pelvic pain
45 2021-06-24 tingling Patient called later in the afternoon of her COVID vaccination stating her lips and cheeks were feel... Read more
Patient called later in the afternoon of her COVID vaccination stating her lips and cheeks were feeling odd, which she described as a tingling feeling. She stated this started about an hour after her vaccine. She had access to benadryl but had not taken any at that point. She was advised to seek immediate medical attention if she started having any trouble breathing or her throat felt like it was closing up. We spoke to the patient a few hours later and she still had some tingling in her upper lip, but was feeling better than earlier. The next day, we followed up again and she had taken a dose of bendaryl the previous evening and she stated that her tongue is now feeling "thick", but her lips and cheeks were no longer tingling. She also said that she is not having any trouble breathing (and possibly thinking to much about vaccine) - but felt like she could not take as deep a breath as normal. She said she can perform all daily activities including exercising.
45 2021-06-27 feeling hot Approximately 7-8 minutes after vaccination, I felt a sudden onset of GI distress, which was immedia... Read more
Approximately 7-8 minutes after vaccination, I felt a sudden onset of GI distress, which was immediately followed by an intense heat rush and profuse sweating on forehead and nape of neck. I alerted medical staff, who began monitoring my pulse and blood pressure. Both readings were normal/non-remarkable. I stayed another 15 minutes and had staff take vitals again, both were normal readings (pulse/heart rate was 40 and blood pressure was 121/81). Then on 04/26/21 (on 8th day after vaccination), I had a sudden feeling of being unwell/lightheadedness. I used a home pulse oximeter to check vitals, heart rate was 35 and pulse ox was 80%. Along with near syncope, I also starting experiencing symptoms of hypoxia, which were witnessed by family members. As I was uncertain what was happening, I didn't go immediately to hospital, but later called my doctor for an appointment. On 4/27/21, my Dr was able to document an irregular heartbeat through clinical examination, and ordered bloodwork, a Holter monitor, and referred me to a cardiologist. The initial bloodwork did not indicate a heart attack. However, the Holter monitor, which wasn't installed until 5/3/21 (a week after the initial incident) showed bradycardia, junctional rhythms, and PVCs. Holter monitor only used until 5/17/21. The echocardiogram, which was performed on 5/17/21, showed a mitral valve prolapse. Because of the ongoing issues with bradycardia (resting heart rates on watch showing as low as 35, 36, 37, 38, and 39 overnight), and many PVCs (Holter monitor showing PVCs and multifocal PVCs) along with experiencing symptoms with PVCs, a general cardiologist, has referred me to an electrophysiologist. The appointment is scheduled for 8/5/21, so this issue is ongoing, and the end result of the vaccination effects are unknown at this time.
45 2021-06-27 pain in extremity So I have excruciating pain in my left shoulder blade, shoulder, arm, fingers and hand. It keep me u... Read more
So I have excruciating pain in my left shoulder blade, shoulder, arm, fingers and hand. It keep me up at night because of the pain. It is a constant and sever pain. I am seeing a chiropractor and acupuncture on my own, it's not covered.
45 2021-06-27 pain in extremity The pain in my arm post vaccination on 5.6.21 never fully went away. It got better for a couple we... Read more
The pain in my arm post vaccination on 5.6.21 never fully went away. It got better for a couple weeks but still noticed it. Around the beginning of June, the pain in my arm, at the vaccination site, started to intensify. I kept an eye on it for a couple weeks, thinking it'd get better but it didn't, it just got worse. On Tuesday, June 15th the pain really intensified. To the point that by Thursday, June 17th I was unable to move my arm. Because the pain was so bad I went to Urgent Care where they thought I was having muscle spasms. I knew something wasn't right so I contacted my doctor that afternoon who then sent me for blood work. He ran a D-dimer test which came back elevated on Friday June 18th. From there I went to the ER so they could run a doppler scan on my left arm. The pain was so bad they were only able to do half the test but quickly saw that I have a blood clot in one of the veins. The ER doctor put me on Eliquis and now here I am.
45 2021-06-28 flushing Systemic: Flushed / Sweating-Mild, Additional Details: She said probably triggered are anxiety
45 2021-06-28 pain in extremity I am having a lot of sleep and I am tired. I feel like I'm losing my sight. My feet and joints hurt.... Read more
I am having a lot of sleep and I am tired. I feel like I'm losing my sight. My feet and joints hurt. I went to the same clinic where they gave me the vaccine and they prescribed Motrin. They did blood and urine studies that same day.
45 2021-06-28 pain in extremity 5/31/21 had back chest neck arm pain, went to medic, went into cardiac arrest, the did 18 minutes of... Read more
5/31/21 had back chest neck arm pain, went to medic, went into cardiac arrest, the did 18 minutes of CPR, got a heart rate, medivac?d me to Anchorage, AK spent 4 days in ICU, was told I had cardiac arrest due to pulmonary embolus,. Got a defibrillator installed in my chest.
45 2021-06-28 seizure I had little light seizures; I had little light seizures; Dizziness; My head was hurting; This is a ... Read more
I had little light seizures; I had little light seizures; Dizziness; My head was hurting; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 17May2021 (Lot Number: EW0170) (at age of 45-year-old) for covid-19 immunisation. Medical history included type 2 diabetes mellitus, asthma, High blood pressure, High cholesterol, thyroid disorder, cardiac failure congestive, acid reflux, and seizure. There was no other vaccine in four weeks. Concomitant medications included lisinopril taken for hypertension, start and stop date were not reported; phenytoin (DILANTIN) taken for seizure, start and stop date were not reported; topiramate (TOPAMAX) taken for seizure, start and stop date were not reported; verapamil hydrochloride (CALAPTIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported. On 17May2021, the patient stated, "Well, I have Type 2 Diabetes, plus I have some 'disc in heart' (Further clarification unknown)and I have Seizures and I have Asthma and High Blood Pressure. I have a lot of Heath Problems. And I felt Dizziness. My head was hurting. I had little light seizures." The patient underwent lab tests and procedures which included seizure levels : unknown results on 11May2021, diabetes mellitus: glucose low on 11May2021. No treatment was received for the events. The outcome of event 'little light seizures ' was unknown, of other events was recovering.
45 2021-06-29 breast pain Pain in left breast; extreme tenderness in left breast outer and bottom quadrants; This is a spontan... Read more
Pain in left breast; extreme tenderness in left breast outer and bottom quadrants; This is a spontaneous report received from a contactable other healthcare professional, the patient. A 45 years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route administration on the left arm on 03Mar2021 at 10:30, (at the age of 45 years) as a single dose, for COVID-19 immunisation. Medical history includes allergic asthma, hypothyroidism and dense breasts. The patient had anaphylactic allergy to salmon and latex allergy. Concomitant medications include SYNTHROID, AVIANE OC (oral contraceptive), probiotic (MANUFACTURER UNKNOWN), W-3 fish oil, B3 (MANUFACTURER UNKNOWN); all started on an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 03Mar2021 at 23:00, the patient experienced pain and extreme tenderness in her left breast that started about 12 hours after vaccination; tenderness was in the outer and bottom quadrants. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken for the event which included cold packs. The clinical outcome of the events pain in left breast and extreme tenderness in left breast, outer and bottom quadrants were resolved on an unknown date in Mar2021 (after 2 weeks with use of frequent cold packs). No follow-up attempts are needed. No further information was expected.
45 2021-06-29 numbness Generalised numbness; This is a spontaneous report received from a contactable consumer, the patient... Read more
Generalised numbness; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration in the right arm on 26Feb2021 at 12:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamins. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Mar2021 at 12:00, about 15 days after the vaccine, the patient began to experience numbness in her leg which over the next day travelled to her right side, and eventually to her face and mouth. The sensation increased and decreased in intensity and location but never completely went away. The patient visited a doctor and they thought the vaccine triggered a reaction in her L5 band for which she was prescribed medication. Therapeutic treatment taken for the reported event was celecoxib, tizanidine and gabapentin. The patient underwent lab tests and procedures, which included blood test and an MRI on her head which showed nothing of interest to the doctors. The clinical outcome of the generalised numbness was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
45 2021-06-29 muscle spasms Cramps on left leg between Soleus and Tendons; This is a spontaneous report received from a contacta... Read more
Cramps on left leg between Soleus and Tendons; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0161) via an unspecified route of administration on left arm 20Apr2021 at 08:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. No relevant medical history was reported by the patient. The patient had no known allergies. Concomitant medications included norethisterone (DEBLITANE) and amlodipine (MANUFACTURER UNKNOWN) since an unknown date for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 22Apr2021 at 10:30, the patient experienced cramps on left leg between soleus and tendons. The cramps started 2 days after the vaccination and remained for 3 days. It was still present and was not getting worse or better and normal muscle pain should have gone away. Therapeutic measures included acupuncture for the reported event cramps leg. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
45 2021-06-29 pain in extremity Bruised feeling; Left arm sore; This is a spontaneous report received from a contactable consumer, t... Read more
Bruised feeling; Left arm sore; This is a spontaneous report received from a contactable consumer, the patient. A 45-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on the left arm, on 09Mar2021 at 13:00, as a single dose for COVID-19 immunisation (at the age of 45-years-old). Medical history included high blood pressure (controlled with medication). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received unknown medications within 2 weeks of vaccination. It was reported that the patient was allergic to sulfer, bacterium and avelox. On 09Mar2021 at 15:00, the patient experienced pain in arm. It was reported that the patient took Tylenol for the pain. Patient reported that the left arm was sore for 2 days went away, 5 days later on 14Mar2021 the pain came back bruised feeling and very warm to touch. It was day 11 past injection day and it was still sore. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events pain in arm and bruised feeling was not resolved at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
45 2021-06-29 pain in extremity Sore and achy arm started 4 hours post 2nd vaccine, woke 3am with 99.6F fever, chills, muscle aches ... Read more
Sore and achy arm started 4 hours post 2nd vaccine, woke 3am with 99.6F fever, chills, muscle aches (back, neck and legs), headache and right ear ache. Fever down to 98.7F without any fever reducers; Still having chills; muscle/body aches; 99.6F fever; headache; right ear ache; This is a spontaneous report from a contactable consumer (patient herself). A 45-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:00 (age at vaccination 45-year-old) (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19. The patient's medical history included Hashimoto's Thyroid Disease (for 20 years now), Arthritis in toe joints (for 10 years now) and allergy only environmental allergens (Outdoor and indoor). The historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in Left Arm on 27Jan2021 11:30 AM for COVID-19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID) and eicosapentaenoic acid ethyl ester (VASCEPA) taken for an unspecified indication, start and stop date were not reported. It was reported that patient experienced Sore and achy arm started 4 hours post 2nd vaccine (18Feb2021 03:00), woke 3am with 99.6F fever, chills, muscle aches (back, neck and legs), headache and right earache. Fever down to 98.7F without any fever reducers at 7.30am but back up to 100F an hour later. At 10 am down to 97.6F. Still having chills and muscle/body aches. Other medications in two weeks includes Synthroid 75 mcg daily, Vascepa 200 mg twice a day. The patient did not receive any treatment for adverse events. Patient did not diagnose with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
45 2021-06-29 tingling, feeling hot, numbness 6/4 I had mild headache, fever, sleepiness, 6/5 woke up to swollen lymph node in left armpit, 6/6 wo... Read more
6/4 I had mild headache, fever, sleepiness, 6/5 woke up to swollen lymph node in left armpit, 6/6 woke up to pain in injection site with red circle. "COVID arm lasted only 2 days, but Swollen lymph node about 2+ weeks. On 6/7 started feeling random intermittent numbness and tingling in arms, legs, face and heat sensations in back chest and abdomen. Mind feels foggy, some vertigo feelings. Got more intense by 6/9 and got scared to went to ER. Urine and blood results didnt show anything bad so Dr. diagnosed as paresthesia. Symptoms have bot gone away and started feeling heat and head pressures top/back of head that comes and goes. Went to Dr. he thinks I have anxiety which is likely true, but I cannot get the head pressures to subside. I still feel foggy and like my body is trying to fight off an infection of some sort
45 2021-06-29 tremor, pain in extremity extreme tiredness; medium grade headache; pain throughout the whole body; High fever (102F); Strong ... Read more
extreme tiredness; medium grade headache; pain throughout the whole body; High fever (102F); Strong shaking throughout the whole body; pain down the left arm; Tenderness at the injection site; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The concomitant medications included cetirizine (ZYRTEC) for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 26Feb2021 at 15:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient previously received tetracycline (MANUFACTURER UNKNOWN), vancomycin (MANUFACTURER UNKNOWN) and cipro (MANUFACTURER UNKNOWN) for unknown indications on unknown dates and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 20Mar2021 at 03:45, the patient experienced strong shaking throughout the whole body and pain down the left arm for approximately 30 min at 03:55, the following day after the shot. Pain reduced in severity, but changed to the pain throughout the whole body. High fever (102F) throughout the day, medium grade pain especially on the left side of the body, medium grade headache. On the 2nd day pain and headache subsided but experienced Tenderness at the injection site, Nausea and extreme tiredness throughout the day. On third day most symptoms were gone and had slight tiredness. Therapeutic measures were taken for the events and shaking subsided after 2 (200mg/each) Ibuprofen pills. Pain reduced in severity, but changed to the pain throughout the whole body. Headache, body pain and fever was better controlled with Tylenol (500mg). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events shaking, pain down the left arm, high fever, headache, body pain, Tenderness at the injection site, Nausea and tiredness was recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
45 2021-06-30 tingling nose bleeds; headache; dizziness; tingly; This is a spontaneous report from a contactable consumer, ... Read more
nose bleeds; headache; dizziness; tingly; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine, Lot number: unknown) via an unspecified route of administration on 18Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and penicillin allergy. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), all from unknown dates and unknown indications. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021, the patient experienced nose bleeds, headache, dizziness and tingly. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the reported events. The clinical outcome of the events nose bleeds, headache, dizziness and tingly was unknown at the time of this report. Information on lot/batch number has been requested.
45 2021-06-30 tension headache Fever of 100F next day lasted for several hours; Tension headaches; extreme fatigue; lightheadedness... Read more
Fever of 100F next day lasted for several hours; Tension headaches; extreme fatigue; lightheadedness; depression lasted for two weeks.; This is a spontaneous report from a non-contactable consumer or other non-health care professional. A 45-years-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EL6198), dose 2 via an unspecified route of administration, administered in Arm Right on 10Mar2021 15:45 (Age at vaccination 45 Years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included multiple allergies, Mild allergies to bactrum, pollen, and some foods. The patient's concomitant medications were not reported. Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 11Mar 2021 Fever of 100F next day lasted for several hours. Tension headaches, extreme fatigue, light-headedness and depression lasted for two weeks. No treatment received for the adverse events. The outcome for all events was recovering. No follow-up attempts are possible. No further information is expected.
45 2021-07-01 pain in extremity PATIENT REPORTED NAUSEA, PAIN ON LEFT THIGH AND HEADACHE. PATIENT SAID THAT SHE HAS AN APPOINTMENT ... Read more
PATIENT REPORTED NAUSEA, PAIN ON LEFT THIGH AND HEADACHE. PATIENT SAID THAT SHE HAS AN APPOINTMENT COMING UP ON 7/15/21 BUT HAS NOT RECEIVED ANY TREATMENT YET.
45 2021-07-02 night sweats Chills; Fever; Night Sweats; Headache; Muscle Aches; Exhaustion; This is a spontaneous report from a... Read more
Chills; Fever; Night Sweats; Headache; Muscle Aches; Exhaustion; This is a spontaneous report from a non contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207) via an unspecified route of administration in the left arm on 18March2021 at 14:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to penicillin. The patient had not received any other vaccines within four weeks prior to the vaccination. It was unknown whether prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19March2021 at 15:00, the patient experienced chills, fever, night sweats, headache, muscle aches and exhaustion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events chills, fever, night sweats, headache, muscle aches, exhaustion was recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
45 2021-07-04 weakness Extreme tiredness and depression - not wanting to do anything Cold-like symptoms Cough
45 2021-07-05 pain in extremity 3 days after I received my injection, I had pain in my left arm. I did not have any other symptoms a... Read more
3 days after I received my injection, I had pain in my left arm. I did not have any other symptoms at that time. I never really had any symptoms until about 3 weeks ago. My stomach has been upset. I am not sure if it is related to the vaccine. I have had an upset stomach and I have been throwing up. I was put on omeprazole for my upset stomach. I went to see my doctor about 3 weeks ago when my symptoms started. I never took any tylenol for the soreness on my arm.
45 2021-07-05 tingling, numbness, pain in extremity The day after receiving the COVID19 shot (upper left arm), I experienced swelling with a dull, insis... Read more
The day after receiving the COVID19 shot (upper left arm), I experienced swelling with a dull, insistent pain that seemingly moves down the back of my arm to my elbow and forearm and will occasionally cause the back of my hand and fingers to tingle or go numb. While the swelling went down within 3 days, the uncomfortable pains have persisted and somewhat worsened. I occasionally will feel a slight pain in my chest, which made me initially think it was due to my HBP, but my pressure was normal and I have taken my pills during this time.
45 2021-07-05 seizure I started to breakout in hives and welts. I was itchy. They thought I had a seizure. My heart rate w... Read more
I started to breakout in hives and welts. I was itchy. They thought I had a seizure. My heart rate was high. The following day I went back to the ER they thought I had another seizure. Two days later I went back to the ER for abdominal pain.
45 2021-07-06 muscle spasms, pain in extremity, tingling, weakness, burning sensation Hives on right thigh day after vaccination, fatigue at day 3, around 10 days after couldn't walk for... Read more
Hives on right thigh day after vaccination, fatigue at day 3, around 10 days after couldn't walk for 2 weeks, arms weak, lots of pain, cramping, and burning, tingling, 'bubble popping' sensations under my skin. Doctors have not helped. I researched and am taking a new multi-vitamin with methyl versions of B vitamin, Boswellia, MSM, Ashwaganda, Fenugreek for excess estrogen, phospahtidylserine, glycine, vitamin B8, betaine, and some (Traditional Medicines), Co-Q-10, Hawthorne, 81 mg aspirin, and some other supplements as needed such as Alpha Lipoic Acid, Lutein, and N-Acetyl something or other...
45 2021-07-06 pain in extremity I developed shingles rash and pain in the left thigh and hip. I was prescribed acyclovir for 10 days... Read more
I developed shingles rash and pain in the left thigh and hip. I was prescribed acyclovir for 10 days. During this time I also had lip swelling and needed to be prescribed benadryl and predisone. I was not getting better so my husband took me to the hospital ER on June 20, 2021. I was admitted with concern over a delayed and continual reaction to the vaccine.
45 2021-07-07 weakness, tremor My heart rate was measured at 194 beat per minute/woke up from a very strong and fast heartbeat; My ... Read more
My heart rate was measured at 194 beat per minute/woke up from a very strong and fast heartbeat; My whole body was shaking; shortness of breath; general weakness; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46 years old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 02May2021 at 16:00 (at age of 45 years old, no pregnant, Lot Number: ER8736) as a single dose for covid-19 immunization. Medical history included Penicillin Allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine and not receive any other medications within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Apr2021 at 13:00 (at age of 45 years old, no pregnant, Lot Number: EW0150) as a single dose for covid-19 immunization. The night of 15May2021 at 3:00, the patient woke up from a very strong and fast heartbeat. Her whole body was shaking, she had experienced shortness of breath and general weakness. After realizing that something was wrong she went to an Emergency room. The patient heart rate was measured at 194 beat per minute. Events resulted in Emergency room/department or urgent care. The patient received treatment (Valsalva Maneuver). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered. Follow-up attempts are completed. No further information is expected.
45 2021-07-07 tingling Swelling of cheeks, tongue, and lips (not severe-patient was able to still breath and talk properly)... Read more
Swelling of cheeks, tongue, and lips (not severe-patient was able to still breath and talk properly). Stated that the areas just felt tight/tingly/itchy
45 2021-07-07 tremor, numbness I have tremors, full body conviction, and paralysis in lower body since June 8th. I have severe head... Read more
I have tremors, full body conviction, and paralysis in lower body since June 8th. I have severe headaches, vision loss, and light flashes. I have numbness in both lower and upper extremities. I had brain fog and memory lost. I was hospitalized for 5 days. They diagnosed with bilateral leg weakness. They did an MRI of complete spine, EKG, and a CT of brain with no contrasts. Everything came back normal.
45 2021-07-08 weakness generalized Weakness and SOB right after receiving the COVID VACCINE TODAY. She admits to eating a... Read more
generalized Weakness and SOB right after receiving the COVID VACCINE TODAY. She admits to eating and drinking earlier today. She states that her mouth is very dry despite drinking water. She denies any dizziness, chest pain or palpitations. No rash.
45 2021-07-08 burning sensation, feeling hot, flushing Immediately felt burning down arm and into shoulder after vaccine was administered; went to sit down... Read more
Immediately felt burning down arm and into shoulder after vaccine was administered; went to sit down in observation area felt like she was light-headed and going to pass out, hot, sweaty, pale, flushed, vomited x1 while observed. EMS on site responded with cool packs, elevated feet, gave water to drink.
45 2021-07-08 numbness, tingling I woke up with tingling on my fingers and legs. Light pressure on my left chest. I went back to slee... Read more
I woke up with tingling on my fingers and legs. Light pressure on my left chest. I went back to sleep and chest pressure was gone but I still have tingling on my arm and also a little numb on my cheeks.
45 2021-07-08 migraine Massive hair loss; migraines came back; menstrual cycle all messed up; vaccine is administered on th... Read more
Massive hair loss; migraines came back; menstrual cycle all messed up; vaccine is administered on the same date; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: WG10190, Expiration date: Not reported), via unspecified route, administered in left arm on 31Mar2021 (at the age of 45-year-old) as dose 2, single; and first dose of BNT162B2 (Lot Number: WG10190) via an unspecified route of administration, administered in left arm on 31Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history includes Chronic migraines. And patient had known allergies to Sulfur. No other vaccine 4 weeks prior to covid vaccine. Concomitant medications were not reported but Patient received few mediations within 2 weeks of vaccination and details unknown. Prior and post vaccination, patient was not diagnosed and tested with covid 19. On 15Apr2021, after the vaccination, the patient experienced Massive hair loss, migraines came back, and menstrual cycle all messed up. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the events is not recovered. Information on Lot/Batch number was available. Additional information has been requested.
45 2021-07-08 pain in extremity, weakness Fever; Chills; Weakness; Soreness in shot arm; This is a spontaneous report from a contactable consu... Read more
Fever; Chills; Weakness; Soreness in shot arm; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration into left arm on 24Mar2021 at 16:15 (at the age of 45-year-old) as single dose for COVID-19 immunisation. The patient did not have any medical history. The patient received birth control (MANUFACTURER UNKNOWN) within two weeks of vaccination. No known allergies were reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 15:00, the patient experienced fever, chills, weakness and soreness in shot arm. The adverse event did not result in a visit to the doctors or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No treatment was received for the adverse events. The clinical outcome of events fever, chills, weakness and painful arm were not resolved at the time of this report. No follow-up attempts possible. No further information expected.
45 2021-07-08 pain in extremity Arm pain; Muscle aches; Fatigue; Headache; This is a spontaneous report received from a contactable ... Read more
Arm pain; Muscle aches; Fatigue; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 45-years-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955] via an unspecified route of administration in left arm on 24Mar2021, at 09:00, (at the age of 45 years-old) as a single dose, for COVID-19 immunisation. Medical history included hypothyroidism, gastroesophageal reflux disease (GERD), migraines, eczema, environmental allergies and seasonal allergies, since unknown dates. The concomitant medications included rt (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), azelastine hydrochloride; fluticasone propionate (DYMISTA), all on unknown dates taken for unknown indication and injection alave (MANUFACTURER UNKNOWN) taken for allergy. The patient previously took her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247] via an unspecified route of administration on 02Mar2021, at 10:00, (at the age of 45 years-old) as a single dose, for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 20:00, the patient had experienced local events very minor arm pain (pain in arm), systemic events minor muscle aches (muscle ache), mild fatigue (fatigue) and moderate headache (headache). The patient marked, selected not recovered because she still had mild fatigue, muscle aches and a mild (versus previously moderate) headache, but they were improving at the time of this report which was approximately 17 hours post onset. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the events. The clinical outcome of events pain in arm, muscle ache, fatigue and headache were not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
45 2021-07-08 pain in extremity left armpit began to significantly hurt; entire arm was sore; This is a spontaneous report received ... Read more
left armpit began to significantly hurt; entire arm was sore; This is a spontaneous report received from a non-contactable consumer, the patient. A 45-year-old non pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to mangos. The patient received loratadine (ALAVERT) for unknown indication and birth control pill within two weeks of vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 03Mar2021 at 11:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not tested for COVID-19, since the vaccination. On 25Mar2021 at 18:00, the patient had experienced approximately 30 hours after vaccination her left armpit began significantly hurt and the entire arm was sore. In the following day morning, her pain had diminished to almost nothing. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events left armpit began to significantly hurt and entire arm was sore was resolving at the time of report. No follow-up attempts are needed. No further information is expected.
45 2021-07-08 tingling my throat started to feel tight; Tingling (pin prick) sensation on forehead, down nose and upper lip... Read more
my throat started to feel tight; Tingling (pin prick) sensation on forehead, down nose and upper lip area; little lightheaded; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via unspecified route administration on 06Mar2021 (at 11:30 AM) as dose 1, single in left arm for covid-19 immunization (at the age of 45years). Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination. Patient did not receive other vaccine within four weeks prior to the COVID vaccine. The patient medical history included Known allergies: latex. The patient's concomitant medications were not reported. The patient had not taken any treatment for reported events. The patient experienced tingling (pin prick) sensation on forehead, down nose and upper lip area, little lightheaded and my throat started to feel tight on 06Mar2021 (at 11:45 AM). The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-07-08 tremor Shake uncontrollably; This is a spontaneous report from a contactable consumer, the patient. A 45-ye... Read more
Shake uncontrollably; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the right arm on 22Mar2021 at 11:45 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and psoriasis. The patient did not have any allergies to medications, food, or other products. Concomitant medication included sertraline (MANUFACTURER UNKNOWN) for an unspecified indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 12:00, within 15 minutes of receiving the vaccine the patient began to shake uncontrollably. The patient was taken immediately to the emergency room. The episode lasted for about 4 hours. After 4 days, she had uncontrollable shaking episodes every day since then and it happened several times a day. The patient was treated with unspecified prescription medication. The event result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of uncontrollable shaking episodes was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
45 2021-07-09 bell's palsy Bells Palsey (right facial dysequilibrium with standing, ambulatoin Headache, cervical trigger point... Read more
Bells Palsey (right facial dysequilibrium with standing, ambulatoin Headache, cervical trigger points
45 2021-07-09 numbness, pain in extremity AFTER 1ST DOSE ON 6/15/2021 I HAD A MILD NUMB SENSATION ON THE TIPS OF MY FINGERS IN LEFT HAND STILL... Read more
AFTER 1ST DOSE ON 6/15/2021 I HAD A MILD NUMB SENSATION ON THE TIPS OF MY FINGERS IN LEFT HAND STILL REMAINING AT TIME OF 2ND DOSE. AFTER 2ND DOSE, INCREASED NUMBNESS ON LEFT HAND AND RIGHT SIDE EFFECTED WITH NUMBNESS AS WELL. NUMBNESS AND A FEELING OF NAILS THROUGH FINGERS COMES AND GOES STILL.
45 2021-07-10 pain in extremity bad headache; left arm soreness; body aches; unable to walk up/down stairs; lower extremity pain/the... Read more
bad headache; left arm soreness; body aches; unable to walk up/down stairs; lower extremity pain/the bottom of feet hurt so bad that it was difficult for me to walk up and down my stairs; bad chills multiple times a day for 6 weeks, and remaining intermittent chills; being in bed for 2 straight days sleeping for 17 hours 2 to 3 days after her first dose; , tinea versicolor rash on her back/arm and after she got the vaccine, the rash "exploded" when she brushed against a weed in the garden causing her arm to blow up; I couldn't lift my arm my arm couldn't touch; joint pain; I experience severe fatigue so much, so I was in bed for two days; when she brushed against a weed in the garden causing her arm to blow up; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via medical information team. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EN6206; Expiration Date: not reported), via intramuscular route, administered in left arm on 13Mar2021 at 16:30 (at the age of 45-year-old) as dose 1, single for covid-19 immunisation. The patient medical history was none. The patient was not taking any concomitant medication. Patient had been seeing a psychiatrist for the past five years and this psychiatrist provides her prescriptions for all of her medications including her ADD medications. Patient stated she never goes to the doctor and she does not see a primary care physician. Patient stated she was in the "really small group of rare side effects for every ADD medication she has ever been on". Prior vaccination before four weeks the patient did not receive any medication. On an unspecified date in Mar2021, the patient experienced multiple adverse reactions including bad headache, left arm soreness that prevented her from touching or raising it, body aches that lasted five weeks, 3 days unable to walk up/down stairs due to lower extremity pain, the bottom of feet hurt so bad that it was difficult for me to walk up and down my stairs, lower extremity pain, bad chills multiple times a day for 6 weeks, and remaining intermittent chills a couple times a week for the past 7 or 8 weeks, being in bed for 2 straight days sleeping for 17 hours 2 to 3 days after her first dose, tinea versicolor rash on her back/arm and after she got the vaccine, the rash "exploded" when she brushed against a weed in the garden causing her arm to blow up, could not lift my arm my arm could not touch, significant joint pain, severe fatigue so much, so she was in bed for two days. The patient stated that she got vaccinated, Saturday 13Mar2021 and her symptom started, she had very typical symptoms severe arm pain. She could not lift her arm and her arm could not touch. She had a headache and then her symptoms really started, Monday, Tuesday, Wednesday and Thursday. 15 ,16, 17 ,18." She had multiple adverse reactions including a bad headache, left arm soreness that prevented her from touching or raising it, body aches that lasted five weeks (including 3 days where she was unable to walk up/downstairs due to lower extremity pain), bad chills multiple times a day for 6 weeks, and remaining intermittent chills a couple times a week for the past 7 or 8 weeks, . Patient also reported being in bed for 2 straight days sleeping for 17 hours 2 to 3 days after her first dose. Patient stated that she had a Tinea Versicolor rash on her back/arm, and after she got the vaccine, the rash "exploded" when she brushed against a weed in the garden causing her arm to "blow up." She experienced severe fatigue so much, so that she was in bed for two days. She had chills, really bad chills and It had been about 14 weeks since she got her vaccination and since after the first six or seven week, she still got chills a couple times a week. It was reported that the second dose was scheduled for 06Apr2021, but she cancelled that and had only first shot because of all of her concerns. Patient stated that done my reaction to my first dose are significant and these were more reactions that people were experience with the booster, their second dose so my doctor concern was that, should not have experiencing such strong side effects to the first vaccine from the first dose and to concerning how I am I react to this second dose and we will wondering if Pfizer, Because My doctor, I am very sensitive to medication like extremely sensitive to medication and because of my size am worried little my doctor doesn't think, I have any business receiving it full dose as the second vaccination we are wondering, If Pfizer can Order a smaller dose of it of the second one. Patient stated she has spoken to her psychiatrist about this and he recommended she call Pfizer to report her symptoms and ask about the second dose. Patient questioned if there was an antibody test she could get to determine if she is adequately protected against Covid-19 from her first dose. The patient asked if her side effects would be considered severe and if she could get smaller dose of the Pfizer BioNTech Covid-19 vaccine as her second dose. Patient did not receive any treatment for the events. The outcome of the events was unknown.
45 2021-07-10 tingling, hot flush Dizzyness/lightheaded; Tingling; Hot cold flashes; Extreme tiredness; This is a spontaneous report r... Read more
Dizzyness/lightheaded; Tingling; Hot cold flashes; Extreme tiredness; This is a spontaneous report received from a non-contactable consumer. This 45-year-old female consumer (patient) reported for herself. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID); esomeprazole sodium (NEXIUM); fexofenadine hydrochloride (ALLEGRA); probiotics (PROBIOTICS) and vitamin c [ascorbic acid] (VITAMIN C) all concomitant medications taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. On an unspecified date, the patient reported that after receiving the first dose, within 5 mins experienced severe, dizzyness, lightheaded tingling, hot cold flashes all lasting 15-20 minutes, the next 24hrs extreme tiredness and arm soreness for few weeks after the 2nd shot. The patient had not been tested for COVID-19 since the vaccination. Treatment was not received for any of the events. Outcome of the events dizzyness, lightheaded tingling and hot cold flashes was reported as recovered. Outcome of the events extreme tiredness and arm soreness was reported as Unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-07-10 tingling Hand and finger tingling; Shoulder pain; Neck pain; This is a spontaneous report from contactable co... Read more
Hand and finger tingling; Shoulder pain; Neck pain; This is a spontaneous report from contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 09:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The patient was not allergic to medications, food, or other products The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 27Mar2021 at 00:00, the patient experienced hand and finger tingling, shoulder and neck pain. No therapeutic treatment was taken for the reported events. The clinical outcome of the events hand and finger tingling, shoulder and neck pain was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-11 nerve pain Nerve pain from neck to fingers in Left Arm, chest pains (chronic), went to see my doctor the follow... Read more
Nerve pain from neck to fingers in Left Arm, chest pains (chronic), went to see my doctor the following Wednesday after my second shot and was diagnosed with a pinched nerve, was referred to physical therapy
45 2021-07-11 pain in extremity Patient had left lower extremity pain x 4 days with left lower extremity swelling x 2 days. Patient ... Read more
Patient had left lower extremity pain x 4 days with left lower extremity swelling x 2 days. Patient diagnosed with an extensive deep vein thrombosis in left lower extremity.
45 2021-07-11 pain in extremity Extreme sore arm?unable to use, Chills Achy all over Extreme fatigue Lower back pain causing difficu... Read more
Extreme sore arm?unable to use, Chills Achy all over Extreme fatigue Lower back pain causing difficult to bend, move, walk Headache
45 2021-07-11 tingling, cold extremities, numbness, muscle twitching WIthin 3 hours of dose administration, observed and felt non-painful muscle "twitching" in both legs... Read more
WIthin 3 hours of dose administration, observed and felt non-painful muscle "twitching" in both legs. Both hands and feet became cold with pallor and Raynaud's phenomenon observed in both hands feet requiring constant rewarming. Approximately 8 hours later, experienced bilateral hand and foot "pins and needles" sensations. Sought medical treatment today 7/12 as symptoms intermittently persist in addition to lightheadedness (feeling as though fainting would occur) and brain fog experienced for 6 hours on 7/3. On 7/10, was awakened from sleep with tachycardia (peak HR 148 lasting 49 minutes as captured by Fitbit wearable device). The following am 7/11, numb sensation felt on L arm with continued "pins and needles " sensations experienced in Bilateral hands and feet. This writer was unable to work that day as a result.
45 2021-07-12 feeling of body temperature change "went from cold to hot, shoulder and back pain" "legs got so dehydrated I couldn't walk" "felt like ... Read more
"went from cold to hot, shoulder and back pain" "legs got so dehydrated I couldn't walk" "felt like I did when I had Covid"
45 2021-07-12 numbness, tingling Immediately after injections- tingling/numbness in left arm/hand. April 25th - numbness in both hand... Read more
Immediately after injections- tingling/numbness in left arm/hand. April 25th - numbness in both hands, neck fatigue, difficulty swallowing, tingling along jaw line, severe upper back pain (thoracic spine), panic attacks, memory issues, severe fatigue. I stopped having a menstrual cycle.
45 2021-07-12 tingling High blood pressure and left side of the chest pain, tingling in the face and tingling tongue . Cont... Read more
High blood pressure and left side of the chest pain, tingling in the face and tingling tongue . Continued on throughout the day, was discharged from the emergency room as a presumed vaccine reaction around 8pm.
45 2021-07-13 pain in extremity Height fever, body pain, nausea, vomiting and headache, sleepiness and tiredness starting 6 hours a... Read more
Height fever, body pain, nausea, vomiting and headache, sleepiness and tiredness starting 6 hours after vaccine, all those resolved after 2 days then Covid Arm, Big red hot patch in arm, itchy and painful and inflammation, started 2 days after the 2nd dose of the vaccine
45 2021-07-14 discomfort Anxiety, nausea, vomiting. Pt. complained of anxiety after receiving the 2nd dose of Pfizer vaccine.... Read more
Anxiety, nausea, vomiting. Pt. complained of anxiety after receiving the 2nd dose of Pfizer vaccine. Pt. observed vomiting clear emesis with mild discomfort. Emergency personnel notified and pt. refused transport for further evaluation.
45 2021-07-14 slurring Tired and slurred speech
45 2021-07-17 burning sensation Developed some weird symptoms in her head, like a burning sensation in nose and sinus of her head/ B... Read more
Developed some weird symptoms in her head, like a burning sensation in nose and sinus of her head/ Burning sensation was reported as worsened; Developed some weird symptoms in her head, like a burning sensation in nose and sinus of her head; Developed some weird symptoms in her head, like a burning sensation in nose and sinus of her head; She kept losing weight since the burning sensation started; She cannot function or go to work; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8734, Expiry date and NDC number was Unknown), via an unspecified route of administration, administered in left arm on 03Apr2021 between 9:00 to 9:30 AM (at the age of 45-year-old) as a single dose for covid-19 immunization. The patient had no medical history. Patient did not administer any concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 13Mar2021 at 9:00 AM (at the age of 45-year-old) as a single dose for covid-19 immunization and did not experience any adverse event. The patient had no family medical history. It was reported after a few days from her second dose, on an unspecified date in Apr2021, she started experiencing a burning sensation on her nose and sinus of her head (some weird symptoms in her head, like a burning sensation in nose and sinus and head). She was really concerned that she had the burning since the second vaccine. She went to a couple of doctors like a neurologist and gastroenterologist. She went to all kinds of doctors trying to figure out why the burning started, it was a neurological problem. She was asking what could cause that. When queried about the weight, she reported that she was 128 pounds and she kept losing weight since the burning sensation started. The doctors did so much blood work and they keep saying she was fine. The burning was not stopped, and she did not know where to go for help. Treatment: First she was given steroids for 5 days and it stopped, then it came back. She was given steroids again a second time and it did not help. Reported the steroids she was given twice was Methylprednisolone She did not have lot, ndc, or expiration date to provide. First time she used the steroid it helped. The second time she was on it the burning started again the next day after she finished the steroid. Patient stated one doctor thought it could be from acid and she took something and it did not stop burning. The neurologist did some blood work and she was told that there was nothing in her blood work that is showing inflammation. She went to ENT and he did not check her nose or sinus. She still did not know the cause. She could not function or go to work. She was losing her head since she could not stop the burning. She went eight times to the emergency room, and they could not find anything and sent her home. She was admitted once and this was the last time she went, told she cannot keep going back to the ER. Events also resulted in physician office visit. The outcome of the event she cannot function or go to work was unknown and the rest of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
45 2021-07-17 pain in extremity Arm ache; aches; fever; lymph ache (in armpit); This is a spontaneous report from a non-contactable ... Read more
Arm ache; aches; fever; lymph ache (in armpit); This is a spontaneous report from a non-contactable consumer, the patient. A 45-years- old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via an unspecified route of administration in the right arm on 26Mar2021 at 09:00 AM (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6199), via an unspecified route of administration in the left arm on 05Mar2021 at 01:15 PM (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced arm ache, lymph ache in armpit, fever and aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of arm ache, lymph ache in armpit, fever and aches was recovered on unknown date. No follow-up attempts are needed. No further information is expected.
45 2021-07-17 pain in extremity Arm soreness for few weeks after the 2nd shot; This is a spontaneous report from a non-contactable c... Read more
Arm soreness for few weeks after the 2nd shot; This is a spontaneous report from a non-contactable consumer or other non-HCP (patient). A 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 45-years-old) as dose 2, single for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, esomeprazole sodium (NEXIUM) taken for an unspecified indication, fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, vitamin c [ascorbic acid] (VITAMIN C) taken for an unspecified indication and probiotics taken for an unspecified indication. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and within 5 minutes experienced severe, dizziness, lightheaded tingling, hot cold flashes all lasting 15-20 minutes, the next 24hrs extreme tiredness. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. After the second shot of the vaccine, the patient experienced arm soreness for few weeks. The patient not received treatment for the adverse event. The clinical outcome of the arm soreness for few weeks after the 2nd shot was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
45 2021-07-18 numbness Sudden onset of left side facial numbness approximately 6 weeks after shot. Progressed to loosing ... Read more
Sudden onset of left side facial numbness approximately 6 weeks after shot. Progressed to loosing taste on left side of tongue and face.
45 2021-07-18 muscle spasms Super light, barely-there period May 16 Missed period June 16 long period July 4 -July 19 and ongoin... Read more
Super light, barely-there period May 16 Missed period June 16 long period July 4 -July 19 and ongoing (16 days and counting).: heavy menorragia with large clots (quarter- silver dollar size) cramping.
45 2021-07-19 burning sensation, hot flush chills; fever; fatigue; face hot to touch; blotchy skin.; Eyes watering; burning of face.; This is a... Read more
chills; fever; fatigue; face hot to touch; blotchy skin.; Eyes watering; burning of face.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unspecified date in Mar2021 at 13:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic and hypothyroidism. The patient had no known allergies. Concomitant medications included metformin (MANUFACTURER UNKNOWN), semaglutide (OZEMPIC) and levothyroxine sodium (SYNTHROID). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. On an unknown date in Mar2021 at 21:30, the patient experienced chills, fever, and fatigue for the first 2 days, hot to touch and blotchy skin on the fourth day. The patient experienced eyes watering from the burning of face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the events. The clinical outcomes of the events chills, fever, fatigue, face hot to touch, watering eyes, skin blotches and burning of face were recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-19 flushing, tingling Immediate flushing and redness on face and neck; Immediate flushing and redness on face and neck; It... Read more
Immediate flushing and redness on face and neck; Immediate flushing and redness on face and neck; Itching; pins and needles feeling on my face mostly but and all over intermittently. Very intense and aggravating; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 28Mar2021 12:45 (Lot Number: ER8730) as single dose (at 45 years old) for COVID-19 immunisation. Medical history included anxiety, known allergies: cats, seasonal allergies and dairy. Concomitant medications included unspecified drugs. On 28Mar2021 12:45, the patient experienced immediate flushing and redness on face and neck, itching, pins and needles feeling on my face mostly but and all over intermittently, very intense and aggravating. The events required a visit to the emergency room/department or urgent care. Therapeutic measures were taken as a result of the events included steroid shot and 72 hours of antihistamines. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021.
45 2021-07-20 flushing, unresponsive to stimuli, flushing, unresponsive to stimuli, unresponsive to stimuli, flushing Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
45 2021-07-20 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
45 2021-07-20 pain in extremity Exhaustion, sore arm
45 2021-07-21 numbness, bell's palsy Mouth was drooping; Swollen lymph nodes; Liver enzymes were abnormally elevated; Cold sores; Arms we... Read more
Mouth was drooping; Swollen lymph nodes; Liver enzymes were abnormally elevated; Cold sores; Arms were numbing when sleeping; Eyes were burning; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0196) via an unspecified route of administration in left arm on 27Jun2021 at 13:00 (at the age of 45-years-old) as first dose, single for COVID-19 immunization. Medical history included anemic and iron deficiency. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jun2021, the patient experienced eyes were burning at night while sleeping they started burning a few days after the vaccine. On 05Jul2021, the patient experienced liver enzymes were abnormally elevated and cold sores. On 07Jul2021, the patient experienced swollen lymph nodes. On 08Jul2021, the patient experienced mouth was drooping. On an unspecified date in Jul2021, the patient experienced arms were numbing when she was sleeping started three or four days ago and last night did not feel the numbing in her arms, she thought it has recovered completely. Patient reported that when she saw her face she thought she had a stroke and rushed to ER. She confirmed that she was not admitted. Therapeutic measures were taken as a result of mouth was drooping (bell's palsy), treatment was received as steroid and an antiviral medication. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date in 2021, computerized tomogram: do not have stroke on an unspecified date 2021, hepatic enzyme: liver enzymes were still elevated on 05Jul2021, magnetic resonance imaging: do not have stroke on an unspecified date in 2021. Patient was told at ER that she did not have a stoke and probably had Bells Palsy. The outcome of events of eyes were burning was recovered on an unspecified date in 2021, arms were numbing when sleeping was recovered on an unspecified date in Jul2021 and the outcome of events mouth was drooping, cold sores was recovering while the outcome of events swollen lymph nodes, liver enzymes were abnormally elevated was not recovered.
45 2021-07-21 pain in extremity Extreme arm pain at rest and with movement. Significant loss of range of motion.
45 2021-07-21 tingling, numbness C/O right sided numbness and tingling was transported to Hospital by paramedics. Was released that s... Read more
C/O right sided numbness and tingling was transported to Hospital by paramedics. Was released that same evening
45 2021-07-21 tremor, tingling, muscle twitching 1 week after my 2nd dose of the Covid 19 Pfizer vaccine I had muscle twitching in my foot that kept ... Read more
1 week after my 2nd dose of the Covid 19 Pfizer vaccine I had muscle twitching in my foot that kept me awake all night. By the following week my muscle twitching increased to almost continuous twitching to both my legs as well as to arms and even stomach, back. Around the 2nd week (early April) post vaccine I also started having shooting and burning nerve pain throughout my entire body. These episodes were frequent and lasted approximately 10 seconds and moved over my entire body including to my neck, back, abdomen, and both bilateral upper and lower extremities. I experienced these shooting/burning episodes at least 6-10/hour all day. I also experienced some weakness to my left arm when trying to lift light weights and had parasthesias to mostly left arm feeling like a tremor and both legs. Additionally my left side of head felt like it had pressure and discomfort. Upon weakness I followed up with MD and had a battery of tests, blood labs, mri of brain and cervcial neck I then was instructed to follow up with a local neurologist, who witnessed the muscle twitching and did an EMG. I wanted another opinion as neurologist was perplexed at what I was experiencing. I made an appointment with neurology clinic but had long wait due to lack of appointments. Prior to seeing neurology clinic, I experienced a few days feeling like I couldn?t take a deep breath and did go to the ER. I was told to follow up with different hospital which I did on July 7th. I was instructed at this time that I should report my symptoms as they all started after the vaccine. I had CT of Chest compLeted since and am awaiting a repeat EMG by MD at hospital. Prior to this I was a active, healthy adult living without pain and working out often. I continue to experience the nerve ;pain which has lessened some but still have the muscle twitching everyday.
45 2021-07-22 flushing Immediately after injection I had an onset of feeling flushed and lightheaded without loss of consci... Read more
Immediately after injection I had an onset of feeling flushed and lightheaded without loss of consciousness. Then my heart rate increased to 150-160 with very frequent ectopic beats for several minutes. I then experienced frequent episodes of tachycardia with heart rates ranging from 160-170 and frequent ectopic heart beats requiring both emergency treatment and medications and 4 months of the inability to work. The tachycardic episodes lasted 6 months and the frequent ectopic heart beats are still persistent.
45 2021-07-22 flushing Rapid heart rate; flushing in body; This is a spontaneous report from a contactable consumer, the pa... Read more
Rapid heart rate; flushing in body; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had unspecified allergies to food, medications or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 24Mar2021 at 12:15, the patient experienced rapid heart rate and flushing in body. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events rapid heart rate and flushing in body was recovered on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-22 tremor, feeling of body temperature change Patient stated she was hot and cold, and dizzy at 3:00pm. Called 911, patient refused to go to hospi... Read more
Patient stated she was hot and cold, and dizzy at 3:00pm. Called 911, patient refused to go to hospital. States she continued to have symptoms of tremors, lower back pain, and fever through the night and went to urgent care. Released and states she is felling better as of 11:00 am 7/23/21.
45 2021-07-25 facial pain Two days after receiving second vaccination came down with illness; headaches, fatigue, ear pain, na... Read more
Two days after receiving second vaccination came down with illness; headaches, fatigue, ear pain, nasal congestion, eyes swollen/red, face pain
45 2021-07-25 migraine Fever migraine, pain in hip, cardia, pulse elevated.
45 2021-07-26 nerve pain canker sore (started 5/24/21)-lasted for about a week or two loss of taste and smell, coughing, tire... Read more
canker sore (started 5/24/21)-lasted for about a week or two loss of taste and smell, coughing, tiredness (started 5/26/21)-as of 7/27/21 has not regained 100 percent sense of smell yet shooting nerve pain similar to shingles affecting right lower side back of head (5/28/21-6/1/21) -started taking ibuprofen on 5/28 for pain
45 2021-07-27 weakness Severe head pain, chest and heart pain, fever, chills, body pain and joints, weakness, sleepiness, s... Read more
Severe head pain, chest and heart pain, fever, chills, body pain and joints, weakness, sleepiness, swelling in the vaccination area.
45 2021-07-27 difficulty speaking Hoarse; Extremely dry throat; Fatigue/tiredness; This is a spontaneous report from a contactable con... Read more
Hoarse; Extremely dry throat; Fatigue/tiredness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8737), via an unspecified route of administration in the left arm on 02Apr2021 at 10:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not have a history of allergies to food, medications, or other products. Concomitant medications included estradiol (ESTROGEN), naloxone hydrochloride; buprenorphine hydrochloride (SUBOXONE) and venlafaxine hydrochloride (EFFEXOR) all from an unknown date and for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021, the patient experienced hoarse, extremely dry throat, and fatigue /tiredness. The patient did not know if having a hoarse and extremely dry throat was normal. Adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events hoarse, extremely dry throat, and fatigue /tiredness was not recovered. No follow-up attempts are needed. No further information is expected.
45 2021-07-27 hot flush I have not had a menstrual period since I received the 1st dose of the vaccine. I had intense hot fl... Read more
I have not had a menstrual period since I received the 1st dose of the vaccine. I had intense hot flashes for several weeks after receiving the vaccine, that have now subsided. My doctor's office ran blood tests to check my hormone levels and they are now at peri and post menopausal levels (depending on the hormone).
45 2021-07-27 hot flush Fever 101; Chills; Hot flashes; Terrible headache; Stomach pain; Nausea; This is a spontaneous repor... Read more
Fever 101; Chills; Hot flashes; Terrible headache; Stomach pain; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 14:00(at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included mental disorder, difficult digestion and allergy to NSAIDS. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 04Apr2021 the patient experienced fever 101, chills, hot flashes, terrible headache, stomach pain and nausea. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, hot flashes, terrible headache, stomach pain and nausea were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-27 numbness, muscle twitching Twitching (face, arms, legs, foot), Weakness/ numbness in hand and legs and arm, headache, heart pal... Read more
Twitching (face, arms, legs, foot), Weakness/ numbness in hand and legs and arm, headache, heart palpitations, fatigue, joint and neck pain, increased anxiety. (Symptoms have been off and on, not constant)
45 2021-07-27 pain in extremity Inside her body is shaking; dizziness; tiredness all day; soreness in her hand; This is a spontaneou... Read more
Inside her body is shaking; dizziness; tiredness all day; soreness in her hand; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0167), via an unspecified route of administration on 11May2021 between 03:00 to 03:30 (at the age of 45-year-old), as dose 2, single in left arm for COVID-19 immunisation at Pharmacy/drug store. The patient's medical history included ongoing hypothyroid problem. Concomitant medication included levothyroxine started taking from last 7 years for hypothyroid problem, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FP7533), via an unspecified route of administration on 20Apr2021 between 03:00 to 03:30 (at the age of 45-year-old), as single dose in left arm for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. On 11May2021, 1 hour after administration of second dose of vaccine, the patient experienced soreness in her hand for a duration of 1 day. On 12May2021, 1 day after the administration of second dose of vaccine, the patient experienced tiredness in the evening for all day. On 13May2021, 2 days after the administration of second dose of vaccine, morning time when she woke up inside her body was shaking and got dizziness; continued even on the 10th day. Patient did not require a visit to Emergency Room or Physician Office. Patient did not receive any treatment for the events. The clinical outcome of event soreness in her hand was resolved on 12May2021, clinical outcome of event tiredness all day was resolving; and clinical outcome of all other events was unknown. Additional information is requested. Follow-up attempts have been completed and no further information is expected
45 2021-07-27 tingling, numbness numbness; tingling in her arm which radiated to her hand.; The injection was maybe 3 inches down fro... Read more
numbness; tingling in her arm which radiated to her hand.; The injection was maybe 3 inches down from her left shoulder. She is not sure if given in the muscle.; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0196) via an unspecified route of administration (age at vaccination 45-year) in Left Arm on 21Jun2021 around 17:00-17:30 or 17:15 as dose 1, single for COVID-19 immunization.Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, upper respiratory tract infection from Nov2019.The patient's concomitant medications were not reported.The patient previously took omega XL and fish oil (6-7 years ago).There was no prior Vaccinations within 4 weeks.On 27Jun2021 the patient experienced numbness and tingling in her arm which radiated to her hand. It was reported that the injection was maybe 3 inches down from her left shoulder. she was not sure if given in the muscle. The reporter was at the pharmacy seeking guidance whether she should receive the second of the Pfizer COVID-19 vaccine or not. She got first shot on 21Jun2021 and on 27Jun2021, her arm and hand in the side it was given became numb and tingly. It was not as bad as it was. Her hand was still tingly. She came to get second shot and pharmacist said she needs to find out if it was ok to receive second dose. The reporter mentioned she doesn't have an HCP and can't afford to go the emergency room because she does not have insurance. She was a CNA. She does not have a primary care provider. She called where she got the shot last Friday past. The pharmacist said they probably hit a nerve or something. Her whole left arm in the beginning was numb for 3-4 days and then just her hand. If she touches fingers together with thumb, she can still feel tingly sensation, but it was not as bad. It felt like when you lay on your hand like when falling asleep. It was not as aggravating as it was. The injection was maybe 3 inches down from her left shoulder. She was not sure if given in the muscle. She thinks she had COVID in Nov2019, and at the time they did not know if it was COVID and called it an upper respiratory infection. On 06Jun2021, she thought she got the new strand and after she got well, she went ahead and got the vaccine because she did not want to get it again. She does not take other medication unless it may be an Advil or Ibuprofen and was not taking any when she got the vaccine. Therapeutic measures were taken as a result of the adverse events. The patient was recovering from numbness and tingling in her arm which radiated to her hand, while the outcome of another event was unknown.
45 2021-07-27 tingling, pain in extremity, feeling cold Leg cramps/pain from knees down to palm of both feet.; Pain in muscle, bone and nerve; Tingling at b... Read more
Leg cramps/pain from knees down to palm of both feet.; Pain in muscle, bone and nerve; Tingling at bottom of feet; Feet were cold could not warm them; Small pain in arms; Fatigue; Joint pain; This is a spontaneous report from a contactable consumer, the patient, A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP9655) via an unspecified route of administration in the arm left on 30Mar2021 at 19:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease or hypothyroidism and food allergy (gluten and soy). Concomitant medications included nitrofurantoin (MANUFACTURER UNKNOWN) started from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 00:00, the patient experienced leg cramps/pain from knees down to palm of both feet, pain in muscle, bone and nerve, tingling at bottom of feet, feet cold could not warm, small pain in arms, fatigue and joint pain. The patient has reported that ER dr. cleared him of deep vein thrombosis, could feel small pangs in my arms, turned into fatigue and joint pain and then after 4 days it has gone at the time of reporting. It was started after 72 hours. The event resulted in emergency room/department or urgent care. It was unknown whether the patient had received any treatment for the reported events. The clinical outcome of the event pain in legs, pain, feeling cold, pain in extremity, paresthesia, fatigue and joint pains was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
45 2021-07-28 discomfort Experiencing discomfort to left underarm/breast area since 7/24/21
45 2021-07-28 feeling hot Moderate swelling of eyelids and surrounding skin; Warmth/inflammation of cheeks and ears; Moderate ... Read more
Moderate swelling of eyelids and surrounding skin; Warmth/inflammation of cheeks and ears; Moderate swelling of surrounding skin; Warmth/inflammation of cheeks and ears; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 05Apr2021 at 13:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune rash and had known allergies to sunscreen and cold temperature. Concomitant medications included dupilumab (DUPIXENT), loratadine (CLARITIN), plantago ovata (METAMUCIL) and fluticasone furoate (FLONASE SENSIMIST ALLERGY RELIEF); all from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 07:00, the patient experienced moderate swelling of eyelids and surrounding skin and warmth/inflammation of cheeks and ears. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of moderate swelling of eyelids and surrounding skin and warmth/inflammation of cheeks and ears were recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-28 muscle spasms Severe leg cramps on the night of the shot; This is a spontaneous report from a contactable consumer... Read more
Severe leg cramps on the night of the shot; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 07:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies, IBS (irritable bowel syndrome) and allergy to flax and NSAIDS. Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA), amitriptyline (AMITRYPTILINE), omeprazole (MANUFACTURER UNKNOWN) and clarithromycin (CLARITT); all from an unknown date for unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 at 23:00, the patient experienced severe leg cramps on the night of the shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event severe leg cramps on the night of the shot was recovered with sequelae on unknown date. No follow-up attempts are needed. No further information is expected.
45 2021-07-28 pain in extremity Arm soreness within 12 hours of vaccination.; This is a spontaneous report from a non-contactable co... Read more
Arm soreness within 12 hours of vaccination.; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01May2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021, the patient experienced arm soreness within 12 hours of vaccination. The clinical outcome of the event arm soreness within 12 hours of vaccination was recovered on an unknown date in May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-07-28 seizure Seizure; Blurry vision
46 2020-12-31 numbness Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated b... Read more
Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated blood pressure. She reports getting the COVID-19 vaccine this morning, and after having been given the vaccine developed elevated blood pressure, palpitations described as "her heart feels hot", shortness of breath, a diffuse rash, and some generalized numbness. Patient called EMS after her symptoms did not resolve on their own, who gave her 50mg of IV Benadryl and transported her to the ED. Received solumedrol and famotidine IV in ED. Erythema noted on neck  
46 2021-01-01 weakness Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driv... Read more
Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driving due to violent rigors. Single episode explosive diarrhea upon arrival home. Patient incapacitated on couch for 3.5 hours due to shaking chills, dizziness, headache, profound weakness, near syncope when attempting to get up. Patient unable to reach phone to summon help for over an hour. (phone was only 2 feet from patient).
46 2021-01-02 difficulty speaking, pain in extremity, tenderness Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for obs... Read more
Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for observation, left on my own. Noticed face was swollen and red after showering- took photo. Cough and clearing throat like when I eat something I?m allergic to. Took another benedryl four hours later as well as Tylenol for headache. Ate dinner went back to sleep notice arm hurts a bit. Next morning 9 am face no longer swollen but arm hurting to the slightest touch. 4:30 pm still resting arm very painful . Headache and facial swelling under control. At no time did I have trouble breathing, slight itching
46 2021-01-02 hot flush, numbness, tingling Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/20... Read more
Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/2021, peripheral tingling or numbness on 1/2/2021. Took 800 mg Ibuprofen BID to help with symptoms,
46 2021-01-03 flushing Turned red and flushed within 5 minutes of vaccine administration. Lasted for about 60 minutes. N... Read more
Turned red and flushed within 5 minutes of vaccine administration. Lasted for about 60 minutes. No issues breathing.
46 2021-01-03 tingling, numbness After the 15 min monitoring, I went back to work 15 min later. the left side of my face started ting... Read more
After the 15 min monitoring, I went back to work 15 min later. the left side of my face started tingling which went to a numbing feeling down the left side of my body affecting my neck, shoulder, arm, elbow and up the upper left torso. My face and neck was numb for about 48 hrs and the rest came back to sensation within 24 hrs. D/T the numbness I was admitted into the hospital for a 24hr observation.
46 2021-01-04 weakness Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no brea... Read more
Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no breathing difficulties, and weakness. Tylenol helped.
46 2021-01-04 weakness tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-lik... Read more
tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was hospital. Medical history included polycystic ovarian diseases from an unknown date. Concomitant medication included metformin, omeprazole, apremilast (OTEZLA). Patient stated she got the vaccine on the 18th. She took the vaccine on 20Dec2020. Yesterday (25Dec2020) she started to feeling sick and today (26Dec2020) patient got tested and she have Covid. She reported to have tested positive for COVID today (26Dec2020) with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms yesterday at around 4:00pm. This was the first time she has taken the Covid test. The physician stated she didn't know the causality between the event and vaccine. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive test for COVID based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
46 2021-01-04 breast pain, burning sensation, feeling cold At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen an... Read more
At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen and tried to go to sleep. I was unable to sleep on my left side as normal. Around 12:30am I woke up cold, shivering violently, with a fever of 103.°3. My feet were also burning. I woke up around 2:30am. Fever was down to about 102.4°, feet were still burning and my face and eyes were swollen. I took more ibuprofen and put used cold compress on my eyes. Around 4:30am I woke up with abdominal pain and pain in my hips. Fever was lower, eyes were better but face still swollen and feet still burning. I called off work at that time. By about 8am fever broke and have just had an intense headache.
46 2021-01-04 burning sensation, pain in extremity Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burni... Read more
Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1685), via an unspecified route of administration on 25Dec2020 at 03:00 PM (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. Medical history included anemia. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfa (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 25Dec2020 at 08:00PM, a fine rash developed on arms and legs. Red, itchy patches on abdomen, back, neck and chin. Hot, burning sensation to palms of hands and soles of feet. The patient did not receive any treatment for the events. The clinical outcome of the events rash on legs & arms, Red, itchy patches on abdomen, back, neck and chin, and Hot, burning sensation to palms of hands and soles of feet was recovered on an unspecified date in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. There were no other vaccines the patient received within 4 weeks of the vaccination.
46 2021-01-04 feeling cold chills; bad headache; body aches; She felt cold; Her arm felt so heavy; This is a spontaneous report... Read more
chills; bad headache; body aches; She felt cold; Her arm felt so heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 46-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), intramuscular in arm right, on 28Dec2020 morning, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from the end of May2020 to unknown date in 2020 (not ongoing) and ongoing hypertension. Concomitant medication included losartan (LOSARTAN) from an unspecified date and ongoing, for hypertension. On 28Dec2020 evening, around 08:00 or 09:00 PM, the patient experienced chills with outcome of recovering, bad headache with outcome of not recovered, body aches with outcome of recovering, she felt cold with outcome of recovering, her arm felt so heavy with outcome of recovered in Dec2020. Therapeutic measures were taken as a result of bad headache and included laying down, ice on her back and neck. The second dose is scheduled on 18Jan2020.
46 2021-01-04 flushing flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (pa... Read more
flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female (not pregnant) patient received BNT162B2 (lot number EH 9899) first dose intramuscularly on right arm on 30Dec2020 09:30 AM at single dose for COVID-19 immunization. Medical history included HTN/GERD, allergies to pineapple and sulfa. Concomitant medications in two weeks included diltiazem (CARDIZEM), valsartan (DIOVAN), omeprazole (PROTONIX), meloxicam (MOBIC), docusate and bupropion hydrochloride (WELLBUTRIN). No other vaccine in four weeks. Patient experienced flushing, chest pressure and lightheadedness on 30Dec2020 09:30 AM, resulted in: Emergency room/department or urgent care and received treatment as ER evaluation. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered in Dec2020. The seriousness was reported as no.
46 2021-01-04 flushing Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day);... Read more
Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day); This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), via intramuscular, on 28Dec2020 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, it's unknown if the patient was tested for COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had SVT, flushing, hives 20 min after receiving vaccine on 28Dec2020. Patient was taken to ED and evaluated. SVT resolved. Patient sent home on heart monitor. Later that night while in bed, heart rate increased to 160's (had been 180's earlier in the day) and patient was admitted to hospital. Patient is a NP. Treatment received for the adverse event included cold water to face, vagal massage. The outcome of the event"Patient had SVT" was recovered on 28Dec2020 and of other events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events supraventricular tachycardia, flushing, hives, heart rate increased cannot be excluded based on the compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
46 2021-01-04 pain in extremity 3 WEEKS POST VACCINE AND ARM MUSCLE/SHOULDER HAS PRETTY SEVERE PAIN. IT HURTS TO RAISE MY ARM ABOVE... Read more
3 WEEKS POST VACCINE AND ARM MUSCLE/SHOULDER HAS PRETTY SEVERE PAIN. IT HURTS TO RAISE MY ARM ABOVE MY HEAD, SHAMPOO/BRUSH MY HAIR, ETC....
46 2021-01-04 tingling Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; Thi... Read more
Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; This is a spontaneous report from a contactable consumer who reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 06:40 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family medical history were both reported as none. Concomitant medications were reported as none. It was reported that history of all previous immunizations was unknown and that the patient had no previous adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any additional vaccines on the same date as BNT162B2. On 22Dec2020 the patient experienced "dizziness", "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face". The adverse events required a visit to the Emergency Room; however, the patient was not admitted to the hospital and was discharged from the Emergency Room. The patient stated that she had a reaction to the COVID-19 vaccine. She reported that she was in the Emergency Room and was still feeling dizzy after being released. The clinical course was reported as follows: "Started off with dizziness, shortness of breath, and then tightness in her throat. Also had blurred vision, and tingling in hands and face. Occurred 25 to 30 minutes after receiving the COVID-19 vaccine. Continuing to experience dizziness that comes in waves after being released from emergency room." The patient stated that she received the vaccine to protect herself and her family. She called to inquire what she could expect, and what her next steps were in terms of the dizziness. She was advised to follow-up with her healthcare provider. It was reported that there were no relevant tests. The clinical outcome of the event "dizziness" was not recovered/not resolved, while the clinical outcomes of the events "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face" were all unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
46 2021-01-05 facial pain 3 days after injection (Thursday 12/24/20)noticed pain and pressure from jaw to ears on left side of... Read more
3 days after injection (Thursday 12/24/20)noticed pain and pressure from jaw to ears on left side of face. Saturday morning (12/26/20) noticed left lymph node was swollen. Sought medical care-DX anterior cervical lymphadenopathy.
46 2021-01-05 feeling cold c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to even... Read more
c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to event. 0900 - bp 126/70, hr 107, rr 20, sats 100 0905 - bp 122/67, hr 90, rr, 18, sats 100 0910 - bp 113/66, hr 81, rr 20, sats 100 - lightedness no longer present, she c/o of being cold, 0915 - dry throat that water helped. denied throat itching, states breathing wnl. 0915 - bp 120/80, hr 88, rr 20, sats 100 Pt reports that she feels better. She is off work today, but she will stay in the rt office with staff for 30 minutes before going home.
46 2021-01-05 feeling hot, burning sensation About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever a... Read more
About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever and some chills, along with body aches. I felt nauseous. I started feeling cramping in my stomach. Yesterday, my temp was just 99.4, face was really red. Felt over heated all day long. When they gave me the shot, after 20 mins I could feel my right nostril burning, and like I could taste a metal taste and taste the actual shot. At 9am, my temp was 100. I took a tylenol.
46 2021-01-05 feeling jittery, tremor Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms... Read more
Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms earlier and worse than usual. EKG showed PVCs.
46 2021-01-05 flushing Dizziness, flushing
46 2021-01-05 numbness, tingling states 40 minutes after her vaccine she developed facial parasthesias and numbness that eventually ... Read more
states 40 minutes after her vaccine she developed facial parasthesias and numbness that eventually resulted in an "ache". No muscle weakness. This has since improved.
46 2021-01-05 numbness Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of ... Read more
Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of right toe. Blood pressure and heart rate mildly elevated beginning around 10:40 pm 1/5/21. Spoke with a triage nurse twice late pm 1/5/21 and early am 1/6/21. Advised self monitoring. Unable to sleep more than about 1 hr at a time-woke up sweaty. No temp. Woke up without dizziness/nausea but had dizziness when eating cereal and looked down. Saw general practice physician 1/6/21 after 10 am 1/6/21. Given anti-dizziness med. prescription. Dizziness/nausea, Tired/heaviness in legs gone when saw physician. Still mild altered sensation in right leg and big toe numbness that comes and goes. Elevated blood pressure at physician. Bloodwork ordered and scheduled for Saturday.
46 2021-01-05 tingling, numbness, weakness muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; he... Read more
muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus. Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.
46 2021-01-05 tingling, muscle twitching, numbness Received the vaccine in morning: Started developing itching on torso throughout the day. On 1/6/20... Read more
Received the vaccine in morning: Started developing itching on torso throughout the day. On 1/6/2021 starting at 0500, the opposite arm (Right) developed tingling and numbness. Thumb is twitching.
46 2021-01-05 tingling Left arm heaviness with tingling.
46 2021-01-06 weakness 12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to inj... Read more
12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to injection site, body aches, lymph node swelling. 36 hours after, still have piercing headache, fever, body aches, lymph node swelling, weakness, on and off chills and dizziness.
46 2021-01-06 discomfort Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right ar... Read more
Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right arm) limiting the use of this arm and causing excruciating pain and discomfort.
46 2021-01-06 slurring, weakness, tingling Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body a... Read more
Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body aches, fast heartbeat. Speech slurred, jaw locking. Taken to ER where she works.
46 2021-01-06 feeling hot, numbness, muscle spasms jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around he... Read more
jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around her mouth went numb; heart palpitations; I had hives on my chest; a wave of heat rush up her back; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 22Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included ectopic pregnancy, hay fever. Concomitant medication received within 2 weeks included: loratadine, colecalciferol (vitamin D), olly womens multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. About 15 minutes after the vaccine the patient experienced jaw tightening and muscle spasms. The patient was given oral Benadryl 50 mg. About 5 minutes after taking the Benadryl, her entire face and around her mouth went numb. The patient began having heart palpitations and felt a wave of heat rush up her back. She had hives on her chest. The patient received 1 dose of epinephrine from an Epi-Pen and transported to the emergency room for further treatment. Adverse event start date: 22Dec2020 11:00 AM. Events were considered as non-serious. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event included: Benadryl, Epinephrine, Solumedrol, Pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name: SARS-CoV-2 by PCR (Nasal Swab) on 30Dec2020: Negative. Outcome of the events was not recovered.; Sender's Comments: The temporal relationship is suggestive of an acute anaphylactic reaction. Based on the temporal relationship and the known pattern of response, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-01-06 muscle twitching Lower lip twitching
46 2021-01-06 pain in extremity Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had... Read more
Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had to use my inhaler, take cold/cough medicine to help me stop coughing. By Wednesday Had a bad cough, tightness in the chest, and lots of congestion. Left arm was very sore. Called work who told me to go to the ER for covid test. Tried to get into my doctor's office who would not see me and told me to get a covid test. Tried to get into Facility who told me I would require two appointments. One to see a doctor and another to get a Covid test. Also, it would be a three to four-hour wait. Felt so sick that I took myself to an ER in order to be seen. Mysaturation was good in the ER but HR was in the 120s. They did an EKG, gave me an albuterol inhaler, IV fluids, IV steroids, and a chest X-ray. They did a Covid test which was negative as well as other bloodwork. Then sent me home. My husband also started with a cold the Sunday night before my vaccine so I do not know if that might have been where I got sick?
46 2021-01-06 pain in extremity Sore arm- lasted 3 days. Moderate intensity Fatigue- 24 hours Nausea and dizziness-2 hours
46 2021-01-06 pain in extremity I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on... Read more
I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on the 3rd and 4th day, I had chest pain radiating to left arm and jaw. Fever and chills reported 100.2 in fever. Severe right arm pain. I have difficulty lifting objects. I have recovered from the chest pain and abdominal pain but the arm pain is still bothersome and continues to be hurtful.
46 2021-01-06 tingling Dizziness Left leg tingling intermittingly, BP163/107 HR 75, BP110/119 HR79 O2 98%
46 2021-01-06 tingling Having pins and needles in left hand, today having it in right hand as well, no treatment at this ti... Read more
Having pins and needles in left hand, today having it in right hand as well, no treatment at this time still having symptoms this morning at time of report
46 2021-01-07 difficulty speaking she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratc... Read more
she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratchy throat, swelling sensation of the throat, hoarse voice, difficulty breathing. Presented to the ED. Received IM Epi, IV Benadryl and Solumedrol.
46 2021-01-07 facial paralysis Headache, Fatigue- on day 2 Bels Palsy- Day 4
46 2021-01-07 feeling cold, pain in extremity With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I co... Read more
With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I couldn't get warm, I felt very tired. About the next thirty hours I had body ache and head ache my arm got very heavy and hurt, I did not run a fever but felt very restless and achy. I was very tired and didn't work the following day, didn't have much of an appetite. I had some mild itching on my arm.
46 2021-01-07 feeling jittery Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feelin... Read more
Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feeling jittery and shaky. Oxygen saturation remained normal. Vital signs normal.
46 2021-01-07 flushing Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Fa... Read more
Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Facial flushing accompanying rash Severe body and joint aches appeared 18 hrs post-injection - responsive to ibuprofen-still present Severe headache appeared 16 hrs post-injection - responsive to Excedrin/Tylenol - still present Low-grade fever 100.1F (taken 3 hrs post ibuprofen)
46 2021-01-07 numbness, tingling The next day after receiving the Covid vaccine injection in my left arm, I had the typical muscle pa... Read more
The next day after receiving the Covid vaccine injection in my left arm, I had the typical muscle pain. That subsided within a day or two. But I am experiencing numbness and tingling throughout the entire length of my arm. It is not severe and I am still able to conduct my work and daily chores, but it is very concerning to me. It is now 5 days later, and the numbness is not any better. My left pinky finger is the worst out of all of my digits. I'm not sure if they somehow hit a nerve during the injection or if this is a side effect of the shot.
46 2021-01-07 pain in extremity left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, sli... Read more
left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, slight fatigue started 12 hours after my second Pfizer dose, better with ibuprofen.
46 2021-01-08 numbness Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating ... Read more
Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating joint pain, chills leading to rigors. No fever. Incapacitating.
46 2021-01-08 night sweats Fever, chills, night sweats, swollen glands under arm, swollen injection site, body aches, headache
46 2021-01-08 pain in extremity Myalgia, NauseaVomiting, Left Arm pain, fatigue, sharp muscle pain, nausea Narrative: Rest, fluids,... Read more
Myalgia, NauseaVomiting, Left Arm pain, fatigue, sharp muscle pain, nausea Narrative: Rest, fluids, Tylenol and Motrin at home
46 2021-01-08 pain in extremity 1st Day- Arm Neck Pain 12/31/2020 Loss of Appetite, Dizzy-current
46 2021-01-08 pain in extremity Dizziness, NauseaVomiting, right arm mild soreness Narrative: 12/29 employee reports onset of dizzi... Read more
Dizziness, NauseaVomiting, right arm mild soreness Narrative: 12/29 employee reports onset of dizziness and nausea about 2 hours after the vaccine. Her right arm is slightly sore. 12/30 - symptoms have improved and are very slight today. 12/21 resolution of all symptoms.
46 2021-01-08 tremor 01/07/2021 8:30PM-1st chills- Uncontrollable shaking for 2-3 hours.(felt like I was running a marath... Read more
01/07/2021 8:30PM-1st chills- Uncontrollable shaking for 2-3 hours.(felt like I was running a marathon in bed) Temp 99.5 9:30PM-Temp of 101 then it went to 102 within an hour. Headache. 10:30 took Tylenol 11:30 Temp 101.5 stopped shaking but still have a temp and muscle aches- probably from the shaking. 12:30 (01/08/2021) Temp 101. Fell asleep 4:30 Temp 100 8:30 Temp 99.5 Still have a headache and muscle pain, and upper back pain Tired, but probably just from roller coaster ride. 01/08/2021 Most of the day and night had low grade fever 99.5-100.7 , headache and sweats 01/09/2021 No Fever, but still have the occasional seats and dizziness
46 2021-01-09 feeling hot, difficulty speaking 15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could fe... Read more
15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could feel my pulse escalating. Nurse in the post-shot monitoring tent took vitals to confirm pulse at 95, when typically 68. I was laid down and BP dropped to 110/78. Chest tightness that I am familiar with from asthma started to develop and my neck and throat and upper shoulders felt very tight and constricted. I had some trouble swallowing water as though my throat was constricted and my breathing felt shallow. Nurses provided care and I was asked to get up and sit in a chair again. Within a minute, I felt dizzy and disoriented again and heart rate went up. The tightness in my chest and throat and shallow breathing continued along with my voice becoming hoarse. The doctor on call asked if I?d had these symptoms before and I said I had after eating shrimp years ago. He decided to transfer me to the ER for monitoring . I stayed at the ER for about an hour and a half and was monitored. The constricted throat and asthma chest tightness did not subside but did not get worse. Doctor recommended Benadryl every 6 hours as symptoms persisted. Within a half hour of taking 25 mg of Benadryl, I started to feel improved breathing and less throat constriction and easier swallowing. After the second dose of Benadryl, symptoms were much 70% gone, except for hoarse voice abs very slight tightness with swallowing. I had informed the injection staff prior to receiving my vaccine that I am a person with a history of anaphylaxis (not to a vaccine) that required and epi pen and overnight hospital stay in the past .
46 2021-01-09 feeling hot Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway con... Read more
Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway constriction but on the outside). Severe heartburn, burping and reflux, anxiety, slightly elevated heart rate about 30 mins after injection, lasting about 30 mins. 5 hours after injection, after eating a small snack, repeat of heartburn, burping and reflux. Felt hot but temperature 97.7, then chills briefly. Anxiety and related fast heart beat and shallow breathing for about 1 hour. Took benadryl, no change.
46 2021-01-09 nerve pain, pain in extremity Symptoms started 2 days after vaccine administration. Started on the right arm (opposite of injectio... Read more
Symptoms started 2 days after vaccine administration. Started on the right arm (opposite of injection), radiates to the right neck and fingertips. Neuropathic, worse at night. Improves to a 3/10 with ibuprofen. No weakness/sensory loss.
46 2021-01-09 pain in extremity Arm soreness, myalgia, fever, fatigue
46 2021-01-09 tingling 14 hours post vaccine began having tingling, pins and needles type sensations in feet, arms, hands, ... Read more
14 hours post vaccine began having tingling, pins and needles type sensations in feet, arms, hands, occasionally trunk
46 2021-01-10 weakness, hot flush Headache, malaise, fatigue, dizziness, weakness, chills and hot flashes
46 2021-01-10 weakness, migraine, hot flush Migraines, body ache, malaise, fatigue, weakness, chills, hot flashes
46 2021-01-10 flushing Erytema with facial flushing on neck and face, Nauseas, no vomit, No dyspness, no shortness of brea... Read more
Erytema with facial flushing on neck and face, Nauseas, no vomit, No dyspness, no shortness of breath. treatment Benadryl IV = Solumedrol + Famatidine IV
46 2021-01-10 migraine, hot flush Headache, NauseaVomiting, Migraine, eye twitching, hot flashes Narrative:
46 2021-01-10 pain in extremity, weakness, migraine Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the v... Read more
Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the vaccine arm, headache, and feeling ache. Day 1 post vaccination patient experienced sore arm, headache, low grade fever, feeling ache, and GI symptoms with diarrhea. Day 2 post vaccination patient experienced sore arm, Migraine, and diarrhea. Day 3 post vaccine patient woke up with chest pain that radiated into her left arm and some weakness. Patient's blood sugar was >500 and was admitted to hospital for DKA.
46 2021-01-10 pain in extremity, cold sweat About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: lik... Read more
About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: like felt like rushed through my body and then instantly my heart started racing and I felt it thump into my throat. Let nurse in attendance know and she took me to another area secluded from others and told me to relax. Sat down. Hooked me up to monitors; blood pressure cuff and finger pulse and she left to go get someone and she brought EMT back with her. Felt tight in chest; in neck felt like there's tightening; but could still breathe; felt heavy: chest. Neck felt tight. Felt like I needed an inhaler. I don't have it with me as I only have asthma in spring and fall. They kept telling me to calm down and I wasn't feeling nervous. I was trying to relax. EMT asked questions and he said that the same thing happened to him. He told me I couldn't leave Event Center until things calmed down for me. Released her when I felt fine but was just really tired and kind of shaky. I felt so exhausted. Told EMT that and he told me he would feel that way if he had just ran a marathon. I had slept 12 hours the night before. He didn't tell me what my heartrate went up to. I left event center at 9:49 pm. Started feeling strange again when doing errands and was at store afterwards (about 30 or 40 min later) - nauseous; dizzy; sweaty, clammy. Heart was racing again. I told husband I didn't feel right. Felt like I needed to sit because I was shaky. Left and went to vehicle. As we sat in car, I told him something wasn't feeling right. Mouth was so dry. He started driving. I felt like we were driving down a tunnel.Husband looked at me and said you don't look right either. Took me to ER in nearest hospital: blood pressure high; heart rate elevated; ER (Hospital) The doctor did lab work. Triponin levels elevated; potassium levels low - sign of a heart episode and needed to get in control. Gave me potassium and took more blood work and troponin levels started coming down. Dr advised me not to go back to get second dose. Personal Care Dr confirmed that I shouldn't get the 2nd dose - put in my records that I am allergic to this vaccine. The next day I had severe diarrhea and terrible pain in my arm that went all the way down and up into my neck and whole right side head hurt. (really bad headache). Extreme fatigue. Went back to work on the following Monday evening and was exhausted doing my job. When I say family Dr on Tuesday, I didn't want to be taken off work because I was in the right place where people could take care of me and I'd taken time off at holidays. That entire week was a lot of exhaustion and tiredness.
46 2021-01-10 pain in extremity 01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vacci... Read more
01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vaccine 01/09 body aches, headache couldn?t move neck due to stiffness; 01/10 left arm soreness, armpit pulsation, fever range 102 F,; 01/11 vomiting. seasonal allergy eye drops for right eye swelling (went away), Benadryl 50 mg.; ibuprofen and Tylenol around the clock starting 01/09 to present day, 01/11/2021
46 2021-01-10 pain in extremity Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain... Read more
Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain. Patient now knows she was exposed before receiving vaccine.
46 2021-01-10 tingling, feeling cold Patient is a 46 yo I female with no sig PMH who reports the onset of fever, body aches and chills on... Read more
Patient is a 46 yo I female with no sig PMH who reports the onset of fever, body aches and chills on Saturday 1/9 after receiving dose#2 of the Pfizer COVID Vaccine on 1/8 24 hours prior. Her temp went up to 100.4. She took Tylenol and motrin with subsequent resolution of symptoms except some slight body aches and the onset yesterday of bilateral stocking like paresthesia in LE's. As the body aches improved, she noticed the paresthesias more although they have lessened somewhat today. No prior history of COVID. Allgergies: NKA Meds: as above SH: Tob: none. ASSESSMENT Vaccine Reaction to COVID. PLAN Follow up with OMS tomorrow or prn.
46 2021-01-10 tingling One week after administration, I had sudden onset inability to move left arm. I was transported to E... Read more
One week after administration, I had sudden onset inability to move left arm. I was transported to ER immediately. Treated, scanned with CT of brain, MRI of brain, c-spine and brachioplexus. In hospital for 2 days and no answers. Still no answers to left arm paresthesia and proprioreceptor deficits. Spreading into left leg and mild systemic symptoms. I have been to the ER, seen by primary physician, Physiatrist and Neurology and Occupational Therapy. I am scheduled for many more appointments and trying to find and answer.
46 2021-01-10 tingling Golf ball size lymph node in left axilla, mild tingling in left arm
46 2021-01-10 tingling The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID... Read more
The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID vaccine (first dose). The HR was checked and marked to be 110bpm. The pt then began to experience tingling at the injection site as well as in the lower bilateral extremities. The pt was escorted to the holding area to lie down on the stretcher. VS checked (139/89 BP, HR 95, Temp 98.4, O2Sat 100%.). Dr in the ACC was called to assess and observe the patient. No further recommendation for treatment was given. Patient was observed for a total of thirty minutes. HR remained within normal limits and pt was cleared to be discharged to home safely. Pt ambulated to personal vehicle with nurse escort.
46 2021-01-10 tenderness, pain in extremity About 6 hrs after receiving the Pfizer-BioTech COVID-19 Vaccine my left arm was sore and my left leg... Read more
About 6 hrs after receiving the Pfizer-BioTech COVID-19 Vaccine my left arm was sore and my left leg, from the knee down was very achy, along with some swelling behind my knee. The next morning my leg did not ache but was very tender to touch, swollen and as of today (3 days later) it is still tender and swollen.
46 2021-01-11 weakness Pain, numbness, weakness in arm opposite site of injection. Time line regarding possible adverse e... Read more
Pain, numbness, weakness in arm opposite site of injection. Time line regarding possible adverse event from COVID 10 Vaccine Dec 21, received COVID-19 Vaccine #1 in right arm lot #EH9899 Dec 23- mild pain in left shoulder, did not do anything that I could pinpoint as the cause of this, no injuries, falls or accidents Dec 24, pain intensified Dec 28, 2020- went to primary MD for exam, gave several medications and ordered an MRI of C-spine which was completed on this day. Dec 29- pain has continued to intensify, now shoulder, and entire left arm. Fingers on left hand intermittently numb except for pointer finger that stays numb, and hand is colder than right hand Dec 29, 2020- results of C-Spine showed no significant issues. Small herniation in one of the disks. Per MD, ?more suspicious of a muscular issue or something external to spine pinching that nerve?. Pain has continued despite medications ordered. Dec 30, 2020 MD referred me to a Neuroversion for pain control. I did not want to go here yet, I wanted to know what was causing the issue, not just treat the pain, decided to wait to make this appointment and instead get an appointment with a Neurologist on Monday due to offices being closed on New Year?s Eve. January 4, 2021 pain, numbness and now weakness have persisted all weekend, appointment with Neurologist scheduled for Tuesday January 5, 2021. January 5, 2021, appointment with Neurologist, suspecting Parsonage-Turner Syndrome. Parsonage Turner syndrome (PTS) is characterized by the sudden onset of shoulder and upper arm pain followed by progressive (worsening over time) weakness and/or atrophy of the affected area. The pain is felt along the path of one or more nerves and often has no obvious physical cause. The network of nerves involved in this syndrome is called the brachial plexus and it controls movement and sensation in the shoulders and arms. The cause is still unknown (idiopathic). However, researchers believe that most cases are due to an autoimmune response following exposure to an illness or environmental factor. Suspected triggers include viral and bacterial infections, surgery, vaccinations, injury, childbirth, strenuous exercise, certain medical procedures, and various health conditions. Treatment is symptomatic and may include pain relievers, corticosteroids and physical therapy.[1][2] January 6, 2021- MRI of left shoulder completed January 8 2021- Follow up of MRI with neurologist. No abnormalities seen on MRI, ruled out any other tumors, or anatomical issues causing pain. Diagnosis Parsonage-Turner Syndrome. Increased dosages of current medications and added another to control nerve pain. January 9, 2021- pain seems to be lessening, numbness and weakness continues January 10, 2021- significant pain returned, numbness and weakness continues. I did get the 2nd dose of the COVID-19 lot # EJ1685 in R arm vaccine today, as MD did not advice against it and I still believe that the vaccine is important.
46 2021-01-11 feeling cold, tingling Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is... Read more
Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is really cold; Caller is continuously coughing during the call.; Fever; Headache; joint and muscle achiness all over; joint and muscle achiness all over; Tiredness; joint and muscle achiness all over, it started in her right arm where she received the injection; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), intramuscularly in right arm on 05Jan2021 around 1315-1320 at single dose for covid-19 prophylaxis in hospital and vaccine was not administered at Military Facility. Medical history included ongoing asthma diagnosed as a child, leaky valve closed up in her heart from 2020 to an unknown date. Family medical history included her mother had Covid over around May2020 and the mother was positive for quite sometime and had to take 3-4 tests, her son had tested positive for Covid and the patient had been around him a little bit. Prior Vaccinations (within 4 weeks) were none and adverse events following prior vaccinations were none. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BRIO INHALER) at 200/25 once a day by inhalation, nebulizer by inhalation every 4 hours as needed, salbutamol sulfate (PROAIR) at 2 puffs every 4 hours when needed, montelukast at 10mg every evening by mouth, all ongoing for asthma. The patient received the Covid-19 vaccine yesterday 05Jan2021 and reported that on 05Jan2021 she has had tiredness, headache, joint and muscle achiness all over. On 06Jan2021, she had fever and chills. She said that she was really cold. She also had a little tingling under her lip and chin area, but it is resolved. She stated that this was this morning 06Jan2021. She said that she did not have the physician details to provide at this time. She said that she had only seen this doctor once on a virtual appointment. She said that tiredness started around 1830-1900 05Jan2021. Headache started 05Jan2021 around when she got off of work at 1500. For event fever, she took her temperature 3 different times, it was at 101.2, then she had a temperature of 102. She last checked it about a half an hour ago on 06Jan2020. For event joint and muscle achiness all over, it was noticed the achiness around 9-10 pm 05Jan2021, she said that it started in her right arm where she received the injection, then moved down to her legs and her back. She stated that it was worse and when she went outside. For chills it started this morning on 06Jan2020 when she was still in bed before she got up at about 0500. She said that she called out of work. This was her first dose of the vaccine. Her next dose is supposed to be on 26Jan2021. The patient was continuously coughing during the call on 06Jan2020. The fever, joint and muscle achiness all over were worsened. The adverse events did not require a visit to emergency room or physician office. The outcome of tiredness, headache, fever, chill, joint and muscle achiness all over, it started in her right arm where she received the injection, were not resolved, outcome of the tingling under her lip and chin area were resolved on 06Jan2021, outcome of she was really cold and cough were unknown.
46 2021-01-11 flushing, feeling hot Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brai... Read more
Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brain fog, chest red 1425 - bp 95/64, hr 82, rr 20, t 97.7, sats 98 1428 50 mg po Benadryl given 1432 - bp 118/68, 1440 - pt reports I am feeling better but it does come in waves. chest remains red 1445 - bp 112/74, hr 70, rr 16, sats 98. Pt reports fine to go home. does not live alone.
46 2021-01-11 numbness, pain in extremity Pain and numbness in her arm, fever
46 2021-01-11 migraine Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headach... Read more
Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headache that worsened to a severe migraine throughout the day. Also that afternoon, developed sores/ulcers inside of mouth. Next day developed worsening sores in mouth and then my tongue began to swell and then noted sores on my tongue as well. This improved with Benadryl over the next 36 hrs.
46 2021-01-11 numbness and pain in extremities, burning sensation, pain in extremity, numbness, tingling #2 vaccine on 1/4. She had side effects beginning that night, started with HA, body aches, fatigue,... Read more
#2 vaccine on 1/4. She had side effects beginning that night, started with HA, body aches, fatigue, scratchy throat. Over next 2 days pain back of legs, which then evolved into burning and then numbness of palms of hands, soles of feet. Reported to me on 1/8. Over last 3 days, she has had slow improvement with slight tingling and numbness fingers. Over weekend, I had her get tested for COVID - both rapid and PCR neg. She went to ED for testing, and they also ran CT head and labs -- negative. She made appt with neurologist today and will follow up with her PCP. Testing for COVID was to rule out as cause for peripheral neuropathy. Might be due to vaccine vs some other undiagnosed condition including autoimmune. Due to the unique nature of this complaint, may be considered Adverse Reaction
46 2021-01-11 pain in extremity, tingling 1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-t... Read more
1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-took tylenol and benadryl 1/7/2021, 6:30 AM, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore, called into work 1/7/2021, 10:20 am, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore-took benadryl and tylenol 1/7/2021, 1:15 PM, very fatigue, fever, body aches, upset stomach, right ear throbbing, fever 100.6-employee health notified, was advised to self monitor for 48 hrs and if no improvement to be tested for COVID on 1/9/2021 1/7/2021, 7:27 PM, completely exhausted, on going headaches, chills off and on, body aches, decreased appetite-tylenol taken 1/8/2021, 10:02 AM, headache, body aches, arm swollen and very painful, the pain traveled to the armpit, felt about 60 % better this day, but still fatigue Symptoms remain the same for the day of 1/8/2021 1/9/2021, 9:38 AM, lingering headache, arm and armpit sore; otherwise, feel much better 1/10/2021, 7:27 PM, Felt much better this day, just little fatigue and arm soreness; otherwise not further symptoms.
46 2021-01-11 pain in extremity Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizzin... Read more
Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 31Dec2020 at 15:30 as a single dose for COVID-19 immunization. Medical history included allergy to tomatoes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 21:00, the patient experienced soreness in my arm, dizziness, tiredness and overall not feeling well. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness in my arm, dizziness, tiredness and overall not feeling well were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
46 2021-01-11 pain in extremity Red, swollen, slightly warm, slightly tender to pressure, small lump about three fingers below right... Read more
Red, swollen, slightly warm, slightly tender to pressure, small lump about three fingers below right deltoid injection of 2nd dose noticed on 1/12/21 at 05:30 which is 4 days post dose. No advert issues or need for medication treatment.
46 2021-01-11 pain in extremity Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral ... Read more
Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral foot pain. Day three moderate bilateral foot pain, all joints have pain, hands and feet the worst. Day four: fatigue (decreased), all over joint pain mild to moderate (went home from work) fatigue. Day Five (today) continued bilateral feet and hand joints mild pain that increases with pressure (walking holding or opening anything causes increase in pain from mild to moderate.
46 2021-01-12 electric shock sensation Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a sho... Read more
Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a shocking sensation around my throat then I had some palpitation.I better about 20 minutes latter. I had prednisone at home, so I took 40mg and Benadryl and PepciI felt I had some sensation of throat tightness the day after that but it went away after few hours.
46 2021-01-12 feeling hot Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very wa... Read more
Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very warm). At about 1:45am on 1/13/2021, was feeling very achy and uncomfortable, so I went downstairs to get some Tylenol. Rapid heart rate and sweating, so much I had to sit down in the kitchen for a few minutes. Eventually took the Tylenol, and as I was heading back upstairs, I passed out (I don't remember going down to the floor) and dropped the cup of water I was taking with me. Was out for less than 30 seconds. A couple episodes of heaving/vomiting small amounts of liquid while on the floor. Made it back to bed and was starting to feel improved around 4:00am.
46 2021-01-12 pain in extremity Headache fever fatigue severe pain cough earache sore throat sore arm. Sore arm day after shot for ... Read more
Headache fever fatigue severe pain cough earache sore throat sore arm. Sore arm day after shot for 3 days. Fatigue day after for 5 days all other sxs started day 5 and still continue
46 2021-01-12 pain in extremity Right arm is sore the following day. When i got home from work (1/13/21) took a shower and i was fee... Read more
Right arm is sore the following day. When i got home from work (1/13/21) took a shower and i was feeling the area where i got the shot and when i raise my right arm i notice under my armpit is swollen.
46 2021-01-12 tingling Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tin... Read more
Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tingling around area of right ear and hearing changes on right side. Numbness in arms/fingers. Symptoms presented about 6 days after 1st vaccine , worsened. Persisted for about 5 days.
46 2021-01-13 discomfort following initial vaccine 12/28, got extremely bloated with joint tightness, fluid overload, inflamm... Read more
following initial vaccine 12/28, got extremely bloated with joint tightness, fluid overload, inflammation, overall discomfort, back pain which radiated to the front of the chest lasting x3 days, took Tylenol. now resolved
46 2021-01-13 flushing flush, rash to face, trunk, and generalized to bilateral lower extremities , intense itchiness, thr... Read more
flush, rash to face, trunk, and generalized to bilateral lower extremities , intense itchiness, throat itchiness and was given Benadryl 25mg IM and took 20 -30 minutes to relieves the itching and hives subsided gradually
46 2021-01-13 flushing Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all ... Read more
Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all over body, no visible hives, flushed-Medium; symptoms lasted 0 days
46 2021-01-13 migraine, pain in extremity Received vaccine 1/13 at noon. Woke up with a migraine level headache about 3am along with a fever... Read more
Received vaccine 1/13 at noon. Woke up with a migraine level headache about 3am along with a fever of 101.6. My right arm is very sore/tender. I have generalized aches.
46 2021-01-13 migraine Severe, intractable daily migraine headaches that escalate throughout the day; This is a spontaneous... Read more
Severe, intractable daily migraine headaches that escalate throughout the day; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received bnt162b2 (BNT162B2) lot no: RH 9899, via an unspecified route of administration in left arm on 16Dec2020 at a single dose for Covid-19 immunization in hospital. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Concomitant medication included vilazodone hydrochloride (VIIBRYD), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), lamotrigine (LAMICTAL), trazodone, and lorazepam (ATIVAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 17Dec2020 06:00, the patient experienced severe, intractable daily migraine headaches that escalate throughout the day and do not respond to any treatment, medicinal or non medicinal (unspecified). The event was reported as non-serious. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not recovered from the event. The patient received another bnt162b2 dose (lot no: EK 4176) on 06Jan2021 in left arm. Information on the batch number has been requested.
46 2021-01-13 pain in extremity, numbness Right side of face is numb; Tingling in lips; Ear feels plugged, like there is water in it or poppin... Read more
Right side of face is numb; Tingling in lips; Ear feels plugged, like there is water in it or popping on an airplane; Severe arm pain; This is a spontaneous report from a contactable consumer reporting for self. This 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 06Jan2021 at 13:20 at single dose in right upper arm for COVID-19 immunisation. Medical history was none. Concomitant medications included ascorbic acid (VITAMIN C) and ibuprofen. The patient got the flu shot every year for immunisation, and got arm pain with the flu shot. No prior vaccinations within 4 weeks. The patient received Pfizer COVID-19 Vaccine on 06Jan2021, at 13:20. By 15:30-15:45, the right side of her face was numb. Had tingling in her lips. Stated the experience was similar to the feeling of receiving procaine hydrochloride (NOVOCAIN) or similar to the feeling when procaine hydrochloride begins to wear off. Her ear was plugged like she was on an airplane. Sated feels like she has water in her ear or like her ear is popping on an airplane. The whole right side of her face was doing something funny. Her lips began to tingle first, then face went numb, then her ear clogged. She talked to an ER physician who advised her to take a diphenhydramine hydrochloride (BENADRYL). ER physician stated these side effects are being seen. No further details provided. Clarified did not require ER Visit, just talked to an Emergency Physician and explained symptoms. She took diphenhydramine hydrochloride at home and the numbness and tingling went away after a couple hours. Her ear is still plugged today. Everything was echoing in her head and it was driving her crazy. Stated she also experienced severe arm pain happened evening of 06Jan2021. Arm pain in only in injection arm. Outcome of right side of her face was numb and tingling in her lips was recovered, outcome of ear feels plugged was not recovered, outcome of other event was unknown.
46 2021-01-13 pain in extremity Headache; Left arm pain near injection site; Fatigue; This is a spontaneous report from a non-contac... Read more
Headache; Left arm pain near injection site; Fatigue; This is a spontaneous report from a non-contactable consumer. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on her left arm on 28Dec2020 at 12:45 at a single dose for COVID-19 immunization. Medical history included hypertension, migraine, polycystic ovaries (PCOS) and allergies to wasp venom and dust mites. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 28Dec2020 at 15:45, the patient experienced mild left arm pain near injection site that lasted a few hours, severe fatigue which started 3 hours post injection and lasted for 4 hours; and moderate headache which started on 29Dec2020 (duration 3 days). The patient did not receive treatment for the adverse events. The patient recovered from the events. No follow-up attempts are possible. No further information is expected.
46 2021-01-13 pain in extremity On January 4th i was sitting down eating my lunch and when I was done and went to get up I couldn't ... Read more
On January 4th i was sitting down eating my lunch and when I was done and went to get up I couldn't put weight on my left foot. Felt like i sprained it. The pain was there for two and a half days and suddenly it went away and i was ok. Now this past sunday January 10th my period came, 15 days earlier, and is really bad. I have to change pads like every two hours because of the amount of blood coming down and is still going on today. It has never lasted this long and I have not bleed this much for this long either.
46 2021-01-13 tingling Achy joints and bones, low grade fever 99.9, chills, feeling of needles pricking my skin- Tuesday ar... Read more
Achy joints and bones, low grade fever 99.9, chills, feeling of needles pricking my skin- Tuesday around 1130am- went home from work and took ibuprofen. stayed home from work Wednesday- started to taper off pre immunization medication of benedryl, Pepcid, and prednisone on Wednesday afternoon. Wednesday night noticed using my inhaler. Little more- I took Half dose of prednisone. Had to do nebulizer treatment later that night. Thursday morning woke up wheezing took another prednisone and used rescue inhaler. Went to work and wheezing didn?t get any better, but didn?t get any worse. Took another prednisone and sent home to do nebulizer. Continued to rest and monitor asthma- Notified PCP of what was going on- advised to continue Pepcid, benedryl and prednisone for a few more days and advise of any issues.
46 2021-01-13 tingling paresthesia of the left arm and hand; heaviness of the left arm.; This is a spontaneous report from ... Read more
paresthesia of the left arm and hand; heaviness of the left arm.; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 46-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231, expiry date 30Apr2021) via an unspecified route of administration in the left arm on 08Jan2021 at 15:30 for COVID-19 immunization. Medical history included migraine (she occasionally had migraines and treated it with ibuprofen). The patient's concomitant medication included ibuprofen for migraine (the last dose of Ibuprofen was two or three days ago before 08Jan2021). The patient had received the first single dose of BNT162B2 on 18Dec2020 for COVID-19 immunization and experienced soreness in the left arm which lasted for a day and a half. No other vaccine received within 4 weeks. The patient experienced paresthesia of the left arm and hand on 08Jan2021. She received the first dose of the vaccine on 18Dec2020 in her left arm and had some soreness in the left arm at that time, which was resolved on 20Dec2020 (event reported in AER 2021019477). On 08Jan2021, she received the second dose also in her left arm and within five minutes she had this strange paresthesia of the left arm and hand. She also described it as strange heaviness of the left arm. No limited range of motion of the left arm. She didn't know if it was serious. She didn't visit emergency room or physician office. After two hours (the time of reporting) she still had the same sensation. The event was not resolved. The reporter considered the event paresthesia of the left arm and hand was related to the vaccine.
46 2021-01-14 weakness Temature, body aches, headache, weak and vomiting
46 2021-01-14 weakness Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird meta... Read more
Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird metal taste; very thirsty at times; throat seemed swollen; Still feeling tired and weak; Still feeling tired and weak; running nose and draining in the back of my throat; running nose and draining in the back of my throat; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received first dose of BNT162B2 (Lot# EK9231), via an unspecified route of administration, in left arm, on 07Jan2021 14:30 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Medical history included migraines, depression and allergy: latex. The patient's concomitant medications were not reported. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient experienced flu symptoms, fever, chills, achy body, dry mouth with weird metal taste, very thirsty at times, throat seemed swollen, all symptoms started Thursday, the evening of getting the vaccine and lasting until Saturday morning. Still feeling tired and weak. Now have running nose and draining in the back of my throat. The start date of all the events was 07Jan2021. No treatment was received for the events. The outcome of the events was not recovered.
46 2021-01-14 weakness Body ache , feeling weak
46 2021-01-14 difficulty speaking, flushing severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; i... Read more
severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; it took a minute for her to catch her breath; flushed; itchy; muscle aches; something that look like hives on the arm/hives on the lower right arm; skin felt really hot to touch; fire engine red on the right upper arm; pain at the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 06Jan2021 11:00 in deltoid left at single dose for covid-19 immunization. There were no medical history and concomitant medications. Family medical history relevant to event was none. Relevant tests were none. Patient reported she received the Pfizer COVID-19 vaccine on 06Jan2021 and had pain at the injection site. On 07Jan21 she started having muscle aches and got something that look like hives on the arm and her skin felt really hot to touch, it was fire engine red on the right upper arm. On 08Jan2021, she woke up and felt like she got hit by a tractor trailer, has severe aches, voice very raspy, and very wiped out with headaches. Patient mentioned injection site arm was bright red and warm to touch after injection, but has improved. When waking up this morning on 08Jan2021 even walking this morning from the bedroom to the bathroom she was fatigued and it has gotten better with her walking around, but she still felt wiped out. The muscle aches was very short lived. She went to do something at work and it took a minute for her to catch her breath and that and the muscle aches went away and that was it. An hour later she felt very flushed and itchy and coworkers joked with her about what she ate for lunch, which was nothing different. On the opposite arm from injection arm she had hives on the lower right arm. They were there about 15-20 minutes and it turned completely fire engine red and that lasted about half an hour. She showed the doctor she worked with and they recommended diphenhydramine hydrochloride (BENADRYL), which she didn't take, it was weird. All this subsided and she felt fine afterwards. Last night she felt very fatigued when walking around the house. This morning when she woke up she felt very, very, very fatigued. Walking took a lot of effort out of her. It is hard to explain, but people say this was how they felt when they had Covid. She felt very lethargic and very tired. Patient still had a lingering headache, but nothing like she felt earlier this morning. It's not terrible, but it wasn't pleasant for a couple of hours. Patient was unable to provide seriousness for today's events (08Jan2021), and stated it wasn't really life threatening, but more significant than yesterday. Patient denied having any other vaccines the same day or 4 weeks prior. No history of problems or adverse events with vaccines in past. Pfizer Covid-19 vaccine with events were reported as related. Events did not require a visit to emergency room or physician office. Outcome of severe aches, voice very raspy, headache/lingering headache, wiped out /fatigued/tired were not recovered; outcome of lethargic, it took a minute for her to catch her breath, flushed and itchy was unknown, and outcome of other events were recovering.
46 2021-01-14 feeling hot, tremor, flushing I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by ... Read more
I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by a truck. Later that evening my temp went to 102F, after that I was sleeping 10 hours a day, no appetite, nausea, vomiting, diarrhea, 9lbs in 9 days, back was killing me, alternated hot and cold compress. One morning I woke up and my tongue was like a rock, I was so dehydrated. Fever for 5 days, took Tylenol and it would just break it down to 100F. Went to COVID and flu on the 12/29 got positive for COVID on 12/31/20. Yesterday I felt hot and flushed and was sweating profusely, other than that no other symptoms. ( I received the second dose on 01/13/21)
46 2021-01-14 feeling of body temperature change, pain in extremity arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold ... Read more
arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold at times; within minutes she felt like she had a knot on her throat; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899) in the hospital via intramuscular route on 23Dec2020 at 13:45 at a single dose on the right arm for COVID-19 immunization. Medical history included seasonal allergy, allergy to latex and an allergic reaction to something she ate and by the time they did the allergy test, they could not find what it was. The patient carried an EpiPen for years. The patient's concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient was not administered any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient got the shot and within minutes she felt like she had a knot on her throat, the nurse assisted and gave her water. They kept her for 30 minutes on observation. She was fine after that and next day, her arm was sore, she had a pounding headache, ear ache and checked her temp and it was 99.8 (unit not specified) and she felt hot and then cold at times all on 24Dec2020 at 13:00. She took Motrin 600mg and it helped out. The outcome of the events was recovered. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19.
46 2021-01-14 numbness, weakness Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and ... Read more
Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Tighten in chest; Weakness; dizziness; Slept for over 24 hours; Nausea; vomiting; This is a spontaneous report from a contactable other Health Professional (HCP) (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on 07Jan2021 14:30 at single dose in her left arm for covid-19 immunization. Medical history included dermatitis contact and asthma. The patient had allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) at single dose in her left arm on 17Dec2020 14:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced feft arm went total numb for over 72 hours, red and swollen all the way up to the shoulder, tighten in chest, weakness and dizziness, slept for over 24 hours, nausea and vomiting on 08Jan2021 04:30. The events result in doctor or other healthcare professional office/clinic visit. The patient received prednisone 100 mg to treat these events. The outcome of the events was recovered in Jan2021.
46 2021-01-14 pain in extremity sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a s... Read more
sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the left arm on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 (reported as three weeks ago from 07Jan2021) for COVID-19 immunization and she was fine. The patient got the second COVID vaccine on 07Jan2021 afternoon. The pain at the injection site to left arm started on 07Jan2021 20:00. On 07Jan2021, in the middle of the night, the fever, headache, and legs hurting started. She has been sleeping all day on 08Jan2021 and she does not do this normally. Outcome of the sleeping all day was unknown, of the headache was recovering, of the pain at the injection site to left arm was recovered on 07Jan2021, of the legs hurting and fever was recovered on 08Jan2021.
46 2021-01-14 tingling A few minutes after receiving the vaccine patient developed tingling in all four extremities and st... Read more
A few minutes after receiving the vaccine patient developed tingling in all four extremities and stated that her lips felt weird
46 2021-01-14 tingling A few minutes after receiving the vaccine patient developed tingling in her extremities and stated t... Read more
A few minutes after receiving the vaccine patient developed tingling in her extremities and stated that her lips felt funny.
46 2021-01-15 feeling cold, tremor 12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. ... Read more
12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. 2:30 -5 Skin on face feels like it is burning from the inside out & fatigue. Brainfog. 2:30 thru evening Face and neck puffy, red, hives & fatigue.
46 2021-01-15 flushing Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and f... Read more
Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and facial flushing , mild facial swelling, and feeling of heart racing. Initial vital signs: blood pressure 117/58 mmHg, pulse 91 beats per minute, and oxygen saturation 97% on room air. Patient administered oral diphenhydramine 50 mg once and observed for a total of one hour from vaccine administration during which symptoms improved. Vital signs were checked every five minutes and remained within normal ranges during entire observation period. Patient given water and juice and left in stable condition.
46 2021-01-15 numbness, tremor Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swo... Read more
Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swollen, developed minor tightness in throat and feeling tongue swollen along with tremors and lightheadedness. BP 140/102, HR low 100s. Took Benadryl 50mg with bottle of water. Symptoms resolved over next 30 minutes. Developed numbness in left 4th and 5th digit which resolved at approximately 1 hour. About 1 1/2 hours after injection some abdominal cramping and 1 episode of diarrhea. BP and HR back to normal at about 1 hour after event.
46 2021-01-15 muscle spasms Unexpected menstrual period - I am currently on Lo Loestren Fe for birth control. I have not had a p... Read more
Unexpected menstrual period - I am currently on Lo Loestren Fe for birth control. I have not had a period in 15 months since I started using this pill. 11 days after receiving the vaccine, I had cramps and a heavy period which lasted 7 days.
46 2021-01-15 pain in extremity Previously reported when first started: report # 219108 on 1-3-21 Additional symptoms that occurred ... Read more
Previously reported when first started: report # 219108 on 1-3-21 Additional symptoms that occurred since then: extremely itchy blotchy rash that attacked underarms, under bra area, stomach, lower back, legs. Skin was hot to the touch, felt like a mild sunburn, sensitive to the touch, difficulty wearing clothes. Pain in muscles/joints in hands, and knees .
46 2021-01-16 numbness, tingling This is a report about me. I received my Covid vaccine on Sunday after my hospital shift (if was fir... Read more
This is a report about me. I received my Covid vaccine on Sunday after my hospital shift (if was first dose of the Pfizer vaccine). Other than some muscle soreness, which I expected, I started experiencing numbness and tingling in the arm that received the shot (my left arm). It is now 4 days later, and the numbness/tingling is not any better. I don't know if this is a frequent side effect that will go away in time, but it is very concerning to me.
46 2021-01-16 numbness Rapid onset facial & neck numbness, headache
46 2021-01-16 numbness Besides soreness on the injection site on both times, a day after received the second dose of Covid-... Read more
Besides soreness on the injection site on both times, a day after received the second dose of Covid-19 vaccine I have experienced left-arm site soreness, aches all over my body i.e back pain and muscle pain, malaise, chills, and numbness on the fingers on my left arm.
46 2021-01-16 pain in extremity 24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The h... Read more
24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The highest I recorded was 104 at resting. My normal is 74. I felt tired but wired and started recording it on my smart watch. After 48 hours it returned to more of a normal rate but still continues to be more elevated than before. I will follow up with my PCP this week. I had other symptoms that seemed normal-headache, chills, exhausted, sore arm, etc.
46 2021-01-16 tremor Began with chills - shaking in bed for 2 hours, 11 hours after getting vaccine. Woke in middle of n... Read more
Began with chills - shaking in bed for 2 hours, 11 hours after getting vaccine. Woke in middle of night with 103 fever which lasted 36 hours. SEVERE headache began on Day 2 which I wondered if I should go to urgent care. Unable to tolerate walking or being "up" for more than 3-5 minutes at a time. Notable fatigue. A week later now, still having daily headaches which are moderate in nature.
46 2021-01-17 numbness, tingling 1. Runny nose/sore throat and extreme fatigue started about 4pm. 2. By 8pm I had extreme body chills... Read more
1. Runny nose/sore throat and extreme fatigue started about 4pm. 2. By 8pm I had extreme body chills/dizziness with a temperature of 101. That is when the muscle weakness went into overdrive. I was unable to sleep more than an hour overnight due to the chills and muscle pain. Early in the morning of 1/12 I messaged my supervisor and called the main pharmacy that I was unable to be there for my 9-5:30pm and would be out for the day. 3. Around noon on 1/12 the temperature went below 100 degrees and around 4pm on 1/12 I was finally able to eat something and start moving around. 4. On Saturday 1/16 I started having right arm weakness and my fingers tingling/numbness that hasn?t resolved. This is the arm that I received both injections in.
46 2021-01-17 pain in extremity arm really hurt; stomach cramping; didn't feel well; This is a spontaneous report from a non-contact... Read more
arm really hurt; stomach cramping; didn't feel well; This is a spontaneous report from a non-contactable Nurse anesthetist reporting for herself via Pfizer employee (friend). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 08:00 at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) received via an unspecified route of administration on 18Dec2020 at 08:00 at single dose. The patient was taking COVID-19 vaccine since is front line healthcare worker. The patient was vaccinated at hospital. Age at vaccination was 46 years. The patient's medical history and concomitant medications were not reported. The patient reported she had no problems with the first dose but after the second dose that night (08Jan2021) her arm really hurted and she had stomach cramping. She didn't feel well at all. The patient took two Advil and the next day (09Jan2021) she was fine and is still fine. The Pfizer employee stated her friend looked fine as she was exercising. Onset date of the events was also reported as 09Jan2021 with recovery date 10Jan2021. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
46 2021-01-17 pain in extremity Pt developed left arm pain, shooting pain down the left arm and up in the the shoulder/ neck. Severe... Read more
Pt developed left arm pain, shooting pain down the left arm and up in the the shoulder/ neck. Severe pain and did to to urgent care for pain management on 1/16/21. 1/17/21, did develop a rash and is consistent with shingles.
46 2021-01-17 tingling, weakness I noticed that my arm started itching, tingling and my whole arm and hand became weak. I started bur... Read more
I noticed that my arm started itching, tingling and my whole arm and hand became weak. I started burning under my armpits. Then, I started having issues swallowing. I felt a general feeling of weakness all over. I went to the ER because I was scared I was having a stroke.
46 2021-01-17 tingling Vaccination at at 12 noon - on 16/01/2021 - at 4 pm tingling of the face - at midnight felt severe h... Read more
Vaccination at at 12 noon - on 16/01/2021 - at 4 pm tingling of the face - at midnight felt severe headache, no breathing difficulty, no rash, no swelling of tongue or throat, was able to walk, now feeling much better- after 2 days.
46 2021-01-18 weakness I received the 2nd dose of Covid vaccine at 12:40 pm on Tuesday 1/12/2021, around 6:30 pm I started ... Read more
I received the 2nd dose of Covid vaccine at 12:40 pm on Tuesday 1/12/2021, around 6:30 pm I started with cough and the need to keep clearing my throat. By 9 pm, I felt like my lymph nodes in my neck were swollen, my throat was getting sore, and my head was starting to throb. I took 2 tylenol and went to bed. I woke up at 3 am with a 101.6 temp and body aches. By 8 am on 1/13/2021, I could not lift my own body out of bed or roll over. The fever and body aches continued around the clock for 55 hrs. The headaches are debilitating and continue. I have tried Tylenol, Ibuprofen, Excedrin, and Imitrex and none of these have helped. I missed 3 days of work and 2 weekend days trying to recover and i am still not back to normal. Headaches are still happening everyday. At one point in the middle of this, i felt like I should go to the hospital, but I was too sick to get out of bed and shower and make myself go.
46 2021-01-18 weakness On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/20... Read more
On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/2021 I felt horrible, my stomach was hurting, my left arm was swollen, felt really weak & tired, I had a lot of fatigue & I felt very nauseas. It last 24 hrs.
46 2021-01-18 flushing 1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sen... Read more
1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sensation of tightness in chest and throat but no dyspnea, able to talk, no change in MS. Evaluated by PA - Code Green called. VS stable, transferred to ICU> In ICU labs completed, monitoring continued - all stable. Ate sandwich without difficulty or N/V. discharged to home 1/13: Had continued sensation of numbness and tingling in tongue that night and metallic taste in mouth with fatigue and headache. Aprox 11am 1/13 developed racing heart , increased numbness and tingling in tongue and metallic taste in mouth. Called 911 - transferred to different hospital. Evaluation including EKG completed without finding. Symptoms gradually resolved - discharged how with instruction to f/u with PCP. 1/14 - Home/stable, mild change in sensation in mouth and tongue persist otherwise tolerating all activity, working from home without difficulty.
46 2021-01-18 numbness, pain in extremity Pain and numbness on L forearm near the injection site Mild hypertension and tachycardia
46 2021-01-18 numbness Facial numbness to left side of face (same side as injection). Stated reaction stronger and faster t... Read more
Facial numbness to left side of face (same side as injection). Stated reaction stronger and faster than previous reaction with first dose. EE sent to the ED for evaluation.
46 2021-01-18 migraine, pain in extremity Chills, Fever 100.5, Arm and Leg muscle pain, fatigue, Migraine, Nausea
46 2021-01-18 tingling HEADACHE DIZZINESS TINGLING IN LOWER EXTREMITIES
46 2021-01-18 unresponsive to stimuli Patient received vaccine around 1pm and during the 15 minute observation period she became nonrespon... Read more
Patient received vaccine around 1pm and during the 15 minute observation period she became nonresponsive. She did not fall, but slumped in her chair and would not answer questions. Glazed look. Removal of mask showed swollen lips and neck and an epi-pen was administered at 1:14 and 911 called immediately. During the next 5 minutes the patient began to answer questions. EMTs arrived 1:25 and by then the patient was speaking, and did not want to go to the emergency room. EMTs loaded her onto the stretcher and transported her at 1:35.
46 2021-01-19 difficulty speaking, muscle spasms I began itching at the nape of my neck then all over my trunk and arms. I became hoarse, had visibl... Read more
I began itching at the nape of my neck then all over my trunk and arms. I became hoarse, had visible muscle spasms, and my teeth began to chatter uncontrollably.
46 2021-01-19 feeling of body temperature change, pain in extremity, tingling Hello, When I received my second Covid vaccine, I was asked to report my side effects to this emai... Read more
Hello, When I received my second Covid vaccine, I was asked to report my side effects to this email address. They are as follows: After Vaccine 1 (12/22/20): I had the vaccine at around 1:30pm. I only had arm-stiffness at first. Approx. 24 hours after however (1:30pm the next day), I started having chills and feeling like I had a fever. My entire body ached but I did not have a headache. These side effects lasted through the night for approx. 14 hours. The following day I woke up with a surge of energy and felt very much like I had been given a shot of adrenalin. I?m not sure that I have ever felt as good. After Vaccine 2 (01/11/21): I had much more severe side effects after the second vaccine. I had this vaccine at approx. 1:30 pm and within a couple of hours I started to feel a bit tired. At approx. midnight that night, I started having body aches and a headache that woke me up. I had chills and was oscillating between feeling very cold and feeling very hot. Through the night I had to change my clothing several times due to sweating. These symptoms lasted for the entire following day. The second day after the vaccine I felt much better but still a little tired. Of greatest concern is that I have a lingering pain deep within my left arm (the arm into which the shots were given). Having a hard time extending my arm and doesn;t seems to be going away. Sometimes it feels tingly and I sometimes have loss of grip and/or weakness in the entire arm. Hope this helps you in compiling the side effects. Thank you.
46 2021-01-19 flushing A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. ... Read more
A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. Right ear was flushed red. No symtoms in left ear. No tongue swelling. Symptoms eventually resolved after approximately 1 hour.
46 2021-01-19 flushing About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of ch... Read more
About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of chest, and continuous cough. Was administered one dose of epi-pen injection, steroid injection, and oral benedryl by doctor on site. 20 minutes later flushing, headache, and extreme nausea. Was given second dose of epi-pen and sent to the hospital in an ambulance for monitoring.
46 2021-01-19 pain in extremity the day following the vaccine this patient had lots of arm pain, swelling of the neck, and a swollen... Read more
the day following the vaccine this patient had lots of arm pain, swelling of the neck, and a swollen lymph node near her collar bone
46 2021-01-19 tingling suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; ... Read more
suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; Continue paresthesia and proprioreceptive deficits of left arm; This is a spontaneous report from a contactable nurse (patient). This 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730) intramuscular, in right arm, on 16Dec2020 at 14:00, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included hypothyroidism, migraine headaches, IBS and COVID-19 (on an unspecified date prior to vaccination). Past drug history included allergy to morphine. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 09:30 the patient experienced suddenly lost mobility of left arm, continue paresthesia and proprioreceptive deficits of left arm. She was transported to the ER and was admitted to hospital for 2 days. CT of brain X3, MRI of brain X2, MRI of C-spine and Brachioplexus were performed with unknown results. The patient was not tested for COVID19 after vaccination. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. No treatment was administered. The events had not yet resolved.; Sender's Comments: Based on the temporal relationship, the association between the events " lost mobility of left arm, continue paresthesia and proprioceptive deficits of left arm" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-01-19 tingling Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 min... Read more
Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 minutes after. Taken to ER approximately 25-30 after injection for evaluation. Symptoms not escalating, eventually treated with Benadryl, steroids and Pepcid, held briefly for observation, released with Claritin and steroid prescription to take for the next few days. I was instructed to premedicate for the 2nd dose. Approximately 5-6 hours after dose developed tightness in chest, tingling face/lips/mouth/fingers. Symptoms persist still, self medicating with Benadryl and klonapin.
46 2021-01-20 weakness Fever; In morning my temperature was 100.4; Headache; Felt tired from weak; Felt tired from weak; Fe... Read more
Fever; In morning my temperature was 100.4; Headache; Felt tired from weak; Felt tired from weak; Feels bad; Chills/shivering; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3248), via an unspecified route of administration in the left arm on 09Jan2021 as single dose for COVID-19 immunization. Medical history included covid-19 in Oct2020. The patient's concomitant medications were not reported. The patient experienced fever; in morning my temperature was 100.4 on 10Jan2021 with outcome of unknown; headache on 10Jan2021 with outcome of unknown; felt tired from weak in Jan2021 with outcome of unknown; chills/shivering in Jan2021 with outcome of recovered in Jan2021, feels bad in Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included fever at 100.4 in Jan2021. Details were as follows: patient received the first dose of the Covid-19 vaccination and woke up with a fever and a bad headache in the morning. As it related to casualty, the reporting nurse indicated yes and commented that she was fine the day prior and then when she woke up this morning, she had fever and a bad headache. She indicated that she felt like a little; she got it in the morning around the 11 O'clock. And then by the evening she felt tired. She thought that she was just tired from the week. And when she woke up on this morning, or in middle of the nigh, she was shivering a little bit. She fell asleep and woke up the next morning, with a temperature of 100.4. She said that she did not feel really that bad; she had a headache; she did not have shivering or chills then. Therapeutic measures were taken as a result of fever; in morning my temperature was 100.4, headache, felt tired from weak, shivering, feels bad, chills and felt tired from weak ; she took ibuprofen. The chills/shivering recovered in Jan2021; the outcome of the other events was not reported
46 2021-01-20 numbness, tingling numbness and mild pins and needles in my right thumb, index and middle finger, Right side of mouth a... Read more
numbness and mild pins and needles in my right thumb, index and middle finger, Right side of mouth and right cheek, and Headache. all except fro headache Resolved by 0630. Numbness lower lip and chin started at 0831 1/21/21, headache persists. No muscular deviation.
46 2021-01-21 breast pain, pain in extremity 8 1/2 hrs. after receiving 2nd dose, right arm became very painful, right axillary lymph nodes enlar... Read more
8 1/2 hrs. after receiving 2nd dose, right arm became very painful, right axillary lymph nodes enlarged, and right breast pain and swelling started. Symptoms impeded function of arm. Seen by a provider on 1/19/2021
46 2021-01-21 burning sensation, feeling hot Shortly after the vaccination I got a burning warming sensation up and down my left leg which still ... Read more
Shortly after the vaccination I got a burning warming sensation up and down my left leg which still presist today. I had a fever for one day but had diarrhea for about a week.
46 2021-01-21 burning sensation, numbness Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered set... Read more
Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; This is a spontaneous report from a contactable Other HCP. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscularly on 28Dec2020 10:30 at single dose for covid-19 immunisation. Vaccine location: Left arm, dose number: 1, facility type vaccine: hospital. Medical history included viral asthma, hypertension, mild depression, anaphylaxis to Bee Stings, vertebral artery dissection with brainstem injury and covid-19 (If covid prior vaccination: Yes). Concomitant medication included acetylsalicylic acid (ASPRIN), metoprolol (METOPROLOL), omeprazole (PROTONIX [OMEPRAZOLE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity and fentanyl and experienced drug hypersensitivity. On 11Jan2021 02:00 the patient developed "full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting up". The patient was taken to emergency room (ER) /department or urgent care. In the ER all labs and CT with and without contrast clear, but was unable to find any other reason for the event. No treatment received. The events outcome is recovering. The action taken was not applicable.
46 2021-01-21 cold sweat, hot flush Feeling dizzy like I just got off a cruise ship with nausea and hot flashes on and off no fever but ... Read more
Feeling dizzy like I just got off a cruise ship with nausea and hot flashes on and off no fever but felt intermittently clammy/sweaty started on the 20th and resolved midday on the 21st until the morning of the 22nd, the dizzy/nausea returned and occasional sweaty/clammy feeling. Called OHS and they recommended calling pcp. PCP called in script for zofran and instructed me to take that and dramamine and call if not improved by Monday the 25th
46 2021-01-21 flushing allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well ... Read more
allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well a few minutes after receiving it; her throat felt thick; had trouble swallowing; This is a spontaneous report from a contactable other HCP and pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (lot: EL3247, Expiry Date: May2021), via an unspecified route of administration in left arm on 15Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included food allergic. The patient's concomitant medications were not reported. The patient experienced allergic reaction on 15Jan2021. The patient alerted she wasn't feeling well a few minutes after receiving vaccine. The patient was experiencing being flushed, had a fast heart rate, and her heart rate kept increasing over time, despite two benadryl, the patient had allergic reactions in the past due to food, so the patient knew what it felt like, so could expect it, so the patient spoke up soon, and the Epipen was given 28-30 minutes later, and after that, the patient said her throat felt thick and she had trouble swallowing, so was taken to the hospital. The patient seemed to be getting worse, after time, after the Epipen. The patient was most likely admitted to the hospital. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-01-21 numbness 1320: arrived in 30 minute observation. 1350 notified she had waited 30 minutes and if feeling well ... Read more
1320: arrived in 30 minute observation. 1350 notified she had waited 30 minutes and if feeling well she could leave. Patient stated she had had some left lateral hand numbness since just after the injection that now is feeling more like tightness than numbness, a new tickle in the throat and tongue which felt "puffy" like "taking up some more space than normal. Denied any other symptoms. 1400: VS 135/90, pO2 98-99%, HT regular at 84, stated throat tickle dissipating, tongue puffiness resolving and left had less tight. 1410: Patient asked to go to BR and returned without complaint. 1420: Patient drank small bottle of water without difficulty, "felt normal to swallow." Patient stated her symptoms had resolved and there were no new symptoms. Patient stated she felt normal and comfortable to drive home.
46 2021-01-21 numbness Nausea and vomiting within 45 minutes of vaccine. Left side facial numbness, allergic swelling of f... Read more
Nausea and vomiting within 45 minutes of vaccine. Left side facial numbness, allergic swelling of face within 1 hour of vaccine, lasting 24 hours with Benadryl & Pepcid given as treatment. Numbness of face occurring 1 week post vaccine. Benadryl given as treatment.
46 2021-01-21 pain in extremity I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to... Read more
I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to ward off arm soreness. I had quite a bit of pain at the injection site with this vaccine, more severe than the initial dose. I felt the same mild fatigue and headache as with the first dose, but yesterday (Thursday (01/20/21) afternoon, around 3-4pm), I noticed soreness in my right axillary area, and found lymphadenopathy with palpation. I took additional ibuprofen and tylenol, and the pain has lessened somewhat today (Friday 01/22/21, noon)
46 2021-01-21 pain in extremity My left arm has been constantly sore non stop since I woke up yesterday more than 2 weeks after gett... Read more
My left arm has been constantly sore non stop since I woke up yesterday more than 2 weeks after getting the vaccine. There was initial soreness that I expected but its more than 2 weeks past now and now I do not want to receive my 2nd dose on 1-26
46 2021-01-21 tenderness On 01/19/2021 afternoon client noticed left parotid gland swelling on left side of neck. Left side ... Read more
On 01/19/2021 afternoon client noticed left parotid gland swelling on left side of neck. Left side wit ear and base of neck was tender and painful to touch. Client has been taking tylenol, lemon candy lozenges, hot packs, and herbal tea. These have provided short periods of relief.
46 2021-01-22 flushing patient went back to the procedure center after receiving vaccine after 15 min observation and compl... Read more
patient went back to the procedure center after receiving vaccine after 15 min observation and complained of N, abdominal pain and out of body experience with inability to talk or describe what happened. Palpitations. No CP, SOB, wheezing or visual changes. HR 140's w occ PVCs, SBP 160-170's SpO2 100% with pt appearing flushed and drowsy. O2 NC, NS 1 liter IV, zofran 4mg IVP x1 given. Admitted to procedure center at 1500 and discharged at 2359.
46 2021-01-22 pain in extremity Pain and swelling at injection site (left arm), dry mouth, thirst, joint pain, lower back and right ... Read more
Pain and swelling at injection site (left arm), dry mouth, thirst, joint pain, lower back and right leg shooting pain
46 2021-01-23 weakness Tired/weak. Sore Throat
46 2021-01-23 weakness Feeling sick , body aches , weakness and visible blood in urine , headaches
46 2021-01-24 weakness Headache, body aches, fatigue, weakness.
46 2021-01-24 feeling hot, flushing Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25m... Read more
Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25mg orally and chest tightness and heaviness received 2nd dose Benadryl 25mg . EMS /cardiac monitored and was transferred to a Hospital.
46 2021-01-24 feeling jittery Shortly after the vaccination the patient complained of nausea and jitters.
46 2021-01-24 muscle spasms, feeling of body temperature change, tremor fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he... Read more
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
46 2021-01-24 pain in extremity, breast pain Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank... Read more
Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank and left breast. Severe swelling and joint pain at left knee and hives down left leg calf. Significant rash and swelling of both eyelids and allover body soreness.
46 2021-01-24 pain in extremity, facial paralysis Had soreness in the arm for two days. On the 26th, evening, I went to take drink of water and some o... Read more
Had soreness in the arm for two days. On the 26th, evening, I went to take drink of water and some of spilled down my face and I thought I just had a fat lip. 27th, I went to work and went to lunch at noon, I went to eat food and I noticed that my mouth -right side was numb. I thought something might be wrong and someone told me that my right side of my face looked slack. Saw on Dec 28, Dr. - had already scheduled an appt for follow up for diabetes - and I told her about my symptoms and she looked at my face and had me smile and crinkle my face. She sent me to my doctor downstairs (she had the nurse call downstairs and told them I needed to be seen that day). I went downstairs and I saw my doctor and my doctor scheduled an MRI on 28th at 7 PM and also ordered for me to take Prednisone and Valtrex. MRI result came back fine. I responded well to both of these meds - I started to get muscle control back into my face. It shot my sugar numbers up but solved the other problem in about 15 days I could shut my eyes without delay and I feel like I have muscle control in my face. January 22, I got the second dose and so far I don't notice anything different.
46 2021-01-24 tremor I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes we... Read more
I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes were hurting and burning really bad.
46 2021-01-25 weakness, cold sweat, night sweats, pain in extremity Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at i... Read more
Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at injection site, radiated: up and across L shoulder blade area, up neck and into head, down to L fingertips 0600 -all above continued, R knee joint pain (sharp/stabbing) 1400 -all above continued except R knee joint pain; spinal pain and intercostal pain began 1900 -all above continued; TMJ, jaw, and 'tooth' pain began Monday, 1/11/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Tuesday, 1/12/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Went to dentist (scheduled appointment on Monday) for cleaning and thorough exam...exam was normal Wednesday, 1/13/21 continuation of symptoms from 1/12/21, but pain worse, ear pain Thursday, 1/14/21 0630 had eaten a full can of chicken noodle soup. Was sitting and working on CEs for work, had taken medications for the day, but added in hydrocodone, half of a 7.5/325mg tablet and ibuprofen 200mg. Felt a severe wave of nausea. Laid my head down on my arms on the table. Do not remember getting up, but remember walking through the kitchen in front of the refrigerator, reaching up to feel my pulse, felt two beats which were too far apart and thought to myself, "I'm going to faint". Apparently I was able to walk about 6 feet further, but I don't remember it. I don't know what time I fainted, but I think I must have fallen. I woke up sometime after 7, disoriented and my head hurt, lying on the kitchen floor. My husband came to my side after I called out to him about 5 times. I was drenched in sweat and very weak. When firefighters arrived they said my heart rate was 'all over the place', from 46 to I don't know what (did not hear). Ambulance arrived around 0730. Glucose was normal. Was taken for evaluation. Was given IV NS (I think 1000mls). Labwork was drawn. CXR, CT, and EKG. ER Dr recommended I follow up with my cardiologist, as she noted mitral valve regurgitation and thought a Holter monitor would be advisable. CXR and CT normal. EKG normal sinus rhythm, but showed anteroseptal infarct of unknown age, confirmed by cardiologist who read the EKG. Also seen by my PCP at 1430, he checked my ears, as they had been hurting as well, said they were clear. Advised alternating tylenol and ibuprofen Q4-6H. Friday and Sunday 1/15 and 1/16 night sweat, TMJ pain, nauseated, headache, neckache, fatigue, shoulders sore, eyes sore, inner ear pain Sunday, 1/17 0500 woke up, lying in bed, dizzy, clammy palms, chest pain (mid-clavicular, just below left breast, stabbing), night sweat, TMJ pain, nauseated, headache, neckache, fatigue, L & R flank pain, BP 115/70, HR 54 Monday 1/18, Tuesday, 1/19, Wednesday 1/20, Thursday 1/21, Friday 1/22, and Saturday 1/23 varying degrees of: fatigue, nausea, dizziness, TMJ, jaw, and 'tooth' pain, palpitations, and ear pain. TMJ and jaw pain worsens with activity.
46 2021-01-25 weakness, tremor Fever; Chills; Aches and Pains; Lethargic; shaking; weakness; Sweats; joint pain; headache; pain in ... Read more
Fever; Chills; Aches and Pains; Lethargic; shaking; weakness; Sweats; joint pain; headache; pain in the armpit of the injection arm; severe sore throat; generally feeling ill; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown), intramuscular in the left arm on 08Jan2021 at 08:30, at a single dose, for COVID-19 immunisation. Medical history included autoimmune disease. The patient has no know allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown), intramuscular in the left arm on 18Dec2020 at 08:00 AM for COVID-19 immunisation. On 08Jan2021, at 15:00, the patient experienced fever, chills, aches and pains, lethargic, shaking, weakness, sweats, joint pain, headache, pain in the armpit of the injection arm, severe sore throat, and generally feeling ill. The patient did not receive treatment for the events. Outcome of the events was recovered. The patient underwent nasal swab on 10Jan2021 with a negative result.
46 2021-01-25 weakness Fever Cough Fatigue Malaise Headache Dizzy Weak Tight chest/short of breath Generalized discomfort J... Read more
Fever Cough Fatigue Malaise Headache Dizzy Weak Tight chest/short of breath Generalized discomfort Joint discomfort
46 2021-01-25 flushing, feeling hot Felt warm and flushed with elevated Blood Pressure
46 2021-01-25 muscle spasms cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a cont... Read more
cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient) and another consumer. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: 30Apr2021), intramuscular (right arm) on 11Jan2021 (around 1:10-1:30pm) at single dose for Covid-19 immunization. The patient received the first dose of COVID Vaccine (BNT162B2, lot number: EK5730, expiration date: 31Mar2021) on 21Dec2020, intramuscular (right arm) for Covid-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021, the patient experienced nausea, some vomiting which has subsided, diarrhea, headache and body aches. The patient also stated that she woke up at 3 a.m. this morning (12Jan2021) vomiting. She vomited for about an hour and half. The vomiting has subsided and now she is just nauseated. The diarrhea initially began about 7:30 a.m. She had 3 bowel movements and she hasn't had a movement since about 8:30. She still has cramping but nothing else. The body aches started within last half hour or so. The headache has been the entire time since 3 a.m., starting when the vomiting occurred. The vomiting was more important at that moment, but she knows her head hurting at the time. The patient verified it was her second COVID vaccine. She received the vaccine yesterday (11Jan2021), between 1:10-1:30p.m. The patient reported that she did have bloodwork, but not in regard to the COVID vaccine. She had bloodwork done Monday, 04Jan2021. The outcome of vomiting was recovering; outcome of event cramping was unknown; while the outcome of other events was not recovered.
46 2021-01-25 pain in extremity Arm soreness, frontal headache
46 2021-01-25 pain in extremity Received 2nd vaccine 1/22/21. The next day I had fatigue, chills, low-grade temp, mild nausea, body ... Read more
Received 2nd vaccine 1/22/21. The next day I had fatigue, chills, low-grade temp, mild nausea, body aches, and arm was more sore than 1st vaccine. Symptoms were pretty much resolved by Sunday afternoon.
46 2021-01-25 tremor, tingling, numbness day of felt "fuzzy" tired chills/rigors and fever 103, body/aches. 1/7 temp 99 still taking APAP q 3... Read more
day of felt "fuzzy" tired chills/rigors and fever 103, body/aches. 1/7 temp 99 still taking APAP q 3 hrs. nausea. rt axilla swollen and severe pain. 18/ bilateral hand numbness and tingling up to elbow. temp normal, nausea better. no axilla or neck swelling. reports tremors (that aren't visible) when tries to write "feels not right". 1/11 all sxs resolved. ok to work.
46 2021-01-25 tremor Employee had first Covid-19 on 01/19/2021. On the night of 01/20/2021, she began to experience uncon... Read more
Employee had first Covid-19 on 01/19/2021. On the night of 01/20/2021, she began to experience uncontrollable shaking and chills. The next day, 01/21/2021, employee developed a total body rash and wen to urgent care where she received intramuscular steroids, oral steroids, and oral anti-pruritic medication.
46 2021-01-26 weakness, pain in extremity Chills, body aches, headache, weak, tired sore arm
46 2021-01-26 weakness Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing i... Read more
Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing in ears began about 1 hour after vaccine given. Fever greater than 102 / chills began about 2 hours after vaccine given. Severe body aches, nausea, and extreme fatigue, extreme weakness, dizziness, and chest pain when taking a deep breath began within 4 hours after vaccine.
46 2021-01-26 tingling, hot flush, numbness the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; ... Read more
the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; I felt a "hot flash" over my face; anxiety; the left side of my face started to tingle and went numb; the left side of my face started to tingle and went numb; Lymph nodes in my neck were swollen and painful; Lymph nodes in my neck were swollen and painful; This is a spontaneous report from a contactable Other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included allergies: Penicillin, irritable bowel syndrome (IBS) and endometriosis. The patient's concomitant medications were not reported. The patient previously took dilaudid and experienced drug allergy. A minute after vaccination on 12Jan2021, the patient felt a "hot flash" over her face, thought it was anxiety and ignored it. 25-30min after vaccination the left side of her face started to tingle and went numb, lasted a few hours and went away. That night the patient's lymph nodes in her neck were swollen and painful. The following day after vaccination on 13Jan2021, the tingling/numbness came back in her face in waves, but moved to her lips and the tip of tongue. Day 3 after vaccination on 14Jan2021, the patient still feel some slight numbness in waves still only on one side of her face and the tip of tongue, but not as intense or frequent. Not sure if this could be an allergic reaction. Injection site was left arm and it was the left side of her face effected. The patient underwent lab tests and procedures which included COVID test Nasal Swab: negative on 14Jan2021. The outcome of events was recovering. Information on Lot/Batch number has been requested.
46 2021-01-26 tingling, night sweats Severe muscle aches and fatigue, chills, night sweats, hypersensitivity of skin (prickly sensation0
46 2021-01-26 tremor Took second dose COVID vaccine on 1/18/21, had fever, fatigue, headache that lasted through the day ... Read more
Took second dose COVID vaccine on 1/18/21, had fever, fatigue, headache that lasted through the day of 1/19, only took 1g dose of Tylenol that evening mostly due to headache. I woke up feeling fine on 1/20 but then developed some shakiness that evening. On 1/21, I had fatigue/tiredness, and other than food/bathroom, stayed in bed resting. On 1/22 continued to feel fatigued and dizzy, finally checked my BP, the readings were 93/67 (did not write down HR - heart rate) and 89/68, HR87. I videoconferenced the Methodist urgent line, spoke to NP, recommended continued check BP and increase fluid intake. Still feeling slightly dizzy and tired, but better overall, just feel slightly "off", especially with exertion. BP: 1/23 - 98/76 HR84 , 104/83, HR77; 1/24 - 102/82, HR87; 1/25 - 109/75, HR68, 104/67, HR58, 98/79,HR104, 96/74, HR93; 1/26 - 94/69, HR81, 95/72, HR74, 98/64, HR80; 1/27 - 121/84, HR81 (during MD video visit), 114/80, HR75, 96/74, HR82. Spoke to my doctor today. She asked if I'd filled out this form so decided to fill out. She recommended I continue to monitor BP, increase fluid intake, restart vitamins, add electrolyte drink, add caffeinated drink (for intermittent headache) and follow-up next week if not resolved.
46 2021-01-27 weakness High Fever bones hurt sores under tongue and inside throat Weak
46 2021-01-27 pain in extremity Headache, Myalgia, C/O body aches and fatigue, and sore arm Narrative: Employee endorsed symptoms ... Read more
Headache, Myalgia, C/O body aches and fatigue, and sore arm Narrative: Employee endorsed symptoms started 1/12/21 between hours of 2-5A.
46 2021-01-27 tingling 25th Jan-body aches, fatigue, HA, nausea 26th Jan 2021-Body aches, fatigue, HA, N/V, Chills, severe ... Read more
25th Jan-body aches, fatigue, HA, nausea 26th Jan 2021-Body aches, fatigue, HA, N/V, Chills, severe low back pain, bilateral arm tingling 27th Jan 2021-Body aches, HA, fatigue 28th Jan 2021-Fatigue
46 2021-01-28 discomfort The pressure like midsternal pain started on 1/28/2021 around 10:00, I was standing. It came on and ... Read more
The pressure like midsternal pain started on 1/28/2021 around 10:00, I was standing. It came on and went away throughout the day. I woke up on 1/29/2021 and about 11:00 I started having the same pain again. I am more tired today. I have problems with acid reflux in the past usually after eating too much or during my menstrual cycle. I have been seen in hospital recently prior to covid vaccine and my heart is very great. I don't smoke or drink alcohol, no illicit drugs. I took Prevacid, it didn't help. The pain comes and goes with no aggravating or relieving factor.
46 2021-01-28 feeling hot, tingling pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff ... Read more
pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3. It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown. No follow-up attempts are possible, No further information expected.
46 2021-01-28 muscle twitching facial twitching within 24 hours after receiving vaccine, sent to neurology
46 2021-01-29 flushing Patient reported experiencing itchiness in her throat 6 mins after receivng the vaccine. No redness ... Read more
Patient reported experiencing itchiness in her throat 6 mins after receivng the vaccine. No redness or swelling at the injection site. Pt verbalized that she experienced this same reaction 4 yrs ago after recieving the Flu vaccine. Pt administered Benadryl 50mg IM to the L Deltoid area at 1710HR. Pt resting and being monitered. Pt is now reporting dizziness at 1730HR, face is flush, B/P 188/88, HR- 122. Pt reported that she has POTTS. Pt consumed sips of water and is continuing to rest. Pt moved to the sitting position @ 1755HR and HR is 98. At 1600HR pt is able to get up and walk without difficulty and reported feeling better. Pt encouraged to report to the hospital if symptoms worsen and to report incident to her PCP. Pt assisted out by her husband.
46 2021-01-29 tingling, pain in extremity 4 hours after the administration of her COVID-19 vaccine, she developed the onset of twitching of he... Read more
4 hours after the administration of her COVID-19 vaccine, she developed the onset of twitching of her left eyelid, some left-sided jaw pain, a cotton mouth sensation, and migratory left-sided facial paresthesias described as a tingling sensation that could involve the eyelid, nostril, scalp, cheek, or forehead. These sensory symptoms feels somewhat like a Christmas tree with lights going on and off in different spots but always restricted to the left side of her face. In addition she experience a mild headache but without associated scotoma, nausea, vomiting, or vertigo. Upon looking in the mirror she thought that perhaps there is some slight facial asymmetry on the left side. In addition she reports feeling that her neck is weak on the left side and that she has to support her head in order to keep it from flopping further to the left. The symptoms have been also associated with some pain in the left arm which has since improved as well as discomfort and achy sensation involving her left leg extending from the hip laterally down to the level of the knee. She was evaluated the next day by a neurologist. Her neurological examination demonstrates some subjective decrease in sensation involving the left V1 and V2 distribution but is otherwise normal. Difficult to know to what extent the prior Botox injections could be contributing to her worsening left-sided neck weakness. We are aware that the vaccine does induce a inflammatory cytokine response and it is conceivable that this is contributing to some of her symptoms. MRI was obtained to exclude any underlying CNS pathology that could be conceivably exacerbated in the setting of an inflammatory micro environment induced by the vaccine. There was no clear evidence of a new CNS lesion based upon the examination.
46 2021-01-29 tenderness Patient claims axillary and supraclavicular pain, after 48h of 2nd dose vaccination with Pfizer vac... Read more
Patient claims axillary and supraclavicular pain, after 48h of 2nd dose vaccination with Pfizer vaccine. That has recovered in 75% since onset of symptoms. Pt claims tenderness in the right neck area, with a non visible but palpable lump the size of a quarter. Patient took a dose of tylenol 1g which subdued most of the symptoms, and reports today 1/30/2021 only local tenderness, with no other side effects to report. Pt also claims feeling of chills, and flu like symptoms 24 hours after the vaccination which subdued with a dose of Tylenol 1g.
46 2021-01-30 numbness, tingling Headache / Nausea / Vomiting / Fever / Numb tingly feeling on face
46 2021-01-30 numbness Pt states she felt woozy and had numbness radiating across shoulder blades
46 2021-01-31 weakness Patient called to report that after receiving her vaccine on Friday: during the middle of the night ... Read more
Patient called to report that after receiving her vaccine on Friday: during the middle of the night she starting feeling chills and had a temp of 101. She took some ibuprofen and her fever broke around 9030 or 1000 on Saturday because she became very diaphoretic. She reports that she slept approx 19 hours on Sat and she had chills and sweats off on during this time period. She just felt weak and tired. On Sunday she felt better, just tired. Today, Monday 2/1 she did not come to work due to being tired and feels dehydrated due to the fever and being weak and sweating spells she had. She also states that her Right arm pit is swollen
46 2021-01-31 weakness malaise; weakness; nausea; This is a spontaneous report from a contactable healthcare professional (... Read more
malaise; weakness; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Dec2020 08:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant at time of vaccination. Concomitant medication included linaclotide (LINZESS), omeprazole, ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient previously took erythromycin and DEMEROL and experienced allergy. The day after first injection, patient had extreme malaise, weekness and nausea on 20Dec2020 06:00. Outcome of the event was recovered. No treatment was received for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
46 2021-01-31 burning sensation This is a spontaneous report from a contactable healthcare professional (patient). A 46-year- old fe... Read more
This is a spontaneous report from a contactable healthcare professional (patient). A 46-year- old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 16 Jan 2021 at 12:45 PM at a single dose for COVID-19 immunization in a hospital. Medical history included high cholesterol, GERD, Barrets esophagus, IBS-C, brain aneurysms, and known allergies to penicillin. The patient also received first dose of other vaccine in left (arm). Concomitant medications included clopidogrel bisulfate (PLAVIX), pravastatin, amitriptyline, famotidine, and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient has known allergies to Topamax. The patient experienced burning feeling from chest down to feet, tachycardia, high blood pressure, and chest pain on 16 Jan 2021 at 12:45 PM. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. No treatment received for the events. The patient is recovering from the events. Information on the batch/lot number has been requested.
46 2021-01-31 pain in extremity, burning sensation severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; blee... Read more
severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; bleeding gums; small hematomas on legs; extremely hot diarrheas; horrible burning sensation; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EJ1686, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 14:15 at a single dose for COVID-19 immunization administered at the hospital. She received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EK5730, expiration date was unknown) via an unspecified route of administration on the left arm on 18Dec2020. Relevant medical history included known allergies to shellfish. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. On 09Jan2021 at 12:00 AM, the patient experienced severe headache, severe neck pain, severe arm pain, fever at 103 degrees Fahrenheit (F), swollen lymph node, bleeding gums, small hematomas on legs, and extremely hot diarrheas that she had this horrible burning sensation. The patient did not receive any treatment for the adverse events (AE). The patient underwent further lab tests and procedures, which included COVID test via nasal swab post vaccination on 13Jan2021, which resulted negative. The patient was recovering from all the events.
46 2021-02-01 muscle spasms About two hours after the receiving the vaccine, I started getting a headache. I was rotating betwee... Read more
About two hours after the receiving the vaccine, I started getting a headache. I was rotating between Tylenol and Ibuprofen every 8 hours. The muscle spasms started Friday neck and shoulder. On Sunday I couldn't even turn my head. Today I noticed I broke out in hives arms, legs, back and stomach. Today I had a temperature 102 this morning, I just checked it again and it was down to 100. Today I went to my Doctor. She prescribed you Methylprednisolone dose pack and Cyclobenzaprine hydrochloride for muscle spasms.
46 2021-02-01 pain in extremity I had blood drawn yesterday in left arm annual health exam and the blood draw site hurt yesterday ... Read more
I had blood drawn yesterday in left arm annual health exam and the blood draw site hurt yesterday no big deal but it was more than usual Next day left arm and muscle upper arm aches.
46 2021-02-02 pain in extremity left upper inner thigh rash, left leg pain
46 2021-02-02 pain in extremity fever, body aches, sore arm, arm red and warm to touch
46 2021-02-02 tingling, numbness, muscle spasms felt like a cramp in face on one side of her cheek and it felt like her face was not working right; ... Read more
felt like a cramp in face on one side of her cheek and it felt like her face was not working right; arm and legs were tired; tingling in her forehead and in nose/tingling in arms and in legs and her feet felt the worst; numbness; Muscle weakness; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK9231, unknown expiration), via an unspecified route of administration in left arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient reported that she had some things happened just after receiving the COVID-19 vaccine on Tuesday morning (12Jan2021). The patient later on experienced tingling in her forehead and in nose on 13Jan2021. The next day (14Jan2021), it started like tingling in arms and in legs and her feet felt the worst. On 14Jan2021, two days after (Thursday), she felt like her arm and legs were tired. On Friday (15Jan2021), she woke up and felt like a cramp in face on one side of her cheek and it felt like her face was not working right. Three days later (Friday), she still feels that it is better than it was. The patient also experienced numbness and muscle weakness (both in Jan2021). She don't know what she should do or if she should get the next shot, she almost felt like it was the worst and need to go to the hospital but her body was not so fatigued, she felt her muscle worked hard, described as weak. The patient haven't seen by her doctor or visited in emergency room. The patient did not receive treatment for the events. Outcome of the events was unknown. The events were assessed as non-serious.
46 2021-02-03 weakness Pfizer-BioNTech COVID-19 Vaccine EUA Nausea, chills, HA, muscle aches, weakness and some dizziness. ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Nausea, chills, HA, muscle aches, weakness and some dizziness. The Nausea started around 05:00 Am on 2/3/21 some dry heaving. Other symptoms have been progressively worsening throughout the morning. No Temp.
46 2021-02-03 burning sensation, tingling Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site te... Read more
Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site tenderness, sinus pressure, sore throat, eye pain (R), burning sensation and tingling. Seen at ED on 1/12/21.
46 2021-02-03 difficulty speaking Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report fr... Read more
Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse. A 46-year-old nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose in the Left arm on 15Jan2021 at 11:30 am for COVID-19 immunization.Medical history included allergy to latex. The patient's concomitant medications were not reported. On 15Jan2021 at 12:00 am the patient experienced lip and mouth numbness, hoarseness, chest pressure and lightheadedness. Since the vaccination, the patient has not been tested for COVID. No treatment was received. The outcome of the events was unknown. Information on the lot/batch number has been requested.
46 2021-02-03 feeling jittery Metallic taste, eyes watering, feeling jittery, eyes itching, needs to take deep breathe
46 2021-02-03 flushing On day 1 post immunization @ 14 hours, I started to feel nauseated then developed chills, flushing ... Read more
On day 1 post immunization @ 14 hours, I started to feel nauseated then developed chills, flushing of face, body aches. On about 24 hours post immunization, I developed temp. 100.9 , chills and with wet cough , headache. Post 24 hours, fevers, sweats, wet cough and continued headache. On day 3 post immunization, no more fevers, wet cough, and chills with sweats, head ache , body ache and pain at sight subsided. As of date of reporting experiencing, sweats, chills and wet cough. Starting taking Tylenol and Ibuprofen for symptom management.
46 2021-02-03 feeling of insects crawling on skin, tingling, numbness numbness from her hand, wrist, and fingers up to her elbows in her left arm, she described it as "a ... Read more
numbness from her hand, wrist, and fingers up to her elbows in her left arm, she described it as "a neuropathy type of feeling"; tingling fingertips/gets bouts of tingling or being numb/neuropathy type, numb tingling sensation; like a traveling sensation; her joints, later clarified that she has to keep opening and closing her left hand; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 15Jan2021 10:00 at SINGLE DOSE, for covid-19 immunization. The patient is right-handed which is why she got the vaccine in her left arm. Medical history included ongoing high blood pressure since an unknown date in 2011 (diagnosed about 10 years ago). There were no concomitant medications used. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient was experiencing numbness from her hand, wrist, and fingers up to her elbows in her left arm, she described it as "a neuropathy type of feeling"; tingling at her fingertips, her joints, later clarified that she has to keep opening and closing her left hand. All of these has been continuous, and it seems like it was getting worse not better. It was uncomfortable and hard to explain, it was weird. She describes that it was like "a pain that travels from her elbow to wrist but its numb at the same time". Her left hand gets bouts of tingling or being numb. She has to open and close her hand. Her left arm feels essentially numb from her wrist to the elbow region. She knew there was something going on the day of the injection like a traveling sensation, but she started to really notice the neuropathy type, numb tingling sensation on Saturday (16Jan2021). She clarified that she was not in pain. She did not have any of these symptoms prior to getting the vaccine She was hoping it will go away because it was concerning since it has been about a week since the vaccination. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
46 2021-02-03 migraine WOKE UP WITH TERRIBLE MIGRAINE THAT MADE ME NAUSEOUS AND BODY ACHES WITH EXTREME FATIGUE. MIGRAINE ... Read more
WOKE UP WITH TERRIBLE MIGRAINE THAT MADE ME NAUSEOUS AND BODY ACHES WITH EXTREME FATIGUE. MIGRAINE LASTED CLOSE TO 10 HOURS. BODY ACHES AND FATIGUE LASTED 2 DAYS.
46 2021-02-03 muscle spasms Mild to moderate pain behind left ear; spasms in left ocular area; This is a spontaneous report from... Read more
Mild to moderate pain behind left ear; spasms in left ocular area; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247), via an unspecified route of administration in the right arm on 19Jan2021, at 11:15 as single dose for covid-19 immunization. Medical history included Raynaud's from an unknown date, but otherwise healthy. No allergies to medications, food, or other products were noted. Concomitant medication included acetaminophen (MANUFACTURER UNKNOWN), ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN), both on unspecified dates within 2 weeks of vaccination. The patient previously received BNT162B2 on 29Dec2020 for covid-19 immunization in the left arm, when the patient was 46 years old. The patient experienced mild to moderate pain behind left ear on 19Jan2021, at 18:00 with outcome of recovering; spasms in left ocular area on 19Jan2021, at 18:00 with outcome of recovering. The events were non-serious and described as mild to moderate pain behind left ear and spasms in left ocular area beginning approximately 6-8 hours post injection. Continuing, but lessening frequency and intensity. No therapeutic measures were taken as results of the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The outcome of mild to moderate pain behind left ear was recovering.
46 2021-02-03 pain in extremity Sore arm for two days, headache and body aches for 7 days
46 2021-02-03 pain in extremity really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm... Read more
really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm in her armpit/Incredibly sore arm; Fever and chills; Red at injection site; Very tired; Bad headache; This is a spontaneous report from a contactable other health professional reported for herself. A 46-year-old female patient received the first dose of BNT162 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer, lot number: EL9262,) via unspecified route of administration at age of 46 years old on 21Jan2021 10:15 AM at single dose and vaccine location at left arm, for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included: prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications reported as there had other medications the patient received within 2 weeks of vaccination. The patient past drugs included: allergies to prochlorperazine (COMPAZINE) and amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported really swollen and sore underneath her arm in her armpit. Patient presented fever and chills. Red at injection site. Incredibly sore arm. Patient was very tired and bad headache, the adverse events reported started on 21Jan2021. It was reported the non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. There was no treatment received for the adverse event. Outcome of events were not recovered.
46 2021-02-03 tingling -Palpitations -Rash -Tingling of Hands and Feet
46 2021-02-03 tingling I have been having body aches but they have all but disappeared but the tingling through out... Read more
I have been having body aches but they have all but disappeared but the tingling through out body still continues
46 2021-02-04 pain in extremity symptoms began 02/02/21 that night and lasted about 24 hours. headache, muscle aches, nausea, fever... Read more
symptoms began 02/02/21 that night and lasted about 24 hours. headache, muscle aches, nausea, fever, chills, right arm soreness
46 2021-02-04 pain in extremity I got shot at 7 am Thursday morning. I had sore arm around 130 pm. And was all day. At 130 am Frid... Read more
I got shot at 7 am Thursday morning. I had sore arm around 130 pm. And was all day. At 130 am Friday morning. I woke with chills. I took my temp. It was 100.8. And he lot as high as 101.2. Between 130-430. I woke up again at 630 and it was 100.3. I have been warm all day now. I do not feel I need attention o am sweating it out.
46 2021-02-04 pain in extremity sore arm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female p... Read more
sore arm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3247) on left arm on 21Jan2021 10:00 AM at a single dose for COVID-19 immunization. Medical history included Penicillin allergy. Patient was not pregnant. Concomitant medications were not reported. No other vaccine administered in four weeks. No other medications administered in two weeks. Patient experienced sore arm on 21Jan2021 10:30 AM with outcome not recovered. No treatment was received. No COVID prior vaccination. No COVID tested post vaccination.
46 2021-02-04 pain in extremity Chills began about 1/2 hour later. The chills got continuously worst as the day went on.; Immediatel... Read more
Chills began about 1/2 hour later. The chills got continuously worst as the day went on.; Immediately after the shot I felt nauseated; lethargic; ache and pain in my arm is tremendous; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 vaccine; unknown lot number and expiration date), intramuscular left arm on 21Jan2021 11:30 at a single dose for covid-19 immunization. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The patient received the most recent COVID-19 vaccine in nursing home/senior living facility. The patient reported that she has never had an adverse effect to this degree from any injections or vaccinations. She mentioned that immediately after the shot (21Jan2021 11:30 AM), she felt nauseated then chills began about 1/2 hour later. The chills got continuously worst as the day went on. It has only been about 4 hours since the shot and she was very lethargic and the ache and pain in her arm was tremendous. She was an extremely active athlete and she has not been sick in over 2 years. The patient did not receive treatment for the adverse events. The events were considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event chill was not recovered while the outcome of the other events was unknown. The following information on the batch/lot number has been requested.
46 2021-02-04 tremor, tingling, muscle spasms Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we att... Read more
Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO. I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.
46 2021-02-05 bell's palsy Started with Bell's Palsy on 02/04/2021
46 2021-02-05 tingling, pain in extremity pain and tingling in left arm and hand within 1 week of first dose, tingling/paresthesias in both ha... Read more
pain and tingling in left arm and hand within 1 week of first dose, tingling/paresthesias in both hands and feet/lower legs 1 week after 2nd dose, daily, worse at night when trying to sleep
46 2021-02-07 feeling hot Feeling warm, dizzy, light-headed, hypotensive
46 2021-02-07 pain in extremity Symptoms began 2/2/21 that night and lasted about 24 hours, HA, muscle aches, nausea, fever, chills ... Read more
Symptoms began 2/2/21 that night and lasted about 24 hours, HA, muscle aches, nausea, fever, chills & right arm soreness
46 2021-02-07 tingling pt verbalized tingling in hands and swelling in hands post vaccination.
46 2021-02-07 tingling Within three months, left arm which is the injection site, was struggling to lift up much at all, le... Read more
Within three months, left arm which is the injection site, was struggling to lift up much at all, left hand went tingly, once Nurse came saw that I had an increased pulse. When medics came through as increased pulse and increased blood pressure. Was cleared after about 15 minutes. The next day was decently sleepy with a decent headache. Then was fine.
46 2021-02-07 tremor Upper body shakiness, rapid heart rate Started within a minute of shot. Rash over face, neck and ch... Read more
Upper body shakiness, rapid heart rate Started within a minute of shot. Rash over face, neck and chest within 10 minutes of shot. Feeling of nausea after 25 minutes Selling of tongue with a fuzzy feeling 35 minutes after test.
46 2021-02-08 inability to speak One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and w... Read more
One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and was short of breath unable to talk by the time I reached ER (anaphylaxis). Also rash to chest and arms.
46 2021-02-08 flushing 7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to th... Read more
7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to the ER and had high bp 153/101 and tachy arrhythmia, such as trigeminy and bigeminy and heart rated in the 130?s. My ear also swelled and got hot and red on the same side as the shot. I was monitored for about three hours and then released after bp went down to 130?s/ 90?s and palps decreased.
46 2021-02-08 muscle spasms, numbness, flushing 0930- she complained of sever neck pain and asked for Ibuprofen, 0945- nausea, blurred vision, leg s... Read more
0930- she complained of sever neck pain and asked for Ibuprofen, 0945- nausea, blurred vision, leg spasms, she took 12.5mg of Benadryl, 1030- BP slightly elevated, dizziness, numbness in face and arms, flushing- took 25 mg Benadryl per house MD. had her lye down and within 2 hrs most of symptoms resolved. at 1530 continued to c/o facial numbness. sent home with co-worker so she didn't need to drive.
46 2021-02-08 tingling See page 1. (Box 9).
46 2021-02-09 feeling of body temperature change I experienced headaches, chills, muscle aches, felt feverish, felt hot and cold but mainly severe he... Read more
I experienced headaches, chills, muscle aches, felt feverish, felt hot and cold but mainly severe headache. I was also having nausea. I saw PCP on 01-06-2021 and he gave me Phenergan 6.25-10mL, 5mL syrup with codeine to help with my headache. I only took the Phenergan one time in the evening before I went to bed. I also got tested for a rapid Covid-19 test which was negative.
46 2021-02-09 numbness Ten minutes after receiving the vaccine, patient reported to MD in Observation area that she was exp... Read more
Ten minutes after receiving the vaccine, patient reported to MD in Observation area that she was experiencing a headache, tongue and right arm numbness. After MD assessed patient (and patient relayed this was the same reaction she had with the first vaccine), MD kept her in the observation area for 30 minutes as the symptoms subsided. Patient was released when all symptoms were gone.
46 2021-02-09 night sweats Chills and night sweats started 2 days later; Chills and night sweats started 2 days later; Pain ove... Read more
Chills and night sweats started 2 days later; Chills and night sweats started 2 days later; Pain over left eye; Nausea; No appetite; This is a spontaneous report from a contactable consumer reported for herself. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, brand=Pfizer, lot number=EL3247) via unspecified route of administration at age of 46 years old on 21Jan2021 05:00 PM at single dose at left arm, for COVID-19 immunization. The patient medical history included patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Other concomitant medications the patient received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT 25mg), atorvastatin statin. It was reported patient experienced chills and night sweats started 2 days later. Pain over left eye, nausea, no appetite, can sleep at night. All the adverse events started on 23Jan2021 04:00 PM. It was reported case type non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Since the vaccination, the patient had been tested for COVID-19 on 27Jan2021: Nasal Swab (PCR): Negative. There was no treatment received for the adverse event. Outcome of events at the time of last observation was recovering.
46 2021-02-09 pain in extremity headache, tired, body aches, sore arm
46 2021-02-10 weakness Describe adverse reaction: vasovagal syncope several hours after vaccine. Sent to ED via ambulance. ... Read more
Describe adverse reaction: vasovagal syncope several hours after vaccine. Sent to ED via ambulance. Vasovagal symptoms: dizziness; vertigo; lightheadedness; near syncope and weakness. Sent to ED via ambulance from work. ED gave IV fluids and mescaline. Studies performed: EKG; CBC; and BMP. From ED MD note DC instructions: You came to our ER with concerns of dizziness after getting your covid vaccine. We evaluated you with labs, and provided you with meclizine and fluis. The results of our evaluation were reassuring, and we believe that the causes of your symptoms are not immediately life threatening and safe to follow up with your clinic doctors. We've prescribed you meclizine, take it as needed for dizziness. Administration error: no Clinic called No; Transferred to Emergency Department from workplace several hours after vaccine was administered.
46 2021-02-10 weakness - THINK JUST STRONG IMMUNE RESPONSE: - Headache, dizzy, nauseated, weak, Pelvic pain - Enlarged lymp... Read more
- THINK JUST STRONG IMMUNE RESPONSE: - Headache, dizzy, nauseated, weak, Pelvic pain - Enlarged lymph node on Ipsilalent side of shot - Concentration off BLOOD SUGARS SLIGHT Elevation (129-132 fasting) Decrease in Blood Pressure to 104/76 (usually 120s to 130s/80s
46 2021-02-10 flushing Had #2 Pfizer 1/13 8am. At 12 noon noticed tingling and swelling/fullness in upper lip which persist... Read more
Had #2 Pfizer 1/13 8am. At 12 noon noticed tingling and swelling/fullness in upper lip which persists. Slight lightheadeness with exertion, "bad HA," slight ST. During call patient looked in mirror and noted fullness in upper lip with new "cold sore" and lightly flushed forehead w/ flat, non-pruritic, red rash. Denies SOB, wheezing, swelling of tongue or throat. Denies dyphagia, eye swelling. Instructed patient to see provider at clinic now (she is in clinic now) and be evaluated.
46 2021-02-10 numbness Tightening of throat; Numbness in left thumb, arm, and jaw; Confused; Rapid heart rate; Nausea; Incr... Read more
Tightening of throat; Numbness in left thumb, arm, and jaw; Confused; Rapid heart rate; Nausea; Increased blood pressure; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 25Jan2021 at 11:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to bees, penicillin, and dairy. The patient's concomitant medications included loratadine (CLARITIN) and paracetamol (TYLENOL). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a school or student health clinic facility. Within 5 minutes of injection on 25Jan2021 (starting at 11:30), rapid heart rate, nausea, and increased blood pressure began, continued, and worsened. After an hour, these got worse and seen by medics. Then the patient was transported to emergency room (ER) by ambulance but could not be seen for 4 hours. About an hour and a half after the injection (13:00), the patient experienced tightening of throat and numbness in left thumb, arm, and jaw. The patient was also very confused at that point as well. After 2 hours in waiting room, the patient felt well enough to be taken home. The symptoms slowly improved on their own. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No treatment was given for the events. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the events in Jan2021.
46 2021-02-11 feeling hot, pain in extremity within 15 minutes hot all over and 30 minutes pain in my back down my leg into my knee and ankle. Ha... Read more
within 15 minutes hot all over and 30 minutes pain in my back down my leg into my knee and ankle. Hard to walk. progressivly got worse to point unable to walk without pain, lay down without pain. only able to sit. Steroids, NSAIDS, ICE, Whirlpool Therapy, message, chiropractor. Neurologist consult unable to walk. 2/1/21 MRI completed Circumferential disc bulge with superimposed left lateral recess and foraminal disc protrusion at L4-5 resulting in moderate to severe left foraminal stenosis and impingement of the exiting left L4 nerve root. There is contact of the traversing bilateral L4 nerve roots with some mass effect on the traversing left L5 nerve root. Correlate for left L4 and/or L5 radiculopathy.   3. Circumferential disc bulge with superimposed right lateral recess and foraminal disc protrusion at L2-L3 with contact the traversing right L3 nerve root, but no nerve root compression. No compression of the exiting right L2 nerve root. Correlate for right L3 radiculopathy It is my impression that patient presents with acute onset of left L4 radiculopathy. Her MRI scan suggests a far lateral/foraminal left L4-L5 disk herniation. She also has some underlying lateral recess stenosis which is fairly mild.   I discussed the above findings with patient and her husband. I reviewed her MRI scan with the help of a spine model. I outlined both conservative and surgical approaches. However, given her findings and the severity of her pain currently, I think one could argue that a left L4-L5 microlumbar diskectomy via far lateral approach would be her most definitive option. I did outline this procedure in detail with the help of a spine model. I outlined the risks which include but are not limited to infection, bleeding complications, nerve root and/or cauda equina injury, cerebrospinal fluid leak, recurrent disk herniation, spinal instability, the possibility that she could require additional spine surgery in the future, and the possibility that her would not be relieved to her satisfaction. We also discussed trying a left L4-L5 foraminal steroid injection but she has had injections in the past and she actually felt like it gave her more pain. At this point she would like to go ahead and schedule the left L4-L5 microlumbar diskectomy via far lateral approach with METRx. This will be scheduled on an elective basis in the near future.
46 2021-02-11 flushing 1st COVID vaccine received 2/12/2021; experienced flushing, dyspnea, and tongue tingling within an h... Read more
1st COVID vaccine received 2/12/2021; experienced flushing, dyspnea, and tongue tingling within an hour after receiving dose. Was seen at care center and symptoms resolved; see care center encounter from 2/12/21.
46 2021-02-11 flushing Flushed, tingling in mouth
46 2021-02-11 night sweats Chills - Fever - Night Sweats for less than 24 hours
46 2021-02-11 pain in extremity The first dose vaccination on Jan 8, 2021 very mild symptoms of arm soreness about 12hrs after injec... Read more
The first dose vaccination on Jan 8, 2021 very mild symptoms of arm soreness about 12hrs after injection. Lasted only a few hrs. Second dose vaccination on Jan 29, 2021 had more symptoms. Arm pain again about 10hrs after, lasted longer, about a day. About 18 hrs after injection was very fatigued and had a headache. This lasted about 24 hrs. Also had episodes of chills and slight fever. All symptoms were better a day later, though have noticed more headaches the following week.
46 2021-02-14 flushing Patient flushed, tachycardia, elevated BP, headache, nausea, vomiting, chest pain
46 2021-02-14 migraine Two days after second shot I was hit and had onslaught of left side of head with sever migraine head... Read more
Two days after second shot I was hit and had onslaught of left side of head with sever migraine headaches, with intermittent pounding and spiking shot of even greater intensity of pain! It is non stop day and night preventing me from sleeping well and working / do my job. I immediately went to see my PCP who gave my tramdal but I could not handle it. Now I am on Prochlorperazine which is helping some with the pain, but migraine is still there. I had an MRI, and blood lab work! No growths seen in my head...but the symptoms I have are consistent with migraine which I never had until the second shot the of vaccine. I need help! Nothing is making this away yet - I need this migraine headache to go away!
46 2021-02-15 facial paralysis, bell's palsy, numbness Bell?s palsy. Numbness in front part of tongue started the afternoon of 2/12/2021. Morning of 2/13... Read more
Bell?s palsy. Numbness in front part of tongue started the afternoon of 2/12/2021. Morning of 2/13/2021 half of face was unresponsive and droopy. Talked to my doctor on call and she recommended I be seen at urgent care immediately for evaluation. Was seen at Urgent Care on 2/13/2021 and it was determined I had Bell?s palsy as a side effect of the COVID-19 vaccine. They still recommended to get my second vaccine as scheduled on 2/17/2021.
46 2021-02-15 feeling hot Anxious, feeling hot, and claustrophobic .
46 2021-02-16 facial paralysis, tingling Developed rash on lower left back within a day of shot. Rash continued to get worse in pain and spre... Read more
Developed rash on lower left back within a day of shot. Rash continued to get worse in pain and spread some, went to doctor?s office 3 days after vaccine for continued severity of rash and waking up that day with a slight droop on right side of mouth and tingling Sensations. Doctor identified rash as shingles and possible bells palsy episode. Mouth droop and tingling went away next day, shingles still present.
46 2021-02-16 migraine migraine headaches daily since day 2 until present day
46 2021-02-16 pain in extremity This happened the first shot also but I thought it was just me being anxious. Immediately following... Read more
This happened the first shot also but I thought it was just me being anxious. Immediately following my roof of my mouth felt big. Then my tongue and lips felt the tiniest bit swollen. I could breath fine. Then my face (especially my left side) was a bit numb. The same thing happened to my friend but we couldn?t find anything online about our symptoms. I ended up telling the nurse at the front and they told me to take Benadryl and call 911 if scared. They made sure I wasn?t going to be home alone. I felt better within a 1/2 hour of taking the meds. My throat feels a little sore right now along with my arm.
46 2021-02-16 tingling Within an hour of receiving 2nd dose of Pfizer Covid Vaccine, presented to emergency department repo... Read more
Within an hour of receiving 2nd dose of Pfizer Covid Vaccine, presented to emergency department reporting paresthesia in lips and in feet.
46 2021-02-17 numbness, tingling tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingl... Read more
tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; raised blood pressure; metallic taste; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number 0041297301), via an unspecified route of administration in left arm on 15Jan2021, at 17:00 as first single dose for covid-19 immunisation. Medical history included obesity, opiate allergy and artichokes allergy from an unknown date. Concomitant medication included unspecified probiotic, levothyroxine (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), ergocalciferol (VIT D), linum usitatissimum seed oil (FLAXSEED OIL NATURE MADE). The patient experienced the following non-serious events: metallic taste on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; raised blood pressure on 15Jan2021, at 17:30 with outcome of recovered in Jan2021. Details were as follows: following vaccination the patient reported a metallic taste in her mouth, then a tingling sensation in her jaw which extended to her nose and it felt numb with difficulty swallowing, and she also had raised blood pressure. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.
46 2021-02-17 numbness After receiving first dose of COVID-19 vaccine patient began experiencing jaw numbness on both sides... Read more
After receiving first dose of COVID-19 vaccine patient began experiencing jaw numbness on both sides and numbness of the arm. Was brought into ED where she denied any slurred speech, headache, chest pain, or shortness of breath. Denied any hives or itchiness, dizziness, or syncope. Blood pressure in the ED was 186/99 30 minutes after shot.
46 2021-02-17 migraine Migraine headache lasting 12 hours, sensitive to light and sound, dizziness, nausea
46 2021-02-17 tingling Tingling down arm. Wait longer.No worse.Stretch arm. Prn PCP or ER
46 2021-02-17 tingling Paresthesias in feet and hands, strongest in the left hand; This is a spontaneous report from a cont... Read more
Paresthesias in feet and hands, strongest in the left hand; This is a spontaneous report from a contactable physician (patient). A non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration in left arm, on 19Dec2020 at 09:30 AM, at a single dose, for COVID-19 immunization. The patient's medical history included tinnitus, intermittent vertigo, and non-anaphylactic allergy to egg. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 26Dec2020, the patient experienced paresthesias in feet and hands, strongest in the left hand. The event was considered non-serious. No treatment was received for the adverse event. The patient was administered with the second dose of BNT162B2 (Lot Number: EJ1283) on 09Jan2021 at 09:30 AM in left arm. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.
46 2021-02-18 weakness Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spo... Read more
Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
46 2021-02-18 discomfort Approximately 5 minutes after the vaccination, felt a heaviness come over whole body, felt anxious. ... Read more
Approximately 5 minutes after the vaccination, felt a heaviness come over whole body, felt anxious. Approximately 50 min after mouth felt fuzzy/tingly, face felt tingling; had a lightening pain go across body.
46 2021-02-18 feeling hot A couple of minutes after receiving the vaccine, my cheeks and ears got really hot and red. The EMT... Read more
A couple of minutes after receiving the vaccine, my cheeks and ears got really hot and red. The EMTs talked to me, asked if I felt okay and if I wanted to them to take my vitals and then they said we could go. I took two benedryl that I had brought with me and that helped after about 20 minutes or so. I took another benedryl at bedtime because my cheeks were still feeling hot but not as badly as when it first happened.
46 2021-02-18 migraine severe migraine headache unchanged despite Iv infusion, steroid therapy and facial nerve block
46 2021-02-19 cold extremities Failed at vaccine table. EMS evaluated. P66 SaO2 98% R18 BP100/72 3:45 P 63 Sawyer 94% (cold finger)... Read more
Failed at vaccine table. EMS evaluated. P66 SaO2 98% R18 BP100/72 3:45 P 63 Sawyer 94% (cold finger) R16-18 BP 90/pulse 4pm P62 BP 118/Pulse SaO2 90% Husband came to take clientele. Drank 2 waters and had recent shoulder surgery
46 2021-02-21 migraine - Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC... Read more
- Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC meds. Sometimes too high for thermometer to read. - Swelling at injection site (and halfway to elbow), soreness. By Monday this was down to about a golf ball, and it resolved in a week. - Fatigue, slept all weekend and was tired but functioning the following week. - Severe joint pain and muscle aches Saturday and Sunday. I took OTC pain relievers. Went to bed. - Blindingly bad migraine Friday night, worse Saturday, and resolving some on Sunday, somewhat responsive to Naratryptin.
46 2021-02-21 speech disorder Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) ... Read more
Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown. Information about Lot/batch no has been requested.
46 2021-02-21 tenderness 40-60 tender red bumps, mostly on torso.
46 2021-02-22 pain in extremity Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 ho... Read more
Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 hours, all limbs covered in hives and throat felt irritated. Took a 5mg Claritin at that point (fearing hives would worsen during night). Awoke with no reaction next day or thereafter. No hives reaction after first dose. After both doses had typical sore arm for 48 hours; fatigue after second dose only.
46 2021-02-22 pain in extremity Pain in arm, upper body aches, back, neck, shoulder, headache sore throat, congestion.
46 2021-02-22 pain in extremity Daily headaches lasted for 7 days. Arm soreness lastes for 3 days. Needed to take daily Tylenol, aff... Read more
Daily headaches lasted for 7 days. Arm soreness lastes for 3 days. Needed to take daily Tylenol, affected work.
46 2021-02-22 tremor Excessive tremors, inability to walk due to shaking uncontrollably. Delayed speech. Severe headaches... Read more
Excessive tremors, inability to walk due to shaking uncontrollably. Delayed speech. Severe headaches, body aches, and muscle pain.
46 2021-02-23 bell's palsy on the 3rd of feb, my left lips went numb, called 911 and by 11 was diagnosed with bells palsey. Du... Read more
on the 3rd of feb, my left lips went numb, called 911 and by 11 was diagnosed with bells palsey. Due to the fact I have no chronic conditions, live a pretty healthy life, I was told by EMS and various ID doctors it was most likely from the vaccine. Today is day 21 and I still have no movement in face
46 2021-02-23 tingling, weakness patient began feeling tingling sensation at injection site left arm. A few minutes later dizziness ... Read more
patient began feeling tingling sensation at injection site left arm. A few minutes later dizziness and (now stating shortness of breath) original evaluation, assessment and patient statements did not reveal shortness of breath. She was speaking softly, SaO2 was 98. Provided gatoraid and offered weather. Husband stated she had previous similar reaction post-anesthesia. at 1515. Patient began to feel weakness over entire body. Refused ambulance at that time. 1520- began having chest pain, tingling in legs and feet. Husband said he would take her to the ER due to BP continuing to be elevated. 1528- Unable to stand requesting an ambulance. a1530- EMS called at 1535 ambulance confirmed. 1540- Ambulance arrived. Turned over care to EMS
46 2021-02-25 numbness Numbness in face--primarily on the left side (under the eyes, on the side of my nose, on my chin and... Read more
Numbness in face--primarily on the left side (under the eyes, on the side of my nose, on my chin and jaw). This lasted for almost three days. Taking Benadryl and Ibuprofen helped.
46 2021-02-25 numbness Numbness in tongue and hands
46 2021-02-25 pain in extremity Very Sore Arm began after shot and continued through morning of 2/26. Day after shot (2/24), fever o... Read more
Very Sore Arm began after shot and continued through morning of 2/26. Day after shot (2/24), fever of 100.3, chills, extreme fatigue, bone pain, headache, neckache. Everything other than sore arm resolved by morning of 2/25.
46 2021-02-28 cold sweat About 5 minutes after the shot, I developed a sudden sharp pounding headache at the top of the head ... Read more
About 5 minutes after the shot, I developed a sudden sharp pounding headache at the top of the head & near the temple. I also got clammy/sweaty in my neck & the back of head. My hair got damp at the scalp. At nurse took my BP & it was 142/88 which is very high for me. I usually average a low BP. This reaction slowly subsided within 30 minutes. I was able to drive home. I felt nothing more on this day other than soreness in the injection site. On 2/23/21 I woke up with stomach cramping & had looser stools than usual. I also had fatigue & lethargy all day, which got stronger towards the evening. This lasted until 2/25/2021.
46 2021-02-28 numbness About 10 min after injection, experience dizziness, lightheadedness, also described numbness to face... Read more
About 10 min after injection, experience dizziness, lightheadedness, also described numbness to face and drawing of hands. stated she could move her hands, developed some tachypnea and mild SOB with hyperventilation.
46 2021-02-28 tenderness arm swelling, tenderness, armpit swelling
46 2021-03-01 muscle twitching The nurse that administered the vaccine at 4:00 pm and states patient went limp and had vasovagal s... Read more
The nurse that administered the vaccine at 4:00 pm and states patient went limp and had vasovagal syncope immediately upon withdrawing needle from muscle and occurred immediately after vaccine administration. The nurse lowered the patient slowly to the groundf and put the pt's feet up. The pt has had prior episodes of vasovagal syncope in the past. Her pulse was noted to be in the 70s. Small eyelid and lip twitching noted. Pt had no injury as a result of the syncopal episode. Patient transported to the Emergency Room for evaluation at 4:09 pm. Blood pressure upon arrival in the EC was 143/74, pulse 57, Resp 14, pulse ox 99%. Patient able to open eyes to command and nod yes or no. Blood Glucose was 74 and ECG was unremarkable. Discharged to home at 1822.
46 2021-03-01 tremor, feeling cold, pain in extremity sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints h... Read more
sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.
46 2021-03-02 involuntary muscle movements Gait issue; involuntary lips movement; dizziness; fatigue; This is a spontaneous report received fro... Read more
Gait issue; involuntary lips movement; dizziness; fatigue; This is a spontaneous report received from a contactable pharmacist (who is also the patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 12Jan2021, at single dose, for COVID-19 immunization, at the hospital. The patient medical history was not reported. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included levothyroxine and gabapentin. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown) received at age 46 years, via an unspecified route of administration on the left arm, on 24Dec2020, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 13Jan2021, the patient experienced gait issue, involuntary lips movement, dizziness and fatigue. No treatment was given for the events. The outcome of the events was not recovered. Information about lot/batch no. has been requested.
46 2021-03-02 facial paralysis, slurring On Sunday I started with a severe headache. When I woke up on Monday morning I couldn't lift my head... Read more
On Sunday I started with a severe headache. When I woke up on Monday morning I couldn't lift my head. The headache was intense. I could not open my left eye. I had facial paralysis on the right side of my face. I had slurring of speech. When I walked I was dizzy. I fell asleep all day long, and woke up each time completely disoriented.
46 2021-03-02 numbness, tingling, migraine migraine; face numb and tingling sensation; face numb and tingling sensation; vomiting; diarrhea; fe... Read more
migraine; face numb and tingling sensation; face numb and tingling sensation; vomiting; diarrhea; fever; body aches and muscle aches; body aches and muscle aches; really sick; She had the horrible headaches; Nausea; Upset stomach; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular in the left arm on 25Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included migraine. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 for COVID-19 immunization and experienced flu like symptoms, body aches, headache, muscle aches and light fever. No additional vaccines administered on the same date of the Pfizer suspect. The patient had questions about the side effects of COVID vaccine. The patient experienced migraine, face numb and tingling sensation, vomiting, diarrhea, fever, body aches and muscle aches, and has been really sick the night after that second vaccine on an unspecified date in Jan2021. It is slowly getting better and now it had been a Monday a week later from the second dose and she still has the body aches, fever that comes and goes, and headaches that have just been ongoing. She wanted to know if anyone reported any of this or prolonged symptoms. She also mentioned horrible headaches, nausea, vomiting, numbness and tingling in face on an unspecified date in Jan2021. She mentioned again the nausea and upset stomach, body and muscle aches and fever she still has a little of on an unspecified date in Jan2021. The biggest thing was the headaches. The body and muscle aches and fever comes and goes. Thought she was over the fever and it started back again yesterday. She was unable to provide seriousness criteria when queried, only stated that it was very frustrating, it's not life threatening, but she is at home versus being at work. The events migraines, fever off and on, body and muscle aches, diarrhea, vomiting, numbness and tingling in face, really sick required a visit to the Physician office. The outcome of the events migraine, Tingling, Numbness in face, Vomiting, Diarrhea, Fever, Generalized aching, Muscle ache and sickness was not recovered while the outcome of the events headache, nausea and upset stomach was unknown.
46 2021-03-02 pain in extremity Major soreness in arm starting 6pm day of vaccine, and continuing through 3/2. Fatigue and nagging ... Read more
Major soreness in arm starting 6pm day of vaccine, and continuing through 3/2. Fatigue and nagging headache 3/2. Resolved by 3/3.
46 2021-03-04 slurring Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth /... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Approximately 30 minutes after administration, patient reported some difficulty breathing and extreme lightedheadness. Breathing was shallow. Also reported swollen tongue, which led to slurred speech. Benadryl was immediately given and patient was monitored for an additional hour. At the end, patient reported she felt better and speech improved, but still lightheaded like she \"just had 2 glasses of wine.\"
46 2021-03-04 feeling hot, cold sweat Clammy hands, warm wave rushed over my body, felt very hot, racing heart, tightness in my chest-last... Read more
Clammy hands, warm wave rushed over my body, felt very hot, racing heart, tightness in my chest-lasted approx 15-20 minutes
46 2021-03-04 feeling hot Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) s... Read more
Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) she began to feel " a tingly sensation in my tongue" and felt warm. She also had localized redness and swelling at the site of injection (Right deltoid). She denied any symptoms of chest pain, SOB, palpitations, difficulty swallowing, drooling, nausea/vomiting, dizziness or light-headed or near syncope. Patient was observed by provider for a course of one hour. We recommended to be taken by EMS to ER for further observation, she refused. Patient drove herself and was not able to take Benadryl. Initial vital signs taken 10:54am 177/114; HR 92; O2 98% RA; RR 18 -sitting position Second vitals 11:35am 134/96; HR 79; O2 100% RA ; RR 16- sitting position Patient was observed for an hour and decided to drive home. Recommend hydration and call 911 if needed.
46 2021-03-06 pain in extremity 3 hours after started feeling tired, went to bed early. Next morning - Sore arm up into shoulder and... Read more
3 hours after started feeling tired, went to bed early. Next morning - Sore arm up into shoulder and neck, lasted a week Whole-body muscle ache, headache, nausea, diarrhea, exhaustion, lasted two days. The shot was given on a Thursday and had to miss work the next day.
46 2021-03-07 breast pain Swollen axillary lymph nodes in left arm pit with left breast pain
46 2021-03-07 involuntary muscle movements Nausea, something in throat, involuntary finger movement, especially in left hand. Benadryl 50 mg IM... Read more
Nausea, something in throat, involuntary finger movement, especially in left hand. Benadryl 50 mg IM given.
46 2021-03-08 feeling hot, tingling ABOUT 10 MIN AFTER VACCINATION, PT FELT WARM WITH SOME SOB AND TINGLING IN HER BODY + RINGING IN HER... Read more
ABOUT 10 MIN AFTER VACCINATION, PT FELT WARM WITH SOME SOB AND TINGLING IN HER BODY + RINGING IN HER EARS. HUSBAND WENT TO GET HELP AND PT FELL OUT OF HER CHAIR WITH LOSS OF CONSIOUSNESS. PT RECOVERED IMMEDIATELY WITHOUT CONFUSION,. VITALS BP: 102/71 HR: 81. PMH STROKE 2008 WITH RESIDUAL L WEAKNESS. MEDS: ASPIRIN, ZYRTEC, FLONATE. NO PREVIOUS VACCINE REACTIONS OR ANAPHYLAXIS. EMS CALLED TO TRANSPORT TO ER. VASOVAGAL LIKELY.
46 2021-03-08 numbness, migraine, tingling 2/26/21- At time of shot, itchy throat, mouth and face. Next day, felt like I had the flu, light hea... Read more
2/26/21- At time of shot, itchy throat, mouth and face. Next day, felt like I had the flu, light headed, tingly hands and face. On 3/6/21, woke up with swelling, hot, red, itchy swelling at injection site. On 3/8/21, patches of rash that would come and go, face, mouth, and throat itchy. Hand and arms tingly and felt like I was going to pass out. Later that day, had my 1st migraine in my life. 3/9/21-Today, hands, arms, face, mouth, and throat itchy. Finger tips went numb and ring finger on left hand showed signs of bruising (I didnt hurt it that I know of). By the time I got to urgent care, finger no longer bruised color. Light headed, felt like going to pass out again.
46 2021-03-08 tingling 20" after injection patient self-reported feeling lightheaded, dizziness, "foggy", generalized ting... Read more
20" after injection patient self-reported feeling lightheaded, dizziness, "foggy", generalized tingling in her hands and feet and felt like her tongue was a bit swollen. Stated she felt "funny". Also stated that she had a similar reaction after her first dose but states this reaction was more severe.
46 2021-03-09 burning sensation Feeling of burning up from the inside out of body. No Fever. Dizzy, light headed,especially when sta... Read more
Feeling of burning up from the inside out of body. No Fever. Dizzy, light headed,especially when standing. Headache. nauseated
46 2021-03-09 feeling cold, tremor 1005: Complaint of dizziness; BP 160/90s, P 115. No SOB or respiratory difficulty. No rash. Patient ... Read more
1005: Complaint of dizziness; BP 160/90s, P 115. No SOB or respiratory difficulty. No rash. Patient anxious. 1030: Red, raised rash noted to begin on forehead, cheeks, and upper chest. Shaking (slightly) noted in hands. Patient states "feeling cold." BP 162/94, P 108, O2 99% RA. Patient A&Ox3 sitting in chair. 1040: Patient complaint of "lips feeling 'tingly'". Quickly progressed to full facial tingling. Denies dyspnea or chest pain. Still states she " feels dizzy." 911 called. BP 142/88, P 95, O2 99% RA. 1045: Turned over to paramedics. Patient A&Ox3. Rash still present but no worse. Denies dyspnea or chest pain. Still shaky, slight diaphoresis. Husband & son with patient. Patients belongings given to husband. Taken by EMS offsite.
46 2021-03-09 numbness pain/swelling under arm on side of vaccine, later felt swollen lymph area in arm pit. occasional num... Read more
pain/swelling under arm on side of vaccine, later felt swollen lymph area in arm pit. occasional numb sensation down left arm into wrist and fingers.
46 2021-03-09 pain in extremity Within 10 minutes I got very dizzy and nausea and vomiting which lasted over 12 hours. Also racing h... Read more
Within 10 minutes I got very dizzy and nausea and vomiting which lasted over 12 hours. Also racing heart rate then episodes of chills and sweating. The next day I had a hard time holding my tooth brush, pain and swelling to both hands and severe pain in left foot. When I get up from sitting position to walking it feels like my bones in my left foot will shatter. The pain is very bad even in bed when I?m not moving.
46 2021-03-09 pain in extremity got vaccine - about a week later - she sent us a message saying "I have been having right calf pain ... Read more
got vaccine - about a week later - she sent us a message saying "I have been having right calf pain for about a week or more. I have more increased SOB and chest pain." was able to get ddimer which was elevated - and was admitted to the hospital for this since her vaccine - she has noticed increased chest tightness, SOB, hairloss, DVT/PE.
46 2021-03-09 tingling, hot flush, numbness The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything... Read more
The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything went back to normal. Monday around 3:00 or 3:30, face was hot and had hives. She went to the ER. Was told she had a mild rash, and gave Benadryl and ordered EpiPen for emergency. Left ER to pick up prescription but tongue began to swell, went back to ER, gave you Cortisone 50 mg and Pepcid Benadryl IV for 7 days. Yesterday, had another face reaction, had hives very mild only in the morning. Today at 8:00a.m., had redness in face. Around 3:00pm, lips and tongue were swollen and has extremely dry mouth. Today, she is on her way to the ER because her tongue has swollen again.
46 2021-03-10 face paralysis, facial paralysis Pt arrived to ED with CVA like symptoms. Positive F.A.S.T. per EMS with left sided weakness and left... Read more
Pt arrived to ED with CVA like symptoms. Positive F.A.S.T. per EMS with left sided weakness and left facial droop.
46 2021-03-10 flushing, tremor flushing of face, shaking of hands. Evaluated by EMS-Cleared
46 2021-03-11 flushing extreme headache, flush face, flu like symptoms and swollen lymph note under right arm
46 2021-03-12 flushing Pt. c/o dizziness and Headache, racing heart and skin flushing while in observation area of vaccina... Read more
Pt. c/o dizziness and Headache, racing heart and skin flushing while in observation area of vaccination site. Pt. taken to triage area and evaluated by MD. Pt. observed for an additional 30 min and then released to home. 1026- 166/117, Spo2 100%, p 72 1030- 144/105, 72 1032- pt states all symptoms have resolved. 1055- pt. released to home.
46 2021-03-13 involuntary muscle movements I felt like my vision was changing and it felt like my pupils were very tiny. I felt a strange press... Read more
I felt like my vision was changing and it felt like my pupils were very tiny. I felt a strange pressure in the top of my head. Not a typical headache but a weird pressure. I started feeling like I was clenching my teeth and my jaw. That night my arms were very jerky. I wasn?t thinking right. And every day since I feel like I?m tense muscles I?m dizzy I?m just not mentally like I used to be.
46 2021-03-13 tremor Shaky, chills. evaluated by EMS. refusal to transport.
46 2021-03-14 burning sensation, tenderness March 10, 9am, received injection in left arm. Minor headache throughout the day. That afternoon (... Read more
March 10, 9am, received injection in left arm. Minor headache throughout the day. That afternoon (~3:00pm) noticed itchy neck and face. (Since I had a rash last year from skincare products I just thought it was same thing). March 11, rash worse. Treated with topical 2.5% hydrocortisone ointment. Back of head started feeling tender. March 12, evening, back of head feeling worse, took Ibuprofen. Rash much better on face/neck. Middle of night (March 12), head extremely painful and noticed swollen lymph nodes on back/right side of head. March 13, 8:00am, went to urgent care clinic. Received Cefdinir 300mg antibiotic for unknown infection causing swollen lymph nodes. Rash almost gone. Back of head extremely tender/painful. March 14, swollen lymph nodes multiplied on back of head and also on right side of neck. Saw neighbor anesthesiologist who thought my rash and swollen lymph nodes were caused by the vaccine. March 15, lymph nodes still swollen, but feels more burning/itching like a rash now with occasional throbbing pain. Spreading more in right side of neck, which is sore/tender. Slight rash on neck.
46 2021-03-14 feeling hot PT. STATED PRIOR TO VACCINE THAT SHE HAS SEVERE ANXIETY AND GETS VERY ANXIOUS WITH INJECTIONS. PT. P... Read more
PT. STATED PRIOR TO VACCINE THAT SHE HAS SEVERE ANXIETY AND GETS VERY ANXIOUS WITH INJECTIONS. PT. PLACED ON STRETCHER PRIOR TO INJECTION. FIVE MINUTES AFTER INJECTION PT. C/O BEING HOT , FEELING "WEIRD" DENIED BREATHING DIFFICULTIES. EVALUATED BY EMTS, BP 180/120, HR 96, RR32 O2 SAT 100% ON RA. BP RETAKEN WITH MANUAL CUFF BY EMT REMAINED HIGH. PT. BP FOLLOWED FREQUENTLY OVER 30 MINUTES REMAINED ELEVATED TRANSPORTED TO ER BY AMBULANCE.
46 2021-03-14 numbness Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips sw... Read more
Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips swelling and numbness. Epi pen given. Patient rash and hives continued. patient shaky and nervous. patient denied difficulty breathing. BP elevated. O2 sats stable. IV placed in right AC , IV Benadryl 50mg given IV push. Paramedics on site. Patient transported to ED.
46 2021-03-15 bell's palsy Bell's palsy; This is a spontaneous report from a contactable healthcare professional. A 46-year-ol... Read more
Bell's palsy; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, administered in left arm on 26Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy on 01Mar2021. The event was reported to have resulted in emergency room/department or urgent care visit. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association, the known safety profile of the COVID-19 vaccine, and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported bell's palsy and the suspect administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
46 2021-03-15 breast pain 25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave ... Read more
25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave me two Benadryl?s and 4 Pepcid Waited for a hour in a half Symptoms subsided. Around 9 pm I had horrible pain under my arm pit and top of my breast. And fast heartbeat I took two Tylenol and the pain subsided but I am also getting pain in my two lymph nodes on the left side all the time
46 2021-03-15 burning sensation Face burning, severe redness to face, face swelling on the left side, twinge in left side of neck, c... Read more
Face burning, severe redness to face, face swelling on the left side, twinge in left side of neck, chills.
46 2021-03-15 pain in extremity Got shot on Thursday woke up Friday 2am with achy arm, by 7am full body aches and mild temp of 99.4 ... Read more
Got shot on Thursday woke up Friday 2am with achy arm, by 7am full body aches and mild temp of 99.4 Friday all day arm ached,small rash developed right of injection site , brainfog, dizziness. Symptoms went away by Saturday Morning just had a achy arm until Sunday. still expierencing Brain fog . Also experienced Brain fog and dizziness with first dose
46 2021-03-16 numbness, coordination abnormal, slow speech Blood pressure 155/107 Lightheaded, tongue tingling, hand/arm numbness Pressure on chest, dizzines... Read more
Blood pressure 155/107 Lightheaded, tongue tingling, hand/arm numbness Pressure on chest, dizziness and confusion, slow words. Uncoordinated hands and legs
46 2021-03-16 pain in extremity, weakness Fever increasing throughout the day. Currently 102.8 degrees. Taking Tylenol. No energy to move, ... Read more
Fever increasing throughout the day. Currently 102.8 degrees. Taking Tylenol. No energy to move, chills, muscle aches, arm pain.
46 2021-03-17 flushing Patient c/o throat feeling tight and difficulty with swallowing. Stated symptoms the same as with sh... Read more
Patient c/o throat feeling tight and difficulty with swallowing. Stated symptoms the same as with shellfish allergy. Face and neck area were flushed. Benadryl 50mg IM given in right arm. Pulse at 80 BPM throughout the event, alert and oriented, normal breathing. Benadryl took effect within 5 minutes with person stating she could feel her throat loosening up, and tongue feeling smaller. Requested no epinephrine unless really needed. Does carry and EpiPen with her. Observed for one hour after event pulse 78 BPM at discharged. Advised to take Benadryl every 4 hours as needed and to come to ED with any return of worsening symptoms. Escorted to car where family member will drive her home.
46 2021-03-17 numbness Throat begin to close, minor reaction. And numbness on left side of body all the way down.
46 2021-03-18 cold sweat nausea; Headache; malaise; Cold sweats; restlessness; unable to sleep; This is a spontaneous report ... Read more
nausea; Headache; malaise; Cold sweats; restlessness; unable to sleep; This is a spontaneous report from a non-contactable female consumer reported for herself (Non pregnant). A 46-year-old female patient received second dose BNT162B2 (Solution for injection, lot number was EL3246) via left arm on 24Feb2021, 10:30 AM, single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose BNT162B2 (lot number:EL3247) left arm on 03Feb2021, 10:30 AM at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. After second dose vaccination patient experienced headache, nausea, malaise, cold sweats, restlessness, unable to sleep on 24Feb2021 at 08:15 PM. The patient taking treatment 600mg ADVIL taken for all events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
46 2021-03-18 muscle spasms Severe headache, muscle cramping, aches and general body pain. Started 12 hours after receiving vac... Read more
Severe headache, muscle cramping, aches and general body pain. Started 12 hours after receiving vaccine and lasted for about 36 hours.
46 2021-03-18 pain in extremity On March 5, I received my first dose of the Covid shot. Later that day, I was fatigued. Six days la... Read more
On March 5, I received my first dose of the Covid shot. Later that day, I was fatigued. Six days later, however, sometime early morning on March 12, (I was in and out of sleep because of it), I had pain swallowing my saliva on my left side (also the side of my vaccine in my arm). It was hard to pinpoint but the pain came from somewhere at the back of my throat and my ear. If I had to guess what time it was, it probably was around 1-2am that the pain began. March 12, I went to see my primary care doctor. He checked my ears & didn't see any concern. He saw a little redness at the back of my throat but couldn't definitively say what I had. He thought it was a virus but didn?t discount a reaction to the vaccine (although he said it was unlikely since reactions usually happen within 3 days). He ran no tests and didn't prescribe anything. March 13, I was feeling worse. I suddenly had a fever (101 was the highest it ever got), swollen lymph nodes, a white tongue. I went to the local ER at 9am who said I might have oral thrush but he didn?t sound convinced because my tongue wasn't as white o thick as thrush would present (he said for example that typically when you have thrush, you could scrap it off and it would bleed). He diagnosed me with Thrush and Lymphadenopathy. He prescribed anti-fungus medication Clotrimazole 10 mg Troche, five times a day. On Sunday, March 14, my throat pain got worse (it was constant pain v.s. pain only swallowing) so I called the on-call doc who told me to get tested for Strep. The next day, on March 15, I could swallow easier so my doctor didn't think it was necessary. My lymph nodes were still swollen, I had a bit of a fever, and it was still a bit hard to swallow but I was recovering. I had some lingering ear pain. By March 15 I was much better. Today, March 19, I still have a sensation on my left ear/throat area after swallowing but I am much better. Please note that while the ER doctor thought it was fungal and my primary care doctor thought it was viral, neither were sure/thought it was the vaccine. ** Also please note, this is the second time I am completing this because the system booted me off after 20 min the first time and it was erased. It takes times to complete. Just a thought for future reference, it might be helpful to allow for more time.**
46 2021-03-18 tingling Shortly after the injection I had tingling in my left hand which I thought was normal. Now two days ... Read more
Shortly after the injection I had tingling in my left hand which I thought was normal. Now two days since the injection and I still have tingling in my left hand and fingers.
46 2021-03-18 tremor, numbness Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting to... Read more
Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting took a nop as the day went on the pain on my R leg got worse; vomiting fainting took a nop as the day went on the pain on my R leg got worse; Symptoms of fatigue; Pain on my R knee; Went to fever 102.2 then; Chills, into the entire night/Shivers and shakes; Headache; Into the morning could not walk on my R leg/Can not walk on either foot; Numbness to my face; Found a cyst on the back of my knee; Shivers and shakes; Damage to my ligaments; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in the left arm on 04Feb2021 at single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history was none, and concomitant medications were not reported. The patient was not sure about allergies. The Patient not received other vaccine in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via intramuscular Left arm on 14Jan2021 04:30 PM at single dose for COVID-19 immunization (at the age of 46-years). The patient stated, "on 12Feb2021 at 03:30 PM, (as reported: one week after the second dose) after the second dose of vaccination. I started having symptoms of fatigue, pain on my R knee, went to fever 102.2 then, chills, into the entire night, headache, into the morning could not walk on my R leg, numbness to my face, vomiting fainting took a nop as the day went on the pain on my R leg got worse. Went to the ER (emergency room) x ray and ultrasound was done, found a cyst on the back of my knee not sure if it was from the shivers and shakes caused damage to my ligaments, 2 hours later my right foot was in a lot of pain, two bumps onto of my L foot lots of pain went back to the ER on Sunday morning (14Feb2021), x ray was done only no broken bones foot was red turned purplish, this started Friday 12th (12Feb2021) and her Monday the 16th Tuesday missed work and still in a lot of pain cannot walk on either foot very far without my boot or crushes." No covid prior vaccination. The patient underwent lab tests and procedures which included post vaccination sars-cov-2 test Nasal Swab: negative on 23Dec2020; body temperature: 102.2 on an unknown date; ultrasound scan and X-ray: cyst on the back of my knee on 12Feb2021, x-ray: no broken bones foot on 14Feb2021. Took the following treatment measures, shot for pain, cortisone shot, naproxen 500. The adverse events resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relation, the association between the event syncope and the vaccination with BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-03-20 difficulty speaking 1st shot , tingling lips and itchy tongue, slight swelling of tongue!Started within 5-10 min of vacc... Read more
1st shot , tingling lips and itchy tongue, slight swelling of tongue!Started within 5-10 min of vaccine!!Lasted 15 -25min!! 2nd shot- itchy tongue, throat swelling, flemy throat, horse voice,tongue swelling!All happened very quickly, went away within 1-2 hrs! Was very sleepy afterwards and had bad headache!!
46 2021-03-20 numbness The shot did not hurt or bleed when administered. As I was walking around the store, I could feel i... Read more
The shot did not hurt or bleed when administered. As I was walking around the store, I could feel it moving down my arm. It felt numb like how you feel after having dental work. The numbness traveled down my arm to the wrist, then back up the underside of my arm. The numbness and tingling went into my shoulder and then split to travel down the left side of my back. The other split went to my neck then chin. At this point I had spoken to 2 pharmacists and 1 covid question center all of whom gave me the same answer that it was nerves and it was just a pain reaction. This was not pain i was feeling, but numbness where you know you are touching your arm but can't feel it. I knew something was not right.. i know my body. I took a benadryl when the numbness hit my neck and chin. Within 20 of taking benadryl all of the numbness had subsided (at about 3:15ish).
46 2021-03-21 weakness 10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?. 1st Pfizer vaccine receiv... Read more
10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?. 1st Pfizer vaccine received @9:55a in Left Deltoid. BP 100/50, HR 76 and regular. Pt reports this BP being ?a little low for her?. Pt ate breakfast and then had a snack before coming to clinic. She has a distant history of ?getting very sick with the flu vaccine?. Within a few hours of the dose 15 years ago or so, she developed a fever of 103 and had flu symptoms of aching everywhere. The next year they gave her a pediatric dose and she had a similar response and has not had another flu shot since then. She has received allergy shots for more than 10 years and takes OTC allergy meds daily. She took her Zyrtec this am. She spoke with her allergist and received the recommendation to get the Covid vaccine. Her next allergy shots are due next week. She reports feeling fine before and during the injection and then the light-headedness started 5-6 minutes after sitting in the obs area. Site director and pharmacist aware of events. 10:22a Pt drinking water and reports ?feeling strange with swallowing and jaw feels tight?. Pharmacist to pt side and decision made to give 12.5mg of liquid Benadryl. Pt states, ?I wonder how much of this is me being anxious?. 8 oz water consumed and tolerated well. Pt reports ?tongue feels thick? with drinking Benadryl 10:24 pt reports legs feel less weak. 10:29 HR 76, BP 110/70. Husband arrived. Pt reports still feeling the same level of dizzy and throat feeling ?less tight?. 10:38 No change is s/s. Consult with pharmacist-advised giving additional 12.5 mg oral Benadryl. 10:41 Benadryl given and tolerated well. ?I don?t feel great?. Finished second 8 oz bottle of water and third given. Pt reports still feeling the same level of dizzy but has some increased thickness in throat. Improves with drinking cold water. 10:46 Pt reports although throat feels better with water, that her airway still ?feels smaller?. When describing her throat and airway, ?it?s not 100% normal, but better?. 10:50 HR 64, BP 104/64. Pt reports ?dizziness unchanged throughout, legs still feel weak, jaw and tongue feel back to normal, but back of throat still feels tight, but cold water helps but when swallowing, it still feels harder to do?. Reviewed case with pharmacist and site director, recommendation to take pt to ER for further obs. Pt agrees to go. 10:59 Pt transferred safely to wheelchair and escorted to ER. ER RN given report after pt checked in with husband beside her. Recommended to pt that she notify her PCP and Allergist of today?s event and recommended they get a recommendation for receiving the second dose.
46 2021-03-21 feeling hot Notes (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: MD at 3/19/2021 9:22 AM Expand AllC... Read more
Notes (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: MD at 3/19/2021 9:22 AM Expand AllCollapse All 3/18/2021 Subjective female who was seen at Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Pt became hot and light headed after receiving her shot. She was brought by WC to the bay. She was given water and an ice pack was laid on the back of her neck. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness Hot and sweaty: CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Musculo negative Previous Reactions: None Objective Vitals Vitals: 03/18/21 1535 03/18/21 1550 BP: 131/67 130/75 Pulse: 84 65 SpO2: 100% 100% Physical Exam Vitals and nursing note reviewed. Constitutional: Appearance: She is well-developed. HENT: Head: Normocephalic and atraumatic. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Eyes: Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Bowel sounds are normal. Palpations: Abdomen is soft. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion and neck supple. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: water and ice pack Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Pt dismissed to go home at 3:57pm with coworker. Electronically Signed 3/18/2021 4:00 PM
46 2021-03-21 tingling Patient felt tingling/ heaviness in both arms 10 minutes after receiving the vaccine. On site EMS wa... Read more
Patient felt tingling/ heaviness in both arms 10 minutes after receiving the vaccine. On site EMS was called vitals BP 135/85 HR 88 100% O2 She was monitered for 20 minutes and released to go home.
46 2021-03-21 tenderness Day after injection: Swollen arm around injection site. Day two after injection: After swelling decr... Read more
Day after injection: Swollen arm around injection site. Day two after injection: After swelling decreased I had swelling under my arm with a knot the size of a golf ball. Very sore and tender to touch.
46 2021-03-22 weakness Headache, Myalgia, Arthralgia, Fever, WEAKNESS, INJECTION SITE PAIN Narrative: Other Relevant Histo... Read more
Headache, Myalgia, Arthralgia, Fever, WEAKNESS, INJECTION SITE PAIN Narrative: Other Relevant History:
46 2021-03-22 pain in extremity Sore arm
46 2021-03-22 pain in extremity Headache, Myalgia, NauseaVomiting, WHOLE ARM OF INJECTION SIDE, INJECTION SITE PAIN Narrative:
46 2021-03-22 pain in extremity For about 5 hours my body ached, my legs, knees, back, neck, shoulders ached and were in pain sittin... Read more
For about 5 hours my body ached, my legs, knees, back, neck, shoulders ached and were in pain sitting, and stiff and in pain when standing. I took 3 x 200 mg Ibuprofen at 5:30. By 10 p.m. My body aches had disappeared but I was extremely fatigued. I am feeling better now.
46 2021-03-22 tingling, bell's palsy Bell's palsy symptoms. Droopy eye (right) and tingling in the ears.
46 2021-03-22 tingling After patient received COVID vaccine and was waiting the required 15 minutes, patient indicated that... Read more
After patient received COVID vaccine and was waiting the required 15 minutes, patient indicated that they felt a tingling sensation on their left arm that travel upwards as well. They felt their heartbeat a bit fast as well. Blood pressure was taken and it was at 148/92. No other event occurred; patient was able to leave a short time after.
46 2021-03-22 speech disorder I had extreme headache and could not focus I got dizzy and fainted and lots consciousness. I ended ... Read more
I had extreme headache and could not focus I got dizzy and fainted and lots consciousness. I ended up lose muscle control and urinated . Afterwards, I could not speak well. I continued to have massive headaches
46 2021-03-22 tenderness, numbness and pain in extremities, flushing Bilateral arms flushed blanching red/pink color, most prominently in the proximal extremity. Bilater... Read more
Bilateral arms flushed blanching red/pink color, most prominently in the proximal extremity. Bilateral dependent peripheral neuropathy in hands and feet. Bilateral ear tenderness.
46 2021-03-23 weakness Dizziness, Headache, Myalgia, Arthralgia, NauseaVomiting, EXTREME TIRED AND WEAKNESS, INJECTION SITE... Read more
Dizziness, Headache, Myalgia, Arthralgia, NauseaVomiting, EXTREME TIRED AND WEAKNESS, INJECTION SITE PAIN Narrative:
46 2021-03-23 burning sensation "Covid Toes" The toes on my left foot became red, swollen, blistered and Extremely itchy on the 5th ... Read more
"Covid Toes" The toes on my left foot became red, swollen, blistered and Extremely itchy on the 5th day following my first covid vaccine which lasted for approximately 6-7 days. This occurred again one week following my second vaccine (2nd shot 1/29), for approximately 5 days. It has occurred three times since then, all on the Friday anniversary of my getting the shot. The symptoms for the last 3 times lasted only 2 days, and the redness has decreased, but they are still extremely itchy and have now become scaly at the site of where the most severe itching took place. They do burn occasionally at the site of the scales.
46 2021-03-23 feeling hot Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight... Read more
Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight. My heart rate felt like it had jumped and my heart was pounding. I started to feel like it was very hot and I was getting somewhat nauseated and feeling like I might pass out. I checked my smart watch and my heart rate had jumped to over 120. The lady who administered the shot got the EMT on site and they took me for observation. They took my blood pressure and it was 157/114 (which is far beyond the norm for me). They took an EKG on site which they said was not alarming in any way. They checked my blood sugar and it was normal. My oxygen level stayed within a normal range. I had some mild feeling of itching/tingling in my mouth and felt like I had a lump in my throat like a marble. My BP and HR came down some after about 15 minutes but was still high. They called an ambulance and had me go to an ER for further observation since the feeling in my mouth and throat was not resolving and my BP was not coming down to a better range after about 30 minutes. By the time I got to the ER and they monitored me, my BP was still 154/70 and my HR was still in the 80s while at rest. They kept me in observation for long enough for the doctor to feel that I was not in any immediate danger so they discharged me with instructions to return to the ER if things got worse.
46 2021-03-23 flushing, tingling, pain in extremity, weakness About 30 minutes after injection, I felt intense pressure on my upper chest and the base of my throa... Read more
About 30 minutes after injection, I felt intense pressure on my upper chest and the base of my throat, and a headache that felt like my head was going to explode. My face felt flushed, tingly and stiff like a mask. When I stepped out of the car, I felt wobbly and weak. I started feeling nauseous, exhausted and just "out of it". I took an ibuprofen and an acetaminophen. The symptoms slowly decreased over the evening and my air was never fully cut off so I didn't go to the Emergency Room. Today (the day after vaccination), the symptoms were much less severe but I felt more lightheadedness, like I'm on a boat, however, that is something that has been an issue for me over the past several months so it might not be vaccine-related. My arm hurts quite a bit today but not debilitatingly so. I also feel alternately chilled and feverish. Although the highest my temperature measured was 98.9 F, my temperature is typically in the 97's so it was definitely elevated.
46 2021-03-23 flushing Symptoms: Nausea + facial flushing. Client assessed and treated by onsite Paramedics. Client cleare... Read more
Symptoms: Nausea + facial flushing. Client assessed and treated by onsite Paramedics. Client cleared for home at 1:34 pm. Per Paramedics all symptoms resolved, no further evaluation needed.
46 2021-03-23 numbness Face partially went numb on left side for about 20 minutes about 10-15 minutes after injection. Numb... Read more
Face partially went numb on left side for about 20 minutes about 10-15 minutes after injection. Numbness then went away.
46 2021-03-23 muscle spasms I was doing my normal morning jog four days after the 1st vac and a few block in I got a sudden, sta... Read more
I was doing my normal morning jog four days after the 1st vac and a few block in I got a sudden, staggering, lighting-bolt-like headache for about 20 seconds. Nausea. Dizzy. then the headache moved to a painful ache that spread across the back of my head. As that happened, deep in my neck where the spine meets the scull there was a hobbling pain/cramp/spasm. I went to the ER.
46 2021-03-23 unresponsive to stimuli This was this person's second dose. She had episode of syncope following the first dose that require... Read more
This was this person's second dose. She had episode of syncope following the first dose that required prolonged monitoring in the EC. Patient was laid down on stretcher prior to vaccine administration. Patient immediately went syncopal following injection and became unresponsive. Breathing remained even and nonlabored with good pulse. Patient remained lying down for about 30 minutes before she sat in a chair for approximately 15 minutes. Attempt to have patient leave but patient became syncopal again in bathroom and needed to be assisted into wheelchair and brought back to observation area where she laid down for another 15 minutes. Patient was alternating back and forth between being alert and unresponsive. Patient was finally able to leave area with mother at 1719. Refused to be transferred to the Emergency Room for evaluation.
46 2021-03-24 burning sensation Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thicknes... Read more
Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thickness, itchy mouth, and rapid heartrate within 10 minutes, redness, burning, swelling, and itchy skin on face within 15 minutes. Epi-pen given within 14 minutes, and transport to hospital, wheezing in bases of lungs noted by ER physician and diphenhydramine, famotidine, and solumedrol given. Swelling of tongue took 1.5 hours to reduce to half. Overnight stay at hospital, due to severity and duration of symptoms.
46 2021-03-24 feeling hot Follow injection of 1st dose Pfizer, she reports within 1-2 minutes both hands started feeling hot a... Read more
Follow injection of 1st dose Pfizer, she reports within 1-2 minutes both hands started feeling hot and began swelling. Within 5-10 minutes she developed a rash on hands, face, neck and chest. She notified the staff, who provided ice packs for the swelling and placed her in front of a fan. She was monitored for 45 minutes, then released with inst to call 911 if she developed airway problems. She began developing a mild headache. She drove home and took Benadryl 50 mg by mouth, and repeated the dose every 8 hours x 2 additional doses. She took Tylenol for headache. The headache and swelling resolved in 12 hours, and the rash resolved in 16-18 hours.
46 2021-03-24 numbness, tingling congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lu... Read more
congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lung; short of breath; left side of my face became numb; tachycardic; Blood Pressure 162/110; chills; burning in my mouth; tingling throughout body; dizziness; fog brain/Memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days; fog brain/Memory loss; muscle pain; bruising not at site (in legs); lymph node swelling on injection arm sight; I finally felt pain at injection site; This is a spontaneous report from a contactable health care professional nurse, the patient. A 46-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899); intramuscular on 20DEC2020 at 22:30 (at the age of 46 years old) as a single dose, for COVID-19 immunization. Medical history included hypothyroid, Allergic to Latex. The patient previously took levonorgestrel and experienced drug hypersensitivity. The patient's concomitant medications were not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 The patient experienced congestion and wheezing in left upper lobe of lung, short of breath, left side of my face became numb, tachycardic, Blood Pressure 162/110, chills, burning in my mouth, tingling throughout body, dizziness, brain/memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days, muscle pain, bruising not at site (in legs), lymph node swelling on injection arm sight and on about the 5th day Dec2020 experienced pain at injection site. The patient underwent lab tests and procedures which included blood pressure: 162/110 on an unspecified date and heart rate tachycardic on an unspecified date. The clinical course is as follows Shortly right at 15 minute mark of being monitored, I became short of breath, left side of my face became numb, then right, became tachycardic, Blood Pressure 162/110, developed chills, burning in my mouth, tingling throughout body, dizziness, developed "fog brain"/Memory loss prevalent for following 48 hours after injection, remained not as severe about a week after, muscle pain, bruising not at site (in legs) developed lymph node swelling on injection arm sight, developed congestion and wheezing in left upper lobe of lung. "felt as if out of body experience" or just not normal for about 12 to 14 days. Patent Refuse to go to ER, where advised to go after RAD team assessed, around the 5th day I finally felt pain at injection site-which that part would be normal, but I did not feel at 1st due to all the major reactions my body dealt with. As a result of the events the patient did visit a physician. Treatment was given for the events (Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, Vaccination site pain) which included Benadryl, Tylenol, IBU, and steroids, Cold and cough meds OTC. The clinical outcome of the events Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, and Vaccination site pain was recovering while blood pressure 162/110 was unknown.
46 2021-03-24 migraine, cold extremities I immediately felt my right arm getting cold. It then started to feel heavy and weighed down. Soon a... Read more
I immediately felt my right arm getting cold. It then started to feel heavy and weighed down. Soon after, I started getting a mild headache toward the front of my head which intensified towards my temple area. My eyes felt strained ( the back of my eyes ). The feeling was similar to a migraine/sinus pressure. I started getting cold and then my extremities were freezing. I got chills and was shivering ( it was cold in the building, but I wasn?t that cold upon entering ). This was all in the first 15 minutes. I was told to stay for 30 minutes in the waiting area because of my allergy to erythromycin, just as a precaution. Around 20 minutes my mouth became very dry. I also had a metallic taste in my mouth. It became hard for me to swallow and I had to think to swallow because it wasn?t happening naturally. At that time I alerted someone and asked if these reactions were normal. I was given a 25mg Benadryl and had people continuously check on me. It took some time before I was able to not feel the choking closed feeling from swallowing. Once I was able to swallow it felt as if I had something lodged in the back of my throat. Similar to the feeling of phlegm. I kept having to clear my throat because that phlegm feeling wouldn?t ?wash down?. I felt light headed, but not dizzy. More of a foggy feeling. Once they felt it was safe for me to leave I came home and rested. The headache lessened, I was still cold, but not chilled. Into the evening I was very tired and foggy in thinking.
46 2021-03-24 pain in extremity, tingling Hands getting brown spots, like potentially blood; Hands felt achy; Hands tingly; This is a spontane... Read more
Hands getting brown spots, like potentially blood; Hands felt achy; Hands tingly; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266), via an unspecified route of administration on 19Feb2021 at 13:00 (at the age of 46-years-old), at single dose for COVID-19 immunisation. Medical history included congestive heart failure (CHF), dilated cardiomyopathy, psoriatic arthritis and airborne allergies. Concomitant medications included carvedilol, sacubitril valsartan sodium hydrate (ENTRESTO), eplerenone and allopurinol. It was reported that on 25Feb2021 patient hands were getting brown spots, looked like potentially blood. Hands felt achy and tingly. Spots went away in a day then came back. They first appeared on day 6 post vaccine and occurred on day 6, 7 then not again until day 16 but it's the worst at time of reporting. Started on 1 finger, at the time of reporting on several and palm. Mostly occurring on left hand, same arm as shot. The patient did not receive treatment for events. The events were not recovered.
46 2021-03-24 pain in extremity It feels like I have covid again. My main symptom is inflammation or pleurisy around the lungs, but ... Read more
It feels like I have covid again. My main symptom is inflammation or pleurisy around the lungs, but the tightness has gone up into my airway as of today. Arm is still very sore from shot 8 days later. Doctor put me on pain meds (hydrocodone and gave me a shot to help with inflammation)
46 2021-03-24 tingling Foot Tingling like vibrating. Felt like a vibrating cell phone under right foot. Lasted for almost 4... Read more
Foot Tingling like vibrating. Felt like a vibrating cell phone under right foot. Lasted for almost 48 hours after shot. Slight throat scratchiness and tight chest and asthma flair up.
46 2021-03-25 tingling Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusi... Read more
Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusion, tingling, swelling lymph nodes, body ache, headache.
46 2021-03-26 migraine High fever, extreme bodyaches, migraine headache and nausea
46 2021-03-26 night sweats Muscle aches, red face, chills, night sweat, headache, fever from 7:00 3/23 to 12:00 pm 3/25. Symp... Read more
Muscle aches, red face, chills, night sweat, headache, fever from 7:00 3/23 to 12:00 pm 3/25. Symptoms stopped as suddenly as they appeared.
46 2021-03-26 tingling Tingling of left hand. Resolved in 20 minutes.
46 2021-03-27 feeling cold, pain in extremity 5.5 hours after the sore arm. Next morning I was cold but about noon chills started till 7pm with ex... Read more
5.5 hours after the sore arm. Next morning I was cold but about noon chills started till 7pm with extreme exhaustion.
46 2021-03-27 hot flush heart racing, palpitations, shortness of breath, hot flashes
46 2021-03-27 tingling Tightness and discomfort on left side of face in jaw area and tingling in left cheek and left side o... Read more
Tightness and discomfort on left side of face in jaw area and tingling in left cheek and left side of lips 30 minutes after injection of vaccine. Went to ER right away for assessment. They did EKG, monitored BP and did a neuro evaluation.
46 2021-03-27 tingling Immediate tingling sensation on left side of face, mainly around the mouth area. As days continue, ... Read more
Immediate tingling sensation on left side of face, mainly around the mouth area. As days continue, still tingling sensation around the mouth, and fatigue. The fatigue never went away.
46 2021-03-28 bell's palsy facial drooping/Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 4... Read more
facial drooping/Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received dose number 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206) via an unspecified route of administration, administered in the left arm, on 11Mar2021 08:15 AM at a single dose for COVID-19 immunisation. Medical history included diabetes, thyroid, and hernia. The patient had no known allergies. Concomitant medication(s) included metformin hydrochloride (METFORMIN ER); levothyroxine; and omeprazole. The patient had no other vaccine in four weeks. On 12Mar2021 at 2AM, the patient woke up and had facial drooping; went to the ER and was admitted for possible stroke. It was further clarified that it was not a stroke but she has Bell's palsy. The adverse event (AE) resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization (duration for 1 day, from 12Mar2021 to 13Mar2021). AE treatment included medicine, methylprednisolone, valacyclovir, eyedrop. The patient had no COVID prior to vaccination. The patient underwent lab tests which included COVID test type post vaccination (nasal swab, rapid test): negative on 12Mar2021 (COVID tested post vaccination). The outcome of the event was not recovered.
46 2021-03-28 feeling cold The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost pass... Read more
The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost passed out; tired; nausea; headache; almost passed out; Hypertension/BP 155/103; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, expiry date not reported) via an unspecified route of administration, administered in left arm on 04Mar2021 at a single dose for COVID-19 immunisation. Medical history included interstitial cystitis and endometriosis, known allergies to milk and sulfa, have had a complete hysterectomy, and patient was getting hormone injections. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior to vaccination. Concomitant medications were unspecified; it was reported that patient had other medications in two weeks. The patient previously took ibuprofen and experienced known allergies; and had first dose of bnt162b2 for covid-19 immunisation on an unknown date. The patient had no other vaccine in four weeks. The second day after injection (06Mar2021), temperature dropped to 93.7, BP 155/103, and patient was very cold. Patient was dizzy, almost passed out (Mar2021). Patient temp ran from 97 to 98 and was able to get temp up to 95 (2021) but it's been there and dropping to 94.9 since 06Mar2021. Patient did have hypertension BP but take meds for it (Mar2021). Patient was also very tired, nausea and headache on and off (Mar2021). But all those have been reported. It's not normal for the patient to be cold because patient have had a complete hysterectomy and was getting hormone injections. Therapeutic measures were taken as a result of the event hypertension. No treatment received for the other events reported. The patient was not tested for covid post vaccination. The outcome of the events was not recovered.
46 2021-03-28 flushing, facial pain flush, throat closing, stingingin lips and face, dizzy
46 2021-03-28 flushing After receiving shot and moved to waiting area, felt flush and heart palpitations. Heart rate reach... Read more
After receiving shot and moved to waiting area, felt flush and heart palpitations. Heart rate reached high of 153 and bp 150/95. After deep breathing came down but cycled up again several times same day. Heart palpitations continued for 6 days.
46 2021-03-28 pain in extremity, hot flush Swollen, painful arm, hard lump at injection site, redness, itching, swollen lymph nodes on neck and... Read more
Swollen, painful arm, hard lump at injection site, redness, itching, swollen lymph nodes on neck and armpit on vaccine side, chills, fever of 101.2 for 48 hours, severely painful joints, fatigue. Hot flashes, feeling of chills improved but persists even 5 days after
46 2021-03-28 pain in extremity tremendous arm pain for 2 days that began approx 3 hours after injection.
46 2021-03-28 pain in extremity Sore arm and throat . Pt received more than 30 mcg of covid 19 mRNA. When admistering 1.8 ml of dilu... Read more
Sore arm and throat . Pt received more than 30 mcg of covid 19 mRNA. When admistering 1.8 ml of diluent to the vaccine the syringe leaked diluent. only 5/6 doses were able to be recovered. The 6th dose was short by .06 ml.
46 2021-03-28 pain in extremity Large red knot growing daily since shot. The red know is hot, itchy, sore, and is not directly on in... Read more
Large red knot growing daily since shot. The red know is hot, itchy, sore, and is not directly on injection site. The knot started slightly above the injection site.
46 2021-03-28 tingling, numbness, burning sensation Burning, tingling, numbness on left arm, shoulder, face. Most symptoms resolved in 36 hours. Resul... Read more
Burning, tingling, numbness on left arm, shoulder, face. Most symptoms resolved in 36 hours. Resulted in sinus disease left maxillary sinus and swollen lymph glands in neck
46 2021-03-28 tingling Right after she got her shot, patient started feeling tingling in the left side of her body, mostly ... Read more
Right after she got her shot, patient started feeling tingling in the left side of her body, mostly the foot. It felt swollen but it was not actually swollen. It lasted the whole afternoon till the evening, then it started getting better. The next day, it was gone.
46 2021-03-29 weakness, pain in extremity At first only my arm was sore. Then the next day I was extremely exhausted - despite getting a good ... Read more
At first only my arm was sore. Then the next day I was extremely exhausted - despite getting a good night sleep. On Saturday, I was severely nauseated, dizzy and complete loss of appetite and energy. I felt very sleepy and vomiting after drinking any liquids: water, broth, and tea. Symptoms disappeared by Sunday - but still a little dizzy through the day. I am fine, just reporting for your records.
46 2021-03-29 numbness, tingling Heart Palpitations tingly + numb fingers - lasted about 15 min. Rescue came + took her vital signs. ... Read more
Heart Palpitations tingly + numb fingers - lasted about 15 min. Rescue came + took her vital signs. She refused to go with them. She left pharmacy feeling Better.
46 2021-03-29 pain in extremity Sore arm, unusual fatigue for 2 days
46 2021-03-29 pain in extremity Sore throat, fatigue, sore arm
46 2021-03-30 cold sweat, weakness felt very faint and weak; chills/shivers; cold sweating; felt very faint and weak; extreme lethargy;... Read more
felt very faint and weak; chills/shivers; cold sweating; felt very faint and weak; extreme lethargy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 17Mar2021 10:45 (Lot Number: EL3247) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medication was reported as none. The patient previously had BNT162B2 first dose lot number: EL3247 on 24Feb2021 10:00 AM, in left arm for COVID-19 immunization. The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Mar2021 20:30, the patient experienced chills, shivers, cold sweating, felt very faint and weak and extreme lethargy. No treatment was given to the patient for the events. The outcome of the events was recovered on unspecified date.
46 2021-03-30 feeling hot She had a sudden hot sensation come over her. She felt like she was going to pass out. She was dizzy... Read more
She had a sudden hot sensation come over her. She felt like she was going to pass out. She was dizzy- heart rate increased to 122, nauseated and developed a very red rash all over her chest and face. She was given 50mg of Benadryl. She waited for an hour at the clinic and did not need to go to the ER. Symptoms subsided.
46 2021-03-30 numbness, facial paralysis, feeling hot, tingling 3/22 When administered shot body felt a little warm 3/24 Burning pain like a yeast infection or bla... Read more
3/22 When administered shot body felt a little warm 3/24 Burning pain like a yeast infection or bladder infection. Treated at urgent care for a yeast infection 3/25 Woke up with a fever and a rash on my back and chest 3/27 Right side of face was droopy 3/28 Right side of face felt numb, more swollen, droopy, and tingly went to the doctor immediately as worried about Bell's Palsy or worse case a stroke
46 2021-03-30 pain in extremity arthritis; I lost my smell and my taste; I lost my smell and my taste; My stomach was very, very bad... Read more
arthritis; I lost my smell and my taste; I lost my smell and my taste; My stomach was very, very bad like diarrhea; pain like in my back, in my upper back like really bad/her lower back, like she was having a baby, it was opening in her lower back; I could not sleep that day; I felt very, very tired/I felt like I was sick; I have nausea all that; I got was like huge pain on my arm; I began to have rash all over like my left arm and my body; felt like I was sick; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) on 03Mar2021 at single dose for COVID-19 immunization. Medical history included atopic dermatitis. Concomitant medication was none. Patient used took the first dose of BNT162B2 (lot number: EL9266) on 11Feb2021 at single dose for COVID-19 immunization. patient got her second vaccine last Wednesday (03Mar2021) she was like she just have secondary effect like for one week not only it's super late and what surprised her the most it that she lost her smell and her taste, so she thought like she got the COVID, that was on the 4th day (06Mar2021) but she did 2 test, she didn't know one want to keep a track, like how they went like the first day (03Mar2021) she got the vaccine the only thing that she got was like huge pain on her arm that she did not have in her first dosage, she thought it was fine and then next day that was Thursday (04Mar2021), no she felt like she was going to die because the pain like in her back, in her upper back like really bad, she could not sleep that day, she felt like her lower back, like she was having a baby, it was opening in her lower back. She felt very, very tired like she have nausea all that, like all day long, she didn't eat anything because the nausea began in like through the night she could not sleep that night. she said one of like the things that one mention it's going to happen so affects that, then the next day that was Friday (05Mar2021) her stomach was very, very bad like diarrhea or whatever but she felt little better felt tired and then Saturday in the morning (06Mar2021), she lost the smell and the taste so that was when she thought that she really have gotten the COVID, because secondary effect it does mention that one lost smell and taste so she went to do a test and she began to have rash all over like her left arm and her body and then she did the test to the one like quickly and the other one took 2 day and both were negative then on Sunday (07Mar2021) the smell and the taste came back but she still felt pretty tired, feel a lot of rash in her left arm and in her shoulder of right part and she felt like she was sick or maybe yesterday she began to feel better but really tired, really like that one are sick, but this happen not only in today it happen like all this week, this today she began to feel better but she was like that was not because of the vaccine because she thought she got the COVID. It was also reported the first effect (event) was 12 hours lately, 03Mar2021. She thought she had arthritis she went to did her see the doctor and also the doctor like said probably 89% sure that patient don't have arthritis but she was going to do also another because she did rheumatoid test or whatever but also she put her on antibodies or whatever test, that day 2 day ago on Wednesday (10Mar2021) and then she will received those 2 test in last 2 weeks but the first one is like blood test you know. Treatment included the lady that vaccinated her told her took lots of water and Tylenol so she took Tylenol, she took 2 pills of. Outcome of very tired was not recovered. lost her smell and her taste was recovered on 07Mar2021. Outcome of arthritis was unknown, and outcome of other events was recovering.
46 2021-03-30 tingling Within 3-5 minutes after my injection, my heart rate increased and my blood pressure increased. I b... Read more
Within 3-5 minutes after my injection, my heart rate increased and my blood pressure increased. I became very dizzy and my hands were tingling. I felt like I had tunnel vision, couldn't catch my breath. The nurse monitored my heart rate and then notified the rapid response team. While monitoring my blood pressure, they made the call to get ENT's to get me to the ER. I was in the ER for 5 hours for monitoring, iv fluids and testing.
46 2021-03-30 tingling 3/30/2021: Whole Body; Acute Myalgia, Acute Arthralgia, Acute Allodynia. Resting Tachycardia >3 hr... Read more
3/30/2021: Whole Body; Acute Myalgia, Acute Arthralgia, Acute Allodynia. Resting Tachycardia >3 hrs, fever between 101-103. Symptoms began approx. 12:00pm and began to subside when awoke the following morning at 9:00 am 3/31/2021: Full left arm paresthesia. Symptom began approx. 9:00 am when awoke.
46 2021-03-30 tension headache Pt with onset of HA and SOB. HA and SOB became so severe she called 911 to get transported to the ED... Read more
Pt with onset of HA and SOB. HA and SOB became so severe she called 911 to get transported to the ED on AM of 3/31/21. Does have hx of Migraines. Has been non-complaint with Migraine prevention meds. But reports this HA feels different and is more severe.
46 2021-03-30 tremor, flushing feeling uneasy; BP was 150/80; confused; anxiety; flush through my whole body; shaking; didn't feel ... Read more
feeling uneasy; BP was 150/80; confused; anxiety; flush through my whole body; shaking; didn't feel "right"/felt funny; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), via an unspecified route of administration on 19Feb2021 (at 46 years old) as single dose for covid-19 immunisation. Medical history included ongoing hypotension and ongoing hoshimoto's disease. The patient's concomitant medications were not reported. The patient experienced feeling uneasy, bp was 150/80, confused, anxiety, flush through her whole body, shaking, didn't feel "right"/felt funny all on 19Feb2021 with outcome of unknown. The HCP told patient to take a diphenhydramine hydrochloride (BENADRYL) beforehand, and her cardiologist also provided her with a prednisone dosepak. Clinical course was reported as follows. About 10 minutes after receiving her first dose, the patient reported reactions that "hit her so hard, out of no where" including flushing throughout her entire body, shaking, feeling uneasy like "something is happening". She tried to cool herself down by taking off her coat. She did not require an epipen. When EMS arrived, her BP was 150/80 mmHg which is out of character for her, as she normally has a BP of 80/40 mmHg (very low, almost "Dead"). She also reports that she "didn't feel right" for the rest of the week following vaccination. She was very confused, didn't feel "right" and had these anxiety/felt funny for a week afterward. She also reported having Hoshimoto's disease. The people at the vaccination site thought maybe it was anxiety or a panic attack. She was nervous about receiving her second dose on 12Mar2021.
46 2021-03-31 pain in extremity On 3/30/2021 Bronco spasm after 30 minutes of inoculation. He felt a tight chest, severe pain in the... Read more
On 3/30/2021 Bronco spasm after 30 minutes of inoculation. He felt a tight chest, severe pain in the right lung, disorientation, headache, dizziness, and itchy throat. Quick use 2 inhalers: Albuterol Sulfate HFA and Symbicort. Also take 2 Benadryl 25mg. The next day 3/31/2021, use the inhalators preventively. Headache and muscle pain continued on 3/31/2021 and I took 2 Tylenol 600mg every 4 hours. On 4/1/2021, headache, muscle pain, and breathing problems decreased. At the moment there is mild pain in the head, arm and muscle.
46 2021-03-31 pain in extremity 3/24 - felt slight swelling in throat but subsided; 3/25 - sore arm for4 days; fever above 101 on 3/... Read more
3/24 - felt slight swelling in throat but subsided; 3/25 - sore arm for4 days; fever above 101 on 3/25; neck ache and head ache on 3/25; tired on 3/25
46 2021-03-31 tingling day 2 post vaccine ear fullness started and continues, day 7 post vaccine tinnitus in both ears alo... Read more
day 2 post vaccine ear fullness started and continues, day 7 post vaccine tinnitus in both ears along with facial tingling on right side and around eye. the tinnitus is still 11 days post vaccine along with ear fullness.
46 2021-04-01 weakness Beginning 6 hours after, extreme fatigue, brain fog, weakness, arm pain at injection site, loss of a... Read more
Beginning 6 hours after, extreme fatigue, brain fog, weakness, arm pain at injection site, loss of appetite, nausea, mild sporadic chest pains, loss of breath once. Felt all this for 24 hours. Arm pain, chest pains, loss of breath decreased after 24 hours. Brain fog, weakness, fatigue started to decrease after 48 hours. I am still having fatigue, weakness and GI issues like loss of appetite, nausea and going to the bathroom frequently. I want to hold off on my 2nd shot for several weeks.
46 2021-04-01 muscle spasms Severe muscle cramps both legs simultaneously effecting equally my calf muscles, shin splints, both ... Read more
Severe muscle cramps both legs simultaneously effecting equally my calf muscles, shin splints, both feet & toes. Came on suddenly, could not walk it off or stretch for relief & then just dissipated 5-7min later. Muscle soreness through the day after
46 2021-04-01 pain in extremity Sore arm, bad headache, chills, sore muscles, fatigue within 24 hrs
46 2021-04-01 tingling, feeling hot Patient returned to vaccination site within an hour after receiving their 2nd dose vaccination. Pt r... Read more
Patient returned to vaccination site within an hour after receiving their 2nd dose vaccination. Pt reported rash on chest that feels hot and tingly. Denied pain sob/aphagia. Pt was evaluated by EMS and released. Advised to call 911 or seek medical attention if problem worsens.
46 2021-04-01 tingling Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient presented with soarness in throat a couple of hours after administration. SHe was taken to the fire department (Uncertain about what treatment was conducted here). Next day, and patient is still not fully recovered. Still has scracthy throat and soreness in her throat.
46 2021-04-02 pain in extremity Arm pain, chills, headache, vomiting, fatigue, brain fog, joint pain and aches. Chills lasted a coup... Read more
Arm pain, chills, headache, vomiting, fatigue, brain fog, joint pain and aches. Chills lasted a couple hours. The rest approx. 8-12 hours.
46 2021-04-02 pain in extremity Sore arm, swelling at injection site, injection site hot to the touch, fatigue, low grade fever, bod... Read more
Sore arm, swelling at injection site, injection site hot to the touch, fatigue, low grade fever, body aches. Advil used as treatment.
46 2021-04-02 tingling, numbness Headache, chills, fatigue, numbness and tingling on both arms and hands, and left leg. I took Tyle... Read more
Headache, chills, fatigue, numbness and tingling on both arms and hands, and left leg. I took Tylenol to treat my symptoms, but I'm still in pain.
46 2021-04-03 bell's palsy Bell's Palsy on the right sde
46 2021-04-03 discomfort, slow speech, tingling, flushing, slurring She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. S... Read more
She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. She ended up getting a cardiac catheterization while she was there which was normal. The day prior to this she had actually received her second Covid vaccination in her left arm. She noticed achiness and soreness across her shoulders bilaterally into her chest and into her neck. She had some subjective fevers and chills and felt generally fatigued. She also had a lot of swelling in her left axilla and she ended up getting a CT scan during her workup which revealed some left axillary adenopathy. She returned to the ER on 3/16: while brushing her teeth, she developed right facial paresthesias that marched over approximately 20 minutes to involve the right arm and the right leg. She went to the hospital. She was seen in the ER. They felt this represented possible ischemia. They gave her tPA. She had a hemorrhagic nosebleed. Did not develop any other signs of bleeding. Her symptoms had not resolved. She was discharged from home. She had a headache at the time of her visit to the ER. Her headache had resolved by the time she was discharged home, but she continues to note paresthesias in the right side of her body, right face, and notes over the last day or 2, she has had increased dysarthria, dizziness and slurred speech, brain fog, a sensation of heaviness and inability to think. She states she currently does not have head pain per se, but she does note that she just feels generally poorly. She feels like her brain is working faster than her mouth muscles are. She is in today for neurologic followup, concerned about these ongoing issues. she continues to struggle with her speech feeling quite slow and deliberate, she feels like it is difficult for her to concentrate, she is forgetful, she still has intermittent episodes of paresthesias in her face, arm, and hand, she feels like she becomes heart and flushed and she has some heart rate variability with her heart going slow and fast, and she has significant disequilibrium. She is extremely fatigued where she is only able to get up for 1-2 hours before she is extremely fatigued and has to go back to bed.
46 2021-04-03 numbness Numbness in right arm down to my fingers for 24 hours
46 2021-04-03 tingling, pain in extremity Arm pain for 48 hours; Some tingling down to fingertips; This is a spontaneous report from a non-con... Read more
Arm pain for 48 hours; Some tingling down to fingertips; This is a spontaneous report from a non-contactable consumer. A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL8982; expiration date not reported), via an unspecified route (administered on right arm) at the age of 46-years-old on 21Jan2021 01:45 PM as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included rosuvastatin calcium (CRESTOR) and levothyroxine sodium (SYNTHROID) both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient is not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient experienced arm pain for 48 hours and some tingling down to fingertips on 21Jan2021 05:00 PM. Therapeutic measures were taken as a result of the events included ibuprofen and Tylenol. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered/resolved. No follow-up attempts are possible. No further information is expected.
46 2021-04-04 weakness injection was administered at about 7:00pm; symptoms began during the night... started feeling uncom... Read more
injection was administered at about 7:00pm; symptoms began during the night... started feeling uncomfortable aches and pains, by early morning symptoms of fever, muscle aches, joint aches, overall pain and hypersensitivity, nausea. Treatment - sleep; slept and drank fluids for about 24 hours Fever reached about 102.2 on 4/2 at around 3:00am and broke shortly after that Continued sleep and fluids until about 10:30 on 4/2 Slowly regained energy and able to stay awake as usual from about noon on 4/2 onward. Slight weakness until 4/3. Strong headaches and aching eyes on 4/3 and 4/4 4/5 - back to mostly normal
46 2021-04-04 burning sensation 2 minutes after injection patient reported burning feeling in body. Topical non macular rash appear... Read more
2 minutes after injection patient reported burning feeling in body. Topical non macular rash appeared on R lower arm, reports itchy feeling on skin generalized. VS WNL. No SOB, respiratory distress, or site reaction symptoms noted. No throat swelling or tingling. Patient observed and Dr. notified. No treatment necessary.
46 2021-04-04 facial paralysis, tingling, numbness Mild left sided facial paralysis one hour after receiving vaccine, lasted for approximately 24 hours... Read more
Mild left sided facial paralysis one hour after receiving vaccine, lasted for approximately 24 hours. Continues to have intermittent numbness and tingling to left side of face since that time, though paralysis has not returned. No other neurological symptoms. Vaccine not performed by this provider or at this clinic.
46 2021-04-04 feeling of insects crawling on skin 1/21 vaccination Ten minutes after vaccine, felt like something crawling all over my. SOB, went to t... Read more
1/21 vaccination Ten minutes after vaccine, felt like something crawling all over my. SOB, went to the ER they gave steroid injections and Benadryl. Woke up that evening and I had SOB. I took EPI pen, transferred to ER and administered another EPI pen with steroid pack. Third visit was to the Urgent care; administered steroid pack. Fourth visit with PCM
46 2021-04-04 migraine General body aches first four days following vaccination. Migraine type headache five days following... Read more
General body aches first four days following vaccination. Migraine type headache five days following vaccination. Fever from 104f first two days following vaccination to 102f days three and four following vaccination. Nausea with vomiting and inability to keep down fluids or eat days 1-4 following vaccination.
46 2021-04-04 migraine Patient had peripheral vision problems and some anxiety. The worst side effect is the severe migrai... Read more
Patient had peripheral vision problems and some anxiety. The worst side effect is the severe migraine headache she has had for 8 days and counting since she got the vaccine. She has a history of migraines but this one was untreatable and extended into her optic nerve. It was also on both sides of her head rather than just one (which is how it normally is). She went to the emergency room where they can usually treat it. However, this time, their treatment did not work. She said she also has a hard time finding words and is feeling more fearful when she rides her motorcycle. She does not want to ride her motorcycle right now, due to these vision problems and anxiety.
46 2021-04-04 tingling, bell's palsy On Monday, March 29, I woke up with the right side of my face frozen and not working.
46 2021-04-04 tingling Patient reorted tingling sensation from shoulder down arm and up side of head, on right side. Same s... Read more
Patient reorted tingling sensation from shoulder down arm and up side of head, on right side. Same side that vaccine was given, right deltoid. Began 7 minutes after vaccination while patient was in the observation area. MD on site and assessed patient. Plan is to monitor for 30 minutes. After 10 more minutes, patient reported tingling in her throat. MD ordered Cetirizine 10mg (Zyrtec) once now. Given to patient at 1255 pm. Vaers info gathered from pateint. 30 min of observation done. Patient feeling well, no swelling nor shortness of breath. MD assess her and discharged her home.
46 2021-04-04 tenderness The day after the vaccination, at 10:00am, I began feeling poorly. I was fatigued, developed a feve... Read more
The day after the vaccination, at 10:00am, I began feeling poorly. I was fatigued, developed a fever, had chills, cough, runny nose, watery eyes, body aches, shortness of breath, headaches, loss of appetite, brain fog.. Slept 16 hours that night through the following day. Still felt bad, but could eat. Symptoms were still present but decreased in severity. Maintained a headache for four days. Arm at injection site is still hurting (tender to the touch) and swollen. Symptom free by 4/5/2021 except for arm being sore and tender. Previously had virus in July 2020. Felt like all the same symptoms including a few new ones. Did not go to doctor.
46 2021-04-05 weakness Reported SOB, weakness, fatigue. Patient return back to the clinic. Dr. consulting the patient at 10... Read more
Reported SOB, weakness, fatigue. Patient return back to the clinic. Dr. consulting the patient at 10:00AM. Patient stay additional 30 min. She was stable and doctor sent her home 10:30 AM.
46 2021-04-05 pain in extremity, discomfort Increased muscle aches in both arms, despite receiving 1st + 2nd shots only in the same (R) arm. Dif... Read more
Increased muscle aches in both arms, despite receiving 1st + 2nd shots only in the same (R) arm. Difficulty lifting arms, overall body fatigue and heaviness. By 5:00pm, I had chills, enough to require a sleeping bag inside a warm home. Symptoms felt notable in that they began 5 days following my booster shot to which I had no prior adverse reaction. Symptoms disappeared within 12 hours. Following my first vaccine shot on 3/10/21 (Pfizer EN6207), I developed same-day injection-site soreness, brain fog, fatigue and a splitting headache (extremely rare) 24 hours after receiving the shot.
46 2021-04-05 pain in extremity Sore arm 5 days later threw up for 3 hours straight
46 2021-04-06 flushing, tingling Flushing and tingling feeling; pt left and came back about ten minutes after she left; vitals were n... Read more
Flushing and tingling feeling; pt left and came back about ten minutes after she left; vitals were normal and was told to take Benadryl and monitor herself
46 2021-04-06 numbness, pain in extremity, breast pain March 24-26: Pain in left arm March 27-April 2: Mild numbness on left side of upper body - starting ... Read more
March 24-26: Pain in left arm March 27-April 2: Mild numbness on left side of upper body - starting at left shoulder blade March 3-Current: Tenderness/soreness under left armpit area and left breast. Painful sores/breakout on left side of left breast
46 2021-04-06 pain in extremity, bell's palsy, numbness Bells Palsy; Swelling in head/swelling from vaccine; headache; dizzy; sore arm; numbness left side o... Read more
Bells Palsy; Swelling in head/swelling from vaccine; headache; dizzy; sore arm; numbness left side of face; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 18Mar2021 13:00 (at the age of 46-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health clinic facility. No other vaccine in four weeks. The patient received the first dose of bnt162b2 (lot not reported) in left arm on 24Feb2021 at 14:00 (at the age of 46-years-old) for COVID-19 immunization. Medical history included known allergies: Sulfa. The patient's concomitant medications were not reported. The patient did not have covid prior vaccination and was covid tested post vaccination by nasal swab on 03Mar2021 with result of negative. The adverse events were swelling in head, headache, dizzy, sore arm, numbness left side of face and Bells palsy, all on 19Mar2021 at 01:00. On day 4, went to hospital no stroke or heart attack was told swelling from vaccine. The events were reported to have resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 1 day. Treatment for the events included pain meds, nausea meds. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-04-06 pain in extremity 01/17/2021 Pain in Right opposite of the arm got vaccination in 01/18/2021 felt a lump and had spott... Read more
01/17/2021 Pain in Right opposite of the arm got vaccination in 01/18/2021 felt a lump and had spotting bleeding . Unusual hormonal changes after the shot. Dr. seemed unconcerned. Sen to the Breast Specialist and she is schedule for a diagnostic mamma gram.
46 2021-04-06 pain in extremity Chills Aches Headache Dizziness Frequent urination Severe sore arm
46 2021-04-06 seizure like phenomena, unresponsive to stimuli Immediately following administration, patient appeared to be slumped into the chair, unresponsive to... Read more
Immediately following administration, patient appeared to be slumped into the chair, unresponsive to verbal cues. Patient began making seizure-like movements a couple of seconds later. That episode lasted 2.5 minutes - timed by attending RN. Mobile response team called. Patient responsive when mobile response team arrived. Obeyed commands but appeared lethargic.
46 2021-04-06 tremor, flushing towards end of monitoring time post vaccine, c/o feeling shaky, having visual disturbances, nausea, ... Read more
towards end of monitoring time post vaccine, c/o feeling shaky, having visual disturbances, nausea, and headache. brought back to obs 1722, 1724 bp 134/78 hr 71 rr 18 sao2 99% on ra. patient laying on stretcher, feeling relief of headache, flushing, and lightheadedness, but headache remains, though improved. 1730 bp 120/81 hr 73 rr 18 sao2 99% on ra, s/s improved, head pressure relieving, and visual disturbances improved. patient sitting up on side of bed at 1745 bp 124/75 hr 75 rr 20 sao2 99% on ra, denies increased s/s with standing. agrees stable to be escorted to personal vehicle, no further issues
46 2021-04-06 tremor Patient reported feeling dizzy, anxiety, trembling hands, and a mild headache. Patient was hypertens... Read more
Patient reported feeling dizzy, anxiety, trembling hands, and a mild headache. Patient was hypertensive, tachycardic, and afebrile. Blood glucose within goal.
46 2021-04-07 weakness, feeling hot, feeling cold Headache - feels like my brain is swollen and ready to blow up, stiff neck, collar bone pain, hands... Read more
Headache - feels like my brain is swollen and ready to blow up, stiff neck, collar bone pain, hands and veins feel swollen, feet feel swollen, feel hot inside, sweaty at night, cold when I uncover, cold with no socks, dizzy, threw up, stomach feels gassy and swollen, back hurts, painful to inhale, out of breath, weak, tired, can't sleep, dry phlemy cough, watery nose, watery sticky eyes....my brain feels like it's gonna blow up.... did I say MY BRAIN FEELS LIKE IT'S GONNA BLOW UP!!!!!!
46 2021-04-07 discomfort, migraine Dizziness - like I was drunk and had no alcohol. My back and hips started to ache. I was on a bike r... Read more
Dizziness - like I was drunk and had no alcohol. My back and hips started to ache. I was on a bike ride and I felt like I couldn't get enough air, like an elephant was sitting on my chest. I felt weighted down like a lead vest was on me. The fatigue has lasted 4 days. Nausea. Shoulders and neck are achy. After the first shot three weeks ago, I had a migraine and nausea for three days and these symptoms I just described.
46 2021-04-07 flushing Pt received the COVID vaccine {Pfizer, lot # EN6202 and exp date 06/30/2021 at (1319)}. EMT observed... Read more
Pt received the COVID vaccine {Pfizer, lot # EN6202 and exp date 06/30/2021 at (1319)}. EMT observed patient return to observation area after completing required 15 minute observation period. EMT and RN co-lead responded when patient stated she felt, "shakey, flushed", had a "knot in her stomach", and her, "throat felt tight". Patient's vitals were immediately taken and had a BP of 138/82 with a HR of 106 bpm. As patient was still able to converse with staff, patient was given 50mg of PO Benadryl and was placed in the zero-gravity chair at 14:03. At 14:09 the patient's BP was 138/82 and was visibly less flushed. Then at 14:16 the patient's HR was 89 bpm and her BP was 126/72 at 14:30. Patient verbalized feeling safe, was alert and oriented x3 and left with her husband who drove the couple home from the facility at 14:34. Throughout encounter patient was offered EMS several times and patient continually declined EMS services as her husband was, "on his way".
46 2021-04-07 mild one side paralysis, pain in extremity, facial pain, tingling Hives few hours after vaccine - resolved with OTC Benadryl. Fever of 101. Tingling of right side of... Read more
Hives few hours after vaccine - resolved with OTC Benadryl. Fever of 101. Tingling of right side of face, right arm, right hand,right leg. Weakness of right arm, right hand, right leg. Achy right face, right arm, right hand, right leg. Drooling right side of mouth at night. Fatigue. Patient reports symptoms have been constant for past 3 weeks. Patient states that she feels like she can not function with these symptoms.
46 2021-04-07 migraine Approximately 6 hours after receiving the vaccine, I had a sudden sharp throbbing migraine in the lo... Read more
Approximately 6 hours after receiving the vaccine, I had a sudden sharp throbbing migraine in the lower back of my head, slightly to the left. I took ibuprofen. Over the course of about 5 minutes, the pain increased to the point I would have gone to the ER if I had someone to drive me. The pain was debilitating - at level 8. I could only hold my head and walk slowly around the room to distract myself from it. I was at that level of pain for about 5-10 minutes. About 25 minutes after the migraine started, it became tolerable - more like a level 5/6. About 3 hours later it was at a 3/4. The throbbing didn?t go away until after I got a shot of Tiraspol at the urgent care the next day. I continued to have a low pain constant dull headache until 4/1.
46 2021-04-07 night sweats 8-9 hours after second vaccination started to experience extreme abdominal pain. Could not sleep be... Read more
8-9 hours after second vaccination started to experience extreme abdominal pain. Could not sleep because of pain. Was awake for nearly 30 hours because abdominal pain was so extreme. Began to vomit approximately 10 hours after second vaccine. Very frequent within first 24 hours, then developed vomiting and diarrhea at same time. Had fever, confusion and fatigue in days following. Woke up every night since vaccine (excluding first night of zero sleep) covered in sweat, feels like skin is on fire at times. Today day five, still exhausted but seems to be improving.
46 2021-04-07 pain in extremity, feeling hot First shot (administered on 5 Mar 21, Pfizer Lot# EN6198) only had injection site tenderness (appear... Read more
First shot (administered on 5 Mar 21, Pfizer Lot# EN6198) only had injection site tenderness (appeared next day) and arm pain which lasted for 2 days. Second shot reaction, in order of symptom appearance; Injection site pain - within minutes of the injection Arm pain when lifting above shoulder level - within approx. 2 hours Exhaustion - started approx. 3pm Headache - started approx. 5pm and varied in intensity throughout symptoms. Chills (to the degree that a warm bath was required to heat extremities) - started approx. 7:30pm, interfered with sleep before soaking in hot water at approx. midnight. Diminished after soaking although chills did alternate with being overheated throughout the night. Mild joint pain - started approx. 7:30pm. Was worse in fingers/wrist and ankles where there are pre-existing joint issues. Nausea - started approx. 11pm. Did not advance to vomiting. Fever - temperature was elevated, 99.5F, around 12:45am and increased to 101.9F at 0345, at which point Tylenol was taken. Temperature bounced around between 99.0 and 100.5 until the morning of the 28th. Other symptoms decreased (except fatigue) and were pretty much gone by approx. 5pm on 27 Mar 21.
46 2021-04-07 pain in extremity Joint Pain, Pain at injection site, diarrhea, arm pain.
46 2021-04-07 pain in extremity Patient complains of hallucinations a few times throughout the day on the day after receiving vaccin... Read more
Patient complains of hallucinations a few times throughout the day on the day after receiving vaccine. On the evening she received the vaccine, she experienced arm and shoulder pain and severe headache/pain above the eyes.
46 2021-04-07 tremor After receiving dose of COVID vaccine, patient reported difficulty breathing and became shaky. Pati... Read more
After receiving dose of COVID vaccine, patient reported difficulty breathing and became shaky. Patient was transferred to wheelchair, given water and ice and was transferred by an RN to the ED. Per ED MD, patient developed throat tightness, nausea, fluctuance a shin after COVID vaccine. Concern this could represent of a allergic reaction. Less likely vasovagal reaction as throat tightening would be very atypical. There were no signs of any angioedema, she has no rash, no wheezing, no chest pain. At this time she does not have signs of anaphylaxis. Patient's symptoms have completely resolved by the time of evaluation. Per MD, this could have been allergic reaction to the vaccine and therefore would not recommend that she received a 2nd dose. She is recommend to follow up with her primary care physician for re-evaluation and to discuss other options for vaccine.
46 2021-04-07 unresponsive to stimuli, difficulty speaking, seizure post vaccine observation session, patient complained of throat tightness/trouble swallowing and voic... Read more
post vaccine observation session, patient complained of throat tightness/trouble swallowing and voice became raspy. patient has multiple reported allergies and carries epipen. Received 2 doses of epi IM and one dose Benadryl prior to arrival in EC, for throat and tongue swelling again. At triage, sleepy, on transfer to floor became unresponsive and noted to be seizing (received 3 doses ativan) with no resolution, subsequently intubated for airway protection and transferred to ICU.
46 2021-04-08 flushing -itchy all over - started on soles of feet but is now all over - hands, tummy, back. Degree of itch... Read more
-itchy all over - started on soles of feet but is now all over - hands, tummy, back. Degree of itchiness is bothersome, yet not intolerable. -tingling of lips and tongue - no swelling of lips or tongue noticed -flushing at chest, neck, and face (flushed in color and skin is warm to the touch) Planning to take some benadryl soon to attempt to curb itching. Had taken Tylenol at 6pm and then again at 10pm (4/8). 4/9 took daily prevacid and atorvastatin as usual in the morning.
46 2021-04-08 tingling, numbness After first shot I had tingling on the back of my tongue. It went away later that day. The second sh... Read more
After first shot I had tingling on the back of my tongue. It went away later that day. The second shot I had tingling later that day and had a headache but it went away the next day. April 2 woke up with tingling on my tongue and then I couldn't taste anything plus a bad headache. Around 4 pm I went to ER because my lip started to pull to the side and I still didn't have any taste and my tongue was tingling more. My lips started to feel numb along with the side of my face. I went to ER and was sent to hospital for a MRI by ambulance.I was told I have Bells Palsy and was giving steroids to take for 5 days and to see my dr.
46 2021-04-08 tingling, pain in extremity, migraine Tightness on left side of throat Dizziness, vertigo, headache/migraine High fever (101-102.3), chill... Read more
Tightness on left side of throat Dizziness, vertigo, headache/migraine High fever (101-102.3), chills, sweats Severe body aches (stabbing pain in joints and lower back) Pain and tingling in left arm
46 2021-04-08 tingling Patient felt dizzy and had tingling in hands
46 2021-04-09 facial pain, flushing Dizzy, Pain in joints, smell changed, taste, headache, pain in eyebrow, hallucinations, flushed
46 2021-04-09 pain in extremity I got the 2nd vaccine on 4/09/2021. Than I woke up the next morning and arm was sore, through out t... Read more
I got the 2nd vaccine on 4/09/2021. Than I woke up the next morning and arm was sore, through out the day arm became itchy, red swollen, blisters, hot to the touch and very sore. This was around 1pm on 4/10/2021.
46 2021-04-09 pain in extremity Severe pain in left arm, from the shoulder to the elbow of left arm felt heavy and very painful for ... Read more
Severe pain in left arm, from the shoulder to the elbow of left arm felt heavy and very painful for two days. I started my menstrual cycle the day after the vaccination - two weeks early. I am on birth control and my dates have not varied in twenty years until this time. It has been an abnormally heavy cycle with very painful cramps this time too - things which I have not had since I was in my early twenties (and never since I have been on birth control).
46 2021-04-10 burning sensation, tingling, pain in extremity 7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the nig... Read more
7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the night, it wouldn?t go away,, with pins and needles itching all day. Then again the following night (last night) my feet burned all night. In hindsight, I had had a very bad reaction after the second shot on 4/2 that started the night of the shot, when I woke up at 3 am feeling like my feet, legs and entire body was burning, then Saturday I had a high fever all day, 103.8, chills, burning sensation on and off, chest pain, heart pain, which I treated first with Tylenol then Motrin. It was a horrible two nights, but by Sunday 4/4 I was fine. I have been fatigued all week but didn?t think much about it. Then Friday night into Saturday of exactly a week after the second shot, this has happened. The burning sensation on my feet is intolerable and I haven?t slept for two nights.
46 2021-04-10 numbness, tingling Woke up at 2:30 am the morning after the shot. My hands and arms were tingling and my legs were numb... Read more
Woke up at 2:30 am the morning after the shot. My hands and arms were tingling and my legs were numb. It resolved but recurred at 3:30 am today 4/11/21. I awoke with stomach pain., leg numbness and tingling in my arms and hands.
46 2021-04-10 numbness, tingling Numbness/Tingly/Pins and Needles sensation for over 24 hours starting two hours after shot. Sensati... Read more
Numbness/Tingly/Pins and Needles sensation for over 24 hours starting two hours after shot. Sensation was felt in face, lips, arms, hands and legs. Took Benadryl at hour 18 and feeling finally subsided.
46 2021-04-11 weakness, tingling 134 pm, c/o not feeling well, feeling faint 116/78, laid down, weak and dizzy. Reports history of ... Read more
134 pm, c/o not feeling well, feeling faint 116/78, laid down, weak and dizzy. Reports history of lupus, and possible mass cell activation syndrome. Allergic to bactrim, black pepper, nutmeg- carries epi pen. C/o tightening in throat, red in face, but no shortness of breath, some occasional coughing. 1:36 tingling of R arm where vaccine was given. 128 pm b/p 118/86, 98%, 86 HR, coughing some, and tingling of face, hands, and arm. 1:48 pm b/p 116/78, 95% O2, 81 HR, still some coughing, SOB, shaking- face not as red. R arm, hand, and face numb. 1:46 Attempt to call MD. Tried water, c/o dizziness. 1:51 pm Resp. more labored- coughing more. 1:52 benadryl 50mg, in L arm. 1:54pm breathing slowed down, pulse ox 100%, says throat starting to feel better. 158 pm 102/70 b/p, 98% O2, 78 HR, 20 RR, Both hands, arms, and face numb. 208 pm- 98% O2, says throat is feeling better. 2:15- sitting- feeling a little dizzy. After 5-10 minutes she felt good enough to leave. Instructed to call 911 if anything returned or worsened.
46 2021-04-11 breast pain After dose 2, I had my menstrual cycle start one day later, which was one week earlier than it shoul... Read more
After dose 2, I had my menstrual cycle start one day later, which was one week earlier than it should have come. Separately, I had a sharp pain for 24 hours in my left breast. It has been reported that I have intramammary lymph nodes, and may have been associated with that.
46 2021-04-11 hot flush, migraine, tremor The night of the injection came home extremely fatigued and tired immediately went to bed. Next morn... Read more
The night of the injection came home extremely fatigued and tired immediately went to bed. Next morning woke up trying to go to work with extreme fatigue migraine and dizziness. My condition got worse I was unable to eat or drink, severe nausea, shaking since there is a light sensor it at all sound severe hot and cold flashes. My stability and gate was off so I could not stand or walk by myself without holding onto a wall. This lasted for about a month. I am still having problems
46 2021-04-11 pain in extremity AE started about 10 to 12 hours after injection. Developed in order- sore arm, chills, body aches, ... Read more
AE started about 10 to 12 hours after injection. Developed in order- sore arm, chills, body aches, severe headache, fatigue, fever. All symptoms resolved in about 48 hours.
46 2021-04-11 tingling Tingling throughout body, facial edema (cheeks) with redness noted, throat tightening, difficulty br... Read more
Tingling throughout body, facial edema (cheeks) with redness noted, throat tightening, difficulty breathing
46 2021-04-11 tenderness, burning sensation My feet started itching three days after shot and then I seen my sling began sloughing off. The next... Read more
My feet started itching three days after shot and then I seen my sling began sloughing off. The next morning my feet are burning uncontrollably and still real tender
46 2021-04-12 feeling hot overwhelming since of hotness; Dizziness; broke out in a rash everywhere; heart rate went up; This i... Read more
overwhelming since of hotness; Dizziness; broke out in a rash everywhere; heart rate went up; This is a spontaneous report from a contactable Nurse. This female Nurse reported for herself that a 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot no: EP7534, Expire Date: 31Jul2021), 0.3ml intramuscular injection in left deltoid as a single dose for covid 19 immunisation on 26Mar2021 at 1:00PM. The patient medical history included blood pressure, migraine. The patient concomitant medication included Amitriptyline 100mg once a day for Blood pressure, Amlodipine Besilate at 5mg every day for Migraine, Sumatriptan (Sumatriptan)100mg as needed for Migraine. The patient received the first dose of Pfizer COVID19 vaccine on 26Mar2021 and had an immediate reaction. She needed 50mg of Benadryl, within 15 seconds of the vaccine. she had an overwhelming since of hotness and did not last very long, maybe 3 seconds and It washed over her. The feeling like she was going to pass out came after the overwhelming since of hotness. They put her feet up and put on nasal cannula with 2L of oxygen. The feeling like she was going to pass out came and went with the dizziness. She was dizzy on and off for 30 minutes. The rash started immediately, and It went away about 5 o'clock that evening and the Heart rate went up: it was 122 beats per minutes on 26Mar2021. It came down back to normal within an hour. All the events were assessed as medically significant. The outcome of felt like she was going to pass out, overwhelming since of hotness, Dizziness, broke out in a rash and heart rate went up was recovered on 26Mar2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-04-12 hot flush HEADACHE, NAUSEA, CHILLS, HOT FLASHES, FEVER, LOSS OF APETITE, BODY ACHES TOOK ADVIL EVERY 12 HOURS ... Read more
HEADACHE, NAUSEA, CHILLS, HOT FLASHES, FEVER, LOSS OF APETITE, BODY ACHES TOOK ADVIL EVERY 12 HOURS CALLED OFF WORK DUE TO ILLNESS ON MONDAY 4/13/2021, RETURNED TO WORK 4/13/2021
46 2021-04-12 numbness, tingling she had numbness and tingling on the left side of the face, then her left arm; she was tired and sle... Read more
she had numbness and tingling on the left side of the face, then her left arm; she was tired and sleepy; she was tired and sleepy; she felt a bit tingling in her right ankle; tingling on the left side of the face; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 subcutaneous, administered in left arm on 27Mar2021 09:15 (Lot Number: EP6955) as single dose for covid-19 immunisation at age 46 years old. Medical history was not reported. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included unspecified medications received within 2 weeks of vaccination. No other vaccines received within 4 weeks prior to COVID vaccine. The patient got the vaccine Saturday 27Mar2021, she felt a bit tingling in her right ankle in the evening. On Sunday, 28Mar2021, she was tired and sleepy. On Monday, 29Mar2021, around 10:00 she had numbness and tingling on the left side of the face, then her left arm. She called her primary care doctor and she was directed to go to urgent care. She went to urgent care and the doctor sent her to the emergency room then she was admitted to the hospital. Multiple tests were done, CT-Scan, MRI, echo results came back negative and everything looked fine. She was discharged from the hospital Tuesday 30Mar2021. The patient was tested for COVID (nasal swab) post vaccination on 29Mar2021 with negative result. The patient recovered from the events. Information on the batch number has been requested.
46 2021-04-12 migraine headache, pain behind left eye, nausea, Dizziness, fever, chills, migrane, back rash and rash on pal... Read more
headache, pain behind left eye, nausea, Dizziness, fever, chills, migrane, back rash and rash on palms.
46 2021-04-12 numbness and pain in extremities, difficulty speaking skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphyla... Read more
skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphylactic reaction; my throat was closing; my tongue swelled up to the back of my throat; she experienced Body aches; At home she started wheezing; Dry cough; Hoarse voice; Upper airway swelling; Difficulty breathing (without wheeze or stridor); bronchospasm; Respiratory distress; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:30 as single dose for COVID-19 immunisation. Medical history included celiac disease and asthma. The patient had allergies to medications, food, or other products. Concomitant medication(s) (received within 2 weeks of vaccination) included levocetirizine dihydrochloride (XYZAL), Dexalant and birth control pill. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26 Mar2021, the patient experienced anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high, my throat was closing, she experienced body aches and at home she started wheezing/bilateral wheeze. Within minutes of receiving the vaccine, my tongue swelled up to the back of my throat and she had a weird sensation in her throat, 15 minutes later she was not able to form words. The patient was given liquid Benadryl (oral) for my tongue swelled up to the back of my throat and her symptoms resolved. She went to the nurse station, who took her BP which was high, which it normally is not so the treating physician felt confident in letting me go home. She was monitored for an hour and was sent home with no more tongue swelling. At home she started wheezing. She called her HCP and was advised to take a nebulizer with no effect. At around 14:00, when the Benadryl wore off, her throat was closing so she was directed to epi-pen herself and call 911. She was taken by ambulance to the hospital and treated for anaphylactic reaction to the vaccine. She was given prednisone 50mg by mouth daily for four days and a refill for her Epipen. No additional Epipen was administered. On 29Mar2021, the patient experienced skin hurting like a neuropathy, chills and she experienced a rash. On an unknown date in Mar2021, she experienced bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor). No sneezing or rhinorrhea. She was treated with adrenaline, corticosteroids, antihistamine, IV fluids, Oxygen, bronchodilators and other. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The administering doctor not to take the second vaccine. The outcome of the events anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high and my throat was closing was recovered with sequealae, skin hurting like a neuropathy, she experienced body aches, at home she started wheezing/bilateral wheeze, chills and she experienced a rash was recovered and bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor) was unknown. Follow up attempts are needed. Information on lot /batch number was obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-04-12 night sweats DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at... Read more
DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at ER
46 2021-04-12 pain in extremity Initial stomach discomfort beginning minutes after injection. 2-3 days of digestive issues most seve... Read more
Initial stomach discomfort beginning minutes after injection. 2-3 days of digestive issues most severely blood in stool that cleared up after a few days. Beginning around 4/3/21 began to have a sore between two toes along with redness and swelling and other redness in hands/wrists and around one eye. Doctor prescribed Antibiotic and antihistamine via tele-med video visit.
46 2021-04-12 tingling, tenderness Had minor ache in lower back (left side) on Thursday afternoon which stayed as an ache all night but... Read more
Had minor ache in lower back (left side) on Thursday afternoon which stayed as an ache all night but I couldn't get out of bed Friday morning. Finally able to leave bed on Monday with help but sore all that week and extremely tender. Two weeks later nearly today and still feeling it but mild. (light tingling on butt and outer thigh too). Maybe it was me and maybe it was exercise related but I did find a couple of people mentioning it on yahoo so thought I would mention it.
46 2021-04-13 pain in extremity 4/9 - Sore arm at injection site 4/10 - Sore arm, swollen lymph node in armpit of injection site, mi... Read more
4/9 - Sore arm at injection site 4/10 - Sore arm, swollen lymph node in armpit of injection site, mild itching around injection site and in armpit of injection site 4/11 - continuation of symptoms from 4/10 4/12 - continuation of symptoms from 4/10, itching subsided 4/13 - Swollen lymph node in neck on side if injection site
46 2021-04-13 pain in extremity severe arm pain, inability to move arm independently, muscle/body ache, fever, thunderbolt headache
46 2021-04-13 pain in extremity I'm just reporting since this was my 1st dose and it seems to be uncommon to have a fever with the f... Read more
I'm just reporting since this was my 1st dose and it seems to be uncommon to have a fever with the first dose. By 3:00pm on the day of the shot I had a fever of 100.4. It escalated to over 102 in the evening and then leveled off around 101 and stayed that way until around 4 or 5 am when the fever broke. Arm soreness was pretty intense until the fever broke and then was significantly improved. I had a headache, some mild nausea throughout the day after the vaccine. Headache and nausea were pretty strong on the 2nd morning after the vaccine and seem to be going away now in the afternoon. My arm is no longer sore on the 2nd day after vaccine.
46 2021-04-13 tingling, numbness Tingling and numbness noted around mouth 5 minutes after vaccine administered. Pepcid administered 2... Read more
Tingling and numbness noted around mouth 5 minutes after vaccine administered. Pepcid administered 2 minutes after symptoms noted and Zyrtec administered 20 minutes after symptoms noted. Patient waited a total time of 1 hour after vaccine administered and reported no increase or worsening in symptoms. Patient was instructed to go to the Emergency Department if symptoms worsen and to contact their primary care provider for follow up care.
46 2021-04-13 unresponsive to stimuli, seizure, tremor Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Addition... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: patient passed out and fell over and hit the floor face forward. bruised face and chipped tooth.911 was called and patient was taken to er. Not sure on final outcome. Called husband to check on patient and have not received a call back. will call again.
46 2021-04-14 burning sensation, weakness 5 minutes after receiving shot wave of dizziness and weakness. Head spinning, nausea. Burning in t... Read more
5 minutes after receiving shot wave of dizziness and weakness. Head spinning, nausea. Burning in throat and arm (opposite of arm that got the shot). Didn?t pass until almost an hour and a half later.
46 2021-04-14 muscle spasms Both lymph nodes under both arms been swollen for last two weeks but producing much burning pain and... Read more
Both lymph nodes under both arms been swollen for last two weeks but producing much burning pain and spasm in muscles in chest. And shivering inside at night in particular. Some shooting muscle pain in legs early on. Fading last day a bit. Had to get muscles relaxants and strong antiinflamatory but getting batter last day on just Tylenol. Had to get heart and chest X-ray but all looks normal. Saw doc twice. Believing it will get better soon as doc said it should subside bc had to postpone second shot til a week later April 26.
46 2021-04-14 muscle spasms Fever Aches Headache Stomach ache Muscle cramps Swollen lymph node in arm pit
46 2021-04-14 numbness and pain in extremities, tingling Within 2 days experienced increased intensity of neuropathy from 1-2/10 to 8/10 at times awakening f... Read more
Within 2 days experienced increased intensity of neuropathy from 1-2/10 to 8/10 at times awakening from sleep and limiting her ability to run (triathlete). Constant, daily pins/needles with regions of electrical impulses in lower legs
46 2021-04-14 pain in extremity Approximately 45 hours post-2nd Pfizer COVID-19 vaccination, first signs of a shingles vaccine rash,... Read more
Approximately 45 hours post-2nd Pfizer COVID-19 vaccination, first signs of a shingles vaccine rash, sore joint and leg pain on the left side of the body, as well as a headache were experienced. Later the same day, additional rash spots (2) were seen. Online urgent care used four days post-vaccination and shingles was diagnosed by nurse practitioner on duty at Virtuwell clinic.
46 2021-04-14 tingling, numbness Slight itching began within minutes, but it was minor. Itching was mid way down left arm and in face... Read more
Slight itching began within minutes, but it was minor. Itching was mid way down left arm and in face? chin area. Within 39 minutes, left side of face was numb with tingling sensation and lips were fully numb and tingly. Tongue felt swollen and itchy, as well. Symptoms lasted several hours. It is now more than a week later and there is still slight numbness in lips and on left side of face. No visible changes have been noticed, just the sensation of numbness as of given Novocain at the dentist.
46 2021-04-14 tingling Developed fatigue, myalgia, headaches, polyarthralgia and paresthesias 1-1.5 week after immunization... Read more
Developed fatigue, myalgia, headaches, polyarthralgia and paresthesias 1-1.5 week after immunization first dose 1/19/21
46 2021-04-15 cold sweat, slurring, cold extremities Pt c/o of light headedness while in observation. Pt had slurred speech, skin was cold and clammy, an... Read more
Pt c/o of light headedness while in observation. Pt had slurred speech, skin was cold and clammy, and pt had intermittent loss of consciousness. Maintained pt in a comfortable position until EMS arrived. BP 193/130, HR 124, O2 99%, RR 14.
46 2021-04-15 feeling cold, numbness Immediately felt dizzy and left side of body (leg, arm and face) went numb, then became super relaxe... Read more
Immediately felt dizzy and left side of body (leg, arm and face) went numb, then became super relaxed (had to remind myself to breathe), husband had to help me upstairs to bed. Cold chills during the night. Next day very dizzy and light headed, arm still numb and fatigue in evening. Following day work up normal but felt dizzy and lightheaded if moved around too much. One week later (today) feel very dizzy and light headed.
46 2021-04-15 feeling hot, tremor Around 2am Wednesday (34 to 36hrs after injection) I was aroused to a semi conscious state by sever... Read more
Around 2am Wednesday (34 to 36hrs after injection) I was aroused to a semi conscious state by sever trembling from chills where I could all so feel extremes heat coming from different areas on my body. I recall it felt as though someone was putting a hot compress on my leg, but the sensation would jump around. I had a sever headache localized in the center front. The following morning I had taken Tylenol for the headache and to reduce my fever, but I could not get my down to below 101.0(F) even with continues doses. Exhaustion, and mind fog all day.
46 2021-04-15 flushing, tingling, feeling hot, numbness Face felt flush, irritated by mask. But after mask was removed my face continued to appear red and f... Read more
Face felt flush, irritated by mask. But after mask was removed my face continued to appear red and feel hot to the touch (no fever). (Both sides). Swelling of face became more evident (mostly cheeks) over the next two hours.Flush areas of face also felt numb/tingly. Mouth also felt numb-teeth felt like after dentist anestheic injection. began about 10:50, peaked around 1pm maybe. By 4 felt mostly normal. Face stayed flush looking after no longer felt hot or numb. Just fatigue after. Also some swelling/numbness at site of injection. But more mild.
46 2021-04-15 numbness FACE AND TONUGE NUMBNESS 15 MINUTES AFTER ADMINISTRATION, WAS ADMINISTERED 50 MG OF BENADRYL, PROCEE... Read more
FACE AND TONUGE NUMBNESS 15 MINUTES AFTER ADMINISTRATION, WAS ADMINISTERED 50 MG OF BENADRYL, PROCEEDED TO HOSPTIAL JUST IN CASE, COUGH AND HEADACHE THE FOLLOWING DAY
46 2021-04-15 pain in extremity After 6 hours my left arm was hurting a lot. After that I got the chills and heavy fever (102.7). A ... Read more
After 6 hours my left arm was hurting a lot. After that I got the chills and heavy fever (102.7). A lot of headache, body aches and vomiting. I could not do anything else than staying in bed. Did not eat and was not able to take Tylenol or anything else. It last for a full 24 hours, fever and vomiting was gone, but after that I still had headaches.
46 2021-04-15 tingling, numbness I administered a Pfizer COVID19 shot to the patient as a first dose. I then had the patient go to th... Read more
I administered a Pfizer COVID19 shot to the patient as a first dose. I then had the patient go to the post vaccination waiting area to wait for the 15 minute post vaccination period. At about 7.5 minutes into the 15 minute time frame the patient approached the consultation window complaining of tightness in her throat and jawline, numbness and tingling in her face, and feeling faint. I administered 20ml of 12.5mg/5ml liquid diphenhydramine for a total of 50mg of oral liquid diphenhydramine. The patient then stated that the tingling was progressing to her extremities. I then administered 0.3mg epinephrine auto-injection to the outer aspect of the right thigh at 11:02am. 911 was called and a code white paged through the store. The patient continued to experience tightness in her throat and tingling and stated that it was worsening at 11:08am a second 0.3mg epinephrine auto-injection dose was administered to the outer aspect of her left thigh. Paramedics arrived on the scene at 11:09am and the patient was taken to the hospital. Patient remained responsive throughout.
46 2021-04-15 tremor Within 24 hours Fever 101+ Body aches Severe headache Skin fever Shakey Chills Joint pain Basically ... Read more
Within 24 hours Fever 101+ Body aches Severe headache Skin fever Shakey Chills Joint pain Basically full on acute Covid symptoms that hit hard and slowly dissipated over 4 days leaving me physically and mentally exhausted
46 2021-04-16 burning sensation, pain in extremity, numbness on 4/16/2021 @ 4:42AM I woke up with severe pain in my finger tips; swelling and burning (at the tim... Read more
on 4/16/2021 @ 4:42AM I woke up with severe pain in my finger tips; swelling and burning (at the time no redness). Today, 4/17/2021, my finger tips have painful red blisters on them (feels like they are on fire). Ring and Pinky fingers on my left hand are numb at the finger tips down to the second knuckle (on each finger). I have taken (1) 81mg children chewable aspirin this morning at 8:00AM; at 12:00PM I took (1) 500mg pill of Tylenol and repeated the Tylenol at 4:00PM & 10:00PM. They haven't worked at all with the fiery pain, swelling, nor the blistering redness on my finger tips.
46 2021-04-16 flushing Facial redness/ Flushing per patient - Tachycardia and Increased Blood Pressure (secondary possibly ... Read more
Facial redness/ Flushing per patient - Tachycardia and Increased Blood Pressure (secondary possibly to stress/nervousness)
46 2021-04-16 numbness Within minutes of the injection in my left upper arm, I noticed my fingers on my left hand were not ... Read more
Within minutes of the injection in my left upper arm, I noticed my fingers on my left hand were not functioning fully, kind of like trying to use your fingers after your hand has fallen asleep and is almost "awake" but not quite. About an hour later, I started noticing it hurt my arm socket to move my arm certain ways. Over the remainder of the night, it became increasingly worse, causing a sharp pain in the socket when I would move my arm at all, to the point where it was excruciating to try to undress for bed. At times, there was also a numbness or tingling that would go down my entire arm into my fingers, similar to what you feel after hitting your funny bone really hard. I was only able to sleep lying on my back...any other position was too painful in the socket. Today, the numbness and tingling in the arm and fingers has stopped, but the socket still has sharp pain to the extent that I've been keeping my arm stable against my body as much as possible (I feel no pain if I do that).
46 2021-04-16 throat numbness, tingling About 15-16 minutes after the shot I got elevetad heart rate, tingling and numbness in tongue and mo... Read more
About 15-16 minutes after the shot I got elevetad heart rate, tingling and numbness in tongue and mouth palate. I had left the facility so decided to walk outside. Hart pulse got better in about 30 minutes, but the tongue tingling stayed. About 1 hour after the shot, the tingling got more intense and spread on my face around my mouth and chicks. I felt intense burning above my lips, looked in the Mirror and saw that my upper lip was swallen and red. Went back to the vaccination site, and talked to a paramedic. She said to take Benadryl. It is now 1 week after the shot. Tingling and numbness are getting worse in my mouth and tongue. A doctor prescribed me coticosteroids. He said I should take then to prevent anafilactic shock from the vaccine. I still have the tingling. When tingling and numbness in tongue and throat starts increasing, I have a feeling that my throat is closing and it is difficult I breathe.
46 2021-04-17 facial pain 24 hours after shot,Body aches. & headache day of. After shot face swelling sore cheeks like I was h... Read more
24 hours after shot,Body aches. & headache day of. After shot face swelling sore cheeks like I was have an allergic reaction. Sleepiness
46 2021-04-17 flushing Known allergy to Ants. Syncope, Flushing/sweating, dizziness. Pt had an episode of syncope for a fe... Read more
Known allergy to Ants. Syncope, Flushing/sweating, dizziness. Pt had an episode of syncope for a few seconds. Complained of dizziness and itchiness. Gave 50mg PO Benadryl. VSS and released from vaccination site.
46 2021-04-17 hot flush, weakness Lowe grade fever, chills, hot flashes, then lack of energy, nausea, diarrhea, skin reaction spots, l... Read more
Lowe grade fever, chills, hot flashes, then lack of energy, nausea, diarrhea, skin reaction spots, lips swelling, wheezing
46 2021-04-17 tingling, numbness pt. c/o tingling and numbness of her toes up to her knee. This was the 2nd dose of COVID vaccine. ... Read more
pt. c/o tingling and numbness of her toes up to her knee. This was the 2nd dose of COVID vaccine. it was resolved and patient went home.
46 2021-04-17 cold extremities Fever,Chills ,sweating ,body pain , fatigue, cold hands and feet. Started that Friday afternoon afte... Read more
Fever,Chills ,sweating ,body pain , fatigue, cold hands and feet. Started that Friday afternoon after the vaccine was given and wasn?t completely gone until Sunday morning. At least it was a little bit faster recovery time than the first time!
46 2021-04-18 flushing Within about 20-25 minutes of receiving my 1st dose, I started to get flushed from my neck up throug... Read more
Within about 20-25 minutes of receiving my 1st dose, I started to get flushed from my neck up through my forehead and my face was BRIGHT red and my cheeks were very warm to the touch. The whole reaction lasted no more than 30-minutes.
46 2021-04-18 numbness Dizzy left arm numb, metallic taste, had to keep swallowing? Swollen glands under chin on neck
46 2021-04-19 numbness, seizure The night of receiving the vaccine I experienced an involuntary convulsion at the onset of sleep. A... Read more
The night of receiving the vaccine I experienced an involuntary convulsion at the onset of sleep. As this reminded me of a previous experience when I expect I experienced COVID I was afraid and fought hard to stay awake. However, I drifted off to sleep a second time and immediately experienced another convulsion. I stayed awake deliberately all night. Another night I awoke with a racing heartbeat. Again, a repeat of a previous experience approximately 1 year ago. Yet, another night I awoke and my arm was numb from shoulder to fingers. Also, a repeat of a prior experience. However, other than the fear these repeat experiences aroused I have had no other considerable effects. I am not sure if these experiences classify as adverse events but they did concern me sufficiently to submit for review and I have slight trepidation about taking the second dose. I have a teaching credential and I believe I need it if I wish to work in the school system. Thank you!
46 2021-04-19 numbness Patient arrived at Vaccine POD for 2nd dose of Pfizer and reported that after her 1st dose she had f... Read more
Patient arrived at Vaccine POD for 2nd dose of Pfizer and reported that after her 1st dose she had facial numbness on the right side of her face for 1 hour - about 4 hours after vaccine. Patient did not seek medical follow up. Symptom self resolved.
46 2021-04-19 pain in extremity Nausea, fatigue, unable to sleep, arm pain, body aches, headache
46 2021-04-19 pain in extremity 9-10 hrs after vaccination -- fatigue, sore arm;Events completely wore off overnight, after I slept ... Read more
9-10 hrs after vaccination -- fatigue, sore arm;Events completely wore off overnight, after I slept it off.
46 2021-04-19 pain in extremity Soreness in arm shortly after injection Next morning, tired, periods of dizziness and nausea Later i... Read more
Soreness in arm shortly after injection Next morning, tired, periods of dizziness and nausea Later in day next day, muscle soreness (primarily back muscles) No fever
46 2021-04-19 pain in extremity Initially after the shot I just had a sore arm. Then Monday I started having fever and fatigue
46 2021-04-19 pain in extremity Day of headache (Sun), that night sore arm, and next day some sleepiness, but that doesn't concern m... Read more
Day of headache (Sun), that night sore arm, and next day some sleepiness, but that doesn't concern me. What does it Thurs (~Day5) afternoon, it felt like my tongue was getting "thick" and pressing my back teeth, then I noticed that the lymph node on the left side of my throat began to really swell. It got really enlarged by Friday evening (~ Day 6) to the point that I wondered if I had tonsillitis - no pus/not strep. But being only on the left side (same as shot) and not both, I figured that it could be a reaction. Called my after-hours doctor on Sat who confirmed that this did sound very much like a reaction (not much to be found online) and nothing to be too concerned about unless it didn't resolve in a few days. Swelling went down significantly by Sat. a.m. and was back to normal by Sun (Day 8).
46 2021-04-19 tingling Pt received Pfizer Covid-19 vaccine 4/4/21 and starting 4/8/21 began to have low back pain with ting... Read more
Pt received Pfizer Covid-19 vaccine 4/4/21 and starting 4/8/21 began to have low back pain with tingling. Pt's pain became worse and lesion developed along her right trunk. She went to urgent care 4/11/21 and was diagnosed with shingles. Pt completed 7 days treatment with antiviral and symptoms have improved. She is delaying her second Covid-19 shot one week to allow for complete resolution of symptoms.
46 2021-04-19 cold extremities "Administered - 13:30 Adverse event started - 13:40 Patient had light headedness, palpitations, cold... Read more
"Administered - 13:30 Adverse event started - 13:40 Patient had light headedness, palpitations, cold hands. BP 155/97 -- > 159/90 -- > 149/89 (changed to high Fowler's position) -- > 120/69 (standing position), HR 85 -- > 87 -- > 69 -- > 81, RR 18, O2 100%, A&O x3. checked patient. At 13:38 same day, patient denied symptoms."
46 2021-04-20 weakness, tremor passed out and went completely unconscious; Nauseous; felt weak like someone sucked all her energy o... Read more
passed out and went completely unconscious; Nauseous; felt weak like someone sucked all her energy out; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 46-years-old, administered in Arm Left on 01Apr2021 13:30 (Lot Number: ER8734) as single dose for COVID-19 immunization. Medical history included ongoing High Blood Pressure, hyperthyroidism from 28Mar2021 and ongoing, allergy to Cheese and penicillin. Everyone in her family has done fine with the vaccine except her. Concomitant medications included thiamazole (METHIMAZOLE) taken for hyperthyroidism from 28Mar2021 and ongoing; atenolol, chlortalidone (ATENOLOL AND CHLORTHALIDONE) taken for hypertension from an unspecified start date and ongoing; amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing. On Thursday 01Apr2021, the patient had her first shot and she stayed for 30 minutes. After she was allowed to leave, she passed out and went completely unconscious and she was rushed to the ER. She sat for the 30 minutes, then got to her car and it took 10 minutes to get to department store and with in 7 minutes of being at department store she started feeling nauseous then came the fatigue and she felt nauseous and felt like she was going to pass out so she sat down, she didn't know what was going on. It started with her feeling nauseous and then she started to feel weak like someone sucked all her energy out. She states in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills. The EMS took her to the ER. The adverse events occurred on 01Apr2021 14:30 (as reported). The ER let her go home Thursday night. They gave her an IV and did lab work and the lab work came back fine. It was a combination of her meds and the vaccine or it was just the vaccine. Her primary doctor said it was the vaccine. She is scheduled 22Apr2021 for her second one and she is calling to see if there is any advice or anything she needed to do for the second shot. Her doctor told her that when she takes it, she needs to be close to the ER so a doctor can monitor her. Treatment for events included IV fluids to help from being dehydrated and throwing up, Emergency Room, possibly Benadryl. The events required a visit to Emergency Room on 01Apr2021 and to the Physician Office on 05Apr2021. The outcome of the events passed out and went completely unconscious and felt weak like someone sucked all her energy out was recovered on 02Apr2021 while for the rest of the events was recovered on 01Apr2021. The events were considered as serious (medically significant). No Prior Vaccinations (within 4 weeks), no adverse events following prior vaccinations. Information on Lot/Batch number was available. Additional information has been requested.
46 2021-04-20 discomfort, bell's palsy, facial paralysis Patient developed pain in R preauricular area on the day following vaccine. Discomfort continued and... Read more
Patient developed pain in R preauricular area on the day following vaccine. Discomfort continued and on the following day patient noted mild droop of R side of face, decreased blinking of R eyelid. Diagnosed with Bell's Palsy, treated with prednisone 60mg for 5 days, then 40mg for 5 days. Patient undergoing ongoing treatment.
46 2021-04-20 difficulty speaking, pain in extremity 1st dose- arm soreness, headache, horse throat 2nd dose- arm soreness, headache, fatigue, nauseous,... Read more
1st dose- arm soreness, headache, horse throat 2nd dose- arm soreness, headache, fatigue, nauseous, muscle ache, chills, swollen under arm lymph node (L) Mass on left thyroid lobe
46 2021-04-20 feeling hot VS 147/90, HR 82 bpm, 98% RA, heart/lungs clear, rhythm regular, no stridor, no hives. Around 14 min... Read more
VS 147/90, HR 82 bpm, 98% RA, heart/lungs clear, rhythm regular, no stridor, no hives. Around 14 minutes after injection started to have sensation of warmth in her abdomen which she says moved down, chest tightness + dizinness, no SOB, hives or facial/lip/tongue, swelling nor sensation of the throat closing Allergies: tetanus shot (warmth, hives, sensation of throat swelling), benadryl (felt like coming out of her skin), sertraline (palpitation) PMHs anxiety, ADHD, HTN, aFIB, KIDNEY STONES, No meds were given Symptoms resolved and pt stated she thinks its from her allergy
46 2021-04-20 numbness, burning sensation, burning sensation, numbness Dizzy , felt nauseated, numbness in right arm, burning .Stated "the same thing happened last time" o... Read more
Dizzy , felt nauseated, numbness in right arm, burning .Stated "the same thing happened last time" on 3/27/2021. BP 118/78 HR 78 BP 140/85 HR 62- 30 mins later Remained in the observation area for 30 mins
46 2021-04-20 tingling After around 8 min after shot, started to get severe tingling and tightness in left side of jaw, the... Read more
After around 8 min after shot, started to get severe tingling and tightness in left side of jaw, then tightness in whole jaw, then throat felt like it was swelling, then had minor difficulty breathing and chest got very tight. Then got lightheaded/dizzy after walking to report symptoms to nurse. Was given 50 mg liquid benadryl and two epi pens after breathing continued to become more difficult and chest was very tight/cramping. EMTs took me to ER by ambulance, was monitored for about 4 hours and released. Continued having very tight/painful chest and swollen throat each time benadryl wore off and had to go back to ER following day. All tests were clear and was released. Severe allergic reaction but not anaphylaxis.
46 2021-04-20 speech disorder I went and got my shot. Once the shot was administered, I waited in the room for 15 mins before leav... Read more
I went and got my shot. Once the shot was administered, I waited in the room for 15 mins before leaving. On my way home from getting the shot, I felt tired and I drunk some water. One hour later my tiredness began to increase. around 4:30pm, I laid down to take a nap. My son woke me up at 5:30pm for softball practice and my head felt like I was on a roller coaster so I was sitting at practice. I had pains in my stomach and felt sick and wanted to vomit. Ate a salad from restaurant around 7:30 pm and was talking to my husband on the phone when my speech started to mess up. My husband called the nurse hotline and explain everything that was going on but ended the phone call because he's stationed in Florida and had our son to call the nurse hotline. Our son called the nurse?s line again and explained the events that were happening. The paramedics came in and got me. I was hospitalized for two days. I did a follow up with my PCP on Monday, April 19, 2021 and I have to see a Neurologist and get another MRI. doctor said that I cannot be alone and cannot drive.
46 2021-04-21 flushing On 4/20 at 1015 Patient, a 46yo female born 05/13/1974, was sitting with the RN for a 2nd dose Pfize... Read more
On 4/20 at 1015 Patient, a 46yo female born 05/13/1974, was sitting with the RN for a 2nd dose Pfizer. She reported to the RN that 2 weeks following her 1st dose Pfizer (Received: 3/30/2021, LOT # ER8737 Exp: 08/30/2021) she developed a rash at the site of her injection. Client showed the RN a photo of the rash on her arm. The photo revealed a raised erythematous area surrounding the injection site. Client states the rash was warm to the touch and accompanying symptoms included flushing and shortness of breath. Client states the symptoms lasted a few days. She contacted her PCP who made a follow up appointment with the client for 4/22/2021. Client's arm on 4/20/21 revealed an indented, discolored scar at site of injection. She denied any signs and symptoms immediately following 1st dose vaccine and states the symptoms did not develop until 2 weeks status post first vaccine.
46 2021-04-21 numbness, tingling Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: numbness under tongue l... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: numbness under tongue left side, jaw left side, forhead left side novacaine like feeeling-Medium, Additional Details: left side under tongue numb, left jaw numb, forhead numb decreased with administration of benadryl butr did not go away 1.5 hors post shot. pt states feels like when she gets novacaine at dentist..tingly as well\r\n
46 2021-04-21 numbness, throat numbness Pt, was sitting in post observation post 1st dose of Pfizer vaccine. Pt has no hx of anaphylaxis. Pt... Read more
Pt, was sitting in post observation post 1st dose of Pfizer vaccine. Pt has no hx of anaphylaxis. Pt began to feel numbness in left arm radiating up to left side of throat. Pt a bit lightheaded. Pt given juice and water and felt better. Numbness resolved after juice and water. Pt call. Pt finished appropriate monitoring time and ambulated out of facility with steady gait in no distress.
46 2021-04-21 numbness and pain in extremities, tingling Peripheral neuropathy presenting as a mild tingling in ball of big toe on each foot initially, gradu... Read more
Peripheral neuropathy presenting as a mild tingling in ball of big toe on each foot initially, gradually progressing over 3 days to include bottoms of both feet and traveling up calves to knees. It gets worse at night. Also started in fingertips on hands at the same time, gradually progressing over 3 days to include palms and traveling up to elbows. On day 5 tingling and 'fuzziness' is less noticeable in arms and hands. No change in legs and feet. It does make it hard to fall asleep and wakes me up Somme nights. During the day bottoms of both feet are constantly 'fuzzy' while other areas diminish. There is also a burning ring on scalp at crown on head that follows similar pattern.
46 2021-04-21 pain in extremity Report left thumb pain started with 15 minutes of receiving the vaccine and resolved 15 minutes afte... Read more
Report left thumb pain started with 15 minutes of receiving the vaccine and resolved 15 minutes after receiving the vaccine. Report today 4/22/21 constant pain of the left thumb, report pain with movement, and mild swelling. Treatment: Tylenol with no improvement. Outcome: Does not interfere with ADLs, will continue to monitor and follow-up with primary doctor if worsens
46 2021-04-21 pain in extremity fatigue and sudden throbbing pain radiating from left side of neck to shoulder, down to arm and back... Read more
fatigue and sudden throbbing pain radiating from left side of neck to shoulder, down to arm and back area that progressed to opposite side of vaccination site.
46 2021-04-21 pain in extremity Adverse Event: Vomit, Stool, Chills, Fatigue, Sweat, Headache, Soreness (Left Arm, Left Leg) Treat... Read more
Adverse Event: Vomit, Stool, Chills, Fatigue, Sweat, Headache, Soreness (Left Arm, Left Leg) Treatment: Tylenol, Cold Water (to Drink), Layers of Clothes/Blankets & Heat, Sleep, Disrobed/Cool Fan Time Course: Fatigue & Soreness- 24 hours Post Vaccine Adverse Event - 48 hours Post Event (8a-10a) Fine after Treatment (3:30p) - No symptoms
46 2021-04-21 pain in extremity Very sore, aching arm. So bad it woke me up the first night. Next day, all over body aches, letharg... Read more
Very sore, aching arm. So bad it woke me up the first night. Next day, all over body aches, lethargy, some nausea. Fever of 101. Stayed home, went to bed. Day three, left arm still aches, I'm still tired.
46 2021-04-21 tingling, numbness, discomfort I received my first dose of the Pfzer vaccine on 4/14/2021 I was asked to wait in a waiting area fo... Read more
I received my first dose of the Pfzer vaccine on 4/14/2021 I was asked to wait in a waiting area for 15 minutes to be monitored. Within 5 minutes of receiving the vaccine. I had a strong metal taste in my mouth and felt like my lips were swelling. I alerted the medical staff team and they brought me back into a room to be monitored. My mouth was numb. (felt as if I was given numbing shots at a dental facility) A nurse gave me a zyrtec and pepsid. They monitored my for 30 minutes. Numbness still was strong and present but I showed no signs of respiratory distress and they allowed me to go home. I was told a staff would be calling on me to check on me later that day. (this never occurred) About 30 minutes later on my way home, the numbness I was experiencing in my mouth now was in my Right Arm starting at my elbow and was spreading upward toward my shoulder, neck and right side of my face. I called the clinic back and was advised to go immediately to the ER. I went to Hospital in. I was checked out by a physician, given a neurological assessment, given 5 steroid pills and also given a eye exam. The numbness was intensifying and I felt extreme pressure accompanied by blurred vision in my right eye. My Blood pressure was also extremely elevated. I was left in a exam room for 4 1/2 hours. I had no signs of sensation returning to the numb areas. ER Doctor consulted with the Neurologist and then advised me to follow up with my primary care for potential Neurologist referral for a MRI. He stated that the medical staff was slammed and that I could not have a MRI at that time. He felt that I wasn't critical and that a MRI could be scheduled at a later time. I followed up with my Primary Care Physician. She did blood work, another eye exam and referred me to see a Neurologist, Ophthalmologist and allergist. I have made the necessary appointments and am awaiting further testing for ongoing issues. (MRI, VEP, & EMG) Numbness lasted two days, followed by tingling for another day. I continue to struggle with blurred vision in my right eye, severe headaches and pain in my shoulder and neck area.
46 2021-04-21 tingling Patient stated that she was tingly in her right arm 15 minutes after administration of vaccine. This... Read more
Patient stated that she was tingly in her right arm 15 minutes after administration of vaccine. This progressed to itching all over. Patient was very anxious stating that this occurred with the varicella vaccine as well and that "something always happens to me." Patient reported no allergies and no difficulty breathing, dizziness, tingling of the mouth or face, or numbness. 50mg of Benadryl was administered and patient was monitored for an additional 30 minutes. Patient consumed snacks and drink and felt ok to leave at 0935. Patient was educated by RN about serious adverse reactions to monitor for and to call 911 immediately if patient experienced these.
46 2021-04-21 tingling mild intermittent tingling throughout body lasting for more than 24 hours after vaccine. More consi... Read more
mild intermittent tingling throughout body lasting for more than 24 hours after vaccine. More consistent tingling in mouth/throat began approximately 7 hours after injection and continued for 3 hours. Throat began to close up and I took a Benadryl which stopped the tingling in my throat and I was able to breathe better. I repeated a second dose of Benadryl before bed that night to ensure that the event did not repeat itself. Tingling and swelling in throat and mouth never returned , Mild intermittent tingling in rest of body continued throughout day two post injection but it tolerable and did not require medication. Fever (101), body aches, chills and muscle pain began 12 hours after injection and persisted for approximately 18 hours.
46 2021-04-22 burning sensation Felt like the vaccine was burning through my veins in both of my arms....woke up in the middle of th... Read more
Felt like the vaccine was burning through my veins in both of my arms....woke up in the middle of the night with it and could not get comfortable due to pain and due to burning sensation.
46 2021-04-22 burning sensation Approximately 4-5 hours post vaccination, client states she noticed redness over entire face and bil... Read more
Approximately 4-5 hours post vaccination, client states she noticed redness over entire face and bilateral upper arms. Client states area of redness had burning sensation with touch. Client states similar to sunburn. Client states resolved approximately 24 hours after she first noticed the redness.
46 2021-04-22 numbness, pain in extremity, feeling of body temperature change 3/23- nothing 3/23- slight leg ache for 20 minutes, fever at 100.8 with 1K MG Tylenol, sore throat, ... Read more
3/23- nothing 3/23- slight leg ache for 20 minutes, fever at 100.8 with 1K MG Tylenol, sore throat, hot and cold but no chills (called doctor for Zithromax) 3/24- fever lessened, arm began hurting (not at deltoid muscle where shot was administered), arm lost mobility in the afternoon (could not lift above my shoulder), sneezing, coughing, runny nose 3/25- could not type in the morning, able to type later in day, 3/28- Covid tested negative 3/29- Advised doctor's Clinical Assistant I didn't remember 3/24-3/25 too well and my arm pain was still present Month of April: Resolved: Covid type symptoms loss of arm mobility Armpit pain Shoulder blade pain Present: Breast implant pain on left side (occasional) Left hand and finger numbness All symptoms on left side of body except new back pain
46 2021-04-22 migraine Patient experienced sever migraine headache 10 minutes after vaccination which caused her to have sh... Read more
Patient experienced sever migraine headache 10 minutes after vaccination which caused her to have shortness of breath for few minutes. EMT arrived at the scene and patient refused to go hospital once she was feeling better after 20 minutes. Patient went home by herself and was feeling better.
46 2021-04-22 migraine Dizziness, Vertigo, chronic Migraine
46 2021-04-22 muscle spasms First 48 hours included muscle aches and cramping that cleared up as expected. As those symptoms c... Read more
First 48 hours included muscle aches and cramping that cleared up as expected. As those symptoms cleared, full body rash began on the evening of April 17 and is still worsening on April 23. Raised, red, and itchy small bumps all over body (including feet, ankles, legs, thighs, stomach, back, shoulders, arms). Some bumps open and weeping. Limited sleep for four consecutive nights even with oral Benadryl. Does not show much signs of improvement on Day 6.
46 2021-04-22 pain in extremity, feeling hot Within 5 minutes after receiving injection in the arm, I felt a heat wave coming over my body (start... Read more
Within 5 minutes after receiving injection in the arm, I felt a heat wave coming over my body (started in my legs) & instant headache and sore arm. After the 15 minute duration, I left the building and sat in my car for about 30 minutes having the coldest setting of the A/C blowing in my face. I also felt my tongue swell up and felt a bit dizzy. Spoke to my family, informed them about my status. When I felt well enough to leave (within 45), I went home. Symptoms did not come back. Arm remained sore for three days.
46 2021-04-22 pain in extremity A large lump near my collar bone. The lump was tender to the touch. Also, in addition to arm sorene... Read more
A large lump near my collar bone. The lump was tender to the touch. Also, in addition to arm soreness, I was unable to turn my neck to the left. Felt like a pinched nerve.
46 2021-04-22 tenderness Swelling and pain at the base of left side of the neck. Very tender to the touch. Swelling diminis... Read more
Swelling and pain at the base of left side of the neck. Very tender to the touch. Swelling diminishing on day 3 but still very sore.
46 2021-04-22 tenderness Swollen lymph nodes in armpit in arm that received shot. Very sore to touch and move. Swelling an... Read more
Swollen lymph nodes in armpit in arm that received shot. Very sore to touch and move. Swelling and tenderness went from exterior (back) of armpit to interior (front) of armpit near the breast.
46 2021-04-22 tremor Received the shot just before 11am. 14 hours later, at 1am, I woke up with horrific projectile vomit... Read more
Received the shot just before 11am. 14 hours later, at 1am, I woke up with horrific projectile vomiting, the kind that splashes back out of the toilet onto myself and the bathroom. This lasted for approximately 4 hours all while shivering/shaking/freezing and had a fever. I would throw up, shiver for about 10 minutes and then do it all over again non-stop for 4 hours. Finally fell asleep and woke up with a fever over 101 that lasted all day with body aches.
46 2021-04-23 pain in extremity Approximately 10 hours after the injection, my left arm started feeling sore. I went to bed and woke... Read more
Approximately 10 hours after the injection, my left arm started feeling sore. I went to bed and woke up around 3:45AM with a headache, muscle aches, and my arm was at a level 7/10 for pain. I took Tylenol which helped some.
46 2021-04-23 tingling, numbness Short term reaction to second vaccine caused flu-like symptoms. Severe headache, body aches, chills,... Read more
Short term reaction to second vaccine caused flu-like symptoms. Severe headache, body aches, chills, starting about 12 hours post vaccination and continuing for about 36 hours. Chills add it hard to get warm, and felt like I had little circulation to extremities. I noticed that my hands and feet also fell asleep more easily and I continued to get pins and needles sensations after sitting or lying still with my weight on them. Starting 10 days later, I began to experience areas of complete numbness on the tops and sides of my feet, much more severe on the right side. It feels like my skin has been injected with anesthetic, and it does not go away with movement or stimulation. It seems to be spreading up over my ankle bone and up the back of my leg. I also have twinges and a tingling sensation running up the back of my right leg into my hip on the right side.
46 2021-04-24 weakness fainted/fainting; felt weak and dizzy/weakness; felt weak and dizzy/dizziness; blood pressure was ve... Read more
fainted/fainting; felt weak and dizzy/weakness; felt weak and dizzy/dizziness; blood pressure was very high; fast heartbeat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733), via an unspecified route of administration, administered in arm left on 27Mar2021 18:15 (at the age of 46-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no covid prior vaccination. No other medication in two weeks. No other vaccine in four weeks. On 27Mar2021 18:45, the patient felt weak and dizzy a few minutes after getting the vaccine and then she fainted. The paramedics took her to the ambulance to check her vitals. EKG, blood sugar and blood oxygen was good, but her blood pressure was very high. Clinical course details was reported as she received the first dose of the Pfizer COVID vaccine on 27Mar2021 and she experienced fainting, dizziness, weakness and a fast heartbeat. The patient would like to know if fainting was considered an allergic reaction. The patient would like to know if she should receive the second dose of the vaccine. She received the 1st dose last 27Mar2021 and 2nd dose will be on 17Apr2021. The reported events resulted in doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the events. The outcome of the events was recovering. The patient did not covid tested post vaccination.
46 2021-04-24 pain in extremity nausea (bad); exhaustion/fatigue (bad); pain in arm; headache; Diarrhea; body aches; This is a spont... Read more
nausea (bad); exhaustion/fatigue (bad); pain in arm; headache; Diarrhea; body aches; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 05Apr2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's and Celiac disease, known allergies: Gluten, dairy and eggs, all from an unknown date and unknown if ongoing. Concomitant medications included citalopram and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop dates were not reported. The patient experienced nausea (bad), exhaustion/fatigue (bad), pain in arm, headache, diarrhea and body aches on 05Apr2021 at 19:30. There was no treatment received for the events. The outcome of the events was recovered on an unspecified date.
46 2021-04-24 pain in extremity severe pain in my right leg from mid thigh to lower ankle- feels like someone is crushing the bones ... Read more
severe pain in my right leg from mid thigh to lower ankle- feels like someone is crushing the bones in my leg/comes on instantly with various movements; severe pain in my right leg from mid thigh to lower ankle- feels like someone is crushing the bones in my leg/comes on instantly with various movements; severe pain in my right leg from mid thigh to lower ankle- feels like someone is crushing the bones in my leg/comes on instantly with various movements; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 04Apr2021 15:00 (Lot Number: ER8730) as a single dose for covid-19 immunisation. Medical history included major depressive disorder and (CVID) common variable immunodeficiency. The patient has no known allergies. The patient was not diagnosed with Covid-19 prior to vaccinationThe patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) on 14Mar2021 at 15:00 (lot number: EN6202) in the left arm at vaccination age 46-year-old for covid-19 immunization. Concomitant medications included fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), valacyclovir [valaciclovir] (VALACYCLOVIR), cyanocobalamin (B-12), and gam; all indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient received the vaccine in a pharmacy or drug store. It was reported that 6 days later (05Apr2021 10:30 AM), she had severe pain in her right leg from mid-thigh to lower ankle. She feels like someone is crushing the bones in her leg (comes on instantly with various movements), has 9-10 on a pain scale of 0-10 and 98% of time can no longer bend her leg when sitting on ground or pain is unbearable. The adverse event resulted in emergency room/department or urgent care for the disability or permanent damage. The events received treatment which included wrapped knee and was referred to an orthopedic doctor. The patient has not been tested post vaccination. The outcome of the events was not recovered.
46 2021-04-24 tingling Felt cold going up shoulder 10 minutes after receiving vaccine. Tingling all the way down arm to fi... Read more
Felt cold going up shoulder 10 minutes after receiving vaccine. Tingling all the way down arm to fingertips 3-4 hours after vaccine. Fatigue for at least 3 days. Pain in center of chest ongoing for 3 days. Feels like I've just finished a workout in terms of heart beating hard - intermittently for 3 days. I hope this goes away soon.
46 2021-04-24 tingling aches keep coming and going, on and off; massive headache; weird pulling feeling on both of her legs... Read more
aches keep coming and going, on and off; massive headache; weird pulling feeling on both of her legs/like a light switch; burning sensation in her nose; lips swelled up; weird feeling on the edges of her tongue; she felt off; tongue swelled up; blisters on the tip of her tongue; hasn't been feeling right; face was itchy/ skin was itchy; inner ears were itchy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 31Mar2021 at 09:30 (46-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing MTHFR (genetic thing called MTHFR. She has trouble digesting synthetic vitamins and folic acid), IVF, COVID-19 virus in Mar2020. Patient had no known or documented allergies. Concomitant medications included monascus purpureus (RED YEAST RICE) and multivitamin (unspecified). The patient previously received famotidine from an unspecified date to 2021 (stopped several weeks before). Patient reported after receiving the COVID-19 vaccine her tongue swelled up and she hasn't been feeling right since she got the vaccine. When asking caller to clarify what she meant when she reported "not feeling right" she reports she didn't feel right immediately after getting the COVID-19 vaccine. On day 1 of getting the COVID 19 vaccine, 31Mar2021, her face was itchy but her face wasn't red, she had no rash or hives; her inner ears were itchy and her skin was itchy. She got the COVID-19 vaccine at 9:30 and an hour or two later her tongue swelled up. She took diphenhydramine hydrochloride (BENADRYL). She also had blisters on the tip of her tongue. The next day, 01Apr2021, the swelling had subsided but she still had a weird feeling on the edges of her tongue. It felt weird. Her tongue was not red or swollen at that time. On 01Apr2021 she felt off. Then on day 3, 02Apr2021 she had a burning sensation in her nose and her lips swelled up. On Saturday, 03Apr2021 she went to(visit to physician office) because she had a weird pulling feeling on both of her legs. The pulling feeling on her legs was like a light switch. The feeling was going on all day 03Apr2021. Then the next day, Sunday 04Apr2021, the pulling sensation on her legs was gone but she did wake up with a massive headache. She had the headache since 04Apr2021 morning. She's been having these symptoms since she received the COVID-19 vaccine and she can't attribute the symptoms to anything else. She's also had aches throughout this whole process and the aches keep coming and going, on and off. She still feels a weird thing on her tongue but she can't see anything on her tongue. She'd be in a better place except for her headache. She never had a fever. She was expecting to have flu like symptoms after getting the COVID-19 vaccine. She didn't have any of those symptoms. When probing medical history and concomitant medications she reports she's been to an allergist and she has no documented allergies. Her doctors are aware of the symptoms she's been having since she received the COVID-19 vaccine. There is something, she does know she has a genetic thing called MTHFR. She has trouble digesting synthetic vitamins and folic acid. She knows she has this genetic thing because she went through IVF to have her children and the MTHFR came up on one of the blood panels. She can't break down certain vitamins so she has to avoid anything that has folic acid in it and she can't take vitamins with folic acid in it. She reports she took no medications on the same day that she received her COVID-19 vaccine. She reports she used to take Famotidine but stopped taking it several weeks ago. She did go to the physician's office because she got really nervous when she had the pulling sensation on her legs. The physician's office had no explanation and nothing to really report. The physician's office told her to contact the CDC. She is asking if she's had an allergic reaction and should she even consider getting the second COVID-19 vaccine. Therapeutic measures were taken as a result of the events and included diphenhydramine hydrochloride. The outcome of massive headache was not recovered; tongue swelled up was recovered on 01Apr2021; weird pulling feeling on both of her legs/like a light switch was recovered on 04Apr2021; outcome of other events was recovering. Information on the lot/batch number has been requested.
46 2021-04-25 weakness, pain in extremity After I received the vaccine my arm hurt and I felt run down for 2 days. But now 8 days later my arm... Read more
After I received the vaccine my arm hurt and I felt run down for 2 days. But now 8 days later my arm hurts again like I just got vaccinated and I feel run down. Not a huge deal, but just want others to know to expect something like this.
46 2021-04-25 weakness Severe radiating/pulsing pain in both knee joints. The pain woke me from sleep, and repositioning di... Read more
Severe radiating/pulsing pain in both knee joints. The pain woke me from sleep, and repositioning did not provide any relief. Weakness and tightness when attempting to stand/walk. Unable to stand from a seated position without using hands to pull up. Episode lasted about 5 hours, pain has gone from severe to mild as of the time of writing this.
46 2021-04-25 cold sweat, muscle spasms Period started about 2 weeks early which I expected after I experienced that same thing with the fir... Read more
Period started about 2 weeks early which I expected after I experienced that same thing with the first shot. After second I had bad body cramps. Then Saturday started off feeling like a kidney infection. By Sunday I was feeling worse but quickly progressed to severe cramps that felt like with labor and chest pain. Felt like a heart attack with lightheaded ness, cold sweats and thought I was going to faint.
46 2021-04-25 feeling hot Client reported to another staff member of feeling hot and throat tightness approximately 10 minuets... Read more
Client reported to another staff member of feeling hot and throat tightness approximately 10 minuets after receiving Pfizer vaccine. Client in the ladies room with her preschool age son. Client told writer she felt "hot" and had to get out of the clinic for "some air." When writer encountered client she denied difficulty breathing and went outside and sat on a bench with her husband. B/P 120/80. Writer discharged from clinic in the company of her husband. Writer instructed client to activate emergency response system for difficulty breathing. Client verbalized understanding of teaching.
46 2021-04-25 numbness, tingling 48 hours after the vaccine was administered I had itching on my hands, face and feet. tingling numbn... Read more
48 hours after the vaccine was administered I had itching on my hands, face and feet. tingling numbness in the hands. a lot of itching in parts of the body.
46 2021-04-25 muscle spasms 2 days after 2nd dose, experienced sever, intense cramps, and profuse menstrual bleeding. only one w... Read more
2 days after 2nd dose, experienced sever, intense cramps, and profuse menstrual bleeding. only one week after my normal cycle had stopped. day 1 was unusually heavy, day 2 was extremely heavy the whole day and night. days 3 and 4 and 5 were heavy, but not as painful. the bleeding seems to have finally subsided now, day 9. my normal cycle usually only lasts a few days and is very light, rarely painful or with cramping.
46 2021-04-25 pain in extremity Light headed and left hand pain. VS 92 147/80 100%
46 2021-04-25 pain in extremity Lightheaded for 48 hours. Headache, sore arm, sore neck for two weeks. Dizziness and brain fog for... Read more
Lightheaded for 48 hours. Headache, sore arm, sore neck for two weeks. Dizziness and brain fog for 2 1/2 weeks.
46 2021-04-25 tingling, flushing Pt called back 2-3 hours after leaving from vaccine to report that her lips were tingling and her ch... Read more
Pt called back 2-3 hours after leaving from vaccine to report that her lips were tingling and her chin was tingling, and she had some flushing. She stated that she had been monitoring her vitals and that she had no trouble breathing or swelling. Pt stated that she took a Benadryl to treat it. I told pt that if she was having any difficulty breathing she should call 911 or go to the hospital immediately. She stated that she thought she was past the anaphylactic reaction point, and she did not want to go to the doctor. I informed her that if she begins to have any trouble breathing to call 911 as soon as possible.
46 2021-04-25 tingling, numbness Both Vaccines were given to me on my left arm. I am feeling numbness and tingling on my left arm and... Read more
Both Vaccines were given to me on my left arm. I am feeling numbness and tingling on my left arm and left side of my face. I have lost strength on my left arm. I cannot lift my left arm past my shoulder and I do not have strength to hold on to anything on my left arm.
46 2021-04-26 breast pain, pain in extremity The day after receiving the first vaccine, my fingers and toes on both sides became swollen and pain... Read more
The day after receiving the first vaccine, my fingers and toes on both sides became swollen and painful. Even now, four weeks after the first vaccine, my fingers are two ring sizes swollen, and my toes are swollen. There is constant pain in the joints in my fingers and toes. Also, I developed a sharp, intermittent shooting pain behind my right breast one day after receiving my second Pfizer vaccine on April 19.
46 2021-04-26 feeling hot Around 4 hours after the vaccine, I got minor head pressure and a little nausea. Around 12 hours aft... Read more
Around 4 hours after the vaccine, I got minor head pressure and a little nausea. Around 12 hours after the vaccine, I woke up with head pain that escalated very quickly. It was some of the worst pain I have ever had next to childbirth. My entire head, temples, forehead, and back of neck had excruciating pain and felt like the skin was on fire. It wasn?t hot to touch but to me it felt like my skin was burning only from my neck up. I had a fever of 101. I used ice packs directly to my head and neck and Tylenol. Neither took the pain away. This all lasted 15 hours. The fever broke and the pain went away. The next morning, about 40 hours after the vaccine, my entire neck and spine wore sore and I was achy. This lasted the whole day. I have had periods through the next couple days where I have brief moments of feeling hot. I also developed 2 small bruises (one on each leg), but neither are painful. Today I have had mouth sores/irritation but by evening that went away.
46 2021-04-26 feeling of body temperature change, tremor Woke at 3:30am shaking, kept switching from freezing to sweating, achey, fidgety, nauseous, unable t... Read more
Woke at 3:30am shaking, kept switching from freezing to sweating, achey, fidgety, nauseous, unable to sleep, headache, temperature over 102.
46 2021-04-26 pain in extremity, feeling hot On day 9 after my second vaccination woke up feeling itchy, inflamed with severe joint pain in knuc... Read more
On day 9 after my second vaccination woke up feeling itchy, inflamed with severe joint pain in knuckles, hips, and feet and a hot scalp headache, extreme fatigue. On Saturday had the same pain/inflammation symptoms and began running a low grade fever (99.4-99.6) that was not responsive to ibuprofen. Ran a fever also on Sunday, 99.6, again not responsive to ibuprofen. Began taking Claritin in case this was a serum sickness like reaction on Monday and that helped immensely, finally the ibuprofen was able to work and the fever went down. Today, Tuesday, I am still itchy all over, fatigued and with some pain but not as bad. I also took Claritin and ibuprofen on waking. While I have chronic health issues these reactions are totally new for me. I had four weeks of intense, relentless inflammation, headaches and extreme joint pain (my joints visibly red for weeks) (no fever after my first dose of the vaccine) but my doctors never mentioned SSLR. With the second dose I actually felt better for over a week, but then it all came back, was much worse and the delay was confusing. It was almost impossible to find information about delayed non-local reactions. I am reporting it because other people need to know that SSLRs are possible with this vaccine and can be debilitating. Please let people know!
46 2021-04-26 pain in extremity Fever 102; very fatigued; Headache; left arm pain; increased nasal congestion; This is a spontaneous... Read more
Fever 102; very fatigued; Headache; left arm pain; increased nasal congestion; This is a spontaneous report from a contactable consumer (Patient herself). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Formulation: Solution for injection via an unspecified route of administration in the left arm on 17Feb2021 09:00 (Batch/Lot Number: EN 5318) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM; famotidine (PEPCID [FAMOTIDINE]); beclometasone dipropionate (QNASL); magnesium (MG [MAGNESIUM]); amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos (JUICE PLUS); ergocalciferol (VIT D). The patient previously took BNT162b2 for covid-19 immunisation, anaprox and experienced drug hypersensitivity. On 17Feb2021 17:00 patient experienced fever 102, very fatigued, headache, left arm pain, increased nasal congestion. Patient perform lab tests which included body temperature: 102. The patient not tested for COVID-19 prior to vaccination and post vaccination. The patient did not receive treatment. The outcome of the events was not recovered.
46 2021-04-26 pain in extremity The next day after the 2nd dose, around 4pm CST, I believe I may have experienced a cardiac event. O... Read more
The next day after the 2nd dose, around 4pm CST, I believe I may have experienced a cardiac event. Over the course of an hour, chest and back pains along with shortness of breath almost crippled me. I don?t after my PCP who told me to go directly to the ER. I was it able to go because I could not afford the costs. The pains were like labor contractions and each time hurt more. I recently had a physical, don?t have any underlying health conditions and don?t take any medications for chronic conditions. The 2nd day, I experience left pain in my neck, and leg along with reduced chest pains
46 2021-04-26 pain in extremity Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the ho... Read more
Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:00 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later, the patient went to the hospital and was diagnosed with a blood clot/DVT. AE resulted in: [Emergency room/department or urgent care]. The patient received treatment for the events: Vitals taken, blood work, prescribed blood thinner. The patient underwent lab tests and procedures which included blood test: unknown result on an unspecified date ae treatment= Vitals taken, blood work , investigation: blood clot/dvt on 08Apr2021 3 days later I went to the hospital and was diagnosed with a blood clot/DVT, investigation: unknown result on an unspecified date ae treatment= Vitals taken, blood work. The outcome of the event was recovering. The patient does not have COVID prior vaccination, and was not COVID tested post vaccination. The patient has no known allergies.
46 2021-04-26 tremor, speech disorder, muscle twitching, involuntary muscle movements At around 11:45 pm on 4/26/2017, I experienced chills and uncontrollable involuntary shaking until 1... Read more
At around 11:45 pm on 4/26/2017, I experienced chills and uncontrollable involuntary shaking until 12:05/12:10 am. Several parts of my body started twitching like my lower back, right hand, arms, shoulders and it was impossible to stay lying down. I noticed my jaw tightening and my speech a little constricted. The shaking increased with time and then stopped abruptly and completely.
46 2021-04-27 weakness Fever of 101.0, severe chills, severe body aches (joint and muscle pains including pain in wrists, h... Read more
Fever of 101.0, severe chills, severe body aches (joint and muscle pains including pain in wrists, hands, neck, arms, shoulders, back and legs), severe headache, for 48+ hours, loss of appetite and even pain behind my eyes. Administered Advil and Tylenol on a rotation schedule every 4 hours (taking the medications 1 hour a part from each other) to no avail for more than the first 24 hours. Arm pain from injection site lasted 4-5 days. It took more than 48 hours for the fever to break and for severe muscle and joint pains to calm down. Felt fatigued and weak for another 2 days following.
46 2021-04-27 depressed level of consciousness Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; ... Read more
Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; This is a spontaneous report from a contactable consumer via Program. The 46-years-old female consumer (patient) received BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown,) on 19Mar2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. The other medication included XELJANZ XR TAB 11MG since 28Jul2020. Patient reported that she had an anaphylactic reaction to her first Pfizer COVID-19 vaccine on 19Mar2021. Since this reaction she has had a lot of brain fog and diarrhea, that was not happening before the reaction. Patient also said that her hip pain has gotten progressively worse and affecting her ability to dress herself. Further patient explained she will miss 2 doses of Xeljanz before she receives the medication on 15Apr2021. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-04-27 pain in extremity Left arm pain to the point of unable to use it
46 2021-04-27 pain in extremity Fever, chills, arm soreness, muscle aches, and fatigue lasting three (3) days.
46 2021-04-28 inability to speak, migraine, speech disorder Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensi... Read more
Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensitivity to lights and sounds; inability to speak; neck stiffness; vertigo; confusion; altered personality; hallucinations; memory loss; difficulty with word retrieval; migraines; recurring headaches; loss of appetite; difficulty concentrating; clumsiness; off balance; reduced speed of thought; This is a spontaneous report from a contactable consumer, reporting for herself. A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 14:30 at a single dose for covid-19 immunisation. The patient received the bnt162b2 in the hospital. The medical history was not reported. There were no allergies. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN) taken for an unspecified indication, start and stop date were not reported. On 25Mar2021 at 16:00, the patient experienced drowsiness, sensitivity to lights and sounds, inability to speak, neck stiffness, uncharacteristic behavior/ not aware of behavior, confusion, altered personality, hallucinations, memory loss, extreme sleepiness, difficulty with word retrieval, migraines and recurring headaches, loss of appetite, difficulty concentrating, clumsiness and off balance, reduced speed of thought, and vertigo, which were serious for disability. The events required emergency room and physician office visits. Therapeutic measures were taken as a result of the events and included treatment with fluids and acetaminophen (TYLENOL). There was no covid prior to or post vaccination with bnt162b2. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
46 2021-04-28 breast pain I am an extremely regular person when it comes to my period. It is 28 days, down to the hour. The pe... Read more
I am an extremely regular person when it comes to my period. It is 28 days, down to the hour. The period after my first dose was three days late. It was heavier than normal, and I had some severe body aches. When I got my second dose, I experienced fatigue and body aches for a few days after. For about 10 days before my period I experienced incredibly achey breasts (this usually happens just 1-2 days before, and medium ache). Just got my period this morning, 2 days early. My whole body is achy, and the flow is really heavy.
46 2021-04-28 burning sensation rash, swollen hand, burning sensation on hand (not injection site)
46 2021-04-28 discomfort Initial reaction was noted on 4/22 she felt tired. 4/22 high heart rate (95) and BP was elevated (1... Read more
Initial reaction was noted on 4/22 she felt tired. 4/22 high heart rate (95) and BP was elevated (150/70 which is high for her). 4/24 in evening, woke up with an uncomfortable feeling. Felt some chest pain. Then she felt better for a day on 4/24. Then tired again 4/25. 4/28 she developed redness in her face. She feels nausea. She feels drowsy. Has heaviness in the chest when lying down. She has trouble breathing, when she has to walk up the hill.. Body aches worse after vaccine. She cannot sleep well. She spoke to an allergist 4/23, who advised her to go to ED, she did not go. Husband called on call MD, who advised her to go to ED 4/23, she did not go. 4/28 called Covid 19 hotline, advised to go to ED.
46 2021-04-28 numbness, tingling, pain in extremity Initially, back pain was all along spine. Later pain concentrated in lower back around base of spin... Read more
Initially, back pain was all along spine. Later pain concentrated in lower back around base of spine. Pain radiated outward from base of spine to hips. It hurt to sit down as a shooting pain would occur down my left leg. It hurt to lie down because of the pain on my sides (hips). Later, I began to get tingling and numbness in my legs and feet, especially my right leg. This was most pronounced when trying to sit down, but the symptoms existed in a milder form when lying down or even standing. This course of events has taken place over the past several days. All symptoms have been moderate or mild in intensity. The lower back / base of spine pain and other symptoms continues.
46 2021-04-28 numbness, tenderness It was the 1st dose after talking to the doctor on site and they put me in for extra observation (30... Read more
It was the 1st dose after talking to the doctor on site and they put me in for extra observation (30 Mins). Within 12 minutes I had an allergic reaction and I spent a good two hours plus with them and now I am on the CDC watch app. The two paramedics plus doctor said they had never seen a person have all the symptoms in one shot, till they met me. The doctor said he was amazed at how sensitive my body was to the medicine but was very impressed that I had all my medications, allergic reactions and so on digitally. I go for the 2nd/final shot on 4/29 so hopefully that one doesnt have me down for days bc I leave for the DR on 5/1. I have been home and recovering sine Thursday. I had a fever, chills, my arm went numb, then I had swelling/redness and sore to the touch, chest palpitations, my asthma kicked in with the wheezing, my blood pressure sky rocketed, my sugar jumped up to 300, fatigue, tiredness, then the itching started and diarrhea. Just a lot going on from one shot.
46 2021-04-28 pain in extremity With the first vaccine dose I had a headache, body aches, and a very sore arm (where I received the ... Read more
With the first vaccine dose I had a headache, body aches, and a very sore arm (where I received the vaccine) for a couple of days. Side effects I expected. But with the second dose I initially had a fever of 101 and body aches. As the night/early morning went on my fever increased to just over 103 (with Tylenol) and I had heart palpitations off and on for a couple of hours. Once my fever started to go down the palpitations stopped. I was nauseated, unable to even drink water, and had a headache with chills and body aches for about 36 hours. I am still unusually tired, I have joint swelling on my left side (new for me), and arm pain where I received the vaccine.
46 2021-04-28 pain in extremity Had general body aches and right arm pain but then 30 hours or so after the shot, I noticed a large ... Read more
Had general body aches and right arm pain but then 30 hours or so after the shot, I noticed a large lump under my right arm. It is large and very sore and is uncomfortable to move arm. About 2-3 inches in diameter.
46 2021-04-29 weakness My lymph nodes in my left armpit were engaged. It felt and looked like I had a small water balloon ... Read more
My lymph nodes in my left armpit were engaged. It felt and looked like I had a small water balloon in my left armpit. It was painful to lay on my side. After 7 days, the swelling is gone but putting deodorant on is still tender. in addition, my energy levels went up and down over a 7 day period. Some days getting through work was challenging, even though I was working remotely. Almost 10 days out, I don't feel 100% of where I was before the vaccine.
46 2021-04-29 depressed level of consciousness, seizure, slurring Patient was diaphoretic and dizzy approximately 10 minutes after receiving her first dose of the Pfi... Read more
Patient was diaphoretic and dizzy approximately 10 minutes after receiving her first dose of the Pfizer vaccine. EMT went to the car and patient started having what appeared to be a seizure then the patient started slurring speech and had periods of a blank stare. Patient remained in car and EMT put seat back and continued to talk to the patient. The patient did not know what year it was or where she was. 911 was called and medical lead at site called. Medical lead continued to stay with the patient and talk to patient. Patient's speech and alertness eventually improved. When EMT arrived, patient was able to walk over to ambulance. Patient's speech and alertness to place continued to improve to baseline. VSS and patient did not want to be taken to hospital. Patient drove herself home with follow-up with primary care physician recommended. 2nd dose appointment cancelled.
46 2021-04-29 feeling cold Arm was sore and had a knot at the sight of injection and was red. The next afternoon started feelin... Read more
Arm was sore and had a knot at the sight of injection and was red. The next afternoon started feeling achy and couldn't get warm. Headache. Then, the next morning woke up and left arm pit is very sore.
46 2021-04-29 numbness, tingling Herpes zoster (Shingles) diagnosis on day 5 due to immune response to Pfizer vaccine, rash appeared ... Read more
Herpes zoster (Shingles) diagnosis on day 5 due to immune response to Pfizer vaccine, rash appeared overnight day 4 to day 5. Emergency room visit evening day 3 for extreme numbness in hands and feet in addition to the following: Shooting pains like a wasp was flying around in my body 30 minutes after and still occurring 5 days later. Intense skin itching from day 1 and still occurring 5 days later. Pins and needles sensation in extremities from day 1 and still occurring 5 days later. Hands and feet feel as if they are asleep/numb from day 1 and still occurring 5 days later. Lymph nodes swollen from day 2 and still occurring 5 days later.
46 2021-04-29 numbness About 5 minutes after the injection, I started to notice slight numbing down my left arm and 2 finge... Read more
About 5 minutes after the injection, I started to notice slight numbing down my left arm and 2 fingers. That started to clear up about 10 minutes later, but then the left side of my face from my jaw line up and over my left eye started to feel the slight numbing. That lasted for about an additional 10 minutes and then cleared up. I did notice when I took the bandaid off that night that it was pretty bloody so not sure if the numbing was the result of hitting a vein vs muscle?
46 2021-04-29 pain in extremity, speech disorder I had advised the staff, like I was previously advised, of the mild reaction last time. They had th... Read more
I had advised the staff, like I was previously advised, of the mild reaction last time. They had the shot administered by a Dr there and the personnel were alerted to keep an eye on me. Shot was administered and they kept me at the seat with the doctor for several minutes before placing me in the waiting room. Metallic type taste and smell occurred in less than 5 minutes of the shot. Slight swelling of the tongue and throat. Caused the need to repeatedly clear my throat and more coughing than the first time. Could not catch my breath easily and felt labored. Was light heads, eyes watering and a little ?foggy.? Used my inhaler but that did not seem to help. Used my emergency inhaler a 2nd time about 2 minutes later. Was advised my face and chest were very red and a party sat with me for a bit. Took about 10 minutes before the breathing/coughing finally seemed to be resolving. The party checking on me stayed in the room and rolled a chair with wheels near incase she need to take me to the ER just down the hallway. She also had an epee pen and advised me she had it with her just in case. My tongue and roof (Ridges) of the mouth was noticeably swollen to me after just an hour. After about an hour and half there, the allergic reactions seemed to stabilize and the staff and I both felt we were out of the woods but I was not ok to leave yet. Coughing subsided drastically and color became normal again. Kept there for a little bit longer? I was at the hospital until 5:20pm-ish. Was advised to go home and take another antihistamine, drink a lot of water and rest. They also advised to report adverse reactions stating I had another mild allergic reaction to the 2nd shot. Came home and took another zyrtec and went to bed because I was so tired. Woke up to my arm being extremely sore but the area of the shot was not raised this time but was warm and painful to the touch. Felt very achy, headache, and exhausted the next day like I had the flu. Slept the majority of the next day. Smell and taste resolved within a few hours but the roof of the mouth is still rigid but metallic taste and soreness is gone. I can tell the tongue is no longer swollen. It?s no longer bulging to the side of my teeth and I no longer seem to have a little lisp. This is now April 30, 2021 at 8:15am.
46 2021-04-29 pain in extremity Right after my injection, my arm became sore, but then by 6 hrs, I could not use my arm due to extre... Read more
Right after my injection, my arm became sore, but then by 6 hrs, I could not use my arm due to extreme pain. Spouse had to dress me. Then I was able to start using my arm by day three. My arm is still having pain and I have limited use of it and it's 4/30/21
46 2021-04-29 pain in extremity My whole upper left arm hurts, and the pain worsens when I move it. I also feel weak in my left arm.... Read more
My whole upper left arm hurts, and the pain worsens when I move it. I also feel weak in my left arm. The right side of my lower jaw hurts, and it worsens with movement. I took Tylenol, but it did not alleviate the pain.
46 2021-04-29 pain in extremity 10 minutes after injection "passed out in vehicle", unsure for how long. Then regained consciousnes... Read more
10 minutes after injection "passed out in vehicle", unsure for how long. Then regained consciousness and passed out 2 more times. RN came to vehicle and took BP and was normal. Pt given crackers and juice and was able to stay alert and oriented and then able to drove home. Later that pm about 8:00 states passed out again for about 1 hr. No other symptoms present other than continued sore arm.
46 2021-04-30 hypersensitivity of all senses, tingling Chills, body ache head to toe, sensitive and achy skin, tingly feeling on arms, bottom of feet, fati... Read more
Chills, body ache head to toe, sensitive and achy skin, tingly feeling on arms, bottom of feet, fatigue, headache. Had the same symptoms after the first shot and they lasted 48 hours before I started feeling better.
46 2021-04-30 numbness, tingling Patient reported top lip swelling 25 minutes after injection accompanied by a sudden rush of numbnes... Read more
Patient reported top lip swelling 25 minutes after injection accompanied by a sudden rush of numbness/tingling up the left side of her neck to the left side of her jaw and cheek. SHe is still experiencing this symptom 48 hours post immunization but has improved.
46 2021-04-30 numbness Next day: 24 hours aches, chills (did not take temp) Following day: Okay Following day: PT appt for ... Read more
Next day: 24 hours aches, chills (did not take temp) Following day: Okay Following day: PT appt for ankle, light exercise. Down and out by that evening. Severe left side headache/eye area. Very stiff neck. Overall fatigue. Not a migraine but extreme pain and nausea; needed Sumatriptan to break pounding headache. Would last a few hours or for sleep, then come back again. 3 days of this. Fatigue in limbs, a bit of light numbness, feeling of overworked legs without having done anything physical. General fuzziness and feeling of not being well/myself.
46 2021-04-30 migraine Vomiting all night and morning until I went to the ER Uncontrollable body trembling Migraine
46 2021-04-30 numbness and pain in extremities, muscle spasms Experiencing neuropathy in both feet/legs/hands; intense cramping in both calves; nausea; This is a ... Read more
Experiencing neuropathy in both feet/legs/hands; intense cramping in both calves; nausea; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 19Mar2021 17:30 (Batch/Lot Number: ep75534) as single dose for covid-19 immunization. Medical history included cancer survivor from an unknown date and unknown if ongoing , chemotherapy from 2017 to an unknown date, known allergies: penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced experiencing neuropathy in both feet/legs/hands, intense cramping in both calves and nausea for past 4 weeks on 20Mar2021. No treatment was received for the events. The patient did not recover from the events.
46 2021-04-30 pain in extremity, breast pain shingles; pain to her back; red spots on left breast; pain left breast; itching on left breast/itchi... Read more
shingles; pain to her back; red spots on left breast; pain left breast; itching on left breast/itching on back; left arm sore; Headache; can barely move; This is a spontaneous report from a contactable consumer (the patient). A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0150, Expiration date: Unknown) via an unspecified route of administration, administered in left arm on 11Apr2021 12:15 (at the age of 46-years-old) as single dose for covid-19 immunization. The patient's medical history was not reported. concomitant medications was none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021-13Apr2021, the patient had a headache at 14:00 and a left sore arm at 16:00. On 14Apr2021 she noticed red spots on her left breast at 12:00 which she thought was the seam of her bra and pain left breast at 12:00 for which she visited physician clinic. On 15Apr2021-16Apr2021 she had itching at 15:00 /pain at 02:00 on her back; for pain back she visited physician clinic and thought it was poison ivy. On 20Apr2021, she went to the doctor for shingles 14:30 at. Stated that the pain is unbearable sometimes and can barely move. Stated that she was told to report it because it may be related to Covid vaccine. Stated that her second shot is 03May and wanted to know if she should get it and she will be fine or should not get the second shot. The patient received treatment with Ibuprofen for headache and pain left breast. Stated that she was given Valcyclovir. At the time of report, it was reported, headache recovered completely from 3-4 days later. Stated that the pain from the shingles comes and goes. Outcome of the event: headache- unknown; left arm sore recovering, red spots on left breast- recovering; itching on left breast/itching on back, can barely move- not recovered and pain left breast, shingles, pain to her back- reported as not recovered (worsened). No follow-up attempts are needed. No further information is expected.
46 2021-04-30 pain in extremity Mild soreness in arm; Mild headache; had some chest tightening like indigestion; her stress level wa... Read more
Mild soreness in arm; Mild headache; had some chest tightening like indigestion; her stress level waxes; chest tightening almost feels like heartburn; her weight sometimes fluctuates by 5 pounds; This is a spontaneous report from a contactable Nurse reported for herself. A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in Deltoid Left on 28Mar2021 15:30 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Medical history included ongoing raynaud's phenomenon diagnosed when she was 14. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE) taken for menopausal symptoms from an unspecified start date and ongoing. The patient experienced mild headache on 28Mar2021 with outcome of recovered, chest tightening almost feels like heartburn (dyspepsia) in 2021 with outcome of unknown, her weight sometimes fluctuates by 5 pounds in 2021 with outcome of unknown. The caller reported that a couple of days after she had some chest tightening like indigestion. Caller stated that she has no history of indigestion or cardiac issues. Caller stated she has never experienced this before. Caller stated she checked her blood pressure and her pulse, and they were fine. She did not believe that the chest tightening was life-threatening, but that it was unsettling. Caller stated it did feel like a band or circle around her bra line and now it is right behind her sternum. Caller stated it was intermittent. Caller stated she has not had any diet or medication changes. Caller stated her stress level waxes and wanes because she was a nurse. Caller reported that the soreness in her arm began within about 5 hours of receiving the first dose of the Covid-19 vaccine and resolved completely within 24 hours. Caller reported that the mild headache began within about 5 hours of receiving the first dose of the Covid-19 vaccine on 28Mar2021 and resolved completely within 24 hours.
46 2021-04-30 cold extremities Pt presented to observation @725 @740 pt began to c/o vertigo and drowsiness Pt vitals taken 139/88... Read more
Pt presented to observation @725 @740 pt began to c/o vertigo and drowsiness Pt vitals taken 139/88 pulse 96 oxygen 100 Denies c/o throat /swallowing difficulties, itchiness Able to follow commands and speak complete sentences. Drank water, apple juice, and graham crackers offered and pt declined. Pt then c/o bilateral arm chills/cold c/o down to bilateral thighs. Advised to wait additional 15 minutes for observation. @755 pt reports she is feeling less cold but s/s of cold/chills remain and dizziness/vertigo better. Pt ok for d/c per Dr Pt left w/husband independently.
46 2021-04-30 tenderness Pt got 2nd Pfizer shot on Thur 4/29/21 in left arm. Came in today to report swelling, redness, warmt... Read more
Pt got 2nd Pfizer shot on Thur 4/29/21 in left arm. Came in today to report swelling, redness, warmth, and itching below the injection site, and axillary tenderness. Pt stated reaction started just this morning. Pharmacist suggested Tylenol, ibuprofen and cool compress, and to report to PCP if condition worsens.
46 2021-05-01 numbness Immediately following vaccine I experienced rapid heart rate, small tightness in chest, and shortnes... Read more
Immediately following vaccine I experienced rapid heart rate, small tightness in chest, and shortness of breath. I had to remove my mask to breathe. I stood from feeling my heart race, but then felt dizzy and sat again. It felt exactly like what happens when I eat shellfish, only it eased faster. Symptoms improved after five minutes of deep slow breathing. My heart raced longer, than five minutes but were not bothersome after five minutes. The attendant watched me the full half hour and was prepared with epinephrine if my airway swelled. He offered me benadryl, but i took it at home instead. That night my neck swelled slightly around my thyroid and my throat felt itchy. . I took two Benadryl and went to bed. Today the right side of my face is slightly numb, but moves normally and is not drooping. I have had bells palsy immediately after 2009 H1N1 vaccine, and same allergic response hr and breathing after varicella vaccine. All other vaccines have not been a problem.
46 2021-05-01 numbness 5 days after first dose, tips of toes on both feet and one finger on right hand started to develop p... Read more
5 days after first dose, tips of toes on both feet and one finger on right hand started to develop petechiae. Red/purple raised blisters formed. Painful, cold to touch. Contacted a provider for video visit. Told this was " covid-toes" due to exposure or reaction to vaccine. Advised to use antibiotic ointment and wrap feet for warmth. Employer contacted at this time and told of symptoms. I was sent home, and swabbed nasally for testing. Covid -19 test was negative at this time. Returned to work. Condition worsened significantly after second dose of vaccine. Tips of toes turned blue, cold to touch and numbness started. blisters worsened. Painful to walk at this time. Had another video visit. Told this could be an auto immune disorder that was dormant triggered by vaccine, or reaction. Advised to elevate feet, wrap and wear socks continually for warmth. Go to ER is numbness continued. ER visit in my town at this time was very long and advised to go only if needed. Condition stayed the same for whole month of jan. Blisters healed beginning of feb. However red scars/left. Then tips of toes tuned blue. feet went numb for hours at at time. I kept a diary and pics of all events
46 2021-05-01 muscle spasms, tingling, numbness within minutes after the vaccine, I sat in the observation area and both my legs from my hips down t... Read more
within minutes after the vaccine, I sat in the observation area and both my legs from my hips down to my feet started feeling numb and tingly. This lasted for over an hour. Honestly I did not report it at the site because I needed to get back to work. I did not seek medical attention because my legs started to feel normal after about an hour. Additionally my period that I had already started became heavier that usual. Normally I only bleed large clots of blood for a few days but this time it lasted for 5 days, large clots the entire time. Approximately 8 hours after my injection, all of the muscles in my body felt very crampy and achy and I felt extremely tired. The next day my throat was sore and but the aches and muscle cramps had improved but were still there. It took several days until I felt myself again.
46 2021-05-01 nerve pain Projectile vomiting, diarrhea, fever, burning nerve pain on left side of body,.
46 2021-05-01 pain in extremity, numbness The morning after the second vaccine I had throbbing and stabbing pain in my feet. The pain shot up... Read more
The morning after the second vaccine I had throbbing and stabbing pain in my feet. The pain shot up my legs which made it almost impossible to stand or walk. The pain has not subsided since then. I have a lot of muscle weakness in my calves and legs. The pain makes it very hard to sleep which is leading to exhaustion. I also have numb fingertips.
46 2021-05-01 pain in extremity Severe headache for about 5 hours and drastically sleepy. My hands broke out with blisters and cuts.... Read more
Severe headache for about 5 hours and drastically sleepy. My hands broke out with blisters and cuts. I could not bend them. It spread on the front and back of both hands. They are still messed up. I have to take showers and clean with gloves on my hand because even water burns it. I have to wear white cotton gloves all around after I wash, clean, and medicate my hands. My entire lifestyle is effected because I am now limite din wha I can do or it takes a lot longer. I can't perform my job as normal. Itcould be a disability but I can't afford to not work, so I deal with it.
46 2021-05-01 pain in extremity The shot was ia the left arm. however, within one hour my right arm began hurting. I woke up a coup... Read more
The shot was ia the left arm. however, within one hour my right arm began hurting. I woke up a couple of days later in excruciating pain - my right arm had sharp pain throughout it, I couldn't pin point it because it felt like everywhere. I lost the ability to grip with my right hand and lost some range of motion. The pain started decreasing after a couple of days then plateaued. I I have regained full motion and most grip but I?m still in a lot of pain.
46 2021-05-02 facial pain Beginning Tuesday April 13, 2021, the right side of my face begin to swell. As the week went on, I s... Read more
Beginning Tuesday April 13, 2021, the right side of my face begin to swell. As the week went on, I started breaking out into hives on the right side of my head, face and my upper back. I started feeling throbbing pain in my head and the swollen area of my face. On Sunday, April 18, 2021, I started to feel better with the help of taking 2 Tylenol 500 mg every 6 hours. As of today, the top of my head hurt and when I scratch my head on the right side it feels like Im scratching with razors. Also, I still have a little swellen under my earlobe on the right side. I was scheduled to take my second dose today, but I am afraid that I will have the reaction that I had with the first dose. Please advise
46 2021-05-02 hot flush The first shot in January gave me migraines on and off over the next 5 days, based on the left side ... Read more
The first shot in January gave me migraines on and off over the next 5 days, based on the left side of my head. I usually get a migraine before my period, but always on my front right area behind my eye and above my ear, and only for 1 day. It was noticeable because they kept coming back and it was in a place I've never had a migraine start. The second shot however on 2/9/21 is my main concern. my period was just ending after about 4 days. a bit of spotting, but it was basically done. The next day after my shot though, I woke up soaked in blood. I spent the next 7-8 hours going through 7 Super-size Tampax Tampons. It seemed like I was flash flooding blood which was weird because ..well if my lining had just shed over the previous 7 days, where did all the blood come from? It ebbed within 24 hours and was back to normal the day after that before it ended. Over by 2/12/21. And now, it is 5/3/21 and I have not had a period since and have basically had early menopause jump in and get hot flashes every day! I read that its not actually menopause until our period has been gone for 6 months or more, and mine has really only been nearly 3, but I'm pretty sure I just got sterilized. And I was a healthcare worker so I got it early, and I don't think the older people getting the shot in line before me would have been raising the concern about their menses cycles because they don't have them anymore.
46 2021-05-02 numbness Head fuzzy, head pressure, head aches - started day of shot and still happening 12 days later Ears r... Read more
Head fuzzy, head pressure, head aches - started day of shot and still happening 12 days later Ears ringing - started 2 days after shot and still happening 12 days later Pain, then numbness/weakness/tingling in right side (face, arm, hand, leg, foot) - started day of shot and still happening 12 days later Sensitivity to noise - started 3 days after shot and still happening 12 days later
46 2021-05-02 numbness At approximately 1415, patient reported minor swelling/numbness traveling from her left arm up to th... Read more
At approximately 1415, patient reported minor swelling/numbness traveling from her left arm up to the left side of her face. Patient advised to wait for further observation. At approximately 1430, patient reassessed. Patient had no difficulty breathing. Lead nurse educated patient educated on signing up with V-Safe, seeking emergency care for any difficulty swallowing/breathing, and following up with primary care provider about her reactions to the vaccine.
46 2021-05-02 numbness LIP TINGLING AND FACIAL NUMBNESS
46 2021-05-02 pain in extremity, tingling as soon as I got the vaccine I felt a small shooting pain on my right leg. the first 2 days I felt ... Read more
as soon as I got the vaccine I felt a small shooting pain on my right leg. the first 2 days I felt nothing out of the ordinary. Chills, sleepy. as days progressed I started to feel something that was more that chills, uncomfortable teeth feeling, some shooting tingling in feet and fingers, then on it started to feel uncomfortable to specially at night and early morning. Doctor said it was paresthesia and that a nurse said she had seen other paitients with similar symptoms. April 6 and 7 I had a fever all day long. Still have chills all over but it feels more than that, it's more like a paresthesia kind of thing. Very uncomfortable and I have been so worried. I have a 6 year old daughter so not getting 2nd shot.
46 2021-05-02 pain in extremity, tenderness 4/10 Muscle pain of left arm developed 1-2 days after vaccine. Pain is aching, constant, and travels... Read more
4/10 Muscle pain of left arm developed 1-2 days after vaccine. Pain is aching, constant, and travels to lower left arm and left shoulder. At time of visit pain was at day 8. Minor improvement in last 24 hrs. Mid upper arm tender to palpation. Denied any other symptoms. Treatment: Ibuprofen, OTC muscle rubs, heat and gentle massage. Contact PCP if pain does not continue to improve in 3 days or if new symptoms.
46 2021-05-02 pain in extremity 4/29/21- date of shot, tongue tingling, throat swelling within 10min of shot 4/30/21- fatigue, sor... Read more
4/29/21- date of shot, tongue tingling, throat swelling within 10min of shot 4/30/21- fatigue, sore arm 5/3/21- headache, sore throat, tongue tingling/swelling, throat swelling (moderate)
46 2021-05-02 pain in extremity Congestion, fever, common cold, severe neck pain, swelling and pain in index finger, headache
46 2021-05-02 tingling, tremor, cold sweat After 24hours, heart palpitations began, occurring every few minutes. (Still occur today) And sligh... Read more
After 24hours, heart palpitations began, occurring every few minutes. (Still occur today) And slight congested cough. Visited Primary Care Tuesday Visited ER, Thursday, ran xrays of chest, took blood, monitored heart. Detected palpation, tests returned normal though with symptoms recommended cariologist. Visted Cardiologist next day for consulation. Scheduled follow-up Holter & Echo two weeks out Friday March 2nd apx 11:45 PM, racing heart started and continued 4 hours along with continued palpations. Normal resting pulse is around 70, Friday March 2nd was 120 at rest. Slowed around 4AM, felt terrible, some nausea, exhaustions, off balance. Racing heart has continued to flare up randomly and usually at rest or at a slow walk. Will occasionally go for a few days of "normal" and will flare again. Wore Holter for 48 hours, no major abnormalities Echo showed normal results. 4/12 Been having pain behind left knee, contacted/visited primary care Sent me for imaging and testing at ER. Normal results. 4/21 - afternoon notes, one month out from first vaccine date: pain in upper back between shoulders pain in lower back similar to mensural pain Chest heavy as if congested Exhausted Feeling off, not dizzy but more like on a boat Drinking tons of water Took Ibuprofin at 4:30 (and baby asprin in AM) (felt the same the prior afternoon though felt fine in that evening through though morning) 2:45 AM woke up soaked in sweat. Heart rate has been in low 90s to 112, had chills/shakes on and off. No pain to note. Only strained and a bit achy. 4:22 AM Feeling awful. Off balance and base of my neck hurts, hip/butt joint pain. Barely slept. Heart rate still high. Not comfortable driving, Feeling shaky, like too much caffeine. Upper back betwee shoulder aches. stomach feels off. trying to eat a piece of bread. Dry mouth, drank about 4 pints of water during the night. 4/23 taking 5mg propranolol 2xs Wed- Friday 28th - 30th mid day were good days, no heart palpitations or racing and no other major symptoms except tiredness. Friday afternoon went on a very slow short walk and my pulse went up to 156 during this time. An hour later went very slowly to check on my boy fishing at the end of our yard and the same, high pulse. Started feeling off after this. Very tired Went to bed Woke up in a cold sweat twice Had mild pressure in my breast bone area and back Feeling tingly/spacey No high pulse Discomfort sleeping on left side (5/1) Tired Lower back achy Mild chest pressure Normal pulse 71 Still have mild congested cough 5/3 (today) Still having periodic racing heart with Beta Blocker. Very tired Little to no appetite Achy back Primary Care, Dr., running additional testing (current, waiting results) Stress test with Cardiologist tomorrow 5/4
46 2021-05-02 seizure Seizure
46 2021-05-03 migraine Joint pain, skin pain, muscle pain, fever, headache, migraine, eye pain, eye discharge, vaginal disc... Read more
Joint pain, skin pain, muscle pain, fever, headache, migraine, eye pain, eye discharge, vaginal discharge
46 2021-05-03 migraine I've had a migraine, almost consistently, for almost a month. No medicine is helping it.
46 2021-05-03 restless legs syndrome about 7 hours after receiving the second covid shot, pt began experiencing severe restless legs. It ... Read more
about 7 hours after receiving the second covid shot, pt began experiencing severe restless legs. It was so bad she was unable to sleep. The restless leg last through till ~4 pm on 4-May-2021. After that pt got the chills.
46 2021-05-04 bell's palsy Bells Palsy
46 2021-05-04 muscle spasms, tremor, muscle twitching, pain in extremity, tingling 12 hrs after vaccine I was awaken by stabbing pain in my right thigh and chest pain. Pain lasted ab... Read more
12 hrs after vaccine I was awaken by stabbing pain in my right thigh and chest pain. Pain lasted about 5 min, after which my muscles started rapidly twitching all over body. Muscles are twitching every few seconds, I am having multiple muscle cramps at random times, sharp intermittent pain all over body. I started having frequent tremors in my hands, muscles feel strained and it is difficult to walk or perform on the piano (my job). 2 days ago I started experiencing constant pins and needles all over my body. My pulse is in the 80s (normally in the 60s), I feel frequent heart palpitations.
46 2021-05-04 pain in extremity I got shingles on my back and on two places in the chest with extreme pain going all the way into my... Read more
I got shingles on my back and on two places in the chest with extreme pain going all the way into my left foot.
46 2021-05-04 pain in extremity Dose 1-04/11/2021,. Mild Swollen Tongue, sore left arm, mild body aches Dose 2-05/04/2021-Moderate S... Read more
Dose 1-04/11/2021,. Mild Swollen Tongue, sore left arm, mild body aches Dose 2-05/04/2021-Moderate Swollen Tongue, Moderate Left arm, moderate body aches, difficulty breathing, and mild headaches.
46 2021-05-04 tremor Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency... Read more
Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move; tremor increased; post COVID syndrome & orthostatic hypertension.; post COVID syndrome & orthostatic hypertension.; Lymph node pain; Tilt Table Testing confirmed Covid-induced POTS; mild injection site pain; COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain).; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID; dizzy; Fatigue; vasovagal response; Passed out; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:30 (Lot Number: EL9261) (at the age of 46-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included infectious mononucleosis (Recent mono) in 2020 (Spring), urinary tract infection (UTI) in 2020 (Summer), venous Insufficiency on Dec2020, shingles in past on an unspecified date, lactose & gluten intolerance from an unknown date and unknown if ongoing, COVID-19 from Jun2020 to an unknown date (I had recovered from mild COVID in Jun and Oct2020 that required no hospitalization and was managed with DAYQUIL, XYZAL, Prednisone, Vit D and melatonin). Concomitant medications included ibuprofen at 2400 mg and 800 mg; pregabalin (LYRICA); progesterone; bifidobacterium bifidum/bifidobacterium lactis/bifidobacterium longum/lactobacillus acidophilus/lactobacillus rhamnosus (PROBIOTIC), all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient experienced mild injection site pain, COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain), dizzy, fatigue, vasovagal response, passed out, nausea, throwing up, tremor increased, chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move, post COVID syndrome and orthostatic hypertension, tilt table testing confirmed COVID-induced POTS (postural orthostatic tachycardia syndrome) and lymph node pain, all on 05Feb2021 at 11:00. All events were serious disabling and required hospitalization. The patient underwent lab tests and procedures which included computerized tomogram (CT): unknown results on an unspecified date, D-dimer: 1300 is very elevated, it shows that I have a lot of inflammation in my body or I could have the clot, 1300, almost 3 times the normal value; magnetic resonance imaging head (MRI): unknown results on an unspecified date, SARS-COV-2 test (nasal swab): negative on 19Feb2021, tilt table test: COVID-induced pots on 05Feb2021 . Unspecified therapeutic measures were taken as a result of the events. The patient outcome of the event passed out was unknown and not recovered for all the other events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-05-05 numbness, pain in extremity, tingling 4 days after receiving the vaccine, I woke up with slight pins and needles sensation; and some numbn... Read more
4 days after receiving the vaccine, I woke up with slight pins and needles sensation; and some numbness in my thumb, index finger and middle finger of my right hand. These sensations gradually increased. Worked Sunday and Monday. On Tuesday, I woke up with those symptoms plus pain in those fingers and an intense burning pain at the base of my right palm. After ibuprofen, it improved some. Went to work. As I was working, pins and needles sensation started in left pinkie finger, ring finger and pinkie finger of right hand. I was advised to go seek medical care. After an assessment, I was told it was carpal tunnel. I have had no prior history of this and I've never experienced these symptoms before. I was given a brace for each wrist.
46 2021-05-05 numbness With the first shot, my arm was numb and felt like it had a bruise but there was no bruise. With the... Read more
With the first shot, my arm was numb and felt like it had a bruise but there was no bruise. With the second shot, my arm turned red and hot at the shot site. Where the needle went in was white and the area around it was hard, red, swollen and hot. I have felt numbness in my cheeks and my head has had a slight headache and felt foggy or whoozy at times. I have had body aches as well.
46 2021-05-05 pain in extremity About 3-4 hours after the vaccine was administered she became very tired and had a very sore arm. ... Read more
About 3-4 hours after the vaccine was administered she became very tired and had a very sore arm. The hives started last night (Wed) 5/5.
46 2021-05-05 pain in extremity Woke up this morning with nausea and vomiting yellow liquid. Also has intense pain in low back, head... Read more
Woke up this morning with nausea and vomiting yellow liquid. Also has intense pain in low back, headache, pain in legs and arms, injection site soreness that seems to have spread to L shoulder and neck. Has been experiencing chills but no fever.
46 2021-05-05 seizure, tremor, flushing Pt stated the next day after getting her covid vaccine he gave herself a COPAXONE injection and then... Read more
Pt stated the next day after getting her covid vaccine he gave herself a COPAXONE injection and then started getting flushing, shortness of breath that increased into shakes/convulsions and a fever that would spike and then fall and then spike again. It went on for a few hours until she finally vomited and then started to get better until it just stopped.
46 2021-05-06 numbness, tingling Numbness, Tingling, Pins & Needles in feet, legs, hands, arms, neck and face. Started one week after... Read more
Numbness, Tingling, Pins & Needles in feet, legs, hands, arms, neck and face. Started one week after injection and still ongoing now after 2 weeks of symptoms.
46 2021-05-07 facial paralysis, numbness, tingling About a couple minutes a receiving the vaccine I started having a metal taste in my mouth. My right ... Read more
About a couple minutes a receiving the vaccine I started having a metal taste in my mouth. My right side of my face started to tingle and then felt almost as if it was numb or paralyzed. It lasted for about 15 or 20 minutes.
46 2021-05-07 pain in extremity Patient states that after leaving she experienced double vision starting about 25-30 minutes after h... Read more
Patient states that after leaving she experienced double vision starting about 25-30 minutes after her first dose. It last about 24 hours and was resolved by lunchtime the next day. Double vision was described as seeing two tvs. Patient also states they felt their heart racing but did not check the rate. Also was tired and had a sore arm. Since getting the vaccine, patient reports mixed periods of diarrhea and constipation. Patient did not report to us until her 2nd vaccine appointment at which we refused to give until medical clearance. Patient never called or saw doctor regarding symptoms.
46 2021-05-08 numbness, tingling, feeling hot, burning sensation Around 12 hours after my first Pfizer dose in the L arm i developed tingling on L side of face, full... Read more
Around 12 hours after my first Pfizer dose in the L arm i developed tingling on L side of face, fullness and decreased sensation. Additionally tingling and sense of burning and heat in L arm. I knew it was a neurological side effect so was not concerned about heart issues but was deathly scared I would get Bells Palsy or some kind of MS like condition. Thankfully this has mostly gone away after three weeks. There is nothing I want more than to be fully vaccinated but quite frankly I am too scared to and will not get dose two. I have been fully vaccinated against other illness-even got the yellow fever vaccine when I was supposed to travel overseas and this is the FIRST time I had such bad side effects.
46 2021-05-09 numbness numbness of tongue hand and both legs
46 2021-05-09 pain in extremity, breast pain ~5P began to feel tired. ~5P began to have allergy symptoms - sneezing, nose running Woke up in AM a... Read more
~5P began to feel tired. ~5P began to have allergy symptoms - sneezing, nose running Woke up in AM aching from neck to legs. Left arm sore. left breast sore. Tired
46 2021-05-09 tenderness Swelling in the lower right arm pit, sore and tender to the touch, accompanied by runny nose and som... Read more
Swelling in the lower right arm pit, sore and tender to the touch, accompanied by runny nose and some drainage in the ear for 1 day. Arm pit was swollen for 3 days after which the swelling went down but site was still tender to the touch for 2 weeks. Right arm pit feels a little different than left based on self examination.
46 2021-05-10 discomfort States it was a little raised spot, not red, it was humped over where they gave the vaccine and it w... Read more
States it was a little raised spot, not red, it was humped over where they gave the vaccine and it was sore the next day; quite a bit of discomfort and can tell she has fluid on her joints and both knees are swollen; quite a bit of discomfort and can tell she has fluid on her joints and both knees are swollen; quite a bit of discomfort and can tell she has fluid on her joints and both knees are swollen/neither are red, just swollen; it is both of her elbows also, one is not hurting as bad and her mom felt one and it's inflamed and swollen, it's not red; spot where you could tell where she got the vaccine/little raised spot, not red, it was humped over where they gave the vaccine and it was sore the next day; joint pain/pain in her joints and knees/both of her elbows also, one is not hurting as bad; she ran a little fever; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 just before 11:00 (Batch/Lot Number: ER8735) as single dose for covid-19 immunisation. Medical history included anaphylactic reaction; she had been in a state working and came home and went to a resturant and got her girlfriend some food and thinks it was the black cherry or the peanut oil used for cooking (stated it is not vaccine related). The patient got her Tetanus and Flu shot last fall. Concomitant mediation included vitamins. No additional vaccines administered on same date of the Pfizer suspect and patient has no prior vaccinations within 4 weeks. The patient received the first dose on 07Apr2021 and was fine. She already had an anaphylactic reaction once, so she waited 30 minutes, and everything was fine. She is scheduled for the 2nd dose on 05May2021. Right at the weekend (Apr2021), she had pain in her joints and knees and still does. She thought it was regular side effects and just be one of those that goes away eventually but she is still having joint pain. She has high tolerance for pain anyhow and she has quite a bit of discomfort and can tell she has fluid on her joints and both knees are swollen on 07Apr2021. She took Ibruprofen for swelling. It is both of her elbows also, one is not hurting as bad and her mom felt one; it's inflamed and swollen, it's not red. She stated that neither are red, just swollen. The patient wanted to know how long joint pain usually lasts for symptoms. She read the little paper from the health department they gave her, and it says what are the risks of Pfizer vaccine and it says injection site pain, tiredness, muscle aches, chills. The patient stated that joint pain is different and is a problem to her, she is an active person and it's driving her nuts it hurts to walk or move. She also had the discomfort and asked her mom who had the vaccine but she (patient's mom) didn't have it, she has bad lung (her mom who is a nurse is still working on bronchitis and has been with bronchitis since December of last year and her mom has lung issues and she has been to a pulmonologist this month. The patient stopped work to be the primary care giver and has not worked since Nov of last year. The patient stated she would be the factor to bring it in the house) and had it in Feb2021 and they have been quarantined since Nov last year and go out once a month for gas for the mower and that is an outing that is safe for her. She stated that the issue is she was looking forward to doing this, she tried to get it in Feb2021 and got it in Mar2021 (patient clarified that she got the vaccine on 07Apr2021). She read the instructions and had some discomfort but it didn't point toward this and she has been working mowing the yard and working out and fixing the garden and thought she had over done it and had lactose build up. It didn't go away about 2-3 days into it and it got to where she had problems, they have 2 dogs and when they bounced on the bed her joints hurt, it was like being jabbed with an ice pick through her elbows. This morning, the patient woke up and went to fix grits and walked down the steps like a 90-year-old woman holding on to both railings because her knees were hurting. She spent the week in the gardens tilled and planted okra and a lot in the garden. On Monday 12Apr2021, she got the discomfort and thought it was from the garden and being on and off the tractor and on her knees planting and built some lactose but it progressively got worse and Tuesday morning she had the problem of the aching in all 4 joints. She read her information for the second dose from the health department and thinks it may be vaccine related, stated she didn't have any at all. She is over the aching. She is a beekeeper by trade and stings don't bother her and this feels like someone hit her with a baseball bat in the joints. She has a high tolerance for pain. The patient has been taking Ibuprofen and she started that 2 days ago and took 3 twice a day via her mom's instruction and it helps her to sleep and work. The patient stated that it is not a normal joint pain, she thought she had overworked herself and had lactose build up and it would work out but this stuff doesn't go away not like normal overworked muscle; the joints have sharp needle pain, like huge shin splint. The patient also had a spot where you could tell where she got the vaccine and she noticed that the same night of the vaccine (07Apr2021). It was a little raised spot, not red, it was humped over where they gave the vaccine and it was sore the next day (08Apr2021). For 2 days, she ran a little fever and as she worked the vaccine out of the muscle it went away. The patient stated that these are not abnormal like her knees and elbows. There is definitely swelling in her knees and when she stands up the swelling moves down. About an inch below the knee there she can tell there is a cuff of swelling below the joint. She noticed this Monday 12Apr2021 also. One elbow feels swollen and worse and they take turns at aching, only one spot at a time. The patient was just wondering about how long this is going to act like this and if she is doing the right thing taking a particular medication because with the J&J with blood clots, they say no heparin. The patient was wondering if there is a specific medication to take or avoid. The outcome of the event joint pain was not recovered while fever was recovered on an unspecified date. The outcome of the other events was unknown.
46 2021-05-10 hot flush had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills;... Read more
had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills; fatigue/ extreme fatigue; severe hot flashes; light headed; lips began to swell; heart rate and blood pressure were up; heart rate and blood pressure were up; did not feel that she was back to her "normal" as it were before receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Apr2021 07:15 (lot number: EW0151) at age of 46 years as single dose for covid-19 immunisation. The patient medical history included known allergies: Sulfa drugs and penicillin. Concomitant medications included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) daily received within 2 weeks of vaccination. Patient had historical vaccine included the first dose of BNT162B2 (lot number: ER8733) via an unspecified route of administration, administered in right arm on 24Mar2021 07:15 at age of 46 years as single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant. It started with low grade fever, chills, fatigue and severe hot flashes, within 12 hours of the shot. Then the next day, extreme fatigue and light headed. Four days later the fatigue was still coming and going and then her lips began to swell, her heart rate and blood pressure were up and she had an allergy induced asthma attack. That was when she went to the hospital. They gave her a liquid shot Pepcid and prednisone with a bag of iv fluids. And sent in prescriptions for Benadryl, prednisone and Pepcid. Patient had taken them for a week. Patient was still suffering from some fatigue that came and went with her heart rate that appeared to be elevated. Patient did not feel that she was back to her "normal" as it were before receiving the vaccine. Adverse event start date was on 18Apr2021 10:30 AM. Adverse events resulted in emergency room/department or urgent care, hospitalization. Treatment was received. Since the vaccination, patient had not been tested for COVID-19. Outcome of events was recovered/resolved with sequel.
46 2021-05-10 muscle twitching Chest discomfort intermittent for 3 hours after vaccine admin, and then again later that evening. m... Read more
Chest discomfort intermittent for 3 hours after vaccine admin, and then again later that evening. muscle twitching lasting for 4 to 5 days post injection moderate
46 2021-05-10 pain in extremity This is a spontaneous report from a contactable consumer (patient, self-reported). A 46-year-old fem... Read more
This is a spontaneous report from a contactable consumer (patient, self-reported). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after her first dose of the vaccine, she had arm soreness, tired, chills, fever, body aches and pain for 2-3 days and then went away. The patient also received the second dose of vaccine on Friday morning and at evening she reported that she had a sore arm, nausea and feeling tired. On Saturday and Sunday, she reported that she was feeling tired and dizzy. Today, she was no longer tired but still had dizziness. There was no information about blood pressure changes as a side effect. Outcome of the events was recovered on an unknown date. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
46 2021-05-10 pain in extremity body aches; headache; nausea; chills; sore arm; swelled lymph node under the arm; This is a spontane... Read more
body aches; headache; nausea; chills; sore arm; swelled lymph node under the arm; This is a spontaneous report from a contactable other health care professional. A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 15Apr2021(at the age of 46-year-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient experienced body aches, headache, nausea, chills, sore arm and swelled lymph node under the arm the evening after receiving the second dose on 15Apr2021. The outcome of the events (body aches, headache, nausea, chills, sore arm) was recovered on 17Apr2021 and swelled lymph node under the arm was recovered on 22Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-05-11 flushing Patient became lighheaded,nauseous and flushed 10 min post vaccine. Moved patient to floor to prop u... Read more
Patient became lighheaded,nauseous and flushed 10 min post vaccine. Moved patient to floor to prop up legs. Gave cold compresses and water. Pharmacit took BP reading and it was elevated. Pharmacist interviewed patient to find out she had not eaten today or taken BPmeds. Patient complained of trouble breathing; RPH asked if she wanted paramedics to come and she agreed since pharmacist had taken another reading and it was 145/110. Paramedics called and took her to nearby hospital
46 2021-05-11 numbness Right side of body (mostly face) went numb about 20 minutes after shot. After sleeping, 14 hours la... Read more
Right side of body (mostly face) went numb about 20 minutes after shot. After sleeping, 14 hours later still have minimal signs of numbness.
46 2021-05-11 muscle twitching, numbness, facial paralysis first 24 hrs ? 1) numbness and tingling in fingers and arm of vaccinated arm 24-56 hrs ? 1) slight f... Read more
first 24 hrs ? 1) numbness and tingling in fingers and arm of vaccinated arm 24-56 hrs ? 1) slight facial paralysis on left side of face causing muscle twitching when I tried to smile 2) pain, inflammation and redness at the exact site of a scar from a childhood vaccine approx 2-3 inches from Pfizer injection 3) fatique
46 2021-05-11 tingling, flushing Instant swelling of the left lymph node ( visibly seen by witness and was compared to the size of a ... Read more
Instant swelling of the left lymph node ( visibly seen by witness and was compared to the size of a lemon) and swelling of right (minimal) closing throat, inability to swallow and challenge to breathe, tingling in hands, 90% loss of muscle strength in legs, heart palpitations (over 90 bpm - avg. 62), loss of concentration and low Co2, and flushed/redness in skin on neck, face, hands, back. I had many witnesses and 2 called 911 thinking it was anaphylactic shock with continuous throat swelling. Paramedic said that it did not appear to be an allergic reaction but could clearly see my lymph nodes swelling. Provided oxygen, Benadryl, IV and blood tests. No infection was found and no food allergy in past. I could not move my legs for a couple of hours but eventually had swelling, muscle strength decrease and return back to normal by the end of the evening. My first dose had no symptoms. However, I placed my hormone patch on the same arm of the second vaccine that week (*note -have used for over a year with no adverse reactions). Possibility of lymph node overdrive or anaphylactic shock with the combo? Should be looked into. Very serious, life threatening event.
46 2021-05-12 bell's palsy Developed Bells Palsy on 4/23 after initial Covid vaccine on 4/9. Went to Urgent Care on 4/24 and w... Read more
Developed Bells Palsy on 4/23 after initial Covid vaccine on 4/9. Went to Urgent Care on 4/24 and was prescribed Prednisone. Went to the Neurologist on 4/29. Had an MRI on 5/6. No other issues than inflamed facial nerve was found on MRI. I am on 3 weeks of Bells Palsy and starting to see a very small improvement on the right side of my face which is the side that has been fully paralyzed.
46 2021-05-12 hypersensitivity of all senses Patient developed rash and sensitivity to touch on left forearm. after receiving Pfizer Covid vaccin... Read more
Patient developed rash and sensitivity to touch on left forearm. after receiving Pfizer Covid vaccine at local Pharmacy. Patient tried Benadryl/Zyrtec, ice and kenalog cream at home and felt 90% better. No additional treatment.
46 2021-05-12 tingling, numbness I felt dizzy right after the shot, but that may be normative. The adverse event was that approximate... Read more
I felt dizzy right after the shot, but that may be normative. The adverse event was that approximately 1/2 hour after the shot, I developed numbness and redness in my ears than then traveled across my face and head. There was numbness and tingling that also began to affect my right eye. This episode subsided in approximately 1 hour. I did not see a doctor at that time. Across the week following the shot, I continued to experience numbness and tingling in the face off and on. I first went to a walk in clinic on 5/6/21 and my vitals were checked. A recommendation of trying an antihistamine was made in case the reaction was sinus related. The antihistamine did not appear to help. I saw my primary care physician on 5/12/21 with head/face numbness/tingling still continuing. She noted that this was called Paresthesia and prescribed 100mg of Gabapentin to be taken for two weeks. I am just beginning that treatment at the time of this report. My doctor recommended that I make a report to VAERS since this began right after my vaccine injection. Overall, at this time head/facial parensthesia and off and on dizziness has remained for 2-weeks since my first vaccination shot of Pfizer.
46 2021-05-13 discomfort, numbness, pain in extremity Numbness in left hand and foot; left side of body was heavy and stiff; pain at bottom of left foot w... Read more
Numbness in left hand and foot; left side of body was heavy and stiff; pain at bottom of left foot when walking. Side effects lasted about a month. Not currently experiencing side effects.
46 2021-05-13 night sweats Approximately 24 hours after the 2nd dose of Pfizer BioNTech Covid vaccination I experienced a tempe... Read more
Approximately 24 hours after the 2nd dose of Pfizer BioNTech Covid vaccination I experienced a temperature of 100.1, headache, body aches, night sweats, and fatigue. After 12 hours all symptoms subsided except for the headache which persisted for another 24 hours.
46 2021-05-13 pain in extremity, weakness Woke up the day after the shot and was so ill I could not hold myself upright as I was in the bathro... Read more
Woke up the day after the shot and was so ill I could not hold myself upright as I was in the bathroom. I was nauseated, had a brutal headache, every bone and muscle in my body ached, I had a fever (don?t know how high), every injury I have ever had hurt like it was a fresh injury, and I couldn?t walk to the bedroom. My husband helped me up and as he walked me back, I passed out cold for a minute. I had the chills and vomited several times. That level of illness continued for about 6 hours, then subsided a bit. I took acetaminophen and that helped with the fever. I was sick the entire day into the next day. Then, I was exhausted, had headaches, and had muscle pain and weakness for the next 3-4 days. I finally feel better, but my arm still hurts over a week later.
46 2021-05-13 seizure, tremor Fainting, convulsions, shakes, light headedness, rash on chest, difficulty breathing, neck and face ... Read more
Fainting, convulsions, shakes, light headedness, rash on chest, difficulty breathing, neck and face on the second morning after second dose
46 2021-05-14 feeling hot her throat is itchy.; she was feeling the dizziness.; she had the stomach upset; She also threw up a... Read more
her throat is itchy.; she was feeling the dizziness.; she had the stomach upset; She also threw up all day; hot rush over her body; vertigo; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 46-year-old female patient (weight: 160-170) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, supplemental form, Batch/lot number and Expiration date not reported) via an unspecified route of administration, on 13Feb2021 (at the age of 46 years) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9263 and Expiration date not reported) via unspecified route of administration, in right arm, on 23Jan2021 1:30 in the morning as a single dose for COVID-19 immunization. Proprietary medicinal product name includes Birth control. There were no prior vaccinations within 4 weeks and no AEs following prior vaccinations. She got the second dose on Saturday 13Feb2021. She was fine all day. However, Sunday, when she got up in the morning, she had vertigo which she is still experiencing now. It is like the room spins around. She also threw up all day on Sunday. HCP Stated she does not really have a primary care provider. She only goes to the doctor once a year annually for a physical. The doctor always changes. Therefore, she declines to provide consent to contact primary HCP. Confirmed still has the vertigo but did not really feel it as much yesterday. Overnight on Sunday she felt it some into Monday morning. She feels it some again today this morning, but it is not as frequent as it was on Sunday. She stated she only threw up on Sunday and she has stopped doing that already. However, her throat is itchy. She threw it up all day on Sunday. She felt like she was going to throw up while she was feeling the dizziness. It was like her whole head was spinning around and she had the stomach upset. When she got dizzy she felt like a hot rush over her body and her head would spin. Today she was able to eat oatmeal, but before she could not hold in water. She questioned that is this normal to have vertigo and throwing up after getting the second dose of the vaccine. Outcome of the event vertigo was reported as recovering, threw up was reported as recovered, feeling hot, stomach upset, dizziness, itchy throat as unknown. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
46 2021-05-14 feeling jittery, tingling, tremor, numbness 2 days after vaccine developed constant buzzing & jittering. 3 days after vaccine to ER for arm num... Read more
2 days after vaccine developed constant buzzing & jittering. 3 days after vaccine to ER for arm numbness & tingling. 7 days after vaccine to ER for dizziness & shortness of breath. 10 days after vaccine saw me in clinic with ongoing tremor/jitteriness.
46 2021-05-14 muscle twitching Body twitching. Laid down on recliner. Felt better after liying on the recliner.
46 2021-05-14 tingling states she cant sleep; cant concentrate; tinnitus, ringing of ears; Ear fullness; Tingling in right ... Read more
states she cant sleep; cant concentrate; tinnitus, ringing of ears; Ear fullness; Tingling in right side of face, around eye and cheeks and everything; This is a spontaneous report from /Medical Information received from a contactable nurse reporting for herself A 46 year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206) on 21Mar2021 at single dose via an unspecified route of administration on right deltoid for COVID-19 immunization. Relevant medical history included ongoing autoimmune disease from 2016 (diagnosed about 5 years ago). Concomitant medications were not reported. On 21Mar2021 the patient experienced Tingling in right side of face, around eye and cheeks and everything, started little bit the day of vaccination and then just kept going and got gradually a little bit worse. The events was considered as medically significant. On 23Mar2021 the patient started complaining ear fullness, started to get full like feeling in ear, like plugged under water kind of thing described as ongoing as improved slightly but it comes and goes (as such). The event was considered medically significant. On 27Mar2021 the patient also started experiencing tinnitus, clogged/plugged ears and ringing in the ears. The event was considered medically significant. This was not going away, she also mentioned can' t sleep and can' t concentrate. Patient also informed that she is part of a huge online Support group (1500-2000) for people who have developed tinnitus after covid vaccination with either of Pfizer, Moderna or Jansen and Jansen Covid vaccine. Patient declined to provide information on the persons other people who were experiencing the same symptoms, hopefully, those persons call Pfizer on their own. She also informed that was not be getting her second dose (as such). The patient recovered from 'Tingling in right side of face, around eye and cheeks and everything' on an unspecified date in Mar2021, was recovering from ear fullness, while have not yet recovered from tinnitus, ringing of ears. At the time of the reporting outcome of other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event "tingling in right side of face" with BNT162b2 can not be fully excluded. The association between the events "ear fullness" and "tinnitus" with BNT162b2 can not be fully excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-05-14 tremor, weakness Severe shaking, chills, crying, 102 fever, nauseous, anxiety attack that lasted 4 hours, fatigue, di... Read more
Severe shaking, chills, crying, 102 fever, nauseous, anxiety attack that lasted 4 hours, fatigue, dizziness, and weakness
46 2021-05-15 seizure Grand Mal Seizure noted on May 8th.
46 2021-05-15 tremor 12 hours later, chills and shakes with no fever and significant body pain (strange, not like muscle ... Read more
12 hours later, chills and shakes with no fever and significant body pain (strange, not like muscle aches, felt deeper and more acute). 12-18 hours later, I developed a cough and some tightness in my chest. 2 weeks post shot and the cough and tightness remain. Periodic bouts of fatigue.
46 2021-05-17 weakness I had extreme feelings of weakness and lethargy after the second dose of the vaccine which dragged o... Read more
I had extreme feelings of weakness and lethargy after the second dose of the vaccine which dragged out for weeks. I did not feel shortness of breath, but I just felt very weak. I could not walk or exercise during that time. I had swelling in my lymph nodes. My Lymph nodes under my arm on the right were very swollen for quite a while. I fell down the stairs because my knees while I was so weak during that time. I felt that extreme fatigue for six weeks. It was two months before I felt normal, and I could walk and exercise.
46 2021-05-17 discomfort Pt is uncomfortable a day after receiving it.
46 2021-05-17 numbness, cold extremities, tingling Immediate sensation radiating down the left arm into the hands and fingers. Immediate cold hands an... Read more
Immediate sensation radiating down the left arm into the hands and fingers. Immediate cold hands and feet which resolved after one day. A month later still has some numbness and tingling in the fingers of the left hand.
46 2021-05-17 tremor Dizzy; Very swollen and very painful lymph nodes; Very swollen and very painful lymph nodes; Very na... Read more
Dizzy; Very swollen and very painful lymph nodes; Very swollen and very painful lymph nodes; Very nauseous; shaky; cold then hot; This is a spontaneous report from a contactable Other HCP (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Feb2021 15:15 (Lot Number: EN6201) (at the age of 46) as single dose for covid-19 immunisation. No other vaccine was received in four weeks. No covid prior vaccination, no covid tested post vaccination. No known allergies. Medical history included fibromyalgia, chronic fatigue syndrome, depression, anxiety, I have no spleen either. Concomitant medications included melatonin, duloxetine, bupropion. The patient experienced dizzy on 13Feb2021 03:00, very swollen and very painful lymph nodes on 13Feb2021 03:00, very swollen and very painful lymph nodes in armpit of arm that received the vaccine on 13Feb2021 03:00, very nauseous on 13Feb2021 03:00, shaky on 13Feb2021 03:00, cold then hot on 13Feb2021 03:00. The outcome was not recovered. No follow-up attempts are possible. No further information is expected
46 2021-05-18 feeling hot, tingling, numbness anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations... Read more
anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations; her feet turned like a reddish color; fatigued; chills; felt out of sorts for a couple of days; her throat was a little sore; not feeling well; chest was just hurting; slight nausea; caller kept moving her arm in a circular motion to keep it from getting stiff; numbing tingling in my foot; numbing tingling in my foot; lost my voice; i was in bed for 1 week and 3 days; scary; a warm sensation in her stomach; felt out of sorts; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0170, first dose) solution for injection intramuscular in the left arm on 29Apr2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. Medical history included fibroids (had to have 3 blood transfusions for this), severe allergy to fish and tomato, and chronic anemia (diagnosed with this after she had her children). Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for very bad allergies. Family history included chronic anemia and Hashimoto's disease disorder (grandmother) in 2020. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Apr2021, the patient experienced anaphylactic reaction, heart palpitations, stomach burning, warm sensations, her feet turned like a reddish color, fatigued, chills, felt out of sorts for a couple of days, her throat was a little sore, not feeling well, chest was just hurting, slight nausea, kept moving her arm in a circular motion to keep it from getting stiff, numbing tingling in my foot, lost my voice, felt like I was dying, was in bed for 1 week and 3 days, scary, a warm sensation in her stomach, and felt out of sorts. The events did not require a visit to Emergency room or Physician's office. Unspecified treatment was provided for the event nausea. The outcome of the events heart palpitations, stomach burning, feet turned like a reddish color, throat was a little sore was recovered in 2021. The outcome of the events fatigued, chills, nausea was recovering. The outcome of the event warm sensation in her stomach was recovered on 29Apr2021. The outcome of the other events was unknown. No follow-up attempts are needed. No further information expected.
46 2021-05-18 tingling, numbness Within 20 - 30 minutes of getting the shot my face below my eyes went tingly to numb. Then my throa... Read more
Within 20 - 30 minutes of getting the shot my face below my eyes went tingly to numb. Then my throat became tight and swallowing felt different. About 30 minutes after the onset the symptoms started to subside. Then the around 3:30 pm extreme fatigue set in and I could not stay awake. I slept for 4.5 hours and went back to sleep a short time later all night. 0n 5/18/21 my tongue swelled, my throat hurt and the inside of my mouth and in random spot ached. The swelling went away in about 40 minutes and the sore mouth went away but the sore throat lingered most of the day. I was fatigued again On 5/19/21 I had fatigue again and my eyes hurt, event behind my eyes.
46 2021-05-19 weakness, numbness Pt called health system call center reporting she felt dizzy and weakness. Reported some left sided ... Read more
Pt called health system call center reporting she felt dizzy and weakness. Reported some left sided numbness on her left leg. She had received her pfizer vaccine on 5/3/21 outside of the county from her workplace (but no other information provided). Pt was advised to for to ED as soon as possible
46 2021-05-19 flushing No sleep for two weeks straight; hostile; Angry; could not turn off her brain; whispering to herself... Read more
No sleep for two weeks straight; hostile; Angry; could not turn off her brain; whispering to herself all day/all night; monkey chatter in head; had a flushed face; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 25Feb2021 (Batch/Lot Number: EL 9264) as 2nd dose, single for covid-19 immunisation. Medical history included Pervasive Developmental Delay (on the autism spectrum), penicillin allergy, shellfish allergy from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported and multivitamins. The patient previously took ceftin and ceclor and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 46-years-old on 04Feb2021 (lot number EL 3302) administered in left arm for covid-19 immunisation and no adverse effect was experienced. It was reported that after Pfizer vaccine #2, the patient immediately had a flushed face on 25Feb2021 which disappeared by the next day. The following week on 04Mar2021, the patient was hostile/angry/and could not turn off her brain; she was whispering to herself all day/all night called it "monkey chatter" in her head. There was no sleep for two weeks straight. The reporter called their gynecologist for bloodwork, thinking it could be hormonal, perimenopause; it was not. They called the psychiatrist and counselor for guidance and was recommended Seroquel, to stop the chatter in her head, and to help her sleep. They visited their family physician, who prescribed the medication, 25 mg for bedtime. The patient is finally becoming more like herself, pleasant, no whispering to herself, no monkey chatter in her head, and able to sleep at night with the support of the Seroquel. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. The patient recovered from flushed face on 26Feb2021, and was recovering from the other events.
46 2021-05-19 tingling, pain in extremity, numbness Consistent with Gullian-Barre. Limbs tingling and going numb, significant neck pain on injection sid... Read more
Consistent with Gullian-Barre. Limbs tingling and going numb, significant neck pain on injection side, arm pain continues from injection site, nausea, diarrhea.
46 2021-05-20 numbness, feeling hot, feeling jittery Became pale, hot and diaphoretic within 2 minutes. Entire body became red then faded. Developed hive... Read more
Became pale, hot and diaphoretic within 2 minutes. Entire body became red then faded. Developed hives in 2 hours. Got jittery and numbness in left arm. Itchy throughout the evening. Strange dreams for two nights. c/o tiredness, nausea, and diarrhea the next day. Is currently tired, but feeling better.
46 2021-05-20 tingling At 18:40 pt chief complaint is tingling sensation radiating from R side of her neck up to the top of... Read more
At 18:40 pt chief complaint is tingling sensation radiating from R side of her neck up to the top of her head, head feeling heavy, and dizziness. Pt transitioned from sitting position to laying down. Vitals taken at 18:45 are: Temp-98 HR-74 RR-16 BP-110/90 O2-100%. Pt feet propped up and remained in observation. Pt vitals taken at 18:55 are: Temp-97.5 HR-68 RR-14 BP-125/90 O2-100%. Pt reports tingling sensation to be coming and going and remains feeling dizzy. At 19:08 pt reports feeling like she is going to pass out. Pt is still laying down and being observed. Vitals taken at 19:09 are: Temp-98 HR-95 RR-18 BP-132/84 O2-99%. At 19:30 pt reports tingling sensation is resolved and transitions from laying to sitting. Pt reports feeling slight dizziness but remains sitting independently and stable with observation RNs on standby. Vitals taken while sitting are: Temp-98.2 HR-80 RR-15 BP-124/78 O2: 99%. At 19:35 pt reports resolution of dizziness and feels steady enough to stand. Pt offered EMS follow up, but pt denies. Pt is discharged in the care of her husband and son, advised to follow up with urgent care in the event of any further symptoms experienced at home.
46 2021-05-21 weakness Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Exhaustio... Read more
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: STATING THAT SHE WAS BLANKING ON HER WORDS AND HER FRIEND NOTICED IT WHEN SHE WAS ON THE PHONE WITH HER -Mild, Systemic: Weakness-Mild, Additional Details: CALLED TODAY 05/21/2021 @6PM EST AND SHE STATED SHE FEELS FINE TODAY BUT HAVE ITCHINESS WHICH HOSPITAL PRESCRIBED BENADRYL TO HER, DISCHARGED TODAY IN AM
46 2021-05-21 feeling of body temperature change, numbness, tingling Approximately 40 minutes after getting my second dose of the Pfizer vaccine I developed severe abdom... Read more
Approximately 40 minutes after getting my second dose of the Pfizer vaccine I developed severe abdominal pain and chest tightness. I could not take in a deep breath and became diaphoretic with cold and hot sweats. My ring and pinky finger, both hands, became numb and were tingling with the numbness traveling down to my elbows. I became lethargic and had a feeling of extreme uneasiness followed by a bout of diarrhea. I then fell asleep for approximately 2 and half hours without moving. When i woke up the numbness was gone but I was still fatigued and had intense abdominal pain and still having the feeling that something wasn't quite right. I went to the ED the following day for the pain and general feeling of being unwell. At the ED I had high blood pressure, tachycardia, large amounts of blood in my urine and high WBC in addition to the above symptoms. For approximately two weeks after the initial onset of symptoms I still had abdominal pain and distention and extreme bloating.
46 2021-05-21 numbness, facial pain Pain in Right side of face and numbness. Fatigue, muscle weakness. Dizziness, fainting, shortness of... Read more
Pain in Right side of face and numbness. Fatigue, muscle weakness. Dizziness, fainting, shortness of breath.
46 2021-05-21 tenderness Received lip filler on 5/18/2021 and lips are more swollen then previous fills. More swollen and te... Read more
Received lip filler on 5/18/2021 and lips are more swollen then previous fills. More swollen and tender to touch.
46 2021-05-22 numbness, pain in extremity, tingling The first Dose was administered on March 31. I started staining then bleeding several days after wh... Read more
The first Dose was administered on March 31. I started staining then bleeding several days after which is not normally a part of my menstrual cycle. This continued for several days and times up until the second dose on April 21. I started bleeding again on April 27 which was not my predicted normal menstrual start date. Immediately after the second dose on April 21st I had a sharp shooting pain in my neck and left arm. I waited at the hospital for 30 minutes and no further reaction so I left. On the car ride home I started to get a headache which has continued almost daily since that date. I started to get a pin and needles sensation in my face and fingers about 1 hour after the dose which I assumed was a panic attack. The pins and needles and then slight numbness continued on and off in my face, forearms, hands, fingers, knees, shins, feet, and toes. Still experiencing this today (5/23/21). At Approx 6:30pm on April 21st I began to feel very fatigued. Head was pounding and I started to feel chills. Head to toe Body aches shortly followed and then 101.6 fever kicked in. Body aches and fever lasted for 2.5 days. On April 23 my fever broke. Still in bed from April 21, I was then woken by severe stomach pains. I started vomiting and having diarrhea at the same time. This lasted a few hours. I lost 3 pounds in the first few days following my 2nd dose
46 2021-05-22 numbness Numbness on left side of face at 10 pm. Pain in the left arm staring from the site of injection to t... Read more
Numbness on left side of face at 10 pm. Pain in the left arm staring from the site of injection to the inner side of the left elbow. Difference in facial sensation between bilateral sides. Reported feeling swelling on left-side.
46 2021-05-22 muscle spasms My period had changed. My last regular period was April 17th through 21st. After 1st shot May 1st - ... Read more
My period had changed. My last regular period was April 17th through 21st. After 1st shot May 1st - May 5th I had my period again. Just sheading lining. Not much bleading like normal. I also had bad cramping and headaches. I have a regular cycle like clock work. This month I am late. I started on May 21. I also have no engery and just sheading lining not much blood. I got my 2nd dose on May 15th. I had a low feaver and aches along with chills. I had a sore arm after both shots. It lasted for 2 days and then I was fine. The only weird thing is my period is not normal. I just wanted to report this because talking to Pharmancy Tech told me to report it. I tried using v-safe app but there was not a place to put this. Thanks!
46 2021-05-22 cold extremities Palpitations and cold feet.
46 2021-05-23 involuntary muscle movements Syncope, R25.9 Unspecified abnormal involuntary movements. R55 Syncope and Collapse. I don't rememb... Read more
Syncope, R25.9 Unspecified abnormal involuntary movements. R55 Syncope and Collapse. I don't remember how it happen just collapse, ambulance took me to the hospital.
46 2021-05-23 difficulty speaking, tremor, flushing From her allergist"...since her 2nd COVID vaccination. Within an hour of the shot she felt nauseous... Read more
From her allergist"...since her 2nd COVID vaccination. Within an hour of the shot she felt nauseous and had flushing. She responded to antihstaimines initally but then at 24 hours developed flushing, redness, shaking. Her HR and BP were elevated. Her throat felt tight and she was getting worse despite antihistamines and used her Epipen. Went to ED and given bendaryl, ativan, solumedrol. She felt better and was discharged home. Yesterday she had another bad flare but was feeling better today. Took 60mg prednisone on Sunday and 50mg this AM. After her Xolair she had a significant flare. She felt her whole body flushing and she developed hives and itching. Her voice changed and her throat was tight and she was given epi x2. Also took 50mg of hydroxyzine and was given IV benadryl. She was taken to the ED. I spoke with the ED doctor at 4:30 and she seemed to be better. She was given pepsid as well as zofran and ativan. I spoke with her at 5:45 and she sounded like she was not feeling better. Her voice was froggy and she reported that she did not feel like things were calming down. I spoke with the ED again and asked them to give her another 50mg of hydroxyzine and if still not improving solumedrol. I do think this is in the setting of her vaccination causing an immune stimulation and not related to the Xolair. We discussed that the Xolair should help but may not be immediate. She was to continue tapering steroids to 40mg tomorrow but she should take 60mg if still symptomatic. I asked them to keep her at the hospital until she has significantly improved..."
46 2021-05-25 weakness An hour after injection of Covid 19 vaccine Pfizer I was extremely nauseas and lethargic for 12 days... Read more
An hour after injection of Covid 19 vaccine Pfizer I was extremely nauseas and lethargic for 12 days. Second day after vaccine I could not keep food down and had chills, no fever. Symptoms for strong for entire week and second week slowly improved. I was unable to eat regularly and had to take frequent naps and slept more then usual. Weight loss and weakness.
46 2021-05-25 pain in extremity Beginning the next day, I started to experience an achy feeling in my upper arm, it traveled down to... Read more
Beginning the next day, I started to experience an achy feeling in my upper arm, it traveled down to my lower arm, then by the net day i felt the aching feeling in my wrist. It then went into my other right arm by 3 days post shot. Now all of my joints ache and are uncomfortable all the time (legs and arms). I am having issues picking up heavy items without pain. I feel like I am swollen in all of my joints. I otherwise feel great
46 2021-05-25 pain in extremity Extreme aching in the arm for 5 weeks. So much it's painful. At my second dose, May 11th, I infor... Read more
Extreme aching in the arm for 5 weeks. So much it's painful. At my second dose, May 11th, I informed the tech that my arm still hurt from the first dose which she replied, "that is odd. we'll just do the injection in your other arm". I went another week in pain before calling my dr to inform him of the pain. They took my information over the phone and asked me to keep them updated. Two days ago was just too much pain to bear so i went to the pharmacy and spoke with the pharmacist. she suggested i get an X-ray. I called my dr and yesterday went it to have it checked out. they did an X-ray and found nothing out of the normal. they also ruled out a blood clot since i didn't have any of the symptoms.
46 2021-05-25 tingling, numbness numbness and tingling on right side of face and in right arm and shoulder.; numbness and tingling on... Read more
numbness and tingling on right side of face and in right arm and shoulder.; numbness and tingling on right side of face and in right arm and shoulder.; tingling on right side of face and in right arm and shoulder.; swollen right eye; nausea; severe headache; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH6198; DOSE NUMBER: 1) via an unspecified route of administration on her left arm on 06Mar2021, as single dose for Covid-19 vaccination (at the age of 46 years). Medical history and concomitant medications were not reported. No other vaccines were administered within four weeks. The patient has allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 20:00 (reported as 6 days post-vaccination), the patient developed nausea, swollen right eye and severe headache that had persisted for several days then. On 15Mar2021 (reported as day 3), the patient developed numbness and tingling on right side of face and in right arm and shoulder. The patient underwent Computed Tomogram (CT) scan and Magnetic Resonance Imaging (MRI) (dates and results not reported). The patient received treatment for the events (treatment details not reported). She was taken to emergency room due to the events. The outcome of all the events was unknown. No follow-up attempts are possible. No further information is expected.
46 2021-05-26 pain in extremity Apps 15 hours after- 102 fever, fever of 100; extreme chills; 26 hours after, sever body aches; espe... Read more
Apps 15 hours after- 102 fever, fever of 100; extreme chills; 26 hours after, sever body aches; especially though arms; neck ache; ache kidney area; fatigue, no fever but still tired; This is a spontaneous report from a non-contactable consumer or other non-HCP. A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot number: EN5318), dose 2 via an unspecified route of administration in left arm on 10Feb2021 at 07:15 (at the age 46 years) as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Feb2021 at 10:00, (15 hours after) patient experienced 102 fever and extreme chills. On an unspecified date in Feb2021, (26 hours after), patient experienced severe body aches especially though arms, neck, and kidney area, fatigue and fever of 100. On an unspecified date in Feb2021 (48 hours after), patient experienced slightly achy, no fever but still tired. The treatment was not received for the adverse events. The patient has been tested for COVID-19 (SARS-CoV-2 test): negative on 11Feb2021. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
46 2021-05-26 tingling, numbness, pain in extremity Right upper arm soreness and right hand numbness/tingling
46 2021-05-26 tingling Client indicated she received her vaccine wihout incident at 1330. She sat in observation for 15 min... Read more
Client indicated she received her vaccine wihout incident at 1330. She sat in observation for 15 mins and denies having experienced any side effects. Client reported as she walked to her car, she began to experience vertigo, nausea and tingling. She sat under the tent near the observation area. MD and EMS paged. MD assessed client and recommended client remain in observation until she felt better. Client requested her adult daughter's presence as she waited. Client was observed to be crying during her assessment with MD. Client remained for continued observation. Client exited observation with her adult daughter by her side in stable condition at 1416, denied any side effects at time of departure.
46 2021-05-27 facial pain, numbness, pain in extremity, sensory loss Severe muscle pain in left calf; Severe pain at the injection site; stiff Face muscles; joint pain a... Read more
Severe muscle pain in left calf; Severe pain at the injection site; stiff Face muscles; joint pain all over my body; Muscle pain all over my body; something just felt off; Numbness in my right foot; loss of sensation in my right foot; Neck sore; cheeks, and jaw felt sore; Dizzy; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old Female patient (Pregnancy at time of Vaccination: No) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 09:15 (Batch/Lot Number: EW0167) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04May2021 10:15 AM, the patient developed Severe muscle pain in left calf, Severe pain at the injection site, stiff Face muscles, Muscle and joint pain all over my body, something just felt off, Numbness/loss of sensation in my right foot, Neck sore, cheeks, and jaw felt sore, and Dizzy. The patient was recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 Since the vaccination. No follow-up attempts are needed. No further information expected.
46 2021-05-28 coordination abnormal Within a few hours of receiving the shot, I experienced very very weak legs. I felt I could hardly w... Read more
Within a few hours of receiving the shot, I experienced very very weak legs. I felt I could hardly walk or support myself whenever my feet would touch the ground. I would manage to walk, but with difficulty and a lack of coordination. It was one of the most petrifying experiences in my life! I hope it was temporary, but after a week I visited my doctor and she claimed she had not heard of this effect yet. She did some blood work and requested an ultrasound on my legs. My blood work was all good except for a mildly elevated d-dimer. I didn't have a chance to do the ultra sound yet as I had an urgent trip to attend to. My leg weakness and heaviness cannot be described as pain. It is primarily weakness, heaviness, and discomfort. I feel that I have some sort of neurological disorder after the shot, but I don't really know for sure. The problem, is that I am still facing these issues even a month later! It's less than before and I am not as terrified as I was initially, but I feel there is some sort of permanent damage that has happened. I have opted not to go for the second vaccine under any condition. I actually wish I would have taken my chances with covid as my health and lifestyle are definitely compromised as a result of this vaccine. Some answers and remedies would be really appreciated please!
46 2021-05-28 discomfort Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Within 40 minutes o... Read more
Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Vision blurred; Body grew heavy feeling; Cclumsiness of movement; This is a spontaneous report received from a contactable Other Health Care Professional. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number; EL9262 and Expiration Date was not reported) via an unspeci-fied route of administration in Arm Left on 21Jan2021 15:00, as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, diverticulum, asthma all from an unknown date and unknown if ongoing. Concomitant medication(s) included liothyronine sodium (CYTO-MEL); levothyroxine sodium (SYNTHROID); ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN LO) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers, vision blurred, body grew heavy feeling, clumsiness of movement. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date. Follow-up attempts are completed. No further information is expected.
46 2021-05-28 numbness and pain in extremities Transient b/l LE edema 2d after 2nd dose with neuropathy; Transient b/l LE edema 2d after 2nd dose w... Read more
Transient b/l LE edema 2d after 2nd dose with neuropathy; Transient b/l LE edema 2d after 2nd dose with neuropathy; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received (COVID 19 PFIZER), dose 2 intramuscular, administered in right arm on 13Apr2021 17:00 as single dose for COVID-19 immunization. Medical history included type 2 (DM) diabetes mellitus, obesity, vitamin D deficiency and was diagnosed with COVID-19 prior to vaccination; all from an unknown date and unknown if ongoing. The patient has no known allergies. The patient's concomitant medications were not reported. The patient previously received 1st dose of (COVID 19 PFIZER), intramuscular, administered in left arm on 23Mar2021 05:00 PM for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021, the patient experienced transient (bilateral) b/l lower extremities (LE) edema 2d after 2nd dose with neuropathy. Outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken were NSAID and muscle relaxant. Since the vaccination, the patient has not been tested for COVID-19.
46 2021-05-31 migraine, pain in extremity Migraines, stiff neck, right arm pain, fatigue, muscle aches, swelling in my neck and shoulders
46 2021-06-01 electric shock sensation, coordination abnormal Same day as vaccine, felt adrenaline rush, heightened level of energy the rest of the afternoon and ... Read more
Same day as vaccine, felt adrenaline rush, heightened level of energy the rest of the afternoon and evening. Two days following vaccine, I experienced some muscle coordination issues, dropping things, neurologically felt out of balance and slightly intoxicated. Explained to friends and family that I felt weird and not right in the head. Tiredness followed through next week, followed by extreme sensitivity to loud or high pitched noise. Started having multiple "brain zaps" or "brain fades" where I temporarily felt a rush of brief black, tunnel vision space, followed by panic attack ... left ear ringing at immediate onset. 10 days post vaccine, I had 6 hour episode of intense ringing in left ear. It subsided some and I slept well, very tired the next day. Scheduled appointments with my neurologist and ENT. Episodes resulted in tiredness/fatigue.
46 2021-06-01 muscle spasms excessive menstrual bleeding for 5 days. This is medically unusual as I have not had ANY period in 5... Read more
excessive menstrual bleeding for 5 days. This is medically unusual as I have not had ANY period in 5 years, as I have been in menopause since 41 years old; cramps; heavy period; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 23Apr2021 13:15 (Lot Number: ew0175) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included CVID, hypothyroid and asthma from an unknown date and unknown if ongoing. Concomitant medications included immunoglobulin human normal (CUTAQUIG), montelukast sodium (SINGULAIR) and thyroid (ARMOUR THYROID); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, via unspecified route in the left arm on 30Mar2021 04:45 as 1ST DOSE, SINGLE (lot number: er8733) for COVID-19 immunization at 46 years old. The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient stated that on 11May2021 12:00, "I got a very heavy period, cramps for three days, excessive menstrual bleeding for 5 days. This is medically unusual as I have not had ANY period in 5 years, as I have been in menopause since 41 years old." The outcome of the events was not recovered. No treatment was given to the patient for the events. Follow up attempts are needed. Further information has been requested.
46 2021-06-01 pain in extremity 48 hrs after receiving the 2nd dose, the patient had nausea and vomiting. Could barely function, fat... Read more
48 hrs after receiving the 2nd dose, the patient had nausea and vomiting. Could barely function, fatigue/bodyaches. Currently, 4 weeks after receiving 2nd dose, the patient has achy hands esp. the left hand- their hands turn black and blue sometimes, not swollen. Her hands hurt but she plays tennis so has been taking advil to manage the pain. Did take anti-inflammatories before receiving the vaccine. We ordered labs for the patient to check for an underlying immune disorder which is flaring up. Advised pt to keep hands warm and to not overuse them and to continue on NSAIDs as needed for pain.
46 2021-06-01 pain in extremity I started having pretty bad pain in the knuckles of my hand, both hands and the wrist. Then I was ha... Read more
I started having pretty bad pain in the knuckles of my hand, both hands and the wrist. Then I was having joint pains in my knees and ankles. So I went to the Dr. arthritis does run in my family so I was thinking my it was starting to kick up. Dr. did bloodwork. Rheumatoid levels were normal. ANA levels were elevated. Dr. said they were not really really high but that they were elevated. She wanted me to see a rheumatologist who can't see me for months. I have days now where its better and days when it is worse. It is not as bad consistently
46 2021-06-01 sciatica, pain in extremity severe shooting pains up both arms, her hands hurt really bad; ANA positive; enlarged parotid glad o... Read more
severe shooting pains up both arms, her hands hurt really bad; ANA positive; enlarged parotid glad on the left side and inflamed parotid glands; enlarged parotid glad on the left side and inflamed parotid glands; sciatica pain of the right side; This is a spontaneous report from a contactable consumer (patient). A 46-year old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8735) via an unspecified route of administration at left arm on 19Apr2021 16:30 (46-year old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history depression, thrombocytopenia, severe IBS, carpal tunnel right extremity, and allergies to Penicillin, Sulfa drugs. Concomitant medications that the patient received within 2 weeks of vaccination included ONDANSETRON. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 29Mar2021 (46-year old at time of vaccination), at single dose, for COVID-19 immunization and experienced "there was a hole inside her left ear/ ear abscess", "thick yellow, clear puss and blood was oozing out of her left ear", "sciatica pain", and "nerve pain". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor Visit 24Apr2021 for sudden onset sciatica pain of the right side this time and got a cortisone injection that helped. CT Scan 25Apr2021 to figure out what is happening in patient's ear and showed enlarged parotid glad on the left side and inflamed parotid glands. Patient has severe shooting pains up both arms, her hands hurt really bad. Doctor visit 27Apr2021 followed up with ENT and he indicated patient needed to see rheumatologist for ANA positive test. Doctor visit 03May2021 Rheumatologist. 09May2021 labwork. Urgent care Doctor visit 14May2021 for severe sciatica pain that continues. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event sciatica and included cortisone injections, deep muscle massage/exercise. The outcome of the events was not recovered.
46 2021-06-01 tremor, weakness, numbness So immediately after the vaccine I felt like I was intoxicated. My head did not feel right. Withi... Read more
So immediately after the vaccine I felt like I was intoxicated. My head did not feel right. Within 6 hours of the vaccine all I wanted to do was sleep. I felt very sick, very fatigue and very weak. I was like that for 11 days. I went to my PCP 11 days after, he tested me for the Epstein Barr virus, and he did bloodwork. The results came back, and that the Epstein Barr virus was activated and my B12 was high elevated. The B12 was in the 1200 range. I went back to Dr. on February 10th. He gave me a steroid shot and B12 shot. I still felt fatigue and weak. I only work 5 days, 3-week frame. On February 17th, I saw another Dr. for headaches and tremors. I was extremely sick. On February 19th, I went to the ER. I went due to having left facial and upper body weakness and numbness. I was also very confused and was having tremors. They thought I was having a stroke. They did a CAT scan that did not show anything, so I had an MRI. I did a follow-up with my neurologist on the 29th of March. My lupus doctor also checked on me every other day. The last time I had any symptoms was the beginning of April.
46 2021-06-02 weakness not feeling well; Headache; Rashes; feel weak; fatigued; Difficulty breathing, short of breath when ... Read more
not feeling well; Headache; Rashes; feel weak; fatigued; Difficulty breathing, short of breath when she walks; Fever; swollen injection in the arm; muscle pain; redness; runny nose; sore throat; nausea; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: 11263) via an unspecified route of administration in left arm on 22May2021 at 14:30 as single dose for COVID-19 immunization. Medical history included known allergies (unspecified). Concomitant medication included in two weeks which included food supplement. Patient did not receive any other vaccine in four weeks. Patient did not had COVID before vaccination and was not tested for COVID post vaccination. Patient previously received first dose of BNT162B2 (Lot number: 11263) in left arm on 01May2021 at 14:15 as single dose for COVID-19 immunisation and experienced headache, rash. On 22May2021 (Saturday), at 16:00, patient experienced swollen injection in the arm, rashes, headache, fever, muscle pain, redness, runny nose, sore throat, nausea, shortness of breath. Reportedly, after second shot patient developed fatigue, fever, rash, headache, felt weak and fatigued and if walks, becomes short of breath and had difficulty breathing. Patient was supposed to go to work but since Monday (24May2021), she could not go to work, because she was not feeling well. States she still has a headache. Due to the events, patient visited doctor or other healthcare professional office/clinic visit. Therapeutic measures taken in response to the event included treatment with Tylenol. Outcome of the events were resolving. Information on Lot/Batch number was available. Additional information has been requested.
46 2021-06-02 breast pain On the day of the vaccine, I felt very tired, fever, muscle pains, headache, and nausea. I did not ... Read more
On the day of the vaccine, I felt very tired, fever, muscle pains, headache, and nausea. I did not take any medication. I improved over 3 days and almost all gone away. About a month after the vaccine, I found a lump in my right breast (self exam during shower). It was bigger and painful. I went to the doctor and referred to specialist. I did a mamogram and ultrasound. I had a 10cm area infected tissue as well as a cyst. I was put on 2 rounds of antibiotics (the only one I can remember is Augmentin). The infection was resolved after I finished the 2nd round of antibiotics (Augmentin) and the size of the cyst is decreasing. As I was recovering from the breast cyst, I started to notice pain in my pelvic area. I went to see NP/PCP and I had a CT scan which showed an ovarian cyst and was referred to a gynecologist. I did lab work and pelvic ultrasound. Right now just monitoring the size and following up periodically.
46 2021-06-02 pain in extremity Pain under armpit & all around arm down to elbow since the vaccine
46 2021-06-02 tingling, pain in extremity, numbness Left arm pain, tingling/numbness ongoing on/off for four months
46 2021-06-03 feeling hot Brain fog; headache; tired; nausea; extremely hot feeling; itchy all over; face tightness; This is a... Read more
Brain fog; headache; tired; nausea; extremely hot feeling; itchy all over; face tightness; This is a spontaneous report from a contactable other HCP (patient reported herself). A 46-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, PFIZER, Solution for injection) via an unspecified route of administration, administered to her left arm on 05Mar2021 02:30 PM (Lot number: EL9267) as single dose for Covid-19 immunisation. The patient's medical history included high blood pressure (BP), chronic obstructive pulmonary disease (COPD) and post-traumatic stress disorder (PTSD). Known allergies: any caine medicine. Facility type vaccine: Public Health Clinic/Veterans Administration facility. Concomitant medications included lisinopril and tramadol (other medications in two weeks). On 05Mar2021 05:30 PM, the patient experienced brain fog, headache, tired, nausea, extremely hot feeling, itchy all over and face tightness. No COVID tested prior or post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
46 2021-06-03 flushing, weakness, numbness, unresponsive to stimuli, tingling, seizure, tremor Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: <5 min post dose patient noted feeling short of breath, numbness, dizzy, sweaty, shaky and then lost consiousness. I was able to catch her head so she didnt hit a hard surface. Patient was unresponsive for 10 seconds. She started to seize and her eyes rolled to the back of her head. After she regained consciousness she was moved into the pharmacy and laid down. Pt was given a cool towel and water.1st BP (112/70 & HR74), 2nd BP 15min later (110/70 & HR 84). After 45 min pt left with family member
46 2021-06-03 numbness It made my arm feel numb; tightness moved to my neck and lower shoulder; This is a spontaneous repor... Read more
It made my arm feel numb; tightness moved to my neck and lower shoulder; This is a spontaneous report received from a contactable consumer, the patient. A 46-year-old non-pregnant-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208 or EW6208) via an unspecified route of administration in her left arm on 12March2021 at 13:45 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included only seasonal allergies and had no other medical history. The patient had no Allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. She did not receive any other medications within 02 weeks of vaccination. On 12Mar2021 at 13:45, the patient could feel the vaccine moving down in her arm which made her to felt numbness in the arm and it came to her wrist then travelled back up to her underside of arm into the shoulder. Then, the numbness and tightness moved to her neck and lower shoulder. It eventually made its way to her chin and bra strap area. At that point, she took a Benadryl as a treatment for of the events. Within 15 to 20 minutes after having the Benadryl, her numbness was stopped. The clinical outcome of the event numbness in arm was resolved on 12Mar2021, however the outcome of the event tightness moved to her neck and lower shoulder was unknown. No follow-up attempts are needed. No further information is expected.
46 2021-06-03 pain in extremity Arm soreness; 2 small itchy spots about the size of a flea bite or smaller on neck about two hours a... Read more
Arm soreness; 2 small itchy spots about the size of a flea bite or smaller on neck about two hours after and a larger sized itchy bite like spot on other side of neck about 8 hours later; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the right arm on 15Mar2021 at 12:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included anemia, psoriasis, high cholesterol, dust allergy. Concomitant medications included vitamins. Allergies to medications, food, or other product reported as sensitive skin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 14:00, the patient experienced itchy rash (two small itchy spots about the size of a flea bite or smaller on neck about 2 hours later, and a larger sized itchy bite like spot on other side of neck about 8 hours later) and painful arm at 18:00. The patient did not receive treatment for the reported events. The clinical outcome of painful arm and of the itchy rash was recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected
46 2021-06-04 numbness Numbness feeling on left side of body; sharp pain in jaw; This is a spontaneous report from a contac... Read more
Numbness feeling on left side of body; sharp pain in jaw; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: En8201), dose 1 via an unspecified route of administration, administered on Arm Left on 25Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, on 25Feb2021, The patient experienced numbness feeling on left side of body, sharp pain in jaw. No treatment was received for the events. The outcome of events was "recovered".
46 2021-06-05 numbness, tingling Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)... Read more
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
46 2021-06-05 muscle spasms Miscarriage. Had first vaccine dose about 2 weeks after a positive home pregnancy test (on 04/24/202... Read more
Miscarriage. Had first vaccine dose about 2 weeks after a positive home pregnancy test (on 04/24/2021). Date of last period was 03/19/2021. No fertility treatments. Spontaneous pregnancy at 46 years old. Had 2 previous miscarriages - 6 months earlier and 3 years earlier. Started bleeding and cramping 05/26/2021. Went to emergency room. They checked with ultrasound and said it was probably a miscarriage. The baby should be 9 or 10 weeks, but the ultrasound showed it was much too small for that - probably stopped developing at about 6 weeks. Pregnancy hormone levels were normal, however. Followed up with OBGYN the next day - she confirmed it looked like a miscarriage. The cramping/bleeding lasted for another week. Follow-up appointment on 06/04/2021 showed the uterus had completely emptied.
46 2021-06-06 weakness Starting around 11:50pm, lying down falling asleep when onset of sudden rapid heart rate, presyncope... Read more
Starting around 11:50pm, lying down falling asleep when onset of sudden rapid heart rate, presyncope repeated occurred for several hours. Weakness, dizziness, feelings of passing out. Would pass and then start again. Heart rate reached around 139 bpm at its highest while lying flat with legs elevated. Became milder over several hours and ended by around 2:45am. Tired, headache, lightheaded the following day but no more rapid heart or presyncope.
46 2021-06-07 weakness I began a very heavy and long menstrual period after receiving my second dose of the COVID-19 vaccin... Read more
I began a very heavy and long menstrual period after receiving my second dose of the COVID-19 vaccination. I began bleeding 4/7/2021 and didn't stop until 3 weeks after my endometrial ablation. The ablation was completed 5/11/2021 and the bleeding didn't stop completely until 6/2/2021. I had multiple CBC tests performed during this period of time and my HGB levels plummeted from 12.6 on 4/13/2021 to 8.4 on 5/14/2021. RBC count went from 4.48 on 4/13/2021 to 3.10 on 5/14/2021. I experienced severe anemia, was incredibly weak, missed multiple days of work, and required surgery to finally stop the bleeding.
46 2021-06-07 weakness Tired, lethargic and weak for 10 days
46 2021-06-07 pain in extremity Sore arm; fatigue; tiredness; This is a spontaneous report from a contactable pharmacist reported fo... Read more
Sore arm; fatigue; tiredness; This is a spontaneous report from a contactable pharmacist reported for herself . A 46-years-old female non pregnant patient received bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, in Arm Left on 27Feb2021 as 1ST DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID, prior to vaccination. The patient did not test for COVID, post vaccination. It was reported that on 01Mar2021, she had sore arm, fatigue and tiredness. Treatment was received for adverse events. Therapeutic measures were taken Tylenol as a result of sore arm (pain in extremity), fatigue, tiredness. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-06-07 seizure Starting 2 days post vaccine she experienced a series of mild seizures and headaches/dizziness. Her ... Read more
Starting 2 days post vaccine she experienced a series of mild seizures and headaches/dizziness. Her provider temporarily increased her dose Topamax which led to improvement of symptoms.
46 2021-06-08 inability to speak, tremor Pt received second dose of vaccine and within 10 minutes had SOB, audible wheezing, and difficulty s... Read more
Pt received second dose of vaccine and within 10 minutes had SOB, audible wheezing, and difficulty speaking. Pt self administered one dose of Epipen (had own pen present from home) and noticed short term relief of symptoms. Within 10 minutes, pt had worsening wheezing, difficulty speaking, and tremors. Pt self administered 2 inhalations of Proair that she had present from home. EMS was called at this time, and pt was transferred to ED upon arrival.
46 2021-06-08 weakness body ache; headache; non-stop vomiting; Fever; weak; This is a spontaneous report from a contactable... Read more
body ache; headache; non-stop vomiting; Fever; weak; This is a spontaneous report from a contactable consumer (patient) via Medical information team and Pfizer sponsored program. A 46-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729, NDC number/Expiry date: Unknown) via an unspecified route of administration in the left arm on 21Apr2021 03:40 PM, as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 as single dose for COVID-19 immunisation. It was reported that after 12 hours of vaccination (conservatively took 22Apr2021), the patient had a body ache. Twelve hours after the second dose symptoms showed up. She developed body aches, headaches, fever, and non-stop vomiting. On 22Apr2021 at 04:00 AM in the morning, the patient experienced headache and fever and in the afternoon non-stop vomiting. The patient stated that due to her side effects she had to go to the emergency room and they gave her a lot of things, but she did not know what they were. The patient was there in the emergency room for 5-6 hours and underwent lab tests which included blood test and X-Ray and the results were obtained as normal. She was verbally told that everything was fine. There were no concerns about the tests. The patient also stated that because of emergency room visit she had a 2400 dollar bill. She would like to know if there was any program for assistance in paying for her medical bills. Response received as a federal program that had been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. It was reported that by the time she left the emergency room she left on two feet, but was weak but okay, she had no pain or fever, had a little temperature not a fever. On Apr2021, the outcome of the events (reported as around 36 hour, early in the morning the patient felt fine and well) body ache, fever, non-stop vomiting and headache were recovered on an unspecified date. The outcome of the weak was unknown. No follow-up attempts are needed. No further information is expected.
46 2021-06-08 slurring The first event started on 4/22/21. I go into an altered state where I can?t stay awake and I go in... Read more
The first event started on 4/22/21. I go into an altered state where I can?t stay awake and I go into kind of a blackout that lasts for hours. I?ve been hospitalized twice, discharged on 6/2/21. My blood pressure is dropping sometimes which has made me pass out. I have slurred speech also during these episodes.
46 2021-06-08 nerve pain, tingling, burning sensation Immediate onset of burning nerve pain with pins and needles sensation in upper right side of face
46 2021-06-08 pain in extremity her left leg where she had the hives and rash; bumps; pimples; Itchy all over her body; her right si... Read more
her left leg where she had the hives and rash; bumps; pimples; Itchy all over her body; her right side was painful from her shoulder, back, and scapula area on the right side all the way to her arm; her right side was painful from her shoulder, back, and scapula area on the right side all the way to her arm; her right side was painful from her shoulder, back, and scapula area on the right side all the way to her arm; Started breaking out in hives on one leg only; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Expiration Date: unknown), via an unspecified route of administration, administered in arm left on 24May2021 at 13:00 (Batch/Loat Number: EW0187) as 1st dose, single dose for covid-19 immunization.Medical history included asthma (she had asthma as a child).Concomitant medication included cortisone taken for an unspecified indication.The patient did not receive any other vaccines prior to the COVID vaccine. The patient didn't had adverse event prior vaccinations.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25May2021 (Tuesday )morning at around 20:00 to 21:00, the patient started feeling itchy all over her body and at around 22:00 she started breaking out in hives on one leg only. It was only in one spot and Tuesday evening her whole leg had over 10 hives. On 26May2021, the next day the patient did not know if it was because of her itching, but the hives turned bumpy. She still has the marks there. It has been a week now. It was very itchy, she went to the doctor this weekend and had bloodwork, and she was waiting on the results. She was not sure if she was able to take the second vaccine. She got the vaccine in her left arm and had a reaction on her left leg. Also, that Tuesday morning, her right side was painful from her shoulder, back, and scapula area on the right side all the way to her arm. It is not when she moves it, it was just painful for a couple of days there. The hives and bumps are starting to go away, but she is still very itchy. She took Cortisone, Benadryl, and Claritin. The Benadryl she got off the shelf, and the Cortisone and Claritin were prescribed. She has no NDC, lot, or expiration date available for the Cortisone, Benadryl, or Claritin that she took. It was only on the left side that she broke out with hives and pimples. Her body and skin feel itchy all over, but it was only her left leg where she had the hives and rash. The hives and bumpy rash are starting to go away. She can tell it was starting to go away. Her right arm was painful all the way from her shoulder and upper back to her arm. It was not painful when she moved it, it was more just pain. It got better, Tylenol helped. She would say it lasted 2 or 3 days then it subsided. The patient took the vaccine because of her kids were pressuring her. She didn't want to get it, but it was family pressure. The patient was not hospitalized. The patient was visited physician office. Patient lab test included: She was tested for allergies and had a CBC on 29May2021 (Saturday) results were not back yet. The outcome of the event itchy all over her body was not resolved, the outcome of the events started breaking out in hives on one leg only, hives on leg turned bumpy, bumps were resolving, outcome of the event her right side was painful from her shoulder, back, and scapula area on the right side all the way to her arm resolved in May2021 and the outcome of the event her left leg where she had the hives, rash and pimples were unknown. Information on the lot/ batch number has been requested.
46 2021-06-08 tingling When I received my vaccine, I waited 15 minutes at pharmacy and didn't notice any adverse symptoms. ... Read more
When I received my vaccine, I waited 15 minutes at pharmacy and didn't notice any adverse symptoms. But around 4:00 pm, I stood up and noticed that my knees were swollen, popping and cracking when I walked. I have never had any problems with my knees, and exercise regularly, so at first I thought is was just a weird Covid side affect...but I couldn't find that particular symptom on the list of Covid vaccine side effects. I took 2 Alleve and applied Arnica Gel to my knees. A couple hours later, my fingers, hands and wrists felt swollen. Then overnight, I noticed that I started to feel itchy, tingly in random spots all over my body. But I did not develop a rash. The next morning, my face was swollen, my throat felt sore/tight, everything felt puffy and swollen. My daughter asked me if I got Botox because "my wrinkles were gone"!! That's when I knew it was an allergic reaction. I took 2 Benedryls and just napped all day. I continued taking Benedryl for 2 days, and eventually the symptoms went away. Other than swelling, I only had mild muscle pain at the injection site. No fever or muscle pain, just swelling and the tingly itchiness all over. However, the joint discomfort in my knees and hands is still there.
46 2021-06-09 migraine rash formed under injection site with burning/itching; rash formed under injection site with burning... Read more
rash formed under injection site with burning/itching; rash formed under injection site with burning/itching; rash formed under injection site with burning/itching; dizziness; nausea; migraine; fever; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21May2021 10:00 (at the age of 46-year-old) (Batch/Lot Number: EW0182) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient was not pregnant at the time of vaccination. Medical history included known allergies to Septra, Cipro, Erthamycin, Lexipro, protonix, strawberries and house dust. The patient had no other medical history. Concomitant medications included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN) and multivitamin. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0123) on 30Apr2021 at 10:00 AM (at the age of 46-year-old) for COVID-19 immunisation. On 21May2021, the patient experienced fever, chills, and body aches 8 hours after 2nd shot. On 23May2021 at 10:00 AM, the patient experienced rash formed under injection site with burning/itching, dizziness, nausea, and migraine began 48 hours after the injection. The events required doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all events which included Benadryl, Tylenol, and ice. The patient was recovering from all events. Follow-up attempts are needed. Further information is expected.
46 2021-06-10 flushing presyncope, flushing, tachycardia with self resolution within 5 minutes.
46 2021-06-10 hot flush That SUnday Feb the 7th of 2021 during the night I experienced nausea and diarrhea. That Monday the ... Read more
That SUnday Feb the 7th of 2021 during the night I experienced nausea and diarrhea. That Monday the 8th I was still feeling nausea and feeling hot flashes like I was going to pass out. I ran outside because I didn't want to pass out in the house alone so I had run outside. I did not know what was going on it was out of nowhere. On Feb the 10th 2021 I went back to work and around 7am I developed a sharp pain on my left side so I went to the ER and they ran tests and said a UTI and possibly a cyst. From 2/10/21 to the rest of the month I was in excruciating pain and had a CAT scan of my abdomen. My DRs sent me to the OBGYN and they said it wasn't the cyst. My DR said maybe it's the reason why I was having the GI problems. I got a EG test and a colonoscopy. They said I had organs displaced on the side but that would not cause all these issues. I went to the ER again and they treated me for UTI. Finally I was not satisfied with the results I was getting so I saw DR. I got ultrasound of my Kidney and they still couldn't see what was wrong. On March 12 2021 around 3AM I woke up in excruciating pain and ambulance came and brought me to the hospital and I went to the ER again and they called the on call OB and they wanted to do surgery and they said I was bleeding internally all this time. My left ovary was bleeding and they had to remove my ovary. I had that left ovary removed on March 12 2021. This has never been an issue before. I am now in physical therapy but I am not really recovered.
46 2021-06-10 migraine Meningitis type symptoms; Severe swelling on right side neck, shoulders, arms; Severe swelling on ri... Read more
Meningitis type symptoms; Severe swelling on right side neck, shoulders, arms; Severe swelling on right side neck, shoulders, arms; Severe swelling on right side neck, shoulders, arms; Four episodes of migraines; Vomiting with Migraines; Rash on right side; Tired; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0168 and expiration date was not reported), via an unspecified route of administration, administered in arm right on 11May2021 (at the age of 46 years old) as single dose for covid-19 immunization. The patient medical history and family medical history relevant to adverse events was none and concomitant medications were not reported. Previously, patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number: ER8735 and expiration date was not reported), via an unspecified route of administration, administered in arm right on 20Apr2021 15.35 as single dose for covid-19 immunization at Pharmacy. The patient had no adverse events following prior vaccinations. No prior vaccinations (within 4 weeks) and no additional vaccines administered on same date of the Pfizer Suspect. No other products were given. On 12May2021, the patient had flu like symptoms. On 13May2021, the patient was tired. On 14May2021, the patient had rash on right side. On 16May2021, the patient had severe swelling on right side neck, shoulders, arms. The patient had a total of four episodes of migraines with vomiting since the first one on 16May2021. The patient stated that the migraines and vomiting were persisting; but mentioned that she had not had an occurrence since 30May2021 (this past Sunday). She wanted to make sure it was notated in the report that she had an appointment with an Immunologist on 08Jun2021 (Tuesday) and with a neurologist on 16Jun2021. The patient had a severe adverse reaction that resulted in two emergency room and one urgent care visits. One of the doctors reported it to her about local Department of Health and Environmental Control (DHEC); they called her and said she needed to call and report it to Pfizer. Emergency room and physician office visit was done for severe swelling on right side neck, shoulders, arms; migraine; vomiting with migraines. On unspecified dates, the patient had for meningitis type symptoms. The patient denied any medications or medical conditions relevant to events. The patient underwent lab tests and procedures which included Computerized tomogram (CT) scan with result as nothing abnormal, no blood clots on unspecified date. The outcome for meningitis type symptoms was unknown, for severe swelling on right side neck was not recovered, for severe swelling on shoulders was not recovered, for severe swelling on was not recovered, for rash on right side was recovering, for migraine was not recovered, for vomiting with migraines was not recovered, for flu like symptoms was recovered on 13May2021, for tired was recovered on 15May2021. Follow-up attempts are completed. No further information is expected.
46 2021-06-11 tingling, numbness Even 1 month later inject site is still very sore. Left hand and arm gets pins and needles feeling s... Read more
Even 1 month later inject site is still very sore. Left hand and arm gets pins and needles feeling several times throughout the day which sometimes leads to numbness.
46 2021-06-12 pain in extremity Left arm pain and swelling for 3 days. Started to have shortness of breath, mild wheezing for few mi... Read more
Left arm pain and swelling for 3 days. Started to have shortness of breath, mild wheezing for few mins then subsides. The shortness of breath and mild wheezing occurring few mins once or twice a day occurred 3-5 times since getting the Pfizer vaccine.
46 2021-06-13 burning sensation Burning sensation. Very red & raised rash and hives began to develop, particularly on arms
46 2021-06-13 discomfort Pt returned to clinic approx. 1.5h after vaccination reporting that her tongue feels heavy and her t... Read more
Pt returned to clinic approx. 1.5h after vaccination reporting that her tongue feels heavy and her throat feels like it's closing. Pt appeared in no acute distress- speech clear, VSS (BP 120/75, HR 73, O2 100%). 10ml PO benadryl administered. Pt observed for additional 15 minutes and reported that she felt "much better". Pt advised to see PCP.
46 2021-06-13 pain in extremity 11 Hours after injection had 102 degree fever and chills, Slightly sore arm, swollen lymph nodes in ... Read more
11 Hours after injection had 102 degree fever and chills, Slightly sore arm, swollen lymph nodes in left armpit and left side of neck for 3 days. Swollen lymph nodes near left collar bone for 5 weeks. It was the size of a large pea. Developed an asthmatic cough and allergies heightened with nasal drip and itchy eyes.
46 2021-06-14 hot flush Pt reports the same night as her vaccination (which was her second dose of COVID vaccine) she threw ... Read more
Pt reports the same night as her vaccination (which was her second dose of COVID vaccine) she threw up all night long, experienced fatigue, sweats, chills, hot flashes, HAs, brain fog, severe dizziness, diarrhea, coughing, congestion, THROAT SWELLING, AND DIFFICULTY SWALLOWING. No SOB or tongue or lip swelling. She says that her symptoms have been improving over the last 4 days, but that her throat swelling is still present. She had a negative exam and SpO2 95%. Advised her to avoid any COVID vaccines in the future unless she has seen an allergist and they have cleared her to receive subsequent COVID vaccines. Prescribed her Prednisone 40mg Once daily x 5 days for suspected allergic reaction. OF INTERESTING NOTE: PT REPORTED THIS AS HER SECOND DOSE OF THE VACCINE, BUT UPON FURTHER RESEARCH, ACCORDING TO THE SYSTEM , THE DOSE SHE REC'D ON 6/10/21 WAS HER 4TH DOSE OF PFIZER COVID VACCINE. THAT IS NOT A TYPO. SHE HAS RECORDS FOR 4 DIFFERENT VACCINATIONS OF THE PFIZER COVID VACCINE THAT DO NOT SEEM TO BE DUPLICATED INFORMATION.
46 2021-06-14 pain in extremity, numbness Right leg and right foot have been numb for one week. Arms are numb sometimes but not continuously. ... Read more
Right leg and right foot have been numb for one week. Arms are numb sometimes but not continuously. Sore arm. Sore belly. Right ear hurts inside. Lymph nodes on neck hurt. Headaches.
46 2021-06-14 trigeminal neuralgia I've managed my Trigeminal Neuralgia without any pharmaceutical medication for over a year & half wi... Read more
I've managed my Trigeminal Neuralgia without any pharmaceutical medication for over a year & half with medical marijuana. After my first vaccine shot I started having intense random flare ups. After my second shot my flares up were incredibly intense & were all day long.
46 2021-06-15 flushing Remained in vaccine clinic for 30 minute observation period after vaccine administration. 15 minute... Read more
Remained in vaccine clinic for 30 minute observation period after vaccine administration. 15 minutes after leaving clinic (45 minutes after vaccine administration), experienced flushing across chest, dizziness and nausea. These symptoms persisted for two days and were significant enough that patient stayed in bed some of that time. Patient reports no vomiting/diarrhea, no swelling, no respiratory issues. She did not seek medical attention while experiencing the symptoms. She reports she later consulted with her PCP about whether she should receive her second dose of Pfizer COVID vaccine. She reports her doctor had reservations, but she was determined to get fully vaccinated, so her PCP renewed her epi pen prescription. As of this writing, the patient has not yet received another dose of COVID vaccine.
46 2021-06-15 migraine Migraine headache; extreme fatigue/ tiredness; muscle ache; pain; This is a spontaneous report from ... Read more
Migraine headache; extreme fatigue/ tiredness; muscle ache; pain; This is a spontaneous report from a contactable Physician (patient). A 46-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Left on 23Feb2021 09:45 (Lot number was not reported) as single dose for covid-19 immunisation (at age of 46-year-old). Medical history included hypothyroidism, Migraine headaches, allergy to sulfa. Concomitant medications in two weeks included levothyroxine sodium (LEVOXYL); erenumab aooe (AIMOVIG). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021 03:00 patient experienced migraine headache, extreme fatigue and tiredness, muscle ache and pain. No treatment was received. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient recovered from the events. No Follow-up attempts are possible. Information about lot/batch number cannot be obtained.
46 2021-06-15 pain in extremity Unusual, large swelling in both feet and lower legs within 3 hours of vaccination. Swelling was so i... Read more
Unusual, large swelling in both feet and lower legs within 3 hours of vaccination. Swelling was so intense in feet it bordered on painful.; Swelling was so intense in feet it bordered on painful.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Mar2021 19:30 (Lot Number: En6208) (at the age of 46-years-old) as 1st dose, single dose for covid-19 immunization. Medical history included hyperlipidaemia, high triglycerides, obesity, asthma and atopic dermatitis all from an unknown date and unknown if ongoing. The patient had known allergies for shellfish and latex. The patient did not receive other vaccines in four weeks. Concomitant medications included omega-3-acid ethyl ester (LOVAZA), rosuvastatin calcium (CRESTOR), vitamin d NOS and levocetirizine dihydrochloride (XYZAL), all taken for an unspecified indication, start and stop date were not reported. The patient experienced unusual, large swelling in both feet and lower legs within 3 hours of vaccination on 12Mar2021 at 22:30. Swelling was so intense in feet it bordered on painful. The patient had no Covid prior to vaccination and had not been tested for COVID post vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected
46 2021-06-16 pain in extremity About 2-3 days after my second COVID-19 Pfizer vaccine shot, the middle finger of my right had began... Read more
About 2-3 days after my second COVID-19 Pfizer vaccine shot, the middle finger of my right had began to swell, turn slightly purple, and become painful, and this pain and swelling worsened as the week progressed. I also experienced unusual redness and itching on both my hands, especially the palms and writsts, but this has been only mild, and occasional. The pain in my fingers, however, seems to wax and wane, sometimes spreading to my pointer finger and most of my third finger, and other times receding just to the top inch or two of my middle finger. Everything I do with my hand--write, type, wash, etc.--has been hampered by the pain and swelling, and the discomfort has occasionally kept me awake at night. It has now been about a week since this symptom became noticeable. It is slightly less painful than it was in the first 2-3 after the onset of symptoms, and the swelling is mainly restricted to the top inch of my middle finger (approximately up to the first joint) but it is still painful enough to hamper my everyday life. I hope and pray sincerely that it will resolve soon.
46 2021-06-16 pain in extremity It was basically tapering off and then like it kind of continue to taper off for 2 more days and the... Read more
It was basically tapering off and then like it kind of continue to taper off for 2 more days and then it kind of took break; My shot hurt a little bit for the first day and maybe like second day; I had my arm really really hurt; Joint pain/my hip and my knee hurt; This a spontaneous report received from contactable consumer (patient) or other non HCP A 46-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0171), via an unspecified route on 30Apr2021 in the right arm (at the age of 46-years) as 1st dose, single dose for covid-19 immunisation. The patient medical history included allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), multi Vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date, the patient experienced basically tapering off and then like it kind of continue to taper off for 2 more days and then it kind of took break and almost felt like it restarted cycle all over again; it is like super crazy heavy; it is still continuing to be really heavy flow, joint pain, her shot hurt a little bit for the first day and maybe like second day; patient had arm really hurt and had hip and knee hurt. Patient feel like how much blood loss it is. Patient stated that she wasn't really fully tracking or aware of it after the first dose but something did happen where she remember it being a little heavier and a little longer but not as extreme as it has been after the second dose. Patient stated that from the past 2 days, like she said it's like very heavy flow and also like major cramping, so she took Tylenol 500 milligrams. The outcome of the events was unknown. Follow up needed, further information has been requested.
46 2021-06-17 muscle spasms Muscle weakness and spasms to the point of not being able to walk for the evening of inoculation and... Read more
Muscle weakness and spasms to the point of not being able to walk for the evening of inoculation and the following 2 days. Ongoing extreme stiffness and significantly reduced range of motion. Inability to stand or walk for long periods of time. In addition had considerable muscle pain that seemed to move throughout the body the evening of the vaccination and the subsequent 2 days. Note: After first vaccination had muscle weakness and stiffness beginning the evening of the vaccine though significantly less.
46 2021-06-17 pain in extremity For a few days after the 2nd dose I had the normal arm ache, after one day of no symptoms my whole l... Read more
For a few days after the 2nd dose I had the normal arm ache, after one day of no symptoms my whole left arm from my shoulder to my elbow, it really hurt, it was like a very deep ache. Then it went away and about 3 weeks later my left knee started feeling kind of weak, I could not put any weight on it and it got progressively worse. It started getting swollen like 3 times bigger than my other knee, it was very painful. It was limited to my left knee but a few times at night my whole tight had that same kind of ache as in my arm, like a very deep ache and it was so painful it would wake me up at night. I had a hard time going back to sleep. That lasted about 2 or 3 nights. That thigh ache went away so now I just have the swollen knee. Around 06/06/2021 I went to get an x-ray so I must have called my doctor about 2 days before that. After that I was told to go to the ER and they just gave me crutches and prescribed some anti-inflammatory medicine, then a few days after I went to the ER again and they kept me overnight and they removed fluid and they tested it and they are still doing testing, they gave me a different anti-inflammatory medicine and told me to stop taking the first one.
46 2021-06-19 numbness About three weeks after the last vaccination which was done on March 4, 2021, I started noticing som... Read more
About three weeks after the last vaccination which was done on March 4, 2021, I started noticing some numbness in my fingers that has progressively gotten worse and was intermittent for a week and now constant in varying degrees all the time.
46 2021-06-20 pain in extremity Fatigue, Fever. Erythema at injection site, Injection site pain, Swelling at injection site. Requir... Read more
Fatigue, Fever. Erythema at injection site, Injection site pain, Swelling at injection site. Requires emergency room visit or hospitalization. Dizziness, headache, shortness of breath, myalgia. Diarrhea, nausea. Requires ER visit or hospitalization. ED visit. Needs further determination of action for next dose. Patient states she had her first dose of the Pfizer vaccine yesterday afternoon around 12:30 PM. She states initially she felt okay and about an hour after getting home she started feeling nauseous and dizzy with standing and walking around. She states later in the evening she started feeling increasingly short of breath with minimal activities and at times feeling like it is hard to get a deep breath then. She denies any feelings of throat swelling or tongue swelling. She was always able to handle her secretions. She has been feeling nauseous but denies any vomiting. She had 3 episodes of watery diarrhea yesterday and decreased appetite. She does not believe she ever had COVID-19 and denies any recent ill contacts or known exposure. She denies any complaints of chest pain but does admit to feelings of palpitations at times yesterday. She has a pulse oximeter that she was able to check her heart rate at home and states that her pulse ox was always okay and heart rate was around 80s at home. She does currently admit to mild nausea and aching in her right arm. She denies dizziness while lying in bed but states she feels like it would be harder for her to get up and walk around. She has had previous allergic reactions to antibiotics but denies any history of throat swelling or anaphylaxis. States her right arm looked red and has a burning sensation around the injection site but never noticed any rash or hives otherwise. She took Tylenol and Motrin over-the-counter yesterday with some temporary improvement in the arm pain and headache that she was experiencing yesterday but has not yet taken any Tylenol or Motrin today. She denies current headache.
46 2021-06-20 tingling Day 1- craving for food, sleepy Day 2-3 body aches, fatigued Day 4 - now , pins and needles sensati... Read more
Day 1- craving for food, sleepy Day 2-3 body aches, fatigued Day 4 - now , pins and needles sensations, too fatigued to do many everyday activities, lighthearted, Day 13-14, chest pain, shortness of breath, fainting, sent to ER twice and hospitalized
46 2021-06-21 weakness, speech disorder, migraine with aura, severe one side paralysis, facial paralysis 4/6 woke w/bad headache, dizzy, r. side paralysis, dragging r. leg, had difficulty w/speech. Called ... Read more
4/6 woke w/bad headache, dizzy, r. side paralysis, dragging r. leg, had difficulty w/speech. Called 911, went to ER via squad w/stroke like symptoms. Tests, no sign of stroke, no known cause, ok to go home. 4/22 paralysis symptoms recurring, called 911, ER via squad, stroke like symptoms. R. side paralysis, tests no stroke, admitted, no knowm cause, referred to nuerology, ok to go home. 4/29 seen by nuerologist, no known of cause, treated for migraine w/o pain, trans. neuro. defecit. Intractable migr.w/aura w/status migranosus. Ongoing/continued episodes, r.side paralysis. 4/30 2nd dose COVID vaccine. 5/14 episode started in AM, cont. on/off, started around 2pm, r.side paralysis, facial droop, cont. 5 days perm weak
46 2021-06-21 muscle spasms, breast pain, migraine -Recurrence of IBS symptoms. Had not had in over 20 years. Lasted about three weeks. -Severe body pa... Read more
-Recurrence of IBS symptoms. Had not had in over 20 years. Lasted about three weeks. -Severe body pains. Have lessened -Migraines. Ongoing; periodic. -Dizziness. Has lessened. -Joint pain. Has lessened. -Heart Palpitations. Ongoing. Periodic. -Mood affected. Ongoing. Periodic. -Ovary pain. Ongoing. Periodic. -Breast pain. Ongoing. Periodic. -Muscle spasms. Have lessened. -Worsened tinnitus. Ongoing. -Chest wall soreness. Has lessened.
46 2021-06-22 limb paralysis, severe one side paralysis Continual daily joint pain / immobility / paralysis on opposite side of body as injection, starting ... Read more
Continual daily joint pain / immobility / paralysis on opposite side of body as injection, starting day after injection and continuing for six weeks so far. Joint pain / immobility / paralysis is sporadic and can be knee, ankle, hip, on any given day and a different joint the next day. Always right side. Usually leg / lower body. As serious as complete inability to move joints or put weight on them.
46 2021-06-22 pain in extremity, tremor, involuntary muscle movements, tingling, muscle spasms Extreme muscle fatigue when walking; Weakness in left leg; Frequent muscle spasms; tremors; stabbing... Read more
Extreme muscle fatigue when walking; Weakness in left leg; Frequent muscle spasms; tremors; stabbing muscle pain; "pins and needles" all over body; chest tightness; heart palpitations; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Sharp, stabbing pain in legs; Thousands of fasciculations in all parts of the body, except for the head; inability to sleep; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 10Apr2021 at 14:30, at patient age of 46-year-old, as single dose (Lot number EW0158) for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included vestibular migraines, hypothyroidism. The patient's known allergies included multiple environmental allergies, but nor drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included levothyroxine sodium (SYNTROID) for hypothyroidism, sertraline hydrochloride (ZOLOFT) for vestibular migraine. The patient experienced the adverse events from 11Apr2021 at 02:15 AM. Symptoms started 12 hours after vaccine, 2:15 at night with sharp, stabbing pain in legs. Thousands of fasciculations in all parts of the body, except for the head. During the day: extreme muscle fatigue when walking, weakness in left leg, frequent muscle spasms, tremors, stabbing muscle pain, "pins and needles" all over body, heart palpitations and chest tightness, tremors upon waking up. 7 weeks later, myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk." Heart palpitations are still very strong, inability to sleep - being awaken by the muscle "jerks" numerous times per night. Blood work and MRI of the spine are normal in Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Clonazepam (CLONOPIN) was prescribed with little effect. The outcome of the events was not resolved. COVID was not tested post vaccination.
46 2021-06-23 burning sensation, numbness Burning sensation in body, tenitis in left ear, right ear side numb and stress
46 2021-06-24 cold sweat Pt reported dizziness/. BP 8548. wet & clammy. waited 30 minutes to leave, no dizziness or clammy B... Read more
Pt reported dizziness/. BP 8548. wet & clammy. waited 30 minutes to leave, no dizziness or clammy BP 104/66 hr80
46 2021-06-24 pain in extremity First Dose: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 46-year-... Read more
First Dose: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0175) via an unspecified route of administration in left arm on 04May2021 as 1st dose, single for COVID-19 immunization. Medical history included allergies. Concomitant medication included unspecified allergy pill, but does not really have to take if she was wearing a mask and because she was not going out as much. On 04May2021, patient experienced only sore arm if she touched it. Patient reported that she would not have even known that her arm was sore if she had not touched it. Patient was taking Pfizer Covid-19 Vaccine to preventing coronavirus and to protect herself. It was reported that patient received second dose of Pfizer vaccine on 25May2021 (Lot Number: EW0186) in left arm and experienced left leg felt weird, Joint pain, Back pain, Foot was swollen and painful. Patient reported that with the second dose of the Covid-19 vaccine, she did not have any soreness at the injection site. Patient underwent lab test after second dose for an ultrasound to check for a blood clot but did not find anything. Patient reported that she was diagnosed with tenosynovitis, inflammation of the tendon or sheath around the tendon after the second dose. The outcome of the event was recovered on 05May2021. Information on Lot/Batch number was available. Additional information has been requested.
46 2021-06-24 paralysis, tremor All 5 of us have ongoing pathogen, some with severe SOB ongoing loss of taste and smell. and had som... Read more
All 5 of us have ongoing pathogen, some with severe SOB ongoing loss of taste and smell. and had some symptoms on covid of flu dose #1; loss of smell; fatigue; all symptoms of covid returned; Nausea; vomiting; diarrhea; COVID-induced POTS, no suspected; Hypercholesterolemia; paralysis; All 5 of us have ongoing pathogen, some with severe SOB ongoing loss of taste and smell/increasing SOB; Headache; upper respiratory symptom; chest pain; tightness; leg swelling; dizziness; extremity shaking; This is a spontaneous report from a contactable consumer. A 46-years-old female patient received First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9261),via intramuscular on 05Feb2021 10:20 (at the age of 46 years old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Shingles 2x in Mar2016 & again 2017 after vaccine ,ongoing Treatment include Lyrica via oral route from 2016 ,Mono-epstein barr from unspecified date in Feb2020 to unspecified date in Aug2020 and covid-19 on 29Oct2020.Concomitant medications include Ibuprofen 800mg 3x/day for EVLT From Oct2019 to Apr2021,Progesterone from unknown date ,unknown if ongoing .Historical vaccine include Flu 10/20 Shoot before Covid on unspecified date in Oct2020. It was stated that father contracted covid for first time Dx on 10Mar2021. All his four children contracted it felty from his sibling brother. All five of us those ongoing fatigue, some with severe S.B, ongoing loss of taste & smell. All had same symptoms of covid after dose one. One sibling is resistant to vaccine based upon our reactions to vaccine. On 05Feb2021 After the vaccination of first dose the patient experienced Headache, upper respiratory, then increasing SOB(medically Significant), chest pain, tightness, then leg swelling, then onset of new symptoms of dizziness, paralysis(disability/medically Significant) and extremity shaking. On 17Feb2021, the patient experienced nausea and vomiting. Very sudden onset symptoms to 15Feb2021 but had to go to ER as SOB, had a PE after vaccine, had nature of covid but had all resolved after 1st dose. Will continue, no SOB, very little figure, 98%-99%c resolved. After shoot on 15Feb2021, had sudden diarrhea/SOB ponanysis. After taking a at school on 15Feb2021, ER after sudden onset, held the POTS, covid-induced POTS, no suspected. MCAS at 8 AM, excreted (adblosus disease. Hypercholesterolemia). Also, led to know after secure. We Appetited many food since vaccine. Seriousness criteria important medical event include hospitalization/prolongation of hosp, persistent/significant disability/incapacity. AE required visit to emergency room. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 16Jun2020, sars-cov-2 test positive on 29Oct2020, computerised tomogram pe ruled out on 17Feb2021, electrocardiogram stroke ruled out on 19Feb2021 and magnetic resonance imaging stroke ruled out on 19Feb2021. Treatment was received for events. Outcome of the events All 5 of us have ongoing pathogen, some with severe SOB ongoing loss of taste and smell. and had some symptoms on covid of flu dose 1, loss of smell, diarrhea, covid-induced POTS, no suspected, hypercholesterolemia and all symptoms of covid returned was unknown. Outcome of the other events was recovering.
46 2021-06-25 nerve pain, muscle spasms Within 15 minutes extremely sharp pain up shoulder to back of neck, generalized sick feeling, 5 days... Read more
Within 15 minutes extremely sharp pain up shoulder to back of neck, generalized sick feeling, 5 days after diarrhea, nausea, headache for 7 days, 9 days calf cramp in right leg with red spot in same spot, 2 days later nerve pain started then a week later nerve pain started in left leg. It?s been 2-1/2 month still nerve pain in both legs, joint swelling and muscle spasms. 2-ER visits, Urgent Care visit, Dr visit, x-rays-cervical and lumbar, leg ultrasound, various multiple blood test ran all coming back normal. Scheduled to see a neurologist
46 2021-06-25 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hype... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypertension-Medium, Additional Details: Patient said she sat down after vaccine. She said as she was sitting she passed out and fell to the side and hit her head on top. She had a small amount of blood in her hair. We sat her back in a chair and her bp was taken --169/96 and pulse 80. 911 was called and paramedics came to check her out. They said she was okay and she said she was okay to drive. She left on her own.
46 2021-06-26 pain in extremity Headache, fatigue, fever, body ache, chills, extreme sore arm
46 2021-06-27 muscle spasms Fever, headache, body pain, leg cramps
46 2021-06-27 pain in extremity As of today my left forearm is still hurting since vaccine dose 1. It?s very difficult to pull / pus... Read more
As of today my left forearm is still hurting since vaccine dose 1. It?s very difficult to pull / push / turn / lift
46 2021-06-28 pain in extremity broke out at site of injection all the way down arm. broke out in whelps face, and whole body, whole... Read more
broke out at site of injection all the way down arm. broke out in whelps face, and whole body, whole body is itching. pain in left foot
46 2021-06-29 weakness My right arm at my shoulder and my elbow, and the top part of my wrist has had pain that has gotten ... Read more
My right arm at my shoulder and my elbow, and the top part of my wrist has had pain that has gotten progressively worse. I am in physical therapy right now. getting weaker and weaker. I was told I have tennis elbow.
46 2021-06-29 numbness, pain in extremity, tingling, facial pain, muscle twitching 1st shot - Arm was numb and tingly. Patient thought a nerve was pinched. 2nd shot - 2 day after pai... Read more
1st shot - Arm was numb and tingly. Patient thought a nerve was pinched. 2nd shot - 2 day after pain in arm worsened (numb, tingling, throbbing and twitching - very painful), flu-like symptoms (chills, fatigue, dizziness etc.), Fainted and was injured during the fall (took 2 sick days off of work). Cheeks were sore possible immune system over reacting and attaching juvaderm filler in cheeks. Week 2 - developed a head-cold to a sinus infection symptoms: swollen glands, mucous and coughing up phlegm, still fatigued, arm is still numb and tingling but lesser so. Reported reaction to Dr. on 6/30/21.
46 2021-06-29 numbness left side of my face felt numb/ arm was numb; tingling of the lips; developed numb lips; light heade... Read more
left side of my face felt numb/ arm was numb; tingling of the lips; developed numb lips; light headedness/ dizziness; right eye started to twitch; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Left arm on 08Feb2021 11:00 AM (at the age of 46-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history included Heart murmur. The patient family history included her mom had Pancreatic Cancer. The reporter stated that she was pretty healthy, no other conditions. She exercises 2-3 hours. There were no concomitant medications. The patient previously took Vicodin and experienced drug allergy, she stated that it was happened when she went to the dentist, she would get like a heart palpitation and then has to go to the emergency room (ER), this happened way before. Medical condition included reporter stated that she had an allergy to Vicodin, when queried for Lot and Expiry, she stated that it happened when she went to the dentist, she would get like a heart palpitation and then has to go to the ER, She does not have any Lot or Expiry, this happened way before. She is also allergic to Sucralose it gives her lip swelling. If they are related then she knows. She recalls one time she ate something put in which they put sucralose instead of natural sugar and she had a reaction. Historical vaccine included patient took Flu vaccine sometime 2-3 months ago in 2020. She has had No vaccines in the last 4 weeks. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks) and no adverse events prior vaccinations. No other products used. The patient wants information on the Pfizer Covid vaccine. She just received it today (08Feb2021), 1st dose around 11:00 am PT. On 08Feb2021, the patient immediately developed numb lips, light headedness, dizziness, her right eye started to twitch and left side of my face felt numb and also her arm was numb. Currently her "left cheek feels like I was at the dentist and got Novocaine." She experienced numbness on the lips and experienced light headedness. The reporter stated that she still has a little tingling on the lips. The reporter stated that the Light headedness is gone, but also when she was there and they kept her the 15 extra minutes her right eye muscles were twitching, and the twitching is no more, but now she noticed that her left cheek has a little numbness. Her First Dose Date is 08Feb2021 at 11am, After getting the shot she had to wait. When the girl showed up at window saying that she has 5 minutes left and asked if she is okay, caller told the girl that she was not and she was experienced numbness on the lips and light headedness. That was at like 11:13, it was within 10 minutes of 10 minutes. No relevant tests were reported. The outcome of the events right eye started to twitch/ light headedness/ dizziness were recovered on 08Feb2021 and other outcome of the events were unknown. Follow-up attempts are completed. No further information is expected.
46 2021-06-29 pain in extremity Bumps from the shingles and little redder around the edges; Bumps from the shingles and little redde... Read more
Bumps from the shingles and little redder around the edges; Bumps from the shingles and little redder around the edges; Barely had pain; Fever was still in the 99's. She normally ran low at 97.2 or 97.4; Slept for 18 hours; Tired/exhausted; Entire arm hurt so much; Was a little sick with both vaccines; flu-like symptoms; Didn't feel well; Thought she had 3 bug bites on arm; Felt like little person under the skin poking her with needles; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Upper left arm on 15May2021 15:00 or 15:30 (Lot number EW0177) as single dose and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration Upper left arm on 07Jun2021 10:00 (Lot number EW0217) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included Thyroid, Bipolar Depression, Anxiety, Ulcer, Hiatal Hernia, Jitteriness/Hand shaking, Back pain, threw back out all are ongoing and experienced Vitamin D low and Flu shot makes her sick for 24 hours. The patient's concomitant medications included Levothyroxine for Thyroid, Levonorgestrel (MIRENA IUD) for Birth Control, Dextroamphetamine Hydrochloride for Bipolar Depression, Bupropion Hydrochloride (WELLBUTRIN XL) for Bipolar Depression, Pantoprazole for Ulcer, Clonazepam for Anxiety and Bipolar Depression, Lamotrigine for Bipolar Depression, Oxcarbazepine for Bipolar Depression, Propranolol for Jitteriness, Metoclopramide for Nausea, Oxycodone for threw her back out, Tizanidine for Back issue, colecalciferol (VITAMIN D3) for Really tired and Folic Acid for Help regulate menstrual cycle. On an unspecified date 2021 patient experienced Tired/Exhausted, did not feel well, felt like little person under the skin poking her with needles, was a little sick with both vaccines and Entire arm hurt so much and flu-like symptoms. On 07Jun2021 she experienced fever for 24 hours and slept for about 18 hours. Her fever broke and Slept for 18 hours. On 12Jun2021 Thought she had 3 bug bites on arm and on 16Jun2021 she experienced bumps from the shingles she thought she had banged her arm on something when she was working on her apartment. She still had the bumps. They were getting slightly bigger and she still had pain. They were a little redder around the edges. Caller stated that the little dude under the skin was still poking. She said the pain medicine was working. She with the pain killers. Treatment of Shingles took an Antibiotics and pain medication. The outcome of events (pain, fever, shingles and Slept for 18 hours) was not recovered and unknown for other events. Information on Lot/Batch number was available. Additional information has been requested.
46 2021-06-29 pain in extremity I had fever for two three days, arm pain and had problems to breathe. I had to go to the ER.
46 2021-06-29 tingling Left leg felt heavy; left leg felt tingly; This is a spontaneous report from a non-contactable consu... Read more
Left leg felt heavy; left leg felt tingly; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had a history of allergy to levofloxacin (LEVAQUIN). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination, the patient had no symptoms associated for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 18Mar2021, the patient experienced heaviness and tingling in the left leg that corresponded to the arm where the shot was received for 5 days after the vaccine. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of heaviness and tingling in the left leg were resolving. No follow-up attempts are possible. No further information is expected.
46 2021-06-29 tingling Tingling in my left hand and fingers; This is a spontaneous report from a contactable consumer, the ... Read more
Tingling in my left hand and fingers; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route administration in left arm on 17Mar2021 at 1600 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. The medical history of the patient included known allergic to sulfur and blood pressure high. The patient has received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 17Mar2021, at 1630, the patient had tingling in her left hand and fingers. She felt tingling in her left hand shortly after the injection, but she did not think that was unusual. Then she had completed full two days since the injection and had the same tingling. The patient did not receive any treatment for the events. The clinical outcome of tingling was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
46 2021-06-30 numbness Numbness in one of her legs/ I have numbness in one my leg; This is a spontaneous report from a cont... Read more
Numbness in one of her legs/ I have numbness in one my leg; This is a spontaneous report from a contactable consumer (patient) through Medical Information. A 46-year-old female patient received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated she received her 1st dose of the Pfizer COVID 19 vaccine "3 weeks ago." She is scheduled to have her 2nd dose administered today, however states that she is unsure if the symptoms she is experiencing could be a side effect from the 1st dose. She states that the symptoms of numbness in one of her legs began shortly after the time she got her 1st vaccine. She is not sure if the two are related to one another or not but wanted to follow up and ask and see if numbness in the legs a potential side effect is and should she follow through with 2nd dose of COVID vaccination or be seen by HCP. She stated I got the first dose of the vaccine on 22May2021, this was Saturday. So, it's going to be 3 weeks in 2 days. So anyways I have this side effect and I am stepped in to see if this is a side effect of a vaccine because it started around the same time. The outcome of the event was reported as unknown. Follow up attempts are needed; information about lot/batch number has been requested.
46 2021-06-30 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-p... Read more
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 22Mar2021 at 10:45 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included essential tremor. The patient was allergic to sulfa drugs. Concomitant medication included birth control pill (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to vaccination. On 22Mar2021 at 22:00, the patient experienced sore arm. The patient did not receive any other treatment for the adverse event. The clinical outcome of sore arm was not recovered at the time of this report. Information on lot number has been requested.
46 2021-07-01 hot flush Patient got Pfizer vaccine at 2:00 pm and she had reaction to the vaccine at 3:30 pm from the vaccin... Read more
Patient got Pfizer vaccine at 2:00 pm and she had reaction to the vaccine at 3:30 pm from the vaccine. Patient had difficulty breathing, light headed, her lips and nose turn blue to deep red color. Patient's blood pressure was 179/ 100 then second reading was 180/ 115 mmHg with Heart beat of 96. Patient felt chest tightness and hot flashes, she stated that she is going through menopause as well. Administered three ammonia, ice pack, and later on had patient to drink. Called 911 and they came in the mean time. Patient started coming back to normal status and her blood pressure was 130/ 89 with heart beat of 84. Patient agree to go with Ambulance to do full body check up. We will follow up with patient and her PCP to make sure she will be ok.
46 2021-07-01 migraine Migraines lasting all day, sometimes waking up with a migraine, after dealing with them for 3 weeks ... Read more
Migraines lasting all day, sometimes waking up with a migraine, after dealing with them for 3 weeks I received medical help Currently on Sumatriptan 100 MG as needed, still have migraines
46 2021-07-02 burning sensation Face swelling. Starting eyelid/around eyes most obvious.; Face swelling. Starting eyelid/around eyes... Read more
Face swelling. Starting eyelid/around eyes most obvious.; Face swelling. Starting eyelid/around eyes most obvious.; Face swelling. Starting eyelid/around eyes most obvious.; Whole face itchy/burning sensation; Whole face itchy/burning sensation; This is a spontaneous report from a consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3247) via an unspecified route of administration in the left arm on 04Mar2021 at 13:15(at the age of 46-year-old) as single dose for COVID 19 immunisation. The patient medical history included swelling face on unknown date in Jul2020 and Aug2020. The patient did not take any concomitant medication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Any allergies to medications, food, or other products was reported as shellfish and cats. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On 07Mar2021at 19:00, the patient experienced swelling face, starting eyelid and around eyes most obvious, Whole face itchy and burning sensation. Therapeutic measures were taken as a result of the reported events and included treatment with antihistamine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care however the patient contacted her Doctor with pictures via email. The clinical outcome of the swelling face, eye swelling, swelling of eyelids, itchy face and burning sensation was resolving. No follow-up attempts are possible. No further information is expected.
46 2021-07-02 numbness Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Tachycardia-Mild, Additional Details: P... Read more
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient had panic attack after the dose. She felt numbness and stated it was difficult to walk. She insisted Son (pharmacist) to call emergency number. However, once she was feeling better, Son cancelled the emergency number call. However, later, her husband called emergency number. The firefighters stated ptn is fine as she was feeling better was able to go home with her husband.
46 2021-07-02 pain in extremity bad cold.; stomach started hurting; sore joints in wrist up to shoulder, and ankle; arm hurt for 3 d... Read more
bad cold.; stomach started hurting; sore joints in wrist up to shoulder, and ankle; arm hurt for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 01:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had a history of allergy to penicillin, sulfamethoxazole/trimethoprim, latex and bees. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021, after vaccine shot, the patient experienced arm hurt for 3 days. On the 15Mar2021, her stomach started hurting, then after from 15Mar2021 to 20Mar2021, she had sore joints in wrist up to shoulder, and ankle. Next on the 2Mar2021, the patient felt like she had a bad cold. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events arm hurt for 3 days, stomach started hurting and bad cold was unknown while the outcome of sore joints in wrist up to shoulder and ankle was resolved on 20Mar2021. No follow-up attempts are needed. No further information is expected.
46 2021-07-05 weakness 10 hours after 2nd vaccine I got severe body aches and stomach pain. At 8:00am I went to the restro... Read more
10 hours after 2nd vaccine I got severe body aches and stomach pain. At 8:00am I went to the restroom and felt very week and sick. I then passed out on the bathroom floor and my husband called 911. The paramedics took me to the hospital where I received 5 bags of fluid.
46 2021-07-05 pain in extremity Dull chest/arm/neck pain with some shortness of breath, ekg was performed & normal, discussed possib... Read more
Dull chest/arm/neck pain with some shortness of breath, ekg was performed & normal, discussed possible affected lymph nodes, directed to ice area & take Tylenol for pain
46 2021-07-06 weakness, pain in extremity, breast pain Barely felt anything for 48 hours other than a slightly sore arm. As Sunday progressed, I became w... Read more
Barely felt anything for 48 hours other than a slightly sore arm. As Sunday progressed, I became weak, lightheaded, very nauseous, extremely fatigued and had heart palps, shortness of breath with walking, a very sore breast (opposite side of shot) and a fever of 99.5. Day 4 was less intense but all the symptoms remained minus the fever. On Day 5 I went to urgent care... Sore throat, weakness, lightheaded, unable to think, tired to the core, heart palps, racing heart with little exersion, and sore breasts. Day 6 onward still feeling off. A LOT of brain fog and fatigue. Shortness of breath when doing light movement like walking. VERy sensitive to heat.
46 2021-07-06 pain in extremity Shingles; Fever; Slept for 18 hours; Was a little sick with both vaccines; Tired and exhausted; Enti... Read more
Shingles; Fever; Slept for 18 hours; Was a little sick with both vaccines; Tired and exhausted; Entire arm hurt so much; Didn't feel well; she has just gained 100 pounds and was normally about 160 pounds.; it was flu-like symptoms; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0217, Expiration date: Unknown) via an unspecified route, administered in Left Arm on 07Jun2021 at 10:00 (46-year-old at vaccination) as a dose 2, single for COVID-19 immunization. The patient's medical history included ongoing thyroiditis, ongoing bipolar depression, ongoing anxiety, ongoing ulcer, ongoing hiatal hernia, ongoing jitteriness, ongoing hand shaking, ongoing nausea, ongoing back pain, ongoing vitamin d decreased and threw back out (back pain). The patient's family history relevant was reported as none. The patient's past medications included Flu shot which made patient sick for 24 hours, Benadryl which caused allergic reaction. The patient's concomitant medication(s) included ongoing levothyroxine 0.125 mg taken for thyroiditis probably from 2009 or 2010, ongoing levonorgestrel (MIRENA) taken for birth control and regulate her menstrual from 3 years ago, her first one was about 2010 or 20211, dextroamphetamine hydrochloride 100 mg daily, taken for bipolar depression from 2003 and ongoing, bupropion hydrochloride (WELLBUTRIN) 600 mg taken for bipolar disorder from 2003 and ongoing; ongoing pantoprazole 80 mg taken for ulcer, hiatal hernia probably from 2016, took 80mg for 7 or 8 months. Before that she took 40mg, ongoing clonazepam 1-3 mg per day taken for anxiety bipolar depression and sleep from about 20 years, ongoing Lamotrigine 400 mg taken for bipolar depression, switched to 400mg about 4 months ago. 300mg before that. Been on it for about 20 years, taken as off-label use drug, ongoing oxcarbazepine 600 mg taken for bipolar depression been on it for about 20 years. About 3 or 4 months ago, it dropped from 900mg to 600mg, propranolol 80 mg, 3 per day as needed taken for Jitteriness from about ago and ongoing, she said there had never been a period when she has been on it consistently, her hand was shaking, metoclopramide (MECLOPRAM) 10mg, 1 or 2 tablets taken for nausea from 2000 and ongoing; ongoing oxycodone 7.5mg -325mg , 1 every 6 hours taken for threw her back out (back pain), Oxycodone: Has Acetaminophen in it. It was first prescribed about 1 1/2 years ago, taken as needed for back every 6 hour, tizanidine 6 mg capsule once or twice per day, taken for back injury from about 25 years ongoing now, ongoing (MULTIVITAMINS [VITAMINS NOS]) took as healthy nutrients, colecalciferol (VITAMIN D3) 50mcg, 2000 IU taken for vitamin D low and tiredness from 7 or 8 year and ongoing folic acid taken to help her regulate menstrual cycle from 20 or 25 years and Benadryl or Tylenol taken for fever within 2 weeks of her covid vaccine shots. No additional vaccines administered on same date of the Pfizer suspect and was not on any other vaccine Prior Vaccinations (within 4 weeks). The patient was not related to any study or programme. The patient was a really healthy person, at least she was before COVID. She worked out. She used to weigh 160 pounds. She had a good BMI and weight before. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0177) via an unspecified route, administered in upper Left Arm on 15May2021 at 15:00 or 15:30 (46-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient was sick, tired and had fever after first dose of vaccination. The patient stated that she had no idea if this was really her vaccine or not. They said that if anything weird happened, she should report it because the data was being tracked. On 07Jun2021, she was a little sick with both vaccines, fever for 24 hours and slept for about 18 hours. Her fever broke. She slept and was tired for a day and then she was fine. She said that it was a little bit better. She was taking pain medicine less, maybe every 8 hours during the day. She was taking it every 6 hours at night. She stated that it hurt so much. The patient stated that it was the second part where it got weird. She got the second dose of the injection. People kept telling her they reacted within 12 hours. The patient said that she was down in 3 hours. She had fever and was exhausted. She said this was not shocking for her. Her body tended to do that. She ran a fever of 101. She got it on Monday. She tried to work on Monday. About 2 hours after her shot, her boss kicked her off of her computer and she was sleeping. She was running fever then. On Monday, Tuesday and Wednesday, she did not go to work. Her fever was 101 to 101 plus. Thursday she woke up and felt a little better. Her fever dropped to the higher 99's and lower 100's. It did not go higher than 100.2. The patient said that she took Tylenol and it went down for the most part. She was exhausted and didn't feel well. She said still was not feeling well. It was a different kind of not feeling well. After her shot, it was flu-like symptoms. It was different now that she was having pain. She dragged herself to her desk and worked Thursday and Friday. She functioned on Saturday. She slept during the weekend but she was functioning. Saturday her fever broke completely. On 12Jun2021 (Sunday) she woke up with what she thought was 3 bug bites on her arm. The patient stated that she flipped out. She thought it was 3 bug bites. Her entire arm hurt so much. The patient described it as it felt like a little person was under the skin poking her with needles. The patient stated that she sucked it up until Wednesday morning because she tended to do stuff like that. Then she started running a fever again. It started about 99.2 and jumped to 99.8. The bites were still there and she didn't feel well. She stated that her fever was still in the 99's. She normally ran low at 97.2 or 97.4. It was definitely better. It was down in the 99's. The patient stated that he doctor on 16Jun2021 took one look at what the patient thought was bug bites and she said she had shingles. She was put on antibiotic and pain medicine. On Wednesday afternoon she was exhausted and didn't feel well. She took a 2-hour nap. She was busy at work and forced herself to keep working. The patient reported that she was on day 3 of the antibiotic. It definitely still hurts if she doesn't take the pain medicine. She was still running a fever under 101 but over 100. The patient was still working because she doesn't have a choice. She stated that she has just gained 100 pounds and was normally about 160 pounds. Her body was not use to this, she doesn't know if that was flipping her body out or not, it was flipping her out though. The patient consulted her primary HCP to know if there was a possible connection with the shingles and vaccine. But HCP didn't really tell her about it. She was totally shocked. She thought she could only have shingles if she didn't have the chicken pox as a kid. wanted to know if shingles was an unusual or common side effect. She stated that bumps from the shingles started 12Jun2021 or 13Jun2021. She thought she had banged her arm on something when she was working on her apartment. She still had the bumps. They were getting slightly bigger, and she still had pain. They were a little redder around the edges. She stated that the little dude under the skin was still poking. She said the pain medicine was working. She barely had pain with the pain killers. She stated that she got the second dose 07Jun2021. She was supposed to get it on 06Jun2021, but she had to push it off a day. She did not have any tests for the shingles. She said that both the doctor and a nurse practitioner looked and diagnosed her with shingles. The patient received antibiotics and pain medication as treatment medication for Shingles. The patient had not visited emergency room. She visited physician office for 3 bus bites on her arm, shingles. On an unknown date, the patient underwent lab test and procedure which included Body temperature: 101 to 101 plus, 99-100, 99.2-99.8, and 101 (units unspecified). The outcome of the events fever, Slept for 18 hours, tired and exhausted was recovering and the outcome of other events was unknown.
46 2021-07-06 tingling, weakness Right arm heaviness tingling. Started with first shot. Headaches, nausea, and lymph nodes swollen S... Read more
Right arm heaviness tingling. Started with first shot. Headaches, nausea, and lymph nodes swollen Second shot arm still heaviness and tingling. 12 hrs after shot started having fever, chills,headaches, and body aches. Lasted for two days with nausea. It's been 3 weeks and my arm still has heaviness, weakness, and tingling.
46 2021-07-06 tingling Tingling fingers
46 2021-07-07 pain in extremity, numbness Had severe pain from carpal tunnel a day after first shot. fingers remain numb in left hand. got sho... Read more
Had severe pain from carpal tunnel a day after first shot. fingers remain numb in left hand. got shot in left arm. left hand was way worse than in my right as far as pain and numbness.
46 2021-07-07 tingling, numbness Numbness pain tingling in shoulder, neck, and outer back; Cannot do regular tasks such as writing.
46 2021-07-08 hot flush elevated temperature; extreme nausea; hot flashes; vomiting; chills; uncontrollable shivering; Fatig... Read more
elevated temperature; extreme nausea; hot flashes; vomiting; chills; uncontrollable shivering; Fatigued; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6199) via unspecified route of administration in the left arm on 04Mar2021 at 16:00 (at the age of 46-years-old) as a single dose for Covid-19 immunisation and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208) via unspecified route of administration in the left arm on 25Mar2021 at 10:30 (at the age of 46-years-old) as a single dose for Covid-19 immunisation.. The patient had medical history of pneumonia several years ago. Also, the patient was somewhat overweight. The patient had an illness with an 810-week long cough from late Feb2020 - mid Apr2020. It began with one day of chills and fever. Then went straight to respiratory symptoms. Fatigue and tightness in chest lingered for a year. The patient did not know if it was COVID-19, because tests were not available in patients area when the patient was sick, and once tests became available in patients area, the patient did not have qualifying symptoms. The patient never had an antibody test. The patients concomitant medication included occasional vitamin D (UNKNOWN MANUFACTURER), vitamin C (UNKNOWN MANUFACTURER), multivitamins (UNKNOWN MANUFACTURER) and probiotics (UNKNOWN MANUFACTURER). The patients reported allergies included full body rash and hives after MRI contrast dye. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Mar2021, about five or six hours after receiving first dose of vaccine, the patient began experiencing extreme nausea, hot flashes, vomiting, chills and uncontrollable shivering. It was cyclical, hitting the patient in the aforementioned order, over and over for 3-5 hours. Finally, these acute symptoms abated, and the patient fell asleep. When the patient woke the next day, the patients nausea was gone, and body temp was elevated by about one degree above the normal. The patient was fatigued and run down for the next 3-4 days. The patient received no treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of nausea was recovered on 05Mar2021. The clinical outcomes of hot flashes, vomiting, chills, shivering, fatigue and temperature elevation were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
46 2021-07-08 pain in extremity, facial pain, nerve pain, sciatica On 4/5 I had discharge out of my left ear. On 4/9 I had to see an after hours doctor who said there ... Read more
On 4/5 I had discharge out of my left ear. On 4/9 I had to see an after hours doctor who said there was an abscess. There was a hole and pus, and blood were coming out. The left side of my neck was swollen. I also had pain in my neck and behind both my ears and inside my ears. On 4/13 I had to go to an after hours care because I had sudden onset nerve pain in my left lower back. It felt like sciatica. My pain level was a 9.5/10. I was given a cortisone shot which helped. On 4/16 I went to an ENT where I did an CT scan on my left side because my neck was still was still swollen. He did say my ear was healing. I was also sent to physical therapy which helped a little. On 4/18, I noticed that my right wrist carpal tunnel flared up. My right wrist became enflamed and my right upper arm began hurting. The lower back pain also became enflamed. The left side of my face hurt and inside my left ear, around the cartilage I had another sore. I also was experiencing a dry mouth.
46 2021-07-08 tingling, sciatica, nerve pain, pain in extremity On 4/20 I had a very sore arm and left lower buttock pain. I had a sore throat and inside my throat ... Read more
On 4/20 I had a very sore arm and left lower buttock pain. I had a sore throat and inside my throat hurt. My left side jaw also hurt. I also had shooting pains up both my arms from carpal tunnel. I had pins and needles in my hands which is something I never experienced on 4/22; I had diarrhea begin. On 4/23, the ear pain came back in both ears. On 4/24, I had sudden nerve pain on the right lower back, and I had to go to an afterhours clinic. I was given a cortisone shot that provided immediate relief. On 4/25, I got a CT scan that was ordered. On 4/27, I saw an ENT. He said my carotid glands were inflamed. He said my blood tests showed I was ANA positive. He said it could indicate an autoimmune disease. Due to the cortisone shot, further workups had to be delayed. He told me to see a rheumatologist. On 4/28, my arms swelled up, more on the left side, and I had left ear pain and the left side of my neck was very inflamed. My IBS was also really bad. On 6/3, I saw the rheumatologist, who said I needed to wait on my blood work. I had continued ear, back and arm pain. On 5/4, I had what I thought was a clogged pore. I wear glasses and it was very tender It got to a point that I had to get contacts because I could not wear glasses. On 5/4, my nose started bleeding in the outside and the inside of my nose hurt. On 5/5, I saw the dermatologist. I had more blood and pus come out that day as well. The dermatologist said it was a boil. He told me to put mupirocin. This was not helpful. I had intermittent hand pain, dry mouth and continued ear pain. On 5/9, I was able to get lab work. On 5/12, after the doctors thought I had Sjogren's, everything came back normal, and I did not have any disorder. On 5/14, I woke up with both sciatic nerves completely on fire. I went to the chiropractor, sports medicine doctor I was referred to. They did a deep muscle massage and 30 mins of active therapy. I was taught some stretching exercises which were helpful and provided relief. On 4/24, the sciatica pain subsided for the weekend but came back. I looked up some exercises which provided relief. The next day, I might have done something wrong because the pain got worse. The boil on my nose finally went away after I used cystic acne medication on it. The arm pain calmed a bit as I was not having constant pain. On the week on 6/21, I started having chest pains. I was not sure what was going on. On 6/25, I realized things were not getting better. I decided to take things easy. Things got worse. It felt like an elephant sitting on my chest. On 7/2, I was remarkably worse. I went to the ER where my vitals were okay. I was in so much pain. The pain reminds me of shingles pain although not as bad. I was told to visit and internal doctor. I was given lidocaine patches and prednisone. The blister on my chest has gotten worse and I have developed a few more. The pain on my chest now wraps around my back. I am seeing a doctor today.
46 2021-07-08 seizure Patient was admitted overnight due to seizure activity. Upon arrival, patient stated that they were ... Read more
Patient was admitted overnight due to seizure activity. Upon arrival, patient stated that they were contacted by their PCP's office saying she received more of the Pfizer vaccine than recommended. When investigated, it was identified that the patient received 1 vial of 6 doses (1.8 mL) rather than 1 single dose (0.3 mL).
46 2021-07-10 pain in extremity pain at the injection site; sore arm; This is a spontaneous report from a contactable consumer or ot... Read more
pain at the injection site; sore arm; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 46-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Jun2021 10:30 (Batch/Lot Number: EW0121) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastric bypass 2019, hospitalisation, Flu Vaccine and Pneumonia vaccine; states she was hospitalized after receiving the vaccines , metabolic surgery in 2019. The patient's concomitant medications were not reported. Family Medical History Relevant to AE were none, no one she knows of had a reaction. The patient experienced sore arm on Jun2021, pain at the injection site on 01Jun2021. There was no relevant test performed and no investigation assessment. The patient stated after her first dose of the Pfizer COVID-19 vaccine and no issues other than a sore arm that went away in 2 days. States caller said that she also get the flu and Pneumonia after receiving those vaccines. Caller states after her first dose, she had pain at the injection site and so did her entire family, but they had that pain for 2 days and then it went away. Caller states if they could educate her daughter at home, she wouldn't have taken the shot, but they decided to take it as a family. Caller states she doesn't do well with vaccines but she couldn't stomach giving her daughter a vaccine that she wouldn't take. Caller states now she feels she shouldn't have taken it and just kept taking her natural immune boosters and vitamins because she did fine. Caller states she was around people that had Covid 19 and she has been around lots of people and travelled and was fine. She would not have taken that vaccine. She just went on the 10Jun2021, so after the first vaccine, she had herself checked because she did have bariatric surgery in 2019 and she has to do a checkup. Caller states her vitals and blood work and everything were tested, and the only thing she needs more of is Iron and Vitamin D. Caller states the only tests that came back that she needed to be aware of and do something about, outside of that nothing. States she is going to the doctor to get an iron infusion. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not require emergency room and physician office visit. Prior Vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations were flu Vaccine and Pneumonia vaccine; states she was hospitalized after receiving the vaccines. NDC, Lot, Expiration: Unknown. Caller states she doesn't get sick with the flu unless she takes a flu vaccine and she doesn't get pneumonia unless she gets a pneumonia vaccine. Caller states she got this vaccine and now she is sick, she won't do a vaccine ever again. The outcome of the event arm was recovered on Jun2021 and the outcome of the event pain at the injection site was recovered on 03Jun2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021788760 same reporter/drug, different patient.
46 2021-07-11 weakness My joints started aching on 6/19/21 and continued to get worse for 2 weeks. I had no energy and a c... Read more
My joints started aching on 6/19/21 and continued to get worse for 2 weeks. I had no energy and a constant headache for 3 weeks. My head covered in blisters on 6/19/21, then my right foot became covered in blisters on the 20th and both of my hands started blistering on the 21st. I?m still having a lot more blisters appear every day.
46 2021-07-11 feeling cold, numbness Arm numb, back pain, cold
46 2021-07-11 pain in extremity chest pain and left arm pain
46 2021-07-11 tingling, sensory loss, numbness diminished sensation, numbness nd tingling in bilateral hand and feet
46 2021-07-12 weakness, pain in extremity I could not lift my left elbow from the side of my body due to pain and weakness for 48 hours. I sti... Read more
I could not lift my left elbow from the side of my body due to pain and weakness for 48 hours. I still have trouble lifting my arm to a position straight out from my body or higher, with an intense increase in pain when I try to lower my left arm without assistance from my right arm. I can no longer lay down on my left side due to pain in my arm and suffer from aching in my arm periodically for no apparent reason. I have tried physical therapy, massage therapy and acupuncture to restore full range of motion and pain relief, with no success.
46 2021-07-12 feeling hot hot; nauseous; heart was racing; This is a spontaneous report from a contactable consumer (patient).... Read more
hot; nauseous; heart was racing; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number: EW0186), via an unspecified route of administration on 25May2021 at 12:00 (at the age of 46-years) as single dose in the left arm for covid-19 immunisation. The patient's medical history included hypothyroid and had food allergies. The patient's concomitant medications included levothyroxine sodium (SYNTHYROID), Cetrizine from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25May2021 at 12:00 within 10 minutes of receiving vaccine the patient experienced hot, nauseous, and heart was racing. Patient stated that pharmacist gave me two doses of Benadryl and one of Tylenol. After a bit the symptoms abated. Patient scheduled an appointment with my PCP to discuss this reaction. She advised to continue and get the second dose. She had the second dose and the onset was faster and more severe. She had the shot and with 3 minutes she was dry heaving, very congested, throat felt tight. She could still breathe. This all happened even though she took Benadryl and a Tylenol 45 minutes prior to her injection. Again, the pharmacist gave a dose of Benadryl to help with the effects of the vaccine. She would like to know what is in the vaccine. Patient stated that she had food allergies and this reaction is frightening. Ae resulted in clinic visit and ER visit. The outcome of the events was resolved. Information on Lot/Batch number was available. Additional information has been requested
46 2021-07-12 pain in extremity, limb paralysis March 31-had first covid vaccine April 14 - had under eye filler - hyaloronic acid filler. I've ha... Read more
March 31-had first covid vaccine April 14 - had under eye filler - hyaloronic acid filler. I've had this before with no reactions. I wasnt made aware by the facility administering - that there could be a potenial side affect with vaccine. I told them I had just gotten my first vaccine dose March 31 - was part of a general conversation as I'm a regular patient and friendly with the woman administering. Sat May 1 - was outside doing yardwork/weeding all day. Came in and my eyes were itchy, red and swelling badly around 4pm. Took Benadryl. It did nothing. Eyes kept getting worse but I didnt know what to do. I went to bed. Next morning my eyes (under eyes especially) were swollen almost to the point of not being able to see - so puffy, red, black/blue it looked like I got in a punching fight. I took pictures. I also couldnt get out of bed (was 5am). My legs were completely paralyzed. Completely. I was so scared not being able to walk. i laid there for hours not knowing what to do, but I had to go the bathroom so badly. Finally at 9am I crawled out of bed and pulled myself along the floor and sat down to get myself down the stairs and to the bathroom.. The pain in both my legs was excrutiating. I was in tears. I was able to barely walk around 10am still in excrutiating pain. I took 500mg of Motrin. I didnt do very much. Sunday i couldnt do anything. I was supposed to have my kids that day but i could barely walk so they had to stay with their dad. No doctors would see me as they were closed. First thing Monday am i drove to my skin doctor and begged her to see me and give me steroids. I had done research and figured out I was having a reaction to vaccine and needed steroids to calm down my immune system. She agreed and gave me a 6 day dose of steroids. I took them. Pain in legs, swelling, etc. continued but was better on Tuesday. I still have under eye swelling to this day - July 13th. Seen many doctors since. The leg situation repeated itself. The system is going to log me out so I can't type in more details. I have accurate records of everything. I just cant believe the govt would endorse a vaccine that im still having terrible adverse affects to this day. I'm so depressed.
46 2021-07-12 tremor, seizure, tingling Chipped tooth; eye sight has gotten blurry; Her arms were going all over the place. Her arms are tin... Read more
Chipped tooth; eye sight has gotten blurry; Her arms were going all over the place. Her arms are tingling. Her muscles and stuff are sore because of the blood, she was shaking so hard.; Her arms were going all over the place. Her arms are tingling. Her muscles and stuff are sore because of the blood, she was shaking so hard.; Her body got into chills, she thought she was having a seizure; shaking so hard she thought she would fall on the floor; Her body got into chills, she thought she was having a seizure; shivering so hard she almost broke her teeth; typical mild fever, stomach ache, drowsy. She felt like she had the flu.; typical mild fever, stomach ache, drowsy. She felt like she had the flu.; typical mild fever, stomach ache, drowsy. She felt like she had the flu.; typical mild fever, stomach ache, drowsy. She felt like she had the flu.; heart went funny and felt like she was going into the floor; Felt like she couldn't walk, dizzy, felt like she was floating; Felt like she couldn't walk, dizzy, felt like she was floating; Chest hurt; This is a spontaneous report from a contactable consumer. This is report 1 of 3. This consumer reported for self that the 46-year-old female patient received bnt162b2 (BNT162B2) at the age of 46-year-old, dose 1 via an unspecified route of administration, administered in Arm Right on 07Jun2021 09:40 AM (Batch/Lot Number: EVV0181) as dose 1, single for covid-19 immunisation. Medical history included seizure (she was diagnosed when she was 18 years old. Her sister had them too.), scleroderma (She was diagnosed 10 years ago.), epilepsy and all from an unknown date and unknown if ongoing. Family Medical History was none. Concomitant medications included prednisone (PREDNISONE) at 2.5mg, 1 tablet daily for scleroderma for 6 years; leflunomide (LEFLUNOMIDE) at 10mg tablet once daily for scleroderma 2 years ago; levetiracetam (LEVETIRACETAM) at 750 mg 4 tablets daily for epilepsy 20 years ago; phenobarbital (PHENOBARBITAL) at 64.8 take 4 of them, tablet for epilepsy (Started taking it 30 years ago. You'd think she'd be knocked out, but she's so used to this stuff); lamotrigine (LAMOTRIGINE) at 100 mg, 6 a day for epilepsy (Started taking it at least 20 years ago, its been a while, before she had her boy.). The patient experienced her body got into chills, she thought she was having a seizure on 25Jun2021 with outcome of recovered with sequelae, shivering so hard she almost broke her teeth on 25Jun2021 with outcome of recovered with sequelae, typical mild fever, stomach ache, drowsy. she felt like she had the flu on 07Jun2021 09:45 with outcome of recovered with sequelae, heart went funny and felt like she was going into the floor on 07Jun2021 with outcome of recovered, felt like she couldn't walk, dizzy, felt like she was floating on 07Jun2021 with outcome of recovered, shaking so hard she thought she would fall on the floor on 25Jun2021 with outcome of recovered with sequelae, eye sight has gotten blurry on 26Jun2021 with outcome of not recovered, her arms were going all over the place, her arms are tingling, her muscles and stuff are sore because of the blood, she was shaking so hard on 25Jun2021 with outcome of recovered with sequelae, chest hurt on 07Jun2021 with outcome of recovered, chipped tooth on an unspecified date with outcome of unknown. The clinical course was reported as follows: Consumer states she is calling about the COVID shot, later verified as being Pfizer manufactured COVID shot. She received it on 7Jun2021. When she first got the shot she experienced typical mild fever, she expected it to happen but was out for about a week. Her sister told her she had an odd reaction to it, she said get ready. Friday, she had the same reaction her sister did. Her body got into chills, she thought she was having a seizure but she knew it wasn't seizure because she has epilepsy and this was different. She wasn't cold, but she was shivering so hard she almost broke her teeth. Her twin sister had same thing. She was shaking like cold extreme, she was in a ball. She had to keep from cracking her teeth. She tried to get out of bed but she couldn't stop. She was shaking so hard she would fall on the floor. She thought she was in shock or had a sugar thing. The following day she had a mild fever, her legs hurt, her hands hurts, she still has a mild headache. She also had stomach ache, drowsy, felt like she had the flu. Consumer states her sister and her sisters husband experienced the same thing. 3 people that had the same thing. Consumer states she was really cold but if she could've she would have shrunken into a tiny ball and disappeared she would have. Her sister and her sister's husband also experienced this so she doesn't know if it's the batch or what. She is calling her doctor to see if she should take a second one or what. Her boy is taking the second one today. Consumer states when she first had the shot she had a heart population-documented as verbally provided by caller; described by caller as her heart went funny and she felt like she was going into floor. She has epilepsy. She had to go home, she had a kid with her. After that her chest hurt for a little bit, for a full week. She thinks it was a nerve thing. She has never experienced anything like this before. She has had seizures before, this was not seizures. She states there is something wrong. She was shaking and chipped her tooth. She was trying to keep from biting her cheeks. Her arms were going all over the place. Her hands and feet, arms were tingling. Her muscles and stuff are sore because of the blood she guessed, she was shakng so hard. Consumer states she didn't feel cold. Her legs were contracting in, more like she was going into shock or having a sugar thing. She was wondering if she should ask her husband to get bananas. She doesn't have diabetes. Consumer states she has a twin sister she had this too. Consumer states she is still recovering from the muscle pulls and stuff. Her hands and legs hurt muscles from her rib cages from pulling. Caller mentioned she was going to get her glasses and reported another thing is her eye sight has gotten blurry. Her eyesight was bad as it is, but is worse now. It is very blurry. Consumer states this started a day after the shivering, on 26Jun2021. Consumer states she is still running a low grade fever. She thinks it is a second response, she was reading it could be a delayed reaction, she states it is weird. Consumer states her eye sight is so bad. Her calves hurt really bad. Vaccination Facility Type was Pharmacy. No AE required a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Relevant Tests was none after Vaccination.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Seizure and Chipped tooth cannot be totally excluded. It is noted that the patient has the medical history of seizure. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-07-13 muscle spasms I received my first shot on 7/1. My cycle should?ve started on July 4th. I had bad cramps (which I ... Read more
I received my first shot on 7/1. My cycle should?ve started on July 4th. I had bad cramps (which I never have) but no period until 7/10. I am never late and this period was very heavy and bad cramps. Im believing this was due to the vaccine as this was the only thing that changed in my life. (I also took a pregnancy test to ensure I wasn?t having a miscarriage, test was negative). Wanted to report this as a possible side effect (as I researched and do see some others had changes in their period post vaccine around 1%).
46 2021-07-13 pain in extremity, flushing vitals-149/89; cobblestoning posterior pharynx; sensation of throat closing; nausea; pruritis; aller... Read more
vitals-149/89; cobblestoning posterior pharynx; sensation of throat closing; nausea; pruritis; allergic reaction; tired; flushing; itchy throat/ scratchy throat; erythema/ Localized Erythema; burning pain at site; confusion; trouble swallowing; Blurry vision; Ringing ears; Headache; arm soreness; injection site noted improved with very pale pink discoloration noted to site; This is a spontaneous report from a contactable consumer or other non hcp. This is a report received from for self via FDA (VAERS Number: 903469). A 46-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 17Dec2020 17:30 (Batch/Lot Number: EK5730 exp date :Mar2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included rubber sensitivity from an unknown date and unknown if ongoing Allergies to medications, food, or other products: Latex , food allergy from an unknown date and unknown if ongoing Allergies to medications, food, or other products: Pine nuts , hypothyroidism from an unknown date and unknown if ongoing , osteoarthritis from an unknown date and unknown if ongoing , anaphylactic reaction from an unknown date and unknown if ongoing Allergies to medications, food, or other products: Latex-Anaphylaxis , dermatitis contact from an unknown date and unknown if ongoing Allergies to medications, food, or other products: Tape. Concomitant medication(s) included sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]) taken for an unspecified indication, start and stop date were not reported; butalbital, caffeine, paracetamol (FIORICET) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; meloxicam (MELOXICAM) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, bioflavonoids nos (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]) taken for an unspecified indication, start and stop date were not reported. The patient was allergic to Levothyroxine, fioricet, Vitamin C. The patient previously took codeine, hydrocodone and experienced drug hypersensitivity, hydrocodone and experienced anaphylactic reaction, influenza vaccine and experienced erythema. After receiving the first dose of bnt162b2, the patient experienced flushing on 17Dec2020 19:58, burning pain at site on 17Dec2020 17:40, itchy throat/ scratchy throat on 17Dec2020 17:58, confusion on 17Dec2020, trouble swallowing on 17Dec2020, erythema on 17Dec2020 17:58, blurry vision on 17Dec2020, ringing ears on 17Dec2020, headache on 17Dec2020, arm soreness on 17Dec2020, injection site noted improved with very pale pink discoloration noted to site on 17Dec2020, tired on 18Dec2020, vitals-149/89. On an unspecified date, the patient's spo2 was 98%. The patient had cobblestoning posterior pharynx, sensation of throat closing, nausea, pruritis, allergic reaction. The patient had an emergency room and physician office visit for the events. Therapeutic measures were taken as a result of flushing, burning pain at site, itchy throat, confusion, trouble swallowing, erythema, blurry vision, ringing ears, headache was ice pack, Benadryl 50mg po via oral route of administration and Solumedrol 125mg IM X1 via intramuscular route of administration. The patient was treated with Epi 0.3 mg 1M, Sodium Chloride 0.9 %, Diphenhydramine 25mg IVP, Ondansetron 4mg IVP, cetirizine 10 mg PO, Famotidine 20 mg PO. The outcome of the events flushing, burning pain at site, itchy throat/ scratchy throat, confusion, trouble swallowing, erythema/ Localized Erythema, Blurry vision, Ringing ears, Headache was reported as recovered on 22Dec2020. The outcome of the events arm soreness was reported as recovered on an unspecified date. The outcome of the events tired was reported as recovering at the time of report. The outcome of the events Vaccination site discolouration, Blood pressure increased, Cobble stone pharynx, Throat constriction, nausea, pruritis, allergic reaction was reported as unknown. Follow-up (08Mar2021): New information received from a contactable consumer included correct lot number, event and treatment details. Follow-up attempts are completed. No further information is expected.
46 2021-07-14 feeling cold I woke up with my arm feeling very sore in the muscle where the shot was given. I took Ibuprofen lat... Read more
I woke up with my arm feeling very sore in the muscle where the shot was given. I took Ibuprofen later in the morning, which helped a little, but I could tell when it was wearing off that afternoon because I started to feel achy all over by about 4pm, so I took another dose of Ibuprofen. That helped me feel better, but I got tired sooner than usual. I settled into bed by 10pm and felt cold and shivery. I took more Ibuprofen and was able to sleep. The next morning I felt much better, like I do after I get over a fever. I did normal activities, but by the afternoon I felt exhausted like I'd done too much, so I took a nap. I felt okay by the next day.
46 2021-07-14 numbness, pain in extremity I felt pain going down my arm and into my neck. The joints in my left arm got really tight. I woke u... Read more
I felt pain going down my arm and into my neck. The joints in my left arm got really tight. I woke up in the middle of the night and my left arm was numb. In about 2 weeks I started to get numb in both arms. After a few more weeks I woke up with numbness in my legs. I felt drained and I decided to go see my doctor, as I was driving to the doctor my feet went numb. After test were ran everything came back normal. My psorasis started to get worse.
46 2021-07-15 weakness Within 2 hours of my 2nd covid injection on 6/15/2021 at 4:30pm, I had serious vertigo and had to li... Read more
Within 2 hours of my 2nd covid injection on 6/15/2021 at 4:30pm, I had serious vertigo and had to lie down. I became almost unconscious ( I could hear what my husband was telling me but I could hardly talk, due to the lack of energy, my body was completely limp, I could not move any part of my body). I hardly slept the first night, I felt sick and couldn't eat or even drink water without feeling nauseous or vomiting. When I got up to go to the bathroom in the morning of 6/16/2021, I fainted and my husband found me unconscious in the bathroom. After I became conscious again, he brought me back to bed where I stayed all day. I couldn't lift my head without having terrible vertigo, and feeling I was going to faint again. I had a strong headache as well. The following day 6/17/2021, the symptoms started to be less strong and by 6/18/2021, the symptoms and vertigo had almost gone.
46 2021-07-15 facial paralysis a few days following this 1st dose of pfizer mrna covid vaccine i experienced very mild facial paral... Read more
a few days following this 1st dose of pfizer mrna covid vaccine i experienced very mild facial paralysis located only in my bottom lip. this lasted about a week or so and seems to have improved. i also received a dose of the johnson and johnson vaccine on March 17, 2021 with no adverse effects to report following that immunization.
46 2021-07-17 weakness Felt very week,; following day, I got fever,; headache,; bodyache; joint pain,; nauseas.; after 3 hr... Read more
Felt very week,; following day, I got fever,; headache,; bodyache; joint pain,; nauseas.; after 3 hrs receiving vaccine got extremly tired.; Very sleepy, slept into the following day.; This is a spontaneous report received from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:ER8732), via an unspecified route of administration in the left arm on 26Mar2021 at 13:45 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications were reported as none. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 17:00, the patient experienced extremely tired, very sleepy, slept into the following day. On27Mar2021 patient experienced fever, headache, body ache, joint pain, nauseas, and on an unknown date felt very week and slept most of the day. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. The patient took TYLENOL as treatment for the reported events. The clinical outcome of the events extreme fatigue, very sleepy, fever, headache, body ache, joint pain, nauseas and very weak was resolving at the time of the report. No follow-up attempts are needed. No further information is expected.
46 2021-07-17 feeling hot, weakness having some side effects such as diarrhea; feeling really tired and I fall asleep; I am feeling weak... Read more
having some side effects such as diarrhea; feeling really tired and I fall asleep; I am feeling weak; feeling a little hot; Dizzy; This is a spontaneous report from contactable consumer (Patient). A 46-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, and Lot number: EW0187) via unspecified route of administration, administered in left arm on 01Jul2021 10:10 (at age of 46-year-old) as dose 2, single for COVID-19 Immunization. Patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were none. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0173) via unspecified route of administration in left arm on 10Jun2021 (at age of 46-years), as Dose 1 single, for COVID-19 Immunization. On 01Jul2021, the patient stated that she received the second dose yesterday and she had been having diarrhea ever since, it had not stopped and she was feeling weak, it seems like anything that she eats or drink it just did not stay in her stomach and she asked that what should she do and how long was this going to last. On the same day, the caller stated that she was feeling dizzy and weak; she was feeling really tired, and she fell asleep, and when she woke up, she was feeling a little hot, but she washed her face to cool off and she was okay. She was asking for recommendations on what she should do about the side effects she was experiencing. The caller was still experiencing events and was enquired about how long this was going to last. Patient did not receive treatment for events. The outcome of event feeling hot was considered as resolved, on an unspecified date in Jul2021, while the outcome of the rest of the events was not resolved. Information on Lot/Batch number was available. Additional information has been requested.
46 2021-07-17 feeling hot lightheadedness/dizziness; Hot; sweaty; This is a spontaneous report from a non-contactable other he... Read more
lightheadedness/dizziness; Hot; sweaty; This is a spontaneous report from a non-contactable other health professional. A 46-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6205) via an unspecified route of administration on 18Mar2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Mar2021, during her 15 minutes waiting period after the injection, the patient began to experience light-headedness and dizziness. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. The patient complained of dizziness, hot and sweaty. The treatment given for the reported events included water and ice pack and the patient responded very well to treatment. The patient was discharged and was stable to go home. The clinical outcome of the events light-headedness, hot and sweaty was unknown at the time of this report. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination facility country was added and lead sentence in narrative was updated to non-contactable healthcare professional.
46 2021-07-17 fibromyalgia, weakness had tiny pimples in my arms, chest; reddish color on my face; rashes; general malaise associated wit... Read more
had tiny pimples in my arms, chest; reddish color on my face; rashes; general malaise associated with fibro is increasing; weak; puked; general malaise associated with fibro is increasing; fatigue is worsening/feel totally drained; can't even walk without feeling the necessity to rest; have a headache that feels like something is pumping in my brain; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0168), via an unspecified route of administration in right arm on 14Jun2021 at 12:00 as (at the age of 46 years old) single for covid-19 immunisation. Medical history included fibromyalgia, don't have a thyroid and have high blood pressure. The patient had allergic/not common side-effects to around 30 medicines, food allergies, dust and other allergies. Concomitant medications that patient received within 2 weeks of vaccination included levothyroxine sodium (EUTHYROX), 75 microgram, lisinopril 7.5g total, others. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 14Jun2021, at 12:15, 15 minutes after of receiving the first dosage, she had tiny pimples in her arms, chest and reddish color on her face. This kind of allergic reaction she had in the past and normally develops in short breath and other symptoms. At that point she took 2 pills of desloratadine 5 mg. Since then (today is 24Jun) fatigue is worsening. She can't even walk without feeling the necessity to rest. She also feels totally drained after eating, her rashes come and go during the day and general malaise associated with fibro is increasing. She feels very weak. Since last night she has a headache that feels like something is pumping in her brain. Today she puked. She is asking how long these symptoms will last. The adverse event resulted: Doctor or other healthcare professional office/clinic visit. The patient received treatment due to the had tiny pimples in my arms, chest, reddish color on my face and general malaise associated with fibro is increasing. The outcome of events was not recovered. Information on Lot/Batch number was available. Additional information has been requested
46 2021-07-17 pain in extremity Administration date=04Feb2021, Administration time=03:45 PM; Administration date=28Dec2020, Administ... Read more
Administration date=04Feb2021, Administration time=03:45 PM; Administration date=28Dec2020, Administration time=01:00 PM; right side underarm was swollen and painful; arm pain; Fever; Body aches; This is a spontaneous report from a contactable Other Health Care Professional (patient). A 46-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9265/Batch number was not reported) via an unspecified route of administration, administered in arm right on 04Feb2021 at 15:45 (at the age of 46-years-old) as dose 2, single for covid-19 immunization. Medical history included headache, covid-19 from 08Jan2021 to an unknown date (COVID dx. 08Jan2021 (mild sx) recovered) and known allergies Sulfa. Concomitant medications included vitamin c [ascorbic acid] (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; zinc (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; vitamin b complex (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; famotidine (PEPCID [FAMOTIDINE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication;magnesium (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; meloxicam (MEL) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. Patient didn't receive other vaccinations within 4 weeks prior to vaccination patient had COVID prior to vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL1284) via an unspecified route of administration in arm right on 28Dec2020 at 15:45 as dose 1, single for covid-19 immunization. On 05Feb2021 (Friday) at 02:00 AM, the patient experienced body aches and at 07:00 PM, fever began. On 06Feb2021 at 06:00 AM, felt arm pain and noticed my right side underarm was swollen and painful. Reviewed side effect profile and saw that some people did have lymphadenopathy and therefore I decided to wait it out. I did not seek medical attention. As of 08Feb2021 (Monday), the swelling has diminished considerably on its own and the pain reduced to only if I touch it. On 09Feb2021, the swelling is gone and the pain only when deeply touch is almost gone. The clinical outcome of the right side underarm was swollen and painful, body aches, fever, arm pain was recovering and of the administration date=04Feb2021, administration time=03:45 PM; administration date=28Dec2020, administration time=01:00 PM was unknown. Follow-up attempts completed. No further information expected.
46 2021-07-17 pain in extremity Swelling of my face and throat, dizziness, injection site pain, arm pain, headache, tiredness, muscl... Read more
Swelling of my face and throat, dizziness, injection site pain, arm pain, headache, tiredness, muscle pain, feeling unwell, shortness of breath a little bit
46 2021-07-17 tingling Tingling down left arm and feet; pain at elbow joint; This is a spontaneous report from a non-contac... Read more
Tingling down left arm and feet; pain at elbow joint; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) in the left arm on 26Mar2021 at 09:00, (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune hashimoto's and hypothyroidism. The patient had known allergies to egg whites and milk. Concomitant medications included levothyroxine sodium (SYNTHROID), vitamin d (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 19:00, the patient experienced tingling down left arm and feet and pain at elbow joint. No therapeutic measures were taken to treat the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.The clinical outcome of the events tingling down left arm and feet and pain at elbow joint was not recovered, at the time this report. No follow-up attempts are possible. No further information is expected.
46 2021-07-17 paralysis, numbness Her face felt like numb and paralyzed like she had Covid; allergic to first dose; Her face felt like... Read more
Her face felt like numb and paralyzed like she had Covid; allergic to first dose; Her face felt like numb and paralyzed like she had Covid; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9266, number and Expiry Date are Unknown, time the vaccination was given: not provided), via an unspecified route of administration, administered in Left arm on 23Feb2021 (at the age of 46-years-old) as dose 1, single dose for covid-19 immunisation. Medical history included blood sugar diabetes and high blood pressure from 4 years and thyroid from an unknown date and unknown if ongoing. She stated, just before this, she went to the hospital 3 weeks ago, to the emergency room, because of a kidney or urine infection and it still hurts, but they still hurt. She was asked to clarify whether the emergency room visit and the kidney or urine infection occurred prior to when she has received the Pfizer Covid-19 Vaccine or if it was after. She stated, no, this happened prior to receiving the vaccine. No additional details provided. Treatments: She mentions that she inhales a spray that she has for asthma. No additional details are provided. Investigation Assessment was No. The patient's concomitant medications were not reported. She was asked if there are any medications she takes and has taken and any medical conditions. She states she suffers from blood sugar diabetes, high blood pressure, and that is why she takes medication. She does not provide additional information and does not provide medication list. She was asked how long she has been diagnosed with these conditions and stated 4 years. No additional information provided. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): see report. Additional vaccines administered on same date of the pfizer suspect if applicable, list all vaccines administered on same date with the pfizer vaccine considered as suspect were none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were none. AE(s) following prior vaccinations were none. family medical history relevant to AE(s) was not provided. Relevant tests were none. It was reported that first dose was on 23Feb2021. She was allergic to it, as well, when she got the first dose. Her face felt like numb and paralyzed like she had Covid on an unspecified date in Feb2021. They did not want to give her the second vaccine because she had a reaction prior to this one. She states no other information is on the card, but it does say something like Allergy and Allergist or there is something weird they put on the card. She does not provide additional details. Adverse events required a visit to Emergency Room and Physician Office. She does not clarify her reaction after the first vaccine. She confirms she did have a reaction following the first vaccine, and now has experienced all of the events listed over the last few days after the second vaccine. She does not provide additional details. She was asked if she needs any additional assistance and states she just has a question, right now she is at (Withheld), the big one. There is a clinic and an emergency room and she wants to know where to go. She was advised to contact her physician or local health authority for information and that Pfizer does not provide medical advice. Reporter seriousness for allergic to first dose: face felt like numb and paralyzed like she had Covid was Unspecified. The outcome of events was unknown. Follow-up (06Jul2021): Follow-up attempts are completed. No further information is expected
46 2021-07-18 weakness Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Diffi... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Severe, Systemic: Weakness-Severe
46 2021-07-18 pain in extremity, restless legs syndrome Arm Pain 6pm, Headache the following 2 days all day long, brain fog the following day of vaccine, Di... Read more
Arm Pain 6pm, Headache the following 2 days all day long, brain fog the following day of vaccine, Diarrhea 4 days now, glands under arm (same with injection) swollen painful days 3 and 4 after vaccine, 2nd night had insomnia, days 3-4 had restless legs at bedtime.
46 2021-07-18 pain in extremity Ok the reason I ended up having to seek care from the DR is because the onset of a severe headache t... Read more
Ok the reason I ended up having to seek care from the DR is because the onset of a severe headache that I started to get about an hour after the 2nd dose of the vaccine and it would not go away on it's own. I also had body aches and a sore arm but those are not something that I got attention for. I believe I contacted the DR on the same day but I am not totally certain. The DR ended up giving me pain medication which ended up making the headache go away. The headaches lasted for six days before I was able to get medication and take care of it. I get migraines but this was very different, a different headache.
46 2021-07-18 pain in extremity After having the vaccination and waiting 15 minutes at my PCP's office I left. My husband was drivin... Read more
After having the vaccination and waiting 15 minutes at my PCP's office I left. My husband was driving and took me to a local supermarket where I shopped for a short time and then returned home. My home, the PCP and the supermarket are all within close proximity. Upon return home, I was walking in front of my husband, wearing an ankle boot prescribed by my Podiatrist, and a skirt. My husband asked why my left leg calf was twice the size of my right. I entered our home, set in the recline, removed the ankle boot and noticed a huge amount of swelling from my left foot to just up above my left knee. It was indeed twice the size, perhaps a bit more, than my right side. Also, just below my left, on the side of my inside calf, there was an XL raised, red, clearly outlined/defined area. approximately 4 inches by 2.5/3 inches. There was pain within the area and radiating. I immediately took an aspirin and called my podiatrist thinking that the ankle boot was causing this. (the vaccine did not even enter into my mind) I had to leave a message on the machine at the podiatrist's office and received a return call within 2 to 3 hours by a RN telling me to go to closest ER ASAP. In the meantime while waiting to hear back, I remained seated with leg elevated . I went to ER. I was seen very quickly, ultrasound was provided to rule out DVT. By the time I reached the ER (approximately 1:30), the mass had significantly decreased. The ultrasound showed no DVT. The ER MD diagnosed most likely superficial blood clot and it would not have been caused by boot. Made contact with RN at PCP, she instructed me to file report with CDC.
46 2021-07-19 breast pain pain all over my body; pain left arm pit; pain in my left breast; Some chill; very fatigue.; This is... Read more
pain all over my body; pain left arm pit; pain in my left breast; Some chill; very fatigue.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; (Lot Number: EP6955) via an unspecified route of administration in the arm left on 30Mar2021 at 12:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had a history of allergy to penicillin. Concomitant medications included levothyroxine 100mcg (MANUFACTURER UNKNOWN) from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247,) via an unspecified route of administration in the arm left on 09Mar2021 at 09:45 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 00:15, after 12 hours of the second dose, the patient experienced general body pain, the left arm pit area and left breast (injection arm) and had 8/10 level of pain, chills and very fatigue. The patient did not received any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events general body pain, armpit pain, breast pain, chills and fatigue was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
46 2021-07-19 burning sensation very tired, rash on belly and back, shingles severe burning and itching
46 2021-07-19 tremor, feeling cold Pt stated she was shaking and cold after getting vaccine. Nurse gave her water and took vitals Heart... Read more
Pt stated she was shaking and cold after getting vaccine. Nurse gave her water and took vitals Heart rate was 117. About 30 minutes later pt wanted us to call the EMS. EMS said vitals were normal and cleared her.
46 2021-07-20 feeling cold on the night of 4/7 100.9 fever, sweating, nausea, chills, headache, fatigue went on for about two d... Read more
on the night of 4/7 100.9 fever, sweating, nausea, chills, headache, fatigue went on for about two day and everything except horrible sweating, tasted vaccine
46 2021-07-20 hypersensitivity of all senses, burning sensation, pain in extremity, tingling I ended up having really bad itching in my head and scalp, palms, and on my head. It went to my feet... Read more
I ended up having really bad itching in my head and scalp, palms, and on my head. It went to my feet and hands. They burned really bad. There was pain and then my skin was sensitive all over. Like pinching needles. That has worsen tremendously. I have Blood Pressure now. I have never had Blood Pressure before. Its mainly just the pain in my hands and legs and burning and high blood pressure. I do not have itching anymore it just comes and goes now. I went to the doctor the second week of May with my PCP and she sent me to an immunologist and allergy doctor. The allergy doctor sent me to the neurologist. They sent me to the ER. Then I went to the cardiologist. The cardiologist sent me to the dermatologist. I had a biopsy to see what is going on with my hands. They have done ENG test, electrocardiogram, blood work, pretty much everything. Everything came back normal.
46 2021-07-21 weakness, pain in extremity large bump under her armpit; Her chest is swelling; chest pain; shortness of breath, difficulty brea... Read more
large bump under her armpit; Her chest is swelling; chest pain; shortness of breath, difficulty breathing; Has a headache; Lymphadenopathy in ears and throat; Left foot hurts right under the knee; Joint pain and inflammation; joint pain and inflammation; She has been feeling really bad; Her hand is swollen; Breast on side of bump under the armpit is inflamed and hurts; Lumps behind her ears, in her groin, and in her hands; Throat and neck hurt and look swollen; Throat and neck hurt and look swollen; Left side of her back and all of this hurts; Her face was swollen and her eyes and head hurt; her face was swollen and her eyes and head hurt; her face was swollen and her eyes and head hurt; itching and she had it on the bottom of both feet; exhausted and tiredness; dizziness and nauseous; dizziness and nauseous; lump at vaccine site; she felt like vomiting and vomited a couple of times; Diarrhea; fever; weakness; first vaccine 23FEB2021 and second vaccine 29JUN2021; first vaccine 23FEB2021 and second vaccine 29JUN2021; eyes swollen and can not see well; This is a spontaneous report from a contactable consumer or other non hcp. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 29Jun2021 (Batch/Lot Number: EW0179) as dose 2, single for covid-19 immunization. Medical history included ongoing thyroid disorder, hypertension, diabetes mellitus, kidney infection from an unknown date she went to the hospital 3 weeks ago, to the emergency room, because of a kidney or urine infection and it still hurts, but they still hurt at the time of report, allergy to vaccine from 23Feb2021, allergic to first dose: ongoing asthma. The patient received first dose of bnt162b2 on 23FEB2021 via an unspecified route of administration (Batch/Lot Number: EL9266) as dose 1, single for covid-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced large bump under her armpit, chest was swelling, chest pain, shortness of breath, difficulty breathing, headache, and lumps behind her ears, in her groin, and in her hands; throat and neck hurt and look swollen, left side of her back and all this hurts and it was right under the knee. Her left foot hurts. She had joint pain and inflammation. She had been feeling bad and she had been several days with these symptoms. Also, her hand was swollen, breast on side of bump under the armpit is inflamed and hurts, she said that the large bump was under her armpit started first. Face was swollen and her eyes and head hurt. Caller again states that the lump was in her hand, there was the chest, and her back, and it hurts to breathe, and she inhaled a spray that she had for asthma. She noticed there was the itching and she had it on the bottom of both feet all the way up to her feet. Itching and she had it on the bottom of both feet. she was applying ointment and was scratching and there was some inflammation like when someone has allergies and starts scratching but it was the bottom of her feet, she suffered from allergies and she thought it was that but that was what she had the previous day. she felt exhausted and tiredness, dizziness and nauseous. She said her arm where she received the vaccine on, she never had pain on the side of the vaccine, but then she started on a lump on Wednesday, there was pain and itchiness and swelling as previously captured. She felt like vomiting and vomited a couple of times, she had diarrhea and fever. she did not feel like getting up because of the weakness and chest pain, and then that was when she noticed the right-side breast kind of bulky and swelling and then the lump got larger. Her Eyes swollen, she put on her glasses because she could not see well because her eyes were swollen. she was outside the ER right now and had not stepped in yet because of the questions she was answering. she had been taking Naproxen for the pain and using ice packs. She had inflammation very strong in joints, swollen hand and had felt bad for days. She states she is still experiencing shortness of breath, and she feels exhausted and tiredness, dizziness and nauseous, and a headache. Caller was asked regarding symptoms improving, worsening, or persisting and states that just yesterday and today early this morning and before dawn she started to feel different. The patient received treatment for the events. The outcome of the events was Unknown. Information on the lot/batch number has been requested.
46 2021-07-21 numbness, inability to speak Within 24 hour, high fever 102 and body aches that lasted for 6 days. On Jan 12, 2021 contacted COVI... Read more
Within 24 hour, high fever 102 and body aches that lasted for 6 days. On Jan 12, 2021 contacted COVID line, recommend rest and fluids, no recommended to Test for COVID. After fever reduced, rash on both legs appeared approx Jan 18th. On Feb 2nd Went to Express care after this rash didn't go away. Was told it was exzcema given Kenalog cream and Atarax and to follow up with PCP if not better in 10 days. Sent message to PCP with photos of rash and recommendation. Referal completed for Dermatology. Had appt on Feb 22 but rash had cleared up prior to appt. Was advised to call if reappeared. Approx April 13 rash reappeared. Used Kenalog as before but no difference. On April 20, 2021 Contacted Dermatologist was advised to continue using kenalog. On April 22 contacted Dermatologist again to advise that rash is getting worse and had spread more to thighs rather than just lower leg area. Was prescribed betamethasone dipropionate .05% ointment. April 23 rash remained the same, experienced swelling in lower extremities. towards evening lower calves were swollen to same size as thighs. Asked husband to take me to express care. On the way to express care, i began experiencing numbness on the right side of my body and was taken to Emergency Room. At the emergency room, began having trouble formulating words. Was worked up for possible stroke. Stroke was ruled out but no answers as to why i experienced the stroke like symptoms. Rash was examined and prescribed prednisone and follow up with Dermatology on April 26. Met with Dermatology on April 26 and a biopsy was performed resulting in diagnosis of dermal hypersensitivity reaction. Over the course of the next few weeks, I had swelling off and on in my legs like what lead me to the emergency room on April 23 but no rash was present. I made contact with PCP on May 19th to advise of the swelling and was requested to come to the office. As a result of the office visit, an ultrasound was requested of my right leg which indicated a DVT. I have since started blood thinners and continue to follow up with providers as necessary.
46 2021-07-21 muscle spasms Menstruated a week early; Extreme cramping; Period stopped then started again; PMDD symptoms; This i... Read more
Menstruated a week early; Extreme cramping; Period stopped then started again; PMDD symptoms; This is a spontaneous report from a contactable consumer(patient) reported for herself that. A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:00(Age at Vaccination: 46) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient past Medical history included Pyridium Allergy, Sulfonamide allergy, migraine, ongoing premenstrual dysphoric disorder PMDD, bipolar disorder, Bipolar NOS, attention deficit hyperactivity disorder and osteoarthritis. Concomitant medication included erenumab aooe (AIMOVIG), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion (BUPROPION), trazodone (TRAZODONE). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. the patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 22Apr2021 at 13:00, the patient experienced Menstruated a week early one day after second shot, Extreme cramping, period stopped then started again and PMDD symptoms won't go away. The patient is treated with Toradol injection. The event outcome was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
46 2021-07-21 pain in extremity Minor arm pain; Extreme middle & low back pain; Hip Pain; This is a spontaneous report from a contac... Read more
Minor arm pain; Extreme middle & low back pain; Hip Pain; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm left on 30Mar2021 at 12:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, back pain, sacroiliitis, herniated disc and muscle spasms. Concomitant medications included sitagliptin phosphate (JANUVIA), valaciclovir hydrochloride (VALTREX), empagliflozin (JARDIANCE) and glipizide (GLUCOTROL) all from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, at 05:00 the patient experienced minor arm pain, extreme middle & low back pain and hip pain. The patient received pain meds as a treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events minor arm pain, extreme middle & low back pain and hip pain was recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
46 2021-07-21 pain in extremity After the second dose I had fatigue and arm pain so bad I could not do anything with that arm for li... Read more
After the second dose I had fatigue and arm pain so bad I could not do anything with that arm for like a week. Then it was gone. 2 weeks after things got really bad in a weird way. I went to a constant period where I only had a couple of days where I was not in my period. In May I ended up getting an infection, which was bacterial vaginosis and I went to the doctor around the 12 or 13, he prescribed me Clindamycin. The infection went away. Last month I got bacterial vaginosis, yeast infection, and constant period. I am not sexually active. I had just been in November to the doctor and been healthy in that area. I made an appt with the OBGYN on the 07/26 so I have not seen the specialist yet. A couple of days after making the appt I went to urgent care, Urgent Care because the pain was so bad, when they looked in there they said it was hard to see because of the blood. They said it looked like bacterial vaginosis and yeast infection and gave me metrogel and it also looked like an abnormality in there. They tested for bacterial vaginosis and yeast infection and said it was negative, and they did not have any idea of what was going on. I took the whole antibiotics and they went away for about a week and now is back again and my period came back again. It was 10 days without having the period. After the second dose when it got worse I am also in a support group for perimenopause women and a woman reported she also had the same symptoms as I did. They also did blood work at urgent care and it was normal. They were worried about the amount of blood that I lost.
46 2021-07-21 unresponsive to stimuli Site: Swelling at Injection Site-Severe, Systemic: Abdominal Pain-Mild, Systemic: Fainting / Unrespo... Read more
Site: Swelling at Injection Site-Severe, Systemic: Abdominal Pain-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild
46 2021-07-22 migraine Intractable migraine; vertigo; irregular menstrual cycles afterwards; nausea; fatigue; low blood pre... Read more
Intractable migraine; vertigo; irregular menstrual cycles afterwards; nausea; fatigue; low blood pressure; new muscle tightness in left shoulder and left neck; moderate anemia
46 2021-07-22 pain in extremity, nerve pain, numbness, tingling scar inflammation, joint pain/stiffness, nerve pain in upper extremities, and numbness/tingling in u... Read more
scar inflammation, joint pain/stiffness, nerve pain in upper extremities, and numbness/tingling in upper and lower extremities
46 2021-07-23 bell's palsy Bell?s palsy
46 2021-07-24 pain in extremity Extreme soreness in right arm/shoulder area kicked in immediately and lasted for about four days
46 2021-07-25 tingling, numbness About 40 minutes post-vaccine, patient experienced numbing sensation in both sides of face. Numbnes... Read more
About 40 minutes post-vaccine, patient experienced numbing sensation in both sides of face. Numbness continued and then spread to the outer right thigh and calf. Numbness in face started improving after a few days, but reoccurred several weeks post-vaccination. Numbness. tingling sensation in leg transferred to left leg, and was intermittent. Patient experienced tightness in chest 36 hours post-vaccination, but upon seeking medical attention, no heart attack or stroke was present. Numbness has continued for 8 weeks post-vaccine. Paralysis has not occurred and patient has full mobility of facial muscles and limbs.
46 2021-07-26 flushing Patient had vasovagal syncopal event shortly after administration. Felt flushed immediately after sh... Read more
Patient had vasovagal syncopal event shortly after administration. Felt flushed immediately after shot and was seated for about 5 minutes. She tried to stand up and slowly fell forward to the ground. Pharmacist and patient's husband responded immediately. Patient woke up on floor almost right away. She had some water and was monitored for another 20 minutes before she left by her own choice.
46 2021-07-26 numbness July 26 2021 lower lip was numb twice, July 27, 2021 nose was numb twice.
46 2021-07-27 discomfort, pain in extremity Left arm pit accompanied by pain and discomfort.; Left arm pit accompanied by pain and discomfort.; ... Read more
Left arm pit accompanied by pain and discomfort.; Left arm pit accompanied by pain and discomfort.; Severe swelling of the lymph node; Fever of 37.9; Severe pain in left arm; This is a spontaneous report received from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162B2 (COVID-19 VACCINE-MANUFACTURER UNKNOWN; Lot Number: ew0151), via an unspecified route of administration in the arm left on 01Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 prior to vaccination on an unspecified date. The patient had history of known allergies to nickel. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL); all from an unknown dates taken for unknown indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced left arm pit accompanied by pain and discomfort on 02Apr2021, at 16:00 with outcome of recovering, severe swelling of the lymph node on 02Apr2021, at 16:00 with outcome of recovering, fever of 37.9 on 02Apr2021, at 16:00 with outcome of recovered on 04Apr2021, severe pain in left arm on 02Apr2021, at 16:00 with outcome of recovering. Details were as follows: on 02Apr2021 at 16:00, 24 hours following the injection, the patient experienced fever of 37.9 which lasted for almost two days. Severe pain in the left arm. Severe swelling of the lymph node in the left arm pit accompanied by pain and discomfort were noted. The lymph was visibly swollen 4 days after the injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the left arm pit accompanied by pain and discomfort, severe swelling of the lymph node and severe pain in left arm was recovering; fever of 37.9 recovered on 04Apr2021. Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities. No follow-up attempts are possible. No further information is expected.
46 2021-07-27 flushing Itching on chin, jawline and cheeks; cheeks would flush with the itching; This is a spontaneous repo... Read more
Itching on chin, jawline and cheeks; cheeks would flush with the itching; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in the left arm on 27Mar2021 at 09:15(at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy(sulfonamide allergy). The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 10:00 after 45 min of vaccination, the patient experienced itching on chin and itching continued mostly on chin, jawline and cheeks for 7 days. Occasionally her cheeks would flush with the itching. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported events which included antihistamines. The clinical outcome of the event itching and flush were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
46 2021-07-27 numbness, electric shock sensation right foot Numbness; Severe fatigue; Numbness left arm and right hand.; Electric shock sensations up... Read more
right foot Numbness; Severe fatigue; Numbness left arm and right hand.; Electric shock sensations up arms and legs; headache; cognitive issues; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female non pregnant patient reported for herself that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM6200), via an unspecified route of administration, administered in right arm on 29Mar2021 at 08:00 AM (vaccinated at the age of 46 years) as DOSE 1, SINGLE and received second dose via an unspecified route of administration, administered in left arm on 19Apr2021 at 08:00 AM (Batch/Lot Number: EN6955) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnancy at time of vaccination. The patient medical history was not reported. Concomitant medications included amlodipine, estrogens conjugated and citropram; all were taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. Not received any other medications in four weeks. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, the patient experienced numbness left arm and right hand. Electric shock sensations up arms and legs right foot Numbness headache severe fatigue cognitive issues. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events with unknown medication as per neurologist referral. The patient did not had covid prior vaccination and did not got covid tested post vaccination. The report was non serious. Outcome of the events was unknown.
46 2021-07-27 pain in extremity, tingling My hands were weak and tingly as if I had nerve damage. I wasn't able to open a bottle of water. I h... Read more
My hands were weak and tingly as if I had nerve damage. I wasn't able to open a bottle of water. I had a hard tome gripping things. My hands felt right and sore for days after the 1st shot. And again with the 2nd shot. Also, after the 2nd shot the next day I had a strange sharp chest pain and other odd feelings that lasted on and off for couple of hours.
46 2021-07-27 pain in extremity Right leg swelling, right arm ached and I had a headache on my right side, nausea and chills, and fe... Read more
Right leg swelling, right arm ached and I had a headache on my right side, nausea and chills, and felt very tired. I went to the hospital and got an IV, I had 186 blood pressure. I was there for 9 hours. My blood pressure went down to 176/100 and left to go home. I did not receive any medication for leg and arm pain but did get a shot for the pain. I was referred to a primary doctor.
46 2021-07-27 tingling Headache; Piercing pain on injection side and a few other spots in thighs and legs; Rapid heart rate... Read more
Headache; Piercing pain on injection side and a few other spots in thighs and legs; Rapid heart rate; Tingling in the back of both hands; Extreme tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 05Apr2021 at 18:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Patient has no medical history. Past drug history include pork and its derivatives and bees Concomitant medications included ibuprofen (ADVIL) ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), zinc lactate (ZINC) and birth control pills (unspecified) all taken for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 18:30 the patient experienced headache, piercing pain on injection side and a few other spots in thighs and legs all within 15 minutes of vaccine. Patient also experienced extreme tiredness and what felt like rapid heart rate for 2-3 days following vaccine. The clinical outcome of the event headache, piercing pain on injection side and a few other spots in thighs and legs, extreme tiredness and tingling in the back of both hands was resolved on an unknown date in 2021; while that of rapid heartrate was resolved on an unknown date in Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-07-28 inability to speak For 48 hrs after second shot - INTENSE brain fog. Thought I had given myself Alzheimer?s. Couldn?t f... Read more
For 48 hrs after second shot - INTENSE brain fog. Thought I had given myself Alzheimer?s. Couldn?t form thoughts or sentences properly. Fever of 102 on Tylenol. Eventually subsided. THEN: My periods are regular every four weeks. Two weeks after second shot, I skipped my period. Feb - skipped March - skipped April - started two weeks early May - started one week late June - started regular July - started regular
46 2021-07-28 numbness Throat Swelling internally, Stiff neck, Trouble swallowing, Facial numbness, Rapid heart, tight ... Read more
Throat Swelling internally, Stiff neck, Trouble swallowing, Facial numbness, Rapid heart, tight chest
46 2021-07-28 pain in extremity Aching like arthritis in my knees and legs; Aching like arthritis in my knees and legs; This is a sp... Read more
Aching like arthritis in my knees and legs; Aching like arthritis in my knees and legs; This is a spontaneous report from a contactable physician, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 11Mar2021 at 08:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID), taken from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, approximately one week after vaccination, the patient experienced aching like arthritis in the knees and legs which had lasted approximately two weeks. It was reported that the patient never had arthritis before. The clinical outcome of the event aching like arthritis in the knees and legs was resolved on 01Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
46 2021-07-28 pain in extremity Left arm pain persists and not resolve after a few months; This is a spontaneous report from a non-c... Read more
Left arm pain persists and not resolve after a few months; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El3249) via an unspecified route of administration in the arm left on 22Jan2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685) via an unspecified route of administration in the arm left on an unspecified date (unspecified age), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was tested for COVID-19. On 25Jan2021, the patient experienced left arm pain. The pain persisted and not resolved after a few months, still had the pain when the arm was moved backwards and up at the time of this report. No therapeutic measures were taken as a result of the event. On an unknown date, the patient underwent SARS-CoV-2 test through nasal swab and the result was negative. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event left arm pain was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
46 2021-07-28 tenderness Swelling/soft lump under left arm pit; Tender to touch; This is a spontaneous report from a contacta... Read more
Swelling/soft lump under left arm pit; Tender to touch; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP8732) via an unspecified route in left arm on 02Apr2021 at 12:00 (at the age of 46-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The medical history of patient included Crohn's disease. Concomitant medications included rosuvastatin calcium (CRESTOR), glucosamine (MANUFACTURER UNKNOWN), mesalazine (LIALDA) and mesalazine (CANASA) started on an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route in left arm on 12Mar2021 at 09:30 hours as single dose for COVID-19 immunisation. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 03Apr2021 at 20:00, the patient had swelling/soft lump under left arm pit and tender to touch. No treatment was given for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swelling/soft lump under left arm pit and tender to touch was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2020-12-31 numbness, facial paralysis Ever since I got the vaccine I have headaches which increased to near migraine level on 12/29, then ... Read more
Ever since I got the vaccine I have headaches which increased to near migraine level on 12/29, then yesterday 12/31 at 330pm while painting my left face became paralyzed and numb. Went to ER Had CT/CTA of head EKG, chest Xray and multiple labs including Lyme test which will not be resulted for 5-7 days. ER started me on taper prednisone and doxycycline. Diagnose with significant Bell's Palsy
47 2020-12-31 tenderness Left side area of spleen, splenomagaly to palpation. Dull ache, increased pain on inspiration, sharp... Read more
Left side area of spleen, splenomagaly to palpation. Dull ache, increased pain on inspiration, sharp pain to palpation.
47 2021-01-02 weakness dizziness weakness headache neck pain
47 2021-01-03 inability to speak Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breat... Read more
Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breathing got worse, called 911, 1 Epipen given, she started to cough and talk to us, then couldn't breathe again, couldn't talk, paramedics arrived.
47 2021-01-03 depressed level of consciousness 12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out m... Read more
12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out my heart was beating really hard, it started to mellow out and my face swelled up about an hour after. I was told to go to the ER and I took oral Benadryl and it went away and did not return
47 2021-01-03 flushing EE presented to EH with c/o hives to face and racing heart rate at 1445
47 2021-01-03 migraine, pain in extremity Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise ar... Read more
Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise arm without significant pain), left wrist pain
47 2021-01-03 tingling, pain in extremity Initial 36 hours sore at injection site Day #4 pain in hip joints and moderate aching in legs bilate... Read more
Initial 36 hours sore at injection site Day #4 pain in hip joints and moderate aching in legs bilaterally Day #5 prickling needles feeling soles of feet bilaterally and palms of hands for short time. Palms have resolved. Soles of feet remain on Day #6.
47 2021-01-04 weakness Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip p... Read more
Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included sick with coronavirus infection from 11Aug2020. There were no concomitant medications. The patient was experiencing the expected side effects fever, feels weak, tired, lightheaded, pain at the injection site in the right deltoid, hip and back joint pain on Dec2020. She does not know exactly when these events started but that she noticed them when she was trying to sleep last night. Outcome of the events was not recovered. The events were considered serious due to being medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162b2 and the events pyrexia, asthenia, fatigue, dizziness, vaccination site pain, back pain and arthralgia cannot be excluded.
47 2021-01-04 feeling cold Felt tired and cold Fever
47 2021-01-04 flushing, feeling hot, tingling At time of injection and for about 30 minutes after, had light tingling to left arm to fingertips, f... Read more
At time of injection and for about 30 minutes after, had light tingling to left arm to fingertips, face flushed and warm. Resolved without intervention. No other side effects except muscle soreness to this arm. ( Wouldn't report but a coworker had a similar but more severe reaction and is still having effects 3 wks out)
47 2021-01-04 flushing Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light hea... Read more
Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light headed. She was alert and oriented x 3. V/S: 120/72; pulse 140; resp 22; O2 sat 99% on RA; pupils equal and reactive; skin pink. Dr was notified and assessed the employee. Dr. ordered Benadryl 25mg PO which was administered at 1050. 1120 - o2 sat was 98% on RA; pulse 85; employee reported that chest tightness resolved and light headedness impoved, but not resolved; she continued to be flushed. Symptoms continud to improve. Employee remained in the observation area and was instructed to seek emergency treatment if symptoms returned, worsen or new symptoms occured. She verbalized understanding.
47 2021-01-04 flushing high heart rate, blotchy/flushed skin, urticaria
47 2021-01-04 numbness Right facial numbness; This is a spontaneous report from a contactable other healthcare professional... Read more
Right facial numbness; This is a spontaneous report from a contactable other healthcare professional. A 48-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration on 16Dec2020, 18:00 at single dose (dose 1, reported as right arm, and also reported as left arm) for COVID-19 immunization. Medical history included DM, hypothyroid, and HTN from an unspecified date. The patient's concomitant medications were not reported. No other vaccines were given in four weeks. Patient has no COVID prior vaccination and did not undergo COVID testing post vaccination. The patient has no known allergies. The patient experienced right facial numbness on 16Dec2020 19:00, also reported as 50 minutes after receiving the vaccine. She was instructed to take one dose of BENADRYL as treatment. It was reported that numbness last for about 2.5 hours. Outcome of the event was recovered on 16Dec2020. The event was reported as non-serious.
47 2021-01-04 pain in extremity 12/28 - 2 hours after injection - terrible arm pain. Could not raise arm and felt like a pulled musc... Read more
12/28 - 2 hours after injection - terrible arm pain. Could not raise arm and felt like a pulled muscle from my neck all the way down arm. This went on for 4 days. The pain woke me up at night for 2 nights. Just took Ibuprofen. This pain has resolved. 12/29 - body aches, chills, joint pain, fatigue, SOB on exertion, runny nose, and sneezing. These symptoms went on for 5 days. Mostly resolved - still some fatigue and SOB on exertion, runny nose, and sneezing. Again, treated with ibuprofen and rest. 1/31 - Extreme nausea, aggitatation, and fatigue. Took Zofran and went to bed at 7pm and slept until 9am. Felt much better. 1/2 - Completed a virtual visit. Advised to come in to clinic for covid test only. Not seen by physician. Negative results, and no F/U from a provider. 1/5 - All symptoms resolved except some fatigue and SOB on exertion, runny nose, and sneezing.
47 2021-01-04 pain in extremity All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My ... Read more
All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My left arm started swelling, it started in fore arm and it started getting marks on it; pain in arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in her right arm on 21Dec2020 at single dose for covid-19 immunization. Medical history included Blood pressure high, Attention deficit hyperactivity disorder (ADD), depression and cancer four years ago and she didn't have any left node in left arm. Concomitant medications included losartan (LOSARTAN) for Blood pressure high, venlafaxine hydrochloride (EFFEXOR) as antidepressant, tamoxifen (TAMOXIFEN) for her cancer and it was hormone blocker, lisdexamfetamine mesilate (VYVANSE) for ADD. The patient received the vaccine last this last Monday on 21Dec2020, in her right arm, she was fine, on Thursday on 24Dec2020 like all of sudden she started feeling bad, she mean it just hit her. She had fever, she was very nauseous and her arm, her left arm started swelling, it started in forearm and it started getting marks on it. Anyway she went go and got tested for Covid yesterday 26Dec2020 because in middle of night, that night I felt so bad. She have got just headache on 24Dec2020, its most of that before then. Anyways she had just got her results back that was negative but so she didn't know that her arm, it was the opposite arm. The patient still experiencing pain in arm, she haven't had fever in last night and she haven't checked it today. She took Tylenol and she called her doctor yesterday and they made of me some antibiotics for her arms, probably the 7mg and the patient guess it is every 8 hours. The outcome of the event pain in arm was not recovered and the outcome of the other events was unknown. Information on the lot/batch number has been requested.
47 2021-01-04 tingling Pt reported itchiness and tingling on her neck and back around 20 minutes after receiving vaccine. P... Read more
Pt reported itchiness and tingling on her neck and back around 20 minutes after receiving vaccine. Pt given 25 mg of diphenhydramine tab, and she refused 2nd diphenhydramine tab. Pt reported cessation of itchiness and tingling 20 minutes after receiving diphenhydramine.
47 2021-01-05 weakness Chills, fever, general weakness & fatigue, sweating
47 2021-01-05 flushing, tingling, feeling hot Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain... Read more
Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain, no palpitations, no tongue swelling, no rash, no redness, no nausea, vomiting or lightheadedness, no diaphoresis, no Hives improved in 1 hour and with Benadryl
47 2021-01-05 tingling, weakness Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous ... Read more
Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC1284), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced extreme fatigue, tingling in arm that was vaccine was given, fever, and weakness on 30Dec2020. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.
47 2021-01-05 tingling Patient states that about 5 minutes after vaccine they felt "pins and needles" sensation in their le... Read more
Patient states that about 5 minutes after vaccine they felt "pins and needles" sensation in their left arm and hand. Covid vaccine was given in left deltoid. Patient waited 30 minutes after vaccination with no new symptoms. Patient denies the need for any further medical attention. Patient left with a companion.
47 2021-01-06 feeling hot, flushing Dizziness, UrticariaPruritus, HYPERtension, facial flushing, face felt warm
47 2021-01-06 flushing Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 ... Read more
Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 days ago on 12/22. Patient also reporting flushing, intermittent tachycardia, and headache x2 days. Vitals were taken and follow: blood pressure 108/117, heart rate 111, spO2: 100%. Injection site observed to be red and tender. Patient reports history of allergies to tetracaine. Patient did not take medication OTC prior to coming in to clinic. Patient was transferred and admitted to the emergency department. In the emergency department was given benadryl and monitored for symptom improvement. Was discharged on the same day.
47 2021-01-06 tingling Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins a... Read more
Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins and needs sensation. This was followed by some swelling. Improved over 24 hours. Still feeling "tight" in knuckles.
47 2021-01-06 tremor Shaking chills, myalgia and bone pain
47 2021-01-07 burning sensation dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 h... Read more
dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself. A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
47 2021-01-07 difficulty speaking After 15 mins I felt like I couldn't breath. On the way home hour later hard to breath. I went to ER... Read more
After 15 mins I felt like I couldn't breath. On the way home hour later hard to breath. I went to ER gave me Steroids and Pepcid. Since then I have taken Benadryl. On 12/30 at 10am I was exp reaction again went back to the ER. They provided me with breathing treatment and was sent home on Prednisone. I contacted my PCP to inform her that I have to continue taking Benadryl to help with sob and my voice changes. It seems like my lungs are affected due to taking the vaccine. I'm currently off and not able to receive comp due to the vaccine being voluntary.
47 2021-01-07 feeling hot, flushing, tingling flushed; small amount of tingling to left hand; face warm; This is a spontaneous report from contact... Read more
flushed; small amount of tingling to left hand; face warm; This is a spontaneous report from contactable consumer (patient). A 47-year-old female patient first dose received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EKS730, intramuscular Left arm from 18Dec2020 16:00 to 18Dec2020 16:00 as single dose for COVID-19 immunisation. Medical history included osteoarthritis. Concomitant medication included paracetamol (TYLENOL), ibuprofen (ADVIL). On 18Dec2020 16:30, immediately after injection, the patient experienced small amount of tingling to left hand, face warm, and flushed, which resolved within 30 minutes without intervention. The outcome of the events was recovered. No treatment was received for the events.
47 2021-01-07 feeling hot Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I r... Read more
Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I received a rash over the arm in which I had the injection. Since the shot Monday, I have continued to have redness on neck and face and along with felling hot. I have been taking Benadryl since Monday and finally went to UC on Thursday 01/07/2021. At the appointment, I received a Decadron injection, which helped, but today I am back to red face/neck and warmth.
47 2021-01-07 flushing, flushing 12 minutes, first vaccine reported tingling to the tongue, cheeks flushed, progression to feeling li... Read more
12 minutes, first vaccine reported tingling to the tongue, cheeks flushed, progression to feeling like throat was swelling. Patient was taken to ED via wheelchair. Monitoring and BP @7:40 135/83 HR 72 Resp. 18. Under oBS at hospital, not admitted. *Initial dose reported symptoms of feeling sick with dose 1 but not to extent of second dose
47 2021-01-07 flushing Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontan... Read more
Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 07:00 at single dose on left arm for COVID-19 vaccination. There were no medical history and concomitant medications. The patient previously took flu shot. Vaccination Facility Type was hospital. Patient did not receive any other vaccines at time COVID-19 vaccine given and no vaccines given 4 weeks prior. Patient got the Pfizer COVID-19 vaccine on 29Dec2020 and had an allergic reaction to it. Had hives on her back, was flushed, had chills, and swollen tongue on 29Dec2020. There was swelling on either side of tongue not in the center. Swelling seemed to bounce around sides of tongue. Patient mentioned she also had burning sensation of tongue first on 29Dec2020 and then the swelling was after that. Adverse events hives, flushed, chills, burning sensation of tongue and swelling of tongue required a visit to emergency room. Patient was seen in the emergency room and given diphenhydramine hydrochloride (BENADRYL) and an Epi-pen to take home. This all happened after receiving the vaccine on 29Dec2020. Patient wasn't getting any better/feeling better and went back to the emergency room on 30Dec2020. Patient was treated with dexamethasone and told her to take diphenhydramine hydrochloride every 4 hours, her last dose was at 2pm 31Dec2020. Patient said all events still persisting, but there maybe a little more swelling of the tongue, but not much. Patient had had a flu shot before, but never had anything to happen like this. Outcome of allergic reaction, hives, flushed, chills and burning tongue was not recovered, outcome of swollen tongue was unknown. Information on the lot/batch number has been requested.
47 2021-01-07 numbness Numbness on the left side of the face; This is a spontaneous report from a contactable physician (pa... Read more
Numbness on the left side of the face; This is a spontaneous report from a contactable physician (patient). A 47-year-old non-pregnant female patient received the first dose bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1284), via an unspecified route of administration on 22Dec2020 at 14:00 at single dose in left arm for covid-19 immunization. Medical history included trigeminal neuralgia. Concomitant medication included colecalciferol (VITAMIN D) and multivitamin. The patient experienced numbness on the left side of the face on 22Dec2020 at 16:00, started within 2 hours of the shot and had continued for 2 weeks. The event was reported as non-serious by reporter. The patient didn't receive treatment for the event. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID 19 prior to vaccination, and was not tested for COVID 19 since vaccination. The outcome of the event was not resolved.
47 2021-01-07 pain in extremity Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; He... Read more
Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; Headache; Feeling sluggish and unwell; Feeling sluggish and unwell; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at right arm on 28Dec2020 10:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. Concomitant medication included Alive multivitamin which received within 2 weeks of vaccination. The patient experienced soreness at injection site and entire upper arm, headache, feeling sluggish and unwell, all on 28Dec2020 16:00. No treatment received. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. This is a non-serious report. The outcome of the events was recovered on an unspecified date.
47 2021-01-07 tingling, pain in extremity Prickling needles feeling soles feet bilaterally and some in palms hands; pain in hip joints; modera... Read more
Prickling needles feeling soles feet bilaterally and some in palms hands; pain in hip joints; moderate leg aches bilaterally; Sore arm at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm, on 30Dec2020 at a single dose for COVID-19 immunization. The patient was 47 years old when she received the vaccine. Medical history included RSD (Reflex sympathetic dystrophy), had allergies to medications, food, or other product particularly NSAID and to contrast dye. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. She had not been tested for Covid-19 since vaccination. The patient had sore arm at injection site for 36 hours after administration (02Jan2021) with outcome of recovered in Jan2021. In day #4 (03Jan2021), she had pain in hip joints and moderate leg aches bilaterally with outcome of unknown. In day #5 (04Jan2021), she had prickling needles feeling soles feet bilaterally and some in the palms of her hands with outcome of unknown. The events were reported as non-serious. No follow-up attempts are possible. No further information is expected.
47 2021-01-07 tingling Pt report bilateral cheek tingling. Treatment include Benadryl,
47 2021-01-07 tingling Throat flem, body tingles, EMS screened, increased observation time, resloved in 15 min
47 2021-01-08 breast pain, hot flush 1 of 2, Pfizer-BioNTech COVID-19 Vaccine EUA received 1/7/21. Got hot flashes/sweaty, headache, left... Read more
1 of 2, Pfizer-BioNTech COVID-19 Vaccine EUA received 1/7/21. Got hot flashes/sweaty, headache, left chest/breast pain, fatigue, stuffy nose.
47 2021-01-08 numbness She initially developed and numbness of her face (both sides). This started in about 15 - 30 minutes... Read more
She initially developed and numbness of her face (both sides). This started in about 15 - 30 minutes after the vaccine and lasted about 2 hours. She had no facial muscle issues. She then developed intense vertigo and nausea. I question possible vestibular neuritis. This lasted about 5 days and was more severe the first 3-4 days. At day 7 she was almost back to normal. She also had a frontal tension style headache
47 2021-01-08 tingling, flushing Arms started tingling immediately after injection but did not think it was a significant response. A... Read more
Arms started tingling immediately after injection but did not think it was a significant response. As I was driving home my throat began to swell, my heart was racing, my chest got red and I was very shaky - this occured appx 50 minutes post injection.
47 2021-01-08 speech disorder About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did... Read more
About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did not seem affected by the fatigue but my brain/head felt very "fuzzy". I had a hard time getting words out. Similar feeling to etoh intoxication. I was a bit off balance and dizzy. I remember shaking my head to try to clear it. I also had a very"plastic" taste in my mouth and felt nauseous. At the 48 hour mark (almost exactly) I felt better. At 60 hour mark brain/head symptoms completely resolved. Only experienced a very slight nauseated feeling.
47 2021-01-10 weakness, mild one side paralysis vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can o... Read more
vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can only say it is what I would imagine restless leg syndrome might feel like, weak and achy that disrupted sleep all night. 12/28/20 noticed enlarged lymph node on left side near clavicle tender to touch
47 2021-01-10 feeling cold ? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to... Read more
? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to becoming numb ? elevated BP
47 2021-01-10 numbness, tingling c/o tingling and numbness down length of left arm (site of covid vaccine) extending to finger tips -... Read more
c/o tingling and numbness down length of left arm (site of covid vaccine) extending to finger tips - per physicians consideration: patient should continue to watch or any signs of swelling, redness, and/or soreness. Tingling/numbness possibly due to hitting a nerve.
47 2021-01-10 nerve pain, facial paralysis ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consume... Read more
ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consumer reported for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EK5730; dosage form: injection) via an unspecified route of administration as injection to left arm on 24Dec2020 at 7:30 am at a single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included slight hypertension from Jul2020 and ongoing. Concomitant medications included lisinopril from Jul2020 and ongoing for slight hypertension. The patient developed ball palsy, facial dropping which did not lasted long but she still had the painful shingles on 27Dec2020, after the first dose. She wanted to know the recommendations for taking the second dose which is due in 10 days. The patient wanted to know if she should receive the shingles vaccine. This caller was a lab tech who works in the healthcare industry and manages a medical office; but clarified she did not call on behalf of a healthcare professional. She was the patient who received her first dose of Pfizer SARS-CoV-2 Vaccine on 24Dec2020. She reported onset of what the Urgent Care Physician believed was Shingles on 27Dec2020. She called to ask if she should or should not receive the second dose of Pfizer SARS-CoV-2 Vaccine on 14Jan2021 as scheduled due to the Shingles. The Urgent Care Physician advised her to still get the second dose, as there was about a 1:10,000 chance of developing shingles with the vaccine. She reported shingles as a reaction subsequent to the Pfizer SARS-CoV-2 Vaccine. Initially on 27Dec2020 she developed sites of what she thought were canker sores or fever blisters in her mouth which had gotten pretty large and stopped her from being able to eat on 29Dec2020. Then on 30Dec2020 she developed sites on her face which have gotten scarily large; and was causing some deep nerve pain going to her eye and down her chin; the sites felt like lesions on her face with roots. The sites in her mouth were now completely gone; but the sites on her face are ongoing. Now it has kind of taken over her face. She saw the Urgent Care Physician regarding this who believed the sites to be shingles. She had never had fever blisters or shingles before this event. She was still kind of reeling. The report was reported as non-serious. The outcome of event ball palsy/facial dropping was resolved and of shingles was unknown.
47 2021-01-10 pain in extremity, weakness, feeling hot, tremor, tingling Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of... Read more
Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous. Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities. Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness, "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea. Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness injection site.
47 2021-01-10 pain in extremity, weakness I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccina... Read more
I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccination (01/04/2021). It is especially troublesome on my left hand/fingers. It is worse in the morning when I wake up, but it gets better with movement of my arm/hand to complete my normal day activities.
47 2021-01-10 pain in extremity 01:45 I woke with severe soreness and ache over my entire body (8/10), chills, fever 101.5, and thro... Read more
01:45 I woke with severe soreness and ache over my entire body (8/10), chills, fever 101.5, and throbbing excruriating pain in the left arm (10/10). I was barely able to move the left arm, and I could not bend it due to severe pain in the elbow joint. At approximately 0800, I started having diarrhea that lasted for no more than an hour. By noon the soreness and aching had reduced to a moderate pain (5/10). I was able to bend my left arm, but the arm remained sore at the elbow joint until 01/10/2021. By the morning of 01/10/2021, all the symptoms were gone.
47 2021-01-10 seizure Patient had headache, diaphoresis, low blood pressure and seizure. Patient got Tylenol for her head... Read more
Patient had headache, diaphoresis, low blood pressure and seizure. Patient got Tylenol for her headache and was observed for a few minutes. She was offered Benadryl but patient was allergic to Benadryl. She exhibited grand mal seizure twice. The ambulance was called after the second grand mal seizure.
47 2021-01-11 weakness, flushing patient developed occipital headache, backache, flushed sensation, and weakness; has known history o... Read more
patient developed occipital headache, backache, flushed sensation, and weakness; has known history of "MS". pt. given a water, vitals signs taken, and 1st response team called to transport to ED.
47 2021-01-11 weakness, limb paralysis Arm pain and weakness for 10 (ten) days. 600 and 800 mg doses of ibuprofen
47 2021-01-11 weakness Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later... Read more
Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later in the morning, she began to have axilla pain that radiated to her chest on the site she rcvd. the vaccine. On 1/9/21 she had symptoms of weakness, cough & a great deal of fatigue. By Sunday, 1/10/21 she was feeling fine. Patient also had shortness of breath on 1/8 that resolved.
47 2021-01-11 discomfort Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increase... Read more
Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increased; Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increased; pain and inflammation has significantly increased; feels very sharp especially in my hands in my back near my scapula, and my knee joints; My muscles also feel tight in these areas; The pain and discomfort are significantly greater than normal; This is a spontaneous report from a contactable other hcp. This 47-year-old female other HCP (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 30Dec2020 09:00 at single dose on right arm for COVID-19 immunisation. The patient was mostly healthy, no chronic health conditions. No known allergies. Her family had a lot of auto immune disease history. Concomitant medication included paracetamol (TYLENOL), ibuprofen. The patient had mild arthritis joint pain in her hands, and feet that were usually resolved with OTC pain medications. The pain and inflammation has significantly increased since the COVID-19 vaccine injection and felt very sharp especially in her hands, in her back near mhery scapula, and her knee joints. Her muscles also feel tight in these areas. The pain and discomfort are significantly greater than normal. Symptoms were the worst 2-5 days Post injection and have not resolved. All of the events were on 31Dec2020 09:00 and no treatment was received, all considered as non-serious. No COVID tested post vaccination. The outcome of the events was not recovered. Information on the Lot/Batch number has been requested.
47 2021-01-11 feeling jittery, pain in extremity Received first dose COVID vaccine at 6:30am on 1/5/21. Developed redness to face, arms, and chest (l... Read more
Received first dose COVID vaccine at 6:30am on 1/5/21. Developed redness to face, arms, and chest (like a sunburn) at 2pm. Also felt jittery. Spoke to ER physician and advised to take po Benadryl. Took 2 doses before redness cleared. Jitteriness cleared the next day without Benadryl.
47 2021-01-11 flushing Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortnes... Read more
Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
47 2021-01-11 numbness, feeling cold Pt states cool sensation to right side of face and numbness to right hand- EMS evaluated and some re... Read more
Pt states cool sensation to right side of face and numbness to right hand- EMS evaluated and some resolution of cool sensation to face, hand remains numb
47 2021-01-11 numbness tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole f... Read more
tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine. Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
47 2021-01-11 pain in extremity Vaccine administered at 2pm. 1/8/21 @ ~ 4pm LEFT arm soreness (which persisted all evening) 1/9/21 ... Read more
Vaccine administered at 2pm. 1/8/21 @ ~ 4pm LEFT arm soreness (which persisted all evening) 1/9/21 @ ~ 1am I awoke from sleep with worsening LEFT Arm soreness, headache (bad) and body aches 1/9/21 @ ~ 11am Feeling more fatigued, chills, low grade fever 99.9 1/9/21 @ ~ 2 pm, continue to have body aches, fatigue, itchy nose/post nasal drip, chills fever 100.7 1/9/21 @ 8pm continued w/ prior symptoms, developed mild cough ( at this point I felt symptoms may be outside vaccine side effects, honestly wasn't sure if it was seasonal allergies w/ vaccine side effects) 1/10/21 ~ 10 am Awoke feeling better, remained fatigued and with mild intermittent cough but body aches/headaches resolved, opted to go for testing 1/12/21 informed of Covid + test (PCR), was advised by my hospital employee health to complete this form It should be noted I underwent mandated employee testing on 1/5/21 which was negative.
47 2021-01-11 pain in extremity Headache, Sore Arm
47 2021-01-11 pain in extremity Pain in arm to the point patient states they are unable to lift the arm. Patient instructed to foll... Read more
Pain in arm to the point patient states they are unable to lift the arm. Patient instructed to follow up with PCP to have arm visualized and treated if necessary.
47 2021-01-11 pain in extremity Woke up 1/9/21 with pain in my L axilla and swelling. Improved with ice and ibuprofen. Continued t... Read more
Woke up 1/9/21 with pain in my L axilla and swelling. Improved with ice and ibuprofen. Continued to get better of the course of 3 days. No fever but felt ache all over and chills starting 1/8/21 about 8PM, pain in L arm 1/8/21 starting about 2 hours after injection. resolved 1/10/21
47 2021-01-11 pain in extremity tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her a... Read more
tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at 0.3 mL, single for COVID-19 immunization. The patient's medical history included ventricular tachycardia from 2010 and defibrillator in her chest. There were no concomitant medications. She was scared initially so she waited for her coworkers to get the vaccine. Now, she is scared for the second dose. The night after the injection, on 28Dec2020, she had soreness in her arm. It was really bad. After two days, on 30Dec2020, she developed muscle pain, diarrhea, nausea, and headache. On Saturday (02Jan2021), she had an issue with her left eye wherein the eye lid became sore, and it got worse and worse. Her left eyelid was swollen and hurts. Now it is all swollen up. Her eye is not red. The top of the eyelid is so sore. She was really tired initially on an unspecified date. Outcome of the pain in arm and tiredness was unknown, of the swollen eyelid and eyelid pain was not recovered, of the muscle pain was recovered on 31Dec2020, while of the remaining events was recovered on an unspecified date.
47 2021-01-11 tenderness Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of... Read more
Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of voice. Day after vaccination, Severe body pain - back, shoulders, hips, abdomen with Muscle aches, Headache, Mild Discomfort in chest and ribs when breathing, and General feeling of being unwell
47 2021-01-12 weakness, feeling hot feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my ... Read more
feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart; Fast heartbeat; headache; blood pressure went down drastically; tachycardia; weak; looked pale; Anxiety; This is a spontaneous report from a contactable Other HCP (patient). A 47-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included patient was alergic to environmental or insect allergens. No food no medication''. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included loratadine. The patient receive other vaccines within 4 weeks prior to the COVID vaccine was immunotherapy vaccine against mold, insect, mites on 02Dec2020 on both arms. It was reported ''3mins post injection: warm feeling starting on my right arm going down to my left leg. feeling that I was going to pass out. faint. goes and come. I was feeling that I was going to pass out like 3 times , but I was in a wheelchair.. Thanks God and warm feeling from my right leg up to my heart. Fast heartbeat, and weak and sudden headache. Symptoms goes and come. it last 15 mins. Once I was brought to ER.. they estabilize my tachycardia and gave me benadryl. I did get better, but still weak. Stay 2 hours for observation. By the time I got to ER, I was a little better. Physician diagnoses as Anxiety event. because I got estabilize and never got a rash, difficulty breathing. I am 100%, my body for whatever reason it could be, did not welcome the vaccine. and blood pressure went down drastically...i looked pale as they told me.''. Adverse events start date was reported on 18Dec2020 10:03 AM. Case was non-serious. Treatment received for the adverse events included medicine for tachychardia and Benadryl. AE warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart and feeling that I was going to pass out. faint resulted in: [Emergency room/department or urgent care]. The outcome of the events ''warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart'' and ''feeling that I was going to pass out. faint'' was reported as recovered. The outcome of other events was unknown. Information about Lot/batch number has been requested.
47 2021-01-12 feeling hot, flushing Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving... Read more
Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving the dose, she felt warm, flushing and redness in chest area. Patient was brought to ED for evaluation at 9:52am. Treated as allergic reaction, got diphenhydramine 50 mg and famotidine 20 mg. At 11:20am redness was resolving and patient felt better. Her BP was high and got clonidine 0.3mg at 12:18pm. Patient was discharged at 12:31pm
47 2021-01-12 feeling hot 1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79... Read more
1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79, 125/78, O2 Sat 100%, placed supine position 1343: Felt shakey like low BG - got cookies, water, 80 HR, 128/88, 100% O2 1348: Felt like she wanted to sit up. 66 HR, 107/72, 100%, wave of dizziness and nausea 1349: HR 82, 123/86, 100% applied O2 8L Mask 1353: 92 HR 128/84, 100%, nauseated - coolw ash clothes applied - needed to transfer to a better chair that would lay back 1400: HR 72, 120/80, 100%, 36.7 - Felt warm but cool, wanted warm blankets - said she feels like she is sinking into the chair. HR 73, 118/78, 100% feeling better. 1409: 70 HR, 115/76, 100%, orthostatics taken. 1411: 69 HR 118/77, 100%, sat up 1414: 79 HR 123/87 99% took O2 off - felt ok. 1419 67 HR 121/83 100% standing felt okay, not dizzy.
47 2021-01-12 flushing, feeling hot Metal taste immediately after injection. 8:20 felt hot and flushed. blood pressure 118/78 heart ra... Read more
Metal taste immediately after injection. 8:20 felt hot and flushed. blood pressure 118/78 heart rate 100. 8:32 b\p 130/80 Heart rate 100 discomfort in neck back and headache. Reported she had a headache with the first dose. 8:50 states she is better and ready to go home. b\p 128/88 heart rate 90 Advised to seek medical help if symptoms worsen.
47 2021-01-12 flushing Pfizer-BioNTech COVID-19 Vaccine 1/13/2021, patient got 2nd dose of vaccine and minutes later exper... Read more
Pfizer-BioNTech COVID-19 Vaccine 1/13/2021, patient got 2nd dose of vaccine and minutes later experienced flushing and redness in chest area and sent to ED for evaluation. Arrived to ED at 9:52 am and was given diphenhydramine 50 mg and famotidine 20 mg. Clonidine 0.3 mg given at 12:18 pm for high BP. At 11:20 am rash almost resolved, feeling better; discharged at 12:30pm
47 2021-01-12 flushing Systemic: Nausea-Medium, Systemic: flushing; symptoms lasted 1 day
47 2021-01-12 pain in extremity Chills, headache, arm pain, nausea, body aches and pain
47 2021-01-12 pain in extremity Shortly after injection, pain at site; continued pain in arm today. Some fatigue yesterday and tod... Read more
Shortly after injection, pain at site; continued pain in arm today. Some fatigue yesterday and today. Major headache today, not all day just part of day.
47 2021-01-12 tingling Light fluttery, tingles throughout bilateral arms down through hands-
47 2021-01-12 tingling approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down... Read more
approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down to my hands and right side of my chest. Lips felt swollen but not visible to the eye. My right lower extremity had the same feeling as describe what happened to my right arm. I went to the ED of the hospital where I worked. This my second dose and I had the same experience with the first dose but on my left side.
47 2021-01-12 tenderness Patient's report: "Started to notice swelling in my right arm pit on 1/12/2021 and tenderness in my ... Read more
Patient's report: "Started to notice swelling in my right arm pit on 1/12/2021 and tenderness in my neck also on 1/12/2021 I had the second shot on 1/11/2021 at 12pm"
47 2021-01-13 discomfort 12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and... Read more
12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and the chills. I was up the remainder of the night. By morning I had a bad headache and terrible body/muscle aches. I was unable to report to work that day. By midafternoon, the nausea and stomach pains subsided, all other symptoms remained along with then getting a 100.5 fever. I was taking Tylenol every 4 hours since 1am and keeping hydrated. By midnight I was exhausted and was finally able to sleep. I woke the following morning with a dull headache and just felt achy. I felt much better by that evening (now Monday). Tuesday morning I woke with discomfort to my left armpit and clavicle area. I then noticed swelling, the areas felt ?lumpy? and were very tender to touch. That lasted about 2 days.
47 2021-01-13 feeling hot Systemic: heart rate went up to 170bpm, felt hot, bp 160/80, came down to 109 bpm-Mild; symptoms las... Read more
Systemic: heart rate went up to 170bpm, felt hot, bp 160/80, came down to 109 bpm-Mild; symptoms lasted 1 day
47 2021-01-13 numbness Systemic: Chills-Severe, Systemic: Chills/numbness lead to hyperventilating, felt better after takin... Read more
Systemic: Chills-Severe, Systemic: Chills/numbness lead to hyperventilating, felt better after taking benadryl and is back to normal-Severe; symptoms lasted 0 days
47 2021-01-13 migraine Fever, chills, dizziness, headache. Fever on and off from 1/9/21 through 1/14/21. Fever, chills, mus... Read more
Fever, chills, dizziness, headache. Fever on and off from 1/9/21 through 1/14/21. Fever, chills, muscle ache 1/9/21 through 1/14/21. Severe headache/migraine from 1/11/21 to present (still have).
47 2021-01-13 pain in extremity a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued a... Read more
a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued at 99.7 and her symptoms were 10 fold; Left arm soreness; Increased dry cough; Nasal congestion; Chills; Headache; Unable to sleep- tossing and turning; This is a spontaneous report from a contactable nurse reporting for self. This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: Apr2021) on 04Jan2021 around 10:30 AM at 0.3 mL single by injection in the left arm for COVID-19 immunisation. Medical history and concomitant medications were none. Prior to getting the vaccine patient had her temperature taken on unspecified date, which was 97.4. She had the injection in her left arm on 04Jan2021 around 10:30 AM. After she felt perfectly fine that day. She felt nothing. Then around 8 PM her side effects started. That night her left arm got sore, she had increased dry cough (reported as feels like a bronchial spasm that an asthmatic would have), nasal congestion, chills, and a headache. She went to bed unable to sleep- tossing and turning. She woke up around 2 AM or so. The next morning, 05Jan2021, she felt somewhat okay. She went to work. She had a normal temperature that morning at work. Then around 10 AM, her arm was still sore, she was not feeling quite well, she started to feel chills again, and had a fever of 99.5, along with a headache still. They sent her home. The next day, 06Jan2021, her fever continued at 99.7 and her symptoms were 10 fold. Then her fever broke around 10 AM. On 05Jan2021, she took a shower from all the sweating with her fever, and she did not notice any rash. She took another shower this morning (07Jan2021) and she noticed a weird rash on her left shoulder area. It does not itch, it is just there. She took a picture of it so she could monitor it. It is blotchy. For left arm soreness, she can now move it without feeling it, but then you touch it, it is sore and tender. The event fever broke yesterday around 10 AM. This morning (07Jan2021) her temperature was 98.6. Chills would come and go with the fever off and on. Treatment for all events included over the counter medications. Lab data included COVID test was negative on 28Dec2020 and 04Jan2021. Outcome of left arm soreness, increased dry cough, nasal congestion was recovering, outcome of chills, headache, unable to sleep- tossing and turning was recovered on 06Jan2021, fever was recovered on 06Jan2021 10 AM, outcome of rash was not recovered, outcome of other event was unknown. Relatedness of product to all events was reported as related, the reporter considered all events as non-serious.
47 2021-01-13 pain in extremity intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of... Read more
intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of Benadryl. via IV in right arm. I went home and slept for 3 hours. Woke up Right hand swollen and painful, muscle aches, headache, itching
47 2021-01-14 inability to speak, slurring, throat numbness approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to t... Read more
approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to take deep breath. Severe difficulty swallowing. Difficulty getting words out, then slurring of words/poor pronouncing of words. Foggy head. Poor balance.
47 2021-01-14 facial pain I developed left forehead and scalp pain associated with a rash-shingles. I did seek care with my ... Read more
I developed left forehead and scalp pain associated with a rash-shingles. I did seek care with my PCP and was treated.
47 2021-01-14 feeling hot felt body rush, got hot rise from legs on up
47 2021-01-14 flushing Lightheaded; flushed; This is a spontaneous report from a contactable pharmacist. A 47-year-old fema... Read more
Lightheaded; flushed; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Dec2020 (Batch/lot number: EJ1685) at a single dose on left arm, and received the second dose, intramuscular on 08Jan2021 (Batch/lot number: EK9231) at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded and flushed on an unspecified date. Treatment not received for the adverse events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
47 2021-01-14 numbness 24 hours post injections, tongue numb, r.side of face, lips tingling, up to r.ear and r.cheek. No S... Read more
24 hours post injections, tongue numb, r.side of face, lips tingling, up to r.ear and r.cheek. No SOB, no swelling. 4 days later lips tingling. 7-9 days later random numbness and tingling of tongue, r. cheek, lips....comes and goes. No rescue medication used. No follow up pursued by patient.
47 2021-01-14 tenderness, pain in extremity The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I f... Read more
The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I felt tired and chilled, without fever. After the third day, symptoms subsided and I was back to normal activity. On the 7th day following the vaccine, I began having pain in the armpit of the left side. It was painful to have pressure on the area and to raise the arm overhead. It progressed on the the 8th day with increased pain and tenderness to touch. On the 9th day, I had severe pain with palpation and could feel a lump in the armpit. I have no redness, heat, or rash in the area. I went to my physician with concern because I have had a double mastectomy two years ago.
47 2021-01-15 numbness, tingling Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has s... Read more
Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has spread through shoulders and upper back; challenges in arms and legs?very little control, hard to even lift arm to eat, to type?like heavy weight pressing down on arms and shoulders, like filled with lead and extreme stiffness; still have floating feeling off and on; still have tingling in face, arms, and hands; dizziness; mental fog; headaches; heart palpitations; hands swelling--difficult to use. This has been ongoing for eleven days now. Other symptoms can be found in report made to Pfizer site: (1/12/2021 at 2:27 pm)
47 2021-01-15 tingling Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness contin... Read more
Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness continuted through out the day Increased Heart Rate had continued off and on, went to ER and have seen Cardiologist
47 2021-01-15 tingling Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anor... Read more
Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anorexia, intermittent paresthesias, SOB, Chest Discomfort for 14 days straight, slightly better today.
47 2021-01-16 feeling hot I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on m... Read more
I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on my back, swelling of my eyelids, and lips.
47 2021-01-16 pain in extremity Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscle... Read more
Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscles aches through mid back and chills Day 3 - Exhausted and achy, nauseous, chills, sweats Day 4- Adverse reactions gone.
47 2021-01-16 pain in extremity severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine d... Read more
severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine dose, extreme pain in right arm, leg, neck, and right side of the stomach started on day 2 - phone appointment with doctor , rash started on day 3 - urgent care visit, diagnosed with shingles after dermatology consult
47 2021-01-17 weakness, feeling cold, tremor I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my... Read more
I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour . My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision
47 2021-01-17 tingling Received covid vaccine number one on December 23. By December 25 she developed tingling in the tips ... Read more
Received covid vaccine number one on December 23. By December 25 she developed tingling in the tips of her toes and in her fingers. She found this concerning. She spoke to her rheumatologist as well. The rheumatologist recommended she go to the ED. She was recommended to see a neurologist. Neurologist is planning to test her for GBS.
47 2021-01-18 weakness Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever
47 2021-01-18 weakness fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, we... Read more
fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, weakness, bone pain, abdominal cramps, loose stool--that had mucous and blood in it. Also had a small amount of vaginal bleeding/spotting not associated with her period. Multiple days of these symptoms.
47 2021-01-18 involuntary muscle movements I was having involuntary muscle movement in my arms, neck and legs while trying to sleep last night.... Read more
I was having involuntary muscle movement in my arms, neck and legs while trying to sleep last night. I've been up for approximately 4 hours and have not had any symptoms once I was awake and moving around.
47 2021-01-18 pain in extremity, flushing Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mi... Read more
Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mid cheek and full face mild puffiness. Difficulty swallowing only for 5 min then sore throat since then. Nausea starting about 2 hours after. Left arm swelling and a lot of pain for a couple hours in the middle of the night and still very sore but better. Woke up with both eyes bloodshot. Feeling like my scalp was hot and tight for about a half hour but that went away.
47 2021-01-18 pain in extremity, pain in extremity Arm soreness, chills, sore throat, nausea, body aches, headache
47 2021-01-18 pain in extremity Body aches, sore throat, runny nose, and sore arm beginning 1/14/2021. Took OTC medication on 1/14/... Read more
Body aches, sore throat, runny nose, and sore arm beginning 1/14/2021. Took OTC medication on 1/14/2021 with improvement. Symptoms have since resolved.
47 2021-01-18 pain in extremity Recieved 1st dose of Covid Vaccine Lot #EH9899 on 12/22/20. Employee had tested positive for Covid ... Read more
Recieved 1st dose of Covid Vaccine Lot #EH9899 on 12/22/20. Employee had tested positive for Covid 7/5/20 and had recovered from severe cough. After recieving 1st dose of vaccine later that day, patient started having return of the cough. , then also had HA and leg pain. Received 2nd dose of Covid on 1/12/21 and immediately had severe stomach pain, then had diarrhea. Cough worsened the next day, developed sore throat, HA, runny nose, congestion, shortness of breath and would feel faint at times.
47 2021-01-19 weakness Fever of 103, severe chills, body aches, joint pain, weakness, cough, headache, sore throat
47 2021-01-19 weakness Woke up at 1am with fever of 103 and unable to get out of bed due to muscle weakness. Continued with... Read more
Woke up at 1am with fever of 103 and unable to get out of bed due to muscle weakness. Continued with fever and chills until 7pm. Had a throbbing headache from 2pm until midnight. Severe muscle weakness and bone pain. No appetite at all. Next day still weak and sore but fever gone and about 75% better.
47 2021-01-19 night sweats, weakness Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cra... Read more
Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cramping; Fatigue; Some sweating in the middle of the night; some pain behind her eyes; Shoulder area is sore; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK4176), via an unspecified route of administration on 09Jan2021 11:00 in left arm at single dose for COVID-19 immunization. Patient take medications for mood and sleep with were very low doses. But she didn't have any medical problem. She took 10 mg of fluoxetine hydrochloride (PROZAC), 150 mg of bupropion hydrochloride (WELLBUTRIN) and 10 mg of doxepin for sleep. Yesterday after the vaccination towards the end of the day (09Jan2021 approximately 11 o' clock am), she developed a stomach ache about 5 pm and it went on throughout the night and she normally didn't have issues with her stomach. Maybe it was because she was hungry because she went ice skating with her son where they wore mask in the afternoon yesterday and she was feeling perfectly fine. But when she came home, she noticed her stomach started hurting at 5 pm and she wondered maybe it is because she was hungry. And after she ate it was still bothering her and then it got progressively worst in the middle of the night where it would wake her up periodically. But she was so fatigue that she was able to sleep still. But she noticed in the middle of the night that her stomach would wake her up because it was aching and cramping in the middle of the night. And then she also had some sweating in the middle of the night as well as some pain behind her eyes. And today (10Jan2021) she had some fatigue which she noticed was not usual, she had mild headache which she saw was a common side effect. And then in the morning (10Jan2021) some fatigue and weakness like when she walked to the bathroom it was hard for her to walk. And when she went to use the bathroom she had some loose stools which was not common for her unless at all she was sick or have eaten something that makes her stomach really sick which was very unusual for her. Her stomach was still hurting her, if she walked it will start getting cramped so she was sitting down. The only thing she toon this morning was 2 acetaminophen medicine tablets because she was having pain behind her eyes when she woke up. She was just going to say she had influenza type A and type B on several occasions. And these symptoms are similar to when she had type B influenza, which was not as difficult as type A. So this is, they seemed to be like a mild version of type B influenza which she had terrible stomach issues, diarrhea and fatigue and pain behind the eyes from type B influenza. She had not any sickness because she work from home and she had limited field contact. So, she hadn't had illness from past year now. Because she worked from home. She provided mental health counselling remotely. So, she didn't think it could be attributed from anything else. The left on arm which was up toward like shoulder area and it was sore but it was tolerable in Jan2021. Outcome of stomach ache/stomach cramping was not recovered, and outcome of other events were unknown.
47 2021-01-19 pain in extremity Sore arm- could not raise arm above shoulder, 106 fever, muscle/joint/body aches for 3 days, seen in... Read more
Sore arm- could not raise arm above shoulder, 106 fever, muscle/joint/body aches for 3 days, seen in ER after 24 hours of symptoms. Fatigue for 1 week post vaccination.
47 2021-01-19 tenderness Pfizer-BioNTech COVID-19 Vaccine EUA On the evening of 1/19/21 I noticed my arm in the area of my va... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA On the evening of 1/19/21 I noticed my arm in the area of my vaccine was sore to the touch. As the evening progressed, my shoulder joint became sore and got worse throughout the evening and became very sore to lift my arm. This morning it is still very sore, and now my neck feels ?stiff? and also it?s tender to move.
47 2021-01-19 tremor Patient had her vaccination and went back to work for about 15 min. When she was at work, she felt h... Read more
Patient had her vaccination and went back to work for about 15 min. When she was at work, she felt her legs shaking and tingling on her top lip. She came back to the vaccine clinic and asked to be monitored. Vital signs taken 138/90, HR 109 POX 100 RA. Continued to have tingling upper lip and brought to ED for further observation. Warm hand off to ED RN
47 2021-01-20 discomfort First dose without incident. 18Jan2021 6:40am 2nd dose - 12hr later felt blah, 24hrs later extremely... Read more
First dose without incident. 18Jan2021 6:40am 2nd dose - 12hr later felt blah, 24hrs later extremely dizzy with moderate headache and body aches. then at 4am 20Jan2021 (right around 48hrs), I had erythema with a blister on left lateral side around rib region 8-10 with itching and burning. This improved to no erythema and this morning (21Jan2021) only 3 blisters with mild discomfort.
47 2021-01-20 flushing, feeling hot 10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and f... Read more
10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and flushed and experienced mild difficulty breathing. A rapid response was called, patient noted to have a swollen and red face and neck. 0.3mg IM Epinephrin given. HR 108, SpO2 98% on room air. Patient taken to the emergency department for follow-up. In the ED patient reported feeling anxious, nauseous, and having a dry mouth. Notes that she had never had a reaction to a vaccine before. Diagnosed with an allergic reaction to the COVID-19 vaccine. Benadryl, pepcid, and Solumedrol given.
47 2021-01-20 numbness, pain in extremity Pain and numbness in arm of injection; Pain and numbness in arm of injection; This is a spontaneous ... Read more
Pain and numbness in arm of injection; Pain and numbness in arm of injection; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1282 and expiration date not provided), via an unspecified route of administration in the left arm on 11Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included diabetes mellitus. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications included metformin, lisinopril, and aspirin (ACETYLSALICYLIC ACID). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 11Jan2021 14:00, the patient experienced pain and numbness in arm of injection. Treatment was not provided in response to the events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
47 2021-01-20 pain in extremity, migraine she had left arm pain as well; she is very sweaty now; had a migraine yesterday; she had achy joints... Read more
she had left arm pain as well; she is very sweaty now; had a migraine yesterday; she had achy joints all over yesterday; had achy joints all over yesterday, saying her neck hurt; felt sick with a runny nose; felt sick with a runny nose; the gland in her armpit (clarified as left armpit) area is swollen and very painful; the gland in her armpit (clarified as left armpit) area is swollen and very painful; hard time sleeping.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231, expiration date 30Apr2021), via an unspecified route of administration on 09Jan2021 11:50 at single dose (left arm) for COVID-19 immunization. Medical history included penicillin rash. There were no concomitant medications. The patient previously took diflucan 15 years ago and experienced extreme allergic reaction to diflucan; and amoxicillin and experienced rash. She stated she had a rash in the past to Amoxicillin and Penicillin. She received the COVID-19 vaccine on Saturday (09Jan2021), and the gland in her armpit (clarified as left armpit) area was swollen and very painful. She said she took Tylenol, and the Tylenol cut the pain. She stated she still has a little pain today. Her left armpit started feeling uncomfortable on Saturday night, and she had a hard time sleeping. She said when she woke up on Sunday morning, 10Jan2021, her left armpit area was extremely painful, clarifying she had left arm pain as well. She said the pain in her left arm has lessened today, but her left armpit area was still painful. Clarified she took a repeated 3 Tylenol 200 mg (600mg) dose over the past couple days for her left armpit pain. She took her first dose of 3 Tylenol 200mg tablets (600mg dose) at noon on Saturday, 09Jan2021, and another 3 Tylenol 200mg (600mg dose) at 5:00PM on Saturday evening and went to sleep. She said she woke up after her nap on Saturday evening, and was sweaty and had left armpit pain. She said she took another 3 Tylenol 200mg tablets (600mg dose) on Sunday, 10Jan2021, at 5:00PM. She said she took her last dose of 3 Tylenol 200mg tablets (600mg dose) this morning, 11Jan2021, at 7:00AM. On Saturday night, 09Jan2021, it was only her left armpit that was sore, but by Sunday, 10Jan2021 morning, her whole left arm was in pain and the gland in her left armpit was swollen. On 10Jan2021, the patient was very sweaty, and had a migraine. Clarified she felt sweaty now, like she just woke up from a fever. She said she was not overdressed, but maybe she was in a hot environment. She said she had no fever when she checked her temperature. She also had achy joints all over and her neck hurt on 10Jan2021. Patient reported that she had a PPD skin test administered 2 months ago and had no reaction to the PPD skin test. She felt sick with a runny nose on 10Jan2021, but she felt fine today, 11Jan2021. She said that after she received the COVID-19 vaccine, it was less than 24 hours when everything started happening. The patient had no history of all previous immunization with the Pfizer vaccine and no vaccines administered on the same date of the vaccine. The patient had no prior vaccinations within 4 weeks. Outcome of event hard time sleeping was unknown; she had left arm pain as well, had achy joints all over yesterday, saying her neck hurt, felt sick with a runny nose, was recovering; had a migraine yesterday was recovered on an unspecified date; and outcome of the rest of events was not recovered.
47 2021-01-20 pain in extremity For my first dose I had no significant side effects, LOT: EJ1686. ) After receiving my second dose... Read more
For my first dose I had no significant side effects, LOT: EJ1686. ) After receiving my second dose injection, I felt lethargic, had cold, chills with soreness to left arm. I had significant abdominal pain, my abdomen was distended and swollen. Two weeks prior to the 1st dose injection I had had abdominal surgery. I experienced peristalsis with pain with possible obstruction. I have an ileostomy., and with the vaccine I experienced (high pitched noise coming out of my stomach which caused me to vomit and fee weakness to my abdomen. i took Octeotide injection for my abdominal pain. I also took Ibuprofen for pain. My doctors said that my abdominal pain was most likely related to the injection. I went into surgery 12-14-2020 for removal of an abdominal mesh due to the ileostomy and infection. I currently can not lift no more than 10 pounds. At this time, I feel better and will be returning to work.
47 2021-01-20 tingling, weakness, pain in extremity weakness, dizziness, tingling to body, palpitations, skipping heart beat, pain to left leg, describe... Read more
weakness, dizziness, tingling to body, palpitations, skipping heart beat, pain to left leg, described her left leg veins appeared transiently engorged soon after 1st dose of pfizer covid vaccine
47 2021-01-20 tingling, numbness Numbness hands arms face and mouth and lightheaded 30 minutes post vaccine. 12 hours after vaccine 1... Read more
Numbness hands arms face and mouth and lightheaded 30 minutes post vaccine. 12 hours after vaccine 102 fever, severe body aches, chills, stomach ache, and diarrhea. Took acetaminophen 1000 mg at 2 am. Stomach issues subsided 7 am, 20 hours after vaccine. Fever over 101, chills, body ache, and headache remained for 3 days. All symptoms have subsided except right side of face still tingling and numb.
47 2021-01-20 tingling, pain in extremity, numbness I received the 1st dose of vaccine on 12/16/20 and on that date through 12/18/20, I had severe arm s... Read more
I received the 1st dose of vaccine on 12/16/20 and on that date through 12/18/20, I had severe arm soreness and body aches. On 12/20/20, I had a sore throat, headache, body aches, and nasal congestion that continued through 12/24/20. On 12/25/20, I had extreme body aches, fatigue, left arm and leg numbness and tingling, SHOB, temp of 100.6, and back pain. On 12/27/20, I went to the ER for my symptoms and to be tested for COVID-19, to which I tested positive. They also tested me for strep and flu, both were negative. I also developed intermittent and random tachycardia (HR 120-150's), palpitations, chest tightness and chest pain. I am a RN and monitored my O2 Sats and HR frequently. My symptoms finally resolved enough for me to return to work on 1/11/21.
47 2021-01-20 tingling Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. Has tingling in hand, head ache, spin... Read more
Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. Has tingling in hand, head ache, spinning, body aches. Has been a week since covid vaccination.
47 2021-01-21 migraine Migraine- worse I ever had, with shooting pain on the left side of my neck up to base of skull on th... Read more
Migraine- worse I ever had, with shooting pain on the left side of my neck up to base of skull on the same sideI received the shot in my shoulder
47 2021-01-21 migraine Migraine- the worse I?ve ever experienced. Shooting pain up the left side of neck to base of skull o... Read more
Migraine- the worse I?ve ever experienced. Shooting pain up the left side of neck to base of skull on the same side where I got the shot in my left shoulder
47 2021-01-21 pain in extremity Extreme Fatigue, lethargy, arm soreness, headache, fogginess.
47 2021-01-24 pain in extremity Had pain underneath arm; Then whole lymph nodes were swollen up until her armpit; This is a spontane... Read more
Had pain underneath arm; Then whole lymph nodes were swollen up until her armpit; This is a spontaneous report from a contactable Other-HCP (patient). A 47-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at SINGLE DOSE for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced side effects after she got her 1st dose last 24Dec2020. On 26Dec2020, she had pain underneath arm and then whole lymph nodes were swollen up until her armpit 2 days after receiving the vaccine. Her 2nd dose is scheduled this Thursday and wants to know if she should get it. The outcome of the events was unknown. Information about lot/batch number has been requested.
47 2021-01-24 pain in extremity Fever Body Aches left underarm pain, and swollen
47 2021-01-25 flushing, flushing 47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd ... Read more
47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd dose of COVID 19 vaccine. Patient denied experiencing any SOB, difficulties breathing and difficulties swallowing. She described abdominal pain as sharp with sudden onset following vaccine. Patient does have a history of abdominal pain and is currently followed by GI. At that time, RN contacted provider for consult. Patient was evaluated by provider and 25 Mg PO Diphenhydramine ordered and given at 1533 Log: 502213 EXP: 3/31/21. Patient V/S at that time were: BP 144/90, HR 98, 02 99, Temp 98.1. Patient was observed by RN for an additional 15 minutes. V/S at 1545 - BP 129/79, HR 83, O2 99, temp 98.1. Pt facial flushing had visibly improved and her husband was contacted to pick up. Per provider, patient was released to self care with ER precautions provided.
47 2021-01-25 flushing 47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd ... Read more
47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd dose of COVID 19 vaccine. Patient denied experiencing any SOB, difficulties breathing and difficulties swallowing. She described abdominal pain as sharp with sudden onset following vaccine. Pt does have a history of abdominal pain and is currently followed by GI. At that time, RN contacted provider for consult. Patient was evaluated by provider and 25 Mg PO Diphenhydramine ordered and given at 1533 Log: 502213 EXP: 3/31/21. Pt V/S at that time were: BP 144/90, HR 98, 02 99, Temp 98.1. Patient was observed by RN for an additional 15 minutes. V/S at 1545 - BP 129/79, HR 83, O2 99, temp 98.1. Patient facial flushing had visibly improved and her husband was contacted to pick up. Per provider, patient was released to self care with ER instructions if symptoms return/worsen provided.
47 2021-01-25 migraine Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pa... Read more
Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pain with swelling. 72 hours into time left side of body was swollen to point that clothing and jewelry do not fit. Left under arm and Breast are extra swollen *approximately triple size of right side. Migraine at 30 hours. Stomach pain in right side at 28 hours, also nausea and diarrhea.
47 2021-01-25 pain in extremity This is a spontaneous report from a contactable nurse (Patient). A 47-year-old female patient receiv... Read more
This is a spontaneous report from a contactable nurse (Patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on30Dec2020 to 30Dec2020 at single dose for COVID-19 immunization. She had a history of pancreatitis and was hospitalized with elevated lipase levels one and a half weeks prior to getting her first dose in Dec2020. When she received the first dose she had recovered and her lipase levels were normal in Dec2020. Her gastroenterologist has scheduled her for a colonoscopy and upper endoscopy but would like for her second dose to be spaced out a week from her first dose. She is asking if there is any data to support efficacy of the second dose of the vaccine between days 28-32. The doctor stated she is okay as long as she gets the second dose of the vaccine within 5 months from the first dose. She had pancreatitis and needs to have a procedure for it. She was scheduled for second dose on 18Jan2021. She has an endoscopy and colonoscopy scheduled for 21Jan2021 and her GI doctor advised to postpone her second dose which she was told she should get 17- 21 days after her first dose since it would coincide with her procedure. She does not have a problem with the vaccine. She had a sore arm on an unknown date and was totally fine. The outcome of the event sore arm was recovered on an unknown date. Information on the lot/batch number has been requested.
47 2021-01-25 pain in extremity Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was ab... Read more
Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was about 14 hours after injection
47 2021-01-25 tremor, cold sweat Tachycardia, sweating, uncontrollable shaking, clamy hands and vomitimg
47 2021-01-26 weakness, migraine Migraine headache unresponsive to migraine medication, lasting 24 hours, mild fever, dehydration. We... Read more
Migraine headache unresponsive to migraine medication, lasting 24 hours, mild fever, dehydration. Weak/tired for the following 24 hours.
47 2021-01-26 flushing Flushing, heart racing, itching in fingers
47 2021-01-27 burning sensation, tingling Tingling/ burning sensation first started in toes on bilateral feet. On day 17, severe tingling/burn... Read more
Tingling/ burning sensation first started in toes on bilateral feet. On day 17, severe tingling/burning started on left hand.
47 2021-01-27 flushing facial flushing, mild generalized puritis
47 2021-01-27 migraine Migraine, muscle aches, fever and chills. Treated with Tylenol. All symptoms resolved within 36-40 h... Read more
Migraine, muscle aches, fever and chills. Treated with Tylenol. All symptoms resolved within 36-40 hours.
47 2021-01-27 cold extremities, pain in extremity deltoid was still sore, but felt cold/entire arm and hand feels cold, worse when the area is rubbed;... Read more
deltoid was still sore, but felt cold/entire arm and hand feels cold, worse when the area is rubbed; Deltoid still sore/soreness in the forearm; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ES1686), via an unspecified route of administration in the left arm on 04Jan2021 14:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D), probiotics, and elderberry [sambucus nigra]. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's deltoid was still sore, but felt cold on day 3 (07Jan2021). By day 7 (11Jan2021), the entire arm and hand feels cold, worse when the area is rubbed. By day 8 (12Jan2021), the patient had soreness in the forearm and still unchanged at day 11. No weakness was noted. The patient had good pulses on Jan2021 and no visible change to the skin. No treatment was received for the adverse events. Outcome of the events was not recovered.
47 2021-01-27 tenderness left underarm was hurting; There was a pear size lump that is very tender there. It feels fluid fill... Read more
left underarm was hurting; There was a pear size lump that is very tender there. It feels fluid filled to her; There was a pear size lump that is very tender there. It feels fluid filled to her; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3302,via an unspecified route of administration in the left arm, on 12Jan2021 10:00 at SINGLE DOSE for COVID-19 immunization. Medical history sleep apnea, GERD, TMJ and depression. Historical vaccine included first dose of BNT162B2 on 22Dec2020 for COVID-19 immunization. Concomitant medication included cefixime (FLEXERIL), fluoxetine hydrochloride (PROZAC), omeprazole (PRILOSEC) and trazodone. on 13Jan2021 12:00, 24 hrs post vaccination, patient noticed that her left underarm was hurting, and she touched it. There was a pear size lump that is very tender there. It feels fluid filled to her. Therapeutic measures were taken as a result of events included an unspecified treatment and will be receiving an ultrasound. Outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
47 2021-01-27 tremor Severe chills lasting 24 hours, Severe shaking x 2 hours, Headache x 5 days, Fatigue x 3 ays. Trea... Read more
Severe chills lasting 24 hours, Severe shaking x 2 hours, Headache x 5 days, Fatigue x 3 ays. Treated with Tylenol (for up to 5 days post injetion), Ibuprofen.
47 2021-01-28 weakness she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so ... Read more
she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; tested positive for COVID; tested positive for COVID; not feeling very well; feeling dizzy and weak; feeling dizzy and weak; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included Diabetes which was diagnosed in Apr2020. There were no concomitant medications. The patient received the first dose of the vaccine on 22Dec2020. She tested positive for COVID19 on 08Jan2021. The second dose of vaccine on 12Jan2021 was deferred as the patient was not feeling well on an unspecified date in Jan2021. She asked for guidance/information about receiving the second dose after testing positive. She stated that she was still feeling dizzy and weak on an unspecified date in Jan2021. She said that she heard the people were not feeling too well after the second dose and she will get it as long as it will not kill her. She asked what will happen if she does not take the second dose and will she need to get the series again. She wanted to know if she can take the second dose of vaccine. She clarified that she was supposed to get her second dose on 12Jan2021 but she was not feeling very well so now they were telling her to go on the weekend. She does not feel fine. She asked if it was safe for her to take the second dose or should she wait. She wanted to know if the effect of the first dose is null since she has now delayed it so long. She is the supervisor of ultrasound department. She started having COVID symptoms of 04Jan2021, she was tested on 05Jan2021 and got a positive result on 08Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID19 based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
47 2021-01-28 bell's palsy Bell Palsy
47 2021-01-28 feeling cold, feeling hot ears have been burning; she checked her temperature and it is lower than normal, her temperature is ... Read more
ears have been burning; she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit; feels like her ears are hot; low iron; it feels like someone is pouring ice on her back/ she finds herself so cold; chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231, expiration date not reported) intramuscular on 30Dec2020 at, single for COVID. The patient had no medical history. There were no concomitant medications. The patient said that calling she was having a side effect that is not on the list of side effect. She does not know if it was from the chills but her ears have been burning ever since had the shot. She feels like her ears were hot. Can the vaccine cause this to happen? She clarified she was not having chills, it doesn't feel like chills, she said on the second day after the vaccine she had chills but right now it felt like someone was pouring ice on her back and she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit. Her ears have been burning. Her first dose was given 30Dec2020. That was another reason she was calling should she get the second dose if she was feeling this way. She said her ears began burning sometime last week and it has not stopped. Sometimes it will go away and come back but she find herself so cold she has to get under the covers and it takes forever to warm up. Today she put a hat and a scarf around her ears to warm up in doors. She has low iron. She doesn't know with her having low iron all her life and she has never experienced this before. Outcome of the event ears have been burning was not recovered while unknown for the other events.
47 2021-01-28 feeling hot Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision;... Read more
Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; has pain in her rib cage close to the arm pit occurring mostly at night; hot at night; The initial was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 13Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). This 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left upper arm on 11Jan2021 at 11:00 at single dose for COVID-19 immunisation. Relevant medical history included knee pain. There were no concomitant medications. On 11Jan2021, the patient experienced "blurry vision; darkening in the eyes; I felt like something in my eye like heaviness" and in Jan2021 she experienced pain in her rib cage close to the arm pit occurring mostly at night and hot at night. The patient stated "I wanted to tell you that after the shot I was for 15 minutes sitting on a chair and I didn't feel anything and then I left and went for a walk and when I was walking by the gift shop at hospital, I noticed I just got blurry vision like when I looked at the stock, it kind of looked darkening in the eyes and blurry". She stated also "You know exact time I wouldn't tell but for the day like it happened first time near the store and later in the day when I was working, I felt like something in my eye you know like heaviness I don't know if that's blurriness but then runs away so like later yesterday I am fine and today I am okay". The patient also specified that blurry vision started 20 minutes after the vaccine and lasted 10-20 seconds and later during the day when she was reading. The patient also reported she was hot at night and has pain in her rib cage close to the arm pit occurring mostly at night. The patient did not receive corrective treatments; she just blinked and then she went and sit down, it never came back again. At the time of the report, the outcome of the events was unknown. The information on the lot/batch number has been requested.
47 2021-01-28 nerve pain First dose given 12/24/2020 injection site pain developed 12 hours after vaccine given and resolved ... Read more
First dose given 12/24/2020 injection site pain developed 12 hours after vaccine given and resolved by 24 hours post vaccination. Trunk rash developed 48 hours after vaccine and resolved within hours. Twelve hours after second dose on 1/14/2021, developed chills, aches, burning neuropathic pain all over, temperature of 101 degrees F. After 5 hours took 600 mg ibuprofen with relief and required another dose at noon the day after vaccination. Symptoms resolved within 24 hours. Developed pruritic trunk rash that lessened within hours but took > 2 weeks to resolve.
47 2021-01-28 pain in extremity Left arm pain and stiff; left clavicular lymph node swollen and painful; temp max 101; malaise, decr... Read more
Left arm pain and stiff; left clavicular lymph node swollen and painful; temp max 101; malaise, decrease appetite; loose bowel movement.
47 2021-01-28 tingling Patient is a 47 y.o. female that presents from employee health after receiving the COVID-19 vaccinat... Read more
Patient is a 47 y.o. female that presents from employee health after receiving the COVID-19 vaccination in her left arm. Within the 15-minute observation. She started developing a dry cough. She subsequently felt shaky, short of breath and felt a tingling in her throat. She states it feels funny when she swallows. She has noted tingling in her fingertips with associated discoloration. She has not noted any redness or swelling at the injection site. She has not developed a rash on her skin. She does have a history of COPD and uses inhalers and nebulizers. She has not tried an inhaler for the cough. She has had multiple medication allergies in the past including reactions to the Pneumovax and MMR. She denies chest pain. She has no abdominal pain. No nausea or vomiting. No leg pain. The patient presents to the emergency department after developing a cough, throat discomfort, shortness of breath and paresthesias following COVID-19 vaccination at 4 PM. She has no evidence of swelling of the lips, tongue or oropharynx on exam. She has no stridor or wheezing on exam. Her pulse oximetry readings are in the high 90s on room air. She received Benadryl, prednisone and a nebulizers treatment. She was observed in the emergency department for 2 hours and had improvement in symptoms. She was discharged in stable condition.
47 2021-01-28 tremor Woke up at 07:20 which chest tightness/pain and uncontrollable shaking. Temperature was 102 with h... Read more
Woke up at 07:20 which chest tightness/pain and uncontrollable shaking. Temperature was 102 with hospital grade temporal thermometer. Pulse rate of 140 and POX of 96. At 07:23 took 650mg Tylenol and 50mg oral diphenhydramine with 16 oz water. Chest tightness subsided around 10 minute mark and shaking stopped after one hour. Sleep from 10:00-16:00. Woke up with a headache and mental confusion.
47 2021-01-29 numbness, muscle spasms Woke with severe pain in right cervical spine muscles, right upper shoulder. Sharp burning radiatin... Read more
Woke with severe pain in right cervical spine muscles, right upper shoulder. Sharp burning radiating pain progression to right deltoid. Treatment, tried Aleve, Tylenol, massage without relief. Emergency room visit 1/27 8am due to worsening Symptoms. Dx of muscle spasms, prescribed Valium a 8 hours, lidocaine patch and Tylenol, heat. No relief to of pain. TeleHeath with pcp on 1/28, who again dx muscle spasm. Changes script to flexeril. No relief in pain and now new onset of numbness right . uncertain if this is related to covid but occurred less than 24 hours after vaccine and have never experienced this issue before and no other mitigating cause known
47 2021-01-31 burning sensation, tingling my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across ... Read more
my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across my chest; red splotchy rash; right side of my head was tingling; I was mildly tachycardic; This is a spontaneous report from a contactable other Health Professional (patient). A 47-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via an unspecified route of administration on 06Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included allergies to adhesive and nickel. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. There were no concomitant medications. It was reported that the day after vaccination, patient's right arm started to feel like it was on fire. This feeling quickly spread up neck and across chest and this area had a red splotchy rash. The right side of head was tingling. Patient took 50 mg diphenhydramine hydrochloride (BENADRYL) and headed to ER (Emergency Room) where patient received Dexamethasone. Patient was mildly tachycardic. Above events started on 07Jan2021 at 12:30. Outcome of the events was resolved.; Sender's Comments: The events are considered related to the suspect product based on the strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
47 2021-01-31 facial paralysis Individual developed a severe headache followed by a bloody nose post-vaccination with second dose. ... Read more
Individual developed a severe headache followed by a bloody nose post-vaccination with second dose. Individual reports continuing intermittent headaches followed by a bloody nose. She is to follow up with an ENT specialist. Patient also experiencing eye droop of right-side along with facial swelling of that side.
47 2021-01-31 flushing, night sweats Onset of headache during wait time. 2130 chills, feverish, headache, rash. 0230 rash, itchy throat, ... Read more
Onset of headache during wait time. 2130 chills, feverish, headache, rash. 0230 rash, itchy throat, flush, feverish, chills 1/23/21 headache, irritated throat, chills, feverish, rash, night sweats, swelling hands and feet, fatigue 1/24/21 itchy throat, rash, headache, chills, feverish, flush, swelling hands and feet 1/25/21 rash, irritated throat, headache, chills, feverish 1/26/21 mild rash, headache, chills, feverish 1/27/21 chills, feverish, mild rash 1/28/21 itchy throat, flushed, itchy, rash on entire body, feverish 1/29/21 mild rash, chills. 1/30/21 flushed and itchy, itchy throat, chills, feverish
47 2021-01-31 pain in extremity Chest pain. Upper back pain, jaw pain, pain in opposite arm
47 2021-01-31 tremor Days 1-3: Fatigue Day 4 (2/1/21): Fever of 100.5, shakes, and rash on left forearm
47 2021-02-01 weakness, tremor discomfort in my sternum; trouble breathing; chest congestion; increased weakness; shakiness in my l... Read more
discomfort in my sternum; trouble breathing; chest congestion; increased weakness; shakiness in my legs; Within 10mins I was feeling dizzy; increase palpitation; I told the nurse she checked my blood pressure. It was 157/87; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on the right arm on 15Jan2021 15:45 at a single dose for an COVID-19 immunization at a hospital. Medical history included GERD. There were no concomitant medications. On 15Jan2021 at 15:45 (reported as within 10 mins), the patient felt dizzy and increase palpitation. The patient told the nurse and she checked her blood pressure, it was 157/87. After 15 mins of vaccine infusion (16:00), she came back home and increased weakness with shakiness in legs noted. After 2 hrs. (18:00) all symptoms were gone. The next morning (16Jan2021), the patient had discomfort in her sternum. By late afternoon, she had trouble breathing with chest congestion. The patient took 3 puffs of inhaler so she can breathe. The patient mentioned that her inhaler is expired, it was given to her 3 years ago. She didn't want to use it but used it anyway so she can sleep. The events dizzy, palpitation, blood pressure high, weakness, shakiness, and discomfort in sternum were not treated. The outcome of the events weakness and shakiness was recovered on 15Jan2021 at 18:00 while the other events were unknown. Information about lot/batch number has been requested.
47 2021-02-01 feeling hot Felt warm and pain in upper back, 5 minutes after receiving vaccine. No numbness or tingling. BP - 1... Read more
Felt warm and pain in upper back, 5 minutes after receiving vaccine. No numbness or tingling. BP - 140/90, pulse 62, O2 sat 100%. Patient rested and felt better. Resolved, went home.
47 2021-02-01 flushing, feeling hot Employee reported that she had "flushing and felt very warm" for about 1 hour post Covid vaccination... Read more
Employee reported that she had "flushing and felt very warm" for about 1 hour post Covid vaccination at 2pm on 12/17/20. This dissipated after 1 hour. Employee then reports she "felt constipated and took some Dulcolax," and ate some food on the way home. At 1 am on 12/18, employee awoke with sore throat and began to experience intractable nausea, vomiting and diarrhea. At 5 am on 12/18, employee came to emergency department for treatment. She was given Zofran, dicyclomine and Tylenol # 3 and then discharged to home. Employee reports that nausea, vomiting, and diarrhea (with blood present), continued for several days and she was unable to work. On 12/22/20, employee still feeling ill, unable to eat with severe n/v/d. was given new prescription for Zofran as she reports she had used all of prior prescription from ER (was taking every 6-8 hrs). Employee began feeling better on 12/23/20 and returned to work. She reports she is not sure if reaction was from vaccine or not.
47 2021-02-01 numbness Received shot at approximately 2pm and was in observation chairs. Around 205pm I took a dose of tyl... Read more
Received shot at approximately 2pm and was in observation chairs. Around 205pm I took a dose of tylenol to attempt to prevent fever. I immediately noticed that the medication felt stuck in my esophagus and it was hard to swallow them down. Being a nurse I began to monitor more closely my breathing. I was able to take air into my lungs easily. Next I noticed that my nose became very stuffy and was difficulty to breath through but my airway continued to seem ok and I was breathing without difficulty through my nose. By about 210pm I had noticed that my face felt strange. As another few minutes progress my entire face felt numb like when your dental lidocaine is wearing off. It was a very disturbing feeling. I never had difficulty breathing but the throat and nasal swelling lasted about 1 1/2 hours. The facial numbness lasted at least 4 hours and my nose and tongue still feel a little strange even at this moment. I stayed in the observation area for about 35 minutes just to make sure I was not going to lose my airway before leaving. I am a nurse and I didn't want to get sent to the ER for hours just to be given benadryl since my airway was ok so I didn't report it at the time of incident. I had preloaded with zyrtec, pepcid and ibuprofen the morning prior to injection to try and avoid reaction or side effects that others were reporting. I think if I had not had antihistamine in my system I would have had anaphylaxis for sure. I went straight home and took more antihistamine. Contacted my doctor so she knew of the symptoms. She told me to continue the antihistamines for a few days and to go to the ER if severe issue happened. This was a VERY VERY scary incident. For a little history: after my first vaccine I noticed itching on my chest but couldn't see any rash. About day 3-4 a rash appeared. I was unsure if this was vaccine related since it took 3 days to appear. It was cleared after a few days of steroid cream.
47 2021-02-01 pain in extremity FEVER 100.4, BODY ACHES, HEADACHE, LEFT ARM PAIN - INITIALLY AT INJECTION SITE LATER ON FIRST DAY, A... Read more
FEVER 100.4, BODY ACHES, HEADACHE, LEFT ARM PAIN - INITIALLY AT INJECTION SITE LATER ON FIRST DAY, AND THEN ON 1/3/2021 NOTICED RED SPOT JUST BELOW INJECTION SITE THAT WAS TENDER AND WARM TO TOUCH, ROUGHLY 3X3 IN SIZE. ALSO FELT PAIN IN ARMPIT, TENDER TO TOUCH, BUT NO REDNESS. SINCE 1/30/2021 TOOK TYLENOL 5OOMG 1 - 2 TABS EVERY 6-8 HOURS AS NEEDED. RELIEVED MOST OF PAIN FEVER AND BODY ACHES SUBSIDED BY DAY 2 WHICH WAS 2/1/2021. HEADACHE AND ARM AND ARMPIT PAIN PERSIST
47 2021-02-01 tingling, numbness Patient reports intermittent numbness and tingling to bilateral thumbs, index and middle fingers and... Read more
Patient reports intermittent numbness and tingling to bilateral thumbs, index and middle fingers and palms. Patient states symptoms started the same day as receiving her second dose, later in the day. Patient unsure if she will seek further evaluation.
47 2021-02-01 tingling throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from... Read more
throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 1283), intramuscular in the left arm on 08Jan2021 at 17:00 (at the age of 47-years-old) as a single dose for Covid-19 immunization. Medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications included minocycline (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 08Jan2021 at 17:00, the patient experienced tingling immediately in left arm following injection, rapid heartbeat and throat closing. The patient was treated for the throat tightness, paraesthesia and heart rate increased which included diphenhydramine (BENADRYL), oral steroids, EKG and blood pressure monitoring. The events did initiate an emergency room visit. The clinical outcome of the events throat tightness, paraesthesia and heart rate increased was recovered with sequel. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "throat closing" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-02-03 weakness, face paralysis, numbness, throat numbness Immediately upon having the injection administered, my heart rate sped up. I sat down within the wai... Read more
Immediately upon having the injection administered, my heart rate sped up. I sat down within the waiting area for monitoring thinking that if I sat down for a bit, that it would maybe pass . Within about 7 minutes of that, I began to feel the back, left side of my throat go numb. I began to get very dizzy after that and I alerted one the pharmacy Nurses, that was on duty. She asked for me to open My mouth so that she could see if my throat was swelling & said that she didn?t see anything and I was told by her that it may just be anxiety that I was experiencing and she asked me to take a few sips of water and to try and relax a bit. She resumed helping others, while I continued to sit there. It was then when I experienced a heavy onset of chest tightness and the inability to breathe. The left side of my face and jaw went numb & that?s when I really knew something was wrong. I was taken outside for some fresh air and realize that I was so nauseous, more dizzy, very weak upon standing and I told the same nurse and another young lady that was assisting me that I felt like I was going to pass out and to please call EMS for me . At that time, I lost temporary feeling in all 4 limbs and I began to experience heart palpitations . I was having some trouble swallowing and I was laid down and. My blood pressure was taken. Blood Pressure was 235/130 and it was taken several times until emts arrived. It was then 200/120 and 180/112 by the time help arrived. Overall I experienced burning sensation in chest and abdomen, facial weakness and numbness left side fever loose stools weakness, shortness of brEath and chest tightness blurred vision felt like I?m out of touch with reality Malaise restless and the loss in feeling in my Limbs are slowly returning body And muscle and joint aches and pains and wheezing bouts
47 2021-02-03 weakness, tingling, numbness Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with ... Read more
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
47 2021-02-03 bell's palsy Acute development of Symptomatic Facial Bell's Palsy
47 2021-02-03 facial pain, tingling facial pain, redness, pins and needles like fiberglass been run across face Narrative:
47 2021-02-03 feeling of body temperature change NauseaVomiting "Hot and cold, afebrile" Narrative:
47 2021-02-03 numbness, weakness severe body pain, right leg numbness ,weakness and tired, diarrhea.
47 2021-02-03 pain in extremity Nausea, body aches, chills, swollen glands, sore arm.
47 2021-02-03 tingling, numbness, feeling cold Employee began complaining about a "cold feeling" in her rt arm followed by numbness and "pins and ... Read more
Employee began complaining about a "cold feeling" in her rt arm followed by numbness and "pins and needles" like sensation. She also complained that her rt arm was feeling swollen and red. Mild redness noted upon assessment but no obvious swelling visually. Observed employee for 30 minutes after vaccine and symptoms persisted. Employee has a history of severe reactions to food and medications. Vital signs obtained and BP noted to be in 150s/90s, Hr in 90's, temperature and oxygen saturation were both within normal limits. Employee denied any feeling of swelling of face or throat, but was taken to emergency department onsite for further evaluation as her numbness continued to persist past 30 minutes observation. Employee reported that she was triaged only and was in lobby for about 2.5 hours after which time she left since she felt her symptoms were improved. She called her PCP when she arrived home and was instructed to take 25 mg of Benadryl orally. Employee reported that her symptoms completely resolved after that and that she had no subsequent symptoms.
47 2021-02-03 tingling Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressu... Read more
Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressure
47 2021-02-04 weakness, numbness Body pain Diarrhoea Numbness of right arm Weak and tired
47 2021-02-04 discomfort, tingling, numbness 2nd dose: Pt c/o "numbness down my arm and it feels cold down to my hand" left arm, "intermittent ... Read more
2nd dose: Pt c/o "numbness down my arm and it feels cold down to my hand" left arm, "intermittent numbness". Tingling felt like crawling ants on arm. "more numb in my last two fingers", "discomfort in nape of neck, lightheadedness, and tunnel vision". Patient given 8oz of fluids, PO. BP: 180/105. No medications administered. Transported to ED. Recovered night of 1/16/21.
47 2021-02-04 feeling cold Sever chills, fever, feeling of being cold, headache, exhaustion and terrible body aches
47 2021-02-04 feeling cold Fever recorded was 101.6/fever recorded was 101.9; body aches; feel chill/fet chill; This is a spont... Read more
Fever recorded was 101.6/fever recorded was 101.9; body aches; feel chill/fet chill; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247; expiration date not provided), via an unspecified route of administration (anatomical location: left arm) on 20Jan2021 at 09:20 am at SINGLE DOSE for covid-19 immunisation. Patient's medical history was reported as none. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient has no allergies to medications, food, or other products. Patient reported that she got the vaccine at 9:20 am on Tuesday (20Jan2021). Patient started to feel chill at 08:30 pm. Fever recorded was 101.6 at 11 pm. Patient took paracetamol (TYLENOL extra strength). Felt chill again and fever recorded was 101.9. Took again 1 extra strength paracetamol. Felt chill and fever at 11 am. It was reported that patient also experienced body aches on 20Jan2021 at 08:30 pm. The patient underwent lab tests and procedures which included body temperature with result of 101.9 and body temperature with result of 101.6 on 20Jan2021. The events were assessed as non-serious. Outcome of the events was unknown.
47 2021-02-04 feeling jittery getting jittery; tense; antsy; keyed up; blood pressure: 154/85; This is a spontaneous report from ... Read more
getting jittery; tense; antsy; keyed up; blood pressure: 154/85; This is a spontaneous report from a contactable pharmacist, reporting for herself. A 47-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via an unspecified route of administration on 14Jan2021 at 16:30 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included Stage IV endometriosis, AVNRT/SVT cardiac arrhythmia, survivor of clear cell renal cell carcinoma (treated 2010), allergies: Lupron (rash), environmental allergies (grasses, trees, weeds, molds, animal dander), all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Drospirenone, ethinyl estradiol, betadex clathrate (YAZ), levonorgestrel (MIRENA), cetirizine hydrochloride (ZYRTEC), metoprolol succinate (TOPROL XL), and unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 at 21:30, the patient starting getting jittery, tense, antsy, "keyed up". She took her blood pressure and it was 154/85. One hour later it was 148/89. Two hours later it was 158/88. The next day, on 20Jan2021 (day 6 post-vaccine), the blood pressure reading in the morning upon arising was 154/86. At 5 pm, it was 166/91. She doubled up on metoprolol succinate (TOPROL XL) dose, which didn't seem to alter the blood pressure at all, based on the home monitor readings. On day 7 post-vaccine (21Jan2021) it is as if the preceding day with the elevated blood pressure never happened; she felt perfectly fine and normal. Day 7 post vaccine, blood pressure resumed normal levels (115-120/70-80). The patient did not receive treatment for the events. The clinical outcome of getting jittery, tense, antsy, "keyed up", and blood pressure: 154/85 was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
47 2021-02-04 pain in extremity Severe arm pain and arm sensitivity changes
47 2021-02-05 muscle spasms 12 hours after second injection, localized swelling and edema of right arm and shoulder extending to... Read more
12 hours after second injection, localized swelling and edema of right arm and shoulder extending to right ribcage. Fourteen hours post-injection (2nd dose only)Fever of 103.5, myalgia, chills, stiff neck, sheadache, and significant sharp pain in joints, muscle cramping in legs and arms. After treating with 600 mg ibuprofren, fever was reduced to 101.0. Fever recurred four hours later with profuse sweating. 600 mg of ibuprofren taken which again reduced fever to 99.8. At 24 hours post injection, swelling of ribcage and shoulder is subsiding, fever of 99.9. Having survived septic shock in 2011, I can say this felt the same. It was extremely painful.
47 2021-02-06 weakness, pain in extremity, numbness, cold sweat 2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing w... Read more
2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.
47 2021-02-06 cold extremities, feeling cold By 2nd night my hands and feet were freezing.. I felt extremely cold but had no fever and didn't fe... Read more
By 2nd night my hands and feet were freezing.. I felt extremely cold but had no fever and didn't feel sick.. By third night my lower back down thru my hamstrings and half muscles were weak and extremely sore. It felt like I overworked my muscles but I didn't workout or strain myself during this vaccination and thereafter. Hopeful few days soreness will be gone. Just wanted to report what I'm experiencing so far. Used heating pad and advil.
47 2021-02-07 difficulty speaking #1 The injection site was sore, red, and hot to touch, the site then had a large lump under the surf... Read more
#1 The injection site was sore, red, and hot to touch, the site then had a large lump under the surface of the skin, then it was black and blue. From start to finish from the redness to the bruising was about 3 days. #2 Sore throat, followed by hoarseness and then ultimately loosing my voice, body aches, headache, fever and chills with the fever lasting 4 days and ranging from 99.5 to 106.1. Also have had a runny nose, followed by congestion with a course and constant productive cough. I still have all the symptoms listed above today 02/08/2021 except the fever, chills and body aches.
47 2021-02-07 flushing Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushe... Read more
Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushed feelings. Patient stated she did not eat breakfast and has not been drinking water. Patient also states she has a history of panic attacks, anxiety, IBS, Cevo. Patient did have c/o a slight headache however, felt it was due to lack of water intact today. Patient sat for remaining 30 minute observation with nurse and provider on duty and was given water. At the end of the 30 minutes patient had decreased symptoms and stated her husband drove her. Provider gave ok for patient to take a prescribed Lorazepam when arriving home today. Patient discharged home after 30 minute observation period was complete with husband.
47 2021-02-07 pain in extremity she felt pain in the arm and body; she felt pain in the arm and body; inflammation in the injections... Read more
she felt pain in the arm and body; she felt pain in the arm and body; inflammation in the injections site; fever; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 21Jan2021, she felt pain in the arm and body, inflammation in the injections site and fever and had taken 6 Tylenol tablets as treatment, but the fever has not been fully controlled. The outcome of event fever was not recovered; for other events was unknown. Information about lot/batch number has been requested.
47 2021-02-07 pain in extremity Very sore arm leading up to the shoulder, body aches especially neck area, chills, tiredness.
47 2021-02-07 tingling, numbness Numbness in left leg severe enough that could not walk properly. Heart was racing per patient, Pul... Read more
Numbness in left leg severe enough that could not walk properly. Heart was racing per patient, Pulse felt normal approx. 80bpm. Left foot was tingly. Wheelchaired to Emergency Room.
47 2021-02-07 tremor Patient complained of visual changes, shakiness, N/V and fatigue. Remained in Observation Area (cli... Read more
Patient complained of visual changes, shakiness, N/V and fatigue. Remained in Observation Area (clinic) extended by per RN. VS assessed frequently. EMS called due to patients condition not improved but worsening and transported to ER. Patient noted similar reaction with first vaccine. Patient had COVID in September.
47 2021-02-08 weakness Light headed. Heart palpitations. Faint. Headaches. Weakness. Dizzy. Since vaccine. Been seen by u... Read more
Light headed. Heart palpitations. Faint. Headaches. Weakness. Dizzy. Since vaccine. Been seen by urgent care and doctors. Wearing heart halter monitor. Symptoms have not gone away. Insomnia worse. Started 12 hours after vaccine. All labs normal 5 days before and all labs normal now., but still having symptoms. Missing work.
47 2021-02-08 hot flush, cold sweat Having redness, swelling and site of injection is warm to the touch still today 2/9 .. 2 days after ... Read more
Having redness, swelling and site of injection is warm to the touch still today 2/9 .. 2 days after injection. Yesterday 2/8 I had flu like symptoms all day including hot flashes followed by cold sweats, body aches all over body and extreme fatigue.
47 2021-02-08 numbness high blood pressure, dizziness, numbness of leg
47 2021-02-09 weakness Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart ... Read more
Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart rate racing; injection site pain; This is a spontaneous report from a non-contactable consumer (patient herself). A 47-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration (left arm), on 21Jan2021 16:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever up to 102.5, nausea, dizziness, muscle aches, joint aches, headache, fatigue, weakness, heart rate racing, and injection site pain - all on 22Jan2021 02:00. No treatment was received for the events. The patient had not recovered from the events at the time of the report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
47 2021-02-09 burning sensation A mild rash began to develop on chin and neck within 48 hours and beginning on day 3 post vaccine, t... Read more
A mild rash began to develop on chin and neck within 48 hours and beginning on day 3 post vaccine, the rash developed bumps over the chin and upper lip with intense itching. The rash worsened in severity over the next week resulting in constant burning and itching preventing sleep. It is now two weeks and the rash had not improved.
47 2021-02-09 involuntary muscle movements Mild headache, mild vertigo, aches and pains, in particular upper body joint pain through the should... Read more
Mild headache, mild vertigo, aches and pains, in particular upper body joint pain through the shoulders (that felt different from fibro fog), and congestion. Waking up the next day I had some pretty severe congestion and was experiencing gross motor control problems, I felt like everything was in slow motion. The next day I woke up and the body pain was much better. I was fatigued. Cognitively, I was not thinking straight. Waking up Tuesday, I was still tired but acting more like myself with a mild headache.
47 2021-02-09 migraine The day after the 1st shot I developed terrible Migraine headaches that lasted 2 days. The afternoon... Read more
The day after the 1st shot I developed terrible Migraine headaches that lasted 2 days. The afternoon of the 2nd shot I felt extremely dizzy. Friday night, I started to develop nausea, then I got diarrhea and drive heaving. Overnight I had severe pain in my legs, calves, back, hips. Advil did not help the pain. I was up all night with the pain. My joints felt like they were on fire and it hurt to walk, bend and even to lay down. I developed a 100.3 fever overnight that lasted throughout the day Saturday along with the body pain. I developed a migraine headache Saturday Night that lasted through Sunday. My fever broke Sunday afternoon.
47 2021-02-09 migraine Chill; fever; body aches; migraine; dizziness; soreness at injection site; headache; lymph node swol... Read more
Chill; fever; body aches; migraine; dizziness; soreness at injection site; headache; lymph node swollen on left arm pit area; This is a spontaneous report from a contactable other healthcare professional(patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302), intramuscularly into the left arm on 23Jan2021 11:45 at a single dose for covid-19 immunisation. Medical history was reported as none. Patient was not pregnant. Concomitant medication included escitalopram oxalate (LEXAPRO), riboflavin (RIBOFLAVIN), multivitamins and antihistamine (unspecified). The patient was previously administered with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El0140), intramuscularly into the left arm on 02Jan2021 12:30 at a single dose for covid-19 immunization. On 23Jan2021 20:30, patient experienced chill, fever, body aches, migraine and dizziness. On 23Jan2021, patient experienced soreness at injection site, headache and lymph node swollen on the left armpit area. The patient did not receive treatment for the events reported. Outcome of events were recovering.
47 2021-02-09 pain in extremity Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the tas... Read more
Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the taste and smell; Weird taste in her mouth; Headache; Swelling in her throat; Injection site pain; Muscle pain; Injection site swelling and redness; Injection site swelling and redness; Swollen lymph node; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 24Jan2021 at a single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medications were not reported. It was reported that the patient got the COVID-19 vaccine shot on 24Jan2021. When she sat there for 15 minutes, she got a weird taste in her mouth and got a headache. At 2 PM she still had a headache and she lost most of the taste and smell; at 4 pm she was sick to her stomach; by 5:15, her arm and head hurt badly, the taste in her mouth was like super weird but it was not exactly metallic taste it was weird bizarre taste she never had before. Her smell came back. She was extremely nauseated and had a bad headache. She stated that all of her symptoms were gone away except the swelling in her throat. She further stated she called the hospital and stated she got injection site pain, headache, and muscle pain. She also got injection site swelling and redness, nausea, swollen lymph node and a headache and the weirdest part that really bothered her was the strange taste in her mouth. She got some of the smell and taste back and now it's gone; it's really bizarre like the injection site pain, the headache everything was gone literally gone. The only things that was still hanging on was her lymph nodes and throat. The second due dose of vaccine was on 14Feb2021. The patient has not recovered from swelling in her throat and swollen lymph node, and has recovered from other events. Information on the lot/batch number has been requested.
47 2021-02-09 pain in extremity 8-10 hrs post injection bad arm pain; with in 16-24 hours cold symptoms that are getting worse; we a... Read more
8-10 hrs post injection bad arm pain; with in 16-24 hours cold symptoms that are getting worse; we are now over a week a later and still runny nose; sore throat; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 47-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3246), at age 47 years, via an unspecified route of administration on the left arm, on 16Jan2021 13:15, at single dose, for COVID-19 vaccination. Medical history included low level diabetic, knee issues and milk allergy from an unspecified date. Patient had not had COVID prior to vaccination. Patient had not had other vaccine in four weeks. Concomitant medication included calcium (CALCIUM), fish oil (FISH OIL), glucosamine sulfate (GLUCOSAM), methylsulfonylmethane (MSM [METHYLSULFONYLMETHANE]), magnesium (MAGNESIUM) , cetirizine hydrochloride (ZYTREC) from unspecified dates. The patient previously took ASPRIN and was sensitive to it on an unspecified date. It was reported that on 16Jan2021 21:30, 8-10 hrs post injection bad arm pain, like yellow fever shot, then with in 16- 24 hours cold symptoms that are getting worse, at the time of report, over a week a later and still runny nose, and sore throat, no symptoms prior to shot. There was no treatment for the events. Patient was not tested for COVID post vaccination. Facility type vaccine: Doctor's office/urgent care. The outcome of the events was recovering.
47 2021-02-09 tingling, weakness Fatigue; headache; weakness; nausea; tingling on right side of body; This is a spontaneous report fr... Read more
Fatigue; headache; weakness; nausea; tingling on right side of body; This is a spontaneous report from a contactable other health professional (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (right arm) on 22Jan2021 17:30 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included lisinopril from an unspecified date for an unspecified indication. The patient previously took Codeine and Compazine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 (13:00), the patient experienced fatigue, headache, weakness, nausea, and tingling on right side of body. There was no treatment received for the adverse event. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
47 2021-02-09 tremor Two days later I developed fever and shaking and headache; Two days later I developed fever and shak... Read more
Two days later I developed fever and shaking and headache; Two days later I developed fever and shaking and headache; Two days later I developed fever and shaking and headache; This is a spontaneous report from a contactable healthcare professional. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on her left arm on 22Jan2021 09:00 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included terconazole, duloxetine hydrochloride (CYMBALTA), fluconazole. The patient reported that two days later, she developed fever and shaking and headache; all on 24Jan2021 11:00AM. No treatment was received for the events. The outcome of the events was not recovered. Information on the Batch/Lot number has been requested.
47 2021-02-09 tremor Chills started by 2 pm on 2/9/21; extreme chills and shaking by 4 pm. Body aches , low fever, joint ... Read more
Chills started by 2 pm on 2/9/21; extreme chills and shaking by 4 pm. Body aches , low fever, joint pain, and fatigue came after. By 7 pm, I had all of these symptoms, plus nausea and no taste. Today (2/10/21) by 4 pm, the chills and low grade fever were gone but still have body aches, joint pain, and fatigue.
47 2021-02-09 tremor Muscle pain from the injection occurred and lasted approximately 4 days. In addition, about 24 hour... Read more
Muscle pain from the injection occurred and lasted approximately 4 days. In addition, about 24 hours after receiving the vaccine, I began having uncontrolled tremors that lasted about 12 hours. I also had a fever and fatigue which lasted about 3 days.
47 2021-02-10 migraine Migraine; This is a spontaneous report from a contactable other healthcare professional (patient). A... Read more
Migraine; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262), intramuscular in the left arm on 24Jan2021 08:30 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included temazepam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced migraine on 25Jan2021 09:00. No treatment was received for the adverse event. Outcome of the event was not recovered. The event was considered non-serious.
47 2021-02-10 pain in extremity her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; f... Read more
her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; fever; her right carotid on her neck felt swollen; right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt; tired and achy; tired and achy; feeling sick; muscle and joint pain; muscle and joint pain; cough; the back of her ribs hurt; Nausea; she is having shooting pains in different spots; This is a spontaneous report from a contactable nurse reporting for self. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number EL3249, via an unspecified route of administration from 25Jan2021 14:00 (at the age of 47 years old), Dose 2, as a single dose in the left arm for COVID-19 immunization. Medical history included she had her tonsils out on an unknown date. She was a nurse that works with COVID patients; she got tested twice last week (Jan2021), both were negative. She had no pre-existing medical conditions. She has never had a problem with vaccines. There were no concomitant medications. The patient previously received dose 1 of BNT162B2 on 04Jan2021 (Lot # EX9231) and experienced no reaction then. The patient had the second dose of the Pfizer vaccine around 2 PM yesterday (25Jan2021) and she kept moving around in bed and feeling sick last night. That night she was just tired and achy but she thought that could just be from working. She went to bed early and she woke up around 1:50 or 2 AM with chills so she went and got a thermometer. She woke up at about 2 AM (26Jan2021) with a 103 fever and chills and her right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt. Her skin just burns; she went to take a shower. With the skin burning she knew it was sore to touch but when she got in the shower, that was when she noticed it hurt. She was really achy; her legs were aching and she was having shooting pains in different spots. She commented that she called out today (26Jan2021), she never calls out; all she wanted to do was take a shower and she wondered if she needed to go to the doctor. Her skin burns even when she was showering; every part her skin burns. She was also having muscle and joint pain and cough and the back of her ribs hurt (Jan2021). The other thing was nausea (Jan2021). The fever and chills were persisting and were about the same. She was hoping for it to go down so she could go to work to tomorrow (27Jan2021). The clinical outcome of the fever, chills, and her right carotid on her neck felt swollen and hurt was not recovered. The clinical outcome of feeling sick, tired and achy, face feels swollen, skin burning, muscle and joint pain, cough, back of her ribs hurt, nausea, and shooting pains in different spots was unknown. The reporter states she thinks what she is reporting was directly related to the product.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-02-11 numbness, flushing, feeling hot Patient became flushed, hot, severe headache, face was numb. Blood pressure was elevated 183/94, hea... Read more
Patient became flushed, hot, severe headache, face was numb. Blood pressure was elevated 183/94, heart rate 119 bpm. Moved patient to cooler area of clinic. Blood pressure 5 minutes later, was 170/83, heart rate 105 bpm, headache was not as severe. Patient remained in clinic for 30 min. Blood pressure was 125/73. Patient felt well enough to leave.
47 2021-02-13 weakness After very little reaction on the day of besides some weakness and fatigue. The next evening I devel... Read more
After very little reaction on the day of besides some weakness and fatigue. The next evening I developed a swollen supraclavicular lymph node on the right side (same side as injection site) It became hard and painful.
47 2021-02-14 cold sweat 0944 pt c/o lightheadness, sweaty, clammy. physician at vaccine clinic saw pt at that time. b/p 129/... Read more
0944 pt c/o lightheadness, sweaty, clammy. physician at vaccine clinic saw pt at that time. b/p 129/70 HR 94 O2 100% on room air. pt was laid down flat on a stretcher. 0946 pt states felt better. b/p 123/71 hr 86 O2 99% 0948 pt states better 123/82 hr 90 O2 99% 0952 b/p 128/78, hr 97, O2 99% 0955 b/p 122/75, hr 95, O2 100%. given water. physcian saw pt again and discharged pt.
47 2021-02-14 feeling cold cold shivers, headaches, dizziness, nausea, temperature
47 2021-02-14 feeling cold The same day coming from Laredo, TX to Midland, TX exp body aches in my back. I started feeling cold... Read more
The same day coming from Laredo, TX to Midland, TX exp body aches in my back. I started feeling cold chills took 2 Tylenol on that Monday. On Tuesday around 3:00 am started chills (bilateral hands), body felt cold and very hard for me to walk. Due to the chills I was taking warm showers (10 mins) for my body to get to regular temp. I went to Urgent Care get tested. The following Friday I felt really,really bad I thought something else was going on with me. I called the Urgent Care again I began to have fever was told might be side effects from vaccine. I followed up with PCP on 1/14 advised to take the second dose and continue taking vitamins.
47 2021-02-15 weakness, facial pain With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose ... Read more
With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose I had severe fatigue, joint pain, my wrist and my armpit was budging, I noticed swelling my clavicle on my left side, chills, and dizzy. I had to miss work for 2 days. I had to lay bed in for 2 days. By 3rd it was much improved but I still feel weak. About 4 days after receiving the vaccine I was back to feeling my self. On 2/14-15/2021, my face was itching, I scratched it, and there is a small abrasion. My face started to swell, around 2AM this morning I had to go to the ER because my eyes were getting small, the swelling was getting worse. I also had bumps that looked like hives on my face, there was some fluid coming out of my face. I went to early this morning, The ER doctor said she thinks it is not infected she thinks it is inflamed. I did not mention that I had recently received the COVID vaccine and did not realize that it may be linked to the vaccine until later in the day. She prescribed Hydrocortisone 0.5 % cream and Mupirocin 2% cream. Since I have been home the ER the swelling has worsened. My face is painful, it feels like an orange peel when you touch.
47 2021-02-15 hot flush I started 2/11/21 at 11:45 am to have stomach cramps. The stomach cramps started mildly. Around 1:30... Read more
I started 2/11/21 at 11:45 am to have stomach cramps. The stomach cramps started mildly. Around 1:30 pm, the stomach cramps became very intense followed by hot flashes and nausea. I vomited twice and caused my head to ache. I decided to be observed. Once I arrived at clinic, I started to have chills and muscle pain.
47 2021-02-15 pain in extremity Arm was very achy the first 12-14 hours. Kept me awake that night. Injection site was very sore to... Read more
Arm was very achy the first 12-14 hours. Kept me awake that night. Injection site was very sore to touch. After 5 days, still have severe joint pain in left shoulder (side which injection was given) which is constant.
47 2021-02-15 tingling Tingling in arms/hands and legs/feet
47 2021-02-15 restless legs syndrome Approximately 12 hours after I received the injection, I started to experience muscle and joint pain... Read more
Approximately 12 hours after I received the injection, I started to experience muscle and joint pain. Soon after the pain started, I began feeling short of breath and feverish. Vitals were checked and I did not have a fever, but heart rate was elevated and oxygen saturation was low. Around 9:00 am, I began having restless leg symptoms in addition to other symptoms. I took oral Benadryl around 10:00 am and restless leg, tachycardia and low oxygen saturation began to subside. Muscle/joint pain and exhaustion continued for a couple days.
47 2021-02-16 fibromyalgia Tenderness under right arm began on Fri. Feb. 12. The next day, the pain had increased enough that I... Read more
Tenderness under right arm began on Fri. Feb. 12. The next day, the pain had increased enough that I looked in the mirror, to find a moderately large swelling. It increased in size overnight Sat. Feb. 13. Sunday, the swelling reduced a bit, to the same size I found it originally. It has remained that size - a decent golf ball - since then, Sun. Feb., 13. Though localized tenderness in lymph nodes has decreased quite a bit, I'm now in a significant Fibromyalgia flare (which could also be explained by a change in weather).
47 2021-02-17 feeling hot, tenderness AFTER MODERATE MUSCLE AND JOINT PAIN, AND INCREASED TIREDNESS THE FIRST 45 HOURS AFTER THE VACCINE S... Read more
AFTER MODERATE MUSCLE AND JOINT PAIN, AND INCREASED TIREDNESS THE FIRST 45 HOURS AFTER THE VACCINE SYMPTOMS BECAME LOCALIZED TO PRE-EXISTING INJURY LOCALS (HIP/BACK). AT APPROXIMATELY 1930 HOURS ON THE 5TH DAY AFTER VACCINATION I BEGAN TO HAVE SEVERE INTESTINAL DISCOMFORT LEADING TO DIARRHEA. SHORTLY THEREAFTER MY ENTIRE BODY BROKE OUT IN A NON-ANAPHYLACTIC ALLERGIC REACTION RASH. MY ENTIRE BODY WAS BRIGHT RED, WARM AND EDEMIC TO THE TOUCH, AND ITCHED. I BEGAN TO HAVE THE CHILLS AND EXPERIENCED SEVERE CHILL TREMORS. MY BODY WENT INTO MILD SHOCK WITH NO CAPILLARY REFILL ON MY FINGERS OR TOES. I TOOK TWO FULL DOSES OF 25MG BENADRYL (SPLIT TABLETS- 50MG TOTAL) AND 1 DOSE ALLEGRA-D [60MG FEXOPHENADINE HCL/120MGPSEUDOEPHEDRINE HCL] (IN ADDITION TO THE 24 HR ALLEGRA [180MG FEXOPHENADINE HCL] DOSE TAKEN AT 14OO HOURS) WITHIN 20 MINUTES OF ONSET. AFTER THE SHOCK PASSED AND THE FIRST DOSAGE OF BENADRYL WORE OFF I TOOK ANOTHER 50MG AT 0030 HOURS AND AGAIN AT 0530 HOURS DUE TO A RECURRANCE OF REDNESS, ITCHING, AND LOCALIZED EDEMA. 25MG DOSE OF BENADRYL AND 1 24 HR ALLEGRA TAKEN AT 1300 HOURS AND ANOTHE BENADRYL AT 1900 HOURS THE FOLLOWING EVENING.
47 2021-02-17 flushing I experienced a rash in my face. It looked like mosquito bites almost. The normal pain on the inject... Read more
I experienced a rash in my face. It looked like mosquito bites almost. The normal pain on the injection - red on outside. Whole arm was red and swollen. That lasted several days. Next day after vaccine, Inside of my arm, I noticed rash (looked like chicken pox/mosquito bites) and then it went to chest, abdomen and legs. The rash continued. My face was flushed and had a 99.9 fever. I had foggy brain and chest pain (started day after the vaccine). The chest pain would last about a minute - I monitored my heart rate. From sitting down my heart rate when up to 120 and down to 37. This occurred for four days - four - six times a day. By the 3rd day after vaccine, I started feeling worse. I experienced dizziness, nausea, couldn't think, was disorientated, rash on my body, no appetite, couldn't sleep well and had no energy and chest pain - was in bed for next three days. I didn't call my Dr right away, I was monitoring the chest pain while I rested. That resolved (chest pains) by Saturday. The rest continued. My Monday, I called Public Health and they advised to call my DR. Spoke to Dr. on 11th. On the 12th, I had a telehealth appt with him. On the 13th had an EKG done. Everything normal on EKG. I continued feeling dizzy and no energy. I didn't work until Jan 19th. On the 20th, I felt foggy brain and rash wasn't gone and I went back to my doctor on January 21 and he put me off work for another week. At this point, within the last few days, my energy is back and rash is gone - I do still have dark spots on back and legs from the rash. On January 25th, I got the second dose. (The rash kind of flared back after second dose but nothing as bad.)
47 2021-02-17 hot flush, weakness **Note - reported wrong lot number on report #309074 - the correct lot number EL1284 (1st dose) - ... Read more
**Note - reported wrong lot number on report #309074 - the correct lot number EL1284 (1st dose) - 1st dose - forgot to state - needle sharp pain in the back of my neck and I felt it on my left side of my body - this occurred right away after the injection and it lasted for about 30 seconds.** 2nd dose report: was not as severe exp.; some swelling , pain and redness on arm around injection which lasted 2 days. I experienced hot flash like (face would turn red) - which lasted 5-10 min. When I had the hot flashes the rash would appear as more rash. It wasn't causing me a lot of itchiness. Second day, turning brown and kind of peeling skin off. This lasted for the first week (the hot flashes with the increased rash). The highest my fever went to 100. I had some foggy brain and overwhelmed with thinking. Symptoms resolved mostly within the first week. I was back to work by the 29th of January. I could think more clearly and every day I was getting more energy. I am usually someone who has a lot of energy and I exercise. I didn't have energy to exercise. For the whole month of Jan and the first two weeks of February, I didn't really exercise. Just starting to this week. Dr. visit in person on January 28 and he prescribed Triamcinolone 0.1%. Urine test - next month to recheck after testing prior to dose 2 of vaccine but after receiving dose 2 of vaccine.
47 2021-02-17 numbness, nerve pain My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, g... Read more
My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, gums, and inside lips); sores in nostril; sores on nose and lips; sores on nose and lips; Face swelled significantly on my left side; pink eye; severe headache; sinus pain; jaw main and numbness in my molars; severe shooting nerve pain in my front teeth; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 23Jan2021 18:45 at a single dose for covid-19 immunization. Medical history included breast cancer survivor as of 11Sep2019. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), clonazepam, anastrozole (ARIMIDEX), vitamin D3, calcium, vitamins NOS (MULTIVITAMIN), "It Works" and "Fat Fighter". The patient previously took fentanyl but had allergies. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph node in her neck swelled to the point it stuck out like a robin egg. It was mentioned that it was more swelled there as well and super sensitive to touch. These reactions occurred only on left side of her face, sores in mouth (roof, gums, and inside lips) and sores in nostril. She had sores on nose and lips. The patient mentioned that her face swelled significantly on her left side. She had pink eye, severe headache, sinus pain, jaw main and numbness in her molars, severe shooting nerve pain in her front teeth. The events were considered as non-serious and adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since vaccination. The events required treatment for the adverse events that included Keflex, Bactroban, prednisone, Valtrex, and lidocaine viscous-aluminum &magnesium hydrAM. The outcome of the events was recovering.
47 2021-02-18 burning sensation After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 4... Read more
After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 48 hours of the second injection on 1/8/2021, I had angioedema facial swelling on the lids of my eyes bilaterally, facial burning- lips, nose, and right side of face, as well as the upper chest rash. Tried cool compresses, ibuprofen and rest however did not go away. Went to employee health, threw away all my make up incase, prednisone taper and antihistamine QD, eat clean, lots of water. The swelling went away after a few days of cool compresses and when on 10 mg of the prednisone taper, it came back. Went to PCP this time and gave me dexamethasone injection, prednisone taper, antihistamine BID and continue all other o
47 2021-02-19 facial pain my face swollen and painful
47 2021-02-19 muscle spasms Diarrhea with severe cramping.
47 2021-02-19 pain in extremity 2nd dose (1st dose received 1/22/21 Pfizer Lot# EL3247): Received 2nd dose 2/18/21 at 1900. 2/19/2... Read more
2nd dose (1st dose received 1/22/21 Pfizer Lot# EL3247): Received 2nd dose 2/18/21 at 1900. 2/19/21 woke up at 0700 with chills but afebrile. Went to work - felt fatigue and brain fog throughout the day. At 1000 experienced left arm soreness that resolved by 1900. At 2100 experienced headache, nausea & fatigue and fell asleep very early. Woke up at 0300 with increased headache and chills - remain afebrile. Menstrual cycle started 2/19/21 AM - very heavy flow which is unexpected, as cycles have been normal.
47 2021-02-20 tingling, flushing Had reaction 18 min after vaccination. Flushing and rash on upper chest, neck and face. Tingling in... Read more
Had reaction 18 min after vaccination. Flushing and rash on upper chest, neck and face. Tingling in whole body. Throat "felt funny", but only noted after 25 mg of Benadryl. Symptoms resolved within 10 minutes - chest was clear, HR was normal on exam - slight erythema on upper chest and cheeks, no lip swelling. Oropharynx was clear.
47 2021-02-20 speech disorder throat and tongue swelled, but not enough to cause breathing problem, just enough to make it hard to... Read more
throat and tongue swelled, but not enough to cause breathing problem, just enough to make it hard to talk. Resolved after a week. Developed red, bumpy, itchy rash on back of both hands and lower arms. Ended up scratching to point of bleeding. Rash resolved after 2 weeks and benadryl. Felt irritable for a full week. NEVER felt fluish, just the swollen throat and rash on back of hands and lower arms and irritableness.
47 2021-02-20 tremor, pain in extremity Body and hands trembling, headache, fatigue, arm soreness
47 2021-02-21 flushing, numbness About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, stron... Read more
About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, strong metallic taste in mouth, felt flushed and HR was elevated. Received 50mg of Benadryl.
47 2021-02-21 pain in extremity sore arm x2 days; This is a spontaneous report from a contactable consumer (patient). A 47-year-fema... Read more
sore arm x2 days; This is a spontaneous report from a contactable consumer (patient). A 47-year-female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Jan2021 16:15 (lot number: el3248), via an unspecified route of administration in the right arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history was not reported. The patient's concomitant medication included hydrochlorothiazide, quinapril hydrochloride (ACCURETIC). The patient did not receive other vaccines within four weeks. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient experienced sore arm x2 days on 21Jan2021 at 07:00 AM. The patient did not received treatment. The consumer assessed the event as non-serious. The outcome of the event was recovered in 23Jan2021. No follow-up attempts are possible. No further information is expected.
47 2021-02-22 migraine with aura Onset of migraine visual aura and nausea. Migraine headache did not occur while the patient was un... Read more
Onset of migraine visual aura and nausea. Migraine headache did not occur while the patient was under our observation. Patient thinks the aura may have been triggered by bright lights in observation room. No medications given.
47 2021-02-23 weakness, pain in extremity One day after vaccine-lethargy, no energy Two days after vaccine- lethargy, no energy, joint pain in... Read more
One day after vaccine-lethargy, no energy Two days after vaccine- lethargy, no energy, joint pain in arms and hands, swollen face Three days after-same symptoms Four days after-same symptoms but lethargy worse and some dizziness
47 2021-02-23 pain in extremity Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelli... Read more
Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM, the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose. The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.
47 2021-02-24 weakness I had Covid-19 after my 1st vaccine. I experienced shortness of breath, fever, body aches, headaches... Read more
I had Covid-19 after my 1st vaccine. I experienced shortness of breath, fever, body aches, headaches, nausea, diarrhea, cough and also had loss of energy.
47 2021-02-24 fibromyalgia Caused a flare up of fibromyalgia pain. Has lasted over a week. Pain is 8-[ out of 10. Headache tha... Read more
Caused a flare up of fibromyalgia pain. Has lasted over a week. Pain is 8-[ out of 10. Headache that lasted over a week
47 2021-02-24 tingling Extreme myalgia and paresthsias, Pain 9/10. Similar presentation patient experienced with past menin... Read more
Extreme myalgia and paresthsias, Pain 9/10. Similar presentation patient experienced with past meningitis event. Insomnia, vision changes, agitation. Prednisone is helpful in making pain bearable. Gabapentin started today. Labs pending.
47 2021-02-25 migraine sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit,... Read more
sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was more diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: May2021), via intramuscular route of administration on 26Jan2021 at 11:30 at 0.3 mL, single on the left arm for COVID-19 immunization. Medical history included ongoing migraine and vomiting. Concomitant medications included ongoing sumatriptan succinate (IMITREX) for migraine, ongoing nadolol for migraine, ongoing sertraline for migraine, and ongoing ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). On 26Jan2021 at 13:00, the patient experienced really bad migraine. The patient always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea. The husband does not know if it was because of the shot or if it was because of the warm front that they are receiving because sometimes that can trigger her migraines. The husband reported that it was pretty typical for her and she will sleep with a fan on, but today she is actually covered up (for clarification) and does not want the fan on. Patient also started sweating and got nauseated on an unspecified date. The husband wanted to know if he needs to take her to the doctor. The outcome of the events really bad migraine and diarrhea was not recovered while the other events was unknown.
47 2021-02-25 tingling Around 4:00pm-4:15pm, began pin and needles discomfort in joints between fingers on right hand. Betw... Read more
Around 4:00pm-4:15pm, began pin and needles discomfort in joints between fingers on right hand. Between 4:15pm-4:30pm, the palms of both hands, and my left wrist began to itch uncontrollably. Reported to EMT on duty to exam. Experienced elevated blood pressure of 163/93. No itching of throat nor any other body parts. Was advised to take Benadryl.
47 2021-02-28 discomfort, muscle spasms At roughly 2:30pm, started with nausea and chills, went home went to bed. Severe muscles cramping... Read more
At roughly 2:30pm, started with nausea and chills, went home went to bed. Severe muscles cramping and soreness. Went to ER for this was perscribed naproxen for inflammation. Still nothing helped. Went back to ER with elevated heart rate and BP due to the discomfort was accused of being a pill seeker. I just want the pain and muscle cramps to stop. I hurt from head to toe.
47 2021-02-28 feeling cold Perfectly fine until about 25 minutes after the injection. Then, nausea and dizziness started, foll... Read more
Perfectly fine until about 25 minutes after the injection. Then, nausea and dizziness started, followed by burning and itching on both sides of tongue. Then the back of the throat started hurting, and it became hard to swallow, followed by becoming very cold, chills, and dry mouth. Finally the skin area around mouth and lips and up through the cheek/jawline became very itchy. It was not anaphylaxis because my breathing was okay. We drove home, and I took two Benedryl (50 mg) upon arriving home. Within 2 hours all symptoms subsided with the exception of a nasty headache. Today, I am fine, but just have a sore arm at the site.
47 2021-02-28 numbness, tingling Tingling in hands bilaterally began at 15min mark post vaccination. Approx 15min later tingling trav... Read more
Tingling in hands bilaterally began at 15min mark post vaccination. Approx 15min later tingling traveled down to legs bilat. Approx 15min after that, tingling traveled into face around cheeks and lips bilaterally. Patient noted numbness around face and lips. Pulse 70, Resp 14, no BP taken due to equipment failure. Recommended patient seek further medical observation by ER or Urgent Care, patient verbalized understanding.
47 2021-03-01 coordination abnormal Low fever set in about 14 hours after vaccine, along with chills and fatigue. Slept a lot for about... Read more
Low fever set in about 14 hours after vaccine, along with chills and fatigue. Slept a lot for about 48 hours. Nausea and decreased appetite, dry heaving and minor vomiting. Nausea persisted for about 4 days after vaccine. Mild headache as well. Treatment was just rest and easily digestible foods. Recovering slowly.
47 2021-03-02 weakness Chills, rapid Heart beat, weakness, fever
47 2021-03-02 pain in extremity I had my 2nd dose of Phizer Covid Vaccine on February 19, 2021 and had it in my left arm. My first ... Read more
I had my 2nd dose of Phizer Covid Vaccine on February 19, 2021 and had it in my left arm. My first dose 3 weeks prior was in my right arm. I did not experience any side effects from the shot for 4 days. I woke up on Tuesday, February 23rd and had pain in my right arm - the arm I had the 1st shot in, not the 2nd! I continued to have pain in my right arm for several days and then 6 days after my 2nd dose I started having extreme pain in my legs - from my knees up the back of my thighs for two days. Then 8 days after my 2nd dose my other arm became very sore, the arm I had the 2nd dose in. So both arms are sore and the lymph nodes under the arms are tender. Today I am 11 days out since my 2nd dose and I woke up and could barely lift my left arm. I have pain in both arms and lymph nodes. I went to my family doctor and he does not have any answers for me. I need to know if this is something I should be concerned about and if there is anything I can do to help these side effects go away. How long can this last???
47 2021-03-02 tingling, numbness numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to ... Read more
numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); felt acutely short of breath and anxious; felt acutely short of breath and anxious; numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); This is a spontaneous report from a contactable physician. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 16:00 (at the age of 47 years old) at a single dose for covid-19 immunization. Medical history included known allergies: shellfish, seasonal allergies and psoriasis. Concomitant medications included several medications in two weeks. The patient is not pregnant. The patient had no other vaccine in four weeks. On 29Jan2021 23:45, after being asleep for approximately one hour, felt acutely short of breath and anxious, which lasted less than a minute and was then followed by numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE). These events resulted in emergency room visit. The patient underwent lab tests and procedures which included PCR/nasal swab on 29Jan2021 (post vaccination) which showed negative. Therapeutic measures were taken as a result of all the events which included diphenhydramine (BENADRYL), IVF. Outcome of all the events was recovering. Information on the lot/batch number has been requested.
47 2021-03-03 numbness Tachycardia. Laying in bed watching TV, suddenly my heart was racing. I just stayed in bed and it we... Read more
Tachycardia. Laying in bed watching TV, suddenly my heart was racing. I just stayed in bed and it went away after a few minutes. Numbness in the arm: started that night and I would get numbness about every other day. Numbness lasts for about 10 hours and comes and goes throughout the day. About 6 weeks after the vaccine, i got numbness in the left leg. Now the numbness in the arm is pretty much gone but the leg numbness is there.
47 2021-03-04 weakness Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; s... Read more
Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; swelling in left armpit; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9Z61), via an unspecified route of administration on 01Feb2021 at 10:00 at a single dose on the left arm for COVID-19 immunization. Medical history included diabetes, hypertension (HTN), depression and polycystic ovarian syndrome (PCOS) all from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EJ1686) on 11Jan2021 at 10:00 on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache, lightheadedness, weakness, fatigue, muscle and joint pain and swelling in left armpit on 02Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
47 2021-03-04 feeling hot 1430 vaccine given. 1443 started feeling dizzy, light-headed, hot. b/p 140/90,hr-78,r-20, 02 sat 98%... Read more
1430 vaccine given. 1443 started feeling dizzy, light-headed, hot. b/p 140/90,hr-78,r-20, 02 sat 98%ra. 1450 cont hot and dizzy. HR-77,02 sat 98%ra. 1500 report cont hot and dizziness gone and starting to feel better. 1510 report dizziness gone and starting to feel tired. 1515 dizziness resolved, pt stood up no dizziness. b/p 142/82. hr-66, r-18, 02 sat 98%ra, 1520 pt went home with husband who is here with her. Instructed to f/u with MD prn
47 2021-03-04 numbness, night sweats, facial paralysis, feeling hot The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I ... Read more
The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I thought it could be in my head. Throughout the evening after my shot I felt a bit of contracting of leg muscles and neck/shoulder muscles on the left side of my body. The left side of my face felt noticeably warmer than the right. This was all very mild, but just noticeable. In the middle of the night, I woke up with extreme night sweats but only on the left side of my body. The next morning (today) the left side of my face is still warmer but it feels droopy and bloated and slightly "Numbish". My left eyelid feels heavy. My left cheeks feel swollen and puffy and my left gums and lips feel slightly numb. I also have a very mild headache only on the left side. This is disturbing, while it is not debilitating or painful, it is strange and makes me think I should not get the next shot. Even as I type this, my left hand feels very fatigued. I don't know who to call or talk to about this. I do not have a health care provider.
47 2021-03-06 tremor, tingling, throat numbness, numbness Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst ... Read more
Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst point about 36 hours after injection: Swelling in throat, tongue, face, lymph nodes, generalized swelling (all the way to fingers and toes). Tingling in lips, tongue, face, scalp, left leg and left arm Shaking hands and racing heart, intermittently 48 hours later Entire left hemisphere of body want numb for about three hours. I freaked out and cried. *I had the vaccine in my left bicep, and I have a pinched nerve in that shoulder, which is teemed to activate. The nerve has never caused numbness beyond my left arm before, however, Last round of trembling about 48 hours after injection 72 hours later: Left tonsil and throat and armpit lymph nodes still swollen, but markedly less. Moderate numbness in left cheek and left side of throat, but less.
47 2021-03-07 numbness, tingling Facial numbness, tingling in the nose, right ear hearing affected. Consulted with doctor's office ov... Read more
Facial numbness, tingling in the nose, right ear hearing affected. Consulted with doctor's office over the phone daily on 03/03, 03/04, 03/05.
47 2021-03-07 pain in extremity Nausea, uncontrollable chills, bone pain through out entire body, tired, sore arm, stomach cramps, h... Read more
Nausea, uncontrollable chills, bone pain through out entire body, tired, sore arm, stomach cramps, headache
47 2021-03-08 numbness I received my first COVID vaccination and woke up the next morning and I could not move my neck, my ... Read more
I received my first COVID vaccination and woke up the next morning and I could not move my neck, my shoulder hurt and my arm was numb all the way down it. The symptoms have persisted since 1/27/21
47 2021-03-08 nerve pain On 3/8/21 patient reports itchiness noted to injection site. On the following day 3/9/21, swelling ... Read more
On 3/8/21 patient reports itchiness noted to injection site. On the following day 3/9/21, swelling and redness noted to the area and feelings of slight nerve pain noted to left wrist area.
47 2021-03-08 pain in extremity Headache, tired, could not stay awake, chills, fever of 102, dizzy, sore muscles, sick at stomach, v... Read more
Headache, tired, could not stay awake, chills, fever of 102, dizzy, sore muscles, sick at stomach, vomited... started 3/5/2021 early morning, felt some better by 3/6/2021 in the morning, but still headache, sore muscles, and tired, felt significantly better morning of 3/7/2021. On 3/7/2021 injection site on left arm became red, swollen, warm, and itchy about the size of a hand, also had a similar spot on thigh about size of golf ball. Arm very sore. Redness, swelling, and warmth on arm and thigh getting better within 24-36 hours after appearing. By 3/8/2021 all symptoms seem to be gone or extremely minor.
47 2021-03-09 flushing I experienced red face/flushed face. I was already experiencing asthmatic symptoms the day before. ... Read more
I experienced red face/flushed face. I was already experiencing asthmatic symptoms the day before. I received benadryl at the vaccination site as they were concerned it was allergic. However, after follow up with my allergist/immunologist this was not determined to be an allergy. I have never had an allergic reaction to vaccinations in the past. She has cleared me to receive the second dose.
47 2021-03-09 pain in extremity I have sore joints in both hands/fingers, elbows, shoulders, ankles, and toes. The right side is wo... Read more
I have sore joints in both hands/fingers, elbows, shoulders, ankles, and toes. The right side is worse than the left. I take Advil for pain. I am uncomfortably sore. I am walking each day and we are painting our basement so those areas are getting a lot of movement.
47 2021-03-09 throat numbness Within 5 minutes of receiving my vaccine, I suddenly felt the back of my mouth, throat, and back of ... Read more
Within 5 minutes of receiving my vaccine, I suddenly felt the back of my mouth, throat, and back of my tongue feel numb. I also felt a slight nausea. The sensation lasted for about a minute. I told the staff at the hospital that was observing me. It started to subside gradually, but twice while I was still being observed the sensation came back, but not as strong and not for as long as it did the first time. I had no other symptoms. I want to add that I was not anxious about receiving the vaccine and nothing like this has ever happened to me before, but it was quite alarming at the time. I was observed for an hour in total after the shot. I was offered to go to the ER if I wanted to but I declined. It is now about 3 hours since the shot and I feel ok now just slightly tired.
47 2021-03-11 numbness, throat numbness Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, ... Read more
Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, tightness in chest and throat, numb mouth and throat and chest, blood pressure very high, difficulty breathing, fever, PVCs (detected by EKG from EMS); benadryl 62.5mg then EMS arrived and gave IV steroid 125mg; EMS transported to ED where another 25mg Benadryl was administered and Pepcid 20mg; symptoms improved enough to discharge patient
47 2021-03-11 pain in extremity, feeling cold Injection site soreness started a few hours after the initial dose. That seem to ease up after three... Read more
Injection site soreness started a few hours after the initial dose. That seem to ease up after three days, but did not resolve. Between day five and seven, the soreness continued and progress into my arm and hand. By day eight, a deep cold sensation would randomly occur at the injection site that would radiate into the hand. Rubbing in the area intensified the cold. This has continued on and off over the past 10 weeks. Constant, Chronic soreness at the injection site that radiates into the arm with episodes of cold sensation
47 2021-03-11 tremor near syncope, hypotension, shaking. Lasted 20 minutes in clinic with stable BP, HR, and SpO2 mostly... Read more
near syncope, hypotension, shaking. Lasted 20 minutes in clinic with stable BP, HR, and SpO2 mostly >96%. Dipped to 88% a few times. no respiratory symptoms, rash, or throat swelling. transferred from clinic to ED via ambulance
47 2021-03-12 depressed level of consciousness The patient reported to the pharmacy counter after her 1st dose of the COVID19 (Pfizer-Biotech) vacc... Read more
The patient reported to the pharmacy counter after her 1st dose of the COVID19 (Pfizer-Biotech) vaccination within 5 minutes stating "Guys, I don't feel good." One of the pharmacists grabbed her chair and moved it to our check out window and sat down with her to ask her what she was experiencing. I grabbed the blood pressure cuff and returned to the patient. The other pharmacist reported to me that she felt light-headed, dizzy, and that her throat was itchy. We administered 25mg of diphenhydramine (oral tablet) and gave the patient some water. We then checked her BP and it was 68/40, which prompted us to call 911 for assistance. The other pharmacist stayed with her until the paramedics arrived (~15 minutes). About 5 minutes later we rechecked her BP and it jumped to 144/90. I tried to assess the patient's coherence, which began to diminish as she was very confused and could not understand the questions we were asking her. About 1 minute before they arrived, the patient said her throat was feeling worse and swelling, so we went to grab an epinephrine pen. EMT's arrived right as the dose was about to be administered, so we stopped to let them take over.
47 2021-03-13 migraine, numbness 3/3/21: 8:00PM development of fever (100.4F), chills, headache and slight abdominal pain 10 PM. In a... Read more
3/3/21: 8:00PM development of fever (100.4F), chills, headache and slight abdominal pain 10 PM. In addition to listed symptoms numbness in feet develops and abdominal pain worsens; treatment with acetaminophen 11:30 PM. Fever of 100.8F; severe URQ/ULQ abdominal pain; moderate chest pain; treatment with oxycodone. Also joint pain in shoulders and wrists (clears after a few hours) 3/4/21: 1 AM. Chest pain and abdominal pain and numbness in feet persist, while dizziness and migraine develop; treatment with 2.5 mg Zolmitriptan 6 AM. Moderate abdominal pain. Treatment with oxycodone 7:30 AM extreme dizziness develops rendering me unable to walk or stand 8:30 AM: temperature 99.8F rest of day: abdominal pain persists
47 2021-03-14 weakness, unresponsive to stimuli PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first sh... Read more
PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first shot, she complained of body soreness, weakness and headaches that did not go away until she had the stroke on 03/12/2021". Patient is now hospitalized and unresponsive.
47 2021-03-15 migraine Severe injection site pain; fever of 101.5 for 24 hours; severe chills; body aches; migraine; This i... Read more
Severe injection site pain; fever of 101.5 for 24 hours; severe chills; body aches; migraine; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 11Feb2021 at 14:00 (at the age of 47 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date for COVID-19 IMMUNIZATION. Relevant medical history included Epstein Barr. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included "Fiornel" and ibuprofen (ADVIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced severe injection site pain, fever of 101.5 for 24 hours, severe chills, body aches and migraine. The patient received treatment for these events which included ibuprofen (ADVIL), acetaminophen, (TYLENOL) and "fiornel". The outcome of the events severe injection site pain, fever of 101.5 for 24 hours, severe chills, body aches and migraine was unknown. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
47 2021-03-15 tingling Noticeable swelling of face and neck about 20-25 min or so after vaccine . No breathing issues but f... Read more
Noticeable swelling of face and neck about 20-25 min or so after vaccine . No breathing issues but felt face tingling similar to hyperventilating. ER visit identified normal o2 and provided allergic reaction treatment of benadryl pills and prednisone injection right arm.
47 2021-03-15 tenderness Today is the 8th day after 1st vaccination and I have swelling about the size of a quarter, heat and... Read more
Today is the 8th day after 1st vaccination and I have swelling about the size of a quarter, heat and itching at the vaccine site on my left arm. I also noticed earlier this morning around 6:45am that I had tenderness in the underneath [armpit] area of that same arm.
47 2021-03-16 burning sensation Swelling red blotches burning feeling wierd shape tierd
47 2021-03-16 numbness, night sweats I got shot in left arm and entire left side of my body reacted. One the day of the shot, I got muscl... Read more
I got shot in left arm and entire left side of my body reacted. One the day of the shot, I got muscle aches in my left leg and my left arm and leg felt heavy. During the night, I got extreme night sweats but ONLY on the left side of my body. Right side was dry. The next day I got a headache on the left side of my head only, the left side of my face was hot and right side was cool, aches in my left leg arm, neck, and shoulder. Then my left side of my face became numb and swollen. The numbness on the left side of my face got a little better every day but lasted for a week and even 2 weeks later it feels a bit tighter than the right side. I am supposed to get the 2nd shot in a week, and I do not believe I should but really need to talk to someone about this. No one is returning my messages and I have emailed VAERS.. please help.
47 2021-03-16 tingling, pain in extremity, numbness, burning sensation This is a follow up report starting from day after that first report was made -Report # 244159 - Sta... Read more
This is a follow up report starting from day after that first report was made -Report # 244159 - Starting with the 17th of January - I was still having facial numbness/tingling/pressure in my head/feeling like head was going to swell; arms were so heavy - couldn't lift my arms - like a heavy pressure on my chest; breathing was a problem; Swelling in my head caused eye issues. 18th - tingling started on back of neck; affecting my hearing and eyes (swelling in head); a lot of cognitive challenges. 1-20-2021 - heart racing; itchy all over; blood pressure spikes. Heart can feel like it's too fast and then going too slow. 1-21-2021 - legs burning from waist to hip; chest pain; heart racing; struggling to breath. 1/22 - chest pain and discomfort - pain shooting through arms; didn't sleep well. Arms wanted to pull into my chest. Stomach cramping on 1/23 - stabbing pain in wrists and hands; left side on heart pain. Pain was like having a beating. Left knee pain - January 24 - up all night with shooting pain in arm; fine motor pain skills shot - can't do what I need to do. January 25 - Elevated heart rate; elevated blood pressure. 1/26 - vision challenges; fuzzy. Heart racing; feet swollen; face feels puffy doesn't look puffy - pressure/tingly feeling in left cheek. Ongoing and Changing symptoms every day/week - with no let up. 3/11/ - buckling of legs started. Big thing now is my legs are buckling (happening from the hips) - when I try to get up or walk. I haven't fallen yet but I know it's coming. 3/12/2021 - heavy weight back in the arms. I still don't have the fine motor skills. I still can't drive and don't have control over my body and reflexes enough. Still having Pressure in chest and the face and head swelling - is unbearable and affecting my vision. I will see a neurologist next month. Dr is not sure what to do. Jan 12 - first ER visit. I have specific notes/log on all of my symptoms each day. If anyone wants to call - please call on Mondays or Wednesdays only( or Saturday or Sunday.) Also, Menstrual cycle is wonky. I had a normal period before the vaccine - 12/28-12/31/2020 - but didn't have one in January and I had one in February 10th - but just one day; 3/11/2021 - I had my next one and it was four days long and fourth day was very heavy then all the rest of the days.
47 2021-03-16 tingling, seizure Seizure. Convulsions, lost consciousness, amnesia, high blood pressure, confusion. Numbness of lower... Read more
Seizure. Convulsions, lost consciousness, amnesia, high blood pressure, confusion. Numbness of lower lip, tingling in hands and feet, consistent headache, fatigue, memory problems, and filling out of my body are all still occurring five days later.
47 2021-03-17 feeling hot Felt shaky and a warmth went from my feet to head causing a low grade headache. Shaking was internal... Read more
Felt shaky and a warmth went from my feet to head causing a low grade headache. Shaking was internal but then became external. I felt light headed as if my BP was low. The next day I have a rash on my neck with bumps on the side I received the vaccine. I also have had a headache all day as well.
47 2021-03-17 numbness At 11:30 pm I woke up not being able to move any extremities except for my finger tips. I was fully ... Read more
At 11:30 pm I woke up not being able to move any extremities except for my finger tips. I was fully awake but my body would not follow any brain commands regarding any thoughts about moving any part of my body. I dozed back off to sleep and at 4 am I woke again only this time feeling pain all over my body. This time after heavy concentration my body began to follow thoughts of moving starting from my toes up to my neck. I had bad body aches and headache the next day and took Tylenol for it.
47 2021-03-17 pain in extremity Shoulder pain where shot was administered, arm still, hard to move. Took some Aleve and symptoms ha... Read more
Shoulder pain where shot was administered, arm still, hard to move. Took some Aleve and symptoms have lessened.
47 2021-03-17 pain in extremity Injection site reaction - severe .. painful touse my arm.. lasted almost 24 hours
47 2021-03-17 tingling Tingling on left side of face
47 2021-03-18 pain in extremity Woke up with pain in left leg lower calf on February 26 one week after my second vaccine. Had pain ... Read more
Woke up with pain in left leg lower calf on February 26 one week after my second vaccine. Had pain and throbbing in leg couldn?t sleep with pain so on the evening of March 3rd I went to urgent care . Doctor didn?t think it was blood clot because I had no swelling or redness in my leg but gave me a script for ultrasound. I couldn?t get an appointment until the morning of March 5th . Was diagnosed with a very large blood clot in lower leg going up past my knee. I am now in Eliquis blood thinner for 3 months while they run tests
47 2021-03-18 pain in extremity I had my vaccine shot at 6:50 in the afternoon, went home, felt sore and pain in my right shoulder w... Read more
I had my vaccine shot at 6:50 in the afternoon, went home, felt sore and pain in my right shoulder where I had the shot, sleep, took some advil pm so I can sleep, wake up today to get ready for work,(March 19), I cant move my right hand especially when im trying to lift it, causing too much pain, texted and called my company that i cant come to work because moving my right hand causing too much pain, called my doctor also
47 2021-03-18 pain in extremity upper arm soreness for about 28 hrs; This is a spontaneous report from a contactable consumer (patie... Read more
upper arm soreness for about 28 hrs; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Left Arm on 05Feb2021 (Batch/Lot Number: EL3247) at a single dose for COVID-19 immunization. Patient had no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Feb2021 13:00, the patient experienced upper arm soreness for about 28 hrs. The outcome of event was recovered on 06Feb2021 17:00. Patient did not received any treatment for the event. Follow-up attempts are completed. The information on the batch/lot number has been obtained.
47 2021-03-18 pain in extremity Severe pain and heat radiating down right leg from the lower back down the buttock and front of righ... Read more
Severe pain and heat radiating down right leg from the lower back down the buttock and front of right thigh
47 2021-03-19 flushing, difficulty speaking Chest pain, funny feeling in throat, hoarse voice, headache, flushed
47 2021-03-19 muscle spasms Severe leg cramps in left calf muscle overnight, strong enough to wake me from sleep between 3:00-4:... Read more
Severe leg cramps in left calf muscle overnight, strong enough to wake me from sleep between 3:00-4:00 AM, with lingering pain in that muscle and in hip joints still present at time of reporting approximately 24 hours later. Ongoing treatment with naproxen sodium and regular stretching.
47 2021-03-19 pain in extremity I had both vaccines injected on the left arm. The first one was on Feb 5th. My arm got very sore at ... Read more
I had both vaccines injected on the left arm. The first one was on Feb 5th. My arm got very sore at the site of injection the next day for about 24 hr. I started to notice pulsation on my ears. Then as the days went by, this turned into hyperacusis and I consulted about it on Feb 26th. the day of the second shot.. My physician referred me to an ENT. I saw the ENT on Feb 29 and had a hearing test the same day, they found no signs of hearing loss or abnormal conditions. I was diagnosed with pulsation tinnitus and hyperacusis. After the second dose, I had a skin reaction. I had redness at the site of the injection and developed a blister the same day. Then, two days later I noticed a swollen lymph node on the left side of the neck. My arm was very sore from the injection again. I noticed that the joints on my right arm are in acute pain.
47 2021-03-19 tingling She had tingling fingers and palm without swelling. The tingling did not travel up or down her arm. ... Read more
She had tingling fingers and palm without swelling. The tingling did not travel up or down her arm. She had not eaten that day and she said she had just finished cleaning her sister's salon where she was hand scrubbing the floor. She had no other complaints. She said that this started about 5 minutes after the injection and upon follow up in the afternoon she said the tingling had resolved.
47 2021-03-19 tremor Symptoms began with headache immediately after received shot. A few hours after, experienced fatigue... Read more
Symptoms began with headache immediately after received shot. A few hours after, experienced fatigue and fogginess. The next day headache, fatigue, fogginess was worse. That night noticed slight muscle tremors, especially in legs. Also, woke up with night sweats. Although headache, fatigue and fogginess seemed to lessen significantly by day 4, muscle tremors increasing, especially at night. Also, night sweats remained. On day 6, muscle tremors worse.
47 2021-03-21 weakness The next day, I had a fever, chills, nausea, fatigue, dizziness, off balance and just not myself. It... Read more
The next day, I had a fever, chills, nausea, fatigue, dizziness, off balance and just not myself. It got worse during the day, so I had to leave work. I was out work for two days. It continued to get worse and I was starting to get weaker. I just got a lot of rest and took Advil. Consulted doctor by phone.
47 2021-03-21 weakness By that evening, I started experiencing severe chills, headaches and I was very weak. I took Tylenol... Read more
By that evening, I started experiencing severe chills, headaches and I was very weak. I took Tylenol. I tried to go to work the next day, but I could barely move my feet. Then, the diarrhea started to where I was having very watery stool about 10-15 times a day. I couldn't eat anything. I had never been that sick in my life. I was in the bathroom every few minutes. On Saturday, I went to urgent care to get rehydrated since I had lost so much fluids. I was given meds to stop my stomach cramping along with another prescription, but I still couldn't eat at that point. For the next week, I was still extremely sick. I ended up losing 10lbs. I have to see my doctor tomorrow to be evaluated for surgery since this has caused issues with my hemorrhoids. I still experience diarrhea occasionally, so I have to be really careful what I eat. I don't have much of an appetite, so I eat very light.
47 2021-03-21 pain in extremity Patient states she is having soreness to her injection site and soreness up her arm, neck and into h... Read more
Patient states she is having soreness to her injection site and soreness up her arm, neck and into her left jaw.
47 2021-03-22 weakness, pain in extremity Weakness, body aches, joint pain, left arm in pain, intermittent pain in right thigh
47 2021-03-22 feeling hot, difficulty speaking Upon leaving vaccination site I realized my face, neck, chest & lips were red, hot, & itchy. I imme... Read more
Upon leaving vaccination site I realized my face, neck, chest & lips were red, hot, & itchy. I immediately went to the emergency room. The staff took my blood pressure 177/111, they administered Benadryl, Pepcid, & Prednisone. I got to the ER around 6:45 pm and left after observation around 11pm. I was sent home with prescriptions for Prednisone, Epi pen, Pepcid and was told to buy OTC Benadryl to take for the next few days. The next day the redness & hives were not as bad, later that night I felt that I had hives around my lips again. I also had a hoarse/scratchy throat. Spoke to Primary Physician the next day (Saturday) she said to follow the course of action from the hospital & that I could receive the 2nd dose of the vaccine however the ER Dr's said I should not.
47 2021-03-22 pain in extremity PER PT, they have a bruised muscle due to the covid19 vaccine. they've visited the dr numerous times... Read more
PER PT, they have a bruised muscle due to the covid19 vaccine. they've visited the dr numerous times and the md has confirmed that it is bruised. ever since the shot, pt cannot lift or move arm like before and is in pain.
47 2021-03-22 pain in extremity sore arm the evening after the shot but gone in 24 hours. About 4 days later malaise, headache, swo... Read more
sore arm the evening after the shot but gone in 24 hours. About 4 days later malaise, headache, swollen lymph note on right side (shot on the left) so tired, no appetite
47 2021-03-22 tingling, migraine, pain in extremity 10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as... Read more
10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as the day/night went on. Eventually, painful to lift. 12:30pm: Nauseous and not feeling well. Headache increasing. 7pm Migraine, chills, feeling awful, tired, muscle & joint pains, body aches, fever, left arm super painful. Slept restlessly Friday: Slept all day restlessly, chills, fever high of 102, tired, migraine, muscle & joint pain, no appetite. Sat: Migraine, some chills, muscle, joint, arm pain. Sun: Feeling much better, joint pains, arm sore, headache. Sun PM: Red, swelling, tingling on face around chin and mouth. - right side of face Mon: Rash on neck - right side of face Tues: Rash on torso
47 2021-03-23 weakness Weakness, chill, head ache, sore throat,
47 2021-03-23 feeling cold I had a super soar arm and was tired, I also had a headache. I had a lot of muscular pain in my uppe... Read more
I had a super soar arm and was tired, I also had a headache. I had a lot of muscular pain in my upper back . I was feeling off and this lasted for about three weeks, until I got my second dose. I ran a fever with the second dose and couldn't warm, lasted 24 hours. I have been doing better and feeling back to myself.
47 2021-03-23 feeling hot After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe ... Read more
After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe 30seconds and immediately after that I had feeling of sinking as if l am going to die for 30 seconds and I was alright after.
47 2021-03-23 speech disorder became foggy, forgetful, lose thought, couldn't articulate thoughts
47 2021-03-24 weakness Dizziness, anxiousness, nervousness, generalized weakness. Patient given a bottle of water, seated, ... Read more
Dizziness, anxiousness, nervousness, generalized weakness. Patient given a bottle of water, seated, encouraged to relax, calm down.
47 2021-03-24 burning sensation Tongue swelling with sores, burning sensation
47 2021-03-24 flushing, tingling Full body flushing, mild tingling on face, mild hives on neck Duration ~12 hours 50mg Benadryl at on... Read more
Full body flushing, mild tingling on face, mild hives on neck Duration ~12 hours 50mg Benadryl at onset 25mg Benadryl at 4 and 8 hours after onset 650mg Tylenol at 4 and 8 hours after onset
47 2021-03-24 pain in extremity Since the time of receiving the vaccine I have had the following: Almost three days of extreme pain ... Read more
Since the time of receiving the vaccine I have had the following: Almost three days of extreme pain in my arm. I was not able to sleep the first two nights, because I was in so much pain. Shortly after, I had symptoms resembling that of the flu to include body aches, chills, headache, nausea and vomiting. I have had a headache everyday since receiving the shot. I have been nauseous since receiving the shot.
47 2021-03-24 tingling first developed tingling in both hands, then developed numbness and tingling in lips, then palate, t... Read more
first developed tingling in both hands, then developed numbness and tingling in lips, then palate, then throat. She was given water, and while she could swallow, the water felt thick and her swallow felt off/weird. she was given IV benadryl and taken to the ER. There she was given steroids and H2 blockers. She felt her symptoms resolve about 20 minutes later.
47 2021-03-25 feeling hot, tingling 15 min after shot (235pm 3/24) strong tingling in left calf and foot. Continues through today with l... Read more
15 min after shot (235pm 3/24) strong tingling in left calf and foot. Continues through today with lighter tingling however now left foot and toes are extremely cold.
47 2021-03-25 feeling of insects crawling on skin About 25-30 minutes after my shot I had a histamine type reaction... itchy all over, creepy crawly f... Read more
About 25-30 minutes after my shot I had a histamine type reaction... itchy all over, creepy crawly feeling going up my scalp, hives. I took half a Xyzal which helped. About 3 hours later the feeling returned and I took another half of a Xyzal.
47 2021-03-26 inability to speak 12:35pm - patient self administered Epi pen into her thigh - alerted EMS and MD on site, she was mov... Read more
12:35pm - patient self administered Epi pen into her thigh - alerted EMS and MD on site, she was moved to a private location and EMS began assessment. aprox 12:40pm EMS called for transport to a medical facility - the patient experienced vomiting, neck swelling, facial swelling and inability to speak - IV access was obtained by EMS and Benadryl was given IV - she was then given another IM injection of Epi by the EMS team she agreed to transport and was then transported to the hospital around 1:30pm
47 2021-03-26 burning sensation Left pain burning in breast.
47 2021-03-26 tingling After adminstaration of medication, patient had palpitations, shortness of breath, and tingling in t... Read more
After adminstaration of medication, patient had palpitations, shortness of breath, and tingling in the fingers. Paramedic came and took vitals signs and ekg. Patient symptoms subsided and she spoke to a behavioral health. As her smptoms dessipate she was release by the nurse.
47 2021-03-27 numbness, tingling Tingling in face, face numb, metal smell, metal taste in back of throat
47 2021-03-27 tingling 3/28/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ... Read more
3/28/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness, and tingling down left arm. Assessment : Time of assessment . Alert and oriented.complains of dizziness, and tingling down left arm. Actions taken: Water given and drinking, VS at 0840 BP- 149/82, P- 82, O2- 100% Medications administered: Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 0841. Administered by RN. Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/28/2021 8:25 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8733
47 2021-03-28 weakness, nerve injury Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular ner... Read more
Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular nerve injury and weakness; This is a spontaneous report received from a contactable physician (who is also the patient). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 12Jan2021 13:30, as single dose, for COVID-19 immunisation. There was no medical history. The patient did not have COVID-19 prior to vaccination and has not tested for COVID-19 post vaccination. The patient had no known allergies and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 12Feb2021, the patient experienced brachial neuritis w/ suprascapular nerve injury and weakness. The events required physician's office visit and resulted to disability or permanent damage. Treatment for the events included physical therapy. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
47 2021-03-28 flushing flush face, ears red and hot to the touch, scratchy throat, red rash in both armpits, eczema flared ... Read more
flush face, ears red and hot to the touch, scratchy throat, red rash in both armpits, eczema flared over the next few days on right hand.
47 2021-03-28 pain in extremity, sciatica, tremor Minutes after injection, I developed pressure and pain in my ears followed by ringing. I was observe... Read more
Minutes after injection, I developed pressure and pain in my ears followed by ringing. I was observed for 30 minutes due to my prior anaphylactic reaction to a wasp sting. 40 minutes after injection, 10 minutes after leaving the pharmacy, I developed a welt-sized hive on my left foot. It was gone by the time I returned home. I then had hives on my left forearm. They went away with out treatment. At thas point, I had itching and swelling of the thumb on my left hand. That was somewhat painful. That was also the location of my wasp sting in July 2020. That also disappeared without any treatment from my of oinment or benadryl. I then found hives on my waist and stomach while lastly experiencing swelling on my lip. Again, this was all methodical almost over the course of 5-6 hours after injection. One hive would go away to have hives appear in another location. At 9pm that evening, I experienced sudden lower back pain on the right side and had difficulty walking due to the pain resulting from weight being placed on that side. My research suggested it was sciatica. I have no history of sciatica other than some discomfort during my pregnancies, the last of which was nine years ago. I treated this with 8oomg of ibuprofen and went to bed. Several hours later, I was awoken by the right leg shaking in my sleep. It was like a significant tremor. It stopped within a few minutes of me waking up. I was able to go back to sleep. However, I continued to experience sciatic pain on Sunday, March 28th and a bit today, March 29th. It has dissipated significantly and I am not functional. There was no repetition of the leg tremor after the initial and sole incident. I continued to have sporadic hives on my upper body on Sunday, March 28th. There are none present today, March 29th.
47 2021-03-28 seizure Headache; Seizure
47 2021-03-28 tremor Vomiting, Shaking violently, muscle contractions throughout body, joint pain, headache
47 2021-03-29 migraine Headache/migraine, body ache. Took tylenol
47 2021-03-30 facial paralysis Oral swelling , itching ,right side facial drooping. Taken to ER by staff in wheelchair
47 2021-03-30 hot flush Bad Hot Flash when first getting the vx also was sweating, Now I have hot flashes every night I have... Read more
Bad Hot Flash when first getting the vx also was sweating, Now I have hot flashes every night I have to change my pajamas during the night. I also have Brain Fog. It has not gotten better. Did NOT have this issue until after the Covid vx. FYI, I had a hysterectomy when I was 32yrs old.
47 2021-03-30 numbness it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria... Read more
it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria); it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); This was characterized by severe abdominal pain; headache; extreme dizziness; chest pain; brain fog; numbness in feet; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received bnt162b2, via an unspecified route of administration, in left arm on 03Mar2021 09:00 (second dose, Batch/Lot Number: EN6203), via an unspecified route of administration in left arm on 09Feb2021 12:45 (first dose, Lot number: EC(L?)8982) both as single dose for covid-19 immunization. Medical history included acute intermittent porphyria, migraine, hypertension (HTN), dermatitis contact (Known allergies: adhesives (contact dermatitis)), COVID-19 (If COVID prior vaccination: Yes) all from unknown date and unknown if ongoing. Concomitant medications included givosiran sodium (GIVLAARI); lisinopril; hemin (PANHEMATIN DRY); zolmitriptan taken for an unspecified indication, start and stop date were not reported. The patient experienced after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain), it triggered an exacerbation (attack) of her underlying genetic disease (acute intermittent porphyria), this was characterized by severe abdominal pain, headache, extreme dizziness, chest pain, brain fog, numbness in feet all on 03Mar2021 20:00. After each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain) and it triggered an exacerbation (attack) of her underlying genetic disease (acute intermittent porphyria). This was characterized by severe abdominal pain, headache, extreme dizziness, chest pain, brain fog, numbness in feet. She received treatment for the attack and symptoms resolved after several days. The treatment included: Intravenous treatment with hemin (PANHEMATIN). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was resolved. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID tested post vaccination.
47 2021-03-30 migraine Migraine, fatigue, caused Epstein Barr virus
47 2021-03-30 pain in extremity swelling and pain to the left arm; swelling and pain to the left arm; throat closing; This is a spon... Read more
swelling and pain to the left arm; swelling and pain to the left arm; throat closing; This is a spontaneous report from a contactable Physician. This 47-year-old female Physician reported for herself that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration from 27Jan2021 to 27Jan2021 at single dose, dose number; 2 on left arm for covid-19 immunization. Patient was 47 years old and not pregnant at the time of vaccination. Patient's medical history included covid-19 from an unknown date in Apr2020 to an unknown date (if covid prior vaccination: Yes), known allergies to aspirin and lactose intolerant (dates unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number; unknown; reason; not available/provided to reporter at the time of report completion. via an intramuscular route from 06Jan2021 at 12:00 pm to 06Jan2021 at 12:00 pm at single dose, dose number; 1 on left arm for Covid-19 immunization. Facility type vaccine was reported as hospital. Patient was tested for covid post vaccination. Relevant test included nasal swab (covid test type post vaccination); rapid test (covid test name post vaccination) on 08Jan2021 which resulted as negative. Concomitant medication (if other vaccine in four weeks, other medications in two weeks) was reported as none. On 10Jan2021 at 10:00 pm patient experienced left axilla swelling and tenderness 4 days after the first injection with pain at the injection site with the outcome of recovering. She stated that ‘'scared I might have had breast cancer at the time, as there is family hx of cancer''. On an unknown date in Jan2021 she experienced repeat swelling and pain to the left arm which occurred less than 1 day after the second injection. She was concerned of the hot flashes and disturbed sleep consistent to the time when she was infected with covid back in Apr2020. She also experienced slight feeling of throat closing both times with the injections, with the first injection occurred 3-4 days afterwards with no SOB (shortness of breath) and with the second injection it occurred the within 24 hrs. No treatment for adverse event was given. The outcome of events was unknown.
47 2021-03-30 pain in extremity Very sore arm; Very tired; This is a spontaneous report from a contactable consumer (patient). A 47-... Read more
Very sore arm; Very tired; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 27Jan2021 at 08:00 (at the age of 47-years-old) as a single dose for covid-19 immunisation. The patient had no allergies to medications, food, or other products and other medical history was none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received allergy medicine within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, at 17:00 pm the patient had very sore arm and very, very tired. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Jan2021.
47 2021-03-30 pain in extremity Arm hurt; Little tired today/Exhaustion; Chills; Legs look swollen; Itching everywhere; Tested posit... Read more
Arm hurt; Little tired today/Exhaustion; Chills; Legs look swollen; Itching everywhere; Tested positive for Covid/can't stop coughing/ like the whole kind of flu symptoms, body aches, arm hurt; Tested positive for Covid; Hives all over body and tested for Covid 2 days later; This is a spontaneous report from a contactable consumer. The consumer (patient) reported that the 47-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer), via an unspecified route of administration, administered in Arm Left on 05Mar2021 15:15 at single dose for covid-19 immunisation. Medical history was none. Allergies to medications, food, or other products was nope. Concomitant medications were not reported. The patient previously took dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer), via an unspecified route of administration, administered in Arm Left on 12Feb2021 15:15 at single dose for covid-19 immunization. The patient experienced tested positive for covid on 07Mar2021 with outcome of unknown, hives all over body and tested for covid 2 days later on 06Mar2021 06:00 AM with outcome of recovering, can't stop coughing on an unspecified date with outcome of unknown, like the whole kind of flu symptoms on an unspecified date with outcome of unknown, body aches on an unspecified date with outcome of unknown, arm hurt on an unspecified date with outcome of unknown, little tired today/exhaustion on an unspecified date with outcome of recovering, chills on an unspecified date with outcome of unknown, legs look swollen on an unspecified date with outcome of unknown, itching everywhere on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Mar2021. She is not pregnant. She is not pregnant at the time of vaccination. No covid prior vaccination. Covid tested post vaccination included Nasal Swab, Pcr, on 07Mar2021with result of Positive. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was none. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 and test name was Pcr. The clinical course was reported as follows: Consumer stated, The other day, on Friday, I got my second dose of the Pfizer COVID-19 vaccine. And of course that's why I have like horrible symptoms, but since then I am covered in hives and it's really itchy. When paraphrased the concern, consumer stated, And then I just have a question, what happened was, we found out the same day, my son tested positive for COVID when I got the shot. And then like within 4 hours later of the shot, I can't stop coughing either. Means yesterday, I had like the whole kind of flu symptoms, body aches, arm hurt, you know, which are definitely going away. Little tired today but I still have the cough more in the throat and I am covered in hives. Consumer further stated, My husband and my other son were tested, they are negative. I am supposed to go today. Like I do not know what to do and I do not know what's going on but I am itching everywhere. Yesterday, I had like kind of the symptoms they said like body aches, like flu like symptoms, chills. I did not have a fever, just exhaustion and I did have hives yesterday but today I feel like my legs look swollen. I am itching everywhere and they are not away and I still have a 'cough like in ear through my throat' (not clarified). So, do you think should I still get tested today? Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. Consumer stated, What should I do as I got the rash and everything. I would rather, I just need to get tested for the rash and the 'cough' (not clarified). Consumer stated, And they are going to give me information on these hives and everything? Inofrmation regarding lot/batch number has been requested.
47 2021-03-31 difficulty speaking Within about 5 minutes, I started to feel dizzy, have sinus pressure building, and sensation of my t... Read more
Within about 5 minutes, I started to feel dizzy, have sinus pressure building, and sensation of my throat closing. This was a drive-thru site and they immediately asked you to keep driving to a "holding line of traffic" to monitor for adverse events. During this time, the sinus pressure increased, and I started to have to clear my throat, plus hoarseness. I still have 5 hours later. I told the EMT who allows you to go after 15 minutes, and he told me to drink water, take a benadryl and had me keep driving. I had my boyfriend drive. At 30 min post-admin, began sneezing, coughing, slight shortness of breath, and took benadryl. Most symptoms have resolved.
47 2021-03-31 numbness, facial paralysis, tingling Left cheek got tingly and numb with slight droop about 20 minutes after vaccine. Continue to have sy... Read more
Left cheek got tingly and numb with slight droop about 20 minutes after vaccine. Continue to have symptoms one day later.
47 2021-03-31 numbness 5 minutes after receiving the vaccine my mouth started to feel numb and tingly, then my whole face f... Read more
5 minutes after receiving the vaccine my mouth started to feel numb and tingly, then my whole face felt numb and then I felt it rush through my body. They told me it was histamine being released in my body and that it was normal. The kept me only for the full 15 minutes. I had a dissolvable Zyrtec on me, so I took one 10ml. After about 45 minutes to 1 hr my face felt normal again. Until that time my face felt as if it was puffy and had a numb feeling.
47 2021-03-31 muscle spasms 5:00am chills, cramping, nausea, mild vomiting (no food, empty stomach) 7:00am chills, cramping, na... Read more
5:00am chills, cramping, nausea, mild vomiting (no food, empty stomach) 7:00am chills, cramping, nausea, mild vomiting, fever 99.9 taken at 7:30am) Called doctor. Took Omeprazole and two tylenol at 8:00am.
47 2021-03-31 pain in extremity, feeling cold Headache pain in left thigh Chill muscle pain back pain pinching feeling in my chest
47 2021-03-31 pain in extremity, numbness Extreme numbness in my fingers and sharp pain in left foot, brief but intense 2 -3 hours after vacci... Read more
Extreme numbness in my fingers and sharp pain in left foot, brief but intense 2 -3 hours after vaccination. Then, the next day my right leg, unbeknownst to me fell asleep-.When I stood up from my chair, my ankle rolled underneath my body and I collapsed. The pain was so intense that I almost vomited. I have severely injured my ankle and am intense pain. Typically when a foot falls asleep, you feel it. But my body didn't tell me it was "asleep," causing me to immediately collapse. I just don't see how this was a coincidence considering all of the numbness and pain I had in my limbs a few hours after the vaccine.
47 2021-03-31 pain in extremity Pain in arm, low grade fever, chills, body aches. Stomach issues
47 2021-03-31 tingling PATIENT REPORTED TINGLING SENSETION ON TIP OF THE TONGEU AND ARM , , NO PROBLEM BREATHING. PT BP WA... Read more
PATIENT REPORTED TINGLING SENSETION ON TIP OF THE TONGEU AND ARM , , NO PROBLEM BREATHING. PT BP WAS CHECKED 3 TIMES, NORMAL, TONGUE NUMBNING GOT WORSE AFTER 15 MIN , WE GAVE 50 MG BENADRYL, BP STILL OK AFTER 20 MINUTES PT REPORTED NUMBNESS GONE REFUSED 911 HAD NO PROBLEM BREATHING , PT ADVISED TO CALL MD TOO
47 2021-04-01 flushing Facial flushing and redness , also redness noted on chest. v/s 136/84, 82, 100% RA, Alert and orient... Read more
Facial flushing and redness , also redness noted on chest. v/s 136/84, 82, 100% RA, Alert and oriented x4, patient observed for 30 minutes with resolution of redness to chest and face. patient refused transport.
47 2021-04-01 flushing Patient received the covid-19 vaccine, about 5 minutes after the patient starting having blurred vis... Read more
Patient received the covid-19 vaccine, about 5 minutes after the patient starting having blurred vision, at this point the pharmacy staff was alerted and the emergency kit was taken to the patient. The patient then started flushing and began swelling. Patient's vitals were normal but she continued to swell showing significant signs of allergic reaction. Patient was transported by ambulance to Hospital ER
47 2021-04-01 numbness, pain in extremity pt started to feel funny, numbness in the jaw, arm pain, leg pain
47 2021-04-01 migraine Abrupt cascade of symptoms at 11:15pm after 3pm injection: Muscle soreness, sudden migraine (no war... Read more
Abrupt cascade of symptoms at 11:15pm after 3pm injection: Muscle soreness, sudden migraine (no warning, unlike most migraines), fever 100.5 degrees F, lethargy. Migraine addressed partially successfully with Treximet 2x. Tylenol 1x for ache. All others gone within one day. Quite abrupt declination of symptoms as well.
47 2021-04-01 migraine Chills, Migraine, fever for 2 days ( 102.8).
47 2021-04-01 pain in extremity Extreme Somnolence, fatigue, arm pain, joint pain, chills X 3d days
47 2021-04-01 tingling, feeling hot Started 1 minute after vaccination. Started with nausea and chest pain and tingling in vaccinated ar... Read more
Started 1 minute after vaccination. Started with nausea and chest pain and tingling in vaccinated arm down to hands/fingers. Swelling at injection site. Then started to feel hot/sweaty. Swelling occurred in bilateral arms and fingers and weakness in the legs. No breathing issues but then reported swelling of lips and tongue. Gave 50mg Benadryl. Called EMS with consent
47 2021-04-01 tingling 03/11/2021-4:40pm-Pt called-rec'vd Pfizer vac at 1:15pm, in observation area L arm felt heavy, didn'... Read more
03/11/2021-4:40pm-Pt called-rec'vd Pfizer vac at 1:15pm, in observation area L arm felt heavy, didn't tell anyone, left the clinic, 3 pm, tingling up L arm, collarbone sore, 4pm mouth tingling, tongue numb/swollen, states same reaction w/ shellfish yrs ago, no shellfish since. Pt took fish oil, B12, Magnesium /Calcium citrate supplements for first time this am, instruc Pt to call 911 immediately, Pt called a clinic instead, has epi pen at home, decided to take Benedryl. 5:30pm tongue less swollen, Pt to consult with PCP re 2nd dose. 3/19/21- tongue remained swollen thru day 5/6. PCP told Pt reaction not vaccine related, ok'd to get 2nd dose. Pt plans to consult with son's allergist, will report back to PHN.
47 2021-04-02 burning sensation A mild rash developed on chin Within a week, the rash spread to neck, upper lip, nose, and eyebrows.... Read more
A mild rash developed on chin Within a week, the rash spread to neck, upper lip, nose, and eyebrows. By two weeks, the rash worsened.; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; This is a spontaneous report from a contactable Consumer (patient). A 47-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9264, Expiration date was not reported), via an unspecified route of administration, in right arm on 27Jan2021 15:30 as single dose for covid-19 immunisation. Relevant medical history reported as none. Concomitant medication included metronidazole (FLAGYL), levocetirizine dihydrochloride (XYZAL) and melatonin all are taken for an unspecified indication, start and stop date were not reported. It was reported that a mild rash developed on chin within 48 hours. Within a week, the rash spread to neck, upper lip, nose, and eyebrows. By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day on 29Jan2021 05:00 PM. No changes in diet, facial products, cleaning/detergent products and have been wearing a mask since August with no issues. Patient did not have covid prior vaccination. Patient did not test for covid post vaccination. Patient received the treatment of adverse event was Prescribed Elidel, Montelukast, Allegra, Doxepin. The outcome of the events was not recovered.
47 2021-04-03 numbness Moderate numbing of right side of face and tongue
47 2021-04-03 pain in extremity body aches; Fever 101 degree celcius; CHILLS; sore arm; This is a spontaneous report from received f... Read more
body aches; Fever 101 degree celcius; CHILLS; sore arm; This is a spontaneous report from received from a contactable consumer, the patient. This consumer reported different events after each dose of the same product for the same patient; This is the second of two reports. A 47-year-old adult female received the second dose of intramuscular BNT162b2 (solution for injection; Lot EL3249 expiry 31May2021) as a single dose in the right deltoid on 20Jan2021 at 14:00 (at 47-years-old) for COVID-19 immunisation. There was no medical history or concomitant medications reported. The patient previously received her first dose of intramuscular BNT162b2 (Lot EK5730) on 30Dec2020 (at 46-years-old) and donated blood seventeen days later and showed no antibodies. The patient reported that she received the second dose of vaccine on 20Jan2021 at 14:00 and by 21Jan2021 02:00, reported as within twelve hours, she had a sore arm, 101degree Centigrade fever, and body aches and chills. The patient denied any emergency room visit or physician's office visit and was not admitted to the hospital for the events. Post-vaccination antipyretic use on 20Jan202 included oral acetaminophen (TYLENOL) 1000mg, and oral ibuprofen (MOTRIN) 600mg. Treatment was received for the events. The outcome of the events sore arm, 101degree Centigrade fever, and body aches and chills was recovered on unspecified date(s) in 2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056901 PFIZER (Same patient/product; first dose, different event separated in time)
47 2021-04-03 pain in extremity My arm sore so bad
47 2021-04-03 pain in extremity I woke up with a headache and a sore arm. As the day progressed I started to feel terrible. Very tir... Read more
I woke up with a headache and a sore arm. As the day progressed I started to feel terrible. Very tired and generally just felt yucky.
47 2021-04-03 tremor Chills and shakes for 2 hours Stomach pain- very sharp stabbing pain Headache Arm injection site ver... Read more
Chills and shakes for 2 hours Stomach pain- very sharp stabbing pain Headache Arm injection site very tender
47 2021-04-04 discomfort I have a rash on the injection site as well as under my arm pit. I also felt like I had the flu beca... Read more
I have a rash on the injection site as well as under my arm pit. I also felt like I had the flu because I was sore woke up sore the night of the first shot feeling like I had body aches and couldn?t get comfortable for the rest of the night. I was also very lethargic the next day very tired and nauseous as soon as I got up in the morning and had to go to the restroom because I had diarrhea that morning. I still have soreness and a slight rash on my left arm near the injection site but it is resolving itself and I have not had any issues with aches and pains as I?ve been taking ibuprofen sense the first night but not as I don?t need it as much so things seem to be improving.
47 2021-04-04 feeling hot, tingling, restless legs syndrome, pain in extremity 5/25 Received vaccine at 9:30 a.m. at the hospital. Sore arm developed about 3 hours later. Later th... Read more
5/25 Received vaccine at 9:30 a.m. at the hospital. Sore arm developed about 3 hours later. Later that afternoon, had muscle aches and tiredness. 5/26 10:30 a.m. noticed a couple hives on my upper thigh and inside forearms. Realized they were there before I got to work, but didn't make note of it. 12:00 felt very tired, muscle aches, especially in neck, felt like mild flu. noticed hives/rash getting worse in the afternoon. They were not itchy. 8:00 p.m. Called on call doctor due to worsening rash/hives. "Breathing seemed fine. Dr. called back and advised 10 ml Benedryl along with nightly Zyrtec. Took 10 ml liquid Benedryl. 9:00 p.m. noticed breathing got a little easier, less constricted. Made sure my son's epi pen was available if needed. Saturday, March 27 Had chills in the middle of the night, turned on electric mattress pad to get warm, making hives worse. 4:00 a.m. 10 ml Benedryl. Didn't notice breathing getting better, or not lasting very long. Contemplated ER if got worse. 8:45 a.m. 10 ml Benedryl. Temp is 98.8 10:00 took Zyrtec and ibuprofen Called Dr. in the morning, who suggested medrol dose pack of steroids. Due to past history with hives, requested 10 day course of steroids. 11:00 6 prednisone 1:30 p.m. 10 ml Benedryl possible less internal agitation 5:45 Benedryl 11:00 p.m. Zyrtec, temp 98.2. Hives continued to spread, but at much slower rate. Felt on face, ears and back of head. More prickly sensation form the hives. Some spots so many hives it is just one large red spot. Felt very hot. Tried to use ice pack to cool down and ease tingling irritation from hives. Sunday, March 28 1:10 a.m. Benedryl for restlessness (especially in legs), chamomile tea 4:00 a.m. magnesium, which finally settled the restless legs. 11:30 prednisone Called Dr. back since hives didn't seem to be dissipating, and feeling very agitated internally. We both agreed it was time to go to urgent care. Saw Dr. at Urgent Care. She offered steroid shot, but stated it would further decrease the effectiveness of the COVID vaccine. Observed that my back was looking better from the hives. Opted to try famotidine and hydroxyzine hcl for allergy and agitation. 2:45 took hydroxyzine and famotidine within an hour, started to have relief from the intensity. That night, I was finally able to rest and sleep. Over the next few days, the hives continued to go away, and I wasn't bothered internally by them again.
47 2021-04-04 hot flush Pt. stated "I felt a hot flash and lightheaded 10 minutes after getting vaccinated." "It started on... Read more
Pt. stated "I felt a hot flash and lightheaded 10 minutes after getting vaccinated." "It started on my arms and it wend down to my legs." At 10:25am vital signs taken. BP 130/70, HR 54, O2 Sat 100%, R 16. Pt. stated her HR is usually low. At 10:38am pt. stated light headed is going away and I only feel the hot flash in my legs. At. 10:49am, pt. stated I feel so much better and refused to go to the hospital. At 10:51am pt. went home.
47 2021-04-04 numbness On 04/05/21, the patient came in for her second dose and reported that about 20 minutes after receiv... Read more
On 04/05/21, the patient came in for her second dose and reported that about 20 minutes after receiving her first dose, she began to experience facial numbness on the left side of her face to include the cheek, temporal, and left side of forehead. She states that she never reported the incident until now and did not take any OTC medications, such as Benadryl. She states that facial numbness subsided the same night.
47 2021-04-04 numbness The patient began to experience numbness in her left cheek about two minutes after receiving the sec... Read more
The patient began to experience numbness in her left cheek about two minutes after receiving the second dose today. She was immediately given OTC Diphenhydramine as mentioned previously. She was monitored in the clinic for about 30 minutes, and the numbness never progressed. She did not want to take the full dose (50 milligrams) of OTC Benadryl due to feeling drowsy with Benadryl and needing to return to work. She was instructed to take OTC liquid Benadryl every 4-6 hours as needed and call 911/go to the local emergency room if symptoms progressed. She was accompanied by her co-worker, who had driven them both to the clinic from their place of employment.
47 2021-04-04 muscle spasms severe cramps has not stopped
47 2021-04-05 flushing Tired, thirsty. Flushing/sweating - BP119/68 (pulse 65).
47 2021-04-05 pain in extremity 2nd shot side effects: Headache - within an hour or two Arm pain within an hour or two Fatigue, seve... Read more
2nd shot side effects: Headache - within an hour or two Arm pain within an hour or two Fatigue, severe arm and body pain at around 12 hours continuing through 24 hours low-grade fever around 24-28 hours intense scalp itching and pain around 36 hours (this happened for both 1st and 2nd shot)
47 2021-04-05 pain in extremity Had expected fatigue and chills and bad headache on day two after vaccination. Lasted about 18-20 h... Read more
Had expected fatigue and chills and bad headache on day two after vaccination. Lasted about 18-20 hours. Sore arm progressed over a few days to throbbing aching left shoulder. It kept me up at night for days. Shoulder got tighter and achier, peeking at about 2 weeks post vaccination. I continued to use arm normally (I am a swim coach with lots of overhead demonstrations) until I was in acute pain three weeks after vaccine. At which point I sought care. Had X-ray and MRI done. Received oral steroid dose-pack which helped greatly after 3-4 days. I have started PT to return range of motion and address findings on MRI. (Rotator cuff and bicep tendon itis) PT has discovered neck inflammation and loss of motion and is focusing on return of neck motion to start. She is considering if post-vaccine neck nerve compression is actually the root of my pain.
47 2021-04-05 tingling, pain in extremity, nerve pain She got her vaccine, started feeling more and more as the day progressed that her arm was hurting an... Read more
She got her vaccine, started feeling more and more as the day progressed that her arm was hurting and then as the day progressed she felt like her last 2 fingers in her left hand were tingling, and that extends up towards her forearm. This morning they hurt extremely bad, she cannot open a container, and having ulnar nerve pain, cannot do anything as she cannot use the entire hand due to the pain and has weakness in that hand. She is not having any other pain. She has not taken anything for her symptoms.
47 2021-04-05 throat numbness Tingling/numbing in the throat and tongue 4 hours post injection. Took 25mg Benadryl and symptoms di... Read more
Tingling/numbing in the throat and tongue 4 hours post injection. Took 25mg Benadryl and symptoms dissipated within 30 minutes. Symptoms reappeared in 4 hours. Took 25mg Benadryl and symptoms dissipated. Slept through the night, woke the next morning to milder, but similar symptoms (tingling/number throat and tongue). Contacted general practitioner and she advised not to take the second dose.
47 2021-04-07 weakness, cold sweat Several mins after vaccine, patient began to feel weak. felt like she was going to pass out. has hx ... Read more
Several mins after vaccine, patient began to feel weak. felt like she was going to pass out. has hx of tinnitus, ringing in left ear intensified after injection. was diaphoretic and clammy. sat in med obs, drank some water, and felt better. 1630 bp 120/80 hr 82 rr 18 sats 95% on ra. 1647 bp 117/78 hr 82 rr 18 sats 96%. s/s resolving. 1700 escorted to vehicle with no issues.
47 2021-04-07 discomfort At 1025 patient alerted observation nurse LVN to a sensation of itching and difficulty swallowing. P... Read more
At 1025 patient alerted observation nurse LVN to a sensation of itching and difficulty swallowing. Patient requested water. Patient tolerated water well, no shortness of breath, lung sounds clear. Vitals BP 140/91, Pulse 81, Respirations 21, Temp 97.0, SaO2 97%. Patient appears anxious and tearful. 1040 Benadryl 25 mg PO given due to patient stating itchiness and difficulty breathing. 1045 patient stated it was easier to breath and felt comfortable, patient tolerated water well. Vitals 135/92, Pulse 73, Respirations 21, SaO2 98%. Charge Nurse alerted to patient status. Patient visibly comfortably lung sounds clear, mild itchiness to throat that patient stated was improving. Charge Nurse educated patient to the signs and symptoms of an adverse reaction, patient states understanding. Patient drove alone so nurse advised patient to call for family to come pick her up from site and not be alone. Educated to call 911 or go to ER if symptoms return. Patient agreed to wait in observation with LVN while she attempted to call for family. Patient tolerated standing. 1052 Vitals BP 125/117 Pulse 70, SaO2 97%, Resp 20, Temp 97.2. Vitals reassessed at 141/93, pulse 77, Respirations 20, SaO2 98% Temp 97.3. Nurse present with patient at all times. At 1122 patient once again complained of itchiness in her throat and was in visible distress. Charge Nurse alerted. EPI Pen 0.3 mg administered by nurse to Right thigh, 911 called by charge nurse. BP 161/100, HR 91, SaO2 94%, Temp 96.8. Patient stated she felt some relief after Epinephrine administration. 1127 Vitals, BP 165/98 HR, 94, SaO2 97% but patient still stated she felt ?like something is stuck?. 1129 paramedics arrived and attended to patient. 1131 patient was taken in stretcher with belongings.
47 2021-04-07 involuntary muscle movements 1207 - Patient has involuntary movement of R leg (history of functional neurologic disorder). BP = 1... Read more
1207 - Patient has involuntary movement of R leg (history of functional neurologic disorder). BP = 115/76, HR = 85 and O2 Sat = 98%. 1210 - Patient having bilateral foot movement. 1215 - No involuntary movement noted. 1220 - Patient sat on side of bed - no involuntary movement noted, but has slight sense of aura. 1225 - Patient discharged to home with husband - ambulated without difficulty. Advised to discuss with MD and to notify vaccinator of need to lie down for injection. BP = 110/64, HR = 81, RR = 18 and O2 Sat = 98%
47 2021-04-07 pain in extremity Sore arm; chills for a short period of time; hard lump on gum below left bottom tooth; swollen lymph... Read more
Sore arm; chills for a short period of time; hard lump on gum below left bottom tooth; swollen lymph node and sore throat on right side of neck.
47 2021-04-07 tingling, muscle spasms I had a sudden and extreme loss of calcium. My face was tingling and I went into a sever case of te... Read more
I had a sudden and extreme loss of calcium. My face was tingling and I went into a sever case of tetany. I took my forteo and calcium abs waited. It took a good hour or so to get over the attack. It was definitely from the shot and for some reason it messed with my calcium levels. The next day I was very achy fever chills and pain. But that was more normal reaction s. The calcium was very sudden abs s about 5 hours after injection.
47 2021-04-08 nerve pain Itching, swelling, redness, and injection site. Severe nerve pain shooting down all limbs, severe ch... Read more
Itching, swelling, redness, and injection site. Severe nerve pain shooting down all limbs, severe chills, fuzzy brain, all over joint pain, exhaustion
47 2021-04-08 pain in extremity, burning sensation Monday following COVID the vaccination( 2 days later) , patient noted pain in left axilla and for... Read more
Monday following COVID the vaccination( 2 days later) , patient noted pain in left axilla and forearm that felt like a "burning pain"
47 2021-04-08 pain in extremity It gave me strong pain in the Arm, the next day then two days later I developed a very bad flu body ... Read more
It gave me strong pain in the Arm, the next day then two days later I developed a very bad flu body pain congestion and a lot of tiredness passed on Friday I feel a little better I fix myself I put on perfume and I realize that I have no smell then I went to do the rapid test that gave Positive and I wait for the PCR result
47 2021-04-09 discomfort, pain in extremity Rash started on 4/7 and continues to grow. Rash /hives/inflammation all over both arms and left leg... Read more
Rash started on 4/7 and continues to grow. Rash /hives/inflammation all over both arms and left leg. Spreadig to stomach and upper thighs. Painful pinching in uppper left arm, skin tightness, redness, itchy. Very uncomfortable.
47 2021-04-09 migraine Day 2 fatigue & slight dizziness Day 3 severe vertigo/dizziness upon waking especially rolling from... Read more
Day 2 fatigue & slight dizziness Day 3 severe vertigo/dizziness upon waking especially rolling from left side to right to get out of bed. It lasted less than 2 minutes. When I got out of bed, I couldn't walk straight & had to grab wall for balance. Later that day I had a severe migraine. Days 4-8: severe vertigo/dizziness upon moving from left side to right when lying down and sitting up from lying down. Feeling lasts for less than 2 minutes.
47 2021-04-09 muscle spasms, feeling cold, pain in extremity, speech disorder I was given the vaccine in the right upper arm. I picked that arm due to PHN in my left trigininal ... Read more
I was given the vaccine in the right upper arm. I picked that arm due to PHN in my left trigininal nerve from shingles. They gave me the vaccine and I proceeded to move my car to the 30 minute waiting area. I put the car in park and suddenly I felt dizzy. Like I was looking through a magnifying glass backwards. Since I have a reaction to Xolair in 12/15/2021 I had been extra cautious. This hit my quickly. It felt like I had a ton of weight on my chest. It progressed quickly to where I felt like I couldn't breath. The staff was watchful. They called an ambulance. They monitored me there but it was like I could not wake up. I wanted to fall asleep. My blood pressure was higher than normal at one point during my ER visit I looked up and my blood pressure was 137/91. I felt like I had when I had a many stroke in 2019 my speech was slower I couldn't get the words out. My toes and finger were cold. They transported me to the ER for observation. It was that that the head ache only in my right frontal lobe started and my arm and neck on the right side began to hurt. Within about 1.5 hours I began to wake up from the fog and my speak cleared up. While laying on the bed my fingers were curling up. As the speech returned that hands warmed up.and my fingers began to release. The staff at the clinic had given me benadryl within about 20 minutes of the vaccine. Upon release I was droggy and like a huge adrenal rush had worn off. I had slight stuffy nose and like I had a severe hay fever reaction that I was coming down from last night. This hit me quick and hard. The ER said I had a stress reaction and a head ache of unknown cause as all of my blood work came back normal. But honestly at one point I felt paralyzed. Even today I feel stuffier than I normally do. Like I have a slight asthma attack. I know my blood oxygen was 97 % at one point and I can tell when it drops even a precent
47 2021-04-09 pain in extremity About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up a... Read more
About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up as well as my hands. Then My right ankle swelled up. My face and hands had hives on them. My throat felt better, I thought but about 1/2 hr. Later I started wheezing and my right ankle and leg were swollen so, I went to the urgacare. They saw me but told me that I should've gone to the ER. I have a history of anaphylaxis. They gave me steriods and Benadryl via shots and sent me home with the same. I woke the next morning with a sore arm, a horrible headache and my face broke out into hives and was swollen again. Today is the 4th day after and my face still feels a little swollen, I have a headache and now an earache in my left ear. Today I also felt nauseous and couldn't eat.
47 2021-04-09 throat numbness Immediate taste and tickly/tingly feeling in back of throat that left tongue and back of throat feel... Read more
Immediate taste and tickly/tingly feeling in back of throat that left tongue and back of throat feeling a little numb. This all lasted a couple of days. Face and neck were itchy for a couple days. Face became red and splotchy 7 hours later but only lasted 30 min. Felt generally off for a couple days (tired, achy, nauseous, pain at injection site). Itchy rash and pain at injection site started 1 week later and lasted 3-4 days.
47 2021-04-10 pain in extremity Right arm very painful and had a fever. Took Tylenol.
47 2021-04-10 pain in extremity Suddenly onset exhausted and disoriented. 13 hour nap. Frequent wakings with arm pain and panic.
47 2021-04-11 burning sensation Severe reaction began with flu like symptoms and burning face to into head to toe severe body rash
47 2021-04-11 cold sweat The day after the second dose of the vaccine with chills and a low grade fever. I had a cold sweat a... Read more
The day after the second dose of the vaccine with chills and a low grade fever. I had a cold sweat and shortness of breath. It felt like something was restricting my airway. My blood pressure felt like it was elevated. My fever chills and sweats lasted about five days. The blood pressure feeling with anxiety and panic attacks lasted for five weeks. I also had fluid in my lungs. During this time I felt extremely fatigued. I developed a horrible lower back pain about three weeks after the vaccine and I was congested with a horrible sinus headache. I have never had back problems before, I could not sit down, and this lasted for six weeks. It is slightly better now but still present. It was severe for I got some physical therapy. I am currently have a lot of GI issues and I am scheduled with a GI Specialist. I have lower GI pain. I visited the ER 04/02/2021. I am also very congested with headache in the forehead area.
47 2021-04-11 numbness, pain in extremity I was starting my period (light spotting) and it just stopped after the first dose. That was Mar 9, ... Read more
I was starting my period (light spotting) and it just stopped after the first dose. That was Mar 9, 2021. I have not gotten my period since. According to the doctors as well as my menstruation cycles prior there were no signs or peri menopause or menopause. Additional symptoms: After the first dose: (lasted for 3 weeks) Extreme fatigue. (Sleeping 20 hours a day) Swollen joints. (Radiating pain from the occipital ridge downward through out the spine & the right knee). Constant pain in my neck, shoulders, hips. Brain fog. Blurry vision/vision changes and things looked like they were vibrating/jumping Numbness in my face Tasted metal in my mouth Nausea Diarrhea Loss of appetite Depression After the second dose (lasted 10 days) Entire left arm was in pain Swollen and stiff from left arm, base of my occipital ridge/top of spinal column , neck shoulders, all the muscles between my shoulder blades the day after. Starting on day 3, all the areas up and down my spinal column felt swollen, stiff and in pain. Dissipated after 10 days. I lost mobility in my hip joints. Swollen right knee ( I am still experiencing these 2 symptoms, 4/12/21). Fatigue Brain fog. Diarrhea. Nausea Loss of appetite
47 2021-04-11 migraine Horrible Migraine that has not responded to treatment
47 2021-04-11 cold extremities About 15 minutes after vaccine, noted L arm "stiffness" at site, wrist with some numbness/tingling a... Read more
About 15 minutes after vaccine, noted L arm "stiffness" at site, wrist with some numbness/tingling at 4 and 5th digits and wrist. As time progressed, felt "cold" in hand as well. Denied shortness of breath, swelling, no issues swallowing. VSS: BP 110/68, pulse 69, p ox 100%; remained stable throughout staying another 20 min. Numbness/tingling resolved; some stiffness/coldness remained/ No issues breathing. Felt better; comfortable leaving. Reviewed if symptoms worsen seek medical attention. If issue remains, follow up with MD.
47 2021-04-12 breast pain Intense pain, swelling and hardening of left breast. It started on Tuesday 4/6 and was almost comple... Read more
Intense pain, swelling and hardening of left breast. It started on Tuesday 4/6 and was almost completely resolved by Saturday 4/ 10
47 2021-04-12 cold sweat I started vomiting 12 hours from when I received the shot. Hot and cold sweats. Stomach cramping. As... Read more
I started vomiting 12 hours from when I received the shot. Hot and cold sweats. Stomach cramping. As the next few days went on, I was feeling foggy, unmotivated and extremely depressed.
47 2021-04-12 slurring It wouldn't let me add this, but it was my first Pfizer shot. I started feeling dizzy within the fir... Read more
It wouldn't let me add this, but it was my first Pfizer shot. I started feeling dizzy within the first 30 minutes, and didn't think much of it. Went home and just under 3 hours later, started to feel strange. I felt almost drunk, like my brain was fuzzy. Even more dizzy. Then my tongue swelled. I then had palpitations and felt my heart jump. The palpitations came and went a few times through the night. I couldn't sleep and experienced some slurring. I then took aspirin and tried to drink a lot of water. I felt scared so asked my parents to call every hour to make sure i was alive. I didn't think to call 911 because I felt so out of it. I had a mild headache that went from my forehead to the back, but it felt more strange than anytthing. The next morning my tongue had several bites all along the edges and top of the edges. I then got hives on my face, on Sunday, April 11. I took benadryl and put cortizone cream on. I took benadryl again on 4/12. I'm still dizzy and slightly short of breath. i have an appointment with an immunologist for thursday.
47 2021-04-12 numbness She reported both the arms are numb
47 2021-04-12 pain in extremity, breast pain About 30 minutes after vaccine, strong headache on left forehead, left arm and hand felt funny (tig... Read more
About 30 minutes after vaccine, strong headache on left forehead, left arm and hand felt funny (tight, strange sensation), left shoulder and neck was tight/sore/aching, and left cheek/face felt tight - strange sensation, left jaw was tight and joint was popping (happens when I get dental fillings). I could feel a tight strange sensation on the left side only - could tell it was not crossing my midline, no strange sensation on my right side at all. I still had feeling and movement on the left side but, felt really weird and tight- similar to the feeling after a dental filling anesthesia is wearing off. Weird sensation wore off by evening. Arm was sore for 3 days. 9 days after vaccine outer areas of breast were very sore and at 10 days felt a lump under right armpit. Developed hives on both forearms 12 days after vaccine. Had headaches on and off for one week. Had fatigue for about 4 days.
47 2021-04-12 pain in extremity Day 1, 3/29: got the 1st dose of Pfizer Covid vaccine (left arm) Day 2-- Day 8: 3/30-- 4/5: Couldn... Read more
Day 1, 3/29: got the 1st dose of Pfizer Covid vaccine (left arm) Day 2-- Day 8: 3/30-- 4/5: Couldn't lift my left arm (where the vaccine was given) for the whole day of 3/30. Felt pain/sore of my left arm, but gradually got better and better. Day 5: 4/2: noticed a penny size bruise on my left index finger, close to my palm. No pain and I didn't find any other bruise in my body. The bruise lasted for 4-5 days.
47 2021-04-12 tingling, numbness, pain in extremity Woke next morning with swollen eyelids, pink skin, itchy/tingling sensation on left side of face, pa... Read more
Woke next morning with swollen eyelids, pink skin, itchy/tingling sensation on left side of face, pain left arm/ache, pinching sensation in left side/middle of neck, fatigue. Eye swelling gone by end of day after taking shot. Have had continued lowered blood pressure, low pulse pressure, increased blood pooling in hands and feet, left leg pain (no swelling) behind the calf and upper inner thigh, left arm numbness that comes and goes particularly at inside wrist and top of shoulder front near armpit since the shot.
47 2021-04-12 tingling, numbness Wednesday Night I started feeling slightly dizzy with a seeming loss of equilibrium. When I woke T... Read more
Wednesday Night I started feeling slightly dizzy with a seeming loss of equilibrium. When I woke Thursday morning I felt a slight numbness and tingling in the left side of my face. My left ear felt "full" After my second dose on Saturday, April 3, at 8:35 a.m., Starting Wednesday, April 7 around 7:00 p.m., I experienced a slightly more serious facial tingling and numbness, including tongue on the left side. This feeling was continuous for several days and is currently coming and going. Tingling and numbness continues and my ear still feels full today, April 13
47 2021-04-12 tingling, cold extremities Short of breath, cold tingle in fingers, CP
47 2021-04-12 seizure Body aches, fainted followed by a Seizure
47 2021-04-13 feeling cold Feels very cold and restless with no fever. She is currently in bed and we are waiting to see if if ... Read more
Feels very cold and restless with no fever. She is currently in bed and we are waiting to see if if passes soon. She didn't sleep well and now is very restless and on the verge of tears.
47 2021-04-13 feeling hot hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat wa... Read more
hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat was starting to swell. Used Epi pen #1 . I did not get better. I felt even more on fire and my skin was hot to the touch. My tongue was really swollen and things get super fuzzy after the I might die feeling. Epi#2 Given around 5 minutes after Epipen 1. Medics took me to the ER and more rescue meds were given. I was admitted to the nuero trauma floor for 24 hrs and given meds and iv fluids. I got out the next afternoon. By the next day I was back in urgent care. They gave me meds and sent me home. By 9pm that night I was using epi#3 and going back to the ambulance. I have been to urgent care 2 times since for continued issues. I have zero appetite and my whole GI system hates me. I am alive and breathing but still feeling the impact of all of this.
47 2021-04-13 numbness 1135 RNs responded to vehicle 2 to c/o dizziness, numbness in hands, swelling nasal passages. Pt ale... Read more
1135 RNs responded to vehicle 2 to c/o dizziness, numbness in hands, swelling nasal passages. Pt alert, oriented, denies SOB. Benadryl 25mg PO ADMINISTERED PER 50 Driver moved car to front of lot. Pt reported further dizziness, headache, tongue becoming thick. 1145 RN contacted Dr. instructions to give another 25mg Benadryl PO
47 2021-04-13 pain in extremity Arm pain started about 12 hours after shot Fever, aches, chills, headache started 15 hours after sho... Read more
Arm pain started about 12 hours after shot Fever, aches, chills, headache started 15 hours after shot and lasted 24 hours
47 2021-04-13 pain in extremity First Vaccine on 3/29/2021 to right arm. Injection site was swollen, red, hot to touch, and itchy fo... Read more
First Vaccine on 3/29/2021 to right arm. Injection site was swollen, red, hot to touch, and itchy for one week post vaccine. On 4/5/2021 the tips of my fingers and toes were painful, reddened, and swollen. Meds: Tylenol and Bendaryl were taken with resolution on 4/9/2021. On 4/11/2021 tips of fingers and toes became painful, reddened, swollen again. Remains that way now with Tylenol and Benadryl, including intermittent pain in my calfs and thighs, along with a slight headache.
47 2021-04-13 pain in extremity I woke up a little after midnight Friday morning with significant arm pain, nausea, diarrhea, fever ... Read more
I woke up a little after midnight Friday morning with significant arm pain, nausea, diarrhea, fever and intense body aches. The body aches continued for the rest of the night and throughout the next day. Started to feel better on Saturday, but then developed stiffness on the left side of my neck in the afternoon. Sunday night I woke up in the night with the feeling that the room was spinning, but I had no nausea. I continue to have fatigue, brain fog and a feeling of vertigo.
47 2021-04-13 tingling Dizzy; lightheaded; warm tingly arm; tongue swelling; fast heart rate; This is a spontaneous report ... Read more
Dizzy; lightheaded; warm tingly arm; tongue swelling; fast heart rate; This is a spontaneous report from a contactable Other HCP.A 47-years-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot noEL3247, Expiration date: unknown), via an unspecified route of administration anatomical location Right arm on 28Jan2021 12:30PM at single dose for COVID-19 immunization. Patient medical history included Hypothyroid, depression,add, Known allergies: Diflucan. Concomitant medication included Levothyroxine, Valacyclovir, Bupropion, Pepcid. On 28Jan2021 at 12:30 PM patient experienced Dizzy, lightheaded, warm tingly arm, tongue swelling, fast heart rate.resulted in: [Emergency room/department or urgent care] patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient was not diagnosed with COVID-19; Since and prior to the vaccination. The outcome of the events was Recovering
47 2021-04-14 pain in extremity On Wednesday 4/14/21, Left Lymph Node area painful. By Thursday 4/15/21 pain was a less but felt lik... Read more
On Wednesday 4/14/21, Left Lymph Node area painful. By Thursday 4/15/21 pain was a less but felt like it (the pain) was running down the underneath of my left arm through my elbow.
47 2021-04-14 pain in extremity Pain in the opposite arm that was vaccinated. The pain worsened the week after the shot and now the... Read more
Pain in the opposite arm that was vaccinated. The pain worsened the week after the shot and now the pain is severe in the opposite shoulder. In a resting position, it feels like shoulder muscles are detaching. I have a crackling and popping sound in the shoulder.
47 2021-04-14 pain in extremity Sore arm evening of first shot. Aching hips and shoulders two days after first shot.
47 2021-04-14 tremor, numbness Fatigue, dizziness, numbness in toes, shakes, brain fog
47 2021-04-14 tremor left hand tremor and fasiculations
47 2021-04-15 cold sweat, tingling Started with tingling of fingers within 15 minutes of vaccination. Another 15 minutes patient develo... Read more
Started with tingling of fingers within 15 minutes of vaccination. Another 15 minutes patient developed tightness in throat and whole arm began to tingle. Patient seemed okay and then at 11:26 AM patient felt sick and felt like throwing up and dizzy then patient rolled eyes back into head. She was pale and clammy. Epinephrine was then given at 11:28 AM. Upon administration of epinephrine patient woke up and took a deep breath. She was then picked up by ambulance. Patient was oriented x 3. Vitals were stable (Oxygen 98 %. Heart rate was 68, BP 100/68).
47 2021-04-15 pain in extremity, bell's palsy, discomfort Day 1 Nausea Dehydrated Headache Fatigue Felt heavy, freeze/stabbing pitch fork headache all day D... Read more
Day 1 Nausea Dehydrated Headache Fatigue Felt heavy, freeze/stabbing pitch fork headache all day Day 2 Headache Fatigue Arm pit itch Teeth pain and clinching (neurological uncontrollable) vertigo/dizzy Stiff neck sore muscles and joints Day 3 Fatigue Headache Day 4 Fatigue Ankles got really swollen Out of breath on just a walk Headache Shooting Pain in legs and feet Pain at past mohs surgery site Day 6 Agitated Nauseous Dizzy Headache Bells palsy like symptoms right side of my face
47 2021-04-15 pain in extremity The guy that injected me did it very high on my right shoulder I immediately felt a sharp intense pa... Read more
The guy that injected me did it very high on my right shoulder I immediately felt a sharp intense pain that strangely went from my shoulder to the top of my hand. I left went home did nothing then by 5pm or so I now cannot move my right arm it?s literally like it?s locked up I feel it in the right side of my neck!! I was sitting in a low chair and he was tall did he screw up my arm ? I?m feeling like I should go to the urgent care center if it gets worse I?m going to have to. My main concern is did he did inject it in the wrong spot and what did he do to my arm?
47 2021-04-15 pain in extremity 4 days after my 2nd dose I developed arm pain and weakness in both arms. It has lasted for 8 weeks ... Read more
4 days after my 2nd dose I developed arm pain and weakness in both arms. It has lasted for 8 weeks now. On April 8th I broke out with shingles. I believe the shingles are attributed to the vaccine. I am currently treating the shingles and I still have the pain in both arms.
47 2021-04-15 tremor shaking/chills and fever (up to 100 degrees), headache, nausea, upset stomach. Resolved slowly but ... Read more
shaking/chills and fever (up to 100 degrees), headache, nausea, upset stomach. Resolved slowly but within 24 hours.
47 2021-04-15 unresponsive to stimuli Patient was given her first dose of the pfizer vaccine at around 915 am she had mentioned that she h... Read more
Patient was given her first dose of the pfizer vaccine at around 915 am she had mentioned that she had an allergy to penicillin but it wasn't an anaphylactic reaction. After the shot she went and sat in the chairs out front and shortly after someone called out that she needed help nurse ran to her side and she was unresponsive with shallow breathing and sweating and we called 911. As nurse was checking on her nurse 2 grabbed the epipen and administered right away. She came to after the epipen and we were able to talk to her a bit she mentioned that she has fainted a few times. We noticed that she had urinated at some point not sure if it was before or after epipen. The 911 operator suggested that we get her on the floor and have her lay down so we got her on the ground and laid her down as we were doing this she was going in and out of responsiveness. We attempted to take her blood pressure but the machine errored out a couple times. As we were trying to get the blood pressure the ambulance showed up and they took over care. She was transported to Clinic ER. She called later in the afternoon to let us know that she was doing okay and that she appreciated what we had done for her.
47 2021-04-16 flushing, numbness About 15 minutes later my face, neck, and chest flushed bright red and felt semi numb and like ants ... Read more
About 15 minutes later my face, neck, and chest flushed bright red and felt semi numb and like ants were crawling on me. My chest was also tight but no trouble breathing. Then ever since I?ve been nauseous. I?m rarely nauseous.
47 2021-04-16 flushing 14 hours post vaccine: severe body aches, chills, fever 102/flushing, headache, nausea. Lasted tot... Read more
14 hours post vaccine: severe body aches, chills, fever 102/flushing, headache, nausea. Lasted total of 24 -36 hours
47 2021-04-16 pain in extremity left arm soreness; fatigue; This is a spontaneous report from a non-contactable consumer. A 47-years... Read more
left arm soreness; fatigue; This is a spontaneous report from a non-contactable consumer. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jan2021 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Latex. The patient's concomitant medications were not reported. On an unspecified date, after the 1st shot the patient experienced. left arm soreness and fatigue. The outcome of the events was unknown. The patient received treatment for the events. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. The patient received second dose of bnt162b2 (lot number: EL3247) on 04Feb2021. No follow-up attempts are possible. No further information is expected.
47 2021-04-17 inability to speak, numbness while sitting right arm went numb, then couldn't get words out to speak and was confused; was taken... Read more
while sitting right arm went numb, then couldn't get words out to speak and was confused; was taken to hospital and given tests (MRI, CT scan, COVID test, echocardiogram, chest X-ray); numbness went away first day, MRI showed TIA/mini strokes on left side of brain and insula part of brain; had aphasia for two days; admitted to hospital for observation and released after 3 days; given Lipitor and aspirin and heparin shots for treatment; no lasting effects from stroke; doctor says cholesterol, blood pressure and family history normal;
47 2021-04-17 breast pain, pain in extremity Arm pain started approx 10 hours after second shot. Aching/throbbing from shoulder to wrist and und... Read more
Arm pain started approx 10 hours after second shot. Aching/throbbing from shoulder to wrist and underarm/breast area on side of shot. Lasted approximately 40 hours. Tylenol managed pain. Extreme tiredness during same timeframe. No reaction to first shot.
47 2021-04-17 feeling hot, tremor, seizure During observation period member had what appeared to be a seizure lasting less than 1 minute - head... Read more
During observation period member had what appeared to be a seizure lasting less than 1 minute - head fell back, rolled eyes, trembling. Confused when episode ended for about 15-20 seconds then became oriented and answering questions appropriately. Patient vomited face became very pale, complained of feeling hot and "not right' transported to ER via EMS
47 2021-04-17 hot flush April 17th 10:28 Took Vaccine 10:45 Reaction started with tightening of my throat and drank some wat... Read more
April 17th 10:28 Took Vaccine 10:45 Reaction started with tightening of my throat and drank some water 11:00 ish gums started swelling and lips tingling My hands and tongue started swelling and my face was warm 11:15 ish-took 25 mg Benadryl via shot 12:27-arrived at ER for monitoring 2:22-took Pepsid and steroid ( dexamethasone) orally 4:00-50 mg of Benadryl orally 10:00 pm- 25 mg Benadryl and Pepsid tablet April 18th Symptoms: ? Face flushed and stretched ? Face and neck itchy / small hives ? Mentally scattered ? Auras Headache 4:00 am - 50 mg of Benadryl oral 10:00 am - 25 mg of Benadryl oral 10:00 Pepsid 11:00 Tylenol 4:00 Tylenol 6:00 Benadryl 7:25 Imetrex
47 2021-04-17 numbness, feeling cold, muscle spasms, cold extremities After getting the 2nd dose of the Pfizer vaccine I had a difficult time breathing and I was also ver... Read more
After getting the 2nd dose of the Pfizer vaccine I had a difficult time breathing and I was also very sleepy. After the 15 minutes I left. When I went home, I was still very tired, my whole body felt cramped and strained. That day at around 11pm I started to feel very cold. No matter what I put on my body would not heat up. Then after a while I got a fever which cause my whole body to heat up. It felt like there was fire inside. At around 3 o'clock in the morning hands froze they became rock solid. They were unable to move. After eating 2 tablets TYLENOL the hands where no longer rock hard but became numb. I went to sleep, and the fever went away. From yesterday till now I have had dizziness, headache, numbness. When I ate food this morning, I ate little and threw up most of it. At around 5 pm I got another fever and ate 2 tablets of TYLENOL and the fever started to go away.
47 2021-04-17 numbness Numbing feeling on lower left side of face, lips, chin, and inside of mouth
47 2021-04-18 numbness, tingling ITCHING, RAISED REDDENED BUMPS OVER ENTIRE BODY - TRUNK, BACK, ARMS, LEGS, HANDS, FEET, NECK, FACE, ... Read more
ITCHING, RAISED REDDENED BUMPS OVER ENTIRE BODY - TRUNK, BACK, ARMS, LEGS, HANDS, FEET, NECK, FACE, EARS. NUMBNESS, TINGLING, WARMTH WITH RASH.
47 2021-04-18 tingling PFIZER SEVERE SKIN ALLERGIC REACTION WITH SEVERE ITCHING AND WELTS/ BLOTCHES ON SKIN ALL OVER BODY. ... Read more
PFIZER SEVERE SKIN ALLERGIC REACTION WITH SEVERE ITCHING AND WELTS/ BLOTCHES ON SKIN ALL OVER BODY. RED LARGE RAISED BUMPS. PINS AND NEEDLES RED AND HOT
47 2021-04-18 tenderness 103. fever began 12;30 Saturday morning , body aches, headache felt like my head was going to explo... Read more
103. fever began 12;30 Saturday morning , body aches, headache felt like my head was going to explode. fever of 102 continued into Sunday morning severe arm pain at sight of injection also underarm tenderness. all of my armpit glands are swollen around inside of my arm near left breast. fever finally subsided Monday morning.
47 2021-04-19 burning sensation, pain in extremity My arm was sore a couple days. Felt tired Wednesday, then Thursday, Friday and Saturday I felt exha... Read more
My arm was sore a couple days. Felt tired Wednesday, then Thursday, Friday and Saturday I felt exhausted. My muscles and joints hurt. On Saturday I had a little headache and the skin right below my eyes was red and felt like it was burning a little.
47 2021-04-19 feeling cold, pain in extremity, flushing Dizziness: right after shot Arm soreness and couldn't lift my arm, facial flushing, chills : after... Read more
Dizziness: right after shot Arm soreness and couldn't lift my arm, facial flushing, chills : after approximately after 5 hours Severe facial itchiness with red patches on the face and neck: started next dat and last 3 days
47 2021-04-19 flushing Patient was flushed and stated she was having throat tightening. Vitals taken immediately BP 131/89... Read more
Patient was flushed and stated she was having throat tightening. Vitals taken immediately BP 131/89 HR 87 R20 O2 97% Patient taken immediately to urgent care for higher level of care and treatment.
47 2021-04-19 muscle spasms 1. Menstrual started 2 weeks earlier 2.. Cramps 3. Stomach pain I have not went to be treated. I am ... Read more
1. Menstrual started 2 weeks earlier 2.. Cramps 3. Stomach pain I have not went to be treated. I am still going through the pain.
47 2021-04-19 pain in extremity, breast pain At the time of the administration of the vaccine I felt a strong pain that I can describe in the who... Read more
At the time of the administration of the vaccine I felt a strong pain that I can describe in the whole body, since that day I started to feel bad, severe pain in the arm with swelling, pain in the breast and neck ... the pain is very acute, it has been increasing, I have visited the emergency room, emergency and my primary doctor and even to this day I am still the same, I have had not had improvement
47 2021-04-19 pain in extremity Arm pain, body pain nausea and headache.
47 2021-04-19 restless legs syndrome, pain in extremity Restless legs , severe pain in legs - had to keep moving which was hard because was already tired. F... Read more
Restless legs , severe pain in legs - had to keep moving which was hard because was already tired. Fatigue.
47 2021-04-20 weakness Weakness, chills, mild temperature 100.1
47 2021-04-20 feeling cold, tingling, numbness 1. injection site pain, swelling for ~7days ... Read more
1. injection site pain, swelling for ~7days 6. joints pain 2. unable to lift up arm pass 15-degree angle for days 7. fatigue 3. left arm got numb/tingling, cool to touch- required long sleeve shirt & gloves (resolve next day) 4. itchiness of throat for ~3-4 days 5. generalized body aches for @ least ~ 5 days
47 2021-04-20 feeling hot, flushing After about 20 minutes following the administration of the vaccine, pt felt warm, flushed, and wheez... Read more
After about 20 minutes following the administration of the vaccine, pt felt warm, flushed, and wheezy. Vital signs obtained and lung sounds asculatated. 911 was called, pt declined transport to ED for eval as pt verbalized improved symptoms.
47 2021-04-20 feeling hot COVID-19 Vaccine administered in left IM deltoid around 6:30pm for the 2nd dose in the series. Appro... Read more
COVID-19 Vaccine administered in left IM deltoid around 6:30pm for the 2nd dose in the series. Approximately 30 minutes after patient stated she's not feeling well and feel really sick to her stomach and nauseous and feeling hot. Tried to cool her off with fanning and cool wet towel but started to feel more severely nauseous and 911 EMS was called. they checked her vitals and ended up walking her out to her car.
47 2021-04-20 muscle spasms, facial pain Neck pain/ spasm left sided - severe pain that lasted 1 week - moderate pain that lasted 2-3 additi... Read more
Neck pain/ spasm left sided - severe pain that lasted 1 week - moderate pain that lasted 2-3 additional weeks... mild issue still Left-sided - Ear / Jaw and face pain started about 20 mins after vaccine and lasted 3-4 days
47 2021-04-20 nerve pain Shingles rash appeared. Where the rash was, I had severe back/nerve pain. I've had shingles several ... Read more
Shingles rash appeared. Where the rash was, I had severe back/nerve pain. I've had shingles several times in the past, so I immediately contacted my doctor. I had a video appointment and she looked at the rash and said it's shingles. She prescribed an antiviral, gabapentin, for the intense nerve pain and an antiviral cream that has cortisone in it. I was extremely sick from the shingles, this was day 2 or 3 after the first dose of Pfizer. Extreme fatigue, shingles rash, and the worst nerve pain I've ever had in my life. I nearly went to the ER (it was that bad). Over the course of 2 weeks it got better. But boom, 2 days after the second shot the shingles rash made a comeback. Same spot. Doctor called in an extra two weeks of shingles meds. The nerve pain got better than it was, but I'm still not 100 percent well. I'm still having bouts of fatigue and severe nerve pain from the shingles.
47 2021-04-20 night sweats Woke up the day after my shot with achy muscles and felt very slow. Went to work and after a long d... Read more
Woke up the day after my shot with achy muscles and felt very slow. Went to work and after a long day was spent. Achy muscles, shivering, night sweats, abdominal pain, diarrhea, vomiting and mid level to high fever...the highest at 103.9. I haven?t had all the symptoms every day. I have experienced achy muscles, shivering and fever daily. Have been taking acetaminophen, 1000 mg every 6 hours. Pushing water and tea, only able to eat soup or vegetable smoothies.
47 2021-04-20 pain in extremity Very strong pain on my left leg. I had my shot at 11am. By 9pm I started feeling a mild pain on my l... Read more
Very strong pain on my left leg. I had my shot at 11am. By 9pm I started feeling a mild pain on my left knee. By 1am I was in a very strong pain. I couldn?t move. By 5 am I had 400mg of Advil. By 8 am I was at the Urgent care. The person didn?t have any major concerned and sent me home. Today is 4/21 and the pain is much better. I can?t still bend my leg but overall it is better.
47 2021-04-21 weakness, pain in extremity 4 days after my first pfizer shot I began experiencing pain and weakness in my hips and legs. I was... Read more
4 days after my first pfizer shot I began experiencing pain and weakness in my hips and legs. I was feeling fine during the day, normal exercise, and by nighttime I couldn't walk down my stairs and it has persisted ever since. It's pain and discomfort in the front of my hips and down my legs causing weakness - walking is very difficult. I have about 30% leg strength.
47 2021-04-21 feeling hot "pt felt warm hot at the right side of the neck and ear and a lot of pressure in front of the head. ... Read more
"pt felt warm hot at the right side of the neck and ear and a lot of pressure in front of the head. also, pt's throat felt tight."
47 2021-04-21 numbness, feeling cold She got her vaccine, she didn't feel the needle, did not have any symptoms including soreness. The... Read more
She got her vaccine, she didn't feel the needle, did not have any symptoms including soreness. The next day her arms feel clogged or that the blood supply is not falling properly, like they are falling asleep. From her shoulders down to her fingers. Her arms kind of feel cold. It doesn't matter which position they are in, propped up, hanging down, the feeling does not go away and also feels it when she is in bed. He saw her PCP and she felt that Pfizer is the least amount of side effects and if she got the 2nd one it would happen again and perhaps to a more degree. She ordered the antibody test to see if she had ever had COVID. She said that they could try a steroid to see if it was swelling related. Then if that did not work then they could send her to a neurologist to do a nerve test. She prescribed steroid pills for her to take, this was this morning.
47 2021-04-21 muscle spasms, slurring 17 hours post vaccine had chills, profuse sweating, headache, nausea, lethargy, lack of appetite. ... Read more
17 hours post vaccine had chills, profuse sweating, headache, nausea, lethargy, lack of appetite. 44 hours post vax - felt better and decided to take a shower. Felt faint in the shower. Returned to bed and went into a full body cramp. My arms, hands, legs, feet all went into a severe cramp. My husband was unable to extend my arms or get my fingers to unfurl. I was in extreme pain. My lips started tingling and my word started slurring. My husband called 911. I was diagnosed with dehydration and low potassium. My potassium was 2.6 I received 3 bags or fluids. Pain meds. A potassium drip and oral potassium at the emergency room.
47 2021-04-21 pain in extremity, night sweats, discomfort High/Drunk feeling within 1 hour of shot, Not able to sleep at night for first 72 hours (2 hrs 1st ... Read more
High/Drunk feeling within 1 hour of shot, Not able to sleep at night for first 72 hours (2 hrs 1st night, 4 hours 2nd night, 4 hours 3rd night), Very low mood and wishes I would die on 4/15 morning as pain/discomfort was so great. Severe Chills (shaking, needed 3 blanket) from late afternoon to early morning hours during the 1st 72 hr post injection, Severe night sweats 1st 3 nights - body was soaking wet and soaked through pajamas, Joint and muscle pain in arms, legs, face/jaw starting the 1st night after injection and continuing for 4 days after injection, Swollen, painful lymph nodes in under arm/neck - continues to this day (started night 1 and now 9 days after injection), Occasional dizziness when standing and sitting starting 4 days after injection and continuing for 48 hours, Blurred vision, people looks like they were swaying starting day 5 through day 6, Very Heavy vaginal bleeding started on day 7 (4/20), got worse on day 8 (4/21), and the same on day 9 (4/22): soaking through pad every 2-3 hours on day 8 and day 9. bleeding continues at time of this report. NOT like a period, or timing of my period. My period is not due to start until 4/25 and I have been regular my entire life - 36 years! Cough and left arm pain started on day 8 (4/21) - I went to ER after calling my OBGYN and talking with the nurse. NEVER had a fever, NEVER had cramps.
47 2021-04-21 tingling Anaphylaxis symptoms: tingling, dizziness, mouth and throat swelling and chest tightness warmth. I ... Read more
Anaphylaxis symptoms: tingling, dizziness, mouth and throat swelling and chest tightness warmth. I administered my Epipen in the car and my father drove me to the ER where I received:Benedryl, Pepcid, soul-medrol, and sodium chloride.
47 2021-04-22 feeling of insects crawling on skin Patient developed formication; followed by dyspnea, sensation of swelling of lips/throat, and nausea... Read more
Patient developed formication; followed by dyspnea, sensation of swelling of lips/throat, and nausea.
47 2021-04-22 grand mal seizure Patient received her second Pfizer vaccine on 4/12/2021. On 4/19/2021 patient had a localized right... Read more
Patient received her second Pfizer vaccine on 4/12/2021. On 4/19/2021 patient had a localized right sided tonic-clonic seizure, evaluated at local ER. Patient has no prior history of epilepsy or seizure disorder. Patient has no history of drug/alcohol use.
47 2021-04-22 numbness Patient received 2nd dose of Pfizer Covid-19 vaccine and during post vaccination waiting period she ... Read more
Patient received 2nd dose of Pfizer Covid-19 vaccine and during post vaccination waiting period she reported feeling numbness on her lips, gums and left cheek. She reports taken a children's dose of Benadryl at around 10:55. Patient is able to talk and is breathing normally but has a small rash on her cheek. Patient indicates that she has an extensive list of allergies to medications and foods. Patient is not taking medications currently . Her BP is 169/113 p is 91. At 11:06 Patient had developed a rash on her face, ears ad her chin as well as a large area on her chest. EMT on site- evaluated Patient and administered Epi pen (lot DFM355 exp 11/21) on the left thigh at 11:10am. 911 was called and EMS transported Patient to the hospital. Patient's husband is by her side.
47 2021-04-23 feeling cold Swollen lymph node (right arm pit), violent chills, wave of cold spots at top of shoulders to base o... Read more
Swollen lymph node (right arm pit), violent chills, wave of cold spots at top of shoulders to base of neck and back of skull.
47 2021-04-23 numbness tia in right eye, on Friday morning on 4/16/ 21, between the hours of 8 am and 9:30 am, I went from ... Read more
tia in right eye, on Friday morning on 4/16/ 21, between the hours of 8 am and 9:30 am, I went from feeling fine and sleeping to waking up not being able to hear in both ears, not being able to see anything out of my right eye, my left arm was completely number all the way up to my shoulder and neck, the right side of my tongue was numb and my blood sugar was over 611. Initially they thought it was just a reaction to my high sugar levels, since the mri's showed I did not have evidence of a stroke. It wasn't until I saw a retina specialist the following Tuesday that she confirmed that yes I did have a stroke in my eye. I have not recovered my vision fully in my eye or the sensation in my tongue. I didn't connect it to the vaccination until I spoke with a friend whose sister also got pfizer 5 days before me and suffered a stroke 3 days before me, and two days after we spoke they announced Johnson& Johnson pause due to clots in women. The retina specialist says we will have to wait and see if the damage heals on it's own in the meantime I need to see her on a monthly basis.
47 2021-04-23 pain in extremity No side effects for 7hrs, then injection sight slightly sore at 9p Thursday 4/22, 8a Friday 4/23 ent... Read more
No side effects for 7hrs, then injection sight slightly sore at 9p Thursday 4/22, 8a Friday 4/23 entire left arm ached and all joints ached. By noon 4/23 increased aches in joints and tired. By 4p 4/23, exhasted and took 2hr nap. At 5p woke to severe aches all over body ( muscles & joints). Fell asleep at 6pm 4/23, when awoke at 7a 4/24 exhaustion gone and only slight joint aches remained. 10a body seems To returning to normal as aches continue to subside and I have energy again to do things.
47 2021-04-23 tremor, feeling hot Patient complained of dizziness and lightheadedness about 10 minutes after receiving vaccine, had vi... Read more
Patient complained of dizziness and lightheadedness about 10 minutes after receiving vaccine, had visible tremors. Requested a cool cloth, was feeling hot. No complaints of problems breathing or swelling. No 'racing heart.' No EpiPen given. EMS arrived and took her to local ER. Patient was conscious and oriented entire time.
47 2021-04-24 weakness, cold sweat kidneys started hurting; UTI; heart pain; nausea; heart racing; blood pressure started going up; col... Read more
kidneys started hurting; UTI; heart pain; nausea; heart racing; blood pressure started going up; cold sweat; weak/did not have energy to talk; blood pressure was too low; This is spontaneous report from a contactable consumer reported for self. This 47-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8732) at single dose in left arm on 30Mar2021 01:45 PM for COVID-19 immunization. Medical history included nephrocalcinosis. Patient had allergies to contrast of iodine, had an anaphylaxis when they injected with iodine for checking her kidney, it was over 20 years ago. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, with a minute taken the covid vaccine, patient started feeling nausea and heart racing. Her blood pressure started going up. The facility kept checking blood pressure and oxygen. After a bit, patient had no idea of time she felt a cold sweat and very weak. Patient did not have energy to talk. However, patient saw the nurse with an epi pen and she was able to tell that she was breathing. Doctor said that her blood pressure was too low. It had dropped to low 80. Patient kept trying to relax and suddenly it went all the way up again. Her normal blood pressure was 110/70 or 120/80 and it was 150/98. Patient started getting heart pain was taken to the ER and an ECG was made and her heart was ok. Her blood pressure stayed high. Patient kidney disease. Specifically, nephrocalcinosis; however, her kidney function still good. In the second day after the vaccine, on 31Mar2021, her kidneys started hurting and she felt like she was having an UTI (urinary tract infection) what she did not have had in the last year or so. All the adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for all events was reported as unknown. The outcome of events was resolving.
47 2021-04-24 feeling cold Chills, headache, fever, muscle aches, swollen lymph node in armpit.
47 2021-04-24 nerve pain, tingling, migraine, burning sensation Shingles outbreak on upper left lip and face, extreme ear and facial nerve pain, burning and tinglin... Read more
Shingles outbreak on upper left lip and face, extreme ear and facial nerve pain, burning and tingling, migraine for 4 days, and severe fatigue for 7 days
47 2021-04-24 pain in extremity, flushing I felt fine the first 12 hours after the shot other than a little bit of brain fog. 12-36 hours aft... Read more
I felt fine the first 12 hours after the shot other than a little bit of brain fog. 12-36 hours after the shot, I felt terrible. I was achy, sweaty, had chills, no appetite and two waves of nausea. I had trouble sleeping. I ate very little during this time (toast, banana, soup), and threw up once. I had to rest all day. My left arm hurt and my lymph node by my left armpit hurt. (I have had ultrasounds over the past couple of years of my left breast/armpit taken due to an enlarged dense lymph node discovered on a mammogram. The ultrasounds have showed no increase in growth, and no signs of cancer.) I started feeling better 36 hours after the shot. It's now just over 48 hours post-vaccine. The lymph node pain remains and if I try to do anything even mildly strenuous I get flushed and tire easily, so I have been mostly resting. This was my second shot.
47 2021-04-24 pain in extremity severe rash on left leg and hip 4 days after shot. Immediately after shot, pain in left hand.; sev... Read more
severe rash on left leg and hip 4 days after shot. Immediately after shot, pain in left hand.; severe rash on left leg and hip 4 days after shot. Immediately after shot, pain in left hand.; Shingles Variant; This is a spontaneous report received from a contactable consumer. This 47-year-old female consumer (Patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot_number=EN6207) at single dose for COVID-19 immunization on 25Mar2021 at 08:30 AM. Relevant history included high blood pressure and Bi-Polar II. Relevant concomitant drug received within 2 weeks of vaccination included Ambien, Linsilpril, Seroquel, Paxil. The patient experienced severe rash on left leg and hip 4 days after shot (on 29Mar2021 at 08:00 AM). She was still diagnosing, but thinking a Shingles Variant which was Very Painful. She was awaiting dermatologist review. Treatment therapy included Triamcinolone, Gabapentin, Valacyclovir, prednisone. Outcome of events was not resolved. The event was assessed as non-serious. Due to the events the patient visited Doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID prior vaccination. The patient had not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are possible. No further information is expected.
47 2021-04-25 weakness Shortness of breath, couldn?t walk (legs felt like in cement), lightheaded, and hard to keep eyes op... Read more
Shortness of breath, couldn?t walk (legs felt like in cement), lightheaded, and hard to keep eyes open.
47 2021-04-25 weakness Client reported symptoms of dizziness and weakness. Fire Department first responded. Client prese... Read more
Client reported symptoms of dizziness and weakness. Fire Department first responded. Client presented hypotension. Clients BP recovered within normal limits. Client stated she felt good. No further treatment needed as per Fire Department. Client was released to home at 10:10am.
47 2021-04-25 migraine Fever for 12 hours with migraine. Once recovered had problems with controlling blood sugars where t... Read more
Fever for 12 hours with migraine. Once recovered had problems with controlling blood sugars where the medication was not as effective and causing problems with blood sugar that was being controlled having problems with controlling the levels and increased dosages only providing mild help.
47 2021-04-25 tingling, numbness I have had multiple diverse reactions, and I will report each one as a separate entry (based on time... Read more
I have had multiple diverse reactions, and I will report each one as a separate entry (based on time of onset). Immediately upon receiving the first immunization, my entire left arm began tingling and then turned numb. This lasted for 2 days (partial feeling, partial numbness/tingling) down arm and also hand and fingers. About two hours after the shot, neck and face turned dark red and began burning. This lasted for that evening. Allegra taken.
47 2021-04-25 tremor 7 minutes after vaccination: shortage of breath, high blood pressure 148/96, irregular and intense h... Read more
7 minutes after vaccination: shortage of breath, high blood pressure 148/96, irregular and intense heart beat, intense body shaking. I was taken to emergency hospital right away for next 6 hours and then released home. Following day after vaccination: pain in the kidneys' area started, light pressure in the heart area Second day after vaccination: pain in the kidneys' area, lower and upper back pain, low blood pressure part of the day (94.5 F) Kidney area still in pain.
47 2021-04-25 unresponsive to stimuli Pt observed unresponsive. Pt responded after vitals, Vitals stable A & O x4. Says she does this w/ a... Read more
Pt observed unresponsive. Pt responded after vitals, Vitals stable A & O x4. Says she does this w/ any vaccine. Refused transport.
47 2021-04-26 bell's palsy, nerve pain diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/... Read more
diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/swollen glands; swollen injection site; tired; mouth ulcers; extreme nerve pain; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 08Apr2021 15:00 (Batch/Lot number was not reported) at single dose (at the age of 47 years old) for COVID-19 immunisation. Medical history included "if covid prior vaccination: Yes". Concomitant medications included potassium, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cetirizine and chlorthalidone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation. The patient reported, "fever, muscle aches, headache, throwing up, chills, swollen lymph nodes, swollen injection site, tired. After chills, fever, throwing up, mouth ulcers. On day 7 I have extreme nerve pain, swollen glands, and paralysis on left side of face. Went to DR and they diagnosed with Bells Palsy. Left side of face does not move at all", 09Apr2021 09:00. The patient received no treatment. The outcome of bells palsy, extreme nerve pain, mouth ulcers and swollen lymph nodes/ swollen glands were not recovered and other events was recovering. Information about lot/batch number has been requested.
47 2021-04-26 hot flush Bad headache; Stomach ache; Chills; Hot flashes; Aches all over; Fever; Nausea; This is a spontaneou... Read more
Bad headache; Stomach ache; Chills; Hot flashes; Aches all over; Fever; Nausea; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm on 17Feb2021 at 18:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's disease, endometriosis, GERD (gastrooesophageal reflux disease). Known allergies were none. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL) received in two weeks for birth control. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) on 27Jan2021 at 18:00 as a single dose in left arm for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient has not tested for COVID post vaccination. The patient experienced bad headache, stomach ache, chills, hot flashes, aches all over, fever, nausea on 18Feb2021 at 06:00 AM. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment medication for the adverse events. The outcome of the events was recovering.
47 2021-04-26 hot flush 1st time shot - after 5 minutes I had disoriented issues, hot flushes for about 5 minutes where I to... Read more
1st time shot - after 5 minutes I had disoriented issues, hot flushes for about 5 minutes where I took my shoes off in the car and mentally felt like I was having an anxiety attack so the ?attendant lady? said it was normal to have a #panicattack . Two weeks later I went to my 2nd shot, and thinking it was a previous ?anxiety attack? this time would be better. Same timing, same feelings happened that lasted about 3 minutes and it was extremely scary.
47 2021-04-26 pain in extremity, feeling cold No treatment at the time. If i couldn?t swallow a glass of water or couldn?t breathe would have gon... Read more
No treatment at the time. If i couldn?t swallow a glass of water or couldn?t breathe would have gone to ER. Nonstop headache for over a week. Saw Dr. today and it was better today otherwise she would have prescribed a steroid pack.
47 2021-04-26 pain in extremity, nerve pain The following events were only described to the author of this report 3 weeks after the events happe... Read more
The following events were only described to the author of this report 3 weeks after the events happened: A few minutes after the shot, the patient (pt) felt tightness in throat but still was able to breath. The pt then started feeling weird and a little dizzy in her head. This passed after about 15 minutes. The next day the pt woke up with nerve pain and soreness in the upper, inner part of her arms just above the elbow. The pt also reported nerve pain in the palm of hand below the thumb. The pt also reports having bad shin pain & muscle soreness. The shin pain lasted 4 days even after she took her regularly scheduled Celebrex along with Tylenol. Arm & hand pain only lasted a day.
47 2021-04-26 tremor Chills (shivering jaw), shaking, aches, fatigue, arm pain at injection site (inability to lift arm w... Read more
Chills (shivering jaw), shaking, aches, fatigue, arm pain at injection site (inability to lift arm without pain), general unwell feeling beginning the evening following the first dose of the COVID vaccine
47 2021-04-26 tremor Elevated heart rate and blood pressure, with dizziness, shakiness, sweating, headache, palpitations.... Read more
Elevated heart rate and blood pressure, with dizziness, shakiness, sweating, headache, palpitations. Patient monitored for 50 minutes, given water and snacks. Released home with husband.
47 2021-04-27 weakness 4/22- within minutes I felt dizziness and unsteady but was sporadic. As the day continued, became mo... Read more
4/22- within minutes I felt dizziness and unsteady but was sporadic. As the day continued, became more fatigued. 4/23 - Continued with previous symptoms and added headache, more fatigue, nausea, and chemical taste will all food/drink 4/24 - Continued with above symptoms and added: muscle aches, joint stiffness, extreme nausea and vomiting and weakness, severe fatigue. Went to ER for evaluation. (see below) Received IV fluids and Zofran In the 3 days since the ER visit, I am still unable to eat any solid food and can only drink after taking Zofran
47 2021-04-27 weakness chest pain; heart burn; chills; fever; body pains; terrible headache; tired; weak.; I had shortness ... Read more
chest pain; heart burn; chills; fever; body pains; terrible headache; tired; weak.; I had shortness of breath; This is a spontaneous report from a contactable consumer(patient). A 47-year-old non pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown) on 21Jan2021 at 04:00 PM via an unspecified route of administration in left arm at single dose for covid-19 immunization. Patient was 47 years old at the time of vaccination. Patient medical history and concomitant medications were not reported. Patient did not have any known allergies. Patient did not receive any other medications in two weeks. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination. On 21Jan2021 at 8PM patient had shortness of breath, chest pain, heart burn, chills, fever, body pains, terrible headache, tired, and weak. It lasted until 10AM the next day. Effects lasted for 12 hours. On 06Jan2021 patient tested for covid post vaccination with test name Saliva and result received was negative. The outcome of the events was recovered. Information on the lot/batch number has been requested.
47 2021-04-27 flushing Patient received 1st dose covid vaccine; during observation period experienced slight red rash acros... Read more
Patient received 1st dose covid vaccine; during observation period experienced slight red rash across chest, very slight facial swelling around lips, and facial flushing; patient stated this was usual reaction to vaccines; 50 mg benadryl given along with cool water; symptoms started to subside, patient felt ok, blood pressure was within normal range; patient was released after all symptoms gone (approx. 40 minutes total observation time) with recommendations if symptoms reappear to either go to ED or call PCP.
47 2021-04-27 numbness, tingling Tingling; Facial numbness on left side face; This is a spontaneous report from a contactable consume... Read more
Tingling; Facial numbness on left side face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number 588727) via an unspecified route of administration on 25Mar2021 at 08:00 (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications include fexofenadine (reported as "generic ALLEGRA") from an unknown date for an unknown indication. The patient did not have any allergies to medications, food, or other products. In the afternoon on the day of vaccine on 25Mar2021 at 14:30, the patient experienced facial numbness on left side face. She felt it more in cheek. As of 28Mar2021 the patient improved by still had numbness and tingling. The event was reported as non-serious. The patient was not hospitalized for the event. It was unknown if the patient received any treatment for the event. The outcome of facial numbness on left side face and tingling was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
47 2021-04-27 pain in extremity 4/25, 4pm, 2nd dose of Pfizer. Mass vax scheduling second dose 17days from 1st shot. 7pm, fatigue,... Read more
4/25, 4pm, 2nd dose of Pfizer. Mass vax scheduling second dose 17days from 1st shot. 7pm, fatigue, mild sore arm. 4/26/21 - 7am SEVERE BONE PAIN started in vertebrae, hip, coccyx, knees, ankles, completely unmitigated by 1000mg Tylenol and 800mg ibuprofen, FEVER - w/ meds still 99.7, CHILLS - moderate, DIARRHEA/NAUSEA - mild, fatigue - moderate, headache - mild, mitigated by meds. Would have gone to hospital if I thought they could do something. ABDOMINAL PAINS - intermittent, HEART FLUBBING - mild. 7pm, BONE PAIN reduced to moderate by 9pm, fever broke. 4/27/21 - felt like I had the flu - FATIGUE, CHILLS, NAUSEA, - all tolerable and mild-moderate, ABDOMINAL PAINS - intermittent, HEART FLUBBING - mild. 4/28/21 - FATIGUE - moderate (worse), ABDOMINAL PAINS - moderate, not gastro-related, HEART FLUBBING - mild. Third day missed of work. Heading to doctor.
47 2021-04-27 tingling Patient complained about dizziness, tingling of arms, and throat closing 5 minutes after the shot. ... Read more
Patient complained about dizziness, tingling of arms, and throat closing 5 minutes after the shot. Symptoms resolved after about 10 minutes and patient developed slight rash on chest.
47 2021-04-27 tenderness, breast pain Acute Pancreatic attack- sharp pain in upper left stomach radiating to upper left back, pain also in... Read more
Acute Pancreatic attack- sharp pain in upper left stomach radiating to upper left back, pain also in left breast lasting for approx 2 hrs and then somewhat relieved after taking Tums and phazyme. After 12 hrs stomach still mildly sensitive to touch and bloated.
47 2021-04-28 weakness, feeling cold It started with body ache and then terrible headache, chill, nauseous, tiredness, and overall weakne... Read more
It started with body ache and then terrible headache, chill, nauseous, tiredness, and overall weakness. Not so much fever (about 100) but felt cold. I was Covid positive in November 2020, and felt the symptoms were very similar to what I had back then. It lasted two full days and especially the headache was persistent and went on the morning on the 3rd day. Spent two full days in bed. Took Advil on the 1st day and 2nd day but it took 3-4 hours to start feeling the effect. I switched to Tylenol on the night of the 3rd day, but didn't feel it worked. Felt almost normal in the afternoon of the 3rd day, but the headache came back the same night and couldnt sleep. Finally felt recovered in the morning of the 4th day but minor headache. The 4th day afternoon was fine.
47 2021-04-28 flushing flushing face, chest cramping
47 2021-04-28 flushing Chills, tiredness, headache,muscle pain, nausea, cough, dry burning eyes, flushed face and chest.
47 2021-04-28 numbness 3 DAYS (4/19) AFTER VACCINE STARTING FEELING NUMBNESS IN LIPS THAT SLOWLY PROGRESSED TO SIDES OF FAC... Read more
3 DAYS (4/19) AFTER VACCINE STARTING FEELING NUMBNESS IN LIPS THAT SLOWLY PROGRESSED TO SIDES OF FACE, FORHEAD, CHIN AND EVENTUALLY IN THE HAIRLINE. WENT TO THE DOCTOR 4/26 WHEN IT BECAME IMPOSSIBLE TO IGNORE, THOUGHT I WAS HAVING POSSIBLE STROKE, THE DOCTOR SENT ME FOR A CT SCAN ON 4/26. I DID NOT REALIZE IT WAS A REACTION TOTHE VACCINE. I WAS LOOKING FOR A RASH OR ACHES WHICH I DID NOT HAVE. I WAS PERSCRIBED A STERIOD REGIME BY MY FAMILY DOCTOR WHICH I STARTED 4/28.
47 2021-04-28 numbness Within 15 minutes of getting the Pfizer vaccine my upper lip felt numb, also my chin/neck, along my ... Read more
Within 15 minutes of getting the Pfizer vaccine my upper lip felt numb, also my chin/neck, along my face mask, felt puffy but was not visibly puffy. I could swallow and breath. At 25 minutes I went to a RN and had my neck checked to make sure I would be fine to leave. I did not mention the numb upper lip because at 25 minutes it had gone away. At 12:30 AM on 4/20/21 I woke up not feeling well. My upper lip was again numb, and it had spread to my face (it felt puffy but was not visibly puffy), and the numbness had spread to both sides of my face to my ears, up to my eyes, and down to my chin/neck. I went to the ER. When I arrived at the ER, the numbness was not as bad as when I woke up. Since it was not getting worse. and my vitals were good, they released me. My face is still numb. The numbness always includes my upper lip plus other parts of my face. Also, the numbness spread to inside my mouth and to the back of my throat. The degree of numbness varies. Sometimes I think it's getting better, and then it gets worse. I am also still feeling sick, nausea, feeling of unwellness, and I get exhausted doing things that would previously not made me tired. On 4/27/21, around bedtime, inside my body started feeling hot & icy at the same time, that continued all day on 4/28/21, and still feels this way on 4/29/21.
47 2021-04-28 muscle spasms, pain in extremity, burning sensation, numbness, migraine It's 7 days later and I am still not well - face swelling, hot to the touch (similar to when I had s... Read more
It's 7 days later and I am still not well - face swelling, hot to the touch (similar to when I had staph infection) Nausea is new as of today, migraine has come back (was present up until yesterday afternoon and started to dissipate and now back in full force). I have had 17 concussions in my lifetime so it feels like that a bit, foggy, can't stand for long, fatigue. Here are my symptoms by days. Would have sent this sooner but couldn't function or look at screen- really sick. I am still sick and not sure if this is normal or I should be going to the ER or some type of doctor. 4/22/21 ? 2nd Shot at 10:35 am - @ 1:45 pm arm really started to get soar and hard to lift. Chills. Drossy. 4/23/21 ? After I awoke from the 1st night, I couldn't move my entire body's left side, I was dragging my left leg with me and couldn't lift my arm from my body or move it. exhausted felt drugged, like hangover, migraine and getting in car accident all in one. Kept dozing off. Slept a lot. Head felt similar to concussion. Unable to really walk. 4/24/21 ?Slept a lot during day. Arm and leg mobility better and I could finally feel my left fingers. So much pain so I finally took my 1st Tylenol muscle 8 hr at 9:38 am. Took another at 10:30pm. It helped for about 5 hours and then woke up with sharp pains again. At night, shooting pains in legs especially back of legs and burning I?m in a lot of pain so while I can now feel my left side and move my arm a bit better my legs are still in a constant state of shooting spasm and I can?t lay down, sit up, recline or anything. Nothing brings comfort. It?s like taking an electrical prod to my body. Arm still hurts (NOT at injection site) but can move it better now still feels like sinus infection. It?s like muscles are pizza dough and someone is pulling them, stretching them painfully with electrical current when you aren?t moving. Massive spasm all over back of legs hips from bottom down. Eyes really swollen. Did Sinus Rinse. Under my arm put and beside/behind my breast rib cage sore. 4/26/21 - Pain wakes as usual throughout the night but it?s 4:40am and the Tylenol has worn off. Pizza dough pulling and spasms in the legs. I?ve taken more Tylenol in the last 4 days than I have taken in the last 40 years. I felt like I didn?t have a headache when I got up but my legs were still streaming so I took another Tylenol and I have a headache and don?t feel good. I now am able to move arm but extremely painful like a log, I can lift it only 1.5 inches from my body which is more than I could before so it must be getting better. Head still feels similar to concussion with migraine. The headache is causing me to clinch teeth and the headache is not at the level it was but still pretty bad. None of this pre -2nd shot. When I was about 12yrs old I had Rheumatoid arthritis (or that was the drs explanation) and this is what it felt like, I couldn?t move my legs or my arms then. I did not take any Tylenol tonight. Shoot pains only wake me up 3 times although they are constantly there just the strength differs Dr?s have always said I have extremely high threshold for pain. I was finally able to brush my hair, afterwards my arms were shaking muscle wise and fatigued. Rash inside my ear and face blotchy. 4/27/21 ?No real change in symptoms except now I am seeing my face swell and eyes are still burning and painful. My face only on the left side more than right looks like a cabbage patch doll- swelling. Eyes sore and front of head hurts. Stuffy nostril only left one ? so I do another sinus rise today. Still feel drugged. Body is sore. Hard to move neck. Still in pain take Tylenol at 9:20pm. The pain woke me up multiple times and kept me up. It?s like someone is pulling my muscles like pizza dough. It is so painful. No position is comfortable. Woke up at 10:30, 11:45, 12:15, 2:21, 3:52, 4:05 and that was it couldn?t get back to sleep because of this pain. Don?t have a foam roller here but maybe an olive oil bottle I could use in the same manger or a tennis ball. I have to do something I can?t take this pain. 4/28/21 ? 8:32 am having trouble lifting my arm, very heavy fingers numb fatigued like I just lifted something really heavy by myself. I was finally able to move arms enough to was the dishes. Left side of face still swollen. Under my arm put and beside/behind my breast rib cage still sore. Finally, was able to take bath. Not hot because I didn?t want any more swelling. 4/29/21 ? Only woke up a couple of time and slept better so thought I would try to go for a walk outside today. My headache I thought was pretty much gone. I didn?t last more than 8 mins. I felt like I couldn?t stand, exhausted, not strong enough and needed to sit down. My migraine is back and I feel nausea, not hungry, face is swollen still. I have lymphedema and use my machine every night, but it?s almost like the shot increases inflammation all over my body, find the places that have been affected before and gets in there. I only drink water, no coffee, tea or juice and no alcohol since 3 days before my 1st shot and was planning to continue that until 2 months after my 2nd shot.
47 2021-04-28 muscle spasms, tingling, pain in extremity Within 15 minutes of getting vaccine dizzy, lightheaded and nauseous, pins and needles tingling sen... Read more
Within 15 minutes of getting vaccine dizzy, lightheaded and nauseous, pins and needles tingling sensation down left side of body For the past week I've been incredibly nauseous and having leg pain and aches constantly. Plus fatigue. Still feeling pins and needles sensation off and on
47 2021-04-28 pain in extremity Pt states that she developed right forearm pain and swelling the day after. She was seen by me on 4/... Read more
Pt states that she developed right forearm pain and swelling the day after. She was seen by me on 4/29/21 and diagnosed with DVT radial and cephalic veins. Also with SVT of the fore arm.
47 2021-04-28 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
47 2021-04-29 flushing, tremor 7 minutes after vaccination, patient develops flushed sensation and heart palpitations. Vitals sign... Read more
7 minutes after vaccination, patient develops flushed sensation and heart palpitations. Vitals signs assessed: BP: 160/76, HR111 (regular rhythm), , 02- 100% RA Recheck: 159/92, HR 130 Pt shaking, denies difficulties breathing or troubles swallowing Emergency Response Team called- Transported Pt to Emergency Room for evaluation
47 2021-04-29 numbness, tingling Numbness, tingling, burning bilateral feet and hands
47 2021-04-29 pain in extremity Rash , swelling , itchy And pain experienced on the arm after 1 week of vaccine 1 st dose
47 2021-04-30 feeling cold, pain in extremity This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (the patient) r... Read more
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (the patient) reported that a 47-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206; Expiration Date: 30Jun2021) via an unspecified route of administration in left arm on 02Apr2021 17:00 at age of 47-year-old at single dose for COVID-19 immunisation. Medical history was reported as "none". Concomitant medications included ergocalciferol (VIT D), collagen, biotin, curcuma longa (TURMERIC), aloe vera, malus domestica (VINEGAR APPLE CIDER PLUS), and all of the natural vitamins. The patient took these every singe day. She was taking all the above vitamins because she was 47 years old and she wanted her skin different and she wanted to prevent the COVID. She had oil essence that she put on every single day and she had for more than one year it was the essential oil that she put in her diffuser with water and it was to prevent sickness. None prior vaccination within 4 weeks prior. Relevant Family History related to AE(S) was none. The patient received her 1st dose of Pfizer vaccine on 02Apr2021. She received a positive COVID test result on 04Apr2021. After 10-11 days she felt really good, she had only mild symptoms. She just had one or two days of body aches and that's it. 2nd dose was due 23Apr2021. The patient said she did not get COVID from the vaccine but was positive because of her husband who has allergies and cough every day of the year. He caught COVID at the restaurant (One family had invited them to go to a restaurant with them and inside the restaurant it was crazy. There were more than 80 people in there and that's it, after that her husband got the positive COVID test and then her daughter and then finally her), but they did not know because the symptoms were exactly the same as his pollen allergy. When she had the vaccine she had COVID in her body already. The only thing that she felt after the vaccine was a little cold (Apr2021), but the weather in the city was crazy, the temperature was around 50 and she said "oh perfect," she was going to get a cold after the vaccine. She thought that it wasn't the vaccine that caused it, she caught a cold because suddenly the weather was around 50 and she told her daughter that she needed a sweater and she gave her sweater to her daughter and she thought that she got a cold, but that was the only thing she felt. Another thing, when they put the vaccine in the area where she got the vaccine it was a little pain after the vaccine and she could feel it in her muscle. That was the only thing. It was muscle pain but only a little one. She thinks that began around the second day, 03Apr2021. She confirmed that she has recovered completely and added that currently she felt perfect. Caller said that she didn't remember when her muscle pain ended, it disappeared. The person that is with the department of health said that the caller didn't need to repeat her COVID test but she said that she was going to repeat her test because she wanted a negative test result. The person she spoke to said to wait 19 days to do the test because she can get positive results and then after 10 days she would not be contagious anymore. She would be able to walk outside of her house because she would not be contagious but the caller said that she wanted to wait until she got a negative result because COVID had got all of her family, her little one, her husband and her. The person that entered the COVID virus in her house was her husband. But she was confused because every single day of his life he has a cough. She thought the pollen was heavy outside and he coughed from that and then the same day they she the vaccine they had the same appointment. She told her husband to go to the doctor and asked if he can still have the vaccine and see if he has allergies so hard and that is it. He wasn't having allergies, it was COVID. Probed if the caller's husband had the COVID vaccine the same day that she did and she said that her husband had cancelled his appointment. The only person that has received the COVID vaccine that day was her because she thought that she just had the same allergy that he was having. She felt something about two days ago and said "what?" but she had to attend to everyone in the house and honestly she didn't have enough. Just had one or two days of body aches: She got her vaccine Friday, 02Apr2021, she had the positive result on Sunday, 04Apr2021, but that Friday night, 02Apr2021, she had body aches in her legs only but she walked a lot. She felt tired and her legs had muscle pain (onset date unknown). She felt tired currently and that was the only thing. What she had wasn't chills, but it was weird she has never felt that kind of chill before, it was inside the muscles. It was weird. It was different. The next day she called the doctor and he told her that she was positive for COVID and then her symptoms started the night before that and he said to take some medicine and that is it. She took it and the second day she was perfect. Caller confirmed that it was either Tuesday, 06Apr2021, or Wednesday, 07Apr2021, that she felt better. She confirmed that she has recovered completely from the body aches. She cough likes (she gave an example of the cough) and that is it. Probed if she still has the cough currently and she said that she did not have it at the date of report. The only thing was that if she had to clean the house or exercise, she can feel a little bit tired and then she has to rest. No further details provided. The only thing was the day she got the first symptom her period appeared and it was different because she had a lot of pain and in all of her life she has never gotten pain. She had a lot, a lot of pain in her pelvic area and it was in the coccyx area. It was a discomfort pain, it was weird. The first day of the period with the pain was 08Apr2021. Probed for how long she had the pain and she said it was the day before her period, the day of her period and then it disappeared the next day. It was really weird pain but she supposed it was because she had COVID. Confirmed began on 07Apr2021 and it went away on 09Apr2021 which was the day after. She has recovered completely. She had a COVID test on 04Apr2021 and had a repeat test on 05Apr2021 and both were positive. Someone said to repeat the test because she had the vaccine on that Friday and maybe she had a false positive and she thought about how her daughter didn't get the COVID vaccine and she was positive so the caller thought that she has to be positive too. And that is it, she repeated it at the convention center and she received the positive result again. Someone said that she needed to retest in 19 days, she asked if it was correct. For question if any AE(s) require a visit to: emergency room or physician office, the patient said yes (as reported), she had an over the phone appointment with her doctor because she got the positive COVID result and she wanted to ask him about what happened to her body. She had the vaccine and then had COVID with no symptoms inside her body. She said what happened? And someone she spoke to said that she would have to call her doctor because they didn't know. Nothing happened and the doctor said that she could get COVID without the vaccine because she didn't have enough time to protect her body. If she had gotten COVID after the vaccine, about 10 days then she would feel less. The outcome of events "a little pain after the vaccine and she could feel it in her muscle/her legs had muscle pain", "just had one or two days of body aches/body aches in her legs only" was recovered in Apr2021, "her period appeared and it was different because she had a lot of pain and in all of her life she has never gotten pain", "pain in her pelvic area and it was in the coccyx area", " was recovered on 09Apr2021, the outcome of other events was unknown.
47 2021-04-30 feeling hot Attendee received vaccination at about 04:30 and was sitting in observation area. At 4:43, attendee ... Read more
Attendee received vaccination at about 04:30 and was sitting in observation area. At 4:43, attendee waved to observer that she was feeling like she was going to throw up. Several staff members assisted attendee. EMT present on site and were summoned and were at attendees side within 1-2 minutes. Attendee having dry heaves, coughing, c/o of feeling hot. Vital signs at 4:45pm--temp 98.2F, pulse 112, resp 20, blood pressure 135/92, O2 sats 99-100% on RA with mild scattered wheezing. EMT continued with evaluation of attendee and moved attendee to ambulance, started at IV and administered 50mg Benadryl IV, and albuterol 2.5ml inhalation x2. Attendee then transported at approximately 5:00pm to Hospital and presented to waiting room ED. EMT reported attendee left in waiting room in good condition and waiting to see dr. At 5/1/2021, 11:38am, this writer called attendee to check on her status, left message to please return call.
47 2021-04-30 flushing, feeling hot Patient stated that her face was warm and flush and that she reacted the same way when she got stero... Read more
Patient stated that her face was warm and flush and that she reacted the same way when she got steroid injection. Took vitals at 11:54 am heart rate 73 o2 97, BP 108/79, again at 11:59 heart rate 79, o2 97, resp. 20 , BP 111/78, again at 12:04 am heart rate 81, o2 97, resp. 20 and BP 113/79. Patient was feeling better and was released with other.
47 2021-04-30 numbness Left side numbness from face to lower extremity of vaccine arm. EMT noted no facial drooping, and re... Read more
Left side numbness from face to lower extremity of vaccine arm. EMT noted no facial drooping, and reported symmetry. Patient reported as very anxious with uncontrolled HTN and anxiety. Pt with history of Bell's Palsy, denies SOB or lip/tongue swelling. EKG WNL. Transported per patient request. See chronic conditions section for list of existing conditions.
47 2021-04-30 pain in extremity 1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - ... Read more
1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - duration 2 days) headache, body ache, sore jaw, swollen chest and armpits, gastroinestinal issues, achey joints 2 weeks to the day after 2nd shot: sore, swollen, tender breasts and armpits; next day: mammogram resulting in injury to swollen lymph nodes that were an unknown reaction to the vaccine. It has been over a week now, and doctors are telling me this is going to be a process. I have been to the ER, and have had multiple tests ordered for imaging, but I am awaiting pre-authorization from insurance company. I am a teacher and doubt I will be physically able to return to work this school year.
47 2021-05-01 numbness, tingling Swelling underneath arm, on top of right collarbone, numbness and swelling along right arm, swollen ... Read more
Swelling underneath arm, on top of right collarbone, numbness and swelling along right arm, swollen fingers and tingling sensation on right hand
47 2021-05-01 pain in extremity After 24 hours of vaccination a lot of pain in the arm, fever and muscle pain in all body. After 48... Read more
After 24 hours of vaccination a lot of pain in the arm, fever and muscle pain in all body. After 48 hours of vaccination in addition of pain in the arm, I have a lot of itching and warm the area of vaccination in the arm.
47 2021-05-01 tremor, pain in extremity, cold extremities, tingling Initially felt dizzy for about 2 hours. Pain in left arm where given up into neck and pins needles i... Read more
Initially felt dizzy for about 2 hours. Pain in left arm where given up into neck and pins needles in left hand. All got better as day went on. Sore arm continued . Both eyes dry , burning, watery all day Saturday. Acted normal, busy day. All day excess saliva, spitting, metal taste in mouth. Stronger effects started sat night 5/1/21 1030 pm . Shakes, pulse very high, arms legs feel like bricks attached. Stomach nauseous acid reflux . I feel like there?s war inside my body. Fingertips to toes buzzing with this something inside me. Eyes burning dry. Tongue swollen, no appetite, metal taste in mouth .No headache. Cannot sleep, like a constant panic attack feeling. All muscles hurt. Dizzy again.fingers ice cold, skin burning hot to touch . No fever. Pulse ox normal /95 . Worst I?ve ever felt in my life. Exhausted, but feel like I?m going 1000 mph. Pins needles in feet. Bumpy rash started on arm (not at injection site)
47 2021-05-01 unresponsive to stimuli Patient was anxious upon recieving the vaccine. About 5 minutes after the shot patient became sweaty... Read more
Patient was anxious upon recieving the vaccine. About 5 minutes after the shot patient became sweaty, confused, light-headed, and then experienced a loss of conciousness. I had her sit in the floor upon feeling light-headed, she then proceded to lay down and then passed out. We called 911 at that point. She was out for maybe 1 minute. When coming back to she had some forgetfullness. I dont think she remembered passing out. She refused to keep laying down and said she was fine then proceded to sit back in the chair. I was talking to her and she kept telling me she was fine but then she passed out again. This time was again for about a minute. She stayed seated in the chair with her head slumped and was unresponsive, and again was out for about 1 minute. After coming back this time she seemed completely fine. Was talking normal and kept telling me she felt much better. EMS arrived and she refused to have her any of her vitals checked and demanded that she leave. I tried to follow up with her that evening on the phone but couldnt get ahold of her.
47 2021-05-02 migraine with aura You only allowed me to put in one set of dates, but I had my two shots April 7th and April 28. Exac... Read more
You only allowed me to put in one set of dates, but I had my two shots April 7th and April 28. Exactly 3 days later (Saturday morning) at exactly the same time, I had a migraine aura -- something I have had before, but not for a long time.
47 2021-05-02 pain in extremity, migraine 1st shot sore arm 2nd shot sore arm, fever, chills, body ache, migraine
47 2021-05-02 pain in extremity About 2 weeks after receiving first dose of pfizer vaccine, patient complains to headaches which las... Read more
About 2 weeks after receiving first dose of pfizer vaccine, patient complains to headaches which lasted for a week and a strange leg pain lasted for 3 days.
47 2021-05-02 pain in extremity fatigue, arm soreness, severe chills, fever, headache, nauseous
47 2021-05-03 discomfort, feeling cold Day after second Pfizer vaccine in the am woke to bad hip pain and stiffness in the right arm from t... Read more
Day after second Pfizer vaccine in the am woke to bad hip pain and stiffness in the right arm from top of arm at shoulder to hands felt stiff feels inflamed though not visible and muscle pains .This arm stiffness and feeling is still l on going and it seems worse when I wake up in the am though I sleep on my back . The lower back muscle pain come sand goes but the pain in my hips around my back is on and off not sure if this is related to vaccine but the day after the vaccine it was so bad hard to walk then it seem to ease by nine pm that day . My arm stiffness is on going. I had swollen lymph nodes under my right arm that started the 16th April two days after the second vaccine lasted about a week or a few days past the week . Day after second vaccine I had very bad muscle pains an stiffness in my back hips especially and arm and even had slight jaw pain the right side .I felt cold starting around two pm that day on and off then around five pm to eight pm or nine pm had chills come and go those went by around nine pm that all stopped .
47 2021-05-03 discomfort On 5/4/2021, client approached EMT complaining of discomfort. Client was a 47 year old female alert ... Read more
On 5/4/2021, client approached EMT complaining of discomfort. Client was a 47 year old female alert and tracking with her eyes. Client had a chief complaint of general malaise. For the duration of the assessment and history taking, an interpreter assisted with translation. Client stated that after 15 minutes of her observation, she began to experience malaise as well as generalized pain behind her eye and in her throat. This is the client's second dose of the pfizer vaccine (Lot #EW0167 Exp 08/2021) and she has a history of an allergy to cephalexin and reglan. Client denied any reactions to the first dose of the vaccine. Assessment revealed no swelling, hives, discoloration, shortness of breath or other signs of anaphylaxis throughout the patient's body. Client complained of malaise but denied wanting to faint. Client complained of pain behind her eye and in her throat but had no excessive salivation or difficulty speaking. Client stated that she only had orange juice for breakfast this morning. Client's initial vitals at 1025 were 120/80 blood pressure, 80 heart rate, respirations 16, lung sounds clear bilaterally, alert and oriented to person, place, date and event, temperature 98 f and her skin was warm and normal. EMT present was unable to obtain an O2 sat due to client's fingernail paint. Client stated that the symptoms she complained of today did not resemble her allergic reaction to IV antibiotics. Client consented to remaining an additional 30 minutes and her vitals were monitored at 5 minute intervals. Client was provided with a snack and water and had no difficulty eating or swallowing during her extended observation. Client's vitals remained stable throughout her additional observation period and were as follows: 1030 - 116/76, pulse 80, respirations 16, 1035 - 116/76 blood pressure, 80 pulse, 16 respirations, 1040 - 116/76, 80 pulse, 16 respirations, 1045 - 118/76 blood pressure, 80 pulse, respirations 16, 1050 - 114/74 blood pressure, 80 pulse, 16 respirations, 1055 - 114/74, 80 pulse, respirations 16. Client did state she had slightly more energy after eating a snack and drinking water. However, she continued to state that her eye pain and throat pain was still present. Client was asked if she needed staff present to dial 911 but client refused stating she wanted to "see how she feels." Client was offered 50 mg of Benadryl but refused stating she would "take some when she gets home." Client was encouraged to contact her primary or seek out urgent care today if symptoms do not improve. Client was provided with all relevant information regarding the vaccine and possible side effects. Client departed borderview at 1057 stating she felt safe to drive and stating that her husband will be with her when she gets home. Client remained a total of 45 minutes with no anaphylaxis reaction.
47 2021-05-03 unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: About 5 minute... Read more
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: About 5 minutes after given the pfizer covid 19 injection the patient said she was dizzy so I instructed her to sit down on the floor. She then proceded to lay down and then became unresponsive for about 1 minute. We called 911 at this point. She regained concouisness and said she was fine and got back in the chair (against my advice). I sat with her and she kept saying she was fine, then her head slumped over in the chair and she was unresponsive again. EMS arrived and she refused treatment
47 2021-05-04 weakness fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spo... Read more
fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 05Apr2021 10:00 as single dose for covid-19 immunisation. Medical history included hypothyroidism, high cholesterol, allergies to penicillin and shell seafood. here were no concomitant medications. The patient previously took Percocet [oxycodone hydrochloride;paracetamol] and experienced allergies. The patient experienced fainted, weak, tired, itching, trouble breathing, face swelling and unstable vital signs on 05Apr2021 21:30. The patient was hospitalized. It was unknown if the patient received any treatment. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
47 2021-05-04 feeling hot, pain in extremity Sleeplessness, chills, feeling hot (but no fever), sore arm. Chills and feeling hot came and went fo... Read more
Sleeplessness, chills, feeling hot (but no fever), sore arm. Chills and feeling hot came and went for a little over 12 hours starting about 14 hours after vaccine.
47 2021-05-04 feeling hot Client replied, "warm feeling and lightheadedness 2 minutes after vaccination. EMS initiated care. ... Read more
Client replied, "warm feeling and lightheadedness 2 minutes after vaccination. EMS initiated care. BP 160/90, P 94, O2Sat 100%. Client states that 150/90 is her normal BP" Monitored for 40 minutes. Client stated that she "feels better". Encouraged to follow up with primary care provider (PCP) and emergency services if needed. Verbalized understanding.
47 2021-05-04 numbness numbness to the right of my face and body; numbness to the right of my face and body; This is a spon... Read more
numbness to the right of my face and body; numbness to the right of my face and body; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Batch/Lot Number: EN5318 via an unspecified route of administration in left arm on 28Jan2021 02:45 as single dose for covid-19 immunization. The patient was 47-years-old at the time of vaccination. The patient was not pregnant. Patient relevant medical history included prior to the vaccine about a month ago experienced the numbness in face and in body and currently consulting a neurologist. The patient's concomitant medications were not reported. Patient haven't taken other vaccine in four weeks and no other medications in two weeks. Patient have no known allergies. Patient was not tested to covid prior to vaccination and not tested post vaccination. On30Jan2021 at 19:00 the patient experienced numbness to the right of her face and body. AE resulted in emergency room/department or urgent care. No treatment taken for resulted adverse events. Outcome of the event was recovering. Information about Lot/Batch number is requested. Follow-up (08Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: [Query]: Dear Colleague, Please see attached which was submitted by you. Please kindly confirm the date you first aware of the info reported in the attached source, as this date was considered as PRD (Pfizer receipt date). This date provided as 01Feb2021 on the report, while the adverse event start date provided as 30Jan2021 [Response]: Yes, the adverse event occurred on 30Jan. Here's the lot #EN5318. Follow-up attempts are completed. No further information is expected.
47 2021-05-04 migraine with aura, flushing, feeling hot Severe headache; low grade fever; severe nausea; severe nausea and abdominal pain; severe to moderat... Read more
Severe headache; low grade fever; severe nausea; severe nausea and abdominal pain; severe to moderate body aches; severe to moderate body aches and bone achiness; extreme fatigue; soreness at injection site; mild dizziness; feeling as if I were to have a recurrence of Shingles; severe to moderate flushing; redness on face, neck, and trunk with feeling hot all over; redness on face, neck, and trunk with feeling hot all over; increased aurora migraines; SaO2 levels which dropped from my usual 98-99% to 92-94% with slight elevation in HR; SaO2 levels which dropped from my usual 98-99% to 92-94% with slight elevation in HR; This is a spontaneous report from a contactable health care professional (other HCP; patient herself). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3302; Expiration date was not reported), via unspecified route of administration in the right arm on 20Jan2021 14:15 (at the age of 47-years-old) at a single dose for covid-19 immunization at a nursing home/ Senior Living Facility. Medical history included early menopause on HRT at this time, aurora migraines with or without headache (migraine with aura), chronic anxiety and depression; all of which from an unknown date and unknown if ongoing. Medical history also included allergies with milk and color dyes. Concomitant medications included medroxyprogesterone, clonazepam, quetiapine, and estradiol (ESTRA); all were taken for an unspecified indication and start and stop dates were not reported. The patient previously took Cefalexin monohydrate (KEFLEX) and experienced drug allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Jan2021, the patient experienced severe headache, low grade fever, severe nausea and abdominal pain, severe to moderate body aches and bone achiness, extreme fatigue, soreness at injection site, mild dizziness, feeling as if she were to have a recurrence of Shingles, severe to moderate flushing and redness on face, neck, and trunk with feeling hot all over, increased aurora migraines (flushing, headache and mild fatigue were reported to be within 24 hours and onset of severe symptoms were reported to have begun the following day approximately 20 hours post second injection). The patient's oxygen saturation levels also dropped from her usual 98-99% to 92-94% and had slight elevation in heart rate on 21Jan2021. The patient's blood pressure was not checked. All severe to moderate symptoms were reported to have lasted for seven days post vaccination until 26Jan2021 and events fatigue and headache lasted for next two weeks. The patient was reported to have start feeling better around 02Feb2021. There were no issues with any other vaccines in her life. The patient never had mRNA vaccine before these two (first dose was reported to be uneventful). The events were reported as non-serious. No treatment or medical intervention was received for the events. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): inconclusive on 06Jan2021 and negative on 08Jan2021; and oxygen saturation: 92-94% on 21Jan2021. The outcome of the events severe nausea and abdominal pain, severe to moderate body aches and bone achiness and severe to moderate flushing and redness on face, neck, and trunk with feeling hot all over was recovered on 26Jan2021 (with the reported duration of 7 days); outcome of events: extreme fatigue and severe headache was also recovered on an unspecified date (which was reported to have lasted for the next 2 weeks); and outcome of events low grade fever, soreness at injection site, mild dizziness, feeling as if I were to have a recurrence of Shingles, increased aurora migraines and SaO2 levels which dropped from my usual 98-99% to 92-94% was recovering. No follow-up attempts are possible. No further information is expected.
47 2021-05-04 pain in extremity, facial paralysis Suddenly needing to clear throat consistently about every two minutes. Dizziness. Face turned red. ... Read more
Suddenly needing to clear throat consistently about every two minutes. Dizziness. Face turned red. Right eye lid droopy. The following day arm hurt, tired and woke up with a very very sore neck.
47 2021-05-04 tremor Chills, uncontrollable shacking, nausea, extreme fatigue, on and off headaches,
47 2021-05-04 unresponsive to stimuli My wife (age 47) died on 14Apr2021 of a sudden death. She was found at home unresponsive and pulsele... Read more
My wife (age 47) died on 14Apr2021 of a sudden death. She was found at home unresponsive and pulseless. Her medical history is non-contributory for a sudden cardiac death. A full autopsy is pending.
47 2021-05-05 migraine I felt light headed shortly after leaving or within the 1/2 hour after vaccine. Later that evening i... Read more
I felt light headed shortly after leaving or within the 1/2 hour after vaccine. Later that evening i had a migraine. The following day another migraine. It went away and Monday it returned. I began taking Aleve and it eventually stopped. The Thursday after vaccination (4/15/21) i woke up full of blood like a period however it was not time for my period and the bleeding went away early that morning. Every other day after that i was getting spotting and i am still getting it. At the same time the bleeding started, i was having knots in my stomach that made me have multiple bowel movements daily. Every thing i ate would send me to the bathroom a few hours later. I have chronic constipation and have bowel movements usually 2-3 times a week but this vaccine had me going 2- 3 times a day . This lasted from until a day before i was due for my 2nd vaccine. I had the second dose 4/30/2021 and had no issues until today when the stomach knots and multiple bowel movements resumed. I am hoping it's going to pass quickly since i had no issues from the second dose. It was the first dose that was awful for me
47 2021-05-06 pain in extremity Chills, fever over 102.5, body aches, joint pain, severe headache, nausea, whole body aches, pain an... Read more
Chills, fever over 102.5, body aches, joint pain, severe headache, nausea, whole body aches, pain and swelling in arm
47 2021-05-06 tingling Pt reported itching in throat and tingling on left side of face. tightness in face started. BP: 134... Read more
Pt reported itching in throat and tingling on left side of face. tightness in face started. BP: 134/77, HR 89. O2- 98%
47 2021-05-06 tremor, pain in extremity Fever, chills, body shakes, shortness of breath, headache, arm pain, nausea, exhaustion
47 2021-05-07 weakness Fever of 100.5-101, for 20 hours. Chills. Sore and swollen joints. Headache that lasted 12 hours. So... Read more
Fever of 100.5-101, for 20 hours. Chills. Sore and swollen joints. Headache that lasted 12 hours. Some burning in my chest. Very itchy, burning eyes that could not be relieved with eye drops. Fatigue, dizziness, and some disorientation. A week later I am still experiencing strong fatigue and weakness, and burning eyes that is not as bad but still bothersome.
47 2021-05-07 bell's palsy, facial paralysis Pt developed left facial droop and left arm weakness. Diagnosed with Bell's palsy
47 2021-05-07 feeling of body temperature change Got shot at 9am on 4/23/21. By 3pm, fever was 101. During the night, I think my fever must have h... Read more
Got shot at 9am on 4/23/21. By 3pm, fever was 101. During the night, I think my fever must have hit 104 at least with the worst headache I've ever had in my life. 4/24/21. Extreme headache. Fever/Chills, Nausea and vomiting 4/25-26. Continue slight fever and chills. Heart was fluttering. 4/23 to present day (5/8/21). Fatigue. Still feel slightly achy, some light lung pain, and hot/cold in the morning and evening hours. Have to take Tylenol several times a day to calm my immune system. I don't feel like I need to see a doctor at this point, but I still don't feel 100%. I'm am concerned about getting a 3rd Pfizer booster shot that may be required.
47 2021-05-07 seizure had seizures; she fell; she was sleeping a lot; fever; fatigue; This is a spontaneous report from a ... Read more
had seizures; she fell; she was sleeping a lot; fever; fatigue; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 at 12:00 (Lot Number: ER2613) (at the age of 47-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing ulcerative colitis. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6208) for COVID-19 immunization. The patient experienced fever and fatigue (on 12Apr2021) but then got better. On Monday 19Apr2021 she was sleeping a lot, she fell and then had seizures. The patient was taken to the emergency room and a CT scan was performed; she was there for 5-6 hours. The patient confirmed that she was not admitted to the hospital. The patient outcome of fever and fatigue was recovering, the outcome of the other events was unknown.
47 2021-05-09 burning sensation, tingling On Saturday, March 27, I felt a "tingling" in my scalp and in my left eyebrow. The tingling increas... Read more
On Saturday, March 27, I felt a "tingling" in my scalp and in my left eyebrow. The tingling increased and intensified in the next several days, and by Tuesday evening (March 30), I had a rash down my face from my hairline to just between my eyebrows. It tingled and felt the tingling changed to a burning/tingling/electric feeling. By Wednesday morning, the burning had started becoming stronger, when I went to Urgent Care at 7:30 before school to see a doctor. The physician's assistant at Urgent Care looked at my face and heard my symptoms and diagnosed me with shingles. She prescribed Tylenol with codeine and Valtrex (Sorry - I don't know the dosage. I had to take it for 7 days, and I finished it so I threw away the pill bottle). The Tylenol with codeine did NOTHING for the pain. It steadily got worse through the week (Wed-Sat) and the rash became blisters. By Friday afternoon, even though I was on the Valtrex, the shingles had spread and pretty much covered the scalp on the left side of my head and went down my left forehead into my eyelid area. I saw my ophthalmologist, and he checked my eye and determined it was NOT affecting my ocular nerve and prescribed erythromycin ointment (3.5 gm) to apply to the rash twice daily. On Saturday, the nerve pain was incredible, and I called Urgent Care to see if there was something else I could try. When I spoke to a doctor on the phone he prescribed Gabapentin (300 mg, three times daily). This is what I have been using ever since. The shingles blisters have gone away and the skin that's left is very red/tender. I continue to use the erythromycin ointment twice daily and gabapentin. I still have pain in my left eye and where the shingles are currently subsiding.
47 2021-05-09 tingling About 2 hours after receiving my first Pfizer Covid 19 vaccine, I started getting pins and needles i... Read more
About 2 hours after receiving my first Pfizer Covid 19 vaccine, I started getting pins and needles in my hands and feet, It was constant for about 72 hours, and then became off and on since then. It is not 2 1/2 weeks later and I still have the off and on pins and needles daily. I'm concerned about getting my second dose, as I am afraid the pins and needles will get worse. I'm also afraid the pins and needles won't go away. Other side effects were a fever the day after my vaccine, that lasted 24 hours. Headache for 4 days, and body aches for 2 days.
47 2021-05-10 pain in extremity Sore arm the next morning; Headache; Disorientation; general tiredness/fatigue; This is a spontaneou... Read more
Sore arm the next morning; Headache; Disorientation; general tiredness/fatigue; This is a spontaneous report from a contactable consumer (Patient). A 47-years-old female (non pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:00 (at the age of 47-years-old) (Batch/Lot number was not reported) as 1ST dose, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient did not have any known allergies and no allergies to medications, food, or other products. Concomitant medication (within 2 weeks of vaccination) included doxepin (DOXEPIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 03Mar2021 at 02:00PM, the patient experienced sore arm the next morning; general tiredness, sore arm the next day, headache, fatigue and disorientation. There was no treatment received for the adverse event. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
47 2021-05-11 weakness, tingling, paralysis, pain in extremity At five mins Began with dizziness, then rash then diff breathing. Emt called to store and during am... Read more
At five mins Began with dizziness, then rash then diff breathing. Emt called to store and during ambulance transport to emergency room, extremities grew tingly then numbe then contracted stiffly (they called it posturing) in ER became stiff and entirely paralyzed. Spiked fever. After unknown amount of time gradually loosened up, did not have full mobility for over four hours. Following day still weak and trouble walking, bad leg pain from when they were postured. Brain fog, trouble thinking of right words, off and on dizzy.
47 2021-05-11 pain in extremity, weakness, numbness, tingling I tested positive for COVID on Jan 21 2021. My symptoms were generally mild - loss of taste and smel... Read more
I tested positive for COVID on Jan 21 2021. My symptoms were generally mild - loss of taste and smell, fatigue, some chest tightness (seemed like allergies until the taste and smell disappearred). As of today, taste and smell are still not normal (anosmia shifted to parosmia). Immediately following both vaccinations, 'standard' reported side effects were very mild - mild arm pain, fatigue, but no fever, achiness, etc. However, about a week after the first vax, i started to descend into a neurological haze - brain fog, muscle weakness/nerve issues (particularly in the face (mouth/eyes), neck, hands (challenges with grasp, tingly/numbness), legs (heavy, less muscle control upon standing). In that week after the first
47 2021-05-11 speech disorder 4/14/2021 to 4/17/2021 headache, fever, dizzy, very tired and heart palpations. Getting better 4/18/... Read more
4/14/2021 to 4/17/2021 headache, fever, dizzy, very tired and heart palpations. Getting better 4/18/2021 just had some heart palpations till 4/24/2021. On 4/25/2021 around 5pm developed, tight chest, a lot of heart palpations, dizzy and very tired. Laid down and went to sleep around 6pm. On 4/26/2021 was still very tired at around 5am. Adv work would be late. Got in at 9am. Supervisor asked me around 11am if fine. Advised her very tired. She asked if on something, slurring my words. Seem to be getting better 4/27/2021 till 5/3/2021 around 1:30pm. chest tight, heart palpations and heart time breathing and got dizzy. Boss called ambulance. They checked heart and oxygen level ok. Took me to hospital they checked heart and oxygen level again and was fine. Took blood, xray and put me in room. Gave pain medicine 2x because I was in severe pain. 1st did not work. Said fine follow up with Dr. Did around 5/4/2021 11:30am and adv me after exam I have costritis and anxiety. Adv put ice pack on chest, take medicine given and will get better with time. Gave me Naproxen, and buspirin.
47 2021-05-12 numbness Facial Swelling (Eyes,Lips,cheeks), itching, swelling wheal, redness on face, chest, neck, arm pain ... Read more
Facial Swelling (Eyes,Lips,cheeks), itching, swelling wheal, redness on face, chest, neck, arm pain at injection site, period flowing hard(came early), arm numbness, feeling like something running up my neck, felt weird right after, throat swollen, headaches, and fatigue.
47 2021-05-12 seizure Patient received 2nd dose of COVID vaccine, stayed near pharmacy for 15-20 minutes, then left store.... Read more
Patient received 2nd dose of COVID vaccine, stayed near pharmacy for 15-20 minutes, then left store. She called saying she and her husband went to get lunch afterwards, she started not feeling well, they got up to leave, and she had seizure. They called EMS and was having tests done to confirm seizure. Patient came to store to inform us of adverse reaction.
47 2021-05-13 feeling cold, tingling, numbness arm of injection has tingling, numbness, cold
47 2021-05-13 numbness Face, Teeth, and lips went numb 15-30 min, felt numb flashes a few days after vaccine.
47 2021-05-13 tingling, numbness Patient reported that a few hours after the day of her COVID vaccine, she had numbness and tingling ... Read more
Patient reported that a few hours after the day of her COVID vaccine, she had numbness and tingling in her arm, which spread all over her body. She stated it felt like pins and needles and worsened with activity. She stated she sees a physical therapist and after some exercises it started to feel worse. She continues to have tingling all over her body at this time. The RN asked her to also inform her primary care doctor as he knows more about past history, surgeries, etc.
47 2021-05-14 facial pain, tingling, night sweats nasopharyngeal congestion; ear popping; feverish feeling; night sweats; sob sensation; throbbing in ... Read more
nasopharyngeal congestion; ear popping; feverish feeling; night sweats; sob sensation; throbbing in face, nose, throat, chest, and head; throbbing in face, nose, throat, chest, and head; throbbing in face, nose, throat, chest, and head; throbbing in face, nose, throat, chest, and head; throbbing in face, nose, throat, chest, and head; temperature instability 97-100F; joint pain; achy spine; heel cellulitis; paresthesias; This is a spontaneous report received from contactable physician ((patient) reported for herself). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: Ek9231, expiry date not reported), intramuscular, administered in left arm on 29Dec2020 12:00 (age at vaccination as 47 years old) as first dose, single for COVID-19 immunization. The patient had no medical history and no known allergies. The patient was not pregnant at the time of vaccination and of the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTIN BAMBINI), zinc chloride, vitamin c (ascorbic acid), vitamin D, and zinc; all taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 08:00 AM, day 1, heel cellulitis and paresthesias started. On day 4, 02Jan2021, nasopharyngeal congestion, ear popping, feverish feeling, night sweats, sob sensation, "throbbing in face, nose, throat, chest, and head", temperature instability 97-100F. On an unknown date in 2021, patient had joint pain, headaches, achy spine for 4 months. Currently, patient was on treatment for heel cellulitis, and have been out of work since vaccine. Patient's symptoms have waxed and waned and still present. The reported events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events reported, which included antibiotics for several times. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, has the patient been tested for COVID-19 which included PCR (nasal swab) on 12Jan2021 which was negative. The outcome of the events was not recovered.; Sender's Comments: The event cellulitis is likely intercurrent and is unrelated to suspect product BNT162B2.
47 2021-05-14 numbness within 10 minutes of injection, heart racing, vision vaded to black, face and left side numbness
47 2021-05-14 nerve pain, pain in extremity Shingles - presented first as nerve pain in right arm and then after 23 days a skin reaction of sore... Read more
Shingles - presented first as nerve pain in right arm and then after 23 days a skin reaction of sores/blisters appeared. Prescribed an anti-viral (acyclovir) and nerve pain reliever gabapentin
47 2021-05-14 pain in extremity ?Pfizer-BioNTech COVID-19 Vaccine EUA? swollen joints in both hands and feet fuzzy head feeling un... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? swollen joints in both hands and feet fuzzy head feeling unable to sleep 36 hrs after injection
47 2021-05-15 pain in extremity Over a week later, my arm is itchy, the area of the shit is warmer than the rest of my arm, and if I... Read more
Over a week later, my arm is itchy, the area of the shit is warmer than the rest of my arm, and if I press it, it?s mildly painful (uncomfortable). It?s not red or discolored at all.
47 2021-05-17 muscle twitching Facial twitching developed on the left cheek, under eye. Began three days after vaccine on 4/30/21 -... Read more
Facial twitching developed on the left cheek, under eye. Began three days after vaccine on 4/30/21 - continued intermittenly until 5/16/21. This developed after the entire lower jar, teeth and eustachian tubes became sore within 18 hours after vaccination. Pain and soreness stopped on 4/29/21. Pain and soreness at the injection site occurred at the same time as well as low grade (101.5) degree fever - both ended on 4/29/21.
47 2021-05-17 pain in extremity, muscle twitching, numbness, tingling inability to move my arm; Severe pain up to my neck and down my arm (just on the left/injection side... Read more
inability to move my arm; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; Severe pain up to my neck and down my arm (just on the left/injection side) Then tingling and numbness, then inability to move my arm with twitching muscles; This is a spontaneous report from a contactable consumer who reported for herself. A 47-year-old non-pregnant female patient received her first single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration in left arm on 11Apr2021 16:30 (lot number EW0153) at age of 47-year-old for COVID-19 immunization. The patient's medical history was not reported. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received Vicodin. The patient experienced "severe pain up to my neck and down my arm (just on the left/injection side) then tingling and numbness, then inability to move my arm with twitching muscles (neck pain)" on 13Apr2021 19:00, "I thought I was having a heart attack or a stroke" on 13Apr2021 19:00. On 13Apr2021 19:00, severe pain up to patient's neck and down her arm (just on the left/injection side). Then tingling and numbness, then inability to move her arm with twitching muscles. She thought she was having a heart attack or a stroke. It lasted for about a minute then it subsided. It happened again 20 minutes later and again the next day. No lasting effects that she noticed and had not returned. The patient did not receive treatment for the events. The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had her second dose on 02May2021. Information about batch no/lot no has been requested.
47 2021-05-17 pain in extremity Fever, chills, muscle and joint pain, pain in arm and underarm
47 2021-05-17 tingling pt reported "heart racing", SOB, tingling in her hands. Sent to the ED
47 2021-05-18 cold sweat Patient was told to stay in the area for at least 15 minutes after vaccination. She eventually came... Read more
Patient was told to stay in the area for at least 15 minutes after vaccination. She eventually came up to the counter and said she was feeling light headed and that she felt like her chest and neck were tight but she was not having trouble breathing. She was asked to remain seated and the pharmacist sat with her and discussed her symptoms. The patient felt clammy and reported tightness in her neck but no restriction to breathing. Patient was given benadyl as a precaution to try to minimize any possible allergic reaction and she remained in the lobby for roughly 45 minutes. After further discussion the patient felt like she was not improving but not getting any worse but agreed to have paramedics called to the scene for further assessment. Patient actually walked outside to the ambulance where she was taken over care by the paramedics.
47 2021-05-18 migraine Site: Pain at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Se... Read more
Site: Pain at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Period was unusually heavy and had lot of clots. Not normal for her-Severe, Additional Details: Pt had to get a Toradol shot for a migraine in the left arm 6-7 days after the shot in the left arm that was vaccinated. She ended up getting a red , ropey looking line starting from the injection site up her arm that also had knodules going up that line as well. So she thinks that the heavy period with a lot of clots was caused by the injection and that the phlebitis of the left arm was possibly from the shot as well because she has had other IVs in her arms before that did not cause reaction
47 2021-05-18 pain in extremity Injection site soreness, pain, left arm pain, both hips, hands, neck, shoulders, back, clavicle area... Read more
Injection site soreness, pain, left arm pain, both hips, hands, neck, shoulders, back, clavicle area pain, muscle pain all over body, joint pain all over, very fatigued, bad headache and just feel awful.
47 2021-05-18 pain in extremity After the second vaccine only there were the following symptoms: ? injection site pain ? tiredness ?... Read more
After the second vaccine only there were the following symptoms: ? injection site pain ? tiredness ? severe headache ? severe muscle pain ? chills ? severe joint pain ? fever (101F) ? nausea ? feeling unwell ? arm pain (first 10 hours) All symptoms stopped at 5 am on Sunday (in 30 hours after they'd started). No treatments were taken, except for fasting, water, and sleeping. Information about painkiller (ibuprofen or acetaminophen) was controversial and no painkiller was not taken, as I was scared to lose the effect of the vaccination.
47 2021-05-18 tingling Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling... Read more
Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling across face just above upper lip; face and neck turned red and swollen/ arms turned red under sleeves; face and neck turned red and swollen; dizzy; brain fog; Existing Tinnitus in left ear is louder; This is a spontaneous report from a contactable consumer reported for herself. This 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 15:15 (Batch/Lot Number: Unknown) as single dose (at 47 years old) for COVID-19 immunisation. Medical history included fibromyalgia from (previously diagnosed as Rheumatoid Arthritis). Concomitant medications included fenofibrate, escitalopram, hydrochlorothiazide, losartan potassium (LOSARTAN/HCT), herbal sup, all taken for an unspecified indication, start and stop date were not reported. The patient previously took monosodium glutamate and experienced allergy, hydroxychloroquine sulfate and experienced allergy. On 27Apr2021 15:15, the patient experienced anaphylaxis, vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen/ arms turned red under sleeves, dizzy, brain fog, existing tinnitus in left ear is louder, all with outcome of not recovered (as reported). Therapeutic measures were taken as a result of the events included Diphenhydramine, Epinephrine, Famotidine, Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that: "Sent to ER via ambulance: Diagnosed with Anaphylaxis. Vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen, arms turned red under sleeves, dizzy, brain fog. Existing Tinnitus in left ear is louder, and as of 04May2021, I still have the headache". Seriousness criteria of the events was reported as serious due to disability. The information on the Lot / Batch number has been requested.
47 2021-05-19 pain in extremity itching all over my body/itchy; fever of 98.5F; I can't even work; sore arm; feeling crappy; This is... Read more
itching all over my body/itchy; fever of 98.5F; I can't even work; sore arm; feeling crappy; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 47-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EP6955) via unknown route of administration on 27Mar2021 at left arm as a single dose for COVID-19 immunization. The patient medical history included ongoing Crohn's disease. Concomitant medications included certolizumab pegol (CIMZIA) as a SINGLE DOSE (2 shot Once a month) for Crohn's disease and other unknown products. Patient states that she received her 2nd dose of the vaccine on March 26. On Sunday she started itching. Patient took 2 Benadryl and it didn't help. Patient has taken cortisone and used topical Benadryl as well. Patient was itching all over her body on an unknown date in 2021, it started on the arm where I got the shot, but it's spreading." Had a fever of 98.5F on an unknown date in 2021. Patient know someone else with Crohn's who had a bad reaction to the Moderna COVID vaccine. Patient stated, "I had some of the expected Pfizer side effect but I was not expecting this thing to be this itchy. Patient was literally wanting to crawl out of my skin. Patient have been on Benadryl since Sunday when it started and it started Wednesday and patient can't even work on an unknown date in 2021 because she have to take so much Benadryl just to stop the itching and it knocks me out. Patient was taking over the counter Benadryl and topical Benadryl and Cortisone, I mean it's bad. When confirmed that consumer took the COVID shot, consumer stated, "Yes I took my second shot, I took it on Saturday. On an unknown date in 2021, patient got sore arm which was expected, she was feeling crappy but I was not expecting to have this severe itchiness." Patient have been itchy for 4 days now since Sunday. Patient sated, "Just document that I am getting itchiness, because the itchiness is bad and they really need to disclose that on their side effects." Confirmed that consumer took the vaccine for the prevention from COVID 19 vaccine. The therapeutic measures received for the event itching included Benadryl and Cortisone. The outcome of the events was unknown. No Follow-up attempts are needed. No further information is expected.
47 2021-05-19 pain in extremity Super tired; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 47-year... Read more
Super tired; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on 29Mar2021 as 1st dose, single for COVID-19 immunization. Medical history included ongoing outbreaks on lip (oral herpes) began having outbreaks on her lip when she was 39. The patient had a family history of Fib (atrial fibrillation) from an unknown date reported that her mother has a fib but it's not genetic. Concomitant medication included valaciclovir hydrochloride taken for oral herpes from an unspecified start date and ongoing. On 29Mar2021, the patient experienced sore arm for 2 days and on 30Mar2021 experienced super tired. The reporter considered the events as medically significant. The patient underwent lab tests and procedures which included covid-19 screening: negative and X-ray: normal both on Apr2021. The outcome of the event sore arm was recovered on 31Mar2021 while for the event super tired was recovered on 30Mar2021.
47 2021-05-19 tension headache Started feeling "brain fog" a few days after second dose. It has been over a month and the fog has c... Read more
Started feeling "brain fog" a few days after second dose. It has been over a month and the fog has continued to be an issue. I struggle with memory loss and staying focused. The memory loss is very significant -- I will be working on a task and in the middle of it, forget why I am doing what I am doing. This causes extreme fatigue and thus stress headaches. In addition, my temper has become very short and I am quick to anger -- which is very unlike me. These symptoms are not getting better but are instead worsening. At this time I have not reached out for medical attention because I am unsure of how they would be able to help these symptoms. I fear if the symptoms do not relieve themselves or continue, I will be unable to perform my required daily tasks both at work and at home.
47 2021-05-20 migraine Migraine headache, fatigue, menorrhagia, dysmenorrhea, decreased concentration
47 2021-05-21 weakness dizziness, headache, weakness, fatigue. Three days later, I am still dizzy and have a headache.
47 2021-05-21 numbness Slight pain in right back of throat; Looked like Marge Simpson, felt like Novocaine numbing; Hives o... Read more
Slight pain in right back of throat; Looked like Marge Simpson, felt like Novocaine numbing; Hives on arms, legs, thighs, hips with lots of itching; Hives on arms, legs, thighs, hips with lots of itching; Nose and Upper Lip Angioedema; Right Eye puffy, closed, puckered, creased; Right Eye puffy, closed, puckered, creased; Right Eye puffy, closed, puckered, creased; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:15 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included seasonal allergies to pollen, grasses, weeds. The patient's concomitant medications were not reported. On 26Apr2021, the patient experienced right eye puffy, closed, puckered, creased, on 01May2021, nose and upper lip angioedema, felt like Novocaine numbing; hives on arms, legs, thighs, hips with lots of itching, on 04May2021, lower Lip Angioedema on right side, looked like an asymmetrical fat lip; continued Hives on arms, legs, thighs, hips with lots of itching, on 07May2021, left eye puffy, closed, puckered, creased; continued hives on arms, legs, thighs, hips with lots of itching. slight pain in right back of throat. The patient did not receive any treatment for events. The outcome of events was recovering. Information on lot/batch number has requested.
47 2021-05-22 feeling hot 2-3 minutes after patient received 2nd dose of Pfizer covid-19 vaccine, patient experienced these sy... Read more
2-3 minutes after patient received 2nd dose of Pfizer covid-19 vaccine, patient experienced these symptoms: warmth, feeling faint, dizziness, blurry/cloudy vision, chills. Patient lied down on the floor and called 911. Took patient's blood pressure: 137/90. Continued to monitor patient for ~40 minutes until husband came to pick her up. Patient felt better after lying down and was able to sit up right, ate chips and drank water. Patient did not have any water or meals prior to getting the shot, Firemen came to check-up on her. Took her blood pressure reading ~15 minutes before she left: 157/90. Counseled patient and husband on: serious adverse symptoms to lookout for and seek medical attention, to continue to closely monitor her symptoms and condition, and to contact her healthcare provider if she experiences flu-like symptoms. Provided Pfizer VIS.
47 2021-05-22 numbness, flushing Flushing, ear swelling, facial numbness
47 2021-05-22 pain in extremity I received the vaccine without incident on the 19th. I began to feel fatigued and sore arm at the v... Read more
I received the vaccine without incident on the 19th. I began to feel fatigued and sore arm at the vaccine on Thursday into Friday. I skipped the gym due to fatigue and arm discomfort (figured normal). Slept 12 + hours Thursday night, Friday night and Saturday night. Sunday morning still very fatigued and tired. Noticed my Garmin fitbit shows heart rate down to 50. Not sure if the low heart rate and fatigue are related. I had to rest after watering lawn yesterday and Friday (not normal for me) and chocked it up to fatigue. However I had to sit down while preparing homemade spaghetti sauce and meatballs in the kitchen this morning (also not normal) and with conversation on phone winded /cough when talking (also not normal). I have had tachycardia related to medicine in the past and stopped (antibiotic and cymbalta), never had a low heart rate. Wanted to report to help others if any correlation. Have concerns about receiving the second dose of vaccine. Years ago, 1992 I received the Hepatitis B Vaccine for nursing school and first shot was fine, second shot had severe fatigue and immunity levels were checked --was told at that time to not receive the 3rd dose as my levels were off the chart (immune response level). Not sure if there's a similar test to check this before receiving the 2nd dose. Thank you.
47 2021-05-23 slurring Patient mild, transitory speech slurring post-Pfizer #2, per EMS. She indicated no known allergies. ... Read more
Patient mild, transitory speech slurring post-Pfizer #2, per EMS. She indicated no known allergies. Per EMS hx of HTGN, "unknown cardiac" and "unknown neuro" conditions. BP 137/77; HR 78, RR 18, PSO2 98% per EMS report. Four lead EKG uneventful. She declined EMS transport. She was counseled by staff to discuss the reaction with her doct..
47 2021-05-23 numbness Pfizer-BioNTech COVID-19 Vaccine EUA Right hand was numbed (rated 2 on a 10-point scale). Right ar... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Right hand was numbed (rated 2 on a 10-point scale). Right arm was fine, only felt numbed in the hand. The symptom occurred almost immediately and lasted for about 10 hours.
47 2021-05-23 pain in extremity Had normal side effects (pain in the arm, tired, joint pain, muscle soreness, chills, headache). The... Read more
Had normal side effects (pain in the arm, tired, joint pain, muscle soreness, chills, headache). The more adverse symptoms occurred later in the evening the same day -- rapid heart beat, hard to breathe, diarrhea, nausea. Extreme exhaustion for ~24-48 hours after the adverse event evening symptoms. Also experienced blurry vision for more than a few days after receiving the vaccine.
47 2021-05-23 pain in extremity Dizziness - pharmacy technician did not give me the option to wait - it was not offered or recommend... Read more
Dizziness - pharmacy technician did not give me the option to wait - it was not offered or recommended. Immediately after the vaccination was given, I was free to go. I had a few things to pick up in the store and as I was headed up the aisle to the checkout, I immediately became dizzy and had to hold on to the shelf to keep myself upright. As I approached the counter, I noticed the pharmacy staff was heading out on break. I stopped one of the reps and explained that I didn't feel well and asked if I should go and sit down until the dizziness subsided. She replied yes and explained that they were on lunch but the pharmacist may come out. As I head back to the rear of the store, I continued to feel dizzy. The pharmacist was coming from the back (an office outside of the pharmacy) to accept a delivery and I explained that I was dizzy and was going to sit down. He shook his head yes, but never came back to check on me. I waited approximately 20 -25 minutes then left the store. *After talking with relatives and friends, all of them were required to wait at least 15 minutes before becoming mobile. Perhaps this option wasn't given to me since it was close to the time when the pharmacy closes for lunch. Later that day, my left leg began to hurt near my calf and it was extremely difficult for me to walk. I googled the side-effects and read that muscle cramps were possible, so I did not seek further medical attention. The pain was intense but had resolved by Saturday morning.
47 2021-05-23 tingling Could not breathe for 2 hours after 12 hours of getting the vaccine. Extreme tingling in bones. Espe... Read more
Could not breathe for 2 hours after 12 hours of getting the vaccine. Extreme tingling in bones. Especially both wrists.
47 2021-05-23 cold extremities, numbness 5/24/21 53 years old female with past medical history of cardiopathy (murmur) presents with numbness... Read more
5/24/21 53 years old female with past medical history of cardiopathy (murmur) presents with numbness to the right arm and leg post vaccination. Patient 12 lead EKG shows some PVC?s. Patient is hypertensive. Vital sign 175/89, 82 HR, 95%, 18 respiration rate, blood sugar is 88. Patient right fingers are very cold and are turning blue. Patient received second dose of Pfizer. Patient denies any reactions to previous vaccinations. Patient denies any chest pain and palpitations. NP and Paramedic by the stretcher monitoring patient. Vitals sign rechecked 163/103, 86, 95%, 19. Patient is still hypertensive. Patient denies any history of HTN. Rescue transported patient to hospital.
47 2021-05-24 grand mal seizure Patient was described as having a "Grand mal" seizure within 15 minutes of vaccination. Patient was... Read more
Patient was described as having a "Grand mal" seizure within 15 minutes of vaccination. Patient was observed, refused transport to ER, and was released to home when she felt better.
47 2021-05-24 numbness, tingling PT REPORTED OF NUMBNESS AND TINGLING OF THE LEFT ARM AFTER VACCINATION, DENIES SOB, DYSPNEA, HIVES O... Read more
PT REPORTED OF NUMBNESS AND TINGLING OF THE LEFT ARM AFTER VACCINATION, DENIES SOB, DYSPNEA, HIVES OR ITCHINESS, PT INSTRUCTED TO KEEPMOVING THE ARM TO HELP WITH THE SYMPTOMS AND EDUCATED THAT MAY EXPANDE MORE SIDE EFFECTS AS THE IMMUNE SYSTEM IS MORE RESPONCE TO 2ND DOSE. ALSO EDUCATED TO STAY HYDRATED, PT INSTRUCTED TO FINISH OUT 30 MIN OF OBSERVATION TIME AND TO NOTIFY TEAM IF SYMPTOMS WORSEN.
47 2021-05-24 numbness, tingling 3 Days after my 2nd shot on 5/8/21, I was woken up by numbness on both my feet and side of lower leg... Read more
3 Days after my 2nd shot on 5/8/21, I was woken up by numbness on both my feet and side of lower legs, more on the left than right. The numbness then work its way further up the side of my legs. It stays with the same degree of numbness for at least 2 hrs, but slowly improved after the 3rd hr, but it didn't go away until 6 hrs after it started. Even after the numbness subsided for the most part, I still have tingling feeling on my legs and feet. The next day (4 days after 2nd shot), I started feeling tingling on my hands and along side of my arms. Currently it's been over 2 wks, tingling has lessen in the last 2 days, but got a little worse again today, especially on left feet. Symptoms of tingling persisted and haven't gone away yet.
47 2021-05-24 tingling Patient started to not feel well almost immediately after the vaccine was given per certified pharma... Read more
Patient started to not feel well almost immediately after the vaccine was given per certified pharmacy technician on 5/22/21 around 4:05 P.M. Patient started to experience symptoms not related to anaphylaxis, but more so related to hypotension and/or anxiety. Symptoms include dizziness, body fatigue, pins/needles throughout her body, and also patient started to "see dark spots" when she had her eyes open. No other immediate symptoms were present. Patient's condition improved over time and was able to get up from the chair by herself approximately 15-20 minutes post injection. Patient initially had a normal body temperature of 98.6 F. Temperature was taken every 5 minutes starting from 4:11 P.M for a total of 5 readings, which gradually increased to 100.5 F. Patient's condition started to worsen approximately 30 minutes post injection after improvement and looked like she was going to become unconscious. Ambulance was called due to worsening of symptoms again, and patient's care was transferred over at around 4:45 P.M. Patient was called on 5/25/21 at around 2:40 P.M. for follow-up. Patient has not fully recovered, but is on her way to recovery. Currently, her only symptoms are feelings of pins/needles throughout her body while all other symptoms are gone. Advised patient to follow-up with physician for her current symptom. Patient acknowledged and will see doctor soon. No date was given.
47 2021-05-25 weakness After first dose her mental status become slightly altered and she leaned to the left a bit when sta... Read more
After first dose her mental status become slightly altered and she leaned to the left a bit when standing up and walking.. From the day of second dose my sisters appetite decreased. She started sleeping more, got weaker to the point I had to bathe her, she had to start using a wheelchair. Mental status much more altered. She was to weak to go to dialysis on Monday March 22 2021 hospice was called in Tuesday March 23 2021 and she passed away at approximately 4:00 P.M. March 24th 2021.
47 2021-05-25 feeling cold Severely tired, achy, freezing cold and nauseous with headache
47 2021-05-25 feeling hot About ten minutes after receiving a pfizer covid vaccine, pt stated that she felt hot and dizzy. I g... Read more
About ten minutes after receiving a pfizer covid vaccine, pt stated that she felt hot and dizzy. I gave her a cold pack to put on her neck. I helped her raise her feet to a chair and stood beside her. I then checked her blood pressure and it was low. she immediately said she felt better after placing the cold pack on her neck. she was responsive through the entire reaction. I monitored her blood pressure and pulse for 30 minutes and it gradually returned to normal. she sat out front with her friend for about 30 more minutes and i checked on her several times. she said she felt fine and left with her husband and friend. called pt later in the day (6pm) and she said she was feeling fine and had worked all day. Event Details
47 2021-05-25 migraine Moderate fatigue (greater than 36 hours); Muscle aches on left side of neck; Migraine-like headache ... Read more
Moderate fatigue (greater than 36 hours); Muscle aches on left side of neck; Migraine-like headache (great than 36 hours); This is a spontaneous report from a contactable pharmacist. A 47-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: EN6208) via unspecified route of administration in the left arm, as a single dose on 14Mar2021 at 15:15 (at the age of 47-years-old) for COVID-19 immunisation. The patients medical history included migraines, depression and anxiety. The patient was allergic to erythromycin. Concomitant medications included Prozac, Claritin, Alprazolam and glucosamine taken within two weeks of vaccination for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. On 14Mar2021, the patient developed migraine-like headache (greater than 36 hours), muscle aches on left side of neck (injection in left arm) and moderate fatigue (greater than 36 hours). The patient received Motrin as treatment for the adverse events. The clinical outcome of the events migraine-like headache, muscle aches on left side of neck and fatigue was resolving at the time of report. Action taken with BNT162B2 was not applicable No follow-up attempts are needed. No further information is expected.
47 2021-05-25 migraine Pt said after first dose lymph under arm felt swollen and experienced swelling. After receiving 2nd ... Read more
Pt said after first dose lymph under arm felt swollen and experienced swelling. After receiving 2nd dose 2 weeks later she said her lymph system "blew up". She was in immense pain, had fluid retention and developed fluid blisters, experienced vision impairment and oil glands clogged in eyes, migraines, hair is falling out and fatigue. Patient said doctor gave her high dose steroids. She is still being treated by doctor for this. Still having multiple symptoms and trying to get them under control.
47 2021-05-25 tingling Severely tired and achy and at injection site it was raised and enflamed and was extremely sore. By ... Read more
Severely tired and achy and at injection site it was raised and enflamed and was extremely sore. By afternoon I started to get pins and needles up both arms from fingertips up arm thru my shoulders and up both sides of my neck. They also were throbbing with pain and hurt if someone was to grab my arms.
47 2021-05-25 tremor 4/11 - I WOKE UP IN THE MIDDLE OF THE NIGHT WITH MY BPM'S HITTING 125, THE EPISODE LASTED 10 - 15 MI... Read more
4/11 - I WOKE UP IN THE MIDDLE OF THE NIGHT WITH MY BPM'S HITTING 125, THE EPISODE LASTED 10 - 15 MINUTES. 4/27 - I WOKE UP IN THE MIDDLE OF THE NIGHT WITH MY BPM'S REACHING 133 FOR 10-15 MINUTES. 5/14 - I WOKE IN THE MIDDLE OF THE NIGHT WITH MY BPMS HITTING 122 LAST 10 -1 5 MINUTES,, THIS LAST TIME I HAD UNCONTROLLABLE SHAKING. I WENT TO THE ER ON THE 2ND EPISODE AND THEY HAD NO FINDINGS. I HAD A BAD EKG WITH ABNORMAL T WAVES AND PROLONGED QT'S. PREVIOUS EKG'S HAVE BEEN FINE. I HAD ANOTHER EKG IN THE DR'S OFFICE AND THE PROLONGED QT'S WERE NOT PRESENT BUT I STILL HAD THE TWAVE ABNORMALTY. XIO PATCH SHOWS NOTHING SIGNIFICANT AND I ALSO HAD AN ECHOCARDIOGRAM THAT CAME BACK GOOD.
47 2021-05-26 bell's palsy Bell's Palsy
47 2021-05-26 flushing Patient C/o throat itching, flushing, and warmth to R ear. Water and PO liquid Benadryl given with ... Read more
Patient C/o throat itching, flushing, and warmth to R ear. Water and PO liquid Benadryl given with improvement. Disposition to home.
47 2021-05-26 hot flush The night of the vaccine, I began having hot flashes through the night. I didn't worry about it beca... Read more
The night of the vaccine, I began having hot flashes through the night. I didn't worry about it because I assumed it was normal. What does not seem normal is the fact that the hot flashes have continued. I'm now more than 3 weeks post vaccination, and each night I have multiple hot flashes all night long. I did not have any hot flashes before this vaccine.
47 2021-05-26 migraine, numbness In a little more than 24 hrs after the injection I began to have mild Migraine, and strange feeling ... Read more
In a little more than 24 hrs after the injection I began to have mild Migraine, and strange feeling as if I am coming down with a cold which subsided after taking Motrin. Then later in the evening my right leg from knee to my foot began to feel numb with a desensitization feeling. I took a hot shower, massaged the leg, the feeling did not go away. I have began stretching moving about more, getting up and down walking. The feeling and desensitization only began after the injection, only in this one leg, and has not ceased. It was intermittent, as it was coming and going, it was happening in the evening, now it is happening all during the day, even as I type this note, I am experiencing this weird feeling, I am not sure what to call it, it's not total numbness, some kind of desensitization feeling. It's very weird and scares me. I am not sure if I should even get the second dose. feel like a guinea pig with this vaccine.
47 2021-05-26 muscle spasms, pain in extremity 102F fever, cramps legs, very heavy period, body pain, headache, arm hand pain, feet cramps, stomach... Read more
102F fever, cramps legs, very heavy period, body pain, headache, arm hand pain, feet cramps, stomach cramps
47 2021-05-26 tremor, feeling cold joint pain in one of her legs; muscle and joint pain in one of her legs; So tired; Difficulty to con... Read more
joint pain in one of her legs; muscle and joint pain in one of her legs; So tired; Difficulty to concentrate; Sweats/sweats a lot; Headache; always cold; shaking/her hands are shaking; always cold and shaking; Not feeling well; Her head is heavy; Feels chilly; This is a spontaneous report from a contactable consumer (Patient). A 47-years-old female patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution of injection, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in Arm Right on 30Jan2021 as 1st dose, single for covid-19 immunisation. Medical history included breast cancer from 2018 and ongoing. She has it in her neck, treatment is almost over. Radiation was over two years ago, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included tamoxifen (TAMOXIFEN) taken for breast cancer started almost two years ago. A low dose, she was started on 20mg, but had a very bad side effect, was reduced to 5mg.20mg: NDC, lot, expiry unknown. LEVOTHYROXINE taken for thyroid disorder was started about 15 years ago from an unspecified start date and ongoing. The patient experienced headache, always cold on 31Jan2021, muscle pain in one of her legs on 03Feb2021, shaking/her hands are shaking and always cold and shaking on 31Jan2021, joint pain in one of her legs, muscle and joint pain in one of her legs, so tired, difficulty to concentrate on 03Feb2021, sweats/sweats a lot on 31Jan2021, not feeling well on 2021, her head is heavy on 2021, feels chilly on 2021. Question: Patient experienced headache, chills, and body weakness after getting the 1st dose of PFIZER-BIONTECH COVID-19 VACCINE last 30Jan2021-She wants to know if it's normal to have these symptoms - Took Tylenol to manage headache - According to her she already reported the side effects to (name). Question: "Can I skip the 2nd shot if I can't bear the pain. Additional Context:Calling about COVID vaccine. Had it on Saturday, she was ok on Saturday, since Sunday afternoon, she had a very bad headache, and Sunday night she started shaking, when she sleeps, she sweats, it is so bad that she needs to change, she is all wet, always cold and shaking, and she has muscle and joint pain in one of her legs, she is so tired and shaking, her hands are shaking, she cannot hold anything, is having difficulty to concentrate, do her job, she is not feeling well. She doesn't know if she should have the second one, or hold on, will the second be worse. The patient received treatment for the event headache with Tylenol. The Reporter stated the events as Non serious. Outcome of the headache was recovered on 01Feb2021, always cold was unknown, , muscle pain in one of her legs was unknown, shaking/her hands are shaking was recovering, always cold and shaking was recovering, joint pain in one of her legs on was recovering, muscle and joint pain in one of her legs was recovering, so tired was not recovered, difficulty to concentrate was not recovered , sweats/sweats a lot was not recovered , not feeling well was unknown , her head is heavy was unknown , feels chilly was unknown. Follow-up (04Feb2021): This is a Follow-up spontaneous report from a contactable consumer. Follow-up attempts are completed. No further information is expected.
47 2021-05-27 weakness Headache; Coughing; Fatigue/Tiredness; she doesn't have energy; Bacterial globules in her lungs; Tes... Read more
Headache; Coughing; Fatigue/Tiredness; she doesn't have energy; Bacterial globules in her lungs; Tested positive for COVID; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer sponsored program. A 47-year-old female patient (sister) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 24Apr2021 (at the age of 47 years old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included obesity (most likely 200 lbs) and hives. Concomitant medication included unspecified steroids for hives problem. The reporter stated that her sister got her first Pfizer COVID vaccine on 24Apr2021 and about days later, her sister tested positive for COVID on 30Apr2021 and schedule the get the second dose on 15May2021 this month and wanted to know if the patient should get it. The patient still has tiredness and she doesn't have energy to make a call. The reporter did not know if her sister has taken Tylenol or anything. The reporter know that the patient had headache, bacterial globules in her lungs, fatigue, and coughing. The patient had lab test at her hospital where she works, she had one when tested negative and when she had second one tested positive on 30Apr2021. The patient had not yet recovered from fatigue/tiredness and she doesn't have energy, while outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
47 2021-05-27 weakness WHILE PATIENT WAS MONITORED POST VACCINATION , WITHIN 15 MIN, PATIENT FELT WEAK AND HAD VOMITING. ... Read more
WHILE PATIENT WAS MONITORED POST VACCINATION , WITHIN 15 MIN, PATIENT FELT WEAK AND HAD VOMITING. EMERGENCY RESPONDERS WAS CALLED , PATIENT WAS TRANSPORTED TO EMERGENCY ROOM. ACCORDING TO PATIENT SHE WAS TREATED WITH FLUID INJECTION AND STOMACH MEDICINE FOR NAUSEA AND VOMITING. AT THE ER, PHYSICAL CHECK UP AND BLOOD WORK WERE PERFORMED, NO ABNORMAL FINIDINGS. PATIENT WAS DISCHARGED TO HOME FEW HOURS LATER. HCP CALLED PATIENT NEXT MORNING FOR FOLLOW UP , PATIENT STATED SHE IS FINE NO SYMPTOMS OF WEAK/NAUSEA/VOMITING.
47 2021-05-27 burning sensation, tingling, cold extremities Hands and feet felt like the were on fire, swollen, and cold all at the same time. No fever present.... Read more
Hands and feet felt like the were on fire, swollen, and cold all at the same time. No fever present. Symptoms lasted 8 hours and since that date of onset, tingling in hands has been reoccurring at nighttime.
47 2021-05-27 discomfort About 15 min after the shot, I started to feel dizzy, but the BP was just little higher than my norm... Read more
About 15 min after the shot, I started to feel dizzy, but the BP was just little higher than my normal - 120-130/90 - 100 with pulse 70-88. No epi was administered and my husband (came with me due to my history of hypertensive anaphylactic reaction to an allergy shot) drove us home. By the time we got home, I was nauseated and my husband could see some fluid in my ear with an otoscope. He called an allergist office and the medrol pack was prescribed (also prescribed at the time of anaphylaxis previously). About 16 hours post-vaccine, I felt chills, then, low grade fever, headaches, bodyaches and heaviness/fatigue followed. Those symptoms came and went a few times. By 48 hours pose dose, all flu-like symptoms dissappeared.
47 2021-05-27 numbness "Tongue and cheek feel numb" Evaluated by EMS-Cleared
47 2021-05-27 nerve pain, numbness, tingling Left upper arm began feeling extreme pain radiating to shoulder neck and down to shoulder blade. A... Read more
Left upper arm began feeling extreme pain radiating to shoulder neck and down to shoulder blade. After several hours the pain increased to forearm, hand and into fingers. Fingers became tingling and numb. Pain so intense I went to hospital three days later. Was given gabapentin for nerve pain and arm put in a sling. That did nothing to resolve the pain. It is still very intense from the left shoulder blade over my left shoulder down my arm to my hand. It hurts worse when I bend over. I get minor relief when I hold my arm over my head. I cannot deal with this pain much longer. It is too intense.
47 2021-05-27 pain in extremity Very achy "vaccine" arm one week after second shot. Painful enough to wake me up in the middle of th... Read more
Very achy "vaccine" arm one week after second shot. Painful enough to wake me up in the middle of the night
47 2021-05-27 tremor Headache, stomachache, nausea, vomiting shakes/ tremors. Can't hold any food or drink down. Sympto... Read more
Headache, stomachache, nausea, vomiting shakes/ tremors. Can't hold any food or drink down. Symptoms lasting 4 days and counting.
47 2021-05-28 burning sensation pain/fatigue in neck and shoulders; sharp pains in the head, like a burning sensation; pain/fatigue ... Read more
pain/fatigue in neck and shoulders; sharp pains in the head, like a burning sensation; pain/fatigue in neck and shoulders; pain/fatigue in neck and shoulders; sharp pains in the head, like a burning sensation; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Feb2021, the patient experienced, the patient received first dose Pfizer on 16feb2021 4 days after the shot she developed sharp pains in the head, like a burning sensation, with pain/fatigue in neck and shoulders. Pain was still ongoing. The outcome of events headache, burning sensation, fatigue was unknown whereas pain was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
47 2021-05-28 numbness facial swelling( Eyes,Lips,Cheek); Itching; swelling wheal; redness on face/chest /neck; arm pain at... Read more
facial swelling( Eyes,Lips,Cheek); Itching; swelling wheal; redness on face/chest /neck; arm pain at injection site; menstrual period flowing hard (came early); menstrual period flowing hard (came early); arm numbness; feeling like something running up my neck; dizzy; throat swollen; headaches; felt weird right after; fatigue; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on left arm on 07May2021 12:45 (Batch/Lot Number: EW0169) as 1st dose, single dose (at the age of 47 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced facial swelling( Eyes,Lips,Cheek), Itching, swelling wheal, redness on face, chest, neck, arm pain at injection site, menstrual period flowing hard (came early), arm numbness, feeling like something running up my neck, dizzy, felt weird right after, throat swollen, headaches and fatigue on 07May2021. The patient received treatment: steriods/ stomach anticid, antihistamine. Prior to vaccination, patient was not diagnosed with COVID-19 and not been tested for COVID-19. The patient had emergency department visit. The outcome of the events was recovering.
47 2021-05-28 pain in extremity, tingling, numbness, nerve pain Shot was received in my left arm. Within 10 minutes of shot, had severe pain in arm. Nerve pain, p... Read more
Shot was received in my left arm. Within 10 minutes of shot, had severe pain in arm. Nerve pain, pins and needles, ran up and down my arm and hand. Hand and pinky finger had numb areas. Nurse came to waiting area and I asked if this was normal. She said some pain was ok. This was a lot of pain. Pain continued for a couple of days straight and then off and on. Pins and needles in hand never fully stopped. Also had facial numbness on left side of my face, chin and lower lip. Upset stomach continued for a couple of weeks. When I went for the second shot on May 27th, same nurse was there and asked about my pain. She was going to report it. The second shot was worse. The pain started again within 10 minutes. Within 30 minutes was unable to lift my arm to open the car door. Tried to go back to work but needed to take some time off to lay down and immobilize my arm. Pain was excruciating for hours. Still have pain as of today.
47 2021-05-28 tremor, involuntary muscle movements Tremor, dyskinesia, brain fog, tachycardia
47 2021-05-28 unresponsive to stimuli Systemic: Fainting / Unresponsive- Mild, Additional Details: Pt fainted a few minutes after injectio... Read more
Systemic: Fainting / Unresponsive- Mild, Additional Details: Pt fainted a few minutes after injection, but quickly came to and was responsive. Spouse stated pt had history of fainting after giving blood.
47 2021-05-30 throat numbness Acute onset, subjective throat tightness and numbness. Recurred with second dose. No treatment, vita... Read more
Acute onset, subjective throat tightness and numbness. Recurred with second dose. No treatment, vital signs stable.
47 2021-05-31 pain in extremity, burning sensation Really bad sore arm. Can't move arm all the way up without pain. Rash under the infection it is size... Read more
Really bad sore arm. Can't move arm all the way up without pain. Rash under the infection it is size of a baseball. Rash burns hurts an itching. It has been like this over 2 weeks now
47 2021-06-01 numbness 3 days after receiving my 2nd Covid shot I had sharp pains in my chest that progressed to constant p... Read more
3 days after receiving my 2nd Covid shot I had sharp pains in my chest that progressed to constant pressure. I went to Urgent Care when I also became light-headed and my left hand was going numb. They immediately did and EKG, which was abnormal, and sent me to the ER. I continued to have episodes of blood pressure and heart rate spiking with continuous chest pain. They did bloodwork, a chest X-ray, a CT scan of my lungs as well as 2 more EKG's. My bloodwork was elevated for heart enzymes and possible blood clot. 2 days later I was back in the ER for the same issues, 2 more abnormal EKG's and a chest X-ray. I saw a cardiologist 3 days later, he sent me to the ER right from his office and I had a cardiac catheterization later that same day. This whole time I'd been having chest pain and pressure, shortness of breath, fatigue, high blood pressure episodes. I was allowed to go home but have continued to have chest pain ever since with no explanation. I had bloodwork drawn again yesterday, now testing for myocarditis.
47 2021-06-01 tingling, numbness, seizure like phenomena PT CAME FOR 1ST COVID VACCINE DOSE ON 5/7/21. DEVELOPED PAIN / NERVE TINGLING AND HAD SEIZURE LIKE ... Read more
PT CAME FOR 1ST COVID VACCINE DOSE ON 5/7/21. DEVELOPED PAIN / NERVE TINGLING AND HAD SEIZURE LIKE ACTIVITY THAT NIGHT. LEFT SIDE WAS NUMB AND COULD NOT HEAR FROM LEFT EAR. RINGING IN EAR, EYE TWITCHING. ARTHRITIC-LIKE PAIN IN LEFT HANDS (NEVER ON RIGHT SIDE). HAS NOT BEEN TO ER BUT STILL AS EFFECTS ON 5/27/21. NEVER ANY PROBLEMS W OTHER VACCINES
47 2021-06-02 pain in extremity brusing around site; Swollen; Sore arm; This is a spontaneous report received from a contactable con... Read more
brusing around site; Swollen; Sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old non pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown), via an unspecified route of administration on the left arm on 16Mar2021 at 15:30 as single dose for COVID-19 Immunisation. Medical history was not reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient experienced sore arm, swollen and bruising around site on 16Mar2021. No therapeutic measures were taken for the adverse events. The clinical outcome of the events vaccination site bruising, vaccination site swelling and painful arm were recovering at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
47 2021-06-02 pain in extremity she started having pain in her leg and veins; She started having pain in her leg and veins; she can ... Read more
she started having pain in her leg and veins; She started having pain in her leg and veins; she can barely walk.; Vein in her leg that popped up; Barely able to move; This is a spontaneous report from a contactable consumer (patient's daughter). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0161), via an unspecified route of administration on 20May2021 at 14:00 as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that, yesterday, 4 days after her vaccination, she started having pain in her leg and veins in her thigh popped up. Today, she can barely walk. She mentioned that her mother had no health problems and had no complications before she got the vaccine. She also mentioned that she knew people that had common side effects like body aches after receiving the vaccine but her mother was different due to the vein issue. She was due for her 2nd dose on 10Jun2021 and would like to know if this has been reported with the vaccine. Reporter stated, Okay so my mom got the first shot of Pfizer vaccine. This be like you know because of vaccine because she did not have any problem before just right up she got the shot, she have that. Do you think this thing, is common for most of the people that got Pfizer. Reporter was informed about Pfizer and was provided with the number. Reporter stated, I report these to other representative couple minutes ago but right now I just need to know what we can do in this case. In this case you know for my mom. Should we go to the hospital. When informed about Pfizer . Reporter was informed to select option 3, after dialing the number and the timings as 8 AM to 8 PM from Monday to Friday and 9am to 3 pm from Saturday and Sunday as per EST. When requested for permission for further probing, reporter stated, I mean I did answer all of the questions, medical history for my mom, the age, the information of the vaccination card, I did give that all just right now, 2 minutes ago but I thought this was the medical option. Reporter was informed the timings again. Further information could not be probed as consumer was unwilling to complete the report. Hence, limited information available. Thus, product details (LOT, NDC, UPC and Expiration date) and pharmacy details could not be probed over the call. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
47 2021-06-02 tingling Symptoms: Experienced tingling and swelling of throat and tongue about 10 minutes after vaccine. Thi... Read more
Symptoms: Experienced tingling and swelling of throat and tongue about 10 minutes after vaccine. This is a reaction that has never occurred to me with any allergen. I have never needed an Epi-pen before and no allergy test has ever indicated that I have a severe allergy to anything. Treatment: Nurse administered an Epi-pen into left thigh and called 911. Transported to Emergency Department by ambulance. Received IV administration of Benadryl, a steroid, and an antihistamine. Was observed for about two hours and then released at about 3:30 and instructed to take Benadryl for the next 24 hours. Symptoms started to occur again in the ambulance (about 12:40 pm) and again at about 10:00 pm. Emergency Department treatment was after the 12:40 pm occurrence. Took oral Benadryl after the 10:00 pm occurrence. Outcome: I was fine by the next morning and experienced no other symptoms.
47 2021-06-03 burning sensation swelling of her tongue. She only has swelling to the left side of her tongue. Redness and burning ... Read more
swelling of her tongue. She only has swelling to the left side of her tongue. Redness and burning of her face and bilateral eye redness
47 2021-06-03 feeling hot, cold sweat had a very dry mouth; some swelled and itchy hives on the back of my legs; some swelled and itchy hi... Read more
had a very dry mouth; some swelled and itchy hives on the back of my legs; some swelled and itchy hives on the back of my legs; some swelled and itchy hives on the back of my legs; chills; I was getting sick; hot; clammy; This is a spontaneous report from a contactable consumer (Patient). A 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 6n6199 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 01Mar2021 15:45, as single dose for COVID-19 immunization. Patient's medical history included asthma, pneumonia, tuberculosis, whooping Cough and allergy to milk. Concomitant medications include Zyrtec, Magnesium, Calcium all taken for unspecified indications. The patient previously took vaccine for Pneumonia via an unspecified route of administration, administered in left arm, vaccine for tuberculosis and whooping cough via an unspecified route of administration, administered in right arm on 18Feb2021. The patient did not had COVID prior vaccination and was not COVID tested post vaccination. On 01Mar2021 08:00 pm, the patient started experiencing some swelled and itchy hives on back of legs, had very dry mouth since getting it (it's been 5 days). On an unknown date in Mar2021, the patient also began to feel like she was getting sick (but 5 days afterward), began to have chills, then hot and clammy. Therapeutic measures were taken as a result of chills, hot and clammy and patient was treated with Tylenol. The outcome of the events was reported as not resolved. No follow-up attempts are possible. No further information is expected.
47 2021-06-03 tingling D-EMS was dispatched to the COVID vaccine clinic for a pt whom received her vaccine and was now havi... Read more
D-EMS was dispatched to the COVID vaccine clinic for a pt whom received her vaccine and was now having a reaction to it. C-Allergic reaction to COVID vaccine. H-Pt had her first dose of the COVID vaccine at 1630 and was sitting in the evaluation line. She stated that she began breaking out into hives and called the paramedic. The pt began to feel tingly all over felt as if her mouth was swelling. Paramedic obtained a set of vital signs; placed her onto the 3lead monitor which revealed sinus tach and obtained IV access to administer 50mg of benadryl and 40 mg of pepcid PO. They called for Medic 6 to transport the pt to the ER. A- We found the pt sitting upright a&oX4 skin P/W/D. At the time of our arrival there was no more hives noted on the pt. The pt was nervous and stated that her lips and nose were tingling. She denied shortness of breath or trouble breathing but stated that it was hard for her to swallow. There was no noted swelling to the pts tongue. The pts lung sounds were clear and bilateral. The pt had already recieved a dose of benadryl and pepcid as previously stated. Rx-We obtained a baseline set of vital signs. Paramedic switched the pt from Paramedic 3lead to our own, which revealed sinus tach. We assisted the pt as she stood and sat onto the cot. We secured the pt to the cot per SOGs in the semi fowler position. We loaded the pt into the ambulance. T-We transported the pt routine traffic to TRH via Medic 6. While en route to TRH we continued to monitor the pts vital signs. The pt stated that it didnt feel like she was having trouble breathing but she felt as if she couldnt take a full deep breath. Lung sounds remained clear and bilateral with a o2 sat of 100% on room air. Paramedic administered 125mg of solu medrol. The pt remained stable. The pt denied any other new or worsening symptoms. Once we arrived at TRH we placed the pt into the ER bed in room 7 via 2 person sheet pull. Report was given to the RN. Medic 6 was cleaned and restocked and we returned to service. History of Present Illness This is a 47-year-old Caucasian female who presents to the emergency department by EMS due to symptoms resulting after receiving Pfizer COVID-19 vaccination today. It was her first shot. She developed some tingling in her lips as well as some difficulty swallowing. She did not have any respiratory difficulty. EMS gave her Pepcid, Benadryl, Solu-Medrol prior to arrival. Upon arrival she is still having some symptoms of difficulty swallowing. She is quite anxious. She states that she was feeling fine prior to the vaccination. Imported information including vital signs, nursing notes, allergies, past medical/social/family/surgical history reviewed Routine PPE including gloves if indicated, face mask, eye protection worn during the patient encounter ssessment: Possible adverse reaction to vaccine versus anxiety. Patient was initially seen by Dr. and had medical screening exam performed. He had ordered epinephrine and 0.5 mg of lorazepam. The patient remains tachycardic and states she feels like she is having problems swallowing. On exam there is no stridor. She is able to swallow her secretions. I do not appreciate any neck swelling. Chest is clear. No focal neurologic findings. EKG My EKG interpretation: Sinus tachycardia with a ventricular rate of 110. No acute ST elevation, T wave inversion, ST depression Reexamination/Reevaluation Reevaluation: Patient's potassium is 3.2. CO2 is 19. That is consistent with hyperventilation. Other labs are normal except for glucose of 229. Soft tissue neck x-ray was obtained and that showed some possible airway inflammation and therefore CT scan will be done to more effectively characterize the findings. Patient received potassium replacement as well as additional Ativan. She will also be given some IV fluids since she remains slightly tachycardic. That could be lingering effects of the epinephrine The patient's D-dimer was normal. She felt better after Antivert and Lopressor. Heart rate remained below 100 and but other vital signs were normal. Dizziness was better Diagnosis/Disposition Adverse reaction to vaccine Patient Instructions Drink plenty of fluids. Watch for worsening symptoms of difficulty swallowing, shortness of breath, facial swelling. Antivert for dizziness. Work note for tomorrow. Recheck with your doctor sometime within the next 3 weeks to see if you should get the second dose of the vaccine. Return to the emergency department if worse or new symptoms. RX Given meclizine: 1 tab, PO, TID, dizziness/motion sickness, # 20 tab, 0 Refil(s)
47 2021-06-03 tremor Tremors and full body pain that lasted about 12 hours. Low grade fever. Fatigue.
47 2021-06-03 unresponsive to stimuli became unresponsive, intubated in the field with CT images revealing a diffuse SAH, IVH, cerebral ed... Read more
became unresponsive, intubated in the field with CT images revealing a diffuse SAH, IVH, cerebral edema, brain compression, possible aspiration pneumonia o Admit to NICU s/o Doctor o Consult Doctor for CC o Neuro checks q1h o SBP < 110 o Mannitol 50g IV x1 stat than 3% HTS for NA goal 145-155 o EVD placement ASAP o Amicar 5g stat o COVID PCR negative o Labs/ medications as ordered o SAH protocol o Plan for cerebral angiogram and possible coiling in am with Doctor.
47 2021-06-04 pain in extremity Fever of 100.4 degree; I was not able to really sleep I kept waking up; feet hurting; Body aches; ha... Read more
Fever of 100.4 degree; I was not able to really sleep I kept waking up; feet hurting; Body aches; having a lot of phlegm in the back of my throat / coughing up a lot of phlegm; having a lot of phlegm in the back of my throat / coughing up a lot of phlegm; Back hurting; Pain in my joints in my arms and my elbow; Pain in my joints in my arms and my elbow; Pain in my joints in my arms and my elbow; I still have this 'throbbing' (not clarified further) in my big toe that will not go away like I'm like in extreme pain in my right foot in my big toe.; I feel like this is gout or something it's driving me crazy, because my big toe is hurting so bad; I'm like in extreme pain in my right foot in my big toe. But, the other issue that I was dealing with is the fact that, it was in my left foot and then it went to my right foot; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 47-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on an unspecified date around 2 O'clock in the afternoon (Batch/Lot Number: EN6206) as unknown, single dose for covid-19 immunisation. Medical history included multiple sclerosis. Concomitant medications included patient take medication for her thyroid and she also take an infusion for her multiple sclerosis. She also stated that she had blood work in the last 3 weeks in February 12th may be. On an unknown date when patient got home, she experienced a fever of 100.4 degree. She started drinking some water to bring the temperature down she took 3 Tylenol (as an event treatment) to bring the temperature down and I finally dropped the temperature down to 98.7. further, last night she did not have and she was not able to really sleep and kept waking up, she did not have chest pains or anything like that, but last night her feet started having issues as her feet hurting, her big toe was throbbing which she was not clarified and also had body aches. In morning, patient started having a lot of phlegm in the back of her throat, had coughing up a lot of phlegm. she took a Benadryl and, also took two more Tylenol, because she started having body aches again and Tylenol was not helping her alone because of lot of pain, her back hurting and started having pain in her joints, arms, and elbow. Patient still experienced throbbing (not clarified further) in her big toe that would not go away like in extreme pain in her right foot and in big toe. It was reported that patient had other issue that she was dealing with her left foot and then it went to her right foot which she did not understand why. The outcome of all events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
47 2021-06-05 unresponsive to stimuli In observation post vaccine within 15 minutes c/o tired and "loopy" and when being evaluated continu... Read more
In observation post vaccine within 15 minutes c/o tired and "loopy" and when being evaluated continued to have a drop in BP with and Increase in HR= became unresponsive and 911 called. NO resp issues or hives
47 2021-06-06 burning sensation, pain in extremity I got the 2nd shot on June 4th, woke up on June 5th with a red spot about the size of a quarter. Lat... Read more
I got the 2nd shot on June 4th, woke up on June 5th with a red spot about the size of a quarter. Later that afternoon, my left arm started hurting really bad along with my whole body. I called the after hour clinic, doctor told me to call back if it gets bigger. I called the next day (June 6) because it was about the size of a baseball. Doctor told me to take Benadryl and put Hydrocortizone cream on it. Today (June 7) it is the size of a softball. It burns and is itchy. It has made the whole top of my arm and the under arm hurt so bad.
47 2021-06-06 cold sweat Pt received covid vaccine from us, shot went fine no issues. Technician administered the shot. Abo... Read more
Pt received covid vaccine from us, shot went fine no issues. Technician administered the shot. About 5 minutes after pt became nauseous so I had her come into the health services room. Handed her garbage can if she needed it to vomit in. She ended up not needing it. She stated that she felt clammy so I gave her a cold compress. She used the compress. I asked pt if she felt itchy (hives) and she said no. I asked her if she had any unusual feeling in her heart beat and she said no. A few minutes later pt said she wanted to lay down on floor, I accomodated that. I asked pt throughout the process if she felt itchy (hives), or any other symptoms. Pt continued to say that they felt a little better and nausea was subsiding. Eventually pt's husband came and I let him into the room with the pt. After about 5 more minutes pt said they felt better and the couple left together. Pt thanked us for our assistance.
47 2021-06-06 feeling cold After the second Pfizer shot, I had no reactions until 12 hours later. After 12 hours (1am), I woke ... Read more
After the second Pfizer shot, I had no reactions until 12 hours later. After 12 hours (1am), I woke up and my skin/body was achy, which lasted about 24+ hours. I was tired and napped and slept 12 hours that next night. I didn't have a registered fever, but I was cold and had long sleeves/pants and blankets on me while it was hot outside (high 70's/low 80's). The one symptom that I don't hear about and scared me, was when I breathed normally, I didn't notice anything, . . . but when I tried to take deep breaths, it felt like there was an elephant sitting on my chest. This breathing difficulty started at about 30 hours after the second shot (8pm). By the morning time, it was a small elephant, and by 48 hours after the second shot, it seemed to be mostly gone. This one scared me while it was happening and I was praying hard! I felt the pressure on my chest like COVID patients, but thankfully, it only lasted a short time. I still haven't met someone who had the shortness of deep breath and chest pressure after the second Pfizer shot, like I did.
47 2021-06-06 fibromyalgia, migraine, pain in extremity Pt reported fatigue, headache, myalgias, and chills. Per appointment, pt is experiencing a fibromyal... Read more
Pt reported fatigue, headache, myalgias, and chills. Per appointment, pt is experiencing a fibromyalgia flare, has a migraine, and reports "burning pain on upper arms and lower extremities" to the point that she has been unable to wear clothing that touches her arms due to the pain.
47 2021-06-06 pain in extremity Headache and nausea at 3:00am on 04jun2021. No treatment given. Drank plenty of water throughout the... Read more
Headache and nausea at 3:00am on 04jun2021. No treatment given. Drank plenty of water throughout the day. Headache and nausea resolved approximately 8:00pm 04Jun2021. Left arm soreness at time of injection at injection site.
47 2021-06-07 weakness Pericarditis: inflammation of heart's lining; Stabbing pain shooting from upper-mid back through to ... Read more
Pericarditis: inflammation of heart's lining; Stabbing pain shooting from upper-mid back through to sternum; Fever; Overall weakness; Severe pain; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (lot number: EW0175), via an unspecified route of administration in arm left on 26Apr2021 15:30 at single dose for COVID-19 immunisation. Medical history included endometriosis, no recent issues. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included estradiol, progesterone, and paracetamol (TYLENOL). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pericarditis: inflammation of heart's lining, stabbing pain shooting from upper-mid back through to sternum, fever, overall weakness, and severe pain on 12May2021 10:00. Facility the most recent COVID-19 vaccine administered was in hospital. Adverse events resulted in emergency room/department or urgent care. Patient was hospitalized for these events. Treatments included morphine, colchicine, and indomethacin. Outcome of the events was not resolved. Patient also received the second dose of BNT162B2 (lot number: EW0169) on 17May2021 15:45 in left arm. Follow up needed, further information has been requested.
47 2021-06-07 numbness, coordination abnormal, weakness, tingling Neurological, I started getting numbness and tingling all over body shortly after receiving vaccine,... Read more
Neurological, I started getting numbness and tingling all over body shortly after receiving vaccine, particularly in hands and feet. Occasionally still experience those symptoms along with generalized weakness and fatigue. Also problems with muscles coordination and feeling of being stuck. That night felt more sick, woke up the next day and felt better.
47 2021-06-07 numbness, tingling Delayed response (of about 6-weeks) between 2nd vaccine and immune response. Averse event in the fo... Read more
Delayed response (of about 6-weeks) between 2nd vaccine and immune response. Averse event in the form of rash on back up upper arms (between shoulder and elbow). Rash was red and raised, slightly itchy. Benadryl was taken at home. Two days later, I experienced numbness and tingling on the right side of my face. I was directed to the ER. CT scan as done (normal), stroke ruled out, and prednisone given. 20 mg tablets/3 taken at once/ once a day for 5 days. Numbness and tingling subsided, rash no longer raised but still splotchy. Off prednisone now and tingling has returned.
47 2021-06-07 numbness, tremor Lightheadedness; Numbness and weakness in both arms; BP dropped from 130/70 to 119/64; Heart rate sp... Read more
Lightheadedness; Numbness and weakness in both arms; BP dropped from 130/70 to 119/64; Heart rate spike from 65bpm to 167bpm; shortness of breath; body shaking badly
47 2021-06-07 numbness allergic reaction; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to he... Read more
allergic reaction; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; swelling and numbness to her mouth, lips, and tongue; face was numb and heavy; face was numb and heavy; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number: 59267100002), via an unspecified route of administration, administered in the left arm on 09Mar2021 at 15:00 at the age of 47 years old (Batch/Lot number: FN6198/EN6198, and Expiration date: unknown) as the 1st dose, single dose for COVID-19 immunization, to protect herself from getting COVID-19. The patient had no medical history. There were no concomitant medications. The patient reportedly experienced swelling and numbness to her mouth, lips, and tongue on an unspecified date in Mar2021. The patient was asking if there was any research to determine what she might have reacted to in the vaccine and also if there was any information about the kind of reaction she had and if that would relate to a specific ingredient. It was further reported that the patient had an allergic reaction to the first dose of the COVID vaccine and did not provide specifics. The patient wanted to know if there were studies on allergic reactions and if there had been any follow ups and would love to know what she was allergic to, since she had never had an anaphylactic reaction and if there had been any research. The patient stated she was seen at the emergency room and did not know if she should share the doctor's information that had seen her in the emergency room or her primary care doctor. She had mouth, tongue, lip swelling and numbness and so she went right away to the emergency room. She never had breathing distress and was given an intravenous (IV) steroid and also a medication to bring down the swelling. The patient stated she had the vaccine around 3pm in the afternoon and she woke up around 3am during the night on an unspecified date in Mar2021 and her face was numb and heavy and her lips were huge and she realized she was breathing ok, but she went to the emergency room. The patient stated she wanted to get the second dose of the vaccine, but the emergency room doctor did not recommend it. She clarified that the symptom of her mouth tongue lip swelling and numbness had actually occurred sometime in Mar2021, and not Feb2021, since she got the vaccine on 09Mar2021. It lasted for about two days until it went down. The patient stated there had been no changes and she had not had anything different to eat. Therapeutic measures were taken as a result of all the events, which included IV steroid and a medication to bring down the swelling. The patient recovered from all the events on an unspecified date in Mar2021.
47 2021-06-07 pain in extremity On 5/20, patient experienced a sore arm. Then on the same day she developed dizziness, tightness in ... Read more
On 5/20, patient experienced a sore arm. Then on the same day she developed dizziness, tightness in the throat, body aches, a low grade fever, headache, fatigue and it felt like the roof of her mouth was on fire. Now nearly 3 weeks later she still has a low grade fever (99.7.) She has been taking Tylenol and Ibuprofen and is staying very well hydrated. She does not know if her temperature is actually higher than what is registering because she is medicating herself. She also still feels very tired and has an occasional headache. The sore arm barely lasted a day. Her biggest complaint is that the fever has not subsided and she still feels tired.
47 2021-06-08 muscle twitching, numbness, tingling, nerve pain, burning sensation Tachypnea, Tachycardia, feet, legs felt heavy, shoes felt tight, had chest tightness Narrative: ... Read more
Tachypnea, Tachycardia, feet, legs felt heavy, shoes felt tight, had chest tightness Narrative: Had to go to the emergency was discharged the same day from the emergency department, was not admitted to the hospital, went home and continued to monitor herself for symptoms, states her legs/feet were numb, tingly, and felt very heavy, with severe pain (worse pain of her life), it was nerve pain, legs were twitching, felt like everything on the inside was on fire. Today still feels feet and toes a bit tingly, face is red from the steroids she was given in the ED. Had a complete work up in the ED: CXR, blood work, EKG.
47 2021-06-08 night sweats Hormonal dis regulation. I am very regular due to hormone therapy. About two weeks after vaccine had... Read more
Hormonal dis regulation. I am very regular due to hormone therapy. About two weeks after vaccine had night sweats for a week and then started my menses on day 19 in my cycle which has never happened. Also got a yeast infection- haven?t had one of these in many years. I have also randomly gained 10 lbs- I?m guessing due to something with my estrogen. I have also been extremely depleted feeling since the second vaccine, I?m used to low energy but this depletion has been more than normal for me. This second menstral cycle that I?m getting ready for seems like I will start late.
47 2021-06-08 pain in extremity covid-like symptoms; Stiff sore arm; Stiff sore arm/ tired sore legs; extreme fatigue; loss of appet... Read more
covid-like symptoms; Stiff sore arm; Stiff sore arm/ tired sore legs; extreme fatigue; loss of appetite; Feverish; This is a spontaneous report from a contactable consumer or other non hcp. A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration on 20Mar2021 as unknown, single dose for covid-19 immunization. Medical history included covid-19 and allergies to Latex, shellfish and fruit. The patient's concomitant medications were not reported. On 21Mar2021, the patient experienced Covid-like symptoms, stiff sore arm, stiff sore arm/ tired sore legs, extreme fatigue, loss of appetite and feverish. Events were not treated. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test was unknown. The outcome for all events was unknown. No follow-up attempts are possible. No further information is expected.
47 2021-06-09 breast pain, feeling cold 01/17/2021 I woke up around 5 and I have cold and chills, it took about 3 days to go away then I wok... Read more
01/17/2021 I woke up around 5 and I have cold and chills, it took about 3 days to go away then I woke up with a large lump in my arm pit and breast- left side. It was very painful, I went to ER.
47 2021-06-09 paralysis Paralyzed; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female... Read more
Paralyzed; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in the right high shoulder (right deltoid) on 27Mar2021 at 10:03 at the age of 47 years old (Batch/Lot Number: ERZ613 OR ER2613) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), at the age of 47 years old, batch number: EN6205 on 06Mar2021 at 10:11AM or 09:11AM given in her right high shoulder as an injection for COVID-19 immunisation. The patient was calling about the COVID 19 vaccination that she received. She stated that with the first dose, she did not feel anything, and she is calling to report on the second dose. She has spoken with Pfizer before, but she had questions and she was told how to go about it. She stated she received the vaccine and the symptom started exactly 8 hours after. She got the vaccine at 10:05AM or 10:03AM and it was about 9:03PM when the symptom started. She stated she got the vaccine probably at 10:03AM on 27Mar2021 and she was paralyzed. She stated picture someone laying there, it went into the right arm and then went into left and paralyzed there then it came down from the top to across her chest and shot straight down and missed the breast area and went into the ribs then it paralyzed her left leg and shot right across and paralyzed her whole right thigh and all she knows was that she could not move. She was paralyzed, and it shot into her and came across and then straight down. She stated it just did it at the moment exactly 8 hours and it started at around 9:08pm. She clarified, well it started actually 11 hours after the vaccine and not 8 hours. She wanted to say it lasted for 2 minutes where she could not move for a while and it was strange. The exact time was maybe 2 minutes after it started was when it stopped. She clarified and stated, well actually it lasted a couple of hours and stopped at 11:08PM. She stated she is not sure if she has recovered completely from this. The event outcome was unknown.
47 2021-06-10 flushing Patient received Pfizer dose . Son called out for assistance as patient appears "passed out". Patien... Read more
Patient received Pfizer dose . Son called out for assistance as patient appears "passed out". Patient was sitting in chair. Vitals 1205: 97.8, 52, 117/70, 98%. Patient states she feels "faint, dizzy and nausea". Patient looks flushed. Legs elevated, patient laying down. Last set of vitals at - 52, 102/66, 98%. No meds given. Patient nausea gone. States she feels "much better"
47 2021-06-10 numbness and pain in extremities Flare-up of Ulcerative Colitis - started 4 days after 1st shot. Got worse immediately after 2nd shot... Read more
Flare-up of Ulcerative Colitis - started 4 days after 1st shot. Got worse immediately after 2nd shot. Diarrhea, extreme bloating, gas trapped in GI tract, inflammation of GI tract. Extreme abdominal cramping. GI dr confirmed generalized small-bowel dysmotility as a consequence of the vaccine. Also confirmed mild flare of Ulcerative Colitis and was given Prednisone as treatment. Also 1 week after vaccine developed sharp pain in lower back left side of skull, could not turn head. Went to neurologist, diagnosed with occiptal neuropathy and given nerve block injections to treat.
47 2021-06-10 pain in extremity Arm pain, H/A, Whoozy Vital Signs: BP 155/90 HR 68 Resp 18 Skin Signs: Warm and dry Circulation: ... Read more
Arm pain, H/A, Whoozy Vital Signs: BP 155/90 HR 68 Resp 18 Skin Signs: Warm and dry Circulation: Cap Refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Sat in triage, drinking water 2:20 PM Vital Signs: BP 140/83 HR 61 Resp 12 O2Sat 99 Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: Observation 2:25 PM Vital Signs: BP 130/78 HR 60 Resp 10 O2Sat 96 Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Notes: Sent home with father. Feeling better. Still arm pain. Will f/u if not continuing to improve.
47 2021-06-11 pain in extremity aching ears and ringing in my ears something awful; aching ears and ringing in my ears something awf... Read more
aching ears and ringing in my ears something awful; aching ears and ringing in my ears something awful; my arms and legs were so achy, really bad achy; couldn't walk; felt like she couldn't stand; itching behind the eyes; itching on her scalp; Bowel movement each time after she ate; sleepy; exhausted and tired; I was so dizzy; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 27May2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable nurse (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 06May2021 09:30 (at the age of 47-years-old) (Batch/Lot Number: EW0182) as single dose for covid-19 immunization. Medical history included vertigo, happened a couple of years ago, happened once or twice but not frequent, she thought happened when she had sinus thing and during the pandemic, she gained weight, 10 pounds. There were no concomitant medications. There were no additional vaccines administered on same date of the Pfizer suspect. There were no prior vaccinations (within 4 weeks) and Usually the patient did not get vaccinations. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Left on 14Apr2021 09:30 (Lot number: EP7533) as single dose for covid-19 immunization. The patient received her second Pfizer vaccine dose on 06May2021. Beginning on 12May2021 she began having side effects. The patient googled the side effects information and it said the side effects would start 1-3 days after the vaccine dose. Her symptoms started 7 days later. On 12May2021, her arms and legs were so achy, really bad achy, she took tylenol because there was a lot of pain and aching in both arms and both legs. She took tylenol and it help a lot. Then the next day, it all came back and the tylenol didn't help. That really scared her. She still was aching around the clock even with taking tylenol all day. Then the 3rd or 4th day, no more aching in her arms and only in her legs. On 14May2021, She then began having aching ears and ringing in her ears something awful and she was so dizzy in May2021. The dizziness and ringing were still happening today but it got better each day. The patient said 7 days after the shot, she had severe aching in the arms and legs, bilaterally. She felt like she had done a hard work out for 5 hour and couldn't walk on 12May2021. Tylenol helped. The next day it came back. Tylenol didn't help, but may have taken the edge off. On the third day, it happened again in just the legs and not the arms, the arms were not aching. Then she had aching in the ears and ringing in the ears. She was very dizzy. The ringing and dizziness continued, but it was getting better each day. Confirmed that it was the Pfizer Covid vaccine. She was sleepy, real sleepy at first on 06May2021. She didn't think this was a side effect, but now she thinks so. She did not have diarrhea, but she had to go to the bathroom every time she ate on 06May2021. Usually she went only once a day, but after getting the shot she going 3 times per day. That was not her usual. That started the day of the shot. She clarified that she had pain, it was in her arms and legs. She woke up all 3 days with aching. It came out of nowhere. She had bowel movements 3 times per day on 06May2021. She was sleepier. She felt like she needed to rest. On day 7 or day 6, she woke up in so much pain. Her arms and legs hurt. She stood up and felt like she couldn't stand on 12May2021. She wasn't thinking of shot at first. She talked to her family. Then she thought maybe it was the shot. Tylenol worked. The next day the Tylenol did not work. It helped deal with the pain. It made it tolerable. It dealt with the pain. Then it seemed like it was getting worse. The Tylenol wasn't working. The third day she got real afraid. She was really in pain. She was really exhausted and tired in May2021. She went to sleep. She had pain. She took Tylenol. She was ready to go to the ER. She talked to nurses. She talked to her PCP (Primary Care Physician). PCP did not think it sounded like vaccine. She took test for Covid on 17May2021. The test was negative. She wasn't around anyone. She didn't get the test that same day, not until the third day when her legs were hurting. She was in so much pain that day. Her arms were not hurting. She felt a sigh of relief. It was late after the news was on TV. It was after 11:00 at night. She started taking 2 Tylenol at once. Then she thought the Tylenol was making it worse. Her body was fighting with the Tylenol. The pain in her legs and arms started 12May2021. She felt like it was in her bones and muscles. It gradually went away. When the ringing in the ears first started, her ears felt like what was happening in her legs. It felt like nerves. It was the same signals. She didn't have chills. Caller described that it almost mimicked and felt like it sounded, like circulation. It felt like when you lay on your arm and it falls asleep and it felt like the shaking you do to wake it up. It felt like tingling. Caller said that it is improving but lingering. It occasionally happens and is scary. Everyday it felt better. Later on 09May2021, she had itching behind the eyes. This went away. She also had itching on her scalp on 09May2021 which was still going but improved. The event severe aching in arms and legs required a visit to Physician Office by Tele-visit and did not require a visit to Emergency Room. Tylenol did not work at times for the severe pain in her arms and legs. The seriousness of event Aching and ringing in ears was reported as disabling and the events severe aching in arms and legs, Bowel movement each time after she ate, Sleepy, Itching behind eyes and Scalp itching was not serious. The outcome of the event arms and legs were so achy was recovered on 17May2021, the outcome of the event itching behind the eyes was recovered on 18May2021, the outcome of the event sleepy was recovered on 20May2021, the outcome of the events aching ears and ringing in ears and itching on her scalp was recovering and the outcome of the other events was unknown. The reporter considered the events Severe aching in arms and legs, Bowel movement each time after she ate, Aching and ringing in ears, Sleepy, Itching behind eyes and Scalp itching were related to Pfizer Covid Vaccine.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events cannot be excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-06-11 tingling PATIENT COMPLAINED OF DIFFICULTY SWALLOWING AND LOWER LEGS FELT "ASLEEP AND TINGLING 15 MINUTES AFTE... Read more
PATIENT COMPLAINED OF DIFFICULTY SWALLOWING AND LOWER LEGS FELT "ASLEEP AND TINGLING 15 MINUTES AFTER VACCINATION. REGISTERED NURSE AT CLINIC ADMINISTERED DIPHENHYDRAMINE VIA IM RIGHT ARM. VITALS MONITORED AND 911 WAS CALLED. PATIENT TAKEN AWAY BY EMT.
47 2021-06-12 weakness Dizziness, weakness since full onset 12:00pm
47 2021-06-13 cold sweat She got her vaccine, she came home and was fine. Her mother had her APT and she herself was a littl... Read more
She got her vaccine, she came home and was fine. Her mother had her APT and she herself was a little bit dizzy and she took her mother for her vaccine APT. Then they went to the mall and she just started not to feel good, and had a stomach ache, diarrhea and left due to her not feeling well. That night she just started to feel horrible, and at 6:22 AM was was not feeling well, and had every single symptom of the reactions, brain fog as well. She also had a fever up to 101.5 at 12:55 PM on 4/1/21. She progressed to getting sicker, shortness of breath and worsening symptoms with highest temp of 101.7. On 4/2/21 she started feeling better and her fever was normalizing and had cold sweats, and the initial symptoms of nausea would come and go and still had stomach issues for days afterwards, but the fever did not come back. Then she started having chest pains, shortness of breath that lasted for 3 weeks afterwards. She went to the UC on 4/14/21 and vomited again and got concerned that she was still having the chest pains and was getting sicker. She informed them at the UC that she believed she was having symptoms related to the vaccine and the doctor there had informed her that it could not have been related to the vaccine and "written off" and nothing else was said about the vaccine after that. She never saw a Dr., they did do an EKG and was told that it was normal and was told that she was going to send her to the ER "as she matters". She informed them that she did not want to go to the ER and was informed that she would be seen right away as she was not feeling well enough with the nausea and sick. The ER was packed and was triaged and they told her that she would be seen and none of that happened. She supposedly got triaged and had an EKG and was informed that she would be written off about it and that they were making it a political thing. She had an IV line inserted, and had blood drawn and after 2 hours nothing had been done. After about 3 1/2 hours being in the ER and after she had made a big fuss and was put in a room. They sent somebody in and informed her that she had a cardiologist in her family and a GP and if they weren't going to see her to let her go home. She was then sent in another nurse who was more understanding and he went over the EKG with her and told her that it was strange and said that her heart beat was normal, and then at some point that it skipped a bit and then had a subsequent EKG and that was abnormal as well but in a different way. Then another nurse came in and told her that they wanted to run tests every hour and never mentioned to admit her, for her to stay in the ER but did not feel they were comfortable sending her home, and that her shortness of breath was concerning to her. She was progressively feeling worse and was not seen by a cardiologist and they sent her home to FU with one. She went to see a cardiologist and by then it was documented that there were some people were having heart issues from the vaccine. He then ordered her an echocardiogram and a stress test, and then did not hear anything from the office. They had not gotten an authorization from the insurance company and she called her insurance company and they informed them that she was approved and that she is to have an urgent stress test. At this point she does not know what's going on. Subsequent to the vaccine she has had normal EKG's for 5 years, and now since the vaccine she has not felt well, she has insomnia, anxiety, fatigue, depression, shortness of breath and chest pains every day and has abnormal EKG's. She has been given prescribed Prilosec only, nothing for her heart and acid/reflux heartburn medications. She was also given anxiety medication that she takes prn. She is scheduled for Friday, 6/18/21. She has been given prescribed Prilosec only, nothing for her heart and acid/reflux heartburn medications. She was also given anxiety medication that she takes prn. She is scheduled for Friday, 6/18/21. She is a caretaker of a 93 year old father, and has not had the sense of taste and smell for over a year, and believes that she had COVID in the spring of 2020 and has the metallic taste as well. She is having severe chest pain and is concerned and scared that something is going to happen to her and she will not be able to take care of him. She was not tested, but had tried but they would not test her at clinic and did not go and get tested as she did not want to take the chance to get the virus. She did have a test done this year and was informed that it was negative. She is scared that this could be a long-term condition and she is terrified that these symptoms will not go away at all. She was exposed back in 2015 of a very bad gas leak and now her father has asthma, and they believe that is related to the gas leak, and wanting to know if that?s what she has as well. She states that she has never felt like she has been normal since taking the 2nd vaccine.
47 2021-06-13 discomfort Onset of headache 56 hours after first dose, on Sunday May 30, 2021 at 7 pm. Headache did not compl... Read more
Onset of headache 56 hours after first dose, on Sunday May 30, 2021 at 7 pm. Headache did not completely resolve until 11 days later after June 9, 2021. I took OTC ibuprofen, slept more than usual, took pseudoephedrine , extra caffeine and remained fed and hydrated. Nothing helped ease the pain and discomfort. I had two chiropractic adjustments which relieved the headache right away, but within 2 hours the pain had started to return. This headache felt like a vice grip around my head, buzzing and full ears, difficulty focusing eyes and then related eye pain, tightness in neck and jaw. This is not a usual circumstance for me. The same headache pain has started to return today, June 14, 2021.
47 2021-06-13 numbness Patient reported tightness in throat, numbness in face, headache and had dry heaves shortly after r... Read more
Patient reported tightness in throat, numbness in face, headache and had dry heaves shortly after receiving the second dose of Pfizer COVID vaccine.
47 2021-06-14 numbness Patient complained of numbness, tingling on her left jaw and left hand. Vital signs as follows: B.P:... Read more
Patient complained of numbness, tingling on her left jaw and left hand. Vital signs as follows: B.P: 109/67, H.R 77, O2 Sat 97%. Patient went home after symptoms were resolved.
47 2021-06-15 tremor vaccine administered at 0906am patient was instructed to wait 30min off to side due to history of al... Read more
vaccine administered at 0906am patient was instructed to wait 30min off to side due to history of allergies. no history of anaphylaxis. checked on patient about 10 min after dosage administration of 2nd Covid vaccine. no prior anaphylaxis or allergy to 1st covid vaccine. She reported feeling dizziness. had patient recline and consume water. offered granola bar. -vitals stable- BP 124/93 HR 54 O2 96% RA. lungs clear, HR regular rhythm no murmurs. -patient with shaking of left hand and continued dizziness. started to report tongue numbness. no SOB, CP or difficulty breathing. -medications: 0.5ml diphenhydramine 50mg/ml was administered into L arm. -prior to administration patient reported feeling better, dizziness had improved. -patient continued to improved dizziness, resolved, no further tongue tingling and tremor resolved -I suspect patient experienced dizziness post vaccination with a component of anxiety. with history of allergies administration of IM benadryl was discussed and administered without further side effect. patient was stable and drove home at 0950am.
47 2021-06-16 depressed level of consciousness within 10 minutes of 2nd vaccine - I got extremely dizzy and felt as I had a cloud around my head - ... Read more
within 10 minutes of 2nd vaccine - I got extremely dizzy and felt as I had a cloud around my head - after a little while I told nurses on duty they took me in the back and watched my vital signs until normal range. Then on Saturday morning noticed a rash/hives on neck and upper collar bone area. Sunday evening did a call to see what I could take/do for the itchiness as the antihistamine that I take daily for allergies wasn't helping at all! Suggested I add topical cortisone cream. Monday 6/14/21 contacted my allergist as now I also have the rash/hives on arm, he suggested I take an additional dose of either Claritin or Allegra to help and if have trouble breathing go to ER. Tuesday 6/15/21 evening noticed additional rash/hives on either side of hip area and stomach area. I continue to have this rash/hives - although it does seem to be going away very very slowly with the added antihistamine
47 2021-06-16 pain in extremity Had nausea, fatigue, fever, sore arm, itchy throat under left ear etc. Later buzzing sound noticed ... Read more
Had nausea, fatigue, fever, sore arm, itchy throat under left ear etc. Later buzzing sound noticed constantly, in the left ear, after May 21st. Tinnitus
47 2021-06-17 weakness, tingling After second covid vaccine received on 04/29/2021 my left arm , where I received both vaccinations, ... Read more
After second covid vaccine received on 04/29/2021 my left arm , where I received both vaccinations, started to feel like pins and needles. My arm directly under side of arm where vaccine was given is the starting point of the pins and needles. That spot always has a tingling sensation. Then the pins and needles travel down my entire left arm and through my wrist and fingers. At one point it felt as though there was a hair under my skin on my left forearm. The hair sensation went away but the pins and needles became stronger. I have lost strength in my left hand as I cant feel to hold something in my fingers due to the pins and needles. Sometimes the sensation is so strong it is very uncomfortable. I try to shake my arm as you would when your foot fell asleep and you are trying to get the blood flow back to make the pins and needles go away. It is very uncomfortable and can also make it hard to sleep at night.
47 2021-06-17 muscle spasms, numbness, muscle twitching I started having muscle twitches and spasms my legs. They then started expanding to my legs arm back... Read more
I started having muscle twitches and spasms my legs. They then started expanding to my legs arm back neck, abdomen, everywhere. I had some numbness in my hands and feet. For a month they continued at a lesser level. Currently, those symptoms persist at a lower level. I had multiple tests and imaging done. I am currently attending physical therapy. It has not really helped with my symptoms.
47 2021-06-17 muscle spasms I experienced urinary retention and muscle spasms in my torso/midsection. It lasted about 1-2 weeks.... Read more
I experienced urinary retention and muscle spasms in my torso/midsection. It lasted about 1-2 weeks. I visited many doctors. The doctors did not find anything unusual.
47 2021-06-18 numbness, muscle spasms, pain in extremity 6/9/21 - 6/10/21: left facial nerve numbness, 8p - 5a (treated with ibuprofen) 6/10/21 - 6/13/21: ... Read more
6/9/21 - 6/10/21: left facial nerve numbness, 8p - 5a (treated with ibuprofen) 6/10/21 - 6/13/21: thigh and back muscle soreness, headaches, low grade fever (100 - 101 deg) (treated with ibuprofen and tylenol) 6/14/21 - 6/15/21: progressively worse thigh, back, neck spasms, headaches, fever (treated with ibuprofen and tylenol) 6/16/21: went to Hospital / ER with symptoms of pulmonary embolism, heart attack (chest pains, shortness of breath, extreme pain in torso, back, neck) - did blood work on D-dimer, platelet analysis, CT Scan - confirmed no PE or heart attack enzymes, but low platelet count (115k) - given fentanyl for pain and an IV dose of dexamethasone steroids, discharged at ~11pm 6/17/21 - 6/18/21: improved symptoms, just slight discomfort in lower back 6/19/21: symptoms re-emerged with debilitating lower back and thigh pain; on-call Dr. prescribed prednisone steroid, taking muscle relaxers and ibuprofen ,
47 2021-06-19 tingling Day 1 started with tingling in the left arm and hand. By Day 2 progressed to tingling/pins & nee... Read more
Day 1 started with tingling in the left arm and hand. By Day 2 progressed to tingling/pins & needles in both hands and both feet. Periodic burning sensation in the palm of both hands. These symptoms have not subsided. Tuesday June 22 will be 2 weeks since my vaccination.
47 2021-06-20 weakness I started to get swollen, my stomach was big, I had severe headaches, I was swollen, I felt sick, no... Read more
I started to get swollen, my stomach was big, I had severe headaches, I was swollen, I felt sick, not strong, like if I had the flu, my eyes were really dry and big, I noticed my hair got really dry, I could not do my normal day activities, I was moving too slow, I was struggling, I was frustrated brushing my teeth, I was tired and drained, I could not taste food, I started to get bloody mucus. I got really worse with my second dose. I decided to go to the doctor maybe 2 weeks after getting my second dose. He gave me Loratadine because he thought it was an allergy.
47 2021-06-20 burning sensation Within the first 10 minutes, I felt a burning sensation run up the left side of my head. I felt diz... Read more
Within the first 10 minutes, I felt a burning sensation run up the left side of my head. I felt dizzy as if I were going to faint but I tried to relax and felt a little better. I left after 15 min and then I felt very dizzy again same reaction except I could feel burning sensation throughout my entire body down to my toes. I asked my husband to turn around and go back to facility. They took my blood pressure, which was high 176/9? I thought I was dehydrated, so I kept drinking water. Then I relaxed a little and the symptoms relaxed a bit. They took my blood pressure again and it went down to 146/? I was feeling okay and we were heading home and then I got another episode like I wanted to faint. We headed to hospital and they ran tests. Tests were fine. They gave me an IV with liquids, I felt better after leaving. I was fine for 2 day but then on the third day I broke out in rashes on my legs. It's been a week and feeling a bit better each day dizziness is fading but not entirely gone.
47 2021-06-21 migraine I had a low grade fever starting the second date of the second dose which quickly rose beyond 101. I... Read more
I had a low grade fever starting the second date of the second dose which quickly rose beyond 101. I took Tylenol which was able to reduce the fever. At the same time, I had a mild headache that lasted about 5 weeks, during which it escalated into a migraine (I never had migraine before) where I became super sensitive to light and sound and felt constant pressure around my ears. I sought treatment from a acupuncturist (10 visits), chiropractor, massage therapist, and took medication prescribed by my GP including Sumatriptan Succinate, Advil (high dose), Cyclonbenzaprine (muscle relaxtant), Predisone 20 mg/day for 5 days. I felt a transient relief when I was on Advil/Predisone but the headache returned after I st after I stopped the medication. I saw a neurologist who prescribed Botox injection. I had a brain MRI with contrast on the 4th week post my vaccination and the result showed white matter accumulation consistent with a migraine. On the sixth week, the headache went away.
47 2021-06-21 pain in extremity Deep vein thrombosis left leg, Lovenox f/by Pradexa. On 5/28/21, received pfizer covid vaccine 2nd d... Read more
Deep vein thrombosis left leg, Lovenox f/by Pradexa. On 5/28/21, received pfizer covid vaccine 2nd dose. On 5/29, visited . on 6/1/21, noted Lf leg pain. 10 days later, noted severe pain and swelling. ED visit on 6/11/21
47 2021-06-22 migraine, hot flush I noticed I was not getting rid of any headaches or migraines and my menstruation was not there. I h... Read more
I noticed I was not getting rid of any headaches or migraines and my menstruation was not there. I had hot flashes extreme exhaustion and I was unable to sleep at night all of these symptoms are very similar to symptoms of menopause. After being tested, it was concluded I was not going through menopause. After 90 days the symptoms went away and everything is pretty much back to normal. I still have occasional headaches that may be due to allergies. I also noticed my sense of smell has been impacted I can't smell roses or other floral scents. I am still experiencing mild levels of tiredness from time to time.
47 2021-06-22 pain in extremity Later that afternoon I felt like a ton of bricks hit me. Almost like I was going to faint. When I go... Read more
Later that afternoon I felt like a ton of bricks hit me. Almost like I was going to faint. When I got home my arm was swollen and red. I started having a bad bowel movement, no fever, stiffness, joints aching, and dull aches. I had a hard time resting. The next day when I woke up, I had a bowel movement bad. When I went downstairs, I was bleeding from light to medium from my vagina. For 4 hours I had sharp pains in the middle of my chest. I went to see Doctor; my symptoms were gone for 5 days. Then 10 days ago my eyes were tearing a lot and painful. I went walking and had incredible pain in feet, ankle, knee, and I could barely stand. The next morning, I went to my PCP and referred me to a RA doctor and think it's an autoimmune disease.
47 2021-06-22 tingling History is provided by the patient. This is a 47 year old female with self reported past medical his... Read more
History is provided by the patient. This is a 47 year old female with self reported past medical history of nephrolithiasis who presents to the ED with concerns for allergic reaction. Received second dose of the COVID vaccine around 08:00 am this morning. About 20 minutes later, she started to feel constant shortness of breath in addition to feeling like she was going to pass out with associated nausea and tingling to her hands and feet. No modifying factors reported. She presented to the ED for further evaluation. She had a similar reaction on receiving her first dose of the COVID vaccine, but notes this episode feels worse. Lungs are clear to auscultation. No signs of angioedema. No clinical signs of an allergic reaction. Due to patient's complaints, will provide Solu-Medrol, Benadryl, and famotidine. Will also obtain EKG. Discussed indications for epinephrine, will hold off epinephrine at this time and re-assess. 09:33- On re-assessment, patient now with periorbital edema. Airway still intact and voice is clear. However, will provide epinephrine now. The patient was treated with intravenous fluids (IVFs) for the following reason: concerns for dehydration, dry mucous membranes. Patient improved after IV fluid administration. Patient is reassessed multiple times, with improving symptoms At 4 hours status post epinephrine, patient with no rebound symptoms, patient states that she is feeling better, ready for discharge home. Due to anaphylaxis, will provide additional epinephrine prescription for home. Allergy added to patient chart.
47 2021-06-23 numbness, discomfort, pain in extremity Patient presented to ED 6/16 with chest pain. Patient got her second Covid vaccination a week ago t... Read more
Patient presented to ED 6/16 with chest pain. Patient got her second Covid vaccination a week ago today. That night she said she had some numbness on her face from mid lip and chin to the left side of her face. When she went to bed that night she slept when she woke up that numbness was gone and has not had any since. She is having body aches now she said the next day she had a lot of bilateral hip pain that seemed to improve some but now it is pain mainly in her back both upper and lower in her ribs. She also has some anterior chest pain feels short of breath hurts to take a deep breath. No other complaints she says she is had some low-grade temperatures in the low 100 200.2 may be 100.5 periodically and some chills. Patient was in fair amount of discomfort very pleuritic breathing. Given 50 mcg of fentanyl 4 mg Zofran IV. She actually doing better. Reviewing her records her platelets run about 240,000. This is cut in half. She did not have a significant headache and not concerned about an venous thrombosis in the brain however I am concerned about a pulmonary embolism. CT scan obtained and reviewed as below negative for PE or acute abnormality. Repeat troponin negative, doubt ACS. Possible Covid reaction. No other significant findings on ED work-up today. Patient given IV Decadron and repeat dose of fentanyl. She is comfortable with plan discharge home with close outpatient follow-up. Presented again to ED 6/20 with 12 hours of progressive now constant severe low back pain radiating diffusely about the low back into both hips down the back of both legs. Told to F/U with PCP. F/U with PCP on 6/21 and 6/23. One possibility is new onset ITP or immune thrombocytopenia. Plan to Prednisone taper over 3 weeks, also H2 blocker prescribed. CBC twice weekly; follow up CMP with next draw . CTA abdomen rule out portal/mesenteric vein thrombosis or consumptive thrombocytopenia. Tramadol prn pain.
47 2021-06-24 facial pain, tingling, pain in extremity, numbness right side facial pain; Right side jaw pain; Right side facial and arm tingling; Right side lip ting... Read more
right side facial pain; Right side jaw pain; Right side facial and arm tingling; Right side lip tingling; Right side of facial and arm numbness; Right side of lip numbness; fever 101-102+; arm pain; body aches; headache; nausea; chills; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6206), via an unspecified route of administration in the left arm on 15Mar2021 at 14:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included pituitary adenoma. She was allergic to sulfa and codeine. Concomitant medications included Loestrin w Iron BC and cabergoline (MANUFACTURER UNKNOWN) taking for unknown indications and were received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 22Feb2021 at 14:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. She did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, she was not diagnosed with COVID-19. Since the vaccination, she had not been tested positive for COVID-19. On 16Mar2021, at 03:00, the patient experienced fever of 101-102 plus, arm pain, body aches, headache, nausea, and chills. On 16Mar2021, at 16:00 she took tylenol, one every 4 hours for 3 days as a treatment and most of the events were recovered by 17:00 to 18:00 on 16Mar2021. After 72 hours on 18Mar2021, she had experienced right side facial/jaw pain, right side facial/lip and arm tingling along with numbness and these reactions continued on-off all day, and were ongoing at the time of report. The patient did not receive any treatment for the events. The clinical outcome of the events fever, arm pain, body aches, headache, nausea, and chills were resolved on 16Mar2021 whereas, the clinical outcome of the events right side facial pain, right side jaw pain, right side facial and arm tingling, right side of facial and arm numbness and right side of lip numbness was unknown. No follow-up attempts are needed. No further information is expected.
47 2021-06-24 flushing I had no reaction immediately after the injection. It started about a week later, I developed a rash... Read more
I had no reaction immediately after the injection. It started about a week later, I developed a rash on the back side of my left knee and some random spots on my arms and legs. I assumed it was just an eczema flare and didn't even think that it might be related to the vaccine because I felt fine after both injections. The rash behind the knee got worse. I was given a steroid shot by my physician when I went in to see him and a Medrol dose pack with some Clobetsol cream. As soon as I finished the steroid, the rash came back and spread to different spots. I was then given Prednisone and the same thing happened and continues to happen as soon as I stop the steroid. I went to the dermatologist and they biopsied it and it came back at an allergic reaction but no one will test or can test to see if it's to the vaccine I am told because it's so new. I went to the allergist and they didn't test. The rash had caused a malar flush and for a minute they thought I had developed Lupus and nothing to do with the vaccine. I have now had blood work that has ruled out lupus but I will be finishing the 5 round of steroids soon and still have no answer. I do not know if it's related to the vaccine but that is the only new thing I have been exposed to. I am afraid that this is related to the vaccine and no one will tell me how long it will or can last since it's so new and nothing is known. I don't want to keep taking steroids but as soon as I stop, it comes back. I am not even sure that filing this out is the right thing to do.
47 2021-06-24 flushing Patient describes flushing and face, neck and upper chest, dizziness and lightheadedness that starte... Read more
Patient describes flushing and face, neck and upper chest, dizziness and lightheadedness that started 45 minutes after the vaccine was administered. She had already left the clinic at this time. She did not take any medications or seek any medical attention. The symptoms resolved 45 minutes after they started. She subsequently consulted with her primary care provider, who advised her not to get her second vaccine dose and referred her to an allergist for further evaluation and advice.
47 2021-06-24 numbness Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient said she ha... Read more
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient said she had numbness occure 2 hours after first shot. numbness in left neck,left chest,left arm,left shoulder
47 2021-06-24 tingling Soreness at the injection site; Mild itchy tingling type sensation and a mild pins and needles sensa... Read more
Soreness at the injection site; Mild itchy tingling type sensation and a mild pins and needles sensation all over her body; Mild itchy tingling type sensation and a mild pins and needles sensation all over her body; This is a spontaneous report from a contactable other hcp. (patient). A 47-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Right on 15Mar2021 15:58 (at the age of 47-years-old) (Batch/Lot Number: EN6206) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ear disorder from 03Feb2021 to an unknown date. Caller stated this is all COVID issue post COVID. Caller stated this ended within the last maybe week or so. Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease, start and stop date were not reported. The patient previously took a medication which was a steroid called Methylprednisolone for her ear problems that she ended up discontinuing because she had an adverse effect to the medication, so she discontinued it on 15Feb2021. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations details was reported as none. Caller stated she received the vaccine on Monday 15Mar2021 at 15:58 HR and three hours later noticed a pen and needle itchy sensation all over the body and it is mild not severe. Caller stated it was noticeable of course more like annoyance right now. Caller stated the other symptom was soreness at the injection site (on 15Mar2021 20:00). For pen and needle itchy sensation all over the body the as time went on and the following day it was a moderate type soreness then started declining so it is improving. Caller stated she was still feeling a little soreness, but it was improving. Called stated she was not certain of the seriousness criteria of the pen and needle itchy sensation all over the body. Caller stated she knew it was not feeling tingly and the pen needle feelings she did not feel before but now she was felling that sensation and she was not sure if it was connected. AE(s) did not require a visit to emergency room or physician office. Caller stated she tried antihistamine Benadryl (25mg) lot numbers: 1761324, expiration Mar2022, did not really, maybe a minor difference, but sensation is still there so not resolving. The outcome of the events mild itchy tingling type sensation and a mild pins and needles sensation all over her body was not recovered and outcome for soreness at the injection site was recovering. Information on Lot/Batch number was available. Additional information has been requested.
47 2021-06-28 weakness Heart Rate low 40's (Brady Cardia); Chest Pain; Lung Pain; Difficulty Breathing; High Blood Pressure... Read more
Heart Rate low 40's (Brady Cardia); Chest Pain; Lung Pain; Difficulty Breathing; High Blood Pressure; Fatigue; Major Weakness; Oxygen low 80's; Light Headed, Dizzy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot Number: EW0150) (at the age of 47 years) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: EW0169) (at the age of 47 years) as DOSE 2, SINGLE for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included Excessive Factor 8, Seasonal Allergies, Known Allergies: Penicillin, Gluten sensitivity, Inteferon Gold. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (negative). Concomitant medications included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported. The patient experienced Chest Pain, Lung Pain, Difficulty Breathing, High Blood Pressure, Fatigue, Major Weakness, Oxygen low 80's, Heart Rate low 40's (Brady Cardia), Light Headed, Dizzy, on Apr2021. The patient underwent lab tests and procedures which included blood pressure: high on Apr2021, heart rate: low (40) on Apr2021, oxygen saturation: low (80) on Apr2021, sars-cov-2 test: negative on Apr2021 Nasal Swab, sars-cov-2 test: negative on May2021 Nasal Swab. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included Antibiotics, Oral Steroids, Steroid Inhalers. The outcome of events was not recovered.
47 2021-06-28 flushing flushing, palpitations and diarrhea following first dose Pfizer vaccine 3/12/21 with persistent symp... Read more
flushing, palpitations and diarrhea following first dose Pfizer vaccine 3/12/21 with persistent symptoms x 3 days and then with recurrence and new symptom of tinnitus 7 days later which subsequently resolved
47 2021-06-28 numbness 1. Delayed/late menstrual cycle. My periods were very regular. Last period 5/11/21. Around the firs... Read more
1. Delayed/late menstrual cycle. My periods were very regular. Last period 5/11/21. Around the first dose I should have started my period. As of today, my period has still not started. Since the vaccine I am 20 days late, and not pregnant. 2. External numbing of both arms and face (lasted 5 days) 3. Brain fog, malaise (lasted 3 days)
47 2021-06-28 migraine I had the tired symptoms and fatigue next day. They got worse and i had memory issues, speech proble... Read more
I had the tired symptoms and fatigue next day. They got worse and i had memory issues, speech problems, stroke symptoms and severe migraines. I missed 3 weeks of work off and on in May due to all this. I ended up in the ER on May 14 for stroke symptoms and lost use of my right arm and hand for several days. I have been diagnosed with migraines with aura and told I had a severe reaction to the shot and may recover in 6 months. I am on all new meds to try to control my migraines which are now daily and more severe than ever.
47 2021-06-28 tremor Less than a week after my second vaccination shot, i noticed a tremor in my left pinky finger. This ... Read more
Less than a week after my second vaccination shot, i noticed a tremor in my left pinky finger. This subsided after two weeks. It was replaced by muscle tremors all over. My physician has diagnosed them as "intentional tremors." After some bloodwork, my physician concluded that hyperthyroidism was the cause of the tremors. However, in 2019 my thyroid functions were normal as determined by bloodwork. However, since my tremors have started I have spoken to a number of people who have also had similar symptoms since receiving the Covid vaccination. It is my belief that the Covid vaccination may have adversely affected my thyroid and caused muscular tremors.
47 2021-06-29 burning sensation I was tired for a week in my bed sleeping felt terrible got better then had cluster headaches daily ... Read more
I was tired for a week in my bed sleeping felt terrible got better then had cluster headaches daily which now I have a prescription for cluster headaches that I had to take the medicine for the cluster headaches at least every other day. I normally wake up with a cluster headaches now. This is all new and started after the first Covid Vaccine injection. My head will burn and the cluster headaches will last off and on through out the day.
47 2021-06-29 feeling cold, tingling, numbness left arm was freezing cold/hand went cold; hands and feet were numb; tingling throughout both arms a... Read more
left arm was freezing cold/hand went cold; hands and feet were numb; tingling throughout both arms and legs; chest pain; This is a spontaneous report from a contactable consumer. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL8982, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 13:00(at the age of 47 years) as dose 1, single for covid-19 immunisation. Medical history included sulfa allergy, penicillin allergy. Concomitant medications included letrozole (LETROZOLE). Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021 the patient experienced left arm was freezing cold her hand went cold, hands and feet were numb, tingling throughout both arms and legs, she had chest pain. The action taken in response to the event(s) for bnt162b2 was not applicable. Patient visited emergency room for occurred events. Patient did not receive any treatments. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
47 2021-06-29 numbness Throat felt like it was getting tight; left side tongue and cheek numbness; This is a spontaneous re... Read more
Throat felt like it was getting tight; left side tongue and cheek numbness; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6201) via unknown route of administration in her left arm on 11Mar2021 at 17:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patients medical history included thyroid cancer. Concomitant medication included CYTOMEL, citalopram (MANUFACTURER UNKNOWN), SYNTHROID, Vitamin D (MANUFACTURER UNKNOWN) for unknown indication. Patient was allergic to penicillin and erythromycin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested positive for COVID-19 since having the vaccine. After vaccination on 11Mar2021, patient experienced throat tightness and numbness in left side tongue and cheek when she took Benadryl. Then patient went to urgent care center where benadryl kicked in and the patient started to feel better by the time doctor came in. The adverse event resulted in a visit to the Emergency room/department or urgent care. The clinical outcome of throat tightness and numbness in left side of tongue and cheek was reported as resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
47 2021-06-29 pain in extremity, myelitis transverse, involuntary muscle movements, numbness, tingling The patient experienced chest pain/heaviness in addition to interscapular stabbing pain radiating in... Read more
The patient experienced chest pain/heaviness in addition to interscapular stabbing pain radiating into both arms approximately 23 days following her second dose of the Pfizer vaccination. She was taken to the cardiac cath lab after negative troponins and a negative stress test. Two coronary stents were placed in the setting of single vessel disease. She suffered a mild myocardial infarct during angioplasty. The patient was transferred to the facility where I work due to persistance of bilateral arm/hand dysesthesias/numbness/tingling which did not resolve following angioplasty/stenting. She demonstrated a poorly-definted mid-thoracic sensory level described as abdominal numbness extending to the legs. She demonstrated widespread hyperreflexia, including crossed adduction with bilateral knee jerk reflexes. Her presentation was consistent with acute transverse myelitis. As of outpatient follow-up on 4/12/21 the patient had continued dysesthesias and a subjective sensory level similar to presentation.
47 2021-06-29 pain in extremity A couple of toes on both feet became painful, itchy and swollen; A couple of toes on both feet becam... Read more
A couple of toes on both feet became painful, itchy and swollen; A couple of toes on both feet became painful, itchy and swollen; A couple of toes on both feet became painful, itchy and swollen; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 47-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9264 and Expiration date was not reported) via an unspecified route of administration, in right arm, on 01Feb2021 at 10:30 AM (at the age of 47-year-old), as a single dose for COVID-19 immunization.The patient medical history included drug hypersensitivity (Sulfa allergy) and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 02Feb2021, patient had experienced a couple of toes on both feet became painful, itchy and swollen interfering with sleep and wearing shoes. No treatment was received. The outcome of the events was not recovered. The seriousness for the events was reported as non-serious. Follow-up attempts are completed. No further information is expected.
47 2021-06-29 pain in extremity get tested for COVID-19 on 21 March 2021. She said she got her result the following day, Monday, and... Read more
get tested for COVID-19 on 21 March 2021. She said she got her result the following day, Monday, and tested positive; couldn't swallow; stuffy nose/stuffy, runny nose and cough; stuffy nose/stuffy, runny nose and cough; stuffy nose/stuffy, runny nose and cough; general aches and pains; couldn't smell; couldn't breath; arm pain and felt tired/left arm pain, tender to touch; arm pain and felt tired/left arm pain, tender to touch; arm pain and felt tired/left arm pain, tender to touch; post-nasal drip; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6206), via an unspecified route of administration in left arm on 12Mar2021 at 15:30 (at the age of 47-year-old) as single dose for COVID-19 immunization. Patient got the Pfizer COVID19 vaccine because she wanted to be able to go to work and be around the kids. She states she wanted it for protection and that she wants her family to get it, so she wanted to be the first to go through with getting it. Medical history of the patient included heavy periods, anemia and allergies. Family Medical History included dad diabetic and both parents have heart issues and high blood pressure. Concomitant medications included iron, multivitamin, ergocalciferol (Vitamin D) and ascorbic acid (Vitamin C) daily, but patient declines to go through any details for the report, patient started taking Tranexamic Acid on 24Mar2021 and was ongoing [650mg one tab by month 3x day for first five days of menstrual cycle] due to history of heavy periods. The patient previously received her last shot and states maybe a tetanus shot or an epidural when she was pregnant. Also, mentioned that she doesn't get shots much. On 12Mar2021, after vaccination, by the time patient got home she was tired and took a nap. The patient experienced her arm was a little sore to the touch, when patient got home she put an icepack under her arm and took a nap. The patient stated she slept from about 19:30 until around 03:00 on 13Mar2021. Patient ate a bowl of cereal, took 2 extra strength Tylenol and went back to sleep until about noon on the 13Mar2021. When she woke up her tiredness was gone on 13Mar2021. As per patient Tylenol she took was effective. The patient stated that over the course of the weekend, she took 2 extra strength Tylenol twice and does feel like it was effective. The patient stated that her arm soreness was resolved by 16Mar2021. The patient reported that she could not smell since the 14Mar2021 which she attributed to her stuffy nose. On 15Mar2021 she started to get a stuffy, runny nose and cough, she attributed it to her allergies and change in weather, she normally has allergies. She went to work, she felt fine. Patient took some Allegra and her multivitamin. Patient stated from 15Mar2021, she was experiencing general aches and pains in her shoulders and back of neck. Patient was not sure if it was from her sitting at her desk at work or from the COVID19 virus. The patient had these aches prior to testing positive for COVID or even getting the Pfizer COVID19 vaccine, but she thought that it may be exacerbated by all of this. On 18Mar2021, the patient had worst day for her symptoms, stating she couldn't breath, couldn't smell, couldn't swallow. On 18Mar2021, she called her doctor. Her doctor prescribed her a zpack and Singulair for at night and a nasal spray. The patient felt like these were effective stating Z packs always work and make patient feel better, it was working. Patient explained that around the "15,16,17" Mar2021, she felt like "allergy" symptoms. She described them as a "loss of [her] sense of smell which she attributed to of [her] difficulty breathing; stuffy nose; and post-nasal drip". During this time she was still going to work. She notes that between the 14Mar2021-18Mar2021 she couldn't smell but she attributed this to the stuffy nose. She could smell fine now. Patient mentioned that her son started to get runny nose and cough symptoms, so she decided to go and get tested along with her son on 21Mar2021. Patient had a PCR test and following day, Monday, it came back positive. The patient was told to quarantine for 10 days since the onset of the symptoms. Patient would mean her quarantine was up on the 28Mar2021 or 29Mar2021, but she states she will probably continue quarantining until the 31Mar2021.The patient stated she was scheduled for her second Pfizer COVID19 vaccine on 30Mar2021, but she canceled it due to her positive COVID19 status and she doesn't think she should get the shot one day after getting out of quarantine. The patient doctor told her that she should wait 30 days to get her next vaccine which would be 18Apr2021 or 19Apr2021 but the doctor at the Urgent care told her she should wait 90 days. Patient asked what she should do. Patient does live with her son who developed symptoms after patient; both tested positive for COVID 19. Treatment included 2 extra strength Tylenol, allegra, zpack and Singulair for at night and a nasal spray. Outcome of the events arm pain, tender to touch was resolved on 16Mar2021, tiredness was resolved on 13Mar2021, couldn't smell, couldn't breath was resolved on 18Mar2021, for stuffy nose/stuffy, runny nose and cough, general aches while pain were not resolved and for COVID and couldn't swallow was unknown. No follow-up attempts are possible. No further information about lot/batch number cannot be obtained.
47 2021-06-30 weakness Lose sight in my left eye; Weakness; Heaviness in my legs/feet; Chills; Low grade fever; Neuoromyeli... Read more
Lose sight in my left eye; Weakness; Heaviness in my legs/feet; Chills; Low grade fever; Neuoromyelitis Optica; This is a spontaneous report from a contactable consumer (patient). A 47-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8729, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 08Apr2021 at 10:00 as dose 2, single (at the age of 47-years-old) for covid-19 immunisation. Medical history included vitiligo and known allergies to some raw fruits & vegetables and known allergies to penicillin. Patient received no other vaccines in four weeks. Concomitant medications or other medications in two weeks included pantoprazole, pimecrolimus (Elidel) and boron, calcium, Cimicifuga racemosa extract, folic acid, glycine max extract, Magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin B12 NOS (Estroven). Patient was not diagnosed with COVID prior vaccination. Historical vaccination included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7534, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 18Mar2021at 09:30 hours as dose 1, single for covid-19 immunisation and had no reaction on previous exposure to drug. Patient was COVID tested post vaccination by nasal swab and result was negative. On 09Apr2021 (the day after the second dose), patient had chills, low grade fever. On 13Apr2021 (4 days after the second dose, patient began to had weakness and heaviness in her legs/feet and by 16Apr2021, patient began to lose sight in her left eye and had to be hospitalized for a week. Patient received high dose of steroids and had to have plasma exchange (plasmapheresis) for an antibody (Neuoromyelitis Optica) that was triggered in her system, as treatment for all the events. Patient had doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Event lose sight in her left eye was considered as serious (hospitalization and disability) by the reporter. The outcome of all the event was recovering.
47 2021-06-30 flushing Gums started swelling; lips got tingly; My hands, feet, tongue, and my face got red and flushed; My ... Read more
Gums started swelling; lips got tingly; My hands, feet, tongue, and my face got red and flushed; My hands, feet, tongue, and my face got red and flushed; My hands, feet, tongue, and my face got red and flushed; stretching of her throat; felt dry; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW 0162), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 at 10:28 (at the age of 47-years-old) as single dose for COVID-19 immunization at doctor's office/urgent care facility. Medical history included seizures, migraines and allergy to Anti-Fungal Medications. Concomitant medication(s) included sumatriptan succinate (IMITREX); calcium; lamotrigine (LAMICTAL), and multivitamin, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 17Apr2021 at 10:45, reaction started with stretching of her throat and felt dry. She drank some water. At 11:00 gums started swelling and her lips got tingly. Her hands, feet, tongue, and face got red and flushed. She was sent to the ER for observation. Since then she had been on 6 rounds of steroids to try to control the reactions. She had 7 additional reactions within the 9 weeks after the vaccine. She was still on 40 mg of Zyrtec and Pepcid a day to keep down the reaction. She has been to multiple doctors and nobody could figure what the vaccine did to her system. She asked to help her to stop these reactions. Seriousness criteria was reported as Disabling/Incapacitating. Events resulted visit to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Received treatment for the adverse event with Benadryl, Zyrtec, Steroids', and Pepcid. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.
47 2021-07-01 migraine, tension headache severe burnt sensation on ceiling of mouth, indescribable entire jaws/teeth pain, itchiness, the mos... Read more
severe burnt sensation on ceiling of mouth, indescribable entire jaws/teeth pain, itchiness, the most severe migraine pain reaching level 100, intense severe tight neck, stiff neck, brain pressure, back of the head tightness, uncontrollable fatigue, lethargy, temple headache, ear clogging, severe inflammation type of swelling on right neck from 6/1/21 to present and ongoing, still sick as of 7/2/21.
47 2021-07-01 pain in extremity It started when I lifted my arms to change my cloths I felt pain on the back of my upper arms, the p... Read more
It started when I lifted my arms to change my cloths I felt pain on the back of my upper arms, the pain has been growing and now , is extending to my legs and my whole body
47 2021-07-01 pain in extremity Arm was sore for hours after, and the next day I started having tightness in my chest, and it stayed... Read more
Arm was sore for hours after, and the next day I started having tightness in my chest, and it stayed for two days and three days after vaccine My chest was tight all day. I did have Covid back in September of 2020
47 2021-07-01 tingling Approximately 5 minutes after the 15-minute waiting period after the shot, the left side of my entir... Read more
Approximately 5 minutes after the 15-minute waiting period after the shot, the left side of my entire body had intense tingling - from my head to my feet. My throat began to constrict making my breathing sound like a snore. This lasted for approximately 30 minutes, then completely subsided.
47 2021-07-02 breast pain Pinching pain on injection side, including left breast that radiates to left shoulder blade for more... Read more
Pinching pain on injection side, including left breast that radiates to left shoulder blade for more than 2 weeks.
47 2021-07-02 flushing Swollen lymph nodes on right front/ side of neck; Very tender lymph nodes on right front/side of nec... Read more
Swollen lymph nodes on right front/ side of neck; Very tender lymph nodes on right front/side of neck; Facial flushing on third day; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration in right arm on 19Mar2021 at 09:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune thyroid. The patient had no allergies to medications, food, or other products, but she had issues breaking down histamine so environmental triggers could cause allergic-like reactions. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had taken other medication (unspecified) in two weeks, prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 and procedures included the Nasal Swab test in Dec2020, the result was negative. On 22Mar2021 at 09:30, the patient experienced facial flushing on third day and on 24Mar2021 the patient experienced swollen/ very tender lymph nodes on right front/side of neck on fifth day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for the event. The clinical outcome of facial flushing, lymphadenopathy and lymph node tender were not recovered. No follow-up attempts are needed. No further information is expected.
47 2021-07-04 pain in extremity Dizziness Tired first 30 minutes. Fever sore arm 5 hours later. Next day felt the same fever tired ... Read more
Dizziness Tired first 30 minutes. Fever sore arm 5 hours later. Next day felt the same fever tired sore arm under armpit
47 2021-07-05 cold sweat, tremor During monitoring period 5 minutes post Pfizer COVID-19 vaccine, pt experienced nausea, clammy skin,... Read more
During monitoring period 5 minutes post Pfizer COVID-19 vaccine, pt experienced nausea, clammy skin, lightheadedness, dizziness (slow/sluggish), body tremors, fainted x 3 seconds. VS: 112/67, P 50, O2 on RA 96%. Pupils slightly enlarged. Patient arousable after 3 seconds Oriented x 4, pale. Patient states she does not take any medications normally and BP runs in 110s/70s. BP rechecked after -5 minutes 106/67, P 56, O2 on RA 98%. VS rechecked in other arm (L) BP 98/67, HR 50, patient placed in trendelenberg, ice applied, still somewhat nauseous.-15 minutes: BP 108/68, P 60, O2 on RA 98%, color returning to face, nausea lessened, still sweaty. -25 minutes: BP 109/72, P 60, O2 on RA 98%. After an hour and 30 minutes in Observation, patient was sitting upright in chair, stated she felt much better, no nausea, lightheadedness or dizziness, therefore, she decided to leave the clinic in the care of her family.
47 2021-07-06 weakness Fatigue the next day, then extreme joint pain, extreme headache, difficulty in breathing, foggy feel... Read more
Fatigue the next day, then extreme joint pain, extreme headache, difficulty in breathing, foggy feeling in brain, allergy symptoms, weakness
47 2021-07-08 difficulty speaking My father was with me and drove me over there. I got the shot. Around 12PM I started vomiting and I ... Read more
My father was with me and drove me over there. I got the shot. Around 12PM I started vomiting and I hadn't even ate anything, non-stop until two days ago. Diarrhea not able to keep anything down. My lymph nodes are swollen, my voice is very horse. Yesterday I was able to eat solid food very slowly. It reactivated my Epstein-Barre virus. I'm exhausted. From June 26th to July 7th those have been all my symptoms. On July 8th I was able to hold my food and water without throwing up but I still have diarrhea. I'm still fully activated with EBV and no disease doctor or primary doctor.
47 2021-07-08 pain in extremity Has a strong pain in arm; The patient feels her arm is swollen; patient still doesn't have full rang... Read more
Has a strong pain in arm; The patient feels her arm is swollen; patient still doesn't have full range of motion in her arm; Had a fever 15 minutes after getting home, after receiving the first dose Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable Pharmacist. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot number: EW0181; Expiration Date: Aug2021) via an unspecified route of administration, administered in left arm on 15Jun2021 as dose 1, single for COVID-19 immunization (age at vaccination: 47 years). The patient's medical history and concomitant medications were not reported. On 15Jun2021, patient had fever 15 minutes after getting home, after receiving the first dose Pfizer Covid 19. On an unspecified date, patient experienced a strong pain in arm and felt her arm was swollen and the patient still did not have full range of motion in her arm. The patient was saying she cannot return to work. The patient took two Tylenol and the fever has continued since. Patient received the treatment for pain in arm and pyrexia, and outcome of this event was not resolved. The outcome of swollen arm and joint range of motion decreased was unknown. No further information was reported.
47 2021-07-09 numbness, tingling Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Hypertension-Medium, Sy... Read more
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: pt felt numb on left side of cheeck, then radiate as tingling sensation on tongue and lip. blood pressure was going up.
47 2021-07-10 pain in extremity Patient reports 4 out of 10 - 7 out of 10 pain in upper left leg that radiates towards groin
47 2021-07-11 weakness I experienced pain and swelling of the lymph nodes in the right arm, nausea, loose stool, no energy... Read more
I experienced pain and swelling of the lymph nodes in the right arm, nausea, loose stool, no energy, body aches, and a low grade fever (101.0). I did not seek medical care and took Benadryl and Tylenol for my symptoms.
47 2021-07-11 electric shock sensation, numbness extreme electric shocks down both arms and legs; racing heartbeat/High heart rate; stomach pain and ... Read more
extreme electric shocks down both arms and legs; racing heartbeat/High heart rate; stomach pain and contractions; involuntary muscle contractions of hands so extreme I couldn't move them; involuntary muscle contractions of hands so extreme I couldn't move them; Chills; itching; numbness in hands and feet; High blood pressure; felt dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER2613) via an unspecified route of administration in left arm on 22Mar2021 at 12:00 (age at vaccination 47-year-old) as 1st dose, single for covid-19 immunization at Health Clinic/ facility. Patient medical history included allergies, asthma, reflux, osteopenia. Patient was allergic to Chickpeas, adhesives. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, at 12:15 patient Immediately felt dizzy and nauseous. Sat for 15 mins and felt a bit better, but off. Within 5 mins of driving experienced extreme electric shocks down both arms and legs, racing heartbeat, stomach pain and contractions, and involuntary muscle contractions of hands so extreme that she could not move them. Rushed to emergency room by ambulance. Chills and itching occurred, numbness in hands and feet. High blood pressure and heart rate. Adverse events resulted into Emergency room/department or urgent care. Treatment given for adverse event was 50 mg of Benadryl which did nothing, added IV of. Fluids and Pepcid, lidocaine with Maalox. Stayed over four hours before anything helped. Still having symptoms on day of reporting. The patient underwent lab tests and procedures which included blood test: unknown on 22Mar2021, electrocardiogram: unknown on 22Mar2021. The outcome of the events was not recovered at the time of reporting. No follow-up attempts are possible. No further information is expected.
47 2021-07-11 facial paralysis, facial pain, bell's palsy June 10 2021, I got up and I saw that my face was drooping. As the day progressed I saw that it was ... Read more
June 10 2021, I got up and I saw that my face was drooping. As the day progressed I saw that it was even worse so I went to the emergency room. I was diagnosed with Bell?s Palsy. I was prescribed steroids and antiviral medicine. It?s been a month and I am still unable to work. I look horrible. The pain of my neck head and face were unbearable.
47 2021-07-11 facial paralysis, face paralysis A few minutes after the vaccine, I was talking normally and relaxed and then suddenly had a strange ... Read more
A few minutes after the vaccine, I was talking normally and relaxed and then suddenly had a strange sensation on one side of my face. The right side of my mouth and right eye and cheek felt strange, like a sudden muscle cramp in my face. I was with my daughter and asked her if my face looked funny and tried to smile and she noticed one side (my right side) wasn?t smiling. I got dizzy and nauseous and had to lie down. Clinic staff brought sprite and crackers. After about 30 minutes I was able to sit up and the facial weakness started to subside. However, I continue 5 months later to have occasional facial weakness and eyelid twitching on the right side. It comes and goes. The weakness is gradually improving, but after seeing the story about the J&J vaccine, although I had Pfizer, I thought I should report this.
47 2021-07-11 numbness After the second shot, She experienced a sharp pain at the injection site as well as numbness throug... Read more
After the second shot, She experienced a sharp pain at the injection site as well as numbness throughout her entire arm to fingertips. It began to get more intense. She took tylenol and other over the counter pain medication without any improvement. She went to the emergency room on 7/5/2021 and urgent care 7/6/2021 due to unbearable pain and numbness. She was prescribed gabapentin 300mg which she takes 2 capsules 3x daily but seems to now built up a tolerance because it is only effective for about a few hours. She is not able to work or have any normalcy. We do not know what else to do. She needs assistance.
47 2021-07-11 numbness After an hour or so of my shot the left side of my face felt numb and was itchy. To explain the num... Read more
After an hour or so of my shot the left side of my face felt numb and was itchy. To explain the numbness it was like what your face feels like after getting your mouth numb to have dental work done. It lasted all day. The numbness has went away but still doesn't feel right. 3 days after my shot i got a severe sunburn on the arm I received my shot. I don't normally sunburn and I was under a tent most of the day.
47 2021-07-12 burning sensation, tingling Pins and needles down the arm and in hand/pins and needles in both hands and feet; Burning sensation... Read more
Pins and needles down the arm and in hand/pins and needles in both hands and feet; Burning sensation in palms of hands; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EWO180) via an unspecified route of administration in left arm on 08Jun2021 12:30 as dose 1, single (at the age of 47-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. Patient was not tested for COVID-19 post vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medical history was not reported and patient had no known allergies. The concomitant medications included calcium, colecalciferol (VIACTIV [CALCIUM;COLECALCIFEROL]) and vitamin once a day. On 08Jun2021 at 14:30 patient experienced pins and needles down the arm and in hand within 2 hours of receiving the shot (in the same arm that received the shot). The next day pins and needles in both hands and feet (including sometimes a burning sensation in palms of hands). This had been now for 2 weeks. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received bloodwork as a treatment for the adverse events. The outcome of the events was not recovered. Follow-up (28Jun2021): Follow-up attempts are completed. No further information is expected.
47 2021-07-12 cold sweat Chest tightening; Muscle Tightening; Nausea; Cold Sweats; Loss of Appetite; fatigue; headache; This ... Read more
Chest tightening; Muscle Tightening; Nausea; Cold Sweats; Loss of Appetite; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old, female patient received first dose of BNTI62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 23Mar2021 at 10:45 (at the age of 47-yeasr-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as high blood pressure, kidney and gallstones, depression, and bladder tumor. Concomitant medications were reported (unspecified drug). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 28Mar2021 at 05:00, the patient experienced chest tightening, headache, nausea, cold sweats, muscle tightening - type headache, loss of appetite and fatigue. The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chest tightening, headache, nausea, cold sweats, muscle tightening, loss of appetite and fatigue was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
47 2021-07-12 muscle twitching 6/30/21, 20 minutes after headache and fatigue. More tired that usual over next few days and hard to... Read more
6/30/21, 20 minutes after headache and fatigue. More tired that usual over next few days and hard to concentrate. 7/2/21-7/13/21 twitching in my legs upon waking (think activated bartonella bacteria from lyme co-infection), 7/3/21-7/8/21- circulation poor in lower legs-had to move around a lot, veins protruding from lower legs-which I've never had before and some swelling in ankles, feet and fingers, 7/1/21 heart beating fast going up flight of stairs but quickly went back to normal also got menstrual cycle 10 days early- was heavier with blood clots (typically 28 day cycle), bruise under area received vaccine
47 2021-07-12 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer. A 47-year-old non-pregnant femal... Read more
Sore arm; This is a spontaneous report from a contactable consumer. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via unspecified route of administration in the left arm on 05Mar2021 at 16:30 (at the age of 47-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via unspecified route of administration in the left arm on 26Mar2021(at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma. The patient was allergic to sulfas. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), naproxen sodium (ALEVE) and fexofenadine hydrochloride (ALLEGRA) from unknown dates, for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Mar2021, the patient experienced sore arm. The patient did not receive any treatment for the event sore arm. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event sore arm was resolved o an unspecified date. No follow-up attempts are needed. No further information is expected.
47 2021-07-12 tingling, numbness I had a fever of 103 after the 2nd dose that lasted for 2 days. Two days after the fever, my face ... Read more
I had a fever of 103 after the 2nd dose that lasted for 2 days. Two days after the fever, my face was slightly numb with a teary eye and runny nostril( I do not have allergies). 2-3 days after the numbness wore off, I felt tingling sensations in various parts of my body, particularly, my arms, legs, and face. The symptoms did not improve and I went to the emergency room because half my face was numb.(I did not receive treatment).The symptoms are still present almost two months later, however, not as severe.
47 2021-07-15 cold sweat, tingling, numbness, pain in extremity Minor reaction to the first vaccine included cold sweats, body aches, fatigue, and sore arm, which l... Read more
Minor reaction to the first vaccine included cold sweats, body aches, fatigue, and sore arm, which lasted approximately 3 days. Following the vaccine, I had a very light menstrual cycle which lasted only 2 days. Reactions after the second vaccine were similar but longer lasting and more intense. These reactions included a fever >100.0 for 5 days, body aches, extreme fatigue, and sore arm. After the second vaccine, I also experienced weakness in my legs, tingling or numbness in my legs that would come and go, and an inability to stand for more than a few minutes - which progressively got better, but lasted for about two weeks. In regards to my menstrual cycle, I skipped a cycle, had a light cycle, and had abdominal swelling until the end of the next full cycle. Since the second vaccine I have had two menstrual cycles, both of which were light, but each one becoming more typical of pre-vaccine menstrual cycles.
47 2021-07-15 numbness, tingling I had numbness and tingling, dizziness, and extreme fatigue for 5 weeks post injection. these are a... Read more
I had numbness and tingling, dizziness, and extreme fatigue for 5 weeks post injection. these are all Multiple Sclerosis symptoms that I battle with but not all at once and not in extremis.
47 2021-07-15 muscle spasms, tremor I have started having an involuntary, uncontrollable tremor/spasm in my right hand. It shakes and s... Read more
I have started having an involuntary, uncontrollable tremor/spasm in my right hand. It shakes and stops me from being able to control my hand or use my hand as I was (for instance, if I am writing, I usually have to wait out the tremor before continuing writing). It seems to be getting worse with time - with originally happening, maybe, once a day. Now it happens several times a day and throughout the night - even waking me, at times. I do not know if it is related, but I have developed a mild stutter, as well.
47 2021-07-15 tremor My period was 2 weeks late, which is not typical. Then, my POTS symptoms became much worse, making i... Read more
My period was 2 weeks late, which is not typical. Then, my POTS symptoms became much worse, making it feel like my beta blocker wasn't working. Symptoms include feeling dizzy, fatigued, headaches, shakiness, more adrenaline surges, rapid heartrate.
47 2021-07-16 feeling hot, speech disorder Incoherent dry mouth nausea headaches speech impaired could not walk chills hothead hyperventilating... Read more
Incoherent dry mouth nausea headaches speech impaired could not walk chills hothead hyperventilating and chest pressure
47 2021-07-17 weakness, feeling cold The next morning (about 16 hours later), I got really dizzy, then freezing cold. My temperature was ... Read more
The next morning (about 16 hours later), I got really dizzy, then freezing cold. My temperature was 103*F, and every single joint hurt so badly that I understood why people would cut body parts off from pain. I spent the day in bed, trying to listen to a book to distract me from the pain. I took Tylenol and ibuprofen alternately to try to keep the fever and pain under control. The extreme pain was gone about 12 hours after it started. I was still quite dizzy, but my temperature had dropped to 101*F the following day. I began sweating profusely, changing clothes 3-4 times a day due to the wetness of them. I was very tired, but after a week, my temperature dropped to 99.7*, and I was back to a 98.4* temperature after 2 full weeks post vaccination. The dizziness remained, however, when I bent over or tried to turn over. The sweating continued, but not when I just sat and did nothing. The slightest exertion would cause copious sweating though. The dizziness finally disappeared 6 weeks (to the day) after that second vaccine dose. The sweating, however, is still a problem 58 days later. I only have to change clothes 2-3 times a day now, but I have had to deal with the vaginal yeast infection, a fungal infection under my breasts, and now an infection between my toes that is quite painful, all because of the constant moistness of my sweaty skin.
47 2021-07-17 migraine, tension headache severe burning sensation of ceiling of mouth; severe pain on jaws/teeth; severe pain on jaws/teeth; ... Read more
severe burning sensation of ceiling of mouth; severe pain on jaws/teeth; severe pain on jaws/teeth; severe migraine; severe fatigue; lethargy; temple headache; severe tightness on the back of head; severe stiff neck; right ear clogging; swelling sensation of right neck; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient) reporting on herself. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EW0185) via an unspecified route of administration, administered in Arm Left on 15May2021 at 10:00 as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 at 10:00 (Batch/Lot Number: EW0171) as both for covid-19 immunisation. Medical history included drug hypersensitivity allergies Sulfa group, Band aids, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included acyclovir (400mg) taken for an unspecified indication, start and stop date were not reported. She was not diagnosed and tested Covid-19 prior vaccination. She was no pregnant at time of vaccination. On 01Jul2021 at 14:00 ,the patient experienced severe burning sensation of ceiling of mouth, severe pain on jaws/teeth, severe migraine, severe fatigue, temple headache, severe tightness on the back of head, severe stiff neck , right ear clogging, swelling sensation of right neck, dizziness. She went to emergency room. She was taken MethylPredisolone at two different times as a treatment for all events. Therapeutic measures were taken as a result of severe burning sensation of ceiling of mouth, severe pain on jaws/teeth, severe migraine, severe fatigue, lethargy, temple headache, severe tightness on the back of head, severe stiff neck, right ear clogging, swelling sensation of right neck, dizziness. The outcome of the events were not recovered. Follow-up attempts are possible. Further information is expected.
47 2021-07-17 tingling, cold extremities Immediate tingling (pins & needles)/ Over course of1 hour same symptom moved to add left hand, then ... Read more
Immediate tingling (pins & needles)/ Over course of1 hour same symptom moved to add left hand, then right and left foot.; Physical coldness (very cold) inright hand (all fingers).; Physical coldness (very cold) inright hand (all fingers). Over course of1 hour same symptom moved to addleft hand, then right and left foot.; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA165969) via an unspecified route of administration in the left arm on 20Mar2021 at 15:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to medications, food, or other products. Concomitant medications included unspecified antihistamine (MANUFACTURER UNKNOWN), and WAL-PHED D (MANUFACTURER UNKNOWN); both for an unknown indication and from on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 15:00, the patient experienced immediate tingling (pins & needles) and physical coldness (very cold) in right hand (all fingers). Over course of 1-hour, the same symptom moved to "add" left hand, then right and left foot. (Right hand symptoms longest and most intense and felt very similar to cortisone shot given for carpal tunnel syndrome). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events included oxygen & pulse check (Pulse Oximetry test). The clinical outcomes of the event tingling (pins & needles), physical coldness (finger cold) in right hand (all fingers), cold feet and hands (very cold) were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
47 2021-07-18 pain in extremity The next day(Friday) after my first Pfizer covid vaccination, in the evening around 7pm I started e... Read more
The next day(Friday) after my first Pfizer covid vaccination, in the evening around 7pm I started experiencing trouble breathing and pain in my right leg. I was also very tired. At first I thought it was a reaction to the medication. By Saturday, it was so bad I could not work more than few steps without feeling and breathing like I had ran a marathon. Monday I made an appointment with my doctor for the following Wednesday March 31. I also went for a Covid test Monday at a drive through. That test was negative. By Wednesday, it was so hard to walk into my doctor appoint. I was exteremely fatigued and out of breath. My legs no longer hurt though. My doctor took one look and sent me to the hospital for several tests. The tests determinted I had several small Pulminary embolisms (in my legs) including a saddle embolism which is very danger and a couple of larger clots in my right leg. I was admitted to the hospital and put on high doses of blood thinners. I have to take eloquis for an undeterminted amount of time and wear compression socks for the next two years. My doctor also told me not to get the 2nd Pfizer Covid vaccination. She and I both think that possibly the combination of my birth control and the vaccination caused the blood clots.
47 2021-07-19 pain in extremity June 25,2021 I developed severe left sided neck pain that radiating into my left shoulder and left ... Read more
June 25,2021 I developed severe left sided neck pain that radiating into my left shoulder and left arm. Then I woke up with left arm weakness on July 10,2021 that progressed to near loss of use of my left arm. I went to the ER on July 11, 2021 and I was diagnosed with Parsonage-Turner Syndrome. I had no preceding illness, no injury and I have tested negative to all autoimmune disorders.
47 2021-07-20 pain in extremity little gassy; I experienced severe abdominal cramping; A little soreness in arm; dose 2 administrati... Read more
little gassy; I experienced severe abdominal cramping; A little soreness in arm; dose 2 administration date 24Mar2021/dose 1 administration date 08Mar2021; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 13:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient did not report any medical history. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 08Mar2021 at 13:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient received dose 2 administration date 24Mar2021/dose 1 administration date 08Mar2021 (Inappropriate schedule of vaccine administered); the patient experienced a little soreness in arm but last night after shot approximately 10 hours after, the patient reported "I experienced severe abdominal cramping", on 24Mar2021. It lasted for several hours approximately 3 and then patient felt asleep. Woke up next day morning without cramps but a little gassy on 25Mar2021. The clinical outcome of the little soreness in arm and severe abdominal cramping and little gassy were unknown at the time of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Description as reported updated from "Inappropriate schedule of vaccine administered" to "dose 2 administration date 24Mar2021/dose 1 administration date 08Mar2021", Medication error checked in product details, Lead sentence updated as "non-contactable consumer", Final sentence updated.
47 2021-07-22 migraine over 45 days of extreme migraines with throwing up and diarrhea most of the day and night with a few... Read more
over 45 days of extreme migraines with throwing up and diarrhea most of the day and night with a few hours of reprieve out of 60 days in April and May, then about 15-20 days of migraines with same problems the following months I'm also taking about 3-4 Excedrin migraine tablets when I run out of Sumatriptan-which happens in about 4-5 days of migraines; I have to put a squishy, frozen ice pack under the base of my neck and take a nap in a blacked out room for 3-4 hours in about 70-72 degrees most afternoons; I have to wear my prescription sunglasses around the house and outdoors because the light hurts my eyes so much
47 2021-07-22 migraine 18 hours after receiving the vaccine, I had covid like symptoms. I was out of work for 2 weeks. I h... Read more
18 hours after receiving the vaccine, I had covid like symptoms. I was out of work for 2 weeks. I had a chronic headache and nauseas. At the end of April, we started having storms, and I felt like I was having a migraine headache crisis. This was the breaking point because I couldn't tolerate the pain anymore. I get injections for the nauseas and pain, but that was only good for 2 days. It feels like something is scrambling in my head. I have constant headaches, constant nausea, and constant fatigue. I'm currently under the care of a neurologist and my PCP. I haven't been in work since April 2021. I cant really do much now.
47 2021-07-23 weakness, tremor Within 5 minutes of getting vaccine pt felt dizzy, mild SOB, palpitations, throat itchy and scratchy... Read more
Within 5 minutes of getting vaccine pt felt dizzy, mild SOB, palpitations, throat itchy and scratchy, weak and numbness in tongue. Pt was given water and then epi-pen. Symptoms improved but still felt weak and dizzy and had some shaking. Pt transported to ER via ambulance
47 2021-07-23 numbness Within 10 minutes of administering the vaccine, the patient reported numbness in the left arm. Ther... Read more
Within 10 minutes of administering the vaccine, the patient reported numbness in the left arm. There was no pain or redness, but she reported that her arm felt numb. Advised the patient to take Tylenol or Ibuprofen and contact doctor if symptoms persist for more than 3 days. I called the patient 4 hours later and she reported that the numbness was gone and she was feeling better.
47 2021-07-23 pain in extremity I was scared. My arms hurt. I had chest palpitations and heart beating fast. I went to an urgent car... Read more
I was scared. My arms hurt. I had chest palpitations and heart beating fast. I went to an urgent care last week and my heart rate is still high and I don't like going to doctors so I am not doing too much. I am tired as hell all the time now. My appetite has changed and I don't eat as much.
47 2021-07-25 feeling hot Patient felt dizzy and hot; needed to lie down. Skin was clammy and BP was low.
47 2021-07-26 pain in extremity Arm soreness within an hour. That night severe stomach cramps, profuse sweating accompanied by diar... Read more
Arm soreness within an hour. That night severe stomach cramps, profuse sweating accompanied by diarhea and vomiting.
47 2021-07-27 weakness anaphylaxis/allergic reaction; Mast Cell Activation Syndrome; Drug Hypersensitivity Syndrome; Intole... Read more
anaphylaxis/allergic reaction; Mast Cell Activation Syndrome; Drug Hypersensitivity Syndrome; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left at age of 47 years, not pregnant on 19Mar2021 14:00 (Lot Number: Pfizerep7534) as single dose for covid-19 immunisation. Medical history included allergies to penicillin prior to vaccine and traumatic brain injury from near fatal accident. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control; fluticasone propionate (XHANCE). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had an anaphylaxis/allergic reaction to the first Covid Pfizer vaccine shot, (her only shot) on 19Mar2021 and since then things had spiraled out of control with her body; many medications to treat had caused more anaphylaxis allergic reactions like Benadryl, Cromolyn and Famotidine/Pepcid (7meds in total as she had been on no new meds since). She presented with Mast Cell Activation Syndrome and Drug Hypersensitivity Syndrome. 5 ER visits, 2 hospital stays and no improvements. The only medications that seem to provide any relief. Hydroxyzine, Singulair and Prednisone and even with these medications she continue to have allergic reactions or intolerances to medications which has now expanded to food, exertion, scents, and temperature changes. Not sure why this was happening, as prior to 19Mar2021 no food allergies and never had anaphylaxis until then. Patient in need of treatment by a vaccine expert. Her body saw everything as a toxin. Adverse event started at 19Mar2021, 14:00, and resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Hospitalization for 7 days. This case was serious with seriousness criteria reported as life threatening and caused hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid test via nasal swab on 12May2021 was negative. The outcome of the events was not recovered.
47 2021-07-27 electric shock sensation "an electric shock down her left arm"; she's been having heart palpitations; it is scary; This is a ... Read more
"an electric shock down her left arm"; she's been having heart palpitations; it is scary; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 13Jun2021 as single dose for Covid-19 immunisation. The patient's medical history and medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 Immunization. The patient experienced ‘An electric shock down her left arm, she's been having heart palpitations on, it is scary on Jun2021. There was no Investigation Assessment. There were no Prior vaccinations within 4 weeks. Reporter asked, "Okay, can I ask you a question. Okay, well done, I am looking for a cardiologist to see me because that palpitation I don't like it. It happens when I was reading my book and when I was washing tv and its scary. So, I need to speak to somebody. So, please." Consumer was informed about the Pfizer medical information department. The outcome for all the events was unknown. Information on lot/batch number has been requested.
47 2021-07-27 feeling hot Feeling hot; Loud high pitched ringing in ears; Extreme pain in joints-caused severe pain from lumba... Read more
Feeling hot; Loud high pitched ringing in ears; Extreme pain in joints-caused severe pain from lumbar surgical site to return,; Vomiting; Extreme exhaustion; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 28Apr2021 at 11:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis, multiple disabling back conditions with surgeries and rheumatoid arthritis. The patient received other medications within two weeks of vaccination. Past drug history includes sulfa and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 14:00 the patient experienced vomiting, extreme exhaustion, felt hot, fever, extreme pain in joints-caused severe pain from lumbar surgical site to return, headache and loud high-pitched ringing in ears. The clinical outcome of the events vomiting, extreme exhaustion, felt hot, fever, extreme pain in joints-caused severe pain from lumbar surgical site to return, headache, loud high pitched ringing in ears were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-07-27 feeling hot Left eye is swollen and painful and watery; Left eye is swollen and painful and watery; Left eye is ... Read more
Left eye is swollen and painful and watery; Left eye is swollen and painful and watery; Left eye is swollen and painful and watery; arm is swollen; feels hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old-non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 at 18:00 (at the age of 47-year-old) as a single dose for COVID -19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Apr2021 at 08:00, the patient's left eye was swollen and painful and watery. The patient's arm was swollen and felt hot to touch. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events left eye swollen and painful and watery, arm was swollen and felt hot to the touch were not recovered. No follow-up attempts are needed; information about lot number cannot be obtained.
47 2021-07-27 pain in extremity Headache; Feeling unwell; sore arm; Dizziness,; Nausea; Fatigue; Joint pain.; This is a spontaneous ... Read more
Headache; Feeling unwell; sore arm; Dizziness,; Nausea; Fatigue; Joint pain.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the left arm on 03Apr2021 at 16:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and allergy to formaldehyde(allergy to chemical). Concomitant medications included topical steroids (unspecified medication) for psoriatic lesions. The patient previously took cephalexin (KEFLEX), amoxicillin, clavulanic acid (AUGMENTIN), sulfamethoxazole, trimethoprim (BACTRIM) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 20:00 within four hours of vaccination, the patient experienced dizziness, nausea, fatigue and joint pain. On 04Apr2021 at 04:00 after 12 hours, the patient experienced headache, fatigue, feeling unwell and sore arm(pain in arm). The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events dizziness, nausea, fatigue, joint pain, headache, feeling unwell and sore arm were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-07-28 pain in extremity The injection site started to swell. Tips of the right fingers up to shoulder has pain.
47 2021-07-29 hot flush The night after I received the first Covid vaccine I started waking up every few hours in the nigh... Read more
The night after I received the first Covid vaccine I started waking up every few hours in the night all night long. The side effect went away after a few weeks. After the second dose on 7/25/21, the same thing started happening again. Additionally, I started experiencing what others describe as hot flashes. This is the first time I have ever experienced hot flashes.
48 2020-12-31 pain in extremity, burning sensation Extreme left arm pain, left arm burning pain, traveling pain up to the neck, headache, low grade te... Read more
Extreme left arm pain, left arm burning pain, traveling pain up to the neck, headache, low grade temperature for 3 day..left arm still very sore on day 4
48 2020-12-31 pain in extremity, slurring, weakness, feeling hot After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, the... Read more
After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, then I headache started. A minute later fatigue hit and I was starting to fall asleep at the wheel. I live 1 mile away so I made it home. Now my head was getting fuzzy. Called a co-worker to tell her what was happening and she said my speech was slurring. I felt drunk and hungover at the same time. I went to bed and slept for an hour. I woke up and felt very fatigued. I finally went to bed for the night then was awoken with severe arm pain. My entire upper arm felt so tight but I it was soft upon palpation. I fell asleep and awoke to terrible arm pain again. I started crying in bed but fell asleep again. I woke up in the morning with severe upper arm pain and minor headache. I couldn't rotate my arm back to put my bra on so I took some ibuprofen. That had immediate relief for my arm and headache. I ran one errand and was wiped out. The fatigue hit again. The arm pain came back so I took another ibuprofen with relief. I had no energy so laid around for the rest of the day. I woke up on Sunday and finally felt normal with just pain at the injection site. The 2 other medical people that have had similar reactions like mine with dizziness and feeling light-headed have one thing in common with me...we are all vegetarians. I don't know if that makes a difference with protein metabolism or other enzymatic activity, but we are the only 3 that I know of out of all of our co-workers who have received the vaccine to react like this.
48 2021-01-01 numbness Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset ... Read more
Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset 12/27. Visit to dentist for worsening pain and mild body aches and chills - dentist felt the pain and swelling, + mild ulceration due to new toothbrush head causing abrasions on gums and hard palate - no treatment prescribed - 12/28. Worsening painful lymphadenopathy (now bilateral cervical), body aches, chills, joint pain, fevers, odynophagia, gum pain/swelling, malaise - visit to respiratory clinic - rapid strep negative; COVID negative, bacterial throat culture negative (VS: HR 120, SBP 168, T 100.7 on Tylenol) - no treatment prescribed - 12/29. Development of shallow, painful ulcers LEFT hard palate, gums and a RIGHT lip ulcer - 12/31. Photos of ulcers reviewed with previous dentist - prescribed acyclovir 400 mg TID and magic mouthwash. 12/31. Taking Ibuprofen and Tylenol regularly. As of today, 1/2, improvement in cervical lymphadenopathy, resolution of constitutional symptoms, and odynophagia. Ongoing mouth pain and ulceration. + left facial numbness/burning pain (V1-3) similar to previous episode of trigeminal neuralgia in 1999.
48 2021-01-03 pain in extremity, muscle spasms Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula... Read more
Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; Pain remains 7/10 in shoulder blade and arm; Still do not have full AROM 23+ hours after injection; muscle spasms around left shoulder blade 4-5 hours later; 130 resting heart rate 6 hours after; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees/ Pain remains 7/10 in shoulder blade and arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular in the left arm on 21Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included partial motor seizures face. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE 40 mg), escitalopram oxalate (LEXAPRO 10 mg), brivaracetam (BRIVIACT, 100 mg). On 21Dec2020 4pm, within a couple hours severe pain in left arm at injection site and deltoid, muscle spasms around left shoulder blade 4-5 hours later, 130 resting heart rate 6 hours after, burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees. On 22Dec2020, by 9 am this morning back to 90 degrees shoulder flexion and abduction with pain. Pain remains 7/10 in shoulder blade and arm. Still do not have full AROM 23+ hours after injection. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel. Information regarding lot/batch number has been requested.
48 2021-01-03 pain in extremity dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, craw... Read more
dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, crawl; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; arm sore day #1 and #2- not unexpected; This is a spontaneous report from a contactable Physician(patient). A 48-year-old female patient received first dose (BNT162B2, lot number EK5730) , intramuscular at Arm Right on 18Dec2020 14:15 at the 48-year-old at single dose for COVID-19 immunization. The medical history included elevated blood pressure , allergic to sulfa, hypertension and Covid. The concomitant products included alprazolam, diphenhydramine hydrochloride (BENADRYL), spironolactone, metoprolol for hypertension, colecalciferol (VITAMIN D 3). The patient previously took nubaine and experienced drug allergy. The patient also happened to be a physician in private practice and received the vaccine at her local hospital. The patient had hypertension which was under excellent control on metoprolol 25 mg. She took it as prescribed every day surrounding the vaccine. On day #1 at the vaccine she felt like her heart may be racing 10 min after vaccine was about 80 on 18Dec2020 14:25. nothing serious. The patient experienced arm sore day #1 and #2 and not unexpected. On about 7 pm the day after the vaccine 19Dec2020 she was tachy at rate of about 105. She took her metoprolol heart rate never came down. At about 9:30 pm on 19Dec2020 when her rate should have been about70- she got up from couch after falling asleep. Upon standing felt like she was very dizzy. Walked upstairs, started to feel faint, perspiring, heart felt off beat and like blood not getting to my head. She had to get on hands and knees, crawl and heart rate was 142 and sustained for almost a minute. It took over an hour for it to come back to 86 and stayed there all night. There was not treatment to all of the adverse events. The outcome of the events was Recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the palpitations, tachycardia and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-01-03 tingling, flushing employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flush... Read more
employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flushing and ?"prickliness" on skin. no resp distress no swelling or rash seen. VS taken and hypertension noted 170s/90s. normal O2sat and HR- NO prior medical hx of hypertension. Monitored for 30 min in vaccination clinic persistent hypertension. Referred to ED for ongoing monitoring-still hypertensive but eval neg referred to primary care provider for follow up
48 2021-01-03 tingling 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreas... Read more
26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 25Dec2020 added facial edema; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; throat scratchy and tight; throat scratchy and tight; 23Dec2020 slight swelling on feet and ankles; 23Dec2020 slight swelling on feet and ankles; Tingling and best flutter 5 minutes after administration; Tingling and best flutter 5 minutes after administration; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number: EJ1685, expiration date: Mar2021), intramuscularly on 22Dec2020 at 09:45 at single dose for COVID-19 immunization in hospital. The patient medical history included known allergies: Sulfa, Penicillin; fibromyalgia; hypertension; high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included other medications was received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced on 22Dec2020 09:45 tingling and best flutter 5 minutes after administration; 23Dec2020 slight swelling on feet and ankles; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen, throat scratchy and tight; 25Dec2020 added facial edema; 26Dec2020 continued decreased perfusion added bilateral knee joint pain. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL) 50 mg every 6 hours. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: Flutter occurred 5 minutes after vaccination; a possible causal association between administration of the suspect vaccine bnt162b2 and the serious event onset cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-01-04 burning sensation, hypersensitivity of all senses I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity... Read more
I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity on my back (probably on 12/27, definitely by 12/28 progressing to waves of pain in my back to abdomen). On 12/30, a rash appeared on my abdomen starting below my navel and going around my left side to about an inch before my spine. I submitted a picture and it was diagnosed as shingles via a virtual visit. It is responding to antiviral therapy, although I still have a rash and pain (but improving). I did not go through the COVID vaccine side effect virtual visit route because I did not really think it was a side effect and knew I had a history of chicken pox and have been experiencing ongoing stress. The provider for the virtual visit told me to still report it for it to be investigated, but she too, thought it was likely unrelated, but still should be investigated.
48 2021-01-04 flushing 15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throa... Read more
15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throat irritation. She states she feels " a bit shaky inside ". Given juice and crackers. BP 143/84. heart rate 89. O2 sat 99%. She was moved into another quieter observation area. She claims she felt better. Given H20 to drink. States she had a bit of chest discomfort but this was nothing new to her. She has been having chest discomfort for the past 1-2 weeks periodically. Upon observing patient for 40 minutes, patient states, she felt better. BP 115/78, heart rate 80. Patient was then released. She states this is the first time this has happened while taking an IM injection.
48 2021-01-04 hot flush Headaches; Muscle pain; Low-grade fever; Body aches; Hot flashes; This is a spontaneous report from ... Read more
Headaches; Muscle pain; Low-grade fever; Body aches; Hot flashes; This is a spontaneous report from a contactable Nurse (patient herself). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via intramuscular, on 20Dec2020 at 18:15 at single dose for COVID-19 immunisation. Vaccine location was Arm Right. The patient was not pregnant. Relevant medical history included elevated rheumatoid factor, restless leg syndrome and depression. Past drug history included allergy to ferrous gluconate. Relevant concomitant medications included pramipexole dihydrochloride (MIRAPEX). The patient was vaccinated at hospital, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination COVID test was not performed. Post-vaccination COVID tests were performed: nasal swab on 28Dec2020 was negative; PCR in Dec2020 was negative. On 21Dec2020 at 18:30, the patient had headaches, muscle pain, body aches, low-grade fever and frequent hot flashes throughout the day at random moments, along with headaches and bod. The patient was not treated for the events. The patient had not recovered from the events.
48 2021-01-04 numbness, pain in extremity numbness left side of body including face, arm, leg pain left side of body in several places
48 2021-01-04 numbness numbness on left side of face, left arm and pain in different places on left side started for shortl... Read more
numbness on left side of face, left arm and pain in different places on left side started for shortly after vaccine. She has had all these symptoms prior but numbness never this bad. As of today, her symptoms are somewhat less. She has been able to work
48 2021-01-04 numbness numbness on left side of body including face, arm and leg Pain on left side in various places Starte... Read more
numbness on left side of body including face, arm and leg Pain on left side in various places Started soon after vaccine
48 2021-01-04 pain in extremity, discomfort, flushing Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly... Read more
Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later Headache waxes and wanes - at times feels like vice squeezing my head 11:50 heartburn sensation 12:00 localized swelling/ knot at injection site 12:04 wave of nausea/ mild heartburn Headache continues off and on 3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest 16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78 Hives for several hours. Hives gone by morning but still intermittently itchy. Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years) Very mild cough started in evening 12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache 22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists 12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on 9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97 12/21 Itchy/ hives on face, neck, upper chest By 12/21 afternoon, itchiness and hives abated. No further symptoms
48 2021-01-04 pain in extremity Sore Arm for 24 hours. Advil
48 2021-01-04 pain in extremity This caused immediate pain in the arm. The pain has continued for the past 20 hours.; This is a spon... Read more
This caused immediate pain in the arm. The pain has continued for the past 20 hours.; This is a spontaneous report from contactable Nurse reporting for herself via Pfizer Sales Representative. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #EJ1685), intramuscular into the right arm on 29Dec2020 11:15 at 0.6 mL, single for COVID-19 immunization. Medical history was none. There were no concomitant medications. The administer cleaned the arm with alcohol but didn't wait for it to dry. On 29Dec2020 the patient experienced immediate pain in the arm. The pain has continued for the past 20 hours. The outcome was recovered.
48 2021-01-04 tingling, numbness had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left s... Read more
had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left side of face; neck on left side felt like someone had hit it; injection site and whole deltoid was numb.; Left side of face, left foot and left ear all felt numb but with tingles; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0140), via an unspecified route of administration in Left arm on 28Dec2020 16:30 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at workplace clinic. Medical history included known allergies to food - vegetables, berries, shellfish, environmental. Concomitant medication in two weeks included desogestrel, ethinylestradiol (MIRCETTE), fluticasone propionate (FLONASE), iron, multi vitamin, elderberry w/z. The patient previously took benzoyl peroxide and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient waited 20min, went up to leave and while walking out had a little side step/unbalance moment. The patient thought nothing of it and went to car and was waiting in car for an extra 10 min. Her left hand started tingling, same tingling like if it was asleep and was waking up. Then she started to drive home, on the way home, noticed tingling in left foot and left side of face, neck on left side felt like someone had hit it. About 50 min after receiving injection, was at home, injection site and whole deltoid was numb. Left side of face, left foot and left ear all felt numb but with tingles. She had stopped timer after 2 hours. Tingling and numbness subsided sometime after 2 hours of receiving vaccine. Today (29Dec2020), everything felt fine. Injection site just felt like I got a shot, can barely notice it. Adverse event start date provided as 28Dec2020 05:15 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.
48 2021-01-04 tremor, weakness I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still fee... Read more
I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still feel like very weak and achy; Pain/achy/aches; Teeth chattering; Shaking all night long and 102 fever; Shaking all night long and 102 fever/low grade fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, reason for no lot number: consumer stated, "I can't even read, it says EK or E something 5730. That's what it looks like."), intramuscular in arm in Dec2020 at single dose for COVID-19 immunisation. Medical history included low thyroid, have had thyroid cancer many years ago. Concomitant medication included levothyroxine sodium (SYNTHROID). Consumer stated, "I just have a question, I had a shot done on Wednesday and I have heard the second shot was worst so I was little concern we are all concerned about getting the first shot to begin with. So I had the shot on 11:30 at work at the hospital on Wednesday. I probably about 1:30 to 2 O'clock in the morning total like flu side effect. I thought I got a flu, aches, pain, teeth chattering, shaking all night long and 102 fever. I haven't been sick at all thank god in a while but it feels like I had, so, I have a new born grandson supposed to go there for Christmas so I'm concerned because I was running a 102 Wednesday night and I was so running a low grade so is it normal to have reaction like that?" Consumer stated, "Yes, let me just get a pen. I just don't want to be around the baby. I thought I was fit but I don't usually when your body gets the vaccination your body fighting against the vaccine so I don't think it is going to affect the baby. I just don't want to get this shot if they got affected and if they are on fever. I just want to make sure before I go over there for Christmas." When probed if calling for the first time in Pfizer drug safety department, consumer stated, "No, actually I was just thinking now before I had out I grab these side effects yesterday and I read it I have fever 102, I was like let me call the number from the paper that they gave me with the shot card, let me call you guys and try to figure out what the hell is going on here and why I'm so freaking sick from this shit." .Height and weight: Consumer stated, "I say about 130 and about 5'6.". LOT#: Consumer stated, "Let me see if I have the card, I know I have it somewhere. May be I'm just thinking I shouldn't get the second shot. I can't even read. it's Pfizer, I can't even read, it says EK or E something 5730. That's what it looks like."Manufacturer name: Consumer stated, "Covid 19 Vaccine and I'm pretty sure it's Pfizer.".Lab work: Consumer stated, "I had all my labs on like you know like regular labs CBC's like everything. I have bad thyroid it goes up and down, I didn't feel well so I went to you know I know when my thyroid is up or down so I went and got the whole blood panel done.".Date of administration of first dose: Consumer stated, "It was probably like December 8th. I had it done on 23rd of December." (Not further clarified).Event date: Consumer stated, "The same day I had the shot.".When probed if still experiencing the events, Consumer stated, "Yes. It's not totally improved but it is better than it was but I still feel like very weak and achy." .Treatment: Consumer stated, "Tylenol and Ibuprofen I keep alternating it."Consumer stated, "I just want to make sure I can go back to my grandson today because I went to my daughter last time she is leaving for (place name) tomorrow and she was nervous and now I'm like still running a low grade fever last night and I know my daughter is going to flip out if I show up. I told her it's okay because it's only vaccination but I just want to make sure with the Covid shot I got." .The outcome of events I still feel like very weak and achy and pain/achy/aches was not recovered. The outcome of events flu / like flu side effect, teeth chattering, shaking all night long and 102 fever, shaking all night long and 102 fever/low grade fever, I'm so freaking sick was Recovering. The outcome of other events was unknown. Information on the lot/batch number has been requested.
48 2021-01-05 weakness Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested posi... Read more
Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020; Tested positive for COVID/positive via Nasal Swab test/fever/body aches/headaches/She was very very weak, almost lethargic/felt really bad/fatigued; gas; bloated; the weight last week she was 167 and this week she was 180; This is a spontaneous report from a contactable nurse reporting for herself. A 48-year-old female patient received her first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) Lot #EH9899, via an unspecified route of administration on 16Dec2020 at single dose by injection in the right deltoid for COVID-19 immunisation. Medical history included borderline hypertension from 2018 and ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) from 2018 and ongoing for borderline hypertension. The nurse reported that she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020. She said this kinda weird. She received the COVID vaccine on 16Dec2020. She tested positive for COVID on 24Dec2020. Obviously she was exposed to COVID prior to the vaccine. She was scheduled to have the 2nd dose on 05Jan2021 but her hospital deferred it to 23Mar2021. She was asking if this was what's recommended.She said this was another weird thing, regarding the weight last week she was 167 and this week she was 180 (in Dec2020). She was very bloated in Dec2020, it was bizarre. He husband did not receive the vaccine and had symptoms on 24Dec2020. She had normal seasonal allergy symptoms. She did not think much of it. She took her Xyzal and her normal things.She took her husband to get tested and he tested positive, so she got tested, and was positive. She worked at (address withheld), and all of her patients were immunocompromised. She was shocked. She did not think this had anything to do with the vaccine. If anything, it has helped her fight the virus.By Christmas day 25Dec2020 her fever was 102, she had body aches, she went into overdrive. She had headaches and lots of gas in Dec2020.She went into overdrive from partial recognition from the vaccine.She was very very weak, almost lethargic. Her O2 saturation have stayed good around 98% in Dec2020. She has done really well. Yesterday or the day before she felt really bad again. She did a virtual visit with (name withheld), and the doctor started her on steroids and gave her an inhaler just in case she needed it. She felt better on 30De2020. On 29De2020 she was so bad and bloated, she only had one dose of the steroids, but had unusual weight gain. Then 2 pounds were gone this morning on 30De2020.She had no pitting edema or edema period. She was very fatigued, but had more energy this morning, probably because of the steroids. She had the vaccine, even though day 7 post-injection, instead of day 10, which was about 50%, her body reacted more so than her husbands because her body recognized it. The outcome of the events was unknown. She was unsure of the outcome. It was up and down. She has felt worse and she has felt better. The reporter considered the event Tested positive for COVID was Not serious and unrelated to the BNT162B2.; Sender's Comments: While reporter causality is noted, a possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.
48 2021-01-05 feeling hot patient received vaccine and shortly became warm and felt her arms were getting red and splotchy. ... Read more
patient received vaccine and shortly became warm and felt her arms were getting red and splotchy. Patient taken to ER and was given PO Benadryl 50mg and observed. Discharged 2 hrs later
48 2021-01-05 flushing, night sweats fever 100 - 102, body aches, chills, sever nighttime sweating, intermittent nausea, severe headache... Read more
fever 100 - 102, body aches, chills, sever nighttime sweating, intermittent nausea, severe headache, fatigue, face feeling flush for 48hours beginning approximately 3 hours post second vaccination treated with acetaminophen, ibuprofen, fluids and rest
48 2021-01-05 flushing, tingling left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at... Read more
left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at emergency room 1330 symptoms increased. airway not obstructed. No tongue swelling reported by MD. Light red rash/flushing on chest. 25mg IV benadryl administered. IV Solumedrol administered, Vital signs stable. Cardiac monitor: regular rate and rhythm. O2 saturations 98% on room air. Symptoms improving at 1345pm. Monitored in emergency room for 1 hour. Discharged in stable condition with instructions to repeat Benadryl 8 hours after first dose if needed Throat fullness ( left side) with mild difficulty swallowing continued. Headache 5pm. Left sided face fullness/tingling: jaw, cheek. Left eye: mild swelling. 25 mg Po Benadryl taken. 01/06/21 0800 AM symptoms Left sided facial fullness/tingling continues: mild. No difficulty breathing. Left eye mild/yet decreased puffiness continues.
48 2021-01-05 flushing c/o headache 5 min after vaccine given initially 4-5/10 then decreased to 3-4/10. vital signs stable... Read more
c/o headache 5 min after vaccine given initially 4-5/10 then decreased to 3-4/10. vital signs stable 138/91 HR105 no rash, no redness, no induration at site. no resp distress. vital signs recheck 134/91 pulse 97 at 1233, advised to go to ER if symptoms worsened, discharged at 1638. Patient called clinic at 1330 on 1/6/21 c/o continued headache, now improving, Temp 99.2, facial flushing, bilateral arm and leg swelling also now improving. patient advised to go to urgent care or ER however patient refused and said she will go to her new primary MD on 1/8/21 and will go to ER if symptoms worsen. Also patient stated had COVID-19 test by occupational health results pending.
48 2021-01-05 numbness, tingling C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling i... Read more
C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling in nose, lips and mouth and eye lid swelling 12 hours after vaccine was given. Took Benadryl at 2230 and again at 12/29 0430. Called us to report s/s at 10:30 on 12/29. States symptoms are subsiding but still has eyelid swelling. Told to follow up with PCP.
48 2021-01-05 numbness Pfizer-Biotech COVID-19 Vaccine EUA Vaccine administered 12/30/20 1202 PM Starting 1/1/2021 - mild h... Read more
Pfizer-Biotech COVID-19 Vaccine EUA Vaccine administered 12/30/20 1202 PM Starting 1/1/2021 - mild headache, numbness in both hands but more significant in the left hand, left foot numbness.
48 2021-01-05 pain in extremity they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis s... Read more
they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis should not be a part of these trials; Never felt this kind of joint pain in my life/these are hitting my every joint in my hand, I can barely move; I have never been in as much pain in my life; I am really bad nauseous; soreness in your arm; This is a spontaneous report from a contactable consumer (patient) (Food service worker in the hospital). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history included Meniere's disease (reported 'Meniere's disease in my left ear'). The patient's concomitant medications were not reported. Consumer stated, ''I just took the COVID 19 vaccine I work at (institute name), (city name), I took it yesterday around 1 and all through the night; they suspect that I have rheumatoid arthritis I got an injection in one of my hips, my right hip and both my shoulders I can inject in cortisone injection and I have never felt this kind of joint pain in my life, I can barely move, I had been calling and I let my director know and anybody that has any kind of arthritis on these trials, I have never been in as much pain in my life and I am really bad nauseous.'' When offered for the website consumer stated, ''I just wanted to report the side effects, I am really nauseous and I can barely move; this is like abnormal I mean anybody with arthritis should not be a part of these trials.'' When probed if vaccine was prescribed by Physician, Consumer stated, ''No it was voluntary, it was not mandatory it was given my hospital administration.'' Product details for vaccine (LOT#, Expiration date, NDC#, UPC#): Consumer stated, ''EH9894, I think for the last number.'' Treatment for adverse events: Consumer stated, ''I don't have anything for nausea, I did take, they told to me take Ibuprofen my doctor said that it would help with the soreness in your arm, I take my Ibuprofen every six hours because it is prescribed to me, but I could barely move my, I can barely move; these are hitting my every joint in my hand.'' Expiry Date of Ibuprofen: 16Jul2021. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.
48 2021-01-05 pain in extremity Approximately, on day 6-7, left antecubital swelling and tenderness. Over next few days, gradual wor... Read more
Approximately, on day 6-7, left antecubital swelling and tenderness. Over next few days, gradual worsening pain and edema of the area and inner aspect of left upper extremity. Pain felt into the left axilla, Focal redness over ventral aspect of elbow. First, I did not relate it to vaccine and was not sure of etiology. Day 13: linear red indurated/ palpable ropy area , markedly tender in proximal forearm. Worse swelling and pain. Day 14: red Line extends upward towards axilla Day 15: Saw primary care physician Recommended antibiotics and Aspirin, warm compresses and ordered ultrasound. Findings were consistent with lymphadenitis and lymhpangitis
48 2021-01-05 tingling, flushing chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpit... Read more
chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpitations, no lightheadedness, no dizziness, no nausea or vomiting, no rash, no redness, no cough, no tongue swelling Started within 20-30 minutes of receiving the vaccine Received 25mg of Benadryl with improvement
48 2021-01-05 tingling, numbness After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness ... Read more
After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness in my right cheek/jaw and cold, numbness and tingling in my right hand/forearm. Symptoms improved within 24 hours and were gone in 48 hours.
48 2021-01-05 tingling Lightheadedness Tinlging in feet or head Given water and a snack; symptoms resolved. monitored for ... Read more
Lightheadedness Tinlging in feet or head Given water and a snack; symptoms resolved. monitored for 30 minutes.
48 2021-01-06 weakness, tremor, tingling On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 a... Read more
On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 am on 12-23-2020, the associate suffered from a severe headache 8/10, tingling sensation, BP checked Systolic in 180s, Extremely weak and tired, Severe nausea and dry heaving. Rapid response called, and associate was sent to ER. Headache 7/10. 1 gram Tylenol. Associate states ?Shaking, and I experienced delayed response when questioned by staff. 1 liter saline. Hives treated with Benedryl. In ER from 8am to 11:30am. It was determined that this was not an anaphylactic response. Associate went home with a headache 4/10. Groggy all day from Benedryl. I still have headaches constantly in frontal lobe. The headache pain Can rise from 2 / 10 to 8 /10. The constant headache is in the left frontal lobe. When the headache increases, It radiates into the temporal area as well. Dec 31, I went to Patient First. I was given Toradol IM, but the headache didn?t go away. I was given Flexeril, but it doesn?t help the pain. I am now using Excedrin to take the edge off. Associate is awaiting physician?s return call, but Dr. is out of town. Another doctor in the clinic would not see associate, as they don?t cover other physician?s patients. No fever, no respiratory symptoms.
48 2021-01-06 hot flush, tremor Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking... Read more
Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking, shivering, and pain in upper chest, which the patient described as being normal because of her COVID pneumonia. I would rate the reaction as moderate. Diphenhydramine 25mg capsule was given by mouth, ice water was offered. Patient was closely monitored but no further intervention was necessary. After about 25 minutes, symptoms subsided and patient decided to leave.
48 2021-01-06 numbness numbness left arm to elbow and left upper cheek, denies shortness of breath, denies itching, no rash... Read more
numbness left arm to elbow and left upper cheek, denies shortness of breath, denies itching, no rash noted, Initially refused Benadryl po instead requested to stay for observation for an additional 15minutes. Symptoms persisted, denies shortness of breath, ithcing, denies swelling of tongue, At 1500 Benadryl 25mg given po, patient stayed for observation for 15 minutes and was ready to leave at that time.
48 2021-01-06 numbness left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneousl... Read more
left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneously
48 2021-01-06 numbness and pain in extremities anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report... Read more
anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL0140) at single dose on left arm on 30Dec2020 at 09:00 for COVID-19 immunization. Medical history included asthma (controlled); hypertension diagnosis 1 year ago; allergies to medications, food and environmental. Concomitant medications in two weeks included antihypertensives - amlodipine and losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 9:15 AM, the patient experienced anaphylactic reaction within 10 minutes of administration, neuropathy in fingers, toes, roof of mouth/lips. Neuropathy continued to date. The adverse events resulted in emergency room/department or urgent care. The patient received treatment Epinephrine IM (intramuscular) and IV (intravenous) steroids. The outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of anaphylactic reaction and neuropathy peripheral due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase and nerve conduction studies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-01-06 pain in extremity Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chill... Read more
Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chills ,fever ( on Wed 6th pm) fatigue
48 2021-01-06 pain in extremity Sore arm and fatigue after 30 minutes; Sore arm and fatigue after 30 minutes; This is a spontaneous ... Read more
Sore arm and fatigue after 30 minutes; Sore arm and fatigue after 30 minutes; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm 02Jan2021 at 12:00 PM (at the age of 48-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, gastritis, and hypothyroidism. The patient had allergy to Sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine, formoterol fumarate, mometasone furoate (DULERA), salbutamol (ALBUTEROL HFA), omeprazole (PROTONIX), and alprazolam (XANAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jan2021, at 12:30 PM, the patient experienced sore arm and fatigue after 30 minutes. The events were reported as non-serious. The patient did not receive any treatment for the sore arm and fatigue after 30 minutes. The clinical outcome of the events sore arm and fatigue after 30 minutes was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
48 2021-01-07 weakness, pain in extremity Initial event was soreness at site which resolved on its own within a few days. 2 days after receiv... Read more
Initial event was soreness at site which resolved on its own within a few days. 2 days after receiving vaccine, I began having an allergy reaction to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed. I have been experiencing chills then profuse sweating. I also so fatigued, I sleep much of the day. I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.
48 2021-01-07 weakness Chills, generalized weakness, fatigue
48 2021-01-07 migraine, feeling cold, cold sweat about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going... Read more
about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going down if I didn't) cold clammy, nauseated, BP dropped, HR wnl, After about 20 mins, I felt fine. Went to work, did develop a migraine afterwards, some body ache and fatigue.
48 2021-01-07 migraine Sxs heart palpitations on 12/28/2020 and then 12/29/2020 migrane headache. Sxs persist. Improved b... Read more
Sxs heart palpitations on 12/28/2020 and then 12/29/2020 migrane headache. Sxs persist. Improved but with occasional palpitations.
48 2021-01-07 pain in extremity, tenderness Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, mala... Read more
Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, malaise, myalgia, dizziness.
48 2021-01-07 pain in extremity Patient describes sore arm,
48 2021-01-07 tingling I started feeling achy (body aches) at night and took Tylenol and the next day at work I started hav... Read more
I started feeling achy (body aches) at night and took Tylenol and the next day at work I started having abd pain, joint pain and headache, and at home I checked my temp and it was 100.8F and my heart rate was fast, my lungs felt tight and a Tylenol and the symptoms continued for another day and gradually went away with exception of my joint pains. I also had tingling on my arms, back of my head, legs and my neck. I went to a neurologist and an allergist . My PCP does not want to make a decision about whether or not I should have the second dose before I see those.
48 2021-01-07 seizure The patient reported shortness of breast and difficulty breathing. The patient's husband stated tha... Read more
The patient reported shortness of breast and difficulty breathing. The patient's husband stated that he witnessed the patient having a seizure. Patient advised to call EMS. EMS took the patient to hospital. The patient was stabilized after receiving emergency treatment.
48 2021-01-08 feeling cold Employee Health notified several days after first vaccination that she had a sore throat, felt cold,... Read more
Employee Health notified several days after first vaccination that she had a sore throat, felt cold, "brief asthma attack" one hour after being vaccinated. Did not seek medical care. Inhaler used and symptoms went away 15-20 minutes later.
48 2021-01-08 feeling hot, feeling cold, tremor, cold sweat, flushing Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " ... Read more
Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " I have asthma too too hard to tell the difference" Tearful, skin felt clammy.
48 2021-01-08 feeling jittery, flushing Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse s... Read more
Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse sweating. Within 30 minutes heart rate increased and a little clearing of throat. A little over an hour nausea started and increased clearing of throat , slight feel of constricture in throat and a slight feeling of heaviness in chest, and jittery and heart rate still feels increased. Nurse at Nursing home watched for 45minutes until I chose to leave. In my vehicle and home is when nausea started. Phone call contacts with nursing home staff continued for an hour. I took 2 benadryl and 2 Tylenol, napped. Felt better. Nausea 3 days. Tired and neck lymph achy.
48 2021-01-08 pain in extremity fever, chills, arm pain, muscle aches, severe headache,
48 2021-01-08 tingling Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter i... Read more
Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter in her chest shortly after vaccination done 12/22/20 (while being observed). States she informed staff, RNs in clinic state this employee did not report any reactions to clinic staff. Employee returned to work in ICU, states "felt better by end of day". 12/23/20 states swelling to both feet, reports 6+ (?) pitting edema. 12/24/20 states abdomen swollen. Called advice nurse who recommended she report to ED. Employee declined ED and took Benadryl instead. 12/26/20 states face swollen, joint pain, legs felt like they were on fire, could barely walk. 12/28/20 states feels better . Left foot a little swollen
48 2021-01-09 pain in extremity Received injection 1/8/2021 at 6:00 pm. 12 hours after injection experienced very sore arm, temp th... Read more
Received injection 1/8/2021 at 6:00 pm. 12 hours after injection experienced very sore arm, temp that peaked 101, aches and chills. Symptoms lasted about 15 hours. Upon waking on 1/10/2021 no fever, aches or chills. Sore arm continues.
48 2021-01-09 pain in extremity Woke up in middle of night with fever and chills and body aches. Arm very sore and hard to lift. T... Read more
Woke up in middle of night with fever and chills and body aches. Arm very sore and hard to lift. Tylenol taken with not too much relief. Slept most of the day. Second day arm is much better and can move more. Body is still achey.
48 2021-01-09 tingling Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach quea... Read more
Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach queasiness. HR was 156, sats were 100 % on room air. Seemed to subside after 30 minutes . However throughout the rest of the day, waves of similar symptoms recurred predominantly tachycardia and GI along with skin sensitivity. Overnight did ok, but the following morning, again re urged with sustained tachycardia at which time sought ED evaluation. Had one episode in ED with HR in 151, other vital signs maintained. Received solumedrol and Benadryl. After treatment and monitoring without recurrence, discharged home on prednisone , Benadryl. Ativan if needed.
48 2021-01-10 weakness, night sweats Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and... Read more
Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and fever, night sweats and spreading pain throughout the body. Also reporting weakness
48 2021-01-10 weakness Weakness, fatigue, fever to 101, chills, muscle aches, shivers, joint pain, severe headache, nausea,... Read more
Weakness, fatigue, fever to 101, chills, muscle aches, shivers, joint pain, severe headache, nausea, loss of appetite lasting approximately 72 hours
48 2021-01-10 feeling hot, nerve pain 6pm same day severe body ache, diarrhia, feeling chills/warmth. didn't take temp took Tylenol/Motrin... Read more
6pm same day severe body ache, diarrhia, feeling chills/warmth. didn't take temp took Tylenol/Motrin daily. s/s today left shoulder nerve pain (had injection on right side) 6/10. No body ache, diarrhea, chills today. COVID 1/8 test negative.
48 2021-01-10 flushing, numbness I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt sever... Read more
I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt severely and I felt my throat swelling, it became increasingly difficult to swallow. My tongue felt larger and my lips and face began to feel numb. I felt flushed and I became tachycardic. It lasted about 45 seconds and then waned and then would flare again. I was able to speak and called my husband (a physician) who stayed on the phone with me while I drove to the hospital. I went straight to an outpatient unit and was given hydrocortisone IV, loratidine PO and famotidine. By the time I was on the unit, my throat only felt slightly tight with tachycardia down to 103. Following the injection of steroids, I only had one further flare of throat tightness and tachycardia that was transient lasting 30-40 seconds. Everything resolved within 40 minutes of receiving therapy. Of note, I apparently had erythema on the anterior of my neck which corresponded to the area of throat tightness.
48 2021-01-10 numbness Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine... Read more
Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine, patient began experiencing nasal passage tightness, nasal congestion, and facial numbness. No wheezing, rash, visible swelling, tachycardia, or hypotensions. Given diphenhydramine, famotidine, and prednisone in emergency department. During observation in ED, started having throat and chest tightness with hyperventilation. This improved with lorazepam. Patient felt improved and was discharged with Epi pen and told to follow-up with her allergist.
48 2021-01-10 unresponsive to stimuli After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, an... Read more
After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, and "didn't feel right". Patient was laid flat on a couch, but then passed out and was not responsive to sternal rub. After a code was called, the patient woke up. At no time was there a loss of pulse or SOB. Patient was transported to the ER and was subsequently discharged same day. Patient did report that prior to the vaccination, she ran 13 miles in the morning, which may have had something to do with the reaction.
48 2021-01-11 weakness, numbness I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt littl... Read more
I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt little bit sick and I picked up food and I started to feel sick. I went to work and my symptoms got worse and I sat in my desk and I felt like fainting. I just felt so sick and I thought it was my diabetes. A coworker saw me and told me i looked deathly pale and felt fainting and they took me to a ER room. They gave me Benadryl and IV fluids. I started seeing the floor and ceiling warped out, I was hallucinating. My legs felt numb as well. My eyes were twitching constantly. My blood pressure 147/95 and pulse was 112. I went home, ate and went to sleep. On Saturday I felt better and went back to work 12-28-2020, I felt weak and stayed working at my shift. On Tuesday I worked 1 hour and still felt super weak. Today I am starting to feel like myself again. I will not get my second dosage due to my symptoms I have experienced.
48 2021-01-11 burning sensation Patient states that she felt the vaccine go through her body. She says that after about 20 minutes s... Read more
Patient states that she felt the vaccine go through her body. She says that after about 20 minutes she developed dizziness and throat tightness. She developed erythema across her chest. BP 180/108. O2 sats 98%. No SOB or difficulty breathing
48 2021-01-11 seizure Pt had a strong seizure
48 2021-01-12 weakness Dizziness, Nausea Vomiting, chills, shortness of breath, weakness. Symptoms lasted until 1/9, except... Read more
Dizziness, Nausea Vomiting, chills, shortness of breath, weakness. Symptoms lasted until 1/9, except on 1/11, still feels some SOB.
48 2021-01-12 burning sensation 2nd shot, 12 hrs after body aches; 24 hrs after fevers high 102.5; rigors; felt I was burning up; Th... Read more
2nd shot, 12 hrs after body aches; 24 hrs after fevers high 102.5; rigors; felt I was burning up; This is a spontaneous report from a contactable other healthcare professional reporting for herself (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) intramuscularly at Left arm on 05Jan2021 12:00 at SINGLE DOSE for COVID-19 immunization. Facility type vaccine was Hospital. Medical history included allergies to Sulfa, mild ragweed. Concomitant medication included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC ALLERGY), estradiol (VIVELLE DOT). The patient received the first dose of BNT162B2 vaccine (Lot number EK5730) via intramuscular route of administration in the right arm on 15Dec2020 at 12:30 at single dose for COVID-19 immunization. On 15Dec2020 at 12:30, the patient experienced warm feeling throughout body and heart race which lasted 10 seconds. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination she had not been tested for COVID-19. Adverse events reported as "2nd shot, 12 hrs after body aches, 24 hrs after fevers high 102.5, rigors and felt was burning up". Adverse event start date was reported as 06Jan2021 06:00AM. No treatment received for the events. Outcome of the events was recovered in Jan2021. Information about Batch/Lot number has been requested.
48 2021-01-12 facial pain, trigeminal neuralgia Episodic Severe facial pain, ? Trigeminal Neuralgia. ER visit with bloodwork. Office visit follow ... Read more
Episodic Severe facial pain, ? Trigeminal Neuralgia. ER visit with bloodwork. Office visit follow up. MRI pending
48 2021-01-12 migraine Fever 100 F Severe body aches Migraine type of headache Nausea and diarrhea All lasting 16 hours ... Read more
Fever 100 F Severe body aches Migraine type of headache Nausea and diarrhea All lasting 16 hours Still slight headache
48 2021-01-12 pain in extremity, tremor Woke up at 12:30 am with severe chills and shaking. Headache, muscle aches, sweating and sore arm
48 2021-01-12 pain in extremity Increased pain, URE/axilla swelling, intermittent shooting pain in URE starting on 1/12/2021 approx.... Read more
Increased pain, URE/axilla swelling, intermittent shooting pain in URE starting on 1/12/2021 approx. 1430, progressively worsened.
48 2021-01-12 tingling, flushing 11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observa... Read more
11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observation post vaccine. No symptoms during 30 minute observation post vaccine administration. Approximately 12:45pm right hand, tongue, mouth started tingling, and felt tongue was swelling. Reported feeling flush with chills, headache, and generalized weakness in legs. Went back to vaccine clinic to report symptoms at 2:15pm.
48 2021-01-12 tingling Systemic: Tingling sensation in injection arm, went away then noticed on other side of body in leg, ... Read more
Systemic: Tingling sensation in injection arm, went away then noticed on other side of body in leg, then spread to right arm. Described sensation as 'what it feels like when you sleep on your arm funny'.-Mild
48 2021-01-12 tenderness, weakness The vaccine was administered too high on the shoulder. Within 2 hours a report was made. symptoms w... Read more
The vaccine was administered too high on the shoulder. Within 2 hours a report was made. symptoms were pain, weakness, tenderness of shoulder joint and upper arm
48 2021-01-13 weakness Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covi... Read more
Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.
48 2021-01-13 flushing Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at... Read more
Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at the reaction since she is ex-military and had received a full complement of vaccine for overseas deployment with no issues.
48 2021-01-13 numbness Bilateral mild facial numbness. Intermittent. No weakness.
48 2021-01-13 tingling, flushing Facial Flushing, face tingling, tongue swelling, appx 5' after injection. transferred to ED & tx wi... Read more
Facial Flushing, face tingling, tongue swelling, appx 5' after injection. transferred to ED & tx with Benadryl, Pepcid. solumedrol IV. : with sx resolution - observed for 4 hrs in ED & d/cd
48 2021-01-13 tingling Reported heart rate of 108, a week of paresthesias. Symptoms resolved
48 2021-01-13 tingling Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experience... Read more
Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experienced lightheadedness, nausea, bilateral hand tingling, hypertension after administration of her first COVID vaccination. No airway involvement. No rash, chest pain or SOB. Patient states that she thinks she had COVID in March though she tested negative. Patient has never had prior vaccine reaction. She was taken to ED, given PEPCID IV and liter of LR. Her vitals were stable throughout and she felt back to baseline and was released to go home after about 2 hrs.
48 2021-01-13 tingling pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of ... Read more
pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of upper extremities/tingling; sore throat; shortness of breath; anxiety; malaise; This is a spontaneous report from a contactable Nurse (patient). A 48-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: EL1284), via an unspecified route of administration in left arm on 04Jan2021 05:15 at single dose for COVID-19 immunization. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient had no Known allergies. Concomitant medication included zinc, vitamin d3, quercetin and sambucus nigra (ELDERBERRY) received within 2 weeks of vaccination. The patient reported that 12 hours after the injection she experienced severe headache, nausea, chills, temp 102, tingling of upper extremities, sore throat, shortness of breath, pressure in her chest on 04Jan2021 17:15. The fever/chills lasted about 12hrs. Chest discomfort, tingling and shortness of breath were transient (possibly anxiety related). Day 2 post vaccine in Jan2021 moderate to severe HA (headache) persisted and malaise. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
48 2021-01-14 weakness Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday... Read more
Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday morning, I was aching all over and still had a headache. The aches were so severe that I was unable to tolerate anything or anybody touching me. By that afternoon, I was weak and fatigued. I was sent home by my director and by that evening I had developed a temp of 101.0. Friday morning, I was not feeling any better so I went to Urgent Care at around 0800. COVID test was negative but possibly too early to detect. Here we are today and I am still having body soreness that has become unbearable. I went to the walk-in clinic here at the hospital and have now been told that I will have to be admitted based on my lab results that indicates rhabdomyolysis.
48 2021-01-14 flushing, pain in extremity Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed... Read more
Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed at about 25 minutes. Feeling winded at about 30 minutes, lips very slightly blue-ish. Vitals were all normal and no treatment was given. Approx six hours later I experienced a "lump in my throat" for about two to three hours - took Benadryl, which resolved it. Also around five or six hours later ordinary side effects began - fatigue, aches, headache, sore arm. These all resolved by the following morning.
48 2021-01-14 muscle spasms GI issues, severe cramping, diarrhea >10/day , dehydration, headache, tired Normal activities affec... Read more
GI issues, severe cramping, diarrhea >10/day , dehydration, headache, tired Normal activities affected
48 2021-01-14 night sweats, pain in extremity day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, w... Read more
day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, woke up in wet clothes from sweat, headache, runny nose Day 3- sore arem, red and swollen, warm to touch, felt lethargic day 3- arm just red and warm to touch. big red circle where shot was given day 4- sitting down and out of nowhere a sharp pain felt in back by neck and shoulders. could not move my neck. arm still a little red but not warm to touch. swelling went down. (went to ER on day 4. blood work and xrays were negative for anything. was given muscle relaxer.) day 5 sore muscles but on muscle relaxer to help day 6 until day 10 - just fatigue and sore muscles/joint pain but tolerable.
48 2021-01-14 pain in extremity "the next day (1/8/21) i started with a low grade temp, it never got over 100.2, now i still have ex... Read more
"the next day (1/8/21) i started with a low grade temp, it never got over 100.2, now i still have extreme fatigue. My arm was sore for a couple of days only. The first vaccine was on 12/17/20 and i had 11 days of nausea afterwards"
48 2021-01-14 tingling, weakness severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness... Read more
severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness; fever; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), via Intramuscular at single dose in the arm left, first dose on 17Dec2020 08:15, second dose on 07Jan2021 08:15, both for COVID-19 immunisation. Medical history included Epilepsy. Concomitant medications included fluvoxamine maleate (LUVOX), oxcarbazepine (OXTELLAR XR), liraglutide (SAXENDA) and bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). On 07Jan2021 17:00, the patient experienced severe headache, severe nausea, severe vomiting, upper gi pain, tingling in hands and feet, weakness, fever. The patient underwent lab tests and procedures, which included Nasal Swab on 08Jan2021 with negative result. Therapeutic measures were taken as a result of severe nausea and severe vomiting and included treatment with Zofran. Outcome of events was recovering.
48 2021-01-14 tingling, numbness RRT called for numbness and tingling sensation report by patient (employee) after receiving Pfizer C... Read more
RRT called for numbness and tingling sensation report by patient (employee) after receiving Pfizer COVID-19 Vaccine. Vaccine administered at 10:48am and approximately 15 minutes later starting reporting numbness and tingling sensations. All VSS stable, neuro exam completed with no other findings appreciated. MDs at bedside encouraging patient to go to the emergency department but patient refused. Encouraged to go if symptoms persist and/or worsen. Patient endorses she will take Benadryl when she gets home.
48 2021-01-14 tingling Sévère arthralgia, not able to walk. Facial paresthésie. Extreme fatigue, chills and fever
48 2021-01-14 tingling Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a co... Read more
Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a contactable Physician (Patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231), via an unspecified route of administration on 07Jan2021 13:15 at single dose in Left arm for COVID-19 immunization. Medical history included hypothyroidism, breast cancer and severe local/regional reaction to bee sting. The patient previously took tamoxifen for breast cancer (9-10 years before 10Jan2021). There were no known allergies. Concomitant medications which the patient received within 2 weeks of vaccination included levothyroxine, tamoxifen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced uneasiness, tingling followed by tachycardia within couple of minutes, some abdominal queasiness on 07Jan2021 13:15. Heart rate (HR) was 156. Seemed to subside over a period of 30 minutes. However slow waves of similar episodes occurred throughout the rest of the day, predominantly tachycardia and Gastrointestinal tract. Next day symptoms recurred and sustained a little longer. Sought evaluation. In Emergency department (ED), Labs unremarkable. One episode in ED with HR 151. Blood pressure (BP) maintained. Electrocardiogram (EKG) showed sinus tachycardia. Treated with steroids and Benadryl. On pulse dose steroids and Benadryl with overall improvement. The events resulted in Emergency room/department or urgent care. Treatments Solumedrol and Benadryl were received for the reported events. The outcome of the events was Recovering. This case reported as non-serious.
48 2021-01-14 tingling At 6 pm I started feeling tingling/prickly sensations around my body in different areas lasting abou... Read more
At 6 pm I started feeling tingling/prickly sensations around my body in different areas lasting about 1 sec each time.
48 2021-01-14 tremor "11p that night I had a 101 -102 temp, chills, headache, hard shakes"
48 2021-01-15 difficulty speaking About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it ... Read more
About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it was deep and scratchy, The change in voice got worse as i was speaking to my friend so i went to the ED (building next to where I work). I had no problems breathing but was eventually treated for anaphylaxis with epi, prednisone, benadryl, and pepcid
48 2021-01-15 pain in extremity I have chronic neck pain that flared up pain level (4-6 on a 1-10 scale) that lasted 4 weeks. I exp ... Read more
I have chronic neck pain that flared up pain level (4-6 on a 1-10 scale) that lasted 4 weeks. I exp other side effects body aches, joint pain, nausea, sore arm.
48 2021-01-15 tingling L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation res... Read more
L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation resolved following benadryl. tingling still present at 14 hours but has improved.
48 2021-01-16 flushing, hot flush Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, t... Read more
Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, tachycardia.
48 2021-01-16 hot flush Lips tingling, tongue/throat swelling, flushed, hot flashes, leg weakness, nausea, tachypnea
48 2021-01-16 pain in extremity Temperature 102 Fatigue Sore arm Chills
48 2021-01-16 tingling, weakness Dizzy, weakness, tingling in lips and fingers, increased heart rate
48 2021-01-17 burning sensation On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell an... Read more
On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell and neck was red and had small bumps on it. Took some Benadryl and went to bed woke up this morning and eyes were swollen and face was a little worse. No record that patient sought medical attention or visited the ED. Patient reported swelling and itching went resolved the weekend of 1/16/21.
48 2021-01-17 difficulty speaking Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, ... Read more
Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, throat swelling and hoarse voice. Symptoms started approximately 40 minutes post vaccination at 1320. Pt has hx of food allergies. Pt was treated with epinephrine 0.3mg IM, diphenhydramine 25mg po, and famotidine 20mg po and prednisone 40mg PO. Observed in ED until 1758 and was noted to have no worsening of symptoms and improvement in hoarse voice. Discharged with prescription for prednisone 40mg x4 days.
48 2021-01-17 feeling cold Chills, muscle pain, tiredness, injection site pain, feeling malaise
48 2021-01-17 flushing On 1/14/21 I took ibuprofen at 400. By 9am I was starting to feel achy and had chills. The... Read more
On 1/14/21 I took ibuprofen at 400. By 9am I was starting to feel achy and had chills. The symptoms progressed throughout the day. I felt feverish and the symptoms worsened. Chills, flush, all over body aches including headache. I went to buy some ibuprofen since I forgot to bring any with me. I felt better after I took the medicine.
48 2021-01-17 numbness The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went ... Read more
The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went numb, and I became a little bit disoriented while driving home. I also noted a pain in the left side of my chest. I got feeling back in my lips in my face approximately half an hour to 45 minutes later. I did take an Allegra allergy pill when I got home. I had already taken one Allegra allergy pill that morning. I slept for 12 hours on the following Friday night and Sunday night, whereas I typically only sleep approximately 6 to 7 hours per night. I noted significant stuffy nose and fatigue for the 3 to 4 days following the vaccine continuing until today.
48 2021-01-17 muscle twitching Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she s... Read more
Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she started experiencing tachycardia. EMS was called to her home. She was evaluated and transported by car to the ER. EKG and labs were done (normal). It could not be determine if the vaccine was the cause. Dec 29th she went back to the ER for tachycardia and shortness of breath. Once again labs and EKG performed (normal). She had an appointment with a cardiologist that evening; a Holter monitor and an echo were ordered. She continued to have bouts of shortness of breath, tachycardia, muscle aches, and intermittent twitching. Went back to the ER Dec 31st
48 2021-01-17 tingling, face paralysis tingling sensation in right eye and mid cheek area,Unable to wink, or scrunch right eye; muscles on ... Read more
tingling sensation in right eye and mid cheek area,Unable to wink, or scrunch right eye; muscles on the right side of my face were noticeably weaker; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), via an unspecified route of administration, on 23Dec2020 at 04:00 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at Public Health Clinic/Veterans Administration facility, age at vaccination was 48-years-old. No other vaccine was received in four weeks. Medical history included gastrooesophageal reflux disease (GERD). Known allergies included levofloxacin (LEVOFLOXACIN), pethidine hydrochloride (DEMEROL), phenobarbital, cefalexin monohydrate (KEFLEX), charithromycin (BIAXIN). Concomitant medications included dexlansoprazole (DEXILANT), estradiol, phentermine, ergocalciferol (VIT D), calcium. The patient was not tested for covid prior or post vaccination. On 23Dec2020 at 04:45 PM, after leaving the clinic, the patient felt tingling sensation in right eye and mid cheek area. Within 1.5 hours, muscles on the right side of her face were noticeably weaker. Unable to wink, or scrunch right eye. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with prednisone. Outcome was recovering.; Sender's Comments: Based on a close temporal relationship causality between events "tingling sensation in right eye and mid cheek area" and "muscles on the right side of her face were noticeably weaker" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-01-17 tingling, feeling hot I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a la... Read more
I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a large room that was busy with my mask, jacket and glasses on, I calmed down but did not feel well. I walked to my car, my fingers were a little tingly, then when I took my mask off the left side of my face was swelling, tingly, red (I have rosacea- but this was different) I did not panic, but I knew something was wrong. I decided to drive to the hospital instead of driving home, the valet said my face was swelling. I went to the ER - was given Pepic and Benadryl via an IV - I was there for observation - as I was waiting for my medication, I began to feel itchy at the base of my neck and on my chest
48 2021-01-17 tingling At approximately hour 40 post vaccine my Axillary lymph node became very enlarged, painful and hard.... Read more
At approximately hour 40 post vaccine my Axillary lymph node became very enlarged, painful and hard. It was causing a tingling in my arm, like a pinched nerve and was painful to keep my arm in a relaxed position. The node was visible if I lifted my arm above my head. With a dose of ibuprofen, the swelling reduced but it was still palpable and painful for the next 18 hours. By the 72 hour vaccine mark, all symptoms were gone.
48 2021-01-17 tenderness, pain in extremity 2 weeks later and I am still having pain and tenderness in arm, arm feels heavy and sometimes I have... Read more
2 weeks later and I am still having pain and tenderness in arm, arm feels heavy and sometimes I have weakness. There is no rash or swelling
48 2021-01-18 inability to speak, tremor 1. Nausea 2. Tremors 3. Lack of ability to speak 4. Lack of ability to sit EpiPen administered and ... Read more
1. Nausea 2. Tremors 3. Lack of ability to speak 4. Lack of ability to sit EpiPen administered and EMS called
48 2021-01-18 pain in extremity Sore arm, headache. Runny nose Took Tylenol
48 2021-01-18 tremor, discomfort, weakness Approximately 1 and a half hour after received 2nd dose of vaccine, patient felt weakness, heaviness... Read more
Approximately 1 and a half hour after received 2nd dose of vaccine, patient felt weakness, heaviness and tremors in the legs, that needed attention at the ER. Patient received hydration with NaCL 0.45% 1 L. Started to fell well and was D/H. 2 days later started with another reaction that was reported at VAERS e-report 248300. (This was reaction #1)
48 2021-01-18 tremor, discomfort Patient had 2 adverse reactions with the same administration of vaccine (2nd dose). At the day of t... Read more
Patient had 2 adverse reactions with the same administration of vaccine (2nd dose). At the day of the vaccine, patient started with leg weakness and a sensation of "heaviness" and tremors. Received hydration at ER Room. But 2 days later, developed severe lymphadenopathy at axilla of the same arm (right) where received vaccine.
48 2021-01-19 weakness Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade feve... Read more
Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade fever and chills all over my body especially the head, extreme weakness. It lasted for 2 days.
48 2021-01-19 burning sensation, numbness mild headache from Jan 11-16th, starting on the 16th __complete left facial numbness and burning fro... Read more
mild headache from Jan 11-16th, starting on the 16th __complete left facial numbness and burning from left shoulder to the top of the head and moderate to severe headache
48 2021-01-19 burning sensation HEADACHE, TIRENESS, ITCHING, BURNING SENSATION OF THE SKIN, MILD FINE, GENERALIZED SYMETRICAL RASH, ... Read more
HEADACHE, TIRENESS, ITCHING, BURNING SENSATION OF THE SKIN, MILD FINE, GENERALIZED SYMETRICAL RASH, WORSE IN ARMS, CHEST AND ABDOMEN. NOW NO HEADACHE/PAIN IN INJECTION SITE, BUT CONTINUES WITH RASH, BURNING SENSATION AND ITCHING DESPITE SOLUMEDROL INTRAVENOUS ON 10/13/2020 AT DOCTOR'S OFFICE, HYDROXYZINE 25 MG THREE TIMES A DAY, BETAMETHOSNE CREAM SINCE 01/13/2020 AND PREDNISONE 50 MG BY MOUTH DAILY SINCE 1/18/2020
48 2021-01-19 feeling hot, throat numbness, numbness 10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. S... Read more
10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. She reported throat tightness. , nausea and dizziness. 2 MDs were in the Observation area. They assessed her, gave her 25 mg Benadryl IM and 3 puffs of Albuterol inhaler. Heart rate 110, Resp Rate 12, O2 sat 98% on room air. Pt continued to fell warm and "weird." MDs wanted her to go to hospital but pt refused. Her employer offered to drive her to the ER but she refused. The MDs remained with her, monitoring for another hour. Pt was feeling better and chose to have her husband pick her up.
48 2021-01-19 feeling hot Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, onl... Read more
Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, only prior sensitivity to Avocado. During clients 15 minute wait she stepped outside complaining of being hot. A nurse provided water for client, as well as juice. She stated she felt better. Nurse accompanied her back in side, and went over other signs and symptoms of anaphylaxis. Client stated she was not experiencing any of those symptoms and that she felt better. When her wait was complete, she walked to the coat room with other employees, and her throat and ears began to itch, and she was coughing to help itch her throat. At this time the vaccine director was alerted and anaphylactic protocol was initiated. EMS was called- the time was 4:37 pm, pulse was 80, blood pressure was 178/108. 4:39- client refused epi, so 1mL/50Mg, IM Benadryl was given in the right deltoid. Simultaneously, a tourniquet was placed above the vaccine site on the left deltoid. Distal pulses monitored in left arm every 5 minutes. 4:41 itching and coughing increased, client agreed to Epi. 0.3 mg Epi pen given in right thigh. EMS arrive and transported client to hospital for observation.
48 2021-01-19 migraine Migraine, progressively worsening approx 2 hr after 2nd vaccine. Then chills, body aches, nausea, ex... Read more
Migraine, progressively worsening approx 2 hr after 2nd vaccine. Then chills, body aches, nausea, extreme fatigue. Lasted for 30 hrs. Fatigue remained another 24hrs. Felt like bad cold or mild flu. I treated with over the counter medication after my physician said that was appropriate. Still worth getting the vaccine! I?m thankful I could receive it.
48 2021-01-19 tremor Approximately 7 hours after receiving the second dose of COVID-19 vaccine, reporter noted lightheade... Read more
Approximately 7 hours after receiving the second dose of COVID-19 vaccine, reporter noted lightheadedness, dizziness, mild intermittent aches and neck pain. Approximately 12-13 hours post dose, reporter developed serious systemic aches and pains, uncontrollable shaking, chills, nausea, vomiting, and developed a fever of up to 103.1. These more severe symptoms lasted approximately 3 hours and were treated with acetaminophen and ibuprofen only.
48 2021-01-20 feeling cold Fever 37.3 C and 37.6 C Muscle pain Chills Headache Pain in the left arm at the site of injection Sy... Read more
Fever 37.3 C and 37.6 C Muscle pain Chills Headache Pain in the left arm at the site of injection Symptoms started 12 hours after the injection. They last about 12-14 hours. I took aspirin, ibuprofen and Tylenol.
48 2021-01-20 flushing Flushing accompanied by redness started about 25 minutes after shot while driving home. Chest heavin... Read more
Flushing accompanied by redness started about 25 minutes after shot while driving home. Chest heaviness without SOB or difficulty swallowing. Itching began starting with face then neck, chest and torso. Itching then spread to the whole body with a patina rash appearing on the face, neck and chest a few hours later. Immediately took dose of liquid Benedryl upon arriving home. Followed up by dose of Zyrtec. Continued monitoring sxs throughout the evening. Took additional 2 doses of Benedryl with a dose of Singular. Sxs severity lessoned though the night and into the next day. Mild itching and a few patches of the rash remained the next day 1/20/21. Continued taking antihistamine and allergy medication. All sxs have resolved as of 1/21/21
48 2021-01-20 numbness, tingling left arm numbness and tingling
48 2021-01-20 pain in extremity Dizziness; brain fog; achy; chills; sore arm; This is a spontaneous report from a contactable other ... Read more
Dizziness; brain fog; achy; chills; sore arm; This is a spontaneous report from a contactable other HCP(patient). A 48-year-old female patient received first dose BNT162B2, via an unspecified route of administration at Arm Right on 30Dec2020 10:00 at the 48 years old at single dose for COVID-19 immunization. The medical history included Rheumatoid arthritis and Depression. The concomitant medications were hydroxychloroquine phosphate ( PLAQUENIL ), leflunomide(ARAVA), desvenlafaxine succinate(PRISTIQ). The patient previously took Methotrexate and experienced allergies. On 31Dec2020 11:00, the patient experienced Dizziness, brain fog, achy, chills, sore arm. Mild for maybe 6 hours and a couple hours were moderate. Woke the next day on 01Jan2021 feeling fabulous. There was no treatment received for all the adverse events. There was covid tested post vaccination. There was no other vaccine in four weeks. The patient underwent lab tests and procedures, which included Nasal Swab on 30Oct2020 Negative. The outcome of the events was recovered on 01Jan2021. Information about lot/batch number has been requested.
48 2021-01-21 bell's palsy, numbness, tingling Within the hour of having the injection , I was having a numbness sensation in my right eye and chee... Read more
Within the hour of having the injection , I was having a numbness sensation in my right eye and cheek area. Seen in the walk in clinic dx with Bells Palsy, seen in the ER, confirmed Bells palsy. Started prednisone. Symptoms within 3-4 days at 90%. Continued prednisone. Nausea, headache, aches on 1/4-1/6 felt better until 1/20- just had extreme back aches , 1/20 eye felt numb again, muscle movement remained the same. headache, body aches, pins and needles in 3 middle toes on the right side.
48 2021-01-21 numbness Patient experienced numbness in left side of face
48 2021-01-22 muscle twitching, muscle spasms Around the 18 minute mark began having an odd facial sensation. There was intermittent tightening ... Read more
Around the 18 minute mark began having an odd facial sensation. There was intermittent tightening feeling at eyebrows and across forehead that would then flutter/spasm, subside, then repeat. The episodes would last 1-3 seconds intermittently for 25-30 mins. No treatment was sought, it did not affect any daily functions.
48 2021-01-22 tingling Day of vaccination: headache and right side face tingling. Followed by 2 days of fatigue. Day 9 pos... Read more
Day of vaccination: headache and right side face tingling. Followed by 2 days of fatigue. Day 9 post vaccination: raised redness, hard knotted area, pain and itching at injection site. And 2-3? diameter around injection site.
48 2021-01-22 tingling tingling/itching on back and neck, shoulders arms; pt denies SOB, wheezing, rash, hives, nausea, sta... Read more
tingling/itching on back and neck, shoulders arms; pt denies SOB, wheezing, rash, hives, nausea, states "it may be nerves"; recommended to take benadryl when getting home; info given
48 2021-01-22 tremor Fever100.5, body aches, chills, shaking, headache, rapid heart rate
48 2021-01-23 pain in extremity, tingling Patient returned to clinic 3 weeks after her first dose of the Pfizer COVID19 vaccine to complete th... Read more
Patient returned to clinic 3 weeks after her first dose of the Pfizer COVID19 vaccine to complete the second dose in the series. When nurse asked regarding post vaccination response, patient reported expected muscle soreness at site (right deltoid) for 2 days, however expressed new localized symptoms at the site that began the evening of the second day. Symptoms included pain radiating down the length of right arm, tingling fingers, and weakness in right arm. Patient was able to manage pain with OTC analgesics, however expressed concern with length of the symptom's duration. After 21 days post vaccine administration, she expressed she continues to have pain in right arm when held in certain positions. Nurse took down information, notified supervisor and encouraged patient to follow up with her doctor. Nurse explained to the patient that a report would be completed and that further communication with her could be possible after reporting. Patient was in agreement with plan. Nurse completed assessment and education for second dose finding no contraindications. Patient consented to receiving her second Pfizer COVID19 vaccine in her left arm. Administration was completed in left deltoid with no immediate adverse effects.
48 2021-01-23 speech disorder, difficulty speaking chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking.... Read more
chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
48 2021-01-24 migraine, pain in extremity Sore Arm within few hours after injection which went away after 2 days. The next day woke up with m... Read more
Sore Arm within few hours after injection which went away after 2 days. The next day woke up with migrane like headache, took 2 Advil and within an hour felt better. Also felt very tired for several days.
48 2021-01-24 pain in extremity Left arm pain leading to chest wall pain with pmhx of angina. 6/10 pain radiating to left neck, SOB.
48 2021-01-24 tingling, flushing Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness a... Read more
Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness approx 1.25-1.5 hours after injection. around 12:10 pm or so. Removed excess clothing, put head between legs and turned on fan. Symptoms improved within 15 minutes. Headache later Saturday evening. Face hot and flushed and bad headache around 6pm Sunday evening. Face hot and flushed still Monday 1/25 in am but is getting a little better (I think) at the time of report.
48 2021-01-25 weakness, pain in extremity extreme fatigue. I slept for two days following both vaccines, decreased energy. Sore arm which afte... Read more
extreme fatigue. I slept for two days following both vaccines, decreased energy. Sore arm which after the second dose remains a dull ache now at two weeks and 3 days after the second dose. Still have severe fatigue. I want to sleep all day.
48 2021-01-25 weakness Sore Injection Site, Neck Pain, Nausea and Weakness
48 2021-01-25 weakness My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal B... Read more
My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal BP runs usually 115/78 to 120/78)paramedic check me at 15min twice at that time. my tong was felt numb; i went home and took some Benadryl and a Tylenol for my headache , rise my legs up for about 1hr drink 3 water bottles and less than 1/2hr, my BP drop to 113/75 i went to bed felt very tired , next day, very tired my BP low 106/70 muscles achy, got diarea and nausea per one day, since then my BP keeps low, I have no energy, I call my dr. yesterday, he advised that I should be good by today; my BP keeps been in the lows, my back hurts, i have no energy; I need to call back my dr. by Thursday or Friday to see how am i doing;. he referral to ENT to check on my smell and test as follow up because i have covid back in june2020 and I'm having a hard time with it.
48 2021-01-25 burning sensation Within a hour and a half my throat was on fire, and I called a virtual care through my insurance and... Read more
Within a hour and a half my throat was on fire, and I called a virtual care through my insurance and saw a provider via telehealth. She gave me Augmentin and prednisone. My sinuses were irritated. I had flu like symptoms but no fever. I was treated for strep throat. I have had mild throat burning since and have not fully recovered. I have had a severe headache ever since and have had to rotate Tylenol and ibuprofen everyday. I went into the ER 01/22/2021 with severe chest pain and they said I had GERD.
48 2021-01-25 burning sensation Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan... Read more
Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan was provided, issue resolved in about two hours.
48 2021-01-25 pain in extremity, muscle spasms I woke up early that morning and both of my legs were aching and cramping. It was very painful. Last... Read more
I woke up early that morning and both of my legs were aching and cramping. It was very painful. Lasted about a hour and stopped. I have burning in my throat still from the first injection.
48 2021-01-25 pain in extremity Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report... Read more
Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm single dose for COVID-19 immunization on 10Jan2021, 09:30 AM, at 48-year-old. Medical history and concomitant medication were not reported. No known allergies. The patient did not have COVID prior vaccination. The patient did not have other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm for COVID-19 immunization on 20Dec2020, 05:30 PM, at 48-year-old. On 11Jan2021, 05:00 PM, the patient had left arm pain in armpit with swollen lymph nodes, led to whole left arm pain. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. Information on the lot/batch number has been requested.
48 2021-01-25 tingling Pruritus; paresthesia across body, particularly extremities; This is a spontaneous report from a con... Read more
Pruritus; paresthesia across body, particularly extremities; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 13Jan2021 10:15 at a single dose on left arm for COVID-19 immunization. Medical history included hypertension (HTN). Concomitant medication included amlodipine besilate (NORVASC) and metoprolol tartrate (LOPRESSOR). About 8 hours after immunization, patient started to have pruritus and paresthesia across body, particularly extremities on 13Jan2021 06:00 PM. Therapeutic measures were taken as a result of the events which included Hydroxyzine Hcl (ATARAX). The outcome of the events was not recovered. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. AE resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Not covid tested post vaccination. Information on the lot/batch number has been requested.
48 2021-01-25 tremor Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal ... Read more
Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal response with near syncope episode. Gave Diphenhydramine approximately 25 minutes after onset.
48 2021-01-26 bell's palsy Reporter received second COVID-19 vaccine on Wednesday 1/19 with no immediate side effects. On Frid... Read more
Reporter received second COVID-19 vaccine on Wednesday 1/19 with no immediate side effects. On Friday, 1/22, reporter began experiencing issues blinking. Saturday morning, 1/23, side effects expanded to her mouth. She called a 24/7 health hotline and was diagnosed with Bell's Palsy. She began prednisone Saturday afternoon (1/23). Symptoms persist, but do not seem to be progressing. Has been to her PCP who confirmed initial diagnosis and will schedule appt with endocrinologist to address change in blood sugars with prednisone. Received the vaccine in her right arm, which is the same side of her face affected.
48 2021-01-26 burning sensation My eyelids swelled and my face became red/itchy and burn. It's been a week and I'm still experienci... Read more
My eyelids swelled and my face became red/itchy and burn. It's been a week and I'm still experiencing it all.
48 2021-01-26 numbness Systemic: cheek numbness, resolved with 25 mg of benadryl
48 2021-01-26 pain in extremity, numbness Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest... Read more
Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest pain left side Jaw pain left side Kidney pain left side Headache Was given Nitro pill and 3 1/2 baby aspirin by paramedics at testing site. Another Nitro pill in ambulance on the way to hospital. Treated for heart attack dueto Vaccine
48 2021-01-26 pain in extremity Sore Arm, Fatigue, General feeling of sick, Hives,
48 2021-01-26 tremor, feeling cold First inject lot # ej1685 in right arm. had itchy rash with open wounds all over right breast with... Read more
First inject lot # ej1685 in right arm. had itchy rash with open wounds all over right breast with burning pain. Was told is was shingles but wasn?t treated. Was told to get the second vaccine in the opposite arm to see if the same thing happens. Received 2nd injection in left arm and ended up with full blown symptoms of COVID. Uncontrollable shakes, cold, fever, severe body aches, cough, diarrhea and the rash still remains. As of today, I have an upper respiratory infection as well as the open rash, which the PCP listed has taken control of and deemed the cause side effects of the second injection.
48 2021-01-27 weakness, tingling, cold sweat severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weaknes... Read more
severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weakness; This is a spontaneous report from a contactable Other Health Professional. A 48-year-old female patient (not pregnant) received 2nd dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via intramuscular on 12Jan2021 13:30 at single dose on left arm for covid-19 immunisation. Medical history included mild asthma. There were no concomitant medications. Historical vaccine included 1st dose of bnt162b2 (lot: EJ1685) on 23Dec2020 left arm at single dose for COVID-19 Immunization (age at vaccination was 48 years old). Approximately 11 hrs after 2nd vaccine, patient developed severe rigors, severe arthralgias and myalgias as well as skin parasthesia, severe cold sweats and profound weakness. Symptoms improved with APAP (acetaminophen) plus ibuprofen alternating q3 hrs x24 hrs. Outcome of the events was resolving. This case was reported as non-serious.
48 2021-01-27 flushing Itching, vomiting, feeling flush, chest tightness
48 2021-01-27 hypersensitivity of all senses headache, body aches, fatigue, loss of appetite, skin sensitivity
48 2021-01-27 pain in extremity Under my left arm was sore after each dose of the Pfizer-BioNTech COVID-19 Vaccine. I suspect swolle... Read more
Under my left arm was sore after each dose of the Pfizer-BioNTech COVID-19 Vaccine. I suspect swollen lymph nodes. The reaction occurred 7days after the first dose and the next day after the 2nd dose. While the armpit started to feel better before the 2nd dose I wouldn't say symptoms resolved before the 2nd shot.
48 2021-01-27 pain in extremity Arm was very sore couldn't move it started taking ibuprofen that night. On Sunday arm started turnin... Read more
Arm was very sore couldn't move it started taking ibuprofen that night. On Sunday arm started turning red a size of a softball was extremely red swollen and hot to the touch, shoulder area and under arm pit was swollen and hurt to touch are move. Was informed by employee health to start taking antihistamines (which I already take) so she told me to increase the amount by taking Benadryl as well and icing it on and off for 30 minutes at a time, The people here at my work checked it regularly and slowly it is improving each day as long as I ice and take extra antihistamines.
48 2021-01-27 tremor rash on fash and I believe on scalp that is itchy, tried taking benedryl but it did not make a diff... Read more
rash on fash and I believe on scalp that is itchy, tried taking benedryl but it did not make a difference. shoulders and back also itchy but rash does not appear to have spread there. hands are trembling.
48 2021-01-28 feeling hot, tingling, pain in extremity 24 hours after vaccine, both arms began to hurt very bad, felt hot and tingly. Shooting pains in bot... Read more
24 hours after vaccine, both arms began to hurt very bad, felt hot and tingly. Shooting pains in both wrists and left knee. Became very dizzy. The pain lasted for about 8 hours then moved into both legs with shooting pains in both ankles. The leg and ankle pain lasted for about 8 hours. Now I am just very sore in all extremities and joints. Moving very slowly compared to my usual. Feel very run down. Also had very itchy arms about 8 hours in only for a few minutes, no rash.
48 2021-01-28 numbness, tingling Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tinglin... Read more
Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tingling of left side of face; numbing and tingling of left side of face and left side of upper/lower lips; numbing and tingling of left side of face and left side of upper/lower lips; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included none. Patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced dry mouth, numbing and tingling of left side of face and left side of upper/lower lips, numb on left side of neck on 06Jan2021. Shot was in left arm. Concerned about getting second vaccine. No treatment received in response to the events. The outcome of the events was recovering. The patient was not pregnant. Facility type vaccine was Public Health Clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
48 2021-01-28 tenderness Total body joint pain, low grade fever, headache x 16hrs Injection site pain, axillary pain/tenderne... Read more
Total body joint pain, low grade fever, headache x 16hrs Injection site pain, axillary pain/tenderness x 1 week
48 2021-01-29 flushing with dose 1given on 1/7/21 - within 5 mins -flushing, headache, chills, back pain., high blood press... Read more
with dose 1given on 1/7/21 - within 5 mins -flushing, headache, chills, back pain., high blood pressure in 150's, fatigue. Headache and backache lasted for 4 days. Fatigue for a week. I was monitored for 2 hours after injection. With dose 2 on 1/29/21- immediate - nausea, headache, lightheadedness, chest discomfort, very sleepy like I just wanna go to sleep right away. I was monitored for 2 hours until Chest discomfort subsided. nausea took more than 3.5 hours. headache is still on today the next day. Midnight -I had severe severe joint pains like my bones were ripping apart. very sleepy. i slept 12 hours straight. still have headache.
48 2021-01-29 pain in extremity Malaise and severe joint pain, nausea, frequency in bowels, stomach pain, dizziness, headache that s... Read more
Malaise and severe joint pain, nausea, frequency in bowels, stomach pain, dizziness, headache that started about 12 hours post injection in the night. Arm pain radiating into axilla and down arm from injection site. A bit disoriented upon waking, pushed fluids and OTC meds with some relief of pain but GI symptoms persisted.
48 2021-01-29 tingling, cold sweat, numbness Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and... Read more
Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and tingling in vaccine arm Went to ER for monitoring Ten minutes after started the worst headache of my life and I get migraines Have had pulse racing and slight chest pains all afternoon Went home after 4 hours observing Got a steroid through IV Fever has started after 12 hours
48 2021-01-30 pain in extremity Arm sore, headache, fever, myalgia stared about 12 hours after 2nd dose of vaccine. Reactions laste... Read more
Arm sore, headache, fever, myalgia stared about 12 hours after 2nd dose of vaccine. Reactions lasted one day.
48 2021-01-30 pain in extremity Around 5pm (12/28): chills, arm soreness on site of injection Trouble sleeping as sleep cycles inter... Read more
Around 5pm (12/28): chills, arm soreness on site of injection Trouble sleeping as sleep cycles interrupted by nightmares, also fever (101), chills and muscle/ joint aches 12/29: nausea/ vomitting with worsening joint/muscle aches. Sent home without finishing workday. Fever continue all day and all night with syncopal episode on friday night. My husband gave me ice bath to break the fever which was 102 ( according to him). *unable to got to the bathroom unassisted from Friday afternoon and all day Saturday* 12/30: fever, muscles, joiny aches and headaches persisted but lesser in severity 12/31: first day fever free ( last and only dose of tylenol at 6am). Mild headache at time of filling up this report(8:51pm) Able to go the bathroom unassisted all day.
48 2021-02-01 numbness Patient honked horn 10 minutes after receiving vaccine. C/o numbness in left side of face and in le... Read more
Patient honked horn 10 minutes after receiving vaccine. C/o numbness in left side of face and in left hand. No SOB. BP 110/64, HR WNL. 911 called at 3:54PM and 25mg of liquid Benadaryl given orally. Red rash on patient's chest appeared at 3:46 PM, continued numbness. EMS arrived at 3:59PM. Report given and patient transferred to Hospital with normal vital signs and no SOB.
48 2021-02-01 pain in extremity nauseous; mild to moderate arm pain; injection site pain; Pain was from wrist to shoulder; moderate ... Read more
nauseous; mild to moderate arm pain; injection site pain; Pain was from wrist to shoulder; moderate vasomotor symptoms; body aches; This is a spontaneous report from contactable nurse (patient herself). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 10:00 in right deltoid at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included estrogens conjugated, medroxyprogesterone acetate (PREMPRO). On 19Jan2021, patient experienced mild to moderate arm pain in arm that had shot, more than just injection site pain. Pain was from wrist to shoulder. 2-3 hours later moderate vasomotor symptoms followed with body aches. She took celecoxib (CELEBREX)and paracetamol (TYLENOL), body aches got better. 7 hours post injection, she felt nauseous and took ondansetron (ZOFRAN). Outcome of events were unknown. Information on the lot/batch number has been requested.
48 2021-02-01 pain in extremity I began noticing 2 days after receiving the second vaccine joint stiffness and aches. At the end of ... Read more
I began noticing 2 days after receiving the second vaccine joint stiffness and aches. At the end of my 9 hour shift I was very stiff in all of my lower joints from the hips down as well as uncomfortable from the achiness. I walked slowly and stiffly as I was leaving work. I felt extremely tired that night and decided to work a shorter shift the next day - 8 hours rather than 9 hours. I took ibuprofen prior to my second shift. I was still achy and stiff but it was a little better witht he ibuprofen. The next day at home on the weekend I was again achy and stiff and took ibuprofen. I woke up on 1/25 with swollen hands that were painful and stiff. I have since had daily swelling of both hands and achiness in wrists non
48 2021-02-01 pain in extremity L upper arm, L shoulder and L side of neck pain. Treated with massage, stretching and Ibuprofen. Sym... Read more
L upper arm, L shoulder and L side of neck pain. Treated with massage, stretching and Ibuprofen. Symptoms are getting better but on-going.
48 2021-02-01 tingling, feeling hot This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT1... Read more
This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at the left arm on 13Jan2021 at a single dose to protect against COVID. Medical history included under active thyroid in Jul2019. There were no concomitant medications. The patient woke during the night feeling like she was on fire feeling prickly throughout her body/her whole body got really hot and she had to cool with a rag on 19Jan2021 03:00. Outcome of the events was unknown.
48 2021-02-01 tingling Immediate dry mouth and agitation - drank water to try to combat dry mounth 1 minute marker - tightn... Read more
Immediate dry mouth and agitation - drank water to try to combat dry mounth 1 minute marker - tightness in throat, difficulty swallowing and slight confusion begins - drank more water and began to suck on lollipop 5 minute marker - confusion, tightness in throat worsens and lump in throat begins - I alerted medical staff who attended to me and gave me a cold compress. 10 minute marker - Drank water, self administered 2 children's dissolvable Benadryl 20mg - remained at hospital for one hour under observation. 50 minute marker - throat still tight, lump subsided, difficulty swallowing persists, confusion lessens, extreme dry mouth persists, tingling in extremities comes and goes - self administered 2nd Benadryl 25mg 60 minutes - left clinic 90 minutes - called primary care physician and left a message 3 hours - primary care responded to take prednisone 20 - 40 mg every 6 hours for 2 days. 3 hours 20 minutes - all symptoms described above subsided. Prednisone was taken for 36 hours as tightness in throat, issue swallowing and lump came back when I tried to stop the Prednisone at 48 hours.
48 2021-02-02 feeling hot Patient felt light headed and hot. She then c/o scratchiness in her throat and a little shortness of... Read more
Patient felt light headed and hot. She then c/o scratchiness in her throat and a little shortness of breath. Patient was administered Benadryl 50mg IVP and was monitored at the site of vaccination. She refused transport. She stated that she felt much better.
48 2021-02-02 hot flush Client stated she felt a warm sensation going down her left arm. "almost like a hot flash, but just... Read more
Client stated she felt a warm sensation going down her left arm. "almost like a hot flash, but just in my arm". Client continued to be coherent. 4:20 pm B/P 122/90/98 pulse=78 Pulse Oximeter 98% 4:25 pm B/P 122/88 pulse=79 Pulse Oximeter 98% 4:30 pm B/P 128/88 pulse=80 Pulse Oximeter 99% Client stated she felt fine. Released from clinic site. Encouraged to contact medical provider if symptoms returned.
48 2021-02-03 feeling hot Patient states she was waiting in post vaccination area when she began to become very anxious. Her h... Read more
Patient states she was waiting in post vaccination area when she began to become very anxious. Her heart was racing, felt hot, rash on chest, and felt throat feel thick. EMS was on site and took vital signs. Transported patient to Emergency Department via ambulance. Benedryl and Prednisone were administered IV. Patient was monitored for 4 hours at Emergency Department. Followed up with patient today. She is continuing to take Benedryl. Feels much better.
48 2021-02-03 feeling jittery, cold sweat, cold extremities she woke up her hands and feet were very cold; her hands and feet started feeling cold clammy and sw... Read more
she woke up her hands and feet were very cold; her hands and feet started feeling cold clammy and sweaty; hands and her feet have been sweating; feeling jittery; has not been able to sleep; feeling very nervous and anxious; feeling very nervous and anxious; she can feel cold air through her skin easier now/ under hot water her fingers and feet feel more sensitive to hot water; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on 11Jan2021 17:30 at a single dose on left arm for COVID-19 immunization (COVID-19 vaccination). The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 23Dec2020 at a single dose for COVID-19 immunization. The patient said that she got the second shot on Monday 11Jan2021 about 17:30 in the evening. On Tuesday 12Jan2021, when she woke up, her hands and feet were very cold. Her hands and her feet have been sweating. Her hands and feet started feeling cold clammy and sweaty the next day on Tuesday 12Jan2021 while she was working from home. She is also feeling jittery and she has not been able to sleep and she is feeling very nervous and anxious (onset date for feeling very nervous and anxious also reported as 13Jan2021, pending clarification). She said that she can feel cold air through her skin easier now it feels like, and also said that even under hot water her fingers and feet feel more sensitive to hot water than they did before. She has never had these symptoms (feel nervous and anxious) before. It made her nervous thinking that maybe the shot caused her hands and feet to feel cold and sweaty. The outcome of the events was not recovered.
48 2021-02-03 flushing, discomfort, tingling Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/di... Read more
Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/dizzy; lightheaded/dizzy like she was going to pass out; Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on; Had a heavy feeling in her chest; Tingling sensation on her lips; Tingling sensation on the right side of her face, and cheek; Severe burning in her right ear; Sore throat on the right side; When she was speaking it sounded like she had a thick tongue; Tongue feels swollen; Pain at the base of her skull on the right side; Pain on the right side of her forehead; Pinpoint pain that went down the right side of her spine; Metallic taste in her mouth; felt off; Pain at the injection site; It was so bad that it would wake her up if she rolled over; This is a spontaneous report from a contactable Nurse reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3248), via an unspecified route of administration on 15Jan2021 at single dose (Once by injection in the right arm) for COVID-19 immunisation. The patient medical history was not reported. Historical vaccine included Hepatitis B vaccine. There were no concomitant medications. On 15Jan2021, after 15 minutes of monitoring she was fine. 5 minutes later or so (after 20 minutes), she had a flushed feeling and was lightheaded/dizzy like she was going to pass out. She returned to her office. She had someone check her blood pressure which was fine. It was 110/60. Normally it runs low in the 90s. Again, she thought she looked flushed. It was reported she had a heavy feeling in her throat and chest and on her face. She had removed her mask but it still felt like she still had it on. She had brought Benadryl with her, as she has had a reaction to the Hepatitis B vaccine before. She took the Benadryl since she felt off. She thinks this first part of what she experienced triggered everything else. By the time she got home, she had a tingling sensation on the right side of her face, on her lips and cheek. She had severe burning in her right ear. She also had a sore throat on the right side. Heaviness in her throat and chest- resolved late Saturday to early Sunday (Jan2021). Her husband noticed on Friday evening (15Jan2021) when she was speaking it sounded like she had a thick tongue. Saturday morning it was more normal. Her tongue does feels swollen. She also developed pain at the base of her skull on the right side. This started about 2 hours after the vaccine. She had pain on the right side of her forehead. She had pinpoint pain that went down the right side of her spine. She also developed a metallic taste in her mouth. She had pain at the injection site. It was so bad that it would wake her up if she rolled over. On 17Jan2021, she slept all day Sunday and also had extreme fatigue. On 18Jan2021, her right eyelid feels heavy on 18Jan2021. She does not think any of these are serious, but stated they are concerning. Vaccination card does not have the NDC or expiration date on it. Patient asked is getting the second dose of the injection recommend. She is leaning towards no but wanted to see what was recommended. She has reached out to her primary care about this. Outcome of the events flushed feeling, lightheaded/dizzy, lightheaded dizzy, like she was going to pass out was recovered on 15Jan2021. Outcome of the events when she was speaking it sounded like she had a thick tongue was recovered on 16Jan2021; Outcome of the events pain at the base of her skull on the right side, pain on the right side of her forehead, pinpoint pain that went down the right side of her spine, extreme fatigue, pain at the injection site was recovered on 17Jan2021; Outcome of the events Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on, and Had a heavy feeling in her chest was recovered on Jan2021. Outcome of the events severe burning in her right ear, sore throat on the ride side, tingling sensation on her lips, tingling sensation on the right side of her face and cheek was recovering. Outcome of the events tongue feels swollen, metallic taste in her mouth, right eyelid feels heavy was not recovered. Outcome of the events it was so bad that it would wake her up if she rolled over, she slept all day Sunday, and felt off was unknown. The reporter considered the events as non-serious. Causality assessment for events for felt off, she slept all day Sunday, It was so bad that it would wake her up if she rolled over was not reported. Causality assessment for all other events was reported as related.
48 2021-02-03 flushing C/O headache, became flushed in face BP, Pulse, respirations monitored for 1 hours and 45 minutes, c... Read more
C/O headache, became flushed in face BP, Pulse, respirations monitored for 1 hours and 45 minutes, cold compress to face and ice pack to left arm site
48 2021-02-03 numbness, burning sensation Headache; complete left sided facial burning; complete numbness starting from the neck to the top of... Read more
Headache; complete left sided facial burning; complete numbness starting from the neck to the top of the head; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in left arm on 11Jan2021 12:00 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included depression and metabolic syndrome from an unknown date and unknown if ongoing. Concomitant medication included bupropion hydrochloride (WELLBUTRIN SR), metformin hydrochloride (METFORMIN) and vitamin B complex (VITAMIN B). The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Jan2021 05: 00 PM, the patient experienced moderate to severe headache, complete left sided facial burning and complete numbness starting from the neck to the top of the head. No treatment was given to the patient for the events. The outcome of the events was recovering.
48 2021-02-04 slurring, facial paralysis, numbness it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left ton... Read more
it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left tongue felt numb and fat as though I got injected at the dentist; Then medicine taste in my mouth and some slurring; Then medicine taste in my mouth and some slurring; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received first dose of BNT162B2 (Lot number and expiry date not available), via an unspecified route of administration on 21Jan2021 10:45 at single dose in the left arm for COVID-19 immunization. Medical history included Hypo thyroid (medication not needed at this time). The patient had no known allergies. Concomitant medication included cefixime (FLEXERIL) and ibuprofen (IBU). On 21Jan2021 11:00, after 15 minutes of getting the vaccine, the patient felt nauseated. Then it continued to get worse from there left side of face numb, mental fog, left tongue felt numb and fat as though she got injected at the dentist. Then medicine taste in her mouth and some slurring. Stated that her boss which is doctor side it looks and sounds like she has Bell palsy. She was prescribed Methylprednisolone and she feel somewhat better. Still waiting to feel completely myself. It's been now about 8 hours since her vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included methylprednisolone. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 to the onset of reported events Bell palsy and mental fog occurred 15 minutes after getting the vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-02-04 hot flush Increase in hot flashes especially at night. I am perimenopausal and have had occasional hot flashes... Read more
Increase in hot flashes especially at night. I am perimenopausal and have had occasional hot flashes, but now I am having hot flashes every night and sometime during the day. Unsure if related to vaccine, but thought being it is a new vaccine I would report it.
48 2021-02-04 migraine bad headache that felt like migraine; bad headache that felt like migraine; thought it might be a si... Read more
bad headache that felt like migraine; bad headache that felt like migraine; thought it might be a sinus headache; pain on the right side of the back of her neck that radiated behind her right eye; pain on the right side of the back of her neck that radiated behind her right eye; dizziness; sweating; swollen lymph nodes in her throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 15Jan2021 at 07:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient experienced dizziness, sweating, and swollen lymph nodes in her throat. On 18Jan2021, the patient started to get a really bad headache that felt like migraine and thought it might be a sinus headache. On the same day, the patient also had pain on the right side of the back of her neck that radiated behind her right eye. The patient would like to know if she could take anything for her headache. The outcome of the event bad headache that felt like migraine was not recovered while the other events was unknown. Information about lot/batch number has been requested.
48 2021-02-04 pain in extremity, migraine Woke up the next morning with an extremely bad headache/migraine. Light sensitive to my eyes. I h... Read more
Woke up the next morning with an extremely bad headache/migraine. Light sensitive to my eyes. I had to take ibuprofen and acetaminophen around the clock, and I went back to bed and slept until 1pm that day. Headache remained dull the rest of the day, but I began feeling better. My left arm was also very sore and second day past vaccine now have armpit soreness/pain. Took ibuprofen again today for that.
48 2021-02-05 feeling hot I had a slightly elevated temp after the shot on 1-23. At 6:45 am on the 24th it was 99.9 . All of a... Read more
I had a slightly elevated temp after the shot on 1-23. At 6:45 am on the 24th it was 99.9 . All of a sudden I felt a heat throughout my body and felt on fire while also feeling an urge of diarrhea and nausea. I tried to go to the bathroom, but kept passing out. I could not see, but was conscious. It took me 15 minutes to crawl to the bathroom. I did not vomit and passed watery stool x 2. The episode passed after about 40 minutes. I continued to have a slight elevated temp all day after that episode, but only 99.6 and below. There were no more issues after that brief, horrible reaction. I am 101 lbs.
48 2021-02-05 tremor Shot given 2-4-21 at 1236, woke up at 2-5-21 at 0130 with severe uncontrollable shaking that last ... Read more
Shot given 2-4-21 at 1236, woke up at 2-5-21 at 0130 with severe uncontrollable shaking that last approximately 2.5 hours. Joint pain was unbearable, felt like muscles were being torn apart, tried getting out of bed and hit the floor because of lack of muscle control.
48 2021-02-07 feeling cold, hot flush Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/c... Read more
Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/cold flashes; Nausea; Vomiting; Symptoms of perimenopause; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=EL9262), via an unspecified route of administration at Left arm on 19Jan2021 15:00 at single dose for covid-19 immunization. The patient medical history included known allergies: penicillin. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0142), on 01Jan2021 12:00 PM at Left arm at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site rash, swollen lymph nodes, headache, teeth hurt on left side, hot/cold flashes, nausea/vomiting, symptoms of perimenopause on 20Jan2021 at time of 12:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
48 2021-02-07 pain in extremity Pain in arm headache nausea fever body aches joint aches sensitive to light
48 2021-02-08 pain in extremity Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in t... Read more
Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in the shoulder joint that she had the shot in; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; stiffness in her neck and joints, and in both of her hands, fingers, and elbows; her neck and joints, and in both of her hands, fingers, and elbows; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; She also had pain in both biceps; Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope; This is a spontaneous report from a contactable Nurse. A 48-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021 at single dose via an unspecified route of administration in right deltoid for COVID-19 immunization. Relevant medical history included Multiple sclerosis/Diagnosed in 1991 or 1992. She also had 2 previous reactions to a pneumonia vaccine two years in a row. About 30-45 minutes after she had fainting episodes. On 07Jan2021 within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope. On the same day she complained pretty bad swelling in the shoulder joint that she had the shot in, along with stiffness in her neck and joints, and in both of her hands, fingers, and elbows. She also had pain in both biceps. On 08Jan2021 the patient experienced severe fatigue and 10Jan2021 Bilateral arm weakness/dysesthesia. They were floppy noodles and she could hardly use them. She could not hold her purse in her hands. She has not had this issue before with her Multiple Sclerosis. This took about a full week and a half for that to go away. It was like weakness/dysesthesia. She talked to her doctor and he said he felt like the shot had exacerbated her Multiple Sclerosis potentially. At the time of the reporting the patient was recovering from Bilateral arm weakness/dysesthesia. She recovered from fatigue on 09Jan2021, from 'Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope' on 10Jan2021and from other reported events on 12Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of bilateral arm weakness/dysesthesia cannot be excluded. The events are confounded by underlying multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-02-09 discomfort All over body / muscle aches - unable to sleep well due to extreme discomfort. Pain started around 8... Read more
All over body / muscle aches - unable to sleep well due to extreme discomfort. Pain started around 8pm and intensified through the night. Started to abate early afternoon next day. Did take extra strength Tylenol 4 times between 8pm 2/8/21 and 2pm 2/9/21. As of today, 2/10/21, still have joint pain in right hand knuckles and mid back / right shoulder blade and at injection site.
48 2021-02-09 migraine, tremor migraines; blood glucose dropped below 80; severe shakes; nausea; This is a spontaneous report from ... Read more
migraines; blood glucose dropped below 80; severe shakes; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 14:30 at single dose at left arm for covid-19 immunization. Medical history included fibromyalgia, chronic migraines, degeneraive disc disease, spinal spinosis, celiac, arthritis, and type 2 diabetic, known allergies. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks included prescribed medications. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Patient was a type 2 diabetic and the next day after the injection, on 05Jan2021 08:00 patient blood glucose dropped below 80 and patient usually run 128 and above. It was hard getting BG level up over 100 for over two weeks and patient had severe shakes, nausea, and migraines as an adverse effect from very low BG levels. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events was not recovered. Patient lowered insulin units as treatment.
48 2021-02-09 pain in extremity Extreme fatigue and leg aches
48 2021-02-09 tingling, discomfort swollen armpit lymph nodes and upper right arm; swollen armpit lymph nodes and upper right arm; arm ... Read more
swollen armpit lymph nodes and upper right arm; swollen armpit lymph nodes and upper right arm; arm tingling to fingers; very uncomfortable; Right armpit discomfort; This is a spontaneous report from a contactable healthcare professional (the patient). A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), intramuscular in the right arm on 20Jan2021 at 10:00 (at the age of 48-years-old) as a single dose for Covid-19 immunization. Medical history included central nervous system disorder (CIS) from an unknown date. The patient did not have any allergies to medications, food or other products. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140) on 30Dec2020 in the right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jan2021 at 18:00, the patient experienced right armpit discomfort. On 22Jan2021 the patient experienced swollen armpit lymph nodes and upper right arm leaving the right arm tingling to fingers and very uncomfortable. Therapeutic measures were not given for the events. The clinical outcome of the events axillary pain, lymphadenopathy, peripheral swelling, paresthesia and discomfort was not recovered. It was reported that since the vaccination (dose 1), the patient had been tested for COVID-19 via a PCR nasal swab on 19Jan2021 with a negative result.
48 2021-02-10 weakness Fever, severe body aches, chills, absolutely no energy, loss of appetite, hard to sit up to even dri... Read more
Fever, severe body aches, chills, absolutely no energy, loss of appetite, hard to sit up to even drink water. Similar to a horrible flu case. Worst I had felt maybe ever in my life. Took Tylenol and NyQuil. By Monday morning, about 30 hours later, was finally feeling some energy and able to go to work
48 2021-02-10 hot flush, migraine headache; Headache 'in the back of head, the right side of her face behind her eyes', started gettin... Read more
headache; Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine.; could be sinuses; Dizziness; Sweating; lymph nodes swollen; she tends to get hot flashes, she is currently going through menopause; This is a spontaneous report from a contactable consumer, the patient. A 48 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EL3248 ), intramuscular in the left arm on 15Jan2021 at 06:34 as a single dose, for COVID-19 immunization. The vaccination was administered at a Hospital Facility. Patient contact her doctor who told her, she absolutely needed the COVID-19 vaccine. Medical history included ovarian cancer 2014 (stage 3B and 3C), lymphoedema 2015, (lymphedema after aggressive chemo/ told she would always have lymphedema), and menopause from an unknown date and ongoing (tends to get hot flashes). There were no concomitant medications. On 15Jan2021 (around noon), the patient experienced Lymph nodes swollen/her lymph nodes in her throat were swelling up, dizziness, and sweating. Patient explains she tends to get hot flashes, she is currently going through menopause. However, she ran to the store and she was really sweating heavily and felt dizziness and just ended up going home. She felt it was better to be at home if she was having a reaction. By Saturday, 16Jan2021, she woke up and felt fine. The swelling of her lymph nodes in her throat went away. The dizziness and sweating went away. On 19Jan2021 (Tuesday Evening) the patient experienced Headache 'in the back of head, the right side of her face behind her eyes', started getting a migraine. Also states it could be sinuses. She didn't know if this could be related to the COVID-19 vaccine and a reaction to it or her sinuses. On Jan2021 patient experienced Hot flashes. No other vaccines were given within 4 weeks. The clinical outcome of Dizziness, Sweating was recovered on 16Jan2021, the outcome of Headache/migraine was not recovered, and the outcome of lymph nodes swollen, hot flashes and sinuses were unknown.
48 2021-02-10 pain in extremity, muscle spasms Lacy vascular rash on both calves. Calf pain and cramping.
48 2021-02-10 pain in extremity 4 hrs after injection I had severe pain in shoulder and unable to move 1/2 inch without severe pain.... Read more
4 hrs after injection I had severe pain in shoulder and unable to move 1/2 inch without severe pain. The pain compares to post op shoulder surgery or an injury and radiates thru arm into fingers. 24 hrs after injection. I spiked a fever of 101 degrees after taking ibuprofen 3 hrs prior. Also have severe fever and aches and pains accompanying the fever.
48 2021-02-10 pain in extremity 1/4 Vaccination. 12 hours later; arm pain, lump on arm with redness. Within 24 hours, lump was large... Read more
1/4 Vaccination. 12 hours later; arm pain, lump on arm with redness. Within 24 hours, lump was larger. Lymph nodes swollen. Lump was about size of a softball, all lymph nodes swollen. Symptoms about a week. Sought attention from NP. She stated to ice and Ibuprofen.
48 2021-02-11 weakness I received the vaccine at 7AM. I started feeling achy and had a headache by 10PM that night. My symp... Read more
I received the vaccine at 7AM. I started feeling achy and had a headache by 10PM that night. My symptoms worsened. By the weekend, I had lost my taste. I went for a covid test, it was negative. The following week I worsened. Cough, headache, body aches and diarrhea. By Friday 1/29/21 morning my daughter took me to the hospital. I do not remember going, I was diagnosed with altered mental status. I was dehydrated and a chest xray showed pneumonia. I was discharged on 1/31/21, diagnosed with vaccine reaction, pneumonia and altered mental status. I currently still have a cough, get easily tired, no energy.
48 2021-02-11 muscle spasms, seizure Chills, fever, muscle spasms, convulsing, splitting headache, bone and joint aches, muscle aches, ra... Read more
Chills, fever, muscle spasms, convulsing, splitting headache, bone and joint aches, muscle aches, rash on neck, chest and back, itchy back, swollen lymph nodes (under jaw) really large lymph node in groin area appeared 10 days post vaccination, trouble breathing, exhausted, light headed, nausea, white chalky furry tongue., diarrhea.
48 2021-02-12 weakness Headache, fatigue, weakness, chills, muscle pain in right arm it came in 18 hours after injection. ... Read more
Headache, fatigue, weakness, chills, muscle pain in right arm it came in 18 hours after injection. Symptoms lasted for 10 hours then it went away. I felt 100 percent better after good nights sleep.
48 2021-02-12 pain in extremity, migraine Neck stiffness, pain, Severe headache/ migraine overnight the night of receiving vaccine 1. Followin... Read more
Neck stiffness, pain, Severe headache/ migraine overnight the night of receiving vaccine 1. Following 2 days chills, fever 101.5, nausea, headache, joint pain, neck stiffness/pain, dizziness, difficulty concentrating. Swelling like a golf ball at injection site, purple skin and painful arm for 10 + days. Can feel a solid border of about 3 inch diameter around where the golf ball type knot was . Still sore when touched and visible bruise today.
48 2021-02-12 pain in extremity Intense soreness/pain in muscles ( arms, under breasts rib area, thighs, lower legs and ankles), bl... Read more
Intense soreness/pain in muscles ( arms, under breasts rib area, thighs, lower legs and ankles), blood in urine, pain in all major joints. difficulty walking and limited range of motion. Symptoms showed up after 7 days after vaccine was received. Presented to urgent care after test were don't I was hospitalized inpatient for 4 days. I was diagnosed with RHABDOMYOLYSIS, ABNL LIVER FUNCTION STUDY. CREATINE KINASE TEST OUTCOME WAS AT 41000.
48 2021-02-14 numbness, tingling Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial are... Read more
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
48 2021-02-14 muscle spasms Fevers to 104 degrees with delerium, severe muscle contractures of neck, upper back, and left arm. S... Read more
Fevers to 104 degrees with delerium, severe muscle contractures of neck, upper back, and left arm. Severe rigors. Involuntary spasms of back and neck lasting 1-3 minutes. Severe headache -frontal location and behind eyes. Possible febrile seizures per husband (temp 104.5, not responsive, repeated jerking of neck- resolved after placing in ice bath) . Fevers refractory to ibuprofen/tylenol. Initially continued for duration of 12 hours, remitted for 2 hours, then resumed for additional 24 hours. Intermittent muscle spasms with chills continued for another 12 hours, along with muscle soreness.
48 2021-02-14 pain in extremity 12 hours after second shot (1/29/2021): Chills for 5 hours, 101 fever; 24 hours after second shot (... Read more
12 hours after second shot (1/29/2021): Chills for 5 hours, 101 fever; 24 hours after second shot (1/30/21): 99 fever and throbbing pain in left and right forearms. Took 1 Tylenol on 1/30/21 that relieved the fever but not the pain in the forearms. Pain in forearms stopped on 1/31/2021.
48 2021-02-15 cold sweat Patient started complaining of cold sweats, chills, and sweating. She states she suffers from anxiet... Read more
Patient started complaining of cold sweats, chills, and sweating. She states she suffers from anxiety and thinks she is having an attack. Patient then escorted to the post vaccination area and asked to remove jacket, and given water. After 10 mins of observation she states she is feeling better. Patient then escorted to her car without any incident
48 2021-02-15 pain in extremity Tiredness began upon return home from shot location. Severe bone pain in right hip, thigh, knee, bo... Read more
Tiredness began upon return home from shot location. Severe bone pain in right hip, thigh, knee, both shoulders, chest pain when taking a deep breath and headache began approximately 15 hours after injection and continue at 3pm on Tuesday the 16th of February. Just not the "happy camper, I usually am. :(
48 2021-02-16 weakness Second vaccination given on the 02/12/2021 at 07:35. Began to have symptoms at 16:30 on 2/12/2021. B... Read more
Second vaccination given on the 02/12/2021 at 07:35. Began to have symptoms at 16:30 on 2/12/2021. Body aches, weakness, fever, chills, headache, and sore arm at injection site. These symptoms lasted until Monday 2/15/2021. I took Acetaminophen for the above symptoms. I left work early Friday night and called employee health Monday morning.
48 2021-02-16 weakness Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram ... Read more
Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram after finding brain bleed. Once released home from brain bleed patient developed petechai, weakness, shortness of breath
48 2021-02-16 numbness Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report... Read more
Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), intramuscular in the left arm on 06Jan2021 14:30 at a single dose for covid-19 immunization at a clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications received within 2 weeks of vaccination. On 06Jan2021 at 15:00, the patient experienced dysgeusia 20 min after exam lasting 1 min and left hemicranial numbness times 24 hrs. The patient still has mild residual numbness on left face. The events resulted in doctor or other healthcare professional office/clinic visit. The events were not treated. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the events dysgeusia and numbness with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
48 2021-02-16 pain in extremity, weakness Noted after first injection on 1/6/2021 within three hours, extreme fatigue, excessively sore arm an... Read more
Noted after first injection on 1/6/2021 within three hours, extreme fatigue, excessively sore arm and following morning significant brain fog and loss of energy. Noted after second injection on 1/27/2021, not much in the way of symptoms until about 3:15 a.m. on 1/28/2021 when was awakened from a sounds sleep with tremendous body aches, chills, fever, fatigue and headache. Took about 7 full days to completely recover. During weekly healthcare PCR testing, tested positive for COVID 19 on 2/10/2021. Two weeks later to the day. Week prior test was negative.
48 2021-02-16 pain in extremity After getting 2nd Pfizer COVID 19 Vaccine, late that night I became achey, sore arm , tired and inte... Read more
After getting 2nd Pfizer COVID 19 Vaccine, late that night I became achey, sore arm , tired and intense headache on February 10th. The next day and until Sunday of same week I was tired with intense headache. The headache didn't subside even with taking something for it. February 16th I returned to work and felt better with a light headache. I am a teacher. After 2 hours of being at work I became extremely dizzy as I went to sit down. The classroom flipped and I was dizzy. I was dizzy and had a hard time with balance. Another teacher took me home. I went to Patient First and they said I had positional vertigo.
48 2021-02-17 weakness, pain in extremity Increased soreness in my arm but it took a couple of weeks to develop significant weakness in my lef... Read more
Increased soreness in my arm but it took a couple of weeks to develop significant weakness in my left arm with pain. went to the doctor on 2/16 and Dr says its possibly a hematoma that is healing but should take up to 6 months to resolve.
48 2021-02-17 feeling cold, facial pain By 8 am, I recognized I realized I felt different - headache and foggy and tired. By 12 pm my headac... Read more
By 8 am, I recognized I realized I felt different - headache and foggy and tired. By 12 pm my headache became really severe - even when walking or chewing. My face was really hurting me; very tender by left eye. I felt so tired. I had to go home from work at 2:30. Felt very cold and I put on really warm clothes and got under three 3 blankets and I slept for three hours. I felt better by that evening, I slept normally that night. Face was very swollen under my eyes - two days after vaccine. (I have filler under my eyes - it's been a year since I had that put in.) Benadryl every six hours. It took 12 hours for pain to go away and for it to decrease. But it did help. Everything resolved.
48 2021-02-18 numbness Employee received the second dose of the Pfizer COVID vaccine. Employee felt deep bone and muscle p... Read more
Employee received the second dose of the Pfizer COVID vaccine. Employee felt deep bone and muscle pain right after injection. The next day she was unable to move arm away from her body. Took Tylenol and ibuprofen and range of motion improved. Over time pain increased to a constant pain. On 2/14/21 the pain increased to 7 out of 10 while she was laying down and the pain would wake her up at night. Employee reports pain was bad regardless if she was sleeping on right arm or not. Employee reports one day (2/7/21) she experienced numbness in right arm down to fingers tips. Employee was seen on 2/18/21 and was diagnosed with rotator cuff tendonitis and prescribed physical therapy and given a steroid injection: methylprednisone acetate.
48 2021-02-18 numbness I received my 2nd vaccine at 3:24pm. Around 3:30, I had a bitter taste in my mouth in the back of my... Read more
I received my 2nd vaccine at 3:24pm. Around 3:30, I had a bitter taste in my mouth in the back of my throat. I didn?t associate this with the vaccine. I left the facility around 3:45pm and started driving home. The right side of my face started to feel funny and felt numb. By the time I got home at 4:20, the whole side of my face felt numb. I could smile and talk. It felt like I had received Novocain from the dentist. I immediately started looking for phone numbers to call and tried to figure out what was happening. I left a message with a nurse hotline and left a message with the answering service at my primary care doctor?s office. Doctor FaceTimed with me for 7 minutes at 5:04 and said to go to the hospital.
48 2021-02-18 tingling within 10-15 minutes post vaccination the recipient notified nurse she had difficulty in breathing, ... Read more
within 10-15 minutes post vaccination the recipient notified nurse she had difficulty in breathing, complaining of rapid heart rate, not feeling well, lightheaded, chest pressure, tingling. No LOC. Called 911 , Epi auto injection given 0.3 mg; reported improvement in chest pressure and breathing shortly afterwards, taken to local hospital via EMS in stable condition. Total time in clinic: approximately 40 minutes from vaccination to EMS leaving.
48 2021-02-19 difficulty speaking voice change, cough, wheezing, bumps on tongue
48 2021-02-21 numbness I have numbness on the left lower side of my face. It is faint, however, noticeably different from t... Read more
I have numbness on the left lower side of my face. It is faint, however, noticeably different from the right side with no symptoms.
48 2021-02-21 pain in extremity rec'd 2nd dose of covid vaccine (Pfizer) on 1/8/21 & had prolonged upper arm pain / soreness x sever... Read more
rec'd 2nd dose of covid vaccine (Pfizer) on 1/8/21 & had prolonged upper arm pain / soreness x several weeks - unable to lift arm above shoulder - treated; heat / ibuprofen recovering
48 2021-02-21 pain in extremity swollen of the lymph node, pain on left arm that radiates to upper back
48 2021-02-21 pain in extremity I had a sore arm and a raised bump for about 3 days, It went away. 10 days later it is back. Har... Read more
I had a sore arm and a raised bump for about 3 days, It went away. 10 days later it is back. Hard raised bump at injection site.
48 2021-02-21 pain in extremity arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tende... Read more
arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tender left axillary and left supraclavicular nodes; chills; red x 5 days; This is a spontaneous report from a contactable healthcare professional (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249; dose 2) via an unspecified route of administration on 20Jan2021 at 1:30 PM (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension and mild asthma. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient took concomitant medications which were unspecified. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient previously took penicillin on unknown dates for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 (lot number: EL0104) on 30Dec2020 at 11:30 AM in the left arm as a single dose for COVID-19 immunization. On an unspecified date after the second vaccination, the patient had arm very painful, red for 5 days, and swollen and tender left axillary and left supraclavicular nodes. On 21Jan2021, 24 hours after the vaccine, the patient experienced chills lasting three to four hours. The patient did not have adverse effects at all after the first vaccine. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcomes of arm very painful and red, swollen and tender left axillary and left supraclavicular nodes, and chills were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
48 2021-02-21 pain in extremity Headache; Sore arm; This is a spontaneous report received from a contactable consumer. A 48-year-old... Read more
Headache; Sore arm; This is a spontaneous report received from a contactable consumer. A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache and sore arm on 27Jan2021. The outcome of the events was reported as unknown. Information about Lot/ Batch has been requested.
48 2021-02-22 hot flush, pain in extremity, breast pain Significant Left under arm swelling (area swollen approximately size of baseball in half) Significa... Read more
Significant Left under arm swelling (area swollen approximately size of baseball in half) Significant pain under left arm Redness along outside of left breast Pain in Left breast Pain Left shoulder to Left elbow Nausea and hot flashes - Mild
48 2021-02-22 numbness Pt received dose 2 of Pfizer Covid vaccine at 12:00pm and soon after reported symptoms of nausea, SO... Read more
Pt received dose 2 of Pfizer Covid vaccine at 12:00pm and soon after reported symptoms of nausea, SOB, wheezing, sweating, and numbness on left side from face to arm. Pt was given oxygen and 0.3mg of epinephrine was given intramuscularly at 12:05pm, followed by 25mg of diphenhydramine intramuscularly at 12:08, both administered by RN on site. Paramedics arrived at the scene at 12:05pm and took over monitoring of pt; pt was taken to ambulance at 12:10pm
48 2021-02-22 tingling Itchy, tingley, throat. Itchy bottom of feet. Drank water. Lasted ~20 minutes. No visible rash.
48 2021-02-23 flushing Redness, warmth, itchiness at injection site, 2 inch diameter redness. Facial flushing bilateral. Sh... Read more
Redness, warmth, itchiness at injection site, 2 inch diameter redness. Facial flushing bilateral. Shoulder lymph and neck lymph on left side.
48 2021-02-23 pain in extremity, numbness Headache and dizziness Diarrhea Nauseated Pain in arm and numbness from shoulder to elbow Fatigue
48 2021-02-24 feeling cold, tingling since about 3 days after the shot, my arm has been feeling a cold sensation in the deltoid area and ... Read more
since about 3 days after the shot, my arm has been feeling a cold sensation in the deltoid area and the forearm area. When I touch the arm, it is warm. I also have had a tingling in my left leg which comes and goes.
48 2021-02-24 flushing Patient reported feeling flushed during observation period. Pt. gets anxious with shots and has chr... Read more
Patient reported feeling flushed during observation period. Pt. gets anxious with shots and has chronic HTN. Pt. was hypertensive. Pt. stated she felt better and was advised to go home and relax, check BP when rested, and check with primary care provider. If needs emergent attention go to nearest ER.
48 2021-02-24 muscle spasms, pain in extremity Started 2/17/21 two days after vaccine shot. Left arm and shoulder pain upon waking. Intense burn... Read more
Started 2/17/21 two days after vaccine shot. Left arm and shoulder pain upon waking. Intense burning sensation across top of shoulder, down over shoulder blade and entire left arm, including hand. Sharp pain with cramping feeling. Difficulty finding a comfortable position because entire arm is tender, sore to the touch, as well burning feeling. Duration: 2/17/21 - still ongoing. 2 ER Visits. 2 PCP Visits
48 2021-02-24 tingling Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she bega... Read more
Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she began to look distressed and reported sensations of tingling in her elbows and behind her knees. No SOB, facial swelling, or heart palpitations. It was felt she may be nervous and she was given water and monitored closely. Vitals taken with O2 100%, HR 58, BP 134/89 Pt received Benedryl 25 mg when she began to note mild erythematous blotching on neck 10 min later vitals stable with bp 138/82 and pulse 62 Pt was given a second 25 mg dose to take if any symptoms worsened on way home- she was driving therefore I did not want to give her another dose at the time. She understands to call for emergency care if any SOB, facial swelling, or any distress Pt confirmed at 10 pm that she made it safely home with some improvement in her symptoms. I will follow up with her in the morning as well and will complete a VAERS report. I have educated her that at this time CDC would recommend not receiving the second vaccination, given potential allergic reaction within first 4 hours. We will review this again tomorrow I communicated with patient morning of 2/25/21- she states still mild tingling of arms but no new or worsening symptoms. She feels this is more consistent with anxiety and hesitant to not receive her second dose. I suggested she discuss with her primary care provider before her next visit and if she were to proceed with her second vaccination, I would suggest someone being with her to drive and she take 50 mg of benedryl 1 hr prior to vaccine. She was appreciative.
48 2021-02-25 burning sensation Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer.... Read more
Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer. A 48-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176) via an unspecified route of administration in right arm on 22Jan2021 12:00 at single dose for COVID-19 immunisation. The patient received the vaccine in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever, cough, diarrhea, swelling, burning on 22Jan2021 16:00. The patient didn't receive any treatment for events. The outcome of events was recovering.
48 2021-02-25 cold sweat Perspiration all over body, clammy, warm, BM
48 2021-02-26 feeling hot Patient reported feeling anxious and warm after receiving the vaccine. Her heart rate was 130 at th... Read more
Patient reported feeling anxious and warm after receiving the vaccine. Her heart rate was 130 at the time. Subsequent readings: BP 160/110 O2 Sat 95% HR 119 BP 196/120 O2 Sat 96% HR 125 Patient was transported to the hospital.
48 2021-02-27 numbness Lymphadenopathy started approx 22 hrs after first dose. Tender left axilla, radiation to left breast... Read more
Lymphadenopathy started approx 22 hrs after first dose. Tender left axilla, radiation to left breast and left scapula with numbness noted 5th digit left hand approx 48 hrs after injection. Tenderness, pain increasing daily. Currently only second day post injection.
48 2021-02-28 feeling of body temperature change, flushing Pt. received second dose of Pfizer vaccine on 2/24/2021, on 2/25/2021 at 12:30 pm she stated she bec... Read more
Pt. received second dose of Pfizer vaccine on 2/24/2021, on 2/25/2021 at 12:30 pm she stated she became flushed and was nausea's. Went to put her head down on desk, head hit desk and she fell to her knees. Pt. unsure if she lost consciousness. She described going form extremely hot to cold. Ambulance called and taken to ER
48 2021-02-28 flushing I waited in the holding area (mass vax clinic) for 20 min. No symptoms. The lights were very bad an... Read more
I waited in the holding area (mass vax clinic) for 20 min. No symptoms. The lights were very bad and bright flourescent so admittedly I was bothered by them or it could have been the beginning of the whooseyness from the shot. My husband picked me up in the car out front, we were driving and I began to get pressure in my sinuses and mostly the sides of my nose. I did have some head congestion but this feeling had never happened (it should be noted I had negative covid tests to make sure stuffy head was nog covid related). Then I felt pressure in my ears and my face began to feel flush as my cheeks. All of this began at about 35 minutes after the injection. Then my lips began to feel strange. It was a cross between tingly and numb. I made as many faces in the car makeup mirror to make sure my face muscles were moving properly And they were. But there was definitely numbness occurring in my mouth. Tingly-numbness. This all happened within about 10 min of the first onset. Then I noticed some splotchiness on my lower arms. Mostly my left (shot was given in right- no redness at the injection site). I also got some splochiness on my chest and neck. Cheeks were also ruddy and flush. I did NOT have any problem breathing or swallowing at anytime. Nor did my pulse race (other than from a pit of panic from nerves over the reaction). I didnt have a thermometer but don?t think I had a fever either. We pulled over and I called a nurse on call. She told me if things worsened to go to hospital. I did have a little bit of the feeling you get when you are about to pass out and you feel like things are closing in a bit. But it never got past about a 2 on a scale of 1-10. I decided I wanted something to eat (I HAD eatten before) and I went to get a sandwich. I still was a bit light headed but the symptoms did start to subside in about an hour. After that I was only tired and took a nap. Nothing else after those initial reactions.
48 2021-02-28 muscle spasms As anticipated, the day following the shot, I felt flu-like symptoms which subsided by late evening.... Read more
As anticipated, the day following the shot, I felt flu-like symptoms which subsided by late evening. Monday morning, I still felt fine, but by the afternoon, complete exhaustion over took me, muscle pain and cramps began, headache returned and I've essentially been on the couch or in bed since Monday Feb 22.
48 2021-02-28 pain in extremity Headache, chills, nausea, arm pain severe, tired. stared 24 hrs after Vaccination, Day after just pa... Read more
Headache, chills, nausea, arm pain severe, tired. stared 24 hrs after Vaccination, Day after just pain in Rt Arm.
48 2021-02-28 pain in extremity The vaccine was given on Tuesday, Feb 23, 2021, and on Wednesday 24, 2021 I had an awful headache, f... Read more
The vaccine was given on Tuesday, Feb 23, 2021, and on Wednesday 24, 2021 I had an awful headache, feelings of nausea, extreme tiredness, and arm pain. Wednesday 25,2021 most symptoms did not reoccur. Except now there is pain on my right side, back of the neck, shooting down the middle of the right shoulder blade. I took Midol for Wednesday's symptoms and went to bed before 8 pm. Woke up feeling better except for shoulder pain. Thursday I felt like I had a stiff neck so I took Ibuprophen and hubby massaged the area. Massage helped for about 30 min. The pain persisted on Friday still tried massage and Ibuprophen still very painful and now hard to be comfortable sitting and sleeping. Saturday morning I tried a warm shower and heat pad throughout the day pain still persisted. No ibuprofen and still massaged area. Sunday morning I soaked in the tub with Epsom salts and pain still continued throughout the day. Monday called dr. and she encouraged me to fill out a report and take vitamin C seems to think lymph nodes are clogged.
48 2021-03-01 weakness Dizziness tiredness headache nausea body aches no energy
48 2021-03-01 cold sweat 2/26 9:30 am: cold sweats, nausea, stayed home from work 2/27, 2/28: unable to perform normal ellipt... Read more
2/26 9:30 am: cold sweats, nausea, stayed home from work 2/27, 2/28: unable to perform normal elliptical cardio, could only do a few minutes than had to lay down due to extreme fatigue and shortness of breath 3/1: too fatigued to shower, change, or cook a meal. Stayed home from work. 3/2: Went to work. Too short of breath to walk across campus without sitting and taking breaks. Went to urgent care at noon, took PCR test for Covid, was negative.
48 2021-03-01 tingling 253p 154/99, 139 HR, 24 RR, 100% O2 ? dizziness, itching on arms and face, R arm numbness ? gav... Read more
253p 154/99, 139 HR, 24 RR, 100% O2 ? dizziness, itching on arms and face, R arm numbness ? gave diphenhydramine elixir 25 mg x1 307p 120 HR, trouble with BP cuff 313p R arm numbness, legs heavy, face and mouth tingling ? gave diphenhydramine elixir 25 mg x1 315p 142/89, 110 HR ? legs ?wonky?, R arm numbness remains, itching improving 330p symptoms significantly improved, ?feeling better?; family member with patient and able to drive patient at home and continue observation Telephone follow-up performed at 430p. No problems.
48 2021-03-02 cold sweat after injection pt complained of dizziness and not feeling well. initial vital BP 66/52 HR 68 RR 15 ... Read more
after injection pt complained of dizziness and not feeling well. initial vital BP 66/52 HR 68 RR 15 spO2 97% RA. pt was in sitting position. became clammy, diaphoretic, blurred vision, and feeling worse and passed out. pt assisted to floor. MD called to bedside, 0.3 epi pen given to left thigh. no respirstory distress noted. fire and EMS on scene to transfer to ED. pt now a&ox4. VSS now.
48 2021-03-02 pain in extremity Sore arm, headache, stiff neck
48 2021-03-02 cold extremities, tingling mild tinging in her left arm; tingling in her feet; tingling in her feet and they also feel cold; Th... Read more
mild tinging in her left arm; tingling in her feet; tingling in her feet and they also feel cold; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on the left arm, on 31Jan2021 13:30, at single dose, for covid-19 immunization. Medical history included penicillin allergy. Concomitant medications included temazepam; spironolactone and; silybum marianum (MILK THISTLE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received the vaccine in the hospital. It was reported that shortly after the vaccination, on 31Jan2021 the patient experienced mild tinging in her left arm that went away; but when she woke-up she noticed tingling in her feet and they also feel cold on 31Jan2021. The outcome of the event mild tingling in her left arm was recovered on 31Jan2021. The outcome of the events tingling in her feet and they also feel cold was unknown. The patient has not been COVID-tested post-vaccination.
48 2021-03-04 discomfort It started out as an itchy area under the band aid. I took the band aid off and the itching got wors... Read more
It started out as an itchy area under the band aid. I took the band aid off and the itching got worse and went down my arm. A minute left after waiting 15 minutes I let the nurse know the reaction I was having ( bad itching), she looked at it and was red. She said it could be a site reaction and gave me an ice pack. Another nurse came to check on, and I told her I was really thirsty. By the time she got back my lips were feeling very heavy, lips itching and difficult to swallow, then my whole chest was covered in a red rash. With in a couple minutes there was a paramedic there and was more difficult to swallow, they tried to give me Benadryl thru an IV and blew my vain. So he asked me for a IM shot of Benadryl, I said yes and took me to the ER. By the time got there the Benadryl wore off and my lips got itchy and they took me right to the room and Dr gave me IV Solumedrol and Benadryl. They watched me for two hour sin the ER , they released me with 3 days of prednisone, Epipen, Benadryl. I went to the pharmacy (15 minute drive from ER) and both my eyes starting swelling, so I took 50mg of Benadryl capsule and the next day I started the prednisone, I had to take Benadryl every 3 hours for the next couple days because my eyes would start swelling.
48 2021-03-04 feeling hot hot, dizzy, redness, headache
48 2021-03-04 flushing Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injecti... Read more
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Error: Wrong Route (SC, IM, etc.)
48 2021-03-04 muscle spasms DIZZINESS, NAUSEA, CRAMPS, DIARRHEA, HEADACHE, FATIGUE.
48 2021-03-04 pain in extremity, numbness A SHARP PAIN AND NUMBNESS IN INJECTED ARM IMMEDIATELY AFTER THE INJECTION, 25 MINUTES AFTER THE INJ... Read more
A SHARP PAIN AND NUMBNESS IN INJECTED ARM IMMEDIATELY AFTER THE INJECTION, 25 MINUTES AFTER THE INJECTION I EXPERIENCED A HEADACHE, CHEST PAIN, DIZZINESS, THROAT SWELLS UP AND IT'S HARD TO SWALLOW, AND BLURRY VISION.I TOOK SOME BENADRYL AND MY THROAT STOPPED CLOSING UP. I WENT HOME AND LAID DOWN. MY ARM IS STILL NUMB BUT THE PAIN HAS RECEDED. MY ARM ALWAYS SWELLS UP WHENEVER I RECEIVE AN INJECTION. 2 HOURS LATER THROAT IS STILL A LITTLE SWOLLEN, AND I HAVE A SLIGHT HEADACHE. CHEST STOPPED HURTING. LEFT ARM IS STILL NUMB.
48 2021-03-04 pain in extremity Around 2/13/21: Right Hand second finger with rash, swelling, mottled color with redness on knuckle ... Read more
Around 2/13/21: Right Hand second finger with rash, swelling, mottled color with redness on knuckle and dorsal side of skin from knuckle to nail. Same day I developed a growth on right hand middle finger similar to a cyst or nodule. 2-3 days later I developed a reddened raised lesion on my left hand 4rth finger dorsal side near the joint. Doctor looked at it over zoom but not in person and thought it was contact dermatitis or allergic dermatitis from hand sanitizer or glove use. Steroid cream triamcinolone and cloberasol have been tried for 1.5 weeks but not working. After second dose of vaccine I developed pain and redness to left hand 4th finger knuckle near where the previous lesion had been. And the cyst on my right hand middle finger is growing and taki bf on a weird shape, its surface area has increased and these creams are not helping.
48 2021-03-04 pain in extremity Arm Pain - onset 6h post injection Body aches - 24h post injection Arm pit pain & swelling - 34h pos... Read more
Arm Pain - onset 6h post injection Body aches - 24h post injection Arm pit pain & swelling - 34h post injection Headache -34h post injection Injection site swelling/lump - 38h post injection Lightheaded - 44h post injection
48 2021-03-05 flushing Flushing, history of anxiety. BPs 148/80 (pulse 84), 140/90 (pulse 74). O2 sat 97%.
48 2021-03-05 muscle twitching, tingling Acute onset of fatigue approximately 48 hours after receiving the vaccine on 30/Jan/2021. Fatigue ha... Read more
Acute onset of fatigue approximately 48 hours after receiving the vaccine on 30/Jan/2021. Fatigue has worsened and persists to this day. Acute onset of palpitations 48 hours after vaccine and lasting approximately 20 min., headaches lasting 3 days and severe heartburn lasting 3 days. Coarse fasciculations of left pectoralis muscle onset 50 hours after vaccine. This progressed over ensuring days to involve other muscles both above and below the diaphragm including gluteals, gastronemius muscles, abductor hallucis longus, left first dorsal interosseous, deltoids, triceps, various abdominal and spinal muscles, and more recently the left masseter. The fasciculations persist to this day. Muscle pains started 2 days after onset of the fasciculations and are moderate-severe and worsened by exercise. I experienced tingling at the lower limbs on 6 occasions and transient disorientation one day on my way to work. My vision has been a bit blurry at times. i have been moody and short-tempered at times.
48 2021-03-05 pain in extremity, muscle spasms, tingling, numbness Patient's symptom log: 1/21/2021: 1st dose of COVID-19 vaccine (Pfizer); just sore arm 1/27/2021: N... Read more
Patient's symptom log: 1/21/2021: 1st dose of COVID-19 vaccine (Pfizer); just sore arm 1/27/2021: Numbness felt in front left thigh 1/27/2021 - present: - continued numbness in legs that comes and goes - numbness in arms; both but more in left - pins and needles in both hands, feet - hands fall asleep during night - back spasm overnight; left side of back - numbness in back; both left and right sides - middle and upper back - in back, stiffness/achiness, not quite pain - back sensations feel like a radiating spasm that comes and goes - new this week - pins and needles (slight) in trunk - at work, have felt slight difficulty typing with left hand Areas Affected: - neck (slight soreness) - shoulders (stiffness and achiness/numbing) - back (achiness, stiffness, spasms, numbness) - arms (stiffness, achiness, pins and needles, numb) - hands (pins and needles, possible muscle loss) - buttocks (numbness) - legs (pins and needles, stiffness, numbness, soreness) - feet (pins and needles, numbness) - face (slight numbness on right slide)
48 2021-03-06 fibromyalgia Dizziness, fibromyalgia flare up, extreme fatigue
48 2021-03-06 pain in extremity Dizziness, nausea, fatigue, fever, chills, muscle soreness, pain in left hand, swollen and painful a... Read more
Dizziness, nausea, fatigue, fever, chills, muscle soreness, pain in left hand, swollen and painful armpit.
48 2021-03-06 pain in extremity Upon receiving vaccine I immediately had severe arm pain. The injection itself was extremely painfu... Read more
Upon receiving vaccine I immediately had severe arm pain. The injection itself was extremely painful and immediately afterwards pain worsened from elbow to top of shoulder and has not let up. I have zero mobility and the severe pain is not responding to over the counter pain relief medicine.
48 2021-03-07 pain in extremity, feeling hot fatigue; warming feeling; sore arm; joints sore; This is a spontaneous report from a contactable hea... Read more
fatigue; warming feeling; sore arm; joints sore; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el3248 and expiry date: unknown), via an unspecified route of administration on the left arm, on 02Feb2021 11:00 at a single dose for COVID-19 immunization. The first dose was received on 12Jan2021 11:00 on the right arm (lot number: ej1656). Medical history included cancer. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and no other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, warming feeling, sore arm, joints sore on 02Feb2021 15:00. No treatment was received for the events. Outcome of the events was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. Covid test was on 03Feb2021 with unknown results. The reporter considered the events non-serious.
48 2021-03-08 migraine Severe headache, nausea, malaise, migraine ( 2 weeks), and fatigue. Took excedrin and imitrex for 2 ... Read more
Severe headache, nausea, malaise, migraine ( 2 weeks), and fatigue. Took excedrin and imitrex for 2 weeks. Intake of lots of fluids and bed rest. Telehealth visit with doctor.
48 2021-03-08 muscle twitching at 6 am this morning I felt that the muscle on my left arm on the injection site is twitching and it... Read more
at 6 am this morning I felt that the muscle on my left arm on the injection site is twitching and it continues to twitch off and on up to the time I am writing this note at 2:20 pm
48 2021-03-08 pain in extremity, nerve pain, numbness Covid arm developed last night and is getting worse at the injection site. I have extreme dizziness... Read more
Covid arm developed last night and is getting worse at the injection site. I have extreme dizziness like vertigo, extreme fatigue, throwing up and nausea and my arm symptoms are huge welt that is burning hot at the injection site, cannot lift my arm without pain, numbness and nerve pain running down the arm down to the elbow. I feel faint. I am at home laying down with ice on it, Tylenol and Benadryl. I cannot make it to the doctor as I live alone and have epilepsy.
48 2021-03-09 weakness Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakne... Read more
Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakness Requires emergency room visit or hospitalization Shortness of Breath, Myalgia
48 2021-03-09 cold sweat excess phlem; Exhaustion; Body aches; fever; chills; cold sweat; This is a spontaneous report from a... Read more
excess phlem; Exhaustion; Body aches; fever; chills; cold sweat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3247), via an unspecified route of administration on right arm on 04Feb2021 10:00 (at age of 48 years old) at single dose for COVID-19 immunization. Medical history included spinal stenosis, liver hemangiomas, uterine fibroids, parapelvic and renal cysts, complex left ovarian cysts, PTSD (Post-traumatic stress disorder), pap smear atypical cells of undetermined significance, endometrial cells, bacterial vaginosis, HPV (Human papilloma virus infection), osteopenia, anemia, patellar tendenitis, right hip impingement, left shoulder impingement syndrome, microscopic hematuria, hiatal hernia, cricopharyngeal spasms and allergies to contrast die. Concomitant medication included pregabalin (LYRICA), sertraline hydrochloride (ZOLOFT), colecalciferol (VIT.D3) and glutathione. The patient previously received first dose of BNT162B2 (Lot number=EL3247) on 15Jan2021 at 10:45 AM on right arm for COVID-19 immunization. The patient experienced excess phlem, exhaustion, body aches, fever, chills, cold sweat on 04Feb2021 17:00. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment from events. The outcome of events was recovered in Feb2021.
48 2021-03-09 migraine Rash around injection site Rash around neck Migraines Nausea Fever Ache
48 2021-03-09 tremor At 11:30pm on 3/9/2021 over 12 hours after my 1st COVID-19 vaccine , I awakened from my bed and went... Read more
At 11:30pm on 3/9/2021 over 12 hours after my 1st COVID-19 vaccine , I awakened from my bed and went into my bathroom to urinate. As I was using the restroom, I noticed my arm where I got the vaccine was very sore, and raised it slightly. Immediately after raising my arm, I became very dizzy and passed out, fell off of the toilet and hit the left side of my temple and eye on the marble ledge of my shower. As I came to, my whole body had chills and I was shaking. I applied a cold compress and took 2 Tylenol. I alternated between sweating and chills for the rest of the night. The next morning I had a headache and felt fatigued, but the dizziness had subsided and I rested.
48 2021-03-10 discomfort 4:39 pm - Client complained "heaviness in neck region". There was no rash or tingling sensation. Cl... Read more
4:39 pm - Client complained "heaviness in neck region". There was no rash or tingling sensation. Client was alert and oriented and left at 4:53 pm.
48 2021-03-10 facial pain Severe left ear pain and pain on the left side of the face, including the neck.
48 2021-03-10 pain in extremity Severe leg pain (both), overall muscle soreness, diarrhea, nausea, vomiting, coughing, and tiredness... Read more
Severe leg pain (both), overall muscle soreness, diarrhea, nausea, vomiting, coughing, and tiredness.
48 2021-03-10 pain in extremity COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat;... Read more
COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat; Cough; Sore throat; Dizzy spells; Runny nose /nose was a faucet; Little sore arm; Fatigue; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient (weight: 148.32 kg, height: 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9262) intramuscularly, in the left arm, at single dose, on 28Jan2021, at 13:30, for COVID-19 immunisation. Relevant medical history included light Crohn's disease from an unspecified date. Concomitant medications included oral fexofenadine hydrochloride (ALLEGRA) 60 mg, twice daily (60 mg, 1 tablet every 12 hours), from 02Feb2021 to 05Feb2021, for nasal congestion; oral paracetamol (TYLENOL, capsule) 500 mg capsule (she took 2 as needed), from 02Feb2021 and ongoing, for fever and headache; salbutamol (ALBUTEROL) 90 mcg, 2 puffs every 4-6 hours as needed, from 06Feb2021 and ongoing, for breathing problems and oral benzonatate 100 mg, thrice daily (100 mg capsules, 1 by mouth three times daily as needed) from 06Feb2021 and ongoing, for cough. On an unspecified date, in Feb2021, the patient developed little sore arm and fatigue. On 01Feb2021, the patient experienced runny nose, nose was a faucet. On 02Feb2021, she had little scratchy throat, cough, sore throat and dizzy spells. On 04Feb2021, she threw up and on 05Feb2021, the patient experienced fever (she had temperature at 102.7 Fahrenheit) and then was hospitalized. Post the vaccination, the patient has been tested for COVID-19 on 05Feb2021 and resulted positive and pneumonia requiring hospitalization. She was admitted on the 05Feb2021 discharged on the 09Feb2021. Chest x-ray and CT chest performed on 05Feb2021 showed pneumonia. Body temperature on 05Feb2021, at night, was 102.8 Fahrenheit. Oxygen saturation (pulse ox) showed the following value: 80s, 84 and 93 on an unspecified date, in Feb2021. Emergency Room Visit and Physician Office Visit required for runny nose, throat irritation, cough, sore throat and pneumonia. Treatment was received for COVID-19 pneumonia, fever, runny nose, throat irritation, cough and sore throat. She was supposed to get the second vaccine on the 18Feb2021. The patient recovered from fever on 07Feb2021, did not recover from dizzy spells, while clinical outcome of the other events was unknown at time of this report.
48 2021-03-10 tenderness, numbness Angioedema of the right side of the patient's face from the inferior orbit down, sparing the upper l... Read more
Angioedema of the right side of the patient's face from the inferior orbit down, sparing the upper lip, and involving the lower lip. Accompanied by numbness for a few hours which then subsided, with lingering tenderness upon palpation.
48 2021-03-11 weakness chills, body aches, extreme fatigue, could not use/move right arm, weakness
48 2021-03-11 flushing, weakness Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Im... Read more
Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Immediately afterwards, patient was dizzy, flushed feeling, tingling of my lips, and swelling of the right side of my face. These symptoms were not enough to seek medical attention but were there. After that, I had swelling down my arm and into my right hand, up my neck and face, up and down the right side of my back. I have been extremely tired and weak feeling. Some improvement but I am still really sore and the RSD is starting to act up. I have called into work, been eating well, drinking a lot or water, moving as much as I can, and using Advil and Tylenol for pain management. Called into work for three days.
48 2021-03-11 numbness Immediate numbness of left arm. After 2 days left face numbness
48 2021-03-11 pain in extremity My arm has been hurting since I had the 1st doce. When I lift up, it hurts so much. There's no swole... Read more
My arm has been hurting since I had the 1st doce. When I lift up, it hurts so much. There's no swolen or rashes. Just pain. Why is that so after so long?
48 2021-03-11 pain in extremity Terrible pain and swelling under my left arm (arm pit area) with pain shooting into my left breast. ... Read more
Terrible pain and swelling under my left arm (arm pit area) with pain shooting into my left breast. Pain at the injection site that traveled through my arm to the joints in my wrist.
48 2021-03-11 tingling I woke up with a rash on chest tingling and burning. On Friday I had a Telehealth appt was diagnose... Read more
I woke up with a rash on chest tingling and burning. On Friday I had a Telehealth appt was diagnosed with Shingles.
48 2021-03-12 unresponsive to stimuli, numbness, tingling Person noted to be drowsy and minimally responsive. Epinephrine 0.3mg IM and diphenhydramine 25mg I... Read more
Person noted to be drowsy and minimally responsive. Epinephrine 0.3mg IM and diphenhydramine 25mg IM administered and within two minutes of the epinephrine the patient started talking and saying she was feeling a little better. Reports that she started feeling numbness and tingling in her lower extremities which progressed to her upper body (bilateral). Also reports hx of hypoglycemia and states she ate and drank approx 90 minutes before the event. Reports this happened one other time when she was exposed to smoke in her classroom and that she was admitted to a local hospital for three days. VSS 124/72, 90, 100% ORA. Apple juice given after patient became more responsive. Transported via EMS to ED for eval, alert, oriented, stable, and in no apparent distress.
48 2021-03-13 pain in extremity arm soreness, very mild dizziness, fatigue
48 2021-03-13 pain in extremity Headache w nausea started in 5 min. At about 15 min chest was tight. By 45 min neck muscles were e... Read more
Headache w nausea started in 5 min. At about 15 min chest was tight. By 45 min neck muscles were extremely tight. By about 90 min slight wheezing and all over joint pain. Skin itching in various places. Took Benadryl. At night my whole body was tight muscled. Felt much better next day other than continued fatigue , sore arm and mild flu feeling. No fever or rash. The form
48 2021-03-14 feeling cold On 3/13/21 I started to notice a buzz sound in ny head when trying to take a nap. A High pitch soun... Read more
On 3/13/21 I started to notice a buzz sound in ny head when trying to take a nap. A High pitch sound like static. It hasn?t gone away since then. Im seeing an ENT on 3/16/21 to have this checked. About 25 minutes after my covid shot I felt a strong cold feeling on the top of my head for about 30 -60 minutes . It went away. Now I wonder if this was also related.
48 2021-03-14 hot flush, tingling, pain in extremity pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore... Read more
pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore R arm; LOSS OF TASTE; partial throat swelling 90 min after 2nd injection; drowsy; This is a spontaneous report from a contactable health care professional. A 48-years-old female received 2nd dose, bnt162b2 (BNT162B2) Lot number= Lot EL3247 , intramuscular in right arm, on 29Jan2021 at 15:30 as a single dose for COVID-19 immunization . Medical history included sjogren's syndrome, irritable bowel syndrome , raynaud's phenomenon, fibromyalgia , food allergy to peanuts, honey, oranges, strawberries, lobster, molasses, brown sugar, cinnamon. She had the first dose of COVID-19 on 08Jan2021 at 1545 in the right arm. There were no other vaccinations given in the past 4 weeks. She was not tested for Covid prior to vaccination.Concomitant medication included collagen (COLLAGEN), medium-chain triglycerides (MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES]), ergocalciferol (VIT D), fish oil (FISH OIL). The patient previously took gluten and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. Course as follows: On 29Jan2021: partial throat swelling 90 min after 2nd injection. Took 50mg Benadryl. Became very drowsy and went to bed at 7:30pm. 30Jan2021: Woke at 5am w/chills, headache, body aches, sore R arm, temp of 101.3, dry mouth & LOSS OF TASTE. By 11:30am, fever went up to 103.5. Took 400mg ibuprofen. Went and got a Rapid Covid test (It was negative/undetectable). 4pm diarrhea. Took 400mg Ibuprofen at 6pm and 11:30pm. 31Jan2021: fever 100-101, headache, body aches, sore R-arm, diarrhea, loss of taste, sore throat. 01Feb2021: fever 99-100, headache, body aches, sore R-arm, dry mouth, loss of taste, sore throat. Went to get a 2nd Covid Rapid Test to r/o a false negative (It was negative/undetectable again). 02Feb2021: Fever 99-100, headache, dry mouth, loss of taste. 03Feb2021: temp normal, headache, dry mouth, loss of taste. 04Feb2021- 07Feb2021: temp normal, headache, dry mouth, weird continuous hot/cold flashes, pins & needles tingling all persist. Appt w/PCP scheduled for 17Feb2021. The patient was not hospitalized for the events. The patient was tested for Covid-19 on 01Feb2021 and was negative. The outcome of the events was recovering.
48 2021-03-14 migraine Sever two day migraine starting the day after injection, fever, chills, myalgia in lower back
48 2021-03-15 numbness Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes... Read more
Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes of injections.
48 2021-03-15 tingling, cold sweat, tremor 2:17 pm, Suddenly client felt faint, Layed her in exam room table gave, water & crackers, 2L 02 via ... Read more
2:17 pm, Suddenly client felt faint, Layed her in exam room table gave, water & crackers, 2L 02 via adult face mask sat 100%. vitals; 139/82 HR 98. 2:30 felt, cold & clammy, shakey and tingling body & nausea vitals 125/70 HR 95 O2 sat 100% . By 3:00 previous symptoms subside , new symptoms dry mouth, headache 7/10 and nausea vitals 145/85 HR 105, taken of 2L 02. Called 911, emergency transport to AV emergency room. Patient choose to be driven to AVH emergency room by daughter who was at her mothers bedside during observation.
48 2021-03-16 feeling hot, tingling Feet were red and hot, tingly No interventions other than monitoring reaction dissipated
48 2021-03-16 hot flush After receiving the first dose of the Pfizer vaccine, my face immediately went all red and got hot. ... Read more
After receiving the first dose of the Pfizer vaccine, my face immediately went all red and got hot. I stayed at the pharmacy for 30 minutes to ensure I didn't have an allergic reaction like a breathing issue. I had my epi pen with me just in case. It was loud in the pharmacy so I didn't notice it at first but once I got outside and was in the car, my ears were ringing. When we got to the restaurant to eat, we were the only family in there and it was pretty quiet. The ringing was really high pitched and loud. For the following two weeks it did not stop, day and night. I contacted my primary and had a telehealth appt and also went physically in to my ENT's office. I also tried acupuncture to see if that would take away the ringing. The acupuncture seemed to lower the pitch in my ear but it was still present. 2 hours after I left the office the pitch was back to a high pitch ring again. I cancelled my appointment today for 3/18 for the second dose because no one can assure me that this ear ringing will go away and the doctor's are unsure of whether the second dose will trigger a worse condition. I had a hearing test on 3/16 at my ENT's office and I couldn't hear some of the sounds because of the ear ringing but I did pass the test at the very line of baseline normal. My ENT is unsure if I will lose hearing due to this vaccine.
48 2021-03-16 numbness, burning sensation, pain in extremity Got vaccine at 9:00 AM and had no problems, and started to feel pain towards the end of the day, wen... Read more
Got vaccine at 9:00 AM and had no problems, and started to feel pain towards the end of the day, went to bed. On 3/9/21 had pain right below the injection site and above the elbow/forearm there is a burning sensation/pain in the bone and the whole arm below the injection site on 3/9/21. She has been applying heat/cold, which has helped but feels heavy pain into the bone. On 3/10/21 she could feel a numb tingling sensation on her index finger like a Lidocaine injection numbness. This has extended the middle finger and thumb as well on the left side. She works for Cardiologists which she consulted and they told her that it looked like a hematoma, and they looked at her injection site a week after the injection and advised her to keep taking Benadryl. She then spoke with another doctor and he wrote her a prescription for Gabapentin which she took yesterday at 7:00 PM and then again at 2:30 AM, and also gave her a Medrol dose pack, which she has not started yet. He also felt that they injected her way to deep and hit a nerve. Today she felt as if her pain is much better from a 9 to a 5/6, but still feels the heaviness pain, and also still has the numbness on the index and middle finger. On Saturday 3/13/21 she got a Salon patch and covers her whole arm other than the injection site, around the elbow area to her hand, which h as cooled the area but not improved the sensation a lot. The area under her arm from the injection site also has a burning pain as well.
48 2021-03-17 feeling hot loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with... Read more
loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with swelling; severe pain under arm in armpit with swelling; hot feeling on skin; extreme fatigue; had some itchy skin and redness an hour after shot, especially on both arms; had some itchy skin and redness an hour after shot, especially on both arms; Extremely nausea/Often nauseous; insomnia; mild diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809; expiration date not provided), via an unspecified route of administration (anatomical location: arm right) on 09Feb2021 18:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included asthma and known allergies to sulfa drug both from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date not provided) on 19Dec2020 02:30 pm (vaccination location: left arm) and experienced dizziness, extreme itchy skin, headache, and fatigue reported as 'After 1st shot had dizziness and extreme itchy skin 1 hour after shot for approx 2 hours before it ended, then headache and fatigue for 1-2 days. However, after 48 hours all effects from the 1st shot were gone'. The patient experienced spontaneous bleeding under skin by right eye on 14Feb2021. Patient's clinical course is as follows: After 2nd shot, patient had some itchy skin and redness an hour after shot, especially on both arms that lasted a couple hours (started at 7PM and stopped at 9PM). Patient also had extreme fatigue everyday since 11Feb2021, as well as insomnia especially during the first 48 hours. Also had total loss of appetite the past 8 days (17Feb2021), extremely nauseous and mild diarrhea everyday since immediately after 2nd shot until now (8 days later) with no improvement. Often nauseous until close to the point of vomiting. 2 days after 2nd shot started having severe pain under arm in armpit area with swelling and hot feeling on skin. Developed some spontaneous bleeding under skin by right eye about 5 days (14Feb2021) after shot which has now gone away. Fatigue and health is poor with no improvement; most effects seem to be getting worse instead of improving each day. Patient was not COVID tested post vaccination. It was reported that no treatment was provided for the events. Outcome of the event 'had some itchy skin and redness an hour after shot, especially on both arms' was recovered on 09Feb2021; outcome of the event 'spontaneous bleeding under skin by right eye' was recovered; outcome of the remaining events was not recovered.
48 2021-03-17 feeling hot Adverse reaction after receiving the COVID-19 vaccine in Vaccine Clinic. Medications: Fludrocort... Read more
Adverse reaction after receiving the COVID-19 vaccine in Vaccine Clinic. Medications: Fludrocortisone 0.1mg (pt took med prior to vaccine) No current outpatient medications on file. Allergies: Pt reports anaphylaxis x2 as a child after receiving vaccine (varicella and MMR) Not on File Medical history: "low blood pressure" per pt No past medical history on file. This was vaccine dose 0.3ml Pfizer Lot# ER2613 given @ 2:55pm Describe adverse reaction: Per pt "itchy throat" and "knot in my throat" Tachycardia to 110's Hypertension 120-150/80' Employee was monitored for 30minutes. Vaccine @ 1455 and pt started to c/o "itchy throat" @ 1515. Pt requested water and was able to swallow w/o difficulty. C/o feeling dizzy and warm. VS continued to be taken while pt sat on gurney. MERT called @ 1527 and arrived @ 1534. Pt taken to ED. AOD present @ 1530 and escorted pt via gurney to ED w/ MERT @ 1540. A/O x3, following commands, RR 20's. No difficulty breathing. 15:21 128/86 100% RA HR107 RR20 15:27 157/84 100% RA HR100 RR20 15:33 125/85 100%RA HR114 RR20 Anaphylaxis symptoms: Per pt "itchy throat" and "knot in my throat" Tachycardia to 110's Hypertension 120-150/80' Anaphylaxis plan: Anaphylaxis kit within reach. Pt also brought her own Epi pen. Not used. MERT called. Vasovagal symptoms: Dizziness Vasovagal plan: Pt remained seated and gurney brought to clinic. Administration error: NONE MERT called YES @ 1527 Transferred to ED VAERS report number: Email sent to OHS and patient documented in adverse reaction log.
48 2021-03-17 tingling Within 30 minutes of receiving the first dose of the COVID vaccine, I ban to feel tingling on the le... Read more
Within 30 minutes of receiving the first dose of the COVID vaccine, I ban to feel tingling on the left side of my face. Within another 30 minutes, I had multiple blisters in the same spot. Within another 2 hours, the lymph nodes on the left side of my neck were swollen.
48 2021-03-18 feeling hot As soon as I received my vaccine my face, specially cheeks felt very hot, I was wearing a face mask ... Read more
As soon as I received my vaccine my face, specially cheeks felt very hot, I was wearing a face mask so not sure f that had anything to do with that feeling. I sat down in the wait area for the required 15 minutes and left. while walking towards my car I was nauseous and drank some water to help ease my stomach. When I got home my stomach felt like if I had a nod at the top of it as well as it got a little upset. I noticed I had blotchy arms the following morning.
48 2021-03-19 weakness, pain in extremity, migraine, muscle spasms Approximately thirty minutes after the injection, i started having right leg muscular pain and spasm... Read more
Approximately thirty minutes after the injection, i started having right leg muscular pain and spasms. The next morning I woke up with with full body spams, extreme fatigue and severe migraine. The left side of my face has continued spasms that has not stopped and under my left eye continues to spasm and has spasmed non stop. I'm feeling very weak. My symptoms have not improved and it has been over a week.
48 2021-03-19 pain in extremity 2/17/21: slight burning sensation on skin; itchy eyes 2/18/21: itchy eyes, sore deltoid, sore rt hip... Read more
2/17/21: slight burning sensation on skin; itchy eyes 2/18/21: itchy eyes, sore deltoid, sore rt hip, sore 1st rt finger 2/19/21, 2/20/21: sore under rt upper arm 2/21/21: greater pain under rt upper arm, took acetaminophen 2/22/21-3/7/21: pain extending from rt underarm to rt wrist upon extension/reaching 2/24/21-2/26-21: rt carpal tunnel ache 2/28/21: lymph nodes not as sore 2/28/21-3/11/21: puckered skin, rt upper arm
48 2021-03-20 nerve pain Metallic taste in mouth, severe fatigue, muscle, joint, and nerve pain, nausea
48 2021-03-21 pain in extremity Right arm pain that continued to worsen as the day went on, progressing across my back and then legs... Read more
Right arm pain that continued to worsen as the day went on, progressing across my back and then legs. Felt the worst about exactly 24 hrs after the injection. Felt like a truck ran over me. Took ibuprofen and felt much better the next day.
48 2021-03-21 tingling 3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and n... Read more
3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and neck became very sore and two small bumps appeared on the back of my neck. The bumps became very sore and my lymph nodes began to swell. All symptoms were on the left side of my body, which is the side I received the injection. 3/19: The two bumps multiplied and I had them behind my ear, in my hairline, on the back and front of my neck, trailing to my shoulder and a patch on my back. The bumps were painful and hot. I vomited 4 times that day, ran a 100 temp for a short period of time, had chills, body aches, very swollen lymph node, mild headache, and a very stiff, sore neck. All of this occurred on the left side of my body. 3/20: The bumps continued to increase in size, pain and number. The swollen glands, sore and stiff neck persisted. I was very tired and felt nausea at times. 3/21: I woke with an extremely sore and stiff neck, sore throat and new patches of bumps. I sought medical treatment and was diagnosed with Shingles. I was 100% healthy prior to the shot. I've never had Shingles before. I am now on medication to treat the outbreak.
48 2021-03-21 tremor, paralysis I'm paralyzed; Anxiety; chills; Shaking but not fever; This is a spontaneous report from a contactab... Read more
I'm paralyzed; Anxiety; chills; Shaking but not fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. Medical history included hypertension, brain injury (doesn't have a good memory), menopause and menopausal problem. The patient is on a lot of medications (unspecified medication) for her Brain injury. The patient previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient had her second dose on 06Mar2021 and had been having bad like chills and shaking too but not fever. The patient was shaking bad (not clarified) there but she doesn't know if it's part of her menopausal problem from my menopause (as reported) but she was shaking. The patient mentioned that she was paralyzed. The patient stated that she was taking some Ativan for anxiety, she has been so anxious; and she had been taking Benadryl. The outcome of the events was unknown.
48 2021-03-22 weakness I received my first dose on 3/3/21 and the adverse reaction occurred from 3/10/21 through 3/19/21. ... Read more
I received my first dose on 3/3/21 and the adverse reaction occurred from 3/10/21 through 3/19/21. My side effects included: headache, fatigue, congestion, dizziness, nausea, diarrhea, chills, myalgia(lots of muscle pain), joint pain and swelling, overall weakness throughout body.
48 2021-03-22 pain in extremity Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarr... Read more
Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarrhea, chills, disorientation, difficulty breathing
48 2021-03-22 tingling The patient was in observation and complained of a sudden headache and left arm tingling. The patie... Read more
The patient was in observation and complained of a sudden headache and left arm tingling. The patient was assessed and the patient refused transport. The patient signed out against medical advice. See paramedic PCR for further detail.
48 2021-03-22 seizure, tremor Seizure the next day plus headaches, tremors and vomiting.
48 2021-03-22 seizure Non-provoked first time seizure
48 2021-03-23 feeling hot, tremor Client received 1st Pfizer Covid Vaccine (Lot # ER8732, Exp 3/24/21) approximately 1545. Client was ... Read more
Client received 1st Pfizer Covid Vaccine (Lot # ER8732, Exp 3/24/21) approximately 1545. Client was sitting in post vaccine waiting area when she alerted EMT she was feeling lightheaded and dizzy. RN joined and began to assess client. Vitals at 1600: blood pressure 126/80 pulse 84, respirations 18. Alert and oriented. No swelling noted. Client denied shortness of breath. Per client no history of allergies or reaction to vaccines in the past. Client asked for water. PHN joined team, client instructed to take small sips of water. Client mentioned she had not ate yet and thought maybe it was related to that. Client informed she would be observed another 15 mins due to current symptoms. 1608 client stated feeling warm, anxious, and still lightheaded. PHN offered client benadryl and client accepted. Per client husband came with her and was going to drive her home. Benadryl 50mg was given orally at 1609. Vitals: blood pressure 144/90, pulse 76, respirations 18. Client informed staff she felt hands were shaky and body was warm. Client alert and oriented, no swelling noted. Vitals at 1616: 140/90, pulse 60, respirations 16. At 1622 client stated feeling better, did not want to wait rest of remaining time. Client was advised to consult primary provider prior to receiving second dose Pfizer. Client also given ER precautions. Husband was waiting in parking lot and was going to drive client home. Client left facility with a steady gait at 1630.
48 2021-03-23 feeling hot Within 10 minutes of receiving the vaccine, my skin broke out in hives, was itchy and hot. I took o... Read more
Within 10 minutes of receiving the vaccine, my skin broke out in hives, was itchy and hot. I took over the counter Benadryl about an hour later. The hives subsided but the itching lasted approximately 24 hours after injection. I called the clinic and spoke to a nurse who in turn recommended my primary physician contact me. My primary physician and I spoke by phone the next day. No office visit was scheduled.
48 2021-03-23 flushing About 25 minutes after 1st dose of Pfizer covid vaccination the patient noted facial itching and flu... Read more
About 25 minutes after 1st dose of Pfizer covid vaccination the patient noted facial itching and flushing and this was similar to previous anaphylaxis she had from allergy immunotherapy. No angioedema, throat swelling, tongue swelling, sob, wheezing, difficulty speaking or swallowing. She was brought to the medical tent and given benadryl 50mg po and observed x 1 hour. Symptoms completely resolved. She was discharged home with her husband.
48 2021-03-23 flushing Patient reported at about 25 minutes after 1st dose of pfizer covid vaccine she began to feel facia... Read more
Patient reported at about 25 minutes after 1st dose of pfizer covid vaccine she began to feel facial itching and flushing, similar to what she felt with previous anaphylaxis due to allergy immunotherapy. She was brought to the medical tent and given 50mg benadryl po and observed x 1 hour. No progression of symtpoms, vitals stable. No angioedema, throat or tongue swelling, difficulty breathing or speaking, sob, or wheezing. Symptoms had completely resolved prior to discharge. She was driven home by her husband.
48 2021-03-23 migraine Day after vaccine: Bad migraine, fever, chills, body aches Day 3: arm swollen/red at injection site... Read more
Day after vaccine: Bad migraine, fever, chills, body aches Day 3: arm swollen/red at injection site and armpit is sore. Day 4: went to the ED due to worsening symptoms from vaccine injection including a rash
48 2021-03-23 night sweats Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over Sweated all night Swollen armpit lym... Read more
Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over Sweated all night Swollen armpit lymph node Headache
48 2021-03-23 pain in extremity Myalgia, Fever, Rash, lymphadenopathy Narrative: Received 1st dose at 0900 on 3/11/21. Noted incr... Read more
Myalgia, Fever, Rash, lymphadenopathy Narrative: Received 1st dose at 0900 on 3/11/21. Noted increased arm pain that evening and fever that night (up to 100F). Developed swelling in armpit and neck and groin lymph node enlargement on opposite side of injection site. Lymph swelling above clavicle persisted through 3/16/21, though improving. Noted fine papular rash as well. Pt has had COVID infection 11/2020 Other Relevant History:
48 2021-03-23 pain in extremity Swollen lymph glands; Headache; Arm Pain; Fever; First dose on 02Feb2021, second dose on 19Feb2021; ... Read more
Swollen lymph glands; Headache; Arm Pain; Fever; First dose on 02Feb2021, second dose on 19Feb2021; First dose on 02Feb2021, second dose on 19Feb2021; This is a spontaneous report from a contactable healthcare professional reported for herself. This 48-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number El9262) on 19Feb2021 at 08:45 AM single dose at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin, sulfa and Pre diabetic. Historical vaccine was 1st dose of BNT162B2 (lot number El3247) for COVID-19 immunisation on 02Feb2021 at 08:00 AM at left arm. Concomitant drugs included semaglutide (OZEMPIC), pravastatin sodium (PRAVASTINE), metformin and losartan potassium (LOSARTIN). On 19Feb2021 at 06:00 PM, the patient experienced headache, arm pain, fever and worst part was the swollen lymph glands. The patient had visible swollen under arm into breast and down side of her arm, almost looks like a half a baseball sticking out of her arm. The patient saw doctor on 22Feb2021 and received treatment. The outcome of the events was resolving.
48 2021-03-23 tingling, numbness, facial paralysis 30 minutes after my vaccine I started to feel tingling and numbness on my face, mouth and nose. The ... Read more
30 minutes after my vaccine I started to feel tingling and numbness on my face, mouth and nose. The bottom part of my face was numb. I was also nauseous and I had a metal taste in my mouth. Today is the 5 day since my vaccine and the numbness is less. I did not have facial droop.
48 2021-03-24 burning sensation Pt reports: "feeling of itchiness across her entire body and 'burning on the inside.'" "Itchiness an... Read more
Pt reports: "feeling of itchiness across her entire body and 'burning on the inside.'" "Itchiness and a tightness in her throat"
48 2021-03-24 burning sensation Injection given at 4 p.m. by 4:03 p.m. my tongue started to tingle and then turned into a burning se... Read more
Injection given at 4 p.m. by 4:03 p.m. my tongue started to tingle and then turned into a burning sensation by 4:10 my tongue had began to adversely swell to twice its size. I inform the nurses and was immediately taken to the ER where they noticed that my tongue was extremely swollen my throat was beginning to swell and that I had raised up bumps and lesions starting to form on the back side of my tongue. ER staff admitted me and began me on a IV steroid treatment accompanied with Pepcid and Benadryl After 2 hours in the ER under close observation my tongue was still swollen and my windpipe was in danger of being closed off so I was transported via ambulance to Hospital and admitted to Intensive Care Unit where they continued to administer steroids and Benadryl. By 2 a.m. my condition had not improved and I was given an EpiPen in my arm. The EpiPen did help but by 6 a.m. my tongue swelling had returned but not as severe. On march 24th The hospital then moved me from the ICU to the cardiac wing to be placed on a heart monitor as they continue to administer steroids, Benadryl, and Pepcid. I was given another Epi Pen by 11 a.m. in the cardiac care unit due to my tongue beginning to severely swell again. As of today, March 25th My tongue continues to swell and they still have me admitted to the hospital as they continue to observe me and continue to administer steroids and Benadryl all via my i.v. port. Today they are going to begin me on an oral Prednisone.
48 2021-03-24 feeling hot I feel itchy all over from head to toe. There is a slight warming sensation and tightness of my skin... Read more
I feel itchy all over from head to toe. There is a slight warming sensation and tightness of my skin. There are no bumps or rash. It feels like a similar reaction I have to penicillin before the hive appear.
48 2021-03-24 migraine The following morning I woke up with severe migraine, fever (99.5), severe body aches, severe fatigu... Read more
The following morning I woke up with severe migraine, fever (99.5), severe body aches, severe fatigue and slightly nauseous. I ran a fever the entire day and felt like I was in a car accident. I could not do my normal activities. I laid in bed all day and had to cancel the appointments I had. Luckily I did not have to work that day. I wouldn't been able to make it. The next day I was fine. I've run a little fever off and on since then (it's been 1 week and 4 days), but I've felt so much better.
48 2021-03-24 pain in extremity Headache, Myalgia, Fever, SkinRash, Diarrhea, "I had a very sore Left arm, considerable pain in the... Read more
Headache, Myalgia, Fever, SkinRash, Diarrhea, "I had a very sore Left arm, considerable pain in the Left Axilla, chills, fatigue, headache, light headedness, body ache and a fever Tuesday night onwards that lasted a few days. Friday evening I developed itching which had increased considerably and Narrative: Employee emails: **************** "Dear Wonderful Members of the COVID Team, Hope that all of you are fabulous as we are at our end and staying healthy and happy. I was asked to reach out to you and notify you regarding my allergic reaction to my second dose of the Pfizer vaccine. I had my first dose on Tuesday, February 16, 2021 in the morning and experienced soreness in the left arm and pain with moving it for a day or two starting Tuesday night. I also had chills Tuesday night, chills, body ache and diarrhea Wednesday night and chills and fever, Sunday evening onwards for a few days. All was good and then I had my second dose on Tuesday, March 9, 2020 in the afternoon. I had a very sore Left arm, considerable pain in the Left Axilla, chills, fatigue, headache, light headedness, body ache and a fever Tuesday night onwards that lasted a few days. Friday evening I developed itching which had increased considerably and I got some hives and a rash Saturday onwards with throat restrictions, left greater than right. Benadryl, Claritin, Zyrtec did not provide any relief and I was unable to have clothes on due to the increased itching. I went to the Urgent Care on Sunday and they put me on Famotidine along with Cetrizine and emollients, and Benadryl at night, to no avail. On Monday I saw my PCP who examined me and started me on 5 mg Prednisone which did not help and after consulting with an Allergist, I was put on a course of 20 mg a day for 2 days, 10 mg a day for 2 days and then 5 mg a day for 2 days. The itching decreased and finally subsided by this past Saturday. The body aches are there (some) but I can handle all of that. The itching was crazy. I know that I will do Great!! Thank You for your kind time and for all you do. Have a great week. Happy Spring!! Kindest Regards, patient" Other Relevant History:
48 2021-03-24 pain in extremity My arm was sore and the rash started. It has been present since 01/07/2021 and it is not going away.... Read more
My arm was sore and the rash started. It has been present since 01/07/2021 and it is not going away. The only thing different is the vaccine. I've had IV antibiotics twice that seems to help so that it's not quiet as bad. It has never gone away.
48 2021-03-24 tingling A few minutes after receiving vaccine patient reported with itchy throat and tingling of neck and fa... Read more
A few minutes after receiving vaccine patient reported with itchy throat and tingling of neck and face. Previous history of anaphylaxis to bee stings. Gave 50mg Benadryl and bottle of water. Patient did not want Epi-pen until absolutely necessary because she said previously it took her down for 2 days. She had us call husband and sister and asked for EMS to be called. Still declined Epi-pen. EMS took her to (hospital).
48 2021-03-24 tremor Injection site pain, injection site swelling, injection site redness, shaking, chills, tiredness, he... Read more
Injection site pain, injection site swelling, injection site redness, shaking, chills, tiredness, headache, muscle pain, joint pain, nausea, feeling unwell, fever of 103.6
48 2021-03-25 burning sensation Rash around the neck area that spread to chest and back of the neck later in the day. Very itchy and... Read more
Rash around the neck area that spread to chest and back of the neck later in the day. Very itchy and have a burning sensation. The lymph node in the left neck area where the rash is, feels swollen.
48 2021-03-25 feeling hot Severe hives over entire body 2 hours after injection, especially bad on face and neck. Felt extrem... Read more
Severe hives over entire body 2 hours after injection, especially bad on face and neck. Felt extremely hot from the inside out. Seen at Urgent Care, given shot of Benedryl and a dose of Prednisone Symptoms continued into the next day and evening, took Benedryl every 4 hours Symptoms improved by 03/26, though not completely gone.
48 2021-03-25 feeling hot Patient received vaccine at 14:15 and was in the observation room when at 14:30 reported feeling diz... Read more
Patient received vaccine at 14:15 and was in the observation room when at 14:30 reported feeling dizzy, warm, hear raising and not feeling right. A team alert was called and at 14:30 healthcare team arrived to provide assistance. Patient's blood pressure was up and was taken by team to medical office for further evaluation.
48 2021-03-25 flushing Facial flushing, slight chest tightness. BPs 155/103 (pulse 90), 98-99% O2 sat; 156/97 (pulse 79), 9... Read more
Facial flushing, slight chest tightness. BPs 155/103 (pulse 90), 98-99% O2 sat; 156/97 (pulse 79), 99% O2 sat.
48 2021-03-25 numbness, tingling Patient woke up in the middle of the night due to her chin quivering and then noticed facial numbnes... Read more
Patient woke up in the middle of the night due to her chin quivering and then noticed facial numbness, specifically the left side of her chin and lip. The left side of her jaw was numb and tingling. When she woke up this morning, she noticed that her arm felt heavy, numb, and somewhat tingly. As of late morning today, her arm is still a little tingly and numb. This sensation goes from the top of her arm to her fingertips, specifically her 4th and 5th fingers. She does not notice any facial paralysis or drooling and she was able to suck out of a straw this morning. She will notify her doctor and seek follow-up care if it does not improve.
48 2021-03-25 muscle spasms Blurring in right eye that comes and goes, constant muscle spasms in stomach
48 2021-03-25 pain in extremity, tingling 40 minutes after receiving the shot my face felt like it was swelling. It felt like my left side of... Read more
40 minutes after receiving the shot my face felt like it was swelling. It felt like my left side of my face swelled first and then 3 minutes later if felt like it generalized to the entire face. (I received the shot on my left side) I also felt some faint tingling in my mouth. Looking in the mirror, I couldn't tell if it was swollen but my sensation of my skin was swollen & tight. After about 10 minutes it felt like it was easing off. A hour later my face felt a little tingly like a Novocain shot had almost worn off. After 3 hours, I felt normal. Then day 2 & 3: a sore arm. Then day 4: muscle aches, fatigue & headache.
48 2021-03-25 pain in extremity I have a headache, fever, chills, exhausted. Now I have covid arm. My arm is itchy, swollen, pain, a... Read more
I have a headache, fever, chills, exhausted. Now I have covid arm. My arm is itchy, swollen, pain, and have slight rash.
48 2021-03-25 pain in extremity Fever >102.4, congestion, sore arm, difficulty breathing, severe asthma, malaise, headache. Minor te... Read more
Fever >102.4, congestion, sore arm, difficulty breathing, severe asthma, malaise, headache. Minor temp started around 10pm, woke up 3:30am with extreme cough and SOB, asthma, wheezing; fever rose throughout day greater than 102, continued shortness of breathe, coughing, congestion, wheezing, sought treatment in Emergency Room
48 2021-03-26 feeling hot, hot flush, pain in extremity, weakness 03/23/2021 - injection given and within 2-3 minutes after injection I had heart palpitations and flu... Read more
03/23/2021 - injection given and within 2-3 minutes after injection I had heart palpitations and flush of heat over my body. After about 3 minutes heartbeat regulated and flush of heat dissipated. About 45 minutes later I got a headache last about 15 minutes. Then came back about an hour later lasting same time before stopping. This occurred again about 3 hours later, same as before. 03/24/2021 - arm was sore and injection site was slightly itchy and hot but stopped by 03/25/2021, no hunger. 03/24/2021 - woke up feeling nauseous and overall crappy feeling (not achy, not in pain). nausea lasted throughout the day, but no vomiting. headache often throughout the day but not lasting more than 10-15 minutes, no hunger. 03/25/2021 - again woke up feeling nauseous lasting off/on thru day, no vomiting, no headache, feeling overall more energetic wanting to eat when nausea went away. 03/26/2021 - woke up NO nausea, not hungry so ate later in afternoon. Within 20 minutes of me eating I became extremely fatigued, dizzy and could barely stand up. I started to feel like I was going to faint and got to a couch and laid down. I started sweating and felt like my body was on fire. My scalp and face were wet with sweat, I felt dizzy and extremely nauseous before I vomited (3) times. After vomiting the dizziness, nausea and weakness dissipated. After about 30 minutes I just felt tired and my chest hurt from the convulsions of vomiting. After about 2 hours I felt better and just tired. 03/27/2021 - woke up no nausea, no headache and slightly fatigued.
48 2021-03-26 muscle spasms, hot flush I had a reaction within the 15 minute observation period. I had a hot flash, increased HR, and muscl... Read more
I had a reaction within the 15 minute observation period. I had a hot flash, increased HR, and muscle spasms near my right ankle. I was examined by the Physician and EMT on site. The following day, I experienced body and head aches. Naproxen and Tylenol
48 2021-03-26 numbness and pain in extremities, breast pain I received Vaccine No. 2 at 5:45 p.m. on 03/19/21. Beginning at around 2:30 a.m. on 03/20/21, sympto... Read more
I received Vaccine No. 2 at 5:45 p.m. on 03/19/21. Beginning at around 2:30 a.m. on 03/20/21, symptoms started to gradually surface that progressed throughout the day, such as: - intense pain at the site of the injection that spread to my underarm and left side of ribcage/breast - chills - low grade fever - aching joints - painful skin surface on my whole body - headache - shortness of breath - neuropathy - nausea - loss of appetite - loss of taste - stuffy nose
48 2021-03-26 pain in extremity headache, sore arm, dizziness, nausea, fatigue
48 2021-03-27 weakness, migraine Via phone call on 3/24/21 - She states that approximately 10 minutes after getting her vaccine she s... Read more
Via phone call on 3/24/21 - She states that approximately 10 minutes after getting her vaccine she started having itching in her throat and an "extreme Migraine". She was given Benadryl. The muscles in her throat seized up and she could not swallow and the itching in her throat became "severe". She was given an Epipen and was sent to Emergency Department via rescue. She states she was treated in the Emergency Department and discharged to home 5 to 6 hours later with prescription for Prednisone which she took for 3 days. In addition to the Prednisone, she took Benadryl for 4 days. She is going to follow up with her Primary Care Physician next week. States since receiving the vaccine she still has no energy and pressure behind her nose - "like someone is pushing or holding pressure behind her nose."
48 2021-03-27 flushing Flushing and sensation that throat was closing
48 2021-03-27 pain in extremity, tenderness March 8th. Almost 0 pain at injection site for first 3 hours then a little soreness Three hours lat... Read more
March 8th. Almost 0 pain at injection site for first 3 hours then a little soreness Three hours later a few minor sx began:- chills on my skin starting at hands, then pain across bottom of rib cage, then stabbing pains throughout torseau and legs-worsened at night time and joined by severe chills-shivering. All next day felt like I had flu-waking up most every hour-level 5-6 headache also developed. March 9th felt like I had the flu most of the day-flushing, then getting chills. still stabbing pains and indigestion-very tender around ribcage (tender to the touch). Took peptobismol tablet. Good 11-12 hour sleep 2nd night. Next morning:
48 2021-03-27 tremor, involuntary muscle movements Severe jerking and shaking intermittently for 18 hours. Also extremely tired for 7 days. Anxiety at... Read more
Severe jerking and shaking intermittently for 18 hours. Also extremely tired for 7 days. Anxiety attacks prevalent still happening.
48 2021-03-28 numbness When dose was injected I got a bruise right after she finished administering shot. She was surprise... Read more
When dose was injected I got a bruise right after she finished administering shot. She was surprised of bruise and mentioned that i shouldn't have bleed but I did. Were injection was administered I had a marble size bump all day yesterday even mid evening I put ice for swelling and pain took Tylenol also. This morning my arm still hurts and my hand continues to get numb feels like if i am not getting enough circulation.
48 2021-03-28 migraine On Saturday, March 27 at about 8:00 p.m. I had a severe migraine headache that caused vomiting. I do... Read more
On Saturday, March 27 at about 8:00 p.m. I had a severe migraine headache that caused vomiting. I don't usually have headaches. The only time I could remember having a similar experience of such a severe headache was the one time in July of 2019 when I had drunk too much water in too short a time span and washed all the sodium from my system. I was treated at the Hospital at that time for that incident, Having had that previous experience, I was concerned for my health and safety having another similar headache on Saturday night. By 11:00 p.m. the pain had intensified and I went to the Hospital for treatment. The doctor ordered a blood panel and a ct scan of my head. All the results came back normal.
48 2021-03-28 pain in extremity, flushing dizziness, confusion, facial flushing, accelerated heartrate, hives and itchiness in throat. Followe... Read more
dizziness, confusion, facial flushing, accelerated heartrate, hives and itchiness in throat. Followed by two days of soreness to arm and redness at injection site.
48 2021-03-28 pain in extremity VACCINE WAS GIVEN ON MY RIGHT ARM WHICH AFTER VACCINE WAS ADMINISTERED I FELT A SORE ARM AND TO THIS... Read more
VACCINE WAS GIVEN ON MY RIGHT ARM WHICH AFTER VACCINE WAS ADMINISTERED I FELT A SORE ARM AND TO THIS DAY I STILL FEEL SORENESS ESPECIALLY IN THE MORNING WHEN I WAKE UP
48 2021-03-28 tingling Throat thickness/swelling occurred about 5 times (feeling occurred off and on for 45 minutes) Tingli... Read more
Throat thickness/swelling occurred about 5 times (feeling occurred off and on for 45 minutes) Tingling on left side of body (feeling lasting about 10 hours)
48 2021-03-29 pain in extremity I had a large lump develop just above the injection site. It was hot to the touch, and there was ar... Read more
I had a large lump develop just above the injection site. It was hot to the touch, and there was arm pain. It's been almost a week since receiving the vaccine and it's not hot, but the lump is still quite sizeable, hard, but doesn't feel hot. Every so often I have pain, and I cannot put pressure on the upper arm.
48 2021-03-30 discomfort With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area... Read more
With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area; With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area; With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area; This is a spontaneous report from a contactable nurse. This 48-year-old female nurse reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EH9899) intramuscularly from 18Dec2020 at 12:00 pm to 18Dec2020 at 12:00 pm at single dose (dose number; 1) on left arm, then second dose, lot number; EL1283 from 07Jan2020 to 07Jan2020 (dose number; 2) at single dose on right arm for covid-19 immunization. Patient was not pregnant at the time of vaccination. Vaccine facility type was reported as hospital. Patient's medical history (If covid prior vaccination, If covid tested post vaccination; no) was not reported. Past drug included allergy; sulfa. Other vaccine in four weeks was reported as no. Concomitant medications (other medications in two weeks) included ESTRADIOL (Estrogen), progesterone and multivits. Nurse reported that on 18Dec2020 at 12:00 pm with both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area. Treatment was not given for the AE. Outcome of event was not recovered.
48 2021-03-30 feeling hot Within 5 minutes of receiving the vaccine, the end of my tongue began to tingle and feel numb. I fel... Read more
Within 5 minutes of receiving the vaccine, the end of my tongue began to tingle and feel numb. I felt some hot sensations down my left leg. Then my throat began to feel itchy and irritated. I could still breathe and swallow so I did not alert the pharmacy staff. I took a Benadryl allergy pill and went home. The tongue and throat irritation continued into the night but seemed to be better the next day. Since then, however, I continue to have tongue and throat irritation on a daily basis. The severity can change but the irritation hasn't gone away. My tongue feels like I licked a bad-tasting stamp. My throat isn't sore, it's more of an internal itch/irritation, like how I imagine it would be to have Poison Ivy in my throat. I take Benadryl daily for run-of-the-mill allergies from pollen, hay fever, etc. It's not having an effect. I feel like I want cold, frozen items to soothe my throat. I have not yet seen my family doctor about this, but I may do so if the symptoms worsen or I can no longer tolerate them -- or I become concerned about getting my second dose scheduled for April 10.
48 2021-03-30 feeling hot Date of start of drug 06Jan2021/ Date of start of drug 29Jan2021; 2nd dose Roof of mouth felt like i... Read more
Date of start of drug 06Jan2021/ Date of start of drug 29Jan2021; 2nd dose Roof of mouth felt like it was swelling; My tongue and lips started tingling; Both ears red and felt very warm; Both ears red and felt very warm; Slight headache; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration in left arm on 29Jan2021 at 09:15 as a single dose for covid-19 immunization. Medical history included Allergies to medications, food, or other products: Penicillin, amoxicillin and codeine. Concomitant medications included esomeprazole magnesium (NEXIUM), ibuprofen (IBUPROFEN) and nature's bounty on unspecified date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). The patient experienced second dose roof of mouth felt like it was swelling, y tongue and lips started tingling and both ears red and felt very warm and slight headache for the second dose on 29 Jan2021 at 09:15 AM. The outcome of the events was recovered on an unspecified 2021. Information on the lot/batch number has been requested.
48 2021-03-30 muscle twitching, pain in extremity, muscle spasms Pfizer First day within 15 minutes. Chest tightness. Throat tightness, jaw pain on left side, naus... Read more
Pfizer First day within 15 minutes. Chest tightness. Throat tightness, jaw pain on left side, nausea and headache, left sore arm and left crampy leg. Pain throughout week. Today I woke up very lightheaded, dizziness and body twitching. Last night took hydroxozine 25 mg. I don't think that caused it.
48 2021-03-30 pain in extremity After 1st Dose (2/26/21, 3:50pm)- Pain in left arm appeared about 8 hours after injected and lasted ... Read more
After 1st Dose (2/26/21, 3:50pm)- Pain in left arm appeared about 8 hours after injected and lasted for about 1-2 days. After 2nd Dose (3/22/21, 3:35pm)- Pain in left arm, fever (100.6 F), chills, headache, nausea, body aches (Severe pain in lower back and hips. Knees and elbows ached too. I assume the aches were associated with the fever b/c this often happens to me with fevers). All of these symptoms started around 3:30am 3/23/21 and lasted through 4-5 pm on 3/23/21. Only treatment was Acetaminophen Extra Strength, 2 pills taken around 2:30 pm on 3/23/21. Symptoms started improving 20 minutes after taking medication. I stayed home from work on 3/23/21, but was able to return to work on 3/24/21. Felt great on 3/24/21. No symptoms.
48 2021-03-30 tingling, feeling of body temperature change complaining of /nausea and dry heaves, hot/cold flashes, tingling to fingers/toes, peri-oral with bo... Read more
complaining of /nausea and dry heaves, hot/cold flashes, tingling to fingers/toes, peri-oral with both doses.
48 2021-03-30 tingling, numbness drive through monitoring area. Nurse practitioner approached the client in her car she was here for ... Read more
drive through monitoring area. Nurse practitioner approached the client in her car she was here for 15 minute post vaccination injection. When I asked her how she was doing, she said she was feeling numbness and tingling in her fingers and seeing white spots in her eyes. She was sitting in the car in the sun for the past five minutes or so I got her a bottle of water and moved car into the shade I asked her if I needed to call the paramedics. We initiated the code green and turned over care to the paramedics. Evaluated by paramedics and released. Patient?s husband drove the patient
48 2021-03-30 tenderness Left armpit and shoulder near the collar bone hurt. Both are tender to touch. The armpit is swoll... Read more
Left armpit and shoulder near the collar bone hurt. Both are tender to touch. The armpit is swollen , looks like an egg shape and hurts from the shoulder to the breaat. Very uncomfortable. Headache, tired, body aches - this is ok.
48 2021-03-31 feeling cold, pain in extremity First Dose: 2-3 hours later -> extremely tired, pain in the left arm for 1.5 days, could not raise a... Read more
First Dose: 2-3 hours later -> extremely tired, pain in the left arm for 1.5 days, could not raise arm 3-4 days later -> eczema (rash, itchy, red, bumpy)on the right leg & right arm. The itching stopped 10 days later after the vaccine, the redness took ~ 7 days to go away after the itching went away. Patient evaluated severity as mild to moderate Second Dose: Pain in the arm again 1.5 days, 25 hours after the vaccine suddenly very tired (took 2 hour nap, was ok after that), felt cold when was taking a nap
48 2021-03-31 numbness Face numbness (left side, same side of vaccine administration), starting 5-7 minutes after injection... Read more
Face numbness (left side, same side of vaccine administration), starting 5-7 minutes after injection. Lasted for about 10 minutes. Mild contraction of periocular muscles (right eye) started about 1 hour after shot and have lasted for at least 48 hours after dose.
48 2021-03-31 muscle spasms Approximately 2 1/2 hours after injection I started experiencing cramping and abdominal pain with na... Read more
Approximately 2 1/2 hours after injection I started experiencing cramping and abdominal pain with nausea quickly following. At about the 3 hour mark I started vomiting (several times) and diarrhea followed. The chills then set in with some general achiness and muscle fatique/soreness, I also felt very tired. I did call my PCP who advised that I stay hydrated, watch for rash, eat a bland dinner and if I was not feeling better in the morning to call back. Today, the day after the injection I have had a sensitive stomach, minor muscle fatigue/soreness but a lot of soreness/pain at the injection site.
48 2021-03-31 unresponsive to stimuli, seizure, flushing Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Systemic: Vomiting-Severe, Additional Details: none
48 2021-04-01 numbness, breast pain, hot flush, pain in extremity The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain beca... Read more
The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain became severe by day 3. Pain spread to my right breast, neck, back, and right scapular area. I have had numbness in my fingers on right side. Today is 16 days. The pain increased every day for about 10 days. Decreases slightly and is now holding. I'm am in terrible pain. I didn't sleep for 6 days when the pain was at is peak and still can barely sleep. It's the worst pain of my life. It feels like my arm is in fire and in a meat grinder. My arm and neck pain worsens when I use my arm or change positions. I am also getting flushed heat feelings on my face intermittently. Since this vaccine I have had allergic reactions to ibuprophen and prednisone which sent me to the ER. Two medications I have received before with no problem. I also felt I was reacting to gargling with listerine which I have used before without issue. I eat eggs regularly and got a small sensation of throat swelling with that too and have not eaten them again. My doctor is having trouble treating me since I am now having so many allergy symptoms to different things. I have been advised by my doctor not to continue with this vaccine or any vaccine in the future. I am still in terrible pain that is limiting me from participating i. my normal life activities. I did not develop any rashes or obvious swelling at the injection site. Twenty minutes after receiving the shot I did get a bit flush feeling and some redness in my face and my ears felt hot and then cold. That resolved within about 45 minutes.
48 2021-04-01 numbness, pain in extremity Follow up: Patient stated she was experiencing sharp pain and numbness in left arm after the vaccine... Read more
Follow up: Patient stated she was experiencing sharp pain and numbness in left arm after the vaccine. Patient took vaccine on Monday 3/30/21 and on Tuesday morning right when she woke up pain increased. Thursday 4/1/21 patient is now experiencing swollen glands under left arm (armpit). Patient took ibuprofen 800mg on Wed 3/31/21 around 9pm, also stated that she experienced a slight headache during the day that subsided after taking excedrin. Recommended for her to take tylenol to help with the arm pain. Patient is also waiting for an appt to see her PCP.
48 2021-04-01 muscle spasms On 3/31/21 patient was observed for 15 minutes following vaccination and reported no change to healt... Read more
On 3/31/21 patient was observed for 15 minutes following vaccination and reported no change to health status, so was cleared to leave the clinic area. Patient called the next day (4/1/21) to report that approximately 40 minutes following her vaccination, while driving home, she experienced sudden shortness of breath, muscle spasms, and increased heart rate. Patient reports that she pulled her car over to the side of the road, and then "blacked out". Pt does not know how long she was "out", but upon waking she vomited and called a family member for a ride home. Patient reports that when she got home, she slept for 14 hours. Woke up the next day (4/1/21) and felt sore and exhausted. Vomited a few more times throughout the day, and was on the toilet and she "saw spots" and "blacked out" again. Patient say she did not fall over or collapse. Family member observed this "black out" to last about 30 seconds. As of 4pm that day, more than 24 hours post-vaccination, she was still feeling unwell and not able to keep food down. Patient denies hives, itching, fever, congestion, swollen lips/face. Patient was advised to drink water or electrolyte-drink, rest, and call 911 or her PCP if she experienced another episode of SOB, "black out" period, prolonged vomiting, or new symptoms. Patient agreed to suggested course. Patient has no health insurance, doesn't want to come to a medical clinic for evaluation.
48 2021-04-01 numbness and pain in extremities brachial neuropathy; This is a spontaneous report from a contactable consumer. A 48-years-old femal... Read more
brachial neuropathy; This is a spontaneous report from a contactable consumer. A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 16:00 (Batch/Lot Number: Pfizeren6206) as single dose for covid-19 immunisation (age at vaccination: 48 years) . Medical history included asthma, drug hypersensitivity (allergy to Penicillin). Concomitant medications included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient experienced brachial neuropathy on 12Mar2021 with outcome of not recovered. The reported event was considered an Important Medical Event. (IME). Course of the event: Initial pain subsided in 3 days, then returned with right shoulder joint pain, burning sensation in right side of neck, limited mobility in shoulder joint and severe pain. Dr. Diagnosed as brachial neuropathy. Its 2 weeks now, and still in severe pain. The patient is being treated with Pain meds No follow-up attempts are possible. No further information is expected.
48 2021-04-01 pain in extremity Sore arm, tiredness, nausea, diarrhea, loss of appetite
48 2021-04-01 pain in extremity Very sore arm, general feeling of ?not being myself? for 48 hours
48 2021-04-01 pain in extremity I am post menopausal and approximately 5 weeks after having my second covid vaccination, I had vagin... Read more
I am post menopausal and approximately 5 weeks after having my second covid vaccination, I had vaginal bleeding that lasted about a week. I had had no spotting or breakthrough bleeding since my last peroid in September 2019. I had no other unusal side effects. I experienced the expected fatigue, sore arm and axillary lymph node swelling (12 days post vaccination).
48 2021-04-01 seizure, pain in extremity, tremor Seizure that lasted about 10-15 minutes the next day; Headache; throwing up; arm tremors; not feelin... Read more
Seizure that lasted about 10-15 minutes the next day; Headache; throwing up; arm tremors; not feeling well; sore arm; This is a spontaneous report from a patient. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration, administered in Arm Left first dose on 16Mar2021 09:30 at single dose for COVID-19 immunization. The patient's medical history included Epilepsy. The patient was not pregnant at time of vaccination. The patient's concomitant medications included oral levetiracetam (KEPPRA) for epilepsy at 4000 mg, daily, valproate semisodium (DEPAKOTE) for epilepsy at 500 mg, daily, and valproate semisodium (DIVALPROEX) for epilepsy at 500 mg. The patient stated that she got the vaccine on 16Mar2021. The patient had a a seizure that lasted about 10-15 minutes the next day on 17Mar2021 at maybe 11pm-1130pm. The patient was out with someone and he took her back to her house and she wasn't feeling like, not normal, and he told her she needed to go to the hospital and it took her awhile as she doesn't realize she had a seizure and it sometimes takes a while to convince her she did. States sometimes with seizures you don't remember. The patient was advised to go to the ER to get checked out and he was really worried. States immediately after the seizure she threw up and was not feeling well at all. States she was not admitted to the hospital. States they did a Ct scan of her head and she had bit her tongue a little bit, which is normal with seizures. States she is improved but she still has the medical condition of epilepsy. The patient stated that after she drove home she noticed when she stretched her arm out she was still having tremors and these for lasted about an hour and then she went to sleep. Caller clarifies that after the hospital she went home and went to sleep. States she had been given Ativan at the hospital to ward off additional seizures and that makes you very tired. The patient also had headaches and still gets them, states they are getting less and less frequent. States the headaches started that same evening, that it was weird she had gone out to dinner and was talking with her friend and she thought I have a headache and he is normally fun and she was not feeling so good. Relays that she thought maybe it was a problem with the food she ate, but states they ordered the same meal and she in confident it is not the food as he did not have any troubles. The patient hasn't had a seizure since age 14 and had she known the vaccine would likely cause one she would not have taken it. States she will not take the 2nd one. She said that this was ridiculous. States her arm was sore like from the flu shot or a little worse, but not a big deal. . States her main concern is the seizure. States she is a CPA and it is her busy season for tax returns and saying her arm being sore is eh maybe she wasn't waving it around as much as normal, she is like a praying mantis at her computer typing away. States the soreness started by the end of the work day or that afternoon. States it was no big deal and the next day she did work around the house and was using that arm more and then working from home that day thank God and it was St. Patrick's day and she went out to dinner. States she only noticed the arm soreness/sore arm 16Mar2021 and by the morning of 17Mar2021 she didn't notice it anymore. States she wasn't told she was at risk for a seizure and that would have been helpful as if she had known there was a chance of a seizure she would, like any medication, if there is a chance of seizures she doesn't take it. The outcome of the event Seizure was not recovered. The outcome of the event headache was recovering. The outcome of the event Pain in extremity was recovered on 16Mar2021. The outcome of the remaining events was unknown. Information about the lot/batch number has been requested.
48 2021-04-01 tenderness 1st vaccine: pain to immediate area that lasted approx 4 days; headache. 2nd vaccine: severe headach... Read more
1st vaccine: pain to immediate area that lasted approx 4 days; headache. 2nd vaccine: severe headache within a couple of hours, chills all night (about 14 hours after vaccination); pain to area (not as bad as 1st time); golf size protrusion next to armpit, swelling under arm pit, pain to armpit area and sensitivity; tired first 2 days and then exhausted day 5 and 6; rash next to armpit of other arm.
48 2021-04-02 feeling hot On my drive home, I began to feel queasy, A few minutes later, I felt a rush of heat on my back, co... Read more
On my drive home, I began to feel queasy, A few minutes later, I felt a rush of heat on my back, concentrated on my right side, but traveled out across my back. It lasted only a few seconds. My skin was not sweaty, but I felt like I was really sweating on my back and forehead. About 3 minutes later, I vomited. I was sipping water on my drive home. When I got home, I ate food though I still felt a bit nauseous. About an hour later, my stomach got more upset , I had a loose bowel movement, but no more vomiting. Within 3 hours, I was feeling fine. I do NOT have a history of panic attacks or an anxiety disorder.
48 2021-04-02 numbness Patient complained of numbness in her leg 25 minutes after vaccination. Patient has dealt with sciat... Read more
Patient complained of numbness in her leg 25 minutes after vaccination. Patient has dealt with sciatica in that leg before.
48 2021-04-02 migraine with in 12 hrs i awoke to throwing up and dry heaving for two days migraine that last all6 days ,i b... Read more
with in 12 hrs i awoke to throwing up and dry heaving for two days migraine that last all6 days ,i broke out with a rash that resembled a a bad sunburn, that extended from elbow all the way to my scalp, dizziness,and i ached all over had low grade fever and chills that lasted 3 days my mouth went very dry
48 2021-04-02 pain in extremity By midnight I was experiencing minor arm soreness like I did with first dose. By early next morning ... Read more
By midnight I was experiencing minor arm soreness like I did with first dose. By early next morning shot location was red, swollen, raised somewhat, hot to the touch, and had spread up my arm to armpit/lymphnodes, very painful. Felt a sensation as though the allergic reaction was spreading across my chest - but no visible signs of that. Im almost 3 days out and still have swelling from injection site underarm. Separate from this, I had a constant headache that started a couple of hours after shot and is finally gone today. I had mild fever the first two days but that seems to have subsided. Was nauseous the first day. Woke up with terrible stomachache this morning followed by diarrhea. All over body aches and pains - were at their worst the first two days, today still there but less so.
48 2021-04-03 weakness Weakness, fogginess in head - not thinking clearly, chills even a week later, no energy, exhaustion,... Read more
Weakness, fogginess in head - not thinking clearly, chills even a week later, no energy, exhaustion, funny feeling on left side of face, loss of appetite, general feeling of unwell and not feeling like myself.
48 2021-04-03 feeling hot, cold sweat On, 4/2/2021, at 6:30 pm, I went from feeling like myself to cold, clammy, hot , sweaty, very nau... Read more
On, 4/2/2021, at 6:30 pm, I went from feeling like myself to cold, clammy, hot , sweaty, very nauseous and dizzy. I laid down and slept from 7:00 pm - 10pm. Woke up for an hour then slept from 11:00 pm -10:30 am. I felt great on 4/3/2021. On 4/4/2021, I had a soft stool, at 9:30 am,. At 10:30, I had diarrhea with abdominal cramps that lasted 3 hours.
48 2021-04-03 hot flush, throat numbness Throat became full on both sides & back of throat numb. Began 3 minutes after injection & lasted for... Read more
Throat became full on both sides & back of throat numb. Began 3 minutes after injection & lasted for 1 hour. Heart racing, hot flash which continued to last for 30 minutes
48 2021-04-03 numbness Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / He... Read more
Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Vomiting-Medium, Additional Details: Patients states she cannot lift arm more than 45 degrees, difficulty breathing secondary to chest tightness.
48 2021-04-03 pain in extremity Arm pain on first day Tendons stiffness on one arm and both wrists on second night 4th day - Early m... Read more
Arm pain on first day Tendons stiffness on one arm and both wrists on second night 4th day - Early menstrual period ( 2 weeks early): sudden bright red bleeding without usual signs of menstrual periods (no cramps, very unusual), and large clots in the bleeding Nausea, 2nd day
48 2021-04-03 pain in extremity Onset of symptoms was 24 hrs after vaccine. First symptoms were fatigue, abdominal discomfort, loss... Read more
Onset of symptoms was 24 hrs after vaccine. First symptoms were fatigue, abdominal discomfort, loss of appetite, mild dizziness, swollen injection site, arm soreness. Starting 48 hours after the vaccine: jaundice symptoms, including: itchiness on the feet and palms, large patchy bruises on the legs, clay-colored stools, extreme fatigue, yellowing of the eyes, dark-colored urine. Later, small, round, skin lesions emerged and spread , starting around March 11, 2021. By the 23, red, itchy, patches had expanded over the chest, abdomen and groin areas.
48 2021-04-03 pain in extremity 1st shot just had sore arm the next day for a few hours. 2nd shot side effects 6hrs after: sore arm,... Read more
1st shot just had sore arm the next day for a few hours. 2nd shot side effects 6hrs after: sore arm, muscle aches entire body, extreme fatigue, body feels really heavy (like being pulled down), chest feels thick (like full of cotton), headache, alot of nausea, taste and smell are muted (still have both but not as intense as normal). My doctor thinks I was an undiagnosed covid case, early on in the pandemic (had been exposed unknowingly to someone who had traveled 3mths overseas at the pandemic outbreak, the tests they ran came up unknown but all my symptoms were what would turn out to be covid symptoms including complete loss of taste and smell.
48 2021-04-04 difficulty speaking Hoarseness
48 2021-04-04 migraine Day 1 - minor headache, nausea, exhaustion Day 2 - exhaustion, migraine Day 3 - latissimus dorsi pai... Read more
Day 1 - minor headache, nausea, exhaustion Day 2 - exhaustion, migraine Day 3 - latissimus dorsi pain on same side as injection (L)
48 2021-04-04 nerve pain, numbness Nerve, muscle and joint pain on my entire body left side only. Numbness, weakness in left hand.
48 2021-04-04 pain in extremity, breast pain After 1st: swollen node in throat, breast pain on right side After 2nd: (shot at 4:30pm) sore arm, ... Read more
After 1st: swollen node in throat, breast pain on right side After 2nd: (shot at 4:30pm) sore arm, then next morning, aches thorughout body - muscles and joints all day. exhuastion. Chills started around 2 pm 4/2; then fever began about 30 minutes later lasting into early morning hours of 4/3 and spiking to 105.5 - with Motrin and Tylonal every 3 hours it held b/t 102.8 - 103.8. 4/3, no fever but hurt, tired, foggy brain. 4/4, muscle aches, not feeling right, headache 4/5 (today) headache, body "off" - don't feel right - body feels slow and heavy, bad headache still
48 2021-04-05 tingling patient reported tingling in throat and hands 10 minutes after vaccine administration- physician not... Read more
patient reported tingling in throat and hands 10 minutes after vaccine administration- physician notified -administered diphenhydramine 25 mg po and observed addition 30 minutes until symptoms resolved
48 2021-04-05 tingling Within ten minutes of the shot in the left arm, I experienced paresthesia (numbness, burning, and ti... Read more
Within ten minutes of the shot in the left arm, I experienced paresthesia (numbness, burning, and tingling) of Cranial Nerve VII as well as a feeling as if a cotton ball had been inserted toward the front of my ear (no hearing loss or pain, just an odd feeling of fullness). As this was not a reaction I had been told to watch for, I thought I must be imagining it, and did not report to onsite personnel. When it was still happening fifteen hours later, I called the OHSU COVID line for advice.
48 2021-04-06 feeling hot Approximately 40 minutes after administration of the medication, general statement to another staff... Read more
Approximately 40 minutes after administration of the medication, general statement to another staff member that she was feeling itchy. This other staff member reported it to me. I assessed staff member and her complaints were that her throat was feeling tight and that her arms were itchy and she felt anxious and hot. No rash noted. Staff member was given a fan to cool off and she kept insisting that she was fine. Benadryl 50mg was given po at her request at approximately 50 minutes after vaccine. About 75 minutes later, she states she feels like it may be getting worse. I phoned NP and called EMS. Staff member had her own Epi pen (states she asked for it when she had a reaction to Amoxicillin a while back). While on the phone with EMS dispatcher, and staff member was answering questions, it was decided to have staff member to go ahead and do her Epi pen auto inject. It was injected by herself in her Right outer thigh. Almost immediately staff member states that she felt better. EMS arrived a short time later, approximately 12 minutes, staff member states felt better, with no further feelings of her throat being tight or itchy. BP was elevated at 170/90 as per EMS. Staff member refused to go to ER to be evaluated as she states "I am much better now." Staff member continued to stay at work for another 30 mins and allowed a fellow staff member to follow her home. I also checked on her at 745pm via phone and she states that she is just sleepy.
48 2021-04-06 flushing Five min after vaccination pt felt tingling in tongue, lips, mouth, coughing, flushed skin . Os sat ... Read more
Five min after vaccination pt felt tingling in tongue, lips, mouth, coughing, flushed skin . Os sat was 99% room air, pulse 67, lungs clear bilaterally to auscultation. Sx fully resolved at 3:55 pm without use of medication.
48 2021-04-06 flushing flushed, hot, itchy Benadryl 50mg IM given in car observed in medical tent for 30-60 minutes patient... Read more
flushed, hot, itchy Benadryl 50mg IM given in car observed in medical tent for 30-60 minutes patient left in POV feeling much better
48 2021-04-06 migraine, pain in extremity Received vaccine at 3PM; at 11PM started to have fever and mild arm soreness, by midnight had migrai... Read more
Received vaccine at 3PM; at 11PM started to have fever and mild arm soreness, by midnight had migraine. In the morning at 6AM, had full arm pain at injection site (muscle tight and sore) and fever and migraine continued. At 8 AM, fever was gone, migraine mild, but became puffy (inflamed) in my face and gut. At 1PM my tooth #23 was very sore (just had a filling replaced on that tooth four weeks ago) and entire jaw on right side as very sore.
48 2021-04-06 migraine For the first week I had moderate or mild reactions the second week ( I am currently on day 10) my r... Read more
For the first week I had moderate or mild reactions the second week ( I am currently on day 10) my reactions have gotten much worse. Day 7 night was met by extreme fatigue not being able to get out of bed and extreme migraine headache. Day 8 extreme fatigue and couldn?t get out of bed. Day 9 extreme abdominal pain. Now on day 10 extreme diarrhea. This is complete crap. No one said that reactions would last a week or more. You all lied to us to get us to take this shot without knowing if it was safe for everyone.
48 2021-04-06 tingling, numbness SOB, numbness and tingling in lower extremities. Confused, did not know where she was . BP 170/100 ... Read more
SOB, numbness and tingling in lower extremities. Confused, did not know where she was . BP 170/100 HR 135 EKG- PVCs. transported to Hospital
48 2021-04-07 feeling of body temperature change Systemic ache and headache; feeling hot and cold but no fever. Managed using acetaminophen and ibupr... Read more
Systemic ache and headache; feeling hot and cold but no fever. Managed using acetaminophen and ibuprofen. Approx. 35 hours duration
48 2021-04-07 pain in extremity Eve of vaccine, only arm soreness, shoulder and neck stiffness. Day after vaccine on 4/7, more sever... Read more
Eve of vaccine, only arm soreness, shoulder and neck stiffness. Day after vaccine on 4/7, more severe muscle soreness/stiffness, headache, heartburn and a raised, red, not really itchy rash appeared around 7pm covering my entire abdomen. Today, 4/8/21, the rash was pinpoint red on my abdomen but now large, raised and patchy on my chest. I mostly just wanted to report the rash since it was so delayed and I wasn't expecting this. The other symptoms I was expecting.
48 2021-04-07 seizure Regular adverse events - bedridden from Friday night until Sunday afternoon - chills, joint pain, mu... Read more
Regular adverse events - bedridden from Friday night until Sunday afternoon - chills, joint pain, muscle weakness, chest pain, lung tightness, shortness of breath, hip trying to pop out of socket due to joint weakness - all experienced with covid in January 2021;Irregular adverse event: two seizures at approx. 11:30 p.m. uncontrollable body stiff, shaking, eyes roll back in head, moaning
48 2021-04-08 feeling hot Within 7 minutes she started feeling a very warm sensation in her neck moving upwards which slowed d... Read more
Within 7 minutes she started feeling a very warm sensation in her neck moving upwards which slowed down her breathing. She checked her pulse and it was low. She experienced blurry vision and extreme fatigue for 3 days.
48 2021-04-08 pain in extremity Fever, body aches, nausea, chills, arm pain, headache dizziness, lethargy
48 2021-04-08 tremor, weakness In addition to injection site soreness, I started experiencing significant malaise 20 hours after th... Read more
In addition to injection site soreness, I started experiencing significant malaise 20 hours after the shot, at 22 hours after the shot temperature was 100.8 F with shaking chills and body aches, at 24 hours after the shot temperature was 102.4 F with shaking chills and body aches. Treated fever with Tylenol. Temperature was reduced to 101.3 and stayed around there the rest of the day with occasional chills as Tylenol wore off. Lymph node in left arm pit became swollen by 36 hours after the shot but fever, body aches dissipated by 48 hours after the shot. After this there were no further fever or aches and felt substantially better except for a little weakness. By 72 hours after the shot only minor muscle soreness at the injection site and lesser swelling of the lymph node in the left arm pit with no other symptoms.
48 2021-04-09 feeling cold Approximately 12 hours (around 2am) after the 2nd dose, my upper body felt very achy, especially my ... Read more
Approximately 12 hours (around 2am) after the 2nd dose, my upper body felt very achy, especially my arms and "core" body. I also felt cold, and had a headache. I did not sleep well; however, I was too tired and muscles too sore to get up in the morning. I slept until around 1pm the next day . At approximately 1pm the next day (about 23 hours after the 2nd dose). I felt well enough to get out of bed and move around, but still very tired and went to bed early in the evening. After the second night of sleep, I woke-up refreshed the next morning and did not have any more symptoms.
48 2021-04-09 feeling hot tongue tingling, bilateral sides of mouth, back of tongue and back of throat. Chest warmth and tigh... Read more
tongue tingling, bilateral sides of mouth, back of tongue and back of throat. Chest warmth and tightness
48 2021-04-09 feeling hot Patient w/ history of anxiety and bipolar, felt warm and anxious immediately after vaccine. BP initi... Read more
Patient w/ history of anxiety and bipolar, felt warm and anxious immediately after vaccine. BP initially 170/100 HR98, decreased to 152/105, HR 86.
48 2021-04-09 feeling hot patient sitting in the chair and 5 minutes after vaccine patient stated she was experiencing a warm ... Read more
patient sitting in the chair and 5 minutes after vaccine patient stated she was experiencing a warm feeling on the right side of her neck running from the claivicle area to the side of her ear and a tightening feeling. vitals were taken 3:33 b/p 110/65 p 67 r18 sat 99% 2nd at 3:40 b/p 111/66 p 68 r 18 sat 99% 3rd at 3:50nb/p 112/76 p 94 r 18 sat 98% patient stated she was feeling much better patient was educated and encouraged to go to the nearest ER if any other side effects should occur patient was wheeled to the main entrance with husband to be released to go home safely.
48 2021-04-09 feeling hot patient stated after receiving the vaccine 5 minutes later patient start feeling a warm and tighteni... Read more
patient stated after receiving the vaccine 5 minutes later patient start feeling a warm and tightening feeling in the neck on the right side of the neck from the ear to the clavicle patient vitals were as follows 3:33p b/p 110/65 p 67 r 18 sat 99% 3:40p b/p 111/66 p 68 r 18 sat 99% 3:50 b/p 112/76 p 94 r 18 sat 98% patient later stated she was feeling much better patient was rolled to the main entrance patient was educated and encouraged to reach out to the nearest ER if any problems should occur again.
48 2021-04-09 fibromyalgia Immune Response to the Vaccine. Toe was infected the following day for a week and a half. To return... Read more
Immune Response to the Vaccine. Toe was infected the following day for a week and a half. To return to normal right after 10 days. The left Shoulder hurt and spread throughout the body. Then she experiences Fibromyalgia for 5 days after the Vaccine was administered (21-26MAR21).
48 2021-04-09 numbness Patient vaccinated at 9:29 a.m. and at 9:40 patient reported feeling facial numbness and arm numbnes... Read more
Patient vaccinated at 9:29 a.m. and at 9:40 patient reported feeling facial numbness and arm numbness and swelling in left side and was seen by medical team Patients vitals were stable but the numbness and swelling sensation begun radiating to the right side of face and tongue Patient transferred via ambulance to hospital
48 2021-04-09 migraine Body aches that lasted 24 hours. Daily migraines since 2nd vaccine that require prescription medica... Read more
Body aches that lasted 24 hours. Daily migraines since 2nd vaccine that require prescription medication.
48 2021-04-09 limb paralysis, impaired body coordination 3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes h... Read more
3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes headache and photophobia, 12 hours worsening weakness moving into arms, following day diarrhea, blurred vision, by the 2nd day constipation dysuria, worsening ataxia by day 3, 1 week after unable to move R leg, admitted to hospital 4/1 and discharged next day. Readmitted 4/6 unable to move arms and move bowels/urine.
48 2021-04-09 pain in extremity Headache and arm soreness first day. neck issues day 2. very stiff and sore.
48 2021-04-09 pain in extremity left arm pain; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old n... Read more
left arm pain; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 13:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no prior COVID vaccination. The patient had not tested for COVID post vaccination. No known allergies. The patient experienced left arm pain on 05Feb2021 21:00. The patient did not receive any treatment for AE. Outcome of the event was recovered in Feb2021. Information on the lot/batch number has been requested.
48 2021-04-10 numbness, tingling Fever/body aches and inability to sleep the first night (Wednesday into Thursday) , slight fever (99... Read more
Fever/body aches and inability to sleep the first night (Wednesday into Thursday) , slight fever (99.7) with injection site pain all day on Thursday treated with Tylenol. Severe headache Friday night (around 1:30am.). Headache was gone by morning. Numbness and tingling in my left hand, face and injection site throughout Saturday am. I thought I was having a stroke. Severe Chest pains at 1:30am (Sunday early morning) with nausea and slight fever(99.7). I thought I was having a heart attack. Almost went to the ER but vitals were within normal range when take at home. Ended up taking famotidine and Tylenol and feel fairly normal today (Sunday).
48 2021-04-10 pain in extremity Very sore left arm. Had trouble moving the left arm. Treated with Tylenol, which improved, but did n... Read more
Very sore left arm. Had trouble moving the left arm. Treated with Tylenol, which improved, but did not eradicate, symptoms.
48 2021-04-11 bell's palsy, face paralysis Earache in right ear began on 04/08/21, by 04/11/21 I experienced some loss of muscle control on the... Read more
Earache in right ear began on 04/08/21, by 04/11/21 I experienced some loss of muscle control on the right side of my face (eye, cheek, mouth). I was diagnosed with Bells Palsy. Blood test for Lyme Disease was negative
48 2021-04-11 cold sweat Vaccine administered at 9:30am. At 9:36am patient reported lightheadedness, dizziness, and feeling c... Read more
Vaccine administered at 9:30am. At 9:36am patient reported lightheadedness, dizziness, and feeling clammy. HR 50, RR 17, BP 100/70, O2 100%. Phone call to regional medical director, instructed to give patient food and water and monitor for 30 minutes. At 10:05am patient stated she was feeling well. HR 88, RR 15, BP 110/80, O2 98% at 10:05am. Patient left via personal vehicle with spouse driving.
48 2021-04-11 pain in extremity Sore arm was a given. But I also had runny nose, sneezing, headache and some dizziness.
48 2021-04-11 tingling, numbness 5 hours after injection face and mouth felt numb and tingly. Throat felt like closing up. Took Zyrt... Read more
5 hours after injection face and mouth felt numb and tingly. Throat felt like closing up. Took Zyrtec at 7pm. Following morning after I ate a protein bar my tongue, mouth and throat felt like burning tingly sensation. Called nurse. Instructed to take Benadryl. If symptoms do not improve by 48 hours after vaccine I am to call back. I also notified store and left a voicemail on VAERS hotline
48 2021-04-12 weakness weakness, nausea ,tiredness body aches, sore throat coughing temp 99
48 2021-04-12 breast pain Axillary node swelling under vaccinated arm. It has been one month and I still have swelling and pa... Read more
Axillary node swelling under vaccinated arm. It has been one month and I still have swelling and pain under my arm, on the side of my left breast and in my chest. I have radiating pain up my shoulder where I was vaccinated and into my neck and jaw.
48 2021-04-12 facial paralysis Person received #2 dose Pfizer COVID-19 vaccination January 11, 2021. Approximately March 15, 2021 ... Read more
Person received #2 dose Pfizer COVID-19 vaccination January 11, 2021. Approximately March 15, 2021 experienced eye twitching on occasion. Approximately two weeks later she experienced ear pain. She went to Urgent care and seen by the attending physician. It was later, at a meeting with a colleague that it was noticed that her lip was drooping. She contacted a primary care physician who ordered an MRI stat to R/O stroke. MRI performed on 4/9/21 and resulted negative. She contacted her PCP who has scheduled an appointment for her to be seen this Friday 4/16/21. He has in the meantime ordered steriods for her to take based on her reported symptoms and unconfirmed diagnosis of Bells Palsey.
48 2021-04-12 feeling hot THU Day 1. First Shot: About 20 minutes after the injection, I felt like I had received a muscle rel... Read more
THU Day 1. First Shot: About 20 minutes after the injection, I felt like I had received a muscle relaxer. Instant tired. Went to sleep. FRI Day 2. Injection site pain 7/10. Arm mobility severely limited. General muscle and joint aches 6/10 pain. No fever, but felt hot. Still feel hot, with no fever, on Tue Day 6 (which is today). Fatigue 7/10. Persistent feeling of hunger for about 3 days, no matter how much I eat. SAT/SUN/MON. Regained full use of my left arm. Still feel exhausted 5/10. Head, neck and shoulder pains 8/10. Still feel like I have a fever, but no fever. Persistent runny nose for four days and sore throat 3/10 pain. The oddest thing is that I have an occasional ringing in my ears. Mostly my right ear. A constant static-hissing sound, sometimes a full ringing that fades back to a static-hissing. Very odd. TUE Day 6. Feel hot in the head, no fever. Hearing hissing-static/ringing sound on and off. Runny nose, sore throat. Just wanted to share so you can collect more data.
48 2021-04-12 flushing Approximately 35 minutes after the vaccination the patient developed flushing, redness on arms, neck... Read more
Approximately 35 minutes after the vaccination the patient developed flushing, redness on arms, neck, and face with itching.
48 2021-04-12 flushing Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generaliz... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Flushed / Sweating-Mild
48 2021-04-12 hot flush, night sweats Excruciating headache, bloody nose - then headache started to lift - headaches continue since vaccin... Read more
Excruciating headache, bloody nose - then headache started to lift - headaches continue since vaccine 2 weeks ago. Hot flashes / night sweats since vaccine. Extremely heavy period that came early.
48 2021-04-12 pain in extremity, numbness Patient developed right arm pain that developed into right forearm numbness and weakness of the righ... Read more
Patient developed right arm pain that developed into right forearm numbness and weakness of the right hand. she reports the numbness and tingling and weakness of the right hand has persisted.
48 2021-04-12 pain in extremity, tremor About 2 hours after the 2nd shot, my arm was extremely painful all the way down to my wrist. About 1... Read more
About 2 hours after the 2nd shot, my arm was extremely painful all the way down to my wrist. About 10:30 pm last night, I woke up and realized that I was shaking uncontrollably, even violent at times, for the next 1 1/2 hours and then it suddenly stopped. But then 20 minutes later I started shaking uncontrollably again for several hours. It is currently 8:30 am the next morning and I am still noticing some shaking, just not as violent as before.
48 2021-04-12 pain in extremity Fever~100.5 for 24 hours Nausea ~ 72 hours Discolored stool~ 24 hours (green) Significant body aches... Read more
Fever~100.5 for 24 hours Nausea ~ 72 hours Discolored stool~ 24 hours (green) Significant body aches ~24 hours Enlarged left lymph node under left arm with radiating pain~3 days/72 hours
48 2021-04-12 tingling, pain in extremity, feeling hot Dose 1 Arm pain tiredness. 2-3 days later diarrhea Dose 2 Arm pain tiredness. Next day tired body a... Read more
Dose 1 Arm pain tiredness. 2-3 days later diarrhea Dose 2 Arm pain tiredness. Next day tired body aches. Like pins were poking me in different places. Mostly left side. An icy hot sort of feeling would also pop up in different places. Everywhere. Left side neck pain and jaw pain. 2-3 days later diarrhea.
48 2021-04-12 tingling Tingling in legs and feet that lasted about 24 hours post injection
48 2021-04-12 tenderness Swelling in the armpit day 2 post vaccine Day 4: swollen lymph gland left neck. mild tenderness. 1x... Read more
Swelling in the armpit day 2 post vaccine Day 4: swollen lymph gland left neck. mild tenderness. 1x1 cm
48 2021-04-13 weakness headache and weakness, took nothing for it, symptoms have decreased
48 2021-04-13 hot flush Soreness at injection site-started 4 hours after injection, lasted about 36 hours Fatigue- started n... Read more
Soreness at injection site-started 4 hours after injection, lasted about 36 hours Fatigue- started next morning 9am. Lasted off and on about 48 hours Hot flashes- started about 6 hours after injection. Totally random times lasting 5 minutes to 30 minutes each without fever over the next 84-96 hours Headache- 48 hours after injection. Off and on over next 48 hours Irritability- started 30 minutes after injection. Has been 105.5 hours and is still occurring.
48 2021-04-13 migraine Migraine
48 2021-04-13 tingling 1050 - Light headed, tight throat, tingle fingers, rush neck to ears, BP 139/81 pulse 101 1055 - tig... Read more
1050 - Light headed, tight throat, tingle fingers, rush neck to ears, BP 139/81 pulse 101 1055 - tight chest, difficult to breath, unable to swallow. Benadryl liq 25/mg given Patient transferred to Emergency Department for evaluation.
48 2021-04-13 tingling On 4/12/2021 patient started having new onset headache, right sided facial tingling, bilateral hand ... Read more
On 4/12/2021 patient started having new onset headache, right sided facial tingling, bilateral hand tingling
48 2021-04-13 tingling 36 hours after vaccine, bilateral paresthesia of arms legs, hands, feet and tip of tongue.
48 2021-04-14 weakness, numbness About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both... Read more
About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both arms, hands and right legs. I first noticed my symptoms as I had been walking for about 2 miles and I felt my right leg becoming weak all of a sudden and I felt dizzy, dizzy as in feeling like collapsing. I did not collapse but felt o the verge of it all the way back to my house. I had to concentrate real hard to walk back to my neighborhood without passing out. It happens on two other walks. I have now stopped all walks since week 3 of my vaccine. Into my second dosis and it is worse. Other symptoms include feeling lethargic as if I had a serious disease tired after just washing a plate kind of fatigue. I can feel my heart beat very strongly in my right breast, in my throat or in the back of torso by the end of the day. My arms are always numb but with different intensity, especially if I walk around a bit, with my arms facing down. I am feeling extremely dizzy as unstable and having to concentrate to walk very straight if I am out side. My legs feel like they are not reliable (never have had that feeling at my age). It is more than feeling like a zombie, it is feeling too weak to do anything and my head is sometimes spinning. The numbness can be painful as a sudden thrust in an arm ( this does not last more than a few seconds). It has now been going on since week 3 of my first dosis and today is day 7 of my second dosis! I had 0 symptoms on the first 2 weeks of my vaccine, dosis one. Now, I don't see any progress, rather a slight worsening of all the symptoms above. It is freakish not knowing what I have, of course. One can imagine, so stress adds to the mix sometimes during the day. I would not dare to even go walk my dogs now. A short grocery store visit at the most.
48 2021-04-14 weakness, pain in extremity, difficulty speaking PAIN LEFT ARM , BACK AND NECK. FEVER AND DRY MOUTH , LEFT ARM EDEMA AREA OF INJECTION, HEADACHE, M... Read more
PAIN LEFT ARM , BACK AND NECK. FEVER AND DRY MOUTH , LEFT ARM EDEMA AREA OF INJECTION, HEADACHE, MALAISE, WEAKNESS, HOARSENESS, NAUSEA AND DIZZINESS TOOK PANADOL
48 2021-04-14 numbness Within 5 minutes my lips, tip of tongue and front area of the roof of my mouth were numb. At 15 minu... Read more
Within 5 minutes my lips, tip of tongue and front area of the roof of my mouth were numb. At 15 minutes still occurring and when I got up to leave the facility I had tightened in my chest, not a pain, but like a charley horse. That tightness lasted about 15 seconds. About 25 minutes after shot I noticed my hands were very swollen. Went home, rested and within two hours hands were normal and tongue and roof of mouth were back to normal. Lips stopped tingling but within a couple of days I noticed that around my mouth and my cheeks were numb. This is still happening and it comes and goes. I went to the doctor 4/13. I do have the start of a sinus infection so taking a Z PAC now. The numbness seems less but it still comes and goes. I have no pain just numbness and stiffness. I told the doctor the best I can describe it is it feels like what Botox looks like (I have never had Botox or fillers).
48 2021-04-14 pain in extremity pain in left deltoid
48 2021-04-15 weakness, flushing, tremor Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chil... Read more
Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
48 2021-04-15 weakness About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both... Read more
About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both arms, hands and right legs, dizziness, pins and needles, extreme fatigue, lethargy, feeling the pulse of my heart rate in various part so my body in an opressive kind of way like in my throat, under my right breast, in my back on the ribs usually. All these symptoms never subsided and became noticeably worse a few days after my second dosis on April 8th. My arms are always numb when I get up and become worse when hanging down, of course, but with different intensity. I am feeling extremely dizzy as I walk around and unstable. Walking feels like the ground is further than it is in a way. I do notice a slight shortness of breath but more of an oppression in the rib cage than panting. I have been avoiding walking far or walking my dogs all together. I am not seeing any improvements even after my visit to the Urgency Care where nothing wrong was found on blood work and EKG. I was told to reduce inflammation with dietary supplement and some vitamins. I cannot work of course and what is a bit frightening now is that I am not improving on day 8 of my second dosis! Same rotation of weird symptoms all day (feeling my blood not circulating normally if that can be described even, numbness, pins and needles in arms, and right leg. Sometimes it affects my right cheek. Dizziness and unstability to walk around. Vision is lower as well. Too weak to do anything constructive. My legs feel like they are not reliable (never have had that feeling at my age). It is more than feeling like a zombie, it is feeling too weak to do anything and my head is sometimes spinning. The numbness can be painful as a sudden thrust in an arm ( this does not last more than a few seconds). It has now been going on since week 3 of my first dosis and today is day 7 of my second dosis! I had 0 symptoms on the first 2 weeks of my vaccine, dosis one. Now, I don't see any progress, rather a slight worsening of all the symptoms above. It is freakish not knowing what I have, of course. One can imagine, so stress adds to the mix sometimes during the day. I would not dare to even go walk my dogs now. A short grocery store visit at the most.
48 2021-04-15 feeling cold High fever 102 degrees Severe headache Chills
48 2021-04-15 feeling hot Woke around 7am with a severe headache and nausea. Developed vertigo (which I thought was related to... Read more
Woke around 7am with a severe headache and nausea. Developed vertigo (which I thought was related to my concussion as I had had vertigo with that, but really not any headaches or nausea) about an hour later. Vomited 3 times between 8am and 3pm. Around 10:30am developed chills and shivering. Felt really ill all day until about 5pm when I felt like I could eat and drink; the headache eased up by then as well. For the next 4 days after this I had sweats that would come and go. I would suddenly and unpredictably get very warm, break out into sweats, and after a short time (5-10 minutes) it would pass.
48 2021-04-15 feeling of body temperature change, tremor Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t qu... Read more
Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t quench my thirst dry mouth unsteadiness
48 2021-04-15 night sweats I started out with a sore neck about 12 hours after the injection. As the day went on, fatigue, sev... Read more
I started out with a sore neck about 12 hours after the injection. As the day went on, fatigue, severe joint pain, general achiness set in. As the day went on I experience brain fog, chills and occasional dizziness. 24 hours after the injections I experience severe chills and night sweats. 36 hours after the injection, most of the pain subsided, but slight fatigue and brain fog remained. I took Tylenol the help with symptoms of pain soon after they began.
48 2021-04-15 pain in extremity DVT Left calf. Started as pain in the left calf on morning after vaccination. Seen by PCP 1 week lat... Read more
DVT Left calf. Started as pain in the left calf on morning after vaccination. Seen by PCP 1 week later with persistent pain. Diagnosed by ultrasound. Confirmed by hematologist and started on Xarelto same day.
48 2021-04-15 tingling Tingling in hands and feet. Ended Monday although continue to have skin sensitivity
48 2021-04-15 tingling Systemic: tingly/fuzzy feeling around nose and upper cheek area-Mild, Systemic: Tingling (specify: f... Read more
Systemic: tingly/fuzzy feeling around nose and upper cheek area-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt had tingly/fuzzy feeling around nose and upper cheek area. She sat in observation for a total of 30 mins, pt was given Allegra and after 30 mins, said she was feeling back to normal
48 2021-04-16 numbness I had diarrhea approximately 4 hours after my second dose. I also experienced dizziness and a feelin... Read more
I had diarrhea approximately 4 hours after my second dose. I also experienced dizziness and a feeling like I was going to faint at about midnight. My face felt a little numb in the morning, around 6:00 am. I also am experiencing fatigue.
48 2021-04-17 weakness, hot flush This all may have been caused from a sinus issue I developed on 4/15/21, the day before I had the va... Read more
This all may have been caused from a sinus issue I developed on 4/15/21, the day before I had the vaccine. 4/16/21-4/18/21 fever 99-100, cough, hot & cold chills, hot & cold flashes, weak, general not feeling well. 4/18/21 one time cough with yellow phlegm from right lung, rest of time regular cough.
48 2021-04-17 weakness, muscle spasms Widespread muscle spasms, pain and weakness over about 1/2 hour. I had a similar, yet more severe re... Read more
Widespread muscle spasms, pain and weakness over about 1/2 hour. I had a similar, yet more severe reaction to chemo and neulasta.
48 2021-04-17 weakness Soreness and body aches set in after going to bed later that night. By 3am, was very weak, thirsty a... Read more
Soreness and body aches set in after going to bed later that night. By 3am, was very weak, thirsty and had increasing pain throughout body, and armpit. Managing pain with tylenol and pain is worse at night when laying down. As of 4/18, armpit is still sore and may be due to enlarged lymph node from vaccine. Cannot lay on it and affects range of motion due to ongoing soreness.
48 2021-04-17 weakness Burning feeling from injection site into right chest and breast immediately. Nausea a couple hours l... Read more
Burning feeling from injection site into right chest and breast immediately. Nausea a couple hours later. Increased pain injection site. Throughout the day. Approximately 8 hours later, severe body aches and pain throughout entire body. Chills. 24 hours after shot, increased severe body aches and pain. Mild Headache. Chills. Overall severe flu like symptoms, weakness in entire body.
48 2021-04-17 tingling A few minutes after administering the vaccine the patient complained of light headedness, vision bec... Read more
A few minutes after administering the vaccine the patient complained of light headedness, vision became spotty, and she felt like she was going to pass out. She also felt tingly fingers and nausea. After a few minutes her blood pressure was checked and it was normal. The light headedness and nausea subsided. The tingly fingers continued for several minutes but later became normal. She drank some water and we provided a fan to help cool her down.
48 2021-04-18 weakness Immediately after receiving the shot, my tongue became numb and tingly, lasting almost two minutes. ... Read more
Immediately after receiving the shot, my tongue became numb and tingly, lasting almost two minutes. I was just about to call for the nurse when it seemed to subside. I felt fine that afternoon, but the following day I had no energy and slept for 12 hours.
48 2021-04-18 weakness 48 y/o female, with no past medical history, who presents with pressure to the side of her head/temp... Read more
48 y/o female, with no past medical history, who presents with pressure to the side of her head/temples, weakness, dryness and numbness to mouth post vaccination administration. Patient received her 2nd vaccination to the patients Right deltoid. Patient denies previous reaction with 1st vaccination administration. NP and Paramedics at patient side. Patient appears pale, including her lips. Patient denies sore throat, difficulty breathing, itch or chest pain. Water was provided and patients legs elevated on chair. Patient vitals within normal limits (initial vitals: 136/86 BP, 99%RA, 83 HR, 12 Resp. Vitals prior to discharge: 123/85 BP, 99% RA, 79 HR, 10 Resp. EKG: NSR ). Patient was monitored by the NP with no further interventions needed. Patient returned to baseline, with symptom resolution within 15 mins. Patient cleared to go home in stable condition.
48 2021-04-18 feeling hot 47 y/o female, with past medical history of Menopause, HTN and environmental allergies, who presents... Read more
47 y/o female, with past medical history of Menopause, HTN and environmental allergies, who presents with feeling hot and throat tightness post vaccination administration. Patient states that this is her 1st vaccination, received in the Left deltoid. Patient denies previous vaccination reactions. NP and Paramedics at patient side. Patient with mild sweating and clearing of her throat. A bottle of water provided, and patient given 25 mg of Benadryl PO x1. Patient vitals within normal limts (initial vitals: 141/98 BP, 98% RA, 80 P, Resp 14. Vitals on discharge: 126/91, 98% RA, 60 HR, 10 Resp). Patient with alleviation of feeling hot and throat tightness within 12 minutes of medication administration. Patient states that throat no longer felt tight and with no difficulty swallowing. Patient cleared to go home in stable condition.
48 2021-04-18 pain in extremity A week after receiving the shot, I started experiencing severe pain in my left calf. On Friday, Apri... Read more
A week after receiving the shot, I started experiencing severe pain in my left calf. On Friday, April 9, I was diagnosed with 2 blood clots in my left leg (Thrombus in the posterior tibial vein on the left.).
48 2021-04-18 pain in extremity My arm hurt for 3 days after the injection. Several hours after the injection, a rash appeared appro... Read more
My arm hurt for 3 days after the injection. Several hours after the injection, a rash appeared approx half in inch from the injection site and still itches.
48 2021-04-18 pain in extremity Shot received at approx. 10:45 am on 4/17/2021. Started feeling very tired in afternoon, by 6pm on s... Read more
Shot received at approx. 10:45 am on 4/17/2021. Started feeling very tired in afternoon, by 6pm on same date, completely exhausted, achy and headache, sore arm, started having chills on and off 4/18/20 - woke up at approx. 4am crying in excruciating pain. I literally hurt from my hair to my toe nails and everything in between. More than regular muscle aches, could barely function. At some point during the day, I developed a fever. Several times checked thru the day, maintained around 100. Complete exhaustion 4/19/20 - woke up approx. 6am. The excruciating pain had moved to extremely sore muscle, still exhausted, no longer have fever. Notice swollen lymph nodes on left side. I have a welt about the size of a baseball located next to my armpit towards my left breast. VERY swollen and painful. Injection site is still sore and very hot. Fatigue is still keeping me from working. I had to call out sick to work today.
48 2021-04-18 tingling My right arm became swollen within 5 minutes of the shot. It started in my finger tips and went up m... Read more
My right arm became swollen within 5 minutes of the shot. It started in my finger tips and went up my forearm and elbow. I experienced tingling in my fingers and a sharp pain in my elbow. My breathing remained normal. I received Benadryl at the testing site. I was advised to continue to take it every 4 hours to alleviate the swelling. It took three two pill doses of Benadryl and icing my arm for the swelling to go down. There is lingering pain in my elbow and wrist.
48 2021-04-18 unresponsive to stimuli ?ti Patient became unresponsive, no pulse was able to be found, CPR initiated immediately and EMS ... Read more
?ti Patient became unresponsive, no pulse was able to be found, CPR initiated immediately and EMS arrived to transfer patient to hospital. Patient was first taken to community Hospital and later was sent to Hospital.
48 2021-04-19 bell's palsy Right Bell's palsy: unable to raise eyebrow, difficulty closing eyelid; unable to smile.
48 2021-04-19 feeling jittery, tingling "48 y/o c/o feeling light headed w/ left arm tingling within a few minutes of receiving second vacci... Read more
"48 y/o c/o feeling light headed w/ left arm tingling within a few minutes of receiving second vaccine dose. Pt states she feels anxious and "" unexplainable"" ? Feels like heart is racing.States there are too many people in here. Denies CP NO SOB Pmhx - Unremarkable Meds- None VS : 136/87 HR: 87 RR : 17 Pt A & O x 3 Appears visibly anxious, jittery, speech coherent but speaks fast Plan: Transfer to ED - symptoms resolved on arrival to ED, patient goes home "
48 2021-04-19 numbness PATIENT REPORTED NUMBNESS ON THE BACK OF ARM AND ALSO IN RING/PINKY FINGER. HAD PATIENT WAIT FOR AB... Read more
PATIENT REPORTED NUMBNESS ON THE BACK OF ARM AND ALSO IN RING/PINKY FINGER. HAD PATIENT WAIT FOR ABOUT 10 MINUTES MORE, CHECKED TO MAKE SURE SHE STILL HAD GOOD GRIP AND FELT WHEN I APPLIED PRESSURE TO ARM. CHECKED IN WITH PATIENT AFTER A COUPLE OF HOURS, SHE STATED THAT "IT IS NOT WORSE, BUT HAS NOT GOTTEN BETTER" SO I ADVISED HER TO CONTACT HER MD. WHEN SHE LEFT, SHE DID STATE " I ALWAYS HAVE WEIRD MED REACTIONS"
48 2021-04-19 tingling Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injec... Read more
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Pharmacist states patient is showing symptoms of shoulder bursitis
48 2021-04-19 throat numbness 1122: SPC notified this RN about this pt's ADRs. Upon arrival, pt stated, "my tongue feels tingling,... Read more
1122: SPC notified this RN about this pt's ADRs. Upon arrival, pt stated, "my tongue feels tingling, numb and back of my throat feels like I have phlegm. It feels weird when I swallow." Pt stated she has epi pen for bee sting, and the s/s she is having is similar as with Bee sting. Pt with her daughter in car, and her husband in another vehicle next to her. 1125: V/S obtained. BP 113/69, 98O2 RA, Resp: 18. Frequent throat clearing, c/o closing up airway at back of throat but no SOB. EPI pen administered over clothes immediately to left superior thigh region. 1130: BP 120/80, 98O2 RA, Resp 18. MAJ informed, and at site.
48 2021-04-20 bell's palsy I now have Bells Palsy
48 2021-04-20 facial pain became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin... Read more
became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; nauseous; light headed; chills; flu like symptoms; arm felt sore/arm at site of injection remains sore; at site of injection remains sore and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (lot number: ER8733) first dose on 30Mar2021 12:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included IDDM (Type 1 diabetes mellitus) and MS (Multiple sclerosis). Patient is not pregnant. No other vaccine in four weeks. No known allergies. Concomitant medications in two weeks included Insulin for IDDM, dimethyl fumarate (TECFIDERA) for MS. Had vaccine at 12:30pm. At 3am (31Mar2021), arm felt sore and felt both nauseous and light headed as well as having chills and flu like symptoms. Went to bathroom and on way back to bed, became faint and passed out onto the floor. Patient hit chin and jaw so hard it was bleeding and obviously very sore and swollen. It's been nearly a week since that incident and arm at site of injection remains sore and itchy. She still feel nauseous at times and her face is still swollen from falling onto the floor and passing out. She was now fearful of having the second dose on 20Apr2021 as due since her reaction to 1st dose was so severe. The outcome of the events was recovering. No treatment for the events. No Covid tested post vaccination.
48 2021-04-20 hot flush, weakness, flushing, pain in extremity Event Symptoms : Headache; Dizzy; Aches; Chills; Nauseous; Flushed face; Hot flash; Sneezing; Fatigu... Read more
Event Symptoms : Headache; Dizzy; Aches; Chills; Nauseous; Flushed face; Hot flash; Sneezing; Fatigue; Sore arm; No energy; Extremely pale; Treatment: Rest; Tylenol; Green Tea Frappuccino; Chicken Noodle Soup; Crackers;
48 2021-04-20 muscle spasms - Persistent muscle cramps (charley horse in both legs, calf and upper leg) started 2 days after in... Read more
- Persistent muscle cramps (charley horse in both legs, calf and upper leg) started 2 days after injection. Have not subside after 24 hours - fatigue started 24 hours after injection. Have not subsided after day 5 since injection - low grade fever started on day 4 after injection
48 2021-04-20 pain in extremity Pain in arm and shoulder, 48 hours Fever of 100.8, overnight, 24 hours Chills, overnight, 24 hours S... Read more
Pain in arm and shoulder, 48 hours Fever of 100.8, overnight, 24 hours Chills, overnight, 24 hours Swollen/painful lymph node on left side only, 48 hours
48 2021-04-20 pain in extremity My arm was so sore on the left side that I could barely move it. I had a fever which got worse over ... Read more
My arm was so sore on the left side that I could barely move it. I had a fever which got worse over time (up to 101 by 2:30 am last night). Also, chills, aching, and a slight headache. I finally ended up taking Advil for the fever sometime around 2:45 am which brought the fever down. When I got out of bed this morning (about 8:30 am) the fever had resolved and the left arm movement was noticeably improved.
48 2021-04-21 feeling cold, pain in extremity, tingling, weakness chills, fever, sweating, all over aches, weakness, loss of appetite, nausea, tired but difficulty sl... Read more
chills, fever, sweating, all over aches, weakness, loss of appetite, nausea, tired but difficulty sleeping, heart racing at times, sensitivity to light, hard to do anything for long (sleep, read, watch TV...)...tough to focus. Pain at injection site, too. Came on about 6.50 hours after getting the 2nd dose. Started with tingles and increased pain in injected arm. Worsened through the night. In middle of night was freezing but my back was completely sweaty and sheets covered in sweat. Was miserable like that through the next day. Was better the day after, and better again day 3, but now on day three still have dull headache, difficulty focusing, am exhausted, and have nausea despite pushing fluids, taking ibuprofen, and resting. Pain in left armpit (injected arm) started yesterday and still have it.
48 2021-04-21 tingling, numbness I felt numbness/tingling in right hand and right foot upon wakening (5:00 AM) on 4/19/2021. I furth... Read more
I felt numbness/tingling in right hand and right foot upon wakening (5:00 AM) on 4/19/2021. I further developed numbness on right side of face around 8:00 AM on 4/20/2021. I went to ER and was admitted to hospital on 4/20/2021. Tests confirmed TIA. Discharged from hospital on 4/21/2021. Numbness persists. Prescribed aspirin, Plavix, and Lipitor while in hospital and upon discharge. Will follow up with family doctor and neurology in next few weeks. Item #21 won't allow me to enter the number of days hospitalized or the hospital name so I will enter it here: I was hospitalized from 4/20/2021 - 4/21/2021 (two days) at Hospital.
48 2021-04-21 tingling About an hour after getting the vaccine in my left arm, I felt a tingling feeling in my left hand an... Read more
About an hour after getting the vaccine in my left arm, I felt a tingling feeling in my left hand and all fingers, like "pins and needles." This lasted throughout the day and evening and subsided the next morning. Additionally, the area around the injection site was slightly swollen/puffy, which lasted about 2 days.
48 2021-04-21 tingling at 1335 pt received 2nd dose of pfizer vaccine and brought to observation area for 30mins to monitor... Read more
at 1335 pt received 2nd dose of pfizer vaccine and brought to observation area for 30mins to monitor by me, escorted by staff, pt already feeling dizzy & hands tingling & heart racing. place in triage chair, vitals measured, assessed, alert and oriented x 3, responds appropriately, clear bilateral equal lung sounds, mild distress with her feeling dizzy asking to lay down on a bed. ask another staff to grab gurney nearby as pt said her dizziness getting worse and eyelids appeared heavier and almost falling off chair while being observed, rapid response called at 1345. pt now on gurney laying supine, Several Vaccine clinic staff assisted me along with Rapid response team, vitals rechecked again at 1350, pt c/o of worsening dizziness and 5/10 headache with hands still tingling, heart still racing. After rapid response team evaluated pt, at 1352 plan to bring pt to ER for further evaluation.
48 2021-04-21 tenderness I developed pain and soreness in my left side breast where I imagine the lymph nodes to be. It felt ... Read more
I developed pain and soreness in my left side breast where I imagine the lymph nodes to be. It felt very tender and inflamed for a few days. I was getting quite worried about to go see my doctor and then I heard that this can happen post vaccine in the side of the shot. I still have some tenderness but it has improved. It was quite painful the type that?s hard to ignore.
48 2021-04-22 burning sensation Patient with immediate burning in arm from injection sight down her left arm to all fingers and into... Read more
Patient with immediate burning in arm from injection sight down her left arm to all fingers and into neck, chest and left leg. Burning pain in left chest and neck lasted 1-2 day. Burning in left arm has been present since 4/8/21 and still present as of today. in last 2 day now weakness in the left arm.
48 2021-04-22 feeling cold Ice cold sensation on upper left arm, gradually extended across upper back. Also extremely drowsy, ... Read more
Ice cold sensation on upper left arm, gradually extended across upper back. Also extremely drowsy, taking multiple naps during day, 4/23. Can't find any information regarding this symptom with the vaccine.
48 2021-04-22 pain in extremity Swelling and painful to the touch under arm, just below arm pit.
48 2021-04-23 pain in extremity ulcers on the side of her tongue and on the inside of her lips; rash with blisters on her hand and b... Read more
ulcers on the side of her tongue and on the inside of her lips; rash with blisters on her hand and back; Blister of lip; Swollen lips; sore arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) on right arm on 12Jan2021 at single dose for covid-19 immunization (to not get symptoms from Covid). Medical history included typically had a strong local reaction to bees or insect bites. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL) for Birth control 1 by daily (had been taking for 15 years and is ongoing). On 12Jan2021, the day patient received the vaccine, she had sore arm which resolved on 13Jan2021. Ten days later on 23Jan2021, she developed a rash with blisters on her hand and back, had blisters/ulcers on the side of her tongue inside her lips and her lips were also swollen and cracked. She states that she treated these symptoms with Benadryl and the rash and swelling resolved. She cannot attribute it to the vaccine. The ulcers in her mouth were better in about a week. She was calling to see if she should receive the second dose of the COVID-19 vaccine and would like to know how effective the Pfizer COVID-19 vaccine is after one dose. Everything that she had seen, this was not a typical reaction. She was wondering if it was safe to get the second dose. She went to the site where she received the vaccine and was unable to get any information. She does not have a physician. The rash has improved. Redness on her skin still can be seen. The blisters on her lips were white places like a canker sore but it was not a canker sore. Her lip was split like mouth ulcers. She took Benadryl and it helped. The outcome of the event ulcers on the side of her tongue was unknown. The outcome was recovered for the events sore arm on 13Jan2021, blister of lip on 31Jan2021 and swollen lips on 01Feb2021. The outcome of the event rash was recovering. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
48 2021-04-23 pain in extremity 4/22-preswnt: Body aches, nausea, vomiting, heart palpitations, chest spasms, pressure around heart,... Read more
4/22-preswnt: Body aches, nausea, vomiting, heart palpitations, chest spasms, pressure around heart, shoulder, arm and rib cage pain.
48 2021-04-24 burning sensation, pain in extremity Day1 11:39 AM after my vaccine I feel a burning sensation thru my arm. 5:00 PM I pain started thru... Read more
Day1 11:39 AM after my vaccine I feel a burning sensation thru my arm. 5:00 PM I pain started thru out my arm and neck. I drink 2 pills of Tylenol for the pain on my arm every 8 hrs. Day 2 More pain on my left arm and swollen finger and chest (cervical ) and I feel a bump in my cervical area .
48 2021-04-24 feeling of body temperature change, weakness Very weak and tired, hot and cold, back of throat and ears soar, under arms and neck sore, nipples... Read more
Very weak and tired, hot and cold, back of throat and ears soar, under arms and neck sore, nipples and bottom of feet burning/stinging. Body aches and nausea. Tylenol, peppermint tea, soak in bath with Epsom salt.
48 2021-04-24 flushing Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic sho... Read more
Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.
48 2021-04-24 numbness, feeling hot tenderness of arm; numbness in fingertips; arm felt hot; numbness in whole arm; This is a spontaneou... Read more
tenderness of arm; numbness in fingertips; arm felt hot; numbness in whole arm; This is a spontaneous report from a contactable consumer reported for herself. A 48-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 07Apr2021 (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. Her appointment was at 13:08 and she might have got the vaccine a couple of minutes earlier than her appointment. Medical history included hypothyroidism from 2007 and ongoing. Concomitant medication included levothyroxine taken for hypothyroidism from 2007 and ongoing. Caller stated she is calling about the first dose of the COVID 19 vaccine. Caller stated she is not sure if this is normal but she just received the first dose yesterday and she did not feel the injection but later she was walking to the car and her arm felt hot and numbness but she just shook it off. Caller stated today, the next day, she felt tenderness of arm, stated this is around the injection, stated just last night she took 2 Advil, and fingertips if she presses them it does not feel the same as the other hand but not fully numb but feels like a numbness sensation. Tenderness of arm was reported as worsened. Outcome of event arm felt hot and numbness was recovered on 07Apr2021, of vaccination site tenderness was not recovered, of numbness in fingertips was recovering. No follow-up attempts are needed. No further information is expected.
48 2021-04-24 muscle spasms, flushing, pain in extremity, muscle twitching, tremor First dose. Immediately spiked heart rate. High blood pressure with bottom over 100. Rash Flushed.... Read more
First dose. Immediately spiked heart rate. High blood pressure with bottom over 100. Rash Flushed. Physical chills (could be seen) head to toe felt drunk. Nausea. Dizzy. Chest pains. Since the first dose I have been getting these tremors and spasms when I sit or lay to relax. My neck arm etc jolts. Second dose. Spike in heart rate and elevated blood pressure bottom 98 Dizziness. Rash. Arm pain and rash (and now heat and 3? bruise on arm site with rash) Chest Pains. Had twitches on the left side in my neck and head.
48 2021-04-24 muscle spasms extremely painful muscle spasm left side of neck for 7 days
48 2021-04-24 nerve pain Soon after my first dose of the Covid vaccine I broke out with reoccurring HSV-2. My best friend al... Read more
Soon after my first dose of the Covid vaccine I broke out with reoccurring HSV-2. My best friend also had the same experience after both doses, although she broke out with both cold sores and genital. We both use Valtrex for outbreaks and it did not seem to work as well as normal. I actually thought the first outbreak was over and another sore started wailed taking the valtrex . This happened to my friend as well. We are still both fighting the outbreaks. The outbreaks are more severe than usual. I just had my second dose yesterday and already feel nerve pain and new sore beginning.
48 2021-04-24 pain in extremity, weakness Can't use arms or legs because they are hurting so badly; Can't use arms or legs because they are hu... Read more
Can't use arms or legs because they are hurting so badly; Can't use arms or legs because they are hurting so badly; Sounds very weak; This is a spontaneous report from a contactable consumer (caregiver). A 48-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization, at the age of vaccination of 48 years old. The patient's medical history and concomitant medications were not reported. The patient experienced can't use arms or legs because they are hurting so badly (non-serious), sounds very weak (non-serious), both on 08Apr2021 with outcome of unknown. Caller was calling for her 49 year old daughter, who received her 1st Pfizer COVID Shot this morning and was experiencing a terrible reaction. She mentioned that her arms and legs were so sore that she cannot get out of bed. She already took Tylenol for it but it did not help. She mentioned that her daughter was healthy and does not get sick often. She was asking how long these side effects may last. Caller reported that she called the patient earlier, and the patient said that she can't use her arms or legs because she was hurting so badly and that all she can do is lay down. Caller reported that the patient was supposed to be traveling to downsouth this weekend to visit the caller. Caller reported that she called the patient to see if she needed anything and that the patient sounded really weak. The patient reported to the caller that she was in bed, her arms and legs hurt so badly, and that was miserable. Caller stated that she is very worried about the patient. Caller inquired if what the patient was experiencing was a common reaction, and how long the side effects will last. Treatment received included the patient took Tylenol. Follow up information completed. No further information is expected. Information about lot/batch number cannot be obtained.
48 2021-04-24 pain in extremity Fever 38.4 for almost 24 hour Headache Fatige and tired Arm pain I took acetaminophen for the fever... Read more
Fever 38.4 for almost 24 hour Headache Fatige and tired Arm pain I took acetaminophen for the fever, pain and headache, rest a lot, and after 24 hour I am okay!
48 2021-04-25 flushing, numbness, tingling, facial paralysis Before I start, I've really tried documenting this to you earlier and it kept timing out on me. Hope... Read more
Before I start, I've really tried documenting this to you earlier and it kept timing out on me. Hopefully the third time is a charm! On Saturday, April 17th at approximately 11:55 am, (45 mins after my shot) I started experiencing partial paralysis to the left side of my face. My cheek bone started to go numb, within the hour, after a weird tingling sensation, it went from my cheek bone down towards my jaw (all becoming numb). This lasted all weekend. I used cold compresses for a little bit at a time just to make the heat coming off of that side feel a little better as my face was flushed. On Monday, April 19th, my lower cheek started to not be so numb. The tingling sensation would come and go from my eye brawl, then the side of my mouth/lip area. I developed a headache that Monday evening. Tuesday morning, my headache was gone. This tingling sensation and partial numbing would last through Wednesday, April 21st. That day, I called my doctor's office and told them about my reaction and to see if they could do some blood work or something. They said that I needed to go to the ER at a hospital for help and to get it documented. Out of all weeks for me to have a side effect, this busy mom had too much going on to schedule an ER visit. My daughter is going into high school and she had auditions and clinics where I had made the choice to figure out I will try to go there on another day. By Thursday, April 22nd, my cheek bone started to become un-numb. The affected side started to feel like the other side of my face. During this entire time, I didn't take any medicine. By Friday, April 23rd, I felt much better. I have more control of my face muscles and I feel like this might be something that was just temporary, but I told myself that if it comes back in any way, I will go to the ER regardless of what is going on in my life. It was a scary thing and now as I look at my card, it reads that the second shot is May 8th at 11:15. I am really scared to get that because who knows what will come from it and I wouldn't want to get anything permanent. I know with traveling, some countries are making it mandatory to be vaccinated. So does this mean that I will not be able to travel if I don't get that second shot. I have no idea what to do with this appointment. Any advice would be great! As of today, April 26th, I feel 95% better on my left side of my face but if I sleep on it for too long, it tends to feel heated at my cheek bone. Aside from that I'm much better. Now onto the second side effect, my left arm muscle was in excruciating pain and I could not lift my arm for two days. It effected my elbow to my shoulder. After Monday, April 19th, my arm started to get better every day. This was the arm that I got my shot in. Today, April 26th, is the first day it seems back to normal. I know you can have a sore arm with this shot, but this was much more than a sore arm. My left side of my face, my left arm, and a headache were the only abnormal events that took place after my first Covid shot. I am thankful to be feeling much better, but will continue to monitor the situation of my face as that is what is most concerning about this vaccination.
48 2021-04-25 flushing urticaria and flushing
48 2021-04-25 mild one side paralysis Head on left side gradually got heavy, vision went blurry, left side weakness, and headache. I had ... Read more
Head on left side gradually got heavy, vision went blurry, left side weakness, and headache. I had been having memory loss and searching for words a few weeks before and just thought it was because I was getting older. Similar symptoms as a TIA. I was driving and more worried about pulling my car to the right and back over from crossing the line.
48 2021-04-25 tingling, numbness she had the vaccine at her local pharmacy. I got this information from her today, and as she seemed... Read more
she had the vaccine at her local pharmacy. I got this information from her today, and as she seemed disinclined to report it, I said I would do it for her. not sure if the pharmacy reported as well. She had nearly immediate onset of left sided facial numbness, unable to feel her lip or left side of the face. No weakness or facial droop. The numbness resolved on it's own over course of 2 days, with some tingling as it subsided.
48 2021-04-25 tingling Tingling in palm of left hand
48 2021-04-26 breast pain Pain in the breast close to the injection site. Felt like a golf ball was under the skin. Lasted for... Read more
Pain in the breast close to the injection site. Felt like a golf ball was under the skin. Lasted for 24 hours.
48 2021-04-26 burning sensation I began breaking out with hives and bumps on my legs, arms, neck, scalp, and hands. It started three... Read more
I began breaking out with hives and bumps on my legs, arms, neck, scalp, and hands. It started three or four days after my second vaccine. The rash began on my legs and over the course of the next two and a half weeks, it spread to different areas. I finally went to an urgent care on April 15, 2021, to get a steroid shot because I was itching uncontrollably. They would not give me one and sent me to my regular doctor. She saw the rash and gave me a steroid shot, a prescription for steroids for seven days, and Hydrzyine for the itching. I'm still having random bumps/breakouts here and there that consist of a couple of bumps at a time. I also felt as if there was a burning underneath my skin during this time. I'm currently rubbing Caladryl on the bumps when they itch. Most are gone, but I did get two new ones a couple of days ago.
48 2021-04-26 difficulty speaking Anaphylaxis. Patient with a h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling,... Read more
Anaphylaxis. Patient with a h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.
48 2021-04-26 feeling hot Had my first shot on 03/26/21 at pharmacy and the second on 04/16/21 LOT#ER8731 at pharmacy. With th... Read more
Had my first shot on 03/26/21 at pharmacy and the second on 04/16/21 LOT#ER8731 at pharmacy. With the first shot I was hot but that symptom went away in the 15 minute wait time, I had acetaminophen and an allergy medication before coming to the pharmacy. With the second shot I had neither before arriving but took them as soon as I arrived home. I work for a bus company and have been driving the same sets of children since January 2021, on last week approx. Wednesday I started to sweat but put it down to the changing weather. Saturday, April 23,2021 I was sweating profusely and thought to drink a lot of water. By Sunday I was experiencing a lot loose diarrhea and thought it would be better to not attend work on Monday, April 26, 2021. I should also mention that the previous week at work my stomach was bothering me and could barely make it to the restroom. The end result is that from Saturday through today Tuesday I have had headaches in the weirdest places the back of my head where the spine meets and in the top of my head. The middle of my forehead and the lower portions of my temporal lobe. I tended to lay down because I would get dizzy and the nausea was getting to be a bit much. No vomiting but I did purchase some Citrus Twist ( similar to Sprite) and that calmed down the nausea. Upon going to the Clinic today I was given a COVID Test and the Clinician suggested a follow up with my Primary, She also suggested that above might be Gastro in nature. Made an appointment and am reporting to VAERS about the possible Adverse Recation.
48 2021-04-26 pain in extremity 1st vaccine dose on Wed 2/10/21 I had no symptoms except my next period started one week late. I wa... Read more
1st vaccine dose on Wed 2/10/21 I had no symptoms except my next period started one week late. I was on the 4th day of my period when I got my second dose on Tue 3/9/21. I thought I had no symptoms except a sore arm from the shot. My period lasted 14 days - heavy flow throughout w some discomfort. I assumed it was over and was surprised when 6 days later I started my period again for 8 days w a heavy flow throughout w some discomfort. I thought that was the end then 18 days later I started my period again for 8 days. Not as heavy but heavier than usual. Hopefully it is weening back to my normal cycle. I can't afford to go to a doctor unless its an emergency - so I'm just dealing with it.
48 2021-04-26 tingling, numbness I felt numbness on right side of face; TIA (mini stroke); I felt numbness/tingling in right hand and... Read more
I felt numbness on right side of face; TIA (mini stroke); I felt numbness/tingling in right hand and right foot; I felt numbness/tingling in right hand and right foot; This is a spontaneous report from a contactable consumer patient. This 48-years-old no pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 08:30 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.Age at vaccination:48 years.Facility type vaccine: Hospital.No other vaccine in four weeks. Medical history included hypertension , well controlled . Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B COMPLEX) taken for an unspecified indication, start and stop date were not reported and multivitamin. The patient stated "I felt numbness/tingling in right hand and right foot when I woke up at 5:00 am on 19Apr2021. On 20Apr2021 around 8:00 AM I felt numbness on right side of face. On 20Apr2021, I went to ER, was admitted to hospital, was diagnosed with TIA (mini stroke). I was discharged on 21Apr2021. I was given aspirin, Plavix, and Lipitor which I will take for the next three weeks and will follow up with family doctor and neurologist. I still have the numbness". The patient was hospitalized for the events for 2 days. Treatment received for the events (hospitalized 2 days, tests, prescription drugs). No COVID prior vaccination. The patient had COVID tested post vaccination (Covid test type post vaccination= Nasal Swab). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Apr2021.Outcome of the events was recovering.
48 2021-04-26 tingling About 30 minutes after getting the shot I had very bad pins and needles both my arms and legs. My wh... Read more
About 30 minutes after getting the shot I had very bad pins and needles both my arms and legs. My whole body felt very tingly all over .
48 2021-04-27 flushing Client reported a feeling of blood rushing through body, lightheaded, and heart palpitations. Vital... Read more
Client reported a feeling of blood rushing through body, lightheaded, and heart palpitations. Vitals taken at 1202: HR87, O2 95%, BP 166/99. No difficulty breathing. client denies any swelling in throat or mouth. Itching in hands and feet. Zyrtec 10 mg given at 1217. Continue monitoring client. At 1240 client reported mild throat tightening and flushing in neck, hands, feet, and top of head. Denies any difficulty breathing. Epi pen 0.3 mg given at 1244. Vitals at 1246. HR94, O2 93%, BP 181/100. Clients son decided to take client to ER. I don't know which hospital. Client left at 1305.
48 2021-04-27 pain in extremity, migraine First day was arm pain, headache, achy feeling. Second day was swollen lymph nodes under arms, swoll... Read more
First day was arm pain, headache, achy feeling. Second day was swollen lymph nodes under arms, swollen injection site, migraine and tired to the point of exhaustion, dizzy. Third day was migraine, dizzy, nose bleed, exhausted, sleepy, rash started on neck then spread to face, chest and forearm, swollen eyes and throat, sores in mouth and on lips. Day 4 went to primary doctor. Day 5 and 6 rash starting to subside with prednisone, Benadryl.
48 2021-04-27 tingling By the afternoon of the first dose, I was tired. At night in bed, I experienced dry mouth, brain fog... Read more
By the afternoon of the first dose, I was tired. At night in bed, I experienced dry mouth, brain fog, faint ringing in ear, tingling in hands and feet, dry eyes, some dizziness. Sensations in muscles, stomach, and bones. It felt like something is circulating around This continued each day 2-4 following this dose. I am concerned about the brain fog and tingling in hands and feet. I am on day 6, and I am experiencing more brain fog, inability to think or remember some things, pain in rib cage, collar bone, and sensitivity in lymph nodes in breasts and throat. I know experiencing longer than average side effects than others. I have seen my doctor on Monday and he is monitoring me for 2 weeks. I am a school teacher. I am concerned. I have had to take 3 consecutive days out this week and need to be at the school to administer state testing by next week. I don't understand why I was not given a good 2 weeks to overcome my effects of vaccination by the school dept. to protect myself, students, and my own family. I took the first dose because others had said that their side effects were minimal lasting only a few days. I had mine done last Thurs of the school vacation. I feel held back from doing my job as a teacher.
48 2021-04-27 seizure Seizure occurred 24 hours after receiving the vaccine that latest about one minutes.
48 2021-04-28 feeling cold about 10 hours after getting the vaccine, i could barely walk. Every joint in my body was sooooooo ... Read more
about 10 hours after getting the vaccine, i could barely walk. Every joint in my body was sooooooo soooooo painful. I broke into sweats, had chills, was cold, and had a bad headache. But the joint pain was by farrrrr the worst. It was EXTREMELY painful. 12 hours later the joint pain subsided. I was all better withing 48 hours. I had to report this though because the pain was severe.
48 2021-04-28 flushing Woke up extreme dizzy 5 days after my first dose. For 2 days straight I was unbalanced, nauseous and... Read more
Woke up extreme dizzy 5 days after my first dose. For 2 days straight I was unbalanced, nauseous and felt flushed but did not run a fever or have any pain anywhere except my arm being sore at injection site. It has gotten better, but I still occasionally feel dizzy and sleeping on my right side seems to make it worse in the morning. I have never felt like this before and do not have a history of vertigo.
48 2021-04-28 tingling, numbness Tingling and numbness in left arm all the way down to fingers
48 2021-04-28 tingling, nerve pain Nerve pain, tingling. Felt like bee stings. Started in left quad area and spread through out body. ... Read more
Nerve pain, tingling. Felt like bee stings. Started in left quad area and spread through out body. Still happening but getting better 2 months later. Also , after second dose experienced extreme brain fog and memory issues.
48 2021-04-29 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-M... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: PATIENT WAS SITTING IN THE MINUTE CLINIC WAITING AREA, SYNCOPAL EPISODE, BP WAS 79/54, HR 71, TEMP 97.9, 02 98% LUNGS CLEAR, 15 MINUTES LATER PATIENTS BP 123/81 HR 74 100%
48 2021-04-29 pain in extremity Sore arm; lateral breast tenderness/swelling.
48 2021-04-29 pain in extremity Extremely sore arm for 36 hours
48 2021-04-29 tingling, tremor A few minutes after injection into left arm, said arm began to feel tingly and heavy. Staff checked ... Read more
A few minutes after injection into left arm, said arm began to feel tingly and heavy. Staff checked on me and suggest I recline, which I did. A few moments later my lips, tongue, lower arms, and lower legs began to tingle and I began to feel light headed. Nurse came to transfer me to ER. While in transit, breathing became a bit erratic, but no sensation of lacking air. By the time I was put in a wheelchair to bring me from the parking lot into the hospital I began to experience tremors throughout the body. Then came nausea and dizziness. Nausea decreased once out of wheelchair. Trembling violently and tingling continued for approximately an hour, after which all symptoms but mild nausea and mild lightheaded sensation subsided. After an additional hour all symptoms subsided. Released from observation at 12:15pm. Tingling in face and lips returning at about 7pm the same evening.
48 2021-04-29 tremor High fever of 102 - 104.1 for 24 hours even with tylenol. Severe body chills and shaking, uncontroll... Read more
High fever of 102 - 104.1 for 24 hours even with tylenol. Severe body chills and shaking, uncontrollable shaking , exessive sweating, severe body aches worst of my life. I was tested back in late March 2021 for Covid and two seperate tests came back unconclusive. This is when there were not enough tests to go around and I was advised to quarentine. Based on the length and severity of my symtoms my Dr believes I actually had Covid and had false positive test, He has also said that his patients that have had Covid or a false-positive that their second dose has more severe side effects than for others that haven't. I was bedriddent for 2 days and am still recovering.
48 2021-04-30 burning sensation, pain in extremity After a few minutes, my vision started to blur in focus. The regular left leg burning became more i... Read more
After a few minutes, my vision started to blur in focus. The regular left leg burning became more intense. I became more off-balance in gait. Within a day or two, I started to experience sharp quick pains in my left arm. The pains in both my left arms and hands grew excruciating over the next 2 two weeks.
48 2021-04-30 hot flush, migraine, muscle spasms breakthrough bleeding; sweats without fever; bad headache,migraine did not respond to benadryl; Cram... Read more
breakthrough bleeding; sweats without fever; bad headache,migraine did not respond to benadryl; Cramping; hot flash; Body aches; chills; it feels like I am about to have a period.; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 13Apr2021 11:00 AM (Batch/Lot Number: ER8727) (at the age of 48-years-old) as single dose for covid-19 immunisation. Medical history included eczema, beef allergy, allergies: Sulfa, on birth control pills from an unknown date. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included BNT162B2, dose 1, administered in arm left on 23Mar2021 10:30 AM (Batch/Lot Number: EW0151) (at the age of 48-years-old) for covid-19 immunisation and experienced first shot just a sore arm like tetanus shot. The patient did not receive other vaccine in four weeks. The patient did not get Covid prior vaccination and did not receive Covid tested post vaccination. The patient stated after second shot, bad headache starting about 12 hours after shot on 13Apr2021 23:00. On 13Apr2021 10:00 PM, body aches, chills/sweats without fever. Similar to having flu on 13Apr2021 10:00 PM. Migraine did not respond to benadryl (usually benadryl or phenergan helps). Headache took about 36 hours to go away. Cramping and breakthrough bleeding the day after shot on 13Apr2021 10:00 PM and continuing today, two days after. She was on birth control pills (for hormones) and was on active row of pills. It's like she forgot to take a pill - hot flash, bleeding, even headache were all things that happen if she was missing progesterone. Headache and most aches gone except it felt like she was about to have a period. Treatment received for event Migraine included Benadryl and no treatment received for the other events. The outcome of the events breakthrough bleeding and Cramping was not resolved, of the event headache was resolved in Apr2021, of the event it feels like I am about to have a period was unknown and of the other events was resolving.
48 2021-04-30 numbness, tingling PT HAS HX TONGUE SWELLING AND FACIAL NUMBNESS/TINGLING WITH FIRST DOSE. HERE TODAY FOR SECOND DOSE. ... Read more
PT HAS HX TONGUE SWELLING AND FACIAL NUMBNESS/TINGLING WITH FIRST DOSE. HERE TODAY FOR SECOND DOSE. DR APPROVED. PT RECEIVED SECOND DOSE OF PFIZER, DEVELOPPED SAME SYMPTOMS BUT MILD THIS TIME, VSS, WAS PREMEDICATED WITIH BENADRYL AND PEPSID, REFUSED TRANSPORT, DRIVEN HOME BY FRIEND, WILL GO TO ER AS NEEDED.
48 2021-04-30 seizure Dizzy; Seizure; lost consciousnesses; don't remember any of it; apparently lost consciousnesses and ... Read more
Dizzy; Seizure; lost consciousnesses; don't remember any of it; apparently lost consciousnesses and drove slowly and hit a pole; "positional vertigo"; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EP8737) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Mar2021, the patient developed positional vertigo after the first dose. On 06Apr2021, the patient apparently had seizure with no history of seizures. The patient also had lost consciousness and drove slowly and hit a pole. They had to break the window to get the patient out of the car. The patient did not remember any of it. The patient stated that it was less than an hour that she was out; from the time recorded on the incident report and waking up in the emergency room (ER) and looking up at the clock in the room, it was under an hour. On an unspecified date, the patient experienced dizzy. The patient lab work and stuff done when she was in the ER after she had the seizure. The outcome of the events was unknown.
48 2021-05-01 weakness, feeling hot Within the first hour, elevated blood pressure. Elevated glucose, headache, nausea, dizziness, diffi... Read more
Within the first hour, elevated blood pressure. Elevated glucose, headache, nausea, dizziness, difficulty catching breath, overheating from shoulders up, extreme thirst and blurry vision. Throughout the same day, continued headache, swollen face, nausea, dizziness, elevated glucose, warmth on spine, weak, kidney pain, back pain, tired and blurred vision. Next couple of days, same as above including brain fog and swelling of all 4 limbs (feet and hands). Continued highly elevated glucose above 400 for fasting reading. After 3rd day, I felt a little better but continued swelling. Still elevated glucose, pain all over body, swelling of joints, pain in joints, could think a bit better, but overall ill feeling. 1-2 weeks after, continued swelling, pain in joints, headache and continued elevated glucose.
48 2021-05-01 pain in extremity 11 days after 2nd Shot - April 6, 2021 - woke up w/ joint pain in fingers, knuckles, wrist in right ... Read more
11 days after 2nd Shot - April 6, 2021 - woke up w/ joint pain in fingers, knuckles, wrist in right hand AND left thumb. I have tried ICE and Ibuprofen / Advil and pain patches. It hurts to open a bottle and write (examples of pain levels). When I wake up in the morning, my right hand is very sore & painful. Highly frustrating and concerning. I was FINE before the Pfizer injection.
48 2021-05-02 hot flush Shortly after the injection I had a minute where my heart rate increased and breathing was short but... Read more
Shortly after the injection I had a minute where my heart rate increased and breathing was short but then is subsided. They driving home about 40 minutes after the shot I had a hot flash and that to subsided. A couple of hours later all the normal sided effect set in but my heart great start to elevate, the GI symptom showed distress with gas, bloating and diharra. Mental issues like confusion are also present. I did not realize these were allergic symptoms until the next morning and I went to the ER how also stated m heart rate was all over the place an I was hpertensive.
48 2021-05-02 pain in extremity The second dose I received on 03/24/21 that same day I experienced chills, the next day, late at nig... Read more
The second dose I received on 03/24/21 that same day I experienced chills, the next day, late at night, pain began in my legs every day the pain increases, today I went to the doctor due to the pain in my legs, the pain no longer lets me sleep
48 2021-05-02 pain in extremity Extremely heavy period. Haven?t had one in 18 months due to pregnancy and breastfeeding. This is ... Read more
Extremely heavy period. Haven?t had one in 18 months due to pregnancy and breastfeeding. This is my 4th child and I never have a period while breastfeeding. This period was non stop bleeding for more than 24 hours. Bright red which is unusual because it shouldn?t be fresh blood since it?s been 18 months. Happened almost 2 weeks after second shot. I also had a lot of post vaccine symptoms after second shot which include fever, chills, aches and breathing issues. Those lasted a week. Tested for coronavirus during that timeframe and was negative. Still bleeding, on 3rd day, still bright red but not gushing like it was.
48 2021-05-02 pain in extremity new onset persistent joint pain to bilateral hands, left elbow and possibly unrelated left calf pain
48 2021-05-02 speech disorder Per safety officer to this writer: Pt DOB 10/2/1972. Pt had first dose of Pfizer vaccine, began feel... Read more
Per safety officer to this writer: Pt DOB 10/2/1972. Pt had first dose of Pfizer vaccine, began feeling dizzy and lightheaded immediately after. Pt stated "its hard to speak". Pt given juice and water. AID called to evaluate Pt. Pt requested interpreter. Pt states she had not been feeling well the last several days, has low grade fever and allergies to ibuprofen (itchy and trouble breathing). 10:19: Pt was evaluated by EMTs, released from EMT care. Pt rested on cot in observation area. RN assisted in calling Pt ride to pick Pt up. Pt reports hx of migraines. 10:46: a friend/relative arrived to pick Pt up and drive her home. 11:14: Pt walked out with significant other to car. VS 1010 BP 120/80 HR 110 RR 24 Temp 99.6F temporal O2 sat 100% on RA VS 1023 HR 85 RR 20 Temp 99.9F temporal O2 sat 100% on RA VS 1033 Temp 98.5F temporal
48 2021-05-03 muscle spasms Very heavy period since second vaccine, extremely painful cramps. Very unusual and not what i am use... Read more
Very heavy period since second vaccine, extremely painful cramps. Very unusual and not what i am used to. Definitely feels different.
48 2021-05-03 night sweats 15 mins after had brain fog and felt buzzed. Had night sweats evening of vaccine and for a few days ... Read more
15 mins after had brain fog and felt buzzed. Had night sweats evening of vaccine and for a few days after first one as well. 24 hours later had bone and joint pain. 28 hours later had heart palpitations and increased heart rate.
48 2021-05-03 pain in extremity Systemic: Allergic: Itch Generalized-Mild, Systemic: Joint Pain-Medium, Additional Details: One hour... Read more
Systemic: Allergic: Itch Generalized-Mild, Systemic: Joint Pain-Medium, Additional Details: One hour after vaccination, patient felt itchy all over and it resolved after taking Benadryl. Two days later, she noticed pain in her hands that worsened gradually. It came and went. She felt like the joints in both hands hurt. She took ibuprofen and that resolved the pain. Hand pain came and went and it permanently went away two weeks after vaccination.
48 2021-05-03 tremor, night sweats Head ache and low grade fever progressed to shaking (not chills) a 102 degree fever with Tylenol ext... Read more
Head ache and low grade fever progressed to shaking (not chills) a 102 degree fever with Tylenol extra strength. Persistent with night sweats through 2.5 days.
48 2021-05-04 weakness This is a spontaneous report from a contactable physician. A 48-year-old female patient received BNT... Read more
This is a spontaneous report from a contactable physician. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 48-year-old, dose 2 via an unspecified route of administration on 17Mar2021 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included Huntington's disease diagnosed in 1995, due to this her voice crackles a bit. The patient's concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EL9263) at the age of 48-year-old, for COVID-19 immunisation and she experienced 4 days of severe nausea, vomiting, couldn't get out of bed, couldn't eat, and diarrhea. The patient got her second dose on 17Mar2021 and had worsening of nausea, vomiting and fatigue on an unspecified date. The patient couldn't keep food down, can't sleep and keeps falling down, and he states "that really concerns me, she's going to knock her teeth out or bleed in her brain, that's not good". She's barely able to get around, doesn't leave unless she has a doctor's appointment. The problem is this, it's not the vaccine, it's the genetic modification this patient has Huntington's disease she was told it was safe, but don't think they took into consideration that it's a genetic modification and she has Huntington's which was also the genetic modification, don't know what to do at this point. He mentions that her nausea and dizziness was getting worse now that were a month out. She's falling down more than before. He wants to help her keep down food because she lost approximately 10% of her body weight. She's dizzy and weak, he states "she's wiped out, not sleeping". He also mentions that she's had hospitalizations. The reported was asking what do to next and if there was an on-staff physician for special cases. Patient reports going to the hospital 8 days after the second shot, she wasn't eating or sleeping. The second shot of Pfizer COVID vaccine was on 17Mar2021, patient began having severe vertigo, falling down, breathing hard, afraid she was going to knock her teeth out or break a bone, insomnia on an unspecified date. Patient reports she took a sip of water and threw up all over the side of the car today 20Apr2021. The Doctor states that this was not normal for her. Patient and reporter stated that the patient has lost between 10-15 lbs, about 10% of body weight. Reporter states that Ivermectin comes in custom lozenges and that it gets rid of inflammation so that it doesn't hurt the whole body. Ivermectin can make the GI upset. Caller states that it was not actually a vaccine that Pfizer was offering, reporter explains that Huntington Disease was when there was a repetitive code in the DNA, to the point it effects muscles and nerves and renders you. What Pfizer and Moderna was offering was a genetic modifier, mRNA was a genetic modifier, not a vaccine. In a Vaccine, they take a piece, make sure its dead, expose it to you and your body makes an antigen, that's a typical vaccine but this is not. Patient says Friday Saturday and Sunday she was stuck in the house. She cannot do anything. Reporter says the patient needs professional help. Her voice fluctuates so people take her seriously. (institute name), told the patient it would be ok to take the Pfizer COVID vaccine, but they didn't take into consideration is it was a genetic modifier. This was not a typical vaccine. Reporter states that he needs help escalating this please help with escalating this, needs help to know what to do for this patient because of the MRNA genetic modification. The mRNA may have affected the Huntingtons. The events resulted to hospitalization except for vertigo and breathing hard. The outcome of the events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
48 2021-05-04 weakness Increased weakness - Guillain-Barre Syndrome
48 2021-05-04 breast pain Patient experienced runny nose, cough, congestion, arm and breast pain. Patient reported back pain. ... Read more
Patient experienced runny nose, cough, congestion, arm and breast pain. Patient reported back pain. Patient has been taking extra strength tylenol. Patient has not done a rapid test for COVID.
48 2021-05-04 cold sweat About 5-7 minutes after the shot I became incredibly light headed and felt like I was going to pass ... Read more
About 5-7 minutes after the shot I became incredibly light headed and felt like I was going to pass out. Soon after my throat felt closed and I could not breathe. My blood pressure when checked was around 240/190, I was clammy and my tongue felt swollen, couldn't speak. Lasted about a 20 minutes. Was given IV steroid and IV Benedryl.
48 2021-05-04 pain in extremity, numbness, muscle spasms, tingling, tenderness Lump that has not gone away since April 20th. Over 2 weeks. Muscle cramping and weakness. Still te... Read more
Lump that has not gone away since April 20th. Over 2 weeks. Muscle cramping and weakness. Still tender to touch. Pain sometimes radiates up to neck and down to left hand. Sometimes numbness and tingling. Left hand and fingers cramp up when holding something where that has never happened before. Can't sleep on my left side.
48 2021-05-04 tingling 1545 Pt reported feeling sharp pain when breathing in. 1600 Pt reported tingling bilateral arms and ... Read more
1545 Pt reported feeling sharp pain when breathing in. 1600 Pt reported tingling bilateral arms and back of neck. 1615 Pt reported sharp pain upon breathing had resolved. Tingling sensation beginning to go away.
48 2021-05-04 tremor itching/burning sensation on skin, but not everywhere, lightheadedness, congested feeling in throat,... Read more
itching/burning sensation on skin, but not everywhere, lightheadedness, congested feeling in throat, shaking all over- were worst ~50 minutes - 3 hours after injection systemic allergic reaction Took 2 benedryl at pharmacy, where I tried to get an epinephrine shot - I thought I would get faster treatment there than ER- was a mistake Believe should have gone to ER; friend wanted to take me I categorized as life threatening below - think I was just really fortunate Did not have what I would consider significant reaction to first injection-- no allergic reaction; very minimal immune response side effects - felt a little like I might get sick
48 2021-05-05 flushing POST VACCINE, REPORTED FLUSHING AND HEART PALPITATIONS/RACING HEART. BROUGHT BACK TO OBS VIA WC FOR ... Read more
POST VACCINE, REPORTED FLUSHING AND HEART PALPITATIONS/RACING HEART. BROUGHT BACK TO OBS VIA WC FOR VITAL CHECK. STATES HAS HAD THESE IN THE PAST AND HAVE RESOLVED UPON ARRIVAL TO OBS. VSS, ESCORTED TO EXIT WITH NO FURTHER ISSUES ONCE S/S RESOLVED COMPLETELY AT 1004. INSTRUCTED BY ON SITE MD TO SEEK FURTHER EVAL/TREATMENT IF RETURN/PERSIST/WORSEN. 0958 BP 135/85 HR 94 RR 18 SATS 100% RA 1000 BP 126/90 HR 88 RR 18 SATS 100% RA
48 2021-05-05 numbness Sunday April 11 12:30pm ? injection left arm dose 1 12:32pm My fingers went numb 5:30pm my arm star... Read more
Sunday April 11 12:30pm ? injection left arm dose 1 12:32pm My fingers went numb 5:30pm my arm started to stiffen up (took Tylenol 2x at 4 hour intervals) 8:00pm hives and reddening at/around injection site (applied benadryl cream) Chills and fever set in 10:30pm terrible nausea and fatigue Monday: Called out of work Body aches Terrible fatigue was in bed all day long felt drugged up Very thirsty and lethargic Tuesday Hard to wake up Body aches Struggled to drive to the office ? Neck is hurting and It?s hard to keep my head up right
48 2021-05-06 weakness, seizure I was called onto the scene around 1:25pm and was told by the manager on site to help with a patient... Read more
I was called onto the scene around 1:25pm and was told by the manager on site to help with a patient who was feeling lightheaded. I went with one of the workers in the building who was able to obtain information from the patient that she had a history of epileptic seizures and directed me to the patient with a wheelchair. When I arrived on scene, which was a few hundred yards away in the convention center, there was a bystander there to help the patient and security a few yards away. I asked the patient how she was feeling and she stated that she was feeling weak and light-headed. I brought her over to a dark lighted area, via wheel chair, 10 yards away and laid her in on the ground to get maximum amount of blood flow to the brain. I was able to get her history, which she did not have allergies, and gave me the the information regarding her seizures that occurred every month to two months. As I asked about her medications for the seizures, first focal epileptic seizure started. The patient was away from all anything that could obstruct her and the seizure lasted for one minute. After this, colleagues and two EMS personnel from the convention center came on scene and the colleague dialed 911 after I stated that the patient had a seizure. The patient recovered, was able to obtain pulse, which was just over 100 bpm, and asked her questions regarding her name, time, place, and event and the patient was able to correctly respond. The patients skin was warm and was only brought to a sitting position when she needed to sip on water. I was able to give information to the dispatch during the call and monitored pulse and breathing. She was willing to go to the hospital when EMS arrived. The second focal epileptic seizure was five to seven minutes after the first one and again lasted for a minute. Again, the patient was alert and oriented to name, time, place and event. The patient was able to give me her ID and as I was getting her pulse and further information, a third focal epileptic seizure took place and this is when the EMS unit came on scene. They were able to take care of the patient and obtain vitals (130/90 blood pressure, just over 100 glucose). The patient was carefully sat up from the ground, laid on the cot, and the EMS unit transported the patient to a hospital. I signed witness to the security as to what happened and actions taken.
48 2021-05-06 burning sensation, tingling, flushing Roughly 6 minutes after shot, I started feeling tingling in my right arm (opposite arm that the shot... Read more
Roughly 6 minutes after shot, I started feeling tingling in my right arm (opposite arm that the shot was given in). Thee we tingling, pulsing and electric shock feelings continued for about 30 minutes. I felt them in my arms, legs, hands, back. It was not painful, but I felt like my body was being stimulated. I reported what I was feeling and the nurses expressed concern. Asked if I had any allergies (no). I explained that I had taken Ubrelvy for a migraine the days before. My face started to feel flush. Breathing was not affected. I eventually felt well enough to leave, but was told yo report my symptoms to the CDC.
48 2021-05-06 difficulty speaking 20 minutes after the vaccine?Throat started feeling funny, then felt as if something was stuck in my... Read more
20 minutes after the vaccine?Throat started feeling funny, then felt as if something was stuck in my throat and then voice stated sounding horse raspy. Slight dizziness in my head.
48 2021-05-07 tingling Got really inflamed and everything again; Brown-Sequard syndrome; Brown-Sequard syndrome; Tingling i... Read more
Got really inflamed and everything again; Brown-Sequard syndrome; Brown-Sequard syndrome; Tingling in both legs; legs getting swollen; whole left side of body swelling only from under the breast down; muscles tightening on the whole left side of body only from under the breast down; continued discomfort in left leg; Swelling makes it to where her joints can't like she can't bend her knee really well; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Apr2021 at 10:15 (Lot Number: EN6201), as single dose, for COVID-19 immunisation. Medical history included ongoing Brown-Sequard syndrome, ongoing diabetes mellitus, COVID-19 from 14Feb2021 to 2021 (for about 3 weeks), ongoing immunodeficiency. Concomitant medication included semaglutide (OZEMPIC) for diabetes mellitus. The patient experienced Brown-Sequard syndrome exacerbation (medically significant) on 01Apr2021 with outcome of unknown, tingling in both legs (non-serious) on 01Apr2021 with outcome of unknown, legs getting swollen (non-serious) on 01Apr2021 with outcome of unknown, whole left side of body swelling only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, muscles tightening on the whole left side of body only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, continued discomfort in left leg (non-serious) on 01Apr2021 with outcome of unknown, swelling makes it to where her joints can't like she can't bend her knee really well (non-serious) on 01Apr2021 with outcome of unknown, got really inflamed and everything again (non-serious) on 21Apr2021 with outcome of unknown. Patient reported that had swelling in the areas that normally, like the left side of her back, her stomach, all the sites that basically the Brown-Sequard Syndrome that she has problems with, it just exacerbated it. Follow-up attempts are completed. No further information is expected.
48 2021-05-08 flushing Symptoms & time course 03/31/21: Within 2-3 min after taking the Covid-19 Pfizer shot in my left up... Read more
Symptoms & time course 03/31/21: Within 2-3 min after taking the Covid-19 Pfizer shot in my left upper arm, my entire arm became nearly 80% immobilized ( I felt that I was going to lose my arm movement completely but it came back). In about 5 min time, I felt a strong stomach disturbance (something like stomach diarrhea) briefly for a few seconds, and then my heart rate increased suddenly a lot and I felt a strong gush of heat coming out of my face and upper half of the body, and then I started to feel unwell. I also felt moderate pressure in my ears and the head wasn't feeling well either. My hands and fingers were trembling a lot. The paramedics checked my vitals, I think the blood pressure was around 117/62 and pulse was around 85. After another 5 minutes or so, I started to feel better. For the next 2-3 hours post-vaccination, I had felt mild symptoms of headache, nausea, and sensation of cough in the throat. Few times I also felt mild sensations of chest discomfort and that I may develop some difficulty in breathing or shortness of breath, and once I also felt a mild sensation of throat moving up and down (no throat closure), and none of these symptoms had developed to that of a higher intensity such that someone else could see them happening. About 5 hours post-vaccination (i.e. around 8:30 pm) I felt that I have a reaction going on in the body which continued for an hour. About 6 hours post-vaccination (i.e. around 9:30 pm), I felt that the reaction that was occurring in the body had ended with the skin on both of my arms becoming red in color and the skin texture was looking like that of a burnt skin (I did not take a picture of the arm with skin redness). The whole-left-arm had swollen relatively more than the whole-right-arm and I also noted mild swelling in the left arm wrist and palm. Also, a large part of the muscle just above the elbow on the left arm had swollen a lot (appearing like a bump) with muscle stiffness, and this muscle bump was mildly painful if you apply pressure on to it. There were also some mildly painful nodules in the upper left arm and the arm muscles generally appeared to be hardened. The veins & some arteries also appeared more prominent in the left arm compared to the right arm. I had noted that the swelling and redness in both the arms had started to decrease after 30 min of appearing and got reduced a lot more after about 2 hours (i.e. 11:30 pm). There was also a very mild facial swelling at night and I had felt feverish for about 25 min or so. 04/01/21 Next day early morning (i.e. 6 am) I noted abdominal or stomach bloating of higher magnitude, and I wasn't feeling very well with some mild sensations of throat moving up and down and a feeling that I may develop shortness of breath but these symptoms did not develop in higher intensity and began to subside after about an hour. As the day progressed, I started to feel better and by afternoon all of the symptoms were better except that the swelling and a hive (or muscle bump) on the left arm were still present. I also had moderate soreness around the site of injection in the upper left arm. 04/02/21 Next day morning the swelling and hive (or muscle bump) in the upper left arm were getting better but had not completely gone. By the end of the day the arm swelling had mostly subsided and the large muscle bump in the upper arm had reduced in size but still present with a mild pain. The left upper arm soreness around the site of injection had reduced. 04/03/21 & 04/04/21 The hive or (muscle bump) in the upper left arm was highly reduced in size but still present with a mild pain on applying pressure. 04/05/21 I felt some minor chest discomfort and minor pain repeatedly for a few seconds during the afternoon hours while at work. These symptoms subsided by evening hours. 04/06/21 I felt a mild chest congestion with a little bit of phlem in the chest at night which then got better after an hour or so. 04/14/21 I noted a rash on the left side of the lower neck (just above the shoulder) which extended from the left-side of the neck towards the center of neck, at night (i.e. 11:45 pm). The intensity of redness had reduced in the next 30 min or so and the rash was nearly gone by the next day morning. Final outcomes: The allergic reaction symptoms that I had developed after taking the first dose of Covid-19 vaccine from Pfizer-BioNTech had mostly resolved on their own in a week. I did not take any medications to help relieve the allergy symptoms. Concerns and queries: 1) Would it be safe for me to take a second dose of Covid-19 vaccine from Pfizer-BioNTech? 2) Would an anti-allergy medication be helpful to take before receiving a second dose of Covid-19 vaccine from Pfizer-BioNTech? 3) Is it safe to receive a Covid-19 vaccine from a different company (e.g. Johnson & Johnson or Novavax)? I am presently partially vaccinated.
48 2021-05-08 tenderness Insane sweating of only my head face and neck. A lot of canker sores. Mild Sore throat. Joint pain... Read more
Insane sweating of only my head face and neck. A lot of canker sores. Mild Sore throat. Joint pain. Tiredness. Terrible neck pain at sight of previous surgery. Mild Tenderness of old scars. Shoulder, elbow, hip,ankle wrist joints painful.
48 2021-05-09 burning sensation, pain in extremity, discomfort, numbness Starting 6 days after the vaccination, I began to have itching, burning, discomfort and aching in th... Read more
Starting 6 days after the vaccination, I began to have itching, burning, discomfort and aching in the muscles of both buttocks symmetrically. It progressed bilaterally down to the soles of both feet over the course of 10 days. I had numbness in a saddle distribution, with multiple patches of cutaneous anesthesia from waist down. I lost feeling in my genitalia. I had urinary frequency, urgency and nocturia. I became constipated with little to no bowel movements for almost 2 weeks. Laxatives did not provide relief. It was very painful to sit at first. 7 days into the progression of symptoms it also hurt to stand. I could not extend my legs at the knee.
48 2021-05-09 feeling cold, weakness 1st shot - tired, fatigue. Had it on Thursday, pretty much slept all weekend and took Monday off wo... Read more
1st shot - tired, fatigue. Had it on Thursday, pretty much slept all weekend and took Monday off work and took it very easy Tuesday Wed. Discontinued my working out (running several miles, training) for >14 days. 2nd shot- April 30, Injection site soreness in my left arm again but felt fine, even ran on Sunday afternoon, then it VERY suddenly hit me around 430 pm- nauseated, tired, dizzy, progressively weaker from run, to walk, to barely being able to sit up-felt very wrong. 2 hours later - my entire GI system went crazy - intense pain / cramping, very forceful multiple episode vomiting (I have only vomited a few times in my life, most recently a few years ago when I got very motion sick on a flight, and it was NOTHING like this), and severe diarrhea. This continued all night- I had to lay on my left side and every 30 minutes or if I moved at all, my entire guts cramped up, and I had very forceful vomiting and diarrhea, to the point I could taste blood and there was blood in the toilet. I was extremely cold. Temp only 98.8 though. This lasted for 14 hours. After that, the cramping lessened although still everything passing right through me. I could not get out of bed for 2 days, but gradually felt better and by the weekend could walk a few miles.
48 2021-05-09 muscle spasms I am reporting my SIDE EFFECT!! I had all the risks that have been reported and posted as side effe... Read more
I am reporting my SIDE EFFECT!! I had all the risks that have been reported and posted as side effects: injection site pain, leg cramps, headache, tiredness, chills, sweating, severe nausea, feeling unwell. muscle pain. I used Motrin for treatment, plenty of fluids and rest for days.. I am reporting since I feel these symptoms should be reported as I felt unwell for several days and I would not describe as minor where one could go to work or function as normal for a few days. I was in bed for two days after both of my shots. Education was not very clear where to post or if you should post side effects/risk of shot. I know not every patient had symptoms after shot so I am reporting in the event this is acceptable form of feedback.
48 2021-05-09 nerve pain, weakness, numbness After first shot, felt like balance was completely off and head was dizzy (most noticeable when driv... Read more
After first shot, felt like balance was completely off and head was dizzy (most noticeable when driving on highway). After 2nd shot, experienced numbness and burning pain in the nerve endings up and down my legs (especially the back of my legs), arms, and general weakness in limbs.
48 2021-05-09 pain in extremity Extremely sore arm; 102 degree fever for 36 hours; ringing in ears for about two weeks.
48 2021-05-09 tingling, pain in extremity, migraine Left arm pain, within a couple hours, Muscle pain, joint pain, vomiting, migraine, exhaustion, withi... Read more
Left arm pain, within a couple hours, Muscle pain, joint pain, vomiting, migraine, exhaustion, within 8-10 hours Arm tingling and numbness entire left arm and hand and partial right from Elbow to hand within 24-36 hours that is prolonged and does not seem to be getting better. Very difficult to use my hands.
48 2021-05-10 burning sensation, discomfort One day after my second vaccine I began to have burning, pain and pressure in my pelvic and back are... Read more
One day after my second vaccine I began to have burning, pain and pressure in my pelvic and back area. My urine color turned black/purple color.The color lasted for about six days and I am still having pelvic pain.
48 2021-05-10 flushing 1415: approximately 10-15 minutes after vaccine; patient c/o flush & dizziness in 30 minute observat... Read more
1415: approximately 10-15 minutes after vaccine; patient c/o flush & dizziness in 30 minute observation area. Skin pink, cool, and diaphoretic. Pt reports eating lunch before vaccine. PMHx: Diabetes, Allergies: PCN-Anaphylaxis Meds: Metformin, Glipizide, Prevastatin Patient in First Aid area for assessment and observation. A & O x 4, Speech without difficulty. Denies any other symptoms of reaction. 1419-VS: B/P: 160/100, HR 100, RR-18, O2 Sat: 96% on RA CBG-314; patient in between PCP's for medication adjustment. 1437 VS: b/p: 144/86, HR 99, RR 18, SaO2 95% on RA Cool Towels applied to neck, water given 1455: Symptoms resolved, patient cleared to leave by paramedic on duty.
48 2021-05-10 muscle spasms, pain in extremity menstrual cramps; fatigue; dull headache; cramping in her hands and feet/cramping in her hands; blue... Read more
menstrual cramps; fatigue; dull headache; cramping in her hands and feet/cramping in her hands; blue bruising to her right foot; fever; soreness of the arm; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration (dose: 02) on 16Apr2021 as single dose for COVID-19 immunization. The patient's patient medical history and concomitant medications were not reported. On 16APR2021 patient received her second dose of vaccine and had typical effects 24-48 hours later including fever (Apr2021), soreness of the arm (Apr2021), fatigue, a dull headache, menstrual cramps, and blue bruising to her right foot, which is a little bit unusual. She also added that she was menopausal, and she had very severe menstrual cramps. However, all of that passed, except for the really dull headache and fatigue, which had lasted pretty much a whole week. The headache and fatigue are just not dissipating. With the fatigue, she can barely keep her eyes open. She's barely been functioning this week because of it. She stated that she knew that these symptoms were pretty normal within the first 48 hours but she was almost a week in and she was still having some of these symptoms. Patient had cramping in her hands and feet, which started at the night of the vaccine on 16Apr2021. It almost felt like dehydration cramps that one has in their feet, hands/palms, muscles- she clarified that further like sporting dehydration cramps. Within the 48-hour time period after the shot, she had menstrual cramps. She thought that was unusual since she no longer has her period anymore. However, all of these symptoms besides the dull headache and fatigue went away- those were all within 48 hours. The only thing that was really unusual to her was the cramping of her hands and feet, the bruising of her feet, plus the menstrual cramps. The other side effects seemed to be aligned with what they said the expected side effects are. However, now the only thing that has lasted is just this dull headache. She does not generally suffer from headaches. The menstrual cramps appeared 2 days after receiving the vaccine, on Sunday 18Ap2021. There was a 2 hour period where she had the cramps and then they disappeared. She went into menopause last year so she hasn't had a period in a year or since being in menopause, so it was odd to suddenly have menstrual cramps. The fatigue started on Saturday, 17Apr2021. She explains Saturday, the fatigue was the worst. She clarifies all of the symptoms were the worse on Saturday, 17Apr2021. The fatigue was just ongoing. She normally does not ever take naps during the day but yesterday, she had to sleep 5 hours in the middle of the day because she was so exhausted. It was just like she can't even keep her eyes open, and she just has to go lie down. She had to stop what she is doing and go to sleep. She clarified that every day since she received the injection, she had to sleep/go lay down and nap in the afternoon because her eyes are physically closing. Patient confirms that the headaches started on Saturday, 17Apr2021. She explained that it was a dull headache that goes all the way across her brow. These headaches were still ongoing. It was not like a migraine and it was just a persistent headache and there all day long. She doesn't usually suffer from headaches ever, it's discombobulating, it's just a dull pain that will not go away. The outcome of the event was recovered on 18Apr2021 for Menstrual cramps; not recovered for Headache dull, fatigue and was unknown for other events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
48 2021-05-10 pain in extremity swelling behind the knees and swelling of the veins; it had to do with blood clot warnings / it was ... Read more
swelling behind the knees and swelling of the veins; it had to do with blood clot warnings / it was some kind of clotting because of the position of the areas of swelling.; she got like three balls on the right arm; pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm; the lymph nodes in left armpit got swollen; swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow; This is a spontaneous report received from a contactable consumer. A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:30 (Batch/Lot Number: ER8729) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced it had to do with blood clot warnings / it was some kind of clotting because of the position of the areas of swelling on 15Apr2021, swelling behind the knees and swelling of the veins, swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow on 12Apr2021, the lymph nodes in left armpit got swollen on 13Apr2021, pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm on 14Apr2021, she got like three balls on the right arm on 15Apr2021. The patient underwent lab tests and procedures which included ultrasound scan: unknown results.She was calling because she got her shot on 12Apr2021 and then she ended up having swelling behind her knee, then she had swelling under her armpit and swelling on her right arm below her elbow. She stated that they weren't lymph nodes, and she went to the ER (EmergencyRoom) had to check and see if they were blood clots. She stated that it turns out that her veins were swollen underneath her arm. She said that was what happened after the shot and that was her first shot. She states so that's her report on what happened. She stated she got the shot in the morning so her symptoms at 6 or 7 pm that evening. She stated she went to the doctor first and then went to the hospital. She went to the doctor on the 16Apr2021 and the hospital on 16Apr2021. She stated that the swelling behind her knee went away on 20Apr2021.Tuesday, 13Apr2021 the lymph nodes in left armpit got swollen. On Wednesday, 14Apr2021, there was a pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm. On Thursday, 15Apr2021 she states she got like three balls on the right arm, on her elbow on the right side. She went to the doctor on Friday 16Apr2021 she went to the ER (emergency room) because they couldn't figure out if it was some kind of clotting because of the position of the areas of swelling. She got an ultrasounds for them to check her blood flow. She stated that the pain in her left arm was going down but didn't resolve until the 22Apr2021. For the little balls on her arm, the MD (Medicne Doctor) gave her a medication for the swelling of her veins but she forgot the name and she doesn't have the paper with her. She states the balls of fluid went away between the 20Apr2021 and 22Apr2021. Everything starting going away that week.She states it had to do with blood clot warnings, and swelling under her skin had to do with the veins. Outcome of with blood clot warnings was unknown, like three balls on the right arm and pain in her left arm from the armpit to the elbow was recovered, remaining events was recovering.Therapeutic measures were taken as a result of swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow, she got like three balls on the right arm.
48 2021-05-10 tingling Patient had tingling in fingertips and itching in left leg within 15 minutes of vaccination. Patien... Read more
Patient had tingling in fingertips and itching in left leg within 15 minutes of vaccination. Patient improved and was released to home.
48 2021-05-10 tension headache Left side of her face swelled up; whole cheek on the left side swelled up; Soreness when she eats, l... Read more
Left side of her face swelled up; whole cheek on the left side swelled up; Soreness when she eats, left cheek is still tender to the touch; Her jaw would get tight as if it was clamping when she eats; Tension headaches; This is a spontaneous report from a contactable consumer. A 48-year-old female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EW0161, NDC number, expiry date; unknown, this information is not on the CDC vaccine record card.), Pfizer product, Pfizer Covid Vaccine manufacturer; unspecified, via an unspecified route of administration on 19Apr2021 at 02:15 pm at single dose (Dose: Unknown strength/volume/dose injection) in right arm up by the shoulder area for covid-19 immunization (Wanted to get the vaccine to be safe from COVID). Vaccination facility type was reported as unknown. Vaccine was administered at military facility. Patient Age at Time of Vaccination in Years was unknown. Patient's medical history included hearing impairment (Additional Information for Other Conditions; She has a cochlear implant, is completely deaf. She had cochlear surgery she believes in 2012. Onset date of hearing impairment unknown), high blood pressure (Onset date unknown other than shortly after cochlear surgery), guessed she is a little bit obese (dates unspecified). AE(s) following prior vaccination were reported as 2 weeks prior to cochlear surgery she had to receive a special type of meningitis vaccine and for probably 1 week she had a 102 degree fever and swelling in her entire face. She was admitted to the hospital but they never found out why. After being in the hospital maybe by the second day she started feeling better and the swelling went down, she had no more fever; but they kept her in the hospital for a whole week. This event is why she is thinking the events after the Pfizer Covid Vaccine could be related to the Pfizer Covid Vaccine; because her reaction following the special type of meningitis vaccine was similar to the events after the Pfizer Covid Vaccine, although not exactly the same. Vaccine/Brand Name; Unknown brand name-only known as a special type of meningitis vaccine specifically for people with a cochlear implant: Lot/NDC/Expiry unknown, caller does not have this information to provide. Vaccination Date; 2 weeks prior to cochlear surgery-cochlear surgery was in 2012. Family history and relevant tests were reported as none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EW0150) NDC/Expiry: Unknown, this information is not on the CDC vaccine record card, Dose: Unknown strength/volume/dose injection to right arm, up by the shoulder area via an unspecified route of administration on 29Mar2021 at 02:45 pm at single dose for covid-19 immunization. Patient's concomitant medications included losartan from an unspecified date in 2019 to ongoing for high blood pressure, amlodipine besylate from an unknown date in 2019 to ongoing for high blood pressure. Additional vaccine administered on same date of the Pfizer product was reported as none. Prior vaccination within 4 weeks was reported as none. Consumer was calling to report side effects after receiving a dose of the Pfizer Covid 19 vaccine. She has no MI questions at this time. No details of her side effects were given. The report was not related to a study or programme. Pfizer Covid Vaccine; Dosage previously discontinued/treatment completed. Investigation assessment; no. This consumer is the patient who called regarding Pfizer Covid Vaccine. She has been administered both the first and second doses of Pfizer Covid Vaccine. She is not sure if the events she experienced following the Pfizer Covid Vaccine are related to the Pfizer Covid Vaccine. She reported tension headaches on 21Apr2021; soreness when she eats on 23Apr2021, onset time unknown, outcome improved, she can chew food without any pain, but her left cheek is still tender to the touch.; her jaw would get tight as if it was clamping when she eats on 23Apr2021, Onset time unknown. Outcome: Consumer only able to provide that tightness in jaw has stopped, further to date and outcome details unknown.; left side of her face swelled up on 26Apr2021 when it really was noticeable. Onset time unknown other than she thinks that night. Her whole cheek on the left side swelled up; but the swelling was just in the back by the jaw where the ear was, with swelling and tightness. She noticed her face started swelling up from her jaw to the ear. She has been taking Benadryl for event. By now the swelling is going down, her whole left cheek is still swollen on left side but improved. Started improving, going down on 27Apr2021. She did not read anything about left side of her face swelled up event. Asked for further information regarding the events she experienced relative to the Pfizer Covid Vaccine. Tension headaches are gone, tension headaches started easing maybe evening of 22Apr2021 and stopped probably that same evening after taking maybe a total of 4 Tylenol that day for the Tension headaches. Outcome specifics unknown other than stopped. The reported events did not require a visit to emergency room or physician's office but she has an appointment scheduled with her doctor for this coming Saturday, 01May2021. The patient was not hospitalized. Reporter seriousness for events was unspecified. The outcome of event tension headache was recovered on 22Apr2021, pain was recovering, tightness in jaw was unknown, swelling face was recovered on 27Apr2021 and cheek swelling was recovering. No follow-up attempts are needed. No further information is expected.
48 2021-05-10 tremor, pain in extremity Severe shaking started 14 hours after injection, along with chills. About 20 hours after injection,... Read more
Severe shaking started 14 hours after injection, along with chills. About 20 hours after injection, low-grade fever, severe headache started. General feeling of tiredness, sore arm and achy accompanied. Lasted all together about 24 hours from onset of adverse effects.
48 2021-05-11 weakness pt came back feeling lethargic and weak stated she did not have anything to eat so pt was given appl... Read more
pt came back feeling lethargic and weak stated she did not have anything to eat so pt was given apple juice pt confusion became elevated and pt unable to keep eyes open pt didint know where she was ems called pt had panic attack when 5 ems personnel were in the room calmed down then sent to the hospital pts daughter came and went to hospital with her
48 2021-05-11 migraine, numbness Worse migraine headache of my life accompanied by numbing of my scalp, dizziness and nausea. On 05/0... Read more
Worse migraine headache of my life accompanied by numbing of my scalp, dizziness and nausea. On 05/09/21, the headache impacted my left side; on 05/11/21 it affected my right side. Both days, I was completely incapacitated for 5 - 6 hours. The headache was followed by postdrome lasting 5-6 hours that affected my steadiness/proprioception. I have a long history of tension and migraine headaches. Never experienced anything like this. I took Tylenol and used ice packs and massage for relief. The ice was most helpful.
48 2021-05-11 pain in extremity First dose just severe pain of the left arm Second dose: strong headache, light headed, chest pain, ... Read more
First dose just severe pain of the left arm Second dose: strong headache, light headed, chest pain, burping, stomach pain, legs pain on the back side of both legs, then leg pain only on upper back side.
48 2021-05-11 pain in extremity red sore very painful fingers. clinically appears as chilbalins. patient described reaction beginni... Read more
red sore very painful fingers. clinically appears as chilbalins. patient described reaction beginning 5 minutes after receiving the vaccine. reaction persisted for 2 months.
48 2021-05-12 nerve pain Swelling through out body but prominent on the right side. swelling in lymph nodes in right arm pit,... Read more
Swelling through out body but prominent on the right side. swelling in lymph nodes in right arm pit, and on neck and shoulder area. swelling in my face sinuses, ear, legs , breast area right side severe pain, and under right arm, neck severe pain, right arm severe pain down to tip of fingers, severe pain in left arm, hand, fingers, pain is nerve pain, then i have so much swelling it is cutting off circulation to hands, arms, whole right side of body and upper body on left side. head aches, exhaustion. I am a phone customer service representative and can not do my job right now because it hurts too much to type. I am on short term disability until the symptoms go away or get better. I am being treated with steroids, and tramadol for pain
48 2021-05-12 numbness and pain in extremities, feeling hot, discomfort, pain in extremity stiffness of joints; Didn't sleep at all last night.; Back pain; can't walk; Knee pain; right and le... Read more
stiffness of joints; Didn't sleep at all last night.; Back pain; can't walk; Knee pain; right and left arm pain/legs hurt/hands were also hurting; not as hard of a pain but it is in the muscles below the knee and in the back of the calf.; neuropathy; whip lash in shoulders and neck; feel radiation or heat; uncomfortable; shoulders became sore; tired; Eyes hurt; vasculitis pain flare up; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in right upper arm, at age 48 years, on 12Apr2021 13:00 (Batch/Lot Number: 9R8732) as second dose, single, for COVID-19 immunization. Relevant medical history includes two autoimmune diseases and two lung diseases further reported as ongoing Post-traumatic stress disorder (PTSD) diagnosed in 2017 because of trauma from vasculitis because both her arms looked like sleeves of nothing but broken blood vessels; Chronic obstructive pulmonary disease (COPD) from unspecified dates; ongoing bronchiolitis from unspecified date that does not go away; ongoing Hepatitis B contracted after vasculitis had gotten back together with her baby daddy and contracted it that way; ongoing small cell vasculitis (CSVV) from Oct2017 is her main disease; immune system weaker than her mom; body is weak; has weak muscles; generalized anxiety disorder; depression; she had fell on both arms, she's had a knee surgery; and she can barely walk because she pulled a back muscle before, her back and her having an injury from 2 years ago in 2019. Patient also usually gives blood at her primary care. Family history includes arthritis, her mom has it. Concomitant medications included tenofovir alafenamide fumarate (VEMLIDY) taken for antibiotic therapy from an unspecified start date and ongoing; meloxicam taken for joint swelling from an unspecified start date and ongoing; alprazolam (XANAX) taken for generalised anxiety disorder from an unspecified start date and ongoing; quetiapine fumarate (SEROQUEL) taken for post-traumatic stress disorder from an unspecified start date and ongoing; pantoprazole taken for ulcer from an unspecified start date and ongoing; sertraline taken for depression from an unspecified start date and ongoing; promethazine taken for prophylaxis of nausea and vomiting from an unspecified start date and ongoing; albuterol sulfate taken for an unspecified indication from an unspecified start date and ongoing; and budesonide taken for lung disorder, start and stop date were not reported. Patient historically took first dose of BNT162B2 (injection, Batch/lot number: EN6202) in the left upper arm at age 47 years on 19Mar2021 at 1:40pm at a clinic for COVID-19 immunization and experienced no adverse event; and an unspecified flu shot last Oct2020 (also reported as last winter). Patient has some 5 or 6 doctors there as specialists or prescribers. She has a liver specialist and a vasculitis specialist, whom she has not seen since the flare up because of her insurance, a main primary that saved her and brought her into remission is not covered with her insurance, and a GI doctor as well. She also reported that her immune system is probably weaker than her mom's because of her own 2 diseases. She also said that she was supposed to be in lung therapy but her body is weak. She stated that every time something hurts, it may be neuropathy. She has weak muscles and they haven't been this weak. She could move around and do things before. Patient was tired from the autoimmune and lung disease, she has had to stop and rest. Patient clarified that she had these prior to COVID coming. Patient wanted to get the vaccine to have more immunity so she could go out. She didn't want to get the Corona virus. The doctors said she wouldn't make it. It was her choice but the doctors recommended it. It was reported that patient has completed vaccination. About a week ago (13Apr2021), started experiencing a lot of pain from a vasculitis flare up. It is as if it just happened and was having a lot of pain in various parts of the body. Patient stated that it didn't start until like the second day (13Apr2021). Patient was not disgruntled, believes in the vaccine. She has an appointment with the tele doc this week and with another doctor at the same office since doctor was not in this week, because of her back and her having an injury from 2 years ago, X-rays, and can't walk right now, is in a lot of pain. She did not know if she can take pain pills, with all her other stuff. Patient stated that both her legs hurt and she can't walk. Her hands were also hurting with it in Apr2021. Patient had knee pain on 19Apr2021, leg pain was still there but getting better and was still hurting when she walks. It is not as hard of a pain but it is in the muscles below the knee and in the back of the calf in Apr2021. On 21Apr2021 or 22Apr2021, right and left arm just hurts all the way down started. They are the same and are still hurting and staying persistent. On 26Apr2021, back pain was added and stated that she got it for complaining about her arm. It started About 3 days after the shot, around 14Apr2021 or 15Apr2021, patient had whiplash in shoulders and the neck. It started in the back of the head and was like she could feel radiation or heat. It would be so uncomfortable, her shoulders became sore. When she looked left or right, it felt like whip lash. It has gotten better. For her arm, she wanted to revert to ice/heat but she hasn't done anything yet. Patient called her primary in hopes that he would give her something for the pain, she was not in pain management but it is hurting so bad. Since the injection, she has been so tired, so she has not been taking her XANAX. She takes them as needed for generalized anxiety disorder and her anxiety has not been up. A lot of the time she does not have to take them. The diseases make her tired and fatigued. If her mind is too racy, she will take to keep as calm as possible, especially with the small cell vasculitis or then she could have a flare. Her main objective is to keep calm. She was already taking 1 XANAX a day when diagnosed with PTSD but they just raised it because then came her PTSD and depression from the vasculitis. Has muscle relaxer cyclobenzaprine hydrochloride (FLEXERIL) at 100mg once a day which she doesn't take. Did not normally take these but has been taking them since this happened. She is in so much pain. Does not generally have high tolerance for pain. Does not like taking opioids because they make her throw up. She can only take them with Phenergan. Does not take if she does not need them because they do not sit well with the liver. She has an inhaler that keeps the lungs dilated for 10 hours, is not Pulmicort but something else. Eyes hurt on Apr2021 and can't read the label because its so little. She has bronchiolitis which is another rare disease with the airways in her lung and medication keeps the lungs dilated. Haven't seen the doctor yet so no tests yet. Since this happened, she can't walk. On 26Apr2021, when she went back down she couldn't walk since. It is her lower back on the right side, above her hip. She had pulled it 2 years ago (2019), above the hip on the right side. She recognized this feeling from a couple of years ago. It seems to be the place where she feels over winded. It may be neuropathy problems, wondering if it's not neuropathy since it's not her muscles (Apr2021). Everything that was wounded has come back and hurts as bad as it does. For can't walk, the pain just hurts. She didn't sleep at all last night (26Apr2021). Tries to turn and get up and if she is on either of her arms. Other than the neck, shoulders and back of her head, she never got a fever. When it started she thought that it was normal. Then, it started hitting in all of these other places and she was barely moving. Patient had the normal feeling like when she would breathe. On an unspecified date, she was having stiffness of the joints, as if they were traveling, then taking a vacation to every place that she has ever hurt itself. She had fell on both arms, she's had a knee surgery and its like going to that. The knee surgery was on the right knee. Like right now its in her back, and she can barely walk because she pulled a back muscle before. She stated that she will enjoy it if she can walk again and she just wanted to make it through this. The adverse events did not require emergency room visit or physician's office visit but was definitely at the point where she will go see the primary or go to the ER. The outcome of the event vasculitis pain flare up, right and left arm pain/legs hurt/hands were also hurting, and ?can't walk was not recovered; for knee pain, whip lash in shoulders and neck, feel radiation or heat, uncomfortable, and shoulders became sore, it was recovering at the time of report; for the other events, it was unknown. No follow-up attempts are needed. No further information is expected.
48 2021-05-12 pain in extremity Persistent pain in arm primarily at elbow and moving to forearm. Never had this time of issue before... Read more
Persistent pain in arm primarily at elbow and moving to forearm. Never had this time of issue before. Seems slightly swollen. Going to check with doctor for inflammation/bursitis.
48 2021-05-12 pain in extremity More than 24 hours after the vaccine, my arm was red, swollen, hot and painful. Less than 24 hours ... Read more
More than 24 hours after the vaccine, my arm was red, swollen, hot and painful. Less than 24 hours after the vaccine, my eyes began to become itchy. On the same morning I woke with the swollen, painful arm, my eyes were also swollen, red, itchy and painful. This required a visit to an urgent care facility. I was prescribed an oral steroid, antibiotic, and antihistamine as well as ice packs to be used on my injection site.
48 2021-05-12 tingling Pt was sitting in chair in the Observation area after waiting for approximately 30 minutes when she ... Read more
Pt was sitting in chair in the Observation area after waiting for approximately 30 minutes when she self reported tingling in face, arm, and tongue. Pt was moved to the gravity chair at the EMT station where she received water and 50mg of Diphenhydramine liquid oral solution. Pt self administered medication at 1310 and vital signs were taken every 5 minutes as patient was reassessed for any signs of respiratory distress. Vital signs 1505: BP 150/50 HR 72 RR 16 02 sat 99%. 1511: BP 145/75 HR 73 RR 16, 1515: BP 140/80 HR 64 02 97%, 1520: BP 140/70 HR 69 RR 16 02 98%, 1525 BP 132/75 HR 61 02 98%, 1532 BP 140/70 HR 66 RR 16 02 97%. Pt denied any SOB and reported relief from symptoms after taking oral medication. Pt vitals WNL throughout incident. Pt was able to communicate without any issues and make needs known throughout the incident. Emergency medical services (911) were offered to the patient; however, patient declined. Pt expressed wanting to go home and agreed to self administer allergy medication, Benadryl, for the remainder of the day. Informed the patient the need to go to the ER if symptoms worsened. Pt encouraged to sign up for VSafe upon leaving and to follow up with PCP.
48 2021-05-13 weakness, tremor low-grade fever; headache; body ache; dizzy; weak; queasy; chills; shaky; fatigue/tired another 24 h... Read more
low-grade fever; headache; body ache; dizzy; weak; queasy; chills; shaky; fatigue/tired another 24 hours/Third day still tired.; mild brain fog; higher fever 101.5+/couldn't get fever below 100.; This is a spontaneous report from a contactable other health care professional. A 48-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247) via an unspecified route of administration in right arm on 25Jan2021 11:30 as second dose, single for COVID-19 immunization. The patient previously received first dose on 04Jan2021 11:00, (lot number: EL0142) via an unspecified route of administration in right arm as first dose, single for COVID-19 immunization. Medical history included non-Hodgkins lymphoma from 1995, invasive ductal carcinoma 2009 with breast reconstruction; phrenic nerve paralysis left side; cardiomyopathy. Concomitant medications included metoprolol 100 mg, vitamin D [COLECALCIFEROL], beclometasone dipropionate (QVAR) 80 ug. No known allergies reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 (nasal swab, rapid test) post vaccination on 21Jan2021 test result was pending. On 25Jan2021 24:00, the patient experienced mild brain fog at 3pm; fatigue at 7pm; 11pm low-grade fever, headache, body aches; 4 am higher fever 101.5+, headache, body ache, dizzy, weak, queasy, chills, fatigue. Started ibuprofen and took every 4 hours and could not get fever below 100. Fever broke early hours the next day, but still was queasy, shaky, dizzy, achy and tired another 24 hours. Third day still tired. The patient received treatment for the events as OTC non-steroidal anti-inflammatory drugs. The events were non serious. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021007634 same patient/drug, different vaccine dose/event
48 2021-05-13 bell's palsy Bell's palsy.
48 2021-05-13 bell's palsy This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 01:00 (Batch/Lot Number: EW0164) (at the age of 48 years old) at 1st dose, single for COVID-19 immunization. Medical history included low iron, Bell's palsy in Jan2020 and patient had no known allergies. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications within 2 weeks of vaccination. On 25Apr2021 08:00 (after receiving the vaccine 2 days later), the patient had Bells Palsy symptoms started along with a head ache. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The outcome of the events was not recovered.
48 2021-05-13 cold sweat DIZZY AND CLAMMY-ANXIETY INDUCED.
48 2021-05-13 pain in extremity Vaccine - Monday 5/10/21 12:20 pm. Woke up shivering at 3 am 5/11/21. 104 fever by 7 am. BAD headac... Read more
Vaccine - Monday 5/10/21 12:20 pm. Woke up shivering at 3 am 5/11/21. 104 fever by 7 am. BAD headache ( vomited once). Chills, fatigue, sore arm and massive body aches. Fever dropped to 102 by afternoon but needed Advil/Tylenol around the clock . Immobile for 36 hours.
48 2021-05-14 feeling hot, tremor, weakness, difficulty speaking This is a spontaneous report received from a contactable consumer (patient) . A 48-year-old female ... Read more
This is a spontaneous report received from a contactable consumer (patient) . A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8735), in Arm Left on 21Apr2021 at 15:15 (at 48 years) at single dose for covid-19 immunisation. Medical history included urinary tract infection (UTI) and history of low blood pressure (not ongoing). She biked and hiked and eat healthy. Family history included high blood pressure in her dad and in her sister.Previously on 24Mar2021 (at 48 years) the patient received the first dose of the vaccine (lot ER8730) in right arm for covid-19 immunisation. Concomitant medication included ciprofloxacin taken for urinary tract infection from 10Apr2021 to 16Apr2021 (She just came off antibiotic a week prior to the second shot). On 21Apr2021 at 10:05 PM her heart rate was "extremely accelerated" (had accelerated heart rate) and patient stated that her chest, neck, and head felt "super hot" (her chest, neck, and head were hot) and also stated that she was feeling "weird" and "floaty". She stated these symptoms lasted about 15 seconds and went away but had another episode right after that she stated was "not as intense but pretty intense still."She had a couple of those situations and she kept getting a wave of like this floating feeling or sensation all over her body.She reported going to the emergency room (ER) on 21Apr2021 where she had a few more incidents like this and stated that she also got "real hot" and had a "sensation" all over her body all at once that she cannot describe (she states that it's different than a "pins and needles" feeling) that made her dizzy and caused her heart to race. She stated these symptoms continued for a couple of days. She reported that on 24Apr2021 she woke up and felt fine but on 24Apr2021 at night stated that the symptoms returned but worse, her muscles started "trembling and jerking" and reported having a hard time talking and walking; she got that all over sensation again all over her body, her heart was racing, her chest was tight and hot and her muscles were tremoring and her leg muscles started jerking and she had trouble talking and walking, her throat and neck were feeling tight and closing.She reported she took 2 Benadryl and drank some sugar 2 teaspoons of sugar water but her symptoms worsened so she went back to the ER. She stated that by the time she got to the emergency room, her symptoms had subsided except her legs were "still trembling"/ her legs were just shaky. At the ER they checked her heart and did a blood panel. They said everything was good, they sent her home. On 25Apr2021 and on 26Apr2021 she was dizzy, weak, shaky, and had other incidents of her heart racing that she stated weren't extreme and then started to feel better on 27Apr2021. She reported that on 27Apr2021 night she woke up and her chest was tight again, it was hot and tight on the left side, she had that floaty feeling again all over. She had left side chest pain from 23:00 until 5:40 in the morning then it stopped, everything stopped and she was fine all day.On 29Apr2021 afternoon she felt better but still had some slight dizziness "almost like vertigo" but on 29Apr2021 night she was back at the ER, she had that all over feeling again, that sensation all over, her leg muscles were jerking, she couldn't talk again, she took Benadryl and drank sugar water again because it worked before she really does not know if that was what worked but it calmed down after that the time before. She went back to the ER they checked her in and this time the sensation, the feeling that was all over stayed in the right arm and leg but it subside on left side, her heart was racing a couple more times. It was right when her legs muscles started tremoring, they were having minor jerks, not as bad but every time that happened her heart rate would go up, her resting was 59 or 61 and it got up to 101. Her neck and chest would get hot. On 29Apr2021 night she was in the ER for quite a while, it subsided they sent her home with some Ativan for tremors and palpitations and told her to follow up with a cardiologist. Patient went to the cardiologist, she had blood and labs done and she had 2 conferences on the phone with her doctor.On 30Apr2021 morning she was super dizzy and weak and shaky and light headed and nauseous. She went to a cardiologist on 30Apr2021 and has been hooked up to a 7 day heart monitor. She reported that she still felt "real trembly" she has started feeling a little dizzy and floaty feeling. Event accelerated heart rate was ongoing, it just popped up whenever on and off. Dizziness was ongoing, patient said it was on and off but it was more on than off; she said sometimes it was worse or it was less but it had never left. Chest pain recovered on 28Apr2021 at 05:40.Outcome of the other events was unknown.Events heart rate increased , feeling hot, floating sensation and dizziness are reported as serious per hospitalization in 2021.
48 2021-05-14 migraine 1.) Extreme arm soreness at site of injection. . .so sore I couldn't life my arm above my head - las... Read more
1.) Extreme arm soreness at site of injection. . .so sore I couldn't life my arm above my head - lasted 2 days. Started within a few hours of receiving the injection. 2.) Migraine headache which started the evening injection was received & lasted 2 days. 3.) Sensation & tenderness in my left underarm & left breast (same side of injection) noticed within the first hour of receiving the vaccine. 2 weeks post injection, I can still feel the sensation &this am worried about receiving the second vaccine this week.
48 2021-05-14 pain in extremity After first dose--slightly sore arm for 3 days.; This is a spontaneous report from a non-contactable... Read more
After first dose--slightly sore arm for 3 days.; This is a spontaneous report from a non-contactable non-healthcare professional. A 48-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: Unknown), via unspecified route on left arm on 19Jan2021 at 11:45 (at the age of 48 years) as 1st single dose for COVID-19 immunisation. The patient's medical history included allergies to freshwater prawns. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021, the patient experienced slightly sore arm for 3 days. The patient has not receive any treatment. The outcome of the event was recovered on 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-05-14 pain in extremity felling sick; fever; malaise; extreme nausea; throbbing of her arms and legs; dizziness; she started... Read more
felling sick; fever; malaise; extreme nausea; throbbing of her arms and legs; dizziness; she started hemorrhaging female wise; she started hemorrhaging female wise; This is a spontaneous report from a contactable consumer, the patient, and other contactable consumers. A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Er8735), via an unspecified route of administration in the left arm on 27Apr2021 at 12:45 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 in Dec2020 and was sick for 4 months, neutropenia, allergy to latex; until the virus in Dec2020, the patient would hemorrhage no less than 3 weeks and spotted always for 4 months since COVID-19. Concomitant medications included paracetamol (TYLENOL), ibuprofen (ADVIL 12 HOUR) and ethinylestradiol/levonorgestrel (PORTIA 21). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Er8732) on 31Mar2021 at 10:00 (at the age of 48-years-old) in the left arm for COVID-19 immunization and felt a little yucky. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took ciprofloxacin (CIPRO) and venlafaxine hydrochloride (EFFEXOR) and experienced allergies. On 29Apr2021 at 10:00 (also reported as 48 hours after the 2nd vaccination), the patient started gushing hemorrhaging female-wise. She described this as bleeding through her pads. Within a week in May2021, (also reported as a few days later), the patient experienced malaise, extreme nausea, throbbing of her arms and legs, and dizziness laying down. She said she felt really bad. She said she was rushed to the emergency room on 03May2021, and then again on 06May2021. The patient also reported feeling sick with fevers as of 04May2021 (also reported that she doesn't know when it started or ended) after the hospital, she was not able to make sense now. The patient was hospitalized for 3 days as of 06May2021 and was considering going back as she was feeling worse. At the hospital, the patient received fluids and antibiotics. The patient was treated with a supplement to slow the blood flow. She did not know if it was improving, persistent or worsening. For 3 days she could not take the supplement but started to bleed more yesterday (probably because she didn't take the supplement). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "she started hemorrhaging female wise", malaise, extreme nausea, throbbing of her arms and legs, dizziness, feeling sick and fever was not resolved.
48 2021-05-14 pain in extremity About 3 days after my vaccine, I started getting tinnitus, a high-pitched, cricket-like ringing in m... Read more
About 3 days after my vaccine, I started getting tinnitus, a high-pitched, cricket-like ringing in my left ear. It's been over 24 hours and hasn't gone away. I do also have pain in that ear, but that started the next day and may be due to my putting in earwax drops to try to loosen things up in there in case this was caused by wax. I did get other side effects not long after the vaccine, but they are "standard" expected ones, so I don't know if you need a report for them. I got a sore arm. Within a few hours of the vaccine, I was "spacey" (not thinking completely clearly, thinking slower and having difficulty concentrating). I was sleepy and lay down for about 45 minutes, but I'm not sure if I slept. I got the standard fever, chills, and muscle aches lasting about two or two and a half days after the vaccine. A little stomach upset on and off, but I get that normally. A little more nausea than usual, though.
48 2021-05-14 pain in extremity After second dose--slightly sore arm for one day; chills; slight body aches; slight headache; This i... Read more
After second dose--slightly sore arm for one day; chills; slight body aches; slight headache; This is a spontaneous report from a non-contactable non-healthcare professional. A 48-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left on 19Jan2021 at 11:45 as first single dose for covid-19 immunisation. after first dose patient had slightly sore arm for 3 days and second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left on 09Feb2021 at 12:30 as second single dose for covid-19 immunisation. Medical history included food allergy (allergies: freshwater prawns) and concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, not had the patient been tested for COVID-19. On 10Feb2021 at 08:00, the patient experienced after second dose slightly sore arm for one day, chills, slight body aches and slight headache. Patient was not treatment received for the adverse event. The outcome of the events was recovered o an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-05-15 burning sensation, discomfort The 1st episode was April 22nd (got 1st COVID vaccine dose April 16th - 6 days prior), the 2nd was M... Read more
The 1st episode was April 22nd (got 1st COVID vaccine dose April 16th - 6 days prior), the 2nd was May 13th (got 2nd COVID vaccine dose May 7th - 6 days prior). Both started in the evening around 8:30pm, around an hour after I?d finished eating. It started with a feeling of burning in the back of my throat that I thought was heartburn, so I took Tums. That didn?t seem to help, and it progressed to a feeling of burning at the back of my throat and down my esophagus as well as feeling like I had gas stuck stuck between my throat and stomach and needed to burp repeatedly. It was really uncomfortable to lie down ? that seemed to increase the discomfort and burning sensations, so I ended up basically walking laps for an hour plus and burping continuously till the pressure lessened enough that I finally felt like I could lie down. The second time in happened, I also ended up throwing up, which didn?t really seem to make me feel much better. About 30 min into each episode, I also developed a pretty intense headache around my temples, as well as a stuffy nose and eventually what felt like a sinus headache as well. After about 2 hours I was able to fall asleep and mostly slept through the night. I woke up feeling better, but still having some lingering symptoms - primarily the headache and a bit of a burning sensation in the back of my throat.
48 2021-05-15 burning sensation Burning sensation in back of head
48 2021-05-15 muscle spasms 3 days after my first shot I got my first period in 9+ months, despite being on hormone therapy that... Read more
3 days after my first shot I got my first period in 9+ months, despite being on hormone therapy that should have prevented it. I have also since had another very heavy period, lots of clotting and cramping lasting 7+ days. No need for doctor care but wanted to report this anomaly for scientific purposes.
48 2021-05-15 pain in extremity Bad body aches and fever- 36 hr. Ibuprofen Sore arm- ice ibuprofen still a little sore Bad dry eye ... Read more
Bad body aches and fever- 36 hr. Ibuprofen Sore arm- ice ibuprofen still a little sore Bad dry eye and mouth- 2 days after shot getting worse. Lots of liquids and lubricating eye drops.
48 2021-05-16 weakness Nausea started within 5to 10 minutes after vaccine, followed by dizziness and weakness. Blood pres... Read more
Nausea started within 5to 10 minutes after vaccine, followed by dizziness and weakness. Blood pressure 155. The staff gave me apple juice and ice to swallow to try to calm the effects. Went to Emergency Room hours later.
48 2021-05-16 numbness, pain in extremity Sore achy arm has developed with numbing feeling. At site of injection and down the arm and shoulder... Read more
Sore achy arm has developed with numbing feeling. At site of injection and down the arm and shoulder. It was a few days after injection and then came back. Very strange it?s weeks later.
48 2021-05-16 numbness About 15 min later, I noticed my right thumb was half numb. This persisted for about 2 weeks. I st... Read more
About 15 min later, I noticed my right thumb was half numb. This persisted for about 2 weeks. I still feel some numbness but only at the very tip of my thumb. It has now been six weeks.
48 2021-05-17 flushing heart rate increased; felt nauseous; flushed; This is a spontaneous report from a contactable consum... Read more
heart rate increased; felt nauseous; flushed; This is a spontaneous report from a contactable consumer. A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 12:00 (Batch/Lot Number: EL3247) as 1st dose, single for covid-19 immunization. The patient's medical history included rheumatoid arthritis, Hashimoto's Thyroiditis, allergies: Sulfa based drugs, shortlived anesthesia. There were no concomitant medications. The patient previously took codeine and experienced allergies, humira and experienced allergies. The patient experienced heart rate increased, felt nauseous, flushed on 26Jan2021 12:00 PM. The patient right after shot,her heart rate increased and she felt nauseous and very flushed. No treatment received for the adverse event. The Facility where the most recent COVID-19 vaccine was administered was Hospital.The patient underwent lab tests and procedures which included heart rate: increased on 26Jan2021 12:00 PM. The outcome of the events was recovered on unspecified date Follow-up attempts are completed. No further information is expected.
48 2021-05-17 migraine Severe migraine to the point of physical illness, vision impairment, vertigo. Symptoms are so sever... Read more
Severe migraine to the point of physical illness, vision impairment, vertigo. Symptoms are so severe my lifestyle is impacted as I cannot drive and unable to preform job duties or continue previous life style.
48 2021-05-17 pain in extremity, numbness Arm was really sore, it had heat in it. Tiredness, headache, and then I got numbness on my left toes... Read more
Arm was really sore, it had heat in it. Tiredness, headache, and then I got numbness on my left toes except my pinky toes. All my toes were numb, it was scary. Then on the sole of near my big toe was numb. I could feel pressure but no feeling. It was a couple of days with tiredness and headache but the numbness in the sole (palm part) of my foot and my toes wouldn't stop and I kept stomping my foot to try to get feeling in it. It's a bit better now but still not the feeling back. Sometimes I would feel even more of the numbness feeling and sometimes less of the numbness. But numbness never went away. I did have stress going on. On the 18th, I then had welts on my whole body. They were everywhere, they were welts and not hives. Under my chest, back and under my arms etc., welts. I took prednisone and Benadryl and I had my Epi-pen but the fact that I wasn't itching and it wasn't hives I decided not to take it. I kept taking those things but then I got scared because the welts weren't going away and my tongue was swelling. They told me I wasn't giving myself enough prednisone but my friend took me to urgent care on the 18th. My throat was itching and tongue was swelling and the welts traveled. It started with my upper body but by that time it had gone to my legs. The only thing I still have today is the numbness in my toes/foot.
48 2021-05-17 pain in extremity Left neck pain/ swelling . Started almost immediately after injection. Radiated from injection up to... Read more
Left neck pain/ swelling . Started almost immediately after injection. Radiated from injection up to shoulder, up to neck. Shoulder and arm pain went away after 3 days, however neck pain has continued daily since then
48 2021-05-17 tremor Palpitations and tremors of both hands followed by tingling of patient's tongue within 5 minutes of ... Read more
Palpitations and tremors of both hands followed by tingling of patient's tongue within 5 minutes of receiving the vaccine. Patient states her palpitations and tremors lasted about 15 minutes and spontaneously resolved. However, her tongue tingling lasted until she took Benadryl about an hour after onset of her symptoms. Patient denies tongue or lip swelling or throat tightening sensation.
48 2021-05-18 feeling hot acute diarrhea and it had been 16 days and it had not stopped. She has been going 7 to 10 times a da... Read more
acute diarrhea and it had been 16 days and it had not stopped. She has been going 7 to 10 times a day; Being dehydrated from having so many bowel movements; slight fever of 99.7 every night/She was still at 99.6, 99.7 so for the first few days it was over a 100/99 was a fever for her; Little bit of headache; ears got kind of hot; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 48 years of age), via an unspecified route of administration, administered in arm left on 19Apr2021 (Batch/Lot Number: ER8737) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included ongoing herpes simplex that has been going for years. Concomitant medication included aciclovir (ACYLO [ACICLOVIR]) taken for herpes simplex from an unspecified start date and ongoing. Historical vaccine included BNT162B2 dose 1 (Batch/Lot Number: ER8732) on 29Mar2021 in the left arm for COVID-19 immunisation. The patient got her second Pfizer vaccine on April 19th as soon as she got her shot, her ears got kind of hot and then she has had acute diarrhea and it had been 16 days and it had not stopped. She has been going 7 to 10 times a day. She was still running a slight fever of 99.7 every night and her doctor was, they have been trying everything they can to stop the diarrhea. Just a little bit of headache but she does not know if the headaches are from being dehydrated from having so many bowel movements, so with the headaches, so they cannot stop it. Her doctors have her on three medications, one of them was an antibiotic, one of them was Imodium (later confirmed as loperamide) just a few things and the other one was a muscle contractor in the GI tract trying to stop her muscles from spasming and he tested her for every parasite, every bacterial, everything, did a CAT scan, everything was coming back negative. She confirmed that she got the symptoms the very next day, so 20Apr2021 was the day that she started all her symptoms. So, still current. She was still at 99.6, 99.7 so for the first few days it was over a 100, so it did go down after the first 2 days but then after that it just stayed at 99. She mentioned that her temp usually runs at 96, so 99 was a fever for her. She added that she went to the hospital 2 times. In 2 different times because she got IV fluid. The first one was on 23Apr2021, the second time she went was on 03May2021. She confirmed that she went to the hospital for treatment and no hospitalization was done. She added that she was treated then was released, she was given fluid through an IV and then they released her, because all the diarrhea was making her dehydrated because she was losing so much. She did not get admitted, she just went in and was treated and released. She was tested for bacterial, parasite, HIV, Hep C, gonorrhea, chlamydia, STD everything. Everything they tested her was coming back negative. They also did CAT scan, they have done everything, but cannot figure out why the diarrhea won't stop, they have put her on all those stuffs, and nothing was working. She asked what she should do to stop the diarrhea. Therapeutic measures were taken as a result of the events. For diarrhea she was given antibiotic Vancomycin 250 mg three times a day for 10 day from 29Apr2021 and was still using; loperamide 2 mg four times a day from 23Apr2021 and was still using; and the next one was just put her on because she had to go back to the hospital the other day was dicyclomine 20 mg, four times a day from 3May2021 and ongoing. She was also given with Benadryl through an IV at the hospital and they also gave her a medicine to stop that 'poison reaction' (not clarified further), and then they have her scheduled with a GI specialist too. There was another name of the medicine that they treated her at the hospital, they said she was having a reaction, so they gave her atropine and then they put Benadryl, they gave her that at the ER on 23Apr2021. Also, they give her a COVID test and that was negative too at the hospital on the 23Apr2021. The outcome of the events was not recovered. Information about Batch/Lot number available. Additional information has been requested.
48 2021-05-18 seizure had multiple seizures over a few day; This is a spontaneous report from a contactable (patient) via ... Read more
had multiple seizures over a few day; This is a spontaneous report from a contactable (patient) via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A non-pregnant 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 23Apr2021 at 10:45 AM (Lot Number: Ewo172), at the age of 48 years, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 The patient had prior history of epilepsy, petit mal seizures. None for the last 20 years. The patient did not receive any other medication within 2 weeks of vaccination Past drug events included penicillin [benzylpenicillin], ampicillin, amoxicillin, clindamycin, vancomycin. The patient reported that on 27Apr2021 at 08:30, four days after vaccine she had multiple seizures over a few days. No treatment was given for the event. The clinical outcome of the event was recovered. She reported "I am now seizure free again". It was also reported that since the vaccination, the patient had not been tested for COVID-19.
48 2021-05-19 feeling hot, pain in extremity huge blood clot in her neck and a huge one in her left arm; her arm had swollen up at the elbow and ... Read more
huge blood clot in her neck and a huge one in her left arm; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 07May2021 (received at 48-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included fibromyalgia, colon cancer/postchemo from 2018, APS (antiphospholipid syndrome), arthritis and allergy to sulfa drugs. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. She was not pregnant. Concomitant medication(s) included pregabalin (LYRICA) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; oxybutynin (OXYBUTYNIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VIT B12) taken for an unspecified indication, start and stop date were not reported. Past drug history included known allergies to naproxen and oxycodone. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EW0161), administered in Arm Right on 16Apr2021 12:00 for COVID-19 immunisation. The patient got her second dose of the Pfizer vaccine on Friday, 07May2021. By Monday evening, 10May2021, her arm had swollen up at the elbow and was red, painful and warm to the touch. After appointment she had on Tuesday, 11May2021, she went to the ER (emergency room) as it had gotten worse and confirmed she has a huge blood clot in her neck and a huge one in her left arm. She was put on permanent blood thinners after following up with my PCP (primary care physician). The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). As corrective treatment, the patient received Lovenox, Wafarin, Zarelto. Outcome of the events was recovered with sequelae on an unspecified date in May2021. The adverse events were assessed as life-threatening.
48 2021-05-19 hypersensitivity of all senses Feels like I have the flu. Body aches and hurts to the touch, huge headache
48 2021-05-19 numbness, tingling Numbness/tingling in my ring and pinky finger in the left hand. It started just a few hours after m... Read more
Numbness/tingling in my ring and pinky finger in the left hand. It started just a few hours after my first vaccine and has remained persistent since that time. Some days it can be more prominent than others but has generally remained consistent since the time of the vaccine.
48 2021-05-19 numbness Nearly exactly 2 weeks after my second dose, I've begun to have muscle and joint stiffness in my leg... Read more
Nearly exactly 2 weeks after my second dose, I've begun to have muscle and joint stiffness in my legs and hands. My feet and hands feel numb at times and it feels as if I'm retaining water or swollen. My ankles, knees, leg muscles, wrists, hands and fingers are encountering this. I've never had this issue before in my entire life.
48 2021-05-19 nerve pain cellulitis; infection; pain seemed to spread to my inner elbow area / It was intense pain; pain seem... Read more
cellulitis; infection; pain seemed to spread to my inner elbow area / It was intense pain; pain seemed to spread to my inner elbow area / It was intense pain; skin became red; skin became red and swollen; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0172), via an unspecified route of administration in the left arm on 29Apr2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), chronic constipation, silent reflux, allergies to several antibiotics and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN), omeprazole, magnesium citrate. The patient previously took doxycycline, clarithromycin (MACROBID), and erythromycin and experienced allergies to all. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 07Apr2021 (at the age of 48-years-old) for COVID-19 immunisation and experienced pain (like nerve pain) on the interior side of the upper arm that went from the elbow up to almost the underarm area about 10 days after the first shot (there was nothing visible, just pain). The patient did not receive any other vaccines within 4 weeks of the vaccination. At the time of the second vaccination, the patient still had ongoing pain (like nerve pain) on the interior side of the upper arm that went from the elbow up to almost the underarm area, which she experienced 10 days after the first vaccination on 17Apr2021. On 02May2021, after the second vaccination, the pain seemed to spread to the inner elbow area, and it was intense pain. The skin became red and swollen and in that one location. The patient visited the doctor on 03May2021, and he was not sure if it was cellulitis or another type of infection, and prescribed antibiotics, cefdinir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of cellulitis, infection, "pain seemed to spread to my inner elbow area / It was intense pain", skin became red and swollen was not resolved.
48 2021-05-19 night sweats, hot flush Following the first vaccine I felt flu like for over a week then I had a 16 day long cycle. I have n... Read more
Following the first vaccine I felt flu like for over a week then I had a 16 day long cycle. I have not had a cycle longer than two days for over 5 years. I continued to feel exhausted and sick but it was tolerable until the second vaccine. After that one I have dizziness, nausea, headaches, no appetite, insomnia, horrible night sweats, stinky sweat, chest pain, hot flashes, can't think straight, high glucose, and swollen glands in my neck.
48 2021-05-19 pain in extremity arrhythmia; chest pain; felt like she had the flu; Body aches; fever; fatigue; arm began hurting; sh... Read more
arrhythmia; chest pain; felt like she had the flu; Body aches; fever; fatigue; arm began hurting; short of breath; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 20Apr2021 16:45 (Batch/Lot Number: ER8732) as 2nd dose, single for covid-19 immunisation. The first dose was received on 29Mar2021(lot number: ER8730) on the left arm, and experienced sore arm and tired. Medical history included ongoing outbreaks on lips. Concomitant medication(s) included valacyclovir. Patient went to the emergency room on 21Apr2021 with chest pain that started on 20Apr2021. She was put through tests and the medical staff didn't know what was wrong and was discharged on 22Apr2021 and went back to the emergency room with chest pain on Friday, 23Apr2021. The medical staff could not figure out what was causing her chest pain during the second emergency room trip. Patient reported that the arrhythmia occurred when she got the chest pain on 20Apr2021. If she does any sort of activity, her heart rate skyrockets and her heart beats really super fast. She will become totally short of breath and feel like her lungs were burning. She experiences the arrhythmia and shortness off breath not even with exercise, but just activity within the house. On 21Apr2021, patient had a fever, body aches, and felt like she had the flu for 3 days following the second dose of the Covid-19 vaccine. She went back to the emergency room again at a different hospital on Thursday, 29Apr2021 until 30Apr2021. She was going to see a cardiologist this on 07May2021 because she can't do anything. Her chest pain didn't start off this way, but now the patient can't be active without having chest pain, arrhythmia, feeling like something is sitting on her chest, and shortness of breath.The chest pain was initially brought on by exercise, but as of time of report, if she moves around or does too much, the chest pain will be brought on. Symptoms have changed a bit as time has gone by. If she sits still not doing anything, she will be fine. If she takes a shower, walks around her house, walks upstairs, she will experience the chest pain, shortness of breath, and feeling like something is sitting on her chest. If she does absolutely nothing like an invalid, she's ok. Event chest pain resulted in physician's office visit. Patient had EKGs (21Apr2021, 22Apr2021, 23Apr2021, 29Apr2021 and 30Apr2021), a stress test (22Apr2021), CT of the chest (21Apr2021), CT of the heart and arteries on (30Apr2021), X-rays, and echocardiograms (22Apr2021 and 29Apr2021) which were all of the diagnostic tests have come back normal. There was no way that she could do a stress test now. Her fatigue began the day after she received the second dose of the Covid-19 vaccine on 21Apr2021. Fatigue was the most intense the first couple of days when she felt like she couldn't get out of bed but she still gets tired very easily. It was worse in the sense that now she has no fever and yet still can't function normally. Her arm began hurting on 20Apr2021 and was sore for about a week. Patient had covid-19 screening on Apr2021: negative. Outcome of the events of arrhythmia, chest pain, shortness of breath and fatigue was not recovered, while for the remaining events was recovered.
48 2021-05-19 tremor, tingling Patient complained of tingling all over the body and shakiness. 30 observation performed. VS BP 14... Read more
Patient complained of tingling all over the body and shakiness. 30 observation performed. VS BP 148/70, P 80, O2Sat 98%. Patient verbalized relief of symptoms after sit down calmly and performed deep breathing.
48 2021-05-20 flushing pt got 1st covid vaccine on 5/4/21 and developed swallowing difficulites. Felt flushed and had a so... Read more
pt got 1st covid vaccine on 5/4/21 and developed swallowing difficulites. Felt flushed and had a sore throat. Complained of swelling in throat. Pt taken to ED. 48-year-old female presents from vaccine clinic with concerns about possible allergic reaction. No urticaria, no wheezing, no angioedema. Does have occasional bronchospastic cough. Patient reports she gets this with involved but felt a little bit of throat tightening and was worried she could be having an allergic reaction. Received Benadryl and Decadron here, reports that she would like to go home at this point in time, does not want to try albuterol that was ordered, will take over-the-counter allergy medicine as needed and return for any worsening. Unclear if this is truly an allergic reaction, patient advised that she still should get the second shot and be monitored closely.
48 2021-05-20 numbness, muscle twitching 1. My entire face went a little numb. From the top of my forehead to under my chin (not neck) left ... Read more
1. My entire face went a little numb. From the top of my forehead to under my chin (not neck) left and right side of my face , equally numb allover face. Could still feel, not paralyzed, but definitely partially numb. Started 25 mins after shot. Lasted about 3 hours. 2. Left eye twitching. Started about 25 mins after shot (along with the face numbness) Only left eye. Would twitch intensely for 2-3 seconds, approximately every 20 minutes. This lasted for 9 days, then subsided for 3 days until stopped completely. 3. Very mild, strange feeling washed over me approximately 5 seconds after the shot. It subsided after maybe 20 minutes. 4. Weird taste appeared in mouth about 30 seconds after shot. Lasted only a few minutes. 5. Achy, headache, 101 temperature. Started 8 hours after shot. lasted for 3 days.
48 2021-05-20 pain in extremity Pain left arm,fever after 24 hrs fatigue,blotting and diarrhea x 2 days
48 2021-05-21 inability to speak, pain in extremity Tunnel vision, hearing sounded like underwater and almost passed out....couldn't verbally respond wh... Read more
Tunnel vision, hearing sounded like underwater and almost passed out....couldn't verbally respond when my husband asked me a question for a short time. Fever, chills, sick to my stomach, dizzy, headache, sore arm, and excessive tiredness.
48 2021-05-21 slurring Per patient, had reaction to 1st dose but was cleared by allergist. Developed itching of tongue/thro... Read more
Per patient, had reaction to 1st dose but was cleared by allergist. Developed itching of tongue/throat, tightness of throat and difficulty speaking. Interventions: Benadryl 50 mg. Epi 0,3. Vital signs : BP=139/96 B.P = 175/112 Patient Transported to hospital via ambulance at 11:02 A.M. Recorded by HCP. Evaluated and treated by HCP
48 2021-05-21 pain in extremity Prolonged menstrual cycle- 11 day flow Headache Body aches Sore arm Fatigue
48 2021-05-21 tingling, pain in extremity The tool has timed out on me 2x already, so I dont have time to give you great detail like I did the... Read more
The tool has timed out on me 2x already, so I dont have time to give you great detail like I did the first 2x! Severe adverse include TMJ (right side) and severe rotator cuff tendon pain (left side) Symptoms include: Jaw - Cannot open my mouth more than 2 fingers. 10/10 pain. Headache, neck pain, tingling right side of my face and head. Arm - cannot raise my arm higher than shoulder length without severe pain.
48 2021-05-22 pain in extremity inflamed arm for 5 days
48 2021-05-22 speech disorder, muscle spasms, tremor About 18 hours after my second shot, I was suddenly and severely slammed with extreme pain, shaking,... Read more
About 18 hours after my second shot, I was suddenly and severely slammed with extreme pain, shaking, trembling, spasms, inability to talk or breathe easily... My body shook uncontrollably and every inch of me was in severe pain. I crashed and slept for3 or so hours. The SHAKING was uncontrollable tremors and pain.
48 2021-05-22 unresponsive to stimuli Around 2:00pm, I was feeling tired. I went home to take a nap. Upon arriving at home,, I started t... Read more
Around 2:00pm, I was feeling tired. I went home to take a nap. Upon arriving at home,, I started to feel light headed and the room began to spine,. I realized I was about to pass out. I made my last call to my daughter for help. When she came home I was unresponsive. She called 911 and started doing what the 911 operator was instructing her to do. I came to for a few seconds and pasted out again. I woke up with my sister pounding my chest area. I passed out again and work to EMTs asking me questions. I lost my bodily function when I passed out. On the way to the ambulance, I began to throw up. I passed out again and woke up on February 14. I say up work because I have no recollection of what happened to me after I got in the ambulance. I was taken to Hospital. They ran all types of tests. I know my heart was elevated. I ended up leaving the hospital on dialysis and a implanted defibrillator. I have 1342 pages of medical records that I can share.
48 2021-05-23 bell's palsy bells palsy
48 2021-05-23 numbness and pain in extremities Nausea/vomiting for 24 hours after shot, muscle/joint pain for 3 days after shot, bilateral hand neu... Read more
Nausea/vomiting for 24 hours after shot, muscle/joint pain for 3 days after shot, bilateral hand neuropathy (continuing) since 2 hours after first shot.
48 2021-05-23 tremor Complained of tightness in throat and chest, heart racing, anxiety after vaccine. Went to Urgent c... Read more
Complained of tightness in throat and chest, heart racing, anxiety after vaccine. Went to Urgent care and was seen by PA-C. Patient was given a Benadryl shot with a weird panic attack noted before she received it. Legs shaking and couldn't stand. Felt better after she received the shot/
48 2021-05-24 facial paralysis, numbness, mild one side paralysis, severe one side paralysis On 5/20 patient started experiencing right arm and leg weakness, accompanied by right sided facial n... Read more
On 5/20 patient started experiencing right arm and leg weakness, accompanied by right sided facial numbness and facial droop. She was taken to the ER and admitted to the hospital for right sided hemiplegia and left sided frontal lobe stroke per MRI. No signs of atrial fibrillation. Hospital notes indicate that etiology of stroke is unclear.
48 2021-05-24 muscle spasms menses cycle has stopped/no menses; Pelvic area cramping; This is a spontaneous report from a contac... Read more
menses cycle has stopped/no menses; Pelvic area cramping; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: eld142) intramuscularly administered into left arm on 05Jan2021 00:00 (also reported as 12 AM; at the age of 48-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included latex allergy and 4-5 day heavy cycle every 22- 28 days. Patient was not pregnant. The patient's concomitant medications were not reported. It was reported that on Jan2021 patient's menses cycle has stopped, she had no menses and experienced pelvic area cramping. The patient did not receive any treatment. It was reported that the patient will have an OBGYN appointment next week to check estridiol, FSH and LH as well as antiovarian and anti thyroid to see if vaccine triggered an autoimmune response. Outcome of events was not recovered. Follow-up attempts completed. No further information expected.
48 2021-05-24 pain in extremity 48 y/o female with past medical history of Ovarian Cyst and Menopause who presents with dizziness an... Read more
48 y/o female with past medical history of Ovarian Cyst and Menopause who presents with dizziness and sweating post vaccination. Patient states that this is her 2nd vaccination in the two-dose series. Patient states that after the first vaccination the only reaction she had was a sore left arm, that remains. Patient received todays vaccination to the left arm. Patient states prior to arrival she had a headache and took Tylenol x2. NP and Paramedics at patient side. Patient provided bottle of water and placed in Trendelenburg. Patient vitals within normal limits, 135/82 BP, 74 HR, 98%RA, Resp 12, Glucose 135 (mildly elevated either due to stress or eating a big breakfast per patient). Within 5 minutes patient with resolution of symptoms. Patient states that she no longer feels dizzy and sweating has resolved. Patient vitals upon discharge also within normal limits. Patient aware that if symptoms worsen or persist to seek further medical care. Patient discharged home in stable condition.
48 2021-05-25 weakness, pain in extremity, migraine, numbness migraine , blurry vision,drop foot,leg pain, Concentration problems, numbness, weakness, all still e... Read more
migraine , blurry vision,drop foot,leg pain, Concentration problems, numbness, weakness, all still effecting me
48 2021-05-25 flushing Per patient. This is a 48 year old female with no relevant PMH who presents to the ED for evaluation... Read more
Per patient. This is a 48 year old female with no relevant PMH who presents to the ED for evaluation of chest pain and palpitations after COVID 19 vaccination. The patient reports that approximately at 8:45 AM she received the first shot of the Pfizer coronavirus vaccine. Within 15 minutes she began to develop palpitations a flushed feeling, tickling in the back of her throat. There is no itching or rash. There is no difficulty handling secretions. The patient has never had an adverse reaction to vaccine in the past. Her only allergy is of ibuprofen, which causes hives. Patient reports ongoing palpitations since this started. No difficulty handling secretions. No leg swelling. No hx of cardiac disease.
48 2021-05-25 numbness Patient states about 1 hour after receiving pfizer Covid-19 vaccine she had left-sided facial swell... Read more
Patient states about 1 hour after receiving pfizer Covid-19 vaccine she had left-sided facial swelling and a numbing sensation of the face along with lip swelling . she complains of Left upper extremity and injection site pain .
48 2021-05-25 migraine, muscle spasms, nerve pain Immediate extreme migraine; Severe neuralgia flare up; Can't sleep due to muscle pain; Can't sleep d... Read more
Immediate extreme migraine; Severe neuralgia flare up; Can't sleep due to muscle pain; Can't sleep due to muscle pain; Breakthrough bleeding; Cramps; 1st dose : 15Apr2021, 2nd dose: 15Apr2021; 1st dose : 15Apr2021, 2nd dose: 15Apr2021; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 15Apr2021 09:30 (Batch/Lot Number: ER8735) as 1st dose, single, and via an unspecified route of administration, administered in right arm on 15Apr2021 (Batch/Lot Number: EW0176) as 2nd dose, single for COVID-19 immunization, in an urgent care center. Medical history included chronic migraine, occipital neuralgia, and Penicillin allergy from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL); and zonisamide, both taken for an unspecified indication. On 07May2021, the patient experienced immediate extreme migraine, severe neuralgia flare up, she can't sleep due to muscle pain, breakthrough bleeding, and cramps. The patient has not recovered from the events.
48 2021-05-26 weakness injection site soreness; Chills; Weakness; Headache; This is a spontaneous report from a contactable... Read more
injection site soreness; Chills; Weakness; Headache; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264; Expiration Date: Sep2021), via an unspecified route of administration on 03Feb2021 at 12:05 (at the age of 48-year-old) as 2nd dose, single, in left arm for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus which was diagnosed probably more than 10 years, hypertension for which she was taking high blood pressure medication for 5-6 years and sleep apnoea syndrome. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982), via an unspecified route of administration on 13Jan2021, as single dose for COVID-19 immunization. On 03Feb2021, the patient experienced headache. On 04Feb2021 at 07:30, she experienced chills and weakness. Patient had a headache prior to getting her second dose of the vaccine, as she had issues with her sinuses, so she took medicine before getting the vaccine because she assumed it was sinuses. There was no further details provided about medication she took for her sinuses. After the vaccine she had injection site soreness, and had a headache, chills, and weakness, which she knew it was common symptom of vaccine. Patient took Tylenol prior to the shot, so the soreness to injection site was minimal. The patient underwent lab tests and procedures which included blood cholesterol: normal, blood glucose abnormal: normal, blood pressure measurement: normal. The clinical outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
48 2021-05-26 pain in extremity, numbness +10 mins, strange taste in mouth, excess saliva +25 mins, numbness in lower half of face and lips, t... Read more
+10 mins, strange taste in mouth, excess saliva +25 mins, numbness in lower half of face and lips, twinge/cramp feeling in heart area +30 mins, sinus clearing and drainage (still continuing 5 hours later) +45 mins, itching under left side of tongue in thin line from base to tip, might be a nerve, arm getting sore +1 hr, gastro symptoms started, unusual feeling in intestines +2 hr, fatigue, tiredness +5 hr, chills +8 hr, dizziness +9 hr fatigue, tiredness +12 hr lower back pain and tenderness in kidney area, both sides +15 hr severe fatigue, tiredness, arm soreness/pain, other muscle pain +24 hr arm soreness, fatigue, tiredness +25-29 hr severe fatigue, tiredness, fever, couldn?t stay awake +54 hr severe fatigue, tiredness, fever, couldn?t stay awake Days 1-5: gastro system upset, nausea, diarrhea
48 2021-05-26 pain in extremity, tremor feeling tired/excessively tired; left arm was shaking a lot/left arm was shaky like a heartbeat; kno... Read more
feeling tired/excessively tired; left arm was shaking a lot/left arm was shaky like a heartbeat; knocked her out; sleepy; her left arm was sore/still had some left arm pain; excessive, bad diarrhea; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female consumer patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170) via an unspecified route of administration, in arm left, on 07May2021 15:00 (at the age of 48-year-old) as single dose for COVID-19 immunization. Medical history included ongoing migraine; patient had another allergic reaction but she wasn't sure what it was from. Her forehead got swollen and she had hives all over her body. It wasn't from medication. Her friend had traveled overseas and brought back Arabian candy and she ate a piece of the candy. Within 20 minutes of eating the candy her eyes started to get itchy and the hives started. Concomitant medication included migraine medicine when she needed but she did not get a migraine with the Covid 19 vaccines and patient declined to provide the name of the medication. The patient previously had allergy to cefalexin (KEFLEX), she got really bad diarrhea when she took cefalexin (happened about 3 or 4 years ago). The patient previous receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), in arm left, on 16Apr2021 14:00 (at the age of 48-year-old) as single dose for COVID-19 immunization, then it was the next day she noticed, on 17Apr2021, her tiredness and her arm soreness, the arm soreness only lasted about 2 days, and the tiredness only lasted for a day. Patient received her second vaccine on 07May2021. She felt ok the day she got the vaccine but the following day (08May2021), she was sleepy and her left arm was sore and she thought that was normal. Then Saturday night, 08May2021, she got really excessive, bad diarrhea. She thought maybe that's part of the vaccine maybe it wasn't. The diarrhea continued into Sunday morning, 09May2021 and she called the appointment center for her primary care doctor. Her arm was sore, she was still feeling tired and her left arm was shaking a lot. She asked the appointment center to notify her doctor. She was supposed to work Sunday night, 09May2021, and she needed a work note. She had been leaving messages at her doctor's office and no one was returning her calls. She was wanting to know if someone here at Pfizer could help her. She received the second Covid 19 vaccine on 07May2021 and the second Covid-19 vaccine hit her more and knocked her out the following day (08May2021). She was really excessively tired and her left arm was really sore. When she got up she was resting her arm and her left arm was shaky like a heartbeat. She still had some left arm pain but it's improved. Her left arm shaking lasted for about a day and a half. No AE require a visit to emergency room and physician office. No prior vaccinations (within 4 weeks). The outcome of the event "her left arm was sore/still had some left arm pain" was recovering, of other events was unknown.
48 2021-05-26 tenderness Not sure it's related to the shot. Three weeks after the second shot I started experiencing progres... Read more
Not sure it's related to the shot. Three weeks after the second shot I started experiencing progressively increasing pain in the left shoulder joint. After each dose the same joint ached but the pain resided after approximately 24 hours. The area is painful to the touch but not hot or red. For 5 days to date I have treated the area with hot compresses with minimal results. For 3 days to date I receive some relief treating the area with voltaren cream (not prescribed for this). Today I began castor oil packs but have not seen any change in pain at this point.
48 2021-05-27 seizure, involuntary muscle movements The patient let us know that she had had a seizure after the first COVID shot and that she has them ... Read more
The patient let us know that she had had a seizure after the first COVID shot and that she has them after every vaccine. This has happened since she was a little girl. The patient was visibly nervous before the vaccine was administered. During her observation time following the vaccine administration, she let provider know that she could feel her left arm tightening up. Provider provided the patient with an ice pack for her neck to try to calm her down. The patient asked for us to not call a rapid response yet and that "I'm trying to calm myself down." observed the patient's left hand starting to grasp and the patient became tearful so asked the patient if she was okay. The patient stated she was okay. Provider asked her to let her know if she felt like she was going to have a seizure. About a minute later, the patient let provider know she felt one coming. Provider called the RRT as the clinic Team Lead, let the patient know she was going to recline her in the chair she had been vaccinated in. Seconds after the chair was reclined, the patient's eyes started to roll back in her head and her eyelids started to flutter. Within about 10 seconds, the patient was jerking up and down in the chair. The clinic staff ensured the patient was safe until the arrival of the RRT. As the RRT arrived, the patient's seizure ended. The patient became alert to talk to the team that arrived to the clinic. She refused being seen by the ED. The clinic staff agreed to monitor her vitals until she felt comfortable to leave. After around 30 minutes after the seizure, the patient was in good spirits and stated she would like to stand and see how she felt. The patient stood up and walked around for a moment before saying she was ready to leave. Provider checked the patient out, and she left the clinic.
48 2021-05-28 migraine I have had 4 severe migraine headaches with vomiting since getting my first Covid vaccine. Two of th... Read more
I have had 4 severe migraine headaches with vomiting since getting my first Covid vaccine. Two of the four required trips to urgent care for IV treatments. I had not had 4 migraines total in the 25 years prior to getting the vaccine.
48 2021-05-28 pain in extremity, feeling hot my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm bec... Read more
my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; my arm became hot, red, swollen and painful; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; have swollen, painful and itchy eyes; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172 and expiration date not provided), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 17:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history included hypothyroidism and Anemia. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included levothyroxine, ferrous sulfate, fluticasone propionate (FLONASE ALLERGY RELIEF), and ibuprofen. On 12May2021 05:30, the patient experienced arm became hot, red, swollen and painful. The patient also have swollen, painful and itchy eyes. The events cause the patient for emergency room visit. The events were treated with Oral steroid, antibiotic, antihistamine. The outcome of the events was not recovered.
48 2021-05-28 pain in extremity Headache; Sore arm; This is a Spontaneous report from a non-contactable consumer (patient). A 48-yea... Read more
Headache; Sore arm; This is a Spontaneous report from a non-contactable consumer (patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, Lot number: EN6199, Expiration date: 05Mar2021), via an unspecified route in the left arm on 05Mar2021 at 15:45, as a single dose for Covid-19 immunization. Medical history included diabetes. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks. The patient did not take any medications within two weeks. Since the vaccination, the patient had not been tested for COVID-19. The patient had not been tested for COVID-19 post vaccination.On 06Mar2021 at 09:00, patient experienced headache and sore arm. The clinical outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained
48 2021-05-28 pain in extremity Sore arm Breast tenderness and swelling for 2 days followed by menstrual spotting at day 11 of my cy... Read more
Sore arm Breast tenderness and swelling for 2 days followed by menstrual spotting at day 11 of my cycle. I am always 27-29 days. This has never happened before. Why would a vaccine impact a women?s mental cycle? I am very concerned.
48 2021-05-31 migraine, pain in extremity Migraine onset 5/20 and lasting each day until 5/28/2021. Some days worse than others. Extreme fati... Read more
Migraine onset 5/20 and lasting each day until 5/28/2021. Some days worse than others. Extreme fatigue 5/21/2021 throughout the day and evening (I had three naps and went to bed around 7 PM until 7 AM the next day)! Neck and arm pain lasting 5/20 - 5/24/2021 (tightness, soreness, pain) slight loss of appetite
48 2021-05-31 pain in extremity Sore arm for a few days; This is a spontaneous report from a contactable consumer (patient) reportin... Read more
Sore arm for a few days; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 48-year-old non-pregnant (at the vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EN 5318 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm right on 28Jan2021 at 16:45 as 1st dose, single, and dose 2 via an unspecified route of administration, administered in arm right on 18Feb2021 (lot number was EN 5318 and expiration date was not reported) as 2nd dose, single for COVID-19 immunisation. The patient medical history included attention deficit hyperactivity disorder (ADD) and the patient did not have known allergies. The patient concomitant medications included amfetamine aspattate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), escitalopram oxalate (LEXAPRO), and amlodipine. The patient had not COVID prior vaccination. The patient did not receive other vaccine in four weeks. It was reported that, on 29Jan2021 at 21:00 the patient experienced sore arm for a few days. The patient reported that this was the only reaction she experienced from the vaccine. It occurred approximately 8 hours after receiving the shot and subsided completely approximately 48-60 hours later. The patient did not receive treatment for the event. It was confirmed that the 1st shot was on 28Jan2021, but sore arm occurred next day 29Jan2021. The patient was not COVID tested post vaccination. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-05-31 tingling She got her vaccine, they had her wait an additional 15 minutes. She had tingling sensation the en... Read more
She got her vaccine, they had her wait an additional 15 minutes. She had tingling sensation the entire time and she went home. Around 5:27 she looked at her arm, it was bruised, it felt like alligator skin, rough to touch when she touched it and started to get little blisters around it. It looks like her skin is burnt like she had been in a fire. She went to the Medical Center and they told her that it was a local reaction and outlined it with a marker, and gave her an ice pack, which seemed to make it worse. They gave her Naproxen and then she decided to leave as they didn't do anything, and said that she said it was a local reaction and that was going to get the second vaccine. She went home so on 5/20/21 she went to Hospital. She saw DO in the ER. She had chest pain, shortness of breath and two very large blisters on her arm with fluid in it when she was seen there. She was informed that whoever gave her the vaccine did not go in far enough and that they gave her the vaccine in the tissue and not the muscle. They did EKG, and they did blood work to see that it was no blood clots or in her lymph nodes, and said that it was a severe reaction from the vaccination, and that they had never seen anything like that before. 0n 5/21/21 she went to her PCP, she drained the numerous blisters that she had on her arm, she prescribed her Clindamycin, Motrin 600 mg, a skin cream Kenalog, she also gave her some aquaphor cream as well. She does not feel that this has helped much. Even after she drained the blisters, which the fluid was clear. She has been taking numerous pictures. The blisters came back, not as large but came back. The blisters would drain when she would take a shower and it was tannish in color and she called her PCP who told her to continue to take the antibiotics. She also bought some OTC cream, and an aloe vera plant which seems to be helping. She says that the dark skin has peeled off and the skin is pinkish and raw looking, which is a large area on her arm where every bump was. She said that the area is really really bad and is embarrassed to show her arm.
48 2021-06-01 breast pain Pt called call ceneter on 5/4/21. Noted no emergency s/sx. Pt stated she got 1st covid vaccine Pfize... Read more
Pt called call ceneter on 5/4/21. Noted no emergency s/sx. Pt stated she got 1st covid vaccine Pfizer 4/29/2021 at VSC and then pt got tiredness, arm pit soreness through chest soreness not chest pain, left breast soreness, muscle pain, headache, dizziness(pt denies emergency s/sx) from last Friday to today. Pt said all symptoms got better today. Pt took ibuprofen and hot tea for symptoms. Pt requests to make appt with MD d/t pt's health hx and appt scheduled for 5/5/21
48 2021-06-01 slurring Slur of words; tightness R jaw; ear pain; This is a spontaneous report from a contactable Nurse. A 4... Read more
Slur of words; tightness R jaw; ear pain; This is a spontaneous report from a contactable Nurse. A 48-Year-old Non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot number & expiry date not reported) dose 1 via unspecified route of administration on 12Feb2021 (at age of 48years) as 1st dose single for COVID-19 Immunization. Patient medical history and concomitant medications are not reported. Patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot number & expiry date not reported) dose 2 via unspecified route of administration on 03May2021 as 2nd dose single for Covid-19 immunization.Patient didnt receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was unknown On 12Feb2021, (On day of vaccination),Patient experienced Slur of words, tightness R jaw, Ear Pain. Patient received treatment for the adverse events by Depomedrol shot. Patient had to visit clinic for adverse events. The Clinical outcome of all events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of slurred speech,tightness of jaw muscles,ear pain cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
48 2021-06-01 pain in extremity This is a spontaneous report from a contactable consumer (patient). This is one of the 3 cases from ... Read more
This is a spontaneous report from a contactable consumer (patient). This is one of the 3 cases from same reporter. A 48-years-old female patient received second dose of bnt162b2 (COVID-19 mRNA VACCINE, Solution for injection, Lot /Batch Number: ER8736 and expiry date was not reported) via an unspecified route of administration in left deltoid at left upper shoulder on 17May2021 (at age 48-years-old) as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. No relevant family medical history was reported. No Prior Vaccinations within 4 weeks. No additional vaccine was administered on same date. Patient had previously received first dose of vaccine (LOT: ER8733; EXP: unknown) in left upper shoulder on 26Apr2021 and experienced fatigue. On 18May2021 (1 day after vaccination), patient was just tired (fatigue) and arm hurt really bad/ Her arm was really sore. She had gotten it in the left arm. She didn't throw up or anything. She was also dizzy and nauseous. Around lunch time, around noon, it really picked up and she got the chills for a short period of time, low grade fever and body aches. On an unknown date in May2021 (reported as the for the next day) She felt lousy. By around noon the next day she was back to normal. She worked half the day and ended up taking the rest of the day off and the next day off to recover. She wasn't scared or worried. No Treatment was received. Patient did not visit emergency room or physician office. Reporter seriousness for all events was unspecified. On an unspecified date in May2021, the patient resolved from the event "felt lousy". The outcome of other events was unknown. Additional information has been requested.
48 2021-06-02 bell's palsy bells palsy within 72 hrs on same side as injection; This is a spontaneous report from a contactable... Read more
bells palsy within 72 hrs on same side as injection; This is a spontaneous report from a contactable consumer reporting for self. This 48-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in left arm on 07May2021 02:00 PM (Lot Number: EW0168) at single dose for COVID-19 immunization. The patient is not pregnant. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included OTC cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE). The patient had allergy to famotidine (PEPCID). The patient previously received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in left arm on 16Apr2021 01:15 PM (Lot Number: ER8731) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced bells palsy within 72 hours on same side as injection. The event start date was reported as 09May2021. The event resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The patient was tested nasal swab (Abbott Binax) on 17May2021 with negative result. The patient received prednisone and valacyclovir as treatment. The outcome of event was recovering.
48 2021-06-02 muscle spasms severe cramping, the next day-fever, the following day-rash, vomiting & diarrhea, fatigue, vaginal b... Read more
severe cramping, the next day-fever, the following day-rash, vomiting & diarrhea, fatigue, vaginal bleeding, chest pain.
48 2021-06-02 muscle twitching Sporadic, lower left side uncontrollable facial twitching for approximately 12 hours
48 2021-06-02 pain in extremity After the second dose Felt run down the next day. Arm soreness lasted a couple of days. The one t... Read more
After the second dose Felt run down the next day. Arm soreness lasted a couple of days. The one that?s worrisome is the swelling at the injection site. That one is still present. It?s very noticeable when I raise my arm above shoulder height. It?s been two weeks. I hope it?s not permanent.
48 2021-06-02 restless legs syndrome, involuntary muscle movements The day of the vaccine I had the return of the dry cough, which I previously with COVID-19. I also... Read more
The day of the vaccine I had the return of the dry cough, which I previously with COVID-19. I also had mild chest pains. I had fatigue and felt sleepy. Within the first 24 hours of the vaccine, I had burning in the eyes. Within the next week I had more fatigue and sleepiness. Within a few weeks I had a more intermediate cough. The cough was not every day but every few days. About a month after the vaccine, I have had a cough every day. The worsening of other conditions, in late February into March, I had worsening of restless legs. I also had increased of my asthma symptoms which I had to increase my medication for the asthma. I had chest tightness until April 10th. On April 29th, I had increased fatigue and montenect jerk of my arm and legs. After a week or so of those symptoms, I saw my Rheumatologist she put me on a steroid of 6 days. The abnormal fatigues and fatigue improved after I started the steroid. I still have a little fatigue and intermediate dry cough. Also, with had a symptom of monocular diplopia, the doctor I saw thinks that was to the increased dry eye symptom. I think the symptoms have increase my autoimmune system to flare up. I still have to use the inhaler also more than I use too.
48 2021-06-02 tension headache, migraine fatigue, slept for five days; fatigue, slept for five days; severe headaches (tension and migraines)... Read more
fatigue, slept for five days; fatigue, slept for five days; severe headaches (tension and migraines) that don't go away; severe headaches (tension and migraines) that don't go away; neck and left shoulder pain; neck and left shoulder pain; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route of administration in right arm on 17Feb2021 at 05:00 PM as unknown, single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included migraines, depression from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX 20 mg); linaclotide (LINZESS 290 mg); buspirone (BUSPIRONE 30 mg) for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 18Feb2021 at 09:00 AM, patient experienced fatigue, slept for five days, severe headaches (tension and migraines) that don't go away, neck and left shoulder pain, had to go to emergency room twice for headaches, prescription medication for migraine doesn't work. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken with IV tramadol, Compazine, Benadryl. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-06-03 migraine 6 day migraine, daily headaches ever since.
48 2021-06-03 pain in extremity, tenderness Pain in arm and armpit; Pain in arm and armpit; Sore neck and jaw; Sore neck and jaw; Tongue very se... Read more
Pain in arm and armpit; Pain in arm and armpit; Sore neck and jaw; Sore neck and jaw; Tongue very sensitive and still sensitive; Now I have a knot in my armpit that is very tender; Now I have a knot in my armpit that is very tender; Headache; tired; irritable; My back hurt for days; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 18Feb2021 at 16:30 (at an age of 48-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. She had known allergies and had other medical history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in arm right on 28Jan2021 at 16:15 as 1st dose, single dose for COVID-19 immunisation. She did not take other vaccine in four weeks. She had taken other medications in two weeks. Patient not had COVID prior vaccination and not had COVID tested post vaccination. On 18Feb2021 at 18:00, the patient experienced pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days. The patient did not receive any treatment for the events. The clinical outcome of the pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days were resolving. No follow-up attempts are possible. No further information is expected.
48 2021-06-03 tingling Client, a 27yo female,who reported that following her first dose Pfizer COVID vaccine (LOT EW0182, E... Read more
Client, a 27yo female,who reported that following her first dose Pfizer COVID vaccine (LOT EW0182, Expiration 08/31/2021) received 05/06/2021 she felt her tongue swelling, her face tingling and a headache in her left temporal area. Client denied any other symptoms such as nausea, chest pain or shortness of breath. She stated the onset of symptoms was approximately 5 minutes post vaccine and lasted less than 20 minutes. She did not notify the EMTs at the time and did not notify her primary care provider because the symptoms resolved on their own. Client denied any other medical conditions or regular medication use. She stated positive for allergy to pollen and dust with a non-anaphylactic reaction, denied any other allergies to environment/medication/foods. Lead RN consulted with medical team.
48 2021-06-03 tingling PT INJECTED. PT FELT BETTER REPORTS FEELING LIGHTHEAD AND TINGLING TIGHNESS OF THE JAW. DENIES SOB D... Read more
PT INJECTED. PT FELT BETTER REPORTS FEELING LIGHTHEAD AND TINGLING TIGHNESS OF THE JAW. DENIES SOB DYSPNEA OR HIVES. PT HAS A HISTORY OF ASTHMA IN WICH SHE HAS A RESCUE INHALER FOR EMERGENCY. REPORTS THAT SHE HAS ONLY A PAIN @ THE INJECTION SITE WITH FIRST DOSE. PT INSTUCTED TO STA HYDRATED AND EAT AS PT DID NOT BEFORE GETHING INJECTED. PT FELT BETTER AFTER A FEW MIN. AS SYMPTOMS SUBSIDED. INSTRUCTED TO FINISH OBSERVATION TIME AND TO ALERT TEAM IF SYMPTOMS RETURN OR WORSEN
48 2021-06-04 pain in extremity Within a week after this she started her period. She states she just finished her period prior to th... Read more
Within a week after this she started her period. She states she just finished her period prior to this and is on birth control so her cycle is very regular; break through bleeding; Stiff neck; Pain in arm; Nausea; Neck pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0191and Expiry date: Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 25May2021 15:00 as 1st dose, single dose for covid-19 immunization. Relevant medical history was not included. The patient had no prior vaccinations within last 4 weeks. The patient experienced within a week after this she started her period. she states she just finished her period prior to this and is on birth control so her cycle is very regular on an unspecified date while break through bleeding experienced on 29May2021. Patient also experienced stiff neck, pain in arm, neck pain and nausea on 26May2021. The caller stated that patient had her first Pfizer Covid vaccine dose on 25May2021. Within a week after this she started her period. She states she just finished her period prior to this and was on birth control so her cycle was very regular. Within a few days of getting the shot, she has had some major breakthrough bleeding. She normally did not have that the only thing that changed in her life was that she got the COVID shot. She believes the breakthrough bleeding started Saturday night. It has gotten progressively worse. At first, it was just like a little bit of bleeding but, she full blown had her period. She didn't take her pills late or anything like that. She did not really know what she should do because this was really odd. she was still taking her birth control pills and takes vitamins. Caller mentions at first, she had the normal side effects like a stiff neck and pain in the arm. She also felt nauseas the next day. It was pretty normal stuff, then the breakthrough bleeding happened. The neck pain, pain in arm, and nausea started the next day after receiving the vaccine and lasted like 24 hours. Caller stated just out of curiosity, has anyone else had this issue. She was not asking for people personally if it is a side effect, but she believed everyone should be told about if this was one of the side effects. She wants to know if this had a side effect of the Covid vaccine. Therapeutic measures were taken as a result of events, patient took Advil. The outcome for event within a week after this she started her period. she states she just finished her period prior to this and is on birth control so her cycle is very regular and stiff neck was unknown, while the outcome for pain in arm, neck pain and nausea were recovered on 27May2021. The outcome for break through bleeding was not recovered.
48 2021-06-05 weakness On 4/18/21 at approximately 9:50am, client had just received her first dose of the Pizer vaccine (lo... Read more
On 4/18/21 at approximately 9:50am, client had just received her first dose of the Pizer vaccine (lot# EW0171 exp: 8/31/2021) at vaccination site. The client was sitting in the observation area after her vaccine when she started to feel very weak and lightheaded. EMT went over to assist when the client stated she was not feeling well and then promptly fainted. EMT called over to another nurse who helped bring the gravity chair over and assisted the client to lay down and started to take vital signs at 1000: blood pressure (BP) 108/62; heart rate (HR) 71, oxygen saturation (02) 99%. Client was alert and oriented to place, time, location, and person throughout her 30 mins. observation. The client very shortly after lying down stated that she was feeling better. The client's airway was patent. She did lose consciousness momentarily. The client did not fall or strike her head on the ground. The client then stated that she has routinely had similar experiences while receiving shots in the past that have led to her fainting as well. The client was monitored for 30 minutes after the initial syncope. EMT took the following vitals at 1005: BP 110/64, HR 72, 02 99%; 1010: BP 112/68; HR 70, 02 99%; 1015 BP 116/68, HR 72, 02 99%, 1020: BP 116/68, HR 74, 02 99%; 1025: BP 116/68, HR 70, 02 99%: 1030: BP 116/68, HR 72, 02 98%. The client?s vitals quickly returned to normal range for the client. After the 30 minutes of monitoring the client stated that she felt fine. The client had arrived with friends who were able to assist the client by driving her vehicle for her to go home. The client was instructed to seek medical assistance if any symptoms worsened throughout the day. The client left vaccination site around 1030 with a steady gait.
48 2021-06-05 flushing, tremor Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: D... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient was transported to Emergency Department, after 1 dose of epinephrine was given by EMT in store.
48 2021-06-06 migraine - Very severe migraine for five days. Vomitting for multiple days with migraine. - Very lethargic. ... Read more
- Very severe migraine for five days. Vomitting for multiple days with migraine. - Very lethargic. - Blood pressure was extremely high / very abnormal. Had to go to ER due to BP being so high/dangerous levels. No high blood pressure history. Was put on blood pressure medication and still taking it. Blood pressure is getting closer to normal, several weeks later.
48 2021-06-06 pain in extremity I went to chemo therapy in 2018 for colon cancer after colon resection surgery. During chemo my firs... Read more
I went to chemo therapy in 2018 for colon cancer after colon resection surgery. During chemo my first port failed and caused a huge blood clot in my neck and left arm. I have had three other events in my life of having blood clots, I did not know getting the vaccine would make me so susceptible for more. I got a huge blood clot in my neck and another one in my left arm after receiving the vaccination, my left arm swelled up huge at the elbow, with pain. Blood clots are not always painful for me, depends on where it?s at. I also have swollen lymph nodes in my armpits from the vaccine, confirmed by my oncologist. I went to the ER for the blood clots and again returned two days later to make sure I did not have PE, however the nodules in my lungs had enlarged and my lymph nodes are swollen. This is well after two weeks after I got the second dose of the vaccine, however, the blood clots take time to get as big as they are, so this probably started after the first injection, perhaps just got worse after the second one. I am now stuck on blood thinners forever because of this vaccine, I will not be getting any more of these shots.
48 2021-06-06 pain in extremity Bladder pain went to er(meds given) Superficial blood clot on right thigh(meds given) Calf pain righ... Read more
Bladder pain went to er(meds given) Superficial blood clot on right thigh(meds given) Calf pain right leg ***Er with bilateral pulmonary embolism ( hospital 3 nights) ***Dvt right leg(on warfarin)
48 2021-06-07 facial paralysis right sided facial droop; blurred vision; head pressure; This is a spontaneous report from a contact... Read more
right sided facial droop; blurred vision; head pressure; This is a spontaneous report from a contactable healthcare professional. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the left arm on 21May2021 14:45 (02:45 PM) (Batch/Lot Number: EW0171) (at age of 48-years-old) as 1st dose, single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as "Other". The patient's medical history included COVID-19 from an unknown date and unknown if ongoing. The patient was diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. The patient did not have any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. On 21May2021 14:45 (02:45 PM), the patient experienced right sided facial droop, blurred vision, and head pressure. It was unknown if the patient has been tested for COVID-19 prior to vaccination. Therapeutic measures were taken as a result of the events which included vitals (as reported). The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event right sided facial paralysis, blurred vision, and head discomfort cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
48 2021-06-07 hot flush, migraine, facial paralysis Severe fatigue re-activation of chronic Lyme symptoms debilitating severe fatigue and exhaustion HOT... Read more
Severe fatigue re-activation of chronic Lyme symptoms debilitating severe fatigue and exhaustion HOT FLASHES Sore throat Migraines Facial paralysis
48 2021-06-07 tremor loss of vision; very hard, large lump has surfaced in her left breast/originates from the lymph node... Read more
loss of vision; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; very hard, large lump has surfaced in her left breast/originates from the lymph node in her arm pit and runs to her nipple/Hard lump surfaced on lymph node at base of skull; 103 fever; constant shaking; uncontrollable vomiting; dry heaving; headaches; extreme aching in back and chest; extreme aching in back and chest; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration into left arm on 17May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included allergy to bees (known allergies: Bees). The patient's concomitant medications were none (no other medications the patient received within 2 weeks of vaccination), the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient previously received first dose of BNT162B2 for COVID-19 Immunization. The patient experienced very hard, large lump has surfaced in her left breast, It is shaped like a straw, over two inches long. it originates from the lymph node in her arm pit and runs to her nipple, Hard lump surfaced on lymph node at base of skull. During 72 hours following second shot: 103 fever, constant shaking, loss of vision, uncontrollable vomiting, dry heaving, headaches, extreme aching in back and chest, all on 18May2021 08:00. the adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures in May2021: blood test, mammogram, sonogram test with unknown results. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has not tested for COVID-19. treatment received for the events included Bloodwork, sonogram and mammogram. Outcome of the events was not recovered. It was reported as non-Seriousness. Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect were all no. Information on the lot/batch number has been requested.
48 2021-06-08 bell's palsy, facial paralysis, involuntary muscle movements Bell's palsy; The left side of her face was completely paralyzed; It started with her left eye, she ... Read more
Bell's palsy; The left side of her face was completely paralyzed; It started with her left eye, she stopped blinking, but she did not know it. She just felt like something was in her eye; She then realized her mouth was crooked. She could not move the left side of her mouth, she could not move the entire left side of mouth at all; She just felt like something was in her eye; This is a spontaneous report from a contactable consumer (patient). The 48-years-old female patient received bnt162b2, dose 2 via an unspecified route of administration on 20Mar2021 10:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization at the age of 48 years old. Medical history included Nebulizer and rescue inhaler for asthma for sudden symptom. This report was not related to a study or programme. No additional Vaccines Administered on Same Date of the Pfizer. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations was None. Family Medical History Relevant to AE was None. The concomitant drug was Nebulizer and rescue inhaler for asthma for sudden symptom. The patient previously received bnt162b2, dose 1 via an unspecified route of administration in Left arm on 27Feb2021 10:15 (Lot Number / Expiry Date: EN6202) as SINGLE DOSE for covid-19 immunization at the age of 48 years old. The patient experienced bell's palsy, the left side of her face was completely paralyzed, it started with her left eye, she stopped blinking, but she did not know it. she just felt like something was in her eye, she then realized her mouth was crooked. she could not move the left side of her mouth, she could not move the entire left side of mouth at all, she just felt like something was in her eye, all on 08May2021. Reported as: She was calling to report that she got Bell's Palsy from the vaccine. The adverse event started 08May2021, but she could not be seen by her doctor until Monday 10May2021. That is when she was officially diagnosed with Bell's Palsy. The event started slowly on 08May2021. The left side of her face was completely paralyzed. It started with her left eye, she stopped blinking, but she did not know it. She just felt like something was in her eye . It took her a while to realize it. She then realized her mouth was crooked. She could not move the left side of her mouth. She didn't realize the full effect until sometime between 4:00-5:00 , but it had initially already started early in the day, but she was not thinking anything of it. By 4:00-5:00 she could not move the entire left side of mouth at all. Treatment incldued Five days of steroid medicine. She was checked for all the tic born illnesses and negative for those. She had a CAT scan to make sure nothing is odd in the brain. They asked if she had a virus or head cold, but she has not had as much as a sniffle in two years. They checked everything and ruled everything else out and determined the vaccine caused. The AE(s) require a visit to Emergency Room and Physician Office: At first she thought she was having a stroke. She went to the ER first, but was in the waiting room for a three hours. The more she sat there she was reading up on the side effects. She saw details about Bell's Palsy and determined it was Bell's Palsy and not a stroke. Therefore, she left the waiting room and went to the doctor on Monday. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
48 2021-06-08 hot flush Heart rate was 145/ tachycardia; chest tightness/pain; chest tightness/pain; dizziness; hot flushes;... Read more
Heart rate was 145/ tachycardia; chest tightness/pain; chest tightness/pain; dizziness; hot flushes; itchiness on throat and tightness; BP 147/90; itchiness on throat and tightness; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 14May2021 08:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included PVC < 1 %. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included ascorbic acid; vitamin b complex (VITAMIN B); curcuma longa root (TURMERIC CURCUMIN) and Multivitamins. The patient previously took ibuprofen and experienced drug allergy (known allergies: Ibuprofen). The patient experienced heart rate was 145/ tachycardia, chest tightness/pain, dizziness, hot flushes, itchiness on throat and tightness, bp 147/90 on 14May2021 08:45. Reported as: approximately 5 -10 minutes after being vaccinated, I had sudden chest tightness/pain followed by tachycardia, dizziness and hot flushes, with itchiness on throat and tightness. Heart rate was 145 with BP 147/90. The adverse event result in Emergency room/department or urgent care. The patient received hydration with 0.9 NaCl to lower heart rate. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in May2021. Information about lot/batch number has been requested.; Sender's Comments: Based on data given, the event tachycardia is assessed as possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
48 2021-06-08 pain in extremity The same day around 4:00 pm extremely tired didn't do anything for the same day diarrhea. For the fi... Read more
The same day around 4:00 pm extremely tired didn't do anything for the same day diarrhea. For the first day i felt i was drunk. It went away after a day. Swore on the arm. Menopaused after the first shot.
48 2021-06-08 tremor, speech disorder Almost immediately following patient's second Covid vaccine, she felt dizzy and started sweating. A ... Read more
Almost immediately following patient's second Covid vaccine, she felt dizzy and started sweating. A few minutes later, she started shaking/trembling. Her blood pressure was a 185/128 and pulse was 109. Patient sat for about 20 minutes and drank a couple ounces of orange juice. She then developed some mild confusion and difficulty with speech. Her blood pressure at this time was 196/135 and pulse 107. A ambulance was contacted at that time. EMT assessed the patient and recommended triage to the hospital, which the patient refused.
48 2021-06-09 weakness "1/12 Vaccinated at 6pm. *pm chills and mild rigors started. 1/13/21 Woke up with difficulty walking... Read more
"1/12 Vaccinated at 6pm. *pm chills and mild rigors started. 1/13/21 Woke up with difficulty walking due to severe joint pain. Legs weak. By 3pm I was in bed for 16 hours with fever of 101-103. Uncontrolled rigors for 3 hours, headache, severe joint pain, dizziness and weakness. Took Tylenol every 8 hours and Motrin every 8 hours." Day of report "symptoms are subsiding but joint pain, weakness in legs, and low grade fever continue."
48 2021-06-09 weakness Body aches, weakness, headache, injection site pain.
48 2021-06-09 pain in extremity Severe back pain; joint pain; Unable to walk without pain; Arm pain; This is a spontaneous report fr... Read more
Severe back pain; joint pain; Unable to walk without pain; Arm pain; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6199 and Expiration date: unknown), dose 1 via an unknown route of administration, in left arm on 07Mar2021 15:15 as single dose for covid-19 immunisation (age at vaccination was 48 years). Medical history included kidney stones. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]). Patient has not received other vaccine in four weeks. Patient has no known allergies. Patient has not tested positive for covid prior and post vaccination. On 08Mar2021 at 12:00 AM, the patient experienced severe back pain and joint pain. She was unable to walk without pain 1-3 days after injection. The arm pain went away 2 days after injection. Outcome of events back pain, arthralgia, gait inability was recovering. Patient recovered from pain in extremity on 09Mar2021. No follow-up attempts are possible. No further information is expected.
48 2021-06-10 pain in extremity, weakness I had the pain under the bottom of my left foot like fire that would not go out, that pain was so un... Read more
I had the pain under the bottom of my left foot like fire that would not go out, that pain was so unbearable; I could not walk, the bottom of foot was swollen; I could not walk, the bottom of foot was swollen; Weakness; My mind went blank I couldn't remember something I do all the time I just went blank; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration in deltoid right on 24May202 (Batch/Lot Number: EW0187; Expiration Date: unknown) (at the age of 48-year-old) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date in the year 2020 to an unknown date in the year 2020. The patient's concomitant medications were not reported. The patient reported that she got the vaccine on the 24May2021 (Monday), by the 24May2021 (Monday night) "i had the pain under the bottom of my left foot like fire that would not go out, that pain was so unbearable" and that was the very same pain she had when she got the COVID the last year (2020), she had to be on round the clock medicine she could not walk, the bottom of foot was swollen just like she had the COVID last year, and there was a weakness. When I called to the doctor, the pain she was in, the doctor wanted her to go to the emergency room but she could not go to the emergency room it was so bad. When there was the weakness, she was so weak she just felt better this past Sunday (30May2021), that's how many stage it took me to come back to herself. The patient reported when the very day she got the vaccine she was at work and my mind went blank I couldn't remember something I do all the time I just went blank" and I could not remember. It was just that one shot to space the time and she was struggling couple of days after there was some struggle just remembering things all of that scary enough, but it was very concerning to the point where I could not want to take the second vaccine, that's how scary the whole experience for her. The outcome of the events was unknown. Was requested for additional information
48 2021-06-10 pain in extremity I felt very dry in my throat. I stay at the emergency room for a observation and received two Benadr... Read more
I felt very dry in my throat. I stay at the emergency room for a observation and received two Benadryl. I didn?t take Benadryl for my first shot. I saw a doctor the next day because it felt like I have sore throat. Currently I have pain in my right arm. It has been since April. I visited my doctor and have been told it is tendinitis. I saw Physical Therapist and now will see Orthopedic surgeon
48 2021-06-13 tremor, tingling, pain in extremity, muscle spasms, numbness I wake up almost every day now with tingling, numbness or pain in my hands. The right hand is worse ... Read more
I wake up almost every day now with tingling, numbness or pain in my hands. The right hand is worse than the left hand. Sometimes I am unable to open a basic water bottle as my grip strength is seriously compromised. The evening of the vaccine I went to bed early as I was super tired. I woke up in the morning and felt flu-ish which I knew could be expected. But my hands were cramped and it was hard to get them to open. For two days I couldn't type or hold a fork--I had to manipulate my hands with something other than my hands to stretch them out and get them to open and to stop shaking. It's been a bit over a month now and I'm still waking up with my hands sore, numb, asleep, cramped or a combination of all of these. There has not been one day that I haven't woken up like that. I have to type a lot for my work and it has compromised how much I can do at any one time. My hands need a lot of breaks. I am an avid knitter but I haven't been able to do that at all since my second vaccine shot on May 10th and I struggle to do other things that require grip and dexterity as well - like carrying a bag or using a hammer.
48 2021-06-13 tremor Seen at Medical Center HPI 48-year-old female had a Covid vaccine earlier today about 20 minutes aft... Read more
Seen at Medical Center HPI 48-year-old female had a Covid vaccine earlier today about 20 minutes afterwards developed dizziness lightheadedness and extreme fatigue. Went back to the clinic was given subcu epi and Benadryl. Patient feels a little bit better now but still feeling foggy and a little shaky. No rash no difficulty breathing or difficulty swallowing. Was fine prior to receiving the vaccine.
48 2021-06-14 hot flush Patient called to complain of an increased heart rate (180) BP of 142/100 hot flashes and headache f... Read more
Patient called to complain of an increased heart rate (180) BP of 142/100 hot flashes and headache for 4-5 days. She has gone to the ER for this. They gave her some things to try and will have a follow up tomorrow.
48 2021-06-15 feeling hot, pain in extremity, tingling Immediately after the shot (10:29 am) , the patient's arm developed a round, swollen area around the... Read more
Immediately after the shot (10:29 am) , the patient's arm developed a round, swollen area around the injection site that turned into a hard knot. Within 5 minutes, the patient described feeling hot, dizzy, experiencing an elevated heart rate, and her arm was hurting (10:34 am). Over the next 10-20 minutes her symptoms did not improve, but she began to feel light-headed and stated multiple times that she may pass out; She also described having a dry mouth and tingling sensations in her arm (10:45 am). We monitored blood pressure every 5 minutes, asked the patient to lay on the floor, and fanned her. She refused an ambulance initially, but did ask for one ~30 minutes after vaccine administration. Patient refused an epi-pen.
48 2021-06-16 weakness Dizziness; Weakness; Stiff neck; Nausea; Heart racing; Loss of appetite; feeling COVID-like symptoms... Read more
Dizziness; Weakness; Stiff neck; Nausea; Heart racing; Loss of appetite; feeling COVID-like symptoms; flu-like symptoms; achy; Diarrhea; Extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: ER8732; Expiration Date: Jul2021), via intramuscularly, administered in left arm on 30Mar2021 15:30 as single dose for covid-19 immunization. The patient medical history inclided allergic to all the cillins (As reported) and gluten. Concomitant medication was not reported. The patient did not receive any other vaccine in four weeks. She does not think so, the last vaccination, she remembers getting was when she was a child. On an unknown date, the patient calling regarding the COVID-19 vaccination. She was concerned because she had an immediate reaction after the shot, dizziness weakness stiff neck nausea heart racing all of that. Then she felt normal things afterwards like sore arm achy tired. that kind of stuff. Last week a week and half after the vaccination the patient started feeling COVID-like symptoms/ flu-like symptoms. She went on Friday and got COVID tested which she was negative. She slept for 19 hours in a 1.5 day period. She called to report these symptoms but also she read on the CDC site that if you had any reaction to the first shot you should not get the second shot. She was concerned on what to do because her second shot is scheduled for next Tuesday. The patient declined stating she has not gone to the doctor she only went to get COVID tested. She does not go to the doctor very often hardly ever. The patient clarified beginning on 06Apr2021 of last week she started having COVID-like symptoms/ flu-like symptoms. She clarifies these symptoms to be achy weak diarrhea extreme fatigue She did not leave the bed for a full day. She slept for 19 hours which is not like her at all. She had nausea. She did not eat she had loss of appetite. She did not have a fever though. She explains she has not recovered completely from these symptoms she was still tired and weak, but she was better now. She did warn them of her allergies prior to getting vaccinated and they had her sit there for 30 minutes after. The patient wants to find out if anybody else has had this type of reaction. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on unspecified date, it was Negative COVID-19 test. The outcome of the event was unknown. Communication: NDC Lot number and expiry date were not probed for her allergy to all the cillins as the caller did not provide a specific product name just a drug class. Communication: Provided report reference number. Referred caller back to her healthcare professional for any treatment recommendations or medical advice. For product specific questions about the COVID-19 vaccine caller was provided the number and hours of operation prior to attempted warm transfer. They was experiencing a high call volume at the time of the call. Caller was placed in the queue to hold for the next available agent. No follow-up attempts are needed. No further information is expected
48 2021-06-16 discomfort Right after the vaccination, within 10 minutes I started to feel pressure in my left arm down to my ... Read more
Right after the vaccination, within 10 minutes I started to feel pressure in my left arm down to my wrist. I also felt weakness in both legs. I went home and symptoms lingered and remained for over a week. Muscle weakness will come and go . I was driving in my car and I felt anxious and my chest very heavy and difficulty breathing. I stopped the car and was fortunate to be parked next to a fire department. They put me in an ambulance and checked my blood pressure which was high. They monitored me until my bp went down to the normal range and they allowed me to go home. For the next 6 days, I felt a constant pressure in my arm . I went to Urgent Care to seek care for the pressure on my arm. They did chest x ray and EKG- everything came back normal and to follow up with PCP. I have an appt to see my PCP. Currently I still have pressure/tension originating from left armpit to underneath arm all the way to wrist.
48 2021-06-16 feeling hot, numbness after 4 weeks still have lump on neck; next morning swelling and redness was in neck.; next morning ... Read more
after 4 weeks still have lump on neck; next morning swelling and redness was in neck.; next morning swelling and redness was in neck.; after 6 hours- left side of face was hot, swelled and numb feeling.; after 6 hours- left side of face was hot, swelled and numb feeling.; after 6 hours- left side of face was hot, swelled and numb feeling.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 29Apr2021 10:00 (Batch/Lot Number: EW0172) as single dose for COVID-19 immunisation. Patient age at vaccination was 48 years old. The patient medical history was not reported. Patient was not pregnant. Concomitant medications included other medications within 2 weeks of vaccination. The patient previously took fluconazole (DIFLUCAN) and experienced allergy. Historical vaccine included 1st dose of BNT162B2 (lot number=ER8733) on 01Apr2021 in left arm for COVID-19 immunization at age of 48 years old. After 6 hours (29Apr2021 16:00)- left side of face was hot, swelled and numb feeling. Next morning (30Apr2021), swelling and redness was in neck. After 4 weeks, patient still had lump on neck. The events resulted in emergency room visit. Patient received treatment for the events included diphenhydramine hydrochloride (BENADRYL) and steroids. The events were not resolved at the time of reporting.
48 2021-06-16 grand mal seizure Grand mal seizure
48 2021-06-16 numbness, pain in extremity she felt like she had been hit by a truck, she felt horrible; fever; chills; her hands have been puf... Read more
she felt like she had been hit by a truck, she felt horrible; fever; chills; her hands have been puffy and painful; her hands have been puffy and painful; This event started with her knuckles and then about a week ago went up to her wrist. Her hands still hurt but now it has spread up to forearms.; she can barley separate them, her fingers; hands are kind of numb but are also very painful; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 48-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/lot number and expiry date: not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 23May2021 13:15 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number and expiry date: not reported) via an unspecified route of administration, administered in Arm Left, three weeks before the second dose at 12:45pm as single dose for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as no. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as no. Prior Vaccinations (within 4 weeks) was reported as no. Family Medical History Relevant to AE was reported as no. Adverse events following prior vaccinations reported as no. Concomitant medications included escitalopram oxalate (LEXAPRO) 20mg once a day, taken for depression from Apr2020 to an unspecified stop date; lamotrigine (LAMOTRIGINE) 200 mg once a day , taken as a mood stabilizer from Apr2020 to an unspecified stop date. On an unspecified date in May2021, the patient felt like she had been hit by a truck, she felt horrible, experienced fever, chills, hands puffy and painful, hands numb but also very painful and can barely separate her fingers. The course of the events according to the reporter was ‘After the second vaccine, on the second day, she felt like she had been hit by a truck, she felt horrible. It is reported she had fever and chills and her hand and feet hurting so bad. For 2-3 weeks her hands have been puffy and painful. Little by little the symptoms went away except for her hands, the puffiness and pain is still on going. This event started with her knuckles and then about a week ago went up to her wrist. Her hands still hurt but now it has spread up to forearms. When she gets up in the morning her hands are so puffy and painful. She is taking Tylenol, Motrin, Ibuprofen. The caller also mentions she has been taking Neurontin which helps a little bit. She feels like someone is stabbing her in the hand and palm and finger and in the morning she can barely separate them, her fingers. The caller says her hands are kind of numb but are also very painful. The caller confirms at this point all the events have resolved, they lasted about 5-6 days after starting except the issues with her hands.' The outcome of the event ‘felt like she had been hit by a truck, she felt horrible', fever, chills was reported as recovered. The outcome of the events hands puffy and painful, hands numb but also very painful and can barely separate her fingers was reported as not recovered. Relevant tests reported as no. The events did not result in visit to emergency room or physician office. Therapeutic measures were taken as a result of events. Information about batch/Lot number has been requested.
48 2021-06-16 pain in extremity Ache; Unable to hold her phone; Puffiness on her hands including her knuckle, wrist, palm and to her... Read more
Ache; Unable to hold her phone; Puffiness on her hands including her knuckle, wrist, palm and to her forearm; Fever; Nausea; Joint pain (Relative to knuckle); Pain in her hands and feet; Puffiness and pain in her feet; This a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on 23May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. On an unknown date, the patient experienced fever, nausea, and ache. However, the worst part that the patient reported and was seeking recommendation on about the pain in her hands and feet. The patient experienced puffiness and pain in her feet went away after a week, however the pain and puffiness on her hands including her knuckle, wrist, palm and to her forearm was intolerable to the point that she was unable to hold her phone. The patient took Tylenol and other pain medications but seem not to work. There were also reports of joint pain (relative to knuckle) and injection pain but not in particular on the hand area specific to the locations she reported but having no information. The outcome of the events ache, unable to hold her phone, puffiness on her hands including her knuckle, wrist, palm and to her forearm, fever, nausea and joint pain (relative to knuckle) was unknown and recovered/resolved from puffiness and pain in her feet, pain in her hands and feet on an unknown date. Information on the lot/batch number has been requested.
48 2021-06-17 flushing, feeling hot, throat numbness Note from NP at clinic 6/11/21: "She (pt.) received the shot and about 5 minutes later started to fe... Read more
Note from NP at clinic 6/11/21: "She (pt.) received the shot and about 5 minutes later started to feel flushed, tachycardic, and said her throat felt "numb." She was laid down on a cot, her vitals were taken (BP 148/90 and pulse 112 apical), she was given 25mg of liquid Benadryl and symptoms resolved after about an hour. She was given instructions to contact her PCP Dr. after leaving the clinic and should symptoms return to go to the ER for further evaluation." Follow-up note from Health Department Medical Director 6/14/21: "She (pt.) told me that within 5 minutes of having the Pfizer she developed numbness of her lips and tongue and a sensation of throat numbness. She was evaluated and her BP was high and she was tachycardic and she was told to lay down. She felt some trouble breathing more with laying down and she had some nausea in addition to some itchiness of her face and neck. She was given Benadryl. She also remembers having almost an instant headache and hot feeling with her symptoms. Once the Benadryl started to take effect, she felt her breathing and tingling and itchiness was better. She did go to see her primary care that same day and her symptoms did return. She was given steroids orally and told to take Benadryl every 4 hours. She noticed that her symptoms of throat tingling and lip tingling and face and neck itchiness and splotchiness would return when she was due for Benadryl. The last time she noticed this was Saturday morning. She is still taking Benadryl every 4 hours and is no longer having any symptoms as of today."
48 2021-06-18 feeling hot, pain in extremity Dizzy; Veritgo; Warmth; Tingly tongue; Very sore arm; This is a spontaneous report received from a c... Read more
Dizzy; Veritgo; Warmth; Tingly tongue; Very sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6203) via an unspecified route of administration in the right arm on 17Mar2021 at 10:30 hours (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included IBD (Inflammatory bowel disease). The patient was known allergic to penicillin.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included multi vitamins (MANUFACTURER UNKNOWN), Vitamin C (MANUFACTURER UNKNOWN), juleber (MANUFACTURER UNKNOWN), immodium (MANUFACTURER UNKNOWN), tyle (MANUFACTURER UNKNOWN) within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, the patient experienced warmth at 05:30 hours, then tingling tongue and very sore arm. Next morning at 05:30 hours,the patient felt dizzy and vertigo. The patient did not receive any treatment for the adverse events. The clinical outcome of the events warmth, tingling tongue, very sore arm dizzy and vertigo was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
48 2021-06-18 hot flush Since getting my first shot on April 9, I have been having hot flashes, mostly and night; have not m... Read more
Since getting my first shot on April 9, I have been having hot flashes, mostly and night; have not menstruated at all; This is a spontaneous report from a non contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) at the age of 48-year-old as single dose for covid-19 immunisation. The patient was not pregnant. Medical history included ongoing pre-menopausal. The patient had no known allergies. Other medical history reported as none. Concomitant medication included mometasone furoate (NASONEX); fexofenadine hydrochloride (ALLEGRA); both taken for an unspecified indication, start and stop date were not reported. Since getting her first shot on 09Apr2021, the patient had been having hot flashes, mostly and night, and had not menstruated at all. Although she was pre-menopausal, she did not have these issues before being vaccinated. Adverse events start date was Apr2021. No treatment received for the events. The outcome of the events was not recovered. Events reported as non-serious. The patient had no Covid prior vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 30Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-06-18 muscle spasms Bad spasms in back and right side. Muscles contracted so much I popped my right patella and displace... Read more
Bad spasms in back and right side. Muscles contracted so much I popped my right patella and displaced my tibia and fibula. Could not walk for 4 days. Still in tons of pain and walk with limp. Can barely walk stairs.
48 2021-06-18 pain in extremity Swollen left underarm glands; Pain down the upper arm; Fever; Chills; Dizziness; Nausea; Vaccine adm... Read more
Swollen left underarm glands; Pain down the upper arm; Fever; Chills; Dizziness; Nausea; Vaccine administered in left leg; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN0207) via an unspecified route of administration in left leg (characterised as vaccine administered at inappropriate site) on 16Mar2021, at 14:00 hours, (at the age of 48-year-old) as a single dose, for COVID-19 immunisation. Medical history included high blood pressure. Prior to vaccination the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No medications were received within 2 weeks of vaccination. Since the vaccination patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 17Mar2021, the patient experienced swollen left underarm glands, pain down the upper arm, fever, chills, dizziness and nausea. The clinical outcome of the events swollen left underarm glands, pain down the upper arm, fever, chills, dizziness and nausea was not recovered at the time of this report. While it was unknown for vaccine administered at inappropriate site. No follow-up attempts are needed. No further information is expected.
48 2021-06-18 pain in extremity itchy throat and puffy itchy eyes a couple of hours later, Benadryl used, then EpiPen later as itch... Read more
itchy throat and puffy itchy eyes a couple of hours later, Benadryl used, then EpiPen later as itching got worse and lip-tingling got started, pounding headache, bruised and very sore arm: took Motrin
48 2021-06-19 pain in extremity It has been almost 5 months and my injection site On my right arm is absolutely excruciating pain al... Read more
It has been almost 5 months and my injection site On my right arm is absolutely excruciating pain all the time it is so much more worse at night my arm is completely sore in that spot it hurts and I?m not sure what the problem is. It is not getting any better it is actually getting worse. At the point where sometimes I want to cry I cannot raise my arm up in my arm is just all the time in pain.
48 2021-06-20 numbness Numbness of legs, unable to sleep, out of breath, feels as though she would pass out, dizzy and naus... Read more
Numbness of legs, unable to sleep, out of breath, feels as though she would pass out, dizzy and nauseau
48 2021-06-20 pain in extremity On Thursday, June 17th, I had a very difficult time remembering the day of the week, and specific ta... Read more
On Thursday, June 17th, I had a very difficult time remembering the day of the week, and specific tasks that I was working on that I do daily on a regular basis. I also had to think additionally for the simple tasks that I perform at work, and noticed that I also had some recall issues with remembering server names and people's names. I couldn't keep my concentration on a single task. I am a multitasker by profession. Loosing my concentration ability, or my inability to focus on my assignments, cause stress-induced panic attacks throughout the day on June 17, and June 18th. On June 17th in the morning, I noticed that both of my leg muscles immediate behind my knees started to tense up as I stretched my legs, bent my legs to sitting position, and also when I walked the stretch in my calves was painful. Starting June 17th evening, I noticed that getting into bed and out of bed resulted in the stretching in both of my legs starting to prevent me from being able to move freely as I did before June 16th at 12:45pm. Since June 17th both of my arms when stretched wide are feeling the same tension pain as my leg muscles. The arms are also tender to touch in the front muscle areas (both arms, FYI), in the crevis, and in my lower arms when I ball my fists. I am using a topical pain relief ointment -- Pain-a-Trate -- daily on both arms and both legs in the adverse event sites three times a day. My last treatment was June 21st at 7am. Additionally, I have been monitoring my blood pressure and am noticing slightly lower numbers (on 6/19/2021, my AM reading was 131/85). I will continue to monitor my blood pressure daily and will report any increase or decrease to the VAERS. My anxiety is another event that started to surface on Saturday, June 19th along with the stiffness in my muscles in both legs (back of knee and calf areas) and both arms. This caused me to have some panic attacks and I informed my children of my symptoms in the event I died or had a stroke or heart attack from the COVID-19 vaccine dose 1 of Pfizer.
48 2021-06-21 cold sweat While in recovery about 13 mins pt complained of dizziness, headache became clammy, diaphoretic. no ... Read more
While in recovery about 13 mins pt complained of dizziness, headache became clammy, diaphoretic. no LOC, no SOB no nausea or vomitting. Rt arm vaccine site benign, no redness, no swelling. Applied ice pack to neck, gave water for hydration. pt stated only coffee in am little nourishment Elevated feet. VS taken 10:30 138/80, hr rate 81 reg strong. resps 16 reg non labored 97% O2 sat. Monitored for 30 min. Pt stated "I feel much better" Provided reassurance, encouraged hydration, arm movement, tylenol for aches if needed. Okd to exit after 30 min.
48 2021-06-21 night sweats Night seats ,Fatigue, shortness of breath.
48 2021-06-21 tingling As I was being monitored after receiving the vaccine, I began to feel lightheaded. The pharmacy tech... Read more
As I was being monitored after receiving the vaccine, I began to feel lightheaded. The pharmacy tech told me this was normal and it would subside in 24 hours, but it became more intense throughout the evening. I also experienced tingling in the legs and arms (mainly the legs) for about 4 weeks. In addition to the being lightheaded, I have been fatigued. Within the past month, I sometimes see yellow spots that come and go and have become extremely sensitive when I am in the sun and hot temperatures which intensifies the lightheadedness. Within the first two weeks of receiving the vaccine, I went to (urgent care), my primary care facility, and the emergency room. I went to a neurologist in early April and am currently still under his care.
48 2021-06-22 migraine Heart rate up and down, fatigue, deep breath pain in lung Blood pressure up and down. Migraines an... Read more
Heart rate up and down, fatigue, deep breath pain in lung Blood pressure up and down. Migraines and headaches Diarrhea and
48 2021-06-23 numbness, tingling, facial pain, facial paralysis Lip and tongue swelling and facial palsy on left side (started 45 minutes after injection). 5-day re... Read more
Lip and tongue swelling and facial palsy on left side (started 45 minutes after injection). 5-day regimen of Prednisone was prescribed on 4/21/21 Facial palsy continued for 6 weeks, sensation of tongue and lip swelling persists to today. In addition, intermittent sharp pain from left cheek to left ear. Numbness and tingling in extremities, which started within 15 minutes of injection, persist to today. Fatigue, which set in after initial 5-day regimen of Predisone, persists to today. A 30-day regimen of Prednisone was prescribed on 07/23/21.
48 2021-06-23 numbness, tingling Muscle aches and pain included tingling or numbness started June 1st 2021. A couple days later, I di... Read more
Muscle aches and pain included tingling or numbness started June 1st 2021. A couple days later, I did the CDC Checker. It stated I had the flu and to quarantine for 10days and take influenza vaccination. Pain started at 11 on 1 to 10 scale. Today, it?s at 1 on a scale of 1 to 10. Mostly pain, a lot of sweating, nausea, vomited 4 times and everything else is over. I did a TeleDoc visit, however, it was an LPN versus doctor. So I didn?t take her advice and go to hospital. When I could drive went to CVS drivethru minute clinic
48 2021-06-23 numbness NUMBNESS FROM BOTH ARMS SITE TO FINGERS. FATIGUE FOR 2 DAYS CHEST TIGHTNESS
48 2021-06-23 nerve pain Within hour of first injection, Myocarditis reaction, diarhea for days, EXTREME headaches and vagus ... Read more
Within hour of first injection, Myocarditis reaction, diarhea for days, EXTREME headaches and vagus nerve pain and feeling like I was having an allergic reaction that would not clear up. Still ongoing; brain fog, general malaise, chronic fatigue, vagus nerve issues, gut issues, still feel flu like and it has been months since i had both vaccine shots. I feel like I'm having an extreme auto immune inflammatory response that no one can help me with. Prior to this we could not pinpoint my exact auto immune disease (except lyme and co infections) but I had gotten it into a "remission like state." Prior to the vaccine I was symptom free. Everything has gotten worse again since the vaccine. Difficult to work, do daily functions etc. Also a large lymph node on back right of neck that has not bothered me since childhood was enlarged for weeks but that has gotten better.
48 2021-06-24 burning sensation My arm feels like it's on fire feels like an incision infected but worse on fire with 1st injection ... Read more
My arm feels like it's on fire feels like an incision infected but worse on fire with 1st injection put in left 2nd in right arm. Excessive pain then normal extremely then normal, horrible sore throat, fever this was with 2st injection im starting with 2nd already same. With 1st vaccine I was in bed 5 days. My memory since the 1st injection has been horrible I really have severe loss of memory. Nauseous. I know there is more since this is 1st full day of 2nd vaccine I will write down. I just feel like the flu but worse. I feel like I'm going to die it's horrible!!!!!!
48 2021-06-24 migraine Slight cough; Chills; body aches; fatigue; migraine; Sore throat; This is a spontaneous report from ... Read more
Slight cough; Chills; body aches; fatigue; migraine; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3247) via an unspecified route of administration in left arm on 01Feb2021 at 12:30 as 1st dose, single for COVID-19 immunization. Medical history included recurring sinusitis, recurring migraines, hypothyroid, anxiety. Patient had allergies with Codiene, Dillauded. Concomitant medications included thyroid (ARMOUR THYROID), guaifenesin, pseudoephedrine hydrochloride (MUCINEX D), levocetirizine dihydrochloride (XYZAL), ibuprofen, ergocalciferol (VIT D). Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not pregnant. On 06Feb2021 at 04:30 PM, patient experienced slight cough, chills, body aches, fatigue, migraine, sore throat. No treatment was received for the adverse events. Patient had not been tested covid post vaccination. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
48 2021-06-26 breast pain, pain in extremity After both vaccines I had the typical fatigue, headache and sore arm. But, I also experienced painf... Read more
After both vaccines I had the typical fatigue, headache and sore arm. But, I also experienced painful breasts and heart palpitations after both vaccines. I'm still experiencing heart inflammation, high blood pressure (which I didn't have previously) and it's past 2 weeks after my 2nd shot.
48 2021-06-26 muscle twitching, muscle spasms Event: heart rate spikes (up to 175 bpm) upon standing, extreme dizziness, chest pain, intense full-... Read more
Event: heart rate spikes (up to 175 bpm) upon standing, extreme dizziness, chest pain, intense full-body itching, vertigo, difficulty focusing eyes, extraordinary fatigue, muscle twitching / spasms, extreme cognitive issues, "flu-like" muscle and joint pain, fever and low-grade fever (99.5-102 degrees), swelling at injection site. Symptoms diminished after 12 weeks but remain. Developed an extensive rash under clothing after being outside for 5-10 minutes. Happened every time I went outside. This has not resolved.
48 2021-06-27 tingling tinglin to hands, wrist, some dizziness when she stands up. States she had a reaction to Pfizer vacc... Read more
tinglin to hands, wrist, some dizziness when she stands up. States she had a reaction to Pfizer vaccine 2 weeks ago, and was put on BB to slow her HR and BP.
48 2021-06-28 breast pain On day two after my shot the area where they gave me they shot was itching and had a red and hot ova... Read more
On day two after my shot the area where they gave me they shot was itching and had a red and hot oval spot around it. Through out the day it spread and I felt swollen down my arm and into my hand. I was also sore around my upper breast or armpit side. Today on day three it is still there and spreading around my arm. It is still itching and hot.
48 2021-06-28 numbness Right pinky went numb and is still experiencing numbness. Right arm numbness in hand and blockage fe... Read more
Right pinky went numb and is still experiencing numbness. Right arm numbness in hand and blockage feeling in upper arm close to bone.
48 2021-06-28 pain in extremity Sore arm and hand. started dwelling and hives appeared all over back of legs back face stomach botto... Read more
Sore arm and hand. started dwelling and hives appeared all over back of legs back face stomach bottom of feet. swelling was only on left side.
48 2021-06-29 flushing, numbness, tingling Raynaud's like symptoms; Numbness of finger tips; paleness of fingertips; flushing; tingling; This i... Read more
Raynaud's like symptoms; Numbness of finger tips; paleness of fingertips; flushing; tingling; This is a spontaneous report from a contactable nurse, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via intramuscular route in the left arm on 09Jan2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphocytic colitis. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EK5730) in the left arm on 19Dec2020 at 12:00 (at the age of 48-years-old) as a single dose for Covid-19 immunisation. Past drug history included allergic to TORADOL. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included PRISTIQ and budesonide (MANUFACTURER UNKNOWN) for unknown indications. On 01Feb2021, the patient experienced raynaud's like symptoms, numbness and paleness of fingertips, followed by flushing and tingling. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of the events raynaud's like symptoms, numbness and paleness of fingertips, followed by flushing and tingling was not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
48 2021-06-29 numbness, pain in extremity, discomfort, weakness Half an hour after the dose was administered, I began to feel numbness and pain in my arm, as the ho... Read more
Half an hour after the dose was administered, I began to feel numbness and pain in my arm, as the hours passed the pain intensified to the point of not being able to mobilize the arm in a normal way. body began to feel that it was very uncomfortable to fall asleep. At dawn I woke up with a lot of pain in the rib cage, however I went to work, being at my place of work I began to feel without strength to stand, with a lot of headache and chills. I left the workplace and came home to bed and from there, fever and general discomfort in my body. Until today I am still resting, it should be noted that today I have not had a fever, the pain in my arm is less but the pain in the body continues.
48 2021-06-29 pain in extremity Glands under arm sore and swollen days after vaccine; Glands under arm sore and swollen days after v... Read more
Glands under arm sore and swollen days after vaccine; Glands under arm sore and swollen days after vaccine; This is a spontaneous report from a contactable consumer or other non health care professional (patient) via Pfizer Sales Representative. A 48-year-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date (at the age of 48-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced glands under arm sore and swollen days after vaccine on an unspecified date. The outcome of all events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-06-29 pain in extremity I am having severe pain at times at the site of the injection and extending outward (block of pain i... Read more
I am having severe pain at times at the site of the injection and extending outward (block of pain in my top arm). I have to move my arm around in circles to try to bring relief to the pain & discomfort once it starts.
48 2021-06-29 pain in extremity pain under left arm; swelling the size of half a baseball in armpit; fatigue; headache; This is a sp... Read more
pain under left arm; swelling the size of half a baseball in armpit; fatigue; headache; This is a spontaneous report from a contactable other healthcare professional (patient) reporting herself. A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, Expiry date was not reported), dose 2 via an unspecified route of administration, administered in left arm on 02Feb2021 (at 48-years-old) as single dose for covid-19 immunisation at hospital. Medical history included low thyroid, spondyloarthritis and fibromyalgia. The patient has allergy to celexa and zithromycin. Concomitant medications included levothyroxine, cetirizine hydrochloride (ZYRTEK), medroxyprogesterone acetate (DEPO PROVERA), ibuprofen, ascorbic acid, colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMIN) and apple cider vinegar gummies.The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1, intramuscular, administered in left arm on 13Jan2021 at 16:00 (Batch/Lot Number: EK9231, Expiry date was not reported) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and since vaccination the patient has not been tested for covid-19. It was reported that, on 04Feb2021, at 04:00 AM the patient experienced pain under left arm with swelling the size of half a baseball in armpit, fatigue and headache. There was no treatment received for the reported events. The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.
48 2021-06-29 pain in extremity scratchy throat; blisters on the roof of mouth; sore arm; This is a spontaneous report received from... Read more
scratchy throat; blisters on the roof of mouth; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via an unspecified route of administration on 15Mar2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy, environmental allergy and exercise induced anaphylaxis. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 16:00, the patient experienced scratchy throat, not a big deal but also got blisters on the roof of the mouth, the kind of burn in the mouth from a hot beverage, and sore arm until day 3. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore throat, pain in arm and blisters was not recovered. No follow-up attempts are needed. No further information is expected.
48 2021-06-29 tingling This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6199), via an unspecified route of administration in the left arm on 18Mar2021 at 15:30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included thyroid issues. Concomitant medications were not reported. The patient was allergic to penicillin and sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 15:30, the patient experienced immediate tingling in arm, wrist and hand of left arm where vaccine was given. The jaw and neck pain was experienced on left side within 5 minutes of receiving vaccine. The pain continued in neck and moved to shoulder in evening. The lymph node on left side became swollen and painful. The red bumps on back of neck, back, shoulder area appeared by evening where vaccine was given. All the symptoms were on left side, which was the side vaccine was administered. On the second day, neck and shoulder pain persisted and bumps grew in size and quantity and continued to be painful. The lymph node continued to be swollen and sore to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events tingling, jaw pain, neck pain, shoulder pain, swollen lymph node, lymph node pain and red rash was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-06-30 feeling hot, tremor Pulse rate 150/min; I felt warm on my left arm and whole back; tremors; Blood pressure check 150/89;... Read more
Pulse rate 150/min; I felt warm on my left arm and whole back; tremors; Blood pressure check 150/89; This is a spontaneous report from a contactable Nurse (patient herself). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0217; Expiration date: unknown) an unspecified route of administration, administered in Arm Left on 15Jun2021 13:15 (Batch/Lot Number: EW0217) as single dose for COVID-19 immunization. Medical history included drug hypersensitivity. Concomitant medication included vitamin NOS (MULTIVITAMINS ) taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. It was reported that within 20 minutes after the vaccination on 15Jun2021 13:30 she felt warm on left arm and whole back, tremors. blood pressure checked and it was 150/89 and pulse rate 150/min. The adverse event resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events as patient received treatment with pepcid, cardiac monitoring and chest x-ray. The patient underwent lab tests and procedures which included blood pressure measurement: 150/89 on 15Jun2021, on Jun2021 cardiac monitoring, chest x-ray results not reported and heart rate: 150/min on 15Jun2021. The outcome of events was recovering. Further information has been requested.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the event "tachycardia" and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
48 2021-06-30 pain in extremity I was having chills and coughing and a headache and my left arm was sore.
48 2021-06-30 pain in extremity My biggest complaint is that I am now 66 days out from the first shot and no period. I did get sick... Read more
My biggest complaint is that I am now 66 days out from the first shot and no period. I did get sick from both the first and second shot (sore arm, fevers, fatigue, unable to function - especially on the second shot). But I should have had a period between the 1st and the 2nd - and there was nothing. I finally had some spotting last week. But still literally nothing. This is really frustrating and frankly scary.
48 2021-06-30 tingling Fever; Chills; Feels extremely tired; Feels very sleepy; When doing her daily activities she feels d... Read more
Fever; Chills; Feels extremely tired; Feels very sleepy; When doing her daily activities she feels dizzy; She felt like poison was going through her body; Feels like she has low blood pressure; Whenever she starts having activity in her body she feels tingling on her hands, face, and nose; View starts to get cloudy; felt agitated; heartbeat was really fast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 11Jun2021 (Lot Number: EW0217) at the age of 48-year-old as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, was diagnosed a few years ago, like four or five years ago, she normally takes her medication whether she does or does not have high blood pressure that way she keeps it under control. Family medical history was none. Concomitant medication(s) included amlodipine taken for high blood pressure from an unspecified start date and ongoing; metoprolol taken for high blood pressure from an unspecified start date and ongoing. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in Left Arm on 21May2021 (Lot Number: EW0186) at the age of 48-year-old for covid-19 immunisation. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The next day of Pfizer COVID-19 vaccine, on 12Jun2021, patient had a fever, chills, and was really tired and really sleepy. The patient stated that she felt like poison was going through her body, and today she was still waking up and feeling dizzy. The patient stated that she felt like her body has little ants inside of it and it felt like she had low blood pressure. The caller stated that she went to work and her heartbeat was really fast, so she had to go home because she felt like she was going to faint. She said that when doing her daily activities she feels dizzy. The patient asked if this was normal and how long these will last. The patient stated that in the first three days it felt like tiny like bugs were inside of her but that went away. After that, she continued to feel extremely tired and whenever she started having activity in her body she felt tingling in her hands, face, and nose, like tingling all inside her. The patient stated that when she returned to work her body continued to be in movement and her view started to get cloudy and she felt like she was going to pass out and felt her heart beating very hard. The patient stated that she felt like her heart was going out of her body and this happened when she has activity she started feeling dizzy. She said that she was having tingling and it felt like her heart was going to jump out of her body and she also felt very tired, very sleepy and that did not go away. The patient stated that her vaccine was on 11Jun2021 and on that night she started having symptoms. On 12Jun2021, she could not get up and on 13Jun2021 she returned to work and she was feeling like she reported earlier so she had to leave work. The patient stated that she felt agitated when she started doing things and whenever she started an activity she felt like that. The patient stated that she suffered from high blood pressure so she takes amlodipine and metoprolol for high blood pressure. She stated that she took her blood pressure two days ago and it was normal. Patient went and took her blood pressure right now and it was 123/82, which she states was normal. Patient took the test once and tested Covid-19 negative, that was before the first dose. The patient stated that because she was protected from the first dose she did not take another test before the second one because it was just 15 days later. The patient asked will her symptoms go away eventually or does she have to go to the doctor so that they can help her with them. The patient stated that she took paracetamol for her symptoms. The events did not result in Emergency Room or Physician Office. Outcome of the events felt extremely tired, very sleepy, heartbeat was really fast and tingling were not recovered, while unknown for the other events.
48 2021-07-01 feeling hot, feeling cold Her body produces mucous/blowing her nose; She had a horrible cough she couldn't get out; her blood ... Read more
Her body produces mucous/blowing her nose; She had a horrible cough she couldn't get out; her blood clot was already high; lose her voice; She had chills; rattle in her chest; She was cold ,and it was hot (88 degrees); She was sweating, and was warm all over her body.; She was sweating, and was warm all over her body.; Her throat seemed sore after.; She had dry cough. It felt dry; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0183, NDC number and Expiry date: Unknown), via an unspecified route of administration, administered in left arm on 01Jun2021 (at the age of 48-years-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing high WBC/white blood cell count increased and anaemic. Patient was overweight. Patient said that before the shot, she as been exposed to COVID-19 and never caught the virus. She has taken a COVID-19 test and it was negative two days ago and does not have COVID. Concomitant medication(s) included fenofibrate taken for blood cholesterol, colecalciferol (VITAMIN D 2000), iron, losartan and hydrochlorothiazide taken for blood pressure, from an unspecified start date and ongoing. It was reported that, two days after getting vaccinated, the patient got sick, and she feels like she has pneumonia. She was overweight. On an unspecified date in Jun2021, her body produces mucous/blowing her nose, and she had chills on 03Jun2021. Patient said that it all started a little after the shot. She felt like she had sand in her throat and she woke up feeling bad. She had a horrible cough on an unspecified date she could not get out. She still has a rattling in her chest. She wants to know if it is possible for this to stay in her chest and form a blood clot. Patient said that after vaccination, she had her nephew graduation, and she screamed at it. Then her throat seemed sore after and she would lose her voice, but it would come back. Her throat started hurting. As the days went on, she felt like there was dust in her throat. She had dry cough and it felt dry. It was like more dust had collected in her throat. Patient felt real sick, but she never had a fever. She was cold and it was hot (88 degrees) in and was sweating and was warm all over her body. Patient has a higher than normal WBC/ and that was one of her main concerns about getting the vaccine. Since her blood clot was already high and she was scared it would put her WBC in maximum overdrive. There was no investigation assessment. The patient underwent lab tests and procedures which included coagulation test: high on unspecified date in 2021 her blood clot was already high, SARS-CoV-2 test: Negative on 30May2021 and white blood cell count: high on unspecified date in 2021 (high white blood cell count). Patient wanted to know if there is any chance of getting pneumonia with the vaccine for which patient received response as "a review of the Prescribing Information for Pfizer COVID-19 vaccine failed to find any information regarding pneumonia being an adverse event with the vaccine". Patient was wondering if Pfizer is getting reports of side effects being full on pneumonia like symptoms that last. Patient asked if there was any chance that of blood clots after vaccination, and would like to know if anemic people who had the vaccine had adverse events and if there had been reports of cytokine storm and received response which says, failed to find any information regarding cytokine storm being an adverse event with the vaccine and was asked patient to consult with her doctor or health care provider for further guidance. The outcome of the events rattle in her chest, her throat seemed sore after, she had dry cough and her blood clot was already high was not recovered, and the outcome of chills, she got sick, her body produces mucous/blowing her nose, she had a horrible cough she couldn't get out, she was cold, and it was hot (88 degrees), she was sweating, and was warm all over her body and lose her voice was unknown. Information on Lot/Batch number was available. Additional information has been requested.
48 2021-07-01 tingling, numbness I had a immediate pain, numbness and tingling on the left side of my body. My menstrual cycle came e... Read more
I had a immediate pain, numbness and tingling on the left side of my body. My menstrual cycle came earlier than normal and I also had a swollen ankle.
48 2021-07-01 tremor, muscle spasms The second she injected I could feel it in my tongue, I could smell it. Within minutes when I starte... Read more
The second she injected I could feel it in my tongue, I could smell it. Within minutes when I started feeling dizzy, heart palpitations, vertigo, tachycardia, muscle spasm, trimmers, headaches, brain fog, memory lost, fatigue, nausea, chest pains, trouble breathing with exertion. This is ongoing since 03/30/2021.
48 2021-07-01 unresponsive to stimuli 48 y/o female with pmh of HTN, HLD, DM2 and bipolar disorder, transferred to ICU from the psychiatri... Read more
48 y/o female with pmh of HTN, HLD, DM2 and bipolar disorder, transferred to ICU from the psychiatric until after cardiac arrest. The patient was originally admitted on 5/22 for evaluation of bizarre behavior. She was noted to have flight of ideas, emotional instability and multiple attempts to leave the room naked. She was admitted to the floor there with behavioral health consulted for evaluation. She was then transferred to another unit on 5/27/21 for additional management, with a plan for a 90 day inpatient hold. While in the unit she was managed with a medication regimen including Thorazine, Lithium and Abilify. Medicine was consulted for management of hypertension, and Ob-Gyn was following for abnormal vaginal bleeding with work-up unable to be completed due to her mental status. ECT treatments were also started this week on 6/23, with the patient receiving her second ECT treatment this afternoon. From review of the pre-procedure note, the planned induction was with etomidate, succinylcholine, glycopyrrolate, and Brevitol (methohexital, barbiturate class); the actual MAR is not up to date with her procedural medications at the time of admission. Post treatment, the patient was noted to be conversive and in her normal state of health. This evening, nursing staff heard a loud noise from the patient's room around 1630. Upon arrival, they found her down, unresponsive and without a pulse. An ACT was called and CPR was initiated for a duration of approximately 30 minutes. Reportedly the AED display showed asystole, followed by PEA. She received a reported five rounds of epinephrine, one dose of bicarbonate, and one dose of calcium during the event. The patient was intubated during the code with a large amount of gastric contents present, concerning for aspiration. A right ankle IO was placed due to significant difficulty securing access elsewhere. ROSC was obtained with a junctional rhythm, and the patient was transferred for further management. On arrival the patient is non-responsive without any sedation running. She became hypotensive by arrival to the ICU requiring norepinephrine. On later inspection of her IO, there was suspicion for infiltration of fluids and medications around her right ankle. She has had significant secretions into her ETT since transfer. HPI as noted above. ICU course notable for hypoxic respiratory failure with ARDS likely from lung injury from cardiac arrest. She subsequently developed shock and required vasopressors. Initially the patient was noted to have brainstem reflexes, however on 6/25 the patient had an exam change with no spontaneous breaths and pupils fixed and dilated. The initial head CT following arrest was performed which showed diffuse cerebral edema with effacement of the sulci and gray and white matter differentiation consistent with severe anoxic brain injury. There was diminished ventricular size with complete effacement of the fourth ventricle and tonsillar herniation from mass effect. Neurology was consulted. The patient remained on vasopressor and mechanical ventilator support. A NM scan was performed to evaluate cerebral blood flow showed absence of effective cerebral perfusion. Neurology performed an exam and the patient was pronounced deceased at 1802 on 6/27/21 a doctor. The family was informed of the results. After discussion with family, the patient was removed from mechanical ventilator support and vasoactive medications discontinued with the family at beside.
48 2021-07-02 discomfort Heaviness on left side of head and back. Evaluated by EMS-Cleared
48 2021-07-02 feeling hot, tingling, numbness After 1st dose- numbness, pins and needles in my hands and feet lasted on and off the day, emailed m... Read more
After 1st dose- numbness, pins and needles in my hands and feet lasted on and off the day, emailed my doctor to check in about this before getting 2nd dose. They said this was a know reaction and I should get 2nd dose. After 2nd dose- swollen left side of my face, hot, numb feeling. went to ER. was given Steroid and Benadryl. The next morning the swelling went to my neck. And lasted as 3" lump for 5+ weeks. Now has come back as lump when began a small cold- went to the dotcor as this lump lasted 2 weeks- getting ultrasound on neck lump next week.
48 2021-07-02 tremor, tingling Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Anxiety-Severe, Systemic: Shakiness-Mild, S... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Anxiety-Severe, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
48 2021-07-06 migraine, pain in extremity Right after the shot. I got light headed and dizzy. My arm was sore. I was fatigue. My arm had swell... Read more
Right after the shot. I got light headed and dizzy. My arm was sore. I was fatigue. My arm had swell and I had broken out in hives and rash. I had migraine. Flu symptoms
48 2021-07-07 numbness, tingling Patient received dose 2 of the Pfizer COVID vaccine (lot EW0187) at approximately 1445. At 1455, pat... Read more
Patient received dose 2 of the Pfizer COVID vaccine (lot EW0187) at approximately 1445. At 1455, patient reported to Paramedic that she felt generalized numbness, tingling, and lightheaded. PHN approached to assess. Vital signs: blood pressure 162/94, pulse 89, O2 98%, respirations 18. Patient reported eating cereal and a banana. PHN offered patient Benadryl but patient refused. At 1500, PHN and Paramedic assisted patient in transferring to zero-gravity chair and laid patient supine. Patient reported allergy to grass, denied medical conditions and medications. PHN encouraged patient to follow up with provider and when to call 911. Patient reported no history of syncope but experiencing similar reaction to previous injections. At 1505, vital signs: blood pressure 144/86, pulse 80, respirations 16. Patient reported improvement in symptoms. Patient was given juice and goldfish. At 1507, patient reported decrease in pulse, pulse 80. At 1510, patient sat up and reported no symptoms. At 1517, vital signs: respiration 16, blood pressure 132/66, pulse 74. Patient stood up monitored by PHN and Paramedic. Patient left walking with steady gait at 1520.
48 2021-07-07 pain in extremity The moment the nurse injected me, I felt burning down my entire arm and a deep ache. The next mornin... Read more
The moment the nurse injected me, I felt burning down my entire arm and a deep ache. The next morning, I woke up, and the lymph nodes in my neck, clavicle, and under my arms on both sides. I had extreme pain all the way down my spine and was unable to get out of bed for a few days. I messaged my doctor and he offered steroids which I declined because of my chronic conditions. This lasted 2 weeks. Once the lymph nodes finally went down, I was left with pain in the arm and shoulder where I received the injection. Since that time I have lost the range of motion in my shoulder and have seen my Ortho on June 21, 2021 and received a Cortisone shot to help the inflammation to no avail. I am still unable to move my arm without extreme pain
48 2021-07-08 slurring, discomfort, inability to speak I remember clearly that around 11:30AM, I started feeling odd. I couldn't hold my head up. My cowork... Read more
I remember clearly that around 11:30AM, I started feeling odd. I couldn't hold my head up. My coworker found me and said that I was not talking clearly. I was having slurred speech. I wasn't able to get up and walk. I laid down and rest for a while. Someone drove me home because I couldn't even walk or talk. When I got home, my family took me to urgent care. The doctor there told my family that I needed to go to the ER. My symptoms at that time were that I couldn't hold my head up or open my eyes. I was having pain in the upper left side of my body. The doctor ran a CT scan and did some blood work. Around midnight, I started feeling better. My family picked me up and took me back home. The tests came back normal. The next day, I had extreme pain on my left chest area. I had shortness of breath and did not feel normal at all. I went to my cardiologist and he put me on colchicine, a lidocaine patch and a steroid pack. I had to take 10-14 days off of work because of the pain. Every now and then, during that period, I would feel like I was going to pass out. I did not pass out, but I felt like I had to hold on to something. As of today, I have experienced a similar episode, but it went away within a few minutes. I was only ironing my clothes. My main concern is that I get very short of breath, easily and that is not me. This has prevented me from performing my normal activities. I cannot sleep on my right side without feeling discomfort on my left side.
48 2021-07-08 numbness Same day, extreme soreness at injection site, numb fingers, light headed, dizzy, nauseous, vomitting... Read more
Same day, extreme soreness at injection site, numb fingers, light headed, dizzy, nauseous, vomitting, fatigue, metallic taste in mouth. Now twice per week, still experience metallic taste and dizzy spells. Developed vertigo.
48 2021-07-08 migraine Multiple migraines per week, regular medicine taken does not help, at all. Three to four days a wee... Read more
Multiple migraines per week, regular medicine taken does not help, at all. Three to four days a week lost to fighting these migraines which are different from the ones I have sometimes due to the weather.
48 2021-07-08 pain in extremity pursed breathing; muscle ache in scapular area; left arm, that's where the pain is; pain back area; ... Read more
pursed breathing; muscle ache in scapular area; left arm, that's where the pain is; pain back area; pain across the chest area; shoulder pain; pain from her armpit; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 48-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205, Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:00 (at the age of 48 years) single for covid-19 immunization. Medical history included ongoing spina bifida and High blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included Tizanidine (Tablet 4mg) 1 tablet every 8 hours as needed by mouth taken for an unspecified indication, start and stop date were not reported. There was no History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) with no Additional Administered Vaccines list all vaccines administered on same date with the Pfizer vaccine considered as suspect. Patient did not have any Prior Vaccinations within 4 weeks of vaccination. On 09Mar2021 patient experienced pain in left arm, back area and across the chest area - Feels pursed breathing sometime. muscle ache in scapular area. Caller was reporting that yesterday she got her first Covid shot, it was yesterday morning and she was doing fine but she started getting muscle ache. Some muscle ache where shot is but more so across from her armpit to chest area. In her shoulder and mainly across her chest and in the same area on her back. It's gotten worse and worse, and she knows the vaccine can cause muscle pains. It also hurts to breathe in. She reports she has spina bifida and is a wheelchair user. She has had some muscle pain in that area in the past but not like this before. She started to have the muscle ache/pain, soreness yesterday after she received the shot. In the left arm, that's where the pain is. The pain was not like going around from her chest to her back, it's just in her back on that same side in the scapular area. Occurred more so, a few hours afterwards. That was another reason she was calling. Yesterday she took some Tylenol and the nurse that gave her the Covid 19 vaccine said they weren't told NOT to take ibuprofen or anything, she reports that nurse had taken ibuprofen when she got her Covid 19 vaccine, but another nurse was telling her patients, because caller was listening, not to take ibuprofen and to take just Tylenol with the Covid 19 vaccine. Yesterday caller took Tylenol, which is another reason she was calling because she uses a wheel chair and it was hurting so much and for her to be able to get around and everything this morning she took 800mg of ibuprofen and she took her muscle relaxer that she is already prescribed. Commented she probably she should have taken less. She reports the print is so tiny on Covid vaccine card sticker. Treatment: Tylenol 500mg 2 tablets yesterday by mouth and it didn't do anything. Expires May2022 Number provided by caller from bottle 0HV1334. She thinks it's a zero, it has a line through it. Ibuprofen 200mg each, coated tablets. 800mg this morning by mouth. Expires Nov2023 Number provided by caller from bottle. P122941.Tylenol 500mg 2 tablets yesterday by mouth and it didn't do anything. Expires May2022 Number provided by caller from bottle 0HV1334. She thinks it's a zero, it has a line through it. Ibuprofen 200mg each, coated tablets. 800mg this morning by mouth. Expires Nov2023 Number provided by caller from bottle. P122941.While reporting on the COVID 19 Vaccine, caller mentioned details about Tylenol which was used a treatment. yesterday she got her first Covid shot, it was yesterday morning and she was doing fine but she started getting muscle ache. Some muscle ache where shot is but more so across from her armpit to chest area. In her shoulder and mainly across her chest and in the same area on her back. It's gotten worse and worse and she knows the vaccine can cause muscle pains. Caller stated she took Tylenol 500mg 2 tablets yesterday by mouth and it didn't do anything. Expires May2022 0HV1334 (she thinks it's a zero, it has a line through it) she received the 1st dose of the vaccine yesterday morning. She was fine after getting the vaccine, but not until she started having muscle pain from the side of her arm. She got the pain from her armpit and on to her back. She felt like it got worse and worse. The outcome of event pursed breathing was unknown while outcome of the rest of the events was not recovered. No follow-up attempts are possible. No further information is expected.
48 2021-07-08 pain in extremity I received my first vaccin 4/2/21 and second 4/23/21. At the time of each vaccine I had severe injec... Read more
I received my first vaccin 4/2/21 and second 4/23/21. At the time of each vaccine I had severe injection site pain which turned into greater arm and shoulder pain. Pain lasted approximately 4 days each vaccine. In late June I could no longer move my arm, head, neck and was in extreme pain. 10 out of 10. I called my husband's shoulder surgeon and received an appointment 2 days after the call (call on 6/21/21, appointment 6/23/21). I was diagnosed with adhesive capsulitis or "frozen shoulder". I was given a cortisone shot and prescribed physical therapy. After approximately 3 days I was able to move my arm, head and neck again but was still in extreme pain. 8 out of 10. I started physical therapy on 6/28 and as of 7/9 will have completed 4 physical therapy sessions. I have 2 remaining. My pain level is lower, perhaps 2 of 10 and my range of motion is improved.
48 2021-07-08 tremor Feeling unwell; Tiredness; Headache; Muscle pain; Joint pain; Nausea; Chills; Shakiness; Fever of 10... Read more
Feeling unwell; Tiredness; Headache; Muscle pain; Joint pain; Nausea; Chills; Shakiness; Fever of 103.6; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the right arm on 23Mar2021 at 16:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included reflex sympathetic dystrophy (RSD), gastroparesis, excessive factor 8 disorder, lupus anticoagulant, methicillin-resistant staphylococcus aureus (MRSA) carrier, high blood pressure, hypothyroidism, deep vein thrombosis (DVT), upper body blood clots, diabetes, vitamin d deficiency, non-alcoholic fatty liver disease (NAFLD). The patient received other medications (unspecified) within two weeks of vaccination. The patient had known allergies (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient experienced feeling unwell, tiredness, headache, muscle pain, joint pain, nausea, chills, shakiness and fever of 103.6 (unspecified units) on 25Mar2021 at 06:00. The patient did not receive any treatment for the events. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events feeling unwell, tiredness, headache, muscle pain, joint pain, nausea, chills, shakiness, and fever was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-09 inability to speak, slurring TIA (transient ischemic attack) Aphasia Dysarthria Dizziness
48 2021-07-10 pain in extremity arm soreness; hard at the injection site.; This is a spontaneous report from a contactable consumer,... Read more
arm soreness; hard at the injection site.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Mar2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hashimoto's thyroiditis. The patient was allergic to sulfa and erythromycin. Concomitant medications included thyroid (ARMOUR THYROID), fluoxetine (MANUFACTURER UNKNOWN), both taken for an unknown indication and received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 01:00, the patient had arm soreness that started one week after the injection. No rash, but also experienced hard at the injection site. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of arm soreness and hard at the injection site was resolving at the time of this report. No follow-up attempts are needed. Information about lot/ batch number cannot be obtained.
48 2021-07-11 pain in extremity Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise,... Read more
Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Batch/Lot number: EN6206, expiry date was not reported), via an unspecified route of administration in the left arm on 05Mar2021 at 11:45 (at the age of 58-year-old) as a dose 1 single for COVID-19 immunisation. Medical history included asthma, bronchiectasis, CVID (Common variable immunodeficiency) and patient was diagnosed with covid prior vaccination, all from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (singulair), ergocalciferol (vit d), albuterol (salbutamol), doxycycline and fexofenadine hydrochloride (ALLEGRA) taken from an unknown date for an unknown indication. The patient previously took Serevent and had allergy from an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache on 06Mar2021 at 03:30 AM. The patient underwent lab tests which included temperature which was 102.4 and nasal swab which showed negative on 06Mar2021. The adverse events resulted in emergency room or department or urgent care. Therapeutic measures were taken as a result of fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache with breathing treatment (nebulizer), IV steroids and IV. The clinical outcomes of the events fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache was recovered on an unknown date in 2021.
48 2021-07-12 breast pain right breast throbbing pain; right armpit hurt; This is a spontaneous report from a contactable cons... Read more
right breast throbbing pain; right armpit hurt; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6190) via an unspecified route of administration in the left arm on 06Mar2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient previously received penicillin (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient underwent lab tests and procedures, which included COVID-19 virus test on 25Mar2021 and the result was negative. On 13Mar2021 at 12:00, patient experienced throbbing pain in the right breast and right arm pit hurt for 1.5 weeks. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events breast pain and right armpit pain was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
48 2021-07-12 facial pain After the vaccine - three days after - 11th of Jan, I had nausea and tiredness and mild headache. T... Read more
After the vaccine - three days after - 11th of Jan, I had nausea and tiredness and mild headache. The next day, four days after, I had nausea, abdominal pain, diarrhea, slight fever and high blood sugar. I had severe fatigue and severe headache. I felt horrible. I wasn't vomiting. That lasted two days. I did miss one day of work. In June 13th, I had got a sore throat. I had nasal congestion as well as sinus pain - face pain. On the 14th of June, that turned into nausea, fever, chills and that is when in to be seen. She did a chest x-ray. 14th, 15th and 16th, I missed work and I had a letter to go back on the 17th. I had to wear masks and goggles at work so I had a hard time breathing - I had to use an inhaler for two weeks (because I couldn't breathe) so it took my lungs a long time to get better.
48 2021-07-12 numbness, tingling This was my first Covid-19 Vaccine. Within about 3 hours of the injection I began to experience numb... Read more
This was my first Covid-19 Vaccine. Within about 3 hours of the injection I began to experience numbness and tingling in my hands and in the left side of my face. It lasted for about 24 hours. It was significant enough that I had to move my hands continually to be able to use them to grip something firmly.
48 2021-07-12 pain in extremity Pain at injection site. Shooting pain down arm & between fingers. Pain was excruciating. Sensatio... Read more
Pain at injection site. Shooting pain down arm & between fingers. Pain was excruciating. Sensation in the underarm area. . .felt like a lump.
48 2021-07-12 pain in extremity vomiting; dizzy headed; sore arm; This is a spontaneous report from a contactable consumer, the pati... Read more
vomiting; dizzy headed; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non- pregnant female patient, received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 26Mar2021 at 12:30 (at the age of 48-years-old) in left arm as a single dose for COVID-19 immunisation. Medical history included egg allergy. Concomitant medications included methylprednisolone (MANUFACTURER UNKNOWN) and caffeine; paracetamol(EXCEDRIN) all from unknown dates for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 27Mar2021 at 09:00, the patient experienced vomiting, dizzy headed and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vomiting, dizziness and pain in arm were recovering at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
48 2021-07-12 tingling, numbness About 3 hours after the injection I had numbness and tingling in my hands and down my left side. It... Read more
About 3 hours after the injection I had numbness and tingling in my hands and down my left side. It was similar to the response I had to the first injection in the series. It was significant enough that I had to concentrate to grip something firmly.
48 2021-07-12 seizure Immediately felt faint, and passed out within 10 minutes of getting second dose. Appeared to have 30... Read more
Immediately felt faint, and passed out within 10 minutes of getting second dose. Appeared to have 30 second seizure. Paramedics intervened and fainted a second time, and appeared to have another 30 second seizure. Blood pressure and heart rate dropped dramatically. Systolic number was around 40. Transported by ambulance to Emergency Department. Vital signs returned to normal. EKG performed and was normal. Diagnosed as Vasovagal syncope.
48 2021-07-13 tingling 7 days after my 2nd shot, I started experiencing tingling in the feet which progressed to my hands u... Read more
7 days after my 2nd shot, I started experiencing tingling in the feet which progressed to my hands until on May 11th, I couldn't walk on my own and my husband took me to Emergency at Medical Center. They transferred me to other Medical Center that same day where I had multiple blood tests, MRIs, CT scans, lumbar puncture. I spent 8 days there and was transferred to Rehab Facility for 3 weeks. They are pretty sure it is GBS. I am in a wheelchair and have started to use a walker. My fine motor skills are diminished- difficult to type, hold small objects, etc.
48 2021-07-14 muscle spasms I am experiencing lower back pain and muscle spasms she. Standing for longer than 10-15 minutes. I ... Read more
I am experiencing lower back pain and muscle spasms she. Standing for longer than 10-15 minutes. I did not include it in my vsafe check in because it wasn?t constant and I didnt think it was related to the vaccine. It wasn?t until I was making a note of when it started to make an appointment with my doctor that I realized that the first instance was within hours of me getting the vaccine.
48 2021-07-15 hot flush I haven't had a menstrual cycle after I received my second dose. Also, I've had severe hot flashes .
48 2021-07-16 numbness, weakness, tingling, burning sensation Neurological Parasthesis in all extremities, numbness, pain, burning, weakness, cranial neuropathy, ... Read more
Neurological Parasthesis in all extremities, numbness, pain, burning, weakness, cranial neuropathy, falling, itching Fatigue These symptoms have NOT resolved
48 2021-07-16 unresponsive to stimuli, flushing, weakness Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: Patient knelt then lay down on the floor in front of the pharmacy at the end of 15 minute waiting period and said they felt faint and nauseated. was sipping water after the shot. Asked patient if they wished me to call for an ambulance and patient replied that she felt that it would be best to call 911 so we did. Paramedics arrived within 10 minutes of the call and assessed situation and eventually helped patient sit up. Patient stood up on their own and was wheeled out on a chair and exited th
48 2021-07-17 weakness Weakness started after 1st shot on 2/12 but it was not bad. Doctors thought initially maybe myasthe... Read more
Weakness started after 1st shot on 2/12 but it was not bad. Doctors thought initially maybe myasthenia graves, especially given closing of right eye. After 2nd shot, woken in middle of night with terrible sensation up and down spine, and trouble breathing. trouble getting out of bed and terrible weakness in legs.
48 2021-07-17 muscle spasms, tremor, tingling, pain in extremity, electric shock sensation, involuntary muscle movements, discomfort, burning sensation On April 30, 2021, just after 9 am, I received my first dose of the Pfizer COVID 19 vaccine at GVCH ... Read more
On April 30, 2021, just after 9 am, I received my first dose of the Pfizer COVID 19 vaccine at GVCH clinic, in the left arm. Within 5 min, my left arm felt tingly and very heavy 10 min after this, all of my limbs and my lips and tongue felt tingly and heavy. I was immediately transferred to the ER by the nurses at the vaccination clinic. While in transport, my muscles began to spasm and and move involuntarily and I developed a strong headache. I was kept under observation with my heart rate monitored for 3 hours. After 1 hour the muscle spasms stopped and the tingling began to recede in my limbs. I left the ED with the left side of my face and tongue tingling and a headache. On May 4 I awoke up with: swollen finger joints Aching joints throughout body Aching muscles throughout body intense headache (not affected by sound) Tingling in all hands and feet Weakness in all limbs difficulty walking in dark on uneven terrain. I could only walk very slowly everyday objects like my coffee cup felt very heavy. left face and left half of tongue very tingly and "funny" feeling By May 14th tingling, pins and needles in arms and legs from hands to above elbows and knees Parasthesia travelled within a few days from my hands to finally above my elbows, and from my feet to above my knee, like long gloves and socks. The weakness in my limbs became more pronounced left side of face and tongue tingly and heavy (varying in intensity, later realized the intensity is increased proportional by use) low grade headache/pressure above left elbow: pain like a sunburn upon light touch but not with pressure. slightly off balance, wobbly Intermittent muscle spasming, and trembling with overuse (like writing by hand for a few minutes. aching pain throughout limbs, especially upper limbs, as though being crushed shooting pains in hands and feet and other sensory shenanigans. On May 22 Chest muscles and upper back muscles began to feel very heavy, like arms and legs Breathing not affected, but deep breaths feel as if lifting a heavy object on my chest. Ability to sit upright and hold head up for more than 20-30 minutes gone By June 1: barely able to get out of bed but for a few minutes a few times a day. unable to brush my own hair or carry anything heavier than a thin, empty glass. dependent on others for almost everything limbs fatiguing with use to the point of collapse ( I have had several controlled slides down a wall to avoid falling) strength (if you can call it that) is recovered with rest. Pain at a 5-7 out of ten all day, every day. can not be left home alone sometimes lifting food to my mouth requires me to rest. types of pain and sensations: sensations: buzzing as if cell phone on vibrate is on my legs (especially thighs) enough so that I've looked for my phone thinking that was what was happening cold drops of water falling on my thighs sunburn or burned skin sensation in various areas, made painful by cloth or hair touching it sensation of cloth covering skin upon light touch on left arm (injection area) light touch on tops of feet feels overstimulating/unpleasant/not painful but very "loud" as if simply too much sensation wobbly, rubbery, shaky feeling in hands, feet, legs, arms, and neck with use sensation that my joints are wobbly/not attached well/floating paresthesia (above the knee socks, above the elbow gloves) Pains: shooting electric shock pains sensation of burning hot rod puncturing muscles (especially feet) burning sensation especially on feet left big toe feels as if it has a large, bad burn on it. Can not tolerate any touch, can only wear flip flops aching pain in muscles, including neck squeezing/crushing pain in legs and arms sensation of insect sting on legs (actually look for insect each time) (no after effects, just initial jolting/sting sensation headache like a squeezing headband every day since April 30 Using a wheelchair and neck brace to move around and hold myself up to be able to work at all. For the most part, unable to work since May 19th.
48 2021-07-17 night sweats Fever up to 102.3; chills; night sweats; body aches; headaches; very swollen lymph node under armpit... Read more
Fever up to 102.3; chills; night sweats; body aches; headaches; very swollen lymph node under armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 14:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included depression and anxiety. The patient did not have allergies to medications, food, or other products. Concomitant medications included duloxetine hydrochloride (CYMBALTA), lorazepam (ATIVAN), paracetamol (TYLENOL), and ibuprofen (MANUFACTURER UNKNOWN) and cyclobenzaprine hydrochloride (FLEXERIL); all from an unknown date for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 05:00, the patient experienced fever up to 102.3, chills, night sweats, body aches, headaches, very swollen lymph nodes under the armpit. All the symptoms lasted seventy-two hours with the exception of swollen lymph nodes which was on going as of eighty hours. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fever, night sweats, chills, ache and headache was recovered on 27Mar2021 with lasting effects; while that of axillary adenopathy was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-07-17 pain in extremity fever 101.5; fatigue; Headache; Chills; left arm pain from my shoulder to fingers; Nausea; Body ache... Read more
fever 101.5; fatigue; Headache; Chills; left arm pain from my shoulder to fingers; Nausea; Body aches; hazy feeling; This is a spontaneous report from a contactable other health care professional, the patient. A 48-year-old non- pregnant female patient, received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 23Mar2021 at 09:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, hypertension, Inflammatory bowel syndrome (IBS) and migraines. The patient did not have allergies to medications, food, or other products. Unspecified concomitant medications were taken by the patient. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route in the left arm on 03Mar20221 at 11:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 23Mar2021 at 14:00, the patient experienced fever 101.5 (units unspecified), fatigue, headache, hazy feeling (hazy vision), chills, left arm pain from her shoulder to fingers, nausea, body aches. The adverse events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of fever 101.5, fatigue, headache, hazy feeling, chills, left arm pain from her shoulder to fingers, nausea and body aches were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-17 pain in extremity Intense skin sensitivity; intense headache; chills; body aches; could not lift left arm; nausea; vom... Read more
Intense skin sensitivity; intense headache; chills; body aches; could not lift left arm; nausea; vomiting; Dizziness; Bit fuzzy; Tired; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 29Mar2021 at 10:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies, herpes or fever blisters (fever blisters) and anxiety. Concomitant medications included cetirizine hydrochloride (ZYRTEC), triamcinolone acetonide (NASACORT), sertraline hydrochloride (ZOLOFT), aciclovir sodium (ACYCLOVIR), and spironolactone (ALDACTONE) all taken from unspecified dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on 08Mar2021 at 10:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Mar2021, the patient experienced dizziness immediately after vaccine administration of second dose, fuzzy and tired afterwards. On 29Mar2021 at 15:00, the patient experienced chills, intense headache, body aches, and pain in arm (not able to lift left arm), overnight chills increased, and experienced nausea and vomiting. On 30Mar2021, the patient was too nauseous, and had intense skin sensitivity. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events dizziness, bit fuzzy, tired, chills, intense headache, body aches, could not lift left arm, nausea, vomiting, and intense skin sensitivity were resolved on unspecified dates in Mar2021. No follow-up attempts are needed. No further information is expected.
48 2021-07-17 tingling Pins and Needles; This is a spontaneous report from a contactable consumer, the patient. A 48-years-... Read more
Pins and Needles; This is a spontaneous report from a contactable consumer, the patient. A 48-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 25Mar2021 (at the age of 48 years), as a single dose for COVID-19 immunisation. Medical history included Multiple Sclerosis, hypertension, Hypothyroid. The patient was allergic to Macrobid. Medications received within two weeks of vaccination include Synthroid (MANUFACTURER UNKNOWN), Sertraline (MANUFACTURER UNKNOWN), Copaxone (MANUFACTURER UNKNOWN), Simvastatin (MANUFACTURER UNKNOWN) since an unknown date for unknown indications. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, 12 hours after the first dose, the patient experienced pins and needles sensation in random various spots all over the body. The patient had not received any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event pins and needles sensation was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
48 2021-07-18 discomfort patient complained of feeling pressure on her tongue when swallowing post vaccine. Patient given PO ... Read more
patient complained of feeling pressure on her tongue when swallowing post vaccine. Patient given PO diphenhydramine and felt better
48 2021-07-18 feeling hot I had chills, body aches and a fever 16 hrs after the vaccine. I took Ibuprofen 3 times every 6 hrs ... Read more
I had chills, body aches and a fever 16 hrs after the vaccine. I took Ibuprofen 3 times every 6 hrs of 400 milligrams. the area vaccinated was red, hot and very itchy. I had to leave work early.
48 2021-07-18 seizure I woke from sleeping feeling extremely sick and started convulsing non-stop. This went on for over a... Read more
I woke from sleeping feeling extremely sick and started convulsing non-stop. This went on for over an hour. I took Benadryl and it subsided with sporadic convulsions through the night and next morning. I ran a 102 temperature throughout, which was helped a little by Tylenol. Spent most of the next 24 hours sleeping.
48 2021-07-19 numbness LYMPH NODE IN NECK ON RIGHT SIDE SWOLLEN, RIGHT ARM AND LEG GOING NUMB, BLOOD PRESSURE INCREASED HAD... Read more
LYMPH NODE IN NECK ON RIGHT SIDE SWOLLEN, RIGHT ARM AND LEG GOING NUMB, BLOOD PRESSURE INCREASED HAD TO BE PUT ON BP MEDICATION, NOW NECK STILL SWOLLEN AND SWEAT GLANDS ARE CONTINUING TO BECOME INFECTED. BEEN ON CONTINUAL MEDICATION SINCE 4/17
48 2021-07-19 pain in extremity, facial pain Pain in left arm; Pain in neck and head/face on left side; Pain in neck and head/face; Left side has... Read more
Pain in left arm; Pain in neck and head/face on left side; Pain in neck and head/face; Left side has pain and a little throbbing.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 17:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical vertebra injury (yes, I am also experiencing some nerve issues due to damage in cervical vertebrae). The patient had no allergies to medications, food or other products. Concomitant medications included heme iron (MANUFACTURER UNKNOWN), lorazepam (ATIVAN), TYLENOL (MANUFACTURER UNKNOWN) and spiranolactone (MANUFACTURER UNKNOWN); all from on an unknown date for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Mar2021 at 18:00, the patient experienced pain in left arm, also on left side of neck and head or face, pain and a little throbbing on left side but not on right side. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, pain in neck and face, pain and throbbing left side were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-19 pain in extremity My left axillary lymph nodes are swollen, and the swelling is now as big as the size of an egg, star... Read more
My left axillary lymph nodes are swollen, and the swelling is now as big as the size of an egg, starting at about 24h post-vaccine; painful depending on how I move my arm; having trouble sleeping; This is a spontaneous report from a contactable other health care professional. A 48-year-old non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265 and Expiration date was unknown), via an unknown route of administration in left arm, on 11Feb2021 at 17:15 (at the age of 48 year-old), as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had not had COVID prior vaccination and not tested COVID post vaccination. The patient had not received any other vaccine with in four weeks and no other medications were received within two weeks. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247 and Expiration date was unknown), via an unknown route of administration in left arm, (at the age of 48 years), on 19Jan2021 at 17:15, as single dose for covid-19 immunisation. On 12Feb2021, patient left axillary lymph nodes are swollen, and the swelling is now as big as the size of an egg, starting at about 24h post vaccine. The swelling underarm was uncomfortable and painful depending on how she moves her arm, she was also having trouble sleeping because of it and felt limited in her daily activities. Tonight, she called urgent care clinic and was told to go in to be checked out. The patient received no treatment for events, the events resulted in emergency room/department or urgent care. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
48 2021-07-19 seizure, pain in extremity Mother and two sons came to receive vaccines. The sons received their vaccines first, mother went la... Read more
Mother and two sons came to receive vaccines. The sons received their vaccines first, mother went last. Patient completed the consent form and marked that there was no history of chronic conditions, fainting, or seizures. Upon speaking to the mother before her vaccination, she stated that she was very scared of vaccines and needles. We spoke through the vaccine and administered with no issues. The mother and sons were sitting waiting for the 15 minute period when the two sons came to the window and stated that their mom said her arm "felt hot." I immediately grabbed two ice packs and went outside to her. She was leaning back in the chair with her eyes closed but was responsive. I placed one ice pack on her chest and the other behind her head. At this point, the mother began seizing. I asked the boys if this had happened before and they stated that yes, she had a history of seizures. This lasted for approximately 5-10 seconds. The mother came to again and laid with her head back. She too stated that she had a history of seizures. But not after a vaccine before, but that she thinks that the heat in her arm and the pain got to her. She remained sitting for another 15-20 minutes with the ice packs with her feet in the chairs and the fans on her before her husband arrived and she stated that she felt comfortable leaving.
48 2021-07-20 discomfort Significant swelling in axilla; discomfort in axilla; This is a spontaneous report from a contactabl... Read more
Significant swelling in axilla; discomfort in axilla; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 29Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient had no allergies to medications, food, or other products. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) 15 mg weekly, folic acid (MANUFACTURER UNKNOWN) 1 mg daily and ibuprofen (MANUFACTURER UNKNOWN) from an unknown date and for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced significant swelling and discomfort in axilla, it did not seem to be associated with lymph nodes. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event swelling in axilla and discomfort in axilla was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-20 hypersensitivity of all senses Began just after midnight with teeth chattering and cold chills, that progressed to severe exhaustio... Read more
Began just after midnight with teeth chattering and cold chills, that progressed to severe exhaustion, no appetite, entire body aches include headache and skin sensitivity. I basically slept from until roughly 3pm Friday 4/16 and most of the symptoms had disappeared. By 6pm that evening the only thing that remained was a little but of tiredness and reduced appetite. When I awoke Saturday morning I felt fine.
48 2021-07-20 pain in extremity Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injec... Read more
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: patient had severe pain and swelling in arm and sharp pains in neck. Referred her to PCP.
48 2021-07-20 seizure I have had numerous GI issues, constant daily headaches and had a absent seizure last Friday for the... Read more
I have had numerous GI issues, constant daily headaches and had a absent seizure last Friday for the first time in my life. I have also had hormonal issues including inflammed ovaries and cycle changes.
48 2021-07-20 tremor, tingling Aching joints; Swollen and stiff fingers; Swollen and stiff fingers; Strong headache; Pain and needl... Read more
Aching joints; Swollen and stiff fingers; Swollen and stiff fingers; Strong headache; Pain and needles sensation; Left arm felt heavy and tingly throughout/Arms and legs, lips and tongue began tingling, Left side of face has sensation of paresthesia; Body racked with tremors; Dizziness; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered in Arm Left on 30Apr2021 09:00 at the age of (48-years-old) as a single dose for covid-19 immunisation. Medical history included Hashimoto's hypothyroidism from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with covid. The patient was not tested positive for covid after post vaccination. The patient did not have any allergies. Concomitant medication(s) included vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported. It was reported that after 5 min of vaccination patient left arm felt heavy and tingly throughout. 10 min later arms and legs, lips and tongue began tingling. Transferred to emergency room. Upon arrival body racked with tremors, dizziness, and nausea. Tremors lasted an hour and then subsided. Left side of face has sensation of paraesthesia still today (Tues night). On day 5 after vaccination new symptoms are experienced swollen and stiff fingers, aching joints, strong headache, waves of adrenaline rushes. Left side of face unchanged, still pain and needles sensation. The patient was recovered from Tremors. And not recovered from Left arm felt heavy and tingly throughout/Arms and legs, lips and tongue began tingling, Left side of face has sensation of paraesthesia, Dizziness, Nausea, Aching joints, Swollen and stiff fingers, Swollen and stiff fingers, Strong headache, Pain and needles sensation. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
48 2021-07-21 flushing About 3 hours or so after receiving my second COVID (Pfizer) vaccine, I started experiencing facial ... Read more
About 3 hours or so after receiving my second COVID (Pfizer) vaccine, I started experiencing facial flushing, some facial swelling, redness on my chest and some mild swelling of my tongue. The flushing and redness and facial swelling lasted until Satudray May 8th and the swelling of my tongue took about 7 days to completely go away.
48 2021-07-21 pain in extremity Dizziness , muscle pain, itching on parts of body , joints and arm pain.
48 2021-07-22 feeling hot On April 22nd and 23rd, I woke up early that morning and I was very sick, vomiting, and had stomach ... Read more
On April 22nd and 23rd, I woke up early that morning and I was very sick, vomiting, and had stomach pains. I went to the doctor and they did a cat scan. They said I had a bowel obstruction. I started to have diarrhea. The surgeon said it would not be a bowel obstruction. They proceeded to do every test to check. April 23rd, all the test came back negative. I didn't have a fever. After 3 days, I was bale to eat and not throw up stuff. I had diarrhea still. I got discharged from the hospital, and I still had nausea again. The doctor tested me again for C difficle and the test was positive on May 12th. The diarrhea stopped, but I have not been okay since taking the vaccine. I can not eat salads or fresh vegetables because I would start vomiting. I was tested for parasites and that was negative. I had tested positive for a Occult early May . I was scheduled a colonoscopy. It showed I had diverticulosis with moderate severity throughout my entire colon. There is still no real explanation as to why I am nauseous everyday. I have been constantly nauseated and would sometimes have diarrhea ever since taking the vaccine. When I went to mall one day, I was hot and sweaty. I went to the parking lot, and I started throwing up and it was pure bile. I went back to ER and they gave me IV fluids. Now if I take Zofran and Imodium, I am nauseous. I can eat, but still can't eat vegetables. In April and last Friday, my stomach was so bloated I had petechiae on my stomach, but no fever. I have had a little bit of bloating but not as severe when I had took myself to the ER. The last time I went to ER I had a cat scan that was clear except a 2mm kidney stone that showed.
48 2021-07-22 numbness, tingling Tingling in earlobe; numbed jawline; This is a spontaneous report from a contactable consumer, the p... Read more
Tingling in earlobe; numbed jawline; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 09:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included paracetamol (TYLENOL) and meloxicam (MANUFACTURER UNKNOWN), both taken for unknown indications from unknown dates. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 09:30, the patient experienced tingling in earlobe and then numbed jawline. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcomes of the events tingling in earlobe and then numbed jawline were recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
48 2021-07-22 tremor chills; shaking; body aches; joint pain; mild fever; awful headache; felt nauseous; This is a sponta... Read more
chills; shaking; body aches; joint pain; mild fever; awful headache; felt nauseous; This is a spontaneous report from a contactable pharmacist. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP-6955) via an unspecified route of administration in the left arm on 02Apr2021 at 13:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disease. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unknown indication and from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL 3247) via an unspecified route of administration in the right arm on 11Mar2021 at 13:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Apr2021 after receiving the second dose, the patient felt fine initially and went to sleep. On 03Apr2021 at 01:00, the patient woke up with chills, shaking, body aches, joint pain, mild fever, awful headache and felt nauseous. It was lasted all through the day and the patient slept all day. The patient was feeling better at the time of the report. The patient received treatment for the reported events which included tylenol. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events chills, shaking, body aches, joint pain, mild fever, awful headache and felt nauseous were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-22 tremor Irregular, heavy periods post vaccination. Repeat of flu-like symptoms from after second vaccinatio... Read more
Irregular, heavy periods post vaccination. Repeat of flu-like symptoms from after second vaccination: hurt all over, backache, as if a repeat of the second vaccine side effects are linked to menstrual cycle, now. Seem to be coming down, reducing over months, but still significant at third cycle after second vaccine. Also very tired/exhausted most of the time since second vaccine (entire month, regardless of cycle). I also had a systemic allergic reaction to my second vaccine: hives, shaking, dizziness, feeling like was going to faint.
48 2021-07-23 numbness, tingling I got the shot on Thursday, July 22, 2021. I woke up Friday having numbness in my left hand. That w... Read more
I got the shot on Thursday, July 22, 2021. I woke up Friday having numbness in my left hand. That went away and now I have a tingly sensation throughout my left arm. The shot was given me in my left arm.
48 2021-07-23 pain in extremity, hot flush In the first 72 hours: muscle pain, fever, exhaustion, headache, nausea After 72 hours: pain radiati... Read more
In the first 72 hours: muscle pain, fever, exhaustion, headache, nausea After 72 hours: pain radiating down my arm into my thumb to the point I can't bend my wrist without shooting pain. Urinary tract infection, then an ear infection, then a sinus infection. Persistant sores in my gums. Exhaustion. Food tastes strange. Difficulty regulating body temperature--hot flash then chills. Overall muscle stiffness. Daily headaches.
48 2021-07-24 weakness Headache, body aches/joint aches, fever, chills, sweating, weakness
48 2021-07-24 tingling, numbness, flushing Several minutes after receiving the Vaccine, I became flush and felt like I was not going to be able... Read more
Several minutes after receiving the Vaccine, I became flush and felt like I was not going to be able to breathe, however, it only lasted a minute or so and I was fine. The nurse had us stay for 30 minutes rather than the recommended 15 and I was fine and left. Approximately 12 hours after receiving the Vaccine, the left side of my lip/cheek (especially my upper cheek and corner of my mouth felt tingling and became numb. If I had to describe the feeling-It feels as though I've been to the dentist and had a shot of Novocain. 12 hours later my left arm felt/ feels tingly as well through the shoulder and through the underneath of my arm pit area.
48 2021-07-25 pain in extremity Pt called today and reported that her arm has been sore since the day following the vaccine. I reco... Read more
Pt called today and reported that her arm has been sore since the day following the vaccine. I recommended that she contact her primary care.
48 2021-07-26 pain in extremity, migraine, hot flush Patient stated that after the vaccine she was having problems swolling for about 60sec. Arm so sore ... Read more
Patient stated that after the vaccine she was having problems swolling for about 60sec. Arm so sore from shoulder to the risk. Pain felt like it was in the bones. About 10:30pm the caller woke up with extreme hot flashes. Her body was hot and could not get cool. This lasted about one hour and an a half. Patient said she was also having a headache. Patient stated that she was receiving hot fleshes and fatigue on Sunday, Monday, and Tuesday. On Wednesday patient received this extreme migraine headache and out of no where she felt disoriented and a extreme about of pressure in her head and her eye, Patient stated that she was having ringing in her ears. Patient also experience some blurred vision. Patient experienced loose stool. Week of the 14th patient started having these sharp pains in the abdomen and upper sternum.
48 2021-07-27 involuntary muscle movements Day after shot right side of face eyelid kept jumping, index finger on right hand moves uncontrollab... Read more
Day after shot right side of face eyelid kept jumping, index finger on right hand moves uncontrollable by itself, having headaches constantly,
48 2021-07-27 feeling hot Very warm sensation on inner right lower leg that comes and goes. It moves down the leg like a liqui... Read more
Very warm sensation on inner right lower leg that comes and goes. It moves down the leg like a liquid was going down the leg. This happens several times a day, whether sitting, laying down or standing; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 09Apr2021 at 14:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin, sulfur drugs and seasonal pollen. Concomitant medications included probiotics (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced very warm sensation on inner right lower leg that comes and goes. It moved down the leg like a liquid was going down the leg. This happened several times a day, whether sitting, laying down or standing (sensation of warmth). The clinical outcome of the event sensation of warmth was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-27 hot flush, night sweats For the second shot, it was night sweats, dizziness, brain fog, and just disorientation. Then hot f... Read more
For the second shot, it was night sweats, dizziness, brain fog, and just disorientation. Then hot flashes between 1pm- 5pm the next day. THEN I have had nonstop dizziness, disorientation, and some nausea that might be tied to low blood pressure that started right after the 2nd Vax
48 2021-07-27 numbness, tingling shortness of breath; the person that gave her the injection, the shot, that they didn't go inside he... Read more
shortness of breath; the person that gave her the injection, the shot, that they didn't go inside her arm enough so they are saying they didn't stick the needle in, it went in tissue and not the vein; suffered a severe burn with blisters; a lot of pain/ now she's getting sharp pains, bad, terrible; muscle weakness; experienced numbness and tingling; experienced numbness and tingling; discolored and bruised; when she felt it to touch it, it felt like alligator skin; discolored and bruised; local reaction; redness; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 13:00 (Lot Number: EW0158) at 48 years old as single dose for covid-19 immunisation. Medical history included carpal tunnel from 2020 and ongoing (on her left hand, it hasn't been that long ago, 2020, she got a brace), diabetic from Jul2021 and ongoing, ongoing bipolar depression from 2020 (it just became bipolar depression, she's been in the mood stage, she saw a psychiatrist, she was diagnosed within the last year), ongoing asthma from 2019, ongoing osteoarthritis in her back and legs (within the last year and a half), ongoing hypertension/high blood pressure from 2019 (only been a couple years, maybe 2 years), ongoing obstructive sleep apnea from 2017 (its been she guesses 4 years), ongoing GERD/Acid Reflux (maybe 3 or 4 years as well). No vaccines administered on same date with the Pfizer vaccine. Concomitant medication(s) included amlodipine besilate (NORVASC) taken for hypertension (took that the morning of the shot); lurasidone hydrochloride (LATUDA) taken for bipolar disorder (she did have that in her system before the shot); metformin taken for diabetes mellitus (took that the morning of the shot). The patient suffered a severe burn with blisters, a lot of pain, muscle weakness, the day of the vaccine, 19May2021. She got it at approximately 1pm so about 4 hours later that's when she started experiencing numbness and tingling and when she looked at her arm, it was discolored and bruised when she felt it to touch it, it felt like alligator skin. Her nephew picked her up and went to the closest emergency room. Caller stated they didn't do anything, they gave her an ice pack, outlined her arm, and told her it was a local reaction, and she guesses they have seen it before. They gave her a Naproxen for pain and that didn't do anything because she had other issues as well and they stated she should go back for her second dosage which she knew she wasn't going to. The patient discharged herself, basically she walked out of the room. The next day, she went to another hospital and the hospital informed her that the person that gave her the injection, the shot, that they didn't go inside her arm enough so they are saying they didn't stick the needle in, it went in tissue and not the vein. The reaction was so severe that it burned her like she was in a fire. The patient had many pictures, since day 1, she's still taking pictures. As of today, she had a burn on her arm that's never going away. Her doctor, the primary care doctor that she gave, she had to drain the blisters, she had 3 large blisters and the fluids came out. Now she's getting sharp pains, bad, terrible. The blisters are gone now, like she said, she took pictures everyday up until now. She's kind of stopped taking them everyday, but now the medicine she got prescribed, Motrin for inflammation and some type of ointment, she can't remember the name of the ointment, her doctor had her putting it on, none of those things worked, what worked was she bought a aloe Vera plant, that's what helped it get to where it got right now. MOTRIN: patient knew it's a Motrin 600, that's all she knows. Patient confirmed it was in an orange pharmacy bottle. It just says 1 year after disposal date, there is numbers at the top of the bottle. It says Ibuprofen 600mg, take 3 times a day, with food or milk, pharmacy, take by mouth. Patient confirmed name of cream is Aquaphor. Patient stated the symptoms were redness, bruised, painful, burning, blisters and muscle weakness and they all started that day 19May2021. Also the next day 20May2021 is when she went to that second hospital and saw another doctor because she was having shortness of breath with the blisters. They did an EKG and along with a lot of blood work. Patient stated she had shortness of breath anyway because she had asthma but that particular time it was something else going on so that's why she was worried about it. It began 20May2021 that's when she went to the second hospital so early that morning and it lasted through out the day and they said everything was okay. She would say later on that evening, she kind of controlled it, it went down some after she took medicine and stuff, she's on inhalers too. Patient confirmed she has recovered completely. Events resulted in Emergency Room and Physician Office. The outcome of event shortness of breath was recovered on 20May2021, severe burn with blisters and felt like alligator skin was recovered on Jun2021, others was not recovered.
48 2021-07-27 muscle spasms, muscle twitching Twitching; Muscle spasms near the shot site every few minutes; This is a spontaneous report from a ... Read more
Twitching; Muscle spasms near the shot site every few minutes; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the left arm on 02Apr2021 at 15:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease, anaemia, shellfish allergy, cockroach allergy and fruit allergy (allergy to tomatoes). Concomitant medications included sertraline hydrochloride (ZOLOFT), levothyroxine (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (ALLEGRA) all for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 12:00 the patient experienced twitching/muscle spasms near the shot site every few minutes. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event twitching and muscle spasms was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-27 pain in extremity BHRT Symptoms returned early; Arthritis, fibromyalgia and other painmeds stopped working.; Pain in a... Read more
BHRT Symptoms returned early; Arthritis, fibromyalgia and other painmeds stopped working.; Pain in arm; This is a spontaneous report from a contactable consumer, the patient . A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7534) via an unspecified route of administration in the right arm on 18Mar2021 at 13:30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included menopause, arthritis, fibromyalgia, endometriosis, LS, injuries, pinched nerve, lactose intolerant and gluten sensitivity. Concomitant medications included Bioidentical Hormone Replacement Therapy (BHRT)(MANUFACTURER UNKNOWN), celecoxib (MANUFACTURER UNKNOWN), nortriptyline hydrochloride (NORTRIPTYLIN), metoprolol (MANUFACTURER UNKNOWN) and rabeparzole sodium (ACIPHEX), all taken from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021, the patient experienced BHRT symptoms which returned early and arthritis, fibromyalgia and other pain medications had stopped working. On an unknown date in 2021, the patient experienced pain in arm on the third week prior to the second shot. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events BHRT symptoms returned early, arthritis, fibromyalgia and other pain medications had stopped working and pain in arm was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-27 pain in extremity back pain; couldn't stand up; hand felt funny the whole rest of the day on Saturday, the palm of her... Read more
back pain; couldn't stand up; hand felt funny the whole rest of the day on Saturday, the palm of her hand; skin felt tight and heavy; arm was tight and heavy; difficult to walk; painful; This is a spontaneous report from a contactable consumer. This 45-year-old female consumer (patient) reported that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 10Apr2021 (Batch/Lot Number: ER8730) as 1ST DOSE, SINGLE for covid-19 immunisation. (at the age of 48 years). Medical history included sickle cell anaemia from 01Sep1972 and ongoing she has sickle cell and not just sickle cell trait , ongoing drug hypersensitivity reported that she has been told since she was a kid that she is allergic to penicillin , hypersensitivity from an unknown date and unknown if ongoing reported that she is allergic to other medications but did not provide details. The patient's concomitant medications were not reported. The patient experienced hand felt funny the whole rest of the day on saturday, the palm of her hand, skin felt tight and heavy on 10Apr2021 12:30, couldn't stand up on 11Apr2021, painful on Apr2021 (unspecified day). , arm was tight and heavy on 10Apr2021, back pain on 11Apr2021 11:30, difficult to walk on Apr2021 (unspecified day). The caller stated she got first dose of the vaccine on 10Apr2021. Immediately her hand felt funny the whole rest of the day on Saturday, the palm of her hand. Sunday she had the same heavy feeling. Monday when it first appeared midday she couldn't grab anything with her right hand, she could not grab a pen. She stated the skin felt tight and heavy. She couldn't grab or hold or put pressure on her two feet. She couldn't stand up. She could not stand on her legs on the Monday around midday and it just got worse and worse and she could not hold on to anything to stand up. She stayed like that Monday night, and Tuesday it was severe. She could not turn from side to side, it was very very painful. Tuesday night she was thinking she needed to go to the ER but did not want to go and she just asked God to help her. Wednesday she heard people saying their symptoms lasted two days and it started subsiding around midday. Gradually it went away. Thursday she was still sore but was back to her baseline by Thursday. The agent stated she reported her arm was tight and heavy and was having back pain and it was difficult to walk for 48 hours and then she was fine. She stated she says back because it went down to legs and she could not stand on two legs. The patient underwent lab tests and procedures which included computerised tomogram: no blood clot in lungs on 03May2021, troponin: heart was ok on 03May2021.The outcome of the events hand felt funny the whole rest of the day on Saturday, the palm of her hand, skin felt tight and heavy, couldn't stand up was, arm was tight and heavy and back pain resolved on 15Apr2021, Painful was on Apr2021 (unspecified date) and difficult to walk was unknown.
48 2021-07-27 cold extremities High Blood Pressure in the middle of the night 141/101 - night 2 after injection Swollen Armpit Lymp... Read more
High Blood Pressure in the middle of the night 141/101 - night 2 after injection Swollen Armpit Lymph Nodes both sides painful - more so on same side of injection [right arm] day 2 after injection Sore Throat and swollen tonsils day 2 after injection Cold hands/ Feet day 3 after injection Rapid heart rate day 3 after after injection
48 2021-07-28 weakness, numbness, pain in extremity not feeling good; did not sleep and at night; chest pain; pain in the back near the kidney area; Diz... Read more
not feeling good; did not sleep and at night; chest pain; pain in the back near the kidney area; Dizziness; started having pain; I cannot breathe; can't function like this anymore; Pain, by shoulder a 10; Super tired, extremely tired; Pain in the arm, bad/and also my 'thigh on the right'; Arm, described as numb, heavy/Top of body, felt numb/It was bad in the shoulders; Arm, described as numb, heavy; chest is awful/Chest hurt, pressure; feeling weak; nauseous; not normal in my whole body/ Felt awful/ It feels bad; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number and Expiry Date of Pfizer Covid 19 vaccine: Not Provided), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was Not provided, Reason for no lot number: of Pfizer Covid 19 vaccine: Caller unwilling to complete the report) (at the age of 48-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from, she had Covid from Dec2020 (she had Covid over December, and she confirms that it was before she had the vaccine), pregnant, (She only ever had nausea when she was pregnant, a long time ago), nausea (She only ever had nausea when she was pregnant, a long time ago). The patient's concomitant medications were not reported. The patient experienced feeling weak on 24Mar2021, nauseous on 24Mar2021, not normal in my whole body/ felt awful/ it feels bad on 24Mar2021, not feeling good on an unspecified date, did not sleep and at night on an unspecified date, chest is awful/chest hurt, pressure on 24Mar2021, chest pain on an unspecified date, pain in the back near the kidney area on an unspecified date, arm, described as numb, heavy/top of body, felt numb/it was bad in the shoulders on, arm, described as numb, heavy on 24Mar2021, pain, by shoulder a 10 on an unspecified date, super tired, extremely tired on an unspecified date, pain in the arm, bad/and also my 'thigh on the right' on 24Mar2021, dizziness on an unspecified date, started having pain on an unspecified date, i cannot breathe on an unspecified date, can't function like this anymore on an unspecified date. Suspect Product(s): Pfizer Covid-19 Vaccine; Start Date: 16Feb2021. Caller states that she was transferred from two people before us. Spoke for 35mins and 36mins. She's 48 years old and has been having side effects for a week after her first Pfizer COVID 19 vaccine and she's trying to understand why she's "feeling this stuff". She's been feeling weak, nauseous from 24Mar2021 to 27Mar2021, "not normal in my whole body", not feeling good yesterday, did not sleep and at night and her "chest is awful". She's frustrated that we've been asking her questions and not offering solutions. She has asthma, works with kids and has a daughter. She's wondering why she's feeling these side effects and if she needs to go to the ER or wait till morning. She states that she can't go to the ER as she is alone with her daughter and has no family. Caller gave the case number #. From the crosslinked case: Additional to this she mentions that she had chest pain and pain in the back near the kidney area from 9 days now. She has the second dose scheduled on April 21st and is looking for information about the vaccine such as the formulation to write a letter to the (Place name) government so she is not forced to get the second dose due to the reaction to the first dose. She says that she has a daughter, works with kids and has asthma. Age at time of onset of reaction/event: 48 Year. Height (cm): 165. Felt awful, Arm, described as numb, heavy: Date of start of reaction/event: 24Mar2021. Reaction(s)/Event(s) included as Felt awful, Arm, described as numb, heavy, Pain, by shoulder a 10, Chest hurt, pressure, Super tired, extremely tired, Pain in the arm, bad, Dizziness. Additional Context: Caller calling about the vaccine. Reconfirmed with Caller that it was the Pfizer Covid 19 vaccine. Caller said that when she got the vaccine she got paperwork that said that she may have a couple of reactions or side effects for a couple of days. She states, the first two days she felt awful. Caller states her arm, top of her body was not moving and felt numb. It feels bad. The caller said that she had Covid, but the Covid was not as strong. It was bad in the shoulders. Reclarified, that the caller stated she had Covid over December, and she confirms that it was before she had the vaccine. Reclarified, caller reports pain, by the shoulder, out of 1 to 10, it was a 10. Her question is it has been a week and one day, and yesterday she felt awful, her chest hurt, she was super tired, extremely tired, and she has, a history, of asthma. Caller states, the other one is coming soon, clarified as the second vaccine, what will be her reactions, because this one was bad, with the first vaccine. Weight: reports weight as 160 pounds, maybe. Caller states she does not have a healthcare provided. She reports she doesn't have insurance. Adverse Events: Felt awful: Reclarified, Caller states that for the vaccine, you should rest a little bit, but in this country, that she needs to work, she can't recoup, if she feels bad, she has to keep going. Time: caller states she felt it at night. Caller goes on to report that she felt nausea and she felt bad. She said that the pain in the arm started the next day and it was bad. Caller states the nausea she felt at night, she states around 7. She states she was feeling nausea and started having pain, and she only ever had nausea when she was pregnant, a long time ago. She reports that the pain in her arm was for 2 1/2 days, especially the first day. Today is a week and 2 days, since the vaccine, and she is still tired and it was difficult yesterday. Caller also reported pressure in her chest yesterday night. Ongoing: Caller states she is feeling awful, and one day feeling pain in her arm, and for 2 1/2 days, it was very heavy on her arm and feeling nausea on that same day, at night. Caller said that on another day in the morning she also had nausea. Caller said that she has been feeling dizziness and tired now. Reclarified, on 24Mar2021, the same day at night and the nausea was at 7 and the pain in the arm was from the 24-26Mar2021. Arm, numb, heavy: Time: caller states at night. Ongoing: caller states it has completely resolved, maybe Wednesday, Thursday, Friday, Saturday, maybe Sunday. Reclarified, caller states she went to the doctor to check on something else, and it was completely resolved on Sunday. Reclarified, caller states she needs to be at work, and right now she has to be at work and she is driving. Caller states she doesn't want to be in pain anymore. Caller wants to know if she has to go to the doctor, as she can't function like this anymore. Caller was given the option to continue report or be transferred to. Caller states that she doesn't want to take the other vaccine if it is going to be worse, because the reactions are very scary and she has a daughter. Caller states she is just trying to see what is next, and what are the effects, Pfizer needs. Caller states she does not understand what this report is for, because it says on the paper that if someone has information, to call this number. Caller was given the purpose and what it does, as well as the Medical Information Department. Caller states that she has her question, but is this a survey with questions about her reaction. Caller states that she feels uncomfortable about this survey with questions about her health. Caller states she feels intimidated because she is another race. Caller states she told the lady before this call, and she was given this number and held for 25 minutes. Caller was referred to a healthcare provider as a possible resource for her concern. Caller states that she doesn't have one, and she wants to see if this is normal. Caller states she doesn't feel right, with the survey, this morning before work. Caller repeats that she needs to know something about the reactions to the vaccine. Caller states the paper she got with her vaccine says if she had any reactions to call this number, not be a part of a survey if she had an amazing experience. Caller states this is a health issue and it is taking over her and her job. Caller states she has already been talking for 36 minutes. Caller declined to complete report. Full details not obtained. Caller not answering questions directly. Details are as provided by caller with clarifying attempts. Caller notified that Medical Information and/or Pfizer is unable to provide medical advice but may have resources to help answer some questions. Caller spoke very fast and Call Handler asked for multiple clarifications. Caller declined websites. Caller mentioned that in the morning she was on the phone for 40 minutes and was not given useful information for her and she wasted time. Reaction(s)/Event(s) included Last week it was my arm on both of my arm on the right and today nausea and then it went away but it's tiredness. I cannot breathe. I was not sleeping because of my chest, it's my chest and last week it was my arm and also my 'thigh on the right' and today nausea, I am kind of scared to take the next one. Other Products: Not Provided. Consumer stated, "Well, I don't know if you are (incomplete sentence), I mean I got the vaccine (Unspecified Vaccine) last week, last Wednesday and I am 'feeling' weak and I am feeling awful like super weak with nausea two days in a row. I guess it was at work but before this I can easily work and my problem is right now I cannot breathe at all why, I mean it's in my head or (incomplete sentence) but yesterday I was not sleeping because of my chest, it's my chest and last week it was my arm and also my 'thigh on the right' and today nausea and then it went away but its tiredness. I feel super tired, extremely tired and I am just, I couldn't sleep like I have to work, I have a daughter I need so much that I don't rest (Clarification unknown). It never happened to me at all because I never had a vaccine. Well, when I was growing up I was not a sick person, you know. I mean I am kind of scared to take the next one because if I am going to feel like that, I don't know if it is a reaction, it is more than a 'week'. I mean it says you have tiredness or something you have to call on the phone number. What would you do, I don't know because I don't know if I am going to take the second vaccine. I mean I could have worse reaction." When requested for permission to probe questions for a safety report, consumer stated, "No, it's not a right time. I can't talk." LOT: Consumer stated, "I am driving, I mean I have to reach work." Consumer was unwilling to share further information, hence, product details (Expiration date, NDC#, UPC#) reporter type and other details were unknown. Limited information was available over the call. Dates for Pfizer Covid 19 vaccine: (Start: Unspecified Stop: Unspecified). For events, feeling weak, outcome was recovered on 27Mar2021, nauseous, outcome was recovered on 27Mar2021, not normal in my whole body/ felt awful/ it feels bad, outcome was not recovered, not feeling good, outcome was unknown, did not sleep and at night, outcome was unknown, chest is awful/chest hurt, pressure, outcome was unknown, chest pain, outcome was not recovered, pain in the back near the kidney area, outcome was not recovered, arm, described as numb, heavy/top of body, felt numb/it was bad in the shoulders, outcome was recovered on an unspecified date in 2021, arm, described as numb, heavy, outcome was not recovered, pain, by shoulder a 10, outcome was unknown, super tired, extremely tired, outcome was not recovered, pain in the arm, bad/and also my 'thigh on the right', outcome was recovered on 26Mar2021, dizziness, outcome was unknown, started having pain, outcome was unknown, I cannot breathe. outcome was unknown, can't function like this anymore, outcome was unknown. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
48 2021-07-29 pain in extremity Chills; Body ache; Tired; Sore arm; This is a spontaneous report from a contactable consumer, the pa... Read more
Chills; Body ache; Tired; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 06Apr2021 at 14:30(at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient had no known medical history. Concomitant medications included famotidine (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN) from unknown date for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm left on 15Mar2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation and took AFRIN on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of COVID-19 vaccine within four weeks prior to the vaccination. On 07Apr2021 at 03:00 the patient experienced chills, body ache, tired and sore arm. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events chills, body ache, tired and sore arm were recovering. No follow-up attempts are needed. No further information is expected.
49 2020-12-31 weakness mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1... Read more
mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1 day); 3 says after injection: nausea, dizziness and weakness, headache, tiredness, feeling unwell.
49 2020-12-31 tension headache, hot flush 12/26-Had the vaccine, 27th evening felt nauseated, woke up in the middle of the night with head tig... Read more
12/26-Had the vaccine, 27th evening felt nauseated, woke up in the middle of the night with head tightness(headache), rigors, hot flashes.28th feeling off and fatigued, continued to feel better as the days went on and on the 31st had diarrhea, rigors, temp of 99.3F, hot flashes, muscle aches now.
49 2021-01-01 numbness 12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , ... Read more
12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , stinging sensation around eyes, itchy forehead with mild erythema including eyelids, mild circumoral numbness with occasional burning/stinging sensation.
49 2021-01-03 weakness, night sweats Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. S... Read more
Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. Symptoms are ongoing. Also, complaints of insomnia (ongoing), joint pain (day after vaccination), right lower quadrant pain (first night after vaccination), weakness (for 3 days after vaccination), moderate muscle pain at injection site (resolved after 48 hours), night sweats (ongoing).
49 2021-01-03 weakness headache, weakness, brain fog, confusion, dizziness. weakness in limbs
49 2021-01-03 facial paralysis, numbness On 1/3 around 2 am , I got up to get something to eat and drink. The taste of food , feels/ taste li... Read more
On 1/3 around 2 am , I got up to get something to eat and drink. The taste of food , feels/ taste like cotton on the left side of my mouth/ tongue. As the day progress, I noticed I am having numbness left side of my face and mouth, unable to sip from a straw on the left side of my mouth, I am having facial droop that prompted me to to the ER . At ER same day my left eye is not blinking as my right eye. I was prescribed to take antiviral , steroids and eye meds. TODAY- 1/4/21, I am still having same symptoms and my left eye , feels grainy/ needle pricking inside. Left eye vision more blurry.
49 2021-01-03 flushing, tingling Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mou... Read more
Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mouth, prickly feeling to tongue.
49 2021-01-03 flushing I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around ... Read more
I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around the vaccine site. The next morning I had swelling of my hands, feet and legs.
49 2021-01-03 numbness Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency,... Read more
Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency, Hypercholesterolemia and Anxiety with complaints of acute left arm numbness that radiates into her left digits and chest tightness that began 12-13 min after receipt of the COVID-19 vaccine. She noted numbness radiation into the left side of the neck and the bilateral ears. She voices she has also developed chest tightness and wheezing. Evaluated in the emergency department treated with diphenhydramine 25mg, epinephrine 0.3mg and dexamethasone 10mg
49 2021-01-03 pain in extremity pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at tim... Read more
pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at time of injection. Nausea started on 1/4 around 930am. overall fatigue
49 2021-01-03 pain in extremity Intense pelvic/thigh ache started day 2. I still have the ache, but it?s tolerable. I am very fatigu... Read more
Intense pelvic/thigh ache started day 2. I still have the ache, but it?s tolerable. I am very fatigued. Nausea the first two days, with diarrhea.
49 2021-01-03 pain in extremity Very sore arm, required Tylenol Moderate fatigue Sore are resolved next day Fatigue continues
49 2021-01-03 pain in extremity 12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit ... Read more
12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit to wrist. All over fatigue, joint pain, brain fog, and temp of F. Nausea and headache. 12/30 - Pain in left worse, incressed pain, redness, and swelling at injecition site. Painful swollen area in left armpit. Pain with any movement of left arm. Headache, fatigue, nausea, and muscle weakness. 12/31 - Continued pain in left arm, but improved. Continue to have pain swollen area with warmth and redness size of an orange. Headache and fatigue. 1/1 - fatigue, arm sore. Bilateral arm weakness. 1/2 - headache throughout day, not responsive to Tylenol or Advil, fatigue 1/3 - Vertigo, fatigue 1/4 - Left arm slightly sore to touch, fatigue.
49 2021-01-03 tingling Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved ... Read more
Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved by scratching. Left hand rash, of the webbing between the thumb and forefinger, raised. Not as severe as the wrist. Numbness or tingling of the lips, intermittent, first occurred an hour after the vaccine and has been infrequent since then. Gradually reducing in frequency; described as an awkward sensation of tingling. Has contacted her PCP for an appointment. Local Pharmacy would not sell or recommend medications due to the patient's history of Pfizer vaccine without her having been diagnosed first.
49 2021-01-03 tremor, feeling hot, hot flush 10 min after initial injection, I experienced a brief flush of heat that resolved after a few minute... Read more
10 min after initial injection, I experienced a brief flush of heat that resolved after a few minutes. 6 hours later, I had a sudden onset of intense heat, diaphoresis, and a rash to my arms/legs, along with intense muscle tremors, nausea, vomiting and stomach cramps.
49 2021-01-04 weakness difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; ... Read more
difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering. Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-01-04 facial pain, numbness Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue are... Read more
Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue areas. Affects similar to receiving a Novocain shot. No treatment, went away on its own Lasted four hours-was closely monitored
49 2021-01-04 hypersensitivity of all senses, facial pain left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some p... Read more
left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some puffiness; harsh soreness around her both temples and her face; Neck pain; Headache/harsh soreness around her both temples; Feverish; Nausea; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-Year-Old Female patient received BNT162B2 (lot number: EH9899, expiration date: Mar2021) on the 21Dec2020 on deltoid left at single dose to prevent COVID 19. Medical history included Hypertension and Rheumatoid arthritis. Concomitant medications included losartan for Hypertension and hydroxychloroquine sulfate (PLAQUENIL) for Rheumatoid arthritis. She was experiencing a few side effects that are on the list. However, the one that is not on there and she have never had them before. She think that it is something with her left eye there is some puffiness and there is a little bit of swelling and there is a sensation to touch like a little bit of pain when you touch it. It actually started yesterday (22Dec2020) and she took the vaccine two days ago (21Dec2020) and it is on the same side as her injection. So it is on her left side on her left eye and the injection was given on her left Deltoid. It seems to be getting a little better now though the sensation by touch is not as much as it was this morning or yesterday. So she think like it is like going away but it is just something that she think may be should be looked at as one of the possible side effect. She did get neck pain, headache, and bit of headache. She think she was a little bit feverish and nausea and joint pain and a lot of fatigue. She had a harsh soreness around her both temples and her face was like when smile or laugh it was sore. Patient took Ibuprofen to help with the soreness and the pain. It was 800mg. The outcome of the events was unknown.
49 2021-01-04 numbness, tingling I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes af... Read more
I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes after getting the vaccine. Twice while I drove back to work and twice while I was working. These episodes were brief. I also experienced numbness and tingling in my arm that received the injection. This feeling spread to my shoulder and traveled up my neck to my face. I had numbness and tingling on my left side of my face and lower lip. This lasted till about 3:30 pm and then went away. Tonight around 7:00 pm I am still experiencing some numbness and tingling on my face and lip which comes and goes. I am having soreness in my arm at the injection site.
49 2021-01-04 migraine, pain in extremity swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle an... Read more
swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.
49 2021-01-04 muscle spasms, weakness throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it ... Read more
throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it feels like muscle spasms; extremely tired; soreness in her arm; Chills; Nausea; felt weak/having some weakness; massive headache/mild headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 28Dec2020 11:00 on left arm at a single dose for COVID-19 immunization. The patient was positive for Covid back in Jun2020, it was a bad case that she was hospitalized for 6 days, that she did not have to go on respirator. She stated these days she still struggled with chest pains and still struggled with her taste, she went to the emergency room in Sep2020 with some issues from that. The patient concomitant medications were none. The patient stated she was retired who works security at a hospital that she got her first dose of the Pfizer Covid vaccine yesterday on 28Dec2020. She was calling to report some side effects from the vaccine. She was skeptical about shot but she went ahead and got the vaccine, she took it and waited the 15 minutes and everything was fine except some soreness in her arm, about an hour after the shot, she felt extremely tired, could not even read, by last night she was getting chills, nauseated and weak, all she wanted to do was sleep, she had a massive headache. She kept thinking she was going to have to go to the ER. She woke up this morning and her throat was sore, felt like it may be swelling, felt sick. She took two advil and her headache was better. She was taking tumeric and ginger root and honey with lemon for her throat. She knew she was not sick that it is just the vaccine and she would power through it but wanted to call. She was starting to feel better but still having some weakness, still tired, had pain in the arm of the injection site, a mild headache. She stated these side effects are still ongoing but are improved. She was also having some neck pain started this morning sometime, but does not know exact time, it feels like muscle spasms. Caller wanted to know if because she had Covid before her side effects are so bad. The patient did not do any relevant tests. The outcome of the events soreness in her arm, extremely tired, Headache was recovering, the outcome of the events Chills, Nausea was recovered in Dec2020 and the other events was not recovered.
49 2021-01-04 pain in extremity, breast pain ON 1/1/21, DEVELOPED SWELLING ON UNDERSIDE OF LEFT ARM. DISCOMFORT IN THE AREA AND PAIN RADIATING TO... Read more
ON 1/1/21, DEVELOPED SWELLING ON UNDERSIDE OF LEFT ARM. DISCOMFORT IN THE AREA AND PAIN RADIATING TO HER LEFT BREAST. ON 1/4/21, STATES THAT THE SWELLING IS RESOLVED AND THE PAIN IS IMPROVING, BUT STILL PRESENT IN THE LEFT BREAST.
49 2021-01-05 feeling cold I had the vaccine on the 23rd December I was monitored for 15 mins. My throat felt scratchy and itch... Read more
I had the vaccine on the 23rd December I was monitored for 15 mins. My throat felt scratchy and itchy, I left at 3pm by 3:15 my head started hurting, mild. at 7pm I had a pounding headache, chills, body aches on the 24th AM I could not warm up my body was shivering I went to work at 8 am I thought I had a fever and I checked it was 100.2 when I got home my temp was 101 and 102.9 and my body aches were horrible I couldn't move nausea no appetite, shortness of breath, I did a telemed and talked to my primary and she said this was all related to the vaccine, she prescribed something for the nausea was asked to get a covid test and it came back negative, I started getting better Dec 27th .
49 2021-01-05 feeling hot THROAT TIGHTNESS, FINGERS WARM. EPI GIVEN. TRANSFERED TO ER
49 2021-01-05 flushing, pain in extremity, tremor, cold extremities, feeling hot I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was si... Read more
I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was sitting on my arm and very heavy at the site. I went to the waiting area and the last 5 minutes and I started feeling weird, kind of getting dizzy and my heart started racing really fast. Am I can tell I was getting really hot and my face was flushed and my heart was racing and my hands started shaking, trembling almost like I couldn't control it. I've never experienced something like this. The part that really scared me was my heart racing like it was going to come out of my chest. They called a code, put me in a wheel chair and took me to the ER (where I work). They took my blood pressure which was really high, they did EKG, blood work and urine test. They kept me there for about five hours, while watching me. And the last weird thing that happened at one point I felt like liquid was running thru my body and my feet were really cold for several hours, It felt like someone was pouring liquid over me. I kept asking the nurse if this is normal and no one knew what to tell me. After everything started slowing back down and it had been a couple hours and the next day i felt like I had a slight head ache and felt out of it, kind of like I had a hangover and of course my arm was really sore. The Doctor in the ER did advise me not to get the second dose as it will be worse than the first one.
49 2021-01-05 flushing A couple of hours after the vaccine, I began to have extreme muscle pain, both in the left arm and i... Read more
A couple of hours after the vaccine, I began to have extreme muscle pain, both in the left arm and in my other arm, back. I became extremely fatigued and felt lethargic. I felt flushed and slightly nauseated, but mostly I felt body pain and extremely tired. This continued through the evening and night. In the morning of 1/6/21, I felt better, but today I still have severe muscle pain in both arms and shoulders and back and neck and I am still fatigued, with some loss of appetite.
49 2021-01-05 migraine, tingling, hot flush UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to... Read more
UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to a previous flu vax reaction 2 years. She did consequently have a migraine headache upon awakening this AM which prevented her from working. Treated with Benadryl 25mg PO in the ER, monitored via cardiac monitor and then she was discharged with 25mg of Benadryl that she took when she got home at 1630.
49 2021-01-05 night sweats Night sweats followed by chills and rigors, followed by severe headache and nausea/vomiting from 2AM... Read more
Night sweats followed by chills and rigors, followed by severe headache and nausea/vomiting from 2AM on 1/5/2021 to 0730 1/6/2021. Massive headache still lingering.
49 2021-01-05 pain in extremity Chills,joint pain,muscle aches,nauseated, headache, sore arm
49 2021-01-05 tingling, flushing, numbness, pain in extremity After receiving the injection in the right arm, the patient began to feel pain and burning at the in... Read more
After receiving the injection in the right arm, the patient began to feel pain and burning at the injection site in the right deltoid with spreading down to her hand along with localized redness at the injection site. She was given 50 mg of diphenhydramine and subsequently developed facial flushing and a feeling of numbness/tingling in both arms and hands. At this time, about half an hour had elapsed after the injection, so she was referred to the hospital emergency department from the hospital vaccine pod for additional monitoring. No additional interventions were given in the emergency department, she was discharged home after 3 hours of monitoring. Symptoms had improved with time.
49 2021-01-06 weakness Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad... Read more
Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad (Still having some of these problems)
49 2021-01-06 weakness Patient reported weakness and pain in neck and back
49 2021-01-06 cold sweat, migraine, feeling hot This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vacci... Read more
This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vaccine recipient reported that after 10 minutes of receiving the 2nd vaccine they developed a headache that felt like a migraine. The vaccine recipient took Advil, then a few minutes later started sweating, felt clammy, and hot. The symptoms started to pass 15 minutes later. That night they reported that their chest felt tight but it went away before bedtime. This morning 1/7/2021, vaccine recipient reported feeling tired and mind felt foggy. They were able to continue to go to work.
49 2021-01-06 feeling hot, flushing a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This ... Read more
a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This is a spontaneous report from a contactable Nurse(patient). This Nurse reported for similar events for 6 patients. This is 1st of 6 reports. A 49-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at the 49 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The registered nurse and 5 other registered nurses she worked with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after she was injected with the COVID-19 Vaccine. She had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. The patient said she had no other symptoms after receiving the COVID-19 Vaccine. The reporter said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. The reporter said stated the registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter stated she did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. The patient works at a hospital but didn't received any medical treatment. The patient just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. Case will be reevaluated based on follow-up information ,Linked Report(s) : US-PFIZER INC-2021001363 same reporter/drug/event, different patient.;US-PFIZER INC-2021001364 same reporter/drug/event, different patient.;US-PFIZER INC-2021001195 same reporter/drug/event, different patient.;US-PFIZER INC-2021001204 same reporter/drug/event, different patient.;US-PFIZER INC-2021001329 same reporter/drug/event, different patient.
49 2021-01-06 feeling hot Today was my second dose of the COVID vaccine and just a few short minutes after the injection the i... Read more
Today was my second dose of the COVID vaccine and just a few short minutes after the injection the injection site start itching. At just about the 15 min wait time after ionjection a nurse asked if i was feeling ok. I told her i was feeling gine but my arm was very itchy. She checked the site and I had redness all around the site and welt size hives around the site. She asked me to stay 15 min longer and I agreed. Shortly after that the hive started to spread to my neck and chest area and I became lightheaded and faint feeling. I became very hot. They gave me and injection of benadryl and since my BP was high and my syptoms were not going away completly I was taken to the ER for monitoring and IV fluids. There I was given more Benadryl, steroids, Pepcid and IV fluids and monitored. I felt much better and was released to go home with a RX for 4 days of steroids.
49 2021-01-06 feeling hot Patient sitting for about 20 minutes and feet felt hot/on fire; no shortness of breath. BP 118/84; p... Read more
Patient sitting for about 20 minutes and feet felt hot/on fire; no shortness of breath. BP 118/84; pulse 84; p ox 99%. Has had same sensation when had allergic reaction to bactrim. Monitored for another 15 -20 minutes; took gatorade. Wanting to go home and take liquid benadryl.
49 2021-01-06 flushing, feeling hot she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Ta... Read more
she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 6th of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. The registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter did not know if the patient received any other vaccines at the same time as the COVID-19 Vaccine, and if had received any other vaccines within the last 4 weeks. The patient works at a hospital but doesn't believe that she received any medical attention. she believed just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported whole body heat, flushing, tachycardia and palpitations, and the administration of BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
49 2021-01-06 flushing SkinRash flushed face noted with rash around neck Narrative: @1348 noted face flushed and rashes aro... Read more
SkinRash flushed face noted with rash around neck Narrative: @1348 noted face flushed and rashes around neck. BP 132/80, P 96, R 18, O2 sat 100%, T 98.6 Given Cetirizine 10 mg po and observed for 30 minutes. @ 1405 BP 123/65, P 65, R 18. Resolved and d/c'd at 1410. Updated in employee record on database
49 2021-01-06 flushing 12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed... Read more
12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed headache, 3pm developed nausea, vomiting and dizziness, flushing of skin. Rapid Response called at 3:52pm and patient sent to Emergency Room at 4pm. VS on arrival were BP 144/105, HR 146, RR 22, T 97.9, O2 sat on Room air 98%. ED treatment included IV of 0.9NS (1L), EKG, IV Zofran 4mg, IV Benadryl 25 mg, IV Ativan 0.5mg, IV Compazine 10mg. Also had CT head.
49 2021-01-06 numbness, flushing, tingling felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, al... Read more
felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, also hands flushed feeling over neck facial numbness on the left check headache dizziness neck pain throat pain numbness and tingling on right arm fatigue feels unwell
49 2021-01-06 numbness, tingling Patient reports arm became numb right after receiving the COVID-19 vaccine. Two hours later patient ... Read more
Patient reports arm became numb right after receiving the COVID-19 vaccine. Two hours later patient reports the numbness being limited to the bottom of the arm and hand. Patient states to being able to use hand but reports there is numbness and tingling.
49 2021-01-06 migraine About 1.5 hours after injection: migraine, bad sinus pressures, major fatigue and chills. All sympt... Read more
About 1.5 hours after injection: migraine, bad sinus pressures, major fatigue and chills. All symptoms lasted about 22 hours. I still have a minor headache and fatigue
49 2021-01-06 pain in extremity Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm... Read more
Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm soreness, chills, and hives/welts on her face, neck, back, and thighs. The associate is taking Benadryl and self-monitoring her symptoms currently from home. The associate was instructed to seek medical attention if symptoms worsen.
49 2021-01-06 pain in extremity Headache, Myalgia, ARM PAIN,CHILLS,LIGHT HEAD Narrative:
49 2021-01-06 pain in extremity 9 x 5 cm area of raised redness and pain left arm starting on on day 8
49 2021-01-06 tingling, numbness Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of ... Read more
Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl.
49 2021-01-06 tingling, numbness Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the l... Read more
Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the lft side, especially on the cheek, coming from neck. Back of head. numbness and tingling feeling on the back of the head and both arms and the hands. Patient reports headache as well. Also feeling fatigued
49 2021-01-06 tingling, numbness Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dos... Read more
Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl. Patient reported feeling better and was sent home.
49 2021-01-06 tingling, pain in extremity, weakness Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, g... Read more
Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, generalized weakness Narrative: employee considered response mild, needed a heat pack for pain relief, staying in bed on Jan 5. Taking 800 mgm ibuprofen every eight hours, has not recovered yet.
49 2021-01-06 cold extremities, weakness Fever, chills, feet felt frozen-Sat day & evening w/ABD pain Exhausted-she slept, next day Sunday@02... Read more
Fever, chills, feet felt frozen-Sat day & evening w/ABD pain Exhausted-she slept, next day Sunday@02 or 03 sleeping clothes all wet-she had to change her clothes, Sunday-she feels drained, She laid in bed Saturday & Sunday drank water and took Motrin. Monday-too weak to work. Body aches, headache. Monday severe ABD cramps-heating pad to help/nauseated. Tuesday diarrhea starts. Wednesday-left side of her back-pain-diarrhea & Tired. No SOB. Drinking Pedialyte and taking Motrin-she said IF she gets worse she will go to the Urgent Care-near her home.
49 2021-01-06 tremor Fever, chills, shaky
49 2021-01-07 weakness Chills with goose bumps, headache, severe aches, weakness/fatigue which began ~ 7 hours after inject... Read more
Chills with goose bumps, headache, severe aches, weakness/fatigue which began ~ 7 hours after injection and progressively worsened over 24 hours, ~40 hours after injection symptoms were gone. -took advil, increase fluids and went to bed to sleep ~ 7 hours
49 2021-01-07 feeling hot, migraine 100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is ver... Read more
100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is very painful; migraines; she felt warm; joint pain; dull headache; tenderness at the injection; chills; as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it; fatigue/joint pain and fatigue are getting worse; This is a spontaneous report from a contactable consumer. A 49-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on the left arm on 30Dec2020 10:40 at single dose for covid-19 immunisation. Medical history included from Feb2020 and ongoing she is currently a breast cancer patient/she had breast cancer, has lymphedema in the right due to breast cancer and on 31Oct2020, she tested positive for COVID and that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. Had joint pain and fatigue ever since her COVID-19 diagnosis in October. There were no concomitant medications. The patient previously took H1N1 shot and her arm got really big and they watched for cellulitis discomfort. The patient stated on Dec2020, "received the COVID-19 vaccine on 30Dec2020 and is reporting 100.7 temperature, dull headache, tenderness at the injection, chills, joint pain and fatigue. She reported that she has had joint pain and fatigue ever since her COVID-19 diagnosis in October. The patient contacted COVID, she tested positive on 31Oct2020, and still has no taste or smell, and the biggest thing right now, that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. She wants to know, where it has gone into the joint, the arthritis has flared from it, from her testing positive, it will be 9 weeks tomorrow since she had COVID, and she is not 100%, and yesterday she had the COVID vaccine, her first dose, and she was up all night, her joints and muscles were in a lot of pain, but she had been like that, and this morning she took her temperature and it was 101.7. Does it mean can't have the shot in 3 weeks? She has had health issues this year, she had breast cancer, and her oncologist wanted her to have the vaccine, but it concerns her with all the pain in her joints swelled, and wanted to know if it is a side effect due to COVID. States she is still coughing, she wants to know if Pfizer thought this was a side effect of COVID, since she tested positive in October, will she have to live like that? It is very painful. Her shot went fine at 10:40 yesterday morning, fine, but she has been experiencing stiffness and joint pain, and she contacted COVID in October, thinks this doesn't have to do with the shot, this has been this way since October, and her husband said to ask- will it be like this since she contacted COVID, and the only thing, this morning she had a headache, but she didn't sleep and she gets migraines it she doesn't sleep, and she took her temperature, she felt warm and it was 101.7. Her temperature was 101.7 about a half hour ago (31Dec2020), she takes her temperature now, states it is now 100.8. Stated that she probably needs to speak to her doctor for her questions. Got up a 1am and took Ibuprofen. Her joints were so sore from when having COVID and so she went back to sleep and slept off and on. Got up at 4am this morning with the dull headache, it was not enough to be considered a migraine, so she took another 800mg Ibuprofen. Headaches: states it is just a dull headache, she hasn't taken Ibuprofen yet this morning, she is not a big medicine person, she is trying to see if it will go away, but if it is worse she will take migraine medicine". The outcome of "as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it", "she was up all night/she didn't sleep", "It is very painful", "migraine" and "she felt warm" were unknown. Other events was not recovered.
49 2021-01-07 feeling hot Throat hurting , really hot Neck Swollen , back of Neck hurt really bad Joint Pains Headache
49 2021-01-07 flushing Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12... Read more
Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12 hours. All symptoms resolved. Patient Included the following information: 1 st dose Phizer EH 9899 2nd Dose Phizer EK 9231
49 2021-01-07 numbness, tingling Left sided parentheses and numbness sensation which then spread to right side. Strong headache initi... Read more
Left sided parentheses and numbness sensation which then spread to right side. Strong headache initially then resolved, rapid heart rate, confusion, dizziness, high blood pressure,
49 2021-01-07 pain in extremity, discomfort, feeling hot EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, ... Read more
EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, she felt warm but she had a coat on and her eyes started to hurt and she felt tired but she works night shift. She felt this was normal for working the night before and having stayed up to get the vaccine. After her wait period she went to her car and remembers feeling warm for having to walk in the cold. Her right side of face became reddish purple and warm. She sat in car for a few minutes. As she drove her face started to swell and turn all red. When she arrived home she had heavy pressure middle of face-nose area. Her face continued to turn reddish purple with a rash on right side of face and down to her neck. She felt her sinuses and throat swell with irritation and in throat and wheezing. Her mom is a nurse and they waited to see if it worsen or got better. She decided since she could breath she would not go to hospital. After about 5 hours she felt much better. She continued to have a headache for 4 days. She had swelling and soreness of left arm for a couple of days. She continued to go to work.
49 2021-01-07 pain in extremity fever of 2-3 degrees; slept most of the day; didn't feel well at all; headache; achey; tired/exhaust... Read more
fever of 2-3 degrees; slept most of the day; didn't feel well at all; headache; achey; tired/exhausted; sore arm; woke her up briefly; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included spending 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. The patient has no known allergies. The patient has no covid prior vaccination, and she was not tested for covid post vaccination. The patient's concomitant medication included multivitamin. The patient did not receive other vaccine in last four weeks. The patient was vaccinated on 31Dec2020 at 10am for her 1st Pfizer vaccine. No symptoms for 6-8 hrs. By bedtime at 06:00 PM, she experienced headache, achey, tired, and sleeping on her sore arm woke her up briefly. Next day on 01Jan2021, more achey, exhausted, fever of 2-3 degrees, slept most of the day and didn't feel well at all. She could tell that her body was fighting something, but she is much better 48 hours out. The patient did not receive any treatment for the reported adverse events. She stated she had no regrets. She stated that she loves Pfizer, because it has given hope. She just wasn't expecting any side effects after the 1st vaccine, only for the 2nd. Anecdotally, it seemed her hospital coworkers who have had Covid react more to the 1st vaccine, possibly for them, 1st vaccine is like the 2nd. She doesn't know if she has had Covid, but as an Acute Care PT on Covid units, she spends 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. She stated that possible her immune system already recognizes Covid. She is curious. No complaints, only curious. Again, she said thank you. She stated that she has seen too many good people die this year, thus, she didn't hesitate on the vaccine. The outcome of the events was recovered in Jan2021. The report was considered non-serious. Information on the lot/batch number has been requested.
49 2021-01-07 pain in extremity 01/08 sent email to cancel the second dose. I called her and she states after the first dose after ... Read more
01/08 sent email to cancel the second dose. I called her and she states after the first dose after about 1.5 hours started getting tachy and palpations for about 6 hours following her shot. She states her resting HR was HR 130 for about an hour but she just sat and waited it out. She denies going to ER or calling she stated she had this happen about 6 years ago and just waitied it out. She stayed and worked stating she just did inservices and after about 6 hours felt better before she states she felt fine the next day except for sore arm.
49 2021-01-07 pain in extremity I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in ... Read more
I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in armpit lymph nodes was the size of a very large egg. I couldn't comfortably put my arm down at my side. Pain radiated down arm to elbow, and up neck into ears. I had fever of 100.1, but took ibuprofen to try and alleviate pain. The symptoms lasted about 5 days.
49 2021-01-07 pain in extremity Nausea, Headache, Fever, Sweats, Sore Arm
49 2021-01-07 tingling, flushing developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-1... Read more
developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-19 vaccine. By the time of assessment in ED, sxs have resolved other than residual numbness of lips.
49 2021-01-07 tingling Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/1... Read more
Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/112. tachy at 101. patient brought to ED for further evaluation.
49 2021-01-07 tingling Fatigue; She said it felt like painful poking/"needle pokes" on the inside of her left elbow and the... Read more
Fatigue; She said it felt like painful poking/"needle pokes" on the inside of her left elbow and the inside of her left wrist; "Needle pokes" on the inside of her left elbow & left wrist. She said what she was experiencing was like pins & needles, but with just the needles.; This is a spontaneous report from a contactable consumer (ophthalmic technician, also patient herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 29Dec2020 11:44 at single dose on her left upper arm (non-dominant arm) for COVID-19 immunization. Medical history included ongoing lupus from 1993. The patient had no concomitant medications were received. No additional vaccines administered on same date. No emergency room and physician office were visited. The patient had no prior vaccinations (within 4 weeks). The patient took part in a COVID-19 Vaccine program and had fatigue as a side effect. She received the COVID-19 Vaccine on 29Dec2020 at 11:44AM. Reported she started experienced fatigue at around 7:00-8:00PM. She said she all of a sudden became really tired, like she hit a brick wall. She said she could still do stuff, but was really tired. She said the fatigue lasted about 24 hours. She said she generally experiences fatigue in winter, but this fatigue was more than the usual fatigue. Reported she also experienced "needle pokes" on the inside of her left elbow and the inside of her left wrist. She said what she was experiencing was like pins and needles, but with just the needles. She said it felt like painful poking, but the pain was not severe and only lasted a half hour. Reported she recently had full blood work done with her primary care doctor, and all was fine. She said she also had some testing done with her gynecologist, and all was fine, saying there was nothing weird. The patient declined any treatment. The outcome of the event fatigue was recovered on 30Dec2020. The outcome of the event She said it felt like painful poking was recovered on 29Dec2020. The outcome of the rest event was recovered in Dec2020.
49 2021-01-08 inability to speak, weakness Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphor... Read more
Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphoresis, then unable to stand, fell to the floor then could not see at all, everything was black, also unable to speak, sudden onset of shortness of breath, central chest pain, pain to shoulders and neck. Ears ringing, pain to back of head. Approximately 15 min later was able to speak and crawl to edge of bed. Sweating remained at this time along with extreme weakness, lightheaded and nausea. Heart rate 118, oxygen was 96% by finger oximeter. 10 minutes later dressed with assistance and able to ambulate independently but slowly to truck to be taken to ER.
49 2021-01-08 weakness 01/08/21: Sudden onset of extreme body/muscular pain, such that moving was difficult. Extreme chills... Read more
01/08/21: Sudden onset of extreme body/muscular pain, such that moving was difficult. Extreme chills, headache. Needed pain medicine to alleviate pain. Fatigue. 01/09:21: AM: Less body pain , but feeling of heaviness in head; weak. PM: Had onset of lower GI symptoms: painful abdominal/cramps, stomach pain, nausea. No vomiting, but had several episodes of diarrhea. Feeling like passing out but never did. Loss of appetite. Slowly resolving.
49 2021-01-08 feeling cold After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light ... Read more
After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring. I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest. Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure
49 2021-01-08 feeling hot, flushing Heat/flushing from injection site to neck to face to upper body x 20 minutes; sweating
49 2021-01-08 feeling hot Headache chills, feels hot (no fever), body aches, stuffiness, and headache
49 2021-01-08 feeling hot Fever Narrative: Employee woke with a 102.1 fever this morning. States she feels hot but no fever ... Read more
Fever Narrative: Employee woke with a 102.1 fever this morning. States she feels hot but no fever or chills or any other symptoms ofUpper Respiratory illness. Has not taken Ibuprofen or Tylenol.
49 2021-01-08 migraine Day one I had a headache. Wouldn?t go away with any medication. Day 6 still had headache turned into... Read more
Day one I had a headache. Wouldn?t go away with any medication. Day 6 still had headache turned into migraine and severe exhaustion. Chills, diarrhea and nausea. Day 10 woke up in the middle of the night with fever 99.6. At this point I went and got tested for Covid and it was negative. Finally on 09/09/2021 woke up without a headache but it came back later on.
49 2021-01-09 migraine Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had... Read more
Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had swelling and a red lump at site of injection, with pain and soreness around injection site.
49 2021-01-09 pain in extremity, paralysis The patient received the vaccine in the left deltoid at 07:45 on 1/7/21. The patient reports that o... Read more
The patient received the vaccine in the left deltoid at 07:45 on 1/7/21. The patient reports that on 1/8/21 at around 0200, she was awoken with a sharp pain in her left arm followed by complete paralysis of her left hand for about 15 seconds. Did not re-occur. Did not seek treatment. Reported to Dr. and no further issues seen.
49 2021-01-09 pain in extremity Approx 10 hrs after injection severe left arm pain, progressed to all over body aches about 12 hrs p... Read more
Approx 10 hrs after injection severe left arm pain, progressed to all over body aches about 12 hrs post vaccination. Approx 24-30 hrs post vaccination chills and slight headache added and remained until approx 48 hours post. Took Motrin for aches and rested with restricted movement
49 2021-01-10 feeling cold chills exhaustion, headache
49 2021-01-10 feeling hot Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotte... Read more
Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotten a CT contrast, where my whole body began to feel warm, also a metallic taste in my throat. A few hours later I had a horrible headache, with tightness in my chest and palpitations. My muscles and joints ached, my hands became swollen and I was unable to remove my ring. These symptoms continued for 24 hours. I also experienced shortness of breath.I almost took myself to ER. They eventually went away and I feel fine now
49 2021-01-10 muscle spasms ABDOMINAL PAIN, CRAMPING
49 2021-01-10 speech disorder, feeling cold her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all ... Read more
her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all sick, cold, sick and experiencing terrible side effects; Fatigue; Muscle ache; Nauseous; Felt awful; Can't eat all the day, no appetite; phobic something to drinking water; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. The patient experienced getting all sick, cold, sick and experiencing terrible side effects, fatigue, muscle ache, nauseous, cannot do anything, felt awful, cannot eat all the day, no appetite, phobic something to drinking water. The patient has been sick for three days now. The patient was a "senior" (not clarified) care giver at the nursing home. Everybody at nursing home at the nursing home got the shot and now everybody has cold and sick. She has only one day of work and she has to come into her job to take care of elderly people. As since current everybody is experiencing the terrible adverse, terrible side effects, everything. Fatigue, muscle ache everything. The bosses at her nursing home cannot give them three days or even seven days off of work after receiving a contract to give them shot. It was confirmed that the patient received the COVID vaccine. The patient also stated that they are off of that side effects. They are not interrupted not just the "arm" (not clarified) been there. The patient said she getting everything. She was getting all the side effects. So when they had this Pfizer drug shot "they didn't get seven days off of" (not clarified) work. If a person gets a shot, they are feeling fatigue, nauseous (incomprehensible voice). They can't do anything. They should be allowed to stay home from work. Right now everybody in the nursing home is feeling the adverse effect. The entire building. So, she was telling Pfizer to report the report is that all of sudden that the nursing home "seniors" (not clarified) and nurses they got the shot, they can't even get to work. The effects are so bad that they can't do anything. The patient also stated that fatigue, she had fatigue all day. The first day she got the shot her nerve was bad but the second day was everything fatigue. She felt awful, she could not eat, she had no appetite. She was phobic something to drinking water, she cannot eat all the day. "Fruit or something 5 I can eat" (incomprehensible voice)." When probed for the LOT#, the reporter stated, "No they did not give me anything. All they did is I think 037 I think it looks like a 'K' 20A. (further not clarified) like it says (further not clarified) 037K20A that's (further not clarified)." The outcome of the events was unknown. Information on lot number/batch number was requested.
49 2021-01-10 tenderness After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mi... Read more
After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mild headache that was intermittent. I had malaise and fatigue. I took some cold medicine 3 times in the course of 24 hours and woke up the next morning with none of those symptoms but did have lympadenopathy under my left arm that decreased through the course of the day. It was painful to touch and tender once the lymph node decreased in size. The only other reaction was the site pain and tenderness and warmth. That lasted a few days.
49 2021-01-10 tenderness Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injecti... Read more
Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injection administered. Fatigue and headache occurred by the same afternoon and low grade fever of 99.6° that evening at 8:30 PM. Right armpit tender and swollen lymph nodes remain present 2 days post 2nd IM injection and right arm injection site is warm to touch with redness and firmness to touch.
49 2021-01-11 weakness doesn't feel good; her body is hurting/her left side hurts/her body hurts/it's like somebody hit her... Read more
doesn't feel good; her body is hurting/her left side hurts/her body hurts/it's like somebody hit her hard; headache; so weak; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date: unknown), via an unspecified route of administration on 06Jan2021 at 12:30 at a single dose for Covid-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine the day before (06Jan2021) and doesn't feel good in the morning, her body is hurting, and she has a headache. The patient is a CNA and she got the vaccine the day before at around 12:30 and she just got up in the morning, so weak, and her left side hurts. Her body hurts and she doesn't feel good too, reportedly "all the body hurts now, it's like somebody hit her hard". The patient asked if she can take Tylenol or pain medication. After receiving a verbal response, the patient added that she would take Tylenol and pain medication together and hopefully get some sleep. The patient then asked if headache and body ache are normal side effects of the vaccine. The outcome of the events was unknown. Information about batch/lot number has been requested.
49 2021-01-11 feeling hot, burning sensation, hot flush 99 yo obese DMII smoker reported during post-vaccination monitoring for Pfizer COVID 19 that she wa... Read more
99 yo obese DMII smoker reported during post-vaccination monitoring for Pfizer COVID 19 that she was experiencing a burning sensation without pain in her neck, hips and along the spine area of her lower back. She reported feeling warm but stated it was likely a hot flash. She reported that when she has a flu shot she has localized arm burning sensation similar to this burning. Denies difficulty breathing, or swelling of any portion of her body. Patients states she is comfortable self-monitoring and plans to go to work. Patient released to self after monitoring for 1 hour. If patient later seeks medical care, we requested she inform us of the outcome.
49 2021-01-11 pain in extremity Pain in left arm began within 30 min. of injection and has lasted over 24 hours with radiation down ... Read more
Pain in left arm began within 30 min. of injection and has lasted over 24 hours with radiation down into elbow, wrist, hand and fingers.
49 2021-01-11 pain in extremity Sore arm, headaches; Sore arm, headaches; This is a spontaneous report from a non-contactable other ... Read more
Sore arm, headaches; Sore arm, headaches; This is a spontaneous report from a non-contactable other HCP (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Vaccine location was right arm. Patient is not pregnant. Patient received the first dose on 17Dec2020 05:45 PM also at right arm for covid-19 immunization. Lot number was also EJ1685. The facility type vaccine was hospital. Medical history included Celiac. Concomitant medication included pregabalin (LYRICA), celecoxib (CELEBREX), escitalopram oxalate (LEXAPRO), spironolactone. Known allergies: Penicillin, morphine, lactated ringers. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient experienced Sore arm, headaches at 05Jan2021 06:00 PM with outcome of recovered in Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious. No follow up attempts are possible. No further information is expected.
49 2021-01-11 tenderness Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sou... Read more
Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sour; Tender; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 49-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9232) Intramuscular at Left arm on 04Jan2021 08:00 AM at single dose for COVID-19 immunization. Medical history included known allergies to sulfa based antibiotics and a steroid. There are other medications in two weeks. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took ibuprofen and had allergy. Patient experienced arm, shoulder, and neck swollen. Extremely sour and tender on 04Jan2021 11:00 AM. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at workplace clinic. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect. Patient was recovering from the events.
49 2021-01-11 tremor The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness... Read more
The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness, sweating, and shakiness. The ambulance was called just to be on the safe side. She was taken to the hospital via ambulance and was later discharged that same night as symptoms improved.
49 2021-01-12 flushing Reported feeling flushed and experienced chest pressure. Transferred to ED
49 2021-01-12 hot flush My adverse reaction was a hot flash for about 10min on 12/31/2020 and on 01/01/2021, I found a small... Read more
My adverse reaction was a hot flash for about 10min on 12/31/2020 and on 01/01/2021, I found a small pea size lump on my right collar bone area that has now increased in size to a quarter size lump that's mildly tender.
49 2021-01-12 numbness, tingling Covid-19 given at 0845, @ 0855 client complained of left arm numbness and tingling on fingers. Provi... Read more
Covid-19 given at 0845, @ 0855 client complained of left arm numbness and tingling on fingers. Provider onsite: NP evaluated the client, advised to wait for another 15 minutes. @0932 per client she is feeling better. Provider onsite advised client to see her PMD if the reaction will get worse. Client left the clinic in Ambulatory stable condition.
49 2021-01-13 weakness Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling ... Read more
Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling good; awful stomach ache; could not eat/she can't eat; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. Medical history included ongoing overweight. Concomitant medications were not reported. The patient experienced sick to her stomach/super sick stomach on 03Jan2021 with outcome of unknown, not feeling good on 03Jan2021 with outcome of unknown, awful stomach ache on 03Jan2021 with outcome of unknown, could not eat/she can't eat on 03Jan2021 with outcome of unknown, body ache on 07Jan2021 with outcome of unknown, fatigue on 07Jan2021 with outcome of unknown, weakness on 07Jan2021 with outcome of unknown, abdominal noises on 07Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: unknown on 05Jan2021. Therapeutic measures were taken as a result of sick to her stomach/super sick stomach (nausea) and included treatment with Pepto-Bismol.
49 2021-01-13 flushing 15 minutes after im shot, patient experienced itchy feeling and then flushed face patient was admin... Read more
15 minutes after im shot, patient experienced itchy feeling and then flushed face patient was administered diphenhydramine 25mg orally and observed . No additional side effects occurred
49 2021-01-13 flushing SM presents today for second dose of Pfizer vaccine at 0724 13 mins post injection SM states she beg... Read more
SM presents today for second dose of Pfizer vaccine at 0724 13 mins post injection SM states she began feeling her throat was scratchy, mouth tasted metallic and a flushed felling over her entire body. SM attached to VS machine. Initial set of vitals were HR 77 bpm, spo2 100% on RA, and left arm blood pressure 158/84.
49 2021-01-13 numbness -Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on... Read more
-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on the right side - Jaw, neck & right -Lyphnote under the right arm is swollen. -Neck & under armpit pain because of this -The night after getting the 2nd vaccine Covid I started getting chills, fever of 102+ Extreme body ackes -Right arm armpit lymph nodes swollen the size of my fist -Right side of my neck also swollen -The Right lower back hurts as well -From 1 to 10 is an 8 acute pain
49 2021-01-13 numbness c/o numbness at site of injection. Numbness from left deltoid distally to left hand. No other sympto... Read more
c/o numbness at site of injection. Numbness from left deltoid distally to left hand. No other symptoms noted. Monitored for 30 minutes.
49 2021-01-13 numbness Right arm numbness occurred within the 15 minute waiting period. It did not start immediately with t... Read more
Right arm numbness occurred within the 15 minute waiting period. It did not start immediately with the injection but rather 5 minutes after. Lasted about 3 minutes before completely resolving. The right arm numbness returned on 01/01/2021 and persisted through 01/03/2021. Went away and returned on 01/06/2021 then migrated to the left arm. Waxes and wanes and added numbness to bilateral lower legs and feet. Improved with less frequency by 01/14/2021.
49 2021-01-13 pain in extremity felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of ery... Read more
felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of erythema; 'knot' noted on left deltoid Itchy, but painful; pulse 77 to 94 from lying to standing; 'knot' noted on left deltoid Itchy, but painful/left lateral deltoid with 3.75 x 5 cm mildly tender; indurated area of erythema, with central erythematous punctum (presumed site of injection); indurated area of erythema, with central erythematous punctum (presumed site of injection); This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, 30mcg/0.3ml), intramuscular on 31Dec2020 15:38 (also reported as 08:30 am) at 0.3 mL, single at left deltoid for covid-19 immunization. Medical history included significant for Covid 19 infection (positive test 28Oct2020), shortness of breath, dizzy, hospitalized for decreased O2 saturation from 04Nov2020. Patient was treated with remdesivir for Covid 19 infection. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, it was unknown if patient had been tested for COVID-19. Patient felt dizzy after receiving injection on 01Jan2021, left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 01Jan2021; knot grew to 5x5 cm max size over 48 hours, itchy, but painful if tried to scratch. Some dizziness with position change. Examination: no fever, no orthostatism to BP, pulse 77 to 94 from lying to standing, left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Patient took diphenhydramine hydrochloride (BENADRYL) 03Jan2021, and cetirizine hydrochloride (ZYRTEC) 04Jan2021 for events (Instructed to take OTC antihistamine (cetirizine hydrochloride) daily until 7 days after symptoms resolve). Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment diphenhydramine, certitizine for events. The report is considered as non-serious. Outcome of events was unknown.
49 2021-01-13 pain in extremity Patient describes nausea, fatigue and headache. Also has arm soreness, but very mild
49 2021-01-13 pain in extremity Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site p... Read more
Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site pain
49 2021-01-14 weakness FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAI... Read more
FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAIN JOINTS,FEVER,NAUSEATE,FEELING BAD.
49 2021-01-14 bell's palsy Bell's Palsy left side
49 2021-01-14 feeling cold, burning sensation, feeling hot Burning and itching at site, increased blood pressure, redness and burning down both arms, redness i... Read more
Burning and itching at site, increased blood pressure, redness and burning down both arms, redness in face, hot, sweaty, and cold
49 2021-01-14 pain in extremity, feeling hot the skin overlying the injection site has an intense prickly "itchy" sensation; left side of my face... Read more
the skin overlying the injection site has an intense prickly "itchy" sensation; left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face; left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face; I had a short episode of disequilibrium; awoken by intense bilateral leg pain; my legs felt weak the following day; This is a spontaneous report from a contactable Physician who reported for herself. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231) for COVID-19 immunisation on 07Jan2021 at 15:30 at single dose in Left arm. Medical history included allergy to penicillin , clindamycin, azathioprine (IMURAN) (known allergies: penicillin, clindamycin, Imuran) , allergy to glove powder and autoimmune disorder (unspecified). Concomitant medication (received within 2 weeks of vaccination) included hydroxychloroquine sulfate (PLAQUENIL), methotrexate, mycophenolate mofetil (CELLCEPT), folic acid and magnesium. On 07Jan2021 at 17:30 , approximately 2 hours after she received the vaccine, she had a short episode of disequilibrium, then an hour after that (at 18.30) the left side of her face felt heavy, stiff and was palpably warmer than the right side of her face. There were no visible changes to the appearance of her face, and she had normal motor control. This episode lasted for approximately 1-2 hours then gradually diminished. In Jan202, approximately 36 hours after the vaccine, patient was awoken by intense bilateral leg pain. The pain gradually diminished after approximately an hour, but her legs felt weak the following day. Legs were fine on 10Jan2021. In the evening of 09Jan2021 though 10Jan2021, the skin overlying the injection site had an intense prickly "itchy" sensation, there was no rash. Events were all non serious. No treatment administered and final outcome for all the events was reported as recovering.
49 2021-01-14 pain in extremity left arm pain, generalized body aches, chills and fatigue. Treatment included Tylenol the next day.... Read more
left arm pain, generalized body aches, chills and fatigue. Treatment included Tylenol the next day. Outcome: Moderate improvement has continued c/o of mild fatigue and generalized body aches that does interfere with ADL's currently working.
49 2021-01-14 pain in extremity She stated: I received my 2nd dose of vaccine on 1/11 24hours after I experienced severe arm sorenes... Read more
She stated: I received my 2nd dose of vaccine on 1/11 24hours after I experienced severe arm soreness which progress to body aches and tongue swelling. I took 50mg of Benadryl and 40 mg of prednisone that I had at home and my symptoms resolve gradually and I felt better the next day
49 2021-01-14 pain in extremity immunization (site on the right upper arm) on 1/10/21 with increased right arm pain at rest and move... Read more
immunization (site on the right upper arm) on 1/10/21 with increased right arm pain at rest and movement, then flu like symptoms 1/11-14/21: aches, fatigue, malaise, head ache; on 1/12/21 in the afternoon I noticed right axilla pain in axilla, same level at the upper back/ribcage under the shoulder blade and corresponding pectoralis muscles and swell in axilla and upper pectoralis muscles, I could also palpitate multiple firm and tender lymph nodes at the right axilla.
49 2021-01-14 tingling After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated s... Read more
After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated she has 2 bowel movements, denies diarrhea. She felt very tired. Both her hands felt tingly. BP 117/75 - 85bpm - 98% RA. She was not pale or diaphoretic. No medication given. She slept for ~90 minutes in the vaccination room on the gurney. She felt well upon awaking. Drank water and ate crackers. She left in stable condition.
49 2021-01-15 pain in extremity dizzy, nausea, headache, myalgia, fatigue, arthralgia, then on 1/14 fever 10.3 headache continued a... Read more
dizzy, nausea, headache, myalgia, fatigue, arthralgia, then on 1/14 fever 10.3 headache continued arm sore, did call out of work 1/14 took Tylenol and motrin
49 2021-01-15 pain in extremity Day 10 post injection I experienced: Severe Headache Palpitations Increased Heart Rate SOB Cough Diz... Read more
Day 10 post injection I experienced: Severe Headache Palpitations Increased Heart Rate SOB Cough Dizziness Lightheadedness Fatigue Chills Sneezing Sore arm (first 3-4 days). I had a negative COVID test on 1/12/21.
49 2021-01-16 hot flush, pain in extremity Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. ... Read more
Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. Had a feeling of being in a fog and not quite myself. Taste and smell felt distorted and could not fully taste and smell my coffee. Took 2 max strength tylenol which helped bring temp down to 98.F and remained steady till the afternoon when temp went up to 102F. Had feeling of body aches and chills. Took a hot shower and another dose of tylenol and went to bed. Next morning felt much better with no fever symptoms. Left arm was sore but better than day before. Woke up with a vertigo feeling and hot flashes but not enough to interrupt daily activities. Treated with meclizine
49 2021-01-16 pain in extremity Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Fe... Read more
Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Felt Strange just not well. Ran a fever through the night into the next morning., Friday 1/15/21 had a fever of 100.5 taken by ear. Fever subsided. Began having a slight headache that lasted through Sunday. Also had Nausea that started Friday and continued through today. Sunday. Injection arm has been very sore. I also have a very sore enlarged lymph node under my left arm pit. Markedly swollen.
49 2021-01-17 difficulty speaking Patient received Pfizer 1st dose and asked the patient to wait for 30 minutes post vaccination to ob... Read more
Patient received Pfizer 1st dose and asked the patient to wait for 30 minutes post vaccination to observe for any sort of adverse reactions. 30 minutes later patient complained of having sore throat and her voice sounded hoarse. Patient asked to wait to see if symptoms improved. 15 minutes later patient complained of short of breath and throat tightness. Given albuterol nebulizer and benadryl. Patient further monitored and vital signs were stable. 5 minutes later patient remained short of breath and rapid response was called and patient was taken to ER. Given Benadryl 25 mg IV and famotidine 20 mg IV. In ER, given 125mg methylprednisolone and 0.3mg of epinephrine. Patient discharged from ER.
49 2021-01-17 feeling cold headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp... Read more
headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp 98.9, nausea, blurry vision, pass out once 2-3 mins, feverish at night 99.9
49 2021-01-17 hot flush palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on ... Read more
palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on my arms and abdomen; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), intramuscular in the left arm on 06Jan2021 16:00 (at the age of 49 years old) at a single dose for COVID-19 immunization. Medical history included psoriasis, microscopic colitis, allergies to shellfish, and coconut. The patient's concomitant medications were not reported. The patient previously took estrogen patch, etanercept (ENBREL) and sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies to all. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medications with 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 16:15, the patient experienced a very warm flush feeling, nausea started and by 15 minutes, she had swelling of the throat and rash on her arms and abdomen and the palms of her hands were bright red. The events resulted in Emergency room/department or urgent care visit. The patient was treated with diphenhydramine hcl (BENADRYL), steroids (unspecified), famotidine (PEPCID) and ondansetron (ZOFRAN) in response to the events. The patient assessed the events as non-serious. The outcome of the events was recovered with sequel on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-01-17 numbness, tingling *eyelid area on both sides of face felt tingly/numb for about 20 minutes which started about 40 minu... Read more
*eyelid area on both sides of face felt tingly/numb for about 20 minutes which started about 40 minutes after the shot was administered. *42 hours after administration of vaccine, I woke up with a metalic taste in my mouth which has laste for 6 hours
49 2021-01-17 pain in extremity, tingling 1. Tingling in left ring finger immediately 2. Left arm burning and soreness starting at injection ... Read more
1. Tingling in left ring finger immediately 2. Left arm burning and soreness starting at injection site and traveling down arm worse within 48 hours with continued pain left arm with on and off altered sensation left ring finger currently (3 weeks post injection) 3. Early fatigue left arm 4. Significant body/bone aches for 6 days
49 2021-01-17 pain in extremity I woke up with hills, body aches 12 hrs after 2nd dose. My arm was hurting I expected that was one o... Read more
I woke up with hills, body aches 12 hrs after 2nd dose. My arm was hurting I expected that was one of the symptom as 1st dose. The following day chills, body ache fever 99.6 took Ibuprofen slept most of the day. On 1/17 started exp stomach cramps (described as the muscles in stomach).
49 2021-01-17 tingling 49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. ... Read more
49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. Patient states that she got her first Covid vaccine yesterday afternoon and states that she has noted some swelling in her hands and also feels as though she has burning pain and pins-and-needles in her hands. She denies any weakness in her distal extremity. She states the sensation extends from her fingertips to her mid forearm. She also states that she has noted some lymph node pain in her groin and neck. She denies any fevers or chills. She denies any throat tightness, shortness of breath, wheezing, abdominal pain, nausea, vomiting or rash associated with her symptoms. Patient is alert and oriented ×3, cranial nerves II through XII intact bilaterally, no pronator drift, paresthesias in glove like distribution from hand to mid forearm bilaterally. Sensation intact in bilateral lower extremities, 5/5 strength in upper and lower extremities, cerebellar function intact with finger to nose bilaterally. No visual field deficits by confrontation. Discussed laboratory findings with patient. She did also does have a mildly elevated creatinine outside of kidney injury however suspect may be source for mildly elevated phosphorus. Given 1 L of fluids. Recommended close follow-up with PCP for laboratory recheck and further evaluation. No signs of acute anaphylaxis or angioedema. Discussed return precautions with patient if she were to have worsening symptoms
49 2021-01-17 tenderness swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout t... Read more
swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout the weekend
49 2021-01-18 weakness Woke up shivering at 1 A.M. Saturday so bad that my husband thought I was having a seizure, took my... Read more
Woke up shivering at 1 A.M. Saturday so bad that my husband thought I was having a seizure, took my temp it was 104. Took Tylenol, held cool compress on my forhead, the next day had bad chills, throbbing headache, and temp never dropped below 100. I was very weak, every muscle in my body ached, couldn't eat, yet my blood sugar was high all day. Kept checking my temp. It was avg. 102 . Read about the side effects, seemed like I just had it worse than others. Then into Monday morning, still felt awful, but had woke up in a pool of sweat, temp finally fell to 99 . Seemed like the worst was past, was able to eat a little breakfast, but then the diahrea started! I called in sick again, and went to Urgent care. The Dr. said I had a severe adverse reaction to the second vaccine. I asked for a Covid test just in case. Now Tuesday, felt better today, still a bit tired, temp has been avg. of 98 today, got results from test, negative.
49 2021-01-18 cold sweat, tremor, weakness Following my 2 dose of the Phizer Covid Vaccine I experienced a temperature of 101.0 spiking over th... Read more
Following my 2 dose of the Phizer Covid Vaccine I experienced a temperature of 101.0 spiking over the course of 2 days, sever body shaking, dizziness, weakness, and cold sweats. These symptoms lasted for approx. 2 1/2 days. 3-4 days following my severe symptoms I was extremely sore in my neck muscles and fatigued. My balance felt "off".
49 2021-01-18 flushing Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a ... Read more
Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (Arm Right) first dose on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history included known allergies: Bee Venom, Coconut, and Shellfish. The patient's concomitant medication included vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), metoprolol, zolpidem tartrate (AMBIEN), and dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]). The patient previously took Fenofibrate and experienced allergies. On 08Jan2021, the patient experienced Itching hives on the trunk and bilateral arms with 15 minutes, Facial Flush, Tachycardia, Elevated. The patient was treated with Benadryl. The patient went Emergency room/department or urgent care due to the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination and was not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
49 2021-01-18 flushing 10 mins after first dose - Flushed, heart racing and head pressure. BP 139/89 - HR 115 Took Benedryl... Read more
10 mins after first dose - Flushed, heart racing and head pressure. BP 139/89 - HR 115 Took Benedryl 25 mg P.O. Denied ER visit Released home.
49 2021-01-18 flushing Rash, Anxiety, Flushed
49 2021-01-18 numbness Pfizer C19 vaccine given, Patient was a staff member at facility, felt unwell, blood pressure was ta... Read more
Pfizer C19 vaccine given, Patient was a staff member at facility, felt unwell, blood pressure was taken by observer, pt ultimately felt well enough to go back to her office. At some point she contacted her doctor by phone and came back to observation reporting numb tingly lips and cheeks (covered by mask). Requested a diphenhydramine 50mg, which was given at 1400. rated reaction feel as level 5. After 25 minutes asked again and rated level 1. Contacted doctor. He cleared her to go home and would follow up in 2 hours to see how she was doing.
49 2021-01-18 pain in extremity, weakness, migraine Took Wednesday, by Friday under left arm was swollen, chills, body aches, migraine, low energy, tire... Read more
Took Wednesday, by Friday under left arm was swollen, chills, body aches, migraine, low energy, tiredness, couldn't get up, Sunday felt same way and called in to work, Monday weakness in both legs, went to work, today under arm is still sore. When i rub on deodorant underarm is very sore, left arm feels funny. Today still have migraine, i started Tylenol on Thursday, by Friday evening i was taking tylenol every 6 hours until yesterday. I used medicated over the counter pouch, put hot cloth under arm for swelling and it did go down some, but is still not back to normal. Everything i was feeling was on my left side, by Saturday whole body was aches, continued taking tylenol but now just left arm is sore. Migraine comes and goes. My doctor told me this morning she experienced everything i told her.
49 2021-01-18 pain in extremity Could not raise it above shoulder, when turning steering wheel pain with up and over motion, could n... Read more
Could not raise it above shoulder, when turning steering wheel pain with up and over motion, could not lift anything; patient's left arm was very sore, achy; Bruise on injection site; This is a spontaneous report from a contactable other hcp. A 49-years-old female patient started to receive bnt162b2 (BNT162B2) , via an unspecified route of administration, lot number: EH9899, from 23Dec2020 11:00 at a SINGLE DOSE for COVID-19 immunization. Medical history included obesity, hyperthyroid and vit d deficiency. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included topiramate (TOPAMAX), bupropion, darifenacin (ENABLEX) and levothyroxine. On 23Dec2020 15:00, the patient's left arm was very sore, achy, could not raise it above shoulder, when turning steering wheel pain with up and over motion, could not lift anything. Pain was described as worse than flu shot which lasted 24 hours. She also had bruise on injection site that lasted two weeks. Outcome of events was recovered. No treatment was received/required due to events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
49 2021-01-18 pain in extremity Dose #1, Day 2-Approx 24hrs after IM injection started with finger joint swelling/pain/limited ROM a... Read more
Dose #1, Day 2-Approx 24hrs after IM injection started with finger joint swelling/pain/limited ROM and difficulty grasping items by end of day. Day #3 Fingers improving. Day 4 Knees swollen and difficulty bending or climbing stairs, resolved by Day 5. Dose #2, Day 1- 12 hrs after injection started with joint stiffness in hands. Day #2 Finger joint swelling/pain. Day #3 finger,hand,shoulder,hip,knee and metatarsal pain/swelling/limited ROM. Day #4 (same as Day 3), DAY 5,6,7 symptoms improving: able to complete 12 hr shift at work. Day 8 finger/hand joint swelling/pain/stiffness
49 2021-01-18 pain in extremity Later in day intense headache and now two days later still intense headache, muscle aches/soreness(m... Read more
Later in day intense headache and now two days later still intense headache, muscle aches/soreness(mostly arms neck back), very tired, chills, low grade temp. flu like). Even had to miss work.
49 2021-01-19 weakness, muscle spasms I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level ... Read more
I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level was 8 out of 10. When I tried to get out of bed, I was dizzy and had to hold to the walls to make it to the bathroom. I had severe dry mouth, nausea, muscle weakness, loss of appetite and chills. I was unable to go to work. The symptoms did not begin to subside until later in the evening the next day around 6:30pm. Today I am still weak but making it. Still having chills, and some minor muscle aches and spasms.
49 2021-01-19 numbness, tingling generalized numbness and tingling down both arms extending from shoulders to fingers, transient sens... Read more
generalized numbness and tingling down both arms extending from shoulders to fingers, transient sensation of bandlike chest tightening across rib cage, BP 156/94 with pulse oximetry 98, pulse 111. Observed one hour without allergic signs or symptoms and no wheezing.
49 2021-01-19 numbness Within 20 minutes lips, face, left arm felt numb. Not long after that I had an asthma attack, hard t... Read more
Within 20 minutes lips, face, left arm felt numb. Not long after that I had an asthma attack, hard time catching my breath, throat became itchy. This lasted for around 35 minutes.
49 2021-01-19 pain in extremity, weakness I awoke with severs chills, fever at 5 am. I have muscle/joint pain, very fatigued, slight headache... Read more
I awoke with severs chills, fever at 5 am. I have muscle/joint pain, very fatigued, slight headache, fever of 101.2, arm soreness on first day. Today (2nd day) temp of 100, body fatigue/weakness, slight headache, arm soreness, but overall feeling better.
49 2021-01-19 pain in extremity : TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and ... Read more
: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and fatigue following the vaccination. Those symptoms lasted a few days and resolved. On 1/17 she noticed a sore area under her left arm. she has a small firm painful lymph node under the left arm. She also noticed that she has a slight " fullness" in the neck area. She feels like her thyroid gland is more pronounced. than it was prior to the vaccine. She denies any dysphagia or odynophagia. No SOB or tachypnea. No fever or chills. No hx of thyroid dysfunction.
49 2021-01-19 pain in extremity "I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I starte... Read more
"I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I started with severe pain in my left leg. The pain worsened through the day and my leg began swelling. No other symptoms at all. This morning my leg was twice the size of my right leg so I went to the ER. I live in so I'm at ED. I have a massive blood clot running the the length of my leg - from my thigh to my ankle. I'm very lucky I got here so fast! I?m a very healthy 49 year old with no history of DVT or blood clots so they dug further to find out why. A cat scan showed I have a congenital condition called May Thurner Syndrome. I?m so relieved to have an answer and it?s fixable! The vascular doctors are not 100% convinced that?s not all that was going on as I was born with the syndrome and I?ve gone this long without a clot. So they are doing lots of labs to see if anything else shows up. This is where we are at. I?m being admitted to take care of the clot."
49 2021-01-19 pain in extremity Patient reports acute pain at the injection site immediately after vaccination that lasted for an ho... Read more
Patient reports acute pain at the injection site immediately after vaccination that lasted for an hour and a half, she also had pain up and down her arm and into her neck. She reports numbing/tingling in both cheeks for half an hour after receiving the vaccine. 9 days later she continues to experience pain up and down the injected arm from wrist to shoulder and into her neck. The pain is somewhat relieved by NSAIDs.
49 2021-01-19 pain in extremity Sore arm, moderate body aches, fatigue, mild headache 14 hrs post 2nd vaccine First vaccine zero sid... Read more
Sore arm, moderate body aches, fatigue, mild headache 14 hrs post 2nd vaccine First vaccine zero side effects except arm soreness
49 2021-01-19 tingling Pt entered observation @ 1645. @ 1704 states prickles felt on back and arm. States s/s had been go... Read more
Pt entered observation @ 1645. @ 1704 states prickles felt on back and arm. States s/s had been going on about 10 mins before she said anything. Benadryl 25mg given @ 1705. Does have allergies to Flu Vaccine, MRI Dye, Vicodin, Buspar, Lisinopril, Suchycin. Celexa, Prev Pack, Lexapro, Penicillin, Hydrocodone, and Fluoxetine. Remains to voice s/s @ 1729. Red Blotchy areas noted to face and neck. Pt states this is normal for her when her anixety level is high. V/S were taken @ 1733 BP-193/105, P-74, R-18, 02-100% on L arm. V/S obtained on R arm @ 1731 BP-193/111, P-76, R-18, O2-100%. States that takes BP meds daily @ night, in which she hasn't taken her meds all day. Takes Amlodipine 5mg, Klonopin 0.5mg, Vit D 1000, MVI, Clartin 5mg, and Zantac 150mg. Stil continues to voice s/s @ 1739. BP remains elevated. Patient sent to ER @ 1740. Pt entered registration @ ER @ 1745. Pt continue to voice s/s of prickling noted to body. Denies SOB nor trouble w/ breathing.
49 2021-01-19 speech disorder, numbness, tingling, discomfort 29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my... Read more
29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my lips. i informed nurse and she began taking blood pressure and oxygen levels while asking if i was breathing ok. i said yes. i then felt the right side of my lips go numb. i felt a faint tightness in my throat but after about two minutes it felt like my right side of the lips started to feel normal and my throat. then all at once i felt the blood rush from my body and tingling all over. i told the nurse i didnt feel good. she layed me down on the floor and put my feet up. she asked what i was feeling and i said i felt like i was going to faint. i was aware that my tongue felt heavy and i wasn't talking clear. another nurse got the allergist or doctor on standby and she asked me what i was feeling. i just rubbed my throat and my cheeks and lips and felt numbness and my throat tight and my tongue very thick. she asked if i was having a hard time swallowing. i nodded so she said they were going to sit me up because they needed to give me an Epipen. i nodded, tgey brought a wheekchair for me and as they helped me stand because i had no strength, a nurse stabbed me with the Epipen then they took me to the emergency room and observed me until 2:30pmish to make sure i didnt have another episode. then i wss discharged and was told to follow up with my primary care doctor within 3 days. An allergist will also see me to do a skin test.
49 2021-01-20 weakness, tremor Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vo... Read more
Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vomited at 5am on jan 18; Jan18 fever and chills continued, no apetite all day; dizzy; weak; severe body aches; confined to bed all day; severe head ache; very sensitive to light; could not sleep for more than 15-45 minutes at a time; food tasted like chemicals or sickeningly sweet; only rice tasted normal; very sensitive to and repelled by odors. Jan 19: nausea abated, started to eat a few things but eveything still tasted terrible except for rice; got tested: covid negative, flu A &B negative, RSV negative; body aches were much worse; difficult to walk due to shooting pain in feet and back; stayed in bed all day; Jan 20 fever broke, now have right side sore throat; still achy and dizzy; Jan 21 still have headache and mild body aches, not confined to bed but too weak and achy to work
49 2021-01-20 feeling cold, tingling All of my symptoms occurred later in the evening: Very cold (lasted 1 night) nausea (lasted 2 days) ... Read more
All of my symptoms occurred later in the evening: Very cold (lasted 1 night) nausea (lasted 2 days) light headed (lasted 1 night) tingling sensation in hands, feet, legs, and arms (this is still happening as of today)
49 2021-01-20 feeling hot, hot flush, flushing Hives; legs were feeling itchy; red blotches to back of thighs/red blotches to both inner arms/red b... Read more
Hives; legs were feeling itchy; red blotches to back of thighs/red blotches to both inner arms/red blotches mostly to both calves; redness to right leg/redness to right thigh/she had redness, flushed and warmth of face; stated that all the flushed areas were hot to touch; redness to face (flushed)/she had redness, flushed and warmth of face; she had redness, flushed and warmth of face; moderate allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) via an unspecified route of administration in the right arm, on 07Jan2021 at a single dose, for COVID-19 immunization. Relevant medical history included right eye surgery on 06Jan2021, severe allergies, environmental and drug allergies. The patient has no concomitant medications. The patient stated that she had first dose of COVID vaccine on Thursday. Stated that she has sent V-safe reporting updates. Stated that she had a moderate allergic reaction to the vaccine on an unspecified date in Jan2021. She had noticed hives when she woke up on Friday morning (08Jan2021) that her legs were feeling itchy. She stated that she has hives, red blotches on back of thighs, arms and mostly on calves. The area was hot to touch. She then clarified that all the flushed areas were hot to touch. She was feeling a little better. She stated that they looked like they were trying to dry up and she has new ones. She had redness, flushed and warmth of face that started the day of vaccine that night (07Jan2021). She had red blotches to back of thighs Friday evening and they were starting to fade. Stated that the blotches to her left leg started Friday and that evening redness started to right leg and thighs. The blotches to both calves are still warm but starting to improve. The redness to her right thigh is more pink than red now. The patient was Benadryl around the clock and using Aveeno cream as treatment for the events. She has always had severe allergies but has not had an allergic reaction in over year. She also has history of environmental and drug allergies. Patient was trying to determine if should go back for second vaccine due to the reaction. She had asked for a consult from the immunization doctor before receiving the vaccine because she has history of severe allergies. Outcome of the events hives, and redness was not recovered, for events flushing, hot flushes, and red blotches was recovering, while for the remaining events was unknown.
49 2021-01-20 migraine Fever, body aches, chills, migraine excessive tiredness
49 2021-01-20 migraine Migraine Swollen axilla lymph nodes Low grade fever 100 Chills
49 2021-01-20 muscle spasms, numbness, tingling Severe leg muscle cramps all the way to feet. Numbness and tingling. Lasting well over an hour at th... Read more
Severe leg muscle cramps all the way to feet. Numbness and tingling. Lasting well over an hour at this time
49 2021-01-20 muscle spasms, pain in extremity, limb paralysis Severe leg cramps. Temporary paralysis of both legs. Intense pain in both legs and feet. Several epi... Read more
Severe leg cramps. Temporary paralysis of both legs. Intense pain in both legs and feet. Several episodes lasting approximately 10 minutes
49 2021-01-20 pain in extremity, tenderness Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot bu... Read more
Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot but not as severe.; Left below knee pain and discomfort. Some to the right leg as well.; Left below knee pain and discomfort. Some to the right leg as well.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort; This is a spontaneous report from a contactable nurse reporting for herself. A 49-years-old female patient started to receive bnt162b2 (BNT162B2; Lot: ECO142) vaccine , intramuscular in the left arm on 29Dec2020 15:45 at single dose for Covid-19 immunisation . Medical history included hypertension, anaemia, blood cholesterol increased , depression, food allergy (whey casium) (taking doxepin for it with relief). Concomitant medication included doxepin (DOXEPIN), metoprolol (METOPROLOL), calcium ascorbate (VITAMIN C [CALCIUM ASCORBATE]), tocopherol (VITAMIN E [TOCOPHEROL]), cyanocobalamin (VITAMIN B-12) , atorvastatin (ATORVASTATIN), sertraline (SERTRALINE). The patient experienced felt like a restless leg or blood clot but not as severe. on 30Dec2020 07:00 with outcome of recovered , left below knee pain and discomfort. some to the right leg as well. on 30Dec2020 07:00 with outcome of recovered , checked back of leg for warmth or bruising lasted day 2 and day 3. on 30Dec2020 07:00 with outcome of recovered , did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort on 30Dec2020 07:00 with outcome of recovered. The event blood clot was considered serious (Important Medical Event). Course of the events The patient reported left below knee pain and discomfort. Some to the right leg as well. She checked back of leg for warmth or bruising lasted day 2 and day 3. She felt like a restless leg or blood clot but not as severe. She felt better to stand instead of sitting. Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort. No shortness of breath, no nausea, no dizziness, no increased fatigue (baseline - not enough sleep - working 3 jobs).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported leg thrombosis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-01-20 pain in extremity Swelling very red painful growing spot at injection site, beginning a few hours after injection, sor... Read more
Swelling very red painful growing spot at injection site, beginning a few hours after injection, soreness in entire arm beginning the morning after the injection more severe than with the flu vaccine, nausea two days past vaccination
49 2021-01-20 pain in extremity A lot of pain in arm; arm was completely swollen with hard ball underneath where the injection was g... Read more
A lot of pain in arm; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; This is a spontaneous report from a contactable other hcp (patient). A 49-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose bnt162b2 on 18Dec2020 for Covid-19 Immunization and experienced a lot of pain in arm which was normal. On 10Jan2021, the patient's arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy and on an unspecified date the patient had a lot of pain in arm. She had not taken anything other than acetaminophen (TYLENOL) 650 mg. The patient thought it was due to the vaccine (COVID-19 vaccine) she got the reaction. The outcome of the events was unknown.
49 2021-01-20 pain in extremity Sore arm day of. Next day: Headache, extreme fatigue, nausea, low grade fever of 99 these symptoms l... Read more
Sore arm day of. Next day: Headache, extreme fatigue, nausea, low grade fever of 99 these symptoms lasted until 1/15/21 at 1300.
49 2021-01-20 pain in extremity Sore and heavy arm after an hour. The next day i felt body ache.
49 2021-01-20 tingling, pain in extremity fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches... Read more
fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches; headaches; This is a spontaneous report from a contactable physician (reporting for herself). A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included hashimoto thyroiditis and hypertension. Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide (HCTZ), biotin, cyanocobalamin, folic acid (MVI 3), influenza vaccine inact split 3v (FLULAVAL) taken for immunization on 03Dec2020. On 23Dec2020 12:15, the patient experienced fast heart rate, tingling in feet, mild tightness in the chest, shaking chills, sore arm, body aches and headaches. The patient underwent lab tests and procedures which included heart rate: fast on 23Dec2020. There was no treatment given for any of the events. The outcome of the events was recovered in Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
49 2021-01-21 weakness Fever-around 101.7 had lasted for 36 hours. Chills and extreme muscle pain Weakness
49 2021-01-21 flushing Patient called for encounter: She received Pfizer COVID-19 Vaccine 07JAN2021. 08JAN2021 developed fl... Read more
Patient called for encounter: She received Pfizer COVID-19 Vaccine 07JAN2021. 08JAN2021 developed flushing on face, lower extremities and hives on left leg. Hives progressed to both legs and arms. She then developed swelling on the left side of the roof of her mouth. She started taking benadryl every 4-5 hours for 7 days. She did not use the EpiPen. Simultaneously patient developed vasculitis flare - pain involving ankles and lower legs. No hx of allergy to polyethylene glycol. Prior to vaccine - no changes in exposure other than eye surgery the day before vaccine which utilized the same medications that have been used for prior eye surgeries
49 2021-01-21 numbness, throat numbness At 0847 patient reported numbness to face, lips, and throat. No SOB nor difficulty breathing. Denied... Read more
At 0847 patient reported numbness to face, lips, and throat. No SOB nor difficulty breathing. Denied pain. No antidote nor supportive treatment given. After ~40 minutes of observation, minimal numbness and no SOB. Patient left clinic.
49 2021-01-21 pain in extremity Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over bod... Read more
Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over body aches, severe right ankle/heel pain, headache, fever 101, chills, sweats. 1/22/2021 left axillary lymph node swelling and soreness.
49 2021-01-21 pain in extremity My left arm was sore and second day I felt very fatigued. I had really bad headaches. My muscle pa... Read more
My left arm was sore and second day I felt very fatigued. I had really bad headaches. My muscle pain was mild but my headaches have not gone away they are usually mild to moderate.
49 2021-01-21 unresponsive to stimuli Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We ... Read more
Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We sat her down and then she said her chest felt tight and said she felt as if her heart was racing. Went unresponsive, still breathing, for almost 1 min. Came to and then began to dry heave. Her breathing became wheezy and rapid and her bottom lip began to turn blue. We administered an EpiPen about 5:03pm and the rescue squad took her to the hospital. They administered Benadryl and Ativan in the ER and sent patient home that evening.
49 2021-01-23 tremor fever of 103 degrees with chills, uncontrollable shaking, vomiting beginning around 8:00 PM, Tyleno... Read more
fever of 103 degrees with chills, uncontrollable shaking, vomiting beginning around 8:00 PM, Tylenol did not reduce fever, went to ER and was admitted post chest x-ray, CT scan, dopplers. While admitted was treated for adverse reaction and pneumonitis diagnosed in ER. Treatment included iv fluids, iv antibiotics (Rocephin), magnesia, potassium, anti-nausea mediation, breathing treatments, Lovenox injections, blood draws for labs multiple times per day.
49 2021-01-24 feeling hot I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face ... Read more
I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face has been sunburned. It is red and slightly puffy. No new skin products or foods. No difficulty breathing or other symptoms. I am also a nurse practitioner.
49 2021-01-24 numbness Facial numbness that started at the hard palate then across cheekbones then upper lip. Numbness pers... Read more
Facial numbness that started at the hard palate then across cheekbones then upper lip. Numbness persisting but is better when taking vitamins. Seems worse in afternoon
49 2021-01-24 tenderness Swollen lymph node/gland w/ tenderness in the left arm Pitt
49 2021-01-25 inability to speak ? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat... Read more
? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat, breathing difficulty, cough, aphasia-pt was not able to express her thoughts or needs, pt felt that her heart was beating slow, vomiting started next day and lasted for 4 days, self treatment immediately by pt- Benadryl 50 mg and albuterol inhaler, later Prednisone course by medical professional symptoms completely resolved after 5 days
49 2021-01-25 weakness 11:00 am feeling pain and could did not have any upper body strenght, severe body aches, nausea, chi... Read more
11:00 am feeling pain and could did not have any upper body strenght, severe body aches, nausea, chills, second day felt feverish and third day 100.2 fever low grade fever, head arce .
49 2021-01-25 weakness ON 1/21/21 DEVELOPED NAUSEA, BODY ACHES AND WEAKNESS. SHE CALLED HER DOCTOR, WHO TOLD HER TO WAIT OU... Read more
ON 1/21/21 DEVELOPED NAUSEA, BODY ACHES AND WEAKNESS. SHE CALLED HER DOCTOR, WHO TOLD HER TO WAIT OUT THE SYMPTOMS OR GO TO THE ER IF THEY GOT WORSE. SHE DID NOT GO TO THE ER.
49 2021-01-25 burning sensation Tightness in right jaw and neck; Burning sensation all over
49 2021-01-25 feeling hot I have a sudden "hot feeling" in arms and legs that started 2 days ago.
49 2021-01-25 numbness Facial numbness that started at the upper palate then progressed across the middle of the face
49 2021-01-25 migraine migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a con... Read more
migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142 and expiry date unknown) via unspecified route of administration at the left arm on 08Jan2021 13:45 at single dose for Covid-19 immunization in a hospital. Medical history included vestibular migraines, allergies to ragweed, and allergies to PCN (penicillin). The patient was not pregnant. The patient has no covid prior vaccination. Concomitant medications included amitriptyline hydrochloride (ELAVIL), propranolol hydrochloride (INDERAL), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC), riboflavin (VIT B2), and colecalciferol (D3) and multivitamins; all from unspecified date for unspecified indication. The patient has no other vaccine in four weeks. On day 1 (08Jan2021), the patient experienced sore arm injection site. On day 2 (09Jan2021), the patient experienced diarrhea once. On day 3 (10Jan2021), the patient experienced migraine, vertigo attack. On day 4 (11Jan2021) and 5 (12Jan2021), the patient was still little dizzy. The patient did not receive treatment due to the events. The outcome of the events sore arm injection site, diarrhea, migraine and vertigo was recovering, while dizzy was not recovered.
49 2021-01-25 tenderness First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.;... Read more
First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.; swollen lump nose; swollen lump nose; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular in right arm on 07Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included valley fever treatment for 4 months. No known allergies. Concomitant medication included fluconazole. On 07Jan2021 18:00, the patient experienced first day-headache, second day feeling unwell, and third day tenderness/ swollen lump nose, lymphadenopathy, right underarm. Patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Treatment received for the events included TYLENOL tabs. The outcome of the events was not recovered.
49 2021-01-26 night sweats, weakness I received the shot in the morning on Jan. 21, 2021 and had no issues until 12:20am (Jan 22)when I w... Read more
I received the shot in the morning on Jan. 21, 2021 and had no issues until 12:20am (Jan 22)when I woke up sweating profusely and had major chills. My body ached all over and had a hard time sleeping due to all of this the entire evening. I woke up and tried to get ready but quickly realized I was weak, my joints hurt, body ached, headache and couldn't do it. This continued throughout the morning and part of the afternoon. Then around 2pm, I was still tired and achy but my joints didn't hurt as bad and I was able to manage the headache with ibuprofen. The body aches continued through most of the next day (Jan. 23) as well. By Jan. 24th I was perfectly fine and back to normal. I had covid early in the year on Nov. 6 which kept me out of work for almost 3 weeks. These few days were very similar to how I felt when I had covid but not as intense.
49 2021-01-26 pain in extremity, weakness, numbness Severe shoulder and arm pain, weakness, numbness finger tips. Diagnosed with Parsonage Turner Syndro... Read more
Severe shoulder and arm pain, weakness, numbness finger tips. Diagnosed with Parsonage Turner Syndrome
49 2021-01-27 hot flush, tingling, muscle spasms, numbness I had headache that night, hot flashes, left arm, legs, and fingers had spasms and tingled, felt ver... Read more
I had headache that night, hot flashes, left arm, legs, and fingers had spasms and tingled, felt very tired. The next day my throat was a little sore and I felt tired. On the 20th I awoke to my face feeling like pins and needles, neck numb. I felt like my mouth was pulling down and I was drooling on my left side of face. The pins and needles stopped on the 27th after prednisone and Valacyclovir was prescribed on the 22nd. I still feel like I am drooling some but today the feeling is back in my jaw.
49 2021-01-27 pain in extremity Headache; body aches; fever; dizziness; sore arm; drowsiness; loss of balance; agitation; skin ach; ... Read more
Headache; body aches; fever; dizziness; sore arm; drowsiness; loss of balance; agitation; skin ach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date not provided), via an unspecified route of administration in the left arm on 15Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID, and allergies (unspecified). The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included unspecified medication. The patient experienced headache, body aches, fever, dizziness, sore arm, drowsiness, loss of balance, agitation, and "skin ach" on 15Jan2021 21:00. Treatment was not provided in response to the events. The patient has not undergone COVID test post vaccination. The outcome of the events was recovered with sequel on an unspecified date in Jan2021.
49 2021-01-27 tingling, numbness, weakness, pain in extremity Received 2nd dose vaccine on 1/22/21; woke up on 1/23/21 with mild headache by later in afternoon wi... Read more
Received 2nd dose vaccine on 1/22/21; woke up on 1/23/21 with mild headache by later in afternoon with generalized body aches. By early evening left arm tightness radiates to shoulder/shoulder blade/left chest and arm tingling sensation (as if pulled muscle) requiring icing area and Motrin; felt tired and lethargic; woke up Sunday with headache, ate breakfast and went back to bed till 2pm. Felt better as day progresses Sunday. Wednesday 1/27/21 left arm sore as if I received injection that morning. as day progresses soreness radiates to the shoulder and chest area, tingling resumes and by evening with numbness and nausea. Thursday 1/28/21 still with the tingling sensation and whole left upper arm and shoulder area tight with some weakness.
49 2021-01-27 tingling c/o receiving her second vaccine today and notice there was now a rash on her chest and she states s... Read more
c/o receiving her second vaccine today and notice there was now a rash on her chest and she states she is starting to feel tingling in her throat and bilateral arms Transferred to ED. Treated with epinephrine, solumedrol, benadryl and pepcid with resolution of symptoms
49 2021-01-27 tremor, feeling cold, discomfort Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable... Read more
Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable-she states, COLD, body aches, HA, nauseated, sweating, muscular & joint pain 27th Jan-decreased symptoms some, intermittent SOB, chest pain, rt & left sides 28th Jan-SOB-continues, -she has a history of seasonal allergies, Told to go to the ER if her SOB & chest pain gets worse. Took Tylenol & Motrin for the body aches, HA, joint pain and discomforts Can't walk-gets fatigued-even short distances
49 2021-01-27 tremor, feeling hot Feels hot; Fevers/Her temperature is currently 102 degrees; Shakes; Vomiting; Diarrhea; This is a sp... Read more
Feels hot; Fevers/Her temperature is currently 102 degrees; Shakes; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer reported for self. This 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142) via unspecified route of administration on 12Jan2021 at single dose in left arm for COVID-19 immunization. The patient worked front line in the emergency room (ER). The patient medical history included stage 4 metastatic melanoma from 2013. The patient concomitant medications included nivolumab (OPDIVO) for stage 4 metastatic melanoma. The patient previously received first dose of BNT162B2 (Lot: EJ1685) on 22Dec2020 at single dose for COVID-19 immunization and she didn't feel anything with that dose. The patient experienced shakes, fever, diarrhea, vomiting on 13Jan2021. The patient reported that she had been having shakes and fevers that started at 2:00 AM this morning 13Jan2021. Her temperature is currently 102 degrees on 13Jan2021. It was better but she let herself go 5-6 hours without taking anything. She had been alternating paracetamol (TYLENOL) and ibuprofen (MOTRIN). When it wore off she instantly felt hot and shaky. She also had started having diarrhea and vomiting. The outcome of the events was unknown.
49 2021-01-28 cold sweat BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse ... Read more
BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse (patient) reported that a 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKS730), via an unspecified route of administration on the right arm on 20Dec2020 11:15 at a single dose for Covid-19 immunization. Medical history included allergic rhinitis and atopic dermatitis both from an unspecified date. Patient is not pregnant. Concomitant medications included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), doxycycline, prednisone, and diphenhydramine hydrochloride (BENADRYL); all were taken from an unspecified date for an unspecified indication. The patient received the second dose of other vaccine (unspecified, Pfizer product, lot number: EK9231), via an unspecified route of administration on the right arm on 14Jan2021. On 20Dec2020 11:45, the patient had headache, cold sweats, shivering, and BP (blood pressure) 218/116. The patient called Rapid Response Nurse, and she was wheeled to the hospital E.R. The patient was seen by a doctor and opted to just monitor her BP, no medication or IV line started. The patient was discharged with SBP of 159. The outcome of the event BP (blood pressure) 218/116 was recovering while the rest of the events was unknown.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 11:15. On 20Dec2020 11:45, the patient had blood pressure high, 218/116 mmHg. Based on information available, the reported high blood pressure was probably causally related to the first dose of BNT162B2, considering the plausible temporal relationship, and clinical course. However, the concomitant medications, especially prednisone, for unspecified indications, could be confounding factors. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-01-28 feeling cold, weakness Unusually cold, very lethargic, achy(mostly in legs), generalized weakness within 12 hours of vaccin... Read more
Unusually cold, very lethargic, achy(mostly in legs), generalized weakness within 12 hours of vaccination. The majority of these symptoms resolved by 11:00 PM EST on 1/28/21. Around this time head became stuffy with a headache. Headache and stuffy head are continuing to the present moment on 1/29/21. Some lethargy also noted.
49 2021-01-28 pain in extremity Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my enti... Read more
Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my entire right arm. I was only able to lift my arm up to my shoulder. Very fatigue, body aches, dizziness and drunken feeling. Day 3: less arm soreness. Very fatigued and dizzy. Body aches, joint and muscle pain. Pain in my body. Day4: muscle and joint pain, still very fatigued and my vision began to become blurry. Day 5: fatigue, joint pain, headache and blurred vision has worsened. Day 6: fatigue joint pain, sever headache, dizzy, vision is still bad. I contacted the ophthalmologist and Optometry to schedule an appointment.
49 2021-01-28 pain in extremity At night on the day of the vaccine I started with a headache, a dull headache, nothing sharp, really... Read more
At night on the day of the vaccine I started with a headache, a dull headache, nothing sharp, really tired and my body was achy. My left arm was sore. The next day roughly the same symptoms throughout the day, really tired and just kinda achy. On a Holiday after I had the vaccine, when I took the ibuprofen, my husband realized he lost his sense f taste and smell and he realized he was the same way the day before. He got tested Saturday the day after the Holiday and since I was still achy on Saturday I called employee health and they told me to get tested. I was tested through Employee Health ( employee only testing site). I still get tired really quick, I get winded really quickly even after doing chores at the house, like laundry and even if I am sitting still, I still sometimes am short of breath. The dull headaches are still present. I had lost my sense of taste and smell but those came back.
49 2021-01-30 flushing My bp went up to 182/101 a couple hours after vaccine., had a bad headache, tired and flushed feelin... Read more
My bp went up to 182/101 a couple hours after vaccine., had a bad headache, tired and flushed feeling. Had to take BP meds again n lay down, seemed to go down after an hour of taking BP meds to 140/89
49 2021-01-31 migraine I had severe headaches for the first 5 days that Tylenol would not help. One day, I had what I woul... Read more
I had severe headaches for the first 5 days that Tylenol would not help. One day, I had what I would consider a migraine (light and sound were painful). I also had bubbly feelings in my stomach that came in waves. The headaches have gotten better in the last 2-3 days.
49 2021-01-31 pain in extremity, feeling hot woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; head... Read more
woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; headache 6/10 /My head hurt so bad 10/10; thought I would throw up; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; muscle and bone aches; muscle and bone aches; I was just crying; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3302, intramuscular in the left arm on 18Jan2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 vaccination. Medical history included hyperthyroidism from an unknown date. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included Levothyroxine, Liothyronine, CoQ10, McIntyre Vit D, and Probiotics all from unspecified dates for unspecified indication. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, intramuscular in the left arm on 28Dec2020 at 09:00 as a single dose for COVID-19 vaccination. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2021 at 12:30, the patient experienced writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch. This morning just muscle and bone aches and headache 6/10. The patient did not receive treatment for the events. The clinical outcome of the events writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
49 2021-01-31 pain in extremity My arm got sore; Body ache; Low grade fever; I kind of lost my appetite; Extreme fatigue; This is a ... Read more
My arm got sore; Body ache; Low grade fever; I kind of lost my appetite; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283, Expiration Date: 30Apr2021), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. Patient had second Pfizer vaccine last Wednesday morning (13Jan2021) and went to work that day and was fine. Her arm got sore but that was fine and that night around like 10:00 pm, patient got like body ache and low-grade fever and patient was kind of lost appetite and that went on for about a day and a half. But patient had continued extreme fatigue and patient was wondering if that was part of the (sentence incomplete), several days later, it was four days later. Patient just expected it, but it was a little way more. Patient received paracetamol (TYLENOL) as treatment. Outcome of extreme fatigue was unknown. Outcome of other events was resolved after about a day and a half.
49 2021-01-31 pain in extremity Sick; woke up 12 hours later and had a temp of 102 and arm pain/ temp gotten as high as 103 degrees ... Read more
Sick; woke up 12 hours later and had a temp of 102 and arm pain/ temp gotten as high as 103 degrees Fahrenheit; arm pain; sweating; she was really tired; This is a spontaneous report from a contactable nurse. This 49-year-old female nurse reported for herself that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982) at single dose for Vaccination on 14Jan2021. The vaccine was injected to left deltoid/shoulder about 2:15 pm. Relevant medical history included ongoing uterine fibroids since Dec2019, ongoing obesity since Oct2000 and COVID-19 from Dec2020 to Dec2020. Relevant concomitant drug was unknown. The patient had surgical procedures when she had her first child. No Family Medical History Relevant to AE(s). Her mother got the shot a couple of days before caller did and she had no problems. The patient was administered her first dose of Pfizer BioNTech COVID-19 Vaccine on 14Jan2021. She reported that she became sick (Medically significant) about 12 hours later on 15Jan2021. The patient Went to sleep and woke up about 12 hours after she got the Pfizer-BioNTech COVID-19 Vaccine with a body temperature of 102 degrees Fahrenheit and arm pain. She could not really go back to sleep. When she got up it went away. She tried to go to work that day, and did go to work but she was really tired. When she finally got home she got in the bed and really had not been out of bed since then except for today she was sitting in a chair; so she thought maybe she had improved a little bit at on the reporting day. She had maintained a constant fever since 15Jan2021 that had gotten as high as 103 degrees Fahrenheit. At the reporting time her temp was 100.5. She had alternated Tylenol and Motrin for the fever. She was sweating profusely so it may be the temperature trying to break, but she had been struggling since she had it. This was so unlike her, she did not just stay in bed. She could not kick it. She had been unable to work since 15Jan2021 and she had to work tomorrow. She believed this was medically significant because she cannot work. The patient did not have vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No Additional Vaccines was administered on Same Date of the Pfizer Suspect. Relevant Tests was None. The patient did not visit the emergency Room nor Physician Office due to the events. The outcome of event being sick was resolving. The outcome of event temperature had gotten as high as 103 degrees Fahrenheit was not resolved. The outcome of other events was unknown. The patient thought the causality was yes 100% because her COVID-19 symptoms were not even this bad; she never had a fever with COVID-19; and she had never before had a fever this high for this long.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the event; causality therefore cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-01-31 pain in extremity Lymph Node swelling under right arm pit and arm. Pain the radiated from there down to fingertips.
49 2021-01-31 pain in extremity Severe arm pain; unable to move arm without excruciating pain; This is a spontaneous report from a c... Read more
Severe arm pain; unable to move arm without excruciating pain; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231, expiry date not reported), via an unspecified route of administration on the left arm on 15Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included was not reported. Concomitant medication included ibuprofen, vitamin D NOS, magnesium and fish oil. The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on the right arm on 25Dec2020 for COVID-19 immunization. The patient experienced severe arm pain; unable to move arm without excruciating pain on 15Jan2021 15:00. The outcome of the event was unknown.
49 2021-01-31 tremor I started out feeling light headed with a little bit of a headache. As the day went on my legs and m... Read more
I started out feeling light headed with a little bit of a headache. As the day went on my legs and my back started to ache. My legs were so bad that you could not touch the back of them. I had a low grade fever. I also had the shakes and a runny nose. This lasted 24 hours. The fever and headache lasted 36 hours. After that all I was left with was a runny nose. My job all made me get a COVID test and that came out Negative.
49 2021-02-01 migraine COULD NOT LIFT LEGS TO GET INTO BED, OR HARDLY WALK IT WAS SO PAINFUL AND LOW BACK PAIN, MIGRAINE, F... Read more
COULD NOT LIFT LEGS TO GET INTO BED, OR HARDLY WALK IT WAS SO PAINFUL AND LOW BACK PAIN, MIGRAINE, FUZZY HEAD, DIZZY, LACK OF APPETITE, FATIGUED (SLEPT ALL DAY STARTING AT 3 PM DAY OF VACCINE TO ALL WAY NEXT DAY AND NIGHT), VERY ACHEY, COULD NOT LIFT MY RIGHT ARM, BRUISE WHERE INJECTION WAS GIVEN ALONG WITH A KNOT. TODAY IS 2.2.21 AND STILL FEEL FUZZY HEAD AND ACHEY.
49 2021-02-01 tingling Vaccination day was Sunday. Sunday evening developed chills and malaise which lasted thru Monday mid... Read more
Vaccination day was Sunday. Sunday evening developed chills and malaise which lasted thru Monday mid-day. Monday night noticed canker sore on the gums in the mouth which gradually resolved over the course of the next few days. On Thursday I noticed a small rash on the left side of my upper back. Within next 48-72 hrs multiple blistery patchy rashes developed on the left lower back, hip and groin. The rash is painful and tingly. Dr. visit on Tuesday (2/2/21) diagnosed/confirmed shingles. Valacyclovir was prescribed by MD.
49 2021-02-02 muscle twitching, feeling hot When the vaccine was administered, I felt a warm sensation move up my neck and then approx 3 hours l... Read more
When the vaccine was administered, I felt a warm sensation move up my neck and then approx 3 hours later I started having left sided facial muscle twitching. Then I started having muscle twitching all over my body. To this day (3 weeks after vaccine) I am still having muscle twitching. It has improved some.
49 2021-02-03 weakness, night sweats, tenderness Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painf... Read more
Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painful lymph nodes-to neck and groin and around sides; low grade fever; abdominal pain one day; all days lymph nodes pain /neck lymph node aches/ severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness, especially around the side rib cage and waist area; tenderness especially around the side rib cage and waist area/ severe tender and painful lymph nodes-to neck and groin and around sides; feeling really bad like i want to cry; slight headache; night sweats; rapid heart rate; increased blood pressure; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness to flank area; difficult to turn in bed and lie on right side; Itchiness but no visible rash; first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration at the right arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included taking medication for focus (adult adhd?); perimenopausal. She also has known allergies: sulfa; shrimp, strawberry/raspberry flavored foods or candies. The patient was not pregnant at the time of vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for focus, perimenopausal. The patient previously received the first dose of bnt162b2 intramuscularly at the right arm on 28Dec2020 at 2:30 PM at the age of 49 years for COVID-19 immunization (Lot number: EL3249). On 15Jan2021, the patient experienced weakness, fatigue, small breathes like slightly short of breath/ short of breath, body aches, low grade fever, abdominal pain one day, all days lymph nodes pain and tenderness especially around the side rib cage and waist area, more on right side then left, neck lymph node aches, feeling really bad like the patient wanted to cry, slight headache, night sweats. Lymph node pain and tenderness is the worse along with body aches and weakness. Also, on 15Jan2021, patient experienced rapid heart rate, increased blood pressure, severe tender and painful lymph nodes-to neck and groin and around sides, under ribs and tenderness to flank area. Mainly right below right ribs and right waist, right flank painful and difficult to turn in bed and lie on right side. There were also Itchiness but no visible rash. According to the reporter the events started on 15Jan2021 at 1AM. The patient received the first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021. The patient had nasal swab, rapid on18Jan2021 result was negative and nasal swab on 20Jan2021 result was negative. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering except for abdominal pain one day which recovered on 16Jan2021.
49 2021-02-03 burning sensation, numbness numbness for an hour; burning sensation; joint pain; This is a spontaneous report from a non-contact... Read more
numbness for an hour; burning sensation; joint pain; This is a spontaneous report from a non-contactable consumer reporting on behalf of the patient. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness for an hour, and subsequently burning sensation and joint pain which subsided with Tylenol use. The patient was recovering from the events burning sensation and joint pain, while unknown outcome for the remaining event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
49 2021-02-03 facial paralysis was supposed to get the second dose yesterday 19Jan2021 but location is closed/ could get it up to ... Read more
was supposed to get the second dose yesterday 19Jan2021 but location is closed/ could get it up to the 26Jan2021; paralysis of the chin and half of the face; and around the mouth; This is a spontaneous report from a contactable consumer report for self. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 29Dec2021 20:00 PM for COVID-19 immunization. Medical history included ongoing severe migraines. None family history. There were no concomitant medications. No Prior Vaccinations within 4 weeks. After an hour she had paralysis of the chin and half of the face; and around the mouth. It only lasted a few minutes, like 10 minutes and then it went away, she was fully recovered. She did not got to a doctor or the ER. Adds she was supposed to get the second dose yesterday 19Jan2021 but she has to go to another location as that location is closed. They told her she could get it up to the 26Jan2021 and then it would be more problematic to get. The event outcome was recovered on 29Dec2020. Information on the lot/batch number has been requested.
49 2021-02-03 feeling cold Feeling like I have a bad cold. Exhausted, headache, lethargic, stomach ache, no fever. Started the ... Read more
Feeling like I have a bad cold. Exhausted, headache, lethargic, stomach ache, no fever. Started the morning after I received the first vaccine
49 2021-02-03 pain in extremity Received Pfizer vaccine on 2/2/2021, noticed that left hand was achy and swollen on 2/3/2021 and on ... Read more
Received Pfizer vaccine on 2/2/2021, noticed that left hand was achy and swollen on 2/3/2021 and on 2/4/2021, she noticed that her right hand was swollen.
49 2021-02-03 pain in extremity Difficulty swallowing, swollen uvula, rash in ~15-20 minutes Benadryl (self administered), Epinephri... Read more
Difficulty swallowing, swollen uvula, rash in ~15-20 minutes Benadryl (self administered), Epinephrine & steroids (ED) 4 hours post epinephrine observation Headache, arm pain and lethargy the following day
49 2021-02-03 pain in extremity Left lower quadrant pain; Nausea; Fatigue; arm pain; she felt like she caught ' a bug' or 'flu-like ... Read more
Left lower quadrant pain; Nausea; Fatigue; arm pain; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; This is a spontaneous report from a contactable healthcare professional (patient herself). A 49-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 at 0.3 ml, single for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced arm pain on 08Jan2021, fatigue on 09Jan2021, nausea on 10Jan2021, left lower quadrant pain on 11Jan2021. The patient said that she felt like she caught "a bug" or "flu-like symptoms" after her first dose of the COVID vaccine. She would like to know if she should get the 2nd dose of the COVID vaccine after experiencing flu-like symptoms after her first dose. Therapeutic measures were taken as a result of nausea and left lower quadrant pain that included ciprofloxacin and metronidazole. Clinical outcome of arm pain was not recovered; for fatigue and nausea was recovering; for left lower quadrant pain was recovered on an unspecified date; while for the other events was unknown.
49 2021-02-03 tingling feel prickly; both arms broke out in raised hives and rash; both arms broke out in raised hives and ... Read more
feel prickly; both arms broke out in raised hives and rash; both arms broke out in raised hives and rash; This is a spontaneous report from a contactable consumer (patient). A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on the left arm on 14Jan2021 at 13:00 at a single dose for COVID-19 Immunization. Medical history included severe asthma, depression, anxiety, sinus problems, and known allergies with Penicillin and intravenous (IV) iodine. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and aripiprazole (ABILIFY). The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. About 15 minutes after the shot, on 14Jan2021 at 1330 hours, the patient started to feel prickly and both arms broke out in raised hives and rash. Treatment for the events included intramuscular (IM) 50mg Benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included nasal swab: negative on 14Nov2020. The events resolved in Jan2021. Information on the lot/batch number has been requested.
49 2021-02-03 seizure Systemic: Anaphylaxis-Severe, Systemic: Fainting-Severe, Systemic: Seizure-Severe
49 2021-02-04 breast pain about an hour after shot: Numbness on back of tongue, extreme tiredness. Took about an hour nap. Wok... Read more
about an hour after shot: Numbness on back of tongue, extreme tiredness. Took about an hour nap. Woke up feeling better. Appx 3 days later ( 1/15/2021) from shot, soreness in both breasts. This symptom lasted for about a total of 1 week from date of noticing. 1/22/2021.
49 2021-02-04 breast pain A little over an hour after shot: Numbness on back of tongue, lasted about 1 hour after shot 3.5 hou... Read more
A little over an hour after shot: Numbness on back of tongue, lasted about 1 hour after shot 3.5 hours after shot: Swelling and small lump formed on left wrist, last appx 16 hours 2 days after shot: Small lump and soreness along the left collar bone area, lump, soreness still ongoing (as of 2/5/2021, date of this report) 2 days after shot: Soreness in both breast, still ongoing (as of 2/5/2021, date of this report)
49 2021-02-04 feeling cold discomfort in her chest vs the burning/ chest discomfort; discomfort in her chest vs the burning/whi... Read more
discomfort in her chest vs the burning/ chest discomfort; discomfort in her chest vs the burning/while the chest discomfort had subsided the burning was back; burning in her lungs; coldness/ all over body coldness; fatigue; chills; This is a spontaneous report from a contactable consumer (patient herself, a medical assistant) via Medical Information team. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231, expiration date: 30Apr2021), via an unspecified route of administration on the right deltoid on 13Jan2021 at 12:30 at a single dose for COVID-19 immunization. The vaccination facility was the clinic. Vaccine was not administered at a military facility. Relevant medical history included sleeping (problem). Concomitant medications included ongoing trazodone as a sleeping pill and an unspecified multivitamin. The patient had no previous immunizations with a Pfizer vaccine as this was the first dose. She had no prior vaccinations within 4 weeks. The patient was having concerns about the side effects was experiencing after her first dose. The patient received the first dose on 13Jan2021 and afterwards she felt fatigue on 13Jan2021; coldness on 14Jan2021 at 07:30; and chills on an unspecified date in Jan2021. On Tuesday, on 19Jan2021, she started having "burning in her lungs" then the day prior reporting, on 20Jan2021 was a vigorous day at work and she had discomfort in her chest versus (vs) the burning." She stated that at the time of the report (21Jan2021), she was working at home and while the chest discomfort had subsided, the burning was back. The patient was asking if this was normal or expected and she didn't call her doctor; she was asking what should she do. The patient further reported that she did have some common side effects and the some of them were the normal ones such as: fatigue, chills, and feeling cold for a few days. The patient further reported that all over body coldness occurred at 7:30 AM on 14Jan2021; she noticed it shortly after she woke up. She actually noticed it after drinking coffee and then it was like the coldness kicked in. It would get worse as she drank things. It did not matter if it was hot or cold things. It was like the hot things intensified the cold feeling. At the time of the report she was having more concerning symptoms. On Tuesday (19Jan2021), she started to have burning in her lungs and the day prior reporting (20Jan2021) at work, she had chest discomfort. It was a little busy day at work running around on the floor. The chest discomfort was nothing significant, but it was a discomfort, especially on the left side. She confirmed she did not have that discomfort at the time of the report. However, she was having the burning again. She was having concerns and wanted to speak to someone about this. She went on to explain she noticed the fatigue during the night on the day she got the vaccine. It resolved around 16Jan2021. She added she had all over body coldness. She confirmed this was the same as the chills and feeling cold. This feeling comes and goes. She added, it was also winter so it was really hard to tell what it was from. The first two days, she had this chills, cold feeling for two days straight. However, at the time of the report it was better. The chest discomfort started the day prior reporting; however, she was doing a lot of activity and she did not have it today. At the time of the report, she was sitting all day working from home. However, the burning was back. The adverse events did not require any visit to an emergency room or a physician office. She stated she thought about calling the doctor's office, but she had not called them yet. She knew they probably won't be able to help or tell her anything. The patient had no investigation assessment and no relevant test. The patient recovered from the event "fatigue" on 16Jan2021; she was recovering from the events "coldness/ all over body coldness and chills," she was not recovered from the event "burning in her lungs," while the outcome of the events "discomfort in her chest vs the burning/ chest discomfort /while the chest discomfort had subsided the burning was back" was unknown.
49 2021-02-04 flushing Pfizer-BioNTech COVID-19 Vaccine EUA She has h/o anaphylaxis to flu vaccine and 5 minutes after CO... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA She has h/o anaphylaxis to flu vaccine and 5 minutes after COVID vaccine she experienced SOB, throat and tongue itching, flushing, very anxious, her BP 144/102, HR 120s, RR 20. She had Epi-pen and we injected it for her per her request. She transferred herself to a wheel chair and went to ER with Crisis Nurse. Symptoms resolved. Patient discharged from ED.
49 2021-02-05 weakness pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt prese... Read more
pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt presented to my office on 1/25/21 she had confusion, memory loss, labial bp, relative hypotension, bradycardia, severe fatigue, muscle pain and weakness, barely able to rise from a chair or walk, also reported HA, diarrhea, hiccups,decreased O2 sat to a low of 91%-her baseline is 98-100%, she developed a rash after her appointment with me.
49 2021-02-05 feeling hot, flushing, tremor Five minutes after receipt of vaccine, patient c/o dizziness, hot, flush, shaking, nausea. Gave Be... Read more
Five minutes after receipt of vaccine, patient c/o dizziness, hot, flush, shaking, nausea. Gave Benadryl 25 mg PO @ 1214. 1215 Shaking and other s/s resolved. 1220 All symptoms resolved and decline ambulance nor visit to the hospital. 1237 All s/s resolved and left site.
49 2021-02-05 numbness Developed numbness of the right side of face about 20 minutes after receiving her vaccine. She went ... Read more
Developed numbness of the right side of face about 20 minutes after receiving her vaccine. She went to the ED to e evaluated. Symptoms resolved on their own after 2.5 hours and no other symptoms developed.
49 2021-02-06 pain in extremity Pt. reports intense right shoulder pain within 4 hours of receiving the vaccine and inability to mov... Read more
Pt. reports intense right shoulder pain within 4 hours of receiving the vaccine and inability to move her right shoulder properly. The pain extends into the neck bilaterally, right trapezius, and into the right hands. Pt. reports she feels like she can't grasp things properly with her right hand.
49 2021-02-07 facial paralysis Bells Palsy; This is a spontaneous report from a contactable Other HCP(patient). A 49-years-old fema... Read more
Bells Palsy; This is a spontaneous report from a contactable Other HCP(patient). A 49-years-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular on 05Jan2021 19:00 at the 49 years old at Arm Right at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medications were none. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient experienced Bells Palsy on 20Jan2021 15:00. The event caused Physician Office Visit. The patient received Steroids and viral antibiotic as treatment for the event. There was no COVID prior vaccination. There was no COVID tested post vaccination. There were none known allergies. The outcome of the event was not recovered. The information on the batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event Bell's palsy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-02-08 pain in extremity 1st dose vaccine 1/7/21; 2nd dose vaccine 1/28/21; developed low back pain radiating to left leg wor... Read more
1st dose vaccine 1/7/21; 2nd dose vaccine 1/28/21; developed low back pain radiating to left leg worse with movements no injuries onset 2/8/21; was seen in same day 2/8/21.
49 2021-02-08 pain in extremity Sore arm and slight headache.
49 2021-02-09 burning sensation Mild Headache and a rash that started on my lip and spread to my cheek, my eye and forehead. The ras... Read more
Mild Headache and a rash that started on my lip and spread to my cheek, my eye and forehead. The rash it blistery kind of looking, little bit blister and they would open and bleed and then close back up. It was also burning. It start continually spread more. I went yesterday 02/09/2021to a Dermatologist he treated me for a contact kind of dermatitis as if he was unsure if it was linked to vaccine or not. He gave me two steroid injections in the office and prescribed a cream Elidel 1% . The medications seem to be clearing up my face today.
49 2021-02-09 hot flush, flushing, feeling cold Very Flush; hot/cold flashes; hot/cold flashes; mild headache; sore at injection site; This is a spo... Read more
Very Flush; hot/cold flashes; hot/cold flashes; mild headache; sore at injection site; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, lot number=EL9261), via an unspecified route of administration on 23Jan2021 14:45 at single dose at left arm for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included allergies to sulfa, mold, asthma, multiple sclerosis, anemia. Concomitant medication included dimethyl fumarate, chorionic gonadotrophin (PROVIGIL), clonazepam, modafinil and Fl. The patient previously took Wellbutrin and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced very flush, hot/cold flashes, mild headache, sore at injection site on 23Jan2021 17:00. The outcome of the events was recovered in Jan2021. No treatment received for the adverse events.
49 2021-02-09 pain in extremity, tingling 30 hours post second dose of Pfizers- Biontech COVID-19 vaccination EUA I noted left arm tingling ... Read more
30 hours post second dose of Pfizers- Biontech COVID-19 vaccination EUA I noted left arm tingling /altered sensation down to fingers. Headache, Left foot/heel pain/ weak knees, fatigue/temp 100 , left flank pain and bladder incontinence over night. Headache continued during the day and evening of 2/10/21, I also did have some transient pins/needles to both hands after dose 1 but thought it was related to sleeping position....then this developed after 2nd dose and I started becoming concerned this was a neurological/nerve related side effect of vaccination.
49 2021-02-09 tingling, muscle spasms, pain in extremity Headache, fatigue, tingling in hands, pain and spasms in hands, pain in left leg.
49 2021-02-09 tingling severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; severe nausea and vomiting... Read more
severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; Chills; body aches; tired and slept all day; Tingling at fingertips; This is a spontaneous report from a contactable consumer(patient). The 49-year-old female patient(not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot: EL3247), via an unspecified route of administration at left arm on 11Jan2021 16:30 at single dose for covid-19 immunisation. Medical history included hashimotos disease, allergy to penicillin and sulfa, tree nut intolerance. There was no COVID-19 Prior to vaccination. Concomitant medication included levothyroxine sodium (UNITHROID), ethinylestradiol/levonorgestrel (ENPRESSE). There was no other vaccination within 4 weeks prior to the COVID vaccine. On 22Jan2021, 04:00, The patient woke up with severe nausea and vomiting/diarrhea, lasted for the morning, she also experienced chills and body aches. By noon she was fine but tired and slept all day. She also experienced tingling at fingertips. That was all done by night. There was no treatment. Outcome of events was recovered in 22Jan2021. Events were assessed as non-serious. Since the vaccination, the patient had not been tested for COVID-19.
49 2021-02-10 weakness, night sweats That evening after my 2nd injection of the vaccine I became extremely weak and achy. I went to bed ... Read more
That evening after my 2nd injection of the vaccine I became extremely weak and achy. I went to bed and had chills, fever, and night sweats. I woke up with a bad headache that lasted 24 hours and the weak, achy feeling was still present for a couple more days. Those feelings eventually went away but I still felt very tired and drained for the next several days.
49 2021-02-10 weakness, tremor I woke up about 4am on the 8th I had fever and chills and shaky, temp was 100.5 nauseous, weak, diz... Read more
I woke up about 4am on the 8th I had fever and chills and shaky, temp was 100.5 nauseous, weak, dizzy, I called into work, I assumed the shot was working. I called my physician to let her know I was having a reaction, I diarrhea for 3 days . I just took some tylenol and after the 3 days I started feeling better
49 2021-02-10 feeling cold, numbness Shortly after I felt very dizzy, light headed and felt numb all over. I developed heart palpatation... Read more
Shortly after I felt very dizzy, light headed and felt numb all over. I developed heart palpatation. I was laid down and was very nauseous, cold, had a headache and got cotton mouthed. I had an elevated HR and BP as well. I laid there for about 30 minutes and finally the all symptoms except the headache subsided and it finally went away after day 3.
49 2021-02-10 feeling cold, pain in extremity, tremor Started with brain fog, unable to focus, fatigue, chills and body aches. Continued to progress to t... Read more
Started with brain fog, unable to focus, fatigue, chills and body aches. Continued to progress to temp 101.8, shaking chills, EXTREME arm pain, upper back pain, chest pain, wheezing, SEVERE headache, nausea, vomiting, diarrhea, EXTREMELY swollen axillary lymph nodes enlargement. Symptoms started approx 2 hours after injection and proceeded for 6 days then started to slowly improved then resolve.
49 2021-02-10 feeling hot Patient states that from her ears to her throat feels tight, she is hot and ear ache as well, feels ... Read more
Patient states that from her ears to her throat feels tight, she is hot and ear ache as well, feels yucky all of sudden. My tongue and throat feel fat and weird. Exactly like when she eats shrimp
49 2021-02-10 pain in extremity She said that she rarely gets sick; A soreness in her throat and it was hard to swallow; A soreness ... Read more
She said that she rarely gets sick; A soreness in her throat and it was hard to swallow; A soreness in her throat and it was hard to swallow; The feeling of a tooth ache/ having a toothache currently; Felt like someone punched her arm; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in upper right arm on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included seasonal allergy. There were no concomitant medications. The patient experienced a soreness in her throat and it was hard to swallow, in which she had to get ice to help alleviate the pain in her throat. The pain in her throat resolved a couple of hours later (as reported). She wanted to know if these side effects were from the vaccine. She also reported the feeling of a tooth ache today (26Jan2021), in which she tried to medicate with Tylenol, but was not able to access any while at work. Patient asked what symptoms do people experience within 15 minutes if they have an allergic reaction to the vaccine. The patient got the vaccine 5-6 days ago, but today (26Jan2021) she was on the job in a group setting and was having difficulty swallowing and had a sore throat. She said that she treated it with ice and it is slowly subsiding. She noticed she almost had a like a headache type thing, but it was in the back of the throat. She has had tingling in the back of her throat from seasonal allergies, but nothing like this. Her temp was 97.9 and it was now 98.3. As she swallows, she is feeling pain. She said that the ice helped out. She is having a toothache currently too and stated that she needs to go to the dentist. She noticed her sore throat while she was talking and noticed the sore throat and it hurt and when swallowing. She said that after the injection, she felt like someone punched her in the arm the next day on 22Jan2021. This has resolved at this time. She said that she rarely gets sick. This is the second time she has had some type of symptoms within 2 years. She said that she has not been around anyone and is social distancing. Treatment received for "a soreness in her throat and it was hard to swallow" included ice. The outcome of the events "a soreness in her throat and it was hard to swallow" was recovering (as reported), for event "felt like someone punched her arm" was recovered on an unspecified date and the rest of the events was unknown. Information on the Batch/Lot number has been requested.
49 2021-02-10 tremor Shaking chills Low grade fever Fatigue
49 2021-02-11 facial pain The late afternoon/evening on the day of the shot, my right side of my face, head, and neck felt sor... Read more
The late afternoon/evening on the day of the shot, my right side of my face, head, and neck felt sore. The next morning when I woke up, my right jaw joint was extremely inflamed and so much so that I could not bite down and my teeth did not touch or fit together. The pain was so bad and I had such limited movement of that area that I couldn't even move my tongue out to lick my lips. Then on Sunday, the pain was even worse and I could still not touch any teeth together and my bite was so off that my lower teeth did protrude out beyond my upper teeth. I went to the doctor the next day (Monday) in which he gave me a prescription for Meloxicam to reduce the inflammation. I had taken ibuprofen the days prior with no effect at all. Meloxicam did not work that much better but did reduce the inflammation a little bit. It was not until Thursday of that week (6 days after vaccine) that the inflammation was reduced enough to actually chew. MY front teeth touched together first and then the other teeth over the next couple of days.
49 2021-02-11 feeling hot, seizure I am the patient and within five minutes I got extremely hot my hearing started to leave me and then... Read more
I am the patient and within five minutes I got extremely hot my hearing started to leave me and then I passed out I don?t know how long I was out for but staff that were there said I was having a seizure shaking and making gurgling sounds in my throat when I came to I could see people but my hearing took longer to come back. I was then brought to Midstate hospital via ambulance at Midstate I had an EKG and blood work done as well as blood pressure monitored and blood oxygen levels
49 2021-02-11 tremor, discomfort 2/10/21 Headache started at 7pm and progressively got worse. Achy joints and muscles began at 9pm. A... Read more
2/10/21 Headache started at 7pm and progressively got worse. Achy joints and muscles began at 9pm. At 11:30pm I was shaking in bed, low-grade fever, teeth-chattering, muscles tense, couldn't get comfortable. Got up to take Tylenol about 12am. Legs were weak, hands/arms shaking. Took two Tylenol and 4 Advil. Became more comfortable and last looked at the clock at 2am. Woke up with flu aches... Body aches, skin sensitivity. This lasted until 10-11pm on 2/11/21. Woke up 2/12/21 with no symptoms.
49 2021-02-12 flushing, tingling Head to toe tingling, lightheaded, chest tightening, throat constriction, flush.
49 2021-02-13 tingling Tingling, pins and needles on palm Observed water 183/90 HR 67
49 2021-02-14 muscle twitching At around noon 2/11/21 i began getting a headache and took prescription strength Tylenol, by 730pm I... Read more
At around noon 2/11/21 i began getting a headache and took prescription strength Tylenol, by 730pm I started having chills and couldn?t get warm, eventually just going to bed. Through out the night I was sweating and experienced awful body aches and twitching. I woke up on 2/12/21 at 6:00am with a 100.4 temperature and slept until about noon at which time I had 101 temperature and then continued to sleep until 5p, still having a fever of about 100. I then slept until around 830am 2/13/21, still experiencing twitching, body aches and sweating. When I woke on 2/13/21 I had no fever, but still achy and in a ?fog?.
49 2021-02-15 tingling, feeling of body temperature change, migraine Woke up to a severe migraine, felt like vomiting but couldn?t (dry heaves), chills...no fever althou... Read more
Woke up to a severe migraine, felt like vomiting but couldn?t (dry heaves), chills...no fever although felt hot/cold, upset stomach (diarrhea), and tingly face
49 2021-02-16 numbness, burning sensation pain/burning sensation in right shoulder joint, numbness in elbow, and sometimes into forearm and f... Read more
pain/burning sensation in right shoulder joint, numbness in elbow, and sometimes into forearm and fingers on right hand
49 2021-02-16 numbness About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very ver... Read more
About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very very dizzy. I got up and showered and my feet swelled very bad. I did not feel well but I went to work but the feelings never got better. So on 1/10 Sunday I went to the medical center because I jjust didnt not feel well. The swelling in the lower legs was still there so I was prescribed 20 mg of presnisone for 5 days. The sound changed during the time of the antibotics but after I stopped taking the prednisone the ringing sound came back, my left foot is still numb and my eyes are constantly red and burning even after putting drops in my eyes, I still suffer from headaches and if I turn my head too far left or right I get dizzy still to date. On 1/14 I was given a 60 mg dose of tapered predinosone for 2 week to help elevate the symptoms but it did not work. On 2/12 I saw an ENT specialist who performed a hearing test which did produce minor hearing loss and was diagnosed with having Tinnitis.
49 2021-02-16 migraine Soon after shot my lips tingled and I got really tired so I knew I was having a slight reaction. Th... Read more
Soon after shot my lips tingled and I got really tired so I knew I was having a slight reaction. That was it until later that night I started getting a really bad headache/migraine. I started taking Tylenol but that didn't help much. I got chills and I'm sure a slight fever because I was sweating. I started throwing up also.. After taking Tylenol every 4 hours my headache finally went away and I started to feel better. This was around 2:30 pm the following day. I would say my symptoms lasted for about 22 to 24 hours.
49 2021-02-16 muscle spasms I had muscle spasms and trouble walking before I got the vaccine. I gave it some time. The morning b... Read more
I had muscle spasms and trouble walking before I got the vaccine. I gave it some time. The morning before I had a light headache. After the vaccine my headache, and muscle spasms got worse. It lasted for days. Yesterday the headache was a little less. As of this morning my neck was hurting. Thursday and Friday the headache did not go away at out. Saturday it was coming and going. I was trying to put ice on it and run the water from the shower on it. Thursday , Friday and Saturday I was vomiting. Friday I went to Urgent Care, the doctor said a lot of patients were complaining about headaches. She gave it a few days. On the 15th of this week I seen my primary doctor, she said the same thing.
49 2021-02-16 pain in extremity Severe arm pain lasting almost two weeks
49 2021-02-16 tremor Muscle aches & pain to the bone; chills so bad I couldn't stop shaking for three hours no matter how... Read more
Muscle aches & pain to the bone; chills so bad I couldn't stop shaking for three hours no matter how many covers; full-head headache to the point I could barely open my eyes; lasted approximately 12-15 hours overall
49 2021-02-17 feeling hot, flushing Patient's face flushed, mouth got dry, and was feeling hot. She stated this reaction happens often ... Read more
Patient's face flushed, mouth got dry, and was feeling hot. She stated this reaction happens often because of her disorder, but in this case it lasted for an hour and she began to feel light headed and her heart rate was increased. She was given water and a cold compress, before ultimately was brought to an urgent care center by her family members who were present at the facility.
49 2021-02-17 flushing Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generali... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient experienced small pitchea on arms. Given 25 mg benadryl. Monitored additional 5 minutes, temperature increased, began to complain of bumps around neck. 0.3 mg epinephrine administered and BP monitored. Red rash began to form on face and neck. BP recorded as 99/39 mmHg. Paramedics arrived within 7 minutes of administering epinephrine.
49 2021-02-17 pain in extremity Unable to fully lift arm, intense/sudden pain with no factors causing it, wakes during sleep, OTC in... Read more
Unable to fully lift arm, intense/sudden pain with no factors causing it, wakes during sleep, OTC interventions not working
49 2021-02-18 bell's palsy, facial paralysis, tenderness Patient reported to the ER on Feb. 16th with onset of right-sided facial droop today about 1400. P... Read more
Patient reported to the ER on Feb. 16th with onset of right-sided facial droop today about 1400. Patient has no other weakness symptoms, bilateral extremity strength is equal. No forehead sparing on facial droop along with some tenderness and rhinorrhea. Symptoms are consistent with a Bell's palsy. Patient recently had Covid which fits with viral syndrome causing Bell palsy. Discharged with valacyclovir and prednisone burst. Follow-up and strict return precautions to the ED were discussed and patient verbalized understanding.
49 2021-02-18 numbness approximately 5 minutes after the injection my upper lip went numb along with my left side of my fac... Read more
approximately 5 minutes after the injection my upper lip went numb along with my left side of my face, primarily my upper cheek below my eye. Then it slowly moved to the top of my head and the top of my left hand. My heart was racing a bit, but that could be due to me being nervous about my face going numb. An attendant stayed with me until it started to subside, approximately 15 minutes later. Other side effects were mild the following day. A bit of a headache, fatigue and chills. Fatigue lasted a couple days but all minor.
49 2021-02-18 tingling tingling and pins and needles on the left side of face, slight numbness on bottom lip and bottom of ... Read more
tingling and pins and needles on the left side of face, slight numbness on bottom lip and bottom of the mouth. Slight swallowing problem. High blood pressure, dizziness, shivering. Got some Benadryl ( chewing tablet) from the paramedic on site. Went to the ED got more Benadryl, steroids and pepsid IV. Tingling subsided after 2 hours and numbness in the mouth too. Next day had major vertigo and heart rate was high and heart palpitations . Had some PVC which is still there. headaches come and go
49 2021-02-19 weakness High fever (up to 103 degrees) for three days, extreme muscle pain, joint pain, fatigue, brain fog, ... Read more
High fever (up to 103 degrees) for three days, extreme muscle pain, joint pain, fatigue, brain fog, nausea, joint pain, weakness
49 2021-02-19 feeling hot, flushing After vaccine patient reported feeling flushed, hot, dizzy, and nauseous. She was given and water an... Read more
After vaccine patient reported feeling flushed, hot, dizzy, and nauseous. She was given and water and banana. Vital signs normal. Then symptoms resolved. She was monitored by EMS for 30 minutes and then released home.
49 2021-02-21 facial paralysis Facial drooping, watering of the right eye, twitching of the right eye. Diagnosed as Bell's Palsey.... Read more
Facial drooping, watering of the right eye, twitching of the right eye. Diagnosed as Bell's Palsey. Rx for prednisone.
49 2021-02-21 pain in extremity, tingling RECEIVED BOTH DOSES OF PFIZER COVID-19 VACCINE ON 01/21/21 & 02/11/21. ON 02/21/21 REPORTED TO ER WI... Read more
RECEIVED BOTH DOSES OF PFIZER COVID-19 VACCINE ON 01/21/21 & 02/11/21. ON 02/21/21 REPORTED TO ER WITH COMPLAINT OF LEFT ARM PAIN (TINGLING, HEAVY SENSATION). DIAGNOSED WITH PARESTHESIA OF LEFT UPPER EXTREMITY, GOITER, AND DEGENERATIVE DISC DISEASE. DISCHARGED TO HOME SELF CARE.
49 2021-02-22 pain in extremity Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic S... Read more
Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic System
49 2021-02-22 tremor Tremors in arm afterward
49 2021-02-23 migraine Body aches, chills, migraine, 102 fever, nausea, vomiting.
49 2021-02-24 bell's palsy Numbness and tingling on R side of the face with drooping of eyelids and face currently on day7 diag... Read more
Numbness and tingling on R side of the face with drooping of eyelids and face currently on day7 diagnosed Bells Palsy
49 2021-02-24 muscle twitching 12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red... Read more
12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red. Felt like burning from the inside, out. Lightheaded and dizzy. Got puffy. Was NOT anaphylactic. 2 Benadryl. I didn't feel good for a couple weeks. 14-20 days, same experience with redness/burning. I took pictures. That happened every day for 4-5 more days. I went to doctor after doctor; ER after ER. About 6-7 times I have been to the ER; SOB, dizzy all the time, panic attack/anxiety, Stomach is not emptying correctly (NOT diabetic), eye keeps twitching, hurting behind my eyes, all my muscles are shrunken now. Blood panel, stress test; gastroparesis; positive; ringing in my ears; SOB; *COVID; negative.
49 2021-02-24 pain in extremity Pain and swelling in. arm Fever, low-grade Chills Achiness Fatigue Headache
49 2021-02-24 speech disorder Severe asthma attack, shortness of breath, unable to speak, wheezing. Patient given albuterol neb, e... Read more
Severe asthma attack, shortness of breath, unable to speak, wheezing. Patient given albuterol neb, epi pen, placed on cPAP and transported to hospital.
49 2021-02-24 tenderness Lymphadenopathy, neck tenderness + stiffness, even painful in places.
49 2021-02-24 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypert... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypertension-Medium
49 2021-02-25 flushing No side effects with 1st dosage. within 8 hours of 2nd dose side effects included: rapid heart rate... Read more
No side effects with 1st dosage. within 8 hours of 2nd dose side effects included: rapid heart rate, insomnia, body pain, joint pain, lower back pain, severe chills, upset stomach, nausea, headache. Within 36 hours, most of the side effects were gone, except headache. 3 days later - still have headache, and flush feeling all over body with mild sore throat (as of 2/26/21 @ 11:27 a.m.)
49 2021-02-26 feeling hot, flushing Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: she mentioned that thi... Read more
Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: she mentioned that this is a common reaction after vaccinations. she felt hot, sweat, nausea symptoms. nurse practioner on duty monitored her while she waited in the wait area for abour 20mins. she was feeling fine before she left. Rph called her about an hour and half later and she was back to normal.
49 2021-02-26 flushing 15 minutes after injection, I felt whole body flushing with tachycardia and palpitations that lasted... Read more
15 minutes after injection, I felt whole body flushing with tachycardia and palpitations that lasted for 5 minutes. The symptoms resolved and then 15 minutes later, the same symptoms occurred and lasted 10 minutes.
49 2021-02-26 flushing Throat tingling, flushed, diaphoresis, increased blood pressure to 160's,
49 2021-02-26 numbness Systemic: Numbness (specify: facial area, extremities)-Medium
49 2021-02-26 muscle spasms Mild fever, tiredness and loose bowel which cleared up after 12 hours. Vaccine also seemed to provok... Read more
Mild fever, tiredness and loose bowel which cleared up after 12 hours. Vaccine also seemed to provoke an MS-related response with pain in back, leg spasms and difficulty walking. Symptoms began to clear about 24 hours after onset (36 hours after vaccine injection). First vaccine was tolerated well with only mild and normal side effects (mild cough, soreness at injection site, etc.).
49 2021-02-26 pain in extremity Fever and body aches for one day the day after. Then 2/26 got large swollen area in underarm of arm... Read more
Fever and body aches for one day the day after. Then 2/26 got large swollen area in underarm of arm where got shot and it is extremely painful.
49 2021-02-26 tremor, feeling hot, seizure came to the vaccination appointment with no current illness or cough. Within less than 5 minutes af... Read more
came to the vaccination appointment with no current illness or cough. Within less than 5 minutes after the injection started with a cough that is similar to asthma attack onset. As talking with the nursing staff on site after waving them over I began to get worse very quickly. Within minutes I heard one of the staff say "she's crashing, move it". At that point I could not breathe, audible wheezing, shortness of breath, throat was closing, entire body felt like it was on fire, extreme itching on back (especially upper back), shaking/convulsing, incoherent. Paramedic staff was put into place and i was ambulanced to the hospital across the street from the vaccination site. Everything is a whirlwind at this point and treatment from what I can remember was albuterol svn, atrovent svn, use of cpap, epipen administration in the parking lot, benadryl via iv, solumedril, oxygen and pepcid. Once arrived at E.R. I was aggressively treated. Once stabalized began to wheen off the oxygen onto room air. I am a rare asthmatic and my oxygen sats usually do not drop, although I am in distress. At one point I heard oxygen sats were at 96, which is low for me. I was discharged from the hospital to my husband's care. In the next days now I am expriencing fever (100), itching, red rashy skin, severe headaches, joint pain, body ache, diarehha and extreme fatigue
49 2021-02-27 hot flush Fever 100, chills, hot flashes, nausea, splitting headache, low ringing in ears, upset stomach
49 2021-02-27 pain in extremity I received the first dose of my vaccine at 4:20 pm. My left arm was sore at the injection site prett... Read more
I received the first dose of my vaccine at 4:20 pm. My left arm was sore at the injection site pretty quickly as I would have expected. At about 9:30 pm, I noticed that both of my hands were painful and achy (I assumed the cause was flu-like symptoms from the vaccine). Upon examination of my hands, I noticed that my veins were significantly enlarged and bulging from partway down my forearms through my hands. When I raised my hands in the air, the veins became smaller and the pain subsided. I took 2 advil and went to bed with my hands slightly elevated. When I woke up in the morning, the veins were back to normal.
49 2021-02-27 pain in extremity Headache, eyes sensitive to the light, nausea, soar arm.
49 2021-02-28 weakness, tremor Painful site Weakness and shaking Tingling sensation in mouth EMS called and recommended transport t... Read more
Painful site Weakness and shaking Tingling sensation in mouth EMS called and recommended transport to the hospital - patient declined
49 2021-02-28 feeling of body temperature change The side effects after the first of the two vaccinations (01/23/21) resulted in the side effects sta... Read more
The side effects after the first of the two vaccinations (01/23/21) resulted in the side effects starting same night and resolving by 01/25/21 of headache, fatigue and localized soreness at vaccine injection site. The side effects from tge 2nd vaccination administered on 02/13/21 resulted in the side effects beginning later the same night of moderate site soreness, severe fatigue, headache, feeling hot and cold, loss of appetite and pain in muscles. All of the side effects resolved by 02/18/21 except the fever and chills which has happened every night since the second vaccination and had not been experienced prior to tge vaccination.
49 2021-02-28 migraine, pain in extremity dull achiness on the right side of temple area/headaches; head was sensitive; really bad migraine; t... Read more
dull achiness on the right side of temple area/headaches; head was sensitive; really bad migraine; turn off the lights in the office/has to have the lights low, still sensitive; arm hurt worse with second dose; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EK9231, expiry date Apr2021), via an unspecified route of administration on 19Jan2021 at a single dose, administered left arm at 4:10-4:15pm, as a coworker came down with Covid (COVID-19 immunization). The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm hurt with first dose of bnt162b2 given intramuscularly in the left arm (Lot number EL1284) on 29Dec2020 for COVID-19 immunization. Patient had her second Covid vaccine last Tuesday, 19Jan2021. She had a really bad migraine Friday, 22Jan2021 and had to turn off the lights in the office. On Saturday, 23Jan2021, her head was sensitive, but on Sunday, 24Jan2021, later in the evening she had this dull achiness on the right side of temple area that went down behind the right eye down to the temple. The dull and achiness was just enough to where she couldn't function and been like that ever since. She was prone to headaches and migraines, this was just different and so she took Tylenol and Aleve (both with believed dose was 200mg, 2 tablets by mouth since Jan2021), and another medication for migraines, Ubrelvy (lot number: 1084537, expiry Jan2022, dosage text: 100mg, 1 by mouth at first sign of headache, started in Jan2021). She took the Tylenol and it maybe of help, but the migraines/headaches are almost constant all day long. She took the Tylenol early Friday and when the migraine got really bad that was when she took the Ubrevly. She took the Aleve only yesterday, but she still has to have the lights low, still sensitive. Patient knew that the headaches are a sign of Covid, but when she had her first dose her arm hurt. This second arm hurt worse, arm hurt worse with second dose (Jan2021), and she did fine the first few days and Friday was when all of a sudden she had the migraine and had to turn off the lights in the office. She sits at a computer. The events did not require emergency room or physician office visits. Therapeutic measures were taken as a result of really bad migraine, "turn off the lights in the office/has to have the lights low, still sensitive", and "dull achiness on the right side of temple area/headaches". The patient had not recovered from really bad migraine, head was sensitive, and "dull achiness on the right side of temple area/headaches". The outcome of the events "turn off the lights in the office/has to have the lights low, still sensitive" and arm hurt worse with second dose was unknown.
49 2021-02-28 night sweats Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120... Read more
Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120's bpm), nausea, severe fatigue, severe soreness at injection site (but mild swelling, mild itching). Starting from 3:30 am on 02/21/21 until about 3 pm on 02/22/21. Milder headache and fatigue throughout rest of that week. Back to normal now.
49 2021-02-28 pain in extremity arm pain/soreness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old fe... Read more
arm pain/soreness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EK9231), intramuscular at the left upper arm on 05Jan2021 10:20 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 05Jan2021, the patient experienced arm pain/soreness she took some Tylenol, not that she needed too much. She recovered from the arm pain/soreness within a day or two days. It was not a big deal. The patient weight was 157-158lbs on an unspecified date. The outcome of the event was recovered on Jan2021. No follow-up attempts are possible. No further information is expected.
49 2021-02-28 pain in extremity 2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil... Read more
2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser; it feels warm at the injection site; arm was initially sore and that was all/a sharp pain in her arm/it was very sore/arm hurt; I didn't realize if a 'lesion' (not clear over the call) kind of formed overnight; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry Date: Unknown), via an unspecified route of administration in left arm on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. It was reported that patient had her 1st Pfizer vaccine dose on Monday, 25Jan2021, her arm was initially sore and that was all. Then sometime today (on 28Jan2021) she has developed 2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser. She was driving home from work and felt a sharp pain in her arm. She pulled her car over because it was "very sore". "she was glad that she was close to home when this happened. It was kind of freaked her out." Patient also stated that she got the vaccine on Monday and today (on 28Jan2021) she was driving home. She hadn't had any issues other than her arm hurt but it feels warm at the injection site and she just got in to her house, she wanted to stretch, she didn't realize if a 'lesion' (not clear over the call) kind of formed overnight in Jan2021, it hurts, her arm hurts." No lab work was done. No treatment was received for the events. The outcome of the events was unknown. Information on the batch/lot number has been requested.
49 2021-03-03 pain in extremity Patient was vaccinated by EMT. Provider was not present for time of vaccination. Immediately followi... Read more
Patient was vaccinated by EMT. Provider was not present for time of vaccination. Immediately following vaccination, patient complained of sharp, left sided arm pain. No other symptoms were reported by the patient. Patient reported that vaccinator had administered the dose too high on the arm and was concerned with long-term affects. Patient was examined by provider and found that injection site was highly-placed in on upper arm. Patient was able had intact FROM in both arms and shoulders. Patient was advised to follow up with PCP if nerve like pain persisted for more than 5 days and to follow up sooner with PCP if she developed difficulty moving her arm, shoulder or developed concerning symptoms.
49 2021-03-04 burning sensation, tingling, bell's palsy She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling ... Read more
She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling sensation on her upper back which went up to her neck and head/tingling in my neck, face, lips and eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EH9899, Expiration date: not provided), intramuscular on the left arm on 19Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-year-old for COVID-19 immunization. The patient was worried it might be bell's palsy (medically significant) on an unspecified date. she experienced side effects on 22Jan2021 after receiving the vaccine on 19Jan2021. She had a knot at the injection site of her left arm on the first day. After 3 days, she experienced a tingling sensation on her upper back which went up to her neck and head. It was not excruciating pain but had presence to be noticed. It had been there since that day and was not going away. She had been feeling it around her eyes and on her lips. She was worried it might be Bell's Palsy. She was asking for advice and if this had been reported. As soon as she get the second Covid Shot at the 19Jan it was about 2-3 days afterwards, it was on the Friday and it was about 2' O'clock, well she had the knot in my arm, her left arm where she received the IM (Intramuscular) vaccination (Covid Shot) and she had started having the symptoms of like burning and tingling in my neck and in my face and in my lips and in my eyes and that is not gone away and I still have that knot in my arm, I still have the burning and tingling. she had some blood work done like last Thursday to see if she had any kind of like rheumatoid problems to see arthritis or something but other than that no. Consumer stated, "Well I work in the doctor office and the Physician the one he told me to get the blood work and it goes to the doctor office because I work in one. For treatment consumer stated, she had only been taking an Advil and it did not seem to help her. The outcome of the events was not recovered. Comments/Narrative: Patient will follow up with Physician next week. She is currently on vacations.
49 2021-03-04 feeling hot Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observa... Read more
Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observation by field ops and received by nurse. Nurses alerted immediately and made available to patient. Patient stated she went to the restroom because she ?felt hot and I needed to cool off? but returned to be observed. Vitals taken @ 1:56 pm BP 177/96, Pulse 104, O2 Sat 95%, Temp 99.4 F. Red Rash noted on bilateral arms and chest. Nurses made available to patient. At 2:16 pm vitals reassessed with patient positioned on the floor. BP 144/90, Pulse 78, Temp 97.1, Respirations 20. At 2:19 patient continued to state she felt ?hot?, nauseous, dry mouth and some tightness in the chest. Nurse offered additional help to the patient by calling EMS, but patient refused. Nurses continued to monitor patient. Vitals reassessed with patient upright on chair @ 2:30 156/82, 97.4 Temp, 95% O2 Sat, Pulse 85, Respirations 18. At 2:38 patient stated she is starting to feel less hot and it is easier to breath. Patient requested to use the restroom to refresh herself. Patient accompanied by Nurse. At 2:48 patient states she is feeling better and only feels slightly nauseous. No reports of chest tightness. Rash on arms cleared. Rash on chest significantly improved. Patient refused to stay for additional observation. Patient educated to consult with health care provider prior to receiving second dose. Earlier, patient stated she has had instances where she had to take Benadryl when taking NSAIDS, and also carries EPI Pen. Patient also educated to call 911 if ?chest tightness,? respiratory issues occur. Patient accompanied out by brother-in-law.
49 2021-03-04 tingling After receiving the medication, the patient stated that she felt tingling in right arm. She states t... Read more
After receiving the medication, the patient stated that she felt tingling in right arm. She states that she had a headache. It subsided in 20 minutes. Blood Pressure was very high 5:13PM 175/102 P94 O2 100: 5:19 PM 183/109 P96 O2 100 5:23PM 173/101 P99 O2 100 5:53 PM 162/98 P92 O2 99
49 2021-03-05 pain in extremity Pain at injection site, soreness in right arm, Abdominal cramps and diarrhea lasting throughout the ... Read more
Pain at injection site, soreness in right arm, Abdominal cramps and diarrhea lasting throughout the night
49 2021-03-05 tingling Pins and needles tingling and feeling of weakness in right shoulder/arm area.
49 2021-03-05 tingling 24 hr post vaccine: fever, headache, chest pain 48 hr post vaccination: tingling sensation in arms a... Read more
24 hr post vaccine: fever, headache, chest pain 48 hr post vaccination: tingling sensation in arms and legs (bilateral), rash on chest, face, back
49 2021-03-06 migraine I received my shot at 1pm on Monday, March 1. Forty five minutes after the shot was administered, I ... Read more
I received my shot at 1pm on Monday, March 1. Forty five minutes after the shot was administered, I started to have a metallic taste in my mouth. Five minutes after that, my lips and tongue started to tingle. Five minutes after that my tongue started to go numb and then a few minutes after that my throat felt sore. Around 3pm, I took two Benadryl. By 5:30pm, my tongue was no longer numb, but my mouth didn't feel right all night. I don't know if this was related, but on Wednesday morning I woke with the start of a migraine. I took something right away and was able to avoid it. I have only had 4-5 migraines in my adult life. I started to feel like I was getting a cold by Friday, but I'm not sure if this is related either.
49 2021-03-07 weakness Began feeling dizzy 20 hours after receiving vaccine. This progressed to fever of 102.7, chills, we... Read more
Began feeling dizzy 20 hours after receiving vaccine. This progressed to fever of 102.7, chills, weakness, and fatigue within 2 hours. These symptoms lasted until 4am the following day, when I began feeling better; fever and other symptoms resolved by 8am on 2/26.
49 2021-03-07 bell's palsy I developed Bell's Palsy 13 days after injection.
49 2021-03-07 bell's palsy Bells Palsy
49 2021-03-07 migraine Migraine, body aches, fever, fatigue
49 2021-03-07 tingling, flushing, numbness facial hives, left arm numbness and tingling, facial flushing w/ parenthesis. Evaluated by EMS-Clea... Read more
facial hives, left arm numbness and tingling, facial flushing w/ parenthesis. Evaluated by EMS-Cleared
49 2021-03-08 pain in extremity Joint pain in both shoulders, elbows, wrists, fingers, knees, ankles, and feet, as well as muscle so... Read more
Joint pain in both shoulders, elbows, wrists, fingers, knees, ankles, and feet, as well as muscle soreness. Two days after the first shot on February 15th, the pain in my arms, joints and muscles, was awful. The pain lasted for two days. After yesterday's shot, the soreness and pain came on within 12 hours. So far, the pain is manageable.
49 2021-03-08 tingling, numbness hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; he... Read more
hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-03-09 pain in extremity Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropp... Read more
Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropped to 99.6 for a day. I had chills, joint achiness, fatigue, foggy headed feeling, a runny nose, sinus pressure, headache, chest tightness and pain, arm pain, stomach pain, lymph nodes in my left armpit are sore (after 10 days), and I now seem to have a worsened allergy to dairy and a new allergy to nuts - I get very phlegmy, cough, and have chest pain and tightness. These symptoms lasted for 5- 6 days and the allergies with their symptoms and sinus pain and sore lymph nodes have continued.
49 2021-03-09 tingling, numbness No current pregnancy. Hives, itching, shortness of breath, light headed, numbness/tingling in extrem... Read more
No current pregnancy. Hives, itching, shortness of breath, light headed, numbness/tingling in extremities, thick/numb feeling in tongue, coughing. taken to ED and given IV Benadryl and oral prednisone. Given prescription of for prednisone and Zyrtec for home use. At home, shortness of breath with coughing, lightheadedness, numbness/tingling in extremities, itching persisted for the next 5days. Took prednisone as prescribed for 3 days. Did not take allergy medication. Three days later on Thursday 2/22, I fell while going down stairs and suffered a badly sprained ankle. I feel the fall is a result of lingering symptoms of the vaccine.
49 2021-03-10 feeling cold, weakness I experienced an inability to get warm in the afternoon and extreme fatigue, then after going to be... Read more
I experienced an inability to get warm in the afternoon and extreme fatigue, then after going to bed, I woke up with my heart racing, intense headache, head spinning, weakness, and sweating.
49 2021-03-10 pain in extremity, tremor, throat numbness, hot flush 20 minutes after receiving the vaccine I got a hot flush and a numb throat. I felt dizzy and medical... Read more
20 minutes after receiving the vaccine I got a hot flush and a numb throat. I felt dizzy and medical staff gave me 25mg of Benadryl and apple juice. I waited another 15 minutes and I felt tingling in the tongue. Dr observed me Pulse and Bp were low to start and became elevated. I received another 25mg of Benadryl and I was observed for another 20 minutes. I woke up that evening feeling tired. I woke up in a few hours feeling like I was beaten up joint pain and muscle pain. Muscle tremors were worse than normal it was difficult to walk. Low grade fever and headache. This lingered for a few days. I developed mouth sores after days and still had a headache. Arm pain and aches and pains. Total time feeling poorly was 9 days. I visited an allergist on the advice of facility, allergist advised Zyrtec before next dose. Second dose caused similar symptoms with severe aches and pains. I had trouble getting up or moving. Tremors on the right side leg and arm were markedly worse than normal. Instability and fatigue lasted three weeks. Mood swings were unusual.
49 2021-03-10 pain in extremity sore arm for 1st 24 hours it subsided. then had a low grade 99.9-100.4 temperature and body aches fo... Read more
sore arm for 1st 24 hours it subsided. then had a low grade 99.9-100.4 temperature and body aches for next 48 hours.
49 2021-03-10 tremor I felt flushed but had taken double dose of Zyrtec. Second dose caused similar symptoms to first dos... Read more
I felt flushed but had taken double dose of Zyrtec. Second dose caused similar symptoms to first dose with more severe aches and pains. I had trouble getting up or moving. Tremors on the right side leg and arm were markedly worse than normal and I was unstable on my feet. Instability and fatigue lasted three weeks. Mood swings and brain fog were unusual and persisted for no reason for 2-3 weeks. For one day I had inflammation of glands on the right side of my throat. Phone contact with doctor to report that allergy did not occur.
49 2021-03-11 weakness Dizzy, weakness, rapid heartbeat, splitting headache, nausaus, all while still at the vaccine clinic... Read more
Dizzy, weakness, rapid heartbeat, splitting headache, nausaus, all while still at the vaccine clinic. I remained there for 90 minutes and the symptoms did not change. Still have splitting headache and some dizzyness here we are two days later . . .
49 2021-03-11 feeling cold, weakness About 2 minutes after receiving the injection - I went through 4 'waves' over the next 25 minutes - ... Read more
About 2 minutes after receiving the injection - I went through 4 'waves' over the next 25 minutes - each wave lasted about 2 minutes. During that time - I felt a wave/rush of lightheaded/disorientation feeling/ a cold sensation was rushing throughout my body internally/weak-shaky/ dry mouth/ and one of the waves I felt like I had to make myself swallow/like a rush of adrenaline. These subsided - and started again with a couple minutes between each wave. I took a Benadryl once I arrived home - only 2 very minor waves that morning. No other treatment but now afraid and need guidance if I should get the 2nd injection in case the 2nd reaction is worse.
49 2021-03-11 flushing Patient became flushed, chest discomfort, hypertensive
49 2021-03-11 flushing Flushing (Chest and face) - gave 25mg PO diphenhydramine and sent her to the Emergency room for furt... Read more
Flushing (Chest and face) - gave 25mg PO diphenhydramine and sent her to the Emergency room for further care.
49 2021-03-11 numbness Chest pain with left arm numbness for 10 min duration. BP 110/80, HR 63, O2 99% RA. ASA 325 given an... Read more
Chest pain with left arm numbness for 10 min duration. BP 110/80, HR 63, O2 99% RA. ASA 325 given and 911 called
49 2021-03-11 tingling, numbness Patient stated that starting 1 week post vaccine, she experienced numbness & tingling starting at in... Read more
Patient stated that starting 1 week post vaccine, she experienced numbness & tingling starting at injection site, and went down to thumb.
49 2021-03-12 cold sweat 02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the... Read more
02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the restroom and almost fainted (lightheaded, nausea, black vision, cold sweat). Blood pressure was 84 over 44. In the afternoon had muscular pain and a low grade fever of 100F for about 2 hours. A little sore at the injection site but all symptoms disappeared on day two 03/13/2021
49 2021-03-12 pain in extremity, hot flush At around 1:30 I started feeling achy and tired. Overnight and the following day, I couldn't get out... Read more
At around 1:30 I started feeling achy and tired. Overnight and the following day, I couldn't get out of bed. I had an increase in hot flashes, which lasted through the 2nd day and I was back at work. On the 2nd day, the arm pain and swelling worsened. I had a 2 in x 2 in area of redness by the injection site. With the 1st one I had a lot of hot flashes, but nothing to where I was unable to work.
49 2021-03-12 pain in extremity, tingling, feeling hot Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blist... Read more
Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blisters, then developed. inflammation, heat, and pain also present. became difficult and painful to wear socks. shoes were also uncomfortable. swelling and sensitivity were present all day, but flare ups occured in evening which included further swelling, pain, redness, and tingling sensation. PCP diagnosed anti-fungal and said would improve. after 7 days on anti-fungal ointment, no improvement. Referred to dermatologist. Dermatologist diagnosed Pernio/Chilblain, likely related to 2nd Vaccine. prescribed topical steriod and suggested keeping toes and feet warm at all times.
49 2021-03-12 tingling 5:05pm chest pain, itching, paresthesia, sweating. gave patient 50mg benadryl. chest pain resolved... Read more
5:05pm chest pain, itching, paresthesia, sweating. gave patient 50mg benadryl. chest pain resolved and itching and paresthesia decreased. bp = 124/64. patient reports resolution of symptoms. Monistored until 5:30pm and allowed to leave.
49 2021-03-13 numbness Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium
49 2021-03-14 weakness, discomfort, pain in extremity Pain & stiffness: injection site within an hour of dose 3/12. The next morning, (3/13) 9:30 am, I w... Read more
Pain & stiffness: injection site within an hour of dose 3/12. The next morning, (3/13) 9:30 am, I woke with severe pain all over my body. The worst pain was left arm, neck, back, buttocks, calves. Moderate pain throughout the rest of my body, notably my torso and my jaw. I had terrible headaches throughout the day. I was fatigued/exhausted and slept for several hours intermittently throughout the day. By 9PM I started to feel less fatigued, but the pain was very bad in most of my muscles. I felt like my muscles were battered and beaten, bruised and weak. The next day (3/14) I started to have energy, but not a lot, around 11am, and was still very sore, but the pain had subsided, and no more headaches. Today is 3/15, I am still very tired, but wouldn't call it fatigue, rather less energy than I am used to. I have noticed that my back is still very sore, especially the intercostal muscles. My legs and buttocks are still very sore today. I would not call it pain, but definitely notable and uncomfortable soreness.
49 2021-03-14 electric shock sensation All symptoms on the side effect list... 101.4 fever, pain, chills, headache, joint pain, muscle pain... Read more
All symptoms on the side effect list... 101.4 fever, pain, chills, headache, joint pain, muscle pain, brain buzz.
49 2021-03-15 facial paralysis Fever, left side face swelling and drooping
49 2021-03-15 numbness PT c/o numbness to bilateral arms and face
49 2021-03-15 tingling numbness and tingling in both hands, pain in muscle at injection site, worse at night, unable to sle... Read more
numbness and tingling in both hands, pain in muscle at injection site, worse at night, unable to sleep
49 2021-03-16 weakness hair loss/eyebrows, cervical lymph node swelling, general itching, weakness Narrative: Vaccinated 3/... Read more
hair loss/eyebrows, cervical lymph node swelling, general itching, weakness Narrative: Vaccinated 3/4/2021, onset of hair loss 3/13/2021, lymph nodes 3/9/2021
49 2021-03-16 flushing Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All E... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All Expand All by Default COVID VACCINE CLINIC 3/16/2021 Patient: DOB: Date: 3/16/2021 MRN: Subjective Patient is a 49 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. She had stayed her 15 minute waiting period after the injection and asked to stay another 5 minutes. She felt fine until she reached the front doors, she started to feel short of breath, nausea, flushed. She denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, increased swelling, rapid progression of symptoms and respiratory distress. Past Medical History: Diagnosis Date ? Asthma ? Concussion without loss of consciousness 8/27/2019 ? Depressive disorder ? Esophagitis, reflux ? Hepatic steatosis 12/7/2018 ? HX OTHER MEDICAL ? Hyperlipidemia, mixed ? Hypothyroidism (acquired) ? Insomnia, unspecified type ? OSA on CPAP ? Pulmonary hypertension (HCC) Noted on CT, echo was normal. ? Pulmonary nodules 3/28/2015 Follow up with Pulmonary in 3 months for a CT scan ALLERGY REVIEW OF SYSTEMS: Patient complains of malaise/fatigue and shortness of breath Patient denies chills, fever, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches +lightheaded: SOB resolved by time arrival to ED medical bay. Previous Reactions: none Objective Vitals Vitals: 03/16/21 1158 03/16/21 1207 BP: 117/83 (!) 141/91 Pulse: (!) 103 86 Resp: 18 18 SpO2: 96% 97% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is morbidly obese. She is diaphoretic. Comments: Flushed HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Improved in observation bay. Monitored for approx 15 minutes. Pt ambulated but developed chest tightness. Albuterol inhaler provided (2 puffs) via inhalation. Pt reports immediate improvement of symptoms. She was able to ambulate w/o difficulty afterwards. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) VS stable. Resolution of diaphoresis and flushed appearance. Pt symptoms resolved with use of albuterol. Suspect exercise induced asthma. Recommend that she use albuterol if needed for wheezing or 30 minutes prior to exercise. Follow up with her pcp otherwise as needed. Pt voiced appreciation of her care today. APRN Electronically Signed 3/16/2021 11:52 AM
49 2021-03-16 muscle spasms I started having cramping on the 11th, and then that got better. On the 14th, I started having blood... Read more
I started having cramping on the 11th, and then that got better. On the 14th, I started having bloody stools. I ended up in the hospital starting on 15th - 18th. GI Bleed - It was a lower one. Treatments - Put me on antibiotics and I had to get two or three units of blood. Had a follow up with doctor - roughly, Feb 5.
49 2021-03-16 pain in extremity Headache nausea sore arm lethargic
49 2021-03-16 tingling Within 10 minutes got blurred vision and felt like going to faint. happened 3 times during first ... Read more
Within 10 minutes got blurred vision and felt like going to faint. happened 3 times during first 30 minutes happened 3 times. Felt like throat was tight when swallowing . Face started to tingle and numbness lips and tongue for about 5 minutes , Tightness in throat for 2 hours . went back to Cvs and stayed for a an hour . Felt like swelling of throat for the first night . 2 days had a sore throat , little by little went away. took 3 days to swallow normal. Called her doctor for advice on second short
49 2021-03-17 inability to speak, weakness, tingling Difficulty breathing, weakness, dizziness, couldn?t stand on my own, tingling of my hands and feet, ... Read more
Difficulty breathing, weakness, dizziness, couldn?t stand on my own, tingling of my hands and feet, inability to speak, tiredness and feeling unwell
49 2021-03-17 feeling hot, cold sweat Member observed to be lethargic. Member stated just feels hot, clamy and feels overheated. Not obs... Read more
Member observed to be lethargic. Member stated just feels hot, clamy and feels overheated. Not observed to be diaphoretic. Member also reports feeling dizzy. symptoms lasted approximately 10 mins. 911 called , triage completed and member declined to be transported to emergency room
49 2021-03-17 pain in extremity Developed a splitting headache, back of head, right side, minutes after vaccination. Also, arm was v... Read more
Developed a splitting headache, back of head, right side, minutes after vaccination. Also, arm was very sore 1 hour later, sore spot was over 3" wide at largest point, resolved overnight
49 2021-03-18 burning sensation, tingling Progress Notes Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID... Read more
Progress Notes Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC Date: 3/17/2021 Subjective Patient is a 49 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience tingling sensation along recent surgical incision and along both sides (had full knee replacement on March 9th). She also has "burning" going down the left leg from her knee down to foot. She denied all other symptoms. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , increased swelling, rapid progression of symptoms, respiratory distress and skin changes. Of note, she had not taken her medications this morning, which includes lisinopril. She had physical therapy this morning as well. She states that they iced her knee at the end of her session. ALLERGY REVIEW OF SYSTEMS: All other systems negative Left knee bandaged, wrapped with ace bandage. She also has compression socks on.: Tingling sensation along surgical incision on left knee and down both sides of same incision. Burning pain down left leg from knee to foot.: Previous Reactions: None to first covid vaccine. Objective Vitals Vitals: 03/17/21 1113 03/17/21 1129 BP: (!) 129/90 126/70 Pulse: 81 72 SpO2: 97% 100% Physical Exam Vitals reviewed. Constitutional: Appearance: She is obese. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Head: Normocephalic. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: Cervical back: Normal range of motion. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Symptoms likely related to ice therapy done at physical therapy prior to coming into vaccine clinic. Symptoms were resolving, back to her baseline when she left. Encouraged to notify surgeon or primary care provider if symptoms return or become worrisome. Electronically Signed 3/17/2021 11:30 AM
49 2021-03-19 hot flush, tingling Immediately after vaccine, felt tingly through arm and down leg (L side both). A few minutes later, ... Read more
Immediately after vaccine, felt tingly through arm and down leg (L side both). A few minutes later, she got hot on l side of face, like a hot flash.
49 2021-03-20 weakness Fever, aches, joint pain, headache, weakness, nausea, aftertaste, indigestion
49 2021-03-20 burning sensation I received my first Pfizer shot on March 3rd. No reactions at all. About 13 days later on Tuesday, M... Read more
I received my first Pfizer shot on March 3rd. No reactions at all. About 13 days later on Tuesday, March 15th, I noticed a small rash on my right side upper eye lid and the side of my eye but thought it may just be an allergic reaction to something. No pain or itching. I had a couple of similar spots on my scalp but didn?t think much of it. On Thursday, I had a headache but I do get headaches now and then. When I woke up on Friday morning, March 19th, I found my eye lid completely swollen and saw the rash had turned to blisters, and there was a new one by the inner corner of my eye and a very faint rash on my forehead. Still no fever, pain or fatigue but had a lingering headache and a burning sensation on the rash. Saw my opthalmologist right away who diagnosed it as shingles and did a complete eye exam. Luckily no shingles in the eye as that can lead to glaucoma or even blindness in severe cases. I was prescribed Valtrex (1000 mg x 7 days) and prednisone (60 mg x 5 days) by my PCP. Hoping that I was still in the 72 hour window when the antiviral med is effective, I started on the meds immediately. Today is the third day of treatment and the blisters seem to be crusting away and healing faster. Luckily, no new blisters as of now. The prednisone caused my eye area to swell up further so I am gradually tapering off the dosage from 60 mg prescribed to 40-30-20 mg. Keeping a watch for any complications such as ear pain or numbness in the face. Have a follow up appointment with ophthalmologist who will be dilating my eyes for further checks. I was glad to have found the Reddit board and see that there are over 50 cases of people reporting shingles after the first or second covid vaccine. I plan to delay or skip my second Pfizer vaccine for now.
49 2021-03-20 numbness 03:40 pm..Numbness in right cheek into lower jaw. similar to when you are coming out of novicane fr... Read more
03:40 pm..Numbness in right cheek into lower jaw. similar to when you are coming out of novicane from dental appt. Lasted about 15 minutes but subtle feeling for 24 hours. Friday morning: reaction to my BP meds of heavy head, weak hands that other meds caused me in past. Never had previously. Been on this med brand for over 3 years. The symptoms passed after 5 hours when med wore off. My BP seems lower than before shot. So reduced med to half dose 2x day and full dose once a day. Seems to have helped reduce symptoms, but they reappear less intense now. Also have heartburn and much more gas than ever had in past.
49 2021-03-20 pain in extremity The vaccinated arm was sore for about 24 hours. Dose 1.
49 2021-03-20 tingling, pain in extremity pt c/o of left arm pain after vaccination of the vaccine. and tingling of the left fingers. sympto... Read more
pt c/o of left arm pain after vaccination of the vaccine. and tingling of the left fingers. symptoms was resolved and patient went home
49 2021-03-21 flushing she experienced throat swelling, difficulty breathing, itching, flushing. she self-administered Epi... Read more
she experienced throat swelling, difficulty breathing, itching, flushing. she self-administered Epi-Pen which she brought with her. EMS was called.
49 2021-03-21 pain in extremity I had soreness on my shoulder that progressively extended to all of my upper arm and became more pai... Read more
I had soreness on my shoulder that progressively extended to all of my upper arm and became more painful. I had difficulty raising my arm or moving it (it reminded me of the pain I felt when I had a case of bursitis on my other shoulder years prior). When lying down I could not sleep on that side and had difficulty sleeping on my right side as I could not find a comfortable position for my left arm that would not cause shooting pain. This lasted for 2-3 days. It subsided after 5 days. However, 10 days later, sometimes I get a softer pain on that arm when I move it. I did take extra strenght Tylenol, as recommended by the person that provided the shot. It did not help a lot, to be honest.
49 2021-03-22 cold sweat Woke at 6am feeling dizzy. By 7:30, I was vomiting, lose stool and cold sweats. Lasted until approxi... Read more
Woke at 6am feeling dizzy. By 7:30, I was vomiting, lose stool and cold sweats. Lasted until approximately 1:00pm. Still feeling lethargic and have slight headache
49 2021-03-22 pain in extremity 3/22 very severe tightening of neck muscles and neck ache 3/23 woke up w very tight neck and head p... Read more
3/22 very severe tightening of neck muscles and neck ache 3/23 woke up w very tight neck and head pain. As the day progressed, experienced pain/inflammation in leg muscles and body. Headache worse. Brain fog. Slow to focus eyes.
49 2021-03-22 tingling Approximately 8 minutes after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, the ... Read more
Approximately 8 minutes after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, the patient reported feeling ?funny?. She described symptoms including itching/tingling, sweating and increased heart rate. She was immediately ushered into the counseling room of the pharmacy and a blood pressure monitor was attached to her arm. At 2:09 p.m. her blood pressure was 166/78 and heart rate was 98 BPM. At this time 25mg of diphenhydramine was given to the patient orally. In addition to the subjective symptoms, the patient?s complexion had turned from neutral to red, and her face was covered in what appeared to be hives. EMS was called, and while on the phone with a dispatcher, a subsequent reading found the patient to have a BP of 140/122 and HR 121 BPM (2:15p.m.). As instructed by the EMS dispatcher, 0.3mg was administered to the patient via auto-injector into the left thigh. Paramedics arrived several minutes later and the patient was helped onto a stretched and subsequently escorted from the building for further observation and treatment.
49 2021-03-23 numbness Patient presents to ED w/ chief complaint of numbness. Symptoms started as back pain with numbness... Read more
Patient presents to ED w/ chief complaint of numbness. Symptoms started as back pain with numbness to R middle finger. Symptoms progressed to Numbness of bilateral legs and face. +fatigue, exhaustion, weakness in fingers, mild SOB.
49 2021-03-24 feeling hot she experienced tachycardia (157 BPM); warm sensation in her chest and ears; This is a spontaneous r... Read more
she experienced tachycardia (157 BPM); warm sensation in her chest and ears; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown), via an unspecified route of administration on 08Mar2021 at age of 49 years old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first Pfizer Covid vaccine on 08Mar2021. Within 15 minutes she experienced tachycardia (157 BPM) and a warm sensation in her chest and ears. The symptoms resolved in 45 minutes. She would like guidance on if she should receive the second dose. The outcome of events was recovered on 08Mar2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tachycardia due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-03-24 pain in extremity Began feeling as if someone had punched me in the upper arm terribly around 11:30pm. Hurt arm to lif... Read more
Began feeling as if someone had punched me in the upper arm terribly around 11:30pm. Hurt arm to lift it. NO redness, NO swelling, just intense muscle pain. Had pain following day, so took Advil to help alleviate tense feeling in muscle. Also rubbed painful area to try to "work out" the stiffness. It seemed to help somewhat. Now around 35 hours later, the muscle is still feeling a bit "stiff", but much better. I'm sure I'll be back to normal two days after my vaccine.
49 2021-03-24 tremor, flushing flushing, mouth/lips trembling, and felt a little woozy. Lasted maybe 5-10 minutes, then wooziness w... Read more
flushing, mouth/lips trembling, and felt a little woozy. Lasted maybe 5-10 minutes, then wooziness went away and the trembling/chattering turned into tingling lips. Hours later, my lips still feel weird. Treatment is nothing - it's not a big deal, I just wanted to report this to be helpful. I will call my doctor if this doesn't go away in a few days.
49 2021-03-25 difficulty speaking Patient reports throat swelling and lips slightly swollen. 10 minutes later patient feeling like thi... Read more
Patient reports throat swelling and lips slightly swollen. 10 minutes later patient feeling like things are worsening. Epinephrine 0.3mg given x 1. VSS. Symptoms improved and patient discharged feeling normal. Left with hoarse voice and HA.
49 2021-03-25 flushing, hot flush I received the vaccine at 9:15a and was told to wait 30 min instead of 15 due to my anaphylactic all... Read more
I received the vaccine at 9:15a and was told to wait 30 min instead of 15 due to my anaphylactic allergy history. At 9:21a, while in the waiting area, I felt a flushing sensation through my body and felt my face grow hot. I got very light-headed even though I was sitting down and thought I was going to be sick, and my heart rate as noted on my watch became elevated. It went from low 70's to high 90's. My throat did not close up and I did take my regular allergy medicine and inhalers prior to the vaccine. After 30 minutes, I went to the facility restroom and noted my face was still red. I called my sister (a hospital doctor) who told me to immediately take Benedryl. After taking Benedryl, I was feeling better after about another hour and the nausea and light-headedness subsided. In total, the symptoms lasted about an hour and 45 minutes. I did not notify staff at Med.Centerl at that time as my throat didn't close but did contact my PCP and now have an appointment scheduled with an allergist at Med. Center for next week and have put my 2nd vaccine on hold until I see the allergist.
49 2021-03-25 numbness On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth ... Read more
On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth on side of neck, the cheek on the left side of my face was numb, my lips tingled, and my heart rate increased to 105 bpm. The facial numbness went away after a few hours and felt like I had received Novicane for dental work. The burning knuckles took 8 days to go away. I called my doctor's office and spoke to the on call nurse who said the reaction was likely due to the vaccine.
49 2021-03-26 weakness, hot flush I have felt extremely weak and fatigued since i got my First dose. It has not subsided at all and it... Read more
I have felt extremely weak and fatigued since i got my First dose. It has not subsided at all and it's been 8 days. I feel shaky and get hot flushing every time I exert myself. I feel like I have the flu.
49 2021-03-26 weakness Arm pain I pain around midnight the night of injection continuing through next day. Night sweats ... Read more
Arm pain I pain around midnight the night of injection continuing through next day. Night sweats Fever and chills March 27th all day StIff and painful joints and muscles everywhere Slight headache Energy drain was almost immediate and ongoing.
49 2021-03-26 pain in extremity Fatigue, sore arm, achy, chills,
49 2021-03-26 pain in extremity headache (not migraine) and ear ringing began about 20 hours after my second shot, had extreme arm p... Read more
headache (not migraine) and ear ringing began about 20 hours after my second shot, had extreme arm pain as well with both shots. The ear ringing is constant and loud and hasn't stopped since the day after shot 2. The headache seems to come and go.
49 2021-03-27 weakness Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, ... Read more
Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, severe muscle pain, and large swollen lymph node (size of golf ball under left arm/near injection site) 12 hours after second shot. Adverse events diminished 12 to 48 hours later.
49 2021-03-27 burning sensation I had a high level of normal body aches, but I am filling out this form because I had a high level o... Read more
I had a high level of normal body aches, but I am filling out this form because I had a high level of pain at past surgical incision sites. One at a hysterectomy incision from 19 years ago, at three of the nine incisions from a heller myotomy in Dec. 2019, and one internal at the point of what I assume must be esophageal scar tissue from the Heller myotomy. The internal pain was at the vert same point of pain post surgery. The pain presented as "burning" and aching that lasted approximately 12 hours. This morning, the pain is completely gone. The nurse I spoke with said that I should contact my physician within 24 hours, but that it did not sound like an emergency. Neither the nurse nor I could locate information about surgical site pain as a side effect of the civic 19 vaccination, so it was disconcerting. I am submitting this as it might be helpful to others who experience this to know that others have as well.
49 2021-03-27 tingling Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, she... Read more
Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: stiffness to left arm/hand/back of neck, dizzy, tingling to left arm. Assessment : Time of assessment 1551. Alert and oriented Actions taken: EMS on site, patient taken to triage area. 1455:BP 146/83, P 92, 98% O2 saturation; 1500: tingling gone to left arm, stiffness still present; 1502: 141/75, P 88. Reports feeling better, stiffness still present. 1508-EMS recommends home and to call 911 if symptoms get worse. Medications administered: No medication administered. Disposition:Home, instructed to call 911 if symptoms worsen, follow up with PCP. Ambulatory out with husband.
49 2021-03-28 pain in extremity Numbness of insertion site, sore and pain at the upper arm. Tiredness and sleepiness. Slept the enti... Read more
Numbness of insertion site, sore and pain at the upper arm. Tiredness and sleepiness. Slept the entire day/night of 3/25/21 & half day of 3/26/21.
49 2021-03-28 tingling Tingling in left hand approx 8 hours after injection
49 2021-03-29 weakness, tension headache At 10 minutes, tongue irritation. At 25 minutes, hives on palm of hand which resolved after 10 minut... Read more
At 10 minutes, tongue irritation. At 25 minutes, hives on palm of hand which resolved after 10 minutes. At 90 minutes, drop in blood pressure, dizziness, weakness, severe stomach cramps, nausea, vomiting, diarrhea, tightness in chest and head. Took Benadryl, Albuterol and Pepcid. One hour later, 103 fever, severe pain in all joints. Stayed on Benadryl for 24 hours. Once Benadryl was stopped, developed hives all over chest, various spots on arms and stomach, continued dizziness, swollen lymph node in arm pit. Eyes were swollen and itchy. and red. Resumed Benadryl x5 days, every time Benadryl stopped, hives resumed. . Periodic hives still surface as of this date but mostly improved. My MD suggested I report event.
49 2021-03-29 weakness Patient in waiting area post vaccination reports dizziness, generalized weakness, delayed speech, an... Read more
Patient in waiting area post vaccination reports dizziness, generalized weakness, delayed speech, and left leg weakness. Helped to laying position. Blood pressure of 158/110 noted. Patient oriented and able to follow commands. Provider notified. Transported to ER.
49 2021-03-29 burning sensation The night taking the shot, I noticed what look like chicken pox marks on the inside of my left and r... Read more
The night taking the shot, I noticed what look like chicken pox marks on the inside of my left and right arm. The next day those hives and more spreaded down both inside my forearms. From there everyday more would appear. My torso, under my breast, through out my back, neck and bum. Itch profusely and burning sensation. I called my doctor, she prescribed Hydroxyzine. It help at night but caused drowsiness. Stop taking 3 times a day prescribe, I slept through them. She suggest taking Zyrtec to help during the day. To date the itching is not as severe, I'm bearing it. Yesterday was the first day back to work. I did flare up
49 2021-03-29 facial pain, pain in extremity, nerve pain On day 2 after the vaccine I started to have very bad neck pain and headaches. The pain would move ... Read more
On day 2 after the vaccine I started to have very bad neck pain and headaches. The pain would move around my head, neck and spine with different intensities. It is now 5 days after the vaccine and since day 2 the pain has increased and I am also having nerve pain come and go in my face, hands and feet.
49 2021-03-29 feeling hot, flushing 1204 pm given 1st dose of Pfizer vaccine. at 1220 pt began to complain of nausea, headache, feeli... Read more
1204 pm given 1st dose of Pfizer vaccine. at 1220 pt began to complain of nausea, headache, feeling hot, flushed, & some dizziness. Bp 150/84 , pulse 104, pulse ox 98% on RA; denies shortness of breath. Pt offered some water. At 1225 pm began having tingling lips & throat feeling funny; no lip swelling noted; pt offered EPI and declined; she was offered & took po Benadryl 25 mg. 1227 vitals bp 142/90 pulse ox 95% p 104. At 1229 pt began to state her throat beginning to tighten and EPI pen 0.3mg administered in L thigh by a different RN assisting writer. Stat call made at 1229 also. 1231 Oxygen given 2L per NC as pt stated difficulty breathing. 1232 pt stated she starting to feel better but more nervous now than anything. 1233 pt able to stand & and escorted to the ED with stat team staff.
49 2021-03-29 muscle twitching Extreme fatigue; nausea; muscles aching; muscle twitching; sweating; This is a spontaneous report fr... Read more
Extreme fatigue; nausea; muscles aching; muscle twitching; sweating; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Mar2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included myasthenia gravis, undiagnosed autoimmune disorder, non-alcoholic fatty liver disease, hypertensive heart disease and allergy to mushrooms. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 12:45, the patient experienced extreme fatigue, nausea, muscles aching, muscle twitching and sweating. No treatment was given for the events. The outcome of the events extreme fatigue, nausea, muscles aching, muscle twitching, and sweating were not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
49 2021-03-29 tingling At 1625 patient started feeling lightheaded and had a metallic taste in mouth and had some tingling... Read more
At 1625 patient started feeling lightheaded and had a metallic taste in mouth and had some tingling in her right knee. Had patient lay in recliner and gave apple juice, she felt much better after 5 minutes and insisted on leaving.
49 2021-03-29 tingling 10 minutes after i received the injection to my right arm the right side of my neck felt tingly, 25 ... Read more
10 minutes after i received the injection to my right arm the right side of my neck felt tingly, 25 minutes after infection the feeling moved to my lips, 40 minutes after injection my whole face felt tingly, (like pins and needles or how your face feels after Novocain). I had no issues with my tongue throat of breathing.
49 2021-03-29 tingling 40 mins after inoculation, my left arm and hand felt tingly like my arm went to sleep. Lasted for ab... Read more
40 mins after inoculation, my left arm and hand felt tingly like my arm went to sleep. Lasted for about an hour. Left arm sore at the injection. 4 hours after inoculation, eyes were extremely heavy, felt tired and had a slight headache.
49 2021-03-30 breast pain May 26, 2021 afternoon started feeling a bit nauseous, sweats, upset stomach, similar flu symptoms ... Read more
May 26, 2021 afternoon started feeling a bit nauseous, sweats, upset stomach, similar flu symptoms as first days of Covid from last year. Later in evening around 7pm chills and aches (especially back got worse) By around 9:30pm I was fine. March 27, woke up in morning and was good March 28, right arm (injection site) was a little sore and noticed slight swelling and warm to the touch in that area. Also my underarm pit (injection arm) felt sore and swollen. Soreness extended to breast area (near underarm) March 30, underarm soreness almost all gone. Injection site soreness gone just still a bit warm to the touch
49 2021-03-30 flushing, feeling hot severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; hear... Read more
severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; heart pounding; funny feeling in throat; throat tightening; hacky cough; itchy throat; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: E19264) on 10Feb2021 08:00 AM at Right arm as single dose for covid- 19 immunisation. The patient medical history included Hypothyroidism and hypertension. The patient concomitant medication included Nifedipine, Levothyroxine, Vitamin D, started on unspecified date at an unknown dose and unknown if ongoing. The patient had allergies to bee stings and latex. On 10Feb2021, 09:00 AM, approximately 35-40 minutes after vaccine the patient experienced severe flushing and hot feeling, lightheaded, severe headache, heart pounding, funny feeling in throat. 1 hour after vaccine throat tightening, hacky cough, itchy throat. The patient was treated with allergy medication and famotidine. The outcome of the events was recovered. No follow up attempts are possible. No further information is expected.
49 2021-03-30 hot flush Increase in frequency but not severity/quality of hot flashes. Starting the day following the shot,... Read more
Increase in frequency but not severity/quality of hot flashes. Starting the day following the shot, and for about a week, I was having frequent (estimating 5 to 8) hot flashes each day. In the last couple of days it has declined to 2 or 3 per day. My typical frequency prior to the shot was about once every two days.
49 2021-03-30 numbness Initial transient nausea. In parking lot she had a headache and numbness in her ears. No s/s of an... Read more
Initial transient nausea. In parking lot she had a headache and numbness in her ears. No s/s of anaphylaxis or other more serious reaction.
49 2021-03-30 pain in extremity Pain in sacrum & hip flexors steadily increasing to entire pelvic girdle. Started at 10am and by 12p... Read more
Pain in sacrum & hip flexors steadily increasing to entire pelvic girdle. Started at 10am and by 12pm it was hard to sit to work. At 1pm I left work for the day (I work from home so simply let my supervisor know) because the pain was so intense I could not focus. The pain was constant & aching in the entire pelvic girdle with sharp random flashes - I would get one in my left hip flexor, then my sacrum, then down my right leg or in my right toes, then in my right TFL, then my left quad, etc. I could not find comfort standing, laying, sitting. I tried stretching, a heating pad, ice...nothing would help. It got steadily more painful to where I couldn't do anything but lay in bad trying to get comfortable from 3-6pm. My neck became tight as well as my rhomboids. When I would try to get up to walk, my sacrum hurt so much and everything was so stiff, it felt as if I had thrown out my back. I was on the border of being delirious from the ongoing & unrelenting pain. At 7pm I took 2 Advil and by 8:30pm it seemed like the edge was coming off a bit. By 10pm I was able to get comfortable enough to sleep. When I got up the next morning I thought I was better but after moving around a little the pain started to come back strongly in my lower back. I took 2 Advil again and that helped immensely. From then on I was SO much better with only occasional flashes of sharpness over the next two days (3/27 & 3/28). I am now totally fine. I have thrown out my back in the past, so I know what that is like and recognize the symptoms. This event was NOT due to anything like that. The pain set in slowly and steadily and the sharp flashes were not contained to a specific area as if I had an injury. They would happen in the most random spots and nothing was consistent about them (expect that they hurt a lot). Also, I would not have recovered so quickly if I had thrown out my back.
49 2021-03-30 tingling, numbness numbness and tingling on face
49 2021-03-31 cold sweat reported to onsite medical clinic at 11:30am after taking 2 puffs of albuterol, c/o HA/lightheaded/d... Read more
reported to onsite medical clinic at 11:30am after taking 2 puffs of albuterol, c/o HA/lightheaded/dizzy, VSS, developed mild SOB/clammy/groggy, sent to Emergency Room for evaluation and treatment where it was documented that she had an anaphylaxis reaction to the vaccine administered at 0800 on the same day at a community vaccination event
49 2021-03-31 migraine I got the second shot at 3 pm and by 2 am I had a temp of 100 and body aches and felt like I had the... Read more
I got the second shot at 3 pm and by 2 am I had a temp of 100 and body aches and felt like I had the flu. It is now 8 pm- 29 hours after the injection and I still have a fever and a migraine. Haven?t gotten out of bed
49 2021-03-31 pain in extremity pt states the same day she took the vax when she went to bed she had the chills. When she woke up s... Read more
pt states the same day she took the vax when she went to bed she had the chills. When she woke up she still had chills, had 100.1 fever and was very fatigued. Pt took Tylenol and Emergent C packet and a throat lozenges. She had a sore right arm that was red and warm. She used cold compresses on it which helped. Pt says her symptoms were gone by the first day. On 3/31/20221 pt had a herpes simplex type rash develop all over her body and on this inside of her palms. Pt started using Acyclovir medicine to treat this. Pt still has these symptoms.
49 2021-03-31 tingling, numbness Numbness, tingling right side of face. Evaluated by EMS-Cleared
49 2021-03-31 tingling 30 minutes post vaccination, numbness on entire right side of face. Resolved after about 3 hours, bu... Read more
30 minutes post vaccination, numbness on entire right side of face. Resolved after about 3 hours, but all sensation has not returned.
49 2021-04-01 difficulty speaking, feeling hot Patient felt warm and lightheaded ~5 minutes after receiving her first covid19 vaccination. Started ... Read more
Patient felt warm and lightheaded ~5 minutes after receiving her first covid19 vaccination. Started to develop a sore throat, itching (no hives), hoarseness, and a headache within 15 minutes. Given Benadryl 50mg and observed. Hoarseness persisted through an hour of observation but itching and sore throat resolved. No difficulty breathing or shortness of breath. Given no worsening symptoms, patient felt comfortable going home with her daughter who was counseled on signs and symptoms to watch out for. Patient does have an epi pen available due to history of anaphylaxis in the past and is aware of signs/symptoms and when to seek medical attention.
49 2021-04-01 feeling hot Pt arrived to observation room in her own wheelchair with family members after receiving Covid vac... Read more
Pt arrived to observation room in her own wheelchair with family members after receiving Covid vaccination. At 25 minutes into 30 min observation she c/o feeling warm, itchy and headache. No rash noted, denied SOB/difficulty breathing. PT states was reluctant to receive vaccine but MD urged her to do so. Pt AO x 3 and verbalized consent for care.. PT given vaccine education. No redness or swelling noted at injection site. 0931 pt given 50mg diphenhydramine PO 0934 O2sat 99%, HR 61 0937 BP 122/68 0942 HR 60, O2sat 99%. encouraged pt to remain an additional 30 mins in observation but declined to stay but states "I think I will be fine."; pt and family educated on ED protocols. PT left in wheelchair with family member
49 2021-04-01 flushing, feeling hot Metallic taste in back of mouth Warm flushing sensation in chest Sensation of throat closing
49 2021-04-01 pain in extremity A little bit of pain at the arm and fatigue. Approximately one week later on 4/22, I noticed 2 pea-s... Read more
A little bit of pain at the arm and fatigue. Approximately one week later on 4/22, I noticed 2 pea-sized swollen supraclavicular lymph nodes and have extreme collar bone and a/c joint/shoulder pain. I read case studies about other vaccine recipients who had a lymphadenopathy in similar areas, so I will wait to see if it clears up before seeing a doctor.
49 2021-04-02 numbness, flushing Almost 1 hour exactly after the vaccination I felt numbness in my right cheek that lasted for maybe ... Read more
Almost 1 hour exactly after the vaccination I felt numbness in my right cheek that lasted for maybe 30-60 seconds. About 2 minutes later I felt a flush and odd overall/dizzy feeling with some trouble swallowing. This lasted about 40-60 seconds. Over the next few hours I had additional brief episodes where my throat felt like it was closing up. All was well by about 3 hours after, and today (the day after the vaccination)I have had no additional numbness or dizziness/trouble swallowing type symptoms. My only symptoms today are mild pain at the injection sight and slight tiredness.
49 2021-04-04 feeling hot Immediately after receiving the IM vaccine patient states she experienced shortness of breath but fe... Read more
Immediately after receiving the IM vaccine patient states she experienced shortness of breath but felt very warm all throughout her body. The symptoms lasted for a couple minutes and quickly resolved.
49 2021-04-04 migraine, pain in extremity Migraine, muscle soreness, joint pain, severe body aches on day 3 lasting less than 24 hours. Took... Read more
Migraine, muscle soreness, joint pain, severe body aches on day 3 lasting less than 24 hours. Took two Imitrex and 400mg Ibuprofen to reduce symptoms. Some residual minor shooting muscle leg pain on day 4 and 5
49 2021-04-04 pain in extremity chest pain, right leg pain
49 2021-04-04 tingling, burning sensation Severe rotator cuff / muscular pain in right shoulder (opposite arm from injection) Burning . Painfu... Read more
Severe rotator cuff / muscular pain in right shoulder (opposite arm from injection) Burning . Painful to the touch. Difficulty using right arm. Restricted motion.
49 2021-04-04 tingling Pt reported @ 1146 tingling in neck left side (injection side) VS: BP 78/palpated, HR 65, Osat 94%
49 2021-04-05 difficulty speaking At 24 hours, in a very short period of time, my temp went from normal to 104.9, I got chills; and m... Read more
At 24 hours, in a very short period of time, my temp went from normal to 104.9, I got chills; and my fingers, hands and lips turned blue. I went to urgent and they think because my fever went up so rapidly, my blood vessels constricted. I went home, alternated Tylenol and Ibuprofen during the night. On the morning of the 22nd, I woke up and my face was really swollen along with swelling under my armpit. I was also really hoarse. I went back to urgent care and they put me on a steroid, Benadryl and Pepcid. After that, everything slowly improved. It took a while for me to recover fully.
49 2021-04-05 feeling hot Patient was being monitored for additional time as she has allergies. About 7-10 minutes patient n... Read more
Patient was being monitored for additional time as she has allergies. About 7-10 minutes patient noted she was feeling "itchy". She was found to be scratching her throat, and arms. Patient was brought to the exam room, she stated she was feeling warm, itchy and a lump in her throat along with dryness. BP at that time was 157/111. Patient reported increasing feeling of a lump in her throat, at that time Epinephrine 0.3 mg injection was administered. Nurse called 911. Patients BP was then noted to be 157/89. Patient stated she was feeling warm, and itchy, felt like she had to cough due to the lump in her throat. About 10 minutes after the first epi injection, patient was feeling nauseous, hot and her throat was still dry with the lump. The second dose of epinephrine 0.3 mg was given. About 2 minutes after the second dose of epinephrine EMS was on scene and patient was transported to Hospital. Nurse called Dr to Update on the patient incident.
49 2021-04-05 flushing Pt is a 49 YO Female presented with severe anxiety upon initial contact with medical observation phy... Read more
Pt is a 49 YO Female presented with severe anxiety upon initial contact with medical observation physician. After some coaching and sitting with physician pt decided to get the vaccine and physician gave approval. Pt then proceeded to booth 9 and a paramedic gave pt her 1st does of the Pfizer vaccine. Pt was still very anxious but agreed to continue with the vaccine injection. After injection was given pt stayed in booth for an addition 10 minutes with the paramedic. Pt was coached to take slow deep breathes in order to get her breathing under control. After pt started to calm down, she was asked if she was ready to proceed to medical observation for her 30 preset time. Pt agreed and we walked to the observation tent. Pt was transferred to the observation unit team for the next 30 minutes. At approximately 1410, the paramedic was alerted that pt was having an adverse reaction and needed to be medically assessed. The paramedic immediately proceeded to patient with medical equipment given by facility. Upon assessment pt presented A&OX4, very anxious, skin flushed, complaining of dizzy, lightheaded, and a headache. Pt was speaking normally and vitals were assessed. Vitals are as follows: At 1418- BP 186/110, HR102, RR26, SPO2 99% Lung sounds clear in all fields, Skins: hot, flushed, moist; At 1427- BP 196/116, HR 99, RR 24, SPO2 98% Lung sounds clear in all fields, Skins hot, flushed, moist. PT was then assessed for possible stroke and was negative slurred speech, negative arm drift, pt had symmetrical smile, and equal grips bilaterally. The decision at that point was made by the paramedic to activate the EMS 911 system for further evaluation and possible ALS ambulance transport to the hospital for further evaluation by emergency physicians. After EMS arrived and assessed the patient, they agreed the patient should be transported to the ER and pt was transported to local hospital, Pt care was transferred to responding paramedics and pt contact ended at that point. Report was given to responding paramedics.
49 2021-04-05 pain in extremity Sore arm days 3&4. Sharp pain when lifting arm. Extreme fatigue, muscle and joint pain days 3-5.
49 2021-04-05 pain in extremity Arm started sore 4 hours after vaccine, next morning same, by 3 pm it was swollen, red, hot to touch... Read more
Arm started sore 4 hours after vaccine, next morning same, by 3 pm it was swollen, red, hot to touch, by 5:30 it was itching with bumps, neck pain, headache, fever of 101.
49 2021-04-06 bell's palsy face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowi... Read more
face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowing; difficulty breathing & swallowing; nausea; metallic taste in mouth; double vision; This is a spontaneous report from a contactable consumer. A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 18Mar2021 at 08:15 (Batch/Lot Number: EP7534) as a single dose at the age of 49, for Covid-19 immunisation. Medical history included juvenile- als, and a sulfa allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 18Mar2021, after use of product patient developed Acute pain in base/spine of neck, dizziness, difficulty breathing & swallowing, nausea, metallic taste in mouth, face felt like plastic, double vision. The patient was not hospitalized nor was treatment received for the events. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19. Additional Information has been requested.
49 2021-04-06 difficulty speaking 5 mins after injection pt felt shortness of breath, throat closing, hoarse voice, tongue swelling p... Read more
5 mins after injection pt felt shortness of breath, throat closing, hoarse voice, tongue swelling pt given 50mg benadyl as well as 0.3mg epi pen, with reduction of throat tightness however pt continued to have sensation and occasional throat clearing/cough
49 2021-04-06 feeling hot Shot received at 10:15 am 10:45 am palms get hot and itchy. 12:15 pm tongue feels heavy and swollen,... Read more
Shot received at 10:15 am 10:45 am palms get hot and itchy. 12:15 pm tongue feels heavy and swollen, , throat is itchy and a shallow, dry cough devlops, lips swell, itchy palms, rapid heartbeat. Gets better after 30 minutes 3:45 pm same reactions occur again. Resolve when I take 4 Benadryl. Next day, feel better but tongue tingly and slight cough with itchy throat, headache, and overall fatigue.
49 2021-04-06 feeling hot 4/3- 10:45 am Shot given. Immediate warm feeling in arm 11:00 am by the end of the waiting period... Read more
4/3- 10:45 am Shot given. Immediate warm feeling in arm 11:00 am by the end of the waiting period arm hurt, felt heavy and stiff 12:00 pm dull headache, loss of appetite 3:00 pm low grade temp: 99.1 body aches 6:00 pm temp: 100.2, husband noticed left arm was severely swollen, tight, and hot. No rash or change in color. 10:00 pm and Throughtout the night: Chills, sweats, severe body aches, severe headache (could barely lift my head off the pillow), elevating fever, left arm felt heavy, hot and swollen, 4/4-5:00 am temp: 102.9, took 600 mg ibuprofen Slept well 8:00 am: temp 100 No body aches, chills, sweats. All other symptoms continued About 1:30 pm temperature increased again. It topped out at 101.5 in the evening. Took 600 mg ibuprofen. Slept all night. 4/5- wake up temp: 99.1 continued headache, nausea, heavy feeling throughout body Temp throughout the day ranged from 99.1-99.7. Headache dissipated about mid-day. 4/6- temp 98.5 upon wake up. By mid-morning all symptoms had dissipated, but still linger in the background. More energy. 4/7- normal temperature. Increased energy, returned to work. Mid-day, mild tummy issues and lightheadedness returned.
49 2021-04-06 flushing approximately 8-10 minutes after first dose-experienced flushing through head, down throat some sens... Read more
approximately 8-10 minutes after first dose-experienced flushing through head, down throat some sensation in throat, had to take deep breath, went down arms, felt very heavy, improved after about 15 minutes then very mild recurrence about 35-40 minutes after dose Because of throat symptoms took benadryl and pepcid 30 minutes prior to 2nd vaccine. 1hr 40minutes after 2nd, difficulty swallowing water, flowing/flushing sensation then my lips were tingly and eyes itchy briefly. My HR was 90's which is high, my resting is 40's-50's. Arms would feel heavy with this. This happened later in the day again, Very unsettling, was in contact via text with cardiologist I work with ( I am an ARNP) and my Dr that is listed on this form. They told me I could keep taking Benadryl and Pepcid q 6-8hrs. I was also given prescription for prednisone if needed. Following day went about 8 hrs between doses, same symptoms took Prednisone that eve, I believe 10mg this was in addition to Benadryl and Pepcid. These episodes kept happening for about 5-6 days. On Friday, 3 days after 2nd dose, I tried to space out meds. then in afternoon about 4:40 was actually short of breath and felt tight with breathing. So took meds and actually considered using my son's old inhaler. Symptoms resided in about half hour after meds. Last dose of meds was Sunday 8 PM after 2nd vaccine. Ran in morning and HR would not come down, stayed in 110's very unusual for me, I felt SOB. Had EKG when I went to office but just prior to EKG symptoms resolved and I was SR in 70's Had BMP and Mg these were NL. I run daily and had noted increased SOB and HR after first vaccine this continued until just a few weeks ago. We feel this was some type of allergic reaction with possible mast cell activation. I had internal "tightness" no appetite and felt like constant state of adrenaline for about 1-2 weeks. Concerned if booster needed and for my son who is 18 that has some allergies
49 2021-04-06 muscle spasms Dizziness, nausea, foot cramps, 5 days later symptoms still persist.
49 2021-04-06 pain in extremity Swollen nodes under armpit and above clavicle. Feels hot and burning pain under armpit and arm.
49 2021-04-06 pain in extremity None at time of shot except tenderness in injection area and arm soreness. About 40 hours later, swe... Read more
None at time of shot except tenderness in injection area and arm soreness. About 40 hours later, swelling of face (lips) and hands, high histamine.
49 2021-04-06 pain in extremity immediately after injection: dizziness within 10 minutes of injection: mild headache 30 minutes afte... Read more
immediately after injection: dizziness within 10 minutes of injection: mild headache 30 minutes after injection: arm aching, mild nausea, shooting pains down arm, through elbow headache & nausea resolved within 6 hours; dizziness & arm aching still present after 6 hours.
49 2021-04-07 numbness Teammate complained of numbing of her face, Left Upper Quad. TM was given 50 mg of Benadryl. Her ... Read more
Teammate complained of numbing of her face, Left Upper Quad. TM was given 50 mg of Benadryl. Her husband drove her home. She was symptom free @04:00 Thursday April 8th.
49 2021-04-07 pain in extremity, numbness Pt reports experiencing soreness and numbess from back of shoulder radiating down to figertips. This... Read more
Pt reports experiencing soreness and numbess from back of shoulder radiating down to figertips. This started 9 days after vaccination, and has improved over time. Pt insists it is result of vaccine.
49 2021-04-08 weakness Patient received the first dose of the two part Pfizer COVID 19 vaccine series on 4/8/21 around 3PM.... Read more
Patient received the first dose of the two part Pfizer COVID 19 vaccine series on 4/8/21 around 3PM. Patient arrives to the Emergency room on the morning of 4/9/21 with a chief complaint of "heart racing". Patient reports her symptoms started around 7AM on 4/9/21. She reports that her heart feels like it starts beating really fast, and then will slow down, and then starts beating really fast again. She also reports that she feels short of breath and reports that she has difficulty finishing sentences due to this shortness of breath. Patient reports that she also has been having chest pain, but reports that she often has heart burn, so is unsure if this is related to that. Patient also reports that she feels generally weak and dizzy, with a headache. Patient reports all of these symptoms started around 7AM on 4/8/21. ** At time of submission of report, patient is still admitted to emergency department and patient's current medical status is to be determined**
49 2021-04-08 weakness Fever of 104 1 F, chills, muscle arches, weakness, tired, headache - started within 12 hours of vacc... Read more
Fever of 104 1 F, chills, muscle arches, weakness, tired, headache - started within 12 hours of vaccine injection; still experiencing as of 18 hours post injection.
49 2021-04-08 discomfort Intense heavy crushing feeling in entire body, as if gravity was suddenly ×10. Slight tightness in ... Read more
Intense heavy crushing feeling in entire body, as if gravity was suddenly ×10. Slight tightness in throat
49 2021-04-08 flushing Patient complaints of flushed feeling after 5 minutes with first Pfizer. VSS. Patient given Benadr... Read more
Patient complaints of flushed feeling after 5 minutes with first Pfizer. VSS. Patient given Benadryl 50 mg orally. Monitored for 30 minutes with no other issues.
49 2021-04-08 pain in extremity Patient reports burning in chest, arm pain, headache, chills that have lasted 3 days after vaccine. ... Read more
Patient reports burning in chest, arm pain, headache, chills that have lasted 3 days after vaccine. Also with diarrhea
49 2021-04-08 pain in extremity About two hours after my first vaccine, my arm was a little bit sore and I felt tired. The next morn... Read more
About two hours after my first vaccine, my arm was a little bit sore and I felt tired. The next morning I was fine. On day 11 around 6 PM I noticed suddenly that my left arm started becoming extremely sore again. Especially where I received the vaccine. A few minutes after that I started not feeling well and extremely lethargic. I stayed in bed all day the next day but luckily today I woke up and I?m OK again. Just wanted to let you guys know.
49 2021-04-08 tingling, burning sensation, numbness Developed strong / severe paresthesias - A feeling of tingling / numbess / burning or 'electricity' ... Read more
Developed strong / severe paresthesias - A feeling of tingling / numbess / burning or 'electricity' over whole body, sometimes mild, sometimes more severe, migrating from arms / hands to legs/feet - at night waking up with both arms numb and the numbness feeling extending into chest. Sometimes accompanied by brief, stabbing pains. Was most severe during the first 3 or so days, then seems to be slowly decreasing but gets worse at night. Has not completely resolved after 7 days. Also developed muscle stiffness / lower back pain around day 4 or so.
49 2021-04-08 tingling, numbness The patient started experiencing right arm tingling at her fingertips after she received her vaccina... Read more
The patient started experiencing right arm tingling at her fingertips after she received her vaccination. She had no other symptoms including no dyspnea, weakness, or symptoms in other parts of her body. After some time, she started having some numbness of the fingertips.
49 2021-04-08 unresponsive to stimuli Immunization clinic note: Patient reported feeling dizzy after about 20 minutes post-vaccination. Pa... Read more
Immunization clinic note: Patient reported feeling dizzy after about 20 minutes post-vaccination. Patient had a blood pressure of 140/100, had pulse and was breathing well. She was in and out of consciousness and non-responsive. EMT arrived about 10 minutes later and she was transported to ER. ED note: Pt observed while in the ED - ambulating about dept, maintains stable vitals, no recurrence of syncope. Remains symptoms free. Discussed with pt that syncope - likely vasovagal in light of covid vaccine administration. We discussed possibility of allergic reaction - at this time, no signs for airway compromise and pt remains comfortable on RA. We will dc home with rx for benadryl and 4 additional days of prednisone.
49 2021-04-09 feeling hot, cold sweat 8 Days after first injection almost fainted while driving. Heart raced and felt hot/clammy/dizzy/bl... Read more
8 Days after first injection almost fainted while driving. Heart raced and felt hot/clammy/dizzy/blurred vision. Lasted for 20 minutes. Continue to feel light headed, occasionally dizzy, and brain fog since then..
49 2021-04-09 numbness Swollen lips, swollen mouth, swollen tongue, swollen trachea, irritated gums, facial numbness
49 2021-04-09 numbness Left-sided facial numbness beginning with nose and progressing to cheek, lips and jaw. Symptoms bega... Read more
Left-sided facial numbness beginning with nose and progressing to cheek, lips and jaw. Symptoms began 30 min after vaccine administration and Benadryl 50 mg was taken at that time. Symptoms continued for four hours and improved within 12 hours of administration.
49 2021-04-09 migraine Migraine about 3 am which I medicated with Tylenol and Imitrex. Flu-like body aches from 10 am - pre... Read more
Migraine about 3 am which I medicated with Tylenol and Imitrex. Flu-like body aches from 10 am - present.
49 2021-04-09 pain in extremity, feeling hot, tingling I got my shot at 2:10 pm yesterday it just burned and itched a bit at first. Then later at 6 pm I g... Read more
I got my shot at 2:10 pm yesterday it just burned and itched a bit at first. Then later at 6 pm I got chilled, then super hot at 8 pm, then the itching and burning feeling came back and at 9pm began to spread across my shoulders and upper back with a prickly rash. At 10:30 pm the itching was also on my face and upper back. I took a Benadryl and a Tylenol at 10:10 pm. I'm feeling fine this morning with the exception of the sore shot arm.
49 2021-04-09 pain in extremity 1 day later, experienced soreness in left arm, 2 days later, experienced headache and stiffness of n... Read more
1 day later, experienced soreness in left arm, 2 days later, experienced headache and stiffness of neck and shoulders, and 3 days later awoke at 9am and soon after felt severe chest tightness and pain accompanied by shortess of breath, dizziness and nausea (feeling of vasovagal). After about 10 minutes, I chest tightness went away and I took myself to the ER, where they did blood tests, EKG, xray of lungs. Everything was normal.
49 2021-04-09 tingling, pain in extremity I got the 2nd dose about 2pm. I stayed for over the 15 min because I was talking with a friend and w... Read more
I got the 2nd dose about 2pm. I stayed for over the 15 min because I was talking with a friend and we were there closer to 20 min. I had a headache right after the shot was administered and my arm hurt. I was fine earlier that day. By about 2:25 I was heading home and wanted to get some McDonald?s because I had an hour drive. I noticed in the drive through that my eyes felt they were being sunken in. My right eye and side of nose started to tingle. It started spreading on my right side down to my lips and up to my scalp. Then down my arm to my fingers and down my right leg. I was dizzy and nauseous and confused. I managed to call my boss at triton who said to come back to the office. The nurse met me in the office where I had laid on the floor to try and help the pressure. By then I was numb on my whole face. Teeth and tongue but was able to swallow and talk. They called an ambulance to have me checked out. My blood pressure was high while there. They asked if I had been anxious or having a panic attack. I was neither. I just felt dizzy and numb.
49 2021-04-09 cold extremities, tingling, numbness From 1:30 am to 7:30 am 4/10/2021 Tachycardia Tightness in chest Possible Difficulty breathing ?? F... Read more
From 1:30 am to 7:30 am 4/10/2021 Tachycardia Tightness in chest Possible Difficulty breathing ?? Fingers and tongue tingling or numb Dizzy and fainting if attempt to get up or sit up ( needed ambulance but could not unlock door or call) Severe pain everywhere Feet cold and numb( no fever) After 7:30 am 4/10/2021 just very mild pain,fever,fatigue.
49 2021-04-10 hot flush Severe Diarrhea for 27 days Severe muscle contraction, stiffness, and pain on neck, shoulders, back,... Read more
Severe Diarrhea for 27 days Severe muscle contraction, stiffness, and pain on neck, shoulders, back, and chest for 7 days Hot flashes Night & day sweats Weight loss
49 2021-04-10 migraine, hot flush Migraine headache and nausea the first night and next day and again 6 days later. Dizziness and naus... Read more
Migraine headache and nausea the first night and next day and again 6 days later. Dizziness and nauseas for 8 days. Hot flashes intermittently continually and at present.
49 2021-04-10 migraine Migraine headaches, nausea, sneezing, conjested, ear ache, body ache, tired
49 2021-04-10 muscle spasms Muscle spasm/pain started in my left upper back/shoulder two days after the vaccine. Over the course... Read more
Muscle spasm/pain started in my left upper back/shoulder two days after the vaccine. Over the course of the following two days the pain/spasm spread across my entire upper back/neck/shoulders until I couldn?t move at all and was in tears from the pain. I took 5 ibuprofens in the afternoon and rested on a heating pad until roughly 10:00. Then I took 5 more ibuprofens and went to bed. Woke up (Sunday) still very tight and sore but at least I could move my arms. That afternoon a severe sore throat developed. Can hardly swallow now.
49 2021-04-11 weakness Sudden sharp drop in blood pressure, weakness, dizzy. Resolved in 2 days with rest, water, salt.
49 2021-04-11 numbness Immediately following injection, she reported onset of nausea and headache. Had several episodes of... Read more
Immediately following injection, she reported onset of nausea and headache. Had several episodes of vomiting. The following day 4/11/21, woke up with numbness in bilateral hands and feet that was new. Numbness has resolved as of 4/12/21. Continues to have nausea and fatigue
49 2021-04-11 pain in extremity, numbness Topical numbness of forehead, nose, and top front teeth. Forehead and tooth numbness Adverse sympto... Read more
Topical numbness of forehead, nose, and top front teeth. Forehead and tooth numbness Adverse symptoms resolved within 18 hours (not noticeable next morning when I woke up at 7 a.m.). Nose numbness duller but persisted for about 24 hours after onset. Numbness can be described akin to Novocain. Additional (common symptoms): Fatigue and thirst on set about 2 hours after injection. Sore arm after about 6 hours of injection. Sore arm persisted for about 4 days. Of note: NO loss of taste or smell. NO fever.
49 2021-04-11 pain in extremity Sore Arm for 3 days, Slight headache that only lasted that evening, fatigue for 24 hours. Took tyle... Read more
Sore Arm for 3 days, Slight headache that only lasted that evening, fatigue for 24 hours. Took tylenol to help
49 2021-04-11 pain in extremity AE started about 10 to 12 hours after injection. Developed in order- sore arm, full body aches, chi... Read more
AE started about 10 to 12 hours after injection. Developed in order- sore arm, full body aches, chills, severe headache, fatigue, fever. All symptoms resolved in about 48 hours.
49 2021-04-11 tremor, tingling After fever, fatigue, chills, headache, runny nose and nausea for 24+ hours, by Wednesday, March 17,... Read more
After fever, fatigue, chills, headache, runny nose and nausea for 24+ hours, by Wednesday, March 17, 2021 I had most of the symptoms resurface that I had when diagnosed with Covid in July 2020: Neurological symptoms (buzzing in head, trembling hands, tingly scalp, dysgraphia), Respiratory symptoms (shortness of breath, especially with normal activity, coughing, chest tightness, pain in back/ribs, sore throat) and Cardiovascular symptoms (heart racing, skipping beats). Went to Urgent Care on March 18, 2021 and chest x-ray showed opaqueness in both lungs. Given another dose of steroids for inflammation, most symptoms went away except for SOB, coughing and heart racing and skipping beats. SOB lasted for approximately 1 week, heart racing and skipping beats lasted for 3 weeks. Fasting blood work on 3/29/21 showed significant increase in all cholesterol markers (30-40 points) compared to results from previous tests in 2020-2021. A1C also increased to pre-diabetic levels.
49 2021-04-12 migraine Severe visual aura/disturbance similar to severe migraine, followed by immediate disappearance of sy... Read more
Severe visual aura/disturbance similar to severe migraine, followed by immediate disappearance of symptoms
49 2021-04-12 pain in extremity Fever up to 101.7 for 6 hours. Chills, fatigue for 10 hours. L arm pain shoulder to forearm 24 hours... Read more
Fever up to 101.7 for 6 hours. Chills, fatigue for 10 hours. L arm pain shoulder to forearm 24 hours. Warmth and ache at injection site 48 hours. Two Tylenol to reduce fever when temperature reached 101.5. Symptoms resolved within 30 hours except warmth and soreness at injection site. Loss of appetite and food aversion has not resolved in the 5 days since the injection.
49 2021-04-12 pain in extremity Patient recieved vaccine at 10 AM at a school COVID clinic. She waited 30 minutes and went home. At ... Read more
Patient recieved vaccine at 10 AM at a school COVID clinic. She waited 30 minutes and went home. At around 11 AM, she felt pain in her neck and down her arm. She also stated she felt a little swollen in her throat, tongue, eyes, and ears. She said it was not swelling shut, but just an uncomfortable and never felt in danger. Her hands and chest also had a tightness and swelling to them. Later that night she had a headache behind her eyes. By Saturday she was fine with the "swollen" feeling. However, by Monday, she had a rash begin on her hands and stomach. The rash was described as a chicken pox rash. She said this just went away over the last couple of days and did leave very little scarring.
49 2021-04-12 tingling SOB, Tingling Hands, Heavy chest Vitals 1005-HR 85 BP-108/90, RR-20 Vitals 1030-HR 70 BP-110/76, R... Read more
SOB, Tingling Hands, Heavy chest Vitals 1005-HR 85 BP-108/90, RR-20 Vitals 1030-HR 70 BP-110/76, RR 20 Provided juice, and monitored, spoke with her until she was well enough to leave. Follow up phone call attempted that evening, reach her the next day and she was well.
49 2021-04-13 breast pain Horrible Pain in left breast. First occurred at 2 am 4/8. Loss of vision occurred at 3:05. Fell bac... Read more
Horrible Pain in left breast. First occurred at 2 am 4/8. Loss of vision occurred at 3:05. Fell backwards onto floor 3:05 am. Diarrhea, nausea, labored breathing and sweating profusely. Unable to walk. 3:05 am. Thought was having stroke.
49 2021-04-13 feeling hot, flushing I was monitored for 15 minutes after the shot and felt fine, so I left. Within about 5 minutes of le... Read more
I was monitored for 15 minutes after the shot and felt fine, so I left. Within about 5 minutes of leaving Pharmacy, my face became extremely flushed, hot and red. I thought my car was hot, so I turned on the air conditioning, but it didn't subside. No hives or any other reaction. When I got home, I called Pharmacy and was told it could be an allergic reaction and to take Benadryl and monitor for Anaphylaxis (go to ER if that happens). The Benadryl worked and I had no further symptoms. I was perfectly fine by that evening and into the next day.
49 2021-04-13 pain in extremity skin started peeling off my hands and feet on day four post shot. I had a sore arm for two days whic... Read more
skin started peeling off my hands and feet on day four post shot. I had a sore arm for two days which resolved quickly and my temperature spiked 1.5 degrees 18 hours after the injection and resolved in four hours
49 2021-04-13 pain in extremity Injection site warm and swollen. Axillary lymph node very enlarged and painful with pain radiating ... Read more
Injection site warm and swollen. Axillary lymph node very enlarged and painful with pain radiating up the right side of my neck, into my shoulder blade and down my right arm.
49 2021-04-13 pain in extremity After receiving my second shot of the Pfizer vaccine on 03/27/2021, On 04/04/2021, my left arm star... Read more
After receiving my second shot of the Pfizer vaccine on 03/27/2021, On 04/04/2021, my left arm started hurting and then it started swelling. The following 2 days, my ankles and legs got swollen.
49 2021-04-13 tremor Patient originally complained of feeling dizzy and lightheaded. She was laid to the ground. Her BP w... Read more
Patient originally complained of feeling dizzy and lightheaded. She was laid to the ground. Her BP was taken 3 times and rose from 177/104, 192/98, 199/108. Other symptoms reported include heart racing, legs shaking and weakness. EMS was contacted to check out the patient.
49 2021-04-14 weakness Sore and achy body, no energy, slept for two days straight. Also right side of my face swelled up an... Read more
Sore and achy body, no energy, slept for two days straight. Also right side of my face swelled up and became super itchy on the day after the vaccine, by the second day it was only my eye (swelled shut and looked like black eye). One day three after swelling down but still looks like black eye. Now on day 4 after- less swollen but still itchy and swollen and black.
49 2021-04-14 feeling cold, flushing Red flushing of the face with cold chills and nausea Started around 2:30 pm the day after vaccine an... Read more
Red flushing of the face with cold chills and nausea Started around 2:30 pm the day after vaccine and lasted around 16 hours.
49 2021-04-14 migraine fever of 102.5, migraine, chills, body aches and exhaustion (slept for almost 2 days (Wednesday and ... Read more
fever of 102.5, migraine, chills, body aches and exhaustion (slept for almost 2 days (Wednesday and Thursday 4/6 & 4/8) I felt fine on Friday
49 2021-04-14 pain in extremity, tingling Patient reports tingling and paresthesias and slight pain throughout her left arm , hand, and left s... Read more
Patient reports tingling and paresthesias and slight pain throughout her left arm , hand, and left side of her face beginning immediately after receiving the vaccine. She has no change in motor ability or vision. This sensation continued Day 1, lessened on Day 2, and worsened on Day 3. She sought ED attention on Day 4 due to concerns for a stroke.
49 2021-04-14 pain in extremity Sore arm
49 2021-04-15 bell's palsy, numbness Bell?s palsy, numbness, headache
49 2021-04-15 discomfort within a couple hours of receiving the vaccine i had a headache and felt tired. at 3am that evening... Read more
within a couple hours of receiving the vaccine i had a headache and felt tired. at 3am that evening i woke up with muscle, joint, bone aches that lasted through the night, uncomfortable enough that it prevented me from sleeping. I took tylenol the next morning and it felt better. by 2PM the next day I had a fever of 100. It increased to 101.5 by 6pm. i had chills, body aches, felt horrible (flu like). it started to go down around 9pm. I woke up the morning of the 16th feeling much better (vaccine was given morning of 14th), all symptoms gone, EXCEPT my armpit is hugely swollen and painful. it has grapefruit sized swelling and throbs. it is under my right arm, which is the same side I had the vaccination on.
49 2021-04-15 feeling hot On April 11th, woke up with a swollen left eye and upper cheek, with redness. On April 12th, woke up... Read more
On April 11th, woke up with a swollen left eye and upper cheek, with redness. On April 12th, woke up with left eye nearly swollen shut, and entire left side of face red and puffy. As the day progressed, blisters appeared and began weeping. Which does sound like it could be a poison weed, right? I had zero contact with any poison ivy, sumac, oak, etc. I had not changed my diet, changed any soaps/detergents, etc. Contacted primary care provider who diagnosed issue as poison ivy and prescribed 40 mg of prednisone for 3 days, 20 mg for 2 days. By Thursday April 14th, issue was not improving and my entire face was swollen, red, hot and itchy. Went to the urgent care clinic who conferred with my primary doctor and they decided to increase my prednisone treatment to 60 mg for 3 days, 20 for 3 days. As of today, April 16th, the prednisone treatment does not appear to be helping, as face is still red, swollen, hot and itchy. This has also spread to my neck area, but not any where else on my body.
49 2021-04-15 flushing Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tig... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild
49 2021-04-15 flushing Flushing/Sweating, dizziness; BP 157/93; HR 77 RR 17
49 2021-04-15 pain in extremity, tingling Pain at injection site, tingling on left side of face, slight feeling of left lip swelling (but didn... Read more
Pain at injection site, tingling on left side of face, slight feeling of left lip swelling (but didn't swell). On 4.16.21 sore left arm, entire body fatigued.
49 2021-04-15 pain in extremity 1. Non-anaphylactic allergy (itchy throat, swollen lymph nodes, generalized swelling (couldn't take ... Read more
1. Non-anaphylactic allergy (itchy throat, swollen lymph nodes, generalized swelling (couldn't take ring off))...about 15 mins after shot...took Benedryl 2. Severe headache...about 25 mins after shot...lasted almost exactly 24 hours...took tylenol 3. Injection site/arm pain...also lasted about 24 hours
49 2021-04-15 tingling, cold extremities Pt states she was feeling nausea cold hands and tingling fingers. Nurse and Fireman sat her down on... Read more
Pt states she was feeling nausea cold hands and tingling fingers. Nurse and Fireman sat her down on the cott for 15 min. VS BP 152/84, HR 111, OxSat 100%. @1154 pt no longer c/o nausea or tingling in her fingers. Pt felt normal. VS @ 1152 BP 153/94, HR 88, OxSat 100%. Pt was offered to stay for an extra 15 min and she declined and said she felt fine to be discharged. Pt had someone with her and he said he will be with her for the rest of the day. Pt stated that she will contact her PCP.
49 2021-04-15 seizure Patient was seizing while in wheelchair 10 min after receiving her covid vaccination. Moved to medi... Read more
Patient was seizing while in wheelchair 10 min after receiving her covid vaccination. Moved to medical tent, Seized for ~ 1.5 min. follwed by 2 30 seccond seizures following initial . Post ictal after seizures but airway maintained. no other clinical complications noted. pulse and BP was normal. 911 contacted transferred to Medical Center.
49 2021-04-16 burning sensation The left side of my face and neck are bright red and it burns
49 2021-04-16 burning sensation Severe skin reaction/hives/itching/burning on legs, chest, underarm, back, arms neck, scalp & now be... Read more
Severe skin reaction/hives/itching/burning on legs, chest, underarm, back, arms neck, scalp & now begging for on face. Started Saturday April 10th, now 1 week later, Saturday April 17th, it is still spreading.
49 2021-04-16 tremor, pain in extremity The next day, I had a headache, 102 degree temp, vomiting, nausea, chills, body aches, dizziness , d... Read more
The next day, I had a headache, 102 degree temp, vomiting, nausea, chills, body aches, dizziness , dehydration and diarrhea. I had no appetite from this time and for days after. I hydrated with water, and took Tylenol, but it had no real effect. Day 5 I drank Pedialyte mixed with water and was able to eat soup and keep it down. The fever above 100 degrees lasted through Day 4, then was low grade (99.9) through Day 8. Day 8 I still had a headache, low grade temp and shakiness/dizziness. Brain fog is all I can use to describe the inability to focus my thoughts during even the most mundane conversations. My left arm felt like it had been punched for 3 days after the vaccine was given.
49 2021-04-17 burning sensation her glands are still swelling; she still has excessive sweating; she is bleeding so much and feels l... Read more
her glands are still swelling; she still has excessive sweating; she is bleeding so much and feels like crap/Really bad periods the worst in 30 years; Burning of ribs Feeling like they are on fire; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in Arm Left on 29Jan2021 10:00 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included stress, allergies to Sulfa and Penicillin from an unknown date and unknown if ongoing. The patient was Intolerant to Codeine and Dilaudid. The patient previously took first dose of BNT162B2 on 08Jan2021 12:00 Lot Number: EL0142 for Covid-19 immunization and experienced Lymph swollen, Excess sweating, Headache and Sore. The patient experienced she is bleeding so much and feels like crap/really bad periods the worst in 30 years on 02Mar2021 02:00, burning of ribs feeling like they are on fire on 29Jan2021, her glands are still swelling on an unspecified date and she still has excessive sweating on an unspecified date. The outcome of the events was reported as Not recovered. Information on the lot/batch number has been provided. Other information has been requested.
49 2021-04-17 facial paralysis, speech disorder My mouth on the right side droops slightly; feel a wired dizziness that got worse; Blood pressure wa... Read more
My mouth on the right side droops slightly; feel a wired dizziness that got worse; Blood pressure was high; I was disoriented and I could not move my arms or legs; they were not able to understand my speech; I could not move my arms or legs; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: ER2613) in right arm on 26Mar2021 08:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Graves Disease (in remission), papillary necrosis of kidney, Raynaud's, fibromyalgia, breast cancer survivor. Allergies to medications, food, or other products: Morphine, Sulfa, Aspirin, Ibuprofen, Bactrim, Escitalopram. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid, cobalt sulfate, copper sulfate, ergocalciferol, ferrous fumarate, magnesium sulfate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, vitamin b12 nos, zinc gluconate (MULTIVITAMIN (16)), gabapentin, tizanidine, paracetamol (TYLENOL). Patient experienced: Less than 10 minutes in the waiting area (reported as 26Mar2021 08:15 AM), began to feel a wired dizziness that got worse and she was able to signal a nurse who was attending to another lady having a reaction in the same seating area. Blood pressure was high, she was disoriented and she could not move her arms or legs. According to the doctor and nurse, they were not able to understand her speech. Her mouth on the right side droops slightly. Patient was admitted on 26Mar2021 and discharged from hospital on 28Mar2021. Events resulted in Emergency room/department or urgent care, Hospitalization. Treatment included testing, IV. Covid test post vaccination on 26Mar2021 (nasal swab) was negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-04-17 pain in extremity Low blood pressure hypotension with a lot of sleep from 3/30/2021 to 3/31/2021. Arm pain going up to... Read more
Low blood pressure hypotension with a lot of sleep from 3/30/2021 to 3/31/2021. Arm pain going up to the head and back 3/29/2021 to 4/9/2021 Hives almost all over the body from 2/4/2021 to 3/4/2021. Burning in throat with pain 4 /? / 2021 to present. General malaise and sensitivity to allergies up to the present 4/16/2021 onset of urticaria controlled with Benadryl 4/16/2021 and 4/17/2021 fever.
49 2021-04-17 pain in extremity Aches and pains Chills Headache Fatigue Arm very sore
49 2021-04-17 tingling, pain in extremity, numbness At first I was ok then after a few hours I started to have light pain in the left leg where I was d... Read more
At first I was ok then after a few hours I started to have light pain in the left leg where I was diagnosed with neuropathy. The pain continued to increase until 11 PM where I was crawling in pain in bed, on the left side from the SI joint to my feet all my muscles were hurting, my leg was getting numb with pins and needles down trough my foot. It was clearly related to the vaccine as there was no traumatic event. It started to subside early morning. I kept the "heavy leg sensation for more than a week. The SI joint and muscles pain have decreased from a 9 to a 5,6 in 36 hours day stbutayed at that level until the 15th. My left foott was numb until 2 days ago. I had to take iburpofen 600 every 8 hours for more than a week now I am at 1 or 2 times a day and I had to increase by 25 mg my pregabalin intake 2 times a day. I would like to know if it safe to get my second dose given the fact that usually the immune system response is stronger with the second shot. The pain in my left leg was so high and so intense and the numbness was so strong that I thought I will loose the use of it
49 2021-04-18 weakness woozy feeling followed by 102+ fever, chills, muscle and bone aches, dizzy, headaches, chest pain/ti... Read more
woozy feeling followed by 102+ fever, chills, muscle and bone aches, dizzy, headaches, chest pain/tightness, stomach aches, low appetite, weight loss, fatigue, low energy, nausea, hives & itches. Not fit to operate machinery for 4 days post injection. Car sick as passenger. Could not even after 5 days complete a day of work (12hrs). Was banned from work until I documented I see a clinic. Phone appointment secured a lab referral, and the directive to eat 3x day, rest when tired, hydrate. I felt I have lost a week in a blurr of pain and discomfort, fatigue and sleep. Second week was so weak and tired, showering was a challenge.
49 2021-04-18 severe one side paralysis, weakness STARTING FEELING SLUGGISH/ TOOK A NAP/ THEN WHEN AWOKE COULD NOT MOVE LEFT SIDE OF BODY/ WENT TO ER ... Read more
STARTING FEELING SLUGGISH/ TOOK A NAP/ THEN WHEN AWOKE COULD NOT MOVE LEFT SIDE OF BODY/ WENT TO ER AND WAS DIAGNOSED WITH MINI-STROKE WITH POSSIBLE MS ---STILL FEELING WEAK
49 2021-04-18 migraine Headache and migraine that started within 20-30min from the vaccine shot. Metallic taste in mouth ... Read more
Headache and migraine that started within 20-30min from the vaccine shot. Metallic taste in mouth Increased Heart rate Body chills that began 4 hours after shot
49 2021-04-18 muscle twitching, tingling, tremor heart palpitations, pain/twitching/tremors in body (more prevalent on left side of body) dizziness,... Read more
heart palpitations, pain/twitching/tremors in body (more prevalent on left side of body) dizziness, tingling/feeling of pins and needles (sensation) in bilateral hands and feet. Tingly/ itchy feeling in face, headache and chills.
49 2021-04-18 tingling, slow speech 6 days after shot I started to feel tingling in my face, the arm pain where injection was started to... Read more
6 days after shot I started to feel tingling in my face, the arm pain where injection was started to hurt, upper shoulder and neck pain, shooting pains to the head, light headed, throat tightness, chest pains in middle and difficulty breathing and speaking. Slight chills and happened for 2 days - shoulder and neck pain is still lingering to date. took tylonol, iced all areas and motrin - and a lot of tears and prayers.
49 2021-04-18 tingling Tingling or prickling sensation in right leg only at calf. Frequency is about 5 times a day. Also ... Read more
Tingling or prickling sensation in right leg only at calf. Frequency is about 5 times a day. Also feels like: Pins & Needles and does not last long when it occurs, approximately a few seconds. But there was one yesterday (That felt stronger & lasted a little longer.)
49 2021-04-18 tremor pt reports feeling shaking and nauseous. rapid improvement. drinking juice
49 2021-04-18 unresponsive to stimuli Paramedic on location reported that patient received her first shot of Pfizer vaccine and patient ha... Read more
Paramedic on location reported that patient received her first shot of Pfizer vaccine and patient had a syncopal episode. Paramedics reported that the patient was unresponsive with snoring respirations. IV normal saline started and patient transported to ED. On arrival patient stated she has had syncopal episodes with needle sticks in the past. EKG and lab work normal Patient discharged in stable condition.
49 2021-04-19 feeling hot Patient reported feeling "very itchy" after receiving her second Pfizer vaccine Lot #EW 0170 while w... Read more
Patient reported feeling "very itchy" after receiving her second Pfizer vaccine Lot #EW 0170 while waiting in 15 minute waiting area. Patient taken to the med bay and vital signs at 12:10 p.m. 150/109, 88 HR, 99% O2. Patient stated that she was feeling "very itchy and hot." Benedryl 25 mg administered to patient. Vital signs retaken at 12:17 p.m. 145/89, 88 hr, 98% O2. Patient stated she was feeling "a bit better" at 12:25 pm. PHN advised patient to call 911 or go to ER if symptoms worsen. Patient's husband picked up patient and drove her home.
49 2021-04-19 numbness, tingling Persistent pain in upper right arm where injection was, burning, numbness sensation in upper arm, so... Read more
Persistent pain in upper right arm where injection was, burning, numbness sensation in upper arm, some tingling in fingers. Also has spread in other arm, similar sensation - this occurred 1 week after vaccination first shot, and has now persisted now on week 3. Initially told to put warm compress or cold with ibruprofen - that has not helped. The sensations are getting more pronounced, all day long, nothing helps. Also now getting shooting pains in my head, bad headaches.
49 2021-04-19 numbness and pain in extremities Neuropathy in one foot
49 2021-04-19 pain in extremity, tenderness For the first vaccine shot, no unexpected adverse event. Next day, arm was sore, red and tender. 4 d... Read more
For the first vaccine shot, no unexpected adverse event. Next day, arm was sore, red and tender. 4 days past injection, I started to feel woozy and nauseated. On the morning of day 5, I felt the same way and vomited my breakfast. Improved throughout the day. My nurse practitioner said it was likely not vaccine related and that a stomach flu had been going around. For the second vaccine shot, the next day I felt the same arm soreness, redness and tenderness coupled with fatigue and a bad headache. Day 2, I still had some arm soreness and tenderness but the redness had widened to be larger (about diameter of a golf ball). No other issues. Day 3 was when the kraken was unleashed. Arm still tender and sore. Redness ha
49 2021-04-19 pain in extremity Developed joint pain in wrists, ankles, hands, and knees associated with a maculo-papular generalize... Read more
Developed joint pain in wrists, ankles, hands, and knees associated with a maculo-papular generalized rash of uncertain etiology. RX today 4/20/21 with prednisone.
49 2021-04-19 tingling Lump in left armpit, same side as vaccine (second dose),, VERY painful and makes arm movement (up, ... Read more
Lump in left armpit, same side as vaccine (second dose),, VERY painful and makes arm movement (up, above, back, and neutral) very uncomfortable and painful. Pressing on the bump causes a dripping feeling under the skin near the left breast. Have a doctor's appointment coming up. Lie bump (tonight ulcer), painful Severe back pain (had to visit spine specialist), need further testing
49 2021-04-20 breast pain Two weeks after my second injection, I experienced extremely tender, very enlarged breasts (both b... Read more
Two weeks after my second injection, I experienced extremely tender, very enlarged breasts (both breasts), and sharp shooting pains as well. I equate the swelling and discomfort to the same feeling I had when pregnant or nursing. Then on Sunday, April 18th, the tenderness started in my left armpit. I am currently still experiencing these symptoms. I had a normal mammogram last June and I do not feel any lumps or nodules.
49 2021-04-20 slurring, numbness Face and tongue went numb, slurred speech, fingers went numb both hands, felt like throat was closin... Read more
Face and tongue went numb, slurred speech, fingers went numb both hands, felt like throat was closing
49 2021-04-20 flushing, flushing at 10:57 pt. c/o mild tingling of the lips and tongue, itching of the left upper and lower extremiti... Read more
at 10:57 pt. c/o mild tingling of the lips and tongue, itching of the left upper and lower extremities. Noted flushing on the face and neck. pt. denies any respiratory distress. 25mg Benadryl given via IM on the right deltoid. Rechecked pt. after 5 mins; stated feeling better. pt. stayed for additional 30 mins. after Benadryl was given. pt. symptoms were relieved; left under own power; driven home by partner.
49 2021-04-20 pain in extremity **EXTREME** fatigue the following morning. It was an extraordinary sense of fatigue that I have not... Read more
**EXTREME** fatigue the following morning. It was an extraordinary sense of fatigue that I have not experienced before Soreness in the arm(s) and upper back with both doses - I did take pain relief after second dose which helped tremendously
49 2021-04-20 pain in extremity The morning after, I woke up with severe aches in my bones and pain in my joints, head, and left arm... Read more
The morning after, I woke up with severe aches in my bones and pain in my joints, head, and left arm. My nausea made it difficult to eat or drink. I was dizzy. I had a fever of 101 F, chills, and fatigue. I spent a lot of time sleeping and woke up with wet clothes and sheets. This lasted three days. Symptoms gradually lessened. This was the first shot in the series.
49 2021-04-20 tingling, muscle spasms, pain in extremity "NONOCCLUSIVE DVT RIGHT PERONEAL VEIN." PT H/O CLOTTING DISORDER AND CHRONICALLY ON XARELTO 20 MG P... Read more
"NONOCCLUSIVE DVT RIGHT PERONEAL VEIN." PT H/O CLOTTING DISORDER AND CHRONICALLY ON XARELTO 20 MG PER DAY PROPHYLAXIS, SINCE 2014. HAS BEEN TAKING MEDICATION REGULARLY. NO KNOWN TRIGGER- DID COLD WATER SWIMMING 2 DAYS PRIOR TO ONSET OF SX (4/14/21) FEELS CONSTANT ACHING IN RIGHT MID CALF AND TINGLING FEEL RIGHT MEDIAL LOWER LEG JUST BELOW KNEE. STARTED WITH THE TINGLING/ BURNING FEEL RIGHT MEDIAL LOWER LEG BELOW KNEE 4/14/21, YESTERDAY (4/19) STARTED WITH CRAMPING PAIN MID RIGHT CALF JUST LIKE WHEN SHE HAS HAD DVTS IN THE PAST. NO CP OR SOB.
49 2021-04-21 burning sensation Extreme non stop aching. Nausea Temperature that ranged from 99 to 103 Chills Headache Very Sore t... Read more
Extreme non stop aching. Nausea Temperature that ranged from 99 to 103 Chills Headache Very Sore throat Burning when taking a deep breath
49 2021-04-21 numbness 4:45pm later that same day began having numbness in left arm and foot and Cramp in left jawline. Con... Read more
4:45pm later that same day began having numbness in left arm and foot and Cramp in left jawline. Contacted left message. Symptoms continued, I took three baby aspirin and called primary care doctor on duty. She called back and explained that the Pfizer wasn't the same as J&J vaccine and to take a Tylenol for discomfort. I took a Tylenol and went to bed. The next morning when I woke up, I had pain behind neck into right leading up to right side of my head. I took some water and meditated until time to go to work. I called primary care Dr. and left message. Pressure continued and numbness in left extremities continued. Friday when I woke up my lower right leg and foot were numb. I drank a bottle of water and ate a banana. I stayed awake until time for work. I called my primary care and left message with nurse. Primary care called back around 3:35pm. she discussed steroid and meds or ER. I suggested both, go to ER to see what outcome is and then steroid possibly. Numbness and pressure continued while at work. I took two baby aspirin when I got off work. Saturday morning, I went to ER. Ct Scan with and without contrast done on head and neck. Doppler was done and no clotting was detected at that time. I was told by Dr. to see my Primary care physician or come back to see ER if symptoms worsened. I contacted my primary care on Monday and left message. They called back and made appointment to see me in office for Tuesday. Dr. suggested to use steroid and I asked to do therapy. Wednesday night excessive pressure, numbness, tightness in jaw and front of neck. Contacted primary care Dr. and called Clinic to learn for Stroke Neurology. Thursday, saw fire stars twice throughout the day. Called Poison control and put in report. This is second VAERS report that I have made.
49 2021-04-21 numbness Immediately after getting the shot, I felt a heaviness on the arm (left) that was given the shot. T... Read more
Immediately after getting the shot, I felt a heaviness on the arm (left) that was given the shot. Then, that heaviness moved to my left leg, thighs, and calf. My joints (knees, elbows, etc.) are stiff and sore. My left calf feels numb and stiff like after getting a nasty leg cramp.
49 2021-04-21 night sweats Morning head aches, night sweats, sore throat and daily/tiredness.
49 2021-04-21 pain in extremity This was my second shot. On my 2nd day I could not lift my left arm. I could not lift it forward ... Read more
This was my second shot. On my 2nd day I could not lift my left arm. I could not lift it forward or to the side not even 1/2 an inch. Extremely painful to the touch. I had difficulties getting dressed, driving , working and horrible time sleeping due to the pain of the arm. This continued and saw my Dr. who gave me pain med naproxen 500mg. It helped slightly just taking edge off. After a horrible weekend I began using a heating pad and that seems to be helping. On Tuesday the 20th I had first sign of improvement. I was able to move my left arm to the side at a greater degree and the sensitivity to the skin is subsiding. I still cannot lift it forward and have an appointment scheduled with a specialist.
49 2021-04-21 pain in extremity Arm pain, body aches, skin rash
49 2021-04-21 pain in extremity Shortness of breath, right leg pain. DX DVT with saddle PE
49 2021-04-22 mild one side paralysis All this on the right side of the body. Injection site was on the right arm. Dizziness and weaknes... Read more
All this on the right side of the body. Injection site was on the right arm. Dizziness and weakness, swollen/painful lymph nodes (axillary, cervical, epitrochlear, under jawline and chin). Parotid gland swollen and painful. Entire right arm swollen with rash, Right check swelled. Right ear pain.
49 2021-04-22 numbness and pain in extremities Tinnitus, unresolved. Neuropathy in right foot. Resolved: joint pain, headache, fatigue.
49 2021-04-22 pain in extremity Caller describes soreness in her arm and swelling under her armpit
49 2021-04-22 pain in extremity I received my first Pfizer vax on 03/30/21. On 04/14/21 I started having some sensations in my right... Read more
I received my first Pfizer vax on 03/30/21. On 04/14/21 I started having some sensations in my right leg and on 04/19/21 I started getting pain in my right calf so I went to the Emergency Room where they performed an ultrasound and said I had a DVT in my peroneal vein in my right leg. I was prescribed 15 mg of Xarelto twice a day for 21 days. Prior to this incident I have been on Xarelton 20 mg/day for life since October of 2014 for an "idiopathic" blood clotting disorder.
49 2021-04-22 pain in extremity Sore swollen arm Headache Chills Fever of up to 103
49 2021-04-23 weakness At 09:50 BP 157/98,then 09:51 BP 161/101, At 08:58 am 167/80,At 10:13 BP 181/93, At 10:22, BP 165/98... Read more
At 09:50 BP 157/98,then 09:51 BP 161/101, At 08:58 am 167/80,At 10:13 BP 181/93, At 10:22, BP 165/98,At 10:24 BP 164/102, At 10:27 BP 167/99; Unable to work after the 2nd dose; I wasn't able to go back to work because of severe weakness; Dizzy; my BP went down to 90/60, 80/56; This is a follow-up spontaneous report from a contactable Nurse in response to HCP letter sent in cross referenced case. A 49-years-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in deltoid right on 14Jan2021 at 09:00 (at age of 49 years old) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration on 20Dec2020 as single dose for Covid-19 immunization. On 14Jan2021, the patient was placed on close monitoring after receiving the second dose for continuous pulse oximetry, O2 saturations ranged from 98%-100%. At 09:50 BP 157/98, HR 73, 99% O2 sat, then 09:51 BP 161/101, HR 100, SpO2 100%, at 08:58 am 167/80, HR 85, SpO2 94%. The PCP prescribed clonidine 0.1 mg as needed for SBP>160. The patient took 1 tab clonidine 0.1mg. At 10:13 BP 181/93, HR 63, SPO2 100%, at 10:22, BP 165/98, HR 59, 100% SPO2, at 10:24 BP 164/102, HR 77, 99% SPO2, at 10:27 BP 167/99 HR 74, 100% SPO2. Later the patient took 2nd dose of clonidine 0.1mg and at 10:36 BP 134/86, HR 65, SPO2 100%, at 10:47 BP 124/81, HR 65. The patient was released by employee health nurse. She was dizzy when she got home, her BP went down to 90/60, 80/56. The patient was unable to work after second dose because of severe weakness. The patient stayed in bed for 5 days. The patient went back to work on 19Jan2021. Treatment for the event blood pressure fluctuation was two dose of tab clonidine 0.1mg. The patient provided information regarding the reported adverse events with the use of the suspect product to the nurse and the nurse considered that the Pfizer product had a causal effect to the adverse event. The outcome of the events was unknown. Information on the batch number has been requested.
49 2021-04-23 feeling of body temperature change, hot flush Nausea; Sweating; Shortness of breath; It's going from hot, cold goosebumps; Not been able to run; E... Read more
Nausea; Sweating; Shortness of breath; It's going from hot, cold goosebumps; Not been able to run; Elbow, back, knee, ankle pain; Sleeping during the day, take a nap or be in the bed was quite unusual; Normal cough-cold; Fatigue; Hot flashes; chills; Change in heart rate; Muscle soreness and tightness; Muscle soreness and tightness; Whole body joint pain; This is a spontaneous report from a contactable other hcp. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 intramuscular, administered in Arm Left on 25Jan2021 09:45 (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation. The patient had no allergies to medications, food, or other products. There were no concomitant medications. The patient told that she experienced extreme fatigue, hot flashes, change in heart rate anywhere from normal baseline to heart rate 160s and without exercising heart rate goes up to 120, hot flashes, not really chills. She never really had a fever after the second dose and never got a headache. But she got the vaccine on the Monday morning at 9:45 at midnight at that night woke up and had chills and was like okay. Took temperature and had no fever. Took Tylenol and Motrin and slept for the next 24 hours, woke up. Pretty much slept 24 hours. It was normal kind of normal cough-cold, extreme fatigue. Got up Wednesday was okay normal activities by 3 o clock in the afternoon again was out for the work and worked 12 hour shift the next day was off and then. Patient stated that she online looked for side effects for COVID-19 vaccine. She received both doses. So first vaccine was on 05Jan and the second vaccine was on 25Jan at 9:45 in the morning. At midnight, Monday night, after the vaccine about 16 hours, woke up with chills. So felt like she had fever but was not having fever, was extremely hot sweaty, but no fever, actual temperature. As expected, was like - okay, these are just normal side effects. She took Tylenol and Motrin at that time and got back to bed. She slept all night and then was just asleep, pretty much slept the whole next day. She slept and got up, with some nausea, typical normal side effects to be expected. She woke up Wednesday, felt okay. Again, by Wednesday evening, started having extreme fatigue, went back to bed. She slept from 3 in the afternoon to the next day and had to work at the hospital on Thursday, worked 12 hours shift. It was Friday again, extreme fatigue, heard these all are normal side effects for about the first week. So, did not pay much attention to it. Patient further stated: and when I say extreme fatigue, I am a person that does not nap or sleep during the day. So for me to take a nap or be in the bed was quite unusual. So anyways, I noticed hot flashes continued and chills. And when I say chills it is not, it kind of gets like chill cold. I think it's going from hot, cold goosebumps, never a fever but extreme hot flashes, sweating, full body sweat, and noticed kind of like increases in my heart rate when I got hot, I am sure that's just normal, and that continued, and has continued now since the vaccine. It's not, the hot flashes are continuing. It's random that's just not in the night or not just during the day, they are kind of all over the place. They happen from like every half an hour on a bad day, to I might be able to get thought at night, sleeping all night, to 3 times a day, extreme fatigue. I usually run 4 to 5 miles every day, I have not been able to run. I have shortness of breath, the heart rate kind of increases, I tracked it. Normally, I run 50-60 at resting heart rate and without exercise it will shoot up to the 120 and it is random throughout the day. I am going in today, just to get some standard blood work to see, you know, what's going on. And again, just extreme fatigue, muscle soreness, elbow, back, knee, ankle pain, joint pain, not really joint pain, but just you know, that kind of.' Consumer was informed about the role of Pfizer Drug Safety. Consumer stated, ‘I called this morning and was disconnected, I was speaking to somebody and was disconnected.' (Not further clarified, hence, captured as Initial Report.) The patient stated, ‘Yes, I had no symptoms prior to the second vaccine. I did not really have anything from the first vaccine, it started like I said, about 16 hours after the initial vaccine like, woke me up at night at 12:30 am and I have been experiencing this since the vaccine, the second vaccine.' The patient stated, I got the vaccine at 25Jan2021, since I got the vaccine so this is week number 3. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: no fever, heart rate: 160s, heart rate: 120. Therapeutic measures were taken as a result of chills (chills) , sweating (hyperhidrosis). The outcome of events fatigue, hot flashes, chills, change in heart rate, muscle soreness and tightness, whole body joint pain was recovering and for other events was unknown.
49 2021-04-23 pain in extremity Severe chills; mild headache; Arm and pain all over; Arm and pain all over; This is a spontaneous re... Read more
Severe chills; mild headache; Arm and pain all over; Arm and pain all over; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and expiration date: not provided) in arm left on 16Feb2021, 07:30 AM as a single dose for COVID-19 immunisation. Patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiration date: not provided), via an unspecified route of administration in arm left on 26Jan2021, 07:30 AM as a single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that patient had experienced arm and pain all over, severe chills and mild headache on 16Feb2021, 08:00 PM. No treatment received for the events. Outcome of the events were recovered.
49 2021-04-23 pain in extremity Headache fatigue ringing ears . Rash all over but concentrated mostly on legs . Puss filled bumps/... Read more
Headache fatigue ringing ears . Rash all over but concentrated mostly on legs . Puss filled bumps/blister little boils ...varying in size but like bug bites, mostly itchy and a little painful. I have used cortisone cream, Calgary lotion and taken benadryl
49 2021-04-24 burning sensation, numbness, bell's palsy, pain in extremity Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pa... Read more
Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pain in her feet; dry eye and eye watering; Bell's palsy; Legs went numb; Feet burning; Arms went numb; Nausea; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 11:45 (Batch/Lot Number: ERG213) as a single dose for covid-19 immunisation. The patient's medical history included ongoing systemic lupus erythematosus diagnosed 17 years ago. The patient's concomitant medications were not reported. On 30Mar2021, the patient experienced headache and nausea, arms went numb on 31Mar2021, legs went numb and feet burning on 01Apr2021. On 05Apr2021, the patient was diagnosed with Bell's palsy. It was also reported that before the bell's palsy diagnosis she felt like she was getting a cold. It was further reported that on the first day the patient had a headache and nausea. The second day her legs went numb for 3 days, on 05Apr2021 she got Bell's Palsy. Patient cannot talk, symptoms were not treated in any way. Patient had numbness in her arms first and then it went to her legs. She later clarified her arms and legs are still numb. The headache started soon as she got the vaccine. Her nausea started 2 hours after the vaccine and lasted 8 hours. Her legs still bothering her. She still has pain in her feet. Before the Bell's Palsy diagnosis she felt like she was getting a cold. She had a headache on the right side of the face. Her tongue was numb 3 days ago. She can't close her eye all the way, it was causing headache, dry eye and eye watering. It was going into her nose. Her lip was moving, she cannot talk. She went to urgent care last night after her daughter asked why she was winking. Her lip was sagging and thought it was a stroke. They said the Bells Palsy was definitely from the vaccine. The outcome of the event nausea was recovered on 30Mar2021, Bell's Palsy legs went numb, arms went numb, feet burning was not recovered and unknown outcome for the event before the Bell's Palsy diagnosis she felt like she was getting a cold.
49 2021-04-24 flushing felt as if my throat was closing and I had problems swallowing; felt as if my throat was closing and... Read more
felt as if my throat was closing and I had problems swallowing; felt as if my throat was closing and I had problems swallowing; metallic taste in back of mouth first; warm flushing feeling across chest and out arms; This is a spontaneous report from a contactable consumer reported for herself. This 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8734) via unspecified route of administration in left arm on 02Apr2021 08:30 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included celecoxib (CELEXA). The patient previously experienced drug allergy with codeine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021 09:00, the patient experienced felt as if her throat was closing and had problems swallowing, metallic taste in back of mouth first, warm flushing feeling across chest and out arms. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received included EMS arrived and gave diphenhydramine hydrochloride (BENADRYL). The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The outcome of events was recovered. No follow-up attempts are needed. No further information is expected.
49 2021-04-24 hot flush, tingling immediately after getting shot patient reposted a hot chest, described as a hot flash. She remained ... Read more
immediately after getting shot patient reposted a hot chest, described as a hot flash. She remained seated and then described tingly, weak limbs, I did ask her if she was nervous, she does have anxiety and was nervous about getting the vaccine. patient left store after 20 mins feeling better.
49 2021-04-24 numbness she thought she had a blood clot; maybe it is MS (multiple sclerosis); possible septal infarct; weak... Read more
she thought she had a blood clot; maybe it is MS (multiple sclerosis); possible septal infarct; weakness in her left arm; losing her balance; vaccine was given up high on her arm, not 2 fingers down. She thought they had hit bone; less range of movement in her left foot; trouble walking; like someone who had a stroke; numbness; legs felt heavy climbing stairs; immediate pain when needle went all the way in and worse when vaccine went in; pain in shoulder joint; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Ep6955), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 18:00 (at the age of 49years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included anemia that is treated, living kidney donor, gastric bypass in 1999, gallbladder removal, hysterectomy, intussusception x2, migraines, high heart rate, and smoking. Concomitant medications included omeprazole (OMEPRAZOLE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously received Flu vaccine and Tetanus vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. She got the shot on 25Mar2021 on Thursday evening at 1800. She is 49 years old and has had all the flu shots and tetanus shots. She has never had one hurt so bad. She stated that the vaccine was given up high on her arm, not 2 fingers down. She thought they had hit bone. It was reported that the patient experienced immediate pain when needle went all the way in and worse when vaccine went in. The whole time it hurt really bad and her arm hurt severely for 2 days from 25Mar2021. She still has pain in shoulder joint. That aside wasn't a big deal, it went away even though the joint is sore. The following Monday 29Mar2021 in the evening, her legs felt heavy and she had trouble going up the stairs. Then she had complete numbness of her left leg, from her hip or butt crack to the tip of her toes. It was on the same side she had the shot. It was further reported that the patient's legs felt heavy climbing stairs then she woke Thursday morning with her left leg numb. She couldn't feel herself starting to have a bowel movement because the numbness went all the way up to that area. She went to the ER (emergency room) on Saturday night (03Apr2021) because she was afraid of a blood clot. An ultrasound was done on her left leg, CT of head and neck, and blood work with nothing found. She has numbness and less range of movement in her left foot with trouble walking and have had no improvement with calf being numb. It was further clarified that when she was Easter shopping, there was numbness in her foot was causing her to drag her foot around the store. It was like someone who had a stroke, with slight impairment on one side. Her foot slaps the floor. She doesn't have control of it, she can't flex her foot up and down at all and she has little movement in her toes, even now. When she went to the emergency room, she thought she had a blood clot. She is a kidney donor and is healthy over all except for anemia that gives her tingly toes since she was 30, off and on. She never had a body part felt so numb, other than when she sits on her leg wrong. They did a bunch of tests there. They did a doppler, CT scan, and an EKG (unspecified date) which was abnormal. Her EKG has never been abnormal before. It said possible septal infarct undetermined time. The doppler showed no deep or superficial blockages noted from her groin down to her toes/ankle. The doppler was to check for blood clots. They referred her to her primary care provider who said that she will do a neurological exam. She has weakness in her left arm as well. The weakness in her left arm was only told by the neuro touch test. The patient further clarified that she doesn't have less range of motion, it is really just pain (arm). She can still move her arm all the way. Her left side is weaker or less sensitive as far as the neuro test. She wasn't aware she had less feeling on her arm until the nurse said she did. Her arm pain is nothing significant, it can hurt when moving her arm. She had no leg pain or anything like that until later in the week. She still had symptoms of losing her balance. Getting in and out of the chair she almost fell down. She didn't realize the numbness. Monday, she felt heaviness going up the stairs. For 2 days she had the worst pain ever in her arm. She had the tetanus shot and didn't have anything like that. It went away, when she raises her arm off from the side, she still has pain in the joint. She has migraines, it is nothing that is causing difficulty. She is more concerned something else happened. Patient thought maybe it is MS (multiple sclerosis) and asked if it is peripheral artery disease. She did smoke half a pack every other day. She is 49 but didn't start smoking till she was 36. It is a terrible habit and her doctor is aware. She also had her good and bad cholesterol which was just over 100. She is just reporting it because it happened on only the left side and she is a healthy person. She never had high blood pressure and never been treated for it, but she has had high heart rate before. It is not something that has ever caused any issue. She doesn't have something like peripheral artery disease, when she (software company name withheld) that is said plaque in the arteries. The doppler showed no signs of blockage superficial or deep on that side. She doesn't have an appointment until 29Apr2021. She doesn't know what to do to get more urgent care. The pain in her arm was better after the first 2 days. It is like a tooth ache, a dull ache. It is not all the time, just when moving her arm. Her legs were worse to where Thursday, she woke, and she was numb from the top of her leg to the tip of her toe. She can still lift her leg, but when she walks the tip of her second toe which is longer will drag on the ground. When she walks it is hard to hold her shoe on the left foot or put her shoe on. She can't maneuver her foot. When her foot hits the ground, the ball area of her foot smacks the floor because she doesn't have control over it. It is laboring to walk and is hard. She was kind of limping and pulling that leg on the left side. Her laboratory tests were BMP, CBC auto diff, CBC with diff, CT, angiogram of the head and neck, EKG 12 lead, and they did a venous doppler of the left lower extremity. It all came back good except the EKG which says septal infarct undetermined date, which has never come up on any tests before. The events resulted in Emergency room/department or urgent care, Disability or permanent damage. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.
49 2021-04-24 migraine Fever 101.5; body aches; chills; skin sensitivity and migraines (severe and hard to treat).
49 2021-04-24 pain in extremity, weakness Passed Quickly; Severe Dizziness; very weak; Arm Hurt; Chills; This is a spontaneous report from a c... Read more
Passed Quickly; Severe Dizziness; very weak; Arm Hurt; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on an unspecified date (at 49-years of age) for Covid-19 immunization. Patients medical history and concomitant medications were not reported. She had an allergic reaction to CAT scan contrast dye in the past. It was reported that after the first dose of the vaccine, within several minutes, she felt dizzy and it passed quickly. 4-5 hours later patient got severe dizziness and her family had to walk her to her bed. She was very weak and very dizzy so she laid down. She was dizzy in the morning and then was only mildly dizzy for a number of days. She also had chills and her arm hurt. She stated she saw dizziness at the bottom of the sheet as a more serious reaction and wanted to know if she should get the next dose of the vaccine? Patient also stated she heard that one dose of the vaccine is over 80% effective. No PQC was present. It was reported that patient did a report. Patient was guided to read form PI section 4. Read from Fact sheet under "WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?" regarding the description of serious allergic reactions. Referred to HCP for further discussion. PI: LAB-1457-7.0/ Revised: 06Apr2021 Fact sheet: LAB-1451-4.0/ Revised: 06Apr2021. The patient has a question if she is still considered vaccinated with just one dose? Is it 80% effective? Patient was asked to read from attached document. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-04-24 tingling, numbness Chills, numbness, tingling from shoulders to hands (tip of fingers), swelling of lymph nodes Sympto... Read more
Chills, numbness, tingling from shoulders to hands (tip of fingers), swelling of lymph nodes Symptoms are getting worse since Wednesday
49 2021-04-24 tingling I waited about 30 minutes. Felt tingly and a bit light headed but cracked it up to being tired from... Read more
I waited about 30 minutes. Felt tingly and a bit light headed but cracked it up to being tired from the shot. I got in my car and about 5 minutes out driving in the middle of traffic, I felt like I was going to pass out like I had once before with anaphylaxis- at the wheel. There is no mistaking the feeling. I could not feel my pulse at all. Fortunately I had a EpiPin in my car and I was able to jab it in my leg and within a minute or two I had the energy to turn the car around and get back to the folks at site who were wonderful. I then took benadryl as advised and the EMS were called. I was taken to site where they gave me a steriod, pepsid and monitored me until I went home later that evening. I was told to take benadryl for the next 24 hours and I did.
49 2021-04-25 burning sensation, tingling, feeling cold It's been almost a week and the build up of how crummy I've been feeling since my second vaccination... Read more
It's been almost a week and the build up of how crummy I've been feeling since my second vaccination seems to just get stronger. I feel like I may have hit a plateau. I have dealt with the tingling, the internal incessant itching, the burning and the shocks I get. But since the last shot I received the burning has intensified. The pain seems deeper as well, like a toothache. My hands have been really on fire for days. It's been a bit difficult to type for work. I can't sit still as the nerves from my knees down make my legs and feet feel as if they are asleep, like there's a tourniquet below the knee keeping blood flow from getting any lower. I hated clothes with tags as they would hurt but now I can't get away with any of it, nothing with tags, if they have one, they get cut off. Even getting goosebumps is really is painful. And no matter what, I'm always cold. It's exhausting getting comfortable.
49 2021-04-25 numbness, burning sensation I felt like it burned inside my arm, going up my neck and reaching my head, tired, headache and dizz... Read more
I felt like it burned inside my arm, going up my neck and reaching my head, tired, headache and dizzy, but the most important thing is that the left side is asleep as if it had anesthesia. Today, the arm is still the same. with pain and goes down into the bottom of my armpit and continues towards my chest.
49 2021-04-25 pain in extremity I initially only had a mild response with a sore arm, mild headache and slight nausea. About 36 hour... Read more
I initially only had a mild response with a sore arm, mild headache and slight nausea. About 36 hours later I woke in the middle of the night with severe chest and back pain, the same that I get when I have a eosinophilic esophagitis reaction to a food allergy, however I am certain that I did not consume any of the foods I am allergic to. This lasted for a couple of hours I then took a 5 mg prednisone (as prescribed by my allergy doctor) which eventually helped. I then had flu like symptoms (fever, chills, general malaise) for about an hour. I was then able to go back to sleep and woke feeling okay and those symptoms have not returned.
49 2021-04-25 pain in extremity Right arm sore 5-7 days Fevers off and on 15+ days, getting worse, now up to 100.9 degrees Very tir... Read more
Right arm sore 5-7 days Fevers off and on 15+ days, getting worse, now up to 100.9 degrees Very tired Eyes burning Body aches Dizziness when standing up. Nausea Stuffy nose Symptom have persisted since injection, some have worsened.
49 2021-04-25 tingling, pain in extremity Slight headache and sore arm day after Woke up on 4/22 with hearing loss and loud tinnitus in right ... Read more
Slight headache and sore arm day after Woke up on 4/22 with hearing loss and loud tinnitus in right ear, moderate tinnitus in left ear, tingly feeling extending from top of head down right side of face into neck. Scheduled appointment with an ENT for later in the day. Ear canals looked fine. She placed me on prednisone, symptoms have diminished (tingling sensation gone) vibrating sensation of eardrum reduced, hearing loss still persistent and still have tinnitus.
49 2021-04-26 weakness, tingling, numbness, feeling hot Pt given vaccine by provider @1440. Pt to wait for 30 mins. After 20 mins (1500) Pt reported not fee... Read more
Pt given vaccine by provider @1440. Pt to wait for 30 mins. After 20 mins (1500) Pt reported not feeling well. Pt given water and vitals checked. BP 110/60, HR:73, SPO2: 98%. zPt attempted to get up and move to exam room and then reported feeling like she was going to "pass out"/ Pt attempted to sit . About 30 seconds later pt was unconscious. Pts LOC lasted 30-60 seconds. Pt then seemed awake and reported she went to "dream land" and thinks she passed out. HR was med 70's, SPO2 99-100%. Pt moved to room by LPN and physician. Pt seemed slightly out of it and state she felt weak , hot and dizzy. Pt reported having tingling in both arms and felt very tired. Pt laid on exam table and continued to monitor x 90 mins total. Vitals taken @1525 BP:108/62, HR:68, SPO2:100%. Pt continued to c/o tingling and numbness in all 4 extremities. Pt shaky and continued to look pale. Pt attempted to sit up and reported feeling lightheaded and weak. Pt contact husband to pick her up. Husband arrived and pt's vitals were continually WNL. Pt advised per physician to go to ER as she is unable to stand w/o feeling dizzy. Pt taken to ER via wheelchair by LPN and provider.
49 2021-04-26 bell's palsy I have Bells Palsy I know at least one other person who lives near me with the same How can this b... Read more
I have Bells Palsy I know at least one other person who lives near me with the same How can this be so rare ? I'm so afraid to get the second shot Please tell me something
49 2021-04-26 breast pain 03/04/2021: Abdominal pain which required evaluation in the ER ER physician ordered urinalysis (nor... Read more
03/04/2021: Abdominal pain which required evaluation in the ER ER physician ordered urinalysis (normal), she reported that the ER did an ultra-sound and blood draws. CBC lymphocytes slightly low 22.5 %all other in normal range Normal Serum glucose, Renal and hepatic function tests. Discharged with tylenol, diagnosis of inflamed GI system. 04/08, Pain irradiated to ?right shoulder? just below the clavicle, ?shortness of breath? . ER second visit testing : COVID-19 PCR, Hemogram, arterial gases, Blood chemistry. Results: Hemogram WNL Glicemia: 96mg/dl Kidney function tests WNL Arterial gases: pH 7.46, pCO2: 32.7mmHg pO273.3mmHg SO2 95.4% HCO3 22.50mmol/L FiO2 0.21 COVID-19 PCR negative April 16, 2021: continued pain in right upper chest, radiating to mid-breast. Hurts to breathe deeply. No fever, no other signs/symptoms, referral consultation with Internal Medicine, specialist ordered VES, CRP, COVID-19 PCR, Abdomen and pelvis CT scan, Abdomen ultrasound, chest CT scan, these were performed on 4/20 On 4/24 Pain in chest continues, specialist ordered D-dimer. On 4/25 Dr. ordered arterial gases a Chest angio CT, abdomen doppler ultrasound and lower limb bilateral doppler ultrasound. Currently patient hospitalized, receiving treatment with blood thinners.
49 2021-04-26 numbness Patient began experiencing numbness in entire right arm, especially in right hand since morning afte... Read more
Patient began experiencing numbness in entire right arm, especially in right hand since morning after first dose (4/7/21) until now (4/27/21). Symptoms have not improved. Patient will follow-up with MD.
49 2021-04-26 numbness Patient reported feeling numbness in jaw and dizziness. Pt's lips, tongue, and skin were assessed wh... Read more
Patient reported feeling numbness in jaw and dizziness. Pt's lips, tongue, and skin were assessed while vital sigs were taken. She did not display swelling or discoloration in or around mouth or skin. The patient answered no when asked about difficulty breathing, itchiness, or shortness of breath. Initial vital signs were 160/107 HR 94 Sp02 98%. She reported a previous anaphylactic reaction to oxycodone and believes she was given IV epinephrine. Vitals were rechecked 5 minutes later and were 147/97 HR 92 Sp02 100%. Pt reported feeling numbness in chest and EMS was called at 1551. Pt was taken via ambulance when EMS arrived. Pt has a history of severe asthma and 2012 allergy testing was negative. Pt rec'd 2nd dose on 4/14/2021 with no known issues.
49 2021-04-27 weakness The injection was higher on the shoulder instead of on the muscle it was closer to the acromion proc... Read more
The injection was higher on the shoulder instead of on the muscle it was closer to the acromion process, noted shoulder pain a few weeks after the first dose that didn't get any better. Certain motions trigger the pain, sharp pain that lasts several minutes. Hard to sleep as worse at night. Debilitating, lost strength and significant loss of motion. Doing physical therapy exercises but doesn't help. Worsening pain as the weeks rolled by. Hand an Xray today and shows "distal infraspinatus tendon calcium hydroxyapatite deposition, correlate for calcific tendinopathy" which on a previous Xray did not show (Chest Xray). Since I was the first few that received the Covid vaccine, I have a picture of where the injection was place and that is exactly where the now calcium hydroxyapatite deposition is.
49 2021-04-27 cold sweat This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-o... Read more
This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0158 and expiration date not provided), via an unspecified route of administration administered in the right arm on 11Apr2021 14:00 as a single dose for COVID-19 immunization. Medical history included Crohns Disease. The patient is not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has no known allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 12Apr2021 01:45, about 12 hours after the first dose, the patient passed out and then broke out in a cold sweat, multiple times. No treatment was given in response to the events. The outcome of the events was recovering. The patient has not been tested for COVID post vaccination.; Sender's Comments: Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-04-27 migraine Migraine headache - few hours after the shot Vomiting - 11:45pm Fever all day 4/27 Chills all day 4/... Read more
Migraine headache - few hours after the shot Vomiting - 11:45pm Fever all day 4/27 Chills all day 4/27 Headache all day 4/27
49 2021-04-27 night sweats Chills, night sweats, muscle and joint ache, slight throat pain, lymph node swelling in right arm pi... Read more
Chills, night sweats, muscle and joint ache, slight throat pain, lymph node swelling in right arm pit, slight loss of appetite
49 2021-04-27 tingling, numbness C/O anxiety admits to having increased anxiety. Also c/o numbness and tingling to l arm. Sent to ems... Read more
C/O anxiety admits to having increased anxiety. Also c/o numbness and tingling to l arm. Sent to ems for further eval.
49 2021-04-28 weakness, feeling cold I felt back pain and on Apr. 26th. Then I thought it will be ok soon. But in the next 2 or 3 days,... Read more
I felt back pain and on Apr. 26th. Then I thought it will be ok soon. But in the next 2 or 3 days, I felt weak, joint pain and cold. Then I test my body temperature. It was over 100. Today, I still felt back joint pain, a little headache and have low fever. But I did not cough and was not shortness of breath.
49 2021-04-28 migraine positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach pains; nausea; diarrhea; migraine; dizziness; body aches; faint; This is a spontaneous report from a contactable consumer reporting for self. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 10:00 (Batch/Lot number was not reported) at the age of 49 years old, as single dose for covid-19 immunisation. Medical history included allergies to penicillin, codeine, Bactrim, sulfa drugs. Concomitant medications included alprazolam; sumatriptan succinate (IMITREX); amitriptyline. The patient experienced Chills, Fatigue, stomach pains, nausea, diarrhea, migraine, body aches, dizziness, faint from 01Apr2021. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient had Nasal Swab on 07Apr2021 with negative result, and on 13Apr2021 with Positive result. Outcome of event COVID-19 virus test positive was unknown, of other events was not recovered. Information about lot/batch number has been requested.
49 2021-04-28 tingling This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old fem... Read more
This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 49 years old at other facility type. The patient is not pregnant at time of vaccination. Medical history included allergies to Rosemary from an unknown date. No other vaccine in four weeks were noted. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); propranolol hydrochloride (INDERAL); lorazepam (ATIVAN); hctz; quetiapine fumarate (SEROQUEL); gabapentin taken for an unspecified indication, start and stop date were not reported. The patient previously took macrobid [nitrofurantoin] and experienced allergies. The patient previously received the first dose of BNT162B2 (Lot number: ER8727) on 17Mar2021 13:00 (left arm) for COVID-19 immunisation. On 10 Apr2021, the patient experienced Itchy palms (reported as within hours), tachycardia, tightness in chest, difficulty breathing, tingling tongue and fingers, vomiting, confusion, dizzy, fainting, abdominal pain, severe pain everywhere, too fatigued to move. Patient tried to call ambulance but could not get phone or unlock the door. She stated she tried from 1 AM to 07:30 AM. After 07:30 AM she had expected effects of fever as well as fatigue and pain. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not given. Outcome of the events was recovered on an unspecified date.
49 2021-04-29 difficulty speaking Went to ED after vaccination reaction - diagnosis: Anaphylaxis CHIEF COMPLAINT: POSSIBLE ALLERGIC ... Read more
Went to ED after vaccination reaction - diagnosis: Anaphylaxis CHIEF COMPLAINT: POSSIBLE ALLERGIC REACTION (ptjust had 2nd COVID vaccine. c/o voice changes and changes in swallowing. pt is able to maintain secretions at triage. ) DIAGNOSIS at time of disposition: 1. Anaphylaxis, initial encounter This is a 49-year-old female that presents emergency department 1 hour after receiving her 2nd COVID vaccine (pfizer), and states that she waited her 15 minutes after receiving the shot and felt fine. She then reports that when she got to the car she started feeling some chest tightness a bit of more difficulty with her breathing and felt like her throat was scratchy and a bit tight as well. She has had complications with taking the flu vaccine as well as a tetanus shot. Where she has had rashes then enlarged lymph nodes. But never this reaction. She has never been hospitalized or brought to the ER due to anaphylaxis. She does not use an epinephrine pen at home. Patient states before the shot she was feeling well. She does not have any systemic symptoms like fever, nasal congestion or sore throat. Patient also denies any recent episodes of vomiting or diarrhea. This patient came in the emergency department was concerning signs and symptoms for anaphylaxis. The patient was immediately given a dose of IV Solu-Medrol 125 mg, IV Benadryl 50 mg, and 20 mg of IV Pepcid. Patient was placed on cardiac monitor. I went back to re-evaluate the patient she was feeling significantly improved within a short period of time. Patient was monitored in our emergency department for most 2 hours. Patient's symptoms had resolved. Patient was comfortable being discharged home. Patient has several allergies in her history. Patient was sent home with a prescription for prednisone as well as Pepcid. Patient also given a prescription for an epinephrine pen and told and instructed on how and when to use this. The patient is going to have someone pick her up as she was instructed that the Benadryl can make her very drowsy and a would be rather unsafe to drive. She was going to contact a family member to pick her up. Patient will return if she has any more symptoms
49 2021-04-29 feeling hot Rapid heart beat after approximately 90 minutes after injection, lasting for about 2 hours. Hands an... Read more
Rapid heart beat after approximately 90 minutes after injection, lasting for about 2 hours. Hands and feet became abnormally hot to the touch after that. Extreme fatigue the morning after the injection. Slight chills and whole body aches. Injection site really sore for over 30+ hours after injection.
49 2021-04-29 tingling pt was administered covid19 Pfizer vaccine and was told by rph to stay for 15 minutes for any side e... Read more
pt was administered covid19 Pfizer vaccine and was told by rph to stay for 15 minutes for any side effects or reactions. After about 5 minutes, pt stated started feeling light headed, dizzy, and sweaty and not feeling good. She was given some water at which point she stated she was starting to feel tingly all over. Paramedics were called and came within 5 minutes. About 15 minutes later pt was able to walk out of the pharmacy with paramedics and drive home.
49 2021-04-30 weakness Felt weakness and lethargic all day long; developed neck pain on the same side as injection. Day aft... Read more
Felt weakness and lethargic all day long; developed neck pain on the same side as injection. Day after injection (Saturday), neck pain was severe; severe major joint pain; Also, muscle and skin pain all over my body; Also, muscle and skin pain all over my body; Overall feeling of malaise; Felt weakness and lethargic all day long; Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did; The day of the injection (Friday), pain at sight was very strong.; That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021 (Batch/Lot Number: ER8732) as single dose in left arm at the age of 49-year-old for COVID-19 immunisation, administered at healthcare facility. Medical history included Heterozygous Factor 5 Leiden, narcolepsy, total knee replacement 13 months before in 2020, arthritis, chronic low vitamin D levels, sites of previous injuries from years earlier that had healed. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received Effexor and experienced drug hypersensitivity. The past vaccination history included the 1st dose of bnt162b2 (Lot number EN6199) as single dose in left arm on 05Mar2021 for COVID-19 immunisation. No other vaccine in four weeks. On 26Mar2021 03:45 PM, the day of the injection, pain at sight was very strong. That night (26Mar2021), developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms), and also developed neck pain on the same side as injection. On 27Mar2021, day after injection, neck pain was severe, and developed severe major joint pain throughout body. Also, muscle and skin pain all over my body. Overall feeling of malaise. Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did. Felt weakness and lethargic all day long. All of these symptoms were gone by 28Mar2021 except for the neck pain which remained sever for 10 days, but has subsided slightly more for the last 5 days leading up to today (still suffering from neck pain today). No treatment received. Covid was not tested post vaccination. The outcome of pulmonary edema, cough, vaccination site pain, lethargic, joint pain, muscle pain, skin pain, malaise and weakness was recovered on 28Mar2021, of neck pain was not recovered. No follow-up attempts are needed. No further information is expected.
49 2021-04-30 burning sensation her symptoms started as a couple of dots at the injection site; The rash started growing all over he... Read more
her symptoms started as a couple of dots at the injection site; The rash started growing all over her body; Rash growing all over body was worsened; It is still burning and itching; It is still burning and itching; Neither of them can sleep; This is a spontaneous report from a contactable consumer (Patient husband) via Medical Information Team. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# unknown), via an unspecified route of administration on 01Apr2021 (at the age of 49-years) as single dose for COVID-19 immunisation. It was reported that the patient received vaccine 22 days ago. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, patient experienced symptoms that started as a couple of dots at the injection site that got worsen and started growing all over her body, it is still burning and itching, neither of them can sleep. There is no relief for her rash even after ten days. Patient visited the emergency room four times and has been to her primary doctor and her pain management doctor where she received six different prescriptions, of which three are from a hospital which prescribed over-the-counter medicine and asked to come back after seven days. But nothing helped and the rash is still growing like poison ivy. Reporter described that patient back looks like the surface of Mars as seen on a television channel. Nothing else was different in her diet or medications outside of the vaccine. Later, patient visited another hospital where she was prescribed with another medication. Patient received treatment with an unspecified intravenous (IV) medication which helped her to sleep. Reporter stated that none of the medication helped except the IV medication, considered so because it helped her sleep. Reporter was upset and thought that Pfizer vaccine gave the patient that rash. The outcome of the event insomnia was recovered and the outcome of the event condition aggravated was unknown while for all the other events, it was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-04-30 feeling hot after about 10-15 minutes patient started to experience dizziness and feeling hot and little sweatin... Read more
after about 10-15 minutes patient started to experience dizziness and feeling hot and little sweating. Sweating and feeling hot went away after 15 minutes but patient still complained about dizziness. I reached out to the patient at about 6:45pm to check on her and said she contacted the doctor and doctor advised to keep eye on her sugar since she is diabetic., the dizziness should go away in the next day. if not to call office and make appointment.
49 2021-04-30 hot flush I have had severe joint pain, lasted two weeks at that level and then seemed to be getting better. T... Read more
I have had severe joint pain, lasted two weeks at that level and then seemed to be getting better. This is why I didn?t bother reporting it, and I was still mobile during the pain. Then the bone/joint pain started to increase again. I called my doctor to inform her of what was going on and that I am now unable to walk, stand, sit due to the severity of the pain. Weak muscles. When I received the second dose I got slightly dizzy and felt a hot flash type symptom, it was very brief. I waited the required time before leaving the facility.
49 2021-04-30 numbness sinusitis, allergic rhinitis. the week after the vaccination I lost my voice and had a cough, then m... Read more
sinusitis, allergic rhinitis. the week after the vaccination I lost my voice and had a cough, then my legs started to sleep, and my petechiae again
49 2021-04-30 numbness Allergic reaction; itching from head to toe; rash; broken vessels in cheeks, turned red; difficulty ... Read more
Allergic reaction; itching from head to toe; rash; broken vessels in cheeks, turned red; difficulty breathing; arm went numb; was not feeling good; blotchy; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in right arm on 25Mar2021 14:30 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were none. No prior vaccinations within 4 weeks. The patient experienced itching from head to toe on 25Mar2021 with outcome of not recovered, rash on 25Mar2021 with outcome of not recovered, broken vessels in cheeks, turned red on 25Mar2021 with outcome of not recovered, difficulty breathing on 25Mar2021 with outcome of recovering, allergic reaction, arm went numb, was not feeling good and blotchy on 25Mar2021 with outcome of unknown. The events itching from head to toe, rash, broken blood vessels in cheeks and difficulty breathing require a visit to Emergency Room. No relevant tests. Clincial course reported as follow: Patient received her first dose 25Mar2021 and within 3 hours she was in the Emergency Department. She had an allergic reaction. She has had itching and rash since receiving the shot. The allergic reaction wasn't even 5 minutes of getting the shot her arm went numb and she thought she's in trouble and was this normal. She asked people running the clinic and asked if this was normal and they said no never heard of that. After that itching started. Itching started at her head and moved to her face and then her entire body. She had a rash on her face, neck and chest. The blood vessels broke in her cheeks. She knew she should have some diphenhydramine hydrochloride (BENADRYL) and the emergency department didn't have any there. The staff made her wait for 30 minutes after her injection. She was not feeling good. It was hard for her to take a deep breath, and to catch her breath after 30 minutes of waiting there. Then she drove herself to store and got diphenhydramine hydrochloride, and drove herself home, she was not feeling any better and took the diphenhydramine hydrochloride. She called her doctor's office. It was like an hour after the shot and she told them at the doctor's office she was blotchy, itchy, and having trouble breathing. She talked to the nurse and was advised she must got to the Emergency Department. The nurse told her that the staff should not have let her leave the facility where had shot administered and should have called an ambulance and did not. The staff did not even have diphenhydramine hydrochloride. She went to the Emergency Department and she was still itchy. It had been since 25Mar2021. The rash was mainly on both sides of her neck and under her ears. It comes and goes. She confirmed outcome as persisting. The broken vessels, turned red, under her eyes were no better. She would get spells of difficulty breathing. She couldn't get a deep breath for about a week after the shot and it has gotten better. No follow-up attempts are needed. No further information is expected.
49 2021-04-30 tingling Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specif... Read more
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Pt reported having issues with first vaccine very similar to this , head tingling and chest heaviness and nausea within 10 min of vaccination. Gave diphenhydramine liquid at 10 min. Blood pressure normal. Pt stayed 30min for observation was ok and left with husband.
49 2021-05-01 muscle spasms, migraine 2nd dose, Woke up following day with slight headache and some joint pain. As the day progressed hea... Read more
2nd dose, Woke up following day with slight headache and some joint pain. As the day progressed heading into the 24 hour mark of the shot my headache turned to migraine, soreness all over, joint aches- cramps in ankles, knees and hips, extremely tired but unable to sleep. Slight congestion, soar eyes and headache continued for 2nd day- still present as of 5/2
49 2021-05-01 pain in extremity, hot flush Day 1. After 15 minutes, intense hot flashes, continued all day, Left arm sore, swollen, nausea, sli... Read more
Day 1. After 15 minutes, intense hot flashes, continued all day, Left arm sore, swollen, nausea, slight headache. Day 2. Hot flashes, less intense, nausea, sore throat, slight headache, post nasal drip, slight cough and sneeze, Day 3. Swollen lymph nodes in throat, lost voice, chest sternum pain, slight headache, fatigue (called Dr). Day 4. No voice, body aches, nausea, head ache, chills, body aches, fatigue,post nasal drip, slight cough and sneeze . Day 5, chest and back pain, body aches, nausea, heartburn, still no voice, post nasal drip, slight cough and sneeze, headache, fatigue, chills. Day 6. Worst day of all! Intense headache that did not go away, almost went to Emergency Room, I was too tired to get up from the bed, body aches, chills, fatigue, still no voice, felt awful all day, I could not sleep because of the headache pounding, back hurt, it was painful to sneeze or cough,post nasal drip, slight cough and sneeze.. Day 7, Feeling slightly better, slight headache, body aches, post nasal drip, slight cough and sneeze. Day 8 felt 70% better, voice slightly returning.
49 2021-05-01 pain in extremity Very sore throat, headache, eustachian tube pain, swollen lymph nodes (base of throat, collarbone ar... Read more
Very sore throat, headache, eustachian tube pain, swollen lymph nodes (base of throat, collarbone area, possible armpit), all on side where vaccine was given. Had sore arm the day of, but stretching the muscle helped.
49 2021-05-01 pain in extremity The evening of the vaccine I had pain at the injection site that grew worse overnight. I repeatedly... Read more
The evening of the vaccine I had pain at the injection site that grew worse overnight. I repeatedly woke up whenever I rolled onto my left arm because of the pain. I took Tylenol the morning of the 30th. I started to get joint pain in my left elbow and fingers beginning around 9am. By 11am my whole body was sore and I was exhausted. At around 1pm I developed chills and a fever of 100.8. Beginning at 2pm I took 2 Tylenol every 4 hours. My temparature was between 99.8 and 101 until 05/01/21 at 9am. Besides the joint pain and fever, I had a headache, nausea and 2 enlarged lymph nodes: left armpit and left groin. The lymph node in my arm pit was hard, sore and got to be about as big as a small lime. It was so tender I could not put my arm down at my side. The lymph node in my going was enlarged but not as sore. I stayed in bed and slept from 5pm 4/30/21 to 9am 5/1/20. My temp when I woke up was 99.0. My only symptoms on 5/1/20 were headache and very large lymph node under left armpit. Although still large, it was softer than the day before. Today, 5/2/20 I still have headache and enlarged lymph node in left arm.
49 2021-05-01 pain in extremity Sore arm Fever of 103 Chills Headache Nausea Fatigue Body Aches
49 2021-05-02 burning sensation, tingling Hives, started on my arm on Monday, by Tuesday 04/27/21 hives increased to include my back also incl... Read more
Hives, started on my arm on Monday, by Tuesday 04/27/21 hives increased to include my back also included chills and prickly sensation I contacted my doctor (Unavailable) called MD doctor on Wednesday 04/28/21 hives over 80% of my body-chills, itching, burning the ordered Hydroxyzine 25mg 3x a day ; added Benadryl one tablet at night. on 4/30/2021 symptoms continued with no relief contacted my PCP she prescribed Famotidine 20mg 1 x a day. 05/03/2021 only slight improvement of rash but chills, itching still exist.
49 2021-05-02 cold sweat, tremor 6 Days after vaccine I experienced a Blood Pressure spikes 190/110 along with Extreme headache, palp... Read more
6 Days after vaccine I experienced a Blood Pressure spikes 190/110 along with Extreme headache, palpitations, clammy hands and shaking. I have had 5 spikes since. My doctor placed me on 2 Meds- 25mg Metropolol and 1mg Doxazosin daily. The episodes seem to have decreased since 4/27/21.
49 2021-05-02 hot flush Ringing in ears Hot flashes
49 2021-05-02 numbness Shortness of breath, LLE numbness. 911 called at 10:32AM.
49 2021-05-02 pain in extremity, muscle spasms A small pimple and under it a large lump appeared in the right thigh after 2 days of receiving the ... Read more
A small pimple and under it a large lump appeared in the right thigh after 2 days of receiving the shot then the 2 days after that the left thigh another huge lump after taking a 45 min walk, it turned into a large bruise and then cramping in my biceps and calfs also. They were hot to the touch and hurt a lot. I was not sure if they were clots. I had something similar that happened when I first took birth control pills at 24 yrs of age and had lumps on my legs if i just bumped them. I got off of those pills immediately. However, I never banged my upper thighs at all this was what I know is from this vaccination.
49 2021-05-02 pain in extremity 4:00am 4/28/21 - mild fever, chills, malaise/fatigue throughout the day. Moderate diffuse upper lef... Read more
4:00am 4/28/21 - mild fever, chills, malaise/fatigue throughout the day. Moderate diffuse upper left arm pain. Treatment with acetaminophen as directed on package. Fever/chills and malaise resolved by 4/29/21; arm pain reduced to mild and less diffuse. 7:30am 4/29/21 - pronounced left axillary lymphadenopathy 12pm 5/3/2021 - left axillary lymphadenopathy substantively resolved
49 2021-05-02 speech disorder STARTED WITH HEADACHE, CLOSELY RESEMBLED A MIGRAINE AS IT WAS JUST IN ONE EYE. BECAME SICK TO STOMA... Read more
STARTED WITH HEADACHE, CLOSELY RESEMBLED A MIGRAINE AS IT WAS JUST IN ONE EYE. BECAME SICK TO STOMACH, THEN BEGAN WHAT COULD BE IDENTIFIED A SEIZURE. BODY BECAME RIGID, A LOT OF PAIN, COULD NOT SPEAK, JUST MAKE SCREAMING TYPE NOISES,. LASTED ABOUT 3 MINUTES, THIS WAS REPEATED THREE MORE TIMES. FOLLOWING DAYS HAD OVERALL BODY ACHES, STILL HAVE TROUBLE WITH CONCENTRATION, EXTREMLEY TIRED.
49 2021-05-03 migraine, feeling hot 1st Vaccine shot-FRI APR 23, 0900 9hrs later, shot area sore, next morning SAT approx 330am woke up ... Read more
1st Vaccine shot-FRI APR 23, 0900 9hrs later, shot area sore, next morning SAT approx 330am woke up to migraine that lasted till noon SAT. Afternoon fatigue /tired / dizzy; *started weezing , nose felt stuffy-took 1 puff inhaler. Sun 25- breathing normal, no inhaler, but by mid day both hands-ALL fingers tight / stiff/ bones sore - pain lasted approx 1 day, stiffness in joints lingering. Mon 26- bone joint / stiffness somewhat subsides, constant Left hip bone pain, intermittent heat sensation / like hot flashes- ongoing until current. May 2-3-weezing is back, stuffy nose - 1 puff inhaler per day. May 3- approx. 0500am bright red blood found in stool. Stool normal size / color, blood in feces, no blood when I wipe. No odd smell, no difficulty in moving bowls, no stomach pain. Appetite & sleep pattern is normal, no fever.
49 2021-05-03 pain in extremity, breast pain Fever averaging at 100.9 from 4/13/2021 thru 4/21/2021. Severe pain and swelling under arm, directly... Read more
Fever averaging at 100.9 from 4/13/2021 thru 4/21/2021. Severe pain and swelling under arm, directly below arm pit. Swelling of arm minimized by 4/21/2021, but the pain under arm by armpit persists as of today 05/04/21. Extreme lethargy form 4/13/21 thru 4/18/2021. The extreme arm pain, fever and lethargy was significant enough to go to the hospital on 4/16/2021, but I did not have the strength to shower or get ready to be taken to the hospital. Thus, I continued sleeping till the next day 4/17/2021, where I felt well enough to get out of bed, but continued to have extreme pain under my armpit and near my left breast. Significant arm discomfort, impeding my ability to perform simple household tasks such as folding laundry or lifting heavy items. till present day: 5/4/21. Severe congestion since implementation of dose 1 of Pfizer Vaccine on 4/13/2021 till present day: 5/4/2021
49 2021-05-03 pain in extremity Sore arm Fever Headache
49 2021-05-03 tingling, pain in extremity, numbness PATIENT REPORTED TO PHARMACY FOR SECOND DOSE AND MENTIONED REACTION OCCURING TWO DAYS AFTER RECEIVIN... Read more
PATIENT REPORTED TO PHARMACY FOR SECOND DOSE AND MENTIONED REACTION OCCURING TWO DAYS AFTER RECEIVING VACCINE. IT STARTED AS AS PAIN THEN TINGLING AND NUMBING IN THE VACCINATED ARM. PATIENT USES OTC PAIN MEDICATIONS AND A HEATING PAD WHICH CAUSES SOME REDNESS IN THE AFFECTED ARMS
49 2021-05-04 numbness, pain in extremity, tingling Pt (Patient) started feeling confused; She had numbness and tingling on R side; She had numbness and... Read more
Pt (Patient) started feeling confused; She had numbness and tingling on R side; She had numbness and tingling on R side; pain in R leg; headache; This is a spontaneous report from a contactable Physician. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration in left arm on 27Jan2021 at 10:45 AM as single dose for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was allergic to penicillin. The patient medical history included TIA, angina, and restless leg syndrome. Concomitant medication included Asprin 81mg daily. On 29Jan2021 at 09:00 PM, the patient started feeling confused, had numbness, and tingling on right side, pain in R leg and headache. AE resulted in emergency room/department or urgent care. Treatment was received for AE. The outcome of the events was unknown.
49 2021-05-04 muscle spasms, migraine Several hours after vaccination once patient went home, started to develop full body muscle aches, c... Read more
Several hours after vaccination once patient went home, started to develop full body muscle aches, cramps, low grade fever, diaphoresis, and a debilitating migraine. Patient called the pharmacy the next day (5/5/21) to explain the situation. Her symptoms were still persisting and asked for advice. I told her to stay as well hydrated as possible and to take 500-1000 mg of APAP q6-8h and to monitor herself over next couple days for worsening of side effects.
49 2021-05-04 nerve pain, numbness Developed unilateral neuropathic pain in one thigh, progressing to both thighs; posterior arm numbne... Read more
Developed unilateral neuropathic pain in one thigh, progressing to both thighs; posterior arm numbness; skin feels sunburned but no skin findings; lower abdominal burning sensation; This is a spontaneous report from a contactable physician. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 11Jan2021 (Batch/Lot Number: EL3248) as single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, allergies: shellfish. Historical vaccine included 1st dose of BNT162B2 (lot number=59267-1000-1 Lot EJ1685) via intramuscular on left arm on 21Dec2020 for COVID-19 immunization. Concomitant medications included semaglutide (OZEMPIC), atorvastatin, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and enalapril, all taken for an unspecified indication, start and stop date were not reported. Patient developed unilateral neuropathic pain in one thigh, progressing to both thighs. Patient also had posterior arm numbness, skin feels sunburned but no skin findings, also now with lower abdominal burning sensation. The events onset on 22Jan2021. Patient received treatment for the events included prednisone. The events result in doctor or other healthcare professional office/clinic visit. Outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.
49 2021-05-04 pain in extremity Soreness in Vaccination Arm (left Arm). Painful and unable to move the arm; Soreness in Vaccination... Read more
Soreness in Vaccination Arm (left Arm). Painful and unable to move the arm; Soreness in Vaccination Arm (left Arm). Painful and unable to move the arm; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Apr2021 17:00 (Batch/Lot number was not reported) (at age of 49-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks. The patient experienced soreness in vaccination arm (left arm). painful and unable to move the arm on 15Apr2021 23:30. The events did not result in emergency room visit or physician office visit. No treatment was received for the events. There was no COVID prior vaccination or no COVID tested post vaccination. The outcome of events was resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-05-04 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
49 2021-05-05 burning sensation Exactly 24 hours after the vaccine patient developed: lump/rash appears on patient's hand. Within tw... Read more
Exactly 24 hours after the vaccine patient developed: lump/rash appears on patient's hand. Within two hours, both arms covered, back, legs, chest, buttocks. By 7pm on 5/5, patient covered in burning, itching, red rash
49 2021-05-05 discomfort HUGE swelling under arm. About the volume of a softball or larger. Now, 20 days later, I am still ... Read more
HUGE swelling under arm. About the volume of a softball or larger. Now, 20 days later, I am still swollen. It is about 4 inches in diameter and feels about the volume of a racquetball. My underarm is convex, not concave like it should be. I feel a slight pinch or pressure under my arm.
49 2021-05-05 difficulty speaking Pt had an appointment today for her second dose of the COVID-19 vaccine. She received the dose at 0... Read more
Pt had an appointment today for her second dose of the COVID-19 vaccine. She received the dose at 0915 and began experiencing tingling/ swelling lips along with voice changes. Zyrtec 10mg given at this time and adult medical response was called. Pt states that she had a similar response to the first vaccine but that it occurred 45 min after receiving the vaccine. At that time she did not have any medical intervention and did not take any medications at home. A dose of 25mg PO benadryl was given at 10am. No worsening symptoms occurred and pt stated her lips feel slightly improved. Pt observed until 10:30am and discharged to home. Vitals were stable throughout. MD encouraged pt to take an additional 25mg of benadryl at home and if symptoms worsen to seek medical attention. Support provided.
49 2021-05-05 tingling Pt received her vaccine 1438. She started saying she felt funny "hands felt tingling @ 1442" Pt BP... Read more
Pt received her vaccine 1438. She started saying she felt funny "hands felt tingling @ 1442" Pt BP was taken 180/90, RR 20, She appeared red around her neck. Pt was helped to a cot and lied on her back. She was assisted by firefighters. Pt stated she was feeling better. New set of vitals taken at 3PM BP 145/56, HR 98, OxSat 100%. Pt very talkative, smiling and stating she feels much better. She was placed in chair @ 3:05PM tolerated well. If anxiety return when she was at home she was suggested to go to hospital
49 2021-05-06 feeling hot, numbness, flushing Onset of anxious feelings, feeling flushed, and warm feelings on side of left neck and shoulder (acr... Read more
Onset of anxious feelings, feeling flushed, and warm feelings on side of left neck and shoulder (across clavicle), associated with "a little bit of numbness" - same side as vaccination placed - approximately 25 minutes after receiving vaccine. Did take antihypertensive today. Did have significant side effects (dizziness, nausea, vomiting, myalgias) 4 hours post-dose after 1st Covid vaccine, no allergic reaction. No dysphagia, dyspnea, SOB. No rash or swelling of face/mouth/neck. VS @ 11:55: BP146/98, P 70, SpO2: 99%, resp. unlabored. Drank some water, elevated feet, continues observation. VS @ 11:58: BP 155/100, P 77, SpO2 99%. Feeling "a little better". VS @ 12:05: P 77, SpO2 99%. Reports she feels "fine", symptoms resolved. Home at 12:15 with complete symptom resolution. Instructions re: side effect management/self-care, when to call ED given.
49 2021-05-06 migraine Day 1 - fatigue and headache. Day 2 - SEVERE muscle and joint pain, muscle stiffness, migraine, naus... Read more
Day 1 - fatigue and headache. Day 2 - SEVERE muscle and joint pain, muscle stiffness, migraine, nausea, dizziness. Day 3 - SEVERE muscle and joint pain, muscle stiffness, migraine, nausea, dizziness, fever, sweating, chills. Day 4 - Moderate muscle and joint pain, muscle stiffness, nausea, migraine, dizziness, sweating, chills. Day 5 Minimal muscle and joint pain, muscle stiffness, nausea, migraine, dizziness. Day 5 I went to the urgent care because of continued nausea, migraine, and dizziness was preventing me from going to work for 3 days. Before going to the urgent care,I tried taking ibuprofen, naproxen, and acetaminophin and nothing helped the pain. My normal prescription migraine medication didn't help the migraine.
49 2021-05-06 pain in extremity Arm soreness - pain on the sides of the arm where I had the injection that lasted about 24 hours. I ... Read more
Arm soreness - pain on the sides of the arm where I had the injection that lasted about 24 hours. I had loose stools - 29th of April - four times in six hours - 12 noon to 6 pm. Right after midnight, I had the chills - it was the night right after the loose stools. My temperature - 99.1. I had pain in my joints and body aches. Chills lasted two to three hours. I took Tylenol to help with this so I could sleep. In the morning, I was having joint pain. I took another Tylenol and then I got better. I told my PCP - had a virtual visit - and they told to have a COVID test because the day before I was at the COVID clinic giving vaccines. I had a COVID test done on Friday on April 30th. I had runny nose - later in the afternoon (30th). It was just dripping - don't know if it was from seasonal allergies or not. I took some natural allergy medicine (BORON). My runny nose stopped the following day.
49 2021-05-07 slurring Slurred speech; This is a spontaneous report from a contactable consumer (patient). A 49-years-old f... Read more
Slurred speech; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Left on 08Mar2021 12:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history included autoimmune thyroiditis from an unknown date and unknown if ongoing, polycystic ovaries from an unknown date and unknown if ongoing, dairy intolerance (allergy to dairy) from an unknown date and unknown if ongoing, drug hypersensitivity (hydrocodone and Darviset allergy) from an unknown date and unknown if ongoing. The patient's concomitant medications included levotyroxine (levothyroxine), liothionine (liothyronine) and estrogen patch (estrogen). The patient's historical vaccine included the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Feb2021 at 12:45PM on right arm. The patient had not taken any other vaccine in four weeks prior to the first dose of COVID-19 vaccine. The patient did not have COVID prior to COVID vaccination. On 08Mar2021 at 07:00 PM, the patient experienced slurred speech. The patient was not tested for COVID post vaccination. The patient did not receive treatment for the event. The outcome of the event was recovered on an unspecified date 2021. No follow-up attempts are possible.
49 2021-05-07 difficulty speaking, feeling hot At 1408 after receiving her second dose of Pfizer COVID-19 vaccination (Pt. tolerated first dose wit... Read more
At 1408 after receiving her second dose of Pfizer COVID-19 vaccination (Pt. tolerated first dose without incident) Pt. started coughing in the observation waiting area. She appeared red in the face, was very hot and had a raspy voice. Pt. said she felt that her throat was tightening and that was causing her to cough. Writer got Pt. water and made charge RN aware of situation. VS were assessed by HVA at 1410 (HR: 78 bpm; O2 97%; RR 16; BP 134/78) and lung sounds were clear. It was decided to administer 50 mg of Benadryl IM in the R. deltoid at 1411. Pt. stated she normally takes 100 mg of Benadryl PO and 1-2 EPI pen doses when she feels these symptoms at home (Hx of anaphylaxis). Pt. reported little relief and symptoms persisted. EPI pen (0.3 mL) was administered at 1420 in the right lateral thigh. VS reassessed at 1420 (HR: 84; O2 97%; RR 18; BP 128/70) and lung sounds were clear. After EPI her redness subsided but her coughing continued. VS reassessed at 1427 (HR: 84; O2 98; RR 20; BP 138/76). Contacted emergency services and EMS arrived at 1435. Pt. has some relief but stated she thinks she would benefit from another dose of EPI. EMS VS at 1436 BP 106/62 (after 1 dose of EPI). A second dose of the EPI pen (0.3 mL) was given at 1440 in the L. lateral thigh. EMS VS at 1444 was BP 98/41 (after second dose of EPI was given). Pt. transported to ED via ambulance.
49 2021-05-07 pain in extremity Severe pain at site, arm, fingers, and shoulders for the first couple of days; and then itchiness of... Read more
Severe pain at site, arm, fingers, and shoulders for the first couple of days; and then itchiness of legs. April 27- manifestation of rash behind both knees and upper calves. April 30 swelling and edema in both calves. May 1- Swelling to left foot. Symmetrical pain in pressure points. May 2- Severe swelling to both feet, and both calves (left side, which was injection side, was worst on lower extremities). Right eye was almost swollen shut. Left eye was beginning to swell. Severe swelling to face, neck, jaw, and throat, as well as tightness of throat. Anaphylactic reaction. Emergency room visit on the May 2, May 3 was a bad day, filled with pain in joints and pressure points, as well as swelling in feet and calves. Followed up visit to pcp on May 4. Still have rash, itchiness, and swelling of lower extremities. Today, May 8, still experiencing swelling, pressure point pain, and manifestation of rash, as well as it's itchiness.
49 2021-05-07 tenderness 2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clo... Read more
2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clot and other DVT clot found; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female consumer received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot ew0153 as single dose via unknown route at the left arm on 06Apr2021 11:30, at the age of 49 years, for COVID-19 immunization. The patient was not pregnant. Medical history included, in 1996 while on oral contraceptives had a blood clot in left leg. Prescribed Coumadin for year. Went off, bad leg swelling occurred. Prescribed compression stocking. Genetic test discovered Factor V Leiden mutation heterozygous. Since 1996-1998, have had bad swelling in left leg but no further clotting. Last time ultrasound was needed to confirm leg was just bad swelling was approximately 2007. No other clotting since around 1996-1998. Concomitant medications were not reported. On evening 20Apr2021, 2 weeks after vaccine, noticed pain, swelling, tenderness, redness and lump on left leg. Went to doctor on 21Apr2021. Ultrasound performed. Superficial clot and other DVT clot found. Prescribed Xarelto. The outcome of the events was reported as recovering. No covid prior vaccination and the patient was not tested for covid post vaccination.
49 2021-05-08 discomfort 5/7/21 - 28 hours after shot-hives covering arms and legs-intense itch. Allegra taken and gone. 5/8/... Read more
5/7/21 - 28 hours after shot-hives covering arms and legs-intense itch. Allegra taken and gone. 5/8/21 - 6pm stomach and back covered with a sea of red skin. Arms, neck, legs, butt full hives. Intense itch and uncomfortable. Doctor told me to take Zyrtec twice a day for 3 days. Both days have swollen armpit, very uncomfortable.Took Advil.
49 2021-05-09 feeling hot, weakness Started with slight chills during the night Thursday into Friday morning. Then when I got up Friday... Read more
Started with slight chills during the night Thursday into Friday morning. Then when I got up Friday, I had low energy level and a slight headache. I was not able to go to work. As the day progressed (aroun noon) I confirmed a 99.3 fever. No energy at all to get up only wanted to sleep bounced back in forth from being hot to being chilled. Slight headache (about a 3 out of 10) some stiffness in my neck. By 3:45 p.m. no interest in food, very tired, and fever hit 100.1. Took tylenol to help with symptons. Slept off and on and ate what I could, and slept between eating and taking tylenol. By 8:00 p.m. fever was gone. Energy level was still very low. Slept as much as I could and continued eating small amounts often, hydrating with Gatorade. Saturday morning felt like I had energy, but still had some stiffness in my neck and a slight headache (1 out of 10). Took tylenol and returned to work. Worked four hours came home ate and napped again. Stiffness in neck would go away with Tylenol but return. Woke up Sunday morning to only a slightly stiff neck, but that was gone by noon. So as of noon Sunday all symptoms were gone.
49 2021-05-09 feeling hot, numbness mild numbness and warm sensation
49 2021-05-10 weakness, unresponsive to stimuli Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Severe
49 2021-05-10 weakness I have had 4 terrible days after the vaccine that I had to spend in bed. I had horrific severe heada... Read more
I have had 4 terrible days after the vaccine that I had to spend in bed. I had horrific severe headaches at the front of my head and at the back starting in less than 24 hours after the vaccine. On the next day I had a fever added to these headaches. I couldn't open eyes and light hurt my eyes. I had a loss of appetite and huge weakeness. I couldn't walk and had literally to crawl to the bathroom. When I stood up from my bed I almost fainted. After 96 hours after vaccine I still have nausea and headaches that diminished a bit. Fever disappeared only after 96 hours. Still I'm very weak, have nausea and can't really do anything except being in bed. I have never had anything like that in my life after a vaccine. and I'm in perfect health and don't smoke, don't drink any alcohol, doing regular gym and my BMI is normal
49 2021-05-10 feeling hot, pain in extremity The first time highest temperature about 101; Dizzy; felt like someone punched her ten times at inje... Read more
The first time highest temperature about 101; Dizzy; felt like someone punched her ten times at injection site; fatigue; Muscle pain; joint pain had increased; arm pain; felt really hot and sweaty for 2 days; felt really hot and sweaty for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8732, first dose) solution for injection intramuscular in the left arm on 25Mar2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing autoimmune issues, ongoing psoriatic arthropathy, ongoing rheumatoid arthritis, appendix removed a few days before Christmas, joint pain, stops palpations or arrhythmias from mitral valve, replace thyroid hormone after hysterectomy, vitamin d deficiency. Concomitant medications included ongoing acetaminophen for arthralgia, ongoing atenolol for stops palpations or arrhythmias from mitral valve, ongoing levothyroxine for replace thyroid hormone after hysterectomy, ongoing alprazolam for anxiety, and ongoing vitamin D for vitamin D deficiency. Historical vaccine included flu shot and experienced unconscious. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had the first time highest temperature about 101, dizzy, felt like someone punched her ten times at injection site, fatigue, muscle pain, joint pain had increased, arm pain, felt really hot and sweaty for 2 days on 25Mar2021. The patient did not require a visit to ER or Physician Office for the events. Treatment for events fever and punched her ten times at injection site included acetaminophen. The outcome of the events fever, punched her ten times at injection site, fatigue, muscle pain, joint pain had increased, arm pain, felt really hot and sweaty for 2 days was recovered in Mar2021. The outcome of the event dizzy was recovered on 25Mar2021.
49 2021-05-10 numbness, slurring Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet;... Read more
Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; Slurred speech an difficulty swallowing; Slurred speech an difficulty swallowing; Feet felt super heavy and awkward; Significant urination; muscle aches; low-grade fever; very tired; Slight headache; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; blood sugar plummeted; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 15:45 (Batch/Lot Number: CR8735) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Type 1 diabetes, Some allergy medications like zyrtec, topamax, Nortriptyline, allergic asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included insulin lispro (HUMALOG); bisoprolol (BISOPROLOL); fexofenadine hydrochloride (ALLEGRA). Historical Vaccine included product=COVID 19, brand=Pfizer, lot number=EP7533, administration date: 04Apr2021, administration time =04:00 PM, dose number =1, vaccine location =Left arm for covid-19 Immunization. Reported Event: About 3 hrs after 2nd dose, lower back pain for 20 minutes followed by numbness in tongue, throat, lips, cheeks, hands, feet, slurred speech an difficulty swallowing. Extreme difficulty thinking. Feet felt super heavy and awkward, like they were bricks. She was a type 1 diabetic and her blood sugar plummeted. She had to stop her basal delivery for an hour, then she halved her basal rate for several hours. After laying down for a few hours, symptoms improved, but worsened when standing. Significant urination every 40 - 60 mins for several hours. In the morning, muscle aches throughout body, low-grade fever, very tired. Slight headache. Adverse event start date: 25Apr2021, Adverse event start time: 06: 30 PM, No treatment for AE. Lab data included blood sugar: plummeted on 25Apr2021. The event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-05-10 muscle spasms Post-menopausal menstruation: I have been in menopause since December 2019, which is to say that I h... Read more
Post-menopausal menstruation: I have been in menopause since December 2019, which is to say that I have not had a menstrual period in almost a year and a half. However, some time after receiving my first dose of the Pfizer COVID19 vaccine , I experienced familiar symptoms of ovulation and PMS (tender breasts, vaginal discharge, and cramping). Then on May 8, 2021 (approx 2 weeks after receiving my second dose of the vaccine), I began menstruating heavily. Very heavily. On May 9 and 10, I continued to menstruate heavily. And, at the time of this writing (May 11), I continue to menstruate.
49 2021-05-10 muscle spasms May 9 have not had a period since December 2020 and was always two days May 10 YES Headache Fatigu... Read more
May 9 have not had a period since December 2020 and was always two days May 10 YES Headache Fatigue or tiredness Nausea & feet cramp and no longer get periods since before 2021 and have had twice blood flow :(. Nausea and tiredness have kept me from being able to do my usual workout or other activities. NO Redness/Swelling Muscle pain/Pain Chills/ Fever
49 2021-05-10 pain in extremity fever 103.5; Vomiting; exhaustion; headache; severe chills; arm ache; This is a spontaneous report f... Read more
fever 103.5; Vomiting; exhaustion; headache; severe chills; arm ache; This is a spontaneous report from a non-contactable consumer. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 06Apr2021 10:30 (Batch/Lot Number: EP6955) as SINGLE DOSE (at the age of 49 years) for covid-19 immunisation. The patient had the first dose of BNT162 lot number EN6208 for Covid-19 immunization on 16Mar2021 10:30 in right arm at the age of 49 years. Medical history included drug hypersensitivity from an unknown date (known allergies: Sulfa), drug hypersensitivity from an unknown date (known allergies: Penicillin). The patient was not pregnant at the time of the vaccination. Patient did not have Covid-19 prior to vaccination. The patient's concomitant medications were not reported. No other vaccine taken in four weeks. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity (known allergies: Cipro). The patient experienced fever 103.5 on 06Apr2021 23:00 with outcome of recovering, vomiting on 06Apr2021 23:00 with outcome of recovering, exhaustion on 06Apr2021 23:00 with outcome of recovering, headache on 06Apr2021 23:00 with outcome of recovering, severe chills on 06Apr2021 23:00 with outcome of recovering, arm ache on 06Apr2021 23:00 with outcome of recovering. The patient was not Covid-19 tested post vaccination. No treatment was required. The patient underwent lab tests and procedures which included body temperature: 103.5 on 06Apr2021. No follow-up attempts are possible. No further Information expected.
49 2021-05-10 pain in extremity Sore arms; Some heart palpitations; Very sensitive to light one side of head; chills; felt like she ... Read more
Sore arms; Some heart palpitations; Very sensitive to light one side of head; chills; felt like she has been hit by a truck. It liked knock her out.; Headache on one side of head/ serious headache; Feel a lot of pressure on one side of head; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL9261, expiration date unknown) on 22Mar2021 at age of 49-year-old via an unspecified route of administration on the left arm at single dose for COVID-19 immunisation. Patient previously received 1st dose of BNT162B2 (Lot number: EL9266) via an unspecified route of administration on the left arm on 25Feb2021 at age of 49-year-old at a school for COVID-19 immunisation. Medical history and concomitant medication was reported as no. The patient stated she was not sure if someone else has been reported it. She was having headache. She was having headache on one side of head, also one week has been down. She was having serious headache and she just wanted to know if this was something that has been reported. Patient stated after the vaccine, she was having sore arms, noticed some heart palpitations, also didn't feel any nausea, chills and pulse (pending clarification). But she did feel like she has been hit by a truck. It liked knock her out. She was out for like two days. She had recently been having headache on one side of head. When she bend down, she felt a lot of pressure on one side of head and also light. She was very sensitive to light one side of head. Patient was receiving ongoing Tylenol 500mg, 2 tablet, twice a day as treatment. Onset date of "headache on one side of head/ serious headache" and "feel a lot of pressure on one side of head" was 04Apr2021. Outcome of event "headache on one side of head/ serious headache" and "feel a lot of pressure on one side of head" was not recovered, of the other events was unknown. No follow-up attempts are needed. No further information is expected.
49 2021-05-10 pain in extremity I received the shot around 9:18am on Friday May 7th - felt fine and then at 8:35pm I experienced fev... Read more
I received the shot around 9:18am on Friday May 7th - felt fine and then at 8:35pm I experienced fever, chills, stabbing pain in my arm, neck, legs, back, rash on my face/neck-itching, nose drainage and then I had difficulty breathing. I had shortness of breath and then I would cough. The coughing continued and was continuous. I would take a deep breath and then I would have a coughing fit. I couldn't sleep Friday night at all. These symptoms lasted until Sunday morning. The difficulty in breathing subsided Saturday afternoon but the coughing continued. On Sunday morning I woke up and my left arm (injection site) and arm pit were swollen and sore. The chills and fever subsided. The other muscle aches disappeared. It is Tuesday and slowly the coughing has lessened but it still present along with feeling like having a tight chest. Nose is still having drainage. The arm pit and injection site being swollen has gone down but is still present. The rash is starting to fade.
49 2021-05-10 tingling Patient complained of dizziness and hands tingling. B/P- 150/94, P-101, R-22, O2 sat-99% on room ai... Read more
Patient complained of dizziness and hands tingling. B/P- 150/94, P-101, R-22, O2 sat-99% on room air. Denies any other signs and symptoms. Patient left with daughter.
49 2021-05-10 trigeminal neuralgia Trigeminal neuralgia; This is a spontaneous report from a contactable consumer (patient). A 49-year-... Read more
Trigeminal neuralgia; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: er8729), via an unspecified route of administration, administered in right arm on 11Apr2021 17:30 as single dose for COVID-19 immunisation. Medical history included known allergies to shellfish, PCN (Penicillin), and iodine from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. There were no concomitant medications. The patient previously took prochlorperazine edisylate (COMPAZINE) and experienced drug allergy. On 12Apr2021, the patient has had very bad nerve issues in left side of face/ eye. She saw an eye specialist and a primary doctor and was diagnosed with Trigeminal neuralgia. The event resulted in a doctor or healthcare professional office/clinic visit. The patient has not recovered from the event.
49 2021-05-11 feeling cold, weakness, pain in extremity was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really h... Read more
was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really hot and dry; slight fogginess; achiness; I tested positive for COVID; Restless body; Nausea; Weakness; Fast heartbeat; Headache; Chills; Muscle pain; Feeling unwell; high fever couldnt shake it at all; got congested/ Stuffy nose; facing joint ache; extremely tired/ Tiredness; Pain in arm/ whole hand just felt achy; Heart hurt when laying on side; Dizziness/ lightheadedness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 15:00 (Batch/Lot Number: EW0164) (at the age of 49 years old) at 1st dose, single for COVID-19 immunisation. Medical history included asthma and hypersensitivity (allergies). Concomitant medications included montelukast sodium (SINGULAIR) taken for hypersensitivity; formoterol fumarate, mometasone furoate (DULERA) taken for asthma; beclometasone dipropionate (QVAR); and levosalbutamol hydrochloride (XOPENEX). On unspecified date in Apr2021, she got pretty sick and swollen lymph nodes. On 23Apr2021, the patient experienced heart hurt when laying on side, high fever couldn't shake it at all, extremely tired/tiredness, headache, chills, muscle pain, feeling unwell, joint pain/ facing joint ache, dizziness/lightheadedness, fast heartbeat, pain in arm and got congested/ stuffy nose. On 24Apr2021, the patient experienced nausea and weakness. On 25Apr2021, the patient experienced restless body, her body also got extremely restless like she had restlessness lesions on whole body. On 26Apr2021, the patient tested positive for COVID-19. On unspecified date, the patient experienced chest pain, she wakes up freezing and her eyes felt really hot and dry and was exhausted, whole hand just felt super achy, slight fogginess and achiness. The patient had vaccination on Friday. On Friday night, she started not feeling well and then was like full blown all the Saturday all the Sunday (as reported). The patient got vaccination last Friday and had a severe reaction to the vaccination. She was extremely upset about it because now she tested positive for COVID. She was not really showing any symptoms and whatsoever before of any COVID like symptoms. Allergy was bothering her but no fever, no chills, no tiredness, no achiness and no nothing. She was nervous because she did realize that it wasn't FDA approved and now she was suffering positive, she started feeling a little better but still tested positive. It was reported that the event started at the time of report, 26Apr2021. The patient had a severe reaction. She had every symptom except that her arm didn't swell. She didn't have any rash in her body. She got pretty sick. She had a high fever couldn't shake it at all, got congested, facing joint ache and extremely tired. Her body also got extremely restless like she had restlessness lesions on whole body she couldn't lay down. The patient reported that it was hurting her so bad and she had to keep moving like she couldn't relax fall free. She had a severe reaction and doctor said she could have COVID knowing it and then got a shot and then came out full blown. The patient stated she was taking Tylenol (50mg, Not clarified), Tylenol Cold and sinus (325mg) for like a flu and Motrin (500mg). She had some time to shake the achiness and the fever was just coming back. She took Tylenol to help rid of fever and achiness, it didn't help and then she tried Tylenol cold and flu that help the little bit then she tried Motrin the Motrin help more with achiness but not hundred percent. The outcome of the events heart hurt when laying on side and fast heartbeat, both recovered on 26Apr2021; events high fever, tiredness, chills, muscle pain, feeling unwell, swollen lymph nodes and dizziness were recovering; events nausea, restless body and stuffy nose were not recovered; and unknown outcome for the other events. No follow-up attempts are needed. No further information is expected.
49 2021-05-11 feeling hot, numbness, tingling Approx 10 to 12 days after doses 1 and 2 , I developed numbness and tingling in bilateral hands and ... Read more
Approx 10 to 12 days after doses 1 and 2 , I developed numbness and tingling in bilateral hands and feet.I also experienced sensation of warmth and coolness in the back of my hands and calves. As of 05/12/21, I continue to experience the symptoms .As I report this the symptoms have been almost constant for the past 3 days. Ironically two of my cousins and one aunt gave experienced this also with the Pfizer vaccine.
49 2021-05-11 migraine, tremor, weakness Headaches, migraines, muscle pain (everything hurts to the touch), weakness (especially in limbs, bu... Read more
Headaches, migraines, muscle pain (everything hurts to the touch), weakness (especially in limbs, but also overall), low stamina, fatigue, insomnia, nausea, dizziness, a feeling of internal vibration, ringing in the ears, brain fog, sore lymph nodes (underarm), GI issues, abnormal temperature regulation (shivering one minute, sweating the next), feeling really unwell. It's been 4.5 weeks and these reactions have not been transitory, but are, in fact, ongoing and nearly constant. This shot has had a significant negative impact on my quality of life and my ability to function and perform even just minor activities of daily living.
49 2021-05-11 pain in extremity, cold sweat, numbness, tremor, tingling, numbness and pain in extremities First I got my 1st shot Sunday morning I sat in the observation, and for a brief period I got dizzy,... Read more
First I got my 1st shot Sunday morning I sat in the observation, and for a brief period I got dizzy, and nauseated. It was brief. Day two sore arm of course, and tired felt like flu symptoms Day 3 extremely tired, and couldn't keep my head up I was so lethargic. Felt like the Flu was coming on went to bed after work Thursday, Fri, and Sat my head was still feeling like I had a head cold. Fatigued still Sunday I was in dream state when I jolted from a spinning feeling in my sleep. I opened my eyes and I couldn't even function. I couldn't get out of bed nor move I was completely spinning. I tried to make it to the bathroom and threw up bile. Took a anti nausea pill Zofran, and didn't work. Nothing was working. I fell asleep and woke up just constantly dry heaving. The vertigo was so bad I felt faint It was then at the point I was passing out when we called 911. I couldn't move I was perspiring, and couldn't keep liquids down. I was shaking, clamy, and my body turned numb. Thought I was having a stroke. In the ambulance narapathy started up, and down my arms and hands,, and my fingers locked up. Chest was on fireI, and my whole body tingled with fighting off whatever it was.. The hospital IV me with Zofran several times. Antivert and Ativan. EkG fine CT head Brain CT head neck. Ears were fine. No infection in ears. Blood Glucose was high 182 CO2 was slightly low 22 Lymphocytes low 21.6 low Neutrophils Absolute 7.7 high Nothing else to do but send me home to follow up with ENT and Nuero to make appts to follow up. I scheduled my primary qs well to look me over.
49 2021-05-11 pain in extremity pts left arm was sore and had some fatigue that disappeared the next day after getting the vax but a... Read more
pts left arm was sore and had some fatigue that disappeared the next day after getting the vax but about a week later she had developed a scaly rash on both forearms that was red, inflamed, and extremely itchy. The rash spread to her wrist, cheek, chin, left ear, and both thighs. The rash has blisters with liquid in them that burst when she touches them. she has not treated them with any meds at this point Pt will contact PCP for medical advice.
49 2021-05-11 tenderness Heavy vaginal bleeding with clots, cramping in uterus and tenderness in this area prior to onset of ... Read more
Heavy vaginal bleeding with clots, cramping in uterus and tenderness in this area prior to onset of bleeding. Vaginal bleeding lasted for 6 days. Please note that this was not like a regular menstrual period and I was not due for my period. I also bled after my first Pfizer vaccine but it was not alarmingly heavy like it was after this second dose. After this second vaccine dose, I was fatigued during the bleeding and after. The fatigue was resolved two weeks after I received the second vaccine. One other strange side effect was that three days after I received the second vaccine my left hand was slow to respond when I needed to type on the computer. This lasted for several days.
49 2021-05-12 burning sensation, tenderness I developed a herpes sore on my top lip 2 weeks post injection for both doses. Treated topically at ... Read more
I developed a herpes sore on my top lip 2 weeks post injection for both doses. Treated topically at home with OTC Abreva cream, resolved about 1 week later. I also experienced oral discomfort on my hard palate and tongue about 24-48 following both injections. It was similar to a chemo side effect but not as severe, tenderness, kind of raw/burning sensation. Resolved on its own after several days
49 2021-05-12 muscle spasms Severe intestinal pain, cramping, stabbing pain, diarrhea
49 2021-05-12 nerve pain, numbness swollen lymph nodes left arm (resolved 6 weeks later), nerve pain left arm (resolved), headache (res... Read more
swollen lymph nodes left arm (resolved 6 weeks later), nerve pain left arm (resolved), headache (resolved), tingling in lips (resolved), numbness left side of face (continuing)
49 2021-05-12 night sweats Approximately 56 hours after 2nd dose i began to have night sweats, waking up approximately every 2 ... Read more
Approximately 56 hours after 2nd dose i began to have night sweats, waking up approximately every 2 -3 hours. 5 weeks post 2nd vaccine, these night sweats are continuing.
49 2021-05-12 pain in extremity extreme fatigue; malaise/feel sick; the bottoms of my feet hurt so it's hard to walk; the bottoms of... Read more
extreme fatigue; malaise/feel sick; the bottoms of my feet hurt so it's hard to walk; the bottoms of my feet hurt so it's hard to walk; This is a spontaneous report from a contactable other hcp (Patient). A 49-year-old female patient received bnt162b2 (Pfizer), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 13:15 (Lot Number: er8733) as single dose for covid-19 immunisation at the age of 49-year-old. The patient was not pregnant at time of vaccination. Medical history included herniated disc (l5-s1) and back pain from an unknown date. No known allergies. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced extreme fatigue and malaise/feel sick, the bottoms of feet hurt so it's hard to walk on 28Mar2021 with outcome of not recovered. The events were considered serious as disability. The events resulted in Doctor or other healthcare professional office/clinic visit. The clinical course was reported as follows: I am having extreme fatigue and malaise. Prior to receiving the vaccine I had NO health issue other than back pain, but now I have extreme fatigue, the bottoms of my feet hurt so it's hard to walk, (and I'm fit) and I feel sick ALL OF THE TIME. Follow up needed, further information has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
49 2021-05-13 weakness I had the shot around 12noon - waited the 1/2 hour with no issues. So was released and came home. ... Read more
I had the shot around 12noon - waited the 1/2 hour with no issues. So was released and came home. About 1:30/2pm, suddenly felt short of breath (couldn't catch or take deep breath), increase of heart rate & dizzy, and when I tried to stand my legs gave way. Felt like I would pass out. I was short of breath, dizzy, dehydrated, strange feeling in brain and extremely weak for about 2 1/2-3 hours. Then it passed without medication/Epi-Pen. After that, I had typical side effects (chills, exhaustion, muscle pain - particularly at old injury points, dull headache).
49 2021-05-13 numbness Pt reported dizziness, unilateral left side face numbness from mandible to ear with "some pain" in l... Read more
Pt reported dizziness, unilateral left side face numbness from mandible to ear with "some pain" in left ear and pain in left shoulder/trap area. Pt ambulated selft to Med Obs 1 escorted by reaction nurse. No tachycardia, no tachypnea, no swelling noted and pt reports no SOB. Resting VS WNL @ 0818. Pt reported feeling better at 0830 after education and relaxation techniques. ORTHO VS 0905 Lying BP 115/73 HR66 RR 18 SpO2 98% RA 0906 Sitting BP 111/74 HR 63 RR 18 SpO2 99% RA 0907 Standing BP 114/80 HR 77 RR 18-20 SpO2 98% RA Symptoms reported to be resolving. pt reported no dizziness with ambulation in Med Obs 1 at 0907 and escorted to exit to ensure pt safety leaving site at 0912
49 2021-05-13 numbness After vaccine was administered , pt. reported facial numbness, headache, nauseas, Pt. was assessed... Read more
After vaccine was administered , pt. reported facial numbness, headache, nauseas, Pt. was assessed by pcp and vital signs were taken every 15 minutes, Pt. was sent home with ER precautions An appointment was given for next day for reassessment
49 2021-05-13 tremor started at 11:59 05/10/2021 after receiving the vaccine & lasted three days - uncontrollable severe... Read more
started at 11:59 05/10/2021 after receiving the vaccine & lasted three days - uncontrollable severe shaking with chills lasting about 3-4 hours, fever rollercoaster 101 - 103.7 , muscle and joint pain where you could barely move, continual sweating and the inability to regulate body temperature, no appetite, headache with sinus pain and pressure . On Thursday - visual field would look like translucent waves at one time. Currently on day 4 - my fever is gone, but my body is having difficulty regulating warm & cold, still have a headache with sinus pain and pressure and mild/moderate muscle aches and pains. Vaccine site is still sore, but now starting to itch occasionally.
49 2021-05-14 numbness, mild one side paralysis Four weeks after send dose of Pfizer experience Stroke-like symptoms such as numbness on left face,... Read more
Four weeks after send dose of Pfizer experience Stroke-like symptoms such as numbness on left face, arm and leg; confusing head; sharpness of skin sense declined. Hospital ED, did multiple tests including MRI.
49 2021-05-14 numbness, restless legs syndrome After three days of the cycle completed, my legs were very weak. By the next week both arms started ... Read more
After three days of the cycle completed, my legs were very weak. By the next week both arms started to hurt so bad specially in the middle of the nite, 2am, 3am and 5pm. Lastly for the past two weeks my hands were getting numbed and having restless legs syndrome. Also my past injuries have been hurting me a lot. So far it has been a month and I got worse, that is why I decided to go to the doctor this past Thursday , May 13. She has prescribed me some steroids and barbiturates in order to sleep because I can?t sleep during the night.
49 2021-05-14 tingling Got diagnosed with mild stroke after a high blood pressure crisis; Got diagnosed with mild stroke af... Read more
Got diagnosed with mild stroke after a high blood pressure crisis; Got diagnosed with mild stroke after a high blood pressure crisis; blurry vision on the left eye; Pins and needles feelings in left body side; headache; memory loss; This is a spontaneous report from a contactable consumer (reporting for herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Mar2021 at 10:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included high blood pressure, and asthma. The patient's concomitant medications were not reported. On 14Mar2021, the patient was diagnosed with mild stroke after a high blood pressure crisis and the symptoms showed days after the vaccine such as blurry vision on the left eye, pins and needles feeling in left body side, headache and memory loss. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of the events was unknown. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in emergency room/department or urgent care and was admitted in the hospital for 2 day. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
49 2021-05-14 paralysis, numbness Severe muscle soreness (paralyzing); Severe muscle soreness (paralyzing); soreness in tissue and bon... Read more
Severe muscle soreness (paralyzing); Severe muscle soreness (paralyzing); soreness in tissue and bones; soreness in tissue and bones; unable to walk straight; numbness in hands, arms, and feet.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 11:00 (Batch/Lot Number: EW0162) at the age of 49 years, as 0.3 ml single for covid-19 immunisation. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot: EN6207, on 25Mar2021 at 11:00 AM at 0.3 ml single in left arm. Medical history included calcium deposits and mitral valve prolapse, from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 15Apr2021 at 18:00 the patient experienced severe muscle soreness (paralyzing), soreness in tissue and bones, unable to walk straight, numbness in hands, arms, and feet (severe symptoms as such for 4 days). The outcome of the events was resolving.
49 2021-05-16 weakness patient felt palpitations noted and weakness with pt having some juice and crackers and feeling bet... Read more
patient felt palpitations noted and weakness with pt having some juice and crackers and feeling better as well. Pt was able to drive out as well with vitals sat 98% HR 89
49 2021-05-17 weakness Dizziness; Nausea/gets lot of nauseous; Weakness/she feels like weak; Vomiting; Her muscle still sor... Read more
Dizziness; Nausea/gets lot of nauseous; Weakness/she feels like weak; Vomiting; Her muscle still sore; fever; Feeling unwell; This is a spontaneous report from a contactable consumer who reported for her/his mother. A 49-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arrm on 30Apr2021 17:30 (Batch/Lot number was not reported) as single dose (at 49 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 30Apr2021, the patient experienced dizziness, nausea/gets lot of nauseous, weakness/she feels like weak, vomiting, her muscle still sore, fever, feeling unwell. Dizziness, nausea, weakness, vomiting, myalgia were worsened. The outcome of all events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-05-17 burning sensation This reaction happened after my second COVID vaccination from PZIFER--not almost immediately the sam... Read more
This reaction happened after my second COVID vaccination from PZIFER--not almost immediately the same evening post vaccination I had a mild rash on my neck which resolved immediately and I had some flu like symptoms. But that isn't the reaction. About 9 days after the inoculation, My arm was developing a raised oozing rash which burned--this progressively became worse over the course of several days,, at which point my arm looked like I had a crusted fungal infection (very painful) or necrotizing bacteria--I did see an MD and a dermatologist looked at my arm via pictures--(still have them) It was deemed a vaccine reaction and I was prescribed "Fluocinide" ointment. Eventually my arm healed but it took a couple more weeks,. It was painful and extremely unattractive at the time of reaction.
49 2021-05-17 feeling hot, pain in extremity Lymph node swelling/ having lymph nodes on the left side of the back of her neck that were swollen; ... Read more
Lymph node swelling/ having lymph nodes on the left side of the back of her neck that were swollen; Fever; She felt really hot and sweaty for 2 days.; She felt really hot and sweaty for 2 days.; Muscle pain; She felt the pain in knees, hips, wrist, and elbows with second dose/Joint pain; She felt disabled like she can't move; Crazy fatigue; Joint pain had increased; Arm pain; Feeling like someone had punched her 10 times/ felt like someone punched her ten times at injection site; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 13:30 (Batch/Lot Number: EL9262) as 2nd dose, single for covid-19 immunisation. Medical history included autoimmune disorder (ongoing), psoriatic arthropathy (ongoing), rheumatoid arthritis (ongoing), abdominal operation (appendix removed), Joint pain, anxiety, vitamin D deficiency, palpations, arrhythmias, hysterectomy and hypersensitivity (she has lots of allergies. anaphylaxis was a concern for her). Family history included her two sisters and mom had GI symptoms after the Covid19 vaccine. One of the two sisters works in healthcare. Concomitant medications included paracetamol (ACETAMINOPHEN) ongoing since unknown years at a dose of one 500 mg, ranges from 2 to 3 a day, liquid gel for arthralgia, hypersensitivity (she took it as she had to); atenolol tablet ongoing since at least 20 years at a dose of 100 mg oral, two times daily for palpitations, arrhythmia (she had lots of allergies and when she finds something that works, she leaves it alone); levothyroxine tablet ongoing since 10-15 years at a dose of 0.05 mg oral once daily for thyroid hormone replacement therapy; alprazolam tablet ongoing since at least 20 years at a dose of 1 mg oral 3-4 times a day for anxiety; vitamin D Nos ongoing since an unknown date at a dose of 50 mcg, softgel, once a day for vitamin d deficiency (If the deficiency goes lower her doctor would have her take two but right now she takes one). No other vaccine in four weeks. The patient previously took first dose of bnt162b2 in left arm (Lot number:ER8732) on 25Mar2021 at 14:30 for covid-19 immunisation and had experienced dizziness, vaccination site pain, hyperpyrexia, fatigue, pyrexia, myalgia, condition aggravated, pain in extremity, hyperhidrosis, feeling hot and took flu shot made her unconscious. It was reported that, patient was reporting on herself and had a question. She got the first vaccine on 25MAR2021. She had the second dose on 15APR2021. She asked the doctor about it because she does have several autoimmune issues. She mentioned she had gotten a flu shot in the past but the flu shot made her unconscious. It had no after effect, and it did not do anything. She had not received the flu shot in the last 20 years and had not gotten the flu either. For the flu shot she didn't have the Lot, NDC or EXP. At that time, she was working in healthcare and made everyone do it. It was a fluke and no after-effects. She also mentioned she had lots of allergies. Anaphylaxis was a concern for her. With the first shot, she couldn't describe it, but first 10 to 15 seconds less than a minute started feeling dizzy but not really, states it was like when you first wake up from surgery where you are confused. It was an odd sensation. Then it went away. She didn't think much about it. She didn't even feel the needle prick then half hour later it felt like someone punched her 10 times, which lasted for two or three days. She decided to sit extra time in the waiting room area. She later confirmed later that this was regarding the Pfizer Covid Vaccine. She mentioned that she takes Tylenol on a daily basis but did not take it the day she got the vaccine. She went on to explain that she had a list of what to expect but the first dose it wasn't that bad. Within 8 hours of both vaccines experienced crazy fatigue and was so tired. She has joint pain normally and was in a flare due to psoriatic and rheumatoid arthritis but after the vaccines the joint pain had increased. After a couple of days, it went back to how her pain normally was. Her main issue was with the second vaccine. The second shot on 15APR2021 did expect it to be worst. Dizzy: It went away. It was less than a minute and then it was gone. It happened while she was sitting in the seat. It was so strong and then it went away in a minute, it was gone. She felt like someone punched her ten times at the injection site: occurred with both doses, the first time it occurred starting 25MAR2021 She didn't even feel the needle prick, the injection itself did not hurt, then it felt like someone punched her hard 10 times. This started 20 to 30 minutes after getting the vaccine. When she got home no redness or really even swelling. Later confirmed no swelling. She had arm pain that lasted for 2-3 days and then it went away. The same thing occurred with the second dose on 15APR2021. Then it resolved on its own. She used icepack as a treatment. it did not kill the pain but made it more tolerable. She was just more sensitive. She confirmed that she recovered completely from the feeling like someone had punched her 10 times from both the first and second dose. Fatigue: It started 8 hours after vaccine on both 25Mar2021 and 15Apr2021. She thought she was home free. It was weird. She also mentioned with fatigue she started having a fever, muscle pain, and horrible joint pain all at the same time. They lasted 2-3 days and then she recovered completely. Fever: Started 25MAR2021 after the first vaccine and then started again on 15 APR 2021 after the second vaccine. She felt really hot and sweaty for 2 days. She said she does not feel get fevers very often. She had it 8 hours after both injections she wasn't sure why it took 8 hours. The first-time highest temperature about 101. Both times she took Tylenol every 6 hours for two days and as soon as the Tylenol wore off the fever would come back but the temperature would be lower. She confirmed she recovered completely after both occurrences. Caller initially stated she was taking Tylenol and then later clarified she was taking CVS brand acetaminophen. She mentioned she takes this one because she had a lot of allergies and cannot take the regular Tylenol brand due to the fillers in it, Tylenol bothers her. Caller referred to CVS acetaminophen as Tylenol throughout the report and then clarified at the end. Tylenol clarified as CVS brand acetaminophen. Did not had lot number, expiration, NDC. The lot number and expiration date are rubbed off the bottle and she cannot read them, there is a black smear where it says lot/exp. Muscle pain: Hit all at once and lasted 2 days for both vaccine doses. She recovered completely from both occurrences. and started within 8 hours for both doses. Joint pain: It started within the same time. Within 8 hours of both doses. She had joint pain every day but it amplified after vaccine doses. She felt disabled like she can't move. There was a difference. First time mostly was in her knees and hips. The second time it seemed to last longer, it aggravated the flare already there. She felt the pain in knees, hips, wrist, and elbows with second dose. States the wrist joint pain was really bad and she sometimes gets that with her rheumatoid arthritis but she was not having pain in arms, in her wrists and elbows before the injection. She has pain now but its the normal pain that she had felt prior to the injection. Lymph Node swelling: on saturday the 17APR2021 noticed her lymph nodes were swelling. She had a mammogram appointment. It was located under her left armpit. She called your doctor next day on the 18th because it was getting more painful. She was also having lymph nodes on the left side of the back of her neck that were swollen. That was part of the reason that she was calling because she wanted to see if that was normal. The lymph nodes swelling are all still there and they hurt. When probed for outcome caller did not clearly provide. She just mentioned that she was aware that it could happen under the armpit and figured that it would go away. But then she got one on the back of her neck which is also on the left side. She knows overtime that side effects have been added to our list. The doctors said if its persisting longer to call back and come in. Asked if it was normal. She did not have a cold or anything that would be causing it. she thought that the shingles vaccine was due next for her since she would turn 50, but she did not think she would get that. Treatment was received for events. The outcome of event lymphadenopathy was not recovered, whereas recovered for all other events. Description of Product Complaint: Description of complaint: While reporting on the Covid 19 vaccine caller mentioned details on other products. She first mentioned details about the flu shot. She mentioned she has gotten a flu shot in the past, but the flu shot made her unconscious. It had no after effect. She has not received the flu shot in the last 20 years and has not gotten the flu either. For the flu shot she doesn't have the Lot #, NDC or EXP. She also mentioned details about Tylenol clarified as CVS brand acetaminophen. She took Tylenol every 6 hours and as soon as the Tylenol wore off the fever would come back but the temperature would be lower. Did not have lot number, expiration, NDC. The lot number and expiration date are rubbed off the bottle and she cannot read them, there is a black smear where it says lot/exp. She mentioned she taken this one because she has a lot of allergies and cannot take the regular Tylenol brand due to the fillers in it, it bothers her. No follow-up attempts are needed. No further information is expected.
49 2021-05-17 pain in extremity Achy feeling in back & legs Tiredness Small headache
49 2021-05-18 feeling hot Face got very red; Face got very red, hot; Face got slightly swollen; Face got very red, hot and spl... Read more
Face got very red; Face got very red, hot; Face got slightly swollen; Face got very red, hot and splotchy; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 05Mar2021 at 09:30 (at the age of 49-years-old), as a first single dose for COVID-19 immunisation. The patient's medical history included asthma. The patient had previously experienced allergy when receiving Zithromax (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Mar2021 at 09:45, the patient's face got very red, hot and splotchy and was slightly swollen. The patient did not receive any treatment for the adverse events. The clinical outcome of face got very red, hot and splotchy and slightly swollen was recovered. No follow-up attempts are needed. No further information is expected.
49 2021-05-19 feeling hot, tingling, numbness and pain in extremities pins and needles in her extremities, both hands and both feet; warm feeling in torso; fever/running ... Read more
pins and needles in her extremities, both hands and both feet; warm feeling in torso; fever/running a 101-102 fever; tired; neuropathy in all her extremities; This is a spontaneous report from a contactable consumer (patient's son). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 16Feb2021 15:00 (Batch/Lot number was not reported) (at the age of 49-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included hashimoto's disease from 2019 to an unknown date. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknow date for covid-19 immunisation. The consumer stated his mother has been experiencing neuropathy in all her extremities since over a week ago when vaccinated on an unknown date in Feb2021, and it's getting worst. The consumer added all doctors are saying it's due to the vaccine. The consumer explained when he took her to the urgent care, they mentioned her reaction is actually pretty common post vaccination. On 16Feb2021, about 2 hours after getting the vaccine she was very tired. On 17Feb2021, patient experienced fever/ running a 101-102 fever. On 20Feb2021, she was feeling worsening pins and needles in her extremities, both hands and feet and it is freaking and warm feeling in torso. The outcome of the event fever was recovered on 18Feb2021, pins and needles in her extremities both hands and both feet was not recovered, and remaining events was unknown. Information on the lot/batch number has been requested.
49 2021-05-19 feeling hot Patient received her first dose Pfizer (LOT#: EW0182 EXP: 8/2021) at 1046 on 5/14/21. Patient alerte... Read more
Patient received her first dose Pfizer (LOT#: EW0182 EXP: 8/2021) at 1046 on 5/14/21. Patient alerted EMT . Patient stated that she felt hot around her neck area and moved to ears and shoulder region. Patient stated she also felt itchiness around her head area. EMT took patients vital signs at 1110. BP: 128/84, pulse: 81, O2: 97%. Patient was given water and asked to stay an extra 30 minutes for further observation. EMT reassessed and re-took vital signs at 1120. BP: 124/82, pulse: 84, O2: 99%. Patient stated she was feeling better. EMT reassessed and retook final vitals for patient at 1130. BP: 118/78, pulse: 82, O2: 99%. Patient stated she felt no symptoms and felt fine to leave. Patient completed observation time. PHN educated patient on worsening signs and symptoms of vaccine and when to call EMS or go to emergency room or urgent care. Patient verbalized understanding of education. Patient left vaccination site at 1138 unassisted and with a steady gait.
49 2021-05-19 slow speech, slurring Patient received Pfizer Covid vaccine dose #1 at approximately 1225. Patient then went to observatio... Read more
Patient received Pfizer Covid vaccine dose #1 at approximately 1225. Patient then went to observation area. Patient was noted to be resting her head and closing her eyes and occasionally checking the time on her watch. At 1240, observation RN went over to check on her and the patient stated that she felt tired, dizzy and was speaking slowly. 1243: BP 132/80, blood sugar 123, O2- 96 % on RA and HR 78. Patient noted to have slower speech along with slurring of her words. Patient remains A&Ox4. RN who gave vaccination called over to evaluate nurse and confirmed that patient was not speaking or acting like this at the time of vaccine. 1250: EMS called to take patient to hospital. 1255: Patient lung sounds clear and moving good air. Stroke assessment negative. 1300: Patient reports feeling ?loopy?. Patient?s husband notified that she is going to Emergency Room. She states that she feels like she is going to get sick, dry heaving noted. Patient reports that her medical history includes MS, functional movement disorder, hypothyroidism and depression. She reports her home medications as synthroid, Klonopin, celexa and copaxone. EMS arrived at 1305 and loaded patient up onto stretcher and left with patient.
49 2021-05-19 speech disorder Difficulty breathing, fast heart rate, hard time speaking within 17 minutes of vaccination. Was giv... Read more
Difficulty breathing, fast heart rate, hard time speaking within 17 minutes of vaccination. Was given oxygen at location and epi injection during EMT transport to Hospital ER. was given steroids, benadryl. After discharged from ER, continued to have headaches, nausea, site soreness for 1 week.
49 2021-05-20 weakness Fever, headache, nausea, tired/weak
49 2021-05-20 tingling By 10:50 am, my tongue was numb, I couldn't hold a pencil, my right hand and arm had pins and needle... Read more
By 10:50 am, my tongue was numb, I couldn't hold a pencil, my right hand and arm had pins and needles, and I was confused.
49 2021-05-20 sensory loss, numbness Within 1 week, it triggered a bad MS attack. It should not be given to autoimmune people. First I go... Read more
Within 1 week, it triggered a bad MS attack. It should not be given to autoimmune people. First I got numbness in one hand, then the other. My mri showed an enhancing cervical spine lesions cotreslsting with these symptoms. Then a week later I lost sensation in my foot, then the other, then spreading up my leg, I?m in the hospital now on days of high dose steroids. My nurse told me I?m not the only one she sees here this happens to as well as other autoimmune patients of other autoimmunity. I think those of us autoimmune who are not taking immune suppressing drugs get even worse flare ups. This needs to be a warning to people. They could become permanently disabled G-d forbid.
49 2021-05-20 tremor At 18:36 pt chief complaint is dizziness, pt assessed to be sweating and shaking. Pt denies feeling ... Read more
At 18:36 pt chief complaint is dizziness, pt assessed to be sweating and shaking. Pt denies feeling cold. Pt vitals taken at 18:36 are Temp-97.8 HR-106 RR-20 BP-140/100 O2-100%. Pt transitioned to laying down position. Pt denies any additional symptoms. Pt monitored by observation RN. Pt vitals taken at 18:46 are Temp-97.7 HR-97 RR-16 BP-121/100 O2-99% Pt observed to still be shaking. Pt offered EMS call, pt denies. Pt observed to still be shaking at 19:00 with no reported resolution of dizziness. Observation RN called EMS. 19:10 EMS arrives on scene to assess pt. EMS reports normal heart rhythm, BP-130/82, with all other vitals within normal limits. Pt refused to go with EMS and signed AMA waiver from EMS. Pt suddenly reports feeling better and walked out with her husband at 19:35.
49 2021-05-21 weakness 5/19/21 -- Blurred vision, headache, nausea, lightheaded, stomach ache, disoriented, sweating, right... Read more
5/19/21 -- Blurred vision, headache, nausea, lightheaded, stomach ache, disoriented, sweating, right ear plugged, temp 98.9, legs feel heavy. Felt like I was going to pass out several times. 5/20/21 -- Temp 98.4, nausea, dizzy, sluggish, oximeter 96%, joint pain, blurred vision, weak, chills. Went home early from work. 5/21/21 -- Nausea, blurred vision started around 2 pm, headache, fatigue, stomach ache, dizzy, Taking pepto bismol & Ibuprofen
49 2021-05-21 cold extremities, tremor, feeling cold Rapid heart beat, tingling lips, sensation of throat closing, hard to swallow, body trembling, i fel... Read more
Rapid heart beat, tingling lips, sensation of throat closing, hard to swallow, body trembling, i felt cold, hands were cold and my face was a little red. Blood pressure and pulse ox taken twice. 159/57 (not my normal). Was given several bottles of water and cookies. Was observed for approx. 45mins. Symptoms slowly got better. Was told ok to leave and that i should take some benedryl after i left. Developed some hives on my chest and neck after I left the facility. Took benedryl as instructed. Hives went away. Throat still feels a little swollen.
49 2021-05-21 tremor, numbness, flushing, feeling hot Within 5 minutes of injection I experienced: Tingling in lips and mouth, then to numb; Flushing (bri... Read more
Within 5 minutes of injection I experienced: Tingling in lips and mouth, then to numb; Flushing (bright red in face and chest); rapid heart beat, shaking, disorientation for roughly 10 minutes. I was given 50mg of Benadryl and stabilized. I remained slightly flushed and had tingling in my mouth and lips for the remainder of the evening. Another 50mg of Benadryl before bed. Tues am woke up feeling fine, took 25mg of Benadryl. By 1pm was experiencing: Tingling and numbness in lips; Flushing; Light wheezing Hot and painful skin and chills. Extreme lethargy I took another 50mg of Benadryl and my symptoms abated slightly. No difficulty breathing at any point. Another 50mg of Benadryl at ~11p. Tuesday am, another 50mg of Benadryl at ~8:30a, and still exhibiting the same symptoms w/ exception of wheezing. Note: I take Benadryl on a regular basis due to my cat allergy and it does not make me sleepy. These symptoms lasted for approximately a week. For the last three weeks I have had extreme lethargy - if I try to stay up and keep working, I become nauseous. My left leg is going numb on the left side along the leg periodically. Very infrequently I get a bit of numbness and tingling in my mouth. No more wheezing.
49 2021-05-22 discomfort 2 days post first covid vaccine shot, tightness in chest, and pressure on left side of the neck, las... Read more
2 days post first covid vaccine shot, tightness in chest, and pressure on left side of the neck, lasting 30-1 hour ocurrig intermittently. in addition to 5 days of nausea, headache, low grade fever. 3 weeks later experiencing difficulty getting a full breath intermittently. Negative SARS -CoV-2 PCR nasal swab.
49 2021-05-22 difficulty speaking Almost immediately after the shot was given I got a stabbing pain in my throat. I told the pharmaci... Read more
Almost immediately after the shot was given I got a stabbing pain in my throat. I told the pharmacist and he said that would have been too fast for a reaction. He told me to have a seat outside the door and get someone if I got worse. While sitting I began to feel like something was stuck in my throat, my voice got horse, I became dizzy and had a feeling of being disconnected with being there. I took a benadryl and I told the pharmacist he got me orange juice. I noticed the skin on my hands arms, legs, and feet got mottled. This had happened in a previous reaction. I took another Benadryl, The pharmacist took my blood pressure it was high and I was in tachycardia. He gave me a shot of epi and wanted to call the ambulance. I refused as my daughter was on her way. He asked me to wait 15 mins to see my reaction. The epi seemed to help, but my symptoms picked back up . I promised the phamacist if he gave me another epi shot I would head straight to the ER. So, I checked into ER and there they gave my IV fluids, IV Benadryl, Steroids, ad I think Pepcid. After watching me and symptoms subsided I was released. I had to take benadryl and steroids for the net 5 days to keep at no reaction.
49 2021-05-22 pain in extremity, tremor In addition to the listed adverse events of chills, arm soreness, swelling at the injection site, fa... Read more
In addition to the listed adverse events of chills, arm soreness, swelling at the injection site, fatigue, muscle ache, headache, and depressed appetite I had one additional symptoms that I don't believe was listed on the paperwork included with the injection. The chills included severe trembling which lasted about 3 hours (started at 12:12 AM on Saturday, May 22nd and ended at 3:38 on Saturday, May 22nd). I also had a body temperature drop to 97.0 degrees at around 5 PM on Saturday, May 22nd. I never had a detectable fever at any time during the 24 hours after having the vaccine, but I was taking Advil to help with the headache and muscle ache which may be why I never developed a fever. My body temperate ranged from 97.7 to 97.0 through the 24 hour period after the vaccine. Advil was started 12:30 AM.
49 2021-05-23 burning sensation body aches, temp of 101 even while alternating advil and tylenol, swollen lymph nodes, red painful ... Read more
body aches, temp of 101 even while alternating advil and tylenol, swollen lymph nodes, red painful swollen rash on arm that burns and itches
49 2021-05-23 feeling cold, tingling, burning sensation Soreness at injection site after first and second doses for a few days. Soreness in left armpit (s... Read more
Soreness at injection site after first and second doses for a few days. Soreness in left armpit (swollen lymph nodes) after first dose for a few days. Tingling/burning/chilling sensation in feet (almost constant from onset till time of reporting - 10 days), sometimes also in legs and arms, and once in scalp. Rash at injection site two days after second dose (05/21/2021), still present at time of reporting. Swollen lymph node near left clavicle two days after second dose, still present at time of reporting. Swollen
49 2021-05-23 muscle twitching, pain in extremity, tingling, weakness The first night symptoms included insomnia, joint pain, stomach cramps, sweats and general malaise t... Read more
The first night symptoms included insomnia, joint pain, stomach cramps, sweats and general malaise that continued until the following evening. Over the next six days low energy, headaches and brain fog. Then random muscle twitches began. One week after the injection frequent muscle twitches up to 30 through the night that would wake me from sleeping. The next few days significant increase in heart rate upon standing or with any physical activity. Increased blood pressure up to 179/108 with headache. Heart Palpitations became almost constant with strong and painful skipped beats and bounding heart rate which caused chest pain, light headedness and shortness of breath. Within the following week I was experiencing gastric reflux, bloating and pale stools. Tingling and pain in feet and lower legs.
49 2021-05-23 pain in extremity Tiredness, headache, injection site pain, upper arm pain, nausea - started within hours of first in... Read more
Tiredness, headache, injection site pain, upper arm pain, nausea - started within hours of first injection and lasted a couple of days. Around 11:45pm the same day, I started feeling like I might pass out. Vertigo when I stood. Soon after vomited. These later symptoms did not last very long.
49 2021-05-23 tingling There were not adverse events at the time the shot was administered. I started displaying symptoms ... Read more
There were not adverse events at the time the shot was administered. I started displaying symptoms on or around May 10th with tingling in fingertips that I couldn't pin point and joint pain in my left hand below my knuckles (palm side). Around May 17th, I got swelling in my feet (I took photos) and May 18th, I started to feel itching on the back of my left thigh with no symptoms of a rash. I woke up on May 19th with what looked like ant bites but by the 20th, I couldn't touch it. I went to urgent care on May 21st and was diagnosed with shingles.
49 2021-05-24 weakness, tingling, pain in extremity, tenderness, numbness Initially in the first 24 hours my arm became very swollen and hot and sore to touch. Gradually ove... Read more
Initially in the first 24 hours my arm became very swollen and hot and sore to touch. Gradually over the next few weeks I began to have weakness with numbness and tingling accompanied by hypersensitivity to touch. Increasingly unable to use my left arm to hold anything, steer the car, hook my bra, sleep on my left side...The pain gradually increased and radiated from the insertion of the deltoid up into my shoulder and down into my elbow. I tried bracing, I tried, cold packs, heat packs, tens unit, lymph drainage, and exercises. While I did not get any pain relief or return of strength with any of the above methods I did prevent loss of motion. At 8 wks post injection with no improvement and continued loss of f
49 2021-05-24 night sweats, coordination abnormal Lump in left neck - Ultrasound and MRI completed radiology reports shows inflammation, infection or ... Read more
Lump in left neck - Ultrasound and MRI completed radiology reports shows inflammation, infection or neoplastic Extreme fatigue Unexplained weight loss Achy spine Joint pain in elbows, knees, neck, shoulders Itchy Bruising Late period Brain fog Coordination/stability issues Sore Throat Headaches Night Sweats
49 2021-05-24 pain in extremity Patient came to the pharmacy 5/25/21 at 1:20pm to alert us that she had reactions that started 4-5 d... Read more
Patient came to the pharmacy 5/25/21 at 1:20pm to alert us that she had reactions that started 4-5 days after getting her first dose of Pfizer. She reports that her blood sugar increased >400 and >600 4-5 days after the dose. The patient spoke with her Dr and the Dr told her to increase her Lantus and Apidra. The patient also reports getting pain in her right leg that caused trouble walking, bruising on hip that both started 4-5 days after the dose. Patient reports headache, insomnia due to pain and increased blood sugar. Patient reports now sleeping a lot because of exhaustion and having to check her blood sugar every 2 hours and drink lots of water as directed by her Dr. Patient says she finally got her blood sugar down below 120 on Friday 5/21/21. Patient reports she lost some vision and had blurry vision in her left eye that started 5-6 days after the dose. Patient says her A1C was 5.6 before the Pfizer dose and after the dose her blood sugar was uncontrolled. Patient says her Dr told her to go to the ER if her symptoms continued. Patient also spoke with someone at the CDC and they told her they would follow up with her regarding her symptoms and they will let her know if she should get her second dose.
49 2021-05-24 pain in extremity This is a spontaneous report from a contactable other hcp from Pfizer-sponsored program. A 49-years-... Read more
This is a spontaneous report from a contactable other hcp from Pfizer-sponsored program. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 subcutaneous, administered in Arm on 28Jan2021 (Batch/Lot Number: EN5318) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. On 28Jan2021, it was reported that patient arm was squeezed, and second dose was administered in subcutaneous tissue instead of doing an intramuscular into the deltoid muscle and on a patient arm is even sore on an unknown date in 2021. The patient wanted to know about efficacy of the medication and if Pfizer recommends me to get another dose. Patient reported that a doctor meets up under the theme "Don't Grieve my Arm" as this subcutaneous administration was a "systemic problem". The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
49 2021-05-25 numbness pain at injection site and surrounding area, numbness to cheek and tongue, no swelling
49 2021-05-25 migraine 3 days after second vaccine started with headaches which got worse on day 5 after vaccine; I went to... Read more
3 days after second vaccine started with headaches which got worse on day 5 after vaccine; I went to ER for migraine and high blood pressure of 163/113; I went to ER for migraine and high blood pressure of 163/113; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318) via unknown route of administration on 27Jan2021 14:00 at right arm as a single dose for Covid-19 immunization. The patients medical history included Gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS) and anxiety. No Known allergies were reported. Concomitant medications included famotidine (PEPCID), calcium, multivitamin and Birth control pills. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 on 06Jan2021 14:00 (Lot Number: EL0142) at right arm as a single dose for Covid-19 immunization. It was stated that 3 days after second vaccine started with headaches on 30Jan2021 12:00 PM which got worse on day 5 after vaccine I went to ER for migraine and high blood pressure of 163/113 on an unknown date in 2021. Was given IV meds for migraine and help Bp come down to 144/98 on an unknown date in 2021. The patient had taken covid test post vaccination, test type was reported as Nasal Swab and covid test name post vaccination was reported as Rapid with covid test result as negative on 01Feb2021. The outcome of headache was not recovered and for other events was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-05-26 weakness, pain in extremity Starting 2 days from the vaccine, I woke up and I had decreased range of motion and extreme pain in ... Read more
Starting 2 days from the vaccine, I woke up and I had decreased range of motion and extreme pain in my left upper extremity. I had decreased strength exclusively in my left upper extremity. On 01/27/2021 I went to walk in clinic. They gave me some pain medication and sent me home. On 02/04/2021, I saw an orthopedic surgeon. He gave me some exercises to do at home. He also sent me to physical therapy. I received a steroid shot from the dr. I am still in physical therapy. I have a follow up with an orthopedic surgeon today . I was diagnosed with impingement syndrome.
49 2021-05-26 numbness, pain in extremity Unspecified lot, unspecified arm. Pain, swelling. Per patient: MELAS patient. First Shot Pfizer. ... Read more
Unspecified lot, unspecified arm. Pain, swelling. Per patient: MELAS patient. First Shot Pfizer. Pain in arm and chest. Unilateral numness of face/tongue and unilateral swelling of lips. One shot benadryl. Improved swelling.
49 2021-05-27 mild one side paralysis, inability to speak 49 y/o female without significant PMH other than anaphylaxis from a dental procedure, who presents ... Read more
49 y/o female without significant PMH other than anaphylaxis from a dental procedure, who presents to the emergency room with multiple complaints after receiving her second SARS-CoV-2 Pfizer vaccination today at about 3-3:30 PM, lot number not current available. The patient's significant other/boyfriend was driving when he noticed the patient suddenly started to complain of shortness of breath with chest pain and a maculopapular rash which later was followed by expressive aphasia and left hemiparalysis. She received Pepcid, solumedrol and Benadryl for the rash in the ER with improvement. Code neuro was called and TPA was given. Post TPA she was alert and oriented and she could currently write with her right hand and think of the words she has to say. She had associated blurry vision which has resolved after TPA was administered. She also was not able to move her left lower extremity nor her left upper extremity which is also improving to some extent after TPA administration. So far CT/CTA head and CTA neck are negative and she has been admitted for likely acute cerebral vascular accident.
49 2021-05-28 numbness coughing; face went numb as well as her tongue and hands for two and half days; face went numb as we... Read more
coughing; face went numb as well as her tongue and hands for two and half days; face went numb as well as her tongue and hands for two and half days; maybe she had an allergic reaction to the first one; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events for two patients. This is one for two reports. A 49-year-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04May2021 (Batch/Lot Number: EW0171) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that for the first 15 minutes she was fine but aafter like 25 minutes, her face went numb as well as her tongue and hands for two and half days. She was "feeling like death for two days and a half ." Because she needed to work that day, she took fexofenadine (ALLEGRA 180 mg) because "it's for allergies" and massaged her face, tongue and hands. After that, she felt okay. Her daughter, aged 18 had the same vaccine, and had the same exact reaction but received it at the+3 hospital. Her sister received Pfizer Covid 19 vaccine but in its a 90 day interval between doses. Her doctor told her maybe she had an allergic reaction to the first one and wasn't sure if she should get the second dose. She was told to call Pfizer to see what they recommend. Primary care told her to call Pfizer to make sure if she is supposed to take the second one or if she needed to choose a different kind like Moderna or maybe Johnson and Johnson because of the side effect. Patient also stated "after my shot, I had horrible coughing. I am coughing for like 2 weeks but I don't know if it is related with my vaccine or not. I am going to hospital tonight to check." Outcome of the event coughing was unknown, and of remaining events was recovered on an unspecified date. Additional information has been requested.
49 2021-05-28 migraine Headache; Bad migraine; This is a spontaneous report from a contactable consumer (patient) received ... Read more
Headache; Bad migraine; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6203) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient received her first dose of the Pfizer vaccine earlier, last week on 26Feb2021 and she started experiencing headache, and it's a bad migraine. The patient wanted to know if it was okay to receive her second vaccine. She also mentioned that she had to drive 5 hours to get that vaccine and she do not think she want to drive the next time with a headache. So, that is why she asked if they could be moved. The patient mentioned treatment as Just Excedrin, Tylenol. Outcome of the events was unknown. No follow-up attempts are possible. information about lot/batch cannot be obtained.
49 2021-05-28 pain in extremity, weakness Sore arm; weakness; This is a spontaneous report from a contactable consumer (patient). A 49-year-ol... Read more
Sore arm; weakness; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient not pregnant received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 26Feb2021 13:00 (Lot Number: EN6203) as single dose (at age of 49-year-old) for covid-19 immunisation. Medical history was reported as none. Patient had no known allergies. There were no concomitant medications. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. On 26Feb2021 15:00 patient experienced sore arm and weakness. No treatment was received. Patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
49 2021-05-28 sensory loss lots of bodyaches, headaches, difficulty swallowing, loss of sensation on fingers difficulty walkin... Read more
lots of bodyaches, headaches, difficulty swallowing, loss of sensation on fingers difficulty walking, cognitive problems, memory problems, fatigue, brain fog, feel like I have the flu everyday.
49 2021-05-30 hot flush I had a period that lasted over 3 weeks, including hot flashes, random bleeding starting and stoppin... Read more
I had a period that lasted over 3 weeks, including hot flashes, random bleeding starting and stopping. Also started a Retina detachment, and had vitrectomy on April 5.
49 2021-05-30 numbness It felt weird from the get go. I felt it go into my arm. That night I could barely move my left arm.... Read more
It felt weird from the get go. I felt it go into my arm. That night I could barely move my left arm. It got better, but in the days that followed I got a pain in my neck and shoulder. I thought maybe I slept wrong. I ended up going to a physical therapist, a massage therapist, and a chiropractor to get some relief. I had some numbness and tingling down the left side of my arm with my ring finger and my pinky. I got no relief from that. I went to my doctor and he found a knot under my arm. I thought the swelling from that might have hit a nerve. My PCP sent me to another doctor, who is a surgeon. He ordered an ultrasound. When that came back, it came back as a swollen lymph node. I went and had a biopsy done. When it came back everything looked good. Last week, I was taking off my dress and I was like "oh that hurts!". The lump under my arm was bigger and was hurting. I am having another ultrasound done Friday. It is still swollen and it has been like this since a few days after Jan 6 2021.
49 2021-05-31 flushing body flushing; Tachycardia; her heart was pounding; This is a spontaneous report from a contactable... Read more
body flushing; Tachycardia; her heart was pounding; This is a spontaneous report from a contactable nurse (patient). A 49-years-old, non-pregnant, female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 26Feb2021 15:00, at 49 years of age, (Batch/Lot Number: EN6202) as single dose for COVID-19 immunization. The patient medical history was not reported. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 05Feb2021 15:00 (Batch/Lot Number: EL9266) as single dose for COVID-19 immunization. The patient didn't receive any other vaccine in the previous 4 weeks. Concomitant medication included cetirizine hydrochloride (ZYRTEC) and fexofenadine hydrochloride (ALLEGRA), both taken for an unspecified indication since an unknown date. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. On 26Feb2021 15:15 the patient felt whole body flushing, which became tachycardia, and her heart was pounding. It resolved in 5 minutes. 15 minutes later the same symptoms occurred again lasting 10 minutes. The patient required visit to Emergency room/department or urgent care but no treatment was administered. At the time of the report the reported events were resolving. No follow-up attempts are possible. No further information is expected.
49 2021-05-31 pain in extremity sore arm; I am little concerned; Caller is concerned that the motrin affected the efficacy of her se... Read more
sore arm; I am little concerned; Caller is concerned that the motrin affected the efficacy of her second dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9810 and expiry date was not reported), via an unspecified route of administration, on 02Feb2021, as a single dose for COVID-19 immunization (to protect myself). The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: "EL3249" and expiry date was not reported), via an unspecified route of administration, on 14Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included that on Monday, she had slight procedure done on her leg and she was instructed by her physician to take Motrin. Concomitant medication included ibuprofen (MOTRIN). The patient reported that she had a procedure on Monday and took MOTRIN yesterday morning on 02Feb2021. She took her second shot late afternoon. The patient asked did she need to really worried that it was little you know the effectiveness of having the Motrin from the morning. She had her second dose of the Pfizer vaccine yesterday afternoon and she was concerned that the MOTRIN affected the efficacy of her second dose on 02Feb2021. The patient reported that this morning she didn't really feel that she had a side effect, and she was just having slight sore arm not much (no big deal) after the second dose of the Pfizer COVID 19 vaccine on 03Feb2021 and she was little concerned. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
49 2021-06-01 pain in extremity - Started getting my period every 2 1/2 weeks. Although I am almost 50 I have been very regular, eve... Read more
- Started getting my period every 2 1/2 weeks. Although I am almost 50 I have been very regular, every 29 days, up until injection. I have had 3 periods since April 29, and today is 6/2. - This may or may not be related, but i have awful muscle pain in my right leg that started 3 days after 2nd dose. It is unrelated to activity or clothing. Does not limit my activities - just a weird, dull ache in the muscle of my right quad.
49 2021-06-01 tingling numbness/tingling or vibrating feeling in lips; numbness/tingling or vibrating feeling in lips; tire... Read more
numbness/tingling or vibrating feeling in lips; numbness/tingling or vibrating feeling in lips; tiredness; light headedness; tingling sensation has spread to my entire body.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6202, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 02Mar2021 10:00 (at the age of 49-years-old) as unknown, single dose for COVID-19 immunisation. Medical history included diabetes mellitus, arthritis, morbid obesity, alopecia areata, psoriasis and sensitivity to glues used in band aids and other chemical sensitivities; all from an unknown date. Concomitant medications included glyburide, sitagliptin (JANUVIA), insulin aspart (NOVOLOG), insulin detemir (LEVEMIR) and telmisartan all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 02Mar2021 10:30, the patient experienced numbness/tingling or vibrating feeling in lips, tiredness and light headedness; tingling sensation has spread to my entire body on 02Mar2021. It was reported that numbness/tingling or vibrating feeling in lips occurred at just over half hour after dose. By end of the day the tingling sensation has spread to the entire body. The tingling was not over whelming but definitely there. The patient has also experienced tiredness and light headedness but to a minor degree. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible. No further information expected.
49 2021-06-03 weakness Fever; Joint pain; Weakness; This is a spontaneous report from a contactable consumer, the patient. ... Read more
Fever; Joint pain; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 16Mar2021 at 10:30 hours (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The medical history included high BP and cholesterol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 at 15:15 hours, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced fever, joint pain and weakness. The patient did not receive treatment for the reported events. The clinical outcome of fever, joint pain and weakness was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-06-03 feeling hot After the second vaccination have/had severe right arm swelling (still icing arm) entire upper arm s... Read more
After the second vaccination have/had severe right arm swelling (still icing arm) entire upper arm swollen no redness; hot to touch; Fever; chills; cold sore upper lip; This is a spontaneous report from a contactable other hcp. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), dose 2 via an unspecified route of administration, administered in Arm Right on 03Mar2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Patient had previously received first dose of vaccine (Lot number: EM9809) in left arm on 10Feb2021 at 12:30. Patient did not receive other vaccine in four weeks of vaccination.Patient has not been tested for COVID, post vaccination. The patient's concomitant medications were not reported. On 03Mar2021, patient experienced severe right arm swelling (still icing arm) entire upper arm swollen no redness, hot to touch, fever, chills the next day lasting 2 days. Also now have a cold sore upper lip after the vaccination. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of after the second vaccination have/had severe right arm swelling (still icing arm) entire upper arm swollen no redness, hot to touch, fever, chills, cold sore upper lip. The outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.
49 2021-06-03 numbness Perioral and hand numbness shortly after vax. No actual OP or chest sx. No rash. Pulse 83 Ox 97% ... Read more
Perioral and hand numbness shortly after vax. No actual OP or chest sx. No rash. Pulse 83 Ox 97% Likely vaccine reaction. Felt better with lying down and pushing PO fluids.
49 2021-06-03 tingling, numbness, cold extremities The tingling became almost numb in my feet at 72 hours; After the second vaccine both my feet and ha... Read more
The tingling became almost numb in my feet at 72 hours; After the second vaccine both my feet and hand became very cold and tingling; After the second vaccine both my feet and hand became very cold and tingling; This is a spontaneous report from a contactable consumer (patient). A 49-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: En6203), via an unspecified route, administered in Left arm on 03Mar2021 10:00 AM (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19 (prior to vaccination). Patient had no known allergies. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El3248), via an unspecified route, administered in Left arm on 09Feb2021 at 04:45 PM (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient had no other vaccination 4 weeks prior to Covid-19 vaccine. On 03Mar2021 at 06:00 PM (8 hours after the second vaccine), the patient experienced both her feet and hand became very cold and tingling. It has continued for four days - seemed to be worse at 72 hours and was hopefully improving on day 4. The tingling became almost numb in her feet at 72 hours (on 06Mar2021 at 10:00). She never had a feeling like this before. The patient had not tested for Covid-19 post vaccination. The patient had not received any treatment for the resulted events. The outcome of the events was recovering. No follow-up attempts are possible. No further information was expected.
49 2021-06-04 flushing Flushed; Malaise; Fatigue; She is diaphoretic; feel short of breath; Nausea; This is a spontaneous r... Read more
Flushed; Malaise; Fatigue; She is diaphoretic; feel short of breath; Nausea; This is a spontaneous report from a non-contactable other health care professional. A 49-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:EN6205) via unspecified route of administration on16Mar2021(at the age 49-year-old) and the patient had previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown)on an unspecified date via an unspecified route of administration as a single dose for COVID 19 immunisation .The medical history included patient was morbidly obese. On 16Mar2021 the patient had stayed for 15 minute waiting period after the injection and asked to stay another 5 minutes. The patient felt fine until she reached the front doors, then she had experienced flush, nausea, malaise/fatigue shortness of breath and diaphoretic. Therapeutic measures were taken as the result of the events included treatment with water and snacks. The patient responded to the treatment excellently. The patient was stable to go home and was discharged and advised to follow up with Primary care physician. The clinical outcome of flush, nausea, malaise/fatigue shortness of breath and diaphoretic were unknown. No follow-up attempts are needed. No further information is expected
49 2021-06-05 pain in extremity First dose was not much of an issue, I had the expected soreness in my arm where the shot was admini... Read more
First dose was not much of an issue, I had the expected soreness in my arm where the shot was administered. I would get an occasional twinge of pain ( as if I had the shot again). However, since I have had the second dose on 4/29/21 _ I am experiencing horrible pain in my deltoid, upper bicep and tricep. To the point that I cannot sleep due to the constant stabbing pain. I have rested the arm, iced it, heated it. I have seen the chiropractor, had massage therapy, and cannot find relief. The pain is AWFUL and stabbing and sharp. Yesterday I went to the orthpedic specialist and they say that it seems to be all muscular and likely inflammatory reaction from the vaccine. this is 6 weeks of a reaction.
49 2021-06-06 pain in extremity Started getting pain in calf. Blood clot ruled out. Now in both legs with no idea why
49 2021-06-07 muscle spasms 7 days after first vaccine left arm developed hives and severe itching. 10 days after first dose Le... Read more
7 days after first vaccine left arm developed hives and severe itching. 10 days after first dose Left hand developed clear white itchy rash. 18 days after first vaccine SEVERE swelling in right left and knee as well as severe cramping in calf muscle. OTC meds, ice and heat...nothing helps. Can not put pressure on that leg at all.
49 2021-06-07 tingling, burning sensation 6/2/21 A 1/2 inch long bump/rash appeared on the right side of my scalp. It didn't itch or hurt. 6/3... Read more
6/2/21 A 1/2 inch long bump/rash appeared on the right side of my scalp. It didn't itch or hurt. 6/3/21 I woke up with a headache on the right side of my head. Felt like a sinus headache, behind my eyes and sinus cavity. 6/4/21 Still had headache and bump on scalp. The right side of my face from my forehead to my eyelids had a painful burning sensation when even lightly touched, almost like a pins and needles feeling but painful. A linear rash appeared on my right middle forehead. 6/4/21 1:20 Doctor diagnosed shingles. By 3pm I had started a 7 day course of Valacyclovir 1 GM 3 times a day. By evening my head hurt to the point of taking 800mg Ibuprofen for relief every 8 hours. Extreme fatigue for the next 3 days. 6/5/21 Head pain continued, with rash spreading throughout right side of scalp and down right side of face, even on eyelids. 6/7/21 Symptoms began to lessen, but head pain in spurts. 6/8/21 Visit to Ophthalmologist at 11:20 am. No lesions on eye. Prescribed Steroid eye drops 2x a day for 1 week. No pain in eye. Head pain almost gone. Energy returning.
49 2021-06-07 tingling, numbness patient felt numbness and tingling in Left arm
49 2021-06-07 unresponsive to stimuli I had the expected fever and headache the day after the vaccine. I woke up vomiting during the night... Read more
I had the expected fever and headache the day after the vaccine. I woke up vomiting during the night. I had ongoing GI problems. One week after the vaccine I fainted one day during a walk with my husband. I woke up and I had lost control of my bladder but I was unaware of the fact that I was unresponsive. I lost consciousness for 2-3 minutes. I had Gastrointestinal problems for one month after the second dose of the vaccine. My stomach was upset and I had Diarrhea as well as a raw feeling in my stomach. I have never had those problems before. I recovered after one month approximately .
49 2021-06-08 feeling hot nausea; dizzy; vomiting; sometimes I feel hot; I feel chilled; This is a spontaneous report from a c... Read more
nausea; dizzy; vomiting; sometimes I feel hot; I feel chilled; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: 9NG198), dose 1 via an unspecified route of administration administered in Arm Left on 09Mar2021 at 11:30 (at 49-years age) as single dose of covid-19 immunisation. Medical history included seizure, endometriosis and had known Allergies: antibiotics sulfa medicines. Concomitant medications included zonisamide (ZONEGRAN) and levetiracetam (KEPPRA). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Other vaccine was not received in four weeks. On 09Mar2021 at 12:00, patient experienced nausea and dizzy and vomiting after first dose sometimes she feel hot and other times she feel chilled. No treatment was received for events. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
49 2021-06-08 pain in extremity Sore arm; This is a spontaneous report from a contactable patient. A 49-years old no pregnant female... Read more
Sore arm; This is a spontaneous report from a contactable patient. A 49-years old no pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in left arm on 19Feb2021 at 02:00 PM as a single dose for COVID-19 immunisation. Medical history included Dysfibrinogenemia. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient not received any other medications within 2 weeks of vaccination. The patient experienced sore arm on 19Feb2021 at 09:00 PM. Sore arm got worst on 2nd and 3rd day of vaccination. The patient experienced sore arm for about a week. The patient experienced soreness in arm similar to any other vaccine received as a child. Treatment was not received for event. The clinical outcome of sore arm recovered at time of reporting. No follow-up attempts are needed. No further information is expected.
49 2021-06-08 tingling both times I got the vaccine the side effects were few days later, I experienced severe bruising on ... Read more
both times I got the vaccine the side effects were few days later, I experienced severe bruising on my legs and hips and chest pain and palpitations followed by tingling nerve on the sides of my head and bloated body. I've been also experiencing stiffness on my hands and wrists.
49 2021-06-09 weakness Fever, Chills, severe body aches, congestion , headache, weak/extremely tired, tightening of chest ... Read more
Fever, Chills, severe body aches, congestion , headache, weak/extremely tired, tightening of chest for 2 two weeks
49 2021-06-09 difficulty speaking rasp voice and hoarseness
49 2021-06-09 tingling, numbness I had tingling and numbness in my arm, hand and face for 10 days with twitching of my eye. I ran a f... Read more
I had tingling and numbness in my arm, hand and face for 10 days with twitching of my eye. I ran a fever over 101 for 8 days; I had tingling and numbness in my arm, hand and face for 10 days with twitching of my eye. I ran a fever over 101 for 8 days; I had tingling and numbness in my arm, hand and face for 10 days with twitching of my eye. I ran a fever over 101 for 8 days; I ran a fever over 101 for 8 days; I had total loss of apetite with a 7 pound weight loss over 10 days; I had total loss of apetite with a 7 pound weight loss over 10 days; I have extreme fatigue and joint pain that still persists and is debilitating; I have extreme fatigue and joint pain that still persists and is debilitating; This is a spontaneous report from a contactable other hcp. A 49-years-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL0142) via an unspecified route of administration, in arm left on 13Jan2021 18:15 as first dose, single dose for COVID-19 immunization. Medical history included thyroid cancer, hashimotos, GERD and vitamin d deficiency. Patient had known allergies of penicillin and sulfa. Concomitant medications included levothyroxine sodium (SYNTHROID), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), esomeprazole magnesium (ESOMEPRAZOLE MAGNESIUM) and ampicillin trihydrate (ALPRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. On 15Jan2021 the patient had tingling and numbness in arm, hand and face for 10 days with twitching of my eye, ran a fever over 101 for 8 days, total loss of appetite with a 7-pound weight loss over 10 days, extreme fatigue and joint pain that still persists and is debilitating. The patient underwent lab tests and procedures on Jan2021 which included body temperature over 101 and weight: 7-pound weight loss had total loss of appetite, on 20Jan2021 and 27Jan2021 Covid test result: Negative, sars-cov-2 test: negative. The patient was received treatment currently on my second Medrol dose pack. The patient was currently on her second steroid pack with no relief in symptoms. She was advised to wait to take her second shot by her physician. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
49 2021-06-09 tremor WITHIN TWO MINUTES OF GETTING OFF THE CHAIR I STARTED HAKING AND PASSED OUT. COULDN'T BREATH NEED... Read more
WITHIN TWO MINUTES OF GETTING OFF THE CHAIR I STARTED HAKING AND PASSED OUT. COULDN'T BREATH NEEDED AN OXGEN MASK. MY BLOOD PRESSUE DROP VERY LOW.
49 2021-06-10 tingling, pain in extremity, weakness Arm pain originating in the deltoid region spanning down length of arm. Patient reports limited rang... Read more
Arm pain originating in the deltoid region spanning down length of arm. Patient reports limited range of motion, pain, weakness, and tingling in fingertips.
49 2021-06-13 weakness vomiting, diarrhea, severe chills, headache, high fever 103.8, no energy
49 2021-06-13 feeling hot This started with feeling sick and a medium case of the chills and then all of a sudden I?ll get war... Read more
This started with feeling sick and a medium case of the chills and then all of a sudden I?ll get warm, almost hot, ( my first dose I had the chills in a very BAD way), muscle pain, tiredness. The long adverse effects are chills and eventually ill get warm, and muscle pain.
49 2021-06-14 migraine Bad headache; Migraines; Nausea; Vomiting; Body aches; not well.; This is a spontaneous report from ... Read more
Bad headache; Migraines; Nausea; Vomiting; Body aches; not well.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0171, expiration date unknown) via an unspecified route of administration in the arm left on 03May2021 at 15:00 at age of 49-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history includes Vitamin D deficiency (managed with supplements), known allergies with penicillin. Patient previously received amoxicillin and had allergies to it. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EP7533, expiration date unknown) via an unspecified route of administration in the left arm on 12Apr2021 at 02:30 PM at age of 49-year-old for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin D, multivitamin, biotin, hyaluronic acid. Patient had a very bad headache in the morning after 2nd dose of BNT162B2. Patient drank a lot of water but it only temporarily got better. Patient had been dealing with headaches and migraines ever since even though she had no history of migraines. Patient had been to the ER twice. Patient also had nausea, vomiting, body aches. She still was not well. Onset date of the events was reported as 04May2021 at 09: 00 AM. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Patient was hospitalized for 1 day. Seriousness criteria of the events was reported as hospitalization and disabling/incapacitating. Patient received migraine medications as treatment for the events. Outcome of the events was not recovered. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Patient had COVID Test type post vaccination by nasal swab on 27May2021 which was negative.
49 2021-06-14 muscle spasms I generally (for many years) have 5 day menstrual cycles. Since my vaccine, my periods have lasted ... Read more
I generally (for many years) have 5 day menstrual cycles. Since my vaccine, my periods have lasted 8-9 days with heavier cramping and side effects. The periods have also been heavier. I also am experiencing acne since my vaccination. The acne is appearing in unusual places on my face and with greater severity (large knots). I generally have clear skin.
49 2021-06-14 tremor, feeling of body temperature change After 10 hours of 2nd dose, I experienced anaphylaxis - rash all over my entire body, nausea, low bl... Read more
After 10 hours of 2nd dose, I experienced anaphylaxis - rash all over my entire body, nausea, low blood pressure and my body was shaking from being so cold even though I felt like I was on fire from the inside.
49 2021-06-15 weakness, tenderness Robust immune (flu-like) response within 12 hours of dose. The week following 2nd dose felt tired & ... Read more
Robust immune (flu-like) response within 12 hours of dose. The week following 2nd dose felt tired & achy. Beginning 3 weeks after 2nd dose: total exhaustion, muscle fatigue, joint pain & tenderness and overall weakness which has continued to persist. The main complaints are sore shoulders, wrists, and hips. Dr suspecting Polymyalgia Rheumatica.
49 2021-06-15 bell's palsy seen in ER for Bells Palsey facial effects
49 2021-06-15 flushing flushing, difficulty breathing, rapid heart pulse (146), elevated blood pressure (183/103). Last an... Read more
flushing, difficulty breathing, rapid heart pulse (146), elevated blood pressure (183/103). Last anaphylaxis 8 years ago with allergy shot; received 2 epi-pens. Fortunately, 2nd dose was done at the Urgent care setting.
49 2021-06-15 pain in extremity, limb paralysis, facial pain Paralysis of Left Arm, and excruciating pain radiating to armpits, and left side of neck and face fo... Read more
Paralysis of Left Arm, and excruciating pain radiating to armpits, and left side of neck and face for about 36 hours. Severe pain of the left arm persisted for the following two days.
49 2021-06-15 seizure like phenomena Pt. with hx of seizure activity with vaccination displayed seizure like activity approximately twent... Read more
Pt. with hx of seizure activity with vaccination displayed seizure like activity approximately twenty minutes after second dose of vaccine. No LOC. Pt. experienced no respiratory distress during incident. Activity lasted 3 minutes. Pt. presented confused and lethargic after activity. EMS involved and initial vitals were stable. Pt. A&Ox4, states this is similar to seizure activity experienced within the last month and chronically. EMS released pt. to home, pt. exited facility in company of family who affirmed they were driving pt. home and would remain with pt. through the rest of the day.
49 2021-06-16 weakness neck pain; body aches; almost passed out; dizziness; weakness; difficulty breathing; feeling unwell;... Read more
neck pain; body aches; almost passed out; dizziness; weakness; difficulty breathing; feeling unwell; injection site pain; few chills; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 at vaccination age of 49-year-old via an unspecified route of administration in the left arm on 16Mar2021 18:00 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history included hypothyroidism, fibromyalgia, leaky gut/dysbiosis, recurring skin rashes/sinus infections, hypothyroidism (Hashimoto's), and known allergies to gluten and Dilaudid drugs. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included unspecified medications (too many to list here). The patient previously took benzoyl peroxide and thimerosal, but both were known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that 4 hours after the vaccine (16Mar2021 22:00), the she experienced dizziness, weakness, almost passed out, difficulty breathing, feeling unwell, injection site pain and few chills. It was reported that 14 hours after the vaccine (17Mar2021 08:00), the patient had dizziness, weakness, body aches, neck pain and chills. The patient did not received treatment for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The patient did not consider the events as serious. The outcome of the events was recovering. Information on Lot/Batch number has been requested.
49 2021-06-16 muscle spasms, feeling jittery Adverse reaction initially reported under temporary VAERS report number 332643 from encounter at vac... Read more
Adverse reaction initially reported under temporary VAERS report number 332643 from encounter at vaccination site. Pt's treatment continued in ED on the same day as vaccination 2/26/21. Of note, though potentially unrelated, pt was seen for Pericarditis on 4/22 in an outside ED. Update discovered during routine review of patients with documented COVID vaccine allergy. At vaccination site: Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given. Update 6/17/21: Pt has a hx of numerous allergies to medications and food. Azithromycin (anaphylaxis?), COVID vaccine (itching/dizziness), Doxycycline (rash), Ibuprofen (swelling), Penicillins (rash), sulfa (rash), Gluten, house dust, polyester, cleaning products (SOB). Pt also has seasonal allergies (unspecified) and intolerances to aspirin, levothyroxine, and percocet. Pt has a PMH of osteoporosis, migraines, hyperlipidemia, hashimoto's disease, hx of H. pylori, GERD, Diverticulitis, Asthma, arthritis, anxiety, anemia, and obesity. Past surgical hx of tonsillectomy and cholecystectomy. Recent abnormal labs 1/4/21 TSH 0.08 mcIU/mL, and 3/13 was 0.01 mcIU/mL. Pt went to the ED directly from the vaccination site. Pt was biba 2hrs after vaccination. After Benadryl, pt developed tingling in arms, sob, chest tightness. After Epi, pt was "jittery" with SOB. in the ED pt complained of difficulty breathing and difficulty swallowing. No rash, swelling or wheezing. Pt is anixous. Pt was given NS 1000mL, methylprednisolone sod succ 125mg x1 and pepcid 20mg x1 in ED. Pt improved and was released from ED ~2hrs after presentation. Pt discharged from ED with prescriptions for the following: diphenhydrAMINE (BENADRYL) 25 mg capsule Take 1 capsule by mouth every 6 (six) hours as needed for Itching. predniSONE (DELTASONE) 20 MG tablet Take 1 tablet by mouth daily x5days. Medications at the time of vaccination: gabapentin (NEURONTIN) 100 MG capsule Take 1 capsule by mouth 3 (three) times daily. gabapentin (NEURONTIN) 300 MG capsule Take 1 capsule by mouth at bedtime. liothyronine (CYTOMEL) 5 MCG tablet Please take 1 tablet in the morning and 1 tablet in the evening thyroid extract, porcine, (ARMOUR) 60 mg tablet Take 2 tablets in the morning and 3 tablets in the evening on empty stomach cholecalciferol, vitamin D3, (VITAMIN D3 ORAL) Take by mouth. 50,000units once a week per pt cholestyramine (QUESTRAN) 4 gram powder Take 4 g by mouth daily.Avoid taking other medications within 4-6 hours before or after the cholestyramine. Take cholestyramine at night with dinner. cyclobenzaprine (FLEXERIL) 5 MG tablet Take 1-2 tablets by mouth at bedtime as needed for Muscle spasms. omeprazole (PRILOSEC OTC) 20 MG tablet Take 1 tablet by mouth every morning 30min before breakfast. On 4/22/21: Pt presented to outside ED with Chest pain and diagnosed with pericarditis. From Provider Note at outside ED: Assessment and Plan: Per H&P 4/23/21, "50 Y female with history of BMI 53, hypothyroidism, allergic rhinitis, obesity, chronic neck pain, migraine, celiac disease admitted 4/22/21 with shortness of breath, jaw pain." PERICARDITIS -EKG consistent with pericarditis -ruled out for MI, chest CT angiogram negative for large pulmonary embolus, MIBI normal -Echocardiogram normal -appreciate Cardiology Service Dr.'s recommendations -start colchicine bid for 1 month, then qday for another 3 months. EOT 8/24/21 -continue indomethacin for another few days RTC then change to prn MILDLY ELEVATED D-DIMER -Likely related to inflammation from pericarditis CHRONIC NECK PAIN -home gabapentin (neurontin) 300mg oral 2X per day REACTIVE AIRWAY DISEASE -On ciclesonide (alvesco) 80mcg 2 puffs 2X per day + albuterol and ipratropium inhaler (combivent) 1 puff 4X per day -pt reports pulmonary symptoms with allergies sometimes - consider PFTs after pericarditis treated HYPOTHYROIDISM -home thyroid armor 180 / 120mg oral 2X per day + liothyronine 5mcg daily ONYCHOMYCOSIS -home terbinafine (lamisil) 250mg daily
49 2021-06-16 pain in extremity headache; sore arm; dizziness; This is a spontaneous report from a contactable consumer (patient). A... Read more
headache; sore arm; dizziness; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: ER8735, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 21Apr2021 10:30 (at the age of 49-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included sulfa drugs and avocado allergy both from an unknown date. Concomitant medication included multivitamin taken for an unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On an unspecified date, the patient experienced headache, sore arm, and dizziness. It was reported that the patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: ER8734, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 31Mar2021 10:00 (at the age of 49-years-old) for COVID-19 immunisation and experienced severely dizzy, continued for 2.50 weeks 24/7. The only time she felt ok was laying down. It started to get better in time for her second dose. After second dose it didn't get worse. Only a headache in the middle of the night and a sore arm for about a week. The dizziness has not gone away completely. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events included meclizine. The outcome of the events was recovered with sequels. No follow-up attempts are possible. No further information expected.
49 2021-06-16 pain in extremity I am getting the sharp dull, it's a mixed feeling thing; It is dull, dark, and very deep into my bon... Read more
I am getting the sharp dull, it's a mixed feeling thing; It is dull, dark, and very deep into my bone it feels; Itching; Lymph nodes do not hurt as much as they did; Fever; Headache; This travelling pain; Its very weird, sort of maybe in my calf, or in my thigh or arm; Dizziness; This is a spontaneous report via Pfizer Sponsored Program. A contactable consumer (patient) reported a 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch Number: EW0186), intramuscular on 25May2021 (at an age of 49-years-old) as 2nd dose, single dose for covid-19 immunization. The patient's medical history included hashimoto's thyroiditis, pernicious anemia, from an unspecified date in 2002 and anxiety from an unspecified date. The patient's concomitant medication included Levothyroxine (MANUFACTUERER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose once a day for autoimmune thyroiditis; Vitamin d3 (VITAMIN D3), (MANUFACTUERER UNKNOWN), via an unspecified route of administration on an unspecified date at 1000 IU daily for pernicious anaemia (When probed for the treatment of Pernicious Anemia, Consumer stated, "Actually, I just received high levels of Vitamin D tablets. Like 50,000 units per week and then another 25 units each day. It is over the counter this time but it is Vitamin D3. So I take 1000 units per day. Yeah each day and then 50,000 units per week."); Escitalopram oxalate (LEXAPRO) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at two and a half tablets once a day for anxiety. On an unspecified date. The patient previously took first dose of bnt162b2 on 22Apr2021 (Batch/Lot Number: EW0169) for covid-19 immunization. On 26May2021, the patient experienced dizziness. On an unspecified date, the patient experienced I am getting the sharp dull, it's a mixed feeling thing, it is dull, dark, and very deep into my bone it feels, itching, lymph nodes do not hurt as much as they did, fever, headache, this travelling pain, its very weird, sort of maybe in my calf, or in my thigh or arm. The patient experienced with ongoing side effects it was been a little over a week since the vaccination patient had lot of itching with dizziness continuing and patient was getting the sharp dull, it was a mixed feeling thing. So, it was dull, dark, and very deep into my bone it felt. The patient reported that the only thing that improved was her Lymph nodes do not hurt as much as they did. But patient was still having the extreme dizziness, the fever, headaches, and this travelling pain that patient could not explain very well. When confirmed if the anatomical site of second shot was same for both shots, Consumer stated, "Yes I did and then the second shot, I had a lot of itching with it. Very very dizzy. Still very dizzy." It was very weird, sort of maybe in her calf, or in her thigh or arm. The pain that really hurt, they were instant. So, they did not stay long but it kind of took her breath away because hurt so bad but then it disappeared. The patient took Tylenol 500 mg to try and get my temperature down. It did not help with the dizziness and it did not help with these shocking pains and mixed Tylenol with 600 milligrams of Ibuprofen. The seriousness of the events was unspecified. The clinical outcome of the lymph nodes do not hurt as much as they did was recovering and for the dizziness, I am getting the sharp dull, it's a mixed feeling thing, it is dull, dark, and very deep into my bone it feels, itching, fever, headache, this travelling pain, its very weird, sort of maybe in my calf, or in my thigh or arm were not recovered. Further information is requested.
49 2021-06-17 depressed level of consciousness, numbness, tingling 15 minutes after vaccination patient complained of arm tingling and numbness as she attempted to che... Read more
15 minutes after vaccination patient complained of arm tingling and numbness as she attempted to check out. we asked her to stay a few more minutes to make sure she felt ok. she sat back down and started coughing. we asked her to take her mask off so she could breathe easier. she started to wheeze. we asked about previous allergies and she confirmed that she had anaphylaxis to 2 different vaccines (tetanus and MMR). we monitored her breathing which became more labored. she started to lose consciousness. we administered an epi-pen in the right thigh. within seconds her breathing relaxed. we called for the emergency department. they came and transported her to the ED for further evaluation. she was treated with antihistamines and solu-medrol and then released.
49 2021-06-17 numbness has numbness in both hands, but mainly her right hand, after the second vaccine; This is a spontaneo... Read more
has numbness in both hands, but mainly her right hand, after the second vaccine; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 14Jun2021 as a single dose (at the age of 49-years-old) for covid-19 immunisation at hospital. The patient medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. On Jun2021, patient had numbness in both hands, but mainly her right hand, after the second vaccine. Patient stated that for a half hour to 45 minutes, she had numbness in her right hand and stated that hand feels like if you hold a body part in the same position, for a long time, and it feels numb. Patient clarified that she feels the numbness in both of her hands, mainly her right hand. Patient asked if it was normal to have this effect or she should worry and asked if this effect was alright to had, or should she go to a doctor. The outcome of the event was unknown. Information on batch/Lot number was not received. Further information has been requested.
49 2021-06-17 migraine Large knot/lump in armpit of my left arm. Where my lymph node is located. Severe fever, chills and ... Read more
Large knot/lump in armpit of my left arm. Where my lymph node is located. Severe fever, chills and Migraine
49 2021-06-18 feeling cold Same day: Injection site pain, swelling, and redness almost instantly (as opposed to first dose whic... Read more
Same day: Injection site pain, swelling, and redness almost instantly (as opposed to first dose which didn't happen until the following day). Cannot lift arm. Dizziness, nausea, tiredness, headache, chills (mostly feeling really cold). Next day: Headache (worse than previous day), dizziness, extreme tiredness, sore throat, full body aches (muscles, joints), nausea, chills, funny taste. Injection site pain, swelling and redness continued. Day 3: Only tiredness, a little sore overall. Injection site itchiness and it feels really warm. Injection site pain, swelling, and redness continued. Day 4-5: Injection site pain, swelling, redness, itchiness, warmth continued. Day 6-7: Only injection site mild pain, swelling and warmth continues.
49 2021-06-18 speech disorder, muscle spasms my upper right side of my lip was feeling numb and weird; my speech was compromised; my left eyelid ... Read more
my upper right side of my lip was feeling numb and weird; my speech was compromised; my left eyelid was twitching and it lasted for some time; I have felt changes in my mood and easily irritable; I have felt changes in my mood and easily irritable; feeling pain in my joints; Nassau; continue to feel lethargic and tired; chest pain; feeling tightness, spasms in my back; feeling tightness, spasms in my back; feeling lethargic; This is a spontaneous report received from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in right arm single dose for COVID-19 immunization on 18May2021 10:30 AM, at 49-year-old. The medical history included: acquired brain injury back in 2004. Concomitant medication was not reported. The patient started feeling pain in her joints by 19May2021 at 1:00 pm and feeling lethargic. The patient lied down and woke up around 6pm, between 6pm and 6:30pm her upper right side of her lip was feeling numb and weird, her speech was compromised, her left eyelid was twitching and it lasted for some time. She went back to bed to continue getting different side effects, chest pain, feeling tightness, spasms in her back, 'Nassau', and continue join pain. The speech had continued to be compromise, she had felt changes in her mood and easily irritable, continue to feel lethargic and tired. Doctor or other healthcare professional office/clinic visited. The treatment received included followed up with neurologist waiting on CT scan. Outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, a possible contributory role of vaccination with BNT162B2 to the reported events feeling lethargic, 'lip feeling numb and weird', 'speech was compromised' and chest pain cannot be excluded based on the temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-06-20 involuntary muscle movements, muscle twitching, pain in extremity around May25th she reports her legs started "twitching/jolts" and "legs hurt all the time", and "leg... Read more
around May25th she reports her legs started "twitching/jolts" and "legs hurt all the time", and "legs feeling a little weaker". She reports that after her 1st dose her legs were aching for a couple days. She was referred to medical center for a muscle test
49 2021-06-20 hot flush Havent menstruated since 09/2020. Have had hot flashes for months/years. Hot flashes ceased within c... Read more
Havent menstruated since 09/2020. Have had hot flashes for months/years. Hot flashes ceased within couple of weeks of second vaccine. Started menstruation on 6/16/2021. Flow became very heavy at times with cramping.
49 2021-06-21 concussion, feeling cold Began to feel side effects of body aches, chills, lethargy within 12 hours after 2nd Covid-19 vaccin... Read more
Began to feel side effects of body aches, chills, lethargy within 12 hours after 2nd Covid-19 vaccine. At 4am the day after the vaccine, I felt nauseated and feverish. Within seconds afer taking nausea medication, I fainted. Not sure how long I was unconscious, but there was a large pool of blood under my head and I was very cold. I managed to get back into bed and called my husband who was out of town. He called a neighbor who came and got me around 5:15 am, and took me to the emergency room. I arrived nauseated, with a headache, & bleeding from a wound above my right eyebrow. I was given a head CT scan & stitches to close my head wound. CT Scan was negative for brain trauma, but I did suffer a concussion.
49 2021-06-21 flushing, pain in extremity, tingling At about 1143 patient was placed on gurney by LVN after patient vomited in the restroom soon after ... Read more
At about 1143 patient was placed on gurney by LVN after patient vomited in the restroom soon after receiving first dose of pfizer today. Nausea was the only complain patient had along with some anxiety. Oxygen 2 litter n/c applied, vitals taken, ice pack placed on patient's forehead. Within couple of minutes patient started complain of tingling in fingers, followed by right shoulder pain, right arm pain, right side neck pain, and bone pain. Patient's face appeared flushed with increased anxiety. At about 1151 called 911. While on the phone with 911-patient started coughing, complain of throat closing, and showing some signs of respiratory distress. Subcutaneous epi pen injected to left outer thigh by RN, oxygen switched to 15 litter NB mask by RN , vitals taken. Patient continues to be responsive, able to communicate, with some shortness of breath and anxiety. Son present at bedside. supervisor and security were notified. At about 1205, fire department arrived and took over patient care. At about 1217 patient was transferred to emergency room via ambulance with son by patient's side. RN
49 2021-06-21 pain in extremity Pain in right leg. ER ruled out blood clot
49 2021-06-22 facial pain face hurt really bad; face swelled; she scared about the second shot; This is a spontaneous report f... Read more
face hurt really bad; face swelled; she scared about the second shot; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (no pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 09Feb2021 at 13:00 as 1st dose, single for covid-19 immunisation. Medical history included cancer (cancer face, had cancer removed reconstructive surgery have more procedure) from 22Jan2020 and ongoing. The patient had COVID-19 test with positive result on 14Oct2020. Concomitant medications were not reported. No known allergies. No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 09Feb2021 at 15:45, her face swelled and hurt really bad 3 hours after the shot, it had been 2 days and was feeling much better and swelling had gone down, she was scared about the second shot (second dose received on 02Mar2021 at 12:30). The events 'face swelled and hurt really bad' assessed as non-serious. The patient received diphenhydramine hydrochloride (BENADRYL), paracetamol (TYLENOL) as treatment for the events 'face swelled and hurt really bad'. Outcome for the events 'face swelled and hurt really bad' was recovered in 2021; of rest event was unknown. Information about Lot/ Batch number have been requested. Follow up (20Apr2021): Ne w information received from a contactable consumer included: medical history, lab data and reaction data (treatment details and outcome of events 'face swelled and hurt really bad' was updated from recovering to recovered). No follow-up attempts are possible; information about lot/batch number cannot be obtained.
49 2021-06-22 tingling pt. had good results from vax , had super energy , cleaned and felt like she had extreme energy . ... Read more
pt. had good results from vax , had super energy , cleaned and felt like she had extreme energy . After about 05;00 pm her energy dissipated when pt laid down heart felt like it was beating hard., only adverse event is left arm has a tingle that feels like electrical pulse that last seconds..
49 2021-06-23 slurring pt received her 1st Pfizer COVID vaccine. She was observed in the hallway feeling poorly by a volun... Read more
pt received her 1st Pfizer COVID vaccine. She was observed in the hallway feeling poorly by a volunteer. She began to have slurred speech, became diaphoretic and syncopal. She was immediately placed on a stretcher. She complained of chest tightness and difficulty breathing. Oxygen was placed on the pt and her B/P was 150/90. Pt was reported as a Type 1 diabetic on insulin. She reported having mozzarella sticks today. An ice pack was placed behind her neck and a RRT was called. Pt was in and out of coherency. Patient was monitored in ED and subsequently discharged
49 2021-06-23 feeling hot I received my 2nd dose of the Pfizer vaccination at about noon on Tuesday May 4. I went about my no... Read more
I received my 2nd dose of the Pfizer vaccination at about noon on Tuesday May 4. I went about my normal business during the day - did some errands, had a personal training session, bought groceries, and cooked dinner. I experienced a little dizziness in the hours after the injection and during the day, but nothing too disturbing. When I sat down for dinner around 8 or 9pm, I had a few sips of wine - maybe 3 ounces at most - and I immediately had a very hot feeling in my head and started hearing my heart pounding in my ears. I stopped drinking and just had dinner, and as the night progressed, I felt extremely uncomfortable. My chest felt very tight, like it was being squeezed from the inside; I had a pounding heart; my pulse was very fast; I felt very hot; and I had some difficulty breathing deeply. I also felt very agitated and not sleepy - as if I had consumed an overdose of caffeine. I watched TV until 1:30am, and I was awake in bed for several hours after that just trying to practice deep breathing and meditation. I fell asleep at some point in the early morning and woke up around 9am. By then the troubling symptoms had passed, and I was just feeling achy and extremely exhausted.
49 2021-06-23 feeling of body temperature change, weakness High Blood pressure. Fever. Swollen lymph nodes. Swollen throat. Sweating. Faint. Disoriented. Pass... Read more
High Blood pressure. Fever. Swollen lymph nodes. Swollen throat. Sweating. Faint. Disoriented. Passing out. Dizziness. Light headed. Blurred vision. Headache nausea diarrhea runny nose sore throat hot and cold feel like I have a fever. Fatigue. Bed ridden. Couldn?t lift my head off the pillow.
49 2021-06-23 numbness After an hour of vaccination numb face and brain while driving. Lasted a few seconds. Almost passed ... Read more
After an hour of vaccination numb face and brain while driving. Lasted a few seconds. Almost passed out while driving. Thereafter, vertigo. Which began after 2 weeks of vaccination.
49 2021-06-24 weakness Chest pressure/I felt like the chest was being squeezed and the chest discomfort; chest pain or pres... Read more
Chest pressure/I felt like the chest was being squeezed and the chest discomfort; chest pain or pressure like the chest is being squeezed; Tiredness/if I do exercise, I feel easier to be tired; my physical strength is not as before; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient) reported for herself. A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0171, Expiration date: Aug2021) via an unspecified route of administration, administered in left arm on 30Apr2021 (age at vaccination was 49 years) as 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. The patient stated she had a heart infection in which was not at 25 when she was in her teen years. She meant it was like 30 years ago, she had a heart infection more than 30 years ago. But she did a test, that was one couple of years ago. Doctors said her heart was fine. The heart infection was not diagnosed, it was not identified by doctor. She just didn't remember what was the name but according to symptoms, the doctors said it should be a heart infection. The patient's concomitant medications included Vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 09Apr2021 (age at vaccination was 49 years) as 1st dose, single for COVID-19 immunization and there were no reactions reported. The patient said she got the second dose of the Pfizer COVID Vaccine last 30Apr2021 and on 01May2021, the second day after 12 hours noon, she experienced side effects which is chest pain or pressure like the chest is being squeezed. After the first of few days after the second dose, she had a chest pressure, and later she had known from news that was the inflammation of chest, like something could be, like a mild 'cardioditis'. She didn't know what that was. She went to see doctor. She had it a few days after second dose. Again, chest pressure. She felt like the chest was being squeezed and the chest discomfort. And after that it had been so long. It had been one and a half month now. What she noticed was her physical strength was not as before, like when she did exercise, she used to do fine. But now if she did exercise, she felt easier to be tired. She had chest pressure and tiredness after even now so far after second dose, one and a half month now. Compared to before, her physical strength decreased. Like when she used to do exercise, she did not feel easy but now she felt easier to be tired after exercise or during exercise. She wanted to know what she should do. The patient stated that she didn't have other medical, after a few days. After like a one couple of weeks. She felt okay but she felt until now, compared before the vaccine, her physical strength, like she used to do a lot of exercise she didn't feel tired. Now it was easier to feel tired. The patient asked regarding the meaning of expiration date and whether that means she needed to get a shot again after August. The patient was informed that the product should not be used after expiration date. The patient was informed about the role of Pfizer and also informed that Pfizer Medical Information was the right department to answer the question. The patient was informed about the role of Pfizer. The patient did not receive any prior vaccinations before the Pfizer vaccine. The outcome of the events was unknown. Follow-up attempts are possible. Further information is expected.
49 2021-06-24 slurring, numbness, weakness Pt w/ allergies/intolerances to Codeine (nausea and vomiting), Gabapentin (paresthesias and numbness... Read more
Pt w/ allergies/intolerances to Codeine (nausea and vomiting), Gabapentin (paresthesias and numbness), ACEI (Cough), Ibuprofen (abdominal disorder). PMH significant for Thyroid disease, Herpes, Osteoarthritis, Obesity, Insomnia, HTN, GERD, Fibroid, Endometriosis, Depression. PSH of Gastric bypass, Oophretomy, myometomy, hysterectomy, emdometriosis fulguration, and appendectomy. Pt vaccintated at 15:50, and adverse reaction started at 16:05. After the vaccination patient c/o feeling weak, lethargic, and left side numbness (leg),lips numbness and left side of the face. Easy to arouse/ ambulate to w/c with steady gait. On exam left side weaker than right. Patient denies exertional chest pain or chest pain at rest, no exertional dyspnea. Patient denies palpitations, lightheadedness, presyncope or syncope. No rash noted. No angioedema. No sob. As per patient she had same previous reaction after Covid vaccination and as per her PCP Dr. she can take 2nd vaccination. Patient c/o only feeling sleepy and weak. VS @16:05 BP 177/115FS, HR 89 -- > @16:20 168/104, 89, 98% RA, POCT Gluc 82. Patient speak full sentences but speech delayed Called 911 @ 16:16 and RRT arrived at 16:25. Sent patient to ER via gurney @16:30 due to stroke like symptoms. Grandson with her. Nurse called family and someone will come to pick up her grandson. Pt observed in ED and released @~8pm. Current Medications: APAP 500mg 2tabs PO Q6hr PRN Pain Ca-VitD3 500mg(1250mg) 1tab PO BID Premarin 0.5g vaginally Daily PRN Diazepam 5mg PO Q8hrs PRN Anxiety Colace 100mg PO Daily Duloxetine 30mg PO Daily ergocalceiferol 1250mcg PO Qwk Flonase 1 spray each nostril daily levothyroxine 112mcg PO daily on empty stomach before breakfast Omeprazole 20mg PO BID Senna 8.6mg PO daily Tramadol 50mg PO daily Triamcinolone 0.1% cream apply to affected area BID Vitamin B complex 1tab PO daily
49 2021-06-24 numbness, tingling she "has numbness" and "tingling"in her left and right hands; It feels like pins and needles/tinglin... Read more
she "has numbness" and "tingling"in her left and right hands; It feels like pins and needles/tingling in her left and right hands; This is a spontaneous report received from a contactable consumer (patient herself) via Medical Information Team. A 49-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 14Jun2021 as 2nd dose, single (at the age of 49-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single for COVID-19 immunization and had no reaction. Patient received her 2nd Pfizer vaccine a day before (14Jun2021) and stated today (15Jun2021) she had numbness and tingling in her left and right hands, but mostly in her right hand. It felt like pins and needles, like when you leave your arm or leg in a position too long. The outcome of the events was unknown. Follow up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-06-24 numbness I have numbness in my leg; I started feeling the numbness even more; I have been tired; This is a sp... Read more
I have numbness in my leg; I started feeling the numbness even more; I have been tired; This is a spontaneous report from a contactable consumer(patient). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0217; NDC number, UPC number and expiry date were reported as unknown) via intramuscularly on 16Jun2021 at 18:45 in left arm as a single dose for Covid-19 immunization. Medical history included latex allergy from an unknown date and unknown if ongoing. Concomitant medications included fluticasone propionate (FLONASE ALLERGY RELIEF); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); losartan (LOSARTAN) and carvedilol (CARVEDILOL) all taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine, Formulation: Solution for injection lot number: EW0187) via intramuscularly on 26May2021 at 13:00 in left arm for COVID-19 immunization. The patient did not receive any prior vaccination within 4 weeks. After the second dose the patient she started feeling numbness (today) 17Jun2021 (at 04:00) at work and even more and started feeling the numbness even more its just kind of in her way. The patient was tired after she received the vaccine. She wanted to know where she can report the side effects as she had read about the symptoms of the vaccine which she didn't came across. The patient reported her brother received both the doses of vaccine and he was fine. He did not experience anything. Investigation assessment was not reported. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-06-24 numbness I have numbness in my leg; I have been tired; This is a spontaneous report form a contactable consum... Read more
I have numbness in my leg; I have been tired; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0187, Expiration date: unknown) intramuscular, administered in upper left arm on 26May2021 at 13:00 pm (age at vaccination was 49 years) as 1st dose, single for COVID-19 immunization. Medical history included latex allergy from an unknown date. Concomitant medications included fluticasone propionate (FLONASE) (Nasal spray) taken for hypersensitivity, hydrochlorothiazide, losartan and carvedilol taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was Pharmacy store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to know where she could report the symptoms because what she read, the little she read about the symptoms of the vaccine she didn't came across it. So she had got both of the vaccine. On 30May2021, the patient experienced numbness in her leg. She had been tired after she received the vaccine so she wondered with whom she needs to speak with for the side effect. The numbness after the first shot she though it was about on the fourth day. She started feeling the numbness even more it was just kind of in her way. She confirmed Pfizer Covid-19 Vaccine. She was informed about the role of Pfizer drug safety. She stated that her brother actually got his shot the following day after her so the first dose he got on the Thursday and the second dose yesterday and he was fine. He did not experience anything. The outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.
49 2021-06-24 pain in extremity Muscle pain - all muscle areas; Chills; Fever; Loss of appetite; Nausea; Pain in the arm; Pain all o... Read more
Muscle pain - all muscle areas; Chills; Fever; Loss of appetite; Nausea; Pain in the arm; Pain all over body; Tiredness; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in left arm on 13Mar2021 at 09:00 (at the age of 49- year-old) as a single dose for COVID-19 immunisation. Medical history included dysfibrinogenemia. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in left arm on 19Feb2021 at 14:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. On 13Mar2021 at 13:00, the patient had pain in arm, pain all over body, tiredness, headaches, muscle pain- all muscle areas, chills, fever, loss of appetite and nausea. Therapeutic measures were taken as a result of events pain in arm, pain all over body, tiredness, headaches, muscle pain- all muscle areas, chills, fever, loss of appetite and nausea and included treatment with tylenol on day 2 after the second dose. The clinical outcome of events pain in arm, pain all over body, tiredness, headaches, muscle pain- all muscle areas, chills, fever, loss of appetite and nausea was recovered on an unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.
49 2021-06-24 tingling Patient reported mild tingling in her leg and face, which lasted for a few minutes (unknown time cou... Read more
Patient reported mild tingling in her leg and face, which lasted for a few minutes (unknown time course). Denied any swelling of the face, swelling of the tongue, rash, itching, cough, shortness of breath or chest tightness.
49 2021-06-24 tenderness, nerve pain I was diagnosed with Shingles on 11-JUN-2021 after presenting with nerve pain and blistering rash on... Read more
I was diagnosed with Shingles on 11-JUN-2021 after presenting with nerve pain and blistering rash on back and front left shoulder and left and back of the neck. 22-MAY-2021: Itchiness and red blotchiness appeared on left front chest and shoulder. Lasted for several hours and then resolved. No doctor contacted. 31-MAY-2021: 2nd round of itchiness on front left shoulder and left side neck. Lasted several hours and resolved itself. No doctor contacted. 07-JUN-2021: Left front and back shoulder was sore to the touch, hot like a sunburn, and tight muscle pain thru shoulder and left neck. 08-JUN-2021: Symptoms worsened throughout day and then nerve pain was present during the night thru left shoulder and left side and back of the neck. 09-JUN-2021: Had a teladoc doctor visit about severe shoulder/neck pain. Pain medicine was prescribed and instructed to see PCP if symptoms did not resolve. Small bumps appeared on left back shoulder as if bitten by a bug. 10-JUN-2021: Shoulder/neck pain still present and took motrin every 4 hours for pain. Used heat pad for pain. More bumps appeared on front left chest and back left shoulder. 11-JUN-2021: Rash worsened with blisters forming and spreading further on left chest and shoulder and up left and back of the neck. Pain was still present. Teladoc was called again and shown pictures of rash. Diagnosed with Shingles and prescribed Valtrex. 12-17-JUN-2021: Pain and rash still present with ice pick headaches occurring every few seconds many times a day. 18-JUN-2021 to present: Rash and pain began to recover but still present to date.
49 2021-06-26 pain in extremity Took the 2nd dose at 8.15 am. Around 10 pm (14 hrs after the shot) my arm hurts and I felt extremely... Read more
Took the 2nd dose at 8.15 am. Around 10 pm (14 hrs after the shot) my arm hurts and I felt extremely chilled. Around 11 pm my temperature went up from 98.7 or 99.7. I took Tylenol flu and cold medicine, went to sleep. Woke up at 2 am, fever was gone. The next day in the afternoon, I felt tired and took a nap.
49 2021-06-27 migraine Intense pain at injection site & entire upper arm/shoulder down to elbow lasting 4-5 days. Low-grade... Read more
Intense pain at injection site & entire upper arm/shoulder down to elbow lasting 4-5 days. Low-grade fever, constant chills, whole body aches, muscle soreness everywhere, extreme fatigue, near-migraine headache, bad diarrhea, nausea, dehydrated?all started night of 1st vaccine & got worse over next couple of days. Then a lupus/RA flare occurred because of that & I was very sick in bed for a week+. Took 2 full weeks to recover. Drs/vaccination providers shouldn?t be telling people to take their immunosuppressant meds on same day of vaccination?I almost ended up in the hospital!
49 2021-06-27 muscle spasms, weakness Severe epigastric pain, nausea, diarrhea, abdominal pain, body aches, muscle spasms, weakness,
49 2021-06-28 facial paralysis FACIAL DROOP E87.1 - Hyponatremia
49 2021-06-28 pain in extremity Developed pain in opposite arm that then turned into muscle weakness and limited mobility. This has ... Read more
Developed pain in opposite arm that then turned into muscle weakness and limited mobility. This has radiated to the other arm. Was diagnosed with Brachial Neuritis.
49 2021-06-29 weakness Raised, hot, hard, itchy bump at injection site one week post vaccine.; Weakness; Arthritis in left ... Read more
Raised, hot, hard, itchy bump at injection site one week post vaccine.; Weakness; Arthritis in left hand; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 09:00 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included psoriasis. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to COVID vaccination. On 20Mar2021 at 23:00, the patient experienced raised, hot, hard, itchy bump at injection site one week post vaccine (vaccination site reactions) and weakness (asthenia) or arthritis in the left hand. The treatment received for the adverse event was unknown. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site reactions, asthenia and arthritis were not resolved at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
49 2021-06-29 breast pain The afternoon after I got the second dose of the vaccine I started to have pain under my arm and alo... Read more
The afternoon after I got the second dose of the vaccine I started to have pain under my arm and along the left side of of my breast. It got more intense overnight and the next day. It started to localize in my underarm area. It was painful to put my arm down. It lasted for a week as intense pain and then it started to resolve. By ten days after the shot it was not painful. I was using ice three times daily and taking pain relievers. Currently the problem has resolved.
49 2021-06-29 feeling hot PATIENT DEVELOPED HOTNESS ALL OVER AND A HEADACHE AND AN INCHREASE IN BP. PATIENT DID NOT WANT EMS ... Read more
PATIENT DEVELOPED HOTNESS ALL OVER AND A HEADACHE AND AN INCHREASE IN BP. PATIENT DID NOT WANT EMS CALLED AND HAD HER HUSBAND DRIVE HER HOME I ADVIZED HER HUSBAND TO KEEP AN EYE ON HER AND IF HER SYMPTOMS CONTINUED TO CONTACT HER PRIMARY DOCTOR OR AND IF THEY GET WORSE TO CALL EMS.
49 2021-06-29 migraine Migraine; period started 2 days early the day after the shot and slightly heavier bleeding than usua... Read more
Migraine; period started 2 days early the day after the shot and slightly heavier bleeding than usual.; Headache; Fatigue; Mild fever of 99.9; Tenderness of lymph node under left arm; swelling and tenderness of lymph node; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in left arm on 22Apr2021 at 11:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included ZYRTEC and PRILOSEC for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in left arm on 01Apr2021 at 10:45 (at the age of 48-years-old) as a single dose, for COVID-19 immunisation. On 23Apr2021 the body temperature was measured and was found to be 99.9 (unspecified unit). On 23Apr2021 at 07:00 the patient experienced mild fever of 99.9 (unspecified unit), fatigue, swelling, tenderness of lymph node under left arm (lymph node tenderness) and headache. On the same day the patient also reported that period started 2 days early the day after the shot and slightly heavier bleeding (bleeding menstrual heavy) than usual. On 25Apr2021 3 days after the shot the patient had experienced migraine. The clinical outcome of events lymph node tenderness, swelling, bleeding menstrual heavy, headache, pyrexia, fatigue was recovered on an unspecified date in Apr2021; while that of the event migraine was unknown. No follow-up attempts are needed. No further information is expected.
49 2021-06-29 muscle twitching I had twitching
49 2021-06-29 pain in extremity Chills; Headache; Muscles hurt; Face swollen; Hands swollen; It hurts to walk; This is a spontaneous... Read more
Chills; Headache; Muscles hurt; Face swollen; Hands swollen; It hurts to walk; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in left arm on 19Mar2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. It was reported that the patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications (unspecified) were taken within two weeks of vaccination. On 19Mar2021 at 22:00, the patient experienced chills, headache, muscles hurt, hands and face swollen and hurts to walk. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, headache, muscles hurt, hands and face swollen and hurts to walk were not recovered at the time of this report. Information about lot number cannot be obtained. No further information is expected.
49 2021-06-29 pain in extremity heaviness; lethargy; Soreness in arm; soreness in hips; This is a spontaneous report from contactabl... Read more
heaviness; lethargy; Soreness in arm; soreness in hips; This is a spontaneous report from contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 18Mar2021 at 19:15 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history and was allergic to penicillin. The concomitant medications included MULTIVITAMIN, VITAMIN C, OSTEO BI FLEX, calcium (MANUFACTURER UNKNOWN), VITAMIN E for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 06:00, the patient experienced soreness in arm, heaviness in arm, lethargy, soreness in hips. No therapeutic measures were taken for the reported events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of soreness in arm, heaviness in arm, lethargy, soreness in hips was not resolved at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
49 2021-06-30 feeling hot face, neck, ear, chest, and shoulder turned red.; Skin Rash; Rash areasfelt hot; This is a spontaneo... Read more
face, neck, ear, chest, and shoulder turned red.; Skin Rash; Rash areasfelt hot; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 23Mar2021 at 12:45 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient medical history included Hashimotos, Sjogrens syndrome (Sjogrens), systemic lupus erythematosus (Lupus), and polymorphous disorder. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was allergic to morphine, prednisone and some antibiotics(unspecified). Concomitant medications included levothyroxine (25mg) (MANUFACTURER UNKNOWN), sertraline (25mg) (MANUFACTURER UNKNOWN) for unknown indications and from an unknown date. The patient also received ADVIL 2 days before the vaccination on 21Mar2021. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 12:45, within a couple of minutes of vaccination patients face, neck, ear, chest, and shoulder turned red. The patient developed rash in some areas and also felt hot in those areas. It was reported that this lasted an hour at that severity and when it started to improve, patient left home. The areas were red but not as bright and they didnt feel as hot. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events skin red and rash was not recovered; while that of the event hot feeling was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-06-30 hot flush, migraine, cold sweat Hot flashes04/26/2021, cold sweat04/26/2021, joint pain04/26/2021, migraine 04/30/2021
49 2021-06-30 numbness Started to feel minor pain on right wrist, the outside joint bone; Numb sensation through the outsid... Read more
Started to feel minor pain on right wrist, the outside joint bone; Numb sensation through the outside rim of right palm as well; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 18Mar2021 at 14:58 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Mar2021 at 08:00, the patient experienced minor pain on right wrist, the outside joint bone. When the patient washed hands, could feel the numb sensation through the outside rim of right palm as well. The bone pain persisted from 19Mar2021 to present day, 23Mar2021. The numbness on outside rim of palm also persisted. On a scale from 1- 10, the pain was assessed as 1 or 2, minor pain and the numbness was about the same category. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events wrist pain and numbness in hands was not recovered at the time of this report. Information on the lot/batch number has been requested.
49 2021-06-30 night sweats Had a CT chest which revealed pleural effusion, and pericardial effusion.; Had a CT chest which reve... Read more
Had a CT chest which revealed pleural effusion, and pericardial effusion.; Had a CT chest which revealed pleural effusion, and pericardial effusion.; I started having left-sided chest pains.; chills; night sweats; I had an increase in joint pains.; This is a spontaneous report from a contactable consumer reported herself. A 50-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19, Solution for Injection, Lot number: ELO140), via an intramuscular route on left arm 21Dec2020 at 13:00, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. the patient does not have any medical illness. No known allergies have been reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On an unknown date, during the month of December, after taking the first covid shot, patient experienced an increase in joint pains which continued throughout the month of January. In Feb2021, she started having chills at sundown with night sweats. But no fever, no cough. On 28May2021 at 15:00, she started having left-sided chest pains. No cough, no fever, no chills. On 03Jun2021, patient went to the emergency room at work and had a CT chest which revealed pleural effusion, and pericardial effusion. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included admission to emergency room/department or urgent care for 3 days and received IV Doxycycline, IV Rocephin, Toradol, Losartan, Pepcid and Colchine. On an unknown date, patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19, Solution for Injection, Lot number: EL 3302) on the left arm as a single dose for covid-19 immunization. The patient underwent lab test and procedure which included post vaccination covid tests, nasal swab rapid test on 03Jun2021, test result: negative and covid PCR test on 04Jun2021, test result: negative. The clinical outcome of the events was recovered on an unknown date. Information on batch/lot numbers are available. Further information has been requested.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-07-01 muscle spasms I have had muscle cramps, fevers, fatigue, headache, cough, shortness of breath , aches and pains ... Read more
I have had muscle cramps, fevers, fatigue, headache, cough, shortness of breath , aches and pains whole body, stomach pain, nausea, unable to sleep long periods. Taste and smell issues, itchy hives, swollen itchy eyes, swollen lower extremities.
49 2021-07-01 pain in extremity fever shot to 103; Vomiting; Headache; Body pain; Arm swoll to double its size from shoulder to elbo... Read more
fever shot to 103; Vomiting; Headache; Body pain; Arm swoll to double its size from shoulder to elbow; Pain in my feet; Broke blood vessels in my upper body; Dry heaving.; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unknown route of administration on right arm the 20Mar2021 at 10:15 (age at vaccination 49-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient received unspecified medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took VIOXX, LEVEQUIN and DEMEROL; developed allergy for all the drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 10:30 (within 15 minutes), the patient experienced nausea, overwhelming headache, body pain, right arm was swollen to double its size from shoulder to elbow and the patient broke her blood vessels in upper body from dry heaving. At 11:00, nausea led to vomiting and the patient could not hold any liquids. At 12:30, the patient had fever 103 (units unspecified). The events of vomiting and nausea were debilitating for the next 24 hours and patient's overall body pain became unbearable. The major effects lasted more than 24 hours. On an unknown date in Mar2021 (72 hours after vaccination), the patient was still feeling nauseated, body pain was still off and on, and patient felt she was having flu at that point and stated first 24 hours was a nightmare. Therapeutic measures taken as results of events and included treatment with BENEDRYL or TYLENOL, but she couldn't hold down anything. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of events nausea, vomiting, headache, body pain, arm swollen, pain in feet, fever, Injury to blood vessel of head and neck and dry heaves were recovered with sequalae on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected.
49 2021-07-02 burning sensation, feeling cold No voice; I got very sick; Body aches; Teeth and gums hurt; Teeth and gums hurt; Face burns; Freezin... Read more
No voice; I got very sick; Body aches; Teeth and gums hurt; Teeth and gums hurt; Face burns; Freezing chills; Cough; Extreme fatigue; Sore throat; Headache; Abdominal pain; Nausea; Diarrhea; Laryngitis; Lungs burn; This is a spontaneous report from a contactable consumer. A 49-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in arm left on 14Apr2021 at 13:00 as second dose (at the age of 49-year-old) for covid-19 immunisation. The patient's medical history included hypertension and allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. Previously patient took first dose of bnt162b2 (Lot number unknown) via an unspecified route of administration in left arm on24Mar2021 at 13:00 PM for covid-19 immunisation and had no reaction. On 15Apr2021 at 13:00 (PM), the patient experienced no voice, very sick, body aches, teeth and gums hurt, face burns, freezing chills, cough, lungs burn, extreme fatigue, sore throat, headache, abdominal pain, nausea, diarrhea and laryngitis. Patient received the treatment of tylenol, dayquil, in bed for two days. The outcome of events was resolving. Information on lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event fatigue, headache, nausea, diarrhea, chill and the suspect drug BNT162B2. Also, as there is limited information in the case provided, the causal association between the events aphonia, sickness, general body pain, teething pain, gum pain, burning sensation in face, cough, painful respiration, sore throat, abdominal pain, laryngitis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-07-02 involuntary muscle movements, tingling, tremor Felt sensation of tightness in chest or fast heartbeat; Felt sensation of tightness in chest or fast... Read more
Felt sensation of tightness in chest or fast heartbeat; Felt sensation of tightness in chest or fast heartbeat; Shaking hands; Tingling forearms; Jerking movement in hands; Looked like a parkinson's patient; Brief tingling in lips; Sharp pain in mid back; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in arm right on 19Apr2021 at 12:45 (at an age of 49-years-old) as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Medical history included asthma, sulphonamide allergy and morphine allergy. The patient's concomitant medications were not reported. Patient not diagnosed with covid-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. On 19Apr2021, about 2 minutes after shot the patient experienced shaking hands, tingling forearms, jerking movement in hands looked like a Parkinson's patient. Brief tingling in lips, felt sensation of tightness in chest or fast heartbeat like having had lots of coffee. Sharp pain in mid back this was all very dramatic and fast but disappeared fully within an hour No problems at all overnight or the next day. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events was recovered on unspecified date in 2021. Follow-up attempts are needed. Further information is requested.
49 2021-07-04 tingling, numbness Numbness and tingling of the face. Racing heartbeat. Mental Confusion. Patient went to ER and was gi... Read more
Numbness and tingling of the face. Racing heartbeat. Mental Confusion. Patient went to ER and was given Benadryl after which the symptoms remitted.
49 2021-07-05 tingling tingling sensation along recent surgical incision and along both sides; Burning pain down left leg f... Read more
tingling sensation along recent surgical incision and along both sides; Burning pain down left leg from knee to foot; This is a spontaneous report from non-contactable or other healthcare professional. A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration on 17Mar2021 (at the age of 49 years old) as a single dose for COVID-19 immunization. Medical history includes full knee replacement on 09Mar2021. Concomitant drugs include were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. On 17Mar2021 after 15minutes waiting period of the vaccination, the patient experienced tingling sensation along recent surgical incision and along both sides, and burning pain down left leg from knee to foot. The patient did not receive treatment for the reported event. The left knee was bandaged, wrapped with ace bandage and also had compression socks on. The clinical outcome of tingling sensation and burning pain was unknown. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: patient's name and country added in patient tab; and Treatment Received ticked Yes.
49 2021-07-06 weakness, pain in extremity memory loss; sweats; she got sick on April 7th; Experienced severe flu like symptoms; dizziness; bod... Read more
memory loss; sweats; she got sick on April 7th; Experienced severe flu like symptoms; dizziness; body aches; sleeping all the time; bone aches; tired; chills; fever; She was very weak; A few days after the same arm where she got the vaccine developed carpel tunnel pain that has continued to last for 3 months.; brachial neuritis; A few days after the same arm where she got the vaccine developed carpel tunnel pain that has continued to last for 3 months.; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EP7534), dose 1 via an unspecified route of administration, administered on Arm Left on 20Mar2021 (age at vaccination: 49 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing hypothyroidism Diagnosed in her early 20s, over 25 plus years ago. She stated that she does not take medication, except Excedrin if she has a headache. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing. On an unspecified date in Mar2021, the patient experienced a few days after the same arm where she got the vaccine developed carpel tunnel pain that has continued to last for 3 months and her arm is still sore today and is still very difficult for her to wear clothes and do things. On an unspecified date, she experienced memory loss and the first week after the shot she does not remember. On an unspecified date in Apr2021, the patient experienced She was very weak. Pain was described as shooting up her arm starting with the hand and wrist. On 07Apr2021, the patient got sick after receiving her first dose of the vaccine and experienced severe symptoms very close to COVID symptoms and experienced severe flu like symptoms, chills, sweats, Dizzy, fever, body aches, aching, sleeping all the time, bone aches, couldn't carry herself. Her body was really tired and Her whole body was falling apart and sitting on the couch all day. Due to this sickness her HCP advised she wait 90 days before receiving her second dose of the Pfizer BioNtech covid 19 vaccine on 11Apr2021.The patient inquired if other patients who received the Pfizer BioNtech covid 19 vaccine also experienced nerve pain as per described in hand/arm and if this could potentially by brachial neuritis. Response provided as "New or worsened joint pain" in reference to nerve pain specifically. The patient wanted information on why individuals with hypothyroidism were not included in the clinical trials for the Pfizer BioNtech covid 19 vaccine. The latest test she did was the antibodies test and it was positive, and she is not sure why, if this was due to the first shot or because she actually had COVID. Her doctors don't know, nobody knows. She was told to wait 90 days after the antibodies test to take the second shot. However, she was looking and reading and was wondering if this was applicable to her. The people who should wait 90 days are the people who were treated with antibodies when they had COVID with plasma. She didn't have COVID and did not get treated with antibodies. She is also wondering if she should start over and take shots one and two again. or should she take antibodies before and just take shot number 2. She stated her other problem is that she got sick from the side effects. She has never ever had this type of cold or flu. Since receiving the shot she has had an issue with the arm she received the shot in, her left arm. The nerves of her arm. She states her whole arm isn't functioning. All of the sudden she started having carpal tunnel and shooting pains. Nothing is back to normal. She has completely recovered. It took a month and half or 2 for her to get back to normal activities. She has been reading about brachial neurosis, caused by vaccines that have caused damage to nerves in her arm and hand. Nobody knows what is wrong with her arm. She is experiencing carpal tunnel in her hand and up to her shoulder. The patient underwent lab tests and procedures which included antibody test: positive on 19Apr2021, magnetic resonance imaging: unknown on an unknown date, sars-cov-2 test: negative on 10Apr2021, sars-cov-2 test: negative on 12Apr2021, sars-cov-2 test (Rapid): negative on 08Apr2021.Therapeutic measures were taken as a result of a few days after the same arm where she got the vaccine developed carpel tunnel pain that has continued to last for 3 months and included muscle relaxer that did not make the pain go away. Was referred to an orthopedic doctor for an MRI to further evaluate. The outcome of the event carpel tunnel pain, She was very weak was not recovered, Events she got sick, Experienced severe flu like symptoms, body aches, sleeping all the time, chills, sweats, fever, tired, bone aches was recovered on an unspecified date, while event memory loss was unknown. Follow up attempt is excepted. Further information is requested.
49 2021-07-06 pain in extremity shortness of breath; irregular heart beat; palpitations; EKG did show PVC's; HCP at the urgent care ... Read more
shortness of breath; irregular heart beat; palpitations; EKG did show PVC's; HCP at the urgent care was concerned about the T wave being peaked; left arm was sore; This is a spontaneous report from a contactable nurse practitioner (patient). A 49-year-old female patient received first dose bnt162b2(age at vaccination was 49 years) (BNT162B2, Solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration, in Arm Left on 12May2021 11:00 (at the age of 49years) as 1ST DOSE, SINGLE for covid-19 immunisation (reason: Civic Duty, wanting to be protected in a pandemic). Patient didn't receive other vaccination with in 4weeks prior to covid-19 vaccination patient received other products valsartan prior to vaccination. Medical history included ongoing high blood pressure (diagnosed about 2 years ago; high blood pressure related to PTSD), PTSD and palpitations (several years ago she had palpitations, but they were rare, and she wore a Holter monitor). Investigation assessment was done. Concomitant medications included valsartan (started 2 years ago, as needed) taken for high blood pressure (valsartan bottle was so small, she didn't know if she will be able to see it. Valsartan 80mg tablets). History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks, no adverse events following prior vaccinations. Family medical history included dad was very sensitive to medications, she thought she will likely be following in his footsteps. The patient was calling to report her side effects or adverse reactions. On 12May2021, her left arm was sore, and then when she woke up on 13May2021 (around 7:00), she had shortness of breath, palpations and irregular heartbeat. Seriousness for shortness of breath, palpations and irregular heartbeat was assessed medically significant by reporter. The patient was supposed to play pickle ball, she was very active and didn't think that was a good idea with her side effects, so she went to the urgent care and emergency care (ER) on 13May2021 (last evening) and was evaluated at Urgent Care and ER. On 13May2021, testing included urgent care electrocardiogram (EKG), which showed PVCs and they were concerned about the T wave being peaked. On 13May2021, chest x-ray, CBC, chemistry panel, PT INR, troponin, d-dimer, PTT, urinalysis, glucose and pregnancy test, all results came back normal. She had a follow up with Cardiology next week for palpitations, irregular heart rate, and shortness of breath. The patient didn't take her supplements on 14May2021 (today), yesterday or the day before (starting 12May2021) because she didn't want them to react with anything and she hadn't taken her valsartan on 14May2021 (this morning yet). The patient stated several years ago she had palpitations, but they were rare, and she wore a Holter monitor, and she had not had them in several years. The patient will speak with her Cardiologist about the second vaccine and said no offense, but her family practice was a nurse practitioner and since her side effects were cardiac related, she will talk with him. The patient saw him last week on 05May2021. The patient was on the losartan as needed, but her blood pressure was not usually too high and it was dropping her blood pressure too low, so she reduced it to 40mg daily instead of 80mg as needed but last week he started her on it daily. The patient said she knew the vaccine was under emergency use, so she wanted to call and report to help provide data. The patient was hoping to get the shingles vaccine in July when she was eligible, as long as there was no interaction with the Covid vaccine. The patient had concerns about getting the second vaccine. The outcome of the events dyspnoea, heart rate irregular, palpitations, pain in extremity all had was recovered on 14May2021, outcome of the events ventricular extra systoles, electrocardiogram t wave peaked was unknown. Verbatim event relatedness: Covid 19 Vaccine: didn't take her supplements today, yesterday or the day before because she didn't want them to react with anything - Related; Covid 19 Vaccine: Irregular Heartbeat - Related; Covid 19 Vaccine: Sore Left Arm – Related. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events dyspnea, palpitation and heart rate irregular and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-07-06 tremor Temperature of 101.7 initially, tremors, headache, nausea, dizziness, diarrhea, extreme lethargy.... Read more
Temperature of 101.7 initially, tremors, headache, nausea, dizziness, diarrhea, extreme lethargy. Lasting for 48 hours.
49 2021-07-07 pain in extremity continuous pain in arm 2 days after shot, cant move swollen red mark on arm wont go away cant sleep
49 2021-07-08 slurring fatigue, confusion, slurred speech, heart fluttering, shortness of breath. The concerning side effe... Read more
fatigue, confusion, slurred speech, heart fluttering, shortness of breath. The concerning side effect, which has continued, is the shortness of breath. It feels like when I had pericarditis years ago.
49 2021-07-08 hot flush Patient reported 1.5 month history of daily, intermittent hot flashes that started 1 week after rece... Read more
Patient reported 1.5 month history of daily, intermittent hot flashes that started 1 week after receiving the first Pfizer COVID-19 vaccine. She was having regular menses every 25 days, but did not have a period for 3 months after the vaccine.
49 2021-07-08 pain in extremity This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnan... Read more
This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 24Mar2021 at 10:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included birth control medications, herbal and dietary supplements; all for unknown indications from unknown date. The patient previously received tetracycline and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 24Mar2021 at 11:00, the patient experienced some headache and in night, the patient's upper arm and surrounding area was sore. On 25Mar2021, the day after the vaccination, the patient's arm was bit swollen and she had chills but doesn't show up as a fever. The patient reported that she did not seem to have headaches but felt that she was on a verge of getting a fever. The patient did not receive any treatment for the reported events. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events headache, upper arm and surrounding area was sore, swollen arm and chills were resolving. No follow-up attempts are possible. No further information is expected.
49 2021-07-10 feeling hot, pain in extremity, flushing, tingling tingle in left hand; felt hot; her face was flushed; her lip started to swell with a little bit of r... Read more
tingle in left hand; felt hot; her face was flushed; her lip started to swell with a little bit of redness above the right side of her lip; her arm was sore too; touched her lip and it felt numb; This is a spontaneous report from a contactable consumer or other non hcp. A 49-year-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration in Arm Left on 07Mar2021 16:30 as dose 1, single for covid-19 immunisation (at hospital). patient didn't received other mediations within 4 weeks prior to vaccination patient didn't had any illness prior to vaccination. Medical history included food allergy shellfish allergy from an unknown date and unknown if ongoing. The concomitant medications were not reported. On 07Mar2021 the patient experienced tingle in left hand, felt hot, her face was flushed, her lip started to swell with a little bit of redness above the right side of her lip, her arm was sore too, touched her lip and it felt numb. Therapeutic measures were taken for the events Benadryl was prescribed by physician. She would be planning to receive her second dose on26MAR2021 No relevant tests were reported. The outcome of the events paraesthesia, feeling hot, flushing, lip swelling, pain in extremity, hypoaesthesia oral was recovered. No follow-up attempts are possible. No further information is expected.
49 2021-07-11 pain in extremity About 2 hours after vaccine I had a fever, chills, and upset stomach. Arm was in extreme pain. This ... Read more
About 2 hours after vaccine I had a fever, chills, and upset stomach. Arm was in extreme pain. This lasted 3 days. About maybe 5 days later got a rash on my hip. Didn't think much of it. The rash came and went in different parts of my body. Went to urgent care on 6/5/21. I was given a steroid cream went home and proceeded to use that on my rash I would use it it would go away and a day or two later it will come back in a different spot. So I ended up doing a phone visit with on 6/9/21. He gave me another steroid cream which did the same thing the first one did. Had a second appointment with same doctor and he prescribed Permethrin. I knew that was the wrong diagnosis but I use the cream anyways but no results of making me better. Nothing was taken away this rash so I went back to Urgent Care on 07/05/2021. I sat with the doctor and we went through everything we could possibly imagine. I have been a creature of habit my entire life I do not eat new foods I do not change anything in my lifestyle I am osidea so I've always repeated the same things for over 30 years nothing new introduced to me I got the flu shot yearly so I assumed this would be okay this is the only thing new that has been in my body so the doctor had concluded that I probably had shingles due to the covid vaccine I am taking the antibiotics and still have the extreme rash I'm almost done with antibiotics and if I still have it I'm going to the emergency room and that's all I have for now
49 2021-07-12 numbness, tingling Left side of body (the side of the body of the injection site) numbness, pain, and tingling on my Fa... Read more
Left side of body (the side of the body of the injection site) numbness, pain, and tingling on my Face, Arm, Neck, back, foot and leg. These symptoms have been present every day since the injection 7-3-2021 to current (7-13-2021)
49 2021-07-12 muscle spasms, weakness Had soreness at injection site, fatigue, weaker muscle cramps and headache, anemic.
49 2021-07-12 cold extremities, pain in extremity, muscle spasms, numbness, feeling hot numbness at times; crampy toes; Couldnt sleep; abdominal pain; Pain on back; pain at both legs; pain... Read more
numbness at times; crampy toes; Couldnt sleep; abdominal pain; Pain on back; pain at both legs; pain at both arms; headache; very hot upper body; very cold feet; nauseated; shooting pain on legs; felt like excruciated pain on everybone especially night of vaccinatedday; very shaky feeling; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 49 years) at 09:00 as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient was allergic to vancomycin and celecoxib. Concomitant medications included, mesalazine (LIALDA), omeprazole (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), budesonide (UCERIS) (MANUFUCTURER UNKNOWN) for unknown indications. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination the patient had not been tested for COVID-19. since the vaccination, the patient had not tested for COVID-19. On 23Mar2021 at 17:00, the patient experienced, pain on back (all along spine) through both legs and both arms along with very bad abdominal pain (as if it will burst anytime soon) pain on head (explosive feeling), very hot upper body and very cold feet and nauseated, shooting pain on side of both legs, it felt like excruciated pain on every bone especially night of vaccinated day, day after and the third day that was on 26Mar2021, the patient couldn't sleep or moved around and felt very shaky after the third day, still had bad back pain, pain on right leg and right arm (numbness at times), crampy toes can't sit as before the vaccination. The adverse event had not resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events back pain, leg and arm pain, abdominal pain, headache, hot feeling, sleep loss, cold feet, nausea, shooting pain on legs, bone pain, shaky feeling, numbness and crampy toes were not recovered. No follow-up attempts are needed. No further information is expected.
49 2021-07-12 seizure like phenomena, numbness, electric shock sensation This is a continuation from report on 4/9 my symptoms has worsened. Since the vaccine I've exp paras... Read more
This is a continuation from report on 4/9 my symptoms has worsened. Since the vaccine I've exp paraseizures everywhere (hands, feet,etc.). At times it feels like electricity going through my body. My right leg started exp heaviness and numbness. When I'm sitting my feet will feel as if there falling asleep.My mouth, tongue, and lips feel numb sometimes too.
49 2021-07-12 tremor Malaise; body aches; muscle stiffness/ body stiffness; high fever of 102.8; chills; shaking; sweatin... Read more
Malaise; body aches; muscle stiffness/ body stiffness; high fever of 102.8; chills; shaking; sweating; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in right arm on 27Mar2021 at 17:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hashimotos hypothyroid, congenital heart malformation, obesity and glaucoma. The patient had allergies to sulfa, TEGRETOL, TRILEPTAL and bee stings. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL), all for unknown indications and received within 2 weeks of vaccination. The patient previously received first dose for BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in left arm on 06Mar2021 at 16:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks of COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 19:30, the patient experienced malaise, body aches, muscle stiffness. It was reported that, progressed to high fever of 102.8, chills, shaking, malaise, sweating, and all over body stiffness and aches for the next 24 hours. It was reported that she had sore and stiff till 29Mar2021 and the fever was gone down. On 27Mar2021, the patient underwent body temperature measurement and the result was 102.8 (unspecified units). The patient did not receive any treatment for the events. The clinical outcome of the events malaise, body aches, muscle stiffness, fever, chills, shaking and sweating was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-07-13 weakness, feeling hot Came in for dose #2 of Pfizer Covid19 vaccine, reports severe allergy type reaction to dose #1. Sta... Read more
Came in for dose #2 of Pfizer Covid19 vaccine, reports severe allergy type reaction to dose #1. States waited 15 minutes in office after vaccination #1 then walked to her car. When arrived at her car, felt "heat" and "fullness" swelling of throat, chest, upper airway. States had fast heartbeat and severe dizziness and weakness, spinning. Denies rash, itching or hives or difficulty breathing. Because she was able to breathe, she stated she decided not to return to the hospital, went home. States resolved on its own, dizziness lasted into the next day. Per fact sheet for Recipients and Caregivers, this describes a severe allergic reaction to previous dose of Pfizer vaccine and dose #2 is contra-indicated. Discussed at length. Verbalizes understanding.
49 2021-07-13 weakness, numbness May not be related but I'm not a fan of "coincidence". 8-10 hours after 2nd shot, right pinky & ring... Read more
May not be related but I'm not a fan of "coincidence". 8-10 hours after 2nd shot, right pinky & ring finger started feeling numb and not moving normally. The next morning, those 2 fingers were completely numb and I could not type or write. The following day, I could feel those 2 fingers but they would not move normally. There was also a loss of strength such that I was unable to expand my fingers -- such as what you do when opening a pair of closed scissors. I had to move those 2 fingers with my other hand if I wanted to expand them. During the following week, the symptoms improved slowly. By week #2, I could type again but still had some weakness and my hand, wrist, arm tired easily. At the 3 week mark, I saw an Orthopedic specialist (because I made the appointment the day I couldn't move my fingers) and he had no real explanation. He said the symptoms I described normally progress the opposite way...starting subtle and progressing to loss of hand/finger function. Starting with loss of hand/finger function and then it getting better slowly was not something he had seen. No real treatment or known cause of the problem. The Orthopedic specialist told me to wear a brace and call if it happens again.
49 2021-07-13 weakness By nighttime the day of the shot I had developed a fever of 103, strong chills, fatigue and muscle a... Read more
By nighttime the day of the shot I had developed a fever of 103, strong chills, fatigue and muscle ache. Fever and chills did not respond to fever reducing pills (Tylenol, acetaminophen or ibprophen). It lasted for 4 days straight before the fever broke. No noticable energy or strength for about 2 weeks.
49 2021-07-13 pain in extremity April 1st, I had leg pain and swelling. I went to the doctor - I had a blood clot in my leg. I had t... Read more
April 1st, I had leg pain and swelling. I went to the doctor - I had a blood clot in my leg. I had to go on blood thinners.
49 2021-07-14 slurring, facial paralysis, seizure like phenomena Pt. states after receiving 2nd dose of Phizer 04/25/2021, shortly after 04/28/2021 started to experi... Read more
Pt. states after receiving 2nd dose of Phizer 04/25/2021, shortly after 04/28/2021 started to experience stroke-like symptoms (facial sag, slurred speech, lost of limb control), ER visit seizure activity (tongue rolled back to throat), screaming. Was not seen by a Physician/RN. Still continuing to experience symptoms.
49 2021-07-14 numbness eceived 2nd dose at 1350, stated to staff at 1605 that she was "not feeling well". Pt now c/o numbne... Read more
eceived 2nd dose at 1350, stated to staff at 1605 that she was "not feeling well". Pt now c/o numbness of the lips, left arm, and left leg, feeling dizzy and tired. 1605 VS: 177/118, 104 HR, 96% O2 EMS alerted at 1616. 1620 VS: 168/104, 89 HR, 98% O2, POCT Glucose 82mg/dL. Pt sitting upright on a chair talking with staff, speech delayed. EMS arrived at 1622. Pt left with EMS via gurney at 1630 to ED for further assessment.
49 2021-07-15 seizure, feeling cold, tremor 12 hours later almost exactly, I started to feel hypothermic, my brain became foggy, I started shaki... Read more
12 hours later almost exactly, I started to feel hypothermic, my brain became foggy, I started shaking uncontrollably, could not think straight, stuttered, repeated saying how cold I was, temp 97 deg. Ended up falling asleep from exhaustion. Later was told it was likely seizures and should have sought treatment but couldn?t think straight to make that decision. Next day my body was extremely sour and tight from the convulsions.
49 2021-07-17 weakness having paranoid issues; she was not able to sleep and she was up all night; psychotic break; dizzy; ... Read more
having paranoid issues; she was not able to sleep and she was up all night; psychotic break; dizzy; and possibly a neurological one as well; swollen lymph node; the right side of her body and leg especially and her arm are less strong; COPD; she was feeling worse; Sjogrens symptom; Dry Mouth; had autoimmune reaction to it; chest pain; unable to walk due to joint pain; Lymph Node Inflammation; fatigue was getting worse; Doesnt feel well; This is a spontaneous report from a contactable consumer or other non hcp. A 49-year-old female patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number ER8727 Expiry date 31Jul2021) dose 1 on 23Mar2021 and dose 2 via an unspecified route of administration, administered in Arm Right on 13Apr2021(Age at vaccination was 49-years-old) (Lot number was ER8731 and Expiration Date: 31Jul2021) as a single dose for COVID-19 immunisation. Medical history included, pyrexia and non-tobacco user from an unknown date and unknown if ongoing she is a non-smoker, tuberculosis from an unknown date and unknown if ongoing in 1976 , malaria from 1993 to an unknown date. The patient's concomitant medications were not reported. On 15Apr2021 lymph node inflammation or neoplastic spots, a 1.5cm spot on the parotid gland, fatigue was getting worse, doesnt feel well and unable to walk due to joint pain. Caller states it started with Lymph Node inflammation on the left side and she tried to wait two weeks, using a hot compress and it didn't get better so she went to her doctor on 27APR2021 and had her look at it. she also feels fatigue, exhausted, and she doesn't feel well. Caller states that is not normal for her, she is an avid biker, and rides long distance, and now she is barely walking some days. On 24Apr2021 she was in the ER for her chest pains, they recommended an Echo, but her insurance denied it. On 27Apr2021 had autoimmune reaction to it and possibly a neurological one as well and sjogrens symptom also had dry mouth. She was having paranoid issues and hearing things and hearing biofeedback. Caller states she was in the psych ward until 02Jun2021, then she came home. Patient stated she had a neuro appointment when she was in the psych ward and they recommended a lumbar puncture, but she hasn't done it yet, but she may be doing it shortly. She was not able to sleep, and she was up all night and dizzy due to these all events patient was hospitalized from 26May2021 to 28May2021. On an unspecified date patient had swollen lymph node the right, side of her body and leg especially and her arm are less strong and she was feeling worse.Patient stated she ran a bunch of tests like Lyme Disease, Mono, Chest X-Ray which showed COPD. The patient underwent lab tests and procedures which included chest x-ray: no copd on had chest x-rays that show no COPD, chest x-ray: COPD on 21May2021 Chest X-Ray which showed COPD, computerised tomogram: unknown, computerised tomogram thorax: unknown, lyme disease: unknown, on 21May2021, magnetic resonance imaging head: unknown. she was taking Zyprexa. Patient states first it was 10mg, then they cut it in half to 5mg, and now she is taking 2.5mg. Caller states she got out exactly a month ago. Patient states it took a few days more while she was at home to fully recover. Patient states she thinks she was part of a study. Patient stated she does remember everything that she was thinking, sometimes that is how it works, and the paranoia and it was not a pretty time. Patient was also on Meloxicam 7.5mg due to event psych disorder. Outcome of the events psychotic break recovered on an unknown date and had autoimmune reaction to it, sjogrens symptom, lymph node inflammation, fatigue was getting worse , doesnt feel well, unable to walk due to joint pain, dry mouth and chest pain not recovered and rest all the events were unknown.
49 2021-07-17 numbness Throat became tight; Was still able to breath, but not comfortable; Left side of face became numb.; ... Read more
Throat became tight; Was still able to breath, but not comfortable; Left side of face became numb.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided, Unable to locate or read the details), via an unspecified route of administration, administered in right arm on 06Feb2021, at 11:15 as dose 1, single (age at vaccination: 49-year-old), for COVID-19 immunization. Medical history included thyroid cancer and breast cancer, both from unknown dates and unknown if ongoing and known allergy to penicillin. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took dextropropoxyphene (Darvocet), alprazolam (Xanax), acetaminophen;hydrocodone and venlafaxine and had known allergies to these medications. The patient stated that, on 06Feb2021, at 11:45 AM, her throat became tight, was still able to breath, but not comfortable and her left side of face became numb. She took Benadryl and that helped relieve her symptoms. Reportedly, no other vaccine was administered within four weeks. Covid was not diagnosed prior vaccination and post vaccination, she was not tested for Covid. The outcome of the events was recovered on unknown dates in 2021. No follow-up attempts are possible; information about lot/batch number cannot been obtained
49 2021-07-17 muscle spasms, weakness, discomfort, sciatica, difficulty speaking muscle aches and spasms; muscle aches and spasms/she was having muscle pain, just a burning pain; ha... Read more
muscle aches and spasms; muscle aches and spasms/she was having muscle pain, just a burning pain; having body aches; epigastric pain; not feeling well; Fatigued; diarrhea; nausea; vomiting; Anxiety; Weak; Voice is raspy from the nausea; muscles feel so tight; sciatica; feels really heavy; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0169; Expiration Date: 31Aug2021), in Arm Left on 23Jun2021 at 07:30 (at 49 years) at single dose for covid-19 immunisation. Medical history included ongoing depression (diagnosed about 3 months before maybe before that, she just hadn't taken anything. Patient reported that if she had to really say, she would say that she's had depression for 3 years since she lost her father; she had done counseling but this was first time she had asked for anything), anaphylactic reaction to meloxicam (MOBIC) in 2017. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) taken for depression from 21May2021 to Jun2021. On 24Jun2021 patient started having body aches, epigastric pain, not feeling well, fatigued, Diarrhea, nausea and vomiting.From Jun2021 Anxiety, Weak and voice was raspy from the nausea, muscles felt tight, sciatica and felt really heavy.On 26Jun2021, she had spasms and muscle aches . All events required Physician Office and were serious as medically significant. Clinical course was reported as follows: patient took her first of the vaccine on 23Jun2021.Ever since taking the vaccine, by 24Jun2021, she was starting to feel body aches, epigastric pain, and was not feeling well. She did a tele-visit on 25Jun2021 and on 26Jun2021 with her health care provider. On 26Jun2021, she was having spasms and her muscles were just hurting/ muscles were just on fire. Patient reported that she was completely out of commission on 26Jun2021. She reported that it was her and her 10 year old. She did the tele-visit because she couldn't get herself in the car and wasn't going to call an ambulance and scare her 10 year old.She has not felt fine since then. She has felt fatigued, weak, and achy, but she did not have a fever. Her physician called in Nexium and Pepcid AC over the counter for her epigastric and abdominal pain. Then she got steroids and Ibuprofen 800 for body aches.Patient reported that for the muscle spasms, she told her health care provider that she had a muscle relaxer. She reported that the muscle relaxer was old and it made her feel loopy. Patient reported that the muscle relaxer she took was Flexeril 5 mg (manufacturer Qualitest). Patient reported that she wanted a steroid because she was having muscle pain, just a burning pain. Patient reported that her health care provider did call in a Medrol Dosepak, too. She stated that she felt completely, if this is what Covid feels like, she's feeling it. She reported that this whole time she's gone without being sick at all, and she's been out working and everything. Patient reported that she was so terrified, she didn't want to get this again and she didn't want to get the second dose of the Covid-19 vaccine. Patient reported that she was still nauseous. Patient reported that the body aches and muscle spasms were not constant any more. On 28Jun2021, was the first day that she could get up and do research to see who she needed to call and research for these things. On 26Jun2021 she couldn't do anything and on 27Jun2021, she started to get up and kind of tried to do some stretches. She can't explain it, her muscles felt so tight and she's just trying to move around a little more. On 28Jun2021 she going to call her physician as she didn't feel well enough to drive there. Patient informed her physician that the muscle spasms felt like sciatica. It was a shooting pain on the left side where she got the Covid-19 vaccine injection. She was really scared. The muscle spasms have stayed the same; she felt really heavy, very heavy, and was making herself move. Patient reported that she felt more awake on 28Jun2021. Patient reported that the pain was so bad, and this was not her, not her at all, that she was hollering like she couldn't stand it. Patient reported that once she did the tele-visit and got ice on board and tried to numb the left side, it felt like she could tolerate more.She reported that she's sure that anxiousness got the best of her, but she has never experienced anything like that before. She had not done anything different other than she got the Covid-19 vaccine. Even her voice was raspy from the nausea. On 28Jun2021 she felt like she's more awake. The pain was not constant, it's intermittent. She felt like she's gotten past the worst of it, the worst part of it. She felt like that for sure, but the anxiety that it's given her to not know what the heck just happened to her, will this happen again, will it be long term - all these things that she's feared for a year were here. She inquired what she needed to do to make sure that she never has to get the Covid-19 vaccine injection again. Patient stated that she didn't want to feel this way again, she didn't want to feel worse after the second dose, and as a hospital employee they're going to make her get the second dose of the Covid-19 vaccine if she can't get any documentation. Patient reported that she thought that on 26Jun2021 when it all came to a head, it was bad. Caller reported that she was on the floor on 26Jun2021, was up more on 27Jun2021, and on 28Jun2021, she's up. She did have a moment where she felt that her side effects were medically significant, but she's past that. Patient wished she could have gotten to the emergency room on 27Jun2021, but with the tele-visit her health care provider only called in the prescriptions. Outcome of body aches, spasms was not recovered; Outcome of not feeling well, muscle aches/ burning pain, Voice is raspy from the nausea, , muscles feel so tight, sciatica and feels really heavy was unknown;Outcome of the other events was recovering.Events Body aches, Fatigued, Weak, Diarrhea, nausea and vomiting , abdominal pain upper, anxiety,asthenia,muscle spasm and voice is raspy from the nausea were reported as related to the vaccine.; Sender's Comments: As there is limited information in the case provided, the causal association between the events pain (body aches), abdominal pain, malaise, fatigue, diarrhoea, nausea, vomiting, anxiety, weakness, dysphonia, sciatica, discomfort, muscle spasm, myalgia and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-07-17 pain in extremity L Supraclavicular nodes x 2 (node #1 size of dime; node #2 size of penny); L arm soreness at injecti... Read more
L Supraclavicular nodes x 2 (node #1 size of dime; node #2 size of penny); L arm soreness at injection site.; swelling at injection site.; tenderness at injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in left arm on 27Mar2021(at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included DM2, HTN, Vitamin D deficiency, seasonal allergies, eczema, catfish/nickel allergies. Concomitant medications included lisinopril; hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASA), metformin hydrochloride (METFORMIN ER), cholecalciferol (VITAMIN D3) for unknown indication from unknown date. The patient had known allergies to catfish and nickel. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient experienced L supraclavicular nodes x 2 (node #1 size of dime; node #2 size of penny); left arm soreness, swelling, tenderness at injection site. It was reported that nodes were still present at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events lymph nodes enlarged, left arm pain, vaccination site swelling and vaccination site pain was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-07-17 speech disorder, feeling of body temperature change, migraine Hot and cold, sweating profusely; Hot and cold, sweating profusely; Raspiness, and coughing; Lack of... Read more
Hot and cold, sweating profusely; Hot and cold, sweating profusely; Raspiness, and coughing; Lack of Appetite; Chantix: Very emotional and snaps or cries in a moment.; Chantix: not sleeping well at all and only getting an hour at a time; She talks to herself a lot; would not breathe; mental problems; her balance is a hot mess; Migraine; Chantix: Ran out of medication; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient had also received varenicline tartrate (CHANTIX), oral from May2021 (Batch/Lot number was not reported) on an unspecified date, at starter pack; one tablet daily and oral from May2021 (Batch/Lot number was not reported) to an unspecified date, at ended up taking twice daily by mouth for smoking cessation therapy. Medical history included speech rehabilitation, physiotherapy, pneumonia, migraine suffered since she was 9 years old, neck injury from unknown date and unknown if ongoing, she broke her neck at 14 years. Concomitant medications included zolmitriptan (ZOLMITRIPTAN), butalbital, caffeine, paracetamol (FIORICET) taken for an unspecified indication. Patient had not any history other products. It was reported that, she was a long haul COVID patient. She was going through speech therapy and physical therapy all because of the COVID. She had really good results taking the Pfizer COVID vaccine, especially, the second dose. It helped her a lot. She had Chantix starter kit. She could hear she was having difficulty breathing. She had a migraine. She did not want her to relapse. Patient clarified information above. The COVID diagnosis occurred prior to receiving the Pfizer COVID Vaccine and before taking Chantix. The second shot was only a week and a half ago. She was slowly starting to feel like a human being again. She was still having the mental problems and her balance was a hot mess. She really wanted to get off from smoking. Chantix had just been in the last month. Her daughter was coming back from college and she has pneumonia and she cannot smoke around her. She had double pneumonia herself during COVID. The first time she got COVID virus was 26Dec2020 and they cleared her to go back to work. She made it back for 2 days and passed out and went to hospital. That was when she found out she had double pneumonia and may have caught COVID-19 again. She had side effects from first Pfizer COVID vaccine. But, she was still dealing with the post COVID. She did have to postpone first dose for a week or two because of times available. She started Chantix when she went to long term clinic after that. They were the ones that put her in physical therapy and speech therapy and helped her get on Chantix. She was still having the hot and cold and sweating profusely when she went in to get the vaccine, so it just continued. She really did not know a start date. It was getting better but has started again in the last 3 days. The raspiness and coughing had persisted through when she had COVID, but it is not near as bad. She had been a severe migraine sufferer since she was 9 years old. he had weird COVID migraines, but it was not the same. The migraine medications somewhat helped but not really. They really have gotten better. She just got one after the second dose. Before the last couple of days it had gotten better, but the last couple of days it had come back. Her brain just races and she forgot what she was saying. Her short term memory a joke. This happened before the vaccine and before the Chantix. It was still continuing. She broke her neck at 14 years old and got migraines from that. Lack of appetite was after the vaccine but more specifically after the Chantix. She just noticed it in the last week. It has persisted because she does not eat much when she has migraines. She was very emotional and snaps or cries in a moment. It could just be from the migraine or that she lost her healthcare. She is very overwhelmed right now and just noticed it in the past couple of days. She got mad at her cat and never does that. The angry part was within a week or two of starting Chantix. That was a side effect and they pointed it out to her so she is really working on that. She said it will get better since she was out of medication. Within first week of starting Chantix, she was not sleeping well. She had thrown away the Chantix container. She was ran out of Chantix from 30My2021.But again, she had the migraine so she cannot 100% say it was the Chantix. She talked to herself a lot. She honestly thought it may have started right before she got second dose of Pfizer COVID vaccine. She was trying to do too many things at one time and she cannot do it. A friend noticed she would not breathe and get herself worked up and told her to calm down and think of one thing at a time and it does seem to help a little bit. Even though she had double pneumonia, she was still craving smoking. That was why she started Chantix. Description of complaint: The migraine medications somewhat help but not really. They really have gotten better. She just got one after the second dose. Before the last couple of days it had gotten better, but the last couple of days it has come back. The medication they originally gave her is Zolmitriptan dose of 5mg, Manufacturer (Name). She took one and it did not work, so she did not take any more. The next medication was generic for Fiorcet, butalbacetamincass, 50-300-40. This one did work if it was a migraine triggered where she broke her neck, but not for the kind behind her eyes. The reporter seriousness for the adverse events was unspecified. The patient underwent lab tests and procedures which included SARS-COV-2 test which was positive on 26Dec2020. The outcome of event Chantix: Ran out of medication, hot and cold, sweating profusely, raspiness, coughing, migraine, lack of appetite, Chantix: not sleeping well at all and only getting an hour at a time was not recovered while outcome of Chantix: Very emotional and snaps or cries in a moment was recovering and the outcome for she talks to herself a lot, would not breathe, mental problems and her balance is a hot mess was unknown. Information about lot/batch no has been requested.
49 2021-07-18 migraine So far, four days late in starting cycle. This is highly unusual, in fact it has never happened. Def... Read more
So far, four days late in starting cycle. This is highly unusual, in fact it has never happened. Definitely a side effect of the vaccine. Migraine headache on day one after the vaccine also.
49 2021-07-19 feeling hot, burning sensation Two days after I got my first dose on 3/12/2021, I was eating dinner at about 6:30PM. My tongue felt... Read more
Two days after I got my first dose on 3/12/2021, I was eating dinner at about 6:30PM. My tongue felt swollen. When I ate, I had an intense burning sensation. The food wasn't spicy, but it was salty. I realized something was wrong, but I figured it was temporary; unfortunately, it has persisted and I still have it. I did research, and the description of burning mouth syndrome fits it. On 5/30/2021 at around 9:30AM, I was lying in bed and I felt really itchy, and it woke me up. I was also sweating and felt feverish. (This was over a month after my second vaccination.) I scratched my arm a little, but I didn't think much of it. When I got up at 11AM and went to the bathroom, I saw that both my arms were covered with rashes from the elbow down. As the day progressed, the itching was so intense, and I had a fever of 100. I took Benadryl and rubbed hydrocortisone cream all over my arms, but this helped very little. I then developed chicken pox-like blisters between my fingers, which popped on their own and oozed. The breakouts on my arms took different forms and included petichiae, blood blisters, and measles-like sores. The following day, I felt my ears get hot and itchy, and then the breakout spread all over my face; my cheeks were covered in welts. I finally got to see the doctor on 6/8/2021, but I got no diagnosis, since they didn't know if my symptoms were caused by long COVID or by the vaccine. They gave me hydroxizine, Chipro, and a shot of dexamethazone. I was advised to take ibuprofen for general pain relief and given betamethazone cream. None of the medications were at all effective. The symptoms then got much worse; the breakout spread all over my body and my skin felt like it was on fire! My skin was so hypersensitive that I couldn't bear to wear clothes or even pet my cat! I also had to keep my thermostat at 68 degrees. I currently have boils all over my face and scalp and boils. I am currently on doxycycline, famotidine, ceterizine, gentamicin cream, and ibuprofen.
49 2021-07-19 hot flush I started to feel nauseous, loss of my appetite, lightheaded, hot flashes and I loss my smell. The o... Read more
I started to feel nauseous, loss of my appetite, lightheaded, hot flashes and I loss my smell. The only thing I could do was drink liquids,
49 2021-07-19 tremor, numbness, weakness Weakness; Shaking all over; Very Tired; Fever; Terrible flu; Getting up to go to the bathroom was di... Read more
Weakness; Shaking all over; Very Tired; Fever; Terrible flu; Getting up to go to the bathroom was difficult.; Nausea; Left arm was numb; This is a spontaneous report from a non-contactable consumer, the patient. A 49-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via unspecified route of administration in the left arm on 25Mar2021 at 20:15 (at the age of 49 years) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via unspecified route of administration in the left arm on 03Mar2021 at 10:00 (at the age of 49 years), as a single dose for COVID-19 immunisation and aspirin on unknown date for unknown indication and experienced bruises. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021, the patient experienced her left arm was numb. On 26Mar2021, at 9:30 the patient experienced shaking all over, very tired, could not sit, and at afternoon fever above 102, left like she had a terrible flu, getting up to go to the bathroom was difficult and nausea. On 27March2021, the patient experienced weakness and tiredness persisted. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events and included treatment herself with ibuprofen. The clinical outcome of the events numbness upper arm, shaking, fever above 102, terrible flu, difficulty walking to bathroom, nausea, weakness and tiredness was recovered on 28March202. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
49 2021-07-20 numbness The right side of my face became numb from my forehead to chin; This is a spontaneous report from a ... Read more
The right side of my face became numb from my forehead to chin; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the right arm on 01Apr2021 at 13:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included insulin sensitivity. The patient had reported latex allergy. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), lorazepam (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN), all taken from unknown dates and for unspecified indications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 14:00, 30 minutes post vaccine, the patient experienced numbness on the right side of the face from forehead to chin. The numbness had lasted for several hours. The sensations were very similar to numbness and associated after effects experienced after a shot of novocaine during dental work. The event neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the event numbness on the right side of the face from forehead to chin was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-07-21 bell's palsy, facial paralysis Bells Palsy, facial paralysis on right side of face. Has not resolved at time of this report.
49 2021-07-21 fibromyalgia I started to feel very tired. I had pain in all my major joints. It felt like a fibromyalgia flare u... Read more
I started to feel very tired. I had pain in all my major joints. It felt like a fibromyalgia flare up. I had trouble sleeping and thinking. By the 4th week in April I could no longer walk I resigned from my job without notice on 4/30/2021. Prior to my resignation, my PA made notes when I spoke with her. I also spoke with my therapist and she advised me should would no longer make notes for me because I was too sick to work.
49 2021-07-21 pain in extremity Sore arm.; Tired; This is a spontaneous report from a non-contactable consumer, the patient. A 49-ye... Read more
Sore arm.; Tired; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received her unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unknown date the patient experienced sore arm and was tired. There was no information on whether the events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm and tired were unknown at the time of the report. Information about the lot number cannot be obtained. No further information is expected.
49 2021-07-21 tingling about 5 min after receiving vaccine pt complains of tingling on entire left side of face - no facial... Read more
about 5 min after receiving vaccine pt complains of tingling on entire left side of face - no facial dropping and lifting arms without difficulty and speech is not slurred - injection site unchanged - neuro check neg - BP 150/80 (systolic usually 140 per pt), Pulse Ox 99%, HR 71 - pt not eaten today (10 am) and had coffee stayed in chair with feet up (kept in recovery for 30 min) was able to stand withour difficulty, gait normal, told to seek medical attention if symptoms return
49 2021-07-21 tingling Felt extremely loopy; Tingling down both arms; This is a spontaneous report from a contactable consu... Read more
Felt extremely loopy; Tingling down both arms; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) in the right arm on 05Mar2021 at 16:30 and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) in the right arm on 26Mar2021 at 14:30 as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included metoprolol succinate (TOPROL), diltiazem hydrochloride (DILTIZEM), losartan (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR) and loratadine (CLARITIN). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have a history of allergies to medications, food or other products. On 05Mar2021 (as soon as injected), the patient felt extremely loopy and tingling down both arms, still had tingling in both arms from elbows to finger tips which was not constant but it was happened every day at different times since injection. The tingling after second dose was more noticeable and after 7 days patient still have it. Adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event extremely loopy was resolved after 2 hours on 05Mar2021. The clinical outcome of event tingling in both arms from elbows to finger tips was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-07-22 numbness, inability to speak On the 3rd day after the vaccine, I found I experienced numbness in legs, fingers and face. I found... Read more
On the 3rd day after the vaccine, I found I experienced numbness in legs, fingers and face. I found it hard to move muscles in my legs and face. My legs felt heay and unsteady when I tried to walk. It was hard to type and coordinate fingers to use my laptop. Also, I had to work harder to form words, especially consonant sounds. I did suffer the same reaction after my first COVID vaccine on June 26. However, I did not realize it was a vaccine side effect until it happened again after the second dose Before these side effects lasted for two days and then went away. I expect the same this time.
49 2021-07-22 numbness Patient reported facial numbness along right jawline as well as on the right side of the tongue
49 2021-07-22 numbness Felt disoriented 2.5 hrs after shot. 3 hours after shot felt complete body numbness. Could not fee... Read more
Felt disoriented 2.5 hrs after shot. 3 hours after shot felt complete body numbness. Could not feel hard pinches, slaps, etc. Felt completely drugged and unable to feel my body. Pressure in my head. Felt blood pumping in my head. Lasted about 48 hrs. Still do not have full feeling in my skin at three weeks later timeframe. Other symptoms more common were - pain at injection site, hard to lift arm because of pain night of 7/2. 4-5 days of nausea and loss of appetite. Sporadic joint pain in areas never had any joint paint before.
49 2021-07-22 muscle spasms Immediately after the second shot, injection site red and irritated. Within 24 hours the injection s... Read more
Immediately after the second shot, injection site red and irritated. Within 24 hours the injection site was swelling. The swelling has not gone down?3 months later I have a massive lump and chronic pain/spasms at site. I have tried anti inflammatory cream, pain pills, anti inflammatory pills, medical marijuana cream, CBD Oil, ice, heat?nothing has reduced the lump.
49 2021-07-22 pain in extremity On June 28th: Chest pain Left arm pain Jaw pain Was hospitalized and diagnosis was ultimately myoc... Read more
On June 28th: Chest pain Left arm pain Jaw pain Was hospitalized and diagnosis was ultimately myocarditis
49 2021-07-22 pain in extremity Very tired, heat beating fast,. Short of breath. Sore arm.
49 2021-07-25 pain in extremity First dosage: I started my period a week after the first vaccine,. This is abnormal because my mens... Read more
First dosage: I started my period a week after the first vaccine,. This is abnormal because my menstrual cycle ended on July 2, 2021, i have normal cycles, and I am no where near menopause. I also had a sore left arm and had a slight dizzy spell. Second dosage: Headaches, chills, body aches, nauseated, sore arm, and dizziness,
49 2021-07-25 paralysis, slurring, weakness weakness for minutes at a time, paralyzed for few minutes at a time, went to the the ER got a ct sca... Read more
weakness for minutes at a time, paralyzed for few minutes at a time, went to the the ER got a ct scan and it was clear. slurred speech
49 2021-07-27 weakness tired; achy; total exhaustion; muscle fatigue; joint pain; joint tenderness; overall weakness; This ... Read more
tired; achy; total exhaustion; muscle fatigue; joint pain; joint tenderness; overall weakness; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 09:15 as 2nd dose, single for covid-19 immunisation.Medical history included irritable bowel syndrome, spinal fusion surgery. Concomitant medication(s) included naproxen sodium (ALEVE).The patient had not known allergies.The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, the week following 2nd dose, tired &achy. Beginning 3 weeks after 2nd dose total exhaustion,muscle fatigue, joint pain, joint tenderness,and overall weakness which has persisted for more than 4 weeks. The events achy, total exhaustion on,muscle fatigue, joint pain, joint tenderness,overall weakness on 24Apr2021 12:00 with outcome of not recovered.Therapeutic measures were taken Iron & B12 supplements and Tylenol as a result of tired (fatigue), achy (pain), total exhaustion (fatigue), muscle fatigue (muscle fatigue), joint pain (arthralgia), joint tenderness (arthralgia), overall weakness (asthenia). Follow-up actions required. Further information requested.
49 2021-07-27 flushing felt flush; dizzy; nauseous; a pounding in her head; She wants to know if the vaccine would cause an... Read more
felt flush; dizzy; nauseous; a pounding in her head; She wants to know if the vaccine would cause any side effects with her glatopa medication.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, age at vaccination 49 years), dose 2 via an unspecified route of administration on 25May2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included glatiramer acetate (GLATOPA). The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single for COVID-19 immunization.The patient experienced felt flush, dizzy, nauseous, a pounding in her head, she wants to know if the vaccine would cause any side effects with her glatopa medication on 26May2021. Reported as, she got the second Pfizer COVID-19 Vaccine yesterday and when she took her glatopa today she felt flush, dizzy, nauseous, and a pounding in her head. She wants to know if the vaccine would cause any side effects with her glatopa medication. Outcome of the events were unknown. Information on the lot/batch number has been requested.
49 2021-07-27 migraine about 16 hours after shot, 102° fever, chills, headache and severe joint pain ( 8 on 1-10 scale) th... Read more
about 16 hours after shot, 102° fever, chills, headache and severe joint pain ( 8 on 1-10 scale) that lasted three days. It was painful to walk or lift my arms. Most severe pain in my hips. By day three, headache turned to migraine that lasted the rest of the week with nausea and vomiting from dizziness.
49 2021-07-27 migraine about 17 hours after shot, 102° - 103° fever, chills, headache and severe joint pain ( 8 on 1-10 s... Read more
about 17 hours after shot, 102° - 103° fever, chills, headache and severe joint pain ( 8 on 1-10 scale) that lasted three days. It was painful to walk or lift my arms. Most severe pain in my hips. By day three, headache turned to migraine that lasted the rest of the week with nausea and vomiting from dizziness. Also, new this time was 4 inch by 4 inch sized hematoma at injection site with swelling.
49 2021-07-27 muscle spasms Headache; Fatigue / Tiredness; nausea; feet cramp; no longer get periods since before 2021; The peri... Read more
Headache; Fatigue / Tiredness; nausea; feet cramp; no longer get periods since before 2021; The period lasted 09May2021 to 17May2021; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0173), via an unspecified route of administration in left arm on 29Apr2021 at 13:15 (age at vaccination 49-years-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history was none and not had any known allergies. Concomitant medication(s) included acetylsalicylic acid (ASPRIN) child asprin, cetirizine hydrochloride (ZYRTEC ALLERGY), caffeine, paracetamol (EXCEDRIN ASPIRIN FREE) and diphenhydramine hydrochloride, paracetamol (TYLENOL PM). Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09May2021, patient had a period lasted from 09May2021 to 17May2021. It was reported that the patient did not have a period since December 2020 and was always two days, and no longer get periods since before 2021 and have had twice blood flow, and on 10May2021, patient experienced headache, fatigue or tiredness, nausea, and feet cramp. Nausea and tiredness have kept patient away from being able to do my usual workout or other activities. There was no redness/swelling, muscle pain/pain, chills/fever. Patient had a doctor or other healthcare professional office/clinic visit because of event period lasted from 09May2021 to 17May2021. The doctor scheduled an ultrasound but not until 21Jun2021. Patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0187), via an unspecified route of administration, administered in left arm on 24May2021 at 13:15 as dose 2, single for COVID-19 immunization. Patient did not receive any treatment for the events headache, fatigue / tiredness, nausea and feet cramp and it was unknown if received treatment for event period lasted from 09May2021 to 17May2021. Since the vaccination, the patient had not been tested for Covid-19. The outcome of event period lasted from 09May2021 to 17May2021 was unknown, while all the other events were not recovered. Follow-up attempts completed. No further information expected.
49 2021-07-27 pain in extremity, cold sweat, feeling hot history included type 2 diabetes, high cholesterol, high blood pressure and neuropathy; all were fro... Read more
history included type 2 diabetes, high cholesterol, high blood pressure and neuropathy; all were from an unknown date and unknown if ongoing. Concomitant medications included metformin, ergocalciferol (VIT D), amlodipine and paliperidone (INVEGA [PALIPERIDONE]); all were taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced My body got really hot, cold sweat, Right leg is swollen and my feet swollen; I got pain in my leg and headache. Consumer stated as, got a question, Pfizer vaccine yesterday for the first time and my body got really hot last night and I had like cold sweat last night. Is that one of the side effects. My body got really hot you know I had to take cold shower to cool down and my right leg was swollen and my feet swollen. I got type 2 diabetes, I got neuropathy in my feet (history). I got pain in my leg and it was my first shot. The patient further stated, I want to ask was this make me sweat, body was hot it make me sweat. I just want to know if this is the side effect. The patient took a cholesterol pill and took a blood thinner too. Only got really really hot sweat last night again, the day I got really really hot again like come home took a cold shower and cool down with a fan. I had no fever only got really really hot. Therapeutic measures reported as, patient took two Tylenol for the headache, it was like a slight headache. No investigation assessment reported. Outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-07-27 pain in extremity, muscle spasms Severe stomach pain; Swollen glands; Vomiting; Severe headache; Severe fatigue; Knot in arm; Sore ar... Read more
Severe stomach pain; Swollen glands; Vomiting; Severe headache; Severe fatigue; Knot in arm; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Mar2021 at 08:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. It was unknown whether the patient had any allergies to medications, food, or other products. Concomitant medications included ziprasidone (MANUFACTURER UNKNOWN), clonazepam (MANUFACTURER UNKNOWN) and fluoxetine (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Mar2021 at 08:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021, right after second dose, the patient experienced sore arm and knot in arm (muscle spasm). On 28Mar2021 at 20:00, two days after second dose, the patient experienced severe fatigue and severe headache. On 02Apr2021, one week after second dose, the patient experienced vomiting, severe stomach pain, swollen glands and severe fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse events. The clinical outcome of the event sore arm, knot in arm (muscle spasm), severe fatigue, severe headache, vomiting, severe stomach pain and swollen glands was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-07-27 tremor, pain in extremity With the chills symptom I had severe tremors that lasted over 3 hours; With the chills symptom I had... Read more
With the chills symptom I had severe tremors that lasted over 3 hours; With the chills symptom I had severe tremors that lasted over 3 hours; Headache; Arm pain; Swelling; Muscle ache; Fatigue; Depressed appetite; Low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7533), via an unspecified route of administration on right arm on 21May2021 01:30 PM (age at vaccination: 49 years) as dose2, single for COVID-19 immunization at hospital. The patient medical history included Known allergies to Bandage adhesive. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient Concomitant medications within 2 weeks of vaccination included Multi-Vitamin. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6704), via an unspecified route of administration on Right arm on 30Apr2021 01:15 PM (at the age of 49 years) as dose 1, single for COVID-19 immunization. On 22May2021 12:15 AM, the patient experienced chills symptom she had severe tremors that lasted over 3 hours. she also had headache, arm pain and swelling, muscle ache, fatigue, and depressed appetite. In addition she had a low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received. Since the vaccination, the patient has not been tested for COVID-19. The lab tests included test: Low body temperature, result: 97.7-97 (Low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received) on 22May2021. It was reported that the awareness date 22May2021 is the same date that she began experiencing the symptoms. Due to the fatigue and feeling unwell she was not able to actually file the report until Sunday, 23May2021, but she did experienced the symptoms the previous day, Saturday, 22May2021. The patient did not receive any treatment for the events. The outcome of the events chills, tremors was recovered on 22May2021, while other events was recovering.
49 2021-07-28 numbness Itching all over my body within 5 minutes, redness and swelling at sight of injection, shortness of ... Read more
Itching all over my body within 5 minutes, redness and swelling at sight of injection, shortness of breath, tightness in chest. Pharmacist administered Zyrtec and symptoms subsided after 2 hours. Brain fog for 2 weeks, extreme fatigue. Still having itching episodes and numbness throughout body.
49 2021-07-29 feeling of insects crawling on skin Muscle fatigue; 4 days later in the evening felt nauseous; Woken up daily since feeling like ants cr... Read more
Muscle fatigue; 4 days later in the evening felt nauseous; Woken up daily since feeling like ants crawling under skin; Exhaustion (couldn't stay awake) after four hours; Heavy arm within one hour; Chills within 5 minutes; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 29Apr2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 12:45, within 5 minutes of vaccination, the patient experienced chills. On 29Apr2021 at 13:45, within one hour of vaccination, the patient experienced heavy arm. On 29Apr2021 at 16:45, four hours after vaccination, the patient experienced exhaustion (couldn't stay awake). Since 30Apr2021 at 04:00, the patient woke up daily at 04:00 feeling like ants crawling under skin which went away within 2 minutes. On 02May2021, 4 days after vaccination, in the evening, the patient felt nauseous and on 03May2021, on day 5 after vaccination, the patient experienced muscle fatigue. The clinical outcome of the events exhaustion, woken up daily since feeling like ants crawling under skin, heavy arm, chills, felt nauseous and muscle fatigue was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-07-29 numbness Exactly 20 minutes post-vaccination. Tongue felt odd like swelling; Exactly 20 minutes post-vaccinat... Read more
Exactly 20 minutes post-vaccination. Tongue felt odd like swelling; Exactly 20 minutes post-vaccination. Tongue felt odd like swelling, then left side of face to include ear and below left eye, upper and lower jaw affected (left side only). (Odd numbness)Complete left; (Odd numbness)Complete left side of face; Very little tingling in left side lower lip.; Still have some lingering weird feeling 3hr 45mins later.; This is a spontaneous report from a contactable nurse. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included zinc oxide (ZINC) from unknown date for unspecified indication and daily vitamin from unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 10:50, exactly 20 minutes post-vaccination, the patient experienced tongue felt odd like swelling, then left side of face to include ear and below left eye, upper and lower jaw affected left side only, odd numbness complete left side of face felt as if the patient had been injected by the dentist with lidocaine, very little tingling in left side lower lip which started to subside about 2 hours later, still have some lingering weird feeling 3hr 45 mins later. The events did not result in doctor or other healthcare professional office/clinic visit or emergency visit. No therapeutic measures were taken as a result of the reported events. On an unknown date, the patient underwent blood pressure test and the result was normal. On 07Apr2021, the patient underwent lab test and procedures which included BP, RR, HR and the results were found to be normal. The clinical outcome of the event very little tingling in left side lower lip was recovered on 07Apr2021 at 12:45. The clinical outcome of the events tongue felt odd like swelling, then left side of face to include ear and below left eye, upper and lower jaw affected (left side only), odd numbness complete left side of the face and some lingering weird feeling were unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
50 2021-01-02 pain in extremity Moderate to severe left arm pain. for 12 days now post first covid vaccine shot. Mild neck stiffnes... Read more
Moderate to severe left arm pain. for 12 days now post first covid vaccine shot. Mild neck stiffness also noted. The worse pain on left arm felt on first day, then slowly got better after. However still with Limited mobility (my left arm movement very guarded due to feeling of soreness on the affected arm), stiffness on left arm. Ice pack, advil and tylenol, and sometime with cyclobenzaprine, which I thought would help, but did not help.
50 2021-01-03 feeling cold Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to experience whole body chills, teeth chattering, and extreme fatigue. I took Ibuprofen and went to sleep. I experienced chills until approx 3 AM. My watch alerted my heart rate rose above 120 bpm three separate times during the night in the 1, 2 and 3:00 hours. Upon review of the summary it appears to have been sustained at just over 120 for that entire time. I awoke at noon, with a temp of approx 99.5 F, I felt extreme fatigue and a sense of cold but body was warm to touch and I was very sweaty this entire time. I slept most of the day and at 5 pm awoke with a temp of 102.4F. I contacted my physician who directed me to use tylenol and Benadryl. I took a dose at 5 pm, anther at 9 PM. Upon waking the next morning I was afebrile. At that time I felt slightly dizzy and lightheaded but also dehydrated. Forcing fluids relieved symptoms. I experienced a very mild headache and very mild queasiness as well.
50 2021-01-03 pain in extremity Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortne... Read more
Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortness of breath. Sore left arm all the way down arm. Rested and took ibuprofen. Today I returned to work still having headache
50 2021-01-03 pain in extremity After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was e... Read more
After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was extreme pain, I couldnt lay on it. Then about 3-4 days later, the color is blue and black. Then I started having cold symptoms. Like a head cold. On my left side, my arm and my leg is sore. In addition, my face broke out too. I did not go to the ER. I let Employee health examine my arm . No ER visit
50 2021-01-04 weakness allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her l... Read more
allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events "rash on her legs/ rash all over her" and "Fast heart rate" was not recovered, while other events were unknown.
50 2021-01-04 feeling hot 5 MINUTES AFTER INJECTION FELT WARM ALL OVER. HEART RATE 99 BP 180/101. SENT TO ER. GIVEN BENADRYL A... Read more
5 MINUTES AFTER INJECTION FELT WARM ALL OVER. HEART RATE 99 BP 180/101. SENT TO ER. GIVEN BENADRYL AND DISCHARGED TO HOME STABLE. EMPLOYEE REPORTS HER HR INCREASED THAT NIGHT AND NEXT DAY FOR A FEW MINUTES AND THEN COMPLETELY RESOLVED BY THE THIRD DAY.
50 2021-01-04 feeling of body temperature change, pain in extremity headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, som... Read more
headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, some chest pain, feel woosy, felt confussed right after vaccine,
50 2021-01-04 flushing After vaccine she felt flushed, heart rate 99 bp 181/105. Sent to ER. She reported chest tightness a... Read more
After vaccine she felt flushed, heart rate 99 bp 181/105. Sent to ER. She reported chest tightness and palpitations while in the ER. Given Benadryl and discharged stable. She reported that her heart rate went up again for a few minutes that night at home and next day and then she was fine.
50 2021-01-04 hot flush BP; 170/110 mild SOB palpitation (HR 80bpm) hot flashes mild sweating Took Claritin, increase flui... Read more
BP; 170/110 mild SOB palpitation (HR 80bpm) hot flashes mild sweating Took Claritin, increase fluid intake, and extra Valsartan x 1.
50 2021-01-04 numbness left sided numbness
50 2021-01-04 migraine Sometimes her headaches are migraines; Chills; Fever; Cough; Really lazy; Body aches; Headache; Naus... Read more
Sometimes her headaches are migraines; Chills; Fever; Cough; Really lazy; Body aches; Headache; Nausea; This is a spontaneous report from a contactable Registered nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: E10140), via an unspecified route of administration on 23Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included ongoing Diabetic for at least 7 years, ongoing hit in the head (She was a psych nurse and was hit in the head at work maybe a month to two months ago in 2020. She did have headaches from that incident). There were no concomitant medications. The patient experienced headache on 23Dec2020, fever on 24Dec2020 14:30, nausea on 23Dec2020, cough on 24Dec2020, really lazy on 24Dec2020, chills on 24Dec2020 14:30, body aches on 24Dec2020, sometimes her headaches were migraines on an unspecified date. Specifically, it was reported that when she first got the vaccine, she didn't have anything but a headache and a little bit of nausea. She had worked the night before and didn't sleep before the shot. So maybe that had a part in it. She was a diabetic. It was fine, and no big deal that night. Then, the next day on 24Dec2020 at 2:30 pm she woke up and she was freezing and couldn't get warm. She had chills and a fever of 102.1 on 24Dec2020. She took Tylenol, and it came down to 101 on an unspecified date in Dec2020. All weekend long, she has had a fever. It has been controlled by Tylenol. She had chills so bad she had to use her heated blanket. She has had a cough. She has been really lazy. She has had chills and body aches. She has had nausea here and there. She has had a headache. She received the vaccine on the 23Dec2020, which was Wednesday. She had to stay 15 minutes after. That is when she developed the headache and nausea. Sometimes her headaches were migraines. She developed the fever on 24Dec2020 14:30. Or noticed the fever when she woke up. Her fever was 101.2 this morning on 28Dec2020. Within the 15 minutes of getting the vaccine, she developed the nausea. It has gotten better. Her body aches are getting better. She still has chills when she is running a fever. She has gotten better overall. Thursday (24Dec2020), Friday (25Dec2020), and Saturday (26Dec2020) it was awful. Sunday (27Dec2020) the symptoms lightened up. Today (28Dec2020) she was better. She still had a headache and fever this morning, but nothing like she had been feeling. She felt like dying those days. She was a Psych nurse, and she got hit in the head. So she did get headaches from that incident. They are about the same as these headaches so she didn't know if it was related. It just went along with the flu like symptoms. But sometimes these headaches were migraines. Therapeutic measures were taken as a result of fever and chills. The outcome of the events headache, chills was not recovered. The outcome of the event really lazy was recovered on 27Dec2020. The outcome of the events fever, nausea, cough, body aches was recovering. The outcome of the event migraines was unknown.
50 2021-01-04 pain in extremity The patient reported ankle, leg and hip pain for which she is taking Motrin
50 2021-01-04 pain in extremity underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting he... Read more
underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting her; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH5730), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunisation. There were no medical history nor concomitant medications. The consumer received the vaccine on the 28Dec2020. She doesn't have a prescribing doctor. During the night after receiving the vaccine, her body was hurting her on 28Dec2020. She started to develop side effects 4-5 hours after receiving the vaccine. The side effects started during the evening the same day she got the shot. On 29Dec2020, the side effects were worse, she had a headache, and her arm hurt a little bit more. She then realized under her armpit was swollen a little bit / underneath her armpit was a little bit swelling on 30Dec2020. She talked to someone earlier about this and they told her to call her doctor. She had a lot of headaches. Everything is hurting her. The outcome of under her armpit was swollen a little bit was not recovered, of her arm hurt a little bit more was unknown. The outcome of the other events was recovering.
50 2021-01-05 weakness Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115... Read more
Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115; she was not feeling right, so she took the day off from work today; Lightheadedness; wobbly; she felt weak; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, expiration date: Apr2021), via an unspecified route of administration at right deltoid on 29Dec2020 17:45 at a single dose for Covid-19 immunization. Medical history included asthma from 2003 and ongoing, tachycardia and major surgery. Concomitant medication included maintenance inhaler (unspecified) for asthma. Patient was officially diagnosed with asthma in 2003. She said her asthma was controlled, and she takes a maintenance inhaler every day. She said she has been taking the same maintenance inhaler since she was first diagnosed with the asthma. She said she rarely uses a rescue inhaler. Reported she was prescribed the Metoprolol Tartrate 25mg for her tachycardia that she had after her major surgery, but she did not take the full 25mg dose during that time. She said she hasn't had taken the Metoprolol Tartrate 25mg in almost a year, clarifying it was last Jan2020 that she used the Metoprolol Tartrate. The patient previously received a flu shot in Oct2020, and felt rundown for a day afterwards, but that she always does after she receives a flu shot. She said she had no heart issues after receiving the flu shot in Oct2020. The patient who is a registered nurse reported she received the COVID-19 vaccine last night at work, on 29Dec2020, at 5:45PM, and had experienced some tachycardia after receiving the vaccine. Reported the COVID-19 Vaccine was offered through her employer. She said the COVID-19 vaccine was optional and offered to all employees if they work at the hospital. She experienced the tachycardia at 11:00 PM last night, 29Dec2020. She said her normal resting heart rate is between the high 60s to low 70s. She said her heart rate at 11:00PM last night was at around 100, clarifying she was not running a fever at that time. She stated after she received the COVID-19 vaccine, she was not feeling right, so she took the day off from work today, and slept in. She said when she woke up this morning (in Dec2020), she still didn't feel right, saying she felt weak and wobbly, and when she checked her pulse it was 115. She said she does have a past history of tachycardia. She said a year ago she had major surgery, and she had tachycardia after the major surgery. She said the tachycardia eventually went away, but she did have to see a cardiologist and take a beta blocker. She said she took a tiny dose of the beta blocker this morning, and called the cardiologist to let him know what was going on. She said she has not heard back from the cardiologist yet. She said the tachycardia went away once she took the beta blocker this morning. She said she took the beta blocker because her heart rate was going higher, and higher. She said she didn't want to end up like last year after her major surgery with a heart rate in the 170s. She said the tachycardia she was experiencing after receiving the COVID-19 Vaccine was not normal for her. She said once she got over the major surgery last year, her heart rate was fine. Reported her employer was making employees wait around for 15 minutes after the employees received the COVID-19 Vaccine to make sure no one had a major reaction to the COVID-19 Vaccine. She said after she received the COVID-19 Vaccine, she waited around longer than the 15 minutes. She said she felt weird after she received the COVID-19 Vaccine and thought maybe she was experiencing anxiety. She said she was lightheaded on 29Dec2020 after she received the COVID-19 Vaccine and completed a report right then on the website. She said the website is for reporting adverse events, and she was sent a website link to complete the adverse event reporting. She said she signed into the website link while she was still at the hospital. She said one of the website's first questions asked was how she was feeling. She said the question made her wonder if her lightheadedness was due to her heart rate being up because she becomes lightheaded when that happens. She clarified she reported only the lightheadedness on the website, and not the tachycardia. She said her lightheadedness got better and she was fine, and then at 11:00PM the tachycardia hit her like a switch. Reported this morning she felt fine, and then all of sudden she wasn't fine. Tachycardia Treatment: Reported she took a 8.5mg dose, or one quarter of a 25mg tablet (as provided by the reporter) of the beta blocker Metoprolol Tartrate 25mg tablet this morning and called her cardiologist to let him know. She said she split the Metoprolol Tartrate 25mg tablet this morning, and only took a quarter of the 25mg tablet (reported as a 8.5mg dose by the reporter). Reported she believes 100% that her tachycardia was caused by the COVID-19 Vaccine, saying she has been fine up until receiving the COVID-19 Vaccine. She said she got the COVID-19 Vaccine because she was afraid of getting the COVID-19 Virus with her asthma. She said she has no other preexisting conditions besides the asthma. Reported she is not going to get the second COVID-19 Vaccine dose. She said it was scary when her heart rate shot up out of nowhere. She said the COVID-19 Vaccine is the only thing different she has done. She said before the COVID-19 Vaccine, she was completely fine. Patient asked if the Pfizer DSU agent had heard of anyone else who has experienced tachycardia after receiving the COVID-19 Vaccine. The outcome of the event tachycardia was recovered in Dec2020, event lightheadedness was recovering and unknown for the other events. The reporter assessed the event 'tachycardia' as Serious (Medically Significant).; Sender's Comments: Based on the close temporal relationship, the association between the event tachycardia with BNT162b2 can not be fully excluded. The medical history of tachycardia and asthma medication may be contributory as well. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-01-05 facial pain . Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the... Read more
. Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the jaw line including the roof of my mouth. I took 3 Advil at the time and the woke again a couple hours later and took 2 more. In the morning it seemed fine. I have noticed a very slight change to my lower left eye - it seems lower.
50 2021-01-05 pain in extremity Had welt at injection site the size of golf ball with redness spreading from site out about the size... Read more
Had welt at injection site the size of golf ball with redness spreading from site out about the size of a baseball. Site itched, redness with heat coming out of site for several days. Arm soreness for 5-6 days afterwards. Injection give on 12/22/2020 and today 1/6/2021 there still is soreness at injection site and slight redness of the area.
50 2021-01-05 tingling, numbness Employee received the COVID vaccine on 12/21/2020. Employee reports her symptoms started on 12/30/20... Read more
Employee received the COVID vaccine on 12/21/2020. Employee reports her symptoms started on 12/30/2020. Employee states she cannot turn key in door or use right arm and hand normally. Employee reports parasthesias including slight numbness and tingling. Employee reports pain that is in the back of her shoulder that is rated as 2-3/10. Employee states all of her symptoms have been the same since 12/30 and have not worsened and no new symptoms had started.
50 2021-01-05 tingling swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ w... Read more
swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ went down chills/fatigues soreness to injection site( which was excepted)
50 2021-01-05 tingling Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened ... Read more
Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened with chewing and eating on left side on day one. Symptoms became worse during the day with electric like pain radiating to the maxilla, TMJ and temple. Symptoms persisted as episodic aching and electrical radicular pain 1/5 so I saw my dentist in the afternoon with a negative work up on exam and xray. Pain worsened and pattern expanded to include pain under tongue on left side. There are times there is no pain and then the pain will come on without known cause, but anytime with eating or chewing the pain starts and is exacerbated. Also impacted by hot items/drinks. I have tried ibuprofen and tylenol sinus medications without impact on episodic flares of pain.
50 2021-01-05 tingling Pfizer-BioNTech COVID-19 Vaccine EUA left arm and leg persistent paresthesias for two weeks
50 2021-01-05 tremor Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began... Read more
Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began after 10 hours - reduced pain after 24 hours, but still present Headache - began after 8 hours - still present Cough - began after 8 hours - still present Sore Throat - began after 8 hours - still present Shaking hands - began next morning - still present
50 2021-01-06 burning sensation, feeling hot warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u... Read more
warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u - stick neck, shoulder pain + heat, left cheek swollen been taking tylenol and benadryl saw PCP - received rx for prednisone
50 2021-01-06 depressed level of consciousness feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chill... Read more
feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chills while driving home; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the left arm, on 02Jan2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home on 02Jan2021 at 12:00. The patient did not receive any treatment for the events. The clinical outcome of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath cannot be excluded, considering the plausible temporal relationship. The underlying predisposing condition of penicillin allergy may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-01-06 numbness, feeling hot, tingling, pain in extremity, flushing The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pf... Read more
The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation. She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.
50 2021-01-06 migraine MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN A... Read more
MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN AND SWELLING TO INJECTION SITE BEGAN AT APPROXIMATELY 10:00 PM. TOOK TYLENOL 500MG AT 1:45pm THEN AGAIN AT 10:30 pm, also applied ice to injection site.
50 2021-01-06 pain in extremity Headache Left arm pain Narrative: 12/29 - onset of left arm pain. 12/30- onset of headache. 12/31 he... Read more
Headache Left arm pain Narrative: 12/29 - onset of left arm pain. 12/30- onset of headache. 12/31 headache still present but improve. Arm is mildly sore - much better
50 2021-01-06 tingling, numbness Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive ... Read more
Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive impaired, dizzy, disoriented
50 2021-01-06 tingling tinnitus, face tingling, lymph pain, general muscle pain
50 2021-01-07 weakness Difficulty breathing; Weakness; This is a spontaneous report from a contactable consumer (on behalf ... Read more
Difficulty breathing; Weakness; This is a spontaneous report from a contactable consumer (on behalf of his mother). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via an unspecified route of administration on 31Dec2020 between 09:00 and 10:00 at single dose on left arm for covid-19 immunisation (works in food staff at a hospital). Medical history and concomitant medications were none. Patient experienced: difficulty breathing and weakness on 01Jan2021. Events were ongoing and had gotten a little worse today (05Jan2021). The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was not resolved.
50 2021-01-07 cold sweat, seizure approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness o... Read more
approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness of breath and blocky red rash on neck and torso. immediately drove to urgent care, was not allowed in for treatment due to did not have phone on med to call for appointment. went home, took 50 mg benadryl and pepcid po. had tachypnea and continued blocky rash on neck and torso with chest tightness. took albuterol inhaler. approx 0200 had rigors/ seizure. with continued prior symptoms. took additional 50 mg benadryl and albuterol inhaler. temp 99.0. in am 1/6 called urgent care to make appointment thought neded steroid. they said to go to ED. was afraid to go to ED in fear would be intubated as had before for allergic reaction. took additonal 50 mg benadryl, pepcid and zyrtec along with a shot of epi pen. within minutes, all symptoms ressolved. will be calling place where I got vaccinated today to report. 1/8/21
50 2021-01-07 cold sweat 20 minutes after vaccine, cold chills sweat. 30 minutes after shortness of breath blochy rash neck/... Read more
20 minutes after vaccine, cold chills sweat. 30 minutes after shortness of breath blochy rash neck/ torso. went to urgent care, wouldnt let me enter becuase didnt have a phone on to call. Went home, took 50 mg benadryl pepcid PO. took albuterol inhaler due to tachypnea. tried to wait it out at home. apporox 0200, rigors/ seizure tachypnea continued with respirations ranging 32-38/min. took 600 mg ibuprofen and albuterol inhaler, additional 50 mg benadryl. continued blocky rash. next day, called urgent care asking for appointment, thought needed steroid, they instructed to go to ED to check for covid. explained to them not covid, but allergic reaction. afraid to go to ED in thinking may need to get intubated. approx 1030 am, had 2 addtional episodes of rigors/ seizure. temp never above 99.0 F. found epi pen in house and used it. no further rigors, no further tachypnea, rash disappeared.
50 2021-01-07 feeling cold 10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were ... Read more
10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were burning. I went to bed under 3 blankets and couldn't get warm. 5 hours later, the chills went away, but the pain persisted. 3 hours later, I took tylenol for the pain and felt much better 1 hour later.
50 2021-01-07 feeling hot, flushing sudden skin flushing from head to toe with feeling of extreme heat, feeling of doom and uneasiness t... Read more
sudden skin flushing from head to toe with feeling of extreme heat, feeling of doom and uneasiness that occurred within 3 minutes of injection, no tachycardia, hypertension noted, no wheezing, lungs clear, no SOB, treated with Benadryl and Pepcid with close observation for 30 minutes
50 2021-01-07 flushing Pt with history of allergic reactions, premedicated w/ Benadryl 50 mg po. 30 min after receiving the... Read more
Pt with history of allergic reactions, premedicated w/ Benadryl 50 mg po. 30 min after receiving the vaccination, she started to have difficulty breathing and chest tightness. No wheezing. Pt had neck and face flushing without hives. Pt tachycardic at 120 bpm. SOB and tachycardia lasted 1.5 hrs. Pt denies anxiety, dizziness or GI symptoms. Pt monitored and advised to avoid 2nd dose of mRNA vaccine; pt declined to see PCP
50 2021-01-07 numbness, facial pain, tingling sores and redness at the back of throat and tongue; sores and redness at the back of throat and tong... Read more
sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.
50 2021-01-07 numbness, tingling decreased sensation to light touch of right anterior distal thigh with intermittent shocklike pain s... Read more
decreased sensation to light touch of right anterior distal thigh with intermittent shocklike pain starting on 12/24/20 which has gradually improved with only rare episodes of numbness as of today 1/8/20. No weakness, back pain or injury.
50 2021-01-07 pain in extremity, weakness headache, sore throat, runny nose, arm pain that migrated to the axilla and down the side of the bod... Read more
headache, sore throat, runny nose, arm pain that migrated to the axilla and down the side of the body, joint pain ( hands, wrist, feet, hips, knees, spine, neck), insomnia, general malaise, fatigue, and lower grade fever. Most symptoms lasted about 7 -10 days. However, it is now day 20 after the initial vaccine and I still have joint pain that has not gone away. esp in hands, wrists, and feet. When I sleep I still wake up with all my joints hurting it gets better as I start moving but the wrist, hands, and feet pain has not gone away. This pain will wake me in the night when I change positions. I called my doctor today to inquire if it is a good idea if I should take the second dose because the first dose made me so dibiliated. Awaiting for a response. I am due to take the second vaccine on 2/9/21.
50 2021-01-07 tingling, weakness Immediately after client got her vaccine, she started feeling dizzy, and tingling "all over her body... Read more
Immediately after client got her vaccine, she started feeling dizzy, and tingling "all over her body." She was monitored and placed in a reclining position which did not help her. At 11:30 am client reported feeling weak. EMS was called and client was transported to hospital. She was given IV fluids and monitored and released 2-3 hours after the incident. She has not had any other problems since taking the vaccine.
50 2021-01-07 throat numbness Patient experienced swelling of the throat and numbness in the neck within 10-15 minutes of vaccine ... Read more
Patient experienced swelling of the throat and numbness in the neck within 10-15 minutes of vaccine administration while still under observation. Two oral Benadryl tablets were given (50mg total) and epipen was administered in the left thigh. 911 was immediately called and patient was taken away in ambulance
50 2021-01-08 weakness 01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and... Read more
01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red. 07:00am temp 99, took Tylenol 1000mg. 10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt. 2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat. 01/09/21 1:50pm continues with mild body aches and moderate headache.
50 2021-01-08 flushing Flushing, kept in Observation area for 30 minutes
50 2021-01-08 numbness, tingling Tingling and a feeling of numbness to R side of face
50 2021-01-08 migraine About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and B... Read more
About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and BP was 190/90 something. My resting HR is 56 and BP is usually around 120/80. Began to drop after about another 15 minutes. Followed by migraine for the rest of the day. Felt okay when I woke up, but had one episode during the day today in which my heart rate shot up again and was a little short of breath even though I was not exerting myself. Lasted about 10 minutes. Injection site hurts to the touch, but otherwise is painful. Throat hurts a little and a little congested, but probably unrelated.
50 2021-01-08 pain in extremity Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left a... Read more
Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left arm and severe headache 12/19/20
50 2021-01-08 pain in extremity Developed severe right leg pain, small rash on my right buttocks, tenderness at the LS joint, subseq... Read more
Developed severe right leg pain, small rash on my right buttocks, tenderness at the LS joint, subsequently diagnosed with shingles on 1/7/21
50 2021-01-08 tingling Fever Facial tingling, blue nailbeds Narrative: Facial tingling resolved. Still has low grade fever... Read more
Fever Facial tingling, blue nailbeds Narrative: Facial tingling resolved. Still has low grade fever, fatigue
50 2021-01-09 weakness Diarrhea started after having mild chills at around 1300hrs on 1/8/2021; then followed by tiredness ... Read more
Diarrhea started after having mild chills at around 1300hrs on 1/8/2021; then followed by tiredness and weakness. Got home at around 1545hrs and I continued to have diarrhea all night until Saturday -all day. Diarrhea settled at around 1800hrs.
50 2021-01-09 flushing Within 15 minutes of vaccine administration, I developed difficult swallowing, scratchy throat and s... Read more
Within 15 minutes of vaccine administration, I developed difficult swallowing, scratchy throat and severe flushing of face, neck and chest. This lasted about 1.5 hours. Symptoms resolved within 2 hours. Treated with oral Benadryl and Tylenol
50 2021-01-09 pain in extremity Low grade fever, large hard painful lump in right arm, achy joints
50 2021-01-09 tenderness After first shot notice a lump under my left armpit area. It didn?t quite go away and the after the ... Read more
After first shot notice a lump under my left armpit area. It didn?t quite go away and the after the second dose the lump got bigger and it?s a little tender this time. It?s been two days since the 2nd injection and doesn?t seem to be going down in size.
50 2021-01-10 breast pain Severe fatigue, joint pain and swelling, headache started on day after vaccine. Left arm pain at sit... Read more
Severe fatigue, joint pain and swelling, headache started on day after vaccine. Left arm pain at site of injection that progressed to L sided lymph node swelling on day after vaccine and has progressed to Left side lymph node swelling in L side of neck, axilla, Left side of breast, chest wall with pain still present and worsening 4 days after vaccine given (2nd dose)
50 2021-01-10 pain in extremity First night had fever (102.4), chills, body aches, fatigue and slight headache. My arm was sore but ... Read more
First night had fever (102.4), chills, body aches, fatigue and slight headache. My arm was sore but my armpit was so painful (felt like stabbing sensation). This lasted until around 2:00 pm Saturday. I felt ok except for being tired and armpit still hurting quite a bit. On Sunday, I was very tired and slept during the day and went to bed around 8:30 pm feeling like I had a slight sore throat, tired and mildly nauseous. My armpit still hurt quite a bit. I woke up Monday at 5:30 am and showered and was profusely sweating when I was getting ready for work - my temperature was 100.6 so I took 800 mg of Ibuprofen to help with the temp and the pain in my armpit. I did not go into work. I am still tired and my current temp is 100.1 (12:30pm) and sweaty. I do feel as though the severity of my armpit pain is lessening but it is still bothersome.
50 2021-01-11 weakness, pain in extremity Approximately 11 hours after the vaccination my arm became very sore, to the point that it was diffi... Read more
Approximately 11 hours after the vaccination my arm became very sore, to the point that it was difficult to lift it. I then developed body aches and chills. I did not develop a fever that I know of but the body aches and chills continues throughout the night. During the night a severe headache developed as well as generalized weakness. I was unable to sleep and had to miss work the next day. Because the weakness and body aches continue, I plan to miss a second day of work tomorrow. I treated the symptoms with Tylenol.
50 2021-01-11 weakness GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DU... Read more
GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DUE TO SEVERE SORENESS AND PAIN. PAIN PROGRESSIVELY LESSENED BUT THE SORENESS STILL VERY APPARENT. ON 1/5, SPOKE TO PRIMARY MD, XRAY ON LEFT SHOULDER DONE ON 1/6. ON 1/7, STIFFNESS WITH SEVERE PAIN UPON MOVEMENT NOTED ESP IN THE MORNING. ULTRASOUND WAS DONE ON 1/8, NOTED BICEPS TENOSYNOVITIS. ORTHOPEDIC SURGEON SEEN ON 1/11, W DX OF ADHESIVE CAPSULITIS, SUGGESTED FOR PT FOR NOW, AND OFF WORK, AND TO BE FOLLOWED UP ON 2/1 BY SAME ORTHO SURGEON. WILL NOT OFFER CORTISONE SHOT FOR NOW AS IT MAY COMPROMISED OR WEAKEN IMMUNE RESPONSE, IN WHICH MY SECOND COVID SHOT DUE ON THE 15TH OF JANUARY. FIRST APPT FOR PT ON 1/15
50 2021-01-11 bell's palsy, pain in extremity, facial paralysis Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 m... Read more
Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in right deltoid. Pain progressed over the next 5 days to arm and left eye. Dizziness, mouth drooping, and numbness developed. Went to ED and diagnosed with Bell's Palsy. Evaluated in ED for possible causes. Vital signs stable. CVA ruled out. Patient given ketorolac, droperidol, and IV fluids for her headache. Prescribed steroids and acyclovir for Bell's Palsy treatment. Prescriber instructed patient to return to ED immediately if symptoms worsen or additional symptoms develop. Follow up with patient on 1/5/21 with patient reporting some improvement in symptoms. Patient reported having a headache for 2 weeks straight prior to presenting to the ED on 1/3/21. Vaccine was administered on 12/28/21. Unsure if the Bell's Palsy was a result of the vaccine or some other inciting factor.
50 2021-01-11 burning sensation, tingling, numbness Within 24 hrs, developed headaches, burning sensation down spine and neck. fullness in head intensif... Read more
Within 24 hrs, developed headaches, burning sensation down spine and neck. fullness in head intensified next day. balance was off, numbness and tingling throughout body. Went to ER. Diagnosed Paresthesia
50 2021-01-11 burning sensation day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nod... Read more
day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nodes. At approximately 30 hours after injection - on face, neck, scalp - burning, blotchy, red rash (item 20 - recovered? yes to rash bcz I took Benadryl. lymph nodes still swollen)
50 2021-01-11 difficulty speaking INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PAR... Read more
INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PARNASAL INFLAMATION AND HOARSLY.
50 2021-01-11 feeling cold, migraine Chills, body aches, migraine, nausea. Improving
50 2021-01-11 feeling hot both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ... Read more
both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; felt tired most of the day; felt soreness at injection site; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), via an unspecified route of administration on left arm at 13:45 on 21Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension, central serous retinopathy, known allergies to penicillin and Nickel. Concomitant medication included losartan, hydrochlorothiazide, cetirizine hydrochloride (ZIRTEC) and multivitamin. The patient previously took clindamycin, Septra and Keflex and experienced drug allergy. Within 30 min on 21Dec2020 started at 02:30 PM, both ears felt hot, mildly itchy, slightly puffy, and bright red in color. The patient's tongue and mouth felt slightly tingly with a metallic taste. She felt tired most of the day. Next day felt soreness at injection site and joint pain. Soreness at injection site lasted several more days. Events resulted in Doctor or other healthcare professional office/clinic visit, events were reported as non-serious. The patient received Benadryl 50 mg & additional dose of Zyrtec as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date. No follow up attempts are possible. No further information is expected.
50 2021-01-11 feeling of body temperature change, pain in extremity not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she wa... Read more
not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she was hot and cold; dry throat; nausea; a little stomach upset; left arm was sore for several days too; Headache; muscle ache; joint pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable a 50-year-old female Registered Nurse reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 11:40 on Deltoid Left at single dose for covid-19 immunisation. Medical history included was none. There were no concomitant medications. The patient experienced headache, muscle ache, joint pain, left arm was sore for several days too on 17Dec2020; not feeling well, sore, runny nose, sore throat, swollen glands, sweats, chills, feeling like she was hot and cold, dry throat, nausea, a little stomach upset on an unknown date. The detail clinical course was provided as following: the nurse reported side effects and want to verify if side effects that "keep coming and going back every couple days" are "normal". Received first dose last 17Dec2020 and felt side effects on the evening. Returned on Monday last week, lasted until Friday, and back on 06Jan2021. The patient had developed a runny nose, sore throat, and feeling like she was hot and cold. She said she had sweats and chills, but no fever. She said she kept getting a warm sensation, and checked her temperature several times, but did not have a fever. She said she had a super dry throat, and her throat felt like a desert. She said she had swollen neck glands, clarifying the swollen neck glands were underneath her mandible. She said she had nausea, and a little stomach upset with no diarrhea. She said she was still not feeling well in her stomach. Reported last week she had 3 days with a nonstop headache, swollen glands, and a sore throat. She said the headache, swollen glands, and sore throat went away, but are back again, 06Jan2021. She said she was thinking what she was experiencing was more a side effect of the COVID-19 Vaccine than being ill because her symptoms went away and now were back. She said when a person was ill, the person got through the illness, and that was it, but her symptoms kept going away and coming back. Clarified the night of 17Dec2020, she had a headache and some muscle aches and joint pain, specifically in her neck. She said her left arm was sore for several days too. She said everything went away. She said she started feeling sick again last Tuesday, 29Dec2020, and felt ill through Friday, 01Jan2021. She said over the weekend she felt fine, and then on 06Jan2021, she was feeling ill with the same symptoms of a headache, sore throat, runny nose, and swollen glands. She said she thought it was odd that the symptoms came back again. She said maybe what she was experiencing were not side effects from the COVID-19 Vaccine, and she was ill. She said it was odd that she felt bad and then felt better, and then the symptoms come back again. Reported she can work through her symptoms, clarifying she had mild symptoms. The event outcome was unknown. All events were reported as non-serious. The events did not require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None. Treatment: Declined any Reported she was scheduled to get her second COVID-19 Vaccine dose on 07Jan2021. Information on the lot/ batch number has been requested.
50 2021-01-11 muscle spasms Fever, headache, nausea, muscle spasms, sensitive to noise and light, loss of appetite, very tired
50 2021-01-11 muscle spasms Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; Thi... Read more
Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; This is a spontaneous report from a contactable healthcare professional, a physician assistant. A 50-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included tachycardia, tension headache, and glucose tolerance impaired. Concomitant medications included rosuvastatin calcium (CRESTOR), gabapentin (MANUFACTURER UNKNOWN), and metoprolol (MANUFACTURER UNKNOWN). On 18Dec2020, the patient experienced hypokalemia, hypomagnesemia, hypocalcemia, tetany, muscle cramps, and hemoglobin dropped little bit. The clinical course was as follows: The patient received the vaccine and about 30 minutes later she started to "feel bad". She went to the urgent care and about an hour after they took her to the emergency room (also reported as hospital). She had a complete blood count, complete metabolic panel, and magnesium level done on the 18th, 21th, 23rd, 26th, 28th, 30th of Dec2020 and then again on 04Jan2021. On 18Dec2020, her initial lab test showed potassium: 2.6, hemoglobin: 10.2, magnesium: 1.2, and calcium: 5.7. The physician assistant reported that a potassium of 2.6 was critically low and a hemoglobin was 10.2 was about normal for the patient. She received oral medications of potassium 20 mEq twice a day and calcium and magnesium supplements once a day. On 04Jan2021, lab data showed: potassium: 4.2, magnesium: 2.1, calcium: 9.5 and hemoglobin: 14.5. Per the reporting physician assistant, the above levels went back to normal but stated she had to be supplemented to get back to that point. The clinical outcomes of the hypokalemia, hypomagnesemia, hypocalcemia, and hemoglobin dropped little bit were recovered on 04Jan2021; while that of the tetany and muscle cramps, were unknown. The physician assistant assessed the events as related to the suspect vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-01-11 muscle twitching One hour after receiving the COVID Pfizer vaccine, I experienced tightness in my throat. The tightn... Read more
One hour after receiving the COVID Pfizer vaccine, I experienced tightness in my throat. The tightness lasted about one hour, then I began with all over muscle shaking, which lasted about five hours. I had chills with the shaking, and sat on the sofa with a blanket and heater until the symptoms resided.
50 2021-01-11 tingling, flushing, tremor 30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tig... Read more
30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tightness and nose tingling, heart felt like it was racing. Blood pressure was 150/80 , Pulse 108, respirations 22
50 2021-01-11 tingling Patient reported tightness in her jaw muscles & tingling along her jawline within 10 minutes of rece... Read more
Patient reported tightness in her jaw muscles & tingling along her jawline within 10 minutes of receiving the COVID vaccine. Fifty mg of liquid diphenhydramine was administered & the patient was monitored for another 45 minutes. She reported her symptoms slowly improved over time. No throat or tongue swelling was reported at any time.
50 2021-01-11 tremor Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; inject... Read more
Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.
50 2021-01-12 feeling hot Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with resi... Read more
Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with residual left cheek swelling.
50 2021-01-12 pain in extremity Headache, Myalgia, PAIN IN THE LEFT AXILLA TO UPPER FOREARM; Narrative:
50 2021-01-12 tingling, pain in extremity Patient complaints of left hand tingling and upper arm pain and Right hand tingling and upper arm sh... Read more
Patient complaints of left hand tingling and upper arm pain and Right hand tingling and upper arm shoulders pain body aches and fever
50 2021-01-13 cold sweat, tremor Reported chills, shaking cold sweats throughout the whole night, fever of 102F, body aches and abdo... Read more
Reported chills, shaking cold sweats throughout the whole night, fever of 102F, body aches and abdominal pain.
50 2021-01-13 feeling hot Swollen lymph node warmth area fever pain
50 2021-01-13 numbness Patient complained of numbness r shoulder blade and up right neck. Denies other symptoms. Reports sa... Read more
Patient complained of numbness r shoulder blade and up right neck. Denies other symptoms. Reports same symptoms after first dose of Pfizer and lasted ~ 4 days after. Observed x 30 minutes. BP 128/80 HR 71 sat 100%
50 2021-01-13 migraine Chills; Muscle pain; Feel like real tired; Headache; headache, it's like migraine; This is a spontan... Read more
Chills; Muscle pain; Feel like real tired; Headache; headache, it's like migraine; This is a spontaneous report from a contactable consumer (patient). A 50-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient had the vaccine at her work and like in the night, in the morning, she started experiencing side effects. She was having like chills and muscle pain and she called her doctor and they told her that she had to report the side effects. She felt like real tired and she was having a headache. The patient took some Excedrin for headache, it's like migraine. She took two in the morning at 8:30. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
50 2021-01-13 muscle spasms "I have had a headache and been fatigued for about 4 days along with what feels like cramps in my ar... Read more
"I have had a headache and been fatigued for about 4 days along with what feels like cramps in my arms and legs. My arm is red and lumped up but not as bad as it was second day. Also having cold chills as well."
50 2021-01-13 pain in extremity, weakness Fatigue/headache/body malaise one hour after 2nd dose of COVID 19 vaccine. Now c/o (L) arm pain rad... Read more
Fatigue/headache/body malaise one hour after 2nd dose of COVID 19 vaccine. Now c/o (L) arm pain radiating to (L) elbow/(L) leg pain/dizziness/diaphoresis weakness to (L) lower extremity.
50 2021-01-13 pain in extremity It is causing a decrease in mobility and effecting her mobility; soreness in her arm; This is a spon... Read more
It is causing a decrease in mobility and effecting her mobility; soreness in her arm; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number: EL1284) via an unspecified route of administration on the left arm on 23Dec2020 17:20 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID vaccine and was still experiencing soreness in her arm for more than 2 weeks. She wanted to know if she should get the second dose. She also wanted to know if she does get the second dose can she ask for a different needle size and different injection site. She had soreness in her arm on 24Dec2020 and if it was related to the COVID Vaccine. The soreness in her arm is in the left arm where the site of injection was. She noticed when woke up like am in the morning. She had an X-Ray done yesterday 06Jan2021 and it did not show any type of dislocation or fracture. She stated she knew the soreness in the arm was most commonly seen 48 hours after getting the injection, the COVID shot, she knew this was a normal side effect. However, she was wondering why she is still experiencing this and it's going on 2.5 weeks now. She later clarified when speaking to previous agent they were providing the number to speak to someone more about the side effects and questions. She wanted to know why she was having it more than 2.5 weeks after getting it. She has read literature and she saw there where it can occur, but it indicated it would not be more than 72 hours. She was worried about this. It was causing a decrease in mobility and effecting her mobility. There was no history of all immunizations with the Pfizer Vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to the emergency room or physician office. Outcome of the event soreness in her arm was not recovered, while unknown for the other event.
50 2021-01-13 pain in extremity FATIGUE/HEADACHE/BODY MALAISE ONE HOUR AFTER 2ND DOSE OF COVID 19 VACCINE. NOW C/O L ARM PAIN RADIA... Read more
FATIGUE/HEADACHE/BODY MALAISE ONE HOUR AFTER 2ND DOSE OF COVID 19 VACCINE. NOW C/O L ARM PAIN RADIATING TO GIRON/R LEG PAIN/DIZZINESS/DIRPHORESIS WEAKNESS TO L LOWER EXTREMITY.
50 2021-01-14 weakness 1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tendernes... Read more
1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tenderness, body/muscle aches. 1/12/2021 @ 2300hrs - Body/muscle aches, chills. 1/13/2021 @ 0300hrs - Body/muscle aches, chills, fever 99.0, general malaise. 1/13/2021 @ 0600hrs - Body/muscle aches, chills, general malaise, no energy. Did not report to work. 1/13/2021 @ 1000hrs - Symptoms continued. Took Advil 600mg PO. Slept from 1030-1230hrs. 1/13/2021 @ 1230hrs - No energy, very tired, rested the entire day. Took Advil 600mg every 4 to 6 hours. 1/13 to 1/15/2021 - Left arm site tenderness with raised, hard area at injection site. Left armpit soft tissue swelling, possibly lymphadenopathy. 1/15/2021 - Reported symptoms to provider, awaiting appointment.
50 2021-01-14 facial paralysis, tingling, numbness HAD WITHIN A MINUTE TINGLING AND NUMBNESS OF THE LEFT SIDE OF THE FACE AND LEFT ARM. MORE PRONOUNCED... Read more
HAD WITHIN A MINUTE TINGLING AND NUMBNESS OF THE LEFT SIDE OF THE FACE AND LEFT ARM. MORE PRONOUNCED LEFT SIDE OF THE FACE, NUMBNESS LIKE I WAS GIVEN LOCAL TO THE LEFT SIDE OF MY FACE. COULD BARELY FEEL MY FACE ONLY LEFT SIDE. FELT I WAS DROOPING. TEETH WAS TINGLING. MY LEFT ARM GOT BETTER IN 2 HOURS. THERE WAS NO WEAKNESS. HOWEVER MY LEFT SIDE OF THE FACE WAS NUMB AND TINGLING LASTED APPROXIMATELY 2 DAYS. INTENSITY OF THE NUMBNESS GOT BETTER BY THE EVENING OF THE SHOT. I TOOK 325 MG OF ASPIRIN WITHIN 15 MIN OF THE EPISODE . MY PULSE, BP AND OTHER VITALS NORMAL. MAIN WAS MY LEFT SIDE OF THE FACE .
50 2021-01-14 feeling hot, hot flush Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to ... Read more
Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to floor with feet elevated. BP: 112/52 Reported Tingling lips- administered diphenhydramine 50mg at 12:36 1239: 122/78 1245: Feeling better, sat up in chair 12:56: Another wave of heat, nausea, dizziness- lied to floor. drank water. Denies breathing or troubles swallowing . Lip tingling has resolved
50 2021-01-14 flushing Patient reported feeling throat tight, tongue thick - lightheaded with fluctuating temperature : bp... Read more
Patient reported feeling throat tight, tongue thick - lightheaded with fluctuating temperature : bp 168-144/100-94 during episode with pulse ox 96%. patient was rosy and flush. Administered 1 epinephrine pen and 50 mg oral diphenhydramine . patient monitored from 3 pm until 530 pm and advised to see primary care provider
50 2021-01-14 pain in extremity, weakness feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; wea... Read more
feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; weak; her middle finger and index finger feel tight; her left shoulder feel really tight but has full sensation; unable to lift her left arm more than 30 degrees; pain in her arm; unable to sleep very well last night; This is a spontaneous report from a contactable nurse (patient) reported that a 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 08Jan2021(yesterday morning, Deltoid Left) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Historical Vaccine was included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. Patient received her second dose and within an hour she started feeling extremely tired, had a severe headache. When she woke up she noticed a large palpable knot on her left upper lateral deltoid in Jan2021. She stated that the injection went well and noticed no problems when she received the shot. At this time she was still very weak, her headache was still severe and she has noticed that her middle finger and index finger feel tight and her left shoulder feel really tight but had full sensation. She stated that she was unable to lift her left arm more than 30 degrees. She does not have a primary care physician at this time as she just relocated to her current residence. She stated that she was so uncomfortable due to the pain in her arm she was unable to sleep very well last night. She was going to seek medical attention at a local urgent care to be safe. The outcome of events, fatigue, knot on her left upper lateral deltoid, finger feel tight, shoulder feel really tight, unable to lift her left arm more than 30 degrees, pain in her arm, unable to sleep very well was unknown. The outcome of events of severe headache, weak was not recovered. Information about lot/batch number has been requested.; Reporter's Comments: her symptoms online per the Fact Sheet instructions. Potential
50 2021-01-14 pain in extremity Arm was very sore; Muscle aches; Scratchy throat; This is a spontaneous report from a contactable co... Read more
Arm was very sore; Muscle aches; Scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 9899), via an unspecified route of administration in right arm, on 21Dec2020 at 19:00, at a single dose, for COVID-19 immunization. The patient's medical history included attention deficit disorder (ADD), gastroesophageal reflux disease (GERD), migraines, allergies to latex and cinnamon (severe), gluten intolerance, and lactose intolerant. The patient's concomitant medications included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), candesartan, galcanezumab GNLM (EMGALITY), glucosamine, magnesium, melatonin, iron, escitalopram oxalate (LEXAPRO), omeprazole, ursodiol, colecalciferol (VIT D3), and buspirone hydrochloride (BUSPAR). The patient previously took acetylsalicylic acid (ASPIRIN), fentanyl, and codeine and experienced allergies to the medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 22Dec2020 at 9 AM, the patient's arm was very sore and had some muscle aches and scratchy throat. These lasted a little over 48 hours (2 days). The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 24Dec2020.
50 2021-01-14 tingling I woke about 3 am and had paresthesia of my fingers on my right hand. Thumb, index, middle and ring ... Read more
I woke about 3 am and had paresthesia of my fingers on my right hand. Thumb, index, middle and ring fingers. I Thought that I had slept in my hand wrong.; The discomfort at injection site woke me again last night and had the same feeling. It has remained after waking this morning; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 7530) solution for injection, via an unspecified route of administration on right arm on 08Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history was reported as none. The patient has no allergies to food, medications, or other products. The patient was not pregnant. Patient had the first dose of BNT162B2 on 18Dec2020 (lot number: EK 7530). Concomitant medications included multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]), ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES), and melatonin at 1.5 mg, daily. The patient reported that on 09Jan2021, she woke about 3 am and had paresthesia of her fingers on her right hand, thumb, index, middle and ring fingers. She thought that she had slept in her hand wrong. The discomfort at injection site woke her again last night (09Jan2021) and had the same feeling. It has remained after waking this morning. No treatment was given. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for Covid-19 since vaccination. Outcome of the events was not recovered. No follow-up activities are needed. No further information is expected.
50 2021-01-14 tingling We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on sta... Read more
We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.
50 2021-01-15 hot flush I had the first vaccine 12/22, no side effects at all. After this booster, I was fine until about 1... Read more
I had the first vaccine 12/22, no side effects at all. After this booster, I was fine until about 10 hours later-then had severe neck down my entire back pain, with restlessness, chills, and headache-this lasted about 24 hrs. The pain subsided and then I had liquid stooling for about 8 hrs with intermittent hot flashes. I am still having an "odd" feeling in my head, like foggy sensation, vertigo, and the sweating episodes as we speak.
50 2021-01-15 pain in extremity, tenderness Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, ... Read more
Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, malaise
50 2021-01-16 breast pain At 2AM, woke up with a fever of 103.6 and had a fever till Tuesday 1/12/21. Temp stayed between 102... Read more
At 2AM, woke up with a fever of 103.6 and had a fever till Tuesday 1/12/21. Temp stayed between 102-103 till 1/10/21 and on 1/11/21, temp stayed in the 100?s. I had redness from above the injection site down to my elbow x 4 days. The area was raised 1/2 inch. I had to take Benadryl to help with the reaction. On 1/10/21, my lymph node in my axilla on the same arm where the injection was administered started swelling and had redness and had redness and tenderness that extended to the left breast. Had a severe headache x 4 days with neck stiffness. The swelling in my axilla improved by 1/15/21. The redness and swelling in the arm resolved by 1/15/21. Headache still lingered till 1/16/21. Was out of work x 4 days
50 2021-01-17 weakness I got a fever 101 the day after shot , I had chills , my bones hurt the pain was very intense in rel... Read more
I got a fever 101 the day after shot , I had chills , my bones hurt the pain was very intense in relived by Motrin and Tylenol , intense pain at injection site my underarms hurt very badly / nausea/ intense fatigue all about 20 hours after injection hit me hard like a wall - this went on for 24 hrs then I felt better but felt very weak for 2 more day s- to day is 6 days after injection first day I feel normal again
50 2021-01-17 pain in extremity I have a fever, it maxed of this morning at 101.5; Nauseous; Body ache; Arm hurts; Chills; This is a... Read more
I have a fever, it maxed of this morning at 101.5; Nauseous; Body ache; Arm hurts; Chills; This is a spontaneous report from a contactable nurse (patient). This 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), via an unspecified route of administration, on 06Jan2021 at 5:15 at single dose for COVID-19 immunisation. Vaccine location was left shoulder. The patient was vaccinated at hospital, age at vaccination was 50-years-old. Medical history and concomitant medications were none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE an unknown date. Nurse stated she was just reporting some side effects from COVID Vaccine. She had second one last night at 5:15 and she is a nurse and she worked over night which she would never do that again. So, she has a fever, it maxed of this morning at 101.5 and chills, body ache, and she feels nauseous, and her arm hurts. Nausea was first at about 1:30 in this morning (07Jan2021) and then chills and then fever by about quarter to 6 this morning (07Jan2021), she started to check her temperature. Outcome was not recovered. No treatment was received for the events. She just didn't wanted to mask the fever. She wanted to see how it developed and her highest temperature was 101.5, then it came down a little bit, it's tolerable. About causality, nurse stated Yeah, most definitely.
50 2021-01-17 tingling, burning sensation Nausea, Headache, Joint swelling (couldnt make a fist), Pins and Needles on palms of hands, Pins and... Read more
Nausea, Headache, Joint swelling (couldnt make a fist), Pins and Needles on palms of hands, Pins and Needles bottom of feet,Burning feeling the bottom of feet, body aches, fatigue. No treatment. Event ended 30 hours after vaccine.
50 2021-01-17 tingling I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I fe... Read more
I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly.; little zingy feeling in my left pinky and ring finger; Pain injection site; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included was none. The patient's concomitant medications were not reported. The patient reported: " pain injection site" and "I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly. I had the vaccine in my left arm in my right hand I had a little tingly feeling and I was like well maybe because I am holding my pocket book on that side I shifted over, at work I am getting like just a little zingy feeling in my left pinky and ring finger". The patient outcome of the events was unknown.
50 2021-01-18 breast pain Pain in arm day of vaccination, 24 hours later felt sick. Had fever, body aches, chills, and dizzin... Read more
Pain in arm day of vaccination, 24 hours later felt sick. Had fever, body aches, chills, and dizziness. Next day felt ok but very dizzy. Kept feeling waves of dizziness every 20 minutes or so. Felt feverish that night, but just low grade fever. Also pain in the arm is now in my armpit area, down by my left breast.
50 2021-01-18 feeling cold 10 hours after the 2nd injection I developed severe chills for a couple of hours along with body a... Read more
10 hours after the 2nd injection I developed severe chills for a couple of hours along with body aches. The body aches lasted 24 hours.
50 2021-01-18 flushing Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and fe... Read more
Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and felt tight. The injection site looked OK. I was sweating and face was flushed. I was given Benadryl 50mg PO and lay down for an hour at work. I went home at 2:30p. The following day I went to work but at 12:00noon I was feverish (100.0F), dizzy, SOB, all-over sore muscles and my blood pressure was 200/100 taken twice by nurses at the facility. I was taken to the ER by car and had labs and work up in the ER. They were unable to determine if symptoms were vaccine related or not. I had taken first dose of hypothyroid medication on 1/14/21. They diagnosed hypertension and wrote me a script for Lisinopril 5mg PO daily. I continue to have high BP readings. My left arm at injection site is sore. The edema in my hand resolved the first day after the Benadryl dose.
50 2021-01-18 numbness, weakness Beginning on 12/26 (8 days after dose #1), patient began experiencing severe low back pain, B thigh ... Read more
Beginning on 12/26 (8 days after dose #1), patient began experiencing severe low back pain, B thigh pain, R knee pain, numbness radiating from her B labia radiating down the medial aspect of her lower extremities to her B halluxes, and possible B shoulder abductor weakness. Pt received dose #2 of the Pfizer vaccine on 6 January 2021 (Lot#EL0142). After dose #2, she noted fatigue and wheezing c/w prior asthma symptoms and took Prednisone 20mg x1. Her pain was much better the next day, but (cont'd)
50 2021-01-18 numbness Left side face and body numbness
50 2021-01-18 pain in extremity low grade fever (99.5), significant left arm pain radiating to neck, ear, hand, and fingers, arthral... Read more
low grade fever (99.5), significant left arm pain radiating to neck, ear, hand, and fingers, arthralgias, myalgias.
50 2021-01-18 pain in extremity Severe arm pain after shot. Woke me out of sleep night after shot. Unable to lift arm horizontal t... Read more
Severe arm pain after shot. Woke me out of sleep night after shot. Unable to lift arm horizontal to shoulder, knot size of walnut. Diarrhea x 24 hrs, headache, low grade temp, wheezing day 4, shortness of breath noted upon exertion day 3-7. Expiratory wheezing. Much better (able to walk without shortness of breath day 7). Laryngitis day 2-6. Went to ER. Received IVF for low potassium and dehydration due to diarrhea. T max 99.9.
50 2021-01-19 flushing Patient had same symptoms as she did after her first shot: tachycardia, flushed face, feeling ill. ... Read more
Patient had same symptoms as she did after her first shot: tachycardia, flushed face, feeling ill. She was observed for 30 minutes and felt better. Symptoms resolving.
50 2021-01-19 muscle spasms, weakness Chills fever muscle cramps weakness headache
50 2021-01-19 muscle spasms Swelling, deep muscle ache/spasm at injection site. Tylenol taken and ice pack at site
50 2021-01-20 cold sweat hours after vaccine I had an episode of sweating/clammy increase HR 128 lasting for a few minutes. ... Read more
hours after vaccine I had an episode of sweating/clammy increase HR 128 lasting for a few minutes. The next morning has slight fever 99 but with HA and body aches and continue with increase HR 110-138 at rest. 2-3 days after symptoms continued. On 4thday continue with HA, less intense but HR remain elevated 108-136 at rest and with light activity. HR continues to be elevated 1 week later 100-132 all other symptoms have resolved, no days of work missed
50 2021-01-20 feeling cold Chills and fever up to 102.5 reduced with advil. Fever started about 24 hours after vaccine was admi... Read more
Chills and fever up to 102.5 reduced with advil. Fever started about 24 hours after vaccine was administered. Gone around 48 hours after. Swelling and redness at injection site. No stealing.
50 2021-01-20 feeling cold Woke up the morning after vaccination with itching rash on neck, face, chest; chills but no fever; b... Read more
Woke up the morning after vaccination with itching rash on neck, face, chest; chills but no fever; body aches; rhinorrhea.
50 2021-01-20 numbness, cold extremities When at home unexpectedly developed severe coldness in right hand, especially fingers, followed by n... Read more
When at home unexpectedly developed severe coldness in right hand, especially fingers, followed by numbness. Since after few minutes and with rubbing it was not going away, proceeded with warming up hand under warm water and continued to rub it. Symptoms resolved 15-20 minutes later
50 2021-01-20 migraine inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); ... Read more
inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); Temp 102; body aches; chills; lymph node in right armpit swelling sz golf ball; vertigo all lasted 2.5 days; migraine pain >10 on pain scale; rash on hands and arms; nausea; blurred vision; Ongoing headache and body aches 5 days now; This is a spontaneous report from a contactable Nurse (patient). A 50-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2020 at 09:00 a.m. intramuscular on right arm at single dose for COVID-19 immunization. Relevant medical history included hypothyroidism, post-traumatic stress disorder, anxiety and allergy to tetracycline. Concomitant medications included escitalopram oxalate (LEXAPRO), celecoxib (CELEBREX), levothyroxine, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and paracetamol (TYLENOL). The patient received first dose of BNT162B2 on 18Dec2020 at 04:00p.m. intramuscular on right arm. On 07Jan2021 at 11:00 a.m. the patient experienced pyrexia with temperature of 102, body aches, chills, lymph node in right armpit swelling sz golf ball (as reported), nausea, migraine pain >10 on pain scale (as reported), rash on hands and arms, blurred vision and headache. On 08Jan2021 the patient underwent Nasal Swab SARS-CoV-2 test (Abbott) which resulted negative. No Treatment received for events. The patient recovered from vertigo on 09Jan2021. At the time of the reporting the patient had not yet recovered from headache and body aches, while was recovering from other reported events. Information about Lot/Batch number has been requested.
50 2021-01-20 pain in extremity Persistent Right arm tennis elbow; Increased pain on movement/Pain from back of elbow to top of fore... Read more
Persistent Right arm tennis elbow; Increased pain on movement/Pain from back of elbow to top of forearm; Increased pain on movement/Pain from back of elbow to top of forearm; This is a spontaneous report from a contactable nurse (patient self). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ELO140), via an unspecified route of administration on 19Dec2020 11:00 at single dose on right arm for COVID-19 immunisation. Medical history included hypothyroidism and known allergies: sulfa drugs and clarithromycin (MACROBID). Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), estradiol (ESTROGEN), testosterone and progesterone (PROGESTON [PROGESTERONE]). The patient experienced persistent right arm tennis elbow. Increased pain on movement. Pain from back of elbow to top of forearm on 21Dec2020 08:00 with outcome of not recovered. No treatment was received for the events. Patient received 2nd dose of bnt162b2 (lot: ELO140) on 09Jan2021 on left arm.
50 2021-01-20 tingling Moderate tingling and pin prink stabbing sensation in the soles of my feet and burning of my feet
50 2021-01-21 feeling cold Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigu... Read more
Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigue and nausea. About a day later she noted lightheadedness. About 1 days later she noticed soreness at the injection site and sensitivity to cold.
50 2021-01-21 pain in extremity 3x2, red, hard, swollen, painful, itchy patch in arm
50 2021-01-21 tingling, tremor, numbness, seizure Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, nu... Read more
Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, numbness and difficulty breathing -Medium
50 2021-01-22 weakness Body aches, headache, fever 101-102.2, weakness, shortness of air, severe chest pain
50 2021-01-22 muscle twitching 2-3 hrs after injection, L check muscle twitching that lasted until bedtime (3 hrs). Next morning, L... Read more
2-3 hrs after injection, L check muscle twitching that lasted until bedtime (3 hrs). Next morning, L check was not twitching but felt as though it might. This lasted all day. Within 2 days, there was a nerve sensation that radiated to L eye and L side of mouth. This sensation has persisted but improved now.
50 2021-01-22 pain in extremity Within 24 hours of dose, I had low grade fever, headache, and achiness despite being on ibuprofen ar... Read more
Within 24 hours of dose, I had low grade fever, headache, and achiness despite being on ibuprofen around the clock. Sore arm persisted for 5-6 days as well.
50 2021-01-23 weakness Nausea fatigue chills body aches low energy
50 2021-01-23 feeling cold Nausea, fever, chills, headache, severe muscle and joint aches, fatigue, blurry vision. Took Tyleno... Read more
Nausea, fever, chills, headache, severe muscle and joint aches, fatigue, blurry vision. Took Tylenol and Ibuprofen.
50 2021-01-24 difficulty speaking Mild wheezing and hoarse without sore throat on 12/21 Developed cough and wheezing, malaise, low gra... Read more
Mild wheezing and hoarse without sore throat on 12/21 Developed cough and wheezing, malaise, low grade temp, myalgia, arthralgia on 12/22 Tested positive for Covid on 12/23/20 at a drive through site. No other medical treatment was needed. I suspect I was infected but asymptomatic at the time I was vaccinated. I was told by the Health Department on the telephone to complete this form anyway.
50 2021-01-24 pain in extremity Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Sh... Read more
Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Short of breath and my heart was going faster than normal and short exertion. So I took an antihistamine - Allegra; tums; Tylenol; and took Prevacid. It didn't work. I was worried about my heart and that pressure on my throat. I went to my Dr. appt - she was able to get me in at short notice - and she examined me and did blood work and chest x-ray. Gave prednisone and albuterol . She said my lympyh nodes were swollen on my neck. Symptoms have resolved. And on second dose of vaccine I felt fine. But still have irregular heartbeat but I have a cardio appt coming up. I'm wearing heart monitor - Zeo - I mailed that on the 14 of January.
50 2021-01-24 tingling, feeling cold 1st 15 minutes, top lips getting warm, tingle legs on legs , coolness after 15 more minutes, patient... Read more
1st 15 minutes, top lips getting warm, tingle legs on legs , coolness after 15 more minutes, patient felt numbness of lips -- > sent to ER
50 2021-01-24 tingling, numbness, tremor 1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes... Read more
1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes of observation 2nd vaccine - within 2 minutes, similar symptoms started but gradually intensified. Additionally, had chest pressure, throat dryness, sensation of needing to breath faster (but not shortness of breath), presyncope, full body shaking (rigors) and hand numbness. Code medic called and wheeled down to ER. Symptoms (all of them) came in waves and intensified further in ER. Given IV solumedrol, benadryl and famotidine. Within a minute of IV meds, all symptoms resolved and felt fine for 15 minutes. The symptoms then returned in similar waves but with less intensity and further apart.
50 2021-01-25 weakness, feeling hot fatigue not resolved, muscle and joint pain severe all over body that has lessened but not resolved,... Read more
fatigue not resolved, muscle and joint pain severe all over body that has lessened but not resolved, intermittent nausea headache, feel feverish but no fever, weakness
50 2021-01-25 feeling of body temperature change headache; alternating feeling hot and cold; vomited; shaking chills; nausea; This is a spontaneous r... Read more
headache; alternating feeling hot and cold; vomited; shaking chills; nausea; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 06Jan2021 09:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 16Dec2020 (09:00 AM) for Covid-19 immunization. Medical history included hypothyroidism; no known allergies. Concomitant medications included levothyroxine, macrogol 3350 (MIRALAX), docusate sodium (COLACE), and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dihydrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, lycopene, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, xantofyl, zinc oxide (CENTRUM FOR WOMEN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that it was the second dose of her Pfizer COVID vaccine series; 12 hours afterwards she got shaking chills and nausea (06Jan2021) and this continued overnight, no fever. The next morning, she had the worst headache of her life, and nausea and alternating feeling hot and cold, no more shaking chills and no fever. The patient reported that it continued throughout 07Jan2021, and on 07Jan2021 she vomited once. Then 08Jan2021 in the morning, she still had the worst headache of her life, she took Ibuprofen to which the headache became much diminished. But headache continued with less intensity, so she was able to go to work throughout 08Jan2021. She continued with Ibuprofen and added Tylenol. Then at 3 am on 09Jan2021, she woke with the worst headache again so severe and took both Ibuprofen and Tylenol and it got better. By afternoon 09Jan2021, she was back to herself with no more headache and a normal appetite. She did take a sick day on 07Jan2021. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 post vaccination.
50 2021-01-25 pain in extremity 5-10 minutes after shot had a metallic taste in mouth, no adverse reactions. Next 2 days the injecti... Read more
5-10 minutes after shot had a metallic taste in mouth, no adverse reactions. Next 2 days the injection site became red, swollen (knot under skin) and grew in size to a silver dollar. My left arm was sore. Redness and swelling dissipated on 4th day and looked like a bruise. About 6pm on 4th day, I was itchy on my stomach. I didn't think twice as had a neoprene/spandex brace around stomach/back from exercise. When I finally took a shower at 8pm, I noticed my torso was completely red. I immediately took 2 Benadryl. Throughout the evening the rash/hives spread to my shoulders. Took 2 more Benadryl at 1am. By morning rash around torso was almost gone, but some spread slightly to wrists, shoulders, breasts and knees. Took 2 more Benadryl at 8 am. Applied Benadryl cream to few spots on body throughout today. Itching mostly gone but splotches on legs, neck and few on back. Will take more Benadryl about 6pm.
50 2021-01-25 pain in extremity Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills;... Read more
Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills; Mild dizziness; Intermittent heart racing; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 11Jan2021 (20:00) at single dose for Covid-19 immunization. The patient received the first dose of COVID 19 vaccine (BNT162B2, lot number: EJ1685), via an unspecified route of administration (left arm) on 21Dec2020 (03:30 PM) at single dose for Covid-19 immunization. The patient's medical history included idiopathic neuropathy to bilateral feet; no known allergies. Concomitant medication included tramadol. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, headache, body aches more in the legs, low grade fever, chills, mild dizziness, and intermittent heart racing on 12Jan2021 (08:00 AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
50 2021-01-25 tingling Approximately 17 minutes after receiving the vaccine in her left deltoid, patient complained of "tin... Read more
Approximately 17 minutes after receiving the vaccine in her left deltoid, patient complained of "tingling in arm". After waiting approximately 30 minutes after first report of tingling, patient stated tingling resolved with no other signs/symptoms.
50 2021-01-25 tingling About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including lef... Read more
About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including left eyelid. It improved over several hours. I had no swelling or drooping of my face, or trouble breathing.
50 2021-01-26 weakness Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea;... Read more
Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great. Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-01-26 cold sweat, feeling hot 1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycard... Read more
1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycardic with diffuse warmth and claminess. EMS was called after it didn't resolve after 20-30 minutes. Blood sugar 123. BP was elevated to high 160's over high 90s. EMS transported me to the ER. 1 liter of fluids given and BP was back to normal. Head CT scan was done and was normal. Dizziness persisted for about 6 hours and I was very tired for the rest of the day with achiness noted in the evening. I was fine by the next day. 2nd dose received on 1/21/21. I had only slight dizziness after that dose and was able to leave after 30 minutes observation time. Was very tired the weekend following vaccine and have had periods of dizziness/nausea since Sunday1/24/2021. I am still feeling dizzy and nauseated 1/27/21 and was encouraged to report possible side effect to the vaccine.
50 2021-01-26 flushing, pain in extremity, muscle spasms Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surfa... Read more
Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surface areas. About 10pm developed headache, facial flushing, painful eyes, fever 101.3, rigors, and muscle cramps in feet and legs.
50 2021-01-26 flushing Flushing, abdominal cramping, and throat fullness and pressure (globus sensation) IV push meds - S... Read more
Flushing, abdominal cramping, and throat fullness and pressure (globus sensation) IV push meds - Solu-Medrol, Benadryl and Famotidine Resolution of symptoms after medication administration. Diagnosis - Allergic reaction to COVID-19 vaccine
50 2021-01-26 numbness, pain in extremity After my first dose in the middle of the night I had an extreme arm pain from my left shoulder down ... Read more
After my first dose in the middle of the night I had an extreme arm pain from my left shoulder down to my finger tip that caused numbness of my fingers, I could not move my arm due to pain, I was not even able to roll over and sleep on it because the pain was so intense. The severe pain lasted about 2 days and my arm was sore for about a full week after.
50 2021-01-26 numbness Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingl... Read more
Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingling and numbness in my fingers I subsequently chewed three Benadryl tablets; symptoms began to resolve after about 1.5 hrs; fully resolved approximately 48 hours later
50 2021-01-26 migraine Migraine, 1/19 after 2nd dose, imitrex, lasted 1hour 1/2 Migraine, 1/26 after 2nd dose imitrex l... Read more
Migraine, 1/19 after 2nd dose, imitrex, lasted 1hour 1/2 Migraine, 1/26 after 2nd dose imitrex lasted 2hours both relieved with imitrex
50 2021-01-26 muscle spasms, weakness, tremor, feeling cold involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscl... Read more
involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-01-26 pain in extremity Right upper arm pain when I reach up, reach back, reach around and lift something heavy and with red... Read more
Right upper arm pain when I reach up, reach back, reach around and lift something heavy and with reduced range of motion and use in right arm. This started about 2-3 days after vaccine administration. I had no difficulty with right arm before vaccine.
50 2021-01-26 pain in extremity pain in arm difficult breathing cant breath through mouth spine hurts lower legs hurt fever headache... Read more
pain in arm difficult breathing cant breath through mouth spine hurts lower legs hurt fever headache nausea diarrhea
50 2021-01-26 tingling itchy, red splotches, hives, prickly sensation on skin on date of injection, then came back on Satur... Read more
itchy, red splotches, hives, prickly sensation on skin on date of injection, then came back on Saturday evening 1/23
50 2021-01-26 tremor sudden onset of nausea/dizziness, headache, severe chills and shaking, extreme body aches that laste... Read more
sudden onset of nausea/dizziness, headache, severe chills and shaking, extreme body aches that lasted approximately 10 hours, followed by extreme fatigue that lasted about 10 hours.
50 2021-01-27 numbness, tingling About 10 minutes after the injection she notice numbness and tingling in the palm of her hand that s... Read more
About 10 minutes after the injection she notice numbness and tingling in the palm of her hand that spread to her fingers. It has started to improve.
50 2021-01-27 numbness Facial numbness; This is a spontaneous report from a contactable other HCP. A 50-year-old female pat... Read more
Facial numbness; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) , via an unspecified route of administration in right upper arm on 12Jan2021 16:50 at a single dose for COVID-19 immunization. Vaccination was done in the clinic. There were no relevant medical history and concomitant medications. On 12Jan2021 17:15, the patient experienced facial numbness that started 25 minutes after she got the shot. The outcome of the event was recovered on 12Jan2021. The event was assessed s non-serious and the patient reported that the event was 100% related to the vaccine.
50 2021-01-27 muscle spasms 14 hours after the shot, I began having chills, a slight headache, muscle and joint pain, muscle cra... Read more
14 hours after the shot, I began having chills, a slight headache, muscle and joint pain, muscle cramps, and a slight upset stomach. It lasted throughout the night. In the morning (after symptoms between 11pm and 9am) I woke up with only the muscle and joint aches and a slight headache. The chills, muscle cramps and upset stomach were gone.
50 2021-01-27 pain in extremity Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine o... Read more
Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine observation. At 1035 customer called out to provider. Customer reports feeling acute nausea and she states she feels as if she is going to throw up. She appears slightly pale and significantly anxious. Customer is moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. Reports feeling sweaty, with waves of nausea and intermittent ULQ pain that she describes as sharp and bandlike across the diaphragm. She episodically calls out in pain and clutches her left chest below her ribs stating that it feels better when she puts pressure at the site. Customer admits to having significant anxiety and a history of panic attacks. HR 102, 02 99%. Lungs CTA. Customer accepts Benadryl 50mg PO @ 1043. Customer monitored at site. Over the course of the next 15 minutes, she reports feeling better and more relaxed. Customer reports full resolution of symptoms @ 1100. BP 108/82, P 101, O2 100% RA, RR 16. Customer is agreeable to extended monitoring after receiving Benadryl. She has been driven to the vaccination site by a family member and states she will not be alone at home. She is instructed to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer agrees with plan and denies further questions/concerns. Customer released from site at 1115, ambulating independently with steady gait, no obvious s/sx of distress.
50 2021-01-27 tingling, muscle spasms Joint pain, muscle pain, cramps in legs, tingling in hands and feet
50 2021-01-27 tremor Tremors, headache, nausea and dizziness
50 2021-01-27 unresponsive to stimuli Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache t... Read more
Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old.
50 2021-01-28 weakness feeling weak, dizzy, light headed and intense headache
50 2021-01-28 bell's palsy, face paralysis Stabbing pain in left ear, facial and eye weakness, new onset Bell's Palsy
50 2021-01-28 feeling cold 10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient star... Read more
10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient started to have hard time breathing and severely cold and BP was rising. 911 was called and patient was transported to hospital where she was admitted.
50 2021-01-28 migraine Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 ho... Read more
Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 hours. The migraine became debilitating on Sunday, January 3, 2021. I had vomiting, nausea and dizziness as well. I was unable to work on Monday, January 4, 2021 because I still had the migraine. I take Ubrelvy (prn) and it did not work. I attempted to return to work Tuesday afternoon as the migraine subsided, but it returned shortly after I made it to work. Our treatment nurse took my blood pressure, it was high. My blood sugar was high. I was dehydrated and the migraine was back. My nurse practitioner treated me with an IV of saline solution, pain relieving injection for the migraine and Zofran for the nausea.
50 2021-01-28 pain in extremity, muscle spasms, muscle twitching Leg pain; Back pain; Lips twitching; Achilles tendon pain in her left leg; back pain is almost like ... Read more
Leg pain; Back pain; Lips twitching; Achilles tendon pain in her left leg; back pain is almost like a spasm; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old female patient received BNT162B2 (lot number: EL1283), via an unspecified route of administration on 13Jan2021 12:04 at single dose for COVID prophylaxis. There were medical history and concomitant medications. It was reported that the patient experienced leg pain, back pain and lips twitching after injection which occurred two days ago on 13Jan2021. Stated that leg pain is like Achilles tendon pain in her left leg and back pain is almost like a spasm. She doesn't know if this is an expected side effect. Second dose is scheduled 09Feb2021. She wants to know if she should proceed with that. The outcome of the event "lips twitching" was unknown wile for the other events was recovering. The reporter assessed the events to be related to the suspect vaccine.
50 2021-01-28 tingling pt states that within 10 minutes after vax that she experienced cool tingling sensation down both le... Read more
pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat. Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot. They checked her blood pressure and it was high at that time 153/? Pt was from out of town so transported to Urgent Care via ambulance. Her blood pressure was 170/? at this time. They did an EKG which was normal. Pt was given Benadryl. Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg. Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong. Pt is waiting for her PCP to do tele visit for a FU.
50 2021-01-28 tremor This writer did not administer vaccine. Pt received vaccine at clinic and reported feeling shaky and... Read more
This writer did not administer vaccine. Pt received vaccine at clinic and reported feeling shaky and nausea . Denies sob chest pain headache feeling dizzy or lightheaded. No respiratory distress
50 2021-01-29 discomfort, pain in extremity Headache, Chills, Arm Pain/Discomfort, Fatigue
50 2021-01-29 hot flush Pt states that immediately after getting the vaccine she started having hot flashes. Pt was assisted... Read more
Pt states that immediately after getting the vaccine she started having hot flashes. Pt was assisted in walking to the cot. Pt was seated on the cot. Pt's vitals are stable. Pt states she has a history of anxiety. Pt states she started lexapro 2 months ago. Pt continued to have hot flashes for 30 mins. Crew was able to calm the pt. Pt refused transport to hospital.
50 2021-01-29 tingling, pain in extremity, muscle spasms, numbness Left leg parasthesias...pain, craming, heaviness and numbness. Improved over next 4 hours but mild ... Read more
Left leg parasthesias...pain, craming, heaviness and numbness. Improved over next 4 hours but mild tingling and numbness persists.
50 2021-01-29 tingling This is a female with a history of breast cancer on tamoxifen, hypertension, asthma who apparently r... Read more
This is a female with a history of breast cancer on tamoxifen, hypertension, asthma who apparently received her second dose of Covid Pfizer vaccine 10 to 15 minutes prior to presentation who presented in ED with complaints of shortness of breath and tingling sensation over her face and neck. Apparently had rash over the first dose and now presented with shortness of breath. She denies any fever chills. No chest pain. EPINEPHrine (EPIPEN) injection syringe 0.3 mg (0.3 mg intramuscular Given 1/26/21 1547) sodium chloride 0.9 % bolus 1,000 mL (1,000 mL intravenous New Bag 1/26/21 1555) dexAMETHasone (DECADRON) vial 6 mg (6 mg intravenous Given 1/26/21 1548) diphenhydrAMINE (BENADRYL) injection 25 mg (25 mg intravenous Given 1/26/21 1548) famotidine (PEPCID) injection 20 mg (20 mg intravenous Given 1/26/21 1548)
50 2021-01-30 weakness, numbness Dec 18, 2020, 1st dose effect was just like flu-like symptoms; I just felt heaviness in my left shou... Read more
Dec 18, 2020, 1st dose effect was just like flu-like symptoms; I just felt heaviness in my left shoulder and a bit sore; I even proceeded to work after the shot and never thought that the effect of the 2nd dose is severe; Jan 6-8, 2021, (Wed-Fri) @ 11:00am - took covid vaccine 2nd dose, proceeded to work. @4:00pm - sent me home; felt the adversed reactions: left side weakness and numbness from shoulder to foot, fatigue, chills, headache; took naproxen as needed, helped somehow to ease the pain; chills were on and off; Jan. 9, 2021 (Sat ) - continuous monitoring, took Naproxen; No headache; Still present is left side weakness and numbness; new symptoms - sore/pain in left shoulder, swollen in and around left shoulder, underarm, chest and back; lymph node is also swollen and tender; chills in the evening; Jan 10 - continuous monitoring, symptoms still present with sore and pain, , taking naproxen as needed somehow helped when the med kicked in but pain?s back after the effect; Jan 11, took pain med, managed to go to work from 12:00nn continuous until 4:00pm; the pain got worsen, due to pushing and pulling of beds and wheelchairs with patients; I emailed the Covid19 Employee Health, CC'd to my Manager, informed them about my current condition and made PCP appt on Jan 15. Covid19 Employee Health replied in email with instructions to keep the appointment for Jan 15 and take covid test.. then my Manager sent me home. Jan 12, as per advice, took my Covid19 swab test, turned out Negative ; Jan 15, more pain and couldnt hold anything or even raise my left arm; in and around my left shoulder, chest, underarm and back are still swollen and tender. I went to my scheduled PCP appointment, they prescribed me Prednisone and Hydrocodone(PRN) for pain for 5 days and also recommended me to see a Specialist and a special test such as CT or MRI. If the pain doesnt go away, a follow up appointment was also advice. They are also expecting to send them paperworks related to this work injury/illness; Jan 18, continuous monitoring, sore and swelling still exist; emailed me saying that they been notified for my injury/illness report; In the link of the email, it said that they will send me the documents packet to be filled out and my PCP is also expecting for the papers but havent recieved yet; Jan 21, Yesterday was my 5th day of taking prednisone.. As of today, my left shoulder and around chest, underarm and back are still sore and swollen. The prednisone helped during the day but pain still present at night and when in bed. Some nights I hardly sleep even putting some pillows around.. During the day, I am trying to slowly raise my left arm holding it with my right hand and do some stretchings too. Despite all of these efforts, the progress is slow and pain is still exist. I sent an update to my PCP and to my Manager; My PCP sent me a reply saying that she would order for an Imaging but still waiting for the documents packet to be filled out and signed but havent received it yet. Jan 22, took pain med this morning, pain is just #5, but still hardly raise much of my left arm, still sore and swollen around my shoulder; chills and headace no longer present; i just experienced them on and off in my first 4 days after the 2nd dose; slowly raising my left arm with the help of my right hand; doing stretching too Jan 25, 2021. Today, I'm still out from work. my swollen left shoulder is subsiding but 'Im worried about the sore and swelling around it like in my chest, underarm and back. I can now raise my left arm but there is still pain, still weak and no grip. Yesterday, I got my claim number thru Portal and gladly received the hardcopy of the said docs packet on the mail today. I have also a follow-up appointment with my PCP tomorrow, 10:45am and hopefully will get an imaging order.
50 2021-01-30 weakness HEADACHE!!!!!! Fever 101.5, Chills, Muscle pain, Weakness.
50 2021-01-30 cold sweat Woke up at 3 am with body aches-got up to take ibuprofen. When I was heading back to bed, my husband... Read more
Woke up at 3 am with body aches-got up to take ibuprofen. When I was heading back to bed, my husband heard a loud thud and found me laying on the floor beside the bed, passed out. He rushed over to me and called my name several times before I became conscious. He estimates it was a span of about 30 seconds. When I awoke, I immediately began to cold sweat and dry heave several times. Then I became cold and was shivering. My husband then transported me to the hospital emergency room. I received a cardiac test, which they said was good. I also received intravenous fluids and medication to treat pain and nausea. They drew labs which they said looked normal and did an X-ray my right shoulder because I struck my head and shoulder on a night stand when I passed out. They released me about an hour later after having me stand and walk to ensure my blood pressure did not drop, causing me to feel faint again. They sent me home with a prescription for Zofran to help with any further nausea, advised me to take ibuprofen for head and shoulder pain and body aches and advised rest. They also said to return if any other incidents occur and to follow up with my family doctor if symptoms persist.
50 2021-01-30 pain in extremity, tremor Extremely sore arm. Had injection at 10:55am on 1/30. 3:00am on 1/31 woke up with body violently sha... Read more
Extremely sore arm. Had injection at 10:55am on 1/30. 3:00am on 1/31 woke up with body violently shaking like I was cold, but I was not cold. I finally had to lay on my arms to hold them still. It lasted about 15mins.
50 2021-01-31 weakness, feeling cold I became increasingly sick within 24 hours after the shot. I was very tired, felt feverish, very col... Read more
I became increasingly sick within 24 hours after the shot. I was very tired, felt feverish, very cold, coughing, headache and diarrhea. 36 hours after the shot I began to notice a loss of taste and smell. 48 hours I was very weak and needed to sleep for the next 3 days. Overall loss of appetite, diarrhea and very bad cough continued for at least 1 week.
50 2021-01-31 weakness, feeling hot NOT FEELING MY NORMAL SELF, HEARTBURN, HOT IN ABDOMINAL, TEMP99, ANIXETY, DIZZY SPELLS, AWKWARD FEEL... Read more
NOT FEELING MY NORMAL SELF, HEARTBURN, HOT IN ABDOMINAL, TEMP99, ANIXETY, DIZZY SPELLS, AWKWARD FEELING IN MY HEAD, EXTREAMLY WEAK, THE 1ST DAY NOT SO BAD BUT DAY2-6 MUCH WORSE DAYS 7 &8 GETTING BETTER DAY 9 BACK TO NORMAL SELF.
50 2021-01-31 pain in extremity Arm soreness; Aches; Exhaustion; Diarrhea; This is a spontaneous report from a contactable consumer ... Read more
Arm soreness; Aches; Exhaustion; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 15Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included drug allergy to Quinolones, asthma and thyroid cancer from an unknown date and unknown if ongoing. Concomitant medication included omeprazole, levothyroxine sodium (SYNTHROID), topiramate (TOPAMAX) and sertraline hydrochloride (ZOLOFT). The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jan2021 02:00 PM, the patient experienced arm soreness, aches, exhaustion, diarrhea. No treatment was received for the events. The outcome of the events was recovering. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect.
50 2021-02-01 facial paralysis Went to ER with left facial paralysis. Diagnosed with Bell's palsy day 19 after initial dose of Pfiz... Read more
Went to ER with left facial paralysis. Diagnosed with Bell's palsy day 19 after initial dose of Pfizer vaccine (1/5/21 vaccine given). Not sure what the recommendation is as to whether I should still have the second dose. Doctors at the ER were not sure either.
50 2021-02-01 facial paralysis Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower... Read more
Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower left pain under ear, sudden onset; This is a spontaneous report from two contactable consumers. A 50-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, Post-traumatic stress disorder (PTSD), elevated pressure increased (BP), elevated cholesterol, spondylosis with radiculopathy. Known allergies: NSAID's and augmentin. Concomitant medications included hydrochlorothiazide, venlafaxine hydrochloride (EFFEXOR), hydroxyzine, atorvastatin and ascorbic acid;betacarotene;biotin; calcium; chloride; chromium; copper; folic acid; iodine; iron; magnesium; manganese; molybdenum; nickel; nicotinic acid; pantothenic acid; phosphorus; potassium; pyridoxine hydrochloride; riboflavin; selenium; silicon; thiamine; vanadium; vitamin B12 NOS; vitamin D NOS; vitamin E NOS; vitamin K NOS; xantofyl; zinc (CENTRUM SILVER WOMEN 50+). On 05Jan2021 at 13:00, patient experienced lower left pain under ear, sudden onset. Then, noticed symptoms of a stroke. Left sided face droop. Patient went to ER (emergency room). Patient was diagnosed with Bell's Palsy from Covid-19 injection (1st dose). Patient received treatments for the events included prednisone, acyclovir, ointment to protect eye and eye patch for covering of left eye. Lab test included Nasal Swab: negative on 07Jan2021. Outcome of the events was resolving. Information on Lot/Batch number has been requested.
50 2021-02-01 feeling hot metallic taste, hot trachea and esophagus, breathing difficulty, diarrhea, fatigue, extreme headache... Read more
metallic taste, hot trachea and esophagus, breathing difficulty, diarrhea, fatigue, extreme headache, sensitivity to light
50 2021-02-01 feeling jittery Dizziness, light headedness, jitters, tachycardia, high blood pressure; onset from right after injec... Read more
Dizziness, light headedness, jitters, tachycardia, high blood pressure; onset from right after injection; lasted 2 hours.
50 2021-02-01 flushing, feeling hot Immediate flushing of face. Itchy hands and arms. Ears and face red/hot. C/O hives on back. Hyperten... Read more
Immediate flushing of face. Itchy hands and arms. Ears and face red/hot. C/O hives on back. Hypertensive
50 2021-02-01 flushing, tremor Received 2 doses of Pfizer vaccine, 2 weeks after second dose, started to have tachycardia, flushing... Read more
Received 2 doses of Pfizer vaccine, 2 weeks after second dose, started to have tachycardia, flushing, tremors, ina bility to take deep breaths. New diagnosis of Grave's disease and enlarged lymph nodes in chest.
50 2021-02-01 numbness [ Pfizer Covid-19 vaccine ] treatment under Emergency Use Authorization(EUA): pt experience numbing ... Read more
[ Pfizer Covid-19 vaccine ] treatment under Emergency Use Authorization(EUA): pt experience numbing in hand of injection site on day of injection of dose one then experience numbing again three weeks later (before the second dose).
50 2021-02-01 muscle spasms R shoulder muscles frozen, unable to rotate R shoulder, to reach or to lift. All ribs and intercosta... Read more
R shoulder muscles frozen, unable to rotate R shoulder, to reach or to lift. All ribs and intercostals spasming, painful. Rigors and shaking chills without increased temp
50 2021-02-01 pain in extremity very tired; soreness in the arm; body aches; This is a spontaneous report from a contactable other h... Read more
very tired; soreness in the arm; body aches; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly on 18Jan2021 13:00, at right arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via a unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient experienced soreness in the arm, body aches, very tired on 19Jan2021 12:00AM. Therapeutic measures were taken as a result of all events includes Tylenol Every 6 Hours. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
50 2021-02-01 pain in extremity Soreness in L arm; soreness in L axilla; Soreness in LU torso; Numbness/tingling in lips and tongue;... Read more
Soreness in L arm; soreness in L axilla; Soreness in LU torso; Numbness/tingling in lips and tongue; Metal taste; Numbness/tingling in lips and tongue; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia, chicken allergy. Patient was not pregnant at the time of vaccination. Patient previously took BACTRIM and experienced allergy. There were no other medications received within 2 weeks of vaccination. The patient soreness in L arm, L trap, L axilla, LU torso, numbness/tingling in lips and tongue and metal taste on 29Dec2020 09:00. Outcome of the events was recovered. Treatment was not received for the events. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 05Oct2020 and negative on 08Nov2020. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. The events were considered non-serious.
50 2021-02-02 tingling Tingling, Numbness Narrative: 5 min after vaccine administered IM to L deltoid she developed L arm ... Read more
Tingling, Numbness Narrative: 5 min after vaccine administered IM to L deltoid she developed L arm and L trunk tingling. Tingling these locations resolved. Developed mild perioral tingling. At 1149 mild numbness tongue and lips. At 1155 resolving perioral tingling and numbness.
50 2021-02-03 feeling hot Patient here for her 2nd Pfizer vaccine. Immediately after she got it, she began to have moderate/... Read more
Patient here for her 2nd Pfizer vaccine. Immediately after she got it, she began to have moderate/severe nausea. She is also having light headedness. Her vitals are 136/90, P-98, O2- 98 @ 1447. She denies history of vaccine allergic reactions. Her only reaction from 1st injection was a sore arm. Her baseline vitals are 121/?, P-60-70. @1452 vitals are 134/88, P-122, o2-99. No meds have been given. Patient given ice pack for neck and reclined in reclining chair. Dr. consulted. Vitals @ 1510 130/70, P-106, 24 resp. Dr. advised further monitoring for the mean time. TC to patient's manager, that patient is having reaction to vaccine and is being monitored and will be delayed in returning to dept. Manager verbalized understanding and appreciation. (Created on 2/04/2021 and 3:42pm) Vitals @ 1553 147/80, P-98. Patient reported that nausea is still the same but that her throat started feeling funny. 50mg Benadryl IM given in Right Deltoid by RN @1600. Dr. informed. Director and AD also informed of situation. Patient's manager called by RN to give update on patient and to request that someone in dept bring patient's handbag. (Created on 2/04/2021 and 4:21pm) Vitals @ 1620 139/86, P-86, O2-97, Resp- 28. Patient reports that strange feeling in throat is improving. Nausea & light headedness is the same. She said that she had been feeling hot earlier but not anymore. Updated Dr. on patient's status. Asked Dr. if she may be released to go home with her aunt who is picking her up at 5pm if patient is stable and her vitals are stable. Dr. stated that patient may be released with a Benadryl tablet to go. (Created on 2/04/2021 and 4:43pm) Vitals @ 1720 163/96, P-114, O2-100 Called IMT to PFW 4. Patient initially refused to be taken to ER. Noticed that patient was having labored breathing. Vitals @ 1739 162/91, P-124. After IMT team spoke with patient about vitals, patient decided to go to ER. Patient was taken in wheelchair by IMT team@ 1745.
50 2021-02-03 migraine Swelling of forearm; trouble with movement in right hand; heaviness in same arm; Hives; itching; hea... Read more
Swelling of forearm; trouble with movement in right hand; heaviness in same arm; Hives; itching; headache that has turned into migraine.; headache that has turned into migraine.; This is a spontaneous report from a contactable other Healthcare Professional. A 50-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), intramuscular at right arm on 14Jan2021 13:00 at single dose for covid-19 immunization. Medical history included allergies to penicillin and sulfa. Concomitant medication included bupropion, propranolol, topiramate, sertraline, montelukast, alprazolam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first dose of BNT162B2 (lot number: EL1284) on 27Dec2020 02:30 PM intramuscularly at right arm for covid-19 immunization. The patient experienced swelling of forearm, trouble with movement in right hand and heaviness in same arm. Hives, itching, headache that had turned into migraine. The symptoms started the day after the injection (15Jan2021). No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
50 2021-02-03 pain in extremity arm was sore; arm was sore, muscular; This is a spontaneous report from a contactable consumer (pati... Read more
arm was sore; arm was sore, muscular; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, COVAX US Support. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose (lot number: EH9899) via an unspecified route of administration (left arm, also reported as "in left shoulder") on 29Dec2020 around 09:30am at single dose; and the second dose (lot number: EL1283) intramuscular (left arm, also reported as "in left shoulder") on 19Jan2021 around 10:30 at single dose for Covid-19 immunization (also reported as "prevent Covid"). There were no medical history and concomitant medications. The patient confirmed that she received first dose on 29Dec2020, and she received the second dose on 19Jan2021. There were no additional vaccines administered on same date of the Pfizer vaccine. The patient reported that she took the second dose of the Covid vaccine on 19Jan2021 and stated that her husband was diagnosed being positive for Covid. The patient asked if she was exposed to Covid if she will still be asymptomatic. The patient further stated that she feels great and has no side effects from the vaccine. She later clarified that her arm was sore on an unspecified date, and it occurred with both doses. She added that it was just muscular and starting to get better. The patient further reported that yesterday her husband was diagnosed with a positive test for Covid. She added that she works with Hospice patients. She confirmed that she is not a hcp. She just needs to know if it is safe for her to start seeing patients if she has zero symptoms, and if she needs a negative Covid test. There was no treatment received for the adverse event. The outcome of events was recovering.
50 2021-02-03 pain in extremity her right hand is slightly swollen; Where she got the shot is a little red, warm, and swollen; Where... Read more
her right hand is slightly swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; a little sore; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: 3248), via an unspecified route of administration in the right arm on 18Jan2021 at 08:40 A.M. (at the age of 50 -years-old) as a single dose, dose 2 for COVID-19 vaccination. Medical history was unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), single dose, dose 1 in the left arm on 28Dec2020 and a flu vaccine on 29Aug2020. There were no concomitant medications. On 19Jan2021, the patient's right hand is slightly swollen. It was still mobile. She can move all digits. It was puffy and a little sore and where she got the shot was a little red, warm, and swollen. There were no relevant tests done. The patient had no emergency room or physician office visits. The clinical outcome of right hand is slightly swollen, puffy and a little sore and where she got the shot was a little red, warm, and swollen was not recovered.
50 2021-02-03 pain in extremity Body aches; Chills; Headache; Arm was really, really sore - the whole arm; This is a spontaneous rep... Read more
Body aches; Chills; Headache; Arm was really, really sore - the whole arm; This is a spontaneous report from a contactable consumer (patient who is a mental health therapist). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 15Jan2021 at 16:00 (4 PM), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. No other vaccines were given the same day or 4 weeks prior. No problem with vaccines in past that she can recall from childhood. The patient received the vaccine last Friday (15Jan2021) and side effects started early evening Saturday (16Jan2021) or late afternoon. The patient had body aches, a few chills, headache, and her arm was really, really sore - the whole arm. At the time of reporting, all are way better. The patient was recovering from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
50 2021-02-04 burning sensation skin on her face feels burnt and sore to touch; skin on her face feels burnt and sore to touch; Bad ... Read more
skin on her face feels burnt and sore to touch; skin on her face feels burnt and sore to touch; Bad headache; medical history: lupus anticoagulant positive; medical history: lupus anticoagulant positive; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via intramuscular route of administration on 19Jan2021 at 12:00 at a single dose in the arm left for COVID-19 immunization. The patient's medical history included high blood pressure, hypothyroidism, depression, lupus anticoagulant positive, and anemia. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), verapamil, apixaban (ELIQUIS), montelukast sodium (SINGULAIR), levothyroxine sodium (SYNTHROID) , ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC), hydrocodone bitartrate, paracetamol (NORCO). The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and acetylsalicylic acid (ASPIRIN) and experienced allergies. The patient also previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 ) on 29Dec2020 at 08:00 pm, via intramuscular route in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Jan2021 at 19:00, the patient stated that her skin on her face feels burnt and sore to touch without any redness or signs of injury and had a bad headache. The patient did not receive any treatment for the reported events skin on her face feels burnt and sore to touch and bad headache. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient has not recovered from the events.
50 2021-02-04 flushing Left arm injection site, itcy and tingling on down both arms, flushed throughout body, 140/80 BP, HR... Read more
Left arm injection site, itcy and tingling on down both arms, flushed throughout body, 140/80 BP, HR 71 and RR 18. Headache later that night, with chills and fever for 2 days. Took Tylenol.
50 2021-02-04 migraine Within 4-5 hours, muscle soreness on shoulder at injection site. Within 12-13 hours, migraine, feve... Read more
Within 4-5 hours, muscle soreness on shoulder at injection site. Within 12-13 hours, migraine, fever, chills, body aches, nausea, and vomiting. Symptoms lasted 36-38 hours from the time of vaccination
50 2021-02-04 pain in extremity Sore arm; headache; This is a spontaneous report from a non-contactable consumer. A 50-year-old fema... Read more
Sore arm; headache; This is a spontaneous report from a non-contactable consumer. A 50-year-old female patient received received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 20Jan2021 for COVID-19 immunization. Medical history and concomitant drugs were unknown. On 20Jan2021 the patient experienced sore arm and headache. No treatment for the events was received. At the time of reporting the patient was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained
50 2021-02-04 tingling ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient... Read more
ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient evaluated. Peripheral IV established labs obtained. I do have concern for adverse reaction secondary to the vaccine as her symptoms started she said shortly before an hour after receiving the vaccine is started with tingling in her tongue throat and her body. She has minimal cardiac risk factors. Given she was tachycardic she cannot be perked out. EKG obtained showed no acute ischemic ST elevation or depression. Initial troponin was not elevated. Patient received 500 mL bolus of normal saline she deceived Benadryl and part of Pepcid. While the Benadryl infusion was going on patient reported feeling lightheaded and her heart rate was noted to increase to the 130s briefly. The medications were stopped, the Benadryl had already finished however the Pepcid was not completed. Her heart rate proved quickly and the lightheadedness resolved. Repeat EKG obtained did show some mild ST depression inferiorly. A repeat troponin obtained at 2 hours remain negative D-dimer was elevated to 91 therefore CTA chest was obtained. This showed no evidence of pulmonary embolism there is small groundglass opacity left upper lobe which is likely related to atelectasis do not feel that this is infectious in etiology patient has not had cough fever or chills. She remained on cardiac monitor here without any further tachycardia and her symptoms had resolved. I do believe patient's presentation is secondary to adverse reaction to the vaccination. She was advised to take Benadryl at home and may also try over-the-counter Pepcid at home for her symptoms. Did not feel that steroids were warranted at this time. She is to follow-up closely with her primary care provider. I did advise if she has new or worsening symptoms she should return to the emergency department and she expressed understanding and agreement with this plan.
50 2021-02-05 weakness 2/5/2021 @ 1:00 AM vomited X2, chills, body aches, fever 100.6, HA, fatigue, watery eyes, weakness, ... Read more
2/5/2021 @ 1:00 AM vomited X2, chills, body aches, fever 100.6, HA, fatigue, watery eyes, weakness, sweating, and nausea for 30 hours. Feel weak and tired now.
50 2021-02-05 feeling hot, flushing Client complained of feeling hot and flush. BP 128/80, P68-70, BS 67. EMS evaluated. Client given ... Read more
Client complained of feeling hot and flush. BP 128/80, P68-70, BS 67. EMS evaluated. Client given water and snack and felt better.
50 2021-02-05 numbness and pain in extremities, tingling Acute lower back/sacral pain without sciatica-MD diagnosis. Mild tingling neuropathy to thighs and ... Read more
Acute lower back/sacral pain without sciatica-MD diagnosis. Mild tingling neuropathy to thighs and acute constipation. Began 02/01/21, early am. Advil 400 mg q 6 hours, Salon pas patch and heating pad provided some relief. Mirilax and prunes gave some relief from constipation. MD seen on 02/05/21 and above dx given. Flexeril 5mg given for spasms and Methylprednisolone 4mg tapered dose for inflammation. To follow up with MD after 02/11 if no relief or change in condition.
50 2021-02-05 pain in extremity Several symptoms - achy, chills, low grade fever - present 2/5/2021 loose bowels, sore arm - presen... Read more
Several symptoms - achy, chills, low grade fever - present 2/5/2021 loose bowels, sore arm - present 2/5/2021 and still present 2/6/2021
50 2021-02-06 weakness, feeling hot, tremor Feeling "HOT", given crackers & water, began to experience weakness. began SOB. EPE was administered... Read more
Feeling "HOT", given crackers & water, began to experience weakness. began SOB. EPE was administered 0.3 ml X 1 dose. Began shaking reported feeling better. 911 called to transport to hospital and patient notified that she can't take the 2nd Covid dose, O2 was administered while waiting for EMS. 11:34AM arrived report given.
50 2021-02-06 cold sweat, speech disorder Immediately after 2nd injection, sensitivity to light & color. Hot and sweaty for 24 hours, then col... Read more
Immediately after 2nd injection, sensitivity to light & color. Hot and sweaty for 24 hours, then cold & clammy, jumbled though and speech. Soreness at injection site. Extreme tiredness. 2-days after injection, swelling of piriformis muscle in hip, extreme pain, bedridden, unable to walk, fever, for going on 36 hours. Taking 800 mg ibuprofen to sleep. Muscle cream, Epson salt baths to reduce pain.
50 2021-02-06 muscle spasms Severe stomach cramping and diarrhea: Began at 4:30 pm 02.03.2021 - 02.07.2021 required hospital ER... Read more
Severe stomach cramping and diarrhea: Began at 4:30 pm 02.03.2021 - 02.07.2021 required hospital ER visit for iv fluids to treat stomach pain, nausea and dehydration from diarrhea. Sent home with prescription for Dicyclomine 20 mg tablet anti spasm medication. Petechiae on back of both hands, wrists and fingers: Began at 4:15 pm 02.05.2021 required hospital ER visit for multiple blood testing to evaluate platelets, etc. Testing clear and ER Dr. noted condition is associated with vaccination reaction and advised to closely monitor for any change and seek immediate return if continued progression and if so follow-up with hematologist. Foot cramps: Began overnight 02.04.2021, increased fluids and subsided. 99.8 Temperature: Began 02.04.2021 at 9:30 pm - to 11:30 pm and treated with extra strength Tylenol and subsided. Began 02.03.2021 at 10:30 pm -11:30 pm and treated with extra strength Tylenol and subsided. Soreness at injection site: Began 02.04.2021 ongoing treating with extra strength Tylenol.
50 2021-02-07 numbness Complained of numbness in left arm from injection site to finger tips. Subsided within 30 minutes. ... Read more
Complained of numbness in left arm from injection site to finger tips. Subsided within 30 minutes. Applied ice to area with improvement. Subsequently patient followed up with her PCP for recurring, transient numbness. Diagnosis: brachial plexus neuropathy of left upper extremity
50 2021-02-07 tingling I had an initial feeling of being high. My vision became distorted. My fingers became tingly. My b... Read more
I had an initial feeling of being high. My vision became distorted. My fingers became tingly. My breathing felt heavy. I felt heavier and heavier. They asked me if I wanted to lay down. I said yes. I was also very dizzy. My blood pressure was 135/83 and pulse was 125. my blood sugar was 102. I drank a bottle of water and laid down for 20 to 30 mins. Then sat in the chairs. I had to wait for the vision disturbance to wear off so I could drive. it also gave me ADD symptoms for 48 hours. Very hyper. Then I had the flu for 5 days. The dizzy wore off on the 6th day. Should I get the 2nd shot?
50 2021-02-07 tremor Shakes, severe chills, temp 101.4 extreme fatigue and malaise. Headache, body aches, not smell or ta... Read more
Shakes, severe chills, temp 101.4 extreme fatigue and malaise. Headache, body aches, not smell or taste. Tylenol, fluids Motrin, rest shower and than heated blanket set to high to try and get warm
50 2021-02-08 discomfort I started with chill, fever of 101, head ache, tired, nauseated, achy for two days, the third day se... Read more
I started with chill, fever of 101, head ache, tired, nauseated, achy for two days, the third day severe stomach cramps from 10:00 AM to 6:00 PM, no appetite during that time, no diarrhea, the next day head ache, tired, heaviness on my head, tired, this lasted for three days. During the fourth day started perceiving a strange smell on and off, it has been 14 days and still have the smell like someone is smoking a cigar rate while in a toilet pooping. I have never smoke and hate the smell of smoke. This last symptom has been driving me insane. This is the only symptom since vaccine is lingering and is bothersome. My next shot will be on Monday the 15 of February, and I am concern, haven't been able to reach the Health Department to report or make questions, called my physician and she is out of the country, reported to the Medical Assistant who answered the phone. I only took motrin and Tylenol during the six days with the first side effects, have done nothing about the smell that is still there.
50 2021-02-08 feeling hot, weakness hot, sweaty, sick. could not get out of bed. Weak rest of day. following week-between 10a and 12p, g... Read more
hot, sweaty, sick. could not get out of bed. Weak rest of day. following week-between 10a and 12p, got really hot, heart beat really fast. 1/24-sitting on couch doing nothing, watching TV, chilling. Heart rate was between 106-110. Saw doctor, next day. All was fine. If happens again-do Holter 2/05, and echocardiogram 2/25. Holter-wear monitor for 2 wks. Current sx? just gets episodes-gets really hot, heart beats really fast, palpitations, chills, then ends. This is not all the time. 2/01/2021 ED-SVT. very intermittent, not concerned. do tests that doctor ordered. She has cont to work thru this.
50 2021-02-08 pain in extremity Received vaccine on 12/29/2020 around 11:15am. Approximately 7 hours later, developed left arm pain ... Read more
Received vaccine on 12/29/2020 around 11:15am. Approximately 7 hours later, developed left arm pain and left neck pain. 12/30 developed a small headache that progressed into a severe headache with nausea and vomiting. Went to ED on 12/30 at 12:04pm and discharged at 15:55. Received 0.9 % sodium chloride 999 mL, ondansetron 4 mg, CBC And Differential (Abnormal), Comprehensive Metabolic Panel (Abnormal), Lipase, acetaminophen 650 mg, SARS-CoV-2 NAT, IP UA w/Microscopic, Reflex Culture (Abnormal). Instructed to take ondansetron-ODT 4 mg disintegrating tablet by mouth every 8 (eight) hours as needed for nausea.
50 2021-02-08 pain in extremity Pain, swelling, formation of large, red, warm, lump, and unable to lift arm. Took over the counter p... Read more
Pain, swelling, formation of large, red, warm, lump, and unable to lift arm. Took over the counter pain relievers, tried cold and warm compresses. Redness, warmth, and lump resolved after 3 weeks. Still will left arm pain. Painful to lift and abduct arm.
50 2021-02-09 pain in extremity Very very sore arm. And extreme fatigue.
50 2021-02-09 pain in extremity After 12-18 hours: pain in right arm, shoulder, shoulder blade, neck. Headache. Fatigue. After 24 ho... Read more
After 12-18 hours: pain in right arm, shoulder, shoulder blade, neck. Headache. Fatigue. After 24 hours: fever of 100.6, headache (right-sided)
50 2021-02-09 pain in extremity Chills, arm pain, body aches
50 2021-02-10 weakness Fatigue for 12 days; severe pain to all joints especially knees and neck; severe pain to all joints ... Read more
Fatigue for 12 days; severe pain to all joints especially knees and neck; severe pain to all joints especially knees and neck; weakness; nausea; headache; feverish; swelling of left arm; malaise for 12 days; symptoms of pain lasted 12 days-I still don't feel 100%; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: e1 3246), via an unspecified route of administration at the left arm on 11Jan2021 at single dose for COVID-19 immunization. The vaccine was received in a nursing home. Medical history included seasonal allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 11Jan2021 04:00 PM, the patient experienced fatigue for 12 days, severe pain to all joints especially knees and neck, weakness, nausea, headache, feverish, swelling of left arm, malaise for 12 days, symptoms of pain lasted 12 days- I still don't feel 100%.The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. Events resulted to Doctor or other healthcare professional office/clinic visit. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 using Nasal Swab on 22Jan2021 and result was negative. The outcome of the events was recovering.
50 2021-02-10 facial paralysis Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a conta... Read more
Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EV1685, expiry date unknown) via an unspecified route of administration on the left deltoid, left arm, on 05Jan2021 08:15 AM at a single dose for COVID-19 immunization. The patient's medical history included allergies to Penicillin and Sulfa from an unknown date and unknown if ongoing. The patient had no current Illness and no family medical history. The patient is not pregnant. Concomitant medications included metoprolol tartrate, Vitamin C [ascorbic acid], Vitamin D3, and Multivitamins; patient received these medications within two weeks prior to the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Patient had a routine Physical Examination on Nov2020 and underwent lab tests and procedures on 24Jan2021 which included unknown BW and negative Lyme Disease Test. On 23Jan2021 18:30, the patient developed bell's palsy on left side which was reported as getting a little worse every day. The event required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care; the event resulted in Disability or permanent damage. Since 24Jan2021, patient received Prednisone 60 mg, daily for 7days and Valtrex 1g, 3x/day (TID) for 7days as treatment for the event. The patient did not recover from the event Bell's palsy on left side.' It was further reported that patient experienced soreness at the injection site on an unspecified date with outcome of unknown.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event Facial paralysis cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-02-10 feeling cold on first day felt vertigo and headache second day felt chillscold sore, fatigue, headache continued,... Read more
on first day felt vertigo and headache second day felt chillscold sore, fatigue, headache continued, joint pain. These symptoms lasted 5 days. skin felt sunburned all over and hurt to touch which lasted 2 days
50 2021-02-10 hypersensitivity of all senses I experienced a hyper-reactive immune response after receving the first dose of COVID-19 vaccine on ... Read more
I experienced a hyper-reactive immune response after receving the first dose of COVID-19 vaccine on Friday 12/18/20. On Saturday, 12/19/20, I developed severe pharyngitis, swollen glands in my neck and jaw, blisters and ulcerations on my lips and area surrounding my mouth, intra-oral and buccal lesions, severe headache, photophobia and eye pain, myalgia, skin sensitivity, GI upset consisting of nausea and diarrhea, and lost my sense of taste and smell for 48 hours. I was not febrile. The symptoms were severe on 12/19 and 12/20, with improvement on Monday 12/21. I completed an event form with Pfizer documenting the hyper-reactivity.
50 2021-02-10 pain in extremity Low grade fever began about 21 hours after shot. Very achy all over about 24 hours after shot. 36 ho... Read more
Low grade fever began about 21 hours after shot. Very achy all over about 24 hours after shot. 36 hours after shit the lymph nodes under my left arm began to swell and hurt. Over the course of the next 2-3 days after that, the nodes continued to swell and hurt down my arm past the elbow. A week after the shot it was all resolved
50 2021-02-10 tingling, flushing Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat ... Read more
Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat down immediately headache lump in throat then: tingling fingers , dizziness, swelling hands feet and face, flushed, turn bright & lump in throat bigger within 10 mins to the ER for treatment
50 2021-02-11 flushing Developed flush feeling and redness approximately 5 minutes after vaccination, then developed headac... Read more
Developed flush feeling and redness approximately 5 minutes after vaccination, then developed headache, dizziness, nausea. Tylenol 650mg PO x 1 given, benadryl 50mg PO x 1 given. Vital signs as follows, checked at 5-10 minutes intervals: BP 153/71, HR 94, SpO2 100% on RA; BP 187/88, HR 100, SpO2 100% RA; BP 136/70, HR 96, SpO2 100% RA. Pt discharged under stable condition with ER precautions.
50 2021-02-12 numbness, tingling Numbness tingling and shooting pains in bilateral arms starting day after each shot. Seems to be wor... Read more
Numbness tingling and shooting pains in bilateral arms starting day after each shot. Seems to be worse after second dose. Pain is worse. Feels like bone pain. Had fever, nausea, body aches, neck pain , ear pain, headaches, and chills starting 12hours after 2nd dose.
50 2021-02-12 migraine, pain in extremity Fever, headache, aches, migraine, sore arm and sore throat.
50 2021-02-14 feeling cold First started feeling very cold, then had shaking chills/ rigors for about 2 hours. Before rigors st... Read more
First started feeling very cold, then had shaking chills/ rigors for about 2 hours. Before rigors stopped had onset of headache. Had the worst headache I?ve ever had with fatigue and nausea for the next 24 hours. Felt better with symptoms resolved in approximately 36 hours.
50 2021-02-14 flushing She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vacc... Read more
She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vaccine she became flushed, within minutes she developed hives starting on her hands and then becoming more generalized, as well as itchy palms. She also was hypertensive. The COVID vaccine clinic administered epinephrine and transfer her to the emergency department where she was given prednisone, Benadryl, and famotidine. ED notes do indicate she had some mild expiratory wheezing but on further discussion with her today this is a consistent finding after being diagnosed with asthma last year (more on this below). She was monitored for over 3 hours and discharged home. Her itching resolved in the ED, hives resolved about 3 hours after discharge and other symptoms resolved around 24 hours post vaccine. She did have labs drawn in the ED: troponin and C4 WNL. CBC showed leukocytosis with lymphocytosis and eosinophilia. No personal history of seasonal, perennial, food, or bee sting allergies; asthma history as below. She did have an episode of bilateral eye swelling in December that was evaluated by her PCP; she was treated with benadryl & prednisone and this took 3 days to resolve. She has no other history of anaphylaxis, hives or angioedema. She was able to show me pictures of this today.
50 2021-02-14 pain in extremity 14 hours after the shot, experienced sore arm, fever, chills, and headache which subsided within 24 ... Read more
14 hours after the shot, experienced sore arm, fever, chills, and headache which subsided within 24 hours (except sore arm is still ongoing). Intermittent coughing is ongoing which is a new event.
50 2021-02-14 tingling ABOUT TWO DAYS AFTER THE VACCINATION, I NOTICE SMALL ITCHING SPOT ALL OVER MY BODY. TOP LIP WAS THE ... Read more
ABOUT TWO DAYS AFTER THE VACCINATION, I NOTICE SMALL ITCHING SPOT ALL OVER MY BODY. TOP LIP WAS THE MOST BOTHERSOME. BOTH MY FEET FELT LIKE NEEDLES FOR ABOUT 2HOURS. BUT EVEN TODAY, 2/14/2021, THE ITCHING HAS CONTINUED. DOES NOT ITCH TO THE POINT THAT MAKES ME WANT TO SCRATCH; BUT NOTICEABLE. BOTH ARMS AND LEGS MOSTLY. I HAVE NOT NOTICED A RASH. I HAVE NOT TAKEN ANY MEDICATIONS FOR THIS ITCHING. I AM HOWEVER WORRIED ABOUT TAKING THE 2ND DOSE. AS A MATTER OF FACT, I AM LEANING AGAINST TAKING THE SECOND DOSE.
50 2021-02-14 tremor, pain in extremity, nerve pain Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain... Read more
Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain in feet; Chronic neck and right shoulder pain/mid upper back; Chronic neck and right shoulder pain/mid upper back; Severe sweats from lung region up-censation of passing out; Severe nerve pain; Insomnia; This is a spontaneous report from a contactable nurse reported for herself. A 50-years-old female patient (non pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 13Jan2021 at single dose for COVID -19 immunization. Medical history included allergies to morphine,demerol, codiene, dilaudid, golytle, adhesive tape. Concomitant medication included flecainide (FLECAINIDE). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization on 23Dec2020 and experienced severe headache, lethargy, severe body aches, high fevers, COVID positive. The patient experienced severe headaches, heart palpatations, severe joint pain, tremors to hands, pain in feet, chronic neck and r shoulder pain/mid upper back, severe sweats from lung region up-censation of passing out, severe nerve pain, insomnia in Jan2021. It was reported as serious report, seriousness criteria was disabling/incapacitating. The adverse events result in doctor or other healthcare professional office/clinic visit. The events outcome was not recovered. Information on the lot/batch number has been requested.
50 2021-02-15 weakness, cold sweat Night of vaccine (2/13) headache and body ache; Morning after (2/14 am) site injection swollen, red,... Read more
Night of vaccine (2/13) headache and body ache; Morning after (2/14 am) site injection swollen, red, and hot. body was weak, headache; Night after (2/14 pm) nausea, headache, injection site swollen, hot to the touch, and red. lymph nodes swollen (right armpit); Two mornings after (2/15 am) throwing up (4 times), injection site more swollen, hot, swollen lymph nodes (right armpit), body was clammy; Two evenings after (2/15 pm) injection site swollen, hot, swollen lymph nodes (right armpit), body was clammy; Three mornings after (2/16 am) injection site swelling increased, red, hot, swollen lymph nodes (right armpit), redness line from site to right armpit into a red circle
50 2021-02-15 pain in extremity I had the usual arm soreness. Foot pain started on 22nd and worse on 23rd. Left foot hurt the most. ... Read more
I had the usual arm soreness. Foot pain started on 22nd and worse on 23rd. Left foot hurt the most. This foot was the one that hurt a little before vaccine. It was in the center of my foot where the arch is but inside the foot - an achy pain. It would shoot through my foot with pain if I stepped a certain a way. I was limping a bit. I tried to stay off my feet as much as I could. It continued through Christmas holidays. December 28 -(my PCP) - she thought it was tendonitis - could see a red circle and swelling where most of the pain was. Dec 28 - x-ray of foot was done. There was no fractures Meloxicam - anti-inflammatory 15 mg daily starting 12/28/2020. Pain continued - trouble walking and started having hip pain and left leg pain maybe from compensating. I saw Dr. on January 7th. He said it was posterior tibialis tendonitis. He gave me a foot brace to wear - around ankle and foot. It helped but I was still having pain. I was still taking Meloxicam every day. A chiropractor and a physical therapist -they gave me foot exercises and leg exercises and that has been helpful - I see them once a week still. Dr check-up on February 9 and he ordered an MRI and I had that done on February 11th. Report says Tendinopathy and not tendonitis. I got the second dose on January 8th.
50 2021-02-15 pain in extremity On the 10th, I started to feel achy that morning. It seemed like it had a focal point in my right hi... Read more
On the 10th, I started to feel achy that morning. It seemed like it had a focal point in my right hip and thigh that was a deep shooting pain. It continued to be there. I have been taking Tylenol - 1000 mg once a day and sometimes I skip it because I don't want to hurt my liver - so daily as needed. It seems like my foot pain got worse during the time after the second dose and the week after. At this time it has plateaued - not getting worse - as long as I walk on the side of my foot, I'm okay. Can't walk on it in a regular way. My right hip and thigh is a continuous ache unless I take Tylenol and sometimes that wakes me up. If I lose sleep I get a migraine. I see the chiropractor weekly and the physical therapist weekly.
50 2021-02-16 feeling hot, flushing flushing and feeling hot. No resp sx.
50 2021-02-16 flushing, speech disorder Flush face chest, swollen checks , lips, tongue, had issues talking
50 2021-02-16 numbness Fourteen minutes after the administration, I felt my right ear plugged and the left side of my face ... Read more
Fourteen minutes after the administration, I felt my right ear plugged and the left side of my face went numb. The reaction passed but at home the numbness continued intermittently for up to three days and at some point I also felt my lips swollen. What worries me the most is that I do not know if I should go to administer the second dose.
50 2021-02-16 pain in extremity Soreness in arm, extreme body aches, headache, low-grade fever, fatigue, Swelling in left armpit
50 2021-02-16 pain in extremity After the first shot I just had a sore arm and nauseous for 4 days. After the second shot I had a s... Read more
After the first shot I just had a sore arm and nauseous for 4 days. After the second shot I had a sore arm (significantly more than after the 1st), had a massive headache for about 24 hours, but woke up this morning (2nd day after the shot) with swollen nymph nodes under my left arm along with pain and tenderness. It hurts to lift my arm or have anything putting any form of pressure on it.
50 2021-02-17 feeling of body temperature change, weakness, cold sweat, feeling cold 6 hrs post vax and 48 hours post vax: injection site pain; 6 hrs post vax: headache/ 48 hours post ... Read more
6 hrs post vax and 48 hours post vax: injection site pain; 6 hrs post vax: headache/ 48 hours post vax: remaining symptoms headache; 24 hours post vax: as above plus extreme fatigue/ 48 hours post vax: extreme fatigue; 24 hours post vax: chills/inability to feel warm; 24 hours post vax: inability to feel warm; 28 hours post vax: hot and cold flashes/ 48 hours post vax: remaining symptoms hot and cold flashes; 28 hours post vax: as the above plus nausea; 32 hours post vax: as above plus vomiting/ 38 hours post vax: vomiting ended; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 48 hours post vax: general physical weakness and malaise; 48 hours post vax: general physical weakness and malaise; This is a spontaneous report from a contactable other Health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9261), via an unspecified route of administration on 28Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Workplace clinic. Age at vaccination was 50-years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0142) administered on 07Jan2021 (at the age of 50 years), at single dose in left arm. Medical history included anxiety, depression, obesity. The patient has allergies to certain unspecified antibiotics. Concomitant medications included citalopram, linum usitatissimum seed oil (FLAX SEED OIL), daily multivitamin 50+. It was reported that 6 hrs post vax on 29Jan2021 the patient experienced injection site pain, headache, 24 hours post vax: as above plus extreme fatigue, chills/inability to feel warm, 28 hours post vax: as the above plus nausea, hot and cold flashes, 32 hours post vax: as above plus vomiting, 38 hours post vax: vomiting ended, otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body, 48 hours post vax: remaining symptoms headache, injection site pain, hot and cold flashes, ex-treme fatigue, general physical weakness and malaise. The events were reported as non serious. No treatment was received for the events. The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
50 2021-02-17 pain in extremity Please see weekly and daily updates. They are about 1 week behind timeline. Sxs started same day. Va... Read more
Please see weekly and daily updates. They are about 1 week behind timeline. Sxs started same day. Various sxs from high fever 103.1, body pains to complete spine, hips, various toes and left lower back over kidney felt sore.. Now shoulders hurt. Asked job for FMLA forms.
50 2021-02-18 feeling hot chills started about 8 hrs after 2nd dose injection; waking up with body aches, headache and continu... Read more
chills started about 8 hrs after 2nd dose injection; waking up with body aches, headache and continued chills - going from chilled to warm. No fever yet.
50 2021-02-18 numbness, bell's palsy, facial pain, facial paralysis On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling rig... Read more
On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling right. There was a pressure in my head, along with sinus and ear pain and a fuzzy feeling in my face. By Monday, Feb, 1, 2021, the pain was worse now with a fatigued feeling after sleeping 20 of the last 24 hours. I went to my Dr on 2/1/2021 and recognized a slide on the left side of my face. From my forehead not wrinkling up the same as right side, left eye wasn't closing as tight and the left cheek and side of mouth were sliding. He said it was Bells Palsy. He prescribed 10 days of prednisone and an antivirus medicine to be taken 3 times a day. That week I slept a lot and wasn't able to sit up much due to the head pain and the lightening bolt feeling in my face. By the 2nd week I was able to sit up more, but still very tired/fatigued. I was off work for 2 weeks, returning to work on 2/14/2021. There is still a slight slide on the left side in the eye and cheek.
50 2021-02-19 numbness, pain in extremity Nausea, tired, fever, sore arm, rolling chills, headache the arm was sore after about two hours the ... Read more
Nausea, tired, fever, sore arm, rolling chills, headache the arm was sore after about two hours the fever and tired started about 3:30 and the chills, fever and headache were all night long, the next day I was tired and still had a fever but had take Tylenol to help with symptoms. By Friday morning I was feeling better from the above symptoms but had a weird numbness in my fingers on Friday afternoon that is still there today.
50 2021-02-21 pain in extremity, night sweats, feeling of body temperature change dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, ni... Read more
dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, night sweats, severe fatigue, sinus congestion, runny nose, post nasal drip, sore arm
50 2021-02-21 pain in extremity sore arm; other vaccine same date vaccine date: 01Feb2021; This is a spontaneous report from a conta... Read more
sore arm; other vaccine same date vaccine date: 01Feb2021; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 01Feb2021 15:15 (lot number: EL3248), via an unspecified route of administration in the right arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history includes ulcerative colitis, shellfish allergy, sulfa allergies unknown if ongoing from an unknown date. The patients historical drug included benzthiazide (REGULON) which caused allergies. Patient received the first dose of BNT162B2 (lot number: EL3248) on 13Jan2021 14:15 in the left arm for COVID-19 immunization. Concomitant medications included tofacitinib citrate (XELJANZ) and cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D). The patient was administered with other vaccine on same day i.e. 01Feb2021. However, it was also reported that the patient did not receive any other vaccine within four weeks. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient experienced sore arm on 02Feb2021 05:00 AM. The patient did not received treatment. The consumer assessed the events as non-serious. The outcome of the sore arm was recovered in Feb2021. No follow-up attempts are possible. No further information is expected.
50 2021-02-21 tingling, flushing Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling do... Read more
Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling down right side. Also had mild muscle aches and a headache. Had a similar reaction on her first dose. Oxygen: 97% on room air, BP109/57 and HR 54. Pt declined Benadryl and was taken to ED for further evaluation,
50 2021-02-22 feeling hot C/O feeling warm all over and developed a red lacy rash on trunk and extremities. Benadryl 25 mg ta... Read more
C/O feeling warm all over and developed a red lacy rash on trunk and extremities. Benadryl 25 mg tablet PO was given. BP taken.
50 2021-02-22 flushing, tingling Arm burning from the inside out from injection site right after injection; headache; tingling hand a... Read more
Arm burning from the inside out from injection site right after injection; headache; tingling hand and feet; swelling hands feet and face; swelling face; flushed; red all over wheel down to ED; lump in throat; Low blood pressure; high resting heart rate; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e10140), via an unspecified route of administration at the left arm on 11Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included psoriatic arthritis, and allergies to shellfish, sulfa, bees, and, kiwi. The patient was not pregnant at the time of vaccination. Concomitant medication included naproxen sodium (ALEVE) and estradiol (ESTROGEN). The patient previously took naproxen (NAPROSYN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm burning from the inside out from injection site right after injection on 11Jan2021 9:15. Seconds later the patient experienced headache, lump in throat, tingling hand and feet, swelling hands, feet, and face, flushed, red all over wheel down to Ed, low blood pressure, and high resting heart rate all on 11Jan2021. The events resulted in emergency room/department or urgent care. Treatment was received for the all the events reported as IV with added therapy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect product administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-02-22 numbness The next day after receiving the vaccine, at 9:15 am her hand became numb and she was unable to cont... Read more
The next day after receiving the vaccine, at 9:15 am her hand became numb and she was unable to control or move it. She could not grip the steering wheel or hold anything. She shook her hand and it returned to normal. At 10:15 itjhappened again. It happened a few more time while at work. She also had a few epidsodes in which her jaw became slack and off to the side and she had to close her mouth with her hand, because she could not control her jaw. The episodes lasted about 10 seconds and then they would disappear. She reported her symptoms to the us at about 12:30 PM, 2/23/2021.
50 2021-02-22 muscle spasms Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in gl... Read more
Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in glands under arm. Muscle spasms in arms and chest. Slight nausea.
50 2021-02-22 night sweats, weakness Developed symptoms of COVID-19 and tested positive with PCR test for COVID-19 on 1-29-2021. Symptoms... Read more
Developed symptoms of COVID-19 and tested positive with PCR test for COVID-19 on 1-29-2021. Symptoms included cough, rhinorrhea, sore throat, sinus congestion, severe headache, weakness, body aches, N/V/D, fever, chills, night sweats, abdominal pain. Was quarantined for 10 days post symptom onset.
50 2021-02-23 facial paralysis Bell's Palsy; This is a spontaneous report from a contactable healthcare professional. A 50-year-old... Read more
Bell's Palsy; This is a spontaneous report from a contactable healthcare professional. A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiry date: unknown), via an unspecified route of administration on 21Jan2021 (at the age of 50 years old) at a single dose for covid-19 immunization. Medical history included hypertension, gastrooesophageal reflux disease (GERD), obesity, and allergies: sulfa. Concomitant medications included hctz, escitalopram oxalate (LEXAPRO), losartan, metoprolol and omeprazole (PROTONIX [OMEPRAZOLE]). The patient is not pregnant. The patient had no other vaccine in four weeks and was not tested for covid post vaccination. On 09Feb2021, the patient experienced Bell's palsy. Therapeutic measures were taken as a result of the event Bell's palsy included prednisone and valacyclovir. Outcome of the event was not recovered.
50 2021-02-23 pain in extremity Throbbing arm pain; Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from ... Read more
Throbbing arm pain; Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), intramuscular in left arm, on 18Dec2020 at 09:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history included asthma, chronic back pain (surgery and scoliosis), migraines, systemic reaction to allergy injection, and COVID-19 in Jun2020 (prior vaccination). The patient's concomitant medications included pregabalin (LYRICA), butalbital, ascorbic acid (VITAMINS C), biotin, boron/ calcium/ Cimicifuga racemosa extract/ folic acid/ Glycine max extract/ Magnolia officinalis/ nicotinic acid/ pyridoxine hydrochloride/ riboflavin/ selenium/ thiamine/ tocopherol/ vitamin B12 NOS (ESTROVEN), Linum usitatissimum seed oil (FLAXSEED OIL), paracetamol (TYLENOL ARTHRITIS), and an unspecified stool softener and D (unspecified). The patient previously took amoxicillin and cinnamon oil and experienced allergies to both. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 18Dec2020 at 08:00 PM, the patient experienced throbbing arm pain for 2 days, fever, chills, body aches, headache, and fatigue for 2 days - some of the same symptoms she had when she had COVID-19 back in Jun2020. The events were considered non-serious. Treatment was received for the adverse events including ibuprofen, paracetamol (TYLENOL), and famotidine/ ibuprofen (DUEXIS). Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from "Throbbing arm pain" and "Fatigue" on 20Dec2020, and from the remaining events on an unspecified date.
50 2021-02-23 pain in extremity back pain; bilateral leg pain; This is a spontaneous report from a contactable other health professi... Read more
back pain; bilateral leg pain; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 123302), via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ergocalciferol (VIT D) and an unspecified vaccine (lot number: P 100242861) taken for an unspecified indication on 01Dec2020. The patient previously took the first dose of BNT162B2 (lot number: EL0140), at 50-years of age via intramuscular route, on 30Dec2020 at 03:30 pm on the left arm for COVID-19 immunization and four days after the injection, patient had severe low back pain, difficulty walking, standing, sitting. The patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date, the patient experienced back pain along with bilateral leg pain. The patient did not receive any treatment for the reported events. The patient underwent lab test which included nasal swab test which showed negative result on 21Jan2021. The outcome of the events was recovering. The patient was not pregnant at the time of vaccination.
50 2021-02-24 feeling hot I waited the recommended 15 minutes after my vaccine and felt okay. When I got to my car, my face f... Read more
I waited the recommended 15 minutes after my vaccine and felt okay. When I got to my car, my face felt very hot and was flushed and the right side of my tongue felt thick for a day or more. Yesterday was one week ago from my vaccine and my tongue intermittently still feels thick. My tongue feels like it does when novocaine starts to wears off from the dentist. My right arm also felt sore and puffy; however, there was no skin reaction. The next day or so the right side of my neck was sore. As to be expected, my arm was also sore.
50 2021-02-24 pain in extremity Painful joints - ankles, knees, hips, shoulder, elbows, wrists, and fingers Fatigue Painful swelling... Read more
Painful joints - ankles, knees, hips, shoulder, elbows, wrists, and fingers Fatigue Painful swelling of lower legs and ankles
50 2021-02-24 tenderness Severe back pain, unbearable to sit or lean back, painful to the touch. Took Advil 24 hours after ha... Read more
Severe back pain, unbearable to sit or lean back, painful to the touch. Took Advil 24 hours after having the vaccine.
50 2021-02-24 tenderness On one week follow-up visit to both urgent care and the emergency room, my primary care doctor notic... Read more
On one week follow-up visit to both urgent care and the emergency room, my primary care doctor noticed that my symptoms occurred less than 48 hours from my vaccine. I received the vaccine approximately 3:00 pm on Saturday February 13. At 11 am on Monday February 15 started feeling pain and tenderness on lower left side which was intermittent and worsend by nightfall. The next day on Tuesday February 16 I went to the urgent care and then they sent me to the ER in which epiploic appendigitis was determined to be the cause. Sent home to a course of ibuprofen and rest because the condition self-corrects.
50 2021-02-25 migraine Shaking chills, Fever, Muscle aches and pain, joint pain, migraine
50 2021-02-25 pain in extremity Received first covid vaccine 1/17/21 to the right deltoid (Pfizer, lot #EL3248). On 1/27/21 seen by ... Read more
Received first covid vaccine 1/17/21 to the right deltoid (Pfizer, lot #EL3248). On 1/27/21 seen by an APNP for right arm pain and decreased mobility. Presented to EHS on 1/29/21 with pain and concern that vaccine was give posterior to the deltoid. Pt did not take pictures or get seen around the time of her vaccine. So, 12 days later, unable to verify exact placement of the vaccine back on 1/17/21. Per the APNP's report on 1/27/21, the pt developed sharp shooting pain into the right trap/scapular area and radiation to lower arm. The pain started within a few seconds after the covid-19 vaccine was given. Feels soreness and tension in the shoulder/scapular area which has not resolved since vaccine. Pt advised continue supportive cares, trial diclofenac gel, use oral NSAIDs cautiously, apply heat. Follow up with EMG (scheduled for 4/14/21). Pt was also given a prescription for cyclobenzaprine. Per documented telephone encounters, as of 2/26/21 pt continues to have significant pain. Note: Pt received her second covid-19 vaccine on 2/13/21 in her left deltoid and there has been no mention of issues with pain in the left arm (Pfizer, lot #EN5318)
50 2021-02-25 tingling subjective 50 yo female presenting for 2nd covid vaccine with h/o anxiety a/w tingling in left hand ... Read more
subjective 50 yo female presenting for 2nd covid vaccine with h/o anxiety a/w tingling in left hand 15 min after first covid vaccination which resolved during a 30 min observations period . Again, approximately 15min after the 2nd covid vaccination c/o tingling without weakness in the palm of left hand a/w anxiousness Pt denies swelling in hand, no rash, no flushing, no swelling sensation in face or neck, no globus no sob no wheezing no chest pain no palpitation no gi sx no headache no altered mentation or brain fog Objective Pulse 63 bp=154/103 rr 12 temp afeb Heent wnl Neck wnl Chest clr p&a Cor rrr Neuro grossly intact Skin clr Assessment/plan Anxiety with psychosomatic features and elevated bp due to hyperadnergic state from anxiety. Pt reassured being observed by physician and pt reclined in a quiet room. Repeat vital signs were p 64 bp 150/89 and p 62 bp 120/85 repectively d . pt discharged home with resolution of left hand paresthesia and normalized vital signs
50 2021-02-26 concussion Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle a... Read more
Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle and concussion. Transported to nearest hospital, I had to have emergency surgery on left ankle, by Dr. A plate and screws were placed in my ankle to stabilize the break. I am being treated and monitored by my general doctor for the concussion. I am currently non-weight bearing on my ankle, for a minimum of 2-4 weeks. I am unable to work due to the ankle break and concussion, for an undetermined amount of time. I am scheduled to meet with Dr. on the 4th of March, at which time he stated he will want to begin physical therapy, once the break has reached an adequate stage of healing. I will be re-evaluated by my general Dr. for the concussion in 2 weeks.
50 2021-02-26 muscle spasms, burning sensation, numbness, sciatica Sciatic nerve pain, burning, numbness, muscle cramping - started 2/20/21 in lower left back, travele... Read more
Sciatic nerve pain, burning, numbness, muscle cramping - started 2/20/21 in lower left back, traveled across left buttocks on 2/22/21, continued to left outer thigh on 2/23/21, continued to left lower leg and foot on 2/24/21. Loss of ability to walk properly due to left leg/foot pain and numbness which resulted in loss of contorl of left leg and foot on 2/24/2021. No prior history of injury or problems of this nature.
50 2021-02-26 pain in extremity, migraine 2/24/21 Injection Site arm soreness (8 hours) 2/25/21 - Right arm pain, nausea, body aches (12 hou... Read more
2/24/21 Injection Site arm soreness (8 hours) 2/25/21 - Right arm pain, nausea, body aches (12 hours) stomach pain (6 hours) Migraine-like headache (8 hours) 2/26/21 Tired 8 hours
50 2021-02-28 feeling cold, tingling her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high bloo... Read more
her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high blood pressure; possible allergic reation; a cool, tingling sensation in her legs; a cool, tingling sensation in her legs; Heart rate increased; she numbness in her top lip; she had a tingling at the top of her head; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 and expiration date May2021, right arm on 25Jan2021 Administered between 16:00-16:15 PM as single dose (at the age of 50 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Retinitis pigmentosa from 2016, and breast cancer in Dec2015, she is in remission. Went through chemotherapy and reconstructive therapy. She has a family history of breast cancer. Additionally, patient has history of panic attack, supplementation therapy and eye disorder vitamin (she saw her eye doctor in Dec2020, and he recommended she start taking the eye vitamin. She said she started the eye vitamin in the end of Dec2020). The patient has historical vaccine information including flu vaccine Sep2020. Concomitant medication includes lysine;zinc (LYSINE;ZINC) as supplementation therapy from Dec2020 and ongoing, xantofyl, zeaxanthin, (LUTEIN-ZEAXANTHIN), as eye vitamin Dec2020, ascorbic acid (VIT C), acetylsalicylic acid (baby aspirin) and probiotics (PROBIOTICS). The patient experienced a cool, tingling sensation in her legs on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), heart rate increased on 25Jan2021 with outcome of recovered on 25Jan2021 (She said she thought maybe her rapid heart rate was from her nerves because she was getting her first COVID-19 Vaccine dose), she numbness in her top lip on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), she had a tingling at the top of her head on 25Jan2021 with outcome of recovered, her legs kind of felt like they do when her legs go to sleep on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, heart palpitations on an unspecified date with outcome of unknown, high blood pressure on an unspecified date with outcome of recovered. She said the nurse suggested she talk to a medic located in the back are of where the COVID-19 Vaccines were being administered. She said she talked to medic. She said at that point it was probably about 25 minutes after she received the COVID-19 Vaccine. She said she never had allergies, and had no problem with the flu vaccine. She said she has had issues with anesthesia in the past, and if she is given the wrong type of anesthesia, she can get nauseous. She said the medic took her heart rate, and her heart rate was 154-ish. She said her heart rate was high, but sometimes for her, that is the case. She said the medic asked her how her breathing was. She said her breathing was OK, and could swallow fine. She said when the medic rechecked her heart rate, her heart rate was still the same. The medic said she has two things he can do: she can go to get Benadryl, or she can get checked out by a doctor. She said she wanted to see a doctor. She said she was brought to an Urgent Care to see a doctor. She said her heart rate was still elevated. She said the urgent care staff did a finger prick test (clarified as a blood sugar finger stick test), and she was told the finger prick test was fine. She said the doctor did an EKG, and her EKG was fine. She said the Urgent Care doctor eventually gave her Benadryl. She said after she took the Benadryl, her top lip was not numb, and her legs were fine. She said that was about 3 hours after receiving the COVID-19 Vaccine. She said the doctor felt she had a panic attack. She said she has had one panic attack in the past, and knows what a panic attack feels like. She said she maybe had some anxiety. She said her symptoms didn't seem like a panic attack because she wasn't having difficulty breathing and she wasn't short of breath, but she was somewhat nervous. She said she was not sure what to do, so she contacted her family doctor to see what she should do when she goes for her second COVID-19 Vaccine dose. She said the Urgent Care doctor gave her a prescription for Hydroxyzine Pamoate 25mg capsule, 1 capsule three times daily, as needed, for anxiety. She said her doctor told her the Hydroxyzine Pamoate is used for allergic reactions, as well. She clarified when she was at the urgent care her heart rate went down, and the nurse at the urgent care gave her 2 Benadryl pink capsules. Reported she took Benadryl when she got home because she was afraid she was having an allergic reaction to the COVID-19 Vaccine. Outcome of possible allergic reaction was unknown. She said she had a great night sleep, and the next morning took her first dose of the Hydroxyzine Pamoate 25mg. She said her primary care doctor suggested she take the Hydroxyzine Pamoate 25mg an hour before she gets the second COVID-19 Vaccine dose. The patient underwent lab tests and procedures which included blood sugar finger stick test: 117 on 25Jan2021, electrocardiogram: normal on 25Jan2021 said the doctor did an EKG, and her EKG was fine, heart rate: 154-ish on said her heart rate was high. She said her heart rate was still elevated. Therapeutic measures were taken as a result of a cool, tingling sensation in her legs, she numbness in her top lip, she had a tingling at the top of her head.
50 2021-02-28 flushing, tremor Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: All... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
50 2021-02-28 pain in extremity 1st - arm pain and heaviness from shot - 1 day after shot - took Tylenol 2nd - mild itching on face ... Read more
1st - arm pain and heaviness from shot - 1 day after shot - took Tylenol 2nd - mild itching on face and head - 3 -4 days after shot - did not recognize it as a reaction - no treatment given 3rd - difficulty breathing, asthma attack, full body covered with hives - 5 days after shot - took Benadryl for 24 hours - went to urgent care the next morning and was given steroid medication to take each day for a week, directed to continued to take Benadryl until steroids stop the hives 4th - second respiratory reaction with coughing and difficulty breathing - took an extra Benadryl.
50 2021-03-01 numbness Roughly 25 minutes after receiving the vaccine, I experienced numbness in my face (both sides). It ... Read more
Roughly 25 minutes after receiving the vaccine, I experienced numbness in my face (both sides). It lasted approx. 1.5 - 2 hours. No treatment was sought as there were no issues with breathing. The feeling returned to normal on its own.
50 2021-03-01 pain in extremity, migraine, numbness dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purp... Read more
dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purple on the center of it; My legs were hurting like really heavy; I have not gone back to sleep and I feel like a bus hit me.; chills; the body ache; legs hurt really bad; fever; symptoms associated with the flu for a few days; feeling like really bad headache; nauseated; not feel so good; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: unknown), via an unspecified route of administration from 28Jan2021 to 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included verapamil for blood pressure. The patient received her first dose of BNT162B2 on 08Jan2021 and experienced arms a little sore. On 28Jan2021 at 18:00, the patient started feeling like really bad headache and then really nauseated. The patient took medicine and took Tylenol before went in to take her shot and started getting a headache again and not feel so good. On 29Jan2021 at 02:00, the patient stated that her legs were hurting like really heavy and had not been back to sleep since 2 o clock in the morning and she felt like a bus hit her. On 29Jan2021 at 11:00, the patient stated that her finger on the left side was numb and it has a little bit of purple on the center of it. On 29Jan2021, the patient experienced chills, body ache, her legs hurt really bad, fever, symptoms associated with the flu for a few days. On 30Jan2021, the patient experienced arm swollen. On 01Feb2021, the patient experienced dizziness and migraine. The patient already took Tylenol and ibuprofen. The outcome of the event chills, fever, flu symptoms, arm swollen was recovered on an unspecified date and the outcome of the other events was unknown.
50 2021-03-01 pain in extremity fever and severe body aches and chills , body aches pfizer - no problems / first vaccine no problem-... Read more
fever and severe body aches and chills , body aches pfizer - no problems / first vaccine no problem- sore arm only
50 2021-03-01 tremor Increased heart rate to 110 bpm within 15 minutes of vaccine, lasting for 40 minutes, headache with... Read more
Increased heart rate to 110 bpm within 15 minutes of vaccine, lasting for 40 minutes, headache within 15 minutes of vaccine that lasted the whole day , dizziness and shakiness with in 15 minutes that lasted about 30 minutes.
50 2021-03-02 pain in extremity, tenderness Arm soreness. This morning my armpit is very tender, sore and swollen. Very swollen in gland area. S... Read more
Arm soreness. This morning my armpit is very tender, sore and swollen. Very swollen in gland area. Soreness down my arm.
50 2021-03-02 tingling, pain in extremity headache on right side of head; back went out from right side and cannot bend over; right leg hurts;... Read more
headache on right side of head; back went out from right side and cannot bend over; right leg hurts; right foot tingles; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the right arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (lot number: EK4176, administration time: 02:00 PM on left arm). The patient previously took levofloxacin (LEVAQUIN) and cefalexin (KEFLEX) and experienced allergies to medications. On 30Jan2021 10:00 PM, the patient experienced headache on right side of head, back went out from right side and cannot bend over, right leg hurts and right foot tingles. No fever. No treatment was received for the adverse events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
50 2021-03-03 hot flush nausea, hot flashes, aches, blood pressure drops and spikes, low oxygen, dizziness symptoms subsided... Read more
nausea, hot flashes, aches, blood pressure drops and spikes, low oxygen, dizziness symptoms subsided with antihistamine lasted 2 hours
50 2021-03-04 weakness While in observation @ 4:25p, a pt stated she felt weak, and that her defibrillator went off. She ha... Read more
While in observation @ 4:25p, a pt stated she felt weak, and that her defibrillator went off. She has a hx of heart issues and that her defibrillator goes off several times a year when her HR goes above 118 for a certain sustained amount of time. EMT's evaluated the pt, pt was placed on a monitor by emts, refused oxygen, didn't agreed to go to the ER at first but agreed after speaking with EMT's. Brought to ER, husband who was in the car, was notified by police detail.
50 2021-03-04 pain in extremity Left forearm pain
50 2021-03-05 feeling cold 12 hours after injection fever, chills, ague, extreme fatigue lasting 12 hours. 15 hours later loss ... Read more
12 hours after injection fever, chills, ague, extreme fatigue lasting 12 hours. 15 hours later loss of taste & smell lasted for 6 hours. Ague & extreme tiredness lasted 48 hours
50 2021-03-05 night sweats Three hours post vaccine, onset of moderate headache, moderate body aches, moderate fatigue. Twelve ... Read more
Three hours post vaccine, onset of moderate headache, moderate body aches, moderate fatigue. Twelve hours post vaccine, onset of severe headache/body aches/fatigue/chills/night sweats. Treatment: 1000 mg acetaminophen every 6 hrs
50 2021-03-05 speech disorder On Sunday following vaccine my husband noticed that I had a lisp when I spoke and my tongue wanted t... Read more
On Sunday following vaccine my husband noticed that I had a lisp when I spoke and my tongue wanted to protrude out of my mouth sporadically. As the week has progressed, I now have trouble speaking without jumbling my words - have to stop and speak slowly to make sense
50 2021-03-05 tenderness Appx 24 hours after the injection, the site of injection started itching very badly and a bright red... Read more
Appx 24 hours after the injection, the site of injection started itching very badly and a bright red solid spot appeared and a lump that was sore to touch. Redness was just smaller than a quarter at first. That was about 5:10pm 3/5 and then appx 8-9 hours later, while sleeping, I developed a severe cough and my nose was completely stopped up. Eyes were itching with drainage too. My husband got up and gave me a Benadryl and that calmed everything down so I could sleep again. This morning, my eyes were pretty red and still had some drainage. My cough is there but very faint and less frequent. My arm hasn?t stopped itching and the red spot is slightly larger at appx 1.5 inches tall and 1 inch wide. Still with a lump and soreness. I expected the lump and soreness.
50 2021-03-07 flushing 10 minutes after COVID vaccine was administered, pt reported facial flushing to pharmacy staff. Per ... Read more
10 minutes after COVID vaccine was administered, pt reported facial flushing to pharmacy staff. Per pt, her heart is pounding. RPh checked the blood pressure of the patient, blood pressure reading was 168/60, HR was 77. RPh spoke to another RPh in the store, RPh reported that BP was high for patient and per RPh if we administer EpiPen that can increase the patient's blood pressure even more. RPh gave the patient Benadryl 50 mg. RPh spoke to patient and patient's husband, he recommended to visit the nearest urgent care.
50 2021-03-07 flushing tongue tingling, throat and mouth feels swollen, flushing. Evaluated by EMS-Cleared
50 2021-03-07 migraine, pain in extremity Arm hurt immediately , few hours later severe sweats, fever ,severe migraine like headache , complet... Read more
Arm hurt immediately , few hours later severe sweats, fever ,severe migraine like headache , complete body ache lasted 2 days
50 2021-03-07 muscle spasms Body aches, joints pains, back pain, muscle cramps and headache
50 2021-03-07 pain in extremity Fever of 99.8 went up to 100 then holding steady at 99.3. Fever began around 1:20 PM and is still oc... Read more
Fever of 99.8 went up to 100 then holding steady at 99.3. Fever began around 1:20 PM and is still occuring at 8:30 PM on March 8, 2021. Also have a headache (like a sinus headache) and neck pain on the left side of the back of my neck. Typical arm pain/soreness from what others have described and feeling a little sluggish.
50 2021-03-07 pain in extremity Swollen lymph nodes in neck and armpit and this morning started having severe pain in my left thumb/... Read more
Swollen lymph nodes in neck and armpit and this morning started having severe pain in my left thumb/wrist
50 2021-03-07 pain in extremity "Pfizer-BioNTech COVID-19 Vaccine EUA" Around 5pm on March 7th, noticed my arm at site of vaccinatio... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" Around 5pm on March 7th, noticed my arm at site of vaccination was feeling more tender, hot, swollen, and red. In the night, I couldn't lay on that side. Stayed the same throughout March 8th, until 7pm, became increasingly sore. My entire arm is aching. The redness and swelling has also increased. I also have a headache started this evening.
50 2021-03-07 pain in extremity Sore Arm, about 1 hour after shot, lasting 3 days Tiredness, fatigue. Tiredness same day, lasting 5... Read more
Sore Arm, about 1 hour after shot, lasting 3 days Tiredness, fatigue. Tiredness same day, lasting 5 days. Fatigue 24 hours after-36 hours after (slept for 11 hours, day after shot) Headache 6 days
50 2021-03-07 tingling tingly sensation in my chin area; This is a spontaneous report from a contactable consumer (patient)... Read more
tingly sensation in my chin area; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284), via an unspecified route of administration on 15Jan2021 15:30 on left arm at single dose for covid-19 immunization. The facility type vaccine was hospital. Patient was not pregnant. Medical history included type 1 diabetes mellitus from an unknown date, Raynaud's from an unknown date. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included insulin glargine (LANTUS), insulin lispro (HUMALOG), lansoprazole. The patient experienced tingly sensation in chin area in Jan2021 with outcome of unknown.
50 2021-03-07 slow speech During 30 minutes observation after member received 1st dose of Covid-19 vaccine member stated she f... Read more
During 30 minutes observation after member received 1st dose of Covid-19 vaccine member stated she felt very sluggish. Member appeared listless and slow speech. Rapid response team/Adult emergency notified. Vitals obtained 124/76 Pulse 71, 100% RA. Member transferred to the health professional care via wheelchair.
50 2021-03-08 burning sensation, pain in extremity Left arm pain at site of injection, throbbing down the arm, burning sensation and heaviness. Inabil... Read more
Left arm pain at site of injection, throbbing down the arm, burning sensation and heaviness. Inability to raise arm and entire arm swollen. In addition to this on the first day of the adverse event flu like symptoms which lasted two days. Arm pain continues as at day four since adverse event started
50 2021-03-08 pain in extremity, tremor, feeling hot Minimal issues after 1st vaccine. After 2nd vaccine, about 8 hours later my arm hurt so bad I could ... Read more
Minimal issues after 1st vaccine. After 2nd vaccine, about 8 hours later my arm hurt so bad I could not sleep (2:30am) and taking Tylenol only cut the pain 50%. As time progressed that day about 12hours after injection I started to get the chills, achiness even after Tylenol which didn't do much. By 16 hours after injection I got hot/damp, shaky, nausea but once able to cool down nausea resolved. By 18 hours thru 28 hours I had difficulty walking due to achiness and extreme fatigue. Chills going on most of the time throughout and some looser stools. The next day 40h post injection I felt better-no chills. At 48h I was tired- no achiness, some looser stools. Day 3- I had some blood blowing my nose, resolved by day 4.
50 2021-03-09 weakness Caller is having a fever, nausea, and feels weak and wants to know if this is normal and what to do.... Read more
Caller is having a fever, nausea, and feels weak and wants to know if this is normal and what to do. She has taken Motrin to reduce her fever A. 400. Advised caller injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever can occur .Swollen lymph nodes and nausea have also been reported. Please seek medical attention if experiencing any shortness of breath, throat swelling, weakness, or diffuse body rash. TR
50 2021-03-09 weakness Fever, chills, severe muscle aches, severe headache, dizziness, weakness, loss of appetite 12 hours... Read more
Fever, chills, severe muscle aches, severe headache, dizziness, weakness, loss of appetite 12 hours post vaccine Chest pain/heaviness which led to some shortness of breath 32 hours post vaccine following temperature returning to normal Treated severe headache with Tylenol without relief
50 2021-03-09 feeling hot Patient reported to nurse that she was starting to develop hives. Upon inspection patient was seen t... Read more
Patient reported to nurse that she was starting to develop hives. Upon inspection patient was seen to have red blotchy hives on her neck and chest. She reported that it felt hot but not itchy.
50 2021-03-09 migraine First 3 days migraine ,fever, extreme pain all over. Could barely move injection arm. Still sore al... Read more
First 3 days migraine ,fever, extreme pain all over. Could barely move injection arm. Still sore all over currently.
50 2021-03-09 muscle spasms, weakness joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection s... Read more
joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection site pain; malaise; muscle cramping; swollen lymph nodes; projectile vomiting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration in right arm on 03Feb2021 15:45 at single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HTN), and gastrooesophageal reflux disease (GERD). Known allergies included xylometazoline hydrochloride (SUDAFED). Concomitant medication included omeprazole (PROTONIX), metformin hydrochloride, sitagliptin (JANUMET), empagliflozin (JARDIANCE), insulin glargine (BASAGLAR), escitalopram oxalate (LEXAPRO). There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced joint pain, weakness, chills, diarrhea, dizziness, minor difficulty breathing, headache, injection site pain, malaise, muscle cramping, swollen lymph nodes, projectile vomiting, all on 04Feb2021 09:15 with outcome of recovering. No treatment received for the events.
50 2021-03-09 muscle twitching, numbness Facial twitches and numbness (mild, on and off) on side vaccine was given. Warm feeling in throat an... Read more
Facial twitches and numbness (mild, on and off) on side vaccine was given. Warm feeling in throat and metal taste in mouth (both of these have gone). Twitches and mild numbness still happening.
50 2021-03-09 tenderness This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient (n... Read more
This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 05Feb2021 08:30 at the age of 50-years-old at single dose for COVID-19 immunization. Medical history included obesity, inflammatory lung disease. No known allergies. The patient's concomitant medications were not reported. The historical vaccine included BNT162B2 on 15Jan2021 at the age of 50-years-old for COVID-19 immunization. The patient experienced 6 out of 10 pain, tenderness and mass of some sort behind left collarbone pain radiating toward shoulder and neck, injection site minimally sore on 05Feb2021 20:00. Pain resolves with ibuprofen, no treatment received for the other events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information on the lot/batch number has been requested.
50 2021-03-10 tenderness I have had major swelling above my collarbone between my shoulder and neck on the left side, the sam... Read more
I have had major swelling above my collarbone between my shoulder and neck on the left side, the same side as I received my shot. It is tender to the touch. After four days, I can feel harder masses inside.
50 2021-03-11 weakness On day of shot, I was fine, more tired than usual by bed time. Next morning I was extremely weak an... Read more
On day of shot, I was fine, more tired than usual by bed time. Next morning I was extremely weak and fatigued not able to get out of bed for two hours. I went downstairs to get water, blacked out and completely fainted. I got out of bed around 10:25 or so, went downstairs very slowly, saw clock when I was able to get up around 10:47. I don't believe I was passed out for long. Woke up on kitchen floor, arm bruised. Thankfully head was not injured, apparently fell with arm supporting head (assumption since no head injury). Advised by nurse to come to dr. office, they tested blood pressure, top number was 82 (did the tilt test for orthostatic hypotension). EKG was normal and other blood tests were normal. Was diagnosed with dehydration and low BP. I habitually drink water and even if I did potentially skip a day, I should not faint.
50 2021-03-11 flushing Chest tightness and flashing with anxiety feeling immediately after the shot. Vital signs were stab... Read more
Chest tightness and flashing with anxiety feeling immediately after the shot. Vital signs were stable HR 86, Sat 98% RA, BP 107/75. Physical exam were unremarkable and she did not look in any acute distress she just felt anxious. Lungs clear to auscultation bilaterally. She was observed in the car for 30 minutes and was discharged home in stable condition. Denies any symptoms before discharge.
50 2021-03-11 tingling Increase heart rate 135, tingling hands and legs, complaint of swollen throat BP 158/85 called for a... Read more
Increase heart rate 135, tingling hands and legs, complaint of swollen throat BP 158/85 called for ambulance heart rate 93 heart rate 117 EMS arrived taken to hospital
50 2021-03-12 burning sensation, cold sweat Abdominal pain, vomiting, diarrhea, burning sensation in back and arms, clammy, chills, weak legs fr... Read more
Abdominal pain, vomiting, diarrhea, burning sensation in back and arms, clammy, chills, weak legs from about 4AM until 5:30 AM and then went to sleep. Woke up at 8:30AM and felt better
50 2021-03-13 pain in extremity I had severe flu like symptoms: headache and body aches, on and off fever. The injection site where ... Read more
I had severe flu like symptoms: headache and body aches, on and off fever. The injection site where my steroid shot was extremely sore, joints sore, nausea, acid reflux, constant urination and bowel movement, extreme dizziness and light-headedness.
50 2021-03-13 tingling tingling lips, one to two hours, subsiding to slight only on left side intermittently tingling left ... Read more
tingling lips, one to two hours, subsiding to slight only on left side intermittently tingling left side of tongue, one to two hours slighter tingling next to left eye, intermittent for days very strong metallic taste in mouth, subsided to slight metallic taste after a few hours
50 2021-03-13 tremor Violent shaking, chills, mild fever, about an hour
50 2021-03-14 weakness The next day after receiving vaccine I had weakness and fatigue. The second day after receiving vacc... Read more
The next day after receiving vaccine I had weakness and fatigue. The second day after receiving vaccine I could not move in the morning. I went to the ER both days. I was admitted to hospital at the second ER visit. I received 3 days of high dose IV steroids. Improvement of symptoms.
50 2021-03-14 feeling hot Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to... Read more
Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to sinus headache); after approximately 15 minutes, I experienced a ringing in my ears. I told the attending person, but she said it was probably due to being anxious about getting the shot. I left after being in the waiting area for 30 minutes and began driving home. My face felt very warm, so I opened the car window. I touched the side of my face and felt hives. My tongue felt thick, but I did not feel hives going down my throat. My torso started to itch and I had hives there as well. There was no raised area at the injection site. I became very itchy on my head, neck, and arms. When I arrived home, I took a dose of benadryl. Four hours later, I took a dose of zyrtec. My hives subsided and my tongue returned to normal, but I was still itchy. The next morning, I took a dose of claritin and called my doctor. In the afternoon, I took benadryl. In the evening, I took zyrtec. I continued this for 2 more days. The day after my vaccine, a node between my thumb and forefinger on my left hand was swollen and painful to the touch. My hand was swollen and my finger joints ached. I went to the doctor for an examination. The swelling and pain in my hand continued to worsen during the day and overnight. I kept ice packs on my hand and it felt better after 3 days.
50 2021-03-14 flushing, pain in extremity, tingling I was told by my doctor after talking with his office on the phone to report my reaction and that he... Read more
I was told by my doctor after talking with his office on the phone to report my reaction and that he is recommending that I NOT HAVE THE SECOND DOSE of this vaccine. On Tuesday March 9th I had my first dose of the Pfizer vaccine at our drive up site with the health department. I did not have any tylenol or claritin that morning and only took Tylenol that night. Starting the NIGHT of the 10th I started taking my usual Child's dose of Claritin for seasonal allergies. I took Claritin the nights of the 10th, 11th and 12th (thank goodness apparently). The only issue I had the 9th and 10th was REALLY SORE ARM. One the morn ing of Saturday the 13th I woke up and my neck was itching. Then my decollete area. Then my face and head and shoulders and the back of my arms. I felt like I was flushing after a steroid shot with the pin prickly itching and very very very slight pink color to my skin. Eventually by the evening the itch moved to my bra line. I called my local pharmacy (since the urgent care center was closed) and was told to take benedryl or claritin and keep an eye on it. The ADULT dose of Claritin really helped to calm the majority of the itching. I itched a little yesterday and still itch in spots today but the Claritin is helping as is topical Cortaid. The nurse said the claritin I had in my system probably prevented me from turning red. I have been told by two doctors that I should NOT take the second dose. ALL OF THE CONVERSATION WITH MY DOCTOR WAS DONE OVER THE PHONE.
50 2021-03-14 muscle spasms, pain in extremity Fine for 10+ hours. That evening, L arm really ached, really painful to lift above shoulder height. ... Read more
Fine for 10+ hours. That evening, L arm really ached, really painful to lift above shoulder height. Noticeably sore at injection spot. Joints started aching, tired, noticeably sore up through neck on L side. Was driving at night- distance vision was blurry (could have been dry eyes, not sure related to vaccine). Slept 14 hours. Woke with muscles still achy, not quite as much as day before. Neck still sore. Injection site only sore to touch. Still very tired, could have slept more. Woke up today, feel pretty normal. A bit tired.
50 2021-03-14 pain in extremity, hot flush Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes... Read more
Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes; low grade fever; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: Solution for injection and lot number: EL9265) via an unspecified route of administration on 03Feb2021 07:00 to Left arm at single dose for COVID-19 immunization. Patient medical history included Eosinophilia and colitis. Concomitant medications included Escitalopram, alprazolam and ibuprofen. Past drug included Wellbutrin and experienced allergy and first dose of BNT162B2 for COVID-19 immunization. On 03Feb2021 22:00 patient experienced Very large swollen lymph nodes in left armpit, neck, arm pain, headache, hot flashes, low grade fever still continues at 1 week after last dose. Seriousness was reported as non-serious. Patient did not receive any treatment for events. Outcome of events was not recovered. No follow-up attempts are possible. No further information was provided.
50 2021-03-14 tingling more intense tingling sensation around the chin area/lower mouth area; extreme dizziness; This is a ... Read more
more intense tingling sensation around the chin area/lower mouth area; extreme dizziness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, on left arm, on 06Feb2021 15:30 (at the age of 50-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included type 1 diabetes and Raynaud's, patient had no known allergies. No COVID prior vaccination. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), and lansoprazole, all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration, on left arm, on 15Jan2021 15:30 (at the age of 50-year-old), at single dose, for COVID-19 immunization, and after receiving the first dose the patient experienced tingly sensation in her chin area. After receiving the second dose on 08Feb2021 13:00 (reported as "day three") patient experienced more intense tingling sensation around the chin area and extreme dizziness. Patient took diphenhydramine hydrochloride (BENADRYL) and meclozine hydrochloride (BONINE) as a result. On 09Feb2021 (reported as "day 4") patient still experienced the tingly sensation around chin and lower mouth area. Patient felt almost like a sensation of when, for example: your arm fell asleep. It was constant. No COVID tested post vaccination. The outcome of the events was not recovered.
50 2021-03-15 discomfort, pain in extremity day of: queasiness, tightness at site of injection 1 day after: heaviness/weighed down, headache, qu... Read more
day of: queasiness, tightness at site of injection 1 day after: heaviness/weighed down, headache, queasiness, sore arm 2 days after: muscle aches, loss of appetite. night time: arm hurts 3 days after: loss of appetite, arm has raised rash about 3"x4" near the site of injection -hurts like a bruise, itchy, warm/hot 4 days after: rash symptoms same as above 5 days after: rash is beginning to dissipate, still itchy at times
50 2021-03-15 pain in extremity Achiness, fever, lethargy, chills, sleepiness within four hours of vaccine dose. Continued symptoms ... Read more
Achiness, fever, lethargy, chills, sleepiness within four hours of vaccine dose. Continued symptoms into following day. Symptoms subsided by 10:00 PM the day following the dose. Extreme soreness in arm even though it was moved and massaged to relieve the stiffness and soreness.
50 2021-03-15 pain in extremity 101 fever for 2 days now down to 99 fever very bad muscular pain for 2 days and still happening inte... Read more
101 fever for 2 days now down to 99 fever very bad muscular pain for 2 days and still happening intense headache unable to sit due to back pain could not sleep due to pain left underarm is VERY swollen
50 2021-03-15 tingling pt. experiencing tingling to the L. leg and warmth throughout the body. pt. advised to wait an addi... Read more
pt. experiencing tingling to the L. leg and warmth throughout the body. pt. advised to wait an additional 15 mins.
50 2021-03-16 discomfort, muscle twitching Patient was sitting in chair post-vaccine and initially complained of feeling lightheaded, nauseated... Read more
Patient was sitting in chair post-vaccine and initially complained of feeling lightheaded, nauseated and that her limbs were heavy. She was ambulated with assistance x2 to the exam table by the CNPs. She was laid in the supine position, feet elevated and given a cool cloth for her head. VS 150/96, HR 82 and regular, pulse ox 93% on room air. She was monitored for approximately 10-15 minutes, and the patient then stated that she was having involuntary twitching and her limb heaviness was worse. Strength 3/5 to BUE and BLE at that time. She stated a medical history of anxiety/depression and tardive dyskinesia, NKA, no previous history of vaccine reactions. She states she had eaten breakfast that day but did not have lunch. Her blood glucose was 111. 911 was called to escort the patient to the ER for further evaluation. Vitals remained stable during the observation period, repeat BP 138/76, HR 80 and regular, pulse ox ranged from 89-93% on room air, she did state some heaviness with breathing. Respirations appeared even and non-labored. She remained oriented x4 but was drowsy. She was not able to sit up or move herself to the medic cart upon arrival. Her husband was notified and she was transported to the hospital.
50 2021-03-16 feeling hot Pt vaccinated 2/25/01. Aprox 60-90 minutes after vaccination, pt noted feeling hot and itchy, she lo... Read more
Pt vaccinated 2/25/01. Aprox 60-90 minutes after vaccination, pt noted feeling hot and itchy, she looked in the mirror and was red/blotchy all over. She took 25mg benadryl as she was driving home and took another 25mg benadryl 20-30 min later when she arrived home. She continued to feel hot and itchy so took benadryl for the next 48 hours before those symptoms resolved. On day 4 after vaccine (2/29/01) pt began to notice redness in her right eye. The eye became more "bloodshot" as the day progressed and started feeling painful and "pressure" sensation. She went to see ophthalmologist urgently who diagnosed it as acute scleritis. She is currently on NSAIDs and topical steroid. She notes that the eye is very photosensitive and has significant "pressure" sensation. She is still experiencing these symptoms almost 3 weeks later.
50 2021-03-16 pain in extremity joint pains, right toe, left foot, bilateral knees, right elbow
50 2021-03-16 tingling Severe dizziness 1 hour after immunization, cleared after 1/2 hour. Starting day after vaccination,... Read more
Severe dizziness 1 hour after immunization, cleared after 1/2 hour. Starting day after vaccination, awoke with dizziness, nausea, chills. Diarrhea later in day. Starting 3 days after vaccine, painful and swollen and hard supraclavicular, Left axilla, cervical lymph nodes. Dizziness and nausea persist. Fatigue requiring 12 hours sleep. Paresthesias (tingling, "pins and needles"), both lower extremities, from toe to knee, unremitting, worst on day 2 after vaccination.
50 2021-03-17 inability to speak Patient had COVID-19 vaccine and approximately 20 minutes later could not seem to talk. She was not... Read more
Patient had COVID-19 vaccine and approximately 20 minutes later could not seem to talk. She was not reactive by speech while on site at facility and blood pressure was 170/110. She was not given an epi-pen but was sent to hospital by transport.
50 2021-03-17 flushing Patient waited the 15 minutes post vaccine and felt fine. After 40 minutes patient returned to the p... Read more
Patient waited the 15 minutes post vaccine and felt fine. After 40 minutes patient returned to the pharmacy light headed, flushed, and claimed mouth, lips and tongue were tingling. No signs of facial swelling. Nurse practitioner attached to the pharmacy examined the patient before sending her home in her husband's care.
50 2021-03-17 pain in extremity, discomfort Tired. Dizziness. Light headed. Slight chills. Heaviness in my "core". Nausea. Loud, heavy heart. Ac... Read more
Tired. Dizziness. Light headed. Slight chills. Heaviness in my "core". Nausea. Loud, heavy heart. Achiness in my legs. Ringing in both ears. Took 800 mg ibuprofen 3.12.2021 @ 12:30am. All symptoms resolved by 2:00pm on 3.12.2021 with the exception of Ringing in my ears. that is ongoing.
50 2021-03-17 speech disorder, inability to speak I got the vaccine last Thursday, March 4, 2021 and I am experiencing strange side effects. I wanted ... Read more
I got the vaccine last Thursday, March 4, 2021 and I am experiencing strange side effects. I wanted to be sure to send this along to you as well as, to the adverse effect website. It?s almost as if I?ve had a stroke. Initially (after the shot), I was a little lightheaded but as the rest of the day wore on, (say around 6 hours later), I started to get foggy in my brain - like I had to remember to even breathe - and tightness in my chest like asthma. There was a high pitch scream in my ears and I was more or less, kind of out of it. My hands and feet were sweating profusely. My tongue kind of reacted, too and got a little burned, like when I eat pineapple. It was then that I noticed difficulty swallowing. My sister (a medical professional) suggested Benadryl for the mouth and tongue sensation and she kept an eye on me the rest of the night. She also warned that I should not get a second shot (I totally agree). Being a trooper, I thought all of the weird stuff would blow over in a day or two, so I decided to power on and not report my issues. Today is day 6 post vaccine and I can now see a pattern to the symptoms or episodes which are still present, on and off: 1. The ringing in my ears will intensify, and then I stare off into space, my words get garbled (I have to really concentrate on being present), my tongue gets very dry and then the swallowing issue returns (it?s like slow motion swallowing, so I bite my tongue to stay in the moment). 2. The tightness in my chest intensifies and my breathing gets shallow. I must focus and breath through it despite discomfort. Note, since the shot, I keep a Benydryl and my inhaler with me, although I haven?t used Benadryl since day 3. I used my inhaler yesterday, day 5 because of discomfort and that seemed to help, but using it triggered an ear ringing/screaming episode that came and went the rest of the day. 3. I also have nasal constriction throughout the day. The nasal passage just inflames and then relaxes. I also have phantom smells and my sense of taste got a little off on day 1, but recovered. ________________ March 18, 2021 Update Saturday, 3/13 went to the ER because the cognitive issues had advanced. I found myself staring off into space, losing my train of thought, and unable to speak. When I did speak I stammered or stuttered. They wanted to make sure I did not have a stroke or that I was not in the middle of one, so they did some tests. They also recommended that I go ahead and take the prednisone. After my ER visit the cognitive issues continued, but began to be not-so-frequent by Sunday afternoon. I felt like I was on the road to recovery and so delayed again, taking the prednisone. On Tuesday (3/16), I had what I would call an asthma attack. I was having very strong bronchial spasms that would not abate. I used my rescue inhaler to try to mitigate the symptoms, but that did not work. At the same time, the cognitive issues sort of returned and the big loud ringing and whooshing in my ears was really really noticeable. I am having a protracted allergic reaction to the vaccine. I am not normally allergic to things, but I have noticed new allergies since this all began. Certain food items seem to bother me now and push me into the lung seizing, raw tongue, neurological, ear ringing event.
50 2021-03-18 discomfort, hot flush Dose 1 was given at 9 am on Friday morning Feb 26, 2021. I was fine until mid afternoon the next da... Read more
Dose 1 was given at 9 am on Friday morning Feb 26, 2021. I was fine until mid afternoon the next day when I started experiencing a bad headache. The headache was severe from Saturday Feb 27, 2021 evening until Monday morning February 28, 2021. After that I was fatigued and very tired until Wednesday, March 3, 2021. Dose 2 was given this morning, March 19, 2021 at about 9:30 am. On the drive home at 10 am, I started feeling the heaviness again.. as if a large heavy blanket is draped over my shoulders. This feeling comes in waves and I often experience hot flashes with the heavy feeling. No headache yet (fingers crossed!)
50 2021-03-18 feeling cold 6 am awoke fatigued, by12 pm started to have slight fever. By 1:30 fever of 100.3 continued to drink... Read more
6 am awoke fatigued, by12 pm started to have slight fever. By 1:30 fever of 100.3 continued to drink water at least 40 oz by 12pm. Layed down at 1:00 pm took 250mg of Tylenol. Still felt fatigued, fever may have been higher i did not retake. Slight headache, chills, fever, slight congestion. I felt super cold. Slept for a couple of hours, Isolated my self in my bed room. By 6 pm I awoke to eat dinner in my room. I could taste my food but dont remember smelling it. Fever was coming down but I still felt fatigued. At arpund 10 pm ate a little cutie tangerine noticed that it smlled like pine. Slept until 8am Sunday awoke rested no fever slightly fatigued. No other symptoms. Rested all day.
50 2021-03-18 feeling hot Pfizer-BioNTech Covid-19 Vaccine EUA. Increased heart rate, severe headache, vomiting (due to naus... Read more
Pfizer-BioNTech Covid-19 Vaccine EUA. Increased heart rate, severe headache, vomiting (due to nausea from headache). Warm but did not take temperature.
50 2021-03-18 feeling hot About 6 hours after being vaccinated, right hand got hot and was itching between the fingers. Laste... Read more
About 6 hours after being vaccinated, right hand got hot and was itching between the fingers. Lasted about 10 minutes.
50 2021-03-18 feeling jittery extreme hyperness and jittery. Felt wired. Symptoms calmed down after about 7 hours, but still jitt... Read more
extreme hyperness and jittery. Felt wired. Symptoms calmed down after about 7 hours, but still jittery the next morning.
50 2021-03-18 muscle twitching muscle twitch in arm lasting for several minutes
50 2021-03-18 pain in extremity, involuntary muscle movements, facial pain Got vaccine around 10:00 a.m. About 30 minutes after shot, I suddenly felt very exhausted, but it pa... Read more
Got vaccine around 10:00 a.m. About 30 minutes after shot, I suddenly felt very exhausted, but it passed within another 30 minutes. A few hours later, pain in upper arm got pretty intense. Then around midnight, the pain in my upper arm had grown so severe that it was spreading into my shoulder and neck. By 2:00 a.m., I woke up in sever pain in my face, not able to open my mouth because my jaw hurt so much. I went back to sleepI was not able to open my mouth until I repeatedly coaxed it open, around 8:00 a.m. By 10:00 a.m., my eyes itched like crazy and were red. My jaw getting stuck shut and my eyes itching insanely are why I'm completing this form.
50 2021-03-18 pain in extremity Intermittent painful electrical impulse in left hip radiating down into left leg. Started mildly, i... Read more
Intermittent painful electrical impulse in left hip radiating down into left leg. Started mildly, increased in intensity with each episode, approximately 12 episodes in total. This began about 5 hours after receiving the vaccine and continued for about 36 hours. As of today, March 19, the adverse reaction has disappeared. I had Covid 19 in November 2020, but I did not experience this reaction. In addition to the adverse reaction after receiving the vaccine, I also experienced severe fatigue, a mild headache, chills, inability to control body temperature but no fever, inability to eat, incredible thirst, which have all disappeared.
50 2021-03-18 pain in extremity a welt the size of a ping pong ball developed below the injection site; entire arm in pain with vein... Read more
a welt the size of a ping pong ball developed below the injection site; entire arm in pain with veins swelling; entire arm in pain with veins swelling; This is a spontaneous report from a contactable nurse, the patient. A 50-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration, administered in the left arm on 12Feb2021 at 15:00 (at the age of 50 years-old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient has no allergies to medication, food or other products. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2, via an unspecified route of administration, administered in the left arm on 22Jan2021 at 16:00 (at the age of 50 years old) for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 00:00 (reported as 12:00 AM), two days after the second dose (as reported), the patient experienced entire arm in pain with veins swelling, and on 14Feb2021 (exact time unknown), day 3 after the second dose, a welt the size of a ping pong ball developed below the injection site. The patient reported the events as non-serious. Therapeutic measures were taken as a result of entire arm in pain with veins swelling and a welt the size of a ping pong ball developed below the injection site included unspecified home pain medications and creams. The outcome of the events entire arm in pain with veins swelling and a welt the size of a ping pong ball developed below the injection site was recovering. It was also reported that since the vaccination the patient has not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
50 2021-03-18 tenderness Muscle pain, severe. Large muscle groups, legs and arms only. Also tender to touch.
50 2021-03-19 muscle twitching, tremor Slight headache beginning evening of vaccination. Progressed to fever <100.2, body aches, extreme t... Read more
Slight headache beginning evening of vaccination. Progressed to fever <100.2, body aches, extreme trembling, chills and twitching, blistering of the skin on the forearm of the same injection arm, delirium and hallucinations, wet cough with blood in sputum. Patient called pharmacy on Saturday 3/20/21 03:45pm to advise of reaction, RPh advised patient to go to a physician ASAP for evaluation of symptoms.
50 2021-03-19 tingling, weakness Doctor and EMT on site and provided care. Vasovegal syncope. Symptoms presented within 5 minutes of... Read more
Doctor and EMT on site and provided care. Vasovegal syncope. Symptoms presented within 5 minutes of vaccine given. Tingling started in Left arm tingling own to fingers and traveled to right arm and down through both legs. Rapid heart rate and disorientation prior to fainting. Sternum rub given to revive. Patient vomited. Able to drive home after 30-45 minutes. Continues to feel week and dizzy. Currently 24 hours after incident. Pain in arm preventing me from normal daily activities.
50 2021-03-20 weakness Chills, body aches, head congestion, headache, low grade fever (100.5) at its highest. Started at ab... Read more
Chills, body aches, head congestion, headache, low grade fever (100.5) at its highest. Started at about 7 am on 3/20 and lasted to 7 :30 a.m. the next day. Still feel a little tired and weak with very mild headache.
50 2021-03-20 pain in extremity, weakness Started at 1 am. from 1st vaccination. Sever headache , vomiting, chills, body aches, fever from 101... Read more
Started at 1 am. from 1st vaccination. Sever headache , vomiting, chills, body aches, fever from 101 to 102.7, nausea, few times I thought I was going to pass out, weakness., arm extremely sore As of 3/21/21 still weak, have a headache (not as intense) fever runs 99 to 101, arm still sore with a knot and is hot
50 2021-03-21 weakness Sudden onset of weakness and extreme light headedness. Avoided fainting by putting head between legs... Read more
Sudden onset of weakness and extreme light headedness. Avoided fainting by putting head between legs. Became very weak. Had to leave the appointment I was at and go home. Became very fatigued and temperature went up to 99.5. All symptoms came out of nowhere. There was no feeling bad or strange before onset.
50 2021-03-21 weakness Choking; Weakness; Sore throat; I kept waking up from it; This is a spontaneous report from a contac... Read more
Choking; Weakness; Sore throat; I kept waking up from it; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6199), via an unspecified route of administration on 05Mar2021 15:15 in right arm as single dose for covid-19 immunisation. The patient medical history was not reported. Known allergies was no. The patient had no other vaccine in four weeks. Concomitant medications included fluticasone propionate (FLONASE); vitamin d; cyanocobalamin (VITAMIN B12). On 05Mar2021 16:00, the patient experienced weakness after vaccination, sore throat last night and today, choking when sleeping, she kept waking up from it. No treatment was received for the events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Outcome of events were not recovered.
50 2021-03-21 migraine, pain in extremity Presented to ED on 3/10/21 for migraine and discharged home. Reported only sore arm following vaccin... Read more
Presented to ED on 3/10/21 for migraine and discharged home. Reported only sore arm following vaccination. Presented to ED on 3/7/21 with back pain, no COVID symptoms reported and was discharged home. Presented to ED on 3/10/21 with generalized body aches, nausea, vomiting, and headache for 2 days. Noted mild cough and sinus congestion and was admitted to hospital for 5 days until 3/14/21. Returned to ED on 3/15/21 with worsening shortness of breath and was admitted to hospital for another 5 days until 3/19/21.
50 2021-03-21 pain in extremity My arm has been aching since the 1st one. I let the RN giving me the 2nd shot aware and he said that... Read more
My arm has been aching since the 1st one. I let the RN giving me the 2nd shot aware and he said that?s weird. I just happened to have the same person injecting both times. Never reported or had me speak with anyone at that time. He said I could get it in the left, but I denied due to I didn?t want the pain in both arms. When he gave me the 2nd shot I felt it so much more than the first shot that I blurted out that hurts and a felt a twinge in my arm, as if it hit something other than the muscle. My arm 2 mos later is not let up the pain. I can only raise it so high. I cannot sleep on either side w/o pain. Same days are worse than others. The pain is right at the injection site. This is the only thing I have had done to my arm so I know it has something to do with the vaccine. I alternate ice and heat along with ibuprofen and it does not touch the pain/aches. It is a constant ache in my arm. I did contact my employee health at work and she advised me to fill out report on this website and in the Hospital safety report.
50 2021-03-21 tingling, tremor, numbness Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and need... Read more
Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and needles sensation all over my body; Hearing noises in my ears like a throbbing when I stand up; Barely walk to the bathroom; Chills; Everything sore; Sore throat; Began violently shaking around midnight; Fever was 103/Ran fever of 100.5-103 until this morning/Fever is below 100 today; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation at a Public Health Clinic/Administration facility. Medical history included Hashimotos. The patient has no Covid prior to vaccination and not tested for Covid post vaccination. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), lisdexamfetamine mesilate (VYVANSE), venlafaxine, cyanocobalamin (B12 [CYANOCOBALAMIN]), and ergocalciferol (VIT D). The patient had no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9269) on 09Feb2021 17:30 in the left arm for Covid-19 immunization. On 03Mar2021, sore throat began around 17:30 and chills began at 21:30. Patient took Tylenol and went to sleep. Violently shaking began around midnight (Mar2021); the patient was unable to get warm, yet fever was 103 (Mar2021). It was reported that everything sore on 03Mar2021 17:50. The patient ran fever of 100.5-103 until this morning (04Mar2021). Temp now fluctuates from 95-100. Mostly all "ept" until this morning (06Mar2021) waking to drink water and take Tylenol every 4 hours. The patient was still sweating profusely and was feeling delirious and dizzy (06Mar2021). Left arm is numb and has a pins and needles sensation all over her body on 06Mar2021. It was very uncomfortable. The patient was also hearing noises in her ears like a throbbing when she stands up. Fever is below 100 today (unspecified date), after taking a shower this morning, it was 95. The patient can barely walk to the bathroom on 06Mar2021 and she hasn't left her room since this started Wednesday night. Her husband called her doctor and she say this should pass by 9:30 tonight. There were times she prayed to die; she hurts so bad. Fortunately, the pain is not this bad now. But she was suffering greatly from the 2nd shot. The events sore throat and chills were treated, while the other events were not. The outcome of the events was not recovered.
50 2021-03-22 cold sweat 4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, ... Read more
4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, felt very "clammy", and had general ague upon any type of exertion such as walking a very short distance using my rolling walker device. This happened 3 times in approximately 2 hours on the day of vaccination. The next day (03/05/21) my blood pressure and heart rate were very elevated (BP 174/111, Heart Rate 168); I went to the emergency room where they were unable to lower my heart rate but sent me home anyway. 03/7/21 I went to ER, where I was diagnosed with atrial flutter and admitted. The atrial flutter was corrected via cardioversion and I was released 3/9/21; I was prescribed Multaq 400mg, 2X/day and take it faithfully.
50 2021-03-22 slurring Patient felt fatigued, tongue felt heavy. When bringing patient to UC felt heart beating fast. After... Read more
Patient felt fatigued, tongue felt heavy. When bringing patient to UC felt heart beating fast. After bringing patient to UC patient felt itching of tongue, feeling like throat is swelling, shortness of breath, dizziness, slurred speech, loss of consciousness, and chest heaviness.
50 2021-03-22 flushing Facial flushing, trouble swallowing, metallic taste, lip tingling
50 2021-03-22 nerve pain On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morn... Read more
On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morning (18th), I had a small Shingles lesion along with those symptoms. . I went to the doctor's office and saw the NP, who diagnosed me with an ear infection--right Otis externa. On Wed (19th) my right eye was swollen and my scalp, right forehead and eye were covered in shingles. On the 20th, I was diagnosed with having Ocular Shingles. I was put on steroids and sent to an emergent appointment with ophthalmologist because they were concerned that I would lose my sight. He put me on Acyclovir 800mg, 5 times a day and increased my steroids to: 40mg a day for 2 days, 30mg for 3 days and 20mg for 3 days and 10mg for 4 days. Fortunately the branch that goes into my cornea was not affected. I was in bed the entire time. I still had lesions when I went back to see him, which is why he kept me off work until Feb 1st. I continued to have neuralgia (nerve pain) and then I started itching. I went back to quick care and put on Atarax. I took that every 4 hours for about a week. Then I tapered it down to about twice a day. It eventually got better, but I do itch sometimes. Looking back, I did have a little right ear pain after the 1st dose of the vaccine.
50 2021-03-22 pain in extremity Symptoms day of and next day: sore arm only Day 3, 6am- 12 noon: Nausea, vomiting, fever, severe h... Read more
Symptoms day of and next day: sore arm only Day 3, 6am- 12 noon: Nausea, vomiting, fever, severe headache, body aches, excessively tired.
50 2021-03-22 pain in extremity Severe left arm pain, ice pack applied. Five minutes later dizziness occured, BP 79/50. BP raised to... Read more
Severe left arm pain, ice pack applied. Five minutes later dizziness occured, BP 79/50. BP raised to 116/79 over next three minutes with giving juice.
50 2021-03-22 tenderness left ring finder tender on Monday 03/22/21, Woke up Tuesday, 03/23/21 finger swollen, as the day ha... Read more
left ring finder tender on Monday 03/22/21, Woke up Tuesday, 03/23/21 finger swollen, as the day has gone on it has gotten redder Called and spoke with a Teladoc doctor, said to take ibuprofen and ice, watch for 24/48 hours if gets redder or hot go and have it checked out for possible infection
50 2021-03-22 tremor Approximately 10 minutes after patient received vaccine, she became shaky and lightheaded. BP 125/80... Read more
Approximately 10 minutes after patient received vaccine, she became shaky and lightheaded. BP 125/80, pulse 100, pulse ox 95%. Respirations unlabored at 18/min. Patient was talkative and oriented. She did request further evaluation at the ER. She requested transport to the ER and EMS was called. Patient ambulated to the squad per medic.
50 2021-03-23 breast pain, pain in extremity Arm and breast pain on the side the vaccine was given. Chills for about 3 hours, extreme pain in the... Read more
Arm and breast pain on the side the vaccine was given. Chills for about 3 hours, extreme pain in the whole body, headache, tiredness.
50 2021-03-23 feeling hot, tremor, feeling jittery Vaccine given IM about 9:30am to right deltoid muscle. Patient monitored for 15 minutes, felt okay ... Read more
Vaccine given IM about 9:30am to right deltoid muscle. Patient monitored for 15 minutes, felt okay and left monitoring area. Patient returned after about 20 minutes from vaccine (a little after 9:50am) complaining of itching of throat, shortness of breathe, and feeling very hot and "off" Due to SOB and itching in throat administered 1 dose of Epinephrine autoinjector 0.3mg shortly upon her return, called EMS. EMS arrived and evaluated patient, patient refused transport to hospital since she was feeling better except for jitters/shaking from epinephrine. We monitored patient for additional 20-30 minutes. Patient walked around store, felt fine and drove home. Called patient, verified still feeling mostly better with some slight itchy throat. Patient will continue to monitor.
50 2021-03-23 flushing, feeling hot diagnosed acute right eye scleritis; Rash on face, neck, chest, arms, hands; flushed in the face; it... Read more
diagnosed acute right eye scleritis; Rash on face, neck, chest, arms, hands; flushed in the face; itchy all over the body; hot all over within 45 minutes of the shot administration; This is a spontaneous report from a contactable consumer reported for herself. A 50-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 25Feb2021 13:00 (Lot Number: EL9266, at age of 50-year-old) at single dose for covid-19 immunization. The COVID-19 vaccine was administered at facility of workplace clinic. Medical history included hashimotos thyroiditis, allergies to sulfa, penicillin, latex. The patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication with in 2 weeks of vaccination included thyroid (THYROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021 at 13:45, the patient experienced rash on face, neck, chest, arms, hands, flushed in the face, itchy all over the body, hot all over within 45 minutes of the shot administration. Diphenhydramine hydrochloride (BENADRYL) was required for 36 hours to mitigate the reaction. Then on 01Mar2021, right eye developed increased pressure, pain, inflamed blood vessels, severe photosensitivity. At emergent eye doctor appointment, the patient was diagnosed acute right eye scleritis. Treatment for the events included diphenhydramine hydrochloride, steroid eye drop, antiinflammation meds. The events were non-serious per reporter. The events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.
50 2021-03-23 pain in extremity Swelling in left axilla, pain in lower arm.
50 2021-03-23 pain in extremity Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pai... Read more
Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pain, and a welt on my tongue. Blood sugar high in 300s The next day tongue was a bit better other symptoms the same and heart felt fluttery, and my left breast and center between felt like bruises and small lumps. Headache finally gone by Tuesday and sugars in high 200s but the rest is about the same. Less tired though
50 2021-03-23 pain in extremity Very sore arm, muscle aches, fatigue, slight off and on headache, dry eyes, slight nausea, tickle in... Read more
Very sore arm, muscle aches, fatigue, slight off and on headache, dry eyes, slight nausea, tickle in throat with light coughing.
50 2021-03-23 tingling Tingles in hand, aches. Assessed RMA . no transport
50 2021-03-24 weakness, feeling jittery Chills, fever, dizziness, weakness, jittery, can?t sleep, fatigue, swollen, thirsty. Received shot ... Read more
Chills, fever, dizziness, weakness, jittery, can?t sleep, fatigue, swollen, thirsty. Received shot at 8:48am, symptoms began at 12:30pm while on a bike ride. I finished the ride but was too weak to do anything the rest of the day. That night I couldn?t stop shaking and lay in bed wide awake until about 2am. I felt dizzy like I was spinning when I closed my eyes. I slept off and on until 6:30am. Today I?m feeling slightly better but still can?t sleep. I am drinking an excessive amount of water and herbal tea.
50 2021-03-24 feeling cold evening around 4p.m. after the vaccine Adverse effect- lethargy, sleepy 03/23/21 felt cold, swollen... Read more
evening around 4p.m. after the vaccine Adverse effect- lethargy, sleepy 03/23/21 felt cold, swollen lip and face, lethargy, sleepy Ever have a reaction to a previous vaccine? If yes, what? no- usually gets 3 vaccines each month for allergies she didnt take the third dose this month because she was getting the COVID vaccine, area of injection usually gets swollen when she gets these vaccines and it goes away within a few hours Recommendations: please contact your PCP for recommendations since he has your medical records available, see what he recommends for you to take whether it be your prescribed allergy medication or any OTC items. If you are currently experiencing any Shortness of breath please visit your nearest Emergency Department, otherwise inform your PCP that you are experiencing swelling on your lips and that you experienced a swollen face that subsided. Consult with him on whether you should or shouldn't get the second dose vaccine, one of the contraindications for the vaccine is anaphylaxis so its better to take precaution.
50 2021-03-24 muscle spasms Starting either the night of the vaccine or the next I had a horrible time sleeping. Up and down, ba... Read more
Starting either the night of the vaccine or the next I had a horrible time sleeping. Up and down, back and forth. Then I developed terrible pain in my neck all over. I tried OTC meds that did not alleviate the pain in addition to heating pad, stretching, neck constriction with neck brace. This lasted about a week with the pain mostly in the two front muscles in the neck. I had a day or two of respite but the pain came back as what feels like muscle spasms in my upper left and right shoulder/neck area. Difficulty turning head. Headache.
50 2021-03-24 numbness and pain in extremities, pain in extremity Very tired; A little upset stomach; Neuropathy returned in my hands, feet and lower legs; Neuropathy... Read more
Very tired; A little upset stomach; Neuropathy returned in my hands, feet and lower legs; Neuropathy returned in my hands, feet and lower legs; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (BNT162B2, Lot number: EN6199; Expiration date was not reported) on the left arm on 04Mar2021 (16:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the public health clinic. Medical history included rectal cancer from 2018 to an unspecified date; chemo from 2019 to an unspecified date; and neuropathy that was left from the chemotherapy. The patient had unspecified concomitant medications. The patient previously took aspirin (acetylsalicylic acid), and had drug allergy. The patient was not pregnant at the time of vaccination. On 04Mar2021 (17:30), the patient's neuropathy had returned in the hands, feet and lower legs; and had sore arm. On 05Mar2021 (10:30), the patient was very tired, and had a little upset stomach. The patient did not receive treatment for the events. The outcome of the events, 'neuropathy had returned in the hands, feet and lower legs', 'sore arm', 'very tired' and 'little upset stomach', was recovering. The patient has not had COVID-19 prior to vaccination; and was not tested for COVID-19 post-vaccination.
50 2021-03-24 pain in extremity The next evening after the day of the vaccine I experienced dizziness, I felt like I was going to fa... Read more
The next evening after the day of the vaccine I experienced dizziness, I felt like I was going to fall over but never did, it was pretty unnerving and scary, my doctor suggested me to take Extra strength Tylenol and that did not help with anything. I also tried Claritin as well it did not help either. The dizziness lasted 4-5 weeks. I also had a sore arm.
50 2021-03-24 pain in extremity the evening of the injection, patient noted arm pain radiating from shoulder to hand.
50 2021-03-24 pain in extremity After two days of fever and headache , I had some painful lumps on left underarm toward my left bre... Read more
After two days of fever and headache , I had some painful lumps on left underarm toward my left breast for three days. They disappeared for a couple of days and back again from yesterday. Its kind of burning in lumps with mild pain left side, arm, neck and back shoulder.
50 2021-03-24 tingling, burning sensation, feeling cold 11am - jaw felt odd, tingling on left side 1pm - rt side of lower back of head felt like ice, tingli... Read more
11am - jaw felt odd, tingling on left side 1pm - rt side of lower back of head felt like ice, tingling on rt side of head over next few hours ( I wouldn't call this a headache) 4pm- roof of mouth burning 10pm - went to sleep but only one side of head felt like fire/ice along with mouth 7am - upper body and head feels like on fire/ice Never had a fever
50 2021-03-24 tingling Pt developed left sided facial tingling shortly after receiving her vaccination. She noted some very... Read more
Pt developed left sided facial tingling shortly after receiving her vaccination. She noted some very mild difficulty swallowing.. Her symptoms resolved after several minutes. She denied any other associated symptoms. No objective mouth/throat swelling appreciated. HR 46 which pt states is normal for her, BP 110/80, SP02 99%. EMS services were offered but pt declined and drove home.
50 2021-03-24 seizure While I was asleep my partner saw me having what looked like a seizure on Tuesday 03/23/2021 @11:30p... Read more
While I was asleep my partner saw me having what looked like a seizure on Tuesday 03/23/2021 @11:30pm. I was sleeping on my stomach, my partner describes it like a fish flopping.
50 2021-03-25 weakness, pain in extremity, hot flush I began with some throat closing and pain in arm. It progressed to body aches, feeling winded and fa... Read more
I began with some throat closing and pain in arm. It progressed to body aches, feeling winded and fatigue, weak, sneezing, congestion, dripping nose, hot flashes and joint pain. I went to bed and had insomnia the whole night. Had rapid heartbeat and trouble breathing. I called doc next day and they recommended o go to hospital.
50 2021-03-25 coordination abnormal, muscle spasms Confusion, dizziness, loss of coordination, excruciating body pain, nauseous,diarrhea, headache, vo... Read more
Confusion, dizziness, loss of coordination, excruciating body pain, nauseous,diarrhea, headache, vomiting Within 48 hours of both vaccines menstrual cycle began with severe cramping , heavy bleeding and 2 weeks early
50 2021-03-25 numbness Patient received her 1st Pfizer vaccine on 3/21/21 around 2:30. She states she started to feel numbn... Read more
Patient received her 1st Pfizer vaccine on 3/21/21 around 2:30. She states she started to feel numbness over her face and some slight difficulty swallowing within minutes after receiving her vaccine. She sat in the observation area for 15 minutes but never reported her symptoms to the staff. She also states that she started to feel anxious as well and wasn't sure if it contributed to her symptoms. She said she felt like she just needed to get some fresh air. When she got home she took Zyrtec 10mg and had relief of her throat symptoms and some improvement of the numbness over her face. She did not have complete numbness until 3/25/21. She notified her physician of this event and he advised her to return to the clinic and report it.
50 2021-03-25 muscle spasms muscle spasms in neck and back , self treated after calling doctor. was told to take 200mg of benadr... Read more
muscle spasms in neck and back , self treated after calling doctor. was told to take 200mg of benadryl and 80mg of pepcid, and 800mg of ibuprofen.
50 2021-03-25 tingling Client c/o tingling sensation to the right hand and arm. Client seen and assessed by EMt and V.S. a... Read more
Client c/o tingling sensation to the right hand and arm. Client seen and assessed by EMt and V.S. are BP 153/93, HR 81, O2 97. Within 15 minutes of observation client verbalized that she started to feel a decrease in sensation. Client then cleared to go home by EMT. Client advised to seek medical attention if symptoms worsen.
50 2021-03-25 throat numbness, hot flush Patient received COVID vaccine at 1048 a.m. Initially reported "throat numbness to medical assistant... Read more
Patient received COVID vaccine at 1048 a.m. Initially reported "throat numbness to medical assistant after 15 minutes of observation. At 1126 patient reports "hot flashes and knot to throat. Epinephrine 0.3 mg administered to left thigh. EMS called and patient transferred to hospital ER per patient request.
50 2021-03-26 numbness Pt developed numbness in R arm, radiating to hand progressing to L arm, face and tongue. Medical con... Read more
Pt developed numbness in R arm, radiating to hand progressing to L arm, face and tongue. Medical consultation recommended transport BP 104/80, HR 60, SpO2 100%, RR 12 EMT arrived 10:45am, pt transported.
50 2021-03-26 tremor Patient stated that approximately 5 minutes after receiving Pfizer COVID-19 vaccine (1st dose), she ... Read more
Patient stated that approximately 5 minutes after receiving Pfizer COVID-19 vaccine (1st dose), she began to feel nauseous and notified RN gave patient a bottled water. RN assessed patient and notified EMS on scene. During assessment, patient admitted allergies to bee stings (was previously prescribed an Epi-Pen, but has "not had one in a while"). Patient also admitted having recent allergic reaction to seafood 2 months ago that caused lightheadedness and nausea; patient was seen at Hospital for this reaction. Patient also stated an allergy to aspirin that causes "flu-like symptoms." During this assessment, patient appeared to be alert and oriented x 3 with no signs of respiratory distress. During assessment, patient developed red patches on the posterior and bilateral neck, along with red hives (approximately 1/2 inch in size). Patient complained of feeling lightheaded and nauseous. Hands were trembling. Patients vitals were within normal limits, although blood pressure was slightly elevated.
50 2021-03-27 weakness Chills weakness muscle pain muscle weakness body aches. sweating
50 2021-03-27 feeling hot, tremor, feeling cold Around 1130 pm started shaking and very cold, then I started sweating, and with in an hour I was so ... Read more
Around 1130 pm started shaking and very cold, then I started sweating, and with in an hour I was so on fire I was laying in bed with cold rags on to stay cool. I was in front of 2 fans and could not get cooled off. Barley slept that night. According to thermometer my temp was only 98.9 but I was very very hot. Stayed that way until about 10 am. All day I felt very tired but ok, then around 6 pm I was on fire again and exhausted. I went to bed around 730 pm and slept till around 9am. When I woke up several times and checked my temp it was fine 98.9 and 98.8, however I felt like it was more like 110, I can not explain how on fire my whole body was. Sunday I feel back to normal besides being a little warm today. I have had hives Friday and today but I keep getting them and I am pretty sure it is part of my idiopathic hives problem.
50 2021-03-27 pain in extremity Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my bod... Read more
Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my body 1-2 days All of my body ached 1-2 days Headache for a day or two (not extreme) Scratchy throat off and on for a few days Nauseous/ nothing sounded good to eat 3-5 days Upset stomach and rolling stomach with borderline diarrhea about 3 days Itchy all over (no rash at all) for a solid two weeks and now just occasionally Left hand and joints swelled slightly 2 weeks+ Tightness in chest 2 days and periodically for 2 days more
50 2021-03-27 pain in extremity For the first 24-48 hrs I was fatigued, had a very sore arm and experiences a metallic taste, smell.... Read more
For the first 24-48 hrs I was fatigued, had a very sore arm and experiences a metallic taste, smell. After two days I got a canker sore. 7 days later my resting heart rate is 158-163. prior to the shot my resting heart rate was 168.
50 2021-03-28 slurring Systemic: swollen tongue/slurred speach-Medium
50 2021-03-28 feeling cold On Mar 26 I was achy and frigid. On Mar 27 I have poke up to a red rash on chest, face and neck, swo... Read more
On Mar 26 I was achy and frigid. On Mar 27 I have poke up to a red rash on chest, face and neck, swollen lymph nodes in throat, sore throat, and very large swollen lymph node in left arm pit. This lasted thru Sunday Mar 28. On Mar 29 I woke up to severe, frequent watery diarrhea and stomach gurgling along with burping and general gastro discomfort.
50 2021-03-28 feeling hot, throat numbness, flushing Metal taste in mouth and throat numbness post vaccination Vital Signs: B/P: 138/86 HR: 82 then 104 ... Read more
Metal taste in mouth and throat numbness post vaccination Vital Signs: B/P: 138/86 HR: 82 then 104 due to dark nail polish O2Sat: 91 then 98 due to dark nail polish c/o HA with 1st shot x 1 day C/O being overheated , Face flushed Circulation: Unable to assess due to dark nail polish Resp.: Breath sounds clear bilaterally Treatment: Assessed then observed by RN until symptoms subsided Reassessment: 13:41 Vitals: B/P:118/86 HR: 80 Resp.: 12 O2Sat: 97 Notes: Patient drove self to clinic. D/C from triage on own accord @ 13:45. Steady gait. Denies dizziness. Conversing appropriately.
50 2021-03-28 flushing About 10 minutes after receiving Pfizer Covid-19 vaccine, patient started feeling throat tightness. ... Read more
About 10 minutes after receiving Pfizer Covid-19 vaccine, patient started feeling throat tightness. As she was being assessed by medical staff, her face began to itch. She had visible flushing, and facial/lip swelling. Epipen was used and squad called to transport to the local ED. The hospital gave her steroids and antihistamine treatment and kept her several hours for observation. On 3/29/2021, patient reports she has been fine since release from the hospital, other than typical vaccine side effects (achiness, arm soreness).
50 2021-03-28 hot flush, pain in extremity, tingling shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in... Read more
shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm; shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm; got extreme pain all the way down to the tips of my fingers; slight tingling in the fingertips; could not move my arm; nausea; dizziness; bone pain in arms and legs; exhaustion; My arm still hurts; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 50-years-old, administered in Arm Right on 05Mar2021 11:00 (Lot Number: EN6205) as single dose for COVID-19 immunization. Medical history included allergies to walnuts. The patient was not pregnant. The patient's concomitant medication included High blood pressure medication. The patient previously took Niacin and experienced allergies. The patient reported, "shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm, starting at the top of my shoulder down to my hand and got extreme pain all the way down to the tips of my fingers with slight tingling in the fingertips. I could not move my arm, blood pressure shot up to 200 then it was 192/121 and so on I was monitored at the hospital for a couple of hours with no change or help. I went home and monitored for 29 hours it stayed elevated in the upper hundreds, spiking lowering down a few to 174/124 and spiking back up I got the vaccine on Friday at 11:00 AM my blood pressure did not break until Saturday around 3:00 p.m. I got other side effects, nausea, dizziness, bone pain in arms and legs, exhaustion but the blood pressure scared me the most. My arm still hurts to this day 12Mar2021. I was evaluated but not given anything to bring it down." The adverse events started on 05Mar2021 11:00 AM. The events resulted in Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization). No treatment for adverse events were received. The patient underwent lab tests and procedures which included blood pressure measurement: high, up to 200 then it was 192/121 on 05Mar2021 spiking lowering down a few to 174/124 on Mar2021. The patient recovered with lasting effects. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
50 2021-03-28 numbness, tingling "Pfizer-BioNTech COVID-19 Vaccine EUA" Numbing/Tingling sensation on left side of body (i.e., left s... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" Numbing/Tingling sensation on left side of body (i.e., left side of face to corner of mouth, down arm to fingertips and left leg)
50 2021-03-28 tingling c/o tingling sensation going down front of face, down front of body. EMS present
50 2021-03-28 speech disorder Vaccine was given during a drive through event. During the 15 minute waiting period the patient was... Read more
Vaccine was given during a drive through event. During the 15 minute waiting period the patient was talking with her caregiver and then stopped talking and was not able to respond to caregiver . Seemed to be trying to talk but unable to respond to questions. She was assessed and blood pressure was 170/110. She was sent by EMS to the local emergency room where she was further evaluated. She returned to baseline and was released same day.
50 2021-03-29 flushing, cold sweat, feeling hot Patient received COVID Pfizer vaccine at approximately 0955 and reported back to unit. Medical was c... Read more
Patient received COVID Pfizer vaccine at approximately 0955 and reported back to unit. Medical was called to unit at approximately 1030. Upon arrival to unit patient was laying down on floor and stated she felt hot and achy all over. Patient's vitals in unit: bp 156/126, hr 135, R 22, 02 sat 98% on room air. Patient has strong history of anxiety. Patient brought to medical for further evaluation: Face/chest flushed, hyperventilation, tachycardia, skin diaphoresis/clammy. No skin hives. No wheezing. No vomiting/diarrhea No swelling lips/face. 02 @ 2 L given, blood sugar 126, last bp 129/77-hr 109 EPIPEN given via R thigh, EKG shows sinus tachycardia, possible inferior infarct, Abnormal ECG. Will send pt to local ED. *Report from ED received: indeterminate troponin and elevated WBC count, also with elevated BUN and creatinine. Pt will likely be held overnight for observation for suspected cardiac issues. Vaccine reaction not suspected at this time.
50 2021-03-29 flushing SP02 99% heart rate 102 Feeling flushed and warm b/p 128/90 Hx of asthma, no shortness of breath... Read more
SP02 99% heart rate 102 Feeling flushed and warm b/p 128/90 Hx of asthma, no shortness of breath. 4:20 pm still feels flushed, no shortness of breath. Only allergy is Keflex, no dizziness. Offered to go the the ER but, declined. Told to monitor and call 911 if worsens. Daughter is with her.
50 2021-03-29 hot flush, feeling hot client reported being hot b/p 120/84 SP02 100% pulse 68 Has hot flashes, monitored then walked to th... Read more
client reported being hot b/p 120/84 SP02 100% pulse 68 Has hot flashes, monitored then walked to the door with staff and husband. Reported feeling fine except still warm. Steady gate.
50 2021-03-29 numbness, weakness After receiving the shot in L arm... immediately 1. dizzy and lighthead 2. tingling/numbness in L fi... Read more
After receiving the shot in L arm... immediately 1. dizzy and lighthead 2. tingling/numbness in L fingertips within 30 min 1. numbness on L side of face 2. MD assess weakness on L UE Next day...continue to feel numbness on L side of face
50 2021-03-29 numbness, tingling Received shot at 4:15pm got in car after waiting 20 minutes at site.my. left arm was starting to get... Read more
Received shot at 4:15pm got in car after waiting 20 minutes at site.my. left arm was starting to get numb and tingly as i drove home at home my face felt numb and tingly. Called 23 hour nurse told me to call 911 my left leg was numb and tingly and weak my left side of my brain was numb and tingly.
50 2021-03-29 numbness Facial numbing, itchy ears and eyes for approximately two hours after the shot.
50 2021-03-29 muscle spasms, inability to speak It started with chills then my body got completely stiff and sore I had to get help to the bed when ... Read more
It started with chills then my body got completely stiff and sore I had to get help to the bed when I got in the bed I was there for four days during that. I had extreme body pain from the feet to the top of the head my eyes hurt I started sweating about three days in to the point where I mean my mattress was soaking wet my sweat smelled horrible I started having Hallucinations about two times seeing things that were not there my vision was very very cloudy and blurry I can hardly speak I have cramps in my feet on the fifth day I woke up yeah my body didn?t hurts I was no longer sweating but I had a headache. I also did not eat anything and could not eat anything for all those days it wasn?t until six days later that I was able to move around And feel somewhat back to normal my vision is still cloudy
50 2021-03-29 tingling, weakness Headache, chest pain as pins and needles, shortness of breath, swollen throat, tounge, limpthotic no... Read more
Headache, chest pain as pins and needles, shortness of breath, swollen throat, tounge, limpthotic nodes, difficulty to breath and to swallow, weakness, disoriented, pain in body, difficulty to urinate, dizziness, blurry vision, nausea, tachardia, pulse rate increase, blood pressure increase, fatigue, body and muscle pain.
50 2021-03-29 seizure, seizure like phenomena, tremor 3/29/2021 ERS Report: from Vaccination Clinic: Patient reported symptoms: Per ERS report: "Pt was ... Read more
3/29/2021 ERS Report: from Vaccination Clinic: Patient reported symptoms: Per ERS report: "Pt was walking to car after receiving her COVID-19 vaccine and a syncopal episode. Pt then had seizure like activity for approximately 1 min. Family states that she does have "stress seizures but is not on any anticonvulsants." Vital signs and blood sugar were assessed by onsite paramedic (AMR) and were within normal limits. Pt was then transported to hospital for further care." ED visit after Covid Vaccine 3/29/2021: HISTORY OF PRESENT ILLNESS: a 50 y.o. female who presents to the emergency department with history of bipolar and multiple psychiatric conditions including bipolar disorder. She presents today with episodes of ?seizure? and the desire to not speak to anybody. She has not been speaking to her husband since Friday and today while she was on the way out from getting a COVID vaccine fell to the floor and having shaking convulsing like episode. Husband states it lasted for 1 minutes and then resolved. He states that she has been unwilling to talk to him or medical staff and he does not know what is going on. He does affirm that she has been complaining about abdominal pain for the last 3 days and they did go to the hospital and have this worked up. He states that she has no known history of seizures and is not on any medications for this. CT head normal. Drug screen normal. Discharged to home.
50 2021-03-29 tremor Covid vaccine Pfizer ER8733 . Pt given vaccine and sent to seat. noted gait unsteady. pt seated and ... Read more
Covid vaccine Pfizer ER8733 . Pt given vaccine and sent to seat. noted gait unsteady. pt seated and noted staring gaze .bp 121/93 HR 100 and reg. pt started to list to side. Placed on litter and taken to er. pt had some shaking of extremities but was able to do some hand grasps on demand. placed in care of er staff. slow responses. husband with pt.
50 2021-03-30 weakness, feeling hot Received vaccine at 3 pm. Feeling fine until 1520, noted some chest tightness and shortness of breat... Read more
Received vaccine at 3 pm. Feeling fine until 1520, noted some chest tightness and shortness of breath. Denied trouble swallowing; sipping apple juice. Notes of late being tested for low blood sugar issues; no diabetes. HR 105, BP 118/74, p ox 98%. Additionally feeling hot. Transferred to wheelchair; feels weak, shaky. With chest tightness, called Rapid Response; patient agreeable to ED evaluation. Notes having to breathe a bit more deeply to help breathe. Transported to ED by Rapid Response team.
50 2021-03-30 weakness I could barely move; a lot of weakness; fell at home twice; This is a spontaneous report from a cont... Read more
I could barely move; a lot of weakness; fell at home twice; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the first dose of bnt162b2 (Batch/Lot Number: EM9809), via an unspecified route of administration, administered in the right arm on 10Mar2021 12:15 as a single dose for covid-19 immunization. The patient's medical history included multiple sclerosis known allergies (not specified) from an unknown date and unknown if ongoing. On 11Mar2021, the day after the vaccine patient had a lot of weakness and fell at home twice. No injury from falls. They were more guided drops to ground. Patient was seen in the emergency room (ER). The next morning 12Mar2021, patient could barely move from weakness. She went back to ER and was admitted for high dose IV steroids. Work up while in hospital lead the doctors to conclude it was from the vaccine. It was reported that the patient was hospitalized for 3 days. The patient was recovering from the events at the time of the report. The patient has not had Covid-19 prior to vaccination and was not tested for Covid-10 post vaccination.
50 2021-03-30 flushing, feeling jittery 1726-Vaccinated 1734-C/o dizziness, flushing, lightheadedness, sweating, palpitation, anxious/jitte... Read more
1726-Vaccinated 1734-C/o dizziness, flushing, lightheadedness, sweating, palpitation, anxious/jittery, sleepy, tingling-tongue. 1820 c/o chest tightening. Patient refused Epi. Benadryl 50 mg/IM given, Patient was transferred to ER.
50 2021-03-30 flushing Mild dizziness, metallic taste in mouth, flushing and urge to clear throat 13 minutes post 2nd dose ... Read more
Mild dizziness, metallic taste in mouth, flushing and urge to clear throat 13 minutes post 2nd dose vaccine. Symptoms resolved within 30 minutes and client left on own with steady gait.
50 2021-03-30 pain in extremity Severe pain on left side of torso and neck. Inability to turn neck to the left or lift left arm.
50 2021-03-30 pain in extremity Extreme fatigue, extreme arm pain, petechiae on Stomach
50 2021-03-30 pain in extremity Under my eyes swelled up on both eyes. My face was red....it felt sunburned. I had welts on my in... Read more
Under my eyes swelled up on both eyes. My face was red....it felt sunburned. I had welts on my inner tighs and private area. Normal symptoms were sore arm and ache body. Bad headache
50 2021-03-30 tremor Please note, 1st dose on Feb 11, 2021 - Sweating and stomach issues 4 hours after shot- EL9261. And... Read more
Please note, 1st dose on Feb 11, 2021 - Sweating and stomach issues 4 hours after shot- EL9261. And problems waking up gasping for air when first falling asleep at night. (I did not think that these were related to the vaccine, but did not have these symptoms before the shot. 14 minutes after the shot (2nd dose - on March 4), my heart started racing, hands started shaking and I could not swallow, my color was pale also. (Medical officer came and assisted.) It happened a total of 4 times over an 1.5 hour period. The medical officer said that I was having an Adrenalin response. I was given pepsid and claritin. (I had to take it for 4 days). After that I did not have any more episodes. The problems waking up gasping for air (since the first shot on 2/11) stopped after taking the pepsid and claritin also. I had no other symptoms.
50 2021-03-31 difficulty speaking Patient with onset of tickle in throat, cough, sweats, hoarse voice, and headache s/p 2nd dose COVID... Read more
Patient with onset of tickle in throat, cough, sweats, hoarse voice, and headache s/p 2nd dose COVID vaccine Brought to observation area for assessment, water bottle given Consulted with Dr - MD evaluated pt's throat, visualized with otoscope, and no swelling seen Able to talk with scratchy voice, feels better sipping water Episode of dry heaves with no emesis Cetirizine 10 mg PO given, pt able to tolerate after dry heaves resolved Monitored for 30 minutes post admin of Cetirizine with improvement of symptoms, pt reports tickle in throat and cough resolved, overall feeling better, no further dry heaves. Advised to go to ED if any symptoms return or any new symptoms, pt verbalized understanding
50 2021-03-31 fibromyalgia Body aches that have persisted for 3 weeks. Significant flare up of osteoarthritis and fibromyalgia... Read more
Body aches that have persisted for 3 weeks. Significant flare up of osteoarthritis and fibromyalgia. Significant fatigue that has persisted for 3 weeks.
50 2021-03-31 pain in extremity Headache- 48 hours Chills- 48 hours Fever- 12 hours Underarm pain (right side)- continuing- today is... Read more
Headache- 48 hours Chills- 48 hours Fever- 12 hours Underarm pain (right side)- continuing- today is day 5, I believe it is swollen lymph nodes. If not better I will go to Dr next week
50 2021-03-31 tingling, paralysis Completely unable to move my body and mouth for a couple of hours. Severe headache, severe tingling ... Read more
Completely unable to move my body and mouth for a couple of hours. Severe headache, severe tingling in my legs.
50 2021-03-31 tingling In order, chills, nausea, severe vomiting, chest pain, shortness of breath, tingling in hands, heada... Read more
In order, chills, nausea, severe vomiting, chest pain, shortness of breath, tingling in hands, headache, fever, swelling under armpit of same arm vaccine received.
50 2021-03-31 tingling About 5-7 seconds after the vaccine was administered, I started to feel a tingling sensation in my ... Read more
About 5-7 seconds after the vaccine was administered, I started to feel a tingling sensation in my lower legs, that moved up my legs, and was accompanied by a rapid heart beat. This subsided after 1 or 2 minutes. At the time, I assumed it was anxiety, and because I was sitting in my car, I turned my air conditioning on my face to cool down. Afterward, I told a man what happened, and he asked me how I was feeling at that point, and that he wanted me to stay there for an additional 5 minutes for observation. After researching, I feel it was an allergic reaction, not anxiety.
50 2021-03-31 tingling My face began to tingle (specifically the left cheek) and my lips began to swell (similar to "liver ... Read more
My face began to tingle (specifically the left cheek) and my lips began to swell (similar to "liver lip" when I take hydrochlorothiazide). This began 20 minutes after the injection. I contacted a nurse (?) who was said to wait and she would return to check on me. After 10 minutes no one came back and things did not get worse so I left. The lip swelling remained for a couple of hours. It looked like I had botox (bad botox) on my lips.
50 2021-04-01 weakness, tingling Left arm did not hurt and no symptoms until on day 9, left arm got mildly painful at injection site ... Read more
Left arm did not hurt and no symptoms until on day 9, left arm got mildly painful at injection site and tingling radiating to the fingertips. Feeling of weakness in the arm. Not constant but fairly frequent. Received 2nd dose on 4/1/21 (Pfizer ER8732) and arm is more painful and tingling and weakness have increased.
50 2021-04-01 pain in extremity, burning sensation ARM became sore around 5 pm. Pain continued down my arm. Then I began to itch on left arm then scal... Read more
ARM became sore around 5 pm. Pain continued down my arm. Then I began to itch on left arm then scalp, then neck & face real bad. Left Ear became real hot and last til bout 8 am. Body felt like i had a sunburn. I applied 2 ice packs from 9 to 10 pm on arm . Red around injection site and felt hot to the touch since 5pm yesterday. when I woke up I tried to call clinic, they were closed. I took generic benadryl and it has helped but started itching again around 7pm 4/2/21. So I am going to take another beadryl.
50 2021-04-01 pain in extremity, electric shock sensation, tingling At the time of the injection patient had immediate tingling and "electric" sensation. After 15 minut... Read more
At the time of the injection patient had immediate tingling and "electric" sensation. After 15 minutes, patient had reddness and soreness at the injection site. Left arm remained sore throughout the day. Patient ran 3 miles on a treadmill from 8:30-9:15. At 10:20 p.m. the upper arm became painful to touch and uncomfortable to use. The patient took 2, 200 mg ibuprophen for pain and went to bed. In the morning the arm was still sore to touch, but much less painful than the night before. In the afternoon it continued to be sore and uncomfortable, but did not impede daily activities.
50 2021-04-01 pain in extremity, numbness, feeling cold, tingling Left arm from shoulder to fingertips feels numb and tingly and like a chill/coldness running all dow... Read more
Left arm from shoulder to fingertips feels numb and tingly and like a chill/coldness running all down my arm starting day after shot and still continuing as of today.
50 2021-04-01 tingling symptoms started within 3-5 hours and lasted about 30 hours -cold (only lasted about 10 hours) -mild... Read more
symptoms started within 3-5 hours and lasted about 30 hours -cold (only lasted about 10 hours) -mild fatigue -mild headache -moderate soreness at injection site (followed by mild soreness for another 48 hours) -mild nerve tingling along trigeminal neuralgia locations: the left side from top of head, down the left side face/ear, down the left side of neck -mild nerve tingling in left arm
50 2021-04-01 slow speech Immediately after getting shot, I experienced the following: extreme drowsiness, dizziness, redness ... Read more
Immediately after getting shot, I experienced the following: extreme drowsiness, dizziness, redness all over, and feelings of being intoxicated?slow to speak hard to gather my thoughts. Was taken to ER and given Benadryl shot and another IV medication. While in ER both my hands swelled.
50 2021-04-01 tremor dizziness , Fainting, loss of consciousness , shaking ,chills, may be seizure
50 2021-04-02 facial paralysis, slurring Slurred speech, drooping on right side of face, headache. Drs. Wanted to rule out a stroke so CT Sca... Read more
Slurred speech, drooping on right side of face, headache. Drs. Wanted to rule out a stroke so CT Scan, MRI, Echocardiogram and numerous of blood test. 48 hrs the symptoms can completely subsided
50 2021-04-02 feeling cold had a little heart palpitation; achy; like a muted flu; runny nose; nose felt like it was burning on... Read more
had a little heart palpitation; achy; like a muted flu; runny nose; nose felt like it was burning on the inside; Sneezing; chills; feeling feverish; Elbow or right arm muscle was contracting or moving on its own; Heart fluttering; always cold; This is a spontaneous report from a contactable consumer (patient) via the medical information team and a Pfizer-sponsored program, COVAX US Support. This consumer reported similar events for two patients. This is the first of two reports. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 10Mar2021 11:30 (lot number: EN6204, expiration date: Jun2021) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included lupus from 2012 and ongoing; blood clot disorder from 2017 and ongoing, heart attack from 2010 and ongoing: heart attack/heart condition; stroke in 1992 and ongoing; Sjogren's syndrome from 2012 and ongoing; ongoing allergies to all sulfas, penicillins, latex (no manufacturer lot or expiration date); allergic to dye they put in CAT scans; obese from 2014; gastric bypass from 2014 and pulmonary embolism: rare and grew in her lungs in 2017 and was on apixaban (ELIQUIS) for that now. Concomitant medications included apixaban for pulmonary embolism and blood clotting disorder. The patient had no prior vaccinations within 4 weeks. The patient received a rubella shot and came down with German measles. Family medical history included a large family history of thoracic aortic dissections associated with vascular Ehlers-Danlos syndrome (EDS). The patient experienced heart fluttering on 10Mar2021 at 11:30; elbow or right arm muscle was contracting or moving on its own on 11Mar2021 at 15:00; chills and feeling feverish on 12Mar2021 at 22:30; nose felt like it was burning on the inside and sneezing, on 16Mar2021 at 10:00; achy in 19Mar2021; runny nose, like a muted flu, always cold and had a little heart palpitation in Mar2021. The patient received her first dose on 10Mar2021 and 2 days after she started having chills and feeling feverish. The patient had fever twice. A day before (18Mar2021) she had a slight fever, runny nose and chills. On 19Mar2021, she had chills, achy and felt like she has a fever, but she doesn't have a fever. It was like a muted flu; it was not horrible but can be debilitating at times because she can't function and was always cold. She constantly has chills, then her nose feels like it is burning on inside and she sneezed a few times. She added that 3 days before getting the vaccine (07Mar2021) she was not feeling well and had a rapid COVID test done and it was negative. The day of the actual day of vaccine the patient was okay. The patient has lupus and a blood clotting disorder for which she takes apixaban. She continued that she has not been out of the house since Mar2020. When she got the shot she had a little heart palpitation. She does not know why she was feeling this way after all these days. She wanted to know how long this would last and should she get tested for COVID. There was a lady that was sick when she got vaccinated and they allowed her in. The heart fluttering felt like it was in esophagus at first. It felt like it was going down her throat. It lasted only a couple of hours. She heard that from other people (her sister). No ER or physician's office required. The patient wanted to know how long the side effects were going to continue. The patient wanted to postpone her second dose until after Easter and her birthday, she did not want to be sick during that time. She has re-scheduled her second dose for 05Apr2021. Her son was getting married 27Jun2021 and she saw a study that immunity was still high at 62 days. The patient wanted to know if she would still have immunity or high antibodies on 27Jun2021 or would it still be effective. The outcome of achy, runny nose, like a muted flu, always cold and had a little heart palpitation was unknown. The patient has not recovered from chills and feeling feverish. The patient was recovering from the remaining events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021312325 Same reporter, same drug and similar event, different patient.
50 2021-04-02 feeling cold Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Medium, Syst... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Additional Details: Patient received vaccine and reported feeling dizzy upon standing after the 15 minute observation period. Pt complained of dizziness, headache, double vision, and feeling a cold sensation in her body. After the patient started feeling symptoms, the family reported that she is menstruating, fasting, and has not eaten since 2 am. EMS was called and patient was taken to the ER.
50 2021-04-02 pain in extremity Chills, headache, dizziness, vomiting, sharp pains in temple, right hip and arm, body aches, insomni... Read more
Chills, headache, dizziness, vomiting, sharp pains in temple, right hip and arm, body aches, insomnia
50 2021-04-02 tingling Tingling in right arm.
50 2021-04-02 tingling right side of nose feels like it went numb congested, but no congestion/Whole right side of nose and... Read more
right side of nose feels like it went numb congested, but no congestion/Whole right side of nose and nostril went numb/could not feel/It was like it was numb on inside but not on outside; right side of nose feels like it went numb congested, but no congestion/It is congested in a weird way/ cannot blow nose; Headache; Pain at injection site; Weird tingling and ringing in right ear; Weird tingling and ringing in right ear; Nausea; Anxiety /Anxiety worsened/spiked when she could not feel her nose; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in the left arm, on 09Feb2021 13:00, as single dose, for prevention/COVID-19 immunization. Medical history included severe allergies to environmental, sensitivities to some foods, anemia and severe asthma diagnosed in 1973. The patient reported that her dad has COPD, emphysema, high blood pressure, asthma and allergies. Concomitant medications included azelastine hydrochloride (AZELASTINE) taken for allergies from Dec2020; fluticasone propionate (FLONASE) taken for allergies; and an unspecified steroid for asthma. Historical vaccine included live flu vaccine received 20-30 years ago and she was severely ill and sicker than she has ever been as on the brink of going to the ER, but she did not go. On 09Feb2021 at 13:20, 20 minutes after the vaccination, the patient experienced nausea which lasted for 2 hours; and anxiety. The patient never vomited. On 09Feb2021 at 16:00, 3 hours after the vaccination, the patient experienced pain at injection site and weird tingling and ringing in right ear. On 09Feb2021 at 17:00, 4 hours after the vaccination, the patient experienced headache. On 10Feb2021 at 11:00, the patient's right side of nose felt like it went numb congested, but no congestion, could not feel. The whole right side of nose and nostril went numb. It was congested in a weird way and could not blow her nose. The congestion felt like it was plugged but it was different from congestion. It was like it was numb on inside but not on outside. She wanted to know if this was normal. It was reported that her anxiety worsened/spiked when she could not feel her nose. The patient wanted to get shingles vaccine and asked if she should wait, if she should get the second dose of the COVID-19 vaccine and does she have increased risk because of her first dose experience. The patient had negative COVID test in Jan2021. The patient recovered from the event nausea on 09Feb2021 at 15:20; was recovering from pain at injection site, "weird tingling and ringing in right ear", headache, "right side of nose feels like it went numb congested, but no congestion/whole right side of nose and nostril went numb/could not feel/it was like it was numb on inside but not on outside" and "right side of nose feels like it went numb congested, but no congestion/it is congested in a weird way/ cannot blow nose". The outcome of the event "anxiety /anxiety worsened/spiked when she could not feel her nose" was not recovered. Information on the lot/batch number has been requested.
50 2021-04-03 pain in extremity, burning sensation Foot pain overnight first night leading to stabbing foot pain in left foot, hardly able to walk by e... Read more
Foot pain overnight first night leading to stabbing foot pain in left foot, hardly able to walk by end of day Sunday. (Nextday). Saw pediotrist to be sure no physical problems with foot and there were not. Had no issue prior to shot. Pain got better by day 4 but still have prickly feelings and sensations in hands and feet.
50 2021-04-04 weakness Within a few seconds of getting shot I had immediate strong metallic taste in my mouth. My left arm ... Read more
Within a few seconds of getting shot I had immediate strong metallic taste in my mouth. My left arm ( arm that received vaccine) turned red and splotchy , chest and face then turned red and splotchy. I felt lightheaded and my tongue and throat felt thick and like ?fuzzy? feeling. EMT put me on stretcher, gave me O2 and took BP...BP was higher than normal but not so high that was concerning. O2 was ok. I was monitored for 30 min then released. I felt weak the remainder of the day. The next day I was very ill, fatigued , body/joint aches, chills, sweats, bad headache, nausea, diarrhea- no fever. This lasted three days.
50 2021-04-04 feeling hot, weakness 20 minutes after shot, I experienced a warm sensation move across my chest. I began having a headach... Read more
20 minutes after shot, I experienced a warm sensation move across my chest. I began having a headache in the right temple. These two effects lasted 30-40 minutes. I began to feel a little better so I returned to work. On Friday 3-26-2021 I began feeling extremely weak and muscle aches. My heart rate was also elevated. I continued to feel bad and wasn?t able to return to work. I went to the Dr on 4-01-2021. Heart rate and blood pressure were both elevated. I had bloodwork and ekg done. Heart was in Tachycardia. All bloodwork was normal. I haven?t returned to work because of these symptoms
50 2021-04-04 flushing itching, hives on chest, flushed cheeks, thickness feeling in throat that began about 1.5 hrs after ... Read more
itching, hives on chest, flushed cheeks, thickness feeling in throat that began about 1.5 hrs after receiving second vaccination - relieved by 50mg of Benadryl. Itching persisted and controlled with Benadryl 25mg every 4-6 hours for the following two days. So far today, I have not taken any Benadryl, but am still feeling slightly itchy.
50 2021-04-04 migraine Severe headache similar to migraine started about 5 hours following vaccine. Took excedrin migraine ... Read more
Severe headache similar to migraine started about 5 hours following vaccine. Took excedrin migraine with no improvement.
50 2021-04-04 pain in extremity Headache onset 03-Apr2021 at approximately 02:30 EDT continues as of submission of this AE. Arm pain... Read more
Headache onset 03-Apr2021 at approximately 02:30 EDT continues as of submission of this AE. Arm pain onset 02-Apr-2021 at approximately 18:00 EDT continues as of submission of this AE.
50 2021-04-04 pain in extremity My arm was sore by that evening. The next day, I got swelling in my armpit. There was no indention f... Read more
My arm was sore by that evening. The next day, I got swelling in my armpit. There was no indention from my armpit when I raised my arm. It looked different from other arm (completely). It was very swollen. No doctor visit. I took Advil after taking the pharmacist and she told me to take Advil. That helped with the swelling.
50 2021-04-04 tingling, pain in extremity 2/11/21, Received shot on Thurs, no immediate side affects other than slight tingling on tip of tong... Read more
2/11/21, Received shot on Thurs, no immediate side affects other than slight tingling on tip of tongue and upper lip, extremely small red spots on my right wrist and soreness of right arm near injection. 2/12/21. Friday evening. Fever, chills and headache. Continued numbness/tingles on my tongue and lips. Tongue only slightly swelled three times. 2 weeks following: Drug rash/hives continued to try to appear every evening daily right before I took another Zyrtec. Needle pricks or itchy on my skin. Continued tingling/numbness sensation on tip of tongue and around mouth. Allergist had me on three 24-hour antihistamines. 8am Allegra, 2pm Zyretec, 8pm Zyrtec. 3/12/21 - Drsuggested going down to 2 Zyrec's per day 8am and 8pm. Did and was fine except continued on/off tingles/numbness on my tongue. Also increased facial tingles and numbness. The pink splotches on skin only appeared late one evening and went away, no full blown drug rash or hives, just a few needle pricking sensations on arms. 3/23/21 - Decreased to 1 Zyrtec @ 8pm per allergist. I am still feeling continued face and tongue pricks, tingles, numbness. 4/4/21 - A little tongue swelling late evening along with tongue and face tingle sensations. Finally went away and started again on 4/5/21. I am still taking only 1 Zyrtec every evening @ 8pm. Still throughout the day I continue to suffer with face/nerve tingles, pricks, tightness on my entire face, chin and throat. Tip of tongue on/off numbness. Submitting as Drhas not sent VAERS my latest allergic reaction report so said I will submit. I am getting very nervous and worried that symptoms have not gone away at almost exactly 2 months after my 2nd shot.
50 2021-04-05 feeling hot Pfizer-BioNTech Covid-19 Vaccine EUA Adverse effects were a low grade fever (99-99.9), feeling hot,... Read more
Pfizer-BioNTech Covid-19 Vaccine EUA Adverse effects were a low grade fever (99-99.9), feeling hot, headache, tired, sore arm muscle at injection site Effects lasting 2 days
50 2021-04-05 numbness, tingling Shortly after receiving the 2nd covid vaccine, I began to experience numbness and tingling in the le... Read more
Shortly after receiving the 2nd covid vaccine, I began to experience numbness and tingling in the left hand middle finger and left foot. Nothing seems to alleviate the symptoms and it is a daily occurrence. I find myself shaking and rubbing my hand and tapping my foot to improve the sensation. I have a doctors appointment scheduled.
50 2021-04-05 numbness, tingling A sudden on set of dizziness or feeling of vertigo, loud buzz in my head, nausea, pain at back base... Read more
A sudden on set of dizziness or feeling of vertigo, loud buzz in my head, nausea, pain at back base of neck, numbness and tingling in face and hands, strange feeling in throat almost like a lump, extreme fatigue . It was not debilitating but I did not feel well enough to drive my car. Symptoms started March 22 and all have dissipated except feeling dizziness and buzz noise in my head.
50 2021-04-05 muscle twitching Extreme fatigue beginning at 5AM day after vaccine injection, resolving the following morning (total... Read more
Extreme fatigue beginning at 5AM day after vaccine injection, resolving the following morning (total of ~24 hours) Arm twitching at vaccination site beginning day after vaccine injection - ongoing (now 48 hours) I also had a major headache after the first dose (6 weeks ago) that resolved within 24 hours
50 2021-04-05 pain in extremity, tingling muscle soreness, chills, sudden pains in legs, lower back and middle back, pins and needles down leg... Read more
muscle soreness, chills, sudden pains in legs, lower back and middle back, pins and needles down legs, up spine, out of sorts in head, vertigo, pulsating from within, armpit sore lt
50 2021-04-05 pain in extremity sore arm for 3 days
50 2021-04-05 pain in extremity Swollen lymph nodes left armpit, pain along arm, some pain in jaw Extreme tiredness, lots of naps, b... Read more
Swollen lymph nodes left armpit, pain along arm, some pain in jaw Extreme tiredness, lots of naps, bit of brain fog
50 2021-04-05 pain in extremity I could not work but my knees hurt so bad. I had an arthritis pain in my joints, wrist knee and my f... Read more
I could not work but my knees hurt so bad. I had an arthritis pain in my joints, wrist knee and my fingers. I was in a lot of pain and limping at the end of the day. I went to the ER and they did tests. A few days later I developed a rash on my thighs and when it started to spread to the other thigh. It looks like hives and it is was very itchy. The rash then appeared on my buttock and then to the other side. It proceeded to spread in patches in different areas of my body and then spread to the contralateral side of the same body area. I had swelling in my right hand on two fingers. A month after vaccination I also got a fever. All tests were negative except my CRP was elevated each time. I was prescribed Prednisone, but the rash still appears periodically, and my joints still hurt after 12 weeks. The rash is not as itchy when it appears. I have had another course of Prednisone after seeing the immunologist.
50 2021-04-05 tingling, facial pain, numbness Immediately experienced intense erratic nerve pulsations along left cheek. Left side of cheek and ja... Read more
Immediately experienced intense erratic nerve pulsations along left cheek. Left side of cheek and jaw felt numb and tingly. Jaw felt sore. I could feel the nerve pulsations with my fingertips very strong. The Pulsations continued on and off and subsided but the numbness tightness soreness and tingling feeling on the left side of my face lasted for about 36 hours until it completely resolved. 72 hours later the left side of my cheek still feels mildly sore or like a little tense at the jar hinge and under the skin. I also experienced dizziness and that lasted for most of the day I had trouble for instance focusing on things up close like washing dishes. I had to look further away. I also experienced an intense headache on the left side of my skull like a hammer pounding ten times at about 9 PM. Then it went away then the pounding came back again so Itook 500 mg Tylenol which seem to help but I still had a little bit of an ache in my jaw a few hours later so I took another 500 mg and that seem to resolve the headache and jaw pain. The next morning my face was still a little numb tingly and tight all day. It wasn?t until Sunday that it felt like it had finally resolved itself.
50 2021-04-05 seizure Started having mild to moderate seizures 4/5/2021. Continued off and on through 4//6/2021. Called D... Read more
Started having mild to moderate seizures 4/5/2021. Continued off and on through 4//6/2021. Called Dr. She said do not get a second dose. Monitoring symptoms still.
50 2021-04-06 weakness chills, dizziness, vomiting, diarrhea, fatigue, stomach cramps, weakness
50 2021-04-06 burning sensation 3/2/21 - Received 1st dose of Pfizer COVID-19 vaccine 3/3/21 - Rash on legs, itchy and burning in na... Read more
3/2/21 - Received 1st dose of Pfizer COVID-19 vaccine 3/3/21 - Rash on legs, itchy and burning in nature. Progressed to upper extremities and increased in severity over the following days.
50 2021-04-06 cold sweat, feeling cold Patient had vaccine 1130a, 1135a patient developed chest tightness, with intermittent sharp chest pa... Read more
Patient had vaccine 1130a, 1135a patient developed chest tightness, with intermittent sharp chest pain, midsternal, with dizziness, lightheadedness, and felt cold/clammy reported by patient. 1145a patient in observation on stretcher, with bp 120/88, rr 18, sao2 99% on ra. 1150a, patient denies sob and midtsternal sharp cp, but chest tightness remains, bp 104/66, rr 18, sao2 100% on ra. Discussed with patient pmh and ems transporting to ed for cardiac workup to roll out complications, patient in agreeance as chest tightness unrelieved. 12p ems arrived to location, bp 117/71, rr 16, sao2 99% on ra, chest tightness remains but all other s/s resolved, departed with ems after report given in stable condition, transported to hospital. spouse notified by patient.
50 2021-04-06 facial pain On 4/5/21 I got nausea and chills for about an hour. I woke up on 4/6/21 and my right eye and all bo... Read more
On 4/5/21 I got nausea and chills for about an hour. I woke up on 4/6/21 and my right eye and all bone structure on the left side were very painful. It did get worse throughout the day. I woke up on 4/7/21 and the same symptoms with my face and eye but appear to be lessened. But as I am trying to fill out the form it is starting to hurt a little more. Slight swelling in the left eye.
50 2021-04-06 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: SHE... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: SHE FELT ANXIOUS, FELT DIZZY AND SWEATING, WE TOOK HER BLD PRESSURE 104/75 HR 68. AFTER SHE RELAXED AND LIE PAT DOWN AND ELEVATE FEET,. SHE FELT BETTER HER BLD PRESSURE WENT UP TO 113/82 HR 80. O2 ST 98%. FOLLOW UP WITH HER ON 4/7/2021. SHE FELT COMPLETLETY FINE.
50 2021-04-06 hot flush Vomiting, Headache, Nauseous, hot flashes extremely exhausted
50 2021-04-06 nerve pain 6 days after I received the 2nd pfizer vaccination in my left arm, I started to experience a deep du... Read more
6 days after I received the 2nd pfizer vaccination in my left arm, I started to experience a deep dull ache in my arm at the vaccination site. This has been getting progressively worse and feels like nerve pain. I am having increased pain when I try to raise my arm. I am typing this form 7 days after the shot.
50 2021-04-06 pain in extremity, migraine IMMEDIATELY I started to get a headache which turned into a migraine that night. Migraine lasted 2 d... Read more
IMMEDIATELY I started to get a headache which turned into a migraine that night. Migraine lasted 2 days. within 24 hours i did get a low grade fever that only lasted less than 11 hours. 24 hours after I had a sore arm and my lymph nodes were swollen under my arm and near my collar bone. I was very sore in the lymph nodes area.
50 2021-04-06 pain in extremity On Monday, the same day as the shot... Towards the evening left arm hurting: like someone punched me... Read more
On Monday, the same day as the shot... Towards the evening left arm hurting: like someone punched me really hard in the arm (like it did after the first shot) Around 8 PM or so, I started to feel achy and sore, like I had been working outside all day moving heavy items. My whole body was sore. Woke up the next morning and felt off. Took my temp. and it read 101. I took Tylenol. Pretty much stayed in bed the whole day. I was tired and achy. Fever went up to 103 at around 4 PM. Took Tylenol. By the evening I was feeling better. Next morning I woke up. Not achy but not 100percent. Fever at 99, but now I'm dizzy. (This is written on 4-7-21 2:40 pm)
50 2021-04-07 weakness Dizziness began 7 days after first dose and as of 5 weeks later still has not stopped. Lightheaded e... Read more
Dizziness began 7 days after first dose and as of 5 weeks later still has not stopped. Lightheaded every day, sometimes heavy dizzy spells. Almost fainted once. The lightheadedness sometimes clears after a short walk outside, but then returns the next day. I was completely fine and extremely active physically up until receiving the first dose. In addition to the dizziness, my energy has been effected. It took an extreme downturn 5 days after the first dose. I have not regained my normal health or routine since receiving the first dose.
50 2021-04-07 bell's palsy, numbness She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My fac... Read more
She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My face went numb; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer, the patient reported for herself that a 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Mar2021 (at the age of 50-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included prednisone (MANUFACTURER UNKNOWN); valaciclovir hydrochloride (VALTREX) (MANUFACTURER UNKNOWN). On an unknown date, the patient experienced bell's palsy but upon contacting her physician she was prescribed an immunosuppressant which is Prednisone. She was asking if she can take the second dose. Patient stated, after about a week of first dose on an unspecified date in Mar2021, she got dizzy and started bleeding out of nose. On an unpecified date in Mar2021, 2 weeks in, she thought she had an earache. It started on Sunday, Monday and Tuesday. On an unspecified date in Mar2021 (Wednesday), the first thing she noticed while driving was eyes were kinda blurry and her face went numb and she couldn't close eye. Within 2 hours of numbness she saw the doctor who put her on Valtrex and later her doctor put her on prednisone. She has the 2nd dose scheduled for Monday 05Apr2021 and she is worried about taking it. The clinical outcomes of the she experienced bell's palsy, dizzy, bleeding out of my nose, earache, eyes are kinda blurry, my face went numb were unknown. Information about lot number has been requested.
50 2021-04-07 burning sensation Shingles (pain and burning started 24 hours after injection, rash appeared 5 days later, still curre... Read more
Shingles (pain and burning started 24 hours after injection, rash appeared 5 days later, still currently experiencing symptoms)
50 2021-04-07 feeling hot Injection site pain Tiredness Severe headache Brain fog Muscle pain Joint pain Chills Hot sweats Fev... Read more
Injection site pain Tiredness Severe headache Brain fog Muscle pain Joint pain Chills Hot sweats Fever (101) more than 24 hrs Nausea Sore throat
50 2021-04-07 numbness, tingling Tingling/numbness in both arms immediately following injection, fever, body aches for more than 24 h... Read more
Tingling/numbness in both arms immediately following injection, fever, body aches for more than 24 hours.
50 2021-04-07 migraine Migraine D1, Migraine D2, D3 chills, shortness of breath, heart palpitations, tinnitus; called MD at... Read more
Migraine D1, Migraine D2, D3 chills, shortness of breath, heart palpitations, tinnitus; called MD at Clinic, RN spoke to told me to go to the ER since I had to keep pausing conversation to breathe. SOB lasted 3-4hrs and was gradually improving as I drove to ER. Tinnitus not improved, Chills improved, SOB severe improved but still occasional mild SOB, Palpitations improved, Migraines improved
50 2021-04-08 weakness, tremor 4 am: 2 hours of chills and violent trembling. My teeth were clenched so tight for so long, my jaw a... Read more
4 am: 2 hours of chills and violent trembling. My teeth were clenched so tight for so long, my jaw ached. 6 am: I couldn?t lift a glass of water. Someone brought my cup and straw, which I nestled between my face and pillow. I sipped what I could. 6:30: Sleep 8:am: Woke up thinking it was 6pm. I couldn?t roll over. Dizzy and weak, I collapsed back into bed from trying to stand. Someone walked me to the bathroom. Once there, I wheezed and gasped for air. Then I got scared and cried, which made it even harder to breathe. It felt like my body wasn?t absorbing the oxygen it took in. 8:05: Sleep 9 am: Woke up hoping the day was almost over and I slept through it. The cruelest part is sleeping what felt like the deepest sleep only to wake up an hour later ? over and over again. My spine and neck ached, which made my head hurt ? or my head hurt all on its own. 12 pm: Sharp abdominal pains with any movement. If I did move, I had fits of gasping for air. Had to ask Someone for the phone sitting just a foot away. I couldn?t look at the screen. My eyeballs were too sore, head too achy, and brain too fogged. The phone was only to ask for help while someone worked in the other room. 12:30: Abdomen sore to touch. Hard to talk. My bowels became so shut down it hurt(s) to move straight water through them. The rest is kind of a blur. Lots of sleep. In the afternoon, someone walked me to the bathroom. Back in bed, I had another breathing fit. My abdominal pain felt inescapable. Through was happy for his company, I think I fell asleep during our conversation. At some point, someone brought me broth but I didn?t get much down. By evening, I could walk to the bathroom alone, albeit hunched like a 120 year old in need of a walker. My guts just hurt too much to stand upright. Day 2: I still suffer from abdominal pain, a headache and muscle aches, but I CAN roll over, lift a glass of water, and focus on a screen for short stints. (I documented this in stages.) I can walk slowly but still painfully to the bathroom without help, but I get winded beyond that. I?m afraid to eat with my digestive tract so inflamed, but I have far more energy today, 32 hours after my last meal, than I did yesterday. I?ve also lost 6 pounds. Day. 3: 10 pounds down, still with diarrhea, but eating again. Restless sleep. Significantlt winded and dizzy after mild activity, like walking from one side of the house to the other.
50 2021-04-08 feeling cold On 4/04, muscle aches, fever, chills, vomiting. 0n 4/05, chills continue, dizziness, nausea. Still... Read more
On 4/04, muscle aches, fever, chills, vomiting. 0n 4/05, chills continue, dizziness, nausea. Still dizziness on 04/09, time of submittal.
50 2021-04-08 muscle spasms, tremor Two straight days of maintained fever between 100.9 & 102.2, full body shaking/chills, muscle cramps... Read more
Two straight days of maintained fever between 100.9 & 102.2, full body shaking/chills, muscle cramps, nausea.
50 2021-04-08 night sweats, pain in extremity My last period (menses) was Sept 1, 2019. I am post menopausal with 18 months since my last period. ... Read more
My last period (menses) was Sept 1, 2019. I am post menopausal with 18 months since my last period. However, this morning I had a regular period, not just spotting. I also had night sweats for a week after my first dose and have had night sweats for the past week and a half since my second dose. Reporting this as it seems my period could be vaccine-related and I saw some reports on-line of others saying it may affect their periods. My only other symptom was fatigue and a sore arm, both already expected.
50 2021-04-08 pain in extremity Severe arm pain in left arm, nausea, fatigue, rash, swelling, and pain under left arm
50 2021-04-09 weakness Approximately 2:30pm, on 4/3/21, I started developing very bad lower back pain, which made it very u... Read more
Approximately 2:30pm, on 4/3/21, I started developing very bad lower back pain, which made it very uncomfortable to stand or sit. By 8pm, I was asleep for the night, not awakening until 8am on 4/4/21. I woke up with very little energy and had body aches. My temperature was 99.5 and I slept on and off for the whole day. During the overnight hours of 4/4/21 to the morning of 4/5/21, I maintained a temperature of 100 and went from chills to feeling feverish. I woke up on 4/5/21 and had severe head and chest congestion and no energy, which caused me to call out of work on 4/5/21. A cough developed the afternoon of 4/5/21 and my temperature on 4/6/21 was 100.5, so I missed a second day of work. By 4/7/21, I no longer had body aches and no more fever. I did have a productive cough until 4/8/21. On 4/9/21, my cough became dry. As of today, 4/10/21, all adverse events are just about gone. My treatment was Vicks daytime liquid medicine and tylenol through 4/8/21.
50 2021-04-09 discomfort, pain in extremity Woke with elevated fever at 3:00 AM. At highest, fever was 2.3 degrees above my normal. Loss of appe... Read more
Woke with elevated fever at 3:00 AM. At highest, fever was 2.3 degrees above my normal. Loss of appetite. Fever sweats. General discomfort. Slight pain in arm. Extreme fatigue. Treated with two Tylenol and sleep. Most symptoms disappeared within 24 hrs of the shot except for the following: one-degree temperature on the second day (took more Tylenol); and extreme fatigue for nearly five days before it started to taper off. I was unable to perform normal daily activities during that time ,due to the fatigue, including my job. Treatment: sleep, rest and time.
50 2021-04-09 flushing Patient experienced flushing/sweating, dizziness, spacing out. Had two puffs of albuterol inhaler at... Read more
Patient experienced flushing/sweating, dizziness, spacing out. Had two puffs of albuterol inhaler at 11:08. VS at 11:15 - BP 149/90, HR76, RR18. VS at 11:33 - BP 146/84, HR75, RR18. Patient given water and crackers. Patient stable and released from vaccination site
50 2021-04-09 numbness, feeling cold, hypersensitivity of all senses Numbness, cold sensation, and sensitive to touch on left upper thigh night of injection. 1 day after... Read more
Numbness, cold sensation, and sensitive to touch on left upper thigh night of injection. 1 day after injection, patient had same feeling on right wrist. Patient was vaccinated on left arm. Headache was also present day 5 post injection. Patient also reports fatigue since vaccination.
50 2021-04-09 numbness, muscle spasms Extreme fatigue, chills, low fever, all over body aches, headache, numbness in all extremities, musc... Read more
Extreme fatigue, chills, low fever, all over body aches, headache, numbness in all extremities, muscle spasms throughout my body.
50 2021-04-09 pain in extremity I developed skin rashes on my left bum and left leg is now showing signs of rashes, also diarrhea. A... Read more
I developed skin rashes on my left bum and left leg is now showing signs of rashes, also diarrhea. Also I have weird pain in my left hamstring/leg. I have not seen my doctor.
50 2021-04-09 tingling Left side of my face and entire tongue got pins & needles feeling about 17 minutes after shot. was g... Read more
Left side of my face and entire tongue got pins & needles feeling about 17 minutes after shot. was given a shot of Benadryl. For the next 4 days the sensation would repeat and I controlled it with Benadryl. My neck and face were swollen. The sensation also spread to left arm in the following days. Starting 4/7/21, the pins and needles feeling has returned to my left face. The swelling has never completely gone down on the left side of my face. The tingling is worse today and my body is itching.
50 2021-04-09 tremor Arm vaccine given swollen and red and hot, had fever 100-102 within hours for 5 days, joints hurt, s... Read more
Arm vaccine given swollen and red and hot, had fever 100-102 within hours for 5 days, joints hurt, shakes to point of not able to pick up glass of water, headache, extreme thirst, extreme tiredness and sleepy. I had vaccine on Wed. and had all of these symptoms until I stopped my Lithium Sunday and by Wed. I was feeling better. I drank as much water as I could and restarted my Lithium due to the side effects I had from stopping and I no vaccine issues today 4/9/2021 my issues from medication is starting to settle down. I only stopped the Lithium which is 600mg a day - I take 4 pills that are 150mg each.
50 2021-04-10 weakness *Unexplained increases in heart rate (up to 165 bpm) over next 4-5 days following injection. During... Read more
*Unexplained increases in heart rate (up to 165 bpm) over next 4-5 days following injection. During sudden heart rate increases , I would feel sweaty and weak. *I also experienced mild fever, chills, and body aches for about 36 hours beginning about 6 hours after injection.
50 2021-04-10 burning sensation Next morning woke up with small rash on upper back right side that burned especially with clothing, ... Read more
Next morning woke up with small rash on upper back right side that burned especially with clothing, lasted all day but was gone by evening. Also I have postherpetic neuralgia from Shingles (diagnosed September 5, 2017). The pain is from the umbilicus to mid back spine on right side and somewhat controlled with Gabapentin and Nortriptyline. The burning pain was noticeably increased the next morning after the vaccine and lasted for about 48 hours.
50 2021-04-10 feeling hot 10 hours after my shot, I had a sudden wave of severe nausea, dizziness, and heat and fainted. I sla... Read more
10 hours after my shot, I had a sudden wave of severe nausea, dizziness, and heat and fainted. I slammed my face on the bathroom floor and broke my nose (among other cuts and bruises). After I fainted, the symptoms were gone except for the injuries from fainting and a slight fever and minor queasiness the next 2 days.
50 2021-04-10 feeling of body temperature change Diarrhea for 6 hours continuously and next day sporadic, headache with intense stabbing pain in base... Read more
Diarrhea for 6 hours continuously and next day sporadic, headache with intense stabbing pain in base of skull, nausea, abdominal cramping for 6 hours, hot and cold feeling, and insomnia. Sleep and Tylenol
50 2021-04-11 burning sensation, flushing I felt the injection burn as it was administered, but I thought nothing of it. When I sat down my h... Read more
I felt the injection burn as it was administered, but I thought nothing of it. When I sat down my heart rate became elevated almost immediately from 62bpm to 120bpm. I had flushing that started on my chest, neck and face. My face was hot to the touch and felt like a sunburn. My heart rate stayed elevated to 90 bpm for several hours. When a got back home I then had extreme GI upset. The flushing stayed warm and red until the following morning.
50 2021-04-11 numbness, tingling Numbness, tingling
50 2021-04-11 numbness Tightness in the throat , Numbness in fingers. tingling on the lips and tongue symptoms were gone in... Read more
Tightness in the throat , Numbness in fingers. tingling on the lips and tongue symptoms were gone in a matter of 30 minutes no treatment.
50 2021-04-11 numbness Chills, Fever, Muscles and joint pain, Severe headache and numbness in my legs (MS possible triggere... Read more
Chills, Fever, Muscles and joint pain, Severe headache and numbness in my legs (MS possible triggered from Vaccine) Nausea
50 2021-04-11 numbness Dizziness; numbness of the right arm; elevated blood pressure
50 2021-04-11 pain in extremity Fatigue 3/31-4/7 headache 3/30-4/2 extreme achy muscles 4/1-4/5 Fever off and on 4/2-4/8 painful up... Read more
Fatigue 3/31-4/7 headache 3/30-4/2 extreme achy muscles 4/1-4/5 Fever off and on 4/2-4/8 painful upper arm and somewhat swollen 3/31-4/5
50 2021-04-11 pain in extremity severe headache, severe pain in the left side and left arm, overall body aches
50 2021-04-11 tremor, feeling cold About 6-7 hours after shot, I started feeling achy and feverish. About 10 hours after the shot, I h... Read more
About 6-7 hours after shot, I started feeling achy and feverish. About 10 hours after the shot, I had uncontrollable shaking for about 2 hours. I was so cold, I could warm up all night. I had to clench my teeth to keep from biting my tongue. I also felt nauseous all that night and the next day. I couldn't lay flat that night or I felt like I would vomit. Once the shaking subsided (after 3 Tylenol), I still couldn't sleep because of the nausea and the aching. I got about 2 hours of sleep and woke in the morning with a massive headache. I took more Tylenol and it helped with the headache but had chills and nausea all day. I slept much of the afternoon and all that next night. The following day, I still felt a bit nauseous, achy and fatigued but much better than prior. By the following day, I was back to normal.
50 2021-04-12 bell's palsy Bell's palsy; This is a spontaneous report from a non-contactable consumer (Patient). A 50-year-old ... Read more
Bell's palsy; This is a spontaneous report from a non-contactable consumer (Patient). A 50-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: ER8727, expiry date: unknown), via an unspecified route of administration in right arm on 24Mar2021 at 09:00, (at the age of 50-year-old) as a single dose, for COVID-19 immunisation. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication was none. The patient previously took codeine and experienced allergies (known allergies_ codeine). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient experienced bell's palsy on 26Mar2021, at 07:00. The patient visited physician office and emergency room. The patient received steroids as treatment to the event. The outcome of the event was recovering No follow up attempts are possible. No further information is expected.
50 2021-04-12 feeling hot, flushing Within the first 5 minutes after the vaccination, I felt faint, lightheaded, dizzy, disillusioned, l... Read more
Within the first 5 minutes after the vaccination, I felt faint, lightheaded, dizzy, disillusioned, like I had vertigo also. I experienced these symptoms w/in the first 5 minutes once I left the designated vaccination area. My entire body felt hot, my face was red, I felt sweaty. I went to find a nurse nearby who walked me to an area to sit/rest so that she could monitor me. I did inform her that I had my EpiPen with me, however, she recommended that if I had Benadryl to take it immediately. She provided me w/water and I took one 25mg pill. She continuously took my pulse as I felt my heartbeat was fast, I had anxiety about the way I was feeling because I felt short of breath. While my throat/chest did not feel tight, I did feel a heaviness in my chest and my breathing was somewhat labored. My face became flushed and then pale/drained and I began to feel extremely nauseous w/in 10 minutes. The nurse continued to monitor/take my pulse/heart rate at this time. I did experience stomach cramps and had to go to the bathroom. I experienced diarrhea and continued to feel nauseous while in the bathroom. I continued to feel dizzy and just out of sorts so I was asked to remain at the hospital. I was asked if I'd like to be taken to the ER, however, I chose not to go to the emergency room because I did not want to incur any additional hospital charges if they were not going to utilize my EpiPen. I remained at Hospital vaccination clinic at the hospital for what I believe was approximately 2.5 hours. I did ultimately eat a small bag of pretzels and drank a small bottle of water. Thankfully, the Benadryl did help fairly quickly and tremendously to get me over the hump of symptoms and anxiety that I was feeling. Once I returned home, I literally just collapsed in bed and remained there basically sleeping for over the course of the next 48 hours. I followed a diet as my stomach was still upset. I did have a slight fever, but it did not get any higher than 99-100. I felt clammy the first day/evening, with subsequent chills, but ultimately, by Friday night and into Saturday, I felt well enough to get out of bed and move around the house. I felt back to some normalcy on Sunday. My left arm was swollen from Wednesday (day of vaccination) to Saturday. I could not lift my arm, or sleep on my left side due to the pain and I also couldn't lift my arm for approximately 48 hours.
50 2021-04-12 migraine, inability to speak, weakness On 4/5/21, two days after my second injection, I was sitting at my desk working (at home) when I not... Read more
On 4/5/21, two days after my second injection, I was sitting at my desk working (at home) when I noticed my vision wasn't clear even with my glasses on. I had been feeling nauseous for a few hours and then my eyes started bouncing back and forth uncontrollably. I was unable to see correctly or move from my chair. Once my eyes stopped moving my vision became tunnel vision and everything around it became foggy. I felt weak and dizzy. I started getting a headache. I didn't think I could even call out for help as I was unsure my voice would work. Once it all calmed down I figured it must be part of a migraine, even though nothing this extreme had ever happened before. I moved to my bed as I was suddenly completely exhausted, and immediately fell asleep for almost 3 hours. Once I got up I was still very groggy and had to force myself my. I stayed up for about 3 hours and went back to bed for the night. The next morning I woke and was feeling better so I figured it must have been a migraine. However a few hours later the same problems started back up again. I was having a hard time seeing my computer screen, I had a foggy head and was finding it hard to concentrate and do work. My headache started again and my vision started as foggy and became tunnel vision again. This time my eyes did not bounce, but my lips started tingling. This lasted for about 1 minute. This time with everything I was making sure to take a mental note of everything going on because I was scared I was going to have to call 911. Because I was home alone I opened my phone to dial if it got any worse. The event backed off enough that I took myself to the ER. By the time I was in the waiting room my head felt like a balloon and my whole body just felt "off." I can't explain how it felt, it just didn't feel normal. My headache never got overly severe like it does with a migraine, but I was worried about a stroke. The ER did a CT scan and did rule out a stroke, but was unsure of what it exactly what it was, but guessed it was an abnormal migraine attack and told me to follow up with my PCM in a couple of days and to keep my appointment with my neurologist on April 15th. The symptoms lasted a full week off and on every day, with a tampering down of severity of symptoms.
50 2021-04-12 migraine I occasionally get migraines. At the most 2-3 days a month but most months I don't get any. I pro... Read more
I occasionally get migraines. At the most 2-3 days a month but most months I don't get any. I probably have less than 12 migraine days per year. Since my second shot, I had 18/25 days with a migraine.
50 2021-04-12 pain in extremity First day, muscle pain in arm that lasted a day. Fourth to Sixth days, full body muscle aches, joint... Read more
First day, muscle pain in arm that lasted a day. Fourth to Sixth days, full body muscle aches, joint pain all over, severe chills, fever of 100.1 (normal temperature runs 97.9).
50 2021-04-12 tingling, numbness Within 1 hr of 2nd shot, experienced tingling/numbness in both arms&hands&right thigh, in addition t... Read more
Within 1 hr of 2nd shot, experienced tingling/numbness in both arms&hands&right thigh, in addition to heaviness in left arm. All day Sat had dull headache. Woke up Sunday morn with splitting headache, nauseous, dizzy. Checked BP it was 140/90 (for me anything above 130/80 gives me headaches, my typ high is 124/78). Then experienced tingling&numbness on both sides of face, upper back of head, hands, fingers, and legs. Numbness came and went. Monday afternoon walked up 3 flights of stairs (which I've been doing every day for almost 1 yr), but now experienced shortness of breath, heart palpitations. within 1 hr my entire face/back of head was numb, felt pressure in both of my ears, and both my hands, right leg became partially numb. Went to ER in evening since numbness persisted on/off, especially in face/head. Doc told me my potassium was a bit low & minor dehydration. Got cat scan & EKG--all ok. Was given potassium pill and fluids. While I was waiting, my entire right side (arm/face/legs) became numb for ~1 hr, then lessened up, and moved to left side. Was discharged, but continue to experience "rolling" numbness all over my body--mostly face/back of head, hands/fingers, and legs--but it's now also affecting lower back of head, and upper front & lower back as of Tuesday morning. Some heaviness in both arms, but again on/off. Haven't had another high BP episode from what I can tell. I've never been completely paralyzed per se, but simply tingling/partial or total numbness for long periods of time in all the above mentioned areas.
50 2021-04-12 restless legs syndrome Left hand ring finger and pinky swelling, bruising on pinky finger noted 7pm EST 4/8. Administered ... Read more
Left hand ring finger and pinky swelling, bruising on pinky finger noted 7pm EST 4/8. Administered 75mg Benadryl liquid, applied ice that evening 4/8, Administered 20mg loratidine and 1000mg Tylenol 4/9 am. Swelling resolved by 4/10, bruising resolved by 4/11. Restless leg 4/8 at bedtime. Left knee pain 4/9.
50 2021-04-13 burning sensation headache, burning on face, chest and ear about 2-3 min after vaccine. Took benadryl
50 2021-04-13 face paralysis, slurring The patient is a 50 year old female with no medical problems who developed sudden severe headache on... Read more
The patient is a 50 year old female with no medical problems who developed sudden severe headache on 3/24 accompanied by nausea and vomiting. She presented to urgent care on 3/25 and was considered to be dehydrated and given IV fluids. On 3/27 she developed left hand weakness. On 3/29 she revisited urgent care with residual symptoms plus hand weakness and was sent to hospital where she was admitted and MRV demonstrated Cerebral Venous Sinus Thrombosis of the sagittal sinus, right transverse sinus, and right sigmoid sinus. The left transverse sinus may also be occluded or congenitally absent. There was no evidence of hemorrhage or stroke. The patient was admitted and started on heparin then transitioned to Eliquis and discharged. On 4/3, she had worsening of symptoms consisting of dysarthria, left facial, and worse left arm and hand weakness. She was readmitted to hospital then transferred to hospital for further management.
50 2021-04-13 feeling hot, depressed level of consciousness Walked a few minutes after received vaccine, walked with son toward observation. Pt reports feeling ... Read more
Walked a few minutes after received vaccine, walked with son toward observation. Pt reports feeling hot, agitated, dizziness, nausea, placed on w/c to medical bay. Placed in gurney - had oatmeal for breakfast - states feeling HA/nausea. HA 8/10 dizzy 10/10, +room spinning. PERRL, slight diff to arouse. Unable to walk d/t dizziness/drowsiness. Alert to name, place, vaccination area. 0 difficulty breathing, able to answer questions, slower to respond. Similar s/x >1 year ago d/t stress related son went to ER, dc'ed from ED). Son reports feeling fatigue for past 2 months. Son reports heavy menstrual period stopped 2 months ago p son. BP 131/84; HR 70 RR 16; Sat 98% on RA.
50 2021-04-13 muscle twitching, tingling, pain in extremity Second shot was given at 4:45pm; slight headache and sore arm around 8pm. Around midnight i was awa... Read more
Second shot was given at 4:45pm; slight headache and sore arm around 8pm. Around midnight i was awaken with my face twitching. More on my right side. This continued till about 4am. But I also felt pins and needles throughout my entire face. Around 3pm, i had swelling in my face to the point my eyes were close. Swelling got a tad better around 5am. Pins and needles continued till about 11am on 4/1/2021. I emailed primary doctor with a picture of my face. The nurse called me about 8am, and I told them that the swelling was going down. I was extremely tired since i was up all night....i went back to sleep and called the nurse office around 10am and said i was getting better.
50 2021-04-13 pain in extremity, weakness Developed lymphadenopathy in left axilla that then developed into lymphedema in left arm. Also had w... Read more
Developed lymphadenopathy in left axilla that then developed into lymphedema in left arm. Also had weakness and pain in left arm. After 1 day also had lymphadenopathy and lymphedema in right arm. Had associated pain in bilateral hands, wrists, and forearms. Symptoms gradually resolved over 2 week time span.
50 2021-04-14 weakness, feeling cold When i took the first does, i passed out the morning after the vaccine and had fever for 2 days. I ... Read more
When i took the first does, i passed out the morning after the vaccine and had fever for 2 days. I also had body ache and a light cough. The second dose, i had sever chills starting within 3 hours of the injections. Thru out the night i was freezing but my skin was hot to the touch and i had a fever. The second day i was very sensitive to light and sounds. I couldn't keep my eyes open and had no energy to do anything. I had chills the whole day. I was bundled in 3 blanket and still shivering. The following day i couldn't remember the event of the prior day. It felt as if i was in fog the whole day. Note: I have COVID end of January 2021
50 2021-04-14 facial paralysis numbness of tongue and lip, clinching of teeth, left sided dropping of mouth
50 2021-04-14 hot flush Day 1- body aches, fatigue Day 2 - headache, decreased bodyaches, fatigue Day 3 - chills, heat flash... Read more
Day 1- body aches, fatigue Day 2 - headache, decreased bodyaches, fatigue Day 3 - chills, heat flashes, headache, fatigue
50 2021-04-14 numbness, pain in extremity Approximately 20 minutes after waiting my entire body including my face and mouth became numb. Ther... Read more
Approximately 20 minutes after waiting my entire body including my face and mouth became numb. There was some swelling of tongue but mainly just felt dry. I was advised that I should go to the ER by ambulance. I had no anaphylactic symptoms. They took a metabolic panel which was fine. After 2 hours they sent me home. The full body numbness lasted 24 hours with residual numbness on my left side especially my left forearm and hand lasting a few days. Since then my fingers have felt sore at time kind of like an arthritic pain.
50 2021-04-14 migraine blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, sho... Read more
blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, shortness of breath, extreme blood pressure immediately upon injection for 1 hour. Continued reactions 48 hours, extreme fatigue, blood pressure, dizziness, metal and bitter taste in the mouth, migraine, stomach upset, red polka dots on hands, itchiness underarms, cough, sore throat, and fever
50 2021-04-14 pain in extremity ARM OF INJECTION IS STILL VERY SWOLLEN AND SORE. LOTS OF MUSCLE FUNCTION IN SITE ARM.
50 2021-04-14 pain in extremity Chills, feverish, muscle aches, headache, severe fatigue, vomiting (couldn't keep down water or spor... Read more
Chills, feverish, muscle aches, headache, severe fatigue, vomiting (couldn't keep down water or sports drink the first day) No appetite, sore arm
50 2021-04-14 tremor Dizzy, Shaking.
50 2021-04-15 weakness Low fever, severe fatigue, weakness, muscle pain everywhere -- fatigue and weakness lasted one week;... Read more
Low fever, severe fatigue, weakness, muscle pain everywhere -- fatigue and weakness lasted one week; rash developed about 2 weeks after first dose on forehead and after second dose became worse on forehead and spread to cheeks, chest and neck. Still have light rash on areas but it appears to be going away slowly.
50 2021-04-15 weakness Day 1: 3PM Sore throat, 11PM facial swelling, 4AM panic attack Day 2: 2PM, lasting for 3+ hours: N... Read more
Day 1: 3PM Sore throat, 11PM facial swelling, 4AM panic attack Day 2: 2PM, lasting for 3+ hours: Nausea, dizzy/faint/weakness, rapid heart rate (120-150 BPM), elevated blood pressure, chest pain and pressure, bronchoconstriction, pharyngeal constriction, sore throat, burning tongue, tinnitus ; 5PM chills, temp up to 101.5, intense lower back pain, headache, anxiety Day 3: intense headache, lower back pain Day 4: Mild headache, depression and fever blister later in the day Day 5: Deep depression, feeling of impending doom Days 6-16: Elevated anxiety, chest pain and pressure, bronchoconstriction, pharyngeal constriction, sore throat, burning tongue, tinnitus, GERD, esophageal spasms
50 2021-04-15 bell's palsy, facial paralysis 28 hours after 2nd Pfizer vaccine administered: First symptom was inability to suck from a straw. ... Read more
28 hours after 2nd Pfizer vaccine administered: First symptom was inability to suck from a straw. Lips could not be closed together on left side of mouth. Second symptom noticed was left eye not blinking or closing all the way compared to right eye. Third symptom was drooping smile on left side of face. We did not connect the timing of vaccine to this event until the following morning. It was Saturday morning and the symptoms still existing. We observed and monitored through the weekend and called the Doctor's office on Monday. The Doctor asked us to go to Emergency Room right away for possible stroke.
50 2021-04-15 breast pain, pain in extremity 24hrs after the second vaccine I had the usual reactions: fatigue, nausea, body aches. On the 2nd da... Read more
24hrs after the second vaccine I had the usual reactions: fatigue, nausea, body aches. On the 2nd day I woke up without any discomfort and was fine for 6-7 days. SEVEN DAYS AFTER THE 2ND VACCINE: Jabbing, throbbing pain, itching and "running ants" located in: hands, (knuckles, wrists, palms, both sides), forearms, armpits and under breasts, upper back between shoulder blades, upper ribs, thighs, behind knees, and bottoms of the feet. Ongoing, all over, both sides of the body going on now for 48hrs. I do not have any history of fibromyalgia. Constant urination. Difficult to sleep. Fatigue.
50 2021-04-15 feeling cold Left arm sore at injection site within five hours. I woke up with chills at 2am on 4/16/21 and kept... Read more
Left arm sore at injection site within five hours. I woke up with chills at 2am on 4/16/21 and kept waking up because I was so cold even though I had three blankets on me and the house thermostat was set to 75. I continued waking up from being so cold and started to have muscle aches in my buttocks, hamstring, and quads in the middle of the night. Got up at 8am on 4/16/21 and still have goosebumps/chills and aches in the above mentioned areas.
50 2021-04-15 feeling cold 50 y/o female, with no past medical history, who presents with itchy left arm, itchiness to differen... Read more
50 y/o female, with no past medical history, who presents with itchy left arm, itchiness to different areas of her body and mild dizziness post vaccination administration. Patient also states that her left arm feels cold. Patient states that she is allergic to Aspirin and NSAIDS. This is the patients first vaccination which was applied to the left deltoid. NP and Paramedics at patient side. Patients legs were elevated, vitals taken and all within normal limits (SPO2 99% RA, 71 HR, 103/54 BP, 12 Resp). Patient provided with bottle of water and Benadryl PO administered x1. Patient was observed by the NP for improvement of symptoms. Patient with resolution of symptoms within 20 mins of medication administration. Patient was discharged home in stable condition.
50 2021-04-15 fibromyalgia, pain in extremity Arm soreness Swollen lymphnodes under arms Fibromyalgoa like symptoms that wrap around my chest and... Read more
Arm soreness Swollen lymphnodes under arms Fibromyalgoa like symptoms that wrap around my chest and back.
50 2021-04-15 flushing, tingling tingling in legs and face-flushing-shortness of breath
50 2021-04-15 numbness, tingling Numbness, tingling on left side of face and finger tips. Evaluated by EMS-Cleared
50 2021-04-15 numbness, tingling When I have had a brain bleed, I have experienced tingling then numbness on the left side of my face... Read more
When I have had a brain bleed, I have experienced tingling then numbness on the left side of my face. I experienced that after the 2nd dose but it has stopped. I still have the numbness, but that does take some time to dissipate. I have spoken to my doctor and will have an MRI.
50 2021-04-15 pain in extremity, hypersensitivity of all senses, tenderness Patient received her first dose Of Covid19 9 Pfizer-Biontech) on 03/26/2021 at 05:27pm.It was admini... Read more
Patient received her first dose Of Covid19 9 Pfizer-Biontech) on 03/26/2021 at 05:27pm.It was administered on her left arm , deltoid area. Her temperature at the time of injection was 96F. She stated she didn't experience anything until 2 days after the vaccination. She felt a swelling under her left arm , closer to her left breast. it was tender to the touch and painful to the touch. She also experinced swelling of her extremities.She looked up the symptoms online and it was reported as a side effect to Covid vaccine ( pfizer ) The swelling subsided after 2 days. She felt okay otherwise. She returned today and received her second dose.advised her to make an appt with her doctor and request evaluation from a medical proffesional.
50 2021-04-15 pain in extremity, tingling Patient flinched and immediately complained of arm pain and then tingling in arm and fingers.
50 2021-04-15 pain in extremity First dose- barely had chills ( I am usually cold so this may not be a side effect except for the go... Read more
First dose- barely had chills ( I am usually cold so this may not be a side effect except for the goosebumps that came and went once or twice) and goosebumps for an hour in the evening and arm soreness for 24 hours. Second dose - barely had chills with goosebumps again for an hour or two in the evening in the evening and arm soreness for 24 hours. I typically have a body temperature of 97.4 and this evening it went to 98.1 for the hour or two. Had I not been monitoring due to the vaccine I would have chalked it up to tiredness or just cold as usual. The unexpected side effect which is why I am filling this form out was very bad dreams on both nights 4/9 and 4/10 and more than one bad dream on 4/9.
50 2021-04-15 tingling, numbness Arm swelling, numbness/tingling, stiff in joints
50 2021-04-15 tingling Bleeding from injection site, finger tingling (3-5) , shoulder and upper back pain, faint feeling..... Read more
Bleeding from injection site, finger tingling (3-5) , shoulder and upper back pain, faint feeling... Day 2 has been fever, body aches, chills. No relief from ibuprofen
50 2021-04-15 tingling Began to have itching , redness and tingling all over my body on April 9th, 2021 at 2:35 pm. Took 2... Read more
Began to have itching , redness and tingling all over my body on April 9th, 2021 at 2:35 pm. Took 25 mg of Benedryl to help with symtpoms on 4/9/21 at 4:00pm then again at on 4/10/21 at 12:00 am then again on 4/10/21 at 1:30 pm this did not help so I then took Zyrtec 10 mg on 4/11/21 at 10:00 am and this did not help. I then started taking a steroid Prednisone on April 12th at 11:30 pm 40mg, April 13th at 11:30pm 30mg, April 14th at 11:30 pm 20 mg and April 15th at 11:30 pm 10 mg. Today is April 16th and I am still feeling symptoms and am looking to make an appointment with an allergist, nuerologist and /or infectious disease dr.
50 2021-04-16 flushing headache, flushed feeling, cleared, pt. left site
50 2021-04-16 pain in extremity Rash/Hive on upper chest-used Cortisone cream and Claritin allergy pill Arm soreness & fluctuating l... Read more
Rash/Hive on upper chest-used Cortisone cream and Claritin allergy pill Arm soreness & fluctuating low grade fever used Tylenol and Advil topical muscle rub on arm
50 2021-04-16 seizure, migraine Syncope, collapse, seizure, amnesia, brain fog, migraine, nausea, vomiting, double vision; all ongoi... Read more
Syncope, collapse, seizure, amnesia, brain fog, migraine, nausea, vomiting, double vision; all ongoing since time of second dose administration
50 2021-04-16 tenderness Noticed of redness swelling hive-like area around 5 a.m. this morning. That area has grown in size o... Read more
Noticed of redness swelling hive-like area around 5 a.m. this morning. That area has grown in size over the day. It is warm to the touch. It does not see him in the last couple of hours that it is getting any larger. When I noticed it this morning it was also tender to the touch that remains but it has been tender since I got my injection on Wednesday. The tenderness has progressed in size as with the hive- like swelling. It's now about the size of a a small orange. Prior to this morning or late last night did not know this any redness or swelling . The previous tenderness to touch was approximately about the size of a quarter with a small bruise.
50 2021-04-16 tremor The following morning after receiving first vaccine began sudden onset high fever, severe shaking (c... Read more
The following morning after receiving first vaccine began sudden onset high fever, severe shaking (could not hold a cup of coffee), chills (could not get warm), and sudden fatigue onset. Slept for almost 36 hours with brief wakening and could not work and had no desire to eat.
50 2021-04-16 tremor The patient felt dizzy/ was shaking a couple minutes after receiving the Pfizer Covid-19 vaccine and... Read more
The patient felt dizzy/ was shaking a couple minutes after receiving the Pfizer Covid-19 vaccine and then passed out/ was unconcious for about 30 seconds, while still shaking and breathing. She regained consciousness, but still felt dizzy/ sweaty. Emergency services were called and evaluated the patient, who left under her own will.
50 2021-04-17 feeling hot Within a week, of getting the second dose, I have had the following symptoms: Fever of 101.8 Verti... Read more
Within a week, of getting the second dose, I have had the following symptoms: Fever of 101.8 Vertigo Bad Headache with nausea Throat tightening Chills and sweats My skin hurt to the touch, and all my joints felt like they were on fire.
50 2021-04-17 hot flush Swollen lymph node under arm are left side; hot flashes and teeth aching on left side
50 2021-04-17 pain in extremity Joint pain, fatigue, local pain in the arm, muscle pain
50 2021-04-17 tingling About 1.5-2 hours after receiving vaccine #1 patient felt light-headed. She noticed that skin on he... Read more
About 1.5-2 hours after receiving vaccine #1 patient felt light-headed. She noticed that skin on her arms, upper chest, face and eyelids turned red. She felt a tingling sensation over her skin as if she was going to get hives. She took diphenhydramine 25mg and Zyretec 10mg PO and drank lots of fluids. She also had a low grade fever upto 100F for a few days after the vaccine. She did not develop any hives or itching. The skin redness was gone the next day (3/23/21).
50 2021-04-17 tingling Brief episode of lightheadedness, less than 10 seconds, brief tingling in left arm . Treatment inclu... Read more
Brief episode of lightheadedness, less than 10 seconds, brief tingling in left arm . Treatment included vitals and observation, resolution of symptoms and discharged home.
50 2021-04-17 speech disorder, bell's palsy right sided facial paralysisBell's Palsy; dizzy; headache; feeling extreme fatigue; couldn't speak; ... Read more
right sided facial paralysisBell's Palsy; dizzy; headache; feeling extreme fatigue; couldn't speak; This is a spontaneous report from a contactable consumer (patient). The 50-years-old female patient (age at vaccination was 50 years old) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included kidney donor. The patient was healthy with no medical issues. Concomitant medication(s) was not reported. The patient experienced right sided facial paralysisbell's palsy, dizzy, headache, feeling extreme fatigue on an unspecified date. Reported as: Within 8 hours of receiving the dose, she said "the room got dizzy" and she developed a headache and Bell's Palsy. She states she had right sided facial paralysis, couldn't speak, and exhibited other stroke like symptoms. Was admitted to the hospital, given Plavix, and a headache "cocktail" to treat her symptoms. She underwent an MRI, CT, and echocardiogram to rule out a stroke. She is still hospitalized and states her symptoms started to resolve today, 02Apr2021, at around 8 AM. She also reports feeling extreme fatigue after receiving the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
50 2021-04-18 feeling cold I had chills, still do. I can't get warm. I stayed covered with clothes and a blanket all day Satur... Read more
I had chills, still do. I can't get warm. I stayed covered with clothes and a blanket all day Saturday and Sunday.
50 2021-04-18 numbness DVT in right leg; chest pain; PE in right lung was found on CT scan; numbness in both legs; Back pai... Read more
DVT in right leg; chest pain; PE in right lung was found on CT scan; numbness in both legs; Back pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 18Mar2021 13:30 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included breast cancer, hypothyroidism, diabetes. The patient did not have covid prior vaccination and no covid tested post vaccination. No known allergies. The patient was not pregnant. Concomitant medications in two weeks included metformin; atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID), vit d, multivitamin. No other vaccine in four weeks. Back pain started on 20Mar2021, chest and back pain on 24Mar2021 and chest pain continued until she went to the ER on 27Mar2021. When PE in right lung was found on CT scan on 23Mar2021 12:00 PM. The patient was hospitalized on 27Mar2021 and heparin was started and continued until 29Mar2021 when she was released. The DVT in right leg was found on 28Mar2021 with ultrasound after she mentioned numbness in both legs on 23Mar2021 12:00 PM. She started apixaban (ELIQUIS) on 29Mar2021 before leaving the hospital and still taking it now. She went to follow up appointment with hematologist that suggested that she remained on apixaban and return in 10 weeks for another checkup. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Number of days hospitalisation was 3. Treatment received for events included heparin and apixaban. The outcome of events was recovering. The patient received second dose of BNT162B2 in arm left on 09Apr2021 12:30 (Lot Number: EK8727).
50 2021-04-18 pain in extremity Got my first shot Pfizer on Friday the 16th at 1.40pm and in the eve around 7pm developed strong sto... Read more
Got my first shot Pfizer on Friday the 16th at 1.40pm and in the eve around 7pm developed strong stomach cramps in the lower region, feeling similar to a UTI. Urination is normal though. Now 2 days later the whole lower abdomen is swollen and painful with cramps. No nausea or vomitting, no chills , no fever, no itching. Just had arm soreness, a little sneezing wich was fine but the lower abdomen pain with pulling cramps is getting worse. The symptoms have not subsided yet.
50 2021-04-18 pain in extremity Patient received her 1st dose of Pfizer COVID vaccine on 02/26/2021. She noted some wheezing and sl... Read more
Patient received her 1st dose of Pfizer COVID vaccine on 02/26/2021. She noted some wheezing and slight shortness of breath and shared this information with her PCP at her regularly scheduled visit on 03/01/2021. PCP refilled inhaler at that time. Her shortness of breath progressively worsened, and she was seen by another provider as a walk-in at the office of her PCP on 03/13/2021. At that time, she was prescribed prednisone for 5 days, noting some improvement after a few days. She received her 2nd Pfizer COVID vaccine on 03/19/2021. The patient woke up on the morning of 03/20/21 with a swollen and painful leg and by 03/22/21 called PCP and was seen in the office. PCP ordered D-Dimer and LE ultrasound. Per the patient, the D-dimer was abnormal and the LE U/S showed a blood clot. PCP sent the patient to the ER, where a chest CT was ordered and showed a pulmonary emobolus. She was admitted overnight and started on Eliquis, and discharged the next day after seeing a hematologist.
50 2021-04-18 tingling paresthesia lateral foot, tightness left ankle, cough morning productive
50 2021-04-18 speech disorder, feeling hot, slurring, numbness, feeling cold Patient has been experiencing constant tiredness, dizziness, difficult and blur speech , face numbne... Read more
Patient has been experiencing constant tiredness, dizziness, difficult and blur speech , face numbness, and blurred vision a day after getting the vaccine. Patient also experienced hot and cold episodes that went away after taking Tylenol, but they came back when the medicine wore off.
50 2021-04-18 tremor, weakness Within 1 second of injection completion - hot pain seared down from injection site to wrist. 30-60 ... Read more
Within 1 second of injection completion - hot pain seared down from injection site to wrist. 30-60 seconds later while seated, roof of mouth and face began to tingle, throat felt extremely dry and itchy and intense thirst, a very strong surge of nausea, dizziness/vertigo, weakness of limbs- especially the hands. 60-120 seconds later body shaking, teeth chattering (but not from cold). 30-60 minutes later Mild headache. Allergic reaction symptoms came in waves of intensity for approximately 8-10 hours.
50 2021-04-19 burning sensation On April 18th around 12:15 I was scratching my right thigh, when I looked a notices some red bumps (... Read more
On April 18th around 12:15 I was scratching my right thigh, when I looked a notices some red bumps (rash). I stopped scratching it since I didn't want to irritate it. I then noticed the rash forming on my left thigh and eventually to my stomach. It looked like hives so I thought it may be an allergic reactions but I didn't know for sure. The back of both hands eventually started to feel warm and started to turn red and eventually showed what almost looked like welts. I again didn't scratch any of the rash and eventually in the evening they disappeared and there was not a trace of the bumps or redness. When I woke up on April 19th, I immediately checked to make sure the rash was gone and it was. As the morning progressed I noticed a burning sensation on the back of both my hands, both my legs and feet, stomach and the left and right side of my waste. I was concerned and immediately started checking online about the possible side effects of the vaccine. Both of my feet were so red that my toes looked almost blue/purple and both my legs were covered in red spots which looked almost like the measles or the shingles. I called my doctor to try and get an appointment but she didn't have anything available. By the end of the day, the rash was gone and again there was no trace that they were ever there except for the pictures that I took. On the morning of April 20th, I again checked to see if there was any sign of the rash and thankfully there was none. As the day progressed I noticed a burning sensation on both my elbows and forearm areas and there it was again. The rash was also on both of my knees but not as bad the the previous day. As the day progressed, the rash again disappeared without a trace. By evening I noticed my hands were irritated and I saw red bumps again but not as bad. I also noticed the bumps returned to both my knees and around my feet. This is very uncomfortable and I hope they finally go away for good but the fact that they keep coming back has me concerned since I am scheduled to receive my 2nd dose of Pfizer on April 27th and I'm not sure if I should get it since I don't want to aggravate my current rash.
50 2021-04-19 numbness I received my 1st vaccine shot on 04.09.21 at 4:05pm CST. Around 5:15pm CST, my lower extremities an... Read more
I received my 1st vaccine shot on 04.09.21 at 4:05pm CST. Around 5:15pm CST, my lower extremities and entire left side went numb. All feeling in my lower extremities returned by 11:00 pm CST. The facial and left arm/hand numbness remained with varying degrees of transient numbness. The numbness has ranged from 10% to 95% of feeling. I started doing research and determined my reaction was temporary and inflammatory and Bell Palsy like in nature. I missed work on 04.13.21 and notified my primary care physician, Dr by phone about the numbness. I was informed to go to the ER, especially if the numbness worsened. After taking Benadryl, by morning, the numbness remained transient, but subsided a bit. On 04.17.21, I started to feel a pull on my left eye muscle and a glare when I looked down. I notified my eye doctor, Dr I underwent an exam. My eye nerve was fine, however, my prescription in the left eye increased. As of today, 04.20.21, I am MUCH better, but the injection site remains little sore. The numbness remains transient in my left arm/hand, facial cheeks, and forehead with about 95% of feeling. My skin on my face (T-zones), also feels like sandpaper. I am making this report because I am apprehensive about receiving the 2nd shot.
50 2021-04-19 numbness and pain in extremities, tingling, numbness Loud ringing in both ears started around 5:00 pm the day of the vaccine. Gradually got better over ... Read more
Loud ringing in both ears started around 5:00 pm the day of the vaccine. Gradually got better over course of two weeks, but still experiencing ringing. Tingling/ numbness/neuropathy in right arm, right hand, right leg, right foot started day after the vaccine. Left arm, hand neuropathy, as well.
50 2021-04-19 pain in extremity Pain in the arm location where the shot was given with some pain radiating into my shoulder and neck... Read more
Pain in the arm location where the shot was given with some pain radiating into my shoulder and neck at times. Gets better and then pain returns and since the 2nd shot in the other arm where there was no reaction my right arm hurts again at the injection site and does not stop even taking pain reliever. I?ve also been sick with sinus aches, congestion, fever, chills, and cough that aches and sore throat on and off since the 2nd vaccination on March 31st. I feel this is lasting for a while and I?m so exhausted all the time. I don?t know if this has any relation to getting the vaccine but I?m never hardly ever sick and now I can?t go a day without pain or worse flu like symptoms.
50 2021-04-20 weakness, hot flush hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus... Read more
hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2, COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 13:45 (Batch/Lot Number: EN6204) as single dose for covid-19 immunization. Patient was not received any other vaccine in four weeks, Vitamin B12 received in two weeks. Concomitant medication included cyanocobalamin (VITAMIN B12). Patient was not pregnant. The patient experienced difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus, hot flashes, could not focus on 31Mar2021 13:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included allergies to shellfish (though allergy test says otherwise, wool, poison ivy, jewelry not identified why, heart rate fast on 31Mar2021. There was no covid prior vaccination, no covid tested post vaccination. Therapeutic measures were taken as a result of hot flashes, difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus. The events outcome were resolved with sequel. Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities. No follow-up attempts are needed. No further information is expected.
50 2021-04-20 numbness, weakness, sensory loss, tingling she had the prickly feeling like when her nerves were regenerating; feeling draining from my right a... Read more
she had the prickly feeling like when her nerves were regenerating; feeling draining from my right arm from the site of the shot downward to my finger tips/ I lost more and more feeling; numbness in my peripheral nerves/have not fully regained the feeling in my palm and fingers; trouble working due to the issues with typing and issues playing piano. Basic things like holding a cup and driving were an issue; could not get my arm to move and steer the car properly; weakness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number : ER2613) via an unspecified route of administration, administered on the right arm on 21Mar2021 10:30 at a single dose for COVID-19 immunization. Medical history included GBS (when I was 20 years old), Type 2 diabetes mellitus and high blood pressure related to type 2. Concomitant medications included rosuvastatin and metoprolol succinate. The patient previously took paracetamol (TYLENOL) and experienced allergies (anything with Tylenol). In less than 5 hours after the vaccine (21Mar2021 03:30 PM), patient started to feel the feeling draining from her right arm from the site of the shot downward to her finger tips. As each hour passed, she lost more and more feeling. She had complete numbness in her peripheral nerves for over 48 hours and have not fully regained the feeling in her palm and fingers. She had trouble working due to the issues with typing and issues playing piano. Basic things like holding a cup and driving were an issue and nearly caused an accident yesterday b/c she could not get her arm to move and steer the car properly. It has considerable weakness as well. The feeling between her right and left arm were distinctly different and it's really frightening. She was scared she won't get the feeling back in her right arm fully. From my elbow down was still a significant issue. Last 01Apr2021 she did have one incident where she had the prickly feeling like when her nerves were regenerating. The events resulted to a doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Outcome of the events was not recovered.
50 2021-04-20 migraine SEVERE MIGRAINE FOR 2 WEEKS WAS GIVEN TORADOL AND PROMETHAZINE
50 2021-04-20 muscle twitching Muscle twitches of posteriolateral chest wall on the side of vaccine administration
50 2021-04-20 tingling, weakness, numbness, numbness and pain in extremities, pain in extremity For 3 months patient having ongoing Left arm pain with neuropathy numbness tingling and also weaknes... Read more
For 3 months patient having ongoing Left arm pain with neuropathy numbness tingling and also weakness. She additionally has had no menstrual cycles since whereas had them regularly prior to shot.
50 2021-04-20 tingling, facial paralysis, numbness Feeling of overall not feeling well. Then I felt angry and scared at the same time. Bad heat around ... Read more
Feeling of overall not feeling well. Then I felt angry and scared at the same time. Bad heat around my heart. Then I started getting tingling down my left arm. Then heart palpatations. Then numbness in my left are and left side of my face with slight drooping on left side of face. I forgot to tell the nurse that my face felt numb on my left side. I had a mask on the entire time of my appointment.
50 2021-04-20 tingling, numbness Facial numbness and prickling for couple of minutes on4/1/21. Woke up with facial numbness on 4/2/21... Read more
Facial numbness and prickling for couple of minutes on4/1/21. Woke up with facial numbness on 4/2/21 and later in the day felt the roof of my mouth and portions of my tongue felt numb. Continued till 4/4/21 where in only my forehead and around my mouth felt numb and prickly. Then it has been on and off till date
50 2021-04-20 tingling After approximately 8 hours, initially very lethargic and expected left arm pain at injection site. ... Read more
After approximately 8 hours, initially very lethargic and expected left arm pain at injection site. A few hours later developed Severe headache, light headedness nearly fainting, motion sickness, mild cough, general fogginess, tingling of head (possibly nerves & related to severe headache ). Left arm pain & lethargy are not active.
50 2021-04-20 tingling Shingles. January 26th - Received first Pfizer vacccine at hospital February 8th - infusion of R... Read more
Shingles. January 26th - Received first Pfizer vacccine at hospital February 8th - infusion of Remicade 500 mg February 13th - skin started to get pins and needles and very painful February 15th - Received second Pfizer vaccine at hospital February 17th - Patches started appearing, extremely painful, went to dermatologist and was diagnosed with Shingles. February 18th - blisters started appearing on right side of face . Cheekbones, nose, under eye, cheek, upper lip
50 2021-04-21 burning sensation Rash appeared under left side of chin and upper part of neck within 3 hours of the vaccine shot. Con... Read more
Rash appeared under left side of chin and upper part of neck within 3 hours of the vaccine shot. Continued to itch and feel hot to touch where rash was. Before bed, abdomen felt very itchy. Next day.left side of chin and upper neck continued to be very itchy and both ears became itchy and burn. Then mid morning, rash spread to left side of face. Continued to be itchy and burn. Around 3pm, the rash spread to right side of face near jawline. I called my internal medicine doctor, sent photos of the rash. They advised me to go to the nearest Urgent Care Center immediately for a steroid injection. I went to Fast Med, was seen around 5pm. I was given a steroid injection on left hip and a Benadryl pill to help with itching. The rash looked like mosquito bites. I have photos I can share.
50 2021-04-21 feeling cold Flu-like symptoms (chills, body aches)
50 2021-04-21 numbness Chills, body aches, fever, headache, dizziness, numbness in face
50 2021-04-21 muscle spasms vertigo, muscle spasms, lightheadedness - lasted 2 weeks then resolved
50 2021-04-21 night sweats Severe runny eyes. Severely of runny noses I've ever had. Fatigue. Head pressure. Severe night sweat... Read more
Severe runny eyes. Severely of runny noses I've ever had. Fatigue. Head pressure. Severe night sweats that disappear and reappear quickly. Taste and hearing has decreased by 50%. Miserable.
50 2021-04-21 tingling 5 minutes after vaccination rapid heart beat and dizziness. Day after vaccination ran fever 100.4, h... Read more
5 minutes after vaccination rapid heart beat and dizziness. Day after vaccination ran fever 100.4, headache, dizziness, sore muscles and joints lasted 2 days. Headache and dizziness off and on for 14 days. Severe headache, tingling arms and hands on day 12. Stiff/sore neck on day 16.
50 2021-04-21 tingling -Mild tingling along left trigeminal nerve and left arm within 30 minutes. Still ongoing after 45 ho... Read more
-Mild tingling along left trigeminal nerve and left arm within 30 minutes. Still ongoing after 45 hours, but almost gone. -Mild headache starting within 3 hours and lasted less than 24 hours. -Trouble taking deep breaths starting around 10-15 minutes. O2 was 100 (even with asthma/pneumonia, my O2 is always above 92). I was otherwise breathing normally so I stayed calm and didn't need a rescue inhaler. The issue continued for about 30 hours. -Blood pressure spike. Although I was calm, I had a "weird" feeling starting within 5-10 minutes and my heart was speeding up. BP was checked around 20 minutes after injection. It was 168/106 with heart rate of 90. My usual BP is 120/68 with 62 heartrate. My BP has never been that high before as far as I know. Within another 30 minutes it was down to 145/94 and heart rate of 82, and I was released from observation to go home. I was seated and calm throughout episode. I felt "off" for several hours afterward, but had no way to check my BP. My heartrate averaged around 75-85 during that time. -Fatigue followed feeling "off" for another 30 hours.
50 2021-04-21 tremor, migraine *4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for h... Read more
*4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for hr and then got up, EXTREME pain in center of my left armpit (to point of almost crying and it was worse than my kidney stone pain I had for a week) and all over pain in body-hard to even move much this day...I slept in 12 hr increments till next day. Noticed my Heart rate was very high constantly between 100-115 ( on my wrist monitor) * On 4/5 Woke up and told myself to get moving for day, arm was turning very red at this point and swelling bad along with armpit along edge and was hot and still painful. Was up for 7 hr.. I got in shower that evening and felt weird midway and my head felt like a whoosh and thought I was going to pass out (normal temp in shower) held onto shower got out was fine for about 20 min and then I started extreme shaking uncontrollably and teeth were chattering from chills. Went to get a Tylenol because I knew something was not right and within 30 min started sweating profusely with fever (I didn't even get up because I felt so crappy) *4/6 Woke up, felt a little better, arm, armpit and side of armpit red, hot and swollen still. Was up for 9 hrs, but when I went to bed and laid down, I felt like I couldn't breathe well...something told me to take a deep breath and I felt something like a pop in chest and then I felt like I was breathing better. Was not still feeling good on 4/7 but went back to work, on 4/8 felt a lot better, then woke 4/9 with Migraine and felt terrible and my heart felt weird...I called the Health Department and asked what to do and they recommended going to doctor... but a Nurse followed up with me which was very nice. Went to doctor and my Blood Pressure was 179/98 at that time. They ran blood work and prescribed me a antibiotic for my arm and armpit area. I want to add as well, not sure if this matters, but my shot was not in center of arm...it was closer to inner part of upper shoulder closer to chest.
50 2021-04-21 tremor 10:40 am: Patient presents with palpitation and tremors. Vital signs: BP 166/95, HR 95, O2sat: 98% 1... Read more
10:40 am: Patient presents with palpitation and tremors. Vital signs: BP 166/95, HR 95, O2sat: 98% 10:50 am: Vital signs: BP 163/96, HR 90, O2sat: 96% 11:00 am: Vital signs: BP 165/98, HR 82, O2sat 98%
50 2021-04-22 weakness, numbness, muscle twitching Blurry vision/Nausea/Dizziness/Extreme Fatigue/Dry Mouth/Swollen Lymph nodes under injection arm/ wi... Read more
Blurry vision/Nausea/Dizziness/Extreme Fatigue/Dry Mouth/Swollen Lymph nodes under injection arm/ widespread body aches/eye twitch right eye/facial numbness/swollen hands/weakness(difficulty getting out of bed) Currently on day 5 and showing marked improvement in most areas. Still some fatigue/weakness, swollen hands, and eye twitch/facial numbness but much better than previous days. Never had fever or significant headache like many have reported.
50 2021-04-22 cold sweat, facial pain Dizziness, rolling pain throughout the body, cold sweats, fever, nausea for approximately 15 hours. ... Read more
Dizziness, rolling pain throughout the body, cold sweats, fever, nausea for approximately 15 hours. Approximately a few hours later that same day facial pain on the right side of the face became swollen around the eye and check. The swelling lasted approximately 30 hours before subsiding.
50 2021-04-22 feeling cold, pain in extremity Vaccine was given at 11am 4/10/2021. That day I had a slight headache, occasional dizziness, and a ... Read more
Vaccine was given at 11am 4/10/2021. That day I had a slight headache, occasional dizziness, and a sore arm. Then on Wednesday 4/21/2021 I woke up at 6am and couldn't function. I felt so extremely tired that I could barely move, had a pretty sever headache and chills. Thursday 4/22/2021 was the same: chills (couldn't get warm), severe headache, and extreme fatigue. Today, Friday the 23, I still have a slight headache, but the extreme fatigue and chills have gone away.
50 2021-04-22 pain in extremity Pain in both arms and shoulders, stiff neck, and back Exhaustion
50 2021-04-23 weakness One week after receiving the first shot I began experiencing dizziness and headaches and later weakn... Read more
One week after receiving the first shot I began experiencing dizziness and headaches and later weakness in legs that are not resolved with Ibuprofen and Tylenol or any other meds (Meclizine, Sudafed, Ipratromium Bromide nasal spray). The symptoms still persist and I am having more testing done to try to determine the cause. I have never experienced these symptoms persistently before.
50 2021-04-23 hot flush Hot flashes on and off for 3 days Feel faint during the hot flashes
50 2021-04-23 pain in extremity Severe headache, blurr vision, dizziness, lips were numb, 103.7 temperature, chills, body aches, arm... Read more
Severe headache, blurr vision, dizziness, lips were numb, 103.7 temperature, chills, body aches, arm life both sides sore, joint pain, nausea, hard to walk because headache was that bad.. This happened the next day on the 23 rd. Following the headache day before. Sought help at ER at 2:30 am on April 24th. Given iv fluid and norco and nausea med. For headache. As of 8:45 still have painful body aches chills and tiredness and arm pit pain.
50 2021-04-23 pain in extremity 100.1 fever at 2am. Received Pfiezer shot at 6pm the previous day. Also had a sore arm for about 2... Read more
100.1 fever at 2am. Received Pfiezer shot at 6pm the previous day. Also had a sore arm for about 24 hours. Pain when lifting the arm up to put on and off a shirt.
50 2021-04-23 pain in extremity 4/16/21 Second Dose received. 4/17 and 4/18 noticed light swelling in ankles. No other effects. 4... Read more
4/16/21 Second Dose received. 4/17 and 4/18 noticed light swelling in ankles. No other effects. 4/19 - Emailed my Cardiologist about swollen ankles. Didn?t think about the vaccine as a potential cause. He scheduled an Echocardiogram for May. 4/20 to 4/22 - Edema is ankles and lower legs with pain on bottom left. Tried heat and elevation with no relief. 4/23 - Called Advice Nurse with recommendation to go to ER. ER determined a blood clot in left leg at the left posterior tibial vein measured at 6.3cm.
50 2021-04-23 tenderness Approximately 6 hours post vaccination patient experienced spontaneous echymosis over ventral aspect... Read more
Approximately 6 hours post vaccination patient experienced spontaneous echymosis over ventral aspects of both hands---worse on thenar eminence. Slightly painful to touch. No other lesions noted and no other systemic symptoms with normal vital signs. Lesions began to resolve about 18 hours after vaccination but were faintly apparent at 24 hours post vaccination.
50 2021-04-24 cold sweat Black out briefly the day after the vaccine. Felt nauseous right after breakfast and then broke out... Read more
Black out briefly the day after the vaccine. Felt nauseous right after breakfast and then broke out in colds sweat and felt like I was going to pass out so I asked help to go lie down, next thing I know I was on the floor. Then had chills the whole day and fever of 101 later in the evening and weakness till date.
50 2021-04-24 numbness, burning sensation, tingling, feeling cold her right foot keeps falling asleep; feels like she was vibrating all over; burning of head from nec... Read more
her right foot keeps falling asleep; feels like she was vibrating all over; burning of head from neck up, felt like sunburn/ocasional burning or icing sensations throughout entire body; back of head felt like ice/ocasional burning or icing sensations throughout entire body/feels like ice was running through veins; tingling in head/paresthesia; jaw hurt; This is a spontaneous report from a contactable consumer reported for herself that a 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er8727) at the age of 50-years, via an unspecified route of administration in left arm on 24Mar2021 07:30 AM at single dose for COVID-19 immunization. Medical history included allergies to dust and mold. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No other medications the patient received within 2 weeks of vaccination. Patient reported that on 24Mar2021 10:00 AM (day 1), back of head felt like ice, tingling in head, jaw hurt; on 25Mar2021 (day 2), burning of head from neck up, felt like sunburn, back of head burned along with palms; day 3 and 4 - seemed better; day 5-8 - feels like ice was running through veins, feels like she was vibrating all over, ocasional burning or icing sensations throughout entire body. Patient also reported that received 1st dose of vaccine on 24 Mar2021. 15 days later she had paresthesia and her head was burning on the back. Also, the day her right foot keeps falling asleep. She would like to participate in any studies of side effects from this vaccine. She was concerned about receiving the second dose. No treatment received for the adverse events. Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
50 2021-04-24 numbness hearing is also coming and going periodically in both ears; I also felt like I was going to pass out... Read more
hearing is also coming and going periodically in both ears; I also felt like I was going to pass out about 5 minutes after the shot; Tinnitus in both ears started within about a half hour; I also have some facial numbness/tightness; I also have some facial numbness/tightness; intermittent ear pain; My joints in my feet and the bottom of my feet hurt.; ear fullness; very sensitive to sound; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021 at 10:15 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunisation. Medical history included Lyme disease from an unknown date. The patient has no known allergies. The patient is not pregnant. Concomitant medications included colecalciferol (VITAMIN D); probiotics; fish oil all taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 at 10:30 AM, the patient reported of tinnitus in both ears started within about a half hour of receiving first dose. The patient also felt like she was going to pass out about 5 minutes after the shot. The patient also has some facial numbness/tightness that started the same day as her shot (after the shot). The tinnitus, intermittent ear pain, ear fullness was reported as still continuing. The patient reported that her hearing is also coming and going periodically in both ears. The patient was also very sensitive to sound now. The patient's joints in her feet and the bottom of her feet hurt. Therapeutic measures were taken as a result of the events. Treatment of antihistamine and nasal spray was recommended. The patient do not have covid prior to vaccination and was not tested for covid post vaccination. The patient has not recovered from the events.
50 2021-04-24 migraine, pain in extremity, tingling high of 102 degree fever; Sever chills 1-4 am post vaccine; Woke up drenched several times; Muscles ... Read more
high of 102 degree fever; Sever chills 1-4 am post vaccine; Woke up drenched several times; Muscles felt like she's been shocked with high voltage; Tingling pain in bones and muscles; Tingling pain in bones and muscles; Tingling pain in bones and muscles; Lymph nodes in armpits and legs hurt; Lymph nodes in armpits and legs hurt; Headache approaching migraine; This is a spontaneous report from a contactable consumer (patient) reported that a 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration, administered in arm left on 03Apr2021 16:15 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. The vaccine was administered at the school or student health clinic. The patient medical history included occasional migraine headaches from allergies and hormones from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6204), administered in arm left on 13Mar2021 16:15 (at the age of 50-years-old) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. On 04Apr2021, the patient experienced sever chills 1-4 am post vaccine. High of 102 degree fever 3:00 pm following day (04Apr2021) until falling asleep around 9. On Apr2021, the patient woke up drenched several times. Muscles felt like she's been shocked with high voltage. Tingling pain in bones and muscles. Lymph nodes in armpits and legs hurt. Headache approaching migraine. No treatments were received for the events. The outcome of the events was recovering.
50 2021-04-24 muscle spasms Severe muscle cramps like extensor muscles locking up in back , arms & legs , severe nausea, blurred... Read more
Severe muscle cramps like extensor muscles locking up in back , arms & legs , severe nausea, blurred vision , light headness . With the 2nd shot the same again but add rash , increased BP ( high! ) . The pain in my muscles lasted 4 months ( 24/7) in my arms , legs & back, proprioception issues with my R leg , then it for the most part stopped and remained in my ankles & feet, and I feel like some cognitive issues . I still get waves of pain all over lasts for a couple of hours verses 24/7, I have a strange sensation constantly if my arms , legs & back .
50 2021-04-24 pain in extremity, weakness caller did not have a lot of energy; it is weird because she never sweats profusely; cough; could no... Read more
caller did not have a lot of energy; it is weird because she never sweats profusely; cough; could not catch her breath; splitting headache/headache that she could not even touch her head or hair; sick; fatigued/felt drained; sick to her stomach; arm started hurting; felt super heavy; could not move her body hardly to get up; This is a spontaneous report from a contactable consumer (patient). A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Left Arm on 31Mar2021 around 11:30 (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation. Medical history included sleep disorder from an unknown date and unknown if ongoing. The patient received first dose of BNT162B2 administered in left arm on 10Mar2021 at 12:45 (Lot number: EN6198) for COVID-19 immunization and Caller adds that she had no side effects after the first dose, nothing. Concomitant medication included zolpidem tartrate (AMBIEN) taken for sleep disorder, start and stop date were not reported. Patient take Ambien (NDC: 13668000810) at night time, she had been on it for years. The dose is 10 mg, she normally breaks it in half so she guesses 5 mg at night. It is just to sleep, since she does not sleep really well. Caller adds she also takes allergy shots but she did not get that until this week and she only does that once a month. No additional details of allergy shots. The patient experienced arm started hurting on 01Apr2021 02:00 with outcome of unknown, felt super heavy on 01Apr2021 02:00 with outcome of unknown, could not move her body hardly to get up on 01Apr2021 02:00 with outcome of unknown, sick to her stomach on 03Apr2021 with outcome of unknown, caller did not have a lot of energy on an unspecified date with outcome of unknown, splitting headache/headache that she could not even touch her head or hair on 05Apr2021 04:30 with outcome of unknown , sick on 05Apr2021 with outcome of unknown , it is weird because she never sweats profusely on 07Apr2021 with outcome of unknown , cough on 07Apr2021 with outcome of unknown , fatigued/felt drained on 05Apr2021 with outcome of unknown , could not catch her breath on 07Apr2021 with outcome of unknown. Therapeutic measures were taken as a result of headache and sick to her stomach. Clinical source: Caller was calling because she called her primary care physician and they said to call Pfizer. Caller took her second shot on the 31st and ever since she has taken that, every other day she has had some weird symptoms going on like this. She took her shot on Wednesday. Thursday at 2, all of a sudden her arm started hurting, she felt heavy, and could not move her body hardly to get up and go to the bathroom or whatever. Friday, she felt fine. Saturday she did not feel up to par. She was sick Saturday night. Sunday she was okay. Monday, she woke up with a headache that she could not even touch her head or hair. She then had to take some medicine because her head hurt so bad that it was making her sick. Today (07Apr2021), she got up and went and worked out and thought she could do workout class. Caller adds that it was weird because she never sweats profusely. She was drenched. Sweat was pouring off of her head and all over her body. She was fatigued again. She could not catch her breath, and she works out all the time. Caller's arm started hurting. Wednesday the 31st was her second shot at 11:30. Caller adds that her arm started hurting at 2 o'clock on 01APR2021. This went away. Along with this, caller felt super heavy if that makes sense at all and she could hardly move. Felt super heavy and could hardly move: caller adds that this was also at 2 o'clock on 01APR2021. This went away the next morning when she woke up. Friday she was okay. Friday caller was fine, and she felt good. Then Saturday night is when she was just sick to her stomach. Saturday night was when caller was just sick to her stomach. Whatever she ate that night, she got sick but she thinks it had something to do with the shot. The next morning, probably mid morning, caller started feeling better again. And then Sunday she was fine. She did not have a lot of energy but she was fine. Monday morning, she woke up probably around 4:30 am with a splitting headache. Caller adds that, like she said, she could not touch her hair. She took 800 mg Ibuprofen but it did not make her feel better. At 9 am, she took the Zofran because she was feeling sick to her stomach. Caller adds that she slept until 11. The headache subsided but the whole day she felt drained and could hardly move. Caller clarifies this was this past Monday, 05Apr2021. Tuesday, 06APR2021, caller was okay. Caller adds that she was pretty normal, and then today she woke up at 4:30am and thought since she had a good day yesterday that she was going to go back and workout and do her crossfit. She has been working out for three months. After her run, she was pouring sweat, which is not normal for her. Caller states that the sweating went away and just every once in a while she can not catch her breath and has kind of a little cough. Caller can not catch her breath and has a cough: caller adds it could be the pollen, she does not know. Caller then adds that she feels like she does not have energy today, normally when she does her workout she feels good the rest of the day if that makes sense. Caller adds that she wants to make sure this is normal. Caller states, like she said, she has been working from home since they sent her home back in March so she has not really been around a whole bunch of people and she has been really healthy. All of a sudden, she took the second shot and she is just not feeling the same. Caller states she wishes she would have known this, because she would have not taken the second shot if she knew this would linger this long. Caller adds that was everything. She just feels like she just does not have a lot of energy today (07Apr2021). Treatment included Ibuprofen, it was prescription Ibuprofen 800 mg. She just took it for her headache, she has not taken anything today (07Apr2021). She didn't take anything yesterday. None other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Family Medical History Relevant to AEs reported as none. No relevant tests. All events did not require a visit to Physician office or Emergency Room. No Follow-up attempts are needed. No further information expected.
50 2021-04-24 pain in extremity her right arm is aching in the shoulder and under her arm is sore; it feels like the muscle or somet... Read more
her right arm is aching in the shoulder and under her arm is sore; it feels like the muscle or something is hurting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration at the age of 50-year-old at arm right on 06Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated she received the first dose of the Pfizer COVID vaccine on 06Apr2021 in her right arm. The patient stated her right arm was aching in the shoulder and under her arm was sore in Apr2021. The patient would like to know if there was anything she can take for the pain. The patient would like to know if she can take extra strength Tylenol. Due to long hold, e-transmitting. Caller states okay to contact later for more information. The patient took a COVID shot 06Apr2021. Her arm was sore and it felt like the muscle or something was hurting in Apr2021. She was wondering what she can take for it. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
50 2021-04-24 sciatica Was in extreme body aches and my pain injection for my sciatica quit working. Could not do anything ... Read more
Was in extreme body aches and my pain injection for my sciatica quit working. Could not do anything was in bed that night starting at 6pm then all day the following day I could barely walk my whole entire body hurt as if I was in a terrible car accident. My sciatica was at a ten and to this day I have no relief from my injection when it comes to sciatic pain where before my second injection I was getting relief
50 2021-04-25 numbness, pain in extremity Sore right arm muscle tightness and numbing like my arm fell asleep from my elbow to my fingers and ... Read more
Sore right arm muscle tightness and numbing like my arm fell asleep from my elbow to my fingers and when I move my arm upward there is a pain shooting from the elbow to the shoulder. The numbness affect was 10 minutes after the shot it has continued for the next three weeks along with the pain when I move my arm up and down
50 2021-04-25 numbness First one was 45 mins after injection. - Numbness of the left side of my face. The next day was tir... Read more
First one was 45 mins after injection. - Numbness of the left side of my face. The next day was tired and slept most of the day. This was the same as my first shot. Tuesday, I woke up with a stomach ache. Thursday because it did not get better, I went to the emergency room and was diagnosed with pancreatitis. Was given the option to be hospitalized or go home. I went home. Followed up with Dr's office Monday. I see GI Doctor this Wednesday. Still cannot eat, nauseous and stomach hurts.
50 2021-04-25 nerve pain I developed shingles after the 2nd shot- burning nerve pain on my torso and slight rash
50 2021-04-26 numbness Numbness in left side of face/lips beginning 15-20min. after injection. Called health provider after... Read more
Numbness in left side of face/lips beginning 15-20min. after injection. Called health provider after an hour, who recommended taking an antihistamine. Took a 10mg antihistamine pill. The numbness subsided in about 30min.
50 2021-04-26 migraine A migraine that lasted for over 3 days. This migraine did not resolve with any of my standard migra... Read more
A migraine that lasted for over 3 days. This migraine did not resolve with any of my standard migraine protocols.
50 2021-04-26 muscle spasms I had the 1st Pfizer Covid 19 vaccine shot on Thursday 4/8/2021 at 6 pm. I started to feel pain radi... Read more
I had the 1st Pfizer Covid 19 vaccine shot on Thursday 4/8/2021 at 6 pm. I started to feel pain radiating up from my left arm (vaccination site) on Friday morning, 11 am. I have had muscle spasms and Malaysia in my shoulders and neck since that date. I saw my general physician yesterday, 04/26/2021. She said it was likely caused by the vaccination and advised me not to get the second vaccine.
50 2021-04-26 pain in extremity Patient was seen at hospital for leg pain and total body pain. Started on Thursday with total body a... Read more
Patient was seen at hospital for leg pain and total body pain. Started on Thursday with total body aches. Ruled out blood clots at ER. Was given Flexeril 10mg, Motrin, and APAP. Patient was seen at hospital on 4/26/2021 for leg pain and total body pain. Patient is unable to walk on her own. needed crutches to walk. Patient's pain has increased each day until today (4/27/2021)
50 2021-04-26 pain in extremity Lymphadenopathy and lymphatic cording limiting use of the arm and severe pain all the way to the wri... Read more
Lymphadenopathy and lymphatic cording limiting use of the arm and severe pain all the way to the wrist. Pain is constant, limiting sleep, and more severe with raising the arm above the head. Continuous pain three weeks after 1st shot.
50 2021-04-26 pain in extremity sore arm from injection time through 4/27, swelling near injection site, sore to the touch with redn... Read more
sore arm from injection time through 4/27, swelling near injection site, sore to the touch with redness
50 2021-04-26 pain in extremity Extreme chills, shivering, fever 102, itching at shot site, swollen arm, very tender and big swelli... Read more
Extreme chills, shivering, fever 102, itching at shot site, swollen arm, very tender and big swelling of lymph node in armpit.
50 2021-04-26 tingling Noticed ringing in my ear the second day following the 2nd dose. It has continued at the same level ... Read more
Noticed ringing in my ear the second day following the 2nd dose. It has continued at the same level since. Only notice when room quiet or I think about it. I also experienced arm pain at the injection site and was extremely tired for 3 days following both doses. I also had a few instances of dizziness that were mild and tingling in my hand fingers in the arm of the injection.
50 2021-04-27 discomfort All over body skin rash. Itching and discomfort Measle like Pityriasis rosea Still having the ras... Read more
All over body skin rash. Itching and discomfort Measle like Pityriasis rosea Still having the rash today 4/28/2021 Nothing helps.
50 2021-04-27 involuntary muscle movements, muscle twitching Started having muscle jerks all throughout the day. Also experienced muscle twitching. Went to a ... Read more
Started having muscle jerks all throughout the day. Also experienced muscle twitching. Went to a neurologist, had mri of brain, eeg of brain and blood work for brain tumor. All negative. Went a second time and the neurologist did more bloodwork for vit e, calcium, magnesium and vit d deficiencies. All negative. I am still to this day experiencing these issues.
50 2021-04-27 feeling cold, pain in extremity For the first 2 days, I only had a sore arm. Starting on day 3 after the vaccination, I started hav... Read more
For the first 2 days, I only had a sore arm. Starting on day 3 after the vaccination, I started having joint pain, chills, loss of appetite and headache. This continued for 3 straight days, but only at night. It went away for a few days, but returned and has continued, 2 weeks past my vaccination date. Symptoms remain predominantly at night and are bad joint pain, especially in hips in legs; chills and inability to get warm; headaches.
50 2021-04-27 numbness, tingling Almost immediately patient states she began experiencing tingling in her arm and hand. She remained... Read more
Almost immediately patient states she began experiencing tingling in her arm and hand. She remained at the pharmacy for approximately 30 minutes at which point she says her whole hand was numb. She was advised to seek medical help at that point. She went to the ER, was evaluated, and given ibuprofen. She was instructed to follow up with PCP.
50 2021-04-27 nerve pain, burning sensation Pfizer Covid vaccine: 1st dose gotten 12-22-20, had some expected side effects but didn't do anythin... Read more
Pfizer Covid vaccine: 1st dose gotten 12-22-20, had some expected side effects but didn't do anything about it then. However, within 2 weeks, reactivation of my shingles neuralgia and zoster on my lip that has persisted for 4 MONTHS now. This is not normal for me, although at times I would get a sore on my lip or feel burning on my right flank (for a day or 2) every few years or so. This continual burning pain and zoster sores on different areas of my lips is very unusual and getting a sore after sore after sore each week or two is getting rather ridiculous. Normally a sore would last a week or so and be gone for long periods of time. I have no serious other medical conditions. Nothing else has changed: sleep, diet, stress, etc. I feel this is completely related to the vaccine. I did not get the 2nd dose.
50 2021-04-27 nerve pain In the evening after the vaccine was administered, I experienced pain at the injection site, the fol... Read more
In the evening after the vaccine was administered, I experienced pain at the injection site, the following morning I had more pain at the injection site, moderate to high fatigue (2 days), and later in the day I experienced nerve "pings" in my elbow and fingers and a rash (neck and chest) on the same side of my body as the injection (Right side). Occasional nerve pings continued and expanded to my right knee and foot at various sporadic times as well as a couple episodes of coughing. Today 4/28/21, I noticed mild shortness of breath in the morning, while fatigue is lessening somewhat. I am concerned about getting a 2nd vaccine based on my reaction to the first one. What is the advice on this?
50 2021-04-27 pain in extremity I received my second shot on April 17th, 2021. I injured my foot on April 21, 2021. I went to my G... Read more
I received my second shot on April 17th, 2021. I injured my foot on April 21, 2021. I went to my General Physician the following day and received a tetanus shot. Up until that time, my side effects were very light; slight headache, arm muscle pain. Two days after receiving my tetanus shot I could barely get out of bed. I woke up feeling as if someone had drugged me; my mind was very fuzzy and it was hard to focus. Every muscle in my body was in extreme pain and it hurt to breathe. I had bouts of terrible stomach cramps. I felt nauseous to the point that I was unable to eat solid food other than chicken soup and crackers for three days. I do fully believe my side effects happened because of the tetanus shot as I had very little side effects before the shot. I felt like I was dying. Luckily I had some medicine at home that helped with the symptoms; gabapentin for my shoulder injury, zofran from a past hospital visit, and I took tylenol. I am a Medical Assistant and didn't feel the hospital or the Dr. office could have offered me any relief from my symptoms.
50 2021-04-27 tension headache Shortly after receiving 2nd dose, client started to experience a constant and severe headache accomp... Read more
Shortly after receiving 2nd dose, client started to experience a constant and severe headache accompanied with a swollen face. Client has seen her PCP and was given a shot for tension headaches - did not relieve pain. Client went to ER 4/27/2021 and was treated with pain shots - little relief from pain. Client is still experiencing headaches and swelling. Client has an upcoming appointment with a neurologist in May.
50 2021-04-27 tremor, pain in extremity, weakness, tingling Was menstruating at time of second shot, but near end of bleeding stage Within 4 hours of second sh... Read more
Was menstruating at time of second shot, but near end of bleeding stage Within 4 hours of second shot: pain in vaccine arm (right arm), veins at wrist of vaccine arm (right arm) also began hurting/throbbing; off and on pins and needles feeling in thighs; began feeling strange -- just feeling that things were happening inside my body; headache when playing with child Within 16 hours of second shot: feeling of malaise, sadness, lethargy, lack of appetite, extreme thirst. Redness at vaccination entry site (had this after first shot as well) Within 20 hours of second shot: feeling of malaise, sadness/crying, lethargy, really tired, lack of appetite, extreme thirst, very very cold extremities (especially fingers), chills, body aches, weakness, nausea, low grade fever, pain in vaccine arm, several hours of alternating shaking chills and sweats Fever broke and chills, sweats, nausea subsided by 26 hour mark since second shot. Lack of appetite, weakness, tiredness continued. 40 hours post second shot: all major symptoms subsided, except feeling of apathy, lack of energy By 48 hours post second shot feeling mostly better. 5 days post second shot: STILL BLEEDING FROM PERIOD!!! Unheard of. Never had something like this happen. Also had blinding, excruciating, utterly debilitating pain in vaccine arm upon waking from overnight sleep. The most horrible pain; was sobbing with the pain. Could not lift arm, intense muscle pain in upper arm on vaccine arm (right arm). Mostly subsided after about an hour of massaging, but still have dull pain and do not have full range of motion 2+ hours later.
50 2021-04-27 tremor, slow speech, muscle spasms A few days after shot 4/27/21- went to ER hospital, with leg, body spasms, could barely talk, shakin... Read more
A few days after shot 4/27/21- went to ER hospital, with leg, body spasms, could barely talk, shaking uncontrollable - just awful never saw anything like it before. They did blood test and cat scan of head and couldn't find anything so referred her to neurologist -- waiting to get appt. We forgot to tell them that she had 2nd cover shot on the 22. Didn't even think of that then. They would not admit her. I had to take her home shaking but they did give her some divan at hospital which helped some.
50 2021-04-28 flushing Anaphylaxis. 36 hours after 2nd vaccination. Closing of of chest muscles, lungs, esophageal tract up... Read more
Anaphylaxis. 36 hours after 2nd vaccination. Closing of of chest muscles, lungs, esophageal tract up to back of throat. Resting heart rate of 133 BPM at triage in ER. Severe coughing which caused vomiting. Slight pink flushing of nose and cheekbones 30 minutes after shot, after leaving vaccination site, with no adverse reaction.
50 2021-04-28 numbness Rapid heart beat-lasted 9 days, increased blood pressure meds until it got better shortness of breat... Read more
Rapid heart beat-lasted 9 days, increased blood pressure meds until it got better shortness of breath-lasted 2 weeks-used inhaler muscle pain-hasn't went away knee pain and swelling-hasn't went away numbness in right leg-2weeks
50 2021-04-28 numbness Pt presents for possible reaction after first COVID vaccine. She developed hive, tongue swelling, an... Read more
Pt presents for possible reaction after first COVID vaccine. She developed hive, tongue swelling, and numbness to face. 50-year-old female with history of having a Guyon Barré type syndrome after flu vaccine who had her initial Covid vaccination today, she was given the Pfizer vaccine and approximately 5 hours later began developing hives on the left side of her neck and left tongue numbness. Patient denies headache, no trouble swallowing, no shortness of breath. She denies any chest pain. Patient has no numbness or tingling in her arms or legs. She did take 50 mg of Benadryl prior to my evaluation with minimal improvement of symptoms.
50 2021-04-28 muscle spasms POST VACCINE, C/O CRAMPING IN LEGS AND ARMS, REPORTS DID NOT EAT OR DRINK WATER ALL DAY, GIVEN COLD ... Read more
POST VACCINE, C/O CRAMPING IN LEGS AND ARMS, REPORTS DID NOT EAT OR DRINK WATER ALL DAY, GIVEN COLD WATER AND CRACKERS. VSS. ESCORTED TO EXIT WITH NO ISSUES ONCE S/S RESOLVED AT 1530. 1519 BP 119/81 HR 81 SATS 97% RA 1529 STANDING BP 119/81 HR 83 SATS 97% RA
50 2021-04-28 tingling 9-10 hours after 1st dose my left arm tingled like it was asleep. Then my hands and feet started tin... Read more
9-10 hours after 1st dose my left arm tingled like it was asleep. Then my hands and feet started tingling as well. My arm tingling stopped after a few minutes but I have tingling in my fee quite often. 12 hours after 2nd dose I got a fever, 17 hours after I threw up and had a the worst headache, 21 hours after I still had a fever headache nausea and I passed out. I started to feel a little better 30 hours after my 2nd dose, but was sluggish for another 2 days. Then 2 days after the tingling in my feet came back and is almost constant.
50 2021-04-29 weakness Fever, chills, nauseous, weak
50 2021-04-29 flushing Patient began with symptoms of feeling flushed within l minutes of receiving the vaccine. she compl... Read more
Patient began with symptoms of feeling flushed within l minutes of receiving the vaccine. she complained of feeling shaky and was evaluated by EMS. She was monitored for more than 30 minutes including BP which ranged from Systolic 183-202 and diastolic 109-121. Her HR ranged from 110-130. her symptoms did not resolve and seemed to intensify. she was transferred to the hospital for further evaluation.
50 2021-04-30 feeling of body temperature change Strong metal taste in mouth - subsided after a day (no treatment) Nausea - subsided after a day (no ... Read more
Strong metal taste in mouth - subsided after a day (no treatment) Nausea - subsided after a day (no treatment) Severe headache - took Target Up&Up extra strength headache relief after 24 hours. Headache lasted 3 days. (until Thursday) Body aches / joint pain - subsided after 2 days (Monday - Wednesday) Feeling hot and code - subsided after 2 days (Monday - Wednesday)
50 2021-04-30 hypersensitivity of all senses, pain in extremity Chills, skin sensitive to the touch, sharp pains here and there, stiff neck and tired on Friday. La... Read more
Chills, skin sensitive to the touch, sharp pains here and there, stiff neck and tired on Friday. Late Friday night chills again low grade fever, sensitive to touch and swelling in one finger and sharp pains in legs and body. Weird feeling at times.
50 2021-04-30 migraine, pain in extremity, burning sensation A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased i... Read more
A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased in swelling and burning pain; severe swelling and burning sensation; severe swelling and burning sensation; Leg increased in swelling and burning pain; Phlebitis; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199/EN5318), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 12Mar2021 15:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not COVID tested post vaccination. The patient had no other vaccines in four weeks. Medical history included high blood pressure and sleep apnea. Concomitant medications included amoxicillin, valsartan, amlodipine, and vitamin d [vitamin d nos]. The patient previously took doxycycline and experienced allergies. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On 05Apr2021 at 03:00 PM, the patient experienced a blood clot was found, cellulitis, migraine started within 24 hours, left calf pain/leg increased in swelling and burning pain, severe swelling and burning sensation, leg increased in swelling and burning pain, and phlebitis. It was further reported that migraine started within 24 hours. 48 hour left calf pain that got increasingly worse leading to a severe swelling and burning sensation. The patient went to right time urgent care on Friday, 09Apr2021. The patient was diagnosed with cellulitis. It was also reported that pain increased swelling spread and went to emergency room (ER) on 10Apr2021 for ultrasound of leg. No clots and was advised if worsened to come back. The patient's leg increased in swelling and burning pain. The patient went to urgent care patient first on 11Apr2021 and then the doctor on Monday, 12Apr2021 where she was sent for a STAT ultrasound due to major pain and swelling. A blood clot was found. Phlebitis was diagnosis. The patient was sent to a vascular surgeon on 13Apr2021 and vein specialist on 15Apr2021. The patient was given Xarelto blood thinners and started taking them on 15Apr2021. All of this began 48 hours after taking the second vaccination (pending clarification) and has the patient worried. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.
50 2021-04-30 pain in extremity Fever; Chills; Malaise; Fatigue; Arm Pain; This is a spontaneous report from a contactable consumer ... Read more
Fever; Chills; Malaise; Fatigue; Arm Pain; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161, expiration date not reported) via unspecified route of administration in Arm Left on 14Apr2021 10:30 (age at vaccination 50-years-old) as single dose for covid-19 immunisation. Facility where most recent COVID-19 vaccine was administered was other. Medical history included chronic diverticulitis, drug hypersensitivity to penicillin, augmentin, erythromycin and lactose intolerance. Concomitant medications in two weeks included loratadine, pseudoephedrine sulfate (CLARITIN-D) taken for hypersensitivity from an unknown date. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 24Mar2021 at 09:00 AM, (at the age of 50-years-old) as a single dose for COVID-19 immunization. Patient did not have or was diagnosed for COVID prior to vaccination. Patient was not tested for COVID post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021 20:30 the patient experienced fever, chills, malaise, fatigue and arm pain. The patient received acetaminophen as treatment for the adverse events. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.
50 2021-05-01 inability to speak Anomic aphasia
50 2021-05-01 flushing, cold sweat Patient reported to the pharmacy for dose 2 of her of Pfizer Covid vaccine, she reported symptoms of... Read more
Patient reported to the pharmacy for dose 2 of her of Pfizer Covid vaccine, she reported symptoms of throat constriction, malaise, cranial pressure and generalized itching. Patient appeared clammy, flushed, and confused. Patient was given 2 doses of Epi over 10-15 minutes and EMS was called but she refused transport to hospital due to financial issues.
50 2021-05-01 muscle spasms, tremor, tingling Pt received vaccine, and 15 minutes lately complained of cramps in her torso area. Shortly after r... Read more
Pt received vaccine, and 15 minutes lately complained of cramps in her torso area. Shortly after reported a bit light headed. We had her lie down with legs elevated. This did not appear to help. Shortly after still complaining of cramping was given 1 tablet of 500 mg acetaminophen. Breathing appeared normal. Shortly after complained of tingling all over. 911 was called . Then she complained of stiffening of her jaws. An epipen was administered at this time and pt appeared to be doing better even though shaking at this time, posssibly from epipen. Shortly after emergency personnel arrived and tool over. She was transported to the hospital. On a follow up phone call a couple of hours later she stated she was stable but the dr's hadn't given resolution of what happened.
50 2021-05-02 muscle spasms, pain in extremity Severe headache on 4/22 and 4/23. But the most traumatic side effect (that may or may not have been ... Read more
Severe headache on 4/22 and 4/23. But the most traumatic side effect (that may or may not have been caused by the vaccine) was extremely heavy period bleeding. There was no bleeding, then a rush of blood running down my legs. It was quite heavy for a hour or so. Still bleeding heavily later in the day but not excessive. Cramps and leg pain as well. I am 50. My period symptoms vary quite a bit these days, but I have never had bleeding like this in my life.
50 2021-05-02 pain in extremity, discomfort Sore arm began a few hours after receiving shot and lasted for 2 days. On day 2, began experiencing ... Read more
Sore arm began a few hours after receiving shot and lasted for 2 days. On day 2, began experiencing swollen tongue and metallic taste; these lasted for 1 day. On day 3, began having difficulty concentrating / thinking clearly, experiencing anxiety, general sense of bodily discomfort, uneasiness. This lasted 2 days. On day 6, experienced an ocular migraine. No treatment was given, no further symptoms to date.
50 2021-05-03 weakness Fever day 1 101.5; Fever day 2 99.5; chills, weakness, fatigue
50 2021-05-03 burning sensation, feeling hot, numbness, tremor fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation do... Read more
fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.
50 2021-05-03 burning sensation, tingling heart attack; tingling down left arm/tingling down right arm /tingling down left leg/tingling across... Read more
heart attack; tingling down left arm/tingling down right arm /tingling down left leg/tingling across back/tingling down right leg; burning sensation in her shoulder blade; muscle pain; muscle tightening; aching to left shoulder; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FR8732, on 05Apr2021 at single dose in left arm for COVID-19 immunisation. Medical history included blood clot in lung from 26Mar2021 (according to the chest X-ray she did not still have it but she had not been to her pulmonologist yet), complete hysterectomy in Jan2021, liver condition, high cholesterol and blood clot. Concomitant medications included apixaban (ELIQUIS) for blood clot, ursodiol for liver condition, and pravastatin for high cholesterol. The patient had the first dose on 05Apr2021. She began feeling muscle pain and a burning sensation in her shoulder blade the Thursday after receiving the vaccine (08Apr2021) and into Friday (09Apr2021). She had muscle tightening and aching in her left shoulder on 08Apr2021. By Monday mid morning (12Apr2021) she had tingling all down her left arm, across her back, down her right arm and into both legs. She began having tingling in her arms and legs bilaterally since last Monday (12Apr2021), however it was more prominent in her left extremities rather than the right. She wanted to know if this was a side effect of vaccine. She got the shot in her left arm. She went to the hospital and they admitted her. She had tests in the ER. She had MRIs, CTs and a battery of blood tests. They could only tell her what it was not and not what it was. It was not cancer, stroke, heart attack, aneurysm or a brain tumor. She was released and did not know what caused it. Again from the above that on Thursday (08Apr2021) her left shoulder muscle started aching and on Monday a week later she experienced tingling. She thought she was having a heart attack and was hospitalized for 4 days. She asked the doctor if this was a side effect and she was told to call the place where the vaccine was administered. She called the nurse and she could not give answers and recommended that she call Pfizer. Several conditions were ruled out but she was not given a reason for her symptoms. Her HCP has not been helpful. She stated she had a complete hysterectomy in January but doesn't think that would have any effect. She had a CT on 12Apr2021, a MRI of her head and neck on 12Apr2021, a MRI with contrast on 14Apr2021 of her upper neck, a MRI of her lower back on 15Apr2021 and a bone scan on 15Apr2021. Stated that they all came back normal no abnormalities. The outcome of muscle tightening was resolving. The outcome of heart attack was unknown. The outcome of other events was not resolved.
50 2021-05-03 numbness, tingling Patient presented to ER on 4/12/21 with after developing a numbness/tingling sensation in both of he... Read more
Patient presented to ER on 4/12/21 with after developing a numbness/tingling sensation in both of her shoulders that radiated down both of her arms. Patient then developed tingling in both of her lower extremities. MRI demonstrated a non-specific C7 lesion and neurosurgery was consulted who did not recommend any intervention. Ultimately the patient was discharged on 4/15/21 with no definitive diagnosis or rationale for the numbness and patient wondered if it could be related to the vaccine. Patient is scheduled to follow up with outpatient neurology.
50 2021-05-03 numbness Severe numbness and tingling in both arms, both legs, hands and feet. It was very creepy. Shortness ... Read more
Severe numbness and tingling in both arms, both legs, hands and feet. It was very creepy. Shortness of breath intense for about an hour. Armpit very sore on left side where I got the dose.
50 2021-05-03 migraine Since One month after receiving 1st dose of vaccine, monthly periods are erratic and I've never fluc... Read more
Since One month after receiving 1st dose of vaccine, monthly periods are erratic and I've never fluctuated. I have more cramping than have experienced in the past, and reg monthly weeklong migraines have decreased in severity and length. HOWEVER, I am at that age, could it be menopause starting??
50 2021-05-03 nerve pain, hypersensitivity of all senses Shingles outbreak on thigh, extreme skin sensitivity x 1 week, followed by severe nerve pain and shi... Read more
Shingles outbreak on thigh, extreme skin sensitivity x 1 week, followed by severe nerve pain and shingles rash, still under treatment with ibuprofen and valacyclovir
50 2021-05-03 pain in extremity, weakness Patient having severe right arm pain where shot was given 4 weeks ago. Day of vaccine, had dilated ... Read more
Patient having severe right arm pain where shot was given 4 weeks ago. Day of vaccine, had dilated pupils, neck rash. Next day, severe right arm pain, shoulder pain, neck pain, all on the side that vaccine was given, vomiting, weakness, swollen glands.
50 2021-05-03 tingling, burning sensation Pins and needles in face and extremities, burning hands and feet Paresthesias
50 2021-05-03 tingling, tremor, numbness and pain in extremities, numbness, weakness Pfizer-BioNTech COVID-19 Vaccine EUA: nine and eleven days after vaccination during clinic visit pat... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: nine and eleven days after vaccination during clinic visit patient reports left axillary swelling radiating down left arm. Subsequently developed numbness and tingling to left hand/fingers seven days after vaccination. Arthralgias, joint swelling, mylagias, and weakness also noted. After first visit patient prescribed methylprednisolone. Two days later patient returned to clinic with improvement in swelling but reports tremors and three new bumps on arm, palpitations, and weakness/numbness of 4th and 5th digits on left hand proximally. Patient referred to neurology and physical therapy with diagnosis of ulnar neuropathy.
50 2021-05-04 muscle spasms Approximately 24 hours after the second shot I noticed moderate neck pain on the left side around th... Read more
Approximately 24 hours after the second shot I noticed moderate neck pain on the left side around the collar bone. Upon self examination the area the lymph node in that area was significantly swollen, painful to the touch and squishy which is to say I did not hard. The skin in the area was red. I had several other symptoms that are being commonly reported. The symptoms listed below started to occur at approximately 4 hours after the second shot. These symptoms lasted for approximately 18 hours after the shot was administered. Headache, stomach ache, muscle cramps, fatigue, chills, overall body aches and dizziness. I contacted my doctor four days after regarding the lymph node concerns as the swelling was still a concern. I was seen the same day and advised to report back if the swelling did not go down. I am reporting this two days after my doctor's visit. The swelling is continuing to go down. The area is still somewhat painful when gently rubbed. The skin in the area is no longer red. I checked the box as not having recovered because the swelling has not completely gone away as of the time of this report.
50 2021-05-04 pain in extremity, night sweats Left arm soreness, fatigue, headache all began same day. Migraine, joint stiffness (elbows, hips, an... Read more
Left arm soreness, fatigue, headache all began same day. Migraine, joint stiffness (elbows, hips, ankles), nose bleed, left armpit pain, fever, chills, night sweats began next day (5.4.21) and continued to 5.5.21. Adverse effects ongoing.
50 2021-05-04 tingling Pfizer-BioNTech COVID-19 Vaccine EUA I have experienced pain and tingling in my left arm, where I w... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I have experienced pain and tingling in my left arm, where I was injected with the vaccine, since the night (early next morning) I received the vaccination. The pain and tingling runs from right below the point of injection down through my forearm. Just within the last few days (3-5 day) I am experiencing tingling in my hand/fingers.
50 2021-05-04 tension headache pressure in her head; Tension headache; neck ache; muscle ache; Back ache; I guess my headache is du... Read more
pressure in her head; Tension headache; neck ache; muscle ache; Back ache; I guess my headache is due to the muscles being inflamed from the vaccine, this is on my scalp, my neck and then my shoulder; This is a spontaneous report from a contactable physician reporting for herself. This 50 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283) on 21Jan2021, for COVID-19 immunization. Medical history and concomitant medications were none. On 21Jan2021, within a minute of having vaccine, the patient had pressure in her head and got a headache. It was since 17 days and she had still not fully recovered. The headache had subsided but she had neck ache, muscle ache and back ache. She guessed her headache was due to the muscles being inflamed from the vaccine, this was on her scalp, her neck and then her shoulder. She went to her primary care doctor and he said she had tension headache and this all happened on the same side of the vaccine. The events required treatment with Aleve, Motrin and Tylenol. She had still to get the second shot and was wondering if she should wait until fully recovered. The patient had not yet recovered. Information on the lot/batch number has been requested.
50 2021-05-05 weakness C/c of feeling dizziness/weakness after receiving her 2nd vaccine. Pt has Hx of Anxiety and takes pr... Read more
C/c of feeling dizziness/weakness after receiving her 2nd vaccine. Pt has Hx of Anxiety and takes prescribed Valium. V/S stable: BP: 120/78, HR: 78, SPO2: 98%RA. Pt stated that she did not want emergency called and did not want to go to the hospital. Pt advised that taking an Uber was not recommended and emergency service would be called and that she is able to refuse transport thru emergency. They were called and arrived at 10:40. Pt was assessed and refused transport. Pt signed Incident Report stating that she was refusing emergency transport and that she was claiming responsibility of being transported home via Uber.
50 2021-05-05 hot flush Constant pain in left wrist. Wore a brace for a few days but the pain is still consistent. Major in... Read more
Constant pain in left wrist. Wore a brace for a few days but the pain is still consistent. Major increase in daily hot flashes. At the minimum, 3-5 during the course of the night and several during the day.
50 2021-05-06 difficulty speaking Hoarseness within a week of 1st Pzifer-BioNTech SARS-CoV-2, intermittent 1st dose on 1/6/21 2nd dos... Read more
Hoarseness within a week of 1st Pzifer-BioNTech SARS-CoV-2, intermittent 1st dose on 1/6/21 2nd dose on 1/27/21 Hoarseness now occurring daily starting 5/5/21
50 2021-05-06 feeling cold 3/30/2021, the day of vaccination, patient experienced fever and arm tenderness. Evening, the next d... Read more
3/30/2021, the day of vaccination, patient experienced fever and arm tenderness. Evening, the next day, 3/31, patient had chills and felt "cold inside". She has continued to feel cold inside for next 3 weeks. Has also experienced fatigue, nausea, and headache off and on. Follows a pattern of being worse overnight and in the morning, and then feeling okay by evening, and then repeats the next day. On 4/20 her physician advised her to wait to receive the second dose until she felt better. Her next doctor appt is June 3. On 4/23 she felt almost normal but still felt a bit cold inside with slight headache. On 5/7 she feels almost completely normal with a slight coldness by her eyebrows each night. She feels well enough now to come for her second vaccine dose next week.
50 2021-05-06 migraine Fever, chills, body aches, migraine, nausea,
50 2021-05-06 muscle spasms Menstrual cycle was longer than usual (39 days vs 26-28 days), the duration of menstruation was doub... Read more
Menstrual cycle was longer than usual (39 days vs 26-28 days), the duration of menstruation was doubled and was heavy, experienced headaches and cramps for 4 days, experienced tightness in muscles especially in abdomen and legs for 3 days, both feet were noticably swollen for 2 days. Normally no cramps and never have headaches.
50 2021-05-06 muscle twitching, pain in extremity Soreness on the right underarm and on the side of the right breast of the arm that that vaccine was ... Read more
Soreness on the right underarm and on the side of the right breast of the arm that that vaccine was administered. Soreness last 5 days and the soreness subsided on 5/7/2021. Twitching in the right eye for 5 days. The twitching started on Sunday. Two days after the vaccine. The twitching stopped on 5/7/2021.
50 2021-05-06 pain in extremity first 2 days, normal side effects (sore arm, fatigue) then day 3 dizziness and nausea all day and st... Read more
first 2 days, normal side effects (sore arm, fatigue) then day 3 dizziness and nausea all day and still happening after 15 days. has not gone away yet
50 2021-05-06 pain in extremity I had some adverse effects immediately after the 1st dose. I felt"sped up" and hyper and then got an... Read more
I had some adverse effects immediately after the 1st dose. I felt"sped up" and hyper and then got an almost"drunk" feeling. It lasted for 7 hours, then stopped, but I had general fatigue for 5 days, aches/pains. After the 2nd shot, I had similar reactions for 2 days, then I felt ok. 3 weeks later, though, I woke up to immense joint pain, lower leg pain, huge amount of fatigue and pain. The lower limb and joint pain was incredibly intense and pretty horrible. I still have pain in one leg currently. It's pretty severe and painful!
50 2021-05-07 weakness 1st Pfizer Covid vaccination on April 1, 2021 Morning of April 2 she woke up with severe lower extre... Read more
1st Pfizer Covid vaccination on April 1, 2021 Morning of April 2 she woke up with severe lower extremity spasticity and the inability to mobilize. Presented to hospital April 3rd. Started high-dose intravenous Solu-Medrol on hospital day 3 and it was not until hospital day 4 that we begin to see improvement of her spasticity and ability to move her legs Felt to be acute myositis, most likely an immune mediated post vaccination event Received 1000 mg IV Solu-Medrol x5 days Course complicated by bilateral pulmonary embolisms in setting of severe spasticity and immobility Hospitalized 4/3/21-4/13/21 Discharged to rehab, on day of discharge requiring maximal assist to stand and for transfers
50 2021-05-07 difficulty speaking Cough, Sinus pain, Rhinorrhea, Post Nasal Drip, Hoarse Voice, Sore Throat, Wheezing, SOB, Chest Pain... Read more
Cough, Sinus pain, Rhinorrhea, Post Nasal Drip, Hoarse Voice, Sore Throat, Wheezing, SOB, Chest Pain, Sneezing, Fatigue, Myalgia, Nausea, Diarrhea, Chills.
50 2021-05-07 pain in extremity Fever (101 degrees) for about 12 hours Arm soreness for 2 days (with both 1st and 2nd shot)
50 2021-05-07 pain in extremity Fever (101.2) , chills, body aches, sore throat/achey ears, headache, nausea. I?ve had the sore ar... Read more
Fever (101.2) , chills, body aches, sore throat/achey ears, headache, nausea. I?ve had the sore arm since yesterday (no big deal re: that), but today I am too sick to function and can just lay here. Was told to expect some sickness after second shot but scared since first shot and how bad the second will be if it is worse than this.
50 2021-05-07 pain in extremity Extreme pain in arm and shoulder lingering 5 weeks after 2nd vaccine. Difficulty lifting arm overhe... Read more
Extreme pain in arm and shoulder lingering 5 weeks after 2nd vaccine. Difficulty lifting arm overhead or to remove shirt.
50 2021-05-08 feeling cold followed by very cold, and a headache. At night I started a lot of nasal fluid, accompanied by cough... Read more
followed by very cold, and a headache. At night I started a lot of nasal fluid, accompanied by coughing and intense body pain and fatigue. All day on Saturday. And today Sunday the 9th I continue with nasal fluid and headache. I am taking adviel every 6 hours to help with the headache and body pain and lots of fluids.
50 2021-05-08 numbness, tingling My vaccine(the first one) was mixed up with my husbands (below) so we don?t know which one I actuall... Read more
My vaccine(the first one) was mixed up with my husbands (below) so we don?t know which one I actually received and caused these reactions. My PCP said this can be affecting me neurologically hence the constant numbness,tingling,loss of feeling in leg and face.
50 2021-05-08 pain in extremity, tenderness My whole right upper chest is in pain since Saturday (Pfizer 1st vax right upper arm on Fri).., The ... Read more
My whole right upper chest is in pain since Saturday (Pfizer 1st vax right upper arm on Fri).., The pain started in my arm and moved to My upper chest... Now, Sunday, my whole right side chest hurts (outside muscles, not inside pain, i touch the muscles and it hurts to the touch),
50 2021-05-08 pain in extremity Headache, fatigue, aches, brain fog, sore arm 19 hours after shot Symptoms worsened over the day. D... Read more
Headache, fatigue, aches, brain fog, sore arm 19 hours after shot Symptoms worsened over the day. Developed dizziness, chills and low grade fever after 32 hours. Dizziness, headache and fatigue remained for at least 72 hours after shot. On day 6 (today) I noticed a hot area that was red but not raised, and itchy below the injection spot. I think it?s been there all along because I felt it several times, but never looked at it.
50 2021-05-08 pain in extremity 30 to 40 minutes after shot - neck pain, sharp pains through whole left side body, lower left back... Read more
30 to 40 minutes after shot - neck pain, sharp pains through whole left side body, lower left back pain with 2 mysterious bruises that came on lower left back not bumped evening of shot - whole left arm and hand ache and pain, hurt to move hand, body aches, ache at injection site 1st or 2nd evening after shot - left arm and hand didn't want to work or move smoothly "like dying battery" flickery or off on operation, but normal movement by morning by one week most symptoms gone -BUT- still ache left arm and hand and still ache left neck Today and yesterday sharp pain under left rib came back
50 2021-05-08 pain in extremity Slightly sore arm Tylenol 12hours
50 2021-05-09 weakness Woke up fine the next morning but then got two hives on my face, sneezing and iching. Body weakness... Read more
Woke up fine the next morning but then got two hives on my face, sneezing and iching. Body weakness later in the day. Thoughtout the next week experienced chills, up and down temp around 99.7 at the highest. Difficulty concentrating at 72 hours past vaccine. Periodic sore throat post 4 days of vaccine. Very concerned with getting the second dose.
50 2021-05-09 weakness Felt like arm is asleep, headache, chills, weakness, dizzy, nausea, vomiting, diarrhea and very tir... Read more
Felt like arm is asleep, headache, chills, weakness, dizzy, nausea, vomiting, diarrhea and very tired.
50 2021-05-09 migraine Patient received 2nd COVID vaccine 1 week ago and had a migraine since that day. Came to ER for eva... Read more
Patient received 2nd COVID vaccine 1 week ago and had a migraine since that day. Came to ER for evaluation.
50 2021-05-09 tingling, electric shock sensation Shocking/tingling sensation (felt like a electrocution) in private area - started moving up to stoma... Read more
Shocking/tingling sensation (felt like a electrocution) in private area - started moving up to stomach and then to foot, back, arm them to around whole body. Same day as the shocking sensation - felt pressure on elbow and knees. Diarrhea for duration of 3 days. Join paint knees. Lasted for the whole day - no longer occurring.
50 2021-05-10 inability to speak Foggy head, memory lapses, difficulty recalling words, inability to focus, difficulty in concentrati... Read more
Foggy head, memory lapses, difficulty recalling words, inability to focus, difficulty in concentrating, difficulty in remembering what I was doing, lightheaded, not thinking clearly (and causing small injuries as a result)
50 2021-05-10 weakness 24 hours after, felt very weak and dizzy and then did pass out for 45 seconds to one minute.
50 2021-05-10 feeling hot Fatigue, dehydration, pain at injection site and muscle pain for 7 days after injection. Feeling of... Read more
Fatigue, dehydration, pain at injection site and muscle pain for 7 days after injection. Feeling of heat during injection at in arm.
50 2021-05-10 numbness Within a minute of receiving shot I had numbness on the left side of my face near my cheek and mouth... Read more
Within a minute of receiving shot I had numbness on the left side of my face near my cheek and mouth. A short time laterÂ… less than 3 minutes I had difficulty swallowing. I also experienced a POUNDING heart. It felt as though it would pound out of my chest. It was VERY strong not like rapid but pounding so hard. The heart pounding and difficulty swallowing lasted less than 5 minutes. The facial numbness lasted a few hours.
50 2021-05-10 pain in extremity Later in day arm pain Next day fatigue, headache, dizziness, constipation, arm pain, fever, sore thr... Read more
Later in day arm pain Next day fatigue, headache, dizziness, constipation, arm pain, fever, sore throat It?s been 2 days and slightly better but still there. Couldn?t work for last two days.
50 2021-05-10 pain in extremity Pfizer BioNTech COVID-19 Vaccine EUA after the first dose, during the early morning hours (1 am) the... Read more
Pfizer BioNTech COVID-19 Vaccine EUA after the first dose, during the early morning hours (1 am) the next day I woke up and started to experience a number of symptoms. I experienced, a slight fever (98.?), all -over body muscle aches, chills, severe headache and neck ache. Also not long after having the shot in my left arm, probably an hour after the shot was administered my arm was really sore and I it was difficult lifting it or moving it until all the symptoms wore off the following day around 4 p.m.
50 2021-05-10 pain in extremity extremely tired; arm pain; This is a spontaneous report from a contactable consumer (patient). A 50-... Read more
extremely tired; arm pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EP7534, expiration date: 31Jul2021) via an unspecified route of administration at arm right on 20Mar2021 14:00 at age of 50-year-old at single dose for COVID-19 immunization. Medical history included ongoing blood pressure high from 2018, ongoing high cholesterol from 2018. Patient had no history of previous immunization with the Pfizer vaccine, no additional administered vaccines, no prior vaccinations within 4 weeks. Patient had no family medical history relevant to the events. Concomitant medications were not reported. It was reported that patient took high blood pressure and cholesterol medication. During the original call, patient's husband mentioned wife had the first shot and her arm was killing her, he thought the guy who gave it hit an artery or something. Caller handed the phone to his wife and she reported her symptoms of the Pfizer COVID vaccine. Patient stated she had arm pain on 20Mar2021 and felt extremely tired on 10Apr2021. It was explained she couldn't shake the tired feeling and it lasted for the week. She said she was still tired but not as tired as last week. Caller stated she has recovered with lasting effects. Patient did not treat her symptoms in any way. Patient received second vaccine in the right upper arm on 10Apr2021 14:00 (Lot number ER8734, Expiration date 31Jul2021). Outcome of arm pain was recovered on 22Mar2021, of extremely tired was recovered on 16Apr2021. Follow-up attempts are completed. No further information is expected.
50 2021-05-10 pain in extremity Extremely heavy menstrual period right after vaccine.; Fast heart rate; Warm body temperature; Nause... Read more
Extremely heavy menstrual period right after vaccine.; Fast heart rate; Warm body temperature; Nausea; Bloated; Left arm pain; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. The patient did not have COVID prior to vaccination. Concomitant medication(s) included ibuprofen taken for an unspecified indication, start and stop date were not reported; benzylpenicillin (PENICILLINE [BENZYLPENICILLIN]) taken for an unspecified indication, start and stop date were not reported. It was reported that patient experienced "extremely heavy menstrual period right after vaccine, same day of given shot, heavy clotting, non-stop bleeding for hours", fast heart rate, warm body temperature, nausea, bloated and left arm pain on 12Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature was warm and heart rate was fast on 12Apr2021. The patient was not tested for COVID post vaccination. Information on the lot/ batch number has been requested.
50 2021-05-10 tremor, weakness, seizure Shakes that feel like a seizure; Shakes that feel like a seizure; Choking; Side effects are minimal ... Read more
Shakes that feel like a seizure; Shakes that feel like a seizure; Choking; Side effects are minimal unless she got sun on her; sunlight made her sick; Nauseous; Light headed; Weak; Sweaty but chills; Sweaty but chills; Brain fog got really bad; This is a spontaneous report from a contactable consumer(patient). The 50-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 22Apr2021 16:00 (Lot Number: ER8736) as first dose, single for covid-19 immunization. Medical history included Polycystic ovarian syndrome(PCOS), Neuropathy, disabled, asthma, allergies, beat kidney cancer, autoimmune deficiency, anemic, gastric bypass. Concomitant medications included hydrocodone 10-325, escitalopram oxalate (LEXAPRO) 20mg, omeprazole 20mg. The patient had known allergies: tramadol, melamine, gabapentin. The patient stated sunlight made her sick. Side effects are minimal unless she got sun on her. Even through window. She got nauseous, shakes that feel like a seizure, light headed, weak, choking, sweaty but chills. Brain fog got really bad. She had brain fog from it but to the point she forgot she was headed to the bathroom after sunlight touched her. She had been able to handle indirect sunlight until today. Now she can't have any sunlight touch her without a reaction. Direct or Indirect. Nothing helped. Just sundown. Once the sun went down, the side effects calmed down. Events occurred on 26Apr2021 14:30 with outcome of recovering. There was no treatment received. Since the vaccination, the patient had not been tested for COVID-19.Case was assessed as non-serious by reporter.
50 2021-05-11 flushing, tingling I walked over to another chair & sat down to be monitored for 15 minutes after injection. Within a m... Read more
I walked over to another chair & sat down to be monitored for 15 minutes after injection. Within a minute a tasted a metallic taste & felt tingly in my chest i ignored for like another minute then i felt my heart pounding i notified staff. My blood pressure was checked 180/108 heart rate 103(average bp 110/70 hr 68). i was given benadryl 50 mg by mouth. I was confused as why i would taste medicine injection given properly shouldnt have entered my bloodstream so quickly. I was monitored for an additional 15 minutes w repeated bp/hr checks at 30 minutes bp still elevated at 160/90 hr 78 i didnt have tingling in chest didnt have pounding in chest bp still elevated but had lowered some.my husband present firefighter/ emt.i had reaction to 5fu chemo med and had same with elevated hr & bp but worse had to receive iv steroids& this was after 3 months of chemo. My bp & hr also ekevate if i eat gluten. I am aware being an RN and having had previos reactions that the second shot msy cause a more ssvere reaction.i will not be taking any further covid vaccine until i know what caused this reaction. My son took his vaccine at same location without incident that day he has no allergies. I only felt heache & slight nausea feeling flush approximately 2 hours after i left place of vaccination.no other problems since.
50 2021-05-11 muscle spasms Muscle spasms, TIGHT muscles, esp neck and head. Headache.
50 2021-05-11 unresponsive to stimuli Was notified by observer that patient was non-responsive and that it appeared that patient may fall.... Read more
Was notified by observer that patient was non-responsive and that it appeared that patient may fall. Approached patient, she was indeed not verbally responsive or able to follow verbal commands. Patient repeatedly opening and closing eyes and appearing diaphoretic, unable to hold self up in chair. Transferred patient to wheelchair and moved to triage area, patient remains unable to follow commands or hold self up in wheelchair. Called emergency line and notified them of incident and also let on call doctor know who agreed to calling 911. Patient transferred to other facility.
50 2021-05-12 weakness The morning of May 6 started chills, aches , nausea, fever, continued into next day. Fever & Nausea... Read more
The morning of May 6 started chills, aches , nausea, fever, continued into next day. Fever & Nausea continue day 2 No appetite. Day 3 was able to get out of bed No appetite Nausea and feverish. Day 4 lack of energy no appetite diarrhea. Day5 still no appetite stomach aches muscle aches fatigue little appetite. Day6 still little appetite fatigue stomach aches Day 7 fatigue little appetite diarrhea Day 8 same
50 2021-05-12 pain in extremity, muscle twitching twitches in her legs and then pain after; Face periodically twitches; eye twitches periodically espe... Read more
twitches in her legs and then pain after; Face periodically twitches; eye twitches periodically especially after sneezing or coughing; twitches in her legs and then pain after; Face periodically twitches; eye twitches periodically especially after sneezing or coughing; Face periodically twitches; eye twitches periodically especially after sneezing or coughing; stinging in her legs and it went up to her waist and felt like a band around her waist; stinging in her legs and it went up to her waist and felt like a band around her waist; Unexpected weight loss; no appetite; Unexpected weight loss; no appetite; This is a spontaneous report received a contactable nurse, the patient. A 50-year-old adult female received the first dose of BNT162b2 (solution for injection; Lot EW0158 and expiry information not provided) as a single dose via unspecified route in the right arm on 08Apr2021 at 19:30 (at 50-years-old) for COVID-19 immunisation. Relevant medical history included COVID with insomnia (Nov2020). There were no concomitant medications or past drug history reported. The patient reported as soon as she got the shot, she did not feel sick or nauseated, maybe she had no appetite, but she has lost ten pounds three weeks. States before the vaccine she was 138 pounds. The patient reported that on 18Apr2021, reported as eight to ten days later she developed stinging in her legs and it went up to her waist and felt like a band around her waist. The patient reported that on 20Apr2021 she experienced twitches in her legs and then pain after, her face periodically twitches; eye twitches periodically especially after sneezing or coughing. The patient reported that she had COVID back in Nov2020 and she had some problems after and then recovered. States she just got the Pfizer COVID vaccine three weeks ago and she did really well with the first one; however eight to ten days later, she noticed stinging in her legs and it went up to her waist and felt like a band around her waist. Then she started having twitches in her legs, and then pain, states the twitches have remained, she cannot see them, but she can feel them. Caller states her face periodically twitches as well. Her eye will twitch periodically when she sneezes or coughs. The patient, a retired nurse, assessed the events as medically significant, because she needs to know if it is something more serious. The patient denied any visits to the emergency room or to any doctor's office for the events reported. The patient reported that she called a few neurologists to see if she could have gotten in but they are so booked up that she could not get an appointment until August. The patient stated that the neurology place said they are seeing some very strange things, so the patient believes she is not the only one. The reporter stated that maybe because she had COVID, she does not know if it is because of that, but maybe the first one acting is acting like the second dose for her. The patient inquired if it was okay to get the second dose. The outcome of the event stinging in her legs and it went up to her waist and felt like a band around her waist was recovered on 20Apr2021. The outcome of the event weight loss; no appetite, twitches in her legs and then pain after, and Face periodically twitches; eye twitches periodically especially after sneezing or coughing was not recovered.; Sender's Comments: Based on a compatible temporal association a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-05-12 pain in extremity Fever Chills and Sore Arm. Does not want revaccinate at this time
50 2021-05-13 inability to speak, pain in extremity, tingling, weakness Pain in the left arm, tingling down to fingers and up to the neck into the head. The patient develop... Read more
Pain in the left arm, tingling down to fingers and up to the neck into the head. The patient developed expressive aphasia, extreme fatigue, weakness and stupor Pulse: 76 Resp. 16 SPO2 99 BP 130/88 Discharge to emergency room/ department or urgent care
50 2021-05-13 weakness, night sweats I am the daughter of a late medical researcher Dr. so please listen to what I am saying - severe diz... Read more
I am the daughter of a late medical researcher Dr. so please listen to what I am saying - severe dizziness, nauseous, weakness, fatigue fever, chills, aches, bad taste, and very in mouth, and incredibly emotionally terrifying- those have subsided except at 7 weeks tomorrow - still dizzy, night sweats, over all weakness, and am scared. Am presently debilitated by this. Blood test came back with a higher ANA. Saw a rheumatologist and will follow up this Tuesday. Periods have been thrown off as well. Got it two weeks ago and then again today. The worst is the dizziness and weakness. There must be more to treat people who are suffering like me.
50 2021-05-13 numbness Received 2nd dose of Pfeizer covid 19 vaccine on 4/24/2021. 4 days after, she experienced a numn... Read more
Received 2nd dose of Pfeizer covid 19 vaccine on 4/24/2021. 4 days after, she experienced a numnbess of L side of stomach, to L side of back. Near her shoulder blade. Felt like novacaine. The sx was steady for 2.5 weeks, then it improved rapidly over the past 2-3 days, and now It has resolved almost 100% Got both shots L arm. No ha/ no t dizzy, no sob, no cp, no abdo pain, no n/v/d, No swelling, no rash.
50 2021-05-14 bell's palsy Bell's palsy; metallic, numb sensation on end of tongue; metallic, numb sensation on end of tongue; ... Read more
Bell's palsy; metallic, numb sensation on end of tongue; metallic, numb sensation on end of tongue; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08Apr2021 at 09:45 AM (at the age of 50 years old) (Lot Number: ew0162, unknown expiration) as 1st dose, single for COVID-19 immunization. Medical history included chronic atopic dermatitis, mild asthma, sulfa allergies, latex allergies, allergies of peanuts and almond, banana peel allergies, allergy to tomatoes, sesame allergy, and shrimp allergy. Concomitant medications included dupilumab (DUPIXENT); hydroxyzine hcl; and ibuprofen. The patient experienced metallic, numb sensation on end of tongue and Bell's palsy on 23Apr2021. The events resulted in emergency room/department or urgent care visit. The patient received prednisone and valacyclovir as treatment for the events. No other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not yet recovered from the events. No follow-up attempts are possible. No further information is expected.
50 2021-05-14 discomfort, muscle spasms Approximately 36 to 48 hours post injection, menstruation started although it was not on schedule (I... Read more
Approximately 36 to 48 hours post injection, menstruation started although it was not on schedule (I just had one only 2 weeks ago). The bleeding became excessive over the hours, to the amount I have never experienced in my entire life. It also accompanied discomfort such as pain and crumps, which I also have never experienced during regular period. As of today (3 days later), bleeding still remains heavy.
50 2021-05-14 tenderness Tenderness on left collarbone and tenderness under left arm pit; This is a spontaneous report from a... Read more
Tenderness on left collarbone and tenderness under left arm pit; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 05Feb2021 15:00 (at the age of 50-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included type 2 diabetes, allergy to penicillin, COVID and allergy. Concomitant medication included cetirizine hydrochloride taken for allergy, start and stop date were not reported. The patient experienced tenderness on left collarbone and tenderness under left arm pit on 06Feb2021 13:00. Tenderness was treated with topical steroids then oral steroids and it was resolved on an unspecified date in Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained
50 2021-05-16 weakness 1. One week after the 1st shot, skin rash on the back of my neck. Lasted about a couple of weeks. 2... Read more
1. One week after the 1st shot, skin rash on the back of my neck. Lasted about a couple of weeks. 2. On the same day of the 2nd shot, more than 30 tiny subcutaneous bleeding points on my left eye lid. Recovered the next morning. 3. Two days after the 2nd shot, monthly period came, 6 days earlier than it should be, with interval from the last month of 22 days (usual interval of 28 days). And it took about 2 weeks to almost finish (last month it was 5 days to finish). 4. Generally feel tired and weaker ever after the 2nd shot. Not recovered as of today.
50 2021-05-16 breast pain Under arm left arm and left breast are in excrutiating pain.
50 2021-05-16 numbness Immediately after inject of the first Pfizer vaccine, she could taste the vaccine in her mouth. The... Read more
Immediately after inject of the first Pfizer vaccine, she could taste the vaccine in her mouth. Then developed her mouth started "watering profusely". She had to swallow constantly. Then swallowing became difficult, she had chest tightness, and numbness in hands/arms. S he was moved to the rescue area with "fire rescue". Her BP 160/105. EMS arrived, transfer recommended. You consulted with your daughter who is a nurse, and opted to return home. She was at the fairgrounds for 2 house. She did not receive medications. Was provided crackers and water. After arriving home, her initial symptoms resolved, but she felt nauseated and "terrible". Over the next 3 days she had swollen lymph nodes on the side of the injection and felt "like she had been hit by a truck". After 3 days, those symptoms resolved and she felt well.
50 2021-05-16 migraine I started bleeding even though I was not due for my period for another 3 weeks. I also had a massive... Read more
I started bleeding even though I was not due for my period for another 3 weeks. I also had a massive migraine headache 24 hours later and have had a headache ever day since. I never get headaches and my periods are typically very short and light .
50 2021-05-16 tingling, numbness Numbness and tingling sensation on the left hand. Hard to extend the pinky finger on the left hand,... Read more
Numbness and tingling sensation on the left hand. Hard to extend the pinky finger on the left hand, feels like a nerve is pinched.
50 2021-05-16 cold extremities Severe chills, cold extremities, body aches, muscle aches, stomach pain, low appetite, diarrhea, sev... Read more
Severe chills, cold extremities, body aches, muscle aches, stomach pain, low appetite, diarrhea, severe headache (third day after shot)
50 2021-05-16 tremor, feeling cold (DOB 06/10/1970) received the first dose of Pfizer with lot number EP7534 exp 03/20/2021 at 1530. At... Read more
(DOB 06/10/1970) received the first dose of Pfizer with lot number EP7534 exp 03/20/2021 at 1530. At 1538 client walked to EMT station with her husband notifying EMT staff that client felt lightheaded and was moved to zero-gravity chair for closer monitoring. Client disclosed at 15:42 that she has been fasting since last night in anticipation for her colonoscopy the following day. Medical history was reviewed: heart problems, thyroid issues, cancer, and immunocompromised (Hashimoto). RN visually noted patient started having physical tremors, apple juice and water were offered to client by staff. No signs of respiratory compromise or itching/hives were noted. Vital signs at 1545: BP of 150/100, pulse of 76bpm, and 14 respirations per minute. Client reported feeling anxious and visibly wearing clothes with extremities exposed, RN staff discussed with husband getting jacket for client. Husband refused at this time, not wanting to leave as was actively providing emotional support to client. 1550 vital signs: BP of 140/90, pulse of 70bpm, and 14 irregular respirations per minute. Client refused oral nutrition interventions at this time in anticipation of colonoscopy. 1557 vital signs: BP of 140/90, pulse of 80bpm, and 16 respirations per minute. Patient accepted apple juice at this time. RN discussed with client if felt chilly, client stated just couldn't stop shaking, husband agreed to retrieve a jacket from the car. RN engaged with patient to provide distraction discussing what client had done prior in the day. Client remained alert and oriented x3 noting the gardening client had done prior to arriving for vaccination. 1606 vitals: BP of 150/100 and at this time client was offered EMS. Client agreed to having EMS called, EMS call was placed at 1606. 1610 EMS arrived with two paramedics and 1 EMT, client was moved into side hall for privacy and EMS assumed care of client. 1620 client left site to board the ambulance with her husband to take more tests on heart at a higher level of care, symptoms were not completely resolved. Client remained alert and oriented x3 on exit of site.
50 2021-05-17 numbness 5 weeks after second Pfizer shot I began experiencing un-explained dizziness and bilateral arm numbn... Read more
5 weeks after second Pfizer shot I began experiencing un-explained dizziness and bilateral arm numbness. It has lasted more than 2 weeks now.
50 2021-05-17 migraine Chronic pain and fatigue since 2nd shot, joint pain in feet and hands, migraines, hair falling out.... Read more
Chronic pain and fatigue since 2nd shot, joint pain in feet and hands, migraines, hair falling out. I have been on steroids for 2 months with little relief. I am a healthcare worker and have had to significantly cut back on my hours because I am physically unable to work long hours. I was completely fine before the vaccine with no pain or problems and working long 24 hour shifts.
50 2021-05-17 muscle spasms, numbness, tingling postmenopausal bleeding, muscle spasms of the left forehead, tingling/numbness of right hand at prio... Read more
postmenopausal bleeding, muscle spasms of the left forehead, tingling/numbness of right hand at prior viral rash
50 2021-05-17 pain in extremity, nerve pain Patient states she had nerve pain in elbow and wrist of left arm after the first COVID vaccine which... Read more
Patient states she had nerve pain in elbow and wrist of left arm after the first COVID vaccine which subsided a little, but never completely left. She did not disclose this at the time of the second shot on her VAR. Patient now states that she has excruciating pain ( nerve pain ) in the arm which the injection was given. She states that is started in her wrist and elbow again, but now it is in her shoulder and neck as well. The pain after her second shot started on Saturday evening and has continued to today.
50 2021-05-17 pain in extremity, sciatica diagnosed with Sciatica; intense pain in her buttocks; Pain in Hip; Pain in leg; Unable to sit; Unab... Read more
diagnosed with Sciatica; intense pain in her buttocks; Pain in Hip; Pain in leg; Unable to sit; Unable to sleep; unable to sit, sleep and therefore work; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 28Mar2021 (Lot Number: ER8732) as single dose for covid-19 immunisation. Medical history included high blood pressure, known allerges:-illins and some other medications. Concomitant medications included prednisone taken for an unspecified indication, start and stop date were not reported and high blood pressure medication. The patient previously received first dose of bnt162b2 on 07Mar2021 (Batch/lot number - EN6199) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Clinical course reported as: On 30Mar2021 (about 36 hours after injection, reported as 30Mar2021 07:00) patient woke up with intense pain in her buttocks, hip and leg. It was the worst pain ever, even lasting now but easing up finally. 2 weeks later she was diagnosed with Sciatica. She never had Sciatica before nor did she had symptoms that resemble Sciatica before. She was unable to sit, sleep and therefore work. The pain was the worst she ever experienced. Fast forward to now and she was finding out that she was not the only one that all of a sudden has Sciatica issues after the vaccine. She thought it was related. She was struggling but doing much better compared with the 1st 3 weeks. She 1st thought it couldn't be related but she had 2 other friends who all of a sudden have similar symptoms to her after getting the vaccine. So that was why she was reporting this. Treatment received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
50 2021-05-17 pain in extremity Shortly after the first shot, I had severe pain in my LEFT arm (opposite arm of shot), in the same v... Read more
Shortly after the first shot, I had severe pain in my LEFT arm (opposite arm of shot), in the same vacinity the shot was given. It was a constant stabbing/throbbing pain that lasted a few days. Then on 5/15 a month later, (LEFT arm, opposite arm of shot, same vacinity as the shot), I had the same stabbing/throbbing, constant pain start and last for at least 24 hours only this time the pain was significantly worse and even difficult to do things like open a jar, etc. I took Tylenol as I am not supposed to take other pain medicine and it did not help. I iced it but that didn't help either.
50 2021-05-17 pain in extremity injection site pain; left arm began to become sore; This is a spontaneous report from a contactable ... Read more
injection site pain; left arm began to become sore; This is a spontaneous report from a contactable other hcp. A 50-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 intramuscular, administered in Arm Left on 06Jan2021 12:00 as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, type 2 diabetes mellitus, hypersensitivity, food, or other products:Yes, illness from Nov2020 to an unknown date I was sick with covid-19 in November, covid-19 from Nov2020 to an unknown date I was sick with covid-19 in November, the stiff neck was one of the first symptoms I noticed, musculoskeletal stiffness from Nov2020 to an unknown date I was sick with covid-19 in November, the stiff neck was one of the first symptoms I noticed. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced injection site pain and left arm began to become sore. I received my 1 st vaccine in my left arm and my second in my right arm. About 10 minutes or so after receiving the second vaccine, my left arm began to become sore as if it had been injected into the left arm again. That went away later that night. I started to injection site pain the next day which lasted only a few hours, while with the 1st injection it lasted 3 or 4 days. This afternoon I noted that my neck was stiff 2 days after receiving my second dose. The only reason I mention that was when I was sick with covid-19 in November, the stiff neck was one of the first symptoms I noticed. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was recovered and left arm began to become sore with outcome unknown. Follow-up attempts have been completed and no further information is expected.
50 2021-05-17 seizure like phenomena swollen tongue, felt like she was going to have seizure, 105 fever for 5 days, coughing, sneezing, h... Read more
swollen tongue, felt like she was going to have seizure, 105 fever for 5 days, coughing, sneezing, headache, couldn't move arm, felt fluish,
50 2021-05-18 feeling hot, pain in extremity Blood stain in her right eye; Felt her right eye was pounding a little; Her arm was hurting a little... Read more
Blood stain in her right eye; Felt her right eye was pounding a little; Her arm was hurting a little bit; Her arm was very hot, extremely hot; Headache; A lot of pressure to her head; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 01May2021 16:10 as 1st dose, single for COVID -19 immunization. Medical history and concomitant medications were not reported. The patient reported she had her COVID vaccine on 01May2021 at 16:10 in the afternoon and about an hour later the headache started. In some occasions it felt like a lot of pressure to her head. On 03May2021, she felt her right eye was pounding a little and then when she woke up in the morning of 04May2021, she saw the blood stain in her right eye. The pounding in her eye was not pounding as much in the afternoon for quite a while but then it stopped that same day on 03May2021. On 01May2021, it was also reported that her arm was hurting a little bit and it stopped on 03May2021; and on 01May2021, her arm was very hot, extremely hot. No events required a visit to emergency room or physician office. The outcome of the events headache, "blood stain in her eye", and "a lot of pressure to her head" was not recovered, "felt her right eye was pounding a little " and "her arm was hurting a little bit" recovered on 03May2021, and "her arm was very hot, extremely hot" recovered on 01May2021. Information on the batch/lot number has been requested.
50 2021-05-18 feeling hot Patient felt hot and was sweaty right after vaccination. She felt like she wanted to lay down. When ... Read more
Patient felt hot and was sweaty right after vaccination. She felt like she wanted to lay down. When the nurse was trying to bring patient to the cot the patient fainted before reaching the cot. A clerk called 911. The nurse administered 1 dose of epipen at 11:35 am. Patient regained consciousness. She was able to converse with the nurse and was able to drink some water. Her vital signs at 11:39 AM were oxygen saturation of 99 %, heart rate of 42, and blood pressure of 87/60. Patient was brought to the cot to lay down and wait for EMS. EMS arrived blood pressure had increased to 104/68 and heart rate to 50 and patient had some returning of skin color wasn't as pale. Patient did mention she thinks she may have been dehydrated. She was then brought to the ED for further evaluation.
50 2021-05-18 muscle spasms I got my period today; moderate to severe PMS symptoms; cramps; back pain; breast tenderness; This i... Read more
I got my period today; moderate to severe PMS symptoms; cramps; back pain; breast tenderness; This is a spontaneous report from a contactable consumer(herself). A 50-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ew0162, Expiry date not reported), dose 2 via unspecified route of administration in left arm on 13Apr2021 09:15 (at age of 50-year) as single dose for COVID-19 immunization. Patient medical history was not reported. Patient concomitant medication included bupropion hydrochloride (welbutrin) for unspecified indication from unknown date. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER2613, Expiry date not reported) via unspecified route of administration in left arm on 20Feb2021 13:15 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On 30Apr2021, she got her period today, (after 31days of second shot). Patient stated that I am 51years old and I have an IUD. I had a period in over 2 years. I had moderate to severe PMS symptoms for the last 7 days including cramps, back pain & breast tenderness. Not an alarming side effect, just weird. The events assessed as non-serious. No treatment was received by patient. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
50 2021-05-18 pain in extremity Sore arm even after 6 weeks on left side. Used a cold pack and ibuprofen for pain.
50 2021-05-18 tingling, muscle spasms, numbness Muscle spasm in neck,; Numbness and tingling at the left side of the face; Numbness and tingling at ... Read more
Muscle spasm in neck,; Numbness and tingling at the left side of the face; Numbness and tingling at the left side of the face; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 50-years-old non pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via, administered in Arm Left on 12Mar2021 (at the age of 50-years-old) (Batch/Lot Number: EL 9266) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included asthma, ulcerative colitis, rheumatoid arthritis, diabetes, hypertension, apnea, and allergy to sulfa. drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid 19 and has not been tested for COVID-19 Since the vaccination. Patient reported that she has allergies to medications, food, or other products: Sulfa. Concomitant medication(s) included prednisone, insulin lispro (HUMALOG), losartan potassium (COZAAR) montelukast sodium (SINGULAIR) and vedolizumab (ENTYVIO) taken for an unspecified indication, start and stop date were not reported. On 12Mar2021 08:15 the patient experienced muscle spasm in neck, numbness and tingling at the left side of the face. Therapeutic measures were taken as a result of muscle spasm in neck, numbness and tingling at the left side of the face and treatment included BENADRYL and DECADRON. The events were resulted in emergency room visit. The outcome of events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
50 2021-05-18 tingling Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, to... Read more
Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; Tingling & Swelling of lower face, lips, tongue, throat; This is a spontaneous report received from a contactable female consumer (patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6207, Expiration date was not reported), via an unspecified route of administration on 27Mar2021 09:00 first dose single for covid-19 immunisation. Medical history included fatty liver, diverticulitis, migraine and cigarette smoke. The patient concomitant medications were not reported. The patient previously took sulfonamide (Sulfa / FQ drugs) allergy to sulphonaminde and histamine allergy to histamine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination of antioxidant Green Tea and Liver Cleanse Tea and Vitamin C. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient experienced Tingling and Swelling of lower face, lips, tongue, throat on 28Mar2021 02:30 AM. Patient visited the emergency room. As per the reporter seriousness criteria for the events swelling of lower face, lips, tongue, throat was medically significant. Patient received treatment of Benadryl-self-administered prior to ER. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021430745 similar report from same reporter
50 2021-05-19 numbness After first vaccine, I went to ER on April 18th with difficulty breathing. Right leg felt a little n... Read more
After first vaccine, I went to ER on April 18th with difficulty breathing. Right leg felt a little numb. EKG normal. After second vaccine on April 29th 2021, I had new symptoms for the first time. On May 8th my heartbeat became very high for no reason. Called doctor and went three times to various appointments. Took ECG again. Since heart beats were very high even with light movements, I am wearing a heart monitor for two weeks. I have no pre-existing conditions. All blood work normal.
50 2021-05-20 bell's palsy Bells palsy
50 2021-05-20 feeling hot, discomfort Started with warm feeling moving up arm to neck, head and face on left side. Heart rate went from 68... Read more
Started with warm feeling moving up arm to neck, head and face on left side. Heart rate went from 68 to 95, with tight feeling in chest and throat. Stayed at clinic for over an hour. Took Tylenol and Benadryl that night and the next day. Feeling in shoulder, neck and face continued to feel like the site of the injection ( felt aching and numb, but not to the touch). Today I am feeling better with slight discomfort in arm and neck.
50 2021-05-20 migraine, feeling cold Injection site pain started approx 4.5hrs after shot (administered at 1:30pm on Tues.)Cold to the bo... Read more
Injection site pain started approx 4.5hrs after shot (administered at 1:30pm on Tues.)Cold to the bone chills approx 3am Wends. Woke up fatigued, slightly nauseous, no appetite, light sensitive migraine, pain in all joints, muscle pain (8am Weds.). All above side effects continued to worsen through the morning. At 11:45am I got into bed and aside from getting more water to drink and bathroom breaks, I stayed there until Thurs. morning 8am. Thurs. chills were gone. Migraine, joint and muscle pain subsided, but still had a slight headache. Nausea decreased enough to bring back appetite. Headache gone approx 11am. Fatigued continued until approx 5pm Thurs.
50 2021-05-21 numbness, tingling Pt was given 1st dose of pfizer vaccine on 5/14. She reported a history of allergic reactions and ha... Read more
Pt was given 1st dose of pfizer vaccine on 5/14. She reported a history of allergic reactions and has the epi pen at home. Pt was asked to wait by pharmacy for at least 30 min due to hx. Pt reported feeling a little weird and tingly after the shot and benadryl was offered and accepted by the pt. I requested she stay for observation and she recovered and felt well within another 30 minutes. I requested the patient call to check in on 5/15 and go to er or urgent care if experiencing signs of an allergic reaction. Pt called to check in and was feeling some tingling and numbness on the left side of her bottom lip. I advised that she go to get evaluated for potential allergic reaction and follow up with us once she has. She agreed to seek treatment. She did not feel the need for emergency services to be called. Pt called back to report visit to ER on 5/15 and they suspect a reaction from the shot. The patient is still experiencing some numbness in her face and arm. Pt was evaluated at the er and reports only receiving some pain medicine prior to discharge.
50 2021-05-22 night sweats Chills, night sweats, no fever, dry cough, lost of smell and taste. Tested positive for COVID-19 on ... Read more
Chills, night sweats, no fever, dry cough, lost of smell and taste. Tested positive for COVID-19 on May 20th.
50 2021-05-23 migraine Headache started seven days after vaccine. started with an ocular migraine and then changed to a hea... Read more
Headache started seven days after vaccine. started with an ocular migraine and then changed to a headache centered on right temple. radiated to scalp and neck unless i took both advil and ibuprofen. Headache lasted ten days and then stopped.
50 2021-05-24 feeling hot, weakness, flushing That first few minutes after nausea and headache. Got home and I started having warm, flushing feeli... Read more
That first few minutes after nausea and headache. Got home and I started having warm, flushing feeling. Like you feel hot inside. I took my temperature. It was 99 and then 100. I started feeling like somebody beat me up. My body was over fatigued and feeling weak - sore everywhere. I went to bed as I was dizzy, too. I didn't want to eat anyways because I was nauseated. It was up to 102. I had fever, nausea, and that night my temperature was even higher and I couldn't get out of bed. I had headaches. I took 2 500 mg (1000 mg) of Tylenol. I took Pepcid. I tried to eat something. That headache was so severe and I took Benadryl. That continued on for the next week. I didn't want to keep taking Tylenol all the time. I took 1000 mg and then maybe Ibuprofen or 500 mg of Tylenol later that day and Benadryl that night. Going to the next week, I still had fever, headache, I had gurgling stomach. It felt like someone was working on something inside of my tummy. It wasn't gas. It felt like someone was touching different organs and it was making feel nauseated. I had dizziness if I didn't take Benadryl. Once I woke up, I'd have the headache, dizziness would be better and I'd try to eat but the nausea would still be there - I vomited once or two times. Body sore, really really tired. Chills lasted for more than a week - especially at night. Face was flushed from the first day of injection and it was flushed for about a week because I had a fever. I was so weak - couldn't do anything - like I had the flu but more severe symptoms. Would walk down our stairs and I would already be exhausted. Severe for first two weeks and then the nausea symptoms lessened but it's still on and off when I went back to work. The headache was just there and not going away - my head feels so heavy. Like something is puncturing me - sharp pain. I do have a very high tolerance of pain and so if I say it's hurting, it's really bad. I can tolerate more than other people. Severity of headache has been better since end of April - I was working and it was so hard. I'm a nurse and that's why I can't take off that long from work. The moment I didn't have the fever anymore, I went back to work even though I was suffering from the other symptoms still. . I missed two weeks of work. Because I'm part-time, it wasn't covered to have the time off. The Tylenol or alternating with Motrin would help lessen the pain a little but it was not getting rid of the pain so I just stopped taking it because I didn't want to damage my Kidneys. Headache, nausea and dizziness is at this time is about 80% gone. It's not as severe as those first month now by the first week of May.
50 2021-05-25 weakness, tremor It seems that soon after vaccine my daughter who has Dementia got very weak. Legs and arms shaky. I ... Read more
It seems that soon after vaccine my daughter who has Dementia got very weak. Legs and arms shaky. I am personally doing exercises with her to try to help with weakness. and build strength
50 2021-05-25 flushing Approximately 15 minutes after vaccination, pt began to feel flushed, tachycardic, and mildly dizzy.... Read more
Approximately 15 minutes after vaccination, pt began to feel flushed, tachycardic, and mildly dizzy. BP and HR were elevated at 148/70 and 102 respectively. 5 minutes later her symptoms began to resolve, BP 138/82 and HR 85. After another 5 minutes, pt reported symptoms were fully resolved and monitoring was discontinued.
50 2021-05-25 pain in extremity Minor allergic reaction; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb t... Read more
Minor allergic reaction; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; sore arm; This is a spontaneous report from a contactable consumer (the patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0151), dose 1, single dose via an unspecified route of administration, administered in arm left on 14Apr2021 for covid-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Past drug event included allergy to ampicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced minor allergic reaction, swollen, tingling, and numb tougue and lips and sore arm on 14Apr2021. Therapeutic measures taken as a result of minor allergic reaction, swollen, tingling, and numb tougue and lips. and sore arm included diphenhydramine (BENADRYL). The outcome of minor allergic reaction, swollen, tingling, and numb tongue and lips, sore arm was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of minor allergic reaction cannot be excluded.
50 2021-05-26 numbness 4 days after 2nd injection I experienced sudden sharp pain in left heel when knee is straight and to... Read more
4 days after 2nd injection I experienced sudden sharp pain in left heel when knee is straight and toes flex up. I experience this pain each time I make this motion. About a week later I noticed persistent numbness in the same area, left heel around outside and back of heel. After a week I called my PA for appointment and on May 25 I saw her and got a full blood panel and an xray. She referred me to a podiatrist but also mentioned it might be connected to the vaccine, as other cases of neuralgia have been noted.
50 2021-05-26 pain in extremity pain in her arm in the muscle where the needle was placed; pain in her arm in the muscle where the n... Read more
pain in her arm in the muscle where the needle was placed; pain in her arm in the muscle where the needle was placed; she almost fainted; had so much tightness in her throat; couldn't swallow; the other arm pain; 8-10 days late for her period; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8731 and expiration date not provided), via an unspecified route of administration, in arm left, on 18Apr2021 09:30 (at the age of 50-year-old), at single dose, for COVID-19 immunization. Medical history reported as no. Concomitant medications were not reported. No prior vaccinations within 4 weeks. Patient was scheduled for the second dose on 09May2021 but she had doubts because of her reaction to the first dose. The patient experienced 8-10 days late for her period in Apr2021; pain in her arm in the muscle where the needle was placed on 18Apr2021; almost fainted on 18Apr2021; had so much tightness in her throat on 18Apr2021;couldn't swallow on 18Apr2021; and the other arm pain on 18Apr2021. Patient stated this was not an allergic reaction and the vaccination provider was about to administer the epi-pen but then she did not. Patient would like to know if her side effects are normal and if she should receive the second dose. Patient got the first shot on 18Apr2021 and she was scared of needles so she just didn't look at them but this one... Patient stated as soon as she got the shot, she had pain in her arm in the muscle where the needle was placed. Patient stated it's not a big deal. Patient stated the pharmacy said it's ok to feel pain and told caller to go sit down and they would be with her in half an hour or so. Patient stated she didn't even make it through the door, she almost fainted and could not hear what she was saying, she had so much tightness in her throat and she couldn't swallow. Patient stated it lasted about 2 to 3 minutes (also reported "lasted for 3-4 minutes"). Patient stated they called an ambulance but it took them 15 minutes to get there and she felt better by then. Patient stated because they told her to wait and she couldn't even get through the door so she just laid on the floor and her throat got so tight, she was frightened. Patient stated it lasted about 5 minutes, actually. Patient confirmed her symptoms began and ended on 18Apr2021. As for "hurting in her muscle; arm pain", patient stated she had the arm pain for two days but then her whole arm started hurting in that arm, but that was a different pain. Patient stated she got the shot at 09:30 in the morning and by 16:00 afternoon she started feeling the pain. Patient stated the pain from the needle when she got the shot, that pain lasted 5 to 6 hours or maybe she would say less. Patient stated after 16:00, then the other arm pain started. Patient stated she was putting ice on and off it for arm soreness overnight and into the next day. Patient confirmed her arm pain ended 19Apr2021. Patient confirmed she had recovered completely from all symptoms. Patient stated she didn't have any pains or anything so she would think she has recovered. Patient stated she went to her physician and the doctor suggested that she should take the second shot. Patient stated she also was 8-10 days late for her period. Patient stated something happened and she said she couldn't do it because she was going to get her period and then it didn't come and days passed by. Patient stated she was supposed to get it 21Apr2021 or 22Apr2021, supposed to get it between 21Apr2021 and 25Apr2021 and she got it yesterday, 04May2021. Patient stated as soon as it passed 26Apr2021, but she was also 51 and menopausal so it might be that, but she doubts it. No emergency room or physician office require for events. Treatment received for event "the other arm pain" included putting ice on and off. The outcome of the event "8-10 days late for her period" was recovered on 04May2021; of "pain in her arm in the muscle where the needle was placed/ almost fainted/ had so much tightness in her throat/ couldn't swallow" was recovered on 18Apr2021, of "arm pain" was recovered on 19Apr2021. No follow-up attempts are possible. No further information is expected.
50 2021-05-26 tingling, tremor, flushing, numbness Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Me... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium
50 2021-05-27 weakness "Pfizer-BioNTech Covid 19 vaccine EUA": About 24 hours after my second shot, I felt strong nausea, l... Read more
"Pfizer-BioNTech Covid 19 vaccine EUA": About 24 hours after my second shot, I felt strong nausea, losing control of the environment, feeling very unwell, weak, blood pressure must have dropped, my vision had darkened, I was about to collapse on the floor had I not reached my bed quickly. Couple of minutes later I had the urge to vomit but nothing came out, and then I had a normal bowl movement. After all that, I felt like the pressure had been released, took 1 tylenol, and went back to bed to rest. It's been 4 days now since the fainting symptoms, and I've been fine so far. The scary part was really the fainting symptoms, I wasn't expecting that.
50 2021-05-27 pain in extremity Severe Calf pain in left leg after 1st shot (week after) and now 2nd shot (week and a half after). ... Read more
Severe Calf pain in left leg after 1st shot (week after) and now 2nd shot (week and a half after). Feels like someone is tasering my leg.
50 2021-05-28 weakness Experienced loss of appetite/ lost appetite; Getting depressed, it isn't right in head/ feeling depr... Read more
Experienced loss of appetite/ lost appetite; Getting depressed, it isn't right in head/ feeling depressed; Something isn't right mentally/ couldn't connect the thought to switch the action/ delayed response to do the actual action; When getting ready to make any type of motion or walk, equilibrium is off; Pressure in the back of head; Weakness/ weak; Fatigue; This is a spontaneous report from a contactable consumer. A 50-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, distribution number and expiry date was not reported) via an unspecified route of administration on 21Jan2021 (at the age of 50-year-old) in left arm as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not received any other product and investigation assessment was not reported. As per the description, the caller stated, she received the first dose of the Pfizer covid vaccine last Thursday i.e. on 21Jan2021. Since she got the covid vaccine she experienced fatigue, weakness, felt like she was getting depressed, something wasn't right mentally, it wasn't right in her head, she felt like she can't. On Monday i.e. 25Jan2021 she was driving, 30mph and her brain was telling her to press the pedal. There was a delayed response to do the actual action, while driving down the road doing 30 in a 45, she wanted to speed up, but she couldn't connect the thought to switch the action, and it was the same thing when she got home, she wanted to pick up the remote, but it was putting the thought to the actions she couldn't do, she was just not herself. She had experienced loss of appetite, pressure in the back of her head, like when she was getting ready to make any type of motion or walk, her equilibrium was off. Her equilibrium being off depends on how much pressure was in the head, how much she felt it, to determine if her equilibrium is off, and was been varying. It is not the same all the time. She took off work on Tuesday i.e 26Jan2021 hoping she needed more rest. She went to the doctor on Wednesday i.e 27Jan2021, and the doctor thought maybe she had some tension from receiving the shot. It wasn't getting any better. She was due to get her next shot (second dose) and she asked if anyone else had these symptoms and if so how long did they last. She was trying to not take herself the second shot, she likes to travel and is trying to be brave for her children, and she works around soldiers everyday, the reason she got it is to protect her family, but she doesn't want to feel like this after the second shot. She had been 22 years in the army and had gotten many vaccine. she went into work on monday i.e. 01Feb2021, and haven't been back, covid test was negative. Hoping by monday i.e. 01Feb2021, she would be better. The patient underwent lab tests and procedures which included sars-cov-2 test as negative on an unknown date. The outcome of the events fatigue, asthenia and decreased appetite was not recovered/not resolved and for all other events it was unknown. Information on Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
50 2021-05-28 pain in extremity she had allergic reaction; Rash under her breast is, all over chest, back, and sides and it has move... Read more
she had allergic reaction; Rash under her breast is, all over chest, back, and sides and it has moved up into her hairline; fever; achiness; body aches; sore arm; Massive headache; loss of appetite; extremely tired; Chills; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: EL9269) via an unspecified route of administration on 06Feb2021 at 12:30 (at the age of 50-year-old) as a 1st dose, single dose in left arm for COVID-19 immunisation in School/Student Health Clinic. The patient's medical history included allergic to sulfa products taken for bad kidney, bladder infections 30 years ago; flu shots every year in the Fall around September or October and experienced soreness in arms, achiness and never had any other reactions and had COVID virus infection back during the end of the year. Concomitant medications were not reported. On 06Feb2021 Saturday night, the patient experienced sore arm and it was hard to lift like when she had flu shots in past. On 07Feb2021 Sunday, the patient experienced fever, achiness, body aches. The patient felt fine on 08Feb2021 Monday. Later on 08Feb2021, she experienced rash under her breast is, all over chest, back, and sides and it has moved up into her hairline. It does not itched, but irritating under her breast. On 09Feb2021, the patient went to urgent care, visited doctor in physician office and told she had allergic reaction and to not get the second dose, it could turn into anaphylaxis. On an unspecified date in Feb2021, the patient experienced massive headache, chills, loss of appetite, and was extremely tired. Patient enquired whether sulfa products is present in the Pfizer Biontech vaccine, as Sulfa is the only medicine she has been allergic to. The patient underwent lab tests and procedures included SARS-CoV-2 antibody test: unknown result on an unknown date. The clinical outcome of all the events was not recovered. Follow-up attempts are completed. No further information is expected.
50 2021-05-31 hot flush, night sweats Per patient, reported on 06/01/2021, she has been having increased episodes of menopausal sx (i.e. h... Read more
Per patient, reported on 06/01/2021, she has been having increased episodes of menopausal sx (i.e. hot flashes "every 5-10 minutes" and night sweats) since receiving 2nd Covid vaccination on 04/01/2021. Prior to vaccination, patient states symptoms "were under control."
50 2021-05-31 night sweats fever, chills and night sweats
50 2021-05-31 pain in extremity, burning sensation A few minutes after injection felt a burning sensation in face and ears. Felt tired that evening ... Read more
A few minutes after injection felt a burning sensation in face and ears. Felt tired that evening with muscle aches and sore arm. The next morning work up with intense body aches, headache, diarrhea and nausea. Have had diarrhea, nausea and tired for now for (4) four days. Cannot eat without having diarrhea and a general unwell feeling. I called my doctor who said that it?s unpleasant vaccine systemic side effects and to take Imodium AD and Tylenol. Go into the office if it does not resolve in a week. This seriously has me reconsidering the second dose.
50 2021-05-31 pain in extremity having trouble breathing, arm hurts, entire body aches
50 2021-05-31 tremor, weakness multible events shoulder injury tremors throughout her body body aches blood circulation problems sh... Read more
multible events shoulder injury tremors throughout her body body aches blood circulation problems she has seen multible doctors neurologist cardiologist gastro were as the doctors feel the vaccination has triggered these series of events that is dibilitating her body.she has not been able to work since inception of covid vaccination.
50 2021-06-01 numbness, tingling right arm/hand felt very tingly and numb briefly; right arm/hand felt very tingly and numb briefly; ... Read more
right arm/hand felt very tingly and numb briefly; right arm/hand felt very tingly and numb briefly; felt some chest discomfort; Gerd; indigestion; I had diarrhea; This is a spontaneous report from a contactable Other-HCP. This 50-year-old (non-pregnant) female other-HCP reported for herself that she received bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EM9810), dose 1 via an unspecified route of administration, administered in Arm Right on 13Feb2021 11:30 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included asthma, rubber sensitivity and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included tetanus vaccine taken for an unspecified indication as tetanus (vaccine 4 week/1 day prior) and Vitamins NOS for an unspecified indication start and stop date were not reported. Patient don't have covid prior vaccination. The patient experienced felt some chest discomfort, Gerd (gastrooesophageal reflux disease), indigestion and i had diarrhea on 13Feb2021 13:30 and right arm/hand felt very tingly and numb briefly on 17Feb2021. Reported as when I initially had the vaccine, I felt some chest discomfort that later felt like Gerd/indigestion. Then 2 hours later and several times throughout day I had diarrhea. 3 days after my right arm/hand felt very tingly and numb briefly. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 01Mar2021, sars-cov-2 test: unknown result on 01Mar2021. Patient had not received any treatment for the events reported. The outcome of the events was resolved on an unspecified date. No follow-up attempts are possible. No further information is expected.
50 2021-06-01 numbness Numbness (down arm to thumb), heaviness, itching and persistent radiating pain in posterior deltoid ... Read more
Numbness (down arm to thumb), heaviness, itching and persistent radiating pain in posterior deltoid and scapula. Discomfort is still present at time of completing this report (2 months post injection), currently in physical therapy (6 sessions completed.)
50 2021-06-01 pain in extremity 1st shot in right arm. After 24 hrs sore arm then intense headache on right side. Took 200mg Advil... Read more
1st shot in right arm. After 24 hrs sore arm then intense headache on right side. Took 200mg Advil. Very tired with intense lack of focus. Mental cramps on 5th & 6th days. Most symptoms lasted 2 weeks. 2nd shot 05/06/2021 in AM in left arm. 2nd day started having pain in chest on left side, lungs heavy, like couldn't catch breath, very weak in the knees and very tired. I am a non-smoker, healthy, only take vitamins and only have an occasional drink with alcohol 1x or 2x per week.
50 2021-06-01 pain in extremity Continue pain that jabs and throbs at all times of the day, every day for weeks now. Since getting t... Read more
Continue pain that jabs and throbs at all times of the day, every day for weeks now. Since getting the 2nd dose. The pain generates into the shoulder and rest of the arm.
50 2021-06-02 pain in extremity, feeling of body temperature change heart rate elevated; muscle pain; blood cell counts abnormal; equilibrium off; Blurred vision; Diarr... Read more
heart rate elevated; muscle pain; blood cell counts abnormal; equilibrium off; Blurred vision; Diarrhea; felt sick all day; sinuses feel off; pressure from headaches; Feeling hot and cold; Chill; fever 101.7 up to 103/ fever 103°F; foggy; Nauseous; tired; Light-headed; pain in arm; couldn't sleep; pain in arm; couldn't sleep; left arm sore and inflammed; swelling; headaches; This is a spontaneous report from contactable consumer (patient) or other non HCP. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch number/Lot number: EW0162, Expiration date: unknown), via unspecified route of administration in arm left on 09Apr2021, at 1ST DOSE, SINGLE for COVID-19 immunization. Patient medical history included ongoing prediabetic , Chronic sinusitis on unspecified date in 2014 and patient had undergone sinus surgery on unspecified date in 2014, COVID-19, acid reflux, patient had family history of father had a heart attack and mother had a heart attack and they are both diabetic. Concomitant medication included pantoprazole (PANTOPRAZOLE) on unspecified date at 2021 to ongoing for acid reflex which was diagnosed years ago, but has been actively taking for 3 months until now, multivitamin on unspecified date. Patient did not received any other vaccines Prior to that Vaccinations within 4 weeks. Patient had no know illness at the time of vaccination. 09Apr2021 patient experienced headaches, Light-headed, pain in arm; couldn't sleep, left arm sore and inflammed; swelling, on 10Apr2021 patient experienced chills, fever 101.7 up to 103/ fever 103°F, foggy, Nauseous, tired, Diarrhea, felt sick all day, sinuses feel off; pressure from headaches, Feeling hot and cold. on 12Apr2021 patient experienced equilibrium off, Blurred vision. on an unspecified date patient experienced heart rate elevated, muscle pain, blood cell counts abnormal. Patient reported that she had her Pfizer BioNTech vaccine on Friday 09Apr2021 and has had some serious side effects. patient wants to understand why she had such bad side effects compared to other people. Husband and other people she knows didn't have any side effects and she did. She states her next shot on 30Apr2021 and when she got the Pfizer COVID-19 vaccine, she felt fine as stayed the wait time at the facility but got lightheaded when she got to her car. She reported that on 09Apr2021 she had the lightheadedness comes and goes and she also experienced a headache and her arm soreness inflammed; swelling on 09Apr2021 in Friday. She reported that her arm pain was so bad that she couldn't not sleep. She could not lay on it. she states it is a little better now, it still hurts, but she is able to roll off of it and get some sleep. Patient experienced chills and a fever from 101.7 up to 103 degrees and Feeling hot and cold on Saturday 10Apr2021. she stated that she was taking Ibuprofen for pain and fever, and was told she shouldn't take Ibuprofen, she should take Tylenol to break the fever and she took some Tylenol and her fever broke after taking Tylenol. Patient stated that on 10Apr2021 she had also felt foggy, nauseous and tired. She reported that she had COVID in Jun2020 and felt like COVID all over again. she had the same symptoms; really tired, could sleep for days. patient thinks she had a bit of an allergic reaction on her arm. It has improved, but now she has a red swollen splotch on her arm, and it is not even where they put the needle it is down a little bit lower. Patient reported that her heart rate was elevated as well. Patient reported that 12Apr2021 she felt like equilibrium is off, and had blurred vision, feels fine right now, but all she has done was slept since she got home from work yesterday and hasn't exerted herself today yet and right now she is not tired, she slept for 12 hours. Patient reported that she felt sick all-day and had diarrhea on 10 Apr2021 in Saturday, nausea started on Saturday, all she could eat was chicken noodle soup and she experienced it yesterday. she states yesterday she took some Tylenol, and got a chicken sandwich, since she had taken some medication, and then wanted to throw it up when she got home and she is not foggy now, but it comes and goes, the symptoms are intermittent, she doesn't know if she will be ok. she can still feel on 10 Apr2021 her had sinuses feel off and she had chronic sinusitis and whenever she gets sick her sinuses get attacked. she states she didn't think she would get side effects because she already had COVID, but apparently it is the opposite. Patient reported that she was being told so many different things and now she was scared to get the second shot and is freaking out. she reported that she had to cancel all the appointments at work yesterday day because of the events and she thought she would have the weekend to recover from any side effects but couldn't do her job yesterday. Patient was not their in-Emergency Room nor visited physician office. It was reported that blood cell counts abnormal, so her doctor has her going to see a hematology doctor on Thursday. It could be nothing but sending there to check. The patient underwent lab test and procedure which include blood cell counts abnormal on 10 Apr2021 Outcome of events headache, chills, fever, foggy, nausea, tired, equilibrium off, Blurred vision, felt sick all day, sinuses feel off; pressure from headaches, heart rate elevated, muscle pain were unknown, light-headed, Diarrhea, Feeling hot and cold were not resolved, pain in arm; couldn't sleep, left arm sore and inflammed; swelling, were resolving, Follow up (13Apr2021): This is a follow-up spontaneous report from contactable consumer. A 50-year-old female patient reported new information received which included event detail, relevant medical history, concomitant medication. No Follow-up attempts are needed. No further information is expected
50 2021-06-02 tingling Developed paresthesia (tingling, pins and needles) in legs and arms, intermittent, moves around; mor... Read more
Developed paresthesia (tingling, pins and needles) in legs and arms, intermittent, moves around; more predominant in feet and hands; tender left supraclavicular lymphadenopathy (same side as vaccine administration); This is a spontaneous report from a contactable physician (patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6203), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:30 (at the age of 50 years old) as 2nd dose, single for COVID-19 immunization. Medical history included paraesthesia (10 years ago) lasting approximately 8 weeks, diagnostic evaluation was negative, self-resolved (no history of vaccination then), hypercholesterolaemia from an unknown date and unknown if ongoing. No known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included atorvastatin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 12:15 as 1st dose, single for COVID-19 immunization. 06Mar2021 13:00, the patient developed paraesthesia (tingling, pins, and needles) in legs and arms, intermittent, moves around and more predominant in feet and hands. The patient also had tender left supraclavicular lymphadenopathy same side as vaccine administration. The patient did not receive any treatment for the events. The clinical outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
50 2021-06-03 burning sensation, pain in extremity, tingling a painful lump on left pointer finger formed 4 days after vaccination & worsening 1 week later (soli... Read more
a painful lump on left pointer finger formed 4 days after vaccination & worsening 1 week later (solid bump with no pus); a painful lump on left pointer finger formed 4 days after vaccination & worsening 1 week later (solid bump with no pus); aggravated asthma (chest tightness); Body drug rash (swelling and pinkish skin color but no hives/welts); hands/fingers red; hands/fingers red hot/tingling/burning sensation; hands/fingers red hot/tingling/burning sensation; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm as a single dose on 10Mar2021 at 09:45 hours (at the age of 50 years), for COVID-19 immunisation. The medical history included breast cancer since 2008, hernia, asthma and migraines. The patient was allergic to PEG (polyethylene glycol). The concomitant medications included vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN) and DYMISTA. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 11Mar2021 at 09:00 hours, the patient experienced body drug rash (swelling and pinkish skin colour but no hives/welts); hands/fingers red hot/tingling/burning sensation and also aggravated asthma (chest tightness). On 15Mar2021, the patient experienced a painful lump on left pointer finger formed 4 days after vaccination and worsened 1 week later (solid bump with no pus). The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The patient received antihistamines (unspecified) and cortisone 2.5% inhaler as treatment for the adverse events. The clinical outcome of all the events body drug rash, hands/fingers red hot/tingling/burning sensation, aggravated asthma and painful lump on left pointer finger was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-06-03 flushing Mild joint achiness, face flushed/feverish for several hours. Some fatigue.
50 2021-06-03 numbness patient reported swelling, knot in neck, right sided facial numbness. Injection site redness/sorenes... Read more
patient reported swelling, knot in neck, right sided facial numbness. Injection site redness/soreness. Also reported severe reactions to first dose Pfizer COVID 19 Vaccine (severe headache, muscle pain, injection site redness)
50 2021-06-03 numbness The patient reported facial numbing for about 10 minutes, as well as head/clavical pain that lasted ... Read more
The patient reported facial numbing for about 10 minutes, as well as head/clavical pain that lasted hours, and a swollen lymph node and that lasted a day.
50 2021-06-03 pain in extremity Muscle weakness, extreme pain in joints, legs, feet, ankles, arms, shoulders, elbows, fingers, lower... Read more
Muscle weakness, extreme pain in joints, legs, feet, ankles, arms, shoulders, elbows, fingers, lower back and hips. Also, Erythema nodosum rash
50 2021-06-05 pain in extremity Patient felt pain right on the injection site when the vaccine was administered. The pain persisted ... Read more
Patient felt pain right on the injection site when the vaccine was administered. The pain persisted and extended to the whole arm in the next few days. There was no redness or swollen tissue. Now, after 1 month since the shot, the pain is not going away. After tried some OTC pain medications, Patient still feels pain all the time, and it affects her daily movements also, i.e. reaching out or driving, and this is the reason patient came back now to report the issue.
50 2021-06-06 pain in extremity, fibromyalgia, weakness, nerve pain Day after vaccine - chills, fever, achy joints - that lasted just a day or not quite. About a month... Read more
Day after vaccine - chills, fever, achy joints - that lasted just a day or not quite. About a month later- it kicked up my fibromyalgia. Nerve pain in my right arm; fatigue. My right knee and ankles get pain - so those were painful - but the arm pain was worse and it was aggravated by using it. My strength is much less in my arm right now. I had it about 10 years ago - I had it for about 8 years and then it went away in 2009 or 2010 and I haven't had it sense until now. If I need to I take Ibuprofen 800, I take it. I upped the dose of Metoprolol. It also made me other chronic conditions a little worse. I still get days when the symptoms are worse than they use to be. I spoke to a doctor at work. The fatigue is getting better. And I can walk and get up out of chair etc - last time it happened to me for those 8 years, it was much worse. It is about 1/4 of what I experienced last time.
50 2021-06-06 tingling, numbness Tingling/numb feeling on left side of face only. Forehead, cheek, left eye, left side of my lips.
50 2021-06-06 seizure Multiple seizures, went to ER, lost complete memory for 18 hours, 3 day hospital stay, loss of drivi... Read more
Multiple seizures, went to ER, lost complete memory for 18 hours, 3 day hospital stay, loss of driving privileges for 90 days, on Keppra for seizures and on Eliqios for blood clot near the lung.
50 2021-06-07 pain in extremity This is a spontaneous report from a contactable consumer (reporting herself). This 50-year-old femal... Read more
This is a spontaneous report from a contactable consumer (reporting herself). This 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8729), via an unspecified route of administration in left arm on 14Apr2021 at 14:00 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included migraines (she takes migraine medication as needed). The patient's concomitant medications were not reported. None of the additional vaccines administered on same date of the Pfizer suspect. The patient received no other vaccination with 4 weeks of COVID vaccination. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7537, ER7534 or ER753U (lot number was handwritten on her vaccine record card, and she cannot read the last character), via an unspecified route of administration in left arm on 24 Mar 2021 at 14:00 as a single dose for COVID-19 immunization and experienced her arm was sore, Her period stopped after she got the covid vaccine and It has been almost 80 days, and she is still having extreme pain, in every part of her joints. On an unspecified date in Apr2021, the patient was experiencing joint pain throughout her body, was worse right after the vaccine but has gotten better but still experiencing pain, was wondering if this was a side effect of the vaccine. States she has already spoken with the safety department. On 15Apr2021, the patient's top left ear was in pain: Her ear was hurting on the same side she received the covid vaccine, her left side. Clarifies that her ear only hurt at the top, her cartilage part was what hurt. It was really odd, and very weird. It lasted for 4 or 5 days. On 15Apr2021, the patient's ear felt like it was burning and hurt painful. On an unspecified date in Apr2021, the patient was noticed a lymph node on the side of her neck on the same side she received the covid vaccine. On an unspecified date in Apr2021, every single point of her body hurt, every knuckle, finger and toe and it lasted about two weeks where it was very painful, but the patient still had it now. It began 2 or 3 days after she received the second dose of the covid vaccine. Now it has subsisted into feeling like a dull joint pain. Every point of her joints was weird, even padding of her feet hurt. Before her pain was a sharp joint pain. On an unknown date in 2021, the patient's having normal menstrual cycle till then but since receiving the vaccine she has not had one. She had spoked with her OB/GYN (obstetrics and gynaecology) and was advised to report to Pfizer, to which caller states she had already spoked with the safety department. The patient did not undergo any laboratory test. Event having normal menstrual cycle till then but since receiving the vaccine she has not had one resulted in Physician Office Visit. The outcome of the events Joint pain throughout her body, a lymph node on the side of her neck and every single point of her body hurt, every knuckle, finger and toe was resolving, top left ear was in pain and her ear felt like it was burning was resolved in Apr2021 and having normal menstrual cycle till then but since receiving the vaccine she has not had one was unknown. Followup attempts are possible, additional information has been requested.
50 2021-06-07 pain in extremity First dose: Her arm was sore; bruise; It has been almost 80 days, and she is still having extreme pa... Read more
First dose: Her arm was sore; bruise; It has been almost 80 days, and she is still having extreme pain, in every part of her joints.; Her period stopped after she got the covid vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7537), via intramuscular route of administration, administered in Left Arm on 24Mar2021 14:00 (at the age of 50-years-old) as 1st Dose, Single Dose for COVID-19 immunization. The patient's medical history included migraine, she takes migraine medication as needed. The patient's concomitant medications were not reported. The reporter stated that on an unspecified date in 2021, It has been almost 80 days, and she is still having extreme pain, in every part of her joints. On 25Mar2021, first dose: Her arm was sore: It lasted for three or four days. on an unspecified date in 2021, It hurt like a bruise would, but there was no bruise. on an unspecified date in 2021, her period stopped after she got the covid vaccine. Her period has always been really heavy. The patient last had her period a month before the covid vaccine. The patient thought she would let it be for a while. The patient went and saw her OBGYN (obstetrics and gynaecology), and he said that she could call Pfizer and report about it. Her OBGYN told her that a lot of women are having interruptions with their period, some women's periods are not coming back, or are coming back heavier. The patient's last period was 10Feb2021. The patient uses a period tracking app. The patient's period was 84 days late. The patient did not undergo any laboratory test. The event her period stopped after she got the covid vaccine included physician Office Visit. The outcome for the events was unknown. Follow-up attempts are possible, additional information has been requested.
50 2021-06-08 difficulty speaking, numbness, pain in extremity Wednesday, May 19, 2021 1st COVID-19 vaccination shot Summary: Wednesday, May 19, 2021 received my ... Read more
Wednesday, May 19, 2021 1st COVID-19 vaccination shot Summary: Wednesday, May 19, 2021 received my 1st COVID-19 vaccination shot. My body tried to reject it. I threw up 5 times. Ensued many unwanted side effects. I don?t think it would be good to get the 2nd vaccine dose. Given I am not fully vaccinated, I need an alternative solution to prevent being infected with the virus. Help!!!! Please Help!!! Bad Side Effects: Stuffy Nose Congested Nose Headaches Vomiting Nauseous Upset Stomach Unsettled Stomach Unusual Perspiration Pain in Left Arm Abnormal Period Menstrual Blood Clots Shoulder Pain/Tension Upper Back Pain/Tension Chest Pain/Tension Shooting Pain in Chest Heart Palpitations? Numbness Runny Nose Sneezing Profusely Allergies? Hoarse Voice Winded Dry Mouth Existing Worsened: Cold Sores Stomach Noises Snoring? Foot Numbness Ear Ringing Eye Floaters Joints Popping Sound Other Observations: Stomach Bloated Increased Flatulence Pseudo Conclusion: Given my body?s adverse reaction I don?t think it is wise to get the 2nd shot. It is obvious my body does not like it. I am disappointed because I really did not plan to get vaccinated; however, I felt I had no other option when the government made the announcement. When the government announced No masks for those vaccinated, I know there would be some NOT vaccinated & NOT wearing a mask thus putting me at risk. I am okay with wearing a mask for another year or even for the next 5 years. The doctors have said me wearing a mask is protecting others not necessarily myself. I concluded even if I continue to wear a mask there would be others (NO mask & NOT vaccinated) not following the rules potentially exposing me to the virus. Hence the only way to protect myself is to get vaccinated. The vaccine appears to have affected so many areas of my body. I regret getting the 1st shot, I want to remove every trace of it from my anatomy. Please let me know if it is possible to rid the vaccine along with all the bad side effects from my body. I do not want to subject my body to anymore of this vaccine; however, I still need a reliable solution to avoid being infected with the virus. I don?t know what to do. Details: Wednesday, May 19, 2021, I received my 1st COVID-19 vaccination shot around 3:30pm. The medical staff had all those being vaccinated to sit for at least 15 minutes for observation to be monitored. I stayed for monitoring for close to an hour (wearing my masks). I felt fine, I noticed my right nostril felt stuffy, congested with a slight burn sensation. I noticed a slight headache when I left. I had about 3 errands to do. 2 hours later I wasn?t feeling well. In addition to a stronger headache my stomach felt queasy. Around 6:30pm I had to pullover to vomit; I threw off my mask and threw up once and then a 2nd time. I sat in my car taking deep breaths until I felt I could make it home. I make it home around 7pm in time to throw up 3 more times, for a total of 5 times. The vomit tasted acidic, sour, citrusy, and metallic at times, and salty. I was only throwing up the vaccine it was mostly clear with white alka seltzer looking deposits. I last ate some crackers around 12 noon. Vomiting is NOT normal for me. I can?t remember the last time I threw up, many many many years ago. l had a headache, queazy stomach, and was exhausted; about 7:30pm tried to sleep. I got up around 10:30pm ate a few saltines and drank a little water but I still didn?t feel good so I didn?t eat anything else. Rough night trying to sleep, tossing and turning. Next day (Thursday day 2) I felt slightly better, not comfortable enough for real food so I drank plenty of water in small amounts and ate saltines; headache subsided. I also had more than usual underarm perspiration with a strong unfamiliar odor. Wednesday, May 19, 2021 1st COVID-19 vaccination shot It appears the vaccine affected my menstrual cycle. My period usually lasts for 3-5 days max, usually light blood flow on days 4 and 5. It was a normal light day 5 when I received the vaccine. After the vaccine, I began having heavy blood flow. The heavy blood flow is accompanied by blood clots. In the past I?ve had a blood clot here and there but not like this. Menstrual blood clots for 9 days after being vaccinated. This is NOT normal for my body. My period was 14 days. Prior to being vaccinated, I NEVER had a period last this long. To my surprise the vaccine affected my female organs. I am right handed, so the nurse recommended using my left arm for vaccination. Left arm where vaccine injected was very sore. Arm pain subsided after 3 days. Pain soreness tension primarily on my left side, shoulder, upper back, chest area. There is a shooting pain on left shoulder, down back to breast, chest heart area; pain comes and goes. Heart palpitations? Experienced this for over a week about 10 days. Numbness in left hand when I sleep on my left side, wake with my left hand numb. Numbness in both hands when I try to sleep on my back. Numbness in my feet after standing for about 15 minutes. Numbness in my leg and buttocks, primarily left side after sitting for an extended period of time. Before being vaccinated I only experienced numbness in my right foot after being on my feet for an extended period of over 4 hours. Last year my right foot/heel would began to hurt after being on my feet for an extended period of time (> 4 hours). Then there would be pins and needles sensation. The solution would be to rest and elevate my feet. I also replaced my shoes (proper support). Post vaccination even before the time my feet would hurt now my right foot goes numb within 30 minutes of standing even while wearing supportive shoes. My left butt cheek goes numb when I am sitting with my legs elevated; this was my most comfortable position pre-vaccination. Since the vaccine my stomach feels upset or unsettled especially in the morning. I am also noticing bloating and more gas than usual. My stomach is also excessively more noisy. Before the vaccine my stomach would make noises when I was hungry or hadn?t eaten, but now there are so many stomach noises almost nonstop all day and night long all the time My nose is feeling congested with a slight burn sensation since getting the vaccination. Immediately after getting the shot my right nostril felt stuffy, congested with a slight burn sensation. This congested feeling comes and goes, especially noticeable when wearing a mask. Prior to being vaccinated I had not experience this issue even as I have worn multiple masks for over a year with NO stuffy nose. Saturday, May 29, 2021 (day 10 post vaccination) I get cold symptoms; runny nose and sneezing. I haven?t had a cold in years; I don?t really get colds; if so the symptoms are mild and quickly dissipate. Now my nose has been running pretty much non-stop causing me to blow my nose just as often. I am also sneezing a lot. This is NOT normal for me. I drank plenty of liquids; however, running nose and sneezing continued leading to hoarse voice. These symptoms prevented me from sleeping. I don?t know if these are cold or allergy symptoms. I had NO allergies before the vaccine. These symptoms finally subsided after 3 or 4 days. My neighbors are waking up in the middle of the night (2am, 3am, 4am, 5am). I began to wonder if I am waking my neighbors possibly with snoring. I don?t really know, no evidence. Throat feels winded and dry when talking especially when I try to whisper. I have to drink a lot of water. Ringing in my ear started In 2019. I thought this phantom sound went away; however, post vaccination I?m hearing the ringing sound again. It seems worse than before. 2018 diagnosed with eye floaters. I am noticing floaters more since getting the vaccine. I usually see the eye floaters when going to light from dark. Post vaccination I am noticing the floaters even in dim light; not normal. I started getting Cold sores in 2006. I thought I had them somewhat under control. Since the vaccine l keep getting cold sores, this may be due to my menstruation. Recently within the past year, my shoulder and elbow joints sometimes make this popping sound when I exercise/move my arm. Post vaccination my shoulders and elbows are making the popping sound every time I move my arm. Now sometimes my knees and ankles are also making a popping .
50 2021-06-08 feeling hot, feeling cold, tingling, tremor Ok I was in bed and I feel terribly like warm inside my body but outside my body, I was shaking and ... Read more
Ok I was in bed and I feel terribly like warm inside my body but outside my body, I was shaking and froze. My brain was telling me to move but I could not move. I called my husband for help and I could not move my body. I had him go get some Advil that I took then I checked my temperature and it was over 100, I don't remember exactly. And it took like 1 hour I tried to get up but I could not, I felt so dizzy and like I going to vomit. So I went back to bed and I got up two hours later and when I get up, I felt so totally blocked and dizzy, kind of seasick feeling. I sat down because I could not walk, I was so shaking. I kept trying to get up and after 3 attempts I was able to go to the bathroom and when I did I had diarrhea and vomiting but that was mainly saliva not food. I drank a lot of water to hydrate and wash it out. When I drank some water it also came back out. My body was like it did not want to take anything in. My fever was going down in another day, but I had to call into work. I was in bed for another day. I was still very warm inside but shivering and cold. My muscles also felt tingling and tight and uncomfortable. The next day I called into work again. On the 3rd day I had no more fever and had some muscle pain but did not feel warmness inside but am still shaking a little bit.
50 2021-06-08 muscle spasms Developed common side effects fatigue, aches and headache day 2. Day 6 developed severe temporal hea... Read more
Developed common side effects fatigue, aches and headache day 2. Day 6 developed severe temporal headache with palpable temporal scalp tenderness and neck ache with severe sleep disturbance lasting 3 days. After injection 2 developed similar but more symptoms day 5. Subsequent development of occipital neuralgia on left increasing frequency and duration with associated severe insomnia and chronic muscle spasms of neck, shoulders and chest. Also developed intermittent muscle cramps in legs, biceps and triceps as well as short lived muscle fasciculation. Treated with tizanidine, Medrol dose pack, Celebrex and massage with no relief. Occipital nerve block on 5/28 relieved occipital neuralgia but developed severe spasm of neck, shoulders, upper back and chest being treated with PT with reported mild improvement.
50 2021-06-08 pain in extremity bleeding from scratching the itching rash of the allergic reaction.; Allergic reaction; night itchin... Read more
bleeding from scratching the itching rash of the allergic reaction.; Allergic reaction; night itching; itching rash/rash all over her body; Pain in her arm and ankles; Pain in her arm and ankles/ pain in her ankles, on the bottom part of her legs around her ankles, very bad pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 50-years, on 15Apr2021 15:00 (Lot Number: CW0151) as single dose; then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in right arm at age of 50-years, on 07May2021 (at 12:30-12:40) (Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history included allergy to shellfish. The patient's concomitant medications were not reported. There was no other vaccines administered on same date with the Pfizer vaccine. There was no any other vaccinations within four weeks before or after the Pfizer Corona Vaccine. The patient previously took benadryl and experienced allergy (Doctor told her never to take Benadryl because she could die, could have anaphylaxis). The patient administered both doses of the Pfizer Corona Vaccine. She believed she was having a very bad adverse effect from the vaccine, an allergic reaction. She also reported having had pain in her arm and ankles the day of her second dose of Pfizer Corona Vaccine. Onset 2 days after the Pfizer Corona Vaccine, unable to clarify date further or if after the first or second dose of the Pfizer Corona Vaccine. She ate a lot of fruits and vegetables, she had been practically a vegetarian for a long time. Allergic reaction started little by little when she would eat; but now it occurred every time she ate. Usually she ate in the late afternoon so now when she ate a lot of fruits and vegetables she spent the rest of the night itching; she was tearing into her skin now, bleeding from scratching the itching rash of the allergic reaction. Ever since she had taken the Pfizer Corona Vaccine, every times she ate a lot of fruits and vegetables she seemed to be getting this rash all over her body that won't go away. It was scary, she was scratching and itching, starting to get worried because she was bleeding everywhere. She was afraid she may eat and get anaphylaxis. The patient had Hydroxyzine and asked if she can take Hydroxyzine for the allergic reaction. She wondered if her allergy to Benadryl could be part of the allergic reaction she was having. She had always had an allergic reaction to Benadryl which made her very nervous. She had to just flush herself, drink a lot of water to flush her system. About events Pain in arm and ankles: Time of onset unknown. Onset the first day (on 07May2021) when she took the second dose of Pfizer Corona Vaccine. She had very bad pain in her arm, could barely lift her arm, and also had pain in her ankles, on the bottom part of her legs around her ankles, very bad pain. The outcome of event Pain in arm and ankles was recovered completely by the following evening on 08May2021, of event allergic reaction was not recovered, while for remains events was unknown. No follow-up attempts needed. No further information expected.
50 2021-06-09 numbness, tingling Immedietly after shot she felt a pulling, numbing, tingly sensation from her shoulder, neck and arm.... Read more
Immedietly after shot she felt a pulling, numbing, tingly sensation from her shoulder, neck and arm. Subsequently, 5 days later was brought to ER with multiple feelings of illness unexplained. On 4/21/2021, was rushed to hospital with stroke like symptoms. Hospitalized 6 days cant fill in to right of this form
50 2021-06-10 feeling cold feel cold; body was shaking and couldn't seem to warm up; fever; This is a spontaneous report from a... Read more
feel cold; body was shaking and couldn't seem to warm up; fever; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6205) via an unspecified route of administration administered in left arm on 12Mar2021 at 08:00 (at 50 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included "thalacimia (Mediterranean anemia)" as reported, from unspecified date. The patient had no known allergies. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (Lot number: EN6205) via an unspecified route of administration administered in left arm on 19Feb2021 at 08:00 as single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. About 38 hours after the vaccine, the patient started to feel cold. Eventually, the patient was so cold her body was shaking and couldn't seem to warm up. Probably 3 hours later a broke a fever. All were non-serious on 13Mar2021 at 22:30. No treatment received for the events. Outcome of the events was recovered on unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.
50 2021-06-10 hot flush, flushing, feeling hot feeling very hot & flushed, very uncomfortable; feeling very hot & flushed, very uncomfortable; feel... Read more
feeling very hot & flushed, very uncomfortable; feeling very hot & flushed, very uncomfortable; feeling very hot & flushed, very uncomfortable; hot flashes; This is a spontaneous report from a contactable consumer or other non-health care professional. A 50-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 28May2021 20:15 as 1st dose, single dose for COVID-19 immunization. Medical history included thyroid disorder, high blood pressure from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, lisinopril taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within four weeks. The patient was not had Covid prior vaccination, and the test was not performed post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. On 29May2021 08:00 am, the patient reported that in 8 days since received vaccine I have been feeling very hot & flushed, very uncomfortable. It is warm out but even at night when 50s or 60s, still feel like I need a/c running. I am of the age to have hot flashes but never had them prior to this shot and this hot feeling has been rather continuous over the last 8 days, starting right after the shot, with no sign of slowing down. The events were assessed as non-serious. Treatment was received for the events. The patient had no known allergies. The outcome of the events was reported as not recovered. Information about lot/batch number has been requested.
50 2021-06-11 pain in extremity Patient said her arm was in a lot of pain, said there was some bleeding around the area (unclear if ... Read more
Patient said her arm was in a lot of pain, said there was some bleeding around the area (unclear if bleeding persisted after the patient left the pharmacy)
50 2021-06-12 pain in extremity Pain left arm and hand 30 seconds post vaccine. Left arm and left axilla swelling and pain 6 hours ... Read more
Pain left arm and hand 30 seconds post vaccine. Left arm and left axilla swelling and pain 6 hours after vaccine. Lymphadenopathy left axilla 6 hours post vaccine. Diarrrhea with blood 6 hours post vaccine. All symptoms have persisted for 3 days. No fever.
50 2021-06-13 weakness Employee stated after receiving the second dose of the Pfizer COVID-19 vaccine, she felt weak, was a... Read more
Employee stated after receiving the second dose of the Pfizer COVID-19 vaccine, she felt weak, was achy all over, and had a low grade fever of 100.8. Employee stated that she alternated taking Tylenol and Motrin for the aches and fever. The symptoms subsided after 2 days. The symptoms did not interfere with ADL's.
50 2021-06-13 numbness immediate headache and numbness in left arm sick for a week went to diabetic doctor and obgyn and ha... Read more
immediate headache and numbness in left arm sick for a week went to diabetic doctor and obgyn and have labs to be drawn
50 2021-06-13 tingling, muscle spasms Tingling of mouth and tongue with subsequent swelling of tongue. Swelling of tongue lasted most of t... Read more
Tingling of mouth and tongue with subsequent swelling of tongue. Swelling of tongue lasted most of the evening. I treated the swelling with 5-6 doses of Benadryl throughout the evening. Tingling of mouth lasted for several days, then resolved and returned intermittently over the course of about 2 weeks. Within 2 days of the vaccine I developed a rash across most of my back that resolved after about a week, then returned to a milder extent about a week after initial resolution. A few days after the rash, I started experiencing tingling of my lower extremities that woke me up, that progressed to cramping of the legs. This occurred for several nights. My tongue continues to have a low level of tingling that has not gone away. I notified my PCP of the event, but have not visited as there is not likely anything to be done and the majority of the symptoms with the exception of tingling of the tongue have resolved.
50 2021-06-13 tension headache After the first Pfizer vaccine I experienced a severe headache lasting a week which required schedul... Read more
After the first Pfizer vaccine I experienced a severe headache lasting a week which required scheduled tylenol (1000mg) and ibuprofen (600mg) tapered to reduce the intense headache. Ice and rest for the week (5 days) was also required. My ADL's were not able to be completed due to the intensity of the headache. The second vaccine there were no symptoms to report but since this vaccine I have re-occurring severe headaches that require tylenol and ibuprofen, rest and ice. This is a new onset since this vaccine that I have not had in my entire life with no history of headaches. These headaches have caused me to contact a virtual physician which advised me to report to the emergency room due to it causing right eye drooping. I also recently went to my PCP regarding these headaches which he stated that they are "tension" headaches, at my age new onset of migraines is not common. My lifestyle does not support "tension" headaches and in my opinion are a long term side effect from the vaccine.
50 2021-06-14 night sweats 1 week after shot. Sore chest muscles, ear ringing, severe anxiety, winded easily, racing heart, hea... Read more
1 week after shot. Sore chest muscles, ear ringing, severe anxiety, winded easily, racing heart, heart palpitations, fast pulse with minimal activity. Waking in night with rapid pulse 140BPM, resting pulse between 90-110. Headache, severe muscle aches and night sweats. These severe symptoms lasted two weeks. Symptoms slowly have been subsiding, but it took nearly two months. Still have a slightly elevated resting heart rate. Other than that, feel fully recovered. Very scary experience! Grateful to be vaccinated though.
50 2021-06-15 numbness, flushing After the vaccine was given, my heart began racing and I felt flush. I felt like the room was spinni... Read more
After the vaccine was given, my heart began racing and I felt flush. I felt like the room was spinning. The pharmacist took my blood pressure and it was 228/128. My heart rate was 122. My blood pressure is always 120/60. I was trying to call my husband but the room was spinning and I felt like I was going to throw up. I was flushed and my arms and legs felt numb. I was gasping at air because it felt harder to breathe. I tried to stand but had to sit back down. My blood pressure went down after 15 minutes but was still elevated. My heart rate has stayed high. I finally left and when I made it home, I threw up all night. My heart is continuing to be above 100. It has been racing for the past two days. I woke up the past two nights with spitting headaches and my heart rate at 113, 110. I am dripping in sweat both nights which has never happened to me. My glands are now swollen as well and I still feel lousy two days later.
50 2021-06-15 pain in extremity, night sweats Within 24 hours felt fatigued and arm soreness, mild body aches. Within one week felt joint pains wh... Read more
Within 24 hours felt fatigued and arm soreness, mild body aches. Within one week felt joint pains which are ongoing (wrist, knees). Fatigue continues to -date and is not improving. Taking daily naps and not feeling rested. Feel in a fog and constantly tired. Occasional headaches. Congestion for the last 3 weeks and mild dry cough. No fever. Hot flashes worsened. Night sweats have worsened. Fatigued and lethargic continues
50 2021-06-15 tingling, numbness The first thing I experienced was numbness and tingling on the left side of my face and excessive wa... Read more
The first thing I experienced was numbness and tingling on the left side of my face and excessive watering and irritation in my left eye as well as some pain on the top of my head n the left side. I also had very swollen lymph nodes in my neck on the left side. This lasted for a while. I saw a doctor about it about a week after it. I had dangerously high blood pressure. They sent me home with medication and told me to go to the ER if I had any chest pains. As for the tingling, they initially thought it was shingles. I had some bumps that were painful at the top of my hairline in the left side. I was given something to put on that. I was also sent to the ophthalmologist because my eye was still continuously watering, The tingling went away after another week or so. The swollen lymph nodes came and went for about a month. My eye still continues to have problems. Eventually the ophthalmologist guessed that I had shingles which was probably triggered by the vaccine. I am currently taking a steroid drops in my left eye.
50 2021-06-16 muscle twitching twitch on the left-hand side of my face, ran from my left cheek bone to the left corner of my mouth.... Read more
twitch on the left-hand side of my face, ran from my left cheek bone to the left corner of my mouth.; This is a spontaneous report received from a contactable consumer, the patient. A 50-Year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) as a single dose via an unspecified route of administration in her left arm on 10Mar2021 at 12:30(at the age of 50-years-old), for COVID-19 immunisation. The patients medical history included high blood pressure and herpes. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had received other medications within 2 weeks of vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient had reported no allergies to medications, food or other products. The patient had not diagnosed with COVID-19 prior to vaccination. The patient reported that she did not have any side effects immediately, but she woke up friday morning with a "twitch" on the left-hand side of her face, it ran from her left cheek bone to the left corner of her mouth on 12Mar2021at 07:00 hours. It was just an involuntary spasm on that side of her face, she did not have any drooping, it was just an annoyance, it persisted for about six days, she woke up on the 7th day, and the symptoms had almost completely subsided. The patient did not receive any treatment for the reported events. The clinical outcome of the event twitching was recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
50 2021-06-16 pain in extremity injection site pain; my neck was stiff 2 days after receiving my second dose; my left arm began to b... Read more
injection site pain; my neck was stiff 2 days after receiving my second dose; my left arm began to become sore as if it had been injected into the left arm again; This is a spontaneous report from a contactable Nurse reported herself. A 50-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Right on 30Jan2021 at 18:30, (at the age of 50 year and patient was not pregnant at the time of vaccination) as 2nd dose SINGLE DOSE for covid-19 immunisation at hospital. Medical history included hypertension, type 2 diabetes mellitus from an unknown date and unknown if ongoing, covid-19 and musculoskeletal stiffness from Nov2020 to an unknown date. Patient had known allergies. The patient's concomitant medications were not reported. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. Patient's historical vaccine includes first dose of BNT162B2 via intramuscular, administered in Left arm on 06Jan2021at 12:00 PM for COVID-19 immunization and experienced the event vaccination site pain and left arm began to become sore. The patient experienced my left arm began to become sore as if it had been injected into the left arm again on 30Jan2021, injection site pain and my neck was stiff 2 days after receiving my second dose on 01Feb2021 at 13:00. It was reported that, she received 1st vaccine in left arm and second in right arm. About 10 minutes or so after receiving the second vaccine, my left arm began to become sore as if it had been injected into the left arm again. That went away later that night. She started injection site pain the next day which lasted only a few hours, while with the 1st injection it lasted 3 or 4 days. This afternoon she noted that neck was stiff 2 days after receiving my second dose. The only reason mention that was when she was sick with covid-19 in November, the stiff neck was one of the first symptoms noticed. Since vaccination patient not tested for covid-19. Therapeutic measures were not taken as a result of the events. The outcome of the events was reported as not recovered. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
50 2021-06-16 pain in extremity Pt received first dose on vaccine and pt complains of sore arm. Pt states a couple days later she st... Read more
Pt received first dose on vaccine and pt complains of sore arm. Pt states a couple days later she started to get headaches on and off. Pt states then she started to have body aches on and off. Pt states that if she takes medication the headaches go away. Pt hasn't felt quite right since receiving the first dose of the vaccine. Pt states that she has a very over active immune system. Pt is unsure if headaches are because of stress or not.
50 2021-06-16 pain in extremity Slightly sore arm after first dose; This is a spontaneous report from a contactable consumer or othe... Read more
Slightly sore arm after first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204, expiration date were not reported), via an unspecified route of administration, administered in the left arm on 25Mar2021 10:45 (at the age of 50-years-old), as first dose, single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced slightly sore arm after first dose on an unspecified date. Treatment was not given as a result of the event. The outcome of the event was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.
50 2021-06-16 pain in extremity COVID-19 PCR test positive; they had a sore arm that day that went away with no side effects.; This ... Read more
COVID-19 PCR test positive; they had a sore arm that day that went away with no side effects.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8732) via an unspecified route of administration on 08Apr2021 at 07:00 pm on left arm as 1st dose, single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient reported that three out of four of her family got the first dose of the vaccine then tested positive for COVID-19 on 20Apr2021. Her husband went in related to his allergies to get tested. She says it was her mother-in-law that had passed, then Tuesday they all got tested and they were all negative. She says her husband started feeling like he had allergies Friday after he cut the grass, and her son is a crazy person about COVID, but he has asthma so he wanted them to all get tested again since allergies can be like COVID, and her husband's test was positive, so then she and her son got tested and they were positive, so they had three positives out of the four family members who got the first dose. She clarifies that her mother-in-law didn't get the vaccine, but she had passed away Tuesday, and they contracted COVID during that time after she passed away at home. They had not gotten any other vaccinations the day of the first dose of the COVID-19 vaccine or in the four weeks prior. Their second dose is scheduled on 29Apr2021, he would like to know if they need to get tested and test negative for Covid-19 before receiving the second dose of the vaccine. They told her May 4th was when they could get their second dose after quarantining. She says that they were all fine after they got the first dose of the vaccine, they had a sore arm that day that went away with no side effects. She says that her arm soreness began that night into the next day, then it went away without treatment the next day after that, so lasting about 24 hours. She says she felt like if she had been able to move her arm after instead of how she slept on it at night, it would have been less, but she didn't get to move it around much since they got it at night. No follow-up attempts are needed. No further information is expected
50 2021-06-16 tingling, pain in extremity, feeling hot About 30 minutes after injection my arm began to tingle and felt warm on the inside. I figured it wa... Read more
About 30 minutes after injection my arm began to tingle and felt warm on the inside. I figured it was normal, so i ignored it. It continued for about an hour. The following day my elbow ached and was difficult to move, but i figured that might be normal as well. The day after that, i noticed a small lump forming on the muscle of my elbow and it became a bit more painful. I figured it would go away but instead, over the next few days the mass got larger, more painful and I could no longer straighten my arm. I have no insurance and have not been working full time so also had no money, therefore i could not go to a doctor. Several days later I tried to lift a tea pitcher and it felt like something in my arm ripped. I called an urgent care and was told that due to it being vaccine related, they could not treat me. I then went to the health department and was again turned away. My last recourse was the hospital ER. The doctor did an ultra sound and blood tests. She saw the swelling and bruising, she felt the mass under my skin, but could not explain any of them. Since then my arm has develoiped more masses and the pain has spread to the bicep, fore arm and under arm areas.
50 2021-06-16 tingling Tinnitus- since vaccine I?ve have a constant ringing in my ears , hard to fall asleep and then have ... Read more
Tinnitus- since vaccine I?ve have a constant ringing in my ears , hard to fall asleep and then have nighttime awakenings. Shortness of breath, chest pain, tingling of my left side of the face , fatigue.
50 2021-06-17 bell's palsy Bells palsy; I have severe low blood sugar where I pass out 3 or 4 times a month; I have severe low ... Read more
Bells palsy; I have severe low blood sugar where I pass out 3 or 4 times a month; I have severe low blood sugar where I pass out 3 or 4 times a month; After shot blood sugar went to 350! Fasting 220; I have severe low blood sugar where I pass out 3 or 4 times a month; This is a spontaneous report from a contactable consumer (reported for herself). A 50-years-old female patient received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW6206/Batch number was not reported), via an unspecified route of administration administered in the left arm on 03Jun2021 (at the age of 50-years-old) as unknown, single dose for COVID-19 immunization. Medical history included systemic lupus erythematosus from an unknown date and unknown if ongoing, ischaemia from an unknown date and unknown if ongoing and diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received cafeine and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced Bells palsy, she has severe low blood sugar where she pass out 3 or 4 times a month. After shot blood sugar went to 350, Fasting 220. She was always tested her blood daily for 10 plus years. She was still diabetic 3 months later and her blood sugar was extremely high. The reporter stated the events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood glucose abnormal: 350 on an unspecified date, blood glucose decreased: 220 on an unspecified date. Therapeutic measures were taken for the events with diabetic medication. The events Bells palsy, she has severe low blood sugar where she pass out 3 or 4 times a month assessed as serious (medically significant). The clinical outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
50 2021-06-17 burning sensation, muscle twitching, pain in extremity, tingling Parasthesia Extreme fatigue Burning in entire body Muscle twitching Chest pains Lower leg pain Low b... Read more
Parasthesia Extreme fatigue Burning in entire body Muscle twitching Chest pains Lower leg pain Low blood pressure High heart rate
50 2021-06-17 numbness and pain in extremities Got Peripheral Neuropathy in upper left arm, bruising everywhere
50 2021-06-17 pain in extremity Pfizer vaccine #2 ~10:10 AM 06/15/2021. ~3:00 PM gums felt inflamed. ~5:00 PM whole mouth inflamed/s... Read more
Pfizer vaccine #2 ~10:10 AM 06/15/2021. ~3:00 PM gums felt inflamed. ~5:00 PM whole mouth inflamed/swollen, sore tongue and top of throat. No trouble breathing. ~4:00 AM 06/16/21 awoke to stomachache and thick sinus congestion; blew nose, tissue full of bright red blood. ~9:00 AM 06/16/2021: tiny blisters on still sore tongue, inside lips slightly swollen but worst subsided. Pain under left arm (injection arm). 6/17/2021 AM: All symptoms subsided except pain in left underarm. 6/18/2021 AM: Stil pain under left armpit. NOTE: Normal reactions: slight elevated temp and headache x 2 days. Took no OTC meds to avoid antibody interference. Stayed hydrated. Oura Ring showed significant sleep interference x 2 days.
50 2021-06-17 pain in extremity The next day I have severe acid reflux and I don't have that normally; Severe runny nose; achey; chi... Read more
The next day I have severe acid reflux and I don't have that normally; Severe runny nose; achey; chills; really bad sore arm; This is a spontaneous report from a contactable other health care professional. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: El9265, Expiration date: Unknown) via an intramuscular route of administration in right arm on 02Feb2021 (at the age of 50-year-old) as UNKNOWN, SINGLE DOSE for Covid-19 immunisation. The patient medical history was not reported. No known allergies were reported. No known allergies were reported. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 02Feb2021 at 14:45, the patient had experienced severe runny nose, achey, and chills, really bad sore arm and on 03Feb2021, next day patient had severe acid reflux and don't have that normally. Patient did not receive any treatment for the events. The outcome of events was recovering at the time of reporting. Follow-up attempts are completed. No further information is expected.
50 2021-06-17 tremor Second dose: extreme chills; Second dose: fever; Second dose: temperature 101.4 degrees Fahrenheit; ... Read more
Second dose: extreme chills; Second dose: fever; Second dose: temperature 101.4 degrees Fahrenheit; Second dose: chills to the point she was shaking; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for herself (patient) a that 6-decade-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EW0177), dose 2 via an unspecified route of administration, administered in Arm Left on 14Jun2021 17:00 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included ongoing high blood pressure; ongoing high cholesterol and covid-19 virus from Apr2020 to May2020. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an intramuscular administration on 24May2021 in Arm Left (Batch/Lot number : EW0168 ) as 1ST DOSE, SINGLE for covid-19 immunisation. Patient reported the last vaccine she received was in the fall of 2020 and it was a flu vaccine and she's never had a problem with the flu vaccine. It was reported that patient her second dose yesterday, 14Jun2021. This morning she had extreme chills and a fever. Her temperature was 101.4 degrees Fahrenheit. She has been checking her temperature constantly. She took Tylenol 500mg and two hours later she took a second one because her fever was coming back, her fever was increasing. Now her fever was increasing again and she was asking if she could still take the Tylenol. She read the instructions and it says not to take more than 4000mg in one day. She had no other symptoms with the second COVID 19 vaccine and she had no reaction with the first COVID 19 vaccine. She hoped the second COVID 19 vaccine would have been the same as the first with no reaction. She's reading in her vaccine paperwork that she was not having a severe reaction but she was still concerned with her fever. Patient reported she got her COVID 19 vaccine through her job. She worked for the Department of Health. She thought reporting would benefit other people so she knew exactly what kinds of symptoms people could get. Her paperwork had instructions that said to go to the hospital with more severe symptoms which she doesn't have. She's concerned with the fever going up and down and the chills. She had the chills to the point that she was shaking. She got the instructions from the place where she got the COVID 19 vaccine. The paperwork said for certain severe reactions to call the ambulance but for less severe symptoms it's ok to take Tylenol which she did this morning. She was afraid to take two Tylenol because she thought it might be to strong. But after a couple hours when her fever was going back up she thought she should take another Tylenol. Tylenol 500mg tablets, Lot number : GS13604, Expiry Jul2023. It was reported that her symptoms started around 6:00AM this morning, 15Jun2021. She had woken up earlier and was fine then all of a sudden around 6:00AM her symptoms started. Patient would like to add that in Apr2020 she had the COVID 19 virus. She didn't even know she had the virus. She did have some symptoms but her symptoms weren't listed as symptoms yet because the virus was new. She had gone to her gynaecologist in May2020 and had a COVID 19 virus antibody test done and the doctor called her a couple days after the test and told her it was positive for the COVID 19 virus antibodies. Patient assumed according to the dates and times when she contracted the COVID 19 virus because not long after her husband had gone to the bank and someone at the bank had been sick. Her husband started coughing. She had chills and chills were not listed as a symptom of the COVID 19 virus at that time. She also lost her taste and she doesn't think that was a symptom at the time either. She had the COVID 19 virus in the beginning of Apr2020 and was tested for antibodies in May2020. She had the chills but no fever. She knows that fever was listed as a symptom of the COVID 19 virus. Her husband was coughing but she never had a cough. She just had the chills and the loss of taste. She had no idea she even had the COVID 19 virus because it wasn't that bad, she even went to work, it wasnot severe. She didnot need to say home. At that time she thought maybe her symptoms were due to the stress and craziness of what was happening with the COVID 19 virus. Honestly she wasn't to comfortable getting the COVID 19 vaccine. She decided to get the vaccine because of certain factors. She and her husband may have to travel out of the country because of terminally ill parents. She may not have been able to travel if she hadn't gotten the vaccine. But honestly she didn't get the COVID 19 vaccine in the beginning because she wasn't 100 percent comfortable doing it. Patient did not administered with any vaccine on same date with the Pfizer vaccine. Patient did not visited to emergency room and physician room. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of events with Tylenol. The outcome of all event was not recovered. No follow-up attempts are possible. No further information is expected.
50 2021-06-19 numbness Pt said her arms and legs went numb. BP was measured at 204/124 which reduced to 127/87 five minutes... Read more
Pt said her arms and legs went numb. BP was measured at 204/124 which reduced to 127/87 five minutes later. HR reading every few minutes: 102, 120, 116, 112. Pt also reported nausea and vomitting
50 2021-06-20 numbness swollen lymph nodes in neck, and general swelling in neck. this lasted for two weeks. At points duri... Read more
swollen lymph nodes in neck, and general swelling in neck. this lasted for two weeks. At points during that time my lower jaw was numb. Extreme headaches and stiff neck. Headaches would wake me in the middle of the night. Extreme exhaustion. Also I started having extreme digestive problems. Upper abdomen would spasm and go rigid. When this happened my heart would race and my blood pressure would go up. Had two weeks of zero appetite, and had trouble tolerating food for a month.
50 2021-06-21 hot flush, muscle spasms Strong cramps and hot flashes. Feel off balance
50 2021-06-21 numbness Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, System... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild, Systemic: Vomiting-Mild, Additional Details: Initial BP reading: 204/124 which reduced to 127/87 5 minutes later. HR readings every few minutes: 102, 120, 116, 112
50 2021-06-21 numbness Blurred vision and high blood pressure at the time of the vaccine.; Blurred vision and high blood pr... Read more
Blurred vision and high blood pressure at the time of the vaccine.; Blurred vision and high blood pressure at the time of the vaccine.; Stomach pain with Hives; Stomach pain with Hives; loss of the right ear and numbness on the right side with shortness of breath as if she were congested; loss of the right ear and numbness on the right side with shortness of breath as if she were congested; loss of the right ear and numbness on the right side with shortness of breath as if she were congested; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 12:00 (Batch/Lot number was not reported) age at vaccination of 50-years-old, as single dose, for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing (Oxycodon). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; pioglitazone hydrochloride (ACTOS) taken for an unspecified indication, start and stop date were not reported; glipizide (GLIPIZIDE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021 the patient experienced blurred vision and high blood pressure, stomach pain with hives, loss of the right ear and numbness on the right side with shortness of breath as if she was congested. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care; the patient was hospitalized for 3 days and the events were also considered serious as disability. The patient was treated with cortisone to restore hearing. The patient underwent lab tests and procedures which included sars-cov-2 test unknown results on 28May2021, sars-cov-2 test negative on 26May2021 (Nasal Swab), sars-cov-2 test unknown results on 28May2021 (Nasal Swab). Outcome of the events was unknown. Information on the lot/batch number has been requested.
50 2021-06-22 involuntary muscle movements Patient states that she is experiencing neurological complications. Symptoms include jerking, loss ... Read more
Patient states that she is experiencing neurological complications. Symptoms include jerking, loss of motility, and difficulty breathing
50 2021-06-22 pain in extremity had covid Oct'20 - lost taste and smell, tight chest, cough, asthma, tired, stomach issues 1st shot ... Read more
had covid Oct'20 - lost taste and smell, tight chest, cough, asthma, tired, stomach issues 1st shot no issues except arm soreness 2nd shot - few days later got tightness in chest like asthma - went to DR to be checked and got medicine for 10 days. didn't work, so called back and they sent me to urgent care - they gave me a nebulizer... did that for several weeks. didn't work. Coughing is worse, tightness is still there and chest burning is now happening. Cough is incontrollable if i start talking ? I loose all my air. not as bad if just walking around / physical. I am very tired all the time. smell burnt stuff a lot. have had tests done, all come back normal. this is effecting my daily life and I'd like to figure out what is going on, why, and how long, is it permanent, what kind of damage is there, is it treatable, etc... I am really upset and frustrated. It has been 6wks.
50 2021-06-23 cold sweat, feeling hot, pain in extremity After the shot I got the worse headache of my life, throat started swelling. I hot really hot, clamp... Read more
After the shot I got the worse headache of my life, throat started swelling. I hot really hot, clampy and almost passed out. treated with Benadryl. Throat opened a little, but head really hurt. completely exhausted, woke up throwing up several nights. dizziness nausea, lump in throat as if having an allergic reaction, felt like an allergic reaction to shellfish. Also was unable to swallow or eat anything. For days just started breaking out in sweat. I was forced to stay in bed for 6 days. The shot was in the right arm and every since the arm gets very painful. Painful down to the joint. and the injection site is still swelling and itching.
50 2021-06-23 numbness, weakness Numbness felt in 2 fingers of left hand; and left face, mouth, cheek, felt within 2 minutes if getti... Read more
Numbness felt in 2 fingers of left hand; and left face, mouth, cheek, felt within 2 minutes if getting the shots. Symptoms have been on and off for 2-3 days, and came back consistently after that. Numbness is now felt still in fingers, face, mouth abs also ear and eye. All left side only. Noticed difficulty to focus, loss of some strength in left arm. Light headache. Increased blood pressure.
50 2021-06-24 nerve pain, electric shock sensation, feeling of body temperature change, numbness, pain in extremity, tremor Day of vaccine, I felt tunnel vision as soon as she pushed the plunger, thereafter I got intermitten... Read more
Day of vaccine, I felt tunnel vision as soon as she pushed the plunger, thereafter I got intermittent hot and cold sweats, headache, terrible shakes, then she was trying to take my BP which was so low she could not get a reading, after multiple attempts she did get a very low reading, my pulse was very low as well and barely felt. She went into the back and said she was going to get a EpiPen. Ambulance came, nurse did not get the chance to inject me with the EpiPen. they put a fan on me and had a pallet laid out for me to lay on. The made sure I was hydrated. I was impressed with how quickly and thoroughly they cared for me. I was finally up and responding after a few minutes and doing well by the time the EMT's showed. I walked home and by the time I arrived I was exhausted and drained. I laid down and the next day I had aches and pains throughout my body, like shooting nerve pain. In my right arm I had pain so bad I could not hold the phone, extremely electric, like shocks, lasted for 10 minutes. The day after this I was fine, I do have numbness every once in a while in my left arm.
50 2021-06-24 night sweats, pain in extremity injection site soreness; night sweats; itchy, hive-like rash on both arms 48 hours after shot; very ... Read more
injection site soreness; night sweats; itchy, hive-like rash on both arms 48 hours after shot; very mild pain during urination for a couple weeks; moderate arm pain the day after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8734), via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 14:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included flax seed oil (MANUFACTURER UNKNWON) and multi vitamin (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced injection site soreness and moderate arm pain the day after injection at 00:00, night sweats from second night and continued for 7 days, itchy hive-like rash on both arms 48 hours after shot (lasted for 2-3 days), no medical attention needed and urination pain for a couple weeks, all on an unknown date in Apr2021. The clinical outcome of vaccination site pain, itchy rash, night sweats, pain in arm and urination pain was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
50 2021-06-24 pain in extremity her arm is sore all the way down her arm to her fingers and up to the shoulder and a little up the b... Read more
her arm is sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck; her arm is sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck; her arm is sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck; she feels like her 2nd dose was administered into the fatty part of her arm and did not reach her muscle; This is a spontaneous report from a contactable consumer (patient) via US COVAX Support program. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172), via an unspecified route of administration, administered in arm left on 16Jun2021 11:00 as 2nd dose, single dose for covid-19 immunisation. Medical history included, overweight, heart issues, breathing issues, thyroid issues, CPap, gallbladder removal. Concomitant medications included hydrochlorothiazide taken for an unspecified indication and potassium taken for an unspecified indication. No prior vaccinations were done within 4 weeks. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172 ), via an unspecified route of administration, administered in arm left on 26May2021 11:00 as 1st dose, single dose for covid-19 immunisation. On 16Jun2021, she felt like her 2nd dose was administered into the fatty part of her arm and did not reach her muscle. On 17Jun2021, her arm was sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck. She mentioned that she had no problems with her 1st dose, she was asking if she should get another dose or what she should do. The girl who did the injection, was a tech at the CVS pharmacy. Stated she did not even get it in her biceps; she squeezed her arm not even near there until it puffed out; and then set the bandaid on the back of her arm not where she gave the shot. She tried to rub it but that did not help. She did take Tylenol and that helped a little. It was persisting on 17Jun2021. No additional vaccines administered on same date of the Pfizer suspect. She did not want her kids to get COVID. She mentioned she also take a plethora of supplements. Therapeutic measures were taken as a result of her arm was sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck with Tylenol. The outcome of the event she felt like her 2nd dose was administered into the fatty part of her arm and did not reach her muscle was unknown and not recovered for other events.
50 2021-06-24 pain in extremity Severe runny nose; achey; she had severe acid reflux and she didn't have that normally; chills; real... Read more
Severe runny nose; achey; she had severe acid reflux and she didn't have that normally; chills; really bad sore arm; Constant joint pain and headache; Constant joint pain and headache; This is a spontaneous report from a contactable Nurse (Patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Left Arm on 06Jan2021 13:30 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, dose 2 via an unspecified route of administration, administered in Right Arm on 25Jan2021 13:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation but after this second dose no adverse events is reported. Medical history included Hypothyroid, allergies: sulfa, allergies: Latex (Known allergies: Latex sulfa). Age at vaccination: 50. Pregnant at the time of vaccination: No. Facility type vaccine: Hospital. If COVID prior vaccination: No. If COVID tested post vaccination: No. If other vaccine in four weeks: No. Other medications in two weeks: Armor thyroid estrodile VIT D ibuprofen Tylenol. Concomitant medication(s) (in two weeks) included ibuprofen taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; thyroid taken for an unspecified indication, start and stop date were not reported. On 07Jan2021 at 02:45 PM patient experienced, Severe runny nose, achey, and chills, really bad sore arm. The next day she had severe acid reflux and she didn't have that normally. Patient also experienced, Constant joint pain and headache on 07Jan2021. Patient did not receive any treatment for events. Facility information available. Ethnicity information is available. For all events, outcome was not recovered. Information on the Lot/Batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
50 2021-06-25 tingling She was given Pfizer vaccination and immediately developed facial swelling and throat tightness. Sh... Read more
She was given Pfizer vaccination and immediately developed facial swelling and throat tightness. She was treated with Benadryl and observed. She came to my office for an allergy consult. Discussed avoiding second dose of vaccine. She complained of paresthesia's and recommended neurology evaluation.
50 2021-06-26 pain in extremity Sore arm for 1 day
50 2021-06-26 tingling, numbness Within 15 minutes of receiving the vaccine, my left arm/hand was numb and tingling. Within 1 hour o... Read more
Within 15 minutes of receiving the vaccine, my left arm/hand was numb and tingling. Within 1 hour of receiving the vaccine, both of my legs/feet and right arm/hand also became numb and tingling, and I felt muscle weakness. On 06/17, I started taking Prednisone for 5 days, which helped reduce the numbness and tingling but did not eliminate it. After ending the Prednisone treatment, the numbness and tingling increased again. It has now been 17 days since the vaccine and I still feel numbness and tingling in both arms/hands and legs/feet. It has reduced in intensity but has not gone away.
50 2021-06-28 pain in extremity by the 9th day I developed excruciating headaches, shooting pain through the left temple to the le... Read more
by the 9th day I developed excruciating headaches, shooting pain through the left temple to the left eye, painful to open and close left eye, a bruise under the left eye and edema under the left eye, arthritic type pains and shooting pains through the body and arms, pains in hands and fingers; pains in the small vessels and big inner and bruises on the right elbow. Toughing veins on the arms and legs is painful. bursting pain behind ears, a mild feeling of angio-edema in my throat, pains lymphatic knots under arms,
50 2021-06-29 weakness Crying; Positive for COVID; Headache; aches; Coughing; Feels weak and powerless; Chest pain between ... Read more
Crying; Positive for COVID; Headache; aches; Coughing; Feels weak and powerless; Chest pain between boobs that was very heavy; Angry; Chills/shivering; cold; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), intramuscular, administered in Arm Left on 16Mar2021 (at the age of 50-years-old) as dose number unknown, 0.3ml single for covid-19 immunisation. The medical history and concomitant medications were not reported. On 17Mar2021 the patient experienced headache, aches, coughing, feels weak and powerless, chest pain between boobs that was very heavy, angry, chills/shivering, cold. On 22Mar2021 the patient experienced positive for covid. On an unknown date the patient experienced crying. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 22Mar2021. The outcome of the events positive for covid, aches, cold and crying was unknown, for the event chest pain between boobs that was very heavy the outcome was resolved on 19Mar2021, for rest of the events the outcome was resolving. Description of complaint: Patient received Pfizer COVID vaccine on 16Mar2021 and tested positive for COVID on 22Mar2021. Processing complaint for LOE as per verbatim not clear after first shot or second Covid positive. No correspondence as reporter information not provided. Reporter, his wife, son and daughter all received the Pfizer COVID vaccine. He did not get tested for COVID, but his wife, son and daughter did and they all tested positive after receiving the vaccine. He assumes he has COVID as well since he has the same symptoms and lives in the same household. Conclusion: The complaint for an adverse event requested by Safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6206 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations, and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to the reported finished goods lot EN6206, fill lot EN5339, and the bulk formulated drug product lot EN5327. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed. Follow-up attempts completed. No further information expected.
50 2021-06-29 burning sensation, pain in extremity I didn't feel anything all day after my vaccine except my arm was a little bit sore. That night arou... Read more
I didn't feel anything all day after my vaccine except my arm was a little bit sore. That night around 9:00/10:00 PM I started having a rash and itchiness. It lasted for a couple days so I called my work and they sent me to urgent care and at the doctor they said it wasn't and it could be a rash from the vaccine. It did go away for a couple of weeks and I was fine but I started one medication and it ended up starting all again in May. I only took one pill in the morning and I started having the itchiness in my eye in the evening. It was itching so bad so I took my medication again. They also gave me some eye drops for my eyes because it was really bad and it didn't help me. I made appointment with my regular doctor and explained everything and he gave me another medication to take for four days and it would stop everything but it didn't help me either. I made an appt with my eye doctor to see what was going on because my eye was red and itchy and he told me it was allergies and he prescribed me some more eye drops. It does seem to help a little bit but the itching now is getting worse and it's like a rash. I called my regular doctor again and he sent me to get lab work to see if it was an allergy and I called yesterday and they said the labs were normal. He said he's going to send me to the dermatologist to check my skin so I'm waiting right now to see them. My head burns, around my neck and it itches and when I put alcohol on it it feels a little bit better. It feels like a pimple on my head. I am a care taker and they have a dog and a cat and I thought maybe I was allergic to that but I had been there for a few months with no problem and it only started after vaccine. This is still ongoing.
50 2021-06-29 numbness Numbness throughout left side of the body (injection was left arm),; difficulty swallowing; shortnes... Read more
Numbness throughout left side of the body (injection was left arm),; difficulty swallowing; shortness of breath,; dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 22Mar2021 at 10.30am as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 22Mar2021 at 10.30 am, the patient experienced numbness through left side of the body (injection was left arm), difficulty swallowing, shortness of breath and dizzy. No therapeutic measures were taken for the treatment of reported events. The events had not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events numbness through left side of the body (injection was left arm), difficulty swallowing, shortness of breath and dizzy was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
50 2021-06-29 migraine felt like spine was being crushed; severe lymphatic swelling in axilla, chest, back and left breast;... Read more
felt like spine was being crushed; severe lymphatic swelling in axilla, chest, back and left breast; fever > 102F with tylenol for over 48 h then remained > 100F for 3 days; debilitating extreme pain in every cell for 24 hours; migraine; sores in mouth; lethargy; lt arm swollen hot, red itchy for a week and a half; lt arm swollen hot, red itchy for a week and a half; This is a spontaneous report received from a contactable other health care professional. A 50-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6206) via intramuscularly in left arm on 19May2021 07:45 (age at vaccination 50year old) as single dose for covid-19 immunization. Medical history included hypertension, Hypothyroid, High blood sugar TB test from an un-known date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included hctz (HCTZ), metformin (METFORMIN); levothyroxine sodium (SYNTHROID); ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); olmesartan medoxomil (BENICAR). For all these concomitant products start and stop date and indication were not reported. The patient previously received first dose of BNT162B2 (Lot: EN6199) on 28Apr2021 09:00 AM (age at vaccination 50year old), via intramuscularly, in left arm for covid-19 immunisation. Historical vaccination include flu shot, and patient had history of receiving seldane for unspecified indication. Patient doent had covid prior vaccination and had not tested positive to covid post vaccination. The patient experienced felt like spine was being crushed, severe lymphatic swelling in axilla, chest, back and left breast, fever > 102f with tylenol for over 48 h then remained > 100f for 3 days, debilitating extreme pain in every cell for 24 hours, migraine, sores in mouth, lethargy, lt arm swollen hot, red itchy for a week and a half on 19May2021 19:15. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature resulted as 102 on 19May2021. The clinical outcome of the events recovered with sequelae on unspecified date in 2021. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-06-29 nerve pain The day after my second vaccine shot (it was a Saturday) I experienced a sore neck where it was beco... Read more
The day after my second vaccine shot (it was a Saturday) I experienced a sore neck where it was becoming difficult for me to turn my head to either side. By the next day (Sunday) I had SEVERE Occipital Neuralgia: extreme pain at the slightest movement of my neck as well as pain just laying still and not moving - the neck pain was severe and it was radiating in a lightning fashion up the back of my skull. The next pain was specific to the top of the neck at the base of the skull. It was not a pulled muscle radiating down into my shoulders. It was right at the base of the skull. By the 3rd day (Monday) I was still in pain and it hurt to even touch my scalp it was so sensitive. At the base of my hairline, the skin had a blotchy light red appearance throughout my hair. While the intense pain only lasted the 3 days I am still experiencing soreness in my neck even to now 6/30/2021 and I have difficulty turning my head to either side. It is not getting better at all. Sometimes I even feel the nerves coming up to the base of my jaw, and, possibly that my neck lymph nodes are sore.
50 2021-06-29 pain in extremity, burning sensation Arm pain and headache (I had them also with the first dose, but they did not seem outstanding becaus... Read more
Arm pain and headache (I had them also with the first dose, but they did not seem outstanding because most people report them) I had a dermal reaction (on the skin) at first it was a welt like a mosquito bite, but During the night I had a very strong rash of hives on my back, on the left side. The hives were very itchy and burning. I took an antihistamine and it improved a lot.
50 2021-06-29 pain in extremity, numbness Arm, pinky and thumb went numb, red, swollen, pain. Trouble breathing
50 2021-06-29 pain in extremity After vaccination a rash appeared on my left forearm (itchy, raised red patchthat felt hot to the to... Read more
After vaccination a rash appeared on my left forearm (itchy, raised red patchthat felt hot to the touch); Sweating; Dizzy; Itchy all over; Sore arm; This is a spontaneous report from a contactable consumer, patient. A 50-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8767) via unspecified route of administration in the right arm on 21 Mar2021 at 10:15 AM (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication includes Ibuprofen (UNKNOWN MANUFACTURER) on unknown date for unknown indications. The patient was allergic to sulfadrugs. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via unspecified route of administration in the left arm on 28Feb2021 at 11:15 AM (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 12:45 (approximately 2-3 hours after vaccination), the patient experienced a rash appeared on her left forearm (itchy, raised red patch that felt hot to the touch). Shortly thereafter another appeared on her left forearm. Later, the patient woke up in the middle of the night sweating a lot, dizzy when she changed her positions and itchy all over. The patient was able to go back to sleep and she was fine when she woke up. Just a sore arm. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of event rash and included treatment with antihistamine. The clinical outcome for the events rash, sweaty, dizzy, sore arm and itchy were resolved on an unknown date. No follow-up attempts are possible. No further information is expected.
50 2021-06-29 pain in extremity Sore arm for 24 hours.; Became achey the next evening and subsided a few hours later. No other infor... Read more
Sore arm for 24 hours.; Became achey the next evening and subsided a few hours later. No other information provided.; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 06Feb2021(at the age of 50-year-old) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks and other medications in two weeks. Patient had no covid prior vaccination and not tested covid post vaccination. On an unspecified date, the patient experienced sore arm for 24 hours, became achey the next evening and subsided a few hours later. No other information provided. Patient did not receive treatment for events. The outcome of the events was recovered on an unspecified date in 2021. Information on lot/batch number has been requested. Follow-up attempts completed. No further information expected.
50 2021-06-29 tingling, numbness Shortness of breath; Severe numbness and tingling in all limbs, both arms and legs, hands and feet.;... Read more
Shortness of breath; Severe numbness and tingling in all limbs, both arms and legs, hands and feet.; Severe numbness and tingling in all limbs, both arms and legs, hands and feet.; Very sore armpit on same side as injection site; This is a spontaneous report from a non-contactable consumer or other non hcp. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 12:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Raynaud's phenomenon from an unknown date and unknown if ongoing, menopause from an unknown date and unknown if ongoing and Historical Vaccine BNT162B2 (Dose number: 1) for COVID-19 immunization in on an unspecified date in Apr2021. The patient's concomitant medications were not reported. The patient experienced shortness of breath, severe numbness and tingling in all limbs, both arms and legs, hands and feet, very sore armpit on same side as injection site on an unspecified date. There were no other vaccines in four weeks. There was no treatment received. Patient did not have Covid prior vaccination. Patient was not Covid tested post vaccination. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. And there were not any other medications the patient received within 2 weeks of vaccination. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-06-29 tingling Tight & heavy chest, tingling left arm/hand for 24 hours occurred on the 2nd day after the 2nd COVID... Read more
Tight & heavy chest, tingling left arm/hand for 24 hours occurred on the 2nd day after the 2nd COVID vaccine. Sleeping with head elevated seemed to help. Symptoms resolved by 1/11/21 in the mid-morning.
50 2021-06-30 feeling hot May 1 - Room would spin when I rolled over. Vertigo, sense of dizziness throughout the day, felt sl... Read more
May 1 - Room would spin when I rolled over. Vertigo, sense of dizziness throughout the day, felt slightly nauseated due to it. May 26 - felt like I was going to pass out when I was walking into a store - legs heavy, vision closing in, had to sit down. June 3 - slightly nauseated - still sort of a sense of things being off spacially, dizzy June 12 - standing with a group at an celebration of life, suddenly felt hot, vision got a bit blurry, felt like I was going to pass out. Went into another room and sat and drank water. June 19 - when I close my eyes while praying for someone I feel dizzy have to open them. June 21 - another much worse bout of vertigo, couldn't walk, everything tilting, Lasted a while. June 24 - Felt like I was going to pass out in the morning, bp up to 151/103 Basically VERTIGO (which I have never had), DIZZINESS and a sense of PASSING OUT. All bloodwork fine, Dr. saying next step is ENT if this doesn't stop.
50 2021-06-30 pain in extremity sore arm; extreme soreness of muscles around the shoulders and neck area; This is a spontaneous repo... Read more
sore arm; extreme soreness of muscles around the shoulders and neck area; This is a spontaneous report from a contactable other HCP (patient herself). A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EC3302), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 08:30 (at the age of 50-years-old) as dose 1, single for covid-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive the any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Jan2021, the patient experienced sore arm extreme soreness of muscles around the shoulders and neck area. The patient did not receive treatment for the event. On 08Feb2021, the patient received her 2 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, administered in Left as dose 2, single for covid-19 immunisation. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.
50 2021-06-30 pain in extremity Arm soreness, on day 4 the arm pain was quite severe and persisted at rest; This is a spontaneous re... Read more
Arm soreness, on day 4 the arm pain was quite severe and persisted at rest; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration on left arm on 17Mar2021 at 14:00 as a single dose (at the age of 50-year-old) for COVID-19 immunisation. The patient was not allergic to any medications, food, or other products. The patient medical history was reported as hyperthyroidism. Concomitant medications included synthroid (MANUFACTURER UNKNOWN), valacyclvir (MANUFACTURER UNKNOWN), levonorgestrel (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on left arm on 24Feb2021 at 14:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 21Mar2021 at 17:00 (first few days after vaccine), the patient experienced minor arm soreness however on day 4 the arm pain was quite severe and persisted even when patients arm was at rest. On day 5 and not as severe but still hurts every time when she moves her arm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as result of events and included treatment with meloxicam. The clinical outcome of arm pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-01 breast pain, pain in extremity pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; ... Read more
pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; This is a spontaneous report from a contactable nurse (patient). A 50-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9262), via an unspecified route of administration, administered in left arm on 28Jan2021 (age at the vaccination 50-year-old) as second dose single for covid-19 immunisation. Medical history included breast cancer survivor, extreme burning and ongoing swelling (I am a 16-year breast cancer survivor and had extreme burning and swelling at my tumor field). Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (Lot number: EH9899) via an unspecified route of administration, administered in left arm on 07Jan2021 12:00 PM for Covid-19 immunisation. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. if other vaccine in four weeks reported as no. On 28Jan2021 04:45 PM it was reported that patient 16-year breast cancer survivor and had extreme burning and swelling at my tumor field. Even today patient have pain and swelling in my left breast and left arm. Patient did not receive treatment for the adverse events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available currently available the reported events can be considered as an aggravation of the underlying medical condition, nevertheless the contributory role of the vaccine BNT162B2 to this aggravation cannot be excluded because of strong temporal relationship. The case will be reassessed if there is any new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
50 2021-07-01 cold sweat, cold extremities Client stated she was feeling pressure in her right ear and lightheaded. Lead RN made contact with t... Read more
Client stated she was feeling pressure in her right ear and lightheaded. Lead RN made contact with the client at approximately 1305 to assess the client. Client stated that approximately 15 minutes after her vaccination she felt dizzy and had pressure in her right ear and in her chest. She denied any shortness of breath, difficulty breathing, chest pain or swelling of her lips, throat or mouth. Client reported having a history of deafness, Lupus, high blood pressure and an allergy to penicillin which gives her hives. She denied any other allergies to medication/food/environment. Client stated she takes Levothyroxine, Hydroxychloroquine, and atenolol daily otherwise denies any other medication use. A first set of vitals were taken at 1310, blood pressure (BP): 140/80, Heart rate (HR) 72, Respiratory Rate (RR) 14, client's skin was pale and clammy. Client stated her last oral intake was at 0830 and she had a small cup of tea and toast with butter. Client was given a water bottle which she drank and a sugarfree lollipop as she declined the other snacks offered due to avoiding sugars and gluten in her diet. Client stated her BP was normal level for her and that she had been having pressure behind her eyes and in the middle of forehead for a few days due to having elevated BP but denied having the ear pressure prior to vaccination. Client was advised by Lead RN to stay in the zero gravity chair and in observation for an additional 30 minutes for monitoring. At 1320 a second set of vitals were taken: BP 138/78, HR 72, RR 14, skins: normal for ethnicity, slightly clammy with cool fingertips. Client stated the pressure in her ear and chest were persisting but the dizziness/lightheadndess resolved when she laid down in the zero gravity chair. Client stayed in observation an additional 20 minutes and at 1340 stated she was feeling much better and her symptoms of dizzinesss, pressure in ears and pressure in chest had resolved. Lead RN advised client to follow up with PCP regarding ear and chest pressure and gave client ED precautions. Client verbalized understanding and left the observation site on her own accord with a steady gait.
50 2021-07-01 feeling cold Shortness of breath; there was a time where she felt like her blood sugar had dropped, almost like s... Read more
Shortness of breath; there was a time where she felt like her blood sugar had dropped, almost like she was having a hypoglycemic meltdown; became really sweaty and had to lay down; got really, really cold; Fatigue; pretty sick; This is a spontaneous report from a contactable consumer (Patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9269) via an intramuscular route of administration and administered in right upper arm on 05Feb2021 at around 14:30 (at the age of 50-year-old) as a single dose for COVID-19 immunization at public high school. The patient medical history included ongoing asthma, (diagnosed at 12 years old). Earlier in this week (as per report on Tuesday), she did have an endoscopy and had to go under, results not provided, this was prior to receiving vaccine. Concomitant medication included new stomach medication (Pantoprazole) on an unspecified date in 2021 (she just started it). She does not know if that caused an interaction and they told her it was fine, but who knows. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and additional vaccines administered on the same day of vaccine. On 06Feb2021, the patient was pretty sick over the weekend. She did not have a fever, but she experienced shortness of breath. There also was a time where she felt like her blood sugar had dropped. She became really sweaty and had to lay down. She also got really, really cold, almost like she was having a hypoglycemic meltdown. She did not know if that was something to be expected. Her and husband were a little nervous about her experience. She was feeling fatigued. These symptoms began Saturday morning (as per report) and have improved. She is feeling much better now. The events did not result in emergency room or physician office. Patient wants to know if what she was experiencing was normal and didn't think it was bad enough. She just figured it was a side effect and she didn't think to get checked out further and made a comment that she hasn't talked to her doctor about this. The outcome of the events was recovering. Follow-up attempts completed. No further information expected.
50 2021-07-01 numbness, pain in extremity, tingling Went to had vaccine administered. Swelling in my hands 25 minutes after shot was administered. H... Read more
Went to had vaccine administered. Swelling in my hands 25 minutes after shot was administered. Had already arrived home, called and was transferred to the pharmacy and spoke to pharmacist. Pharmacist asked a series of questions, stated my reaction was not life threatening and recommended Claritin 10mg & Benadryl 50ml and to follow up with my doctor or go to the emergency room if I can't breath. Experienced more swelling in hand, wrists, feet, face tingling, right ear numbness, lips itching/swelling, extremely dry eyes, red eyes, swollen veins in my right eye, blurred vision in right eye, severe headaches, pain in both forearms, sporadic chest discomfort, fatigue, brain fog. Left a message at my doctors office stating my allergic reaction, received a call from nurse practitioner with same over the counter medicine pharmacist suggested plus Pepcid AC 20mg & warm compress. We to see the doctor the following Saturday symptoms hadn't subsided. All my blood work came back normal. Doctor said he hadn't see this before not sure what to do. Possibly steroids but felt my body would adjust. Also went to ER, had chest X-Ray and labs. All came back normal. Called my allergy doctor, also said they didn't know what to do, referred me back to my primary doctor or go to the ER. Went to the ER didn't know what to do and recommended I ask my primary doctor to send me to a cardiologist. I still have same symptoms and same initial over the counter medications. No course of treatment from anyone THEREFORE I told my doctor to refer me to Immunology & Allergy, Cardiologist, and Ophthalmologist. No sense of urgency and I'm awaiting appointments over a month out.
50 2021-07-01 pain in extremity Sharp pain when got the injection which continued for 3 days; This is a spontaneous report from a co... Read more
Sharp pain when got the injection which continued for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN via an unspecified route of administration in left arm on 21Mar2021 at 10:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 21Mar2021, the patient experienced sharp pain when got the injection which continued for 3 days (First day after injection couldn't raise her left arm by the end of the day). The events had not resulted in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for events. The clinical outcome of event sharp pain when got the injection which continued for 3 days was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-07-01 tingling, numbness This is a spontaneous report from a contactable consumer, the patient. A 50 years-old non-pregnant f... Read more
This is a spontaneous report from a contactable consumer, the patient. A 50 years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 21Mar2021, (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was allergic to shrimps. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications (unspecified) within two weeks of vaccination. On 21Mar2021 at 09:00, the patient experienced tingling in left arm, left side of face and head and partial numbness of left side of face, mild rash at injection site and nausea. These events lasted for the day of vaccination and the next day. No therapeutic measures were taken for adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events tingling of left arm, left side of face and head, partial numbness of left side of face, mild rash at injection site and nausea was resolved on 22Mar2021. No follow-up attempts are needed. No further information is expected.
50 2021-07-05 pain in extremity, unresponsive to stimuli Pt. went to pharmacy on 6/22/21 to receive the second dose of Pfizer-BioNTech vaccine, lot number E... Read more
Pt. went to pharmacy on 6/22/21 to receive the second dose of Pfizer-BioNTech vaccine, lot number EW0177. The day after the vaccine was administered, her lower arm was swollen, red and her elbow felt hot to the touch. It was too painful to fully extend her arm. There was a white streak across the reddish purple elbow area where it appeared as though there was an infection growing. She went to her normal doctors office, she saw his nurse practitioner who took an x-ray and gave her two intravenous injections of antibiotic (unknown type). One in each buttock and prescribed an oral antibiotic: Cephalexin 500 mg., and Ibuprofen 800 mg. From that day forward she was unable to move the arm at all and the medication did not bring the swelling or the infection down. She was very tired and her arm did not lessen in pain as the days passed. On June 29, 2021 she was in her bedroom and her older daughter was in her room and believed her mother was resting. At approximately 7:20 p.m., pts. husband returned from work and came into the master bedroom turning on the television. As he did so he made joke expecting pt. to laugh or comment, when she made no response he looked over at her and saw that she was laying on the love seat at an awkward angle. He moved to her side and saw her eyes were open but unseeing and saw that her dental prosthetic was partially pushed out of place. He removed and called EMS immediately, not detecting any obvious signs of life. Her daughter came into the room and immediately started CPR. Paramedics arrived in under 2 minutes and moved pt. to the living room where they could intubate a breathing pathway and carried on with attempts to revive her heart muscle for approximately 25 minutes before Paramedic called time of death at 8:02 p.m. Paramedics departed and the Police arrived staying until the Mortuary attendants came to the home at about midnight to accept pt. body for transport to its facility. The Family is seeking an autopsy and the coroner is claiming one is not necessary. The family believes it is absolutely necessary to ascertain whether or not the second dose caused her death as it seems is likely and whether she should have been advised of her heighten risk level. Regardless of COVID 19 Emergency measures, an autopsy is necessary and the family is determined to ensure that it is conducted. Pt. has had a history of the following: Adult onset Asthma, allergic reactions in skin rashes that were significant. Hypothrodism (Graves Disease) which proved to be difficult to find the right meds to bring it under control; prone to incidents of Atrial fibrillation which have escalated as she has aged; she has been treated for emergency visits for Tachycardia; she frequently has developed respiratory issues as a result of the asthma which often landed her in the emergency and days in the hospital on oxygen. She often experienced shortness of breath and chest pain and last year underwent emergency appendicitis. Her last episode of atrial fibrillation which landed in the hospital was 12/29/16. She has been on anticoagulants for many years. Since COVID 19 she may not have been able to afford her Eliquis prescription however which she did not disclose to any of her family members that she was struggling in this wasy. She is likely not to have been taking her Hypothyrodism (Graves) medication either since these medications have not been recovered since her death.
50 2021-07-06 feeling hot, pain in extremity Syncope and Fainting; Dizziness; blood pressure goes up; sick; Bradycardia; affecting her memory, sh... Read more
Syncope and Fainting; Dizziness; blood pressure goes up; sick; Bradycardia; affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking;; affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking;; affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking;; made a rash, the skin has a different texture where they injected the shot; Sore Arm; feels a heat rush like she is about to pass out; rash; feel the bump there; like how when a person gets burned and the skin feels different, lots of little bumps; This is a spontaneous report from a contactable reporter (LPN). This 50-year-old consumer reported for herself that: A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot number:EH9899) via an unspecified route of administration, administered in Arm right on 23-DEC-2020(at the age of 50-year-old) and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL1284) via an unspecified route of administration, administered in Arm Left on 13Jan2021 at 09:00 as SINGLE for covid-19 immunisation. Medical history included blood pressure measurement. There were no concomitant medications. On 23Dec2020, the patient experienced dizziness, syncope and fainting, Bradycardia, blood pressure goes up, feels a heat rush like she was about to pass out, affecting her memory, she cannot concentrate or focus, something is happening neurological with her thinking, made a rash, the skin has a different texture where they injected the shot, can see and feel the bump there; like how when a person gets burned and the skin feels different, lots of little bumps, Sore Arm. but she took Aleve and it was gone in 2-3 days. On 24Feb2021 got very sick, dizzy, and lightheaded, and when she got there, her blood pressure was extremely high. The patient received treatment with Aleve, Hydralazine 10 mg, Amlodipine 25mg.The patient had Recovered from sore arm on 26Dec2020, not recovered from dizziness, syncope and fainting, feels a heat rush like she was about to pass out, affecting her memory, she cannot concentrate or focus, something is happening neurological with her thinking, made a rash, the skin has a different texture where they injected the shot, can see and feel the bump there; like how when a person gets burned and the skin feels different, lots of little bumps and Unknown for Bradycardia, blood pressure goes up.; Sender's Comments: Based on the strong temporal relation, the association between the events syncope, dizziness, blood pressure increased and illness and the vaccination cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-07-06 migraine Nausea, migraine headache, dizziness, fever, chills, lethargy
50 2021-07-06 migraine she was admitted to hospital with a level 10 headache; The team were considering a diagnosis between... Read more
she was admitted to hospital with a level 10 headache; The team were considering a diagnosis between a migraine and a neurologic issue; The team were considering a diagnosis between a migraine and a neurologic issue; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's husband). Caller was calling on behalf of wife. A female patient of 50-year-old received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0170), via an unspecified route of administration, administered in arm left on 03May2021 (at the age of 50-years-old) as dose 2, single for COVID-19 immunization at Pharmacy. Medical history included ongoing rheumatoid arthritis and patient had this condition for more than 10 years. She had an immune deficiency and was taking a biological to reduce the effects of RA. She was in full remission prior to the vaccination and the doctor recommended coming off biologicals. Concomitant medications included etanercept (ENBREL) taken for rheumatoid arthritis from 2021 and ongoing. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Expiry Date: 28Jul2021/Lot Number: not reported), via an unspecified route of administration, administered in arm left on 12APR2021 as dose 1, single for COVID-19 immunization and experienced mild to moderate headache, rheumatoid arthritis flares up, mild-chills, arm ache, bedridden on an unspecified date in Apr2021. These symptoms all lasted almost up until his wife got her second dose of the vaccine. After the first dose of vaccine, doctor recommended going back to biologics because of a RA flare up. Had been off this medication since Jan or Feb2021, was placed back on it after the first dose of the vaccine. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks of the suspect vaccine. No AE following prior vaccinations. No Family Medical History Provided Relevant to AE. After the second vaccination, on 03May202, the same evening after she received it, the patient developed a level 10 headache. The headache never stopped, and the caller took his wife to the Emergency Room. She was admitted to hospital with a level 10 headache, she saw neurologists, pain management, a whole team, trying to figure it out." The team were considering a diagnosis between a migraine and a neurologic issue on May2021. Patient was hospitalised for 5 days and 4 nights from 22May2021 to 27May2021 receiving care and she was discharged with her case unsolved, with the statement from the doctor's that they could not do anything else for her. All their discharge notes and statements indicate they can't do anything for her. The adverse events level 10 headache resulted in emergency room and physician office visit. His wife has been out of hospital for two weeks now. She was bedridden right now. Patient reported the migraine pain as, "a metal spike inside her skull." She has been this way for 2.5- 3 weeks. It has been relentless and was in a fully debilitated mode. The patient underwent lab tests and procedures which included blood test: unknown, computerised tomogram: unspecified, magnetic resonance imaging: unspecified on May2021. She has had head, neck, and spine CT/MRI scans. Headache was down to a level 7. Treatment included that she was on heavy narcotics and migraines medications. Doctor's determined that the common link was the Covid Vaccine and could be the Pfizer covid vaccine. The caller was asking for a doctor or team they can meet with to discuss her situation and asked did Pfizer have something to treat the person with, or something to reverse the vaccine. Outcome of event was recovered and unknown for Migraine and nervous disorder.
50 2021-07-06 tingling 6/23 pt started feeling tingling in her right arm. 6/24 at 3 AM pts heart started racing, nauseated,... Read more
6/23 pt started feeling tingling in her right arm. 6/24 at 3 AM pts heart started racing, nauseated, body aches, couldn't stand up. 6/25 pts symptoms were worsening and her family urged her to seek medical evaluation at the ED. At the ED on 6/25 at 10 AM pts BP was 269/169 and they gave her IV pain meds and anti nausea medication and fluids. The ED discharged her at 4pm on 6/25. Pt couldn't keep food down at home, Pts BP readings ranged from very high to very low. Pt went back to the ED 6/28/21. Pt states ED didn't do anything at this visit. Then pt went back to ED 7/4/21. ED did EKG, ultrasound of legs and pt was discharged the same day.
50 2021-07-07 weakness, tremor not taking 2nd dose; lethargic/crash culd not move; anaphylactic shock; difficulty breathing/shallow... Read more
not taking 2nd dose; lethargic/crash culd not move; anaphylactic shock; difficulty breathing/shallow; difficulty breathing/shallow; tongue swollen and felt like bits of glass crystals were pushing out of my tongue for hours, like fiberglass; Severe weakness; shaking; chills; lethargic/crashed could not move; I got sicker and sicker and sicker; unknown collection of autism spectrum neurodevelopmental disorders; dysautonomia & all body systems dys- or mal-regulated and asynchronous; cognitive changes; Increasingly ill; feeling of dis-ease, something very wrong; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 21Apr2021 10:00 (at the age of 50-year-old) at dose 1, single for covid-19 immunisation. Medical history included Autism spectrum conditions (Autism spectrum conditions, but I don't know which genetic disorders or how many). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Yes too many to list here. Prior to vaccination, it was unknown whether the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date in on May2021 the patient experienced an-aphylactic shock, difficulty breathing/shallow, tongue swollen and felt like bits of glass crystals were pushing out of my tongue for hours, like fiberglass, severe weakness, shaking, chills, lethargic/crashed could not move and on 21Apr2021 10:00 unknown collection of autism spectrum neurodevelopmental disorders, increasingly ill, dysautonomia & all body systems dys or mal-regulated and asynchronous, cognitive changes, feeling of disease, something very wrong, i got sicker and sicker and sicker. Increasingly ill to 30 days when I was experiencing such toxicity I called and ambulance & went to ER. dysautnomia & all body systems dys or mal-regulated asynchronous. Cognitive changes, feeling of did-ease, something very wrong not a vaccine cycle of reaction and resolution: I got sicker and sicker and sicker. Acute stage/30 days after: difficulty breathing/shallow, tongue swallow and felt like bits of glass crystals were pushing out of my tongue for hours, like fiberglass; severe weakness, shaking, chills, lethargic/crashed could not move. Patient believe that patient experienced anaphylactic shock response 30 days after my first dose. Patient has an unknown collection of autism spectrum neurodevelopmental disorders and physiological developmental disorders; Autists have unusual and long protein sequences, every-thing is affected. stuck with some effects; not taking 2nd dose, please do better by all the people with genetic conditions and by non-males. Patient did not receive treatment for the adverse events. Adverse events led to the emergency room visit. Outcome of the event not taking 2nd dose was unknown and remaining all the events was resolved with sequel on an unspecified date in 2021. No follow-up attempts are needed. Information on batch/lot number cannot be obtained.
50 2021-07-07 weakness Admitted after missing dialysis, reporting weakness in early June 2021. Guillian-Barre syndrome ide... Read more
Admitted after missing dialysis, reporting weakness in early June 2021. Guillian-Barre syndrome identified during admission. Currently admitted and receiving IVIG and plasmapheresis. Pt also with CMV colitis and hypotensive
50 2021-07-07 burning sensation Within 3-4 hours of getting the vaccine I started feeling feverish. My temp was 99.8-99.9, my blood ... Read more
Within 3-4 hours of getting the vaccine I started feeling feverish. My temp was 99.8-99.9, my blood consistently. I then started experiencing this burning uncomfortable sensation in my chest area and pain in the middle of my back. this discomfort lasted for hours. I contacted the nurse and was told to go to the ER for observation.
50 2021-07-07 discomfort Directly after the vaccine, within less than an hour, I experienced a tightness in my throat, and sw... Read more
Directly after the vaccine, within less than an hour, I experienced a tightness in my throat, and swelling of my lymph area around my throat. I still had air, but was concerned for the noticeable tightness of throat which continued for hours. This was better the next day, but since then, I have not stopped ?spotting? in an irregular menstrual spotting and has not ceased. Yesterday however, 7/7/21, I was too tired to keep my eyes open in the afternoon, laid down for a power nap, and there was a noticeable irregular heartbeat twice, in which I was awoken from my nap twice due to what seemed to my heart not beating normally, my chest seemed heavy, and both times after waking from a nap and noticing, I noticed my left arm in the vein area slightly uncomfortable. I have also had to take ibuprofen for a headache yesterday and on one other occasion , and yesterday my lymph in my throat were swollen slightly again- and neither of these symptoms are normal for my own body . I did not get the 2nd dose yet , but due to tightness of throat, I don?t plan to either. I just feel like I should say something.
50 2021-07-07 pain in extremity After the vaccination i had body aches and was light headed but it went away the same day but a week... Read more
After the vaccination i had body aches and was light headed but it went away the same day but a week later my arm pain was really bad and it got worst and worst. I had chest pains and that's when i went to the doctor and they ran test on me EKG and blood work
50 2021-07-07 pain in extremity Pt called in only to report side effects that occurred 2 weeks ago. Reports 24hrs after 1st dose Pf... Read more
Pt called in only to report side effects that occurred 2 weeks ago. Reports 24hrs after 1st dose Pfizer bilateral arm soreness, itchiness, bilateral swelling of ears, ""felt like ears were aching."" Neck, shoulder and back stiffness. States she took tylenol and benadryl with no improvement. States has a history of allergic reactions to vaccines, but unsure which vaccines, ""never figured it out."" Has been 8 years since last allergic reaction. Pt spoke with outside PCP and will calll again to reschedule dose 2 appt. NO ER sxs at time of call.
50 2021-07-07 pain in extremity Fatigue, fever, nausea, diarrhea, dizziness, headache arm pain,
50 2021-07-07 tingling Extreme persistent full body joint paint - Still going to this day. (Three and a half months later a... Read more
Extreme persistent full body joint paint - Still going to this day. (Three and a half months later and counting). Tingling/burning scalp for a month after vaccine shots.
50 2021-07-08 flushing Site injection soreness followed by fever 1o1.5, chills, body aches. My skin hurts. Face flush, eyes... Read more
Site injection soreness followed by fever 1o1.5, chills, body aches. My skin hurts. Face flush, eyes hurt.
50 2021-07-08 pain in extremity Swollen arm; Body ache; headaches; Arm sore; This is a spontaneous report from a contactable consume... Read more
Swollen arm; Body ache; headaches; Arm sore; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8730) via unspecified route of administration in the left arm on 22Mar2021 at 10:00 (at the age of 50-years-old) as a single dose for Covid-19 immunisation. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had not been tested positive for COVID-19 since having the vaccine. It was reported that the patient was on medication for blood pressure and thyroid. On 22Mar2021, the patient experienced arm pain, it was reported that the pain was really sore at upper arm and underneath arm. After 3 days, on 25Mar202, the patient woke up with whole body aching, headache and swollen arm. It was reported that the patient was taking TYLENOL since getting the shot. The clinical outcome of the events arm pain, headache, body ache and swollen arm were unknown. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No follow-up attempts are needed. No further information is expected.
50 2021-07-08 pain in extremity Steady headache; arm only slightly sore around injection site; Sore arm; This is a spontaneous repor... Read more
Steady headache; arm only slightly sore around injection site; Sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8732) via an unspecified route of administration on left arm on 25Mar2021 at 09:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergy to compazine and codeine. The patient had received concomitant medications within two weeks of vaccination. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 10:00, the patient experienced sore arm and on 26Mar2021, the patient experienced steady headache that did not respond to ibuprofen but not debilitating, and arm only slightly sore around injection site. The patient was treated with ibuprofen (MANUFACTURER UNKNOWN) for steady headache. The patient did not receive any treatment for the events sore arm and arm only slightly sore around injection site. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events sore arm, steady headache that does not respond to ibuprofen but not debilitating and arm only slightly sore around injection site was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-08 tingling Tingle; This is a spontaneous report from a contactable consumer. A 50-years-old non-pregnant female... Read more
Tingle; This is a spontaneous report from a contactable consumer. A 50-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN5318) via an unspecified route of administration on left arm on 02Feb2021 at 03:00PM as single dose (Age at Vaccination: 50 years) for COVID-19 immunization. The patient medical history included drug allergy, food allergy and allergies to other products: insect bites: kissing bug and nickel. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no covid prior vaccination and had no covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. 02Feb2021 03:00 PM, the patient experienced within about a minute bottom lip of the patient started to tingle and lasted for about 15 minutes. The patient inquired is tingling an allergic reaction. No treatment was received. The outcome of the event was resolved. No follow-up attempts are needed. No further information is expected.
50 2021-07-09 tingling within 45 min developed allergic rxn symptoms - throat closing and facial swelling, paresthesia. Ov... Read more
within 45 min developed allergic rxn symptoms - throat closing and facial swelling, paresthesia. Over the following days after vaccine, pt developed muscle weakness, leg stiffness w./ trouble ambulating and chest pains. Using cane to walk at times. Has been on disability since vaccine.
50 2021-07-10 weakness, feeling hot Chills; Felt hot through the night; fever; weakness; felt tired; This is a spontaneous report from a... Read more
Chills; Felt hot through the night; fever; weakness; felt tired; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; UNKNOWN), via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included oral thrush. The patient had a history of allergy to oysters, Vicodin, penicillin and had seasonal allergies. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN) and DIFLUCAN for unknown indication received within two weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 27Mar2021 at 14:00, about 30 min after the vaccination, the patient felt tired. Within 1 hour at 14:30, the patient had a fever, weakness and had to lay down. This was only the first dose. On the same day at 16:00, the patient had chills which were continued and had felt hot through the night. It was reported that the patient had to take Tylenol. Adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events felt tired, fever, weakness, chills and felt hot through the night was unknown at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
50 2021-07-10 feeling hot, pain in extremity got very sick; lightheaded; her blood pressure was extremely high/Blood pressure goes up; Passed out... Read more
got very sick; lightheaded; her blood pressure was extremely high/Blood pressure goes up; Passed out and what she would call a loss of consciousness; Syncope; feels a heat rush like she is about to pass out; made a rash; skin has a different texture where they injected the shot; lots of little bumps; Bradycardia; Sore Arm; affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking; affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking; affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking; This is a spontaneous report received from a contactable Nurse. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; 50-year age at time of vaccination), via an unspecified route of administration on 13Jan2021 (Batch/Lot Number: EL1284) as second dose at unknown dose single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported patient had, Passed out and what she would call a loss of consciousness on 24Feb2021; Syncope in 2021; lots of little bumps in 2021; Bradycardia in 2021. she was hospitalized for them back in April, and she was still having side effects. She states one of them dizziness and she feels a heat rush like she is about to pass out (in 2021). She states her doctor told her to report the side effects. She states she does need to talk about it, because any time, even if she is sitting, she feels like she can pass out. She states she did pass out her very first time, the day she went to the hospital. and she has had 3 today. Syncope AE: She states if she was not somewhere where she can catch herself or where she can sit, she knows she will pass out and has to take deep breaths until she can get herself together. Fainting AE: She states her biggest problem is the fainting. She states it is not just when she was walking, it was a at any time, sitting or lying too. She states at some point in time she thought she had orthostatic hypotension but it can't be because she can be sitting and get dizzy like she was fixing to pass out. She states she actually did the very first time. She states she thought she was just nervous but it happened in less than 3 minutes after getting the first vaccine. She states her side effects come and go. Memory AE: She states it is almost to the point where it is affecting her memory because she didn't have memory problems before. She states it is affecting her memory (in 2021), she can't concentrate or focus, something was happening neurological with her thinking. Skin had a Different Texture at the Injection Site AE: She states it made a rash (in 2021), the skin has a different texture where they injected the shot (in 2021), and she can see and feel the bump there. She states she knows it is where the injection went in with the first one and she believes that is the one that made the mark. She states is actually turned red but it didn't swell. She states right there were it was injected, it has improved because it is no longer red, but she just has an area of different skin texture there, like how when a person gets burned and the skin feels different, it feels like a lot of little bumps (in2021). She states she had no other side effects. She states no drowsiness, no fatigue. She states she did have a sore arm, but she took Aleve and it was gone in 2-3 days. She states the episode of dizziness came back 2 days later and then it went away for a week and then came back and one at a time until she started getting 2-3 episodes back to back at a time. She states that is what concerned her and prompted her to go to the doctors office. She states she was on the phone and she said oh, she doesn't feel good and all she remembers was sitting up right and she had fell over to the side, she considers that a loss of consciousness, because she doesn't remember. She states that was on 24FEB2021, the day of her admission when she went the hospital. She states she went to see her doctor and she got an order for a direct admission to the hospital and the ER was so busy and she got very sick, dizzy, and lightheaded, and when she got there, her blood pressure was extremely high (Blood pressure goes up). Treatment: Aleve, Hydralazine, Amlodipine. She states the put a Heart Monitor on her. Heart Monitor: She states they put a heart monitor on her and the leads broke her out and she had to turn that back in early because she had an allergic reaction to the leads. She states she knows she was off of work for 13 days and she wants to say she had the heart monitor put on that Monday after she was discharged. The outcome of the events Passed out was recovered on 24-FEB-2021; Blood pressure high was recovered in 2021; Syncope, Feeling hot was not recovered; Rash, Vaccination site discomfort, Vaccination site mass was Recovering, Bradycardia was recovered in 2021. Rest of the events was unknown. Reporter causality: Syncope and Fainting - Related Covid Vaccine: Blood Pressure Goes Up - Related Covid Vaccine: feels a heat rush like she is about to pass out - Related Covid Vaccine: affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking; - Related Covid Vaccine: Sore Arm - Related Covid Vaccine: made a rash, the skin has a different texture where they injected the shot, can see and feel the bump there; like how when a person gets burned and the skin feels different, lots of little bumps - Related Covid Vaccine: got very sick, dizzy,and lightheaded, and when she got there, her blood pressure was extremely high Related.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of loss of consciousness,syncope,illness,dizziness,hypertension,feeling hot,rash,vaccinationsite discomfort,vaccination site mass,bradycardia,pain in extremity,Thinking abnormal,memory impairment,disturbance in attention cannot be excluded.But also consider relevant medical history and concomittant drugs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-07-10 feeling hot Extremely hot and light headed immediately after vaccine was administered. Few hours later started i... Read more
Extremely hot and light headed immediately after vaccine was administered. Few hours later started itching all over. Still itching 2 days later.; Extremely hot and light headed immediately after vaccine was administered. Few hours later started itching all over. Still itching 2 days later.; Extremely hot and light headed immediately after vaccine was administered. Few hours later started itching all over. Still itching 2 days later.; This is a spontaneous report from a non-contactable consumer (Patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 10Feb2021 (at the age of 50-year-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had known allergies. The patient did not receive any vaccines within four weeks prior to the vaccination. On 10Feb2021, on the same day of vaccination, the patient experienced extremely hot and light headed immediately after vaccine was administered. Few hours later started itching all over. Patient still itched 2 days later. The patient did not receive any treatment for the event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-07-11 flushing, tremor Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Mild
50 2021-07-11 numbness Within minutes, patient experienced left sided ring and pinkey finger numbness. About 2 days later,... Read more
Within minutes, patient experienced left sided ring and pinkey finger numbness. About 2 days later, patient experienced left facial numbness and arm numbness and experienced; this persisted for about 2 days. The numbing sensation has persisted on and off since that time point. Patient presented to the ER and followed up with her primary physician after about a week. She has neurologist referral.
50 2021-07-11 tingling tingling cool sensation in her lower legs from her knees down/tingling cool sensation in elbow and f... Read more
tingling cool sensation in her lower legs from her knees down/tingling cool sensation in elbow and forearm; she has been tired; This is a spontaneous report from a contactable consumer or other non health care prfoesssional. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EM9810 ), dose 2 via an unspecified route of administration on 15Feb2021 ( at the age of 50 years old) at 11:34 in the afternoon as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2(PFIZER-BIONTECH m-RNA COVID-19 VACCINE, Lot number EL9262, expiry date: not reported) via unspecified route on 25Jan2021 as dose 1, single for COVID-19 immunization and experienced tired which she noticed with the first one too.She also did after the first dose, and she already reported that.The patient experienced tingling cool sensation in her lower legs from her knees down/tingling cool sensation in elbow and forearm, she has been tired on 15Feb2021 . Her doctor did give her the okay for the second vaccine because she didn't have a major side effect to the first dose. She did not have an anaphylactic reaction. Her doctor did tell her to stay an hour instead of 30 minutes. She stayed for an hour. This time instead of the side effect coming on in 10 minutes like the first vaccine, it came on in 20 minutes. It was a tingling cool sensation in her lower legs from her knees down. Then a minute or so after the tingling and cool sensation started in her elbow and forearm. The forearm lasted maybe 20-30 seconds. The tingling in legs lasted a little longer. The doctor gave her hydroxyzine which is a medication for anxiety and it actually acts like a Benadryl. So it was kind of a two for one. She did take that 35minutes after getting the vaccine. It seemed to help a lot. She stayed an hour, and was fine. Four hours later, just to be safe, she took two over the counter Benadryl. She was basically fine. The next day, she didn't get flu like symptoms. She heard that is common, but she didn't have anything like that. For 2-3 days after she has been tired which she noticed with the first one too. When she checked out, the nurse told her people that day reported the same thing. Other reported that cooling tingling sensation some even reported numbness. The first time a different nurse told her the same thing. No further details provided. She was not taking any Benadryl or hydroxyzine. She is feeling 80% back to normal. The patient enquired She called the doctor, and the asked the nurse when she would technically be fully vaccinated and the nurse said 14 days, but Pfizer said 7 days, and so did someone else. Which was true.Caller was informed Medical Information's information comes from the product insert.The patient was recovered completely from tingling cool sensation in her lower legs from her knees down/tingling cool sensation in elbow and forearm on 15Feb2021. The patient was recovering from she has been tired. Follow-up attempts completed. No further information expected.
50 2021-07-11 tingling Occasional Tingling in all extremities 6 days after 2nd dose
50 2021-07-11 throat numbness, tremor, muscle twitching Following administration of Pfizer Covid vaccine, dose #1, pt. experienced hive-like rash with signi... Read more
Following administration of Pfizer Covid vaccine, dose #1, pt. experienced hive-like rash with significant shaking. Symptoms began within 5 min of admin. Breath sounds clear and equal bialt. B/P-170/92, P-124, R-18, SaO2-99%. c/o tingling and numbness on lips, progressing to tongue and back of throat. Patient transported to ED, where she was noted to have twitching of her right leg, perioral numbness, and a change in sensation of her face, as well as a urticarial rash to bilateral upper back and shoulders. Patient received 50mg PO benadryl and 20mg PO famotidine. She was observed for ~90 minutes and discharged with a prescription for an epi-pen and a referral to an allergist. She was instructed not to get the 2nd dose of vaccine until approved by her PCP or allergist.
50 2021-07-12 migraine Approximately two weeks after receiving my first COVID vaccine, the frequency, intensity and duratio... Read more
Approximately two weeks after receiving my first COVID vaccine, the frequency, intensity and duration of my migraines increased dramatically. For about 20 years I've had one or two migraine headaches per month, usually associated with my menstrual cycle. Since March 20th until now (July 13th) I have averaged 19 headache days per month. I have now been diagnosed with chronic migraine with a MIDAS score (Migraine Disability Assessment test) indicating severe disability.
50 2021-07-12 pain in extremity arm was sore; sore, kept getting jibby jabby pain; pain at the injection site and all the way down h... Read more
arm was sore; sore, kept getting jibby jabby pain; pain at the injection site and all the way down her arm; calcium deposit on her tendon/rotator cuff; her first Pfizer shot on 22Mar2021 and she has been having a problem with her arm/couldn't move her arm for 3 days; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injec-tion, Batch/Lot Number: ER8727; Expiry Date: unknown. ), dose 1 via an unspecified route of ad-ministration, administered in Arm Left on 22Mar2021 (at the age of 50-years-old) as dose 1, single for covid-19 immunisation. NDC number was unknown. The patient medical history was not reported. Family medical history relevant to ae was none. Caller initially stated she was maybe 160lbs, then states she is maybe 150-160lbs. She added that she gained a lot of weight with the lock down. The patient's concomitant medications were not reported. The patient takes no medications at all. No additional vaccines administered on Same Date of the Pfizer Suspect. She has never been vaccinated in her entire life, not even the flu shot. She is usually pretty healthy that's what makes her think this event came from the vaccine. Plus, she knows what her arm feels like and she knows it came from the vaccine, she doesn't care what anybody says. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine was administered to the patient. In Apr2021, the patient experienced arm was sore; sore, kept getting jibby jabby pain, pain at the injection site and all the way down her arm and calcium deposit on her tendon/rotator cuff and on 22Mar2021, the patient experienced her first pfizer shot on 22mar2021 and she has been having a problem with her arm/couldn't move her arm for 3 days. It was reported that the patient went and got her first Pfizer shot and she has been having a prob-lem with her arm. The second shot was on 19 Apr 2021. She reported that she didn't really get sick from the Pfizer shot at the time, but ever since she got the shot, her arm has never been the same. She complained about it every day, it was sore, She states she kept getting jibby jabs , she doesn't know how to describe it, other than jibby jabby pain. She still gets pain. She clarifies her arm is still sore where she had the vaccine, her arm has never been the same. The Patient clarified that the pain started later that evening after receiving the second shot, but she didn't think much of it. By night time, her arm was hurting. She clarifies by 8 or 9 o'clock that night, her arm was very sore and hurting. She said her arm never really was the same after that. The patient was crying because she couldn't get dressed or brush her hair due to her hair. Even when she was sitting at the table, she had to pick up her arm and move it. It was like her arm was dead because then she cried even harder thinking she had a dead arm. Finally, she went to the hospital because she couldn't take it anymore. Of course the hospital is quack, so they didn't know. They couldn't find anything so that is why they sent her to the orthopedic doctor. At the end of May, she was still having problems with it. Her arm got so bad, she couldn't move it for 3 days, and she actually thought she was having a stroke. She had to actually pick up her arm and move it. She couldn't get dressed. She couldn't wash her hair. She cried. She went to the hospital and as she was sitting there, she told them she felt like the pain was spreading all the way up her arm. She wanted to know if this was from the vaccine. She ex-plains the hospital didn't know. They took an x-ray, but didn't find anything in her arm. They referred her to an or-thopedic doctor. She states it has been like 24 days since she went to the first orthopedic doctor, and he told her she had a calcium deposit on her tendon/rotator cuff. She had to go get some ul-trasound shots to have it broke up. She had to call and make an appointment because she had to go see another orthopedic doctor for the shots. Her appointment was today and when she went there, it seemed like her arm was getting a little bit better, so the doctor said he wasn't going to do the shots. The doctor said he didn't want to shoot the shots into her if she wasn't in pain al-ready. She is wondering if this pain in her arm came from the COVID vaccine shot because her arm has never been this painful. Even though they found the calcium deposit, she still gets pain where the vaccine was, at the injection site. She still has pain that shoots down her arm. Even though she guesses the calcium deposit is healing, they never said anything about the vaccine. The caller states she thinks its coming from the vaccine because her arm has never been the same. Caller stated she does not really have a primary care. She does not have insurance. She is paying all of these bills by hand. Patient reported that she went running to the hospital because she was so scared. She couldn't wash her hair and move her arm for a few days, so she wasn't sure if it was coming from the vac-cine. The caller explains her sister kind of forced her into the vaccine. She kept telling her sister that she wasn't ready for the COVID vaccine because it wasn't FDA approved yet, but her sister forced her into it. She kept telling her sister that her arm hasn't been the same after the vaccine. Her arm still isn't the same, she still get pains in it. She said it is hard to describe the pain in her arm. Caller states sometimes it's feels like something is in there jibby jabbing her. Sometimes, pain just shoots through her arm. She couldn't move her arm for days. She couldn't wash her hair or anything. She couldn't lift it. She went running to the hospital and was told they didn't know what it was, and then she asked if it was from the vac-cine and they said they didn't know. So, they sent her to the orthopedic doctor. As she stated earlier, the doctor found a calcium deposit, but she doesn't know if that was part of the vaccine. She just knows her arm still hurts at the injection site where she got the vaccine and her arm has never been the same, it still isn't to this day. She still gets pain in it. She kept hoping it would go away, but it still hasn't. That's why she is re-porting now. The day after she got the second vaccine, her arm started hurting. It was really sore the next day and she knew it was supposed to be. The pain started too but she didn't think much of it. She figured it was because she just got the shot. It seems like it's still there and now she has the issue with the orthopedics and calcium deposits. She doesn't know if the calcium deposit could be coming from the vaccine because she was told it was from the tendon/ rotator cuff. However, she knows she still feels pain at the injection site itself and all the way down her arm. The orthopedic doctor believes the calcium deposits are healing on its own so that's why she didn't have to get the shots today. She really thinks the pain is from the vaccine, or at least some of it is. She states it was painful enough for her to go the hospital because she doesn't ever go to doctors or hospitals since she doesn't have insurance. She doesn't go unless she has severe pain, she tries to avoid it. The patient confirms she was not hospitalized, she just went to the emergency room and was only seen there. She couldn't move her arm or anything. When her husband saw her having to pick her arm up and move it, he actually thought she had a stroke and didn't know it. She confirms she told the hospital she believed it was from the vaccine but the hospital said they couldn't say that. They did an X-ray and they didn't see anything. She clarified her not being able to move her arm and wash her hair started at the end of the May, right when she went to the hospital. She believes it was 24May2021 or 28May2021 when she went to the hospital. She was crying. She couldn't move her arm. She couldn't wash her hair, get dressed. This pain has improved because she is now able to was her hair and get dressed. She still feels jibby jabby pains in it every now and then, she still feels the pain shoot down her arm at the injection site. The caller stated she has another sister with health conditions. Her sister with health issues got the vaccine and her arm wasn't even sore. She got sick the next day. Caller clarified that her sister was sick for a couple days with a sore throat and sniffles and that, but her arm wasn't sore at all because she laughed at the caller. The patient confirmed that she would like to know if this arm pain is normal after the COVID-19 vaccine. The patient underwent lab tests and procedures which included x-ray: didn't find anything in her arm. Outcome of the event limb discomfort was recovering and that of the other events were unknown. Information on the lot/batch number has been requested.
50 2021-07-12 pain in extremity Calcium deposit on her tendon/rotator cuff; She cannot move her left arm / She could not lift it; Sh... Read more
Calcium deposit on her tendon/rotator cuff; She cannot move her left arm / She could not lift it; She was crying; Pain at the injection site and all the way down her arm; Reported a "jibby jabby" pain on her left arm, the same arm where she got the vaccine; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second single dose via an unspecified route of administration, administered in arm left on 19Apr2021 (Batch/Lot Number: ER8734) for covid-19 immunisation at age of 50-year-old. The patient previously received fist single dose of bnt162b2 on 22Mar2021 (Lot: ER8727) at left upper arm at age of 50-year-old and having a problem with her arm. Medical history and concomitant medications were none. She took no medications at all. She stated she was usually pretty healthy. The patient reported a "jibby jabby" pain on her left arm in Apr2021, the same arm where she got the vaccine. She said that she cannot move her left arm because of the "unbelievable pain" that even made her cry in May2021. She described the pain as something intense that she cannot get dress, brush her hair or even apply a deodorant. She later visited an orthopedic specialist and calcium deposits was found on the rotor cap of her tendon. Her physician recommended that she got an ultrasound shot for today's appointment. However, findings showed that her arm was healing and that her physician did not see the need to proceed with the ultrasound shot. In line with this, caller would like to know if it is normal that this side effect has been on-going for 2 months since she last got the shot on 19Apr2021. She described that on some days it gets better but it is just this May that it felt a lot worse. Patient reported she may have a side effect from the Pfizer, but she was not sure. She went and got her first Pfizer shot on 22Mar2021 and she has been having a problem with her arm. The second shot was on 19Apr2021. She stated she did not really get sick from the Pfizer shot at the time, but ever since she got the shot, her arm had never been the same. She complained about it every day, it was sore, She stated she kept getting jibby jabs in in Apr2021, she did not know how to describe it, other than jibby jabby pain. She still got pain. She clarified her arm was still sore where she had the vaccine in in Apr2021, her arm had never been the same. At the end of May2021, she was still having problems with it. Her arm got so bad, she could not move it for 3 days, and she actually thought she was having a stroke. She had to actually pick up her arm and move it. She could not get dressed. She could not wash her hair. She cried. She went to the hospital and as she was sitting there, she told them she felt like the pain was spreading all the way up her arm. She wanted to know if this was from the vaccine. She explained the hospital did not know. They took an x-ray, but did not find anything in her arm. They referred her to an orthopedic doctor. She stated it has been like 24 days since she went to the first orthopedic doctor, and he told her she had a calcium deposit on her tendon/rotator cuff. She had to go get some ultrasound shots to have it broke up. She had to call and make an appointment because she had to go see another orthopedic doctor for the shots. Her appointment was today and when she went there, it seemed like her arm was getting a little bit better, so the doctor said he was not going to do the shots. The doctor said he did not want to shoot the shots into her if she was not in pain already. She was wondering if this pain in her arm came from the COVID vaccine shot because her arm had never been this painful. Even though they found the calcium deposit, she still got pain where the vaccine was, at the injection site. She still had pain that shoots down her arm. Even though she guessed the calcium deposit was healing, they never said anything about the vaccine. The patient stated she thought it was coming from the vaccine because her arm had never been the same. She added that she gained a lot of weight with the lock down. She said she went running to the hospital because she was so scared. She could not wash her hair and move her arm for a few days, so she was not sure if it was coming from the vaccine. The caller explains her sister kind of forced her into the vaccine. She kept telling her sister that she was not ready for the COVID vaccine because it was not FDA approved yet, but her sister forced her into it. She kept telling her sister that her arm hadn't been the same after the vaccine. Her arm still wasn't the same, she still got pains in it. The patient said it was hard to describe the pain in her arm. The patient said sometimes it felt like something was in there jibby jabbing her. Sometimes, pain just shoots through her arm. She could not move her arm for days. She could not wash her hair or anything. She could not lift it. She went running to the hospital and was told they did not know what it was, and then she asked if it was from the vaccine and they said they did not know. So, they sent her to the orthopedic doctor. As she stated earlier, the doctor found a calcium deposit, but she did not know if that was part of the vaccine. She just knew her arm still hurts at the injection site where she got the vaccine and her arm has never been the same, it still was not to this day. She still got pain in it. She kept hoping it would go away, but it still had not. The day after she got the second vaccine, her arm started hurting. It was really sore the next day and she knew it was supposed to be. The pain started too but she didn't think much of it. She figured it was because she just got the shot. It seems like it is still there and now she has the issue with the orthopedics and calcium deposits. She does not know if the calcium deposit could be coming from the vaccine because she was told it was from the tendon/ rotator cuff. However, she knows she still feels pain at the injection site itself and all the way down her arm. The orthopedic doctor believed the calcium deposits are healing on its own so that is why she did not have to get the shots today. The patient really thought the pain was from the vaccine, or at least some of it is. She stated it was painful enough for her to go the hospital because she did not ever go to doctors or hospitals since she does not have insurance. She did not go unless she has severe pain, she tried to avoid it. The patient confirmed she was not hospitalized, she just went to the emergency room and was only seen there. She could not move her arm or anything. When her husband saw her having to pick her arm up and move it, he actually thought she had a stroke and did not know it. She confirms she told the hospital she believed it was from the vaccine but the hospital said they could not say that. They did an X-ray and they did not see anything. She clarified her not being able to move her arm and wash her hair started at the end of the May2021, right when she went to the hospital. She believed it was 24May2021 or 28May2021 when she went to the hospital. She was crying. She could not move her arm. She could not wash her hair, get dressed. This pain had improved because she was now able to was her hair and get dressed. She still felt jibby jabby pains in it every now and then, she still felt the pain shoot down her arm at the injection site. The outcome of event crying was unknown, while recovering for other events. Follow-up attempts are completed. No further information is expected.
50 2021-07-13 slurring Multiple complaints: arms turned red when going to bathroom. Went home and felt tire for next 4 days... Read more
Multiple complaints: arms turned red when going to bathroom. Went home and felt tire for next 4 days. 5 days later she had a syncipal event. AMS, BP was 70/50, slurring words. Went to ER - negative CT, MRI, EKG, given 5 bags of fluid. Went home with no dx and slept for 14 hours. woke up with facial swelling. Still has swelling of the arms and hands and a lacy rash. continued fatigue and joint pain.
50 2021-07-13 tingling, pain in extremity headache, face tingling,arm extra sore. upset stomach (probably my nerves because I was scared to ge... Read more
headache, face tingling,arm extra sore. upset stomach (probably my nerves because I was scared to get shot due to losing alot of family to covid19),dizzy- next day
50 2021-07-13 tingling Pins and needles (tingling) sensation on both hands and both legs from the knee down.
50 2021-07-14 numbness Lost taste& smell for four days after. Then since then my hands fingers feet and toes go numb. At ti... Read more
Lost taste& smell for four days after. Then since then my hands fingers feet and toes go numb. At times my whole body feels like it?s vibrating. I have ringing in my ear as well.
50 2021-07-14 pain in extremity, electric shock sensation, seizure The first day after vaccination I started to feel tightness of chest, a short time later I started h... Read more
The first day after vaccination I started to feel tightness of chest, a short time later I started having dry mouth and I could not swallow correctly. I started feeling overly tired and difficulty breathing and swallowing became worse. The signs and symptoms appeared gradually and slowly. It was about a 2 hour duration from the start of the symptoms until I took BENADRYL and then I felt a little better. During the third day, I started having seizures, which I had already stopped having for approximately two months before the vaccination, they appeared once again. When the seizure would end my chest felt tight and with difficulty breathing. I have a lot of pain and sensation of electric shock on vaccination arm.
50 2021-07-14 pain in extremity One week after injection, server pain on the whole left arm, arm pit, and back shoulder blade. The p... Read more
One week after injection, server pain on the whole left arm, arm pit, and back shoulder blade. The pain has not gone away.
50 2021-07-14 cold extremities 50-year-old female while in observation presented with c/o localized burning and swelling on the lef... Read more
50-year-old female while in observation presented with c/o localized burning and swelling on the left arm at the site of injection approximately 5-10 minutes after receiving the first dose of Pfizer. EMS was alerted and patient was then evaluated and observed. Patient's left upper arm continued to swell to her hand and fingers which then progressed to a bluish tint and feel cold to the touch. Patient was recommended to be transported and evaluated further Hospital. Initial Vitals: HR- 74; BP- 183/105; O2 Sat- 98%; RR 22; Discharge Vitals: HR-75; BP- 142/88; O2 Sat-96%; RR-16
50 2021-07-15 pain in extremity The day after the vaccine I had full body aches, nausea, chills and swollen lymph nodes (left axilla... Read more
The day after the vaccine I had full body aches, nausea, chills and swollen lymph nodes (left axillary & inguinal area). Everything except for swollen lymph nodes was gone in 4 days. The biggest complication is the swollen lymph nodes and an ache in my arm. The ache feels like a tourniquet is on my arm. I just had an ultrasound for my swollen lymph nodes. I saw my primary doctor on 6/23/21. I saw my gynecologist on 6/18/21.
50 2021-07-16 flushing Breathing became labored, felt like throat was closing, vomited, heart palpitations, felt tight, flu... Read more
Breathing became labored, felt like throat was closing, vomited, heart palpitations, felt tight, flushed Used epi pen immediately, taken down the hall to the Emergency Dept. Given another course of epi and IV, able to go home after 4 hours.
50 2021-07-16 pain in extremity, muscle twitching, hot flush Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with c... Read more
Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash. Fever didn't go away unitl 7/12 evening, chills were gone but all other symptoms stay. Since 7/8, also developed painful sore throat and canker sore on tongue. Dizziness is constant since day (7/7). On 7/14, had sudden increased dizziness, scalp twitching/headche, ring in left ear and sharp ear pain from right ear, right face hot to touch, almost fainted. Saw Internal doctor on 7/15, was diagnosed as Vestibular Neuronitis. Til today, I have constant dizziness, headache with scalp twitching, ear pain and right face hot to touch.
50 2021-07-17 burning sensation, pain in extremity, weakness, muscle spasms muscle in right leg and bottom foot hurt her for and on achy almost like slight Muscle cramp and fel... Read more
muscle in right leg and bottom foot hurt her for and on achy almost like slight Muscle cramp and felt weakness; muscle in right leg and bottom foot hurt her for and on achy almost like slight Muscle cramp and felt weakness; muscle in right leg and bottom foot hurt her for and on achy almost like slight Muscle cramp and felt weakness; right big toe and index felt burning on and off for days/Feel burning but those toes once in a while; Still have right leg pain on calf and under knee and upper leg; This is a spontaneous report from a non-contactable consumer. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Ew0150), via an unspecified route of administration on 11Apr2021 at 09:45 (at the age of 50-year-old), as dose 2, single in left arm for COVID-19 immunization at hospital. The patient's medical history included migraine and had allergies for penicillin. Concomitant medications within 2 weeks of vaccination included magnesium, ibuprofen (ADVIL 12 HOUR), atorvastatin one pill; all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Ep7534), via unspecified route of administration on 21Mar2021 at 09:45 (at the age of 50-year-old), as single dose in left leg for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021 at 08:00, after the administration of second dose of vaccine, the patient muscle in right leg and bottom foot hurt her for and on achy almost like slight muscle cramp and felt weakness. Third day same with leg and right arm. Fourth day felt muscle pain but not weakness, but right big toe and index felt burning on and off for days. The patient reported that months later now it was July and still had right leg pain on calf and under knee and upper leg. The patient felt burning but those toes once in a while. Adverse event result in Emergency Room visit. Patient had Doppler Ultrasound as treatment for the events. The patient underwent lab tets and procedures which included SARS-CoV-2 test (nasal swab): negative on 11May2021. The patient had COVID prior vaccination and was tested COVID post vaccination. The clinical outcome of all the events was not resolved. No follow-up attempts are possible. No further information is expected.
50 2021-07-17 burning sensation Burning sensation in mouth; Several canker sores; Red spots in mouth; inflammation on throat; Sore t... Read more
Burning sensation in mouth; Several canker sores; Red spots in mouth; inflammation on throat; Sore throat; Lymph glands swollen; sore on the neck; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) in the right arm on 20Mar2021 at 17:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included controlled high blood pressure. The patient had a history of allergy to penicillin and sulfa. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and olmesartan (MANUFACTURER UNKNOWN) for high blood pressure. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 19:00, 5 days after the vaccination, the patient experienced burning sensation in mouth, several canker sores appeared on day 6, 7 and 8 (date of this report), red spots in mouth and appearance of inflammation on throat, sore throat, lymph glands swollen and sore on the neck. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events burning sensation in mouth, canker sores, red spots in mouth, inflammation on throat, sore throat, swollen lymph glands and sore on the neck was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
50 2021-07-17 cold sweat, feeling cold the Fluoxetine 30mg daily dose made concentrating on her work stuff harder; she felt more winded tod... Read more
the Fluoxetine 30mg daily dose made concentrating on her work stuff harder; she felt more winded today, and was trying to catch her breath when she went up the stairs; She said she was not able to work today. She clarified she does accounting work, and found she was not able to concentrate on numbers; she said she had a dull headache all day on 15Mar2021 that got worse by 7:30PM that night; the left side of her face felt cold; Tiredness; she had mild fatigue that started on Thursday (11Mar2021) and Friday (12Mar2021); Feverish; Cold; Clammy; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Right arm on 10Mar2021 (Age at Vaccination 50 years old) (Batch/Lot Number: EN6203) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included migraine from 2009 to 2010 Reported her migraines were more stressed triggered. She said she took migraine medication (Butalbital) as needed in the past, and it had been more than 2 years ago since she took the migraine medication. No further details provided, hormone replacement therapy from an unknown date. Concomitant medication included fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported. Treatment medication included the Bi-Est was a compounded cream, yesterday (15Mar2021) she took 1 Tylenol (clarified as Equate Brand generic Acetaminophen 500mg). She said she also drank 15 drops of CBN water soluble drops in water and then laid down. She said the CBN helped her sleep. The patient stated that she had her first Pfizer COVID-19 Vaccine dose on 10Mar2021 and had some side effects. She said today (16Mar2021) had been her worse day. She said she had a really bad headache last night (15Mar2021), saying the headache was almost a migraine. She said the headache was concentrated on the left side of her head, behind her left eye. She clarified she had no headache today. She said the left side of her face felt cold, but not the right side of her face. She clarified the cold feeling she felt on the left side of her face was similar to the cooling effect felt when using mint toothpaste. She said she still felt a little cold feeling on the left side of her face today (16Mar2021). She said she was super tired today. She clarified she was tired after she got her COVID-19 Vaccine, and thought she was getting better on Saturday (13Mar2021) and Sunday (14Mar2021), but the tiredness hit again yesterday (15Mar2021), and increased today (16Mar2021). She said she felt more winded today and was trying to catch her breath when she went up the stairs. She said that was not normal for her. She said she had mild fatigue that started on Thursday (11Mar2021) and Friday (12Mar2021), and she suspected the fatigue might be from the COVID-19 Vaccine. She said she was not able to work today. She clarified she does accounting work, and found she was not able to concentrate on numbers. Caller asked if her side effects were normal symptoms of the COVID-19 Vaccine. The caller was advised she would be transferred to Pfizer Medical Information for further assistance. Reported she basically had everything listed on the Pfizer COVID-19 Vaccine side effect list, but a fever. She said she was on HRT (hormone replacement therapy) for menopause. She said she doesn't have hot flashes with HRT and was wondering if maybe that was why she didn't have a fever. Reported she had felt feverish, cold, clammy, and had chills off and on since she got the COVID-19 Vaccine. She clarified her symptoms were intermittent. She said she had mild nausea a couple days ago, and then again, yesterday, but the nausea was more noticeable yesterday. She said she drank more fluids to treat her nausea yesterday. The patient underwent lab tests and procedures which included body temperature: 98.1 on 16Mar2021. Therapeutic measures were taken as a result of she said she had a dull headache all day on 15mar2021 that got worse by 7:30pm that night (headache), the left side of her face felt cold (feeling cold), tiredness (fatigue), she had mild fatigue that started on thursday (11mar2021) and friday (12mar2021) (fatigue), she felt more winded today, and was trying to catch her breath when she went up the stairs (dyspnoea), she said she was not able to work today. she clarified she does accounting work, and found she was not able to concentrate on numbers (disturbance in attention), feverish (pyrexia), cold (nasopharyngitis), clammy (cold sweat), chills (chills) , nausea (nausea), the fluoxetine 30mg daily dose made concentrating on her work stuff harder (disturbance in attention). Outcome of the event headache was recovered on 16Mar2021, nausea was recovered on Mar2021, feeling cold was recovering, Tiredness, fatigue, dyspnoea, disturbance in attention, pyrexia, disturbance in attention, cold sweat, chills was not recovered, disturbance in attention was unknown. No follow-up attempts are possible. No further information is expected.
50 2021-07-17 concussion Experiencing erratic heartbeats, tachycardia and bradycardia for months after the first injection. E... Read more
Experiencing erratic heartbeats, tachycardia and bradycardia for months after the first injection. Experienced syncope during a phase of rapid heart rate the day after the first injection. (Got a concussion after passing out.)
50 2021-07-17 muscle spasms chills; fever; itching on bottoms of feet; dyshidrotic dermatitis flare; muscle spasms in all extrem... Read more
chills; fever; itching on bottoms of feet; dyshidrotic dermatitis flare; muscle spasms in all extremities and fingers,but intense in the right leg,; nausea; stuffiness; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via an unspecified route of administration in the left arm on 29Mar2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included dyshidrotic dermatitis, attention deficit hyperactivity disorder and childhood history of kidney issues. The patient had known allergies to numerous antibiotics, codeine, peanuts, walnuts, and pecans. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), from unknown date and for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via an unspecified route of administration in the left arm on 08Mar2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Jan2021, at 00:00 the patient experienced chills, fever, itching on bottoms of feet (dyshidrotic dermatitis flare), muscle spasms in all extremities and fingers, but intense in the right leg, stuffiness, and nausea. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, fever, itching on bottoms of feet (dyshidrotic dermatitis flare), muscle spasms, stuffiness, and nausea were not recovered. No follow-up attempts are needed. No further information is expected.
50 2021-07-17 night sweats Fever, chills, body aches, night sweats for nine days that started June 21, 2021 after vaccine. Nex... Read more
Fever, chills, body aches, night sweats for nine days that started June 21, 2021 after vaccine. Next day had severe panic attack. Went to see Primary physician and he prescribed Xanax. I?m taking a full Xanax at night and sleeping okay. During the day panic attacks are continuous causing me to loose two weeks work. Still on Xanax and no relief. Went to ER for this issue. Labs and ekg were fine, but still not feeling well. Prior to first dose of Pfizer, no issues with panic attacks.
50 2021-07-17 pain in extremity, flushing cheeks felt hot; dry mouth; Both arm pain; hives where got vaccine; This is a spontaneous report fro... Read more
cheeks felt hot; dry mouth; Both arm pain; hives where got vaccine; This is a spontaneous report from a non-contactable consumer nurse (patient). A 50-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID 19 VACCINE, Formulation: solution for injection, Lot Number Ep7534, Expiration date: not reported) via an unspecified route of administration in Leg Left on 21Mar2021 (age at vaccination 50-years-old) at 09:45 AM as DOSE 1, SINGLE for covid-19 immunization. Medical history included covid-19 on an unknown date (prior vaccination), migraine and had allergies for penicillin from an unknown date and unknown if ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included magnesium, ibuprofen (ADVIL [IBUPROFEN]) and atorvastatin 1 pill taken for an unspecified indication, from an unknown start date. On an unspecified date in Mar2021, the patient experienced both arm pain, hives where the patient got vaccine and Cheeks felt hot, dry mouth on 22Mar2021. On 11May2021, the patient underwent lab test and procedures which included Nasal Swab (Sars-CoV-2 test) was negative. The events was reported as non serious. The outcome of the events was reported as unknown. No follow-up attempts are possible. No further information is expected.
50 2021-07-17 pain in extremity, migraine This is a spontaneous report from a contactable other healthcare professional, the patient. A 50-yea... Read more
This is a spontaneous report from a contactable other healthcare professional, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration in the left arm on 19Mar2021 at 14:00 (at the age of 50-years-old), as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the day after injection, the patient experienced, soreness in arm, headache and fatigue and one week and one day after injection the patient experienced migraine headache. The adverse events resulted in an emergency room visit or department urgent care visit and treatment was received for the adverse events. The clinical outcomes of soreness in arm, headache, fatigue and migraine were unknown, at this time of report. No follow-up attempts are needed. No further information is expected.
50 2021-07-17 pain in extremity Severe auto immune response including rheumatoid arthritis, inflammation (blood test confirmed), iri... Read more
Severe auto immune response including rheumatoid arthritis, inflammation (blood test confirmed), iritis, Necrobiosus. In addition to severe joint pain in upper body including arms, neck and back.; Severe auto immune response including rheumatoid arthritis, inflammation (blood test confirmed), iritis, Necrobiosus. In addition to severe joint pain in upper body including arms, neck and back.; Severe auto immune response including rheumatoid arthritis, inflammation (blood test confirmed), iritis, Necrobiosus. In addition to severe joint pain in upper body including arms, neck and back.; Severe auto immune response including rheumatoid arthritis, inflammation (blood test confirmed), iritis, Necrobiosus. In addition to severe joint pain in upper body including arms, neck and back.; Severe auto immune response including rheumatoid arthritis, inflammation (blood test confirmed), iritis, Necrobiosus. In addition to severe joint pain in upper body including arms, neck and back.; Severe auto immune response including rheumatoid arthritis, inflammation (blood test confirmed), iritis, Necrobiosus. In addition to severe joint pain in upper body including arms, neck and back.; Severe auto immune response including rheumatoid arthritis, inflammation (blood test confirmed), iritis, Necrobiosus. In addition to severe joint pain in upper body including arms, neck and back.; Severe auto immune response including rheumatoid arthritis, inflammation (blood test confirmed), iritis, Necrobiosus. In addition to severe joint pain in upper body including arms, neck and back.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in left arm on 14Apr2021 (at 08:00) (age at vaccination was 50 years) (Batch/Lot Number: Er8729) as dose 1, single for covid-19 immunization. The patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in right arm on 31May2021 (at 08:00) (age at vaccination was 50 years) (Batch/Lot Number: Ep7534) as dose 2, single for covid-19 immunization.Medical history included colitis ulcerative from an unknown date. Concomitant medications included infliximab (REMICADE), mesalamine (MESALAMINE), venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26May2021 (at 11:00) the patient experienced severe auto immune response including rheumatoid arthritis, inflammation (blood test confirmed), iritis, Necrobiosus. In addition to severe joint pain in upper body including arms, neck and back. The patient received prednisone as the treatment for the events. The event rheumatoid arthritis was considered as medically significant. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. The outcome of all the events was resolving. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021828042 similar report from same reporter
50 2021-07-18 breast pain, facial pain, pain in extremity Headache, unable to sleep at night, back pains, pains in arm, body pain , pain in right breast, wake... Read more
Headache, unable to sleep at night, back pains, pains in arm, body pain , pain in right breast, wake up with pain on side of face, swollen lymph node in breast
50 2021-07-18 difficulty speaking Started with Sore throat one morning (Apr 14). Thought it was maybe seasonal allergies and post nasa... Read more
Started with Sore throat one morning (Apr 14). Thought it was maybe seasonal allergies and post nasal drip as the cause. took OTC meds and after 10 days, no change, went to GP, he gave me antibiotics since he saw fluid in my left ear. Voice was hoarse, but still there After 8 days on antibiotics, no voice. Next came steroid shots with another round of antibiotics. Finally got to an ENT, thought i was maybe acid reflux causing the inflammation around vocal cords. Prescribed omeprazole for 30 days no difference. Got a second opinion, this one thought Muscle tension dysphonia. 3rd ENT and 2 speech language pathologist later, paralyzed right vocal cord (at this point it's been 3 months).
50 2021-07-18 pain in extremity, migraine SO after the second shot I had a very sore left arm. Within six hours I had a lot of pain in all of ... Read more
SO after the second shot I had a very sore left arm. Within six hours I had a lot of pain in all of my joints and muscles. On day two I woke up with a fever of 102.1, a massive migraine and nausea, vomiting and that lasted for about three days. Around day four everything went away except the joint pain. My pain level is always between a 4-6 now, prior to that it was a 6-8 and that is when I sought treatment from a DR. I contacted my DR about a week after my vaccine. I saw a Rheumatologist and got blood work too. I also am having short term memory problems as well which has begun after the vaccine as well so I do not know the time frame too well of everything that has happened. I do have two DRs coming up for both wrists and my knee, those are to be scheduled. I have been issues with working as well. I am very fatigued, have issues with short term memory loss and work retrieval, issues getting dressed in the morning due to joints being cramped.
50 2021-07-18 pain in extremity, tingling Pain in both legs and feet. Tingling pain in hand and tips of fingers
50 2021-07-18 tingling, numbness major numbness, tingling left side of face, tops of feet, toes
50 2021-07-18 tingling, numbness Feb 15: Taking shower and all of a sudden legs became weak and I cannot stand up anymore. I crawled ... Read more
Feb 15: Taking shower and all of a sudden legs became weak and I cannot stand up anymore. I crawled ln the floor and used my upper extremities to sit up in a chair. Feb 16: Going to work as I was walking in the parking lot, all of a sudden, my knees gave out. I fell on my knees and unable to get up because both legs became weak. Mutiple falls after that. My legs gives out and becoming weaker and weaker. My mother stayed with me for assistance. March 20: Notified PCP on multiple falls and MRI was scheduled on April 5. March 21: mUltiple call in sick from work since Feb. March 21, I stopped working. April5: MRI dom=ne. My PCP called me in the evening after MRI to go to the ER due to MRI result. Admitted at Kaiser for 1 week. Multiple labs, test done during admission. When Discharged, My sister took me in Sacramento and gave up my apartment in Sunnyvale because I am now needing moderate assistance with transfer and ambulation. Now using walker and wheelchair. Dialysis was transferred to Sacramento. Sister and nephew transport me to dialysis. May 28: After dialysis, both legs were now non weight bearing to almost paralysis. Called 911. Admitted in Kaiser South Sacramento and stayed for 1 week. Neurology consult done. I was discharged in a rehab facility for physical therapy. Standing lift was used for transfer at the rehab center. May 20: admitted to hospital for IVIG treatment and discharged to home. Physical therapy is still being done with family assistance and until now, no progress. Upper extremities are also getting weaker, both hands numb and tingly, having a hard time holding spoon to eat. July 14: Lumbar puncture done.
50 2021-07-19 difficulty speaking, flushing Immediate allergic reaction to first dose of vaccine, tongue swelled, could not swallow, face hugely... Read more
Immediate allergic reaction to first dose of vaccine, tongue swelled, could not swallow, face hugely flushed, unusual allergic reaction compared to past. Was a drive-thru clinic in early January, and there were no medical staff present, no epi pen administered. 8 minutes later, the reaction began to pass, waited for another hour and the symptoms subsided somewhat. 3-4 swelling in neck, fatigue, issues affecting voice box, etc. Slowly has dissipated over time. Doctor recommended not to get the second vaccine, due to allergic reaction.
50 2021-07-20 weakness, numbness, tremor, tingling Systemic: "Guillan-Barre-like" but not assessed by professional-Severe, Systemic: Numbness (specify:... Read more
Systemic: "Guillan-Barre-like" but not assessed by professional-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient describes "Guillan-Barre-like", later stated she did not ever seek medical attention for her concerns. Reports mostly back to normal now. Pharmacist advised to follow-up with PCP (and that she should have as soon as she had effects)
50 2021-07-20 breast pain Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: SWOLLEN RIGHT BREAST ... Read more
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: SWOLLEN RIGHT BREAST WITH RASH RUNNING DOWN CENTER OF BREAST-Severe, Systemic: Lymph Node Swelling-Medium, Additional Details: POST MASTECTOMY RIGHT BREAST BECAME SWOLLEN WITH RED RASH RUNNING LENGTH OF RIGHT BREAST. "HARD AS A ROCK" SOME SWELLING OF LYMPH NODES AND SHARP PAIN
50 2021-07-21 cold sweat Nausea; vomiting; diarrhea; exhaustion; cold sweats; This is a spontaneous report from a contactable... Read more
Nausea; vomiting; diarrhea; exhaustion; cold sweats; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 at 14:00(at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history was not included. The patient did not have any allergies to medications, food, or other products. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN,18mg) from unknown date for unknown indication, ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, ergocalciferol, iron, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopheryl acetate (CENTRUM) from unknown date for unknown indication and collagen vi (MANUFACTURER UNKNOWN) from unknown date for unknown indication and multivitamin(MANUFACTURER UNKNOWN)from unknown date for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in right arm on 09Mar2021 at 14:00, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, at 16:00 the patient experienced nausea, vomiting, diarrhea, exhaustion and cold sweats for several hours. The patient did not receive any treatment for the reported events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea, vomiting, diarrhea, exhaustion and cold sweats were not resolved at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
50 2021-07-21 electric shock sensation As soon as I received the shot my arm felt like lightning went through it. I began having shortness ... Read more
As soon as I received the shot my arm felt like lightning went through it. I began having shortness of breath. I walked to get some water and started having more trouble breathing. I was sweating, I felt dizzy. The EMS came and took me to the hospital where I was for 4-5 hours. I was given Benadryl. I was going to get medicine for nausea, but I felt better and was afraid to take anything because of the reaction. I was very lightheaded, dizzy and nauseous. At the hospital, I was observed. I was getting better but I was still itchy. The Doctor was going to prescribe some prednisone but wanted to hold off on any medication to allow the vaccine to do its job. I was given a prednisone pack and a Benadryl pack. I felt better so I didn't take the prednisone. I was told to continue taking Benadryl and if that did not help, I was to take prednisone. Currently, I still experience extreme achiness and fatigue. This is something I have never experienced before. I am on medication for the achiness that my doctor believes to be arthritis but it is not helping. I was able to run 3 miles a day but now I am unable to even walk it. It is difficult getting up and down stairs which the medication has helped with some.
50 2021-07-21 pain in extremity the dose she received yesterday had expired by 30 minutes; moderate fatigue; diarrhea; lot of pain i... Read more
the dose she received yesterday had expired by 30 minutes; moderate fatigue; diarrhea; lot of pain in her arm, moderate pain in her arm; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a 50-year-old female patient (reporter's wife). A 50-years-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 05Jul2021 (50-years-at the time of vaccination), (Batch/Lot Number: EWB171) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, "My wife got the Pfizer BioNTech Covid 19 vaccination yesterday, she had moderate fatigue, diarrhea and a lot of pain in her arm, moderate pain in her arm, now today was the day at pharmacy where was get her vaccination at, said that the vaccine that she got yesterday was expired 30 minutes, it was 30 minutes then she was given a next shot and she was and it was like that after the pharmacy tonight to get another shot and what I am concerned about is before her reaction been worse after giving the 2nd shot." Reporter was informed about the Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday as per EST. The clinical outcome of the events was unknown. Further probing could not be done as reporter don't want to share further information. Hence, limited information available over the call.
50 2021-07-21 tingling, feeling hot Fatigue after 5 hours of receiving vaccination, fever, chills, face felt hot as if face was sun burn... Read more
Fatigue after 5 hours of receiving vaccination, fever, chills, face felt hot as if face was sun burned, tingly and burning feeling on skin, sweating, increased nausea, sinus congestion, chest congestion, decreased appetite, cough, lower abdominal pain, change in bowel movements, breathing became shallow and fast, headache, light headed.
50 2021-07-22 inability to speak Twenty minutes after pfizer was administered, pt felt her throat closing and was unable to talk. O2 ... Read more
Twenty minutes after pfizer was administered, pt felt her throat closing and was unable to talk. O2 sat on RA was 81, HR 79. Epinephrine immediately administered and 911 called. Pt place on 15 L non rebreather. Pt O2 sats increased to 100% . HR 120. Paramendics arrived at 10:32 and took over care, transported by ambulance to ER.
50 2021-07-22 pain in extremity Patient came into clinic today around 2:15pm on 07/23/2021 and informed staff that within 24 hours o... Read more
Patient came into clinic today around 2:15pm on 07/23/2021 and informed staff that within 24 hours of receiving dose #2 Pfizer COVID-19 vaccine that she experienced Left arm pain, swelling to her left shoulder/neck area that last 2 days, a d fever times 1 day and nausea times 1 day. Patient stated that swelling went away after 2 days.
50 2021-07-22 tingling Chills; nausea; severe vomiting; diarrhea; chest pain; shortness of breath; tingling on fingers; hea... Read more
Chills; nausea; severe vomiting; diarrhea; chest pain; shortness of breath; tingling on fingers; headache; fever; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8732) via an unspecified route of administration, administered on the right arm on 26Mar2021 12:45 as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. No known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC), fish oil (OMEGA 3 FORTE [FISH OIL]) and birth control pill. The patient previously received first dose of BNT162B2 on 07Mar2021 for COVID-19 immunisation (at 09:00 PM, Lot number: ER8732). On 26Mar2021 22:00, the patient experienced chills, nausea, severe vomiting, diarrhea, chest pain, shortness of breath, tingling on fingers, headache, fever. The events resulted in Emergency room/department or urgent care visit. Therapeutic measures were taken as a result of the events which included IV fluids, EKG (unknown result), chest X-ray (unknown result) and nausea medicine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
50 2021-07-22 tenderness, pain in extremity had the Pfizer Vaccine on 22Mar2021 and had the 2nd dose of the vaccine today; a little soreness in ... Read more
had the Pfizer Vaccine on 22Mar2021 and had the 2nd dose of the vaccine today; a little soreness in the arm from getting the shot; Hers is just a little tender; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0185), via an unspecified route of administration in the left arm on 09Jul2021 at 12:15 (at the age of 50-year-old) as dose 2, 0.3 ml single for COVID-19 immunisation in pharmacy. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 50-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that she was called about the Pfizer Vaccination and stated she and her husband both had the Pfizer Vaccine on 22Mar2021 and then had hesitancy about getting the 2nd dose of the vaccine but both she and her husband did get the 2nd doses of their vaccines today at "PRIVACY"; she had some question about the amount of time between the two doses of the Pfizer Vaccines for herself and for her husband about whether or not they were within the amount of time Pfizer recommends and to they need to start over with the 2nd shots being their 1st shots. Caller said that she was having a little soreness in the arm from getting the shot. She said that her husband does not even have that. She was just a little tender. She wanted to know "Has Pfizer provided a statement on the need for a booster dose (3rd dose) and Is Pfizer investigating the need for a booster dose. Response: As part of Pfizer's and BioNTech's continued efforts to stay ahead of the virus causing COVID-19 and circulating mutations, the companies provided an update on booster dosing on 09Jul2021. Please note that the use of a 3rd or booster dose is not recommended or authorized, and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information authorized product monograph. Initial data from the ongoing study of booster doses demonstrated a consistent tolerability profile and high neutralization titers against the wild-type virus (the naturally occurring non-mutated virus) and the Beta variant. It was thought that the effects seen against the Beta variant may also be seen in the Delta variant. We are doing studies to confirm this. We expect to publish the data soon in a peer-reviewed journal and submit to regulatory authorities like the FDA in the coming weeks. The adverse events did not result in visit to emergency room and physician office. The outcome of the events was not resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021868964 Same product and event, different patients
50 2021-07-22 tremor lightheaded; muscles shaky; nauseous; This is a spontaneous report from a contactable consumer, the ... Read more
lightheaded; muscles shaky; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration, in the left arm on 03Apr2021 at 12:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included bisoprolol fumarate (ZEBETA), escitalopram oxalate (LEXAPRO), atorvastatin calcium (LIPITOR), buspirone hydrochloride (BUSPAR) and hydrochlorothiazide (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. The patient previously received epinephrine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Apr2021 at 12:45, five seconds after vaccination, the patient felt lightheaded, muscles were shaky and nauseous. Felt this intensely for two hours and then it lessened but still felt sick. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of lightheaded, tremor muscle and nausea were recovered with sequelae on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
50 2021-07-25 migraine, pain in extremity I had side effects from shot; Fatigue, body aches, sore arm 1. On May 3rd after going almost 2 yrs w... Read more
I had side effects from shot; Fatigue, body aches, sore arm 1. On May 3rd after going almost 2 yrs without a migraine I had a migraine without Aura (I always get Aura) that lasted 3 days. 2nd Migraine came May 18th. Was also having multiple headaches through the weeks. 2. Started my period on March 22nd and it lasted 5 weeks non stop w/medium to heavy flow. Finally it ended on April 26th. Spoke with a friend & she had the Pfizer vax with same long cycle of multiple weeks. At current I haven't had a period. Prior I had blood work to confirm I was not in Menopause. 3. Tinnitus-6 wks as of today. I have had ringing in my ears. Started off it only happened now and then for short periods of time. Now I have it everyday
50 2021-07-25 muscle spasms, numbness, breast pain, pain in extremity INTENSE pain left side under arm, down around left backside, left breast, numbness in fingers, weakn... Read more
INTENSE pain left side under arm, down around left backside, left breast, numbness in fingers, weakness in left arm, inability to use left arm and left hand for over two months. Spasms would come and go that were so intense that it left me almost fully incapacitated coping with the pain that accompanied them. The pain was almost non-stop keeping me awake unable to navigate my days either. Currently, in the end of July, I almost have full feeling back in my left hand fingers but still experience intermittent spasms that are less intense and painful n my left breast, under my left arm and the site of the injection.
50 2021-07-26 flushing Pt. states that after receiving the 1st dose of Phizer 07/06/2021 started experiencing feeling flush... Read more
Pt. states that after receiving the 1st dose of Phizer 07/06/2021 started experiencing feeling flushed and loose stool ending 07/24/2021. Experienced dehydration but maintained appetite. Scheduled for 2nd dose 07/27/2021
50 2021-07-26 muscle spasms, facial pain, breast pain, tingling APPROXIMATELY 5 TO 10 MINUTES AFTER SHOT, PATIENT COMPLAINED OF CRAMPING/PAIN IN FACE AROUND EAR. SW... Read more
APPROXIMATELY 5 TO 10 MINUTES AFTER SHOT, PATIENT COMPLAINED OF CRAMPING/PAIN IN FACE AROUND EAR. SWELLING AT BASE OF NECK AND BURNING IN CHEST AND BREAST AND TINGLING IN FINGERS AND HAND, ALL OF THIS ON LEFT SIDE WHERE SHOT WAS ADMINISTERED. PATIENT GIVEN AN ICE PACK TO APPLY TO SWELLING AND OBSERVED FOR AT LEAST 30 MINUTES. SWELLING WENT DOWN, PATIENT WAS OFFERED BENADRYL BUT DID NOT WANT TO TAKE UNTIL SHE GOT HOME. NO DIFFICULTY BREATHING OR PRESSURE IN CHEST. NO CHANGE IN MENTAL OR ALERT STATUS.
50 2021-07-26 pain in extremity Inflammation throughout entire body, arthritic response in 2 fingers on right hand, pain in both upp... Read more
Inflammation throughout entire body, arthritic response in 2 fingers on right hand, pain in both upper thighs, at times to the point I could not stay still, Significant change in thyroid function lab tests. Extreme fatigue and continuous headaches.
50 2021-07-26 tingling, muscle twitching, numbness Off balance feeling, right eyelid twitching, tingling in hands, tingling in feet, numbness in hands ... Read more
Off balance feeling, right eyelid twitching, tingling in hands, tingling in feet, numbness in hands and feet, burning sensations in skin, headaches, neck ache, muscle twitches in body.
50 2021-07-26 tingling Post vaccination, patient reports: palpitations, sweating dizziness, right sided chest tightness, dr... Read more
Post vaccination, patient reports: palpitations, sweating dizziness, right sided chest tightness, dry mouth, tingling on upper and lower extremities. PT reports receiving Tdap 7 days prior to second dose Pfizer vaccination.
50 2021-07-27 weakness, difficulty speaking, speech disorder injection site painful; Muscle pain; tiredness; felt drained of energy/weak; joint pain; that felt l... Read more
injection site painful; Muscle pain; tiredness; felt drained of energy/weak; joint pain; that felt like it was down to the bone marrow; swelling of lymph nodes in neck; Hoarseness; chills; fever; sore throat/throat soreness; vaccine made her sick as a dog; had the shits; she cannot even talk right; head and throat it feels swollen up; head and throat it feels swollen up/her throat was swole; I have, I called in, I do not remember yesterday, day before yesterday I believe. I do not remember what day it was; vision is blurry; This is a spontaneous report from a contactable consumer or other non-Health Care Professional (patient) via medical information team. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0186 and Expiry date: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 12:23 (at the age of 50-years-old) as dose 1, single for Covid-19 immunization in Vaccination Facility Type School/Student Health Clinic. The patient medical history included 12 broken ribs, family medical history and concomitant medications were reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no problems with vaccines in past. The patient was not diagnosed with covid 19 and has not been tested for COVID-19 Since the vaccination. It was reported that patient experienced severe side effects after receiving first dose of vaccine. On an unspecified date in 2021, the patient experienced vaccine made her sick as a dog, her throat was swole, she cannot even talk right, Vision was blurry it was going and coming she never had a problem with my eyes, had the shits. On May2021 the patient experienced chills, fever, joint pain; that felt like it was down to the bone marrow, swelling of lymph nodes in neck, hoarseness, throat soreness that made her feel like she had a cold or some allergies. She was sick like a dog, head and throat it feels swollen up. On 19May2021 the patient experienced injection site painful, muscle pain, tiredness, felt drained of energy/weak. Patient stated that "I have, I called in, I do not remember yesterday, day before yesterday I believe. I do not remember what day it was but this my head, is this, this feels really, my head and throat it feels swollen up and I feel weak and yes my vision is blurry it's going and coming I never had a problem with my eyes. I need to go to work." Regarding medication patient stated that "I was taking, I only took from a lady that tried to help and 'nothing happened itself' (not clear) I didn't took (voice incomprehensible), I didn't took, it seem like I got a cold or something I don't know what is it. It's like my sinus and all of it and all this other, It's got my swollen throat and all of it, it messes with my vision. I got my throat is swelled up, my throat is swelled up and I am just thinking about." The report was not related to a study or program. The patient questioned that was the Pfizer covid-19 vaccine prohibited but being given anyway. Patient stated she has not established a new doctor yet since moved. Was told that her arm was going to be painful after the injection and that was normal, but what she had was not normal and different from the sheet she was given. Had all those side effects except she did not get any headaches. All of these are gone except for the swelling on her lymph nodes in neck. Thought that was what has got her hoarse, was her lymph nodes in the throat swollen. It started with soreness and made her feel like she had a cold or some allergies. She was sick like a dog, but all that is gone today and she was starting to feel better, she just has the hoarseness. Started to feel better last night between 6-8pm and went to sleep about 8-8:30pm and did not wake up until this morning. She woke up this morning and all the symptoms even in the arm was better, but she was hoarse. Her throat was not sore anymore, but still has lymph node swollen in throat. Has not seen a provider or emergency care, states a family member cared for her. Patient did not visit emergency room or physician office. The seriousness was unspecified. No investigation assessment were done and relevant tests were none. The outcome of events was unknown. Follow up attempts are needed. Further information has been requested.
50 2021-07-27 numbness Breathlessness; Legs numb; Anxiety; This is a spontaneous report from a contactable consumer. A 50-y... Read more
Breathlessness; Legs numb; Anxiety; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:15 as DOSE 1, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Apr2021, after first shot 1 week later breathless ness and legs numb and went to ER. Thought it just an anxiety. Only after second shot realized more issues. Case was assessed as non-serious. There was no seriousness criteria-Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and Since the vaccination, was the patient did not diagnose with COVID-19. The outcome of the events was unknown. Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.
50 2021-07-27 pain in extremity, numbness, tingling, feeling hot Metal taste in throat and mouth; Heart rate up and racing; Blood pressure went up; Became hot; Nose ... Read more
Metal taste in throat and mouth; Heart rate up and racing; Blood pressure went up; Became hot; Nose tingling; Itchy nose; Numb nose; Chest tighten; Tired; Sore legs; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8729) via an unspecified route of administration in the left arm on 05Apr2021 at 09:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy NOS. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 09:30 the patient experienced metal taste in throat and mouth, heart rate up and racing, blood pressure went up, became hot, nose tingling, itchy nose, numb nose, chest tighten, tired and sore legs. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported adverse events. On an unknown date, the patient underwent heart rate and blood pressure test and the result was increased. The clinical outcome of the events metal taste in throat and mouth, heart rate up and racing, blood pressure went up, became hot, nose tingling, itchy nose, numb nose, chest tighten, tired and sore legs were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-27 pain in extremity mildly enlarged axillary lymph nodes; Pain radiating to entire arm and hand; Very intense pain at in... Read more
mildly enlarged axillary lymph nodes; Pain radiating to entire arm and hand; Very intense pain at injection site; Pain radiating to entire arm and hand; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL8982) via an unspecified route of administration in the left arm on 28Jan2021 at 14:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis and penicillin allergy. Concomitant medications were reported as not applicable. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248) via an unspecified route of administration in the left arm on 08Jan2021 at 14:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 29Jan2021 at 02:00, approximately 12 hours after injection of 2nd dose, the patient experienced very intense pain at injection site and the pain radiated to entire arm and hand. The intense pain persists at injection site over 2 months post injection. The pain in left arm was causing limited motion range. Occasionally mostly during the night, very intense pain reoccurs at the time of report. On an unknown date in Feb2021, the patient experienced mildly enlarged axillary lymph nodes. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On an unknown date in Feb2021 one week after 2nd dose, the patient underwent routing breast ultrasound screening and the result was mildly enlarged axillary lymph nodes. The clinical outcome of the events very intense pain at injection site, pain radiating to entire arm and hand, enlarged axillary lymph nodes was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-27 pain in extremity seeing fluid under her skin and having a "black and blue" where the injection was given; was concern... Read more
seeing fluid under her skin and having a "black and blue" where the injection was given; was concerned about the soreness to her arm; seeing fluid under her skin and having a "black and blue" where the injection was given; when she received the injection she is convinced that it was given subcutaneously versus in the muscle; This is a spontaneous report from a contactable other hcp (patient) via Pfizer sponsored program. A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: en6205) via subcutaneous on 20Mar2020 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a registered nurse and stated that she received her first vaccine dose on 20Mar2021 at clinic but when she received the injection, she was convinced that it was given subcutaneously versus in the muscle. She reported that afterwards she remembers seeing fluid under her skin and having "black and blue" where the injection was given. She had gone to see her HCP because afterwards she was concerned about the soreness to her arm along with the fact that she didn't think she got the injection performed appropriately. She received her second injection on 10Apr2021 in muscle (Lot: er8727) and it went fine but was worried as she was not fully protected and was wondering if she should do a booster. She asked what to be done about an invalid dose and also asked about the studies being done on the efficacy after receiving 1 dose and what type of tests regarding antibodies for the covid vaccine are recommended to check for immunity. She asked If there was any plan to train people further or better qualifying people on giving an IM injection. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
50 2021-07-27 pain in extremity Swollen lymph node in left armpit; Soreness in left arm; This is a spontaneous report from a contact... Read more
Swollen lymph node in left armpit; Soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on 28Apr2021 at 08:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW011A) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 16:30 the patient experienced swollen lymph node in the left armpit and soreness in the left arm. There was no information regarding the events whether resulted in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The clinical outcome of the events swollen lymph node in left armpit and soreness in left arm were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
50 2021-07-27 pain in extremity feet starting having problems; Peroneus Brevis; wisted my ankle which actually got rid of the pain f... Read more
feet starting having problems; Peroneus Brevis; wisted my ankle which actually got rid of the pain for a day; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Apr2021 (at age of 50 years old, no pregnant, Lot Number: EW0176) as a singled dose for covid-19 immunization. There were no medical history and concomitant medications. No known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at left arm on Apr2021 (Batch/lot number: CVS16506 EW0176) as a singled dose for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that 4 days after second dose on May2021, her feet starting having problems. The patient did treatment RICE. Thought it was plantar fasciitis ruled that out because it switched feet. She was a marathon runner (so in good shape). She had not upped her activity level. Hydrated. Nothing was working. Went to Dr, he thought it was Peroneus Brevis, did stretches etc, made it worse and twisted her ankle which actually got rid of the pain for a day and then was came back full force. The adverse event result in Doctor or other healthcare professional office/clinic visit. Received treatment included Stretching, RICE, Advil. Since the vaccination, the patient was not had been tested for COVID-19. The outcome of the events was not recovered.
50 2021-07-28 concussion I very rapidly lost consciousness and fainted. This happened 3 times in a 10 minute period as I was... Read more
I very rapidly lost consciousness and fainted. This happened 3 times in a 10 minute period as I was alone and unaware at the time of what was happening. My husband witnessed the third episode. My heart was racing at this time and I had broken out into a full sweat. After getting me into bed, with cold compress applied to my forehead, my symptoms seemed to resolve. We called my physician the next morning and they had me go into the office for a follow-up the following week. They diagnosed me with a concussion from repeatedly falling and hitting my head.
50 2021-07-28 hot flush, weakness Headache; Fatigue; Brain fog; Chills; Hot flashes; Nausea; Low Energy; Dizziness; This is a spontane... Read more
Headache; Fatigue; Brain fog; Chills; Hot flashes; Nausea; Low Energy; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke, on Nov2020 and seasonal allergy. The patient had known allergies to medications, food, or other products. The patient received medication (unspecified) within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 18:30, the patient experienced headache, fatigue, brain fog, chills, hot flashes, nausea, low energy and dizziness. Therapeutic measures were not taken for the adverse events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fatigue, brain fog, chills, hot flashes, nausea, low energy and dizziness was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-28 numbness, weakness left breast swollen; Numbness in both hands; Both hands swollen; Coughing; Super weak; Really tired;... Read more
left breast swollen; Numbness in both hands; Both hands swollen; Coughing; Super weak; Really tired; Severe headache; Left Armpit swollen and shooting pain; The shot site(upper left arm) started hurting within 12 hours and could not touch or sleep on left side; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the left arm on 04Apr2021 at 12:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient reported of no known allergies to medications, food, or other products. Concomitant medications included paracetamol (TYLENOL EXTRA-STRENGTH) and clonazepam (MANUFACTURER UNKNOWN) 1mg three times a day and more pharma (unspecified) for an unknown indication and from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 within 12 hours after vaccination, the patient experienced shot site hurting (upper left arm) and reported that she could not touch or sleep on the left side. The patient reported that it did hurt when she tried to use her left arm. On 05Apr2021 at 20:00, the patient experienced left armpit and breast swollen and shooting pain, numbness in both hands, both hands swollen, coughing, super weak, really tired and severe headache. It was unknown if any therapeutic measures were taken as a result of the reported events. The event resulted in doctor or other healthcare professional office/clinic visit on 06Apr2021 at 14:45. The clinical outcome of the event left armpit and breast swollen and shooting pain, numbness in both hands, both hands swollen, coughing, super weak, really tired, severe headache and shot site hurting were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-28 night sweats, migraine Severe migraines; Hormone fluctuations; Brain fog; Muscle weakness; Night sweats; This is a spontane... Read more
Severe migraines; Hormone fluctuations; Brain fog; Muscle weakness; Night sweats; This is a spontaneous report from a contactable consumer, the patient. A 50-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 at 11:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 25Mar2021 at 11:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 23:00 i.e. three days after the second dose, the patient experienced severe migraines, started experiencing night sweats, hormone fluctuations, brain fog and muscle weakness. This was still on going 10 days post vaccine. The clinical outcome of the events severe migraines, hormone fluctuations, brain fog, muscle weakness and night sweats were not recovered. No follow-up attempts are needed. No further information is expected.
50 2021-07-28 pain in extremity soreness under left arm with a 2 inch lump; soreness under left arm with a 2 inch lump; she also had... Read more
soreness under left arm with a 2 inch lump; soreness under left arm with a 2 inch lump; she also had muscle soreness in her left arm that had; This is a spontaneous report from a contactable consumer. A 50-years-old non pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unknown date), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 13:15(Age at vaccination 50 years old) (Batch/Lot Number: EN6207) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not received other medications the patient received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 Prior to vaccination, not tested positive for the covid-19. Patient was not allergies to medications, food, or other products. On 19Mar2021, the patient had her first Pfizer COVID-19 Vaccine 2 days ago on 17Mar2021. She said she had the COVID-19 Vaccine in her left arm. She said today (19Mar2021) she had a swollen lump in her left arm area that was about a 2 inch radius. She said she was calling to report her lump to Pfizer. On 17Mar2021, the patient also had muscle soreness in her left arm that had started overnight. Patient clarified the muscle soreness and swollen lump were under her left arm in her left armpit area. Outcome for the events limb mass¸ pain in extremity was not recovered, and for the event myalgia was unknown. No follow-up attempts are needed. No further information is expected.
50 2021-07-28 pain in extremity The first shot was March 23, 2021 and I woke up with extreme pain down my right leg that early morni... Read more
The first shot was March 23, 2021 and I woke up with extreme pain down my right leg that early morning after the shot. It eventually didn't ache as much until I received my second shot April 13 th and then both my legs started to ache badly mostly during the night. I now remember that my first shot was in my right arm and my second shot was in my left arm. I had my mammogram done April 15th and they recognized enlarge lymph nodes under my right arm. They immediately scheduled a biopsy because this was never in my medical history. I had to first get an ultra sounds and then a biopsy. My legs continued giving me pain so, my Dr. prescribed meds for the inflammation and recommended I get a doppler done on my legs. During the doppler the first part of June, they saw two other swollen lymph nodes on the left and right of my groin area. The right side was larger. So, I went back to my doctor and then he ordered a CT scan to be done to make sure the lymph nodes were not cancerous. I got the CT scan in July 26th and by that time the lymph nodes were no longer swollen. My scan was considered normal.
50 2021-07-29 weakness Hives, anxiety, sore throat, redness, weakness,
50 2021-07-29 tingling Lightheaded; Arms, upper chest, face, and eyelids became red; Felt tingling all over skin like she w... Read more
Lightheaded; Arms, upper chest, face, and eyelids became red; Felt tingling all over skin like she was going to get hives; Felt tingling all over skin like she was going to get hives; low grade fever; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9269), via an unknown route administered in the right arm, on 22Mar2021 (at the age of 50-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included COVID-19 from Mar2020 and hives in the past due to unspecified antibiotic. The patient did not have concomitant medications. Patient was vaccinated on 22Mar2021. Symptoms started the same day at 16:00. Patient felt lightheaded, her arms, upper chest, face, and eyelids became red; she felt tingling over her skin like she was going to get hives. These events were assessed as medically significant. Later in call the caller mentioned the patient also had a low-grade fever (non-serious). Patient never erupted into hives or had any itching. The patient was treated for diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC). Symptoms lasted about 24 hours and were gone the next day. However, the patient was considered recovered from the events 'lightheaded', 'arms, upper chest, face, and eyelids became red', and 'felt tingling all over skin like she was going to get hives' in Apr2021 (duration of the events was 21 days); the patient had recovered from the event 'low grade fever' on unknown date in 2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9269), via an unknown route administered in the right arm, on 17Apr2021 at single dose to completed COVID-19 immunisation.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the events Dizziness, Erythema , Paraesthesia Urticaria and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
51 2020-12-31 numbness, tingling About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and fe... Read more
About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and feeling tingling and maybe swollen, also, all of my regular pains in my body, ie. various mouth pains and said pains, certain things that act up in my body, were intensified and more bothersome, and I had a headache that wouldn't go away. I felt "off" that night and the next day. Probably like I was mildly sick and fatigued with body feeling sore all over and headachey. About 36 hours after getting the initial dose, I was feeling regular again.
51 2020-12-31 tenderness *12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, ... Read more
*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, with pain, on Right side of body with increased sensitivity at Left Axillary/side of breast area. Onset on 12/30 Fever, Severe Body aches/joint pain, dry cough, chest pain with min SOB, Headache. *Exposure to 4 people on Sat 12/26 who have tested positive for Covid on 1/1/20 but their symptoms began 12/28 through 01/30.
51 2021-01-03 numbness Ear pain pulling sensation, down my neck numbness jaw locking on same side of injection
51 2021-01-03 pain in extremity 20 minutes after receiving the vaccination the resident started to not feel well. She said she felt ... Read more
20 minutes after receiving the vaccination the resident started to not feel well. She said she felt very far away and just kept repeating I don't feel well. She was diaphoretic and her chest was very red and she kept scratching and rubbing it at it. I asked if she wanted IM Benadryl or epipen and she at first denied. She also said she felt like she needed to focus on her breathing. At this time we decided it was best to administer Epipen x 1 dose. Immediately after she felt better. She was observed for another 30 minutes and then went home. at 7:17pm I called and spoke with her. She said her arm was sore and that her oxygen levels were about 88-89% which is low for her but she said she felt fine and is currently working right now.
51 2021-01-04 feeling hot, numbness, tingling Within 10 minutes of vaccine administration, patient reported that her arm began feeling warm, she t... Read more
Within 10 minutes of vaccine administration, patient reported that her arm began feeling warm, she then had numbness and tingling in her face and reported her throat felt warm.
51 2021-01-04 flushing chest flushing; Racing heart rate; This is a spontaneous report from a contactable nurse (patient). ... Read more
chest flushing; Racing heart rate; This is a spontaneous report from a contactable nurse (patient). A 51-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in the left arm on 24Dec2020 11:30 at a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lysine hydrochloride, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, potassium iodide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acid succinate, zinc oxide (ONE A DAY MULTI VITAMIN & MINERALS). The patient did not receive other vaccine in four weeks. The patient previously took ephedrine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The patient experienced chest flushing and racing heart rate on 24Dec2020 11:45. Outcome of the events was recovered in Dec2020; no treatment was needed for the events. The events was assessed as non-serious.
51 2021-01-04 numbness, tingling Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clav... Read more
Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved; Experienced numbness and tingling in left arm on day 1 which resolved.; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 10:30 AM at left arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and known allergies to amoxicillin. The patient was not pregnant at the time of vaccination. The patient experienced numbness and tingling in left arm on day 1 (23Dec2020) which resolved in Dec2020. 3 days later noted left clavicular probable lymph node which is large and painful on 25Dec2020 07:00 PM. Possible neck lymphadenopathy as well. No treatment was received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events numbness and tingling in left arm was recovered in Dec2020. The outcome of the other events was not recovered. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about lot/batch number has been requested.
51 2021-01-04 numbness Numbness and tingling in arm and especially in fingers and hand of the vaccinated arm. Numbness for ... Read more
Numbness and tingling in arm and especially in fingers and hand of the vaccinated arm. Numbness for over 4 hours and continues at this time, but lessening. Numbness also felt on tip of nose- lasted an hour on tip of nose and then dissipated. No treatments provided only watched for anything worsening.
51 2021-01-04 migraine Migraines for several days, nausea on day three; nausea; This is a spontaneous report from a contact... Read more
Migraines for several days, nausea on day three; nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL0140), via intramuscular route of administration in the left arm on 18Dec2020 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included fibromyalgia and history of migraines. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 21Dec2020 at 13:00 the patient experienced migraines for several days, nausea on day three. The patient did not receive any treatment for the events. The clinical outcome of the migraines for several days, nausea on day three was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
51 2021-01-04 pain in extremity felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning ... Read more
felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning normally; This is a spontaneous report from a contactable nurse (reporting for herself). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left deltoid on 21Dec2020 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine. On 21Dec2020, the patient experienced left leg not functioning normally, which was reported with the seriousness criteria of disability. On 21Dec2020, the patient had itchiness in her head. The patient felt like she had a stroke, fell down and pain in leg on 22Dec2020, which were all reported with the seriousness criteria of disability. The patient called the doctor office and spoke with the doctor on call and was told to use diphenhydramine hydrochloride (BENADRYL). No further details provided. The patient was sent home for 10 days and she was sent back to work. The patient underwent lab tests and procedures which included COVID: negative in Dec2020. The outcome of the events was not recovered. The reported assessed the events related to the suspect product, BNT162B2.; Sender's Comments: The reported events leg dragging, leg pain and fall and suspected stroke were possibly related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, stroke was not diagnosed. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-01-04 tingling, numbness lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/... Read more
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
51 2021-01-04 tingling, numbness swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), to... Read more
swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ek5730, via an unspecified route of administration on 30Dec2020 at 12:00 (at the age of 51 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included lupus from an unknown date, and allergy to Celebrex (itching). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine, vitamin D3, and zinc, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 30Dec2020 at 14:30, the patient experienced swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands. The patient received treatment for the events which included Pepcid, Benadryl and prednisone. The clinical outcome of swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
51 2021-01-04 cold extremities, tingling tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands... Read more
tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands and feet are cold/She felt cold; This is a spontaneous report from a contactable nurse (patient). A 51 years old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 28Dec2020 10:00 at single dose in the arm left for covid-19 immunisation. Medical history included change in taste, altered taste. Concomitant medications were none. Caller reported she was having side effects with the COVID vaccine she received yesterday (28Dec2020) morning at 10am. The patient experienced paresthesia, tingling in hands and feet and they are cold, said she "felt cold" and has soreness in the injection site on 28Dec2020 17:00. Caller confirmed the above details. Her hands got really cold and tingling to them and she was wondering what this is and went to her other half and asked him to take a look. It passed and lasted about 10-15 minutes and just thought it was unusual. Did a 5:00pm check-in and she was doing okay and everything was fine so she didn't mention it. At 7:00pm she got tired and laid down and started feeling the tingling in the fingers and her hands. Upon waking this morning when her feet met the ground it was intensified, the tingling, and she went to walk it out it got better, but she is still having the tingling in both fingers/hands and feet. Stated unsure of seriousness criteria for the tingling in hands and feet and coldness. Wondered if it is something she needs to worry about that is why she called. Is it something that could go away or worse like with Guillain-barre syndrome. It's not disabling, but it is concerning. Unable to provide the NDC or expiry for COVID vaccine given. Stated she can't understand the writing on the card provided for her with product details. Does see on card Pfizer, X40113 and stated the lot number looks to be either "ES1685 or EJ1685 or E51685". Unable to provide the dose/strength. Received this vaccine at her workplace. Mentioned in past she had flu vaccine with the additive of mercury and experienced changes in taste, altered taste. It was reported to her primary care provider. This was between 6-8 years ago, unable to provide name of vaccine, NDC, Lot, or expiry. Since then she only receives single dose vials instead of multidose vials. They were looking for a list of side effects and wanted to know if she should seek care for her symptoms, it's unusual. Wanted to know if the side effects she is having is something Pfizer has been seeing and will it go away and when. Previous transfer agent sent her to safety. It is difficult to navigate the website. Outcome of event fatigue was unknown, while outcome of other events was not recovered. Causal relationship between vaccine and events "paresthesia, tingling in hands and feet" "hands and feet are cold" "soreness in injection site" were related by agency and Primary Source Reporter. Information about Lot/Batch number has been requested.
51 2021-01-05 weakness, tingling, pain in extremity felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling ... Read more
felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there. Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown. Information on the Lot/batch number has been requested.
51 2021-01-05 burning sensation Palpatations and systemic burning sensation. Lasted approx. 2 minutes then goes away; 2 episodes wit... Read more
Palpatations and systemic burning sensation. Lasted approx. 2 minutes then goes away; 2 episodes within 5 minutes of each other.
51 2021-01-05 cold sweat caller couldn't hear properly; got the Covid vaccine last 18Dec2020/her second dose of COVID-19 Vacc... Read more
caller couldn't hear properly; got the Covid vaccine last 18Dec2020/her second dose of COVID-19 Vaccine was scheduled on 06Jan2021; Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020; Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020; Nausea; Headache; Body aches; fatigue; Cold sweat; This is a spontaneous report from a contactable other health professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as either EK5730, ER5730, or EX5730), via an unspecified route of administration on 18Dec2020 16:00 at single dose at left deltoid for COVID-19 immunisation. Medical history and concomitant medications were none. The patient previously had shingles shot in Sep2020, previous shingles shot either three months or six months prior to the one in Sep2020 (2020), both for immunization, and severe myalgia and fever that lasted for two days after the second shingles shot (adverse events followed prior vaccinations). It was reported that did a callback as caller couldn't hear properly. Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020. Want to know if it's safe for her to get the second dose. The patient received Pfizer COVID-19 Vaccine on 18Dec2020 at 16:00. Patient had a couple days worth of symptoms. Now patient had COVID. Patient believed most likely got COVID from her son who was home from college. She was in between dosages of COVID-19 Vaccine. Looked like from research her quarantine would be done on 05Jan2021 and her second dose of COVID-19 Vaccine was scheduled on 06Jan2021. Everything she had read stated if her symptoms were gone to go ahead and get the second COVID-19 Vaccine. Patient wanted to know if Pfizer was doing any studies regarding people who test positive for COVID after receiving the COVID-19 Vaccine. Not sure if Pfizer would be interested in doing antibody studies. Declined obtained COVID-19 Vaccine through work Clarified caller's days worth of symptoms as: Headache the same evening as vaccination. Body Aches: began overnight on 18Dec2020. Fatigue that lasted all week, began overnight on 18Dec2020. Cold sweats: Lasted two days and began overnight on 18Dec2020. Nausea: began on 21Dec2020, not sure if it was related to COVID-19 Vaccine or not. The reporter considered the events weren't serious, but felt like she was having an immunological response. Diagnosed with COVID Seriousness: As of now, not serious. Is having a recurrence of all of those same symptoms as the COVID-19 Vaccine and then some. Lot number provided from patient card. Stated she was unable read it accurately. would take picture in case Pfizer wanted it. Stated lot number was either EK5730, ER5730, or EX5730. A sample of the product was not available to be returned. Vaccination facility type was Hospital, not administered at military site. No additional vaccines administered on same date of Pfizer suspect. No adverse events required a visit to. No prior vaccinations received within 4 weeks. The outcome of the event "Cold sweat" was recovered on 20Dec2020. The outcome of the other events was unknown. The reported considered the events Headache, Body aches, fatigue, Cold sweat, Nausea were related to the suspect drugs. Information on the lot/batch number has been requested.; Sender's Comments: The reported COVID test positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
51 2021-01-05 flushing Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse Al... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021   Date: 1/6/2021   Subjective Patient is a 51 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness, flushing and HA. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   Hx: pt has history of breast CA and is on oral chemotherapy.     ALLERGY REVIEW OF SYSTEMS: All other systems negative       Objective   Vitals Vitals:   01/06/21 1415 01/06/21 1427 01/06/21 1443 BP: (!) 168/89 (!) 154/94 (!) 154/84 Pulse: 87 85 72 SpO2: 99% 98% 99%   Physical Exam Vitals signs and nursing note reviewed. Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.       Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.   Pt was given Food and water and started to feel better. For her headache she was given Tylenol 1000 mg orally. Pt left clinic at 2:45 pm.       Electronically Signed 1/6/2021 2:44 PM    
51 2021-01-05 tingling 15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but ... Read more
15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but then felt presyncopal. Sat down, drank water and ate a cookie. The feeling did not subside. After about another 20 minutes, felt tingly all over. After about 5 minutes of that, the tip of my tongue started too tingle. I alerted the staff and they checked my pulse (nl in the low 60s) and my BP (normal SBP 112). They gave me liquid Benadryl 25 mg and the tingling immediately stopped but I still felt lightheaded. They transported me to the ED. I was given 1 L of fluid and monitored and rested for about an hour, then I felt fine. No other tests or meds given
51 2021-01-05 speech disorder, numbness Patient complained of episodes of numbness on left side of face along with difficulty speaking lasti... Read more
Patient complained of episodes of numbness on left side of face along with difficulty speaking lasting up to 5 minutes. She has had 4 episodes since vaccination, last one was 1 week ago
51 2021-01-06 flushing Dizziness Narrative: Pt received the vaccine at 9:28am. Approx 15-24 mins after the administration ... Read more
Dizziness Narrative: Pt received the vaccine at 9:28am. Approx 15-24 mins after the administration began to feel lightheaded, sweaty and flushed. Pt states this is not uncommon for her, has history of this after shots and occurs spontaneously throughout the day. Pt's face was flushed but did not develop any tongue or lip swelling, denied sob or respiratory difficulty. On exam op clear, no swelling to lips, tongue, no stridor, lungs cta bil, no wheezing, cor rrr s1s2 no m/g/r, abd soft nontender, ext no c/c/e, left upper ext injection site without redness or swelling. Vital signs were T 97.5, bp 154/97 p 95, o2 sat 97%, bp 146/80, p98, 100% 148/05 p 102 99%, 163/92 p83 o2 99%. Pt was observed for the next approx. 15-20 mins, given water and improved. Walked around the clinic with the pt who felt comfortable to be discharged. She was instructed to monitor her symptoms, follow up with her primary md regarding pretreatment prior to second vaccine and to go straight to the ED if her symptoms progress or worsen. Pt understood and agreed with instructions. Pt works in the facility and will be around medical personnel until 8pm.
51 2021-01-06 migraine, muscle spasms Headache, Fever, fatigue, muscle spasms 12/29 received the vaccine. Woke up tired on 12/30. That nig... Read more
Headache, Fever, fatigue, muscle spasms 12/29 received the vaccine. Woke up tired on 12/30. That night woke up with muscle spasms all over her body and took her temp which was 101. The muscle spasms stopped at 0300 on 12/31. After that she developed a migraine. Headache last 22 hours and then just went away. She was tired the following day 1/1. All symptoms resolved on 1/2. She received the first vaccine in the ED and is scheduled to receive the second one in the ED as well. She has h/o anaphylaxis to food and bugs.
51 2021-01-06 muscle twitching 36 hours after receiving the vaccine I was awakened at 4:00 AM 12/20/20 by muscle fasciculations- mo... Read more
36 hours after receiving the vaccine I was awakened at 4:00 AM 12/20/20 by muscle fasciculations- mostly in my legs. It was very bothersome and caused difficulty sleeping for a few days. The second week after the vaccine it seemed to get better. I?m due for my second dose tomorrow and the fasciculations are back as of a few days ago, around 1/4/21. I?m wondering if I should get the second dose.
51 2021-01-07 weakness, muscle twitching Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches ... Read more
Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches and weakness that evening, took tylenol with relief. 1/8/21 patient woke up in the middle of the night with fever, blister on the inside of her lip, and her right cheek twitching. 1/8/21 patient went to PCP to be checked out. Discovered redness and bruising at the injection site. Patient has had relief with tylenol and zyrtec.
51 2021-01-07 pain in extremity I started few hours later started feeling thought it was stress. The next morning around 9am high mo... Read more
I started few hours later started feeling thought it was stress. The next morning around 9am high moderate pain left leg jaw, chest hurt, sudden panic attack and I had to calm down for minutes. I informed my coworker I was having a reaction and then it stopped. Then I scheduled an appt with my PCP had lab work, EKG results was normal. On 12/24 still exp high mild left jaw pain, heart racing and chest pain .I was scheduled stress test on 12/30 was normal.
51 2021-01-07 pain in extremity Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache,... Read more
Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache, stiff/achy neck and shoulders and some chills. Upon waking on 1/8/21 my left armpit is sore and swollen.
51 2021-01-08 burning sensation lip swelling, facial hives/erythema, burning
51 2021-01-08 flushing After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. ... Read more
After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. I sat and monitored what was happening and then notified the staff that it was not improving. I was directed to go to the ER for further evaluation and went. They monitored me and it resolved after about 3 hours and went home. No other issues occurred.
51 2021-01-08 tingling Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "differ... Read more
Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "different" and spotty non-confluent erythema and pruritis over affected arm, upper chest, posterior neck. She reported feeling faint and began to have mild hyperventilation. Vital signs remained stable and WNL, lungs were clear with good air movement and there was no mucosal involvement. Pt was treated with PO bendryl. Over the course of 45 minutes her rash faded and her sense of pruritis also lessened. She was able to return to work with no further symptoms
51 2021-01-09 burning sensation, pain in extremity, tingling 2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tin... Read more
2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6
51 2021-01-09 facial pain Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left b... Read more
Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left back of shoulder, neck, face pain , moderate severe headache. SOB.
51 2021-01-09 numbness, migraine, tingling 1. Migraine headache that will not go away with Ibuprofen. 2. Body aches 3. Fatigue 4. Numbness and... Read more
1. Migraine headache that will not go away with Ibuprofen. 2. Body aches 3. Fatigue 4. Numbness and tingling in the arm the vaccine was administered in
51 2021-01-09 migraine Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm... Read more
Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm that received vaccine
51 2021-01-09 pain in extremity Received vaccine on 1/5/2021 and is complaining of swollen and stiff left arm and inability to move ... Read more
Received vaccine on 1/5/2021 and is complaining of swollen and stiff left arm and inability to move the left arm. States pain is 10 on a 10-point pain scale . Has been on Advil and Tylenol with no relief
51 2021-01-09 tingling, burning sensation, pain in extremity 1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever ... Read more
1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever and chills temp at that time 100 degrees , : fever 100 to 101 degrees on day 1 , 2 , 3 , 100 degrees on day 4 , day 5 , myalgia , body aches and headaches daily week 1 and fatigue week 2 was bed bound for 2 days and then could not work for 3 days after that 2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6
51 2021-01-09 tingling, numbness Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to h... Read more
Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to her nose and other ear/jaw area. Then she experienced tongue heaviness and tingling. She was transported to the ED for further evaluation.
51 2021-01-10 feeling hot, flushing NauseaVomiting chills, feels hot-flushed, eyes are glossy Narrative: Has not had to seek any medica... Read more
NauseaVomiting chills, feels hot-flushed, eyes are glossy Narrative: Has not had to seek any medical attention, leaving work to rest and hydrate. Feels hot and is flushed but has not taken her temperature.
51 2021-01-10 feeling hot 0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920... Read more
0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920 - symptoms improving
51 2021-01-10 pain in extremity Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Ac... Read more
Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Achy all over Left arm down to fingers and up the arm and across the chest to swollen arm under arm pit is in pain
51 2021-01-10 pain in extremity Vaccine recipient reported that in the afternoon after receiving their vaccine, they experience seve... Read more
Vaccine recipient reported that in the afternoon after receiving their vaccine, they experience severe headache and nausea. They also developed chills, body ache, and arm pain at night. On a follow up call on 1/11/2021, they reported that their symptoms resolved on 1/8/2021.
51 2021-01-11 breast pain, pain in extremity 10 hours later after received vaccine developed Left arm pain . During the night wake up due to seve... Read more
10 hours later after received vaccine developed Left arm pain . During the night wake up due to severe left axillary pain irradiated to left scapula, left breast, also has adenopathy, bone ache and fatigue. Taken acetaminophen
51 2021-01-11 discomfort erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round ar... Read more
erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round areas on the left side of neck; feel more inflamed; burning feeling to the touch; Is getting slightly painful; Discomfort; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 05:30 at a single dose for COVID-19 immunization. Medical history included atopic dermatitis. Patient previously took DUPIXENT, last dose was 18Dec2020 (due to a lack of knowledge about DUPIXENT) and the COVID vaccine, patient have not taken next due dose of DUPIXANT on 01Jan2021). Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 31Dec2020 02:00 (reported as day 4 after the injection), patient developed 2 swollen erythematous maculopapular round areas on the left side of neck that were sore and slightly have a burning sensation (not pins/needle) to the touch also described as 2 very large erythematous swollen thick raised sores with vesicles on the left side of neck. Patient showed photos to internist a couple days later when they did not go away. As of this reported, it was now day 10 and they are not bigger but they feel more inflamed and have more of a burning feeling to the touch. The small vesicle on each sore had disappeared. Patient stated she had a history of atopic dermatitis but looked and felt nothing like it. Initially had little vesicular areas in the center but the vesicles aren't there today. Discomfort remains. No associated fever or headache. Patient had read of zoster developing with COVID-19 infection, but not associated with the actual vaccine. She was asking if this might be a weird varicella zoster reaction to the vaccine and any data about this. This did not seem to be going away and was getting slightly painful (though so far tolerable) though does not seem to be spreading at this point. Outcome of the events was not recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information on the lot/batch number has been requested.
51 2021-01-11 feeling hot, pain in extremity Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness ... Read more
Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness all over; Neck is also really sore; head hurt/headache was in the occipital area; mild pain at the injection site; Her whole arm is swollen and sore/Sore upper arm/arm achy; Her whole arm is swollen and sore/Sore upper arm; whole arm felt warm/warm to the touch; This is a spontaneous report from a contactable Nurse(patient). A 51-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization(reported as for work). She worked in the hospital. She just got it at work. She didn't have a prescribing doctor. Her first dose was 3 weeks before today. Her first vaccine was a Pfizer vaccine with lot:13551. She got the 2nd dose 20 days later. She got the second dose on 05Jan2021. Medical history and concomitant medications reported as none. Also reported she did have other medical conditions, but she got the go ahead to get the vaccine from her rheumatologist. Patient received her second dose of vaccine 05Jan2021 and was experiencing fever, chills, achiness during the night last night on 06Jan2021. She was asking if she was experiencing adverse events or Sars-COV-2 symptoms. At first, she had mild pain at the injection site, but then in the middle of the night, her whole upper arm became sore and swollen. Not just at the injection site. Onset date of sore upper arm was 05Jan2021. She developed rigors/chills. She had achiness all over. She checked her temperature a half an hour to 45 min ago, and it was 99.9-100.2. She usually runs 96-97. It was around 3-4 am that she felt chilled, but not feverish. She was just chilled/ had rigors. It was a couple hours later at 7 am that she felt feverish. They were not high readings. In the past 10 minutes, her head had started to hurt. Her neck was also really sore. Her headache was in the occipital area. It had only been 10 mins that this had came on, and it was about the same. It really hurt. Onset date of headache/ neck pain was 06Jan2021. Her whole arm was swollen and sore. It was warm to the touch. Her whole arm felt warm and achy. She had used an ice pack, and it did help some. She was assuming this was just an expected immune response. She just didn't want to put anyone at risk. She was always very careful. She mostly worked from home, but she was in the office yesterday with two masks and a face shield. She also used a lot of spray and hand sanitizer. The outcome of events fever, achiness, "Her whole arm is swollen and sore/Sore upper arm/arm achy" and headache, neck pain was not recovered, of chills was recovered in Jan2021, of other events was unknown. Sore upper arm was reported as worsened.
51 2021-01-11 feeling hot Warm feeling in chest Better after waiting and drinking water
51 2021-01-11 hot flush Hot flash, lasted whole day; Itching all over whole body/Itching in hands and feet all the time; Thi... Read more
Hot flash, lasted whole day; Itching all over whole body/Itching in hands and feet all the time; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Vaccine location was arm. None medical history. The patient's concomitant medications were not reported. Patient stated she had the COVID vaccine on Dec18th, her first one and she was fine, no issues and she would say the following Wednesday (23Dec2020), she started getting like a hot flash, it lasted whole day and then her feet started itching. And now, she have got itching all over her whole body and especially in her hands and her feet all the time. She went to her family doctor. She have not had this issue before and she don't have any known allergies. And she went to family doctor and he prescribed some antihistamines and of course they are still bothering patient. Besides itching, she was not having any other complication. Patient went to family doctor last week and he put her on a prescription of antihistamine trying to help. It is not helping, Benadryl helped her. When probed for the name of the product, patient stated she think the name of it is Lyrica. The events were persisting. She had better times but then it was other times when it is worse. When asked the causality, the patient stated she think so. She has never had a reaction like this and it has been going on everyday ever since. The only thing that worries is she was due to get her second one on the 8th which is this Friday and she have heard people rumors saying that when get second vaccine, whatever symptoms she was having are even worse. Patient don't know is it true. And of course everyone is saying like, normally they say - any reactions you get like the first 24-48 hours but her didn't happen until almost halfway till first week.
51 2021-01-11 numbness anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry... Read more
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-01-11 numbness "EOHD Note 12/29 EE states she recieved the COVID19 vaccine (first dose) 12/28 at 7 pm at the Metro ... Read more
"EOHD Note 12/29 EE states she recieved the COVID19 vaccine (first dose) 12/28 at 7 pm at the Metro EOHD location. She stayed 15 minutes for observation and was feeling fine, however 30 minutes after vaccine administration started feeling her left upper lip was swollen and tip of her tongue felt thick. When she looked in the mirror her lip and tongue appeared normal, but she had the sensation they were swollen. She then took 50 mg of PO Benadryl and about 4 hours later felt swelling had resolved. Today, feels normal. Pt denies hx of allergies but her mother has a hx of anaphylaxis with IV contrast. EE denies throat tightness, SOB, wheezing. Numbness on left leg. Advised EE to go to ER if she experiences throat tightness and itchyness, SOB, or wheezing. Advised pt that she should consult her PCP to decide whether or not the benefits of recieving the second dose of the vaccine outweigh the risks and if she should pre-medicate with benadryl for the second dose if she choses to recieve it. "
51 2021-01-11 migraine Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; S... Read more
Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscularly on 28Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. Medical history included migraine from an unknown date. Concomitant medication included erenumab aooe (AIMOVIG), estradiol, diphenhydramine hydrochloride (BENADRYL), trazodone hydrochloride (TRAZODON). No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site on 28Dec2020 15:00. Patient received Antibiotics, steroids epi as treatment for the adverse events. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event migraine was recovered in Jan2021, other events was recovered on an unknown date. The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Vaccination site cellulitis, shortness of breath, stridor and migraine, due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-01-11 pain in extremity body aches (just legs ache); very mild sore arm; fatigue; This is a spontaneous report from contacta... Read more
body aches (just legs ache); very mild sore arm; fatigue; This is a spontaneous report from contactable nurse (patient) from a Pfizer-sponsored program. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 28Dec2020 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included possible exposure to COVID-19 patient on 22Dec2020 to 23Dec2020 (patient's patient tested positive on 24Dec2020 and saw the patient on 22Dec2020 and 23Dec2020). The patient's concomitant medications were not reported. The patient experienced fatigue on 28Dec2020, very mild sore arm on 29Dec2020, and body aches (just legs ache) on 02Jan2020. The clinical course was reported as: The patient felt fatigue on the day of vaccination and very mild sore arm the next day. The patient experienced body ache (just legs) on 02Jan2021, but it was less on 03Jan2021. The clinical outcome of fatigue and very mild sore arm was unknown and of body aches (just legs ache) was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
51 2021-01-11 pain in extremity Vaccine 2 only: severe arm pain began 2 hours after shot. Within 8 hours I had severe pain all over... Read more
Vaccine 2 only: severe arm pain began 2 hours after shot. Within 8 hours I had severe pain all over my body and fever 103F. Still have severe headache 36 hours late and fever 100F.
51 2021-01-11 pain in extremity COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/... Read more
COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; arm pain; she felt like crap the night; chills; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899, expiration date Mar2021), intramuscular on left arm, on 18Dec2020 at 0.3 mL, a single dose for vaccination. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and she tested positive with Covid. She received the Pfizer Covid vaccine on 18Dec2020. She was exposed to the virus through close personal contact right around this same time-frame and did develop the virus herself. She wanted to know if there were any recommendations regarding her needing to get the second dose in series. She stated that her husband, who was not vaccinated, had the virus and developed more serious symptoms than she did. She is concerned about worsening side effects with the second dose and stated that she felt like crap the night after her first dose with chills and arm pain. The patient tested positive for COVID-19 on 26Dec2020. Specific test name was unknown, but she knows it was not a rapid test. She is scheduled to get the second dose of the Pfizer COVID-19 Vaccine on 08Jan2021. She called to ask if she should or should not get the second dose relative to the COVID-19 diagnosis. She has not been able to find the information she is asking about. The outcome of the event of Covid-19 was recovering while other events was unknown. The Covid-19 was assessed as unrelated to the suspect drug.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment. COVID-19 antigen test positive.
51 2021-01-11 tingling Dizziness tingling and subjective throat swelling Narrative: only taken to ER on account of employe... Read more
Dizziness tingling and subjective throat swelling Narrative: only taken to ER on account of employee health closed
51 2021-01-11 tremor ANXIOUS, WARM TO TOUCH, HEAVY EYES AND SHAKES Narrative: VITALS STABLE @1025 BP134/76 HR 88 02 96% ... Read more
ANXIOUS, WARM TO TOUCH, HEAVY EYES AND SHAKES Narrative: VITALS STABLE @1025 BP134/76 HR 88 02 96% @1045 BP SYMPTOMS MONITORED LONGER, CALLED FOR TRANSPORT TO ED PER PROTOCOL. PT WAS ALERT AND CONCIOUS
51 2021-01-12 burning sensation Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 d... Read more
Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 days. Treated with steroid injection and Benadryl. Treatment started January 4, 2021.
51 2021-01-12 discomfort, flushing Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to ... Read more
Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to left neck and under arm, chest pressure, vomiting, and loose stools
51 2021-01-12 feeling jittery Jitters and increased anxiety and feeling of being overwhelmed. Prescribed Prozac 10 mg daily at th... Read more
Jitters and increased anxiety and feeling of being overwhelmed. Prescribed Prozac 10 mg daily at this office visit.
51 2021-01-12 flushing gut wrenching nausea; stomach ache; flushed; dizzy; Headache; This is a spontaneous report from a co... Read more
gut wrenching nausea; stomach ache; flushed; dizzy; Headache; This is a spontaneous report from a contactable other HCP(patient). A 51 years old female patient received first dose BNT162B2(lot number EL0140), via an unspecified route of administration on 29Dec2020 08:00 at the 51 years old at Arm Left at single dose for COVID-19 immunization. The patient medical history was none. The concomitant medications were none. The patient had her first dose on 29Dec2020, she had no fever or chills and she got it at 8AM, and she woke up on 30Dec2020, and for the last 9 days when she wakes up, she was gut wrenchingly nauseated. It lasted like up to sometimes until noon, she still had a little nausea now, and it is almost noon there, and this comes along with being so nauseated. She was having a pretty moderate stomach ache on 30Dec2020, especially after eating, then she was really felt flushed and dizzy on 30Dec2020, but she thought because the nausea was so bad. She had a headache on 30Dec2020 and lasted for 5 days. She was not sick prior to the COVID vaccine. The outcome of the event Headache was recovered on 04Jan2021, the other events was not recovered.
51 2021-01-12 flushing dizziness; flushing; HA (Headache); This is a spontaneous report from a non-contactable healthcare p... Read more
dizziness; flushing; HA (Headache); This is a spontaneous report from a non-contactable healthcare professional. A 51-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, then the second dose (lot number: EK9231, expiry date not reported) via intramuscular route of administration the left deltoid muscle on 06Jan202, both at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience dizziness, flushing and HA (headache). She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, and lightheadedness. No therapy/ treatment was given. Events were non-serious. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
51 2021-01-12 flushing Pt received COVID vaccine on 12/27/2020 at 1421 and tolerated well. By 1700 that same day, pt felt f... Read more
Pt received COVID vaccine on 12/27/2020 at 1421 and tolerated well. By 1700 that same day, pt felt flushed in her hands and face. She felt a little short of breath. She started to get fluid-filled blisters on bilateral palms. This is a milder form of the reaction pt has to flu vaccines (she was advised by PCP not to receive flu vaccines because of the blistering). Pt took diphenhyramine 25 mg PO x 1 and the fluid-filled blisters resolved within a few hours. 12/28 around 0330, pt awoke and felt like her right carotid was "pulsating." Pt drank water, did not go back to sleep. "Pulsating" resoved within an hour. No other symptoms develped. In the morning, pt called employee health RN who instructed her to contact PCP and report the reaction. Pt called PCP who advised pt not to get second dose of vaccine due to her reaction to COVID and the flu vaccines.
51 2021-01-12 pain in extremity, tremor Left arm pain, armpit pain, body aches, shaking chills, nausea, extreme tiredness
51 2021-01-12 pain in extremity Rec'd vaccine on 1/9/21. On 1/11/21 she developed swelling to both hands to the point it caused pain... Read more
Rec'd vaccine on 1/9/21. On 1/11/21 she developed swelling to both hands to the point it caused pain.
51 2021-01-12 pain in extremity The day after receiving the vaccine I woke up with slight soreness of the arm. At work at 10:00am I ... Read more
The day after receiving the vaccine I woke up with slight soreness of the arm. At work at 10:00am I began to get fatigued chills overall body aches but was afebrile. I also had nasal congestion and sneezing for 4 hrs. that resolved. At 12 noon I felt progressively worse and had to leave work. I got home and my temp was 100.2 and took more Ibuprofen at 1 PM. At 2PM the body aches and chills were pretty severe- my temp rose to 103.2. I took more Ibuprofen and alternated with TYLENOL and it returned to normal at 10 PM. I notified my Drs office and had a telemedicine visit with Dr at 4PM who thought it was a normal immune response but suggested getting a COVID Test in the meantime before returning to work. I woke up this morning afebrile with no issues notified employee health got a referral and had my COVID test completed at 09:30am. The urgent care MD strongly urged me to report to VAERS, not just CDC as I had yesterday. My COVID tests are still pending.
51 2021-01-12 pain in extremity No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, min... Read more
No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, minimal pain at left deltoid injection site. Used Tylenol for ineffective relief of discomfort. Next day, 1/11/21, noted swelling and pain along left collarbone area on chest/neck area. Called to speak with Dr. Told that I had left supraclavicular lymph node swelling causing discomfort, and still had swelling of left axillary lymph node causing discomfort. Also noted minimal left groin lymph node enlargement with no pain. Told to monitor symptoms and continue to use Tylenol or Advil as needed. Recommended that I call back if symptoms worsen, change or have additional symptoms.
51 2021-01-12 pain in extremity Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies;... Read more
Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies; Body was not feeling well, she felt like she was getting the flu; Body was not feeling well, she felt like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E10142), via an unspecified route of administration on left upper arm at 10:40 AM on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hip replacement from Aug2020 (Right hip replaced in Aug2020, she was a runner and this is due to wear and tear), allergies, family history included diabetes and high blood pressure. Concomitant medication included cetirizine hydrochloride (ZYRTEC). Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. The patient previously received flu vaccine for immunization. The patient was having symptoms, nothing life threatening but she wanted to report them. Weight: 150lb-152lb. She was in healthcare but not a healthcare provider, she work in a outpatient clinic. Her first shot was on 05Jan2021. That day she experienced nausea and was light headed in the evening on 05Jan2021. She thought it was her allergies. She was really tired and went to bed really early that night. She got chills last night on 06Jan2021 and her body was not feeling well, she felt like she was getting the flu. Her joints were sore and her head started to hurt. The nausea, light headedness and tired feeling got worse last and she went to bed even earlier that night. She took her temperature this morning, she didn't take it last night as she knew she would get some symptoms from the shot, and she had no fever. Sometimes got light symptoms from the flu vaccine that she got every year, she had no product name, NDC, Lot, or Expiry for that product. When she woke up her head was still killing her but felt sickly. She went to work, she just thought she would power through it but she felt like she could go home and go right to sleep. The day of the shot she took a One a Day Women for 50 and over and a Zyrtec. Yesterday morning she took the Zyrtec but not the vitamin and she didn't take either this morning due to her stomach. She was told she should take Tylenol so maybe she would take that today. It was also noted that her left upper arm was sore where she got the shot on 05Jan2021, it had gotten better today. The outcome of events feeling unwell and flu-like illness was unknown. The outcome of event pain in arm was recovering, the outcome of rest events was not recovered.
51 2021-01-12 tingling Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ea... Read more
Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ear and arm felt funny
51 2021-01-12 tingling Employee received Dose 1 of COVID19 vaccine. Approx 30mins later employee complained of tingling to ... Read more
Employee received Dose 1 of COVID19 vaccine. Approx 30mins later employee complained of tingling to right toe, right jaw lock, and headache on right side 4/10 pain.
51 2021-01-13 discomfort, pain in extremity received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breath... Read more
received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breathing something similar to allergy season belreathing, and a slight headache on my rr temple. This was nothing that stopped me or slowed me down that day. At approx 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At approx 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I have notice much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopefully, all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night. I have a history of whooping cough. And gastric bypass.
51 2021-01-13 feeling cold, weakness Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and f... Read more
Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and flu like symptoms. Next day the symptoms progressively got worse to include chills, body aches and joint pain and headaches, sluggish and no energy. Had to leave work early due to feeling tired, no energy and went home slept rest of day throughout night, unable to eat. Symptoms stayed the same throughout a Friday Jan 8th still with chills, aches, joint pain and headaches, nausea started to subside finally ate some soup and drank liquids , again was sluggish no energy still and went to bed early. Saturday January 9ththe headaches subsided and I started to feel better... Saturday January 9ththe headaches subsided and I started to feel better, but still did not feel like myself, all over less aches and pains but still not feeling well, still tired and Sunday the same but was able to have an appetite. Monday went into work still not 100% but was able to function. Started feeling like myself by wednesday 1/13.
51 2021-01-13 feeling hot, flushing Felt hot and flushed
51 2021-01-13 numbness, speech disorder, tingling Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30a... Read more
Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision. I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand. I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
51 2021-01-13 pain in extremity, tenderness Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , g... Read more
Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , given morphine, Valium,zofran, dexamethasone and norco and discharge home. No relief with med. lower feet noted trace of swelling, jaw pain and epigastric discomfort. Leg pain subside after 3 days but with muscular pain esp the upper arms. Extreme fatigue and mild tenderness on the back of head. It?s been 3 weeks now and I have the fatigue, epigastric discomfort, loss 10 lbs of wt. muscle easily get sore.
51 2021-01-13 pain in extremity Brief (less than 2 minutes) itching in throat. Sore left arm for 2 days. On day 2, inability to lif... Read more
Brief (less than 2 minutes) itching in throat. Sore left arm for 2 days. On day 2, inability to lift arm for about 1 hour, improved after ibuprofen. Significant fatigue for 2 days. By day 3, all symptoms resolved.
51 2021-01-13 tingling, hot flush, numbness Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no se... Read more
Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no sensation of hot/cold.
51 2021-01-14 weakness Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, ... Read more
Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, body aches, skin sensitivity, headache, chest tightness and burning on inspiration, runny nose, unproductive cough, just felt horrible with all of this for two days fever ran between 99.7 and 100.6. Symptoms began to resolve and no fever by day three. Every day after continued to improve but joint pain, weakness with a general malaise through Thursday. It is now the following Friday and I am still experiencing fatigue and just a general feeling of not being quite 100%.
51 2021-01-14 weakness 2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen... Read more
2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen as a rock, hot to touch and sore. 1/15/21 injection site redness, swollen as a rock, hot to touch and sore; skin temp taken 100.0 at injection site, localized in area, not feeling well, weakness, neck stiffness, headaches Midrin taken for intense headache. Pt has been resting all week, off work returned today no fever. 1st dose: no ae to report
51 2021-01-14 breast pain On the 1/11/2021 I noted a discoloration to the outer left axilla area- resembling bruising, and a r... Read more
On the 1/11/2021 I noted a discoloration to the outer left axilla area- resembling bruising, and a round, flat rash like area. I have swelling to my left axilla, with 3 points of pain with palpation within it. I also have tenderness in my left breast closest to my axilla.
51 2021-01-14 feeling hot body itching, eye itching and irritation, body warmth, chest tightness, bradycardia
51 2021-01-14 feeling hot body itching, eye itching and irritation, body warm, chest tightness, bradycardia
51 2021-01-14 numbness Approximately 30 minutes after injection I developed a sunburn type reaction (similar to red man syn... Read more
Approximately 30 minutes after injection I developed a sunburn type reaction (similar to red man syndrome), it lasted 5 hours and dissipated after. Also developed right ear pain and jaw pain, which is still present. At the same time my right side of my face was numb which lasted a couple days.
51 2021-01-14 seizure Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic re... Read more
Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic reaction.,
51 2021-01-15 night sweats 1st day- Body aches, headache, mild fever 100.1, night sweating when sleep 2nd - Body aches, headac... Read more
1st day- Body aches, headache, mild fever 100.1, night sweating when sleep 2nd - Body aches, headache, mild fever 99.9 3rd day - body aches only
51 2021-01-15 pain in extremity, muscle spasms Myalgia pain sided pain down arm/leg. Leg cramp down the right side, spasms down the leg, hurt when ... Read more
Myalgia pain sided pain down arm/leg. Leg cramp down the right side, spasms down the leg, hurt when she walked, while bathing, was unable to put any pressure on that leg. Similar pain down the right arm. Took Ibuprofen OTC. Today side effects are resolving.
51 2021-01-17 burning sensation Mucus membranes burning/inflamed sensation. Vaginal area swollen, red, inflamed. Lips and tongue ti... Read more
Mucus membranes burning/inflamed sensation. Vaginal area swollen, red, inflamed. Lips and tongue tingling. Started having symptoms a couple of hours after 2 dose of vaccine. Feels like nerves are burning in these areas. Intense headache 24 hrs after shot. Took Tylenol 500 mg with no relief. Took naproxen 550 mg Tuesday night around 10 pm. Resolved headache but not burning sensation around mucus membranes. Got progressively worse. Saw MD on Friday who did pelvic exam. Confirmed vaginitis. Prescribed Medrol dosepak, refresh vaginal lubricant and topical desitin. Currently on day 4 on Medrol dospak with some relief. Burning sensation now comes and goes and is not constant. Again, the burning sensation feels like the nerves in the areas of mucus membranes are inflamed.
51 2021-01-17 hot flush, pain in extremity Arm started hurting within hours of shot and was mainly gone in 2 days. The next morning I was so le... Read more
Arm started hurting within hours of shot and was mainly gone in 2 days. The next morning I was so lethargic and exhausted I could barely get out of bed. Late afternoon I started feeling better. Also had headaches, hot/cold flashes , was very achy and a lot of sinus pressure. By Monday morning minimal arm pain still lingered
51 2021-01-17 migraine BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe ... Read more
BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe nausea (but could be from headache).; Possible migraine; Mild photophobia; Mild photophobia; This is a spontaneous report from a contactable Physician who reported for herself. A 51-year-old female patient received her second single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EL3249) at left arm at 17:30 06Jan2021 for Covid-19 immunization in a hospital. She had her first injection at 07:15 PM 18Dec2020 and experienced mild photophobia within 5-10 min. The patient had a medical histroy of allergic rhinitis and was allergic to cashews. Concomitant medications included fexofenadine, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccines within 4 weeks prior to her first COVID vaccine. Within 5-10 minutes of 2nd injection, the patient had mild photophobia (also after 1st injection but patient did not recognize the symptom at that time). About 20 hours after 2nd injection, the patient developed severe sharp headache behind left eye, severe nausea (but could be from headache/ possible migraine). The patient stated that she had no prior history of migraines or frequent headaches. Three days after 2nd dose, the patient's lingering intermittent mild left-sided headache persisted. The patient self-administered OTC oral analgesics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events headache, nausea, migraine, photophobia at the time of last observation was resolving. The patient considered that the events were non-serious.
51 2021-01-17 pain in extremity Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fati... Read more
Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fatigue, bilateral orbital pain. No visual problems. Took Tylenol every 4 hrs and fever (101. 5)returns in 1-2 hrs. Pulse ox remained normal, 98%, but pulse was 99/min. Usually my resting pulse ox is 55/minutes. Was unable to go to work and see patients. Had these symptoms for 48 hrs even though stayed in bed, took Tylenol around the clock and drank plenty of fluids (2-3 liters of water in addition to natural orange and apple juices). Never lost appetite either, do eating my vegetables and fish diet. Ice cream help between Tylenol?s. Completely resolved after 72 hrs. Now still have LEFT injection site tender deltoid and left axillary tender nodes, improving as well. All along breathing fine, no cough or congestion or sore throat. No anosmia or dysgeusia. This was after my second Pfizer dose. After the First dose only had tenderness on the RIGHT deltoid muscle injection site and tender axillary node, resolved by now.
51 2021-01-18 burning sensation, pain in extremity Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; ... Read more
Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; kidneys were hurting; body aches; tested positive; tested positive; The arm wasn't swollen it was just burning.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. At first, she thought she was having a reaction, but then she started feeling sick so she got tested. She was positive so she wasn't having a reaction. She was scared from the pain of COVID. She experienced sickness. Her stomach was still weirded out. She did experience arm pain from the vaccine. Her doctor told her it was fine that it needed to air out. She left the bandage on too long. She didn't have a prescribing doctor. She received the vaccine on the 29Dec2020. She tested positive 02Jan2020. The arm wasn't swollen it was just burning. She was sick to her stomach when she got the stomach. The sick to the stomach lasted maybe two days, but then she got COVID. The burning was around the arm. It wasn't that bad. It lasted for a day. It started the day she got the shot (on the 29Dec2020). On 07Jan2021, she went to the hospital because her kidneys were hurting. The doctor said her kidneys were good. They did labs which were good. She was still going through body aches. She was told she was currently in the worst part of the virus. She still had a sour stomach going on from the virus as well. The outcome of the body aches and sour stomach was not recovered, for other events was unknown.
51 2021-01-18 difficulty speaking Patient received Covid vaccine ?around 3:45?. Patient?s initial complaint was feeling ?alittle bit i... Read more
Patient received Covid vaccine ?around 3:45?. Patient?s initial complaint was feeling ?alittle bit itchy? and her ?nose was closing up?. Vitals taken at 3:48- 129/75 BP, 98 HR, 98% O2. Continuing complaint of ?itching?. 1 mL of Benadryl (Lot #080010, Exp 08/22) given at 3:52. Vitals taken again at 3:54- 150/84 BP, 92 HR, 97% O2. Patient sipped water and speaking with responding nurses at 3:55. At 4:00, reported ?throat itching? and had hoarseness, coughing, and congestion. 4:01, 0.3 mg Epi given via autoinjector (Lot #0GM147, Exp 11/21). 4:06 patient reported her tongue was less ?itchy? and decreased congestion. 4:14 vitals were 123/72 BP, 106 HR, 98% O2 & patient reported no improvement of symptoms. 4:15, Dr. was called at which time recommended to call EMS. 4:16, RN called EMS. 4:18 patient reports ?someone is pushing on my throat?. 4:20 a 0.3 mg Epi given via autoinjector (Lot #0GM147, Exp 11/21). 4:22 vitals were 126/81 BP, 107 HR, 96% O2. 4:26 EMS arrived at clinic and left via stretcher. EMS provided with medications given to patient.
51 2021-01-18 facial paralysis 9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 we... Read more
9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.
51 2021-01-18 migraine Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sne... Read more
Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sneezing; Body aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 14:50 at single dose at right arm for covid-19 immunization. No additional vaccines administered on the same date. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing migraine. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) for migraine, patient had been alternating this with paracetamol (TYLENOL) while she has been recovering. She clarified the symptoms she experienced as the same day she got the vaccine that evening she had a headache on 29Dec2020. It eventually became a migraine and she left work early. On 30Dec2020 she had body aches, little nausea, and chills. On 31Dec2020, she had more chills, a runny nose, she felt like she was coming down with a cold. She was sneezing, had more chills, more body aches. On 01Jan2021 she felt like she noticed she had phlegm in her throat, but she did not have any pain. The phlegm was causing her to cough more. She had a runny nose the next morning as well. She did the rapid test for COVID on 02Jan2021 evening, and it was positive. She had a headache almost every day. The body aches had pretty much worn off. Runny nose and sneezing resolved in Jan2021. Phlegm in throat confirmed with no pain. This also resolved, as well as coughing. Outcome of event tested positive for COVID was unknown, outcome of event headache was not recovered. outcome of event nausea was recovered on 07Jan2021, event chills was recovered on 08Jan2021, outcome of other events was recovered on unspecified date in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Information of lot/batch number has been requested.
51 2021-01-18 pain in extremity Bleeding at left arm injection site; Flu like symptoms; feeling unwell; fatigue; mild headache; inje... Read more
Bleeding at left arm injection site; Flu like symptoms; feeling unwell; fatigue; mild headache; injection site pain; injection site pain, increased soreness in 24 hrs; This is a spontaneous report from a contactable nurse. A 51-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular into the left arm on 17Dec2020 at 02:45 PM at single dose for COVID-19 immunization. Medical history included Childhood asthma, NIDDM and known allergies to Latex. Concomitant drugs included Metformin, Glyburide, Lisinopril, Jardiance, Januvia, Atorvastatin, Proventil, Advair, Tylenol, MVI, D3, Diosmin, Niacin, Flonase, Vit C. On 17Dec2020 after first dose administered, at 03:00 PM, the patient experienced injection site pain, increased soreness in 24 hrs, bleeding at left arm injection site; flu like symptoms at the 12th hour of vaccination despite of tylenol and ibuprofen alternate medication. Generalized feeling unwell, fatigue, mild headache. At the time of reporting, the patient was recovered.
51 2021-01-18 pain in extremity At the time of the vaccine administration the vaccine was burning going in from the injection site u... Read more
At the time of the vaccine administration the vaccine was burning going in from the injection site up to my shoulder. I think the shot was given to high. The pain in the arm was bad for the first 3 days. The pain in the shoulder, almost right on the bone, is still present.
51 2021-01-18 tingling Tingling of Lips and face
51 2021-01-18 unresponsive to stimuli COVID 19 Vaccination administered by pharmacy staff. No adverse effect at the present time. Staff wi... Read more
COVID 19 Vaccination administered by pharmacy staff. No adverse effect at the present time. Staff will continue to observe adverse reaction. Will continue to monitor. Patient at start of shift awake in the bed. Pt at 3am was on the commode leaned to the side. Patient body still warm to touch no pulse. Called for assistance Asap. Cpr started promptly. Cpr given patient on floor 911 arrived at the scene at 3:10am Cpr rotated Between Nursing and EMT on Scene. Cpr was given to patient for over 45 minutes. Patient was pronounced at the scene at 3:50am. Call placed to Pt family by supervisor on shift. MD to be notified. AT 3:00am, I was notified by the nurse that resident is unresponsive. Upon entering room, resident was sitting on the commode unresponsive with absent respiration and pulse. Resident lowered down on the floor with 4 person assist. CPR initiated, AED pads placed on chest with no shock indicated. 911 called and EMT and paramedics arrived around 3:10am. ACLS performed until code stopped and pronounced death at 3:48am. I called and notified family member of his demise and awaiting for family to call us back for funeral arrangements.
51 2021-01-19 electric shock sensation Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , D... Read more
Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , Disiness, feels like electrical currents in head and ears. These symptoms have been all 7 days.
51 2021-01-20 feeling cold 12 hours later: 2 am -fever, chills, lethargy, bone pain persistent for 48 hours, Took one Tylenol ... Read more
12 hours later: 2 am -fever, chills, lethargy, bone pain persistent for 48 hours, Took one Tylenol For one week after the shot: rhinorrhea, sore throat, no fever.
51 2021-01-20 feeling cold body aches vomiting diarrhea temp 101 chills flat, red, splotchy rash
51 2021-01-20 nerve pain Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) bod... Read more
Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number El3248), via an unspecified route of administration in the left arm on 09Jan2021 06:30 at single dose for COVID-19 immunisation at hospital. Medical history included asthma, seasonal allergy, milk allergy, eucalyptus allergy. Concomitant medication included montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL), ciclosporin (RESTASIS, eye drop). The patient previously took tetanus vaccine and experienced drug hypersensitivity. The patient experienced low grade fever (99.9 F) body aches, nerve pain chills, headache, ear pain on 10Jan2021 08:00 with outcome of recovered. The patient took diphenhydramine hydrochloride (BENADRYL) 25mg every 6 hours and it relieved all symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
51 2021-01-20 pain in extremity feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattre... Read more
feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattress; no real taste; chest pressure/tightness/ general pressure in the chest; SOB/ SOB with movement; Body and joints with extreme pain everywhere it touched the mattress; a screw in left foot, it felt like it was on fire at some point during the night; My left leg ached up into my hip; fever 99.9; HA; eye pain; intermittent nausea; This is a spontaneous report from a contactable nurse (patient). This 51-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) on 07Jan2021 at 11:15, in right arm, for COVID-19 immunisation. Medical history included asthma, allergies to latex, banana, kiwi and acetylsalicylic acid (ASPIRIN). The patient received the first dose of BNT162B2 vaccine on 17Dec2020 at 19:45, lot number EJ1685, in right arm. The patient had no COVID prior vaccination. No other vaccine was given in 4 weeks. COVID was not tested post vaccination. Concomitant medications included thyroid (ARMOUR THYROID) and escitalopram. On 07Jan2021 at 12:30 the patient began experiencing SOB; assumed it was asthma, 2 puffs of albuterol were taken. At 13:30 she had still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 14:15 reported to the vaccination clinic and told them of symptoms, SOB with movement and general pressure in the chest. 2 paracetamol (TYLENOL) were taken. She had to check into the ER for observation. Oxygen saturation was checked for 2 hours. No change in symptoms, no worsening. She then left work in the ER and went home. At approximately 18:00 she ate dinner, no real taste, but needed to eat. At 18:30 she showered, at 20:00 she went to bed just feeling malaise, continued pressure in the chest and general soreness. 2 Tylenol. Body and joints with extreme pain everywhere it touched the mattress. She had a screw in her left foot, it felt like it was on fire at some point during the night. Her left leg ached up into her hip, she had fever 99.9, continued to 10Jan2021 with malaise, HA, eye pain, intermittent nausea. The events had not yet resolved at the time of report.
51 2021-01-20 pain in extremity Body aches, chills, fever, headache, sweats, dizzy, arm soreness, tender at injection site
51 2021-01-21 weakness Chills, nausea, I felt feverish but did not take my temperature, I had sweats, headache, warm and at... Read more
Chills, nausea, I felt feverish but did not take my temperature, I had sweats, headache, warm and at the injection site it swollen and red happened in the middle of the night. For the next 2 days I had extreme fatigue and after that I was fine (by Sunday). I did not have any energy but no chills or nothing. I took Tylenol and it helped me. I was able to return to work on Monday and as the day passed I started feeling like myself. I also developed a lump on my neck on 01/18/2021 on the left side (on my collarbone) and my PCP prescribed Doxycycline 2 tablets a day. I also developed a lump on my right side when I took the first dose and took a ZPack and that lump is still here on my neck.
51 2021-01-21 discomfort, hot flush An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tyl... Read more
An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tylenol as soon as I got home due to symptoms getting worse. That night I went to bed at 10pm and didn?t wake up till 7:45am (I was dead tired, I didn?t even hear my alarm). Jan/19/21. Soon as I got up, I experienced headache, vertigo, and this time with mild body aches/heavy feeling and mental fog (Tylenol helped relieved symptoms). Towards the afternoon, I also felt mild burning sensation in my eyes and somehow I felt hot flashes around my face only. Been taking my temperature with normal results. Jan/20/21 Still experiencing off/on headaches and light headedness, otherwise feels okay. All symptoms gone by end of the day.
51 2021-01-21 difficulty speaking I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-work... Read more
I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-worker told me my voice was strange, was hoarse. I was feeling fine. The next day I lost my sense of smell. Talked to my PCP and he told me to get tested for COVID, to my surprise I was positive. That was on the 28 or 29 of December. I also developed a lump on my neck on the right side and my PCP prescribed a Z Pack. I finished it but it never went away. I developed another lump on my left side when I took the second dose and I am taking Doxycicline for it.
51 2021-01-21 feeling hot, tremor Feeling of warmth on head and face at 9:00pm on 1/19/21 Woke with fever (99.6F), shaking chills, he... Read more
Feeling of warmth on head and face at 9:00pm on 1/19/21 Woke with fever (99.6F), shaking chills, headache at 4:00am on 1/20/21 Fever (100.6) joint pain, muscle pain at 9:00am Fever 101.0 at 1:00pm with intense headache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise. Fever 101.0 at4:00pm. Accompanied by symptoms listed above.Took 1,000mg Tylenol. Fever 101.0 at10pm. Accompanied by symptoms listed above. Took 1,000mg Tylenol. Insomnia. 1/21/21: Fever 99.0 degrees 4am. 1,000mg Tylenol. Intense headache and neck ache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise 1/21/21: Fever resolved at 6pm. Intense headache and neck ache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise 1/22/21: Body aches, headache, fatigue, malaise, fatigue, dizziness, nausea
51 2021-01-21 feeling hot Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly it... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly itch, pinpoint itch at my scalp and different parts of my body, fine rash in my bilateral forearm near my wrist, immediately I took Zyrtec, my rash started to fade but every now and then I fell fine itch in different parts of my body more than 2 hours now.
51 2021-01-21 flushing, tingling Tingles, Flush, Blood Pressure initial reading 172/79 at 3:09pm
51 2021-01-21 flushing sporadic flushing of the face and neck Increased flushing of the face and neck with wine/champagne
51 2021-01-21 migraine, pain in extremity HIGH FEVER (102), BODY ACHES, NAUSEA, CHILLS, MIGRAINE, ARM PAIN. THE SYMPTOMS CAME ON GRADUALLY OVE... Read more
HIGH FEVER (102), BODY ACHES, NAUSEA, CHILLS, MIGRAINE, ARM PAIN. THE SYMPTOMS CAME ON GRADUALLY OVER THE FIRST 24 HRS AND THEN STARTED TO DISSIPATE AFTER ABOUT 36 HRS AND WERE COMPLETELY GONE IN 48 HRS. TOOK ADVIL. SLEEP.
51 2021-01-21 muscle twitching Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/1... Read more
Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/103 pulse99) -patient refused to call 911 and asking staff to drive to hospital at 9:45am. hospital and nurse in charge at the facility, has contacted each other. At 11:46am nurse has inforemed me that hospital provided IVBenadryl/Fluid IV/Epipen, her heart still raised up, and has twitching, patient has left hospital and back to facility at 12:20pm
51 2021-01-21 tremor, flushing Throbbing pain R. Clavicle, shaking hands, Flushing, increased B/P
51 2021-01-22 weakness Chills, muscle aches and weakness, headache, tachycardia
51 2021-01-22 burning sensation 20 Jan 2021 face and arms reddening and burning about half hour after injection. 21 Jan 2021 fatigu... Read more
20 Jan 2021 face and arms reddening and burning about half hour after injection. 21 Jan 2021 fatigue, body aches, dizziness throughout day, went to bed very early no appetite, nauseous 22 Jan 2021 fatigue, body aches, dizziness. Temp 99.3 higher than normal. No appetite 23 Jan 2021 condition improved. No symptoms.
51 2021-01-22 feeling cold EXTREME COLDNESS started around 8am the day after the shot. Also all over body aches. 1/23/2021 wo... Read more
EXTREME COLDNESS started around 8am the day after the shot. Also all over body aches. 1/23/2021 woke up with patchy red torso rash
51 2021-01-22 feeling hot Received vaccine at 8:45am. Face felt hot and developed hives at 11:15am. Took Benadryl 25mg at 1pm.... Read more
Received vaccine at 8:45am. Face felt hot and developed hives at 11:15am. Took Benadryl 25mg at 1pm. Continued to work. Two Pepcid and ice at 2:30pm. Had little improvement. Took Claritin at 4:30pm then Benadryl 50mg. Symptoms resolved that am - no further issues.
51 2021-01-24 bell's palsy Received covid vaccine on December 30th. Developed Bells Palsy.
51 2021-01-24 feeling hot, hot flush Patient developed hot flashes (body and face getting warm) 60 minutes after receiving vaccination. P... Read more
Patient developed hot flashes (body and face getting warm) 60 minutes after receiving vaccination. Patient claimed she was feeling very hot no sign of itching or respiratory depression. Had patient under observation for 30 minutes while she cooled down with ice and water. Patient was also given 2 doses of Benadryl 25mg. Patient cooled down and went back to work after feeling better. However, we checked on patient again after a few hours to make sure she was ok. She was getting another episode of hot flash about 3:30 hours after first episode. Patient was given 1 more dose of Bendaryl. Checked patient BP systolic was slightly elevated (140s/70s)and HR was 101. Patient called husband to pick her up to go to PCP for monitoring. Patient claimed she only had a sore arm during her first COVID vaccine.
51 2021-01-24 numbness Within 10 minutes of 2 dose of COVID 19 vaccination, Patient experiences RIGHT side facial numbness.... Read more
Within 10 minutes of 2 dose of COVID 19 vaccination, Patient experiences RIGHT side facial numbness. Monitored patient vitals and facial symptoms until mostly resolved. With facial numbness, patient could still laugh, smile, wink, talk, breath. Vitals 30min post vaccination= 135/78 bp, 105 pulse, Temp 98.2F, O2 100%, 18 RR. 2hrs post vaccination= 138/90 bp, 96 pulse, Temp 97.3F, O2 100%, 18RR Right side facial numbness is resolving downward past eye. 2hr 20min post vaccination= 140/82 bp, 92 pulse, temp 98.2F, O2 100%, 18 RR Patient feels better and will notify Facility if facial numbness does not resolve.
51 2021-01-24 muscle spasms I felt light headed on the way home from the vaccine 1/23/21. At around midnight, I woke up with chi... Read more
I felt light headed on the way home from the vaccine 1/23/21. At around midnight, I woke up with chills. At 2am, I woke with more chills and a splitting headache. I took Tylenol which decreased the symptoms. All day on Sunday, I had a horrible headache, a fever of 101F, body aches (muscles and joints), cramping, nausea, terrible fatigue. I took Tylenol every 4 hours which did help some. Today, I feel fatigued, fever is gone, I feel nauseated.
51 2021-01-24 pain in extremity I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7... Read more
I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7 pm started exp chills, fever 101.9, the highest it got over next 2 days 100.5. The pain in my legs cause me to not be able to walk and severe headache. Due to the pain in my legs exp bruises in both legs of calf muscles. I felt as if I had Covid therefore I went to the doctor 4 days.
51 2021-01-24 tingling, numbness n/t arm and leg immediately after vaccine- numb /ting arm on follow up call next day. Pt felt immu... Read more
n/t arm and leg immediately after vaccine- numb /ting arm on follow up call next day. Pt felt immunization was administered too high on arm/shoulder. 1/25 pt is to get dose #2 this week and concerned re: still some numbness but also some ringing in the ear. Tells staff has had some ringing in the ear previous to vaccine mostly at night- this has now intensified to where she is also hearing it during the day. She has d/w her PCP- she is very unsure if she should get vaccine #2 or not.
51 2021-01-24 tingling Dizziness/ SOB about 30 minutes after injection, utilized inhaler, relaxed in bed. SOB and dizzines... Read more
Dizziness/ SOB about 30 minutes after injection, utilized inhaler, relaxed in bed. SOB and dizziness resolved GI symptoms started about 2 hours after injection - took protonix and maalox resolved by evening , Tingling in legs/feet in evening -Premedicated with Extra strength Tylenol and Benadryl for both doses of vaccine.
51 2021-01-25 weakness, pain in extremity With dose #1, some HA, arm pain (in particular arm pit pain). With this dose #2, uncontrollable rigo... Read more
With dose #1, some HA, arm pain (in particular arm pit pain). With this dose #2, uncontrollable rigors at about 12 hours post-dose for at least 1-2 hours, Tm to 103.3F, HA, myalgias, right leg pain, weakness and again, significant, severe arm pit pain on same side as injection site. At 34 hours, much improved (almost 100%), but arm pit pain did not dissipate until about day 5.
51 2021-01-25 feeling hot, numbness warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and t... Read more
warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and tightness in throat but did not close up. Was given Benadryl and Steiroid. chest x ray given which was normal. EKG taken which was abnormal but told was consistent with an older EKG. Was feeling better and about 90 minutes later felt warmth over my heart, my lips and mouth became tingly and both arms went numb and uncertain if my heart monitor showed abnormal. Was admitted overnight for observation. About 10 hours later had warmth in my chest, heart started beating fast, numbness in arms and around mouth and slight tightness in throat. Benadryl administered and heart calmed after couple of minutes, numbness went away after couple of minutes and tightness in throat went away after an hour. Again about 13 hours later the warmth in chest and heart racing only symptoms. Given another dose of Benadryl. The symptoms only lasted a couple of minutes. I also saw a cardiologist who ordered an echocardiogram just to rule out anything with my heart. It was normal. I was sent home with instructions to use Bendryl oral for 3 days every 12 hours. I was told it could be from vaccine and I was to follow symptoms for 2 weeks and if not better to see cardiologist to look at other reasons. I have taken the Benadryl for 3 days every 12 hours and did not have any other episodes with my heart. I am on day 6 now and I have joint pain and headache.
51 2021-01-25 numbness, facial pain Patient developed unilateral facial numbness 2 days after the vaccine. The numbness subsided and was... Read more
Patient developed unilateral facial numbness 2 days after the vaccine. The numbness subsided and was replaced with pain. No weakness or drooping. No eye involvement. Patient's pain was located on the right side of the jaw below the eye. Patient was treated with prednisone on the same schedule of dosage as used for Bell's Palsy. Patient saw immediate improvement from the prednisone and is no longer having the pain. She never developed any other complications.
51 2021-01-25 migraine Triggered a migraine within a day. Within 3 days, muscle weakness and fatigue. On day 11, muscles i... Read more
Triggered a migraine within a day. Within 3 days, muscle weakness and fatigue. On day 11, muscles in jaw tight - unable to open or close my jaw. Difficult to eat.
51 2021-01-25 migraine Same day, triggered migraine that lasted 3 days; By Day 3, muscle weakness and fatigue; Day 11, coul... Read more
Same day, triggered migraine that lasted 3 days; By Day 3, muscle weakness and fatigue; Day 11, couldn't open my jaw or close it. Went to ER 1/25/21. Seeing PCP on 1/27/21
51 2021-01-25 tingling, sensory loss, numbness numbness for 10 days and is ongoing/numbness and loss of sensation in the 4th and 5th digit, then on... Read more
numbness for 10 days and is ongoing/numbness and loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine/numb all over her spine; loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine/loss of sensation in the left 4th and 5th finger that then went to her shoulder and back; paresthesia; having trouble with dexterity; This is a spontaneous report from a contactable physician (neurologist) via a Pfizer-sponsored program. A 51-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration in left arm, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took thimerosal and experienced allergy. The physician reported that the patient received the first dose of the vaccine and has been experiencing numbness for 10 day from an unspecified date. This patient received the injection in the left arm and she started experiencing numbness and loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine, she's still experiencing ongoing numbness the numbness in her 4th and 5th digit. The patient experienced loss of sensation in the left 4th and 5th finger that then went to her shoulder and back; and felt numb all over her spine, all on unspecified dates. The patient was having trouble with dexterity. The physician ordered an MRI for the patient but does not have the results back yet. The physician asked if it is safe for the patient to get the second dose. The second dose will be on 15Jan2021. The outcome of the event numbness was not recovered, and the outcome of the remaining events was unknown. Information on the lot/ batch number has been requested.
51 2021-01-26 flushing, weakness metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went t... Read more
metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went to the emergency room since she didn't feel any better; mid chest tightness and weakness; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730, expiration date: Mar2021), via an unspecified route of administration on 30Dec2020 12:00 at single dose on deltoid left for COVID-19 immunisation. Medical history included patient was working in healthcare and around Covid positive patients daily. There were no concomitant medications. 10 minutes after getting bnt162b2, patient noticed side effects. Patient had a metallic taste in throat and a few more things. Right after getting it she had a flushed feeling in her body and legs, similar like IV contrast. 10 minutes after that so about 20 minutes later she had mid chest tightness and weakness that was gone after about 40 minutes to an hour. Patient was unable to provide any seriousness criteria, stating it was scary for a moment and she didn't know what it was, but the mid chest tightness could have progressed to something more serious. That was how she felt at that moment, but after it was all gone, it was not serious. She did not know why or what the reason was or if she was lucky or what. Patient was sitting for 10 minutes after receiving Pfizer COVID vaccine and was doing something on her phone when she started experiencing these symptoms unexpectantly. Eventually the nurses observing her after a half hour took her to the emergency room since she wasn't feeling any better. Patient had emergency room visit for all events. Outcome of events was resolving.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported mid chest tightness and the administration of the COVID 19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
51 2021-01-26 numbness and pain in extremities Pt received Pfizer vaccine 2nd dose on 1/11/2021. On 1/12/2021, pt had severe lower back seen her P... Read more
Pt received Pfizer vaccine 2nd dose on 1/11/2021. On 1/12/2021, pt had severe lower back seen her PCP and lower back pain progressed on 1/18/2021. Employee went to ER and was discharge. She continued to have back pain and went ER on 1/24/2021, she was admitted and doctor related her symptoms/neuropathy to the COVID vaccine, per employee. On 1/24/2021, admitted to Hospital for treatment included CT scan, MRI scan, medication such as morphine, dulaudid, Norco and gabapentin. Current using a walker for stability.
51 2021-01-27 weakness, migraine Started with an ocular migraine( I have had these in the past but not for a couple of years) on Thur... Read more
Started with an ocular migraine( I have had these in the past but not for a couple of years) on Thursday the 21st 2 days after vaccination, On Friday, still had dull headache. Woke up Saturday with a slight fever. It progresssed until Sunday and I became very weak, horrible headache, extreme dizziness. This is still going on. The fever left yesterday. But am still weak and having severe dizziness and fullness in my head. I have had labrinthitis in the past but haven't had any major issues for 6 years when I had the flu. Went to doctor yesterday. Flu was negative. She thought maybe another an upper respiratory virus which I question because I only go to work with a small group and come home and no one at my work has been sick. I also always start out with a sore throat when I have some sort of URI and I never had this. I do not have any congestion to speak of. I am a rule follower and always wear my mask and to be honest wear gloves if I have to touch anything. but I do not go anywhere except for work. I was exposed to covid the day after vaccination but have tested negative 2 times. I had the RT-PCT test. I am just trying to take it one day at a time
51 2021-01-27 muscle twitching rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; musc... Read more
rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; muscle aches; swelling on left side of body including facial, arm pit, and arm down toward elbow, upper back under shoulder blade; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), intramuscular on 12Jan2021, at 13:00 at single dose (left arm) for COVID-19 immunization. Medical history included Covid-19 (prior vaccination). The patient was not pregnant and had no known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN). On 12Jan2021, at 15:00, the patient experienced fatigue, headache, muscle aches, swelling on left side of body including facial, arm pit, and arm down toward elbow, and upper back under shoulder blade, rash on chest and upper back, sore throat, and muscle twitching around left eye. The patient had no treatment for the events. The patient had no other vaccine in 4 weeks; and patient was not Covid tested post vaccination. Outcome of the events was not recovered.
51 2021-01-27 pain in extremity About 3 hours after the 1st dose of the vaccine, I was dizzy and lightheaded. This continued for 24... Read more
About 3 hours after the 1st dose of the vaccine, I was dizzy and lightheaded. This continued for 24 hours. I then had a fever of 101.5 for about 30 hours. My arm is extremely sore. I now have a splitting headache.
51 2021-01-27 tingling, hot flush, numbness slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuf... Read more
slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff; slight tingling and numbness of her face and cheeks/little tingling numbness in her face; slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff/she has not had symptoms for years, potentially initiated by being vaccinated; Headache; Diarrhea; Stomach upset; warm flushed feeling; heavy metallic taste to her mouth; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing multiple sclerosis (MS) from 2012 (she has not had symptoms for years), tingly stuff/tingling and numbness (MS symptoms). There were no concomitant medications. The patient experienced metallic taste in her mouth, a slight tingling and numbness of her face and cheeks. The patient reported that she also has a history of MS that has been controlled and she has been without symptoms for years. She stated the tingling could be a symptom of MS, potentially initiated by being vaccinated. She stated that the tingly stuff concerned her, she got a little panicky because that can be a symptom of MS and she did not have symptoms for years. The patient clarified that on 07Jan2021, she took the vaccine. On 07Jan2021, she experienced heavy metallic taste to her mouth two hours after the injection, headache, diarrhea, stomach upset, and warm flushed feeling. On 08Jan2021, she experienced little tingling numbness in her face. She stated that she has MS prior to the vaccine and reported that numbness and tingling can be MS symptoms. She has not had symptoms for years. The patient did not receive treatment for the events. The outcome of "heavy metallic taste to her mouth" was recovering (reported as "improved but persisting"); paraesthesia and hypoeasthesia were recovering; headache, diarrhea, stomach upset, and warm flushed feeling were resolved on 09Jan2021.
51 2021-01-28 inability to speak cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble... Read more
cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble finding words; extreme fatigue; nausea; achiness at joints; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (vaccine location: left arm), on 23Dec2020 17:00, at single dose, for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes - all on 24Dec2020. These symptoms never left up until day 21 when the patient received her next shot. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination. It was unknown if treatment was received for the adverse events. The patient was recovering from the events.
51 2021-01-28 weakness headache; Diarrhea; dizziness/severe dizziness; weakness/very weak; muscles and joints are aching an... Read more
headache; Diarrhea; dizziness/severe dizziness; weakness/very weak; muscles and joints are aching and painful; muscles and joints are aching and painful; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no: EL1284, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose on left arm for Covid-19 immunization. Medical history included pre-diabetes 3-4 years ago. The patient's concomitant medications were not reported. Certified Nursing Assistant said that she has been experience some side effects from the Pfizer-BioNTech Covid-19 Vaccine which she took two days ago, 13Jan2021. She said she was having side effects include headache on an unspecified date. Furthermore, she experienced diarrhea, dizziness/severe dizziness, weakness/very weak and muscles and joints are aching and painful on 14Jan2021. The outcome of all events was not recovered except for headache that was unknown. She wanted to know what she should take and what she should do about these symptoms.
51 2021-01-28 feeling hot Patient reported tongue numbness and throat itching sensation within three minutes of vaccine admi... Read more
Patient reported tongue numbness and throat itching sensation within three minutes of vaccine administration. BP 131/87, HR 80, O2 97%. Patient then developed macular rash on bilateral arms and described sensation of generalized warmth about 15 minutes after vaccine administration. presented to vaccine clinic for consult, patient was then transferred to ER via stretcher.
51 2021-01-28 numbness Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her a... Read more
Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her and was painful for two days, she could barely move her arm; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing asthma for approximately 25 years ago. There were no concomitant medications. After she took the first dose, on an unknown date, her arm killed her and was painful for two days, she could barely move her arm. She also had numbness in her mouth, face, jaws, and cheeks that lasted about 3 hours. The outcome of the events was unknown.
51 2021-01-28 migraine, pain in extremity Started approx 1/17/21 with migraine type headache, then by 1/19/21 had arm soreness, muscle weaknes... Read more
Started approx 1/17/21 with migraine type headache, then by 1/19/21 had arm soreness, muscle weakness, joint pain and headache. All symptoms improved 1/25/21 except lingering headache which is still current.
51 2021-01-28 pain in extremity Started with body aches about 14 hours after injection progress to severe joint and bone aches espec... Read more
Started with body aches about 14 hours after injection progress to severe joint and bone aches especially in hands and feet . Stabbing random headaches , fever 101, chills, sweating these symptoms lasted about 24 hours . Then about about 36 hours I woke up in the morning with swollen lymph nodes under left arm very painful. All other symptoms have gone but swollen lymph nodes are persisting current time since dose is about 48hrs.
51 2021-01-28 tingling, pain in extremity, feeling cold Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain;... Read more
Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain; headache moving around and off and on; tingling legs; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) via intramuscular on right arm on 17Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, attention deficit hyperactivity disorder (ADD). Concomitant medication included celecoxib (CELEXA), dexmethylphenidate hydrochloride (FOCALIN), ibuprofen, paracetamol (TYLENOL). No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient previously took cefixime (FLEXERIL) and experienced drug hypersensitivity, naproxen and experienced drug hypersensitivity. On first day after vaccine the patient experienced sore arm, weird taste in mouth, tingling lips, feeling very cold, pain ache under armpit, neck pain, headache moving around and off and on, tingling legs, all on 17Jan2021 08:45. No treatment received for the events. The outcome of the events was unknown.
51 2021-01-28 tingling Elevated heart rate at 7pm on evening of vaccine (administered at noon); tingling sensation all over... Read more
Elevated heart rate at 7pm on evening of vaccine (administered at noon); tingling sensation all over; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) intramuscularly at right arm on 14Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. The patient's concomitant medications were not reported. The patient experienced elevated heart rate at 7pm on evening of vaccine (administered at noon), tingling sensation all over. Laid down and issue resolved within 2 hours. No treatment received. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovered on 14Jan2021.
51 2021-01-29 feeling hot, flushing Patient began to feel hot, vital signs were assessed and patient was found to be tachycardic and flu... Read more
Patient began to feel hot, vital signs were assessed and patient was found to be tachycardic and flushed. Given history of other allergic reactions and rapid onset of symptoms, patient was sent to the ED for additional f/u.
51 2021-01-30 flushing, weakness 1st dose - tachycardia, onset within a few minutes of injection, HR over 100 for about 5 minutes. ... Read more
1st dose - tachycardia, onset within a few minutes of injection, HR over 100 for about 5 minutes. 2nd dose - tachycardia, onset within a few minutes of injection accompanied by nausea. Had to lie down. Felt fine after a few minutes of lying down. Flushed face. RN thought I was dehydrated, so drank a bottle of water. Had eaten breakfast that day as well as two cups of coffee and some water. Blood pressure elevated lying down and significantly dropped upon standing. After 30 minutes, orthostatic hypotension was gone. About 4 hours later while at home and having already had another meal and lots of water, developed. Orthostatic hypotension again - I simply could not stand for more than 30 seconds without feeling extremely weak and about to pass out. This went away quickly. Then, around 730 at night I stood up to walk across the room and had to collapse into a chair, as I was about to pass out. Again, orthostatic hypotension. No sxs the day following injection.
51 2021-01-30 pain in extremity The day after I got my vaccine, I started to have pain in my right arm (opposite arm of vaccine). I... Read more
The day after I got my vaccine, I started to have pain in my right arm (opposite arm of vaccine). It kept getting more intense every day, and I developed a rash on my right arm, right shoulder, and right side of my chest. It started to scab over in parts. I saw my nurse practitioner on 1/19/21 who said it was most likely shingles, and prescribed anti viral and nerve pain meds.
51 2021-01-31 flushing 1250: presents with heart racing, HR: 144, BP: 142/90, Upper lip numbness, throat tightening, felt f... Read more
1250: presents with heart racing, HR: 144, BP: 142/90, Upper lip numbness, throat tightening, felt flush, complained of dryness to throat, drank a glass of water and tolerated Rapid response called; transferred to Ed
51 2021-01-31 muscle spasms, migraine malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; ... Read more
malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
51 2021-01-31 pain in extremity Arm a little sore . That's about it so far.
51 2021-01-31 pain in extremity About 3 hours after the 1st dose of the vaccine, I was dizzy and lightheaded. This continued for 24 ... Read more
About 3 hours after the 1st dose of the vaccine, I was dizzy and lightheaded. This continued for 24 hours. I then had a fever of 101.5 for about 30 hours. My arm is extremely sore. I now have a splitting headache.
51 2021-02-02 numbness, facial paralysis On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my n... Read more
On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my neck, jaw, and ear. On Saturday, 1/30, I woke up, and the right side of my face was numb, and my right eye would not blink. I went to ER. When they took my vitals, I had high blood pressure and fever. They did a CT scan of my head and admitted me. I was diagnosed with Bell's Palsy. I was discharged on Sunday, 1/31, with medications: Valacyclovir 1 gram three times a day and Prednisone 20 mg three times a day. I was instructed to followup with a neurologist, immunologist, ophthalmologist, and my primary care physician.
51 2021-02-02 numbness States she has had arm and hand numbness in L hand since 1st vaccine. States it started within 15 m... Read more
States she has had arm and hand numbness in L hand since 1st vaccine. States it started within 15 minutes of last injection. Denies any other symptoms.
51 2021-02-02 pain in extremity, brain damage, unresponsive to stimuli **Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze de... Read more
**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze deviation at midnight and admitted to hospital (last seen normal around 7 pm 1/24/2021). Intubated in ED, ABG 6.98/17/186 on 40%, Bicarb <5, Scr 1.4, Lactate 1, Wbc 20.3, BP 101/45-- >95/41, Temp 94.3, RR 23-32. Acidotic and initially required norepineprine for hypotension management (stopped 1/26/2021 0400 am) 1/26 to 2/1/2021 - supportive care for encephalopathy (anoxic vs. ischemic brain injury), ARF, HTN, MSSA growth in resp culture (no respiratory distress, on antibiotic) 1/28 GCS:E4VTM4; 1/29 GCS: EV4VTM4 with intact protective reflexes, extubated 2 pm 2/1 arousable, follows very simple commands, non verbal
51 2021-02-02 pain in extremity Woke up 1/7/21 at 4:00 am with a temp of 102.0, Nausea, body aches, chills, arm pain, joint pain, ex... Read more
Woke up 1/7/21 at 4:00 am with a temp of 102.0, Nausea, body aches, chills, arm pain, joint pain, extreme thirst and fatigue. Tylenol taken temp continued to be 102 and increased to 102.4. All symptoms lasted until until 1/8/21 5am woke up sweating temp down to 99.8, arm pain, fatigue. 1/9/21 all symptoms resolved.
51 2021-02-03 feeling of body temperature change, discomfort, pain in extremity chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm... Read more
chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.
51 2021-02-03 numbness She got her first vaccine o 12/30/20 and by 1/5 started noticing some swelling and numbness in her f... Read more
She got her first vaccine o 12/30/20 and by 1/5 started noticing some swelling and numbness in her face, it has slowly gotten worse and now has a drooping eye, worsening facial numbness and droop.
51 2021-02-03 pain in extremity, discomfort This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hell... Read more
This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hello, I had received my vaccine earlier today and just awoken to chest pains. I do not think it wise to be there for my shift in the next 8 hrs. I will stay and observe for additional symptoms. I was on vacay and had out-of-office notice set for my email. I discovered this email yesterday while catching up on emails. I immediately called her. She described the details of the events; stated she has not sought medical care; all symptoms resolved spontaneously but still has some intermittent, mild SOB> She sent me this email describing the reaction: Here explanation of the reaction: Thank you for the follow up. Below is a list of symptoms I experienced after I received my initial dose of the Pfizer vaccine. I am scheduled to receive my 2nd dose next week on the 13th of January. following up: I received my shot at 8:15 am, within approximately 45 min I felt a very slight heaviness to my breathing something similar to allergy season breathing, and a slight headache on my rt temple. This was nothing that stopped me or slowed me down that day. At ~ 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At ~ 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I noticed much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopeful that all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night." I advised she contact her PCP to determine if follow up is indicated given persistent, intermittent cough and SOB.
51 2021-02-03 pain in extremity her arm was sore and hurting; This is a spontaneous report from a contactable consumer reporting for... Read more
her arm was sore and hurting; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284 /expiration date: not provided), via intramuscular route of administration, on 29Dec2020 10:15 AM (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was none. Concomitant medication was not provided. On an unknown date, the patient experienced her arm was sore and hurting. The outcome of the event her arm was sore and hurting was unknown.
51 2021-02-04 weakness FEVER, SWEATS/CHILLS, FATIGUE, FLUTTERING, PALPITATIONS, HEADACHES, WEAKNESS, SHORTNESS OF BREATH, C... Read more
FEVER, SWEATS/CHILLS, FATIGUE, FLUTTERING, PALPITATIONS, HEADACHES, WEAKNESS, SHORTNESS OF BREATH, COUGH, LOWER ABDOMINAL PAIN, MUSCLE PAIN, CHEST PAIN. PAIN AND SWELLING AT INJECTION SITE.
51 2021-02-04 weakness Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle o... Read more
Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle of the night, had increased SOB and chest weakness. Describes as felling "Not well." Drank water. Felt better. Went back to sleep. 2/4: Patient c/o nasal congestion, slight blurred vision, increased SOB/chest weakness, had body aches, slight swelling in neck lymph node (hx of swelling due to abscess). Felt better as day progressed but in afternoon @ 3:30 p.m. while at store with family, had to leave to sit in car due to fatigue and reoccurring SOB. Minor SOB episode throughout the day. Slept well at night. Took Ibuprofen 400 mg PO x1 which improved body ache.
51 2021-02-04 numbness Numbness in face, dizziness, tiredness, pain in muscle at injection site, joint pain
51 2021-02-04 muscle spasms Pt had 2nd vaccine, went home and started having "cramping" in all of her muscles. It became bad en... Read more
Pt had 2nd vaccine, went home and started having "cramping" in all of her muscles. It became bad enough that she was taken to local ED where she then started coughing up blood, required intubation and about 6 hrs later, died.
51 2021-02-04 pain in extremity 02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to inj... Read more
02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to injection site upon waking; I took Tylenol 8 hrs and drank 20 oz water. 02/03/2021 at 130am running nose and nausea started. At 9am I took some alka seltzer cold tabs. At 5pm I realized pain to right arm was worsening after full inspection I recognize swollen axillary lymph nodes; entire arm pit is swollen. I applied moist heat compress throughout the night and took more Tylenol. I hydrated with water and just layed around resting my body. 02/04/20 swelling continues with some decreased visible; pain to right arm pit continues and nausea continues.
51 2021-02-04 tremor Uncontrollable body shakes and I am very, very cold with no fever.
51 2021-02-05 weakness Extremely achy, tired ,rundown, headache. I took Tylenol, used a heating pad ,rested ,drank plenty o... Read more
Extremely achy, tired ,rundown, headache. I took Tylenol, used a heating pad ,rested ,drank plenty of fluids, was fine by the next day
51 2021-02-06 breast pain, pain in extremity Induration in axilla of left arm headache fever pain and swelling of left breast pain on both thighs... Read more
Induration in axilla of left arm headache fever pain and swelling of left breast pain on both thighs and knees redness at injection site urticaria and warmth generalized body pain eye redness
51 2021-02-06 tremor Within 5 hours of the second vaccination (3pm) fever set in @100.5..throughout the nite the fever co... Read more
Within 5 hours of the second vaccination (3pm) fever set in @100.5..throughout the nite the fever continued to rise. At the onset of fever, 650mg of acetaminophen was taken. Went to bed and awoke around 4am with severe chilling/shaking and high fever of 105, took 400mg ibuprofen. Awoke 6am, shaking and chills again, fever down to 103.6. Fever did not break completely until 48 hours after vaccine dose.
51 2021-02-07 weakness Severe Nausea Headache Weakness Tiredness Dreams Fever Muscle pain Chest pressure
51 2021-02-07 feeling hot felt warm; lower lip was slightly itchy; pinpoint itch mostly in her scalp left ear; cluster fine ra... Read more
felt warm; lower lip was slightly itchy; pinpoint itch mostly in her scalp left ear; cluster fine rash in her bilateral forearm near the wrist; on and off pinpoint itch in different parts of her body; medical history of Chronic Hep B, borderline DM, HTN, high cholesterol; medical history of Chronic Hep B, borderline DM, HTN, high cholesterol; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via intramuscular route of administration on 22Jan2021 at 08:15 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included Chronic Hep B, borderline DM, HTN, high cholesterol. Concomitant medications included losartan, amlodipine, atorvastatin, metformin, fish oil, and docusate sodium (COLACE). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730) on 04Jan2021 at 08:30 am (age: 51 years), intramuscular, in the left arm for COVID-19 immunization; flu vaccine in 2010 and experienced allergies; and Penicillin G and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 22Jan2021 at 08:35, the patient felt warm. At the same time, her lower lip was slightly itchy. She also had pinpoint itch mostly in her scalp left ear and cluster fine rash in her bilateral forearm near the wrist, and four hours on and off pinpoint itch in different parts of her body. The patient was given Zyrtec as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
51 2021-02-07 flushing Headache; flush; diaphoretic; stiff neck; This is a spontaneous report from a contactable pharmacist... Read more
Headache; flush; diaphoretic; stiff neck; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: cl3249) intramuscularly at left arm on 22Jan2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history included hypothyroid, asthma, seasonal allergies and known allergies: bee stings. The patient was not pregnant. No other vaccine in four weeks. Other medications in two weeks included levothyroxine. The patient experienced adverse events included headache, flush, diaphoretic, stiff neck; with start date on 22Jan2021 at 12:00 PM. Treatment ibuprofen received for events. The outcome of events was resolving. No covid prior vaccination and no covid tested post vaccination.
51 2021-02-07 pain in extremity, weakness Swelling and very painful arm. The size of a grapefruit. Fever, headache, weakness and body aches
51 2021-02-07 pain in extremity Sore arm at the site of injection. Extreme pain and swelling in big right toe. Toe also felt hot to ... Read more
Sore arm at the site of injection. Extreme pain and swelling in big right toe. Toe also felt hot to the touch. I iced both locations and ultimately took 2 200mg Advil tablets. Arm is still tender the second day. The toe felt fine all day then at 5:30pm it started to feel like it was swelling again. I immediately took 2 200mg of Advil.
51 2021-02-07 tingling Tingling in the hands; This is a spontaneous report from a contactable other healthcare professional... Read more
Tingling in the hands; This is a spontaneous report from a contactable other healthcare professional (patient). A 51-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ED1283), intramuscularly on 15Jan2021 in the Right arm at single dose for COVID-19 immunization in hospital. Medical history included Celiac Disease, Dystonia, Hypothyroid, GERD (Gastrooesophageal reflux disease), Anemia, Ovarian cancer, Migraines, gastroparesis and known allergies with Penicillin. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took and had known allergies with prochlorperazine maleate (COMPAZINE), nicergoline, metoclopramide, dihydroergotamine, doxycycline, prochlorperazine, sulfamethoxazole and trimethoprim (SULFAMETHOXAZOLE-TRIMETHOPRIM). The patient experienced tingling in the hands on 18Jan2021. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
51 2021-02-08 numbness, facial paralysis, mild one side paralysis 1/12/21: Pt presented to ED with L sided facial droop, L sided weakness to arm and leg, numbness to ... Read more
1/12/21: Pt presented to ED with L sided facial droop, L sided weakness to arm and leg, numbness to L face L arm and left leg. Presentation consistent with acute ischemic stroke. Risks and benefits discussed with the patient, who agreed to proceed with tPA. MRI brain 1/12: "Acute infarct right MCA territory predominantly involving the right parietal/insular lobes. No acute hemorrhage or midline shift." Started on aspirin 325 mg daily and rosuvastatin dose increased to 40 mg daily 24 hours post tPA. Patient reported a history of a-flutter many years ago for which she was on a beta-blocker, but the diagnosis remains unconfirmed. Tele reviewed during stay, no arrhythmias. ECHO, normal EF, NO PFO. Discharged to rehab on 1/15.
51 2021-02-08 migraine yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 10... Read more
yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 105.00 with Tylenol; increased dizziness/light-headed; body aches; severe headache; nausea; chills; sweating/sweats; Fatigue; feeling crappy; blood pressure tends to be low but was 95/81 at the time she got the shot; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 25Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration on 19Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. Medical history included ongoing severe Crohn's disease, pneumonia, allergy to eggs/anaphylactic reactions to eggs, anaphylactic with bee stings on 2020 (this has happen twice in 2020), collapsed her lung (reaction to anesthesia that collapsed her lung), high fever, anaphylactic reactions. Concomitant medication included sertraline (SERTRALINE), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took Hep B and experienced fever, flu like symptoms, achy, and lethargic (no issue with the first 2 doses but with the 3rd dose she had a high fever); MMR and had an adverse reaction. It was reported that the shot was given on 19Jan2021. She experienced the following severe dizziness which started that day (17:45) and lasted 3 days. It has resolved. Nausea which started that day (17:45) and stayed constant for 3 days. Now it has only been happing in the late afternoons or evenings. Light headed which started that day and last 3 days. Headache (17:45), the initial headache felt like her whole head was going to explode into a 1000 piece. Now it just starts about 4-5pm in the evening. It was better and not as severe but like a migraine with nausea (17:45), feeling crappy (17:45), and body aches. Body aches which started on the day of the shot (17:45) and lasted 3 days. Fatigue which started on the day she got the shot (17:45) and was ongoing in the evening now chills and sweats which started on the day she got the shot and was ongoing. Her husband asked about if this was being related to the change of life but she doesn't think so. Fever which happened on the day she got the shot (17:45) but not at the site, later that night and was 105.00 with Tylenol. It has resolved. She noted that her blood pressure tends to be low but was 95/81 at the time she got the shot (17:45). The patient has not taken her blood pressure and does know if this has resolved. It was relayed that she took Tylenol and Benadryl before the shot due to her history and was still taking it as treatment for the symptoms. She has a lot of drug and other allergies, the only that was anaphylaxis was bees and egg. This was why she brought 2 EpiPens when she had the shot. She didn't have to use her EpiPen and was really proud of that but did have some reactions. The patient reported she did not go to the doctor. At this point she was somewhat expected that she had a not great reaction so the fact that she could still breath after getting it was a good thing. She also noted she could not have driven home due to dizziness. The patient was not brought to the emergency room and did not went to a physician's office. The patient has an ongoing medical history of Crohn's disease and reported that yesterday (as reported) started a flare up but she was not sure if this was related to the vaccine use. The patient recovered from fever on 23Jan2021; was recovering from dizziness, body aches, severe headache, nausea, chills, sweating, and fatigue; while outcome of blood pressure tends to be low, feeling crappy and Crohn's flare up was unknown.
51 2021-02-08 pain in extremity Pain to left underside of arm, travels from armpit down left wrist, centralizes in elbow, difficulty... Read more
Pain to left underside of arm, travels from armpit down left wrist, centralizes in elbow, difficulty moving left arm above head, feels like pulling sensation. Pt. tried warm compresses, showers, exercises, motrin all started on Sunday 2/7/21 with some relief. Pt. states that she has been taking one dose of motrin ever since with some relief. Pt. denies numbness and tingling in fingers.
51 2021-02-08 pain in extremity I am sicklemic, and after two doses and 5 days later started a painful acute crisis, everywhere, tho... Read more
I am sicklemic, and after two doses and 5 days later started a painful acute crisis, everywhere, thorax. The first dose in January was on my left deltoid and after some days my arm hurt and thorax, I thought after years without a crisis due to my illness, this was an isolated event but after the second dose, received in my right deltoid, I had a repeat crisis on my thorax which made me think the vaccine could have caused it. I had spent years without a crisis that required me to rest for three days and taking analgesics at a maximum dose and 3 liters of water daily.
51 2021-02-09 muscle spasms Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under ... Read more
Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under arms; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular in the left arm on 22Jan2021 09:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to IV dye. The patient was not pregnant at the time of vaccination. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the left arm on 31Dec2020 09:30 at the age of 51 years old for COVID-19 immunization and codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 22Jan2021 10:00, the patient experienced nausea, vomiting, body aches, chills, constipation, cramping, swollen lymph nodes in neck and under arms. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
51 2021-02-09 pain in extremity General fatigue Red, sore arm
51 2021-02-09 tingling Received 2nd vaccine on 2/5/21 and on 2/6/21 started having a headache. Experienced tingling and pin... Read more
Received 2nd vaccine on 2/5/21 and on 2/6/21 started having a headache. Experienced tingling and pinprick sensation over her entire body. Went to ER on 2/8/21.
51 2021-02-09 speech disorder, tremor Had the first COVID vaccine on 1/8 and did a hike on 1/9 that was about 2-3 miles and did fine and t... Read more
Had the first COVID vaccine on 1/8 and did a hike on 1/9 that was about 2-3 miles and did fine and then developed severe exhaustion on 1/10 while hiking 2-3 miles and had trouble getting back due to exhaustion. She then had to stay in bed due to exhaustion for about 2 weeks. Also developed 2 days after the vaccine, symptoms of nausea, shakiness and sweating. Brain fog, decreased short term memory loss/trouble with word finding with tachycardia started about 10 days after the vaccine. Baseline, has a mild stutter which she does not think worsened with her symptoms, but was not sure. Difficulty with word finding and memory most unusual for patient that she is a scientist and a poet. She developed symptoms of dysuria and incomplete bladder emptying on January 13. I saw her for a telephone visit on January 20, ordered urine tests and empirically treated for UTI with Augmentin.
51 2021-02-09 tenderness Swelling in the area at the base of the neck on the left shoulder; swelling in the area at the base ... Read more
Swelling in the area at the base of the neck on the left shoulder; swelling in the area at the base of the neck on the left shoulder, (there was a small lump in that area); Soreness/tenderness in the area near the collarbone; Soreness/tenderness in the area near the collarbone; Pain in the left armpit; Swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELI283 and expiry date: unknown), via an unspecified route of administration on the left arm, on 18Jan2021 12:15 at single dose for covid-19 immunisation. Medical history included high blood pressure and seasonal allergies. Patient was not pregnant at the time of vaccination. Concomitant medication included losartan potassium, naproxen sodium (ALEVE) and unspecified OTC allergy medications. There were no other vaccines received within 4 weeks prior to COVID vaccination. The patient experienced pain in the left armpit and swollen lymph node on 23Jan2021 11:30. On 24Jan2021 17:00, patient experienced swelling in the area at the base of the neck on the left shoulder, (there was a small lump in that area) and soreness/tenderness in the area near the collarbone. Patient had not recovered from the events and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
51 2021-02-10 discomfort Facial pressure, anxiety/adrenaline surge
51 2021-02-10 flushing, burning sensation, pain in extremity 2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch... Read more
2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-02-10 pain in extremity Arm pain, Fever 102, body aches, chills, back pain, nausea/vomiting which began 3 hours following in... Read more
Arm pain, Fever 102, body aches, chills, back pain, nausea/vomiting which began 3 hours following injection with both injections.
51 2021-02-10 pain in extremity LT Arm Pain and swelling of arm and Lt hand , treated with hot and cold packs and pain relievers, s... Read more
LT Arm Pain and swelling of arm and Lt hand , treated with hot and cold packs and pain relievers, still have pain and swelling 5 weeks after shot
51 2021-02-11 weakness Local arm pain close to injection site, dizziness, back pain close to elbow to the head, dirrhea, vo... Read more
Local arm pain close to injection site, dizziness, back pain close to elbow to the head, dirrhea, vomiting, headache, burping, bitter taste in mouth, body aches, weakness, farting, tiredness. Still experiencing adverse effects.
51 2021-02-11 numbness, facial paralysis Shortly after receiving vaccine; whole right side of her face went numb. Pt took Benadryl after inje... Read more
Shortly after receiving vaccine; whole right side of her face went numb. Pt took Benadryl after injection afraid it was an allergic reaction. Pt seen by MD in office; noted with right facial dropping .
51 2021-02-11 tenderness Swollen/ tender collar bone and area. Neck pain all on right side along with knot that maybe lymph n... Read more
Swollen/ tender collar bone and area. Neck pain all on right side along with knot that maybe lymph node swelling.
51 2021-02-12 bell's palsy The next day it started with neck pain. Like I slept wrong. Lasted 2 days or so. Then I was diagn... Read more
The next day it started with neck pain. Like I slept wrong. Lasted 2 days or so. Then I was diagnosed with Bell?s palsy on 1/30/2021
51 2021-02-14 weakness Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up t... Read more
Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11.
51 2021-02-14 flushing Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Other- Anxiety/Panic-Medium
51 2021-02-14 tingling Patient is a 51 year old female c/o possible reaction to covid vaccine. C/o tingling of lips, left a... Read more
Patient is a 51 year old female c/o possible reaction to covid vaccine. C/o tingling of lips, left arm, hands and feet. Hives and itching. Received 1st dose of covid vaccine at 1635 today. Developed sxs 2-3 minutes after. Was given bendryl 25 mg po at 1643. Was brought by nurse. Hx of chronic urticaria, takes claritin daily with control. Hx of allergic reaction to bactrim. Has epi pen with her. Nurse brought note from Doctor, to order tryptase lab
51 2021-02-15 feeling cold, pain in extremity At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three ti... Read more
At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three times it's size. I couldn't move my arm for 24 hours. Arm pain was gone after 24 hours. Two days after - I was freezing cold, on the couch. Following day, I called my doctor. He told me to rest. I had a high fever and I had body aches. I was really cold. I felt like I had the flu for about a week - missed a couple days of work.
51 2021-02-16 weakness Dizziness and weakness
51 2021-02-16 numbness Throat began to feel like it was closing/difficulty swallowing, numbing on left side of tongue and j... Read more
Throat began to feel like it was closing/difficulty swallowing, numbing on left side of tongue and jaw and left side of nose. Bad headache. At 5:53pm still feeling numbness on tongue and roof of mouth, but otherwise symptoms of subsided. Called doctor, Took 2 Benedryl (25 mg capsules).
51 2021-02-16 tenderness, pain in extremity General soreness at the injection site for 48 hours. 4 days later left arm (injection) swelling of ... Read more
General soreness at the injection site for 48 hours. 4 days later left arm (injection) swelling of armpit lymph node. And later entire arm. Very painful, tender, sore and with restricted movement. Home medical visit Sat and Monday with Doctor. Ice/heat, liquids, Ibuprofen compression sleeve and elevation
51 2021-02-17 facial paralysis Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patien... Read more
Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patient). A 51-year-old female patient (Pregnant: No) received second dose of bnt162b2 (Lot number: EL9264), via an unspecified route of administration in left arm on 29Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN), collagen, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) and multi-vitamin. The patient previous received first dose of bnt162b2 (Lot number: EL0143), via an unspecified route of administration in left arm on 07Jan2021 14:00 for COVID-19 immunization. The patient experienced bell's palsy (hospitalization) on 30Jan2021 09:00. The patient was hospitalized for bell's palsy for 2 days. The patient was admitted on 30Jan2021 to hospital and diagnosed with Bell's Palsy. Treatment included: Prednisone and Valacyclovir. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. The outcome of event was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
51 2021-02-17 facial paralysis Bell's Palsy/right side of my face is completely paralyzed; This is a spontaneous report from a cont... Read more
Bell's Palsy/right side of my face is completely paralyzed; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283), via an unspecified route of administration on 21Jan2021 17:45 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products and patient was not pregnant. On 23Jan2021, the patient experienced Bell's Palsy about 48 hours after receiving the vaccine. The right side of her face was completely paralyzed. The patient was treated with prednisone and valacyclovir. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.
51 2021-02-17 flushing, numbness Left arm felt flush, arm turned reddish pink, left hand felt numb, arm became very warm to to the to... Read more
Left arm felt flush, arm turned reddish pink, left hand felt numb, arm became very warm to to the touch, left hand fingers became itchy. Kept in observation for a couple hours given Benadryl 25mg injection in right arm. Itching stopped. Under observation for additional 20 minutes after Benadryl. Arm was still pink and warm. Given instructions if reaction leaves localized area to go to ER and instructed to use ice pack on hand if itching begins again then sent home. 2/18/21 injection site tender to touch and warmer than other arm with no itching.
51 2021-02-17 flushing, tingling "Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual received the Pfizer Covid-19 vaccine at 7:00 pm. S... Read more
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual received the Pfizer Covid-19 vaccine at 7:00 pm. She began to feel flushed and tingling feeling to her hands and behind her ears. Individual was given Benadryl 50 mg IM. Individual was later discharge home with her husband at 7:55 pm. She appear to be stable and in no further distress.
51 2021-02-17 migraine Symptoms have not gone away. I still have (on and off) the back of my left shoulder up my neck into... Read more
Symptoms have not gone away. I still have (on and off) the back of my left shoulder up my neck into my jaw is where it's hurting. This usually comes with a migraine, but I don't have one today. It's just odd because I've never had this before, all the symptoms all at once. I've noticed under my left arm pit on occasions, sometimes when I'm laying at night feel swollen and in my groan as well. I have had some weird symptoms. I do get chills of and on but not at this very moment. My left ear has became hurting where the jaw pain is. I have to have my ears cleaned every so after so not sure if that has to do with my pain going on. I saw the ENT on December 30 and going to see them again on February 24th.
51 2021-02-17 pain in extremity A few hours after the vaccine I developed arm soreness, nausea and stomach pains as if I had did 100... Read more
A few hours after the vaccine I developed arm soreness, nausea and stomach pains as if I had did 100 situps which lasted about 24 hours but the arm soreness lasted about 3 days and afterward all symptoms subsided
51 2021-02-17 cold extremities Cold hands and feet; Chills; Back of the head aches; Stinging in injection arm; This is a spontaneou... Read more
Cold hands and feet; Chills; Back of the head aches; Stinging in injection arm; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 9265, expiry date: unknown), via an unspecified route of administration in the left arm, on 28Jan2021, at single dose, for covid-19 immunization, at an urgent care center. Medical history included known allergies to seafood. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included metformin, and hydrochlorothiazide, telmisartan. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced cold hands and feet, chills, back of the head aches and stinging in injection arm on 28Jan2021. No treatment was given for the events. The patient was recovering from the events. The events were assessed as non-serious.
51 2021-02-18 night sweats After first injection, did not feel good starting about 12 hours after the injection for about 24 ho... Read more
After first injection, did not feel good starting about 12 hours after the injection for about 24 hours of minor chills, aches, pains and headache. After second injection, did not feel good starting about 12 hours after injection for about 24 hours with full flu like symptoms, nausea, diarrhea, heavy chills, persistent headache, strong body aches, night sweats. After 24 hours, persistent neck, shoulder and arm aches and pain on the right side (same side as injection).
51 2021-02-19 difficulty speaking Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treate... Read more
Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treated with OTC Benedryl, Pepcid, and Zyrtec. Had a decrease in itching and mild improvement in the rash. At about 26 hours post-vaccination itching and severe hives developed a sought treatment in the emergency department for severe hives, severe itching, throat swelling, and hoarseness in voice. Was treated with solu-medrol, Pepcid, and Benedryl. Sent home with steroids and Benedryl. Then on 2/20/2021 began to develop throat swelling and voice hoarseness again. Sought the emergency room again for the same treatment list above.
51 2021-02-19 migraine, nerve pain Initially nerve pain from left neck to left fingers lasting 12 hours. Woke up with a migraine. Have ... Read more
Initially nerve pain from left neck to left fingers lasting 12 hours. Woke up with a migraine. Have had nearly daily headaches or migraines ever since. Previous to vaccination I would get one or two migraines per month. I also had joint pain in joints previously affected by Lyme disease 9 years ago that hadnt bothered me since being treated. That lasted about 6 weeks and has now finally subsided.
51 2021-02-21 weakness Flu-like. Headache, sweats/chills, fever (100.1), tired, body aches - for 2 days Body aches/tired ... Read more
Flu-like. Headache, sweats/chills, fever (100.1), tired, body aches - for 2 days Body aches/tired - continuing for 1 week Tired/low energy - for 2 weeks.
51 2021-02-21 discomfort Mild discomfort; This is a spontaneous report from a contactable consumer, the patient. A 51-years-o... Read more
Mild discomfort; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL-1283) , via an unspecified route of administration in the left arm (at 51 years of age) on 22-JAN-2021 at 13:00 as a single dose for Covid-19 Vaccination. Medical history included hypertension and Hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide, losartan potassium (HYZAAR). The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 22Jan2021 at 14:30, the patient experienced mild discomfort. No treatment was given for the event. The clinical outcome of the event mild discomfort was unknown.
51 2021-02-21 flushing The day after felt very fluish. Very fatigued and had swollen lymph node above right collar bone.
51 2021-02-21 mild one side paralysis, weakness Lightheaded, dizziness. Weakness on the side of the injection. No energy and shortness of breath wit... Read more
Lightheaded, dizziness. Weakness on the side of the injection. No energy and shortness of breath with activity ongoing. Patient normally very active and has not chronic conditions
51 2021-02-21 pain in extremity, migraine, numbness Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. Th... Read more
Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. They asked me what are my allergies and medical history. I couldn't remember - so had brain fog at that time. My left ear, face, and neck (left side of head) is numb at that time. The symptoms were the same for two hours. Memory remained fogged. An hour or so after the incident - I called the advice nurse from medical clinic and I did remember the doctor's name. Pain on head and numbness remained for days. My auto-immune system was stimulated my doctor said. Everything kept cascading down - now I'm on post surgery 9 days and I'm on disability. I went to ER on January 18, I was complaining of left sided numbness, vomiting, headaches. Facial numbness (left), mild headaches. Left sided headache progressed to (similar to prior migraine headaches) migraine like. January 29, I emailed my physicians (in between the 17th and 29th). On the 29th, I went to see the doctor - joints - really swollen and painful and I cannot walk. I was given steroid shots. February 2, - appt with neurologist. February - with Dr. - for painful swollen feet; Feb 10 - appt with Rheumotologist - Feb 10 with Dr - a Specialist - , as well. Right foot is swollen as well as the left foot at this time. Dr. - axperatated the right ankle -he said it was infected. February 11, Dr said I have infected joints and need surgery. They did surgery on February 13th. Dr. the surgeon . Had surgery at medical facility for infected ankle. February 15 - discharged home. Appt with surgeon on the 16th. Appt with Primary on the 19th. Appt with my Rheumotologist today. Discharged - with Home Health care; Physical and Occupational therapist and nursing. I have been on bedrest since discharge. I need maximum care. Tomorrow I have a appt with surgeon to hopefully remove cast and sutures on surgical site.
51 2021-02-21 tingling Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO wi... Read more
Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO with water, monitored closely for 1 hr. Instructed per Dr. not to have the second dose administered and to discuss with her physician. Symptoms subsided and pt sent home.
51 2021-02-22 flushing, feeling hot Left arm 1st dose given at 12:39 pm. 15 mins post vaccination, patient began having a warms sensatio... Read more
Left arm 1st dose given at 12:39 pm. 15 mins post vaccination, patient began having a warms sensation on her left shoulder blade followed by itching in her extremities. She was brought to observation and reported urticaria all over, flushing of the face, and hives in her upper and lower extremities. Vitals taken and were stable. Benadryl 50mg was administered 15 mins post vaccination and immediately patient reported decreasing symptoms of warmth sensation, itching, and hives. Patient reports she has recently developed hives with cortisone injections. Patient examined 20 mins post vaccination: S1,S2, CTA, hives noted on bilateral UE and LE. Hives resolved 25 mins post vaccination. Patient monitored for over 45mins and reported her symptoms were mild. She declined transportation to the ER. She left in stable condition with her husband.
51 2021-02-23 feeling hot Splitting headaches, extreme fatigue, nausea, feeling hot without fevers, joint and muscle aches.
51 2021-02-23 pain in extremity, tingling Developed shingles. One day after vaccine: fatigue, intermittent headache on one side of head, achy ... Read more
Developed shingles. One day after vaccine: fatigue, intermittent headache on one side of head, achy body, tingling sensitive scalp, stiff neck. Two days after vaccine: rash and swollen lymph nodes behind and in front of ear, in a line down neck, and at collarbone. Rash on one side of body only, in a band from the back of neck, across ear, down side of jaw and neck to collarbone. Slight pain and sensitivity in entire arm where I received the vaccine, which is the same side of body as rash. Three days after vaccine: rash continues, some blisters erupt. Four days after vaccine: rash is worse, tingling and burning, painful welts;visited clinic and diagnosed with shingles and prescribed topical medications.
51 2021-02-23 tingling Pt received dose #1 of Pfizer vaccine at 12:48 PM. After about 10-12 min wait period in waiting are... Read more
Pt received dose #1 of Pfizer vaccine at 12:48 PM. After about 10-12 min wait period in waiting area, c/o feeling "whoozy", a metallic taste in mouth and tingling of mouth. A short time later, reports that symptoms are worsening. Walked with stand by assist of two to cot. BP elevated, other VSS. C/o feeling "whoozy", middle tongue feeling swollen, metallic taste in mouth, mouth feeling numb/tingling. Symptoms progressed to rest of body feeling "tingling". Denies dizziness. Symptoms progressing. Denies SOB, itchy throat or throat swelling sensation. Denies any itching of skin. No hives or rash noted. Due to worsening of symptoms, a First Responder was called at 2:01 PM for transport, monitoring and treatment in ED.
51 2021-02-24 weakness 1 hour past 2nd shot, I felt fatigue, dizziness, brain fog and mild nausea. Possibly 12 hours past ... Read more
1 hour past 2nd shot, I felt fatigue, dizziness, brain fog and mild nausea. Possibly 12 hours past the shot, I awoke with a massive headache, achy joints & muscles from head to toe, chills, sweating, congestion, sore throat, increased dizziness and weakness. This was similar, but not as severe, as the onset of Covid-19 symptoms I experienced on January 5, 2021. 30 hours past the 2nd shot, I am still experiencing aches, pains, dizziness, fatigue, and a headache I cannot alleviate with Ibuprofen.
51 2021-02-24 hot flush First Fever, body aches, joint pain. Second Fever, head ache, body aches, joint pain, hot flashes an... Read more
First Fever, body aches, joint pain. Second Fever, head ache, body aches, joint pain, hot flashes and has missed work for 3 weeks.
51 2021-02-25 numbness, tingling About 15 min after administration, patient started c/o numbness/tingling in chin and lips. Patient w... Read more
About 15 min after administration, patient started c/o numbness/tingling in chin and lips. Patient was given oral diphenhydramine 50mg and notified EMS. When EMS arrived about 15 min later, patient initially declined to go to ER for eval. About another 15 min later, patient returned to clinic as face and chin were starting to swell slightly. Re-notifed EMS and the returned and picked up the patient. Patient left in awake condition, no respiratory distress.
51 2021-02-25 numbness had great amount of weakness to left leg that began evening of receiving vaccine dose. i also felt w... Read more
had great amount of weakness to left leg that began evening of receiving vaccine dose. i also felt weak, but left leg was extremely weak and just could not get much feeling in my leg.. also left foot numbness as well. headache increased over course of the evening and into the next morning. i alternated tylenol and advil to try and help with the headache beginning evening of receiving dose. by next morning i decided to take vicodin to help get the headache under control. i then began with vomiting late am on 2/06. had chills, headache continued, and headahce persisted. i also had very large amount of nausea that lasted until mid to late morning of 2/07. vomiting saturday am, afternoon, and evening. unable to keep any food or liquid down at all. swallowed 3 sips of gingerale saturday pm, and vomited within 5 minutes of it. feeling to my leg gradually returned to normal on saturday (vaccine was friday). i'm doing report mostly because of the left leg symptoms and vomiting. not sure if this should be reported, so i am just reporting it.
51 2021-02-25 pain in extremity Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea... Read more
Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea; Slight headache; Right arm injection muscular pain radiating to elbow; This is a spontaneous report from a contactable Nurse. This 51-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246), intramuscular at right arm on 25Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included HTN, cholesterol, known allergies: sulfa. Historical vaccine included the first dose of BNT162B2 (lot number=EJ1686) on 04Jan2021 13:00 via intramuscular at left arm for COVID-19 immunization. Concomitant medication included amlodipine, rosuvastatin calcium (CRESTOR), clonazepam. On 26Jan2021 12:00, patient had body aches, joint pains, chills, right arm injection muscular pain radiating to elbow, slight nausea, slight headache with outcome of unknown. No treatment was received. The patient underwent lab tests included COVID-19 virus test (nasal swab): negative on 10Jan2021. Patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination.
51 2021-02-26 flushing 20 minutes status post vaccination while sitting in the observation area the patient indicated to th... Read more
20 minutes status post vaccination while sitting in the observation area the patient indicated to the RN nurse observer that she "felt her face was flushed". Pt was seen and evaluated by NP, a redness was observed on patients bilateral cheeks and forehead. Pt was negative for chest pain, SOB, Facial Swelling, or N/V. There was no rash noted vital signs were taken, Patient was treated with 50mg of oral diphenhydramine, EMS was activated, pt was able to ambulate out of the vaccination center under the care of EMS and was transfered to the Hospital for further evaluation.
51 2021-02-26 tremor, feeling cold About 10 min after the in jection I started to feel nausea with a metal taste in my mouth. Then I st... Read more
About 10 min after the in jection I started to feel nausea with a metal taste in my mouth. Then I stared to get a headache and tremors in my hands and arms. After another 5 min I was getting mussel tightness in my face and throte. I started to get dizzy and feel very cold.
51 2021-02-27 flushing, feeling hot Headache -fatigue felt hot and flushed Body ache Chills Lasted 24 hours- came on evening after sh... Read more
Headache -fatigue felt hot and flushed Body ache Chills Lasted 24 hours- came on evening after shot
51 2021-02-27 tremor Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after... Read more
Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after injection; Fever of up to 102.5 starting 12 hrs after injection; Chills and shaking starting 12 hrs after injection; Very swollen and tender lymph node above clavicle noticed approximately 42 hours after injection; Muscle and joint pain
51 2021-02-28 facial pain ~approximately 30 min after vaccination received a funny feeling in my head not quite like a headach... Read more
~approximately 30 min after vaccination received a funny feeling in my head not quite like a headache and pain around my nose and between my eyes which lasted about 5 minutes followed by ear popping which ceased after about 5 minutes followed by ear pain for about 15 minutes
51 2021-02-28 facial pain 3 days of body pain; muscle aches all over body and face; muscle aches all over body and face; other... Read more
3 days of body pain; muscle aches all over body and face; muscle aches all over body and face; other vaccine same date; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on 22Jan2021 at 09:00 (at the age of 51-years-old) as a single dose in the left arm for COVID-19. The patient had no medical history. She was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not take any concomitant medications. The patient received another unspecified vaccine on 22Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously took penicillin from an unspecified date for an unspecified indication and experienced allergy. On 23Jan2021 at 06:00, the patient experienced 3 days of body pain and muscle aches all over body and face. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcome of 3 days of body pain and muscle aches all over body and face was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot number cannot be obtained.
51 2021-02-28 feeling cold, pain in extremity Side effects included chills for nearly 15 hours, extremely sore back, especially lower back, inject... Read more
Side effects included chills for nearly 15 hours, extremely sore back, especially lower back, injection site soreness of muscle area and back of legs were very sore. It was uncomfortable to walk. Could not get warm until I went to bed and wore fleece and used a down comforter and a fleece blanket. Laid on a heating pad to help ease the back pain. When I got up the following morning, all side effects were gone and nothing hurt. Also, I had Covid at the end of November, beginning of December 2020. I will not be getting the second vaccination - do not trust what is "not known". The side effects were worse than my experience with Covid.
51 2021-02-28 muscle spasms Within 15 minutes of shot, itching and muscle pain. Within 45 minutes of shot muscle cramping in ex... Read more
Within 15 minutes of shot, itching and muscle pain. Within 45 minutes of shot muscle cramping in extremities. Had taken 2 benadryl to ward off allergic reaction. That evening these symptoms continued and fatigue as well as low mood occurred. Next morning, right flank over the kidney pain-all day. Muscle pain- all day. Fatigued. Sunday, severe vertigo that lasted for several hours. Remitted for 5 hours and then returned. Dr. and Neurologist contacted.
51 2021-02-28 pain in extremity Woke morning after the shot with pain alone right side of the body from head to hip, worst in arm, ... Read more
Woke morning after the shot with pain alone right side of the body from head to hip, worst in arm, low grade fever and earache right side only.
51 2021-02-28 pain in extremity Vaccination given in the joint of Left shoulder (Top of shoulder). Not Deltoid Muscle as recorded.... Read more
Vaccination given in the joint of Left shoulder (Top of shoulder). Not Deltoid Muscle as recorded. Although I did not see the location of the vaccination given at that time, the location of the bandage indicated site of vaccination given. Pain in Left arm was excruciating for 3 days. Ice packs and Tylenol was taken but did not help. Pain continues since vaccination was given. Spoke to nurses and physicians since the incident occurred, and all sources has stated that vaccination should not have been given in the joint but in the muscle. I am reporting this so nurse can be corrected so that she does not cause unnecessary pain and trauma to other people.
51 2021-02-28 pain in extremity Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Numb... Read more
Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Number 2, Date of start of drug 21Jan2021/ Dose Number 1, Date of start of drug 29Dec2020; This is a spontaneous report from a contactable nurse (patient). A 51-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on the left arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no allergies to medications, food, or other products. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: unknown) in the left arm on 29Dec2020 at 15:00 (3:00PM) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021 at 04:00, the patient experienced stomach cramps and arm soreness for two days. On the same day, the patient experienced severe vertigo with nausea and was unable to get up or walk. The following day, 24Jan2021, vertigo was slightly less. On the fifth day, the patient was still having some dizziness and nausea. No treatment was administered for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The events stomach cramps and arm soreness resolved in 25Jan2021, and the events nausea, unable to get up or walk and dizziness had not resolved, while the event severe vertigo was resolving.
51 2021-03-01 feeling hot treatment - benadryl, hydration, rest, monitoring vitals at home
51 2021-03-01 hot flush, feeling cold Fever chills fatigue and ongoing hot flashes and cold spells where I cannot get warm. Temperature sw... Read more
Fever chills fatigue and ongoing hot flashes and cold spells where I cannot get warm. Temperature swings are terrible for over 3 weeks since the second vaccine
51 2021-03-02 burning sensation After the first dose for the Pfizer, I experienced a metal like taste in mouth, shortly after. Howev... Read more
After the first dose for the Pfizer, I experienced a metal like taste in mouth, shortly after. However, that went away within an hour. I had the typical low side effects of localized injection soreness, swelling, redness, warmth feeling and it was red around the injection site. The following two days after vaccination (2/22/21) I experienced the expected low side effects. On the third day after vaccination, I was feeling well again. However, yesterday 3/2/21, I noticed the area where I received the Covid vaccine was red again, with itching, warmth feeling, redness, and a bit of burning sensation. This is only apparent on the injection site. I contacted the CDC today, 3/3/21 and they directed me to you to report this and also to contact my healthcare provider, which I have. The CDC was not able to tell me if it was considered normal to have the localized injection site side effects resurface again a week after receiving the 1st dose vaccine. Therefore, I was advised by the CDC to report it. It is also unclear to me if the reason for the localized injection site side-effects being more prominent because of where the injection was administered. There is a question about it having been administered closer to subcutaneously by the nurse than intramuscular, but I do not know.
51 2021-03-02 discomfort Nausea vomiting diarrhea severe headache unable to eat so far for 3 Days cannot lift my head fever c... Read more
Nausea vomiting diarrhea severe headache unable to eat so far for 3 Days cannot lift my head fever chills. Severe internal ear pain and headache but it's not touched by Tylenol or Ibuprofen
51 2021-03-02 hot flush, feeling cold low grade fever 101 highest; hot/cold flashes; hot/cold flashes; exhausted; overall body achy; sore ... Read more
low grade fever 101 highest; hot/cold flashes; hot/cold flashes; exhausted; overall body achy; sore arm at/around injection site; This is a spontaneous report from a contactable consumer. A 51-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EN 5318), via an unspecified route of administration at Left arm on 16Feb2021 08:45 at single dose for covid-19 immunisation. The patient medical history was not reported. Allergies to medications, food, or other products: none. Prior to vaccination, was the patient was not diagnosed with COVID-19. Concomitant medication included naproxen sodium (ALEVE) and multi vitamins. The patient previously received first dose of bnt162b2 on 26Jan2021 for covid-19 immunisation. The patient experienced low grade fever 101 highest, hot/cold flashes, exhausted, overall body achy, sore arm at/around injection site on 16Feb2021 12:30. No treatment received for the events. Outcome of events was recovering.
51 2021-03-02 migraine In the early evening after my second Covid vaccine I began to have moderate body aches, fatigue, inj... Read more
In the early evening after my second Covid vaccine I began to have moderate body aches, fatigue, injection site swelling and headaches. Some of my headaches developed into migraines. The body aches lasted about 14 hours but the headaches persisted for almost two weeks before resolving.
51 2021-03-02 pain in extremity just a sore arm starting approx 6 hours after injection; This is a spontaneous report from a contact... Read more
just a sore arm starting approx 6 hours after injection; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3249; expiration date: unknown) at vaccination age of 51-year-old intramuscular in the right arm on 15Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included high blood pressure, and allergies to penicillin and sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included unspecified medication. The patient received her most recent COVID-19 in a public health clinic/veterans administration facility. The patient reported that she did no adverse events, she was just a sore arm starting approximately 6 hours after injection (15Jan2021) and lasting about 24 hours (16Jan2021). The event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on 16Jan2021. No follow up attempts are possible. Information about lot/batch number cannot be obtained.
51 2021-03-02 pain in extremity Fever over 100; headache; chills; joint soreness; arm soreness; This is a spontaneous report from a ... Read more
Fever over 100; headache; chills; joint soreness; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264, expiration date was not reported), via an unspecified route of administration on the left arm on 30Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included Sulfa allergy, penicillin allergy, COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included estradiol. The patient experienced fever over 100, headache, chills, joint soreness and arm soreness on 31Jan2021 at 04:00 am. No treatment was given in response to the events. Outcome of the events was unknown.
51 2021-03-02 pain in extremity I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administratio... Read more
I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; left arm soreness onset evening of vaccine for about 1.5 days; This is a spontaneous report from a contactable nurse (also the patient). A 51-year-old female (also the age at vaccination) patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration at the left arm on 07Jan2021 14:40 (also reported as 02:45 PM) at SINGLE DOSE for Covid-19 immunization. The patient was vaccinated at a Hospital. The patient is not pregnant at the time of the report. Medical history included Environmental allergies: some trees and grass (also reported as Known allergies: No). The patient had no COVID prior to vaccination. Th patient was not COVID tested post vaccination. No other vaccine in four weeks. Concomitant medication included (reported as Other medications in two weeks) bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL), vitamin d nos (VITAMIN D NOS) and MVM (exact meaning unspecified). It was reported that: "Administration time on my paperwork was documented incorrectly; I received 07Jan2021 dose at 2:40pm and not the 1:40pm time that is documented. I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration (reported as 5:30 PM), lasting about 2 hours and resolved; left arm soreness onset evening of vaccine for about 1.5 days." The patient was not treated for the events. The outcome of the events was recovered.
51 2021-03-02 pain in extremity Left arm soreness; This is a spontaneous report from a contactable nurse (reporting for herself). A ... Read more
Left arm soreness; This is a spontaneous report from a contactable nurse (reporting for herself). A 51-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration from 28Jan2021 14:45 to 28Jan2021 14:45 at SINGLE DOSE for covid-19 immunization. The patient's medical history included Environmental allergies: some trees and grass. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL), colecalciferol (VITAMIN D [COLECALCIFEROL]), all for unspecified indication. The previously took her first dose of bnt162b2 on 07Jan2021 (lot number: EL3248) on her left arm for covid-19 immunization. On 28Jan2021 at 17:30, the patient experienced Left arm soreness beginning a few hours after vaccine administration and lasting about another 24 hours. The outcome of the event was recovered on an unspecified date. The seriousness of the event was reported as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
51 2021-03-03 numbness, weakness Feeling of weakness, numbness around fingers and mouth, nausea.
51 2021-03-03 migraine Would consider myself someone extremely healthy without any disease. My symptoms included intermitte... Read more
Would consider myself someone extremely healthy without any disease. My symptoms included intermittent migraines with rainbow halo around lights for two weeks, myalgia that I have never experienced. Vaginal breakthrough bleeding with period ( have IUD placement x2 years and haven't had bleeding since). In addition I experienced the normal fever, malaise and fatigue for the first three days following but wanted to report the extended symptoms that continued. Feel great now and am thankful, but thought it would be useful for research purpose.
51 2021-03-03 migraine See previous answers.
51 2021-03-03 migraine Migraine, vomiting, intense injection arm pain ( unable to lift arm), joint pain, diarrhea
51 2021-03-03 nerve pain, pain in extremity, numbness Numbness in fingers and hands, arms, legs, and feet. Right leg swollen. Knee 3 times the regular siz... Read more
Numbness in fingers and hands, arms, legs, and feet. Right leg swollen. Knee 3 times the regular size. Throbbing in feet and swollen, stiffness can't hardly bend right knee. Made my neuropathy worse. Head aches more, blurry vision, light sensitive, body aches, backache, coughing.
51 2021-03-03 pain in extremity lower back pain, fatigue, flu-like symptoms, arm pain
51 2021-03-04 pain in extremity Sore arm, temp 99.9, headache, fatigue, dizzy, HTN, sweats, chest pain
51 2021-03-04 seizure, severe one side paralysis Loss of failing left side stroke like symptoms with seizures
51 2021-03-04 tremor Patient received vaccine, reports that she had "chills, shakey, trembling, difficulty thinking, brea... Read more
Patient received vaccine, reports that she had "chills, shakey, trembling, difficulty thinking, breathing fast"
51 2021-03-05 bell's palsy On March 4 the patient noticed the L side of her face sagging and thought it might be a stroke. She ... Read more
On March 4 the patient noticed the L side of her face sagging and thought it might be a stroke. She went to Urgent Care and was diagnosed with Bell's Palsy. She is currently being treated with Prednisone 60mg/day and Valcyclovir 1gr tid. She returned to the Vaccine POD with parents to inquire about the next vaccine. She has a neurologist whom she will see and discuss the issue
51 2021-03-05 feeling hot, cold sweat Patient slowly lost consciousness and dropped out of her chair to the floor. She appeared clammy and... Read more
Patient slowly lost consciousness and dropped out of her chair to the floor. She appeared clammy and was not responsive for about a minute. After that time, the patient came back to consciousness and was able to articulate her symptoms, She felt warm for a few minutes and was brought an ice pack to cool down.
51 2021-03-06 flushing Once I sat down about 4 minutes after the shot my heart started racing very rapidly. I became very ... Read more
Once I sat down about 4 minutes after the shot my heart started racing very rapidly. I became very light headed and my face was flushed. It took about 10 minutes of trying to force myself from panicking ( I do not get panic attacks). There were too many other people in the waiting room so I didn't feel like I could discretely tell the nurse about my reaction. I felt light headed the rest of the day. About 5 days later, I was sitting in the chair at my salon and it happened again. Racing heart rate and all the same cardiac symptoms as before. I do not have high blood pressure or any cardiac illness. I also had a heaviness, congested feeling in my chest for about 2 weeks. I had another issue with very rapid heart rate for most of the day over the last two days.
51 2021-03-06 tingling tingling on hands/feet/arms/legs for the past 7 days(everyday, all days) after 4th day from the ino... Read more
tingling on hands/feet/arms/legs for the past 7 days(everyday, all days) after 4th day from the inoculated date
51 2021-03-07 concussion I felt fine after the vaccine. That night, I had a sore injection site, but no other symptoms. I wok... Read more
I felt fine after the vaccine. That night, I had a sore injection site, but no other symptoms. I woke up at 1:15 a.m., felt okay, walked to the bathroom, and suddenly felt extremely nauseous and thought I might vomit. After walking a few steps, I fainted unexpectedly and got a concussion from the fall. Note: I had hit my head earlier that day on something while standing up, but that had not caused any symptoms.
51 2021-03-07 feeling cold, night sweats dizzy; nauseous; sweating and sweated all night; fever of 99; achy; feeling cold/freezing; chills; T... Read more
dizzy; nauseous; sweating and sweated all night; fever of 99; achy; feeling cold/freezing; chills; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 51-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration on the left arm, on 03Feb2021 15:00, at single dose, for covid-19 immunization. Medical history included high blood pressure and, diagnosed with COVID-19. The patient has unspecified concomitant medications. The vaccine was received at the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 04Feb2021 around 12NN, the patient started feeling cold and chills. By 17:00 on 04Feb2021, she had fever of 99 and was freezing and achy. Around 20:00 on 04Feb2021, she started sweating and sweated all night. She felt better on 05Feb2021 around 14:00. On 06Feb2021 she got up, and then was dizzy and nauseous. At the time of the report, the patient was recovering from all the adverse events with no treatment received. The patient has not been tested for COVID-19 since the vaccination.
51 2021-03-07 tingling, numbness I stayed 30 min after injection because I receive allergy shots. (Grass, pollen, dust, mold) approxi... Read more
I stayed 30 min after injection because I receive allergy shots. (Grass, pollen, dust, mold) approximately 10-15 min after leaving I experienced numbness/tingling on the right side of my face. It lasted approximately 1 hr I would say.
51 2021-03-07 tremor Very sudden on set extremely bad headache and shaking.
51 2021-03-08 difficulty speaking Approximately 5 hours after the second shot (EN6205) on March 5, 2021, I experienced full body aches... Read more
Approximately 5 hours after the second shot (EN6205) on March 5, 2021, I experienced full body aches, slight tingling on the tongue, and eventual loss of voice over the subsequent two days. The on duty nurse who had administered the shot, strongly suggest that I drink lots of water and take Tylenol. March 6 and 7, my voice was to a whisper; however, the body aches and tingling of the tongue had subsided. I was extremely exhausted and unable to speak above a whisper on March 8, but did not experience any of the aforementioned side affects. Today, March 9, my voice is back above a whisper, with intermittent hoarseness. I will continue regiments of rest, Tylenol, hot tea with crushed ginger. It is important to note that my breathing had not been affected since having taken the 2nd shot on March 5, 2021.
51 2021-03-08 feeling hot Patient felt hot once sat down at bleachers, became sweaty and queasy. 15 minutes passed. Patient fe... Read more
Patient felt hot once sat down at bleachers, became sweaty and queasy. 15 minutes passed. Patient felt better then stood up and became hot and queasy again.
51 2021-03-08 feeling jittery The patient reports nausea and vomiting with a jittery feeling. Patients B/P was 132/73, HR was 83,... Read more
The patient reports nausea and vomiting with a jittery feeling. Patients B/P was 132/73, HR was 83, RR WAS 18. Patient denies any difficulty breathing. The patient is awake and alert with no apparent distress.
51 2021-03-08 flushing flushing, lip numbness/tingling, lightheaded, HA. Evaluated by EMS-Cleared
51 2021-03-08 numbness Nausea, oral tingling, dizziness, leg/oral numbness. Evaluated by EMS-Transported to Emergency room/... Read more
Nausea, oral tingling, dizziness, leg/oral numbness. Evaluated by EMS-Transported to Emergency room/department or urgent care.
51 2021-03-08 muscle spasms, weakness first night had strange vivid dreams, extremely fatigued/sleepy, muscle aces all over, joint pains a... Read more
first night had strange vivid dreams, extremely fatigued/sleepy, muscle aces all over, joint pains all over (arthritis is only in a few joints), runny nose, sore throat. 2nd day felt better but still very sleepy, fatigued, muscle cramping. 3rd day still extremely sleepy, muscle soreness, joint pain. 4th day fatigue, weakness, nausea.
51 2021-03-09 numbness Itching began on 3/6, followed by pustules extending from left shoulder to elbow. Pustules started s... Read more
Itching began on 3/6, followed by pustules extending from left shoulder to elbow. Pustules started small and are now much larger. Right sided facial numbness.
51 2021-03-09 pain in extremity, cold sweat, feeling of body temperature change, tremor Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with... Read more
Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with being tired then led to extreme exhaustion and lethargy and loss of taste (salty and sweet), but had an appetite and drank a LOT of water, taking Tylenol around 6 pm; slept restless and in pain with fever and feeling both burning up and freezing cold with clammy chills. Couldn't settle. Approximately 3:30 am, had diarrhea until I had nothing in my system and developed uncontrollable shaking. Finally got some sleep after a hot bath. The next day, no appetite, drank little water and kombucha to settle my stomach, exhausted, feverish, napped off and on all day, right arm began hurting tremendously and right side including jaw and tongue felt swollen, took Tylenol in the morning and BC Powder pm before bed. Slept moderately well. Monday, napped off and on but started feeling better with only moderate exhaustion around 6 pm, but right arm was in pain. Tuesday, moderate exhaustion, had to nap for 2 hours mid-day, right side of body including tongue was swollen, arm in pain and entire upper arm muscle felt knotted. Went for a massage and worked out knot quite painfully. Today, moderate to mild exhaustion, upper right arm a bit sore, semi- decent appetite.
51 2021-03-09 pain in extremity, numbness left arm soreness - like inside, like the bones are dying or festering - very hard to describe (at l... Read more
left arm soreness - like inside, like the bones are dying or festering - very hard to describe (at least 21 days as it's never changed nor gone away since starting the day of the injection); whole body joint pain for at least 3 full days (couldn't walk at normal pace or grip chopsticks etc), fatigue for maybe 6/7 days (in bed 10-14 hours barely able to move, but awake and alert so not sleepy per se), muscle numbness in left arm for 2 days.
51 2021-03-09 pain in extremity One hour and 15 min after the shot extreme fatigue began. Also my Left Arm was hurting. Then when I ... Read more
One hour and 15 min after the shot extreme fatigue began. Also my Left Arm was hurting. Then when I got in bed at 10pm, all of my muscles began hurting really badly, and I was awake most of the night, feeling sick with nausea, dry mouth, and pain all over. The next day I felt really wrecked, way worse than my usual Fibromyalgia/Anxiety symptoms. My body really hurt all over and I was really fatigued. I felt general malaise all day long and my left arm hurt a lot. That second night I slept better and the next day I was better except my left arm was still sore that day also.
51 2021-03-09 pain in extremity 1st day just sore arm. 2nd day just felt off, 3rd day mild headache chills, 4th day sever headache, ... Read more
1st day just sore arm. 2nd day just felt off, 3rd day mild headache chills, 4th day sever headache, vomitting, nausea, stiff neck and shoulders.
51 2021-03-09 tingling, numbness Left side facial numbness ,tingling and discomfort also feeling woozy
51 2021-03-10 breast pain Fatigue and breast soreness
51 2021-03-10 breast pain "I had to go to the doctor office due to sensitivity, soreness in the right armpit and tenderness in... Read more
"I had to go to the doctor office due to sensitivity, soreness in the right armpit and tenderness in both breasts after receiving the first shot. This occurred approximately 3 days after the first inoculation and continued for 10+ days with the breast tenderness continuing to be an issue. The second shot was extreme fatigue for 2 days, and the continuing breast soreness."
51 2021-03-10 flushing Pt was given Pfizer COVID-19 vaccine #1 at approx. 0830. Shortly after pt experienced flushing, shor... Read more
Pt was given Pfizer COVID-19 vaccine #1 at approx. 0830. Shortly after pt experienced flushing, shortness of breath, and chest tightness. Pt was given benadryl and EpiPen at approx. 0930. Pt was referred to Hospital ER where she is presently being monitored.
51 2021-03-10 numbness At 1615 Patient reported symptoms after coivd19 vaccine Pfizer 2nd dose. With left arm rash, warm to... Read more
At 1615 Patient reported symptoms after coivd19 vaccine Pfizer 2nd dose. With left arm rash, warm to touch and numbness. Same symptoms were reported by patient after receiving the first dose coivd19 vaccine Pfizer. Adverse reactions were reported to Dr. and RN. for further medical intervention As per Dr. orders, Benadryl 25 mg IM.
51 2021-03-11 bell's palsy Bell's palsy of right face - slight symptoms occurring 2 days after vaccination and worsened until n... Read more
Bell's palsy of right face - slight symptoms occurring 2 days after vaccination and worsened until noticed and taken to local ED 5 days after vaccination.
51 2021-03-11 tingling Patient came in for first COVID vaccine. Given at 0942 on left deltoid. At 0957, patient complaint o... Read more
Patient came in for first COVID vaccine. Given at 0942 on left deltoid. At 0957, patient complaint of having a headache and tingling to her body. Headache pain at 4/10. Denied any dizziness. Was awake, alert and oriented.
51 2021-03-12 feeling cold At 8pm 3/11/21 I was very tired and cold. (different than chills from a fever). Did not feel feveris... Read more
At 8pm 3/11/21 I was very tired and cold. (different than chills from a fever). Did not feel feverish. At 4am 3/12/21 I woke up with severe muscular pain in my entire body and severe head pain. I took 2 Advil and went back to sleep. Woke up at 8:00am 3/12/21 with severe back ache and headache. Took 3 Advil and pain subsided over the next 3 hours. Did not have to redose Advil.
51 2021-03-12 flushing Patient received vaccine and1 minute after patient had a warm flushing sensation that she described ... Read more
Patient received vaccine and1 minute after patient had a warm flushing sensation that she described as being similar to getting contrast. She stated that the back of her throat was warm and the tip of her tongue as well, she was remvoed from the cell and brought to the observation area, her blood pressure was 173/87, heart rate 109, pulse ox 98 in the L arm. She was observed and follow up at 0906 was 174/96, pulse 99 and pulse ox 100. She was observed for another minutes and at 0920 in the R arm her blood pressure was 152/ 85 and heart rate 101. She stated that the warm feeling was resolving and that her tongue still felt a little warm. She did have reddened arms as well in her bilateral arms, no other skin changes noted.
51 2021-03-12 flushing Elevated HR, Flushing. Evaluated by EMS-Cleared
51 2021-03-13 inability to speak, pain in extremity Im not sure if this is an adverse effect - But here are the sxs I felt - after my shot - when i was ... Read more
Im not sure if this is an adverse effect - But here are the sxs I felt - after my shot - when i was sitting in the waiting area for the mandatory waiting period of 15 or so minutes - I felt a slight pain in my left arm, a slight pain in my left chest area, and a slight pain in my left back area. I came home and felt a brain fog. I was forgetful, and very slow, I could feel a part of me being acutely aware that I was struggling to process information that I processed before normally. I was very irritable more so than I have experienced before, and that lasted approximately days till March 17th. The brain fog dissipated slowly over 24 hrs, Blood Pressure on March 11th ( fourth day) was 143/80 - 69 beats per minute at 6:15 pm and 155/88 - 75 BPM at 8:14 pm. Blood pressure reading on March 12th 155/105 - 71 bpm at 5:31 pm. and 142/98 - 80 BPM at noon . The pain in the chest and arm area existed, for a few more days and is intermittent in the last few days. Today 3/13/21 i felt it when i was bending to push and pushing potted plants around. But that was the only time. Today's BP reading was 139/85 - 88 BPM at 6:15 pm. I am concerned if I should take the second dose or not. If this is normal and Im ok to take the second dose please email me either way. I just want to ensure that this is not an adverse cardiological side effect and wanted to check in . Thankyou
51 2021-03-14 burning sensation, migraine Extreme Headache, Rash on lower portion of both arms, felt like my skin was on fire from the inside ... Read more
Extreme Headache, Rash on lower portion of both arms, felt like my skin was on fire from the inside out on my face, neck and arms, extreme fatigue, chills. Lasted for a week. Longer Effects, extreme fatigue and brain fogginess ( it's now March 15th, I am still having these effects)
51 2021-03-14 flushing, tremor Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
51 2021-03-14 muscle spasms Frequent bowel movements 24hrs, ear popping and pain 24 hrs, weird head feeling (not a headache) 48 ... Read more
Frequent bowel movements 24hrs, ear popping and pain 24 hrs, weird head feeling (not a headache) 48 hrs, leg cramps began maybe a couple of days later and still continue over a month later, high fever lasting 3 days
51 2021-03-14 pain in extremity Fatigue, headache, and soreness in the arm, back, and leg shortly after administration of vaccine
51 2021-03-14 pain in extremity swollen lymph node under left arm causing pain; swollen lymph node under left arm causing pain; This... Read more
swollen lymph node under left arm causing pain; swollen lymph node under left arm causing pain; This is a spontaneous report from a contactable consumer reported for herself that a 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 51-years via an unspecified route of administration in left arm on 24Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure; fibromyalgia; kidney stones. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included paracetamol (TYLENOL ARTHRITIS); enalapril; amlodipine; hydrochl (as reported). The patient historically received first single dose of BNT162B2 at the age of 51-years via an unspecified route of administration in left arm on 03Feb2021 03:00 PM for COVID-19 immunization. On 26Feb2021 06:00 AM, the patient experienced swollen lymph node under left arm causing pain. It was unknown if treatment was received for the adverse events. The events result in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
51 2021-03-14 pain in extremity After the first 24 hrs, arm was sore for 48 hours, score of a 7
51 2021-03-14 tingling 10-hours after vaccination, I experienced an inability to swallow, tingling sensation in face; lips... Read more
10-hours after vaccination, I experienced an inability to swallow, tingling sensation in face; lips began to feel swollen, chills. Took a Zyrtec and symptoms went away within an hour.
51 2021-03-15 weakness Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5... Read more
Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5 -10 minutes resolved . Weakness within 20 minutes and dizziness later that night into next day . Itchy injection site at night .
51 2021-03-15 burning sensation 3 Hours after vaccination, I experienced swelling around my Left ear and Left Lower Jaw with a burni... Read more
3 Hours after vaccination, I experienced swelling around my Left ear and Left Lower Jaw with a burning sensation. The burning stopped with the fir dose of Benadryl 25mg (which I took every 8 hours for 3 additional doses) The swelling eventually decreased after 3-4 days.
51 2021-03-15 hot flush After vaccine on 2/25/2021 had standard chills, aching lasting 2 days. 2 days after vaccination st... Read more
After vaccine on 2/25/2021 had standard chills, aching lasting 2 days. 2 days after vaccination started to develop pimples to chin (painful) and hot flashes which were intense but have since decreased in severity.
51 2021-03-15 numbness, tingling about 45 min after shot, face began tingling and then felt numb. numbness continued for about 24 hou... Read more
about 45 min after shot, face began tingling and then felt numb. numbness continued for about 24 hoursn
51 2021-03-15 numbness, tingling Face became numb and tingling. It lasted about an hour then went away on it's own
51 2021-03-15 pain in extremity At the time of my vaccine, the nurse asked me if I experienced any pain at the site and happened to ... Read more
At the time of my vaccine, the nurse asked me if I experienced any pain at the site and happened to mention that the needle being used did not retract from my arm. I did not experience any pain in that moment. Later in the evening, I begun to experience muscle pain at the site of the vaccination but believed it was due to the shot. It has now been about a week and a half and pain is now in my shoulder and has traveled down my arm.
51 2021-03-15 tingling Patient complains of Lt. hand tingling after the vaccination. it was resolved after 20mins. pt. le... Read more
Patient complains of Lt. hand tingling after the vaccination. it was resolved after 20mins. pt. left and went home.
51 2021-03-15 tingling Patient complained of chest pain radiating to her L shoulder starting at 1620. Patient moved to den... Read more
Patient complained of chest pain radiating to her L shoulder starting at 1620. Patient moved to dental chair, Dr called and vitals taken at 16:30 was O2 92%, BP 142/91. 16:38 pt complains of slightly improved CP and but tingling in both arms and hands, O2 remains 92-98%. EMS called at 16:40. Aspirin 325mg chewed given 16:50. Pt declined ambulance ride to ER but agrees to go to ER with daughter immediately for further assessment.
51 2021-03-16 weakness, migraine Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6... Read more
Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6:30pm I began to feel extremely wired and like my body would jump through my skin. I tried to relax and started feeling sick at the stomach. I went to bed early. 3/12/21 at 6:15am I was awakened with heart racing extremely fast and migraine starting at base of back of head. I could not get my heart to slow down. My husband called 911. Paramedics came and my blood pressure was 163/116 and heart rate 85. 10 minutes later it was 157/84 and heart rate 64. (The day before vaccination my cardiologist recorded my blood pressure at 110/52 and it has always run low. ) I had no energy nor appetite and slept most of the day 3/12/21 through 3/12/14. Still feeling extremely fatigue and ears ringing and can hear heart beating in ears.
51 2021-03-16 feeling hot After injection, immediately felt warm squeezy feeling and pain going up to my neck and going to my ... Read more
After injection, immediately felt warm squeezy feeling and pain going up to my neck and going to my head and giving me a headache. It eased up. About an hour later, I was getting itchy - arms; legs. Big welts on arms and legs and one my back. I took Benadryl hoping it would go away - took it for three days. It wasn't going away. I would scratch and every time I would scratch then hives would spread throughout the whole area that I scratched. Called my Dr's office - he told me to take Benadryl. By Saturday, I went to clinic. Was given steroid pills and prescription for Claritin or Zyrtec. No testing. The meds helped with the smaller hives but my welts still remained and by rubbing the welts I would still get hives around it and they get re-inflamed and they swell up - even it it's my clothes that rub against it. Still have dry patches but they are a little raised but as much as before. I was told to put some cortisone cream on them to help them go away. I was advised not to get second shot.
51 2021-03-16 flushing Pt in COVID-19 observation area complained of loosing strength to arms and legs and flushed color. ... Read more
Pt in COVID-19 observation area complained of loosing strength to arms and legs and flushed color. Warm and dry to touch. B/P @ 182/62 HR-121 Alert and oriented. Code Assist called. Pt was given Benadryl 25mg IM by Code Assist Team. Pt was taken to Adult W.I. Clinic to Continue of care.
51 2021-03-16 migraine The following is the timeline of progression: First 48 hours: Immediately following the vaccine I fe... Read more
The following is the timeline of progression: First 48 hours: Immediately following the vaccine I felt I would vomit. That lasted 2 hours. The remainder of the 48 hours I had a growing headache that turned into a migraine level. Cognitively my husband would say I was out of it, not able to focus. The area around my eyes – my eyelids and below eyelids bright red – like I had put a bright red blush on them. Three to four days later: Saturday night my symptoms started to progress over a span of a few hours very drastically. I had symptoms of Diarrhea– crazy impact in my gut. Sunday I still had migraine level pain in a headache. I felt increased symptoms of nausea and diarrhea increased. Sunday I still had migraine level pain in a headache. I felt increased symptoms of nausea and diarrhea increased. By Sunday afternoon I had full blown symptoms of stomach flu. I had chills, extreme nausea that became debilitating. We do not have a thermometer that works, as a result I do not know if I had a fever. By Sunday night I was vomiting and symptoms progressed to tightness of chest, shortness of breath, vomiting, diarrhea, chills. My gut was literally moving in sharp pain, sounds, and cramping. It was severe diarrhea. I was achy and tired, but could not fall asleep due to nausea and vomiting. I was unable to stand up without the fear of passing out. I tried to manage the nausea with medicine that I have at home. It assisted but did not ultimate make an impact. By 4:30 a.m. I was scared by the lack of breath and asked my husband to call 911. The paramedic stated that I had an increased heart rate, but good blood pressure. I went to the hospital and received fluids, two different additional doses of nausea medicine, oxygen and a gut muscle relaxer. After 30 to 40 minutes I showed improvement and was able to go home. Still had pink color tone in skin around my eyes. On that Monday (2/8/2021), I was unable to go to work and called in for Covid PTO. I slept most of the day. Five days later: Still have a headache that can be managed with Tylenol. I still have diarrhea. I no longer have nausea, the pink color around my eyes seems to be gone.The nurse team and ambulance team all stated that the second shot was awful. Three folks stated they were in fetal position for two days. I was not able to ask what that meant due to my extreme nausea and trying to not dry heave. Note: I did not have any symptoms from the first vaccine – just a dull headache.
51 2021-03-16 migraine 1/8-1/10/2021: prolong fever 102 1/8: vomiting 1/11-1/13: temp 101 to 99.9 1/8-1/16: headaches /mi... Read more
1/8-1/10/2021: prolong fever 102 1/8: vomiting 1/11-1/13: temp 101 to 99.9 1/8-1/16: headaches /migraines w/ double vision 1/11-1/16: thrush ,open fever blisters lips and mouth,+ swollen mouth, lips, tongue Treated at home w/ Tylenol q4,fluids, benadryal ,salt water mouth rinse. ice pack. Subsided 1/16/2021 . healthy prior to second vaccination
51 2021-03-17 numbness when I first got it I remembered I felt off and a little dizzy so I laid down and my BP was high ab... Read more
when I first got it I remembered I felt off and a little dizzy so I laid down and my BP was high about 15 mins after, my right side of face and arm went numb, that went away but that night I had body aches headache fever chills and fatigued which was out of the ordinary for me. About two weeks later I tested positive for Covid. I'm still dealing with covid related symptoms but I don't think that was from the vaccine
51 2021-03-17 pain in extremity, weakness headache @1:30pm pain left arm @ 8pm body aches9:20pm nausea10pm an urgency to move bowels 10:30pm... Read more
headache @1:30pm pain left arm @ 8pm body aches9:20pm nausea10pm an urgency to move bowels 10:30pm ( relieved after bowel movement @7am) chills10:30pm sweating10:30p loss of strength/ lack of energy/ weak 11pm muscle aches 11pm slight confusion 1:30am joint (wrists and ankle) 7am all previous symptoms exists into next day 3/18 except the confusion motion appears to relieve the body aches
51 2021-03-17 tingling Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: , MD at 3/18/2021 7:58... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: , MD at 3/18/2021 7:58 AM Expand AllCollapse All COVID VACCINE CLINIC 66612 3/17/2021 Patient: Date: 3/17/2021 Subjective is a 51 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience dizziness and nausea and tingling down left arm where she got her shot. . She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency . Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of frequent throat clearing, vomiting (nausea), muscle aches (left arm), dizziness and headaches CONT negative Eyes negative Respiratory negative Skin negative Previous Reactions: Nausea with first Covid shot Objective Vitals Vitals: 03/17/21 0140 03/17/21 1332 03/17/21 1407 BP: 134/82 (!) 144/87 135/74 Pulse: 93 89 SpO2: 97% Physical Exam Constitutional: Appearance: Normal appearance. She is well-developed. HENT: Head: Normocephalic. Jaw: There is normal jaw occlusion. Right Ear: Hearing normal. Left Ear: Hearing normal. Nose: Nose normal. Mouth/Throat: Lips: Pink. Mouth: Mucous membranes are moist. No angioedema. Pharynx: Oropharynx is clear. Eyes: General: Gaze aligned appropriately. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: Cervical back: Full passive range of motion without pain. Neurological: Mental Status: She is alert. Psychiatric: Behavior: Behavior is cooperative. Assessment/Plan Treatment included: water and pepcid, zofran and Ibuprofen Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Released to go home with sister. No driving tonight. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) 2:30 pm Electronically Signed 3/17/2021 2:30 PM
51 2021-03-18 weakness Myalgia, Arthralgia, chills and weakness Narrative: Other Relevant History:
51 2021-03-18 flushing, tingling, burning sensation, numbness, pain in extremity, feeling hot Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flu... Read more
Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flushed; her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm; upper part of her left arm started turning pink, and then red; burning feeling in her left hand fingers; her left hand got numb and tingly; her left hand got numb and tingly; her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers; the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey"; blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021; she looked like she had hives; rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist; there is a flush color around the vaccine injection site, but not on the vaccine injection site; Injection site pain/injection site is sore; left shoulder is warm to the touch around her COVID-19 Vaccine injection site; she looked completely wiped out, and pale; looked completely wiped out/Tiredness; Short of breath; her pulse was 101; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: 21Feb2021), via an unspecified route of administration in the left arm, on 17Feb2021 15:40, as single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus from 2012 to (diagnosed with Type 2 Diabetes Mellitus almost 9 years ago), neuropathy in her feet/nerves and reported that she only turns pink if she gets overheated. There were no concomitant medications. The patient did not receive any prior vaccinations within 4 weeks. Historical vaccines included influenza vaccine (reported as flu vaccine) which she gets every year and pneumococcal vaccine (reported as pneumonia vaccine) which she gets every 5 years. The patient reported that she received her first Pfizer COVID-19 vaccine on 17Feb2021 and had an allergic reaction. She said she was at a podiatry appointment, and her podiatrist told her the pharmacy had an extra COVID-19 Vaccine available. She said the pharmacy staff came to her podiatrist's office to administer her COVID-19 Vaccine. She said about 5 minutes after she received the COVID-19 Vaccine injection, on 17Feb2021 15:45, her left arm started feeling flushed, her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck. She said 20 minutes later, she walked from her podiatrist's office to a nurse's station to be monitored further. She said while she was at the nurse's station, a doctor came by twice to evaluate. She clarified the upper part of her left arm started turning pink, and then red. She said her podiatrist asked her if that was a normal reaction for her. She said she told her podiatrist she only turns pink if she gets overheated. She said her left hand got numb and tingly. She said the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey". She said her podiatrist and his nurse felt both her arms, and said her left arm was much warmer than her right arm. While she was at the nurse's station being monitored, she felt short of breath. She said she wasn't sure if she was short of breath because of her nerves. She said her oxygen level was checked and it was at 99%. She said her pulse was 101, her blood pressure was 118/76, and her blood glucose finger stick test was 128. She said she was told by the staff monitoring her, she should expect her blood glucose number to skyrocket because there is a steroid in the COVID-19 Vaccine shot. She said the staff also mentioned she can expect blood glucose spikes as the COVID-19 Vaccine's steroid goes through her system. Her fingers in her left hand became itchy while she was at the nurse's station being monitored. It was a deep down itch in her left hand fingers. She said she asked for an ice pack to put on her left hand because she uses ice packs for neuropathy in her feet, and she felt an ice pack would help with the itch and burning feeling in her left hand fingers. The doctor came to look at her again and wanted to give her IV Benadryl. Then the doctor decided against the IV Benadryl because she would be too sleepy to drive home but the doctor did eventually give her an intramuscular injection of Benadryl 25mg (clarified as Diphenhydramine 25mg in a syringe) in her upper right arm. Within 5 minutes the itching in her left hand fingers calmed down, and the redness in her left arm calmed down to a pink color. She said 20 minutes later her left arm was still pink and warm. She said she was told by the doctor if her reaction moved out of the localized area of her left arm, to go to the Emergency Room, and to use an icepack, again, on her left hand. When she arrived home, her husband said she looked like she had hives and a rash going down her left arm. Her left arm was not itchy though. She clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist. She reported that while she was at her podiatrist's office her left arm was a solid pink. She then mentioned that when she goes out in the sun and gets overheated, she turns pink. She said from her left shoulder to left elbow was warm to the touch. She said by the COVID-19 Vaccine injection site there is a flush color around the vaccine injection site, but not on the vaccine injection site. She said the COVID-19 Vaccine injection site is sore and her left shoulder is warm to the touch around her COVID-19 Vaccine injection site. She reported there were no blotchy, red marks on her left arm on 18Feb2021. She said her left arm is a pretty normal on 18Feb2021. The nurse who monitored her after the COVID-19 Vaccine shot said she needed to report her allergic reaction. She was told she needs to let the COVID-19 Vaccine staff know of her reaction before she gets her second COVID-19 Vaccine injection, so she can be monitored closely. She took no other treatment after she returned home from receiving her COVID-19 Vaccine. She reported she had a headache on 18Feb2021, clarifying her whole head hurts, and the headache has been persisting all day. She said she experienced tiredness, as well. She said the tiredness started on 17Feb2021 and can be partially attributed to the Diphenhydramine 25mg injection she was given. Her husband told her she looked completely wiped out, and pale when she got home after getting her COVID-19 Vaccine on 17Feb2021. She said she remembers being tired when she got home because her eyes were squinty. She reported feeling more tired on 18Feb2021 and her whole left arm and left hand are sore. She clarified her blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021. The patient recovered from the events "her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers" on 17Feb2021; from "upper part of her left arm started turning pink, and then red" and "rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist" on 18Feb2021; from "her left hand got numb and tingly", "the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were twingey", short of breath, "burning feeling in her left hand fingers" and "she looked completely wiped out, and pale" in Feb2021; was recovering from "left arm started feeling flushed"; has not recovered from "her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm", "blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021", "there is a flush color around the vaccine injection site, but not on the vaccine injection site", "Injection site pain/injection site is sore", "left shoulder is warm to the touch around her COVID-19 Vaccine injection site", "looked completely wiped out/Tiredness", "Headache" and "her whole left arm and left hand are sore". The outcome of the events allergic reaction, "her pulse was 101", "she looked like she had hives" was unknown.
51 2021-03-18 pain in extremity Persistent muscle and joint aches: wrist, shoulder, hands and elbows.
51 2021-03-18 tremor, numbness Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly eleva... Read more
Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly elevated blood pressure. Tunnel vision. Shaking. 30 minutes after receiving second vaccine for Covid.
51 2021-03-19 weakness, feeling hot, tremor, pain in extremity, flushing, tingling Within 15 min. Headache, eyes hurt (pressure) nose became stuffy, felt like I had a sudden sinus inf... Read more
Within 15 min. Headache, eyes hurt (pressure) nose became stuffy, felt like I had a sudden sinus infection. I became shaky and tingly. My arm was sore and felt heavy. My face became dark red and was hot to the touch. All symptoms still continue now (27 hours later) however my face is not as dark red, just pink. About 10 hours after the vaccine my muscles in my neck and shoulders began to ache. I was very fatigued. My entire body felt week and movement become a chore. Worst symptoms: Through the night I began to experience acid reflux. I have only experienced this a couple of times in my life and very mild. This was severe to the point that I couldn't sleep, my throat burned from the acid. Even drinking water was very painful and it would come back up. I located some Tums and ate 4. This was also a challenge as I couldn't hardly swallow due to the pain. After about 35 min. I began burping which help a little with the ability to keep some water down. Today I feel exhausted, my eyes still hurt, still have the headache and sinus pressure, and continue to have the acid reflux but not as severe as the night and early morning. I haven't tried to eat yet today.
51 2021-03-19 facial paralysis Patient reported facial paralysis starting 4 days after COVID dose
51 2021-03-19 feeling hot, pain in extremity Thursday night arm became sore, red, swollen and itchy. Took Benadryl. Next morning, not better. Arm... Read more
Thursday night arm became sore, red, swollen and itchy. Took Benadryl. Next morning, not better. Arm was hot, swollen, red, itchy and bruising occurred. All was on left arm at injection site.
51 2021-03-19 pain in extremity, muscle spasms Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since ... Read more
Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since day 1; brain fog since day 3; PMS like symptoms (cramps, achy feet) only on day 3; itchiness around injection site since day 1; redness and inflammation around injection site (moderate redness, size of adult woman's thumb from day 1 to day 3; increased about 25% in size on day 4 and had returned to previous size with a less red color). Has taken Tylenol when pain was present, removed headache pain on days 1-3 but not on day 4. Used cold compress on day 3 to reduce swelling but did not affect redness/swelling. Has not slept on injection site arm.
51 2021-03-19 tingling PATIENT WAS BEING MONITORED POST COVID VACCINE. INFORMED STAFF THAT HER ARM FELT A LITTLE TINGLING, ... Read more
PATIENT WAS BEING MONITORED POST COVID VACCINE. INFORMED STAFF THAT HER ARM FELT A LITTLE TINGLING, AND SOME HEAVINESS. PATIENT HAD NO PROBLEMS WITH MOVEMENT OR PAIN, NO OTHER COMPLICATIONS JUST TINGLING AND SOME HEAVINESS. CLINICAL SPECIALIST WAS INFORMED, AND PATIENT WAS FURTHER MONITORED. UPON FURTHER MONITORING PATIENT DID NOT GET WORSE, NO FURTHER SYMPTOMS AT THAT TIME. PATIENT WAS INFORMED TO FOLLOW UP WITH PHYSICIAN IF ANY CHANGES OCCURED POST MONITORING.
51 2021-03-20 unresponsive to stimuli, cold sweat, feeling cold The day after the vaccine, pt experienced typical side effects of fatigue and fever that was control... Read more
The day after the vaccine, pt experienced typical side effects of fatigue and fever that was controlled by Tylenol. The fatigue was extreme and has continued to present day. Also, she has inability to focus and concentrate. She is nauseated daily intermittently. The main complication was in post vaccination day 5, she felt worse than before. Vertigo, nausea, extreme fatigue and inability to perform ADLs and spent most of the day in bed. Approximately 1 am the next morning she woke me, cold, clammy and pale collapsing on the side of the bed with a feeling of impending doom after having diarrhea saying ?something is really wrong.? She went back to the toilet, but had a syncopal episode from standing where she fell straight and flat on her back with no attempt to break her fall. She hit her head on the marble floor and shoe molding. She was unresponsive for 10-20 seconds with no palpable pulse or visible respiratory effort before becoming arousable. She was groggy, but oriented to person and place. She was amnestic for the event. She had an approximately 6 inch full thickness laceration to her posterior scalp that required staples. I took her BP- 85/56, pulse 50, respirations were normal. Ambulance called. Mild hypotension that responded to fluid bolus. CT of head was negative and other than non-specific leukocytosis, labs were normal (CBC, CMP, TFTs, Mg and PO4).
51 2021-03-21 weakness 3:15 pm Injection, c/o dizziness afterwards and feeling weak. Advised by Paramedics to wait in obse... Read more
3:15 pm Injection, c/o dizziness afterwards and feeling weak. Advised by Paramedics to wait in observation a bit longer. Skin w/d, no diff breathing. 3:55 pm stated "feeling better". Advised if dizziness returns pull over safety and dial 911.
51 2021-03-21 bell's palsy Bell?s Palsy treated with prednisone steroid and Valacyclovir anti-viral prescription
51 2021-03-21 burning sensation Burning sensation started in my left chest area through to the back of the left shoulder blade. Then... Read more
Burning sensation started in my left chest area through to the back of the left shoulder blade. Then a light of tightness and hard to breath in the middle of my chest near my throat. then a later that day into the next day burning sensation in the very middle of my chest.
51 2021-03-21 flushing Patient received Pfizer vaccine @ 1045AM. She begin to c/o itching and flushed feeling all over @ ap... Read more
Patient received Pfizer vaccine @ 1045AM. She begin to c/o itching and flushed feeling all over @ approx 11:00am. She was escorted to triage area where she begin to c/o increased itching and tongue swelling. Epi pen and Benadryl was administered. Patient then begin to c/o difficulty swallowing and breathing. She remained alert and oriented to self, time, place and situation. She was taken to Regional per EMT's.
51 2021-03-21 pain in extremity Arm pain from shoulder to elbow
51 2021-03-22 weakness Within 45 mins started sweating, feeling a bit weak, got home still feeling weakness and tiredness, ... Read more
Within 45 mins started sweating, feeling a bit weak, got home still feeling weakness and tiredness, headache and muscle aches to injection site and leg, still have muscle aches today. Yesterday AM awoke and stomach still bothering me - when asked she has upper abdominal pain - the equivalent to a bad stomach ache ie something didn't agree with it, worst the first day and yesterday pretty bothersome. Two weeks before vaccine started breaking out in hives, small red bumps that were red and irritated and appeared on upper back, below cleavage and on on face, thought reaction to something she ate or something she may have touched even tho she wears gloves when she leaves her home, she took Benadryl for 3 days and improved. Yesterday started itching again, sister looked at back and bumps are two fold to back and buttock, traces today on face. When asked, not bites, looks like reaction to something. Caller states she doubts related as started two weeks ago, plans to see physician today, typically would get some form of steroid, how would that affect her as it lowers the immune system. Advised ok to receive the steroid if needed for other medical condition. Patient states she moved to this last year, where she typically experiences seasonal allergies and takes meds for same this time of year. Caller also states she had some left over steroid cream that she has used.
51 2021-03-22 numbness EXTREME PAIN THE LEFT SHOULDER SOMETIME RADIATING DOWN THE ARM . CANT LIFT ARM UP PAST BREAST OR R... Read more
EXTREME PAIN THE LEFT SHOULDER SOMETIME RADIATING DOWN THE ARM . CANT LIFT ARM UP PAST BREAST OR REACH IN THE BACK. SOMETIMES ARM GOES NUMB FEELING . IT ALSO CAUSED A PSORIATIC FLARE UP ON DAY 5 AFTER THE SHOT .
51 2021-03-22 tingling Difficulty breathing, severe tingling in hands and feet, spike in heart rate and blood pressure, clo... Read more
Difficulty breathing, severe tingling in hands and feet, spike in heart rate and blood pressure, closing throat, itching and hives, heart palpitations and taste of vaccine after injection and nausea.
51 2021-03-22 paralysis Paralysis to bilateral hands for 2-3minutes
51 2021-03-23 weakness I got my shot around 12:20pm. After about 10-15 minutes, my tongue felt strange (like it was larger ... Read more
I got my shot around 12:20pm. After about 10-15 minutes, my tongue felt strange (like it was larger or heavier) and my mouth was dry. I thought maybe I was just thirsty. Shortly after that, I felt a pressure toward the bottom of my neck, like someone was pushing their thumb on my lower neck. Then, I felt pressure going down my chest. I told the monitor, and she brought the nurses over. The nurses took me to a different location for monitoring. I took some benadryl at about 12:45 pm. At 12:55pm, my throat began to close up, and when I breathed in, it was like a tiny straw was in my throat. The nurses gave me an epinephrine shot and called the ambulance. This event happened on 3/20/2021. On 3/21, I was physically and emotionally drained. I still had a slight pressure going down my chest. On 3/22, I went to work and developed a headache and was nauseous and my stomach was cramping by 10am. I went to the allergist at 3pm. She told me to take non-PEG liquid benadryl and Pepcid AC. On 3/24/2021, I still feel like I have some tightness in my chest (very minimal but still present) and a headache and am continuing to take liquid Benadryl.
51 2021-03-23 feeling hot pt reported slightly light headed ,felt like her neck was warm and left gland swollen, about 1/2 hou... Read more
pt reported slightly light headed ,felt like her neck was warm and left gland swollen, about 1/2 hour after vaccine, denied any difficulty swallowing, sob or chest pain(reported she had vaccine at other pharmacy and was fine after waiting 15 min.
51 2021-03-23 pain in extremity, tingling, burning sensation, numbness When receiving the vaccine I felt a pain run down my arm, within minutes my left hand went numb. ... Read more
When receiving the vaccine I felt a pain run down my arm, within minutes my left hand went numb. Weeks later my hand still feels like I have carpal tunnel and my outer hand, ring finger and little finger get tingly, burning painful sensation.
51 2021-03-23 pain in extremity horrific arm pain from shoulder to elbow that last for approximately 48 hours; chills; respiratory a... Read more
horrific arm pain from shoulder to elbow that last for approximately 48 hours; chills; respiratory allergic reaction - stuffy head, nose running for 4 days; constant sneezing for 36 hours
51 2021-03-23 tingling Paresthesia of left arm and leg, foggy brain, muscle weakness, headache,
51 2021-03-23 tingling Metallic taste after shot. Pins/Needles on left side of face - continually near eye, every few hours... Read more
Metallic taste after shot. Pins/Needles on left side of face - continually near eye, every few hours rest of face.
51 2021-03-24 weakness low grade fever 101, for 3 days. Felt like I had been hit by a truck. Muscle aches and pains. Headac... Read more
low grade fever 101, for 3 days. Felt like I had been hit by a truck. Muscle aches and pains. Headache, sleepy, no energy. Out of work for 3 days was miserable. I'm on day 10 after the first shot of the vaccine and still feel foggy headed, low energy and tired.
51 2021-03-24 flushing, feeling hot Approximately 5 minutes post injection, patient reported feeling flush, overheated, and promptly vom... Read more
Approximately 5 minutes post injection, patient reported feeling flush, overheated, and promptly vomited. Patient was observed for s/sx of anaphylaxis. Patient was given 25mg diphenhydramine, temperature checked (temp had elevated ~2 degrees from time of injection), pulse and breathing function. Pt was visibly flushed in the face. Patient was given a cool rag as well. Patient was A&Ox3. Pt did not report any immediate issues of breathing issues, cardiac abnormalities, etc. Injection site was unremarkable. Pt reported feeling a bit better after the medication. About 7 minutes later, patient began to complain of scratchy throat and minor difficulty breathing. Patient does have a history of atopic reactions and has noted this sensation in the past when experiencing allergic reactions. Observed patient tongue and mild signs of angioedema were noted. Patient given second dose of diphenhydramine and water. Epipen was on site. Patient was observed and monitored for 25 minutes further. After approx. 5 more minutes, patient reported feeling better and looked visibly less flushed and the swelling of the tongue had diminished. Approx 5-10 min later patient was walking around, talking normally, and showed no signs of distress or reaction.
51 2021-03-24 numbness Numbness right upper extremity at vaccination site. VS WNL, patient is nervous
51 2021-03-24 pain in extremity Low fever, aches, headache, R arm soreness
51 2021-03-24 pain in extremity 101.5 fever, nausea, dizziness, fatigue , headache, muscle aches, sore arm
51 2021-03-24 tingling Client complained of tingling on left arm after receiving 1st dose Pfizer Covid vaccine (lot# ER8732... Read more
Client complained of tingling on left arm after receiving 1st dose Pfizer Covid vaccine (lot# ER8732, exp 3/28/21). Client was sitting in post vaccine waiting area 30 mins when she alerted EMT of tingling of arm. EMT performed first assessment. Vitals 1445: blood pressure 128/92, pulse 81, oxygen 99. PHN joined EMT shortly after. Client stated tingling on left arm that began 5 minutes after receiving vaccine; did not alert EMT until later. Per client no shortness of breath, chest pain, numbness, palpitations, headache, or blurry vision. Client stated this was a new onset that she did not have prior to receiving vaccine. No history of reaction to vaccines in the past. Current medication include daily vitamin and nasal spray. Allergy to antibiotic, but unsure of name. PHN assessed bilateral strength, facial droop, and arm weakness. Per client feeling fine besides the tingling sensation. PHN asked client to stay additional 15 mins for observation. Vitals 1452: blood pressure 132/92, pulse 78, oxygen 100. Alert and oriented. Tingling sensation the same, no changes. Per client history of anxiety and also had caffeine this morning, which she usually does not take. Last vitals at 1515: blood pressure 128/90, pulse 80, oxygen 100. Per client no change in tingling sensation. Was not radiating or worsening. Client advised to follow up with provider prior to receiving second dose. Client instructed to seek medical care if symptom did not improve or worsened. ER precautions given. Client left facility with steady gait at 1517.
51 2021-03-25 electric shock sensation tongue numbness/tingling, rapid heart rate, electrical or nerve zap down both arms beginning from sh... Read more
tongue numbness/tingling, rapid heart rate, electrical or nerve zap down both arms beginning from shoulders down to fingertips that happened simultaneously (one occurence), slight swelling and tingling sensation of lips.
51 2021-03-25 feeling hot As soon as shot was given warm sensation throughout body and metal taste in mouth. Felt dizzy for a ... Read more
As soon as shot was given warm sensation throughout body and metal taste in mouth. Felt dizzy for a minute as well
51 2021-03-25 throat numbness I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back ... Read more
I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back of my throat felt numb and had a significant headache. I could not sit up straight due to dizziness. By 11:30 it was hard to talk, my throat felt thick, tight, and like it was getting small. It was difficult to swallow. I was too dizzy to stand up. I would tip over when I stood up. The hospital was called and advised my family to closely observe my symptoms. At 11:20 the pharmacist gave me liquid Benadryl. At 11:30 I took hydroxyzine, prescribed after an adverse reaction to my first covid vaccine and Tylenol. At 12:30 my throat felt less enflamed but sore and scratchy. At this time my whole head was itchy and the headache was not reduced. I had a difficult time walking due to the dizziness.
51 2021-03-26 numbness developed chest pain with numbness radiating down left arm. Paramedics called, patient refused trans... Read more
developed chest pain with numbness radiating down left arm. Paramedics called, patient refused transportation to ED for evaluation. Patient instructed to seek care if symptoms continue or get worse. Patient verbalized understanding of all information.
51 2021-03-26 tingling Tingling sensation in right foot that gradually progressed to my right leg and arm.
51 2021-03-27 seizure Site: Pain at Injection Site-Mild, Systemic: Seizure-Medium, Additional Details: Patient sitting on ... Read more
Site: Pain at Injection Site-Mild, Systemic: Seizure-Medium, Additional Details: Patient sitting on chair post vaccine (waiting area) she reported (after seizure and fall) that she was feeling dizzy. She doesn't remember after that and was awake on the floor. Customer reported witnessing a seizure for 4-7 seconds BEFORE the fall. She has an abrasion on her left temple post fall. EMS called and patient refused to go to the ED. She said she would go with her friend.
51 2021-03-27 tremor Patient following vaccine developed right hand tremor following getting vaccine in her left arm. Pa... Read more
Patient following vaccine developed right hand tremor following getting vaccine in her left arm. Patient was removed from cell and brought to the medical observation area. Her BP was 128/82, P 62 RR 16 @ 3:25 she was alert and oriented times 3 ,at 3:38 her blood pressure was 141/94 and at 3:45 was 148/91 HR 68 at , O2 sat 100%. Her tremors began in her right hand and then went to her trunk and legs. She began to hyperventilate, patient was warm to the touch and an ice pack was provided to her She was not able to have a mask in place and she was hyperventilating, we asked her to focus and take deep breaths she was responsive to that and stated that helped to calm her down. Her husband was brought to her side, her vital signs continued to be obtained. at 3:50 her bP was 156/99, HR 104, pulse ox 99, at 3:55 BP was 150/102 HR 106. EMS was called as patient continued with tremors and her blood pressure continued to be elevated . EMS arrived , her final blood pressure was 156/99, HR 90 and pulse ox was 99%. EMS transported patient out of the center via stretcher. Patients husband planned to follow her to the hospital
51 2021-03-28 weakness, muscle spasms Over night, "calf muscles were contracting really tight over and over. Every time the muscle would ... Read more
Over night, "calf muscles were contracting really tight over and over. Every time the muscle would stop, it would start again over and over. I also woke up feeling weak and a headache"
51 2021-03-28 weakness Continuous weakness/fatigue and discomfort/pain in upper left arm. Having difficulty doing normal t... Read more
Continuous weakness/fatigue and discomfort/pain in upper left arm. Having difficulty doing normal tasks like lifting pan out of oven, carrying a grocery bag, typing on computer at work, painting/creating art, holding dogs leash, etc. Feeling of fatigue/discomfort is present even when I am sitting still.
51 2021-03-28 feeling hot 11 hours after receiving the vaccine chills started, and a fever of 99.5. Over the next 18 to 20 ho... Read more
11 hours after receiving the vaccine chills started, and a fever of 99.5. Over the next 18 to 20 hours temp rose to 102. Chills were uncontrollable until I began taking tylenol to bring down tge fever. Then I began to get very hot...sweating. alternated chills and sweats during that 18 to 20 hour period. Fever finally broke but ended with a slight headache. Also during the same time period of the fever I experienced diarrhea. Woke up less than 48 hours post vaccine feeling better, but extremely tired.
51 2021-03-28 numbness, weakness Fever for 24 hours, right arm numbness/weakness
51 2021-03-28 pain in extremity, weakness Effects Lasted approx. 15 hours Sore Left Arm - (Expected), Tiredness, Headache, Muscle Pain, Chills... Read more
Effects Lasted approx. 15 hours Sore Left Arm - (Expected), Tiredness, Headache, Muscle Pain, Chills, Sweats, Joint Pain, Nausea, Throat felt swollen, Shallow Breathing, Swelling in Face (Left side of face for 48 hours), Weakness
51 2021-03-28 pain in extremity, discomfort Patient reports second dose of Pfizer on Friday. Reports intermittent chest pain and pressure since... Read more
Patient reports second dose of Pfizer on Friday. Reports intermittent chest pain and pressure since Saturday. Reports she was dizzy on Fri and Sat., denies that she is dizzy currently. Denies any SOB but reports her pain does radiate into her L arm.
51 2021-03-28 pain in extremity Symptoms started approx. 11 hrs. post injection- sore arm, fever, body aches. Max temp. 104.2 and f... Read more
Symptoms started approx. 11 hrs. post injection- sore arm, fever, body aches. Max temp. 104.2 and fever was constant/ did not go to baseline until Sunday 3/28/21 around 6pm. I have been sweating on and off since fever broke. Body aches were severe, Moderate HA with onset of fever and body aches. Arm pain from injection remained mild to moderate with no swelling or redness. GI symptoms- diarrhea, pain and nausea started 24 hours after vaccine and mild symptoms remain today 3/29/21. Fatigue present. I had a severe COVID illness back on 12/09/20 with Monoclonal Antibodies on 12/11/20 and I did not feel as bad as I did with this vaccine. With the vaccine my fever never broke for almost 48 hours. With Bilateral COVID pneumonia I only spike temps mostly at night and broke with Tylenol and Motrin.
51 2021-03-28 tingling Chills, fever x2 days. From shot #1. Chills, Fever x2 days, 2nd day swelling size of a quarter devel... Read more
Chills, fever x2 days. From shot #1. Chills, Fever x2 days, 2nd day swelling size of a quarter developed. 3rd day R arm swelling, hot to touch, sheering pain size half of a grapefruit. Tingling in right hand. Sought medical help.
51 2021-03-28 tenderness Approximately 24 hrs after receiving my 2nd COVID Vaccine, I experienced swelling and tenderness in ... Read more
Approximately 24 hrs after receiving my 2nd COVID Vaccine, I experienced swelling and tenderness in the underarm area. As of Monday, it is slightly less tender and swollen but still has tenderness.
51 2021-03-29 numbness Patient experiencing tingling lips, lump in throat, and left arm numbness. Reports worsening over w... Read more
Patient experiencing tingling lips, lump in throat, and left arm numbness. Reports worsening over wait period. Provider notified. Escorted to ER.
51 2021-03-30 feeling cold, hot flush Dissiness, hot and cold flashes
51 2021-03-30 feeling cold Had first dose of COVID vaccine Wednesday 3/24 Thursday started with chills , could not get warm , s... Read more
Had first dose of COVID vaccine Wednesday 3/24 Thursday started with chills , could not get warm , slight nausea, headache 10/10 - took Excedrin and that helped Friday same symptoms as Thursday but did vomit x 2 Afebrile Has had headaches daily since vaccine but has managed them with Excedrin Saturday thought she was getting better, dizziness and nausea that started later in the day, slight chills Sunday - nausea, dry heaves- , freezing all day Was unable to keep anything down - tried crackers and water Tried Dramamine due to the dizziness and nausea - helps a little States she is still using Dramamine and it is helpful Monday and Tuesday still having waves of nausea and dry heaves States she is able to eat and drink and keep things down, and is "taking it easy with the food" Stated constantly feels like a weight is sitting on her throat Describes as pressure, burning and feeling like a weight is sitting there constantly - area of the chin, down her throat to the breastbone in center of chest between her breasts Stated this has been present for 3 days and has been a constant feeling Rates this discomfort as 8/10 Patient referred for ER for assessment today
51 2021-03-30 numbness Numbness in hands and feet Intermittent; This is a spontaneous report from a contactable other healt... Read more
Numbness in hands and feet Intermittent; This is a spontaneous report from a contactable other health care professional reported for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown) via unspecified route of administration in left arm on 19Feb2021 12:30 AM at age of 51 years old at single dose for COVID-19 Immunization. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies reported. Other medications the patient received within 2 weeks of vaccination included Natasia (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previous received the first dose of BNT162B2 in left arm on 22Jan2021 12:30 AM at age of 51 years old for Covid-19 Immunization. Patient experienced numbness in hands and feet intermittent on 22Feb2021. Since the vaccination, the patient had not been tested for COVID-19. The report was reported as non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was not received treatment for the adverse event. Outcome of events was not recovered. Information on the lot/batch number has been requested.
51 2021-03-30 numbness 2 hours after the shot i thought I had got bitten by a mosquito because I had an itchy raised bump o... Read more
2 hours after the shot i thought I had got bitten by a mosquito because I had an itchy raised bump on my jaw I looked in the mirror and my left side of my neck was flame red then it spread to the front of my neck then it spread to the right side. It started moving down to my chest. The rash started getting raised hives that looked like they were turning into blisters.. It was horribly itchy but the worst part is it felt like I had been scorched. Luckily I had antihistamines here on hand that eventually thank God turned it around. The next day on Monday I was in almost a comatose sleep like anesthesia I didn't know what day it was. Then on Tuesday my right side of my face went numb and felt like it was drawing down. My speech was slurry I was drooling out of my right side and I was having glitches with my memory. Today I'm still having speech difficulties gait problems and I'm hearing roaring in my ears. This is so terrifying.
51 2021-03-30 pain in extremity, fibromyalgia Approximately 10 minutes after shot was administered, I noticed no pain at the injection site; inste... Read more
Approximately 10 minutes after shot was administered, I noticed no pain at the injection site; instead there was pain in my left forearm where there was a large hard lump. The pain traveled to other large muscles over the next two days, including legs, hips, back. It seemed the Fibromyalgia symptoms were extremely intensified.
51 2021-03-30 pain in extremity Redness about the size of a baseball on day 2,3&4 after second inoculation. Pain and hot to the to... Read more
Redness about the size of a baseball on day 2,3&4 after second inoculation. Pain and hot to the touch in the area.
51 2021-03-30 tingling, numbness Almost immediate onset of neck pain and numbness tingling in hand on the same side of injection. Ab... Read more
Almost immediate onset of neck pain and numbness tingling in hand on the same side of injection. About 30 minutes later face became numb on same side as injection including metallic taste in mouth and sore teeth. Feels like numbing from dentist office. It?s now 4 1/2 hours post injection and numb feeling in face and tingling hand exist.
51 2021-03-31 bell's palsy, migraine Migraine started on 3/23. Struck with Bells Palsey on 3/25.
51 2021-03-31 burning sensation, feeling hot 1st Dose - effects surfaced apprx 5 days later - painful swollen lymph nodes 2nd Dose - effects surf... Read more
1st Dose - effects surfaced apprx 5 days later - painful swollen lymph nodes 2nd Dose - effects surfaced within hrs. Massive headache - affected peripheral vision, nausea, body aches, hot, and chills, mild dry heaves, vomitted once, weak & slightly faint, dizzy , sharp painful lymph nodes (left collar bone, Left underarm area, side of left breast, slight burning sensation, Thursday woke up with pain in back of knees, back, neck and head, in bed Wed evening through Friday, touch of diarrhea, bowel movement seemed to slightly alleviate headache, touch of stomach gas, back to work Monday, Tuesday woke up with massive headache again unable to lift head from bed, nausea, & chills unable to go to work. Wednesday back to work - got home felt fatigued slept from 5pm to 6:45 am.
51 2021-03-31 muscle spasms, flushing, weakness, hot flush Sudden, intense Chills, bowel evacuation, nausea, inability to stand, hot flashes and then on and of... Read more
Sudden, intense Chills, bowel evacuation, nausea, inability to stand, hot flashes and then on and off for 8 days, and counting, even with medication. These symptoms started after 8 days from the shot and the original effects (flushing, muscle cramps, weakness) which occurred immediately following the shot. It has now been 16 days from the shot and my symptoms are on-going.
51 2021-03-31 pain in extremity, involuntary muscle movements, bell's palsy hard of hearing; Bell's palsy; Left eye felt weird/weird feeling like when went to the dentist and g... Read more
hard of hearing; Bell's palsy; Left eye felt weird/weird feeling like when went to the dentist and get the Novocain shot; Left side of mouth muscle not holding water while brushing teeth; Cannot close left eye/eye wasn't moving; Left eye burning during shower; sick; cannot move that part of your mouth; Sore Arm over Weekend; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 12Mar2021 08:15 (Lot Number: EN6204) at single dose for covid-19 immunization. Medical history was none. Concomitant medication included diphenhydramine hydrochloride (BENADRYL Tablet). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200) on 19Feb2021 and experienced felt really tired, and received flu shot. The patient experienced bell's palsy on 18Mar2021, sore arm over weekend on an unspecified date in 2021, Left eye felt weird/weird feeling like when went to the dentist and get the Novocain shot on 18Mar2021, left side of mouth muscle not holding water while brushing teeth on 18Mar2021, cannot close left eye/eye wasn't moving on 18Mar2021, left eye burning during shower on 18Mar2021, sick in 2021, cannot move that part of your mouth in 2021, hard of hearing on an unspecified date. She felt great over the weekend other than a sore arm. Morning on 18Mar2021 when she woke up her left eye felt weird. When brushing her teeth she noticed the left side of her mouth muscle was not holding water to spit out. Looked in the mirror and noticed when she smiled her left eye wasn't moving. Went to the emergency room and the doctor told her she has Bell's Palsy. Explained that was why she cannot close her left eye. Was given two medications to take; one a steroid and one a antiviral. Left eye has been feeling weird, like when you look away from your cell phone and one eye hasn't dilated or adjusted to the darkness yet. Stated she took a sick day from work today. Mentioned again her left eye burning in the shower and that she has to sleep with an eye patch. She was hard of hearing. Stated she had hearing aids and can currently hear call handler fine. Had a CAT scan and everything at the emergency room this morning. Her grandmother and aunt died from a stroke and she was concerned that she had one. She cannot close her left eye completely. Stated was a weird feeling like when went to the dentist and get the Novocain shot and cannot move that part of your mouth. The doctor told her he thought it will last for 2 weeks. Stated that it could've started overnight but she was uncertain as she was sleeping and didn't notice it until this morning. Mentioned her husband was at the hospital all day yesterday for procedures. After receiving her second dose of the vaccine she thought she didn't feel to bad at all, not tired like with the first one; until she woke up with this today. Stated no for medications but mentions that on 11Mar2021 she had bad allergies and was like a water faucet. She took Children's Benadryl 12.5mg 2 tablets and some eye drops. Stated that it helped. Thought she was allergic to something in the building. Stated was given Prednisone, as she was reading the label she notices she was supposed to take two a day and had only taken 1 this morning. Prednisone is prescribed as 20mg 2 tablets by mouth every day for 7 days. Spelt out name of antiviral medication as IC Valacyclov. Prescribed as 500mg 2 tablets by mouth three times a day. Also has eye drops to keep eye moist. Has eye patch for bedtime. Was instructed to manually close left eye and cover with eye patch at night. Mentioned that she had a flu shot in October no issues voiced. Nephew with Covid, Niece that had Covid. Stated she was not around them. There was no physician office visit reported. The patient underwent lab tests and procedures which included blood sugar: normal, blood pressure: normal, CAT scan: normal on 18Mar2021. There was treatment and emergency room visit except event hard of hearing. The outcome of the events was unknown.
51 2021-03-31 pain in extremity Sore arm, terrible headache, fatigue and generally not feeling well - like I was about to get the fl... Read more
Sore arm, terrible headache, fatigue and generally not feeling well - like I was about to get the flu
51 2021-03-31 pain in extremity Swollen armpit lymph nodes, sensitivity and left arm pain
51 2021-03-31 tremor Chills, shaking, body aches about 12 hrs after shot. Body aches 3 days total. Injection site itchi... Read more
Chills, shaking, body aches about 12 hrs after shot. Body aches 3 days total. Injection site itchiness day after and continues.
51 2021-04-01 flushing Immediate whole body sensation. Dissasociative feeling at leaving injection booth. Tachycardia start... Read more
Immediate whole body sensation. Dissasociative feeling at leaving injection booth. Tachycardia started immediately when sitting in observation room. Observer noted rash and flushing on chest and face. Medics called. Blood pressure 182/108, heart rate 152, o2 sat 100. Taken to triage area. Had a hard time responding to questions because tongue felt thick. Airway was clear despite edema. I was taken by ambulance to to Medical Center. The paramedics wanted to administer Epi but I was hesitant since I was still able to breathe and I didn?t want to further increase blood pressure. I have a narrative to paste but the Continuation Page is not letting me input text. Please email me.
51 2021-04-01 pain in extremity I had the first shot on March 1st. My arm was a little swollen and sore for two days, and I was ext... Read more
I had the first shot on March 1st. My arm was a little swollen and sore for two days, and I was extremely tired, but other than that no adverse reaction. I received my second shot on March 19th, my arm again swollen and sore, and I could barely keep my eyes open the rest of the day. On 3/20/21, I woke at 8:30, feeling like I had hardly slept at all even though I had slept for 9 hours. I woke up wheezing, which led to me coughing and chills but no fever. The exhaustion I had felt after the first shot, was nothing compared to this. I thought it would go away, but it didn't. I also noticed a lot for fluid retention in my lower legs and stomach area. When I got on the scale, in the 20 days from the 1st shot til the day after the second shot I had gained 20 pounds of fluid. I was stunned. I could barely do a simple task, then I would have to sit down to rest for a minute, and would immediately fall asleep for 2 to 3 hours. I went to my doctor's on 3/22/21. They did a covid test, it was negative. The doctor said I was definitely wheezing and gave me the only sample inhaler that they had in stock Anorro to try to open up my airways. After a week, I was still having the issues, went back to doctor on 3/29/21 This time they perscribed 12 days of taper steroids. I am on day 4. I also received a referral to see a pulmonary specialist. I am still dealing with the exhaustion, wheezing and cough.
51 2021-04-01 pain in extremity Can't move shoulder - extreme pain 17 days of not moving arm and pain. Injection was too high, vac... Read more
Can't move shoulder - extreme pain 17 days of not moving arm and pain. Injection was too high, vaccine in rotator cuff tissue. Hasn't dispersed. It's been 17 days.....
51 2021-04-01 tingling, tremor within 10 minutes, had trouble breathing and tingling hands. got Benadryl shot and then had shakes ... Read more
within 10 minutes, had trouble breathing and tingling hands. got Benadryl shot and then had shakes throughout body. rising blood pressure. admitted to ER. After approximately 4 hours it subsided.
51 2021-04-02 weakness Constant headache since 4 hrs after shot. Had rainbow colors appear for an hour in my eyes evening o... Read more
Constant headache since 4 hrs after shot. Had rainbow colors appear for an hour in my eyes evening of april 2nd. Blood pressure at drs was very low. Dizzy weak feeling. Body aches on April 2nd. Headache as of april 3rd has still not went away.
51 2021-04-02 burning sensation Cheeks and chin because bright red/pink and there was a burning sensation. I called the Dr's office,... Read more
Cheeks and chin because bright red/pink and there was a burning sensation. I called the Dr's office, they said as long as I didn't have trouble breathing to watch it. The redness began to fade after 24 hrs. The burning sensation stayed for another 24 hrs and continues intermittently to this day.
51 2021-04-02 feeling hot Left side of body is achy with what feels like random muscle pulls all down the left side. The lef... Read more
Left side of body is achy with what feels like random muscle pulls all down the left side. The left front of my neck around my carotid artery feels hot or icy/hot. As if it was pulled. Generally not feel well.
51 2021-04-02 flushing Headache, flushed face, and vomiting (1x)
51 2021-04-02 migraine, pain in extremity 1. Mild allergic response: lip and eyelid swelling, itchy throat, scratchy/itchy feeling 2. 1.5 inch... Read more
1. Mild allergic response: lip and eyelid swelling, itchy throat, scratchy/itchy feeling 2. 1.5 inch diameter bruise at injection site 3. Mild arm pain 4. Intermittent fever?99.1, 99.6, 100.1, 102.1, 99.3 5 Two days after horrible headache with halos and occasional double vision 6. Brain fog and tiredness
51 2021-04-02 pain in extremity headache; arm started aching; The lymph nodes in her arm are still swollen; Swelling in the armpits ... Read more
headache; arm started aching; The lymph nodes in her arm are still swollen; Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits; Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits; itching on both of her feet; red circle where she got the injection. It was the size of a dime and only there on 28Jan2021; arm that she got the vaccine in got very large; Swelling in the upper breast area/swelling in her upper chest; Swelling and pain in the neck/Neck pain; Swelling and pain in the neck/Neck pain; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 15:00 as single dose for covid-19 immunization.Medical history included menopause or has been through menopause, Flu shot, hormonal issues, she started with a bizarre virus, whole lymph node response; It was lymph nodes in her neck, arm pits, and groin. Every two days she would have lymph nodes reacting, she had a little infection and inflammatory markers come back positive. Concomitant medication included probiotics, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient previously took flu for influenza immunisation and experienced peripheral swelling, tetanus vaccine for immunisation, amoxicillin, and experienced drug hypersensitivity, flagyl [metronidazole] and experienced drug hypersensitivity. The patient reported adverse events associated with her first Pfizer COVID vaccine shot. She experienced swelling in the upper breast area, swelling and pain in the neck, swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared. She thought on whether to get the second shot of the vaccine considering these side effects since her doctor did not know why this was happening according to her. She thought she would report some side effects after one shot of the Pfizer COVID19 Vaccine. It was strange. She did not read the symptoms until seven days out. Then she saw some have reported a lot less. After the shot, that night she had swelling in her upper chest. She thought it was lymph nodes in the breast and chest area on the side she got the shot. The next day her arm that she got the vaccine in got very large. Then, she does not know if it was related, two days later she had itching on both of her feet. It was the tops of her feet and only for a couple of days. She is not counting that. Day five after the shot has been the main problem. Her armpits started itching like crazy. It was severe itching and swelling in her armpits. The itching lasted for three to four days. The lymph nodes in her arm are still swollen. It was five days after the shot. It was both armpits. The night of the shot she had a lot of neck pain and she thought it was probably the lymph nodes in the back of her neck. That has lasted and was slowly diminishing. The patient was not planning on getting it. There was an agency that for assisted living for people that need help. They were giving it and had extra doses. This guy in charge at the assisted living house offered it to caller and caller's husband because her and her husband run a behavior health counseling. He offered it to them as healthcare professionals. He was given a batch for the residential agency but had extras. She was going through menopause or has been through menopause. She has hot flashes and has hormonal issues. The first week of December she started with a bizarre virus. She got tested for COVID and it was negative. It was not a rapid test it was a sendoff. Through that illness she had a whole lymph node response which was super unusual. The doctor said it was really strange. It was lymph nodes in her neck, arm pits, and groin. Every two days she would have lymph nodes reacting. She had recovered from that and was back to normal. Four days before she got the shot all of that had resolved. Prior to getting the vaccine she had been tested for Lymphoma and it was negative, and she had a little infection, and her white blood count was normal. She had inflammatory markers come back positive prior to getting the vaccine. She went to the doctor on 27Jan2021 and asked if she should get the shot. The doctor said to do it because if she got COVID it would be worse. She was going to have a follow up with doctor for the ongoing stuff and he might do more test. Never in the course of any of that did she have itching armpits or swelling that lasted all this time. She never had chest swelling. The shot in the arm and it moved across her chest. It was reported that, back in the 90's, in 1993 or 1994, flu shots caused her arm to swell really large and stayed swollen for three months. That was the last three flu shots she got in the 90's. Then the doctor said not to get them. No one said why. She doesn't have allergy to eggs or anything that she knows to cause that. She has gotten all other vaccines and tetanus within the last 10 years. Her arm would kind of react but not like that. It went away in a reasonable amount of time. She didn't get a fever. The patient does not have NDC, lot and expiry for flu shots, other vaccines or tetanus to provide. When her kids were younger, they all had to be vaccinated for rabies. She did not have any reaction at all with those vaccines. She has allergies to antibiotics. She does not have lot numbers, NDC, or expiry for the antibiotics she was allergic to. She was allergic to Amoxicillin, Flagyl, Doxycycline, and Sulfa drugs. She has allergies to adhesive and contrast dye. No food allergies. She has allergies to dog and other environmental allergies. She does not take any medications for any of that. She has never had any anaphylactic shock of any kind. It has always been hives. The patient experienced swelling in the upper breast area/swelling in her upper chest, swelling and pain in the neck/neck pain, swelling and pain in the neck/neck pain, swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/it is both armpits, arm that she got the vaccine in got very large, itching on both of her feet, red circle where she got the injection. It was the size of a dime and only there on 28jan2021, headache, arm started aching and the lymph nodes in her arm are still swollen. Outcome of the events Swelling in the upper breast area/swelling in her upper chest and arm that she got the vaccine in got very large was recovering, outcome of the events Swelling and pain in the neck/Neck pain, Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits, itching on both of her feet and red circle where she got the injection. It was the size of a dime and only there on 28Jan2021 was recovered and outcome unknown for other events. Information on the lot/batch number has been requested.
51 2021-04-02 pain in extremity Tiredness/fatigue headache muscle pain/body aches chills low grade fever Overall feeling unwell inje... Read more
Tiredness/fatigue headache muscle pain/body aches chills low grade fever Overall feeling unwell injection site pain/arm pain and redness Note: Symptoms lasted 36-48 hours
51 2021-04-02 tingling, numbness About an hour after getting my first Pfizer shot, I noticed intense numbness and tingling in the (le... Read more
About an hour after getting my first Pfizer shot, I noticed intense numbness and tingling in the (left) arm that got the shot. From the area in the shoulder down to my fingertips. After two hours symptoms are less but still remain.
51 2021-04-02 tremor Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild
51 2021-04-03 muscle spasms, pain in extremity diagnosed with Shingles/zoster on 23Mar2021; Most concerning is the rash on upper right thigh. Began... Read more
diagnosed with Shingles/zoster on 23Mar2021; Most concerning is the rash on upper right thigh. Began within 48 hours and has continued to spread. It is raised and sensitive to touch.; It began with fatigue within 3 hours of vaccination; Achy leg muscles.; Intense leg cramps began with in 36 hours; Achy lower back; progressed the achiness in right thigh, buttock and lower back; progressed the achiness in right thigh, buttock and lower back; This is a spontaneous report received from a contactable consumer (patient) and contactable Healthcare Care Professional. This Healthcare Care Professional reported in response to the HCP letter sent was processed together. A 51-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date: Not provided) via unspecified route on 18Mar2021 at 09:45 PM in the right arm at single dose for COVID-19 immunization. Patient's medical history included stem cell transplant 2 years ago and allergic to Lobster and Penicillin. On 26Feb2021 the patient received Hepatitis B vaccine, MMR and PPV23 in the right arm. Concomitant medication included levothyroxine. The patient did not experience COVID-19 prior or post vaccination. On 18Mar2021 at 01:00 PM, within three hours after vaccination the patient had fatigue and achy leg muscles progressed the achiness in right thigh, buttock and lower back. Also, within 48 hours the patient experienced rash on upper right thigh and has continued to spread. It was raised and sensitive to touch. Not itchy. Moderate to severe leg cramping within 36 hours, achy lower back mostly on right side, rash within 40 hours, shooting leg pain and worsening/spreading rash. The patient diagnosed with shingles/zoster on 23Mar2021. famciclovir and Tylenol was given as treatment. Outcome of events was not recovered. Information on the lot/batch number has been requested.
51 2021-04-03 night sweats I had high blood pressure the day after receiving the vaccine. As high as 165 over 102. It has now b... Read more
I had high blood pressure the day after receiving the vaccine. As high as 165 over 102. It has now been three days. It's still a bit higher than normal. But working its way back down. My usual reading, for many years now, has been 120 over 80. Not surprisingly, I had chills, a headache, and night sweats. But the high blood pressure was by far the most concerning. I do not regret getting the vaccine. But wish I had known.
51 2021-04-03 pain in extremity Arm pain began within a few hours of injection. Mild fever, restlessness began 9 or 10 hours after i... Read more
Arm pain began within a few hours of injection. Mild fever, restlessness began 9 or 10 hours after injection ? treated fever with acetominophen 325 mg. Headache began about 14 or 15 hours after injection ? treated with acetominophen 325 mg. Mild stomach upset (without vomiting) about 23 hours after injection (maybe caused by acetominophen on an empty stomach)
51 2021-04-03 pain in extremity Arm soreness; Fatigue; Throbbing headache; Rib and upper back pain; Rib and upper back pain; Axilla ... Read more
Arm soreness; Fatigue; Throbbing headache; Rib and upper back pain; Rib and upper back pain; Axilla pain; Rapid pulse; Temp; This is a spontaneous report from a contactable other health Care Professional. A 51-years-old female patient received first dose of BNT162B2 (PFIZER COVID-19 VACCINE ;solution for injection; Lot Number: EN53185/21) via intramuscular to right arm on 29Jan2021 at 11:00 as single dose for COVID-19 immunisation. Medical history included hypertension, gastrooesophageal reflux disease, anxiety, thrombosis, COVID-19. The patient had Covid prior vaccination. Concomitant medications included labetalol, NORVASC, ELIQUIS, OMEPRAZOLE, ZOLOFT, VIT D and VIT C. The patient experienced Arm soreness, temp, fatigue, throbbing headache, rib and upper back pain, axilla pain, rapid pulse on 29Jan2021 at 20:00. The patient underwent lab tests and procedures which included body temperature with unknown result heart rate with rapid result, viral test with negative on 01Feb2021. Therapeutic measures were taken for the events with Tylenol. The outcome of the events was recovering. Follow-up activities have been completed and no further information is expected.
51 2021-04-03 tingling First night tingling in feet. Next light tingling in hands and feet. Third day major tingling in h... Read more
First night tingling in feet. Next light tingling in hands and feet. Third day major tingling in hands, feet, one side of leg, and sides of face.
51 2021-04-03 speech disorder Memory loss, memory issues; Blurred vision; Severe headache down to her neck; still little bit stumb... Read more
Memory loss, memory issues; Blurred vision; Severe headache down to her neck; still little bit stumbling/stumbling like couldnot keep her balance like tripping; Hard to get her words out; very lost and confused; very lost and confused; cognitive issues; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 20Jan2021 (at the age of 51-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, "she guess this was the number her doctor told her she needed to call to report side effects from vaccine. She got it on 20Jan2021, first Pfizer vaccine and then two weeks later, she started experiencing memory loss, memory issues, blurred vision and severe headache down to her neck, hard to get her words out, very lost and confused, stumbling like couldnot keep her balance like tripping/ still little bit stumbling, that was after her first vaccine and they sent her to the emergency room, she got an MRI and 'CAT' (not clarified) scan to see as she was having symptoms."Consumer further stated, " she have more information, two weeks after the first dose was when the cognitive issues started and then, a week to the day later, she started feeling herself again maybe 90 percent. Then this afternoon, she got the second vaccine dose and next day she was feeling okay and day and a half later, it all started all over again, headache, back of the head pain, memory loss, blurred vision, all started again. She got an MRI this time and the other day, since then she have severe headache all day, every day, pain down my neck and still little bit stumbling. She went to her neurologist and he said all of her symptoms were symptoms that someone would have with the concussion but she never felt like, she don't have a concussion (hence, concussion not captured as event as consumer was not sure). So, she wanted her to call this number as she said that she believed that memory cognitive issues were all from the vaccine and she guess it was needed to be reported."Outcome of the events were unknow.
51 2021-04-04 feeling hot Red, blotchy, hot to the touch rash on top of forearms. Lasted 3 days.
51 2021-04-04 migraine Slight fever, chills, body aches, constant headache (triggered migraine), fatigue, injection site so... Read more
Slight fever, chills, body aches, constant headache (triggered migraine), fatigue, injection site soreness.
51 2021-04-04 tension headache Extreme pain and tightness on right side, back of head, back of neck, and right shoulder. Could not ... Read more
Extreme pain and tightness on right side, back of head, back of neck, and right shoulder. Could not turn head to the right nor look up. Lasted 9 days.
51 2021-04-05 flushing, burning sensation Burning sensation that "goes right down though my body" gesturing neck to knees. Flushed face 12:15 ... Read more
Burning sensation that "goes right down though my body" gesturing neck to knees. Flushed face 12:15 132/40 Hadn't eaten yet and history of anxiety. Had a granola bar and cranberry juice. Laid supine 12:40 felt better 12:50 ambulatory
51 2021-04-05 migraine Migraine for 36 hours & fatigue
51 2021-04-05 nerve pain, tingling Shingles developed on the right side of my face above my jaw. Tingling, red, blisters, nerve pain I... Read more
Shingles developed on the right side of my face above my jaw. Tingling, red, blisters, nerve pain It is not over yet.
51 2021-04-05 pain in extremity, weakness 2nd dose symptoms: dragging/low energy, chills, upset stomach, onset of sudden constipation, stomach... Read more
2nd dose symptoms: dragging/low energy, chills, upset stomach, onset of sudden constipation, stomach swelling, runny nose, constant taste of a chemical, uncomfortable/not a pain in throat, and sore arm. About 4:00 PM, I felt pains in my chest and I could not hear. My ears felt very hot and then became so dizzy I fell to the ground.
51 2021-04-06 weakness I had normal side effects as mentioned in my paperwork, such as; injection site pain, neck pain on t... Read more
I had normal side effects as mentioned in my paperwork, such as; injection site pain, neck pain on the left side, fatigue, joint pain, weakness, difficulty being mobile. There was also depression, the extreme joint pain and weakness made the depression feel worse. I didn't have any treatment but the pain lasted 3 or more days and the depression and joint pain for more than 7 days.
51 2021-04-06 burning sensation, numbness 1. Within 3 minutes of getting the vaccine I had the closing of the throat, sneezing, feeling of a c... Read more
1. Within 3 minutes of getting the vaccine I had the closing of the throat, sneezing, feeling of a closed throat, rapid heart rate, high blood pressure- 145/74. My normal rate is 104/69. I began to have very numb toes on the next day and burning in the toes in the evening. I also had itchy toes and on the 3rd day had several sores on my right foot making it difficult to walk. On the 5th day the pain was so intense that I could not sleep. It felt like fire was in my toes. A call to Dermatology suggested that I had "Covid-Toes" brought on from the vaccine and they suggested that I see a medical Dr for a check up. Dr saw me on that Friday and I had also acquired a rash on my belly.
51 2021-04-06 difficulty speaking Hoarseness throat swelling, itching. VS at 1153: BP 174/115, HR 83, O2Sat 100. VS at 1159 BP 149/1... Read more
Hoarseness throat swelling, itching. VS at 1153: BP 174/115, HR 83, O2Sat 100. VS at 1159 BP 149/107, HR 90, O2 Sat 100% Pt was awake alert and oriented x4, heart + lungs clear to auscultation, no stridor, no hives, no tongue/lip/face/oropharyngeal swelling, cap refill < 2 seconds Received 25 mg IM Benadryl with resolution of symptoms, just some mild residual itchiness. EMS/ED advised, Pt declined and was advised to seek emergent medical evaluation if symptoms worsen or return. Pt was advised not to drive herself
51 2021-04-06 flushing Pt c/o "feeling flushed and like I was going to pass out." c/o chest pain at level 1 verbally. State... Read more
Pt c/o "feeling flushed and like I was going to pass out." c/o chest pain at level 1 verbally. States "it could be nerves"as was notified at 0500 of father in law's sudden passing this morning and upset from news. Pt verbal and oriented x 3. S&S began as pt was going to sitting position immediately after receiving vaccine injection. Pt obvserved for 50 minutes then left as states" I think I'm fine. I don't have any chest pain, sob, or other c/o, other than grief over loss of father in law". No rash noted. Vitals unchanged. see chart for v/s. Pt states did receive one dose of Pfizer vaccine on Jan 11, 2021 but didn't receive 2nd dose because of feeling "guilty" that there were other people needing it more than she was. Pt states has new dx (after 1-11-21) of cardiomyopathy unknown cause. Pending vascular consult.
51 2021-04-06 flushing Initially felt dizzy (3:15pm). Had patient sit down. Lips started tingling. Had patient lay supine... Read more
Initially felt dizzy (3:15pm). Had patient sit down. Lips started tingling. Had patient lay supine with feet elevated (3:30). Patient started having trouble breathing and could not move her lips and face became flush (3:45), called 9-1-1.
51 2021-04-06 hot flush Hot flashes, began within 10min of injection?resolved after 2hours Dizziness, began within 40min of ... Read more
Hot flashes, began within 10min of injection?resolved after 2hours Dizziness, began within 40min of injection?resolved after 3hours Hallucinations, began approx 45min post injection?resolved after 3hours Wild mood swings, laughing then crying, began approx 45min post injection?resolved after 2hours Vision improved, began approximately 12hours post injection?continues, previously -4.25 now approx -2
51 2021-04-06 numbness Systemic: right arm numbness & scratchy throat-Mild
51 2021-04-06 tingling Within a few minutes I became extremely dizzy and disoriented a bit, immediately following I had ext... Read more
Within a few minutes I became extremely dizzy and disoriented a bit, immediately following I had extreme difficulty swallowing as if I had a ball in my throat. Nurses recognized and immediately gave me Benadryl. Today I feel a lot of pressure in my head, fatigue, tingling in lips and right hand.
51 2021-04-06 tingling 4/2/2021 11pm left hand red swollen 4/3/2021. Extreme fatigue slept 18 hours very exhausted all day ... Read more
4/2/2021 11pm left hand red swollen 4/3/2021. Extreme fatigue slept 18 hours very exhausted all day and night, woke up with face tingling from top of scalp to top of lips across entire area left to right . 4/5/2021. Chills and diarrhea, still fatigued and facial tingling continues 4/6/2021 tingly face continues 4/7/2021 tingly face continues
51 2021-04-07 weakness, feeling hot significant dizziness, light headed, hot, weakness. Monitored and Resolved without treatment in 30 m... Read more
significant dizziness, light headed, hot, weakness. Monitored and Resolved without treatment in 30 min.
51 2021-04-07 flushing Approximately 3 minutes after injection, I became flushed, light headed, and nauseated. I did not co... Read more
Approximately 3 minutes after injection, I became flushed, light headed, and nauseated. I did not contact anyone at the time, as I was waiting for the effects to pass. I stayed at the facility for 20 minutes before leaving, as the effects finally passed. However, the injection site is still sore and warm to the touch, 3 days after the initial injection.
51 2021-04-07 migraine Fever, chills, body ache headache for first 2 days after 2nd dose. Headache of Migrane magnitude p... Read more
Fever, chills, body ache headache for first 2 days after 2nd dose. Headache of Migrane magnitude persists for 6 days after 2nd shot. Such bad headache I am throwing up and nauseous. Still having headaches. Tiredness.
51 2021-04-07 pain in extremity This is the second day of flu like symptoms and a low grade fever. The date listed in the beginning ... Read more
This is the second day of flu like symptoms and a low grade fever. The date listed in the beginning was the date of my second shot. After the first shot on 3/13 I only had mild symptoms like two days of soreness in arm and moments of unexplained anxious feelings after a couple of weeks.
51 2021-04-07 pain in extremity Body aches; headache; joint pain; sore arm; tiredness; This is a spontaneous report from a contactab... Read more
Body aches; headache; joint pain; sore arm; tiredness; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation Solution for injection,lot number: EN9581, Expiration Date: not reported), via an unspecified route of administration in left arm on 05Feb2021 10:45 as single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]), omeprazole (OMEPRAZOLE), clarithromycin (CLARITIN [CLARITHROMYCIN]), acetylsalicylic acid (BAYER ASPIRIN) taken for an unspecified indication, start and stop date were not reported. On 05Feb2021 the patient experienced body aches, headache, joint pain, sore arm and tiredness. The outcome of the events was reported as recovered on an unspecified date in Feb2021.
51 2021-04-07 tingling 5 minutes after 1st shot (administered in left arm) my face turned red, about 20 minutes later I fel... Read more
5 minutes after 1st shot (administered in left arm) my face turned red, about 20 minutes later I felt a prickly feeling in my cheeks and ended up with a rash on both cheeks that was gone by next day. Felt very run down/tired. 2nd does (3/20/21) felt prickly feeling in cheeks ended up with a rash on both cheeks that lasted 2 days. Felt very run down/tired for 3 days. Rash cleared 1 week after.
51 2021-04-07 tingling Pt became light headed and dizzy 25 minutes after vaccine administration, 40 minutes after vaccinati... Read more
Pt became light headed and dizzy 25 minutes after vaccine administration, 40 minutes after vaccination reported feeling heat and tingling on L side of face, neck and arm.
51 2021-04-07 seizure like phenomena Pt was walking towards waiting area. Pt was falling to floor with nurse breaking her fall. Pt plac... Read more
Pt was walking towards waiting area. Pt was falling to floor with nurse breaking her fall. Pt placed on backside with head lifted. Family at side. Pt started displaying seziure activity. Placed on left side with head guarded. EMS was notified at this time. V/s obtained with b/p 168/98 HR 80 98% O2. Pt agreed to leave with EMS at this time. A/Ox3. Left with family at her side.
51 2021-04-07 tremor Within 10 minutes of receiving first dose of Pfizer covid vaccine began to have "shakiness, lighthea... Read more
Within 10 minutes of receiving first dose of Pfizer covid vaccine began to have "shakiness, lightheadedness, dizziness and fast heart rate". States that she has a history of anxiety and believes it is that. Initial VS of BP 180/100, HR130, RR 18, O2Sat 100%. Patient was observed for ~40 minutes, given water, juice and position of comfort (sitting) with only had mild improvement of symptoms in that she felt her heart wasn't racing. Repeat VS BP 180/88, HR 90, RR 18, O2sat 100%. EMS called and patient was transported to Hospital ER for further evaluation/treatment.
51 2021-04-08 weakness Chills, nausea, and weakness. Shot was in the morning, symptoms started late afternoon, worsening in... Read more
Chills, nausea, and weakness. Shot was in the morning, symptoms started late afternoon, worsening in the evening and overnight. Felt a little better in the morning.
51 2021-04-08 difficulty speaking 51 year old female patient, with a history of migraines and eczema, presents to ED with complaints o... Read more
51 year old female patient, with a history of migraines and eczema, presents to ED with complaints of an allergic reaction. Approximately ten minutes after receiving her first Pfizer COVID-19 vaccination dose at the Vaccination Clinic (around 4:20 PM), patient developed swelling to her tongue, mild hoarseness of her voice, and very mild shortness of breath. Patient was not given any medications while in the vaccination clinic and was brought into the ED immediately. She only has one known medication allergy to Percocet. Patient has no other associated symptoms including cough, wheezing, chest pain, nausea, vomiting, diarrhea, or rash. She has no other pertinent past medical history. There are no other medical complaints at this time.
51 2021-04-08 flushing Systemic: warm and sweaty face--hot face-Mild, Systemic: Flushed / Sweating-Mild, Additional Details... Read more
Systemic: warm and sweaty face--hot face-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt waited a half hour--vitals were monitored by nursepractioner---122/78 hr in 80s---pt was walked out to car with husband waiting by employee---total dose benadryl 50mg--chewable and then liquid--pt immediately felt better after laying down--Np feels it was vasovagal
51 2021-04-08 hot flush, feeling cold first symptom began about and hour after injection . I felt hyper and it last until about 8pm when... Read more
first symptom began about and hour after injection . I felt hyper and it last until about 8pm when I began to experience a very bad headache and body pains. I was unable to sleep that night, experiencing hot and cold flashes and joint, and muscle pain intensified. By the next morning I was running a fever of 100.9. I continued to have extreme body pain, headache, and fever between 100.5 and 100.9 until Friday, March 26, 2021
51 2021-04-08 pain in extremity, weakness, unresponsive to stimuli Got shot in right arm. Sat in waiting area and within 5 - 7 min felt sick and faint. Dropped to the ... Read more
Got shot in right arm. Sat in waiting area and within 5 - 7 min felt sick and faint. Dropped to the floor and I could not move. I heard people wanting to sit me up to get me in a chair but I could not move on my own. They lifted me and then I went out completely. I remember dreaming and then within seconds, that is what I was told, I could hear them. I then was taken to an area that they checked my pulse, BP, and sugar. Blood pressure, I believe was around 92. I usually run around 120 but can run lower. They called an ambulance because I was unresponsive for a bit while on the floor. I was given IV fluids because of concern with BP. I was aware the rest of the time. I felt nauseous, shaky, cold, thirsty, and very weak. I went to the hospital and they did a CBC and differential as well as a chest xray. All were very good. They also did an EKG which was ok. I started to feel better and the doctor said I could drink and since I felt hungry and had a small protein bar. I was discharged around 12:15p. I continued to feel very weak, some nausea, some diarrhea and a slight headache. I woke in the morning very dizzy and off balance with a sore arm, a little nausea and weak. On 4/8/21 I woke up feeling very weak in my limbs. Headache, sore arm and nausea were gone. By the end of the day the weakness was a bit improved. By 4/9/21 the weakness in my limbs was much better. Still get a little dizzy if I bend over.
51 2021-04-08 pain in extremity, tingling I got the shot on Satruday and then that evening, my arm was sore as expected. I had a little someth... Read more
I got the shot on Satruday and then that evening, my arm was sore as expected. I had a little something under my eye. Looked like a little bite. On Sunday, on my face I had what looked like sunburn under each of my eyes and on the side of both of my face. It felt tingly. The redness was there day into Sunday night. I took some Benedryl. On Monday, the red was gone but my eyes were puffy and had some swelling to my face and still had tinglng in my face. I called my PCP and she asked that I come in and see her. On Monday, I had a visit with my PCP, there was stil some swelling around my eyes. She was going to report it and would let me know if I could take DOSE 2. I was advised to not take DOSE 2. It was all better by Wednesday.
51 2021-04-08 pain in extremity COVID arm; redness, soreness, warmth
51 2021-04-08 tingling, pain in extremity tingling in right arm and leg, pain in left arm and leg, weakness in left arm and leg, swollen right... Read more
tingling in right arm and leg, pain in left arm and leg, weakness in left arm and leg, swollen right side of face, chest pain, and fatigue
51 2021-04-08 tingling Pt reports that she started feeling fussy in the head and her left arm started tingling. Pt also re... Read more
Pt reports that she started feeling fussy in the head and her left arm started tingling. Pt also reported an odd taste in her mouth. Pt reports that she has had a busy morning seeing her chiropractor and having a massage and has not drank any water for hours. Pt was given water to drink and symptoms resolved.
51 2021-04-08 tremor, tingling slight tingling in hands and feet, off and on shortly after vaccination. tingling and muscle tremor... Read more
slight tingling in hands and feet, off and on shortly after vaccination. tingling and muscle tremor in left cheek 12 hours after vaccination
51 2021-04-08 tremor diarrhea; muscle aches; sweating and shaking from fever; shaking; sweating; Severe 5 day headache; s... Read more
diarrhea; muscle aches; sweating and shaking from fever; shaking; sweating; Severe 5 day headache; severe joint pain in hands and elbow; severe chills; This is a spontaneous report from a contactable 51-years-old non-pregnant female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 17Feb2021 at 14:00 as single dose in left arm for covid-19 immunization. The patient's medical history was not reported. Historical vaccine included bnt162b2 on 27Jan2021 for covid-19 immunization (administration time=04:00 PM, vaccine location=Left arm, dose number=1). Concomitant medications included levothyroxine sodium and amlodipine besilate. The patient took Codeine in the past and had allergies. On 18Feb2021 at 16:00, the patient had severe 5-day headache, severe joint pain in hands and elbow, severe chills, sweating and shaking from fever, diarrhea, and muscle aches. The patient's laboratory details included covid-19 virus test with negative results on 17Feb2021. The patient did not take any treatment for the events. The outcome of the event was not recovered. Information on the lot batch number has been requested.
51 2021-04-09 pain in extremity Temp of 100.4 off and on for 24 hours; Sore arm; Slight redness; Chills; Headache; Tiredness - slept... Read more
Temp of 100.4 off and on for 24 hours; Sore arm; Slight redness; Chills; Headache; Tiredness - slept for 20 out of 24 hours post injection; This is a spontaneous report from a contactable Other HCP (patient). A 51-year-old (non-pregnant) female patient received BNT162B2 (Solution for injection, Lot number: EL9265) via unknown route of administration on 03Feb2021 at 10.45 AM first dose at right arm, single dose for COVID-19 immunisation. The patient's medical history included Covid (prior to vaccination). The concomitant medications were not reported. On 03Feb2021 at 09:00 PM, patient experienced sore arm, slight redness, chills, headache, tiredness (slept for 20 out of 24 hours post injection) and temperature of 100.4 off and on for 24 hours. The patient did not receive any treatment for the events. The outcome of the events was recovering.
51 2021-04-10 weakness, numbness, tingling Immediately after the shot (within 8 minutes) I had a metallic taste in my mouth, followed by a numb... Read more
Immediately after the shot (within 8 minutes) I had a metallic taste in my mouth, followed by a numbness and tingling spreading from my face to my neck and ears. My whole left arm hurt and left side of my body is weak. Two hours later, I have chills, body pains, exhausted, and have a horrible headache. I have taken ibuprofen and Tylenol.
51 2021-04-10 burning sensation After about 5 minutes I got extreme burning on left arm, Then my throat felt restricted, difficult... Read more
After about 5 minutes I got extreme burning on left arm, Then my throat felt restricted, difficulty breathing and rapid heartbeat. My left arm had hives with mild redness. My blood pressure shot up to 138/85. I walked back in from waiting in my car and taken into clinic to be observed for about 30-40 minutes. My symptoms did calm down and mostly resolve after 30 minutes. Due to reaction my 2nd dose scheduled for 4/9/2021 was declined as it was in a non-clinical setting. Was advised to go to a hospital for 2nd dose since doctor was concerned I may get a stronger anaphylactic reaction. I am getting seen by my PCP since I have been having dizziness and heart palpitations since the 1st dose. However not sire if related or not. I do want more information whether I should even get the 2nd dose or not.
51 2021-04-10 numbness, tingling Tingling and numbness from the bottom of my neck to the top of my head on the left side and the top ... Read more
Tingling and numbness from the bottom of my neck to the top of my head on the left side and the top 1/4 of my head on the right side. Numbness in my mouth and on the top of my tongue, but it did not affect my breathing or ability to speak. Swelling and tightness of my left cheek. The numbness/tingling lasted for 2-3 hours. The swelling lasted for about 3 full days. My mother called the Board of Health who said I should lay down. It helped. When I sat up, it started to spread again, so I laid down for about one hour. I later contacted my physician to see if I should get the 2nd shot.
51 2021-04-10 nerve pain I had s these symptoms after both shots:fever, headache, flu symptoms, swelling all over including e... Read more
I had s these symptoms after both shots:fever, headache, flu symptoms, swelling all over including eyelids, joint pain. On 4/11, 11 days after second shot I developed burning/stinging nerve pain throughout body. Went to ER. All tests normal except my abdominal lymph nodes are swollen. Only mild pain relief with morphine. Being referred to a neurologist. Have never experienced this before. Only history of nerve damage is an injury in right foot. In extreme pain with no explanation yet.
51 2021-04-10 pain in extremity Intense arm pain that radiates up and down my arm still after a full month. My left side is still so... Read more
Intense arm pain that radiates up and down my arm still after a full month. My left side is still sore and the pain feels like it?s between my arm pit and breast on the left side which was the side I got the shot.
51 2021-04-10 pain in extremity Started with headache, arm soreness and right hip ache ( artificial hip joint) on Friday, sneezing a... Read more
Started with headache, arm soreness and right hip ache ( artificial hip joint) on Friday, sneezing a lot and itching on Saturday and now on Sunday right shoulder and Neck are so sore that I want to stay in bed, but I can't because we have a week to move!
51 2021-04-10 tremor, tingling after first dose I had mild tingling, rapid heart and a sense of restricted air passage and breathin... Read more
after first dose I had mild tingling, rapid heart and a sense of restricted air passage and breathing. I took benedryl 45 mins after injection and symptoms passed. after second dose i immediately felt tingling, rapid heart and panic. I took benedryl immediately. at 30 minutes (had already left vaccination site) I felt an intense reaction through my body -- I was shaking and tingling and feeling like my air passages were restricted. we drove to the emergency room but by the time we got there the sensation had subsided. maybe effects of benedryl. i did not go to the emergency room.
51 2021-04-11 weakness I has my injection on the 8th at 10:30 am and started feeling nauseous about 2:30 pm... then had a ... Read more
I has my injection on the 8th at 10:30 am and started feeling nauseous about 2:30 pm... then had a watery diarrhea episode about 3:30 pm... felt okay after that but then it came back later that evening and continued nonstop until the morning of Sunday the 11th. Continuous nausea and watery diarrhea as soon as I?d take a sip of anything. I finally took Imodium Saturday night but that did nothing. Felt lethargic and weak all of Sunday the 11th. Feel much better on Monday the 12th.
51 2021-04-11 burning sensation, difficulty speaking, cold sweat, pain in extremity, numbness, tingling 4/5/2021; 02:20pm: Onset of symptoms. Burning, tingling, numbness in injection site left arm, moved... Read more
4/5/2021; 02:20pm: Onset of symptoms. Burning, tingling, numbness in injection site left arm, moved to back of shoulder blades, neck, hand/fingers and to right arm and facial and head. Extreme dizziness. Brain fog, difficulty swallowing but no swelling, rash or hives. Evening of 4/5 and all day 4/6 had arm soreness and mild headache that subsided after 2 days. 4/6-4/11: dizziness/lightheaded, blood pressure fluctuation - systolic and diastolic high, difficulty swallowing on 4/9 and 4/10 - felt like something stuck in middle of throat, voice hoarseness, slight sore on right side of throat. 4/11: Cold sweat while sleeping 4/12: Lightheaded (mild), blood pressure fluctuation (not as high as previous readings), voice hoarseness, slightly sore on right side of throat. Mild/light tingling at right shoulder blade and back of neck.
51 2021-04-11 burning sensation, trigeminal neuralgia, facial pain Trigeminal neuralgia - bouts of shooting jabbing pain on upper part of left cheek lasting about 30 s... Read more
Trigeminal neuralgia - bouts of shooting jabbing pain on upper part of left cheek lasting about 30 seconds to 1 minute (spontaneous - not from any contact) usually precipitated by burning feeling. Resolved with taking Advil. Still present the next morning (i.e., morning of 4/12) - again responded to Advil. Pain has dissipated but evolved into chronic, dull ache in same area. No visible rash, or sign of any kind of palsy. Only affects left side (nothing on the right).
51 2021-04-11 cold sweat, numbness Patient is a 51 year old female who has not completed a 30-minute observation period due to the foll... Read more
Patient is a 51 year old female who has not completed a 30-minute observation period due to the following signs and symptoms of an adverse reaction starting @ 1054: swelling of tongue and lips, body numbness, clammy skin, syncope, shortness of breath, hypertension, and tachycardia (see VS flowsheet for values). Pfizer-BioNTech COVID-19 vaccine # 1 in series administered @ 1035. Action(s) taken: @ 1056 Epinephrine administered and Transferred to higher level of care post RRT @ 1105. Allergy to COVID-19 vaccine documented in Allergies activity: Yes Patient and husband advised to discuss second dose considerations with a clinician and obtain refill for Albuterol and Epinephrine.
51 2021-04-11 cold sweat PT REPORTED ON 4/12/21 THAT DURING THE 15 MINUTE WAIT SHE WAS EXPERIENCING CHEST PAIN AND ELEVATED H... Read more
PT REPORTED ON 4/12/21 THAT DURING THE 15 MINUTE WAIT SHE WAS EXPERIENCING CHEST PAIN AND ELEVATED HEART RATE. HER HUSBAND TOLD HER IT WAS HER ANXIETY. ABOUT TWO HOURS LATER SHE DEVELOPED DIZZINESS AND COLD SWEARS. SHE IS ALSO EXPERIENCING LYMPH NODE PAIN.
51 2021-04-11 numbness Numb right arm from elbow to fingertip, heaviness in arm, stinging like a bee sting
51 2021-04-11 muscle twitching light headed, sleepy, muscle twitching, fainted. Monitored and resolved in 60 min.
51 2021-04-11 tingling, hot flush Began having the sensation of being poked with needles all over my body. Continuously. Like a se... Read more
Began having the sensation of being poked with needles all over my body. Continuously. Like a severe tingling. Head to toe, including face and extremities. ( With the 1st dose, I had the same sensations on a very slight level, and only on arms and legs and not all the time). Sensations started day 2. Severe at day 4, when I had to drive 4 hours to another State. Accompanied by random dizziness, and feeling mentally "out of it" a little. I'd read it was Ok to exercise after getting the shots, so Day 2 and 3 I attempted crossfit. I got thru the classes, barely. Afterward I thought I was going to pass out and I felt bizarre, mostly my head. Very unwell. I would also get random hot flashes with dizziness. I am perimenopause, but dont have hot flashes very much any longer and they dont make me dizzy. With the day 4 severity of the needles sensation, I honestly started to worry. I decided Id see a doctor upon my return to home, which would be day 7. Today is day 7 after dose 2. Huge improvement, but still having some of the sensations, so I dont plan to reach out to my doctor unless my next workout feels like the ones last week. I expected the common side effect of tiredness and fever chills, but got this crazy stuff that felt like my nervous system was misfiring/freaking out. I am afraid to get a booster shot for Covid if that's the path in a few months!
51 2021-04-12 weakness At 12:28 p.m. on Saturday, April 10, my blood oxygen went down to 87%. I felt cold, had chills, and ... Read more
At 12:28 p.m. on Saturday, April 10, my blood oxygen went down to 87%. I felt cold, had chills, and was shivering. I felt weak and felt malaise when i stood up. I was monitoring my blood oxygen and temperature. Blood oxygen improved but I still felt malaise, weakness. I took one 600 mg ibuprofen at 2:40 p.m. At around 3:43 p.m. my blood oxygen was 98% and i felt better finally. Subsequently, I took 2 (200 MG) Advils at 9:50 p.m. before going to sleep. At 2:00 p.m. on Sunday, April 11, I got up to get my salad out of the fridge and I started feeling malaise. My heart rate went up, I was breathing shallow. I drank 2 Advils (400 MG). I took 1 more ibuprofen at 3:30 p.m. I felt bad until before going to sleep. Before going to sleep, I drank chamomile tea to help me breathe better and took 3 Advils. At around 8:00 p.m. on Monday, April 12, I started to experience shallow breathing. I made myself chamomile tea and drank two cups but it didn't seem to help shallow breathing. I then made myself a tea with ginger, turmeric, cayenne pepper, black pepper, lemon peel, lemon juice, coconut oil and honey. I drank it around 11:25 p.m. I was up until after 12 a.m. until finally I felt I could breathe better and went to sleep.
51 2021-04-12 flushing My shot was given in my left arm and the right side of my face became flush and slightly swelled - t... Read more
My shot was given in my left arm and the right side of my face became flush and slightly swelled - treated with benadryl
51 2021-04-12 tingling, numbness, speech disorder Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general ... Read more
Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general malaise; fatigue; difficulty concentrating; Day 2: General malaise, fatigue; difficulty concentrating; headache; lower back pain Day 3: Fatigue; runny nose, sneezing, cough, aches all over the body; headache; a red, itchy blotch on the right index finger; lower and upper back pain Day 4: Same as above, but vision problems right before bedtime; Day 5: Severe headache, lightheadedness, difficulty talking, numb left side of thCT e face, left hand, left arm, left food. Went to ER and still in the hospital in observation (Day 6)
51 2021-04-12 tingling 10 minutes after the patient received her vaccination, she experienced a tingling sensation on the l... Read more
10 minutes after the patient received her vaccination, she experienced a tingling sensation on the left side of her abdomen. When she stood up, she experienced a sharp pain on the right side of her abdomen. The tingling sensation lasted ten seconds and the pain lasted a brief moment (a second or two). She denies constipation or diarrhea.
51 2021-04-12 unresponsive to stimuli 51 y/o female with syncopal episode following vaccination. Per witness pt suddenly fell out of the c... Read more
51 y/o female with syncopal episode following vaccination. Per witness pt suddenly fell out of the chair. Pt unresponsive about 15-20 secs. Per pt she started to have headache and suddenly fell to the floor. Pt has Hx of hypotension and depression. VS stable writer called emergency transport and husband. Pt requested to be sent to ER. Nurse attempted to get pt med list from husband and he was unable to locate it at the time but stated that he would bring list to ER. EMS present at the time of incident, monitored pt until Fire & Rescue arrived.
51 2021-04-13 bell's palsy Bell's Palsy Left Side of Face
51 2021-04-13 bell's palsy New ones in addition to previously reported: Bell?s Palsy right face jaw and neck New nodules bright... Read more
New ones in addition to previously reported: Bell?s Palsy right face jaw and neck New nodules bright red on fifth digit left hand never had before Contacted my primary care physician and she wanted to just observe and gave no treatment center take ibuprofen for the pain
51 2021-04-13 burning sensation April 6-10 extreme fatigue April 10 to current left arm burning skin sensation sensitive to touch ai... Read more
April 6-10 extreme fatigue April 10 to current left arm burning skin sensation sensitive to touch air and light. Doctor appointment suspected Shingles. Extremely painful
51 2021-04-13 cold sweat patient reports lightheaded and nauseous and clammy after vaccine.
51 2021-04-13 discomfort First, I had a tight throat and I blamed it on the pollen, next at home potato chips got stuck in my... Read more
First, I had a tight throat and I blamed it on the pollen, next at home potato chips got stuck in my throat, and I was just like 'I am eating too quickly', then at boy scout meeting that evening I couldn't breath and blamed it on my mask (we have to wear masks outside), came home took an expired Benadryl and thought, I will call allergist in the morning for an appointment. Next day woke up, felt fine then around 1pm I was on the toilet and I felt a drop like hitting the bottom on the elevator and I thought I won't be able to get off the toilet, I felt super dizzy and nauseous and I thought I would fall. I seriously don't think I have ever felt worse. Yelled to husband got on sofa and started calling 'ask a nurse' which was stupid, called 911 and they told me to take epi-pen which I should have known to give myself the whole time! EMT came and I went to ER. Felt better almost immediately with epic-pen and drip with steroids and Benadryl. Next day went to allergist and felt like I was having another reaction, she gave me some additional meds. I started on Zyrtec and I didn't like how drowsy I was feeling so on 4/5 I didn't take Zyrtec that night and Tuesday I woke up fine and then around 1pm I thought I was going to die, I called the allergist, they said you should continue taking Zyrtec every night and take one then. I felt like I was having another allergy attack. I felt so dizzy I couldn't move, I felt like I was going to fall, I threw up. I was still too dizzy to move, called ER, went to ER and started feeling better due to the Zyrtec now in my system.
51 2021-04-13 feeling hot sudden feeling of dizzyness. started by feeling wobbly, just something that felt "off". within an ho... Read more
sudden feeling of dizzyness. started by feeling wobbly, just something that felt "off". within an hour i felt like my balance was off. standing and sitting didn't feel quite enough, started to feel that hotness and start of naseau, but laying down to left side and then sitting up seemed like a head rush. then within maybe another 20 min, definite dizzyness. when looking up to the ceiling, visibly looked like world spinning. but not as visible looking down. no change in vision though. felt okay to lie down and sleep. pretty intense for a couple of hours. but better by morning. worked from home as usual. felt mildly wobbly when moving around fast or animated. all gone by 6pm/supper. ate fine all day. drank fine.
51 2021-04-13 feeling of body temperature change, pain in extremity I submitted a report after my first dose of the vaccine , and now this is the report after my 2nd do... Read more
I submitted a report after my first dose of the vaccine , and now this is the report after my 2nd dose of the Pfizer vaccine: I got the 2nd dose at 4:10pm. I did not feel the shot at all this time, but my arm was a bit achy soon after. One hour after the shot my leg muscles hurt and I felt fatigued. Two hours after the shot I felt really tired and really silly, kind of loopy. Three hours after the shot my L arm was hurting more and it hurt to take the band aid off. Then my stomach started feeling upset. I went to bed at 10:30pm and had a very rough sick night. I was awake most of the night, only dozing a few times. I had a fever (101) and chills; nausea and belching; dry mouth; aching and strange pains coming and going; a slight headache; and my L arm was hurting. By 7am I started crying, and I had more physical pain. I got up at 8am feeling so sick with extreme fatigue, headache, and in a lot of pain in body. My Mom had to make my breakfast for me and I took small bites of that oatmeal throughout the day. I couldn't eat very much because my stomach was so upset. I felt hot and cold and got chills often during the day. By 6:45pm the fever returned (100.3) and I felt sicker again with head and tummy hurting; body aching; and nausea. Finally at 8pm I took 2 Tylenol which helped a lot, but then I worried what if that reduced the effectiveness of the vaccine. I went to bed at 9:15pm and fell asleep right away, but woke up many times soaking wet with sweat. The next day I still had trouble with temperature regulation and I felt very tired and headachy and my L arm still hurt. A few days later I got my menstrual cycle about one week early, and it was the strangest period I've ever had. It was a very light flow, I had lots of clots, and along with the small amount of blood, there was lots of clear stretchy mucous like I get at ovulation. After my first vaccine dose I got my period a few days later also, but that time I only had brown spotting for 4 days and no regular blood flow at all, so this time it was slightly more of a period, but it was really not my usual kind of period. Overall, I felt completely whacked and wrecked by the 2nd dose. It was a terrible experience.
51 2021-04-13 hot flush, night sweats 1. Swollen left underarm on shot arm presumed to be swollen lymph nodes. Did not go to Doctor. P... Read more
1. Swollen left underarm on shot arm presumed to be swollen lymph nodes. Did not go to Doctor. Pain also in shoulder blade as if lymph nodes swollen there also. Lasted over a week. 2. I was going through early stages of menopause. Hot flashes, night sweats, stopped ovulating, haven't menstruated in 8 months. Since the 2nd shot, about 5 days post vaccination, I have not had a single hot flash or night sweat. I also ovulated and it is to be seen if it brings my menstrual cycle back. Not a bad event, just thought it may be needed to be known if some women are on hormones, etc, as it may affect that.
51 2021-04-13 pain in extremity Lump in arm, redness, looks like there is a sore in that spot, entire arm is constantly in pain and ... Read more
Lump in arm, redness, looks like there is a sore in that spot, entire arm is constantly in pain and throbbing
51 2021-04-13 pain in extremity sore arm 1:42 pm, severe headache 2:20 pm, heat on arm 2:25 pm, nausea 7 pm, fatigue 7pm
51 2021-04-13 tingling, feeling cold, flushing Lightheaded, L sided chest pain, Feeling cold flushing, feet tingling Tx: vs, monitored - taken to E... Read more
Lightheaded, L sided chest pain, Feeling cold flushing, feet tingling Tx: vs, monitored - taken to ED in ED at 3:35pm - motrin/tylenol, Fluids Rest 1/21 allergic and adverse reaction not allergic 1/26- 2ND dose given- no adverse reactions
51 2021-04-13 unresponsive to stimuli Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional D... Read more
Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: 6 days after dose patient had a syncopal attack and severe palpitations. Daughter called ambulance after finding mother had fainted.
51 2021-04-14 bell's palsy Bell's Palsy on the right side of the face - 12 TENS and 7 Laser Therapies - slow improvement durin... Read more
Bell's Palsy on the right side of the face - 12 TENS and 7 Laser Therapies - slow improvement during first month
51 2021-04-14 feeling cold I woke at 3am freezing had to put winter clothes and 5 blankets. I had a fever of 101. It's 140pm an... Read more
I woke at 3am freezing had to put winter clothes and 5 blankets. I had a fever of 101. It's 140pm and I do feel alot better but I definitely got something from the first shot 2 days ago.
51 2021-04-14 feeling hot, tingling Client (DOB: 2/19/1970) received the 2nd Pfizer COVID vaccine lot # EW0162 and expiration date 4/18/... Read more
Client (DOB: 2/19/1970) received the 2nd Pfizer COVID vaccine lot # EW0162 and expiration date 4/18/21 at approximately 2:53PM. Client reported to nurse that she wanted her temperature checked because for her first dose she had experienced tingling, neck pain and flushing. PHN asked how client felt and client reports she feels way better than the first dose but still experiencing mild tingling in right arm. Client reports feeling warm and that she had already waited 25 minutes and did not want to wait much longer because her husband was waiting in the car and he is a doctor. PHN took clients vitals: oxygen: 99%, blood pressure: 118/82, and pulse: 85. Client reports that her neck also hurts just like last time but less: pain 4/10. PHN advise client tell her PCP and gave emergency precautions. Client did have redness in her right hand and PHN offered Benadryl but client reports she wanted to leave. PHN had Lead PHN double check client before she left. PHN spoke with client. At this time client stated feeling fine. Mild redness noted on right hand. Client denied pain, full sensory and motor function. Per client ready to leave. At 3:30 pm client left facility with a steady gait.
51 2021-04-14 flushing, cold sweat, feeling hot client complained of dizziness after receiving 2nd dose of Pfizer Covid Vaccine. Within 2 mins of re... Read more
client complained of dizziness after receiving 2nd dose of Pfizer Covid Vaccine. Within 2 mins of receiving vaccine client informed RN she was feeling dizzy. Client able to transfer by herself from chair to wheelchair. RN pushed chair to observation room where EMT assumed care. PHN joined EMT. Client alert and oriented. Per client feeling warmth, dizzy, dry mouth. Vitals at 1434: blood pressure: 110/80, pulse 86, oxygen 98%. Medical history: diabetes, COPD, bipolar depression, glaucoma, and retinopathy. EMT gave client water. Current medications: latuda, metformin, timolol, travatan, eyedrops, novalog, basaglar, and jenuvia. Per client did not have any reaction to first dose. Client informed we would continue observing for 30 mins. 1439 client stated dizziness was improving. 1443 vitals: blood pressure: 130/80, pulse 85, oxygen 99%. Per client dizziness improving. 1448 vitals: blood pressure: 132/82, pulse 85, oxygen 100%. Client stated feeling warm again and clammy. PHN asked client to lower mask and assess skin color. Face flushed, client denies shortness of breath. Per client warmth feeling worsening, PHN offered Benadryl. Client stated not driving, insurance transport would take her home. 50mg Benadryl given orally at 1454. Vitals: blood pressure 126/80, pulse 83, oxygen 98%. Vitals 1500: blood pressure 124/82, pulse 81, oxygen 100%. Client stated feeling better. Still warm feeling, dizziness improving. 1505 vitals: blood pressure: 122/82, pulse 83, oxygen 98%. Per client more improvement, stated starting to "feel sleepy". 1510 vitals: blood pressure 120/78, pulse 87, oxygen 97%. Per client dizziness resolved, skin color back to normal, no flushing noted. ER precautions given. Transport arrived at 1530, unable to get last set of vitals. Per client feeling much better, client asked to be wheeled to transport car due to tired feeling. PHN and EMT accompanied client to bus. Client able to stand up from chair with no complaints. Able to walk into vehicle by herself with steady gait.
51 2021-04-14 migraine MIGRAINE, SUPER TIRED, LOW GRADE FEVER
51 2021-04-14 nerve pain Left arm felt hot and tingling to my fingertips. Achy, Fever of 103F, chills, tired for 2 days.
51 2021-04-14 pain in extremity Sore arm for three days and ongoing dizziness
51 2021-04-14 pain in extremity Sore Arm and Ear Ache. Woke with a very sore throat and very tired
51 2021-04-14 tingling Patient received first dose Pfizer vaccine (LOT#: EW0162 Exp: 7/2021) at 1556. Patients observation ... Read more
Patient received first dose Pfizer vaccine (LOT#: EW0162 Exp: 7/2021) at 1556. Patients observation time had passed. EMT asked patient if she was feeling well to leave. Patient stated that she felt a tingling feeling in her hands to her legs. EMT told PHN who asked patient to stay another 30 minutes for further observation. PHN offered patient diphenhydramine. Patient refused medication at 1634. EMT took patients vital signs. BP: 106/58, pulse: 65, 02: 98%. PHN assessed patient again. Patient stated that the tingling feeling moved to her face around 1642. PHN offered patient Diphenhydramine once again. Patient agreed to medication. PHN gave patient adult dose of Diphenhydramine 50mg/mL at 1643. Patient assessed after 30 minutes were up. Patient stated that the tingling feeling in her hands, legs and face had gone away at 1700. Patient was picked up by her cousin. Patient left vaccination site unassisted and with a steady gait.
51 2021-04-14 tremor Had an extremely high fever of 103.4 about 28 hours after the vaccine. Fever was not brought down by... Read more
Had an extremely high fever of 103.4 about 28 hours after the vaccine. Fever was not brought down by Motrin/Tyelenol. Also shaking chills.
51 2021-04-15 weakness, pain in extremity, numbness, facial paralysis, facial pain, coordination abnormal Pfizer dose #1 EJ1686 1/1/2021 12:30 pm Onset of symptoms 2 pm 1/1/2021, around 1.5 hrs post vaccin... Read more
Pfizer dose #1 EJ1686 1/1/2021 12:30 pm Onset of symptoms 2 pm 1/1/2021, around 1.5 hrs post vaccine: severe headache, stiff neck ache, dizziness, nausea, chills, extreme fatigue, feverish but below 100.4, severe muscle aches, loss of taste and smell. Loose bowels at times, slept all the rest of the day and night, drank lots of fluids and electrolytes (low sugar). Felt more weak and dizzy the next day, and when walking felt veering right more, more issues with extended activity. e next dose on 1/22 onwards, and has never gone away fully. R arm pain and raised, tender area at vaccine site contiued to hurt for weeks, even into the next dose on 1/22 onwards, and has never gone away fully. 1/3.2021 woke up 5:30 am sudden onset shortness of breath, deep lung pain in the center of the chest. I felt like my R lung blocked, and started to cough up large amounts of clear mucus, and vomiting mucus due to airway feeling blocked. I did a 4 albuterol puffs to try to open my airway, but I was not wheezing, and did not have any respiratory symptoms or illness at the time before this started. I had been having continued less lung capacity for many months prior due to having been very sick in March 2020 onwards, including loss of sense of smell and taste, shortness of breath, deep lung pain, fever, No wheezing, not sick. Pfizer dose #2 EL9261 1/22/2021 3:50 pm after work. Onset of symptoms by 5:30 pm with headache, dizziness, nausea, extreme fatigue, increased R arm pain at the vaccine site, but it was still hurting at the site from the 1/1/21 shot too, before this dose. Drank fluids and went to bed. Loss of smell and taste returned 1/23/21. Had continued bad headache from 1/22 onwards, with nausea and feeling more dizzy at times, and on 1/26/21 I was at work with increased headache, dizziness and nausea, and went home early from my shift (I am an RN) due to symptoms. Went to bed early, due to continued nausea and headache and dizziness at times. 1/27 continued bad headache, then in the afternoon around 3 pm, GI felt bloated, bad nausea, and then felt shortness of breath around 4 pm and faster heart rate in the upper 80?s lasting for minutes, despite laying down in bed, so I too used my oximeter (I Have photos) and the sats were staying at 88% continuously, and had shortness of breath and return of deep internal mid lung pain, and this lasted for over 10 min. I used a canister of Boost oxygen for 5-6 puffs to try to recover, and the sats raised to 90%. No wheezing. Not sick. I had a bad headache and nausea, and was not feeling good and went to bed. On 1/28/21 I woke up at 5:30 with severe vertigo and dizziness, nausea and a bad headache and could not walk due to the vertigo, and vomited when I was trying to have my head up. I had to crawl to the bathroom on my hands and knees. I called out sick for work due to this and contacted my DR. I was started meclizine 25 mg 3 times a day for vertigo, and was taking Zofran to help. 1/31/21 noted my Re upper eyelid was doing a lot of spastic twitching at times, that would stop and start, but did not think about it much. The vertigo was unrelenting and then I started to have Right arm and hand weakness noted on 2/3/21 and was still very dizzy, nauseated and had a constant headache since I got dose #2 of the COVID vaccine on 1/22. I was using a walking stick for the dizziness to be stable, and also felt weaker on the R side, and drifting to the right when walking .On 2/4/21 I had my first MRI (no contrast, unfortunately) and noticed I could not fully shut my Right eye in the MRI, and by 2/5/21 my face was drooping. I still had the constant headache, nausea and dizziness, and increased R hand, arm and R leg weakness and R hip weakness. I could not lift my R leg up to walk well, cannot grip well with the R hand, and uncoordinated, and cannot walk straight, and am unstable when trying to walk heel to toe, or even stand still with my eyes shut, and have had some double vision with the R eye. I was started on Prednisone and on Klonopin for the vertigo on 2/9 after seeing my neurologist. I took Prednisone for 5 days, from 2/9-2/13 and did not have improvement with the R facial droop or R side weakness and the headaches have persisted, along with some dizziness and nausea. on2/14-15 I had increased shortness of breath and R lung felt like it was not inflating much, and got an xray, and went onto Zithromax for 5 days, which did help my lungs to improve, and I was able to breathe better, and got my Right lung capacity back. I stopped the Klonopin after a week (2/9-2/16), to manage through the symptoms without it, and have been doing physical therapy and. Vestibular therapy. I had another MRI, with contrast on 2/25, after an in-person neurology appointment, and was having some improvement with the vertigo, so I started back to a desk job, not my RN job on 3/4/21, but I was still having the constant headache, nausea, and some dizziness, R face droop, R hand weakness, R leg weakness and walk with a walking stick, and have increased issues with exertion, but have been walking and doing therapies to get stronger.3 I started to have increased R facial droop. EMG done on 3/23 of my R arm. Worse headache, nausea, dizziness at the desk, and fatigue, but R side weakness issues increased, so I started back onto Prednisone on 3/28/21 with 50mg day for 3 days, then 40mg for 3 days, 30mg for 3 days then 230mg for 2 days, but had increasingly bad headache,nausea and increasing R facial droop, and much worse R hand weakness, R arm weakness and pain, and R hip pain and weakness, worse walking, cannot lift my R leg or foot as high as the L, again, and am struggling to walk, and get worse with exertion with R side walking and weakness. I also had shooting pains in my R jaw start on 4/6-7, along with R jaw and face pain and increased numbness, more face droop shooting pains in my R hip, and arm and body pain and a worse headache making it hard to even sleep, and some increased issues with my R eye that I need to have checked. The prednisone last dose was on 4/7, and stopped due to the symptoms I was having, after a video visit with the neurologist. Increased R leg weakness, R weak hip vs left, R foot drag/drop, with increased issues to maintain walking with progressive walking, still using walking stick to try to walk, but now for stability and to keep from drifting, R facial droop increasing and now some R eye blurring 4/9 onwards, that is new.
51 2021-04-15 breast pain Experienced arm pain at injection site starting about 12 hrs after shot. About 24 hrs later, felt a... Read more
Experienced arm pain at injection site starting about 12 hrs after shot. About 24 hrs later, felt armpit pain on same side so likely swollen lymph nodes? Took ibuprofen evening of 4/9 with some relief. Now have dull pain left breast area/armpit a week later.
51 2021-04-15 cold sweat, tingling, feeling cold Clammy, tingling in bilat hands, anxiety. Pt stated she fainted before - feels cold, clammy beforeha... Read more
Clammy, tingling in bilat hands, anxiety. Pt stated she fainted before - feels cold, clammy beforehand. She felt this way w/ bilat tingling & called for nurse. A&O x4. Vitals stable. Gave water - hasn't drank since 10 AM. After drinking water, pt stated she is feeling better. Offered w/c for exit, declined. Vitals still stable. Pt left Yahoo in stable condition. BP 123/63; HR 72; RR 18, SpO2 97%
51 2021-04-15 feeling cold I developed a headache across my forehead around 8:30pm that night 4/15/21 from 12:10pm vaccination.... Read more
I developed a headache across my forehead around 8:30pm that night 4/15/21 from 12:10pm vaccination. I didn't take any medication. I applied peppermint essential oil with no relief. The headache was still present in the morning now with nausea from the headache. I do not normally get headaches. I took pamprin at 7:30am 4/16/21 and ate breakfast. The headache has dissipated, however I feel it in the background and I am very cold. My temperature is 98.2. I am no longer nauseous. My atlas was out of alignment so I was adjusted by a chiropractic clinic. I will await to see if my headache returns or for other symptoms and take pamprin if necessary again.
51 2021-04-15 numbness Patient reports that her symptoms started within 5 minutes of getting the vaccine. Started with fac... Read more
Patient reports that her symptoms started within 5 minutes of getting the vaccine. Started with facial numbing then followed by a bad headache and joint pain all happening within 15 minutes. Facial numbness was her first symptom that started. In the next hour she had chills, scratchy throat, itchy and dry eyes. Slept the rest of the day. The following day she had headaches, chills terrible body aches. 4/12/21 she developed facial swelling under her chin, lymph nodes inflamed/enlarged, chills, body aches, slight headache, cough. Took IB to help with symptoms. She still continues to have side effects today, (4/16/21) which include body aches, fatigue and still "not feeling right."
51 2021-04-15 pain in extremity she had a low grade fever of 99.5 degrees; body ache; felt feverish, but had no fever; Back pain; sh... Read more
she had a low grade fever of 99.5 degrees; body ache; felt feverish, but had no fever; Back pain; she said she had pain in her arm, and the pain went away after the first day; This is a spontaneous report from a contactable other health Care Professional. A 51-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EL1284) via an unspecified route of administration in right deltoid on 26Jan2021 at 10:30 as single dose for covid-19 immunisation. Medical history included anxiety. Concomitant medications included on 27Jan2021 at a dose of 50 mg once a day for anxiety.On26Jan2021,the patient experienced on pain in her arm, and the pain went away after the first day, body aches, particularly severe back pain and feeling feverish on 29Jan2021, she had a low grade fever of 99.5 degrees on 31Jan2021, treatment received for this events with she took Tylenol and Motrin and this morning she felt better. The patient underwent lab test included body temperature Body temperature 99.5 Fahrenheit. The outcome of the events pyrexia was unknown and for pain in extremity was resolved, body ache, feeling abnormal, back pain was not recovered.
51 2021-04-15 pain in extremity Loose BM, pounding headache, body aches, nausea, fatigue, sore arm, chills , eyes hurt-sinus.
51 2021-04-16 weakness Patient was very dizzy about 10 minutes after vaccine was administered. She was very weak and was sl... Read more
Patient was very dizzy about 10 minutes after vaccine was administered. She was very weak and was slumping down on the chair. I helped her to the floor. Her blood pressure was low. She was not unconcious and was able to answer my questions. Her husband was in the store and came to help her as well. I gave her water and a protein bar. EMS arrived to take her. She did not want to go at first but agreed to go with them.
51 2021-04-16 pain in extremity, tingling Parked car after injection which was painless. Pain at wrist and tingling in hand. Right arm from w... Read more
Parked car after injection which was painless. Pain at wrist and tingling in hand. Right arm from wrist to scapula swollen and in pain. Pain at neck and couldn't tell if swollen. Lasted through the next day. Persistent right hand tingling lasted over 24 hours. Had to use left hand to type for work.
51 2021-04-16 pain in extremity Pain in the arm, whoever gave me the shot recommended me tylenol. However, I still have pain in the ... Read more
Pain in the arm, whoever gave me the shot recommended me tylenol. However, I still have pain in the arm.
51 2021-04-16 pain in extremity High fever (101.9 by thermometer) and Swollen painful lymph node approximately an hour after the vac... Read more
High fever (101.9 by thermometer) and Swollen painful lymph node approximately an hour after the vaccine. Now the lymph node is larger and my arm is swollen?pain radiates from my left armpit down-past my elbow and towards my chest muscle.
51 2021-04-16 tingling Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt stated left hand ... Read more
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt stated left hand tingling kept pt for 30 minutes when left she stated she felt much better hardly noticeable called at end of shift left message
51 2021-04-17 weakness Rcvd injection at 10 am, 10:05 am rapid heartbeat, dizziness, weak. Sat down. 10:20 am heartbeat st... Read more
Rcvd injection at 10 am, 10:05 am rapid heartbeat, dizziness, weak. Sat down. 10:20 am heartbeat steadied, still a little disoriented but able to leave facility. 10:25am, left side of face swelled up. 10:30 am, in bed, slept for 3 hours, profuse sweating. Upon waking up, tired, swollen left side of face, headache, sore throat, injection site and other muscle pain. Back to bed 8pm, same symptoms. Sunday morning the 18th 8 am drenched with sweat, injection site pain, swollen left side of face. By noon, after taking daily medications and shower, cold compress on left side of face, swelling down, still feeling tired, but overall feeling better.
51 2021-04-17 feeling cold About 7 hours post injection, I started experiencing general increasing discomfort and almost unbear... Read more
About 7 hours post injection, I started experiencing general increasing discomfort and almost unbearable heat at the injection site. In addition, I started feeling light-headed and had loud ringing in my ears. I was able to move to a chair and sit down, and a family member provided me with a cold pack to place on my arm. Eventually, the ringing in my ears subsided and I no longer felt like I was going to pass out. This episode lasted for about 20 - 30 minutes. I was chilled for the remainder of the evening on 4/17.2021. Today (4/18/2021), I have had periods of light-headedness, but not nearly as severe as yesterday.
51 2021-04-17 muscle twitching Muscle twitching daily starting day-of or day after shot. Day 1 was left quad and right tricep. Anot... Read more
Muscle twitching daily starting day-of or day after shot. Day 1 was left quad and right tricep. Another day was groin and calf. Each day since, and night, various muscles, including gluts, quad, calves, triceps, both thumbs, groin, left eye I have had several incidents where muscle tightened like a Charlie Horse, usually at night but did not get very painful, and possibly restless leg one night but could have just been a lot of twitching in my leg. Now it has been over 2 weeks and it continues. I'm uncertain whether to get round 2. The twitching doesn't last too long but it does seem to be more frequent and more lasting. My thumbs just keep twitching. Very concerning.
51 2021-04-17 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
51 2021-04-17 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Tachycardia-Medium, Additional Details: 6 days a... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Tachycardia-Medium, Additional Details: 6 days after vaccine
51 2021-04-18 discomfort Pt received dose 1 of Pfizer vaccine on 4/15/21 at approx. 3:46pm at a clinic due to past allergies.... Read more
Pt received dose 1 of Pfizer vaccine on 4/15/21 at approx. 3:46pm at a clinic due to past allergies. While being monitored for 30 minutes post vaccine, pt complained of slight wheeze, pain in throat and tongue feeling heavy. Only visible sign was small red blotches on upper chest. BP was 159/95, pulse 75 and pulse ox was 97%. 25 mg Benadryl po given at approx. 4:16pm. Pt remained at clinic to be monitored. At 4:50pm, patient left with husband feeling much improved: throat pain gone, wheeze gone, tongue feeling normal, swallows easily and red areas on chest visible, but diminished in size. Patient called on 4/16/21 and no further complaints. Felt much improved once home and no further symptoms. Encouraged to let staff know about incident when receiving dose 2 and to stay longer than 30 minutes for monitoring.
51 2021-04-18 flushing 43 hours after vaccination, began to experience: metallic taste in mouth, burned feeling lips, flush... Read more
43 hours after vaccination, began to experience: metallic taste in mouth, burned feeling lips, flushed skin on face, chest and neck, slight headache and nausea.
51 2021-04-18 muscle spasms, tingling Started getting tingling in right thigh followed by tingling in left lower leg & left foot. Severe m... Read more
Started getting tingling in right thigh followed by tingling in left lower leg & left foot. Severe muscle cramps in left calf. Intermittent tingling in both upper arms. This was followed by blurry vision in the left eye & intermittent dizziness.
51 2021-04-18 pain in extremity Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Ton... Read more
Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: leg pain-Mild, Additional Details: pt complained of fatigue, hives over upper half of body starting the day after vaccination and leg/thigh pain starting two days after vaccination
51 2021-04-18 pain in extremity Fever began around 9:30 pm and continued off and on through around 11pm the next day. Pain in finge... Read more
Fever began around 9:30 pm and continued off and on through around 11pm the next day. Pain in fingers, toes and back. Headache unlike a normal headache or migraine . There was a dull constant pain everywhere, but also shooting pains on the sides of my head. A great deal of fatigue and general achiness.
51 2021-04-18 pain in extremity Sudden onset of lower leg ( shin area) pain similar to a Charlie Horse. Lasted approximately 7 hours... Read more
Sudden onset of lower leg ( shin area) pain similar to a Charlie Horse. Lasted approximately 7 hours. Diarrhea for 2 days
51 2021-04-19 migraine I received the second vaccine at approximately 10:45am on 4/19/21 at pharmacy; later that afternoon ... Read more
I received the second vaccine at approximately 10:45am on 4/19/21 at pharmacy; later that afternoon a very bad migraine started do develop, which I did not take medication for as I want to ensure nothing would interfere with the vaccination doing it's job. The pain of said migraine has traveled to different locations in my head between 4/19 through the morning of 4/21 - from the base of the back of the head and neck area to the top/left of the skull and over left eye area. On 4/20/21 at 10:05am, I developed a very unpleasant ringing in both ears that I am very concerned about as it is exacerbating the migraine and is extremely painful.
51 2021-04-19 night sweats Legs swelled up and turned red. Leg swelling was so bad I couldn?t put my shoes on for one week afte... Read more
Legs swelled up and turned red. Leg swelling was so bad I couldn?t put my shoes on for one week after the shot and it didn?t return to normal for a few weeks after the shot. I also had night sweats beginning the night I received the Pfizer shot and they have continued - every night, since that time and currently have them. I also had moderate to severe pains in my hips, low back and legs more so, but all over my body it was painful in my muscles. This has not completely gone away. My strength in my legs and back was also less and created a limitation in my walking- I normally walk 10,000 steps everyday, but have to stop every 3,000 steps and sit down because of the pain and reduced strength in my hip and back. had headache and mild coughing, but that went away.
51 2021-04-19 seizure Pt received her first pfizer covid vaccine at 1519 in R delt. Approx 9 minutes later patient began h... Read more
Pt received her first pfizer covid vaccine at 1519 in R delt. Approx 9 minutes later patient began having a seizure. Patient's 3 children were present and getting their vaccine that day as well. They informed staff she had a history of seizures. Patient was moved from chair to the ground in a laying position on her left side. RN was called immediately into the room. Her first seizure was approx 6 minutes long and the shortest was 45 seconds. Patient had 4 seizures in approximately 17 minutes prior to EMS arriving. No meds were administered in clinic.
51 2021-04-19 trigeminal neuralgia Tight chest, cold tight in throat and chest, swollen lips, headache, flared trigeminal neuralgia sym... Read more
Tight chest, cold tight in throat and chest, swollen lips, headache, flared trigeminal neuralgia symptoms
51 2021-04-20 numbness, bell's palsy Pt informed nurse that her lips felt "numb" directly after receiving vaccine. Pt stated that one wee... Read more
Pt informed nurse that her lips felt "numb" directly after receiving vaccine. Pt stated that one week later she developed pain and numbness toleft side of her face starting from behind her ear, then also started behind her right ear. On 4/4/2021 Pt went to the ER as pain and numbness had not gone away and was dx with Bells Palsy. Pt was started on antibiotics, steroids , and Ibuprofen. On 4/7/2021 Pt went to see PCP at gateway, He informed pt to go home and continue medication regime. Then pt states pain became worse because ibuprofen is no longer working. 4/15/2021 @1755, pt was advised to f/u with PCP tomorrow, or to go to urgent care/ER if symtoms do not improve in the next 24 hours. Pt/Spouse verbalized understanding.
51 2021-04-20 pain in extremity, bell's palsy Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; c... Read more
Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; chills; tongue swollen; no taste; This is a spontaneous report from a contactable consumer (patient). A 51-year-old (also reported as 52-year-old) female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 51-years-old, administered in Arm Left on 10Mar2021 10:45 (Lot Number: EN6202) as single dose for COVID-19 immunization. Medical history included asthma and high blood pressure. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced "Bell palsy", pain in arm, pain in neck, headache worsen from center of head to neck, dizzy, nausea, chills, tongue swollen, no taste; all on 19Mar2021 22:30. Description was as follows: "pain in arm, neck, headache, dizzy, nausea, chills and then days later other symptoms, headache worsen from center of head to neck, neck hurting, tongue swollen, no taste, and then woke up with Bell Palsy and was taken to the emergency room". Therapeutic measures were taken as a result of Bell palsy. The outcome of the events was recovering. The events were considered as serious (Disability or permanent damage/ Disabling/Incapacitating). The adverse events resulted in any Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. More information has been requested.
51 2021-04-20 pain in extremity, feeling cold, weakness All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pa... Read more
All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pain; I had some wired nausea, I can even hardly eat; I had some wired nausea, I can even hardly eat; My heart rate is kind of low but it's been 125 for last 2 days; I have a rash; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; My lymph nodes are very swollen; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have been passed out; I had mine my fever gone up to 104.9 and down to 103; my arm is swollen, hard and hurts terribly; my arm is swollen, hard and hurts terribly; whole arm get deep red; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in the left arm on 01Apr2021 (Batch/Lot Number: EN6199) (at the age of 51 years old) at a single dose for covid-19 immunisation. Medical history included lupus and high blood pressure both from an unknown date. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonazepam (KLONOPIN) and topiramate (TOPAMAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 12Mar2021 (lot number: EN6198) (at the age of 51 years old) and reported that she was really not feeling well. On 01Apr2021, the patient got the second dose of covid vaccination and reported that she had a pretty serious side effect since the first one. The patient then reported her fever gone up to 104.9 and down to 103 and reported that she was worried about herself, not only the fever; her arm is swollen, hard and hurts terribly; patient reported that all her muscles and whole body is hurting and the chills, the joint pain of course the fever and further reported that had some wired nausea, she can even hardly eat. The patient then stated that within a few hours after her shot, she started having mild problems: swelling of her arm, her whole arm get deep red and throughout pain in her arm. The patient had a video call with her primary care doctor, the doctor said it's just normal, don't worry about it, the doctor didn't let the patient give all her symptoms (as reported). The patient further stated she have that pain and something is not right in her body and that she have been taking Tylenol. The patient also reported that her heart rate is kind of low but it's been 125 for last 2 days (as reported), patient reported that she has a rash, feel dizzy and weak, cannot stand up and walk, the patient have attended to go for her family house for the Easter and she was there for 15 minutes. Keep in mind Covid normally they all were vaccinated and it's been a very special time, but within 15 minutes the patient have been passed out and had been taking home and further reported that her lymph nodes are very swollen and her head is killing her. The patient have an electric blanket in her arm because she have chills so bad, her joints are hurting and she have ray nods (as reported) also that's circulation disorder and she feel like she have been freezing cold ever since she got the second shot. The outcome of the events was unknown.
51 2021-04-20 tingling Client c/o tingling of mouth and face. No distress note at the moment. Client able to voice concer... Read more
Client c/o tingling of mouth and face. No distress note at the moment. Client able to voice concerns. Client seen by EMT. No v/s obtained. Client instructed to contact PCP or go to ER if symptom worsen and cleared to go by EMT.
51 2021-04-21 feeling hot I started feeling dizzy, and then later on i had the worst headache for 2 days and it felt like i wa... Read more
I started feeling dizzy, and then later on i had the worst headache for 2 days and it felt like i was catching a cold, i got really hot, and was and still very sluggish after the second day. My chest also felt very tight and body aches, i feel terrible.I couldn?t even get out of the bed to use the bathroom and a little runny nose.
51 2021-04-21 feeling jittery, restless legs syndrome Nervousy feeling all over my body, but in legs mostly.
51 2021-04-21 grand mal seizure, seizure Ariived to find 51 year old female actively seizing whiling prone on the floor. Pt was convulsing co... Read more
Ariived to find 51 year old female actively seizing whiling prone on the floor. Pt was convulsing consistent with grandma seizure . Patience skin colour was normal and maintained her own airway without assistance. Pt skin color was normal and maintained her own airway without assistance. Patients breathing Was rapid but sufficient. Pt became postictal on the floor . Pt began seizing a 2nd time . Pt was rolled into left lateral position Pt was lifed on to the stretcher, began seizing for the 3rd time . pt was tf into the ems room. Pt became posticsl and began to recovering an had an increasing level of awareness. Pt states she had a hx of anxiety driven seizure and her lastbone was about a month ago. Pt vs were evaluated. Pt declind transport to ed against medical advice.
51 2021-04-21 numbness The patient went to urgent care on 4/7 complaining of back pain that was "sharp" and would sometimes... Read more
The patient went to urgent care on 4/7 complaining of back pain that was "sharp" and would sometimes numb her foot. She was told to take ibuprofen/Tylenol. The patient went to the emergency room on 4/10 complaining of the same pain. Was given an injection that helped. Went to the emergency room again on 4/22 complaining of the same back/leg pain. The patient states this all started after receiving her first covid vaccine on 3/20. She returned on 4/17 (one week late) for her 2nd dose.
51 2021-04-21 pain in extremity, weakness nauseous, vomiting, dizziness, weakness, left arm hurts,
51 2021-04-21 tingling, numbness Paraesthesia (numbness and tingling) started in upper back, arms and hands. Numbness was worse at n... Read more
Paraesthesia (numbness and tingling) started in upper back, arms and hands. Numbness was worse at night particularly in right arm. As weeks since first dose of COVID-19 vaccine, numbness and tingling experienced over entire body. The numbness and tingling waxes and wanes. Neurology consult on 7 April and started on gabapentin 300 mg nightly. MRI was conducted on 21 April and was normal. Blood work on 7 April and immunoglobulin G, A, and M and all were normal. Methlymalonic acid was normal.
51 2021-04-22 mild one side paralysis LEFT SIDED WEAKNESS, TIA
51 2021-04-22 hot flush, muscle spasms Extreme headache and fatigue, pain in arm where shot was given, leg cramps, chills and hot spells b... Read more
Extreme headache and fatigue, pain in arm where shot was given, leg cramps, chills and hot spells but, no fever.
51 2021-04-22 numbness Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facia... Read more
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Pain Numbness of arm right after injection and afterwards, arm and collarbone neck back area
51 2021-04-22 numbness 30 min after injection-itchiness all over, especially face, numb sensation, continuing to next morn... Read more
30 min after injection-itchiness all over, especially face, numb sensation, continuing to next morning, administered Allegra, and around 14 hrs after vaccination, additional symptoms of nausea, dizziness, stomach pain, chills, achy joints
51 2021-04-22 muscle spasms Painful body and joint cramps aches fingers arms hands legs feet toes neck hips shoulders. Mild he... Read more
Painful body and joint cramps aches fingers arms hands legs feet toes neck hips shoulders. Mild headache. Stomach nausea. Very tired
51 2021-04-22 muscle spasms Fever, nausea, leg cramps, dizziness, headache, tired
51 2021-04-22 pain in extremity Symptoms started about 24 hours after vaccine and lasted only one day. Excruciating Leg pain, headac... Read more
Symptoms started about 24 hours after vaccine and lasted only one day. Excruciating Leg pain, headache, fever, nausea, chills, fatigue, pain down arm and where shot was given. I had covid in late December and these were also some but not all of the same symptoms.
51 2021-04-22 pain in extremity The day after my shot I woke up with extreme joint pain; mostly throughout my leg, ankles and toes,... Read more
The day after my shot I woke up with extreme joint pain; mostly throughout my leg, ankles and toes, as well as my hips. Stairs were extremely painful. By Sunday 4/4 the pain had subsided. Around 4/6, I noticed raised red bumps all over my elbows which turned to white patches forming over them within a day or so. After seeing the dermatologist 4/13, she informed me it was psoriasis which could also lead to psoriatic arthritis. (Seems like what I felt 4/3). She prescribed Mometasone cream to be used 2x a day for the rash. The bumps still remain today 4/23 but have diminished slightly and lost the white patch on them. This past week starting around 4/19, my arm and shoulder (of the arm I received the shot in) has had a dull ache 24/7, seemingly muscular.
51 2021-04-22 pain in extremity 51 years old female called to report an adverse reaction after receiving her first P-fizer vaccine o... Read more
51 years old female called to report an adverse reaction after receiving her first P-fizer vaccine on 04/15/2021 @1500. patient reported on 04/16/2021 @0800 she developed pain in bones, feet, hands, and arms, patient also reported headach, chills, fever, patient reported sulfa allergies, patient reported that she takes levothyroxine for low thyroid level and amlodipine for high blood pressure. patient was instructed to take tylenol and benadryl to help with the symptoms. patient was instructed to seek medical attention if the symptoms got worse.
51 2021-04-23 weakness Unusual and debilitating physical weakness, chills. Lasted a day.
51 2021-04-23 feeling of body temperature change, weakness, tremor Coughing, body, muscle and joint aches, chills, headache, hot/cold, legs shaky, not able to hold hea... Read more
Coughing, body, muscle and joint aches, chills, headache, hot/cold, legs shaky, not able to hold head, weakness
51 2021-04-23 hot flush Hot Flashes/headache Pt observed for 30 mins 2 sets of vitals taken along with 02. all normal pt im... Read more
Hot Flashes/headache Pt observed for 30 mins 2 sets of vitals taken along with 02. all normal pt improved and was discharged home in a stable condition. no medications given
51 2021-04-23 pain in extremity shortness of breath; Headache; tightness in the chest; sore arm; This is a spontaneous report receiv... Read more
shortness of breath; Headache; tightness in the chest; sore arm; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: em9810) via an unspecified route of administration in left arm on 20Feb2021 at 14:30 as single dose for COVID-19 immunization. The patient medical history included sports induced asthma and had allergies to Tramadol, Morphine, Propoxyphene, Ciprofloxacin, Topiramate, Povidone-Iodine, Metformin, Hydrocodone. The patient previously received the first dose of bnt162b2 (Lot number: el3249) via an unspecified route of administration in left arm on 30Jan2021 at 15:00 as single dose for COVID-19 immunization. Concomitant medication received in two weeks includes vitamin D3 and levothyroxine. The patient did not receive other vaccine in four weeks. The patient did not had COVID prior to vaccination. The patient was not tested for COVID post vaccination. On 21Feb2021 at 16:00, the patient experienced headache, tightness in the chest, shortness of breath and sore arm. The patient did not receive treatment for the events. The outcome of the events was recovering.
51 2021-04-23 pain in extremity Was unable to work two days, 04/19-20 as was very bad. Duration 2 days: Fever 102.5, worst headach... Read more
Was unable to work two days, 04/19-20 as was very bad. Duration 2 days: Fever 102.5, worst headache ever, worst chills ever, pain all over, extreme difficulty standing up from a laying down position, nausea, vomit one time, dizzy off balance, unable to sleep more than 30 minutes at a time, could not cope with any sound or lights, and diarrhea. 24 hours after second shot had to take Motrin since so bad. Duration 4 days: fatigue and arm pain. Diarrhea is back today, 6 days after second shot. The poop is skinner than normal, with diarrhea and the color is lighter than normal today. I have not seen a doctor, I just want to report since it was so bad, and I am very anxious about these being annual shots and not sure when to worry about the diarrhea.
51 2021-04-23 pain in extremity Sore arm, swollen lymph nodes under left arm, metallic taste in mouth, 101 degree fever, chills, mus... Read more
Sore arm, swollen lymph nodes under left arm, metallic taste in mouth, 101 degree fever, chills, muscle aches, headache
51 2021-04-23 pain in extremity Fever 102, severe weakness in wrists and hands primarily. For about 8 hours. This started at 7pm. Co... Read more
Fever 102, severe weakness in wrists and hands primarily. For about 8 hours. This started at 7pm. Could not hold a cup or cell phone to text family. I have no prexisting issues with the arms hand or wrists and never experienced. 10pm fever spiked again with very loud ring in ears. On a scale of 1-10 if was an 8. Almost passed out twice earlier on 04/23around 10am. Extreme fatigue like more than I ever experienced before. Could not stay awake for conversations. I did have the usual arm and neck pain and body aches but I kind of expected those. I still have a low grade fever at 1154am on 04/24 while I'm typing this so my wrists are back to normal.
51 2021-04-24 weakness tired; weak; This is a spontaneous report from a contactable consumer who reported for his wife (pat... Read more
tired; weak; This is a spontaneous report from a contactable consumer who reported for his wife (patient). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unwon route for Covid-19 immunization. Medical history included autoimmune condition, Type 1 Diabetes Mellitus, Graves Disease (hyperthyroidism), some eczema. Patient got the diabetes later in life like 6 years ago from having her immune system compromised. Patient was perfectly healthy. Concomitant drugs included levothyroxine sodium (SYNTHROID) and insulin. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. After the shot, patient was tired and weak for a couple of days. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-04-24 weakness 1st shot: 3/31/2021- within 5 minutes drenching sweat, rapid heartbeat, dizziness; in the evening b... Read more
1st shot: 3/31/2021- within 5 minutes drenching sweat, rapid heartbeat, dizziness; in the evening body aches 2nd shot: 4/22/2021: fatigue, body aches, chills, fever, headache, loss of taste and smell, weakness
51 2021-04-24 burning sensation Extremely swollen lymph node on collar bone. Tender and fire with movement.
51 2021-04-24 pain in extremity Sore arm for 3 days; For the two weeks after receiving the vaccine, I would have recurring injury pa... Read more
Sore arm for 3 days; For the two weeks after receiving the vaccine, I would have recurring injury pain for 24-36 hours in prior injury sites (wrist, shoulder, allergic bite on back, wrist again). One site at a time with a day of no symptoms in-between. Symptoms stopped occurring exactly two weeks from vaccination. Some pain strong enough that ibuprofen needed.
51 2021-04-24 tingling, numbness, bell's palsy Bell's Palsy; something felt weird; asthma; facial numbness and tingling; facial numbness and tingli... Read more
Bell's Palsy; something felt weird; asthma; facial numbness and tingling; facial numbness and tingling; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration administered in arm left on 05Apr2021 (Batch/Lot Number: ER8727) at age of 51 years old as single dose for covid-19 immunisation. There was no medical history. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No events following prior vaccinations. There were no concomitant medications. The patient had her 1st dose of Pfizer Covid-19 vaccine on Monday morning (05Apr2021). The patient experienced facial numbness and tingling on 05Apr2021. After the injection she sat and waited for 15 minutes. When she got in the car, she felt her face tingling. It had been a couple days of having the sensation in her face. She called her physician and it was labeled as Bell's Palsy. Her physician suggested she phone and report her experience. She had her appointment at 11:30. She was back in her car around 13:00. She noticed as she was driving, that something felt weird. She didn't know if it was numbness or tingling. She added it was not painful and she was not distorted. She thought it's numb. Her physician advised she take Motrin. Her physician shared an article about a trial that some people may experience this after, it included 4-5 people. Her symptoms shifted. First in her cheeks, then over the course of yesterday and today, she feels it's on the side of her face. The forehead had gone away, but it's on the right side of her face. She added the symptoms were improving and clarified they were persisting. She had asthma and wanted to minimize the severity of Covid if she would ever get it. She had loved ones around and added that you never know. She wanted to protect herself. She wanted to get out and see her family and friends. Some of them have already been fully vaccinated. She was concerned when it started. It wasn't affecting her breathing, but she called her physician and asked if she needed to come in. Her physician suggested to just monitor it. The events did not require visit to emergency room or physician office. The outcome of events facial numbness and tingling was not recovered. The outcome of other events was unknown.
51 2021-04-24 tingling soreness around injection site later in the evening; fingers were a little stiff for about an hour a... Read more
soreness around injection site later in the evening; fingers were a little stiff for about an hour after vaccination; Tingling sensation passed through arm down to fingers within 15 minutes of dosing; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm at the age of 51-year-old on 07Apr2021 13:00 (Batch/Lot Number: ER8734) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included hypertension, asthma, dust allergy, mold allergy, pollens allergy, Environmental allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant. Concomitant medications included lisinopril; salbutamol (ALBUTEROL HFA); budesonide, formoterol fumarate (SYMBICORT); fexofenadine hydrochloride (ALLEGRA); ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS); fish oil. Tingling sensation passed through arm down to fingers within 15 minutes of dosing on 07Apr2021 13:15; fingers were a little stiff for about an hour after vaccination on 07Apr2021 14:00; soreness around injection site later in the evening (7 pm) on 07Apr2021 19:00; mostly resolved by next morning. Therapeutic measures were taken as a result of events (Took Excedrin night of vaccination prior to sleeping). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was reported as recovering. No follow up attempts are needed. No further information is expected.
51 2021-04-24 seizure, unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe
51 2021-04-24 tenderness Systemic: Reporting area of discoloration on chest, sensitive to touch-Mild.
51 2021-04-25 weakness Entire left shoulder area is extremely painful after second shot. Arm cannot dangle; it must always ... Read more
Entire left shoulder area is extremely painful after second shot. Arm cannot dangle; it must always be in propped position. Pain reliever, whether oral or topical, does not work. Hot nor cold compresses do not work. There is marked weakness and range of motion present. Unable to lie on back or side at night while attempting to sleep. Extreme tiredness began on second day after first vaccine with lower fever.
51 2021-04-25 burning sensation I experienced an outbreak of hives on my legs, feet, arms, hands, and ears. I took Benadryl to minim... Read more
I experienced an outbreak of hives on my legs, feet, arms, hands, and ears. I took Benadryl to minimize the itching and burning of them. I first noticed them when I was showering on my lower legs on the morning of April 23rd. They flared up the most on April 24th for about a 24 hour period and begin to subside on April 25th and 26th. They are still present but slowing diminishing.
51 2021-04-25 feeling hot, facial paralysis Within 15 or 20 minutes of receiving her first dose of the Pfizer Covid vaccine, the patient, felt h... Read more
Within 15 or 20 minutes of receiving her first dose of the Pfizer Covid vaccine, the patient, felt hot and asked for a fan. She started to feel like she was going to faint and said that her mouth felt funny. She was breathing without difficult. The patient eventually had a syncopal episode and then had facial drooping.. When she regained consciousness, she could communicate and answer questions. Breathing remained normal and pulse rate was in the 50s. EMS was called when the patient said that she felt faint. They took her to to the hospital for further treatment.
51 2021-04-25 numbness I first had extremely dry mouth within minutes after shot.I felt a slight tightening of my throat bu... Read more
I first had extremely dry mouth within minutes after shot.I felt a slight tightening of my throat but wasn't to concerned to alert staff. 30 minutes after shot and after left facility the whole interior and exterior of nose, sinus cavity and checks went numb. All symptoms subsided within an hour.
51 2021-04-25 throat numbness throat numbness, lip and tongue swelling
51 2021-04-25 sensory loss, tingling 20 hours after injection temperature started to rise. 23-24 hours after injection loss of sensation ... Read more
20 hours after injection temperature started to rise. 23-24 hours after injection loss of sensation and tingling in finger tips left arm, lasted about 45 minutes. 26 hours after injection fever topped at 102.4 30 hours after injection starting to feel better again. 42 hours after injection fully recovered, only slight headache left, that lasted all day
51 2021-04-27 difficulty speaking Immediately after injection it felt as if My throat was being choked & my throat started to burn ...... Read more
Immediately after injection it felt as if My throat was being choked & my throat started to burn .... it lasted for about an hour.... after I was left with a horse sore throat & my esophagus hurt.... it still is hurting ....
51 2021-04-27 numbness Left arm numbness 2-3 days after 1st shot (administered in right arm) Period 2 weeks late after 1s... Read more
Left arm numbness 2-3 days after 1st shot (administered in right arm) Period 2 weeks late after 1st dose, started after 2nd dose twice as heavy as usual and three times more clots with sized twice as big, still bleeding. Slight itching in the neck and upper shoulder area with very small raised bumps 1 week after second shot
51 2021-04-27 pain in extremity, breast pain, weakness, burning sensation, discomfort ongoing AE started 4/26 and continues through today (4/28); 4/26 around 11:30pm Unable to sleep due... Read more
ongoing AE started 4/26 and continues through today (4/28); 4/26 around 11:30pm Unable to sleep due to extreme discomfort. Contemplated going to hospital. Fever: temperature reached 101.9 with severe body aches (joint and muscle). My normal body temp is 97.2. Heart racing; Whole body: extreme fatigue and weakness, bouts of sharp pain in legs and back; Near shot location: extreme soreness in arm with limited range of motion in arm. 4/27: Fever: continued to have temperature above 101 with severe body aches (joint and muscle). After I took Tylenol at 1:00pm, temp dropped to 100.3. My normal body temp is 97.2. Heart racing; Whole body: extreme fatigue and weakness, Arms feel like they are burning; Near shot location: an additional symptom of soreness and pain in left armpit and breast. and pain shooting down my left arm; loss of appetite; 4/27: Repeat of 4/26 with exception that temp holding steady at 100.3 (with Tylenol)
51 2021-04-27 pain in extremity, numbness, paralysis Woke up middle of the night with bilateral arm numbness/paralysis and then shooting pain on both a... Read more
Woke up middle of the night with bilateral arm numbness/paralysis and then shooting pain on both arms and neck. Lasted up to 5 minutes. Next day -- pain in both hands and periods of bilateral arm numbness. Following evening woke up in the middle of the night with bilateral arm numbness/paralysis and pain shooting up fingers to shoulders in both arms and neck. Pins and needles on spine and arm and bilateral hand pain and numbness followed for 27 days.
51 2021-04-27 pain in extremity, tremor The first two weeks after I got the second dose of the Covid-19 vaccine I had pain in my knuckle of ... Read more
The first two weeks after I got the second dose of the Covid-19 vaccine I had pain in my knuckle of my left hand and I could not bend my left middle finger. After the two weeks, I had discomfort in the same area for one or two weeks. On February 20th, my right hand started shaking and I lost strength in both of my hands and arms. I went to the doctor and did an EMG, and the test results came back as normal. On March 31st, I had sharp shooting pain in my right thumb. On April 27th, the pain in my left hand middle finger knuckle came back and it hurts when I touch it and bend the finger. Aside from these symptoms, I still continue to have chills which I started having after I was infected with Covid in late November.
51 2021-04-27 tremor Facial swelling (eye, tongue, lip), high BP, high HR, shaking, lower O2 (95), monitored for over an ... Read more
Facial swelling (eye, tongue, lip), high BP, high HR, shaking, lower O2 (95), monitored for over an hour while hooked up to BP machine and pulse oximeter, epi was brought out and kept nearby but not administered. Continued for several hours after I got home. Also had severe uterine cramping for about 12 hours even though I am in menopause.
51 2021-04-28 weakness dizziness, weakness, heart rate elevated, incapacitated, shortness of breath, lethargic, brain fog
51 2021-04-28 feeling hot Reaction was immediate Dizzy Blurred vision Nausea Body felt very warm and overheated Heavy feelin... Read more
Reaction was immediate Dizzy Blurred vision Nausea Body felt very warm and overheated Heavy feeling and pressure in chest when breathing Overall uneasy feeling
51 2021-04-28 pain in extremity, bell's palsy Bell Palsy; sever leg pain; This is a spontaneous report from a contactable nurse (patient). A 51-ye... Read more
Bell Palsy; sever leg pain; This is a spontaneous report from a contactable nurse (patient). A 51-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm on 12Jan2021 (Batch/Lot Number: EL3246) as a single dose for COVID-19 immunization. Medical history was reported as none. The patient had no known allergies and no other medical history. The patient had no Covid prior vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 5730) in the right arm on 22Dec2020 at 11:00AM for COVID-19 immunization. The patient had no other medications in two weeks and no other vaccines in four weeks. The patient experienced Bell Palsy and sever leg pain on 28Mar2021. The patient was hospitalized for the events for 1 day. The patient was tested post vaccination. The patient underwent lab tests and procedures on 31Mar2021 which included Nasal Swab: negative. Treatment for the events included steroids and antiviral as well as antibiotics. The events had not resolved.
51 2021-04-28 pain in extremity On 4/25, redness to right arm around injection site, slight warmth. I placed moist warm compresses o... Read more
On 4/25, redness to right arm around injection site, slight warmth. I placed moist warm compresses on the site, took Ibuprofen. 100 temp. On 4/26, redness spreading across arm, very hot to touch. Continued Ibuprofen. Fever 102, goes down with ibuprofen. 4/27, no fever. Right arm has large area of dark red, pain to touch, hot to touch. 4/28, redness spreading toward axillary area with soreness and pain. Arm very hot to touch with red streaks. Physician assessed. Order for Clindamycin was given, cool and warm compresses for 5 minutes bid. To followup in 2 days if redness and heat has not decreased.
51 2021-04-28 tingling, numbness REACTION STARTED BETWEEN 10:15-10:30A, ALMOST IMMEDIATELY AFTER RECEIVING VACCINE. PATIENT HAS NUMBN... Read more
REACTION STARTED BETWEEN 10:15-10:30A, ALMOST IMMEDIATELY AFTER RECEIVING VACCINE. PATIENT HAS NUMBNESS AND TINGLING UP HER ARM WHICH EXTENDED UP TO HER FACE. EMTS WERE CALLED TO FACILITY TO EVALUATE PATIENT. PATIENT WAS CLEARED BY EMT AND ALLOWED TO DRIVE HOME.
51 2021-04-28 seizure, weakness, numbness Within 10 minutes of the shot I had a severe headache, numbness in my lips, feet and hands and was w... Read more
Within 10 minutes of the shot I had a severe headache, numbness in my lips, feet and hands and was weak and unable to walk without fear of falling. These symptoms continues for an hour, and while still weak I returned to work. I awoke the next day with a fever, body aches and fatigue that lasted 3 days. I have had 3 more bought s of severe fatigue since the shot and on Monday 4/26/2021 I suffered a seizure bi have no history nor symptomology of seizure activity, and was hospitalized for 2 days.
51 2021-04-28 tenderness Started having period , had light bleeding and spotting for 6 days, even though I am in Menapause an... Read more
Started having period , had light bleeding and spotting for 6 days, even though I am in Menapause and did not have bleeding for 2 years. Also have few purple spots on legs, somewhat painful when touching. Went for my routine check up to my gynecologist and mentioned it, she recommend it screening for cancer, did not think due to vaccination. Did not go to the doctor for purple spots, I am keeping an eye on them.
51 2021-04-29 cold sweat, tremor Sharp and tight pain in shoulder area between neck and upper shoulder on left side. Followed by an ... Read more
Sharp and tight pain in shoulder area between neck and upper shoulder on left side. Followed by an extreme spike in blood pressure and pulse rate. Also included a clammy sweating from forehead. Volunteer nurse took blood pressure. Top number rose over 185. Bottom number over 100. At one point 175/153. I?ve never had a high blood pressure health problem. Pulse was accelerated and heart began to palpitate irregularly. I laid down on reclining medical chair. Chest, neck, ears began to turn red. A few hives started to pop up. Nurse had me take 50mg of Benadryl. I was under observation by the staff for 2 hours. During that time my adrenaline accelerated and I began to shake sporadically. I continued to rest, drink water and eat crackers. I was sent home once blood pressure got to approximately 153/80.
51 2021-04-29 slurring, severe one side paralysis Patient s/p second Pfizer COVID vaccine 4/17/21. Presents to ED 4/28 with slurred speech & left hemi... Read more
Patient s/p second Pfizer COVID vaccine 4/17/21. Presents to ED 4/28 with slurred speech & left hemiplegia. CT imaging revealed R MCA CVA. Patient s/p thrombectomy for CVA. CT also had question of L transverse venous sinus thrombosis. On 4/29, patient went for MRI which confirmed multiple anterior and posterior circulation strokes and nonocclusive left transverse dural vein thrombus. Platelets at the time of presentation are normal. Heparin drip initiated 4/29 after consult with hematology (patient also high bleeding risk due to HHT). IF CT head stable 4/30, Patient will be transitioned to oral anticoagulation with close monitoring by hematology given bleeding risk.
51 2021-04-29 migraine Fever, chills, body aches, even with Tylenol. Had 102.5 temperature 6.5 hours after taking two Tyle... Read more
Fever, chills, body aches, even with Tylenol. Had 102.5 temperature 6.5 hours after taking two Tylenol, 36 hours after vaccination. Had 101.4 temperature 72 hours after vaccination and had taken 2 Tylenol 4 h ours previous to that measurement. Well into day 4 I was still running a fever but was in the 99s. By 72 hours, I also had a severe migraine with nausea. I finally had no fever 96 hours after vaccination and felt better but had another 12 hours of migraine. 108 hours later and I could leave the house.
51 2021-04-29 pain in extremity, feeling hot After receiving the shot, I was directed to the 30-minute wait section because I disclosed that I am... Read more
After receiving the shot, I was directed to the 30-minute wait section because I disclosed that I am highly allergic to sulfa. About 2 minutes after sitting down, I started having difficulty breathing and became very dizzy. It was if I could literally feel the vaccine rush through my body and even down into my legs. It felt like heat in my legs. I wanted to remove my mask to try to breathe, but I knew I should not. I am a single parent and my child was at home attending remote school so I was thinking I did not want to go to the hospital. I instantly prayed and paced my breathing as I struggled and began to sweat. I began slowly moving my legs because I started thinking about the J&J blood clot issues and prayed more. The ladies monitoring the section were at the front of my section and I was in the very back, so I could not alert anyone. I struggled and prayed about 10 minutes until my breathing improved (through prayer), but I was still dizzy. I sat there over 30 minutes because I was fearful to stand. I finally got up, but was still dizzy and lethargic. I called my mother and sat in my truck in the parking lot for another 30 minutes because I was not capable of driving. For approximately one week, I had tempered breathing, was very nauseous, fatigued, and lethargic. Interesting enough, I had only minor pain in my arm.
51 2021-04-29 pain in extremity stomach irritation; arm soreness; mild shortness of breath Normal vital signs; reassurance; monitori... Read more
stomach irritation; arm soreness; mild shortness of breath Normal vital signs; reassurance; monitoring total 60 minutes after vaccine; improved and released
51 2021-04-29 pain in extremity initially while driving home, eye spasms and eye dryness, various sharp pains in leg and right foot,... Read more
initially while driving home, eye spasms and eye dryness, various sharp pains in leg and right foot, a feeling of heightened anxiousness. Following day the typical fatigue, unusual headache, full tunnel feeling in head and ears, off balance feeling, some muscle aches as well as previously mentioned symptoms. this lasted for about 3 days. some mild relief in fatigue and headache but all of a sudden non stop ear ringing (Tinnitus) high pitched EEEEE with occasional low tone whistle sound. fast forward currently no relief in ear ringing and off and on mild pressure headaches, off balance,(some days worse than others) mild fatigue, some isolated off and on muscle aches. slight fainting feeling (occasional), don't feel grounded..... among other things
51 2021-04-29 tremor Drop in blood pressure, Respiratory Reaction, Dizziness, Nauseous, Nose Bleeding, tremors, headache... Read more
Drop in blood pressure, Respiratory Reaction, Dizziness, Nauseous, Nose Bleeding, tremors, headaches, fever, cognitive cloudiness, mobility issues, chills
51 2021-04-30 muscle twitching Fluttering twitches in lower arm and near knee Mild pulsing pain in back of head on 5/1/2021 at abou... Read more
Fluttering twitches in lower arm and near knee Mild pulsing pain in back of head on 5/1/2021 at about 7 am
51 2021-04-30 pain in extremity everything was spinning around me; lose balance; felt confused; light-headed/ dizzy; headache; pain... Read more
everything was spinning around me; lose balance; felt confused; light-headed/ dizzy; headache; pain in my arm; This is a spontaneous report received from a contactable consumer (reporting on herself). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration on 18Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took mercurochrome and experienced drug hypersensitivity. It was reported that she received the first dose of the BNT162B2 vaccine on Sunday (18Apr2021), that day she felt confused, light-headed, she had a headache and pain in her arm, but she considered that normal. At night, she woke up at 3 am (on 19Apr2021), she felt really dizzy, everything was spinning around her, she loose balance. she needed to go to the bathroom, but she had to walk holding herself in the walls, right now she still dizzy, she allergic to mercurochrome. Patient was 51 years old and asking when will it go away. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
51 2021-04-30 pain in extremity Significant gerd immediately following administrationsing; left arm and shoulder pain; left arm and ... Read more
Significant gerd immediately following administrationsing; left arm and shoulder pain; left arm and shoulder pain; This is a spontaneous report from a contactable consumer, the patient. A 51-Year-old (non-pregnant) female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203, Expiration date: unknown), via an unspecified route of administration in left arm on 27Feb2021 14:30 (at the age of 51-year-old) as single dose for COVID-19 immunization. The patient medical history included colitis ulcerative, fibromyalgia, premenstrual dysphoric disorder all from an unknown date and unknown if ongoing. Known allergies includes food allergy (lobster), contrast media allergy (contrast dye). Allergies to medications includes, drug hypersensitivity with ZIPACK, BACTRIM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medications were not reported. No COVID prior vaccination. Prior to vaccination, the patient has not been tested for COVID-19. On 27Feb2021 14:45 (at 02:45 PM) the patient experienced Significant GERD immediately following administration and left arm and shoulder pain within a couple of hours. The GERD was surprising not the arm and shoulder pain. The patient did not receive treatment for the adverse event. Since the vaccination, the patient has not been tested for COVID. Seriousness of the event was reported as non-serious. The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.
51 2021-05-01 feeling cold First shot on 04.02.21,...injection hurt (may have been result of person administering it). sore ar... Read more
First shot on 04.02.21,...injection hurt (may have been result of person administering it). sore arm at injection side Second shot on 04.30.21...injection itself not painful (person good at administering). , felt fine until 24 hours later. Hit me like a ton of bricks all of a sudden. Body aches everywhere, freezing cold (had heat blasting), fever all night of about 101.8. Took NyQuil with acetaminophen. Fever broke by 9:00am in morning. Still very achy.
51 2021-05-01 feeling hot Fever, chills alternating with being very hot, body aches, swollen area at injection site, no energy... Read more
Fever, chills alternating with being very hot, body aches, swollen area at injection site, no energy, loss of appetite
51 2021-05-01 pain in extremity Right away bad pain in arm, about an hour after I developed a metallic taste in mouth. Next day, inj... Read more
Right away bad pain in arm, about an hour after I developed a metallic taste in mouth. Next day, injection site is very swollen, headache, tired and metallic taste remains.
51 2021-05-02 hot flush ~20 hours after the 2nd vaccine I had muscle and joint aches which increased in pain until I took Ty... Read more
~20 hours after the 2nd vaccine I had muscle and joint aches which increased in pain until I took Tylenol (recommended by person who gave me the vaccine). Symptoms lasted about 48 hours. Feeling better today (Mon 5/3/21). Also having hot flashes, but may be contributed to my age.
51 2021-05-02 numbness STARTED OFF WITH BEING REALLY FATIGUED. BY THE NEXT NIGHT I WAS DIZZY. MONDAY MORNING OF 4/12 I GOT ... Read more
STARTED OFF WITH BEING REALLY FATIGUED. BY THE NEXT NIGHT I WAS DIZZY. MONDAY MORNING OF 4/12 I GOT UP TO GO TO WORK AT 7AM AND COULDN'T STAND. I HAD TO CRAWL TO THE BATHRROM TO VOMIT. COLD SWEATS FOR 24 HOURS. SICK FOR 3 DAYS WITH FATIGUE, NAUSEA, DIZZINESS AND DIARHEA. DRY MOUTH. UNAABLE TO BE STEADY ON MY FEET FOR 3 DAYS. BLURRED VISION. NUMBNESS IN ARMS, LEGS, HANDS AND FEET. UNABLE TO KEEP DOWN ANYTHING BUT GINGER ALE.
51 2021-05-02 pain in extremity The evening of my second vaccine injection, I started feeling pain in my inner thigh/groin area. The... Read more
The evening of my second vaccine injection, I started feeling pain in my inner thigh/groin area. The pain started getting worse in the second week after the injection. It hurt when I walked, sat, bent down to pick up something. The second week after I also developed pain in my left arm on the outside of arm, but had pain when I lifted my arm. The pain was worse at and through the night and in the morning, seemed to get a little better as I moved. The third week, the pain in my groin area had some relief while the pain in my arm spread to the other arm and both arms now have pain. It is increased when I try to lift over my head making it difficult to wash, brush hair and also to get dressed. Hurts more at night and in morning but once I get going seems to get better. Starting 5/1/21 the pain came back in my leg and now continues to the other leg. Both arms now are still hurting. The left side seems to be worse, but both sides hurt. I can't get comfortable when I sleep, so I am up tossing and turning. Also hard to get in and out of bed and also up and down on furniture.
51 2021-05-03 electric shock sensation, nerve pain 10 Days after receiving 1st vaccine I experienced an intense electrical/shock and/or stabbing sensat... Read more
10 Days after receiving 1st vaccine I experienced an intense electrical/shock and/or stabbing sensation located on my left foot near outer front ankle region. After the 1st episode an additional 2 more shock waves continued lasting a few seconds with a pain intensity level of 10. Three consecutive stabbing sensations lasted a total of about 30 seconds leaving me feeling very nauseous. Feels like nerve pain. Symptoms did not return until about a week later. Same intensity but this time continued daily with random shooting/stabbing sensations deep inside the ankle area. I've been dealing with this now for 2 solid weeks. I have had no prior injuries or complications in this region or anywhere around that part of my body. Approx. 8 1/2 hours after my 2nd vaccine I experienced several back to back shocking/stabbing sensations again in the same region warranting an emergency hospital visit. Xray of foot showed no trauma and doctor had no explanation for nerve pain. No nerve impingement characteristics identified after thorough evaluation of leg and foot. Doctor advised me to go home and take NSAIDS for a period of 2 weeks.
51 2021-05-03 limb paralysis left leg was paralyzed; muscle aches; vertigo; fell; This is a spontaneous report from a contactable... Read more
left leg was paralyzed; muscle aches; vertigo; fell; This is a spontaneous report from a contactable other health care professional(patient). This 51-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 19Jan2021 11:30 via an unknown route in left arm for Covid-19 immunization. Medical history included diabetic (diagnosed during hospitalization) and chronic pain. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 29Dec2020 11:30 AM in left arm for Covid-19 immunization. Patient had no other vaccine in four weeks, no other medications in two weeks. Patient had no covid prior vaccination. Patient had no known allergies. Patient started to have muscle aches on Wednesday morning (20Jan2020 08:00) the day after second COVID shot. Patient felt worse on Thursday. Patient went about daily activities to prepare for 24 hr shift on Friday. went to bed at 8:00pm because she had to get up at 04:00am for her shift. She tried to get out of bed and when she stood up and tried to take a step, left leg didn't move and patient fell forward on face. Patient thought she might of had vertigo. Patient struggled to get to the kitchen where she called of if work to her boss. Her left leg was weak. On Saturday the same thing happened. On Sunday she did the same thing. This time when she fell, left leg was paralyzed. She tried for 6 hours to get it to move. She called the ambulance and was taken to Hospital. She was admitted for 3 days. She had multiple tests and had been off work since then. Lab data included CT, MRI, and bloodwork. Treatment included IV fluids. Outcome of the events was resolving. Covid tested (Nasal Swab) post vaccination on 24Jan2021 was negative. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Ethics Committees and Investigators, as appropriate.
51 2021-05-03 pain in extremity Painful to lift arm. Pain at injection site. Bled when dose one shot was given. Over four months lat... Read more
Painful to lift arm. Pain at injection site. Bled when dose one shot was given. Over four months later and I am still having pain in my arm, not just at injection site. It hurts to rotate and lift and feels like the muscles are sore all of the time. Hurts to touch injection site but not continuously. Sometimes it feels like someone has punched me in the arm. Other times it feels like I have been stung by bees. This will even hurt into my shoulder and down to my elbow.
51 2021-05-03 tingling, muscle spasms Ischemic Stroke: I was sick with flu like symptoms the day after my test, including headache, fever... Read more
Ischemic Stroke: I was sick with flu like symptoms the day after my test, including headache, fever, chills, fatigue and body aches. I rested and treated with ibuprofen and tylenol. The second day after I was well enough to return to normal activities. However, after dinner, my left hand seized up and I had to shake out my hand to get it working again. This event lasted about 30 seconds. I had some small tingling in the evening after that. The next morining when I woke up my left arm was not functioning properly. It was weak, slow and I could not close my hand in a grip. My husband drove me to the ER where I received many tests over 3 days, resulting in the diagnosis of an ischemic stroke on the right side of my brain. Most of my arm function returned late afternoon the same day I was admitted.
51 2021-05-04 weakness 4/6, 6pm I started developing hives, a lot of hives, extremely itchy, they started on my forehead, t... Read more
4/6, 6pm I started developing hives, a lot of hives, extremely itchy, they started on my forehead, then neck then chest, then everywhere, some small some as large as a 50 cent piece. They itched beyond control. Then I started feeling week, lethargic, and my throat started to swell. I called a friend to take me to the ER, I was unconscious twice on the 5 mile trip to the hospital. Upon arrival, around 7:45pm, I had to be wheeled in I could not stand on my own, I had an intake blood pressure of 70/40. they immediately started IV lines, with prednisone, benadryl and saline (others too?) i was moved to a bed, and kept on the IV's. They took a lung x-ray, it was fine. Then a chest Xray, then EKG, was fine. My Lactate was 4.4, so i had to stay on the medicine and IV until it dropped to a lower level. They released me
51 2021-05-04 bell's palsy Bell's palsy; This is a spontaneous report from a contactable consumer (the patient). This 51-year-o... Read more
Bell's palsy; This is a spontaneous report from a contactable consumer (the patient). This 51-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm, upper arm, on 06Apr2021 14:00 (at the age of 51-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient denied being sick at the time of vaccination. The patient's medical history was not reported. No relevant family medical history was reported. There were no concomitant medications. On the night of 08Apr2021, the patient was having intense pain down her neck and behind her left ear, and it has been waking her up at night. On 09Apr2021, she went to Urgent Care and they misdiagnosed her with a possible oncoming ear infection. On Saturday morning (10Apr2021), she woke up and could not move the left side of her face so she went to the ER (emergency room) and they diagnosed her with Bell's Palsy. On 10Apr2021 at the ER, blood test for Lyme disease was negative. The ER gave the patient a steroid and antiviral pill and told her to follow up with her primary doctor in 8 days. The patient went to her physician's office on 19Apr2021 to follow-up with her Bell's Palsy. The patient stated that intense pain (down her neck and behind her left ear) was apparently a symptom of the Bell's Palsy. The only improvement with the Bell's Palsy was that she can sip out of straw a little easier but lips are still to the side. The clinical outcome of the event Bell's Palsy was resolving. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
51 2021-05-04 hot flush, feeling cold, night sweats Lethargy around 7pm. Night sweats and hot then cold sensation all night and ever since 2nd shot. I... Read more
Lethargy around 7pm. Night sweats and hot then cold sensation all night and ever since 2nd shot. I also did not get my period, which was due 3days after the 2nd dose. I?ve had hot flashes and cold/hot sensations every day and night since the shot. I had not, ever, experienced hot flashes prior to the 2nd shot. It feels as if the 2nd shot brought on instant menopause.
51 2021-05-04 migraine Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swa... Read more
Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swallow; Ears were itching, scratching her arms; Ears were itching, scratching her arms; really, really sick; Sore throat; throat and gland started swelling really big; throat and gland started swelling really big, glands were swollen; complaining about stomach; I noticed that my ear started swollen so bad; it is like an allergic reaction; Severe Flu-like symptoms, COVID-like symptoms; Migraine from back of her head, headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 13Apr2021 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Lyme disease. Concomitant medication was none. On 14Apr2021, the patient experienced severe flu-like and COVID-like symptoms which included body aches which was very strong, and feeling feverish, she was complaining about stomach, her throat and gland started swelling really big, her ear started to swell so bad, it is like an allergic reaction. On 15Apr2021, the patient experienced sore throat, and she got really, really sick. On 16Apr2021, the patient experienced glands were swollen, she could barely swallow, ears were itching, and she was scratching her arms. On 18Apr2021, the patient experienced I had rash, small tiny pimple a rash. On 19Apr2021, the patient experienced apnea episodes, felt like she couldn't breathe. On an unspecified date in Apr2021, the patient experienced, migraine from back of her head, headaches. On 16Apr2021, the patient went to urgent care, and she was tested for COVID, strep, influenza and they did a urine test, because she was also reporting stomach aches and pulmonary test. All the test results were negative. Cultures, to the previous tests were performed and everything was negative. The events required and emergency room visit and the emergency room doctor, didn't think it was an allergic reaction to the vaccine, because it took so long, to happen. The patient was treated for the events in the emergency room, with steroids, Benadryl and an intravenous infusion. The patient said that she was fine now. The outcome of the events was recovered on an unspecified date in Apr2021. Information on the lot/batch number has been requested.
51 2021-05-04 tingling severe back pain (ongoing 1 week), vertigo, extreme dizziness, pins and needles in hands and arms, f... Read more
severe back pain (ongoing 1 week), vertigo, extreme dizziness, pins and needles in hands and arms, fatigue
51 2021-05-05 feeling cold Starting at 3:30am I had a severe headache and fever of 102.9. All day I was taking Tylenol but it w... Read more
Starting at 3:30am I had a severe headache and fever of 102.9. All day I was taking Tylenol but it would not bring the fever back to normal. At 10 pm I was freezing, had severe body aches and a headache. At that time my fever was 104.2 I applied cool clothes and drank I?ve water and the fever went down to 103.4 after about an hour of that active treatment. Finally around 1:30 I began sweating and my fever was 101.6. The morning of the 5th I had no fever, but had aches and a headache. A fever developed in the afternoon of 100.8 so I took Tylenol and that helped. On the 6th I have no fever, but have a headache and fatigue.
51 2021-05-05 feeling hot, tenderness Left upper extremity "cellulitis" began within 24hrs of vaccination. At time of presentation to ER o... Read more
Left upper extremity "cellulitis" began within 24hrs of vaccination. At time of presentation to ER on 4/12, patient was complaining of warm, erythema, tenderness. Soft tissue US showed soft tissue edema without distinct fluid collection. She was treated with Keflex 500mg Q6H x7 days starting 4/12. Patient also had acute onset dyspnea on 4/12 associated with chest heaviness, which is what prompted her to go to the ER on 4/12. Troponins were neg x3 with no EKG changes, but she did have an AKI, which was treated with gentle IV fluids. LHC was offered during her hospitalization, but patient declined due to poor kidney function
51 2021-05-05 flushing Patient given 1st dose of Covid-19 Pfizer at 8:46am. Patient reported facial flushing, chest tightne... Read more
Patient given 1st dose of Covid-19 Pfizer at 8:46am. Patient reported facial flushing, chest tightness and SOB. PO Zyrtec given. Patients vitals stable. MD to bedside: lung sounds clear, heart rhythm normal. Pt Hx/ of anaphylaxis and asthma. See vital signs in flowsheet. Patient received IM benadryl and IM Epi x1, then reported continued hypersens systoms and reported back pain and chest pain, EMS called. Patient transferred to ED for continued monitoring.
51 2021-05-06 weakness tiredness; A little bit of chills; A sense of not feeling well/She just does not feel good/her body ... Read more
tiredness; A little bit of chills; A sense of not feeling well/She just does not feel good/her body not feeling okay; Her neck and head felt so heavy. Her neck and head felt so heavy that she could not hold it up; She felt like her body was so sick, she had no strength; she has pain in her back, neck and spinal cord; Body pain/body aches; Neck pain/neck felt so heavy; She felt like her body was so sick/Her body felt really really sick; Severe back pain/pain in her back; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) at right arm on 18Mar2021 09:00 AM at single dose for COVID-19 immunization (She believes in vaccines. She thinks its better to be vaccinated than to not be vaccinated). Medical history included COVID-19 from 01Feb2021 and three heart ablations. Concomitant medications were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) was None. Family Medical History Relevant to AE was None. She is calling about the Pfizer covid vaccine. She received her first dose of the covid vaccine on 18Mar2021. She got body aches (Mar2021) after. On 02Apr2021, she had to go to the emergency room. She had severe neck and body pain. She went to the emergency room because she could not take it anymore. Her body felt really really sick. Now she has pain in her back, neck and spinal cord (Mar2021). She has a weird feeling in her body. She just does not feel good. At the emergency room, they did blood tests on her. She did not have covid or the flu. Her hemoglobin came back normal, and so did all of the other things. She has this tiredness (Apr2021), pain in her back and a sense of not feeling well. She is calling to see what Pfizer suggests. She is asking if she can take anything, if so what can she take. She is asking how long will this last. She is asking if this is related to the vaccine. After first dose, Body aches began about five days after receiving the covid vaccine. She had body aches, a sense of not feeling well, and a little bit of chills. A little bit of chills began about five days after receiving the covid vaccine and resolved completely now. Clarifies that on 18Mar2021, she received the first dose of the covid vaccine. On that same day (18Mar2021), is whenever she had chills and a sense of her body not feeling okay. 48 hours after that, she had no more chills. Two or three days after, she started having back and neck pain. Her neck and head felt so heavy. Her neck and head felt so heavy that she could not hold it up. She was in pure desperation. She had to go to the emergency room. She never goes to the emergency room, unless she absolutely has too. She felt like her body was so sick, she had no strength. Then she received her second dose on 08Apr2021 (Lot number: ER8732). It has been 12 or 13 days since and her body aches have continued. She still feels like she is very sick. She just wants to lay down, but she can not because she has to work. She does not feel like herself. She feels like something is off in her body. Pain in her back, neck and spinal cord began two to three days after receiving the first dose of the covid vaccine. Body aches was reported as worsened. Pain in her back, neck and spinal cord was reported as worsened. No Investigation Assessment. She was not admitted to the hospital. Physician Office was No. outcome of Body pain, neck pian, Severe back pain, she has pain in her back, neck and spinal cord and She felt like her body was so sick was not recovered, outcome of chills is recovered in Mar2021, outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.
51 2021-05-06 burning sensation Client experience burning sensation to the arm. B/P: 130/90 Oxy: 100 Temp: 96.4 HR: 76
51 2021-05-06 difficulty speaking Patient complaint of sweating and headached starting 3 hours after vaccination. Next day, complaint ... Read more
Patient complaint of sweating and headached starting 3 hours after vaccination. Next day, complaint of seeing blurry, continued headache, nausea. Was off work several days, lost voice, still has hoarse voice
51 2021-05-06 feeling cold Pt C/O scratchy throat, facial and scalp itching and cold sensation extending down face neck shoulde... Read more
Pt C/O scratchy throat, facial and scalp itching and cold sensation extending down face neck shoulder to back area
51 2021-05-06 numbness Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient reported th... Read more
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient reported that hand was numb, that she couldn't feel her hand. She had an interpreter since she spoke anther language. Observed patient for 30 minutes and was still numb when she left. I attempted to verify her phone# that we had on profile which she said was correct and told her I would call her later to see how she was feeling. However, when I attempted to contact her I got an error message, so I'm unsure if she felt better or not. I did direct her to scan the CDC V-safe vaccination
51 2021-05-07 numbness Sweat, body ache, difficulty breathing, body numbness on hands and feet, dry throat, nauseas, ache i... Read more
Sweat, body ache, difficulty breathing, body numbness on hands and feet, dry throat, nauseas, ache in muscles.
51 2021-05-07 migraine Client was post vaccination and in the monitored observation area when she developed a migraine head... Read more
Client was post vaccination and in the monitored observation area when she developed a migraine headache. She reported her findings to the EMS team and was transferred to a cot in a low lighting, low stimulus area. She had eye covering placed to help with the photo-sensitivity. After approximately 20 minutes her symptoms improved and her sister accompanied her home. The client states that migraines are common for her and she declined further evaluation.
51 2021-05-07 muscle spasms Patient stated she started feeling nauseous right after the vaccine. Within the hour, she started h... Read more
Patient stated she started feeling nauseous right after the vaccine. Within the hour, she started having stabbing abdominal pain. This lasted about 2 days. Nausea lasted about 4 days. She also stated she started having muscle spasms in her calves that are still ongoing. Not known if the spasms are related to the vaccine, but they started around the same time.
51 2021-05-09 difficulty speaking, weakness, tremor about 4 minutes after vaccination: blurred vision, fast heart beat, shaking, high blood increased, t... Read more
about 4 minutes after vaccination: blurred vision, fast heart beat, shaking, high blood increased, throat was itchy, started coughing, voice went hoarse, headache, legs felt heavy. put in a room and monitored for about an hour, glucose test done. took Benadryl when I got home. felt like extremely fatigued/weak for 4 days.
51 2021-05-09 feeling cold It started on Friday with my head feeling like it was under a heat lamp while the rest of my body ha... Read more
It started on Friday with my head feeling like it was under a heat lamp while the rest of my body had goosebumps. I had the worst headache I can ever remember having. I was queasy & cold. When I stood up, I was dizzy. My hips, shoulders & neck were achy. I left work early and went home to go to bed. Saturday, I felt like I was recovering from a car accident. Achy neck, shoulders, back & hips. I was experiencing pain on my left side below my armpit. The pain on the left side continued through Sunday.
51 2021-05-09 muscle twitching Day 2 itching and swelling at the injection site; day 4 fever as high as 101.4; body aches; noticed ... Read more
Day 2 itching and swelling at the injection site; day 4 fever as high as 101.4; body aches; noticed painless, involuntary leg twitching after vaccine. I didn't think much of it until it disappeared about 2-weeks after the second dose.
51 2021-05-10 weakness, numbness Pt stated that got dizzy after getting the 2nd COVID-19 vaccine. Pt denies history of hypertension a... Read more
Pt stated that got dizzy after getting the 2nd COVID-19 vaccine. Pt denies history of hypertension and diabetes. Pt did not have breakfast and did not drink water prior to receiving vaccine. Pt was observed for 15 minutes and was given juice and water and reported doing well. Pt denies chest pain, shortness of breath and new onset of weakness and numbness. BP: 139/70, HR: 87. Stable, released from vaccination site.
51 2021-05-10 discomfort URI symptoms bodyache, fatigue, sinus pressure, nasal congestion, cough, sore throat. Can use OTC a... Read more
URI symptoms bodyache, fatigue, sinus pressure, nasal congestion, cough, sore throat. Can use OTC allergy medications like Claritin, Zyrtec and Allegra as needed. OTC Tylenol or ibuprofen for fever, discomfort. Recommended saltwater gargles, nasal saline sprays, humidifier and vapor rub at night.
51 2021-05-10 pain in extremity, tremor, muscle spasms, feeling cold extreme chills; body was shaking; teeth chattering; muscles were seizing; freezing/she had to get in... Read more
extreme chills; body was shaking; teeth chattering; muscles were seizing; freezing/she had to get in the bath she was so cold; soreness in in her arm; body aches; headache; tired; felt like she got hit by a truck last night, she felt terrible; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: ER8735, expiration date unknown) via an unspecified route of administration at left upper arm on 20Apr2021 at 11 am Mountain time at age of 51-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Patient previously received 1st dose of BNT162B2 on 30Mar2021 (Batch/lot number: ER8735) on left upper arm for COVID-19 Immunization. She didn't have any reactions with the first dose. There was no family medical history relevant to the events. Caller called about the Pfizer COVID vaccine second dose. She stated that last night on 20Apr2021 around 12 hours after receiving the 2nd dose she had extreme chills, her whole body was shaking, her teeth were chattering, muscles were seizing, and she was freezing. She stated that she had to get in the bath she was so cold. She stated getting the vaccine at 11 am mountain time. 12 hours after, later she was freezing, she had body aches, headaches, and she got scared, so she got up and read the pamphlet. She said that it was more than a little chilly, her whole body was shaking, teeth chattering, she stated it was bad. She did state that she felt okay today. Chills resolved this morning on 21Apr2021, probably about 1AM. She stated that she still had soreness in in her arm, was tired and she still had a headache. She stated that they were improved. She stated that she felt like she got hit by a truck last night, she felt terrible. She stated the body aches were still on going but they were improved. Patient didn't visit emergency room and physician office. Onset date of the events was 20Apr2021. Outcome of events extreme chills, "body was shaking", teeth chattering, "muscles were seizing", freezing was recovered on 21Apr2021, of events soreness in in her arm, body aches, headache, tired was recovering, of "felt like she got hit by a truck last night, she felt terrible" was unknown. No follow-up attempts are possible; information about lot/batch number requested.
51 2021-05-10 pain in extremity Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches... Read more
Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; bitter taste; This is a spontaneous report from a contactable consumer(patient). The 51-year-old female patient(not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Apr2021 14:30 (Batch/Lot number was not reported) as second dose, single for covid-19 immunization. Medical history included hashimoto. Concomitant medication included collagen, peptide powder, multi vitamins. She previously received sulfur based antibiotics. Historical vaccine included first dose of BNT162B2 on 03Apr2021 09:30 AM for COVID-19 immunization and experienced bitter taste in back of throat for half day on date of administration. After second dose, the patient experienced same bitter taste for 24 hours from time of administration. Pulse continued body aches especially in legs making her almost immobile, all on 26Apr2021 06:00 with outcome of recovering. Treatment included alternated taking ibuprofen(ADVIL) and paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID 19, Since the vaccination, the patient had not been tested for COVID 19. Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466738 Same patient/drug, similar AEs, different dose
51 2021-05-11 hot flush Received first Pfizer Covid Vaccine on 4/30/21. She states within 15 minutes of receiving the vacci... Read more
Received first Pfizer Covid Vaccine on 4/30/21. She states within 15 minutes of receiving the vaccine she experienced a weird sensation of her tongue, her heart was pounding, she felt flushed like her ears and head were on fire. She reported it to the nurse observing her. The nurse advised to wait another 15 minutes. She reports that BP was 170/110 P 110. Her BP continued to rise and developed tightness in chest and dizziness and RRT was called and she was transported to the ED. In ED she received Solumedrol, Benadryl, ASA 325mg and Pepcid. EKG and cardiac enzymes were normal, BP decreased to 130/90 and she was discharge at 9pm. Next day, she experienced the same adverse reactions and was taken to ED. Patient had COVID Infection in January 2021. Received first Pfizer Covid Vaccine on 4/30/21. PMHx of HTN receiving treatment. She states within 15 minutes of receiving the vaccine she experienced a weird sensation of her tongue, her heart was pounding, she felt flushed like her ears and head were on fire. She reported it to the nurse observing her. The nurse advised to wait another 15 minutes. She reports that BP was 170/110 P 110. She drank some water and performed deep breathing repeat BP 184/113 P 113. Drank more water repeat BP 189/130 developed tightness in chest and dizziness and RRT was called and she was transported to the ED. In ED received Solumedrol, Benadryl, ASA 325mg and Pepcid. EKG and cardiac enzymes were normal, BP decreased to 130/90 and she was discharged home at 9PM. The next day 5/1/21 awoke and felt fine however at 1PM experienced heart pounding, head on fire BP 150/104, 170/113, 189/130 took Benadryl, Pepcid and ASA; husband called 911 where she was taken to ED. Felt nauseated and was given Reglan. CT head was normal, CXR normal and was discharged to home. The next day 5/2/21 again was fine in the morning but again at about 1PM started experiencing the same symptoms and made herself some cucumber juice and went to see her PCP who scheduled her to see a cardiologist on 5/3/21. Cardiac w/u included EKG, Echo, Holter monitor and stress test. All were reported normal except has not received results of Holter monitor yet. The next day she developed 2 lesions on the side of her tongue which she self treated with glycerin and Vitamin C. Her BP has since normalized to 130/80-90 which is her baseline and she has not had any further symptoms.
51 2021-05-11 nerve injury Nerve damage; Dizziness; Lost her hearing in her right ear; This is a spontaneous report from a cont... Read more
Nerve damage; Dizziness; Lost her hearing in her right ear; This is a spontaneous report from a contactable consumer (patient, self-reported). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0162 and expiry date: Jul2021), via an unspecified route of administration, in Arm Left, on 08Apr2021, as a single dose for COVID-19 immunization. The patient's medical history included thyroid problem and seasonal allergies. The patient did not have any family medical history relevant to events. The patient did not receive any vaccine within 4 weeks prior to vaccination. Concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer COVID- 19 vaccine on 08Apr2021 and one day later on 10Apr2021 when she woke up in the morning, she lost hearing on her right ear. She mentioned her doctor told her she should call. She called her physician, and she did not have any accident or anything outside, she was healthy, she only had the vaccine. It bothers her. She described noise in her ear like a dog barking and her ear feels like a big pressure and every time she heard crying or talking or a loud sound, she could not hear. Her doctor never heard of this with the vaccine. She went to see a primary doctor and her HCP said this was due to allergies and pollen, because it was April and he said that he never heard of a hearing loss for COVID vaccine and prescribed Meclizine. She did not have allergy problems and anything wrong with her sinus or a runny nose, so she decided to go to a professional doctor, ear nose and throat. Then she went to see a ear nose and throat doctor on 15Apr2021 and 21Apr2021, and he said that he heard about a couple of cases with the vaccine and he tested her by performing a hearing test and it was true that the COVID-19 vaccine caused nerve damage. She was deaf in her right ear, her test came back horrible, she could not hear. The patient (withheld) said that this was because of the COVID virus in the vaccine, that destroyed nerves in the right ear and that was why she could not hear. She was currently taking Prednisone 10mg tablets, take 6 tablets for 3 days, and then 5 tablets for 3 days, and then 4 tablets and changes every 3 days. The patient was prescribed with meclizine 25mg tablets to take 3 times a day for dizziness. She did not have the dizziness when she took the pills. The patient also reported that she was healthy before and she usually takes the flu shot every year and this never had happened before. She was COVID-19 positive on 06Feb2021. She had COVID on 14Feb2021. The events did not require a visit to emergency room. The events were resulted in physician office visit. She would like to verify if this has happened to someone else before and if her hearing will return. The COVID-19 vaccine destroyed her health, and second vaccine was scheduled for 03May2021. The patient would like to know if she should get the second dose of the COVID-19 vaccine after presenting side effects from the first dose. The patient got response that she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. The patient was referred to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The patient's healthcare provider knows your health situation and has access to information that can better help inform this decision. Follow up attempts are possible further information is expected
51 2021-05-11 pain in extremity I experienced a sore arm a few hours after receiving the shot on 5/10/21. My arm stayed sore for abo... Read more
I experienced a sore arm a few hours after receiving the shot on 5/10/21. My arm stayed sore for about 24-30 hours. The following evening, I started feeling soreness and tenderness under my left arm pit.
51 2021-05-11 pain in extremity extreme soreness in the area of uterus; sore arm; has fibroid tumors and on Saturday night, she expe... Read more
extreme soreness in the area of uterus; sore arm; has fibroid tumors and on Saturday night, she experienced very severe cramping from them; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left deltoid on 23Apr2021 at 11:30 AM (at the age of 51 years old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included chronic pain, fibromyalgia, ongoing fibroid tumors, and penicillin allergy. Concomitant medications included pregabalin (LYRICA); diazepam; ibuprofen; morphine; and multivitamins. The patient received the shot on Friday on 23Apr2021. The patient experienced sore arm on Saturday (24Apr2021), which is expected. The patient also has pre-existing fibroid tumors, and on Saturday night (24Apr2021), she experienced very severe cramping from them. On Sunday (25Apr2021) and Monday morning now (26Apr2021), the patient is experiencing extreme soreness in the area of uterus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID post vaccination. The patient had not yet recovered from the events. Information on the lot/batch number has been requested.
51 2021-05-11 pain in extremity lump near injection site (vaccine was injected toward anterior/lateral not in normal muscle site) en... Read more
lump near injection site (vaccine was injected toward anterior/lateral not in normal muscle site) entire right arm in pain right thigh pain, right ankle pain and swelling lower back pain loss of smell, taste, nausea, diarrhea right sided joint pain extreme fatique
51 2021-05-12 pain in extremity Sore arm about 7 hours post injection. Soreness migrated to upper neck and around to shoulder area i... Read more
Sore arm about 7 hours post injection. Soreness migrated to upper neck and around to shoulder area in back. Lasted for two (2) days. Took Tylenol and that helped relieve pain.
51 2021-05-12 tingling patient felt lightheaded, nauseous, head ache developed, legs were tingling
51 2021-05-12 tremor Syncope and tremors
51 2021-05-13 cold sweat Dizziness & clammy. No LOC; AOx4; dizziness resolved, skin warm & dry after 15 min (BP 131/67; HR 80... Read more
Dizziness & clammy. No LOC; AOx4; dizziness resolved, skin warm & dry after 15 min (BP 131/67; HR 80; RR 15). Pt stable & released from vaccination site
51 2021-05-13 numbness, tingling 3 hours after injection the left side of my face went numb and tingly
51 2021-05-13 muscle twitching Muscle twitches; The initial case was missing the following minimum criteria: no Identifiable report... Read more
Muscle twitches; The initial case was missing the following minimum criteria: no Identifiable reporter. Upon receipt of follow-up information on 19Apr2021 this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer sponsored program Corporate (Pfizer) Social Media Platforms reported from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8734), via an unspecified route of administration in left arm on 02Apr2021 at 11:00 (at the age of 51-years-old) at single dose for COVID-19 immunization. Medical history included ongoing morphea for about five years. There were no family history and concomitant medications. In Apr2021 (either the 02Apr2021 or 03Apr 2021), within 24 hours of getting the Pfizer COVID-19 vaccine, the patient had been experiencing muscle twitches for about 16 or 17 days (at the time of report). The patient asked whether she should get the second dose. The patient did not undergo lab tests and procedures. No treatment was received for the event. The outcome of the event was reported as worsened (not recovered). No follow-up attempts are possible; No further information is expected.
51 2021-05-13 pain in extremity Intense pain in my left leg without being able to move it. Myalgia.
51 2021-05-13 tingling About 30 minutes after getting the first shot of Pfizer vaccines, the left side of my body started t... Read more
About 30 minutes after getting the first shot of Pfizer vaccines, the left side of my body started to feel like getting swollen. Left half of my face started feeling swollen and tingling - like when your dental anesthesia was wearing off, and my left arm feeling swollen. I checked my left hand and my face on the mirror to see if they were really swollen, but they looked normal. I think it was more of the neurological effect. I can't remember if my left leg was also impacted. I think about 30 minutes or so, it started get better so I didn't go to see a doctor. About an hour after the shot, I think it was pretty much gone. Now, I may be too self conscious, but I feel like something wrong /weird with the left side of my body/face, but that may be my anxiety tricking me.
51 2021-05-13 tremor, migraine, cold sweat, pain in extremity Major migraine, hot/cold sweat at the same time, body aches, arm sore, fever, uncontrollable shakes,... Read more
Major migraine, hot/cold sweat at the same time, body aches, arm sore, fever, uncontrollable shakes, skin all over body felt like it was on fire
51 2021-05-14 electric shock sensation Perhaps this is a very mild case of thrombocytopenia?; develop bruises and petechiae, which "travel"... Read more
Perhaps this is a very mild case of thrombocytopenia?; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; severe muscle and joint pain; severe muscle and joint pain; low electrical shock in limbs; hives all over my body which would welt up like measles if I scratched them; This is a spontaneous report from a contactable Consumer (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:45 (at 51 years old, not pregnant) (Batch/Lot Number: EP7533) as 2nd dose, single for covid-19 immunisation. Medical history included cholesteatoma from an unknown date (Cholesteatoma as a teen--resolved with modified canal-wall down tympanomastoidectomy. No problems since 1989-1990), Allergy to cephalosporins, Sulfa drugs, strawberries, all from an unknown date. The patient had no concomitant medications. The patient had her first dose of bnt162b2 (Lot numberEN6204) vaccine on Mar2021 12:45 at 51 years old on left arm for COVID-19 Immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second dose, after about 12 hours (reported also as 09Apr2021 22:00), as expected, patient had moderate to severe muscle and joint pain and a sensation of low electrical shock in limbs. No other symptoms and this resolved in 24 hrs. Eight days after dose 2 (reported also as 09Apr2021 22:00), patient developed hives all over the body which would welt up like measles if patient scratched them. Patient tolerated them for 19 days before patient finally sought help from a doctor, who prescribed a short 20mg/2X/day course of prednisone and hives are improving significantly. However, wherever she scratches these hives on her legs,especially right, she developed bruises and petechiae, which "travel" up and down her thigh corresponding to where she scratches. She was in good health, active, and don't bruise easily. Bruising has not resolved over about 23 days, but has not gotten worse. Patient has no other symptoms. Perhaps this is a very mild case of thrombocytopenia. The adverse events resulted in visit to Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was Prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. All the events start date was reported as 09Apr2021 22:00 (for clarification). The outcome of the vaccines was recovering. The patient underwent lab tests and procedures which included Weekly spit test--work: negative on 11Mar2021; negative on 18Mar2021; negative on 25Mar2021; negative on 08Apr2021; negative on 19Apr2021; pending on 28Apr2021. Device used Date : 02May2021 Information about Lot/batch number was available. Further information was expected.
51 2021-05-14 grand mal seizure This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EWO151) via an unspecified route in the left arm on 14Apr2021 at 11:30 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination included insulin and metformin. On 15Apr2021 at 06:00 (reported as18 hours later), the patient had a "gran map seizure" and had to be taken to the hospital via ambulance. The event resulted in visit to emergency room/department or urgent care. The patient was not treated for "gran map seizure". The clinical outcome of "gran map seizure" was unknown. Since the vaccination, the patient has not been tested for COVID-19.
51 2021-05-15 tingling, burning sensation, pain in extremity Intermittent tingling in fingers, then erythematous macular skin lesions on toes, followed by severe... Read more
Intermittent tingling in fingers, then erythematous macular skin lesions on toes, followed by severe fatigue, tingling and pain in feet/lower legs and hands. Toes bluish/purple with intermittent erythema and burning pain of feet. Periungual erythema with dilation of capillary loops (confirmed by dermatologist with expertise in connective tissue disease). Symptoms currently persist.
51 2021-05-16 feeling cold, pain in extremity About 23 hours after shot, arm was very sore not only at injection site but in armpit area. Later i... Read more
About 23 hours after shot, arm was very sore not only at injection site but in armpit area. Later in the day, there was a knot in armpit area size of a golf ball. Started feeling achy all over, had 3 blankets on and was still cold, vomiting for about 3 hours and extreme fatigue. Late same evening stopped vomiting and chills stopped, but still very tired and achy all over. The next day still had extreme fatigue all day, no appetite and armpit still hurting. Monday morning just felt tired and armpit just mildly sore with the knot that was there gone. As day goes on feeling better.
51 2021-05-16 feeling hot Heating or hot feeling that comes and goes in right calf.
51 2021-05-16 flushing Within 5 minutes of injection, client became flushed and diaphoretic. She felt extremely nauseated ... Read more
Within 5 minutes of injection, client became flushed and diaphoretic. She felt extremely nauseated and vomited x1. Client had not eaten breakfast before injection. Client monitored for over 1 hour in dark quiet room where client was able to recline and relax. Vital signs were stable. No difficulty breathing or swallowing.
51 2021-05-16 numbness, tingling took Benadryl 1/2 Tab prior to Vaccine due to having many food and seasonal allergies. appx 22 minu... Read more
took Benadryl 1/2 Tab prior to Vaccine due to having many food and seasonal allergies. appx 22 minutes after Vaccine in Right arm I had a funny and bad taste in my mouth. Shorthly after that My tongue and roof of my mouth felt smooth, followed by numbness in my upper lip and then lower lip. I went to the Nurse at check out and had asked how my face was I often get red and flush and blotchy when having an adverse reaction. she said I did not look well and wanted me to keep my mask off and hook me up to be monitered and take my blood pressure, I then also took the othr half tab of Benadryl that I had in my pocket. I then got a really bad metal taste in my mouth and drank a bottle of water. Then I thought I was doing better then my Right Pinky finger felt numb or (Asleep) followed shortly by my right ring finger and then whole right hand. They then took my BP again and was high so they had suggested I go to the ER in the Hospital to be monitored. I agreed the numbing on my arm and high BP was concerning since my BP typically is very Normal. after about 2 to 3 hours I started to feel much better so asked to be released once the tingling/numbness was gone and all my blood work came in great.
51 2021-05-16 numbness "Dizziness, Nausea, elevated BP. Pt brought to triage area by vaccinator TRN after receiving first ... Read more
"Dizziness, Nausea, elevated BP. Pt brought to triage area by vaccinator TRN after receiving first dose PFIZER. Pt present with spouse. Pt reported feeling dizziness. Placed on recliner chair. Pt denied experiencing any other abnormal sx - no SOB, chest pain, pain. Hx of fibromyalgia. NP on-site and lead made aware. V/S: 2:40PM - BP: 178/113 HR: 123, O2: 97% 2:45PM - BP: 144/96, HR: 120, O2: 94% 3:00PM - BP: 128/84, HR: 100, O2: 96% Monitored pt for 30 min. Offered fluids. Pt brought via W/C to observation area. NP reevaluated and encouraged pt to seek ED services for further eval d./t pt c/o numbness to Lt arm length. Pt and spouse decide to seek ED at another site: Kaiser. Encouraged to call 911 for any sudden change or worsening of sx. Pt and spouse left site."
51 2021-05-16 pain in extremity Arm extremely sore for 2-3 days after injection. Continual soreness and reduced range of motion stil... Read more
Arm extremely sore for 2-3 days after injection. Continual soreness and reduced range of motion still present five weeks after injection. Upper left arm at injection site.
51 2021-05-16 tremor, weakness, pain in extremity Heart pounding and racing, body shakes, dry mouth, weakness. They told me not to worry and I should... Read more
Heart pounding and racing, body shakes, dry mouth, weakness. They told me not to worry and I should just rest. No need to go to the clinic. My left arm is also very sore, all the way up to my neck and down the back of my shoulder.
51 2021-05-16 tremor, discomfort A day and a half after getting the vaccine, I experienced heart pounding, body shakes, heart racing,... Read more
A day and a half after getting the vaccine, I experienced heart pounding, body shakes, heart racing, pressure over entire body. Called 911 and went to the emergency room.
51 2021-05-17 weakness flu like symptoms; headache; Shaky; pass out; feel faint; felt a bit achy; sweat; very weak; This is... Read more
flu like symptoms; headache; Shaky; pass out; feel faint; felt a bit achy; sweat; very weak; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 29Apr2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. at the age of 51 years old. The patient medical history was not reported. The patient was not pregnant. Concomitant medication(s) included loratadine, pseudoephedrine (CLARIDIN-D) (medications the patient received within 2 weeks of vaccination). The patient previously took bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:30 AM (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced pass out, feel faint, felt a bit achy, sweat, very weak,shaky all on 30Apr2021 07:30, flu like symptoms and headache on an unspecified date. Reported as: I received my shot on Thursday afternoon. Friday morning, I woke up and felt a bit achy, but otherwise OK. I drove my daughter to school and in the car on the way, I began to feel faint. I pulled over, broke into a sweat, and proceeded to pass out in the drivers seat. My daughter called my friend who picked us up. I was shaky, and very weak. I went home, had fluids and slept for the remainder of the day with flu like symptoms and a headache. By Sunday, I was back to normal. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered. Information about lot/batch number cannot be obtained. No further information expected.
51 2021-05-17 breast pain My period started after being on menopause for a year. It started in April 2021. Both of my breast ... Read more
My period started after being on menopause for a year. It started in April 2021. Both of my breast have been in pain for past month. This week, I got my period again, except much heavier than last month. I had an MRI done last week and the lining of the uterus thickening was seen. In the past, my period was only 3 days but this month, it's been 5 days and I'm still bleeding.
51 2021-05-17 numbness Numb left ear and parts of left side of face; Heart Pressure; Irregular heart palpitations; very sca... Read more
Numb left ear and parts of left side of face; Heart Pressure; Irregular heart palpitations; very scary; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received first dose of BNT162B2 (Lot Number: ER8731) via an unspecified route of administration, administered in left arm on 07Apr2021 at 14:00 at age of 51-year-old as single dose, and received second dose of BNT162B2 (Lot Number: EWO167) via an unspecified route of administration, administered in left arm on 28Apr2021 at 14:00 at age of 51-year-old as single dose for covid-19 immunisation. Medical history was not reported. Facility where the most recent COVID-19 vaccine was administered reported as Public Health Clinic facility. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 28Apr2021 at 16: 00, patient experienced heart pressure, irregular heart palpitations - almost went to emergency room a few times. Patient was very scary, had numb left ear and parts of left side of face. No Hospitalization Prolonged. No treatments were received for events heart pressure, very scary and numb left ear and parts of left side of face. The outcome of events was recovered with sequelae. Information on Lot/Batch number was available. Additional information has been requested.
51 2021-05-18 numbness, tingling tingling and numbness in hands, arms, and feet.
51 2021-05-18 pain in extremity After first dose the next evening muscle and joint pain in left wrist, left lower arm and left hand.... Read more
After first dose the next evening muscle and joint pain in left wrist, left lower arm and left hand. Swelling in left wrist and hand difficult to close hand. Stinging pain in left wrist, left lower arm and left wrist. Stinging pain still comes and goes in left lower arm, wrist and hand. Pain and swelling has improved. Second dose in right arm was normal with no adverse reactions.
51 2021-05-18 tingling Feeling a little dizzy here and there, so I am worried/ intermittent mild dizziness; Swelling in sof... Read more
Feeling a little dizzy here and there, so I am worried/ intermittent mild dizziness; Swelling in soft palate and uvula/Soft palate tingling then swelling including uvula (area tender from swelling); Having flare up with my rosacea/Redness on rosacea area; Soft palate tingling then swelling including uvula (area tender from swelling); Soft palate tingling then swelling including uvula (area tender from swelling); Soft palate tingling then swelling including uvula (area tender from swelling); Mild swelling around nose, eyes and lips (areas feel tight sort of burn); mild swelling around nose, eyes and lips (areas feel tight sort of burn); mild swelling around nose, eyes and lips (areas feel tight sort of burn); mild swelling around nose, eyes and lips (areas feel tight sort of burn); Swelling in my face and throat; Tingling; Swelling in my face and throat; Redness of rosacea really pop-up red and then my lips were just slight little swollen around my nose and around my eyes; Redness of rosacea really pop-up red and then my lips were just slight little swollen around my nose and around my eyes; This is a spontaneous report from a contactable consumer (Patient). A 51-years-old female patient non-pregnant received 1st dose of BNT162B2, (Pfizer covid-19 vaccine Formulation: Solution for injection, Lot number: EN6207) via an unspecified route of administration, administered in arm left on 13Mar2021 09:45 as 1st dose, single for covid-19 immunisation. Medical history included allergy, insulin resistance, food intolerance, yeast, rice, spaghetti squash, hybrid pumpkin, yogurt, asthma, Thyroid and Hypermobility in joints. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) for Allergy; levothyroxine for thyroid; vilazodone hydrochloride (VIIBRYD); phentermine hydrochloride, topiramate (QSYMIA) and allergy Shot. No other vaccine was received in four weeks. Known allergies are Amoxcillin, Bactrim DS, yeast, rice, spaghetti squash, hybrid pumpkin, Betadine alcoolico, Metrogel, yogurt. Other medical history includes Allergies, asthma in remission, adverse reactions to Welbutrin, Contrave, Oxcarzepazine, Victoza. Patient had surgeries. Patient had blood drawn to check calcium level but don't know if that was within the last 2 weeks. On 13Mar2021 patient stated that I had my first Covid vaccination yesterday (13Mar2021) and I did report "Online" (further not clarified, hence captured as initial report) because I did have some swelling in my face and throat and there was sometimes that I was feeling a little dizzy here and there, so what I am worried about is, if I am going to not have the next vaccination because I am scared of the disease too. That's why I called. When paraphrased the concern, consumer stated, Yes and now the swelling that I had was on my soft palate and my uvula. It started tingling and then I did have some swelling there and on my face, I have rosacea and, so was having the flare up with my rosacea anyway, and that made all the areas that I had the redness of rosacea really pop-up red and then my lips were just slightly swollen and it was a little swollen around my nose and around my eyes and the dizziness it was just here and there, it was not anything big but this is a kind of reaction that I have, the thing the soft palate of my throat I have had that before when I had eaten eat something yeast and something like that, so I do not know is the shot may be have yeast so but I have not had that kind of slight swelling there on my face before, that's what I called. When probed for other Medical condition, consumer stated, I actually have allergies, they were pretty bizarre (not clarified) and Allergist calls me his special patient and I have food intolerances, so that's, the things right they are a lot of them. The thing that has calls me the most trouble is yeast. It does not matter if it is baker's yeast or brewer's yeast or yeast extract and I have unusual one like spaghetti squash and hybrid pumpkin, the spaghetti squash was the pumpkin and having that spaghetti squash in the hybrid pumpkin mainly react to it. In response to other medical condition, consumer stated, "There are other medication, I do have some other health conditions, I have Hypermobility in my joints, and I have a lot of "weird" (not clarified) things that I had like surgeries for different thing too but the main, and I am considered insulin resistance and I have had reactive low blood sugar at a time. Shot at 09:45 on 13Mar2021, experienced Soft palate tingling then swelling including uvula (area tender from swelling), mild swelling around nose, eyes and lips (areas feel tight sort of burn), intermittent mild dizziness. Redness on rosacea area. Benadryl -1 at 10:30, 1 at 11am, 2 at 2:41pm experienced headache (pain, pressure) at 01:45, Advil -1 at 07:45 experienced face flushed/hot feeling. Benadryl was self-administered as treatment. No covid prior vaccination and the patient was not tested for covid tested post vaccination. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
51 2021-05-19 burning sensation, tingling swollen lymph node in my left armpit the size of a grapefruit; chills; nausea; headache; fever; swea... Read more
swollen lymph node in my left armpit the size of a grapefruit; chills; nausea; headache; fever; sweating; burning/tingling in my entire arm,; fatigue; aches; burning/tingling in my entire arm,; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 (Batch/Lot Number: EW 0175) (at the age of 51 years old) as 1st dose, single for COVID-19 immunisation. Medical history included migraines from an unknown date and unknown if ongoing, and COVID in Mar2020 (including long haul effects such as loss of smell for 6 months and losing handfuls of hair). The patient's concomitant medications were not reported. It was reported that patient had COVID in Mar2020. She tested positive for antibodies in Apr2020. Upon receiving the first dose this past week, she ended up reacting just like she had COVID all over again. Within 4 hours she had chills, nausea, headache, fever, sweating, burning/tingling in my entire arm, aches, fatigue, etc, then she developed a swollen lymph node in the left armpit the size of a grapefruit. Acute symptoms persisted for 5 days (she was in bed the whole time) and she still have the swollen lymph node. She expected some symptoms for the second shot, but not the first. She was now very concerned about getting the second dose, especially since she read studies showing she could have as much protection after one shot since she had COVID as people who didn't have COVID. Additionally, she was a smaller woman and feel like maybe the dosage was too high. She was very healthy with no comorbidities except she had COVID previously (including long haul effects such as loss of smell for 6 months and losing handfuls of hair). The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient diagnosed with COVID-19. The patient has been tested for COVID-19 since the vaccination. PCR (Nasal swab) was done on 03May2021 with negative result. The outcome of events was recovering.
51 2021-05-19 flushing REDNESS AND FLUSHING OF FACE; EXTREMELY HIGH SPIKES IN BP
51 2021-05-19 pain in extremity Left shoulder pain, bilateral lower leg achiness and pain Pain has waxed and waned since the date o... Read more
Left shoulder pain, bilateral lower leg achiness and pain Pain has waxed and waned since the date of onset.
51 2021-05-19 pain in extremity extremely heavy flow period that lasted 20 days; mild cramping usually occurring in the late morning... Read more
extremely heavy flow period that lasted 20 days; mild cramping usually occurring in the late morning nearly every day resulting in heavier discharge; slightly tired; sore arm; Achy joints; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9264; Expiration date was not reported), via an unspecified route of administration, administered in the left arm on 07Feb2021 16:00 (at the age of 51-years-old) as second dose, single for COVID-19 immunisation at a workplace clinic. Medical history included perimenopause in which the patient was having longer durations between periods but relatively normal (for her) in length of four to five days, environmental allergies and a heavy menstrual bleeding in which was described as one period about 14 months prior that was longer and heavier than she typically experienced however it only lasted for just over a week with slightly heavier discharge with some clumps; all of which from an unknown date and unknown if ongoing. Concomitant medication included paracetamol (TYLENOL) and ibuprofen; both taken for an unspecified indication, start and stop dates were not reported. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and experienced drug allergy. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3249) administered in the left arm on 17Jan2021 16:30 for COVID-19 immunisation. Patient was not pregnant. No other vaccine was given in four weeks. Patient was not COVID positive prior vaccination and was not tested for COVID post vaccination. On 09Feb2021, the patient experienced extremely heavy flow period that lasted 20 days. It was reported that the patient started her period approximately 48 hours before receiving the second dose of the vaccine and her flow was pretty typical until a couple days after her shot at which time she developed a much heavier flow with large, thick, dark clumps of bloody discharge. The patient also experienced mild cramping usually occurring in the late morning nearly every day resulting in heavier discharge, slightly tired, sore arm and achy joints on 09Feb2021. It was also reported that since the patient has history of heavy menstrual bleeding, she was not initially alarmed by the heavier flow. The patient began to have some concern as the period wore on but felt normal in every other way. No treatment was given for the events. The outcome of the events was recovered.
51 2021-05-20 bell's palsy BELLS PALSY
51 2021-05-20 tenderness, numbness CLIENT VACCINATED ON TUESDAY. ON WEDNESDAY CLIENT NOTICED SOME SLIGHT NUMBNESS IN THE LEFT ARM, ARMP... Read more
CLIENT VACCINATED ON TUESDAY. ON WEDNESDAY CLIENT NOTICED SOME SLIGHT NUMBNESS IN THE LEFT ARM, ARMPIT AREA, SIDE OF THE BREAST. ON THURSDAY MORNING CLIENT REPORTS "VERY NUMB", SLIGHTLY PAINFUL AND TENDER. NO CHANGE IN PHYSICAL APPEARANCE BUT DOES FEELS SWOLLEN BY THE TOUCH. LEFT HAND WAS SWOLLEN IN JOINTS, AND WAS TENDER. CLIENTS REPORTS SOME ARTHRITIS. IMPROVEMENT OF ARM THE NEXT DAY. CLIENT WILL SEEK MEDICAL ADVICE IF SYMPTOMS WORSEN OR DO NOT IMPROVE. RECOMMENDED TO SPEAK WITH ONCOLOGIST TO SEE IF OTHER CLIENTS WITH BREAST CANCER AND HX OF DOUBLE MASTECTOMY HAVE NOTICED ANY REPORTS IN OTHER PATIENTS.
51 2021-05-21 weakness, pain in extremity, feeling hot nearly passed out; the shoulder where she got her injection started hurting really bad; getting hot;... Read more
nearly passed out; the shoulder where she got her injection started hurting really bad; getting hot; sweating; thirsty; Her blood pressure dropped; couldn't breathe; arm hurting really bad; got very weak; turned gray, like an elephant; felt floaty; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at left shoulder (Arm Left) on 19Apr2021 10:00 AM at age of 51 years old (Batch/Lot number was not reported) as 1ST, SINGLE for covid-19 immunisation. The patient's medical history was reported as just told her blood pressure dropped on an unknown date, hooked patient up to a bunch of wires and stomach, monitoring her on a machine. The last couple of time patient had blood drawn, the one last time, she went into shock and passed out. This wasn't quite the same thing with this time. This was maybe 2 years before unspecified date. One time it was pretty bad and patient fell down, get the doctor and hook patient up to all that stuff. Didn't' quite feel the same way as this time. She didn't get hot and sweaty. Patient was not taking any pills. The concomitant medications were not reported. After first dose of the Pfizer covid vaccine. After the injection on 19Apr2021, patient sat for 15 minutes (wait for 15 minutes) and the shoulder where she got her injection started hurting really bad. Arm hurting really bad, walked across the hall and sat in the chair, maybe 2 minutes later. Then started tearing her mask off because she couldn't breathe. Patient started getting hot, sweaty and thirsty. Patient was sweating, started getting hot and thristy and then got really sweaty and super hot. Got really thirsty and was given water. She was trying to grab a bottle of water and she didn't have the strength. She got very weak, turned gray, like an elephant and her blood pressure dropped, and nearly passed out. It lasted maybe 10 or 15 minutes. They called the ambulance. By the time they got there, she was feeling more back within herself and It was pretty much done and was totally better, maybe 90 percent. She just wanted to go home and did not go in the ambulance. She felt floaty but did not pass out. With the first one, she had a reaction and is wondering if she should even take the second one. Therapeutic measures were taken as a result of thirsty included water. Treatment for other event was reported as none, and she was not taking any medication. The event outcome of recovered on 19Apr2021. Information about lot and batch number was requested.
51 2021-05-21 numbness This is a spontaneous report received from a contactable consumer (patient). This 51-year-old female... Read more
This is a spontaneous report received from a contactable consumer (patient). This 51-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 15:45 as single dose for COVID-19 immunization. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications the patient received within 2 weeks of vaccination. On 09Apr2021 at 07:30 PM, patient experienced left leg went numb (also reported as 3 hrs after shot), next day felt slightly better, by day 4 ended up in ER (emergency room) and was admitted for legs not working correctly and weakness in left leg. The events resulted in hospitalization for three days. Patient underwent COVID-19 (Nasal Swab) tested post vaccination on 11Apr2021, COVID-19 test result: Negative. Patient received treatment included medication, physical therapy for the adverse events. Outcome of the events was recovering. Follow-up attempts are needed; information about lot/batch number is requested.
51 2021-05-21 pain in extremity second period two weeks after the second dose; headache; sore arm; slight temperature; tiredness; Th... Read more
second period two weeks after the second dose; headache; sore arm; slight temperature; tiredness; This is a spontaneous report from a non-contactable consumer. A 51-year-old female patient received second dose of BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 03Apr2021 03:45 (Batch/Lot Number: ER8734) as 2ND DOSE SINGLE for covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, The patient has not been tested for COVID-19 since the vaccination. The patient experienced second period two weeks after the second dose, headache, sore arm, slight temperature and tiredness all on Apr2021. No treatment was received for all the events. The outcome of second period two weeks after the second dose was unknown. Outcome of all the other events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
51 2021-05-21 tingling Patient experienced back of throat tightening, lip tingling and Left side facial tingling. Symptoms ... Read more
Patient experienced back of throat tightening, lip tingling and Left side facial tingling. Symptoms resolved 35-minutes after taking Benadryl 50 mg po. VS were stable throughout and no shortness or breath.
51 2021-05-22 migraine, numbness Numbness on entire left side, migraine headache for 2 days, and heavy break thru vaginal bleeding
51 2021-05-22 migraine Non stop severe migraines
51 2021-05-22 numbness and pain in extremities peripheral neuropathy
51 2021-05-22 tingling, numbness Within 10 minutes of receiving the vaccination in my right arm I started having painful pins and nee... Read more
Within 10 minutes of receiving the vaccination in my right arm I started having painful pins and needle sensations in both hands and wrists. It lasted for about 15 minutes. Then, my arms felt slightly numb to the touch
51 2021-05-23 weakness Severe knee pain -- Arthritis flareup? I did not have this before the vaccine. It was debilitating e... Read more
Severe knee pain -- Arthritis flareup? I did not have this before the vaccine. It was debilitating enough I was using a cane and needed a wheel chair at times. Meloxicam has helped alleviate some symptoms, but I am still in pain
51 2021-05-23 hot flush, burning sensation, feeling hot When I received the first dose 4/7/21, I had a burning sensation go up my left arm to my face. My f... Read more
When I received the first dose 4/7/21, I had a burning sensation go up my left arm to my face. My face felt hot and then my chest. I felt scared like I could be having something wrong but I continued on. I then got very tired. The next day I felt achy knees. Two days later I started having buzzing in my ears but didn't realize it could be a side effect. I went to a Urgent Care and was treated for a possible ear infection and given antibiotics. That did not help or cure my condition. The buzzing/ringing is on the same side/left as my injection. On 5/5/21, I went for my second injection and asked if the buzzing/ringing or being on antibiotics was a problem, they said no. The buzzing/ringing increased. I went to my regular Primary Care doctor who didn't see anything wrong. She referred me to an ENT. The ENT ran a hearing test. The hearing test seemed to come back ok but I still have the Tinnitus. The Tinnitus is worse at night and in the morning when everything is very quiet. Some days are worse than others and I have seen no improvement. I also am experiencing hot flashes. They also happened after the first shot and increased after the second. The Tinnitus is very bad at time and I want it to go away. It is like buzzing in my left ear that is always there but sometimes I can tune it out. I think it is important to report this as I have not had anyone tell me it is a possible side effect. If it is than this needs to really be investigated and studied and communicated with people. It is very disturbing as I have never had Tinnitus before. I hope and pray it goes away and there are no other side effects.
51 2021-05-23 muscle spasms, pain in extremity 13 hours post (second) vaccination, I developed the usual/listed symptoms: sore arm, extreme chills... Read more
13 hours post (second) vaccination, I developed the usual/listed symptoms: sore arm, extreme chills, overall body aches, fatigue and a bad headache. All of those lasted about 3 solid days. I also developed muscle spasms, similar to the feeling of a "charlie horse" during that time in my feet and left arm and hand. The next day, they developed in my groin (both sides). It feels like the muscles in my feet are curling inward when they occur. The ones in my arm, hand groin usually subside after a 3-5 minutes. These muscle spasms have continued daily and the ones in my feet are especially bad at night when I am lying down.
51 2021-05-24 burning sensation, tingling Systemic: swelling in both feet, burning sensation in both feet-Medium, Systemic: Tingling (specify:... Read more
Systemic: swelling in both feet, burning sensation in both feet-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient reported that 48 hours following first dose she experienced swelling in both feet and a burning sensation in both feet. These symptoms have persisted for greater than 24 hours and have not subsided when reported at 4:42 pm 5/24/21
51 2021-05-24 feeling hot, tingling, flushing Patient reported hot, tingly, and itchy face immediately after vaccine. Face was flushed and felt li... Read more
Patient reported hot, tingly, and itchy face immediately after vaccine. Face was flushed and felt like heart rate more rapid than normal and some chest tightness. Patient denied any itching or tingling in throat or mouth and also thought it might just be her anxiety. After a few minutes patient reported symptoms not worse or spreading but about the same. Had patient take off mask to breathe better, have some juice and gave 50mg oral liquid benadryl. Patient was feeling better about 3 minutes later and stayed for additional 15 minutes for observation and then left on her own with her son. Son would drive home.
51 2021-05-24 numbness Tongue numbness loss of tastes. Chin, cheek and lip lower. Loss of taste right half of all.
51 2021-05-24 pain in extremity Fever 102 Fahrenheit; Severe leg and foot pain; Short of breath; Headache; Chills; This is a spontan... Read more
Fever 102 Fahrenheit; Severe leg and foot pain; Short of breath; Headache; Chills; This is a spontaneous report from a contactable other HCP (Patient). This 51-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an Intramuscular route, administered in Arm Left, on 20Jan2021 at 09:00 AM (at the age of 51-year-old) as a single dose for COVID-19 Immunization, at hospital. Patient's medical history was not reported. Patient had no Known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC), lamotrigine (LAMICTAL) and ergocalciferol (VITAMIN D); which were administered within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an Intramuscular route, administered in Arm Left, on 31Dec2020 at 09:00 AM (at the age of 50-years-old), as a single dose for COVID-19 Immunization. Patient did not receive other vaccines in four weeks of vaccination. Patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID since post vaccination. On 20Jan2021, at 09:00 PM, the patient experienced Fever 102 Fahrenheit, severe leg and foot pain, short of breath, headache and chills. No treatment was given for the events. Outcome of the events was recovered on an unknown date in Jan2021. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
51 2021-05-24 pain in extremity After the 2nd shot, second day after; I had left arm pain that woke me up in the middle of the night... Read more
After the 2nd shot, second day after; I had left arm pain that woke me up in the middle of the night. I also, suffered a terrible headache with chest tightening, shortness of breath, hard time swallowing and a pulsating pain on the back of my head. This lasted four days before it eased. Also, I have been feeling run down and headaches since.
51 2021-05-24 tingling, involuntary muscle movements, numbness On and off numbness and tingling in my left arm and hand (primarily) and also in my right hand (a f... Read more
On and off numbness and tingling in my left arm and hand (primarily) and also in my right hand (a few times) during the day for about 3 weeks. Involuntary movements in my fingers in both hands. My arms and hands still fall asleep at night and this did not happen to me before except on some rare occasion that I slept on my hand or arm. I have been awoken by a limb that is asleep about 4 times since my vaccine. Intermittent headaches for about two week after the vaccine and a very unusual, heavy and somewhat painful period with several large clots the size of a half dollar and lasting much longer than a normal period. I felt dizzy and lightheaded for about a day. I have never had these kinds of periods before.
51 2021-05-25 weakness Heart Rate fluctuations (64-110 bpm); Chills; abdominal cramping; Extreme diarrhea; Weakness; Nausea... Read more
Heart Rate fluctuations (64-110 bpm); Chills; abdominal cramping; Extreme diarrhea; Weakness; Nausea; This is a spontaneous report from a contactable Heath care professional, the Nurse. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EN6208), via an unspecified route of administration on Right Arm on 16Mar2021 at 17:15 hours (at the age of 51-years-old and the patient was not pregnant at the time of vaccination) as a single dose for COVID-19 immunization. Medical history included Seasonal Allergies and No other biomedical health issues were reported. Weight 119 lbs, small body frame. Past drug history have not been provided. Concomitant medications included Xzal, Vit B complex, Vit D, Vit C taken within two weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccine within four weeks. Since the vaccination, patient has not been tested for COVID-19. On 16Mar2021 at 21:15 hours, patient experienced Sudden Nausea, Abdominal cramps and Extreme Diarrhea with complete emptying (similar to a colonoscopy preparation) and also Chills, without fever, Weakness, and Heart Rate fluctuations with 64-110 beats per minute. The patient did not receive any treatment for adverse events. The clinical outcome of the all events were recovering. No follow-up attempts are needed. No further information is expected.
51 2021-05-25 weakness 5/22/2021 - Day after vaccine I experienced the following: Sore arm at injection site. Extreme fatig... Read more
5/22/2021 - Day after vaccine I experienced the following: Sore arm at injection site. Extreme fatigue. Moderate body aches. Headache. Chills. Nausea. Fever. 5/23/2021 - 2nd day after vaccine I experienced the following: Moderate Fatigue. Weakness. Mild body aches. Mild breathing difficulty. 5/24/2021 - Had to take the day off from work as weakness/fatigue and overall residual malaise from the prior 2 days took its toll.
51 2021-05-25 pain in extremity I had the "normal" aches and tiredness starting many hours after 2nd shot (1st shot only had the ver... Read more
I had the "normal" aches and tiredness starting many hours after 2nd shot (1st shot only had the very sore arm/unable to lift left arm straight up on the second and third day). Went to bed around 10pm. Slept hard and woke up at 12:05am the next morning with EXTREME convulsing chills and clearly had a very high fever. I didn't have a thermometer to check, but had the old fashioned second person feel my forehead and cheeks. Teeth were chattering, literally. Every joint in my body and muscles ached and i felt extremely arthritic. Woke up in a pool of sweat maybe 24 hrs after 2nd shot. Slept on-and-off all day. Second morning after still had the chills/sweating. Still had arthritic-feeling joints on day 2. What is scaring me is that it has been 16/17 days later and I still have a constant dull ache in my left shoulder with a dull ache/weekness in my left hand.
51 2021-05-25 pain in extremity Slight inflammation at injection site; pain and weakness upper left arm; fatigue; tiredness, slight ... Read more
Slight inflammation at injection site; pain and weakness upper left arm; fatigue; tiredness, slight nausea
51 2021-05-25 tingling, numbness Right arm swelled up within 5 minutes after shot, hard to move fingers with the swelling. Tingling,... Read more
Right arm swelled up within 5 minutes after shot, hard to move fingers with the swelling. Tingling, numbness. Next day intense pain at injection site, but swelling had gone down. Trouble sleeping first 3 nights after vaccine. Pain at injection site lasted until 4 days later when right shoulder joint began to hurt causing limited mobility. 7 days after vaccine lymph nodes very swollen and tender in left armpit and large swollen nodule next to right ear on scalp appeared. 9 days after vaccine still having pain and mobility issues with right shoulder. Have been generally fatigued, harder to exercise in the days after the vaccine.
51 2021-05-26 feeling cold Feeling terrible; Chills; Achiness; headache; Neck pain; Hip Hurts; freezing; This is a spontaneous ... Read more
Feeling terrible; Chills; Achiness; headache; Neck pain; Hip Hurts; freezing; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received second dose of bnt162b2 (PFIZER-Biontech Covid-19 Vaccine, Solution for injection, Lot Number: EW0182, Expiration date: 31Aug2021), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 18:30 (Batch/Lot Number: EW0182; Expiration Date: 31Aug2021) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14May2021, the patient experienced feeling terrible, chills, achiness, headache, neck pain, hip hurt, freezing. Caller reported dry skin and scaling inside to the outside of the ear after receiving the first dose of the Pfizer COVID-19 vaccine. She mentioned it's getting worst since the second dose. Caller is calling about the vaccination. She clarified it as the Covid vaccine. She is curious about the side effects. She got this on Thursday and still feels terrible. She still feel chills and achiness and freezing. She feels terrible from Thursday and everything is hurting her. The other thing, its a weird thing did anyone report dry and scaly-ness on the ear. She mentioned it to her cousin and her cousin mentioned she felt terrible as well and has Hives on her ears. They both had the same thing- dry skin and scaly-ness from the inside of the canal to the outside. She would like to know how to treat it. She has been putting things on it and its not going away and she wanted to know if someone else had the same thing. The other thing, its a weird thing did anyone report dry and scaly-ness on the ear. She has been putting things on it and its not going away and she wanted to know if someone else had the same thing. Feeling terrible treatment: no she thought it would wear off, it has been going on since thursday and now its monday, time: 1pm on Friday. For the chills treatment: she has been putting on extra cloths, time: she does not know exact time on Friday. Achiness treatment: none, time: friday in the afternoon. Headache, treatment: none, time: Friday in the afternoon. Neck pain caller stated its ongoing, outcome of event: Attempted to clarify with caller she stated she she still has it. It's not as bad as it was, treatment: none, time: Friday in the afternoon. Hip hurt caller stated it went away, outcome: caller stated unknown, treatment: none, time: afternoon. Dry and Scaly-ness of the Ear: Start - caller stated this is the second dose that started. The first dose she had 3 weeks ago. Stop - Its ongoing. Its gotten worse she is wondering if its related to the second dose of the vaccine. Treatment: steroid cream. She had it prescribed for something else. It didn't go away. She though it may heal this sore too. serial by the barcode - 51672404819. NDC: Prescription label on product. Caller unable to find NDC at this time. lot: 342227, exp: 09/2022, time: from the first one not the last one her ears are itching more since the second one. The clinical outcome of feeling terrible, chills, headache, freezing were not recovered, of the achiness, neck pain were recovering and of the hip hurts was unknown. Follow up attempts are needed. Further information has been requested.
51 2021-05-26 muscle twitching Twitching below right eye on right cheek; This is a spontaneous report from a contactable consumer, ... Read more
Twitching below right eye on right cheek; This is a spontaneous report from a contactable consumer, the patient. A 51 years old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Batch/lot Number: EN6200) via an unspecified route of administration on left arm as single dose on 02Mar2021 at 19:30 (at the age of 51-years-old) for COVID-19 immunization. The patient's medical history included chronic migraine, twitching on eye and Gastroesophageal reflux disease (GERD). The patient previously took penicillin, codeine and Diflucan, and developed allergy to all the three drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications include Famvir, Celebrex, Wellbutrin, atenolol, and Emgality. On 03Mar2021, the patient experienced twitching below right eye on right cheek, which would come and go. The patient felt like she was having a transcutaneous electrical nerve stimulation (TENS) unit on her face. The patient also felt it was very different to a twitch she would get on her eye. The patient did not receive any treatment for the event. The event twitching below right eye on right cheek was not resolved. No follow-up attempts are needed. No further information is expected.
51 2021-05-26 muscle twitching Red face; Right inner cheek twitching; This is a spontaneous report from a contactable consumer (pat... Read more
Red face; Right inner cheek twitching; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 22Feb2021 10:30 AM (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included known allergies to sulfa. The patient previously took levofloxacin and levaquin experienced allergy. Concomitant medications included zinc; krill oil; citalopram and multivitamin. No other vaccine in four weeks. The patient experienced right inner cheek twitching on 22Feb2021 and on 23Feb2021 10:30 patient had red face sun sensitivity which appeared after 24 hours and is warm to touch. There was no covid prior vaccination and covid not tested post vaccination. There was no treatment received. The outcome of event right inner cheek twitching was recovered on 23Feb2021 and outcome of event red face was unknown. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
51 2021-05-27 face paralysis, facial paralysis, bell's palsy Bell?s Palay being treated with Prednisone and Valtrex. Right side of face weakness/paralyzed. Prese... Read more
Bell?s Palay being treated with Prednisone and Valtrex. Right side of face weakness/paralyzed. Presented with neck and shoulder pain at onset. Unsure if the vaccine is the cause.
51 2021-05-27 muscle twitching intermitent shoulder muscular twitching
51 2021-05-27 pain in extremity This report supplements the report previously provided, as I cannot recall whether I provided a full... Read more
This report supplements the report previously provided, as I cannot recall whether I provided a full accounting of my side effects. In addition to sore arm and fatigue, I experienced abdominal discomfort, similar to menstrual cramps (although I have had a hysterectomy) throughout the day for several days. I also had issues with decreased urine output and slower/decreased urine stream, despite drinking the usual amount of water. Although, for the past at least two years, I normally wake every night in the middle of the night with an urge to urinate, that did not occur beginning the evening I received the first dose of the vaccine and lasting approximately one week. I was concerned about a bladder or kidney issue, but I did not have this same issue after the second dose of the vaccine.
51 2021-05-28 cold sweat, feeling cold Patient received the 1st COVID vaccine ( Pfizer, lot # EW0185, use by 06/24/21 at 0845) at 1313. Cli... Read more
Patient received the 1st COVID vaccine ( Pfizer, lot # EW0185, use by 06/24/21 at 0845) at 1313. Client reported to EMT that she felt a headache coming on, and was a little nauseous. The client was given a bottle of water and RN was notified immediately. RN assisted the client to the anti-gravity chair, was placed in a semi-fowler's position, while RN assessed the client. The client was alert and oriented x 4. Vital signs were taken simultaneously at 1400, HR- 84, RR-16, BP-158/90, oxygen saturation at 98%. At 1402 the client stated, " My headache is a little better and my nausea is gone." Denied shortness of breath, chest pain, difficulty swallowing, lightheadedness, or feeling flushed. Denied drinking much water prior to coming to the site. Vital signs taken at 1405, HR- 86, RR-16, BP- 160/88, oxygen saturation at 99%. Client reported having an allergic reaction to codeine (anaphylaxis) and having type II diabetes mellitus, asthma, and a heart murmur. The client reported currently taking singulair, victoza, trulicity, lantus, metformin, and fenofibrate. Vital signs taken at 1410, BP- 160/88,HR-87, RR-16, oxygen saturation at 98%. The client was speaking in full sentences and was in no apparent distress. The client continued to drink water. The client reported not seeing a primary care provider for over a year. Denies any vision changes, headache, or lightheadedness. Vital signs taken at 1415, BP- 160/ 88, HR- 86, RR-16, oxygen saturation-98%. RN educated the client about V-safe, Emergency Room precautions, and to follow up with her primary care provider. RN advised the client to stay on site until 1430. The client stated, " I might be a little anxious, I'm sorry, I'm not trying to be a bother." The client was reassured to always tell the medical personnel on site if she felt unwell in anyway. EMT and PM remained in the observation area. At 1431, the client stated, " I feel a flutter in my chest that feels bounding." The client was cold and clammy, RN called 911 immediately at 1431. Vital signs taken at 1431, BP- 156/84, HR-83, RR-18, oxygen saturation- 99%. The client remained in the semi-fowler position, was alert and oriented x4, and was speaking in full sentences. Denied difficulty breathing, vision changes, shortness of breath. No rash or hives were present. Vital signs taken at 1436, BP- 140/88, HR- 80, RR-16, oxygen saturation- 99%. Client stated, " The heart fluttering is feeling better." The client was no longer cold or clammy. Vital signs taken at 1441, BP- 142/88, HR- 82, RR-16, oxygen saturation- 99%. EMS arrived on site at 1443. The firefighter/paramedic assessed the client, had the client stand up from the anti-gravity chair, asked her how she felt, and she stated, " I feel a lot better." The firefighter/ paramedic asked the client if she still had the fluttering sensation in her chest, the client stated, " No." The EMS team did not complete a set of vitals or complete an EKG on the client. The firefighters left the site at 1447. RN re-educated the client about following up with her primary care provider and educated the client about emergency room precautions. Client ambulated to her car where her family members were waiting for her, she had an even and steady gait.
51 2021-05-28 flushing headache; experienced flushing; light headed; This is a spontaneous report from a contactable Consum... Read more
headache; experienced flushing; light headed; This is a spontaneous report from a contactable Consumer (Patient). A 51-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), unknown single Solution for injection, Lot number EN6203) via an unspecified, route of administered in Left arm on 27Feb2021 11:15 AM (at the age of 51-years-old) at a single dose for COVID-19 immunization. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included asthma, Known allergies cephalosporins, erythromycin, sulfa and concomitant medications included Allegra, Symbicort, Nexium, Flonase (medications in two weeks). On 27Feb2021 11:30 Within 10 minutes patient began to have a headache, began feeling light headed and experienced flushing. EMT checked and O2 was 97, heart rate 82, BP was 132/78. No wheezing or swelling. Patient had no treatment. Patient did not test the COVID-19 test prior vaccination and Not tested covid post vaccination. Outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
51 2021-05-28 pain in extremity, hot flush headache; sweats/hot flashes; sweats/hot flashes; ringing of ears that are still happening 4 days la... Read more
headache; sweats/hot flashes; sweats/hot flashes; ringing of ears that are still happening 4 days later; arm pain from shot but now seems ok; This is a spontaneous report from a contactable consumer. A 51-years-old female patient reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 14:00 (Batch/Lot Number: EN6203) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); omeprazole (PRILOSEC [OMEPRAZOLE]). The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 03Mar2021, the patient experienced headache, sweats/hot flashes, ringing of ears that were still happening 4 days later, arm pain from shot but now seems okay. The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.
51 2021-05-28 pain in extremity sore arm; Headache and dizziness as if I had hit my head or got anesthesia and was about to go out; ... Read more
sore arm; Headache and dizziness as if I had hit my head or got anesthesia and was about to go out; Headache and dizziness as if I had hit my head or got anesthesia and was about to go out; feeling of heaviness/heaviness in my head; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration, administered in left arm on 01Mar2021 at 13:00 (at the age of 51-year-old) at a single dose for covid-19 immunisation in workplace clinic. Medical history included hypothyroidism and autoimmune disorders. Patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID) at a dose of 112 mg daily, calcium and vitamin supplement. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021 at 13:15, minutes after vaccination when the patient was sitting in the waiting/observation area the patient experienced headache and dizziness as if the patient had hit her head or got aneathesia and was about to go out and had feeling of heaviness/heaviness in her head. Patient stayed a bit longer when she thought she could leave 15-20 minutes after the feeling started to subside and but when she tried to walk and go upstairs dizziness and feeling of heaviness was persisted, got better with lots of water. Overall, about 2 hours later around 3- 3.30 pm she was feeling better and went home. That evening around 8 pm, she felt ok without the dizziness or heaviness in her head. She only had a sore arm and was ok the next day. No treatment was received to the patient for the events. The outcome of event sore arm was recovering, rest of the events was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-05-29 pain in extremity Between 24-48 hours began have reactions not expected. Pain in LEFT foot and toes. Severe pain in LE... Read more
Between 24-48 hours began have reactions not expected. Pain in LEFT foot and toes. Severe pain in LEFT hand, fingers, wrist, and forearm. Then pain in BOTH wrists, hands, feet, and then lower back pain. The pain moved from scary levels to dull pain over the 2 weeks post-vaccination. I expect the pain will go away soon. The use of my hands was affected. Walking was affected. It felt like the lymph nodes around my ears, neck, face, eyes, chest, arms, abdomen, legs were all swollen. Can swollen lymph cause carpal tunnel like symptoms? Foot pain? Lower back pain? Began to have allergic like skin reactions 5 days post-vaccination. Burning eyes, itchy skin. Still experiencing itchy skin with red/warm face 13 days post-vaccine. Antihistamine relieves most symptoms. This vaccine does not seem sustainable for me as a yearly vaccine. (I had red palms after the 1st vaccine within hours. I am not sure if this was a reaction to the vaccine. I began taking antihistamine before the 2nd vaccine and did not get red palms. I have no idea if red palms were an early hint that I would be hyper sensitive to the vaccine.)
51 2021-05-29 pain in extremity 1st shot just arm soreness and metal taste in mouth 2nd shot subconjuctival hemorrhage 6hrs post inj... Read more
1st shot just arm soreness and metal taste in mouth 2nd shot subconjuctival hemorrhage 6hrs post injection. start of menstral cycle 9hrs post injection
51 2021-05-31 burning sensation, pain in extremity Client developed a reaction to 2nd dose of COVID-19 vaccine. Client described symptoms as a burning... Read more
Client developed a reaction to 2nd dose of COVID-19 vaccine. Client described symptoms as a burning sensation on top of her left hand. At 8:32am on 6/1/21. Client refused vital signs. Ice pack was given. Client verbalized feeling better. Client exited the facility at 8:50am.
51 2021-05-31 flushing Patient has a history of autonomic dysfunction and 1 minute post administration of Pfizer vaccine pa... Read more
Patient has a history of autonomic dysfunction and 1 minute post administration of Pfizer vaccine patient began to feel lightheadedness and flushing. VS: 157/92, P 88, O2 98%, Resp 18. Patient remained in Observation area for an extended period of time. Left clinic in stable condition.
51 2021-06-01 feeling cold The patient received the first dose of covid vaccine at 10 am then went to her car at 10:30 am. Came... Read more
The patient received the first dose of covid vaccine at 10 am then went to her car at 10:30 am. Came back into the monitoring area at 11 am complaining of numbness and tingling around the lips. Patient states 'a general coldness." The patient was given 25 mg of Benedryl. The Benedryl didn't make things better but the symptoms didn't worsen.
51 2021-06-01 feeling of body temperature change first evening I felt woozy, vertigo. Morning after had mild headache, general aches and difficulty c... Read more
first evening I felt woozy, vertigo. Morning after had mild headache, general aches and difficulty controlling body temperature. Hot to cold. Lasted 3 days then eased. However, the vertigo is not going away and I am 9 days passed vaccination.
51 2021-06-01 tingling Had severe tingling and muscle tightening in left arm; Had severe tingling and muscle tightening in ... Read more
Had severe tingling and muscle tightening in left arm; Had severe tingling and muscle tightening in left arm; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. This 51-year-old female patient received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0172) via an unspecified route of administration on 28Apr2021 at 08:45 (at the age of 51-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies, anxiety disorder, gastroesophageal reflux disease (GERD), hysterectomy, and allergy to sulfa drugs. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included omeprazole, estradiol patch, fexofenadine hydrochloride, and duloxetine hydrochloride (CYMBALTA) from unknown dates for unknown indications. The patient previously received bupropion (WELLBUTRIN) and clarithromycin (BIAXIN) from unknown dates for unknown indications and experienced allergy and "shingles" on an unknown date and had a similar experience. The patient previously received dose 1 of BNT162B2 on 07Apr2021 at 09:00 (lot number EW0150) as a single dose in the right arm for COVID-19 immunization. On 30Apr2021 at 00:30 the patient experienced severe tingling and muscle tightening in her left arm which felt like possible heart attack. The event was reported as non-serious. The patient visited the emergency room (ER) as a result of the events and it was confirmed negative for thus but discussed that it felt similar to her "shingles experience" which was also in her left arm. The patient did not receive any treatment for the events. The outcomes of tingling and muscle tightening were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
51 2021-06-02 bell's palsy Was diagnosed with Bell's Palsy on 11May2021; This is a spontaneous report from a contactable consum... Read more
Was diagnosed with Bell's Palsy on 11May2021; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6205), at the age of 51-year-old, via an unspecified route of administration, administered in Arm Right on 08Mar2021 08:30 at single dose for COVID-19 immunisation. Medical history included migraines, low thyroid, high blood pressure (BP)/cholesterol and mild depression/anxiety. Known allergies: ciprofloxacin (CIPRO). Concomitant medications included levothyroxine; atorvastatin (reported as gen Lipitor's); propranolol; doxepin. The patient also received unspecified CY within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN5318) on 15Feb2021 at 08:00 AM, at the age of 51-year-old, via an unspecified route of administration, administered in Right arm, for COVID-19 immunisation. The patient was diagnosed with bell's palsy on 11May2021, and the event onset date reported as 10May2021 13:00. The patient underwent lab tests and procedures which included Nasal Swab: negative (COVID test post vaccination). The event resulted in Emergency room/department or urgent care. Treatment received for the event that included steroids and anti-virals. The patient had doctor (DR) appointment on 21May2021. The outcome of the event was not recovered.
51 2021-06-02 cold sweat soreness under her armpit; pain at the front and top of her head; cold sweats; chills; This is a spo... Read more
soreness under her armpit; pain at the front and top of her head; cold sweats; chills; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female consumer patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided), via an unspecified route of administration, on 04Mar2021 (at the age of 51-years-old) as a single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date, as reported, patient was still experiencing soreness under her armpit where she had the injection, pain at the front and top of her head, cold sweats and chills. The reporter asked was this common and when should she be concern. The reporter asked a question that can she take Tylenol after receiving the Pfizer Covid-19 vaccine. The outcome for the events were not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
51 2021-06-02 feeling hot On June 1, 2021 at approximately 1500 hours, patient received the Pfizer-BioNTech) vaccination. At a... Read more
On June 1, 2021 at approximately 1500 hours, patient received the Pfizer-BioNTech) vaccination. At approximately 1517 hours, the attendee abruptly left the observation area quickly moving toward the restroom. Registered Nurse observed this reaction and immediately followed behind the attendee to the restroom. The attendee vomitted a small amount of fluid at this time and was escorted back to the observation area. At approximately 1520 hours, vitals signs were taken with the result of BP:128/78, HR 90, SPO2 99, Temp 97.9. At approximately 1525 hours, the attendee reported an itchy sensation on the left side of her throat and subjective symptoms dizziness and warmth. The attendee was administered 50 mg of Benadryl at this time and instant ice packs were applied to the back of the neck. Symptoms resolved within minutes and the patient was released home with instructions about adverse effects and when to seek medical attention.
51 2021-06-02 hot flush Client received 1st COVID vaccine of Pfizer (Lot# EW0182, expiration 06/28/2021). At 1653, Client st... Read more
Client received 1st COVID vaccine of Pfizer (Lot# EW0182, expiration 06/28/2021). At 1653, Client states that she is dizzy and has "hot flashes". At 1654, RN, RN, and RN responded to this event and transferred Client to the anti-gravity chair. At 1654, RN and PHN responded and began assessment. At 1654, vital signs are blood pressure is 180/100, heart rate 74, oxygen saturation 99%. Client reports the dizziness and hot flashes resolved in seconds. Client reports being recently diagnosed with hypertension two months ago, but is not on medication. Client states "I refuse to take medication". At 1656, blood pressure was rechecked on opposite arm and is 182/104. At 1657, blood pressure is 182/110. At 1701, PHN and RN educate Client on hypertension, ED precautions, and common adverse effects of the COVID vaccine. At this time, PHN offers Client emergency services, but Client declines. PHN and RN advises Client to follow up with primary care provider. At 1710, vital signs are blood pressure 182/102, heart rate 75, oxygen saturation 98%. At 1711, Client stood up with no complains and with resolved symptoms. Client left against medical advise to stay in observation for an addition 30 minutes. Client walked out of facility with a steady gait at 1711, and states "I will make an appointment with my provider tomorrow".
51 2021-06-02 numbness, feeling jittery Jittery; Allergic reaction - minor; left sided numbness; shortness of breath; chest pain; blood pres... Read more
Jittery; Allergic reaction - minor; left sided numbness; shortness of breath; chest pain; blood pressure elevated/ greater than 200; This is a spontaneous report from a contactable consumer (patient) and a physician. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot Number: EW0172; Expiration Date: Aug2021) as 1st dose, single for Covid-19 immunization. Medical history included lung cancer from Aug2008 (in remission), surgery to remove half of the upper lung (where the cancer mass was and also all of lymph nodes in upper left lung area), and allergies to pollen, bee sting, dust and dust mites. Concomitant medications included levocetirizine dihydrochloride (LEVOCETIRIZIN); losartan potassium; montelukast sodium. On 22Apr2021, the patient experienced jittery (1 hour after vaccination) and allergic reaction - minor, left sided numbness, shortness of breath, and chest pain. EMS was called vitals shown blood pressure elevated and greater than 200. patient was given famotidine (PEPCID) (oral, 20 mg, 2x/day for 3 days), diphenhydramine hydrochloride (BENADRYL) (oral, 25 mg, 1x/day every 6 hours for 5 days) and prednisone (oral, 20 mg, single for 2 days) for these vaccine reactions. Events required visit to Emergency Room. Patient got the vaccine because she was high risk for Covid 19 but now she does not plan on getting the 2nd vaccine for fear it would kill her. The outcome of events was unknown.
51 2021-06-02 pain in extremity, muscle twitching HEADACHE, sore arm, right bicep twitching, body aches, very tired.
51 2021-06-03 discomfort swollen lymph node in RT side of the neck; extreme discomfort; producing an earache; sore neck/shoul... Read more
swollen lymph node in RT side of the neck; extreme discomfort; producing an earache; sore neck/shoulder x 3 days which began the day after the injection; sore neck/shoulder x 3 days which began the day after the injection; This is a spontaneous report from a contactable other hcp (patient). A 51-years-old (non-pregnant) female patient received BNT162B2 (BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), dose 1 intramuscularly, administered in Arm Left on 04Mar2021 11:30 (at the age of 51-years-old) as SINGLE DOSE for covid-19 immunization at School or Student Health Clinic. The patient was not pregnant at the time of vaccination. Medical history included fibromyalgia, migraine, attention deficit hyperactivity disorder, drug hypersensitivity (sulfa allergy) with supplementation therapy from an unknown date. Concomitant medications included pregabalin (LYRICA), naproxen (NAPROXEN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), cetirizine hydrochloride (CETRIZINE), vitamin b complex (VIT B COMPLEX), calcium (CALCIUM) tizanidine (TIZANIDINE); quetiapine fumarate (SEROQUEL) was taken for an unknown indication from an unknown start date at an unknown dose and magnesium (MAGNESIUM) taken for supplementation therapy, from unknown start date. The patient had not covid prior vaccination. The patient did not have any other vaccine in the past four weeks. On 05Mar2021 08:00AM, the patient experienced swollen lymph node in RT side of the neck, extreme discomfort, producing an earache and sore neck/shoulder for 3 days which began the day after the injection. The patient did not receive any treatment for events. The patient was not tested for covid post vaccination. The outcome of the events was reported as recovering at the time of report. No follow-up attempts are possible. No further information is expected.
51 2021-06-03 migraine I had petechia / Purpura on my lower legs, both and thought perhaps a rash, yet did not itch nor go ... Read more
I had petechia / Purpura on my lower legs, both and thought perhaps a rash, yet did not itch nor go away when pressed my skin about 10 days after my Vaccine. I thought perhaps it was the new medication Spironolactone I began the 24 th, 3 days after the Pfizer Vaccine, yet My Dr did not believe so with the dose and never had seen. I stopped the Spironolactone the 5th of April and had a biopsy the 9th and blood and urinalysis .. Dr. stated my tests came back normal, and wanted me to go to my Primary care Dr. and not resume Sprionoloctane MY primary Dr. recommended my not receiving the 2nd Covid vaccine dose I decided I would not anyhow Note I had Covid 19 April 30 2020 I took upon myself May 22nd to retake Spironolactone and I have bee n on for over two weeks and zero reactions.. Concluding it was the vaccine which caused the Petechia as I have zero marks on my legs I had a consult with My Primary Dr who informed me to contact you and make a statement. Apart from the above the moring after Vaccine I spriked a fever and was ill the following day. I also had extreme exhaustion , joint pain and my migraines have worsened to point I had to cut my work hours and I may lose my Health Insurance. I am not recovered fully.. The petechia resolved in 2 weeks without the suggested steroid cream prescribed for me
51 2021-06-03 tingling, numbness, facial pain, facial paralysis, slurring States her cholesterol is always 75 and is now 200; facial droop or pain in her face; noticed her ar... Read more
States her cholesterol is always 75 and is now 200; facial droop or pain in her face; noticed her arms started getting numb and swelling up; noticed her arms started getting numb and swelling up; facial droop or pain in her face; talk with the slur; tingling in her fingers; ended up in the emergency room and had a stroke; she had blood clots on the brain from the stroke; she went into the ER her blood pressure was 200/180; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 51-year-old female patient received bnt162b2 (Lot Number: ER8730; Expiration Date: 31Jul2021), second dose via an unspecified route of administration, administered in left arm on 11Apr2021 (early in the morning) at the age of 51-year-old as 2nd dose, single for covid-19 immunization. Medical history included ventricular septal defect from an unknown date and unknown if ongoing (she was born with a hole in her heart but that had closed up and when she had the stroke, the hole opened back up and they told her she had blood clots on the brain from the stroke). There were no concomitant medications. The patient previous received first dose of bnt162b2 (Batch/Lot Number: ER2613; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 21Mar2021 single dose for covid-19 immunization. The patient experienced stroke on 20Apr2021, she had blood clots on the brain from the stroke on 20Apr2021, blood pressure was 200/180 on 20Apr2021, her cholesterol is always 75 and is now 200 on an unspecified date, facial droop on an unspecified date, her arms started getting numb and swelling up on an unspecified date, pain in her face on an unspecified date, talk with the slur/ slurred speech on an unspecified date. The events her arms started getting numb and swelling up, pain in her face and talk with the slur/ slurred speech were serious per hospitalization; stroke, she had blood clots on the brain from the stroke, blood pressure was 200/180, her cholesterol is always 75 and is now 200 and facial droop were serious per hospitalization, medically significant. The patient was hospitalized for from 20Apr2021 to an unknown date. The events require a visit to emergency room and physician office. Caller states she is calling about the Pfizer shot and had the 2nd dose on 11Apr2021 and noticed her arms started getting numb and swelling up and she did not do anything about it but 2 days after that she called the facility where she had the Pfizer shot and they said to call her HCP and the HCP was out of town so she spoke with a nurse and was told to go to urgent care at that time. States she went to urgent care and they said her arm was swollen and to rub alcohol on it and she did that and a couple of days after that ended up in the emergency room and had a stroke. States the numbness and swelling was just the whole left side of her body and she went to the emergency room at the hospital on 20Apr2021 but on 16Apr2021 she went to the urgent care; states the numbness and swelling is better but comes and goes with the tingling in her fingers and the numbness, but her face is doing much better and she does not have the facial droop or pain in her face anymore; states her speech is back and she does not talk with the slur anymore. States the facial droop, face pain and slurred speech began when she went to the ER and that was on 20Apr2021 and is now completely resolved. Caller states the 1st dose of her Pfizer Vaccine was administered on 21Mar2021 with lot ER2613, the 2nd dose was administered on 11Apr2021 with lot ER8730; states both doses of the Pfizer Vaccine were administered in her left arm and her patient card does not have the NDC written on it but the expiry date for both doses of the vaccine is 31Jul2021. States the whole year of 2020 she was doing fine till she took the Pfizer Vaccine and that shot everything up regarding her cholesterol levels and Blood pressure which are all high; states her cholesterol is always 75 and is now 200; states she has high blood pressure and when she went into the ER her blood pressure was 200/180; states she was born with a hole in her heart but that had closed up and when she had the stroke, the hole opened back up and they told her she had blood clots on the brain from the stroke. The patient underwent lab tests and procedures which included cholesterol: 200 on 10May2021 (her cholesterol is always 75 and is now 200), blood pressure: 200/180 on 20Apr2021. The outcome of events for stroke, she had blood clots on the brain from the stroke, her blood pressure was 200/180, her cholesterol is always 75 and is now 200, tingling in her fingers were unknown, for other events was resolved on an unspecified date. Vaccination Facility Type: school. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks).
51 2021-06-03 tingling, numbness the right side of my face became numb/tingly; the right side of my face became numb/tingly; This is ... Read more
the right side of my face became numb/tingly; the right side of my face became numb/tingly; This is a spontaneous report from a contactable consumer. A 51-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Mar2021 at 17:30 at single dose in right arm for COVID-19 immunisation at the age of 51-year-old. Lot number EN6202. Medical history included sleep apnea, asthma, allergy to sulfa, grass allergy, allergy to molds, Pollen allergy. The patient was not pregnant. Historical vaccine included TDAP on 18Feb2021 in right arm. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), fluticasone furoate (ARNUITY ELLIPTA), montelukast sodium (SINGULAIR), ergocalciferol (VIT D). The patient waited 30 minutes after injection because she did do get allergy injections so the patient was just being extra cautious. On 04Mar2021, at 18:15, after we left the right side of face became numb/ tingly. It lasted probably an hour. The patient was not treated due to the events. The patient recovered from the events on unknown date. No follow-up attempts are needed. No further information is expected
51 2021-06-05 pain in extremity Big Swelling and not going down since injection for my second shot and is painful sometimes Has not... Read more
Big Swelling and not going down since injection for my second shot and is painful sometimes Has not sort treatment but sometimes take pain medication (Aleve)
51 2021-06-05 tenderness adverse events: 20 hours after 2nd dose: 1.classic drug rash across torso and abdomen (small red do... Read more
adverse events: 20 hours after 2nd dose: 1.classic drug rash across torso and abdomen (small red dots that itched some all over the areas involved) 2. Pain like fire in all joints 3. unable to walk on feet without pain and fire shooting out form inside 4. unable to touch many spots on body; slightest pressure felt as respiration-changing pain 5. muscle groups muscles firm/ hard/tight (confirmed by physician at appt on monday 5/3), 4 days later treatments: day 1 of symptoms: toradol. numbed pain for a few hours for each dose. Pain did not recede day 4 of symptoms: dr. prescribed course of prednisone. Pain improved slightly but still not able to walk on feet day 10 of symptoms: dr prescribed 2nd course of prednisone; pain continues to improve but still unable to walk on feet in am and last pm, and continuing pain in right achilles area and left outside midsole as well, altering ability to wear socks touching or shoes touching the areas. day 20 of symptoms; Both prednisone courses complete: joints pain and pressure points move from joint to joint; unable to walk on feet in am and if ieated at table or driving for more than 60 minutes. continuing pain in right achilles area and left outside midsole as well, altering ability to wear socks touching or shoes touching the areas. day 30 of symptoms:: there is a palpable hard area on outside of left midsole day 36 of symptoms : making another dr. appointmento follow up on footman, ability to walk, joint pain, and palpable hard area on left foot. no fever, no hot areas;
51 2021-06-06 tingling, electric shock sensation Progressive and relatively constant tightness in chest. Fluttering and skipped beats after eating, ... Read more
Progressive and relatively constant tightness in chest. Fluttering and skipped beats after eating, exertion, alcohol, caffeine and often when lying down in night and morning. One intense episode of electricity washing over body. Mild tingling washing over body. Various other times. Zero health issues, zero heart risk factors. Husband is experiencing similar episodes a week after mine. Also vaccinated a week after me. His mother was seen for same symptoms in clinic and her doctor said many are reporting this.
51 2021-06-06 tingling Initially slight headache, 5hrs later difficulty moving from waist down, 4/18/21 - tingling from wai... Read more
Initially slight headache, 5hrs later difficulty moving from waist down, 4/18/21 - tingling from waist down, went to ER no reflex response in both knees, 4/19/21 tingling in both arms, over a period of six days severe headache, lower body weakness, nausea. When discharged still lower body weakness. Since that time in May experienced 5/2021 complex hemiplegic migraine, lower body weakness waist down. Presently 6/2021 still lower body weakness and severe hemiplegic migraine, blurred vision.
51 2021-06-06 throat numbness, numbness 5 minutes following the shot in my left arm, the left side of my throat, tongue and face (from under... Read more
5 minutes following the shot in my left arm, the left side of my throat, tongue and face (from underneath eye, down to mandible, across from ear to nose) went numb. Feeling was similar to that of being frozen for a dental procedure. It lasted 48 hours. My left hand and foot also went numb and remain mildly numb. Similar to feeling I had when my spinal court tumor was discovered 15 years ago. Post resection, it subsided as pressure on nerves was alleviated. Very scary. I won?t return for a second shot.
51 2021-06-07 muscle spasms Vaccination site is red; Vaccination site swollen; Vaccination site warmth; Vaccination site pain; V... Read more
Vaccination site is red; Vaccination site swollen; Vaccination site warmth; Vaccination site pain; Vaccination site has a hard lump; Bloating; Cramps; diarrhea; Gas; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown) via an unspecified route of administration on the left arm on 13Mar2021 at 04:30 AM (at the age of 51-years-old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. Medical history included urticaria. The patients allergies included pollen and dust. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 2 weeks prior to the COVID-19 vaccine. On 14Mar2021 at 06:00 AM, patient noted that vaccination site was red, swollen, warm, painful, with a hard lump, bloating, cramps, diarrhoea and gas. No therapeutic measures were taken as a result of the events experienced. The clinical outcome of the events vaccination site red, swollen, warm, painful, hard lump, bloating, cramps, diarrhoea and gas was not recovered at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
51 2021-06-08 inability to speak Patient received 2nd dose of Pfizer via left deltoid. Approximately 25 minutes later, patient was c... Read more
Patient received 2nd dose of Pfizer via left deltoid. Approximately 25 minutes later, patient was coughing and had difficulty speaking in full sentences and had audible wheezing. Pt also complaining of pruritis to injection site. Approximately 27 minutes post vaccination, pt's 02 sat went from 99% RA to 95% RA. At that point, pt was given supplemental 02 via NRB, pt took her own 12.5mg Benadryl tablet and was given a cold pack. Pt conditioned worsened, Epinephrine autoinjector IM given to right thigh. 02 sat went back up to 99%. EMS arrived on site, pt received duoneb and IV Benadryl 37.5mg, IVP 125mg Solu-medrol. Pt able to speak in full sentences upon departure to ED. Vital signs: 1650 bp 160/98, HR 104, 02 99% RA, RR 10. 1700: bp 160/85, 02 95% RA, HR 107, RR 10. VS after Epinephrine administered, 02 sat returned to 99% on NRB, HR 140, regular rate. VS by EMS 144/84, 02 sat 98% NRB, HR 84.
51 2021-06-08 weakness fever for a day on the second day (around 14-16 hours after the 2nd dose), weak energy, pain issue w... Read more
fever for a day on the second day (around 14-16 hours after the 2nd dose), weak energy, pain issue when opening mouth or eat (like the temporomandibular joint disorder, and whenever I opened my mouth for about an inch, I would feel the pain, not to mention eating, has to eat soft food and chew slowly) for a month by now, and will go to see doctor for the reason next week.
51 2021-06-08 feeling hot, pain in extremity Within an hour of getting the vaccine, started to hurt on her right arm and then spread to her back,... Read more
Within an hour of getting the vaccine, started to hurt on her right arm and then spread to her back, swelling then started increased to softball size in rt arm. Area hard and hot. Later that night she had problems with nausea, tylenol was taken for pain. The symptoms lasted longer than a week, "I was in bed for a week, the pain in the arm lasted longer than that."
51 2021-06-08 muscle twitching Twitching in both legs, (calves, thighs, quads) beginning approx 3 weeks after second done. Seems t... Read more
Twitching in both legs, (calves, thighs, quads) beginning approx 3 weeks after second done. Seems to be worsening /progressing. The twitching is now preventing restful sleep. Present all the time now. Causing anxiety. Leading to tense muscles and fatigue.
51 2021-06-08 night sweats, pain in extremity, hot flush After my Pfizer vaccine I experienced a low grade temperature, bilateral leg and bone pain, insomnia... Read more
After my Pfizer vaccine I experienced a low grade temperature, bilateral leg and bone pain, insomnia , hot flashes, night sweats, fatigue for 3 weeks, chronic cough, fatigue 3 weeks in duration, diarrhea, stomach pain, air hunger., anxiety. body pain. joint pain have gotten worst since vaccination.
51 2021-06-08 pain in extremity, feeling cold Throwing up, hot sweating, cold ,body hurts bad headache this is all on 3rd day 2nd day just tired a... Read more
Throwing up, hot sweating, cold ,body hurts bad headache this is all on 3rd day 2nd day just tired and my arm hurts and feels like a log
51 2021-06-08 pain in extremity My left arm is weak in the muscle and in pain when I stretch it. I cannot use it the way I usto prio... Read more
My left arm is weak in the muscle and in pain when I stretch it. I cannot use it the way I usto prior to the vaccine. I cannot reach or stretch my arm the way I usto. When I sleep, I especially find it more painful, even though I have not laid on my arm. I just know factually my arm is weaker and in pain.
51 2021-06-08 pain in extremity Diarrhea 30 minutes following; Sore arm; This is a spontaneous report from a contactable consumer, p... Read more
Diarrhea 30 minutes following; Sore arm; This is a spontaneous report from a contactable consumer, patient. A 51-year-old non-pregnant female received first dose of BNT16B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), solution for injection, via an unspecified route of administration in the left arm on 18Mar2021at 14:15 (at the age 51-year-old) as single dose for COVID-19 vaccination. Medical history included Autoimmune hepatitis. The patient did not have allergies to any medications, food or other product. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were numerous. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 15:00, the patient experienced diarrhea, sore arm. The patient did not receive any treatment for the adverse events. The clinical outcome of diarrhea, sore arm was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
51 2021-06-08 pain in extremity I was fatigue and muscle aches and pain in left arm. It lasted for about 2-3 days. The first day abo... Read more
I was fatigue and muscle aches and pain in left arm. It lasted for about 2-3 days. The first day about 4hrs after getting the injection I developed a high ringing noise in my left ear and it is still present to this day. Ten days after getting the vaccine my allergies got really bad and I had to increase my meds it lasted for about three days.
51 2021-06-08 tingling tingling in finger tips; pain; swelling; fever; chills; tiredness; This is a spontaneous report from... Read more
tingling in finger tips; pain; swelling; fever; chills; tiredness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 09Mar2021 at 10:00 (Batch/Lot Number: EL3247) (at the age of 51-years-old) as first dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and Covid-19 prior to vaccination. Concomitant medications included amlodipine and carvedilol; both taken for an unspecified indication, start and stop date were not reported. On 10Mar2021 at 08:00, patient experienced tingling in finger tips, pain, swelling, fever, chills, tiredness. Patient did not received any treatment for the events. Patient had not tested for Covid post vaccination. Outcome of the events was recovering. No follow-up attempts needed. No further information expected.
51 2021-06-08 tingling Enlarge lymph node on the left neck area underneath the collarbone. Left arm had a tingling sensati... Read more
Enlarge lymph node on the left neck area underneath the collarbone. Left arm had a tingling sensation. Unable to walk on left foot due to swelling.
51 2021-06-08 tenderness, pain in extremity fatigue, arm tender, headache, pain in arm, lost range of motion, took, advil, tylenol, aleve, went ... Read more
fatigue, arm tender, headache, pain in arm, lost range of motion, took, advil, tylenol, aleve, went to urgent care on Thursday...given muscle relaxer
51 2021-06-08 tenderness Localized tenderness and a debilitating headache. It hurt to sit up and I had lymphoid in my scalp a... Read more
Localized tenderness and a debilitating headache. It hurt to sit up and I had lymphoid in my scalp and on the side of my head serve tenderness to touch and fatigue. I ran a low grade fever. Muscle pain in my scapula and left shoulder.
51 2021-06-09 bell's palsy Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-... Read more
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 06May2021 09:00 (at age 51-years-old) (Batch/Lot Number: EW0173) as 1st dose, single for covid-19 immunisation. Medical history included thyroid disorder from an unknown date and unknown if ongoing. There were no other medication received withing 2 weeks and no vaccine withing 4 weeks prior to vaccination. The patient was diagnosed with bell's palsy on 23May2021 09:00 which resulted in emergency room visit. Unspecified medication for 7 days was given as treatment. Outcome of the event was unknown. The patient was skeptical in taking the 2nd dose and her physician stated to postpone it. She was asking if she should take the 2nd dose. Patient was not diagnosed with covid prior to vaccination and has not been tested post vaccination. Information on Lot/Batch number has been requested.
51 2021-06-09 burning sensation since I have gotten the covid-19 vaccine I have been breaking out into hive and rashes and they itch... Read more
since I have gotten the covid-19 vaccine I have been breaking out into hive and rashes and they itch and burn lines on my body that are raised. I have red spots inside my hands on a daily basis. hands itch. get them on my legs knees and below.
51 2021-06-09 facial pain, numbness Right side of face cheekbone area swelled (NO fillers!!), went numb to the touch but deeply painful... Read more
Right side of face cheekbone area swelled (NO fillers!!), went numb to the touch but deeply painful for the next 5/6 days
51 2021-06-09 numbness Developed chest pain and numbness on the left side of the body. She explained it felt like lidocain... Read more
Developed chest pain and numbness on the left side of the body. She explained it felt like lidocaine was injected all over the left side of her body. The symptoms resolved on Wednesday, May 19th when she was receiving testing for her condition.
51 2021-06-09 muscle spasms In the weeks following my second dose, my legs and feet cramp daily. At times my feet are in a const... Read more
In the weeks following my second dose, my legs and feet cramp daily. At times my feet are in a constant battle to NOT be in a cramp. The cramps move up my calves and cause extreme amounts of pain. I have been hydrating up to a gallon of water a day and that does not stop the cramps. I have started taking magnesium and all other vitamins to help but nothing has helped so far.
51 2021-06-09 pain in extremity A sore arm but no other issues so far; This is a spontaneous report received from a contactable othe... Read more
A sore arm but no other issues so far; This is a spontaneous report received from a contactable other-HCP and a contactable consumer. A 51-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 05Apr2021 at single dose for COVID-19 immunisation. Relevant medical history was not reported. Concomitant medications included palbociclib (IBRANCE) taken orally from Dec2020 at 75mg daily 21 days on, 7 off for breast cancer. The patient was doing well on palbociclib, saw MD the day before and had labs. All were good so she was able to get COVID vaccine, had a sore arm in Apr2021 but no other issues so far. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-06-10 mild one side paralysis, tingling Approximately 4 days after my 2nd vaccine shot, I began to have mild paresthesias and subtle leg wea... Read more
Approximately 4 days after my 2nd vaccine shot, I began to have mild paresthesias and subtle leg weakness. I have been to a neurologist, who has done extensive testing. He has diagnosed me with small fiber neuropathy which has been slowly progressing since it's onset. I have had negative MRI's, EMG's, and huge amount of tests looking for autoimmune and labs for paraneoplastic were all negative. My fatigue an weakness is affecting my work and lifestyle now. I am 52 and very fit and active woman who golfs and exercises regularly. I have no family history nor any other medical reason to explain my symptoms except temporally appears to have started with the vaccine. There have been case reports of similar neurological things occurring. Steroids did not help.
51 2021-06-10 numbness Patient states that she is having numbness to face. Feels like tongue is swollen. Reports stiffnes... Read more
Patient states that she is having numbness to face. Feels like tongue is swollen. Reports stiffness to neck. Patient instructed to massage area. Patient reports symptoms no longer persist.
51 2021-06-10 tingling dry mouth; tongue felt lazy; trouble swallowing; light headed/Felt faint; Starting tingling; itching... Read more
dry mouth; tongue felt lazy; trouble swallowing; light headed/Felt faint; Starting tingling; itching; Face broke out with a rash; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER, formulation: solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:15 (at the age of 51-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, hypertension, pituitary tumour benign, drug hypersensitivity and food allergy from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. The patient did not have covid prior vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021, the patient experienced dry mouth and tongue felt lazy for 8-10 minutes, lightheaded/felt faint for 10-12 minutes, itching for 30 minutes, trouble swallowing, tingling and face broke out with a rash. Therapeutic measures were taken as a result of the events. The patient was treated with Benadryl for these allergic reactions. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
51 2021-06-12 pain in extremity Pt reports she had a sore arm for a month and was unable to raise her arm during that time. Symptom... Read more
Pt reports she had a sore arm for a month and was unable to raise her arm during that time. Symptom self resolved
51 2021-06-13 feeling hot PATIENT FELT LIGHTHEADED AND WARM. PATIENT LAYED DOWN AND SYMPTOMS RESOLVED
51 2021-06-13 numbness, facial pain, trigeminal neuralgia, nerve pain, pain in extremity, tingling I was fine until the following day felt some tingling in my fingertips and feet. Then the day after ... Read more
I was fine until the following day felt some tingling in my fingertips and feet. Then the day after that, my face has some tingling. By Monday, the left side of my face was feeling numb when I went to work and as the week went on the tingling became worse and became more painful. The pain went from my jaw up the left side of my face, pain across and was traveling up my head pass my temple (up to my forehead). I was diagnosed at the hospital with Trigeminal Neuralgia. I started to get shooting pain across my back (happened the second week just out of nowhere and I'm the type of person that waits to see what would happen and then it slowly, after a few weeks, went to the lower right side of my back. So, I thought it was from the way I was sleeping and then on June 3rd, I went to my Doctor because the pain had started to radiate down the front/back of my leg and my hip on the right side of my body (leg and hip); therefore, I went to my PCP. He gave me what he though (complete physical) his clinical diagnosis was since I had nerve trouble (possibly related to nerve inflammation and he wanted to see because it was not a disc or anything else...nerves have become inflamed). He give me a steroid shot and give me oral steroids and if after I took them that if I didn't feel the pain anymore in my nerves it was because my nerves became inflamed. The pain has gone away and I am keeping my fingers crossed that it does not happen again. My Doctor and I do believe that before COVID came out that I was very ill and I had all the COVID symptoms. I went and at that time there was no testing available. The Doctor basically tested me and feels that I may have had COVID since he tested me for Strep Throat the last week of February 2020.
51 2021-06-13 pain in extremity Left arm, back, chest pain, heart palpitations starting on Friday, June 4th. ED visit and testing s... Read more
Left arm, back, chest pain, heart palpitations starting on Friday, June 4th. ED visit and testing showed normal EKG, labs. Discharged home. Returned to ER on Sunday, June 6th. EKG showed ST elevation. Transferred to ED. Positive troponin, admitted to hospital with suspected perimyocardits with intent to rule out heart attack.
51 2021-06-13 pain in extremity The day after the second vaccine I got bodyaches and a headache. The next day I had pain in my hands... Read more
The day after the second vaccine I got bodyaches and a headache. The next day I had pain in my hands and feet and they felt like they were swollen, but I had no swelling. Over the next week the sensation of swelling continued in my hands and feet and I have severe joint pain and mild swelling in my lower extremities. I have not felt well since.
51 2021-06-13 cold extremities, speech disorder, tingling, feeling hot Immediate and continuing reaction within five minutes of shop. Felt warm and tingling from knees to... Read more
Immediate and continuing reaction within five minutes of shop. Felt warm and tingling from knees to feet and hands, light headed, heavy chest, knot in throat, blood pressure and pulse elevated. Blood pressure rose to 169/114. no previous issues of high blood pressure. I have continued to have many issues, my whole body is having multiple issues. Hard to breathe, walk, talk, pains in head and body, coughing, chills, freezing hands and feet.
51 2021-06-14 weakness, pain in extremity First dose January 6 2021, only pain in the arm. Second dose January 28, 2021, day after the shot,... Read more
First dose January 6 2021, only pain in the arm. Second dose January 28, 2021, day after the shot, had to leave work, chills, nausea, extreme weakness, joint pain, muscle pain. By the end of the day and continuing into the next two days, joint and muscle pain, hard painful swollen lymph nodes in armpits, neck, collarbone area, behind knees, inguinal area. Couch bound for 3 solid days. Swollen nodes lasted approx 1 week. Weakness persisted into week #2, about 10 days. Weight loss. Random bloodwork drawn for a physical on February 20, 2021 - fasting blood glucose was 407. Last two blood glucose levels, 2017 and 2019 were both 108. March 6, 2021 fasting glucose 347, HgbA1C 13.8%. March 15, 2021 fasting blood glucose 240, HgbA1C 10%. Joint pain persists. Started on Metformin 500mg po bid March 18, 2021. BGMs range from 475+ to 361 until March 30, 2021. April BGMs range 326-coming down to 209 and 198. Metformin increased May 24, 2021 to 1000mg po bid. bgms starting May 24, 2021 at 156, have come down to high 120s. Weight December 8, 2020 was 198. Weight loss of around 30 lbs, weight currently today 174.
51 2021-06-14 numbness Developed left sided numbness involving entire body 10-11 days after first Pfizer vaccine. This is ... Read more
Developed left sided numbness involving entire body 10-11 days after first Pfizer vaccine. This is persistent and has not improved since.
51 2021-06-14 tingling, numbness extreme malaise and headache within 24 hrs of taking 2nd dose. Patient reports numbness and tinglin... Read more
extreme malaise and headache within 24 hrs of taking 2nd dose. Patient reports numbness and tingling in hands and feet.
51 2021-06-15 migraine I had 4-5 hours of dizziness and tachycardia. I have brief dizzy spells. Having more intense and fre... Read more
I had 4-5 hours of dizziness and tachycardia. I have brief dizzy spells. Having more intense and frequent migraines.
51 2021-06-15 pain in extremity sore arm; tired; headache; nausea; This is a spontaneous report from a contactable consumer (patient... Read more
sore arm; tired; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:45 at the age of 51-years-old (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation. The patient was not pregnant. No Covid prior vaccination. The patient had not tested for Covid post vaccination. Medical history included bicuspid aortic valve, thyroidectomy, seasonal allergy. The patient concomitant medications were not reported. The patient experienced sore arm, tired, headache, nausea all on 10Mar2021 14:00 with outcome of recovering. The patient did not receive any treatment for the events. The events were assessed as non-serious. No follow-up attempts are possible. No further information is expected.
51 2021-06-16 flushing hives; face flushed; allergic to vaccine; This is a spontaneous report from a contactable consumer (... Read more
hives; face flushed; allergic to vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8730), via an unspecified route of administration, administered in the left arm on 01Apr2021, at 09:30 (at the age of 51 years old) as first dose, single dose for COVID-19 immunisation. The patient has an allergy to muscles. However, it was also reported that patient had no medical history, family history, and concomitant medications. The patient had no other vaccines four weeks prior vaccination. On 01Apr2021, the patient experienced hives and face flushed that developed within 5 minutes after vaccination. She said it could have been sooner than 5 minutes but that was when she pushed her sleeves up and the hives were there when she did that. The patient also reported that her face flushed and all of it went away in minutes. The patient went to see an allergist and got an allergy test and it showed that she is allergic to the vaccine and they told her she could get the second dose, but they would be there with epinephrine (reported as Epi). It was reported that the allergist put fresh eye drops under her skin and told that she was allergic to the vaccine itself and PEG and polysorbate. The patient further stated that they did not provide her with a preservative name, the physician just said she was allergic to the preservative. The patient said she is not going to do the second one, but she is trying to find out if the company is going to come out something without the preservative because that was what they told her she was allergic to. The patient underwent lab tests and procedures which included allergy test: allergy to BNT162B2, PEG, and polysorbate on an unspecified date. The patient did not receive treatment in response to the events. The patient said that they were busy, so she did not tell anyone and just sat down for her waiting time; the events faded away while she was sitting. The patient recovered from the events on 01Apr2021. No follow-up attempts are needed. No further information is expected.
51 2021-06-16 flushing Metallic smell/taste; Metallic smell; Elevated heartrate; Flushed; Tiredness; This is a spontaneous ... Read more
Metallic smell/taste; Metallic smell; Elevated heartrate; Flushed; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration at left arm on 16Mar2021 at 13:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hypertension, ADHD , anxiety/depression and also had allergy to contrast dye. Concomitant medications included losartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient didn't receive any other vaccine within 4 weeks prior to COVID-19 vaccine. On 16Mar2021 at 13:30, the patient experienced metallic smell, metallic taste, elevated heart rate, flushed and tiredness. No therapeutic measures were taken for the events. The clinical outcome of metallic smell, metallic taste, elevated heart rate, flushed and tiredness was resolved on an unknown date at the time of this report. No follow-up attempts are needed. No further information is expected.
51 2021-06-16 nerve pain Nerve pain running from fingers up through shoulder to base of neck after injection. Pain was really... Read more
Nerve pain running from fingers up through shoulder to base of neck after injection. Pain was really bad for at least a week. I still have residual pain in my hands and forearm from the shot.
51 2021-06-16 pain in extremity This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female pat... Read more
This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7534, Expiration Date- 31Jul2021) via an unspecified route of administration in left arm on 23Mar2021 11:15 as 1st dose, single dose (at the age of 51-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8729, Expiration Date- 31 Jul 2021) via an unspecified route of administration in left arm on 13Apr2021 11:15 as 2nd dose, single dose for COVID-19 immunization. Vaccine was not administered at Military Facility. Patient did not receive any prior vaccinations within 4 weeks. Patient medical history included that she was over-weight. The concomitant medications were not reported. Patient is the only girl in the house and she noticed after her first dose she skipped her period that month (Apr2021), her period did not come, which does not happen to her. Patient added her period is every 26 days pretty reliably. She had a period 09Feb2021 and 06Mar2021 and she did not have period again until 29Apr2021 which was 28 days later. She skipped it sometime in early April, clarifies she should have had her period on 01Apr2021. After 29Apr2021 she got it 16 days later and now she is waiting for her next period. She did not know if her next period would be normal or not. She did not know if her body was readjusting. She did not think anything of it until she started hearing things here and there about vaccines affecting periods and vaccine shedding. On 23Mar2021, patient experienced soreness in her arm which was hurting. On 24Mar2021, she was also very tired and had joint aches/body aches. Around 11 days after first vaccine (on 03Apr2021) she had stomach issues, like diarrhea for 4 days or something. She did not eat anything weird or unusual. No one else had it so it could not be a virus. She mentioned it to them and asked could it be a side effect of the vaccine and they said sure, it could be. The adverse events did not result in the emergency room visit of physician office visit. The outcome of the event skipped period was unknown, of the event stomach issues/diarrhea was resolved on 07Apr2021, while for other events was resolved on an unspecified date in Mar 2021 (reported as 25Mar2021 or 26Mar2021). No follow-up attempts possible. No further information expected.
51 2021-06-16 pain in extremity Mild pain in left arm; This is a spontaneous report from a non-contactable consumer or other non hcp... Read more
Mild pain in left arm; This is a spontaneous report from a non-contactable consumer or other non hcp. This consumer (patient) reported for herself that 51-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Left on 07Jun2021 as unknown, single dose for covid-19 immunisation. Medical history included pain in lower abdomen and diarrhoea during the time of infection. The patient's concomitant medications were not reported. The patient previously took xeljanz XR (11MG). The patient reported mild pain in left arm after receiving COVID vaccine yesterday (07Jun2021). The patient underwent lab tests and procedures which included colonoscopy: bcteria in her colon on Mar2021 (she was on antibiotics for bacteria in her colon found after a colonoscopy). The clinical outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
51 2021-06-16 speech disorder, weakness, numbness Heart since beating really very fast; I can't even walk; Feel really drunk; Also numbness I guess my... Read more
Heart since beating really very fast; I can't even walk; Feel really drunk; Also numbness I guess my face; 'Swollen' face; Don't feel good; Dizzy; I am weak, if you look into my eyes I look I am really sick; I am tired; Headache; Sick; can not even speak; This is a spontaneous report received from a contactable consumer (Patient) or other non HCP. A 51-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0181, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 12Jun2021 11:00 (at the age of 51-years-old) as first dose single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On 12Jun2021, the patient experienced heart since beating really very fast, cannot even speak, feel really drunk, also numbness in face, swollen face, don't feel good, dizzy, weak, tired, headache, sick and can't even walk. Patient had some side effects from the shot today. Got the first dose this morning, since then her heart beating really very fast throughout the day, she actually felt really drunk, she cannot even speak to you, cannot even walk, she was out of it. Consumer stated, that was not worrying, she did not feel good, she did not really feel very good (voice not clear). She was tired, had a headache, her face was like either swollen or numb, she was dizzy, she was weak, she told that if someone look into her eyes, she looked like she was really sick, she can hardly even walk, felt like she drunk. The patient underwent lab tests and procedures which included heart rate: fast on 12Jun2021.The outcome of events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
51 2021-06-16 tremor, tingling Patient became dizzy and shaky within 7 minutes after getting first dose. She stated her hands were ... Read more
Patient became dizzy and shaky within 7 minutes after getting first dose. She stated her hands were tingly and that she felt like she would pass out. The paramedics were immediately called. Paramedics took about 15 minutes to arrive and they attended to the patient. Patient was believed to have a panic attack but they recommended patient to see a md just in case its something different. Patient was able to walk out the store fine after about 40 minutes after the paramedics arrived and helped her out.
51 2021-06-17 electric shock sensation, tremor, pain in extremity, muscle spasms, feeling cold The week before I had the second shot - I got a very strange sharp pain in the middle of the chest a... Read more
The week before I had the second shot - I got a very strange sharp pain in the middle of the chest and it didn't go away. Went to the back of my neck. My boss told me to go to ER. The pain in my chest left me with a very heavy headache. I didn't have any anxiety or anything. Got the second vaccine a week later, fine all the day long after it. Early in (03:00 am) morning of the next day, I started feeling massively achy. Every part of my body ached. It felt like electrical sensations coming from my shoulders down into my arms and down to hands (and into my hands). It was happening in my legs - the pain was in my legs and into my feet yet the electrical feeling was in the tip of my toes. It was very weird. I started thinking I should get up and walk around even though I didn't feel good. I kept walking around to get the sensation to go away. It didn't go away. It felt like I was getting cramps in my legs then and this was intense how sick I got - I got the chills - freezing cold. My teeth were chattering - the inside of my organs were shaking and freezing cold. When I got up the next morning, I had a fever 101. 5 and face was red. Those sensations lasted for an entire day and they started to go away but then I had a massive headache. Could hardly lift my head. Tylenol wouldn't work. I tried Ibuprofen later and that didn't work. I just felt overall like I'd been hit by a truck with major headache and pressure behind my eyes. I had no issues seeing at all but my son and his friend were with me and they told me something was wrong with my eye. They said that it looked like my pupil was a funny shape (my left eye). When I looked around, it felt like that my eye was tugging (my eyeball).I called the eye doctor and he got me in immediately. Eye doctor couldn't find anything technically wrong with my eye - pressure and tugging sensation lasted a couple of days more along with the headache.
51 2021-06-17 muscle spasms, hot flush, tingling, hypersensitivity of all senses, numbness Within 15 minutes after shot, painful band around chest (bra line) on L side (lasted 2 hours), warm ... Read more
Within 15 minutes after shot, painful band around chest (bra line) on L side (lasted 2 hours), warm flush through upper body and dizzy (10 seconds) and pins and needles and numb in left arm down to fingers (as of today, has not disappeared). General feeling of achy first week. Occassionally bad headaches that last 2 days in the first 2 weeks. On 11th day after shot got tingly and numb and over sensitive (feels like sunburn) on left side of face and body that continues still today. This also afffects my tongue and roof of mouth, my jaw line and my teeth. I did see a destist in case I had an infection. He found nothing. Also on 11th day tingly and numbness down left leg that has continued even now. I have had a charlie horse in my L calf and my muscles tense up in my bicep and calf often. Nausea during the second week after shot.
51 2021-06-18 night sweats Pain radiating to my back; Night sweats; Severely swollen Lymph Nodes with pain radiating to my back... Read more
Pain radiating to my back; Night sweats; Severely swollen Lymph Nodes with pain radiating to my back.; Severe chills; probably fever; This is a spontaneous report from a contactable patient. A 51-year-old non- pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN), via an unspecified route of administration on left arm on an unknown date in Mar2021 at 12:30 (at the age of 51-years-old), as single dose for COVID-19 immunisation. Medical history included high cholesterol and anxiety started on an unknown date. The patient's known allergy to sulfa meds and hazel nuts. Concomitant medications included Montelukast Sodium (SINGULAIR), Sertraline (ZOLOFT), Levothyroxine (MANUFACTURER UNKNOWN), Lovastatin (MANUFACTURER UNKNOWN); all for unknown indication, from unknown dates and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 17Mar2021 at 10:00, the patient experienced severely swollen lymph nodes with pain radiating to the back. The patient also experienced severe chills and night sweats (probably a fever but didn't take temp). The patient did not receive any treatments for the events. The clinical outcome of the events severely swollen lymph nodes with pain radiating to the back, severe chills, night sweats, probably fever was recovering at the time of reporting. Information about lot number cannot be obtained. No further information is expected.
51 2021-06-18 tingling Inflammatory immune response; Vasculitis; Suffering paresthesia since 2 days after my 1st dose of CO... Read more
Inflammatory immune response; Vasculitis; Suffering paresthesia since 2 days after my 1st dose of COVID-19 vaccine.; Small fiber neuropathy; This is a spontaneous report received from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 administered in Arm Left on 25May2021 (Lot Number: EW0183) at age of 51-year-old as 1ST DOSE,SINGLE for covid-19 immunisation. Medical history included known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination was fexofenadine. The patient suffering paresthesia since 2 days after her 1st dose of COVID-19 vaccine -now on day 12. A neurologist has diagnosed her with an inflammatory immune response causing small fiber neuropathy and possible vasculitis. Events onset date was 26May2021. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received. The outcome was Not recovered. No COVID prior vaccination. No COVID tested post vaccination.
51 2021-06-21 involuntary muscle movements, electric shock sensation, muscle twitching I was experiencing serve pain , electrical shocks , twithcing and jerks throughout my body. My docto... Read more
I was experiencing serve pain , electrical shocks , twithcing and jerks throughout my body. My doctor recommended taking Advil and it was a stabbing shock in my ankle hooked up to a batter. The sensation lasted for 7hrs I went to the ER. I can not walk far distances without my joints or nerves being aggravated.
51 2021-06-21 flushing, feeling hot, difficulty speaking Patient experienced an adverse reaction with her first dose of the Pfizer vaccine at our vaccine sit... Read more
Patient experienced an adverse reaction with her first dose of the Pfizer vaccine at our vaccine site. In order to prevent another episode happening, we administered the vaccine in our secluded first aid room so that she could be closely observed. Vaccine administered at 3:45 pm, first symptom of flushing and feeling warm began at 3:51 pm. Benadryl 25 mg PO was administered at 3:51 pm. At around 3:53 pm patient reported swelling of her throat. Patient appeared tachypneic, VS assessment completed. BP 128/76 P 69 RR 19 O2 99% RA T 98.3. EMS called at 3:53 pm, paramedics arrived on site at 4:00 pm. Paramedics advised patient to go to hospital for further evaluation, patient refused and remained at our site for further observation for 45 minutes. Symptoms at time of adverse reaction include, swelling of throat, flushing, sweaty, shortness of breath, sensation of throat closing, itchiness in throat, wheezing noted upon auscultation and change in voice. Applied ice packs and encouraged fluid intake. Patient stated she felt better, was able to communicate all needs and ambulate independently.
51 2021-06-21 numbness, tingling, weakness Right side facial numbness, right wrist & ankle numbness and tingling and weak.
51 2021-06-21 pain in extremity, weakness heart "attack" episode; pain into my jaw and down my arm; pain into my jaw and down my arm; couldn't... Read more
heart "attack" episode; pain into my jaw and down my arm; pain into my jaw and down my arm; couldn't breath /Shortness of breath; muscle pain; weakness; inflammation; high BP; muscle weakness; pain; This is a spontaneous report form a contactable consumer reporting for herself. A 51-year-old (Non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot Number: unknown) via unspecified route of administration in right arm on 31Mar2021 13:00 (at age of 51-years old) as single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. Patient had no other allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. Patient received other medications in two weeks Birth Control. Patient had reported that, had her first shot on Wednesday, 31Mar2021. By Thursday, 1Apr2021 09:30 AM she was experiencing muscle weakness and pain. Tuesday morning at 5:30 am 6Apr2021 she woke up experiencing what now known to have been a heart attack episode. She felt like abs elephant was sitting on her chest while left side she had pain into her jaw and down her arm as well as could not breath. Shortness of breath. This lasted 15-20 min. She has since for the past 2 months been in and out of doctors trying to figure out the source of her muscle pain and weakness. The Adverse events resulted in visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability, or permanent damage. She went from only seeing her doctor every couple of years only when not well to she has now seen a cardiologist, rheumatologist, orthopedic. She has had EKGs, Computed tomography (CT) Scan of her heart, stress test, been put on BP meds, anti-inflammatory, antidepressants. To try and regulate her inflammation and to help keep the inflammation from causing stress on her heart aka. high BP. She went from a healthy active self-employed 51-year-old woman to her body literally giving out since shot. Treatment received for adverse events through Medication. Patient underwent lab test and procedure include Electrocardiogram, CT Scan of her heart, stress test on unspecified date result was unknown. The outcome of all events recovered with sequel (Recovered with lasting effects). Information on batch/Lot number has been requested.
51 2021-06-21 tingling, pain in extremity Onset w/ myalgias, back pain and severe headache. Next day with swelling and shooting pain in Righ... Read more
Onset w/ myalgias, back pain and severe headache. Next day with swelling and shooting pain in Right arm (Injection was given in Left arm) Shooting pains in bilateral thighs. Migrating polyarthralgia, bilateral hand tingling. Debilitating pain and fatigue that is interfering with activities of daily living including employment
51 2021-06-22 discomfort I am having swelling and discomfort on left side of my body since getting the Pfizer vaccine.
51 2021-06-22 feeling hot, pain in extremity SARS-COV-2; drug ineffective; Hurt to pick it up; Redness and heat; Swelling in the arm with a littl... Read more
SARS-COV-2; drug ineffective; Hurt to pick it up; Redness and heat; Swelling in the arm with a little knot; lost appetite; sick; itching off the arm/Itchy and wanted to scratch it/Really Itchy; arm pain/Arm got really sore; arms getting stiff and could barely move it/it got stiff; arm swelled up like a baseball and was really itchy and hot to the touch; arm swelled up like a baseball and was really itchy and hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 18May2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included immune system disorder. Patient was a kidney transplant recipient, being an immunocompromised patient would be a contraindication in getting the second dose of the vaccine. There were no concomitant medications. On 28May2021, the patient experienced itching off the arm and wanted to scratch it, arm pain got really sore, arms getting stiff and could barely move, pain, arm swelled up like a baseball and was really itchy and hot to the touch, redness and swelling in the arm with a little knot or mass, sickness and loss of appetite.The patient underwent SARS-COV-2 test which was positive on an unspecified date in the past. As the patient was immunocompromised wanted to know whether she could take the second dose. No follow-up attempts are possible. No further information is expected.
51 2021-06-22 cold extremities, tingling, burning sensation Intermittent increased heart rate and blood pressure.; intermittent increased heart rate and blood p... Read more
Intermittent increased heart rate and blood pressure.; intermittent increased heart rate and blood pressure.; tingling in her hands and from knees to feet.; sometimes cold and tingling in hands and from knees down to her feet; heaviness in chest; she has heat and burning; This is spontaneous report from a contactable consumer (patient). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17May2021 (Batch/Lot Number: EW0183) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation. Medical history included ongoing corneal erosion (diagnosed about 20 years ago), ongoing sleep apnoea syndrome (diagnosed about a year ago). Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient got the first dose of the Pfizer Covid vaccine on 17May2021 and within 5 minutes her hear rate (HR) and blood pressure were really high, stated her blood pressure was like 169/114 at the time or something like that. The patient also felt some weight on her chest, sometimes cold tingling in her hands and from knees to feet and heat and burning, all on 17May2021. The patient had no issues prior to the vaccine. The patient stated that over the last three weeks she has been to urgent care, her doctor's office, and even had an ambulance take her to the ER for high blood pressure and heart rate, stated she just keeps having episodes. The patient is now waiting on her cardiologist, stated they did tests at hospital yesterday, has had some EKGs and blood tests, no exact information known, states sent her home and had another episode not as bad. Doctor has not seen this type of reaction, wondering what is going on with this kind of reaction. They treated her high blood pressure with two different medications: carvedilol and tried a different one as well, metoprolol. The patient underwent lab tests and procedures which included blood pressure measurement 169/114 on 17May2021 within 5 minutes her HR and BP were really high, blood test unknown results on 17May2021, electrocardiogram unknown results on 17May2021, heart rate really high on 17May2021. The patient was not recovered from the events blood pressure high, tingling feet/hands, cold hands & feet, chest heaviness while outcome of the other events was unknown.
51 2021-06-23 weakness DIZZINESS, NAUSEA, WEAKNESS
51 2021-06-23 face paralysis, bell's palsy, slurring Bells Palsy left side of face. Symptoms started on Saturday June 5, 2021 in the morning. Symptoms in... Read more
Bells Palsy left side of face. Symptoms started on Saturday June 5, 2021 in the morning. Symptoms included but not limited. Tingling of tongue and then loss of taste, pain in left jaw, pain in left ear, muscle weakness left side of face (unable to fully close left eye, unable to raise left eyebrow, left nostril unable to flare, slurring of speech, unable to fully smile, stuttering while speaking) worsening of vision in left eye.
51 2021-06-23 pain in extremity, numbness After getting my 1st dose of the Pfizer COVID shot, the very next morning, i noticed i could no long... Read more
After getting my 1st dose of the Pfizer COVID shot, the very next morning, i noticed i could no longer bend my ring finger on my right hand. I have had some "arthritis like symptoms" in my hands since about last summer 2020, and they seemed like they were getting somewhat better, but since getting the Pfizer first dose, those symptoms have gotten worse (like sometimes either of my hands fall asleep for no reason; pain in my hands; very stiff and cannot bend them to make a fist; other wierd feelings or symptoms in my hands). In addition, i have not been able to bend the ring finger on my right hand anymore since the first dose on 4/11/2021. This is completely new and the symptoms i have described have not gotten better since the first dose. I was hoping this would all get better but since it has now been over 2 months, i thought i should report it. i got the 2nd Pfizer shot on 5/1/2021. Thank you
51 2021-06-23 pain in extremity Back of heel on left leg hurting the same night as of shot, next morning it was very painful. Never ... Read more
Back of heel on left leg hurting the same night as of shot, next morning it was very painful. Never had any pain let that.
51 2021-06-24 weakness Daily Headaches, Felt like tight knot in epigastric area, weakness, high blood pressure, heart palpi... Read more
Daily Headaches, Felt like tight knot in epigastric area, weakness, high blood pressure, heart palpitations, high heart rate, overcome by feeling like was going to die(only in the first 3 weeks), lost 8 pounds in 2 weeks, feeling of heavy arms and legs, sensitive to caffeine and sugar First month was the worst and slowly started feeling some better. Still have headaches, blood pressure problems, palpitations, uncomfortable feeling in epigastric region and sometimes feels tight there like its being squeezed, dont have much stamina, cant exercise (was a runner)
51 2021-06-24 numbness, paralysis Numbing from head down to whole body, throwing up, could not walk, paralysis. Spouse had to take her... Read more
Numbing from head down to whole body, throwing up, could not walk, paralysis. Spouse had to take her to ER. She was treated with fluids, Mg, antibiotics. She was diagnosed with bladder infection .Later developed blister in the mouth
51 2021-06-24 pain in extremity I have small fiber neuropathy; I have other symptoms; it hurt really bad and I told him to take it o... Read more
I have small fiber neuropathy; I have other symptoms; it hurt really bad and I told him to take it out of my arm and he did, but I believe he hit a nerve or something in my arm; Pain in the ears; Headache; Pain you know the fire in my feet and my legs; Heart beats fast; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 51-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration and administered in left arm on 05Apr2021 (at the age of 51-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient took the Pfizer vaccine (COVID Vaccine) on 05Apr2021 and she went to the emergency room not long after that and then she went to ask a doctor not long after that and just went to a neurologist. She told that she had small fiber neuropathy (on an unspecified date in Apr2021) and called the Pharmacist at pharmacy where she had the vaccine and told them what had happened. When the man gave her the vaccine it hurt really bad (on an unspecified date in Apr2021). The patient told him to take it out of her arm and he did, but she believed he hit a nerve or something in her arm, pain in the ears, headache, pain you know the fire in her feet and legs, heart beats fast, shot in her left arm, it hurt really bad (on an unspecified date in Apr2021). The patient stated the patient did not take the second vaccine because of this problem. She did not have any of these problems until and after she took the vaccine, whole day 'without any side' effects. The patient was taking medication, Gabapentin (treatment). She had to go back in two weeks. She did not know why all this was happening. The patient was fine until she took the vaccine. The patient underwent lab tests and procedures which included she took 5 or 6 vials of blood when reporter was there on Thursday, not sure what all she was testing with unknown result. Was in the hospital (further clarification unknown) in April they did do a CBC, Differential Metabolic Panel, Urinalysis, Drug screen, EKG, Chest x-ray. They did all sort of stuff. When reporter went to the (voice not clear) doctor they did an ultrasound on her legs and said that her veins were okay and then the neurologist said that the nerves (incomplete sentence). Therapeutic measures were taken as a result of events with gabapentin take 100 mg three times a day for a week and then (voice not clear) it up to more than that for the second week and more than that for the third week (further not clarified). The outcome of events was unknown. Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021744526 similar report from same reporter
51 2021-06-24 tremor, muscle spasms On June 11, 2021 I had to get a CT scan of my abdomen. After I was given contrast via IV through my... Read more
On June 11, 2021 I had to get a CT scan of my abdomen. After I was given contrast via IV through my right arm I started having tremors in my left hand and left foot. Tremors in my hand resolved within one hour. Tremors in my foot lasted three days four days. Additionally my foot felt like it was cramping. This incident occurred after my first vaccination. I am reporting this as this unusual event is possibly related.
51 2021-06-25 discomfort Ever since the next day from receiving the vaccine I've been feeling dizziness and extreme uncomfort... Read more
Ever since the next day from receiving the vaccine I've been feeling dizziness and extreme uncomfortable feeling of disequilibrium as if confused as to where I find myself in space. It's not quite vertigo but like nothing I've ever had. I feel as if I will collapse or fall and unstable in terms of my surroundings/space around me. It's an odd feeling I never have and debilitating. In addition, I feel it's hard for me to get up in the mornings, there is a lingering tiredness that will not go away as if I have a foggy and heavy brain. Sense of heaviness in my entire body and specially my legs and discomfort or pressure in the back of my head. I simply do not feel the same at all as prior to being vaccinated.
51 2021-06-25 feeling hot Patient got overheated, lightheaded, dry heaving. EVerything started about 10 minutes after injecti... Read more
Patient got overheated, lightheaded, dry heaving. EVerything started about 10 minutes after injection. Patient ended going with EMS to hospital upon her request.
51 2021-06-25 nerve pain, pain in extremity Left arm nerve pain on top of fore arm and down to the knuckles of left hand. Relatively mild, nuisa... Read more
Left arm nerve pain on top of fore arm and down to the knuckles of left hand. Relatively mild, nuisance level, pain that sometimes goes away but is there most of the time. Now two and a half months after the shot, I wonder if this is a permanent condition. FYI - I had my second Shingles shot on February 4th, 2021 and had one day of fever, chills, head ache, and nerve pain which went away after 48 hours or so.
51 2021-06-28 numbness Systemic: pt indicated that has numbness in fingers/hand/arm-Medium
51 2021-06-28 migraine, cold sweat I woke up at 6am the morning after receiving the vaccination. I was awake for about 2 and a half hou... Read more
I woke up at 6am the morning after receiving the vaccination. I was awake for about 2 and a half hours when I began feeling exhausted, nauseated, had an intense headache and cold chills. I went back to bed at 8:30am. I covered myself with 2 quilts and my bathrobe due to chills. I had cold sweats, a fever, nausea, diarrhea, body pain, a migraine, lucid dreams, and hallucinations for the next 36 hours. At around 36 hours I still had a migraine, muscle and body pain, the other symptoms had waned. My last three symptoms lasted for about 4 days and slowly lessened over time.
51 2021-06-28 tingling, numbness, pain in extremity 24 hours After receiving this vaccine I thought I just had a sore arm & tiredness. The first week I... Read more
24 hours After receiving this vaccine I thought I just had a sore arm & tiredness. The first week I did feet just tiredness but then the second week tiredness became fatigue & I required naps after work and sleeping all night, Headaches ,Chills, Achy. Herpes breakouts are now occurring monthly,. CREST symptoms are worse, I feel exhausted most of the time, several times each hour I have Loss of circulation in hands, feet & gut. This is Painful & causes numbness,tingling,heaviness in my arms & legs.
51 2021-06-29 pain in extremity dizziness; sore arm; mild cold with ear infection; mild cold with ear infection; This is a spontaneo... Read more
dizziness; sore arm; mild cold with ear infection; mild cold with ear infection; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in in arm left on 20Jan2021 at 13:00 (at the age of 51-year-old) as single for COVID-19 immunization. Vaccine facility type was Hospital facility. The patient did not had medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not administered other vaccine in four weeks or other medications in two weeks. Prior to vaccination, the patient did not had COVID. The patient was healthy. On 20Jan2021, the patient experienced sore arm immediately and on 25Jan2021, about 5 days later, she experienced dizziness. After 2 days of dizziness and not going away, it scared her enough to think she might have COVID. On 28Jan2021, the patient underwent lab test and procedure which included nasal swab: negative. Dizziness tapered off and lasted approximately 6 days. Assumed it was a possible mild cold with ear infection. Therapeutic measures were not taken as a result of the events. The outcome of all the events was unknown. Follow-up attempts completed. No further information expected.
51 2021-06-30 pain in extremity Body ache like all over.; Headache; Left arm is swollen.; She got the rash.; Injection site is swoll... Read more
Body ache like all over.; Headache; Left arm is swollen.; She got the rash.; Injection site is swollen.; I started feeling really tired I mean so tired that I couldn't stay awake though I slept for several hours and then I woke up.; My arm was started to getting sore the first day a little bit but the next day which is yesterday was really-really bad.; I couldn't move my arm.; My neck is pretty bad and it's real bad. It's just got pretty much shit.; sick with the flu; sick with the flu; could barely even walk or walk up the stairs; cough; This is a spontaneous report from a Pfizer. A contactable consumer (patient) reported that a 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0185, NDC number, UPC number, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm, upper arm close to my shoulder on 16Jun2021 (at the age of 51 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included bipolar, fibromyalgia and osteoarthritis in hand; all were from an unknown date and unknown if ongoing verbatim. Concomitant medications included alprazolam (XANAX), quetiapine fumarate (SEROQUEL), oxycodone taken for fibromyalgia and tizanidine taken for muscle relaxant therapy, start and stop date were not reported. The patient received first dose of BNT162B2 (Lot no: EW0168) administered in left arm, upper arm close to my shoulder on 26May2021 for covid-19 immunisation. Consumer stated as no prior vaccination (within 4 weeks). The report received as, the patient stated as, I don't think it says on here but my last time the recent one when I got the shot is 2 O' clock that was my appointment time. The first one patient trying to think it could have been the same time as 2 or 3 O' clock. Route of administration was as in a shot. The patient states, she has an autoimmune disorder and several things wrong with her. The patient states, she received two doses of the Pfizer Covid-19 vaccine. She felt fine with the first dose, but with the second dose that the patient received on 16Jun2021, it took patient days to get better, and today is the first day she feels normal again. from 16Jun2021 to today 21Jun2021 she had a headache, body aches, all over like the patient was sick with the flu, could barely even walk or walk up the stairs, had a cough, and her left arm and hand had swollen up along with a little bit of rash where the shot was, and her injection site is swollen as well. The patient stated as, it was the same day it was like I got it up 2 O'clock I stay there for 15-20 minutes went home and then in couple of hours I started feeling really tired I mean so tired that I couldn't stay awake though the patient slept for several hours and then the patient woke up. The patient thinks her arm was started to get sore the first day a little bit but the next day which was yesterday was really- really bad. The patient had headache, body ache like all over, I couldn't move my arm what else. The patient neck was pretty bad and it's really bad. It's just got pretty much shit. The patient stated on treatment as, no medication for the rash, when I got my shot there is slight rash, I am keeping an eye on it to make sure it doesn't grow. Just I am taking Ibuprofen for the extra pain that I got. The patient stated, no, I need to go and to my doctor I am really tasked up for my physical and blood work. No investigation assessment reported. Outcome of the events was unknown. Additional information has been requested.
51 2021-07-01 feeling hot After 2nd shot- Covid arm- large red spot by injection spot. Hot to touch. A little itchy. Appeare... Read more
After 2nd shot- Covid arm- large red spot by injection spot. Hot to touch. A little itchy. Appeared 3 days after injection. First day after injection felt drunk- woozy- foggy. Today is first day of Covid arm. No treatment yet. After first shot - felt dizzy and waves of nausea off and on for 4 days.
51 2021-07-01 hot flush Within 30 minutes I experienced the worst hot flash ever, I had to go to the pharmacy to just make s... Read more
Within 30 minutes I experienced the worst hot flash ever, I had to go to the pharmacy to just make sure everything is okay. The same day I had diarrhea, fever, pain all over body.
51 2021-07-01 numbness, flushing Tingling in the back of my throat; tingling in the back of my throat and tongue; Slight numbness in ... Read more
Tingling in the back of my throat; tingling in the back of my throat and tongue; Slight numbness in the effective area; a flushed feeling; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP 6955), via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified medications for an unknown indication since unknown dates within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021, approximately 20 minutes after the vaccination, the patient experienced tingling in the back of her throat and tongue, a flushed feeling and slight numbness in the effective area. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events tingling in the back of her throat and tongue, a flushed feeling and slight numbness in the effective area. The clinical outcomes of the events tingling in the back of her throat, tingling tongue, a flushed feeling and slight numbness in the effective area were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
51 2021-07-01 numbness Increase in heart rate (160), both arms became numb, vomiting, loss of consciousness. Was transferre... Read more
Increase in heart rate (160), both arms became numb, vomiting, loss of consciousness. Was transferred to ER.
51 2021-07-01 muscle spasms Months now after getting the shot I am having severe calf/foot cramps. Sometimes both feet cramp at ... Read more
Months now after getting the shot I am having severe calf/foot cramps. Sometimes both feet cramp at the same time traveling up my calves. This started two weeks after having the second dose.
51 2021-07-01 tingling, migraine Pt began complaining of tingling and swelling of left face, neck and throat about 15 minutes of vacc... Read more
Pt began complaining of tingling and swelling of left face, neck and throat about 15 minutes of vaccine. VS: 156/ 89, HR 84, O2 sats 99% on RA. Paramedics called after IM Benadryl 50 mg given. She was transported by ambulance to the ER. Pt also c/o migraine and of not eating all day.
51 2021-07-02 feeling hot feels hot on cheek, anxiety. Evaluated by EMS-Cleared
51 2021-07-02 migraine About 10 minutes in I started itching at the sight, sore throat, muscle pain at the sight about 15 ... Read more
About 10 minutes in I started itching at the sight, sore throat, muscle pain at the sight about 15 minutes into shot fatigue set in, I had a headache, really bad like a migraine and I don't get migraines. i laid down and took Tylenol.
51 2021-07-02 muscle spasms, numbness, pain in extremity, discomfort non-stop pain that goes to left side, in underarm, arm, neck, shoulder, shoulder blade, muscle tendo... Read more
non-stop pain that goes to left side, in underarm, arm, neck, shoulder, shoulder blade, muscle tendons, ligaments. Feeling of lumps, stiffness, muscle tenderness and muscle spasms, muscle cramping, a type of pressure that makes my arm feel heavy. It has gotten better but still not completely gone, now (7/3/21), I'm feeling numbness in my left arm and hand. My second dose of the vaccine was originally due on 6/12/21, it got postponed to 7/3/21 due to illness but I did not go for it as I'm still not well. Not sure now of when I should get the 2nd dose as it's supposed to be in a certain amount of days after the 1st dose.
51 2021-07-05 feeling hot, pain in extremity On 5/15/2021, I received my second Pfizer vaccine at around 1:40PM. Around 10:30PM, I developed hot... Read more
On 5/15/2021, I received my second Pfizer vaccine at around 1:40PM. Around 10:30PM, I developed hot sensation throughout my entire body and my left arm that received the injection as well as my bilateral inguinal lymph nodes became painful. I had restless sleep during the night because of generalized hot sensations and a sore arm. On 5/16/2021 at 11:45AM, I had bilateral groin lymph node pain. I also had tinnitus which was very apparent when there was silence. On 5/17/2021 a 5:40PM, I continued to have tinnitus, a sore left arm and sore bilateral inguinal lymph nodes. On 5/18/2021 at 4:17PM, overall, the number of side effects and their severity were less with Pfizer Vaccine #2 than with Pfizer Vaccine #1. The main side effects for Pfizer Vaccine #2 were fatigue and tiredness, tinnitus, arm pain, bilateral inguinal lymph node pain and nausea. Earlier in the day, I went to the lab to get an INR and wrote an e-mail about my symptoms to my hematologist office. By 5/22/2021, the fatigue/tiredness, arm pain, nausea and bilateral inguinal lymph node pain had subsided. The tinnitus and occasional ear pain on the left side continued but seemed to be improving. Between 5/23/2021 through 6/14/2021, my sinus pain/pressure and congestion on the left side reoccurred and lasted for about 2 days. I also continued to have intermittent sharp pain in my left ear and tinnitus. I also noticed that I was unable to hear birds chirping which I had been able to hear previously. My left ear felt shut and full and seemed to have two different pitches of tinnitus especially noticeable when the environment was quiet. I also had some tinnitus in the right ear which was of a different pitch than the left ear. My hearing did not seem as good. On 6/15/2021, I went to the local ENT to have him examine my nose/sinuses and my ear. I told him that the mometasone nasal sinus washes did appear to help the nasal pain/pressure and congestion but that a day or two after both the first and second Pfizer vaccines, the sinus nasal pain and pressure seemed to come back (despite the mometasone) and lasted for several days. I also told the ENT that after having had the first and second Pfizer vaccines that I had tinnitus; and that the tinnitus was worse in my left ear than my right ear. In addition, my hearing was not as good especially on the left side and that I was having intermittent sharp left ear pains. The ENT performed a rhinoscopy and said I did appear to still have some inflammation and congestion especially in the left side of my nose. He also examined my ears and said I had minimal ear wax and otherwise my ear exam visually looked normal. He told me tinnitus can mean hearing loss. He did a tympanogram which was normal in both ears. He did an audiogram (hearing test) which showed that the right ear had a mild loss at 250Hz then grossly normal hearing with excellent (100%) word understanding at a normal conversational level in a quiet environment. The hearing test showed the left ear had mild to slight Sensorineural Hearing Loss (SNHL) with excellent (96%) word understanding at a louder than normal conversational level, in a quiet environment. The ENT instructed me to continue my mometasone nasal sinus washes. On 6/16/2021, I went to the local PCP and explained to her that after the first Pfizer vaccine and the second Pfizer vaccine that I developed tinnitus primarily in the left ear but also the right ear. I told her I was having hearing loss, intermittent left ear pains and left sided sharp pain/pressure in my sinus and nose. I also told her that I had been having episodes of eye pains and headaches that were made worse with light. I also told her about the very painful bilateral inguinal lymph node pain that I experienced after both vaccines. I expressed concern as to the vaccine causing these symptoms via some autoimmune reaction. She prescribed for me a Medrol Dose Pack: Methylprednisolone 4mg to be taken 6 tabs on day 1 then 5 tabs then 4 tabs then 3 tabs then 2 tabs then 1 tablet.On 6/23/2021, I went to the local hematologist and discussed my sinus symptoms, left sided ear pain, tinnitus and hearing lost that occurred post-Pfizer vaccines. I explained that on 6/22/2021, I had completed the Medrol dosepack that my PCP prescribed and that the severity and number of occurrences of the loud high pitched tinnitus had decreased; but, I still had the low pitched tinnitus and hearing loss. I showed the hematologist the article, "Sudden Sensorineural Hearing Loss: Primary Care Update,". 2016 Jun; 75 (6): 172-4. I pointed out p. 173, Table, 1 which showed that Prednisone is an optimal drug for tinnitus and hearing loss: "Prednisone 60mg daily X 7 days then 40mg daily X 3 days then 20mg daily X 2 days then 10 mg daily X 2 days." The article also states, "Methylprednisolone dose packs are inadequate for therapy because of lower dosing and shorter length of treatment." My hematologist agreed it was reasonable to try a higher dose of Prednisone for a longer period of time. He also referred me a local rheumatologist for further discussion. On 6/24/2021, my local PCP prescribed the 2 week Prednisone taper outlined in the previous paragraph. I had sweating and generalized hot sensations throughout my entire body about 2-3 episodes a day (mostly at night) and lasting about 5-10 minutes while on the Prednisone Taper. My nasal congestion and sinus symptoms improved on the Prednisone taper. My ear pain has improved. I had ear popping sensations on the Prednisone Taper. The loud, harsh high-pitched tinnitus episodes decreased in frequency and intensity. I still have some low pitched tinnitus but it is not as loud. The tinnitus is worse when the surroundings are quiet. I also still have some hearing loss. On 6/29/2021, I obtained an INR which was high at 3.4. I e-mailed my hematolgist office and they felt the high INR was from the high dose Prednisone Taper. My Coumadin dose was adjusted.
51 2021-07-05 numbness, burning sensation Middle finger became numb since vaccine. Index and thumb when numb 2 weeks after. Now 3 fingers c... Read more
Middle finger became numb since vaccine. Index and thumb when numb 2 weeks after. Now 3 fingers constantly numb. Both hands has been affected ; other fingers become numb but subside. Also experiencing tightening of fingers. Awaken by burning sensations at night. Vaccine has exasperated carpal tunnel and now I experience constant pain and symptoms never experienced before.
51 2021-07-05 migraine, feeling of body temperature change Blood pressure kept steady going up, chest pain, breathing troubles, migraine, vomitting, hot and co... Read more
Blood pressure kept steady going up, chest pain, breathing troubles, migraine, vomitting, hot and cold body temp, and body aches, went to ER around 1:30 PM the same day. Exhaustion. Diagnoed with high blood pressure and myocardiovascular congestive. Still dealing with the issues, Was in ER for 14 hours then sent home.
51 2021-07-05 muscle spasms Approximately 2 weeks after the first dose, I began having muscle spasms in my right forearm...I had... Read more
Approximately 2 weeks after the first dose, I began having muscle spasms in my right forearm...I had just started playing softball again after an extended hiatus so I didn't think anything about. I went to a chiropractor for Active Release therapy to get the spasming to stop. A week later I got my second dose (5/5/21) and I went back for a second game and knelt on my right knee and started getting spasms in my right quad muscle. I switched to my left and it immediately started getting the same spasm in my left quad muscle. The spasm began in my hip muscle and continued down the front of my leg to the knee. The spasms continued to get worse over the next hour to the point I couldn't walk without significant pain. Over the next week, I began getting spasms in both legs at the same time - calves, quads, feet. I would also get spasms in my neck, my upper back and shoulders. They would hit at all times during the day and there was no warning signs.
51 2021-07-05 tingling, feeling hot, pain in extremity, impaired body coordination, feeling cold, flushing I am a Medicine Physician. I had many side effects after the Pfizer Vaccines. The first Pfizer Vac... Read more
I am a Medicine Physician. I had many side effects after the Pfizer Vaccines. The first Pfizer Vaccine side effects were worse in terms of the number and the severity of the side effects experienced. The main side effects that I am still having trouble with and going to physicians (ENT, Hematologist, and PCP) about are tinnitus, hearing loss, sinus pain and congestion, and headaches. On 4/24/2021 at about 1:30PM, the initial pain at the injection site upon injection of the first Pfizer vaccine felt like a flu vaccine. About 1 hour after receiving the first Pfizer injection, my entire face and neck became flushed. The flushing was present for 24 hours. Around 10:00PM on 4/24/2021, I developed a headache radiating to the back of my head and down my neck on the left side. I also developed severe sharp stabbing left sided sinus pain (felt like an ice pick jammed up into my nose). This pain had been been under good control with mometasone nasal washes which were started at the end of March 2021. I also developed left arm pain at the injection site that continued to worsen. During the night, I had about 3 episodes of brief 10-second-long chill-like cold tingling wave sensations from the tops of both thighs down to my feet (the soles of both my feet felt tingly) and also waves of multiple chill-like cold tingling sensations from the bottom of my rib cage and radiating up toward both shoulders and down to my elbows. When I awoke at 8:15am on 4/25/2021, my face was still flushed and my entire left arm was so painful that I could not move it. The sensation felt like it was a painful hematoma in my arm; however, fortunately, the arm showed no signs of hematoma—no bruising, no palpable hematoma. Also upon awakening, I continued to have severe sinus pain as well as left sided tooth and left jaw pain. I had left ear pain. The left ear felt like it was shut. I was slightly ataxic and felt foggy. At 9:20AM on 4/25/2021, I developed a low roaring or low-pitched harmonica sound in my ears. I also developed a severe pain in my left eye. My eyes were watering and "glassy" in appearance. Symptoms all seemed to be on the left side rather than the right side. At 10:45AM, I developed severe fatigue and laid down. While laying down, I had one chill-like cold tingling wave sensations from the tops of both thighs down to my feet and two waves of chill-like cold tingling sensations from the bottom of my rib cage and radiating up toward both shoulders and down to my elbows. I fell asleep for 3.5 hours. When I awoke at 2:15PM, it felt like I was getting up after having just been run over by a truck. My temperature was 99.5F. I continued to have a headache, mainly on the left side, throughout the day. I also had general malaise, nausea and decreased appetite the entire day. I was only able to eat 1 ½ bowls of soup, a piece of toast and a cup of hot tea for the entire day. At 3:45PM, I took Pseudoephedrine 60mg for the severe left sided sinus pain over my left eye and my headache and laid down. I had two waves of chill-like cold tingling sensations from the bottom of my rib cage and radiating up toward both shoulders and down to my elbows at 5:50 PM. The persistent left ear and jaw pain were resolved. The left sinus pain was slightly improved. The left arm was sore but slightly improved and I could move it around with less pain. I began to experience a general hot sensation over my entire body. My temperature was 99.6F. At 9:00PM, I took a shower. The shower made my arm feel slightly better. Around 10:00PM, while brushing my teeth, my forehead started to sweat and I again had hot sensations over my body. My left nose and my left arm were both sore. I had a difficult time sleeping, I had two episodes of the chill-like cold tingling sensations described above. I had nausea. I also awoke in the middle of the night to severe pain in my nose and nasal congestion used Afrin nasal spray. When I awoke at 8:30AM on 4/26/2021, I had a headache behind both eyes. My eyes were watering and they were very sensitive to light. I could barely open my eyes when I awoke because of the pain from the light of the day. My left arm pain was much improved and fully moveable. At 10:40AM, I noticed that my inguinal lymph nodes were very painful at the tops of both my thighs and walking was difficult because it made the pain worse. I also had lower back pain. At the start of the day, in terms of pain intensity: my groin lymph nodes and lower back were having the worst pain followed by the headache behind the eyes/ eye pain/ light sensitivity and then the sinus pain. I began to wonder if the vaccine was triggering some past symptoms that were suspicious of an immune/rheumatology problem whose symptoms had not been fully figured out. By 8:10PM, I was feeling that most all the symptoms were slowly improving. I still had slight left arm pain. I had a difficult time sleeping. At 5:00AM on 4/27/2021, I was sweaty, hot and nauseous a couple times. I took 1 Tums and went back to sleep. At 5:45 AM, I developed tingling sensations in the right calf for 45 minutes then chill like sensations down my entire leg twice. I fell back asleep and had bizarre dreams. I woke up startled because of a loud vacuum cleaner sound along with sounds of pots and pans banging in my ear. I had ear pain. I also heard a different mechanical type sound that moved from one side of my head to the other side of my head. I e-mailed to my hematologist at the Center about my side effects. I went to the lab to get my routine labs and INR. At 2:10PM, I developed severe fatigue and slept until 5:30PM. I had little appetite and ate half my supper. When I laid down to go to bed, I had vertigo (room spinning sensation) for about 1 minute. On 4/28/2021, most symptoms were improved or resolved. On 4/29/2021 at 1:00PM, I noted the painful inguinal groin lymph nodes bilaterally that had returned but not as severe as before. This time the lymph nodes hurt worse when sitting than standing. Originally, it hurt worse when standing. Between 4/30/2021 and the date of my second Pfizer vaccine on 5/15/2021, I continued to experience symptoms of tinnitus and occasional bilateral inguinal lymph node pain, pain in the eye/head from light sensitivity and sinus pain/headache. On 5/12/2021, I e-mailed my hematologist office at the center about my side effects.
51 2021-07-05 tingling I started out feeling feverish and chills, but no fever. Body aches and joint pain. Pins and needles... Read more
I started out feeling feverish and chills, but no fever. Body aches and joint pain. Pins and needles in hands and legs and feet and itching. In my left leg the joint pain and pins and needles has not gone away. June 19th it got so bad I could no longer walk on that leg and went to ER. they ran test and sent me home on crutches. My primary care doctor prescribed tramadol for pain. The doctor think maybe it's an inflammation response to vaccine.
51 2021-07-05 tremor Immediately post vaccination patient indicated that she was not feeling well. She started trembling... Read more
Immediately post vaccination patient indicated that she was not feeling well. She started trembling and exhibited mild confusion and irritation, but patient remained aware of self and surroundings. Patient expressed some anxiety over the long term effects of the vaccination prior to administration. Upon arrival of the ambulance and until they left with the patient, the patient continued with symptoms.
51 2021-07-06 tingling Difficulty breathing; Spike in heart rate(182 BPM); Elevated blood pressure(approximately 210/110); ... Read more
Difficulty breathing; Spike in heart rate(182 BPM); Elevated blood pressure(approximately 210/110); Severe tingling in hands and feet; Closing throat; Hives; Rash; Red blotches on skin; Itching; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 19Mar2021 13:45 (Batch/Lot Number: ER2613) at the age of 51 years old, as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included discoid lupus, hypothyroidism, asthma, allergy to sulfa, iodine, latex, shellfish, tree nuts, fruits with pits, pollen, dust mites. The patient was not pregnant at the time of vaccination. The patient received other unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, 14:00 patient experienced difficulty breathing, spike in heart rate (182 BPM), elevated blood pressure (approximately 210/110), severe tingling in hands and feet, closing throat, hives, rash and red blotches on skin, itching. The events resulted in Emergency room/department or urgent care. Treatment received for the events was Benadryl. The patient was monitored for the events. The events were reported as non-serious by the reporter. The patient was recovering from all the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
51 2021-07-07 pain in extremity, burning sensation The first day: I had symptoms of fatigue, mild headache, dizziness and buzzing in my ears, could not... Read more
The first day: I had symptoms of fatigue, mild headache, dizziness and buzzing in my ears, could not get out of bed, in the afternoon I had fever (99F), my arm was burning and it hurt. I called the Dr. and she told me the symptoms the vaccine causes (headache, burning). She told me to wait a week and if it continued to go see a doctor. I took anti-allergy medicine and it helped me. I am taking azelastine (nasal allergy) and it has helped me. 2nd day: Rapid heart palpitations (heart pounding). 3rd day: Palpitations and shortness of breath when changing positions. I also have a pain above my hip on the right side.
51 2021-07-08 muscle spasms This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EN6208) via an unspecified route of administration on 16Mar2021 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date, prior to vaccination and known allergies were reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, the patient experienced severe leg cramps which was worse at night. No treatment was received for the reported events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of severe leg cramps was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
51 2021-07-08 tenderness lymph node inflammation of varying intensity causing intermittently sore throat when swallowing, ten... Read more
lymph node inflammation of varying intensity causing intermittently sore throat when swallowing, tenderness to the touch, feeling of enlargement; also general sense or feeling of "being depleted"
51 2021-07-09 numbness, pain in extremity Patient feels painful and numbing in her both legs ,and her back . She even has a difficult of wa... Read more
Patient feels painful and numbing in her both legs ,and her back . She even has a difficult of walking. Patient seeks help at ER and they prescribed pain medication. It didnt go away even after 3 weeks. Patient came today and seek for 2nd dose of vaccine, I recommend her to seek for medical help again.
51 2021-07-09 muscle spasms Pfizer Vaccine received on 4/30/21. 5/4/21 at 2:40 am severe pain in lower abdomen, cramping - pain... Read more
Pfizer Vaccine received on 4/30/21. 5/4/21 at 2:40 am severe pain in lower abdomen, cramping - pain reduced but still present for over 12 hours. Diarrhea for the next couple days. 5/11/21 approximately 3 am pain in lower abdomen, but subsided after a few hours. Diarrhea for a few days. 5/21/21 2nd shot. That same night some menstrual bleeding and spotted next 4 days. I have not had a period since I went off the pill on 11/27/20. My FSH test shows I'm in menopause. 6/6/21 - menstrual bleeding again. 6/21 & 6/22 spotting again. 7/2/21 sever cramping in the middle of the night again. 7/5/21 menstrual bleeding. Ended on 7/9/21. I have never in my life had cramping like this and haven't had a period this "heavy" in about 7 or 8 years.
51 2021-07-09 pain in extremity Site: Pain at Injection Site-Severe, Additional Details: Pt has had ongoing arm pain that has been l... Read more
Site: Pain at Injection Site-Severe, Additional Details: Pt has had ongoing arm pain that has been life-debilitating. It started after 2nd dose on 5/9/21 and has continued ever since without resolution. Pt states they have disabled child that the pain is now interfering with her care for.
51 2021-07-10 nerve pain, pain in extremity Inability to focus/brain fog. Nerve pain on left side of body, specifically left arm, jaw, back and ... Read more
Inability to focus/brain fog. Nerve pain on left side of body, specifically left arm, jaw, back and leg.
51 2021-07-10 pain in extremity soreness in arm/shoulder; soreness in arm/shoulder; Unable to lift arm properly without pain; This i... Read more
soreness in arm/shoulder; soreness in arm/shoulder; Unable to lift arm properly without pain; This is a spontaneous report from a contactable consumer or other non HCP. A 51-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 intramuscular on 2021 (at the age of 51-years-old) as dose 1, single, and dose 2 intramuscular, administered in Arm Right on 2021 (at the age of 51-years-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was not reported whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was not reported, whether prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date in 2021, the patient experienced soreness in arm/shoulder. She was unable to lift arm properly without pain. She indicated her doctor put her on steroid to help. Has not been effective. Indicated going on 8 weeks not with little improvement. The adverse event result in doctor or other healthcare professional office/clinic visit. Information about lot/batch number has been requested.
51 2021-07-11 pain in extremity, hot flush, breast pain pain from left shoulder to fingers, swollen left lymph node, breast, chest pain left side. Severe ho... Read more
pain from left shoulder to fingers, swollen left lymph node, breast, chest pain left side. Severe hot flashes
51 2021-07-11 pain in extremity Patient said she had an immediate headache and later had pain in shoulder area, fever, blurred visio... Read more
Patient said she had an immediate headache and later had pain in shoulder area, fever, blurred vision, elevated heart rate, and pain in feet. She treated with acetaminophen and diphenhydramine.
51 2021-07-11 tingling Tingling in finger tips and tingling in toes after the second dose early the next morning. I still h... Read more
Tingling in finger tips and tingling in toes after the second dose early the next morning. I still have it.
51 2021-07-12 feeling hot, migraine the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the ... Read more
the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; I got really hot after thefirst 15 minutes which followed by amigraine headache; I got really hot after thefirst 15 minutes which followed by amigraine headache; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: ep6955), via an unspecified route of administration in the left arm on 27Mar2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Patient had previously had sulfur (MANUFACTURER UNKNOWN), azithromycin (MANUFACTURER UNKNOWN), nuts and pineapples and experienced allergy to sulfur (MANUFACTURER UNKNOWN), azithromycin (ZITHROMAX), nuts and pineapples. Previously the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: en6205), via an unspecified route of administration in the right arm on 06Mar2021 at 15:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation and had no side effects.. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 27Mar2021 at 14:45, 15 minutes after vaccination, the patient experienced feeling hot and migraine headache. After the second dose she got really hot after first 15 minutes which was followed by a migraine headache. The next day, on 28Mar2021, migraine continued along with fatigue, slept, joint aches, fever, sweats and restless sleep. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events. The clinical outcomes of feeling hot, migraine headache, fatigue, slept, joint aches, fever, sweats and restless sleep were resolving. No follow-up attempts are needed. No further information is expected.
51 2021-07-12 numbness, pain in extremity Soon after receiving the shot, I had soreness in my arm but also began experiencing numbness from th... Read more
Soon after receiving the shot, I had soreness in my arm but also began experiencing numbness from the area where I received the shot all the way down to my wrist. That soreness and numbness are still there and it has been three weeks since receiving the first shot so I am concerned that this numbness is permanent. As such I do not intend to receive the next shot for fear of my arm becoming even more numb or even losing all sensation in my left arm.
51 2021-07-12 numbness, tingling The day after the vaccine I woke up with pain in my lower neck/shoulder area. Then 5 days later thr... Read more
The day after the vaccine I woke up with pain in my lower neck/shoulder area. Then 5 days later three of my fingers on my right hand went numb. The pain can be controlled by medication, but comes back and there is continuing numbness and tingling in my right arm and hand.
51 2021-07-12 migraine achey head; achey jaw; neck leadingto migraine; Tired; achey neck; This is a spontaneous report fro... Read more
achey head; achey jaw; neck leadingto migraine; Tired; achey neck; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: er8732) via unspecified route of administration in the left arm on 24Mar2021 at 15:45 (at the age 51 -years-old), as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications included Ibuprofen (ADVIL), loratadine;pseudoephedrine sulfate (CLARITIN-D) and women's daily vitamins (MANUFACTURER UNKNOWN), from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 19:30, the patient experienced tired, achey head, jaw, neck leading to migraine which lasted 3 days. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient receive treatment with IMITREX for the adverse event migraine. The clinical outcome of the events tired, headache, neck pain and jaw pain were resolving while neck leading to migraine recovered on 27Mar2021 (third day) at the time of report. No follow-up attempts are needed. No further information is expected.
51 2021-07-12 numbness and pain in extremities Neuropathy in arms and hands
51 2021-07-12 pain in extremity Pain and weakness in left arm (upper)
51 2021-07-14 weakness, migraine 1. Migraines began 3 days after the second dose. I have had 1-2 migraines since my vaccination one ... Read more
1. Migraines began 3 days after the second dose. I have had 1-2 migraines since my vaccination one month ago. (Treatment was sleep and Advil). 2. I had spotting (slight menstruation 10 days after the vaccine). I have been through menopause and not had a period for well over 4 years. 3. I am very lethargic. I start my day with exercise and energy, but I have to come home and sleep...as in, take a serious nap around 4-5 days per week. This is very uncharacteristic! 4. My ears are ringing terribly! I'm accustomed to my slight tinnitus. But, on Monday, July 12th, they are ringing exceptionally loud.
51 2021-07-14 numbness Per client 2 days after had shortness of breath, intense headache, numbness to left side of face rad... Read more
Per client 2 days after had shortness of breath, intense headache, numbness to left side of face radiating to torse, and flu-like symptoms. On third day client went to ER where she tested negative for Covid and was prescribed Tramadol. Client states she then followed up with medical provider and was informed of high cholesterol and possible allergy to a component of Pfizer Covid Vaccine. Provider prescribed client Lipitol. Client stated symptoms resolved in 1 week.
51 2021-07-14 migraine, weakness, discomfort On day 2 after the 2nd dose vaccine, that evening I had sweats, chills and fever was 104. I took Tyl... Read more
On day 2 after the 2nd dose vaccine, that evening I had sweats, chills and fever was 104. I took Tylenol and alternate with Motrin every 6 hours. I woke up the next day, I had severe flu-like symptoms-body aches, weakness, migraines, fever, chills, dizziness, nausea and loss of appetite. I stayed in bed to rest and sleep. I went to see the doctor on 7/1/2021 because I developed a urinary infection and pneumonia. I had shortness of breath, fatigued, low grade fever, urinary pressure and frequency and urgency. They did blood work, urine culture and CT scan which confirmed pneumonia and UTI. I was prescribed Levaquin which has resolved both my UTI and pneumonia. I am still suffering from symptoms and side effects from the vaccine. I have daily full body pains and aches, headaches, fatigue, chills, loss of appetite and unable to work or do normal daily activities.
51 2021-07-14 migraine, weakness Developed a migraine and stiff neck and back aches exactly 1 week after the 2nd Covid shot. Just wok... Read more
Developed a migraine and stiff neck and back aches exactly 1 week after the 2nd Covid shot. Just woke up in pain. A week later I lost vision, everything was blurry for 2 weeks any time I was walking, and could not drive. Went to 2 emergency rooms, was in the hospital for 2 days. Was in and out of work for a month. Had to use short term disability.
51 2021-07-14 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
51 2021-07-15 electric shock sensation, tingling Vertigo (off and on for about 6 hours) Pins and needles/electric shock feeling felt from both should... Read more
Vertigo (off and on for about 6 hours) Pins and needles/electric shock feeling felt from both shoulders down to fingers and both upper legs down to toes (extremely bad and painful for about an hour then off and on at a milder level every few days since vaccination) Nausea (off and on for about 12 hours) Fever (100-101 F for about 24 hours...took Extra strength Tylenol and alternated with baby aspirin for 3 doses each) Tinnitus (extremely bad for about 12 hours, then a bit less but ongoing symptom continues even today) "Weak in the knees" with some pain while walking (off and on for about 1 week) Headache and back ache (daily for about 2 weeks...took Tylenol or baby aspirin as needed when pain was really bad) Extreme Fatigue/lightheaded (extreme for 4 days, symptom continues off and on up to today) Insomnia (extreme for 1 week, symptom continues off and on for about 2 days each week up to today) Heart palpitations (off and on almost daily) Pain and warmness at injection site (for about 4 days)
51 2021-07-15 feeling hot The day after receiving her 1st dose of the Pfizer COVID vaccine on 6/11/21 patient reports having f... Read more
The day after receiving her 1st dose of the Pfizer COVID vaccine on 6/11/21 patient reports having flue like symptoms, throwing up, body ache, diarrhea, but denies a fever. These common side effects did not resolve and got worse. On 7/1/21 patient says she was feeling over heated and hot, was vomiting and even lost consciousness (passed out). On 7/2/21 she got her second dose of the Pfizer vaccine and her side effects have continued. She passed out again and was hospitalized from 7/13/21 to 7/14/21. As of today patient reports vomiting and dry heaving has continued and overheating.
51 2021-07-15 flushing, unresponsive to stimuli, flushing Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: D... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
51 2021-07-15 muscle spasms, numbness "Pt w/ hx of allergy to oxazepam (numbness & HTN) and an unknown food allergen. S/p kidney removal @... Read more
"Pt w/ hx of allergy to oxazepam (numbness & HTN) and an unknown food allergen. S/p kidney removal @ 2yrs of age. Possible Hx of GERD vs. Anxiety. Pt had an allergic rxn to Chinese food w/ in 1 month of Covid Vaccine. Treated w/ steroids. Pt developed redness of the skin and dizziness starting 30mins post vaccination. Itchy rash developed within 4hrs on the temple, ears, chest that mostly resolved the same day. Pt continued to have dizziness and developed foot cramps, intermittent sharp pains in right ear, intermittent chills for the next 2 days. June 6, pt had severe stomach pain and diarrhea x2. June 7 pt had throbbing pain on the side of the head. Pressure on the front of the head and foot numbness persisted until June 21. Pt developed SOB and palpitations June 23 and went to ED (likely unrelated GERD vs. Anxiety)."
51 2021-07-15 pain in extremity Inability to move left arm -severe pain and frozen in motion
51 2021-07-16 migraine right lung pulmonary embolism; heart palpitations; fatigue worst; vomiting; low grade fever; low blo... Read more
right lung pulmonary embolism; heart palpitations; fatigue worst; vomiting; low grade fever; low blood pressure; headache on and off; migraine; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Manufacturer (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-065358), license party for apixaban (ELIQUIS). This case was received via Agency (Reference number: 20K-163-3399863-00) on 01-Jul-2021 and was forwarded to Manufacturer on 02-Jul-2021. This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (right lung pulmonary embolism) in 51-year-old female patient who received apixaban (ELIQUIS) for an unknown indication. The occurrence of additional non-serious events is detailed below. CO-SUSPECT PRODUCTS included adalimumab (HUMIRA) solution for injection in pre-filled pen for Disease Crohns, methotrexate (OTREXUP) for an unknown indication and COVID-19 Vaccine for an unknown indication. The patient had Ileostomy bag for stool and she emptied her ileostomy bag about five times per day. Patient was not being able to do things friends can do. The patient's past medical history included Rectal bleeding (Patient had rectal bleeding with mucus. Patient had an unknown surgery on 31-Aug-2020 to remove the rectal area and other parts of the bowel because of heavy rectal bleeding. Patient almost always had stomach pain that moved to left side, blood and mucus from rectum) in 2020, Feeling unwell (Missing work because of not feeling well) in 2020, Disability, Appetite decreased NOS (not feeling hungry) in 2020, Weight loss (weight loss about seven pounds) in 2020, Nausea (On an unspecified date in May 2020, the patient experienced sore rectum area/both sides inside vagina/genital herpes outbreak. On 11-May-2020, the patient experienced chills/freezing, feeling drained/weak, bloated upper abdominal pain, nausea and bloated upper abdominal pain/stomach pain moving to left side. In 2020, stomach pain resolved) on 11-May-2020, Feeling sad, Stool bloody (liquid stool with blood), Smoker (everyday smoker), Abstains from alcohol, Back surgery, Fistula (fistula between vagina and rectum), Fatigue (Patient had fatigue which was present prior to HUMIRA had improved but still ongoing) in 2020, Anxiety in 2020, Depression, Kidney stones, Bleeding (The patient was hospitalized from 28-May-2020 to 06-Jun-2020 due to bleeding and pain. She was on disability and was not working. She had up to five liquid stools per day and after start of therapy symptoms worsened) in 2020, Arthralgia (especially in ankles) in 2020, Pain stomach in 2020, Difficulty sleeping, Chills (chills that felt like freezing) on 11-May-2020, Genital herpes in May 2020, Bloating on 11-May-2020, Rectal pain in May 2020, Injection site pain in 2020 and Stools watery in 2020. In December 2020, the patient started ELIQUIS (unknown route). On 17-Mar-2020, the patient started HUMIRA (Subcutaneous) 160 mg once, day 1. On 05-May-2020, the dose was changed to 80 mg once, day 15. In May 2020, the dose was changed to 40 milligram every week. In 2020, the dose was changed to 40 mg once in 14 days. On an unknown date, the patient started OTREXUP (unknown route). On 03-May-2021, the patient started COVID-19 Vaccine (unknown route). In 2020, the patient experienced MIGRAINE and HEADACHE (headache on and off). On 04-May-2021, the patient experienced VOMITING and PYREXIA (low grade fever). In May 2021, the patient experienced HYPOTENSION (low blood pressure). On 25-May-2021, the patient experienced PULMONARY EMBOLISM (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 25-May-2021 to 27-May-2021 due to Pulmonary embolism. The patient was treated with paracetamol (TYLENOL) and alprazolam (XANAX). The action taken with ELIQUIS (Unknown) was unknown. In 2020, MIGRAINE resolved. In May 2021, VOMITING and PYREXIA resolved. At the time of the report, PULMONARY EMBOLISM, PALPITATIONS, HYPOTENSION and FATIGUE outcome was unknown and HEADACHE did not resolve. On 03-May-2021, the patient received COVID-19 vaccine and the next day patient had vomiting, low grade fever, headache which resolved in a week. On 21-May-2021, patient had pain in chest, trouble breathing was in emergency room on 24-May- 2021. She was admitted to hospital on 25-May-2021 and diagnosis of right lung pulmonary embolism done. Patient's blood pressure was low during hospitalization. Patient was discharged home on 27-May-2021. Patient's physician heard heart palpitations. Patient stated that chest was still sore, feels winded, but better than before. She reported fatigue worst, ongoing headaches, shortness of breath, feels cold and clammy since discharged unsure if these symptoms were from the lung embolism. The nurse saw the patient last time for consultation was 27-May-2020 and the last prescription refill was in Oct-2020. The patient was not advised to discontinued taking HUMIRA and from the most recent order of the doctor in 19-Jun-2020, the patient was due to continued taking HUMIRA. The strength of HUMIRA (adalimumab) was 40mg/0.4ml (40 mg, Solution for injection in pre-filled pen). The action taken with co-suspect drugs OTREXUP (methotrexate) and COVID-19 Vaccine were unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Pain assessment: 6 to 7 out of 10 and Weight: weight loss of three to four pounds. In May 2021, Blood pressure measurement: low. On 25-May-2021, Scan: right lung pulmonary embolism. For ELIQUIS (Unknown), the reporter did not provide any causality assessments. Manufacturer Medical Evaluation Comment: This patient was hospitalised due to pulmonary embolism after receiving apixaban therapy along with adalimumab and methotrexate. This patient also get vaccinated for COVID-19. Underlying thromboembolic susceptibility as ascertained by the use of apixaban is likely the risk factor for the reported event and is considered as not related to the suspect. Causality Assessments Drug: Eliquis Pulmonary embolism, Migraine, Palpitations, Intermittent headache, Fatigue aggravated, Vomiting, Low blood pressure and Low grade fever Per Reporter = No Information Per Company Manufacturer = Not Related; Sender's Comments: Manufacturer does not attribute the events to (ELIQUIS).
51 2021-07-17 cold sweat, tingling Dizziness/faintness; Cold sweat; Tingling in left arm; Fatigue; This is a spontaneous report receive... Read more
Dizziness/faintness; Cold sweat; Tingling in left arm; Fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration in the left arm on 24Mar2021 at 16:30 (at the age of 51-years-old) as single dose for COVID-19 immunisation. Medical history included eosinophilic esophagitis. The patient did not had allergies to medications, food, or other product. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) of 40 mg and ibuprofen (ADVIL) received on unspecified dates for unknown indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 16:45, the patient experienced sudden onset of dizziness/faintness and cold sweat approximately 15 min after receiving shot, while waiting in monitoring area, tingling in left arm and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for adverse events. The clinical outcome of dizziness/faintness, cold sweat, tingling in left arm and fatigue were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
51 2021-07-17 difficulty speaking Joint pain; sore throat; Hoarseness; This is a spontaneous report from a contactable consumer or oth... Read more
Joint pain; sore throat; Hoarseness; This is a spontaneous report from a contactable consumer or other non-HCP (patient's daughter). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Apr2021 (at the age of 51-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), dose 1 via an unspecified route of administration on 27Apr2021 as dose 1, single for covid-19 immunisation. The patient received the vaccine in Mar2021 or Apr2021. The patient has been experiencing hoarseness/sore throat (voice was horse) which started 3 months ago (in 2021), since then and joint pain a week after her Pfizer shot in Apr2021. The reporter would like more information about the side effects, reclarified the hoarseness and joint pain and asked were these common side effects, and what should be the next steps, treatment. The patient went to the doctor about these issues, and they could not find a solution. This has been ongoing for 3 months, and she was a normally well person, with no health issues. She asked what the next steps for her side effects response were, provided disclaimer that Pfizer does not provide treatment recommendations or clinical interventions.The patient required the physician office visit for the adverse events. The outcome of the events was not recovered.
51 2021-07-17 numbness Numbness at the level over the skin; Vision got a little blurry/shaky; This is a spontaneous report ... Read more
Numbness at the level over the skin; Vision got a little blurry/shaky; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old-non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8734) via an unspecified route of administration in the arm left on 28Mar2021 at 14:30 as a single dose (at the age of 51-years-old) for COVID-19 immunisation. The medical history of the patient was reported as migraine. The patient had strong reactions to amoxicillin and allergies to wheat, blueberries and eggplant. The patient received concomitant medications included as Naratriptan (MANUFACTURER UNKNOWN) for an unknown indication, Nortriptyline (MANUFACTURER UNKNOWN) for an unknown indication, Naproxen (MANUFACTURER UNKNOWN) for an unknown indication and the patient received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206) via an unspecified route of administration in the arm left on 07Mar2021 at 14:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 28Mar2021 at 15:00, after 30 minutes of vaccination the patient was experienced numbness at the level over the skin and vision got a little blurry/shaky. The patient reported as numbness was beginning in the center of face about 20-30 minutes after the injection. It was speeded across the body. The numbness and vision issues dissipated by the next morning. The patient did not received treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of numbness at the level over the skin and vision got a little blurry/shaky were recovering. No follow-up attempts are needed. No further information is expected.
51 2021-07-17 pain in extremity Sore arm; Itchy feets; Itchy hands; This is a spontaneous report from a non-contactable consumer, th... Read more
Sore arm; Itchy feets; Itchy hands; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the arm left on 24Mar2021 at 09:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergy. Concomitant medications included ibuprofen sodium (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 10:30 the patient experienced sore arm, for 36 hours after vaccine, itchy hands and feet 1 hour after vaccine that lasted 1 hour and the same irritation occurred the second morning after the vaccine for about 2 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event sore arm resolved on 26Mar2021 at 22:30 and that of events itchy feet and itchy hands was resolved with sequelae on 24Mar2021. No follow-up attempts are needed. No further information is expected.
51 2021-07-17 pain in extremity Low grade fever; chills; nausea; fatigue; sore arm; This is a spontaneous report from a contactable ... Read more
Low grade fever; chills; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) in the left arm at 23Mar2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included ulcerative colitis (reported UC). The patient's concomitant medications taken in two weeks included vitamin B12 (MANUFACTURER UNKNOWN) and mesalamine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) at 10:00 (at the age of 51-years-old) in the left arm on 01Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 22:00, the patient experienced low grade fever, chills, nausea, fatigue and sore arm. Therapeutic measures were not given as a result of fever, chills, nausea, fatigue and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, nausea, fatigue and sore arm was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.
51 2021-07-17 pain in extremity injection site is red, warm, swollen, and sore; injection site is red, warm, swollen, and sore; inje... Read more
injection site is red, warm, swollen, and sore; injection site is red, warm, swollen, and sore; injection site is red, warm, swollen, and sore; injection site is red, warm, swollen, and sore; left arm was in severe pain; This is a spontaneous report from a contactable consumer or other non hcp. A 51 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jun2021 16:00 (Batch/Lot Number: EL00217) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune Hashimoto's thyroiditis from an unknown date and unknown if ongoing for past 5.5 years , infectious mononucleosis from an unknown date and unknown if ongoing for past 5.5 years. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; creatine (CREATINE) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX (B50)) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported. The patient previously took Depakote and imipramine and experienced drug hypersensitivity. From about 8 hours after the shot until about 44 hours later, the patient experienced left arm severe pain on 26Jun2021 with outcome of recovered. Also had injection site redness, warmth, swollen, and sore on 02Jul2021 04:00 with outcome of not recovered. Follow-up (06Jul2021): Follow-up attempts are completed. No further information is expected.
51 2021-07-17 pain in extremity Sore arm; Chills; Nausea; Low grade fever; Headache; This is a spontaneous report received from a co... Read more
Sore arm; Chills; Nausea; Low grade fever; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old female (non-pregnant) patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration on the left arm on 19Mar2021 at 12:00 (at the age of 51 years), as a single dose for COVID-19 immunisation. Patient medical history included COVID-19. Patient concomitant medication included vitamin D (MANUFACTURER UNKNOWN) and armour/thyroid (MANUFACTURER UNKNOWN) for unknown indications from unknown date. The Patient did not have any allergies to medications, food, or other products. No known allergies ware reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccintion. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. The patient experienced sore arm, chills, nausea, low grade fever and headache on on Mar2021. The patient did not receive any treatment for the reported events. The clinical outcome of sore arm, chills, nausea, low grade fever and headache was recovering. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information.
51 2021-07-17 pain in extremity Achy; Pain in arm; Fever; Chills; Headache; nausea; Lightheaded; This is a spontaneous report from a... Read more
Achy; Pain in arm; Fever; Chills; Headache; nausea; Lightheaded; This is a spontaneous report from a contactable consumer. A 51-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 24Mar2021 at 12:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient medical history included many (unspecified details).The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 03Mar2021 at 12:15 PM(at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had allergies to medications, food, or other products. The patient received unspecified medication within 2 weeks of COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19.On 25Mar2021 the patient at 01:30, experienced achy, pain in arm, fever, chills, headache, lightheaded and nausea. The patient did not receive any treatment for the events. The clinical outcome of achy, pain in arm, fever, chills, headache, lightheaded and nausea was recovering at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-07-17 seizure I also had a seizure like episodecat night where I nearly bit my tongue off; 3 minutes after I had a... Read more
I also had a seizure like episodecat night where I nearly bit my tongue off; 3 minutes after I had an altered mental experience, also twice in the war home. I have since had one a week but they are increasing in frequency I had four yesterday; I also experience some memory loss and sometimes am very emotional or have a headache aftwrwards; I also experience some memory loss and sometimes am very emotional or have a headache aftwrwards; I also experience some memory loss and sometimes am very emotional or have a headache aftwrwards; I have itinerant chest pain in addition; This is a spontaneous report from a contactable consumer (reporting for herself). A 50 year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: En9581), via an unspecified route of administration on 28Jan2021 at 09:15 (at the age of 51-year-old), as dose 1, single in right arm and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EI9826), via an unspecified route of administration on 17Feb2021 at 09:00 (at the age of 51-year-old), as dose 2, single in right arm for COVID-19 immunization. The patient's medical history included nine. Concomitant medications within 2 weeks of vaccination included vitamin D NOS (VITAMIN D), taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021, at 09:15 AM, the patient experienced seizure like episode cat night where she nearly bit her tongue off. 3 minutes after she had an altered mental experience, also twice in the war home. Patient had one a week, but they were increasing in frequency she had four in the previous day. Patient visited the emergency room and neurologist after that. The patient also experienced some memory loss and sometimes was very emotional or had a headache afterwards. Patient had itinerant chest pain in addition. Treatment received for the events included EEG (Electroencephalogram) upon neurology visit. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was reported as not resolved.
51 2021-07-18 numbness, pain in extremity Location of site: At my job building. Throbbing pain hasn't stopped. Please help
51 2021-07-18 numbness I got shingles after the second dose. I went to the walk-in clinic; I had a side ache which was bur... Read more
I got shingles after the second dose. I went to the walk-in clinic; I had a side ache which was burning and itching and numb. They prescribed a 7-day treatment for the symptoms I was having. They medication did help the symptoms. But I did get a rash about 3 days into the treatment. The rash was raised and elevated, then it went away.
51 2021-07-18 tingling, night sweats I was on my menstrual cycle and then a few hours after getting the vaccine it had just stopped. I ha... Read more
I was on my menstrual cycle and then a few hours after getting the vaccine it had just stopped. I had a severe headache that didn't go away for over a week and a half. I seeked medical care. I developed night sweats and heart complications. My GYN said my hormones were whacked. I had to be put on hormone therapy. I did a B12 shot to reduce it. My sense of smell reduced for about a half a day. I felt extremely fatigued to the point to where I couldn't do anything. I was in pain everywhere. Things that hurt before in the past started hurting again. I had loose stools. I still have issues with hormones and being able to absorb B vitamins. I can't take oral B Vitamin because my body is not absorbing it. My PCP put me on a bunch of enzymes and amino acids. I am being treated as if I was poisoned. I have been advised not to take the second covid shot because of the MRNA and my reaction to the first shot. I have nerve tingling issues and brain fog. I am now in the process of dealing with disability.
51 2021-07-19 slurring June 24th I received the vaccine, June 25 a baseball sized "knot" formed under my right arm. On Jul... Read more
June 24th I received the vaccine, June 25 a baseball sized "knot" formed under my right arm. On July 2nd i was rushed to the Emergency dept . with what was described as "vertigo". I returned to the hospital at my doctors behest because i was not able to use my right hand correctly and my speech was slurred. after a MRI was done it was determined that i had had a stroke.
51 2021-07-19 pain in extremity, nerve pain, hot flush, electric shock sensation, burning sensation shot @5:44 pm by 8:00 pm severe pain due to "dead arm" lasted from 6/30/2021 to 7/3/2021. On 7/1/202... Read more
shot @5:44 pm by 8:00 pm severe pain due to "dead arm" lasted from 6/30/2021 to 7/3/2021. On 7/1/2021 the following began: hot flashes, temp 100.1, severe headache (behind the eyes), severe body aches, severe bone achiness, "electric burning" body cell pain (generalized nerve pain) --as if every cell was being zapped with electricity, more frequent/longer lasting hot flashes with markedly increased profuse body sweating, fatigue, claustrophobia accompanying hot flashes. By 07/17 all but the hot flashes and Shingles symptoms/pain resolved. New urgent care visit for hotflashes/shingles 07/17-18/2021
51 2021-07-19 pain in extremity Injection site soreness; arm soreness; tiredness; This is a spontaneous report from a contactable co... Read more
Injection site soreness; arm soreness; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies to medications, food, or other products. Concomitant medications included calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 16:00, the patient experienced injection site soreness, arm soreness and tiredness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of injection site soreness, arm soreness and tiredness were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
51 2021-07-19 pain in extremity Right arm pain radiating to neck and left shoulder, SOB and chest pressure
51 2021-07-20 numbness, pain in extremity, tingling Per provider visit note: pt had second Covid 19 vaccine on 5/19/21. Vaccine was given in L arm. She... Read more
Per provider visit note: pt had second Covid 19 vaccine on 5/19/21. Vaccine was given in L arm. She states since she had the vaccine she has had some numbness and tingling of her L arm. Feels pain at site of vaccine, radiates down her Left arm into hand and all fingers. She is convinced this is caused by the vaccine. She states she absolutely did not have any of these symptoms prior to getting vaccine. This pain is daily. Sometimes she has stabbing sensation in her heart/ chest area. Pain sometimes radiates up into L side of neck. She did have a lot of redness at injection site that lasted 5-6 days. Pt scored a 25 on her PHQ9 today. She is taking Sertraline 50 mg daily. She has been taking this since April. She does not feel as though the Sertraline is helping at all. She has custody of her 6 grandchildren and is under a lot of stress.
51 2021-07-20 pain in extremity By 3 pm on July 13, 2021, I started feeling very nauseated. Then fever began. I started throwing up ... Read more
By 3 pm on July 13, 2021, I started feeling very nauseated. Then fever began. I started throwing up in the bathroom. My whole body started hurting, especially in my legs. Injection site soreness in my left arm. This continued for the next 3 days. On July 14 at 8:45 am spoke with someone (on the phone visit) from health center about how I was feeling. She advised me to drink plenty of fluids and just rest and keep her up to date if things got worse. By Friday, July 16th, my fever was gone, nausea was gone, pain in my legs was gone. I started to feel a little better!
51 2021-07-21 weakness fatigued; Very little energy; colitis; Stomach issues; My bowel movements now have a gel layer on it... Read more
fatigued; Very little energy; colitis; Stomach issues; My bowel movements now have a gel layer on it.; Blood in my stool; This is a spontaneous report from a contactable consumer reported for herself. This 51-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 29Apr2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Patient was not pregnant. Medical history included arthritis. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); levothyroxine (LEVOTHYROXINE); hydrocodone bitartrate, paracetamol (NORCO); morphine sulfate (MS CONTIN). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 at age of 50 years old on 22Mar2021 04:45 PM in left arm for COVID-19 Immunization, and experienced fatigued/tired, fall asleep. In 2021, after the second shot patient still had days she got very fatigued and had very little energy. Also, suddenly had some type of colitis that she had never had. She had to be careful on what she eat or feel sick. She ended up with blood in stool. She was awaiting a colonoscopy but continual had stomach issues. Her bowel movements now have a gel layer on it. Events resulted in Emergency room/department or urgent care, and patient was hospitalized for 3 days. Treatment included a diet of just liquids and worked up to solids. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on lot /batch number has been requested.
51 2021-07-21 tension headache Pt. states that after receiving the 1st dose of Phizer 06/23/2021, woke up 06/24/2021 with extreme v... Read more
Pt. states that after receiving the 1st dose of Phizer 06/23/2021, woke up 06/24/2021 with extreme vertigo and cracking sound inside the back-side of the head. noted with Physician visit, prescribed HBP Metoprolol. ENT exam noted swelling in inner-ear and surrounding area. Prescribed Amoxicillin. Feeling of her head is under water and tension - on the left side.
51 2021-07-22 muscle spasms, numbness, tingling, mild one side paralysis, pain in extremity Noticeable Symptoms immediately after the 2nd shot - chills and sweating. Months after the 2nd shot... Read more
Noticeable Symptoms immediately after the 2nd shot - chills and sweating. Months after the 2nd shot: Metallic taste - unable to eat, food tasted nasty Left shoulder and arm constant pain, especially when I lay down (Like constant cramping) Left hand fingers - numbness and tingling Left leg weakness Left hand weakness - hard to grip anything Demyelization to Pons and Superior Cerebellar region - ruled out MS and stroke, double vision cleared up after a month Dr. ( Ophthalmologist) prescribed Prednisone 20mg tab once a day and Pyridostigmine BR 60mg tab 3 times a day - suspected Myasthnia gravis or other autoimmune disorder
51 2021-07-22 tingling Tingling; weakness in hand; This is a spontaneous report from a contactable consumer, the patient. A... Read more
Tingling; weakness in hand; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 02Apr2021 at 11:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to some antibiotic. Concomitant medications included cannabidiol (CBD OIL), diclofenac (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN) and famotidine (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 11:30, 1-2 minutes after the shot, the patient experienced tingling in hand and weakness in hand which continued for 36 hours. The patient did not receive any treatment for the reported events. The clinical outcome of the event tingling and hands weakness of was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
51 2021-07-23 nerve injury Sudden sensorineural hearing loss (SSHL), commonly known as sudden deafness; Right ear had a sudden ... Read more
Sudden sensorineural hearing loss (SSHL), commonly known as sudden deafness; Right ear had a sudden build up of fluid behind my ear drum; Nerve damage; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female non pregnant patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: FP7533) via an unspecified route of administration and administered in right arm on 04Apr2021 15:00 (at age of 51-years) as single dose and dose 2 via an unspecified route of administration and administered in right arm on 04Apr2021 (Batch/Lot Number: ER8736) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received drugs within in 2 weeks prior to the COVID 19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient not tested for COVID-19. The patient medical history was not reported. The patient previously took sulfa [sulfadiazine] and experienced drug hypersensitivity. On 10Jun2021, my right ear had a sudden build up of fluid behind my ear drum. By the time I saw the referral ENT doctor, on 09Jun2021 it was determined that the fluid had drained away but nerve damage was suspected. Sudden sensorineural hearing loss (SSHL), commonly known as sudden deafness. On 16Jul2021 I will be having a MRI performed to rule out Acoustic Neuroma. Then hopefully I can start with direct intratympanic injection of steroids into the middle ear. However, the doctors felt that it might be too late to regain full hearing back into that ear. That the nerve damage is permanent. the adverse event result in disability and Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with Prednisone. The outcome of events was not recovered.
51 2021-07-26 inability to speak, migraine had dizziness and fatigue shortly after first vaccine, extreme sinus drainage started a couple days ... Read more
had dizziness and fatigue shortly after first vaccine, extreme sinus drainage started a couple days later, had 4 migraines in 2 weeks after vaccine, had stomach ache/nausea that started within a couple weeks after. saw pcp 3 times 1/11/21 through 1/21/21. dizziness lasted about 3 weeks. treated it with motion sickness medication (OTC). treated sinus drainage with neti pot, OTC allergy medicine, and Flonase spray. treated migraines with naratriptan and zofran and aleve. after second vaccine on 1/27/21, had dysphasia. saw PCP for this on 4/9/21, 5/4/21, and had endoscopy on 6/25/21-results showed narrowing of and inflammation of esophogus. have also had increased frequency of migraines since COVID vaccines. Have had 20 already in 2021, while only had 18 total in 2020.
51 2021-07-27 burning sensation Pain in the christ and brain, I feel something burning un my brain
51 2021-07-27 feeling cold She's been feeling cold (her body is feeling cold); Cough; Feels like her throat is inflamed; Has no... Read more
She's been feeling cold (her body is feeling cold); Cough; Feels like her throat is inflamed; Has not been able to go to work; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported, age at vaccination: 51-year-old), via an unspecified route of administration on 07Jul2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient had been feeling cold (her body is feeling cold). She has a cough and she feels like her throat is inflamed. She has not been able to go to work and now her company/employer is asking her for some papers from her doctor. She was wondering if she needs to book an appointment for that. So, she was referred her doctor. The outcome of events was unknown. Information on the lot/batch number has been requested.
51 2021-07-27 numbness, tingling, pain in extremity The first week in May, I began experiencing numbness, tingling, pins/needles in both of my arms and ... Read more
The first week in May, I began experiencing numbness, tingling, pins/needles in both of my arms and hands at night when laying down. The right side was worse than the left and was very painful at times. Had milder symptoms sometimes when sitting or raising my arms above my head. Thought it may part of menopause, so I did not go to the doctor right away. Called my OBGYN and she recommended I see my PCP. At the time, I did not consider that this may a reaction to the vaccine. To date, symptoms have improved, however they are not completely gone. Wanted to report these symptoms in case it is related to the vaccine because I have never experienced anything like it before.
51 2021-07-27 pain in extremity a painful lump that appears to be swollen; sore arm; sick a little bit; underarm was swelling/lump i... Read more
a painful lump that appears to be swollen; sore arm; sick a little bit; underarm was swelling/lump in underarm; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in right arm on 20May2021 as dose 1, single for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient did not received any other vaccine on same day or within four weeks prior to the first administration date of the suspect vaccine. Patient had no problems with vaccines in past. Family medical history relevant to AEwas none. The patient experienced a painful lump that appears to be swollen in which the lump was "very very obvious.", sore arm, sick a little bit, underarm was swelling/lump in underarm, swollen under the right arm where she got the vaccine on an unspecified date in May2021. It was reported that, patient received the first COVID vaccine last Thursday and she was told that it would be sore and she would be sick a little bit and experienced both and that was okay. 2 days after getting it her underarm was swelling in the same arm she got the vaccine and she felt pain and a lump in the underarm. Went to touch it and it was swollen under the right arm where she got the vaccine. She got it in the right arm since she was left handed. It was so weird and had not experienced any side effects like this before. Patient wanted to know what could she do about the pain and swelling and was this normal side effects she had since this was 2 days after the vaccine. Patient was unable to provide primary care provider. Got the first dose on 20May2021. Again mentioned felt the swelling in the underarm 2 days after getting it. She could feel the lump when she pushes one part of the underarm and saw a lump underneath it. She was scheduled for the second dose in 3 weeks. Patient reported that, she was super healthy person and had no problems. Did not even took any medication for headaches or anything, not even Motrin. No further details provided. The outcome of the events was not resolved. Information on the lot/batch number has been requested.
51 2021-07-27 pain in extremity Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 51-year-old fema... Read more
Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EN6201) via an unspecified route of administration, administered in Arm Right on 25Apr2021 11:30 (at the age of 51-years-old) as single dose for covid-19 immunization. Medical history included hypertension from an unspecified date and ongoing. She doesn't know when the blood pressure started, around 2018 to 2019. She had the Afib maybe 2 years ago, so 2019. AFib (atrial fibrillation) from an unknown date in 2019 to an unknown date. She has high blood pressure. She is extremely young to have this, but she had been in the hospital once for Afib which typically happens to people that are older, unhealthy, overweight, and in their 70s or 80s. When she was in the hospital everyone said she didn't belong there. It is rare to be young and have it to the extent she did. She has an underlying condition that is very critical for her. God forbid she catches Covid. The patient's concomitant medications were not reported. It was reported that the patient arm was sore on 26Apr2021. She was expecting her arm to be sore. Everyone said when they got the shot it will feel sore. For her it felt like when she works out too hard and hasn't worked out and is just sore. It was nothing alarming to her. After her first shot she was sore by late afternoon or evening the next day. She had the first dose on 25Apr2021. She had all those tests done recently prior to the Covid shot she would say in December 2020. She had a lot of workups done bloodwork-wise and everything else. The outcome of the event was unknown. Additional information has been requested.
51 2021-07-27 tremor, numbness Body was itching; Headache; Body is aching; Body pain; Numbness; Rash is still on my face and my che... Read more
Body was itching; Headache; Body is aching; Body pain; Numbness; Rash is still on my face and my chest; Eyes are red and itchy; Eyes are red and itchy; I have to be shaking shaking my self something; Joints are hurting me; Face is little bit swollen; Throat, I can't even eat anything; Loose appetite; This is a spontaneous report from a contactable consumer (Patient reported for herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0187) via an unspecified route of administration, administered in arm left on 08Jul2021 at 12:10 pm (at the age of 51-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history related to event. The patient had no Family medical history related to event. There were no concomitant medications. No vaccination received 4 weeks prior to COVID 19 Vaccine. On 08Jul2021, at night after the vaccination, the patient experienced body was itching, headache and body was aching, body pain. On an unspecified date in Jul2021, it would be 10 to 12 hours time after the vaccination, the patient experienced, joints hurting, face was little bit swollen, throat she cannot even eat anything, loose appetite, numbness, rash still on her face and her chest, eyes are red and itchy. The clinical course of the events as follows: she stated she took the first dose of Pfizer Vaccine on Thursday on 8thJul. The very day she took it, and she waited there for 15 minutes and then she went to home in the night. She could believe it would be 10 to 12 hours time, I was (incomplete sentence). She felt that her body was itching and the whole night she felt headache and her body started aching. She continued having headache, body ache, and even her joints were hurting, it came to a point, her thigh, the leg to the bottom of her buttock was trying to be numb and she had to be shaking herself something. She stated that she put alcohol to stop the itching and then she takes Tylenol for headache almost every 4 hours, she said that she put alcohol on her face, the part which was itching the most and because of that alcohol she put it, her skin turned black. Her face was little bit swollen and her throat, she cannot even eat anything and she loose appetite. She stated the numbness would not stay for long but the itchy and rash was still on her face and her chest. She stated that she does not know if she is supposed to go to the ER. She stated that her second dose is supposed to be on 29thJul. She reported basically, it stays the same as the first time she experienced the rashes, it was the same and not going away and it was not getting worst either. No Investigation Assessment was provided. The outcome of the events body was itching, and rash was still on her face and chest was not resolved and the outcome of the other events was unknown at the time of this report.
51 2021-07-28 pain in extremity, breast pain Swollen lymph nodes in right breast; Feeling breast pain; Tenderness down part of arm, on the side; ... Read more
Swollen lymph nodes in right breast; Feeling breast pain; Tenderness down part of arm, on the side; Tenderness in under arm/armpit; This is a spontaneous report from a contactable pharmacist, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma and Monosodium Glutamate (MSG) intolerance. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received type 1 antihistamines and experienced slight allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 17:30, 5 days after the vaccination, the patient experienced swollen lymph nodes in the right breast, axils and underarm and felt breast pain, tenderness under arm, down part of arm, on the side and in armpit. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swollen lymph nodes in right breast, axils and underarm and felt breast pain, tenderness under arm, down part of arm, on the side and in armpit was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-07-28 pain in extremity I developed a new and unexplained pain in my knees and elbows, feet, and hips. The pain feels like a... Read more
I developed a new and unexplained pain in my knees and elbows, feet, and hips. The pain feels like a stabbing knife into the area of pain. Most of the time it happens simultaneously with both knees and both elbows. Once it begins I get so bad I can barely stand or walk. I tried Bayer, Aleve, Aspercreme, Valteran, CBD, and vitamins. I went to a couple of doctors and they treated me with Prednisone and that has helped. If I try to go 3 days or more without the steroids I can not walk, get out of bed, work, walk, etc.
51 2021-07-28 tingling, pain in extremity, numbness Right arm pain in lymph nodes in underarm; Pain radiating from shoulder to fingers; Fingers numb; Fi... Read more
Right arm pain in lymph nodes in underarm; Pain radiating from shoulder to fingers; Fingers numb; Fingers numb and tingling; Pain on right side of body below shoulder; Right arm pain increases as the day goes on and with use.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 20Mar2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer in 2012, lymphoedema in left arm and mastectomy bilateral in 2012. The patient had no known allergies to medications, food, or other products. Concomitant medications included tapentadol hydrochloride (NUCYNTA) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN602) via an unspecified route of administration in the right arm on 27Feb2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 14:00, the patient experienced right arm pain in lymph nodes in underarm, pain radiating from shoulder to fingers, fingers numb and tingling, pain on right side of body below shoulder and right arm pain that increased as the day went on and with use. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with prednisone, advil 800 mg, every 4 hours and tylenol 1000mg in between. The clinical outcome of the events right arm pain in lymph nodes in underarm, pain radiating from shoulder to fingers, fingers numb and tingling, pain on right side of body below shoulder and right arm pain was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
51 2021-07-29 pain in extremity Extreme tiredness/fatigue; Sleeping double; Painful neck; Felt like cold coming on; Rash on right ar... Read more
Extreme tiredness/fatigue; Sleeping double; Painful neck; Felt like cold coming on; Rash on right arm; Headache/Painful back of head; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep6955) via an unspecified route of administration in the arm right on 27Mar2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN), airborne gummies and vitamin D3 (MANUFACTURER UNKNOWN) for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021, patient was shot in right arm and experienced sore arm. On 28Mar2021, the patient experienced rash (in past few days) a weird rash was appearing in random areas for a day, rash on right arm/rash on lower back, arms, legs, torso, chest, feet and headache/painful back of head. On 29Mar2021 at 12:00, the patient felt like cold coming on. On 30Mar2021, the patient experienced painful neck, experienced sleeping double what she usually sleeps (16 hours instead of 8 hours) and extreme tiredness/fatigue. The event resulted in emergency room/department or urgent care. On 05Apr2021, the patient went to urgent care, they even thought she had caught COVID at the same time as getting the vaccine and checked with nasal swab test but the test came back negative. Therapeutic measures were taken as a result of neck pain which included treatment with ketorolac (MANUFACTURER UNKNOWN). The clinical outcome of the event sore arm, rash on right arm/rash on lower back, arms, legs, torso, chest, feet, felt like cold coming on, headache/painful back of head, painful neck, sleeping double and extreme tiredness/fatigue was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
51 2021-07-29 tremor, weakness Shaking; heart pounding; weak; like an adrenaline rush, comes in waves; This is a spontaneous report... Read more
Shaking; heart pounding; weak; like an adrenaline rush, comes in waves; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0179) via an unspecified route of administration, administered in arm left on 17May2021 15:00 (at the age of 51-year-old) at dose 2, single for covid-19 immunisation. Medical history was not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included montelukast (MONTELUKAST); Albuterol inhaler (ALBUTEROL [SALBUTAMOL]) (list of any other medications the patient received within 2 weeks of vaccination). On an unspecified date the patient experienced shaking, heart, weak, like an adrenaline rush, comes in waves. Reported Event: Shaking, heart pounding, weak, like an adrenaline rush, comes in waves. Hard at first and scary. Both times, with the shot. First time it happened two days after the shot. Second time it happened in 2 minutes. First time I went to the ER, this time I did not. Lot EW0179. Adverse event start date: 17May2021. Patient did not receive treatment for the adverse events. Outcome of the events was resolving. Information on the lot/batch number has been requested. Follow-up (19Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
51 2021-07-29 tremor, numbness shaking; sweating; numbness in legs; Liver enzymes high; shortness of breath; Headache; vomiting; Th... Read more
shaking; sweating; numbness in legs; Liver enzymes high; shortness of breath; Headache; vomiting; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 13:30 (at the age of 51years) as dose 1, single for Covid-19 immunization. Medical history included high blood pressure, CRPS (complex regional pain syndrome), fibromyalgia, migraines, osteoarthritis, and known allergies: most antidepressants, arthritis meds. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL) and pantoprazole (PANTOPRAZOLE); both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 (15:30), the patient experienced headache, vomiting, shaking, sweating, numbness in legs, shortness of breath, liver enzymes high. The patient had 2 trips to ER (Emergency room) and numerous tests. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was treated with IV's (intravenous-as reported) and vomiting medications so far. The patient had a Covid test post vaccination. Covid test type post vaccination: Nasal Swab on 20Mar2021. Covid test result: Negative; Covid test date:03Apr2021; Covid test type post vaccination: Nasal Swab; Covid test result: Negative. The outcome of events was not recovered.
52 2020-12-31 discomfort Tinnitus, worse in left ear. Heavy feeling all over. Headache, Tylenol 500mg q6h.
52 2020-12-31 flushing, speech disorder Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my thr... Read more
Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my throat. I was taken to the ER. The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea and feeling very unwell.
52 2020-12-31 numbness, discomfort 10MINS AFTER THE VACCINATION LEFT SIDED FACIAL NUMBNESS . HIGH B/P 172/112 O2 SAT 98% HR 72, RR18. ... Read more
10MINS AFTER THE VACCINATION LEFT SIDED FACIAL NUMBNESS . HIGH B/P 172/112 O2 SAT 98% HR 72, RR18. ANXIETY. SMILE SYMETRICAL PROTRUDING TOUNG CENTERED. @10:45AM B/P 153/93 @10:58 AM B/P 146/89 @11:15AM EMERGENCY SERVICES WERE OFFERED SEVERAL TIMES BY RPH ( PATIENT REFUSED) . PCP WAS NOTIFIED BY FNP - B C . MEDICAL DIRECTOR DR SPOKE TO PATIENT OVER THE PHONE DIRECTLY. NO PARLYSIS WAS DETERMINED. PATIENT COULD FEEL A PINCH IN THE AFFECTED AREA. PATIENT STATED THE REACTION ABATED BEFORE THE END OF THE CLINIC @12:30PM
52 2021-01-03 difficulty speaking Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to b... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate. Patient answered "no" to questionnaire about allergic reactions prior to vaccination. 11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine. Patient brought to ICU for monitoring. Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558 with macular papular rash on leg, chest and back with itching on eyelids and face. No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.
52 2021-01-03 facial paralysis 52 year old female received the Pfizer vaccine on 30 Dec 2020. Noticed a slight left sided facial dr... Read more
52 year old female received the Pfizer vaccine on 30 Dec 2020. Noticed a slight left sided facial droop as left lower lip numbess on 31 Dec 2020, which has become more pronounced over the past 2 days. She states she spoke to the nurse hotline right before speaking to me who told her to go to the ED (she was on her way). Denies any extremity weakness, numbness, HA or dizziness. No pain to face or ear. Speech clear on the phone. No recent illness or history of Bell's palsy. NKDA or any prior adverse reactions to immunizations.
52 2021-01-03 muscle spasms, pain in extremity Arm pain, extreme fatigue, muscle spasm (charley horse) in left inner thigh, shin and foot.
52 2021-01-03 pain in extremity Arm soreness Arm swelling Headache Right side neck pain Bumps on both cheeks (face)
52 2021-01-03 pain in extremity Initially I had sore arm and very tired , which all resolved with in 24 hours of the vaccine. The... Read more
Initially I had sore arm and very tired , which all resolved with in 24 hours of the vaccine. The morning of the 26th (day 3 after vaccine) , I woke up and felt great.. I took my normal 4- 5 mile run. I felt a little dizzy , & hungry when I ran (not my normal) , got home had diarrhea 1 x , then for next two days very faint GI discomfort and I had fever for two days , temp range 99-100
52 2021-01-04 weakness Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see prov... Read more
Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see provider and CXR and EKG normal. States low-grade fever lasted couple of days.
52 2021-01-04 cold sweat Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and c... Read more
Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and clammy. Felt like heart racing. Dizzy. Radial pulse 88 and regular. BP 116/72. Patient declined going to the Emergency Department and was observed for approximately another 30 min, Chest discomfort subsided. Her husband ( an MD) came in and took her to his office for further observation.
52 2021-01-04 facial paralysis Droopy left cheek.; This is a spontaneous report from a contactable nurse. A 52-year-old female pati... Read more
Droopy left cheek.; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), intramuscularly in the left arm, on 17Dec2020 at 14:30 (at the age of 52-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient had no other medications within two weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took sulfamethoxazole, trimethoprim (SEPTRA) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced droopy left cheek on 21Dec2020. No therapeutic measures were taken as a result of the event. The clinical outcome of droopy left cheek was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of droopy left cheek might not be excluded considering the plausible temporal relationship. The patient had previous allergy reaction to antibiotic (sulfamethoxazole, trimethoprim) use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-01-04 feeling hot, cold sweat 1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received... Read more
1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received COVID POC test and was negative. Left to go home and had loose stool then chills, body aches, hot spells, and extremely tired. Could not stay awake and was in brain fog. Slept all day, all night and all day on 1/5/21. No appetite, stuffy nose, headache, chills and hot spells, no fever, Again unable to stay awake.
52 2021-01-04 flushing, feeling hot Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toe... Read more
Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if I was given IV contrast Dye; Thirst; Hunger; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular at left arm on 17Dec2020 04:30 PM at single dose for COVID-19 immunization. The facility type of vaccine was hospital. Medical history included diabetes, HTN, vertigo, sleep apnea, colonic diverticulitis, fibroid uterus, left cystic breast; pulmonary valve prolapse. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included atorvastatin; metformin; eplerenone; HCTZ; levonorgestrel (MIRENA); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (BEROCCA) for supplement; montelukast sodium (SINGULAIR); loratadine (CLARITIN). No other vaccine in four weeks. On 17Dec2020, patient experienced palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if being given IV contrast dye; thirst; hunger. No treatment for events. It was reported as non-serious. Outcome of events was recovered.
52 2021-01-04 numbness, tingling intermittent numbness and tingling L arm. Sometimes radiating to my hand.; intermittent numbness and... Read more
intermittent numbness and tingling L arm. Sometimes radiating to my hand.; intermittent numbness and tingling L arm. Sometimes radiating to my hand.; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient, not pregnant, received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer BIONTECH Covid-19 vaccine, lot EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 21Dec2020 11:15, single dose (dose 1) for Covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and had drug allergy. Approximately 4days after injection (25Dec2020), the patient started having intermittent numbness and tingling in left arm that sometimes radiating to her hand. She reported that she still have these symptoms as of today. No treatment was given. The outcome of the events was not recovered.
52 2021-01-04 numbness About a half hour after receiving the vaccine I started feeling a numbness under my right eye that p... Read more
About a half hour after receiving the vaccine I started feeling a numbness under my right eye that progressed slowly progressed to around my right eye, cheek, ear and upper right side of my teeth. I was able to move my muscles (no crooked smile) and close my eyes completely. Today I still have this strange feeling but it's very subtle. This hasn't worsened at all since yesterday but hasn't gone away either.
52 2021-01-04 pain in extremity Nausea, lightheadedness, headache, fatigue, sore/swollen arm
52 2021-01-05 weakness Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER ... Read more
Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER for IV fluids and oral Tylenol.
52 2021-01-05 cold sweat Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in ... Read more
Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in supine position Observation maintained until vitals returned to normal
52 2021-01-05 night sweats Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, n... Read more
Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
52 2021-01-05 pain in extremity Headache; Sore arm; This is a spontaneous report from a contactable other healthcare professional (p... Read more
Headache; Sore arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) via an unspecified route of administration on 30Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol and asthma. Concomitant medication included cetirizine hydrochloride (ZYRTEC), hctz (HCTZ), metoprolol succinate (TOPROL XL), omeprazole (OMEPRAZOLE) and pravastatin (PRAVASTATIN). The patient previously took diphenhydramine (BENADRYL) and experienced drug allergy. The patient experienced headache and sore arm on 30Dec2020 13:00. Outcome of events was recovering.
52 2021-01-05 pain in extremity the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; t... Read more
the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; top of her stomach had a bad burning sensation; Vomiting; she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing; sore throat with a mild cough, like she needed to be clearing her throat; sore throat with a mild cough, like she needed to be clearing her throat; got a chill; food was not tasting right; arm was sore; could not raise her arm; her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unspecified route of administration on 21Dec2020 on left upper arm at a single dose for COVID-19 prevention. Current medical history included a lung disease called asthma and allergies, diagnosed in her late 20's; Diabetes Type 2, diagnosed about 10 years ago and High Blood pressure, diagnosed when she was in her 30's. Caller also wanted to include that she did have COVID before, she had COVID in Jul2020. Current concomitant medications included salbutamol (ALBUTEROL) at 2 Puffs via inhalation, twice daily for asthma; Unspecified Blood Pressure Medication One pill, once daily by mouth in the morning; Unspecified Nasal Spray 1 spray in each nare, once daily via nasal inhalation; montelukast sodium (SINGULAIR) at 1 pill via oral, once a day for allergies; metformin at 1 pill, daily, by mouth for Diabetes Type 2. The patient stated that her place of employment did not give her the card that has the lot number on it, they said they would give it to her with her second injection. The patient did not know the dose received, just that it was the first in the series. The patient had no other vaccines on the same day as the COVID vaccine. The patient reported that her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds. The patient received the vaccine on 21Dec2020, and as soon as she got the shot, her arm was sore like a flu shot. When she got the shot, she could not raise her arm past her shoulder without pain, but now she can raise her arm again. On Thursday, 24Dec2020, patient got a chill, and later that same night, food was not tasting right. On 25Dec2020, the chill continued, and she had a little bit of a sore throat with a mild cough, like she needed to be clearing her throat. On 26Dec2020 morning, the patient experienced vomiting when she woke up, and the top of her stomach had a bad burning sensation, and she had diarrhea. The patient stated that while she was vomiting, she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing. But the patient stated that she vomited, had diarrhea, and the burning sensation, the whole day on Saturday. The patient stated that on 27Dec2020, it calmed down, and she did not vomit at all. The patient stated that she felt like she needed to vomit, but she did not. The patient states that on Sunday, she still had the chills a little, and the top part of her stomach was still burning. The patient took some Pepto-Bismol and that helped calm down the caller's stomach. The patient stated that she could feel the Pepto-Bismol cooling her stomach off, like it had been hot, and patient stated that the top of her stomach felt swollen and gassy. The patient stated that later Sunday night, things calmed down, but she still has the burning sensation and she did not feel like she needed to vomit anymore. This morning, patient reported that she still has some burning sensation, but now, it is coming and going like labor pains. The patient stated that she did go to the bathroom once this morning and had diarrhea that was like liquid-y water. The patient stated that during all this over the last few days, each and every time that she tried to eat, she couldn't eat much because her stomach would burn more with eating. But yesterday, the patient had some fried fish and stated that the fried fish did not burn as much as the rest of the food she tried eating. The outcome of the events vomiting and the top of her stomach felt swollen and gassy was recovered on 27Dec2020, arm was sore and could not raise her arm was recovered on 26Dec2020, chills, top of her stomach had a bad burning sensation was recovering, Diarrhea/had diarrhea that was like liquid-y water was not recovered and other events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vomiting and Foreign body aspiration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-01-05 tingling Right shoulder (injection site), right back, HA 12/24/20-12/27/20. Right-sided back tingling on star... Read more
Right shoulder (injection site), right back, HA 12/24/20-12/27/20. Right-sided back tingling on starting 12/24/20. Fatigue and chills 12/28/20. Occasional right back tingling resolved 12/31/20.
52 2021-01-05 tremor, numbness, tingling Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated p... Read more
Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated pupils), loss of BP, rapid heart rate, uncontrollable rigors/trembling. Rushed down hall to ED via stretcher. Received IV fluids, IV steroids, IV benedryl, IV pepcid, IV ativan.
52 2021-01-06 weakness Temperature 103.1, chills, muscle and joint pain, fatigue, weakness dizziness, headache, nausea rest... Read more
Temperature 103.1, chills, muscle and joint pain, fatigue, weakness dizziness, headache, nausea rest and fluids, acetaminophen started at 0400 am on 1/6 symptoms started to resolve by 2000 (8pm) on 1/6
52 2021-01-06 numbness Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was t... Read more
Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was tingling and felt numb. I continued to close up my desk to leave work for the day thinking it would just go away in few minutes. When I got to my vehicle I took two Benadryl capsules and drank a bottle of water and waited nearby the hospital emergency department parking area for 30 - 40 minutes. The numbness had eased and I drove home. Tuesday and today (Wednesday) I have felt very tired and fatigued.
52 2021-01-06 numbness Diarrhea numbness of face/tongue Narrative:
52 2021-01-06 pain in extremity 12/22 vaccination. Felt fine. Arm sore 12 hours 12/26 - sudden sharp pain in chest, palpitations. H... Read more
12/22 vaccination. Felt fine. Arm sore 12 hours 12/26 - sudden sharp pain in chest, palpitations. HR irregular. waiting 15 min. Went to the ER. Frequent PVCs; occasionally over the years. Discharged home. Not sure if related to vaccine as under a lot of stress.
52 2021-01-07 weakness, feeling hot SEVERE FATIGUE AND WEAKNESS, LEFT AXILLARY PAIN AND EDEMA, HOT TO TOUCH, SINCE 1/8/2021 UNABLE TO GO... Read more
SEVERE FATIGUE AND WEAKNESS, LEFT AXILLARY PAIN AND EDEMA, HOT TO TOUCH, SINCE 1/8/2021 UNABLE TO GO TO WORK DUE TO SYMPTOMS
52 2021-01-07 weakness Chills, vomiting, fever 104, upset stomach, low energy level, headache
52 2021-01-07 weakness LEFT AXILLARY PAIN AND EDEMA, GENERALIZED WEAKNESS AND MUSCLE PAIN WAS UNABLE TO GET OUT OF BED
52 2021-01-07 weakness HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSE... Read more
HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSEA AND VOMITING STOPPED ON 1-2-21 BUT RETURNED ON 1-8-21.
52 2021-01-07 burning sensation Temp 102.3 ,Severe headache, whole body muscle aches, felt like I was on fire from the inside out.
52 2021-01-07 feeling cold, tremor Chills; Shaking; Patient was bad and cold; This is a spontaneous report from a contactable consumer ... Read more
Chills; Shaking; Patient was bad and cold; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231, Expiration Date: 30Apr2021), via an unspecified route of administration in left arm, on 31Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included blood pressure. The patient had unspecified concomitant medications. The patient took this shot on 31Dec2020 at her job at medical center (EDF, environmental service; it's housekeeping). The patient was fine during the daytime. The patient made it to her home and now she got the chills and was shaking on an unspecified date. When the patient was asleep, that is when she started feeling chills and the shake. The patient was bad and cold, and she got a bad chill. The patient wanted to report and asked if it was going to go away. No treatment was administered for the events. The outcome of the events was unknown.
52 2021-01-07 feeling hot Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins ... Read more
Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins & then returned to work. on 12/30/2020 patient was at work in Presurgical testing dept & experienced near syncope, dizziness & elevated BP. reported to ED & was admitted to telemetry unit.
52 2021-01-07 numbness After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mout... Read more
After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mouth. My bones hurt, and my neck hurt really bad. that lasted for three days. I developed chills and a fever, I felt really sick. I had a COVID test and was positive.
52 2021-01-07 numbness Mid back pain, Right hip numbness, macular rash on administered arm
52 2021-01-07 pain in extremity, weakness, cold sweat, feeling hot Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Ski... Read more
Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Skin is sore from the fever. Headache, temp 100.3. Weak and loopy, slept all day. Hurts under the arm. SOB.
52 2021-01-07 pain in extremity 12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., i... Read more
12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., itching (Brazo caliente)
52 2021-01-07 tremor, muscle twitching, muscle spasms muscle spasming; muscle spasming or twitching; shaking; my muscles are weak; This is a spontaneous r... Read more
muscle spasming; muscle spasming or twitching; shaking; my muscles are weak; This is a spontaneous report from a contactable nurse (reporting for herself). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685) via an unspecified route of administration, on 20Dec2020, single dose for COVID-19 immunization. Relevant medical history was none. Concomitant medications were not reported. The patient started having like muscle spasming or twitching and like shaking a little bit like her muscles were weak on an unspecified date. Outcome of the events were unknown.
52 2021-01-08 feeling hot after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofra... Read more
after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofran 4mg, gave one dose epi-pen, and 50mg Benadryl. patient still complained of chest pain and was dry heaving. she was then transported by ems to the hospital at 4pm.
52 2021-01-08 flushing ErythemaMultiform PT COMPLAINS OF FLUSHING; CHEST/NECK/FACE/EARS REDDENED; VS: P-126; R-16; BP-158... Read more
ErythemaMultiform PT COMPLAINS OF FLUSHING; CHEST/NECK/FACE/EARS REDDENED; VS: P-126; R-16; BP-158/98;SAT-100%; DOCTOR AT BEDSIDE TO EVALUATE PT. 1300- NO REPIRATORY DISTRESS;VS- 143/83;104; 100%; 16; MD ADVISED PT TO TAKE 25-50MG OF BENADRYL EVERY 6 HRS FOR 24 HR Narrative: PATIENT WITH FLUSHED SKIN; VSS; DENIES DIFFICULTY BREATHING; ADVISED BY DOCTOR TO TAKE 25-50MG BENADRYL EVERY 6HRS AND FOLLOW UP IF ANY CHANGE IN OR WORSENING OF SYMPTOMS. AMBULATED FROM ROOM WITH HUSBAND. NO ASSISTANCE NEEDED.
52 2021-01-08 flushing ErythemaMultiform Pt complains of flushing; chest/neck/face/ears reddened; VS: P-126; R-16; BP-158/9... Read more
ErythemaMultiform Pt complains of flushing; chest/neck/face/ears reddened; VS: P-126; R-16; BP-158/98;SAT-100%; Dr at bedside to evaluate pt. 1300- No repiratory distress;VS- 143/83; 104; 100%; 16; MD advised pt to take 25-50mg of benadryl every 6 hrs for 24 hr Narrative: Patient with flushed skin; VSS; denies difficulty breathing; advised by Dr to take 25-50mg benadryl every 6hrs and follow up if any change in or worsening of symptoms. Ambulated from clinic with husband. No assistance needed.
52 2021-01-08 pain in extremity, night sweats, pain in extremity, night sweats Headache, Myalgia, Fever, chills, arm pain, nausea, cough, fatigue, night sweats
52 2021-01-08 tingling, muscle spasms HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after r... Read more
HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after receiving the vaccine she felt uneasy and experienced the sensation of throat tightness and numbness and tingling in hands and feet, also some rigidity/clonus in the hands. No rash, no wheezing, O2 sat 99%+. The team at the vaccination clinic checked her vital signs and her systolic BP was elevated to 220's. A rapid response was called and she was taken to the emergency room. In the emergency room, she received a neurology consult and head CT to rule out hypertensive bleeding. The scan was negative. She was given labetalol 10mg IV to lower BP, and also solumedrol 125mg, benadryl 25mg. No epinephrine given. Serum potassium was found to be low as well; given oral potassium repletion. Discharged from ER by noon same day, BP down to 160/79.
52 2021-01-09 feeling hot, pain in extremity Extreme fatigue on Friday during the day, by 5pm I was running a low grade fever through the night t... Read more
Extreme fatigue on Friday during the day, by 5pm I was running a low grade fever through the night that was 100.9 . Body aches, cold, headache, dizziness. Saturday ran fever off and on that never got above 100.9. Which broke Sunday am. Sunday just fatigue, sore arm that is warm to the touch, but not red.
52 2021-01-09 pain in extremity Extreme fatigue, muscle aches, slight fever (99.0) and right arm soreness
52 2021-01-10 inability to speak Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortn... Read more
Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortness of breath that night. Next day still had fever, severe body aches and cough got worse with shortness of breath. I did home nebulizer several times and started prednisone 40mg. 1/6/21 shortness of breath worsened to the point I couldn't talk, chest tightness with burning. Went into ED at hospital where they gave me another breathing treatment x 2, magnesium sulfate, IV solu medrol. They were going to admit me but I decided against it with all the covid patients.
52 2021-01-10 weakness Approximately 5 minutes after receiving the vaccine patient began to feel very weak and drained and ... Read more
Approximately 5 minutes after receiving the vaccine patient began to feel very weak and drained and sleepy. Arms felt weak. Pain in the back of the neck. At 3:05pm, BP 155/88 HR=66 Temp 98.4F O2=95% Glucose=160. Patient reports taking Tylenol prior to receiving the vaccine. At 3:10pm, BP=148/95 HR=68, O2=95%. Patient was released from clinic at 3:17pm. Patient reports having similar symptoms following 1st dose of Pfizer Covid-19 vaccine occurring 1 hour after receiving the dose. Patient reports being very sleepy and fatigued. Fatigue lasted for 3 days. Per patient, symptoms resolved with Tylenol and rest.
52 2021-01-10 flushing 52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccin... Read more
52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.
52 2021-01-10 migraine Migraine headache began the next morning about 7am and increased as the day progressed including nau... Read more
Migraine headache began the next morning about 7am and increased as the day progressed including nausea and light sensitivity. Waves of nausea and headache continued into the next day. I had not had a migraine in over 2 years prior to this event. Treated with OTC Excedrin at first on Jan 10th, then when that was ineffective took butabital at lunch time and when that was ineffective took Maxalt with phenergan about 5p. The next day on Jan 11th, thought I was better but by 630a nausea returned in waves and headache began building again. Took Maxalt with phenergan about 930a and again at 9p.
52 2021-01-10 pain in extremity sore arm after the first 6-8 hours that lasted maybe 8 hours. At approx. 30 hours post vaccination,... Read more
sore arm after the first 6-8 hours that lasted maybe 8 hours. At approx. 30 hours post vaccination, woke with fever, chills, rigors; took Tylenol and Benadryl and symptoms subsided after about 3 hours.
52 2021-01-10 pain in extremity One week after first vaccine, sudden onset - with no trauma or new medications or other known provoc... Read more
One week after first vaccine, sudden onset - with no trauma or new medications or other known provocation developed significant pain at tendons- bilateral symmetrical - hands, wrists, elbows, neck, hips, knees, bottoms of feet
52 2021-01-10 tingling Went into the ED for bilateral hand and feet tingling. Worked up for possible Guillain Barre.
52 2021-01-10 tremor ABOUT 10 HOURS AFTER SHOT RECEIVED I STARTED SHAKING VIGOUROUSLY AND DID NOT STOP FOR ALMOST 2 HOURS... Read more
ABOUT 10 HOURS AFTER SHOT RECEIVED I STARTED SHAKING VIGOUROUSLY AND DID NOT STOP FOR ALMOST 2 HOURS. THEN I DEVELOPED A SLIGHT FEVER - 100-101 - BAD HEADACHE, MUSCLE ACHES, BODY ACHES. TOOK TYLENOL REGULARLY, FINALLY EXCEDRIN FOR HEADACHE AND ICE PACKS FOR BACK OF NECK AND FOREHEAD. DIBILATING FOR THE NEXT DAY, THEN FEVER BROKE AND FELT BACK TO NORMAL.
52 2021-01-10 tremor Shaking chills, fever, severe headache, joint pain and body aches limited my ability to work Start... Read more
Shaking chills, fever, severe headache, joint pain and body aches limited my ability to work Started 12 hours after second dose of covid vaccine. No reaction to first dose.
52 2021-01-11 hypersensitivity of all senses, tingling, burning sensation injection itself into L deltoid was not painful. 5-10 minutes after injection I experienced sharp ti... Read more
injection itself into L deltoid was not painful. 5-10 minutes after injection I experienced sharp tingling/burning over the medial clavicle and extending into the neck. there was no rash, redness, swelling, swallowing or breathing difficulty. At 21 days, I am still experiencing hyperaesthesia and some tingling over the medial clavicle, and a zinging sensation over the clavicle/sternoclavicular joint with L shoulder movement, valsalva or burping. evaluation on site by vaccine provider. telephone consultation with PCP 2 days and 1 week later, and brief telephone consultation with local allergist. gabapentin for discomfort
52 2021-01-11 numbness Numb cheeks, lips & tongue. Minor swelling of lips. Approx. 40 minutes post injection while driving ... Read more
Numb cheeks, lips & tongue. Minor swelling of lips. Approx. 40 minutes post injection while driving home. Took 1 benadryl when I got home and all symptoms subsided approx 30 minutes later.
52 2021-01-11 tingling, cold extremities Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eye... Read more
Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eyes swelled. Significant scleral edema bilaterally but mostly left eye. Sudden chills and felt freezing in extremities. Face became tingly. Took 50 mg Benadryl, Claritin and rescue inhaler (2 puffs albuterol). Within 1.5 hours felt better and able to rest. Still Itchy but wheezing was better. On 1/12 woke with swollen eyes. Took 25 Benadryl and Claritin. Walked 1 mile and began to wheeze. Took albuterol and rested.
52 2021-01-11 cold extremities, feeling cold, cold sweat, flushing, feeling hot Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated sh... Read more
Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated she was hot and her hands were sweaty. after 15 minutes post injection patient was red going down her neck. She was then evaluated by the EMTs. She stated she felt a little better by 9:45 but we continued to observe. By 10:05 patient was still flushed and was getting cold hand . Gave Benadryl 25 mg po at 10:17 AM. By 1035 Patient was very cold but her face was still flushed and felt hot to her. Her hands were clammy and cold. EMT transported to hospital at 10:45. This was her second dose of Pfizer.
52 2021-01-12 burning sensation Dizzy, cloudy, burning sensation of right side of neck. BP is ordinarily 11/62, but was 135/85. Obse... Read more
Dizzy, cloudy, burning sensation of right side of neck. BP is ordinarily 11/62, but was 135/85. Observed, issues resolved at 12:46 pm/
52 2021-01-12 flushing dizziness with perceived palpitations; facial flushing and headache
52 2021-01-12 numbness At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Use... Read more
At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Used medication for asthma. Flovent inhaler for 5 times. Used xyzal 5mgs via oral. These medications are used by doctor's orders.
52 2021-01-12 pain in extremity Patient reports arm and leg pain (aching), extreme pain along with chills and low grade fever, mild ... Read more
Patient reports arm and leg pain (aching), extreme pain along with chills and low grade fever, mild headache.
52 2021-01-13 facial pain, numbness, pain in extremity PFIZER-BIONTECH COVID 19 VACCINE EVA Soreness in arm, up neck and into face/temple/cheek and jaw on ... Read more
PFIZER-BIONTECH COVID 19 VACCINE EVA Soreness in arm, up neck and into face/temple/cheek and jaw on injection side. Face /cheek feels sore, swollen and numb- coming from neck, into face, up to temple/forehand, into cheek and jawline. Is this possible Bells Palsy ?
52 2021-01-13 numbness Received COVID vaccine on 1/7/2021 on 1/10/2021 I had a sudden onset of right side facial numbness.... Read more
Received COVID vaccine on 1/7/2021 on 1/10/2021 I had a sudden onset of right side facial numbness. I was worked up in the ER for a possible stroke but all testing was negative. The numbness lasted 3 days and has now resolved. My COVID shot was given in the right arm.
52 2021-01-13 pain in extremity Received 2nd dose Pfizer lot EL0142 on 1-13-2021 on right arm. Has body aches, joint pain, muscle a... Read more
Received 2nd dose Pfizer lot EL0142 on 1-13-2021 on right arm. Has body aches, joint pain, muscle ache, head ache, fatigue, and arm pain.
52 2021-01-13 pain in extremity Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/... Read more
Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/29 around noon she started feeling tachycardic (resting heart rate was 107-125 bpm). She vomited and felt anxious. Developed fever of 101.8 and was very achy. Day 2: low grade fever treated with ibuprofen. Day 3: fever free but dizzy feeling. Day 4: symptoms resolved. Of note, patient was 30 days out from having had COVID-19 at the time of vaccination. Patient states her course of COVID was "serious" but did not require hospitalization.
52 2021-01-14 difficulty speaking 1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor ... Read more
1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor as she was anxious prior to receiving vaccine 1444 states sxs are getting worse, still no swelling or SOB noted 1445 States she now feels like tongue is swelling and lump in throat is worse, cough noted. 99.5F, 97% RA, 102HR, 22 Resp, 146/99 BP 1448 Hoarseness in voice noted as associate getting into wheelchair 1449 Turn over care to ED
52 2021-01-14 muscle spasms Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of b... Read more
Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of both of my hands with itching and warm redness in them both (I have pictures) Within an hour it began feverish red itching and slight burning on both of The undersides of my forearms. I was advised by the pharmacists on duty in the covid clinic site to use topical Benadryl cream and or take Benadryl by mouth if it worsened. I was told to seek emergency dept help if any signs of breathing issues presented. The next morning the itching was gone the redness subsided and the rash was markedly better but still raised in the tops of my hands. By 1030am on 1/12/21, I could not detect taste or smell at all. I was advised then to report to employee healthline for further instruction. I was told to leave work and proceed to our employee Covid swab testing drive thru facility for Covid testing and remain home for results the following morning on 1/13/21. At approximately 10am 1/13/21 I was confirmed positive for COVID-19 via the swab results. I was told to quarantine and given a return to work date of 1/24/21 as long as my symptoms were resolved. I am currently in home quarantine still suffering no taste or smell, muscle cramps in legs, thighs and back. Fatigue, Loss of appetite, sinus pressure and headache not relieved with medications.
52 2021-01-14 pain in extremity neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder a... Read more
neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder and over to right ear; left arm sore; neck sore to left shoulder and over to right ear; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number EK4176, Expiry Date: Mar2021, via an unspecified route of administration on 21Dec2020 at a SINGLE DOSE then via an unspecified route of administration on 07Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband was calling for his wife that had the second shot. He stated that she was a nurse. He stated that she came home from work with her arm and neck sore. He stated that the neck soreness was causing ear ache. He stated that her fever was 102.9 and stated that they put a cool rag on her head. He stated that she had the shot yesterday and stated that she had her first shot 21Dec2020. They stated that arm sore at 1:00 in morning and stated sore neck at 11:30 this morning. Fever started at 11:30 and was 99.7 and about 15 minutes later was 99.9 and stated that was with having three Aleves. She stated that it is back up to 102.9 and stated that the right ear ache started at 11:00am today. The patient underwent lab tests and procedures which included body temperature: 102.9 on 08Jan2021, 99.7 on 08Jan2021 and 99.9 on 08Jan2021. Therapeutic measures were taken as a result of fever (pyrexia). The outcome of events was not recovered.
52 2021-01-14 pain in extremity Nauseous; threw up a little; she keeps falling down, has had 3 falls; hit her head; she has a huge b... Read more
Nauseous; threw up a little; she keeps falling down, has had 3 falls; hit her head; she has a huge bump on her face that is very painful; she cannot walk straight or without assistance anymore; Vertigo; Weakness in the muscles; a little arm soreness; Body aches; Chills; Could not sleep; Fever; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine), Batch/lot number: EK9231, Expiry Date: 31Mar2021, via an unspecified route of administration on 06Jan2021 09:00 at single dose in deltoid right for COVID-19 immunisation. Medical history included heart attack from Jul2019. Concomitant medication included diltiazem from 2019 and ongoing at 120mg tablet taken daily for abnormal heart rhythm she did not know of until had heart attack, acetylsalicylic acid (BABY ASPIRIN) from 2019 and ongoing at 81 mg tablet taken daily for heart attack. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 17Dec2020 for COVID-19 immunisation; she got the Flu vaccine every year and got shingles vaccine in Mar2020 for immunization. She did totally fine after receiving Flu vaccines and the Shingles vaccine. She had no side effects from the Flu vaccines except maybe a little arm soreness; she had arm soreness for a couple of days after the shingles vaccine; maybe a slight fever and took it easy. This Emergency Room Nurse (patient) received her second dose of Pfizer BioNTech COVID-19 Vaccine on 06Jan2021 around 9:00am. She went back to work, worked around 6-8 more hours that day and was fine. She went home and around 8-10 hours after she got the second dose on the evening of 06Jan2021 she had a little arm soreness and body aches. Last night all night she had chills; she could not sleep; fever. This morning: 07Jan2021 she was so nauseous that she got up and tried to get to the bathroom where she threw up a little. She reported as of 07Jan2021 she kept falling down: She fell in the bathroom this morning first when she was trying to get to the bathroom to throw up; During the second fall she was going on the stairs and fell, and hit her head; she had a huge bump on her face that was very painful now that she thought was from that second fall; and she had the third fall this evening; she cannot walk straight or without assistance anymore, she had been on the couch all day. She has had vertigo all day and weakness in the muscles. Chills was described as unbearable, heavy chills that she could not control. Fever: Temperature of 102-102.4 degrees Fahrenheit. The high fever hit around 3:00am on 07Jan2021. When her high fever hit around 3:00am she thought she would go to the emergency room but she did not want to scare her family so she stayed home and tried to pull through it. Today she took a Tylenol after she threw up this morning just to get through the day. Since she cannot walk without assistance or walk straight today that's the only lingering symptom that really worries her; she may go to the emergency room tonight if she did not get any better. She just did not want to scare her family and the emergency room was another copay cost so she really did not want to go to the emergency room at her workplace; but she may go there tonight and be kept overnight under observation. Prior to taking this second dose of Pfizer BioNTech COVID-19 Vaccine she was completely fine. She expected to have body aches, chills and fever; but she never thought the Pfizer BioNTech COVID-19 Vaccine would put her into a place where she is falling like this with the nausea and vertigo; she has never in her life had vertigo or falling like this. She reported she had no other vaccinations on the same date as Pfizer BioNTech Vaccine second dose. Has had no other vaccines in the recent past. She had never felt like this before with any other vaccines; she had never felt so weak in her muscles and never fallen down like this with any other vaccines. Seriousness criteria and outcome of all events unknown. The reporter considered all events were related to Pfizer BioNTech COVID-19 Vaccine.
52 2021-01-14 pain in extremity Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate f... Read more
Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate fatigue, nausea, more severe arm pain than day before; Felt sweaty/chills, neck lymph glands tender; Felt sweaty/chills, neck lymph glands tender; neck lymph glands tender; Moderate arm pain that night; This is a spontaneous report from a contactable Nurse (patient). A 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1284), intramuscularly on 04Jan2021 16:30 at single dose for COVID-19 immunization. Anatomical Located at Arm Right. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication which the patient received within 2 weeks of vaccination included colecalciferol (VITAMIN D), tocopherol (VITAMIN E), magnesium, ibuprofen, paracetamol (TYLENOL). The patient previously took amoxicillin and experienced allergy. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced Moderate arm pain that night on 04Jan2021 19:00 and woke up with moderate fatigue, nausea, more severe arm pain than day before on 05Jan2021. At 23 hours post injection on 05Jan2021, the patient also felt sweaty/chills, neck lymph glands tender. All symptoms gone at 48 hrs post injection. The patient did not receive any treatment for the reported events. The outcome of the events was recovered in Jan2021. This case reported as non-serious.
52 2021-01-14 pain in extremity onset same day of vaccine, c/o chills, no fever, pain in hips and legs and low BP 80/52
52 2021-01-14 tingling 23 minutes after the patient receive the shot she complained of tingling at the site and down her ar... Read more
23 minutes after the patient receive the shot she complained of tingling at the site and down her arm. Provided patient with 2 25mg Benadryl to self administer. Upon checking at 1pm and 7:00pm patient was feeling better.
52 2021-01-14 tingling About 10 min after receiving vaccine, patient began to experience lightheadedness and parethesias of... Read more
About 10 min after receiving vaccine, patient began to experience lightheadedness and parethesias of distal arm. Vital signs within normal limits. Patient improved.
52 2021-01-14 unresponsive to stimuli, grand mal seizure THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL SEIZURE AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD ... Read more
THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL SEIZURE AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD WORK WAS DONE AND CT SCAN. SENT HOME AROUND 6:30 AM ON JAN 1ST. (I DO NOT REMEMBER MUCH JUST WHAT MY FAMILY HAD TOLD ME) . I DO REMEMBER BEING SEVERLY SICK WITH VOMITING IN THE ER. CURRENTLY FOLLOWING UP WITH MY FAMILY MD AND HAVE MRI AND EEG TESTS SCHECULED WITHIN THE NEXT COUPLE OF WEEKS.
52 2021-01-15 tingling 11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms ... Read more
11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms of tingling, warmness, pressure, burning on her upper left chest. Nausea and dizziness 11:58 am - takes diphenhydramine 50mg, (2 capsules of 25mg) by mouth 12:02 pm - receives 1 dose of EpiPen autoinjector 0.3mg IM. 911 call 12:05 pm - reports feelings of tightening in her throat and receives 2nd dose of EpiPen autoinjector 0.3mg IM 12:10 pm - reports that tightening in her throat is relieving 12:15 pm - EMS arrives and is transporting her to the ER
52 2021-01-16 flushing received vaccine at 1330. Observed until 1350. After leaving building, noticed redness/flushing on f... Read more
received vaccine at 1330. Observed until 1350. After leaving building, noticed redness/flushing on face and chest. Came back to building for additional observation at 1400. Given Benadryl and observed.
52 2021-01-17 depressed level of consciousness Patient received the 2nd dose covid 19 vaccine at 12:07 and at approximately 12:10 began to feel nau... Read more
Patient received the 2nd dose covid 19 vaccine at 12:07 and at approximately 12:10 began to feel nauseated. Patient immediately began vomiting copious amounts and had a decreased level of consciousness. Pt was responding to painful stimuli and then after a minute to verbal commands but remained with an altered mental status. HR tachycardia at 118 bpm, pulse oximetry initially 96 on room air. The rapid response team arrived, an IV was established, cardiac monitor placed, Oxygen at 15 lpm via non rebreather mask. Zofran IM given prior to IV being established. Zofran IV given next. Solumedrol given IV. Bolus of Normal Saline given. Patient transported to the emergency department via stretcher.
52 2021-01-17 difficulty speaking Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Ben... Read more
Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Benadryl 1/15 at 9:30pm developed hives on back, stomach, hips and upper thighs,, hands were swollen took 25mg of Benadryl 1/16 at 3am took another 25mg Benadryl hives and itching. 1/16 630am took 25mg Benadryl and Claritin hives and itching improving. 1/16 at 9am all but 2 hives resolved to oatmeal bath and applied hydrocortisone. 1/16 at 630pm felt throat was swelling, voice change, tingling lips and thick tongue took 50 mg of Benadryl went to ER around 730pm. Was given Pepcid and 50mg prednisone in the Emergency Room. 1/16 11pm.Discharged home with prescriptions for prednisone, Benadryl and epi-pen and Pepcid. Continues now with lingering sore throat
52 2021-01-17 flushing Pt. C/O flushing, sweating and feeling feverish, an exaggeration of her reaction to the first vaccin... Read more
Pt. C/O flushing, sweating and feeling feverish, an exaggeration of her reaction to the first vaccine. She denied pain, difficulty breathing or other complaints. She lay down, got a cold compress and felt significantly better
52 2021-01-17 pain in extremity Sore arm Tingling lips
52 2021-01-17 tenderness Headache the next day, chills, low grade fever less than 100.3, body aches, fatigue, pain/soreness u... Read more
Headache the next day, chills, low grade fever less than 100.3, body aches, fatigue, pain/soreness under arm/side of breast.
52 2021-01-18 weakness After having the vaccination, felt woozy, headache. Went to bed, up Sunday morning, about 1:30, 1:45... Read more
After having the vaccination, felt woozy, headache. Went to bed, up Sunday morning, about 1:30, 1:45 had sever headache, feverish, no energy, sick to her stomach. Monday morning, excessive heart rate. Did not go to work. Was pale looking. By Monday evening, felt better. Today, wasn't feeling 100% but did go back to work.
52 2021-01-18 facial pain, pain in extremity, numbness Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side... Read more
Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; Feel numb; Sore-all on same side as injection; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EL3246) , via an unspecified route of administration on 13Jan2021 17:00 at single dose on left arm for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included fluticasone propionate (FLONASE), pantoprazole. The patient experienced arm/neck soreness, travel up neck to side of face/around temple; side of head/face/cheeks/jaw, neck are painful, feel numb, and sore-all on same side as injection; and possible Bells Palsy on 14Jan2021 02:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. No treatment was received for the events. The outcome of the events was not recovered.
52 2021-01-18 numbness constant nausea, extremely fatigued, malaise ever since injection. body aches, chills, numbness i... Read more
constant nausea, extremely fatigued, malaise ever since injection. body aches, chills, numbness in hands all went away but had them for over a week
52 2021-01-18 tingling Severe Headaches, Dizziness & facial tingling 10 minutes after recieving 2nd Covid Vaccine. Transpor... Read more
Severe Headaches, Dizziness & facial tingling 10 minutes after recieving 2nd Covid Vaccine. Transported to ER for further evaluation / treatment
52 2021-01-19 feeling cold DIZZY, CHILLS, FATIGUE
52 2021-01-20 difficulty speaking Patient started getting very hoarse about 1.5 hours after vaccination. When clinic pharmacist questi... Read more
Patient started getting very hoarse about 1.5 hours after vaccination. When clinic pharmacist questioned patient about condition, patient only reported hoarseness and did not report any difficulty breathing or swelling in the throat or face at that time. Pharmacist discussed what to monitor and when patient should seek immediate medical attention. Patient asked if she could take any OTC products. Pharmacist discussed OTC options with patient and re-iterated what to monitor and when patient should seek immediate medical attention.
52 2021-01-20 feeling hot Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left... Read more
Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left anterior chest wall; Underarm and neck with pain; Underarm and neck with pain; Heat; Redness; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686; Expiration date was not reported) on 08Jan2021 (15:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 10Jan2021 (15:00), the patient had severe swelling on the left upper arm and left anterior chest wall; underarm and neck were with pain; was in heat; and had redness. The adverse events resulted in the patient having a visit on the doctor or other healthcare professional office/clinic. The patient had received treatment for the reported adverse events. The outcome of the events, 'severe swelling on the left upper arm and left anterior chest wall', 'underarm and neck were with pain', 'heat' and 'redness', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
52 2021-01-20 flushing The episode came on very quickly. Felt like I was going to pass out. Became very flushed, heart wa... Read more
The episode came on very quickly. Felt like I was going to pass out. Became very flushed, heart was racing and very shaky. I work at a clinic, so my blood pressure was taken and it was 160/100, pulse was 120. Had a bad head ache and continued to have waves of this for about an hour.
52 2021-01-20 flushing 10 min. after vaccine injection: headache, scratchy throat and throat tightening lasting for about 1... Read more
10 min. after vaccine injection: headache, scratchy throat and throat tightening lasting for about 10min and subsided. 50 min. after vaccine injection: flushed, redness in face, ears, and neck progressing to rash on chest, neck. Lasted for about 10min and subsided. Never progressing into full anaphylaxis reaction. No treatment taken.
52 2021-01-20 pain in extremity, muscle spasms Received vaccination #2 1/18/21 at 1000am. Dr. appointment at 1pm. EKG no known abnormalities. 1530 ... Read more
Received vaccination #2 1/18/21 at 1000am. Dr. appointment at 1pm. EKG no known abnormalities. 1530 feet achy R arm where got shot - had muscle spasms in back, Body aches, heart rate 110. 1/19/21-worked 1/19/21 no muscle spasms.
52 2021-01-20 pain in extremity She woke up thinking she didn't sleep; Nausea; sore arm; was really tired; This is a spontaneous rep... Read more
She woke up thinking she didn't sleep; Nausea; sore arm; was really tired; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the right arm on 09Jan2021 at single dose for COVID-19 immunization. The patient had no medical history and there were no concomitant medications. The patient took the first dose of the Covid-19 vaccine and was fine. The lot for the first dose of the vaccine was EH9899. She received it on 19Dec2020 (at the age of 51 years). She took the second dose on Saturday (09Jan2021). She experienced nausea and had a sore arm on 10Jan2021. It was not death defying. She was also really tired on 10Jan2021. She was advised by her employer to report this information. She took some Tylenol and relaxed. She was no longer nauseated or tired. Her arm was not sore only tender. She woke up thinking she didn't sleep on an unspecified date. The patient added that her boss said she might have to be tested. The patient asked if that was something that she needs to do. The outcome of the events nausea and tired was recovered on 11Jan2021. The outcome of the event sore arm was recovering. And the outcome of the event "She woke up thinking she didn't sleep" was unknown.
52 2021-01-21 weakness Vaccine was administered around 4-pm into right arm and bleeding occurred after administration. Aro... Read more
Vaccine was administered around 4-pm into right arm and bleeding occurred after administration. Around 3 am, I awoke with chills and low grade fever. Tmax 103.8F, chills, pressure headache, neck/back pain, and fatigue that lasted ~30 hours. Still have mild pressure headache with mild back/neck pain and weakness.
52 2021-01-21 burning sensation 2 days past vaccination shoulder pain started. Pain is burning and sharp in nature and radiate from ... Read more
2 days past vaccination shoulder pain started. Pain is burning and sharp in nature and radiate from the top of the shoulder to occasionally near the back shoulder blade. Range of motion is affected as it is painful to reach backwards or straight out laterally. Taking 800 mg of Ibuprofen every 6-8 hours to help ease burning sensation. Not always completely helps.
52 2021-01-21 flushing 52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today d... Read more
52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today developed chills and fever. 101.5 now. Also has rash on breast and stomach. Flushed. Headache, nausea and myalgias.
52 2021-01-21 pain in extremity, feeling cold Sore arm started on evening of January 20th (date of injection), 2:00 p.m. January 21st severe body ... Read more
Sore arm started on evening of January 20th (date of injection), 2:00 p.m. January 21st severe body aches, chills and extremely tired. Around 3 a.m. of January 22nd those symptoms where getting better but just below the injection site there is a large red area that is hot and swollen and that is still continuing as of 7:08 p.m. January 22nd
52 2021-01-21 pain in extremity Early morning of January 21st right arm very sore from injection then at 2:00 p.m. January 21st almo... Read more
Early morning of January 21st right arm very sore from injection then at 2:00 p.m. January 21st almost exactly 24 hours after the shot, I started feeling very tired, severe body aches and chills. The next morning on January 22nd about 3:00 a.m. those symptoms where much better BUT down below the injection site is swelled up, red in the size of about a softball and very hot. It is now 5:40 p.m. January 22nd and no improvement with that.
52 2021-01-21 sensory loss, tingling, numbness immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my ... Read more
immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my left arm and into my left jaw. i started to have tingling and loss of sensation to the left side of my face that extended from the left lower eyelid to 4 cm down the left side of jaw, midline to trachea, midline to left nare and radiating to the mid inner left ear canal. I had a burning sensation in the inner left ear canal as well as the left lower lid. Spoke with Dr and was placed on Prednisone 60mg po daily x 10 days with a taper and Valacyclovir 1gm po bid x 10 days. The degree of parenthesis as of 1-22-21 is improved to now encompass from the edge of left nare to the outer canthus of left eye, into the edge of the left ear canal and the edge of the jaw.
52 2021-01-22 tingling paresthesia arms and legs for 2 days following Covid vaccine - Day 3 upper body only (has not gotten... Read more
paresthesia arms and legs for 2 days following Covid vaccine - Day 3 upper body only (has not gotten worse - just a mild tingling sensation) - no pain
52 2021-01-23 pain in extremity After receiving 2nd dose of Pfizer vaccine, within 5 minutes, c/o chest pressure, tachycardia (P=105... Read more
After receiving 2nd dose of Pfizer vaccine, within 5 minutes, c/o chest pressure, tachycardia (P=105) and left arm pain. team was called and was taken to the ER.
52 2021-01-24 weakness Generalized weakness,and muscle/bone aches , slightly dizziness, loss of appetite for 3-4 days
52 2021-01-24 burning sensation headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting 3days. now 17 day later petec... Read more
headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting 3days. now 17 day later petechiae on abdomen abd burning pain (lymph nodes) in right underarm.
52 2021-01-24 feeling hot My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a ... Read more
My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) via an unspecified route of administration at left arm on 12Jan2021 17:00 at single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medication included unspecified medications. The patient previously took hydrocodone bitartrate paracetamol (VICODIN) and experienced known allergies. After approximately 45 minutes after vaccination, her face felt hot and her face and lip were slightly swollen from 12Jan2021 18:00. No treatment received. No other vaccine in four weeks. No COVID tested done post vaccination. The outcome of the events was recovering.
52 2021-01-24 numbness, throat numbness Systemic: Other- numbness/tingling of face and throat and neck; symptoms lasted 1 day
52 2021-01-24 muscle spasms, pain in extremity The evening of injection, started with muscle spasms and aching in deltoid. Over the next day the p... Read more
The evening of injection, started with muscle spasms and aching in deltoid. Over the next day the pain worsened and spread up into my neck, shoulder and down into elbow and forearm. The pain is intense 7/10 and constant. Pain is disrupting my daily activity and sleep. I?ve tried ibuprofen, Tylenol, voltaren gel, lidocaine patches, icy hot, Celebrex, bio freeze, steroid injection, toradol injection, tramadol, multiple massages, hot showers, ice, tens unit, cbd oil. All of these treatments have done very little for the pain
52 2021-01-24 pain in extremity Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and ... Read more
Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and shoulder became swollen; she also has something else going on in her shoulder; achy all over in her neck, arm, and shoulder; achy all over in her neck, arm, and shoulder; Felt sick to her stomach; her arm was sore that evening; This is a spontaneous report from a Pfizer Sponsored Program made from a contactable consumer (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK5730) at single dose on left arm on 23-Dec-2020 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; COPD (chronic obstructive pulmonary disease). Concomitant Medication was nothing new, her normal medication, she took vitamins, and high blood pressure medication. She had had no positive test for Covid prior to the vaccine, she had had no antibody test, she had had no issues with vaccine in the past. The patient experienced left arm swelling in Jan2021 and pneumonia on 08Jan2021. The patient worked in a hospital and received her first dose on 23Dec2020 and she was supposed to get the second dose today but she was not at work today. She was wanting to know if she should go ahead and take the second dose because her arm was still swollen. The product was the Covid vaccine. She stated that her arm was still swollen, when she got shot she was fine, her arm was sore that evening (Dec2020) and then nothing, then a weekend after new years her arm and shoulder became swollen (Jan2021) and she had been to the ER and the doctor thought the swelling was because of the shot, but she also had something else going on in her shoulder (Jan2021). So in the meantime she went to the ER and they took X rays, and they told her that she was starting to develop pneumonia. She was going back to work tomorrow, being that she was on the antibiotics now, still had swelling in the arm, and had pneumonia, should she still get the 2nd shot. She noticed the swelling Saturday after New Years. She was also achy all over in her neck, arm, and shoulder (Jan2021). She felt sick to her stomach, this was all the first Week of Jan2021. She went to the ER, she was not admitted and came home the same day. She went to the ER on 08Jan2021. 08Jan2021 was also when the pneumonia was diagnosed. The name of antibiotic she was prescribed was doxycycline. She started it on Saturday 09Jan2021, she was prescribed 100 mg 2 pills a day for 10 days. When they did the X ray, they said that the pneumonia had showed up, or she was just starting to get pneumonia. Patient stated that she didn't believe because they made a comment about the way she was laying however she had been taking the medication and feeling better. She was schedule for the second dose today. She did reschedule for Friday, and wanted to know if she should still get it. In the ER, they said it could have been a blood clot and so they did a scan to find blood clots but it was negative. The outcome of event pneumonia was resolving; events left arm swelling and shoulder became swollen was not resolved. The outcome of rest evens was unknown..
52 2021-01-24 pain in extremity Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021. Provide... Read more
Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021. Provider informed me I was there on the wrong day but told me she would fit me in so I would not have to come back. After receiving the 2nd dose and waiting the 15 minutes, I realized that the time between shots were 14 days instead of 21. The HCP was contacted and was to reach out to vaccine provider. 1/23/2021 = date of receiving shot = no symptoms 1/24/2021 = 3:10 am woke with 102.1 fever, sore arm, body aches, and my skin hurt. Woke again at 8:00am with fever of 101.3 and the same symptoms. Alternated Tylenol and Ibuprofen every 2 yours. Fever went away around 10:00am but went still had body and skin aches and tired. 1/25/2021 = woke with no fever, but arm still hurt and so does the gland in my armpit. Still have body & skin aches. I am tired and I feel slightly off. My eyes are very tired.
52 2021-01-24 pain in extremity Lump on the left side of neck, pain on the underarm
52 2021-01-24 tremor Shaking/shivering violently for 2 hours; Shaking/shivering violently for 2 hours; Bad headache; Musc... Read more
Shaking/shivering violently for 2 hours; Shaking/shivering violently for 2 hours; Bad headache; Muscle aches; Fever finally broke at 3pm on the next day 17 hours after symptoms began; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular on the left arm on 09Jan2021 at 11:00, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the left arm on 22Dec2020 at 11:00 for COVID-19 immunization. On 09Jan2021, the patient had shot at 11am with no reaction then at 10pm when started shaking/shivering violently for 2 hours and then developed very bad headache, muscle aches. The patient's fever up to 101 then the fever finally broke at 3pm on the next day (10Jan2021) 17 hours after symptoms began. As treatment, patient took Tylenol and Excedrin for headache, muscles aches and fever. No treatment was reported for the events shaking/shivering. The outcome of the event fever was recovered on 10Jan2021 15:00 while the rest of the events was recovered on Jan2021.
52 2021-01-25 weakness had fever max 100.8; chills; severe body aches; headaches; weakness; fatigue; This is a spontaneous ... Read more
had fever max 100.8; chills; severe body aches; headaches; weakness; fatigue; This is a spontaneous report from a contactable other hcp (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 4176), via an unspecified route of administration on the left arm on 12Jan2021 13:15 at a single dose for covid-19 immunisation. Medical history included PCN allergy from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications included multivitamins, vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and fish oil (FISH OIL). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685) on 22Dec2020 13:00 on the left arm for covid-19 immunization and stated that had no issues after first vaccination. On 12Jan2021 21:00, the patient had fever max 100.8 (no unit reported), chills, severe body aches, headaches, weakness, and fatigue. The patient underwent lab tests and procedures which included body temperature: max 100.8 (no unit reported) on 12Jan2021 21:00. As treatment, patient received OTC NSAIDS. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
52 2021-01-25 numbness I received the Covid-19 vaccine at noon today and at 7:30 pm I began having significant bilateral fa... Read more
I received the Covid-19 vaccine at noon today and at 7:30 pm I began having significant bilateral facial numbness, left side greater than right side with lower lip numbness greater than upper lip numbness.
52 2021-01-25 pain in extremity fever chills body aches nausea headache arm pain
52 2021-01-26 burning sensation 1/20: spot on back burning, right side only. 1/21: chest pain from burning 1/22: Lyrica and Valcyclo... Read more
1/20: spot on back burning, right side only. 1/21: chest pain from burning 1/22: Lyrica and Valcyclovir started, spread to other dermotones. 1/23: burning face/arms. was seen by PCP 1/25: burning on other arm, right. Seen by provider in ED at place of work.
52 2021-01-26 cold sweat, numbness, hot flush Face swelling and numbness, lightheaded, hot flashes with cold clammy skin
52 2021-01-26 facial paralysis facial droop Left
52 2021-01-26 feeling hot Swollen arm, redness, hot Headache Chills Body aches Runny nose Sneezing
52 2021-01-27 weakness After leaving injection center (after waiting 15 min) while driving down the road started getting th... Read more
After leaving injection center (after waiting 15 min) while driving down the road started getting the feeling of my throat swelling. This progressed and got very light headed and weak for about 2 minutes. Throat tightness continued for about 1 hour but did not cause trouble breathing. At one point felt like I was unable to swallow. Monitored by coworkers when arrived at work and chose not to go to ED unless symptoms worsened which they did not.
52 2021-01-27 feeling hot, flushing Customer received SECOND dose of COVID-19 vaccine at 0910 in medical center and transferred to post ... Read more
Customer received SECOND dose of COVID-19 vaccine at 0910 in medical center and transferred to post vaccine observation. At 0935 provider notified that customer was feeling sweaty with tingling in her tongue. Customer appears mildly flushed, calm. States that she chose to wait a little longer in the observation room because she does not ?feel right.? Customer moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. She reports ?tingling? in the middle of her tongue and is feeling hot and diaphoretic ? different from the same menopausal symptoms that has been experiencing prior to this appointment. BP 120/78, HR 71, O2 95% RA, RR 18. Lungs CTA, RRR. Customer accepts Benadryl 50mg PO @ 0939. No rash, hives noted on exposed skin or at site of injection in left arm. Customer monitored at site. Over the course of the next 40 minutes, she reports feeling better. BP 120/70, HR 78, O2 97% RA, RR 16 @ 1022. She states that her tongue is still a bit tingly but denies feeling other worrisome symptoms she was previously experiencing. She denies feelings of facial/tongue/throat swelling, CP, SOB. Reports slight dizziness that she feels is related to Benadryl. Customer's husband (medical provider) present to drive her home. Customer states she will not be home alone. Customer aware that this provider will notify PCP Team of incident for post vaccine check in. Customer denies questions/concerns at this time. Customer released from site at 1025 ambulating independently with steady gait, no escalation of symptoms reported, no obvious s/sx of distress.
52 2021-01-27 numbness, feeling hot slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right sid... Read more
slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right side of jaw felt numb; Blood pressure went up to something over 90; fatigued; it hurt to open my mouth (gland by rt ear felt swollen); got a line of inflammation in my rt inside cheek; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EL0140), intramuscular at right arm on 23Dec2020 16:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication in two weeks included Multi vitamin, tocopherol (VITAMIN E), vitamin d3, bioidenticle estrogen/progesterone. The patient previously took Iodine, metronidazole (FLAGYL), Doxycycline, clarithromycin (KETEK); and known allergies to them. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt slightly light headed. Within 5 minutes right hand got red & hot, numb, heat in right arm & right side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. The patient took a benadryl. Next few days v fatigued & on p.m. of 24th it hurt to open her mouth (gland by right ear felt swollen). The patient got a line of inflammation in her right inside cheek & a tissue mound that had not gone away. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
52 2021-01-27 numbness By that evening my right arm went numb and I had a lot dizziness and brain frog. I was slow to stop ... Read more
By that evening my right arm went numb and I had a lot dizziness and brain frog. I was slow to stop at stop sign, and my daughter in law told me she wanted to drive me because I was scaring her and I was being mean to her, very snappy. The next morning I had a fever 100, muscle ache, heart racing, headache and I stayed in bed all day. I took 2000mg Ibuprofen, 800mg Tylenol, Benadryl 10mg. On the 20th I was still lethargic had body aches and heart was racing, I took 800mg Tylenol that day. The 21st I had dizziness, brain fog, heart racing, lethargic. The 22nd I contacted the work Nurse and let her know what was going on, my heart rate was 140. They told me I was probably having a reaction and would go away in a couple days. On the 24th,25th,26th,27th I started having chest pain, lethargy. I had a clinic visit with my PCP on the 28th and she said my BP was 160/90, I never had BP issues. She ran test. The 29th I still had brain frog, lethargy, chest pain. I could feel my heart beat in my ear especially at night, I have never has BP issues in my life. On the 30th my heart ponding sound was in my ear. January 16th I went to the ER my heart was 130 and BP 187/108, they did a full work up on me. She started me on Metprolol-50mg(extended release). I seen the cardiologist on 1/20 and told me I had left atrial enlargement , mitro-valve regurgitation . I had an echo- cardiogram on 1/25. The medicine has definitely helped me .
52 2021-01-27 pain in extremity Arm pain, nausia, vomiting, fatigue and slept for 18 hours straight.
52 2021-01-27 seizure Petite mal seizure blank stare with poor respond to staff. Has not experienced this effect under cur... Read more
Petite mal seizure blank stare with poor respond to staff. Has not experienced this effect under current med regimen in 3 years according to caregiver.
52 2021-01-28 burning sensation Started to feel an irritation behand my right ear, then along my jaw line. Thought it was irritatio... Read more
Started to feel an irritation behand my right ear, then along my jaw line. Thought it was irritation from mask wearing. Then I had a burning sensation in my hair. Similar to a sunburn then getting chills. Wednesday night I noticed three pimple like bumps in my hair--right posteriorly. A bit itchy at times. Thursday right under my jaw line seems to have swelling. This morning it feels the same. Burning like irritation in my hair.
52 2021-01-28 feeling cold Extream fatigue and chills unable to continue work. I am on day 3 now at home coming in and out of ... Read more
Extream fatigue and chills unable to continue work. I am on day 3 now at home coming in and out of sleep and freezing cold. Hoping it won't last much longer.
52 2021-01-28 numbness, tingling 1/25/2021 11:59:51 AM > 1145: BP 138/74, P 73, O2 98 Five minutes after receiving vaccine patient c... Read more
1/25/2021 11:59:51 AM > 1145: BP 138/74, P 73, O2 98 Five minutes after receiving vaccine patient c/o numbness and tingling in L arm where vaccine was administered with radiating pain to L shoulder, RN added 10 minutes to observation and educated patient to go to the nearest ER if symptoms aren't resolved 1/26/2021 09:08:07 AM > called to check on patient, message left
52 2021-01-28 pain in extremity Vaccine was on Wednesday 1/27/21 at 8:30. Felt a little off and sore arm during the day Wednesday.... Read more
Vaccine was on Wednesday 1/27/21 at 8:30. Felt a little off and sore arm during the day Wednesday. Started with some body ache during night ( approximately 13:30 a.m.) at sleep. Woke up at 5 a.m. with fatigue, significant nausea and a headache. Unable to go into work. Headache improved by mid day. The fatigue and nausea continued and gradually decreased, lasted until laterThursday evening. Returned to work at 6:30 a.m. on Friday.
52 2021-01-29 feeling cold Within 10 minutes, sensation of very cold skin through out my body, lasted 4 hours. Transient elevat... Read more
Within 10 minutes, sensation of very cold skin through out my body, lasted 4 hours. Transient elevated systolic BP, better within 30 mins. Also mild body itching, still having. Woke up this morning, ~24 hours post- injection with sever joint and muscle aches, chills etc. had to cancel work.
52 2021-01-30 feeling hot Pt received Pfizer COVID-19 vaccine. Approximately 8 minutes after administration, pt alerted me to ... Read more
Pt received Pfizer COVID-19 vaccine. Approximately 8 minutes after administration, pt alerted me to feeling hot with mild chest tightness. She stated she has anxiety and was anxious about receiving vaccine. She confirmed no swelling of the tongue, no SOB, no itching or other signs of anaphylaxis. Pt given diphenhydramine x2 and famotidine x1 along with a cup of water. Pt requested O2 and BP be monitored. O2 sat never below 97, BP was high initially at 153/112. Pt also had jacket on initially. Pt advised to breath and relax. Pt reassessed after 10 minutes. Removed jacket for BP check which had come down to 132/94 which pt states is baseline for her as she does have a bit of high BP. She also reported at that time feeling better and had calmed down. She stated she really felt it was anxiety. She left with instructions to call 911 or seek emergency attention if Sx reoccur.
52 2021-01-30 feeling jittery Upset stomach, jittery feeling, mild headache
52 2021-01-30 pain in extremity Chills Headache Soreness in arm
52 2021-01-31 weakness Approx 4pm 1-31-2021, I began to feel aching and weak. About 5 min later severe chills and fever en... Read more
Approx 4pm 1-31-2021, I began to feel aching and weak. About 5 min later severe chills and fever ensued. Fever was 101.8 F. Extreme fatigue. Went to bed at 6:30pm as headache came on also. Middle of the night woke up soaking we as fever broke. Feel just a bit aching and fatigued today 2/1/2021
52 2021-01-31 weakness fever between 103 to 103 F; Severe body aches; fatigue; generalized weakness; This is a spontaneous ... Read more
fever between 103 to 103 F; Severe body aches; fatigue; generalized weakness; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date not provided), via an unspecified route of administration in the left arm on 07Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included Meniere's disease, and allergies to Latex. The patient previously took cefalexin (KEFLEX) and codeine and experienced allergies. The patient also took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 17Dec2020 17:30 in the left arm for COVID-19 immunization. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications. On 08Jan2021 03:00, about 10 hours post vaccine, the patient experienced fever between 103 to 103 f, severe body aches, fatigue, and generalized weakness which lasted until about 60 hours post vaccination. The patient has not undergone COVID testing post vaccination. The outcome of the events was recovered on 10Jan2021 15:30.; Sender's Comments: Based on a compatible temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-01-31 weakness Bouts of vertigo; Dizziness; Weakness; Nausea; This is a spontaneous report from a contactable nurse... Read more
Bouts of vertigo; Dizziness; Weakness; Nausea; This is a spontaneous report from a contactable nurse (patient). A 52-years-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: e10142) via an unspecified route of administration on 13Jan2021 09:15 at single dose in left arm for COVID-19 immunisation. She received the first dose (Lot number: Ej1658) in left arm on 23Dec2020 06:30 PM for COVID-19 immunisation. Medical history included diabetes, hypertension. The patient was not allergic to medications, food, or other products. Concomitant medication included metformin, metoprolol tartrate (METPROLOL), triamterene, rosuvastatin, pyrvinium (TRU). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the 2nd dose on 13Jan2021, experienced weakness, dizziness and nausea at around noon next day (14Jan2021 12:00 PM) then at around 6:00 pm bouts of vertigo. Up to now 5 day after the onset dizziness and vertigo still present. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for events. Events outcome was not recovered.
52 2021-01-31 weakness Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chil... Read more
Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chills and fever of 100.7 with episodes of sweating profusely. 1/19/21 Pt states fever continues, body aches, (L) axillary lymph node swelling, HA, Nausea and a episode of Tachycardia that she recorded temp. ranged 101-102.2. 1/21/20 Pt stated to have cont. fever 102.2, HA, BA, sweating and lymph nodes swelling from (L) axillary to back painful. Pt States on 1/21/21 cont. sweating loss of appetite, nausea, weakness, fatigue injection site pain, no redness, warm, and palpable lump. Pt stated 1/23/21 body aches and fever. Pt resting drinking fluids as tolerated and taking advil 400 mg PRN 4mg Zofran
52 2021-01-31 discomfort, restless legs syndrome initially felt very nauseated, later that day had cold chills, felt like she had a fever, always run... Read more
initially felt very nauseated, later that day had cold chills, felt like she had a fever, always runs 96.6, temp was 99.5, went to bed, woke up thru the night with 'restless legs' could not get comfortable, joint/body pains, fatigue, as of today 2/1/21 still has joint pains and restless leg syndrome, needs sleep aids, taking several supplements for inflammation, omega 3, turmeric, vit C, apple cider vinegar, Tylenol and Advil (starting to upset stomach), going to MD this week
52 2021-01-31 feeling hot, pain in extremity Day after vaccine, severe arm pain to the extent left arm was minimally functional. Moderate arm pai... Read more
Day after vaccine, severe arm pain to the extent left arm was minimally functional. Moderate arm pain 2 additional days. Minor arm pain for few more days. Fatigue, general tiredness, sore throat for a week, although still experiencing sore throat. Unsure if that's environmental. Back pain (kidney area) beginning few days after injection, lasting several days. Non-muscular pain, more internal such as kidney pain. Worst symptoms: Itching, redness, swelling, inflammation below the injection site, approx 3"Hx7"W band across my left arm,beginning about 2" below the point of injection. Today is day 12 and I'm still experiencing this. Moderate itching 24 hrs, mild swelling, red, hot, inflamed. Symptoms are less severe at this point.
52 2021-01-31 numbness, feeling hot "Felt a funny sensation in my arm. It goes all the way down to my fingers. Its a dull numbness sen... Read more
"Felt a funny sensation in my arm. It goes all the way down to my fingers. Its a dull numbness sensation." She has full ROM & and feels warm. Hasn't had this before. More noticed on lateral position left arm. Only fingers affected: pinky and ring. 06:14PM SpO2 100%, HR 72, BP 120/83
52 2021-01-31 migraine Pfizer-BioNTech Covid-19 vaccine EUA HA and migraine
52 2021-01-31 migraine 39 hours after I received 2nd injection, started with bad migraine (3x as bad as usual migraine), di... Read more
39 hours after I received 2nd injection, started with bad migraine (3x as bad as usual migraine), diarrhea, nausea, had temp of 99.5F for one day, fatigue.
52 2021-01-31 tremor Chills & shaking-lasted 24 hours Severe congestion-lasted 2 days Throat swelling-this happened the s... Read more
Chills & shaking-lasted 24 hours Severe congestion-lasted 2 days Throat swelling-this happened the same time as the congestion started and made me feel like I could not breathe. It only lasted a few minutes. Fever of 102.9-fever lasted less than 24 hours Severe headache and body aches-lasted 72 hours Nausea and vomiting-could not even keep anti-emetics down. Lasted 48 hours. I know many of these effects are considered a normal reaction to the vaccine. However, the throat swelling and feeling like I could not breathe was concerning. It happened about 30 minutes after the chills/shaking started and right before I actually began to feel sick.
52 2021-02-01 weakness I felt weak; hard to focus; fatigued; This is a spontaneous report from a contactable healthcare pro... Read more
I felt weak; hard to focus; fatigued; This is a spontaneous report from a contactable healthcare professional (the patient). A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 19Jan2021 at 12:45 (at the age of 52-years-old) as a single dose for Covid-19 immunization. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient's concomitant medications included omeprazole (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 19Jan2021 at 13:30, the patient experienced felt weak, hard to focus, and fatigued. It was reported that the shot was at 12:45 pm, the patient had to lay down until she went to bed. Felt 80% better in the morning. The patient did not receive any treatment for the events. The clinical outcome of the events asthenia, disturbance in attention and fatigue was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
52 2021-02-01 pain in extremity painful arm; fatigue/body fatigue/she felt fatigued; sick; abdominal cramping; diarrhea; This is a s... Read more
painful arm; fatigue/body fatigue/she felt fatigued; sick; abdominal cramping; diarrhea; This is a spontaneous report from a contactable nurse, the patient. This 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3246), dose 1, single dose via an unspecified route of administration in the left upper deltoid on 18Jan2021 at 18:00 (at the age of 52 years-old) for COVID-19 vaccination. Relevant medical history included ongoing diabetes type 2 in 2011. Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Jan2021, the patient experienced a painful arm, more painful than other vaccines and then she had body fatigue about 2 hours after the injection. illness, diarrhea 3 times and abdominal cramping that was painful. Seriousness was not provided. It was unknown if any treatment was given. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of events, painful arm and fatigue/body fatigue was not recovered. The clinical outcome of events sick, abdominal cramping and diarrhea was unknown.
52 2021-02-02 weakness I exp fever greater than 100.9, fatigue, screaming headache,chills,weakness lasting about 4 day. Als... Read more
I exp fever greater than 100.9, fatigue, screaming headache,chills,weakness lasting about 4 day. Also around the injection site was extreme pain. I missed 2 days of work.
52 2021-02-02 burning sensation 4 days post vaccine developed front and back torso rash with burning and itching
52 2021-02-03 burning sensation Normal vaccine related symptoms 24-48 he following vaccine, seemed resolved by day 5. On day 6 start... Read more
Normal vaccine related symptoms 24-48 he following vaccine, seemed resolved by day 5. On day 6 starting feeling a burning sensation, a sore developed at the injection site. Today is 17 days post injection, the sore is scabbed and resolving, burning has subsided, but shoulder is tight and somewhat painful when doing something like yoga.
52 2021-02-03 numbness, tingling Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS ... Read more
Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS at the site. Waited another 20 mins and the symptoms did not get worse or rapidly improve. I had a prescheduled doctor appointment and went directly to the doctor's office after the vaccine. Dr. confirmed that I had swelling and redness in my face and prescribed Methylpredsisolone 4mg 21 pack of steriods to take. That medication removed the symptoms. On 02/01/21, 24 hrs after the last dose of the pack, the face swelling and tingling returned. As recommended I took Benedryl 2 tablets / 3 doses. I returned to Doctor's office on Tues 02/02 where she prescribed Presnisone 20mg for 5 days after seeing the swelling in my face and she said my lymph nodes were swollen as well.
52 2021-02-03 muscle spasms, feeling of body temperature change allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vac... Read more
allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. They evaluatedI started feeling better towards the end of last week. Additional information for Item 18: allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. me for another 15 minutes and they recommended that I be evaluated in the ED. The right arm was noticed to be red. The injection site was painful. I was evaluated by the MD and given medications per their protocol (epi, Benadryl, famotidine, steroid). I was discharged home around 1830 (with a ride) after my throat seemed to be getting better. I was discharged with an Rx for steroids, blockers and and epi pen. Later that night at about 2200, I woke up with my face/scalp itching. I continued feeling achy, intense headache, hot/cold, foggy mind. I called in sick for my shift on 1/19. I returned to work on 1/20 with minor symptoms.I was evaluated by my MD on 1/21 and had minor expiratory wheezes (I have asthma). I seemed to be feeling better until Saturday and then stomach cramping/muscle cramping (noticeable on the right hand/injection side), bad headaches, fatigue have resumed. ; 2/2 I started feeling better towards the end of last week. Still feeling off but able to do my normal routines.
52 2021-02-03 muscle spasms felt a tinge of pain in my sacral area/It got worse each hour/ It worsen daily/It became painful; Be... Read more
felt a tinge of pain in my sacral area/It got worse each hour/ It worsen daily/It became painful; Became limited in movements such trying to picking up items from the floor; difficulty running or walking fast as I usually do; Lots of spasms in the sacral area; Difficulty sleeping; Difficulty sleeping and going from sitting to standing; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), via an unspecified route of administration in the left arm, on 09Jan2021 15:30, at single dose, for COVID-19 immunization, at the pharmacy. There was no medical history and no known allergies. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN), diphenhydramine hydrochloride (BENADRYL), herbal nos, minerals nos, nutrients nos, vitamins nos (CATALYST) and "Muscle Strength". The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not have other vaccines in four weeks. The patient reported that on 12Jan2021 at 14:00, "I ardently felt a tinge of pain in my sacral area. Then it got worse each hour. Then I became limited in movements such trying to picking up items from the floor and difficulty running or walking fast as I usually do. It worsened daily. I would workout and then I experienced lots of spasms in the sacral area. It became painful. The patient experienced difficulty sleeping and going from sitting to standing." The events resulted to "Doctor or other healthcare professional office/clinic visit". Treatment for the events included prescription muscle relaxants (unspecified), ibuprofen and "topi". The patient was recovering from the events.
52 2021-02-03 pain in extremity Day of shot, slightly sore arm. Next day, very sore arm so much so that I was unable to sleep on tha... Read more
Day of shot, slightly sore arm. Next day, very sore arm so much so that I was unable to sleep on that side, plus mild headache, feverish, chills, and body aches. The headache, feverish, chills and body ache lasted all day until I took 400 mg of ibuprofen.
52 2021-02-03 pain in extremity I received vaccine on 2/3/21 at 10:35 am. That evening I was tired and had arm tenderness. The next... Read more
I received vaccine on 2/3/21 at 10:35 am. That evening I was tired and had arm tenderness. The next morning (4:30 am), when I woke up for work, I was unable to walk without assistance due to dizziness. If I do not move my head, I am able to sit or walk slowly.
52 2021-02-03 tremor Systemic: Headache-Severe, Systemic: Other- Heart palpitations, dry/burning lips, hand tremors-Mediu... Read more
Systemic: Headache-Severe, Systemic: Other- Heart palpitations, dry/burning lips, hand tremors-Medium; lasted 1 day
52 2021-02-04 pain in extremity Developed immediate left arm pain that worsened to rotator cuff injury and decreased range of motion... Read more
Developed immediate left arm pain that worsened to rotator cuff injury and decreased range of motion at left shoulder. Patient went to see orthopedic physician on Jan 29, 2021 and started physical therapy Feb 2, 2021. Currently physicl therapy is ongoing.
52 2021-02-06 weakness Around 11am: Chill, fever 1-2 hours later: started to cough, had fatigue, body aches, temp went up ... Read more
Around 11am: Chill, fever 1-2 hours later: started to cough, had fatigue, body aches, temp went up to 102.1 F (ear) Around 4pm: took theraflu and fell asleep Around 10pm: ate some soup, took theraflu and fell asleep (temparature: 100.2 F) Next day (2/5/2021): felt better except weakness, rested whole day Next day (2/6/2021): went back to almost normal condition
52 2021-02-06 pain in extremity, tremor 1.1/14/2021- first dose Pfizer COV19 vaccine injection - day#1- left arm (injection arm) feel so... Read more
1.1/14/2021- first dose Pfizer COV19 vaccine injection - day#1- left arm (injection arm) feel soreness and ache - day#2- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish - day#3- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish, plus irregular heart beat - day#4- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish intensified - day #5- body ache subsided, Headache and nausea continued to feel intensified. Fever now turn into chills - day#6- unbearable headache and worse nausea feeling, chills, need to leave work in the afternoon. Throwed up and shaking. Took many headache medications and antinausea medications but nothing work. 2. 2/5/2021 @1630- received 2nd dose Pfizer COVID 19 vaccine - day#1, 1 hour into receiving vaccine, feeling dizzy and "hangover" type reaction. 2 hours into receiving vaccine, developed irregular heart beats. Left arm injection pain and sore arm. - day# 2: entire body ache, joint pain, headache and nausea - day#3: severe headache and feeling nauseous. Took many headache and antinausea medications. - will continue to follow adverse reactions.
52 2021-02-07 slurring, concussion As described to this writer- patient was home at 11PM, got out of bed as she couldn't sleep and wen... Read more
As described to this writer- patient was home at 11PM, got out of bed as she couldn't sleep and went into the kitchen to make coffee. She states she woke up 15 minutes later and had lost consciousness. She went to her husband who said her words were slurred. She did not seek medical help until the following day when urged by her co-workers to do so. Then she brought a note back to work that stated she had a concussion and nothing of how or why she got the concussion. On February 4th i received a copy of her office visit that state she is alright to return to work and get the 2nd dose of vaccine with stipulations of having the following day off from work.
52 2021-02-07 migraine Migraine
52 2021-02-07 tremor This was my second dose. Fever as high as 103.4F. Fever lasted 24 hours above 100.0F Chills, Sha... Read more
This was my second dose. Fever as high as 103.4F. Fever lasted 24 hours above 100.0F Chills, Shaking for 4 hours from about 8/9 pm to 12/1am. Nausea, vomiting, bowel pain, inflamed rectum after bowel movement the next day, loss of hearing, dizziness, Trying to sleep and waking up gasping for air about 5 times though out the early morning. Sever Headache which lasted Two and a half days. About 2 pm on 2/5/21 I took some Emetrol for the Nausea, and Tylenol for headache and fever. I took Tylenol again the evening of 2/5/21. On 2/6/21 I Tylenol and then Ibuprofen then Excedrin. On 2/7/21 I took Excedrin once and my headache was finally gone.
52 2021-02-08 feeling hot Patient received 1st dose 3 weeks prior without reaction. She received second dose today at approxim... Read more
Patient received 1st dose 3 weeks prior without reaction. She received second dose today at approximately 11:30am. She felt fine after the second vaccination, until about 1:30-1:45pm. Patient c/o a "heat rush", headache, and hives on BUE. Patient vitals were WNL except HR was slightly tachycardia at 107bpm. Respirations were baseline at 18. Patient denies sob/anaphylaxis. Benadryl administered orally, and monitored. No reaction was had with the first vaccine.
52 2021-02-08 pain in extremity Sore arm Tired feeling Body malaise
52 2021-02-09 bell's palsy, numbness On February 4, 2021, patient woke up at 3 a:m, left eye kept opening and closing, vision was blurry,... Read more
On February 4, 2021, patient woke up at 3 a:m, left eye kept opening and closing, vision was blurry, and left side of face numb by lips and jaw. She took 2 Benadryl and took a nap Thursday afternoon. She went to the ED later and was told it may be Bells' Palsy but was referred to PCP. She is on 5 mg Prednisone but rheumatologist increased dose and put on 5 day regimen. She saw PCP and he told her she had Bell's Palsy and just to follow regiment prescribed by rheumatologist.
52 2021-02-09 difficulty speaking, weakness Pain, weakness, fatigue, abnormal mentation, tongue throbbing, cough, hoarse voice
52 2021-02-09 flushing, feeling hot Felt hot and flushed. BP 130/82, P74, no respiratory sx. no wheeze. no orbital swelling.received 25 ... Read more
Felt hot and flushed. BP 130/82, P74, no respiratory sx. no wheeze. no orbital swelling.received 25 mg benadryl po. felt better in 15 minutes
52 2021-02-09 pain in extremity Sore arm, full body aches and extreme fatigue for 24 hours starting 2/6.
52 2021-02-09 pain in extremity Moderate pain in arm of the injection, some all over body aches, fatigue approximately 1 day after t... Read more
Moderate pain in arm of the injection, some all over body aches, fatigue approximately 1 day after the second injection. After the first injection only pain in the arm which received the injection. Took 2 Tylenol with onset of the pain and repeated when necessary with the first injection. For second injection took 2 Tylenol pills and arm pain and body aches subsided. After both injections, side effects only lasted a day.
52 2021-02-09 tingling History of similar reactions with each flu vac. and therefore she stopped taking flu vacs. 5 years a... Read more
History of similar reactions with each flu vac. and therefore she stopped taking flu vacs. 5 years ago. Developed nausea, lightheadedness, headache, and shortness of breath 14 min after vaccine. Vital signs stable on admission to observation area and heartrate regular with apical auscultation. Forty-five min after vaccine, began having some chest pressure and tingling in her arms. Her heart rate irregular at 68 bpm. Employee called her cardiologist who advised her go to the emergency room. No history of angioedema.
52 2021-02-11 numbness, feeling hot In less than 15 minutes after the Covid shot, I felt intense heat in my face and all over my body. ... Read more
In less than 15 minutes after the Covid shot, I felt intense heat in my face and all over my body. My right hand felt numb. I felt a rushing feeling in my veins like I'd been given an IV in my hand. I had red blotches on my neck. I was given 25 mg of Benadryl by the onsite doctor. Within an hour the neck blotches were gone. The numbness in my right hand went away after five hours. The intense heat in my face and entire body was gone after two hours. The following day, I felt lightheaded.
52 2021-02-11 migraine 02/11/21@1435-Pt complaing of naueas and headache then stated she was short of breath after vaccine ... Read more
02/11/21@1435-Pt complaing of naueas and headache then stated she was short of breath after vaccine given. RN contacted, pt given Benadryl 12.5 mg. Pt stated she has anxiety. Pt became upset and started crying. Pt closed observed. O2 sat 94% P-73; BP 152/92. Pt states she also get migraines and feels like one is starting. Tylenol 320 mg oral liquid given. Pt started vomiting at 1450, stated she vomited Tylenol. 1453-BP 144/100; p-70; O2 95%. Pt states she has not eaten since yesterday afternoon and hasn't really been taking much fluids. Offered pt a cookie to eat and water to drink. Pt stated she felt better. Continued to observe pt. NP came out to assess pt. Pt states she would like to go to ER to be seen. Pt was instructed to go to the ER, pt refused. AMA form completed and signed. 1530- Pt's BP 164/110 right arm, 162/102 left arm. Pt started vomiting again and stated she does not feel good. Transport called and arrived. Pt's BP done by fire and rescue was 176/104. Pt taken via ambulance. gp,rn
52 2021-02-11 night sweats Starting last night some nausea, then a lot of sweating in the night as well as ongoing mild nausea.... Read more
Starting last night some nausea, then a lot of sweating in the night as well as ongoing mild nausea. Low fever. Now I have general fatigue and muscle aches.
52 2021-02-11 tremor 12:30 EE state feeling "weird" dizzy and shaky. EE was seated with legs elevated. Provided juice an... Read more
12:30 EE state feeling "weird" dizzy and shaky. EE was seated with legs elevated. Provided juice and cool compress HR 68 RR 16 12:43 feeling "back to normal" Increased sneezing and nasal congestions NKA continue to monitor 13:00 Hr 80 RR 18 SPO2 100% BP 184/89 EE reportedly hypertensive at baseline 13:05 Benadryl 25mg po provided 13:10 Continues to feel "back to normal" Ambulating well. Escorted to parking structur by RN.
52 2021-02-12 flushing, numbness Numb face, lips, mouth, tongue, flushing, dizziness,
52 2021-02-12 numbness On 2/4 it began with severe pain from behind my left ear radiantly upward to the top of my head.I ha... Read more
On 2/4 it began with severe pain from behind my left ear radiantly upward to the top of my head.I have numbness on the left side of my face with mouth distortion (only opens to right side)My left eye does not blink or close.I tape it close nightly per MD.
52 2021-02-12 tingling Patient received the Pfizer COVID immunization today, About 3 hours ago. About 15 minutes after th... Read more
Patient received the Pfizer COVID immunization today, About 3 hours ago. About 15 minutes after the administration of the vaccine patient stated she developed mottling of the skin, paresthesias as well as palpitations and throat tightness. Was given 25 mg oral Benadryl after initially experiencing the symptoms. Subsequently 1 hour later was given another 25 mg of oral Benadryl because symptoms remain. Was subsequently transferred here to Urgent Care about 30 minutes ago. Patient stated that her symptoms remained of throat tightness however the palpitations and paresthesias as well as skin mottling resolved. Denies any rash at any point. Denies any swelling of the face, mouth, lips or body. Denies any shortness of breath or chest pain.
52 2021-02-12 tingling Lightheaded, tingling in legs and feet, palpitations
52 2021-02-13 hot flush, feeling cold Ended up with full symptoms, nausea, vomiting, lightheaded, fatigue, loss of appetite, sore at injrc... Read more
Ended up with full symptoms, nausea, vomiting, lightheaded, fatigue, loss of appetite, sore at injrctionsight, ended up at ER with hypomagnesmia, hot/cold flashes. Body aches and cough with sore throat.
52 2021-02-14 burning sensation, tingling, feeling cold 1 hour post injection, patient returned to the vaccine clinic c/o burning and tingling (L) side of f... Read more
1 hour post injection, patient returned to the vaccine clinic c/o burning and tingling (L) side of face near cheek bone & eye. While talking, she developed a "cold sensation, like when you get IV fluids" on her left side.
52 2021-02-14 tremor, discomfort, pain in extremity, feeling cold At approximately 16:00 started shaking; extremely cold; Both arms as well as pectoral muscles hurt; ... Read more
At approximately 16:00 started shaking; extremely cold; Both arms as well as pectoral muscles hurt; Both arms as well as pectoral muscles hurt; Very dizzy; fever up to 102.1 Fahrenheit; uncomfortable like I needed to get something out my body; This is a spontaneous report from a contactable nurse reported for herself. A 52-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 29Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included HTN (hypertension). Concomitant medication included losartan and hydrochlorothiazide (HCT) received in two weeks. There was no other vaccine received in four weeks. At approximately 29Jan2021 16:00, the patient started shaking and extremely cold. The patient experienced both arms as well as pectoral muscles hurt. The patient experienced very dizzy and uncomfortable like she needed to get something out her body. This lasted for over 24 hours with fever up to 102.1 Fahrenheit. All events occurred on 29Jan2021 16:00. The events resulted in congenital anomaly or birth defect (pending clarification). No treatment received for the events. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-02-15 burning sensation, numbness approx 4-5 hours after vaccine I began to have burning on the soles of my feet when I walked. It fel... Read more
approx 4-5 hours after vaccine I began to have burning on the soles of my feet when I walked. It felt like I was walking on hot coals. This continued in both feet for approx 24 hours. It never went away completely in the R foot. My right foot continues to have burning pain, inflammation, and occasional numbness in my toes. It is more localized to plantar fasciitis area now. I have had a cortisone shot, muscle rub salve, anti-inflammatories with no relief in R foot. I have another podiatry appt tomorrow and an appt with neurologist on Thurs. PCP and podiatrist said they think it may be an inflammatory response to the vaccine that irritated something that was "already brewing" in that area.
52 2021-02-15 muscle spasms, tremor (during the night of sleep only) Fever, violent shaking, head ache, charlie horse in calves; (daytim... Read more
(during the night of sleep only) Fever, violent shaking, head ache, charlie horse in calves; (daytime) achy, sore joints, head ache, fever
52 2021-02-16 numbness, tingling Patient experiences numbness and tingling on left side of face 3-4 hours after vaccination. She ment... Read more
Patient experiences numbness and tingling on left side of face 3-4 hours after vaccination. She mentioned it felt like going to the dentist and having numbing medicine. She states it lasted for 3 days without medical intervention. Shed stated that on Monday the 8th she went in for estrogen and testosterone "pellets", Symptoms of numbness and tingling returned on Saturday the 13th with numbness, tingling on left side of her face and roof of her mouth. On Sunday the 14th she started getting a rash on the left side of her face and jaw line. She called today to report these symptoms and will be speaking with her PMD tomorrow.
52 2021-02-16 migraine with aura Migraine aura. It started the morning after the 2nd COVID vaccine dose. Continued for 10h. Responde... Read more
Migraine aura. It started the morning after the 2nd COVID vaccine dose. Continued for 10h. Responded to ibuprofen, but it comes back. Ongoing.
52 2021-02-16 seizure like phenomena not feeling well , seizure like activity. I ER itch feeling. treated with Benadryl.
52 2021-02-17 discomfort I had an abscess tooth that became infected; UTI; headache; stomach bloating; pressure and discomfor... Read more
I had an abscess tooth that became infected; UTI; headache; stomach bloating; pressure and discomfort; blood in my urine; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 18Jan2021 at 10:30 AM as a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient ha d no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination, has not been tested for COVID-19 since the vaccination, and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine and also did not receive any other medication within two weeks of vaccination. The patient had a headache on 22Jan2021 for 5 days. She also had stomach bloating and pressure and discomfort on 22Jan2021. It was reported that when she saw blood in her urine, she went to a walk-in and was diagnosed with a UTI on 22Jan2021. She did 7 days of an antibiotic. Then on 30Jan2021, she had an abscess tooth that became infected. It was reported that the patient received antibiotics for both infections. It was reported that the events result in a doctor or other healthcare professional office/clinic visit and an Emergency room/department or urgent care. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
52 2021-02-17 facial pain chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and i... Read more
chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color, not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none. She then had copious amounts of thin nasal drainage to her left sinus/nostril. Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine. Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning. She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
52 2021-02-17 feeling hot, weakness On 02/16 Low grade fever 99.2 feeling hot like Nausea and diarrhea Feeling Tired/weak On... Read more
On 02/16 Low grade fever 99.2 feeling hot like Nausea and diarrhea Feeling Tired/weak On 02/17 Still feeling a bit tired some Nausea
52 2021-02-17 numbness, tingling numbness and tingling sensation on both legs, redness on face and neck with mild rash on face and ne... Read more
numbness and tingling sensation on both legs, redness on face and neck with mild rash on face and neck
52 2021-02-17 pain in extremity profound sore arm difficulty in lifting by 8pm after shot, Fever and chills by 12 midnight with temp... Read more
profound sore arm difficulty in lifting by 8pm after shot, Fever and chills by 12 midnight with temp running 101.9, muscle joints ache had these symptoms until 6:30pm on Saturday 13th
52 2021-02-17 pain in extremity left arm pain and soreness
52 2021-02-18 feeling hot Immediately felt heart tightness/warmth; completely resolved the following morning Delayed- itching ... Read more
Immediately felt heart tightness/warmth; completely resolved the following morning Delayed- itching (full body); Began after 15-20min lasted the remainder of the day and nearly completely resolved the following morning. Delayed Hives (to neck/face above neck); resolved the following morning Delayed injection site soreness; Began 4-5hrs after the injection worsened, extremely tender to touch Following morning the injection site is slightly raised, red to pink, warm to touch, swollen 2-2.5cm in circumference around the injection site, some itching remains. General fatigue 4-5hrs following the injection. Resolved the following morning
52 2021-02-18 tingling I awoke at 3 pm with a mild pain/ tingling of nerve from left elbow to fingers that is constant that... Read more
I awoke at 3 pm with a mild pain/ tingling of nerve from left elbow to fingers that is constant that increases in intensity if my arm hands down at side (feels like the sensation after striking your elbow). Can?t stop thinking about this sensation/pain no matter what I am doing.
52 2021-02-18 tremor Severe headache, body aches, chills, and fever. Fever reached 107.1 but was reduced with Tylenol and... Read more
Severe headache, body aches, chills, and fever. Fever reached 107.1 but was reduced with Tylenol and cold compresses. Chills and shaking started approximately 10 or 11 hours after vaccine. Temperature is now fluctuating between normal to 100. Severe headache and body aches persist.
52 2021-02-18 tremor On 2/16/21, the morning after the vaccine I had a bad headache and spontaneous nose bleed. That even... Read more
On 2/16/21, the morning after the vaccine I had a bad headache and spontaneous nose bleed. That evening I had upset stomach, exhaustion and loose stool. The next day, 2/17/21 I had headache all day and continued exhaustion. In the evening, I took my blood pressure and it was 156/98. An hour later, it was 165/98. By 9:30 p.m it had risen to 172/98 and I was shaking and having difficulty walking/talking. I went to the emergency room. My blood pressure was still 172/98 upon arrival so blood work, EKG, chest X-ray, and CT scan were performed. I was released later that evening when my blood pressure came down to 156/98 . My normal blood pressure is always 120/80 or lower.
52 2021-02-21 pain in extremity 02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Ap... Read more
02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Approx. 5:30pm: cramp type pain in spleen area that subsided in approx. 15 minutes. 02/20 Approx. 6:00pm: arm pain & swelling at injection site that slowly increased over time. 02/21: Arm pain increased - very painful, swelling, limited ability to move arm without pain. 02/22: At the time of this submission, the arm pain & swelling is not as bad - it's minor now.
52 2021-02-21 cold extremities Within 15 minutes, left arm got got really cold - like ice. Lasted about 2 hours. The arm to the to... Read more
Within 15 minutes, left arm got got really cold - like ice. Lasted about 2 hours. The arm to the touch was warm but it felt like it was in ice bucket. They kept me for 2 hours. Started to resolve in those two hours but didn't go away completely. By evening it was mostly returned to normal. Next day, I woke up with flu-like symptoms - felt like I had the flu. Every hair on my head hurt; wanted to sleep; no appetite. Three in afternoon - I felt much better. As quickly as it came on, it went away quickly.
52 2021-02-22 burning sensation Burning itchness all over body
52 2021-02-23 numbness Cuyamaca team 2 was notified of a potential adverse reactions of a patient whom just received the se... Read more
Cuyamaca team 2 was notified of a potential adverse reactions of a patient whom just received the second dose of vaccine. The patient was found in her car with husband onscene appearing to be in minor distress. Per the patient she has a history of anxiety and feels that she is having a anxious epsiode. Patient admits to having a similar effect post first dose. Patient admitted to " fluttering in the chest" as well as numbness in the fingers, patient was slightly tachypnic upon inital contact. Patient was advised of calming measures and symptoms began to subside. A full 911 response was started and performed a AMA, Heartland CAD # 2021-00012209. "PFIZER COVID 19 VACCINE EUA"
52 2021-02-23 pain in extremity I exp fatigue, arm soreness, body ache and flare of Psoriasis lasting 48 hours,
52 2021-02-24 feeling hot, cold sweat Felt lightheaded, dizzy, hot clammy, feeling pressure in chest. HR down to 28. BP 90/40. Laid on bac... Read more
Felt lightheaded, dizzy, hot clammy, feeling pressure in chest. HR down to 28. BP 90/40. Laid on back with feet elevated. 911 called. EMS evaluated and pt was better and signed for no transport.
52 2021-02-24 numbness, feeling hot, tingling Hard to breath, itching .. hot feeling from left arm area spread to neck face head. Itchying all ... Read more
Hard to breath, itching .. hot feeling from left arm area spread to neck face head. Itchying all over, pins and needles feeling in my hands, numbness in lips ear cheek , headache neck pain. Tiredness.
52 2021-02-24 pain in extremity, burning sensation Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up ... Read more
Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up her arm; real red spot on wrist; her arms started stinging and itching; Hand and feet were itching off; burning; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283) intramuscular on the left arm on 13Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included acid reflux, antidepressant, normally wears contacts and puts reading glasses on over it. Family medical history of cancer. Concomitant medication included omeprazole (PROTONIX [OMEPRAZOLE]) for acid reflux and bupropion hydrochloride (WELLBUTRIN) as antidepressant. The patient went and got her first shot 2 weeks ago. She is a dental assistant. She woke up between 2am-3am on 13Jan2021 and her hands and feet were itching off. They were burning and itching and she did not have any rash. So Thursday, she had to work until 1. Her hands itched and she went home, took Benadryl and put Cortisone cream on hands and feet. She does not have a dose, lot or expiration for either. It would take 2 doses of Benadryl. They just continued to itch until Saturday and she went to a doc in the box and the doctor felt it was a reaction from the vaccine. You could not see anything except red where she scratched it. She gave her some medicine and she just went to pharmacy and the pharmacist said that is just like Benadryl. She started taking it and it immediately helped, but she only gave it to her for 5 days and when she finished, the itching started again. On 27Jan2021, her hands were itching off and she has red streaks going up arms and splotches. She does not have the name. It was like hydro something. She threw bottle away. She does not have a dose, lot or expiration. It improved and stopped when she was taking the medicine and on 26Jan2021, she had a real red spot on wrist, her hands have itched and itched. When her arms started stinging and itching, she pulled her sleeve up and it looks like streaks on her arms and elbows. She has these splotchy red whelps and streaks up her arm. She also noticed she had itching on her torso the day before. She needed to get glasses to see vaccine card. This was required before she took the vaccine, but she did feel like her eyes are worse all of a sudden. She normally wears contacts and puts reading glasses on over it. It has only been in the last few weeks that she has noticed this. Now, her arms were starting to itch again after a dose of Benadryl. She was worried about 2nd shot. She does not want it to get worse and continue. She would like to speak with someone to find out if it would be recommended for her to get second dose or not. No ER or physician's office required: Doctor visit on 16Jan2021 and they prescribed a medication to help with itching and burning for 5 days and it worked and when she stopped taking it, it started back. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was at a Clinic for the hospital. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events itching and eyes have gotten worse was not recovered, events burning and pain in arm was unknown and recovering for the other events.
52 2021-02-25 numbness Numbness in jaw, lips, neck on left side. Tachycardia
52 2021-02-25 tremor Progress Notes (Nurse Practitioner) Pt called for follow up s/p covid-19 vaccine done on 02/24/2... Read more
Progress Notes (Nurse Practitioner) Pt called for follow up s/p covid-19 vaccine done on 02/24/21. She reports doing well and better today. She still has a sore arm where the injection site is. No redness or swelling nor fever. She also states that her cotton mouth sensation is gone. She is overall well. Pt is appreciative for the phone call. Denies any other concerns. Progress Notes (Nurse Practitioner) Attempt to reach patient for follow up. No answer. Progress Notes (Nurse Practitioner) Cosign Needed Expand AllCollapse All Date: 2/24/2021 Subjective Pt is a 52 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience chills/shaking "as if my internals are trying to come out.". She also reports of R arm pain "as if someone socked me in the arm" at injection site. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency room area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. PMH: depression/PTSD, recovered alcoholic and pill user x 8 years come this April. Currently on Zoloft, Abilify, Wellbutrin. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, muscle aches (R arm pain where injection site was) and headaches (she developed a headache later while she was in the bay about 15 minutes into her visit. Rates pain at 8/10) Patient denies fever, malaise/fatigue, facial swelling, ear pain, itching in ears, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin and abdominal pain She reported about 15 minutes into her visit with me of "Sudden onset of dry mouth.": Previous Reactions: when she was younger, she had an adverse reaction, unable to recall what, to the chicken pox vaccine. She's only been able to get one shot. She's tolerated other vaccines w/o issues. Objective Vitals Vitals: 02/24/21 0907 02/24/21 0926 02/24/21 0943 02/24/21 1000 BP: 135/84 128/71 120/73 101/71 BP Location: Left arm Left arm Patient Position: Sitting Sitting Pulse: 93 82 68 SpO2: 97% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is obese. She is not diaphoretic. Comments: intially appeared fatigued, not as alert. After drinking water, eating a granola bar. She started to come around HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Comments: R arm inspected. Warm, no erythema, swelling nor rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Affect is flat. Comments: initially flat/anxious. Pt was able to have normal mood by end of visit. Assessment/Plan Treatment included: water, snacks and ibuprofen for headache Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Doing well after observation. She has a ride. She was able to ambulate out to the front with co-worker. She is aware of precautions to watch for. Advised to place warm compress or ice to R arm. F/up with pcp as needed. Electronically Signed 2/24/2021 12:50 PM
52 2021-02-27 weakness Dizziness, Short of Breath and Weakness (Tired)
52 2021-02-27 numbness, weakness SOB, chest pain, numbness, tingling in mouth, nausea, weak. Cleared by EMS
52 2021-02-27 tingling The night after the shot I became ill with mild flulike symptoms: headache, fever of 101, aches, chi... Read more
The night after the shot I became ill with mild flulike symptoms: headache, fever of 101, aches, chills. This seemed fully within what I had expected and been told might happen, but as these symptoms eased up over the next 48 hours, I experienced, and continue to experience, a weird neurological paresthesia-type symptom where it feels as though my skin is covered in some kind of cold minty lotion. (Not the same as chills, though it sounds like it, I realize.) Mostly on my upper back, but also at the injection site, and sometimes other places too. Not painful, just distracting and kind of worrying. Not anything I have ever experienced before, and not related to any sort of external variable. I consulted with both a doctor and my brother and his wife (both doctors) by telephone. Everyone has advised a wait and see approach, but my brother (an epidemiologist) recommended that I report this as an adverse event.
52 2021-02-28 weakness, pain in extremity Severe diarrhea, chills, lack of balance, weakness, arm pain. Pain in the back of my head.
52 2021-02-28 tingling, numbness Left arm tingling slightly numb and left tip of my pinky is totally numb! It dissipated a bit mid d... Read more
Left arm tingling slightly numb and left tip of my pinky is totally numb! It dissipated a bit mid day and now it is numb again so I thought I would fill this out because it?s abnormal
52 2021-02-28 tingling Numbness of lips and tongue, paresthesias in upper extremity, nausea; LIP, and AMR gave Zofran and b... Read more
Numbness of lips and tongue, paresthesias in upper extremity, nausea; LIP, and AMR gave Zofran and breathing technique - reaction resolved. Extended monitoring was provided.
52 2021-02-28 tingling Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arm... Read more
Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arms/chest, and feeling like moving through water.
52 2021-03-01 flushing, feeling hot, cold sweat, slurring, tingling Complained of warm feeling after receiving first dose of Pfizer COVID-19 vaccine (lot EN6205, exp 6/... Read more
Complained of warm feeling after receiving first dose of Pfizer COVID-19 vaccine (lot EN6205, exp 6/30/2021). At 1029, EMT was checking in on client since she was in post vaccine waiting area for 30 min observation. EMT noticed flushed face and neck. Per client felt warm sensation and at 1031 stated metallic taste in mouth, feeling clammy with sweaty hands. PHN joined EMTs. First set of vitals: blood pressure 120/80, temperature 101.7 F. Alert and oriented, no shortness of breath, rash, itching, swelling, blurry vision, or tingling noted per client. Per client sulfa, shellfish, and contrast IV dye allergies. Medication client took this morning: Synthroid 75mcg. Clt reported she ate breakfast at 9am consisting of cereal and coffee, client reported a history of Bell's palsy 20 years ago with full recovery. 1034 temp 100.0 F. Assessed for arm drift, no tongue deviation, clt stated no tingling, able to move all extremities. 1042 vitals: blood pressure 120/100, pulse 77, o2 98, temp 99.0 F. Alert and oriented, clammy hands, no shortness of breath, no swelling. PHN offered client Benadryl, client declined. Informed client she would be kept longer for observation and client agreed. At 1047 temp 98.9 F, respiratory rate 24. At 1051 client stated tingling sensation on inner lips, metallic taste, dizziness, and mild burning sensation around eyes and nose area. PHN assessed for swelling in mouth, lips, face. PHN offered Benadryl again and client accepted. Client called husband who was in parking lot, client not driving. At 1054 Benadryl 50mg/ml IM on left deltoid. Vitals 1056: blood pressure 118/90, pulse 70, o2 98. Client informed vitals would be reassessed every 5 minutes. 1101 vitals: 99.1 F temp, blood pressure 118/78, pulse 77, o2 98. Per client dizziness and metallic taste were improving. 1106 vitals: pulse 75, o2 98, respirations 14, EMT unable to obtain blood pressure. Client complained of tingling on left index finder, PHN assessed bilateral grip strength, equal on both sides. 1114 vitals: blood pressure 128/72, pulse 74, o2 99. Per client, improvement of tingling sensation on lips, no metallic taste, no dizziness, no headache. Per client felt Benadryl effects. Vitals 1118: blood pressure 124/82, pulse 76, o2 96. Vitals 1124: blood pressure 128/78, pulse 75, o2 98. Client able to stand, denied dizziness. At 1133 noticed change in speech, slurred. Per client voice was different. called 911 at 1134. Paramedics arrived at 1142 and assumed care. Client transported to Hospital per client's husband request at 1149.
52 2021-03-01 flushing Patient received covid vaccine and experienced flushing immediately post vaccination and about 20 mi... Read more
Patient received covid vaccine and experienced flushing immediately post vaccination and about 20 minutes after vaccination had onset of headache. Felt like a band was wrapping around right side of head, pressure over right eye, and numbness/tingling of right eye noted. No loss of vision noted, no facial drooping noted. Complained of numbness and dryness of right eye continuing at least 30 minutes after vaccination. Noted it started to burn or itch 30 minutes after vaccination.
52 2021-03-01 sensory loss, tingling Within minutes of getting the vaccine I was on the floor. I was taken to the hospital and am still ... Read more
Within minutes of getting the vaccine I was on the floor. I was taken to the hospital and am still here. I can't feel anything below my knees and have weekness in my hands. I can't walk and have difficulty moving my legs. Doctors are saying that they don't know if I will ever walk again.
52 2021-03-02 breast pain Left axilla and breast pain since injection received.
52 2021-03-02 face paralysis, speech disorder, bell's palsy Left sided facial weakness, tongue feels numb on left side, speech just a little off but no left ar... Read more
Left sided facial weakness, tongue feels numb on left side, speech just a little off but no left arm weakness or anything else. Ear pain on the left side and headache. CT Head done on 2/26/21 at ER resulting in no acute intracranial process. Diagnosed with Bell's Palsy and started on 7 days of Valacyclovir HCL 1 gram - 3 times a day and Prednisone 20mg - 3 in the morning for 5 days. Completed course of Prednisone morning of 03/03/2021. Symptoms no better with medications.
52 2021-03-02 flushing itching to bilateral axilla and neck, itching to injection site (left deltoid), light headed, itchin... Read more
itching to bilateral axilla and neck, itching to injection site (left deltoid), light headed, itching to head, back, and bilateral legs. Reports flushed to face. Bumps to forehead.
52 2021-03-02 numbness 15 minutes after receiving her first dose of COVID-19 vaccine in her L arm, patient developed numbne... Read more
15 minutes after receiving her first dose of COVID-19 vaccine in her L arm, patient developed numbness in the L side of her face down to her shoulder. Her CN2-12 were grossly intact, her muscle strength was 5/5 in her UE. Patient denied any SOB, difficulty swallowing (able to swallow water), or swelling of neck. Her airway was patent and she had a normal oropharynx. Patient had another 10 minutes of additional observation. Her symptoms slightly improved prior to leaving.
52 2021-03-02 muscle spasms I slept all day; I could not eat; I could not get out of bed, I hurt so bad/Body aches; Muscle spasm... Read more
I slept all day; I could not eat; I could not get out of bed, I hurt so bad/Body aches; Muscle spasms; Headache; Tired; I had a 100.4 temperature for 2 days; This is a spontaneous report from a contactable consumer (reporting for herself). A 52-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unspecified indication. On 30Jan2021, the patient stated that "I slept all day, I could not eat, I could not get out of bed, I hurt so bad and has body aches, muscle spasms, headache, tired and I had a 100.4 temperature for 2 days." The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Nov2020. The outcome of the events was unknown. Information about lot/batch number has been requested.
52 2021-03-02 tingling Unable to move arm the day after. Had to get help getting dressed. Tingling feeling in arm, similar... Read more
Unable to move arm the day after. Had to get help getting dressed. Tingling feeling in arm, similar to how a body part feels if it had fallen "asleep". Tingling feeling ended March 2nd. Arm still feels tender.
52 2021-03-03 numbness An hour after my shot my left check was numb, lower left eye numb, left ear numb and left side of my... Read more
An hour after my shot my left check was numb, lower left eye numb, left ear numb and left side of my tongue is numb. It is still numb as I type this.
52 2021-03-03 seizure, unresponsive to stimuli About 10 mins after vaccination patient stated she wasn't feeling well. When pharmacist went to chec... Read more
About 10 mins after vaccination patient stated she wasn't feeling well. When pharmacist went to check on the patient she was seizing. 911 was called. Patient's eyes were fluttering and unresponsive, but breathing. Patient came in and out of seizure a few times. 1 full body seizure about 20 to 30 seconds. Patient was laid on the ground on her side till paramedics arrived. She was then taken by ambulance.
52 2021-03-04 difficulty speaking, feeling cold At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021... Read more
At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021) and went to EMT observation area. At approximately 1210, patient informed EMT that she was not feeling well. Patient was given the zero gravity chair to sit in. Per EMT, patient c/o fast heart beat. EMT took vitals and assessed patient: BP systolic of 128, HR 88, pupils equally reactive, LOC X4, skin warm, RR of 8. Per EMT, patient was anxious and complaining of discomfort from occipital area of her head and nape. Per EMT, patient was instructed to do deep breathing exercises and patient was given some ice to initiate vagal response. Approximately 15-20 mins later, patient complained that she was not feeling well. At 1235 EMT came over to lead RNs stating that she was having difficulty getting an accurate BP reading due to the lack of having the proper size of BP cuff onsite. RN used personal BP cuff to take patient's vitals. Per RN, At 1238, patient's BP was 170/100, HR 88, RR 12, regular breathing. Per RN, Patient c/o swollen tongue, throat itchiness, and feeling cold, patient's skin showed visible cold urticaria. After assessment, RN instructed RN to call 911. EMT gave report to 911 operator. After the medics were on their way to site, Patient insisted needing to go to the bathroom to urinate, RN and EMT assisted patient to the bathroom. Patient was ambulatory. At 1244 Fire paramedics and AMR arrived. Patient relayed to medics that her tongue is swollen, that she is feeling itchiness in her throat, and that she has a raspy voice. Medics gave patient Benedryl IM in L arm at 1248. Patient refused to be transported to a hospital per Medics recommendation. Patient signed documents declining further medical care. Patient was instructed to call 911 for any difficulty breathing and any throat swelling. Medics and AMR left at 1258. At 1300 niece came from parking lot to assist patient to go to her car to go home.
52 2021-03-04 hot flush Hot flashes multiple times a day since the date of vaccination
52 2021-03-04 numbness, tingling About 1 hour after vaccine I experienced a severe headache, low grade fever and chills. Two hour af... Read more
About 1 hour after vaccine I experienced a severe headache, low grade fever and chills. Two hour after injection I experienced a sudden onset of sever tingling and numbness in my left foot, leg, arm and hand which rapidly got worse. I had trouble stepping on the foot and walking. I decided to rest for the remainder of the day and called my primary care physician the following day. I never received a call back from her as promised and called again by end of day around 5pm CT to be told by the front desk to go to the ER. I held off from doing so for financial reasons and decided to make an appointment with an neurologist instead. Today (day 3 after the vaccination my symptoms are still present but have not worsened). I am still very concerned to potentially develop paralysis or GBS and therefore wanted to report the issue.
52 2021-03-04 numbness Episodes of unilateral facial numbness and tingling. Occurred in 3 separate episodes: First one bein... Read more
Episodes of unilateral facial numbness and tingling. Occurred in 3 separate episodes: First one being 30 minutes after administration of vaccine, 2nd one 8 days later, and 3rd one 10 days later. Each episode lasted about 5-10 minutes. Also reports constant pressure behind both eyes.
52 2021-03-04 muscle spasms PATIENT REPORTED FEELING DIZZY AND LIGHT-HEADED WITHIN TEN MINUTES OF RECEIVING VACCINE. SHE FELT NA... Read more
PATIENT REPORTED FEELING DIZZY AND LIGHT-HEADED WITHIN TEN MINUTES OF RECEIVING VACCINE. SHE FELT NAUSEATED AND STATED SHE FELT LIKE SHE DID WHEN SHE HAD AN ALLERGIC REACTION TO A BEE STING THAT REQUIRED AND EPI-PEN. WE BEGAN ASSESSING THE PATIENT FOR ANAPHYLAXIS. WE GAVE DIPHENHYDRAMINE 50 MG ORALLY AND MONITORED HER HEART RATE AND BLOOD PRESSURE. HER BLOOD PRESSURE AND HEART RATE STAYED WITHIN NORMAL RANGE FOR THE NEXT 45 MINUTES. SHE REPORTED NO ANGIOEDEMA OR ANY OTHER SYMPTOMS OF ANAPHYLAXIS. WE ALSO ADMINISTERED FAMOTIDINE 20 MG TABLET. SHE CONTINUED TO DO WELL AND DID NOT EXHIBIT ANY OTHER SIGNS OF ANAPHYLAXIS. AFTER 45 MINUTES OF MONITORING THE PATIENT WITH SYMPTOMATIC QUESTIONS FOR ANAPHYLAXIS, MONITORING HER BLOOD PRESSURE AND HEART RATE, AND WITH NO OTHER SIGNS OF ANAPHYLAXIS, THE PATIENT WAS RELEASED FROM OBSERVATION. SHE REPORTED TO OUR PHARMACY ON 3/5/21 THAT SHE HAS CONTINUED TO HAVE SEVERE MUSCLE CRAMPING, SOME NAUSEA AND OVERALL FATIGUE. I COUNSELED THE PATIENT TO CONTINUE TO MAKE SURE SHE CONTINUES TO STAY WELL HYDRATED. SHE CONSULTED WITH MD AND HE ADVISED HER TO STAY HYDRATED. SHE ALSO TOOK PREDNISONE PRESCRIBED FOR A PREVIOUS KNEE INJURY, THAT THE PATIENT REPORTED.
52 2021-03-04 restless legs syndrome she was very annoyed the next day; felt like the first time that like she got it an accident; feelin... Read more
she was very annoyed the next day; felt like the first time that like she got it an accident; feeling terrible; Restless leg syndrome/same thing before, but this hurts a lot worse, and it not going away; Restless leg syndrome/same thing before, but this hurts a lot worse, and it not going away; Fatigue; Her joints are hurting her/Fatigue/same thing before, but this hurts a lot worse, and it not going away; Cold chills; didn't get very much sleep; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE/PFIZER COVID SHOT; lot number: EL1284; expiration date: unknown) at vaccination age of 52-year-old via an unspecified route of administration in the left arm on 11Jan2021 at a single dose for prevention, she works in a hospital (covid-19 immunization). Medical history included seasonal asthma, cross fit (exercise adequate), and paleo and keto eating, thyroid is giving her problem, menopause. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE/PFIZER COVID SHOT; lot number: EH9899) at vaccination age of 52-year-old via an unspecified route of administration on 22Dec2020 at a single dose for prevention, she works in a hospital (covid-19 immunization) but got sick and was nauseous, flu like symptoms, restless leg syndrome, fatigue, joints are hurting her, she doesn't feel like doing crap and is miserable everyday, threw up, felt like she was in a car accident, that is how bad she felt, cold chills and anger. Concomitant medications included fish oil (OMEGA 3), ascorbic acid (VITAMIN C), Apple Cider Vinegar, thyroid medicine and vitamins. She reported that she took the second shot 11Jan2021 (to this day), she still has restless leg syndrome, fatigue, and her joints are hurting her. She had the same thing before, but this hurts a lot worse, and it not going away. She is taking Turmeric, everything, and everyone says to just keep taking Tylenol or Advil but she can't keep taking it because now it was upsetting her stomach, or like arthritis medicine, she is taking Omega 3 and vitamins. She added that she went to take the second shot next time, and all hell broke loose. That night (11Jan2021), she noted her joints were starting all over again, and she had restless leg syndrome, cold chills and everything, so she went to bed. she didn't have Benadryl, so she got up, and that night took Tylenol, she didn't get very much sleep, and she was very annoyed the next day (12Jan2021). She felt like the first time that like she got it an accident, feeling terrible that night, and she can lay on the couch to relax but with the restless leg syndrome, and her joints all day long. She just went yesterday to buy Advil Arthritis, and she never had arthritis before or anything. She mentioned that the restless leg syndrome outcome depends, sometimes it is better than other time, as for the joint pain, it was not improving, she is so aggravated about that, she is not feeling 100%, people look at her and say she doesn't look like she feels good (she doesn't) and she is ready to bite their heads off since she is very active, always in the gym or something. She started Turmeric since she is desperate, this has been going on since 11Jan2021, anything she is doing now is not doing anything. She does not know what to do as every doctor will say maybe she should see this doctor, but she didn't feel like this before this shot. She was tired of feeling this way, she didn't feel this way before the shot, and if anyone met her, they know it. The outcome of the event restless leg syndrome was recovering, arthralgia was not recovered while the outcome of the other events was unknown.
52 2021-03-04 restless legs syndrome aggravated and upset; she is angry; is miserable everyday/ felt like she was in a car accident, that... Read more
aggravated and upset; she is angry; is miserable everyday/ felt like she was in a car accident, that is how bad she felt; cold chills; she runs low like 96.6 to 96.8 and she took her temperature/ she was 95.5; joint pain/joint hurting; restless leg syndrome; fatigue; she got sick; nauseous; threw up; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included seasonal asthma diagnosed when she was a child and has a rescue inhaler she only uses once in a while if she needs it; she stated her thyroid was giving her problem, she takes a thyroid medicine; and stated weight was thanks to menopause. Concomitant medications included ascorbic acid (VITAMIN C), fish oil (OMEGA 3), and curcuma longa (TURMERIC). The patient reported that she was aggravated and upset on an unspecified date. She reported that she was not feeling bad before taking the shot and nobody was telling her what to do about it. She was asking what she should do about her symptoms of joint pain, restless leg syndrome and fatigue after getting her first vaccination on 22Dec2020. She was crying and stated that her boss can't tell her anything, she doesn't want to go to her doctor because, what was he going to tell her. She doesn't want to waste a copay. She reported taking Advil and Tylenol for her joint pain without relief and asked what else she should do. She stated she wanted directions, she doesn't want people reading off of a card. She stated she shouldn't have to pay a copay and she doesn't want more medicine to mask her symptoms, she wanted an answer. Additionally, the patient was calling about Pfizer COVID shot, she took first dose 22Dec2020, had a reaction, 35 minutes after she sat for 30 minutes, she works at a hospital, and she walked out to her car, she got sick and nauseous, then after the shot, she had flu like symptoms that lasted, and the next day was terrible, it lasted another week and a half, then she took the second shot 11Jan2021, to this day, she still has restless leg syndrome, fatigue, and her joints were hurting her. She had the same thing before, but this hurts a lot worse, and it was not going away, she was taking Turmeric, everything, and everyone says to just keep taking Tylenol or Advil but she can't keep taking it because now it was upsetting her stomach, or like arthritis medicine, she was taking Omega 3, vitamins, she was 52 years old, she does Spartan races, Cross fit, she does paleo and keto eating, if one looks at her they wouldn't know she was 52, and she was hurting everyday and doesn't know what else do to, and doctors weren't knowledgeable, she doesn't want a stupid answer. She called work, the CDC knows about it, now VAERS, and they said to call Pfizer, when she calls her doctor she doesn't want to pay a copayment and get an idiotic answer. She got this because she works at a hospital and she was trying to protect herself and everyone else, she doesn't like feeling this way, it was to the point she was getting angry, not at Pfizer, but she gets up and runs, with her dog, she was busy all the time, she has 3 boys in the military, and she meets up to do obstacles with them, but she doesn't feel like doing crap and was miserable everyday. She was a CNA in nursing school. She doesn't know if she even wanted to see her doctor, she doesn't want to get an idiotic answer. She hasn't seen him in while, she switched insurance, been primary for years. Stated this was her first day speaking to DSU before she decides what else to do after this, she was angry. Stated about 35 minutes after the first shot, after 30 minutes they said she could go, she said ok, she walked out to her car, was nauseous and threw up and didn't eat that morning, and the next day, she felt like she was in a car accident, that was how bad she felt, she had cold chills, flu like stuff that night before, she runs low like 96.6 to 96.8 and she took her temperature, she got in a blanket and went to bed that night, she was 95.5, and didn't bother taking another temperature, she took a bunch of Advil and went to bed, and Benadryl to go to sleep. This all started on 22Dec2020, and it took about 2 weeks, she just had joint pain, not like now, but those days she didn't feel good, but by the third week she was ok, and she went to take the second shot next time, and all hell broke loose. The second shot was 11Jan2021, and that night it she noted her joints were starting all over again, and she had restless leg syndrome, cold chills and everything, so she went to bed, she didn't have Benadryl, so she got up, and that night took Tylenol, she didn't get very much sleep, and she was very annoyed the next day, she felt like the first time, that like she got it an accident, feeling terrible, that night, and she can lay on the couch to relax, but with the restless leg syndrome, and her joints all day long, she just went yesterday to buy Advil Arthritis, and she never had arthritis before or anything. Restless leg syndrome depends, sometimes it was better than other time. Joint pain was not improving, she was so aggravated about that, she was not feeling 100%, people look at her and say she doesn't look like she feels good, she doesn't, and she was ready to bite their heads off, she was very active, always in the gym or something, she has 3 kids in the military, and was always meeting up with them to do military runs and just this was ridiculous. Stated she took a picture of the vaccine card, as she sent it to a few people. This was definitely the Pfizer vaccine, she has told many people, many people know do not take this, she was so irritated, it's not even funny. The case was reported as non-serious. The outcome was not recovered for the events joint pain, restless leg syndrome and fatigue; and unknown for the rest of the events.
52 2021-03-04 seizure Systemic: Seizure-Medium
52 2021-03-05 pain in extremity Headaches that would come and go Fast heart beat Dizziness Heartburn that came and went twice Sore ... Read more
Headaches that would come and go Fast heart beat Dizziness Heartburn that came and went twice Sore calf Sore quad Sore arm (injection site) Sore neck left side. Fatigue
52 2021-03-06 feeling hot After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With i... Read more
After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With in a minute my throat got scratching and had a hard time Swallowing. My Tongue Swelled and my lips felt Numb.A Medic doc was called over to me. I was immediately taken to a tent with other Doctors. The doctor immediately gave me a Epipen in my right upper thigh. With in a few minutes EMS was there they tried to put a IV IN me but was unsuccessful. The EMT gave me a shot of Benadryl in my right arm. EMT rushed me to Emergency room. At the ER they put an IV in and gave me Dexamethasone and Pepcid. I was closely watched and was released after around 5 hours.
52 2021-03-07 weakness, flushing weakness, flushing. Evaluated by EMS-Cleared
52 2021-03-07 bell's palsy Bells Palsy, treatment started 3/8/21 with prednisone
52 2021-03-07 bell's palsy Bell's Palsy
52 2021-03-07 burning sensation A few days after vaccine I started having pain, burning in my right wrist, shoulder, and elbow. Now ... Read more
A few days after vaccine I started having pain, burning in my right wrist, shoulder, and elbow. Now having severe burning and pain in both wrists, elbows, and shoulders. Difficulty picking up items, grasping, pushing up. Have never had these symptoms. Now about 5 weeks since vaccine and still remains. Have not seeked medical attention. Wanted information in data base in case it is common.
52 2021-03-07 hot flush Progress Notes Family Medicine Pt called to follow up on covid-19 vaccine done on 02/26/21. She ... Read more
Progress Notes Family Medicine Pt called to follow up on covid-19 vaccine done on 02/26/21. She reports she felt a little run down on Saturday (the following day of the injection). She feels well today. Denies any further questions or concerns. Pt is appreciative of phone call. Progress Notes Family Medicine Attempt to call patient for follow up via phone. No answer. Progress Notes Family Medicine Cosigned by: Expand AllCollapse All STORMONT VAIL COVID VACCINE CLINIC DOB: 2/1/1969 Date: 2/26/2021 a 52 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience feeling flushed. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH: anxiety/panic attacks. HTN on amlodipine since 3-4 months. 10 mg. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, dizziness and headaches Feels flushed and hot Not diaphoretic: Previous Reactions: none. States she was anxious prior to her visit today about the vaccine. Objective Vitals Vitals: 02/26/21 1326 02/26/21 1336 02/26/21 1339 02/26/21 1351 BP: (!) 155/96 (!) 187/121 (!) 156/97 (!) 154/97 Patient Position: Sitting Pulse: (!) 109 99 Resp: (!) 24 SpO2: 100% 100% Physical Exam Constitutional: General: She is in acute distress (anxioius affect). Appearance: She is obese. Cardiovascular: Rate and Rhythm: Tachycardia present. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Tachypnea (slightly 24) present. Comments: Pt asked to remove mask to reduce her hyperventilation. Neurological: Mental Status: She is alert. Psychiatric: Attention and Perception: Attention normal. Speech: Speech normal. Behavior: Behavior normal. Thought Content: Thought content normal. Cognition and Memory: Cognition normal. Comments: Tearful and slightly anxious Assessment/Plan Treatment included: water, snacks and ice pack Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) (elevated blood pressure) Pt observed approx 30 minutes. Pt improved in symptoms after rest, food, water and ice pack. Her bp was coming down. HR and RR normal. Pt felt better. She wanted to leave as staying here is making her more anxious. Recommended that she monitor her bp at home. If persists to be elevated of 140/90 that she follow up with her pcp. Pt voices understanding. Pt has co-worker here with her whom walked out with her.
52 2021-03-07 numbness, weakness, difficulty speaking, feeling hot, tingling 03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint,... Read more
03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint, weak, rapid pulse, heart skipping, numbness and tingling in fingers and toes, ringing and heat in ears, rash/redness on chest, neck and ears, intermittently "seeing stars", extremely dry mouth, hoarseness in voice and dry cough when speaking. Made my way to my sister's dental office nearby, where approximately 1 hour later, she gave me 50 mg of Benadryl and 99% Oxygen 2L/min via nasal cannula. BP 131/82, pulse 81, blood sugar 126 ml/dl. When not resolved after approximately 1.5 hours, I proceeded to the hospital Emergency Room. They did an EKG (normal), gave me famotidine and a steroid and observed me for a couple of hours. Most symptoms had subsided and was released at approximately 2:30 or 3:00 p.m.
52 2021-03-07 pain in extremity Patient reported mild fatigue and arm soreness until the following afternoon when her left eye bega... Read more
Patient reported mild fatigue and arm soreness until the following afternoon when her left eye began to burn which progress to the right eye. Later in the evening the left upper eye lid began to swell extending into the lower lid along with right upper lid swelling. She contacted medical through our COVID hotline where I was notified around 9 pm Thursday night ( 03/04/2021). She denied an respiratory or cardiac symptoms and was mostly concerned about the periorbital edema. She did not feel she needed to go to the hospital. She was advised to take Benadryl 50 mg every 6-8 hours and apply cold packs. A follow up call was made by me at 07:30 am on Friday and was instructed to contact her PCP. Later that day she called me indicating she went to Urgent Care and was seen by Dr.
52 2021-03-08 burning sensation, tenderness Arm burns and is still sore to touch
52 2021-03-08 pain in extremity Right arm pain, headache, fatigue
52 2021-03-08 tenderness, pain in extremity I had slight tenderness from the 1st shot still and received the 2nd dose in the same arm. It hurt q... Read more
I had slight tenderness from the 1st shot still and received the 2nd dose in the same arm. It hurt quite a bit. My arm started hurting right away. Over the course of the afternoon, I felt achy and tired. I went to bed about 9:30 pm. During the night I suffered nausea, headache (on the left side), bad chills and then sweats. Fever of 102.4. Arm so sore can even sleep on it. By the am, 10:20 am, still massive fatigue, aches, fever (still between 100.9 and 102.4), chills and earache. .
52 2021-03-09 weakness, pain in extremity, tingling R hand pain, redness, swelling, weakness, tingling
52 2021-03-09 numbness, feeling hot about 2 minutes after receiving the vaccine i felt a heatwave starting at left arm going through my ... Read more
about 2 minutes after receiving the vaccine i felt a heatwave starting at left arm going through my whole body, with dizziness and and a feeling of panic. was about to ask for water but panic feeling subsided after roughly one minute. slight dizziness remained. 15 minutes later I felt a slight numbness in my face and right hand
52 2021-03-09 muscle spasms she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at ... Read more
she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at the injection area; severe back spasms in the thoracic and lumbar; made a different in the vision, it was throbbing; back pain; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL0140), intramuscular on 04Jan2021 at single dose at left arm for covid-19 immunization. Medical history included diabetes (diagnosed six years ago. Her last A1C was 6.1 in Dec2020), chronic edema since her last child was born 26 years ago. Concomitant medications included ongoing furosemide (LASIX), ongoing potassium, ongoing omeprazole (PRILOSEC), ongoing metformin, and paracetamol (TYLENOL). Caller received the Pfizer-BioNTech COVID-19 Vaccine first dose on 04Jan2021 and second dose on 27Jan2021. Caller reported to have experienced back pain 2-3 days after the first dose, and a sharp stabbing back pain with moist cough for almost a month now after the second dose. Caller was diagnosed with COVID-19 in between. With the first vaccine she had headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given diclofenac (VOLTAREN) and cefixime (FLEXERIL). She was taking 1 gram of paracetamol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. Seriousness criteria for back pain, it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor; for event arm pain at the injection area, gripping was not easy and moving her arm was painful. She was left handed. Heat worked better than ice. Ice made things worse; for event headache, made a different in the vision, it was throbbing. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of paracetamol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She had been taking 1000mg paracetamol three times a day and now she was taking it two times a day. She was taking cefixime at bedtime because she can't stay awake when she took it. She can't take it and work. She had missed work because of this. She was taking diclofenac twice a day. Patient didn't have the first bottle of paracetamol she used because she had gone through it. Current bottle of Tylenol was the generic, SunMark Acetaminophen. She had to get her glasses to read the lot number. It was made by (Pharmacy name), Lot number: OLE2349B, expiry: Sep2022. She didn't feel like the medication she took were relevant because she had been taking them for a very long time. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021. She got the results of her PCR test on 13Jan2021. Outcome of event back pain was not recovered, outcome of events headache, arm pain at the injection area and severe back spasms in the thoracic and lumbar was recovered in 2021, and outcome of other events was unknown. Relatedness of drug to reaction(s)/event(s): Events headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar: source of assessment: primary source reporter; Method of assessment: global introspection; Drug result: Related.; Sender's Comments: Event back pain represents an intercurrent medical condition and unrelated to bnt162b2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-03-09 muscle spasms glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side... Read more
glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side; vaccines were given in the left arm because she was left-handed; Back pain; spasms; fever; she felt like the inside of her eyes were on fire; She had a moist cough; spine pain; nausea; vomiting; She had numbness and tingling around the outside of mouth; She had numbness and tingling around the outside of mouth; She had pain in the arm at the injection site; knees would buckle; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) at single dose on 27Jan2021 via an unknown route in left arm for Covid-19 immunization. She was diagnosed diabetes six years ago (as of 23Feb2021), and her last A1C was 6.1 in Dec2020, had chronic edema since her last child was born 26 years ago. Concomitant drugs included furosemide (LASIX) 400 mg twice daily, potassium 10 meg three times daily, omeprazole (PRILOSEC) 40 mg once daily, and metformin hydrochloride (METFORMIN ER) 1000 mg twice daily, all ongoing. She did not feel like the medication she takes are relevant because she had been taking them for a very long time. Historical Vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) intramuscular injection in left arm on 04Jan2021 for Covid-19 immunization and experienced back pain, diagnosed with COVID in between the first and second vaccine, headache, arm pain at the injection area, severe back spasms in the thoracic and lumbar (AER 2021200627). Patient experienced back pain 2-3 days after the first dose, headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given Voltaren and Flexeril. She was taking 1 gram of Tylenol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. The reporter assessed headache, arm pain at the injection area, back pain, severe back spasms in the thoracic and lumbar were related to suspect vaccine. After the 2nd dose of the vaccine, patient experienced back pain in Jan2021, sharp, stabbing, crushing pain and spasms in Jan2021, fever for a couple of days in Jan2021, knees would buckle in Jan2021, glands were swollen and when swallows, sharp pain on one side on 09Feb2021, felt like the inside of her eyes were on fire in Jan2021, moist cough in Jan2021, spine pain in Jan2021, nausea and vomiting in Jan2021, numbness and tingling around the outside of mouth in Jan2021, pain in the arm at the injection site in Jan2021, injection site was about a silver dollar size and was red and warm to touch in Jan2021. The event clinical course was as follows: The second dose was given on 27Jan2021. She was getting over COVID and had to wait until the 27Jan2021 to get second dose. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021 with results of her PCR test on 13Jan2021. She was diagnosed with COVID in between the first and second vaccine due to an exposure not the vaccine. At hour 25 after receiving the second dose symptoms started. Severe back pain in the entire spine. It was sharp, stabbing, crushing pain and spasms. When the back would spasm her knees would buckle. She had a fever for a couple of days. 102 fever and she felt like the inside of her eyes were on fire. She has never had that before. She had a moist cough and still has a moist cough. The spine pain was better, but it is not gone away yet. Normally she does not have back pain. At first the pain was an 8 out 10 now (as of 23Feb2021) it was 5 out of 10. Also had nausea and vomiting. She had numbness and tingling around the outside of mouth. That lasted for two days. She had pain in the arm at the injection site. The injection site was about a silver dollar size and was red and warm to touch. She had pain at the injection site and pain in the arm. Both vaccines were given in the left arm because she was left-handed. She thought she would be using that arm more. She did go to Urgent Care after the second dose as well. They gave her a shot of Toradol and another prescription for Voltaren twice a day and Flexeril at bedtime because she can't stay awake when she takes it. She has missed work because of this. The back pain and cough was almost a month now (as of 23Feb2021). She reported no matter what she did she did not get it to go away. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of Tylenol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She has been taking 1000mg Tylenol three times a day and now she was taking it two times a day. She used Tylenol and generic, SunMark Acetaminophen (Lot number: OLE2349B, expiry: Sep2022). Regarding seriousness of headache, made a different in the vision. It was throbbing. for back pain: it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor. for arm pain at the injection area: gripping was not easy and moving her arm was painful. She is left handed. Heat worked better than ice. Ice made things worse. for cough: it had not been disabling. it was irritating because it had been almost 30 days. She knows it was different than the COVID cough because it was moist and when she had COVID it was a dry cough. Regarding seriousness of nausea and vomiting: it was debilitating and she couldn't go anywhere because she was throwing up with every move she made. The pain made it worse. The reporter assessed moist cough, nausea and vomiting, arm pain at the injection area were related to suspect vaccine. No investigation assessment performed. Outcome of fever, inside of her eyes were on fire, pain in the arm at the injection site was resolved. Outcome of back pain, moist cough was not resolved. Outcome of spine pain was resolving. Outcome of the other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the back pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including spine CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-03-09 tremor 10 hours after vaccination experience severe shaking, fever of 102.6 Took 2 (500 mg) Tylenol. Fever ... Read more
10 hours after vaccination experience severe shaking, fever of 102.6 Took 2 (500 mg) Tylenol. Fever kept climbing to 104.5 Took 25 mg of Benadryl for red color of face and small rash on abdomen. Placed call to Dr. Advised every 8 hours Tylenol (1000mg) and cycle with Ibprofen- 2 (200mg). Fever remained at 104 till morning, then 103.1. Fever down for 2 hours and spikes to 104. Took cold bath, reduced fever to 102. Chills, violent shaking a headache behind eyes, very dehydrated. Drank Gatorade and with fatigue slept off and on for 48 hours. Fever finally down by 03/10/2021 to 98.9 with mild headache. Did not have any body or muscle aches during this event.
52 2021-03-10 pain in extremity Employee received the first dose of the COVID 19 vaccine on 1/22/2021 in her left deltoid. At the ti... Read more
Employee received the first dose of the COVID 19 vaccine on 1/22/2021 in her left deltoid. At the time she received the first dose she only had a sore left arm. Two days after receiving the vaccine she experienced shooting, sharp pain when she tried to lift her left arm forward or to the side. Pain was 8 out of 10. She saw her primary care doctor, on 2/1/21. He advised her to wait to see if the symptoms got better. She continued to have decreased range of motion and shooting, sharp pain when she moved her left arm. She saw an orthopedic doctor on 2/10/2021 who did an x-ray and MRI. The MRI showed calcification of the bursa in her left shoulder. This doctor recommended cortisone injections. Employee received the first dose of the COVID 19 vaccine on 1/22/2021 in her left deltoid. At the time she received the first dose she only had a sore left arm. Two days after receiving the vaccine she experienced shooting, sharp pain when she tried to lift her left arm forward or to the side. Pain was 8 out of 10. She saw her primary care doctor, on 2/1/21. He advised her to wait to see if the symptoms got better. She continued to have decreased range of motion and shooting, sharp pain when she moved her left arm. She saw an orthopedic doctor on 2/10/2021 who did an x-ray and MRI. The MRI showed calcification of the bursa in her left shoulder. This doctor recommended cortisone injections, but the employee did not want to do that. On 3/10/2021 she saw an orthopedic surgeon who specializes in shoulders. Drtold the employee she had a shoulder injury related to vaccine administration (SIRVA) because the needle from the COVID 19 vaccine went into the bursa sac in her left shoulder. He is recommending physical therapy for treatment. Employee reports currently the shooting, sharp pain is gone and now there is a dull ache in her shoulder. The employee states she received the second COVID vaccine, with a smaller needle, with no adverse effects.
52 2021-03-10 tremor, feeling cold At 7:00am I had the chills, shaking so bad, could not get warm, vomiting, continued nausea , diarrhe... Read more
At 7:00am I had the chills, shaking so bad, could not get warm, vomiting, continued nausea , diarrhea and headache and continue ribgibg4in my ears into Thursday and
52 2021-03-11 breast pain pt states that she started itching between the left shoulder and left breast. As she scratched her ... Read more
pt states that she started itching between the left shoulder and left breast. As she scratched her breast she felt a small bump and noticed a brown spot. She contacted her OB/GYN via portal to let her know that about these symptoms. The Doctor advised her to see a Dermatologist. She contacted her once again since she felt like something was wrong and was told again to see a Dermatologist. Pt saw Dermatologist on 3/4/2021 and was told it did not look skin cancer and ordered some cream. Pt let Dr. know that she had taken the vax recently and that she also has breast implants. The Doctor did a small exam but did not feel a lump, but this doctor is not an OB/GYN. Pt went to an already scheduled mammogram on 3/11/2021 but they would not complete the annual exam since she was having pain issues so she was rescheduled for a diagnostic exam on 3/17/2021. Pt believes she has felt swollen lymph nodes under her left arm and has had intermittent pain for about 3 weeks now. The pain seems to move around from breast to her back.
52 2021-03-11 difficulty speaking Approximately 30 minutes after receiving the vaccination, the individual got out of her car and stat... Read more
Approximately 30 minutes after receiving the vaccination, the individual got out of her car and stated she felt her tongue swelling. There was a noticeable voice change, expiratory wheezing and pallor. BP 122/86, HR 84. At 10:10am, 0.5mL epinephrine was administered intramuscularly in the opposite deltoid, and EMS was called. Patient reported improvement in symptoms. EMS took over care of the patient, and transported her to the local hospital. She was discharged from the emergency room.
52 2021-03-11 feeling hot, weakness, pain in extremity Fever 102, Severe Chills, Feeling hot, Aches & Pains, Extreme Tiredness (thursday 3/11), Sore Arm w... Read more
Fever 102, Severe Chills, Feeling hot, Aches & Pains, Extreme Tiredness (thursday 3/11), Sore Arm where it was difficult to lift (only lasted 4 hours), Extremely weak unable to reach for my cell phone, Headache, Very bad neck pain, Feeling like I had the flu, Sweating, nauseous and couldn't eat. Did not sleep at all Wednesday 3/10 night due to the aches and pains, could not get comfortable. Couldn't lie down or sit up comfortably and barely able to stand. I slept most of the day on Thursday 3/11 and was so tired I would fall asleep in mid sentence. Took ibuprofen 200mg and helped SLIGHTLY and wore off very quickly. Couldn't wait to get to the four hour mark to take more. I was so sick my husband wanted to take me to the ER. I woke up on Friday 3/12 feeling back to myself. I was told by my Rheumatologist to stop take HP Acthar Gel and Xeljanz for one week after the vaccine.
52 2021-03-11 numbness, tingling Receive 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of... Read more
Receive 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of the recommended 1.8 ml normal saline. Tingling/numbness on same arm as injection. Reports feeling odd. Observed and symptoms resolved within 20 minutes. Released home
52 2021-03-11 numbness and pain in extremities, tingling, numbness 1. TINNITUS (ringing in the ears) - bilateral, persistent: both ears, continuous ringing, high-pitch... Read more
1. TINNITUS (ringing in the ears) - bilateral, persistent: both ears, continuous ringing, high-pitched sound. began intermittently, then progressed to continuous. 2. PERIPHERAL NEUROPATHY (tingle/numbness) - bilateral, hands and feet: began intermittently, then progressed to continuous.
52 2021-03-12 feeling cold, tremor 10 minutes after the shot was given, I felt a release and my heart rate increased, I went to a nurse... Read more
10 minutes after the shot was given, I felt a release and my heart rate increased, I went to a nurse and let them know I was having a reaction, and they took me to a bed, I had brought my Benadryl with me and took 5 ml, I became very cold and began to shake, some shortness of breath, tongue became thick feeling, I am not sure of the time schedule, but I also had my Cromolyn and took 5 ml, I was still having problems after an hour and I took 5ml more of Benadryl and cromolyn, after about 2 hours in the covid area I felt good enough to go home
52 2021-03-12 flushing, pain in extremity 15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my f... Read more
15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my face was also flushed and the inside of my mouth (mostly roof of my mouth) and lips were itchy/tingly. Then, I took 2 Zyrtec 10 mg. as instructed by my allergist if I had a reaction. Within an hour, the flushing and itchiness were gone. 2 days later - had strange pain, swelling, and warmth in upper left shin below knee. Worried about possible blood clot, I took 2 baby aspirin. Pain and swelling went away. Not sure if related to vaccine but unaware of anything else that could have been different.
52 2021-03-12 pain in extremity, burning sensation Sore arm day after - no other affect. 9 days later I started to get rash on face. but day 10 , I... Read more
Sore arm day after - no other affect. 9 days later I started to get rash on face. but day 10 , I had a full allergic reaction. burning, itching face. I went to my dermatologist and he believes it was a delayed reaction to the vaccine. Nothing new was introduced to my world. I started a regime of Prednisone . Day 11 the redness was gone but residual effects were apparent Day 12 my skin was flaky but otherwise normal
52 2021-03-12 tingling, pain in extremity One week after vaccine woke with large round, very itchy rash at injection site. Area was swollen an... Read more
One week after vaccine woke with large round, very itchy rash at injection site. Area was swollen and warm with a very small hard area directly at injection site. It was very itchy for about 8 hrs and then it was only sporadic at best. The rash was very red at beginning but has faded continually since. The area is a very distinct oval or circular shape, approx. 4 inches in diameter. It is almost hard to call it a rash as the itchiness, swelling and "prickly" type skin were very short lived, 2-4 days, but the discoloration is still very distinct although faded considerably since the first appearance. I did have moderate headache and arm soreness with the first vaccine, short lived. With the second dose I had headache and then extreme axillary and neck soreness on second day. The rash did not appear until one week after the 2nd dose. It has been approx one month and the 4 inch "rash" is still apparent but faded .
52 2021-03-13 weakness Headache, chills, nausea, vomiting, aches and pain, severe pain in kidneys, eye pain, weakness, loss... Read more
Headache, chills, nausea, vomiting, aches and pain, severe pain in kidneys, eye pain, weakness, loss of appetite,
52 2021-03-13 discomfort Symptoms Not feeling right -within 5 minutes Heaviness in appendages-15 minutes little dizziness 20 ... Read more
Symptoms Not feeling right -within 5 minutes Heaviness in appendages-15 minutes little dizziness 20 min Heart Rate increase 25 min Pressure on chest 25 minutes Severe shivers-30 minutes
52 2021-03-13 feeling cold, tremor This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265]. Both va... Read more
This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265]. Both vaccines gave me a reaction, and both around the same time the next morning. My reaction to my 1st vaccine included slight fever, aches, and chills. Both doses were administered around 3:30pm and reaction was approximately 10:30-11am the next morning. On this 2nd dose, roughly 40 minutes after waking from sleep, I became mildly nauseas. I sensed I would vomit, so I sat down on the commode with a bucket in front. I started getting the sweats, got very cold, and my arms starting shaking. I started to feel the room spin, saw big black dots, and after banging on the wall to alert my husband something was happening, I fainted and passed out cold. My husband saw me fall face down, and after waking me, I was in a panic, did not know where I was, or how I was on the floor. I passed out a 2nd time, at which point, my husband was able to get me to the car and he took me to the local hospital. I was incoherent on the car ride, moaning, and not knowing what was happening. My eyes remained closed until I was wheeled into the emergency area and they asked me my name. I was taken to a private room, where they hooked up a blood pressure cuff, an oxygenator on my finger, and took several viles of blood. I was then taken to the cat scan room for a brain scan, and several hours later, was given a chest xray. I remained in the room for approx 6 hours, where I was becoming more and more aware of where I was. I had not eaten/drank anything, except a cup of water. I had not used the lavatory. The PA came to me hours later stating all my tests came back negative, and they could not determine what happened, xrays and blood tests were good, and cat scan was good. He said that while they couldn't determine what happened, they would recommend a stay, so they can do more extensive testing. I contacted my husband via cell, told him what they said, and after another 1 1/2 hours, I made the decision to release myself as I was feeling more like myself again, albeit tired. I went home that evening, ate a small dinner, went to bed, and by 12 Noon the next day, I was fine again.
52 2021-03-13 muscle spasms, hot flush, pain in extremity Within an hour of shot, fever, dizziness, nausea, hot flashes, sleeplessness, body pain, arm pain, h... Read more
Within an hour of shot, fever, dizziness, nausea, hot flashes, sleeplessness, body pain, arm pain, headache, leg cramps, and feeling like it was the worst flu I've ever had (minus respiratory issues). On day 5, it started to lessen to general malaise and a slight headache.
52 2021-03-13 pain in extremity Very bad pain in left arm, swelling from shoulder to elbow, swelling in left leg from just below kne... Read more
Very bad pain in left arm, swelling from shoulder to elbow, swelling in left leg from just below knee to toes feels like my skin is going to split. Right side is fine.
52 2021-03-13 tingling, numbness Nausea, diarrhea, chills, tingling and numbness,in feet and hands, could not sleep, all within 24 ho... Read more
Nausea, diarrhea, chills, tingling and numbness,in feet and hands, could not sleep, all within 24 hours 48 hours tingling and numbness but not as severe, body aches, sore
52 2021-03-13 tingling Patient reports long history of taking ibuprofen/NSAIDS. After 2nd dose of vaccine 2/2/21 she took ... Read more
Patient reports long history of taking ibuprofen/NSAIDS. After 2nd dose of vaccine 2/2/21 she took took ibuprofen about 27-28 hours later on 2/3/21 due to aches/headache. She developed face/lip swelling and tingling. She was seen by provider via video visit and told she needed to be seen in person. She went to urgent care and was prescribed EpiPen PRN. On 2/22/2021 she was having some back-pain and took ibuprofen. About 1 hour later she developed same response with face swelling/tingling. She does feel her reaction is caused by the ibuprofen but she reports this being a new reaction since the vaccine since she routinely took ibuprofen prior to the vaccine.
52 2021-03-14 flushing feels like throat swelling, flushing, waited 15 minutes, cleared
52 2021-03-14 numbness, tingling Immediately after injection, patient felt tingling all the way down her arm after her vaccine was ad... Read more
Immediately after injection, patient felt tingling all the way down her arm after her vaccine was administered. She alerted a pharmacist about 15 minutes after her dose that her right hand felt numb. She waited an additional 15 minutes and said her hand felt better and she was comfortable leaving the vaccination site.
52 2021-03-14 migraine, hot flush Migraine, nausea, hot flashes, fever, high blood pressure, fatigue. Treated at ER, with benadryl, ib... Read more
Migraine, nausea, hot flashes, fever, high blood pressure, fatigue. Treated at ER, with benadryl, ibuprofen and something for nausea on Friday the 12th of March.
52 2021-03-14 pain in extremity Day of vaccine thru day 3 - tired, headache, both arms sore at same location as injection in left ar... Read more
Day of vaccine thru day 3 - tired, headache, both arms sore at same location as injection in left arm. Day 4 - present - both arms sore/achy at approximately same location as injection site.
52 2021-03-15 pain in extremity Shot received at 4pm 3/12. Sore arm evening of shot, very tired next 2 days and sore arm. Only sligh... Read more
Shot received at 4pm 3/12. Sore arm evening of shot, very tired next 2 days and sore arm. Only slight soreness in arm on 15th & 16th
52 2021-03-15 tremor, feeling cold, pain in extremity Unable to lift arm within 10 hours. In 18hrs was shaking and extremely cold. Had temp of 100.9. That... Read more
Unable to lift arm within 10 hours. In 18hrs was shaking and extremely cold. Had temp of 100.9. That lasted for 6 hours and transitioned to burning up. During this time I had severe pain in all joints from my neck to my hips. My fingers swelled as well. My legs felt fine and no headache. Tylenol and ibuprofen helped my fever but did not alleviate my pain symptoms. My shot was Friday evening. By sunday afternoon my fever was gone as well as the pain in all but my arm. But is was down to manageable.
52 2021-03-16 difficulty speaking Patient received vaccine at 12:30. Symptoms began at 14:00. She noticed a faint pink rash on both ... Read more
Patient received vaccine at 12:30. Symptoms began at 14:00. She noticed a faint pink rash on both arms and feels itchy all over. Her tongue feels numb, but not swollen. Her voice is hoarse. Her heart was racing initially, but that resolved quickly. She also felt short of breath for a few minutes, but that also resolved prior to her seeking medical care. She has numerous medication allergies and states this feels similar to a reaction she has when she is allergic to a medication.
52 2021-03-16 facial paralysis, numbness 5 hours after injection patient experienced numbness on right side of face as well as facial droopin... Read more
5 hours after injection patient experienced numbness on right side of face as well as facial drooping. This lasted about 2 hours. About 7 hours after injection patient experienced labored breathing, chills and body aches; these symptoms lasted for about 36 hours.
52 2021-03-16 feeling hot, pain in extremity Day 1 = Arm pain and body aches Days 2-4 = like a MS flair I have had before + itchy mouth MS flair... Read more
Day 1 = Arm pain and body aches Days 2-4 = like a MS flair I have had before + itchy mouth MS flair - lower right leg hot and tightness and a little weak both legs, but right was more severe Itch mouth got better with Benadryl. I had not issues breathing or swelling. It wasn't bad, just annoying. By day 5, I was back to normal.
52 2021-03-16 migraine I have to say my symptoms started with my first dose vaccine 12-18-2020, lot#: EH9899 and it has con... Read more
I have to say my symptoms started with my first dose vaccine 12-18-2020, lot#: EH9899 and it has continued on to my second dose vaccine. On 12-23-2020 after my first dose I started to have daily headaches. I received my second vaccine in 01-08-2021, also experienced daily headaches. I went to see my PCP on 02-19-2021 who referred me to a neurologist. I saw a neurologist on02-22-2021 and was diagnosed with occipital neuralgia and migraine headaches. I tried different medications but they have not yet worked. I also had a occipital nerve block with no improvement. My BP is high probably secondary to the pain and anxiety I experience from my daily headaches. Today I am still having the daily headaches.
52 2021-03-17 weakness patient became diaphoetic, pale, and reported feeling weak immediately after vaccination. Blood pres... Read more
patient became diaphoetic, pale, and reported feeling weak immediately after vaccination. Blood pressure 79/41 mmHg, heart rate 45-50 beats per minute. Patient reports not eating eating anything yet that day. On arrival to emergency department (ED) patient was awake, alert, and oriented. No respiratory, gastrointestinal, or respiratory symptoms noted. Administered diphenhydramine and IV fluids. Patient's symptoms and vital signs improved and discharged to home stable.
52 2021-03-17 feeling cold, hot flush, migraine After 24 hours of my vaccine at about 4pm the following day at my work, I started to feel like I was... Read more
After 24 hours of my vaccine at about 4pm the following day at my work, I started to feel like I was getting a cold, my face was hot. I went to the station to take my temperature, it was 98.4F and then I did a re-check 15 minutes later it was 97.2F. I was still feeling under the weather and left work a little before 5pm. I started to drive to the pharmacy when I got there I felt dizzy, I still went in and bought Tylenol cold and flu PM. When I got home, I still was feeling bad, I had severe headaches, migraines and also pain to base of my neck and my chest felt very heavy, like someone was sitting on top of me. I then went to bed early, was lying flat on my bed when I started to feel my heart, shaking my whole body. I felt really scared, these were strong palpitations. I then woke up around 3am, still having persistent headaches 10/10 pain level. I woke up because I could not sleep and went to my living room, still having chest pain and pain in my neck with headaches that did not go away. My BP in the morning was high for me was 132/96, then 133/98 and at 730am it was 137/100 with a pulse of 80. I went to the emergency room where I received IV medication, blood tests, triponents and EKG were performed which came back negative. After an hour of my iv medication, I still continued with headaches, neck pain and my blood pressure was still high. My doctor said that i had a severe reaction to the vaccine. I was discharged to go home after a few hours and I rested then I slowly started to fee better.
52 2021-03-17 flushing ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper... Read more
ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper chest/throat discomfort. TENT NOTE: PT. COMPLAINED OF TIGHTNESS IN UPPER CHEST AND FEELING FLUSHED. ASSISTED TO GURNEY AND ADULT EMERGENCY CALLED
52 2021-03-17 grand mal seizure Pt had a tonic clinic seizure in the observation area. Pt was brought to the ground and EMS called. ... Read more
Pt had a tonic clinic seizure in the observation area. Pt was brought to the ground and EMS called. Vital signs stable. Cold compress to forehead . Transported to hospital.
52 2021-03-17 numbness, tingling started with tingling, numbness, and redness around the mouth and face. quickly progressed to hives ... Read more
started with tingling, numbness, and redness around the mouth and face. quickly progressed to hives and difficulty breathing. EMS administered benadryl, solumedrol, and epinephrine and transferred to ER. She responded to treatment quickly and was discharge from the ER same day.
52 2021-03-17 migraine The day after vaccination I was sleepy and the next day I felt normal. On the third day that I start... Read more
The day after vaccination I was sleepy and the next day I felt normal. On the third day that I started to get the Migraines. It started on the left side. It was similar to my other migraines. It did not respond to my normal medication. I was nauseous but no aura. The Migraine lasted a week before I was headache free. I After the second dose of my vaccine I had the same pattern of Migraines for 5 or 6 days. I also had some head cold symptoms with the headaches after the second dose.
52 2021-03-17 migraine migraine within 24 hours of 2nd vaccine, migraine 4 days after 2nd vaccine, migraine 5 days after 2n... Read more
migraine within 24 hours of 2nd vaccine, migraine 4 days after 2nd vaccine, migraine 5 days after 2nd vaccine
52 2021-03-17 pain in extremity, muscle twitching Had the 2nd Pfizer Covid shot on 3/14/2021 around 5:30pm. Typical arm soreness and all body achiness... Read more
Had the 2nd Pfizer Covid shot on 3/14/2021 around 5:30pm. Typical arm soreness and all body achiness from 1am 3/14/21 til 3/16/21 morning. On 3/16/21 evening, right calf muscle started twitching a lot and feeling like it would cramp although it wasn?t painful. This happened throughout the day and night; slept with right leg raised on a pillow on 3/17/21 evening. Today, 3/18/21, right calf and leg feel better. Not sure if the muscle twitching and feeling like it would cramp (not painful, just uncomfortable; no swelling, no warmth on leg, no hard veins or arteries) was related to the shot.
52 2021-03-17 pain in extremity I received the Pfizer vaccine on Saturday March 6th. My arm was sore just at the injection site for ... Read more
I received the Pfizer vaccine on Saturday March 6th. My arm was sore just at the injection site for 2 days and that went away. Tuesday, the 15th, 9 days after receiving the injection, I woke up and my whole arm hurt from my shoulder to my wrist. I thought I?d just slept on it wrong but that usually gets better as the day goes on and is gone the next day. This got worse as the day went on and I have both muscle pain that feels neurological, like a pinched nerve, and joint aches. It?s now Thursday the 18th and my arm still hurts although not as bad as it did Tuesday and yesterday. I don?t know if it?s unrelated but I see many reports of arm paid days later, so I thought it best to report.
52 2021-03-17 pain in extremity Patient reports receiving COVID-19 vaccination on 03/05/2021. Reports that the following morning, 03... Read more
Patient reports receiving COVID-19 vaccination on 03/05/2021. Reports that the following morning, 03/06/21, she had "severe arm pain rated 7/10 and she couldn't lift her arm as high as normal". Reports using ibuprofen and ice as needed over the weekend "made it a bit better, but was still there". Reports it did not interfere with her ADLs. Reports she "cannot lift her arm high without pain in her shoulder and top of the arm". Denies redness, swelling, bruising, or rash at injection site, but describes injection site as "high up" on her arm. At time of interview on 3/10/21, patient states her pain is 2/10 and has not used ibuprofen for the day. Reports she did not seek medical care.
52 2021-03-17 tingling tingle in the right arm that the vaccine was given.
52 2021-03-17 tremor, numbness 3/13 12 pm I got the shot. 30 mins after the shot, I got strong numbness for the whole body(especia... Read more
3/13 12 pm I got the shot. 30 mins after the shot, I got strong numbness for the whole body(especially face and arms), palpitations, dizziness, shaking chill at a time. I called 911 and went to ER. I got an IV. My symptoms were getting minor and I went home. The doctor said my symptoms are from a bad reaction to the medicine," Adverse Drug Reaction". I still have numbness on my face(left side cheek) a little bit.
52 2021-03-18 discomfort feeling off; light body ache discomfort; light body ache discomfort; left arm swollen-pain; left arm... Read more
feeling off; light body ache discomfort; light body ache discomfort; left arm swollen-pain; left arm swollen-pain; headache; fatigue; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261), via an unknown route of administration on 03Feb2021, 13:15, Left arm at single dose for covid-19 immunisation at Hospital. The patient was not pregnant. Medical history included Diabetic type 2, HBP (high blood pressure), Depression. Not aware of known allergies. Concomitant medications received in two weeks included losartan 50mg, escitalopram 10mg. The patient didn't received any other vaccine in four weeks. Historical vaccine included first dose (at the age 52 years) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on Left arm on 13Jan2021 19:00 at single dose for covid-19 immunisation. The patient experienced fatigue, headache, feeling off, left arm swollen-pain, light body ache, discomfort on 03Feb2021 at 19:00. No covid prior vaccination. Covid wasn't tested post vaccination. No treatment was received for events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
52 2021-03-18 feeling hot Feel an armpit swollen lymph lump; Body warmer than usual; Injection site pain; This is a spontaneou... Read more
Feel an armpit swollen lymph lump; Body warmer than usual; Injection site pain; This is a spontaneous report from a non-contactable consumer reporting for herself. This is the second of two reports. A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot En6201, via an unspecified route of administration in left arm on 23Feb2021 13:40 (at the age of 52 years) at single dose for covid-19 immunisation. The patient previously received the first dose of bnt162b2, Lot En9264, via an unspecified route of administration in left arm on 02Feb2021 13:30 (at the age of 52 years) at single dose for covid-19 immunisation and experienced injection site pain for 1 day. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Allergies to medications, food, or other products were none. Concomitant medication included losartan, vitamin d3, ubidecarenone (Q10). The patient experienced injection site pain on 23Feb2021, body warmer than usual on 24Feb2021, feel an armpit swollen lymph lump on 25Feb2021. Laboratory data included body temperature 37.3C on 24Feb2021, and normal on 25Feb2021. No treatment was received for the events. The events were non serious with outcome unknown. No follow-up attempts are possible. No further information is expected.
52 2021-03-18 feeling jittery Headache Fatigue, jittery
52 2021-03-18 migraine, flushing, pain in extremity Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue... Read more
Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue, increased heart rate, wheezing, joint pain, severe nausea, diaherra, possible seizure, confusion.
52 2021-03-18 pain in extremity sore arm; sleepy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant... Read more
sore arm; sleepy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 52-Year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, administered in right arm, on an unspecified date in Feb2021 at 5:00pm (at the age of 52 years old) as a single dose, for COVID-19 immunization. Medical history included diabetes. The patient did not have any known allergies. The patient did not experience COVID-19 prior to vaccination nor was tested for COVID-19 post vaccination. The patient did not take any concomitant medications in the past two weeks. The patient did not receive any other vaccines within four weeks prior to vaccination. The patient experienced sore arm and sleepy on an unspecified date. The patient did not receive treatment for the events. The clinical outcome of the events sore arm and sleepy were recovered on an unspecified date. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.
52 2021-03-18 tingling Patient received vaccine 03/18/21 at approximately 1200. At 1205 the patient reported a tightness in... Read more
Patient received vaccine 03/18/21 at approximately 1200. At 1205 the patient reported a tightness in her throat and a tingling in her arm. At 1209 Epinephrine 0.5 mg (0.5 mL) was administered IM. EMS called. At 1213 O2 saturation was 98 At 1215 BP was 169/87 HR was 73 At 1218 O2 saturation was 97 BP 167/83 HR 68 At 1220 O2 saturation was 98 BP 169/83 HR 76 At 1221 EMS arrived and took patient to the ED via ambulance. Update (03/19/21) Called patient to follow up and she stated she was evaluated at Medical Center ED and monitored for approximately an hour before being discharged home on 03/18/21. She stated she has had no further s/sx.
52 2021-03-18 tenderness Chills and Body Aches began the following morning after the injection and by 2:00 pm in the afternoo... Read more
Chills and Body Aches began the following morning after the injection and by 2:00 pm in the afternoon a large (ping pong ball sized) lump developed in the left axillary area that is very painful. The pain is constant when area is touched or with any arm movement. It feels like a knife is stuck inside my left axilla. I am guessing it may be a lymph node that swelled, but have not had it checked by a doctor. My last mammogram on November 16th, 2020 was clear and no indication of any lumps or swollen lymph nodes. This new lump appeared the following day after my Covid 19 vaccine.
52 2021-03-19 pain in extremity Both feet ache; can't stand, walk, or run without my feet aching afterward; they even ache when I am... Read more
Both feet ache; can't stand, walk, or run without my feet aching afterward; they even ache when I am not on my feet; I usually walk or run many miles every day. Perhaps this is unrelated to the vaccine but have never felt this before. The first day the symptoms developed by feet felt bruised on the bottoms. 10 days later and my feet still ache if I do any activity on them.
52 2021-03-19 tingling 3/20/2021 The patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccinati... Read more
3/20/2021 The patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: difficulty breathing and tingling around face and mouth Assessment : Time of assessment . Actions taken: VS taken, BP- 129/62, P- 80, O2- 100% at 521 pm , recheck at 0531pm, BP- 109/61, P- 77, O2- 100%, 545pm, BP - 105/69, P- 72, O2- 100%. Medications administered: Famotidine (Pepcid) 10 mg by mouth. Time: np. Administered by NP.Benadryl 25mg 1 tab PO x1 by NP, and given water. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/20/2021 5:09 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER2613 NDC: 59267-1000-1
52 2021-03-20 feeling hot Sweating and feeling warm occurred progressively
52 2021-03-21 inability to speak, numbness Left side facial numbness and speech difficulty
52 2021-03-21 discomfort, tingling Immediately after vaccine I became nauseous and dizzy with a headache. I went home and slept for the... Read more
Immediately after vaccine I became nauseous and dizzy with a headache. I went home and slept for the next three days. My body ached but the dizziness subsided. Today 03/22 I still feel nauseous and mildly aches. However my left elbow has now swollen up. It hurts to bed it and pressure hurts. I have pins and needles going through my wrist into my fingers along with a full ache.
52 2021-03-21 flushing c/o chest tightness, throat swelling and flushing
52 2021-03-21 pain in extremity Approx one moth post vaccine developed left arm pain radiating to neck and back, and decreased mobil... Read more
Approx one moth post vaccine developed left arm pain radiating to neck and back, and decreased mobility in arm.
52 2021-03-21 pain in extremity Sore arm 5pm day of until Monday Fatigue Headache Saturday night Diarrhea on Monday
52 2021-03-21 pain in extremity This was my second dose btw. Arm pain after first dose. No other noticeable symptoms. Second dose: H... Read more
This was my second dose btw. Arm pain after first dose. No other noticeable symptoms. Second dose: Headache almost immediately after being given the vaccine. Followed by arm pain/ache in BOTH arms, fatigue, lung pain, hip pain, general feeling of being unwell or having the flu. Went to work the next day. Still not feeling well. Felt even worse as the day progressed (with symptoms listed), went home early. Slept for twelve hours. Same symptoms the next day. Oddly, my symptoms seemed to relax a little after I ate lunch. Then returned a few hours later. Tomorrow will be 7 days after dose. I still have arm pain in both arms and extreme fatigue.
52 2021-03-21 tenderness warm and itchy toes, look like chillblains, swollen, tender, red, and looking like burst blood vesse... Read more
warm and itchy toes, look like chillblains, swollen, tender, red, and looking like burst blood vessels on 2 toes on one foot, and one toe on the other foot, started on 16 or 17th, March, still visible on March 22 - used some home made remedies and some triamcinolone, acetonide cream 0.1 % for the inflammation
52 2021-03-22 numbness the tech gave me a shot the pain was so intense and gave bad pain down my arm and have numbness in ... Read more
the tech gave me a shot the pain was so intense and gave bad pain down my arm and have numbness in my fingers. EMS at the site advised me to watch for potential hematoma and to go home and take tynelol and call primary physcian, Few hours passed pain persisted went to see a doctor she examined my arm and stated it is very possible that the she hit a nerve in my arm. She advised me to report this and to go back to the facility to report to supervisor. I went back to facility they advised to report on line and eventually it will feel better.
52 2021-03-22 tremor shortness of breath, difficulty swallowing, headache, chest pain, anxiety, and tremor
52 2021-03-23 pain in extremity her arm was swollen/ hand was also swollen; the joint in her shoulder felt like it was going to spli... Read more
her arm was swollen/ hand was also swollen; the joint in her shoulder felt like it was going to split off. It was extremely painful; her arm was swollen/ It was extremely painful; had been awake two nights unable to sleep due to pain; The pain was also creeping up her neck; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (pregnant: no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En7200), via an unspecified route of administration in left arm on 16Feb2021 at 14:00 at single dose for covid-19 immunisation. The relevant medical history included latex allergy and bee allergy, all from an unspecified date. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), modafinil and unspecified thyroid medication. The patient stated that her arm was swollen and the joint in her shoulder felt like it was going to split off. It was extremely painful. Her hand was also swollen and she had to remove her rings. She had been awake two nights unable to sleep due to pain. The pain was also creeping up her neck. The events started on 18Feb2021 at 22:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment included steroids and pain killers sling for arm. No covid prior vaccination and no covid tested post vaccination. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
52 2021-03-23 pain in extremity Had vaccination shot #2 in right deltoid. Went to the observation area for the 15 minute period. Aft... Read more
Had vaccination shot #2 in right deltoid. Went to the observation area for the 15 minute period. After approximately 7 minutes, I felt my throat "swelling." I got up and went to the RN who administered shot. They called the RN over. Vital signs were stable, airway intact, able to speak full sentences. No shortness of breath. It took more effort to swallow. Right arm sore. They monitored me for another 15 minutes. No worsening symptoms. Swelling not improving. Recommended going to the ER (I'm an RN and this was administered at my hospital). Was escorted to ER. Hooked up to monitor. Slight redness noticed on both arms. No hives. IV started. Given IV Benadryl, famotidine, solu-medrol. No improvement. Hooked up to a monitor and given epi sub-Q. Monitored for approximately 60 minutes with improvement of throat swelling. Discharged to home with prescription for prednisone, famotidine and Benadryl x 5 days. At home, approximately 8 hours after shot, work up feeling itchy, took Benadryl PO with relief of symptoms approximately 45 minutes later. Followed up with MD on 1/21. No change in medications. Asymptomatic during the course of medications. Finished course of medications on the morning of 1/23. Later that evening started feeling tired, had chills, swollen glands. Went to bed early. On 1/24 symptoms continued including lack of appetite, increased fatigue, brain fog. Symptoms continued until 1/25 and gradually improved over the week.
52 2021-03-23 pain in extremity Chills, aching for 24 hours Sore arm for 24 hours then less intense for about a week
52 2021-03-23 tremor Patient started feeling "lightheaded" and then felt as if hands were shaking. NO visible shaking not... Read more
Patient started feeling "lightheaded" and then felt as if hands were shaking. NO visible shaking noted. Feeling dissapeared within about two minutes.
52 2021-03-24 slurring, pain in extremity, tingling Pain and tingling in my left are and shoulders, slur speech, stroke like symptoms
52 2021-03-24 feeling cold I felt my throat closing up, making it more and more difficult to swallow or breathe; my throat felt... Read more
I felt my throat closing up, making it more and more difficult to swallow or breathe; my throat felt like a mild cold; more difficult to swallow; difficult to swallow or breathe; hives on my neck; swollen face and neck; swollen face and neck; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 12:00 (Batch/Lot Number: EN 620H) as single dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient previously took polio vaccine for immunization and experienced allergy, nickel and experienced allergy, chloroxylenol and experienced allergy, cetirizine hydrochloride (ZYRTEC) and experienced allergy, clarithromycin (CLARITIN) and experienced swelling face. The patient stated that, "After the vaccine was administered (18Mar2021 12:00) my throat felt like a mild cold making it a little more difficult to swallow. As I was sent to the high risk area I was monitored by a nurse. Upon leaving I got into my car that was warm inside. As I was driving I felt my throat closing up, making it more and more difficult to swallow or breathe. I went to a (store) and spoke to the pharmacist there. She advised me to take Benadryl immediately. She noticed hives on my neck and a swollen face and neck. As Benadryl took effect the hives receaded and the swelling of my face and neck went down. I went back to the vaccination site and seemed medical attention from the (Department name) Department team. They checked my vital signs and released me after a waiting period without any further medication being administered. I was given an appointment for 08Apr2021. I am concerned about an adverse reaction at the second appointment. Is it better to wait a little longer for the second dose to be given?" Patient is not pregnant. Therapeutic measures were taken as a result of the events included Benadryl. Outcome of the events was resolving.
52 2021-03-24 flushing Flushing face, heavy tongue, light rash left arm, stomach irritation (nausea).Patient developed a re... Read more
Flushing face, heavy tongue, light rash left arm, stomach irritation (nausea).Patient developed a reaction to COVID-19 vaccine 5 min. after injection administration flushing face, heavy tongue and light rash and nausea were the symptoms showed up by patient. V/S BP 198/886, P-63, Sat. 99%. Patient transferred to Hospital to get medical care and be under observation.
52 2021-03-24 hot flush Fever and moderate headache off and on for first 24 hours. Hot flashes starting day 2 around 1pm... Read more
Fever and moderate headache off and on for first 24 hours. Hot flashes starting day 2 around 1pm off and on. Rapid heart rate with chest pressure and sweating (measured 129) at about 5pm day 3. Lasted 25 minutes. Severe irritability at about 8am day 3 and ongoing
52 2021-03-24 night sweats Stomach cramps, fever, headache, night sweats
52 2021-03-24 pain in extremity Sore arm the night of the vaccination, Hives developed 2 days after vaccinated. Hives spread all ove... Read more
Sore arm the night of the vaccination, Hives developed 2 days after vaccinated. Hives spread all over body. Very itchy. Hives stays more than 1 week after the vaccine.
52 2021-03-24 pain in extremity I woke up about 12 hours after with a headache and chills. The day after, I only had some arm pain. ... Read more
I woke up about 12 hours after with a headache and chills. The day after, I only had some arm pain. A few days later, I had the diverticulitis flare up. I was place on antibiotics and that resolved the issue. I had Dose 2 (EL3246)on 1/26/21 and it was a similar situation, except that it was about 2 weeks later when the flare up occurred. I don't know if it was another reaction or it just wasn't resolved the first time.
52 2021-03-24 pain in extremity After 15 minutes of observation, patient complained of left arm pain and chest pain. Patient was tak... Read more
After 15 minutes of observation, patient complained of left arm pain and chest pain. Patient was taken into an exam room, EKG performed and reviewed by Dr. EKG was normal however given patients previous history and symtoms, 911 was called and patient was transported to the Hospital. Patient was later discharged based on "suspected anxiety and perhaps minor reaction to vaccination are at play here."
52 2021-03-25 burning sensation Beginning at 9pm on 3/15/21, I had sharp pains in my chest and an elevated heart rate. Every day sin... Read more
Beginning at 9pm on 3/15/21, I had sharp pains in my chest and an elevated heart rate. Every day since, I have had chest pain/pressure, sharp pains in my head accompanied by a burning sensation throughout the top and back of my head and a burning sensation throughout my upper back and arms.
52 2021-03-25 cold sweat Complaints of headache, cool to touch, "body feels weird". Bp 140/90, HR 78, pulseox 100%. Rechec... Read more
Complaints of headache, cool to touch, "body feels weird". Bp 140/90, HR 78, pulseox 100%. Recheck at 5:35 BP 128/84 , HR 77 99%puse ox.
52 2021-03-25 feeling hot, numbness, hot flush, electric shock sensation Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face l... Read more
Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face lips and tongue 60 minutes after 1st dose. Premedicated with Pepcid 20 mg and Benadryl 50mg 1 hour prior to 2nd vaccination with no adverse reactions occurring. Presented with popping, in ears, eye blurriness, numbness on face and head, swollen glands on bilateral neck, burning in chest happening in waves 2 -3weeks after 2 nd dose. Normal CPK, CBC and CMP results. 2/4/2021 episodes of heat throughout body, questionable palpitations, headaches, blurry vision, numbness on head and face, feeling faint and unbalanced during episodes. - comes in waves. Electric shocked under skin all over body and once in Bihar eyes. Normal brain MRI and follow up bloodwork. Visits to neurologist, GYN and ophthalmologist.
52 2021-03-25 flushing Patient received first Covid-19 vaccine at 2:47. Patient reports within a minute or two she began to... Read more
Patient received first Covid-19 vaccine at 2:47. Patient reports within a minute or two she began to feel flushed and faint. Patient did not have syncopal episode. Patient was taken to separate room where she could lay down. Patient given crackers and water. Vitals taken at 3:18 - BP 150/100, HR 82, SpO2 100%. Patient seen by Doctor. Vitals repeated at 3:30 - BP 155/95, HR 87, SpO2 100%, Temp 97.9F. Doctor reported patient feeling fatigued, but lightheadedness, flushing, and dizziness had resolved. Doctor advised patient contact someone to take her home. Also advised to follow up with her PCP for elevated BP. If symptoms worsen or new symptoms arise, patient advised to go to ED for evaluation. Patient verbalized understanding. BP checked once prior to patient leaving at 4:32 and was 142/100. Patient's sons came to clinic to drive her home.
52 2021-03-25 muscle spasms Severe muscle pain at injection site at 630pm. By 10pm my body started to ache from neck, shoulders,... Read more
Severe muscle pain at injection site at 630pm. By 10pm my body started to ache from neck, shoulders, body down to legs. Severe chills with shivering for almost 2 hours. Low grade fever 99. Could not walk or stand. Took tylenol at 11pm with little effect, then again at 330am due to chills, muscle aches n spasms in legs, slight headache, very tired and miserable feeling. Slept and woke up at 8am sweating under blankets and feeling less sore muscles. Hydrated with water, and by 9am just feeling tired. Soreness of injection site gone as well as body aches. Just fatigue feeling. Will still go to work on 3-26-2021 after thinking there was no way I can move my body. Not feeling 100% at 943am but much better than earlier flu type feeling.
52 2021-03-25 pain in extremity When leaving walking in parking lot very dizzy felt like I was drunk ( I do not drink at all) same w... Read more
When leaving walking in parking lot very dizzy felt like I was drunk ( I do not drink at all) same when I got home. Slept 2 days, woke up little wheezing, BAD headache....lasted 3days . Next day I had bad muscle pain, some bone pain, arm sore that wasn?t bothersome. EXTREME FATIGUE .....couldn?t get off couch bout 8 days. When I did very dizzy would stagger to the right. Fell into other couch trying to get up bout the 3 day. Fatigue was getting worse, hard to move body, VERY SLEEPY . Family insisted I go to ER or they would call EMS. I only will go if on death bed. This was 1st time in life I waited 8 days to shower, I?m a very clean person, I will even do my makeup almost daily. My biggest concern is the MALAISE AND FATIGUE WAS WORSENING AS DAYS WENT ON. I DO HAve Hx. Of reactions to tetanus but nothing like this. I?m waiting to go to dr to have labs drawn because of this. Thanks you
52 2021-03-25 throat numbness Client received vaccine approx 3:15pm. Reported throat and chest tightness and throat numbness at 3:... Read more
Client received vaccine approx 3:15pm. Reported throat and chest tightness and throat numbness at 3:25. V/S: HR 78, BP 133/76, RR 12. At 3:40pm, client reported diminishing symptoms and no new symptoms reported. At 3:50pm, client left site unassisted and with a steady gait, accompanied by husband. No medication provided
52 2021-03-25 unresponsive to stimuli Patient rec'd Pfizer Vaccine at site on 3/23/21 and was found unresponsive at home 4 hours later. Cu... Read more
Patient rec'd Pfizer Vaccine at site on 3/23/21 and was found unresponsive at home 4 hours later. Currently Hospitalized
52 2021-03-26 numbness Severe numbness in the left side of face , tongue, mouth ,ear neck, arm and foot.
52 2021-03-26 numbness Patient reports numbness on left arm (injection arm), positive PMS. Visual inspection reveals no sig... Read more
Patient reports numbness on left arm (injection arm), positive PMS. Visual inspection reveals no significant abnormalities.
52 2021-03-26 migraine, pain in extremity Day 1 felt like my arm was in extreme pain, resolved a little over 24 hours. Day 2 I woke feeling li... Read more
Day 1 felt like my arm was in extreme pain, resolved a little over 24 hours. Day 2 I woke feeling like someone attacked the left back of my head with a hammer. It's now day 4 and my head still feels like a watermelon, about to explode. Tried migraine meds no help, heat send to be the only partial relief available.
52 2021-03-26 tremor Chills, unable to stop shaking, extreme headache, fatigue, mild nausea
52 2021-03-27 discomfort Pain and discomfort in right arm pit with a noticeable large swollen lymph nodes. Currently still s... Read more
Pain and discomfort in right arm pit with a noticeable large swollen lymph nodes. Currently still slightly swollen but not painful as of today 03/28/21. Second dose is scheduled for 04/10/21.
52 2021-03-27 pain in extremity I immediately started having a pain run from the vaccine location in my arm to my neck. I have conti... Read more
I immediately started having a pain run from the vaccine location in my arm to my neck. I have continued to have a severe (catch) or some call (Crick) in my neck since the vaccine . The arm pain subsided in about 24 hours, but on day three since the vaccine, I cannot turn my head for the catch in my neck.
52 2021-03-27 pain in extremity Soreness in arm Diarrhea Dizziness
52 2021-03-28 bell's palsy Started with nausea at 1:30AM on 3/20/2021 and feeling unwell. At 10:00AM ON 3/21/2021 started havin... Read more
Started with nausea at 1:30AM on 3/20/2021 and feeling unwell. At 10:00AM ON 3/21/2021 started having pain in/behind left ear. This continued up to the time when on 3/24/2021 at 6:45AM my left eye was blinking slower than the right eye and the left-side of my mouth showed signs of drooping. I was admitted to the ER for possible stroke due to symptoms I was having but test results showed Bell?s Palsy. Treatment is acyclovir, ketorolac, prednisone and artificial tears ointment
52 2021-03-28 numbness, flushing lightheaded/dizzy, left side facial numbness, flushing. Evaluated by EMS-Cleared
52 2021-03-28 numbness Patient vaccinated 3/25/2021, states next day in the afternoon developed numbness to right face, arm... Read more
Patient vaccinated 3/25/2021, states next day in the afternoon developed numbness to right face, arm, leg, and body. No weakness.
52 2021-03-28 pain in extremity, tremor Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath ... Read more
Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath very quickly within 15 minutes. Normally do 30 minutes and can speak through it. Just thought I was tired. Overnight joint pain significant in knees, fingers and shoulder blades. Husband told me I was moaning throughout the night and turning from side to side. Got up to go to the bathroom once and head felt foggy. Morning got up as usual and quickly became light headed. Started to black out to the point where sitting down and putting my head down didn?t help. Was blacked out and yelled for my husband. Husband carried me to the couch what I was saying he thought I was hallucinating. Began to have whole body trembling - not necessarily chills just trembling. After about an hour subsided. Blacking out lasted on and off throughout the day. O2 stats between 91 and 94 throughout the day, fast heart rate 90+. No fever. Stayed in bed all day, barely moved. Restless and couldn?t get comfortable - very bad headache. Going in and out of sleep. Treated with Tylenol arthritis and ibuprofen. Drank water and some hot tea. Very hard to even drink anything. Next day felt like I had been sick although by 5pm seemed to be back to baseline.
52 2021-03-28 tingling, difficulty speaking Woke up in the middle of the night with tingling pins and needles feeling on my tongue. My voice was... Read more
Woke up in the middle of the night with tingling pins and needles feeling on my tongue. My voice was very hoarse and had some nasal congestion. I could breathe but my throat felt a little swollen. I had a similar but much worse reaction to a flu vaccine 10 yrs ago but during that incident my face/lips swelled in addition, so I went to the ER.
52 2021-03-28 tingling, facial pain, numbness, nerve pain, pain in extremity By the evening of the first day: Severe headache, face pain, neck pain( both muscle and nerve), neck... Read more
By the evening of the first day: Severe headache, face pain, neck pain( both muscle and nerve), neck tension, left and right arm pain and tingling, pain and tingling in left leg( mild). Talking hurt my face, smiling hurt my face. Being in any position where my arms hung down at my sides hurt everything above my mid back. Took 200 mg of Gabapentin. This allowed me to sleep. At noon on Mar 21, starting taking Ibuprofen, 800 mg 3x daily. After most of a week of doing little other than sitting and reading, the pain seemed to subside somewhat. Sat Mar 27th evening : increase of upper body pain after small amount of light work with arms followed by nausea and vomiting. Visited Emergency room. Blood tests were taken. The tests were normal. Vomiting subsided after doses mof anti-nausea medication for 24 hours. Nausea has not returned. Started taking 500 mg of Methocarbamol nightly. Started taking Tylenol 3 x daily on Mar 28 Presently: The pain in my left leg has gone except for the foot pain that I have lived with for 2 years. The left leg tingles mildly once in a while. All other pain is nearly the same. I am unable to do much more than type or sit and read. If I look down to do a task, after a few minutes, I get a sharp nerve pain in my face, head, and neck. The skin on the back of my neck has been mildly numb for several days.
52 2021-03-28 tenderness medium size red circle on arm-- with lump. Lump grape size/circle bigger than a plum. Tender to to... Read more
medium size red circle on arm-- with lump. Lump grape size/circle bigger than a plum. Tender to touch. No itchiness
52 2021-03-29 difficulty speaking 5 min after dose my heart was racing and it hurt/ felt tight . 10-20 minutes after dose my tongue w... Read more
5 min after dose my heart was racing and it hurt/ felt tight . 10-20 minutes after dose my tongue was tingling /burning feeling also felt swollen. My throat felt tight and it was difficult to swallow. But I could breath okay. I stayed at the location for approximately 45 min -1hr for monitoring. After leaving I had a couple episodes where my chest got tight and I couldn?t catch my breath but after 4 hrs it cleared up. My throat hurt for 3-5 days afterward and I had a hoarse voice. My tongue still hurts, it felt tingly and burnt shortly after 1st dose and turned paper white for 2-1/2 weeks, now (3wks after the dose) it feels like someone ran a razor blade over it and is turning back to its normal pink color. It is starting to feel a little better. Last week (2 weeks after dose #1) I reacted to wall paint, my hands broke out in hives and got itchy, which I?ve never reacted to in the past. They cleared up after washing them and waiting 2-3 hrs. I also have a slight reaction to pasta sauce now, my lips get slightly puffy and hurt while eating it.
52 2021-03-29 flushing Seven minutes after injection, I had itchiness on the roof of my mouth. Then, I also had itchiness o... Read more
Seven minutes after injection, I had itchiness on the roof of my mouth. Then, I also had itchiness on the tip of my tongue. After 45 minutes to 1 hour, I also had itchiness in the back of my throat. From time to time, my heart raced momentarily but then was normal. I never had trouble breathing. Around the one hour mark after vaccination, I took two Zyrtec. Within the next hour, my symptoms went away. Differences between the second dose and my first dose: my face and neck were flushed soon after the first vaccination but not the second. After the first vaccination, my lips were also tingly and itchy but not after the second vaccination. I took two Zyrtec 30 minutes after the first vaccination but tried to wait longer after the second to see if symptoms would resolve on their own. When they progressed to itchiness in the back of my throat, I took the Zyrtec.
52 2021-03-29 pain in extremity I had COVID in March 2020 and tested positive for antibodies in December 2020. Symptoms following v... Read more
I had COVID in March 2020 and tested positive for antibodies in December 2020. Symptoms following vaccination were similar to when sick with COVID and began approximately 18 hours after receiving injection. Fever of 102 degrees Fahrenheit, body aches, headache and extreme fatigue on first day after vaccination. On second day, fever was 100 degrees, body aches, headache and fatigue. Fever was gone by third day, but still had some fatigue in morning. Completely recovered by day four. Also experienced extreme soreness in arm. Soreness was intense beginning approximately 18 hours after vaccine. On second day after vaccine, also developed an itchy rash at area of vaccination. Soreness and rash began to disappear on day three and was gone by day four.
52 2021-03-29 pain in extremity Chills, Temp. 36.4, Headache, Sore Arm and muscles, Arthritic joints, Low Back Pain, Ringing in ears
52 2021-03-30 burning sensation, tingling After 1hour / 1 1/2hour from injection start tingling left side of tongue, lip, swelling the throat ... Read more
After 1hour / 1 1/2hour from injection start tingling left side of tongue, lip, swelling the throat After 2hours find a red burning rash under breast/torax.Called health clinic, the Triage nurse directed me to hospital.Went to the Emergency room. Main Hospital Team Dr. Diagnose:allergic reatcion+Yeast infection. 7:28PM gave 3 pills prednisone. Pescription for Prednisone 20mg 3for4days, nyastatin podwder for rush, epinephrine injection in case of anaphylaxis, benadryl as needed.While I was at ER, the tingling/swelling expand my entire body left side. This night I had to remove wedding ring, today the face still swelling/warming+almost same/little bit worsening simptoms
52 2021-03-30 cold sweat my body was aching with cold sweat; my body was aching with cold sweat; fever; headaches; This is a ... Read more
my body was aching with cold sweat; my body was aching with cold sweat; fever; headaches; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unspecified route of administration on 12Feb2021 08:00 on Left arm at single dose for covid-19 immunisation. The patient medical history included Asthma, Eczema, Peppermint allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), on 22Jan2021 15:45 on Left arm at single dose for covid-19 immunisation and experienced headache and Dizziness. Concomitant medications in two weeks include Montelukast (Strength: 10mg), Loratadine (Strength: 10mg) and cyclobenzaprine. On 12Feb2021 09:00, the patient reported, on his first shot he had headache and he was light head for 2 days. One the 2nd shot he was having headaches, my body was aching with cold sweat and he was having fever and temperature was 101. He states, he never had the covid at all. He started feeling better after 4th day. He started drinking emergency C one pack 1000 mg and had 3 packages in a 23oz water bottle. No other vaccine in administered in four weeks of vaccination. No treatment was given. No covid prior vaccination. Covid was not tested post vaccination. The outcome of events was resolving. Information on the lot/batch number has been requested.
52 2021-03-30 difficulty speaking, weakness Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing... Read more
Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing; Extreme weakness; exhaustion; abnormal mentation; cough; hoarseness; gum pain; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included type one diabetic and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, tramadol hydrochloride (TRA), levothyroxine and pramlintide acetate (SYMLIN). On 31Jan2021 18:00, The patient experienced severe pain throughout body, esp head, stomach, and tongue throbbing. extreme weakness, exhaustion, abnormal mentation, cough, hoarseness, gum pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
52 2021-03-30 pain in extremity, tremor high level of shortness of breath; Diarrhea; spinal column hurt the worst (the spine from the top of... Read more
high level of shortness of breath; Diarrhea; spinal column hurt the worst (the spine from the top of her neck to her butt); butt muscles hurt really bad; caller's spinal column hurt the worst, the front of her calves and hip joints; spinal column hurt the worst, the very edges of her back, the side of her back was excruciating; Dizziness; Vomiting; not feeling well enough; shaking; shivering/ chills; pulse ox and it dropped down to 93; Excruciating body pain; Headache; sore arm / front of her calves, front of her thighs, left arm, 3 left fingers; Exhaustion; no appetite at all; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 08Mar2021 at 10:15 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing epilepsy since Oct2015 (officially diagnosed in Oct2015, but the doctors believed it was in her early 20s but she was misdiagnosed for decades), post-traumatic stress disorder (PTSD) from 2020 (diagnosed a year ago), sleep apnea since 2016 (patient thought she was diagnosed in 2016), COVID-19 in Nov2020 from which the patient almost died, memory loss (left over COVID symptom) for which the patient was in speech therapy, intermittent body pain (aftereffects of COVID-19), relapse in seizures due to COVID-19, her eyesight was terrible, epilepsy migraines. Concomitant medications included unspecified epilepsy medications. There was no other vaccine given on the same day, or 4 weeks prior to the vaccination. The patient previously received a flu shot and fainted, on an unspecified date. On 08Mar2021 at 11:15, the patient experienced sore arm (pain 2/10). On 08Mar2021 at 22:00, the patient had headache which got progressively worse, then it got so bad she wanted to pop her head off at midnight. On 09Mar2021 at 00:00, the patient had shaking and shivering where it looked like she was convulsing (she had history of epilepsy and knew what a seizure felt like, her husband may have thought she was having a seizure). The patient had chills to the point where she had multiple blankets and could not stop shaking, took her pulse ox and it dropped down to 93. The caller's baseline temperature was 97.1 and her daughter took her temperature and it was 98.9, most people wouldn't consider that a temperature, but it was a temperature for her. The caller kept shaking like that for hours. On 09Mar2021 between 21:00-23:00, the patient had chills again. On 09Mar2021, the patient experienced excruciating body pain (pain 9/10) in very specific parts of her body. On 09Mar2021 by 12:00, the caller's spinal column hurt the worst, the front of her calves and hip joints, the very edges of her back, the spine from the top of her neck to her butt and then next to it was not so bad but the side of her back was excruciating, the butt muscles hurt really bad, the front of her thighs, left arm, 3 left fingers, but not the other 2 fingers. Oddly enough, she was considered a long hauler, it was the places that her occupational therapist and physical therapists were working on. On 09Mar2021 at 00:00, the patient experienced dizziness (that was on and off all day until bedtime last night on 09Mar2021) and vomiting (she couldn't hold down water). On 09Mar2021, the patient was not feeling well enough. On 10Mar2021 at 08:00, the patient experienced diarrhea (she's only gone to the bathroom twice). On Mar2021, the patient experienced exhaustion and no appetite at all. On an unspecified date, the patient experienced a high level of shortness of breath (patient was unsure if this was due to COVID-19). The patient underwent laboratory tests and procedures which included an echocardiogram on an unspecified date: her left atrium was enlarged and her cardiac numbers were high, they were going to monitor her heart and the doctors didn't know if it was because she had COVID-19 or if it was that the doctors got lucky and found it, they had nothing to compare it to because she only had this one echocardiogram. The patient had history of epilepsy migraines (can pinpoint the spot where it hurts), she thought she would try sumatriptan succinate (IMITREX) for this headache (her whole head hurt), as it didn't interact with her other medications. The patient also took acetaminophen/diphenhydramine (TYLENOL PM; Lot: GF6062, Expiry: Jun2022), ibuprofen (patient thinks the Lot is QWE2546A, but is unsure) for the headache. The patient took ondansetron (ZOFRAN) which she had from a previous prescription and that made the vomiting stop. The events did not require an emergency room or physician office visit. The patient did not think that the reactions were due to her epilepsy medication. The clinical outcome of excruciating body pain was resolved on 09Mar2021 (it's hard for the caller to say if she has recovered because she had COVID-19 aftereffects and had body pains that come back intermittently), sore arm / front of her calves, front of her thighs, left arm, 3 left fingers, shaking, shivering/chills, pulse ox and it dropped down to 93, spinal column hurt the worst (the spine from the top of her neck to her butt), butt muscles hurt really bad, caller's spinal column hurt the worst, the front of her calves and hip joints, spinal column hurt the worst, the very edges of her back, the side of her back was excruciating, dizziness, vomiting, not feeling well enough, no appetite at all was resolved on 09Mar2021; headache was not resolved (unless the caller was asleep, she felt the headache); exhaustion was not resolved; diarrhea and high level of shortness of breath was unknown. Information on the lot/batch number has been requested.
52 2021-03-30 tingling Pt experience b/l hand tingling and then sob after getting vaccine, approx 10 min later. Improved a... Read more
Pt experience b/l hand tingling and then sob after getting vaccine, approx 10 min later. Improved after 25mg benadryl, called ems and taken to ER for ekg and observation.
52 2021-03-30 tingling Patient concerns of left hand "tingling and stiffness" following administration of COVID-19 vaccine.... Read more
Patient concerns of left hand "tingling and stiffness" following administration of COVID-19 vaccine. Patient refused EMS, stating she "feels comfortable driving home by herself". Speech, gait and mentation at baseline. Patient reports a history of multiple sclerosis, and that she sometimes gets "tingling" with her MS injections. Patient left under own volition.
52 2021-03-30 seizure, feeling cold feeling cold; running a fever 101.7; Headache; her muscles are seizing; she couldn't move her arms; ... Read more
feeling cold; running a fever 101.7; Headache; her muscles are seizing; she couldn't move her arms; muscles have gotten tired so she is a little sore; muscles have gotten tired so she is a little sore; seizures; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6199) via an unspecified route of administration in left upper arm on 16Mar2021 at 15:10 (at the age of 52-years-old) at a single dose for covid-19 immunization. Relevant medical history included typical soreness. She says her son has sensitivity to vaccines. But she only ever has like typical soreness and stuff but normally she goes through fine. She went through the first dose of the vaccine fine. Patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6200) administered on an unspecified date via an unspecified route. No prior vaccinations within 4 weeks were received. Patient reported that she had the second one yesterday and she is having some symptoms. It started with a headache, then running a fever of 101.7 on 17Mar2021. The things she is concerned about and she has been making all these calls about this morning is her muscles are seizing, like her whole body, down her back and derriere and her legs seize up and become like a board, it does not hurt but after a while she guesses her muscles have gotten tired so she is a little sore but it is not like a horse, her muscles just seize up, she couldn't move her arms on 17Mar2021. Its happened several times. She wanted to report it and make sure this is within the norm or if she should be going further with it. The headache started during the night, she says it was after midnight so 17Mar2021. It is ongoing but much less. Last night it was horrible, she confirms ongoing but improved. Her fever is ongoing at this time it is going up. Started out at 100.6 now it is 101.7, that also began 17Mar2021. It is getting worse. Her seizing muscles she noticed that at about 1 AM this morning so 17Mar2021 as well. It is ongoing but seems to be lessened. There is more time in between them. It was every hour but right now it is happening every 2-2.5 hours so it is improving. Patient stated that during the night/early this morning patient began experiencing feeling cold, seizures (undiagnosed. Muscle involvement), She explains seizures as not brain related, neck down to my leg, Tighten up. Hold for 10-15 seconds. Flatten out like a board, then it'll go away. Vaccination Facility Type was Hospital. No history of all previous immunization with the Pfizer vaccine. Additional Vaccines Administered on same date of the Pfizer Suspect was none. Adverse events do not require a visit to Emergency Room or Physician Office. The outcome of the events seizure, feeling cold, myalgia, muscle discomfort and limb discomfort were unknown, while for headache and muscle disorder was recovering and for fever was not recovered.
52 2021-03-31 feeling hot Burning in center of chest, red, hot cheeks, neck & chest, heart rate 122bpm, blood pressure 169/93,... Read more
Burning in center of chest, red, hot cheeks, neck & chest, heart rate 122bpm, blood pressure 169/93, felt like I was breaking into a sweat but skin dry
52 2021-03-31 flushing client complained of headache and lightheaded approximately 15 mins after receiving the 1st dose of... Read more
client complained of headache and lightheaded approximately 15 mins after receiving the 1st dose of Pizer Covid vaccine (lot#EW0150 Exp 4/3/21). EMT responded. First vitals at 1138: blood pressure 140/90, pulse 65, oxygen 100%, respiration 18. Client alert and oriented, no medical condition at this time, medications are just daily vitamins, B12, Vit D, magnesium and zinc. Allergy to sulfa medication. PHN joined EMT. Per client symptoms started at 1114 but did not inform staff until later. Client reported to PHN feeling flushed, PHN offered benadryl. Client declined, asked to contact husband first since she drove alone. At 1141 client asked to use restroom, EMT accompanied client to outside of restroom. Client was able to walk with steady gait, no complaints. 1145 client stated she would wait the remaining 30 min observation and report if headache worsened. Client decided to not take benadryl after speaking with husband. Lightheaded feeling and flushing had resolved. EMT stayed with client. Client advised to speak with provider prior to second dose. ER precautions given. Last set of vitals at 1150: blood pressure 130/ 80, oxygen 100%, pulse 70.
52 2021-03-31 numbness, cold extremities, tingling left hand was cold in the pinky and into half of her palm; left arm feels a little heavy; prickly fe... Read more
left hand was cold in the pinky and into half of her palm; left arm feels a little heavy; prickly feeling around her right eye; prickly feeling around her right eye and then she started feeling it in her left cheek on her face. She said that it then went to her left arm; prickly feeling in her lips. Then it went to right nostril and then to the roof of her mouth; numbing feeling in her palm and pinky in her left arm/ numbness in her left arm; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at the age of 52-years-old, administered in Arm Right on 04Mar2021 17:15 (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included, rotator tear, surgery, nerve block, muscle relaxant therapy, sciatica, neuropathy, numb in her leg in her thigh and from the knee down. She had a reaction to muscle relaxers that she was taking for sciatica and stated that it caused her to go numb in her leg in her thigh and from the knee down and it took 3 months for it to go away, but she still has neuropathy in that leg since then. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at the age of 52-years-old, administered in Arm Left on 11Feb2021 (Lot Number: EL9269) as single dose for COVID-19 immunization. Patient is a schoolteacher that was calling about the Covid-19 vaccine and reported that within 10 minutes (04Mar2021) she felt a prickly feeling around her right eye and then she started feeling it in her left cheek on her face. She said that it then went to her left arm and then she got a numbing feeling in her palm and pinky in her left arm. She had no difficulty breathing. The paramedic came and looked at her and asked her to drink the rest of her water. She waited another 30 minutes before leaving and she said that she was fine. She said that when she was leaving she felt the prickly feeling in her lips. Then it went to right nostril and then to the roof of her mouth. She still has the numbness in her left arm, palm, and pinky. She said that she took some Benadryl and it helped. At one point she did have difficulty swallowing and that is what is what prompted her to take the Benadryl. She said that she stopped and got coffee and she felt like her throat was getting hard and she had difficulty swallowing and it lasted about 2 minutes and she took Benadryl to treat it at the time. She said that the Covid-19 Vaccine gave her that same sensation as the muscle relaxer and she did not like that feeling. The numbness and prickly feeling is the same on her left arm. She said that it was on her right arm and hands, but it is not there or on her face anymore. She said that her left hand was cold in the pinky and into half of her palm (unspecified date). She said that her left arm feels a little heavy (unspecified date). She feels like it is heavy and she is trying to wake it up. That left side she had a rotator tear and she had surgery and had a nerve block. She said that it was a couple of years ago. She said that it felt like Deja Vu. Patient wanted to know if this is something that is involving her nerves? She is going to make an appointment with her physician. Therapeutic measures were taken as a result of "prickly feeling around her right eye", "prickly feeling around her right eye and then she started feeling it in her left cheek on her face. She said that it then went to her left arm", "prickly feeling in her lips. Then it went to right nostril and then to the roof of her mouth", "numbing feeling in her palm and pinky in her left arm/ numbness in her left arm", difficulty swallowing. The outcome of the event paraesthesia, hypoaesthesia was not recovered, of dysphagia was recovered on 04Mar2021, while for the other events was unknown. No Prior Vaccinations (within 4 weeks). No Family Medical History Relevant to adverse events. No Relevant Tests.
52 2021-03-31 muscle spasms, weakness Patient reports symptoms starting a few hours after vaccination, started with chest heaviness, then ... Read more
Patient reports symptoms starting a few hours after vaccination, started with chest heaviness, then severe joint pain, O2 sat 91-94% on Room air, Went to bed, the next AM same symptoms but also experienced increased weakness unable to stand feeling like she was blacking out, almost had a fall, layed down then had involuntary muscle spasms, very weak and then headache. This lasted through the day 3/26/2021. Better the following day 3/27 but still felt some weakness through 3/28.
52 2021-03-31 cold extremities Mar 29-6pm Left arm injection site began to hurt and painful to touch Neck muscles on right side of ... Read more
Mar 29-6pm Left arm injection site began to hurt and painful to touch Neck muscles on right side of neck and tongue began to swell Extreme fatigue took over body Mar 29-8pm Rash and itching in following regions: Around collar area/bra line/buttocks/back of thighs/lower back/behind knees/in elbow crease/back of arms Injection site swollen and painful Mar 30-2am Painful abdominal bloating and gas nausea frequent urination chills/arms and feet would not warm up muscle pain joint pain Mar 30 2:30-3:30am vomiting-multiple times and loose stool elimination/turning to diarrhea continued chills and inability to warm up hands and feet complete fatigue Continued muscle pain/joint pain and injection site pain/swelling Mar 30 2:30pm Low grade fever (99.8) all other symptoms remain and limbs begin to warm up Slept from Mar 30th @ 7pm-Mar 31st-7am Mar 31 Woke at 7am and felt much better Injection site on arm still tender, but improving Fever gone/temperature normal (97.5) rash dissipated Joint and muscle pain lingering (reported side effects to Pfizer reporting mid day of Mar 30
52 2021-04-01 facial paralysis, numbness left side facial numbness with facial droop
52 2021-04-01 flushing ears ringing, flushed, itching. Evaluated by EMS-Cleared
52 2021-04-01 pain in extremity Bad headache and fatigue began within 2 hours of injection and lasted for about 36 hours; low fever ... Read more
Bad headache and fatigue began within 2 hours of injection and lasted for about 36 hours; low fever began approx 5-6 hours after injection and lasted about 6-8 hours; arm pain to the point of difficulty lifting or moving arm began approx 9 hours after injection (injection site never hurt) and lasted approx 10 hours
52 2021-04-02 feeling hot Pt reported feeling warm and her heart racing. She also complained of a headache. Patient was given... Read more
Pt reported feeling warm and her heart racing. She also complained of a headache. Patient was given water and after 40 minutes was feeling fine, no longer feeling flushed or warm.
52 2021-04-02 flushing Two events of headache and fatigue and slight face flushing. First day of 2nd shot and day after 2n... Read more
Two events of headache and fatigue and slight face flushing. First day of 2nd shot and day after 2nd shot. March 26 and March 27. Second event 6 and 7 days after 2nd shot. April 1 and April 2. Felt fine in between.
52 2021-04-02 flushing Time of vaccine: face flushing, warm face and throat Day 2 post vaccine; worst headache since I had... Read more
Time of vaccine: face flushing, warm face and throat Day 2 post vaccine; worst headache since I had a spinal fluid leak. Immobilized in dark room, no sound. Wrapped head in ice packs for 24 hours. Nausea. 5 through 10 days post vaccine: severe dizziness, nausea, full body muscle aches, extreme fatigue. Walking from room to room exhausts me. Dizziness all the time.
52 2021-04-02 flushing Several days after my first dose a broke out in hives/rash all over my arms legs and body. I have in... Read more
Several days after my first dose a broke out in hives/rash all over my arms legs and body. I have intense uncontrollable itching and skin is burning and painful. I feel hot (flushed), achy and unwell. This has disrupted my daily activities and interfered with sleep I went to my regular doctor first and was started on prednisone. I went back 2 days later because I didn?t see an improvement. They gave a medrol dose pack of steroids. Later that night it continued to get worse so I went into the ER. Was treated there with solumedrol, and benedryl by IV. Left that night but returned again to the ER the next day because of unbearable pain in stomach and violent throwing up that wouldn?t stop. They treated me with pain medication, solumedrol, benedryl and epinephrine. On March 24th I was able to see the allergist Dr and he treated me with 2 antihistamines and steroid. 3 days later I was worse so he saw me again and gave me injection of dexamethazone steroid shot. That helped me get through the weekend. So by the next week he dropped to taking 6mg if dexamethazone and continuing this whole time with the antihistamine regimens he prescribed. Dr has diagnosed me with a ?type IV delayed allergic reaction?. Unfortunately these take weeks or even a couple months to resolve. It calms and flares again repeatedly.
52 2021-04-02 pain in extremity Fever started at 2:46 am, over the course of the next 36 hours the fever got up to 102.9. Severe hea... Read more
Fever started at 2:46 am, over the course of the next 36 hours the fever got up to 102.9. Severe headache and head pains started later at about 6:00 am. Body aches and left arm was sore. Soreness in the left armpit and behind my head lower down on both sides. I took Tylenol every four hours when the symptoms started to control the fever and head pain. Two days post injection, 4/3/21 in the am my fever was about 100.4, it is now the afternoon and my fever is 98.8, still some slight head pain and ache in my arm and armpit.
52 2021-04-02 tingling Low Grade Fever, Body aches, chills, headache, tingling in face and lips
52 2021-04-02 paralysis, bell's palsy, numbness Bells Palsey left side face, numbness, slight paralysis- took Benadryl when I got home.
52 2021-04-02 cold extremities 9:30- started body aches, chills, cold hands 11:00-started fever, 100.5, headache, pain in every jo... Read more
9:30- started body aches, chills, cold hands 11:00-started fever, 100.5, headache, pain in every joint, skin painful to touch, especially my legs These events lasted through the next 24 hours Temperature went up to 101.9. Frequent and sudden need for urination, (hourly for about 16 hours) On 3/11/2021 I woke with extreme pain in my jaw joints that lasted about 4 hours. Around 12:00 pm fever, headache and chills subsided. By approximately 4:00 pm all symptoms had stopped.
52 2021-04-03 flushing While receiving the vaccine, I immediately had a rush of a strong metallic taste in my mouth. I equa... Read more
While receiving the vaccine, I immediately had a rush of a strong metallic taste in my mouth. I equally had a metallic odor in my nose. Within 5 minutes of receiving the vaccine, I experienced flushing and a headache (only on the left side of my head.) My arm at the injection site grew progressively painful (I did not have any redness or bruising at the site.) The headache subsided after approximately 20 minutes; the flushing went away within a couple of hours of receiving the vaccine. Several hours after receiving the vaccine, I developed some minor itching. My arm continued to hurt more at the injection site (I never developed any redness or bruising at the site.) I experienced body aches and general malaise (as I was informed was to be expected.) I continued to have the strong metallic taste in my mouth into the evening and nighttime hours following the vaccine. During the night (approximately 9 hours after receiving the vaccine,) I awoke to an unfamiliar odor, and feeling nauseous. The odor was emitted from my skin. It has been approximately 72 hours since I received the Pfizer COVID vaccine. The skin odor and metallic state have lessened, but are still persistent.
52 2021-04-03 pain in extremity I had a sore arm for four days, fatigue starting on day 2, vomiting with fever and chills starting o... Read more
I had a sore arm for four days, fatigue starting on day 2, vomiting with fever and chills starting on day 3. By day 4, it was back to sore arm and fatigue. Fatigue lasted about a week.
52 2021-04-03 pain in extremity Mild pain in arm
52 2021-04-04 weakness Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: The patient's blood pressure was monitored and was normal. The heart rate was 67. 911 was called out extreme caution on the request of the patient and the medics evaluted her blood pressure and sugar and found all her vitals as normal. She left the store along with her escort without any further issues.
52 2021-04-04 feeling jittery, pain in extremity Fatigue, my arm is painfully sore and uncoordinated dizziness, i had jittery and shaking feeling at ... Read more
Fatigue, my arm is painfully sore and uncoordinated dizziness, i had jittery and shaking feeling at first.
52 2021-04-04 feeling jittery Swollen hands and feet, high blood pressure, jitters, insomnia for 7 days.
52 2021-04-04 pain in extremity, feeling jittery Sore Arm immediately. Body aches, chills, sweats, high blood pressure 156/105, sore joints, severe h... Read more
Sore Arm immediately. Body aches, chills, sweats, high blood pressure 156/105, sore joints, severe headache, nausea, swollen glands in neck and under arm pits and in breasts, could not lift arms without pain, walking hurt, swallowing hurt, chest and ribs hurt to breathe, insomnia, jitters, entire body was in pain, every ounce of my body and it hurt to even roll over in bed or get up and walk. This lasted for 5 days in a row and started the evening that I got the shot. I was perfectly well before the shot.
52 2021-04-04 tingling Severe tinnitus: Two days after receiving my first dose of the Pfizer Covid19 vaccine, the pre-exist... Read more
Severe tinnitus: Two days after receiving my first dose of the Pfizer Covid19 vaccine, the pre-existing tinnitus in my left ear, which has been stable and very mild for 35+ years, suddenly spiked to an almost unbearable level. It has remained consistently high ever since. New tinnitus symptoms presented in my right ear at the same time. I also experienced a sudden decline in my hearing acuity. I additionally experienced tingling and muscle weakness in my face, which has since resolved. However the severe tinnitus remains.
52 2021-04-05 weakness, tremor, feeling cold About 2Am I could not sleep it did not feel like anxiety or insomnia. I was awake then I started to ... Read more
About 2Am I could not sleep it did not feel like anxiety or insomnia. I was awake then I started to get very cold then my body was shaking uncontrollably. My teeth were chattering this was not a chill it was 3-4 hours of intense fear. This stopped and my body turned rather red and was very hot to the touch this was about 3 hours. I could not get in the shower to warm up when I was cold I was too weak. Then about 11-1 the next day it all stopped. It was really frightening and kind of like a PTSD moment for me that caused increased anxiety.
52 2021-04-05 hot flush, tremor About 3 hrs after my vaccine, I first felt like I had a hot flash, then a few minutes later I got ex... Read more
About 3 hrs after my vaccine, I first felt like I had a hot flash, then a few minutes later I got extremely dizzy I couldn't even hold my head up, I was visibly shaking like tremors, I was pale, had a low grade fever, was nauseas and vomitted one time. All of this lasted only one to 2 hours except for the nausea, which lasted 2 days however after the initial 2 hour period it was not that bad, just a little queasy feeling. The onset really felt like my blood sugar bottomed out.
52 2021-04-05 numbness Numbness on the left upper extremities/face reported about 1.5 hours after vaccine administration
52 2021-04-05 muscle spasms For 3 weeks now, I have had loose stools. I have had between 3 to 5 bowel movements a day. They are... Read more
For 3 weeks now, I have had loose stools. I have had between 3 to 5 bowel movements a day. They are usually immediately following eating. Because of my dairy allergy and some anxiety I have been experiencing, I didn?t think about this all being connected to the vaccine. I have never had loose bowel movements that have lasted like this unless I was sick with something else. Today, I am experiencing some cramping with it as well. I read about an ingredient in the vaccine that may cause this so I decided to contact someone.
52 2021-04-05 pain in extremity, breast pain, burning sensation Vaccine 2 Sore arm quickly Headache Done at 3:11 (could go home) Ear pain then gone Neck pain then ... Read more
Vaccine 2 Sore arm quickly Headache Done at 3:11 (could go home) Ear pain then gone Neck pain then gone Right breast hurts outside side then gone Headache again then gone Headache again 449 97.9 temp Eyes sore 5:25 98 temp 7pm two Tylenol Feeling heavy head and arm and shoulder sore. Little congestion Ears popped Dizzy Went to sleep at 8pm Swollen tongue and throat 10pm Left arm sore forearm Broken toe kinda burns a little Sat was miserable ?kept falling alseep Sunday was a little better but still all the same issues Digestive issues as well? Did not go away until around noon Tuesday the 30th Finally worked and went to gym on Wed but still sore eyes and throat slight soreness. Like having mono. Super crusty eyes each morning and using saline solution since we started distance learning Worked in person TH and F and went to gym Th and Sat. Woke up with super pain in sinuses Sunday Bleb in right eye Sinus pressure that usually indicates an infection? Went to Dr Monday for pressure and eye Bleb and got prednisone and an an allergy eye drop. Sinus pressure is a little less as I started prednisone this morning.
52 2021-04-05 pain in extremity 34 hours post vaccine, my ears started ringing loudly. It is now two days later and they are still ... Read more
34 hours post vaccine, my ears started ringing loudly. It is now two days later and they are still ringing, same level. This has been my only side effect other than a sore arm.
52 2021-04-05 tingling Itchiness, prickliness, all over, despite 3 showers in 24 hours. No visible rash. Just tingly lik... Read more
Itchiness, prickliness, all over, despite 3 showers in 24 hours. No visible rash. Just tingly like pins and needles. Mild but noticeable. Happened late afternoon into evening and still true as I prepare to sleep.
52 2021-04-05 throat numbness Numbness in mouth, lips and moving toward back of the throat and up sinuses. headache and fatigue Th... Read more
Numbness in mouth, lips and moving toward back of the throat and up sinuses. headache and fatigue These symptoms were present 4 hours after 2nd Pfizer vaccine- treatment was steroid shot and benadryl tablets these symptoms reappeared 2 weeks after 2nd shot. treating with benadryl tablets and symptoms mildly improving
52 2021-04-05 tremor I started the heaviest and most painful menstrual cycle I?ve ever had. Heavy bleeding for five days ... Read more
I started the heaviest and most painful menstrual cycle I?ve ever had. Heavy bleeding for five days and no sign of stopping. Cramping so badly that I was shaking with pain at one point
52 2021-04-06 weakness, pain in extremity weakness; nausea/her stomach is kind of queasy; She spent 2 days in bed, unable to get out to do any... Read more
weakness; nausea/her stomach is kind of queasy; She spent 2 days in bed, unable to get out to do anything other than pee, get something to eat and go back to bed; brain fog; she can't concentrate, it is affecting her head; dizziness/dizzy; exhausted/tiredness/tired; faint episode; achy arm; abdominal pain; her sugars really shot up in couple of hours, went to 220s; shivers, cold.; shivers, cold.; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [22Mar2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 18Mar2021 (at the age of 52-year-old) at single dose for COVID-19 immunization. Medical history included Diabetes, ongoing PoTS diagnosed around Dec2020 or Jan2021, MTHFR (methylenetetrahydrofolate reductase genetic mutation) genetic mutation, Genetic/Chromosomal abnormalities and lost some weight. The patient had prediabetes for long time, in last year gotten little bit bad; back under control sugars running 125-130. That's not why she is feeling like this. Measures her sugar 3 times daily keeps Diabetes diet controlled mostly. With regards to her MTHFR: methylenetetrahydrofolate reductase genetic mutation. This genetic mutation makes her not methylate well, they told her she is a poor meythelator. Family history included diabetes and high blood pressure. Her dad passed away from either Diabetes or Lung cancer; she is not sure which-he had lung cancer but afterwards when patient talked to her sister, sister mentioned dad's diabetes got really bad after the chemo and everything; but that is neither here nor there in the end; it could have been from Diabetes or lung cancer. He was a smoker for his entire life, even though chemo he could not quit the cigarettes, could not give it up even on his death bed. Concomitant medications included ergocalciferol (VIT D), cyanocobalamin (VIT B12), and ongoing ascorbic acid (VITAMIN C); all were taken for vitamin supplementation. The patient previously received varicella zoster vaccine rge (cho) (SHINGRIX) on 19Feb2021 for immunization and experienced achy arm and tired for a day. About 15 years ago when having her daughter, the patient had severe reaction to Magnesium sulfate for preeclampsia. They gave her Magnesium sulfate twice which made her comatose twice, she does not know why they gave it to her the second time. She also had a reaction to calcium levomefolate (DEPLIN), like a methylfolate thing. She reported she was on Glimepiride for Diabetes previously which was stopped a couple of weeks ago because she was having a lot of blood sugars that did not sit well with her. This consumer is the patient who called regarding symptoms she experienced following first dose of Pfizer-BioNTech COVID-19 Vaccine administration on 18Mar2021. The first symptoms she had were an achy arm later on that day of 18Mar2021. On 19Mar2021, the next morning she woke up totally exhausted. She spent 2 days in bed, unable to get out to do anything other than pee, get something to eat and go back to bed. Some of the symptoms lifted yesterday, 21Mar2021 during the day. She kind of got up, was still kind of tired but pushed through it thinking she couldn't just sit in bed. She spent a little time outside while her daughter was at the pool; she was sitting in a chair away from other people. When she came home she was really tired and dizzy on 21Mar2021 and decided to go to bed. The patient also experienced weakness and nausea on unspecified date. After the Pfizer BioNTech COVID-19 Vaccine injection/shot on Thursday, 18Mar2021 she had a faint episode. They thought the faint episode was probably from anxiety, reason unknown; but she had a lot of faint episodes before she went to bed. She woke up 1-2 hours later on 18Mar2021 with really bad abdominal pain all night, shivers, cold. When she got up in the morning she was really tired; she had to take her daughter to school and barely drove to school half-way coherent because her daughter was talking to her. She was not doing great, she came back home, she is still tired, has been on the couch all day; her stomach is kind of queasy, not good. This is day 4 so she is concerned a little bit. She is too tired to go downstairs during this call; this thing is kicking her butt; she is having a brain fog with this thing, she can't concentrate, it is affecting her head. She has other medical condition Diabetes: After she got the Pfizer-BioNTech COVID-19 Vaccine her sugars really shot up in couple of hours, went to 220s on 18Mar2021; sugars back down the next day (19Mar2021). She is terrified of what is going to happen after the second dose of Pfizer-BioNTech COVID-19 Vaccine. She verified she has not had any visit to physician's office, emergency room or hospitalization related to these events; not yet, but she is considering whether to go or not. The outcome of the event exhausted/tiredness/tired was not recovered, and the outcome of the remaining events was unknown. Information about the Lot/batch number has been requested.
52 2021-04-06 weakness Weakness, difficulty breathing. Lasted 3 days. Deep cough and lethargic still. Over a week later. ... Read more
Weakness, difficulty breathing. Lasted 3 days. Deep cough and lethargic still. Over a week later. Contact pc and advised if symptoms got worse to go to er. Not worse but won't go away
52 2021-04-06 cold sweat Cold, clammy to the touch, feeling faint. B/P 105/78, HR 69, O2Sat 98%.
52 2021-04-06 mild one side paralysis, facial paralysis, numbness Patient was observed for 30 min after her second dose of covid-19 vaccine (note patient decided to t... Read more
Patient was observed for 30 min after her second dose of covid-19 vaccine (note patient decided to take diphenhydramine immediately after receiving this dose of vaccine because she experienced a spike in her blood pressure with her first covid-19 vaccine). Patient felt fine and left the vaccine clinic. But about 2 hours after receiving the second dose, patient developed numbness, right upper and lower extremity weakness and headache. Upon presentation to the ED, patient developed right sided facial droop and ongoing right upper and lower extremity weakness and headache. Stroke protocols were initiated including offering tPA for clinical stroke, but patient declined it. At workup, her EKG showed a sinus rhythm, she had not reported recent illness. A CT angiogram showed no significant flow limiting stenosis either in the neck or head and there was no perfusion deficit. However, incidental bilateral aneurysms were discovered at the anterior cerebral arteries at the junction of the A3 segments and pericallosal arteries. There was no evidence that they had hemorrhage and they are small, less than 5 mm in diameter and neurosurgery has evaluated the patient and is not recommending any urgent intervention. The next day the patient was doing well, presenting symptoms/deficits resolved except for ongoing mild headache. An MRI examination of the brain has shown no acute infarct and normal brain morphology was described. She had an echocardiogram, which showed grossly normal left ventricular size and systolic function with an estimated ejection fraction of 65%. Amlodipine was started for elevated blood pressure. Note: patient had a history of hypertension but was not on medications for this prior to admission. Neurology consult = ?This is a peculiar event. It is unclear if the patient had a TIA or COVID reaction to a COVID vaccination or a reaction to headache. She does not exhibit a completed stroke on MRI scan. She has recovered completely except for mild headache. Incidental aneurysms were discovered and at some point she should have follow up for that. She should have a follow up with the stroke service. In the meantime, I think it is reasonable to continue with daily aspirin on this patient. Note that she had a cryptogenic TIA.?
52 2021-04-06 numbness fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then ... Read more
fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; This is a spontaneous report received from a contactable nurse (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 12Mar2021 at 09:30 (at the age of 52 years) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 12Mar2021, the symptoms the patient had were fainting, feeling dizzy, tachycardia, high blood pressure, then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any treatment for the events (as reported). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel in Mar2021. Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event fainting cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-04-06 pain in extremity, tingling, feeling cold At 3:30 pm, pain in left side under ear/jaw area, pins and needles in jaw area starting. By 5:30 pm,... Read more
At 3:30 pm, pain in left side under ear/jaw area, pins and needles in jaw area starting. By 5:30 pm, pins and needles moving between jaw, top of head, left finger tips, and left cheek/sinus area. Took 1 Ibuprofen for neck/arm pain. Laid down at 5:30 pm. Fatigue. Cold enough to get a blanket but no chills. Laid down rest of the evening until bedtime. Woke up many times overnight from arm pain.
52 2021-04-06 pain in extremity This is a spontaneous report from a contactable consumer. A 52-year-old non-pregnant female patient ... Read more
This is a spontaneous report from a contactable consumer. A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm left on 17Feb2021 at 10:30AM as a single dose for COVID-19 immunization. Medical history included Known allergies: Penicillin. Concomitant medications included plecanatide (TRULANCE) for an unspecified indication. Historical drug included BNT162B2 on 20Jan2021 at10:30 AM. The patient experienced Arm/shoulder pain - diminished mostly after 4 days, "Foggy" thinking. Shoulder pain is worse at night, difficult to sleep, Six days after vaccine, still "foggy." Not just sleepy from lack of sleep on 17Feb2021 at 2:00. Taking oral steroids and it is improving. The patient has said that It worsened for a couple days, then started to get better after about 4 days. Then it started worsening probably on 22Feb2021. Patient went to the doctor 26Feb2021. Seems the inflammation went into my rotator cuff. Taking oral steroids and it is improving. The outcome of event was recovering. Information on the lot/batch number has been requested.
52 2021-04-06 tingling parathesis - numb skin
52 2021-04-06 tingling At 4am the day following the shot I woke up diarrhea, vomiting, a fever (101.4), chills/sweating, sq... Read more
At 4am the day following the shot I woke up diarrhea, vomiting, a fever (101.4), chills/sweating, squeezing chest pain, tightness in throat, swelling of hands/feet, joint pain and throbbing headache- by later in the day I had also developed a blister type rash on my upper butt crack. I got the shot on Weds- symptoms finally subsided by Sunday evening except the rash which on Sunday had crusted over and is now/currently dark red, flat and feels sore/tingly. I'm currently waiting f or a return call from my doctors office about how to treat the rash. This rash looks very similar to shingles. My 18 yr old daughter got the shot one day before me and has this same rash on her cheek.
52 2021-04-07 hot flush, muscle spasms All start upon waking in the morning and last off and on throughout the day. Took Tylenol and Alle... Read more
All start upon waking in the morning and last off and on throughout the day. Took Tylenol and Allegra Excessive hot flashes Chills Body ache Muscle spasms in left arm Sore scratchy throat Mild cough Exhaustion Headache
52 2021-04-07 numbness Numbness of upper lip and lower part of nose. The upper lip was swollen. The numbness lasted for a... Read more
Numbness of upper lip and lower part of nose. The upper lip was swollen. The numbness lasted for approximately 12 hours. The lip was swollen for 3 days.
52 2021-04-07 pain in extremity Started to feel soreness in arm and throat about an hour after shot. Sore throat got worse overnight... Read more
Started to feel soreness in arm and throat about an hour after shot. Sore throat got worse overnight and worst one I?ve ever had hard times swallowing feels like throat is swollen but still able to breathe. A little stuffy and runny nose and ear soreness on left side. Drank emergen C in water and took a couple throat lozenges. Took a Tylenol for muscle pain last night around 9:30pm
52 2021-04-07 tingling, breast pain Sharp pains in left breast first 3 days after shot - This has gone away Tingling in left arm and h... Read more
Sharp pains in left breast first 3 days after shot - This has gone away Tingling in left arm and hand - day 3 - this has subsided Tingling and itchy feeling of face, head, feet and sometimes lower legs. - this continues Knotted feeling in middle of chest - sometimes feel short of breath, but doesn't get worse with exertion - this continues General fatigue - first few days - this has subsided
52 2021-04-07 tingling, flushing, discomfort About 20 minutes after vaccine given, complained of discomfort, face flushed, facial and upper arms ... Read more
About 20 minutes after vaccine given, complained of discomfort, face flushed, facial and upper arms with paresthesias. Vital signs normal aside from mild hypertension. Improved.
52 2021-04-08 bell's palsy, facial paralysis Left sided facial droop diagnosed as Bell's palsy
52 2021-04-08 numbness 20minutes after 1st shot lips & face became numb. Resolved after about 1 hour.
52 2021-04-08 migraine Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressu... Read more
Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressure the next two days after I had really bad migraine and high fever of 102.3° with bad fatigue for 4 days.
52 2021-04-08 pain in extremity Woke up the next day with chills, fever, headache, extreme fatigue, mild wheezing (took Zyrtec), mod... Read more
Woke up the next day with chills, fever, headache, extreme fatigue, mild wheezing (took Zyrtec), moderate arm pain. Felt somewhat better in the afternoon. This repeated for the next two days, with the morning symptoms getting milder each day. Felt fine on the fourth day.
52 2021-04-08 pain in extremity Joint pain and mild headache for 24 hours, sore arm for about 3 days, fatigue and autoimmune flare f... Read more
Joint pain and mild headache for 24 hours, sore arm for about 3 days, fatigue and autoimmune flare for about 10 days
52 2021-04-08 pain in extremity On day 1 injection day, sore arm; day 2 sore body and throat; day 2-3 blisters at the edge of my mou... Read more
On day 1 injection day, sore arm; day 2 sore body and throat; day 2-3 blisters at the edge of my mouth which is very unusual as I don?t get cold sores.
52 2021-04-08 speech disorder Confusion, extremely severe ringing in ears, lisping
52 2021-04-09 weakness, tingling, pain in extremity got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up;... Read more
got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up; chest pain in my right side; my left leg started aching; my toes tingle like they have fallen asleep on that left side; heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing; heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing; Redness; back was all red, really red; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 01Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer reporting for herself. This 52 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 31Mar2021 at 09:30, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the vaccine on 31Mar2021 at 9:30 and was fine all day until 7 o'clock at night. She went to take her shower and got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up, so she got out of the shower, went upstairs; the weakness persisted and then she started feeling chest pain in her right side, her left leg started aching and her toes tingled like they had fallen asleep on that left side so she got scared and went to the emergency room where they kept her overnight. Her heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing and that was why they kept her at the hospital. She also had redness, her back was all red, really red. They did lots of lab work and blood work, a stress test, an ultrasound on her left leg for blood clot and a CAT scan on her heart, all with unknown results. When probed about hospitalization, she stated to stay overnight. She was hospitalized on 31May2021 at about 19:30 and did not get out until 13:30 on 01Apr2021. Events outcome was unknown.
52 2021-04-09 numbness Within 5 minutes after my injection my lips and nose became numb/numbing went up my cheek, forehead;... Read more
Within 5 minutes after my injection my lips and nose became numb/numbing went up my cheek, forehead; Headache; a metallic taste in my mouth; my blood pressure was 180/100; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiration date: unknown), via an unspecified route of administration on 21Feb2021 12:00 on left arm at single dose for COVID-19 immunisation. Medical history included Low Thyroid and allergies to Ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient not diagnosed with COVID-19.Since the vaccination the patient had not been tested for COVID-19. Concomitant medication included Levothyroxine. On 21-Feb-2021 12:00 PM (Within 5 minutes after injection), patient experienced her lips and nose became numb. A nurse brought patient to a doctor where the numbing went up my cheek, forehead, my teeth after almost 5 hours patient was still numb. Patient also had a sight sore throat headache; blood pressure was 180/100 and had a metallic taste in my mouth. Patient visited the physician office but did not received any treatment for events. The outcome of event was recovering. No follow-up attempts are possible. No further information is expected.
52 2021-04-09 muscle spasms, tingling, pain in extremity 4/9 4:25pm: runny nose, headache, stuffy sinuses/pain- went away after 15 minutes 4/9 11:06pm: woke... Read more
4/9 4:25pm: runny nose, headache, stuffy sinuses/pain- went away after 15 minutes 4/9 11:06pm: woke up to speeding heart rate, labored breathing, thumb joint left hand hurts/pain, stomach nausea, racing in stomach, neck itchy, pin prickly hands and legs 4/10 4am: hand joints very stiff, can?t close hands, fingers extremely swollen and painful, injection site - severe pain, thirsty, dehydrated 4/10 7am: neck severely itchy, hands feels like they?re going to explode from pressure- swelling and red with pain, severely dehydrated, coated tongue and disgusting taste in mouth, feel nauseous, multiple head spasms continuing at approximately 15 min intervals, scalp itchy, pain at injection site
52 2021-04-09 tremor On April 26th, I had fever, chill's, nausea and body aches. It took over the whole weekend for the ... Read more
On April 26th, I had fever, chill's, nausea and body aches. It took over the whole weekend for the body aches to subside. The nausea has still not gone away. I have noticed that I have started and now lost my ability to spell. I can see the word but I have a hard time getting out. I am now experience sever tremors.
52 2021-04-10 tingling 3 minutes after the shot I had a tingly and at times itchy sensation in my left hand, 16 minutes aft... Read more
3 minutes after the shot I had a tingly and at times itchy sensation in my left hand, 16 minutes after the shot I started coughing (I had not coughed prior to the shot). About 2 hours later I started feeling blah (you know How sometimes you feel just blah) and tired but I was able to continue work. This I took a nap around 2pm and felt better when I woke up. Around 7pm started feeling blah and tired again so I went to bed. Woke up Saturday and I felt fine. However during the day i would alternate between blah and fine. However I was still able to continue with Norman activities. Woke up today, Sunday, feeling great.
52 2021-04-11 inability to speak Pt received 1st dose of Pfizer dose. Allergies to iodine. Pt started exhibiting difficulty swallowin... Read more
Pt received 1st dose of Pfizer dose. Allergies to iodine. Pt started exhibiting difficulty swallowing. Pt was able to talk. BP 172/97. HR 78. SaO2 99%. Paramedics stayed with pt for 20 minutes until pt said the feeling had passed and she was able to drive home. Zero reports of difficulty breathing, no drop in SaO2
52 2021-04-11 burning sensation Rash - started as warm raised area on right shoulder just above scapula near neck, mild itchiness, b... Read more
Rash - started as warm raised area on right shoulder just above scapula near neck, mild itchiness, burning, aching. Developed low grade fever, swollen/hard lymph nodes in my neck, rash resembled ringworm at first, now has scabbed areas where blisters would be, painful. I have never had chickenpox, was vaccinated as a child and titers show positive for immunity. I was diagnosed as having shingles at urgent care, and currently taking PO valacyclovir. I received the 2 nd dose of pfizer vaccination on 2/24/2021 and developed first sx approximately 4/6/21
52 2021-04-11 numbness Lips, tongue, face, hands went numb/tingling. Hands sweating. 2 doses of Benadryl. Went to hospital.... Read more
Lips, tongue, face, hands went numb/tingling. Hands sweating. 2 doses of Benadryl. Went to hospital. Hospital gave me steroids.4-6-2021 Still having some reactions - continue taking Benadryl
52 2021-04-11 pain in extremity, cold extremities Felt arm slightly cold running down toward fingers. Slight nausea. Arm became progressively painful ... Read more
Felt arm slightly cold running down toward fingers. Slight nausea. Arm became progressively painful from site of injection down to fingers. Unable to sleep, swelling along arm down to fingers. Swelling going down very slowly, can now bend elbow and make fist but still painful if used.
52 2021-04-11 tremor, burning sensation I was tested for Covid in January 2021 and had symptoms for approx. 6 weeks. After approx. 9 hours a... Read more
I was tested for Covid in January 2021 and had symptoms for approx. 6 weeks. After approx. 9 hours after receiving my first Pfizer vaccination shot I took a shower and shortly afterwards started shaking uncontrollably. It was not like shivers from a fever. My entire body shook for approximately 1 1/2 hours laying in bed. It stopped completely then I had a hot/burning sensation on my face and ears for approx an hour. I drifted off to sleep. The next morning I felt muscle soreness and tiredness most likely from the shaking. This is the first time ever having the shakes. I had shivers and chills when I had Covid but this was much worse than shivers. Today is five days after the shot and having this reaction and I am feeling ok. I do not have any serious health conditions. I do have history of high blood pressure, IBS and migraines.
52 2021-04-12 cold sweat, numbness I started my period three days after I got vaccinated. I do have a heavy period because of uterine f... Read more
I started my period three days after I got vaccinated. I do have a heavy period because of uterine fibroids but this time it was even heavier than usual. Every hour, I had to change a blood-soaked overnight pad during the first night. After one night and a day of bleeding, on the second night, I had a near faint experience and I collapsed on the bathroom floor with nausea, cold sweating, hands numbing, short of breath. My husband called an ambulance and I was transported to ER. ER gave me fluid and did a blood check and gave me a medicine to reduce bleeding. I was discharged a few hours later. I am still bleeding but the amount is less. I have never experienced this severe period till I experience near faint.
52 2021-04-12 cold sweat, unresponsive to stimuli After vaccine I was told to wait 30 minutes and I started feeling woozy/a mild nausea and broke out ... Read more
After vaccine I was told to wait 30 minutes and I started feeling woozy/a mild nausea and broke out into cold sweats a few minutes later. I got up and told the nurses at Medical Center (site in which I received vaccine) that I felt like I was going to faint. I was instructed to lay down on floor and they put my legs on a pillow. I next recall being blood pressure cuffed and them saying my BP was rather low. I was also very thirsty. I was told I wasn't responding for a few (smelling salts were used) I then was instructed to sit up but my BP was low and I felt dizzy. It was then decided I should be wheeled to the ER for observation. I was in a room where they took my EKG which turned out fine and I was given an IV flush and hydrated. I had blood work done and all was well so I was released a few hours later.
52 2021-04-12 night sweats Sore throat, fatigue, body aches, fever, swollen lymph nodes - bilateral neck, night sweats, diarrhe... Read more
Sore throat, fatigue, body aches, fever, swollen lymph nodes - bilateral neck, night sweats, diarrhea.
52 2021-04-12 pain in extremity Patient had vaccine Friday, started having calf pain Saturday and diagnosed with DVT Sunday. This is... Read more
Patient had vaccine Friday, started having calf pain Saturday and diagnosed with DVT Sunday. This is in the setting of recently starting OCPs (high dose for 1 week then on regular dose at time of DVT) and some increased sedentary status due to menorrhagia. Unsure if this is related to vaccine but felt necessary to report.
52 2021-04-13 weakness headache, nausea, generalized weakness, dizziness
52 2021-04-13 weakness 11 am severe nausea, headache, balance problems. by 1pm Vomiting started, headache got worse by 4 ... Read more
11 am severe nausea, headache, balance problems. by 1pm Vomiting started, headache got worse by 4 tingling sension and headache and vomiting continued Around 4am slight fever, vomiting continued Next day vomiting stops mid day, still some balance problems very weak , dizzy ness, balance problems headaches Day 3 still slight headache, light bothering eyes waves of nausue throughout the day extremely tired Day 4 Extremely tired, nausea wave 1 or 2 times but able to eat, slight headache, balance normal Day 5 slight headache , tired
52 2021-04-13 weakness Facial swelling, throat irritation, weakness, profuse sweating.
52 2021-04-13 weakness Fever, no energy, rundown feeling, headache, sore injection site, nauseous, and blood vessel in fing... Read more
Fever, no energy, rundown feeling, headache, sore injection site, nauseous, and blood vessel in finger burst.
52 2021-04-13 tingling Lightheaded/dizzy, toes tingling. Resolved with monitoring within 30 min.
52 2021-04-13 speech disorder Patient reported anaphylactic reaction to a dose of Influenza vaccine 16 years ago. Per Pfizer EUA ... Read more
Patient reported anaphylactic reaction to a dose of Influenza vaccine 16 years ago. Per Pfizer EUA guidelines, patient was observed for over 30 minutes following the administration of Covid-19 vaccine dose, given at 13:35. At 16:40 patient noticed voice changes while talking on the phone and increased throat irritation. Patients vital were as follows: Pulse 120 / BP 124/64 at 16:42. EpiPen 0.3mg was administered at 16:43. IV placed in A/C by onsite EMS and a dose of Diphenhydramine 50mg was also administered intravenously. Patient was take to ER.
52 2021-04-14 inability to speak All symptoms last for about 1.5 hours. Lightheaded, foggy vision and weakness in the legs: felt like... Read more
All symptoms last for about 1.5 hours. Lightheaded, foggy vision and weakness in the legs: felt like going to faint.=> washed face and hands with cold water and these feelings disappeared. Then periodic palpitations started, each serious was weaker until they disappeared after about an hour. During the palpitations, felt weakness/ numbness in the low jaw and low lip with difficulties to talk but it lasted only for number of seconds. The last symptom during that 1.5 hour was some warm feeling in the inner part of the leg (thigh and calf) and the outer side of the legs filled just as normal. I di have some tightness in the chest with difficulties to have a deep breath but it was't significant while I was driving home
52 2021-04-14 weakness, tingling 04.06.21 I received my 1st Pfizer shot at 3pm. At 5pm, I had a headache, my neck was hurting and I b... Read more
04.06.21 I received my 1st Pfizer shot at 3pm. At 5pm, I had a headache, my neck was hurting and I began feeling so weak I could barely talk, I couldn't hold my eyes open. I took 3 Aleve. At 8pm, I started with shortness of breath just going downstairs plus my entire body felt like I was hit by a truck. My 3lb. Chihuahua would get on me and it felt like I was hit by a bat with a ripple effect into the surrounding area. I took 2 Tylenol PMs. On 04/07, at 6am, I woke up to my limbs extremely swollen and throbbing, this included both feet and especially both wrists and hands. My hands were worse than my feet. My left wrist/hand also had tingling. I was so weak I could barely get out of bed or talk, this continued through to 5:30pm same day. I called an Urgent Clinic and told her all my symptoms, she said were all "normal" until I got to my wrists/hands and limbs. Urgent Care told me it would be best to be seen in ER and evaluated. I immediately went to ER . This approximate time was 6:30pm on 04/07/21.
52 2021-04-14 feeling hot, flushing Injection was at 12 PM. At 12:15 PM I started to feel a furry throat like I had a hairball in my thr... Read more
Injection was at 12 PM. At 12:15 PM I started to feel a furry throat like I had a hairball in my throat and a tickle. Within a minute or so I got a cough, a dry cough with a high pitch. I could not stop coughing. My face felt hot and was flushed, my lips tingly, and I started to sweat a lot. I was short of breath when I tried to talk. The staff on site put an oximeter on and my oxygen was fine but my pulse rate was around 130. My nose was dripping snot and my eyes were running. We walked over to ER which was just around the corner, And sat in the waiting room for about 10 minutes wondering if the cough and symptoms would update. I Peed my pants a little bit. I started to feel very nauseous and little bit scared, even though this has happened to me before. I was brought to a room and soon given a dose of Epi as well as Pepcid (about 1pm) soon after some Zofran. The epi took care of my symptoms within about five minutes. About 90 mins later symptoms came back full on and I was given another dose of Epi at almost 3pm. And agin at 630pm.
52 2021-04-14 pain in extremity Severe arm and shoulder pain. Throbbing continuous pain in my shoulder and upper right shoulder blad... Read more
Severe arm and shoulder pain. Throbbing continuous pain in my shoulder and upper right shoulder blade. Mobility restricted. 17 days later my shoulder is still hurting. I've treated with heat, ice, Aleve, Arincare gel, massage and rest.
52 2021-04-14 tingling, feeling hot, electric shock sensation Within 5 to 10 minutes I had tingling in left hand (my husband had his 5 minutes after mine and had ... Read more
Within 5 to 10 minutes I had tingling in left hand (my husband had his 5 minutes after mine and had that too), but I had red fingers tips that were hot and toes. Later that night we both had electrical shocks/bites here and there in head and body. 14 days later WE BOTH felt like we were run over by a truck for a day and with horrific headaches. I got tested for covid, in case, and it was negative. 2 days later those symptoms were gone....but FOR ME...I began having a buzzing/strong vibration in my left chest. It's like a cell phone is on vibrate strongly on my chest. It happens every 2 to 10 minutes and has been constant since. Still have it. I am supposed to have the 2nd shot in 5 days, not sure if I should. Need to know if anyone else has reported these symptoms.
52 2021-04-14 tingling 1st shot sore are tire for 2 days 2nd shot tired on the 2nd day 3rd day start getting getting headac... Read more
1st shot sore are tire for 2 days 2nd shot tired on the 2nd day 3rd day start getting getting headache, dizzy, nausea, sick to my stomach, tightness of chest, rapid heartbeat on and off, couldn't eat, didn't sleep well, tingling in hands and feet, didn't feel like I was going to make it through though the night. Not bad enough to go to the emergency room. I have been to urgent care and to internal medical to get checked still not feeling good I had covid in December and I feel like this shot has made me sick and I just can't get back to myself
52 2021-04-14 throat numbness Employee taken to the ED. 52 y.o. female presenting with numbness and tingling around her throat, t... Read more
Employee taken to the ED. 52 y.o. female presenting with numbness and tingling around her throat, tongue, and lips after receiving the first dose of the Pfizer covid vaccine at approximately 12:15 pm and subsequently was sent to the ED about a half hour later. She stated that after receiving the vaccine, her tongue felt "full" and her lips had some tingling - overall it just felt funny. She received 50 mg of Benadryl - this made the numbness and tingling decrease slightly but it hasn't caused it to completely resolve. She also had a slight headache that started shortly after this. She denied any shortness of breath or rash. She has never had any symptoms like this with a previous vaccine although she has had urticaria with penicillins
52 2021-04-15 inability to speak Days 1-2; Extreme fatigue and chills. Day 3: Felt well. Starting on Day 4: Extreme Exhaustion, musc... Read more
Days 1-2; Extreme fatigue and chills. Day 3: Felt well. Starting on Day 4: Extreme Exhaustion, muscle weakness, extreme post-exertional malaise, headache, rash on left cheek, cognitive problems (word-finding difficulty). Symptoms severe for a month, and slow improvement. I'm 2 months out and am at less than 50% of previous activity level. Muscle weakness (especially legs), moderate fatigue, and worsening fatigue after even mild exertion persists. I have had ME/CFS for 25 years, but it was mild/moderate have been at a great functioning level for over 10 years, able to exercise, easily perform ADLS. No problems with muscle weakness, etc.
52 2021-04-15 discomfort 52 y/o female, with past medical history of headaches, who presents with throat tightness and some d... Read more
52 y/o female, with past medical history of headaches, who presents with throat tightness and some discomfort swallowing post vaccination administration. Patient states that she is allergic to PCN. This is the patient?s 2nd vaccination which was applied to the left deltoid. NP and Paramedics at the patient?s side. Patient vitals within normal limits (85 HR, 100% SPO2, 110/72 BP, Resp 10). Patient provided with a bottle of water and 25mg Benadryl PO administered x1. It was explained to patient that if symptoms do not improve with Benadryl then we would have to administer EPI and seek further emergent evaluation. Patient agreed. Patient with resolution of symptoms within 25 minutes of medication administration. Patient discharged home in stable condition.
52 2021-04-15 night sweats About 10 days after the vaccine, I started having shortness of breath, fatigue, night sweats and som... Read more
About 10 days after the vaccine, I started having shortness of breath, fatigue, night sweats and some chest pain. The chest pain is mostly a constant chest discomfort, along with brief sharp or burning pains in the center of my chest. The shortness of breath, night sweats and chest pain have not gotten any better and is still continuing on this day, 4/16. These are new symptoms for me and I felt absolutely fine before getting the vaccine.
52 2021-04-15 pain in extremity 4/3/21 woke up with slight pain in right calf, 4/4/21 woke up with severe pain in right calf, went t... Read more
4/3/21 woke up with slight pain in right calf, 4/4/21 woke up with severe pain in right calf, went to Urgent Care was diagnosed with DVT 7cm started Eliquis for 3 mos, stopped Low Ogestrel
52 2021-04-15 tingling, numbness Bruising and swelling at injection site on left deltoid area / patient also complaining of occasiona... Read more
Bruising and swelling at injection site on left deltoid area / patient also complaining of occasional numbness and tingling almost like arm has fallen asleep and is waking up. Full range of motion is present according to patient. No swelling of fingers or elbow according to patient. Treatment / Patient sent clinic pictures of the bruised area. Recommend ice and Motrin and to come for evaluation. Patient did not return to clinic.
52 2021-04-15 seizure Pt lost consciousness in waiting room unwitnessed by staff. Transferred to the ED. Seizure activity ... Read more
Pt lost consciousness in waiting room unwitnessed by staff. Transferred to the ED. Seizure activity noted.
52 2021-04-16 weakness About 10-15 minutes after receiving the shot, my arm swelled and turned red and hot around the inje... Read more
About 10-15 minutes after receiving the shot, my arm swelled and turned red and hot around the injection site and through my shoulder area. I was in tremendous pain and felt nauseous. I made it home, but had to stop to throw up on the way. When I arrived home, I laid down to rest but the vomiting continued. Within 3 hours, I had severe diarrhea and a terrible headache. Those symptoms lasted for approximately 10 hours, at which point they began to subside. I was very tired and weak for the next 48 hours, at which time I began to feel pretty normal.
52 2021-04-16 cold sweat PFIZER COVID VACCINE ADMINISTERED AT 1:38PM. AT 1:53PM SHE HAD A HARD TIME KEEPING HER BALANCE WHILE... Read more
PFIZER COVID VACCINE ADMINISTERED AT 1:38PM. AT 1:53PM SHE HAD A HARD TIME KEEPING HER BALANCE WHILE WALKING TO THE PHARMACY COUNTER FOR HER VACCINATION CARD. SHE WAS ASKED TO SIT DOWN TO BE MONITOR FOR ANOTHER 30 MINUTES. ABOUT 5 MINUTES LATER I CAME OUT TO CHECK ON HER. SHE WAS TRYING TO DRINK SOME WATER BUT SEEM TO BE CHOKING. SHE WAS GRABBING HER NECK AND LEANING TO HER LEFT. I ASKED IF SHE IS HAVING A HARD TIME BREATHING. SHE REPLIED YES AND SHE I AM IN PAIN. I ASKED MY TECH TO CALL 911. AT 2:06PM I GAVE HER ONE DOSE OF EPIPEN 0.3MG. AT THIS POINT SHE DID NOT COMPLAINT ABOUT HER BRATHING. I ASKED IF SHE STILL HAS A HARD TIME BREATHING SHE JUST COMPLAINT ABOUT THE PAIN. HER SKIN WAS COLD AND CLAMMY. SHE WAS HAVING A HARD TIME SITTING IN THE CHAIR. EMT SHOWED UP AT 2:13PM.
52 2021-04-16 feeling cold Felt cold, tired, fever starting at 99.1 F at 8 AM 4/14/2021, rose to 100.1 F at 4 PM 4/14/2021. N... Read more
Felt cold, tired, fever starting at 99.1 F at 8 AM 4/14/2021, rose to 100.1 F at 4 PM 4/14/2021. No treatment, rested, felt fine the next day (4/15/2021).
52 2021-04-16 flushing Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Flushed / Sweating-Mild, Additional Details... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient's daughter was translating on site at the time of occurence. pt complaint of diffuculty breathing in the waiting room and observed redness on the chest. tongue was not swollen. took patient into separate room and continue to observe patient. patient stated she can breath much better after taking off mask and doesn't want us to call 911 yet. informed that if patient were to leave and having diffuculty breathing at home, she must call 911. she can take benadryl 2 of 25mg Q 6-8 h if rash ob
52 2021-04-16 tingling, numbness left face, arm, leg numbness and tingling
52 2021-04-16 tremor Dizziness, sweating profusely, shaking, the feeling I was gonna pass out & complete loss of skin col... Read more
Dizziness, sweating profusely, shaking, the feeling I was gonna pass out & complete loss of skin color. Shaking so bad I couldn?t hold a cup of water with 2 hands. This lasted for about 15 or 20 minutes. Then off & on for about the next week I would get moments of dizziness & feeling of I might faint, but not so severe as right after the shot.
52 2021-04-17 weakness Restlessness, insomnia I was extremely fidgety all night and unable to settle. My mind seemed calm... Read more
Restlessness, insomnia I was extremely fidgety all night and unable to settle. My mind seemed calm but I couldn?t hold still. I felt a strong need to move my body. I kept thinking this what be what it?s like to be ?crawling out of your skin.? It felt like restless leg syndrome but for my whole body. If I got out of bed and walked around, I was fine. I took Benadryl, hoping it would make me sleepy. It did but it didn?t settle the restlessness. I was so tired but so unable to settle. As a middle-aged woman, I know insomnia that keeps me awake, thinking and alert. This was entirely different. My mind was calm and sleepy but my body wouldn?t settle. I?ve never had this before. I have had a few experiences with something I think is similar to restless legs but that was intermittent and never persisted. Prior to this, 15 and 16 April, I had aches, chills, lethargy, weakness, and burning in my nostrils. All of this seemed very normal for dose 2. I was able to work throughout but took a nap one day.
52 2021-04-17 difficulty speaking, flushing, feeling hot Patient received Pfizer vaccine at approximately 1815 and after about 15 minutes the observer on shi... Read more
Patient received Pfizer vaccine at approximately 1815 and after about 15 minutes the observer on shift noticed that she was clearing her throat. This patient also reported feeling heated and flushed and itchy. Stated history of allergic relation to Baclofen, which caused lightheadedness and syncope. Her chart lists several more allergies. This patient was transported to the ER by one of the vaccinators on shift. This vaccinator reported that by the time they got down to the ER her voice sounded constricted and her breathing difficulty had increased.
52 2021-04-17 migraine woke up next day for work @6am-huge intense migraine. then began nausea & diarrhea until approx 10am... Read more
woke up next day for work @6am-huge intense migraine. then began nausea & diarrhea until approx 10am. no food -only drank water. stayed in bed w migraine until about 6pm.
52 2021-04-17 pain in extremity I have a red swollen, itching place on my left arm where I got the shot , it started getting red aft... Read more
I have a red swollen, itching place on my left arm where I got the shot , it started getting red after I left and it has gotten bigger and he has fever in it.
52 2021-04-17 tingling Patient reported feeling a lot of nausea immediately after receiving the vaccine. Patient reported h... Read more
Patient reported feeling a lot of nausea immediately after receiving the vaccine. Patient reported history of Reynaud's and celiac disease. Patient also began reporting numbness and tingling to face, hands, and feet. Patient began to report an extreme headache to the left side of the head. EMS was called, patient's BP was found to be elevated. Patient was transferred to ED.
52 2021-04-18 numbness Sudden fatigue and lightheadedness. Patient leaned back in car seat and AC turned on. Drank water. H... Read more
Sudden fatigue and lightheadedness. Patient leaned back in car seat and AC turned on. Drank water. HR 70s, O2 98%. CV and lung exam nl. R facial numbness. CN II-VII o/w nl. Symptoms subsided after interventions above.
52 2021-04-18 pain in extremity Arm was sore after 1st shot... 3 days after second shot shoulder joint became sore and still is. Har... Read more
Arm was sore after 1st shot... 3 days after second shot shoulder joint became sore and still is. Hard to move the joint without pain
52 2021-04-18 pain in extremity Pain in left arm slowly began after the vaccine, even though the vaccine was given in the right arm.... Read more
Pain in left arm slowly began after the vaccine, even though the vaccine was given in the right arm. I am right handed. The pain increased to the point of not being able to lift a glass of water with my left hand, use my arm, and the pain awakened me in the middle of the night. It hurt while in a resting position. I have not done anything to strain it following the vaccination. I am sheltering at home, and have lifted nothing heavy, and use my right arm to carry groceries. I only did some light gardening the week before the vaccine, but no heavy lifting or anything that would cause this kind of pain. I took advil, and it made no difference in the pain. Extreme fatigue for three days.
52 2021-04-18 tremor patient received first dose of the pfizer vaccine at 1220. patient was in our observation area and c... Read more
patient received first dose of the pfizer vaccine at 1220. patient was in our observation area and complained of nausea and shakiness to the RN. patient escorted to our clinical area for monitoring and vital signs obtained. patient had been hospitalized in 2/01/2021 for Covid. patient does have allergies to shellfish, nuts, morphine and and anti nausea medications. patient has not other medical conditions noted. patient sister was at bedside with pt. pt recieved 50 mg im benadryl at 1306 called ems at 1315, unit responded at 1318. patient taken to hopsitl by EMS unit
52 2021-04-19 numbness, throat numbness At 10:15, writer arrived to resident's home. Resident made writer aware she was allergic to PNC and ... Read more
At 10:15, writer arrived to resident's home. Resident made writer aware she was allergic to PNC and had a hx of seizure. Writer continued registration process and flagged for 30 minute observation. Resident then received 1st dose of pfizer. Less than two minutes shortly after vaccine was administered resident verbalized that she was feeling numb starting from her throat and moving down her chest. She denied having SOB, was alert and responding to my questions. At 10:35 patient started gasping for air holding her throat. Epi pen was immediately administered to thigh and was not effective. Resident began to seize lasting for about 5 minutes. 911 called at 10:43 am. Resident turned on side resident continue gasping and started seizing again. All safety measures in place. At 10:50 am, 911 staff arrived provided and took resident to the hospital.
52 2021-04-19 pain in extremity Fever 100.5 - 102.00 4/16, 4/17, 4/18, Fatigue, body pain, nausea, headache 4/16, 4/17,4/18. Fatigu... Read more
Fever 100.5 - 102.00 4/16, 4/17, 4/18, Fatigue, body pain, nausea, headache 4/16, 4/17,4/18. Fatigue, body pain, nausea, facial / eye swelling, pain when walking in lower back and hamstrings 4/19, 4/20
52 2021-04-19 tingling, face paralysis left sided facial tingling and facial weakness
52 2021-04-20 feeling cold Low grade fever, chills, muscle aches
52 2021-04-20 muscle spasms Increased pain and stiffness of cervical spine about 1 week following 2nd vaccine. Progressed to mu... Read more
Increased pain and stiffness of cervical spine about 1 week following 2nd vaccine. Progressed to muscle spasms and/or contacted muscles, up back of neck, into back of head, causing headaches up the back of head. Tinnitus set in around April 7th, and continues. Nausea started on 4/12/21, and continues
52 2021-04-20 pain in extremity Sore arm and a just a little bit tired after both doses of vaccine. However, after the second dose ... Read more
Sore arm and a just a little bit tired after both doses of vaccine. However, after the second dose the volume of my tinnitus increased that evening and is still at the increased level 1 week later. Contacted ENT office, no treatments available.
52 2021-04-20 pain in extremity Sore arm and fever the night after receiving the shot. Light headed 101° fever Chills
52 2021-04-20 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA - 1st day severe arm pain on left side - Took 800 Mg Ibuprofren... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - 1st day severe arm pain on left side - Took 800 Mg Ibuprofren. 2nd day - severe chills, trouble breathing, intense dry heaves, could not keep down water without vomiting, intense muscle pain, intense fatigue, fever. Took 250 mg of tylenol later in the evening after able to hold down water. Left side of body still sore and face swelling on left side. 3rd day - nausea, severe headache - took 250 mg Tylenol and 800 Mg Ibuprofren throughout day with no relief. Still have pain and swelling on left side of face. Injection site is bruised with redness around and very sensitive to touch. Today (Day 4) - still have headache, face swelling on left side, fever blisters on lower lip, nausea, left side soreness and left arm still sore.
52 2021-04-21 facial pain, pain in extremity On Saturday, April 3rd I got my first Pfizer Covid shot. I didn?t have any side effects like what th... Read more
On Saturday, April 3rd I got my first Pfizer Covid shot. I didn?t have any side effects like what they said could happen such as Covid symptoms. On Tuesday, April 13th, 10 days after I had gotten the shot I noticed these red marks by my eye, it was in the morning and they came out suddenly so I thought I had gotten bit by some thing. Over those previous 10 days I noticed that my hands were extremely sore but I have arthritis in my fingers and can have tightening and soreness when the weathers bad so I chalked it up to that. Even though it was worse than what it normally would be. By Friday the 16th, the reddened areas of my face were swollen, my lymph nodes in my neck and around my ear started to swell. My cheek bone,in jaw bone, and eye socket were in terrible pain. I went to medical and they thought it was a spider bite that was getting infected they put me on an anabiotic. I have pictures. Saturday the 17th I was so exhausted! I could not get off the couch. I slept all day Saturday, literally getting up to take a couple of bites of food and either laying back on the couch are going back to bed. Sunday I woke up I felt better not 100% but I had some energy. The marks on my face were no different and now they are getting more painful burning, itching, still swollen and very painful to the touch. 4/20/21 nothing has gotten better. I went to the urgent care one of the PAs said it looks like it?s shingles.
52 2021-04-21 feeling hot As soon as fluid was injected- a wave of heat flowed thru my blood from head to toe. Then came heart... Read more
As soon as fluid was injected- a wave of heat flowed thru my blood from head to toe. Then came heart palpitations, shortness of breath, sweating, and feeling of faint (NO fainting occured). Feelings in head of disorientation/ disconnect. Sent to observation room to lay down. Provided with water- was able to drink it/ no tongue swelling or throat closing. Monitored by paramedic for 1 hour. Before release, oxygen was 100%/ pulse 74%.
52 2021-04-21 pain in extremity, sciatica Body ache, horrible head ache, sciatic and leg pain
52 2021-04-21 pain in extremity Sore arm shortly after administration. Soreness continued into evening and developed headache withi... Read more
Sore arm shortly after administration. Soreness continued into evening and developed headache within a few hours. Sleeping was uncomfortable due to sore arm and restlessness. Next day very sore, headachy and tired. Stayed home from work and slept a lot. Headache and sore arm subsided within a 3-4 days. Next days following some minor headaches and tiredness.
52 2021-04-21 pain in extremity Started to have body aches and return of arm soreness on 4/5 (eight days after the vaccine) Left fla... Read more
Started to have body aches and return of arm soreness on 4/5 (eight days after the vaccine) Left flank intermittent pain, eventually traveling to the left back on 4/9 (interrupted sleep) 4/10 Continued pain, intensifying but manageable with Naproxen (assumed it was a kidney stone) Pain moved to right back and flank on 4/11, supplement NSAID with Tylenol to control the pain but pain grows severe (message PCP) 4/12 See PCP in afternoon, elevated heart rate + pain, suspects kidney stone, suggests ER for quicker CT scan, but ER is a 5+ hour wait, so I scheduled appt. with urologist for 4/13. Get CT scan for stone, lungs present with ground glass opacities like Covid. 4/14 Covid test (plus my partner is Partner is also tested. Isolate at home awaiting results. Pain is now only on the right side, experiencing shortness of breath, assume it's related to the pain. 4/15 get negative Covid results around midnight, message PCP. 4/16 PCP insists on ER, CT scan with contrast reveals pulmonary embolism, clots ib both lungs, admitted to hospital for observation, ultrasound of legs reveals no problems with the veins, etc. Start Lovenox 4/17 released that evening with Xarelto, follow up with doctor 4/22
52 2021-04-22 breast pain Began a very heavy and unexpected bleeding period with cramping and sore breasts 2 days after shot. ... Read more
Began a very heavy and unexpected bleeding period with cramping and sore breasts 2 days after shot. I haven't had a period in 6 months. Far heavier than historic cycles beginning at age 13.
52 2021-04-22 feeling cold Vomited, nauseated, dizzy, shortness of breath, cold, drop in BP 99/70. Laid patient down, took BP, ... Read more
Vomited, nauseated, dizzy, shortness of breath, cold, drop in BP 99/70. Laid patient down, took BP, wait 5 minutes, gave water and called ambulance.
52 2021-04-22 flushing After approx 30 min pt Began getting flushed face and neck. Proceeded to ER began getting swollen es... Read more
After approx 30 min pt Began getting flushed face and neck. Proceeded to ER began getting swollen esophagus. Treated with diphenhydramine and released.
52 2021-04-22 flushing Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of ... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Symptoms began 30min after dose. pt was on way home from vaccine then went to ER for treatment. was given benadryl at hospital then released.
52 2021-04-22 numbness, tremor 4:23 PM Pt began to complain of neck stiffness and nausea. She was brought back to exam room and bec... Read more
4:23 PM Pt began to complain of neck stiffness and nausea. She was brought back to exam room and became increasingly lethargic with complaints of chest pressure, numbness in both arms and tongue swelling. She was placed in supine position and 1ml of epinephrine was administered IM in left thigh. She had a visible rash on her left upper arm, chin, neck and ears. One minute after administering Epinephrine the pt reported feeling better. 4:30 PM the redness was improving and the pt was talking 5:00 PM She began to have shaking in her jaw and left hand and arm. This resolved approximately 10 minutes later without intervention and vital signs remained stable, except heart rate increasing into the low 100's. 5:13 1 ml of Dexamethasone 10mg/ml was given IM in right deltoid. Patient was monitored until 6:15pm and released to return home.
52 2021-04-22 pain in extremity, numbness Jaw, lips, mouth area - numb for 45 hours. Pain under right rib for 18 hours. Severe pain in left ... Read more
Jaw, lips, mouth area - numb for 45 hours. Pain under right rib for 18 hours. Severe pain in left arm & hand with a band across my lower back that came on with the arm/hand pain - hand/arm pain lasted 18 hours with the lower back taking 5 days to subside. Severe head to toe itching - no rash found anywhere- took Benadryl evening of the shot and itching was alleviated. Severe headache just at the forehead and up with extreme dizziness - lasted 33 hours. Fatigue lasted 5 days - severe the first 33 hours.
52 2021-04-22 pain in extremity, tremor Fatigue starting 13 hours post-injection, at 22 hours fever, chills, body aches, severe left arm pai... Read more
Fatigue starting 13 hours post-injection, at 22 hours fever, chills, body aches, severe left arm pain, back pain, headache, uncontrollable shakes. Fever at 102 degrees for 6 hours despite 2 ibuprofen every 3 1/2 hours. Symptoms abated by 36 hours except fatigue- still ongoing at 43 hours post-injection
52 2021-04-22 pain in extremity The back of my left leg hurting all of a sudden on 04/15/2021. The pain on the leg is getting worse... Read more
The back of my left leg hurting all of a sudden on 04/15/2021. The pain on the leg is getting worse each day. Went to the ER on 04/20/2021. Per the doctor no swelling and no redness. I said something is really wrong please check. They did blood work and everything came back good. They did a sonogram and that's where they saw a Blood Clot. Was given Eliquis.
52 2021-04-23 weakness, difficulty speaking mild flu like symptoms; bloody nose; blood sugars were also elevated; severe pain in her stomach and... Read more
mild flu like symptoms; bloody nose; blood sugars were also elevated; severe pain in her stomach and head; severe pain in her stomach and head; tongue was throbbing and hurt; throat was hoarse; when she was talking she would get out of breath really quickly; producing a lot of phlegm/cough; vaginal mucous; eyes also feels like a film is over them; gums began to hurt; weakness/body felt heavy; total exhaustion; Fatigue; This is a spontaneous report from a contactable consumer or other non-HCP via medical information team. A 52-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262) intramuscularly at a dose of 0.3 ml in left arm on 29Jan2021 as single dose for COVID-19 immunization. Patients age at the time of vaccination was 52-years-old. Medical history included type 1 diabetes mellitus, menopause from an unknown date. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, trazodone taken for an unspecified indication. On 30Jan2021, the patient experienced bloody nose; on 31Jan2021, the patient experienced mild flu like symptoms; on an unspecified date the patient experienced blood sugars were also elevated, severe pain in her stomach and head, tongue was throbbing and hurt, throat was hoarse, cough, when she was talking she would get out of breath really quickly (dyspnea), states she slept for several days, producing a lot of phlegm, vaginal mucous, eyes also feels like a film is over them, gums began to hurt, weakness/body felt heavy, fatigue, total exhaustion. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The outcome of the events stomach and head, gums began to hurt, weakness/body felt heavy, fatigue was recovered and total exhaustion was not recovered while for others was unknown. The patient would like to know the timing of the second dose of the Pfizer COVID vaccine if she does not receive it at the recommended 21-day interval. Follow-up (10Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported about the patients height and weight. The patient had a very severe reaction and is still very ill and weak. The patient did have Covid test two days ago and it was negative. No further follow-up attempts are possible, no information is required.
52 2021-04-23 weakness headache; fever; chills; muscle soreness; weakness; This is a spontaneous report from a contactable ... Read more
headache; fever; chills; muscle soreness; weakness; This is a spontaneous report from a contactable nurse (patient) response for herself in HCP letter sent. A 52-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9261, Expiry date: May2021) via intramuscular route in right arm on 26Jan2021 at 11:30 as single dose for covid-19 immunization. Family medical history included all 4 household family members positive covid 18Dec2020 to 20Dec2020. The patients ,medical history included positive covid test. Historical vaccine included dose 1 of BNT162B2 (COMIRNATY) vaccine. On 26Jan2021 at 22:00 (approximately 11 hours after vaccination), the patient experienced headache, fever, chills, muscle soreness, weakness. The patient did not receive any treatment for the events. The adverse events did not require a visit to emergency room or physicians office. The clinical outcome of the events headache, fever, chills, muscle soreness, weakness was recovered. The patient reported that there was a causal relationship between the events and the suspect.
52 2021-04-23 numbness Numbness to arm that was vaccinated. VS WNLs, symptoms improved after 30 minutes and pt cleared by ... Read more
Numbness to arm that was vaccinated. VS WNLs, symptoms improved after 30 minutes and pt cleared by medical provider.
52 2021-04-23 pain in extremity All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the e... Read more
All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; vaccine site started being sore; This is a spontaneous report from a contactable consumer/ Non-HCP (patient). This 52-year-old non-pregnant female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in the left arm, on 12Feb2021at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. Patient's medical history included hypothyroidism, irritable bowel syndrome, primary hypertension, seasonal affective depression and flu. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in left arm on 22Jan2021 at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. The patient had no allergies with medications, food or other products. Concomitant medications in two weeks included levothyroxine sodium(thyroxine), sertraline, hyoscyamine and lisinopril. On 12Feb2021, the patient was a little sore that day, but not the next, vaccine site started being sore. On 14Feb2021 patient spent an hour shoveling snow in the morning, but wasn't sore afterwards. On 14Feb2021 (8 plus hours after shoveling snow), the vaccine site started being sore, but the pain was on again/off again. As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm. All of the joints in both arms ached, 600 mg ibuprofen didn't seem to help. On 15Feb2021(Morning), the injection site is a little sore, the joints in her left arm are sore, and, weirdly, her left hip aches. The throbbing pain last night wasn't like any over-used muscle soreness I've ever experienced and the joint aching was also unlike anything I've experienced outside of when I've had the flu. Patient did not receive other vaccines within 4 weeks or prior vaccination. No COVID-19 prior the vaccination and no COVID-19 test was done post vaccination. Patient's treatment medication included ibuprofen. Outcome of the events were recovering. Information on the lot/batch number has been requested.
52 2021-04-23 pain in extremity Pretty immediate after 1st shot in left arm experienced sharp back / shoulder pain. This continued ... Read more
Pretty immediate after 1st shot in left arm experienced sharp back / shoulder pain. This continued a few weeks , until my second dose. At that time I chose to get 2nd shot in right arm unaware the 1st shot caused an issue. Within 1 week after I was diagnosed with Parsonage Turner Syndrome. Very painful in BOTH ARMS.
52 2021-04-23 pain in extremity Fever, Fatigue, muscle aches, severe headache and are sore at injection site. Injection was given in... Read more
Fever, Fatigue, muscle aches, severe headache and are sore at injection site. Injection was given in left arm and my arm had pain from the neck all down to my fingers.
52 2021-04-23 pain in extremity Had hart pain, chest pain, pain on back where hart is, left shoulders and left hand pain . The pain... Read more
Had hart pain, chest pain, pain on back where hart is, left shoulders and left hand pain . The pain was for 4-5 hours. Had to go to bed. Had to take nitroglycerin.
52 2021-04-23 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
52 2021-04-24 weakness, migraine severe sinus issues; she is still not feeling good; flu-like symptoms; head is foggy right now, cant... Read more
severe sinus issues; she is still not feeling good; flu-like symptoms; head is foggy right now, cant remember her doctors name; sick/ended up really ill yesterday; vomiting; forgetfulness/cant remember her doctors name; Tired; Sore throat; body aches/body aches and pains; chills without fever; severe diarrhea; nausea; She was not able to eat yesterday as well; she mentioned that she still has a bad lack of energy/stayed in bed all day; burning lungs; severe migraine due to her bad sinuses/migraine headache; severe migraine due to her bad sinuses; crusty eyes; Arm was sore where she got the shot for a few days after the Vaccine; This is a spontaneous report from a contactable consumer reported for herself. This 52-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727), via an unspecified route of administration in the upper muscle of left arm on 29Mar2021 at single dose for COVID-19 immunization. Medical history included ongoing heavy smoker smoking for at 32 years or more, not drink anymore, agoraphobia started when COVID pandemic came a year ago, pneumonia, anxiety, severe depression, bipolar, panic attacks due to trauma, on disability since her mother passed away 6 years ago. Her family was alcoholic and her dad was an alcoholic, it was just something she did. She went on a 6 year drinking binge over 10 years ago, but she has been sober for 10 years. The patient had pneumonia, anxiety, severe depression, bipolar, panic attacks For years and believed these were related to abuse from years ago. The patient also believed panic attacks was related to her mother passing and her nephew having a car accident in Oct2020. Concomitant medications included gabapentin (NEURONTIN, NDC: 16714033202) from an unspecified date and ongoing for about 32 years for anxiety; lurasidone hydrochloride (LATUDA) from at least 2 months ago and ongoing for depression; vilazodone hydrochloride (VIIBRYD) ongoing for 5 years to help her sleep and for depression and bipolar; clonazepam from an unspecified date and ongoing for anxiety and panic attack, being on it off and on for 32 years for panic attacks and anxiety; valproate semisodium (DEPAKOTE ER, NDC: 16714048502) from an unspecified date and ongoing for about 5 years for bipolar; escitalopram oxalate (LEXAPRO), benzatropine mesilate (BENZOTROPINE), benzatropine mesilate (COGENTIN); clonazepam (KLONOPIN) ongoing for anxiety and panic attack, being on and off for 32 years; a lot of Psychiatric drugs. The patient to change her antidepressant a lot because if being on it for so long it stopped working. The patient had the Pneumonia Vaccine about 1 year ago and flu vaccine about a year ago not at the same time. She reported not having any problems with that. The patient reported tetanus shot years ago and she got a sore arm. The patient had no prior vaccinations (within 4 weeks). The patient mentioned that she received her 1st dose of the Pfizer COVID19 Vaccine on 29Mar2021. She ended up really ill yesterday on 04Apr2021 at 2: 00 am, with body aches and pains, chills without fever, burning lungs, forgetfulness, vomiting, severe migraine due to her bad sinuses, migraine headache which she rarely got, crusty eyes, severe diarrhea and nausea. She was not able to eat yesterday as well on 04Apr2021. As of calling, she mentioned that she still had a bad lack of energy, probably to being sick on 04Apr2021, and a little bit nauseated but not as bad as yesterday on 04Apr2021. The burning lungs, diarrhea, and migraines were gone. She was asking if these were common to appear after this time because the paperwork from her facility stated that most side effects were to be expected with 24 hours. She also mentioned that her boyfriend got his 2nd dose of the Moderna vaccine with no reactions 3 days before she got ill and was asking if she could've gotten it from him. She was COVID-Phobic and took as many precautions as she could. She mentioned that 2 of her friends, experienced side effects on their 2nd dose. She waited the 15 minutes before she left after getting the shot, with no problem. She hoped no one else has to go through this. She was sick yesterday and today, but it was better today than yesterday. The patient was high risk due to heavy smoking, She said that on the 04Apr2021, at 02:00, she woke up with chills with no fever, body aches and pains, a migraine headache which she never got, severe sinus issues, diarrhea, nausea, and stayed in bed all day. She felt bad enough to go the doctor but did not go to the doctor, had really gone out since COVID started but, she did not go due to agoraphobia. From what she had heard from other people the 1st dose did not affect most people, it's the second. She was scared though and did not want to get sick like she did. She wanted to know if it's safe to get the second shot because she didn't want to experience this again. The patient said that she was still not feeling good. At the time of reporting, the patient still felt nauseated and had body aches and her lungs were burning on 04Apr2021 and she was not sure why. She reported these symptoms were not on the sheet she got. They gave her the sheet from the health department. She had heard of reactions within 48 hours and but, it had been week since she got the 1st shot. The patient said that she had bad chills and did not understand how you have chills without a fever. She was not sick like that ever in her life. It was the worst experience. She said that even with the flu bug she was able to function even with throwing up and all of that other stuff. She had never had problems with an immunization before. She wanted to get the second shot. She didn't know how you get a fever with no chills. Caller confirmed her symptoms were flu-like symptoms and are described as the symptoms she gave earlier in the call. She scared of suffocating to death rather than getting the next shot. The patient asked if it was an allergic reaction or a shot reaction she had, she never experienced anything like that. The patient had no problem with the flu like symptoms like the nausea, the vomiting. The only reason she asked was because she was afraid. She had been house bound for about a year and she only went to the physician and psychiatrist. She was able to go to the health department and get the shot because she did not want COVID. The patient reported her head was foggy right now, can't remember her doctors name because she was still sick. This started after getting the shot along with the flu-like stuff. She can't even remember her doctors information because of how bad she felt. She said that she can't believe that she cannot remember the name of her doctor's office, that was how bad she felt. The patient clarified that the fogginess started after she received the vaccine. She reported she had had severe panic attacks for years due to abuse. Even though she was with a good man now she still had panic attacks and the COVID did not help. She tried sleeping as much as possible last night. The flu-like symptoms started at 0200 in the morning, all her symptoms on 04Apr2021. The fogginess, body aches, diarrhea, pain were still here today, but no headache today 05Apr2021. Her chills were keeping her up yesterday, she had never had chills with no fever before. She had no chills today 05Apr2021, they were gone its 70 degrees here, it was bad. Her burning lungs were gone when she woke up this morning she didn't feel it. If it would have gotten worse she would have went to the ER, but she was able to breath. She was able to take her meds again today 05Apr2021. 1st day in years she did not smoke was yesterday on 04Apr2021. The COVID vaccine gave her a sore arm were she got the vaccine but it only lasted a few days after the shot. About an hour after she got the shot, it lasted a few days and was not bad enough for Tylenol of Motrin it was just a slight ache. She did not seek treatment for the flu-like symptoms but, would have went to ER if burning lungs got worse to where she could not breathe. The patient said that she forgot numbers because of the medications she on and also got the shakes. She was not sure which medications are causing it, but she thought she was taking Depakote, Klonopin and Neurontin could be the cause. The shaking was irreversible, she can't even write her name without shaking. The patient stated yesterday she was so sick, she ended up with like her lungs were burning, body ache, she had chills with no fever, mild sore throat, headache won't go away and she was wondering if that's normal. The patient had to get her second Covid shot 17th and she was so scared, she was sick and tired. Outcome of the events 'head is foggy right now, cant remember her doctors name', 'body aches', 'diarrhea', 'body aches/body aches and pains', 'sick/ended up really ill yesterday' was not recovered, of the event 'Arm was sore where she got the shot for a few days after the vaccine' was recovered, of the other events was unknown. No follow up attempts are needed. No further information is expected.
52 2021-04-24 weakness Bad headache, fever (100.1F), body aches, weakness Rested and took Ibuprofen/Tylenol for symptoms
52 2021-04-24 discomfort the morning after i got the shot i woke up feeling paralyzed like my body weighed 1000 lbs. i could ... Read more
the morning after i got the shot i woke up feeling paralyzed like my body weighed 1000 lbs. i could move but it was very hard. whole body aches..horrible headaches nauseated
52 2021-04-24 flushing lump on wrist; extreme fatigue; hives; flushing of face from neck up from Pfizer COVID vaccine; This... Read more
lump on wrist; extreme fatigue; hives; flushing of face from neck up from Pfizer COVID vaccine; This is a spontaneous report received from a contactable consumer. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 14:15 (Batch/Lot Number: EN6207; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. Medical history included ongoing psoriasis, diagnosed 5 or more years ago, patient stated she has never been checked for psoriatic arthritis, but she has joint pain, ongoing gastrooesophageal reflux disease, ongoing epstein barr virus positive mucocutaneous ulcer, Severe allergies, atrial fibrillation, cerebrovascular accident. Concomitant medications included apremilast (OTEZLA) taken for psoriasis, start and stop date were not reported; lansoprazole (PREVACID) taken for an unspecified indication, start and stop date were not reported. The patient previously took flu vaccine VII, got really sick, never took it again got all the flu symptoms. Caller reports she had flushing and then hives that night and then extreme fatigue. Caller reports noticing a lump on left wrist on 25Mar2021. Lump was red and purplish, caller reports rubbing the lump and the lump ended up moving. Caller reports it was painful. Caller went to the doctor 07Apr2021 and diagnosed with thrombosis of left ulnar artery. Caller states that she knows there not a lot of data out of there. Caller mentioned she has psoriasis and takes Otezla. Therefore, she is autoimmune compromised. Caller went today 08Apr2021 for follow up appointment and the doctor said to report her symptoms to Pfizer because she is immunocompromised and immunocompromised people were not part of the original clinical trials. The extreme fatigue reminded her of Epstein- Barr. Otezla-stopped the day of the first shot. She started it back up a week and half later. Flushing started 4 or 5 hours after dose around 6:15 or 7:15 PM on the top of face from neck up. Caller reports that she had the same thing from a cortisone shot. Hives started 8 hours after first shot around 10:15 PM hives developed on the bottom of both arms from the elbow down on both arms. Caller states that it was very strange. Caller states that she woke up in the night with the itching. Caller states that the hives were gone in the morning. Caller states that extreme fatigue occurred 23Mar2021 and it was hard to even open her eyes. Patient went to emergency room for ultrasound only. Patient visited physician office for event lump wrist. Outcome of event lump on wrist was not recovered, of others was unknown. No follow-up attempts are needed. No further information is expected
52 2021-04-24 muscle spasms Headache; woke up at 2am with headache due to muscle spasm in left neck and shoulder; woke up at 2 a... Read more
Headache; woke up at 2am with headache due to muscle spasm in left neck and shoulder; woke up at 2 am; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 02Apr2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included migraines and allergy to latex, PCN, neomyocin. Concomitant medications included gabapentin, omeprazole, melatonin and cetirizine hydrochloride (ZYRTEC ALLERGY), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included 1st dose of BNT162B2 (Lot/Batch No: EL3247) on 12Mar2021 in arm left for COVID-19 immunisation. Patient woke up at 2 am with headache due to muscle spasm in left neck and shoulder on 03Apr2021. Patient received 2 DF paracetamol (TYLENOL), 2 DF ibuprofen (ADVIL) (4am) and icyhot for headache, muscle spasm in left neck and shoulder. Outcome of the events was resolved. No follow-up attempts are needed. No further information is expected.
52 2021-04-24 pain in extremity Leg pain. Started in calf. Moved to hamstring. Moved to glutes; Leg pain. Started in calf. Moved to ... Read more
Leg pain. Started in calf. Moved to hamstring. Moved to glutes; Leg pain. Started in calf. Moved to hamstring. Moved to glutes; Leg pain. Started in calf. Moved to hamstring. Moved to glutes; This is a spontaneous report received from a Non-contactable consumer (Patient). This 52-year-old female (non-pregnant) consumer reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP7533) via an unspecified route of administration into the left arm on 07Apr2021 09:30 AM (at the age of 52-year-old) at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included allergies to medications, food, or other products. Others included EGPA, asthma, bronchiectasis, vasculitis, eosinophilic granulomatosis with polyangiitis, aspirin [acetylsalicylic acid], iodine and antibiotics all for drug hypersensitivity. The patient concomitant medications included medications that the patient received within two weeks of vaccination which included mepolizumab (NUCALA), prednisolone acetate (PRED+), cetirizine hydrochloride (ZYRTEC ALLERGY), atorvastatin (LIPITOR [ATORVASTATIN]), diltiazem (CARDIZEM [DILTIAZEM]), budesonide, formoterol fumarate (SYMBICORT). On 08Apr2021 05:00 PM, the patient reported of leg pain which started in calf, moved to hamstring and moved to glutes. The patient did not receive treatment nor any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering for all the events. No follow-up attempts are possible. No further information is expected
52 2021-04-24 pain in extremity had pain and soreness in the arm which has subsided now; There's a bump which is extremely sensitive... Read more
had pain and soreness in the arm which has subsided now; There's a bump which is extremely sensitive and is swollen; her hands had gotten puffy; injection site soreness in her left arm; pain in between my knuckles on both hands; This is a spontaneous report from a contactable consumer or other non-HCP. A 52-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER8729), via intramuscular route of administration, in left arm on 10Apr2021 04:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had vaccination on Saturday at 4:30 and probably about 3 hours afterwards, patient noticed her hands had gotten puffy on 10Apr2021. However, patient had pain between the knuckles of both her hands on 10Apr2021. On the left hand, right where the wrist bends, there was kind of like a bump there that is very tender and up to the pointer finger, that knuckle is very tender (of her left hand). There was a bump which is extremely sensitive and is swollen on an unspecified date. On 10Apr2021(maybe 2 hours afterwards), the patient had injection site soreness in her left arm, after four hours her arm became noticeably sore. The patient woke up this morning and had pain and soreness in the arm had subsided greatly on an unspecified date, the soreness is almost gone. The pain with the bending of her wrist and the knuckle joint to her pointer finger on the left hand was staying the same. On 11 Apr 2021(yesterday), this pain came on noticed. She mentions she had not even taken her vitamins that day, she made sure she nothing prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of event pain and soreness in the arm which has subsided now recovered on an unspecified date in 2021, outcome of pain in between my knuckles on both hands and her hands had gotten puffy was not recovered, outcome of there's a bump which is extremely sensitive and is swollen was unknown whereas outcome of site soreness in her left arm was recovering.
52 2021-04-24 unresponsive to stimuli Patient woke the morning after vaccine with a headache and then had an episode where she was unrespo... Read more
Patient woke the morning after vaccine with a headache and then had an episode where she was unresponsive, while her eyes were open she was humming and moaning and husband shaking her no response, episode lasted about 1-1,5 min , patient was tired after episode and went to sleep and did recall what had happened. everything was back to normal at visit 4/6/2021
52 2021-04-25 feeling cold, tremor Within 10 minutes of vaccination, client began having a metallic taste in her mouth, then states she... Read more
Within 10 minutes of vaccination, client began having a metallic taste in her mouth, then states she "wasn't feeling right." Client advanced to dizziness and acute onset of fatigue to the point of almost lethargic, started to complain of pain in back, radiating to from of chest and "feeling cold" with shaking all over.
52 2021-04-25 migraine 4 days after shot blood glucose elevated up to 400 and higher. Memories decreased.. at first thought... Read more
4 days after shot blood glucose elevated up to 400 and higher. Memories decreased.. at first thought maybe I forgot to give my injection. Had a friend help me with it. No, nothing ,I was doing. Had forgotten I had The vaccine until my friend told me we had it together . Then was told needed to report issues, just Incase. Increase memory loss and elevated Blood sugar. Returning on migraines .
52 2021-04-25 pain in extremity, tingling, numbness, muscle spasms 1) within 10 minutes of injection - face above nose became tingly and tight - similar to a botox inj... Read more
1) within 10 minutes of injection - face above nose became tingly and tight - similar to a botox injection - this persisted for the rest of the day 2) Within 10 minutes of injection - dizziness (mild, could still drive) 3) Sore arm at injection site on Day 1 - mild, no redness or swelling 4) Within 1 hour of injection two toes of my left foot became too painful to walk on, but did not hurt when off my feet - lasted until evening, then gone 5)Within 1 hour of injection left leg had muscle aches and cramping 6) Within a few hours had a strange taste in my mouth (like a chemical) - same with smell. Lasted until bedtime - gone next day. Day 2 Mild sore arm at injection site, but remainder of arm 'tingly' Left foot tingly (but toes not hurting) Nose goes completely numb - just the nose. Headache began - mild - alleviated, but not eliminated, with 800 mg IBuprofen Moderate Nausea began with gagging (but not vomiting) Moderate lower back pain - could not move without ibuprofen - ended by nighttime and did not return Dark Urine - cleary dehydrating Dizziness became vertigo by noon second day. Day 3) Arm nearly normal Muscle aches gone Diarrhea began by 10 am Nausea returned - moderate, gagging no vomiting Headache worsened with extreme vertigo by noon Face tightens again - like wearing a tight scuba mask. First temperature - 101.0 800mg Ibuprofen helped overall feeling of illness, but headache not fully eliminated (better but not gone) Sleeping going fine. Day 4 Fine upon waking - no pains Headache and Vertigo return by 10 am, both debilitating Moderate Nausea returns Diarrhea returns Fever less - 100.0 Overall feels like a very bad migraine with nausea and GI trouble, slight fever, and face muscles still intermittently 'tight'.
52 2021-04-25 pain in extremity massive red sores, about quarter size, raised, all over her head. Started the same day. She still h... Read more
massive red sores, about quarter size, raised, all over her head. Started the same day. She still have them, they are scabbed over almost gone, but still has them. Client cannot walk/stand on her feet d/t pain on the soles of her feet, still cannot walk on them.
52 2021-04-25 tingling, numbness Immediately after vaccine patient reported an onset of numbness/tingling in left arm. Patient had d... Read more
Immediately after vaccine patient reported an onset of numbness/tingling in left arm. Patient had decreased sensation to deep touch. Patient reported no issues with 1st vaccine dose. Patient's BP was 136/68 with a pulse of 68. Upon further discussion with patient, she described having been in a coma for approximately 6 months at age 11 or 12. During the coma, patient suffered a stroke and has had had numbness that comes or goes in her left arm or right leg. The numbness lasts for approximately 24-36 hours at a time. Patient is being transported with clinical observer via shuttle to the ED for further evaluation.
52 2021-04-25 tingling Shortly after COVID vaccine #1 patient developed right sided tinnitus that progressed to bilateral. ... Read more
Shortly after COVID vaccine #1 patient developed right sided tinnitus that progressed to bilateral. Later that evening she developed right facial tingling. The next day she developed right arm, leg and scalp tingling with mild. No change in mental status. 1 week later all symptoms resolved except bilateral tinnitus persists.
52 2021-04-25 tremor Fairly sudden extreme chills and shaking
52 2021-04-26 weakness, feeling hot Extreme headache (worst I've ever experienced), extreme body-ache, nausea, high temperature (100.6 d... Read more
Extreme headache (worst I've ever experienced), extreme body-ache, nausea, high temperature (100.6 deg), skin felt like on-fire but was unable to sweat. This lasted about 10 hours (by evening I was feeling alot better after taking Ibuprofen). This was followed by 2 days of low energy and upset digestive system. I have had flu before but the pain I was in was so much worse than that, horrendous.
52 2021-04-26 breast pain Severe body ache, itching rash, armpit swelling, breast pain, muscle pain, fever, chills, bone and j... Read more
Severe body ache, itching rash, armpit swelling, breast pain, muscle pain, fever, chills, bone and joint pain.
52 2021-04-26 burning sensation PATIENT COMPLAINED OF BURNING RADIATING FROM INJECTION SITE TO FINGERTIPS IMMEDIATELY AFTER INJECTIO... Read more
PATIENT COMPLAINED OF BURNING RADIATING FROM INJECTION SITE TO FINGERTIPS IMMEDIATELY AFTER INJECTION. I ADMINISTERED DIPHENHYDRAMINE 50 MG INTRAMUSCULAR INTO THE RIGHT DELTOID. I OBSERVED PATIENT FOR 20 MINUTES AFTER DIPHENHYDRAMINE ADMINISTRATION. SHE REPORTED RESOLUTION OF SYMPTOMS AFTER 20 MINUTES OF OBSERVATION.
52 2021-04-26 feeling hot Mild ache, slight warmth, itchy rash.
52 2021-04-26 feeling hot Redness and Hives from hand to elbow of right arm of the injection site / feeling hot on right sid... Read more
Redness and Hives from hand to elbow of right arm of the injection site / feeling hot on right side of body / infection on back from a cyst that was removed 2yrs prior / severe itchiness at arm and back
52 2021-04-26 feeling of body temperature change Over 04/24/2021 and 04/25/2021, c/o chills, goosebumps, headache, fatigue, intermittent hot and cold... Read more
Over 04/24/2021 and 04/25/2021, c/o chills, goosebumps, headache, fatigue, intermittent hot and cold. 04/26/2021, symptoms previously resolved, but noted redness of approximately 4 inches round vaccination site on right arm. 1 inch dark red circle on outer edge of reddened area. Warm to touch. 04/27/2021, darkened red area over entire site and remains approximately 4 inches round. Continues to remain hard, swollen, warm to touch. Client counseled to contact physician for further recommendations.
52 2021-04-26 flushing 4/15/2021 I received the first Pfizer Covid 19 shot. 4/16/021 woke to find red rash at injection sit... Read more
4/15/2021 I received the first Pfizer Covid 19 shot. 4/16/021 woke to find red rash at injection site. 4/16/2021 at 10:30 am, left arm began to itch at injection site. No additional rash detected. At 6:00PM on 4/16/2021 I began to swell just under my left eye. By 10:00 pm both eyes and forehead had become swollen. Took two Bendadryl thinking that would help. By 8:00 am 4/17/2021 both eyes became nearly swollen shut and swelling had moved to upper lip. Went to ER. ER doctor on call prescribed a steroid shot and oral steroids to take starting the next day. Rx was for (3) 20mg prednisone 1x a day for 4 days. Sunday evening 4/18/2021 still had some swelling in face. Monday, minimal swelling in eye lids. I supplemented Cont'd: I also took Benadryl every 5-6 hours around the clock for four days (from 4/17/2021 - 4/20/2021) which seemed to help minimize the swelling. I also had significant flushing (redness) in my face from 4/17/2021 - 4/21/2021. On Wednesday 4/21/2021 I contacted my General Practitioner for a follow up appointment. During that visit, he said that it would not be good for me to get any further Covid 19 shots. I have canceled my appointment for the second shot. At this time, I have not had any additional side effects but, I will be monitoring over the course of the next several months.
52 2021-04-26 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details:... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: pt had gotten her vaccine and started feeling light headed like she was going to pass out. we got her a fan and a drink. she said she may have had low blood sugar and was nervous about shot
52 2021-04-26 hot flush My hot flashes are not almost unbearable, and I have had heart palpitations daily numerous times thr... Read more
My hot flashes are not almost unbearable, and I have had heart palpitations daily numerous times throughout the day since the vaccine was administered.
52 2021-04-26 pain in extremity, weakness Pfizer dose1 Neck pain, shoulder pain swollen collar bone area, cysts on left , pain in left arm, ex... Read more
Pfizer dose1 Neck pain, shoulder pain swollen collar bone area, cysts on left , pain in left arm, extremely fatigued. Body aches, zeo energy, malaise
52 2021-04-26 pain in extremity Pfizer vaccine. Reactions started the following day. Began with tingling in lips, then tip of tongue... Read more
Pfizer vaccine. Reactions started the following day. Began with tingling in lips, then tip of tongue. Spread to full tongue and then roof of mouth. Lasted 2 days - took Benadryl. Pain under arm started 5 days after vaccine. Large, painful lump under left armpit. Has lasted 2 days - going to primary care doctor next week for care.
52 2021-04-26 seizure PT HAD SEIZURE LASTING <1MIN. SELF RESOLVED. PT BECAME AWAKE AND ALERT. PT REFUSED TX TO HOSPITAL AM... Read more
PT HAD SEIZURE LASTING <1MIN. SELF RESOLVED. PT BECAME AWAKE AND ALERT. PT REFUSED TX TO HOSPITAL AMA
52 2021-04-27 breast pain About 24 hours afterwards I noticed pain in left breast and it is also very swollen. I also have pai... Read more
About 24 hours afterwards I noticed pain in left breast and it is also very swollen. I also have pain from left side of neck down breast/chest to under armpit to back. Please note I have not yet been able to contact my doctor.
52 2021-04-27 facial paralysis, bell's palsy Bells Palsy. Right side of the face paralyzed.
52 2021-04-27 muscle spasms I started my period after 2 full yrs of menopause. Noticeable hormone flux 14 days after first shot,... Read more
I started my period after 2 full yrs of menopause. Noticeable hormone flux 14 days after first shot, just as if I were having a normal cycle, started my period 31 days after first shot, 9 days after my second shot (March 26 1st shot, April 17th 2nd shot, period began April 25th). Strong cramping, heavy flow. An absolutely normal cycle for me, but at least 2 years, nearly 3 years to the day, since my last full period. 4 days in, blood flow and cramps lessening.
52 2021-04-27 pain in extremity Starting at 1:00 a.m. and lasting for approximately 8-9 hours, I had a fever and was sweating; I cou... Read more
Starting at 1:00 a.m. and lasting for approximately 8-9 hours, I had a fever and was sweating; I could not sleep; my right arm was very painful; my entire body ached. It felt like a very bad flu. I took 800 mg of Advil, which helped, and felt well enough to go to work by noon. I had COVID-19 approximately 90 days before my vaccination. I have never had an adverse reaction to a vaccine in my life.
52 2021-04-27 pain in extremity Had small red area that started on 04/24/21 but then on 04/27/21 area became inflamed like a welt an... Read more
Had small red area that started on 04/24/21 but then on 04/27/21 area became inflamed like a welt and doubled in size. By end of day on 04/27/21 area was even more inflamed and itchy. By morning of 04/28/21 area has tripled in size though not itching as of now. Area is also warm to touch and is somewhat painful if pressed on. Area is also no completely circular as it is spreading to about the size in uneven circumference the size of a baseball. I am on daily antihistamines once daily but on 04/27/21 took it a second time. This did take away the itching but has not reduced the size of the rash/redness/swelling.
52 2021-04-27 tingling, cold extremities I noticed that my legs and arms are tingling and cold.
52 2021-04-27 tingling tingling on fingers, pain experienced at injection site, dizziness
52 2021-04-28 inability to speak On the 26th I experienced a TIA (mini-stroke) though I have no risk factors. It was one week after ... Read more
On the 26th I experienced a TIA (mini-stroke) though I have no risk factors. It was one week after my second Pfizer shot. I couldn't see out of my R eye, like bright white light--snow blind, then I couldn't decode the words I was trying to read on my computer email. Then I got up and walked around, made a call and on the call was unable to say the word I wanted to say (Aphasia).
52 2021-04-28 weakness, pain in extremity Low grade temperature. Fatigue, weak. Joint pain. Arm felt tight and painful. Really bad headache.
52 2021-04-28 hot flush, tingling, numbness, numbness and pain in extremities Since the second shot, I have experienced minor hot flashes and numbness/tingling and heightened sen... Read more
Since the second shot, I have experienced minor hot flashes and numbness/tingling and heightened sensitivity to hot and cold on my hands and forearms, nothing debilitating, and could also Be attributed to periomenopause?
52 2021-04-28 numbness TIA; a rush of numbness came over my whole left arm. My arm; My arm was numb, heavy and weak; My arm... Read more
TIA; a rush of numbness came over my whole left arm. My arm; My arm was numb, heavy and weak; My arm was numb, heavy and weak; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208, expiration date not reported), via an unspecified route of administration on 17Mar2021 (at the age of 52-years-old), 8:00am at single dose in the left arm for COVID-19 immunisation. Medical history included hypothyroidism and ADHD (attention deficit hyperactivity disorder). The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) 88mg and lisdexamfetamine mesylate (VYVANSE) 40mg both taken from unknown dates and unknown indication. The patient previously took clarithromycin (MACROBID) and experienced allergies. Historical vaccine included first dose BNT162B2 (brand: Pfizer) received on 24Feb2021 6:00pm (lot number: EN6202) at the age of 52-years-old in the left arm. It was reported that on Thursday, 08Apr2021 at approximately 7:00pm, the patient was standing in her kitchen when all of a sudden, a rush of numbness came over her whole left arm. The patient's arm was numb, heavy, and weak. She knew that this feeling was not normal, so she had her husband take her to the hospital, their local hospital. They arrived at approximately 7:30pm where the patient was took in right away. At that time, the feeling had returned to the patient's arm. The patient was taken back for a CAT scan on her head after which the doctor came to tell her that they would be keeping her overnight for observation since they think she had TIA (transient ischaemic attack). The patient was monitored overnight and at 6am the next day on 09Apr2021, she had an ultrasound on her carotid artery and later in the morning, at around 10am, the patient had an echo cardiogram. The patient was released at approximately 12pm on Friday, 09Apr2021. The events experienced resulted in "Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization from 08Apr2021 to 09Apr2021". The patient has no COVID prior vaccination and had not tested for COVID post vaccination. Outcome of all the events was recovering.
52 2021-04-28 pain in extremity within 15 minutes she developed lingering headache, major body aches, some chills and was light head... Read more
within 15 minutes she developed lingering headache, major body aches, some chills and was light headed. She became very fatigued. Her right arm was swollen and painful. Her symptoms lasted 3 days.
52 2021-04-28 pain in extremity blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremen... Read more
blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremendously; This is a spontaneous report from a contactable Nurse. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 13:45; at the age of 52-years-old, (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing memory impairment (She states that she was diagnosed either last year or the year before that she can't remember. She states that it is ongoing, but it is well controlled). Historical vaccine included vaccine to tetanus (About 3 or 4 years ago). There were no concomitant medications. The patient experienced blood clot (thrombosis) (disability) on 13Apr2021 with outcome of not recovered, swelling and pain in right leg (disability, medically significant) on 09Apr2021 with outcome of not recovered, right arm hurting tremendously (disability) on 01Apr2021 with outcome of recovered on 04Apr2021. The patient underwent lab tests and procedures which included ultrasound scan: positive on 13Apr2021 had a blood clot. Therapeutic measures were taken as a result of blood clot (thrombosis) included Xarelto and due to pain in extremity the patient received ibuprofen (7 ibuprofen every day); Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Thrombosis. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
52 2021-04-28 pain in extremity pt says she developed body aches and pains, dizziness, extreme fatigue, chills. She was lightheaded... Read more
pt says she developed body aches and pains, dizziness, extreme fatigue, chills. She was lightheaded and the fatigue was so bad that she felt like she had been drugged. Her right arm and hand were swollen and painful. There was a large knot around the injection site. The pain and swelling in right arm affected her mobility to work. Large varicose veins appeared on her forehead. These symptoms lasted about 4 days. She is better but says she still get large veins that appear on her forehead from time to time.
52 2021-04-28 tremor, migraine Immediate ( within 1-2 minutes) spike in heart rate and blood pressure, tightness in chest, nausea, ... Read more
Immediate ( within 1-2 minutes) spike in heart rate and blood pressure, tightness in chest, nausea, light headed, shakes. Continued high blood pressure, migraines, ringing in ears continuing on day 6
52 2021-04-28 tremor, tingling, weakness, inability to speak, migraine, numbness Fever, nausea, blinding migraine DEBILITATING fatigue, chills with teeth chatter (5 hours), body sk... Read more
Fever, nausea, blinding migraine DEBILITATING fatigue, chills with teeth chatter (5 hours), body skin hot to touch, severe pain at shoulder cradle and unable to lift Or use arm, leg tremors, torniquet-tight feeling in lower leg right below knee that turned to numbness then pins nd needles, underlying headache every day since first dose, sleeping 12 hours a night although my usual is between 6-7 hours, no energy, have trouble performing most physical tasks, losing words as I'm speaking, forgetting simple I formation such as my son's fiance's name. Moat of these are ongoing
52 2021-04-29 weakness body aches, fatigue, weakness, spontaneous vaginal bleeding, abdominal and pelvic pain
52 2021-04-29 numbness, tingling Patient felt numbness and tingling on the right side of her face, she also reported having a rash be... Read more
Patient felt numbness and tingling on the right side of her face, she also reported having a rash behind her right ear.
52 2021-04-29 pain in extremity Painful arm, swelling, low grade fever, tired, itching
52 2021-04-30 migraine Migraine; Nausea; Vomiting; Muscle Aches; Diarrhea; This is a spontaneous report from a contactable ... Read more
Migraine; Nausea; Vomiting; Muscle Aches; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 17Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had these symptoms including migraine, nausea/vomiting, muscle aches and diarrhea starting 24-72 hours after her injection on Apr2021. The outcome of these events was unknown at the reporting time. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-05-01 weakness Extreme tiredness the day of the vaccination, for about 10 days I experienced weakness and slight ve... Read more
Extreme tiredness the day of the vaccination, for about 10 days I experienced weakness and slight vertigo, along with headaches.
52 2021-05-01 flushing, feeling jittery Approx 7 minutes after injection became flush, rapid heart rate, short of breath. Nurse had me lie o... Read more
Approx 7 minutes after injection became flush, rapid heart rate, short of breath. Nurse had me lie on stretcher and monitor my vitals. My blood pressure was high. After about 15 minutes heart rate and blood pressure came down. I was feeling very jittery for approx 45 minutes.
52 2021-05-02 pain in extremity After a couple of weeks of pain at the injection site, the pain began to grow steadily until today i... Read more
After a couple of weeks of pain at the injection site, the pain began to grow steadily until today it reaches down the top of my right arm, the underside of my right arm, and down my side from my arm pit to below my ribcage. It used to hurt only when I would utilize certain ranges of motion. Now, it hurts on and off regardless of my movements. Sometimes it hurts all the way to my hand. I cannot sleep on my right side anymore and if I accidentally move it in too large of a motion the pain is at a 10.
52 2021-05-02 tingling, feeling cold Within 15 minutes developed throat swelling and chest tightness. Over the next few days developed pa... Read more
Within 15 minutes developed throat swelling and chest tightness. Over the next few days developed paresthesias, cold sensations in extremities.
52 2021-05-02 seizure Reduced immune system, potential. Strep throat infection required 4 antibiotics to resolve. Immediat... Read more
Reduced immune system, potential. Strep throat infection required 4 antibiotics to resolve. Immediately followed by new onset seizures.
52 2021-05-03 burning sensation, feeling hot 0n 4-23-21 I was going to sleep when my arms started burning then my legs, my face and upper chest. ... Read more
0n 4-23-21 I was going to sleep when my arms started burning then my legs, my face and upper chest. I had a rash, swelling and redness that started in my arms to finally my head. It burned like I was on fire and my heart was racing more than usual. I put wet towels on my arms, legs and face. Took benadryl and after 4 hours took zyrtec. It took 4 hours for swelling to go away and the rest of the night for the redness to go away. I have taken either Benadryl or Zyrtec each day as I can feel the urge for the hot itchy stuff wanting to return. On the 27th of April I had another reaction just as described with swollen face. This time I woke up with it. Took additional benadryl with zyrtec. May 2nd had another full body rash with redness and swelling, this one went away quicker once I took benadryl. I elimanated anything new from my diet/supplements when this first happened but quickly there was not anything but my usual every day food and medication that was left to eliminate.
52 2021-05-03 facial paralysis, mild one side paralysis I63.511 - Acute ischemic right MCA stroke R53.1 - Left-sided weakness G51.0 - Facial paralysis on l... Read more
I63.511 - Acute ischemic right MCA stroke R53.1 - Left-sided weakness G51.0 - Facial paralysis on left side I63.9 - Stroke determined by clinical assessment I63.411 - Cerebral infarction due to embolism of right middle cerebral artery
52 2021-05-03 pain in extremity, breast pain Expected arm soreness, fatigue, headache immediately or shortly after vaccination. Unexpected change... Read more
Expected arm soreness, fatigue, headache immediately or shortly after vaccination. Unexpected changes to breasts (swelling and soreness) and menstrual flow 4-14 days following vaccination.
52 2021-05-04 breast pain extreme pain, left side from back to ribs and breast. Went to ER on 5/3/21, had EKG, CAT, ultrasoun... Read more
extreme pain, left side from back to ribs and breast. Went to ER on 5/3/21, had EKG, CAT, ultrasounds, etc. Diagnosis = bi-lateral pulmonary embolism. TX = Eloquis for next 30 days.
52 2021-05-04 numbness, discomfort, speech disorder, feeling hot, feeling of body temperature change allergic reaction; wasn't able to lift her hands; blood pressure was very low at about 80/59; tired;... Read more
allergic reaction; wasn't able to lift her hands; blood pressure was very low at about 80/59; tired; light headedness; Didn't feel very comfortable; weak in the legs; She was warm or cold, hot then suddenly cold; chills; fogginess; fainting reaction 15 minutes after getting the shot; palpitations for an hour; numbness in her lower jaw/bottom jaw was half numb; weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking; weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking; inner side of her leg, calf, and thigh was feeling hot; kind of a tightness in her chest/Every next breath was getting weaker and they disappeared after an hour. She felt like someone was holding her chest, do not let her to deep breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 52-year-old female patient received BNT162B2, dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 08:30 (Batch/Lot Number: ER8729; Expiration Date: 31Jul2021) (at the age of 52-years-old) as single dose for COVID-19 immunisation. She reported says she was getting it because people who were vaccinated are being less cautious and putting her at risk for COVID. The vaccination facility was organized through a pharmacy was not administered in a military facility. Medical history included measles on an unknown date (she was sick only once with measles). The patient reported no family medical history but the only thing to put about her probably was that she has maybe rare in a good way immune system. She thought children infections that kids usually get, some of them are very contagious, she was sick only once with measles. She says she has never had chicken pox, she was not vaccinated for chicken pox, she was in contact with multiple people with chicken pox, has antibodies with chicken pox but she never had symptoms, she was never sick. She said she was never sick with any children's infection, she usually did not get sick at all, no flu, no cold things, never. She was not sure if it was measles or if it was rubella as she was translating from another language. There were no concomitant medications. The patient previously took lidocaine and experienced allergy with symptoms of cold sweat and palpitations. She says this allergy started a very long time ago. She said it was affecting only dental procedures and that they know about so they just don't use it on her. She says they consider it not be the lidocaine but due to the ephedrine inside of the lidocaine. She lists her symptoms as cold sweats and palpitation, no pain. She reported they thought the reaction was just too strong, she had 2 episode in 2 different offices, they don't use it on her. The patient had no prior vaccinations within four weeks. The patient declined being sick at the time of vaccination. On 08Apr2021, the patient experienced fainting reaction 15 minutes after getting the shot , palpitations for an hour, numbness in her lower jaw/bottom jaw was half numb, weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking, inner side of her leg, calf, and thigh was feeling hot; kind of a tightness in her chest/every next breath was getting weaker and they disappeared after an hour. she felt like someone was holding her chest, do not let her to deep breath, not destructions with breathing, tired, lightheadedness, didn't feel very comfortable, weak in the legs, she was warm or cold, hot then suddenly cold, chills, and fogginess. On 14Apr2021, the patient experienced blood pressure was very low at about 80/59, wasn't able to lift her hands, weak again and dizziness. The patient's second dose was supposed to be next Friday but her healthcare provider thought it was an allergic reaction (unspecified date) and advised her to not get the second dose. The patient wanted to know what would Pfizer advise. The patient did not know if it was because of COVID but thought those were the effects of any kind of vaccines. The patient clarified her jaw was only half numb. She reported the events started after 15 minutes, the jaw was later, palpitations started after she broke the pattern of her thinking, that wasn't right. She said we had the list but it was missing that it started with one symptom and was replaced by another symptom. She said the only 2 that were together was the jaw part and the palpitations. She says the jaw part was a very short period of time, she felt it and thought what was this, she did not know how long it was, maybe one minute, less than one minute. She reported her palpitations were periodical palpitations, every next breath was getting weaker and they disappeared after an hour. The patient also reported her legs part was after the palpitations were gone. She had talked to multiple nurses and she realized from telling the story 5 times that the symptoms started from up to the bottom; the reaction was from her head to her legs. She reported that she doesn't feel very comfortable, she doesn't know what will happen to her, no one knows. She says all symptoms were on the same day, she was able to move and felt comfortable to move after an hour and a half. She says she started to move after symptoms in the legs started to disappear, she was not able to take deep breath but she was able to breathe without destructions. She says she felt like someone was holding her chest, do not let her to deep breath, not destructions with breathing. She tries to explain the temperature situation, saying the feeling during this time was warm or cold, hot then suddenly cold, that there was no one explaining what happened with her. She says she she remembers noticing that suddenly she had chills. cold, she was talking to someone and she felt cold, she can't exactly say what. She says this probably lasted half a day, maybe 12 hours: She says she was very dizzy on that day, suddenly, and at night she measure her pressure to see what is going on. She says she she has been known for low blood pressure earlier in her life. She says 110/70 was her normal and she had around 80 something, 86/59, something like that, she hasn't had such a low blood pressure in 30 years, maybe since her pregnancy. She stated that she has recovered completely from everything. She says she is not sure if its coming back, she did not expect to have low blood pressure, but right now she is totally fine, a normal person. The patient confirmed her blood pressure was, she thought 86/59 on 14Apr2021. She said she took her blood pressure 2 times, a couple times, the first time was even lower on 14Apr2021. She says on the actual 08Apr2021 she took her blood pressure and it was 120 over something, a little bit higher than it usually would have been. She said she was usually running towards the lower acceptable range, 110 to 70, 110 to 75, something like at doesn't get more than 113. The events did not require a visit to emergency room nor a visit to physician's office. The patient wanted to know if these side effects were known to Pfizer and what happens to those side effects. She asked do they have information on if they increase with the second vaccine. The outcome of the events fainting reaction 15 minutes after getting the shot, palpitations for an hour, numbness in her lower jaw/bottom jaw was half numb, weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking, inner side of her leg, calf, and thigh was feeling hot; kind of a tightness in her chest/every next breath was getting weaker and they disappeared after an hour. she felt like someone was holding her chest, do not let her to deep breath, not destructions with breathing, tired, lightheadedness, didn't feel very comfortable, weak in the legs, she was warm or cold, hot then suddenly cold, chills, and fogginess was recovered on 08Apr2021; outcome of events weak again, dizziness, wasn't able to lift her hands, blood pressure was low was recovered on 14Apr2021; while outcome of allergic reaction was unknown.
52 2021-05-04 migraine vomiting; pain at injection site; headache/throbbing; migraine; This is a spontaneous report receive... Read more
vomiting; pain at injection site; headache/throbbing; migraine; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in left upper arm on 17Apr2021 at 52 years old at 08:52 (Lot Number: EW0161; Expiration Date: Jul2021) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were none. There was no history of all previous immunization with the Pfizer vaccine considered as suspect, no vaccine was administered within 4 weeks Prior Vaccinations, no events followed prior to vaccination. Patient got connected with you after doing a report for her side effects from the Pfizer Covid 19 vaccine. She was concerned about the second round, if this was considered a severe reaction or normal. She had little pain at injection site and headache at first on 17Apr2021 that turned into a 36 hours migraine with vomiting. Migraine started from 17Apr2021 and Vomiting started from 18Apr2021. Caller stated she had a reaction and was just curious if this was still considered one of the more normal side effects. Caller stated she experienced a migraine that lasted almost 36 hours with vomiting. Caller stated she was a little hesitant to receive the second dose. Caller stated she received the vaccine Saturday 17Apr2021 in the morning and she developed a headache the throughout day and it was throbbing. Caller stated she still had a little bit of a headache when she woke up on Monday but it was much better and reduced down to a mild head-ache. Caller stated she definitely had this all night Saturday, then all day Sunday and most of the night, and then the severity was much less Monday morning where it was manageable. Caller stated the migraine stopped later on Monday (19Apr2021). About treatment, patient stated just before she vomited she took an Advil so she did not know if it was in her system long enough. Caller stated and so later on since she was not sure she took two Advils the equivalent of like an Ibuprofen it was generic. There was no Relevant Tests. The patient had recovered from headache and migraine on 19Apr2021, and recovered from Vomiting on 18Apr2021. Outcome of pain at injection site was unknown. Serious criteria was non-serious. No follow-up attempts are needed. No further information is expected.
52 2021-05-04 muscle twitching Caller stated she had soreness; Really bad allergies for spring and summer with the pollen have gone... Read more
Caller stated she had soreness; Really bad allergies for spring and summer with the pollen have gone away; she started having an eye twitch/Eye Twitching; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 09Apr2021 12:00 (Batch/Lot Number: ER8730) as single dose for COVID-19 immunisation. Medical history included bipolar disorder from 2001 and ongoing, pancreatitis from 2003 and pollen allergy. Family medical history included Alzheimer's and heart disease. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and VITAMIN D NOS (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Caller stated she had two side effects, one good thing and one bad thing, Caller stated she was usually sick this time of year but caller stated her allergies went away specifically mentioning pollen but now there was nothing. She noticed this on 12Apr2021. Caller stated she had soreness but no headache after the vaccine but two days after the vaccine she started having an eye twitch on 10Apr2021. Caller stated it did not last all day and was periodically and lasted for 3-5 minutes. Outcome of allergies went away and eye twitch was not resolved. Outcome of soreness was unknown. No follow-up attempts are needed. No further information is expected.
52 2021-05-04 nerve pain, burning sensation, nerve pain, burning sensation Immediately upon receiving the shot I started to have a headache and pain in my eyes. My eyes became... Read more
Immediately upon receiving the shot I started to have a headache and pain in my eyes. My eyes became light sensitive and I have a heightened ability to smell for the rest of the day. I awoke in the middle of the night with a fever, severe muscle and joint pain, splitting headache, tinnitus, skin sensitivity, neuralgia and a VERY sore vaccine site. My fever persisted for 60 hours and did not exceed 101.99. This morning my nerve pained flared in my jaw, tongue, mouth, throat and rib cage. I felt a very painful burning sensation similar to heartburn. I had a very similar reaction with the first shot except I did not have a fever and the symptoms did not last as long as with the second shot.
52 2021-05-04 pain in extremity Normal symptoms: arm pain for 1 week, fatigue for 2 days Abnormal symptom: cloudy vision for 2 days ... Read more
Normal symptoms: arm pain for 1 week, fatigue for 2 days Abnormal symptom: cloudy vision for 2 days (it's as if I had a film over my eyes)
52 2021-05-04 tingling, pain in extremity pt complaining about arm pain- says too high in shoulder- felt tingling sensation as if she hit funn... Read more
pt complaining about arm pain- says too high in shoulder- felt tingling sensation as if she hit funny bone and states is in too much pain. it was explained that it has not been 24 hours yet, but wants her side effect reported
52 2021-05-05 muscle spasms About 3 hours after getting the second vaccine, I began to experience strong menstrual- like crampin... Read more
About 3 hours after getting the second vaccine, I began to experience strong menstrual- like cramping. I am post-menopausal, so this was unexpected and very noticeable. The cramping was followed by a very loose bowel movement, which was very much like what I would experience with my monthly menstrual cycle years ago. The cramping lasted for the day, and the next morning I felt completely normal. Please note that my first vaccine dose had zero side effects.
52 2021-05-05 pain in extremity Persistent Bilateral leg pain, bilateral muscle stiffness and weakness. Bilateral knee pain, left k... Read more
Persistent Bilateral leg pain, bilateral muscle stiffness and weakness. Bilateral knee pain, left knee worse than right. Bilateral ankle pain.
52 2021-05-05 pain in extremity I have always had "silent" acid reflux but the day of my shot and still today, 3 full days later, my... Read more
I have always had "silent" acid reflux but the day of my shot and still today, 3 full days later, my reflux has been out of control. It is much worse than normal. This is the abnormal side effect I am reporting. I tried to Google it and see if others had this same issue. Very little is mentioned. Just minor heartburn. I also had all of the other typical side effects for the second vaccine. My arm is very sore, swollen, itchy, hot, red. I had 2 days of fatigue, tiredness, extreme body aches, joint pain, headache, nausea, diarrhea.
52 2021-05-06 burning sensation 1 hour afterwards with severe arm burning and bright red spreading rash. Pt went to ED. She had spre... Read more
1 hour afterwards with severe arm burning and bright red spreading rash. Pt went to ED. She had spreading rash to her elbow and was having severe burning. Got vaccine at 3:30 and went to ED by 6:00PM got benadryl and Decadron. 4/21 arm and elbow is still bright red and burning.
52 2021-05-06 difficulty speaking, tremor, tingling, numbness 24 hours later my neck started swelling up, my left lymph node; abnormal mass in my neck which was m... Read more
24 hours later my neck started swelling up, my left lymph node; abnormal mass in my neck which was my lymph node; I developed a headache over the whole left side of my head; I could hardly move my neck; All of a sudden I kind of broke out in the sweat; Left side of my head just went totally numb; Started feeling tingling in my left hand; I went to eat some yoghurt and I could not swallow at all; Airway is being compromised by the swelling in my neck; I cannot walk my left leg is dragging, so I am lurking around having to hold on; My voice was like had to whisper; Right side of my body started shaking; Later that evening the numbness subsided. I could speak better my left lymph node was still sore; blood pressure went up; white blood cells count was really, really extremely high; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 13Apr2021 (Lot Number: EW0153), at the age of 52 years, as single dose for COVID-19 immunization. Medical history included covid-19 in Sep2020. Concomitant medication was not reported. The patient experienced 24 hours later, after vaccination, her neck started swelling up, her left lymph node; abnormal mass in her neck which was her lymph node, which required hospitalization. The patient she developed a headache over the whole left side of her head. She could hardly move her neck. All of a sudden she kind of broke out in the sweat, left side of her head just went totally numb. Started feeling tingling in her left hand. She went to eat some yoghurt and she could not swallow at all, airway was being compromised by the swelling in her neck. She cannot walk her left leg was dragging, so she was lurking around having to hold on. Her voice was like had to whisper. Right side of her body started shaking, Later that evening the numbness subsided. She could speak better, her left lymph node was still sore. Blood pressure went up, white blood cells count was really, really extremely high. The patient was hospitalized from 14Apr2021 to 16Apr2021. The clinical course was reported by the patient as follows: When probed for the reason of hospitalization, consumer stated, "The symptoms I had was, I got the vaccination in my left arm, 24 hours after getting the COVID vaccination shot on 13Apr2021, almost exactly 24 hours later my neck started swelling up, my left lymph node, which I was expecting to have that problem. And I could hardly move my neck and then I developed a headache over the whole left side of my head and behind my eye and it was hurting and then it hurt my ear. So, I was having ear ache too. So, that went on for about an hour and a half and then all of a sudden I kind of broke out in the sweat and the left side of my head just went totally numb and then I started feeling tingling in my left hand and so I went to the bathroom to see if my face was numb, to see if I had any paralysis of my face which I did not have any at all, it was just numb. So, then I am concerned, so I decide I am going to take an Aspirin and so before I took the Aspirin I wanted to eat something because I had not had anything to eat that day. I went to eat some yoghurt and I could not swallow at all, I couldn't swallow the yoghurt. So, then I am concerned my airway is being compromised by the swelling in my neck. So, I got to call # and then I cannot walk my left leg is dragging, so I am lurking around having to hold on and then when I called # my voice was like had to whisper and it was hard to get an information where I was at. Finally they arrived and I was taken into the ambulance and when I was in the ambulance my blood pressure went up and also the right side of my body started shaking, they took me to the hospital. I was in the hospital. I had MRI, a CT scan and all of those things and it was negative for a blood clot or anything, heart problems or brain bleed. So, they ruled all of that out, my white blood cells count was really, really extremely high that is what the doctor said and anyway so I was admitted in the hospital and now I can talk better and the numbness is going away on the 14th a day later which went on for the symptom. So, later that evening the numbness subsided. I could speak better my left lymph node was still sore and everything and of course they did noticed that in the scan, MRI stuff about the abnormal mass in my neck which was my lymph node.". The patient stated, "I was hospitalized on 14Apr2021 and I was released the evening of 16Apr2021. Treatment: the patient stated they did not treat her for anything except for the high blood pressure when out there and that is it. The clinical outcome of Lymph node pain was not recovered. The clinical outcome of the remaining events was unknown.
52 2021-05-06 numbness, tingling 3 days after vaccine, I developed pins and needles/numbing in my arms, hands, legs and feet. I still... Read more
3 days after vaccine, I developed pins and needles/numbing in my arms, hands, legs and feet. I still have it today. I am continuing to go to different doctors and practitioners. Sometimes it gets a little better and then gets worse again.
52 2021-05-06 numbness and pain in extremities neuropathy on her left hand and foot, it never got better/got worse in her left arm and hand; had a ... Read more
neuropathy on her left hand and foot, it never got better/got worse in her left arm and hand; had a knot came up under her arm; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose on an unspecified date (batch/lot number and expiration date were not reported) and second dose on an unspecified date (batch/lot number and expiration date were not reported); both via an unspecified route of administration, administered in the left arm as a single dose for COVID-19 immunization. Relevant medical history indicated that the patient had suffered with neuropathy for years and her vitamin D levels were low; both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After the first dose on an unspecified date, the patient had a knot came up under her arm within the first 24 hours and neuropathy on her left hand and foot; it never got better. She received the second dose and it got worse in her left arm and hand. She also got another knot under her left arm. The events took place after use of the product. The patient was not recovered from the events. Information on the batch/lot number has been requested.
52 2021-05-06 pain in extremity, cold sweat lost consciousness; fever; chills; cold / hot sweat; cold / hot sweat; body aches; diarrhea; vomitin... Read more
lost consciousness; fever; chills; cold / hot sweat; cold / hot sweat; body aches; diarrhea; vomiting; vertigo; fell on the bathroom floor; had a little pain in the arm; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 at 08:15 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Mar2021 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced fever, chills, body aches, left arm pain, and diarrhea. Relevant medical history included COVID-19 infection on an unspecified date, lyme disease, seasonal allergies and penicillin allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm. The events resulted in an emergency room visit, however, the patient did not receive any treatment for these events. The outcome of the events lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm was unknown. Since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : same patient/reporter, different AE/first dose.
52 2021-05-06 pain in extremity within 5 days of vaccine. severe joint pain in toes, ankles. knees, hips, base of spine, upper back,... Read more
within 5 days of vaccine. severe joint pain in toes, ankles. knees, hips, base of spine, upper back, neck, shoulders, elbows, wrists and fingers. pain has worsened. also pain in left leg, burning and soreness just behind the knee still persists
52 2021-05-07 weakness, flushing CLIENT BECAME DIZZY, DIAPHORETC-POST VACCINE 5 MINUTES. ESCORTED TO EXAM ROOM-PRONE WITH LEGS ELEVA... Read more
CLIENT BECAME DIZZY, DIAPHORETC-POST VACCINE 5 MINUTES. ESCORTED TO EXAM ROOM-PRONE WITH LEGS ELEVATED. CONTINUES TO C/O DIZZINESS, FLUSHING AND WEAKNESS. UNABLE TO SIT UPRIGHT WITHOUT INCREASE IN SYMPTOMS. C/O WEAKNESS. RAPID RESPIRATIONS BUT DENIES DIFFICULTY BREATHING. EMS CONTACTED. TRANSPORTED TO HOSPITAL.
52 2021-05-07 numbness, tingling, burning sensation I fainted( the day after 1st dose); When I regained conscious I started to feel numbness and tinglin... Read more
I fainted( the day after 1st dose); When I regained conscious I started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet.; My blood pressure was 89; When I regained conscious I started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet.; pain in joint; I have been feeling burn; This is a spontaneous report from a contactable consumer. A 52-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6204) via an unspecified route of administration, administered on left arm on 19Mar2021 08:45 (Batch/Lot Number: EN6204) and second dose via an unspecified route of administration, administered on left arm on 09Apr2021 09:15 (Lot Number: EP7533) as single dose, for covid-19 immunization. The patient Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient concomitant medications were not reported. On 20Mar2021 02:00 PM, the patient fainted after the 1st dose. Her blood pressure was 89. When she regained conscious, she started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet. Since then, she had been feeling burn and tingling in her hands and feet. Some pain in her joint. The paramedic asked her to walk and then It went away on that moment. The patient underwent lab tests and procedures which included blood pressure measurement was 89. The patient did not receive any treatment for the events. The outcome of the events was reported was recovered /Recovered with lasting effects. Information about Lot/Batch number is obtained. Additional information has been requested
52 2021-05-08 electric shock sensation, migraine, tremor I was alone. I have little memory of the early a.m. hours after the vaccination. I wasn't cold but... Read more
I was alone. I have little memory of the early a.m. hours after the vaccination. I wasn't cold but was trembling so I thought the bones in the roof of my mouth were cracking. It took me hours to get up and get to the kitchen to get tylenol which was impossible with the trembling. I had a 100.8 fever, though the thermometer didn't really stay in my mouth. I was extremely short of breath. All of my nail beds were blue. I honestly don't remember all details of that round of after effects other than that I could barely walk. The next afternoon when I sort of came-to I noted I'd used 22 inhalations on my albuteral inhaler the hours I was in bed, I don't remember using it. I had the zaps all day and the next night. I woke with a migraine early am the next morning to the point of almost vomiting, I've not vomited in 15 years. I don't get migrains but for a few back in my 20's. I had some SOB and headache on and off and dizziness persists. there is more, but my greatest concern is the SOB and clear oxygen issue I had with the blue nail beds. I believe I wasn't thinking nor remembering due to that. Had my adult aged kids been here I suspect they'd have called me an ambulance. I wish they had been as I remember being terrified not being able to get up, but I just kept trying to sleep a bit more. There needs to be a MUCH better check system here for people. Maybe even suggested not to be alone the night after the vaccination (either dose really). I've never seen my nailbeds so blue in my life. I've seen it on a friend once years ago, she was bleeding internally. Headaches continue. Oh and food does not taste right yet. It took 2 days for anything to taste normal, but many things still don't.
52 2021-05-08 pain in extremity Doctor has diagnosed it as inflammatory enthesopathy. I have swelling and pain that comes on sudden... Read more
Doctor has diagnosed it as inflammatory enthesopathy. I have swelling and pain that comes on suddenly and stops in approximately 2 days. It has happened in multiple areas of my body, right hand, right wrist, left shoulder and left hip. I have swelling at not as a significant level in my left wring finger.
52 2021-05-09 muscle spasms 4 year - Post Menopause cramping, bloating, and spotting. Have not had a period since 5/2017. 'Spot... Read more
4 year - Post Menopause cramping, bloating, and spotting. Have not had a period since 5/2017. 'Spotting' 4/29-5/1. Minor cramping off and on 4/29-present. Bloating 4/29 (possibly prior) - present
52 2021-05-10 feeling cold, cold sweat has not been feeling well; low blood pressure; feeling very cold; clammy; This is a spontaneous repo... Read more
has not been feeling well; low blood pressure; feeling very cold; clammy; This is a spontaneous report from contactable consumer. This contactable female consumer (Patient) reported for herself. A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included metoprolol (METOPROLOL) taken for hypotension, start and stop date were not reported. On an unspecified date She received the first dose on Monday at 07:00PM and had not been feeling well. Patient had been experiencing low blood pressure and feeling very cold and clammy. Patient did not take her heart medication (Metoprolol) because of the low blood pressure. The patient went to the ER but she says they didn't know what to do. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-05-10 feeling hot Within few mins heart raced and was hard beats and felt hot. Lasted about one minute. Felt breathi... Read more
Within few mins heart raced and was hard beats and felt hot. Lasted about one minute. Felt breathing was off for about an hour.
52 2021-05-10 pain in extremity Her arm was swollen all the way down to her wrist; part under her arm pit was very sore and swollen;... Read more
Her arm was swollen all the way down to her wrist; part under her arm pit was very sore and swollen; extremely painful and relaxing by her side was uncomfortable; extremely painful and relaxing by her side was uncomfortable; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-years-old female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; Batch/Lot Number was ER8731; Expiration date: Unknown), via an unspecified route of administration in Arm Right on 14Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date, The patient stated she is calling regarding the Pfizer COVID19 vaccine and has some questions about that. Got the shot about 3 weeks ago and her arm was swollen. The part under her arm pit was very sore and swollen. It did not turn red. She had swelling in her armpit area, for 3-4 days it was very swollen, her arm was swollen all the way down to her wrist and really painful right underneath her arm, The part under her arm pit was very sore and swollen. It did not turn red. Even to put deodorant on was extremely painful and relaxing her arm by her side was uncomfortable. The patient would like to know whether she should get the next dose of the Pfizer COVID vaccine after the side effects she had from the 1st dose. She had called the doctor and they said that it happens sometimes. Does not know if she should get the second shot. Confirmed that the shot was the first dose of the COVID vaccine. Is signed up for the second shot 05May2021. She had COVID and does not want to get it again. Do not want to spread to others. On an unspecified date the patient underwent lab tests and procedures which included antibody test: positive for antibodies, sars-cov-2 test was negative. Had tested negative when she thought she had it and got an antibody test a few weeks later that was positive for antibodies. There is no product complaint to report. Yes, there is a medical information request. No follow-up attempts are needed. No further information is expected.
52 2021-05-11 breast pain I had pain and soreness in my right breast for about 1 week. It was continuous.
52 2021-05-11 cold sweat Pt received 2nd dose of Pfizer vaccine. Pt in post observation and reported feeling "clammy and abou... Read more
Pt received 2nd dose of Pfizer vaccine. Pt in post observation and reported feeling "clammy and about to pass out, lightheaded". Pt appeared shaky. Pt reports hx of hypoglycemia, borderline diabetic. Pt given apple juice by clinician. Aid called to assess and treat Pt. Pt cleared by Aid at 11:45am and cleared by Aid to drive home. Pt reports "I feel ok to drive". Time duration from onset to clear=9 min. VS per EMT at 11:45 BP 122/86 HR 92 Temp 98.8F O2 sat 100% on RA BG 82
52 2021-05-11 pain in extremity had an allergic reaction to it; cellulitis of left upper extremity; Panniculitis; Persisting pain; P... Read more
had an allergic reaction to it; cellulitis of left upper extremity; Panniculitis; Persisting pain; Pain in arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 52-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 09Apr2021 (Lot# EW0162), at single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, blood pressure. Concomitant medication included unknown blood pressure medicine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 19Mar2021 at 09:15 (Lot# ER2613) for COVID-19 immunisation with no adverse effect. The patient had an allergic reaction to the 2nd dose of the vaccine. She stated that it burned her skin, her skin came off, skin was burning and i red. She was burning on left arm/extremities burning sensation of. It opened up and made a wound. It spread from her inner arm gone on the top of her breast, it was warm to the touch, it was burning in the inside of her. She had redness that turned into bruising. She could see a red circle and a red circle going down her arm getting bigger and redder. There were bruise marks like a map on her arm. The symptoms were spreading more on her body, and it was redder and warmer to touch. The bottom of her arm where the muscle would be at like the bicep or whatever part this is, was burning to move her arm and just burning. Her arm was on fire. Looking at her chest where her armpit is going to the top of her shoulder there was a red big spot. There were 5 big spots that came overnight going down her right breast. It was red, like a burgundy bruise. It was a burning hot sensation and was hurting inside, not outside. It was burning on the inside, and that was what was making burns come on outside of the skin. While she was in the hospital they diagnosed cellulitis of the left upper extremity. A neurologist thought she had panniculitis on left arm. The doctors thought it was an infection. The events required emergency room visit and physician office visit such as personal care physician, a wound doctor, dermatologist, neurologist, allergist, epidemiologist and an infectious disease doctor. Therapeutic measures were taken as a result of the events and included treatment with Levaquin 750 mg oral, Vancomycin, steroids, sildersulsadiazine cream, Clobetasol Propionate cream, Silvadene, Polysporin (lot# 1480Z, Exp date 20Apr2022) or Bacitracin, ice, Curad things for her dressing. During hospitalization the patient underwent lab tests and procedures which included blood work, X-ray, ultrasound all with unknown results. The patient was hospitalized from 13Apr2021 to 20Apr2021 for drug hypersensitivity, skin burning sensation, erythema, skin exfoliation, burning sensation, contusion, wound. Outcome of all events was unknown except for erythema , burning sensation and contusion which was not recovered.
52 2021-05-11 pain in extremity Doctor diagnosed shingles severe neck pain and arm pain. Rash on arm in 3 places. On family leave ... Read more
Doctor diagnosed shingles severe neck pain and arm pain. Rash on arm in 3 places. On family leave from work. Couldn?t use my right arm Doctor noted might be a reaction from Covid vaccine
52 2021-05-11 tremor Chills; Shakes; Fever; Insomnia; Trouble breathing; Cough; Diarrhea; Fatigue; Sweats and body aches ... Read more
Chills; Shakes; Fever; Insomnia; Trouble breathing; Cough; Diarrhea; Fatigue; Sweats and body aches including a headache; Sweats and body aches including a headache; Sweats and body aches including a headache; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 52-year-old-female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and gastroesophageal reflux disease, both from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included valaciclovir hydrochloride (VALTREX), lansoprazole (PREVACID), bupropion hydrochloride (WELLBUTRIN), and fluoxetine hydrochloride (PROZAC), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EN6202) on 19Mar2021 at 09:00 (at the age of 52-years-old) for COVID-19 immunisation. On 09Apr2021 at 21:15 the patient experienced chills, shakes, fever, insomnia, trouble breathing, cough, diarrhea, fatigue, sweats and body aches including a headache. The events were reported as non-serious, and no treatment was received for the events. The clinical outcomes of chills, shakes, fever, insomnia, trouble breathing, cough, diarrhea, fatigue, sweats and body aches including a headache were recovered in Apr2021. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
52 2021-05-12 difficulty speaking 4:11 pm tightness and swelling of throat; 4:30 pm anaphylaxis - s/sx swelling of throat and tongue, ... Read more
4:11 pm tightness and swelling of throat; 4:30 pm anaphylaxis - s/sx swelling of throat and tongue, difficulty swallowing, dysphonia, hypertension, low saturation, hoarseness; 4:35pm Tx Epinephrine 0.3 mg IM, ECG, Benadryl 75 mg IV, 5:05pm transport to hospital, ECG, 5:15pm ECG, 5:35 pm famotidine IV, methylprednisolone sodium succinate IV Have had chronic dysphonia since.
52 2021-05-12 flushing Pt c/o flush and sweaty approx 30 min post-vaccination. Symptoms resolved with rest. Denies chest pa... Read more
Pt c/o flush and sweaty approx 30 min post-vaccination. Symptoms resolved with rest. Denies chest pain, palpitations, SOB. Discharged home in stable condition. SpO2 98% RA Respirations unlabored. BP 116/68 HR 66
52 2021-05-12 hot flush Shingles; pain in her left blade of her shoulder and back on fire; it burns, hurts, and itches and i... Read more
Shingles; pain in her left blade of her shoulder and back on fire; it burns, hurts, and itches and is slightly inflamed and puffy; pain in her left blade of her shoulder and back on fire; it burns, hurts, and itches and is slightly inflamed and puffy; pain in her left blade of her shoulder and back on fire; it burns, hurts, and itches and is slightly inflamed and puffy; pain in her left blade of her shoulder and back on fire; it burns, hurts, and itches and is slightly inflamed and puffy; pain in her left blade of her shoulder and back on fire; it burns, hurts, and itches and is slightly inflamed and puffy; gets sweats and heat flashes. States when she breaks out in a sweat it burns her skin and the left side of her back; gets sweats and heat flashes. States when she breaks out in a sweat it burns her skin and the left side of her back; gets sweats and heat flashes. States when she breaks out in a sweat it burns her skin and the left side of her back; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 52 years, on 12Mar2021 15:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus diagnosed at least 10 years ago and covid-19 from 12Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient further stated shortly after her shot, she started to get pain in her left blade of her shoulder and it has been on fire since. She stated she has been to the urgent care twice and to her doctor treats her. She stated she got a shot and was treated for shingles and finished all courses and states it is burning like shingles, but it is not, they say it is shingles, it burns, hurts, and itches. It was also stated she had no issues until after the Covid shot on the twelfth. She stated she went to the Urgent Care and they said she had shingles and she took antiviral stuff and it has been 3 weeks and she hasn't gotten better. It was stated it was only after she had the vaccine. It was also stated she had the shot in her left arm and was fine for short time and then her back and arm started burning. She stated she went to the urgent care and they gave her a Cortisone shot and it lasted an hour and then it returned. She stated she was not on drugs, no pot, crack. She was calling to report this and see if maybe people are reporting symptoms like this. She stated it was on fire and feels like a sunburn. She stated she gets sweats and heat flashes. She stated when she breaks out in a sweat it burns her skin and the left side of her back. She also stated her friend was a doctor and said it is slightly inflamed. It was stated if she has shingles, they might be below surface. She stated there are no visible sores but it was inflamed and puffy. Therapeutic measures (CBD ointment, Cortisone shot and prescription topical cream, Tylenol) were taken as a result of shingles, arthralgia, back pain and skin burning sensation. The outcome of the events was not recovered. Information on the lot/ batch number has been requested.
52 2021-05-12 muscle spasms, tremor Occurring in Right Arm approx. daily: Muscle spasms, shaking arm and hand, pain shooting down arm in... Read more
Occurring in Right Arm approx. daily: Muscle spasms, shaking arm and hand, pain shooting down arm into wrist (painful enough to make me stop what I am doing), unable to make a fist, muscle weakness.
52 2021-05-13 electric shock sensation Shot #1: Pain at injection site for 3 days. Itching from top of head to bottom of feet (entire bod... Read more
Shot #1: Pain at injection site for 3 days. Itching from top of head to bottom of feet (entire body) for 6 hours. Brief sharp pain in right chest only once. Major fatigue for 10 days. Shot #2: Pain at injection site for 3 days. Body aches for 7 days. Fever with chills and sweating for 5 days. Nausea and lack of appetite off/on for 7 days. Severe headache with electrical storm throughout head for 5 days. Tried Tylenol 1,000mg TID which barely dulled the pain. Oxycodone 5mg (left over prescription) did not help (tried twice). Major fatigue for 14 days followed by tapering of fatigue over next 13 days (today).
52 2021-05-13 feeling cold, pain in extremity Got lower back pain and joint pain the next day after first does , lower back pain sometimes bette... Read more
Got lower back pain and joint pain the next day after first does , lower back pain sometimes better sometimes worse for more than one month. At the six week post vaccine, lower back pain almost gone, and got the second dose of the vaccine. Got fever, chill , joint pain and lower back pain the next day of the second dose. Fever, chill, joint pain went away within two days. Lower pack pain do not go away., still hurting now, and 5 days ago pain go down to legs, feel leg weakness, leg muscle pain and tense. Had to take days off from work due to the lower back pain.
52 2021-05-13 feeling hot Bruise; She had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot;... Read more
Bruise; She had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot; She had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot; She had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot; She had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot; She had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: ER2613; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Left on 13Apr2021 14:15 (at the age of 52-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included, she lost 85 pounds in 9 months from an unknown date. The patient received first dose of bnt162b2 on 22Mar2021 in her left arm. Lot: EP6955. It might by SS, there are no dashes. It looks like EP or ER 6955. Expiration date: Jun2021. The patient's concomitant medications were not reported. Caller states that when she gets her second dose, she had it in the same arm that she received her first dose and reports the next evening she had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot. Caller states she just assumed this was normal and did not think anything of it. She reports that over the last 3 weeks this has slowly gotten smaller and report it is the "size of an eraser" that she can feel if she presses on her skin. She states that she has also now noticed that there is a bruise and states that she did not initially have any bruising. Caller would like to know if this bruising is normal with the vaccine as she is concerned since it has been so long since she received her second dose. The patient didn't know who else to call. She had her first Covid shot and waited 3 weeks, then she got the second. She got the second one 3 weeks ago today, and she got it in the same arm. With the second shot she noticed by the next day, it didn't hurt to raise her arm and it didn't hurt until she touched it. She had a swollen area on her arm the size of a goose egg. Over the last 3 weeks it has finally shrunk and is now the size of a grain of rice. Now that it has shrunk, a bruise has appeared. She feels fine. She doesn't have Covid. She smokes, that's why she is coughing. She was wondering if this was something serious. It has been 3 weeks and she still has a bruise. Caller declines to provide a physician. She has not been to a doctor in years. She can't tell the last time she went to a doctor. The patient noticed the swelling the next day on 14Apr2021. She can still feel a little knot maybe the size of an end of a pencil. It has slowly gotten smaller over the last 3 weeks. It was the size of a goose egg, bigger than a regular chicken egg. She assumed it was because she had both shots in the same arm. She should have had it in her other arm. It would have been in the evening maybe around 2200 or 2300 at night because she was just about to go to bed. The lights were out in the living room and she came charging out of her bedroom and caught her arm on the door. She thought oh that hurts and put her hand over it and noticed a goose bump. The outcome of the event bruise was not recovered, swelling was recovering, and she had a "goose egg" under her skin that was swollen, hard, painful to touch, red, and hot were unknown. Follow up #1 (04May2021): This is a follow up-spontaneous report received from a contactable consumer reported that the date of vaccination, event and clinical information. No follow-up attempts are needed. No further information is expected. .
52 2021-05-13 tingling, feeling hot Started feeling waves of heat across chest 2 days after vaccine, called advise nurse multiple times ... Read more
Started feeling waves of heat across chest 2 days after vaccine, called advise nurse multiple times during first week and emailed doctor's office. Experienced low back pain on day 3 lasted for three days, day 5 developed tingling feet. Tingling in feet persisted and occasionally in hands the following week Went to doctors the following week for checkup on 5/6/21 Doctors notes: PARESTHESIA Note: ? Etiology Possibly COVID vaccine related ? Check labs. Monitor symptoms, follow up if worsening. ELEVATED BP READING WO HTN DIAGNOSIS Note: check labs Return 2 weeks blood pressure check.
52 2021-05-14 numbness, tingling Pfizer-BioNTech COVID-19 Vaccine EUA Waves of vertigo Waves of tingling and numbness in lips, face, ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Waves of vertigo Waves of tingling and numbness in lips, face, and extremities (especially left side) Heaviness in calves/feet
52 2021-05-14 numbness throat felt swollen ,and soar my lungs felt raw like when you have bad congestion; throat felt swoll... Read more
throat felt swollen ,and soar my lungs felt raw like when you have bad congestion; throat felt swollen; Arm swollen muscles very painful through neck into jaw down my left side into my leg ,down to ankle, jaw felt numb at times; Arm swollen muscles very painful through neck into jaw down my left side into my leg ,down to ankle; shoulder pain; nausea; chills; Jaw felt numb at times; extremely tired; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 23Apr2021 10:45 AM at the age of 52-years-old (Batch/Lot Number: ER8735) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included cardiomyopathy from an unknown date. The patient did not have known allergies. Concomitant medications included metoprolol and lisinopril, taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 02:00 PM, the patient experienced arm swollen, muscles very painful through neck into jaw down my left side into my leg ,down to ankle, jaw felt numb at times ,shoulder pain went on for 7 days ,nausea ,chills ,extremely tired ,her throat felt swollen ,and soar her lungs felt raw like when you have bad congestion ,hard to function tired all week. The patient did not want to take 2nd dose too many side effects. Therapeutic measures were taken included Tylenol, Asprin, loratadine famotidine tums. The outcome of the events was resolving.
52 2021-05-14 pain in extremity she is having diarrhea.; some stomach issues; sore arm; This is a spontaneous report from a contacta... Read more
she is having diarrhea.; some stomach issues; sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated she received the first dose of the vaccine on 19Jan2021 and the second dose 3 weeks later on 09Feb2021. She stated she did not have any side effects after either dose other than a sore arm on an unspecified date Feb2021. However today she is having diarrhea. She asked if this could still be related to the vaccine and how long she might experience this. The patient was vaccinated both doses of the Pfizer Covid19 vaccine. The first one on 19Jan and the second one on 09Feb. So, that is 3 weeks apart and I have zero side effects from both. The first time my arm hurt a little bit more than the second time. So, it has been 6 days since the patient had the second dose and today she was having some diarrhea and some stomach issues on 15Feb2021, the patient treatment received 2 Imodium. Would it be possible that it stated from the vaccine 6 days ago or not. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (12MAY2021): Follow-up attempts completed. No further information expected
52 2021-05-14 pain in extremity Hives all over her body; Rash all over her body; Pain in arm; This is a spontaneous report from a Pf... Read more
Hives all over her body; Rash all over her body; Pain in arm; This is a spontaneous report from a Pfizer-Sponsored program from a contactable consumer (patient). A 52-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in deltoid left, on 21Apr2021 (Lot Number: EW0172), as single dose, for COVID-19 immunisation. Medical history was none. No history of allergies or autoimmune disease. Concomitant medications were not reported. The patient experienced hives all over her body (medically significant) on 02May2021 with outcome of not recovered, rash all over her body (medically significant) on 02May2021 with outcome of not recovered, pain in arm (non-serious) on 02May2021 with outcome of unknown. Therapeutic measures were taken as a result of hives all over her body and rash all over her body and included treatment with antihistamine, Benadryl. Follow-up attempts are needed. Further information is expected.
52 2021-05-16 numbness Six days after second injection my toes turned purple/red and swollen. The skin peeled off and I hav... Read more
Six days after second injection my toes turned purple/red and swollen. The skin peeled off and I have had numbness and pain since. Three weeks on, they are still painful and red
52 2021-05-16 pain in extremity, weakness Light headed, extreme foggyness, confusion, body aches, chills, headaches, extreme fatigue, feeling ... Read more
Light headed, extreme foggyness, confusion, body aches, chills, headaches, extreme fatigue, feeling of being drugged, extreme lower body & back pain, nausea, confusion, loss of appetite, low energy, stomach pain, feeling extremely sick all over
52 2021-05-17 muscle spasms Severe muscle spasms in lower back, treated with Tylenol, ice pack, heat pack, CBD cream, rest, chir... Read more
Severe muscle spasms in lower back, treated with Tylenol, ice pack, heat pack, CBD cream, rest, chiropractic adjustment. Slow improvement over the course of 4 days (day 5 since vaccine still minor inflammation/pain at low back)
52 2021-05-17 pain in extremity sore arm. Fever 103.8, head ache, body aches, lightheadedness
52 2021-05-18 inability to speak pt says next day after taking the vax she started having a burning joint pain in her left shoulder a... Read more
pt says next day after taking the vax she started having a burning joint pain in her left shoulder and the arm pit lymph node is swollen. The joint pain went across to the other shoulder joint. The pain went from her right shoulder down to her elbow, to her wrist down to her hip, knee and ankle. The pain moved to all of the joints on the right side of her body. Her blood pressure was going up. It went from 110/70 to 149/89. She gets a severe pain on the right side of her head like a headache. She has a constant ringing in her head. She has short term memory loss and expressive aphasia. She went to OB/GYN on 3/3/21. He sent her to see her PCP NP on 3/7/21. She was given a Medrol dose pack and antibiotics. Pt had lab work. She wasn't getting better so went back about a week later and saw Dr. She was prescribed 40 mg of prednisone. She was referred to Neurologist. He ordered her an MRI and EEG. The MRI showed 3 spots on it which doctor want overly concerned about but the EEG was abnormal so she was rescheduled for further testing on 9/28/21.
52 2021-05-18 pain in extremity frontal headache for 3 days, left arm pain for 3 days and swelling, general fatigue for 1 week, redn... Read more
frontal headache for 3 days, left arm pain for 3 days and swelling, general fatigue for 1 week, redness on the tongue, middle anterior part as if it were burned, and the middle distal part a whitish plaque for two days as if I had oral candidosis, Then it started at 300 am I felt something so intense that I woke up, as if the brain were tipping me inside my head and vertigo began, everything turned me when I opened my eyes, as if I had drunk a lot of alcohol and everything gave around me when I opened my eyes, it was lake so strong that I felt that I was falling from my bed,I had to go to my primary doctor because when I changed the position of my head and lowered it, the severe vertigo began and I had to hold on to avoid falling.Then I decided to get the second dose to complete my vaccination despite these adverse effects, the doctor indicated drugs for vertigo and examined me, and now 2 weeks ago that after having a year without menstruation, I was already in menopause, I I have profuse bleeding with clots and I have been bleeding for 15 days.
52 2021-05-18 pain in extremity sore arm; fatigue; general malaise; muscle aches; This is a spontaneous report from a contactable co... Read more
sore arm; fatigue; general malaise; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL-3247), via an unspecified route of administration on 15Mar2021 at 14:00 (at the age of 52-year-old), as 2nd dose, single, in left arm for COVID-19 immunization at Workplace Clinic. The patient's medical history included atrial fibrillation. Patient had no known allergies. Concomitant medications received within 2 weeks of vaccination included Famotidine, low dose aspirin, 1000 IU vitamin D. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL-3247), via an unspecified route of administration on 22Feb2021 at 14:45, as single dose in left arm for COVID-19 immunization. On 15Mar2021 at 15:00, the patient experienced sore arm 1 hr after injection to 24 hours; fatigue within 3-4 hours; fatigue and general malaise at 6-24 hours; muscle aches from 6-24 hrs after vaccination. There was no treatment received for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
52 2021-05-18 pain in extremity 14 hours after vaccine: nausea, screaming headache, arm so sore I couldn't lift it, fatigued INSOMN... Read more
14 hours after vaccine: nausea, screaming headache, arm so sore I couldn't lift it, fatigued INSOMNIA. Starting the second night after the vaccine: insomnia. Feeling "wired." Could only sleep for about 3-4 hours. The insomnia reoccurred every other night for the next 12 nights. I've never ever experienced insomnia before this, in my 52 years. I'm not sure if I need to fill out another form--but after my second Pfizer dose (lot #EW0171), I experienced insomnia again the third night after the vaccine--and two or three other times over the next three weeks.
52 2021-05-18 pain in extremity This is a spontaneous report from a contactable consumer. A 52-years-old female Non pregnant patient... Read more
This is a spontaneous report from a contactable consumer. A 52-years-old female Non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: EL3247) dose1, via an unspecified route of administration in Arm Right on 27Jan2021 11:00 as 1ST DOSE, SINGLE for covid-19 immunization. No prior vaccination and did not tested after post vaccination. Medical history included drug hypersensitivity, known allergies penicillin. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced continue chronic pain in right upper arm where 1st dose vaccine was administered, limited range of motion a large bruise at injection site, a large bruise at injection site, Upon follow-up on 18Mar2021, it was reported that arm pain, lack of mobility occurred about 6 hours after the vaccine was administered on 27Jan2021. Therapeutic measures were taken as a result of continue chronic pain in right upper arm where 1st dose vaccine was administered, limited range of motion, a large bruise at injection site. The clinical outcome of the events were not recovered and arm pain, lack of mobility of the outcome was unknown. Follow-up (18Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Additional events were updated (arm pain, lack of mobility) and updated event onset date. No follow-up attempts are needed. No further information is expected.
52 2021-05-19 weakness 2nd dose Nausea, severe headache , severe muscle pain in legs, buttocks, ankle joint pain , itchin... Read more
2nd dose Nausea, severe headache , severe muscle pain in legs, buttocks, ankle joint pain , itching at sit L arm; , could not left left arm, stomach ache, eye pain, delirious, feeling extremely tired and unwell, loss of appetite, chills , swollen glands at throat, sore throat. Weakness, confusion, eye pain. Dizziness.
52 2021-05-19 weakness Swollen glands in neck and loss of voice, weak, lightheaded, vomiting, chills, body aches, extreme t... Read more
Swollen glands in neck and loss of voice, weak, lightheaded, vomiting, chills, body aches, extreme thirst, constant sleep, heart rate high within 48 hours. At 48 hours, severe breathing issues and small sores on upper arms and chest. Now on day 5, shortness of breath continues, spells of sweating, no sleep for 2 days, and a fluid filled Knoton lower front neck. Had to miss a day and a half of work so far this week
52 2021-05-19 tremor, cold extremities brain fog; tired; Cold hands and feet; rapid heart beat; body aches; shaky; anxiety; insomnia; This ... Read more
brain fog; tired; Cold hands and feet; rapid heart beat; body aches; shaky; anxiety; insomnia; This is a spontaneous report from contactable other healthcare professional as a patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL9267) via an unspecified route of administration on 24Feb2021 at 15:30 pm in the left arm as a first dose for COVID-19 vaccination (age at the vaccination 52-years-old). Medical history and concomitant medications were not provided. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19 (details unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 25Feb2021, the patient experienced cold hands and feet, body aches, tired, shaky, rapid heart beat, insomnia, anxiety and brain fog. The patient did not receive treatment for adverse events. The outcome of the events of cold hands and feet, body aches, tired, shaky, rapid heart beat, insomnia, anxiety and brain fog was reported as recovered. No follow-up attempts are needed. No further information is expected.
52 2021-05-20 difficulty speaking Approximately 20 minutes after injection, I experienced tingling sensation of tongue with mild swell... Read more
Approximately 20 minutes after injection, I experienced tingling sensation of tongue with mild swelling, pharyngeal pruritis, increased mucus production causing coughing, nasal congestion, and constant throat clearing, globular sensation when swallowing, voice became hoarse. I reported to nurse monitoring patients post injection. Was asked regarding symptoms and told to take medications that I had brought with me. Medications were Pepcid 20 mg, Benadryl 50 mg, Prednisone 10 mg. I was monitored for another 90 minutes. Symptoms began to resolve approximately 30 minutes after taking medications. Full resolution of symptoms occurred approximately 8 hours after taking medications. Followed nurse's instructions and immediately notified PCPs office upon returning home. PCP recommends to not receive 2nd Pfizer vaccine.
52 2021-05-20 difficulty speaking Within approximately 15 minutes appreciating the vaccination I began to feel light-headed and nauseo... Read more
Within approximately 15 minutes appreciating the vaccination I began to feel light-headed and nauseous. That sensation continued 4 the next week and finished approximately Friday, May 14th. An approximately May 11th, I started experiencing sporadic, cough, runny nose, sore throat, chills, headache, dull pain in eyes and sharp joint pain. Additionally I felt as if I had a fever but I had been taking Tylenol two to three times a day. Most of these symptoms drafted from approximately the 11th through 14th. I had a chest x-ray on the 13th with negative results. I have covid rapid test shortly before and again on the 14th both with negative results. I also noticed swelling at the base of my neck I'm around May 11th which has persisted to date. I am assuming this is due to swollen lymph nodes although such has not been confirmed by health professional. I reported my symptoms at the vaccination site. The nurse was prepared to use my EpiPen but such was not needed. I left the site after waiting about 45 minutes even though my nausea and lightheadedness remained. Presently I still have headaches throughout the day, sore throat and a hoarse voice.
52 2021-05-20 hot flush drop in estrogen and menopausal issues ever since that had never experienced, hot flashes dryness ir... Read more
drop in estrogen and menopausal issues ever since that had never experienced, hot flashes dryness irritation
52 2021-05-20 numbness 1. Left side facial numbness 2. Anxiety 3. Smile is symetrical 4. Protruding tongue centered 5. Elev... Read more
1. Left side facial numbness 2. Anxiety 3. Smile is symetrical 4. Protruding tongue centered 5. Elevated BP 172/112 approx. 10:30am 6. 2nd BP reading 153/93 10:58am 7. 3rd BP reading 146/89 11:15am 8. O2 Sats 98% on RA 9. HR 72, RR 18
52 2021-05-21 weakness, muscle spasms, pain in extremity PFIZER VACCINE- DOSE 1 -4/30/2021 5/7/2021- SUDDEN ONSET UTI- UNSPECIFIED HEMATURIA- SUGAR IN URINE... Read more
PFIZER VACCINE- DOSE 1 -4/30/2021 5/7/2021- SUDDEN ONSET UTI- UNSPECIFIED HEMATURIA- SUGAR IN URINE LEG CRAMPING/PAIN FATIGUE SEVERE PELVIC PAIN SEVERE BACK PAIN SHORTNESS OF BREATH HEART PALPITATIONS DURATION- STARTING 5/1/2021- CURRENTLY 5/14/2021 SUDDEN ONSET- UTERINE/VAGINAL BLEEDING -PROFUSE!!! DURATION- 5/14/2021- 5/17/2021- PROFUSE/HEAVY 5/18/2021- 5/22/2021 (AS OF THIS SUBMISSON)- LIGHT SPOTTING (NOTE- LAST MENTRUAL CYCLE- 2/2021- DID NOT MENSTRUATE 3/2021 OR 4/2021) DIZZINESS/RACING HEART/LEG PAIN/CHEST PAIN/SHORTNESS OF BREATH/THIRST/EXTREME WEAKNESS AND FATIGUE
52 2021-05-21 electric shock sensation In an hour time I feelt an electric shock ( Like a live wire) travel up my back into the top roof of... Read more
In an hour time I feelt an electric shock ( Like a live wire) travel up my back into the top roof of my mouth, My mouth muscles tighten down, my lips started to tingle and swell. The fever hit me 20 minutes later. I took allergy pills and ibuprofens for two days straight. I fell asleep right after I took the first set of allergy pills. I would wake off on on for the next three hours to chew on ice for my lips and mouth. These symptom last for two days.
52 2021-05-21 tingling Severe arm pain that radiated from site of injection to her elbow and neck. feels like it is tinglin... Read more
Severe arm pain that radiated from site of injection to her elbow and neck. feels like it is tingling
52 2021-05-23 tingling, feeling cold 52 yo Female had symptoms of anxiety ( tachycardia, racing thoughts about vaccine) and hyperventilat... Read more
52 yo Female had symptoms of anxiety ( tachycardia, racing thoughts about vaccine) and hyperventilation syndrome ( tachypnea, paresthesia or tingling sensation on her fingers ) 14 minutes after receiving her 1st IM dose of Pfizer.COVID 19 vaccine. She has no prior history of anaphylaxis but had adverse reaction to acetaminophen years ago when she felt nauseated , with tingling sensation of fingers but no associated angioedema or low blood pressure , no prior treatment with Epipen IM. She occasionally have similar symptoms at home after work but milder as per her husband . Other risk factors : she missed breakfast and did not bring food for lunch , or snack, took only coffee few hours before vaccine . She is taking medications for her menopause symptoms which she did not take today. She received her 1st Pfizer IM dose at 12:15 PM and 14 minutes later called the attention of the EMT and physician at vaccine clinic that she had stomach discomfort, felt nauseated , cold , with palpitations , followed by tingling sensations of her fingers. She had no difficulty breathing or swelling of her throat, no hoarseness. She denied lip swelling and throat tightness. She admitted she had racing thoughts in her head. She was at observation area and immediately moved to the close observation area via wheelchair. She continued to be alert and oriented, appeared pink , no near syncope but was breathing fast ( 20-22/min) with sigh breaths. Initial vital signs showed stage 2 hypertension , 160/100mmHg ( MAnual BP) , HR 101/min, SpO2 98 to 100% on room air, RR20-22/min. She was afebrile. Serial exams were done. She remained alert, oriented to place and person , clear vision, though felt ? dizzy? in the beginning, but improved after she was allowed to drink 1Tsp. of caramel syrup with water and ate a fig bar at 12:40 pm. She No focal weakness or deficits, but her distal fingers felt cold with paresthesia . HEENT: tongue appeared normal with Mallampati score 2. She did not develop stridor or hoarseness throughout observation. VS were repeated every 10 minutes , BP ranged from 140/ 80mmHg and later improved to 120-130/80 mmHg, SpO2 98% to 100%on room air, RR initially tachypneic 20-22/min but after she ate , drank water and reassured that her vital signs were improving , no strider , clear lungs to auscultation, RR improved to 16 to 18/min and HR in 70?s per min. She was accompanied by female vaccine staff to the restroom to urinate, no incident thereafter and she and her husband verbalized she was feeling better . Upon discharge home , she had resolved dizziness, resolving finger paresthesia , resolved sensation of coldness when given a foil wrap and a shawl, On exam , remained alert and oriented , HEENT exam without oral-mucosal swelling , no facial angioedema, verbalized chest tightness resolved after knowing he lungs were clear to auscultation. She did not develop stridor , appeared comfortable , with clear speech . She did not develop angioedema and and no hives. Tongue exam normal without angioedema. Eye exam normal. Chest clear breath sounds to auscultation, no wheeze, Heart Improved normal resting HR (70?s/min) , no murmur , good and equal radial pulses. Distal Upper extremities perfusion normal , were warmer to touch ( was cold initially ) , pink, and well perfused. Nausea and epigastric pain resolved , She was kept under close observation until full recovery. Since she did not have signs of anaphylaxis , thus she was not given epipen auto injection. She did not develop stridor, no throat tightness ; her tachycardia resolved and her BP gradually improved to 130/80 mmHg) with rest and sustained improvement until time of discharge home with her husband . Approximate duration of observation was 80 minutes. They were initially offered to go to urgent care if they elected to be observed elsewhere but they decided to stay behind until she felt improved and reassured that her exam and VS were improving. She was able to stand up, observed to have normal gait , was escorted to her car with no further incident. She and her husband verbally agreed to have her condition reported to VAERS. They were advised to read and follow advise of Pfizer EUA handouts. If her symptoms worse. ( difficulty breathing, chest tightness , pallor , dizziness , to call 911 and bring to nearest ER. They were also asked to follow up with their primary care provider to consider options available for the second COVID 19 vaccine and monitor her BP and symptoms suggestive of anxiety. Follow phone call done, she did well after going home but the next day , more than 24 hours after vaccine was given , she felt chest tightness , was brought by her husband to Medical Center , patient verbalize her sus BP was 174 and DBP mid 90?s. She did not recall any injected medication , was observed and sent home with symptom improvement . Upon phone follow today, 5/25, she verbalized she is feeling better and resting at home. She acknowledged high BP as describe as above but asymptomatic now. She will follow up with her primary care physician on 5/26/2021.
52 2021-05-23 tingling Blue Fingers the next day. A few weeks later have tingling in whole body, mostly legs and hands. Blu... Read more
Blue Fingers the next day. A few weeks later have tingling in whole body, mostly legs and hands. Blurred vision. Black and blue marks on in back of lower legs. Veins protruding in hands and continue to be blue.
52 2021-05-24 weakness Immediate unusual taste in mouth, followed by headaches, fatigue, fever, breathlessness, weakness, u... Read more
Immediate unusual taste in mouth, followed by headaches, fatigue, fever, breathlessness, weakness, unusual pain. Just found out my heart is enlarged.
52 2021-05-24 numbness, throat numbness, feeling hot Patient felt warm, numbness in arms and legs, throat got numb and "tight." Patient given Benedryl 5... Read more
Patient felt warm, numbness in arms and legs, throat got numb and "tight." Patient given Benedryl 50mg IV and transported to ER by EMS.
52 2021-05-24 pain in extremity Lingering joint Pains, Leg and calf pain
52 2021-05-25 tremor, tingling, muscle spasms, cold extremities, burning sensation, weakness, electric shock sensation April 5th 10-15 minutes after dose: tight throat and chest, congested, feeling out of it within 10-... Read more
April 5th 10-15 minutes after dose: tight throat and chest, congested, feeling out of it within 10-15 minutes after dose Later that day: tachycardia, burning sensation throughout body, tingling in nasal passage, arms and legs, lower back pain, lightheaded, joint pain, chills April 6th additional symptoms to above and ongoing at various degrees: migrating shock sensation, cold extremities, swollen lymph nodes, shaking, ear ringing, fatigue, muscle cramping and stiffness, unsteady while sitting and standing, back weakness, periodic cough, nausea
52 2021-05-26 bell's palsy, numbness Patient presented to her primary care provider on 2/11/2021 with right ear pain, numbness on right s... Read more
Patient presented to her primary care provider on 2/11/2021 with right ear pain, numbness on right side of face and head, full feeling on right side of throat and right eye dryness. Patient had received 2nd dose of Pfizer COVID19 vaccine on 2/2/2021 and started feeling itchy from head to tow that lasted 24 hours. Was diagnosed with Bell's Palsy at this visit. Patient then presented to the Emergency Dept on 2/13/2021 with shortness of breath.
52 2021-05-26 bell's palsy, numbness Patient presented to her primary care provider on 2/11/2021 with right ear pain, numbness on right s... Read more
Patient presented to her primary care provider on 2/11/2021 with right ear pain, numbness on right side of face and head, full feeling on right side of throat and right eye dryness. Patient had received 2nd dose of Pfizer COVID19 vaccine on 2/2/2021 and started feeling itchy from head to tow that lasted 24 hours. Was diagnosed with Bell's Palsy at this visit. She then presented to the Emergency Department on 2/13/2021 with shortness of breath.
52 2021-05-26 pain in extremity Arm is sore; slight fatigue; slight fever; Body is achy all over; Headache; Bruising at the site of ... Read more
Arm is sore; slight fatigue; slight fever; Body is achy all over; Headache; Bruising at the site of injection; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot/batch no EL3247) dose number 1via an unspecified route of administration on the left arm on 23Feb2021 at 02:30 and second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot/batch no: EN6203) on 16Mar2021 at 02:30 (at the age of 52-year-old) via an unspecified route of administration on right arm as a single dose for COVID-19 immunisation . Medical history included thyroid disease. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Synthroid, Centrum, Magnesium, Vitamin C since an unknown date for unknown indications and Vitamin C was taken daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 17Mar2021 the patient experienced arm sore, bruising at the site of injection, body ache all over, slight fever, headache and slight fatigue. Therapeutic measures taken for the reported events included Advil from an unknown date. The Clinical outcome of the events arm was sore, bruising at the site of injection, body was achy all over, slight fever, headache and slight fatigue was recovering. No follow-up attempts are needed. No further information is expected.
52 2021-05-26 tremor, night sweats On 04/15/2021 at 6:15pm, experienced severe joint pain, sharp headache, and felt pain/pressure in th... Read more
On 04/15/2021 at 6:15pm, experienced severe joint pain, sharp headache, and felt pain/pressure in throat area - it was difficult to swallow. No fever. Symptoms not present next morning but returned around 4:30pm on 04/16/2021 and continued on a nightly basis for over a week. On 04/30/2021 joint pain disruptive to sleep, work, regular activities, and also developed extreme night sweats, fatigue, severe anxiety, tremors, unintentional weight loss, and throat pain was increasing. Saw Dr. on 04/30/2021 and labs were ordered. Anxiety continued to increase, getting a deep breath almost impossible, and I could not work so went back to Dr.
52 2021-05-26 tremor She experienced headache; Low grade fever; Body aches; Chills; Uncontrollable shakes; High fever; Th... Read more
She experienced headache; Low grade fever; Body aches; Chills; Uncontrollable shakes; High fever; This is a report combining information from duplicate reports 2021146061 and 2021099401. The current and all subsequent information will be reported under manufacturer report number 2021099401. This is a spontaneous report from a contactable consumer. A 52-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Deltoid Left on 27Jan2021 as 2nd dose single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose on 07Jan2021. Medical history included menopausal symptoms, hot flush and insomnia from an unknown date and unknown if ongoing. Concomitant medications included zolpidem tartrate taken for menopausal symptoms, hot flush, insomnia, start and stop date were not reported, multivitamins taken for an unspecified indication, start and stop date were not reported. Over the counter medication for menopausal symptoms. Had hot flashes and was not sleeping well so she started it. She has been on it for 3 months. Product spelling confirmed and documented by caller. Caller states she is healthy and is an avid runner. She is very active. Time the Vaccination Was Given as she received both doses around noon. On an unspecified date patient experienced she experienced headache, low grade fever, body aches, chills, uncontrollable shakes and high fever. She noticed the headache the day after she got the vaccine, but it has gotten worse. She still has the headache. She felt good the day she got the vaccination. The next day she was achy, but she took Tylenol and was able to go to work. Saturday night she had uncontrollable shakes and high fever. She has this constant headache. The outcome of the event headache was not recovered whereas the other events was unknown. Follow-up (01Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported with patient general information. Follow-up (11Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding confirmation of start date of second dose. This report included that query raised on the date of first and second dose and kept the first dose date in error. Follow-up attempts are completed. No further information is expected.
52 2021-05-27 weakness, tremor, pain in extremity First Dose 2/26/2021: 1. sore arm where shot was administered for about 5 days. 2. Two weeks after v... Read more
First Dose 2/26/2021: 1. sore arm where shot was administered for about 5 days. 2. Two weeks after vaccination I came down with flu like symptoms including: muscle aches, fever, chills, severe headache, and extremely tired which last for five days. 3. No medication would relieve the symptoms including the headache. 4. Had to stay in bed or on couch entire weekend. Second Dose 3/19/2021: 1. Five hours after vaccination, I cam down with the same flu like systems including: muscle aches, fever, chills and severe headache, which lasted for another five days. This time it also kicked off my Graves eye disease. 2. Shot made the arm feel very heavy and hard to use. 3. No medication would relieve the symptoms.
52 2021-05-27 numbness, pain in extremity She reported that her left arm was numb, very limp and sore. She said her right arm was weak. She h... Read more
She reported that her left arm was numb, very limp and sore. She said her right arm was weak. She had a fever of 102 degrees.
52 2021-05-27 numbness Left cheek numbness approximately 30 minutes after vaccine and lasted approximately 60 minutes.
52 2021-05-28 weakness headache; fatigue; weakness; joint pain; pain and redness at injection site; pain and redness at inj... Read more
headache; fatigue; weakness; joint pain; pain and redness at injection site; pain and redness at injection site; fever; fogginess; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6198 and Expiry date were not reported) dose 1, via unspecified route of administration, administered in left arm on 03Mar2021 at 17.30, single for COVID-19 immunization. The patient's medical history included a Covid-19, ankylosing spondylitis, hashimoto's thyroiditis, seasonal allergies, dander allergies, indoor allergies, chronic sinusitis, asthma. The patient had allergies with medication prochlorperazine, food chocolate. The patient did not receive any treatment. The patient was not Covid tested post vaccination.The patient took unknown concomitant medications in two weeks. On 03Mar2021 at 07:00 PM(1.30 mins after vaccination), the patient experienced a headache, fatigue, weakness, joint pain, pain and redness at injection site, fever, fogginess. The outcome of events were not recovered. No follow-up attempts are possible. No further information is expected
52 2021-05-28 feeling jittery My heart felt like it was racing, I was jittery. Back pain, shoulder pain. Arm pain where the shot w... Read more
My heart felt like it was racing, I was jittery. Back pain, shoulder pain. Arm pain where the shot was. Lower back hurts sometimes shoots into my chest. When the pain hurts it feels like the pain is coming from my back and shoots into the front of my chest. It makes it hard to breathe. I went to the ER from work. The ER asks me if I had Covid, and I told them I didn't think so I was never sick. They told me to contact my PCP, and she told me that I could take a muscle relaxer at night to help me sleep. Dr. also said to relax that she has heard of some people reacting this way and told me to give it time to go away.
52 2021-05-28 numbness, tenderness, facial paralysis Day after shot, right side facial paralysis Then changed to numb feeling around right eye and ache ... Read more
Day after shot, right side facial paralysis Then changed to numb feeling around right eye and ache behind eye ?Pulling? at right eye Tightness of scalp Ear ringing Tenderness/pain, right side of head Dry eye Nausea (comes and goes)
52 2021-05-28 migraine she has syncope and migraine; she has syncope and migraine; she did not feel good after the first sh... Read more
she has syncope and migraine; she has syncope and migraine; she did not feel good after the first shot.; This is a spontaneous report from a contactable consumer for herself. A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included cataract . The patient's concomitant medications were not reported. The patient experienced syncope on an unspecified date with outcome of unknown , migraine on an unspecified date with outcome of unknown , she did not feel good after the first shot on an unspecified date with outcome of unknown. No follow-up attempts are needed. No further information is expected.
52 2021-05-28 pain in extremity, cold extremities Sharp stabbing pain when I raise my right arm or move my arm towards the back. It has been over a mo... Read more
Sharp stabbing pain when I raise my right arm or move my arm towards the back. It has been over a month & the pain has not gone away. I have also noticed the temperature on my right hand is cold.
52 2021-05-28 pain in extremity the first day I had a sore arm. the second day I felt ok when I woke up until about 8 pm I was feeli... Read more
the first day I had a sore arm. the second day I felt ok when I woke up until about 8 pm I was feeling dizzy, hard to catch my breathe, and tired. I struggled at work, but made it through my shift. I was pale, dizzy, sweaty. The next day I had itchy eyes and throat. Eyes were red. I went to urgent care and was tested for Covid-19 and was negative. two weeks this continued, chronically tired. my doctor finally put me on steroids ,and after finishing them I was feeling better.
52 2021-05-31 burning sensation under arm started to burn, went and looked and glands had swollen up to golf ball size; under arm st... Read more
under arm started to burn, went and looked and glands had swollen up to golf ball size; under arm started to burn; Pain in joints; headache on right side; This is a spontaneous report from a contactable other health care professional (patient). A 52-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration administered in right arm on 02Feb2021 11:00 as a single dose for covid-19 immunization. Medical history included asthma, gluten allergy, fructose allergy, lactose allergy. Concomitant medications included calcium, tea, green, diindolylmethane (DIM), Asthma inhaler and Vit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient has not been tested for COVID-19. The patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unknown date as a single dose for covid-19 immunization. On 03Feb2021, the patient experienced pain in joints and headache on right side. In the evening at about 5:30, under arm started to burn, and glands had swollen up to golf ball size. No treatment was received for the adverse events. Seriousness of the events was assessed as non-serious by reporter. The outcome of the events was resolving. Follow-up attempts have been completed and no further information is expected. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
52 2021-05-31 pain in extremity Pain up and down back, arm at time of injection. Lasted rest of day. Next day arm still hurt and the... Read more
Pain up and down back, arm at time of injection. Lasted rest of day. Next day arm still hurt and then concentrated in arm pit, was sore to the touch and had a lump for a week.
52 2021-05-31 pain in extremity Shot was Friday 28May21 12:50 pm. I awoke Saturday with a sore arm, armpit and left ribcage into bre... Read more
Shot was Friday 28May21 12:50 pm. I awoke Saturday with a sore arm, armpit and left ribcage into breast. By night fall, it became Inflamed lymph nodes in armpit with slight swelling in left breast. This lasted throught Monday night. I also had a tender right armpit on Monday. A severe ocipital headache accompined this. I did a hot soak in the bath with epsom salt on Sunday. I took ibuprofen and excederine migrane for the headache and inflamation, along with hot and cold compresses, primaraly hot. Inflamaiton is almost gone, but still tender today, Tuesday 01Jun21. I notified my Doctor today. Side note, it is possible that I had an undiagnosed case of Covid-19 last February-March 2020.
52 2021-05-31 tremor, tingling First shot was 2/16/21. Also had Pfizer Lot # EN6206 on 3/9/21 I didn't really have any symptoms wi... Read more
First shot was 2/16/21. Also had Pfizer Lot # EN6206 on 3/9/21 I didn't really have any symptoms with the first dose except mild soreness in arm. I had mild dizziness right after the 2nd dose for about 10 minutes and then the next day I had chills, fatigue and aches. But I started having weird symptoms a few weeks after the 2nd dose and I'm not sure if any of all of them are due to the vaccine. First I started having achy knees and some other joints about 2-3 weeks later. It is only a problem once in a while and presents in my left knee, my fingers, wrists, feet and shoulders. Then on May 1st I had a vmild case of what has now become more common and severe. I got tingly feet and became very thirsty. Then on May 23rd I went to the Emergency Room because my feet, hands and mouth/tongue became tingly. After about 20 minutes I became shaky. I was also very thirsty, so thirsty that after about 6 glasses of water I was still thirsty. We thought it was blood sugar issues, but my blood sugar was only slightly elevated and not enough to cause the symptoms I had. I was having fun with my family watching a movie when it started. Then on May 28th it happened again. I went to the school nurse with tingling, dizziness and thirst.
52 2021-06-01 muscle spasms, pain in extremity In the evening about 7 or 7:30 my arm was sore from the injection and a little better in the evening... Read more
In the evening about 7 or 7:30 my arm was sore from the injection and a little better in the evening it started to travel up my neck and it was hard to move my arms and shoulders. The next morning because of the soreness in my neck, I am not sure if it was my neck was sore from the pain radiating from my arm, but my neck was very painful to move it. My neck felt like it could not freely move it, I wasn't able to move it in normal ranges. I had x-rays taken of my neck, the provider felt like it was from muscle spasms from after having the vaccine. I went the physical therapy and they taught me exercises to relieve the pain. I feel like it has slowly been getting better.
52 2021-06-01 pain in extremity right upper arm was really sore; my stomach, all around to my back, all on the right side was really... Read more
right upper arm was really sore; my stomach, all around to my back, all on the right side was really sore, to the point where it hurt to walk; my stomach, all around to my back, all on the right side was really sore, to the point where it hurt to walk; my stomach, all around to my back, all on the right side was really sore, to the point where it hurt to walk; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old non-pregnant female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Batch/Lot Number: EN6202), via an unspecified route of administration, administered on Arm Right on 26Feb2021 11:30 (age at vaccination: 52 years) at single for covid-19 immunisation. The patient medical history included COPD/Asthma and had allergies(drug hypersensitivity) to Floxin that is used in antibotics. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. Medical history included chronic obstructive pulmonary disease. Concomitant medications in two weeks included apixaban (ELIQUIS), levothyroxine sodium (SYNTHROID) taken for an unspecified indication. On 27Feb2021 04:00 ,the patient experienced, right upper arm was really sore which was to be expected, but my stomach, all around to my back, all on the right side was really sore, to the point where it hurt to walk and still pretty sore and it has been 4 days now. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
52 2021-06-03 inability to speak lost a lot of weight; agitated; unable to control her blood sugar with insulin/fore I went to bed it... Read more
lost a lot of weight; agitated; unable to control her blood sugar with insulin/fore I went to bed it was 168. Now I'm waking up with 390-490; headache; dizzy; pressure went up; trouble speaking; cannot walk fast; had tests and I was 5.9, now almost 15 (did not specify which test, but probably referring to HbA1c); trouble breathing/shortness of breath; feels like something is on her chest like her heart is going to stop; feels like something is on her chest like her heart is going to stop; This is a spontaneous report from a contactable consumer (the patient). A 52-year-old female patient, dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included open heart surgery in 2010 and since then I have taken care of myself and I have had no problems anymore, heart problems the doctor said I have cardiac rheumatism from an unknown date and unknown if ongoing, covid-19 from 24Apr2020 to an unknown date she had Covid on 24Apr2020 and she spent 15 days in the hospital and was left at home with oxygen for one month. She came back negative. When she had Covid was 209 and she has lost 30 pounds. Clarified that she lost weight before the vaccine and she lost weight and was at 186. Historical vaccine included received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Apr2021 09:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE and her blood sugar spiked/blood sugar went up. The patient's concomitant medications were not reported. The patient experienced trouble breathing/shortness of breath and feels like something is on her chest, like pain but not exactly, like her heart is going to stop in Apr2021, unable to control her blood sugar with insulin/fore I went to bed it was 168. now I'm waking up with 390-490 on 03May2021, headache in Apr2021, dizzy in Apr2021, pressure went up in Apr2021, trouble speaking in Apr2021, cannot walk fast in Apr2021 and had tests and I was 5.9, now almost 15 (did not specify which test, but probably referring to hba1c) in Apr2021. Her levels are 490-500. She is on a really strict diet and has lost a lot of weight. Stated that she woke up today at 490 and ate one boiled egg and one tea and one simple cookie and two hours later was up to 514. Stated that it is still increasing and at this pace she will get at diabetic coma. Stated she gets her insulin through a pump and it is not helping her or lowering it. Stated that she woke up on 06May with it at 239 and kept it like that until she ate lunch and it increased to 320. Stated that they changed her insulin and she is taking two insulins. Stated that she took Humalog and Basaglar last night. Stated that she got dizzy with the second shot and her pressure went up. After the second dose my blood sugar also increased, but now insulin didn't help me. Usually I have half a bottle of insulin left, but now I finished 4 bottles and I don't have any more. In Mar2021 I had a glucose test and I was fine. On 24Apr2021 I received the second dose, on the 23May2021 I woke up with my glucose on 111, before I went to bed it was 168. Now I'm waking up with 390-490, even though I don't eat all day and it stays high. Last year I had Covid and now I feel agitated like when I had Covid, but I took a test and it came back negative. The patient underwent lab tests and procedures which included blood glucose: 390-490 on Apr2021 I'm waking up with 390-490, even though I don't eat all day and it stays high, blood glucose: 111 on 23Apr2021 on the 23rd I woke up with my glucose on 111 , blood glucose: 168 on 23Apr2021 before I went to bed it was 168 , glucose tolerance test: fine in Mar2021 March I had a glucose test and I was fine, glycosylated haemoglobin: 15 in Apr2021 I had tests and I was 5.9, now almost 15, sars-cov-2 test: negative, sars-cov-2 test: positive in 2020. The event blood sugar spiked was reported as worsened. The outcome of breathing/shortness of breath and feels like something is on her chest like her heart is going to stop, headache, dizzy, pressure went up, trouble speaking, cannot walk fast and tests and I was 5.9, now almost 15 (did not specify which test, but probably referring to hba1c), weight loss and agitated was unknown and not recovered for unable to control her blood sugar. Information about Lot/Batch number has been requested.
52 2021-06-03 feeling hot I felt dizzy; arm for itchy; now it's all red; now it's all hot; now it's all swollen.; This is a s... Read more
I felt dizzy; arm for itchy; now it's all red; now it's all hot; now it's all swollen.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number= Unknown) via an unspecified route of administration on 17Feb2021 at 18:00 in left arm as single dose for COVID-19 immunization. Patient had no known allergies. Patient had no other medical history. Other medications (concomitant) in two weeks included estrogen and progesterone. Patient did not receive any other vaccine within four weeks of suspect vaccine. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. On 06Mar2021 at 12:00 PM, 16 days and 18 hours after first dose of vaccine, patient felt dizzy, arm for itchy and now it's all red, hot and swollen. Patient did not receive any treatment for the events. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
52 2021-06-03 grand mal seizure Patient's mother reported that she had a grand mal seizure about 2 hours after receiving her vaccina... Read more
Patient's mother reported that she had a grand mal seizure about 2 hours after receiving her vaccination. Patient has poorly-controlled epilepsy.
52 2021-06-04 pain in extremity I have been in menopause state haven't had a period in over 1yr. 2 days after the first dose of the ... Read more
I have been in menopause state haven't had a period in over 1yr. 2 days after the first dose of the covide19 shot I got my period; headache; dizzy; nauseous feeling; arm pain; 2 days after the first dose of the covid-19 shot got her period; This is a spontaneous report from a non-contactable consumer (patient) .A 52-year-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 04Mar2021 (at the age of 52 years old) at a single dose for COVID-19 immunisation. The patient medical history included High Cholesterol and Statins allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient received historical vaccine Shingrix on 05Feb2021 in two weeks of vaccination. Concomitant medications included Celecoxib (CELEBREX), fish oil, Colecalciferol (VITAMINE D), Zinc, Probiotics. On 06Mar2021 the patient stated not some much as a reaction but have been in menopause state haven't had a period in over 1yr. 2 days after the first dose of the covid-19 shot got her period. The shot did cause headache, dizzy, nauseous feeling, arm pain as well for about 2 days so far. No treatment was received. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
52 2021-06-05 numbness, tingling Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial a... Read more
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient received shot, waited 15 minutes, felt fine and left store. She called about an hour later (3:05pm) asking about tingling that she was experiencing on the side of her body that got the shot (arm, hand, leg) -I believe it was left side. Also a numbness on her mouth/lips. I advised pt to contact her primary which advised pt to go to urgent care. At urgent care she was seen and her symptoms subsided. I called pt at 8:45pm she stated that she was feeling better, but lip was still numb.
52 2021-06-06 numbness 22nd- left eye twitch, 23rd- eye twitch plus cheek numbness, 24th- same with numbness into forehead,... Read more
22nd- left eye twitch, 23rd- eye twitch plus cheek numbness, 24th- same with numbness into forehead, 25th- same with numbness into neck, 26th- same with numbness of left arm (elbow to fingers). ER visit on 26th. Diagnosed as mini stroke.
52 2021-06-06 tenderness Lip swelling with tenderness for a week
52 2021-06-06 tremor About 24hrs after receiving the vaccine. I had body aches, shaking fever and headaches.
52 2021-06-07 weakness This is a spontaneous report from a contactable consumer or other non-Health Care Professional (Pati... Read more
This is a spontaneous report from a contactable consumer or other non-Health Care Professional (Patient). A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number and Expiration date was not provided) via an unspecified route of administration in Arm Left on 05Mar2021 at 14:00 (at the age of vaccination 52-years-old) as 2 ND DOSE, SINGLE for COVID-19 immunization at Public Health Clinic/Veterans. The patient medical history included type 1 diabetes mellitus. The patient had known allergies to Tetracycline. The patient received medications within 2 weeks of vaccination included insulin (INSULIN). The patient previously took tetracycline and experienced drug hypersensitivity and the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, in Left arm on 12Feb2021 at 02:30 PM as single dose for COVID-19 immunization. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 06Mar2021 at 12:00 AM, the patient had experienced fever of 102, fatigue, muscle pain and weakness. The patient underwent lab tests and procedures which included body temperature: 102. The seriousness of the event was reported as non-serious. The clinical outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.
52 2021-06-07 numbness Approximately 22-24 hours after receiving the shot I developed upper abdominal pain and exhaustion.... Read more
Approximately 22-24 hours after receiving the shot I developed upper abdominal pain and exhaustion. The pain continued to get worse over the next several days. I then developed chest pain and ended up in the emergency room. It has now been 2 weeks since the day I got the vaccine and I am still not better. The doctor thinks the chest pain was my esophagus having a spasm. I have had an EKG, an ultrasound, extensive blood work, a rectal exam, a blow test and 2 exams and I still do not have a definitive answer as to what is wrong with me. I missed several days of work. I also have Vertigo since getting the vaccine, although this is something I?ve experienced before. I also had an increase in heart palpitations and on Sunday I developed palpitations that I could not get to stop for quite some time, and then my face started to go numb as well as my feet and arms. This lasted about 5 minutes. It was very scary and I do not know what was going on with that. As of today I am mainly just dealing with the upper abdominal pain. I am taking a prescription medication that I started yesterday for acid relief but so far it?s not helping. I will not be getting the second dose. I was healthy with no issues before the vaccine. I am confident this is a result of how my body reacted to the vaccine.
52 2021-06-07 tingling, pain in extremity Blurred vision; Thyroid inflamed; tingling all through out the whole body; blue hands/Black and blue... Read more
Blurred vision; Thyroid inflamed; tingling all through out the whole body; blue hands/Black and blue mark swollen on calfs; Pain in right leg; Black and blue mark swollen on calfs; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unspecified date (at the age of 52-years-old) (Batch/Lot Number: 648543) as single dose for covid-19 immunisation. Medical history included hashimotos. Concomitant medications included ergocalciferol (VITAMIN D); cyanocobalamin (VITAMIN B12) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was no pregnancy. The patient was no pregnancy at time of vaccination. Age at vaccination was 52 years. The patient experienced blurred vision, thyroid inflamed, tingling all through out the whole body, blue hands, pain in right leg and black and blue mark swollen on calfs on 15Apr2021. The events resulted in emergency room/department or urgent care. The patient was hospitalized for the events for 1 day. The report was serious with the seriousness criteria of hospitalization. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
52 2021-06-07 tingling itchiness body wide; headache; tingling in mouth and face; tingling in mouth and face; swollen face;... Read more
itchiness body wide; headache; tingling in mouth and face; tingling in mouth and face; swollen face; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Mar2021 13:00 (Lot Number: EN6207) (at the age of 52-years-old) as 1st Dose, single dose for covid-19 immunization. Medical history included PFO/ASD (Atrial Septic Defect) , TIA (transient ischaemic attack), asthma, high BP (blood pressure), diabetic and obesity. Patient has known allergies in cinnamon, cloves, allspice, adhesives, mold and pollens. The patient was not pregnant and did not have COVID prior to vaccination. Concomitant medications included BP medication, zolpidem and cholesterol medication. The patient did not receive other vaccine in four weeks. The patient experienced itchiness body wide, headache, tingling in mouth and face and swollen face even after taking 2 BENADRYL on 09Mar2021 at 13:15. The patient was not tested for COVID post vaccination. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
52 2021-06-08 feeling of insects crawling on skin, tingling, nerve pain first dose lot #ER2613 received on 3/23/2021 nerve sensitivity, pain, tingling, crawling sensation i... Read more
first dose lot #ER2613 received on 3/23/2021 nerve sensitivity, pain, tingling, crawling sensation in shot arm. Lasted 3 days. Mentioned it to nurse prior to second dose. Second shot nerve sensitivity, pain, tingling, crawling sensation, pins and needles started in shot arm that evening of shot next day moved between arms, hands, face, legs and feet. severity has lessened but has not gone away and there is always some low level sensation of it somewhere all of the time.
52 2021-06-08 pain in extremity Very inflamed under neck; Severe rash/rash started up around my neck and spreading/rash took over ne... Read more
Very inflamed under neck; Severe rash/rash started up around my neck and spreading/rash took over neck and chest; front and back; severe pain in left hand; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FSA RX 0884468; Expiration date was not reported) on the left arm on 19May2021 (16:30) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. The patient had no relevant medical history. Concomitant medication included ibuprofen (ADVIL 12 HOUR). The patient was not pregnant at the time of vaccination. On 20May2021, the patient had severe pain in the left hand. On 21May2021, the patient had severe rash; the rash started up around the neck and spreading. On 22May2021, the patient's rash took over the neck and chest, front and back; and the patient was very inflamed under the neck. The patient had received diphenhydramine (BENADRYL) and ibuprofen (ADVIL) as treatment for the events. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
52 2021-06-08 pain in extremity First dose soreness in arm (left); This is a spontaneous report from a contactable consumer reportin... Read more
First dose soreness in arm (left); This is a spontaneous report from a contactable consumer reporting for herself. A 52-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318, expiration date not reported), via an unspecified route of administration, in Arm Left on an unknown date in Feb2021 (01:00 PM, as reported) (at the age of 52-years-old), as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, known allergies to sulfa. Concomitant medications included lisinopril; elderberry [sambucus nigra]; vitamin D NOS; ascorbic acid (VIT C). Patient did not receive other vaccines in four weeks of Covid vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On unknown date in Feb2021, the patient experienced first dose soreness in arm (left). Patient did not received treatment for adverse event. Outcome of the event was recovered approximately on unknown date in 2021 (that lasted more than two weeks, as reported). No follow-up attempts are possible. No further information is expected.
52 2021-06-09 tingling arm is sore at injection area. More concerning I woke up before 5 AM heart was pounding and the left... Read more
arm is sore at injection area. More concerning I woke up before 5 AM heart was pounding and the left side of my face was swollen and my left I was hooded and almost shut, all subsided around 11 AM My lymph nodes in my left arm pit and outside of breast and inside rib cage started tingling swelling about an hour after shot , and left forearms feel tight today. Today is day 2 and left and right lymphnodes are sore in arm pits and joint pain in ankles and elbows,
52 2021-06-10 numbness Numbness in the face; This is a spontaneous report from a contactable consumer (patient). A 52-year-... Read more
Numbness in the face; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 13Mar2021 at 00:15 (reported as 12:15 AM) (at the age of 52 years old) as first dose, single for COVID-19 immunisation in a Public Health Clinic/Veterans Administration facility. Patient has known allergies with Penicillin from an unknown date. The patient was not pregnant at the time of vaccination and prior to vaccine the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines in 4 weeks prior to the COVID vaccine and has no list of any other medications received within 2 weeks of vaccination. The patient experienced numbness in the face on 13Mar2021 at 12:45 (reported as 12:45 PM). No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained
52 2021-06-10 migraine Migraines; Sensitivity to sound; Higher blood pressure; Sensitivity to light; This is a spontaneous ... Read more
Migraines; Sensitivity to sound; Higher blood pressure; Sensitivity to light; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), first dose on 25Mar2021 08:00 (Lot number: EP7534) and second dose on 15Apr2021 (Lot number: ER8737) both via an unspecified route of administration, administered in right arm as single dose for COVID-19 immunisation. Medical history included RSV (respiratory syncytial virus) autoimmune. No Prior Vaccinations (within 4 weeks). Concomitant medications included ongoing lisinopril (Has been taking for years). It was reported that she was still dealing with migraines and everything else, and light sensitivity. Migraines started the day after the second dose on 16Apr2021, and she had it for 6 days straight. It settled some, enough for her to think straight. It was back again yesterday and was full fledge today. Has had to wear sunglasses ever since. Treatment: Imitrex and some Toradol. She had higher blood pressure in the beginning when she got the first shot in 2021. They gave her another blood pressure medication, stated that the blood pressure was better now. Sensitivity to light it was explained that this was lasting longer than the migraines; she was back in sunglasses due to this in 2021. She also has some sound sensitivity but that was part of the migraines. She has had this going on since the migraines started in Apr2021. Due to migraines patient visited Emergency Room the other month when this first started, in Apr2021. Was not admitted to the hospital. Was on 12 different medications in the previous year. Clarified that she was not on any other medications within 2 weeks prior to the Covid 19 vaccine. The outcome of event migraine was not recovered, blood pressure high was recovering, remaining events were unknown. Information on Lot/Batch number was available. Additional information has been requested.
52 2021-06-10 pain in extremity Serious arm pain that radiated to hand and across my back with inflamed lymph nodes on left side of ... Read more
Serious arm pain that radiated to hand and across my back with inflamed lymph nodes on left side of my body. Inflammation of lymph nodes lasted for 2 weeks arm pain continues almost 3 months later.
52 2021-06-10 pain in extremity Headache; Arm was a little sore; Low-grade temperature; This is a spontaneous report from a contacta... Read more
Headache; Arm was a little sore; Low-grade temperature; This is a spontaneous report from a contactable consumer reported for herself. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration in left arm on 08May2021 08:00 (Batch/Lot Number: ER8736) as a single dose for covid-19 immunisation at School or Student Health Clinic. Medical history included congestive cardiac failure, coronary artery disease, hypertension, asthma, migraines, narcolepsy, bipolar disorder, sleep apnoea, gastrooesophageal reflux disease, low potassium, low iron, tomatoes allergy, dust allergy, pollen allergy, grass allergy, ragweed allergy, allergy to medications included morphine allergy and ceclor allergy. Concomitant medications included carvedilol (COREG), clopidogrel bisulfate (PLAVIX), omega-3-acid ethyl ester (LOVAZA), bepotastine besilate (POTAS), furosemide (LASIX [FUROSEMIDE]), atorvastatin calcium and ezetimibe (STATIN EZ).The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been been tested for COVID-19. The patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 05Jun2021 09:45 (Batch/Lot Number: EW0179) as a single dose for covid-19 immunisation.On 08May2021, 08:00 after administration of first dose of vaccine the patient experienced arm was a little sore, low grade temperature and headache too for some days. Clinical course was reported as on the first shot my arm was a little sore, I got a low-grade temperature and a headache too for a few days. However, with all of my allergies to medication, etc this vaccine did not bother me at all in that regard.The patient underwent lab tests and procedures which included body temperature was low. There was no treatment given for the reported events. Outcome of the events arm was a little sore, low grade temperature and headache was recovered on an unspecified date in 2021..
52 2021-06-10 pain in extremity Feet started to hurt, she couldn't put weight on her feet and they were turning black; Legs and feet... Read more
Feet started to hurt, she couldn't put weight on her feet and they were turning black; Legs and feet were hurting so bad; Legs and feet were hurting so bad; She couldn't put weight on her feet and they were turning black; She couldn't put weight on her feet and they were turning black; Legs and feet were starting to swell; Legs and feet were starting to swell; Her hands were black; Hands were starting to swell up; This is a spontaneous report from a contactable consumer (the patient). A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 17:00 (Lot Number: EW0151), at the age of 52 years, as a single dose for COVID-19 immunisation. Medical history included crohn's disease (Crohn's disease Diagnosed at age 25), thyroid disorder (thyroid Diagnosed in her 30's). Concomitant medication taken within two weeks of vaccination included vitamin b12, zinc, potassium, tocopheryl acetate (E-VITAMIN), cyanocobalamin (B12), and vitamin b complex (VITAMIN B), all taken for crohn's disease; levothyroxine taken for thyroid disorder, dicycloverine (DICYCLOMINE) taken for abdominal pain, and omeprazole (PRILOSEC). The patient experienced feet started to hurt, she couldn't put weight on her feet and they were turning black on 10Apr2021, hands were starting to swell up on 07Apr2021, her hands were black on 08Apr2021, legs and feet were starting to swell on 09Apr2021, legs and feet were hurting so bad on 10Apr2021. She couldn't put weight on her feet and they were turning black on 10Apr2021. The patient was hospitalized for feet started to hurt, she couldn't put weight on her feet and they were turning black on 10Apr2021. The patient received treatment. The verbatim clinical course was reporter as follows: The patient is calling about the Pfizer covid vaccine. The patient had the first dose on 07Apr2021. By 10Apr2021 the patient was in the hospital, they thought at first the patient had blood clots. The patient is still not back to work yet. They keep having the patient have tests done. The patients hands and feet turned black and were swollen up after she received the vaccine. The patient got the vaccine at 5:00pm on 07Apr2021, and that night her hands were starting to swell up. The patient thought it was because of her Crohns. Then the vessels in the patients fingers started busting, is what it looked like, and her hands were black and she couldn't hardly move them on 08Apr2021. Then the next day, 09Apr2021, the patient noticed her legs and feet were starting to swell. The next day, 10Apr2021, the patient was starting to look down and her legs and feet were hurting so bad she had to sit down when she was vacuuming. The patient thought she stepped on the vacuum cord when her feet started to hurt, she couldn't put weight on her feet and they were turning black. The patient propped her legs up and then soaked them in Epson salt and hot water and that made them worse. The patient went to healthcare facility on10Apr2021 and they said it looks like she has blood clots so they sent her to emergency room. In the emergency room they admitted the patient and did test after test. They gave the patient morphine for the pain that was shooting down her legs, it felt like needles were sticking in her legs. The patient was out of it for a couple of days because when she got that morphine she didn't know she was in the world. Morphine- unknown lot, NDC , and expiration dates for doses involved. They gave the patient gabapentin and that helped some. They were giving the patient so much Gabapentin during the day she couldn't function so they cut it back to giving it to at night. The patient was taking the Gabapentin 3 times a day, at the time, and she couldn't function on it. Gabapentin- unknown lot, NDC, and expiration date for the doses given in the hospital. The night of 07Apr2021 the patient couldn't really move her fingers and took it easy. 09Apr2021 is when this started in her feet. Then on 10Apr2021 the patient went to the hospital because the pain was so bad. By the end of the day the patient is still swollen. One leg was swollen more than the other but they are not black and blue like they were and they said its from nerve damage. The patient was so drugged up in the hospital, she didn't know her name. The patient has an EMG test scheduled on 04Jun2021. The patient was scheduled for the second shot on 28Apr2021 and didn't get it because she was told not to by her doctor and the hospital doctors. Test in the hospital was as follows: 10Apr2021: US venous leg bilateral, chest x-ray with one vw portable, CBC with differential, CMP, d-dimer, EFR, INR, active particle thromboplastin time, EKG. On 11Apr2021: TSH, TR3, CK, Magnesium, sars-cov-2antigenfia with reflux to covid rapid test- negative, aorta angiogram runoff with contrast, x-ray of the foot lateral and oblique. On 12Apr2021: Magnesium, CBC, BMP, ANA, ANA titer. On 13Apr2021: CBC,BMP, and a urinalysis with reflex. On 19May2021: MRI lumbar and spine with and without contrast was ordered by the neurologist. The patient reported that she thought that the hospital reported this so she went back to her paperwork and called today to report this event. The clinical outcome of She couldn't put weight on her feet and they were turning black, Legs and feet were hurting so bad, and Legs and feet were starting to swell was unknown. The patient was recovering from the remaining events. Additional information has been requested.
52 2021-06-11 numbness, pain in extremity, burning sensation Initially, all I felt was extreme pain in my left arm. I was advised by the medical staff that my re... Read more
Initially, all I felt was extreme pain in my left arm. I was advised by the medical staff that my reaction was normal. During the middle of the night, my left arm felt as if it was burning. It woke me up out of my sleep. From the injection site down mid-elbow, my arm was filled with hives & welts and it was extremely itchy. The arm also felt as if it was on fire. I applied some Benadryl ointment on my arm and tried to go back to sleep. When I got up, both of my legs felt extremely numb. I felt as if I was walking on air. I attempted to walk around and fell in the street because I was not able to feel my legs. The numbness remained for the balance of the day. I stayed in bed because I injured myself quite a bit. Every time I tried to move around, I felt as if I was walking on air and was not in a position to stabilize myself. This numbness feeling did not subside until Sunday evening, as well as the issue with my arm.
52 2021-06-12 cold sweat, tingling Anxious clammy skin, arms tingling - prolonged symptoms x35 minutes - Benadryl dosed @20 minutes po... Read more
Anxious clammy skin, arms tingling - prolonged symptoms x35 minutes - Benadryl dosed @20 minutes post vaccine.
52 2021-06-13 tremor, weakness Within 24 hours, I had a splitting headache and body pains ( especially neck and feet)/weakness. I b... Read more
Within 24 hours, I had a splitting headache and body pains ( especially neck and feet)/weakness. I broke out into a full body rash. After 24 hours, headache relieved and left an Arora. I am now 7 weeks out and am still having dizziness and occasional headaches as rashes that come and go. Recently, I?ve experienced weakness in my legs, inside trembling and heart racing episodes. I have NOT had one day since the 2 Nd vaccine without dizziness. I?ve also had cold symptoms and ear issues. In two day, I?ll be at my 8 week mark since second dose. I?m living on the sofa, miserable and basically, housebound.
52 2021-06-14 flushing pt experienced lightheadedness, flushing and trouble breathing. The pt was walking around the store ... Read more
pt experienced lightheadedness, flushing and trouble breathing. The pt was walking around the store during her 15 minutes of observation and decided to walk to her car once symptoms became present. She did not report back to the pharmacy. No treatment was given ans the pharmacy was told about the reaction 4 days after it was given
52 2021-06-14 muscle spasms reports severe pain in mouth, reports muscle spasms on right side of body, pain/spasms severe enough... Read more
reports severe pain in mouth, reports muscle spasms on right side of body, pain/spasms severe enough to require medication, patient is contacting her MD
52 2021-06-14 night sweats I thought I was vaccinated, I am a flight attendant. I felt sick when I landed. On Tuesday I was in... Read more
I thought I was vaccinated, I am a flight attendant. I felt sick when I landed. On Tuesday I was in I woke up really sweaty and had night sweats. While flying i had diarrhea and felt really sick. I didn't think I had Covid since I was vaccination. I continued to work spreading Covid and on Tuesday morning I had a cold. On Wednesday night I had breathing difficulty, got myself vomiting, was vomiting foam. I went to ER where they did a Covid test. I was told I had Covid. They put me prednisone, prescribed a z-pack. I then had diarrhea, difficulty breathing and I am so angry because I got really sick. It was coughing for an entire dark dog cough for a whole month. I also took Mucinex severe cough syrup which helped me get my symptoms down. At this time, I feel like I am recovered. On may 10,2021 I stopped coughing.
52 2021-06-14 pain in extremity, weakness Had a low-grade fever 99. Sore in my left arm. I also had body ache. On the second day, I wake up ... Read more
Had a low-grade fever 99. Sore in my left arm. I also had body ache. On the second day, I wake up with both shoulder pain and had a fever. I felt very weak. My whole body ached. I also had a running nose and was sneezing a lot. I felt litharge and really tired. I had a doctor phone appointment. Then I feel asleep.
52 2021-06-15 pain in extremity Pt presented to pharmacy for a covid shot and received a dose of pfizer on 6/12/21. Later in the day... Read more
Pt presented to pharmacy for a covid shot and received a dose of pfizer on 6/12/21. Later in the day the pharmacist that administered shot realized that the patient had received a dose of moderna on 5/11/21. She called the patient to discuss the situation and to let us know of any potential side effects. Tonight 6/16/21 the patient calls the pharmacy and i discuss the situation with her. She said she started having severe body/bone/muscle aches on the afternoon of the pfizer shot which was 6/12. She said she knew that was somewhat normal but on 6/13 the body aches were worse and she started having swelling in her face and couldn't get her legs to work walking up two stairs without assistance. She started taking benadryl "around the clock". On 6/14 she said her symptoms were mostly unchanged, still having swelling in face and legs/arms hurting. On 6/15 she "blacked out" meaning she was sleeping and woke up and when she went to stand up her legs collapsed and she slid off the bed but she said she didn't hit her head. She said that happened two different times on 6/15. Today, 6/16 she called the pharmacy because her lips were the most swollen and sore they have been and it hurt to drink cold water and was hard to talk. She said she had to use her inhaler that morning because her chest was a little tight but she wasnt having any trouble breathing and her throat was fine. She said her face was still swollen and she looked like she'd been punched in the mouth. I counseled her to seek medical help asap since she was having trouble walking and the falling down and the face swelling hadn't gone away and she said she didn't want to go to the ER but would call her dr on the am of 6/17/21. I told her if anything changed she needed to go to ER or call 911. No other info at this time. 8:40 pm 6/16/21
52 2021-06-15 tingling, feeling jittery The side effects I still have to this day are tingling in my left arm (it comes and goes but it is d... Read more
The side effects I still have to this day are tingling in my left arm (it comes and goes but it is daily) and tinnitus. I remember the tingling started a few days after the shot and I've had every day since, Tinnitus about the same. I also have on and off loose bowels -- still. My diet and physical activity have been about the same long before and after I had the second shot, but my digestive system has been different. I'll note the other side effects I had that went away -- just so you have all the information. 12 hours after I had the second shot I suddenly felt jittery and had a fever of 100.7. It was late so I took tylenol and went to bed. Woke up feeling fine. Was a little achy and tired later in the morning. I took tylenol and after that wore off I felt completely fine. I also have felt I've had on and off brain fog. I can have that anyway but I would say it felt the worst 2 weeks ago. Even though my ongoing side effects are not severe, it seems odd that I still have them over a month later so I thought I should report them.
52 2021-06-16 weakness had a little bit of weakness; feeling a little icky; This is a spontaneous report from a contactable... Read more
had a little bit of weakness; feeling a little icky; This is a spontaneous report from a contactable consumer or other non hcp via medical information team. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 15:00 (Batch/Lot Number: EW0185) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not had any prior vaccination. The patient experienced had a little bit of weakness and feeling a little icky on an unspecified date in 2021. It was reported that 19May2021 was patients first dose and patient only had a little bit of weakness and feeling a little icky but then it went away. Patient was taking Pfizer BioNTech Covid-19 Vaccine because lots of people died without it. She figured she needed to get it. Caller stated that she took the Pfizer first shot. She took it and had no serious reaction right after the needle was taken out of her arm. Later she felt weak. It went away. She knew this was common. Caller stated that she hadn't weighed herself in awhile. She thought she was about 230 pounds. Caller mentioned she was expecting that to feel weak. She later went on to explain about feeling a little weak. It stated that she felt weak a day or two after the shot. It lasted for a week. It went away to her feeling normal. The outcome of event was recovered on an unspecified date in 2021. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684035 same patient/drug, different dose/event
52 2021-06-16 feeling hot When I went to get the vaccine, it was already drawn from the vial. The vial placed on the table was... Read more
When I went to get the vaccine, it was already drawn from the vial. The vial placed on the table was Moderna. I am not sure which vaccine I received; confused; a slightly elevated temperature which went from 99. to 100.2; Her ears were also red/Her ears are burning red; her whole face is red, ears are red, neck is starting to get red and front of chest is red; chest was purple; She felt hot; a rash all over her body/rash around the head and chest/She got a huge rash on her face, neck, and chest, forehead, cheeks, and nose; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0217, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 04Jun2021 around 15:30 or 15:45 pm (age at vaccination was 52 years) as 1st dose, single dose for COVID-19 immunization. The patient medical history included elevated blood pressure. The caller stated that she was diagnosed with elevated blood pressure in February or March this year. Stated her blood pressures was 138 or 140's or something like that. 148/90 or over 88. Sometimes it was 139. Concomitant medications included amlodipine with dose 5 mg 1x/day via oral route for elevated blood pressure. The patient took the Pfizer COVID vaccine because everyone required it. The patient experienced a rash all over her body and wanted to know if that was vaccine side effect or she needs to contact her HCP. On PRD 04Jun2021, it was reported that the caller wanted to know the expiry date and confirm the product under the lot number provided. She received the response stating that confirmed the product was a Pfizer COVID-19 vaccine. They also provided the expiration date: 30Sep2021. The caller had gone to the pharmacy to receive a COVID-19 vaccine. All her friends had received the Pfizer COVID-19 vaccine. Moderna caused many side effects. Her doctor also said it's belter she gets the Pfizer COVID-19 vaccine because she had elevated blood pressure. When she went to get the vaccine, it was already drawn from the vial. The vial placed on the table was Moderna. She was not sure which vaccine she received. The lady who gave her the vaccine told her it was the Pfizer COVID-19 vaccine. She can't trust them because the vaccine was not drawn from the vial in front of her. She had called the pharmacy three times already. They have been giving her different information each time. First, they said they don't have the Pfizer COVID-19 vaccine and then they said they do. She asked that why doesn't Pfizer create a policy to ensure that the vaccine should be drawn from the vial in front of the patient. She was not sure what they gave. They may be made her part of a study. She was very confused. There were two syringes filled in. She was not sure which vaccine did she receive. The caller reported rash around the head and chest right after receiving the vaccine. She also noticed few minutes post vaccination a slightly elevated temperature which went from 99. to 100.2. Her ears were also red. She received the response stating that they cannot verify which vaccine she had received as they had not witnessed the administration. Fever and rash had been reported with the Pfizer COVID-19 vaccine. The reaction could occur anywhere from minutes to a few days post vaccination. A reaction such as ears turning red has not been listed as side effect in the prescribing information. They didn't have the list of all the possible side effects associated with the vaccine. The asked her to speak to her HCP if the symptoms persist or didn't go away. Informed caller to contact someone at the pharmacy and report the event. Pfizer cannot control the policy and procedure of the pharmacy. It's best to report to ensure they don't repeat such mistakes again. On PRD 04Jun2021, it was reported that the caller called about the Pfizer vaccine EW0217. Caller stated she just got the vaccine at and the pharmacy refused to let her see the vial it was drawn out of. The guy had a bottle that said Moderna and wouldn't let her go to the back. When she asked to see the Pfizer covid vaccine vial they told her they threw it out. She asked that why was the pharmacy refusing to let her see what they were giving her. She stated she honestly thought they did something but told her that they drew it in the back. She asked how she was supposed to know she got the Pfizer covid vaccine. She was told she was to get her second dose in 4 weeks, and the caller questioned 4 weeks stating the Pfizer second dose should be 3 weeks after first dose. Then stated getting the second dose 4 weeks after first dose was for Moderna, not Pfizer. She just got the vaccine. She reported her whole face was red, ears were red, neck started to get red and had a huge rash on the front of her chest. She got a huge rash on her face, neck, and chest, forehead, cheeks, and nose, it was all red. She didn't know if it was going to get worse. Her ears were burning red. Received vaccine half hour ago about 2:45. Her card did not say anything about the date of when she should get the second dose. She did not receive any treatment as it just happened half hour ago. She stated her ears were burning and were purple, red. She had never had purple ears before. The caller wanted to know if that was normal and whether she should go to her doctor's office because it was Friday. There was a Product complaint. The description of complaint included the caller received COVID-19 Vaccine Lot# EW0217. Caller was concerned she did not receive the Pfizer COVID vaccine. Vaccine facility refused to show her the vial stating it was discarded. Product strength and count size dispensed was not provided. No sample of the product was available to be returned as the vial was discarded. Packaging sealed and intact was not provided. On PRD 04Jun2021, it was reported that the caller just received the Pfizer Covid-19 Vaccine. She had a huge rash on her head and chest. Her ears are red. The caller had really called because she didn't like the way of administering the vaccine. The caller saw a Moderna vial on the table where she was vaccinated. She wanted to see the vial to the vaccine that she received. Did not produce the vial. The caller was concerned that she may have received the Moderna vaccine instead of the Pfizer. The agent also referred caller to the state department of health because they are the ones who distributed the vaccine. The caller stated that she was really not sure if she got the Pfizer vaccine. She believed it was the Moderna or whatever was in that syringe. There were 2 syringes. She didn't know what she was given. When she went to get the vaccine, she walked up to get the paper that had the vaccine information on it. She told them that was not what she wanted. She wanted the vaccine Pfizer made. She told them to provide her with Pfizer's information. She told him to use her right arm. She wanted to see the vial they drew the vaccine from because she saw a Moderna vial on top of the table half filled in. Someone at the pharmacy told the caller they drew up the vaccine in the back. He told the caller she had to trust him. The caller went to the back and asked the lady where the vial was, she drew the vaccine from. The caller stated they did not have the vial they drew her vaccine from but used another vial to show her how the vaccine looks. Caller was told this was the Moderna. They drew it and threw it away. Caller stated how was she supposed to know what they gave her. She simply asked could she see the vial the vaccine was in. The caller stated they gave the vaccine, and she walked out. Caller stated that the pharmacy could have given her a quadruple dose. She didn't see the lady. The lady could have put a random number on there. The caller stated that her ears got really red. Her chest was purple. It was kind of strange. She felt hot. When she got in the car, she looked really red. For the first 5 minutes, it looked like something was growing on her arm. Her face was red. She had to drink water to calm down. The caller confirmed that she told the previous Pfizer safety agent that she had the reaction. The safety agent told her that she should call Medical Information. The caller asked if the side effects were normal whether they really gave her a vaccine. She measured her temperature. Right now, the temperature was 99.3 at 4:15. 3 minutes later it was 99.2. Now it's 100.2. Her head was just hot after an hour and a half. When she checked her forehead it was 99.4. The caller stated shouldn't they have a blue top on the Pfizer vial. He showed her a small vial. He told her it was from the same lot. He asked the lady. The lady drew up the vaccine but said she didn't have it. The lady put the vial in the sharps box. The caller called last week, and they only had Moderna vaccines at that time. Her friend said Pfizer was better and it has less side effects. Caller stated her vaccination card does not say when she has to come back for her second dose. The lady told her to come back in 28 days. Caller knew that they come back in 28 days for the Moderna vaccine. The Pfizer vaccine was 21 days. Caller confirmed she received the first dose of the Pfizer Covid-19 Vaccine today around 2:30 or 2:45. Caller stated that Pfizer provides for guidelines. As a patient, she should see what vial the vaccine was drawn from. She has blood pressure and weight issues. Caller stated she took Amlodipine for blood pressure. Caller stated she hopeed they didn't give her a different kind of vaccine and she turned into a mutant or something. On PRD 04Jun2021, it was reported that the caller was concerned that she might not have been administered the Pfizer COVID 19 vaccine that she had requested. There was a Moderna vial on the table and they couldn't produce the Pfizer vial that my dose came from. She had an adverse reaction to the Pfizer COVID 19 vaccine. She had a huge rash on her face and chest, her ears were red. I received the shot at Walgreens and there was a Moderna vial on the table. She was not sure they gave her Pfizer or if they gave her some kind of experimental drug. They couldn't produce the Pfizer vial that her dose came from. The vaccine card that they gave her said Pfizer on it, but she didn't know that they were from her vial. She took high blood pressure medication. The outcome of the events was unknown. Follow up#01 (04Jun2021), Follow up#02 (04Jun2021), Follow up#03 (04Jun2021) andcFollow up#04 (04Jun2021): New information received from a contactable consumer (patient) reported for herself included: Updated the lot number (EW0217), details regarding the adverse events, concomitant medication (Amlodipine), medical history (elevated blood pressure) and details of product complaint.
52 2021-06-16 hypersensitivity of all senses Hyperesthesia of front surface of left shin (below the knee); Darting pain; This is a spontaneous re... Read more
Hyperesthesia of front surface of left shin (below the knee); Darting pain; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 11May2021 14:00 (Batch/Lot number: 0183) (at the age of 52 years) as 2ND DOSE, 0.3 ML SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. There were no known allergies. There were no other medications in two weeks. Patient was not pregnant at time of vaccination. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 20Apr2021 (Batch/Lot number: WE 0161) (at the age of 52 years) as 1ST DOSE, 0.3 ML SINGLE DOSE for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hyperesthesia of front surface of left shin (below the knee) and darting pain, both on 13May2021 with outcome of not recovered. There was no treatment received for the events. Information on Lot/Batch number was available. Additional information has been requested.
52 2021-06-16 numbness Very painful ejection itself followed by immediate soreness and swelling. Severe soreness and swell... Read more
Very painful ejection itself followed by immediate soreness and swelling. Severe soreness and swelling over a couple of weeks. Once it started to abate I am left with significant immobility in the shoulder. I am unable to sleep on my left side, have weakness in my left arm, and numbness in my left arm and hand. This persists 3 months after the initial injection.
52 2021-06-16 pain in extremity could not sleep; Tightness in chest; Caller states she could not take a deep breath; slight allergic... Read more
could not sleep; Tightness in chest; Caller states she could not take a deep breath; slight allergic reaction/The allergic reaction itself is the carrier agent for the mRNA polyglycol; redness on arm; Akathisia; arm had soreness; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old (53-year-old was reported) female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26May2021 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation at the age of 52-year-old. Medical history included hypothyroidism, does not know how long she has had, she takes t4 and t3 and is responsive with it; ongoing familial high cholesterol: she was 19 at like 300, asthma, overweight, allergic to polyglycol in scopolamine patches that was used for nausea. she does great with it, but the patch she gets a horrible red, weepy blister effect. she has had Akathisia with reglan or metoclopramide before, if she gets iv she just wants to rip it out and leave the room and get out. she does not use them anymore, that is why she has zofran and phenergan. The patient experienced tightness in chest on 26May2021, she could not take a deep breath on 26May2021, could not sleep on 27May2021, slight allergic reaction/the allergic reaction itself is the carrier agent for the mrna polyglycol in May2021, redness on arm where the needle went in in May2021, akathisia in May2021, arm had soreness in May2021, nausea in May2021. Outcome of all events was unknown. Therapeutic measures were taken as a result of tightness in chest, could not take a deep breath, nausea. The reporter states she had a side effect, she does not think an allergic reaction, but yeah it was a slight one. The allergic reaction itself is the carrier agent for the mRNA polyglycol which she believes is in scopolamine patches which she is allergic to. This started off as that. Within 20-30 minutes of getting the shot. That one she did not like, but she understands it when she looked at the carrier agent. Reporter states that scopolamine is used for nausea. The drug she does great with, but the patch she gets a horrible red, weepy blister effect. Caller provides no additional details, she states that she no longer has the patches because they were all taken away and she does not use them anymore, now she uses zofran. The redness is where the needle went in. she got the shot wednesday, and that was when her chest tightness, she treated it thursday but it was getting better enough she needs steroids, she could not take a deep breath, she is experiencing this still. Today when she got up, she could not sleep last night, her first thought was it was insomnia. She is taking albuterol to open her airways. She is taking sudafed and benadryl, like 100 mg of Benadryl. She also experienced akathisia, She wanted to sleep really bad but then she started moving around, because she has had this with reglan or metoclopramide before. she is not taking any other drugs that could cause this, that was the only thing.
52 2021-06-17 burning sensation When I got the shot, I immediately had a burning fire sensation through my left arm. It got more and... Read more
When I got the shot, I immediately had a burning fire sensation through my left arm. It got more and more intense as we left and went home. At the point where I had to go to the hospital was 3 days later. I broke out in a rash of pinprick blood spots all over my body. immune thrombocytopenia Where my blood platelets dropped. I looked like I was bleeding under my skin. My blood count dropped by at least 200-300. It was not so bad that I had to have a transfusion. It started me into a downward spiral of all my autoimmune system flaring. My dermatomyositis has really heightened. Up my neck, into my face was a deep red/scarlet. I felt like it triggered a flare in all my autoimmune issues. It took about 4 weeks from there for me to get better but months later, I have not regained the level of health I had prior to 3/15, when I received the vaccine. Last month I began taking a new immunosuppressant drug. I have pictures of the pinprick rash that appeared on my body.
52 2021-06-17 numbness PATIENT STATES SHE FELT "WEIRD" (DIFFERENT TASTE IN MOUTH; TOPOF HEAD AND LEFT ARM FELT NUMB; A LITT... Read more
PATIENT STATES SHE FELT "WEIRD" (DIFFERENT TASTE IN MOUTH; TOPOF HEAD AND LEFT ARM FELT NUMB; A LITTLE DIZZINESS BUT SHE SAID SHE'S DIZZY MOST OF THE TIME SINCE HER BOATING ACCIDENT). PATIENT REQUEST AND DRUNK HALF A BOTTLE OF WATER; AFTER SHE SHE SAID THE WEIRD TASTE IN MOUTH IS NO MORE. PT WAS ENCOURAGE TO EITHER WAIT A LITTLE FOR OBSERVATION OR GO IN THE AMBULANCE FOR FURTHER OBSERVATION. SHE DECLINED BOTH BUT RATHER DECIDED TO HAVE HER FRIEND(WHO CAME WITH HER) BRING HER TO THE HOSPITAL.
52 2021-06-17 numbness On the Saturday after receiving my 1st dose, I felt chest pain, right arm and right side of face num... Read more
On the Saturday after receiving my 1st dose, I felt chest pain, right arm and right side of face numbness. I was taken to ER.
52 2021-06-17 pain in extremity Headache, body aches, muscle aches, fever, fatigue, starting 24 hour after injection of the mRNA and... Read more
Headache, body aches, muscle aches, fever, fatigue, starting 24 hour after injection of the mRNA and lasting 2-3 days. Diarrhea on day 3. However, the headache, fatigue and muscle aches lasted 6-7 days. At that point, she began to develop pitting edema in both ankles and legs, this was worst on day 8-9 and is slightly improved, but still noticeable 2 weeks later. Also, left arm soreness for 3 days at the site.
52 2021-06-18 muscle spasms, flushing, pain in extremity Rash, Flushing Red skin upper abdomen, headache, fatigue, swelling in neck, pain in arm, cramps in c... Read more
Rash, Flushing Red skin upper abdomen, headache, fatigue, swelling in neck, pain in arm, cramps in calves, dizziness, vertigo. Symptoms began on June 15th, 2021 shortly after 2nd dose of Covid 19 Pfizer vaccine and continue until time of reporting June 19th, 2021. Rash and redness and leg cramps, swelling and arm pain lasted 24-72 hours. Others symptoms including headache and vertigo and fatigue continue to date of this reporting.
52 2021-06-20 migraine I got the vaccine on 3/30/2021 at about noon. At about 6 AM on 3/31/2021, I had a major, migraine-le... Read more
I got the vaccine on 3/30/2021 at about noon. At about 6 AM on 3/31/2021, I had a major, migraine-level headache. I had multiple loose stools. I had both symptoms daily since 3/31, and they ceased at the end of May.
52 2021-06-21 weakness O2 was 74/with new batteries, it was 88/has been hovering at 93 and 94 for the last hour 1/2; This e... Read more
O2 was 74/with new batteries, it was 88/has been hovering at 93 and 94 for the last hour 1/2; This evening quite suddenly was not feeling right similar to when I had Covid; Breathless; lightheaded; very weak; heart rate was 54 (normally 80); pulse was 113; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Jun2021 11:30 at 52 years of age (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Patient received the first dose of bnt162b2 on 08May2021 12:00 administered in arm left. Medical history included tachycardia, paroxysmal supraventricular tachycardia (PAT), severe joint pain from 06May2021, fatigue from 06May2021, fever from 06May2021, COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications included ibuprofen taken for severe joint pain, fatigue, pyrexia from 06May2021 20:40 and ongoing; paracetamol (TYNOL) taken for severe joint pain, fatigue, pyrexia from 06May2021 20:40 and ongoing; atomoxetine hydrochloride (STRATTERA); bupropion hydrochloride (WELLBUTRIN); levothyroxine; and atorvastatin. The patient previously took prednisone and experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination included Stratera, Wellbutrin, levothyroxine, and atorvastatin. On 06Jun2021 20:45, patient, quite suddenly, was not feeling right, similar to when she had COVID. Patient was breathless, lightheaded, and very weak. Patient got up and got her pulse oximeter. Her heart rate was 54, normally 80. O2 was 74 . Patient changed the batteries just to be sure. With new batteries it was 88, pulse was 113 . O2 steadily climbed to 97 but had been hovering at 93 and 94 for the last hour 1/2. Patient was recovering from the events. No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The case was reported as non-serious.
52 2021-06-21 facial paralysis Facial paralysis, lethargy, headache, joint pain, nausea
52 2021-06-21 feeling hot, tingling Patient received the 1st dose of the COVID vaccine (Pfizer Lot # ER8735 expiration date 07/05/2021) ... Read more
Patient received the 1st dose of the COVID vaccine (Pfizer Lot # ER8735 expiration date 07/05/2021) at 1738. At 1800, the client walked up to the EMT desk and asked EMT, "can you take my blood pressure." EMT asked the client if she was feeling alright. The client stated, "I feel some tingling in my finger tips and I'm a little hot and sweaty." PHN responded at 1801 and helped EMT escort her to the zero gravity chair. The client denied any shortness of breath, difficulty breathing, or nausea. Vital signs were taken at 1802 (blood pressure 142/84, heart rate 62, oxygen 96%). PHN offered the client Benadryl at 1805, which she refused. Client has no medical history, no allergies and is not taking any medications. Vital signs taken at 1812 (132/84, heart rate 59, oxygen 97%). At 1812, client stated, "the tingling is gone. Maybe I was nervous. My friend passed out and vomited when she got her vaccine." Vital signs taken at 1822 (blood pressure 130/80, heart rate 52, oxygen 97%). EMT asked the client if this heart rate was normal for her, which the client replied, "yes." Vital signs taken at 1830 (blood pressure 122/72, heart rate 51, oxygen 97%). PHN advised client to follow up with primary care provider and an allergist, and provided education on when to seek emergency services. At 1832, client stated, "I feel fine now," and left the facility unassisted with a steady gait at 1832.
52 2021-06-21 flushing, difficulty speaking, migraine ONCE I GOT THE SECOND SHOT I HAD FACIAL CONGESTION, THEN MY EYES GOT BAGS UNDER THEM, I WAS HOARSE, ... Read more
ONCE I GOT THE SECOND SHOT I HAD FACIAL CONGESTION, THEN MY EYES GOT BAGS UNDER THEM, I WAS HOARSE, MY FACE SWELLED, I HAD NASAL/EAR/SINUS CONGESTION, SOB, AND SEVERE JOINT PAIN STARTED. I HAD TO TAKE A STEROID TO BREATHE. THEN I BEGAN WITH ITCHING AND SEVERE MIGRAINES ON THE DAY I DID NOT TAKE THE STEROID. I AM STILL SUFFERING A MONTH LATER FROM THE JOINT PAIN, FATIGUE, SOB, HOARSENESS, FACIAL SWELLING/CONGESTION, DARK CIRCLES UNDER MY EYES, SEVERE JOINT PAIN- I SAW THE ALLERGIST WHO GAVE ME MEDROL, XYZAL, AND XCHANCE- I HAD ADVERSE REACTION TO THE XYZAL-DIZZINESS AND FACE SWELLED AND I COULD NOT KEEP MY EYES OPEN OR STAND UP. SO NOW I JUST TAKE MEDROL 4MG DAILY SO I DONT HAVE ITCHING ALL OVER MY FACE/MIGRAINE/HOARSENESS./SEVERE JOINT PAIN. THE MEDROL JUST MAKES THE SYMPTOMS LESS. THE FATIGUE IS KILLING ME AND IM SO TIRED OF THE SYMPTOMS. MY STOMACH HURTS NOW TOO. I STARTED TAKING ZANTAC WITH CLARITIN FOR DOUBLE ANTIHISTAMINE EFFECT. MY MD DID LABS AND I GO BACK TO HIM.
52 2021-06-21 pain in extremity Tightness in chest, heaviness in chest, SOB when lying down, pains in chest sitting or standing or l... Read more
Tightness in chest, heaviness in chest, SOB when lying down, pains in chest sitting or standing or lying down, aches in center of chest, heart fluttering, pain in center right side of chest by heart. Headache, blurry vision, pressure in chest when bending over, swelling on left leg, lymph nodes swollen pain under arms. Left arm sore, rash off and on with redness.
52 2021-06-21 pain in extremity After getting the second shot, like at 1 pm I started having diarrhea and it lasted 4 days. I also h... Read more
After getting the second shot, like at 1 pm I started having diarrhea and it lasted 4 days. I also had extreme fatigue and my body and feet hurt a lot, it felt like I was having Covid-19 again. I still have the fatigue and pain and I wake up very tired and with pain in my feet. I cannot do a lot of things because I get very tired very soon. 2 days after having the vaccine I woke up and I noticed some red spots in my arms and there was a really big one close to my elbow. I still have those spots. The next day they became blisters, and I went to the hospital because they were very itchy. They did a Covid test, but it was negative. They said the spots were because of the vaccine but there was no problem and if the blisters popped, I should return to the hospital. However, that did not happen. They gave me an injection, but I do not remember the name of it. They did not do any medical tests they only looked at it. I still have the spots but now they are black instead of red.
52 2021-06-22 breast pain I started getting the arm lymph nodes being swollen right above my breasts and I was really scared. ... Read more
I started getting the arm lymph nodes being swollen right above my breasts and I was really scared. I am still tired from the vaccination. I saw the Dr. and they told me to place cold/hot compresses in my breasts. The swelling and pain is gone. The terrible nausea and diarrhea that I experienced had gone away after the day of the vaccination.
52 2021-06-22 unresponsive to stimuli Immediately after getting the first dose vaccine, I sat down and then I slumped over in seconds. I f... Read more
Immediately after getting the first dose vaccine, I sat down and then I slumped over in seconds. I fell asleep and I could not wake up. I could not even speak and could not respond when they asked my name. It felt like an out of body experience and a feeling of impending doom. My blood pressure was elevated and when I came around later. I spoke to my Allergist later and he advised that if I get the second one I should be observed. The extreme exhaustion persisted for a week.
52 2021-06-23 discomfort, tingling 12/21/2021, day of first dose I experienced chills, aches and general discomfort. I developed covid ... Read more
12/21/2021, day of first dose I experienced chills, aches and general discomfort. I developed covid shortly after first dose and I developed ulcers. Second dose was on 03/14/2021 and it wasn't until 04/07/2021 that my ulcers began worsening into mouth, throat, nose. Worsening of arthritis that I did not have before the vaccine. I started having a tingling sensation as well as exhaustion and depression, all of these symptoms are worsening. I am very dizzy and falling all the time.
52 2021-06-23 difficulty speaking Patient was administered the vaccine at 3:10pm. At 3:20pm, patient complained about shortness of bre... Read more
Patient was administered the vaccine at 3:10pm. At 3:20pm, patient complained about shortness of breath and bronchoconstriction. Patient had voice alteration, and reported this to the on-site Pharmacist. She also said that she feels her whole body is shaky and has a metallic taste in her mouth. So, at 3:20pm the first dose of Epi-pen was administered and 911 was called as a follow up. Patient's face was red, sweaty and her hands/fingers were shaking. Patient neck began turning red at the moment. It then seemed she was returning to normal but @ 3: 28pm , she complained that she is feeling that bronchoconstriction once again and the same metallic taste in her mouth. Another epi pen injection was administered at 3:28pm. EMS arrived at 3:32 pm and took patient to the local ER.
52 2021-06-23 tingling I had headache - it was more than a day later. I woke up at about 03:00 in morning but when I woke u... Read more
I had headache - it was more than a day later. I woke up at about 03:00 in morning but when I woke up again, I was fine and could go to work. Got a rash on 4/17/2021 - It was hideous. Middle of bottom lip - circle right underneath in the middle - it felt like hives coming out - tingly. And then on the right upper thigh - dark, red circle. I have pictures of them. It started to clear up. It happened again on 5/31/2021 - the two spots happened on the exact same place and then also two on my right boob and two on my left boob and two on my shins (one on each shin) - the shin ones were very light. I have pictures of these of my thigh and face. On May 31st, I had just taken Fluconazole - because I felt I was getting a yeast infection. But I don't remember taking that medication before I got that first rash on 4/17/2021. Dr (dermatologist) doesn't think it's a reaction to the Fluconazole. The doctor said we don't know if it's from something being dormant in my body and the vaccine unleashed it. I still have the rash from the 31st - but not on my face it's on my thigh and my boobs. My right boob - where they were most dark Face on is totally gone. Doctor gave me some kind of ointment to put on the round things - Clovaxol - topical cream - not sure about the name of it. And gave me another 5-7 days of Fluconazole and I did take it but it didn't give me a reaction this time with any new rashe/circles (rash).
52 2021-06-24 pain in extremity, weakness I gained weight at a rapid pace and a appetite that I could not control. I started getting dizzy an... Read more
I gained weight at a rapid pace and a appetite that I could not control. I started getting dizzy and was feeling like I had been drugged. I had extreme soreness in my arm. My energy level dropped down to the point of being extremely exhausted..
52 2021-06-24 pain in extremity toe pain/A week later her toes are improving but is still tender to touch; redness on both feet; Her... Read more
toe pain/A week later her toes are improving but is still tender to touch; redness on both feet; Her great toe on her right foot and the second toe on the left foot were red and inflamed; minor arm discomfort; This is a spontaneous report from a non-contactable consumer (patient herself) received via a sales representative. A 52-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: Not reported), dose 2 via an unspecified route of administration on 06Jan2021 as 2nd dose, single for COVID-19 immunisation. The patient previously received first dose of BNT162B2 for COVID-19 immunization. Medical history included diagnosed with COVID-19 on Oct2020 with mild symptoms and recovered with no sequelae. Patient reported she has no underlying conditions and occasionally takes vitamins, she is quite active and walks several miles a day, she had not injured her feet nor purchased new shoes. This is the first time this has ever occurred. She has no history of autoimmune diseases or Raynaud's. On 06Jan2021, after vaccination patient had some minor arm discomfort but no other issues. On 28Jan2021, Patient started to experience toe pain and redness on both feet, her great toe on her right foot and the second toe on the left foot were red and inflamed (she has pictures). A week later her toes are improving but is still tender to touch. The outcome of minor arm pain was unknown and for other events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
52 2021-06-24 pain in extremity Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Minor nausea; Feeling unwell; Arm... Read more
Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Minor nausea; Feeling unwell; Arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0182) via an unspecified route of administration in left arm on 13Jun2021 10:00 as 2nd dose, single for COVID-19 immunization. Patient medical history included high BP, migraines and known allergies to Compazine. The concomitant medications included estradiol, amitriptyline, propranolol HCL ER. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0178) via an unspecified route of administration in left arm on 23May2021 10:00 as 1st dose, single for COVID-19 immunization. Vaccine facility type was reported as Pharmacy or Drug Store. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Patient was 52-years-old and was not pregnant at the time of vaccination. On 14Jun2021 at 05:00, patient experienced injection site pain, tiredness, headache, muscle pain, joint pain, minor nausea, feeling unwell, arm pain. Patient did not receive any treatment for the adverse events. The outcome of the events was not resolved.
52 2021-06-28 pain in extremity, muscle spasms Severe fatigue started the following day, followed by severe axillary adenopathy on the left side (t... Read more
Severe fatigue started the following day, followed by severe axillary adenopathy on the left side (the side of the vaccine), then severe muscle spasm and radicular pain on the left arm, shoulder and neck
52 2021-06-29 inability to speak The patient developed a headache on 4/6/21 (vaccine #1 on 3/30) and one week after that was admitted... Read more
The patient developed a headache on 4/6/21 (vaccine #1 on 3/30) and one week after that was admitted to the hospital for fluent aphasia and diplopia from hemorrhagic stroke with sinus venous thromobsis noted on MRI the next day. Hospital course was complicated by partial complex seizures. She was admitted to hospital 4/13-4/19.
52 2021-06-29 weakness After the vaccine I start having increase muscle pains and I have no energy after I have been taking... Read more
After the vaccine I start having increase muscle pains and I have no energy after I have been taking my energy pills.
52 2021-06-29 numbness, tingling Tingling in hands; Tingling lips,; Lips felt swollen but it was not noticeable.; Forehead felt numb;... Read more
Tingling in hands; Tingling lips,; Lips felt swollen but it was not noticeable.; Forehead felt numb; Disorientation; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 05Mar2021 at 20:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included recurring Epstein Barr virus, burning mouth syndrome, anxiety, osteoarthritis and COVID-19. The patient was allergic to mercury, pollen and penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), cetirizine (ZYRTEC), folic Acid (MANUFACTURER UNKNOWN), and alpha lipoic acid (MANUFACTURER UNKNOWN); all for unknown indications from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 20:45, the patient experienced tingling in hands, tingling lips, lips felt swollen but it was not noticeable, forehead felt numb and disorientation. The patient was advised to take BENADRYL for treatment of the adverse events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of tingling in hands, tingling lips, lips felt swollen but it was not noticeable, forehead felt numb and disorientation were recovered on an unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.
52 2021-06-29 numbness Dizziness; Heart palpitations; Mild numbness; Tingling of tongue; Mild lower lip swelling; Frequent ... Read more
Dizziness; Heart palpitations; Mild numbness; Tingling of tongue; Mild lower lip swelling; Frequent urination; Fever of 99; Wrong site of drug administration; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269) via an unspecified route on left leg (wrong site of drug administration) on 21Mar2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto thyroidism and celiac disease. The patient was allergic to wheat, dairy, nitrous oxide and codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included B12 shot (MANUFACTURER UNKNOWN) for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Since the vaccination, the patient was not tested positive for COVID-19. On 21Mar2021 at 13:15, the patient experienced dizziness for about an hour, with heart palpitations, mild numbness, tingling of tongue, mild lower lip swelling, frequent urination (urinated 8 times in one hour) and fever of 99 (units unspecified). The events not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment received for the adverse events. The clinical outcome of the events dizziness, heart palpitations, mild numbness, tingling of tongue, mild lower lip swelling, frequent urination and fever of 99 were resolved on 21Mar2021. The clinical outcome of the event wrong site of drug administration was unknown. No follow-up attempts are possible. No further information is expected.
52 2021-06-29 pain in extremity Fatigue; Malaise; Minor arm pain; 101.7 Fever; Chills; This is a spontaneous report from a contactab... Read more
Fatigue; Malaise; Minor arm pain; 101.7 Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration on 19Mar2021 at 15:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included HTN (hypertension), hypothyroidism, PCN (penicillin) allergy, codeine allergy and Sulfa allergy. Concomitant medications included BYSTOLIC, Losartan/HCTZ (MANUFACTURER UNKNOWN), SYNTHROID and milk thistle (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E19267) via an unspecified route of administration on 16Feb2021 at 16:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 09:30, the patient experienced fatigue, malaise and minor arm pain, 18 hours post vaccination and experienced 101.7 fever and chills, 29 hours post vaccination. The patient did not receive treatment for fatigue, malaise, minor arm pain, fever and chills. The clinical outcome of the events fatigue, malaise, minor arm pain, fever and chills was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
52 2021-06-29 pain in extremity I went to see my doctor because of swelling and pain on both ankles, feet, and legs. The doctor said... Read more
I went to see my doctor because of swelling and pain on both ankles, feet, and legs. The doctor said I have edema. The pain and swelling is still ongoing on my ankles, feet and legs.
52 2021-06-29 pain in extremity Fever of 102; Headache; Body aches; extreme fatigue/ Slight fatigue on morning of day three; Extreme... Read more
Fever of 102; Headache; Body aches; extreme fatigue/ Slight fatigue on morning of day three; Extreme soreness in arm; Developed rash at injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6208 and Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 23Mar2021 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from Mar2020 to an unknown date. The patient was not pregnant at the time of vaccination and has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has no list of any other medications received within 2 weeks of vaccination. On 24Mar2021, the patient experienced fever of 102 (as reported), headache, body aches and extreme fatigue. It was reported that the symptoms were similar when the patient had COVID in March 2020. The symptoms lasted for two days following vaccine. However, it was reported that the patient further experienced slight fatigue on morning of day three. Also, the patient experienced extreme soreness in arm, and developed rash at injection right on 24Mar2021 (reported as on day two of vaccination). No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. The patient recovered from fever, headache, body aches and fatigue on 26Mar2021 and from extreme soreness in arm and rash at injection of an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
52 2021-06-29 pain in extremity Friday coughing; Sneezing runny nose; Sneezing runny nose; Pain at night in left arm; This is a spon... Read more
Friday coughing; Sneezing runny nose; Sneezing runny nose; Pain at night in left arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EP6955), via an unspecified route of administration in the left arm on 18Mar2021 at 09:15 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies to medications, food, or other products. The patient experienced pain at night in the left arm on 18Mar2021 at 18:00. The following day, Friday, on 19Mar2021, the patient experienced coughing, sneezing and runny nose. The patient did not receive any treatment for the reported events. The clinical outcome of the events painful left arm, coughing, sneezing and runny nose was recovering at the time of this report. No follow-up attempts are needed. No further information expected.
52 2021-06-29 pain in extremity Dizzy spell; Right arm soreness; This is a spontaneous report from a contactable consumer, the patie... Read more
Dizzy spell; Right arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727/WCHD), via an unspecified route of administration in the right arm on 23Mar2021 at 09:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included selective antibody deficiency(immunodeficiency), hypogammaglobulinemia, thrombocytopenia and arthritis. Concomitant medications included immune globulin (CUVITRU) and naproxen (ALEVE) taken for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Mar2021 at 10:00, the patient had dizzy spell within 10 mins and right arm soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the events dizzy spell and right arm soreness were resolved on an unknown date. No follow-up attempts are needed. No further information is expected.
52 2021-06-29 tingling This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non-pr... Read more
This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration on the left arm on 20Mar2021 at 13:00 (at the age of 52-years-old) as a single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medications included probiotic (MANUFACTURER UNKNOWN), ZYRTEC and multivitamin (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration on the left arm on 27Feb2021 at 13:30 (at the age of 52-years-old) as a single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced fever, chills, headache, body ache, stomach pain, fatigue, tingles in finger tips, sleepy (slept for hours), body sensitive to touch and puffy eyes on 21Mar2021 at 06:00. Treatment was not received for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events fever, chills, headache, body ache, stomach pain, fatigue, tingles in finger tips, sleepy (slept for hours), body sensitive to touch and puffy eyes were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
52 2021-06-30 inability to speak, difficulty speaking I started going hoarse on March 31, 2021 it got worse over a course of three weeks and I went to the... Read more
I started going hoarse on March 31, 2021 it got worse over a course of three weeks and I went to the urgent care: April 21, 2021, and the Dr. gave me three days of steroids' and Z-Pak to see if would help I was having trouble breathing and coughing and I completely lost my voice and I couldn't talk at all. On Monday April 26, 2021 Dr. called to see if I was doing better and I told him no and asked for more steroids and he didn't want to give me more so he referred me to a ENT specialist. On May 13, 2021 I got an appointments with the ENT. She used a scope up my nose and snake up my nose to get to my throat and vocal cords were paralyzed on the left, and my vocal cords on both side were atrophied. She determined that I had paralysis and she sent me to get a CT scan of my neck and chest. The scans were negative. I met with my PCP and gave me the results of the test. PCP Dr. stated that it may have been from the vaccine.
52 2021-06-30 difficulty speaking Liquid benadryl given at 11:59am following reports of itching of nose and eyes. Changes in voice or ... Read more
Liquid benadryl given at 11:59am following reports of itching of nose and eyes. Changes in voice or breathing which pt contributes to allergic reaction. 2nd benadryl given at 12:10pm, itchiness began to decrease, some itching at vaccination site. 12:30pm, pt reports increase in itchiness on head. Pt left at 12:46pm still reporting itching on head
52 2021-06-30 pain in extremity, weakness the bone marrow almost hurts; The caller can't move her left arm; Weak and tired; Weak and tired; he... Read more
the bone marrow almost hurts; The caller can't move her left arm; Weak and tired; Weak and tired; her left arm, it got swollen, very red and very painful; her left arm, it got swollen, very red and very painful; her left arm, it got swollen, very red and very painful; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0217) via an unspecified route of administration, administered in Arm Left on 17Jun2021 15:20 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL 12 HOUR,lot number OME2586A, expiry date Oct 2022) taken for an unspecified indication, start and stop date were not reported. The patient reported that her left arm got swollen, very red, and very painful after the first dose of the Pfizer BioNTech covid 19 vaccine yesterday,17Jun2021. The patient second dose is scheduled for 08Jul2021. She took Advil at 3:00 am and iced her arm and then the pain proceeded to run down her arm into her shoulder blade, the left side of her neck, and down into her left hand. The patient feels like she was kicked 4 times by a donkey or punched in the arm. It is like the patient has a Pop Eye Arm. There is a red spot where she was injected. The patient is also weak and tired. Other than the tetanus shot this is the worst thing that has ever happened to the her. The patient was told that if she is having this reaction then she is afraid of getting the second shot. The patient has given childbirth twice naturally and that was nothing compared to this. The patient still can't lift her arm, she feels like she has been shot with a gun, the bone marrow almost hurt. It is hard to say with the patient feeling weak and tired, she is pretty active at work and it was hot outside. The patient can't move her left arm. The patient had to call out of work today because it just wasn't happening ,can't sleep on her left side and has been tossing and turning. She stated when she woke up from the bed in the morning that couldn't lift her arm after receiving the vaccination and pain is an 8.5 on a scale of 1-10, she had taken Advil she stated that it didn't worked she bought the medication 5 weeks ago and product was described as Equate Ibuprofen, a bottle of 500 because of the reaction she was afraid to take the second dose of vaccination . Treatment was given for swelling, redness, pain in arm as Advil and ice. The outcome of the events asthenia, fatigue was not recovered and for all other events unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested.
52 2021-06-30 pain in extremity, nerve pain The day after receiving the second vaccine I started having severe nerve pain in my left leg. It go... Read more
The day after receiving the second vaccine I started having severe nerve pain in my left leg. It got so bad I had to use a walker to get to the bathroom. After the second day of excruciating pain I went to the hospital and was treated poorly and was told that it was probably sciatica and to use a Lidocane patch. The next morning I noticed some red sort of itchy patches on my leg were I put a patch and on my back. I thought it was an allergic reaction from the patch. I then visited my rheumatologist because the pain was getting worse. I told her about the rash and she checked to see if it was shingles and determined very quickly that it was not. Hours after I returned home I determined that it was shingles and called the doctor. An emergency doctor on call responded and sent a prescription to the pharmacy for Valtrex. I suffered terribly for almost 3 weeks with severe leg pain. I still have trouble sitting down and the nerve pain comes and goes. After a simple online search I discovered that my rheumatologist should have told me to take the shingles vaccine before taking the Covid vaccine. (My mother's rheumatologist told her to do that) I've also read that I may not have the anti-bodies due to my immuno-suppressive illness(Rheumatoid Arthritis). Taking the Pfizer Vaccine has made my life miserable.
52 2021-06-30 tingling, hot flush Face became hot and flushed; The right side of face had a slight rash; Face and forearms were tingly... Read more
Face became hot and flushed; The right side of face had a slight rash; Face and forearms were tingly; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the right arm on 22Mar2021 at 17:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 19:00, approximately 1.5 hours after receiving the vaccine, the patient's face became hot and flushed and the right side of the face had a slight rash, face and forearms were tingly, similar to the feeling of novocaine wearing off. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events hot flushes facial, rash face and tingling was recovered on an unknown date in Mar2021. Information on the lot/batch number has been requested.
52 2021-07-01 burning sensation Burning in toes and feet; eyelids were dry.; burning in my eyes and feet/felt both eyes started to b... Read more
Burning in toes and feet; eyelids were dry.; burning in my eyes and feet/felt both eyes started to burn.; burning in my eyes and feet; it is persisting and worsened.; This is Spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 09Jun2021 between 14:00 and 15:00 (at the age of 52-years-old), as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior Vaccinations within 4 weeks was None. Historical vaccination included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EW0185) via unspecified route of administration in the left arm, on 19May2021 in a daytime 15:00 or 16:00, as 1st dose, single for COVID-19 Immunization and experienced little weak. On 09Jun2021 (day of vaccination), after the needle was out of her arm, the patient experienced burning in her both eyes and feet, especially her left foot and it was still present. On 10Jun2021, the patient experienced burning in toes and feet, eyelids were dry. Caller stated that she did not even feel the needle go in her arm. It was reported that the patient took Pfizer BioNTech Covid-19 Vaccine because lots of people died without it and she figured that she needed to get it. Caller stated that she hadn't weighed herself in a while but she thought she would be about 230 pounds. Caller thought this would last only a little while. She got afraid since it kept going. She read up that toxins can cause burning like that. She wasn't sure what was in the syringe and had her questioning what was in the syringe. It started right after the shot. It burned the rest of the day and into the night. Caller said she woke up last night and it was still burning. This morning it felt like her eyelids were dry. She didn't feel burning as much. They were just dry. It improved but her eyelids were dry. She said the burning in her eyes was a 10 yesterday but a 1 now. Caller stated that her toes were burning especially the left. It moved down from the top to the bottom of the foot. It started this morning. Caller looked on the website for side effects and this was not on the list for side effects. The burning started with the toes and spread to the middle of feet, especially left foot. She was drinking water to try and get the toxins that were in there out. She did not know what would cause this as it was not on the list of side effects. It spread form the toes to the foot. Caller said the right toes were burning but not as bad as the left. Caller stated that she did not do anything but drink water to try and get the toxins out. She went online and say there were toxins in the vaccine and she was wondering about the toxins and what was in the syringe, or if it was outdated. The outcome of the events burning in my eyes and feet/felt both eyes started to burn, burning in toes and feet were not recovered. The outcome of the events eyelid skin dryness and condition aggravated was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up (11Jun2021): This is a follow up spontaneous report from a PPD Pfizer. This PPD Pfizer reported in response via mail follow-up activity which included that: After listening to the call recording associated with the caller confirmed the spelling of her first name. Additional information has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021683896 same patient/drug, different dose/event
52 2021-07-01 numbness, tingling Left arm and leg falling asleep. Numbness in left leg; Tingling sensation in left leg into foot; Thi... Read more
Left arm and leg falling asleep. Numbness in left leg; Tingling sensation in left leg into foot; This is a spontaneous report from a contactable nurse, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7534), via an unspecified route of administration on left arm on 23Mar2021 at 09:45 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient was allergic to lisinopril, ULTRAM, and ROBAXIN. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), LEXAPRO, NORVASC for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Mar2021 at 12:00, about 14 to 15 hours after injection, patient noticed that left arm and leg falling asleep. Patient still had numbness and tingling sensation in left leg into foot. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events numbness and tingling sensation in left leg was not recovered. No follow-up attempts are needed. No further information is expected.
52 2021-07-01 pain in extremity The patient presented at the pharmacy on 7/2/2021 and reported having continuous arm pain and discom... Read more
The patient presented at the pharmacy on 7/2/2021 and reported having continuous arm pain and discomfort since the shot was given on 6/25/2021. The arm pain seems to be mostly focused in the joint and she has difficulty raising her arm overhead. The pain has subsided some but she was concerned because its been over a week. The discomfort is affecting her job and has not completely resolved.
52 2021-07-01 pain in extremity Pain in the left arm from the fingers to the head. Chest pain and shortness of breath.
52 2021-07-02 unresponsive to stimuli, seizure Patient fainted and felt dizzy and weak. Has a history of allergies and made it known that she carri... Read more
Patient fainted and felt dizzy and weak. Has a history of allergies and made it known that she carries an EpiPen. Became unresponsive and had small convulsions, lasting less than a minute. Used an EpiPen (one dose) and she became responsive again. EMS was called and took over once they got to the store. They took her to the emergency room for evaluation. Patient maintained breathing and pulse through the entire event, no CPR was needed.
52 2021-07-04 numbness headache joint pain blurred vision tiredness diarrhea swelling feet numbness shortness of breath
52 2021-07-06 difficulty speaking, migraine I cannot breathe; Nasal congestion; Swelling face; Hoarseness; Sob; Ear congestion; Swelling/fluid r... Read more
I cannot breathe; Nasal congestion; Swelling face; Hoarseness; Sob; Ear congestion; Swelling/fluid retention; Swelling/fluid retention; Bags under my eyes; A severe migraine; Massive headaches; Severe joint pain; This is a spontaneous report from a contactable other health care professional nurse. This nurse (patient) reported that a 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ew 0179), dose 2 via an unspecified route of administration, administered in left arm on 21May2021 17:15 (Age at vaccination 52 years) as dose 2, single for covid-19 immunization. Medical history included autoimmune disorder (told i need genetic testing to figure out which one) , Allergy to antibiotics (all oral antibiotics), Latex allergy, Shellfish allergy (fish/shellfish), Allergy (preservatives in meds, demerol/codeine/antifungals, met allergy meds), Kidney stone and Avascular necrosis of bone (AVN bilateral hips). Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient previously took codeine, demerol and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unknown route of administration on Apr2021 at 05:15 PM in Arm Left (Batch/Lot number : ew0171) as dose 1, single for covid-19 immunization. On 22May2021 12:00 AM, the patient experienced i cannot breathe; nasal congestion; swelling face; hoarseness; sob; severe joint pain; ear congestion; swelling/fluid retention; massive headaches; bags under my eyes and a severe migraine. Patient was received steroids, steroid nasal spray and antihistamine as treatment for events. It was reported that if patient do not take prednisone patient get a severe migraine, extremely hoarse, swollen face and patient cannot breathe and joint pain severe. Patient had an auto immune problem and multiple drug allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was received medications within 2 weeks of vaccination (Claritin). The clinical outcome of all events were not recovered. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event dyspnea and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
52 2021-07-06 tingling, numbness Onset of tingling/numbness the day following 2nd covid vaccine. Diagnosis sensory ganglionopathy fol... Read more
Onset of tingling/numbness the day following 2nd covid vaccine. Diagnosis sensory ganglionopathy following a "GBS like" episode.
52 2021-07-06 tingling At 1249, patient reported tingling and itchiness in lips and left arm. Patient denied difficulty swa... Read more
At 1249, patient reported tingling and itchiness in lips and left arm. Patient denied difficulty swallowing, breathing, itchiness, rashes, and hives. Patient given water. Patient able to swallow water. Patient reported allergies to olive trees. Patient reported history of hypertension and took her medication in the morning. Lead nurse offered 911. Patient refused 911. At 1254, EMT assessed patient vitals: blood pressure 160/90 mmHg and pulse rate 67 beats/minute. At 1255, lead nurse administered intramuscular diphenhydramine 50 mg/1 ml in patient's right arm. Patient advised to wait for further observation. At 1305, EMT reassessed patient vital signs: blood pressure 158/82 mmHg and pulse rate 66 beats/minute. At 1318, EMT reassessed patient vital signs: blood pressure 162/86 mmHg and pulse rate 69 beats/minute. At 1328, EMT reassessed patient vitals: blood pressure 168/86 mmHg and pulse rate 68 beats/minute. Lead nurse assessed patient. Patient denied tingling and itchiness in lips and left arm. Patient denied drowsiness. Patient offered transportation. Patient refused transportation. Lead nurse educated patient on signs/symptoms of when to seek care, to sign up on v-safe, and to follow up with primary care provider. At 1333, patient left facility with unlabored respirations and steady gait.
52 2021-07-07 mild one side paralysis, nerve pain 1 month post vax: Swollen Right Breast Acute Nerve Pain in upper ab/chest Breathing difficulty - sp... Read more
1 month post vax: Swollen Right Breast Acute Nerve Pain in upper ab/chest Breathing difficulty - splinting Fatigue Arm weakness - can?t make fist Right ear pain 2 month post vax (add): Lower spinal cord pain Muscle weakness right leg, right ankle, right forearm Right diaphragm difficulty breathing Neuralgia upper right chest Fatigue Unstable balance
52 2021-07-08 facial pain left sided facial swelling, redness, severe pain started 06/30/2021,. Went to ER 06/03/2021 treated... Read more
left sided facial swelling, redness, severe pain started 06/30/2021,. Went to ER 06/03/2021 treated with Kflex QID without improvements
52 2021-07-08 flushing, hot flush, feeling hot Patient with complaints of feeling flush and hot. Also with complaints of an odd taste in mouth. ... Read more
Patient with complaints of feeling flush and hot. Also with complaints of an odd taste in mouth. Offered water and observed. BP 120/70, HR 82 Pulse-Ox 97. Patient appears a bit flushed in upper arms and chest. States she sometimes has menopausal hot flashes. Advised the patient to stay to be observed an extra 15 minutes. Also advised to seek medical attention if symptoms become worse. In check before leaving patient states she feel good. Less flushed..
52 2021-07-08 numbness, tingling Tingling/paraesthesia/paraesthesia in leg,foot/paraesthesia in arm, hand; numbness; fever; chills; s... Read more
Tingling/paraesthesia/paraesthesia in leg,foot/paraesthesia in arm, hand; numbness; fever; chills; severe headache; swelling painful lymphnodes on neck; swelling painful lymphnodes on neck; stumbling/Trouble walking; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration, administered in Left arm on 02Mar2021 at 13:15 (at the age of 52 years) as Dose number Unknown, Single for COVID-19 immunization.The patient's medical history included environmental pollen and some fruit, nuts and soy along with Severe allergies and asthma, Cranial nerve palsy after viral cold and Trigeminus neuralgia. Patient's Concomitant medications were not reported. Patient did not receive any other vaccines within 2 or 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination.1 hour after injection, on 02Mar2021 at 14:30, the patient experienced Tingling, numbness and paraesthesia in leg, foot, arm and hand on left side of body. Followed by fever, chills, severe headache and swelling painful lymph nodes on neck.1 week after vaccination, no improvement on numbness in leg and foot but spreading over to right side as well. Trouble walking and stumbling at times.AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.No treatment received.The outcome of the events was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
52 2021-07-08 muscle spasms, tingling Tingling; Spasm -legs; body fever; This is a spontaneous report from a contactable Nurse. This 52-ye... Read more
Tingling; Spasm -legs; body fever; This is a spontaneous report from a contactable Nurse. This 52-year-old (age at the time of vaccination) female Nurse reported in response to HCP follow-up letter sent in cross reference case that included who received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 2 (Lot number and expiry date was not reported) via an unspecified route of administration on 14Jan2021, as a dose 2, single for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE dose 1 (Lot number EJ1685 expiry date was not reported) via intramuscular route of administration on 20Dec2020 10:00 in left arm as a single dose for covid-19 immunisation. The patient provided information to you regarding the reported adverse event(s) with the use of the product and considered the Pfizer product had a causal effect to the adverse event. Patient's height was reported as 5foot 3inch and weight as 134 lb. Patient experienced tingling, spasm-legs, body fever o 17Jan2021. After 3 days of 2nd dose - still experiencing until now- 2nd vaccination date 14Jan2021. Vaccination Facility Type was reported as workplace clinic. Vaccine was not administered at Facility. Patient was not deceased. Treatment as muscle relaxant was required for the events. The events required visit to physician's office (urgent care). The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
52 2021-07-08 pain in extremity Pfizer-BioNTech COVID 19 Vaccine EUA Arm is warm and sore since 7/7/2021. On 7/9/2021 noticed sligh... Read more
Pfizer-BioNTech COVID 19 Vaccine EUA Arm is warm and sore since 7/7/2021. On 7/9/2021 noticed slightly swollen pink circle area down my arm
52 2021-07-08 tingling, numbness After receiving my first shot , within 5 minutes my feet was numb and tingling . This lasted for 5... Read more
After receiving my first shot , within 5 minutes my feet was numb and tingling . This lasted for 5 hours I kept checking my sugar and blood pressure every hour . They were fine . I?m waiting to hear back from my doctor as this is not a listed side affect but I have read about many others having these issues .
52 2021-07-08 tingling Facial swelling and tingling both cheeks and nose. Nausea, Chills, no fever, tiredness, joint pain, ... Read more
Facial swelling and tingling both cheeks and nose. Nausea, Chills, no fever, tiredness, joint pain, muscle pain, headache. Stiff neck on left side, same side as injection site. Arm soreness at injection site
52 2021-07-08 tremor 05/18/2021 around 2AM I woke up in the middle of the night with severe chills and I took my temperat... Read more
05/18/2021 around 2AM I woke up in the middle of the night with severe chills and I took my temperature and it was 100.8 degrees. For me, I'm usually at 97.2 degrees. Everything in my body hurt. I stayed home from work the next day and the fever didn't break. I never got sweaty but it just didn't break. I treated it with either ibuprofen or Tylenol. It eventually went away and I was fine. A week later on 05/25/2021 the same thing happened where I woke up in middle of night shaking and a fever of 101.3 degrees. Every part of my body hurt, behind my eyeballs hurt. I called my doctor and because I had a fever and she said I couldn't come into the office. My heart was fluttering as well and she said just go to the ER and get checked out and have them do a COVID test even though I'm fully vaccinated. I went to hospital and they did a rapid PCR COVID test which came back negative but my blood work, liver was off, proteins were off. The doctor did not come anywhere near me and told me I had UTI, gave me antibiotic, and sent me home. I've had UTI's before and I know what they feel like and this didn't feel like that. The next day 05/26/2021 I did a video visit with my doctor and I still didn't feel right. The fever part of it broke but she said that since I was still having the weird heart thing just go straight to ER so I said ok. The next morning my heart was fluttering so I went to the ER again but I went to a different hospital ER. They did blood work, EKG, Epstein-Barr, but no COVID test this time. My doctor had said to me that I really sound like I had COVID regardless of negative test. Again, the liver function was high, they did hepatitis ABC that all came back negative. Epstein-Barr came back high but not hugely high. They just said they didn't know what was wrong with me. They said it might be hepatitis or Epstein-Barr but I didn't have symptoms of mono. I did have tiny cough sometimes. They did a chest x-ray on me and didn't find anything mysterious. Over next few days they kept re-running blood and liver function test and it was still off for another 2 weeks. They sent me to cardiology because of shortness of breath and chest pain along with palpitations. He ordered more blood work and a stress echo. This past Tuesday 07/06/2021 he did angiogram thinking he would find blockages but he found nothing. He said my heart looked good but no explanation. I have never had heart palpitations before in my life. By 06/24/2021 my liver enzymes were back to normal but they're still not sure what is going on with my heart but from what he told me I don't have any blockages and my heart looks fine. My next appointment with cardiology is on 07/22 or 07/23. I was also having some vaginal bleeding and I was at the time 7 months into menopause. I went to Gynecology and they found polyps and I am going into have procedure to have polyps removed.
52 2021-07-09 migraine Six days after first Pfizer Covid shot, severe migraines off & on lasting 3 to 5 days. 6 to 7 days a... Read more
Six days after first Pfizer Covid shot, severe migraines off & on lasting 3 to 5 days. 6 to 7 days after second Pfizer Covid shot, severe nausea Off and on lasting 7 to 14 days
52 2021-07-10 facial paralysis, bell's palsy, slurring, tremor On 6/23/21, I thought I was having vertigo or a stroke, I was completely shaky, spinning, almost pas... Read more
On 6/23/21, I thought I was having vertigo or a stroke, I was completely shaky, spinning, almost pass out feeling. It lasted 10min. My equilibrium was off all day after, I had four days of severe headaches, my right ear bothered me and had a slight loss of taste. By Sunday 6/27/21 I had to go to urgent care as the right side of my face was not moving and my speech was slurring. They diagnosed me with Bells Palsy and asked if I had had the vaccine. I am still dealing with the Bells Palsy.
52 2021-07-10 muscle spasms Right after the injection within a couple of days I got my period which I have not had in over six m... Read more
Right after the injection within a couple of days I got my period which I have not had in over six months and then I spotted three more times throughout the month of April and a couple of times and month of May. I?ve had severe cramping as well as pain in my ovaries.
52 2021-07-10 tingling, feeling cold, pain in extremity Cold, tingling in lower legs & feet - felt constantly for 3 days, now intermittent at night. dull in... Read more
Cold, tingling in lower legs & feet - felt constantly for 3 days, now intermittent at night. dull intermittent pain in left ankle, left foot, knee & calf, right foot & ankle tingling, lower arms tightness & dull pain in muscles, floating feeling, tinnitus - louder in left ear.
52 2021-07-11 numbness Pt. states received Phizer 1st dose 07/02/2021, Left hand/fingers going numb after 45mins. Rash ove... Read more
Pt. states received Phizer 1st dose 07/02/2021, Left hand/fingers going numb after 45mins. Rash over hands and feet, soreness in the left arm 2 days, vomited a little, fatigued, nauseous, fever when nauseous, loss of appetite (bland), taste buds effected. Alerted Physicians, told to just do a report. No physical physician appt. Prescribed Finnegan. ER recommended due to lack of physician's attention to the events.
52 2021-07-11 tremor Started having tightness in chest, shortness of breathing, fast heartbeat, body was shaking. Went to... Read more
Started having tightness in chest, shortness of breathing, fast heartbeat, body was shaking. Went to Emergency room. Took chest X-ray, blood work. All the heart and lungs related tests were normal. Doctor gave Prednisone 20mg, Benadryl shot, and Albuterol inhaler. Same symptoms repeated after couple of weeks. I could able to manage with Alegra, Nasacort, and Albuterol. Visited Cardiologist for heart evaluation in May. Cardiologist confirmed that heart is healthy.
52 2021-07-12 weakness Fever; chills; muscle and joint pain throughout body; ,muscle and joint pain throughout body,; weakn... Read more
Fever; chills; muscle and joint pain throughout body; ,muscle and joint pain throughout body,; weakness.; stiffness; brain fog; nausea.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8727), via an unspecified route of administration in the left arm on 26Mar2021 at 10:15 hours (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patients medical history included food allergy and COVID-19. Concomitant medications included pure encapsulations pure pack (supplement). The patient was allergic to nightshades (food). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 26March2021, at 21:00 hours patient experienced fever, chills, muscle and joint pain throughout body, weakness, stiffness, brain fog and nausea. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever, chills, muscle and joint pain throughout body, weakness, stiffness, brain fog, nausea was recovered on unknown date in March2021 at the time of this report. No follow-up attempts are needed. No further information is expected.
52 2021-07-12 burning sensation, pain in extremity I have excruciating pain in the souls of both my feet especially in the heel area. It feels like my ... Read more
I have excruciating pain in the souls of both my feet especially in the heel area. It feels like my feet are on fire and it hurts so badly to walk on them.
52 2021-07-12 numbness, tingling Diagnosis sensory ganglionopathy following a "GBS like" episode.; Onset of tingling/numbness the day... Read more
Diagnosis sensory ganglionopathy following a "GBS like" episode.; Onset of tingling/numbness the day following 2nd covid vaccine; Onset of tingling/numbness the day following 2nd covid vaccine; Diagnosis sensory ganglionopathy following a "GBS like" episode.; This is a spontaneous report received from a contactable consumer (patient). This 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 20Apr2021 at 09:45 (at 52-year-old), at single dose for COVID-19 immunization. Medical history included seasonal allergy gadolinium contrast MRI and allergic to metal (Nickel). Concomitant medications included vitamin b complex taken for an unspecified indication and ergocalciferol (Vit D) taken for an unspecified indication. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8734) via an unspecified route of administration on 30Mar2021 at 09:45 (at 52-year-old), at single dose for COVID-19 immunization. On 21Apr2021 at 01:00 pm the patient experienced diagnosis sensory ganglionopathy following a "gbs like" episode, onset of tingling/numbness the day following 2nd covid vaccine. The patient underwent lab tests and procedures which included gadolinium contrast MRI which showed Known allergies: Gadolinium contrast MRI. On 23 Apr2021 the patient had primary care appointment. On 26Apr2021 she had neurology appointment. On 25Jun2021 she had neurological testing. The patient continued care and was referred to rheumatology. The patient had not recovered.
52 2021-07-12 muscle spasms, flushing When I received both the 1st and 2nd doses of the vaccine I was in good health. I was walking and jo... Read more
When I received both the 1st and 2nd doses of the vaccine I was in good health. I was walking and jogging 6 miles a day. The minute I received the vaccines I got a metallic taste in my mouth, flush and then felt sick for an hour. That went away both times. However I have had muscle cramping and severe fatigue and aching since the 1st dose and have not been able to walk more than a few blocks or exercise since. It has now been 3.5 months of waiting for the flu-like symptoms to go away. My muscles go into cramps doing small things like stairs or an incline on the street or even just house cleaning getting up and down and I get out of breath. I have been to the doctor and cannot find the cause.
52 2021-07-12 night sweats Shortness of breath, and could not catch breath and felt like there was fluid in lungs, night sweats... Read more
Shortness of breath, and could not catch breath and felt like there was fluid in lungs, night sweats, no fever IV Drip, Breathing treatments X2 6/23 Prednisone, Course of Antibiotics(5-day), and later was prescribed Zithromax and Albuterol for nebulizer
52 2021-07-12 pain in extremity Soreness in arm administered; Soreness in neck; Soreness in back shoulder blade; Underarm lymph was ... Read more
Soreness in arm administered; Soreness in neck; Soreness in back shoulder blade; Underarm lymph was swollen and hurting; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6204), via an unspecified route of administration in the left arm on 08Mar2021 at 13:30 (at the age of 52-years-old) as a single dose for Covid-19 immunisation. Relevant medical history included allergies to foods (unspecified) and medications (unspecified). Patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced soreness in arm administered from neck to back shoulder blade. The patient reported that this soreness lasted for two days. On an unknown date in Mar2021, a week after, the patient experienced swollen and hurting underarm lymph. Therapeutic measures were taken as a result of swollen and hurting underarm lymph which included treatment with Tylenol. The patient reported that the pain had started to lessen but was still present. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event soreness in arm administered from neck to back shoulder blade was resolved on 18Mar2021. The clinical outcome of the events swollen and hurting underarm lymph was resolving at the time of report. No follow-up attempts are needed. No further information is expected.
52 2021-07-13 pain in extremity I decided to sit for 30 mins after the 2nd vaccine. At about 15 minutes after the vaccine, I was lig... Read more
I decided to sit for 30 mins after the 2nd vaccine. At about 15 minutes after the vaccine, I was lightheaded, and my heart started to beat bad. I also had extreme chest pain. They took my vitals and I started to sweat profusely. Based on my vitals and my symptoms they thought I was having a heart attack. They took me over to the ER, and I started to experience kidney pain. The pain from that was so bad I thought I was going to vomit. They took me back into one of the rooms and they started all the test to see if I was having a heart attack. I started to have trouble breathing. My pulse was okay. All the tests came back inconclusive. My EKG came back abnormal. They discharged me to go home. I went back to the ER less than a week later because I was experiencing COVID like symptoms. I was tachycardic and had hard time breathing. I had swelling in my arm where the injection was given. I was unable to dress like normal and I could not even walk my dog without being out of breath. I went to the Urgent Care and they diagnosed me with a Pleurisies' and System Inflammatory. They prescribed me a steroid and I was told to take it for 10 days. They also gave me an inhaler as well. They did not do anything. I went back to the doctor after the steroid, and I was still having difficulty breathing. I had joint pain, headaches, I was still unable to take a deep breath. I was sitting at my kitchen table and passed out. I woke up on the floor. I drove myself to the ER and they were going to admit me, and they treated me for a migraine. They decided to a migraine cocktail. I had extreme pain in my lower legs. They were afraid of me having a DVT. They did an ultrasound and did not find a DVT. They decided to send me home. Between the last visit to now I have had between 5-7 more visits to the ER and urgent care due to not being able to breath and the joint pain. I have Dilated Aortic Root Valve and I am also Tachycardic neither of which I had before. Now I am better, but I do at times have difficulty breathing.
52 2021-07-13 tenderness, speech disorder Approx 18 hours later I was urinating when I had a sudden onset of pain start from the nape of my ne... Read more
Approx 18 hours later I was urinating when I had a sudden onset of pain start from the nape of my neck and go up into my head - it was like brain freeze times 10, the initial feeling lasted about 15 seconds but after it went away I was left with residual pain in the head and my head felt sore when touching my forehead and I was all of the sudden tired. I was working from home so I notified my manager about this and asked to go lay down. I went any lay down and fell asleep for a few hours, when I woke, I still have the pain and was nauseous. The pain, nausea and tiredness lasted about 3 days. Since then I have been having intermittent issues with speaking a full sentence without stuttering, getting a full thought out, typing properly (constantly misspelling words and having to go back and correct them), completing every day tasks correctly (for example, I was making my coffee and went to get the milk but past the refrigerator and walked to the other end of the kitchen, opened my broom closet and reached up for the milk, immediately realizing what I did I said to my self I was injected with "stupid juice"). I have been saying I was injected with stupid juice since about a week after my first injection as this is when I began to realize all these "stupid" things were happening. I forgot it was fathers day and when speaking with my son at the end of our conversation he asked if I was ok and I said yes why and hew said becasue you always wish me happy fathers day, then I wished my brother a happy birthday on facebook and my other brother commented that I freaked him out thinking he forgot it but then realized I was a day early- many were shocked because I am known for remembering dayes and events.
52 2021-07-14 difficulty speaking, cold extremities, electric shock sensation, numbness, flushing Within 5 minutes of receiving the vaccine (Friday 7/9/21), started feeling dizziness, whoozy, flushe... Read more
Within 5 minutes of receiving the vaccine (Friday 7/9/21), started feeling dizziness, whoozy, flushed, scratchiness in throat, pulse 49; stable after 30 min; pharmacist brought out the EpiPen, just in case. Within 2-3 hrs., tingling, numbness, fullness of lips, scratchy throat and raspy voice, tipsy sensation, general overall "weird" feeling; during the same timeframe, felt a numb, tingling, cold sensation of my left ring finger. By late evening, I started feeling a "zapping" sensation that occurred randomly throughout my body, like small, low voltage zaps or static charges. By late morning the following day (Saturday), started to feel a "bubble" sensation in my chest and throat, which continued intermittently. By evening time, lips finally normal, but throat was very dry/raspy; zapping sensations continued. By mid-day the next day (Sunday), central chest pressure persisted and became more noticeable; went to the ER, had a full workup for chest pain, which was all normal. By Monday, all symptoms had resolved.
52 2021-07-14 numbness Numbness extremities fingers, arms and toes on both sides.
52 2021-07-15 migraine Migraine
52 2021-07-15 tingling, pain in extremity Fever lasting two days, pain in the right arm. Significant swelling in hands and feet making it im... Read more
Fever lasting two days, pain in the right arm. Significant swelling in hands and feet making it impossible to grip things with hands. 10 days later, extreme paresthesias in the upper and lower extremities, face, and tongue lasted for two months. The numbness in the tongue and hands continue. Severe shortness of breath is continuing. Respiratory disorder continues, unable to clear my lungs after several Dr. visits and ER visits. Xray of the lungs, however, seems clear.
52 2021-07-15 tingling So it started the night of my vaccine, I had headache and body aches. It was really bad headaches fo... Read more
So it started the night of my vaccine, I had headache and body aches. It was really bad headaches for the whole week, the body aches went away after about 3 days though. Then in the week I started feeling the tingling in the right side of my body, just tingling like all over that part of my body and I still have that tingling now. It had gotten a little bit better but it is still prominent, I also get a lot of itching which will not go away. I had a telehealth with my DR on 5/20/2021 and he asked me to go in person on 5/28/2021 and he asked me to go for an MRI and they said they did not see anything. I have another follow up with him in a few days. At this point, half of my right leg and half of my right arm are tingling. I take a bunch of migraine medications and literally nothing is helping with the headaches either.
52 2021-07-16 feeling hot DVT blood clot in distal femoral vein. Felt warmth and saw swelling on right leg thigh. Observed for... Read more
DVT blood clot in distal femoral vein. Felt warmth and saw swelling on right leg thigh. Observed for 24 hours before seeking ultrasound which confirmed. Started blood thinners. 2 shots of Lovenox followed by Xeralto the next day. On Xeralto for 6 months.
52 2021-07-16 flushing, tremor Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: ears clogged
52 2021-07-16 tingling, numbness The 2nd dose of the vaccine was very painful when first injected them a metallic taste in my mouth ... Read more
The 2nd dose of the vaccine was very painful when first injected them a metallic taste in my mouth followed by numbness and tingling on the left side of my face and dizziness. Fave numbness subsided and metallic taste subsided after a few hours . However Continuous throbbing and pain after continue after 17 days post injection . Pain is on left deltoid and numbness and tingling , down the left arm day as he night . Shoulder pain and a feeling of numbness on hand . Weakness, numbness and tingling persists on the left arm to the point of having to stop doing activities . Pain in injection site keeps me awake at night .
52 2021-07-17 weakness, involuntary muscle movements, numbness, tingling, electric shock sensation, muscle spasms Irregular heart rate, abnormal ekg, irregular blood pressure, irregular heartbeats, chest pain, ches... Read more
Irregular heart rate, abnormal ekg, irregular blood pressure, irregular heartbeats, chest pain, chest heaviness, crippling insomnia, numbness and tingling in ams, legs, hands and feet. Feeling of electric current through whole body. Feeling of fizzing bubbles under skin. Feels like hot fizzy water being poured over legs and hands. Jerky muscle spasms mainly in arms. Fever, severe whole body muscle pain, joint pain, feel so revved up like adrenalin is pouring through my body not in a good way. Swollen thyroid and thyroid numbers dropped way under oprimal.
52 2021-07-17 weakness Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Read more
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Weakness-Mild, Additional Details: Following patients first dose of Pfizer, she reported a it swelled up like a "large marble". She reported redness that went all the way down her arm and it took about 1 week for pain and redness to improve. There still is a hard node under her skin at the site where vaccine was administered. Patient came in for second dose and reported these symptoms from 6/22. Instructed patient to follow up with PCP and to monitor.
52 2021-07-17 bell's palsy 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 day... Read more
6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; This is a spontaneous report from a contactable consumer. This 52-years old female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 0757620) via an unspecified route of administration on an unknown date in Jun2021 (at 52-year-old) in right arm as dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination were reported as none. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for covid-19 since the vaccination. The patient previously took psyllium husk powder, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 0757620) via an unspecified route of administration on an unknown date in 23May2021 at 03:30 PM (at 52-year-old) in right arm as dose 1, single for COVID-19 immunization. On 23Jun2021 the patient felt like her equilibrium was off, she had pain in her ear, had severe headaches for 4 days and developed Bells Palsy on 26Jun2021. Therapeutic measures were taken with prednisone and valacyclovir. The patient had required emergency room visit. On 27Jun2021 the headaches recovered. The events of headache, pain in her ear and equilibrium was off had not recovered. The device date was 29Jun2021. Follow-Up (01Jul2021): Follow-up attempts were completed. No further information was expected.
52 2021-07-17 burning sensation, tingling Mild prickly sensations on the back of hands.; burns to wash my hands; This is a spontaneous report... Read more
Mild prickly sensations on the back of hands.; burns to wash my hands; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) in the arm right on 11Mar2021 at 10:30(at the age of 52-year-old) and the patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533) in the arm right on 31Mar2021 at 13:30(at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have allergies to medications, food, or other products. On 18Mar2021, the patient experienced mild prickly sensations on the back of her hands, soon after the booster dose the sensations were more intense and burns to wash hands. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events mild prickly sensations on the back of hands and burns to wash hands were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
52 2021-07-17 burning sensation sharp pain/pressure in chest; sharp pain/pressure in chest; elevated heart rate; sharp pains in head... Read more
sharp pain/pressure in chest; sharp pain/pressure in chest; elevated heart rate; sharp pains in head; burning sensation on top and back of head, arm and back; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6208) via an unspecified route of administration in the right arm on 15Mar2021 at 14:30 (at the age of 52-years-old) as a single dose for Covid-19 immunisation. The patients medical history included hypothyroidism and supraventricular tachycardia. The patient took unspecified medication within two weeks, prior to COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9269) via an unspecified route of administration in the left arm on 21Feb2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation and Penicillin on an unknown date for unspecified indication and experienced a Penicillin allergy and codeine on an unknown date for unspecified indication and experienced a drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine .Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the Patient had not tested for COVID-19. On 15Mar2021 at 21:00, patient experienced sharp pain/pressure in chest, elevated heart rate, sharp pains in head accompanied by burning sensation on top and back of head and in arms and back. The patient did not receive any treatment for the reported events. The events resulted in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care visit. The clinical outcome of the chest pain, chest pressure, head pain and burning sensation were not resolved and of the increased heart rate was recovered on unknown date. No follow-up attempts are needed. No further information is expected.
52 2021-07-17 migraine migraines; nausea; vomiting; pressure around midchest area; feeling of fullness; dehydration; low gr... Read more
migraines; nausea; vomiting; pressure around midchest area; feeling of fullness; dehydration; low grade fever; tiredness; lost 38 lbs; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0162), via an unspecified route of administration, in arm left, on 12Apr2021 (at the age of 52-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included sleep apnoea, type 2 diabetes, high blood pressure, high cholesterol, depression from an unknown date and unknown if ongoing. The patient had no known allergies. The patient previously received first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6207), via an unspecified route of administration, in right arm, on 22Mar2021 as single dose for COVID-19 immunisation and reported tiredness. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient has been tested with covid-19. It was reported that on 17Apr2021, 5 days after 2nd dose, the patient had experienced severe migraines (which he never had before this), uncontrollable nausea and vomiting causing 2 ER visits due to dehydration; pressure around midchest area and feeling of fullness after eating a few bites of food; sought gastroenterologist help who suspects gastroparesis, low grade fever, tiredness on 15Apr2021 (3 days after injection) and lost 38 lbs on 13Apr2021. The patient reported that she was scheduled for additional gastrointestinal testing and lost 38 lbs between 13Apr - 1Jul not due to diet or exercise. The events lead to the emergency room and physician office visit. The patient underwent lab tests and procedures which included low grade fever: low on 15Apr2021 and COVID-19 NAT Nasal Swab test: negative on 01Jun2021. Therapeutic measures were taken as a result of dehydration, low grade fever, tiredness, migraines, nausea, vomiting, pressure around midchest area that included medications, IV fluids. The outcome of the events dehydration, low grade fever, tiredness, migraines, pressure around midchest area lost 38 lbs was reported as not resolved and the patient recovered from nausea and vomiting on 01Jul2021.
52 2021-07-17 muscle spasms, numbness Piriformis syndrome; muscle spasms; both legs going numb to toes; Could barely move for weeks; This ... Read more
Piriformis syndrome; muscle spasms; both legs going numb to toes; Could barely move for weeks; This is a spontaneous report from a contactable consumer(patient). A 52-years-old-female patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number Ew0169), via an unspecified route of administration at Arm Left on 05Apr2021 at the 52 years old at single dose for COVID-19 immunization. The medical history was none. The concomitant medications were not reported. There were no known allergies. The patient was not pregnant. The Historical Vaccine was first dose BNT162B2(lot number=Er8733) in 2021(08:30 AM) at 52 years old at Left arm for Covid-19 immunization. On 10Apr2021 08:30 the patient experienced Piriformis syndrome, muscle spasms and both legs going numb to toes, Could barely move for weeks. All of the events caused Emergency Room Visit and Physician Office Visit. The patient received Cortisone anti inflammatory and physical therapy as treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
52 2021-07-17 pain in extremity Soreness in arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-ol... Read more
Soreness in arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: C19 ER873V) via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and type 2 diabetic. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient had received any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 09:45, the patient experienced soreness in arm. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event soreness in arm. The clinical outcome of the event soreness in arm was resolving at the time of the report. No follow-up attempts are needed. No further information is expected.
52 2021-07-17 pain in extremity he said I have trigger figure; The night of the first injection I woke up with pain in my right thum... Read more
he said I have trigger figure; The night of the first injection I woke up with pain in my right thumb area; My thumb was what I though sticking in a locked position; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 05Apr2021 (at the age of 52-year-old) (Batch/Lot Number: Ew0176) as dose 2, single for covid-19 immunisation. Medical history included known allergies to hormones patch. The patient was not pregnant. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 for covid-19 immunisation on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021, the night of the first injection, the patient woke up with pain in her right thumb area. Her thumb was what she thought sticking in a locked position. She wasn't sure what was going on so she massaged it and went back to sleep and it continued to stick. After a month, she saw her primary doctor who referred her to a hand specialist and he said the patient had a trigger "figure". The events resulted in doctor or other healthcare professional office/clinic visit. Therapy for the events included a cortisone shot in right thumb. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19. The patient underwent a nasal swab (rapid covid) on 15May2021 with negative results. Outcome of events was not recovered.
52 2021-07-17 pain in extremity Bad nausea; Abdominal upset; Lightheaded; Tired; Joint hurt; Strong metallic taste; Arm hurt; This i... Read more
Bad nausea; Abdominal upset; Lightheaded; Tired; Joint hurt; Strong metallic taste; Arm hurt; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 52-years-old) at 10:30, as a single dose for COVID-19 immunisation. Medical history included RA (rheumatoid arthritis), Reynauds and bone cancer. The patient has known allergies to inapsine and guaifenesin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Started with in minutes on 23Mar2021, patient experienced strong metallic taste in mouth. It got worse as the day went on and was still current. Her arm hurt during the night and current. On 24Mar2021 at 10:30 (It was 24 hours in and she had bad nausea and abdominal upset, was somewhat lightheaded, tired and had joint hurt). she experienced bad nausea, abdominal upset, lightheaded, tired and joint hurt. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment for nausea. The clinical outcome of metallic taste in mouth, arm hurt was not recovered and outcome of the events bad nausea, abdominal upset, lightheaded, tired, joint hurt was resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained
52 2021-07-17 tingling, pain in extremity, numbness Face numbness began 25 minutes following injection, and extreme pain in left jaw, neck, shoulder and... Read more
Face numbness began 25 minutes following injection, and extreme pain in left jaw, neck, shoulder and arm, very loud tinnitus also started same day; approximately one week later, began experiencing numbing and tingling in face around nose, cheeks, lips, and tongue, and both forearms and hands, and both legs below the knees and feet; numbing/tingling feeling and tinnitus ongoing for over six weeks and continues as of this report.
52 2021-07-18 muscle spasms, weakness, tenderness, numbness, tingling SIDE EFFECTS FROM Pfizer- April 5, 2021, Lightheaded, equal Librium issues from top of stair, I?d fa... Read more
SIDE EFFECTS FROM Pfizer- April 5, 2021, Lightheaded, equal Librium issues from top of stair, I?d fall going downstairs like my muscles would give out or I couldn?t control their movement or lose balance, black outs, fatigue, seeing stars as if I was dehydrated. Muscle tightness in my back, legs, buttocks to the point they would lock up, stop working and the pain would be unbearable walking 10? to 15? (I was up to ½ mile walking prior to this) without any notice and I could not move, I would have to wait 15-20 minutes before I could move or just crawl in pain. Spasms throughout my body I cannot control, previous migraines are more frequent, severe, and so debilitating I would stay in bed up to 6 hours with ice on my neck in pure darkness. My dog would have to poop and pee in the house if my neighbor wasn?t home. This is continuing to this day. More in my hips now than other joints but the muscle tightness continues. The only thing that has gone less frequent to less than once a month is spasms have dissipated (July 2021) in time. At the end of July, 2021, Soft tissue damaged areas on my head started from a motorcycle accident from 2008, became so tender to the touch it was impossible to take a shower, my hygiene is suffering which puts my health in danger. The water touching my head would bring me to tears, I went from showering every day to once a week. I stopped going to the chiropractor because it hurts to be touched. I cannot lay down or sit more than a few minutes at a time, I use Lidocaine mixed with CBD balm all over my body and scalp. Memory fog, forgetfulness, confusion, double vision, major hair loss, bumps on my skin, tender stomach, shortness of breath without humidity and inside with air conditioner on (very rare for me), legs show signs of swelling, tingling, continual extreme numbness in my extremities, I?ve broken all my coffee cups, I?ve tried to get up and have fallen because I didn?t realize my legs were numb after sleeping or sitting. All my joints, bottom of my feet, heels neck shoulders. After going to the bathroom, I?m washing my hands, and if I don?t sit back down on the toilet, I will pee myself immediately. These side effects started around mid- May 2021 and have not gone away and stabbing chest pain on the left shoulder/neck area kinda like cardio spasms around my heart that go away after 15-30 second but excruciating pain happening 2-3 within a week waking me up I started Online Virtual classes in December 2020, one on one weekly courses with a therapist/case manager and weekly group courses , and completed them in June 2021. I elected to Virtual classes due to cancelled bed dates since beginning of 2019 due to COVID. I felt like a new person ready to start ?living for the first time? and get out and into a place with no humidity. Better for my health was my concern. It took watching the news once with massive destruction going on, children being killed by drive by shootings, fires destroying buildings and businesses I once visited, places I?ve where with my sister worked as a hair stylist, and brother used to live when we talked. So much hate, what happened to the world while I was fixing myself to be mentally healthier and vaccinated to be able to rejoin the community again? Since July 2021, I feel like something inside me snapped, broke ? the media coverage, the center misleading or changing COVID reports, leader doing nothing to stop the racism/hate damage control and deaths, has taken away all my hard work away from me! The misunderstanding of COVID, the vaccine side effects has scared to into believing I cannot leave my home, or I will die.
52 2021-07-19 speech disorder Pain is sitting in her left ankle.; Leg muscles sore bilateral on calf, legs and hips; itcy pain; T... Read more
Pain is sitting in her left ankle.; Leg muscles sore bilateral on calf, legs and hips; itcy pain; The first 3 days it was affecting her speech and thinking; The first 3 days it was affecting her speech and thinking; It was front and back like squeezing her brain in between; Dizziness; No appetite; It is really so painful that it is blocking her ability to walk/could not walk because of the pain; Left arm injection site pain; All over body aches; Horrible headache; Sleepiness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number: EW0171, Expiration date: was not reported), via intramuscular in arm left on 27Apr2021 as DOSE 2 single for COVID-19 immunization. The patient medical history included she was having COVID at the end of Oct2020, quite well and she was quite healthy. She was fit and skinny, petite person. She was a healthy eater. The patient read her immunity was probably good for about 6 months. When she was invited to vaccinate, after 6 months of possible immunity, she did. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Batch/Lot number: EW0151, Expiration date: unknown) via intramuscularly in left arm on 06Apr2021 13:00 for covid-19 immunization. The patient stated that she was having COVID at the end of Oct2020, quite well and she was quite healthy. She was fit and skinny, petite person. She was a healthy eater. The patient read her immunity was probably good for about 6 months. When she was invited to vaccinate, after 6 months of possible immunity, she did. On 27Apr2021, the patient received second dose, after the second dose, she was hit hard in 1-2 days after. She had very short but all possible side effects of COVID. She could recognize the symptoms, because she had COVID. On 28Apr2021 at 06:00, the patient had all over body aches, horrible Headache, sleepiness which was further explained as every 4 hours she would have to lie down and pass out and fall asleep. The patient went to bed at 11, woke up at 13:00 and by 15:00 was asleep again. On the same date at 18:00, the patient had dizziness, no appetite; At 09:00, the patient experienced left arm injection site pain and throughout the day. It was not a big deal. She was switching between warm and cold compress. NO emergency room or physician's office required. She was good with pain because she had 3 heavy childbirth deliveries. On 29Apr2021, she would sleep without reason. The day before, she was fine. She would sleep every 3 hours or so. The patient had no appetite on 28Apr2021 through 30Apr2021. On 30Apr2021, she had her first decent meal. She craved Jello like when she was pregnant and cracker or pretzels. That was all she was eating . She lost 6 lbs in a couple of days. She was still not eating well. On 02May2021, she has leg muscles were sore bilateral on calf, legs and hips. It was really so painful that it was blocking her ability to walk. It was like after sports, heavy muscle pain. It was stated that the body aches went down the legs, Just now it was sitting in her left ankle. It was just ice cold, some kind of itcy pain. It was dissolving. It is just in one ankle which was left ankle. That scares her a little because it was her heart side. 03May2021, it was in her entire leg, both sides. It was further clarified that immediately after waking up, she could not walk because of the pain. It was further clarified that she could not stand on legs because of her sore muscles. She described the pain as the same as when you are younger in school and played sports. It was very painful. She was screaming out in pain. On an unknown date in May2021 the patient was able to function in daily activities. The first 3 days headaches was affecting her speech and thinking. It was front and back like squeezing her brain in between. Tylenol only helped. The patient said she got the vaccine for prevention and because both of her 25 year old children live with her. The patient daughter had little bit of fever. Separate report completed for her daughter. They did not have COVID infection. The patient received treatment with one Tylenol 500 mg and that slowly started working on headache, and it lasted 3 days and also received for muscle pain but 7 days after vaccine she has something and also tylenol helps to sleep during the night. Outcome of the events Horrible headache, Sleepiness, Dizziness and Left arm injection site pain was recovering, and not recovered from No appetite, Leg muscles sore bilateral on calf, legs and hips and unknown for other events. No follow-up attempts are needed. No further information is expected.
52 2021-07-20 weakness gastrointestinal symptoms and has been hospitalized following both doses of the covid vaccine.; I wa... Read more
gastrointestinal symptoms and has been hospitalized following both doses of the covid vaccine.; I was hospitalized 2 weeks ago and I've been to the ER 4 times for fluids because I'm so weak; diarrhea; severe pain in my left abdomen; bad taste in her mouth; vomiting/sometimes she throws up her meds; she is seriously exhausted; This is a spontaneous report from a contactable consumer. A 52-years-old(age of vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included gastrooesophageal reflux disease from 2017 and ongoing. There were no concomitant medications. Patient is a 52 year old female consumer, who reportedly experienced gastrointestinal symptoms and has been hospitalized following both doses of the covid vaccine. She reportedly has a specific question about 1 symptom; a bad taste in her mouth, asking if its related to the vaccine and should it be gone by now? She reportedly received the vaccine 2 months ago, no exact dates provided, no lot number as the she reportedly does not have a vaccination card. Patient stated "I could be better" reporting that she has had a bad taste in her mouth for 3 months and every time she has been tested for covid it has been negative. Patient reported that she has GERD and can only eat certain things otherwise she will throw up. She can eat mashed potatoes and gravy, sometimes she throws up her meds. She reports "I have diarrhea, I have severe pain in my left abdomen, I was hospitalized 2 weeks ago and Ive been to the ER 4 times for fluids because Im so weak. I can't barely do anything around the house. She asking, could I have covid or could the bad taste in my mouth be because I have covid even though I tested negative? She asking if having a covid infection could cause a bad taste in her mouth. Attempted to clarify if she had questions about the covid vaccine, she asking about having covid and having a bad taste in her mouth and denied any other questions at this time. No questions about her other symptoms. She reports that her symptoms started 3 months ago, and it was reported that she had the vaccine about 2 months ago but no dates were provided. She asking about symptoms and if they are related to having covid, referred to HCP for evaluation, discussion and guidance. She had both doses of the Covid vaccine shot, was hospitalized two months after having both doses of the vaccines. She confirms details provided by transferring agent. She clarifies she went to the hospital for gastrointestinal issues that started after the doses of the Pfizer Covid vaccine, states she did not have problems with the second shot, states after the first dose she did have some flu like symptoms. Clarifies that she has GERD and states she keeps having abad taste in her mouth and severe pain in left abdomen, diarrhea and vomiting. States she was diagnosed with GERD prior to vaccines but the other symptoms started about 2 months after the vaccines. She does say she has been seeing her gastroenterologist since 2017. States she got the shots done at (withheld) but they are not there anymore so she cannot get a copy of her patient vaccination record card. States she received the first dose 2-3 months ago. Unknown exact dates. She states she has been to the emergency room 4 times about her symptoms and was admitted to the hospital for a week about 2 weeks ago. Exact dates unknown. States the surgeon said there was nothing he could do for her. NDC, Lot, Expiration dates, dosages unknown, She does not have patient record card. She states she is seriously exhausted. She wants to know specifically if the bad taste in her mouth should be gone by now if it is caused by the vaccine. Outcome was unknown for fatigue and not recovered for other events. Treatment received for weakness. Information about batch/lot number has been requested.
52 2021-07-20 muscle spasms experienced a period; cramping; back pain; premenopausal; abdominal pain; This is a spontaneous repo... Read more
experienced a period; cramping; back pain; premenopausal; abdominal pain; This is a spontaneous report received from a contactable female consumer (patient). A 52-year-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot Number: EW0167) via an unspecified route of administration in the arm left on 13May2021 as dose 1, single for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing She called her health department this morning because her husband tested positive for Covid yesterday. The patient's concomitant medications were not reported. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Prior Vaccinations (within 4 weeks) any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. On 13May2021, about 4-5 hours after she experienced a period, cramping. On unknown date, May2021 experienced abdominal pain. She is pre-menopausal and previously has not had a period in 6 months. However, she heard on the news that other women were getting a period after receiving the vaccine. A couple weeks, later she began to experience back pain that has not subsided. Has sought treatment from gynaecologist and has upcoming appointment with gastroenterologist. Received second dose of vaccine on 03Jun2021. She stated that she had been fully vaccinated, received her vaccines 13May2021 and the second either 02Jun2021 or 03Jun2021, and it was LOT EW0202 she thinks, or it could be, it is hard to read, EW0702 also but it's one of those two. Both were in the left arm. It was about 11:30 am both times in the morning or so. She has been fully vaccinated for a month and called her health department this morning because her husband tested positive for Covid yesterday. No additional details provided. The health department told her to call Pfizer and talk to Pfizer first about whether it is coincidental or not after the first shot on 13May2021. She went to get checked by her gynaecologist and did tests and ultrasounds. She said she thought it might be inflammation which is common once you get the Covid shot and that could possibly be causing this, and nobody seems to know. The cramping is constant and abdominal pain now. Sometimes it is like cramping and sometimes a dull weird pain. That kind of cleared up after 4 or 5 days and then she had not had another one until yesterday when this started again. She thinks maybe it is partly because she is pre-menopausal. Lower back pain did not start right away and did not notice it until a couple of weeks ago, it is still going on and has everything now. Abdominal pain is worse, it's kind of is mid to lower abdomen pain and seems worse like on the left side. She saw her gynaecologist and they did not do a pap smear because she is not due for it. They did a physical and a pelvic ultrasound and they had that imaging and did not find anything. It was on 22Jun2021. She also felt her ovaries and uterus, and everything felt fine. The adverse event required to visit to physician office. She had an appointment scheduled since she eliminated gynaecological issues, scheduled for the gastroenterologist but can't go until 03Aug2021. She tries not to take pain medication but took Ibuprofen a couple of time is all. The patient underwent lab tests and procedures which included ultrasound pelvis resulted as normal on 22Jun2021. The outcome of the events was unknown.
52 2021-07-20 tingling, numbness numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and... Read more
numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and the right side of my face; jaw ache to the right side of my jaw; This is a spontaneous report from a contactable nurse, the patient. A 52-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in left arm on 27Mar2021 at 12:00 (age at vaccination was 52 years) as a single dose for COVID-19 immunisation. The patient medical history included history of anaphylaxis. The patient was allergic to latex, bananas and melons. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 27Mar2021 at 12:30, starting 20-30 minutes after injection, the patient began to feel numbness and tingling to her lips and the right side of her face. When she returned home, she took a BENADRYL with some relief. However, since then the face and lip tingling had persisted intermittently and she had a jaw ache to the right side of her jaw. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 30Mar2021, the patient underwent abbott binax nasal swab test for COVID-19 and the report was negative. The clinical outcome of the events numbness and tingling to lips and the right side of face and jaw ache to the right side of jaw was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
52 2021-07-21 numbness, tingling My extremities were numb and tingling and I could not stand without falling over.; I was unable to s... Read more
My extremities were numb and tingling and I could not stand without falling over.; I was unable to shower or work; I lost balance to the point of feeling like vertigo for 9 days; I lost balance to the point of feeling like vertigo for 9 days; My extremities were numb and tingling and I could not stand without falling over.; My extremities were numb and tingling and I could not stand without falling over.; scared; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received first dose of bnt162B2(PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302) via unspecified route of administration on Left arm on May2021 (at 52-years of age) as Dose 1, single for COVID-19 immunization. Medical history included allergies to tomatoes, allergies to many antibiotics (unspecified) and Possibly Covid in autumn of 2020, hair fell out in chunks & had a skin rash, had a terrible time sleeping because of nervousness. She didn't have respiratory issues but in hindsight think it may have been Covid. The patient has not received any other vaccine in four weeks. The patient has not received other medications in two weeks. Device timestamp was reported as 06Jul2021. Concomitant medications were not reported. Known allergies included many antibiotics, tomatoes. No Covid prior vaccination nor post vaccination reported. No other vaccine administered in four weeks and other medications in two weeks. It was reported that "I lost balance to the point of feeling like vertigo for 9 days. My extremities were numb and tingling and I could not stand without falling over. This was after the 1st dose and I am too scared to take the 2nd dose. I was unable to shower or work and want to know what to do about a 2nd vaccination". No treatment received for AE's. Outcome of the event was recovered on 2021. Information about lot/batch number has been requested.
52 2021-07-21 tingling, numbness April 15 about 5 minutes after vaccination I noticed my left hand was going numb and They asked me t... Read more
April 15 about 5 minutes after vaccination I noticed my left hand was going numb and They asked me to wait 30 extra min for observation during that time my face started tingling they said to go home and take Benadryl at home my foot started to feel numb I called an urgent care and they said to go to an ED were they only did an cat scan to rule out a blood clot then they sent me home. I'm still experiencing symptoms some heavy breathing fatigue and muscle fatigue and the the tingling.
52 2021-07-22 facial pain, tingling, numbness, bell's palsy Right side of face numb and tingling. Vision blurred in right eye. Pain in face. Diagnosed with B... Read more
Right side of face numb and tingling. Vision blurred in right eye. Pain in face. Diagnosed with Bells Palsy
52 2021-07-22 hot flush Non-stop hot flashes (day and night) since the jab; Headache; Warmth at the injection site; Sorenes... Read more
Non-stop hot flashes (day and night) since the jab; Headache; Warmth at the injection site; Soreness at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 52-yeasr-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727) via an unspecified route of administration in the arm left on 20Mar2021 at 15:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The concomitant medication were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Sep2020, the patient underwent COVID test (nasal swab test) and resulted negative. On 17Dec2020, the patient underwent COVID test (nasal swab test) and resulted negative. Since the vaccination, on an unknown date in 2021, the patient had been tested for COVID-19 and result was unknown. On 20Mar2021 the patient experienced non-stop hot flashes (day and night) since the jab, headache on the day of the vaccine, warmth and soreness at the injection site for a couple days. Therapeutic measures and treatments were not taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events hot flashes, headache, warmth and soreness were not recovered. at the time of this report. No follow-up attempts are needed. No further information is expected.
52 2021-07-22 numbness persistent headaches, confusion, brain slowing(cant process info effectively) numbness and dizziness
52 2021-07-22 tingling I had tingling sensation on my left cheek, back of my neck, around my mouth and hands and feet; I ha... Read more
I had tingling sensation on my left cheek, back of my neck, around my mouth and hands and feet; I had tingling sensation on my left cheek, back of my neck, around my mouth and hands and feet; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 12Mar2021 at 08:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies. The patient had allergies to penicillin, latex, environmental, wheat and a few others. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021, the patient experienced tingling sensation on left cheek, back of neck, around mouth and hands and feet, which lasted almost until second dose. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event tingling sensation on left cheek, back of neck, around mouth, hands and feet was recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-07-22 speech disorder the right side of my neck swelled up; I could not speak or think properly; I could not speak or thin... Read more
the right side of my neck swelled up; I could not speak or think properly; I could not speak or think properly; blood pressure was 177 over 80 and kept going up/got to 205 over 100 and they took me to the hospital and it took 3 hours for it to get to a reasonable number of 149 over 80/blood pressure this high; feeling bad; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: er2613), via an unspecified route of administration on 23Mar2021 12:15 (at the age of 52-years-old) at dose number unknown, single in the left arm for COVID-19 immunisation. Medical history included corn allergy and asthma. The patient was allergic to lots of products in the store. The patient has a safe list from her dermatologist so she knows what kind of shampoo, clothes detergent, etc. she can buy. The patient had no COVID prior vaccination, was not tested for COVID post-vaccination, and was not pregnant at the time of vaccination. Concomitant medications included losartan and citalopram. The patient previously took lisinopril, lactose, and ammonia, and experienced allergies. The patient was vaccinated in a public health department. On 23Mar2021 12:15, the patient started feeling bad immediately. The patient stated, " they asked me to back up and I went left and ran over an orange cone that got stuck under my Prius because I misunderstood them". On 23Mar2021 12:15, the patient's blood pressure was 177/80 and kept going up. The patient's blood pressure got up to 205/100. The patient was brought to the hospital on 23Mar2021 and it took 3 hours for it to get to a reasonable number of 149/80 so the patient could go home. The patient never had her blood pressure this high. The patient was not anxious about getting the shot at all and felt normal before hand and these all happened very quickly. The patient will not get the second dose because she doesn't want to have a stroke. The next morning, on 24Mar2021, the patient's right side of her neck swelled up and she could not speak or think properly. It was reported that the events resulted in emergency room/department or urgent care visit. It was unknown if patient was given treatment for the events. Outcome of the events blood pressure high was recovered on 23Mar2021, and for other events was recovered on an unspecified date in 2021. Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.
52 2021-07-23 pain in extremity My left arm where the injection was had swollen three times the normal size; Swelling; Dizzy; I used... Read more
My left arm where the injection was had swollen three times the normal size; Swelling; Dizzy; I used cold compress to stop itching and swelling; Lymphadenopathy; Arm Pain; Vomiting; Headache; Diarrhea; Muscle pain; Joint Pain; Nausea; Rash at the injection site; rash on the arm; Fever of 99.9; Fever of 101; This is a spontaneous report from a Contactable Consumer reported for self. This 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Arm Left on 28Jun2021 17:00 at the age of 52-year-old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included COVID. Concomitant medication included hormone medication, It is Best 3 milligram, T 2 Milligram topical cream (Name not confirmed hence not captured in tab) and taking Progesterone 200mg. She felt great for 12 hours, like 5 O' Clock the next day (29Jun2021 5:00) left arm where the injection was had swollen three times the normal size. She had started getting a fever of 99.9 (29Jun2021) and she started getting dizzy, nausea, vomiting and diarrhea. It persisted for 14 days, the swelling on 29Jun2021, the headache, the muscle pain, the joint pain, the fever of 101 and the rash at the injection site and the lymph node, lymphadenopathy, diarrhea, vomiting and arm pain on 29Jun2021. So, every side effect that was documented as a side effect, had a rash on the arm that look like a flower and its incitingly. Treatment included took Benadryl to stop swelling but don't know if it helped, it took 4 days for the swelling to stop and used cold compress to stop itching and swelling. Lab data included had a full hormone panel and CBC Diffs (Unclear and not clarified) test were normal. Cholesterol and sugar were great, everything was great, except hormone. Outcome of the event Arm Pain, Lymphadenopathy, Rash at the injection site; rash on the arm, Joint Pain, Muscle pain, Headache, Diarrhea, Vomiting, Fever of 99.9; Fever of 101, Swelling was recovered in Jul2021. Outcome of other events was unknown. Information on the lot/batch number has been requested.
52 2021-07-25 pain in extremity Upon shot being administered into left arm, Immediate sensation of dripping down left arm;; increas... Read more
Upon shot being administered into left arm, Immediate sensation of dripping down left arm;; increasing pain; frozen shoulder; loss of range of motion; constant pain since shot. Shot#2 in right arm had minor pain at site that went away in a few days.
52 2021-07-25 tenderness, muscle spasms Left arm was tender, lymph node under arm begin to get bigger the size of a golf ball, left leg feel... Read more
Left arm was tender, lymph node under arm begin to get bigger the size of a golf ball, left leg feels as though there is a continous charlie horse there.
52 2021-07-26 numbness On February 7th at 11:00 at night I started throwing up and had a little diarrhea had stomach pain a... Read more
On February 7th at 11:00 at night I started throwing up and had a little diarrhea had stomach pain all through the night and at 6:00 the next morning February 8th I went to Paulding hospital where they said that I had a heart attack not sure if it was due to the covid shot that was given a couple weeks before since the hospital I have had different symptoms of numbness in the left two fingers and headaches and visual issues as well
52 2021-07-27 weakness, feeling hot The evening that I received my shot, I started to feel heat under my feet and hands, heat all over m... Read more
The evening that I received my shot, I started to feel heat under my feet and hands, heat all over my body, joint pain/swelling. sensitivity to heat/cold, tingling on my tongue, weakness, headaches and nausea. It's been 3 weeks since my first vaccine, and I'm still having the same symptoms.
52 2021-07-27 discomfort, tension headache I have a lot of pressure in my face, under my eyes (from the left side of my face to my right). Also... Read more
I have a lot of pressure in my face, under my eyes (from the left side of my face to my right). Also pressure around my nose, it's very tender on both side. My entire face feels tight and has a lot of; I have a lot of pressure in my face, under my eyes (from the left side of my face to my right). Also pressure around my nose, it's very tender on both side. My entire face feels tight and has a lot of; I have a lot of pressure in my face, under my eyes (from the left side of my face to my right). Also pressure around my nose, it's very tender on both side. My entire face feels tight and has a lot of; This is a spontaneous report from a contactable consumer (patient herself). This 52-year-old female consumer (patient) reported for herself that received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation was Solution for injection, Lot Number: EW0196), dose 1 via intramuscular in left Arm on 18-JUN-2021 14:30, as single dose for COVID-19 immunization (age at time of vaccination 542 years). The patient was not pregnant. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19 Prior to vaccination, Since the vaccination, has the patient been tested for COVID-19 as no. The patient medical history included Allergies, Asthma. The patient concomitant medications included DHEA, Pregnenolone, Iron, Calcium, Multi, Calciferol (Vit D). On 19Jun2021 patient experienced a lot of pressure in face, under her eyes (from the left side of her face to right). Also, pressure around her nose, it was very tender on both sides. Her entire face felt tight and has a lot of pressure. The patient had allergies to Sulfa, Ceclor, Amoxicillin, Tetracycline, Wheat, Soy, Yeast, and she was not taking any treatment. The outcome of all events were not recovered. Follow-up attempts completed. No further information expected.
52 2021-07-27 discomfort Extremely uncomfortable; Difficult to sleep; Joints became painful; Stiff joint; Inflamed joints; Th... Read more
Extremely uncomfortable; Difficult to sleep; Joints became painful; Stiff joint; Inflamed joints; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 03Apr2021 at 00:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included sore joints since caught COVID in Mar2020 and COVID-19 in Mar2020. The patient had no known allergies to medications, food, or other products. Concomitant medications included fish oil (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and cannabidiol (CBD OIL); all taken for unknown indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 14:00, the patient experienced most of the joints became painful, stiff and inflamed all night, making it difficult to sleep. On 04Apr2021, 22 hours after getting first vaccine shot, the patient was extremely uncomfortable. After the patient took the vaccine, her joints felt notably far more painful, more like they felt last spring and summer at their worst. The patient stated her joint problem was likely a COVID long-hauler condition. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events most of the joints became painful, stiff and inflamed all night, making it difficult to sleep and extremely uncomfortable was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
52 2021-07-27 facial pain, pain in extremity, tremor pain on my arm; nausea; shaking, tremors; low grade fever; stomach upset; mild sore throat; moderate... Read more
pain on my arm; nausea; shaking, tremors; low grade fever; stomach upset; mild sore throat; moderate body aches; high intensity pain on the right neck (sameside as vaccine), very difficult to turn head side by side because of pain on neck; intense pain on armpit; pain on half of the face (opposite side of vaccine); pain on half of the face (opposite side of vaccine) and left ear; This is a spontaneous report from a non-contactable other healthcare professional. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm right on 29Mar2021 at 08:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 22:00, after the second dose, the patient experienced pain on the arm, nausea, shaking, tremors, low grade fever, stomach upset, mild sore throat, moderate body aches, high intensity pain on right neck (same side as vaccine), very difficult to turn head side by side because of pain on the neck, intense pain on armpit that lasted a full week from monday to sunday. The patient also had pain on half of the face (opposite side of vaccine) and the left ear only during the first night after vaccine. The patient did not receive any treatment for the events. The clinical outcome of the events pain on the arm, nausea, shaking, tremors, low grade fever, stomach upset, mild sore throat, moderate body aches, high intensity pain on right neck (same side as vaccine), pain on half of the face (opposite side of vaccine) was resolved on an unknown date in 2021 and that of intense pain on armpit was resolved on 04Apr2021 and the clinical outcome of left ear pain was resolved on 30Mar2021. No follow-up attempts are needed. No further information is expected.
52 2021-07-27 numbness This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 15Mar2021 at 12:00 hours (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. Concomitant medications included kirkland aller-fex (MANUFACTURER UNKNOWN), glucosamine (MANUFACTURER UNKNOWN), both drugs started on an unknown date for unknown indication. Past medications were not reported. The patient had an allergy to contrast dye. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within four weeks prior to the vaccination. On 15Mar2021 at 12:50, the patient experienced the left side of the face went numb (numbness in the face). The patient took the vaccine at 12:00 hours and waited about 40 mins in the hospital. Then she noticed the left side of her face went numb about 10 mins after leaving the hospital. Lasted for 24 hours. The patient did not have any trouble breathing and did not seem like she needed to return. The patient did call hospital to notify of the reaction and also with the primary doctor office. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event numbness in the face was recovered on 16Mar2021, after the duration of 24 hours. No follow-up attempts are possible. No further information is expected.
52 2021-07-27 migraine Migraine; Dizziness; Headache; This is a spontaneous report from a contactable consumer (Patient). A... Read more
Migraine; Dizziness; Headache; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in Arm Right on 14May2021 (at the age of 52-year-old) as dose 1, single for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, allergy to artificial sugars. Concomitant medications included celecoxib (CELEXA) taken for an unspecified indication, start and stop date were not reported; topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. On 16May2021, the patient experienced migraine, dizziness, headache. Patient was not informed about the vaccine containing artificial sugars and she mentioned that she is allergic to all types of artificial sugars. When asked for side effects, consumer stated, "Yes, I get migraines from the artificial sugars and I have been suffering from the migraine since I got the shot along with the dizziness but I don't know it's just a typical side effect of the shot but yeah I have been getting migraine". Consumer stated, "It's probably, I would say may be 16May, I don't think I got the headache right away but on 16 definitely it went really bad." The patient underwent lab tests and procedures which included full blood count: unknown date. Therapeutic measures were taken as a result of events included maxalt. The outcome of the events were unknown. Information on Lot/Batch number was available. Additional information has been requested
52 2021-07-27 pain in extremity I can not move my arm pain traveling up and down arm into back area.; This is a spontaneous report f... Read more
I can not move my arm pain traveling up and down arm into back area.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 30Mar2021 at 16:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder not otherwise specified (thyroid problem) started on an unknown date. Concomitant medications included loratadine (CLARITIN) and levothyroxine (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown dates. The patient previously received aspirin on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 08:00 the patient was not able to move her arm, pain traveling up and down arm into back area. The patient consulted the doctor for which he said this was normal but the patient was not sure about it. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event can not move her arm pain traveling up and down arm into back area was not recovered at the time of this report. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
52 2021-07-27 pain in extremity Unable to bring arm above shoulder height; Very painful arm/shoulder like; Very painful arm/shoulder... Read more
Unable to bring arm above shoulder height; Very painful arm/shoulder like; Very painful arm/shoulder; like a pull muscle; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an unspecified route of administration in the right arm on 23Dec2020 at 17:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy. It was reported that patient was healthy. It was reported that patient received other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 20:00, the patient experienced pain upon movement, shoulder pain, painful arm and pulled muscle. The patient described that as very painful arm/shoulder like, no soreness but more like a pull muscle for two and half days and unable to bring arm above shoulder height. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse event. The clinical outcome of the events pain upon movement, shoulder pain, painful arm and pulled muscle was recovered on an unknown date in Dec2020. No follow-up attempts are needed. No further information is expected.
52 2021-07-27 tingling, feeling hot Headache; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a... Read more
Headache; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; a red lump with swelling, then itchy traveling redness around the arm, hot to the touch; hot to the touch; pain and soreness on the injection site and arm; dry mouth; very thirsty; nauseouseness; some Pins and needless on my left arm/hand,face, neck and torso; Fatigue were I need to lay down and sleep; Mild shortness of breath like if I've been running and need to stop and catch my breath; Some mild diarrhea; This is a spontaneous report from a contactable consumer(patient). A 52-year-old non pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EN6200), via an unspecified route of administration on 05Mar2021 at 13:30 (at the age of 52-year-old) into left arm as a single dose for COVID-19 immunization at Public Health Clinic. The patient medical history Rheumatoid Arthritis, Fibromyalgia, Spinal Disk Compression. Concomitant medication(s) included calcium; levothyroxine; multivitamin. The patient had allergies to Penicillin, Sulfate Drugs, NSAIDS, Latex. The patient previously took Percocet, codeine and experienced allergy. On 05Mar2021 at 09:30 PM, the patient experienced Headache, a red lump with swelling, then itchy traveling redness around the arm, hot to the touch, pain and soreness on the injection site and arm, also dry mouth, very thirsty, some nauseouseness and some Pins and needles on my left arm/hand, face, neck and torso. Fatigue where she needs to lay down and sleep. Mild shortness of breath like if she has been running and need to stop and catch my breath, and Some mild diarrhea. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment medications were received for the adverse events. The outcome of the evens was recovering. No follow-up attempts are possible. No further information is expected.
52 2021-07-27 tremor Fever for 3 days reaching 103.4; chills; sweats; shaking; headache; Hard lump on left arm size of ba... Read more
Fever for 3 days reaching 103.4; chills; sweats; shaking; headache; Hard lump on left arm size of baseball that has not gone away.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 52-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, solution for injection, batch/lot number: unspecified), via an unspecified route of administration in left arm on 28Feb2021 at 16:30 (age at the time of vaccination 52-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She had no known allergies. No other medications in two weeks. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unspecified), via an unspecified route of administration in left arm on 07Feb2021 as historical vaccination as single dose for COVID-19 immunisation. On 01Mar2021 at 08:00, the patient experienced fever for 3 days reaching 103.4, chills, sweats, shaking, headache and hard lump on left arm size of baseball that has not gone away. The patient had neither COVID prior vaccination nor COVID tested post vaccination. No treatment received for adverse events. The outcome of the adverse events was not recovered. No follow-up attempts are needed. information about lot/batch number could not be obtained. No further information is expected.
52 2021-07-28 weakness Felt like being in a fog; Dizziness; Very weak; Tiredness; Bad headache; Muscle pain; Chills; Fever ... Read more
Felt like being in a fog; Dizziness; Very weak; Tiredness; Bad headache; Muscle pain; Chills; Fever from 100 to102.7 for 10 hours; Severe joint pain; Nausea; Swollen lymph nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 17:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and hypothyroidism. The patient had a history of allergy to sulfa. The patient had received medication within two weeks of vaccination which were unspecified. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 17:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 17:45, the patient experienced tiredness, bad headache, muscle pain, chills, fever from 100 to102.7 (units not specified) for 10 hours, severe joint pain, nausea, swollen lymph nodes, dizziness, very weak and felt like being in a fog. The symptoms went on for 72 hours and reported that 108 hours after the 2nd dose the patient still felt very tired and had a few aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events tiredness, bad headache, muscle pain, chills, fever, severe joint pain, nausea, swollen lymph nodes, dizziness, very weak and felt like being in a fog was recovering at the time of report. No follow-up attempts are needed. No further information is expected.
52 2021-07-28 pain in extremity revealed a sudden onset of gastric ulcers; Sweats; Sore arm; bladder leakage; Swelling joints/Inflam... Read more
revealed a sudden onset of gastric ulcers; Sweats; Sore arm; bladder leakage; Swelling joints/Inflammation issues in my joints and back; Cluster rash began on left leg/I have patch pop up now either on my arms, trunk or legs; inflamed flat clusters all over the front side of my body, which then turned into pustules or blisters all over me and then flat red vesicular spots; It is annoying, itches and unsightly at times; stomach bloating; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EP9534), dose 1 via an unspecified route of administration, administered in Arm Left on 20Mar2021 10:59 (at the age of 52-Years-old) as single dose for COVID-19 immunisation. Medical history included lyme disease and methylenetetrahydrofolate reductase gene mutation from an unknown date and unknown if ongoing (verbatim: Lyme/ Mutated Mthfrgene). The patient's concomitant medications were not reported. The patient experienced revealed a sudden onset of gastric ulcers, sweats, sore arm, bladder leakage, swelling joints/inflammation issues in my joints and back, cluster rash began on left leg/i have patch pop up now either on my arms, trunk or legs, inflamed flat clusters all over the front side of my body, which then turned into pustules or blisters all over me and then flat red vesicular spots, it is annoying, itches and unsightly at times and stomach bloating on 20Mar2021. AE resulted in doctor or other Health care Professional office/ clinic visit. Since then, patient have consulted with 3 different doctors. None of which has ever seen anything like it other than some other patients that also received the vaccine. All of which recommended that I do not get the second vaccine. Since the outbreak, which mirrors on each side of the body, daily I have patch pop up now either on my arms, trunk or legs. It ranges from patch like or pustule. It will last a few hours and then disappear. Patient had none of this until I took the first dose of Pfizer. Patient have been to a dermatologist and he is afraid to prescribe me anything because he isn't sure exactly what reaction it could have with the unknowns of the vaccine. No Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination. No other vaccines received within one month prior to the date listed in item 4. Patient ever had no any adverse event following any previous vaccine. Exclusive quality of pruritic Pustule (1 week - now I get patches ) vesicular last one month. Between shows the white spots prior to vesicular stage. Patient would like to know what to do, as I have seen similar reports online, that others have had to had reached out and want a solution. Any clue of what it could be. How to treat. How long it will last. Will I have this for the rest of my life. Is Pfizer willing to pay my medical bills to figure out what long term effects I have and how it will impact my life. Will you send me a vaccine card that will approve me for travel based on the one shot and my reaction. Am I forever quarantined to live within a bubble. I'd like some answers and some help in getting my health back on track. My children have seen what I went through as have many of my friends and not one of them will get the shot after they saw the impact it has had on me. By the way whatever happened to the flu. I need of answers and help to get me back to good health. The outcome of the reported event sudden onset of gastric ulcers and stomach bloating was unknown and for remaining events the outcome was not recovered. Follow-up attempts are needed. Further information is requested.
52 2021-07-28 tingling, pain in extremity, weakness, numbness facial numbing, tingling which began 20 min after shot second dose, same response that did not dissi... Read more
facial numbing, tingling which began 20 min after shot second dose, same response that did not dissipate after second dose many additional sx appeared over next 2 -3 months which included erratic BP, pain and tingling in legs, dizziness, body weakness
52 2021-07-28 unresponsive to stimuli Patient tested positive for COVID on 12/16/2020. Patient received both doses of the Pfizer COVID vac... Read more
Patient tested positive for COVID on 12/16/2020. Patient received both doses of the Pfizer COVID vaccine on 01/14/2021 and 02/04/2021, and again tested positive for COVID on 03/26/2021. She was transferred from outside medical facility to Medical Center on 03/28/2021 due to concerns over new COVID infection and cellulitis. Patient was found unresponsive and not breathing the morning of 03/30/2021 and died at 5:34AM from cardiac arrest.
52 2021-07-29 tingling, numbness 25 minutes after injection, left side of face was numb; loud tinnitus; severe pain in left neck, jaw... Read more
25 minutes after injection, left side of face was numb; loud tinnitus; severe pain in left neck, jaw, and shoulder; severe pain in left neck, jaw, and shoulder; severe pain in left neck, jaw, and shoulder; numb tingling in face and tongue, in both legs below knees, both feet, both arms below elbow and both hands; numb tingling in face and tongue, in both legs below knees, both feet, both arms below elbow and both hands; numb tingling in face and tongue, in both legs below knees, both feet, both arms below elbow and both hands; numb tingling in face and tongue, in both legs below knees, both feet, both arms below elbow and both hands; numb tingling in face and tongue, in both legs below knees, both feet, both arms below elbow and both hands; numb tingling in face and tongue, in both legs below knees, both feet, both arms below elbow and both hands; numb tingling in face and tongue, in both legs below knees, both feet, both arms below elbow and both hands; bouts of brain fog; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EW0179-H), dose 1 via an unspecified route of administration, administered in Arm Left on 05Jun2021 11:45 as DOSE 1, SINGLE for covid-19 immunisation. Patient medical history included Migraines 1-2x/month from an unknown date and unknown if ongoing. The concomitant medication was not reported. Not known allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jun2021 12:15 PM patient experienced 25 minutes after injection, left side of face was numb, loud tinnitus, severe pain in left neck, jaw, and shoulder; few days later, numb tingling in face and tongue, in both legs below knees, both feet, both arms below elbow and both hands; bouts of brain fog and muscle aches; all described symptoms have persisted for 7 weeks without stopping. The patient underwent lab tests and procedures which included laboratory test: unknown results, magnetic resonance imaging: unknown results on an unspecified date. Ae resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with Antiviral medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.
53 2021-01-02 tenderness I noticed swelling of the lymph nodes under my left armpit, when i called my doctor's office the nur... Read more
I noticed swelling of the lymph nodes under my left armpit, when i called my doctor's office the nurse told me to put ice for 20 minutes. Ice was applied every day for 20 minutes, the swelling finally went down some today but the vein under my left arm is still tender.
53 2021-01-03 flushing Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness,... Read more
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
53 2021-01-03 tingling Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongu... Read more
Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongue. Pt given 10mg cetirizine. Pt observed for 30 minutes. Pt states feeling are resolved. Pt released to work.
53 2021-01-03 tremor pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 ... Read more
pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 hours after vaccine. Resolved in 5 days.
53 2021-01-04 weakness The next day 12/18 felt weak, fatigue and had to rest in between my activities. I exp headaches for ... Read more
The next day 12/18 felt weak, fatigue and had to rest in between my activities. I exp headaches for 2 days and on 12/20 feeling 100 ft walk was tired. Then on 12/21 started my exp body ache lasted 2 days. I spoke with my PCP and had a appt on 12/28. On 12/31 it felt as of my symptoms was subsiding. I started feeling better on 1/2/21. I missed 6 days of work.
53 2021-01-04 feeling hot, muscle spasms Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her l... Read more
Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her left trapezius, and headache. She experienced a warm sensation travelling down her left arm. She described a feeling of muscle spasms in her left upper and lower extremity and was unable to bear weight on her left lower extremity due to the altered sensation. She endorsed acute nausea and vomiting. She was transferred from vaccine clinic to emergency department at 1420. Patient received diphenydramine 12.5mg IV @ 1722, prochlorperazine 10mg IV @1733, Lactated Ringers 250mL IV bolus @ 1733, ondansetron ODT 4mg @1445. Patient was diagnosed with an acute anxiety attack in the setting of a novel vaccine administration. She was discharged at 1854.
53 2021-01-04 feeling hot Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 ... Read more
Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 sec; with in 5 minutes of inoculation experienced an odd taste in my mouth; Warm sensation in Left upper arm for at least 15 minutes.; This is a spontaneous report from a contactable other Health Care Professional (HCP). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 at 13:15 (at the age of 53-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included pneumonia, high cholesterol, eczema rashes from perfumes/beauty products/soaps and hand dermatitis all on unknown dates.The patient is allergic to amoxicillin (rash trunk) and experiences seasonal allergies in the eyes/nose/with coughing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 13:20 (reported as "within 5 minutes of inoculation") the patient experienced an odd taste in her mouth, a pounding heart rate felt in her chest that lasted less than 30 seconds (may have been shorter). She stated that she was trying to stay calm. Also, she experienced a warm sensation in the left upper arm for at least 15 minutes as well as a very painful shoulder twenty-four hours later; there was no swelling nor redness noted. Her shoulder was much improved by the third day.The patient did not receive any treatment for the events. The clinical outcomes of heart rate increased, taste peculiar, localized feeling of warmth and shoulder pain were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
53 2021-01-04 flushing heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrena... Read more
heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrenaline rush; Nasal congestion started after 30 min; within 3 min after injection, became flushed; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 19Dec2020 07:30 AM at left arm, at single dose for covid-19 immunization. Medical history included Type 1 diabetes, hx of anaphylaxis to allergy shots and allergies to Latex, avocados, fluorescein dye (anaphylaxis), cats/dogs, environmental. Concomitant medication included ascorbic acid (VIT C), ergocalciferol (VIT D), fexofenadine hydrochloride (ALLEGRA), insulin lispro (HUMALOG), tocopherol (VIT E). The patient was not pregnant at the time of vaccination. Within 3 min after injection, the patient became flushed from 19Dec2020 07:33 AM; heart began racing, dizziness, lightheaded, felt foggy, became winded/short of breath and felt an adrenaline rush, was observed by med personnel x 30min from 19Dec2020 08:00 AM. Nasal congestion started after 30 min on 19Dec2020 08:00 AM. No treatment was received for all events. These events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
53 2021-01-04 flushing it made me turned flushed, really almost purple/ My face was red, arms were red, my neck was red; Sw... Read more
it made me turned flushed, really almost purple/ My face was red, arms were red, my neck was red; Sweating; The initial case was missing the following minimum criteria: adverse event nos. Upon receipt of follow-up information on (27Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EH9899, expiry date not reported), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included metoprolol, hydrochlorothiazide, and lisinopril; all from unspecified dates for blood pressure high. The patient verbalized, "I had the vaccine on last Monday be 21st. I had an issue and ended up in the ER. It made me turned flushed, really almost purple, no anaphylactic nothing, just sweating, my face was red, arms were red, my neck was red but that is it. They gave me Pepcid and Benadryl in ER and watched me in the ER for about 40 minutes. I work at the hospital and I got it from them. I was fine the rest of the week, Thursday, my son came by to pick up a couple of holiday gifts only saw him for 5 minutes. He has now tested positive for COVID. We had masks on. I hugged him on his way out. He took the gifts and left. He is at home now. He got tested yesterday positive for COVID. My question is am I still at risk of getting it from that meeting after I only had one shot?" On an unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: 133/85 and body temperature: 97.9. Therapeutic measures were taken as a result of the events that included Pepcid and Benadryl. Clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
53 2021-01-04 pain in extremity a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced s... Read more
a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced sharp pain in left ear radiating down to jawline and left shoulder and upper arm. Pain also caused severe headache relieved with high dose Tylenol. Symptoms lasted 24hrs. Headaches became mild lasted thru day of report reaction (1/4).
53 2021-01-04 pain in extremity Very sore arm; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pr... Read more
Very sore arm; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the right arm on 28Dec2020 08:30 at a single dose for COVID-19 immunization at the hospital. Medical history included hypertension (HTN) and diabetes mellitus (DM). The patient has no known allergies. The patient had received unspecified other medications the patient received within 2 weeks of vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very sore arm on 28Dec2020 12:00. Outcome of the event was not recovered. No treatment was given for the event. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The event was assessed as non-serious.
53 2021-01-04 tingling, numbness Numbness and tingling in fingers and hand of same arm the vaccine was given in.
53 2021-01-04 tingling feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on th... Read more
feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on the Right side of shoulder and up into neck and ear; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; pain in right shoulder and back of neck into back of head; This is a spontaneous report from a contactable nurse for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), intramuscular on 30Dec2020 10:15 at single dose on right arm for covid-19 immunisation. Medical history included hypothyroid, migraines and sulfa allergy. Concomitant medications included propranolol, topiramate (TOPAMAX), levothyroxine, bupropion hydrochloride (WELLBUTRIN) and levocetirizine dihydrochloride (XYZAL), all from unknown date for unknown indication. At 10:30 on 30Dec2020 (also reported as "about 5 minutes after shot"), patient started feeling tingling on right side of tongue and part of inside of mouth. Felt some light tingling on the Right side of shoulder and up into neck and ear. The tingling resolved, but few hours after the shot, have pain in right shoulder and back of neck into back of head. No treatment was received for the events. Action taken in response to the event was not applicable. Outcome of feeling tingling on right side of tongue and part of inside of mouth, felt some light tingling on the Right side of shoulder and up into neck and ear was resolved. Outcome of pain in right shoulder and back of neck into back of head was unknown.
53 2021-01-04 tremor Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Withi... Read more
Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Within 5 minutes of receiving it, serial blood pressure readings began rising, her arm felt heavy, and she developed an uncontrollable tremor primarily in her left arm with what appears to be generalized shivering. Associated with significant anxiety. She has never had an allergic reaction before. No associated shortness of breath or wheezing. No lip tongue or throat swelling. No pruritus or hives. No nausea or vomiting. She was treated for possible dystonic reaction initially with two doses of Benadryl 25mg IV, then 1mg of IV lorazepam, and finally 125mg solumedrol. Symptoms improved significantly with Benadryl, and then resolved entirely after lorazepam. She was discharged home to complete 4 more days of 50mg prednisone.
53 2021-01-05 weakness Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and w... Read more
Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events "tested positive for COVID after receiving the vaccine" was not recovered. Information on lot/batch number has been requested.
53 2021-01-05 numbness associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of visi... Read more
associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of vision problems and numbness to entire body. Benadryl 25mg PO given at 1106. VS: BP 149/122, oxygen 90%, and HR 77 at 11:14 1119: 186/116, HR 79, and oxygen 95%. 1123: 206/102, HR 89, oxygen 96% 1125: EMS called.
53 2021-01-05 pain in extremity In the end of December she developed right wrist pain and some mild swelling, then pain in both arms... Read more
In the end of December she developed right wrist pain and some mild swelling, then pain in both arms from elbows to hands, and then it started in the back on her thighs in hips bilaterally and her right ankle. She still has the headache that is unchanged x 1 month, but the other symptoms were new, and she had never had them before. She still has it and it is 1/6/21.
53 2021-01-05 pain in extremity Muscle pain; Got little ache in the back; Joint pain; Fever; Chills/felt like chills like when you f... Read more
Muscle pain; Got little ache in the back; Joint pain; Fever; Chills/felt like chills like when you feel cold; arm be sore from the shot; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home. Medical history included Blood pressure high. Concomitant medications included metoprolol for Blood pressure high, potassium. The patient had got her COVID-19 Vaccine yesterday (29Dec2020) and now (30Dec2020) she had a little muscle pain, guess from the arm. She got the shot in her muscle yesterday. Today (30Dec2020), spiked a little fever, and she got a little muscle pain, joint pain. She felt good, she just got little ache in the back. She took some Tylenol, it has all worked today. The patient also experienced "arm be sore from the shot". She got a little chill that's why she took the Tylenol. she had a little fever, she caught fever or felt like chills like when feel cold. Therapeutic measures were taken as a result of ache in the back, fever, and chills included Tylenol. The outcome of the events was unknown.
53 2021-01-06 weakness, hot flush Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injectio... Read more
Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure. Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day. Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped. Will try Benadryl.
53 2021-01-06 weakness Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and se... Read more
Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and self-care instructions: drink plenty of fluids, take motrin if needed.please return if symptoms worsen or persist.
53 2021-01-06 facial paralysis, tingling, numbness Bells Palsy?left facial droop and left facial numb/tingling
53 2021-01-07 cold sweat After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Pat... Read more
After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Patient denied dyspnea, nausea, DM/hypoglycemia issues, known heart issues, swelling/itchiness, adverse event with first vaccine, and no adverse event to previous other vaccines. Patient had eaten lunch, but just come off of a shift and thought she might be dehydrated. Water was provided to the patient. Patient stated that she had intermittent lightheadedness/dizziness. Patient denied performance of vasovagal maneuver. Patient also experienced tachycardia and was clammy. Cool pack was provided to patient. Clinical course below: 1530 145/81, 105, 97%, 15 1535 119/81, 88, 96% 1540 126/75, 87, 96% 1542 pt felt another wave of lightheadedness, HR 103 1546 126/79, 90, 96% 1551 128/80, 91, 96% 1555 140/60, 79, 96% 1559 110/84, 87, 97% 1600 pt reports new scratchy throat 1602 25 mg Benadryl administered by RN 1603 discussed with Pharm D 1605 131/77 91, 97% 1611 145/79, 95, 98% Pt finished 12 oz of water and 4 oz of juice 1615 pt reports throat feeling better 1615 118/62, 69, 96% 1630 109/95, 99, 97% Pt stuck out tongue, no evidence of edema 1621 127/72, 84, 97%  At 1642, patient was discharged to family's care and taken home.
53 2021-01-07 feeling cold, tremor felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; ... Read more
felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; body aches; snoring bad; freezing/ can't get warm; shaking; felt terrible; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the right arm on 28Dec2020 13:15 at a single dose for COVID-19 immunization. She has had the Coronavirus before and wanted to know if previously having the virus might make her side effects worse. She had COVID 19. She got her positive result on 06Aug2020. Her husband had it too. She knows what it is like. She didn't have to go to the hospital, but she had a severe enough case. She had the fever, dry cough, body aches, nausea, and poops. She has been getting body aches after having COVID really intense. She gets tired very easily. She had fibromyalgia was diagnosed more than 10 years ago and ongoing, before the year 2000; acid reflux was diagnosed five or six years ago; high blood pressure was diagnosed back in 2007; high cholesterol; wheezing for a couple of years and depression. The patient was also taking a water pill. Concomitant medication included omeprazole ongoing for acid reflux, hydrochlorothiazide (HYDROCHLOROTH, 25 mg) ongoing, losartan 100 mg ongoing, desvenlafaxine 75 mg ongoing for depression, montelukast 10 mg ongoing for wheezing, atorvastatin calcium ongoing for cholesterol. When asked for the lot number the patient said that she thinks it is EL1284 but it could possibly be ELI284. On 28Dec2020, the patient felt really tired, has a sore arm with chills, fever and body aches. The same day she got the vaccine she had felt fine. She came home and did a few things. She sat down for a minute and then it was like wham. She told her husband she was done. She went to sleep fast and slept for a couple of hours. She went to work the next morning and her arm was sore to touch and to lift it up. Sometimes when you get the flu shot it is like that too. She does not have any red marks where it was injected. She only knows where it was because it hurt to touch. She got really tired at work about 11:30AM. Her body started aching. She was being tested twice a week for Corona COVID. She had just been tested on 28Dec2020 morning before the vaccination and was negative. On an unspecified in Dec2020, she was freezing and shaking. She cannot get warm. It was like that for a couple of hours. Usually her temperature runs low. It was up to 100.1 degrees Fahrenheit which is high for her because she usually is on the lower end. She felt really ugh.The symptoms after the vaccine reminded her of when she had COVID. She had a low fever and body aches and felt terrible. Her boss wanted to know if she had the flu. The patient does not think so because it would be ironic the day after she gets the shot. She was assuming it was the side effects from this. She further clarified wham as that she was really tired and it came over her really quick. She sat in the chair and got a blanket. Her husband said she was snoring bad (28Dec2020). Two hours later the dogs woke her up and she thought it was the middle of the night. It wasn't it was early. On unspecified date in Dec2020, she had a bout and her body started aching. A day after, she does not feel that bad, does not have fever and her body was not aching. That night when she got home she could not sleep on her arm because it was sore. The next day was when it was hard to lift it. She had the injection in the right arm, which is the arm she uses. It was still sore to touch. She has fibromyalgia. She is not sure if that is why she is aching. She is not sure if that kicked it in high gear. The vaccine was administered in a Long Term Care Center. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The events did not result to emergency room nor physician visit. The outcome of the event fever and body aches recovered on an unspecified date in Dec2020; outcome for all other events was unknown. Information on the lot number has been requested.
53 2021-01-07 feeling hot My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; I... Read more
My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; This is a spontaneous from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included hypertension. Concomitant medication included lisinopril for hypertension. On an unknown date, her arm was rather red and huge almost looks like a, not a Hematoma but its about that big. She didn't feel bad otherwise. It was just red and swollen and warm. The outcome of the event was unknown.
53 2021-01-07 muscle spasms, pain in extremity Myalgia bilateral leg and right ankle pain, reports calf tightness and cramping to lower extremities... Read more
Myalgia bilateral leg and right ankle pain, reports calf tightness and cramping to lower extremities Narrative: developed bilateral leg pain, tightness of calf muscles within one hour of receiving vaccine. Headache on 12/23/2020
53 2021-01-07 pain in extremity chills, nausea, arm sore
53 2021-01-07 tingling Felt severe itching pins needles on arms, wrists, chest & neck.
53 2021-01-07 tremor neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and s... Read more
neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
53 2021-01-08 weakness 12 hours post injection- fever of 101.8, body aches, headache, fatigue. Lasted about 23 hours before... Read more
12 hours post injection- fever of 101.8, body aches, headache, fatigue. Lasted about 23 hours before fever was back to normal. Still have fatigue and weakness
53 2021-01-08 flushing 1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes... Read more
1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes left inguinal, fever of 102.3F, diaphoresis, chills, flushed face, change of taste and baseball sized swelling to injection site.
53 2021-01-09 feeling cold Fever Chills Aches Fatigue
53 2021-01-09 pain in extremity Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midn... Read more
Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midnight after received and still hurting, joint pain and headache began early AM 01/09/21. All have ended except pain at injection site and joints still achy.
53 2021-01-10 weakness, tremor Chills and shakes without fever, weakness, and headache
53 2021-01-10 weakness 1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever... Read more
1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever 107., joint pain --over the counter ibuprofen no relief, weakness in legs. 1/9/2021 body aches and fever resolved. Fatigue, weakness and joint pain, Tylenol --some relief. Swollen lymph nodes in left armpit and soreness; low back pain, shooting hip pain.
53 2021-01-10 numbness Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red... Read more
Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red large hives all over my body including my face/head; numbness to my hands/feet/chest area; the SOB started; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU9231), via an unspecified route of administration in the left arm on 30Dec2020 at 08:30 as a single dose for COVID-19 immunization. Medical history included hypothyroidism and chronic low back pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), and etodolac (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took miconazole nitrate (MONISTAT) on unknown dates for an unknown indication and experienced drug allergy. On 31Dec2020 at 10:00, the patient started with a red raised rash under her arms and waistline and as the day progressed the rash turned hot to touch with raised red large hives all over her body including her face/head. By 23:00 on 31Dec2020, the patient had already taken 3 doses of diphenhydramine (BENADRYL) which was not effective. Then, later on 31Dec2020, shortness of breath started with numbness in the hands/feet/chest area. Her daughter took her to the emergency room. She was started on intravenous diphenhydramine, dexamethasone, and famotidine (PEPCID). The medications took time to work but they did resolve her shortness of breath and the hives subsided to mild redness. She was sent home and given the following medications to take: diphenhydramine 50 mg every 4 hours, methylprednisolone (MEDROL DOSE PAK), cetirizine (ZYRTEC) daily, and famotidine (PEPCID) daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the red rash, rash was hot to touch, shortness of breath, and numbness, were reported as recovered with lasting effects; while that of the hives was recovering as they still flared up if she did not take the medications every 4 hours. The reporter assessed all the events as non-serious.; Sender's Comments: The reported shortness of breath together with red rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE together with rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), due to temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
53 2021-01-10 pain in extremity, tenderness soreness in arm, not just to the touch, but hard to lift arm the next day. Better after day 2.
53 2021-01-10 pain in extremity 90 minutes after the second vaccination in the COVID series, pfizer version, she developed right arm... Read more
90 minutes after the second vaccination in the COVID series, pfizer version, she developed right arm weakness. she could not lift her arm above her head. she then developed severe dull, aching pain. the pain became sharp with movement. she could not sleep because of the pain. no redness or edema at the injection site. she is slowly regaining strength and range of motion in the arm, however the pain still remains and full strength has not returned.
53 2021-01-10 pain in extremity Left arm pain; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old fem... Read more
Left arm pain; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0142, intramuscularly in the left arm on 04Jan2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included an allergy to sulfa, from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 04Jan2021 at 09:45 the patient experienced left arm pain. The patient was not treated for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm pain was unknown.
53 2021-01-10 tingling A 1/2 hour after receiving vaccine my fast started to tingle and it lasted almost 24 hours. I have ... Read more
A 1/2 hour after receiving vaccine my fast started to tingle and it lasted almost 24 hours. I have had Bell's Palsy in the past (30 years ago)
53 2021-01-10 tremor Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tyleno... Read more
Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tylenol/ zofran but felt like I was going to vomit. Went into the bathroom and sat down. Woke up on the floor shaking. Not sure how long I was down. According to my watch my HR was around 110+ for a hour and a half (3-4:30 am)
53 2021-01-11 burning sensation, tingling Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sens... Read more
Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sensitive from left flank down toward mid buttocks slightly toward anterior area; This is a spontaneous report from the Medical Information Team. A contactable nurse reported that a 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via intramuscular route of administration in the left arm, from 24Dec2020 08:15 at a single dose for COVID-19 immunization. Patient had no other medical history (reported as "none"). Concomitant medication included melatonin, calcium and bupropion hydrochloride (WELLBUTRIN). The patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 27Dec2020 09:00, the patient experienced shingle type pain burning, tingling and very sensitive from left flank down toward mid buttocks slightly toward anterior area. The outcome of events was reported as "not recovered". Therapeutic measures were taken as a result of events included motrin, tylenol and lidocaine. Patient was unable to go to work for a few days. No follow-up attempts are possible. No further information is expected. Information on the batch number has been obtained.
53 2021-01-11 feeling hot, pain in extremity Second dose: A few minutes after getting vaccine. I was sitting in the observation area and I start... Read more
Second dose: A few minutes after getting vaccine. I was sitting in the observation area and I started feeling a pinch in my arm, then I started feeling warm and light headedness. Then they checked my bp and it was 149/93 . Then I had to stay for 30 mins, then I left to go home. I had body ache and a mild temperature. It was 98.2 .My arm is sore, and my joints and body hurts. I have a headache too , and I just took an ibprophen. I am still not feeling well. I did not go to the ER, hospital or doctors office about this ae.
53 2021-01-11 flushing, tingling Metallic taste in mouth; cotton/dry mouth while trying to swallow; flush/tingling sensation throug... Read more
Metallic taste in mouth; cotton/dry mouth while trying to swallow; flush/tingling sensation throughout body but especially extremities. Occurred within the 5-15 min observation period. I did not speak up about it as I was trying to analyze it myself and rationalize the symptoms. It did not cause tachycardia or SOB or intervention but it makes me a little hesitant for the 2nd dose due to my shellfish allergy/sensitivity. The sensation reminded me of the systemic response when receiving a contrast IV dye. I did leave a message at the VAERS 800# to ask if I should submit this form but did not want to delay any longer in case this information is helpful with the feedback/data for others. I understand it is not a true "adverse or sentinel" event but I wanted to report my reaction especially with the shellfish allergy (which I wasn't aware of to be a risk factor until I read more articles about it).
53 2021-01-11 flushing 4/5 hours bad headache, flu symptoms , nausea, Later that night I had chills, fever and was flush... Read more
4/5 hours bad headache, flu symptoms , nausea, Later that night I had chills, fever and was flushed which all lasted two days
53 2021-01-11 migraine Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photo... Read more
Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photophobic), nausea & diarrhea. This occured 4 days after my second COVID-19 vaccine. I had no symptoms prior to this.
53 2021-01-11 pain in extremity Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 wa... Read more
Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 was extremely tired. When getting out of bed in AM blacked out and fell to the floor. Was able to get up but head was cloudy all day long. She felt very sore and head hurt all day. The next am had headache.
53 2021-01-11 pain in extremity Fatigue, sleepiness, pain on left arm
53 2021-01-11 pain in extremity A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 ... Read more
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 hour later. After 2 hours of the shot, the left arm began to be noticeably sore. 12 hrs post vaccine, I had flu-like symptoms. 24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced considerable lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area. 36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area. Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm). Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
53 2021-01-12 burning sensation, muscle spasms, tremor Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the j... Read more
Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the jaw line to under the chin, malaise, large muscle spasms and cramps, chills and shaking, soreness and swelling at injections site, burning in face and lips, and severe unexplained drop in blood sugar (56) that was very slow to bring back up.
53 2021-01-12 muscle spasms 12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND ... Read more
12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND DIZZY, THROBBING HEADACHE. CRAMPING/ACHING IN BACK OF CALVES. 12/24/2020 CONTINUED WITH DIZZINESS, THROBBING HEADACHE, BLOOD PRESSURE ELEVATED, CHEST PRESSURE 8:00 PM REPORTED FEELING THAT SHE WAS GOING TO DIE, WENT TO LAKE CITY MEDICAL CENTER- BLOOD PRESSURE ON ARRIVAL 184/101 HR. 117. GIVEN NITRO AND MEDICATIONS. ADMITTED, DISCHARGED 48 HOURS LATER ON 12/26/2020. DISCHARGED ON BLOOD PRESSURE MEDICATION 12/27/2020-LESS THAN 24 HOURS AFTER BEING DISCHARGED SHE WAS READMITTED TO MEDICAL CENTER WITH SAME SYMPTOMS. 36 HOURS AFTER ADMISSION, TRANSFERRED TO MEDICAL CENTER. FOR CARDIC WORKUP AND HIGHER LEVEL OF CARE.
53 2021-01-12 pain in extremity anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a co... Read more
anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received bnt162b2 (Pfizer-biontech covid-19 vaccine), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. Medical history included shellfish allergy. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date, dizzy on 31Dec2020, arm was really sore on an unspecified date, tiredness on an unspecified date. Event details: She was dizzy that day especially with changing positions, she didn't need to go to the doctor or anything. It wasn't severe. She was just a little dizzy. It's probably just the vaccine and it did go away. Her arm was really sore and went away after a few days. the tiredness, it wasn't a big deal. She did feel better about. it wasn't a serious anaphylactic reaction. It didn't happen right away. She had arm soreness. it wasn't immediate. She usually didn't have. It was really weird. She thought she was well hydrated. The outcome of event was really sore was resolved, outcome of other events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events due to temporal relationship. There is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
53 2021-01-13 burning sensation 1/4/21 within 4 hours of patient receiving 1st dose COVID-19 vaccination, itching began on sole of r... Read more
1/4/21 within 4 hours of patient receiving 1st dose COVID-19 vaccination, itching began on sole of right foot in arch area. Morning of 1/5/21 itching began on sole of left foot in arch area. Patient look at both feet and noticed a red rash on soles of both feet in arch area approximately 1.5" - 2" in diameter. 1/6/21 blisters developed on right foot in rash area. 1/8/21 patient went to dermatologist; the dermatologist ruled out bacterial and fungal infections. Dermatologist prescribed a topical steroid lotion and an oral antihistamine (Hydroxyzine HCL 25mg). 1/9/21 patient reported severe burning and itching of both feet and self-treated with a frozen foot roller which successfully subsided the burning and itching. 1/10/21 discontinued use of steroid lotion. Continues to take oral antihistamine. 1/11/21 blisters are gone but rash is deep red and still exists as of today without itching or burning.
53 2021-01-13 burning sensation 1/4/21 within 4 hours after receiving vaccine sole of right foot in the arch area began to itch. Mo... Read more
1/4/21 within 4 hours after receiving vaccine sole of right foot in the arch area began to itch. Morning of 1/5/21 sole of left foot in arch area began to itch. Upon a visual check a red rash is present approximately 1.5"-2" in diameter on the soles of both feet in the arch area. 1/6/21 blisters formed in rash area of the right foot. On 1/8/21 upon patient visiting her dermatologist, the rash was ruled out as not being caused by a bacterial infection or fungal infection. Dermatologist prescribed an antihistamine oral medication and a steroid cream. 1/9/21 patients reports burning and itching increased and she used a frozen foot roller to treat the burning and itching. 1/10/21 Patient states that itching and burning subsided and discontinued use of steroid cream. Patient continues to take oral antihistamine (Hydroxyzine HCL 25mg) prescribed by dermatologist . Patient reports there have been no changes in soaps or detergents being used and no changes in behavior prior to vaccination and therefore, patient and doctor can, but without certainty, conclude that the rash is a result of the COVID-19 vaccination. 1/11/21 patient took pictures of rash and are available for viewing. As of 1/14/21 rash still present but itching has stopped. This event is a non-severe adverse event. Patient is scheduled to receive second dose of vaccination on 1/25/21. Patient has been advised to take antihistamine prior to receiving second dose of vaccination and again 12 hours following the 2nd dose of vaccination.
53 2021-01-13 cold sweat, tremor, weakness Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm ch... Read more
Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm chills, temp 97.8 7:00pm warm shower 7:15pm diarrhea, shortness of breath, sweat dripping down body, dizzy, nauseated 7:45pm cool compresses on head and neck, clams, shortness of breath, still dizzy, weakened began shacking. 7:55pm. Dressed by husband and put in bed. Temperature 90.0 8:00pm 3 blankets on me, gloves on, socks and slippers on and heating pads to ankles and feet, still dizzy and shacking. no circulation to hand or feet. no capillary refill. 8:30pm Called nurse on Call who stayed on the phone with me for 45 minutes, two Advil taken. Trying to eat crackers and hydrate. 8:45pm. feeling blood flowing to hands but not feet. 9:45pm gloves off hands and heavy blanket off, toes still ice cold.10:15pm Up to bathroom with husbands help, no strength. Urinated, no more diarrhea. Stomach still making a lot of noise. Still sensitive to light and sound, feeling to toes, still dizzy.11:30pm Feeling more like myself. Just exhausted. Slept off and on throughout the night and hydrated and up to urinate on my own without assistance. Jan. 14, 2021 , 10:00am- Sitting up in bed. Very tired. Drinking water. 12:00 noon able to eat an egg and avocado sandwich
53 2021-01-13 feeling hot, breast pain FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, ... Read more
FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, CHILLS, SEVERE HEADACHE, ITCHY IN THE VACCINATION AREA AND PAIN IN THE VACCINE ARM AND RADIATES UNDER THE ARMPIT TO THE BREAST AND DIARRHEA
53 2021-01-13 feeling hot Patient experienced rash shortly after administration. Felt hot. Patient took zyrtec. Was having a... Read more
Patient experienced rash shortly after administration. Felt hot. Patient took zyrtec. Was having a little bit of difficulty breathing. Symptoms except rash resolved after 30 minutes of observation. Patient discharged home from the vaccination clinic.
53 2021-01-13 hot flush Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on ... Read more
Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1284) intramuscularly at right arm on 06Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies to opiate derivatives and penicillin. Concomitant medication included clopidogrel, sertraline, simvastatin. The patient previously received first dose of bnt162b2 (lot number: ELC5730) intramuscularly at right arm on 18Dec2020 13:00 at single dose for COVID-19 immunization. The patient experienced fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue, all on 07Jan2021 01:30. No treatment received. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
53 2021-01-13 migraine 15 hours after the vaccine was received I started to experience a migraine-like headache, nausea and... Read more
15 hours after the vaccine was received I started to experience a migraine-like headache, nausea and muscle aches.
53 2021-01-13 migraine stomach issues, migraines. body aches Fatigue
53 2021-01-13 pain in extremity Left arm soreness for 24 hours and low grade fever of 100 F; Left arm soreness for 24 hours and low ... Read more
Left arm soreness for 24 hours and low grade fever of 100 F; Left arm soreness for 24 hours and low grade fever of 100 F; This is a spontaneous report from a contactable nurse. A 53-year-old non-pregnant female received bnt162b2 (lot: EK9231), intramuscular in the left arm on 30Dec2020 14:30 at a single dose for covid-19 immunization. The patient's medical history included migraine, seizure (resolved x2years) from an unknown date and unknown if ongoing , and allergy to penicillin. There were no concomitant medications. On 30Dec2020 20:00, the patient experienced left arm soreness for 24 hours and low grade fever of 100 f. The outcome of the event was recovered on an unknown date. No treatment was given to the patient for the event. The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have Covid prior to vaccination and has not been tested post vaccination.
53 2021-01-13 tingling Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lig... Read more
Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lightheaded 1st, then headache, feels like someone is pressing down on head and neck- temples and note- feels like a band around head. Pain is 2/10, progessed to 6/10. States muscles are starting to get sore around trapezius region. Stated she had feeling of euphoria initially, BP 128/76, HR 66, 98% RA. Nausea, but no emesis. Metallic taste to mouth- pins and needles when drinking water.
53 2021-01-14 flushing, tingling fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in... Read more
fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; This is a spontaneous report from a contactable Nurse, the patient. This 53-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (dose #1), via an unspecified route of administration in the right arm on 07Jan2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. Medical history included food allergy (shellfish) from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa) from an unknown date and unknown if ongoing, migraine headaches from an unknown date and unknown if ongoing and contrast media allergy (lodine dye) from an unknown date and unknown if ongoing. Concomitant medication included propranolol (PROPRANOLOL), vitamin d3 (VITAMIN D3) and ascorbic acid, zinc (VITAMIN C + ZINC). The patient previously took avelox and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 07Jan2021 at 14:30, the patient experienced metallic taste in mouth, cotton mouth and flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after. She did not tell anyone, just tried to work through it. The patient thought it was strange. She has a shellfish allergy/sensitivity, not sure if it was related. On 08Jan2021 (reported as the following day after vaccination), the patient experienced low grade fever, chills, malaise and body aches. Therapeutic measures taken included Advil and Tylenol. The clinical outcome of metallic taste in mouth, cotton mouth, flush/tingly sensation in extremities, low grade fever, chills, malaise and body aches was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
53 2021-01-14 numbness Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- ... Read more
Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- Right Axillary lymph nodes swelling, grapefruit size, painful. Edema from injection site to fingertips with numbness to 3,4,5 digits. Fatigue and headache. Day 4- RIGHT sided lymph nodes swelling, palpable to neck, axillary and groin. Severe fatigue. Headache. Edema still complete to RUE- with numbness to fingers. Grapefruit sized axillary, slightly improved. NO FEVER, COUGH, DYSPNEA
53 2021-01-14 pain in extremity, tingling shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontan... Read more
shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 10:30 in left arm at single dose for COVID-19 immunization. Medical history included mild hypertension, chronic migraine and recent elevated liver tests - Alk Phos (alkaline phosphatase) & GGT (Gamma-glutamyltransferase) from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate 25 mgs daily and colecalciferol (VITAMIN D). On 07Jan2021 21:30, following shot for a few minutes, the patient experienced left arm tingled, had a brief period lasting a few minutes of shivering that evening and tachycardia. Noted at 9:30 pm, patient's BP 139/89, pulse 88 (BP 115/88 and pulse 76 4 days prior). Then BP 148/91, pulse 69 at 10 am on 08Jan2021 after two doses of Metoprolol Succinate ER 25 mgs at 9:45 pm on 07Jan2021 and at 8:30 am on 08Jan2021. The patient experienced left arm very sore on 07Jan2021 after receiving vaccine. Seems to be improving on 08Jan2021. The outcome of the events was not recovered. no treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
53 2021-01-15 weakness Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very... Read more
Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very big, injection site is harder. Lower back at kidney sites are so painful. Weakness. No energy to lift up arms or legs. Have difficult to get up and get out of bed to get medicine or food. So sleepy, maybe because Tylenol 500mg q4h to help for pain but reduce just little from 10 down to 8 for a short time enough to get out of bed to get something. Ice pack at armpit, heat pat at lower back but just reduce the pain from 10 down to 9 only. No appetite. Eat lentil and rice porridge but indigestible and have to take Pepcid. All symptoms prolong until Friday 1/15/2021 around 1pm. I pushed myself hard to get up to drive to employee health for testing which I missed on Thursday due to unable to get up. After that the symptoms down to moderate that I able to report CDC. I wonder why 2 dose is so horrible to me.
53 2021-01-15 tingling Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 min... Read more
Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 minutes after receiving the 2nd COVID vaccine dose. Patient reported symptoms felt similar to times when she had exposure to cats or after exercising. She denies any previous treatments for anaphylaxis or any previous severe reactions. Vital signs at time of initial assessment were BP 147/100, pulse 80, O2 Sat 99% on room air. Patient was observed for 50 minutes and chest tightness/arm tingling symptoms resolved. Patient did also develop a dry "tickly" cough about 60 minutes post vaccination. Patient was administered albuterol 2 puffs via MDI and reported improvement of cough. She again reported the cough to be similar to the type of cough she had gotten when exposed to cats. No further treatment needed. Patient stable and released to go home.
53 2021-01-16 burning sensation Hives on both arms redness itching burning
53 2021-01-16 feeling cold Fever, chills, achey, underarm pain.
53 2021-01-16 muscle twitching, pain in extremity, feeling hot Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the... Read more
Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the right arm and neck and right ear. The left arm felt like battery acid, hurt super bad. Felt like an outer body experience. Was given Benadryl. Was having a problem clearing her throat. Felt weird by her bellybutton, felt like she had on a corset on. Rash developed at sternum and bellybutton. Went over to her ER at work. The knee to the hip felt like she had cement on them. Her tongue started to swell. She was wheeled up to tramum2. She blackout at some point. Her body was doing one thing and her mind another. She had EpiPen stat. Right was twitching like Parkinson's. After 1 1/2 she started feeling a little better. 69/43 bp recorded. The next few days she felt like she had Mono.
53 2021-01-16 pain in extremity, tingling I received the Covid vaccine. The injection itself was without any issues. However, 6-7 hours later,... Read more
I received the Covid vaccine. The injection itself was without any issues. However, 6-7 hours later, my entire upper arm began aching-pain from my trapezius down to my elbow. This continued throughout the weekend and then Monday, my index and middle finger began tingling (as if asleep). This symptom has never subsided. I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist. I have tired trigger injections in my trapezius, ibuprofen, muscle relaxers, heat, exercises, a steroid burst-all without relief of symptoms. I am able to move my arm and I do have strength in the extremity. I have seen a specialist in physical medicine and rehabilitation. What I believe may have triggered this reaction is that in October I had a radial and ulnar tunnel release in the same extremity. I wonder whether the medication has affected the nerves that had been manipulated during surgery. I am wondering if anyone participating gin the trial had recent surgery was well? if so, did they note any complication after receiving the vaccine. Any help you can give would be appreciated. Thanks you for your time.
53 2021-01-16 pain in extremity Not adverse. Arm pain the following day lasted approximately 2 days, no visible issues at injection ... Read more
Not adverse. Arm pain the following day lasted approximately 2 days, no visible issues at injection site.
53 2021-01-16 tingling, numbness I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower... Read more
I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower leg. Tingling spread to both feet & hands arms lower legs. Slight swelling of tongue/ throat but I could swallow and breathe. It is now 16 hours since I received the vaccine and I?m still experiencing tingling / numbness and slight tongue/ throat swelling. I have decided to take Benadryl to see if it helps.
53 2021-01-17 facial pain, pain in extremity, numbness soreness in entire arm similar to being stung by a wasp; numbness and soreness in left side of face ... Read more
soreness in entire arm similar to being stung by a wasp; numbness and soreness in left side of face similar to the feeling after dental work when the shot has worn off. It has been 3 hours that I've felt this. It is still that way.
53 2021-01-17 tingling, burning sensation neck lymph node swelling; then 30 hours after receiving vaccine hands turned red and burned, pain an... Read more
neck lymph node swelling; then 30 hours after receiving vaccine hands turned red and burned, pain and swelling in arm pits. currently have increased paresthesia arms, hands, legs and feet
53 2021-01-17 seizure pt started having seizures and was given ativan. EMTs were called and patient was taken to the ER
53 2021-01-18 weakness Fever up to 101.0, body aches, chills, fatigue, weakness, redness at injection site, tender at injec... Read more
Fever up to 101.0, body aches, chills, fatigue, weakness, redness at injection site, tender at injection site, swollen lymph nodes in neck, axilla, L breast, headache that started at 6 am the following day. I took Tylenol which did help fever and body aches. I had symptoms until 1/11/21 and started feeling better at 11 am.
53 2021-01-18 bell's palsy Went to Urgent Care 01/17/2021. High blood pressure and sent to ER. R/O stoke. Gave 3 steroids an... Read more
Went to Urgent Care 01/17/2021. High blood pressure and sent to ER. R/O stoke. Gave 3 steroids and antiviral for 10 days. Was diagnosed with Bells Palsy. Has facial and facial drooping. Left eye will not blink and has to use omit to keep eye moist.
53 2021-01-18 bell's palsy On 1/17/2021 I woke up with my face drooping. I went to the ER and was diagnosed with Bells Palsy.
53 2021-01-18 feeling cold 13 hours after receiving vaccine I woke up with uncontrollable chills lasting over 2 hours accompani... Read more
13 hours after receiving vaccine I woke up with uncontrollable chills lasting over 2 hours accompanied by severe body aches lasting over 24 hours, fever exceeding 103, headache and complete fatigue where I physically could not get out of bed. Tried to control fever and aches using both Tylenol and Ibuprofen simultaneously and lowest fever would go was 100.5. Fever broke after 26 hours . Two days later had labored breathing, headache and fatigue. All side effects went away except for severe headache which I have currently had now for 6 days .
53 2021-01-18 feeling hot Pt felt warm and dizzy. Shared had not eaten all day prior to vaccine. Hx of hypertension and bp was... Read more
Pt felt warm and dizzy. Shared had not eaten all day prior to vaccine. Hx of hypertension and bp was elevated. Observed in clinic and given food / gatorade. Pt recovered without incident and released.
53 2021-01-18 feeling jittery c/o being anxious, jittery
53 2021-01-18 flushing, pain in extremity, tingling Patient experienced arm pain, paresthesia, facial flushing, lightheadedness and sensation of dysph... Read more
Patient experienced arm pain, paresthesia, facial flushing, lightheadedness and sensation of dysphagia for several minutes after vaccine was received. Benadryl PO given when symptoms began. Patient was evaluated in the EC and was discharged home without symptoms.
53 2021-01-18 pain in extremity, numbness, tingling Tingling and numbness in
53 2021-01-18 pain in extremity headache; fever 102.7; Chills; vomiting; arm pain; body aches; This is a spontaneous report from a c... Read more
headache; fever 102.7; Chills; vomiting; arm pain; body aches; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular on 18Dec2020 15:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma and diagnosed with COVID-19 prior to vaccination. Patient has unspecified allergies. Unspecified concomitant medication were taken (List of any other medications the patient received within 2 weeks of vaccination: Yes). The patient experienced fever 102.7, Chills, vomiting, arm pain body aches and headache on 19Dec2020 03:00. No treatment received for the events. The outcome of the events was recovered with sequelae (Recovered with lasting effects). The events were considered as non-serious. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular on 08Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date.
53 2021-01-18 pain in extremity Right eye blood shot at 7:30 pm - went to ER with severe stomach cramps radiating the back. CT done... Read more
Right eye blood shot at 7:30 pm - went to ER with severe stomach cramps radiating the back. CT done. received dilaudid and Zofran for pain and nausea. Next day, had pain in bones, feet, knees, back and neck. Also sore throat, red throat, headache, nausea, and diarrhea. Doctor prescribe antibiotics and Norco. Stomach pain returned 12/31.
53 2021-01-18 speech disorder, weakness right side of tongue from midline, swollen approx. 3X size of left side. some difficulty swallowing,... Read more
right side of tongue from midline, swollen approx. 3X size of left side. some difficulty swallowing, water. approx. 45-50 minutes after I woke with this, I noted a large sore area on the lateral left side of my tongue. Arrived at work 6:30am and noted I was speaking with a "lisp" and tongue was still the same, no changes noted. Very tired, no energy. Reported this to our employee health at 8:00 am when they opened. I then was offered a Claritin by a coworker. approximately 2 hours later the swelling and sore had completely subsided.
53 2021-01-19 weakness ? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swellin... Read more
? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swelling of your face and throat ? A fast heartbeat ? A bad rash all over your body ? Dizziness and weakness
53 2021-01-19 facial paralysis ON 1/20/21 DEVELOPED EYE/MOUTH DROOPING, VOMITING, NAUEA, CHILLS AND BODY ACHES. HAS CALL OUT TO PCP
53 2021-01-19 muscle spasms, weakness chills; Headache; muscle spasms; extreme weakness; body aches; fever; sinus congestion; This is a sp... Read more
chills; Headache; muscle spasms; extreme weakness; body aches; fever; sinus congestion; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 09:45 at single dose for covid-19 immunisation. Medical history included hypertension (HTN), high cholesterol. Concomitant medication included lisinopril, levocetirizine dihydrochloride (EURO ZYSOL), ezetimibe (ZETIA) and stool softner. No other vaccines within 4 weeks prior to the COVID vaccine. No diagnosed with COVID-19 prior to vaccination. The patient experienced woke up with chills, headache, muscle spasms, extreme weakness, for 24 hours continued with body aches, fever, sinus congestion. Still have sinus congestion, all other symptoms ended in 24 hours from onset. Events onset date reported as 09Jan2021 01:00. No treatment received for the events. Outcome of events was recovered with sequelae. Since the vaccination the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
53 2021-01-19 tremor Shakes, fever of 102.8, sever body aches, diarrhea, headache, dizziness Lasted 24 hours.
53 2021-01-20 migraine Migraine; Mild pain at injection site; This is a spontaneous report from a contactable other healthc... Read more
Migraine; Mild pain at injection site; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 53-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 4178) Intramuscular on 08Jan2021 09:15 AM at left arm at single dose for COVID -19 immunization in Hospital. Medical history was none. No Known allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. Patient receive the first dose of bnt162b2 (lot number: EK5730), intramuscularly on the left arm on 18Dec2020 at 13:15 at single dose for COVID-19 immunization and experienced injection site soreness (Day 1 and Day 2) and mild headache (Day 2). Patient experienced mild pain at injection site (Day 1 and Day2, 08Jan2021 12:00 PM) and Migraine (Day 2, 08Jan2021 12:00). COVID was not tested post vaccination. No treatment received. Patient was recovered from the events in Jan2021.
53 2021-01-21 feeling cold Reported extreme fatigue, chills, body aches, head ache, and fever 100.6
53 2021-01-21 pain in extremity, weakness First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chill... Read more
First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chills, and her arm was very sore for a day. Second dose was given 1/15- On 1/19 she had body aches, chills, severe headache, fatigue, abdominal pain, stuffy nose and sore throat. Her arm was very sore for several days, she could not raise her arm. Treatment: took tylenol every 6 hours for 24 hours. on 1/19 and 1/20 she took Dayquil.
53 2021-01-21 pain in extremity Approximately 11 hours after receiving vaccine developed chills,fever,headache,bodyaches,arm pain
53 2021-01-21 throat numbness Pt c/o tongue tingling and 'molars' numbness as with first injection in which she reported to after ... Read more
Pt c/o tongue tingling and 'molars' numbness as with first injection in which she reported to after sx started. This injection, sx started earlier. No soa, itching, throat tightness or distress. Pt numbness and tingling resolved and then returned with some throat numbness. Pt remained without distress and after observation period opted to be dismissed and no er visit, called for ride, stated sx almost resolved at time of dismissal, no distress. Dismissal vs- 117/83 bp 79 hr 98% sao2
53 2021-01-21 tenderness On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening e... Read more
On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening especially in back of neck, worsening headache. 1/7 awoke with nausea/vomiting lasting throughout the day and diarrhea also started. 1/8 continued vomiting but diarrhea stopped and also noted confusion and brain fog. 1/11 mostly recovered and back to work with slight headache and body soreness from exhaustion.
53 2021-01-21 tremor Started with shaking chills at 11:45 pm 1/10/21 and fever spikes up to 103 degrees with body aches, ... Read more
Started with shaking chills at 11:45 pm 1/10/21 and fever spikes up to 103 degrees with body aches, nausea, vomiting and diarrhea, continuous headache for 4 days. Then started with productive cough and dyspnea on exertion. Took Tylenol initially and then Proair inhaler starting 1/15
53 2021-01-23 feeling hot, feeling cold, pain in extremity No temperature prior to Vaccine. Track daily - run 97.4-97.7F normally Friday 1/22/2021: 1930 starte... Read more
No temperature prior to Vaccine. Track daily - run 97.4-97.7F normally Friday 1/22/2021: 1930 started feeling very tired 2030-2230: started to feel cold, skin sensitivity, developed into shaking chills, entire body shaking. Headache. Temperature rising 99F -- 100.4F --- 101.5F about every 1/2hr or so. 2100 Took Advil 600mg Midnight: Chills, HOT, Temp 102.4F. Dozing off and on through the night. Shaking and Hot. Headache. Feeling Nausea 0400: Temp 101.6F, tried to take Ibuprofen but dry heaved them back up. Sips of water. Took warm shower. 0500: back to bed, slept 1 hour 0600: saltines, gingerale - took Advil 600mg - laid back down. Head throbbing. Less Nausea. 0830: woke: Temp 100.4F Headache and hot, feel achy all over never leaves, feel woozy. Spent most of Saturday 1/23/2021 (My 54 Birthday) Laying and sleeping. Started taking Tylenol 1000mg (1/23 at 6pm) alternating with Ibuprofen 600mg every 6 hours exactly. Woke Sunday Morning - feeling less achy, but still with Temp 100.4-99.6F -- As Sunday went on - by afternoon/evening achy, skin sensitive, and Temp 100.4F, HEADACHING! Neck aching. Took Ibuprofen 600mg. Drinking gingerale and water through the day. Toast. Now almost Midnight 1/24/2021 Headache and feeling achy. (Right ARM only slight hurt this time. 1st Pfizer - hurt 8/10 day 2 &3)
53 2021-01-23 flushing, tingling Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started... Read more
Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started a prickly tingle about 5 minutes and lasted about 3 hours, mild left palm and arm started a prickly tingle about 10 minutes after injection and lasted 1 hour, started feeling light headed about 10 minutes after and lasted about 1 hour with no blacking out, warm flush feeling started about 5 minutes after the injection and lasted for 32 hours (did not take temperature), my chest felt very heavy and breathing was a little diminished which lasted about 20 minutes. The following morning I felt some nausea with mild dizziness that lasted about 4 hours.
53 2021-01-23 pain in extremity At around 7pm I began to feel chills, body aches, no fever, injection arm beginning to hurt. During ... Read more
At around 7pm I began to feel chills, body aches, no fever, injection arm beginning to hurt. During the night I woke up because my body was shaking from chills even thought I was under my comforter in a warm room. My injection arm was hurting more and my arm pit of the injection arm felt throbbing and painful. In the morning I still had body aches, temp 99.2, my injection arm and arm pit are painful, my arm pit was swollen. I took 1,000 mg Tylenol. Now at 03:40pm I still have body aches, arm pit still painful but not as swollen as before, chills less frequent, temp 98.4.
53 2021-01-24 burning sensation I called facility to check on everyone and see how they felt, and pt stated that her eyes looked ver... Read more
I called facility to check on everyone and see how they felt, and pt stated that her eyes looked very very red. She me a pic which I shared with. She has a burning sanitation and she bought over the counter eye drops.
53 2021-01-24 cold sweat became dizzy, clammy diaphoretic and nauseated at the end of her 15 minutes. This was her second do... Read more
became dizzy, clammy diaphoretic and nauseated at the end of her 15 minutes. This was her second dose and had no problems with the first COVID vaccine dose. Continued nausea with lightheadness and started to see visual spots when lifting head. Benadryl 25 mg 1 tab given by mouth at 1258 pm. At 1345 pm attempted to have her stand at stretcher and she continued seeing spots, dizzy. At 1406 transported to the ED for evaluation. She was seen, evaluated and released to home from the ED.
53 2021-01-24 flushing, tingling, numbness 20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a... Read more
20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a rash across my chest, headache, nausea, numbness/tingling in both hands and lightheaded.
53 2021-01-24 pain in extremity I had, on the 21st, at about 6:00 pm or so I had left arm pain (upper). On the 22nd, at 5:00 am, I w... Read more
I had, on the 21st, at about 6:00 pm or so I had left arm pain (upper). On the 22nd, at 5:00 am, I woke up with chills, body aches and fever of 99.1 and then I took Tylenol. I had taken the morning off and I waited until 9:00 to see how I was feeling and I still wasn't feeling good. I ate breakfast and took another Tylenol and I was still having body aches, chills, fever was still 99.1. Had a little bit of headache also. So I called in work to cancel afternoon patients. At 1:00, I took two Tylenols because I had increased symptoms -about 99.3 or so fever. I went to sleep and woke up at 6:30 or so and was feeling better. After that I didn't have to use Tylenol. Arm pain was less stronger than the first dose on the second day (taken on the same arm).
53 2021-01-25 burning sensation Patient was given Pfizer Covid 19 vaccine, after administration she reported having burning to her t... Read more
Patient was given Pfizer Covid 19 vaccine, after administration she reported having burning to her throat, tingling of lips and tightness on her throat. Dr. was immediately called. Orders for Benadryl 100 mg IM was given and medication was administered on right gluteus. Vital signs were taken and recorded on chart. Patient was monitored and verbalized improvement within 5 minutes of adminstration. Patient was monitored for another 30 minutes. Patient stated that she was feeling better.
53 2021-01-25 flushing, cold extremities Dizziness, lightheadedness worse upon standing, HA, sore throat, body aches, muscle aches, bone ache... Read more
Dizziness, lightheadedness worse upon standing, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, facial flushing. Missed work for 2 days and went to urgent care. Treated with APAP, Motrin, and meclizine
53 2021-01-25 flushing At 1:50 pm in post vaccine observation, patient reported metallic taste in mouth and warm flushing s... Read more
At 1:50 pm in post vaccine observation, patient reported metallic taste in mouth and warm flushing sensation from head to toe and tingling in lops. Vital signs taken at 1:50pm 158/92, pulse 71, resp 20, 1:55pm: 138/64, pulse 62, 2:05pm: 112/70, pulse 60, 2:15pm: 110/72, pulse 59, 2:28pm: 130/70, pulse 60, 2:40pm: 128/74 pulse 60, resp. 18. O2 sat remained 96-99% on room air. After 45 minutes patient reported feeling better and left with family member. Instructed to self monitor and to contact MD or report to ER if symptoms return or worsen. Patient verbalized understanding. Patient received Pfizer BioNTech Covid 19 vaccine EUA.
53 2021-01-25 pain in extremity Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; Thi... Read more
Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL0142, expiry date not reported), via an unspecified route of administration on 11Jan2021 11:30 at a single dose in the left arm for Covid-19 immunization (as patient works in a nursing home and wanted to get it). Medical history included ongoing asthma and had COVID back in Apr2020 to an unknown date. There were no concomitant medications. The patient previously had flu shot and had arm red and sore. Patient had a reaction after receiving her Covid shot yesterday at 11:30 AM. Patient mentioned that she woke up this morning (12Jan2021) at around 3 AM with chills, a headache and fever at 102-degree Fahrenheit and felt that she has to move her legs every time to feel better. She has asthma but stated that her breathing was fine. Patient wanted to know if this was normal and when this will go away. She called her doctor and left a message to let them know. She had COVID back in Apr2020, but got the vaccine yesterday, which she wanted. She was unsure what was going on. She was also shivering and cannot settle down, like her legs. She just has a massive headache with chills, shivering, and some sweating (12Jan2021). Her arm was also red and sore (12Jan2021). It was like she gets with the Flu shot, but she never has had any other symptoms with the flu shot. The events were reported as non-serious. Therapeutic measures were taken as a result of chills/shivering, fever at 102-degree Fahrenheit, headache, and arm was sore and red. Patient took Tylenol this morning when she woke up at 3 AM. She did not fall asleep until 5 AM. Then she got up at 7 AM and took some more. She will take more at 11 AM. The outcome of the events chills/shivering, fever at 102-degree Fahrenheit, headache, sweating, and arm was sore and red was not recovered.
53 2021-01-25 cold extremities, flushing Dizziness, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, dizziness w... Read more
Dizziness, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, dizziness worse when standing, facial flushing
53 2021-01-26 flushing, pain in extremity I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting,... Read more
I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting, nausea, headache, stuffiness, congestion, swelling on the arm at the injection site, pain and rash around the injection site.
53 2021-01-26 pain in extremity, numbness dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side ... Read more
dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side numbness on my face limping leaning to the left side when walking tingling on my gums and teeth
53 2021-01-26 pain in extremity Low grade fever of 101.4, achy muscles, tiredness, and cannot lift left arm above my head without fe... Read more
Low grade fever of 101.4, achy muscles, tiredness, and cannot lift left arm above my head without feeling extreme pain.
53 2021-01-26 tingling, numbness elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbn... Read more
elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy. The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
53 2021-01-27 pain in extremity Received dose # 1 at 7 pm. At 1 am woke up with severe left arm pain , and unable to move arm. Las... Read more
Received dose # 1 at 7 pm. At 1 am woke up with severe left arm pain , and unable to move arm. Lasted for 36 hours then gradually resolved. Now continues to be painful when raising arm and internal rotation .
53 2021-01-27 tremor couldn't breathe through nose, hands shaking, nausea, had elevated blood pressure and pulse when che... Read more
couldn't breathe through nose, hands shaking, nausea, had elevated blood pressure and pulse when checked. (162/104 and 122 hr)
53 2021-01-27 tremor Shaking in left arm 5-6 hours after vaccination, which later spread to abdomen and head. Felt like h... Read more
Shaking in left arm 5-6 hours after vaccination, which later spread to abdomen and head. Felt like head was vibrating or shaking on the inside, accompanied by nervous energy and feeling that something was not right. Interfered with ability to sleep. Seemed better in the morning but not completely resolved. Developed lower back/flank pain 5 days after vaccine.
53 2021-01-28 feeling cold Patient began to feel cold with severe headache and experienced nausea 5 minutes after injection. Be... Read more
Patient began to feel cold with severe headache and experienced nausea 5 minutes after injection. Benadryl was given. Blood pressure was 144/88. Patient was observed for 1 hour. Following 1 hour, she went to her office and planned to go home. Patient was later called to identify if symptoms were still occurring, but did not answer. Voicemail was left.
53 2021-01-28 migraine Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed bl... Read more
Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed blurry vison; 1/25/21 - had an e-visit ; 1/26/21 - evaluated by her PCP referred to ophthalmologist; 1/27/21 - evaluated by ophthalmologist and referred to retina specialist as she had pressure behind her eye; 1/29/21 - retina specialist used laser to decrease pressure behind her eye.
53 2021-01-28 migraine Bad headache about 45 minutes after shot. Had headaches for a few days after. Then after 3 weeks, ... Read more
Bad headache about 45 minutes after shot. Had headaches for a few days after. Then after 3 weeks, had a migraine - felt like the one I had the same day of the vaccine, but way more intense. I now wake up with headaches almost every morning.
53 2021-01-28 pain in extremity she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tigh... Read more
she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tighten, and congestion; back was hurting; she had lost her taste and smell; she had lost her taste and smell; feeling her chest tighten, and congestion; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; allergy symptoms; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (patient) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on left arm for COVID-19 immunization as COVID-19 prevention. Medical history included ongoing asthma diagnosed more than three years ago. The patient's concomitant medications were not reported. She had no other vaccines on the same day as her COVID vaccine. The patient had the first dose of the Pfizer COVID vaccine on 29Dec2020, and since then she has contracted COVID, and tested positive for it on 07Jan2021 with symptoms. She asked if she still can get the second shot on the 21st day following her first dose. When she got the vaccine, she was fine, just had a sore arm. A couple days before 07Jan2021, she developed allergy symptoms, and so on the 7th (07Jan2021), she went to get tested, and it was positive. She was 235 pounds, but since getting COVID on Jan2021, she is now 224 pounds. She reported that she started to have allergy like symptoms on maybe 05Jan2021, and on the 7th she went to get tested for COVID, because she had started feeling her chest tighten, and congestion, and her back was hurting, and she has a history of asthma, so she wanted to be seen. She confirmed that on 07Jan2021, she had a Rapid test for COVID, and the results came back the same day, as Positive. She was told that she should also have a 48-hour test, so she had that performed as well, and that one also came back positive, but she knew it would, because by then she had lost her taste and smell. The patient is scheduled for her 2nd dose 19Jan2021. She was wanting to know if she can still get the 2nd dose. She was told she needed to wait 30 days from her positive diagnosis before she could get the 2nd dose. She added that she will still be in isolation when her 2nd dose is due. Outcome of the events was unknown.
53 2021-01-28 pain in extremity This is a spontaneous report from a contactable physician (patient herself). A 53-year-old female pa... Read more
This is a spontaneous report from a contactable physician (patient herself). A 53-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced a sore arm (added that she cannot move it from the pain) for 24 hours on an unspecified date. The patient did not receive any treatment of the event. The outcome of the event was recovered on an unspecified date.
53 2021-01-28 pain in extremity mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pai... Read more
mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pain; Looked pale; was so hungry; This is a spontaneous report from a contactable physician (patient herself). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. The patient medical history included that the patient has a severe allergy cold and humidity and therefore before getting the vaccine she took an Advil and loratadine. There were no concomitant medications. The first dose of BNT162B2 for COVID-19 immunization was given on 23Dec2020 (Lot: EL0140) at the age of 53 years old and reported sore arm (added that she cannot move it from the pain) for 24 hours. In regards to the first dose, she only had a severe sore arm and couldn't elevate the arm but this only lasted for 24 hours and then she didn't have any soreness. She received the second dose on 13Jan2021 and experienced mild fever, chills, anorexia, headache, and myalgia. Her supervisor asked her to test positive for covid however she is wondering if she could get a false positive since it is still within 72 hours after vaccination. Patient asked if after vaccination do they not check for antibodies to make sure the vaccine is working. The patient reporting on COVID and who stated she got her second dose on Wednesday (13Jan2021) and who stated she has some questions about side effects and getting tested after vaccination. It was explained that she has had fevers, chills, headache, and discomfort in her chest (Jan2021). She was told to get a test by her job but wondered if she will test positive since it has been less than 72 hours since getting the vaccine. She got the second shot around 7:50pm or 8pm. At midnight she woke up with chills, mild fever, and severe muscle pain. Then she woke up in the morning early with a headache, severe muscle pain, it was very hard to make it. She had severe anorexia, she was so hungry she ate a little and went back to bed. Then she only woke up for lunch and ate something. At that time her fever was gone. She went back to bed but at 8pm she woke up and still had muscle pain. She had a very difficult time yesterday. In the night she woke up with leg pain, muscle pain. The patient explained she felt better today so she went to work and spoke to her supervisor who told her it was better to take a test for COVID. It was mentioned she looked pale and it was better for her to have a test just in case. The patient reported that she knows a bit about vaccines and the proteins and RNA. Since it has been less than 72 hours since she had the second dose, would she test positive if she had a COVID test. No treatment after the doses. Patient states she has no had any testing done at this point. Therapeutic measures were taken as a result of event so hungry. The event fever recovered on an unspecified date in Jan2021. The outcome of the events chills, anorexia, headache, discomfort in her chest and myalgia/muscle pain, leg pain, looked pale, and was so hungry was unknown.
53 2021-01-28 pain in extremity Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle ... Read more
Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle that is still present.
53 2021-01-29 burning sensation 2hrs after taking the 2nd shot of Pfizer vaccine experienced a burning sensation across my upper bac... Read more
2hrs after taking the 2nd shot of Pfizer vaccine experienced a burning sensation across my upper back and lower right back. It only lasted 10seconds but I have never ever felt something like this before. 2nd dose in the right arm.
53 2021-01-29 muscle spasms, pain in extremity Pfizer-BioNTech Covid Vaccine EUA On 1/29/2021, Fasiculations started in both legs (below the knees)... Read more
Pfizer-BioNTech Covid Vaccine EUA On 1/29/2021, Fasiculations started in both legs (below the knees) at 7pm, 5 hours after the shot. The gnarly, very painful cramps of my feet and ankles started in the right foot at 7:30pm.....last about 10-12 minutes, then the left foot/ankle, again for 10-12 minutes. I have and took Gabapentin 600 and had relief from the cramps by 9:30pm. The fasiculations continued for 24 hours. At this point (25 hours later) my feet and ankles have a dull ache but I do not expect anymore cramps. This is an autoimmune disease for me but I have not had an episode this bad in a year. PS - It?s worth it to take the vaccine!
53 2021-01-30 tremor, burning sensation, tenderness ? Jan 21st, 2 hours after vaccine headache. 12 pm right side of back hurting last 2 hours, 3 pm nec... Read more
? Jan 21st, 2 hours after vaccine headache. 12 pm right side of back hurting last 2 hours, 3 pm neck hurting lasts 2 hours.6pm feet are burning hot to the touch. ? Jan 22, 12 am Arrhythmias, racing heart rate, uncontrollable shaking, throat is feeling sore and difficulty swallowing. I go to the ER . While waiting to see a doctor my symptoms subside. Dr. prescribes an epi-pen. Explains that they do not know about the vaccine. ? Jan 23, 3am uncontrollable shaking, neck hurting feet burning. 4am nausea, headache still continues. ? Jan 24, massive headache continues, nausea, diarrhea, I go to Urgent Care Center. They do a blood test must wait a few days for results. ? Jan 25, Massive headache continues, uncontrollable shaking ? Jan 26, 2am, headache continues, uncontrollable shaking, burning feet, blood pressure 164/103. Back to Urgent care. Add blood pressure meds. ? Jan 29, 12 am Shaking, blood pressure168/85 ? Jan 31st Sunday 7pm, Muscles tightening up in lower body, chest pain Symptoms ongoing, Doctors do not know enough about the vaccine to treat the problem.
53 2021-01-31 discomfort tested positive later in the day; tested positive later in the day; exposed to someone with covid vi... Read more
tested positive later in the day; tested positive later in the day; exposed to someone with covid virus; headaches in the back of head and ears; heaviness, it seems like pressure; Fever/101.6; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration, administered to the left deltoid, on 14Jan2021 between 2:30-2:45pm (14:30-14:45) at single dose for COVID-19 immunisation. It was offered at her worksite. The patient's medical history included ongoing Baker's cyst right knee. The patient had no family history. Concomitant medication included celecoxib (CELEBREX) from May2020 for Baker's cyst. The patient had no additional vaccines administered on the same date of the BNT162B2. The patient previously took flu shot and she got sick (in the 1980's or 1990's). The patient had no prior vaccinations that were within 4 weeks prior to the first administration date of BNT162B2. The patient, a Senior facility HCP, took a covid test on Monday and was negative. Yesterday (14Jan2021), she received the first dose and then tested positive later in the day. She wanted to know if she can get the next dose at the appropriate time or if she has to wait 90 days. On 14Jan2021, the patient experienced headaches in the back of head and ears, heaviness, it seems like pressure, fever, and exposed to someone with covid virus. It was reported that the patient was debating on getting the Pfizer BioNTech Covid vaccine and so she finally decided to get it yesterday (14Jan2021). Two hours after getting it and getting home, her head started to hurt and fever, which she thought that was typical. That night the fever broke and it started again this morning (15Jan2021). She works at a senior facility and had to ask for an extended medical leave. She was tested yesterday for Covid that morning and had the vaccine in the afternoon. She was exposed to someone with the virus. She knows there are 2 shots and now she has had the one. She wanted to know if it's safe to get the second one since someone said she may need to wait 90 days since being exposed. She still has the headaches in the back of head and ears, heaviness, it seems like pressure. The fever has been under 100, it's been about 99 and the highest it got was yesterday at 101.6 degrees. By the time she went to bed last night it got down to 98.2 degrees. She has alternated Advil and Tylenol. She took temperature at 6am today (15Jan2021) and it was 99.8 and so she took a couple of Advil to help and by 7am it was down to 99.2. So, it's staying in the 99.2-99.3 range. The patient did not receive any other vaccines the same day or 4 weeks prior. The patient mentioned when getting the her very first flu shot, which she was hesitant about getting, she did get sick, but it wasn't immediately after. Since then she has been fine. She thinks this was in the 1980's or 1990's. She mentioned that this is a new vaccine and there is not a lot of information out there. She wanted to know if she will get immunity right away. She mentioned she was tested on Monday for Covid and told if she didn't get a call she was fine and she didn't hear anything. Then was told yesterday she was exposed to someone with Covid and so she had testing again yesterday. She is awaiting results (pending clarification). No further details provided. She was diagnosed around Memorial Day last year for right knee baker's cyst and given celecoxib. She went through physical therapy and has full range of motion, but cyst still there and tender. She may see a rheumatologist. She just finished her 30 days of celecoxib and didn't see any difference. It was reported that the events did not require a visit to emergency room nor physician office. The outcome of the event " tested positive later in the day" was unknown while the outcome of the events headaches in the back of head and ears, heaviness, it seems like pressure, fever, and exposed to someone with covid virus was not recovered.; Sender's Comments: The reported tested positive on the same day that the patient received first dose of COVID 19 vaccine, BNT162B2, is considered unlikely related to the suspect. Of note, the patient exposed to someone with the virus.
53 2021-01-31 pain in extremity swelling and pain of first digit phalangeal-metacarpal joint, R hand, index finger (same side as va... Read more
swelling and pain of first digit phalangeal-metacarpal joint, R hand, index finger (same side as vaccine received)
53 2021-01-31 pain in extremity Fever, pain on left arm, body aches, back pain Used Tylenol , fever subsided on 1/30 pm but back p... Read more
Fever, pain on left arm, body aches, back pain Used Tylenol , fever subsided on 1/30 pm but back pain continued lightly and constant throughout 1/31/21. Flank pain (moderate) began on 2/1/21, consistent/current
53 2021-01-31 tingling, weakness not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she wa... Read more
not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she was going to pass out; Fever; Nausea; tingling on her face; This is a spontaneous report from a contactable consumer (patient). A 53 years old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date Apr2021) via Intramuscular on 14Jan2021 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history heart murmur and high blood pressure diagnosed about 10 years ago. The concomitant medications was reported as none. Patient was still not feeling good. She said that she had side effects that started on Saturday 16Jan2021. Caller clarified that she had fever, nausea, and tingling on her face. Fever was noticed it on Saturday 16Jan2021 and gone by about 2am on Sunday 17Jan2021. Patient stated that she was feeling real thirsty. Nausea was still there and this morning, patient felt like she was going to pass out. She stated that she had weakness. She stated that she is trying to make an appointment to see her doctor. She stated that the nausea is persisting, but the nausea comes and goes. She stated that yesterday she felt ok, but this morning, she felt nauseated and like she was going to pass out. Patient said that the tingling stopped around 17Jan2021 02:00 along with the fever. Patient stated that she is drinking Gatorade and eating crackers and is staying stay hydrated. She stated that she is at work, but she feels weak. She stated that she had chills and she hurt like someone had hit her. She noticed these symptoms on Saturday 16Jan2021 and stated that this was ongoing and they come and go. The outcome of fever and tingling on her face was recovered on 17Jan2021 02:00. The outcome of not feeling good and feeling real thirsty was unknown. The outcome of other events was not recovered.
53 2021-01-31 tremor, tingling could not get out of bed; whole body aches; shaking; significant nausea; significant dizziness; head... Read more
could not get out of bed; whole body aches; shaking; significant nausea; significant dizziness; headaches; immediate reaction up to jaw, ear and shoulder/ she felt it on the left side of her jaw and her left ear, and down her arm and it was tingling down her hands; not feeling well; very stressful; This is a spontaneous report from a contactable consumer for herself. A 53-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) intramuscularly at upper left arm, 12:45PM on 08Jan2021 to prevent Covid. The patient had no medical history. She did not get sick and had not taken a sick day in 5 years. Patient had not received other vaccines within four weeks. Patient had no concomitant medications. The patient had an immediate reaction up to jaw, ear and shoulder following first dose on 08Jan2021. When she got the injection, she could feel the stuff going in and something on the left side of her jaw, and she brought her right hand up to rub her jaw. She was not sure if a nerve may have been hit, but she felt it on the left side of her jaw and her left ear, and down her arm and it was tingling down her hands. This has recovered completely at the time of reporting. She had not been feeling well since that day and got worse. On Wednesday (13Jan2021), it started with significant dizziness and her headaches started toward the end of day. By Thursday (14Jan2021) she had the headache and significant nausea. The body aches started on Thursday. Her whole body ached so much that she was shaking. On Friday (15Jan2021) she could not get out of bed since the headache was intense along with the dizziness and nausea. She received Advil and Tylenol as treatment and was also taking clonazepam since it had been very stressful. She was worried since she felt safe going in to get the vaccine and she did not feel so safe now. At the time of reporting, she improved but not recovered. She would like to know what she is experiencing is a side effect or if she should be tested for Covid. The outcome of tingling feeling resolved, stressful was unknown and outcome of other events was resolving. Information on the lot/batch number has been requested.
53 2021-02-01 burning sensation Employee reported that she began dry, burning lips and neck which started day after covid vaccine ad... Read more
Employee reported that she began dry, burning lips and neck which started day after covid vaccine administered. On day 2 following vaccine, employee reported lips began to swell and rash and hives developed on neck and chest. Lip swelling resolved on 1/31/2021 and employee still has rash on chest and neck, but is improving. Employee was using Benadryl cream for rash and itching and was also taking Benadryl orally 50 mg at bedtime and was taking Claritin during day. Did not have to seek emergency treatment but did miss 1 day of scheduled work. Employee is also reporting fatigue and pain in joints. Has a hx of lupus and RA and believes vaccine may have caused a flare.
53 2021-02-01 facial pain, numbness Systemic: Chills, Systemic: Joint Pain, Systemic: Other- Pain and numbness on the left jaw/face-Seve... Read more
Systemic: Chills, Systemic: Joint Pain, Systemic: Other- Pain and numbness on the left jaw/face-Severe.
53 2021-02-01 facial paralysis Bell's Palsy; This is a spontaneous report from a contactable other HCP (patient). A 53-years-old fe... Read more
Bell's Palsy; This is a spontaneous report from a contactable other HCP (patient). A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL 3247), via an unspecified route of administration at Left arm on 15Jan2021 11:00 AM at SINGLE DOSE for covid-19 vaccination. The patient was not pregnant. Concomitant medications in two weeks included lithium, levothyroxine sodium (LEVOTHROID), omeprazole. Historical Vaccine included first dose of bnt162b2 (lot number EL 1284) on 29Dec2020 11:00 AM at Left arm for covid-19 vaccination. The patient previously took ziprasidone hydrochloride (GEODON) and experienced drug allergies. It was reported no other medical history. On 17Jan2021 the patient woke up with left side of her face dropping. She went to the ER. She was diagnoses with Bell's Palsy. The event onset date was 17Jan2021 04:00 AM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment drugs predizone and Acyclovir received for the event. The outcome of the event was not recovered. No covid prior vaccination, no covid tested post vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
53 2021-02-01 facial paralysis Facial swelling, itching, tightness, eyelid dropping
53 2021-02-01 feeling hot, pain in extremity after vaccine experienced very sore arm couldn't hold anything, body aches and joint pain felt like ... Read more
after vaccine experienced very sore arm couldn't hold anything, body aches and joint pain felt like I had a fever but did not, extreme fatique
53 2021-02-01 numbness Complained of feeling "off and feeling like legs are falling asleep" and upset stomach. at 14 35 ... Read more
Complained of feeling "off and feeling like legs are falling asleep" and upset stomach. at 14 35 BP 179/102, Pulse 73, 98% on room air. Rested for approximately 45 mins. Bp 171/95 at 1455. Patient reported feeling better and agreed to follow up with primary MD or go to ER is symptoms worsened.
53 2021-02-01 tremor Approx. 25 mins after receiving vaccine. I experienced rapid heart, shaking, elevated BP. I was lea... Read more
Approx. 25 mins after receiving vaccine. I experienced rapid heart, shaking, elevated BP. I was leaving the hosp. and started feeling strange and my heart was racing and I felt shaky. I went to the ER at the hospital I received my vaccine at.
53 2021-02-02 cold sweat, feeling hot 23 minutes following administration of vaccine began feeling nauseous, clammy, warm. Evaluated patie... Read more
23 minutes following administration of vaccine began feeling nauseous, clammy, warm. Evaluated patient BP 98/62 RA, wnl per pt. P 77, RR 16, O2sat 95-97%. During evaluation pt stated felt slightly itchy throat and itching in her ears. Pt given Claritin 10 mg po at 12:19 pm and remained under observation by RN. Pt began feeling better, sipping water. P 88-91, RR 16, O2sat 98%. Reviewed pt status with MD. Pt allowed to leave at 12:35 pm.
53 2021-02-02 feeling cold Woke up out of my sleep feeling horrible. For about 2 hours, from 3am until about 5am I was very col... Read more
Woke up out of my sleep feeling horrible. For about 2 hours, from 3am until about 5am I was very cold with excessive sweating and nausea. Did not vomit, but felt like I would and should. I had explosive diarrhea 4 times, each time thinking I was done, but then urgently having to go again. After the 4th time, I felt completely empty. During those 2 hours I felt horrible and was scared for the fact that I knew it was a result of the vaccine 12 hours earlier. I was able to get back to sleep and felt better the next day. I was tired, but not feeling sick for the rest of the day. I was 100% better the following day.
53 2021-02-02 flushing, tingling Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in che... Read more
Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in cheeks, throat tightness and lethargy
53 2021-02-03 weakness fever 101; headache; chills; muscle pain; weakness; nausea; fatigue; This is a spontaneous report fr... Read more
fever 101; headache; chills; muscle pain; weakness; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on an unspecified date at 10:00 at single dose on left arm for COVID-19 immunisation. Medical history included depression/anxiety, back pain, COVID prior vaccination and known allergies: sulfa and penicillin. Concomitant medication included naproxen, sertraline HCL (ZOLOFT), fish oil, ospemifene (OSPHENA) and docusate sodium (COLACE), all from unknown date for unknown indication. On 12Jan2021 at 17:00, patient experienced fever 101, headache, chills, muscle pain, weakness, nausea and fatigue. Events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. Nasal Swab on 14Jan2021 was negative. Patient recovered in Jan2021. Information on the lot/batch number has been requested.
53 2021-02-03 difficulty speaking, pain in extremity DROWSY ITCHY THROAT (STARTED HERE) ITCHY NOSE (PROGRESSED HERE) GENERALIZED ITCHING EVERYWHERE (ENDE... Read more
DROWSY ITCHY THROAT (STARTED HERE) ITCHY NOSE (PROGRESSED HERE) GENERALIZED ITCHING EVERYWHERE (ENDED HERE) NUMB LIPS AND TONGUE THROAT HOARSE LEFT ARM ACHE
53 2021-02-03 pain in extremity, numbness first shot my arms and neck muscles went numb for several hours Second time my legs were in severe ... Read more
first shot my arms and neck muscles went numb for several hours Second time my legs were in severe pain and hard to make move-could barely walk. This lasted for about 8 hours. I had a small fever, my left leg and ankle swelled for several days and hurt mildly. I had a rash on my neck and body. I had fatigue like theonset of a fibro attack both times but second shot was much worst than first.
53 2021-02-03 pain in extremity arms pain, back pain, spine pain 4 hours only. pain dropped to lower back and hips and lasted for a ... Read more
arms pain, back pain, spine pain 4 hours only. pain dropped to lower back and hips and lasted for a few hours. Recurring pain since.
53 2021-02-03 pain in extremity Arm was getting sore and stiffing and as days went on till after second shot was seen by ED, and PT ... Read more
Arm was getting sore and stiffing and as days went on till after second shot was seen by ED, and PT have not Frozen shoulder Shot was close to Shoulder capulituits . I have received yesterday 2/3/2021 a cortisone shot to the shoulder and will receive PT
53 2021-02-04 feeling cold, muscle spasms, weakness She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrena... Read more
She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrenal glands are over compensating, working over load; she was having diarrhea; throwing up; she went from cold to profusely sweating back to having chills; she went from cold to profusely sweating back to having chills; she had no blood to her extremities; severe abdominal cramps; headache; her body is just weak; she was feeling dizzy; Her legs were cramping; her heart was racing fast; her lactic acid was really high; This is a spontaneous report from a contactable Nurse. A 53-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL3249) vaccine , via an unspecified route of administration in the right deltoid on 13Jan2021 15:55 at single dose for Covid-19 immunisation . Medical history included hypertonic bladder from an unknown date., drug hypersensitivity from an unknown date , migraine from an unknown date. She had migraines. Concomitant medication included solifenacin succinate (VESICARE), buspirone hydrochloride (BUSPAR), spironolactone (SPIRONOLACTONE). The patient previously took flu vaccine VII, bactrim and experienced drug hypersensitivity. The patient stated she thinks she had a delayed anaphylactic shock she was definitely in shock on an unknown date with outcome of unknown , hypothermic on an unspecified date with outcome of unknown , her adrenal glands are over compensating, working over load on an unspecified date with outcome of unknown , she was having diarrhea on an unspecified date with outcome of not recovered , throwing up on an unspecified date with outcome of unknown , she went from cold to profusely sweating back to having chills on an unspecified date with outcome of unknown , she had no blood to her extremities on an unspecified date with outcome of unknown , severe abdominal cramps on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of not recovered , her lactic acid was really high on 18Jan2021 with outcome of unknown , her body is just weak on an unspecified date with outcome of not recovered , her heart was racing fast on 18Jan2021 with outcome of unknown , she was feeling dizzy on 22Jan2021 with outcome of unknown , her legs were cramping on 19Jan2021 with outcome of unknown. The patient was hospitalized because of the events from 16Jan2021 to 17Jan2021. The patient underwent lab tests and procedures which included blood lactic acid: high on unknown date, chest x-ray: unknown results on unknown date, computerised tomogram: unknown results on 18Jan2021 , electrocardiogram: unknown results on unknown date. The patient was given fluids, Toradol and Xanax to treat the events. Further information has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
53 2021-02-04 feeling hot Felt very hot after getting vaccine: drinking water> Then tasted metallic taste; BP slightly elevate... Read more
Felt very hot after getting vaccine: drinking water> Then tasted metallic taste; BP slightly elevated 160/90; no other issues.Monitored; hot resolving, metal taste resolving
53 2021-02-04 numbness, tingling, muscle twitching, muscle spasms 1/6/21 Twitching in left eybrow and eyelid 1/16/21 Started with fatigue in legs, over next couple o... Read more
1/6/21 Twitching in left eybrow and eyelid 1/16/21 Started with fatigue in legs, over next couple of days muscle aches all over, bone pain, fatigue, 1/18 First Covid Test 1 Negative Continued symptoms 1/21 Went to PCP Covid rapid and Covid lab both negative Labs drawn all within normal limits Symptoms continued including occasional leg cramps, random muscle twitching, sharp needle like pain in foot, feeling shaky, waking to numbness hands
53 2021-02-04 night sweats Nausea, headache, severe muscular and joint aches, night sweats, weird dreams, golf ball size red c... Read more
Nausea, headache, severe muscular and joint aches, night sweats, weird dreams, golf ball size red circle at injection site warm to touch, itchy with lump under skin.
53 2021-02-04 tingling, numbness 7 days following 1st vaccine started with aches and pains in muscles and joints. At 9 days following... Read more
7 days following 1st vaccine started with aches and pains in muscles and joints. At 9 days following 1st vaccine started having numbness/tingling and pins and needles in tips of toes and fingers. Over the next week this progressed into my feet and hands and is now up to my ankles and wrists. The aches and pains slowly got better, but did not resolve and worsened following second vaccine 2/4/21
53 2021-02-05 weakness abdominal cramping x1day, vomiting, diarrhea x1day , upset stomach unable to eat x3days, weakness ... Read more
abdominal cramping x1day, vomiting, diarrhea x1day , upset stomach unable to eat x3days, weakness x2days, fatigue x4days, fever 102.6 x 1day, chills x1day.
53 2021-02-07 feeling cold, weakness Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for va... Read more
Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for vaccines, but did not this time due to recommendation of not doing so with this vaccine. One hour post vaccination, developed cognitive changes- deer in the headlight, unable to think/process information, lasting 4-5 hours. Later that evening, extreme fatigue. Resting respirations labored >20/min lasted most of the night along with chills with no fever x 3days. Dizziness with LOUD ringing in R ear started around 1-2am and lasted one week. Pain in joints/muscles of jaw. Next day both ears were hurting inside (eardrum, middle ear) x1week. HR elevated up to 135 bpm walking to bathroom x 2 days post vaccination. Felt sick/wiped out post vaccine for 3-4 days with no energy with muscle aches/stiffness.
53 2021-02-08 difficulty speaking her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that fel... Read more
her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported. The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.
53 2021-02-08 feeling hot Medical Complaint: Employee. I got my 2nd COVID vaccine on 01/29/2021. Feeling warm, low grade fever... Read more
Medical Complaint: Employee. I got my 2nd COVID vaccine on 01/29/2021. Feeling warm, low grade fever, congestion, runny nose, cough-clearing my throat. Had chills, not over 100.0 for my fever. What should I do? Got tested for COVID on 01/08/2021
53 2021-02-08 pain in extremity After receiving my vaccine, I had the normal arm soreness and low grade fever but the following day ... Read more
After receiving my vaccine, I had the normal arm soreness and low grade fever but the following day my fever went up to 102 even after taking Advil every 6 hours. On the 3rd day my arm continued to be sore and my fever continued but was between 100.7 and 101.4. On day 4 my fever started going down to 99 for the day but my arm continued to be sore where the injection was and my armpit was sore as well like something was swollen. Day 5, today, my fever finally broke but my arm has a red circle and knot where the injection was given, its still very sore and also itches and warm to the touch. Every time I raise it up, I get shooting needles in the area of the shot. I have severe fatigue and sweats when I get up to walk anywhere and I feel exhausted. I called and spoke to the nurse who spoke to my Dr. listed on this form. She told me all of my symptoms were normal and said that if I started throwing up or my arm got worse to call back. I was not asked to come in to have anyone look at my arm or see if there is something else going on with the symptoms I am having.
53 2021-02-09 difficulty speaking my system felt ramped up; my voice sounded worked up; I had slightly shallow breathing; My heart rat... Read more
my system felt ramped up; my voice sounded worked up; I had slightly shallow breathing; My heart rate went up, not extremely high but and EMT said it felt "racy".; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: RL3249) at left arm on 21Jan2021 12:15 AM at single dose for COVID-19 immunization. Medical history included asthma, allergies to sulfa, dairy, egg, peanuts. Patient is not pregnant. Other medications in two weeks included low dose naltrexone and salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) and Herbals. No other vaccine in four weeks. Patient previously took erythromycin and epinephrine and had allergy to them. Within 5 minutes (21Jan2021 12:15 AM), her system felt ramped up. Her heart rate went up, not extremely high but and EMT said it felt "racy". She was told that her voice sounded worked up. she had slightly shallow breathing. It lasted about 30 minutes then began to subside. The next day she felt it somewhat. she was totally normal after 12 hours. She had a sensitivity to epinephrine and the Pfizer dose reaction reminded her of a milder version of the epinephrine reaction. No Covid prior vaccination, no covid tested post vaccination. No treatment received for the events; patient was recovered from the events in 22Jan2021.
53 2021-02-09 numbness After 5 minutes of receiving the vaccine the patient c/o having numbness from the site of injection ... Read more
After 5 minutes of receiving the vaccine the patient c/o having numbness from the site of injection up her neck and face. Neuro assessment WNL, Vital signs WNL. Patient left clinic after 30 minutes of observation, denied need to go to ER for further workup.
53 2021-02-09 speech disorder Due to Lupus I typically have very slow matabolism, low appetite and sluggish, however after a few ... Read more
Due to Lupus I typically have very slow matabolism, low appetite and sluggish, however after a few hours of receiving the vaccine I experieinced unusual restlessness, pacing, high energy, fast speech and incredible appetite ( I had 3 separate meals in 2.5hrs as opposed to my usual 1 meal a day. My family were the one's who first noticed the change. However next day I was back to my usual self. I thought it was important to share as I anticipated due to lupus that my exposure to a foreign vaccine would have caused the more common symptoms but it was quiet opposite and unusual.
53 2021-02-09 tremor Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling... Read more
Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 23Jan2021 (11:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included early diabetes and high blood pressure. Concomitant medications included valsartan, sitagliptin (JANUVIA) and rosuvastatin. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 02Jan2021 (when the patient was 53 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 23Jan2021 (19:00), the patient had chills; body aches; injection arm had begun to hurt; body tremble; armpit was very painful; and armpit was swelling. The patient had no fever. The patient had taken paracetamol (TYLENOL) as treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'injection arm had begun to hurt', 'body tremble', 'armpit was very painful' and 'armpit was swelling', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
53 2021-02-11 burning sensation, tingling, weakness, pain in extremity Chronic pain up into shoulder blades and lower neck all the way down to the lower arm and finger tip... Read more
Chronic pain up into shoulder blades and lower neck all the way down to the lower arm and finger tips. Some tingling also. Burning, constant pain. Inable to lift over 10 pounds. Suspect it is the Brachial Plexus. Still having symptoms 2 weeks after the vaccination
53 2021-02-11 unresponsive to stimuli PATIENT REPORTED SYNCOPE TO CHILDHOOD IMM., BUT NOT RECENT FLU SHOT. PATIENT WAS OBSERVED TO BE FINE... Read more
PATIENT REPORTED SYNCOPE TO CHILDHOOD IMM., BUT NOT RECENT FLU SHOT. PATIENT WAS OBSERVED TO BE FINE FOR 20 MINUTES POST-VACC. SHE WAS ON HER WAY HOME AT 50 MINS. POST-VAC WHEN SHE BECAME UNCONSCIOUS, UNRESPONSIVE, & PRESENTED W/HIVES. SHE WAS TREATED AT EMERG. DEPT. AFTER 90 MIN, SHE IS CONSCIOUS & IMPROVING.
53 2021-02-12 migraine Fever, chills, migraine headache for 1 day. I slept and laid with 3 blankets and a heating pad.
53 2021-02-12 pain in extremity Fever, body aches, shivering, pain in arm
53 2021-02-13 weakness Symptoms started January 21,3021 with Fever, Chills, Bodyaches, Weakness and Exhaustion. Symptoms c... Read more
Symptoms started January 21,3021 with Fever, Chills, Bodyaches, Weakness and Exhaustion. Symptoms continued January 22 and I was unable to go to work. Bodyaches , Weakness and Stomach Pain an Nausea occurred for another week . Shoulder and Back Pain with intermittent Headaches and Neck Pain continues currently as of today?s date 2/14/2021
53 2021-02-14 weakness, tingling Rash, lightheadedness, weakness and tingling, throat closing, elevated blood pressure
53 2021-02-14 feeling hot, weakness Pfizer-BioNTech COVID-19 Vaccine Employee complained of feeling hot, tongue felt swollen, and weak... Read more
Pfizer-BioNTech COVID-19 Vaccine Employee complained of feeling hot, tongue felt swollen, and weak. Patient was taken to Clinic for evaluation at onset of symptoms, approx 12 minutes after distributing vaccine. At Clinic, patient states her symptoms have improved. She states she thinks she got a little anxious and feels comfortable driving home at this time. Patient denies oral/throat/tongue/lip edema. No headache, vision changes, difficulty swallowing, difficulty handling oral secretions, chest pain, palpitations, shortness of breath, nausea/vomiting. No pruritus. Patient is siting comfortably in the chair and drinking water without difficulty. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss the second dose of the covid vaccine. Patient agreed to the plan. Patient ambulated out of clinic without difficulty. 1/1/21: Pt received 2nd dose of vaccine. Experienced some dizziness and slightly high BP. Both symptoms resolved within 30 minutes and patient was discharged home.
53 2021-02-14 numbness, tingling reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingl... Read more
reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingling in right thumb; numbness and tingling in right thumb; EKG abnormal; large bruise on right buttock/right thigh/right arm; Chest discomfort; Heart attack; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 06Jan2021 (at the age of 53-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced electrocardiogram (EKG) abnormal and large bruise on right buttock/right thigh/right arm on 08Jan2021; numbness and tingling in right thumb on 10Jan2021; reddened area with bruising with nodule on 26Jan2021; chest discomfort and heart attack in Jan2021. The clinical course was reported as follows: Two days later after vaccination, she noticed bruising on various parts of body. The first bruise she noticed on the 08Jan2021. It was probably about 3.5 inches in length 2 inches in width. The patient stated that it did not necessarily have a shape. She had a large bruise on her right buttock. Two days later, she noticed a similar in size bruise on the front of her right thigh. Then a couple days later, she noticed three quarter size bruises on her right arm (two on the inner part of arm, and one on the outer, both on upper arm). The very next day, she developed the same sizing bruise. It was about the same size on her left upper arm. There were no other side effects besides the bruising. There was no itching or redness, no skin, respiratory, or neurological issues. The day before her second dose, on 26Jan2021, she noticed a 4 inch reddened area with a two centimeter nodule inside that bruise. The patient stated that the initial bruises began to heal. They are not as dark as they were. They were reported to have started out red and then turned black and blue. The patient also had numbness and tingling in her right thumb. She was having some chest discomfort after the initial vaccination that is still ongoing. The chest discomfort prompted her to go to urgent care on 08Jan2021, where she had an abnormal EKG on 08Jan2021. The patient was told to follow up with a cardiologist. The patient saw the cardiologist on 25Jan2021, where he did an EKG and ECHO. The EKG was abnormal and ECHO with unknown results on 25Jan2021, but the doctor was unable to determine when the heart attack occurred. The cardiologist also ran labs: a troponin to see if anything was acutely going on, and a D Dimer to evaluate her clotting factors; both were negative on 25Jan2021. The cardiologist recommended a computerised tomogram (CT) scan, which was still scheduled at the time of report. The clinical outcome of large bruise on right buttock/right thigh/right arm, chest discomfort, numbness and tingling in right thumb, and reddened area with bruising with nodule was not recovered and of heart attack and EKG abnormal was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
53 2021-02-14 migraine Headaches and Migraines and vomiting, Maxalt 10 mg Tylenol
53 2021-02-14 seizure, weakness, numbness Initially reported numbness and tingling of lips and ringer after first dose of vaccine. She was giv... Read more
Initially reported numbness and tingling of lips and ringer after first dose of vaccine. She was given Benadryl 50mg IM. Within 15 seconds she reported not feeling well. Then she started seizing for about 30 seconds. Initial BP 148/88 and pulse ox 98. After 5 mins BP of 125/77 and pulse ox 99%. Patient regained consciousness, was A&O x3 but felt weak/tired. She was transported to the hospital.
53 2021-02-15 feeling cold, pain in extremity Sore arm, body aches, low grade temp, chills day after. On the 8th, I woke to cold sensation down l... Read more
Sore arm, body aches, low grade temp, chills day after. On the 8th, I woke to cold sensation down left cheek under eye, across lips and some chin, into nasal cavity. Has lasted a week so far and has not resolved. Also a continuous headache, worse when lying down. Tylenol eases it but never has gone away.
53 2021-02-15 numbness Facial numbness within 2 hours of administration with resolved within the hour.
53 2021-02-16 weakness, tremor, feeling cold Chills - violent shaking for 3 hrs Headache - 3 days weakness - 3days
53 2021-02-16 tremor patient reports shaking and feeling like she can't breath (more like panic attack not anaphylaxis)
53 2021-02-17 feeling of body temperature change Injection site was moderately sore; I felt extremely tired and fatigued; chilled to the bone alterna... Read more
Injection site was moderately sore; I felt extremely tired and fatigued; chilled to the bone alternating with hot spells; This is a spontaneous report from a contactable consumer. A 53-year-old female consumer reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), into the left arm on 29Jan2021 at 10:30 at single dose for COVID-19 immunization. Age at vaccination 53 Years. The patient had received first dose of BNT162B2 on 09Jan2021. The patient had no allergies to medications, food, or other products. Medical history was none. Concomitant drugs included Prozac daily and Lyrica one daily. The patient reported that the injection site was moderately sore. The main side effect started 24 hours post shot. She felt extremely tired and fatigued as well as chilled to the bone alternating with hot spells. No body aches. No other effects. No treatment was received. Resolved in 24 hours.
53 2021-02-18 pain in extremity, nerve pain delayed adverse reaction to vaccine. experiencing severe neuropathy along my left arm. pain is prima... Read more
delayed adverse reaction to vaccine. experiencing severe neuropathy along my left arm. pain is primarily focused around my elbow to wrist area and then less on the upper arm area. Pain is present daily and I feel it most when I'm resting, relaxing and driving. I also feel pain in the Ulna area when Im typing at my computer at work. I've self medicated with motrin and topical analgesics. cold and hot compresses. give me some relief but pain comes back in a few hrs. I contacted my Doctor on Thursday 2/18/21 and she has recommended PT
53 2021-02-18 tingling, pain in extremity Vital signs: 124/74 right arm, HR 75, Pulse ox room air 99% Patient presented for 1st dose of COVID-... Read more
Vital signs: 124/74 right arm, HR 75, Pulse ox room air 99% Patient presented for 1st dose of COVID-19 Pfizer Vaccine. Post vaccination patient noted left arm pain to elbow and left supraclavicular swelling moving laterally. Noted tingling and pain then swelling in left neck/shoulder area. About size of a baseball. Patient given option to take benadryl 25 mg once before leaving or take it later if she is not improving. She prefers to take it now. Benadryl 25 mg PO x1 given at 1715 self-administered. Patient monitored for a total 40 minutes before being released. History of reaction to flu vaccination that resulted in arm swelling and high fever ~30 years ago. Vancomycin life threatening reaction.
53 2021-02-19 weakness Prolonged fever, headache, fatigue, gen weakness, vomiting/diarrhea
53 2021-02-19 difficulty speaking Hoarse Voice, hives; benadryl, IM epinephrine, pepcid, and dexamethasone given.
53 2021-02-19 difficulty speaking Patient received 2nd dose of COVID 19 Vaccination at approximately 0800, 20 Feb 2021. While seated ... Read more
Patient received 2nd dose of COVID 19 Vaccination at approximately 0800, 20 Feb 2021. While seated in observation area patient began to experience difficult swallowing and a hoarse voice. 0.3 mg epinephrine administered, 4 mg Decadron IM and 25 mg diphenhydramine PO provided at 0830. Patient transported to local ER for further evaluation and care.
53 2021-02-19 pain in extremity fatigue, chill, arm pain
53 2021-02-20 numbness Inlarged and sore lymph gland left armpit. If I lay on left side experienced numbness in left arm an... Read more
Inlarged and sore lymph gland left armpit. If I lay on left side experienced numbness in left arm and hand.
53 2021-02-21 flushing Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with fl... Read more
Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contactable nurse(patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 02Feb2021 11:45 AM at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient received the first dose of BNT162B2 on 15Jan2021 for covid-19 immunization and experienced syncope. The patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) methylfolate and Ma. The patient experienced syncope after injection in Feb2021. A few episodes in 18 hrs, the patient experienced headache, body aches, intermittent fevers with flushing/chills, nausea night of 2nd injection and next day in Feb2021. The patient experienced severe fatigue, joint pain, felt very ill, akin to the flu in Feb2021.No treatment received for the adverse events. The patient underwent lab test included body temperature: intermittent fevers in Feb2021.The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to the event syncope is possible based on available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
53 2021-02-22 discomfort Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure w... Read more
Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure was out of control; dizziness does not allow her to go to work; lingering dizziness; Get a tightening in her chest; Fatigue; Left side of temple toward the crown of head she has pressure on the left side of the body; Left side of temple toward the crown of head she has pressure on the left side of the body; lightheadedness; troponin kept increasing; Inflammation around heart; This is a spontaneous report from two contactable consumers or other non health professional (including patient self, a healthcare worker works with patients with lymphomas, a licensed massage/lymphatic therapist). This 53-years-old female received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expiry Date: 30Apr2021) at 0.3 ml single dose intramuscular injection in left arm on 22Jan2021 10:28 (also reported as 10:38) for Covid-19 vaccination. Medical history was none (also reported as no patient history). Concomitant drug was none (reported as no other products). Family Medical History Relevant to AE(s) was none. Historical vaccine included flu shot in Nov2020 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No other vaccines given the same day or 4 weeks prior. AE(s) following prior vaccinations was none. Patient never had a reaction to any vaccine or shot before. Patent experienced anaphylactic reaction on 22Jan2021, heart enzymes elevated on 22Jan2021, blood pressure was out of control on 22Jan2021, get a tightening in her chest on an unknown date, lingering dizziness on an unknown date, dizziness did not allow her to go to work on an unknown date, inflammation around heart on 22Jan2021, troponin kept increasing on 22Jan2021, fatigue on an unknown date, lightheadedness on an unknown date, left side of temple toward the crown of head she has pressure on the left side of the body on an unknown date. Seriousness for heart enzymes elevated and anaphylactic reaction was hospitalization from 22Jan2021 to 23Jan2021. The events anaphylactic reaction required a visit to Emergency Room, but not Physician Office. The event clinical course was as follows: patient received her 1st dose of the Pfizer vaccine she had an anaphylactic reaction. She was given 3-4 Epis on site (on 22Jan2021) before being transferred to the ER. In the ambulance, she was administered a 4th EpiPen (on 22Jan2021) before getting to the ER, and then admitted to the cardiac unit on 22Jan2021 for observation. Patient also reported Given 3-4 EpiPens on 22Jan2021 and EpiPen auto-injector was Lack of Effect. No Return Sample Received. When she first started having symptoms, her blood pressure was 128/73. When the symptoms got worse her blood pressure started increasing. Her blood pressure was 220/116, they had to admit her to the cardiac unit because her heart enzymes were elevated and her blood pressure was out of control. Her troponin kept increasing and had inflammation around her heart. Her symptoms of anaphylactic reaction went away that same day, 22Jan2021, at the vaccination from her anaphylactic reaction. Patient was discharged and released from the cardiac unit on that Saturday (23Jan2021 ) around 7:30pm. No one could tell her anything about this since she was still having lingering effects and was getting ready to locate a cardiologist and still has tightness in the chest. She mentioned the dizziness did not allow her to go to work. She experiences it on and off, not consistent but less severe than initially. She still had lingering dizziness and she had to drive for a majority of her day and that was concerning. She said that on the left side she will get a tightening in her chest. She said that no one knows what this means moving forward. Patient was concerned about the severity of the reaction and was still not back to normal. She had never had a reaction to any vaccine or shot before and has been in the military. She needed help, direction since she was still not at the full potential to work. She was still fatigued and has tightness of her chest and those are concerns for her. Patient mentioned a part of the symptoms she also had were lightheadedness and dizziness and that started after the vaccine and it's not as severe, but she still had it. On left side of her temple toward the crown of her head she had pressure on the left side of the body and that was the same side where she received the injection, on that left side. Outcome of anaphylactic reaction was resolved with sequel on 22Jan2021. Outcome of heart enzymes elevated was resolved on 23Jan2021. Outcome of blood pressure was out of control was resolved with sequel on 23Jan2021. Outcome of lingering dizziness was resolving. Outcome of left side of temple toward the crown of head she had pressure on the left side of the body, lightheadedness was not resolved. Outcome of tightness in the chest and fatigue was not resolved. Outcome of inflammation around heart and troponin kept increasing was resolved with sequel on an unknown date. Outcome of the other event was unknown.
53 2021-02-22 pain in extremity Aside from the usual chills arm pain aches and general malaise for 5 days , I?ve had more frequent ... Read more
Aside from the usual chills arm pain aches and general malaise for 5 days , I?ve had more frequent and looser stools and stomach cramping since the day of the vaccine .
53 2021-02-23 weakness having flue symptoms, no energy began on 2/14/2021 consistant
53 2021-02-23 flushing Patient complained of flushing, tingling tongue, dry mouth.
53 2021-02-23 migraine I had pain at the injection site which started about 2 hours after the shot. (I had had this after ... Read more
I had pain at the injection site which started about 2 hours after the shot. (I had had this after the first shot as well, but it happened faster this time and was a little more severe). About 12 hours after the injection, I started to feel feverish, and went to bed - fever seemed to spike during hours 12-16 post-injection. (I did not take my temperature because I was in bed and really not feeling well.) I had chills, sweating, muscle aches, restless sleep, and a headache. I remained feverish most of the next day and had a migraine level headache the entire day; temperature reads were in the 100-101 degree range for the entire next day, until about 10pm (a full 24 hours after the onset of symptoms, 36 hours from injection.), when it went down to 99 degrees, and then finally seemed to subside.
53 2021-02-24 pain in extremity Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, ch... Read more
Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, chills, sleepiness, severe pain in the arm of the vaccine, thirst, constant desire to urinate.
53 2021-02-24 tingling Tingling in L arm, lightheaded, dizziness, evaluated by EMS-cleared
53 2021-02-24 tremor, tingling, feeling hot, burning sensation Felt hot, burning sensation across chest, palpitations, dizziness, having sensation of everything... Read more
Felt hot, burning sensation across chest, palpitations, dizziness, having sensation of everything smelling sweet, tingling in hands and feet, hands shaking, slight nausea. Evaluated by EMS. Had not eaten given water and tea. Ate protein bar. Feeling better, symptoms resolved. Discharged home at 9:45am.
53 2021-02-25 weakness Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; head... Read more
Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; headache; nausea; lack of appetite and energy; lack of appetite and energy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 10Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, High blood pressure, arthritis, obese, anxiety, depression. Concomitant medication included lamotrigine, duloxetine hydrochloride (CYMBALTA), ropinirole hydrochloride (REQUIP) and unspecified blood pressure meds. On 12Feb2021, the patient experienced raised swollen lump at injection site, muscle and joint aches, fatigue, headache and nausea, lack of appetite and energy. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has been tested for COVID-19, nasal swab on 04Dec2020: negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
53 2021-02-25 numbness Arm went numb within first hour after dose, continued up through neck. Next morning I felt flu-like ... Read more
Arm went numb within first hour after dose, continued up through neck. Next morning I felt flu-like symptoms, Achy muscles and joints, fever that varies between 100° and 101.6°, bad headache, severe fatigue.
53 2021-02-26 weakness These symptoms were from the 2nd dose. Tenderness at injection site, fever, body aches, vomiting, se... Read more
These symptoms were from the 2nd dose. Tenderness at injection site, fever, body aches, vomiting, severe headache, fatigue, weakness - 3 days duration
53 2021-02-26 facial paralysis, numbness, face paralysis Numbing on left side of the face, unable to close left eye all the way no control on left side of th... Read more
Numbing on left side of the face, unable to close left eye all the way no control on left side of the lips; sharp pain on neck and jaw
53 2021-02-26 numbness Numbness of the face. Numbness started to subside by 2:30 pm.
53 2021-02-26 nerve pain, pain in extremity Painful red blistered toes muscle aches and fatigue developed approximately 18 days after vaccine ac... Read more
Painful red blistered toes muscle aches and fatigue developed approximately 18 days after vaccine accompanied by painful sensory neuropathy. Covid test on 2/12/21 negative. Pain and rash persisted and worsened. I saw my primary doctor on 2/19/21 because my rheumatologist had left her practice. He checked my circulation and prescribed prednisone course to be taken if problem worsened. I waited another week because I am reluctant to take prednisone and was then advised by my friend who is a rheumatologist that I should go ahead with the steroid. This rash resembled the "Covid toes " phenomenon that has been reported in response to the actual Covid 19 viral infection and the neuropathic pain in my feet was very uncomfortable. I started prednisone course 40 mg QD on 2/26/21 with some improvement so far after one day.
53 2021-02-26 pain in extremity Nausea, dizziness, aches, fatigue
53 2021-02-27 flushing, tingling, numbness Within 2 minutes of receiving the injection, I experienced the following symptoms simultaneously: sk... Read more
Within 2 minutes of receiving the injection, I experienced the following symptoms simultaneously: skin flushed/got hot, hands got numb and tingly, back of and sides of my tongue got thick- felt like it was swelling, got more difficult to breathe, heartbeat started racing, felt light-headed. I sat up in the edge of my seat and almost called for help, however the symptoms subsided within 2-3 minutes and then I was fine. Had a lingering, very minor headache and no other symptoms. I didn't tell anybody and came home and took 1 benadryl just to be safe.
53 2021-02-28 inability to speak Diarrhea, nausea, headache, chills, fever,--within first 24 hours after receiving the second dose. N... Read more
Diarrhea, nausea, headache, chills, fever,--within first 24 hours after receiving the second dose. Nausea and fatigue persisted, along with the loss of appetite (as of this date, still no appetite...only being able to handle orange juice and saltine crackers); emotions are still a wreck; concentration level is still small; multi tasking is not doable; seem to lose words along the way in conversation.
53 2021-02-28 weakness I started with fatigue the afternoon of my 2nd vaccine. Slept from 3:40 that afternoon until the fol... Read more
I started with fatigue the afternoon of my 2nd vaccine. Slept from 3:40 that afternoon until the following morning at 5am. Body aches/mild. Worked the next day but had to leave an hour early due to fatigue and body pain. That evening developed nausea. (2-26). The 27th I had a terrible headache upon waking with increased nausea. Started vomiting around 10am. Unable to take in any liquid until that evening late. The 28th mild headache, more of a heavy headed feeling. Today, March 1st, nausea without vomiting thus far, weak & drained feeling.
53 2021-02-28 numbness Lost 100% of vision in left eye and 50% of vision in right eye; Numbness of face and neck; Numbness ... Read more
Lost 100% of vision in left eye and 50% of vision in right eye; Numbness of face and neck; Numbness of face and neck; Swelling of face and neck; Swelling of face and neck; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot number EN6201), via an unspecified route of administration in right arm, on 10Feb2021 at 15:45, at single dose, for COVID-19 immunisation. Medical history included blood cholesterol increased. Patient did not have known allergies, did not have COVID-19 prior to vaccination and was not pregnant at time of events or vaccination. There were no concomitant medications. Patient did not receive other different vaccines in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot# EL3244), in arm left, on 20Jan2021 at 15:45, for COVID-19 immunisation. The patient experienced lost 100% of vision in left eye and 50% of vision in right eye on 10Feb2021 at 17:30 with outcome of recovered on 11Feb2021 at 07:30 (after 14 hours), numbness of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours), swelling of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours). Patient did not tested positive for COVID-19 after vaccination. No follow-up attempts are possible. No further information is expected.
53 2021-02-28 pain in extremity Muscular soreness in upper arm traveling up to shoulder and back of neck. No swelling or rash but i... Read more
Muscular soreness in upper arm traveling up to shoulder and back of neck. No swelling or rash but it's too the point where I can't lift my arm.
53 2021-02-28 pain in extremity Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer ... Read more
Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), intramuscular on the left arm, on 08Jan2021 16:29, at single dose, for Prevention/COVID-19 immunization, at a public health department. There were no medical history and concomitant medications. The patient did not receive other vaccinations within 4 weeks. On 09Jan2021 at 08:00, the patient experienced left arm soreness. On 27Jan2021 at 07:00, the patient felt dizzy. Shortly after, at 07:15, the nausea started. The patient wanted to know if these could be side effects and would it still be okay to get the scheduled second dose on 29Jan2021. The patient also asked if she can get the second dose if she has a fever on the day she is supposed to get the second dose. The events did not require emergency room or physician's office visits. The patient was recovering from the events. The reporter assessed the events as non-serious.
53 2021-02-28 tingling The patient reported tingling in left side of face from left ear to chin area after first dose of va... Read more
The patient reported tingling in left side of face from left ear to chin area after first dose of vaccine. (The lot number for Dose #1 is not readily available. The Lot # for dose number 2 was provided in this report.) She stated that after he left the gem to get in his car he chose to follow up on the tingling at home. The tingling in the jaw near the ear reduced after several days but remained in the left lower jaw area and has continued until now. The clinical nurse practitioner in the 2nd dose observation area asked patient to remove mask and there was no obvious paralysis in the left jaw area and no signs or symptoms consistent with typical Bell's Palsy presentation. 1st dose was in the left arm, 2nd dose was in the right arm.
53 2021-02-28 throat numbness, tingling, numbness Pt received first dose of Pfizer vaccine and was sitting in the observation area for about 5 minutes... Read more
Pt received first dose of Pfizer vaccine and was sitting in the observation area for about 5 minutes when she alerted staff that she was feeling numbness and tingling to lips that was moving up face and down to throat. Pt stated that she also had slight difficulty breathing which was relived when she took off her mask. She stated that she has allergies to papaya and cantaloupe and this reaction was similar. Pt was given 50mg Benadryl and stated that she was feeling much better about 15 minutes later. Vital signs WNL. Pt d/c home with instructions on when to seek medical care.
53 2021-03-01 facial paralysis, tingling, bell's palsy tingling above lip on Sunday, went into left cheek, tightness in eye muscle, lymph node pain, lt-hea... Read more
tingling above lip on Sunday, went into left cheek, tightness in eye muscle, lymph node pain, lt-headache in occipital bone -2/26 went to hospital, paralyzed in left side of face, bells palsy
53 2021-03-01 muscle spasms I began menstruating after no menstruation cycle?s for one year. I also experience headache and cra... Read more
I began menstruating after no menstruation cycle?s for one year. I also experience headache and cramping.
53 2021-03-01 tingling Mild tingling sensation over the arm and redness over left hand right after receiving her second dos... Read more
Mild tingling sensation over the arm and redness over left hand right after receiving her second dose of Covid 19 vaccine. Adverse reaction occurred during observation. Benadryl 2 tabs (25 mg each) oral administered. Patient observed for 45 mins. Symptoms cleared. Patient left home verbalizing feeling safe and cleared of any symptoms.
53 2021-03-02 grand mal seizure Patient experienced tonic clonic seizure within a few minutes of receiving first dose. I was informe... Read more
Patient experienced tonic clonic seizure within a few minutes of receiving first dose. I was informed at upon arriving at the scene that she had history of seizure but I cannot validate this information. She was evaluated by the emergency department immediately.
53 2021-03-03 tingling, pain in extremity, muscle spasms, numbness, weakness Cannot determine if last digit is a U or J. 10 days post injection acute onset of pinched nerve i... Read more
Cannot determine if last digit is a U or J. 10 days post injection acute onset of pinched nerve in lower neck/ upper back where left arm connects. Numbness/weakness in left arm and pain upon lifting arms above shoulders. Either side but significantly worse on left side. Limited mobility to move neck and head without pain unless medicated. Muscle spasms left of spine in upper back/neck and tingling down left arm. Severe pinched nerve pain that got progressively worse from onset.
53 2021-03-03 tremor, feeling hot, migraine March 2, 2021 1. At vaccination site, severe itchiness, dizzy, felt really hot, sweaty. Nurse too... Read more
March 2, 2021 1. At vaccination site, severe itchiness, dizzy, felt really hot, sweaty. Nurse took blood pressure 120 over 80. Stayed for 1/2 hour (9:10-9:41 a.m.). 2. Drove to work . All symptoms persisted, entire body turned bright red (like sunburn), extreme shaking. Checked in with school MA (nurse) . Blood pressure 140 over 80. Temperature 100. Extreme agitation and heightened senses. 3. sent me to Urgent Care seen at 11:35 a.m.. Same symptoms persisted. Blood pressure 143/94. Temperature 98.8. Was prescribed 2 Benedryl now, 1 every 4-6 hours as long as have itching. 2 at night for next 7 days. Prescribed Prednisone (10 mg) 4 one day, 4 next day - decrease dosage for 8 days. 4. Took prednisone- heightened senses, agitation increased. Migraine. Outer body exhausted, inner pure adreneline that would not decrease. March 3, 2021 1. Most symptoms lessened. Went to work . Checked in with MA (nurse) and told her that I wanted to stop the prednisone. She recommended that I take the dose. Took 4 tablets (10 mg) at 9:40 a.m. Heightened senses (light, sound, touch, taste), agitation, shakiness. brought me to in . Doctor told me to stop the prednisone as I have a history of anxiety. Exhaustion, heightened senses, agitation remained the rest of the day. March 4, 2021 1. Lessened symptoms. Four 20-minute recurrence episodes between the hours of 9 a.m. and 5 p.m.
53 2021-03-04 burning sensation, pain in extremity Within a few minutes of getting the injection my face began tingling. A few minutes after that the ... Read more
Within a few minutes of getting the injection my face began tingling. A few minutes after that the tingling turned into a burning feeling. My cheeks were slightly flushed but felt like I had a bad sunburn. At the same time my throat felt thick. I could talk and breathe but it definitely felt like it had swelled inside my throat. I also felt shaky. My hands were not shaky but I felt shaky on the inside. I didn't report this to the people working the vaccine clinic (but in retrospect I should have) The thick throat feeling resolved within one hour and the face burning feeling was gone by the next morning. Then I just had the typical sore arm, a few body aches and nothing else. Note: never a vaccine reaction but I had an anaphylactic reaction requiring treatment when receiving a 2nd dose of chemotherapy
53 2021-03-06 pain in extremity Woke in middle of night with pain down left arm clear down to my fingers. Could not lay on left side... Read more
Woke in middle of night with pain down left arm clear down to my fingers. Could not lay on left side due pain. All day on the day after vaccination had nausea, fatigue, tiredness and aches. No fever. Symptoms went away on the following day-02/22/2021
53 2021-03-06 tingling, numbness Within 10 minutes my face and head was tingling and went numb. Eyes felt swollen/numb. This lasted ... Read more
Within 10 minutes my face and head was tingling and went numb. Eyes felt swollen/numb. This lasted for 4 hours. Both hands also were numb even longer. EMT's on site checked my vital signs. My blood pressure and oxygen were OK so they said I could drive home when I felt ready.
53 2021-03-06 seizure Patient had seizure 5 min after receiving shot. Lasted 2-3 minutes, given versed IM and started to ... Read more
Patient had seizure 5 min after receiving shot. Lasted 2-3 minutes, given versed IM and started to improve. Monitored through post ictal phase - blood glucose was 186, BP 176/90. Was able to walk after about 20 minutes but taken by ambulance to hospital for further monitoring.
53 2021-03-07 tingling, hot flush I took one Aleve for my arm Pain near the injection site. Then I got a Rash and itch that traveled d... Read more
I took one Aleve for my arm Pain near the injection site. Then I got a Rash and itch that traveled down my left side, my throat started to feel funny so I took a Benedryl. Then my cheeks felt like they were hot and tingly.
53 2021-03-08 tingling, numbness, flushing Vaccine was admin. at 1310 via LPN. Pt. then waited until 1325 in the clinic waiting room per Protoc... Read more
Vaccine was admin. at 1310 via LPN. Pt. then waited until 1325 in the clinic waiting room per Protocol for observation of serious adverse reaction to vaccine. At 1325, pt. reported feeling well and left the clinic. After returning to her private vehicle from vaccine clinic, pt. states that she noticed her face was flushed and her tongue "felt funny." At 1337, the pt. returned to the front entrance of hospital reporting that she thought she may be having a reaction to the vaccine. Pt. was immediately taken to the ED for evaluation. According to the patient, she was given 50 mg IV Benadryl and observed for a short time. Her symptoms of tongue swelling, itchiness with no hives, mild numbness/tingling in extremities bilat., tingling at top of head all resolved. Pt. was then discharged to home with a prescription for Prednisone and instructed to return to ED with any new/worsening symptoms. Pt. also instructed to f/u with PCP regarding advice for admin. regarding second dose of Covid-19 vaccine.
53 2021-03-08 tremor, burning sensation, feeling hot FEW MINUTES AFTER VACCINE PATIENT STATED SHE FELT HOT , THAT THE ARMS HAS A BURNING SENSATION, SHE W... Read more
FEW MINUTES AFTER VACCINE PATIENT STATED SHE FELT HOT , THAT THE ARMS HAS A BURNING SENSATION, SHE WAS ALSO COLD AND SHAKING. BLOOD PRESSURE HIGH ( 911 WAS CALLED PT REFUSED TO GO TO THE HOSPITAL). WE KEPT HER IN OBSERVATION WITH EMS ONSITE, AFTER MORE THAN ONE HOUR SHE COMPLAINED OF CHEST PAIN, TRANSFERRED TO ER VIA AMBULANCE.
53 2021-03-09 pain in extremity Starting shortly after the injection she had severe left arm pain. Symptoms have varied over the las... Read more
Starting shortly after the injection she had severe left arm pain. Symptoms have varied over the last 2 months, but she has noticed decreased ROM in the shoulder, pain sleeping on the left side at night, a lump at the site of the injection and ongoing pain. She has taken Aleve and ibuprofen intermittently with some relief.
53 2021-03-09 pain in extremity Soreness in arm, headache, fogginess
53 2021-03-10 bell's palsy, facial paralysis Patient reports that about 3-4 days after receiving the first dose, she started experiencing difficu... Read more
Patient reports that about 3-4 days after receiving the first dose, she started experiencing difficulty in chewing and drooling out of the left side of her face. She then noticed a mild facial droop. On March 7th, 2021 she was evaluated in the Emergency room and diagnosed with Bells' Palsy. Shewas discharged home the same day and was prescribed Valtrex and Prednisone. On March 9th, 2021 she consulted with a neurologist. She came in for consultation with us (infectious disease) on March 10th, 2021.
53 2021-03-10 flushing feels flushed, lips tingling, reports feeling throat closing. Evaluated by EMS-Cleared
53 2021-03-10 migraine and treatment, if any: Headache Narrative: I have flu like symptoms and migraine possibly re... Read more
and treatment, if any: Headache Narrative: I have flu like symptoms and migraine possibly reaction from the vaccine yesterday. Adding staff for protocol.
53 2021-03-10 pain in extremity, weakness This was my second vaccine. The day after the shot I had the typical headache, sore arm, low energy.... Read more
This was my second vaccine. The day after the shot I had the typical headache, sore arm, low energy. Then at this time mentioned I woke up with my head spinning and it made me nauseous. It is now 4 days later and I am still dizzy if my head isn't pushed against a pillow or it standing. I went to doctor, he called it vertigo, I went to physical therapist to see if he could fix it, he said my crystals were not out of place to be fixed.
53 2021-03-10 pain in extremity pain and swelling in underarm area of same arm where received vaccination. This started approximatel... Read more
pain and swelling in underarm area of same arm where received vaccination. This started approximately 36 hours after vaccination. Has continued for more than 24 hours. Still swollen and sore at this time. Injection site is also still sore, but not severe, and no swelling or redness at the injection site.
53 2021-03-10 tingling SOB, sensation of throat closing, tingling in the arms, evaluated by EMS, transported to nearest ER
53 2021-03-11 feeling cold, weakness Pain at the injection site?pain and weakness all over?feel the cold
53 2021-03-11 flushing Flushed face, neck and itchy face(8 hours) started 30min. after vaccination Fever(48hours) starting ... Read more
Flushed face, neck and itchy face(8 hours) started 30min. after vaccination Fever(48hours) starting 03/07/2021 Body aches(48 hours) Chills(48 hours) starting 03/07/2021 Severe Headache(36 hours) started 30 min. after vaccination.
53 2021-03-11 numbness Approximately 5 minutes post vaccination patient had numbness from shoulder to hand. Numbness impro... Read more
Approximately 5 minutes post vaccination patient had numbness from shoulder to hand. Numbness improved approximately 15 minutes post vaccination.
53 2021-03-11 seizure Itching all over, while being evaluated by EMS, patient began seizing-transported to nearest ER.
53 2021-03-12 numbness and pain in extremities, tingling I HAVE HEADACHES AND NAUSEA THAT WAX AND WANE SINCE I RECEIVED MY SECOND SHOT ON JAN 31ST. THE HEADA... Read more
I HAVE HEADACHES AND NAUSEA THAT WAX AND WANE SINCE I RECEIVED MY SECOND SHOT ON JAN 31ST. THE HEADACHES ARE PRESSURE HEADACHES THAT ARE MOSTLY ON THE TOP OF MY HEAD BUT CAN MOVE AROUND MY HEAD AND FACE. THEY RANGE IN SEVERITY FROM SEVERE AND INTERFERE WITH MY ABILITY TO THINK TO MILD AND ABLE TO FUNCTION BUT THEY ARE ALWAYS PRESENT. I WAKE UP WITH THE HEADACHES AND NAUSEA. MY NEUROPAHTY ON MY LEFT ARM,WHICH RECEIVED THE SHOT, HAS GOTTEN WORSE WITH INCREASED TINGLING AND A FEELING LIKE A BAND IS SQUEEZING AROUND THE TOP PART OF MY ARM.
53 2021-03-12 pain in extremity Mouth sores - three of them on tip of tongue I took a pic if you want it. They don?t hurt much just ... Read more
Mouth sores - three of them on tip of tongue I took a pic if you want it. They don?t hurt much just wanted to let you know because I did not see this listed. Still there as of today 3-13-2021. Also sore arm and some tiredness
53 2021-03-12 tenderness Woke up the morning at 7:30 after the 2nd vaccine yester at 1:30 and had a deep bruise on left eye ... Read more
Woke up the morning at 7:30 after the 2nd vaccine yester at 1:30 and had a deep bruise on left eye lid only. No puffiness, slightly sore to the touch, eye is a bit watery, vision is currently unaffected.
53 2021-03-13 feeling cold I woke up at one with a stomachache and slight headache. My 7, i experienced aches in joints and bo... Read more
I woke up at one with a stomachache and slight headache. My 7, i experienced aches in joints and body. I did experience chilling off and on and no appetite. The next day, I experienced diarrhea and stomach ache. No appetite. On Saturday, I was feeling better. By mid morning, my stomach was hurting, and I was cold. Still not much of an appetite. On Sunday,I woke up feeling good. By 3, I was experiencing extreme exhaustion, chilling, and difficulty breathing.
53 2021-03-13 feeling hot Severe chills from 10am-3pm on 3/13/21 along with fatigue. At 4pm I got extremely hot and started w... Read more
Severe chills from 10am-3pm on 3/13/21 along with fatigue. At 4pm I got extremely hot and started with back and chest pain along with not being able to get a good breath in.
53 2021-03-13 hot flush It was painful the injection at all point but I didn?t complaint as I was able to support the paint ... Read more
It was painful the injection at all point but I didn?t complaint as I was able to support the paint in my 15 min wait my pain in the arm was what I consider strong but still able to support, 25 min after the injection I started hot flash and redness in face and neck, The reaction was only 5% of the reaction I experimented with Chemo so I knew I was ok and I did not have to run to the medical center again. In the hour after the injection the paint in the arm intensified and it was from the base of the neck to the lower back, during the weekend I lost some moved of my arm and I took Tylenol every 8 hours as per the post vaccine indicator, and slept a lot as I was too tired and having a little of running nose, by the Monday (72 hrs) w Most of the hot flashes and running nose stopped and the pain was under my pain threshold and I managed to reduce Tylenol only to one before bed time, however last night pain intensity and arm movement reduce again. i will be calling my primary doctor on Monday to review
53 2021-03-14 weakness, burning sensation Headache, Myalgia, UrticariaPruritus, NauseaVomiting, Tachycardia, Reports had R knee pain (prior ... Read more
Headache, Myalgia, UrticariaPruritus, NauseaVomiting, Tachycardia, Reports had R knee pain (prior injury there) and took tylenol, naproxen and tramadol for symptoms which were intermittent for the next 10 days. Narrative: Employee directed to go to ED and declined. Employee is a physician. Employee took 2nd Pfizer Vaccine, EL1042 on 1/13/2021 and experienced L shoulder injection site pain, headache, body aches. Fever up to 101F. Tx with tylenol, Reports in bed all day. Missed work on 1/14/2021 and 1/15/2021. 1/15/2021 got up and severe burning all over body. Smell decreased and change in taste. Reports increased teeth sensitivity to cold, citrus tastes. Feeling more weak and fatigue. Neurologist diagnosed with Small fiber neuropathy R/ T Covid vaccine administration on 3/3/2021.
53 2021-03-14 migraine Started with migraine, fever, chills after three hours of injection, night two same, night three sam... Read more
Started with migraine, fever, chills after three hours of injection, night two same, night three same, four night histamine levels were high and developed hives on back and chest area, fever, five night same, sixth night shortness of breath, fever, seventh night shortness breath, fever. Night eight same, tenth day went to urgent care x-ray lung had fluid and pneumonia . 12 day blood pressure was 80/50 and admitted in ER.
53 2021-03-14 pain in extremity, muscle spasms Immediately after vaccine rec'd last Thursday, I immediately after shot I began to feel weird like s... Read more
Immediately after vaccine rec'd last Thursday, I immediately after shot I began to feel weird like something in my throat and it's still there, my arm was hurting, that night I was able to sleep, Friday it started getting more sore, Saturday I noticed I could not sit because my butt cheeks were hurting, then I started feeling leg and hand cramps on my left side, Then Sunday my arm, leg, back, spinal cord everything was hurting and I was extremely thirsty and I couldn't lay down, sit or even walk. I have not been feeling good at all. Also, I have lupus
53 2021-03-14 pain in extremity PT CALLED ON WEDNESDAY MARCH 10TH WITH A LOT OF SORENESS IN HER ARM AND THE PHARMACIST TOLD HER TO T... Read more
PT CALLED ON WEDNESDAY MARCH 10TH WITH A LOT OF SORENESS IN HER ARM AND THE PHARMACIST TOLD HER TO TAKE TYLENOL OR IBUPROFEN TO HELP WITH THE PAIN. SHE CAME TO THE PHARMACY TODAY MARCH 15TH WITH THE SAME COMPLAINT AND SAID IT HAS GOTTEN WORSE. I TOLD HER TO GO TO URGENT CARE IF IT REMAINS THESAME OR GETS WORSE.
53 2021-03-14 pain in extremity I received the 1st vaccine on March 4th. Only had a sore arm. Then on March 10th I woke up before 2:... Read more
I received the 1st vaccine on March 4th. Only had a sore arm. Then on March 10th I woke up before 2:00 that morning itching all over. At 6:30 am I was covered in painful rash from behind my knees to my shoulders. It itches and hurts. I went to immediate care at which time they gave me a steroid shot, antihistamine tablets and a cream. Today it got so painful I went back to immediate care and was given a shot of epinephrine and given an epipen. The rash is raised and deep red. Very itchy and painful. It is now on my hands as well and they are stiff and swollen. Both doctors that I seen suggested going to regular physician before taking second dose of vaccine
53 2021-03-14 pain in extremity Sore arm immediately upon injection. Soreness travelled to fingertips within 4 hours. No treatment ... Read more
Sore arm immediately upon injection. Soreness travelled to fingertips within 4 hours. No treatment required. Headache within 2 hours. Very distracting although not severe. Prevented sleeping. Took 1x advil 200mg. Resolved. Foggy head within 4 hours. Trouble focusing eyes and thoughts while having a conversation with neighbor. Resolved at 48 hours. Tiredness within 6 hours. Resolved at 54 hours. Chills but no fever starting at ~27 hours from shot and lasting 4 hours. Resolved.
53 2021-03-15 weakness, pain in extremity, nerve pain 3/9/21: 1:05pm: Nerve-like pain immediately neck to fingertip. 5pm--extreme arm soreness for 3 days;... Read more
3/9/21: 1:05pm: Nerve-like pain immediately neck to fingertip. 5pm--extreme arm soreness for 3 days; less extreme soreness still present at 7 days. 3/10/21: 2am: fever, chills, body aches, headache, fatigue, weakness for 48 hours. 3/13/21: golf ball sized redness at site of shot, intermittent itchiness/soreness
53 2021-03-15 weakness Severe nausea after first shot 3 days after 1st Vaccination ~ dizziness, weakness, exhaustion, heada... Read more
Severe nausea after first shot 3 days after 1st Vaccination ~ dizziness, weakness, exhaustion, headaches, using albuterol inhaler in the morning for shortness of breath, bad taste in the mouth and stomach described as the taste of burnt rubber and smell and taste of ignited /lit matches, excessive thirst and dry mouth that has prevented me doing normal activities ~ general malaise and feeling unwell
53 2021-03-15 burning sensation Burning in the arm of injection. Slight red rash, itchy. Tingly lips, fever, headache. Went away in ... Read more
Burning in the arm of injection. Slight red rash, itchy. Tingly lips, fever, headache. Went away in two days
53 2021-03-15 electric shock sensation, slurring 2 hours after vaccine -fever, chills muscle aches adn stiffness. treated with ibuprofen and cold p... Read more
2 hours after vaccine -fever, chills muscle aches adn stiffness. treated with ibuprofen and cold pack. Next day - difficulty swallowing, chewing and speaking, alot of mucus in throat, difficulty breathing . Was lethargic, dehydrated. Used inhalers , benedryl, musinex, Still have chills and fever, and headaches. and aches. Difficulty eating and drinking. Was gagging and dry heaves. Called neurologist and family doctor and suggested go to ER. (did not go because of fear of getting covid) Too fatigued and week to walk. No Balance. Had electrical shocks up and down body. Immobile. Still experiencing immobility a week later
53 2021-03-15 numbness, tingling Within 30 minutes of vaccine entire left side had numbness and tingling from left toes to left eye w... Read more
Within 30 minutes of vaccine entire left side had numbness and tingling from left toes to left eye with radiating pain in head and swelling of neck and throat. Numbness subsided within 24 hours followed by pain and sensitivities on entire left side for the next 24 hours. Swelling in throat continued for the next 24 hours following vaccine peaking the next day 36 hours after vaccine. Significant trouble swallowing liquids including salvia. Choking on solid foods the day following vaccine. Lips tingling continued for 48 hours after vaccine and subsided at end second day 3/12. Throat and esophagus swelling continues to this day - 6 days after vaccine with only slight improvement in swelling. Swallowing is still difficult as of 6 days following 1st vaccine. Spoke with EMT at vaccine site who recommended Benadryl. Benadryl started within 1.5 hours of vaccine administration. Contacted allergist who recommended 2-3 x dose of antihistamines for swelling. A dose of 3x was done for 4 days and decreased to 2x dose of antihistamines on Monday and continue at that level at time of report today.
53 2021-03-15 night sweats Severe night sweats; body aches; low grade temps continuing growth off and in; This is a spontaneous... Read more
Severe night sweats; body aches; low grade temps continuing growth off and in; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231), via an unspecified route of administration (left deltoid) on 09Jan2021 at single dose, for COVID-19 immunization. Medical history included celiacs, hypertension (HTN), thyroid disease, gastrooesophageal reflux disease (GERD), migraines, allergies: celiacs (gluten), and allergies: culturelle. Concomitant medications included levothyroxine and prednisone which was stopped 4 days prior. The patient previously took dilaudid and experienced allergies and received first dose of bnt162b2 for COVID-19 immunization on 18Dec2020, 13:15, left arm (lot ELO140). On 11Jan2021, the patient experienced severe night sweats, body aches and low grade temps continuing growth off and in since second vaccine. Patient reported to have missed work. This has been going on for 3.5 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab: negative on 27Jan2021. Outcome of events was not recovered.
53 2021-03-16 limb paralysis, mild one side paralysis 12 hours after receiving a shot I woke up from a sleep and when I went to walk her right leg collaps... Read more
12 hours after receiving a shot I woke up from a sleep and when I went to walk her right leg collapsed under her. She hit her head at that point. Her leg remained unable to bear weight and Monday morning we went to the emergency room where they diagnosed her with a stroke. Her right leg is paralyzed and her right side weak.
53 2021-03-16 pain in extremity Arm pain within 2 hours, extreme fatigue, malaise, vivid dreams, headache lasting 10 hours
53 2021-03-16 pain in extremity As soon as I got to my car in the parking garage my left knee started hurting, like aching. Went to... Read more
As soon as I got to my car in the parking garage my left knee started hurting, like aching. Went to the store when I got home my left ankle and the top of my left foot started to hurt. Fell asleep took a nap and woke up and my whole body hurt left arm was really hurting. Woke up Sunday morning and whole body hurt X10! Back, knees, hands, wrists, fingers, shoulders, shoulder blades, neck, left arm. Woke up Monday and could hardly move right arm and this is Wednesday and it still hurts, hands and wrists still ache, not as bad but still do. It seems like it really got to my joints, which I already have issues with but since the shot the issues have increased X10.
53 2021-03-17 discomfort Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chil... Read more
Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chills; funny taste; dizziness; itchy feelings; tired; discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202, expiry date not reported), via an unspecified route of administration administered in arm right on 26Feb2021 14:00 as single dose for covid-19 immunisation. Medical history included hypertension and known allergies: arrhythmia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced hallucinating, lot of pain all over her body, chills, funny taste, discomfort, dizziness and feel like her body is having a allergic reaction and itchy feelings and tired on 27Feb2021 01:00. The patient did not recover from the events.
53 2021-03-17 pain in extremity, numbness and pain in extremities neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM... Read more
neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM PAIN AND JOINTS/PAIN PROGRESSING TO CONSTANT SEVERE PAIN AND HAS MOVED INTO UPPER ARMS WITH PAIN WORSENING DAILY; BILATERAL LOWER ARM PAIN AND JOINTS; SWOLLEN LYMPH NODES IN ELBOWS; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284, expiration date: not reported) intramuscular in the arm left on 01Feb2021 08:00 at single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and lamotrigine (LAMICTAL). The patient previously took codeine and experienced allergic reaction to drug; naproxen and sulfur and experienced drug allergy. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the hospital. On 02Feb2021 06:00, the patient experienced neuropathy in left foot, headaches/intermittent headaches, nausea, muscle aches, bilateral lower arm pain and joints, swollen lymph nodes in elbows, pain progressing to constant severe pain and has moved into upper arms with pain worsening daily. No treatment received for the adverse event. Outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event neuropathy peripheral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
53 2021-03-18 weakness received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minute... Read more
received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minutes. Symptoms increased and continued through out the night, childs and sweats , overall feeling of weakness. Mentally slow processing, feeling foggy. Symptoms Cleared on Monday evening around 9pm. New symptoms on March 19th swollen glands roof of my mouth, neck, underarms. Painful, brain fog, exhaustion, chills and sweats, stuffy nose, headache.
53 2021-03-18 pain in extremity On the night of the 15th when i received the vaccine my arm was sore and i was very tired. I woke up... Read more
On the night of the 15th when i received the vaccine my arm was sore and i was very tired. I woke up next day after a great sleep and arm was just a little sore but I was totally exhausted and napped through the day and went to sleep that night. Wednesday the 17th of march I woke up at 4:30 in morning with a screaming headache and my neck and shoulder muscles were extremely tight. I felt like my head was going to explode! I am not used to headaches but this one hurt pretty bad. I took Tylenol and used ice packs on head and neck and back shoulders. I used Electronic Muscle Stimulator Pads for 12 minutes on middle shoulder back area. That evening I was feeling a little better with small headache but when i was rubbing
53 2021-03-19 muscle twitching Continual involuntary twitching of chin area & one leg; never twitched like this before
53 2021-03-19 restless legs syndrome For several days, immediately following each dose, I had terrible restless legs/body that lasted 7 d... Read more
For several days, immediately following each dose, I had terrible restless legs/body that lasted 7 days after the first dose and about 3 days after the second dose. Then it went away. March 3, 2021, I developed painful, raised, erythematous lesions that developed large blisters on top. March 18, 2021 and March 19, 2021 it happened again.
53 2021-03-21 weakness Lightheaded, dizzy, weak, headache -10:00am Left work by noon. Feeling same
53 2021-03-21 weakness Patient was at the vaccine site. Patient was in waiting area after receiving vaccine, and reported t... Read more
Patient was at the vaccine site. Patient was in waiting area after receiving vaccine, and reported to me, she felt a little weak because she had not eaten yet that day. Patient then reported she felt like she was going to pass out and grabbed on to my legs. I held her with my hand on her back, and I waved and shouted for help. The Paramedics on site came to assess patient, and took over caring for the patient. The patient never lost consciousness, she was fed a granola bar, and was able to leave on her own.
53 2021-03-21 bell's palsy Transient face swelling, right eye dryness, cluster headaches since 03/05/21. Bells palsy symptoms ... Read more
Transient face swelling, right eye dryness, cluster headaches since 03/05/21. Bells palsy symptoms right side of face since 03/07/21. Swelling is transient symptom. Cluster headaches are transient symptoms. Bells palsy symptoms have not resolved. Treatment from PCP is steroid prescription started 03/20/21.
53 2021-03-21 feeling hot The patient had her covid 19 vaccine. Shortly after that she got hot in the face, fuzzy headed, and ... Read more
The patient had her covid 19 vaccine. Shortly after that she got hot in the face, fuzzy headed, and nauseated. Her pulse ox was 99 percent. Pulse 73. BP 134/93. Once we laid her down and got her some juice and crackers, her symptoms quickly resolved. Her current meds are lisinopril 20mg, synthroid, and isosorbide.
53 2021-03-21 numbness Vaccinated 1 min. c/o dizziness, hn R side @1340 BP 145/80, P 80, O2 100%, BS 107. 1403 hn now backh... Read more
Vaccinated 1 min. c/o dizziness, hn R side @1340 BP 145/80, P 80, O2 100%, BS 107. 1403 hn now backhead. 1405 BP 145/74, BS 107. denies need for transport. Advised to call 911 if conditions change.
53 2021-03-21 migraine Migrain on day 1 &2 after vaccine; Lightheaded and slight dizziness on day 1; Drowsiness on Day 1 af... Read more
Migrain on day 1 &2 after vaccine; Lightheaded and slight dizziness on day 1; Drowsiness on Day 1 after; This is a spontaneous report from contactable Other Health Professional, the patient. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 16Feb2021 at 12:45 (at the age of 53-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as "none." The patient has no allergies. Historical vaccinations include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) on 28Jan2021 at 09:00 in the right arm. The vaccine was administered to the patient at a workplace clinic. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were reported as "none." The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she experienced a migraine beginning at 3:30 AM on 17Feb2021 (reported as "on Day 1 and 2 after vaccine") Additionally, she experienced being lightheaded and having slight dizziness and drowsiness beginning at 3:30 AM on 17Feb2021 (reported as "on Day 1"). The patient did not receive any treatment for the events. The clinical outcomes of the events migraine, dizziness and drowsiness were reported as recovered (date not specified). It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
53 2021-03-21 muscle spasms Follow up on report 370952: 03/21 arm pain & swelling at injection site - swelling increased, pain t... Read more
Follow up on report 370952: 03/21 arm pain & swelling at injection site - swelling increased, pain the same, now itchy. 03/21 as with the first shot (Report: 315416), today I developed increased heart rate (I have SVT but controlled with meds), upper abdominal pain, cramping, diarrhea, bloating, inability to eat/drink without stomach pain. It took me 3 weeks to get back to almost normal but to me it appears both shots causes gastrointestinal issues or aggravates existing issues like IBS (which I have). 03/22: At the time of this submission, the heart rate is back to normal, the arm pain & swelling is not as bad but still there. The itching has gone away. The gastrointestinal issues are ongoing.
53 2021-03-22 feeling hot, flushing I stayed at the facility for about ten minutes and didn?t have an issue. They wanted me to stay long... Read more
I stayed at the facility for about ten minutes and didn?t have an issue. They wanted me to stay longer but a homeless person was coughing on me maliciously. I had an epipen and a cellphone with me and walked 3 or so blocks home. On the way home, I noticed my forearm was red and felt hot, though not the side that got the shot and I had a single hive. I thought maybe I had scratched myself. I came home, and my face was very flushed and my skin started burning and itching, mostly my scalp and face, but also my body. I had already taken Pepcid and Xyrtec for allergies I had in the early morning. I added Singulair and Benadryl. I would have called 911 if my breathing had been impaired but I was not asthmatic. The symptoms resolved by later that day after a few hours but I do not believe I will be getting another shot as allergies are often worse on second exposure. It was scary though considering I was already in strong allergy meds. I had some asthma later that night and the following day but not bad. Was very fatigued and dizzy all day.
53 2021-03-22 flushing 1600: Patient c/o feeling increased heart reae, resting HR 57 usually, Now currently 92 and 110 bpm,... Read more
1600: Patient c/o feeling increased heart reae, resting HR 57 usually, Now currently 92 and 110 bpm, flushing. PMHx: SVT, Asthma Meds: Flonase, Flovent, HRT, Levothyroxine Allergies: Sulfa Patient A & O x 4, skin pink, warm and dry, able to tolerate water well. B/P: 192/118, 173/108, 158/100 Provider on duty cleared patient to leave and instructed patient to follow up with PCP for b/p monitoring. Patient communicated understanding and was discharged home.
53 2021-03-22 pain in extremity Left leg started hurting, and swoll up from my knee to my foot, and the next day was told to go to h... Read more
Left leg started hurting, and swoll up from my knee to my foot, and the next day was told to go to hospital. They found a blood clot in my leg .
53 2021-03-22 pain in extremity Extreme fatigue first 3 days that I couldn't get off bed for long; with body aches, arms pain where ... Read more
Extreme fatigue first 3 days that I couldn't get off bed for long; with body aches, arms pain where the shot was given, head aches, sore throat, chills, but had no fever. Arm pain went away after 3 days, body ache wasn't as bad after one week but still had it. But head ache and sore throat every day in the evening. off and on chills continues. and fatigues hits from normal chores. Just walking in grocery stores floors me, or just cooking something.
53 2021-03-22 tingling FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREAT... Read more
FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREATHE. OVER THE NEXT 48 HOURS MY OTHER AREAS WHERE I HAD BEEN BITTEN BY FIRE ANTS AND A HORNET STING BEGAN TO SWELL AGAIN AND MORE BENADRYL AND PEPCID
53 2021-03-22 speech disorder After receiving the COVID immunization client complained of tightness in chest. She had a hard time... Read more
After receiving the COVID immunization client complained of tightness in chest. She had a hard time swallowing and speaking. RN asked if she could swallow Zyrtec and client shook head no. RN asked if she was OK having epinephrine injection and client shook head yes. Three minutes after epinephrine 0.3 injection in left thigh client was able to answer questions appropriately and stated she could breathe better. Vital signs were taken at beginning of client complaints and continued throughout event. EMS called and client was transported to hospital.
53 2021-03-23 feeling cold, cold sweat Symptoms: cold&clammy, lethargic. 2:24pm-per client's son, Paramedics assessed client on site, vital... Read more
Symptoms: cold&clammy, lethargic. 2:24pm-per client's son, Paramedics assessed client on site, vital signs: BP 51/40, pulse 56,O2sat 98, blood glucose 107. 2:27pm Pt. transport from passenger side of personal vehicle to ambulance via stretcher. 2:35pm per Paramedics "client was placed in Trendelendurg position and 500 cc of normal saline given." 2:45pm Final BP 137/87, pulse 68. 2:47pm Client refused to be transported to hospital. Fire Rescue arrived on scene to transport to hospital. Per client, "No". 3:00pm Per Paramedics client stable no further. Evaluation needed client signed a released form. 3:05pm Client released for home at 3:05pm accompanied by son.
53 2021-03-23 pain in extremity Rheumatoid arthritis mostly on left hand Ankle pain on left foot felt like I sprained my ankle. Cou... Read more
Rheumatoid arthritis mostly on left hand Ankle pain on left foot felt like I sprained my ankle. Couldn?t put full weight. Lasted til 2nd vaccine then I got it again even worse on both hands. Could not manipulate a spatula very well, close my hands or grip an object after 2nd vaccine. Left pinky still hurts.
53 2021-03-23 tingling, numbness facial and tongue numbness with tingling
53 2021-03-23 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
53 2021-03-24 feeling hot Dizzy, anxiety, R.S., feels lightheaded, Hot, Rested, gave water, calmed pt down, pt is nervous, no... Read more
Dizzy, anxiety, R.S., feels lightheaded, Hot, Rested, gave water, calmed pt down, pt is nervous, normal behavior for pt per the pt. Nervous for the last 3 days
53 2021-03-24 flushing, tingling 1. Within the hour started feeling lightheaded and on and off feeling like I was going to faint but ... Read more
1. Within the hour started feeling lightheaded and on and off feeling like I was going to faint but didn?t 2. Also feel flushed across my cheeks face that sort of feels hot/prickly -you can visibly see it red across my cheeks 3. Headache Today is day 4 and my lightheaded feeling is worse and I am feeling nauseous and headache is worse.
53 2021-03-24 pain in extremity ?Pfizer-BioNTech COVID-19 Vaccine ? Tremendous pain #7 left wrist and hand. Couldn't make a fist an... Read more
?Pfizer-BioNTech COVID-19 Vaccine ? Tremendous pain #7 left wrist and hand. Couldn't make a fist and couldn't grip anything. This pain lasted 2 days. I took advil and iced which didn't ease the pain. I'm on day 3 and still have slight pain when I use my left hand?
53 2021-03-24 tingling warm and tingly resolved within minutes after symptoms started
53 2021-03-24 tremor, flushing Post COVID Vaccine injection 1639 numbness left lips, tingling in throat and feels tight BP 148/86 ... Read more
Post COVID Vaccine injection 1639 numbness left lips, tingling in throat and feels tight BP 148/86 - HR 75 1643 Epi 0.3 via pen Right thigh Feeling shaking Medical emergency called 1645 Benadryl IM right arm. Feeling flushed ED clinical staff here and transferred in own electric wh/chair. Husband with patient Allergy to CT Contrast - completely swollen shut
53 2021-03-25 discomfort Pfizer-BioNTech COVID-19 Vaccine EUA was administered at 1 pm. Within 10 minutes or less, my vision ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA was administered at 1 pm. Within 10 minutes or less, my vision blurred and the store darkened and felt like it was closing in. I felt dizzy and nausea. I sat down away from people and let someone know. I got a pink in my eyes and some parts of my body. I waited about 45 minutes and my vision cleared and the dizziness faded considerably. The nausea remained and some pinkness remained. Slight headache off and on for two days. Had minor discomfort for two days.
53 2021-03-25 feeling hot Patient states her feet started swelling instantly and she felt nauseated and also felt warm. When ... Read more
Patient states her feet started swelling instantly and she felt nauseated and also felt warm. When her vitals were taken everything was normal. She asked to be transported to have further observation.
53 2021-03-25 feeling hot Right after I got it, my heart started to beat really fast and I got hot. I called my doctor and he ... Read more
Right after I got it, my heart started to beat really fast and I got hot. I called my doctor and he told me to make sure that I'm limiting caffeine. I noticed that it's still happening off and on, so he's ordering a Holter Monitor. Currently waiting for approval to have it done.
53 2021-03-25 flushing, burning sensation Extreme flushing and fatigue, nausea, cough, headache, brain fog, burning sensation in both lungs. T... Read more
Extreme flushing and fatigue, nausea, cough, headache, brain fog, burning sensation in both lungs. The fatigue and nausea still present one week after vaccination.
53 2021-03-25 flushing Patient states she felt flushed, slightly lightheaded and felt short of breathe. Patient taken to am... Read more
Patient states she felt flushed, slightly lightheaded and felt short of breathe. Patient taken to ambulance. no resp. distress noted. no wheezing noted. vital 164/84, 84, 16,100 % RA blood sugar 121 Patient refused transport.
53 2021-03-25 numbness 2 fingers (middle and pointer) on left hand keep going numb.
53 2021-03-25 migraine, pain in extremity Patient experiences chills, fatigue, nausea, migraine, and sore arm. This started the evening of vac... Read more
Patient experiences chills, fatigue, nausea, migraine, and sore arm. This started the evening of vaccination and continued for approximately three days. Symptoms got worse until about day 2-3 when they began to subside more rapidly.
53 2021-03-25 pain in extremity Severe chest pain; Severe headache; Racing Heartbeat; Vomit; Pain in my left side of my arm; Pain in... Read more
Severe chest pain; Severe headache; Racing Heartbeat; Vomit; Pain in my left side of my arm; Pain in my left side of my arm, Shoulder; Dizziness; Very tired; Sleepy; Anxiety; Not knowing where she was; This is a spontaneous report from a contactable healthcare professional (patient). This 53-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) on 22Jan2021 at 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included anemia, gastritis, and peptic ulcer. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient previously received penicillin from an unknown date for an unknown indication and experienced allergy. On 23Jan2021 at 21:00 the patient experienced severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month. The patient went to a doctor or other healthcare professional office/clinic visit as a result of the events. The patient did not receive any treatment for the events. The outcomes of severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month were recovered with lasting effects. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
53 2021-03-26 weakness 03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face ... Read more
03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face especially around my eyes and slight swelling of my eyes, weakness.
53 2021-03-26 discomfort Pain, swelling, lump in left armpit lymph node. Muscle pain and discomfort in body. Pain in left ar... Read more
Pain, swelling, lump in left armpit lymph node. Muscle pain and discomfort in body. Pain in left arm at vaccine location.
53 2021-03-26 feeling cold, flushing Client waited for 15 minutes after vaccine, said she felt "off," but proceeded to her car. Once in h... Read more
Client waited for 15 minutes after vaccine, said she felt "off," but proceeded to her car. Once in her car she noticed she was red, flushed, had one hive on her chest. AT 2:20 She proceeded back into the building and was taken to the emergency area for observation. 2:30 pm, she had bilateral redness in cheeks, BP 138/85, 97% O2, 74 HR., red spot on chest. 2:47pm 97% O2, BP 178/98. 2:55 BP 182/102, Dr called for consultation. Dr. gave verbal order to proceed with IM Benadryl, and monitor for another 15 minutes to see if epi pen was indicated. 3:01, Benadryl given IM in left deltoid. Lot# 080012, expiration: 08/2022. 3:03 O2 97%, HR 80. 3:04, patient became panicked that she could not swallow, Nurse administered Epinephrine autoinjector into left thigh. Lot # 0FM534, Expiration: 9/2022. EMS called 3:06pm. Vital signs stable, client reported feeling cold and had chills. Client reported ease in swallowing almost immediately. Client taken to hospital around 3:15.
53 2021-03-26 numbness, tingling Facility asked to stay for 15 minutes to track for any adverse events. Left the hospital after 20 m... Read more
Facility asked to stay for 15 minutes to track for any adverse events. Left the hospital after 20 min. While driving home approximately 25 after the shot, left hand tingling, left arm numb. Approximately 10 hours pain between shoulder and elbow like someone punched me hard, also nasal congested. The next day I have symptoms like a cold: Nasal congested, voice sounds like I have laryngitis, nasal phlegm is yellow, coughing yellow phlegm, sneezing. Feeling of exhaustion
53 2021-03-26 migraine Chills, fever, extreme muscular pain all over enter body, extreme fatigue, migraine, stabbing pain i... Read more
Chills, fever, extreme muscular pain all over enter body, extreme fatigue, migraine, stabbing pain in inner ears. Most severe symptoms persisted for 2 days and began to subside on day 3. Fatigue remained for an additional 2 days for a total of 5 days.
53 2021-03-26 muscle spasms After 12 hours, lost consciousness for approx 2 min, body had spasms. Had no weakness prior to the e... Read more
After 12 hours, lost consciousness for approx 2 min, body had spasms. Had no weakness prior to the episode, arm wasn?t sore either.
53 2021-03-26 pain in extremity Sore arms, extreme fatigue, hunger, dry mouth/thirst. Symptoms persisted for about 2 to 3 days.
53 2021-03-26 tenderness Swollen and painful lymph node on left collarbone, plus tender-to-the-touch nodes in left armpit. I... Read more
Swollen and painful lymph node on left collarbone, plus tender-to-the-touch nodes in left armpit. I consider this minor compared to contracting COVID-19
53 2021-03-27 tingling Pt was observed post Covid-19 immunization for 15 minutes . During the observation period, she expe... Read more
Pt was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: tingling on L scalp, L Face, L tongue, L arm and L hand. She gave this information to observation nurse after 15 minutes of waiting after getting vaccinated. Pt informed this nurse that she had a migraine before coming in to get vaccinated and the symptoms that were presenting to patient (tingling) usually accompanied her migraines. Pt was taken to an area to be assessed by paramedics. Pt was able to swallow water without difficulty. Per Paramedics, pt is okay to be discharged home. Pt states her tingling in her tongue has gone away but she still has tingling in her L scalp, L hand, L arm. Pt is alert and oriented at discharge and notified to call 911 if symptoms worsened. Pt verbalized understanding of instructions and husband was driving her home today. Pt stated she would take a benadryl at home after being offered benadryl at vaccination site. VS: 140/76, 64hr, 100%02. 123/67, 58hr, 100%02 Assessment : Time of assessment 1548. Alert and oriented. Actions taken: Vitals sign taken VAERS form completed Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 15 minutes. Discharged home. Instructed to follow up with PCP for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.
53 2021-03-27 seizure Systemic: Seizure-Severe, Additional Details: around 5:30pm patient was sitting after her covid vacc... Read more
Systemic: Seizure-Severe, Additional Details: around 5:30pm patient was sitting after her covid vaccine. patient fell face first to the ground and begin to have a seizure. 911 was called and patient was taken to the hospital. Before leaving patient's vitals were back to normal, but was taken to the hospital for obseravation. RPh, and ARNP were performing immunizations at the time.
53 2021-03-28 numbness half of face and upper body feels numb
53 2021-03-28 muscle spasms, feeling of body temperature change Cramping and gas which lead to diarrhea since vaccine. More stomach pain, hot then cold a headache... Read more
Cramping and gas which lead to diarrhea since vaccine. More stomach pain, hot then cold a headache and not hungry on day 3 after vaccine.
53 2021-03-28 muscle spasms 6 hours post injection my lower lip began to have spasms. This continued intermittently for 33 hours... Read more
6 hours post injection my lower lip began to have spasms. This continued intermittently for 33 hours post injection.
53 2021-03-28 pain in extremity I received the 2nd dose on March 24th around 1:30. The 25th I became extremely tired and extremely c... Read more
I received the 2nd dose on March 24th around 1:30. The 25th I became extremely tired and extremely cold. That lasted throughout the night and into the next day where I could not work. I then felt fine, but on Friday evening my right arm throbbed and ached and nothing I took would relieve the achiness and pain. I then developed a raised rash that started around my injection site and has worked it's way to my thumb and pointer finger on my right arm only, They keep multiplying and are raising like hives with little water blisters. They are painful and feverish.
53 2021-03-29 weakness Adverse events experienced and are they still occurring now: Had chills, aches, fever of 101 and a ... Read more
Adverse events experienced and are they still occurring now: Had chills, aches, fever of 101 and a cough. She is still feeling weak and has a cough What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): Home management and has been taking Tylenol once or twice a day
53 2021-03-29 feeling hot Felt a wave of heat from her neck to stomach 3-4 times. 118/66b/p pulse 62 PS02 100% Respirations ... Read more
Felt a wave of heat from her neck to stomach 3-4 times. 118/66b/p pulse 62 PS02 100% Respirations even and unlabored, skin pink warm and dry. No signs of distress. Client monitored for 30 minutes then released. Informed to seek medical attention if any further problems.
53 2021-03-29 flushing dizziness, lightheadedness, flushing to chest and face, pre-syncope, BP 190/100
53 2021-03-29 migraine Migraine
53 2021-03-29 throat numbness Swollen tongue, numbness in the back of throat
53 2021-03-30 feeling cold Around 12 PM start to feel a little chilly and neck aches a bit (it was a little colder today so di... Read more
Around 12 PM start to feel a little chilly and neck aches a bit (it was a little colder today so didn?t think too much of it and thought neck aches were from shrugging when a little chilly). By 1:30-2 PM, was pretty chilly and wrapped up in sweatshirt and fleece jacket. By 3:30 PM used heating pad and blanket but still cold. From 4-6 PM added another heating pad and 3 blankets totally covered from head to toe. Got up at 6 PM and took temperature and it was 102.1. (Don?t know if accurate since bundled up to much) neck aches more pronounced and giving me headache. Only lightly covered with blanket now so warming up finally 7:45 PM temp is 101.2. Whole body just achy now but especially low back.
53 2021-03-30 flushing Pt had a bad reaction to the second vaccine. She had body aches, fever/chills, sweating, headache fo... Read more
Pt had a bad reaction to the second vaccine. She had body aches, fever/chills, sweating, headache for about 12 hours after the vaccine, then the next day face was bright red with a rash bumps all on her face and down to her chest denies itchiness to the bumpy area. Significantly flushed. Wednesday today her rash is almost resolved but her face is "puffy" visibly looks puffy on video. She has taken benadryl, zyrtec, tylenol without much improvement to symptoms. Pt to continue symptom management at home with benadryl, zyrtec and tylenol. Aloe and otc hydrocortisone to the face since it feels raw per pt report. Rash is resolved. Pt instructed if it returns to let us know. No steroids at this time as they would negate the response of the vaccine in the body.
53 2021-03-30 numbness Pfizer-BioNTech Covid-19 Vaccine Swelling of face, lips and throat / Numbness
53 2021-03-30 migraine COVID-19 confirmed by positive COVID-19 test; high levels of histamine; hives on back and chest; sho... Read more
COVID-19 confirmed by positive COVID-19 test; high levels of histamine; hives on back and chest; shortness of breath; blood pressure of 80/50; pneumonia; fever; chills; migraine; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205, expiry date: unknown), via an unspecified route of administration in the right arm, on 26Feb2021 14:30, as single dose, for covid-19 immunization, at a health department. Medical history included known allergies to latex and egg whites. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccines in 4 weeks. On 26Feb2021 at 17:00, 3 hours after the vaccine, the patient experienced fever, chills and migraine which went on for 4 nights (as reported). On 03Mar2021 (reported as "fifth night"), the patient started to have high levels of histamine, hives on her back and chest and shortness of breath for three days (as reported). In Mar2021 (reported as "by the weekend"), the patient went to urgent care, underwent x-ray of chest, and had pneumonia. In Mar2021 (reported as "Monday"), the patient came back with blood pressure of 80/50 and was sent to the emergency room (ER). It was reported that the events pneumonia, fever, chills, migraine, high levels of histamine, hives on back and chest, shortness of breath and blood pressure of 80/50 required physician office and emergency room visits; treatment for these events included fluids, potassium and antibiotics (unspecified). On 06Mar2021, the patient underwent COVID nasal swab which resulted to positive. The patient recovered from events fever, chills and migraine on 02Mar2021; and from high levels of histamine, hives on her back and chest and shortness of breath on 06Mar2021. The outcome of the events pneumonia, "blood pressure of 80/50" and "COVID-19 confirmed by positive COVID-19 test" was unknown.
53 2021-03-30 pain in extremity swelling to left underarm lymph node; pain at site; left arm "ache" with decrease in strength; This ... Read more
swelling to left underarm lymph node; pain at site; left arm "ache" with decrease in strength; This is a spontaneous report from a contactable other hcp. A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: El3249, expiration date: not reported) via an unspecified route of administration, administered in Arm Left on 27Jan2021(at the age of 53 years) as single dose for COVID-19 immunization. Medical history included hypothyroidism , migraine and rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included thyroid taken for an unspecified indication, start and stop date were not reported. The patient also took BCP in two weeks. The patient previously took cipro and experienced drug hypersensitivity, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ek9231, expiration date: not reported) via intramuscular route of administration, administered in Arm Left at 09:15 on 06Jan2021 as single dose for COVID-19 immunization and experienced malaise. The patient experienced swelling to left underarm lymph node, pain at site and left arm "ache" with decrease in strength on 28Jan2021. The outcome of events was recovering.
53 2021-03-30 tingling right leg paresthesia; This is a report from an interventional study managed and reported by Pfize... Read more
right leg paresthesia; This is a report from an interventional study managed and reported by Pfizer on the sponsors behalf. A 53-year-old female subject received the first dose of blinded vaccine therapy (BNT162;PLACEBO) on 14Aug2020 at 11:33 and the second dose on 04Sep2020 at 13:13, both via intramuscular (IM) in the left deltoid as single doses for immunization. The subject's medical history includes ongoing chronic migraines (from 2008); neck pain since 2008 with temporary relief from chiropractic manipulation; osteopenia; vitamin D deficiency (2013 to 2014) controlled with Vit D supplements until now; Vit B12 deficiency. In 2014, the subject was diagnosed with occipital neuralgia, right greater than left. She got a steroid injection and did a one-month oral steroid taper, both without relief. She declined to try gabapentin, pregabalin (LYRICA) or other neuropathic pain medications. In addition, the chronic migraines occur 1-2 times per month requiring multiple therapeutic interventions (including B2/Mg, doxepin, zolmitriptan (ZOMIG) as needed (PRN)) and had an episode of intractable chronic migraines without aura and status migrainosus treated with botulinum toxin type A (BOTOX) in 2016. She had experienced relief with botulinum toxin type A and zolmitriptan. Per neurology visit on 01Mar2016, the subject did not feel a typical aura for the migraines, she may have some scalp tenderness or neuralgia-like feeling. She had never had a complicated migraine. Subject's family medical history relevant to adverse event was none. The subject had no concomitant vaccines or prior vaccines (within 4 weeks). Concomitant medication included zolmitriptan for migraines from 2008, vitamin D from 2013 as supplement, both ongoing. On 20Oct2020, the subject started experiencing right leg paresthesia, which required a visit to the physician's office and was considered as an important medical event. On 28Oct2020 the subject underwent a nasal/sinus surgery after which she was given codeine phosphate/paracetamol for three days. On 02Nov2020, she had lower back pain and bilateral lower extremities pain including a shooting "patchy" pain, worse on the right side. Her legs and parietal scalp were sensitive to touch with an associated burning pain. She also reported tenderness in bilateral inguinal area. Symptoms had a gradual onset approximately 3 weeks before. Subject had a magnetic resonance imaging (MRI) of her back which appeared "ok" but she had not seen her primary care physician (PCP) or a neurologist. She denied a history of neurologic or lower back problems. Investigator had a follow-up on 10Nov2020. The paresthesia and skin sensitivity on head had improved but not resolved. Subject still required use of analgesic daily. At its worst, her pain was 6-7/10 in severity. When symptoms started, pain severity was 8-9/10 for a couple of weeks. Without use of analgesic, she had significantly decreased level of activity. But the pain did not prevent activity. With analgesics, she was able to function adequately despite persistence of a mild constant pain of lower back and legs which rates as 1-2/10 in severity. She had required use of some form of analgesic since pain started on approximately 20Oct2020. She had used paracetamol (TYLENOL), ibuprofen (ADVIL), codeine phosphate/paracetamol (TYLENOL#3), and most recently celecoxib (CELEBREX). She said the pain started on approximately 20Oct2020 but then said it started closer to 5 weeks after vaccination 2. She had not noticed any exacerbating factors. Subject denied any recent injury, travel, infection, or change in diet. She went for a walk on 10Nov2020 and walked approximately one mile without a problem. She stopped walking by choice not due to pain. Initially, adverse event was not reported since there was no official diagnosis and symptoms were believed to have occurred approximately six weeks after second vaccination. Despite still not having an official diagnosis, investigator had opted to report this as an important medical event since symptoms had persisted and the subject believed they started closer to five weeks after vaccination which was close to the four week post-vaccination observation period. Medical records from the neurologist were obtained. Per the note from 06Nov2020, MRI of cervical spine done several years before showed mild degenerative changes and spondylosis. MRI of lumbar spine recently done by subject showed: "degenerative discopathy, small left central disc protrusion at T5-T6 with minimal indentation thecal sac; No spinal cord compression, spinal canal stenosis or neural foramina narrowing; Multilevel hypertrophic changes of the facets within the lumbar spine with no neural foramina stenosis; Incidental finding multilevel small hemangiomas in cervical and thoracic vertebral bodies." Neurologic exam on 06Nov2020 was normal Including gait and tandem walk. Tenderness was noted in lower extremities musculature bilaterally throughout and large mobile inguinal lymph nodes palpable bilaterally. Lab ordered by neurologist were normal including Vit B12 635 (200-960PG/ML), Folate 19.6 (equal and more than 6.0UG/L), Vit D 25-Hydroxy 33 (30-100NG/ML), Total creatine phosphokinase (CK) 45 (28-176U/L), erythrocyte sedimentation rate (ESR) 15 (0-20MM/HR), C-Reactive Protein 0.3 (less than 0.5MG/DL), serum aldolase 3.9 (1.5-7.2U/L), thyroid stimulating hormone (TSH) 1.130 (0.400-4.100UIU/ML), FREE T4 1.42 (0.80-1.90 NG/DL), lyme antibody 0.25 (Negative less than 0.9), antinuclear antibody (ANA) negative; serum protein electrophoresis normal, no monoclonal protein seen. Neurologist impression included possible post-viral syndrome or an autoimmune process. There was no mention of concern for myelitis or plan for further work-up. Neurologist's recommendation was to continue celecoxib, PRN and follow-up with primary care physician if labs were unrevealing. Plan to have subject return to clinic to obtain more in-depth history and possibly some labs as well as request reports of MRIs. On 01Mar2021, the subject was seen for visit4, it was confirmed that the event was ongoing but continuing to improve. The action taken for blinded vaccine therapy in response to the event was not applicable. The outcome of the event was recovering. The investigator considered there was a reasonable possibility that the event "right leg paresthesia" was related to blinded vaccine therapy (temporal relationship only, possible due to no other obvious potential etiologies), but unrelated to concomitant drugs or clinical trial procedure. On 18Nov2020, the blinded code was broken due to serious, related, unexpected event. Follow-up (10Dec2020): This is a follow-up report based on the receipt of the publication: No new information provided. Follow-up (23Mar2021): New reported information included: clinical course (on visit4, confirmed that the event was ongoing but continuing to improve).; Sender's Comments: The event Paresthesia Lower Limb is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product blinded therapy vaccine (BNT162;PLACEBO). There is not a reasonable possibility for the event paresthesia lower limb to be related with the blinded therapy vaccine (BNT162; PLACEBO). As an individual case report, there is not enough evidence to establish a causal relationship with the study vaccine apart from a chronological association at this time of the report. Based on the information currently available, it is more likely that the event is associated with the subject's underlying known neurological conditions. The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate.
53 2021-03-31 hot flush, pain in extremity Soreness in arm and muscle aches lasting several days. Hot flashes lasted 3-4 days. Headache and f... Read more
Soreness in arm and muscle aches lasting several days. Hot flashes lasted 3-4 days. Headache and fatigue still lasting one week later. Swollen lymph nodes in neck and mild sore throat noticed approximately 5 days after and still lasting one week after shot.
53 2021-03-31 hot flush Patient presents with "hot flash" feeling and a little bit dizzy. Alert & oriented. Insulin depend... Read more
Patient presents with "hot flash" feeling and a little bit dizzy. Alert & oriented. Insulin dependent diabetic - did not take insulin this AM. She did not think this was hypoglycemia. Vital signs stable throughout observation period. Initial BP - 135/87, Pulse - 94, O2 sat - 99%. All symptoms were self-resolving with time. Not orthostatic and ambulated s problem before discharge
53 2021-03-31 numbness SOB, numbness, tingling lips. Evaluated by EMS-Transported to Emergency room/department or urgent ca... Read more
SOB, numbness, tingling lips. Evaluated by EMS-Transported to Emergency room/department or urgent care.
53 2021-03-31 numbness Entire face felt number about 20 minutes after the vaccine was administered, second day from nose to... Read more
Entire face felt number about 20 minutes after the vaccine was administered, second day from nose to side of head felt numb, on the third day cheek and temple feel numb. Each day the numbness is less noticeable.
53 2021-03-31 tremor The patient reported shakiness and tightness in the throat muscles without any issues with breathing... Read more
The patient reported shakiness and tightness in the throat muscles without any issues with breathing. Her blood pressure was 154/91 and pulse was 62. After sitting and relaxing she eventually felt well enough to leave.
53 2021-04-01 difficulty speaking, tenderness extreme neck stiffness, soreness on complete neck - all the way around and inflamed glands - hurts t... Read more
extreme neck stiffness, soreness on complete neck - all the way around and inflamed glands - hurts to turn or tilt head - sore to touch and affecting swallowing and voice - raspiness and cracking - dryness of throat
53 2021-04-01 electric shock sensation, speech disorder difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty s... Read more
difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; had a lot of mucus in my throat; difficulty breathing; asthma acting up; lethargic; dehydrated; headaches; immobility; fever; chills; muscle aches; stiffness; electrical shocks up and down my body; fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot Number: EN6202), at the age of 53-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, multiple sclerosis, seasonal allergies, dust, animals. The patient did not have COVID prior vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included glatiramer acetate (COPAXONE); lamotrigine (LAMICTAL); risperidone (RISPERDAL); alprazolam (XANAX); salbutamol (ALBUTEROL HFA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took dilaudid and experienced allergies. On 04Mar2021 17:00, the patient got fever, chills, headaches, muscle aches and stiffness. The patient treated the symptoms with ibuprofen and ice packs. The next day, on 05Mar2021, the patient had difficulty swallowing, chewing and speaking. The patient had a lot of mucus in my throat and difficulty breathing from asthma acting up. The patient was very lethargic and dehydrated. The patient had to use inhalers, benedryl and musinex to treat symptoms. The patient had the chills, headaches, fever and aches through Tuesday, 09Mar2021. The patient touched base with her general practitioner's and neurologists' offices on March 5 & 6 and left messages. They suggested she go to the ER. (She didn't go out of fear of getting COVID), she was too fatigued and weak to walk. No balance. She had electrical shocks up and down her body. The patient was still experiencing immobility and fatigue. The outcome of the events chills, headaches, fever and aches was recovered on 09Mar2021; the other events were not recovered. The patient was not tested for COVID post vaccination.
53 2021-04-01 flushing Approximately 4 to 4 1/2 hours after vaccine notice cheeks getting red, feeling flushed. Got more a... Read more
Approximately 4 to 4 1/2 hours after vaccine notice cheeks getting red, feeling flushed. Got more and more warm to touch. No fever. Gradually moved to high on cheekbone. Took Tylenol and went to bed for night. At 24 hours after vaccine still continued redness, a bit of swelling under eyes and high on cheekbone. took tylonol. At 5;30pm took Benedryl. At 8:00pm noticed and felt swelling in bottom lip. Went to ER. Now 48 hours after Vaccine and two 60 mg. of Prednisone still very red, hot flushed cheeks. No more swollen lip. Taking Pepecid, Zyretc, and Benedryl. Presciption is to taper down on Prednisone 2X60, 2X50 and so on.
53 2021-04-01 hot flush, numbness Numbness on the roof of my mouth, near my throat. Hot flashes, sweating, high blood pressure, the fe... Read more
Numbness on the roof of my mouth, near my throat. Hot flashes, sweating, high blood pressure, the feeling of passing out, super hot throughout my body. Numbness in left cheek and upper lip. Swelling in left cheek and left eye. Dizzy.
53 2021-04-01 tingling pt vaccinated at 1106, was at observation area pst vaccination then 19 mins post injection c/o tingl... Read more
pt vaccinated at 1106, was at observation area pst vaccination then 19 mins post injection c/o tingling on lips/cheeks, halds felt funny the had chest tightness, MD, RNs responded , vital signs stable. Discharged AMA at 1142 AM, stable.
53 2021-04-01 tingling Ct. c/o tingling in the left arm 10 minutes after receiving vaccine. Client denies any other sympto... Read more
Ct. c/o tingling in the left arm 10 minutes after receiving vaccine. Client denies any other symptom and was seen by EMT. Vital assessments are BP 188/115, HR 72, O2 99. Ct. appears calm. Client verbalized that she was just given a new prescription for HTN med but had not started and had been monitoring her BP for a week. Ct. advised to notify MD of finding and cleared to go home by EMT.
53 2021-04-01 cold extremities Hot thighs and cold hands; no fever. Fatigue. Brief chills. Took 2 Tylenol and went to sleep unu... Read more
Hot thighs and cold hands; no fever. Fatigue. Brief chills. Took 2 Tylenol and went to sleep unusually early.
53 2021-04-01 tenderness My left are is still swollen and is a little tender to touch. There is a big lump on my upper arm.
53 2021-04-01 tremor 9:47am Stated after vaccination started to feel a little lightheaded and shaky, heart racing. BP 16... Read more
9:47am Stated after vaccination started to feel a little lightheaded and shaky, heart racing. BP 166/72, HR 112, O2 98%. 9:58am Stated heart felt better. Advised if symptoms return, pull over safely and dial 911.
53 2021-04-02 feeling hot, numbness 58 y/o female, s/p 1st vaccine. C/o hotness to throat and intermittent right hand numbness. Speech ... Read more
58 y/o female, s/p 1st vaccine. C/o hotness to throat and intermittent right hand numbness. Speech clear, drinking water, a/o x4; medic 71 on scene, care assumed. Pt signed out AMA. Symptoms resolved.
53 2021-04-02 pain in extremity, cold sweat, tremor, feeling cold Guest complained of right arm radiating pain to her right hand. Cold, clammy, diaphoretic, and shaki... Read more
Guest complained of right arm radiating pain to her right hand. Cold, clammy, diaphoretic, and shaking. Alert and Oriented x 4. B/P: 100/60, P ? 56, R ? 16, SPO2 ? 98%, and blood glucose reading was 85. Client reports she has a history of anxiety with injections and medical procedures. Juice with sugar provided along with 8 ounces of water. EMS provided further assessment with VS reading of: B/P: 118/70, P ? 68 SPO2 ? 99%. Guest provided 20 more minutes of observation and released with no further interventions.
53 2021-04-02 pain in extremity, slurring About 5 hours after vaccination, I started feeling very tired that I had to tell my employer that I ... Read more
About 5 hours after vaccination, I started feeling very tired that I had to tell my employer that I wouldn't be able to continue working much longer. I work from home at a computer. After 6 hours after vaccination (4 pm), I was so exhausted that my mouth muscles were too weak to be able to speak strongly. My muscles were too relaxed that I needed to lie down at this point. Inside my mouth, near my lips, there was a warming sensation (no pain). I've never experienced that before. It didn't last long. After about 6.5 hours after vaccination as I was in bed, I felt a little pain in my right thigh for an unknown reason. For a few seconds I felt a little nauseated so I kept a kidney dish near my head in bed. I slept in a deep sleep for at least 2 straight hours. I woke up groggy and with a very dry mouth. I usually drink a lot of water in my typical day, but after my vaccine I do not recall being unusually thirsty. I may have inadvertently dehydrated myself. That night after my vaccination I had a very dry mouth while sleeping. When I woke up each time, I would drink a little water. That carried over to the 2nd night after my vaccination, despite drinking a lot of water that day. Meanwhile, I had not had any alcohol, coffee, nor any caffeine during this entire time.
53 2021-04-02 pain in extremity Whole arm aches today. Injection site warm to touch and armpit lymph node very swollen
53 2021-04-03 pain in extremity Sore arm; fatigue; This is a spontaneous report from a contactable consumer (patient). This 53-year-... Read more
Sore arm; fatigue; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL3247) via an unspecified route of administration on 18Feb2021 at 11:25 (at the age of 53-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Type 2 diabetes since Sep2017. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously received dose 1 of BNT162B2 (lot number EL3247; expiration date May2021) intramuscularly on 27Jan2021 as a single dose in the left arm for COVID-19 immunization. Concomitant medications included metformin from 3 or 4 years ago as of 2021 for an unspecified indication, colecalciferol from over 10 years ago as of 2021 for an unspecified indication, omega-3 fatty acids from at least 4 years ago as of 2021 for an unspecified indication. The patient previously received azithromycin on an unspecified date for an unspecified indication and experienced full body itchy hives/rash. On 18Feb2021, about six hours after the second dose of BNT162B2 the patient experienced sore arm. The following day (also reported as 48 hours later) the patient experienced fatigue. The patient was not hospitalized for the events and did not visit a physician's office or emergency room for the events. The patient did not receive any treatment for the events. The outcomes of sore arm and fatigue were recovered. No follow-up attempts are needed. No further information is expected.
53 2021-04-03 pain in extremity Severe sore arm. Then it went away after about 24 hours then came back 7 days later.
53 2021-04-03 tingling, pain in extremity Sore arm, fatigue, lightheaded, headache, tingling in extremities . All mild, able to continue with ... Read more
Sore arm, fatigue, lightheaded, headache, tingling in extremities . All mild, able to continue with daily tasks Resolved by 2 days after vaccine. Used Ibuprofen and Excedrin migraine for symptoms.
53 2021-04-03 tenderness Swollen lymph nodes on left side of neck and in left armpit area. Tender to the touch. General ache... Read more
Swollen lymph nodes on left side of neck and in left armpit area. Tender to the touch. General aches and injection site soreness. All symptoms are on the left side, the same side of the injection site. Started around 4 pm on Friday 4/2/2021. I took 500mg of Tylenol on Friday at 8pm, and at 2am on Saturday 2/3/2021.
53 2021-04-04 electric shock sensation, pain in extremity The second vaccination pinched more than the first one, my arm was sore like it was with the first v... Read more
The second vaccination pinched more than the first one, my arm was sore like it was with the first vaccination, but the following day I noticed a twingeing sensation almost like a zapping electrical shock on the inside of the injection ar m just below my armpit when I move my arm
53 2021-04-04 flushing, burning sensation 53 y/o woman presented for her first COVID vaccine. She had hx of allergic reaction to IV Contrast i... Read more
53 y/o woman presented for her first COVID vaccine. She had hx of allergic reaction to IV Contrast in 2006 and 2014 - within minutes of receiving IV contrast for an imaging study she developed throat closing, difficulty breathing and vomiting. She has tolerated vaccinations and IV medications in the past without any problem. She also tolerated bowel prep for her colonoscopy a few years ago. Denies known allergy to PEG. I sent secure chat to her PCP and received approval to proceed with vaccination today. The patient was warned of the increased risk of allergic reaction to the COVID vaccine due to her allergic reaction to IV Contrast in the past. She expressed understanding and stated she still wanted to receive the vaccine despite the increased risk. 10 min after receiving the vaccine she developed significant nausea and dry heaving. Vitals were within normal limits. Physical exam was unremarkable except for anxiety and vomiting. 18 min after the vaccine she developed lightheadedness and a headache. 27 min after the vaccine she developed diaphoresis and a sore throat. Vitals and physical exam were monitored closely. 30 min after the vaccine she developed itching of her ears, nose and posterior pharynx. She also c/o burning sensation from her nasal passage to her throat. She had coughing and throat clearing. Vitals were unremarkable. Exam revealed increased distress. 35 min after the vaccine she suddenly developed tightness of her throat associated with worsening throat itching and difficulty breathing. Vitals: HR 110, Spo2 94%, BP 136/80, RR 20 PE: A&Ox4, appears anxious and is in acute distress, she had hands around her throat. Cardio: tachycardic rate, regular rhythm, radial pulse 2+ Pulm: Tachypnea noted, lungs clear to auscultation, no wheezing, cap refill < 2 sec Skin: facial flushing noted, diaphoresis resolved, no urticaria, no swelling or erythema at injection site. Expressed to patient that I was concerned about an allergic reaction occurring and described my next steps of administering EPI and calling EMS. She was agreeable. EMS was called by CMA. Epi Autoinjector 0.3 mg injected into RIGHT upper outer thigh at 10:57 AM Her throat tightness, throat/ear/nasal itching, throat clearing, cough, lightheadedness and headache all resolved within 10 min after the EPI was given. Oral benadryl 25 mg was given. EMS arrived at 11:18 AM and took over care. The patient was agreeable to be transferred to ER for further monitoring.
53 2021-04-04 pain in extremity Severe muscle pain on left side. Neck, shoulder, scapula, arm. Seems to move - one day in one plac... Read more
Severe muscle pain on left side. Neck, shoulder, scapula, arm. Seems to move - one day in one place and then another day at a different site. All on the left side though which is the arm I had the shot in.
53 2021-04-06 burning sensation Body aches beginning in the middle of the night, in process of subsiding now but back and body is st... Read more
Body aches beginning in the middle of the night, in process of subsiding now but back and body is still sore Intense itching/burning of hands and feet, beginning about midnight and waking me about every twenty minutes until dawn. Gone now.
53 2021-04-06 flushing, feeling hot This is a spontaneous report received from a contactable Consumer, the patient. A 53-years-old non-p... Read more
This is a spontaneous report received from a contactable Consumer, the patient. A 53-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, lot number, expiration date: not available) via an unspecified route of administration on left arm on 24Mar2021 09:15 at single dose for COVID-19 immunisation. The patient's medical history included Gastroparesis, allergies to medications, food, or other products: latex, yeast, wheat, guafanisen and Dextromethorphan. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:15 AM, patient experienced anaphylaxis within minutes of having the injection and began to feel flushing down throat, then down to chest. That was concerning but when suddenly, patient got really hot, ripped her mask off, and she realized that she was having difficulty breathing and it got worse as time went on, it was resulted in Emergency room/department or urgent care. Patient received Epi-pen, Benedryl, fluids as the treatment for the events. The outcome for the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
53 2021-04-06 night sweats Elevated heart rate, heart rate spiked to 178 for no reason (just normal grocery shopping). Heart r... Read more
Elevated heart rate, heart rate spiked to 178 for no reason (just normal grocery shopping). Heart rate while making a sandwich 111 (on apple watch) normal heart rate while warming up in spin class is 99, with heart rate max during spin climb of 170. Was feeling very fatigued, bad headache and night sweats 24 hours after vaccine. Elevated heart rate at approximately 48 hours post vaccine.
53 2021-04-06 pain in extremity, tingling Afternoon of second vaccine- malaise and sore arm. 1/15- body aches, malaise, sore arm, swelling of ... Read more
Afternoon of second vaccine- malaise and sore arm. 1/15- body aches, malaise, sore arm, swelling of arm and tingling in hand that lasted 3 weeks. Red injection site with hard 3 inch diameter at the injection site. 1/15- chills and sweating, but no increased temperature 1/16-18- malaise, body aches, swollen lymph nodes in right axilla.
53 2021-04-06 tingling Patient came for second dose of covid vaccine. Shortly after receiving the vaccine. Patient reporte... Read more
Patient came for second dose of covid vaccine. Shortly after receiving the vaccine. Patient reported of having tingling of hands and swelling of tongue. Pharmacist gave patient a dose of 0.3mg EpiPen injection and call 911. Patient was alert and able to talk. Patient went with paramedics to the hospital to get checked out.
53 2021-04-07 weakness, numbness, tingling High fever 102.2 Chills, body aches, total body pain and weakness headache burning eyes pain in arm ... Read more
High fever 102.2 Chills, body aches, total body pain and weakness headache burning eyes pain in arm at site of injection with numbness and tingling down arm post vaccination
53 2021-04-07 weakness patient began feeling headache, achiness evening of injection. Now presenting with weakness, low-gr... Read more
patient began feeling headache, achiness evening of injection. Now presenting with weakness, low-grade fever, dizzy, nauseated. and pain throughout body.
53 2021-04-07 bell's palsy Pt developed bell's palsy 4 days following the 1st dose of the vaccine. She went to ER and was diagn... Read more
Pt developed bell's palsy 4 days following the 1st dose of the vaccine. She went to ER and was diagnosed with Bell's palsy.
53 2021-04-07 slurring Pt went to stand up right after receiving the vaccine and immediately passed out on the floor. Upon ... Read more
Pt went to stand up right after receiving the vaccine and immediately passed out on the floor. Upon examining the pt, pt stated she was dizzy after receiving the vaccine and we thought she just stood up too fast. Observed pt for several minutes, pt vomited shortly after and remained dizzy and sweaty. After about 30 minutes, pt stated she felt better and wanted to go on to work. While walking down the hallway to leave, pt passed out again. Contacted 911, pt had blurred vision, dizziness, slurred speech. Ambulance arrived, BP and HR were normal, but pt couldn't stand up unassisted. Pt was taken to the ER by ambulance.
53 2021-04-07 feeling hot Tuesday 6 go the first Pfizer Covid vaccine at the race track. In the past I have had angioedema and... Read more
Tuesday 6 go the first Pfizer Covid vaccine at the race track. In the past I have had angioedema and breathing issues but never severe enough to warrant going to hospital with several injections and from over the counter meds and prescription meds. So I was wary but decided to risk a jab. Straight up got tingling tongue and lips but after 15 min was just dizzy and roughly the same feeling. I am a slow up taker and excreter though. By the time I got home, about 20 min after the 15 min wait my neck on the injection side and swelled so much I no longer had a jaw and my eyes and cheeks were pretty puffy. Then the breathing issue started. I called the gp who said Tylenol, benedryl. Usually have them made because I have problems with additives but i don?t have any right now. So I used two ea kids chewable which allow me to have a dosage that works for me as I am sensitive to larger doses which can cause pvcs. Things were better but not good enough so took Zyrtec 10 ml/24 hr. If I had not had a similar experience with other injections this would have completely freaked me out. Thank goodness my quick treatment worked well enough that I felt confident worse was unlikely to happen, though the gp and allergist both wanted me to go to the er. Yesterday I did a repeat of Tylenol and benedryl in the morning and Zyrtec in the afternoon at two pm then Tylenol and benedryl again in the evening as I still had angioedema and felt tight in breathing. Repeat benedryl and Tylenol today but no Zyrtec as felt good enough to ride stationary bike a very slow Five miles. As to fever and other typical symptoms it has been hard to tell what is reaction and what is simply the vaccine doing its job. I did not take my temperature but have felt hot no general malaise. I recognize my symptoms are unusual but felt you should have them.
53 2021-04-07 feeling hot About a week after my COVID-19 shot my arm became very itchy, red and warm. There was a swollen hard... Read more
About a week after my COVID-19 shot my arm became very itchy, red and warm. There was a swollen hard bump where the injection had been given that was a bit tender. It remained that way for a couple of days. Now, more than two weeks out from the injection I still get itchy from time to time.
53 2021-04-07 numbness, pain in extremity Patient came back 2 days after vaccination and stated the RN that gave her vaccination gave it too h... Read more
Patient came back 2 days after vaccination and stated the RN that gave her vaccination gave it too high on her shoulder. She experienced pain, numbness, decreased mobility in the arm. Patient stated pain is decreasing and mobility has improved. CDC was called to confirm what next steps would be in regards to vaccination. They advised report the incident, do not repeat first dose, and receive second dose as scheduled. Patient was notified of CDC recommendation, she will return for her second vaccine, and was advised to contact Physician if shoulder symptoms worsen or persist. Patient confirmed understanding and was thankful for the prompt attention to this matter.
53 2021-04-07 numbness, tingling NAUSEA, NUMBNESS AND TINGLING IN LEFT ARM. OCCURRED WITHIN 15 MINUTES WHILE PATIENT WAS STILL IN STO... Read more
NAUSEA, NUMBNESS AND TINGLING IN LEFT ARM. OCCURRED WITHIN 15 MINUTES WHILE PATIENT WAS STILL IN STORE WAITING AFTER HER IMMUNIZATION
53 2021-04-07 pain in extremity 4/2/21 1 - non-injection arm felt frozen solid, 30 minutes 2 - concurrent with 1, severe chills, 30 ... Read more
4/2/21 1 - non-injection arm felt frozen solid, 30 minutes 2 - concurrent with 1, severe chills, 30 mins 3 - after 1 and 2 resolved, extreme pain in both hands, 1 hour, acetaminophen and naproxen 4a - concurrent with and after 3, major headache (both sides of forehead and all sinuses), acetaminophen and naproxen 2x more that day, loratadine, no relief 5a - concurrent with 4, aches and pains in most muscles and joints, acetaminophen and naproxen 4/3/21 4b - continued headache (both sides of forehead), acetaminophen and naproxen 5b - continued aches in pains in muscles and joints 4/4/21 8a - pale-ish red patch on injection arm, boarders not well defined, warm to the touch, below injection site, grew as day went on 5c - continued aches in pains in muscles and joints 4/5/21 8b - red patch continued to spread 4/6/21 8c - red patch continued to spread, Dr. diagnosed as cellulitis, started on doxycycline and loratidine 4/7/21 8d - red patch started going away
53 2021-04-08 weakness Headache, muscle aches, weakness, fever, pain at injection site
53 2021-04-08 burning sensation, pain in extremity The day after I received my vaccination I started experiencing sharp, shooting, burning pain that sh... Read more
The day after I received my vaccination I started experiencing sharp, shooting, burning pain that shoots down my arm to my middle finger tip and tip of thump and up my next to the base of my skull as if an electrical current was running through my arms. Nothing seems to stop the pain.
53 2021-04-08 feeling cold Patient received first dose of Pfizer at 12:50 pm on left deltoid, lot # ER8731, expiration date on ... Read more
Patient received first dose of Pfizer at 12:50 pm on left deltoid, lot # ER8731, expiration date on 07/2021. Patient has a history of rheumatoid arthritis and asthma, both of which are controlled with medication. Patient waited in outdoor EMT waiting area for approximately 20 minutes. At 12:09 pm, patient entered indoor EMT waiting area and asked the lead nurse, if she could check her blood pressure. Upon assessment, patient was alert, oriented X4, clear speech. The patient's primary complaint was "feeling tired". The patient sat down in a chair in the observation area while RN took her blood pressure. At 12:09 pm, the patient's BP 156/102 sitting, HR 68, SpO2 97% RA, RR 17 res/min unlabored. Patient denies tightness in chest or throat, difficulty breathing, or trouble swallowing. Patient states she did not drink water today. RN gave patient a water. Patient consumed 16 oz of water at 1:13pm. Patient reports she is "feeling better" at 1:13 pm. At 1:16 pm, the patient's BP 156/102 sitting, HR 75, RR 18 res/min unlabored. Patient states her blood pressure "is usually low" because she runs daily, but she "can't remember" her usual range. At 1:20 pm, BP 150/100 sitting, HR 66, RR 18 res/min unlabored. Patient states she is "feeling tired and cold". Patient was transferred to anti-gravity chair at 1:25 pm with assistance from EMT. At 1:25 pm, patient's BP 167/115, RR 20 res/min, HR 64. At 1:32 pm, patient called her brother to come pick her up. Patient was provided with education related to signs and symptoms of allergic reaction, such as tightness in throat, tingling of tongue, and shortness of breath. Patient denies experiencing such symptoms. At 1:32 pm, BP 150/90, HR 70, Spo2 at 99%, RR 20 res/min. Patient states "I felt like something bad was going to happen" after receiving her vaccine. EMT talked with patient calmly and encouraged deep breathing. At 1:39 pm, BP 164/88, HR 84, Spo2 at 98%, RR 20 res/min. At 1:42, the patient requested to leave. Lead RN, advised patient to stay laying down and deep breath to help her blood pressure go down. Patient states "I want to leave". Patient was provided with education about normal blood pressure ranges. Patient verbalizes understanding and states she is aware she needs to call her doctor if she is experiencing headaches, vision changes, and/or chest pain. At 1:45 pm, patient got up out of chair and followed by EMT to car. Patient's gait was steady and balanced. Patient states she is "okay to drive". Patient declined having more vitals taken. Patient left with brother in passenger seat of car at 1:47 pm.
53 2021-04-08 migraine site of injection, LUA, muscle soreness and unable to life L arm. Still unable to life left arm com... Read more
site of injection, LUA, muscle soreness and unable to life L arm. Still unable to life left arm completely without pain. I'm a nurse, so doing my own physical therapy. BUT, main issue has been daily headaches. I've had more headaches in the last 3 months since vaccine, then I have had in my entire life. no treatment except Tylenol or ibuprofen. Although, the other day I had a severe headache, with visual disturbance, vertigo with dizziness and nausea. Was treated at local ER for possibly stroke. MRI showed no issues. I am now diagnosed with migraines.
53 2021-04-08 pain in extremity, feeling hot Got vaccine on 4/7 at 10-10:30 am approximately By 1 pm I was sleepy and woke up at 3 By 4-5 pm I h... Read more
Got vaccine on 4/7 at 10-10:30 am approximately By 1 pm I was sleepy and woke up at 3 By 4-5 pm I had chills, body ache, no fever, nausea, heart palpitations, feeling that my blood is on fire, mild sore arm By 6-8 pm I was vomiting a lot and also going to the bathroom loose no diarrhea All night I felt sick and had raising thoughts in my mind. I have sensitivity to noises as well. On 4/8 I woke up very sick. Kept throwing up water and liquids. Couldn?t eat. By 1 pm I have thrown up some more The raising thoughts and things in my mind bother me 3 pm my veins in the back of my knees are hurting I have the feeling that I can feel my kidneys, liver, intestines Took Tylenol 9 pm and still feeling sick 4/9 still nauseous and with a pounding headache Took Tylenol By 8 pm I?m feeling a bit better
53 2021-04-09 weakness 12 hours after vaccine, started with headache and dizziness, pain in knee , the tooth pain and jaw p... Read more
12 hours after vaccine, started with headache and dizziness, pain in knee , the tooth pain and jaw pain. few hours later sharp pain in bones, fever and chills added around 18 hours post vaccine, around 20 hours after vaccine I had a pulse of 118 feeling palpitation, flue like muscle achiness and weakness hit at night. I took Tylenol for it. the next day the lymph node in my arm pit same side vaccination (left) was swollen painful , and tender to touch. 2 days later I had runny nose with headaches.
53 2021-04-09 pain in extremity Dose 1: Sore left arm the next morning for 24 hours then gone. Dose 2: Sore right arm early next mor... Read more
Dose 1: Sore left arm the next morning for 24 hours then gone. Dose 2: Sore right arm early next morning, slight headache then headache gone post Tylenol administration.
53 2021-04-10 feeling hot Extreme vertigo upon rising the next morning. Dizziness throughout the day. Fatigue, feeling hot.
53 2021-04-10 numbness LIGHTHEADED NOSE NUMB/TINGLING CAME ON QUICKLY WITHIN 5 MINUTES OF INJECTION, AND FADED SLOWLY, MOST... Read more
LIGHTHEADED NOSE NUMB/TINGLING CAME ON QUICKLY WITHIN 5 MINUTES OF INJECTION, AND FADED SLOWLY, MOSTLY GONE WITHIN ANOTHER 10 MINUTES NO SIGNS/SYMPTOMS AT 2 HOURS POST VACCINATION
53 2021-04-10 muscle spasms After receiving the vaccine in April 2 I had nothing more than a mild headache and slight fatigue fo... Read more
After receiving the vaccine in April 2 I had nothing more than a mild headache and slight fatigue for a day. Then on April 10 after being in menopause for 2 years I started bleeding again. I typically never got cramps and have been experiencing mild cramps throughout the day. I have not been ill in any other way. I do feel that the vaccine caused this and the reason I am reporting this information.
53 2021-04-10 nerve pain, muscle spasms, tremor Around 11 pm I started to shake uncontrollably. My calves and feet would cramp if I moved the sligh... Read more
Around 11 pm I started to shake uncontrollably. My calves and feet would cramp if I moved the slightest. I was unable to walk on my own. My feet would not work and I was very dizzy. In the bathroom I felt like I was going to either throw up, pass out or have diahreah. I layed on the bathroom floor until I was able to get up with my husbands help. At this point my temperature was 100.8. I was sick all the next day but was able to walk to the bathroom unaasisted. Although my lower legs and feet still hurt. With having CMT, it felt like nerve pain. I only took my temperature 3 times and the highest was 102.5. I took tylenol and one dose of ibuprofen. The second day, no fever and felt about 90% better.
53 2021-04-10 pain in extremity, weakness Pfizer-BioNTech COVID-19 Vaccine EUA First injection About 8 hours after injection, soreness in ar... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA First injection About 8 hours after injection, soreness in arm/hurt to raise arm. About 11 hours after injection, onset of extreme fatigue and headache. About 15 hours after injection, onset of extreme headache and nausea. About 24-26 hours after injection, nausea subsided. I noticed fever. Extreme fatigue and no energy continued. About 36-40 hours after injection, fever receded. About 48 hours after injection, I feel normal again. No arm pain. Very slight headache. Energy levels returned to normal.
53 2021-04-10 pain in extremity body and muscle aches; low grade fever; chills; fatigue; arm soreness
53 2021-04-10 tingling Client had a chief complaint of tingling on the same side as her vaccine administration. Client stat... Read more
Client had a chief complaint of tingling on the same side as her vaccine administration. Client stated that she began to feel tingling from the left side of her temple and down to her arm on her left side after waiting a few minutes in the observation area. Injection site was intact and denied pain. Vitals signs were taken, water was given and Oral Benadryl 50mg was given to patient and an additional 30mins of observation were observed. After waiting in observation patient stated the tingling had gone away and felt better. emergency Precautions were given and to contact primary Dr in 24 hrs for follow up. Patient left location in no distress with her husband.
53 2021-04-11 discomfort I had a headache - which became severe and lasted about 8 days. That started on day two. It worsened... Read more
I had a headache - which became severe and lasted about 8 days. That started on day two. It worsened each day - by day four it was pretty bad. About day 2 and 3, I felt a little sick in my chest - a little wheezy and breathing mildly labored. Pain and discomfort in my neck (like my lymph). I had some fatigue on day 3 to day 7. The day before I sought care I broke out in canker sores in multiple places in my mouth and that's when I sought care because I work by talking. I got that care on Day 5. I have had canker sores before but never had an outbreak like this before. On my tongue, cheeks, lower lip and one up between the gums and the cheek up on my left back - all over. I called them canker sores but the doctor called them something else - not sure what that was. Related to a Herpes Simplex. San Cyclovir - 1200 mg single dose. Triamcinolone oral paste. Those helped with the symptoms. Three or 4 days after seeing her, the symptoms were resolving and by 5th day after they were pretty much gone. The headache resolved around day 10 after vaccine. Fatigue resolved around day 8.
53 2021-04-11 migraine Increased severity of migraine following Pfizer shot #1. Dramatically increased severity of migraine... Read more
Increased severity of migraine following Pfizer shot #1. Dramatically increased severity of migraine pain and nausea following Pfizer shot #2 (beginning April 7). Severe migraine pain still persisting as of April 12. Usual medications are not managing pain adequately.
53 2021-04-11 pain in extremity Major headache, sore arm, chills, tiredness
53 2021-04-11 pain in extremity April 8 and 9: sore arm April 10: headache April 11: headache and fatigue April 12: headache, fati... Read more
April 8 and 9: sore arm April 10: headache April 11: headache and fatigue April 12: headache, fatigue, chills, sore neck and 100.4 fever
53 2021-04-11 pain in extremity starting 30-45 minutes after injection, my right eye started twitching. By evening, I had mild flu ... Read more
starting 30-45 minutes after injection, my right eye started twitching. By evening, I had mild flu symptoms and a sore arm that lasted for 24 hrs. One week later, my eye is still twitching numerous times daily and I am getting off and on headaches.
53 2021-04-12 weakness fast heartbeat (over 100) on iwatch since the shot and fever (101.7 F), short of breath, Diziness an... Read more
fast heartbeat (over 100) on iwatch since the shot and fever (101.7 F), short of breath, Diziness and weakness
53 2021-04-12 weakness 04/09/21 @ 5:30 pm: sore throat, congestion / 7:30 pm: fever, chills, body aches, headache, dry cou... Read more
04/09/21 @ 5:30 pm: sore throat, congestion / 7:30 pm: fever, chills, body aches, headache, dry cough added. Temp was 99 04/10/21: All of the above plus no energy at all, nausea, and a mucus cough. It was an effort to get out of bed to use the bathroom. Temp was anywhere from 101 to 103 throughout the day. Wheezing and shortness of breath started about 10 am and I had to use the inhaler more than once. 04/11/21: Same as 04/10/11. Temp was between 100 and 102 04/12/21: Dry cough, low grade fever, headache, body chills, lethargic. Covid test taken. 04/13/21: Dry cough, headache, sore throat, shortness of breath, lethargic. Inhaler still being used.
53 2021-04-12 hot flush, night sweats, feeling hot Kept getting hot/sweaty then chilled the day after the shot. I started with night sweats the 2nd ni... Read more
Kept getting hot/sweaty then chilled the day after the shot. I started with night sweats the 2nd night. I have continued to have multiple "hot flashes" EVERY day and night since my first Covid vaccine shot. They start with a warm firey sensation in my torso then spread out from there. I never experienced these symptoms prior to March 14. It seems similar to hot flashes described for menopause but I had not hit menopause yet.
53 2021-04-12 numbness swollen lymph nodes under the left armpit and into the left breast area, radiating pain and discomfo... Read more
swollen lymph nodes under the left armpit and into the left breast area, radiating pain and discomfort that has persisted since onset, some numbness in the left arm.
53 2021-04-12 muscle twitching Dizziness and twitching and felt head heavy. Patient reports this happen after last vaccination for ... Read more
Dizziness and twitching and felt head heavy. Patient reports this happen after last vaccination for Pfizer.
53 2021-04-12 pain in extremity, weakness, tingling fever day of and day after vaccine, with sore arm and generalized fatigue. Fatigue became more inten... Read more
fever day of and day after vaccine, with sore arm and generalized fatigue. Fatigue became more intense during the first weekend and continued with times of tingling in extremities and feeling of very heavy arms and legs. Palpitations started a few days later and severe heartburn 3 weeks later. After 3 weeks from 1st shot, generalized weakness is still present. Did not take the second shot out of fear it will get worse
53 2021-04-12 tremor Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/... Read more
Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/was very pale and noted shaking. EMT took BP which was high (I'm typically on lower end of average). Observed me for 45 minutes as BP came down to normal range and asked if wanted to go to hospital. Declined as had appointment later that day with my electrophysiologist at Hospital. As day went on, became increasingly tired and had bouts of uncontrollable shaking. Thought it would wear off so just went home to rest. On 3/31/21, BP was high again, tremors were getting worse, had leg weakness, double vision, brain fog, dropping things, loose stools, felt off. Went to Hospital and was admitted for 3 days. Neurloigst, Dr., said it was due to Covid vacccine and NOT to get the second shot, and the hospital internist agreed (MRI of brain and cervical spine showed no new lesions). Wanted todo heart procedure but they are not my private cardio group so checked myself out and went to Hospital the next day (admitted 4/3-4/5/21)
53 2021-04-12 tremor Nausea, sweating, shaking, felt like i was passing out Lasted maybe 10-20 min. Slowly went away
53 2021-04-13 migraine Tuesday Feb 9, 102 Fever, sweats , Migraine headache, Chills, Same symptom's10th 11th 12 Nausea, Vo... Read more
Tuesday Feb 9, 102 Fever, sweats , Migraine headache, Chills, Same symptom's10th 11th 12 Nausea, Vomiting Diarrhea , Went to ER. Symptoms continued for another week. Went to ER again Feb20, same got worse returned to ER, they performed MRI, found liver & spleen enlarged on February 23rd, was admitted for 5 days of fluids. Was advised that something had triggered CMV in my body. After eye exam they found CMV Retina, I am still being treated for this condition currently with Valganciclovir. Per Dr. I may have to take meds for 6 months. I was released from Hospital on Feb27th, I still had fevers over 100 and could not take tylenol or advil, I had to ice down my body for over a week fevers continued. They finally went away and I was able to return to work on March 5th with restrictions as I was not fully recovered
53 2021-04-13 tremor, burning sensation, muscle spasms, pain in extremity, tingling Beginning 4 hours after the injection I experienced flu-like symptoms; muscle aches and pains, feve... Read more
Beginning 4 hours after the injection I experienced flu-like symptoms; muscle aches and pains, fever (took Tylenol to control did not go over 100), brain fog, fatigue, abdominal pain and diarrhea. These symptoms lasted for 3 days. In addition, during that time I started to experience difficulty walking; stiffness in my legs, cramping, burning in my feet, toes, aches and pins and needles in my toes and hands and fingers, overall shaky, with poor balance. The fever, brain fog, fatigue, abdominal pain and diarrhea resolved by Day 4; however all of the other symptoms difficulty walking, stiffness, cramping, burning, pins and needles throughout my body remain. The pain level has been as high as a 9 on a scale of 1 to 10. The widespread pain continues all day and night. Prior to the vaccine I was cycling an hour a day and now I have difficulty walking in my house and performing daily tasks and have so much pain in my hands I'm having trouble with computer skills for my job.
53 2021-04-14 feeling hot Extreme dizziness - Threw up due to upset stomach. Extremely hot.
53 2021-04-14 pain in extremity 6 hours after shot. Arm became extremely sore. Very hard to move. About 8 hours after body started t... Read more
6 hours after shot. Arm became extremely sore. Very hard to move. About 8 hours after body started to become tired and achy. At 12 hours after started a fever. 102.5. Lasted through the night. Chills. Body aches. Took Motrin at 6am the next morning and Tylenol at 11am. Feeling better but achy
53 2021-04-14 pain in extremity had vaccination 3/30 in L arm. On 3/31 had headache and on 4/1 developed increased sensitivity in R ... Read more
had vaccination 3/30 in L arm. On 3/31 had headache and on 4/1 developed increased sensitivity in R arm. Started development of herpes zoster in R arm on 4/2/2021.
53 2021-04-14 tingling, pain in extremity, numbness Painful numbing, tingling and swelling in hands. Chest discomfort and shortness of breath. Swelli... Read more
Painful numbing, tingling and swelling in hands. Chest discomfort and shortness of breath. Swelling and breathing issues resolved within a few days. Numbing, tingling and pain in hands is slightly improved but ongoing.
53 2021-04-15 weakness Fever of 100.4 starting at 10:22am on 4/5/21 with body aches and chills. Used thermometer and app to... Read more
Fever of 100.4 starting at 10:22am on 4/5/21 with body aches and chills. Used thermometer and app to track. Took no Tylenol until 11:40am after my fever went up to 101.1. Fever continued between 100.2 and 100.4 until 8:10am on 4/6/21. Took Tylenol last at 5:00am on 4/6, went back to bed and the fever never returned. Felt fine just a little weak/tired the rest of that day.
53 2021-04-15 bell's palsy bells palsy
53 2021-04-15 breast pain After patient received the vaccine the following events occurred: - Office visit with PCP 4/14/2021... Read more
After patient received the vaccine the following events occurred: - Office visit with PCP 4/14/2021. Complaints consisted of chest pain, SOB, left shoulder and left breast soreness and pain, difficulty sleeping. CT and EKG test ordered and performed. - CT result showed bilateral Pulmonary Embolism. - Lower extremity doppler ultrasound was also performed and negative. Patient is still admitted to hospital and awaiting overall outcome.
53 2021-04-15 numbness, pain in extremity Client c/o sharp pain and numbness to the L/leg. Client seen and assessed by EMT and VS are: BP 177... Read more
Client c/o sharp pain and numbness to the L/leg. Client seen and assessed by EMT and VS are: BP 177/95, HR 84, O2 99%. Client denies any chronic condition and voiced that she had reaction to the first dose and reported symptoms to her Dr. Client advised to contact pcp and inform Dr. of today's VS as well as reaction. Client voiced understanding and cleared by EMT to leave.
53 2021-04-15 numbness Dizziness after 10 minutes lasting a few minutes, on the way home after 30 minutes wait experienced ... Read more
Dizziness after 10 minutes lasting a few minutes, on the way home after 30 minutes wait experienced lips became numb, dizziness, diarrhea and metal taste. A few days later on 7/10 nose and roof of mouth became numb and didn?t feel well. On 7/14 experience numbness in face and roof of mouth, dizziness and head ache
53 2021-04-15 pain in extremity Extreme shoulder pain immediately upon receiving shot. Arm became sore and unable to move or lift a... Read more
Extreme shoulder pain immediately upon receiving shot. Arm became sore and unable to move or lift arm. I have extreme muscle pain around the shoulder. Mobility of the are is very limited and constantly aches. It is hard to sleep. I am about 7 weeks out from receiving the shot and my arm is still injured. I was prescribed Meloxicam 15MG after visiting doctor on March 11, 2021. I was told I have shoulder tendonitis.
53 2021-04-15 seizure, mild one side paralysis received her 2nd dose of Pfizer on 4/8@8:32am, was given discharge information, education and direct... Read more
received her 2nd dose of Pfizer on 4/8@8:32am, was given discharge information, education and directed to our monitoring area. About 8:40am the clinic RN, went to assess the patient as she began to feel nauseated, began dry heaving without vomiting, had generalized redness, then complained of feeling light headed. She passed out so the RN eased her to the floor. A Rapid Response(RR) was called and the patient was moved to the stretcher. VS were taken and at about 8:50am the RR team arrived and assumed care. Once they arrived the patient began to seize. She was taken to the ER where she had another seizure. She remained in a post-ictal state for most of her stay at our facility.
53 2021-04-15 tenderness, migraine Area in left armpit started to feel sore about 24 hours after the vaccination. Armpit area swollen, ... Read more
Area in left armpit started to feel sore about 24 hours after the vaccination. Armpit area swollen, and tender to the touch morning of April 16, 2021. Tenderness has extended out of the armpit area and up towards collarbone as has swelling. Afternoon of April 16, 2021. Onset of migraine like headache around 1 PM on April 16, 2021. Headache feels worse when sitting down..
53 2021-04-16 numbness, muscle twitching, tingling numbness/tingling in hands and feet specs in urine Water feeling in the left ear nervousness feeling... Read more
numbness/tingling in hands and feet specs in urine Water feeling in the left ear nervousness feeling in my body like jitters and I can see some twitching Back, abdominal, and right side pain insomnia heartburn slight fever for one day Blood pressure elevated and slightly lower lip soreness diarrhea
53 2021-04-16 tingling scalp started burning; scalp started burning and tingling; actively balding; This is a spontaneous r... Read more
scalp started burning; scalp started burning and tingling; actively balding; This is a spontaneous report from a contactable Nurse (reporting on herself).This 53-year-old female patient received second dose of BNT162B2 (Pfizer COVID vaccine, Lot number EN5318) on right arm at a single dose via an unspecified route of administration on 03Feb2021 at 02:30 PM for Covid-19 immunization. Medical history included diabetes, hypertension, hypothyroid and obesity. Concomitant medications included Acyclovir, Atorvastatin, Amlodipine and Levothyroxine. She was known to be allergic to Sulfa drugs. The patient previously took first dose of BNT162B2 (Pfizer COVID vaccine, Lot number EK4176) at left arm at a single dose via an unspecified route of administration on 3Jan2021 02:30 PM, for Covid-19 immunization. The patient did not receive any other vaccine in four weeks. Since the vaccination, the patient had not been tested for COVID-19. After the first dose, she noticed that her hair was thinning. On 05Feb2021 (beginning approximately 50 hours after the second dose), her scalp started burning and tingling and she felt actively balding. It was unknown at that time if the damage would be permanent. The patient did not receive any treatment for the events. It was stated that she was not tested for COVID post vaccination. The outcome of the events of scalp burning and tingling and actively balding was not recovered. No further information was available.
53 2021-04-16 tenderness 21 hours after 2nd shot developed tenderness, swelling and pain left armpit area possible interpecti... Read more
21 hours after 2nd shot developed tenderness, swelling and pain left armpit area possible interpectional nodes. Also experiencing nausea.
53 2021-04-17 inability to speak High blood pressure: 134 Sys, 119 Dia, 86 Pulse; Tachycardia; Headache; Severe dizziness; Difficulty... Read more
High blood pressure: 134 Sys, 119 Dia, 86 Pulse; Tachycardia; Headache; Severe dizziness; Difficulty talking and being able to express oneself; Fever; Muscular pain; Allergy and redness to left arm and chest; Swollen glands
53 2021-04-17 burning sensation constipation; Severe lower right side pain, felt like burning and stabbing, thought my appendix was ... Read more
constipation; Severe lower right side pain, felt like burning and stabbing, thought my appendix was rupturing; felt like burning and stabbing; appendix was rupturing; This is a spontaneous report from a contactable consumer (reported for herself). A 53-year-old female non pregnant received second dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number ER2613, expiry date: unknown) via an unspecified route of administration at left arm at a single dose on 19MAR2021, for covid-19 immunization. Medical history included Gastrooesophageal reflux disease, diverticulitis, Graves Disease in left eye, full hysterectomy, high bp, high cholesterol, depression, hypothyroidism, Gastric bypass and heart ablation. Concomitant medications included an unspecified 5 different medications and daily vitamins. Historical vaccine includes first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number EN6203, expiry date: unknown) via an unspecified route of administration at left arm at a single dose on 25FEB2021 06:00 PM, for covid-19 immunization. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19. Neither was she tested for it since the vaccination. On 24Mar2021 19.00, she experienced severe lower right sided pain, felt like burning and stabbing, thought her appendix was rupturing. On an unknown date, she went to an emergency room (ER), had a computerized tomography scan that showed constipation. Her pain was at a level 9, was doubled over for 6 hours while seeking care. She had complete sudden onset of pain, with no warning. She was treated with Fentanyl shot that took almost an hour to provide minimal pain relief. Had continuing pain for three days after the initial onset. No real treatment other than pain medication were given at ER. She was told to get collace and mirilax. The outcome of the events of severe lower right sided pain, felt like burning and stabbing, thought her appendix was rupturing was recovering. No follow-up attempts are needed. No further information is expected.
53 2021-04-17 muscle spasms, pain in extremity I experienced very painful leg cramping in my right leg about two days after my vaccination. The pa... Read more
I experienced very painful leg cramping in my right leg about two days after my vaccination. The pain was persistent especially when i sat or laid down. It eased up after about 3-4 days but I am still experiencing pain in my right leg. I don't usually experience this type of pain which is why i am reporting it.
53 2021-04-17 pain in extremity Exhaustion, dizziness, nauseous, pain in legs and chest, sore throat, loss of appetite
53 2021-04-17 pain in extremity Received the injection on 4/7 at the top of my shoulder. It felt odd going in this time. Arm was fa... Read more
Received the injection on 4/7 at the top of my shoulder. It felt odd going in this time. Arm was fairly normal, just a little sore. At around 4:30 pm that same day, could not lift arm straight out, to the side, or back. The ache starts at top of my shoulder and runs down the inside of my arm. It is a significant ache that gets worse with movement. When at rest, it also aches but not as bad as when I move it. It hasn't gotten better and it had been almost 2 weeks. When at rest,
53 2021-04-17 pain in extremity During night after dose 2 I woke up with my left elbow aching. All of the following day I could not ... Read more
During night after dose 2 I woke up with my left elbow aching. All of the following day I could not lift anything heavy with that arm and have other joint pain in hands/fingers. It was intense until about 30 hours after injection then by next morning it was not as bad. It is not bad now but still certain movements still send a nerve pain into my left elbow and some days my fingers ache and it has been 4 weeks since 2nd vaccine. It is not unbearable but some days are more painful than others. It is almost like a stiffness in my joints (left elbow and knuckles on both hands).
53 2021-04-17 pain in extremity After second dose of Pfizer vaccine, after 5-6 hours had sore arm, then after mid night had chills a... Read more
After second dose of Pfizer vaccine, after 5-6 hours had sore arm, then after mid night had chills and fever for around a day. The following day, felt tired. After 2 days started feeling normal but having pain especially on the left side of the lower part of head. After 5-6 days, noticed bruise like marks on the upper left arm ( on 9 different locations) that received the vaccine.
53 2021-04-17 tingling, muscle spasms the contractions and cramping sensation went trough out her entire chest region and her back (like h... Read more
the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms); the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms; in the left arm it was cold and tingling; in the left arm it was cold and tingling; experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours; diarrhea on the weekend; strong cramps in her stomach (stomach flu-like symptoms); This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration in Arm Left on 23Mar2021 (Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included ischemic colitis in the past and she thinks that maybe the cramping started triggering it again. The patient's concomitant medications were not reported. On 02Apr2021 strong cramps in her stomach (stomach flu-like symptoms) and on an unspecified date, the patient experienced the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms), in the left arm it was cold and tingling (vaccination site coldness), (paraesthesia), experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours (muscle spasms) and diarrhoea on the weekend. Her second dose is scheduled on 13Apr2021, she would like to know if there are recommendations for her second dose because she heard that with the second dose the side effects are worse, she would like to know if someone else has reported these symptoms. She would like to know if she should possibly receive the vaccine in her thigh instead of her arm and if that would be helpful. The outcome of the events diarrhoea was recovered on 05Apr2020 and outcome of contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms) was not recovered and rest of the events was unknown. Information on the Lot/Batch number has been requested
53 2021-04-17 tremor passed out; chills; fever; headache; tiredness; Shakes; This is a spontaneous report from a contacta... Read more
passed out; chills; fever; headache; tiredness; Shakes; This is a spontaneous report from a contactable consumer reporting for self. A 53-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:00 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient received the first dose, administered in Arm Left on 08Mar2021 09:45 (Batch/Lot Number: EN6205). The patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; vitamin d3 taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported; iron taken for an unspecified indication, start and stop date were not reported. The patient experienced passed out, chills, shakes, fever, headache, tiredness 30Mar2021 08:30. Outcome of events was recovering. Follow-up attempts are needed. Information on lot/Batch number was obtained.
53 2021-04-18 numbness, tingling, sensory loss Ring and pinky finger on left hand have been numb/tingling since I woke up on morning of April 4th w... Read more
Ring and pinky finger on left hand have been numb/tingling since I woke up on morning of April 4th with decreased feeling .
53 2021-04-18 pain in extremity, burning sensation, breast pain, tingling, cold extremities, nerve pain Extreme fatigue. Inflamed muscle, nerve pain, from fingers to shoulder blade, including pain in neck... Read more
Extreme fatigue. Inflamed muscle, nerve pain, from fingers to shoulder blade, including pain in neck, right side of chest and breast, right armpit, arm, hand, finger, shoulder and shoulder blade, tingling in right fingers, fingers and hand extremely cold, sometimes burning sensation up and down arm, right arm range of motion is not high, grip is very weak, arm is very weak. Treatment: taking Ibuprofen.
53 2021-04-18 pain in extremity, burning sensation, numbness Arm Pain (first vaccine on April 3rd on right arm, pain began on rt side arm about 2-3 days after wo... Read more
Arm Pain (first vaccine on April 3rd on right arm, pain began on rt side arm about 2-3 days after words, fingers get numb when holding phone, gets especially bad when laying down and going to bed, shooting burning and numbing pain, rt hand and arm are weak)
53 2021-04-18 pain in extremity, tenderness My left arm is very sore with a 2 inch diameter blotch on it. The blotch is red and raised. When I t... Read more
My left arm is very sore with a 2 inch diameter blotch on it. The blotch is red and raised. When I touch it, it is sore to the touch.
53 2021-04-18 pain in extremity My arm was extremely sore and you could feel the knot in it. I went to work out at the gym a few day... Read more
My arm was extremely sore and you could feel the knot in it. I went to work out at the gym a few days after the shot and accidently hit my arm exactly where the shot was given on a door coat hanger. I almost fainted. I was in severe pain for days and the muscle in my arm has still not recovered. Its still sore three months later.
53 2021-04-18 pain in extremity A little over 24hrs after my 2nd shot I just started to hurt all over. My left arm had been sore, bu... Read more
A little over 24hrs after my 2nd shot I just started to hurt all over. My left arm had been sore, but that is normal with most vaccines. This was the "my everything hurts" . It did not matter if I was moving or sitting still. Also, my normal body temp was up 1 degree. This started around 6pm the day after the shot. I went to bed around 11pm, and had a glass of chocolate milk, as that helps with sore muscles after a hard workout. I awoke around 4am in a sweat. My temp was down, and the all over hurt was gone.
53 2021-04-18 tingling, pain in extremity Same day - some slight dizziness, and slight headache with sore right arm within 1 hour Same day - s... Read more
Same day - some slight dizziness, and slight headache with sore right arm within 1 hour Same day - sharp tingling pain in neck 2nd day - sharp legs, and right fore finger, still sore left arm (injection site) 3rd day - continual pin needle pain in legs, muscle aches, and joint pain, no longer pain in left arm of injection site 4th day - over-the-counter "Aleve" taken to treat muscle aches and join pain, still need points pain in: calves, finger and neck 5th day - racing heart symptom (never had before), along with same nerve tingles in calves, finger, neck and now through-out back 6th day - miler symptoms
53 2021-04-18 seizure Unconscious; Stood up and became very dizzy; Fell to the floor; Legs and arms were seizing; Legs and... Read more
Unconscious; Stood up and became very dizzy; Fell to the floor; Legs and arms were seizing; Legs and arms were seizing; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0150), via an unspecified route of administration, on 02Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history included seizures (but they are rare). The patient had unspecified concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 03Apr2021 at 10:30 AM, the patient stood up and became very dizzy, she fell to the floor and was unconscious. When she came to a few moments after (unknown time), her legs and arms were seizing. The patient did have a history with seizures, but they are rare. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
53 2021-04-18 unresponsive to stimuli, seizure 53yo female with a Hx of migraines/seizures/normal pressure hydrocephalus received her second dose o... Read more
53yo female with a Hx of migraines/seizures/normal pressure hydrocephalus received her second dose of COVID-19 vaccine 04/08/2021. 10 minutes after vaccination she started feeling nauseated and then doesn't remember what happened next. Was transported "unresponsive" to ER. CT MRI negative. Upon lab exam it was noted that her platelets had dropped from 245K to 86K. Received dose of epinephrine/solumedrol, pepcid. Diagnosed with having a seizure and thrombocytopenia. The next day her platelets had recovered to normal. Patient recovered and was discharged.
53 2021-04-18 unresponsive to stimuli About 8 minute after injection patient begin to get dizzy and become unresponsive for about 2 minute... Read more
About 8 minute after injection patient begin to get dizzy and become unresponsive for about 2 minute, her blood pressure was taken and was 80/90 EMS arrived about 417pm by then she was sitting up and responding to command
53 2021-04-19 weakness, numbness Stroke from a blood clot that went to the left side of my brain causing the right side of my body to... Read more
Stroke from a blood clot that went to the left side of my brain causing the right side of my body to be numb , weak and to lose a range of motion. Event date: 3/24/2021; hospitalized 3/24/21, 3/25/21, and 3/26/21.
53 2021-04-19 weakness About 39/40 hours after shot, I developed all the pre-menstrual symptoms that I would get in my teen... Read more
About 39/40 hours after shot, I developed all the pre-menstrual symptoms that I would get in my teens and twenties (bad cramps in front and back; big (half of my nose big), painful cyst/zit on face; grumpy mood; blah energy), and then 1-2 hours later I started a period like I would get in my teens and twenties (very heavy and very red). Still going after 5 days though finally slowing. Never heavy enough that I was worried, but I have not had a period like this in a couple of decades. And I have been peri-menopausal for 2 years now -- get my period very infrequently and sometimes its very light, sometimes its heavy. But I never get cramps any more. I don't get "PMS" grumpy-moody crap any more. It is never "red" any more. And it never starts in a rush like this one did any more (even when it is heavy). And it usually peters out after 3 days -- hasn't lasted 5 days in years and years.
53 2021-04-19 bell's palsy Left Bell's Palsy diagnosed by me on 04/19/2021. Symptoms began 4/17/2021.
53 2021-04-19 difficulty speaking Starting about 20 minutes after shot (after I left vaccination site), I experienced some throat and ... Read more
Starting about 20 minutes after shot (after I left vaccination site), I experienced some throat and lung tightening, hoarseness, racing heart, stomach cramping (symptoms similar to what I experience when I accidentally ingest a small amount of peanuts, except it didn't affect my mouth.) Symptoms did not worsen and I took 2 OTC Benadryl at about 40 minutes after shot upon arriving home (and alerted another adult at home that I was having a mild reaction). Allergic symptoms subsided about 60-75 minutes after shot. I discussed allergic reaction with my PCP at a previously scheduled appointment on 4/6/21, but did not seek medical attention.
53 2021-04-19 facial paralysis Rash on side of head occular droop shingles - herpes zoster shingles
53 2021-04-19 numbness, tingling Patient complains of dizziness and was brought to medical tent. Offered water and rest , elevated le... Read more
Patient complains of dizziness and was brought to medical tent. Offered water and rest , elevated legs. Pt then c/o of numbness and tingling to left side of face. Benadryl 25mg was given @ 11:53AM. PT was stable and symptoms continued to progressively increase. More numbness, tingling extending to entire face, lips, and neck. Able to speak in full sentences, lips appear slightly edematous. Given a second dose of Benadryl. VS stable. Pt left with EMS at 12:15
53 2021-04-19 muscle spasms Almost immediately, experienced lower abdominal cramping (felt like menstrual). That evening, expe... Read more
Almost immediately, experienced lower abdominal cramping (felt like menstrual). That evening, experienced (for the first time) severe leg cramps in both legs where multiple muscles cramped in each leg from groin to foot. This happened repeated throughout the night and continued for approximately 14 days. After second dose, cramping in right shoulder blade and both legs occured. Now have a spotted, blotchy, purple (no itchy, just pigmented) large rash on both interior thighs and knees, and partial right calf. Leg cramps continue during the night, only.
53 2021-04-19 pain in extremity, weakness Left arm could not touch between shoulder and elbow without severe pain and the 5th day uncotraollab... Read more
Left arm could not touch between shoulder and elbow without severe pain and the 5th day uncotraollable runs, fatigue and weakness
53 2021-04-19 pain in extremity, feeling hot She got the vaccine, within the first night she woke up around 9:00 to 10:00 as she felt more fatigu... Read more
She got the vaccine, within the first night she woke up around 9:00 to 10:00 as she felt more fatigued. She had pulsing ringing (already has tinnitus), really loud ringing. Her skin was really hot (sunburn hot), tongue was sore, her eyes hurt (tissue burning sensation) feeling. Heft left arm was extremely painful, but went away. The headache all through the front, part of her forehead, eyes, head, and took 2 Tylenol. About 3 days after that her right wrist started hurting, throbbing pain. She has never had any joint pains. She has been taking Turmeric, the right wrist is still hurting. She did have body aches, throat, and all symptoms, felt like she had a flue/cold. She is completely dizzy, disoriented and not able to use her phone. She is not able to regain her balance at this point. The lingering effects are she cannot read, she always feels like she has been lost in space. The pain is improving, but is still present. When she looks down the dizziness is a lot worse. She has pushed back the 2nd vaccine. She has called her doctor and reported this who told her to call us. She took Claritin and it stopped a lot of the symptoms.
53 2021-04-19 pain in extremity 30 minutes after getting the vaccine I started having unbearable pain on my legs, hands and arms, my... Read more
30 minutes after getting the vaccine I started having unbearable pain on my legs, hands and arms, my veins hurt and are swollen, some of my veins have erupted. I can't even sleep because of the pain
53 2021-04-19 pain in extremity Vaccine was administered subcutaneously hence an possible efficacy failure. Nurse painfully pinched... Read more
Vaccine was administered subcutaneously hence an possible efficacy failure. Nurse painfully pinched arm skin to administer COVID vaccine into pinched area. Second shot was administered 4/17 and sore arm was the only side effect (consistent with known effects expected of first shot). Am concerned I am at risk having essentially only received only one correctly administered shot. Note: "Injecting a vaccine into the layer of subcutaneous fat with poor vascularity resulting in slow mobilisation and processing of antigen leading to vaccine failure."
53 2021-04-19 tremor Stomach cramps, gastrointestinal issues, diarrhea, loss of appetite, lethargy, fatigue, occasional d... Read more
Stomach cramps, gastrointestinal issues, diarrhea, loss of appetite, lethargy, fatigue, occasional dizziness, brain fog, shakiness
53 2021-04-20 weakness 4/21/2021 Pt was observed post Covid-19 immunization for 15 minutes . During the observation peri... Read more
4/21/2021 Pt was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness, weakness and low blood sugar. Assessment : Time of assessment 113pm. Alert and oriented, Anxious and Diaphoretic. Actions taken: Vitals sign taken form obtained and completed by RN. VS at 113pm BP- 152/81, P- 68, O2- 98%. Recheck at 128pm, BP- 102/65, P- 69, O2- 100%, Recheck at 140pm, BP- 136/65, P- 68, O2- 100%. Juice given x 2, Fan place on patient to circulate air. Medications administered: none Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 1:10 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc
53 2021-04-20 weakness Having been in menopause for 3 years, no periods. I got a quick bad headache followed by weakness an... Read more
Having been in menopause for 3 years, no periods. I got a quick bad headache followed by weakness and spotting from vagina. Currently still spotting
53 2021-04-20 numbness, pain in extremity Pain at injection site that radiated to the hand. Pain turned into numbness and heaviness. Pain then... Read more
Pain at injection site that radiated to the hand. Pain turned into numbness and heaviness. Pain then radiated to the neck and forehead. Pain then traveled down the the left leg. Increased pain for headache. Vital signs stable. Symptoms onset 30 min post vaccination. Tylenol at 45 min post vaccination with no improvement. Patient was transported via ambulance to local hospital.
53 2021-04-20 tingling, difficulty speaking Patient reported itchiness and tingling in throat and lower extremities as well as hoarseness of voi... Read more
Patient reported itchiness and tingling in throat and lower extremities as well as hoarseness of voice. Reports that when she had an anaphylaxis reaction to shellfish it started the same way and progressed to occluded airway. Vitals were within normal limits and 911 was called for transport Hospital ED. Symptoms reported around 11:05, EMS arrived around 11:30 and patient transported around 11:40.
53 2021-04-20 seizure First time seizure. Postictal for 45 minutes. Iv. Ecg/12 lead. Bgl, Head CT, MRI, EEG. All negative.... Read more
First time seizure. Postictal for 45 minutes. Iv. Ecg/12 lead. Bgl, Head CT, MRI, EEG. All negative. Awaiting sleep study and M.S. appointment in May. Unknown cause at this time. My neurologist wanted me to report it.
53 2021-04-20 tremor Systemic: tachycardic and uncontrollable shaking-Medium, Systemic: Shakiness-Medium, Systemic: Tachy... Read more
Systemic: tachycardic and uncontrollable shaking-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: 30-35 min post injection...patient complained of feeling strange and her heart was pounding. Measured BP at 160/95 and P at 117. Had patient sit in armed chair and drink some water. Continued taking vitals every 5 minutes. At about 45 minutes post injection patient started shaking uncontrollably. About 15 minutes later vitals returned to normal range. Had patient sit for another 10-15 minutes then had her stand to check for orthostatic hypotension. Advised patient to contact PCP.
53 2021-04-21 feeling hot, tenderness, flushing Low grade fever and flushing to face and upper neck beginning around 5:30pm on Tuesday 20th of April... Read more
Low grade fever and flushing to face and upper neck beginning around 5:30pm on Tuesday 20th of April. 2 Ibuprofen taken orally. Temperature was normal when checked 45 minutes after taking ibuprofen. Pain, tenderness, and swelling of lymph node in Right armpit noticed approximately an hour after low grade fever. Lymph node became warm, quite swollen and painful with what seemed to be excess fluid around it. 2 Ibuprofen were taken at 11:30pm, no reducing in symptoms detected. Lymph node was still very swollen and painful the next morning so a warm compress was applied which provided a small amount of comfort but did not reduce swelling. By 11am on the 21st lymph node was so painful that I took 500mg Naproxen. Swelling of the lymph node reduced approximately an hour to hour and a half after taking Naproxen, but swelling was not entirely eliminated. Swelling of lymph node continues as of today, Thursday. Injection site pain, feeling 'bruised' as well as red and hard approx. size of nickel.
53 2021-04-21 feeling hot Patient was given 1st dose of Pfizer vaccine at 13:55. At 14:10 patient reported feeling warm and f... Read more
Patient was given 1st dose of Pfizer vaccine at 13:55. At 14:10 patient reported feeling warm and feels heart rate is increased. She reports that she takes blood pressure and anxiety medications. VS: 14:10 BP 140/90 SPO2 98% RR 20 Pulse 96 14:15 BP 138/92 SPO2 97% RR 20 Pulse 94 14:25 BP 144/88 SPO2 98% RR 20 Pulse 90 Patient drank water and used her inhaler independently. Feels her asthma has been flaring up. Also states mask makes her uncomfortable. 14:40 Patient stayed 45 minutes and "feels cooler". Discharged home without any issues.
53 2021-04-21 migraine Extreme tiredness - slept for hours, difficult to stay awake. I had a migraine on April 18th, but ... Read more
Extreme tiredness - slept for hours, difficult to stay awake. I had a migraine on April 18th, but did not take any medication for it. Woke up on Monday feeling good, but was exhausted that day (19th), and Tuesday (20th). Woke up with bad migraines on Tuesday and Wednesday mornings (April 20th and 21st).
53 2021-04-21 numbness and pain in extremities Neuropathy has been more intense.
53 2021-04-21 pain in extremity sore arm, headache, body ache, naseau, diarrhea, chills, congestion
53 2021-04-21 tremor Very bad Chills ans shaking first night. Nausea day 2 and 3. Normal on day 4. Severe diarhhea days 5... Read more
Very bad Chills ans shaking first night. Nausea day 2 and 3. Normal on day 4. Severe diarhhea days 5 and 6 along with all over body aches. Unable to eat due to nausea days 6-8, Day 7 severe nausea, body aches with uncontrollable shaking all night, Entire body of nerve in excruciating pain. Day 8 (today) Felt like I needed to go to the ER last night. Can't go to work. In bed all day with continued bouts of chills and shaking. Fever has been low grade or none during all this.
53 2021-04-22 weakness April 22, I started out the day with fatigue I noticed around 9am (the day after my 2nd shot). That ... Read more
April 22, I started out the day with fatigue I noticed around 9am (the day after my 2nd shot). That quickly progressed into chills. Then throughout the day progressed into constant extreme chills, body aches, swimmy head, dizziness, extreme weakness, headache and fever (100 degrees). Slight nausea toward the evening. I didn't take any medication for the symptoms. Went to sleep around 8:30pm and woke up around 7am April 23) feeling much better. Still slightly weak and tired but no other symptoms.
53 2021-04-22 numbness 53-year-old female patient presents emergency department with complaint of left-sided facial numbnes... Read more
53-year-old female patient presents emergency department with complaint of left-sided facial numbness and left arm numbness. Patient states that around bedtime last night at 2100 patient was watching television with her husband when she developed a headache and noted some left blurred vision. She states she also developed left facial swelling with mild redness and some sore in her mouth. She woke up at 0600 this morning with new symptoms of left face and left arm numbness. She reports the facial swelling, redness, and sores, as well as left eye blurred vision have improved some. The symptoms have not interferred with her ADL or prevent her from functioning. She denies history of stroke, HTN, TIA. She reports that she received her second Pfizer COVID-19 vaccination on 2/9/21 and developed the above mentioned symptoms within about 24 hours. hief complaint numbness left side of her face, blurry vision on left eye, numbness left arm, blisters on hard palate after Covid vaccine administration-symptoms improving, still have some numbness left side of her face Muscle strength equal on the right and left, no mouth droop, normal speech Assessment and plan Acute left facial and left arm paresthesias Left eye blurry vision Headache Covid 19 vaccine administration 3 days ago Questionable TIA History of ocular migraine Palpitation Neurochecks MRI of the brain Check TSH, iron studies, B12, folic acid level, magnesium, echocardiogram MRI - normal CT angio - normal echo - normal symptoms rapidly improved after 1 day in the hospital other than some lingering mild blurry vision. pt was discharged after 1 night in the hospital
53 2021-04-22 tingling patient felt palpitations and arm tingling, headache
53 2021-04-22 tingling Tingling sensation in neck and down the arm with the injection.
53 2021-04-23 numbness, tingling, pain in extremity About a week after vaccination, my left arm, which had the vacine, started throbbing up and down. I ... Read more
About a week after vaccination, my left arm, which had the vacine, started throbbing up and down. I was wondering if I was having a heart attack. It lasted a few days. A week or so later, that arm started hurting from back of shoulder down to my hand and my fingers are numb/tingling. It feels like my muscles are in pain in that left arm. It has not disappated.
53 2021-04-24 weakness, feeling cold, tremor rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating pr... Read more
rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating profusely; temp of 101; trembling uncontrollable; freezing; terrible headache; lethargic; This is a spontaneous report from a contactable consumer (who is also the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm, on 07Apr2021 10:30, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) received at age 53 years, via an unspecified route of administration in the left arm, on 16Mar2021 11:00, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 08Apr2021 at 03:30, the patient woke up trembling uncontrollable and was freezing. She had a terrible headache. At about 04:30, the patient got out of bed to get some Advil and go to the bathroom. She almost got to the bathroom but was unable to hold her urine and had sudden diarrhea as soon as she sat down. She then became extremely weak and passed out. She was sweating profusely and had a temp of 101. She took Tylenol and Advil and her temp broke an hour or two later. She then had a headache and was lethargic all day on 08Apr2021. On 09Apr2021, the patient felt much better but reported she was still weak, she also had a rash covering most of her torso. Treatment for the events trembling uncontrollable, freezing, terrible headache and temp of 101 included Tylenol and Advil. No treatment was taken for the remaining events. The outcome of extremely weak was not recovered; and the outcome of the remaining events was recovering.
53 2021-04-24 burning sensation 16 hours after receiving my 2nd Covid 19 vac shot, I woke up and my body felt like it was on fire, m... Read more
16 hours after receiving my 2nd Covid 19 vac shot, I woke up and my body felt like it was on fire, my eyes were burning and had a bad headache. I took 2 Advils and tried to fall back to sleep. Six hours later my fever and headache returned along with the chills and body aches. I took 2 more Advil and waited an hour and the headache went away. It took about a day and a half before before the side affects subsided.
53 2021-04-24 feeling cold Felt very tired and dizzy at 1 pm on the day after (4/22) the shot, fell asleep, woke up at around 4... Read more
Felt very tired and dizzy at 1 pm on the day after (4/22) the shot, fell asleep, woke up at around 4 pm with severe chills. Woke up at 3:30 am on 4/23 with a fever of 101.9. Took Advil. Fever was 100.6 in the morning. Had a splitting headache and severe body aches the entire day and night and took Advil as directed. On 4/24 I was still light-headed and fatigued but no fever. By the evening I felt much better. By 4/25 I was 100% back to normal. Thank you.
53 2021-04-24 feeling hot, flushing there is some sort of inflammation going on with that.; CPK test is strange; facial sagging, sagging... Read more
there is some sort of inflammation going on with that.; CPK test is strange; facial sagging, sagging eyelids went away/Neurological inflammation went away/Pain went away; flushing; Warmth; Low grade fever; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 10Apr2021 (Batch/Lot Number: EW0153) as SINGLE DOSE for covid-19 immunisation. Patient did not receive Other medications in two weeks of vaccination. Medical history included sjogren's syndrome from 2002 and ongoing. Patient stated dry eyes and dry mouth were part of this diagnosis and less lubricating fluid in joints which gets worse as you age. patient is not sure if her body destroying her peripheral nervous system is part of this syndrome, it is still idiopathic. Unknown if peripheral neuropathy is associated with this syndrome, raynaud's syndrome about 2002, give or take 1 or 2 years at the Medical Center, ongoing, postural orthostatic tachycardia syndrome (2002), patient feet would turn red, white and blue. In order to do nerve conduction studies, they have to put her hands and feet in warm water to bring up the temperature to get accurate results, ongoing, allergy Started since she was a child. Patient states she has allergies to about 40 different medications, anaphylactic reaction to Naprosyn sodium, allergic to Atarax. Levaquin is bad and Patient lost consciousness, had to have CT done to see if Patient suffered a concussion, her blood pressure plummeted, ongoing, hypermobility syndrome diagnosed about 2-3 years ago. This is also referred to as double jointedness and can also be looked at as a connective tissue disease. It has wide range of effects on the body, ongoing, arthritis unsure of what type, doctors are discussing rheumatoid, Peripheral Rheumatoid Arthritis. Has had for quite a while. Has had aches and pains for so long. Since Patient early 30's. Maybe 1998. Contractures showing up in her hands they are thinking it is some form of rheumatoid or other autoimmune arthritis, possibly osteo. It is becoming far more pronounced, ongoing. Seizure Verbatim: Nocturnal seizures Class 3, left temporal lobe where abnormal electrical activity was found. About 10 years ago, rapid eye movement sleep behaviour disorder from 2002 and ongoing. Rapid eye movement sleep behavior disorder Diagnosed in 2002. Patient acts out her dreams. Diagnosed from sleep study, ongoing. Thrombocytopenia Verbatim: Thrombocytopenia physician watching her for this since the beginning of 2021. Doctors are watching her platelets. Patient bruises easy and because patient is at the age her mother was diagnosed. Patient mother has a history of Thrombocytopenia. History of this disorder with the females on her mother's side, mother and grandmother. Could be a genetic variant, ongoing, hypothyroidism thyroid nodules crushed her thyroid. Diagnosed 5 years ago and has to take Synthroid, endometriosis Connective Tissue Disorder, abnormal cavity. Diagnosed about 6-7 years ago. Had a Hysterectomy. Doctors could not find one ovary and one fallopian tube. Its all over her intestines. Patient had allergies of Plaquenil, antihistamines and non-steroidal antinflammatories, urinary tract infection and patient had Flu shot vaccine and had a sore arm. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. After she received the covid vaccine on 10 Apr 2021, she felt warm for a change. She could feel her eyes opening up and noticed her hands, shoulder, back and joints do not hurt. There are some joints in her hands that have scar tissue with a bump, her hands were no longer red or purple and swelling started to recede. Hands are no longer swollen or red. Out of all the different treatments, this has never happened. She still does not have redness or swelling. She is scheduled for her second vaccine on 01May2021. Caller stated she has not started any new medication 2 weeks prior to the vaccine or any after the vaccine. She is on palliative care and there are medications that she takes on daily basis. She has been on the same doses. Reports she revamped her own medications in the past because she felt like she was being overmedicated. She got rid of a bunch of junk last year and somethings she added back in at a much lower dose. No further details provided. Blood tests don't catch everything since she is genetically predisposed to giving false negatives. If she is in a flare up, the c reactive protein test, in the past, it always came in normal and now it is documented there is some sort of inflammation going on with that. Her CPK test is strange, it is a test for destruction of muscle tissue, 600 is considered high and she has scored as high as 3000. A lot of stuff going on and it is hard to separate when technology and research is not there yet. Her symptoms are treated as they emerge. The patient's facial sagging, sagging eyelids went away/neurological inflammation went away/pain went away. The patient experienced flushing, warmth/low grade fever on 10Apr2021, there is some sort of inflammation going on with that on an unspecified. CPK test was strange on an unspecified date. Outcome of flushing and warmth/low grade fever was resolved, and outcome of all other events was unknown. No follow up attempts are possible, no further information is expected.
53 2021-04-24 feeling hot Patient had some difficulty with the 1st dose of this vaccine at a different location. She was very... Read more
Patient had some difficulty with the 1st dose of this vaccine at a different location. She was very nervous(highly anxious) about receiving the 2nd dose. She had a fair amount of pain on injection and on administering the vaccine. Quite unusual for 0.3ml dose. While waiting in area, she became very hot, thirsty, her husband got her some water, she was becoming very pale, I was clearing a spot in immunization room for her to lay down and elevate her legs to help with that, before I could get the location prepared, her husband noticed she was about to pass out. At that point she did pass out for a very short time, I prepared and administered a dose of 0.3mg EpiPen in the left outer thigh. I did this at approximately 01:33pm. All the events occurred very rapidly, she responded to the epi pen as far as her consiousness was concerned, then we called "911"! While waiting for the paramedics she began vomiting and continued that until they arrived and after they arrived. They administered a dose of andansetron and fluids IV. They then took her to the hospital for further treatment and observation,
53 2021-04-24 numbness Left side of face (cheek & along jaw) went numb/spread across to right side of my face then under ja... Read more
Left side of face (cheek & along jaw) went numb/spread across to right side of my face then under jaw and upper neck.; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EP6955) via an unspecified route of administration, administered in left arm on 09Apr2021 10:00 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 09-APR-2021 10:45 , the patient experienced left side of face (cheek & along jaw) went numb then spread across to right side of my face then under jaw and upper neck. Outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.
53 2021-04-24 migraine Heavy metallic taste x 1 week Low grade fever x 2 weeks Migraines x 2 weeks Sore throat x 2 weeks ... Read more
Heavy metallic taste x 1 week Low grade fever x 2 weeks Migraines x 2 weeks Sore throat x 2 weeks Bruise at injection site (vaccine administration was painless)
53 2021-04-24 migraine she began to feel like she was straining to take a deep breath. When she would take a deep breath (l... Read more
she began to feel like she was straining to take a deep breath. When she would take a deep breath (like a yawn), she would do her best to stifle it as her chest would experience an immense pain while inhaling deeply/diagnosed with pericarditis; fluid had accumulated around her heart; headache/migraine; patient's lymph nodes on neck were causing her discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 25Mar2021 10:45 (Batch/Lot Number: ER8730) as SINGLE DOSE for covid-19 immunization. Medical history included "Hypothyroid" (hypothyroidism) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took guaifenesin (MUCINEX) and experienced allergies. On 31Mar2021, the patient's lymph nodes on neck were causing her discomfort which continued throughout. Around 1:00 am on 03Apr2021, she began to have a very intense headache/migraine. She began a regimen of Tylenol (8/day) and Advil (6/day) to mitigate the pain. Although the pain would diminish when she took these over-the-counter medicines, the headache never went away. In the evening of Sunday, 04Apr2021, she began to feel like she was straining to take a deep breath. When she would take a deep breath (like a yawn), she would do her best to stifle it as her chest would experience an immense pain while inhaling deeply. On Monday, 05Apr2021, went to a Clinic as she was straining so hard to breath. After numerous tests, she was diagnosed with pericarditis and, because of this, fluid had accumulated around her heart which was drained in a procedure called pericardiocentesis. They initially drained 230 ml and then 74 additional ml from a drain they had placed. The patient was hospitalized due to the events. The patient underwent lab tests and procedures on 05Apr2021 which included Nasal Swab (sars-cov-2 test) with negative result. The outcome of events was reported as "recovering". The patient did not receive treatment for "patient's lymph nodes on neck were causing her discomfort" but received treatment for all of the other events. Follow-up attempts are completed. No further information is expected.
53 2021-04-24 night sweats 2 weeks after first shot started having terrible night sweats. The next morning I woke with vertigo ... Read more
2 weeks after first shot started having terrible night sweats. The next morning I woke with vertigo so bad I could hardly walk. Actually fell off the toilet reaching for paper. Also started noticing a ringing in my ears. Vertigo, dizziness and nausea lasted 5 days. As the vertigo finally subsided the tinnitus has gotten louder and louder. I have put off my second shot as I'm afraid it will make it worse.
53 2021-04-24 pain in extremity, numbness arm pain; numbness in her hand; This is an initial spontaneous report received from a contactable co... Read more
arm pain; numbness in her hand; This is an initial spontaneous report received from a contactable consumer (Patient). A 53-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not provided) first dose via an unspecified route of administration in arm on03Apr2021 as single dose for COVID-19 immunization. The patient medical history was reported. The patient concomitant medication was not reported. The patient experienced that she stated she has been having issues with her arm. She reported arm pain and numbness in her hand. She asked if this is a side effect? She stated she needs to know if it is from the vaccine or if it is potentially another medical problem. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.
53 2021-04-24 pain in extremity fever (100 Fahrenheit); chills; sore arm; head ache; fatigue; Vaginal bleeding; This is a spontaneou... Read more
fever (100 Fahrenheit); chills; sore arm; head ache; fatigue; Vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 09Apr2021 03:45 (at the age of 53-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (lot number ER2613) on 19Mar2021 at 05:45 PM, administered in left arm. Medical history included kidney stones, over weight, vaginal birth of three live children, tubal ligation, gestational diabetes and menopause. Patient had also allergy to cefzil. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient reported that she woke up at 08:00 on 10Apr2021 and at 08:30 she had sore arm, headache, fatigue, bleeding and chills recovered after rest. At 15:00 she had fever 100 Fahrenheit. Chills, fatigue and headache lasted until 20:00 dosed with acetaminophen and Ibuprofen. On 11Apr2021 at 08:00 bleeding continued. Patient stated that she has started menopause and she had only spotted during cycles, no significant bleeding in 6 months . This bleeding was significantly heavier. The events resulted in Doctor or other healthcare professional office/clinic visit. Vaginal bleeding was not resolved, the outcome of fever was unknown and the other events were resolved.
53 2021-04-24 pain in extremity Soar arm that had the vaccine, horrible aches through the whole body, heavy chest and a swollen lym... Read more
Soar arm that had the vaccine, horrible aches through the whole body, heavy chest and a swollen lymphoid in the arm pit of the injection. Also fatigued.
53 2021-04-24 pain in extremity Left arm hurt like hell for 3 days could not use it, raise it and throbbed from shoulder to elbow , ... Read more
Left arm hurt like hell for 3 days could not use it, raise it and throbbed from shoulder to elbow , couldn?t sleep without pain medication
53 2021-04-24 tenderness Breast engorgement, heavy and tender to the touch. Both breast. Feeling better today than this past... Read more
Breast engorgement, heavy and tender to the touch. Both breast. Feeling better today than this past week, but still sore.
53 2021-04-24 tenderness Patient states right side of her neck is swollen and tender and has progressively extended up to her... Read more
Patient states right side of her neck is swollen and tender and has progressively extended up to her right ear. Patient is an employee so brought patient to Store Director and they discussed options for seeing a doctor, sick leave, etc.
53 2021-04-25 burning sensation 6 hours after the second vaccine I experience typical symptoms of fever, fatigue and muscle aches. T... Read more
6 hours after the second vaccine I experience typical symptoms of fever, fatigue and muscle aches. Then 6 hours later I woke up with a swollen face, swollen eyes, welts, and hives. It burned and itched. I called the EMT and a doctor said I was not having an anaphylactic shock, but some sort of allergic reaction. He gave me a cortisone bill and proscribed an antihistamine. I took 50 mg. of cortisone for two days with 10mg. of an antihistamine. It subsided a bit, but at night, I swelled up again. Today I went to the doctor and got a cortisone infusion.
53 2021-04-25 numbness Patient was sitting in waiting room after shot when she experienced numbing on left side of face, fe... Read more
Patient was sitting in waiting room after shot when she experienced numbing on left side of face, feeling like a Novocaine shot at the dentist, this lasted for 7 hours. Patient came in thew next day to inform us of the event but did not have an other issues.
53 2021-04-25 pain in extremity I have weakness of the left arm where the shot was given. I have minimal range and pain if I try to ... Read more
I have weakness of the left arm where the shot was given. I have minimal range and pain if I try to move my arm. I cannot grasp any items nor can I hold any other position besides my side.
53 2021-04-26 weakness patient is reporting that the next morning after receiving her vaccine that she is experiencing seve... Read more
patient is reporting that the next morning after receiving her vaccine that she is experiencing severe dizziness, severe ringing in both ears, and that she can barely stand up. She said when she does try to walk that she only makes it a few step and then needs to hold on to something--she is very weak. This has been going on for 3 days now.
53 2021-04-26 involuntary muscle movements, muscle twitching Within 15 min of vaccine injection pt states "Its starting, and left arm starting twitching, pt bega... Read more
Within 15 min of vaccine injection pt states "Its starting, and left arm starting twitching, pt began rocking back and forth and then rest of body followed with 'involuntary movements' including her trunk and head. Pt states unable to control movements and body is in 'pain'. Pt transferred to emergency department - given Ativan and Benadryl and discharged home. Pt states this is not unusal for her post some medications.
53 2021-04-26 feeling cold Received the shot on Friday, 4/16/2021, between 10:15-1030 am.. Woke up feeling sick to my stomach, ... Read more
Received the shot on Friday, 4/16/2021, between 10:15-1030 am.. Woke up feeling sick to my stomach, Sunday morning, 4/18/2021, at 04:00 am.. Very nauseated. Threw up 7 times between Sunday and Tuesday, 4/20/2021. Had dry heaves when I couldn't throw up any more. I couldn't keep water down. Cold chills. Fever. First fever was 100, then 101 and 99. Very disoriented. Ate chicken broth and crackers threw that up on Tuesday, 4/20/2021. All I could do was lay in bed. Missed 2 days of work. Worked from home on Wednesday, 4/21/2021. Worked half day in office on Thursday, 4/22/2021 and Friday, 4/23/2021. On 4/24/2021, Saturday still had a little bit of nausea. My first day without nausea completely was yesterday, Monday, 4/26/2021. There was no treatment. I couldn't take my medication for 3 days because all I was doing was throwing up. Drank sips ginger ale, water and pedialite.
53 2021-04-26 feeling hot This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her... Read more
This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 11Apr2021 09:15 (Lot Number: EP7533; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 53 years). Medical history included asthma, Blood pressure high, acid reflux , allergies: Sulfa, Lactose intolerant and allergies: Latex. The patient's concomitant medications were not reported. The patient had a historical vaccine of Flu shot (INFLUENZA) on an unspecified date for immunisation and experienced bad side effects. The patient previously took bactrim, minocycline, doxycycline, ciprofloxacin, Moxifloxacin, demerol, avelox, nitrofurantoin, naprosyn, motrin, perocet, tramadol and aleve and experienced allergies. The patient experienced anaphylaxis on 11Apr2021. It was also reported that she had an appointment for COVID Vaccine at 9:15AM. Received COVID Vaccine and was told to wait for 30 minutes. Within 10 minutes her chest starting getting tight with difficulty of breathing. Her throat was closing up, and she was light headed. She explained this to the administrator who asked if caller could get up to see the paramedic. As caller tried to stand up, she almost passed out. Had to sit there for a second and the second time was able to get up and made it in to the room. Was going in and out of consciousness. Had to stab her with an Epi Pen. She couldn't breathe. Her throat was closing up. Her tongue was swollen. She was in and out of consciousness. First Epi Pen didn't work. An IV was put in and was given something through it. She was jabbed with a second Epi Pen. Was still in and out of consciousness but she was starting to come back. Was given oxygen and a nebulizer. She does have asthma. Ambulance was called. Was told she was worked on for 20 minutes. When ambulance arrived she was able to get up and get on the cart. She was taken to the hospital. Was given medicine through her IV. Had to be kept at hospital because she had two Epi Pens and medication at the vaccine facility. Hospital wanted to make sure when the Epi Pens wore off she didn't go back into anaphylaxis. Was kept in ER for over four hours. Was given IV fluids. Her oxygen, heart rate, and blood pressure dropped at vaccination facility. Oxygen was 81. Blood pressure was 94. At hospital, her levels started to get better. Once she was given the second Epi Pen and whatever else she was given, the medication started to work and she had come through. At the hospital, someone came in and did bloodwork for research to see why this happened. Was prescribed Epi Pens by the doctor in the hospital and was advised to carry Epi Pens with her at all times. If she has another anaphylaxis, was advised to jab herself with Epi Pen and call right away. Was told her tongue was swelling. Attempted to obtain the outcome of the anaphylaxis. At the hospital, she was so out of breath walking to the bathroom. Was told at hospital now she is having side effects from the COVID Vaccine including the tiredness and headache she is experiences. Was told to take Tylenol and Benadryl, lay down and rest, and to make sure she drinks so she does not get dehydrated. Today, she feels nauseous, lightheaded and tired with a little headache. She feels better from yesterday. Is getting better and is having a little chills maybe an hour ago. She checked her temperature and does not have a temperature, but her insides feel warm . The patient was hospitalized for the event anaphylaxis on an unspecified date. Therapeutic measures were taken as a result of was going in and out of consciousness. Events for anaphylaxis, consciousness fluctuating, chest discomfort. dyspnea, throat tightness, presyncope and swollen tongue occurred on 11Apr2021 while the remaining events occurred on an unspecified date. The patient underwent lab tests and procedures which included blood pressure: dropped and 94, blood work: unknown results, heart rate: dropped, oxygen saturation: 81 and dropped on an unspecified date. Therapeutic measures were taken as a result of all the events. Outcome of the events was unknown.
53 2021-04-26 numbness, tingling Patient stated that 2 days after her first shot, she experienced some weakness, numbness and tinglin... Read more
Patient stated that 2 days after her first shot, she experienced some weakness, numbness and tingling in her left leg. She did not let us know that she had this reaction until she came back to get her 2nd dose. She went to an urgent care thinking it was a pinched nerve. They gave her steroids, but she still has the issue and stated it was affecting her right-side some now as well. She limps a little bit and has some weakness. I reached out to Pfizer to see if they had any reports of numbness from their COVID vaccine. They stated they did not and could not provide any recommendations. On the chance this was related to the vaccine, I chose not to administer the 2nd dose.
53 2021-04-26 muscle spasms I have not had my period since February 2020. 24-48 hours after I received my first dose of Pfizer v... Read more
I have not had my period since February 2020. 24-48 hours after I received my first dose of Pfizer vaccine I started feeling cramps and PMS type symptoms. I thought it was stress related and disregarded. This morning I woke up to find I had started my period overnight. I've seen there have been reports of post-menopausal women bleeding after receiving vaccine.
53 2021-04-26 tingling, numbness Patient was ambulating to vehicle 15 minutes after vaccine and began with "pins & needles throughout... Read more
Patient was ambulating to vehicle 15 minutes after vaccine and began with "pins & needles throughout entire body", bilateral lower extremity inflammation, "complete left arm numbness". Patient returned inside and was provided a seat. No reported signs of difficulty breathing, no reported throat closure. No vital signs were taken. Patient was allowed to leave after she reported no feeling of "pins & needles"
53 2021-04-27 numbness First experienced lightheadedness and numbness in my arm and leg. This progressed to ringing in ears... Read more
First experienced lightheadedness and numbness in my arm and leg. This progressed to ringing in ears and severe imbalance. I have had continuing problems with lightheadedness, movement sensation and dizziness. I have also been very fatigued.
53 2021-04-27 migraine Patient reports developing a severe headache/migraine by the next day requiring a visit to the ED wh... Read more
Patient reports developing a severe headache/migraine by the next day requiring a visit to the ED which lasted greater than 72 hours.
53 2021-04-27 pain in extremity Fatigue, sore arm, generalized aches and pains x 3 days, (day 1-3 days post vaccine) chills, all day... Read more
Fatigue, sore arm, generalized aches and pains x 3 days, (day 1-3 days post vaccine) chills, all day x1 day (on day 2 after vaccine), nausea/vomiting x1 day (day 2 after vaccine)
53 2021-04-27 pain in extremity Received 2nd Pfizer COVID vaccine in right arm on 3/26/2021. One month/30 days later/ on 4/26, pati... Read more
Received 2nd Pfizer COVID vaccine in right arm on 3/26/2021. One month/30 days later/ on 4/26, patient awoke with a right arm rash - warm and red - similar to known "COVID VACCINE ARM" What was different is that she had a large blister in the middle of the large area of redness, pain and warmth. She was seen 4/26/2021 and Cephalexin was started. Follow up 2 days later - pt had improvement of the redness, but a new blisters were forming around the first blister. I will see her again in follow up in 5 days. She states she did not apply anything to the right arm after getting the vaccine.
53 2021-04-27 pain in extremity Patient received Pfizer COVID vaccine in L deltoid on 4/19/21 (unknown what facility she had it at) ... Read more
Patient received Pfizer COVID vaccine in L deltoid on 4/19/21 (unknown what facility she had it at) Reports the next day she felt great and her arm was just a little bit sore. The next day she had some minor joint aches. She started noticing a rash on 4/24/21, starting on her arm but quickly spreading all over her body. Has a hx of eczema and initially that it was but the rash was different as it was very itchy. Describes as being on entire body- attempted calamine and hydrocortisone lotion with some relief but did not reduce the rash. Also taking po benadryl BID. in Care department today 4/28/21 scattered Wheals, macules and papules to both upper extremities including palms and fingers, abdomen, back, neck, both lower extremities including toes, and scalp. Wheals appear to be spread evenly without any main concentration.
53 2021-04-28 feeling hot 1815: Fifteen minutes after injection given the patient felt, "hot, shaky, ears itching, swollen lip... Read more
1815: Fifteen minutes after injection given the patient felt, "hot, shaky, ears itching, swollen lips, itchy all over." She was given 100mg total of Benadryl. Patient AOx3 1830: Continues with increased heart rate, complaining of swollen tongue. Patient's personal Epi pen given and EMS called. Patient AOx3 1845: EMS arrived 1855: EMS departed for Emergency Room.
53 2021-04-29 cold sweat 4/20 diarrhea and nausea, loss of appetite; 4/21 cold sweats, fever, chills, fatigue, loss of appeti... Read more
4/20 diarrhea and nausea, loss of appetite; 4/21 cold sweats, fever, chills, fatigue, loss of appetite; 4/22-4/23 fatigue, intermittent fever, headaches; 4/24 cognitive difficulties, disorientation, highly susceptible to suggestions that were counter to self interest and needs, headache, fatigue
53 2021-04-29 nerve pain, pain in extremity, feeling cold Sore arm, Exhaustion, heaviness, freezing couldn?t get warm, joint pain, achy, nerve pain, swollen ... Read more
Sore arm, Exhaustion, heaviness, freezing couldn?t get warm, joint pain, achy, nerve pain, swollen limp node in right armpit, diarrhea and upset stomach. Got Covid Arm(rash at the site of shot) 6 days after first dose.
53 2021-04-30 pain in extremity Pain in legs that moved from calves to thighs to behind t he knee.
53 2021-04-30 pain in extremity swollen lymph nodes under her right arm; chills/Cold Chills; sore back/Back was hurting; sore arm/ar... Read more
swollen lymph nodes under her right arm; chills/Cold Chills; sore back/Back was hurting; sore arm/arm was sore and really hurting; This is a spontaneous report received from a contactable consumer(patient). A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Formulation: solution for injection, Lot Number: EW0161, Expiry date: unknown), via an unspecified route of administration on 10Apr2021 at 09:00, as single dose for covid-19 immunisation. The patient medical history included first dose of bnt162b2 (Lot number: ER2613) received on 20Mar2021. On 20Mar2021, the patient Arm hurt bad, like really achy. The event recovered on 22Mar2021. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Prior Vaccinations (within 4 weeks), Patient has had both doses of the Pfizer Covid Vaccine. On 11Apr2021, the patient experienced chills/cold chills, sore back/back was hurting, sore arm/arm was sore and really hurting, swollen lymph nodes under her right arm on 12Apr2021. She wanted to know if that was a side effect, what should she take, how long will that last, and is this normal. Caller clarifies that with the first one, her arm hurt bad, like achy. She never checked her lymph nodes then. The events were considered as non-serious. The outcome of the event was chills/cold chills reported as recovered on 12Apr2021 and other events were reported as recovering.
53 2021-04-30 pain in extremity Metallic taste; sore arm; This is a spontaneous report from a contactable consumer (patient). This 5... Read more
Metallic taste; sore arm; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EP7533) on 12Apr2021 05:45 PM in right arm at single dose for COVID-19 immunization. Medical history included epilepsy, bradycardia, hypothyroidism, trigeminal neuralgia, allergies to sulfa. Patient was not pregnant, not pregnant at the time of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. Concomitant medications within 2 weeks of vaccination included levothyroxine sodium (LEVOTHROID) and acetylsalicylic acid (ASPIRINE).The patient previously received levetiracetam (KEPPRA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced metallic taste and sore arm on 12Apr2021. No treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-04-30 tingling, numbness Client stated that during her 15-minute observation period, she experienced numbness and tingling in... Read more
Client stated that during her 15-minute observation period, she experienced numbness and tingling in her lips, which resolved within 4 minutes. She stated the sensation continued periodically for 2 days following the vaccine and lasted 3-4 minutes each time. She reported additional symptoms of headache for 2 days following first dose Pfizer COVID vaccine. 3 days following her first dose, her left middle finger became swollen, red, tingling and numb. She stated her left, middle finger issue resolved in 3 days.
53 2021-04-30 tingling, pain in extremity swollen joints; her back condition and may have "pinched a nerve or something; describes it as the w... Read more
swollen joints; her back condition and may have "pinched a nerve or something; describes it as the worst pain; the leg pain that she is experiencing and would like to know if it is possible that it could be related to a blood clot; leg pain; also has some tingling on the skin; It feels like a Charley's horse; had a horrible flu; Her every muscles and every joint hurt, and her head hurt; Fever; body aches; chills; joint pain; Her every muscles and every joint hurt, and her head hurt; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 07Apr2021 at 14:00 (Batch/Lot number was not unknown; Expiration Date: 31Jul2021), at age of 53 year-old, as 0.3 mL single, for Covid-19 immunisation. Medical history included liver disease from 2016 and ongoing. There were no concomitant medications. The patient previously took the first dose on 17Mar2021 for Covid-19 immunization and experienced fever. The patient received her second dose of the Pfizer BioNTech COVID-19 vaccine on 07Apr2021 and reports having side effects after. She is specifically worried about the leg pain that she is experiencing and would like to know if it is possible that it could be related to a blood clot and if she needs to be worried about it. She stated that with the "swollen joints" and everything from the vaccine, it is possible that it worsened her back condition and may have "pinched a nerve or something." She describes it as the worst pain she's ever felt in her life and states it "comes out of the blue" so she does not have time to prepare for it. She likens it to a "Charley horse" but a "really bad one" that goes away and has no pain afterwards. She states she is scheduled for an MRI next week of her lower back to investigate. The patient also mentions that she thinks she had COVID-19 at the time of her vaccine because "when I got the shot, I had a super strong response." On 07Apr2021, the patient had body aches, chills, she was on the couch for quite a while. The joint pain was incredible, even in her toes. She felt like she had a horrible flu. Her every muscles and every joint hurt, and her head hurt. She was on the couch for like 4 days. On day 3 or 4 she developed intermittent pain in the leg and shin on 08Apr2021. It feels like someone is drilling a jackhammer in it. It feels like a Charley's horse, but not, more like it's in the bone. She didn't associate it with the vaccine at first, even though she had never had this pain before until she got the vaccine. She said that she has had some back problems and scheduled a MRI to see if she had pinched nerve or something. On 08Apr2021, she also has some tingling on the skin. She read about side effects of blood clots and doesn't know if this leg pain could be related to a blood clot. She assumed it could be from her back. She read that with blood clots there is usually an ache and discoloration, which she does not have now. She also read that intermittent Charley's horse could have something to do with blood clots. She has pins and needles on the skin. She also had a headache after the vaccine, but she does not have it now. She said that the pain in her leg that shoots on and bangs in her tibia hurts when bending over, lifting her leg to her chest, squatting to pick up something, and going up and down the stairs. She said that the pain is horrible and it is worse than leg pain, it is worse than a charley horse, it is the worst pain she has ever felt in her life. She cannot stop screaming when it happens. States with the joint pain that she had, there may be a nerve that's being pressed on her back. She said that with all of the information being reported in the news about blood clots, she asked is that something she needs to be concerned about. She said that she did a virtual visit with her doctor and notified her of the leg pain and asked the doctor to schedule her for an MRI because of the pain. She stated her hemoglobin and hematocrit, MCV are high. She also said that the clotting is affecting her red blood cells. She ran a fever with the first vaccine, but she had a high fever between 103-104 degrees Fahrenheit after the second vaccine that stopped on 12Apr2021 or 13Apr2021. Her high fever lasted for about 3 days. She had a low grade fever that lasted for about a week. Her body aches resolved completely on 12Apr2021 or 13Apr2021. Her joint pain is in her back and elbows. She also had lot of joint pain in her shoulder and arm and radiates to her neck on the left side. She still has some muscle pain in her leg, but overall her muscle pain is gone. For treatment she used Ibuprofen 600 mg by mouth and fluids. The day before her shot, her son called and told her he tested positive for covid. She got a PCR test immediately on 07Apr2021 and the next day she was told it was negative. She thinks she might have tested too soon. She also says her response to it was so strong, she must have been getting covid and didn't know it. She might have tested negative because she had the first shot already. She wasn't worried about exposing others and went to get her second shot, but she got really sick after that and it kicked her butt pretty hard. The outcome of the events for leg pain and tingling on skin was not recovered, fever, body aches and headache recovered in Apr2021, chills on 11Apr2021, muscle hurt/pain on 12Apr2011, joint pain was recovering, and outcome of other events was unknown.
53 2021-05-01 bell's palsy I developed Bell?s Palsy just over 3 weeks after my 2nd dose of the vaccine. I don?t know if this w... Read more
I developed Bell?s Palsy just over 3 weeks after my 2nd dose of the vaccine. I don?t know if this was due to the vaccine because I know that Bell?s Palsy can come on for unknown reasons, but because of the proximity to the vaccine and the other questionable abnormalities that are being associated with the vaccine, my doctor thought it would be useful for me to report this.
53 2021-05-01 flushing, numbness Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadn... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: coughing-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Given 2 doses of benadryl at 810 pm and at 841 pm. used cold compress on back of neck and provided blanket for chills. Facility's medical team assisted. bp 160/90 spo2 98% hr 90 numbness was in legs have not been able to reach patient to see how she is doing (5/2/21). patient has anxiety disorder that seemed to worsen symptoms\r\n
53 2021-05-01 flushing Tachycardia, dizziness, flushing, sweating. BPs 163/64 (pulse 120-137), 148/73 (pulse 140-145). Sent... Read more
Tachycardia, dizziness, flushing, sweating. BPs 163/64 (pulse 120-137), 148/73 (pulse 140-145). Sent to Urgent Care for tachycardia.
53 2021-05-01 muscle spasms Severe myalgia, muscle cramp, headache, chills and fatigue. Progressively worse. Severe restrictio... Read more
Severe myalgia, muscle cramp, headache, chills and fatigue. Progressively worse. Severe restriction of rom in both arms. Right in particular. Unable to sleep 2/2 pain.
53 2021-05-01 tingling Consistent twitching in left eye - Starting immediately after2nd injection. Pressure in chest & tin... Read more
Consistent twitching in left eye - Starting immediately after2nd injection. Pressure in chest & tingling in both arms started about 5-6 days after 2nd injection.
53 2021-05-02 discomfort Dizziness, heaviness -- stress management education provided. Given water, drank 8 oz. Dizziness res... Read more
Dizziness, heaviness -- stress management education provided. Given water, drank 8 oz. Dizziness resolved, stable, released from vaccination site.
53 2021-05-02 feeling hot Left knee (side of injection site) felt hot. Similar to an MRI contrast. Not hot to the touch, but f... Read more
Left knee (side of injection site) felt hot. Similar to an MRI contrast. Not hot to the touch, but felt hot "inside". Lasted intermittently that day and the following 5 days. The "hotness moved from my knee to right above the knee. I started wearing compression socks on Saturday. Haven't felt the heat today (May 3, 2021).
53 2021-05-02 tingling 3 minutes after injection pins and needles from head to toe 5 minutes later tongue started to swell ... Read more
3 minutes after injection pins and needles from head to toe 5 minutes later tongue started to swell up. Lips and tingue were numb as if i had novacane. I went to nurses station ans was observed for 30 minutes. No change but symptoms did not get worse. Vitals were normal. Went to store took benedryl. 2 hours later still numbness of tongue. Went to ER at hospital and was seen by Doctor. Doctor said it was a side effect of the covid vaccine. I was released.
53 2021-05-02 seizure Headache, nausea, confusion, photophobia, seizure requiring a call to 911 and a visit the emergency ... Read more
Headache, nausea, confusion, photophobia, seizure requiring a call to 911 and a visit the emergency room.
53 2021-05-03 numbness, pain in extremity, tingling Left arm continues to be sore and achy after 2 weeks of the 2nd vaccine. Shoulder stiff and hurt wh... Read more
Left arm continues to be sore and achy after 2 weeks of the 2nd vaccine. Shoulder stiff and hurt when arm reaches forward or when bending forward. Neck stiff and achy. Left hand tingly and some numbness. Left arm week and left hand hurst when gripping. Expected to have sore arm after 2nd even 3rd day . 4th day after2nd vaccine shoulder became sore and achy. Arm continues to feel sore and even more difficult to move. Never had issues with shoulder arm neck or fingers before.
53 2021-05-03 migraine with aura I was sitting at my work computer and I experienced a vertigo sensation which lasted for 10 min. Ne... Read more
I was sitting at my work computer and I experienced a vertigo sensation which lasted for 10 min. Next, I had tunnel vision with a bright light where I couldn't read the words on my computer screen. This lasted for about 20 min. Next, I saw Kaleidoscopic vision on the sides of both of my eyes. This lasted for 1/2 hour more. It then turned into a headache. I have NEVER had anything like this in my life and went to the emergency room. They did a CT scan and found no abnormal findings. My blood pressure and all labs were normal. They stated it was "probably" a migraine with aura. It happened again 2 days later and again yesterday. I have an appointment to see my GP on 5/6/21. Again, this is not normal and has never happened before in my life.
53 2021-05-03 pain in extremity lost weight; tested Covid-19 Positive; Left arm sore; Sleepy; This is a spontaneous report from a co... Read more
lost weight; tested Covid-19 Positive; Left arm sore; Sleepy; This is a spontaneous report from a contactable consumer or other non-HCP. A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021), intramuscular, administered in Arm Left on 02Apr2021 01:00 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 02Apr2021 the patient experienced sleepy, headache. On 02Apr2021 15:00 the patient experienced left arm sore. On 02Apr2021 20:00 the patient experienced nauseous, achy, chills, fever. On 03Apr2021 the patient experienced fever started at 100 degrees. the highest fever was 101.8 and one time it went to 102 and never peaked at 102 again. On 03Apr2021 18:00 the patient experienced vomiting. On an unspecified date the patient experienced lost taste, smell, lost weight, tired. Upon follow-up received on 21Apr2021 the patient experienced tested covid-19 positive on 05Apr2021. She had the first dose on 02Apr2021, and tested positive for Coronavirus on Monday, 05Apr2021. She can't go for second dose until it has been 90 days. She is completely better and her taste, smell and all of that is back. She also received the antibody treatment infusion the following Tuesday. She stated she is a little chunky. She lost weight after getting the COVID, so that was a plus. She did not eat for about a week. She also experienced Arm pain, sleepiness, headache and fever. The fever kept increasing. Fever started at 100 degrees. The highest fever was 101.8 and one time it went to 102 and never peaked at 102 again. That was early in the morning hours 02:00 on 03Apr2021. She also had chills, and they did not stop until she got antibody infusion treatment and was in the hospital for that. It was outpatient. She does not have the name, dose, lot or expiration. She went to the hospital on Tuesday, 06Apr2021, around 2:30, and got one whole IV bag of Saline like water. They wait about an hour and they give you the other bag all through IV of that medicine. The monoclonal antibody is what she had. Wednesday, 07Apr2021 is the last day she had fever or chills. She was tired. She lost taste, smell and just started getting it back this week. When Saturday came, the fever was all day long. It was 100 to 101. Saturday night is when she started to throw up. The patient underwent lab tests and procedures which included covid-19: positive on 05Apr2021, pyrexia: high on 03Apr2021 The highest fever was 101.8 and one time it went to 102 and never peaked at 102 again. That was early in the morning hours 02:00 on 03 Apr 2021. Therapeutic measures were taken as a result of tested covid-19 positive, left arm sore, sleepy, fever started at 100 degrees. The highest fever was 101.8 and one time it went to 102 and never peaked at 102 again, nauseous, achy, vomiting, chills, lost taste, smell, lost weight, tired, fever. The outcome of event left arm sore,tested covid-19 positive was recovered. The outcome of event sleepy,fever started at 100 degrees. the highest fever was 101.8 and one time it went to 102 and never peaked at 102 again, nauseous, achy, vomiting, chills, fever was recovering. The outcome of event headache, lost taste, smell,lost weight, tired, was unknown. Follow-up (21Apr2021): New Information received from the contactable consumer includes updated events and dates, of lab data and questions regarding events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
53 2021-05-03 tingling, tension headache, inability to speak While waiting to leave, patient began "feeling head tightness, dizziness and tasting vaccine." She a... Read more
While waiting to leave, patient began "feeling head tightness, dizziness and tasting vaccine." She also stated that she had just received Botox to forehead and lips. Patient suddenly was unable to speak to due to expressive aphasia. Vital signs obtained and were 130/102, HR105 and SpO2 99% on room air. Patient is alert and oriented x3. Patient given gatorade and cool fan to face. When able to speak, patient started to complain of "tingling" to bilateral hands and arms. EMS notified and patient was escorted to front entrance via wheelchair. EMS arrived on scene at 0914 and care was transferred to EMS. Vital sign BP 176/104 P88 O2 100% on room air.
53 2021-05-03 seizure On January 12 around 10:50 PM, patient began convulsing in her sleep similar to a seizure and lightl... Read more
On January 12 around 10:50 PM, patient began convulsing in her sleep similar to a seizure and lightly foaming at the mouth. By 11:20, police and emergency services had arrived and moved her into an ambulance for transport to a hospital. She stopped convulsing by about 11:20 but did not seem to become conscious until they arrived at the hospital around 11:50
53 2021-05-04 numbness, tingling patient described shooting pain, tingling and numbness in the left arm (arm of vaccination)
53 2021-05-04 pain in extremity I had my Covid Pfizer vaccine on 4/30 in the morning and only felt a mildly sore arm that evening. I... Read more
I had my Covid Pfizer vaccine on 4/30 in the morning and only felt a mildly sore arm that evening. I woke up the next morning to very stuffed ears, high pitched ringing in my ears...It was difficult to hear over the loud tone in my head/ears., My hearing declined Throughout the day by night time I have no hearing left in my right ear. I went to see my ENT specialist on Monday, 5/1/2021. I had a full audiology work up and meeting with my ENT. The exam so that I had 100% hearing loss in my right ear. I am having an MRI on Weds 5/12 and meeting again with my ENT on 5/18. I was put on a high dose of steroids, Prednisone, for the next 2 weeks. trying to get back some hearing.
53 2021-05-04 tingling, pain in extremity, numbness Night of vaccine (4/6) experienced: chills, slight soreness in injection arm, nausea, burning lips, ... Read more
Night of vaccine (4/6) experienced: chills, slight soreness in injection arm, nausea, burning lips, numbness of tongue, scratchy throat, swollen lips and tingling sensation on face, primarily left side above upper lip, legs and arms (paresthesia), extreme tiredness. This persisted, though did get a bit milder over the course of the next few days. (4/11-12) Sensation of tingling persisted and seemed worse throughout body primarily at night, lips continued to feel "burnt" and sore. (4/13) Spoke with my Dr about issues and was told I had an intense response to the vaccine and she would get the opinion of an allergist/immunologist as to whether this was an allergic reaction. (4/15) Tongue finally felt normal. Paranesthesia persisted primarily at night. (4/30) Headache, nausea and paranesthesia with both small toes on both feet feeling numb all day. At night paresthesia intensified in head area and pressure in head developed. (5/1) Went to urgent care after several phone conversations with nurses. EKS and blood work performed and urgent card Dr noted rare adverse reaction to vaccine.
53 2021-05-04 tingling Headache; tingling in arms and hand; severe lethargy; fever 101.8; This is a spontaneous report from... Read more
Headache; tingling in arms and hand; severe lethargy; fever 101.8; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non pregnant female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247),via unspecified route of administration, administered in left arm on 21Jan2021 at 13:00 (at the age of 53 years) as single dose for COVID-19 immunization. The patient medical history included vertigo, migraine, asthma. The patient had an unknown allergy to medications, food, or other. The concomitant medication that the patient received within 2 weeks of vaccination included pseudoephedrine hydrochloride (SUDAFED) and ibuprofen (ADVIL). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 the patient experienced headache, tingling in arms and hand, severe lethargy and fever 101.8. The patient did not receive treatment for the events. On 22Jan2021 the patient underwent lab tests and procedures which included body temperature was 101.8. fever. The outcome of event was recovered in 2021. No follow-up attempts are possible. No further information is expected.
53 2021-05-04 tenderness PATIENT STATES THAT WITHIN 2 WEEKS OF THE FIRST VACCINE SHE NOTICED BREAST SWELLING, NIPPLE INVERSIO... Read more
PATIENT STATES THAT WITHIN 2 WEEKS OF THE FIRST VACCINE SHE NOTICED BREAST SWELLING, NIPPLE INVERSION AND TENDER AXILA OF THE RIGHT BREAST. SHE RECEIVED THE SECOND VACCINE AS TOLD TO DO . SHE CAME IN FOR AN EXAM ON 4-16-21 AND WAS SENT FOR EVALUATION BY MAMMOGRAM.
53 2021-05-05 weakness 4/2/21 woke up with whole left side without feeling/weakness, to ER, stroke ruled out, sent home, pr... Read more
4/2/21 woke up with whole left side without feeling/weakness, to ER, stroke ruled out, sent home, progressively got weaker. Blood pressure and pulse remaining low around 114/58 and 48 despite no longer taking BP meds. Passed out 2am 4/4/21, 911 to hospital. Continued to decline, sent to acute rehab 4/7-4/10. d/c'd home currently wearing heart monitor for 30days, follow up with neuro tomorrow 5/7, f/u with cardio 5/14. Therapy twice a week.
53 2021-05-05 bell's palsy Bell's palsey. To be treated with prednisone valacyclovir Referred to neurology
53 2021-05-05 breast pain breast soreness--cancer
53 2021-05-05 pain in extremity, tingling Guillain Barre Acute severe bilateral leg pain (3/30/2021), tingling, subsequent foot drop (4/13/21)
53 2021-05-05 pain in extremity Lemon size swollen lymph node in axilla. Denied redness or warmth. C/O constant pain in Left arm a... Read more
Lemon size swollen lymph node in axilla. Denied redness or warmth. C/O constant pain in Left arm and pain increases with activity with pain more concentrated in L) elbow. Pain wakes her up at night. Took aleve, used heat and biofreeze to alleviate pain and didn't help. When having pain with activity c/o pain 7-8. 5/5/2021: Saw primary care provider. Started on Aleve 4 tabs daily for a week and Gabapentin 300mg PO daily.
53 2021-05-05 tremor The patient is a 53yo F with history of asthma, non-epileptic seizures who on 5/4/21 received the 1s... Read more
The patient is a 53yo F with history of asthma, non-epileptic seizures who on 5/4/21 received the 1st Pfizer vaccine of her vaccination series. Immediately afterward, she developed full-body shaking and SOB. She was immediately sent to the ER where she was found to have stridor but without angioedema, hypoxia, urticaria, vomiting, hypotension, or other signs of anaphylaxis. During her stay in the ER, I oversaw her care and her symptoms completely resolved after IM Epi, benadryl, famotidine, albuterol/iptratropium, steroids, and magnesium. After an observation period in the ED, she had no recurrence of symptoms and was ultimately discharged.
53 2021-05-06 migraine, weakness End of the second day, severe migraine has not gone away for 2 months some days debilitating other d... Read more
End of the second day, severe migraine has not gone away for 2 months some days debilitating other days not, fatigue, brain fog, nausea and vomiting don't know if it's due to the migraines or the vaccine or both
53 2021-05-06 pain in extremity Pain in armpit and upper back side of arm. Sore when touched. Swelling of lymph nodes in armpit. Sor... Read more
Pain in armpit and upper back side of arm. Sore when touched. Swelling of lymph nodes in armpit. Soreness, swelling, and pain decreasing over time but still present today, May 7th.
53 2021-05-06 tingling swelling of mouth, tongue and gums (resolved in 5 days) ; "pins and needles throughout body includin... Read more
swelling of mouth, tongue and gums (resolved in 5 days) ; "pins and needles throughout body including face" (resolved in 5 days); swelling in lymph nodes (greater swelling on vaccination side), resolved in 9 days. Reported to Dr. to confirm no known interaction with Trulicity.
53 2021-05-07 pain in extremity got COVID tested and they had COVID; got COVID tested and they had COVID; sore arm; stuffy nose; sin... Read more
got COVID tested and they had COVID; got COVID tested and they had COVID; sore arm; stuffy nose; sinus infection; upset stomach and chills; chills/was so cold teeth were chattering; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the second of two reports. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 53-year-old, via an unspecified route of administration, administered in left arm on 18Mar2021 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included she had colonoscopy and anaesthesia. Concomitant medication included daily vitamins. The patient previously took oxytocin (PITOCIN) and experienced uncontrollable shaking. The patient got chills, was so cold teeth were chattering, sore arm, muscle aches, tired, and stuffy nose after the first dose on an unspecified date in 2021. She got it late in the day, but she didn't noticed symptoms until the next morning. It was complicated because her and her husband got the shot on 18Mar2021 and didn't feel well from it over the weekend. She thinks 18Mar2021 was on a Thursday. They knew they would be down for the weekend. They started to feel worse and worse. She went to a (institution name) because she thought she had a sinus infection on an unspecified date in 2021. She got some medication. The next day she lost the sense of smell and taste. Then her husband and her got COVID tested and they had COVID on an unspecified date in 2021. Somewhere around the time she got the first shot she had been exposed to COVID. She had COVID for 2 weeks. She didn't have to be hospitalized and her oxygen levels were fine on an unspecified date in 2021. She had all other symptoms except fever, diarrhea, and oxygen depletion. She called and the vaccine was scheduled out far enough and she was past COVID so she could come and get second dose. With the first dose, it was hard to tell what was a reaction to the shot when it was actually her coming down with COVID. She did have an upset stomach and chills and the worst headache of her life, she had no energy on an unspecified date in 2021. The sore arm was obviously was from the shot. The sore arm was clearly a side effect, but it was hard to tell when the side effects were ending and when it was COVID. It was a weird coincidence that they got exposed and she feels that it was not related to shot. The events got COVID tested and they had COVID and sinus infection resulted in physician office visit. The outcome of the event got COVID tested and they had COVID was recovered on an unspecified date in 2021 after two weeks and for the rest of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021460871 same reporter, drug , event; different patient
53 2021-05-09 weakness Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Light... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild, Additional Details: Notified by another vaccinated person waiting that pts "eyes were rolling to the back of their head". RPh went over and pt was having difficulty speaking, difficulty breathing. Husband translated that she was saying she could not breathe. RPh instructed staff to call 911, grab epinephrine, grab pulse ox and BP cuff. Epipen was NOT administered although box was open and dose was taken out (EMS can confirm this as well). EMS arrived on scene when pts BP was 130/105, pulse 103, O2 sat 92.
53 2021-05-09 feeling hot I felt very hot (no fever) and was dehydrated due to the heat in my body. It lasted through the day... Read more
I felt very hot (no fever) and was dehydrated due to the heat in my body. It lasted through the day on Saturday (5/8/21) with a lot of fatigue. On Sunday (5/9/21) the feeling of being hot disappeared yet the feeling of "mild" fatigue continued. It was at that time on Sunday (5/9/21) that I noticed my eyes were very red and I had eye muscle pain in the eye socket when I moved my eyes. It has continued today on Monday (5/10/21).
53 2021-05-09 flushing, feeling hot Patient presented to the ED about an hour after receiving COVID vaccination. Per ED notes, " She exp... Read more
Patient presented to the ED about an hour after receiving COVID vaccination. Per ED notes, " She experienced facial flushing, chest tightness and difficulty breathing. She has a history of multiple allergies. Her chest feels tight but she has not been hearing herself wheeze she has been coughing quite a bit. She denies throat tightness. She feels hot and lightheaded. She is noticed that her face is red. Patient was given 50 mg of Benadryl p.o. and 40 mg of prednisone p.o. as well as an albuterol neb. The albuterol neb gave her significant relief from the chest tightness and I reexamined her lung and she still has no wheezing and she is moving air well. Sats have been fine the whole time she has been here the facial flushing diminished steadily. The patient did not want a wait for any more than an hour and a half. She states she is feeling much better. I will give her a prescription for prednisone, 5 days and an EpiPen."
53 2021-05-09 pain in extremity The night of 2nd vaccine: Extreme soreness and pain in left arm, from shoulder down to hand, to the... Read more
The night of 2nd vaccine: Extreme soreness and pain in left arm, from shoulder down to hand, to the point I could barely move arm; pain/soreness in right arm as well, even though this was not the arm that received either of the shots; headache; chills the night of vaccine and then again about 30 hrs after vaccine; sweating(unsure if I had fever that night), but this afternoon I did check temperature and it was 100.4; entire body ached the night of vaccine and into the following day; brain fog (like I'd been drinking alcohol); swelling at injection site that is still present; swelling of fingers (I can tell because I couldn't get my ring off without forcing it). This morning, Monday the 10th, awoke to still a lot of brain fog and feeling exhausted still swelling at injection site, but pain in the arm is almost gone. As of today at 1:30 p.m., found my abdomen (upper and lower) and entire back is covered in bright red (almost sunburn like) rash with a few small raised bumps here and there - the majority of the rash is smooth, but when you touch it it turns white like with a sunburn. I was in bed all day yesterday, Sunday, sleeping due to Extreme fatigue.
53 2021-05-10 feeling of body temperature change Got hot &cold chills for 2 days constant I was actually shivering.. Imediatly when got home got my p... Read more
Got hot &cold chills for 2 days constant I was actually shivering.. Imediatly when got home got my period heavy bleeding and cramps..set off my ibs..The spot where I got the shot is red Around my arm and hot, still is but not as hot 6 days later.. got headache which I still have But not as bad 6 days later . feel really dry and thirsty still feel off a little..did not have a temperature at all.
53 2021-05-10 pain in extremity Felt stinging in my right arm soon after vaccine injection; Felt slight sting in my neck and somethi... Read more
Felt stinging in my right arm soon after vaccine injection; Felt slight sting in my neck and something minor by my ear; Woke up with a very groggy feeling; couldn't look at self in the mirror and focus; arm was minorly sore; congestion in my head; fogginess; swollen lymph node behind my right ear; minor ache in right side of head/mild aching; sinus pressure in front of face now-near eyes and nose/sinus pressure; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 53-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unspecified route of administration in the right arm on 31Mar2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies, asthma as a child and some sinus infection history which was reported as not usual, all from unknown dates and unknown if ongoing. The patient had no allergies to medications, foods or other product. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Concomitant medications included Proflora women's Probiotic, Prebiotic, and cranberry, all from unknown dates for unknown indications. The patient reported that on 01Apr2021 at 08:00 she felt stinging in her right arm soon after vaccine injection and slight stinging in her neck and something minor by her ear. She reported the next day she woke up with a very groggy feeling and couldn't look at herself in the mirror and focus. She reported that on day 1 her arm was minorly sore, but this went away after day 2; she felt congestion in her head, fogginess, and swollen lymph node behind her right ear for 7 days. The reporter stated, "was thinking did the vaccine travel up to my head? Did I have a sinus infection?" The patient made appointments with an ear, nose, and throat doctor and a neurologist. The patient reported she improved slowly over 7 days and by day 8 still minor ache in the right side of head, ear node better. She reported day 9 sinus pressure in front of face now-near eyes and nose; day 10 mostly better in head but still some aching and sinus pressure, grogginess gone. No treatment was received for the events. The events required a physician office visit. The clinical outcomes of felt stinging in her right arm soon after vaccination, felt sting in her neck and something minor by her ear, woke up with a very groggy feeling, couldn't look at self in mirror and focus, swollen lymph node behind her right ear, arm was minorly sore, congestion in her head, fogginess, minor ache in right side of head/mild aching, and sinus pressure were recovered with sequel in Apr2021. No follow-up attempts are needed. No further information is expected.
53 2021-05-10 pain in extremity SYMPTOMS OF VACCINE ~ SAME DAY SITE SORENESS TO THE TOUCH & ARM HURT, BODY ACHES, FELT TIRED, SLEPT ... Read more
SYMPTOMS OF VACCINE ~ SAME DAY SITE SORENESS TO THE TOUCH & ARM HURT, BODY ACHES, FELT TIRED, SLEPT ALL DAY. TWO DAYS AFTER, I FELT TOTALLY DRAINED & MY THOUGTHS WERE/ARE (STILL TO DATE 5/11/2021) EXTREMELY 'OFF' & 'FOGGY', NOT THINKING STRAIGHT, FOCUS & CONCENTRATION ARE BOTH WAY OFF. NOT AT ALL FEELING LIKE MYSELF.
53 2021-05-10 tingling, numbness As soon as I sat down to wait for the "clear to go" instructions, my left arm and left fingers start... Read more
As soon as I sat down to wait for the "clear to go" instructions, my left arm and left fingers started to feel very numb and tingly. It has not gone away. I thought it would on its own.
53 2021-05-10 tremor, weakness swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremo... Read more
swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremors; swollen sore lymph nodes (one week later under LEFT arm); swollen sore lymph nodes (one week later under LEFT arm); dizzy; extreme fatigue; elevated/irregular resting heart rate; elevated/irregular resting heart rate; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 08:15 (Lot Number: Ep7533) as SINGLE DOSE for covid-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of vaccine in Arm left on 11Mar2021 08:15 AM (Lot Number: En6201) also at age of 53 years old for covid-19 immunization, experienced elevated resting heart rate, weakness, dizzy, extreme fatigue, headache. Medical history included Hashimoto hypothyroidism. Concomitant medications included levothyroxine; estradiol; progesterone; testosterone, all taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, chills, body ache, headache, tremors, swollen sore lymph nodes (one week later under left arm), dizzy, extreme fatigue, elevated/irregular resting heart rate, swooning feeling when elevating body temperature. The events onset date were reported as on 09Apr2021 06:00 AM. It's unknown if patient received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
53 2021-05-10 tremor, feeling cold, pain in extremity tired; Muscle ache; stuffy nose; got cold, so cold; Chills/so cold her teeth were chattering; uncont... Read more
tired; Muscle ache; stuffy nose; got cold, so cold; Chills/so cold her teeth were chattering; uncontrollable shaking; sore arm; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 22Apr2021 at 06:20 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included sinus infection and colonoscopy from an unknown date and unknown if ongoing. The patient's concomitant medication included daily vitamin (unspecified). The patient previously took bnt162b2 for COVID-19 immunisation on 18Mar2021 (at the age of 53-years-old) and experienced sore arm, muscle aches, tired, stuffy nose, had been exposed to COVID, an upset stomach, chills, worst headache and had no energy. The patient also previously took oxytocin (PITOCIN) and experienced uncontrollable shaking. It was reported that her arm got sore pretty quickly after the second dose on 22Apr2021. The sore arm is ongoing. Her arm is killing her. It was ok, she took the Advil. She didn't think she felt that bad. She could tell she would be tired last night from it. Then she got cold. The heat was on 70 and she got cold and had chills and shaking and couldn't stop. When she woke up this morning (23Apr2021), she had other muscle aches and stuffy nose. She feels a little tired this morning. She thinks that will be gone in a day or so. The patient underwent lab tests and procedures which included oxygen saturation: fine on an unspecified date. Therapeutic measures were taken as a result of chills/so cold her teeth were chattering and sore arm. The outcome of the event sore arm was not recovered; chills/so cold her teeth were chattering and uncontrollable shaking was recovered on 22Apr2021, while of the rest was unknown.
53 2021-05-11 discomfort, pain in extremity Sore arm never got better and in fact got worse over time. Difficulty lifting, pushing, carrying, ra... Read more
Sore arm never got better and in fact got worse over time. Difficulty lifting, pushing, carrying, raising arm over shoulder. Still causing discomfort after 6 weeks. Went to dr. and diagnosed rotator cuff tendinitus as a result of poorly placed injection of needle. Just started PT this week.
53 2021-05-11 hot flush Headache, hot flashes, restlessness, fatigue. All symptoms lasted about 12 hours, except hot flashes... Read more
Headache, hot flashes, restlessness, fatigue. All symptoms lasted about 12 hours, except hot flashes (which lasted about 16 hours) and fatigue (which continued for a couple of days).
53 2021-05-12 hot flush Feverish (temperature normal), fatigue and headache the second day from injection and lasted for one... Read more
Feverish (temperature normal), fatigue and headache the second day from injection and lasted for one day. About a week after the second dose, I started to have hot flashes. This is not likely due to menopause for I had that for a few months two years ago. Now it is 4 months after the COVID vaccines and I still have it more than a dozen times a day.
53 2021-05-12 numbness Facial Numbness Sensation started approximately 20 minutes after vaccination , improved with time a... Read more
Facial Numbness Sensation started approximately 20 minutes after vaccination , improved with time and mostly resolved 2 weeks after injection. injection site tenderness, still continuing at 3 weeks out after vaccination. Chills started approximately 3 hours after vaccination and resolved within 12 hours. Minor headache/forehead tension/brain fog started a couple of hours after vaccination and not fully resolved.
53 2021-05-12 tingling Had mild tingling on the left side of my face. Started close to the ear and spread across the left s... Read more
Had mild tingling on the left side of my face. Started close to the ear and spread across the left side to the middle of eyebrow. It started about 45-1hr after getting the 1st dose. Felt like getting a shot of novocaine from the dentist. It was mild but still concerning. I received acupuncture and after the session the tingling had gone.
53 2021-05-13 weakness Weakness and headaches. It worsened to I had a fever. I was unable to breathe right; coughing; sore ... Read more
Weakness and headaches. It worsened to I had a fever. I was unable to breathe right; coughing; sore throat. I would walk for a couple of steps and I would be very, very tired. No appetite. If I took something even dry crackers I would vomit. I was off for two weeks. I had an in person doctor appt. First they gave me an antibiotic and that didn't work. I was placed on prednisone (two rounds) and I had breathing treatments nebulizer. These helped with the symptoms.
53 2021-05-13 discomfort The effect happened at 7:00 pm in the evening I got headaches, chilled, I did not get enough sleep b... Read more
The effect happened at 7:00 pm in the evening I got headaches, chilled, I did not get enough sleep because of coughing a lot and my left shoulder is painful and heavy some ,skin itchy in my arms and face.
53 2021-05-13 facial pain Face got shingles on its left side by my mouth but it's not a cold sore; red, hurt, little blisters ... Read more
Face got shingles on its left side by my mouth but it's not a cold sore; red, hurt, little blisters and itching on left side of my face; it's gotten bitter; side of my face by my mouth is red, it hurt, little blisters; side of my face by my mouth is red, it hurt, little blisters; they are itching this is on the left side of my face; side of my face by my mouth is red, it hurt, little blisters; Feels like my face is swelling; Left eye is itchy; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot Number: ER8732) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included: Allergy, double amputee. Concomitant medications included lamotrigine (LAMOTRIGINE); alprazolam (XANAX); venlafaxine (VENLAFAXINE); aripiprazole (ABILIFY); diclofenac diethylamine (DIFENAC [DICLOFENAC DIETHYLAMINE]); diphenhydramine hydrochloride (BENADRYL); ibuprofen (IBUPROFEN); eszopiclone (LUNESTA); budesonide, formoterol fumarate (SYMBICORT); (ALBUTEROL); all taken for unspecified indications, start and stop dates were not reported. The patient had her (first) Covid shot yesterday and her face got shingles on it now and it's on the left side by her mouth but it's not a cold sore. Reported as "shingles, on the side of my face by my mouth is red, it hurt, little blisters and they are itching this is on the left side of my face/ Face got shingles on its left side by my mouth but it's not a cold sore; red, hurt, little blisters and itching on left side of my face; it's gotten bitter. My left eye is itchy and it feels like my face is swelling." The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
53 2021-05-13 hot flush Had second CoviD shot. Waited 15 minutes and felt fine. One my driving home, I suddenly felt nausous... Read more
Had second CoviD shot. Waited 15 minutes and felt fine. One my driving home, I suddenly felt nausous, hot flash, moth tingling and felt like tounge/throat was swelling. I was on the highway and closer to city I lived. By time I was there was dizzy, heart ponding and trouble breathing. - Gave me EpiShot and called Ambulance -Unsure what I was given in the ambulance by IV -Went to ER and given Benadryl, Pecid and Solu-Medrol for swollen throat/mouth. -Sent home later with EpiPen and steriods. --Mouth now gets "tingaly" when I took steriod with minor swelling. (so stopped) Also now with some foods and drinks now. (Such as coffee, peanuts- taste is off)
53 2021-05-14 pain in extremity On Sat 5-15 at 2:00 AM woke up with extreme pain in left arm from shoulder to elbow. Pressure , pain... Read more
On Sat 5-15 at 2:00 AM woke up with extreme pain in left arm from shoulder to elbow. Pressure , pain and squeezing sensation. Experienced nausea as well. Event lasted approximately 1 hour.
53 2021-05-14 pain in extremity Temperature, pain in left arm, tiredness, bone pain, chills, cough with phlegm, diarrhea and loss of... Read more
Temperature, pain in left arm, tiredness, bone pain, chills, cough with phlegm, diarrhea and loss of smell and taste.
53 2021-05-15 weakness developed chest pain, heart rate increase and blood pressure increase. Chest pains lasted about 2 ... Read more
developed chest pain, heart rate increase and blood pressure increase. Chest pains lasted about 2 weeks but baseline heart rate went from resting average of 65 to resting in mid to high 80s and increased with light activity to over 110, this has continued even now several months later. Blood pressure when from average baseline of about 125/78 with 12.5 mg of Losartan taken for renal protection to requiring 75-100 mg daily with persistent BP of 150/100 or higher. this has resulted in ER visit. These numbers have not normalized. I am now taking Losartan 50 mg and Toprol 25mg daily. The chest pain happened after the second injections on 2/2/21 also about the exact same time frame. it was positional like a pericarditis type pain. Both time the Chest pain resolved after about 2 weeks. the heart rate and blood pressure are still elevated, heart rate is coming down but BP is still volatile. I did not think the first time was the vaccine but then it happened again exact same time frame after dose 2. I am now convinced this was absolutely a vaccine reaction.
53 2021-05-15 numbness, burning sensation, facial pain Mild headache began after second dose, continued and a week later i was in urgent care with terrible... Read more
Mild headache began after second dose, continued and a week later i was in urgent care with terrible pain in the left temple, left temple painful to touch, left side of face painful to touch. Pain in jaw, neck, trouble eating, talking, pain in back of head, nubness, burning and sometimes stabbing pain.
53 2021-05-16 weakness 5/14 11:50 pm chills, dry heaves, body aches , extreme headache. Took 2 Exedrin Migraine tablets. ... Read more
5/14 11:50 pm chills, dry heaves, body aches , extreme headache. Took 2 Exedrin Migraine tablets. Chills, and aches lasted approximately 4 hours. 5/15 4am still had a headache and body aches and was very tired but the pain kept me from sleeping 5/15 5am I took 2 acetominofen tablets, drank some apple juice, tried eating toast but felt nausea, fell asleep for a couple hours but woke still with a headache and body aches. 5/15 9am conditions continued and I took 2 ibuprofen tablets. I was able to sleep for about 4 hours. 5/15 2pm chills are gone, body aches were not severe but present, headache still bad. 5/15 slept through the night for the most part - very exhausted. 5/16 at 6am was able to eat and my body was not in pain. Had no energy all day and my thoughts were slow to think through. This condition lasted all day. 5/17 6am woke still with a headache - went away about 2:30 pm
53 2021-05-16 numbness, tingling Approx 40 minutes after the injection my face became tingly - cheeks, nose, around my mouth, and chi... Read more
Approx 40 minutes after the injection my face became tingly - cheeks, nose, around my mouth, and chin. It continued to tingle and became numb. (Felt similar to having Novocain for a dental procedure. By morning my cheeks and nose felt normal but the numbness/tingly feeling around my mouth and chin lasted about 20 hours. I contacted the care line and she was not initially familiar with this side effect. She did some research while I was on the line and explained that there have been some reactions of numbness. She said it was not an emergency and if it persisted beyond 24 hours I should seek medical attention.
53 2021-05-16 numbness Numbness of left side of body, arm, face and tongue. Treatment-rest and liquids.
53 2021-05-16 muscle spasms Muscle spasms starting a few hours post first injection - back, facial, neck and persistent for 6 we... Read more
Muscle spasms starting a few hours post first injection - back, facial, neck and persistent for 6 weeks. Second dose was not administered.
53 2021-05-16 muscle spasms Extremely heavy menstrual period, intense cramping and menstruated cycle has lasted 13 days as of to... Read more
Extremely heavy menstrual period, intense cramping and menstruated cycle has lasted 13 days as of today which is highly unusual.
53 2021-05-16 pain in extremity, burning sensation, breast pain Lymph nodes under my arm swelled up two days after second injection. Day three my underarm and brea... Read more
Lymph nodes under my arm swelled up two days after second injection. Day three my underarm and breast became very painful, felt like a burning sensation, even as swelling went down. This lasted over three weeks. I went to my OBGYN after two weeks who gave me a breast exam and stated it was reactive tissue from the vaccine.
53 2021-05-17 bell's palsy Bell Palsy
53 2021-05-17 cold sweat, feeling hot patient became very dizzy and light headed about 5 minutes after receiving vaccine. She also felt ho... Read more
patient became very dizzy and light headed about 5 minutes after receiving vaccine. She also felt hot and clammy.
53 2021-05-17 numbness, tingling Client stated she felt her heart starting to beat faster. And 30 minutes later her left arm was fee... Read more
Client stated she felt her heart starting to beat faster. And 30 minutes later her left arm was feeling numb and tingled. She also stated she was getting a headache on the left side of her head above the ear.
53 2021-05-17 numbness Client c/o numbness in hand, and hand felt "heavy." Also c/o of being sweaty. Vital signs WNL. She l... Read more
Client c/o numbness in hand, and hand felt "heavy." Also c/o of being sweaty. Vital signs WNL. She left site at 2:15pm unassisted and with a family member.
53 2021-05-17 numbness pain after 1 st injection ; second injection patient experienced numbness down arm that received inj... Read more
pain after 1 st injection ; second injection patient experienced numbness down arm that received injection. (this numbness was not a previous symptom of patient/ patient does have peripheral neuropathy in history; still numb almost 1 month after symptom started
53 2021-05-17 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild
53 2021-05-18 burning sensation skin flaked off on checks and around my mouth; Burning sensation; Raised red rash on my face and nec... Read more
skin flaked off on checks and around my mouth; Burning sensation; Raised red rash on my face and neck; This is a spontaneous report from a contactable Consumer. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 14:00 (Batch/Lot Number: EL9267; 53-year age at time of vaccination) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient previously took bnt162b2 first dose Left arm on 23Jan2021 02:00 (Lot number= EL0142) for covid-19 immunisation; Allergic to betadine, Balsam. On 19Feb2021 14:00, it was reported raised red rash on my face and neck. burning sensation and skin flaked off on checks and around my mouth. Patient received treatment with steroids. Patient not had covid prior vaccination; covid not tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Skin Disorders, Burning Sensation, Rash Erythematous and the suspect BNT162B2.
53 2021-05-18 feeling of body temperature change started being light headed at noon, then just didn't feel well. like achy, by 5:00 i was having bad ... Read more
started being light headed at noon, then just didn't feel well. like achy, by 5:00 i was having bad headache and feeling so achy in all my muscles and joints. worsened thru night with hot and cold body aches. Did not sleep for the pounding in my head and tremendous ache in body. All day the next day worsened. it wasn't till 18 hrs later i felt better but was still lightheaded.
53 2021-05-18 muscle spasms Within minutes of getting the shot the muscle under the shot began to spasm and it has not stopped f... Read more
Within minutes of getting the shot the muscle under the shot began to spasm and it has not stopped for the past six hours and still going. It will twitch for about 30 seconds then stop for 30 seconds then start twitching again.
53 2021-05-18 pain in extremity, tenderness Days after receiving my second Pfizer Covid-19 shot in my right arm, the injection site of my first ... Read more
Days after receiving my second Pfizer Covid-19 shot in my right arm, the injection site of my first shot in my left arm began to hurt much like I had just received that shot. It was painful to the touch and also to move. This remained for a number of days even after the injection site of my second dose went away after just 1 day. I still have lingering pain in my left arm ( first dose injection site arm) I can move my arm fully to the front but can not raise it out to the side without pain. It prevents me from doing many daily activities that require movement of that arm, from putting dishes into the cabinet, to lifting/ picking up everyday items, to gripping the doorknob to open a door. The pain has subsided but does occasionally 'sting' me with a sudden burst when using that arm. I did not have any of these symptoms prior to receiving my second dose of Covid19 vaccine.
53 2021-05-18 pain in extremity Sore left eye which lasted 5 days. Sporadic shoulder and arm pain for the 1st 7 days; has now starte... Read more
Sore left eye which lasted 5 days. Sporadic shoulder and arm pain for the 1st 7 days; has now started to get progressively worse. Constant throbbing pain from the shoulder through the tips of my fingers.
53 2021-05-18 pain in extremity I experienced left sore arm after my Pfizer vaccine. I had two episodes and I do not know if they a... Read more
I experienced left sore arm after my Pfizer vaccine. I had two episodes and I do not know if they are related to the Pfizer vaccines. Feb 28,2021 @ 10pm, severe onset vomiting. March 15, 2021 @9:45am had a mild stroke. I was in ICU, CT scans, MRI, echocardiogram, extensive blood work done. They also put in a heart monitor.
53 2021-05-19 feeling hot pneumonia; I've been very very sick; body ache; chills; nausea; so tired/very exhausted; fever 99.3F... Read more
pneumonia; I've been very very sick; body ache; chills; nausea; so tired/very exhausted; fever 99.3F; a very strong headache; sore throat; The arm is very hot and swelling; The arm is very hot and swelling; pain in the back, neck and everything; pain in the back, neck and everything; shortness of breath; My eyes are so hot and burning; earache; she is not feeling very well; she had a really sore arm in the area of the shot; her head is foggy this morning and all day; This is a spontaneous report from a contactable consumer. A 54-year-old female patient (Age at time of vaccination 54 years) received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 04May2021 at 16:00 (Batch/Lot Number: EW0176) as SINGLE DOSE for covid-19 immunization. Medical history included back injury, neck injury, Knee Surgeries, 2 Bulging Discs, Heel Spurs and Sciatic all on the left ongoing since 2010 and Covid-19 on 29Mar2020. The patient's concomitant medications were not reported. The patient experienced pneumonia, i've been very very sick, body ache, chills, nausea, so tired/very exhausted, fever 99.3f, a very strong headache, sore throat, the arm is very hot and swelling, pain in the back, neck and everything, shortness of breath, my eyes are so hot and burning, earache, she is not feeling very well, she had a really sore arm in the area of the shot and her head is foggy this morning and all day all on 05May2021. Consumer reported "Since this morning I've been very very sick. I'm sick. I have body ache, chills, nausea, so tired, fever 99.3F, a very strong headache, sore throat. The arm is very hot and swelling. I had Tylenol this morning nothing is working. The body ache is so horrible, pain in the back, neck and everything. I had covid on march 29 last year, I had pneumonia. I have lingering issues, body ache and pain, I still get very tired, shortness of breath; I feel like it's coming back after getting the vaccine. My eyes are so hot and burning, you know the sensation when you have a fever. Commented how she felt like she was getting covid again after getting the vaccine. Yesterday, 04MAY2021, she was vaccinated with the Pfizer Covid Vaccine. States it was her first dose and she is having a lot of side effects. Her temperature is 99.2, she has body aches, earache, headache, a little bit of shortness of breath, very tired, very exhausted and she is not feeling very well. She is wondering if this is a normal reaction for the first vaccine? States it feels like when she had Covid. Clarifies at she was fine last night other than she had a really sore arm in the area of the shot and it is really hot, like if she has a fever in the area. States at 9:30-10:00 a.m. this morning she started having a headache, chills, and nausea. She took a hot shower, and had some tea and took Tylenol. It is progressing worse and worse. States she has body aches and fever getting warmer and warmer, and her throat feels a little bit sore. States all of them are getting worse. She is staying home and laying down not trying to do a lot, drinking water and staying hydrated. States she spoke to a friend and she said she is not supposed to get these side effects with first one. Her body aches are horrible, it feels like when she got the virus, all the aches and pains. Her head is foggy this morning and all day, and she has issues with pain all over, so much body aches. States she is reporting her side effects and she read the side effects but it seems like when she had Covid last March and she is still going through a lot of issues with it, the pain Covid left her with. States she did a Covid test, and she had antibodies, but this feels like the virus again. States she has the same symptoms as when she got the virus. Treatment: Took 2 Tylenol and nothing seems to help. UPC and Expiration: Unknown Lot: 110856. Caller states the UPC and Expiration got erased because she has had it for awhile. Tylenol Rapid Release 500mg.Caller states she took a hot shower, and had some tea. Caller states she is staying home and laying down not trying to do a lot, drinking water and staying hydrated. The outcome of the event pneumonia was unknown. Outcome of all the other events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-05-19 feeling hot face swelling; cheeks were red and hot; cheeks were red and hot; hives on my neck; Allergic reaction... Read more
face swelling; cheeks were red and hot; cheeks were red and hot; hives on my neck; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169, expiration date not provided), 1st dose via an unspecified route of administration, administered in arm right on 20Apr2021 at age of 53 years old as a single dose for COVID-19 immunisation. Medical history included anxiety, known allergies: fruits with a seed in the center i.e. peaches, cherries, apricots etc (fruit allergy). Concomitant medication included sertraline. The patient experienced allergic reaction including face swelling, cheeks were red and hot and hives on my neck., all on 20Apr2021 12:30. No treatment received for the events. The outcome of the events was recovered in 2021. The report was reported as non-serious by reporter. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.
53 2021-05-19 flushing I had the vaccine and after 10 minutes after my throat and esophagus were itching but it didn't clos... Read more
I had the vaccine and after 10 minutes after my throat and esophagus were itching but it didn't close up, they gave me water and I was able to drink it but someone told me I was flushing and my heart rate increased and they had EpiPen's ready but they wanted to do liquid Benadryl first and it calm everything down. The next day about noon time my face turn bright red and my right side was swollen and I did more liquid Benadryl and that was fine. 2 days after the shot my arm was itchy and the next day my arms were fine but the next day my legs were itchy and I took more liquid Benadryl and then I was fine after that. My doctor told me to not take the 2nd vaccine because of my allergic reaction.
53 2021-05-19 hot flush extreme fatigue since April 21; chemical type burn appeared at injection site on April 23; May 2 had... Read more
extreme fatigue since April 21; chemical type burn appeared at injection site on April 23; May 2 had sudden drastic drop in blood pressure (symptoms were nausea, extreme hot flash with profuse sweating; lightheadedness to the point I thought I would pass out, dizziness); May 15 both arms broke out into a rash
53 2021-05-19 throat numbness, numbness, muscle spasms Brain fog, Right face numbness. Right arm injection site pain, charly horse and still with pain with... Read more
Brain fog, Right face numbness. Right arm injection site pain, charly horse and still with pain with movement now. Right arm numbness down to right leg numbness at times. Left side cheek, throat numb feeling. Tongue feels numb and down thoracic spine.
53 2021-05-19 speech disorder mouth and tongue started feeling like she ate or drank something way too hot felt burning; mouth and... Read more
mouth and tongue started feeling like she ate or drank something way too hot felt burning; mouth and tongue started feeling like she ate or drank something way too hot felt burning; tongue was swollen; tongue was swollen and really red; tongue was swollen and really red making it difficult to speak; can't taste plus eating was difficult; can't taste plus eating was difficult; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 16:30 (Lot Number: EW0167) as 1st dose, single for covid-19 immunization, administered at the hospital. Medical history included rheumatoid arthritis. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took Xarelto and experienced allergies: adverse reaction to Xarelto. On 01May2021 at 17:00, patient's mouth and tongue started feeling like she ate or drank something way too hot felt burning, have it another day or two and getting worse; her tongue was swollen and really red making it difficult to speak the swelling and redness was nearly an inch and can't taste plus eating was difficult because it feels like she burnt her mouth and very uncomfortable. The patient didn't have any of these symptoms before the vaccine and initially not worried as both of her daughters are nurses and has heard of it but nothing to this extreme. The patient was advised to contact her doctor on 07May2021 or if worse, urgent care. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported events and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
53 2021-05-20 pain in extremity The same day after first inject got a sore arm as expected. The arm continue to stay sore up until... Read more
The same day after first inject got a sore arm as expected. The arm continue to stay sore up until second injection which I had doubted getting but did receive in the same arm on March 17,2021. My arm continued to hurt and went to see my general practice doctor who gave me naproxen to take in april 2021. On follow up appointment the arm still continued to be very sore and it was injected with a steroid. My arm never got better even after steroid so I made an appointment with Orthopedics. They took an xray, assessed it, and gave a diagnosis of frozen shoulder. I was prescribed a solumedrol dose pack which I completed this week but feel the soreness coming back after 3 days off dose pack. I have a follow up appointment on Monday 5/24/21 to evaluate effectiveness of steroids and other possible treatment plans.
53 2021-05-20 pain in extremity pt had severe headache, diarhea, fever and sore left arm. These symptoms lasted about 3 days except... Read more
pt had severe headache, diarhea, fever and sore left arm. These symptoms lasted about 3 days except the sore arm. Pts left arm pain never subsided and she had limited mobility. She rcvd the 2nd dose on 4/26/21 @ 10:45 in the left arm (lot # EW0161). Pt developed the same exact symptoms as she had with the 1st dose, the headache, diarhea, fever, and sore left arm. On 5/21/21 pt still has alot of pain with headache and sore left arm with very limited mobility. Pt will contact her PCP regarding her symptoms.
53 2021-05-21 facial paralysis, tremor, cold extremities, tingling fluctuating rapid heartbeat / my pulses goes from like 67 to 134; its feels like my muscles in my fa... Read more
fluctuating rapid heartbeat / my pulses goes from like 67 to 134; its feels like my muscles in my face not working well ,specially in my mouth itsreally concerning to me; almost collapsed while cooking; light headed and dizzy; cold tingling extremities; cold tingling extremities, buzzing , tingling and vibrating feeling; fatigue and exhaustion; tremors in face; my thyroid is been out of range though I am trying to get that back but I amreally worry; felt horrible; muscle weakness; instable in walking; chills; I am really worry; super strong neurological side effects/Having major neurological symptoms; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0172), via an unspecified route of administration, administered in Arm Left on 28Apr2021 at the age of 53 years as 2nd dose, single for COVID-19 immunization. Medical history included hypothyroidism, hypoglycaemia, small intestinal bacterial overgrowth, Epstein-Barr virus infection, mononucleosis (three times when I was younger), hearing impairment, and post menopausal from an unknown date. The patient reported that she was in good shape. Prior to all this she could walk 15000 steps a day and was in a good health. Concomitant medications included thyroid (ARMOUR THYROID) taken for hypothyroidism; valaciclovir hydrochloride (VALTREX) taken for Epstein-Barr virus infection; cetirizine hydrochloride (ZYRTEC) taken for sinus disorder, manganese taken for supplementation therapy; fish oil (OMEGA 3) taken for supplementation therapy; vitamin B6 taken for supplementation therapy; and vitamin B12 taken for supplementation therapy, all start and stop dates were not reported. The patient previously received the first dose of bnt162b2 on 07Apr2021 (lot number: ER8729) at the age of 53 years for COVID-19 immunization and experienced neurologic symptoms, body ache, chills, extreme fatigue, tingling in my extremities, like a buzzing sensation, vibrating sensation in my body, heart palpitation, cold extremities, extreme muscle weakness, "to the point even if even after making dinner I would feel like I was going collapse, and I could barely open my hand muscles", fluctuating rapid heart beat, muscles in my face not working, thyroid is been out of range, super light headed. The patient also received a flu shot on an unspecified date for immunization and had the flu. The patient reported having serious side effects to the vaccine. On 29Apr2021, 30 hours after the second dose, the patient had super strong neurological side effects/having major neurological symptoms. On an unspecified date after the second dose, the patient reported that she had fluctuating rapid heartbeat/my pulses goes from like 67 to 134, feels like my muscles in my face was not working well, especially in my mouth its really concerning, almost collapsed while cooking, light headed and dizzy, cold tingling extremities, buzzing, tingling and vibrating feeling, fatigue and exhaustion, tremors in face, thyroid has been out of range though I am trying to get that back but I am really worry, felt horrible, had muscle weakness, instable in walking, and chills. The patient underwent lab tests and procedures which included blood count: unknown results, Epstein-Barr virus test (viral load): heavy load, heart rate: 67, then 134, thyroid function test: out of range all on unspecified dates. The patient had a heart rate : 130 on 09May2021. The patient reported no treatment for the events. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
53 2021-05-21 tingling, cold extremities Neurologic symptoms; Body ache; Chills; Extreme fatigue; Tingling in my extremities/like a buzzing s... Read more
Neurologic symptoms; Body ache; Chills; Extreme fatigue; Tingling in my extremities/like a buzzing sensation, vibrating sensation in my body; Heart palpitation; Cold extremities; Extreme muscle weakness/could barely open my hand muscles; Fluctuating rapid heart beat/heart rate was like 130; Feels like my muscles in my face not working well, especially in my mouth; Thyroid is been out of range; Super light headed/dizzy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729; Expiration date was not reported) on the left arm 07Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, hypoglycaemia, small intestinal bacterial overgrowth, Epstein-Barr virus infection and sinusitis. Concomitant medications included thyroid (ARMOUR THYROID) for hypothyroidism; valaciclovir hydrochloride (VALTREX) for Epstein-Barr virus infection; and cetirizine hydrochloride (ZYRTEC ALLERGY) for sinusitis. In Apr2021, after the first dose of vaccination, the patient had neurologic symptoms; body ache; chills; extreme fatigue; tingling in the extremities/like a buzzing sensation and vibrating sensation in the body; heart palpitations; cold extremities; extreme muscle weakness that she could barely open her hand muscles, and would feel like she was going to collapse; fluctuating rapid heartbeat where heart rate was like 130; felt like the muscles in the face were not working well especially in the mouth; thyroid has been out of range; and was super light headed/dizzy. The patient had reported the events to be serious side effects (medically significant) of the vaccine. The outcome of the events was unknown. The patient had received the second dose of vaccination on 28Apr2021.
53 2021-05-22 burning sensation Woke up thrashing in bed with feet on fire and itching, sat up and throat, tongue, lips itchy with t... Read more
Woke up thrashing in bed with feet on fire and itching, sat up and throat, tongue, lips itchy with tongue and throat swelling. Took epinephrine breathing treatment, 100 mg of Benadryl, 40 mg prednisone, Duo neb breathing treatment. Another epinephrine breathing treatment. Symptoms lessened after taking medication. I have this medication d/t allergies and asthma. If symptoms had not improved I was prepared to go to ER to call an ambulance. SpO2 85% before breathing treatment and 89-90% after treatments. Medication started immediately upon waking and symptoms began improving within the first 20-30 minutes. Reported symptoms to work and did not go to work until 11 am and worked only till 1-2 pm. Also reported event to MD and was told not to take the next dose d/t reaction.
53 2021-05-22 discomfort, pain in extremity Noticed 4/5 days later that my face had swollen, and broken out a bit but not serious to go to ER. D... Read more
Noticed 4/5 days later that my face had swollen, and broken out a bit but not serious to go to ER. Days later, swelling is all over my body; hands, face, legs, knees, feet, arms. I feel extremely heavy and in much pain from the gain on my legs. I weighed 143 day of shot...4/5 days later 10 pounds happened, but not from eating...its swelling.
53 2021-05-23 facial paralysis, bell's palsy Bell?s Palsy- right side of face paralyzed with severe ear pain and loss of taste. Doctor prescribe... Read more
Bell?s Palsy- right side of face paralyzed with severe ear pain and loss of taste. Doctor prescribed Prednisone 10 mg and Valacyclovir 1g
53 2021-05-23 feeling hot, pain in extremity 05/21 intermittent breathing issues - full breath hard to take and caused a cough. happened once ... Read more
05/21 intermittent breathing issues - full breath hard to take and caused a cough. happened once every few hours lasted through 05/23 05/22 started feeling warm - low grade temp 98.9 around 4pm only lasted about 4 hours 05/22 body aches around 6pm - lasted until 05/23 am 05/23 fatigue - could not fully wake up. even when up eyes were heavy and felt like closing. 05/24 nausea in the morning. included vomitting. brief dizziness when went back to bed 05/22 - 05/23 diarrhea 05/22 - present. injection site sore / upper arm hurts 05/24 - midday - muscular pain around midsection - hurts when taking deep breath or twisting 05/22 - 05/23 chills 05/21 - 05/24 just not feeling good
53 2021-05-23 muscle spasms Patient reports that she has noticed her "nutcracker esophagus" has become more severe. She has noti... Read more
Patient reports that she has noticed her "nutcracker esophagus" has become more severe. She has noticed that she has more difficulty breathing, swallowing, speaking, upper torso muscle spasming, and some spasms in her esophagus.
53 2021-05-24 inability to speak Patient checked in to Immunization for Pfizer Covid Vaccine Dose #1 (LOT EW0183 EXP 08/21) at 1254 t... Read more
Patient checked in to Immunization for Pfizer Covid Vaccine Dose #1 (LOT EW0183 EXP 08/21) at 1254 then sent to observation area. shortly after receiving the dose of Pfizer covid vaccine, patient complaint of itchiness. Observer went to notify Nurse. Nurse noted patient was also having trouble talking and difficulty swallowing and breathing. EPIpen was immediately administered to Right Thigh (0FM500 exp May 22) at 1325. Patient states she has history of Anaphylaxis with Influenza vaccine and a "list" of medications. Patient stated immediately after receiving the COVID vaccine, when itchiness began she self medicated with 25mg of Benadryl PO when she alerted the Observer of the itchiness. Code was called at 1331 and transported to ED for further treatment and evaluation. Nurse from Immunizations went with Code team member to transport patient to ED when 2nd Epipen (0FM407 EXP FEB22) was administered with direction of MD in elevator after patient began having tightness in chest and grabbing throat.
53 2021-05-24 numbness, pain in extremity Soreness, weakness, pain shooting down arm, when picking item up will lose feeling in lower arm and ... Read more
Soreness, weakness, pain shooting down arm, when picking item up will lose feeling in lower arm and fingers.
53 2021-05-24 numbness c/o tightness of her left arm and jaw and also c/o facial numbness. BP 150/101, HR 87, pt. went hom... Read more
c/o tightness of her left arm and jaw and also c/o facial numbness. BP 150/101, HR 87, pt. went home after symptoms was resolved.
53 2021-05-25 feeling hot The patient was nervous about getting the vaccine. As soon as I injected the vaccine, she stated it ... Read more
The patient was nervous about getting the vaccine. As soon as I injected the vaccine, she stated it felt like fire in her arm. Within a few minutes, she stated she felt very hot and she started hyperventilating. I called 911 and tried to assist with her breathing. When the paramedics arrived, they took her blood pressure. Since her blood pressure was very elevated, they transported her to the hospital.
53 2021-05-25 pain in extremity Left arm sore; swollen at the edges of the lid with secretions; red at the edges of the lid; Left ey... Read more
Left arm sore; swollen at the edges of the lid with secretions; red at the edges of the lid; Left eyelid began to get sore; shoulder were very sore; Pain in jaw near my earlobe when chewing; This is a spontaneous report from a non-contactable Non-Health Care Professional (Consumer or other HCP). A 53-years-old non-pregnant female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot/batch no: EN6208) as a single dose on an unspecified route administered in left arm on 12Mar2021 at 8:00am (at the age of 53-year-old) for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. Patient past drug includes penicillin allergy. The patient lab test was not reported. On 12Mar2021, patient experienced left arm sore, shoulder very sore and on the same day patient experienced left eyelid began to get sore, red and swollen at the edges of the lid with secretions for four days and also had pain in jaw near earlobe while chewing. Therapeutic measures were not taken for any events. The clinical outcome of the events was reported as recovering. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Also, the patient was not tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.
53 2021-05-25 tingling, numbness Face is numb and tingly; Face is numb and tingly; This is a spontaneous report from a contactable no... Read more
Face is numb and tingly; Face is numb and tingly; This is a spontaneous report from a contactable non-health care professional, the patient. A 53-years old non-pregnant female patient received BNT162B2 (BNT162B2) (Lot/batch no: EP7534), via an unspecified route of administration on the left arm, as second dose, single on 16Mar2021 at 09:00 (at age of 53 years old) for COVID-19 immunization. Medical history included hypothyroidism. Past drug included BNT162B2 (BNT162B2) (Lot/batch no: EL9267), via an unspecified route of administration on the left arm, as first dose, single on 23Feb2021 at 10:00 for COVID-19 immunization. Concomitant medications included levothyroxine. Allergies included allergy to sulfa drugs. Prior to vaccination, patient had not been diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021 at 09:15, the patient experienced numbness and tingling on her face. The patient did not receive any treatment for the events. The patient was not recovered from the events. No follow-up attempts are needed.
53 2021-05-26 inability to speak, feeling hot 5/25/2021: Patient checked in to Immunization for Pfizer Covid Vaccine Dose #1 (LOT EW0183 EXP 08/21... Read more
5/25/2021: Patient checked in to Immunization for Pfizer Covid Vaccine Dose #1 (LOT EW0183 EXP 08/21) at 1254 then sent to observation area after vaccine administration. Shortly after receiving the dose of Pfizer covid vaccine, patient had complaint of itchiness. Observer went to notify Nurse. Nurse noted patient began to have trouble talking and difficulty swallowing and breathing. EPIpen was immediately administered to Right Thigh (0FM500 exp May 22) at 1325. Patient states she has history of Anaphylaxis with Influenza vaccine and a "list" of medications. Patient then stated that immediately after receiving the COVID vaccine, when itchiness began she self-medicated with 25mg of Benadryl PO when she alerted the Observer of the itchiness. Code was called at 1331 and transported to ED for further treatment and evaluation (via wheelchair as awake, alert and oriented). Nurse from Immunizations went with Code team member to transport patient to ED when 2nd Epipen (0FM407 EXP FEB22) was administered with direction of MD in elevator after patient began having tightness in chest and grabbing throat. Patient care transferred to ED. Code cleared at 1348. 5/26/21: Follow up: This 53 yo stated within 5 min after yesterdays vaccination she was itching all over and felt hot and skin bumpy (rash). She took a benadryl and told staff and they gave her total of 2 epi pens due to c/o hoarse thick feeling in throat, SOB, chest tightness, (states this reaction was much faster than past reactions to other medications). Today she is doing well, no further itching, redness, tight throat, no SOB/CP and reports no fevers, HA, arthralgia, muscle aches or site irritation post vaccination. She is continuing the 3 medications given on discharge (steroid, 2 antihistamines) and is drinking lots of water to flush her system. She has family in the house with her.
53 2021-05-26 tingling Light headache; Felt left eye is tiring; Injection site sore; Short period of tinkling in left side ... Read more
Light headache; Felt left eye is tiring; Injection site sore; Short period of tinkling in left side of the brain; eye lid is heavy; This is a spontaneous report from a non-contactable consumer or other non hcp. A 53-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in arm left on 23Feb2021 09:00 as 1st dose, single dose for covid-19 immunisation. The patient's age at vaccination was 53 years. The patient was not pregnant. The patient's medical history and concomitant medications were not reported. On 23Feb2021 15:00, the patient experienced injection site sore, light headache, short period of tinkling in left side of the brain, feel left eye is tiring, eye lid is heavy. Vaccine facility type was other. The patient did not have any other vaccine in four weeks. No covid test was done post vaccination. The patient did not have any known allergies and other medical history. Therapeutic measures were taken as a result of injection site sore, light headache and short period of tinkling in left side of the brain with Tylenol. The outcome of the events was recovered on an unspecified date 2021. No follow-up attempts are possible. No further information is expected.
53 2021-05-27 weakness Moderate to severe headache, nauseated, extremely weak and tired. Could not get energy to get out of... Read more
Moderate to severe headache, nauseated, extremely weak and tired. Could not get energy to get out of bed to do anything except use restroom and grab prepared food/ drink from kitchen. Low grade fever until nightfall. Then fever up to 104f, Took Tylenol at night and woke up next morning and took another dose of Tylenol, felt better by noon. All symptoms resolved suddenly and no fever. Headache returned periodically throughout the following 2 months- minor to moderate made worse with a cough or strain. No prior history of headaches.
53 2021-05-27 pain in extremity severe Dysuria tested positive for HSV1 Genital; Low WBC count and low lymphocytes; Low WBC count an... Read more
severe Dysuria tested positive for HSV1 Genital; Low WBC count and low lymphocytes; Low WBC count and low lymphocytes; patient developed 102.6 fever; nausea; Swollen groin lymph nodes; kidney infection; severe UTI; the patient experienced bad leg pain; rash on legs; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 22Apr2021 13:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included breast cancer and Hashimoto disease. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at the age of 53-years-old on 01Apr2021 12:30 in the arm right for COVID-19 immunization. On 02May2021 22:00, the patient experienced bad leg pain, rash on legs, flowed by severe UTI and kidney infection. On 05May2021, day 3, the patient developed 102.6 fever, nausea, swollen groin lymph nodes, severe dysuria tested positive for HSV1 Genital, with bad lower pelvic pain, low WBC counts and low lymphocytes. The patient had 2 trips to ER in 3 days, missed 8 days of work due to the events. The patient received IV fluids, IV antibiotic, IV pain meds, anti-nausea as treatment for the events. The outcome of the event was recovered with sequel. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
53 2021-05-27 tingling, numbness, flushing After 1st dose, had tingling and numbness on face, lips, tongue and all through right arm/hand/fing... Read more
After 1st dose, had tingling and numbness on face, lips, tongue and all through right arm/hand/fingers; tingling on lips and tongue lasted for about 24-26 hours; throat tightness about 7 hours; face/cheeks were flushed, hot/warm, and slightly swollen; hand, arm, and lips still have occasional periods of tingling/numbness through current date
53 2021-05-28 discomfort itchy rash; itchy rash that looked like hives and was bumpy; itchy rash that looked like hives and w... Read more
itchy rash; itchy rash that looked like hives and was bumpy; itchy rash that looked like hives and was bumpy; she is not comfortable; She cannot sleep/has not gotten enough sleep; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 12May2021 16:45 (Lot Number: EW0183) as 1st dose, single for covid-19 immunisation (going to be traveling soon and needed it for work). The patient medical history was not reported. Concomitant medications included ongoing vitamin c [ascorbic acid] (VITAMIN C), ongoing vitamins nos (MULTIVITAMINS) and zinc with therapy date not reported, all for unknown indication. The patient has no previous immunization with the Pfizer vaccine considered as suspect or received additional Vaccines Administered on Same Date of the Pfizer vaccine. The patient did not receive other vaccines 4 weeks prior to vaccination. The patient mentioned that she had the vaccine yesterday, 12May2021 at 4:45pm in a hospital. She stayed for the 15 minutes after, and didn't feel anything but when she got home, she had an itchy rash (also reported as 02:30 am), like hives and she took some allergy pills. She further reported that when she got home, she felt something. It looked like hives and were bumpy, when she scratched it, it was like hives. It was in the middle of her body in the back, front and in her neck, that was 2:30 this morning. This afternoon, it was in her armpits, groin and all over. It happened again at 2:30am (13May2021), she had the itch again and took another pill. It has been on and off and is now all over her body and she is not comfortable. After lunch, again she took a pill and it hasn't stopped itching and is continuous. She mentioned that she has never had the flu shot. She was not planning to have this one, but her work said she had to get this. She did not have any allergic reactions to any vaccines in the past. She mentioned that she does not know what to do since the allergy pill does not work and she thinks she needs an injection. She added that her family (daughter is a nurse) is telling her this is not allergies it is the vaccine. The patient mentioned that the treatment used included allergy pills, an antihistamine, diphenhydramine, the generic form of Benadryl. She took the pills 3 times, every 3 hours. The adverse events did not require emergency room or physician office visit. The patient further mentioned that she just needs something stronger. She can't get any medicine for this and she would like to ask if she can get a steroid for this. She is not comfortable and has not gotten enough sleep. The patient is also going to ask for a prescription for Atarax, hydroxyzine. She added that she cannot sleep and the more she scratches it the worse it gets. Daughter told her she had to call because it is not just allergies. She took a shower to help the itchiness and it helped for a little bit. The outcome of the events was not recovered.
53 2021-05-28 numbness Numbness of the face; This is a spontaneous report from a contactable consumer (patient). A 53-year... Read more
Numbness of the face; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 26Feb2021 09:00 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was not pregnant. The patient did not take other vaccine in four weeks. The patient previously took iodine and experienced allergy. The patient experienced numbness of the face (non-serious) on 26Feb2021 09:05. No treatment was received. The outcome was recovered on 27Feb2021. No follow-up attempts are possible. No further information is expected.
53 2021-05-28 muscle spasms, pain in extremity Within 3 hours of getting the vaccine on May 14, 2021 I could not bend my right leg, could not squat... Read more
Within 3 hours of getting the vaccine on May 14, 2021 I could not bend my right leg, could not squat down, and had terrible pain throughout the back of my right calf and surrounding my knee and upper right thigh. During the next 2 days the pain increased and the swelling increased to become very visible to others. The muscles in my calf and thigh were so tight and so bound up that it looked like balls under the skin, as if I was in a constant state of chronic, extreme charlie horse. And that is also what it felt like. So very painful that I could not bear my own weight without crying. By Tuesday, May 18, 4 days later, I was having to use a cane or have someone by my side because the pain was so extreme and my right leg would spasm and buckle without warning. I called my doctor and made an appt. Pain continued throughout the week. I had to switch to a walker. I saw my doctor on Friday May 21st at 11 a.m. He was concerned about the vaccine causing blood clotting and due to the swelling, binding of muscles, and pain that he noted, he ordered an ultrasound for later that day. I had the ultrasound at 2 p.m.. My results were negative for blood clots. I went home to ice my leg and elevate it until I could see a Dr again the next week as it was now after hours and the weekend. At or around 6:30 p.m. that same night, Friday, May 21, I was standing up at my dining room table and felt and heard a horrific snap or pop. It was so excruciating. I fell to the floor and landed on my bottom first and then my back and right shoulder. I had to be allowed to lay on the floor for at least 20 minutes before I could calm myself from the pain and fear of being lifted off of the floor. I required being carried to my chair because when I tried to walk, my right foot would just drag. I could not lift it at this time. My family decided I needed to go to the emergency room, as did the on-call after hours doctor at my doctor's office whom I called. I was taken to the hospital because when we called they said they would do an MRI in the E.R. We had to use a wheelchair. After admitting me and going through all of the events, they informed me that they would not do MRI's in the E.R. unless the patient met a certain criteria of trauma and I did not..in their opinion. They sent me home with crutches and prescriptions. That weekend was pure hell, although, the muscles seemed to be diminishing in hardness and tightness and swelling with each day after I felt the snap. Regardless, I called my niece on Sunday to ask her to come stay with me and help take care of me until someone would order an MRI because the horrific pain was still there at random moments of trying to maneuver myself to the bathroom and bed. Finally, an MRI was ordered and I had it done on Wednesday, May 26, at 4:00 p.m.. I did not get the results until Friday, May 28, at appx 4 p.m. Full Thickness Tear in the Posterior Horn Medial Meniscus. It is my own and my family's absolute belief that the Phizer shot caused the binding of my leg muscles, of which they were relentlessly bound for almost 2 weeks, with the 1st week being the most painful and traumatic, subsequently causing my meniscus to snap. Even my Dr believed it was a possibility because of the stats on the vaccine and the fact that I had not injured myself previously or on the day of the vaccination. The pressure that was put on those muscles from the binding/balling and swelling were too much for my muscles and tendons to withstand. The Dr bills, the ultrasound, the E.R. bills, the crutches, the prescriptions, the MRI will all be coming out of my pocket because I am an uninsured, unemployed woman trying to protect herself and her community by getting a vaccination that was supposed to be a positive thing. Only, instead, it has crippled me and now...now, I have to figure out how to come up with money for surgery, rehab, etc. Where is the justice in this? The fairness? The peace of mind? The safety? I want a phone call, in the least, from someone of the highest rank to help me understand all of this and what anyone intends to do about it. This is not acceptable, nor is it my responsibility.
53 2021-05-28 muscle spasms Difficulty breathing; Lungs inflammed; pain in her lungs; become painful; spasms are extremely painf... Read more
Difficulty breathing; Lungs inflammed; pain in her lungs; become painful; spasms are extremely painful; Headache; Fever; her Nut Cracker Esophagus kicked in to, after the shot; her Nut Cracker Esophagus kicked in to, after the shot; This is a spontaneous report from two contactable consumers via a Pfizer- sponsored program. A 53-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. She reports she has a history of a condition called NutCracker Esophagus, it is a rare condition. She reports they did not know about it much in the 90's. She was on a number different medications to treat it but, they did not know that they were causing the issues, the medications were. It made it difficult to breath, speak or eat while coming off of the medications. The medications were causing the NutCracker Esophagus spasms then. Caller reports when she takes a drug, this will happen. She may have to wait 2 or 3 days for it to come out her system and for the esophagus to relax and the pain to go away. This also triggers some breathing issues with it. The patient's concomitant medications were not reported. Caller reports the 1st night after the shot, she had mild ones, the typically symptoms coming in the hours after the shot. She got the headache, a fever for the next day or so and difficulty going into the weekend with breathing. Caller reports she has been getting over having COVID. She had COVID 3-4 weeks before the shot, her lungs were still getting better from having covid and that her doctor did not know how long it would take for her lungs to get better. She had difficulty breathing this week, her lungs were in-flamed and still her Nut Cracker Esophagus kicked in to, after the shot. Caller reports when this had happened with other drugs before she would wait and it would come out of system but, she is worried because it was devastating on her body this week and wants to know how long would this reaction last for? Is it a matter the components coming out her system or the vaccine itself? Caller reports she got COVID. On 29Mar2021 she started to develop the symptoms and on 12Apr2021 she got a positive test. She was seen in the hospital and her symptoms were severe. Then the symptoms went down but, she was not sure if she should get the shot due still having difficulty breathing. The nurses and doctors recommended she should get the shot. She was encouraged to get the shot because they did not know when the lungs would improve. Caller reports she should have seen her doctor before getting the shot because her breathing problems are difficult and that continued into the weekend. She reports she had more inflammation in the lungs but is not sure if it is a result of the vaccine or the COVID but, it did become painful. Then, she noticed the NutCracker spasming, so she was not sure with headache that came on and with other things coming that became more extreme what was going on with the breathing. This week she has had difficulty breathing and pain in her lungs. The callers Pulmonologist office ordered a Chest X-ray for her to compare to the one done on 12Apr2021 and it was clear. She saw her regular doctor yesterday about all this. Caller reports what was not part of the COVID was the NutCracker Esophagus and it has become more problematic. She has been calling around to her doctor's office to see when this going to change, and they are not sure. Caller states if it was a regular drug it would come out in a few days but, since it is this, how long can she reasonably expect this to last? Caller reports the spasms are extremely painful and she is frustrated because of it. Would it be part of the regular vaccine or part of components that are doing this? Outcome of events headache and fever was recovered on 08May2021. Outcome of other events was unknown. Information on the lot/batch number has been requested.
53 2021-05-29 pain in extremity Major pain and headache in left arm resulted in major stroke within 24 hours
53 2021-05-30 flushing Redness, flushing on chest and neck after 15 minutes. Lasted a few hours. No other symptoms. Pre-tre... Read more
Redness, flushing on chest and neck after 15 minutes. Lasted a few hours. No other symptoms. Pre-treated with Benadryl the next dose and did fine.
53 2021-05-30 muscle spasms Severe joint pain & swelling with muscle spasm, nausea related to increased pain. PRN medication t... Read more
Severe joint pain & swelling with muscle spasm, nausea related to increased pain. PRN medication taken as directed ( normally most PRN Meds are taken once or twice a day and were increased to tolerance). Warm bath in EPSOM Salt Torodal 15 mg TID X 5 days
53 2021-05-30 night sweats, hot flush I have been having night sweats from 5-10 times per night, and hot flashes approximately hourly thro... Read more
I have been having night sweats from 5-10 times per night, and hot flashes approximately hourly throughout the day, since the second shot. This has not ebbed or flowed but unfortunately been consistent, every day and every night. I have also not had my period. I am in the age range for menopause, however, until the second shot, I had regular periods and only night sweats two days during my period. I had not had any hot flashes. It seems to have come on like a storm and most certainly could simply be peri-menopause, but it does seem strange to have been so sudden. Additionally, I have arthritis in two fingers that never really hurt much. Since the 2nd shot, it's been very painful.
53 2021-05-30 pain in extremity On May 2nd, approx 5 days after 1st Pfizer dose, I noticed a change in my mouth - roof of mouth and ... Read more
On May 2nd, approx 5 days after 1st Pfizer dose, I noticed a change in my mouth - roof of mouth and tongue especially, I have had a different taste ever since, a mineral-ish taste in my mouth since that day that has not gone away. On May 19th, the next evening after my second dose, I had intense radiating arm pain (not just like the sore arm I had the first time), more like what I imagine the radiating arm pain must be like when one suffers a cardiac event, it was very intense and scary and lasted for 15 to 20 minutes. Before and after the radiating arm/possible cardiac-like event, I noticed I was also extremely agitated before and after it happened. I was agitated to a state I am not accustomed to experiencing. It was all very unusual and unnerving for me.
53 2021-05-31 burning sensation Pt had mild rash to bilateral upper extremities/forearm w/burning sensation. Benadryl 25mg PO given ... Read more
Pt had mild rash to bilateral upper extremities/forearm w/burning sensation. Benadryl 25mg PO given @ 1248. BP 119/76; HR 76; RR 18. 1255 rash on forearms resolving. Pt was stable and no rash at 1pm & was released from vaccination site
53 2021-05-31 pain in extremity Joint Pain, 2-3x worse than her normal joint pain, her arthritis is noticeably worse, knees, lower b... Read more
Joint Pain, 2-3x worse than her normal joint pain, her arthritis is noticeably worse, knees, lower back, large joints, and her hands are the worst; Left arm instantly hurt the second she got it, it hurt before she even got out of the parking lot.; Fever; Headache; Liver Failure; Body Aches; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164; Expiration Date: 31Aug2021) via an unspecified route of administration in left arm in Apr2021, as single dose for COVID-19 immunization. Medical history included Cushing's syndrome from 2007 to ongoing, Adrenalectomy (Right) in Dec2007, ongoing Osteoarthritis (joint pain), hypersensitive to chemicals, ongoing Arthritis (joint pain), short memory. Concomitant medications were not reported. Prior Vaccinations (within 4 weeks) were None. Previously patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021) in right arm in 2021 (at age of 53-year-old) for COVID-19 immunization and also took avalox and experienced tachycardia which almost killed her (years ago). Patient stated after the second shot she had fever, body aches, headache and all the list of horrible side effects for 2 days all in Apr2021. Left arm instantly hurt the second she got it in Apr2021, it hurt before she even got out of the parking lot. Patient states what has not subsided was the joint pain. Patient states she had arthritis, Osteoarthritis caused by her Cushing's Syndrome. Patient states her medications that she uses to manage her arthritis are not stopping the joint pain. Patient stated her joint pain was 2-3x worse than her normal joint pain and also bad as it was before the vaccine and her arthritis was noticeably worse, knees, lower back, large joints, and her hands are the worst and her hands and she usually doesn't feel it much in her hands. Patient states she tested and tested to see if it was the weather and no it wasn't her joints are significantly worse and her usual treatment isn't very effective. States she was pretty sure it was from the vaccine. Patient states anyhow, she reported that her joint pain was worse after having Covid. Patient states the achiness and pain in her joints lasted and never got better, her pain was 2-3x what she was normally used to and the medicine was not making a dent in the pain level. Treatments were Occasional Tylenol. CBD (cannabidiol) and THC (tetrahydrocannabinol), but they are not working. Patient stated she rarely takes Tylenol in case of Liver Failure in Apr2021. Patient states her body rejects chemicals and she has to eat organic food. The outcome of event liver failure was unknown, joint pain and arthritis aggravated were not recovered, while remaining events were recovered in 2021. Batch/Lot number was obtained. Further information has been requested.
53 2021-05-31 pain in extremity She is feeling sick; her arm was very sore; headache; she doesn't feel good and is tired; she doesn'... Read more
She is feeling sick; her arm was very sore; headache; she doesn't feel good and is tired; she doesn't feel good and is tired; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable 53-year-old female Nurse reported for herself. A 53-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number: EL9265 and expiration date: 31May2021) via an unspecified route of administration, administered in left deltoid on 29Jan2021 at 10-10:30am (at the age of 53-year-old) as single dose for COVID-19 immunization. The patient medical history included a shingles in Nov2020, breast cancer, it is non-metastatic triple negative and Covid virus where she had headache, was sick for 2 full weeks and then on the 3rd week she felt better. The patient's concomitant medications were not reported. The patient did not had allergies. The patient did not have any illness at time of vaccination. On 30Jan2021, the patient's arm was sore and very sore when she touches it the first day after, she put a cold compress and felt much better the next day and headache is felt like when she had covid previously and feels like she is at the tail end of having the virus. She doesn't feel good and feeling so tired because of all of this. The patient has taken treatment of Excedrin migraine for the headaches also taken Tylenol and when she got desperate, she took a sumatriptan, a product used for migraines. The patient did not diagnose with COVID-19 since the vaccination. The outcome of event arm was very sore is recovering. The outcome of events Headache and doesn't feel good and tired is not recovered. Follow-up attempts are completed. No further information is expected.
53 2021-06-01 pain in extremity, feeling hot pain all up the arm/As time passed the pain progressed up her arm. She couldn't straighten arm at al... Read more
pain all up the arm/As time passed the pain progressed up her arm. She couldn't straighten arm at all/When she lifts her arm up, it is still sore/her right arm wrist also has pain; now she also has pain in her right wrist/pain has started to increase in her left arm wrist/her right arm wrist also has pain; swelling at the injection site; left shoulder inoculation site edema/edema is minimal; left ear was burning; left eye had floater; left hand and wrist were double the size of right hand/it was so swollen it was a bite/because of the swelling. She couldn't even bend her knuckles at all; swelling in the right wrist/wrist doubled the size of right hand/it was so swollen it was a bite; entire arm where the vaccine was given was red and swollen/swelling in her left arm has increased; entire arm where the vaccine was given was red and swollen.; arm was warm; she has cried; intramuscular pain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0182), intramuscular at the age of 53-year-old administered in arm left on 06May2021 10:40 at single dose for covid-19 immunisation. Medical history included chronic anemia, pulmonary embolism in both lungs (doesn't remember the years but she had 4 or 5 of them/maybe between 2016 and 2019), didn't have a bladder from Apr2020 (cystoscopy performed in Apr 2020), dehiscence of wounds, gastric bypass from Jul2007, two major blood clots in right arm from 2019 (because of infiltrated IV. One was 7mm and one was 8mm. A piece broke off of one of them within 24 hours and went into right lung), Smoker, allergy to antibiotics, slightly topical itch reaction to Morphine, cat scratch infection, had a reaction to IVP dye for kidney scan where her eyes started swelling. Concomitant medication included gabapentin (NEURONTIN) taken for left knee nerve pain from Mar2021 and ongoing. The patient previously took Doxycycline and experienced anaphylactic reaction, morphine and experienced slightly topical itch reaction. She received her first Pfizer COVID19 Vaccine on 06May2021 which was a Thursday. Everything was fine. Shot was in left arm. Wednesday, last week, which was six days later she woke up with her entire left hand and wrist doubled the size of right hand on 12May2021. A friend of hers is her in home nurse because caller has underlying health issues. They thought because it was so swollen it was a bite. Caller did Benadryl and RICE treatment. As the day progressed, she had pain all up the arm on 17May2021. She had an appointment with physical therapy. They said to get to the hospital. Her nurse met her for lunch and caller's arm was warm in May2021 and her nurse said to get to the ER. They wanted to rule out a blood clot. They didn't want to admit her, but she had severe issue with her arm that day. She was given pain medication, Benadryl, and had CT scan to rule out blood clot in ER. She couldn't move her neck to the left. She was there 8 hours. While there, her left ear was burning (on 12May2021) to the point it felt someone was ripping it off. In her left eye she had floater on 12May2021, like black fuzzy lines. Everything was on the left side. She didn't hit anything in the time between receiving the injection and 6 days later. She had not done nothing out of her normal routine. It is too much of a coincidence that this is the only thing she has had in the left arm. For 2 or 3 days since last Wednesday the entire arm where the vaccine was given was red and swollen in May2021. She didn't have an immediate side effect, but 6 days later she had a great amount of side effects. She can't say it is the vaccine. She has had a flu shot every year and pneumonia shot every 5 years with no side effect. She is anaphylactic or resistant to every oral antibiotic. Even with IV antibiotics there are only certain ones that can be use, but she has to be pretreated with 50mg of IV Benadryl. She was on Doxycycline all last summer oral and IV. After 4 weeks on it she was sent home with a temp medline for IV infusion. Within 3 hours of her giving herself the next dose she had an anaphylactic reaction. Her body does not immediately react to any side effects or adverse reaction. It can be days out and it hits all of a sudden. On last Wednesday she woke up around 7AM. She felt like it woke her up because of the swelling. She couldn't even bend her knuckles at all. As time passed the pain progressed up her arm. She couldn't straighten arm at all. Everything was on that Wednesday and on the left side. She had full range of motion on the right side. The hospital said it was intramuscular and she read that could possibly be side effect. This was her first dose. Left hand and wrist were double the size of right hand: It resolved. She noticed it around 7AM as the day progressed the swelling went down a little bit. That is when the arm started hurting and the swelling would come back. The swelling wasn't as significant as it was first thing in the morning. She has pictures she can provide if needed. Pain all up the arm: the pain has resolved except for the top of the arm where she received the vaccine. When she lifts her arm up, it is still sore. It wasn't sore the first 2 to 3 days or immediately following the inoculation. It is still very mildly sore. They also did an ultrasound when in the ER. At home she takes, not for this issue, Gabapentin 3 times a day. It was just filled and is in the pharmacy vial and she doesn't have NDC, lot, and expiry. Caller clarified that it is Neurontin 300mg not Gabapentin. She has been on Neurontin since Mar2021. She takes it for left knee nerve pain. For the pain meds she was given in the ER and the Benadryl she doesn't have NDC, lot, or expiry. The hospital administered 100mg of Benadryl. When they did the CT scan they did it with contrast. 40 years ago she had a reaction to IVP dye for kidney scan where her eyes started swelling. Anytime she has contrast solution she is always treated with 50mg of IV Benadryl. She has a slightly topical itch reaction to Morphine. In the ER, they gave her 40mg of IM morphine because they couldn't get a line going. She basically has no veins. They gave her 50mg of Benadryl subcutaneously in the inner area. Then before the CT with contrast, they gave her another 50mg of Benadryl. What she took at home was off brand. It is called Banophen Diphenhydramine HCI 25mg antihistamine. She took one when the reaction happened. The manufacturer is Major. NDC: 09045551-59. When providing NDC caller states, "Come on eyes." Lot number: P121325. Expiry: Aug 2022. Caller just found a sugar cookie from Panera Bread to eat. She was in (withheld) in mid October to late October. Unfortunately when she was down there with her best friend her cat scratched her and caller ended up in the hospital because of cat scratch infection. Even though they were very cautious and following all the CDC guidelines and wearing mask when she came home for 5 days she had many COVID symptoms. She went for a rapid test and it came up negative. She has been tested 15 times since last year because she has had so many surgeries. The reason she got the vaccine was with her underlying health conditions she doesn't want to die. What is interesting is her husband and son both after she felt ill coming home had the same symptoms she did. She is scheduled to get her next dose 27May2021. Is that normal to be scheduled 3 weeks apart? Her greatest concern is her nurse provider is not familiar with her. Her GI doctor and orthopedic surgeon said she should be ok. She wants to receive both as recommended. Her concern with the second vaccine is if the side effects that she experienced could be dramatically worse or result in a horrible outcome. When she spoke to the physician and the nurses and the medical care team they said there are no studies or reports where the vaccine is causing blood clots and what she was experiencing was not associated with the vaccine. When she looked up the vaccine, it said that intramuscular issues could be a rare side effects. Her thought was that it wasn't reported that it hasn't happened. Could intramuscular issues be a rare side effect? Caller clarified that she does not have the Doxycycline or any other antibiotics that she is resistant to or had reaction with to provide NDC, lot, and expiry. The last time she had it was when she had the temp medline put in. She had the reaction and spoke to the infectious disease doctor only in hospital. She threw all the vials and all the bags away. She torn up the lot numbers. The actual bottles she soaked them and then flushed the labels down the toilet. She has chronic anemia. It has been brought to her attention lately that she has critically low iron saturation. Low saturation should be 18 and her iron saturation level was a three. She had the blood test on the same day of the vaccine on 06May2021. On the 7th she had iron infusion. The vaccine was given at 10:40AM. The blood work was drawn at 02:40PM. The iron infusion was at 9:30AM on 07May2021. She received one unit. Adds she previously reported she had gotten the Pfizer COVID 19 vaccine and six days later she had severe side effects. States she was encouraged by her health care professional to go to the ER to rule out a blood clot which she did and the result was negative. Adds when she had the first dose of the vaccine 06May2021, intramuscular in the left shoulder; she had no side effects or anything. Six days later her left hand was swollen to double the size of the right had. She took a 25mg Benadryl that did nothing, which she previously reported. Adds at lunch yesterday she spoke to a friend who is an in home care nurse who has taken care of her before because of her other medical problems; and she encouraged the caller to do RICE treatment; rest, ice, compression and elevation for her wrists. This friend saw the hand at lunch and noticed that the caller was unable to straighten the left elbow and arm; she had great pain in the left elbow and from the hand up the arm. All of these events were previously reported. Caller mentions she is in so much pain and her symptoms are getting worse. New events reported today include the pain has started to increase in her left arm wrist; swelling in her left arm has increased. Caller mentions the physical therapist saw the edema especially on the left shoulder at the vaccination (inoculation) site on 17May2021 and said there is still swelling and she had not noticed this before. Caller clarifies later that day around 1700PM 17May2021, the caller attended a physical therapy treatment and the therapist noticed swelling at the injection site on 17May2021 which was not previously reported. Adds as the day went on yesterday, her right arm wrist also has pain; since yesterday through last night and today it has been at a 10. Adds she has cried in May2021. Mentions she feels she has limited use of her fingers that she noticed yesterday when she had the wrist pain; even picking up things or trying to chop chicken, she can't; she doesn't think she mentioned particularly the left wrist yesterday. Her main concern today is that the pain in her left wrist has increased and now she also has pain in her right wrist on 17May2021. Caller adds she put muscle rubs on; and ice. Her pain in her wrists has not responded to the Gabapentin. She applied three different topical solutions with no improvement in her pain: Generic muscle rub from store; Natureplex Ultra Strength muscle rub; NDC 67324002-01; Jul2022;Topical 5% pure lidocaine cream; Lot 20G13C1; Jul2022; OTC from the pharmacy, no box. Voltaren Gel; Dec2019; lot WN791; unable to locate NDC due to pain in her wrist. Adds the swelling on both wrists is minimal but the pain is incredible; excruciating. Just the edema is minimal; she has kept ice on it on and off; 20 minutes on and off. Adds she has never had pain like this before. Caller mention she did speak with doctor yesterday. Adds she was greatly upset when they told her after she had explained all of her symptoms, that intramuscular joint pain had been detected in May2021. The events results in Emergency Room Visit. The patient underwent lab tests included blood test: unknown results on 06May2021, Iron saturation: low (Low saturation should be 18 and her iron saturation level was a three) on unknown date, CT scan (to rule out blood clot): unknown results, ultrasound: Unknown results, COVID test: negative. The outcome of event left ear was burning and left eye had floater was recovered on 12May2021, the outcome of event Swelling of wrists, Vaccination site oedema and Wrist pain was not recovered and other events was unknown.
53 2021-06-01 pain in extremity Right ear pain, shooting/stabbing, around 8:40 pm May 31. Woke from sleep around 4 am June 1, severe... Read more
Right ear pain, shooting/stabbing, around 8:40 pm May 31. Woke from sleep around 4 am June 1, severe pain right ear. Walked around 5:20 am, pain outside and top of left foot. Right side ear pain continued through morning, as did foot pain. Foot pain eased around 10 am. Scalp on right side hurt too much to brush hair. Eye pain/discomfort started before noon. Felt like bruise and burning, especially bottom lid and inside half of eye. Went to ER around 2. Ear pain had lessened, only jolts of pain, certain facial expressions exacerbated pain. Eye discomfort more prominent. Scalp most painful right side, rear half.
53 2021-06-02 weakness Chest pain and pressure, back pain and severe shortness of breath. Weakness and brain fog. The sho... Read more
Chest pain and pressure, back pain and severe shortness of breath. Weakness and brain fog. The shortness of breath has lasted 2 weeks and caused me to not be able to do activities.
53 2021-06-02 numbness Complete numbness of right arm within 24 hours of vaccine. 4 weeks following vaccine 20% numbness ... Read more
Complete numbness of right arm within 24 hours of vaccine. 4 weeks following vaccine 20% numbness remains in forearm (starting at elbow) and part of right hand (thumb and index finger)
53 2021-06-02 tremor, slurring Hemiplegic migraine; Forgetful; Peeing more often; Heavy tongue; Slurred speech; Aura; Bleary vision... Read more
Hemiplegic migraine; Forgetful; Peeing more often; Heavy tongue; Slurred speech; Aura; Bleary vision; Left eye twitching on and of; black and blue eye; Hands shaky; swollen black and blue eyes; Depth perception problem on right side; Headache; Fatigue and very tired; This is a spontaneous report from a contactable patient. A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: unknown) via unspecified route of administration on 04Mar2021 at 10:30 am (at the age of 53- years) as a single dose for COVID-19 immunisation. The patient's medical history included asthma, seasonal allergy, Transient Ischemic Attack (TIA) in 2014 and migraine. The concomitant medication includes erenumab aooe (AIMOVIG) for migraine from unknown dates. Patient previously took botulinum toxin type A (BOTOX) for migraine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Mar2021 at 08:00 am, the patient experienced fatigue for 1-3 days, headache, until she had gone to urgent care. The patient also reports swollen black and blue eyes, tiredness, left eye twitching on and off, blurred vision, slurred speech, was forgetful, depth perception problem on right side and heavy tongue, hands shaky, aura, peeing more often (sometimes she had to sit longer) and hemiplegic migraine. It was also reported that, the events migraines and headache she had after the vaccine was intolerable. At the time of report the events of mild headache and blurred vision was ongoing. The adverse events resulted into healthcare professional office/clinic visit and emergency room/department. Therapeutic measures for the reported adverse events included treatment with metoclopramide, methylprednisolone and "nr" from unknown dates. The clinical outcome of the events of fatigue, headache, swollen black and blue eyes, tiredness, left eye twitching on and off, blurred vision, slurred speech, was forgetful and heavy tongue, hands shaky, aura, peeing more often and hemiplegic migraine was reported as recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Updated reporter details (reporter name, for correspondence contact in slide#2, Health care professional leave blank; Protect confidentially and Correspondence contact was checked). Patient details added (Patient's first name and age/units). For concomitant drug "amogiv" was considered as typo and coded as Aimovig. Concomitant therapy leave blank since the concomitant drug was coded via WHO drug in product tab already. Deleted duplicate reported Indication of BNT162B2. Lot# UNKNOWN was removed from dosage regimens tab. Best doctor/Health care professional information such as phone number and email were added in vaccine administration tab. Treatment received was ticked as Yes for events. Physician Office Visit and Emergency room visit were checked. "Depth perception problem on right side" was added as AE.
53 2021-06-03 pain in extremity Upper back pain; Leg pain, foot pain; Headache; This is a spontaneous report received from a contact... Read more
Upper back pain; Leg pain, foot pain; Headache; This is a spontaneous report received from a contactable physician. A 53-year-old non pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN5318) intramuscularly on the left arm on 31Jan2021 (at the age of 53-year-old) at 12:00 PM, second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) intramuscularly on the left arm on 28Feb2021 at 12:00 PM (at the age of 53-year-old) as single dose for COVID-19 immunisation. Medical history included systemic lupus, migraine, seasonal allergies and allergy to bactrim. Concomitant medications included zolpidem (MANUFACTURER UNKNOWN), SINGULAIR and UBRELVY. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccine. After the first dose of vaccine, on 01Feb2021, the patient experienced headache, leg pain, foot pain and upper back pain. After the second dose of the vaccine, the events headache, leg pain, foot pain and upper back pain were worsened. The patient received TYLENOL as a therapeutic measure for the events headache, leg pain, foot pain and upper back pain. The clinical outcome of the events headache, leg pain, foot pain, upper back pain was not resolved and the patient was still complaining about her symptoms at the time of this report. No follow-up attempts are needed. No further information is expected
53 2021-06-04 tingling, numbness face and head went numb and were tingling; face and head went numb and were tingling; Eyes felt swol... Read more
face and head went numb and were tingling; face and head went numb and were tingling; Eyes felt swollen/numb; Eyes felt swollen/numb; Left arm and both hands were numb even longer; This is a spontaneous report from a non-contactable female consumer. A 53-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205, Expiration date: unknown), via unspecified route, administered in left arm on 04Mar2021 (at the age of 53-year-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history include heart- mitral valve prolapse, pre ventricular contractions, and concomitant medications were not reported. The patient had history of Prilosec induced drug hypersensitivity, cephalexin induced drug hypersensitivity and sulpha drug allergies. The patient was not tested positive for covid-19 prior to vaccination. On 04Mar2021, 02:15 pm, 15 minutes after the vaccination, the patient experienced face and head numbness and were tingling. Eyes felt swollen/numb. This lasted 4 hours. Left arm and both hands were numb even longer. The reporter assessed all events as non-serious. The outcome of the events was recovered on mar2021. No follow-up attempts possible. No further information expected.
53 2021-06-06 feeling hot welts began to appear on arm and shoulder within about 1.5 hours -2 hours after injection. Hot, swo... Read more
welts began to appear on arm and shoulder within about 1.5 hours -2 hours after injection. Hot, swollen, welts
53 2021-06-06 pain in extremity On February 12th I had the biopsy showed two cancerous masses in my breast. I had a mastectomy done... Read more
On February 12th I had the biopsy showed two cancerous masses in my breast. I had a mastectomy done. I also had headaches, left arm pain and total body aches.
53 2021-06-07 weakness, tingling, numbness Site: Swelling at Injection Site-Medium, Systemic: Diarrhea-Medium, Systemic: Lymph Node Swelling-Me... Read more
Site: Swelling at Injection Site-Medium, Systemic: Diarrhea-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Vomiting-Medium, Additional Details: patient reported diarrhea & vomiting which made her feel weak and dehydrated that she went to ER. Pt also observed swelling under her arm, numb and tingling in the arm.
53 2021-06-07 numbness Systemic: Numbness (specify: facial area, extremities)-Severe
53 2021-06-07 migraine I couldn't breathe and I felt horrible. I went to the ER. I was hospitalized for 3 days. I had a mas... Read more
I couldn't breathe and I felt horrible. I went to the ER. I was hospitalized for 3 days. I had a massive migraine. When I went home, I couldn't walk. I saw my doctor. They said I had a horrible reaction to the vaccine. I was still sick a week later. I called my doctor again. I went back to the hospital for another X-Ray. They told me had I had deflated air pockets in my lungs. My doctor thought I had pneumonia. I was prescribed two inhalers. The combination of both inhalers provided some relief. I take a lot of supplements to try to give myself relief as well. I still get really winded most days - its sometimes difficult to walk up the stairs, walk to the parking lot, or move around at work & most places. I'm going back to the doctor in July.
53 2021-06-08 pain in extremity Symptoms: Pain, swelling, stiffness in both hands, fingers, elbows, ankles and feet with difficulty ... Read more
Symptoms: Pain, swelling, stiffness in both hands, fingers, elbows, ankles and feet with difficulty to use and walk at times thought would get better, after a few weeks went to PCP on March 9, 2021 due to worsening symptoms. Referred to Rheumatologist. 1st visit March 19, 2021 started on Hydroxychlorquine for Rheumatoid Arthritis and labs ordered. 2nd visit May 11, 2021 started on Methotrexate due to ongoing symptoms. 3rd scheduled for August 26, 2021 with labs to be done every 3 months. Continue to have issues daily and does affect my ability to continue with my prior way of life due to fatigue, pain and swelling with stiffness.
53 2021-06-08 tingling, feeling hot, flushing, numbness About an hour after receiving the vaccine, I started to feel warm and started having trouble swallow... Read more
About an hour after receiving the vaccine, I started to feel warm and started having trouble swallowing. Thirty minutes after that I started feeling flush. I was having more difficulty swallowing. Below my nose to my chin started to tingle and it felt numb. We drove to the ER. I called my PCP before entering, my doctor told me to go in to the ER if the feeling continued. I went into the ER and they saw me immediately. I was triaged very quickly and maybe 30-45 minutes later, I felt normal again. My condition was referred to as a mild adverse reaction to receiving the vaccine.
53 2021-06-08 tingling tiredness; back became inflamed.inflammation in her lower spine; lower back pain; annular fissures; ... Read more
tiredness; back became inflamed.inflammation in her lower spine; lower back pain; annular fissures; tingling sensation; allergic reaction to the second one; she did the 2nd dose of the Pfizer COVID Vaccine in her right thigh; face got swollen; felt dizziness; headaches; had a half an apple sized swelling in her leg for a couple of days; left side arm was weak; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received a BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in Right thigh on 02Apr2021 10:30am (at the age of 53 years) as 2nd dose, single dose for covid-19 immunisation. Medical history included brain surgery on an unspecified date in 2014 to an unknown date, facial reconstruction on an unspecified date in 2015 to an unknown date, vestibular condition from an unknown date and unknown if ongoing, muscle flap operation on an unspecified date in 2015 (Transfer from her thigh in 2015 for her left cheek so her face after brain surgery. Patient had Gracilis free flap of her right thigh and had a new cheek and had calf nerves grow back). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot: EN6208) on 12Mar2021 10:30am for covid-19 immunisation and experienced dizziness, headaches, left arm, it was swollen, bell's palsy, tingly feelings, tiredness and slurring of speech. The report received as, the patient 1st dose of the Pfizer COVID Vaccine was at 10:30am on 12Mar2021 and the 2nd dose was at 10:30am on 02Apr2021. The patient had brain surgery which saved her life, the HCP said maybe patient should rethink going for the 2nd dose of the Pfizer COVID Vaccine; patient followed up with neurologist and everybody weighed in the benefits outweigh the risk and patient was got the 2nd dose. The patient states she was one of those people who had an allergic reaction to Pfizer, she had both doses. Patient states after a while, the doctor said yes the caller may want to consider getting the second dose. The patient states the benefits outweighed the risk, but the other recommendation, which was brilliant, they said get it in her leg, she did have an allergic reaction to the second one, but not same way. The patient did the 2nd dose of the Pfizer COVID Vaccine in her right thigh and had inflammation in her lower spine after that; Caller states it was the characteristic tiredness. The patient how the shot feels like a shot in the arm or a horse kicked you, states she feels like the Pfizer COVID vaccine felt like a shot in the arm but never felt that pain and had swelling and had a half an apple sized swelling in her leg for a couple of days; The patient also did not feel the face drooping because the 2nd dose of the vaccine was done in her leg. The patient started to get really bad lower back pain and went to the HCP and was maybe sitting down too much; The patient does not have proper posture sometimes and does not want to stand. The patient saw a holistic HCP which is a chiropractor, and that HCP did not touch her spine; The patient saw that HCP on 14Apr2021, and she was diagnosed with annular fissures and they thought patient had a slipped bulging disc and never had that before but had a tingling sensation and they said to take a few weeks to recover. The second time Pfizer COVID vaccine targets places that are weak and that is the weak part in her body regarding her spine. Tthough she went a week and a half later, she thought it was too much zoom fatigue, but the doctor said it sounds like annular fissures. The patient keeps seeing her HCP and has recovered and has to say as soon as they said this is probably related because patient thought the he patient left side arm was weak and the weak side of the face that was where the transfer of nerves was and that had gotten swollen and did not work, she felt dizziness, headaches, she knew what to expect, but she got worried when she was getting a little bit more droopier than usual. The patient was fine and would say patient was better and thinks patient was completely recovered and from time to time still just feels a little tingling still and did not have that before; States because of her brain surgery, the neurologist said patient can tingle independently and does not normally tingle in that area but the patient was better and 90 percent better; The HCP said to give 12 weeks to recover and will see her again next week and sees the HCP every 2-3 weeks, so this was minor. Said they needed the discs to get fluid in them, so they are healing; The neurologist was thinking of those people that as we all learn to live alongside covid she does things to avoid exposure to covid. States the HCP told her if she gets the live version of the covid virus due to how she reacted to the vaccine how would it protect her and obviously it protects her but could give her bells palsy again. The patient back was inflamed, fortunately, there was no slipped disc or bulging discs, it was just annular fissures. It was locally the right thigh, lower back, left arm, left side of the face and it's kind of thematically, spatially related. The patient underwent lab tests and procedures which included blood glucose; computerised tomogram; magnetic resonance imaging head all were normal on an unspecified date. Outcome of the events was unknown.
53 2021-06-09 weakness a warm and thirsty throat; a warm and thirsty throat; dizziness; nausea; pain around spleen; tiredne... Read more
a warm and thirsty throat; a warm and thirsty throat; dizziness; nausea; pain around spleen; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: EN6206) via an unspecified route of administration administered in Arm Left on 10Mar2021 09:30 (at the age of 53-years-old) as single dose for covid-19 immunization. The patient's medical history included thyroid cancer, chronic back pain, thoracic carcinoid and known allergy to green vegetables and some type of MRI or CT Contrast. The patient's concomitant medications included levothyroxine at 100 mg. On 10Mar2021 at 09:45, after been vaccinated patient started having a warm and thirsty throat. Within next hour, started feeling severe dizziness, nausea and pain around spleen. Next, the patient started feeling tiredness and weakness. The patient did not receive any treatment for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
53 2021-06-09 slurring, bell's palsy, tingling Bells Palsy/ little bit more droopier than usual/facial droop; allergic reaction; blood pressure wen... Read more
Bells Palsy/ little bit more droopier than usual/facial droop; allergic reaction; blood pressure went up to normal, which was not normal for her, as its very low/ 120/70, which was normal, but not great for her and was high for her; dizziness; headaches; tingly feelings/still just felt a little tingling still; got the shot in her left arm and it was swollen; slurring of speech; face got swollen and definitely impacted her speech; This is a spontaneous report from the contactable consumer (patient herself) and physician via Medical Information. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 12Mar2021 at 10:30 at the age of 53 years old (Batch/Lot Number: en6208, Expiration date: unknown) as the 1st dose, single dose for COVID-19 immunization. Relevant medical history included brain surgery in 2014 and facial reconstruction in 2015, further reported as transplant or transfer from her thigh in 2015 for her left cheek, so her face after brain surgery in 2014 was reconstructed in 2015 and she could have a symmetrical face; and vestibular condition from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was asking for accommodations Pfizer would provide to advocate for people working from home to minimize their risk of exposure to COVID-19. The patient was a teacher, who taught languages and she often had students with hearing disabilities and had to take her mask down so they could see her lips. She reported that she was fully vaccinated but was concerned about being exposed to people who haven't been vaccinated and asked if there were any recommendations or accommodations being offered by Pfizer to assist her with trying to work from home. The patient received her second vaccine dose on 02Apr2021 at 10:30 AM with lot number: ep7533. The patient reported experiencing Bells Palsy after being vaccinated on an unspecified date in Mar2021 and was asking how long or much protection she had against COVID-19, because her understanding was that because she reacted to the vaccine in this way, if she got COVID-19, she might experience the same type of reaction to COVID-19 and she didn't want to experience Bells Palsy again. The patient reported that she had "distinct reactions" to both the first and second doses and was told by her neurologist that because its a live virus and she had a reaction to it, she had the potential to get the same symptoms from COVID-19. The patient further asked if the Pfizer-BioNTech COVID-19 vaccine could shed the virus and was provided with references. Upon follow up, the patient stated that she was one of those people who had an allergic reaction to Pfizer, she had both doses. The patient stated she thought she was better off vaccinated. After the first dose, she did have the characteristic symptoms and people thought she was having a stroke; she was fine, but it freaked out her husband. She stated she should know as she has had facial reconstruction and did have it in the left arm. The patient got vaccinated at a clinic in a neighboring area and called her primary care doctor. The patient stated her blood pressure went up to normal on an unspecified date in Mar2021, which was not normal for her, as its very low. She stated she had the characteristic dizziness, headaches, tingly feelings, and Bells palsy on an unspecified date in Mar2021. She stated her primary care doctor asked her where she got the shot, she said in her left arm and it was swollen on an unspecified date in Mar2021. The patient stated she did go to the emergency room, which was scary. She stated she spent a year and a half trying to stay away and stated everybody got to see her at her baseline, which was a semi-symmetrical face. The patient stated after a while, the doctor said yes the patient might want to consider getting the second dose. The patient stated that because of the brain surgery, she was able to quickly write an email to many doctors who could weigh in. The patient stated that the doctor said the benefits outweighed the risk, but the other recommendation, which was brilliant, they said to get it in her leg. The patient stated she did have an allergic reaction to the second one, but not the same way and stated it was the characteristic tiredness on an unspecified date. The patient stated her husband got Moderna and was out a whole day. The patient also stated she had the slurring of speech, the face, and it took a couple of days to go away, but it did and then she was back to her as-symmetrical face as she could have. The patient stated the second time though she went a week and a half later, she thought it was too much zoom fatigue, but the doctor said it sounded like annular fissures. The doctor then asked if she did get her vaccine and she told the doctor she did. The patient didn't know if that's a thing; she thought she would bring that up, because her back became inflamed. The patient further stated that for the first dose, her face got swollen and definitely impacted her speech, which promoted her to go to the emergency room. She stated she felt dizziness, headaches, she knew what to expect, but she got worried when she was getting a little bit more droopier than usual. The patient stated that for the second time (dose), it took about 12 weeks to recover and she had been able to recover; she stated her back was inflamed and fortunately, there was no slipped disc or bulging discs, it was just annular fissures. The patient stated that a doctor in the area said that it made sense; it was locally the right thigh (second dose) - lower back, left arm (first dose) - left side of the face, and its kind of thematically and spatially related. The patient stated she got this at the hospital way back in Mar2021. The patient stated they did a brain magnetic resonance imaging (MRI), computerized axial tomography (CAT) scan, and diabetes test. The patient stated that to live the pandemic, she was worried that she had eaten too many cookies, but everything came back normal, as normal for her. She stated clearly she had got issues, but they were issues long before the vaccine. The patient was one of those people who definitely had something happening and people were saying no that can't be. She stated it was evident that yes, it was Bells palsy, she had never had. She stated she had had facial paralysis that was taken care of by Gracilis surgery. She stated it was experimental when she did it, but it's not so experimental anymore after her brain surgery. The patient stated Pfizer might want to hear her happy ending. The patient stated her daughter got Pfizer a few weeks prior reporting, so she's fully vaccinated and they had their first hug since 2020 and it was just an emotional thing. The patient stated she followed up with a neurologist and she was going to see him in the middle of June, she sees him every couple of months, mostly for work accommodations. The patient stated that the idea being if Bell's plays was her reaction from a dead form of the virus, even getting sick with it would indicate that this could happen to her in a different context. She stated that since she's a teacher, it's a good thing for her to know as she went back to work, she'd been able to work online, she'd probably not going to be able to argue for that unless her doctor argued for her. She stated her neurologist would know more of the story. She stated she saw her primary care doctor for her annual physical after she was fully vaccinated. She stated the follow-up was with a neurologist. The patient further stated she was fine and was not fine at the time of the reported events, but it was better to get the vaccine than to get COVID-19. She stated her mother and sister were all vaccinated. The patient further stated that on her 1st dose, she felt like someone had taken a hammer to her head and was headachy and not feeling great and was taken to room to wait; stated her blood pressure was taken and it was 120/70, which was normal, but not great for her and was high for her as she normally had a very low blood pressure. She went home and might be an hour after getting home, she realized her face was swelling and got the 1st dose of the vaccine to the left side of her upper arm and her face started to swell and she did have brain surgery in 2014 and stated in 2015, she had Gracilis free flap of her right thigh and had a new cheek and had calf nerves grow back together again and had to learn to walk again at that time, because they spliced the nerves, which was not a transplant but a transfer. The patient stated the flap made her face back symmetrical as possible and used her face and able to drink coffee, smile and keep food in her mouth; stated her face kind of drooped anyway, but this was more than that. The patient stated her husband said she had been traumatized and just to relax and she kind of got Bell's Palsy, which she had never had before and got diagnosed with it and was swollen and started having slurred speech; stated she had facial droop and got to the hospital, which was emotional and getting the Pfizer COVID vaccine was emotional and she was trying not to add to her issues. The patient stated was able to see formal field and everyone thought she was having a stroke, but she was not having a stroke and everybody said it couldn't be the Pfizer vaccine; it had to be something else. The patient stated her healthcare professional (HCP) asked about her baseline and her husband had photos of her and she was not normally symmetrical in her face. They did scans, MRI brain and everything checked out normal, which was a blessing and several HCPs were getting results and she did not have diabetes. The patient stated she was trying to be careful during the pandemic with her health and they kept her in the emergency room from 11-12 pm to 8:00 pm and she was saying she was hungry and thirsty and did not know they did not want her to eat or drink and wanted to make sure she could swallow and she was ok swallowing, but had dribble on the left side of her face with the drooping. She stated she saw her primary HCP before she went to the emergency room and he asked which side she got the Pfizer COVID vaccine on and that was kind of where he had the idea that this could be related to the vaccine and the reported events occurred so close to when the vaccine was administered and the reported events occurred immediately after the vaccine; she stated her blood pressure was ok and she ate a cookie and maybe had not enough breakfast and got worse. The patient stated her slurred speech and Bell's palsy lasted a day or two and everything went back to normal, stated because she had brain surgery, which saved her life; the HCP said maybe she should rethink going for the 2nd dose of the Pfizer COVID Vaccine; she followed-up with her neurologist and everybody weighed in the benefits outweigh the risk and she got the 2nd dose. She did the 2nd dose of the Pfizer COVID Vaccine in her right thigh and had inflammation in her lower spine after that; stated how the shot felt like a shot in the arm or a horse kicked you; stated she felt like the Pfizer COVID vaccine felt like a shot in the arm, but never felt that pain and had swelling and had a half an apple sized swelling in her leg for a couple of days; stated she also did not feel the face drooping, because the 2nd dose of the vaccine was done in her leg. With the second dose, she started to get really bad lower back pain and went to the HCP and was maybe sitting down too much; stated she did not have proper posture sometimes and did not want to stand. She stated she saw a holistic HCP, which was a chiropractor and that HCP did not touch her spine; stated she saw that HCP on 14Apr2021 and she was diagnosed with annular fissures and they thought she had a slipped bulging disc and never had that before, but had a tingling sensation and they said to take a few weeks to recover. She stated she kept seeing her HCP and had recovered and had to say as soon as they said this was probably related, because she thought the Pfizer COVID vaccine targeted places that were weak and that was the weak part in her body regarding her spine; stated her left side arm was weak and the weak side of her face that was where the transfer of nerves was and that had gotten swollen and did not work. She stated she was fine and would say she was better and thought she was completely recovered and from time to time still just felt a little tingling still and did not have that before; stated because of her brain surgery, the neurologist said she could tingle independently and she did not normally tingle in that area, but she was better and 90 percent better; stated the HCP said to give 12 weeks to recover and she would see her again next week and would see the HCP every 2-3 weeks so this; said they needed the discs to get fluid in them so they were healing; stated her daughter got the Pfizer COVID Vaccine and is doing well. The patient underwent further lab tests and procedures, which included Brain MRI, CAT scans, and diabetes test, which were all normal on an unspecified date. The patient was recovering from the event "tingly feelings/still just felt a little tingling still," while she recovered from the rest of the events on an unspecified date.
53 2021-06-09 migraine Symptom start date (6/09) Symptom start time (9:30PM): Chills, headache/migraine, body aches, loose ... Read more
Symptom start date (6/09) Symptom start time (9:30PM): Chills, headache/migraine, body aches, loose stools (6/10)
53 2021-06-09 tingling patient reported experiencing tingling sensation down on left arm after getting Pfizer vaccine. She ... Read more
patient reported experiencing tingling sensation down on left arm after getting Pfizer vaccine. She has a history of fibromyalgia. Patient was in observation area for 30 minutes without resolving the symptoms to baseline. Followed up with patient, after one hour, she still experiences the symptoms. Patient was told to follow up with urgent care or clinician if symptoms do not resolve.
53 2021-06-10 bell's palsy 32 day after vaccination I developed Bell's Palsy.; This is a spontaneous report from a contactable ... Read more
32 day after vaccination I developed Bell's Palsy.; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0158; Formulation: solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 24Apr2021 13:30 as 2nd dose, single dose for covid-19 immunisation. Medical history included diabetes. Patient had known allergies to penicillin. Concomitant medication included metformin. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: unknown, Formulation: solution for injection), via an unspecified route of administration, administered in arm right on 03Apr2021 at 13:15 as single dose for covid-19 immunisation with no adverse effect. Patient developed bell's palsy 32 day after vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received metformin within 2 weeks of vaccination. Patient developed bell's palsy 32 day after vaccination. These adverse event result in emergency room/department or urgent care. Patient was treated with anti viral prescription. Patient was not diagnosed with covid-19 prior to vaccination and since the vaccination, patient has not been tested for COVID-19. The outcome of the event was not recovered. Follow up needed, further information has been requested.
53 2021-06-10 bell's palsy Her face drooping on one side/when brushing teeth water dribbled out of side of her mouth/ Bell's pa... Read more
Her face drooping on one side/when brushing teeth water dribbled out of side of her mouth/ Bell's palsy; Her jaw locked up, when / she could not open her mouth wide enough to eat; Her tongue felt like it was burnt and her food tasted funny; Her tongue felt like it was burnt and her food tasted funny; Her neck hurt; This is a spontaneous report from a contactable consumer (Patient herself). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 (at 53-years age) as 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26May2021 a week after the vaccination patient experienced her tongue felt like burnt and her food tasted funny, and face still felt funny, her neck hurt. On 29May2021 her jaw locked up, when brushing teeth water dribbled out of side of her mouth, she could not open her mouth wide enough to eat. On next day 30May2021 her son noticed that patient's face drooping on one side called 911. She thought she was having a stroke but at the hospital said she had Bell's Palsy. The doctor at the hospital stated it was one of the side effects of the shot. The patient started to take 60mg of Cymbalta and .37mg of Synthroid daily as a treatment to event. The outcome of the events was unknown.
53 2021-06-10 pain in extremity headache; tiredness/ bouts of extreme fatigue; Sore arm; This is a spontaneous report from contactab... Read more
headache; tiredness/ bouts of extreme fatigue; Sore arm; This is a spontaneous report from contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Mar2021 08:30 (Batch/Lot number was not reported) at the age of 53 years old as second dose, single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication wasreported as none. Prior vaccinations within four weeks was reported as none. The patient previously received first dose of BNT162B2, anatomical site of injection: left arm on 09Feb2021 at 8:45 AM for COVID-19 immunization. The patient experienced tiredness on 04Mar2021 at 12:00, headache on 04Mar2021 at 17:00 and sore arm on 04Mar2021 (also reported as "07Apr2021", pending clarification) at 9:00. Patient also stated that "I received the second dose of vaccine on 3Apr. Since then I have had bouts of extreme fatigue. Is this a long term side effect?" (pending clarification) The events did not required treatment (initiation of new medication/other treatment/ procedure). The outcome of the event "tiredness/bouts of extreme fatigue" was recovered on 25Mar2021, for headache was recovered on 05Mar2021 and for "Sore arm" was recovered on 06Mar2021. No follow up attempts are possible. No further information expected.
53 2021-06-11 nerve pain severe shingles on the right upper face. Right eye and right face was swollen. Visited ER room, alm... Read more
severe shingles on the right upper face. Right eye and right face was swollen. Visited ER room, almost hospitalized. Crack was detected on the cornea. 1) Anti-inflammatory, antiviral and antibiotic medicine were given to the first 10 days at the maximum doses each day. 2) Blisters were crusted after 2 weeks 3) severe nerve pain after the rash was gone. 4) Lyrica was prescribed but didn't show much effect in reducing the pain.
53 2021-06-13 pain in extremity, numbness Severe shoulder pain; right side. Pain started in back below the collar bone and radiated down arm. ... Read more
Severe shoulder pain; right side. Pain started in back below the collar bone and radiated down arm. Numbness in first three fingers. PAIN WAS A 8-9. ER visit on 5/31 and again on 6/1.
53 2021-06-13 pain in extremity Episcleritis in left eye in May. Hard nodules formed on multiple finger joints on both hands after s... Read more
Episcleritis in left eye in May. Hard nodules formed on multiple finger joints on both hands after sleeping over the course of a week (June 4-11); aching in hands, wrists, shoulders, hips, knees and feet. Lump forming on left wrist (June 13). Joints popping when moving. Unable to move without pain.
53 2021-06-14 weakness Extreme tiredness, lack of energy since second vaccine. Need to sleep 18+ hours per day since vaccin... Read more
Extreme tiredness, lack of energy since second vaccine. Need to sleep 18+ hours per day since vaccine - no tiredness before vaccine. Trouble concentrating and inability to complete home and work duties due to extreme tiredness and lack of energy to move.
53 2021-06-14 breast pain She started to get constant, left-sided chest pain focally near her sternum 1 day after receiving th... Read more
She started to get constant, left-sided chest pain focally near her sternum 1 day after receiving the vaccine. She had a 3 to 4/10 rating for her pain with exacerbations that would wake her up at night. Her pain did get so bad that she pursued evaluation for her chest pain at the emergency department on 05/21/2021. Could not find any cardiac etiology for her chest pain but asked her to follow-up with primary care. She saw me in clinic today, 6/15/2021, where I performed a history and physical assessment, including a breast exam. Findings were that she had bilateral mastodynia but had focal pain worse in the left chest where she has had pain all along.
53 2021-06-14 flushing My adverse event started with the dosage 1 of the Pfizer Vaccine. On April 1st, I had eaten dinner a... Read more
My adverse event started with the dosage 1 of the Pfizer Vaccine. On April 1st, I had eaten dinner and didn't feel right (within an hour and 15 minutes I felt a weird sensation in my throat and my blood pressure stated to climb up to 192/122 and I was rush to the ER by ambulance and they gave me a baby aspirin. The Doctor performed a CT Scan and found that the protein in my blood was elevated via blood test performed and upon being released from the hospital, I went to see my PCP because my blood pressure was spiking daily (been on blood pressure medication and my blood had never spiked before). I had 4 or 5 total episodes where my blood pressure would spike too high and I could feel pulsation in my neck and the hospital could not pinpoint. I took my medication and it would go away but would return 10 hours later (face would also become flesh). My Doctor put me on a beta-blocker 30 gram per day and am on Lytensopril was doubled on 20 grams instead of 10 grams. I am also on Propranolol 10 mg tablets 3 times per day (beta-blocker), and Spironolactone 25 mg twice per day. It's very disturbing because I'm on 7 medications and a heart monitor (on my 9th day...mail in on June 21st to get the results). I will be having a stress test done at the end of June and a possible Angio-gram which I am holding off on.
53 2021-06-14 pain in extremity Fatigue and arm soreness 16 hours later. . The about 20 hours later fever of 102, myalgia, arthralgi... Read more
Fatigue and arm soreness 16 hours later. . The about 20 hours later fever of 102, myalgia, arthralgia, dizziness, sore throat . S/ lasted about 24 hours Ecco the arthralgia persisted x 5-7,days.
53 2021-06-15 facial paralysis, face paralysis Muscle weakness to right side of face. Could not close right eye, lift right eyebrow. Smile drooped.... Read more
Muscle weakness to right side of face. Could not close right eye, lift right eyebrow. Smile drooped. Was prescribed Prednisone, Valacyclovir for 7 days and carboxymethylcellulose drops when needed
53 2021-06-15 pain in extremity I developed pain up and down my right arm quite suddenly, basically from the shoulder all the way in... Read more
I developed pain up and down my right arm quite suddenly, basically from the shoulder all the way in to my wrist and fingers off and on, it got progressively worse it was very painful, I went to the doctor and they ordered an ultrasound to ruled out a blood clot. They had to do the ultrasound on the ER and they found a clot in my basilic vein. They gave me a pain med so I could sleep and add heat and Ibuprofen. I am being referred to another doctor because the pain is coming back and they are going to do more tests. I have donated blood about a month before I had the vaccine and the ER doctor thought this may be because of that.
53 2021-06-15 pain in extremity pain in right thumb; pain in index finger joint; pain in wrist; pain and stiffness in my right thumb... Read more
pain in right thumb; pain in index finger joint; pain in wrist; pain and stiffness in my right thumb; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 11Feb2021 (Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. Medical history included hypertension, goitre , anxiety and "Known allergies: Blackened Seasoning". Patient did not have Covid prior to vaccinationand was not tested post vaccination. Concomitant medication(s) included hydrochlorothiazide/triamterene (TRIAMTERENE & HCTZ) taken for an unspecified indication, start and stop date were not reported; diltiazem hydrochloride (DALTAZEN) taken for an unspecified indication, start and stop date were not reported; buspirone taken for an unspecified indication, start and stop date were not reported. On 16Feb2021 07:00, patient experienced pain in right thumb, pain in index finger joint, pain in wrist, pain and stiffness in my right thumb. Therapeutic measures were taken as a result of the event included: Quick fit Wrist/Forearm UNIV, RTbrace and Ibuprofen. Outcome of events was not recovered. No follow up attempts are Possible. No further information is expected.
53 2021-06-16 feeling hot, flushing At 1635 client approached EMTs to let them know she was feeling chills and warmth. EMT gave client w... Read more
At 1635 client approached EMTs to let them know she was feeling chills and warmth. EMT gave client water and snack. PHN joined at 1640. Upon arrival client sitting upright in chair, alert and oriented x4. Client reported history of hypertension, current medications estrogen and "one pill for hypertension" and severe allergy to penicillin. PHN observed client's face flushing. Client reported feeling itchy on face. Client denied shortness of breath, throat closing. PHN offered client Bendaryl, client advised on Benadryl causing drowsiness. Client declined due to not having anyone to pick her up. PHN offered client paramedics and client declined. Vitals at 1647 by EMT: blood pressure 132/88, pulse 79, oxygen sat 100%. Client reported itchiness spreading to chest and left arm. Vitals at 1654: blood pressure 136/90, pulse 80, oxygen sat 100%. PHN offered client Benadryl again and client accepted. PHN administered 50mg Benadryl orally at 1657. Vitals at 1701: blood pressure 136/88, pulse 78, oxygen sat 100%. Client reported chills has resolved. Itchiness of face and left arm the same. Vitals at 1707: blood pressure 140/90, pulse 78, oxygen sat 100%. Per client itchiness still present but improving. Vitals at 1713: blood pressure 142/90, pulse 83, oxygen sat 100%. Per client some itchiness still in face and at site of vaccination in left arm. Flushing of face improving. Vitals at 1717: blood pressure 140/90, pulse 79, oxygen sat 100%. Client reported feeling "better". PHN advised client to follow up with provider and gave ER precautions. Last vitals at 1723: blood pressure 138/86, pulse 73, oxygen sat 100%. Per client feeling "fine to drive" and that she lives less than 10 mins away. PHN discussed with client if someone could pick her up, taxi, or Uber due to drowsiness. Client left facility against medical advise regarding driving at 1724 with steady gait.
53 2021-06-16 muscle spasms Chronic and severe all over body ache; Muscle aches; Swollen and painful joints; Swollen and painful... Read more
Chronic and severe all over body ache; Muscle aches; Swollen and painful joints; Swollen and painful joints; Headache; Fatigue; Back spasms; swollen/painful lymph nodes under both armpits; swollen/painful lymph nodes under both armpits; This is a spontaneous report from a contactable consumer (patient). A 53-Year old Female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0150, on 16Mar2011 11:00 at single dose in right arm (at the age of 53-year-old) for COVID-19 immunization. Medical history included Depression, Attention deficit hyperactivity disorder (ADHD), Hashimoto's disease, Fibromyalgia, Rheumatoid disease, and known allergies Latex. Concomitant medication included unspecified medication. The patient did not receive other vaccine in four weeks. The patient received Other medications in two weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. On 17Mar2021 12:00, the patient experienced Chronic and severe all over body ache, muscle aches, swollen and painful joints, headache, fatigue, back spasms and swollen/painful lymph nodes under both armpits. She had appointment with PCP for referral to rheumatologist 09May2021. All events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for events. Lab data included HLA-B27 gene positive. The outcome of all events was not resolved. Follow-up actions are needed. Further information has been requested.
53 2021-06-16 pain in extremity rash; hives/Hives on her upper legs, buttocks, and stomach; Her ears were purple and inflamed; itchy... Read more
rash; hives/Hives on her upper legs, buttocks, and stomach; Her ears were purple and inflamed; itchy; sore arm; headache; This is a spontaneous report received from a Contactable consumer. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730 and Expiration date was not reported), via an unspecified route of administration, in Arm left, on 30Dec2020, Wednesday (at the age of 53 years), as a single dose for COVID-19 immunization. The patient medical history included Blood pressure and Cholesterol. Concomitant medications included Losartan with Hydrochlorothiazide for Blood pressure, Crestor for cholesterol. There was no patient history and no Investigation Assessment. On an unknown date, the patient stated that she had a delayed reaction. Three to four days later, she developed a rash and hives. That night, on the vaccination day she developed headache and a sore arm on 30Dec2020. She doesn't know if it was related or not, but on 02Jan2021, she became itchy. On 03Jan2021, she had hives on her upper legs, buttocks, and stomach. On 03Jan2021, her ears were purple and inflamed. She was supposed to get the second shot, but she was not sure if she should or shouldn't get it. She was scheduled three weeks after her first, but didn't go because she was afraid. She works at a nursing home, and now some of the residents are getting their first shot so she has the option to get her second today. Her headache started during her sleep. She just took Advil for the headache. She still has little headaches on and off so she is unsure if they are related. It took about 3 days for the arm soreness to go away. She went to urgent care, and they gave her prednisone for 5 days. It was Friday the 8Jan2021 when she stopped itching and having hives. She didn't really want to get the vaccine in the first place but did because she works in healthcare. Outcome of the event rash was reported as unknown and headache, itchy, hives, sore arm, ear infection was reported as recovered. Follow-up attempts completed. No further information expected.
53 2021-06-16 pain in extremity right arm was very sore; feeling horrible; Body aches; headache; joint pain; nausea; tired; chills; ... Read more
right arm was very sore; feeling horrible; Body aches; headache; joint pain; nausea; tired; chills; fever (100.4); muscles ached; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6199), via an unspecified route of administration in the right arm on 13Mar2021 at 10:00 AM (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications include cholesterol off (not codable) (MANUFACTURER UNKNOWN), vitamin c (MANUFACTURER UNKNOWN), vitamin d3 (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN). The patient experienced sore right arm, slept on her left side on 13Mar2021 at 16.00, woke up feeling horrible, body aches, headache, joint pain, nausea, tired, chills, fever (100.4), muscles ache. Patient had taken 2 Tylenol (MANUFACTURER UNKNOWN) as treatment for reported events. The clinical outcome of the events body aches, chills, feeling horrible, fever (100.4), headache, joint pain, muscles ached, nausea, right arm was very sore, tired were resolved. No follow-up attempts are needed. No further information is expected.
53 2021-06-16 tingling The patient is a 53 yo healthy female who reports continued shoulder pain (left) after receipt of Pf... Read more
The patient is a 53 yo healthy female who reports continued shoulder pain (left) after receipt of Pfizer BioNTech COVID vaccine #2 (ER8736) 30 APR 2021. She reports no immediate symptoms after receipt of vaccine to suggest IgE event and no immediate pain. She believes site placement was correct. She was sitting and the vaccinator was standing. She had no local site reaction. Pain onset was within 2-3 days. She states it has continued to worsen, is throbbing in character, and impacts function. She has difficulty lifting her arm, reaching above her had or rotation to reach behind her such as her back pocket. Pain can be as high as 9/10. She has tingling to her fingers, but denies neurologic weakness, just inhibited by pain. She has not done any treatment. She saw PCP yesterday who prescribed ibuprofen, but she has not started it. No history injury to affected shoulder No history adverse reaction to any prior vaccines.
53 2021-06-17 pain in extremity pain in the left arm; Loss of grip strength; pain in the left arm, her whole left side/ right side h... Read more
pain in the left arm; Loss of grip strength; pain in the left arm, her whole left side/ right side had pain; This is a spontaneous report from a contactable consumer(patient). This 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 05Apr2021 (lot number EW0150), 2nd dose on 26Apr2021 (lot number EW0164), both at 53-year-old via an unknown route for Covid-19 immunization. Patient stated she had no medical conditions, was a healthy individual. Concomitant drug was not provided. Patient experienced pain in the left arm, her whole left side, and pain was continuing. It was severe. She went to the emergency room on 23May2021. When she got the second vaccine she was still having pain and it had not gone away. She went to the hospital they gave her a muscle relaxer and an injection. She had taken Diclofenac Sodium and then changed to take Diclofenac Potassium. The right side had pain but the left was much worse. She had also lost her grip strength. She could not carry anything, could not open a bottle. She has a doctor appointment upcoming this month (as of 03Jun2021) related to these symptoms. Patient also stated that pain was getting worse. Her pain was extreme. She was worried and hopes she does not die. Outcome of the events was unknown.
53 2021-06-18 weakness Fever, nausea, pain at injection site, weakness, all-over muscle aches, Headache, fever, chills, unb... Read more
Fever, nausea, pain at injection site, weakness, all-over muscle aches, Headache, fever, chills, unbearable pain in abdomin, diarrhea, anxiety, exhaustion.
53 2021-06-18 feeling hot Hot, swollen, painful lymph nodes, temp 100.1F, pain of ovaries
53 2021-06-18 pain in extremity COVID arm. Intense swelling and pain on most of upper arm
53 2021-06-20 cold extremities After recieving the Covid 19 Pfizer EW0181 vaccinne at pharmacy I expeirienced icing on the injectio... Read more
After recieving the Covid 19 Pfizer EW0181 vaccinne at pharmacy I expeirienced icing on the injection site a hour later. During the same day i experieced icing on my legs. the next day i saw rashes spreading all over my legs as well as bruises. its been spreading to my chest next and arms. I went to the doctor and he prescribed Triamcinolone Acteonide and Hydroxyzine HCL25MG. I have tried benedryl, cortizon, and providone-lodine, and calimine lotion with no possive effect. The doctor instructed me to file this form with you and instructed me not to take the second dose
53 2021-06-21 hot flush, tingling Initial tingling in right arm. Injection was provided in right lateral deltoid. Approximately 40 m... Read more
Initial tingling in right arm. Injection was provided in right lateral deltoid. Approximately 40 minutes after vaccine was provided, employee had nausea and localized rash. Employee escorted to ED for further assessment. Employee then experience hot flash and right side headache.
53 2021-06-21 numbness, tingling numbness and tingling on left side of head, face, left arm and left leg and dizzy.
53 2021-06-21 migraine, weakness, cold sweat, hypersensitivity of all senses eye pain beginning two days after shot on both 5/19 and 6/9 dull headache low energy that did not go... Read more
eye pain beginning two days after shot on both 5/19 and 6/9 dull headache low energy that did not go away- cold sweats with mild fever for 24 hours the 48 hours after. Migraines began on day 6 of each shot. Pain specific to left eye and migraine cluster on left side. Head sensitive to touch. Vision problems began on day 10 both times. intermittent- white outs where vision was lost in left eye for 30 seconds to two minutes. Day 11 eye symptoms and headache the same- complete vision loss in left eye with white out that lasted for 4 hours each time. Migraine intensified to pain level of 10 unable to sleep or do daily activity. Blurred or smokey vision began on day 12 and lasted until day 19 currently still experiencing same symptoms on day 14 of second shot
53 2021-06-21 tingling, numbness Severe shoulder pain extending into neck. With severe stiffness pain baseline & with movement increa... Read more
Severe shoulder pain extending into neck. With severe stiffness pain baseline & with movement increasing over days. With mod headache. No redness. No temp change. Headache improved with NSAID. Pain & stiffness unhelped. . started within 6 hours of initial shot, left arm. Within 2 hours of second shot, right arm, with tingling & numbness accompanying - only numb/tingling continuing mild to date.
53 2021-06-22 numbness, discomfort, tingling I received the vaccine on my left arm and within about 10 to 15 minutes I starting feeling a numbin... Read more
I received the vaccine on my left arm and within about 10 to 15 minutes I starting feeling a numbing, tiggling sensation on the left side of my face...I also felt it on the whole left side of my head and neck. I went and mentioned it to the Pharmacist, she replied to sit for another 10minutes. It seems to be ok. I drove home and it seems to subside. it started up again and woke up the next day with my left side feeling heavy. I called my Dr's office and they recommended I come in to get checked. I did not feel it so much on Friday. However, at times I still something going on me left side of my face/head.
53 2021-06-22 numbness, numbness and pain in extremities About 40 minutes after the vaccine, when I was driving home, my feet and lower legs went numb. I was... Read more
About 40 minutes after the vaccine, when I was driving home, my feet and lower legs went numb. I was unable to feel pressing the brake pedal, and had to stop and call someone to drive me home. The condition improved in the first 2 weeks, but the numbness has not gone away at this point. I also have a slight numbness in my finger tips. Neurology determined I have neuropathy in my legs. I currently have numbness mid calf and below on both legs, and in my feet, and finger tips, although the left seems worse.
53 2021-06-22 migraine Migraine HA. Medications could not break it. it lasted 5days. Had to go to my neurologist for a shot... Read more
Migraine HA. Medications could not break it. it lasted 5days. Had to go to my neurologist for a shot to try and relieve the pain
53 2021-06-23 pain in extremity severe pain in vaccinated arm requiring evaluation by health care professional, arm is swollen, no l... Read more
severe pain in vaccinated arm requiring evaluation by health care professional, arm is swollen, no lymphadenopathy, no sign of infection, Rx provided for meloxicam
53 2021-06-23 pain in extremity March2021: Slight bleeding on top left side of teeth 6 days after my 2nd vaccine for about a week. ... Read more
March2021: Slight bleeding on top left side of teeth 6 days after my 2nd vaccine for about a week. The bleeding started again 2 weeks later. I also missed a months period after my vaccine (60+ days since last period). There was pain in my right ovary area and that leg hurt a week after my 2nd vaccine. It stopped after taking Tylenol . The bleeding on my upper gums continues-more bleeding occurs in the morning, but also happens when cleaning or touching. Very pronounced bleeding from minor touch of toothbrush or floss. I visited dentist and asked me to set a new routine which included a prescription mouth rinse to rule out gingivitis or periodontal disease. He also ordered a deep cleaning in the near future. It is now June and the bleeding still exists (3 months after vaccine).
53 2021-06-23 tenderness, pain in extremity, migraine About 12hrs after my arm began to hurt really bad. It hurt so bad for about 5 days it was so sensit... Read more
About 12hrs after my arm began to hurt really bad. It hurt so bad for about 5 days it was so sensitve you couldnt touch it. About 48 hours later I developed really bad migranes that came off and on and lasted a couple days. I have sensitivity to light and just wanted to stay in bed because I was extremely tired and fatigued. My arm still hurts and has sensitivity to date just not as bad as it was in the beginning
53 2021-06-24 flushing, pain in extremity This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm 19Mar2021 at 10:30 (at the age of 53-years-old) as a single dose for COVID-19 immunization. The medical history included fibromyalgia, chronic fatigue, allergies, migraines, cervical stenosis, restless legs and pain. The patient had a history of allergy to penicillin, sulfa, Keflex, adhesives, iodine contrast, cats, ropinirole and others. Concomitant medication included plaquenil (MANUFACTURER UNKNOWN), tolterodine (MANUFACTURER UNKNOWN), ASPIRIN, clonazepam (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient had not been tested positive for COVID-19 since vaccination. On 19Mar2021 at 11.15, the patient experienced some itching on right arm, but thought it was a scrape irritated by sun, the arm that was not the injection arm was still pretty red and face was fairly flushed and there was a single hive. When patient took shower, she started to feel itchy burning on scalp, ears, and nose, which was not terrible. While in the shower, her arm started to ache and felt dizzy. When she went out, the itching continues at almost 17:00. The patient was not having a bad time breathing. The patient had taken allergy medicine before the shot. The events didn't resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the reported events were unknown. The clinical outcome of the events itching, hives, pain in arm, flushing and dizzy were not recovered. Information about lot number cannot be obtained. No further information is expected.
53 2021-06-24 pain in extremity, muscle twitching Involuntary twitching; pain in arm; High blood pressure; headache; This is a spontaneous report from... Read more
Involuntary twitching; pain in arm; High blood pressure; headache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: unknown), via unspecified route of administration in the left arm on 18Mar2021 at 07:00 PM (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not included. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient was not tested positive for COVID-19 since the vaccination. On 18Mar2021 at 07:00 PM, the patient experienced twitching, pain in arm, blood pressure high and headache. The patient reported that involuntary twitching in her left arm since she received the vaccine 24 hours ago resulting in difficulty going to sleep, relaxing. Pain in arm resulting in difficulty raising her arm to lift, clean, dress. High blood pressure and headache lasted 24 hours. The Clinical outcomes of twitching, pain in arm and blood pressure high were not resolved; while that of headache was resolved. No follow-up attempts are possible; information about lot number cannot be obtained.
53 2021-06-24 pain in extremity Arm became sore; it feels like a little pain,I felt like little pain under my armpit; Under my arm p... Read more
Arm became sore; it feels like a little pain,I felt like little pain under my armpit; Under my arm pretty swollen where I had took this shot,its swollen and it's very irritating and little painful; This is a spontaneous report received from a contactable consumer (patient) or other non-health care professional. A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8729, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 53-years-old) as 1st dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. it was unknown that patient was pregnant. On 09Jun2021 patient experienced Arm became sore, it feels like a little pain, I felt like little pain under my armpit, under my arm pretty swollen where I had took this shot, its swollen and it's very irritating and little painful. Consumer stated, her son had a Doctor Appointment where she did a check-up, they did a check-up, so, we went to the clinic and now as they took his check-up, they asked him if he took the shot and want to take Pfizer shot, you know and he was like No, so, he could go ahead and take the Pfizer shot and I said what he taking it, I am taking also, I am also 53 years old so that is my first shot and his first time taken this shot also he could get back to his school so the nurse told us when we got home to take Tylenol so we both took a Tylenol. On 09Jun2021, later that night arm became sore so we both put alcohol on our arm, that was Wednesday so Yesterday I put alcohol on my arm it feels like a little pain, I felt like little pain under my armpit do you know later that night under my arm started hurt a little bit, I didn't know what it was, so the day she got up this morning and took a shower under my arm pretty swollen where she had took this shot under my arm today swollen you know that was, it was little painful. Consumer stated, mean basically right you know like I would never thought that, you know everybody got it shot and everybody got different side effects but it so happen I happened this side effect on my arm and its swollen and it was very irritating and little painful. Reporter state, it got expiration date 31Jul and on the back of the card they got the date that I go back, 30Jun. Other Medical Conditions: Consumer stated, she don't take no medications, she had took any prescription, she had been feeling Swollenness in her left arm since she took the shot and it was swollen and it was very irritating and little painful you know it was on my second, not her second, On her left side of the shoulder where she took the shot and rub an alcohol and took a Tylenol and she got painful later that night she pore some more alcohol on it, this arm was hurting and Irub alcohol on here, later that night when she was laying on the bed, she felt like little pain under her armpit on next morning she saw that it was real swollen under her armpit on the left hand side she took a shot at. Treatment was received for the event Arm became sore. The outcome of the events was reported as unknown. Follow-up attempts are needed. further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021695141 Same reporter/ drug, different AE/ patient
53 2021-06-24 pain in extremity arm became sore; it feels like a little pain; under my arm pretty swollen where I had took this shot... Read more
arm became sore; it feels like a little pain; under my arm pretty swollen where I had took this shot; its swollen and it's very irritating and little painful; I felt like little pain under my armpit; I saw that it was real swollen under my armpit on the left hand side I took a shot at; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received BNT162B2(CONMITARY, Solution of injection, Lot Number: ER8729; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 53-years-old), as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm became sore, it feels like a little pain, under my arm pretty swollen where she had took this shot, its swollen and it's very irritating and little painful, she felt like little pain under my armpit, the patient saw that it was real swollen under my armpit on the left hand side she took a shot at on an unspecified date. Therapeutic measures were taken as a result of arm became sore, it feels like a little pain, under my arm pretty swollen where she had took this shot, its swollen and it's very irritating and little painful, she felt like little pain under my armpit, she saw that it was real swollen under my armpit on the left hand side she took a shot at. The outcome of the events was unknown. Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021695222 Same reporter/ drug, different AE/ patient
53 2021-06-24 tingling, weakness, numbness Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Gener... Read more
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness /Lightheadedness-Mild, Systemic: Exhaustion/Lethargy-Medium, Systemic: Fever-Mild, Systemic: burning sensation in skin-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extremities)-Medium, Systemic: Weakness-Mild, Additional Details: numbness and tingling in arm, back and spine. Patient states symptoms felt like shingles. Loss of feeling from mid-spine up. Burning sensation on upper, left shoulder.
53 2021-06-25 tingling, cold extremities, numbness, pain in extremity before vaccination she has not have her menstrual cycle for quite a while, and it then started yeste... Read more
before vaccination she has not have her menstrual cycle for quite a while, and it then started yesterday.; her periods were "heavy, flooding" with "cramps"; her periods were "heavy, flooding" with "cramps"; gums that have been bleeding easier than normal; a weird pain in her upper legs, at the "top part", which started in her left leg and radiated to the right one, last night.; Interstitial Cystitis anyway, flare it up; excessive, frequent and urgent urination; excessive, frequent and urgent urination; excessive, frequent and urgent urination; the arm where she was vaccinated was "cold to touch and sore; the arm where she was vaccinated was "cold to touch and sore; her "little finger and ring finger in both hands" were "numb and tingling", which then spread to her arms.; her "little finger and ring finger in both hands" were "numb and tingling", which then spread to her arms.; intermittent headaches; waves of nausea; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received the first dose for BNT162B2 at single dose at Arm Left on 28May2021 at 17:58 for COVID-19 immuniation (53-year-old at vaccination). Relevant history included positive ANA, Interstitial Cystitis and Ocular Rosacea. Relevant concomitant drug included Doxycycline at 50 mg twice daily for ocular rosacea since 1 week before getting the vaccine to 27May2021. She noticed an increase in urination after starting it. Was told it was okay to get the vaccine while on it. Stopped it due to irritation in her stomach. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No family medical history relevant to AE(s). The patient explained she has experienced various side effects from the first dose. She reported having "excessive, frequent and urgent urination", which lasted for three hours the night she was vaccinated. She mentioned the arm where she was vaccinated was "cold to touch and sore." Her "little finger and ring finger in both hands" were "numb and tingling", which then spread to her arms. She then listed the following as additional symptoms: "intermittent headaches, waves of nausea, and gums that have been bleeding easier than normal". She then explained before vaccination she has not have her menstrual cycle for quite a while, and it then started since 09Jun2021 (reported as yesterday). She specified this morning, her periods were "heavy, flooding" with "cramps", which she had never experienced "at that level" before/ "more than typical". Lastly, she reported a weird pain in her upper legs since 07Jun2021, at the "top part", which started in her left leg and radiated to the right one, last night. She described this weird pain as "deep in" her legs, "not a muscular pain" but one that is either related to her "blood vessels or nerves". She said this pain is "not constant but shooting". She asked if these symptoms are normal after getting the vaccine. The patient further specified that evening she had excessive, frequent and urgent urination; she was drinking more that day, but not that much more. That same night, her left arm was cold to the touch and sore. She also woke up during the night with numb and tingling fingers on both hands; it was her little finger and ring fingers on both hands; it would start in her hand and go up her arm. She had intermittent headaches and waves of slight nausea. States that she has not had a full menstrual cycle for some time, but yesterday she started her cycle and last night it got heavier, and today it's really heavy, like it's flooding. She also has really bad cramps. Her gums have been bleeding easier as well for the past couple days, but she did not see any blood today when she brushed her teeth. Also, she has leg pain; it started in her upper left leg on the 7th, deep in a vain, almost like a nerve pain, but last night it was in her right leg; it comes in waves. The pain is in the top inside part of her legs. It's either a nerve thing or a blood vessels thing. When she was experiencing the frequent urination, she started wondering if the vaccine was all leaving her body, so now she doesn't know if she has the protection from the vaccine. Is there a way to check that? She has Interstitial Cystitis anyway, and there are a lot of things that can flare it up, but this just lasted longer. States that it lasted about 3 hours, and now she is back to her normal. While it was occurring, it was excessive, she went to the bathroom about 8-10 times an hour and her pee was clear. States she was trying to drink more water to make sure she didn't get dehydrated, but as soon as she drank, she would have to go again. She stated the intermittent headache and slight nausea, she expected to have after the vaccine. The cramping from her cycle is easing up, but the flow was really heavy earlier today, but in the last hour is has slowed a bit. On the night of 08Jun2021, her gums were really bleeding when she was brushing her teeth, and last night they were bleeding, but this morning there was no bleeding at all, so hopefully it's stopped but she won't really know until she brushes her teeth tonight. The events did not result in Emergency Room or Physician Office visit. No relevant tests performed. The outcome of event pain in leg, gums have been bleeding was resolving. The outcome of other events was resolved. The patient was due to get her 2nd dose on 10Jun2021, but she was nervous to get it. She has auto-immune concerns; she has a positive ANA. Her doctor told her that she definitely needs to get the vaccine. She had her second dose scheduled on 18Jun2021. Information on Lot/Batch number was available. Additional information has been requested
53 2021-06-27 weakness Fever 100.5-102, severe headaches, severe injection site pain, severe/complete nasal congestion/bloc... Read more
Fever 100.5-102, severe headaches, severe injection site pain, severe/complete nasal congestion/blockage-mouth breathing, severe unrelenting cough, burning in nasal passage, throat/chest, severe pain & soar throat, throbbing in all sinuses, generalized weakness and general feeling of unwell, loss of taste, loss of smell, loss or heard of hearing, persistent nasal dripping, sneezing,-> light yellow sputum/nasal discharge beginning in week two. Last fever was on 6/21, current persistent symptoms are loss of smell, taste, and partil hearing. Tylenol 500 mg / ibuprofen every 6 hours x 8 days, Alka seltzer cough /cold x 4 days every 6 hours, Sudafed every 6 hours x 4 days, Benadryl 25 mgs every 4- 8hrs x 5 days, Amoxicillin 500 mg twice daily x 15 days
53 2021-06-27 pain in extremity Patient had fever exceeding 104 F for following three days along with severe shoulder/arm pain. Feve... Read more
Patient had fever exceeding 104 F for following three days along with severe shoulder/arm pain. Fever dissipated after three to four days. However, severe shoulder/arm pain and stiffness persisted for weeks. After seeing family physician for continued shoulder/arm pain and stiffness, patient was referred to Orthopedic for evaluation on May 28, 2021. An X-Ray was performed at the 5/28/2021 Orthopedic visit. Doctor ordered an MRI on June 13, 2021. At follow up appointment on June 22, 2021 Doctor stated that he recommended surgery to address "frozen shoulder" indicating pain in left shoulder/arm due to COVID vaccine. Surgery is scheduled for July 15, 2021.
53 2021-06-27 tingling, weakness Went to bed with racing heart and chills on the 23rd of March. Felt weak on the 24th and couldn't g... Read more
Went to bed with racing heart and chills on the 23rd of March. Felt weak on the 24th and couldn't go to work. On the 27th, took my Lyme antibiotic, Tinidazole. Felt weak on the 28th. Better on the 29th and took second antibiotic - Azithromycin - in the AM. Early that evening, began feeling burning skin, pins & needles in arms and upper body, severe chills with no fever, frequent urination and bowel movements, chest wall pain and high anxiety. Tried to go to bed, was unable to sleep because chills lasted throughout the night. Went to hospital at 7AM on the 30th. Was released same day. They didn't prescribe anything. Spent the next two weeks on bed rest due to severe weakness and fatigue. Went back to work on Tuesday, 4/13/21, for four days. On Saturday and Sunday was bedridden again. Went into work on 4/19/21 and was sent home due to racing heart and weakness. On Saturday, 4/24/21, went back into hospital with racing heart, chills, weakness, nausea, chest wall pain, high anxiety. Release same day. Didn't go to work from 4/26-4/30. Took leave of absence from work (I am an elementary school teacher) from May 3-June 23, 2021.
53 2021-06-29 numbness, flushing 25 minutes after shot. bright red hotflushed face; Tingly tongue; Itchy throat; Numb/tingly nose; 2 ... Read more
25 minutes after shot. bright red hotflushed face; Tingly tongue; Itchy throat; Numb/tingly nose; 2 episodes of heart palpitations; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old non pregnant old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 21Mar2021 at 16:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient medical history included menopause and thyroid issues. The patient was allergic to penicillin and amoxicillin. The patient received unspecified other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 16:30 reportedly 25 minutes after shot the patient experienced bright red hot flushed face, tingly tongue, itchy throat, numb/tingly nose and two episodes of heart palpitations. The symptoms subsided within an hour or so. The patient was allergic to penicillin/amoxicillin and not sure if that was related. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events. The clinical outcome of bright flushed face, palpitations, Itchy throat, Numb/tingly nose, tingly tongue was recovered on 21Mar2021. No follow-up attempts are needed. No further information is expected.
53 2021-06-29 numbness, migraine Starting immediately after first dose and continuing on till today continuous migraine headaches, M... Read more
Starting immediately after first dose and continuing on till today continuous migraine headaches, May 5th a severe case of what was diagnosed as vertigo which included ER admission, core body temperature of 94, vomiting, disorientation. Loss of consciousness. None of these symptoms have ever presented prior to vaccine. June 24th admsision to ER with numbness in left hand, foot, face and mouth. All tests returned normal given Gabapentin and told to follow up with Neurologist who we were already seeing for headaches. Prior to neurology visit, victim presenting with increased numbness, disorientation and lack of balance.
53 2021-06-29 pain in extremity Sore arm; fatigue; This is a spontaneous report from a contactable other healthcare professional, th... Read more
Sore arm; fatigue; This is a spontaneous report from a contactable other healthcare professional, the patient. A 53-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6207) via unspecified route of administration in the left arm on 21Mar2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included depression/anxiety, psoriasis. No known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Medications received in two weeks included vitamins (MANUFACTURER UNKNOWN), TRINTELLIX, trazadone (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) all for unknown indications and from unknown dates. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 20:45, patient experienced sore arm, fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events sore arm, fatigue. The clinical outcome of the events sore arm, fatigue were not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-06-29 pain in extremity I did have a sore arm for several days after the 2nd dose; This is a spontaneous report from a conta... Read more
I did have a sore arm for several days after the 2nd dose; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8730), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (at the age of 53-year-old) as dose 2, single for COVID-19 immunization. The patient received first dose of BNT162B2 (Lot number: EN6199, Expiration date: unknown) via an unspecified route of administration, administered in Left arm on 03Mar2021 at 13:30 (at the age of 53-year-old) as unknown dose for COVID-19 immunization. Historical vaccine included Cortisone shot on 01Mar2021 for arthritis: she got a cortisone shot in her hip two days before the first dose. The patient medical history was not reported. Family Medical History reported as None. Concomitant medication(s) include olopatadine hydrochloride (OLOPATADINE HYDROCHLORIDE OD) taken for seasonal allergies as one spray into each nostril, two sprays a night for taking it for 3-4 years; fexofenadine hydrochloride (ALLEGRA); fish oil (FISH OIL) ongoing; glucosamine sulfate (GLUCOSAMINE [GLUCOSAMINE SULFATE]) ongoing; curcuma longa root (TURMERIC CURCUMIN) ongoing; ginkgo biloba (GINKGO BILOBA PLUS [GINKGO BILOBA]) ongoing; collagen (COLLAGEN) ongoing; diphenhydramine hydrochloride (BENADRYL) ongoing; biotin (BIOTIN) ongoing. The other vaccine in four weeks was reported as none. The patient previously took minocin and codine for known allergies. Prior Vaccinations (within 4 weeks) reported as None. The patient not had COVID-19 prior vaccination; not tested COVID-19 post vaccination. Consumer stated that she got a cortisone shot 2 days before the first COVID-19 and she had a sore arm for several days after the 2nd dose and she heard from her mother's doctor that she should not get a cortisone shot within 2 weeks before or after the COVID shot because it might prevent the formation of antibodies. Her doctor did not tell her that. With the first shot she had absolutely no reaction, not even a sore arm. Just for a couple days, nothing much but at least she knew she got a shot. Now she was worried and wanted to know regarding the first shot, did the cortisone shot make the first shot ineffective. She stated that she got a cortisone shot in her hip two days before the first dose. States her mother went to get a cortisone shot on her knuckles, and she had both doses of the Moderna vaccine, and her doctor told her that she might not want to get her cortisone shot because it could affect the efficacy of the vaccine and she may opt to wait on her cortisone shot. Consumer stated that her mother told her that and caused her to panic. Her mom came home and told her that she didn't get her shot, her fingers are killing her but she didn't think it was worth the risk. She was referring to her mom not receiving the cortisone shot since she had the Moderna COVID vaccine per the doctor's suggestion. Consumer stated that the morning after her second dose around 8 am on 25Mar2021 she woke up with a sore arm. She states with the first dose she did not experience nothing, states not even slight soreness where they gave her the shot if she pressed on it. She Clarified that she got her cortisone shot on 1Mar2021, two days before she got her first dose. States she was freaking out a little bit. She states first dose was given at 1:30 pm EST. Second dose was given between 1:15-1:30 pm. Consumer stated that she started taking allergy shot give or take 10 years ago, could be more. On 25Mar2021 at 08:00, the patient experienced i did have a sore arm for several days after the 2nd dose. The patient did not receive any treatment for the events. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-06-29 pain in extremity Sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-... Read more
Sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL3247) via an unspecified route of administration in the left arm on 18Mar2021 at 10:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, gastrointestinal stromal tumour (GIST) and allergy to penicillin. The patient had taken unspecified concomitant medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL3247) via an unspecified route of administration in the right arm on 25Feb2021 at 10:30 as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within four weeks prior to the vaccination. On 19Mar2021, at 05:00, the patient experienced sore arm. The patient did not receive any treatment for the event sore arm. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event sore arm was reported as recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
53 2021-06-30 pain in extremity Pt. states received 1st vaccine 03/18/2021 reports constant terrible pain through left arm/shoulder.... Read more
Pt. states received 1st vaccine 03/18/2021 reports constant terrible pain through left arm/shoulder. Still lingering, No physician visit reported. Received 2nd 04/09/2021 no reported symptoms.
53 2021-07-01 burning sensation, numbness Patient stated being ok after 15 min observation time. She came back a few minutes later to the clin... Read more
Patient stated being ok after 15 min observation time. She came back a few minutes later to the clinic stating she felt a burning, numbing and swelling sensation near on her right neck/throat area. Her vitals were taken at 10:25am and read BP-140/84, HR-75, RR-18, O2 sat-98% at room air. She was given water and observed. she was talking and had no difficulty in drinking water, she had no complaint of having difficulty drinking. she stated it was feeling a bit better than when she first felt it. vitals were taken again in 10:45 and read BP-128/82, HR-70, RR-20, and O2 sat-97% at room air. Provider came in to exam patient and informed patient to monitor symptoms and if they got worse to return to clinic or go to hospital. Patient stated feeling better after being observed by the provider and was released home. Pt was contacted by phone at 4:17pm she stated the sensation and numbness had gone away and felt better.
53 2021-07-01 feeling of body temperature change, weakness High fever; Chills; Body aches; Headache; Heart rate elevated/heart rate went up/heart rate was high... Read more
High fever; Chills; Body aches; Headache; Heart rate elevated/heart rate went up/heart rate was high; Blood pressure elevated/blood pressure went up to 197/89/ blood pressure was back up to 151 and 187; Tired and exhausted; Weakness/extremely weak; Rapid heart palpitations; Got cold and really hot and that would go back and forth; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727), dose 2 intramuscular, administered in Arm Right in the muscle on 14Apr2021 17:30 as 2nd dose, single for covid-19 immunisation administered in Clinic. Medical history included hypotension (She is somebody whose blood pressure is always low. Her problem is it drops too low at night-time. She does not take medication to bring it up). Concomitant medication(s) included pravastatin at 20 mg once daily for blood cholesterol increased; hydrochlorothiazide at 12.5 mg for hypertension; ibuprofen (ADVIL [IBUPROFEN]) at 2 Advil, 4x/day (four times a day) for pyrexia, pain in extremity. Patient previously took first dose of BNT162B2 (Batch/Lot Number: EN6206), dose 1, administered in Arm left in the muscle on 24Mar2021 for covid-19 immunisation. The patient reported, she took the second shot for Pfizer and the day she took it her blood pressure and heart rate went up on 14Apr2021 22:30. She was tired and exhausted on 14Apr2021 21:00. She went to ER and they did X-ray, EKG, Blood work and everything was normal. Her blood pressure went up to 197/89. She has been in bed since Wednesday. She had normal high fever, chills, body aches, and was extremely weak on 15Apr2021 06:00. She is taking 2 Advil every 4 hours. If she does not, the fever and body aches come back. Yesterday, she did not immediately take the Advil every 4 hours and she felt, body aches and chills. Now she has an alarm on her cell phone, so she does not miss it. When fever started, the chills started. She got cold and really hot and that would go back and forth. When she went to ER with high blood pressure, that is when she had a headache on 14Apr2021 22:30. She left house about 11:30 pm when her blood pressure had gone up to 197. They did an EKG, Blood work and, X-Ray and they checked her thyroid, and everything was normal. They had no idea why her heart rate was high, or her blood pressure was high. The paperwork from the ER said she came for rapid heart palpitations. She went in for high blood pressure. She did have a high heart rate as well. They gave her an IV medication and her blood pressure went to 137. They let her go and 10 hours later, her blood pressure was back up to 151 and 187. She is the one who prescribed medication to lower her blood pressure. She prescribed Hydrochlorothiazide 12.5 mg. The doctor said to use it only if her blood pressure goes up to 150. They have her entire chart, and her concern is that her blood pressure drops. They did not want her to have it drop. The doctor said to make sure only take it if over 150. Today it was 181, but she is concerned to take this medication and she has not taken it. She is alone in her house. Prior Vaccinations within 4 weeks were none. The outcome of events were not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-07-02 flushing, feeling hot, burning sensation Feeling hot, flushed, burning arms/legs/head, tachycardia (125), fluttering heart, couldn't catch br... Read more
Feeling hot, flushed, burning arms/legs/head, tachycardia (125), fluttering heart, couldn't catch breath, feeling faint, tasted medicine in mouth, breathless
53 2021-07-04 night sweats Started feeling sick, feverish, night sweats, cough, heavy phlegm. Got worse & worse. Went to urgent... Read more
Started feeling sick, feverish, night sweats, cough, heavy phlegm. Got worse & worse. Went to urgent care on 6/17. Immediately taken to ER and was admitted to hospital for 8 days. Discharged 6/25. Diagnosis was pneumonia. Almost died because my lungs were so full of infection. I was perfectly prior to vaccine. No illnesses, lung problems, etc. hadn?t even been to a dr for being ?sick? for a few years.
53 2021-07-04 pain in extremity Day of vaccine arm started hurting and difficult to lift. Next day, arm hurting but add in high feve... Read more
Day of vaccine arm started hurting and difficult to lift. Next day, arm hurting but add in high fever over 102
53 2021-07-04 pain in extremity Patient came in presenting with tight nodules on palms of both hands. She indicated to be in pain a... Read more
Patient came in presenting with tight nodules on palms of both hands. She indicated to be in pain and unable to straighten. Her tendons appear to be very tight, causing her ring fingers to be bent inward, and she can't open her palms fully.
53 2021-07-05 difficulty speaking, hot flush Fever; Allergy; Tiredness; brain fog; Flu symptoms; mood swings; confusion; Hot flash; congestion; s... Read more
Fever; Allergy; Tiredness; brain fog; Flu symptoms; mood swings; confusion; Hot flash; congestion; sound little bit crackly; sore throat; allergy sinus; bruising at the site of the injection; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0177) via an unspecified route of administration on 12Jun2021 (at the age of 53 years old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included the patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0168) via an unspecified route of administration on 22May2021 (at the age of 53 years old) as dose 1, single for COVID-19 immunisation and no reaction experienced. On 14Jun2021, the patient had Fever, allergy, and tiredness. About three or four days after the vaccination, on an unknown date in Jun2021, after the vaccine she developed bruising at the site of the injection which remained for a week, after she was fed that injection and the bruise that a long to show up, she would have expected the bruising next day or two day but it took 3 or 4 days for the bruise to show up to feel it was there she just took a picture of it, She want to say on day 4 was when she got this brain fog, very big brain fog and came down flu symptoms, where appeared or very big allergy sinus symptoms and the brain fog sort of made her feel how can she say this mood swings, she had mood swings with the brain fog, it was sort of confusion and with allergy sinus, She felt lots of tiredness and did have fever that would come and go, she was going to say it happen it would appear and then stay about 5 or 2 minutes, then they then may be one or two hours it appeared again almost like a hot flash kind of thing, fever thing had subsided and the allergy sinus had subsided, she want to say because she was in a desert planet that had help to dry it up but she feel like was still left with brain fog. She still had sort of feel like a little congestion or sore throat but sort of affecting like a little bit of her airway she wanted say, it made her sound little bit crackly, she did not know how to describe that. Patient stated, the symptoms seems to had subsided but as she mentioned the bruise was still on her arm she had concern about blood clotting so was taking low dose aspirin because that bruise appear, that bruise appeared 3 or 4 days later so the symptoms had 70% had resolved and 30% remained within the next day, she think was going to emergency room. Treatment, Benadryl over the counter medicine for sinus symptoms, she low dose aspirin a 81 milligram because she was concern about blood clotting incident and because she was at the bruise and she was also using a chest rub in cold and flu over the counter. There was one more thing she did use, she had can of oxygen, which athletes use, high altitude Travelers use oxygen to help them, she did use that, it helped her somewhat. Reporter seriousness for events was unspecified. The outcome of the events was unknown. Follow-up attempts are needed; Further information are requested.
53 2021-07-05 pain in extremity Within a few days to one week of receiving the 2nd dose of the COVID-19 vaccine, I noticed a sudden ... Read more
Within a few days to one week of receiving the 2nd dose of the COVID-19 vaccine, I noticed a sudden and sharp pain down my left arm, upon movement. The pain was intense, and I could feel it from my shoulder down through my arm. It lasted about 20-30 seconds. This same pain has continued to recur on a regular basis, without improvement. It occurs when I stretch my arm in certain directions, and as a result I have limited my arm movements to avoid triggering the pain. It also occurs at night while I am sleeping, sometimes keeping me awake or disturbing my sleep. And at times it occurs as I am getting out of bed in the morning. I have not been treated for this condition yet, as I have been waiting to see whether it would reduce or resolve on its own. It has now been just over two months, however, with no improvement.
53 2021-07-05 tingling, pain in extremity She was advise to go to the ER because it could be a stroke.; Tingling in her arms post vaccination/... Read more
She was advise to go to the ER because it could be a stroke.; Tingling in her arms post vaccination/ tingling started in her face and then spread; Her right eye lid was drooping a little.; She noticed a pressure on her chest including panic attacks and anxiety.; She noticed a pressure on her chest including panic attacks and anxiety.; She noticed a pressure on her chest including panic attacks and anxiety.; Soreness in arm; Lump; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional from Pfizer sponsored program. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EN6207 ), dose 1 via an unspecified route of administration, administered in top of the Arm Left on 17Mar2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in top of the Arm Right on 08Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Prior vaccinations within 4 weeks were None. Reporter then stated she did not receive any of the vaccines and she thinks she just had the tests to confirm you had it. Medical history included pain in extremity and visual impairment. There were no concomitant medications. The patient experienced she was advise to go to the ER because it could be a stroke on an unspecified date, tingling in her arms post vaccination/ tingling started in her face and then spread ( It was within 48 to 72 hours of receiving the vaccine). it initially started at the jaw bone and down into her arm midway to forearm then continued to left side of hip and down leg and stopped right above her knee, her right eye lid was drooping a little, she noticed a pressure on her chest including panic attacks and anxiety, soreness in arm, lump. It was reported that reporter has asked certain questions Has Pfizer provided a statement on the need for a booster dose (3rd dose)? Is Pfizer investigating the need for a booster dose. My pediatrician told me the vaccine is only 95 % effective against the variant. Response: The emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine has been expanded to include individuals 12 to 15 years of age. In the Phase 3 pivotal trial, there were 2,260 individuals in this age group who received either the vaccine or placebo. The dose in 12 to 15 years of age is the same dose as currently available for adults (30 mcg per 0.3 mL dose as a series of two doses). Topline results showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and the vaccine was also generally well-tolerated. These individuals will continue to be monitored for an additional two years after their second dose. Also, Pfizer has submitted this information for publication in a scientific journal for peer-review and potential publication. Pfizer and BioNTech started a Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in children aged 5 to 11 years. This is part of the Phase 1/2/3 dose-escalation study in healthy children 6 months to 11 years was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule (approximately 21 days apart) in three age groups:o 5 to 11 yearso 2 to 5 yearso 6 months to 2 yearsAdditional information about the study can be found at www.clinicaltrials.gov under the identifier NCT04816643. The Pfizer-BioNTech COVID-19 Vaccine is not authorized for use in individuals less than 12 years of age. References:Pfizer-BioNTech COVID-19 Vaccine EUA Prescribing Information Pfizer-BioNTech COVID-19 Vaccine Authorized Product Monograph. Pfizer Press Pelease. withheld 10May2021.Pfizer-BioNTech COVID-19 Vaccine. Data on file (155). Pfizer. The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On February 25, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It is important to have a vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against. While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we are taking multiple steps to be ready in case a strain becomes resistant to the vaccine. The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine is not approved. She had asked her doctor confirmed the vaccine can cause demyelination in adults post vaccination. Response: There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech. She asked What are the ingredients of the vaccine. Response: Informed caller to retrieve the list of ingredients on the following website. Sending the attached document via e-mail for reference. She was sure she does not have a stroke . Response was sent tot her to speak to her HCP. Reporter stated she had the adverse events after both the first and second doses. The outcome of she was advise to go to the ER because it could be a stroke on an unspecified date, tingling in her arms post vaccination/ tingling started in her face and then spread. it initially started at the jaw bone and down into her arm midway to forearm then continued to left side of hip and down leg and stopped right above her knee, She noticed a pressure on her chest including panic attacks and anxiety , Soreness in arm and Lump was unknown. The outcome of Her right eye lid was drooping a little was not recovered. She has to see when she goes to the doctor next week.
53 2021-07-06 burning sensation, numbness and pain in extremities The day after the 2nd vaccine, I had fever, body aches and fatigue, which lasted for 36 hours. I sle... Read more
The day after the 2nd vaccine, I had fever, body aches and fatigue, which lasted for 36 hours. I slept and took ibuprofen to help relieve the symptoms. On 1/30/2021, I noticed a burning sensation on my forehead and small pustules/blisters. It was spreading, painful and getting larger. I went to my doctor on 1/31/2021 and was diagnosed with shingles. I was prescribed valacyclovir and gabapentin. I was referred to an opthamologist since the shingles was spreading into my eye. The shingles did clear up but neuropathy remained for a month after and you continue to take gabapentin. I did go see an opthamologist and was prescribed an antibiotic eye drops for 1 week ( cannot remember name). I have not had a shingles vaccine since I don't qualify due to my age.
53 2021-07-07 weakness Shortness of breath, dizziness, neck and face redness, weakness, pain in neck.
53 2021-07-07 muscle spasms, burning sensation, numbness, muscle twitching, pain in extremity, tingling It started within four hours and I had the typical things I heard about- flu type symptoms. What I n... Read more
It started within four hours and I had the typical things I heard about- flu type symptoms. What I noticed on top of that was - low grade fever, brain fog feeling. I thought maybe that would last for a day or two. My legs felt really stiff and I had muscle cramping and I noticed I was having problems walking. That was my first concern. I had hoped that it would improve and go away but the brain fog got worse over the next few days with muscle cramping, twitching, and burning. I noticed I was feeling numbness, tingling, and stabbing in hands and feet. That continued throughout my body. I had difficulty walking, bad balance, extreme stiffness, unable to stand on feet for long periods of time, dizziness, nausea, my balance problems seemed to get worse, insomnia because of the pain. I couldn't put a blanket on my hands or feet because it made it worse. I contacted my PCP, oncologist, and rheumatologist and their initial reaction was I was having an autoimmune reaction to vaccine. I had appointments with these doctors and I had blood work ran and they didn't see anything that had changed prior to vaccine. I had all my blood work run and everything looked good at that point. There didn't seem to be anything wrong. Blood work ran was CBC, thyroid, autoimmune panel, motor sensory blood work. MY SED rate was at 5 at that point. I was taking extra strength Tylenol but it didn't help. During that period of time my brain fog continued to get worse. I was having intermittent issues with pulse rate, blood pressure, and heart palpitations. That started to increase and get worse so I called PCP and she called me over to have EKG. EKG was normal but was concerned about possibility of POTS that involves tachycardia and nervous system. She sent me to cardiology to get heart monitor and I wore that for 14 days and I'm waiting to get results back. I was also sent to neurologist because of neuropathy and he believes I have small fiber neuropathy but that hasn't been determined. He wants to wait to see if it resolves before doing skin biopsies. I seen him in September. I'm chronically fatigued. Before the vaccine I was treated for breast cancer surgery and radiation treatment and no chemo. I daily exercised, biking 15 miles, indoor cycling, walked 3 miles every day and now I cannot. My doctor does not recommend me to get the second vaccine. The pain in my hands and feet has increased. A lot of times I have thought about going to ER or hospital but my PCP said as long as I wasn't having a major cardiac event I should just be treated outpatient. If I wake up and my muscles are stiff and as long as I'm able to walk and not falling or dropping things then I basically don't go to the hospital. I want to go to hospital but I don't know what they would do for me and probably offer no guidance. My Cardiology appointment is at the end of July.
53 2021-07-07 pain in extremity Body aches, hands hurt felt swollen, muscles aches still.
53 2021-07-08 pain in extremity Sore arm; headache; This is a spontaneous report from a contactable consumer, the patient. A 53-year... Read more
Sore arm; headache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: EN5318), via an unspecified route of administration in the left arm on 23Mar2021 at 13:45 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Concomitant medications included calcium (MANUFACTURER UNKNOWN), multivitamin supplements (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: EN5318), via an unspecified route of administration in the left arm on 02Mar2021 at 08:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 12:00, the patient experienced sore arm and headache. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore arm and headache was recovered on unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.
53 2021-07-08 tingling Within 20 minutes of injection my right arm became tingly; my torso, back, both arms and neck were r... Read more
Within 20 minutes of injection my right arm became tingly; my torso, back, both arms and neck were red, itchy with a raised rash.; my torso, back, both arms and neck were red, itchy with a raised rash.; my torso, back, both arms and neck were red, itchy with a raised rash.; extremely tired; nauseous; This is a spontaneous report from a contactable Consumer. A 53-years-old (Adult 18-64Years) non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in right arm on 05Mar2021 (at the age of 53-years-old) as a single dose for covid-19 immunization. The patient medical history included asthma, allergies, cardiomyopathy, history of anaphylaxis. The patient concomitant medications were not reported. The patient had allergies with latex, penicillin, shellfish. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in right arm on 12Feb2021 at 13:15 (at the age of 53-years-old) as a single dose for covid-19 immunization. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 13:45, it was reported, "within 20 minutes of injection my right arm became tingly then within 2 hours my torso, back, both arms and neck were red, itchy with a raised rash. That evening I became extremely tired that lasted for 4 entire days. I was also nauseous for 4 days. On the fourth day the nausea was gone, the fatigue was somewhat better, but the rash is still as bad as when it began. I have been taking Benadryl with little relief". Therapeutic measures were taken as a result of pruritus and rash popular. The patient did not receive any other treatment. Outcome of the event was recovering, at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
53 2021-07-10 migraine Horrible body aches/all over body pain; extreme pain in both hips; severe migraine; nausea; diarrhea... Read more
Horrible body aches/all over body pain; extreme pain in both hips; severe migraine; nausea; diarrhea; no appetite; Fever; exhaustion; nightmares; skin sensitivity; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 25Mar2021 at 14:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN), 112 mg, from unknown date for unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: EN6199), via unspecified route of administration in the left arm on 04Mar2021 at 14:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation and clarithromycin (BIAXIN) on unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 04:00, the patient experienced horrible body aches, extreme pain in both hips, severe migraine, nausea, diarrhea, no appetite, fever, exhaustion, nightmares, skin sensitivity, literal all over body pain. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body aches, pain in both hips, migraine, nausea, diarrhea, no appetite, fever, exhaustion, nightmares and skin sensitivity was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
53 2021-07-11 burning sensation, feeling hot Dizziness; heart beating very fast; burning in my face; burning sensation on my neck and face; High ... Read more
Dizziness; heart beating very fast; burning in my face; burning sensation on my neck and face; High blood pressure; Low O2 sats; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old (Non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 13:32 (age at vaccination 53 years) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus, hypertension(controlled), hypothyroidism, chronic migraines, allergies: Penicillin, rubber sensitivity, known allergies: Latex. Concomitant medication(s) included sitagliptin (JANUVIA [SITAGLIPTIN]) taken for diabetes mellitus(Started-about one year ago); losartan (LOSARTAN) started four year ago and Ongoing taken for high blood pressure ; hydrochlorothiazide taken for hypertension Started 10 years ago and ongoing; levothyroxine (LEVOTHYROXINE) taken for hypothyroidism Started 2 years ago and ongoing; atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol Started 2 years ago and ongoing, Botox for chronic migraine (multiple injections every 3 months in the forehead and head) Last injection 09 MAR 2021 and ongoing. The patient previously took levaquin for drug hypersensitivity. The patient previously took historical vaccine within four weeks MMR Vac Live Virus SQ on left arm on 19Feb2021 (dose number 1), Zoster on right arm on 19Feb2021(dose number 1). She received the MMR and Zoster vaccine on 19Feb2021. Clarifies the Zoster is the Shingrix vaccine. On 17Mar2021 13:45 about 13 minutes after vaccine application the patient experienced dizziness, heart beating very fast, burning in my face, burning sensation on my neck and face, high blood pressure, low o2 sats. she stated that after the first dose of the Pfizer covid 19 vaccine. right after, about 6 minutes later, she got very dizzy and heart beating very fast, burning in my face, throat and neck. I've had this reaction before, not life threatening, just scary. This was different than an anxiety attack she have had that before, she never had a reaction to shots before, this was different. She would like to know if she should get the second vaccine. 6-7 minutes after the shot her heart started to beat very fast, very strong beat, then she felt very dizzy and had a burning sensation on my neck and face. A doctor was called, she monitored my blood pressure and oxygen saturation. My blood pressure was 176/96, oxygen sat was 94. The episode lasted for about 10 minutes. They monitored me for 40 minutes. She went to see her primary care provider yesterday and he said it was her decision whether to take it or not. She wants to know if she should take it. She doesn't want to have a worse reactions. The dizziness and burning started a few seconds later. Almost everything was together at the same time. She mentioned 3 and a half weeks before she received the COVID 19 Pfizer BioNTech Vaccine she received 2 other vaccines. She received the MMR and Zoster vaccine on 19Feb2021. Clarifies the Zoster is the Shingrix vaccine. She stated that she did not have an immediate adverse reaction, but had pain in both arms, a little swelling, especially with the MMR, fever, chills, and joint pain that lasted for 2 days after the vaccines. She also mentioned that she never had any reaction with any other vaccines. Her doctor didn't know if she would have more or less symptoms, she needs to know. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available)-No, she stated she never had reactions like this with other vaccines. The patient underwent lab tests and procedures which included blood pressure measurement was 176/96 (My blood pressure was 176/96), blood pressure measurement was 120/80 (Caller stated she has high blood pressure but it's controlled, which is normally 120/80, but that day it was 176/96), oxygen saturation was 94 % on (oxygen sat was 94), oxygen saturation: 98 or 99 % (Initially her O2 saturation was 94 percent, after everything resolved the oxygen level went up to 98 or 99 percent).Patient had not received any treatment for events. The outcome of events Dizziness, high blood pressure, burning sensation on my neck and face, low o2 sats was recovered on 17Mar2021. heart beating very fast, burning in my face was recovered. No follow-up attempts are needed. No further information is expected.
53 2021-07-11 migraine Developed a migraine about an hour after shot. Started feeling very tired and my throat was feeling... Read more
Developed a migraine about an hour after shot. Started feeling very tired and my throat was feeling sore. Muscle soreness started and is still present 5 days later. Next day after shot had some bad flu like symptoms; intermittent shivers and feverish. Could not get out of bed and I was so tired, yet could not get good sleep. Muscle aches and migraine headaches. Second day still was extremely tired with migraine and muscle aches with a slight stomach ache. Lost my appetite going on 5 days post shot. Took days off of work because of side effects
53 2021-07-11 migraine On 1/10/2021 at 2 pm, I developed a severe migraine headache where it hurt continuously and severely... Read more
On 1/10/2021 at 2 pm, I developed a severe migraine headache where it hurt continuously and severely for the next 30 days, and it then very slowly improved over the next 3 months. I took tylenol/caffeine so that I could move on a daily basis during the 30 days. It was so continuous that I had a doctor visit 1/21/21 where I was prescribed an anti-migraine pain medication, which I did not take. I also did not comply with the instructions to get an MRI.
53 2021-07-11 pain in extremity I received 2nd shot in L arm on Thurs, January 7, 2021 at about 5 pm. I started to have a headache a... Read more
I received 2nd shot in L arm on Thurs, January 7, 2021 at about 5 pm. I started to have a headache around 8 pm and sore arm. I went to bed early as I was to work on Friday, January 8. I started to have body aches and slight fever through the night. I woke and took two Tylenol as my temperature was about 99.9 and went to work as my temperature was under 100 degree. Through the course of the enxt two hours, I was having chills, fever, body aches, increased headache. I left work around 1045 AM. I came home with a temperature of about 101 degrees. I took two more Tylenol and went to bed. Through the day, I tossed and turned with fever, body aches and chills. I tried to stay hydrated and I could barely walk to my bathroom which was about 8 feet away. My temperature reached 102.7, my body, head hurt so bad. My hair hurt. I told my son if my fever rework ached a 103, he would need to take me to the ER. I felt slightly better Saturday but stayed in bed Sat and Sunday with fever around 99-100 degrees. I went to work Monday morning then left again in the morning since I didn't feel well. I missed Tuesday work and finally went back to work on Wednesday with slight headhache, fatigue for next week or so. Now, I got my yearly mammogram on Monday, June 28 and results came back with finding asymmetry on my left breast near my rib. I have further testing tomorrow on July 13. I have never had a bad mammogram before and have all of my annual check ups done regularly.
53 2021-07-11 tingling, flushing, numbness, flushing, numbness, tingling, tingling, numbness, flushing Flushing, numbness and tingling;
53 2021-07-12 flushing, feeling hot SOB, Elevated BP, Face flushed and warm, fatigue, chest pain
53 2021-07-12 pain in extremity fever; nausea; very sore arm; This is a spontaneous report from a non-contactable consumer, the pati... Read more
fever; nausea; very sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the right arm on 26Mar2021 at 10:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), Claritin and multi-vitamin (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 15:00, the patient had experienced very sore arm which she could not lift her arm. On 28Mar2021, the patient experienced fever and nausea. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very sore arm, fever and nausea was resolving at the time of this report. No follow-up attempts are possible; No further information is expected.
53 2021-07-12 tremor, tingling My body started to swell up including my face and my legs my arm and my throat; My body started to s... Read more
My body started to swell up including my face and my legs my arm and my throat; My body started to swell up including my face and my legs my arm and my throat; My body started to swell up including my face and my legs my arm and my throat; My legs were tingly; Felt like it was closing it didn't close but it was swelling up; My whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance; "via subcutaneous route"; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via subcutaneous route, administered in arm left in shoulder area on 06Jun2021 at 16:30 (age at vaccination was 53-years-old) (Batch/Lot Number: EW0196) as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing hay fever (I take allergy medication for hay fever you know for regular allergy). Concomitant medication included gliclazide (CLARITIN) taken for hay fever, start and stop date were not reported. Prior vaccination (within 4 weeks) was reported as no. The patient stated I just wanted to report my reaction to the vaccine for record purpose. I got the 1st shot, within few hours my body started to swell up, including my face and my legs my arm and my throat. I felt like it was closing it did not close but it was swelling up and my whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance and they put me on oxygen I could breath but I think they were just worried so they put me on oxygen, and then I spent 5 days in hospital in recovering from it, I just want you guys to know when you collect your data that this was one of the side effects. Patient also stated that her legs were tingly. The event my whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance resulted in hospitalization. Period of hospitalization was reported as 06Jun2021 to 10Jun2021 (duration 5 days). When asked patient if still experiencing events, the patient stated no, I am fine now, in the hospital they pumped with a lot of fluid and including lot of electrolyte, I had follow-up visit with my doctor and I am very healthy now I am fine, I think they just needed to flush it out of my system. The outcome of the events was recovered on an unspecified date in Jun2021. Information on the lot/batch number has been requested.
53 2021-07-13 hot flush The pharmacist wrote the wrong arm on vaccination card. I was given the vaccine on right arm, minut... Read more
The pharmacist wrote the wrong arm on vaccination card. I was given the vaccine on right arm, minutes later I felt overwhelmed by heat waves, especially on my chest, nauseous, dizzy, and felt faint. I told the pharmacist I was not feeling good. He advised to lay down on the floor. I told him to call the paramedics. He did. Upon arrival of the first responders, my blood pressure was 211. They said that due to my blood pressure been so high they would have to take me to the hospital. EKG, XRAY, Blood work was fine. When vitals was fine I was discharged.
53 2021-07-13 numbness 1st shot: bad headaches, muscle ache, dizzy, nauseated 2nd: numb fingers, bad headaches, muscle ache... Read more
1st shot: bad headaches, muscle ache, dizzy, nauseated 2nd: numb fingers, bad headaches, muscle ache, naseated
53 2021-07-13 pain in extremity I felt great until the end of May until the bones in the top and inside part of my feet started hurt... Read more
I felt great until the end of May until the bones in the top and inside part of my feet started hurting. 2 weeks later I started having jaw pain and it made it almost impossible to open my jaw. These symptoms are still happening. I have never had any joint pain ever. On 06/22/2021 I went to clinic for the pain and I was coughing as well, they told me to put compressions on my feet and they did not do any medical tests for the jaw or feet. They just gave me some medications for the cough. They just did a Covid test which was negative.
53 2021-07-14 pain in extremity Patient has had severe pain in shoulder and has had sharp shooting pains it has not stopped . it has... Read more
Patient has had severe pain in shoulder and has had sharp shooting pains it has not stopped . it has now radiated to back side of shoulder in same spt. In left arm pain has radiated down to elbow and to hand with radiating pain
53 2021-07-16 pain in extremity Starting the day after taking the 1st dose of the Pfizer COVID vaccine; I feel a lot of anxiety; rap... Read more
Starting the day after taking the 1st dose of the Pfizer COVID vaccine; I feel a lot of anxiety; rapid heart palpitations; prolonged exhaustion/tiredness, muscle/leg pain; arm soreness for the first 4 days.
53 2021-07-17 weakness mouth ulcer; Roof of mouth pain and tenderness; Low grade fever; body aches; no energy; This is a sp... Read more
mouth ulcer; Roof of mouth pain and tenderness; Low grade fever; body aches; no energy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 27Mar2021 at 13:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included that the patient was a smoker. The patient had no known allergies to food, medications, or other products. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 06Mar2021 at 13:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. On 27Mar2021, first day of vaccination, the patient had low grade fever of 99.7 (unspecified units), body aches and no energy. On 28Mar2021 at 12:00, second day of vaccination, the patient experienced ulcer in roof of the mouth, with pain and tenderness. On 29Mar2021, third day of vaccination, the mouth pain was worse. The patient reported that she was feeling better at the time of report except for mouth pain. The patient did not receive any treatment for the reported events. The event neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of the events mouth ulcer with pain and tenderness was not resolved, while that of low grade fever, body aches and no energy was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
53 2021-07-17 burning sensation, flushing Tachycardia; Feeling Faint; Flushed; Burning in Extremities; Breathless; Medicine Taste in Mouth; Th... Read more
Tachycardia; Feeling Faint; Flushed; Burning in Extremities; Breathless; Medicine Taste in Mouth; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW20042, expiration date was not reported), via an unspecified route of administration, in the left arm, on 02Jul2021 at 15:45 (at the age of 53-year-old), as a single dose, for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient's medical history included asthma, autoimmune disorders and cardiac issues. The concomitant medications were not reported. On 02Jul2021 at 21:45, patient experienced tachycardia, feeling faint, flushed, burning in extremities, breathless and medicine taste in mouth. Reporter seriousness assessed as non-serious. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not any other medications within 2 weeks of vaccination. Unknown, if the patient was diagnosed with COVID-19 prior to vaccination. Patient was not tested COVID-19 since the vaccination. Patient did not receive treatment for the events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
53 2021-07-17 involuntary muscle movements, cold sweat Blood pressure 151/120; Started getting very clammy then my left arm and leg was kicking on their ow... Read more
Blood pressure 151/120; Started getting very clammy then my left arm and leg was kicking on their own; Started getting very clammy then my left arm and leg was kicking on their own; Then two nights later had very bad stomach cramping; Diarrhea all night; This is a spontaneous report from a contactable consumer or other non Healthcare professional (patient, reported for self). A 53-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ER2613 31Jul2021), via an unspecified route of administration, administered in Arm Right at the age of 53-year-old on 25Mar2021 12:00 as dose 1, single for COVID-19 immunization. Medical history included multiple myeloma-stem cell transplant. Concomitant medication(s) (List of other medications the patient received within 2 weeks of vaccination) included pregabalin (LYRICA) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 12:00 the patient Started getting very clammy then her left arm and leg was kicking on their own. Blood pressure was 151/120 (units not reported). Then two nights later had very bad stomach cramping and diarrhea all night (medically significant). Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included blood pressure measurement: 151/120 on 25Mar2021 Blood pressure 151/120. The patient received treatment with Benadryl. The clinical outcome of the events was reported as recovering. Follow-Up (14Jul2021): Follow-up attempts are completed. No further information is expected.
53 2021-07-17 numbness Novocaine like numbness. Started at injection site up to ear, jaw then within hours whole body numb.... Read more
Novocaine like numbness. Started at injection site up to ear, jaw then within hours whole body numb.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the right arm on 24Mar2021 at 16:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Concomitant medications included acetylsalicylic acid (ASPIRIN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 17:00, the patient experienced novocaine like numbness started at injection site up to ear, jaw then within hours whole body numb and by next day it was better. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event body numbness was recovered on an unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.
53 2021-07-17 pain in extremity, tingling soreness in left shoulder; soreness in arm; soreness in upper back; headache that feels like pressur... Read more
soreness in left shoulder; soreness in arm; soreness in upper back; headache that feels like pressure; headache that feels likepressure; fatigue; tingling in face; sore swollen lymph nodes on left sideof neck; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, obesity, pars planitis (eyes). The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), acetyl salicylic acid (ASPIRIN), paracetamol (TYLENOL), fish oil (MANUFACTURER UNKNOWN), vitamins (MANUFACTURER UNKNOWN). On 12Mar2021 at 23:00, the patient experienced soreness in left shoulder, arm, upper back. headache that feels like pressure plus a tingly spacey feeling in head, fatigue, tingling in face, sore swollen lymph nodes on left side of neck. It was reported that some of effects happened first 3 days and stopped, recurred day 15, day 16, day 18 (today). No therapeutic measures were taken for the reported events. The events did not result in doctor's or other healthcare professional office/clinic visit. The clinical outcome of the events soreness in left shoulder, arm, upper back, headache that feels like pressure plus a tingly spacey feeling in head, fatigue, tingling in face, sore swollen lymph nodes on left side of neck were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
53 2021-07-17 pain in extremity Light head ache.; sore arm; This is a spontaneous report from a contactable consumer, the patient. A... Read more
Light head ache.; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) in the left arm on 26Mar2021(at the age of 53-years-old) at 19:15 as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. On 26Mar2021 at 21:00, the patient experienced, light head ache and sore arm. Therapeutic measures were not taken as a result of headache and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The The clinical outcome of the event light headache and sore arm was recovered on 27Mar2021. No follow-up attempts are needed. No further information is expected.
53 2021-07-17 pain in extremity she experienced pain almost everyday and took Ibuprofen; lot of muscle pain random, all over; all th... Read more
she experienced pain almost everyday and took Ibuprofen; lot of muscle pain random, all over; all this pressure behind my eyes; pain in my jaw; pains in my shoulder; pains in my arm; pains in my chest; I postponed it because I was in so much pain and I was still scared.; I am thinking maybe they forgot to mix it, I don't know, I am just worried.; This is a spontaneous report from a contactable consumer received from a Pfizer Sponsored Program. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809, and Expiry date are unknown), via an unspecified route of administration on 28Feb2021 (at the age of 53-years-old) as dose 1, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received Pfizer Covid-19 vaccine first dose on 28Feb2021 and 2nd dose will be on 27Mar2021 but she didn't make an appointment yet because after taking the first dose she experienced pain almost everyday on an unspecified date and took Ibuprofen. She asked, 'Should I get the 2nd dose?' 'Is pain considered a severe allergic reaction?' She received the 1st dose of the Pfizer covid vaccine on 20Feb2021. She has been experiencing a lot of muscle pain random, all over. 'Stabbing pain like someone is punching me, all this pressure behind my eyes, pain in my jaw, pain in my chest.' Stabbing pain in chest lasted 2 days on an unspecified date. She takes Ibuprofen. Sometimes the stabbing pain goes away so its hard to tell how long it lasts. She would like to know if anyone else experienced the same side effects as she did and for how long. She asked 'If they forgot to mix the saline into the vaccine, can it give you this type of reaction?' Consumer stated, "They have more advice like has it happened before like you still don't know any answers like I was thinking because they mix the Pfizer vaccine with saline and if they do not mix it will I experience something like this or like I am thinking maybe they forgot to mix it, I don't know, I am just worried." 'Do I have to restart the series if I get the 2nd dose after 30 days?' Consumer stated, "Well I am just not sure whether I should take the second vaccine or not because after the first one I had a lot of pain and it is strange pain like weird pain like pains in my shoulder, pains in my arm, pains in my chest really got into my chest on an unspecified date. I went to ER, I went to urgent care, he said it's not a heart attack but because it was like when I was moving that I felt the pain and when I am breathing in and breathing out but he said it wasn't a heart attack but he said he thought it has something to do with muscle or something but I just don't know whether I should take the second one or not, I postponed it because I was in so much pain and I was still scared because I thought the second one will be worse I have been having the effects from the first one and so I don't know what to do?" Treatment included, Ibuprofen and CBD cream and medicated patches she has been putting all over her body. Age at time of onset of reaction/event was 53 years. There was Investigation assessment. Consumer stated, "Yes, I have been getting all kind of tests, I am trying to figure out what's going on with my body so yeah I have been to urgent care, I have been to emergency, I have been to my doctor twice, I have been to the neurosurgeon, I have been had an MRI, I am having a lot of tests done." The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): inconclusive on an unspecified date, all kind of tests (investigation): unknown on an unspecified date. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
53 2021-07-17 pain in extremity Sore arm; Tiredness; Arthralgia; myalgia; fever; headache; strange dreams; Nausea; swollen gland (ne... Read more
Sore arm; Tiredness; Arthralgia; myalgia; fever; headache; strange dreams; Nausea; swollen gland (neck); This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the right arm on 09Mar2021 at 16:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and gluten allergy (Gluten sensitivity). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the right arm on 16Feb2021 at 16:45 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received other vaccines within four weeks prior to the COVID-19 vaccine. On 10Mar2021 at 01:00, the patient experienced sore arm, tiredness, arthralgia, myalgia, fever, headache, strange dreams (bizarre dreams), nausea and swollen gland in neck (gland in neck). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome for the events sore arm, tiredness, arthralgia, myalgia, fever, headache, vivid dreams, nausea and gland in neck was resolved on unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
53 2021-07-17 tingling, pain in extremity pneumonia; Chronic shortness of breath; chronic chest tightness; glassy area in lung; circulation pr... Read more
pneumonia; Chronic shortness of breath; chronic chest tightness; glassy area in lung; circulation problems with blood staining and bruising on foot; circulation problems with blood staining and bruising on foot; circulation problems with blood staining and bruising on foot; paresthesias in arms and legs; chronic body aches and pain; hand and foot pain/pain in feet; finger joints locking; headache; chronic fatigue; weakened ability to taste; Received first dose on 22Mar2021 14:30/received second dose on 22Mar2021; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Right on 22Mar2021 14:30 (at the age of 53-years-old) (Batch/Lot Number: ER8727) as single dose, second dose of BNT162B2 via an unspecified route of administration in Arm Right on 22Mar2021 (at the age of 53-years-old) (Batch/Lot Number: ER8731) as single dose for covid-19 immunization. Medical history included known allergies to Sulfa, Latex, Raynaud's, Gastroparesis, Jackhammer esophagus, migraines, asthma, fatty liver. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient was not pregnant at time of vaccination. Concomitant medications included unspecified medications. In May2021, the patient experienced chronic shortness of breath, chronic chest tightness, pneumonia, glassy area in lung, circulation problems with blood staining and bruising on foot, paresthesias in arms and legs, chronic body aches and pain, hand and foot pain, finger joints locking, headache, pain in feet, chronic fatigue, weakened ability to taste. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage and hospitalization for 2 days. Treatment received for the events and was in hospital on two separate dates. The report was serious with the seriousness criteria- caused/prolonged hospitalization and disabling/incapacitating. Since the vaccination, the patient had been tested for COVID-19, included Nasal swab on 24May2021 and 12Jun2021 both with Negative result. The outcome of the events chronic shortness of breath, chronic chest tightness, pneumonia, glassy area in lung, circulation problems with blood staining and bruising on foot, paresthesias in arms and legs, chronic body aches and pain, hand and foot pain, finger joints locking, headache, pain in feet, chronic fatigue, weakened ability to taste was not recovered.
53 2021-07-18 pain in extremity Initial reaction-sore arm and headache-lasted 2 days Another initial reaction started at 8 pm on da... Read more
Initial reaction-sore arm and headache-lasted 2 days Another initial reaction started at 8 pm on day of 1st dose-tightness in chest Got injection on Monday, 6/28/21. Tightness in chest got worse on Tuesday, Wednesday and Thursday.. It was very difficult to sleep-felt a lot of pressure when lying down. Went to a walk-in clinic on Friday-sent to ER due to an abnormal ECG
53 2021-07-18 tingling patient states left hand thumb palm area very itchy swollen feels pins and needles
53 2021-07-19 migraine After I received the vaccination within a couple of days I began to have migraine headaches. I consu... Read more
After I received the vaccination within a couple of days I began to have migraine headaches. I consulted with my physician and was prescribed Verapamil for the symptoms.
53 2021-07-19 tingling, numbness Tingling/ Slight tingling on skin all over; slight numbness on face; This is a spontaneous report fr... Read more
Tingling/ Slight tingling on skin all over; slight numbness on face; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 16:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to aspirin (MANUFCATURER UNKNOWN). Concomitant medication included omega-3 (MANUFCATURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 01Apr2021 at 16:45, the patient experienced tingling and slight numbness on face. The patient had slight tingling on skin all over. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of slight tingling on skin all over and numbness in face was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
53 2021-07-19 tingling tingly (tightness) ) on right face cheek area, forehead (right side), down cheek to the right side o... Read more
tingly (tightness) ) on right face cheek area, forehead (right side), down cheek to the right side of upper and lower lips and felt it toward right ear. Everything was on right side of face; This is a spontaneous report from a contactable consumer. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 01Apr2021 at 14:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included alpha1 carrier and migraine. It was unsure if the patient had any allergies. Concomitant medications included sumatriptan succinate (SUMATRIPTAN) indicated for migraines, multi vitamin and other unspecified medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 (also reported 02:45), the patient experienced tingly (tightness) on right face cheek area, then it went to forehead (right side), then it went down her cheek to the right side of her upper and lower lips and she also felt it towards her right ear. Everything was on the right side of face, almost exactly separated at the very center of the face. Therapeutic measure was taken as a result of event tingly and included treatment with benedryl. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tingling was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
53 2021-07-20 discomfort Pt. states that after receiving the Phizer 2nd dose 05/21/2021, 3 weeks after starting experiencing ... Read more
Pt. states that after receiving the Phizer 2nd dose 05/21/2021, 3 weeks after starting experiencing release of pressure/swelling, pain from Non-Specific Mixed Tissue Disease lessening's. States pain and pressure release lasting about a week's time. 06/16/2021 Primary visit stating possible "placebo effect".
53 2021-07-20 migraine Migraine all around my head; Dizziness to the point of falling down; Dizziness to the point of falli... Read more
Migraine all around my head; Dizziness to the point of falling down; Dizziness to the point of falling down; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 08Mar2021 13:30 (at the age of 53 years old) (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in right arm on 29Mar2021 13:30 (at the age of 54 years old) (Batch/Lot number was not reported), both as single dose for covid-19 immunization. Medical history included panhypopituitarism, hypothyroidism, bipolar 1, others. The patient had unspecified known allergies. The patient's concomitant medications in two weeks were reported as yes. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. The patient experienced dizziness to the point of falling down, migraine all around my head, extreme nausea on 29Mar2021 13:45, which were resulted in emergency room/department or urgent care. These events happened with both shots. The patient went to ER both times Treatment for events included migraine cocktail. Nothing for dizziness or nausea. The outcome of event was recovered with lasting effects.
53 2021-07-21 weakness coughing; hyperventilating; could not get her O2 sats up; felt like someone was sitting on her chest... Read more
coughing; hyperventilating; could not get her O2 sats up; felt like someone was sitting on her chest; felt really weak and tired; felt really weak and tired; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 12Mar2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. Medical history included eosinophilic asthma. Concomitant medication(s) included salbutamol (ALBUTEROL HFA), ipratropium bromide, salbutamol sulfate (DUONEB) and prednisone, all taken for asthma. The patient called because she had an interesting experience. She has a complicated medical history, she was diagnosed with high eosinophilic asthma, and takes on and off prednisone and going to see a specialist and possibly starting a new medication soon. She got the first Pfizer COVID vaccine on 12Mar2021, stated immediately after she was fine, later that night she felt really weak and tired and so she did fine the next day Saturday (13Mar2021) but was still weak and tired. It resolved by Sunday (14Mar2021). On 14Mar2021, it was hell, she was off of prednisone at the time, her asthma was acting up at the time, stated she takes albuterol and DuoNeb nebulizers as needed. On 14Mar2021, she was coughing all night, it was a different weird coughing not the same as her asthma, sounded shallow, felt like she was hyperventilating. She could not get her O2 sats up, that they were sitting around 90%, felt like someone was sitting on her chest which was not normal for her. The patient stated that the albuterol was not doing anything for her, clarified that it did help a little. The DuoNeb worked, her O2 sats went up to 94, but it was an awful night. On Monday (15Mar2021), she thought she needed to get on prednisone, took 20mg of prednisone and stated at that point she was unsure if it was her disease or the vaccine. She called doctor on 15Mar2021 for a new prednisone prescription and was unable to pick it up because the pharmacy closed, that night she had bad night. She took prednisone on Tuesday, the next morning, took 20 mg in the morning and 10mg that evening, stated that 30 will usually knock out her asthma but she had another bad night. She was really smart that she did some reading, read that prednisone could help people that have an over active immune system or it can weaken the immune system. She further reported that the previous night, she only took 10 mg of prednisone and had a great night. She has only taken 10 mg on 18Mar2021. She was doing really well on 18Mar2021. The patient asked whether she should get the second vaccine - scared to death if that was a reaction to the vaccine, secondly, was there any way to see how much immunity she has with just one shot like a test or something, to see if maybe she had COVID before. The outcome of the events felt really weak and tired was resolved on 14Mar2021 and was resolving for the rest of the events. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
53 2021-07-22 weakness Shortness of breath; dizziness,; weakness,; neck pain; redness of the face and neck; This is a spont... Read more
Shortness of breath; dizziness,; weakness,; neck pain; redness of the face and neck; This is a spontaneous report from a contactable consumer (patient self). A 53-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 28Jun2021 10:00 (Batch/Lot number was not reported) (at the age of 53-year-old, not pregnant) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. There were not any other medications the patient received within 2 weeks of vaccination. The patient previously took percocet [oxycodone hydrochloride;paracetamol] and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered in hospital. The patient experienced shortness of breath (seriousness criteria reported as medically significant), dizziness, weakness, neck pain, redness of the face and neck on 28Jun2021 10:30 and resulted in emergency room/department or urgent care. Treatment included Benadryl 50 mg -Pepcid -Medrol. Outcome of the events was recovering. Information on Lot/Batch information has been requested.
53 2021-07-22 burning sensation I experienced hives within a half hour on my chest and neck. After 9 days the hives returned on my l... Read more
I experienced hives within a half hour on my chest and neck. After 9 days the hives returned on my legs and arms with a itchy, burning sensation.; I experienced hives within a half hour on my chest and neck. After 9 days the hives returned on my legs and arms with a itchy, burning sensation.; I experienced hives within a half hour on my chest and neck. After 9 days the hives returned on my legs and arms with a itchy, burning sensation.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN#6203) via an unspecified route of administration in the left arm on 21Mar2021 at 11:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 50 mcg from an unknown date for unspecified indication. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in the right arm on 28Feb2021 at 14:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 00:00 the patient experienced hives within a half hour on chest and neck. After 9 days on 04Apr2021, the hives returned on legs, arms with itchy and burning sensation. The patient did not receive any treatment for the adverse events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events hives, itchy and burning sensation was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
53 2021-07-22 pain in extremity After receiving the first COVID-19 vaccine dose I have experienced severe joints pain and joints sti... Read more
After receiving the first COVID-19 vaccine dose I have experienced severe joints pain and joints stiffness. Also, for a week I had excessive tiredness. More concerning is the postmenopausal bleeding. After 15 months of menopause I started bleeding, having a full period cycle with all the PMS symptoms. The period continued for the next two months.
53 2021-07-25 pain in extremity Pain in both legs, swelling, and pain in joints both legs, knees, ancles an hips.
53 2021-07-27 weakness, feeling of body temperature change lost of taste; chills (cold and hot); getting cold and hot; lack of energy; feeling nauseous; This i... Read more
lost of taste; chills (cold and hot); getting cold and hot; lack of energy; feeling nauseous; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Jun2021 (at the age of 53-years-old) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus wife is diabetic. The patient's concomitant medications were not reported. On 28Jun2021, the patient experienced lost of taste, chills, getting hot and cold, lack of energy, feeling nauseous. The outcome of the events was unknown.
53 2021-07-27 burning sensation Higher heart rate; loss of appetite; Burning of skin all over; Fatigue; Joint pain; Headache; Inject... Read more
Higher heart rate; loss of appetite; Burning of skin all over; Fatigue; Joint pain; Headache; Injection site pain; Fever; Chills; Muscle pain; Feeling unwell; Lymph node swelling; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 14Mar2021 at 14:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included PASC (Post-acute Sequelae of COVID-19). Patient had no allergies to medications, food, or other products. Concomitant medications included celecoxib (CELEBREX) 200mg for 2 times a day and salbutamol (ALBUTEROL INHALER) as needed, both from unknown dates for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 29Mar2021, the patient underwent SARS-CoV-2 (nasal swab) and the result was negative. On 15Mar2021 at 00:00, the patient experienced joint pain, fatigue, burning of skin all over, headache, injection site pain, fever, chills, muscle pain, feeling unwell, lymph node swelling, loss of appetite and higher heart rate. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. . The clinical outcome of the events of joint pain, fatigue, burning of skin all over, headache, injection site pain, fever, chills, muscle pain, feeling unwell, lymph node swelling, loss of appetite, higher heart rate was recovered with sequelae on an unknown date. No follow-up attempts are needed. No further information is expected.
53 2021-07-27 migraine Migraine; joint pain; muscle pain; body ache; joint stiffness; muscle stiffness; This is a spontaneo... Read more
Migraine; joint pain; muscle pain; body ache; joint stiffness; muscle stiffness; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 03Apr2021 at 10:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroidectomy, asthma, atrial fibrillation and tomato allergy from an unspecified date. Concomitant medications included gabapentin (MANAFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN methocarbamol (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took INDOCIN, TAGAMATE, ALEVE, phenobarbital (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:00 the patient experienced migraine, joint pain, muscle pain, general body pain, joint stiffness, muscle stiffness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events migraine, joint pain, muscle pain, general body pain, joint stiffness, muscle stiffness was resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.
53 2021-07-27 pain in extremity, cold sweat, tingling trouble sleeping; didn't feel very good; soreness in her arm; hurt like a regular kind of needle; ho... Read more
trouble sleeping; didn't feel very good; soreness in her arm; hurt like a regular kind of needle; hot and cold sweats; hot and cold sweats; headache; swelling; This is a spontaneous report from contactable consumer. A 53-years-old adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0176) via an unspecified route of administration, administered in left arm on 23May2021 at 17:30 as Dose 1,Single for COVID-19 immunization. The patient's medical history included ongoing factor v deficiency, COVID-19 in March 2020. The patient's concomitant medications were not reported. It was reported that, when patient got the first shot, patient did not felt very good after getting it and had the soreness in her arm, it did not really hurt at the injection site when they did it, it hurt like a regular kind of needle. The patient was getting hot and cold sweats after getting it and had a mild headache Patient did not felt good. She only probably slept 2 hours a night for the first whole week that time in Jun 2021 because her head was killing her and it wouldn't let her sleep. Trouble sleeping is still ongoing, its gotten better, it's improved, but its still not good. The patient underwent lab tests including Antibody test with No antibodies found in Oct 2020 and COVID-19 test resulted positive on an unspecified date. The outcome of headache was resolving and hot and cold sweats and trouble sleeping was not resolved The outcome of events didn't feel very good, soreness in her arm, hurt like a regular kind of needle, swelling, chest pain and hot and cold sweats was unknown. No further information was provided.
53 2021-07-27 pain in extremity Left armpit pain; Feels like swollen lymph nodes; Nausea; Chills; Left arm pain; Dose 2 administrati... Read more
Left armpit pain; Feels like swollen lymph nodes; Nausea; Chills; Left arm pain; Dose 2 administration date 23May2021; Dose 2 administration date 23May2021; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received second dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: EW0185) via an unspecified route of administration in left arm on 23May2021 at 15:00 (at the age of 53-years-old) as single dose for COVID-19 immunization. Medical history of the patient included Hyperactive bladder from an unknown date and unknown if ongoing. Patient had no known allergies. Other medications (concomitant) in two weeks included mirabegron (MYRBETRIQ) taken for an unspecified indication, start and stop date were not reported; solifenacin succinate (VESICARE) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. Patient previously received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: unknown) via an unspecified route of ad-ministration in left arm on 31Mar2021 as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 23May2021 at 17:00, patient experienced left armpit pain, feels like swollen lymph nodes, nausea, chills, left arm pain. Treatment received in response to the events included Motrin. Outcome of the events Left armpit pain, feels like swollen lymph nodes, nausea, chills, left arm pain was not recovered. Follow-up attempts are needed. further information is expected.
53 2021-07-28 numbness and pain in extremities I am a 3 year cancer survivor that has neuropathy from chemo. My neuropathy was getting much better ... Read more
I am a 3 year cancer survivor that has neuropathy from chemo. My neuropathy was getting much better until I had the second dose of the Pfizer vaccine. The pain has intensified in my feet and hands ho; I also have only 50% of my taste and smell since the last vaccine that I was given; I also have only 50% of my taste and smell since the last vaccine; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (at the age of 53-years-old) , via an unspecified route of administration, administered in the Left arm on 25Feb2021 16:15 (Batch/Lot Number: EN6203) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing (patient diagnosed with COVID-19:Yes), cancer survivor from an unknown date and unknown if ongoing (3 year cancer survivor) and had ongoing neuropathy from chemo. Patient had no known allergies and past drug history. The patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no any other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (04:15 PM) (lot number: EN5318) (at the age of 53-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient reported that she was a 3-year cancer survivor that had ongoing neuropathy from chemo. Her neuropathy was getting much better until she had the second dose of the Pfizer vaccine. The pain had intensified in her feet and hands horribly (medically significant) on 26Feb2021 06:30. The patient also had only 50% of her taste and smell since the last vaccine that she was given on 26Feb2021 06:30. The events did not require treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
53 2021-07-28 night sweats Slight fatigue; muscle aches; sharp bone pain when tossing/turning at night; Sharp Pain in elbow; Sh... Read more
Slight fatigue; muscle aches; sharp bone pain when tossing/turning at night; Sharp Pain in elbow; Sharp Pain in ribs when rolling over in bed.; Fever; Night sweats (very alarming); This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 11:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included Sensitive to adhesives (like band aids). Concomitant medications included ibuprofen (ADVIL) for unknown indication taken 2 days before she took the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 13:00 the patient experienced slight fatigue, muscle aches, sharp bone pain when tossing or turning at night, sharp pain in elbow, sharp pain in ribs when rolling over in bed, fever 101-103.5 and night sweats but then she felt great the next morning. The patient did not receive any treatment for the events. On 04Apr2021, the patient underwent body temperature and the result was 101-103.5. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events slight fatigue, muscle aches, sharp bone pain when tossing or turning at night, sharp pain in elbow, sharp pain in ribs when rolling over in bed, fever and night sweats were recovered on an unknown date in Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
53 2021-07-28 pain in extremity Extremely tired and leg pain . went to doctor on 7/29 and blood clot was found.
53 2021-07-28 pain in extremity Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 53-year... Read more
Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on 01May2021 at 11:15 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. It was unknown if the patient was diagnosed with COVID-19, prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021, the patient experienced headache and sore arm. The clinical outcome of the events headache and sore arm was recovered on an unspecified date in May2021. No follow-up attempts are possible. No further information is expected.
54 2021-01-01 weakness Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe head... Read more
Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe headache, muscle and joint pain, chills, fever (temperature-102.8),and exhaustion. Redness, pain, and swelling at injection site that has continued to worsen even after 48 hours. Could not perform regular activities of daily living. I could not drive home from work the day after the injection because the adverse reactions were getting more severe, especially after the 24 hour mark. Treatment: treated my symptoms at home with medications (I am a nurse), after researching possible adverse reactions. I figured there was not anything someone else would to treat me besides treat my symptoms.
54 2021-01-01 pain in extremity Body aches, fatigue, arm pain(first couple of days), diarrhea and nausea
54 2021-01-02 tingling Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, a... Read more
Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, arms, legs, lips, face, mouth. Started Friday morning January 1st 2021. I went to the ER on Friday January 1st 2021 and was given Prednisone. I'm still having symptoms today Sunday January 3rd 2021.
54 2021-01-02 tremor 5pm 12-29-2020 slight headache, that lasted through Wednesday evening, 12-30-2020. Thursday, 12-31-... Read more
5pm 12-29-2020 slight headache, that lasted through Wednesday evening, 12-30-2020. Thursday, 12-31- 2020, no adverse reaction. Friday, 1-1-2021 , entire body, including internal organs were trembling. Saturday, 12-31-2020, extremley dizzy, unable to stand, function. Nauseated, extremely dehydrated, extreme exhaustion. This lasted 24 hours. Sunday, 1-3-2020, still exhausted, but not to extreme. All other symptoms have subsided.
54 2021-01-03 weakness 12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with lo... Read more
12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with low-grade fever, chills, nausea, weakness and elevated blood pressure 165/104, which had come down by the afternoon to 155/95
54 2021-01-03 tenderness I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of ... Read more
I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of shot. Mild lower back pain that evening (vaccine on left arm and pain on same side). On 12/30 soreness was only to palpation. Rhinorrhea all day long, took NyQuil, moderate back pain, took naproxen and did some back stretches. On 12/31 no sore arm but little tender. Increased back pain , used back brace , took naproxen not that much help though. used heat pack finally fall asleep around 3 am. on 01/01/2121 around 6 am woke up with excruciating left lower back pain, could not move, get off the bed. took a while to get off the bed. Have to drag my legs very slowly to walk. Went to ER. X-ray did not show anything. In ER took Narco 5 and Baclofen. MD thinks that it might not be side effects of vaccine. But I wonder, I never had left lower back pain before. Taking Baclofen and Advil TID since 0101/2021. 01/04 still in pain. increase pain after 6-7 hours after meds. Sitting or standing more than 30 mins Increases pain. Going to see PMD today
54 2021-01-04 weakness, pain in extremity chills fever muscles pain joint pain headache arm pain difficulty of breathing weakness dizziness fa... Read more
chills fever muscles pain joint pain headache arm pain difficulty of breathing weakness dizziness fatigue tiredness
54 2021-01-04 pain in extremity When I first received shot my left arm start hurting. I was in contact with someone that had COVID-1... Read more
When I first received shot my left arm start hurting. I was in contact with someone that had COVID-19 , which I was tested positive with COVID-19.
54 2021-01-04 tremor she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/Sh... Read more
she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/She just took it now and it is 100.4 degrees Fahrenheit; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer reporting for herself. A 54-y ears-old female patient received bnt162b2 (BNT162B2) vaccine, intramuscular in the right arm on 23Dec2020 07:00 at single dose for covid-19 immunisation . Medical history included covid-19 from Jul2020 to an unknown date. There were no concomitant medications. The patient experienced chills on 24Dec2020 with outcome of recovering , nausea on 23Dec2020 23:00 with outcome of recovering , headache on 24Dec2020 with outcome of recovering , running temperature at 100.4 degrees Fahrenheit on 24Dec2020 with outcome of not recovered , feeling unwell on 23Dec2020 with outcome of not recovered , resting heart rate went to 130 on 24Dec2020 with outcome of recovering , she could not stop shaking on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.8 Fahrenheit; 99.2 Fahrenheit, 100.4 Fahrenheit, heart rate: 130 (66-72. Normally) , sars-cov-2 test: negative on 21Dec2020 , sars-cov-2 test: negative on 24Dec2020 . Information on the lot/batch number has been requested.
54 2021-01-05 weakness, night sweats, pain in extremity positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); ... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); night sweats; Soreness at injection site; slight temp 99.5 degrees/her temperature was 101 degrees Fahrenheit/it was 102.5 degrees Fahrenheit/99 degrees Fahrenheit and then 98 degrees Fahrenheit; Tiredness she related to giving blood; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular on 19Dec2020 15:45 on left deltoid at a single dose for prevention as frontline health worker at hospital (COVID-19 immunisation). The patient donated blood on 18th and no antibodies were present then. The patient was a former smoker and quit 2 or 3 years ago. Patient diagnosed Osteoporosis in 2015, benign heart arrhythmia in 2005. The patient took 70 mg alendronate sodium (FOSAMAX) once weekly and just a regular OTC daily multivitamin. Caller reported she was having the covid vaccine on 19Dec2020 and began having fever, night sweats, loss of taste and smell and then tested positive for covid. The patient received the Pfizer COVID 19 vaccine through work on 19Dec2020. She received it at 3:45 pm and should have taken temperature before, but she was afebrile the day before because she donated blood. At 7pm, she had slight temp 99.5 degrees Fahrenheit and by 10:30, her temperature was 101 degrees Fahrenheit and she still felt fine. She was surprised that it was that. She woke up at 2:30 am on 20Dec2020 and took her temperature and it was 102.5 degrees Fahrenheit. She took 2 Tylenol and went back to bed and felt fine. By morning it was 99 degrees Fahrenheit and then 98 degrees Fahrenheit a little later. She has been afebrile since then. She was a little tired because she gave blood and though it was related. She does not know if it was a side effect or not. It was not significant tiredness and was just not having energy in the evening of 19Dec2020. She also had soreness at injection site that night after 22:00 and the next day. It did not bother her until she woke up in the middle of night, and she noticed her left arm was sore. She received the vaccine at 3:45pm and started with low grade fever at 6:30 pm, earlier stated at 7:00 pm. There was no prescriber. She tested for COVID (PCR) on Saturday, 26Dec2020 at 14:50and it came back positive 28Dec2020 18:45. At 10pm on 19Dec2020, her temperature was 101 degrees Fahrenheit. If she had not been monitoring her temperature, she would not have known. She has been Afebrile since morning of 20Dec2020. Tiredness she related to giving blood and the holidays. She was a little stressed about the holidays and running around. It was very mild. Soreness at injection site was during the night after 10pm when she went to bed. On Wednesday, 23Dec2020, she woke up congested, sniffly, sneezy, with a runny nose. This persisted through Wednesday night. Her sense of taste was off. She had no problem with that on Tuesday. She had some horrible smell at work she recalled, so she knew her sense of smell was fine. On Thursday, 24Dec2020, she had no sense of taste or smell. She could not smell a pine candle. She was congested on Thursday and called employee health on 24Dec2020. This both improved and persisted. She is still congested but it has improved. She has never had a complete loss of sense of taste or smell before. Mild cough started yesterday morning. On the night of 20Dec2020, and 21Dec2020, she developed night sweats. She had not had any night sweats before this since menopause and she woke up really wet. The patient was not hospitalized and not admitted to an Intensive Care Unit. NO ER or physician's office required. She did not know if she was exposed on the day of the vaccine or if a couple of days later if the fever is from the vaccine. She stated what are the chances she goes 10 months and is super careful and then gets the vaccine and test positive. The patient did not display clinical signs at rest indicative of sever systemic illness. The patient did not require supplemental oxygen nor receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID- 19. No initiation of new medication or other treatment or procedure. Not any preexisting diseases worsen during the SARS-CoV2 infection. She would like to know if there is a chance of false positive for this. It would just be her luck to be 10 months and not getting it. She has not gone anywhere without her N95 and then gets the vaccine and gets COVD. She wears mask and face shield at work always. She also wanted to know if she should get the second dose. The outcome of the event slight temperature was recovered on 20Dec2020 and the other event was recovering.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.
54 2021-01-05 flushing, feeling hot LEFT SIDED CHEST PAIN, SHORTNESS OF BREATH, FELT WARM AND FLUSHED
54 2021-01-05 hot flush, tremor, feeling hot About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme he... Read more
About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme heat or hot flash, shaking, almost hyperventilating but was able to control breathing. Episode lasted 10 mins Immediately with vaccine I noted an antiseptic taste in my mouth and this continues.
54 2021-01-05 pain in extremity, tingling I received the covid vaccine in my left arm yesterday morning at 8:00 am. I felt fine until noon w... Read more
I received the covid vaccine in my left arm yesterday morning at 8:00 am. I felt fine until noon when my arm became sore, which I expected to happen so I took Tylenol. By mid afternoon, my 4th and 5th finger on my left had began to tingle and I was having difficult typing with that hand on my keyboard. By late afternoon, the left side of my face began to tingle like paresthesia. I took more Tylenol at dinner but the sensation in my face lasted until I went to bed around 10:00. I woke up in the night and my face felt fine but my 2 fingers were still tingling and I felt like I had no control over them. When I woke up this morning, I took to more Tylenol and the symptoms have subsided. Also, when the nurse swabbed my arm with alcohol, I asked?Isn?t that a little high for the injection, and he said no?it?s right in the deltoid. It felt like the injection site was close to the bones in my shoulder but that may have had nothing to do with these symptoms.
54 2021-01-05 pain in extremity PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THA... Read more
PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THAT SPREAD TO ENTIRE UPPER BODY. SHOOTING PAINS UP HER NECK AND DOWN HER ARMS. DEVELOPED ITCHY RASH ALL OVER UPPER BODY AS WELL AS HEADACHE AND SWOLLEN LYMPH NODES. CRP WAS 3.6 AND SED RATE 25. COVID TEST WAS NEGATIVE. PATIENT PUT ON MEDROL DOSE PACK AND SYMPTOMS RESOLVED IN 5 DAYS
54 2021-01-05 pain in extremity patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joi... Read more
patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics. Pain radiated through her upper body and at times was shooting. she was unable to perform ADLs. She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes. Covid test was negative, CRP was 3.6 and sed rate was 25. all other labsl WNL, symptoms resolved after 5 days
54 2021-01-05 pain in extremity After vaccine patient reported ankle, leg and hip pain. Taking Motrin
54 2021-01-05 tingling Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands ... Read more
Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands and forearms. Approximately 15-20 minutes after injection. Tingling in feet and lower extremities. Thirty minutes after injection slight itching at injection site. Approximately 1 1/2 hours after injection splotchy red skin inside both thighs and mild generalized itching. At 2:00 pm that day of injection tingling began in face with slight swelling in cheeks. Itching lasted 3 days. Currently intermittent itching since Monday 01/03/2021.
54 2021-01-06 numbness, feeling cold, tremor her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her le... Read more
her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID. The patient medical history included Primary Essential Tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it. The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020. The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-01-06 numbness shoulder pain... which didn?t seem connected to the vaccine... which progressed to pins and needles ... Read more
shoulder pain... which didn?t seem connected to the vaccine... which progressed to pins and needles in the L shoulder, numbness into both hands...of the left arm. And neck pain... cervical radiculopathy in the L arm... pain and pins/needles into L thumb. It reached its peak with 4 nights of disturbed sleep starting on the date mentioned. I didn?t keep track of the symptoms other than that because I didn?t initially associate the symptoms to the vaccine until early this week. Symptoms have since improved and are (almost) resolved; I was advised to have the the 2nd vaccine today as scheduled - which was recommended lower on the deltoid and on the opposite shoulder.
54 2021-01-06 migraine with aura pain/swelling at injection site (expected) worsening of regular joint pain in addition to new joint ... Read more
pain/swelling at injection site (expected) worsening of regular joint pain in addition to new joint pain ocular migraines (had aura 3 or 4 times that next week, this is something I do not experience frequently, hadn't had one for at least 15 years prior to the vaccine
54 2021-01-06 pain in extremity Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th ar... Read more
Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th arm was very sore, runny nose, shoulder/neck aches, severe N/V/D, severe fatigue Narrative: Did not need to seek medical care. Stayed at home.
54 2021-01-06 tremor, pain in extremity Fever, chills, headache, dry cough, left calf pain, tremor in left thumb
54 2021-01-07 weakness, cold sweat dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; c... Read more
dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; cold-clammy skin; headache; exhaustion; nausea; Redness and swelling at injection site that is still getting more severe after 48 hours; Redness and swelling at injection site that is still getting more severe after 48 hours; This is a spontaneous report from a contactable nurse reporting for self. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899, intramuscularly from 30Dec2020 13:00 (age at vaccination: 54 years old) at single dose in left arm (dose 1) for COVID-19 immunization. There was no other vaccine administered in the 4 weeks prior to COVID vaccination. The patient was not pregnant. Medical history included hypertension, arthritis, degenerative disc, CRPS/RSD, thyroid cancer, thyroidectomy during 2007, and Crohn's disease. Known allergiesincluded insect stings and environmental allergies. The patient had COVID prior to vaccination. Concomitant medication included thyroid (THYROID); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); meloxicam (MOBIC); vitamin D; alpha lipoic acid (ALPHA LIPOIC ACID); duloxetine hydrochloride (CYMBALTA); and pantoprazole sodium sesquihydrate (PROTONIX). Within 24 hours of receiving COVID vaccine, the patient experienced dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, and nausea, from 31Dec2020 at 08:00. These continued to worsen over the next 24 hours. Redness and swelling at injection site that was still getting more severe after 48 hours. The patient was unable to drive home from work the day after injection due to adverse reactions getting worse throughout the day. The patient self-treated at home with medications (not further specified). The outcome of the events dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, nausea, and redness and swelling at injection site were not recovered. The events were reported as non-serious. The patient was not COVID-tested post-vaccination.
54 2021-01-07 weakness, pain in extremity chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; diz... Read more
chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; dizziness; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient (not pregnant at the time of report) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EL 3246) on 04Jan2021 12:00, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EK 5730) on 18Dec2020 11:00, both intramuscularly on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included migraine, known allergies: kiwi. Concomitant medications were not reported. The patient experienced chills, fever, headache, muscles pain, joint pain, difficulty of breathing, arm pain, tiredness, dizziness and weakness, all on 04Jan2021 19:00. Treatment received for all events included Ibuprofen, Alive. The outcome of all events were not resolved.
54 2021-01-07 feeling cold body chills aches and headace
54 2021-01-07 feeling hot Warm neck and face. Burning sensation in eyes.
54 2021-01-07 feeling jittery About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. ... Read more
About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. She was in the parking garage and called 911. She was taken to ED and treated with IV fluids. Her potassium was low and was replaced. Felt better after fluids and was discharged
54 2021-01-07 pain in extremity Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ p... Read more
Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ pain in her arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Right Upper Arm on 03Jan2021 (around 9:15 to 9:30AM) at single dose for COVID-19 immunization. Medical history included ongoing lupus (diagnosed about 2-1/2 years before 04Jan2021) and fatigue with lupus. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient said later in the evening of 03Jan2021, she got pain in her arm she got the COVID-19 Vaccine. She received her first check-in call after receiving the COVID-19 Vaccine, and at that time she had no pain in her arm. She clarified the pain in her arm at the injection site started in the evening of 03Jan2021. On 04Jan2021 she had fatigue. She stated she got fatigue sometimes with her lupus. No treatment received for the adverse events. No emergency room or physician office involved. The patient reported she saw her rheumatologist and had blood work done. The outcome of pain in arm at the injection site was recovering, of fatigue was not recovered. The information on the batch number has been requested.
54 2021-01-07 pain in extremity some arm pain (unspecified) following the injection; shoulder and neck stiffness after going to slee... Read more
some arm pain (unspecified) following the injection; shoulder and neck stiffness after going to sleep that night; This is a spontaneous report from a non-contactable nurse. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on 03Jan2021 (Sunday) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The nurse reported some arm pain (unspecified) following the injection on 03Jan2021 and shoulder and neck stiffness after going to sleep that night. The nurse reported that her arm pain resolved the next day on 04Jan2020. The outcome of event "shoulder and neck stiffness after going to sleep that night" was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
54 2021-01-07 pain in extremity Symptoms - ? EE reports she received her vaccine during work yesterday and then worked until approxi... Read more
Symptoms - ? EE reports she received her vaccine during work yesterday and then worked until approximately 8:00 PM. EE reports arm soreness and pain at injection site. EE reports she woke up around 04:00 with flu like symptoms, body aches (reporting so bad she is barely able to get out of bed), fever (Tmax 101.4). + runny nose, congestion and headache. EE reports + exposure to pt with only wearing surgical mask approx. 3 weeks, and was contacted by EH and was considered low-risk and not scheduled for testing. Last day of work and shift - ? yesterday left work at approx. 8:00 PM Home remedies? - Tylenol at 0700, 600 mg ibuprofen at 11:30 Any improvement? - none Recommendation? After completely algorithm, EE meets criteria to be COVID tested and removed from work at this time. EE provided with EH command center and instructions to notify them need for COVID-19 testing. EE educated to notify his manager. EE verbalized back understanding and denied further questions at this time.
54 2021-01-07 tingling right arm started tingling about 15 minutes after vaccine. Rash started on left wrist/forearm area. ... Read more
right arm started tingling about 15 minutes after vaccine. Rash started on left wrist/forearm area. Took Benadryl and Zyrtec...symptoms subsided.
54 2021-01-07 tremor Symptoms started 1/5/2021 around 6:00pm lasted about 36 hours. headache mild fever fatigue Lt calf p... Read more
Symptoms started 1/5/2021 around 6:00pm lasted about 36 hours. headache mild fever fatigue Lt calf pain tremors on Lt thumb - until today still with mild tremors episodes of dry cough
54 2021-01-08 numbness, tingling Had COVID vaccine #1. Developed a numbness and tingling sensation in hands and legs at 10:45a. Deni... Read more
Had COVID vaccine #1. Developed a numbness and tingling sensation in hands and legs at 10:45a. Denies any rash, mouth/throat swelling, difficulty breathing, itching, wheezing, or racing heart. Check vitals: O2 98% HR 72 BP 118/80 Monitored until 11:20. Rechecked periodically and her symptoms resolved. Advised that if symptoms return then go to ER. Discharged home.
54 2021-01-08 migraine 12/31--slight headache that morning, by that evening migraine level headache 01/01/21-early morning ... Read more
12/31--slight headache that morning, by that evening migraine level headache 01/01/21-early morning fever 101.9, severe chills, severe aches of lower back, hips, joints, loss of appetite these symptoms continued thru 01/02/21 01/03/21 fevere abated, still body aches but much less severe, fatigue 01/04/21 fatigue only slowly resolving
54 2021-01-09 feeling hot Headache, Myalgia, Arthralgia, NauseaVomiting, fatigue, feeling hot Narrative:
54 2021-01-09 hot flush Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-l... Read more
Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-like sx) with first dose. She began experiencing feeling like she was outside of her body about 10 min after receiving her booster. BP was taken and was slightly elevated 140s/90s. Ice packs were provided for hot flashes. Warm blankets provided for chills. BP was trending up to SBP 160s then started to decline to normal. Patient was accompanied to restroom by clinic staff and was able to walk without incident. Patient was observed in covid clinic for total of 2 hours and reassured that she was not likely to have worsening of sx at this point. Patient was walked to mother's car by clinic staff and left feeling better. 1/10 - patient presented to ED with low grade fever (100.4), chest pain, severe joint and muscle pain, nausea and "fog brain." She reports BP being 187/101 in ED. Given 1L of normal saline, zofran, toradol, and dilaudid. Observed until BP drcreased to SBP 140s. Nausea improved enough to allow her to eat. Labs were WNL, CK normal. Discharged home with diagnosis of "adverse effect of COVID-19 vaccine"
54 2021-01-09 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Beginning the day of vaccine, very sore upper left arm for 2 d... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Beginning the day of vaccine, very sore upper left arm for 2 days. Moderate headache beginning on day after vaccine, lasting for one day.
54 2021-01-10 hot flush Within minutes I became flush and very hot. My heart starting racing. I had blood pressure check an... Read more
Within minutes I became flush and very hot. My heart starting racing. I had blood pressure check and heart rate.
54 2021-01-10 muscle spasms, pain in extremity, numbness Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps ... Read more
Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps in arms and legs. Feelings of restless, stomach upset. Knee charley horses.
54 2021-01-10 pain in extremity Fever and headache next day; sore arm next day; headache and sore arm lasted through 1/11/21
54 2021-01-10 pain in extremity Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she descri... Read more
Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she described arm pain that radiated up to her left jaw and chest. At this time we recommended she be escorted to the Emergency Department for assessment. This was completed and she was later released home without any longstanding concerns.
54 2021-01-10 tingling, numbness, flushing, feeling hot 30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and... Read more
30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and tingly, she passed out at her desk and was taking to the ER for evaluation. Benadryl & Solumedrol Admin with hydration with NS. Pt discharged from ER. Pt in ~10am discharged from ER ~2hrs later.
54 2021-01-10 cold extremities Rigors, hands and feet felt frozen Temp spikes up to 103.7 lasted 2 days
54 2021-01-11 weakness crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; havi... Read more
crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; having no energy; feeling tired/Tiredness; kidney stone; pain in her back; did not feel good; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140) intramuscular on 31Dec2020 16:00 at a single dose on left arm for Covid-19 prophylaxis. Medical history included rheumatoid arthritis. There were no concomitant medications. The patient wanted to know if she could receive the second dose of the COVID-19 vaccine if she presented the following side effects with the first shot: feeling tired/tiredness on 02Jan2021; having no energy on 03Jan2021; muscle pain, joint pain, and flu like symptoms/feeling like she has the flu, on 04Jan2021. She went to work on Monday and has taken the last couple of days off because she did not feel good on Jan2021. She did have rheumatoid arthritis, but it was different and has not been like this. She went to the doctor on Monday after she got off of work and thought at first maybe she had a UTI; treated herself with AZO, but had a urinalysis that was negative on an unspecified date. She was told some of the pain in her back might have been a kidney stone on Jan2021 because they found crystals in her urine on 04Jan2021, but she did not know about that. She noticed having no energy on Sunday. She wanted to know if it was recommended that she get the second vaccine since she was having side effects. The events required a visit to physician office and did not require a visit to Emergency Room. Prior vaccinations within 4 weeks was noted as none. Family medical history relevant to the events (AE) was noted as none.The outcome of the events of feeling tired/tiredness was not recovered; of having no energy, muscle pain, joint pain, flu like symptoms/feeling like she has the flu was recovering; of the rest of events was unknown.
54 2021-01-11 bell's palsy Bell's Palsy
54 2021-01-11 flushing Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right... Read more
Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right after injection for 2 days Moderate Pain at the injection site for 5 days Muscle weakness and aches, mild for 2 days Difficulty with concentration Feeling tired for a few weeks
54 2021-01-11 migraine I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that ... Read more
I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that helped. A little soreness at the injection site nothing extraordinary. I had the vax on a Monday and the last migraine I had was maybe on Friday the same week. I received the second dose yesterday and now I have a headache, low grade fever (99.9F about 8AM this morning) and body aches. Just treating myself at home. The headaches I have now are different, in a difference place in my head, they are lighter, it feels more like the headache you have when you have fhe flu.
54 2021-01-11 night sweats Stomach cramps, bowel cramps, malaise, bloating, loose stools, night sweats, nausea, headache, dizzi... Read more
Stomach cramps, bowel cramps, malaise, bloating, loose stools, night sweats, nausea, headache, dizziness, joint pain
54 2021-01-11 pain in extremity, hot flush Approximately 2 hours after the vaccine, I had flushing feeling, no elevated temperature. Arm soren... Read more
Approximately 2 hours after the vaccine, I had flushing feeling, no elevated temperature. Arm soreness, nausea. I also checked my b/p. It was more elevated than usual. (130/90?s). These symptoms subsided 24-48 hours after the vaccine.
54 2021-01-11 pain in extremity I had soreness in my left arm for 2 days. Muscle aches for 1 day. I had a headache on 12-24-2020. I ... Read more
I had soreness in my left arm for 2 days. Muscle aches for 1 day. I had a headache on 12-24-2020. I also had chills on 12-25-2020 with muscle aches. The muscle aches got worse on 12-26-2020 and that's when I visited an urgent care center. At the ER they did a nasal swab test, covid test.
54 2021-01-11 pain in extremity HA resolved with Tylenol. Achy, chills and arm soreness resolved with Ibuprofen. All symptoms comple... Read more
HA resolved with Tylenol. Achy, chills and arm soreness resolved with Ibuprofen. All symptoms completed resolved.
54 2021-01-11 pain in extremity rash on her belly and torso area; Left arm soreness; This is a spontaneous report from a contactable... Read more
rash on her belly and torso area; Left arm soreness; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1686) via an unspecified route of administration in left arm on 28Dec2020 11:15 at single dose for COVID-19 immunisation. There was no medical history. The patient only takes vitamins; has no underlying conditions. There were no concomitant medications. 20 years ago, the patient had flu like symptoms after the Flu vaccine. Last vaccine was a Tetanus shot 8-10 years ago. The patient received COVID-19 vaccine through hospital on 28Dec2020 at 11:15 in left arm. Left arm soreness noticed in morning on 29Dec2020. Forty-eight hours later (15:00 on 30Dec2020) had a rash on her belly and torso area. Rash was no where else. Is due to get second dose on 18Jan2021. She wants to know if it is OK to receive second dose. Clarified she is referring to the Pfizer COVID-19 Vaccine. Clarified soreness was noticed only in the injection arm. Was noticed in morning. Noticed rash at 15:00 on 30Dec2020. She took benedryl x 3 doses and the rash and symptoms were gone on 31Dec2020. Event outcome of rash on her belly and torso area was recovered on 31Dec2020, while for others was unknown.
54 2021-01-12 weakness NAUSEA AND VOMITING, WEAKNESS AND DIZZINESS, FATIGUE, SORE MUSCLES
54 2021-01-12 cold sweat, pain in extremity Vaccine was given 1/12/21 at 10am, 3pm having chills and slight sore on L arm, 6pm chills continues... Read more
Vaccine was given 1/12/21 at 10am, 3pm having chills and slight sore on L arm, 6pm chills continues and head pressure ( took Tylenol ) 8pm body aches, stiffness back of my neck, soreness on L arm worsen. Next morning 1/13/21 L side arm, back and neck stiff, soreness and backaches, and also chills, hands are clammy and headache.
54 2021-01-12 pain in extremity, feeling cold Chills and headache. Took extra strength Tylenol for the headache shortly after going to bed (around... Read more
Chills and headache. Took extra strength Tylenol for the headache shortly after going to bed (around 10pm). Still felt a slight headache the next morning (5:30am) and took two more tablets. Felt fine after that. I felt kind of cold during the evening, but by the time I went to bed around 10pm, that was when the chills had hit full force. I could not get warm enough. I continued to increase the temperature of my electric blanket and was not comfortable until I was at a 6 out of 10. When I woke up the next morning the chills were gone. Also experienced soreness in the left arm.
54 2021-01-13 feeling cold Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing,... Read more
Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing, shooting pain in right parotid glands; General feeling of unwellness; This is a spontaneous report from a contactable nurse. A 54-years-old female patient started to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL0142, on 06Jan2021 (at the age of 54-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included chronic granulomatous disease. Concomitant medication were unspecified. The patient previously received the first dose of BNT162B2, Lot number: EK5730, on 17Dec2020, administration time: 08:00 AM, in the left arm for covid-19 immunization. The patient previously took Oxacillin and Levaquin and experienced allergies. The most recent COVID-19 vaccine was administered in the workplace clinic. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 07Jan2021 09:30, the patient experienced arm soreness, huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellnessThe events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness was recovered. Since the vaccination, the patient has not been tested for COVID-19.
54 2021-01-13 flushing c/o dizziness, SOB, hives, "flushed"
54 2021-01-13 muscle spasms TEMP LOSS SENSE OF TASTE BODY ACHES, MUSCLE CRAMPS, FATIGUE SEVERE HEADACHE DIZZINESS LIGHT HEADED
54 2021-01-13 pain in extremity Fever of 101 degrees, severe headache, fatigue and bodyaches. Chills and nausea. Severe right arm ... Read more
Fever of 101 degrees, severe headache, fatigue and bodyaches. Chills and nausea. Severe right arm pain. Took tylenol and tramadol for pain and fever.
54 2021-01-13 pain in extremity I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within... Read more
I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within 24-48 hours ~ except the Right Axillary Lymph Node Swelling and Pain ~ This is still currently present, please let me know if you want me to let you know when this last symptom/reaction resolves?) Fatigue Sore Right Arm (injection) Chills Fever Headache Cough Right Axillary Lymph Node Swelling and Pain
54 2021-01-13 pain in extremity Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 54-ye... Read more
Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0140, expiration date unspecified), via an unspecified route of administration on 22Dec2020 at 13:30 at single dose at left arm for COVID-19 immunization. Medical history included hypertension and hypothyroidism. The patient had no known allergies and no allergies to medications, food or other products and patient was not pregnant. The patient's concomitant medications were not reported. On 22Dec2020 at 13:30, the patient experienced sore arm. There was no therapy received for the event. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had other medications that was received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of event was recovered on an unspecified date.
54 2021-01-13 pain in extremity Rash and redness around injection site Arm soreness Chills Fever
54 2021-01-13 pain in extremity Arm soreness
54 2021-01-13 pain in extremity sore arm, headache,fuzzy head, neck pain, body aches, insomnia, tiredness, and just not feeling we... Read more
sore arm, headache,fuzzy head, neck pain, body aches, insomnia, tiredness, and just not feeling well
54 2021-01-13 tenderness, pain in extremity 1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this... Read more
1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this document 1/14/21 08:00 07:30 increased dry cough, scratchy throat 08:30 sore throat 09:30 mild headache and muscle aches, sore throat, cough when talking 10:30 increasing muscle aches and headache, laryngitis, cough resolving, mild intestinal discomfort 11:00 left work 11:30 all symptoms at 10:30 continuing, increasing fatigue; took 1000mg acetominophen slept most of the time noon - 4 pm 4pm cough resolved, muscle aches continued, headache improved, laryngitis continued. mild fatigue 6:00 pm noted loss of smell (could not smell cooked garlic - my husband could) Laryngitis & muscle aches continued throughout evening 7:30 pm 2nd dose 1000mg acetaminophen 1/14/20 - 06:00 am laryngitis resolved Ongoing scratchy throat, mild muscle aches, mild nausea/intestinal discomfort. Laryngitis and cough mostly resolved - but i am not talking much; speech is an irritating factor for both symptoms. Fatigue improved. Headache mostly resolved. Took 1000 mg acetaminophen.
54 2021-01-13 tremor, feeling cold She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; s... Read more
She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; shake/her hands were shaking so hard; they took her temperature and it was 100/her fever went to 101/temperature had gone to 102.6; heart rate was elevated at 100/heart rate was 110/heart rate went to the high 120s; headache; backache; nauseated; chest was hurting; The initial case was missing the following minimum criteria: Invalid for unspecified adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration in deltoid left on 29Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history included ongoing sleep apnoea (diagnosed about 3-4 years ago, wear her CPAP religiously), Hashimoto's hypothyroid, and chronic low vitamin d (lack of sunlight). Concomitant medication included levothyroxine sodium (SYNTHROID) from 2016 and ongoing for Hashimoto's hypothyroid, ergocalciferol (VIT D) from 2018 for chronic low vitamin d; lack of sunlight (She did not take it religiously, but was supposed to take it everyday). At 10:30 AM (29Dec2020), she started to get cold and shake. She thought that this was insane and it was in her head. It became so severe she could not use her computer her hands were shaking so hard. She went back up to where they were giving vaccines, they took her temperature and it was 100. It had been normal the morning before she got the vaccine. Her heart rate was elevated at 100. They put a blanket on her and said they wanted to watch her for 15 minutes. In that time her fever went to 101 and her heart rate was 110. They took her to the ER. She was there for 5 hours. Her heart rate went to the high 120s. They did a 12 lead EKG. Her temperature had gone to 102.6, which was the highest. They gave her a liter of Normal Saline. She also had a headache, backache, and felt nauseated. The liter of fluid helped, no doubt. She was not admitted. She was wiped out the next day (30Dec2020) with aches and pains still. Their concern was they said they did not give her epinephrine because her heart was too high. She had no breathing issues. Just extreme cold. At one point she had woke up in the ER (29 or 30Dec2020) and her chest was hurting, she knows from her heart rate being too fast. She was so cold. She had on 6 blankets. The next day (30Dec2020) she still had the aches and pains, she was tired, and had brain fog. It all went away on 30Dec2020. She had nothing after that. What scared her was the heart rhythm. The ER doctor says its not great, but felt that getting the second dose was better than her having COVID. The Electrophysiologist she saw, said she was unsure if she should get the second dose. The hospital said that for this next dose, they would give her the injection, wait 15 minutes, then send her home, expecting that she would have the same thing happen. When after the first dose, she was in the ER on a 12 lead EKG with an intravenous (IV). She had no arm pain the whole time. The reporter assessed all events related. She felt fine prior, walking in to get the vaccine. But she was much better the next day and recovered completely. She was just worried about the second dose. The outcome of events was recovered on 30Dec2020.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-01-14 weakness Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She ... Read more
Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She felt a sudden weakness from head to toe and felt an impending sense of doom. She began to feel dizzy and panicked. EE moved to evaluation area at 1333. HR78 BP 174/96 O@ 97%RA. Pt was anxious and noted BP was high for her. FNP continued chatting to EE. EE declined the ED at this time. A&O x4. 1350 HR 75 BP 151/94 O@97%. EE reports feeling much beter. EE opted to wait in the observation area an additional 30 minutes, declining again to go to ED for further evaluation. EE will call if her condition changes.
54 2021-01-14 facial paralysis 1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen,... Read more
1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen, headache and chills by afternoon mouth and right eye was drooping. Was prescribed RX prednisone on 1/15/2021. Current symptom (1/15/2021) is mouth drooping, other swelling and eye drooping resolved. Reports has occurred twice before. About 7 years ago with unknown etiology, lasted for about 6 months, Occurred again about 5 years ago with unknown etiology and lasted about one month.
54 2021-01-14 flushing, cold sweat Patient's heart felt racing, started to get clammy and flushed 10 minutes after receiving the vaccin... Read more
Patient's heart felt racing, started to get clammy and flushed 10 minutes after receiving the vaccine.
54 2021-01-14 mild one side paralysis Headache neck pain Dec 28 , 29, then extreme muscle weakness in right leg and right hand . The weakn... Read more
Headache neck pain Dec 28 , 29, then extreme muscle weakness in right leg and right hand . The weakness in my right hand had become progressively worse since dec 30 or 31 st . Had the second shot on Jan 11 . In last 2 data I am having trouble holding a mug or iPhone in right hand . It feels very numb From Jan 12 to today my right hand is having trouble gripping pen , hair brush , difficult to open doors .
54 2021-01-14 numbness, feeling cold, tremor I waited for 30 minutes; I walked to my car and didn't feel well; I thought maybe I was hungry I ate... Read more
I waited for 30 minutes; I walked to my car and didn't feel well; I thought maybe I was hungry I ate 1/2 banana and drank some water. I started to drive home. It felt like a huge cold railroad spike was being driven up the top of my shoulder to my neck, it was a cold sensation anteriorly and posteriorly on my neck. Then my face (left side) started to go numb, it started just about the top of my left ear and went all the way to my lips. It stopped midline. It felt like a dental block. I could still swallow and breathe. I started shaking, felt nausea, my upper esophageal sphincter started to spasm. I kept checking my tongue and airway to see if I should pull over and call 911. I drove to the ER. My left side of face was numb, I was trembling, tremoring. They gave me small dose of IV Bendadryl (12.5 mg) and Pepcid, I slowly started to feel better and the feeling came back to my face moving from midline lip to cheek. It still felt "funny" but much better. I was in the ER for around 2 hours. I have had more tremoring since my vaccine in my neck and hand (I do have primary essential tremors but it is tremoring much more now) and more neck pain (could be due to the increased tremors)
54 2021-01-14 pain in extremity Fever 100.4, headache, nausea, body aches, right arm soreness
54 2021-01-14 pain in extremity Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hour... Read more
Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hours. Mysugar climbed to 250 by dinner time. By bed tme my sugar was 300. I did not eat dinner. I had no appectite. I increased my insulin and metformin dose. I had chills and fevery thru the night and the next day. High fever 101. I treated this with tylenol and showers. I was really sleepy all day. I had little to eat and still my sugar was 300 most of the day. on Jan 6. I woke up and had a hemmorrhage in my right eye. I called my retinol specialist and and received an injection of Eylea on Jan 7, 2021
54 2021-01-14 pain in extremity Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose... Read more
Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose was 89 in the morning. by 1400 hours my glucose was 250. By bed time it was 300. I did not eat dinner and adjusted my insulin and took an extra 500mg metformin. I had chills and fever through the night and all the next day. Fever 99 to 101. Tylenol and showers used to control fever. I was very sleepy all that day. I was sleepy with the first shot also. I woke up on Jan. 6, 2021 with a hemorrhage in my right eye. I called the retinol specialist and was given a shot of Eylea in my right eye Jan. 7, 2021., He asked that I report this advers reaction.
54 2021-01-14 pain in extremity Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, head... Read more
Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Nauseous with injection.; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), intramuscular at left arm on 08Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included migraine and No known allergies. Concomitant medication included sumatriptan succinate (IMITREX), fluoxetine hydrochloride (PROZAC). The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization at right arm on an unknown date. The patient experienced nauseous with injection on 08Jan2021. Next day (09Jan2021), she had sore arm, neck, body, headache, tired chills, afebrile. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information about lot and batch number was requested.
54 2021-01-14 tingling, pain in extremity 12/3 flu shot; employer made me get the shot. I started with burning nerve pain, neuropathy, in feet... Read more
12/3 flu shot; employer made me get the shot. I started with burning nerve pain, neuropathy, in feet to legs. I called office and put on prednisone for 3 days. Then another 7 days prescribed; 12/23rd 1st vaccine; The same day, I was having the tingling and pain came back after the shot. But I still had had from flu shot, it just came on stronger. It wasn't as bas as after the flu shot. Took another 10 days of prednisone. 1/13/2021 2nd vaccine; sore arm, little tired. But could be as I had to wake up early.
54 2021-01-14 tremor, numbness 1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SV... Read more
1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SVT with first dose of some new medications. Pt reports intermittent SVT and PVCs post ablasion. HR 136, regular rhythm. 1828: 176/101 (119), HR 108, Resp 22, 99% on room air Pt reports feeling like her HR is returning back to normal, hand tremors continue. Reports mild shortness of breath, which is typical with her SVT episodes. 1831: 151/82 (98), HR 81, regular rhythm, Resp 12, 98% on room air. Denies any worsening or any additional symptoms. Hand tremor no longer present. 1839: 151/104 (113), HR 76, regular rhythm, Resp 10, 98% on room air. Pt reports headache and mild nausea that is typical with her SVT episodes. Pt appears relaxed sitting in chair. 1845: HR 78, regular rhythm. Pt remaining in monitoring area for 15 additional minutes. No s/s further distress. Pt calling husband to take her home. 1905: BP 157/91 (107), HR 87, regular rhythm, 98% on room air, Resp 14 Pt c/o numbness to L arm with some L chest tightness. Reports this sometimes happens with her SVT episodes. 1907: No further chest tightness or L arm numbness. Pt reports feeling anxious. Does not want to go to the ED for further monitoring. Continues to report that her symptoms feel typical after her SVT episodes with some additional nausea. 1910: 132/112 (117), HR 78, regular rhythm. Pt reports improvement of symptoms. Pt relaxed in chair. Instructed pt to stop and call 911 if she has any concerning symptoms after leaving clinic including difficulty breathing or HR abnormalities.
54 2021-01-17 weakness I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed... Read more
I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed. I woke up again at 6:30 with the same horrible headache not relieved at all by Maxalt so I took another dose. I had vertigo so I went back to bed. I woke up at 8:00 still with the horrible headache and vertigo but had horribe nausea. I never vomited. I felt weak all day, had no appetite and my neck felt very stiff all day. In the evening my knees were aching. The next day I continued to have a mild headache and neck stiffness.
54 2021-01-17 feeling cold Fever, chills, body aches, malaise, headache
54 2021-01-17 pain in extremity 54-year-old female presents for evaluation and treatment of right arm pain. Received the 1st dose of... Read more
54-year-old female presents for evaluation and treatment of right arm pain. Received the 1st dose of her covid-19 vaccine on 01/07. She initially had some soreness but that resolved over the following days. Her pain returned couple of days ago and has been significantly worse. She has not noticed any systemic signs of illness. No darkening of her urine. She has tried heat and ice. She took 1 dose ibuprofen. Pain is radiating up to her shoulder. It is worse with any kind of movement. Recommend ibuprofen 400 mg 3 times a day and given the muscle soreness will treat with a muscle relaxer.
54 2021-01-18 flushing Flushed, elevated heart rate
54 2021-01-18 migraine, pain in extremity Fever; Severe chills; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips,... Read more
Fever; Severe chills; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips, joints,; started with slight headache by that evening migraine level headache; started with slight headache by that evening migraine level headache; Fatigue; This is a spontaneous report from a contactable other-HCP (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient is not pregnant. The facility type vaccine was hospital. Medical history included degenerative disc disease, obesity, high cholesterol, high blood pressure, migraines. The known allergies included adhesive, mango, banana, compazine, demerol, codeine. Concomitant medication included gabapentin and meloxicam. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue on 29Dec2020 with outcome of recovered, started with slight headache by that evening migraine level headache on 31Dec2020 with outcome of recovered, fever on 01Jan2021 early am with outcome of recovered, severe chills on 01Jan2021 with outcome of recovered, severe aches low back, legs, hips, joints on 01Jan2021 with outcome of recovered. The outcome of event was recovered in 03Jan2021, other events were recovered in 02Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
54 2021-01-18 night sweats severe headaches; night sweats; severe bone crunching chills; light headedness/feeling faint; fever;... Read more
severe headaches; night sweats; severe bone crunching chills; light headedness/feeling faint; fever; muscle and joint ache/pain; muscle and joint ache/pain; nausea; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162b2 (lot: EK 9231), via an unspecified route of administration in left arm on 26Dec2020 12:30 at single dose for covid-19 immunization. Medical history included subclinical hypothyroid, Premature ventricular contractions (PVC's), Migraines. Concomitant medication included metoprolol succinate (TOPROL), fesoterodine fumarate (TOVIAZ), levothyroxine, omeprazole, "multi v". The patient experienced severe headaches, night sweats, severe bone crunching chills, light headedness/feeling faint, fever, muscle and joint ache/pain, nausea on 28Dec2020 02:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received the urgent care, lab tests for these events. The patient's results of covid tests (Nasal Swab, covid swab) were Negative on 31Dec2020 and 05Jan2021. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
54 2021-01-18 pain in extremity sore arm for 24-48 hours...like a bruise, but it didn't keep me from doing anything.
54 2021-01-18 tingling Body aches, Chills, fatigue, joint pain, arm tingling, sneezing. Took Tylenol and Claritin
54 2021-01-19 inability to speak On Sunday, January 17, 2021 I started having severe joint pain in my wrists, elbows, knees, hips and... Read more
On Sunday, January 17, 2021 I started having severe joint pain in my wrists, elbows, knees, hips and shoulders. Along with aching all over. Over the course of the day, I started to feel bad. Then on Monday January 18, 2021, in addition, to the joint pain, I started feeling disoriented, dizzy like spells of vertigo. I went to my PCP who did lab work and all was normal. He said it muse be delayed reaction to the vaccine. Later in the day, I was having difficulty putting words together and more dizzy and very lethargic. I laid down and slept until the next morning. (Tuesday 1/19/21) On Tuesday 1/19/21, they symptoms were improved but still had some dizziness. On Wednesday 1/20/21, the symptoms have improved except for an occasional dizzy spell.
54 2021-01-19 flushing Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest ... Read more
Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest pain, palpitations--Treated with EpiPen onsite, Ambulance--Epi/O2/Monitoring---ER IV benadryl/ IV Solumedrol/ IV dexamethasone--Sent home 5 hrs later with oral benadryl and predinsone
54 2021-01-19 pain in extremity 2 days after infusion, severe arm pain and fever, body aches, and extreme nausea (unable to eat any... Read more
2 days after infusion, severe arm pain and fever, body aches, and extreme nausea (unable to eat anything). Started on 1/6 in morning and gone by night of 1/6.
54 2021-01-20 pain in extremity sore and swollen left arm within a couple hours, later same day some fatigue, next day some aches, ... Read more
sore and swollen left arm within a couple hours, later same day some fatigue, next day some aches, and low grade temperature. Mild headache started suddenly around 8 hours after injection and continued for about 16 hours.
54 2021-01-20 tingling Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identifie... Read more
Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identified herself to staff. She stated that she usually takes Benadryl when she has these symptoms. She had an elevated blood pressure at the time (BP= 180s/110s. She proceed to take 50mg Benadryl. Approximately 20 minute later, she developed coughing and continued tingling of her perioral area and that the tingling was extending to her nose and forehead. At which time, she said that she would use her Epipen at such a time. She self administered an Adult Epipen. Approximately 10 minutes, her symptoms improved. She continued to cough and have elevated BP. She was transported via EMS to the nearest ER in stable condition.
54 2021-01-21 weakness SORENESS AT SIGHT, NO ENERGY/ SWOLLEN LYMPH NODES
54 2021-01-21 flushing, difficulty speaking, tingling, numbness Shortly after receiving vaccine developed flushing, numbness, tingling, coughing, horseness, wheezin... Read more
Shortly after receiving vaccine developed flushing, numbness, tingling, coughing, horseness, wheezing, difficulty breathing. Transported to ER
54 2021-01-21 numbness It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food ... Read more
It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food (never found out what the allergen was). About 20 minutes after receiving the vaccine, my throat felt strange, my sinuses started getting congested, my ears started plugging. I felt dizzy when walking. I spent extra time at the clinic under observation. About 40 minutes after receiving the vaccine, I suddenly felt like I was being sucked into a vacuum and thought I was going to pass out. I alerted the nurses, who checked my vital signs and put me on O2. My heart rate was normal, my BP was high, my O2 sat was 100%. After about 5 minutes I started to feel normal, they removed the O2. They continued to observe me for another 15 minutes, until I felt better. As I drove home (about 1 hour 10 min after receiving the vaccine), my face and lips became numb. I continued driving home and the numbness resolved in about 10-15 minutes. I notified my doctor of the event and she advised me not to get the second dose and to report the event.
54 2021-01-21 muscle spasms, numbness Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk... Read more
Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk (like a spasm). There was no twitch the a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body) . I also had bilateral jaw pain (not sure if its was because I was in so much pain in the legs that I was clenching my teeth) I also had slight numbness on by left face and by the evening I had redness on my left cheek but it went away. My face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw.
54 2021-01-21 pain in extremity Extreme arm soreness, body aches, joint pain, headache, chills , congestion, runny nose, and fever u... Read more
Extreme arm soreness, body aches, joint pain, headache, chills , congestion, runny nose, and fever up to 100.9 even on Tylenol. Symptoms were more than moderate. Had to alternate Tylenol and Advil every 3 hours for fever. Arm soreness started just hours after shot and hurt even when arm was stationary. Other symptoms started overnight and lasted through the next night. Received shot We?d at 4:30 and took until Friday for major symptoms to subside. Still with some congestion, runny nose and tiredness as of today (Friday).
54 2021-01-21 tremor was extremely tired and could not stay awake fell asleep at 10 am for 5 hours to wake at 3 pm with s... Read more
was extremely tired and could not stay awake fell asleep at 10 am for 5 hours to wake at 3 pm with slight low blood sugar , known by slight tremor in hands and body and also resolving 30 min after eating proteins and drinking orange juice. A few hours later around 5pm began getting headache, ate dinner and did not resolve so I took 100mg of Tylenol . could not sleep and was awake until 1am woke at 930 am with low sugar again resolved after eating and drinking orange juice. Had a headache less severe only took 500 mg of Tylenol it resolved. Stayed awake all day was fatigued. no other remarkable symptoms the rest of the day. the next day was about the same only less severe and by the fourth day I only noticed being tired during the day. I think it resolved completely by the 7th or 8th day I lost track due to my step mother coming out of rehab after having had COVID in December. as I write this I am fine and it is 1/22/21
54 2021-01-22 difficulty speaking, pain in extremity, tingling, numbness Received vaccination at 11:10. Waited 12 minutes in observation and left because felt fine. At 11:45... Read more
Received vaccination at 11:10. Waited 12 minutes in observation and left because felt fine. At 11:45 while driving home, experienced numbness and tingling in my whole face like receiving a novacaine injection at the dentist. A few minutes later experienced tachycardia. A few minutes later, experienced a walnut sized lump in my throat that was more evident with swallowing. Voice was also raspy, but did not experience any difficulty breathing. Got off the highway and went to a hotel lobby to call 911 as my cell phone battery was about to die. This was around 12 noon. BP was 160/94 which is high for me; usually runs 90-95 systolic. Was transported to the ER. Next BP was 150/84. Upon arrival to the ER, the symptoms described had not worsened. Was discharged later that day around 5 PM. No treatment was administered. The next day, arm very sore, had joint aches and felt tired. By 1/23/2021 had mild arm soreness without other symptoms.
54 2021-01-22 pain in extremity Fever, chills, body aches, fatigue, left arm pain, nausea
54 2021-01-23 pain in extremity The day after injection I had the normal soreness of left arm, achiness , and fatigue that lasted al... Read more
The day after injection I had the normal soreness of left arm, achiness , and fatigue that lasted all day. At approximately 6:00 pm I noticed some red spots on my abdomen and by 10:00 pm the rash/hives had spread all over my abdomen. The next morning (Friday 1/22/21) it had spread to my chest and back areas and small areas on my legs. A PA recommended I take Zyrtec and Pepcid. I called my PCP's offices and they recommended I continue doing that. Saturday I continued to have rash all over and itchiness and some soreness. I went to an Urgent Care at 5:30 pm) and the PA there gave me a shot of epinephrine and called in a Rx for a stronger antihistamine. Today, Sunday (1/24/21) I still have the rash/hives. I'm not sure what Rx was called in, I have to pick it up this morning.
54 2021-01-24 breast pain, pain in extremity Very sore right arm radiating under my arm, neck, and right breast area. Very tender to palpate lym... Read more
Very sore right arm radiating under my arm, neck, and right breast area. Very tender to palpate lymph nodes under right arm and neck. Tender right breast as well. Symptoms from the first night after the second vaccine and still 13 days later.
54 2021-01-24 numbness, tingling, difficulty speaking Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg ... Read more
Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg before bed last night and then took 10 mg Zyrtec before getting the shot. She states about 15 mins after administration she began to have numbness and tingling of her hands, forearms, lower legs, neck, face and lips. She came to ER was monitored for a few hours, about 3 hours post administration while in ER her voice became more hoarse and she noticed edema under her eyes bilaterally. Pt was given 25 mg IV bindery and remained under observation for another 1.5 before being DC. She maintained airway the entire time, VSS and AOX4;
54 2021-01-24 pain in extremity I had a sore arm for the day and then it was gone. Sunday morning, I woke with my face hot and red w... Read more
I had a sore arm for the day and then it was gone. Sunday morning, I woke with my face hot and red with a rash on my chin, forehead and left cheek. The second week, my chin started burning and my face was covered in a dermatitis rash. I saw the dermatologist for this.
54 2021-01-24 pain in extremity Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm... Read more
Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm to hand. Started 1/20/2021 and continues to worsen. Pain unbearable.
54 2021-01-24 pain in extremity On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continu... Read more
On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continued x 4 days, then, local tenderness persisted for additional week. Onset of HA 1/18/21 through 1/25/21 for 6 of the 7 days, for a few hours duration and relieved with Aleve qd to BID. On 1/22/21 noticed Left shoulder muscle weakness, visible atrophy of muscle and dull pain in shoulder/ arm and neck. Clicking in the joint with rotation movement. Spoke to Director of Rehab and advised to contact CDC and seek medical care. Call placed to PCP 1/23/21 with office closed for weekend. Due to non-urgent symptoms, opted to wait for appointment on Monday. Continued pain and symptoms through the weekend with feeling of instability in the shoulder. Spoke to CDC for Q/A on 1/24/21 and sought medical attention with appointment for care on 1/25/21.
54 2021-01-24 tingling, numbness, pain in extremity, tenderness The evenin of receiving vaccination I felt "normal" discomfort; pain, tender to touch and movement. ... Read more
The evenin of receiving vaccination I felt "normal" discomfort; pain, tender to touch and movement. The following morning I felt pain/discomfort radiating from should downward but also felt a tingling/numbing sensation radiating down left arm. Arm tingling subsided by end of day of 1/20/21, however, two fingers continue to have a tingling/numbing sensation - ring and middle finger of left hand
54 2021-01-25 discomfort I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid... Read more
I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid-19 and I was having some of those symptoms- very painful headache, terrible lower back pain , very tired, upset stomach and sore at injection site. I couldn't get comfortable . I started taking 3 Tylenol ES, Ibuprofen 800mg, and Pepto Bismol at same time every 4 hours. After about 18 hours I started feeling normal. The testing site told me some people are having reactions.
54 2021-01-25 feeling hot, feeling cold After about between 10 to 15 minutes of the shots, started feeling hot and cold symptoms of your abo... Read more
After about between 10 to 15 minutes of the shots, started feeling hot and cold symptoms of your about to pass out. Then tightness of chess where its hard to breath. EMS were around to give me 2 shots of Epi one at a time with the interval of about 5 to 15 minutes. the first Epi was OK but still having hard time breathing and the second one feels a lot better but cant stop shivering's. then I was transferred to emergency room and treated also with some allergy med. (Benadryl administer through IV)
54 2021-01-25 flushing, tingling Face became flushed after approx. 15 mins. Also had slight tingling in left arm (arm of the injecti... Read more
Face became flushed after approx. 15 mins. Also had slight tingling in left arm (arm of the injection). No flush or rash on the body. Symptoms subsided with a couple of hours
54 2021-01-25 flushing Felt flushed and nauseated
54 2021-01-25 pain in extremity axillary was tender and occasionally painful; 50 cent size lump on the side of her arm at injection ... Read more
axillary was tender and occasionally painful; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; patient received the covid vaccine on the 30Dec had a sore arm; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 30Dec2020 at single dose on the arm for COVID-19 immunization. The patient medical history included "had classic symptoms of COVID, but had a negative COVID test" on Dec2020. Concomitant medications were not reported. The patient previously had a Tetanus vaccine 23 years ago. After receiving patient spiked a fever 101 and cellulitis at the site. Reporter explained she is not 100 percent sure. She is not sure if the nurse used the DTap abbreviation and truly administered the Tetanus shot. Reporter indicated she is not sure which preparation patient got. Patient received the vaccine on 30Dec2020 and her arm was sore that day when went to bed. The next morning (31Dec2020) the site was tender. She then noticed a nickel size (as reported) red lump that had disappeared on 03Jan2021 (The next day she had tenderness and redness that went away after two days). Patient noticed the 50 cent size (as reported) lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site the morning of 31Dec2020, an exact time was not specified. On 07Jan2021 he had a 50 cent size lump on the side of her arm at injection site in arm received injection that was raised, warm, red, and tender at the injection site. On 07Jan2021 her axillary was tender and occasionally painful. On 08Jan2021 it returned to injection site at 1. That day at 6:30 PM on 08Jan2021 she had an area she had a 50 cent size area that was raised, red, and warm. She took Benadryl the next day. The morning of 09Jan2021 she woke up and had more redness tenderness in her arm, therefore, she called her doctor. Her doctor ordered an antibiotic. On 11Jan2021 they entered in the follow-up notes she had slow improvement even though the axillary area is still painful. Reporter explained it sounds like events are slowly improving, they are not completely resolved. Reporter stated it is so weird that the sore arm went away, disappeared, and then came back again. The final outcome of the events was recovering. The adverse events di not require a visit to the emergency room or physician office. The events were as assessed as non-serious by reporter. The causality of events was considered as related by reporter. Information on the Lot/Batch number has been requested.
54 2021-01-26 feeling hot I had a bullseye rash about 7cm circular and 5 inches below the injection site that was red and hot.... Read more
I had a bullseye rash about 7cm circular and 5 inches below the injection site that was red and hot. It was there for two days and went away. I had a 2.5cm hot spot on my chin and the left cheek saw red and hot.
54 2021-01-26 feeling hot I had a red hot rash on my face that lasted about a week. During the night, I woke to my face cover... Read more
I had a red hot rash on my face that lasted about a week. During the night, I woke to my face covered all over after being clear at bedtime.
54 2021-01-26 pain in extremity Myalgia FEVER, Left arm the night of vaccination, then body aches, feverish, lethargic and 1/24 star... Read more
Myalgia FEVER, Left arm the night of vaccination, then body aches, feverish, lethargic and 1/24 started with left axillary pain; symptoms are slowly improving Narrative
54 2021-01-26 pain in extremity Shortly after injection my arm felt was sore as if I just had a flu vaccine. Approx 1930 my arm then... Read more
Shortly after injection my arm felt was sore as if I just had a flu vaccine. Approx 1930 my arm then felt as if I just had a tetanus booster then followed by chills, body aches, had 100.5-101 fever (on Friday). Chills on Friday resolved while taking Tylenol as well as body aches. continued with Tylenol 1000mg every 6 hrs. Saturday woke up with no fever, chills body aches resolved.
54 2021-01-26 cold extremities 1638: Lightheadedness - Reports happening with 1st shot as well. BP 136/60. HR 53. Given water. ... Read more
1638: Lightheadedness - Reports happening with 1st shot as well. BP 136/60. HR 53. Given water. 1651: no symptoms BP 111/86, HR 54 1705: Hands colder than normal 1708: observed for 30 minutes; BP 127/68; HR 53; still cold hands. off balance, neck pain. 1717: continues to report feeling off and didn't wan tto leave. moved to chair for more observation and given crackers. 1726: Warming up, felt normal, felt okay to leave. Release home.
54 2021-01-26 tremor, weakness, flushing Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little we... Read more
Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little weak. Thought I was imagining things. Walked outside took elevator to the car felt increasingly more dizzy and weak. Got to car and started it, drove a few feet then knew it was dangerous to drive. parked and called My husband. He alerted people he knew . I then called 911. Symptoms progressively worsened. Thought I was going to code. Went to Er by ambulance. Trembling, dizziness, fast heart rate continued. Felt like i was going to die and my heart was going to jump out of my chest. In emergency room, they did an ekg and chest X-ray which were normal. They did some blood work. My potassium was very low ? 3.3. My TSH was 0.05; glucose 108;auto absol basos 0.1. Other results were normal. They told me the reaction was due to my low potassium and TSH levels. ER doctor recommended to change my levothyroxine dose with my pcp. Was in ER from approximately 1 pm - 6 pm on 1/7/21. They had me drink potassium and sent me home. Some symptoms subsided but still felt weak and dizzy when I left.
54 2021-01-27 migraine Dizziness; Severe migraine; Nausea; Blurred vision; This is a spontaneous report from a contactable ... Read more
Dizziness; Severe migraine; Nausea; Blurred vision; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL3246, expiry: unknown), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose in the workplace clinic for COVID-19 immunization. Medical history included lupus SLE and known allergies with Stadyl. Concomitant medications included ascorbic acid (ESTER-C [ASCORBIC ACID]) and prednisone. The patient had no other vaccine in four weeks. The patient experienced severe migraine, blurred vision, dizziness and nausea on 12Jan2021 at 14:00. The patient was tested for Covid prior to vaccination but was not tested post vaccination. The events were not treated. The outcome of the events was recovering.
54 2021-01-27 pain in extremity She noticed redness, itchy swelling around the injection site, along with a sore arm and a shotty ly... Read more
She noticed redness, itchy swelling around the injection site, along with a sore arm and a shotty lymph node in the right axilla
54 2021-01-28 discomfort her body felt uncomfortable; had pain at injection site for a little bit; muscle soreness/muscle sor... Read more
her body felt uncomfortable; had pain at injection site for a little bit; muscle soreness/muscle soreness in left arm at injection area after receiving the second dose; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, expiration date: May2021), intramuscular on 12Jan2021 09:00 at 0.3 mL, single on left arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received her first dose of BNT162B2 on 22Dec2020 around 08:15am to 08:30 am, intramuscular injection in left arm. The dose she received was 0.1ml (lot number: EH9899). The patient received flu shot on Nov (no year reported). The patient experienced headache on 12Jan2021 and muscle soreness on 13Jan2021 in left arm at injection area after receiving the second dose. Her headache was not very strong. It was mild headache since she took Tylenol. She clarified it recovered completely as of yesterday (14Jan2021). When querying seriousness, she states it was a normal side effect so she did not think it is serious. She reported her body felt uncomfortable, and she cannot explain what it was happening, she did not have shortness of breath or diarrhea or anything. States it was like she got flu vaccine and had pain at injection site for a little bit. She received the flu vaccine in Nov (no year reported) and she does not know the name of the flu vaccine. The patient recovered from headache and muscle soreness/muscle soreness in left arm at injection area after receiving the second dose on 14Jan2021. Outcome of the rest of the events was unknown.
54 2021-01-28 feeling hot About 15 minutes after vaccination she reported feeling light headed and nauseous like the start of ... Read more
About 15 minutes after vaccination she reported feeling light headed and nauseous like the start of a panic attack. She tried to walk outside for fresh air, but had to sit down after about 20 feet of walking. She reported more nausea, feeling very hot, and had a hard time communicating. She was given a cool washcloth and fanned while being held up by a support person. Her blood pressure was initially high, and rose significantly over a period of about 5 minutes. Blood sugar was checked and was 475 mg/dL. 911 was called, and after about 10 minutes of supportive care paramedics transported her to the hospital. She was fairly limp at time of transport and had a hard time standing. The facility staff updated me several hours later that they had heard that she was doing well. It appeared to be a panic attack.
54 2021-01-28 feeling hot Whole body hot, then general malaise, cephalgia and insomnia.
54 2021-01-28 flushing Patient felt anxious, flushed, and itchy. She reports hives over her chest and feeling lightheaded,... Read more
Patient felt anxious, flushed, and itchy. She reports hives over her chest and feeling lightheaded, though this was likely secondary to anxiety. Denies any other symptoms, SOB, throat swelling, abdominal pain, or nausea.
54 2021-01-28 pain in extremity pt states she has sore left arm around the injection site and looks like she had two injection marks... Read more
pt states she has sore left arm around the injection site and looks like she had two injection marks. Pt states she has had headaches and pain in the clavicle area with swelling in her lymph nodes on the left side.
54 2021-01-28 pain in extremity After I received my first dose around 8PM the pain in my right arm started. I could not move my arm,... Read more
After I received my first dose around 8PM the pain in my right arm started. I could not move my arm, the pain was unbearable, like someone had hit me several times with a baseball bat or something similar. I couldn't sleep due to the pain. It lasted for about 2 days. No other symptoms other than the awful excruciating pain.
54 2021-01-29 tingling, flushing 20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing... Read more
20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing. Did not progress, waxed and waned. Had more flushing later, took benedryl. Went to Urgent care, advised benedryl to continue, but did not feel there was any cause for concern. Day after injection, mild flushing at times, and diffuse mild itching including scalp, face, particularly borders, and general arms, legs, torso. No rash, hives, and itching not aggressive, just mild. Persisted for about a week. Feel anxiety may have played role. Continued with benedryl. Had telehealth visits with PCP and with allergist. Resumed taking zyrtec daily with additional dose in pm- symptoms resolved. Not felt to be "serious" reaction by either MD, feel it is ok to have 2nd dose.
54 2021-01-30 migraine Severe headache (migraine) lasting 16 hours, nausea and vomiting, fever 101 for 6 hours, severe fati... Read more
Severe headache (migraine) lasting 16 hours, nausea and vomiting, fever 101 for 6 hours, severe fatigue, body aches, injection pain hot and very sore and hard.
54 2021-01-31 feeling cold Same symptoms as after 1st vaccine. starting about 12 hours post injection I developed chills, feve... Read more
Same symptoms as after 1st vaccine. starting about 12 hours post injection I developed chills, fever, could not get warm, joint pain-specifically low back, hips, shoulders, achy all over, headache, nausea. Slept poorly. Woke up the next morning with headache, achy. All symptoms passed about 18 hours post vaccine. of note I have never been tested for covid but my husband had a severe case in March. I tested positive for antibodies twice with the most recent time 12/14/20. I have never had symptoms of covid (until I got the vaccine)
54 2021-01-31 muscle spasms, weakness, numbness, tingling Dizziness and weakness; Numbness and tingling; Other ADVERSE REACTION Reported: Electrolyte imbalanc... Read more
Dizziness and weakness; Numbness and tingling; Other ADVERSE REACTION Reported: Electrolyte imbalance requiring hospitalization for More than 48 hours with repeated hematology follow up. Patient is a 54-year-old woman with history of Roux-en-Y gastric bypass surgery and some alcohol abuse who presented to the hospital with fatigue, headache, muscle cramps and weakness. She also had a slight fever that followed her 2nd dose of COVID-19 vaccine. She had basic lab work which revealed pancytopenia along with multiple electrolyte disturbances including hypokalemia, hypomagnesemia, hypocalcemia and hyponatremia. She admits that she had heavy alcohol use over the weekend with binge drinking of liquor. She otherwise does drink a couple of mixed drinks a night. She has also been trying to lose a lot of weight. She says that she lost about 60 lb in the last 6 months on purpose. She is doing this so that she can have a panniculectomy and tummy tuck. She recently had a breast reduction in November. She has not been following with a dietitian or having her vitamin levels checked. Despite having pancytopenia, her levels remained pretty stable during her stay. She had a peripheral smear sent which was pending at the time of discharge. She was also checked for vitamin deficiencies. She is given a dose of IM B12, IV iron, IV calcium and started on oral calcium vitamin-D supplements. She does take a daily multivitamin. Due to her reported history of heavy alcohol use she is also given thiamine and folate. After speaking with Hematology, recommendations were for her to have a follow-up appointment which is scheduled on February 10th. I also put in a referral for a dietitian to evaluate her for further recommend deficiencies in the setting of Roux-en-Y gastric bypass surgery with heavy weight loss. I prescribed her calcium vitamin-D along with folic acid. I recommended she continue her multivitamin. I also recommended that she abstain from alcohol use.
54 2021-01-31 nerve pain Feel tired, chill, mild fever(100.9F), Whole body ache(muscle, bone, nerve pain) with headache, Sens... Read more
Feel tired, chill, mild fever(100.9F), Whole body ache(muscle, bone, nerve pain) with headache, Sense of smell and taste lower down, tonsil swelling, Lymph node swelling and pain.
54 2021-01-31 pain in extremity fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath. She ha... Read more
fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath. She had an eppy-pin she used.
54 2021-01-31 pain in extremity body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; ... Read more
body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; a little swelling; throat dry at night; joint pain/ankle pain; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 08Jan2021 14:00 at a single dose for COVID-19 immunization. The patient medical history was none. Patient's concomitant medications were not reported. The patient previously took cortisone. It was reported that the patient got the vaccine on 08Jan2021 and started having the headaches right after. Still has some pain in the forehead and temples area. Has had neck pain, overall body aches, joint pain, pain in ankles and legs that still happens with getting up and down from sitting position. Overall pain is improved but still there, still has pain in ankles and legs. Got the shot in the left upper arm and having real bad armpit pain and a little swelling there. It has gotten a little better, but mostly hurts when moving and laying down. Has had a cough since she got the vaccine, it's mostly a dry cough and not really wet and mostly in the morning. She drinks a lot of fluids throughout the day and still has a little cough off and on. During the night her throat is really dry and which causes more coughing which she did not have before the vaccine. They are mostly concerned with the cough and the stuff when read online about the side effects that last about 2-3 days, but these have been since she got the vaccine. They know this is also know and not much known about it or what is normal yet, but they want to know if she could get the second vaccine, would it be okay. It was stated that the seriousness of the events is in the middle of not serious and medically significant. She is worried about the cough since it is ongoing, when reads online the side effects are listed as 2 or 3 days and her side effects have been going on since she got the vaccine which is worrisome. The outcome of the events cough and throat dry was not recovered, event pain was recovering, while the outcome of the rest of the events was unknown. Information on the Lot/batch number has been requested.
54 2021-01-31 pain in extremity I had my first covid vaccine 12/22/20. On 12/24/20 I noticed I could not see as well as normal with... Read more
I had my first covid vaccine 12/22/20. On 12/24/20 I noticed I could not see as well as normal with my RIGHT eye. I had a sore left arm and headache, which I attributed to the vaccine. By 12/27/20, I called the emergency number at my primary ophthalmologist as was seen. They thought I had a posterior vitreous detachment and asked me to see my primary eye doctor in a week. By 12/30/20 I could not see to work and called the eye doctor and they decided I should see my retinal specialist who deals with problems with my left eye. He could see nothing to explain my decreased acuity and told me to keep my follow up at the other office. I saw a Dr on 1/4/21, who takes care of my left eye cataract and glaucoma. He called in an associate. My vision had further declined and they thought I had ocular neuritis. I couldn't see the big E on the eye chart at all at my worst. I was scheduled for an MRI of the head, which showed ocular neuritis in my right eye. Dr assumed care and I started IV steroids on 1/13 for 3 days, followed by oral prednisone taper. I also was referred to a neurologist to rule out MS. I saw Dr. 1/28/21. After the steroids, my vision improved, but I still can't work or drive. Neurologist does not think I have MS and is ruling out NMO but doesn't think I have that either.
54 2021-02-01 weakness, pain in extremity kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Hea... Read more
kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Headache; Chills; Left arm hurting really bad; A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Jan2021 07:15 at single dose in left arm for covid-19 immunisation. Medical history included menopause from May2020 and ongoing (She is going through menopause, which started 7 months ago). There were no concomitant medications. Received call from consumer regarding the Pfizer BioNtech COVID vaccine. She had first vaccine yesterday morning and is experiencing some side effects. It looks like it was prescribed by a pharmacist, but she is not able to see the name and does not have any contact details to provide. She signed up at the online thing for reporting. Her arm is much better this morning. She woke up at 03:00 with the headache and still has it. Dizziness and weakness started 06:30 this morning. She kind of fainted. She was walking from one room to the next and she just gave out. It has improved and she is not really dizzy any more. She is having a little fatigue though. Chills began at 06:30 and they come and go. She is going through menopause and it could have something to do with it. She was unable to answer outcome for this. She just wants the headache to stop. She has not been able to do anything today. She is going through menopause, which started 7 months ago. She would like to know if there is something she can take for the headache. AE Details and time of onset: Left arm hurting really bad 18:00. When she first got it, she did not feel it. As the day progressed, she could feel the pain. Headache 03:00. Dizziness and weakness 06:30. Fatigue 06:30. Chills 07:00-07:30. She layed down at that point. Body feels tender and skin feels tender to touch 09:00. NO ER or physician's office required. No prior Vaccinations (within 4 weeks). The outcome of the event dizziness was resolved, Chills was unknown, Headache was not resolved, while the outcome of the other events was resolving. Information on the lot/batch number has been requested.
54 2021-02-01 numbness, tingling tingling and numbness in right arm itching and rash around left wrist
54 2021-02-01 tingling This is a spontaneous report from a contactable other hcp (patient). A 54-year-old female patient r... Read more
This is a spontaneous report from a contactable other hcp (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via unspecified route of administration on 19Jan2021 14:00 at a single dose on left arm for covid-19 immunization. There was no medical history reported. Patient has no known allergies. Concomitant medication included Atenolol 25 mg, vitamin C 1000mg, vitamin D 5000mg; all on unspecified dates for unspecified indications. On 19Jan2021 at 14:15, the patient stated that "after the injection I went to the waiting area. I started to feel tingling on my left side of my face and then my nose and a little on the right cheek. I got the injection at 2 pm and now is 8:28 and I still have the tingling." Patient has not received any treatment. There were no other vaccine administered in four weeks. Patient has no COVID prior vaccination and has not tested post vaccination. The outcome of the event was not recovered. Information on the Batch/Lot number has been requested.
54 2021-02-02 feeling of body temperature change Ten minutes after injection felt lightheaded/dizzy with brief periods of feeling alternately "hot an... Read more
Ten minutes after injection felt lightheaded/dizzy with brief periods of feeling alternately "hot and cold". Then felt some chest tightness with some difficulty breathing but no wheezing, She felt the tightness sensation on her chest. EpiPen administered once with transient improvement of symptoms but then recurred then administered EpiPen again. Thinks she saw some hives on her chest. Taken by ambulance and administered diphenhydramine 50mg Taken to the ER with no rash, upper/lower respiratory symptoms noted. EKG and cardiac workup negative. Patient discharged after 4 hours after improvement of symptoms with no other treatment given. Serum tryptase sent and 6.4mcg/mL.
54 2021-02-02 flushing Employee received Pfizer Covid19 vaccine on 2/3/2021 at 8:30 am and at 12:30 pm she began having in... Read more
Employee received Pfizer Covid19 vaccine on 2/3/2021 at 8:30 am and at 12:30 pm she began having intermittent palpitations and "flushed" feeling in her chest.
54 2021-02-02 numbness swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrre... Read more
swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
54 2021-02-02 muscle spasms, feeling cold On 1/28/2021, I woke from my sleep with legs cramps and muscle pain. I went to the toliet to urinat... Read more
On 1/28/2021, I woke from my sleep with legs cramps and muscle pain. I went to the toliet to urinate and began to have multiple bowel movement. I began to feel nauseated and very cold with shortness of breath and my heart racing. I cleaned up, washed my hands and proceeded to check my temperature it read 91.5, I continue to check it and it continue to read 91.5. I drank water and orange juice thinking it was my blood sugar. I began to feel dizzy but did not want to lay flat on my bed due to the shortness of breath. My heart rate was 120. I checked my blood pressure it was 180/120. I was fearful of shock. I continued to pace and warm up with blankets and a space heater. I took a warm bath and my temperature increased to 97.7. I continued to feel my pulse racing. I called Dr. office and got an appointment to see her 8:30 am 1/29/2021. She checked my vitals signs B/P - 143/87, P 80, T 98.1 O2Sat 99, heart and lungs. She did labs and urinalysis. She prescribed Clonidine 0.1mg TID take if BP greater 160/90 and Allergra 180 mg QD prn for itch and reaction. I will return to see her 2/5/2021.
54 2021-02-03 difficulty speaking, tingling 10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after i... Read more
10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after injection splotchy redness both legs. Approximately 2 hours after injection tingling around neck, tingling in lips and swelling and tingling right side of face and voice change hoarseness.
54 2021-02-03 numbness, tingling Right sided facial numbness and tingling started 4 days post vaccination. Treatment: OTC Zyrtec with... Read more
Right sided facial numbness and tingling started 4 days post vaccination. Treatment: OTC Zyrtec with mild improvement Outcome: Does not interfere with ADLs.
54 2021-02-03 pain in extremity approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals: ... Read more
approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals: 112/78, HR 69, 16 RR,A/0x3, As time progressed c/o achiness when she turns head side to side. 7:12pm c/o head felt foggy, improved chest tightness, heaviness in abdomen, achiness in R) arm pitdenies SOB, BP:110/78, Hr 66, 7:25: felt HR flutter occasionally, heaviness in legs increased and cont. light headed. but ROM WNL, Denies numbness/tingling, denies SOB, no swallowing problems during entire time. Couldn't go back to work and went home with nursing instructions if heaviness were to increase or other symptoms worsen to call 911 or go to ER. Taken home by mother and brother. called next day and symptoms improved.
54 2021-02-03 tingling, numbness 1) Immediately noticed that I was light-headed or dizzy upon receiving shot. 2) My face started to ... Read more
1) Immediately noticed that I was light-headed or dizzy upon receiving shot. 2) My face started to feel numb on the left side (below the eye to the jawline and from below my left ear to my nose area. I was worried about a stroke, so I made sure that I was able to smile in my rear-view mirror. The numbness began to clear up around 8 hours later without any muscular drooping of eye or mouth. I still have tingling or a numb feeling in areas but it is not significant at this time. 3) fatigue, slight nausea, pain in right collar bone area has been present since Monday. All seem to be minor side effects.
54 2021-02-03 tingling Tingling in the face occurred after both doses of the shot. I didn't know it was an adverse effect a... Read more
Tingling in the face occurred after both doses of the shot. I didn't know it was an adverse effect after the first dose, but my daughter is in medical school and told me that it could be and I should report it
54 2021-02-04 feeling hot Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orall... Read more
Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orally administered with water, pt went by ambulance to the hospital
54 2021-02-04 numbness bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tight... Read more
bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer. She asked if shellfish is in the vaccine. Information about lot/batch number has been requested.
54 2021-02-04 numbness Numbness on the right side of my face after having spent 35 minutes after having the vaccine, the du... Read more
Numbness on the right side of my face after having spent 35 minutes after having the vaccine, the duration was 45 minutes after this time it was waking up little by little.
54 2021-02-04 migraine, pain in extremity Patient reports with 1st shot had arm pain described as mild and not interfering with daily activiti... Read more
Patient reports with 1st shot had arm pain described as mild and not interfering with daily activities. Patient reports with second shot, within 5 hours had arm pain, malaise, headache, and nausea. At 7 hours symptoms increased in severity limiting activity. Also had chills and body aches. Unable to sleep overnight, felt feverish. On day 2 had difficulty working due to migraine headache, unrelieved by migraine medication. On day 3 migraine remained present but was less severe, modifications needed to continue working. On day 4 had worse migraine and nausea, unable to work. Developed itchy blisters, at least 12 to inner thighs, also on belly and back. Took OTC allergy medication, no worsening or additional spread of blisters following this.
54 2021-02-04 pain in extremity HEADACHE, TEMPERATURE 101.4, DEEP MUSCLE ACHES, FATIGUE. AFTER DAY TWO AFTER INJECTION I STILL HAD A... Read more
HEADACHE, TEMPERATURE 101.4, DEEP MUSCLE ACHES, FATIGUE. AFTER DAY TWO AFTER INJECTION I STILL HAD A HEADACHE THAT I COULD'NT GET RELEIF FROM WITHOUT MIGRAINE MEDICATION. DAY 3 I HAD A VERY SORE AND SWOLLEN ARM BUT OTHER SYMPTOMS SUBSIDED. DAY 4 A LITTLE FATIGUE BUT FEELING GOOD.
54 2021-02-04 pain in extremity she was useless; diarrhea; vomiting; low grade fever; sore arm; Stomach cramps; didn't feel good; Th... Read more
she was useless; diarrhea; vomiting; low grade fever; sore arm; Stomach cramps; didn't feel good; This is a spontaneous report from a contactable consumer (patient). The 54-years-old female patient (weight: 150lb-160lb) received first dose of bnt162b2 (BNT162B2, lot number: EL0142), via an unspecified route of administration in left arm on 14Jan2021 15:40 at SINGLE DOSE for covid-19 immunisation. Medical history included none. No Prior Vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID), omeprazole, calcium. On 20Jan2021 weds: "bad diarrhea", vomiting, low grade fever, sore arm (only the day after) and bad stomach cramps. Caller says, "if that's going to happen after 2nd dose- I wont take it". Caller referred to HCP for treatment of post vaccination side effects. She notes that at work on Wednesday she didn't feel good on 20Jan2021 and yesterday she was useless on 21Jan2021. She does feel better today thank goodness. No AE(s) require a visit to Emergency Room or Physician Office. The outcome of the events didn't feel good, she was useless, sore arm was unknown and was recovering for the rest events. No follow-up attempts possible. No further information expected.
54 2021-02-04 throat numbness PATIENT INITIALLY COMPLAINED OF DRY MOUTH, METALLIC TASTE WHICH PROGRESSED TO NUMBNESS AND TINGLING ... Read more
PATIENT INITIALLY COMPLAINED OF DRY MOUTH, METALLIC TASTE WHICH PROGRESSED TO NUMBNESS AND TINGLING IN MOUTH AND THROAT. PATIENT BEGAN TO FEEL DIZZY AND WAS PLACED INTO TRENDLENBERG POSITION FOR 20 MINUTES, AFTER WHICH SHE RETRUNED TO HIGH FOWLERS POSITION. SHE CONTINUED TO COMPLAIN OF NUMBNESS AND TINGLING IN MOUTH AND THROAT AND PATIENT REQUESTED EMS BE CALLED. PATIENT WAS NEVER IN ANY APPARENT RESPIRATORY DISTRESS, HR STRONG AND REGULAR, INITAL BLOOD PRESSURE MILDLY ELEVATED, SUBSEQUENT ONES WERE WNL.
54 2021-02-05 facial pain Woke up approximately around 1:30 a.m. with chills. Got up to get ready for work and felt slightly a... Read more
Woke up approximately around 1:30 a.m. with chills. Got up to get ready for work and felt slightly achy so I took my temp and it read 100.6. I ate a piece of toast and took one 500 mg tablet of a Tylenol and went to work but was sent home due to the fever after getting home my aches kept getting worse I developed a headache and my temp fluctuated all day between 99 3 and got as high as 101.7 bye the afternoon. When I went to bed around 10 p.m. my temp had dropped to 99 but my upper lip felt puffy and was slightly swollen. When I got up the next morning at approximately 6 a.m. my upper lip was still swollen and my right cheekbone very was very tender to the touch. Upon submitting this report it is approximately 1:15 Eastern Standard Time and my lips are mostly back to normal but around my mouth is very tender and to my right cheek bone is still very tender to the touch. Other than that headaches are gone fever is gone and I overall feel pretty good.
54 2021-02-06 feeling of body temperature change I felt lightheaded immediately after receiving vaccine on 2/01/2021 but it went away after 30 minute... Read more
I felt lightheaded immediately after receiving vaccine on 2/01/2021 but it went away after 30 minutes. On 2/07/2021 I started feeling tired with alternating cold/hot spells. After an hour I took my temperature and it was 99.5. I took 2 Tylenol and am waiting for relief.
54 2021-02-06 numbness Numbness of lips, mouth, chin, upper area of neck
54 2021-02-07 numbness, throat numbness numbness to right side of face from cheek to jaw line, to right side of lips, and also to the insid... Read more
numbness to right side of face from cheek to jaw line, to right side of lips, and also to the inside of the mouth on right side and inside right side of throat.
54 2021-02-07 tingling, numbness next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE... Read more
next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE numbness and tingling. Went to ED given hx of CVA. Testing all normal. Started to resolve 2 hours later. Continues to have pain at injection site (today is 2/8/2021)
54 2021-02-07 tingling, muscle spasms, numbness both of her legs seized. The muscles so tight that I was unable to walk (like a spasm); The muscles ... Read more
both of her legs seized. The muscles so tight that I was unable to walk (like a spasm); The muscles so tight that I was unable to walk/ just a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body); like a spasm; bilateral jaw pain; slight numbness on by left face; face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw; redness on my left cheek; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 21Jan2021 09:15 at a single dose for COVID-19 immunization. Medical history included shellfish allergy. Concomitant medications included received within 2 weeks of vaccination but were not reported. The patient previously took codeine and experienced allergy. On 21Jan2021 11:30, both of her legs seized. The muscles so tight that she was unable to walk (like a spasm). There was no twitch just a muscular contraction that left her unable to walk properly (the left side seem to be the tightest side of by body). The patient also had bilateral jaw pain (not sure if it was because she was in so much pain in the legs that she was clenching my teeth). She also had slight numbness on by left face and by the evening she had redness on her left cheek but it went away. Her face still had a bit of muscle sensitivity (tingling sensation) near the mouth and jaw. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Events were reported as non-serious. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
54 2021-02-07 tension headache Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep... Read more
Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep and mind was racing; her mind was racing; Soreness at the injection site; Tension headache with pressure; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on left arm on 20Jan2021 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient received the vaccine on Wednesday, 20Jan2021. This was her first dose. She had the vaccine at 12:30 PM. Right after the vaccine she waited her 15-20 minutes and was fine. These things did not start till later. She was not sick prior to getting the vaccine. 8 hours after, around 8:30 PM she had a tension headache with pressure that went all through the night and let up around 21Jan2021 10 AM. Around 12 AM Thursday morning on 21Jan2021, she had chills, fever, and a racing heart. She ached from head to toe/body soreness. It was a flu like feeling. Then they all got better around the same time 21Jan2021 evening. The racing heart was not enough to need 911. It worried her but was not enough. She also could not sleep and her mind was racing. She thinks it was because what was going on with her racing heart. It was making her head pound. She finally was able to sleep last night on 21Jan2021 around 8:30 PM and slept until 4:30 AM this morning on 22Jan2021. The doctors said if she was not better by tomorrow they would work her in to see her. But she is much better today. She also had soreness at the injection site on 20Jan2021. She knew that was normal though. She is still sore but overall is better. It felt like there was an invasion in her body. She is a little scared now for the second dose. She is unsure if she wants to get it. She asks, do you recommend getting the second dose after she had all of these side effects? It worries her. The heart is the main thing. That worried her the most. Outcome of the event tension headache with pressure, chills, fever, heart racing, ached from head to toe/body soreness, flu like feeling was recovered on 21Jan2021, outcome of the event could not sleep and mind was racing was recovered on 22Jan2021, outcome of the event soreness at the injection site was not recovered.
54 2021-02-08 pain in extremity Extremely sore arm, chills with no fever, general body aches and tiredness that lasted 2 hours.
54 2021-02-09 numbness Adverse effect: numbness on the right side of body, facial numbness, oral mycosis numbness Treatmen... Read more
Adverse effect: numbness on the right side of body, facial numbness, oral mycosis numbness Treatment: Benadryl Outcome: Recovered in 2 hours
54 2021-02-09 pain in extremity, breast pain Very sore right arm; Very sore right arm, right underarm; right breast pain; Tender lymph nodes unde... Read more
Very sore right arm; Very sore right arm, right underarm; right breast pain; Tender lymph nodes under the right arm, and the right side of the neck; Tender lymph nodes under the right arm, and the right side of the neck; tender right breast; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3248) via an unspecified route of administration in right arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included HTN (hypertension) hereditary. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HCTZ), verapamil hydrochloride (VERAPAMIL). The patient previously received the first dose of bnt162b2 (Lot number: EK5730) on 22Dec2020 11:00 in right arm for COVID-19 immunization. Events started from 12Jan2021 18:00 included very sore right arm, right underarm, and right breast pain onset the evening of the second dose, tender lymph nodes under the right arm, and the right side of the neck, also, tender right breast. All symptoms still present 13 days later, but better. The adverse event result in Doctor or other healthcare professional office/clinic visit. This is a non-serious report per reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
54 2021-02-09 pain in extremity achy for 3 days, stuffy headache, sore throat on and off, sore upper arm for 4 days I'm taking Ibup... Read more
achy for 3 days, stuffy headache, sore throat on and off, sore upper arm for 4 days I'm taking Ibuprofen.
54 2021-02-09 tremor Woke up with uncontrollable shaking in teeth chattering, lasted a couple of hours until I fell aslee... Read more
Woke up with uncontrollable shaking in teeth chattering, lasted a couple of hours until I fell asleep. Terrible headache, body ache & fatigue all day. The next day I had a headache and fatigue.
54 2021-02-11 flushing 15 minutes after receiving vaccine, felt flushed, about an hour later felt short of breathe and ches... Read more
15 minutes after receiving vaccine, felt flushed, about an hour later felt short of breathe and chest tightness
54 2021-02-12 discomfort COVID PSYSR Vaccine observation area 1622 - 20 min after injection c/o itching inside of left ear ... Read more
COVID PSYSR Vaccine observation area 1622 - 20 min after injection c/o itching inside of left ear / left face and left eye VS 150/102 HR 79 O2sat 97% Doctor notified 1628 sx increasing - Benadryl 25mg PO given 1640 sx decreasing VS 157/91 HR 65 1650 face and ear itching resolved.... eye still feel heavy 1700 - feeling well. Left observation area
54 2021-02-12 flushing Th 11 Feb: initially flushed face within 15 min of shot; chest pressure and shortness of breath with... Read more
Th 11 Feb: initially flushed face within 15 min of shot; chest pressure and shortness of breath within 30 min-1 hr; took benedryl 3 hrs later before bed but woke up next morning (12 Feb) with similar symptoms; symptoms are continuing into 13 Feb with added swollen lip - tool L-lysine and 5mg levozyterizine antihistimine;
54 2021-02-12 pain in extremity Cellulitic Sweet's syndrome of lower extremity. Significant LLE erythema and pain out of proportion ... Read more
Cellulitic Sweet's syndrome of lower extremity. Significant LLE erythema and pain out of proportion to exam that has continued to progress despite broad-spectrum antibiotics, now s/p OR cut down x3 with no e/o necrotizing fasciitis. Initially most c/f infection/cellulitis, however in discussion with ID, rheum, and derm and given progression of rash in s/o broad spectrum Abx and negative tissue cultures, now most suspicious for cellulitic variant of Sweet's syndrome (SS). Pathology report w/neutrohpliic inflammation w/evidence of ischemia, w/o evidence of infection, c/w Sweets Syndrome. While this is a rare disorder, it primarily occurs in the setting of recent infection or malignancy. Currently working up potentially triggers. Infectious work up thus far negative. Hematologic malignancy most often linked with SS, given new and worsening pancytopenia, will consult heme for recommendations for additional work up. Other potential triggers include vaccinations (question about COVID vaccine recently) and often idiopathic. Maintain of treatment for SS is steroids, dermatology currently managing dosing.
54 2021-02-13 weakness I got the second does of the Pfizer. I had a massive headache and chills overnight. I had a fever of... Read more
I got the second does of the Pfizer. I had a massive headache and chills overnight. I had a fever of 100.1 at 7.10am the next morning. I was leaving my ground floor bathroom and I woke up on my basement floor. I fainted and fell down a flight of stairs. I passed out again, when I tried to get back up the stairs. I crawled back up the stairs and phoned my husband to come home, He did and helped me into the bathroom to wash my teeth. I fainted again and he caught me and carried me back into the sofa. I spent the rest of the day in bed. I am bruised and scraped all over. I am sore all over. I went to Urgent Care on 2/13/21 and got x-rays done. I have a fracture in my right thumb and may have a dislocated left shoulder. I have to see more doctors tomorrow. I sill don't fell well and I have no appetite. I fell really weak. I have dizziness when lying down, that may be related to the fall.
54 2021-02-13 pain in extremity AFTER 1ST 10 MINUTES, PAIN IN UPPER RIGHT THIGH. LACK OF APPETITE, CONSTANT SLEEPING, CONSTANT SLEEP... Read more
AFTER 1ST 10 MINUTES, PAIN IN UPPER RIGHT THIGH. LACK OF APPETITE, CONSTANT SLEEPING, CONSTANT SLEEPING, AND EXCRUCIATING HEADACHE THROUGHOUT THE WEEKEND ALONG WITH NAUSEA AND GOING TO BATHROOM..HEADACHE INTO MONDAY NOT LETTING UP NO MATTER WHAT..SEVERE MUSCLE PAINS IN LEGS AS WELL
54 2021-02-14 burning sensation A pressure/low burning sensation down the lateral rear side of my left leg. I have not felt this pai... Read more
A pressure/low burning sensation down the lateral rear side of my left leg. I have not felt this pain sensation there so intensely since before my back operation in October 2018. The intense sensation lasted from Sunday 07 FEB through Tuesday 09 FEB 2021, when it started to slowly wane. The inoculation site also had minimal pain. Emailed my PCP and my orthopedic surgeon.
54 2021-02-14 flushing flushing, racing heart and light headedness lasting about 2 minutes 25 minutes after the shot and a... Read more
flushing, racing heart and light headedness lasting about 2 minutes 25 minutes after the shot and again 2 hours later.
54 2021-02-17 weakness Pt has continuous glucose monitor and she noticed the glucose reading was rising steadily. She took ... Read more
Pt has continuous glucose monitor and she noticed the glucose reading was rising steadily. She took extra injections of insulin, which would lower it slightly, but then it would go back up. Her glucose level got to 400 around 3:30 pm. She experienced issues with this for two weeks. She also had periods of abdominal pain, nausea, palpitations, and weakness.
54 2021-02-17 numbness This is a spontaneous report from a contactable other health professional (patient). A 54-year-old f... Read more
This is a spontaneous report from a contactable other health professional (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via intramuscular route of administration on 25Jan2021 at 14:30 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscular on 04Jan2021 at 11:30 am (age: 54-years) on the left arm for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 02Feb2021, the patient experienced numbness in arms, hands, legs and feet. The patient did not receive any treatment for the reported event. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was not recovered.
54 2021-02-17 pain in extremity Initial swelling on lymph node under the left axilla with pain and warm to touch on 2-5-21. Contact... Read more
Initial swelling on lymph node under the left axilla with pain and warm to touch on 2-5-21. Contacted MD who prescribed Augmentin 500 mg BID for 10 days. On day 13 after vaccine the swelling went away. Joint pain began on Feb 5th including hips, knees , ankles, wrist and elbows and continues to today. Rash began on both legs (thighs and calf) and hands. Raised rash non pustule red in color. This began approximatly 1 week post vaccine. Right hand began swelling on 2/16/21 with pain and redness. On 2/17/21 swelling increased and increased pain. Pain in right hand and wrist is worse on 2-18-21 (pain scale 6)
54 2021-02-18 breast pain, pain in extremity swollen left arm down though elbow area, swollen underarm area, swollen and pain left side of breast... Read more
swollen left arm down though elbow area, swollen underarm area, swollen and pain left side of breast up near under arm, could not lift left arm, painful down arm, up neck area, still having pain in arm. Pain is subsiding gradually daily, still noticeable.
54 2021-02-19 electric shock sensation, muscle spasms Subdural itching, electrical sensation 6 hours post injection, lasted 24 hours Tics and muscle spasm... Read more
Subdural itching, electrical sensation 6 hours post injection, lasted 24 hours Tics and muscle spasms, began 6 hours post injection, right side arm and side only, lasted 18 hours Severe headache, 4hours post injection, lasted three days Nausea, 12 hours post injection, lasted two days
54 2021-02-20 slow speech Dense brain fog- slow thought processing, difficulty concentrating, unable to multi-task, word findi... Read more
Dense brain fog- slow thought processing, difficulty concentrating, unable to multi-task, word finding difficulties, difficulty remebering what the next task is at work, difficulty problem solving, problem perfoming routine tasks in proper squence. Problem started 3.5 hours after injection and continue with minimal improvement 26 days later.
54 2021-02-21 cold sweat At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108... Read more
At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108/68, 97.6, RR 16, o2 98% on RA, and HR 45. Pt AOx4. Pulses thready. Patient?s skin is moist and clammy. Called for a WC and took pt to exam room where she sat in a reclining chair. VS taken every 5 minutes. She kept mentation through her stay. She states she felt slightly nauseated but was able to hold down water. VS started to improve once she was reclined in exam room. Education provided about f/u with PCP as HR fluctuated between 57-85. Educated about monitoring for symptoms the rest of the day and when to go in for evaluation is symptoms reappear. Pt verbalizes understanding. At 1400, pt states she is feeling better and feels well enough to leave facility. She has no one in town to come get her. VS= 02 98% HR 60, T97.8, BP 120/74, RR 16. Time of leaving, pulses were strong and equal, cap refill WNL. Will call at 1700 for F/U call.
54 2021-02-21 feeling hot, pain in extremity Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the he... Read more
Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the head. Within an hour, I felt exhausted. I went to sleep until about 7pm and when I woke up I felt really nauseous and still very tired. I had a little broth and went back to sleep. on 02/19/2021 at 1am I woke up feeling really hot and had horrible body aches. Even my joints hurt. I took my temperature and it was only 99.2 but my temperature usually runs 97.4 or 97.6. I woke up on 02/20/2021 and my left eye was crusted over just like the first vaccine. My body aches and nausea lasted until 02/20/2021. In the evening of 02/20/2021 I noticed about 10 little red bumps in various places on my body. (2 on left arm, one on back neck in hairline, two on upper back, one on chest, two on left leg, one on lower back and one on left buttock. Today is 02/22/2021 and I am still feeling fatigued. It's not as bad as it was over the weekend but I am still tired. My arm was much sorer with this injection.
54 2021-02-21 flushing Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one epi... Read more
Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one episode of emesis. Vital signs at 0830 were bp:184/108, p:112, SpO2:99%. At this time pt was flushed, skin was hot and dry. Vitals at 0835 were bp:179/124, p: 92. Pt began feeling chest pain. Vitals at 0840 were bp: 182-108, p:86. Emergency services were called and pt was transferred to local ED.
54 2021-02-21 numbness Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Mov... Read more
Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Moved to tip of nose; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number Em9809), via an unspecified route of administration at single dose in the left arm on 04Feb2021 11:30 for covid-19 immunisation. Medical history included pituitary tumour. The patient had not been tested for COVID-19 prior and post the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included famotidine, paracetamol (TYLENOL), cabergoline, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). On 04Feb2021 12:15, the patient experienced numbness in chin, then lip area. Moved to tip of nose and then several hours later, left eyelid and area between my eyes was completely numb. No treatment required. The outcome of the events was recovered.
54 2021-02-21 pain in extremity This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I s... Read more
This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I stayed for 45 minutes after my vaccine due to my blood pressure was high. I also felt a little fuzzy. About an hour later I got nauseous, had chills and felt very fatigued. The next morning when I woke up, my left eye was crusted over. I did not think anything of it until I got the second vaccine and it crusted over with it as well. I was very fatigued for 2 1/2 days. Arm was a little sore.
54 2021-02-22 mild one side paralysis, tingling Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with dimin... Read more
Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with diminish flow, tingling of the lips and tongue, pressure, tightness and pain in the chest. shortness of breath, right sided weakness and tingling of limbs and face. 50 ml of Benadryl, and 2 shots of epinephrine was given before transported to the Emergency Room via Ambulance On 2/22/2021 was sent to Urgent Care with the same symptoms. Urgent care sent me back to the Emergency room with heart arrythmias, chest tightness, tingling of lips and tongue.
54 2021-02-22 pain in extremity ill-effects started 16 hours after injection; sore arm; brief low-grade fever; vomited; intense mala... Read more
ill-effects started 16 hours after injection; sore arm; brief low-grade fever; vomited; intense malaise for 24 hours followed by 2.5 days of fatigue
54 2021-02-23 feeling cold ABOUT AN HR AFTER RECEIVING MY 2ND DOSE OF THE PFIZER VACCINE I FELT COLD AND A SLIGHT HEADACHE AND ... Read more
ABOUT AN HR AFTER RECEIVING MY 2ND DOSE OF THE PFIZER VACCINE I FELT COLD AND A SLIGHT HEADACHE AND FATIGUED. LATER THAT EVENING AROUND 7PM THE SYMPTOMS I EXPERIENCED GOT WORSE, POUNDING HEADACHE, AND CHILLS, AND EXTREME MUSCLE ACHE,. INSOMNIA AS WELL. 7AM THE NEXT MORNING CHILLS WERE LESS BUT STILL THERE, BUT THE HEADACHE PERSISTED AND THE NAUSEA GOT WORSE. STILL UNABLE TO SLEEP. AROUND 3PM HEADACHE SLIGHT AND MILD NAUSEA. NO CHILLS. TODAY 2/24/2021 STILL HAVE SLIGHT NAUSEA AND HEADACHE. BUT MUCH BETTER.
54 2021-02-23 flushing 0825 Feeling Shaky skin little red, Pfizer 2nd dose. 0835 Cheeks feeling flushed. Benadryl 50mg give... Read more
0825 Feeling Shaky skin little red, Pfizer 2nd dose. 0835 Cheeks feeling flushed. Benadryl 50mg given orally. 0842 Cheeks feeling better arms, still flushed NO SOB,NO CP NO NAUSEA 854am Reports no worsening symptoms 910 Feeling better released to go home.
54 2021-02-23 tension headache 2/23 headache, and today nausea with tension headache
54 2021-02-24 tingling 11:52 Nurse alerted by Client that she felt like her heart was racing. 11:53 Client taken for furthe... Read more
11:52 Nurse alerted by Client that she felt like her heart was racing. 11:53 Client taken for further assessment. Client also reports tingling in the fingers. Client was offered water which was taken and a seat by an open door for air. Client removed mask. Vitals taken: BP 185/100, Pulse 136. 11:59 Vitals taken: O Sat 99% Pulse 162. Client experiencing faintness and dizziness. EMT assessed Client further. 12:01 Client reports a slight tightness in her throat but reports the dizziness is lessening. Client reports no difficulty breathing. Vitals taken: O Sat 99% Pulse 142. 12:04 Vitals taken: BP 163/108, Pulse 128. 12:06 Vitals taken: O Sat 99%, Pulse 118. Client reports dizziness and tightness in the throat is lessening and feeling better. 12:08 Vitals taken: Pule 100, O Sat 98%. 12:11 Client reports no dizziness and the tightness in her throat is getting better. BP 157/99 Pulse 98. 12:15 Client reports that she feels well enough to leave. Client did decide to take a Benadryl due to a little tightness remaining. Client denied feeling any other previous issues or dizziness. Client given a 25mg (one tablet) of Benadryl. Education given regarding Benadryl taken. Client is here with her husband and daughter. Husband was present and Client felt well enough to leave. Client was able to ambulate to the car unassisted and her husband was able to drive her home
54 2021-02-25 discomfort, feeling cold, tingling After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressu... Read more
After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressure dropped significantly. They put me onto a gurney and monitored my BP and waited, gave me some juice and crackers, but I continued to have the sensation of fainting (syncope). They transferred me to the ER for further monitoring. After a while, it stabilized more, but still continued to happen throughout the day.
54 2021-02-25 flushing Headache, nausea, facial flushing, refused transport by EMS
54 2021-02-25 numbness, facial paralysis, tingling, bell's palsy Throat felt like it was closing and had difficulty swallowing (that subsided quickly) 45 minutes aft... Read more
Throat felt like it was closing and had difficulty swallowing (that subsided quickly) 45 minutes after the shot, the right side of my face felt numb and tingly (Felt like when novocaine is wearing off.) Continued for 48 hours and worsened with slight drooping when smiling. Clearing my throat a lot and my right eye keeps tearing up. The doctor confirmed it was "Bell's Palsy" this morning and I have been put on Prednisone.
54 2021-02-26 numbness Left side of face ear area fullness numbness progressed later to numb lip on left side and poor vis... Read more
Left side of face ear area fullness numbness progressed later to numb lip on left side and poor vision in left eye , chest pain in center of chest and walking imbalance
54 2021-02-28 breast pain pain above nipple, underarm lympnode is swollen
54 2021-02-28 feeling cold, feeling jittery Patient began to feel "jittery" and cold all over as soon as she received the shot. There was no int... Read more
Patient began to feel "jittery" and cold all over as soon as she received the shot. There was no intervention patient was observed for the full 15 min wait time and stated they felt fine and wanted to leave.
54 2021-02-28 feeling hot 0900: Rec'd Covid vaccine 0931: Pt c/o dizzy/light-headed, sweaty in car 0937: BP 116/78 HR 60 RR 16... Read more
0900: Rec'd Covid vaccine 0931: Pt c/o dizzy/light-headed, sweaty in car 0937: BP 116/78 HR 60 RR 16 SpO2 98% Drinking water/juice; opened car windows/door; lying down in car 0942: Left arm from neck down feels hot inside; less light-headed/dizzy & sweaty 0956: Still feeling lightheaded, resting in car w/HOB down
54 2021-02-28 numbness Within 5 minutes of vaccine I developed a tight cough. By 10 minutes I was wheezing, coughing and i... Read more
Within 5 minutes of vaccine I developed a tight cough. By 10 minutes I was wheezing, coughing and it was difficult to inhale deeply, was itchy with few hives, lips and tongue were tingling and I became dizzy. I was sent to the ER and received IV Benadryl, IV pepcis and an IV steroid along with an Albuterol breathing treatment. Heartrate 110-115 pulse ox 94% prior to meds and breathing treatment. BP not done. Symptoms resolved but by 1200 were all back. At that time I was given Epinepherine IM. Symptoms resolved by 1pm. Discharged from hospital by 4pm. By 5pm face numb and tingling from cheekbones to mandible. Resolved within 24hrs. Since then, I have had episodes of facial numbness and tingling, hives and overall itching, lip/tongue tingling and bronchoconstriction(not with exercise)
54 2021-02-28 pain in extremity Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigu... Read more
Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigue; minor nausea; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiration date unknown), via an unspecified route of administration on the right arm on 27Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included COVID-19; prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included Vitamin D NOS and Multi-Vitamin. The patient previously took injectable Iodine and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced soreness in arm - inability to lift above head, fatigue and minor nausea on 27Jan2021 at 13:00 (01:00 PM). No treatment was administered for the events. Since the vaccination, the patient has not been tested for COVID-19. The events were resolving.
54 2021-03-01 involuntary muscle movements I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very... Read more
I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very bad headache. I took and Advil. My husband was making breakfast. I came downstairs, ate, had a cup of coffee, then got a glass of water and an ice pack and sat on a recliner in the living room. I don't remember much of the rest. It was like a dream. My husband said I let out a yell, my arms flailed and my eyes were very strange. I lost muscle strength in my lift side mimicking a stroke. He called 911. I was taken to Emergency facility where I gained consciousness. I was then transferred to Hospital. So far every test has come back negative. I have an EEG scheduled for this Thursday.
54 2021-03-01 numbness, tingling Tingley feeling in the whole R arm, numbness to the ring and pinky fingers, Lasted for about 4 days
54 2021-03-01 pain in extremity Headache first symptom, sore right arm, high fever 102 for 24 hours, chills, dizzy , achy all over ,... Read more
Headache first symptom, sore right arm, high fever 102 for 24 hours, chills, dizzy , achy all over , very tired. after 24 hours symptoms dissipated. Then just tired and sore arm next day.
54 2021-03-01 pain in extremity Friday, Feb 26th 2021-About a hour after shot I had joint pain in my elbow and wrist. I took Tyleno... Read more
Friday, Feb 26th 2021-About a hour after shot I had joint pain in my elbow and wrist. I took Tylenol 1 hour prior to the shot and 6 hours afterwards. No redness or pain Friday evening. I had insomnia Friday night and did not fall to sleep until 5am. Saturday, Feb 27th, 2021- I woke up with joint pain to my elbow and wrist. Arm was extremely sore. I did not eat until 4pm and I took Tylenol then, Once I started moving my arm felt better and the joint pain went away. Trouble sleeping Saturday night. Fell asleep around 4am. Sunday, Feb 28th- Work up and arm wasn't as sore. Noticed around 1pm I had a red spot under the vaccine spot where I was injected. It was red and painful, about the size of 2 nickels put together. I took more Tylenol that evening and was ok. Monday, March 1st- I noticed the red spot had gotten bigger. It wasn't as itchy and was not bothering me. Around 8pm, I noticed the spot was bigger and itchy. I toke a Tylenol and Benadryl and about midnight put an ice pack on the redness for 15 min intervals. I did this 3 times. I outlined the red spot, which is now as big as a orange to see if it was spreading. Tuesday, March 2nd - Noticed no spread at 8:30am. Site beginning to itch. At 12 noon, taking a Benadryl and Tylenol after eating lunch.
54 2021-03-02 flushing light headed, Flushed.
54 2021-03-02 pain in extremity Sore arm, tired
54 2021-03-02 pain in extremity Sore arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-... Read more
Sore arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 15:15, at a single dose, for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication was not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 26Jan2021, at 04:00 AM, the patient experienced sore arm and body aches. The events were considered non-serious. The patient did not receive therapy for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination.
54 2021-03-02 tingling Pt states she recieved her first dose of the vaccine at 11:50 am.l Pt states after 40-50 minutes she... Read more
Pt states she recieved her first dose of the vaccine at 11:50 am.l Pt states after 40-50 minutes she started having tingling in her hands and face. Pt denies any rash, hives, or swelling. Crew determind the pt is having a panic attack and calmed her down. Pt's vitals are stable. Pt states she is feeling better and wants to leave. Pt didnt require transport to hospital.
54 2021-03-02 tremor Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells... Read more
Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells; motion; tired; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: T23248), intramuscular in the left arm on 29Jan2021 at 10:00 AM as a single dose for COVID-19 immunization. Medical history included known allergies to sulfa. The patient did not have COVID prior to vaccination, had no other vaccine in four weeks and was not pregnant at the time of vaccination. Concomitant medications included multivitamins, ibuprofen, and paracetamol (TYLENOL). The patient received the first dose of BNT162B2 on 10Jan2021. On 29Jan2021 at 07:00 PM, the patient experienced uncontrollable chills, stabbing pain all over, headaches, body shakes, nausea, sensitivity to smells, "motion", and tired. The patient was not COVID tested after vaccination. The patient received no treatment for the events. Outcome of the events was recovering.
54 2021-03-03 flushing lips numb, chest pressure, flushing, nausea. Evaluated by EMS-Cleared
54 2021-03-03 migraine terrible migraine at 9:00 next morning
54 2021-03-03 tingling, numbness The left side of my face and tongue got numb / tingly. It began to lessen after about an hour and co... Read more
The left side of my face and tongue got numb / tingly. It began to lessen after about an hour and continues to lessen as the day goes on. It is believed that my body may have just responded quickly. I was monitored for a few extra minutes, and then released.
54 2021-03-04 weakness, pain in extremity Nausea, weakness, fever, bad stomach pain, sore arm, dizziness
54 2021-03-04 bell's palsy No adverse reactions other then pain in the injection site and being tired then last night 48 hours ... Read more
No adverse reactions other then pain in the injection site and being tired then last night 48 hours later my eye was twitching. Today it 72 hours later eye twitching again and then this afternoon my bottom lip began to tingle. Called the Urgent care they said come in and I did and the said it is bells palsy and gave me steroids and another drug to take
54 2021-03-04 numbness She received vaccine at 3:20PM right deltoid. She felt numbness on the right side of her neck, ligh... Read more
She received vaccine at 3:20PM right deltoid. She felt numbness on the right side of her neck, lightheadedness, and sweaty profusely. She reports feeling foggy and dizzy . Vaccine center called Rapid Response Team.
54 2021-03-04 night sweats Fatigue, body aches, night sweats (like menopause), painful under armpits (even on second day), head... Read more
Fatigue, body aches, night sweats (like menopause), painful under armpits (even on second day), headaches
54 2021-03-04 pain in extremity, weakness Within a few hours of getting my first shot, I developed arthralgia and myalgia, including severe lo... Read more
Within a few hours of getting my first shot, I developed arthralgia and myalgia, including severe low back pain, right hip/groin pain), right ankle pain/weakness, mid/upper back pain, and severe fatigue. The low back pain, groin/hip pain, and fatigue lasted. 2.5 weeks. For those 2.5 weeks, I felt weak enough that I couldn't walk more than 30 minutes, when I had been walking 30-60+ minutes daily for the last year. Also, my low back/hip/groin felt "frozen," so it made it difficult for me to walk (I was limping). Within two hours of my second shot, I developed full-body arthralgia/myalgia, including thigh pain/weakness, low back/groin/hip pain, upper back pain, shoulder and neck pain, thumb and hand pain, and ankle weakness. Over the next 12 days, my right shoulder pain progressed to the point at which I had to get a cortisone injection in my right shoulder (for bursitis) today. Prior to the second Covid vaccine shot, I had not had shoulder bursitis symptoms since November 2020, when I had a cortisone injection. I am also still experiencing excessive fatigue from the second shot. I am reporting this information so it can be included in the post-marketing study.
54 2021-03-05 facial pain, numbness Within a few minutes after vaccination, while parked, she had onset of a severe pain on the right si... Read more
Within a few minutes after vaccination, while parked, she had onset of a severe pain on the right side of her face with numbness as if she just had dental work. She has history of severe migraines in past of similar severity, but usually on her head, not her face. The pain spread to her forehead. She denied weakness, shortness of breath, difficulty swallowing, face nor throat swelling. Her blood pressure was checked and was normal. Her face stayed symmetric. She had normal movement of all extremities. She took her migraine medication rizatriptan around 125pm. She repeated her dose 45min later. She was still in severe pain, but better enough where she could move and talk again. Her husband who was present, slowly helped her to the passenger seat and drove her home. I checked in 2 hours later and he reported that she was improving and resting. I advised multiple times to call us or 911 if having any new weakness. If she developed right face weakness, only we would likely start prednisone for bells palsy. Husband expressed understanding of plan. On 3/6 at 3pm, on follow-up call, pain has resolved. Still with numbness "as if I've been injected with novocaine", and tingling on her right side of face to touch. No weakness, no facial asymmetry.
54 2021-03-05 pain in extremity I received the shot Wed. afternoon. I had a sore arm right away, but that was all. Then Thur. I ate ... Read more
I received the shot Wed. afternoon. I had a sore arm right away, but that was all. Then Thur. I ate food that I normally eat (the doctor asked what foods I had) and went to bed. Fri 3am I work up and couldn't breath. I already have sinus issues, and it felt as if I was choking. I gargled, then looked at my throat in the mirror. My Uvula was swollen 3 times it's nomal size. I calle a family member to take me to the ER. I was diagnosed ith Uvulitis. givendiphenhydramine, dexamethasone, famotidine, and neck xray, and strep tests (which were negative) The doctor said it definitely was an allergic reaction. He asked me about foods (I hadn't eaten anything unusual) but couldn't conclusively say it was because of the vaccine.. None of the treatments worked, but they still released me, saying that it would eventually stop being swollen, and if it was still an issue in a week that I should contact my primary . Although my swelling came down after a day, my throat is still red and irritated as of Saturday.
54 2021-03-06 flushing, tingling Flushing, tingling of extremities, increased heart rate. Initial BP 135/79 (pulse 125). F/u BP 138/8... Read more
Flushing, tingling of extremities, increased heart rate. Initial BP 135/79 (pulse 125). F/u BP 138/83 (pulse 106), 98% O2 sat.
54 2021-03-06 muscle twitching -Twitching mostly in my legs and stomach and ribs especially during the first week. It substantiall... Read more
-Twitching mostly in my legs and stomach and ribs especially during the first week. It substantially subsided during the second week but still occasionally happens in my leg and sometimes in my temple area beside my left eye. -On the first or second day after vaccination, my pulse was beating profusely (fast and furious) between my left thumb and index finger mid-way toward my wrist of my right hand. I am not sure what that was, since I had never seen that happen before and it was not happening on my left hand. I am scheduled to take my second vaccine on 3/15/2021 so I am trying to find out if you would recommend that I take the second vaccine or not take it. I am scheduled to tak
54 2021-03-07 pain in extremity Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional. A... Read more
Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3246), via an unspecified route of administration on the right arm on 02Feb2021 08:15 at single dose for COVID-19 immunisation. Medical history allergies: pcn, latex, wheat/gluten, dairy, soy, corn. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (lot number: EL 3246) on 11Jan2021 06:30 PM on the right arm for covid-19 immunisation; epinephrine and experienced allergies. At 6:00 PM on 02Feb2021, patient developed fever 99.4 and steadily rose to 101.5 by 9:30 PM; sore arm all day and night, following day much less sore and easier to move. Fever stayed overnight, down to 100.5 morning on 03Feb2021. Nausea accompanied fever and still have slight nausea. The patient received no treatment. The outcome of the events was recovering.
54 2021-03-08 numbness, tingling Patient stated tingling and numbness. EMT transported the patient to hospital ER given Benadryl 50 m... Read more
Patient stated tingling and numbness. EMT transported the patient to hospital ER given Benadryl 50 mg.
54 2021-03-08 throat numbness Numbness of lips and throat commencing approximately one hour after receiving vaccine. Patient self-... Read more
Numbness of lips and throat commencing approximately one hour after receiving vaccine. Patient self-treated with benadryl and symptoms resolved after about 2 hours.
54 2021-03-09 numbness 15 minutes after receiving the vaccine, my tongue, lips, inside of mouth (roof) and cheeks became nu... Read more
15 minutes after receiving the vaccine, my tongue, lips, inside of mouth (roof) and cheeks became numb. I administered benadryl 30 minutes after receiving the vaccine. The symptoms came and went throughout the next 4 hours. I administered a second dose of benadryl 4 hours after the vaccine and that seemed to reduce the symptoms greatly. My temperature was slightly elevated during this 4 hour period, as well. I took tylenol and that was effective. I had no further symptoms overnight or today. My concerns were about whether or not I should get second vaccine.
54 2021-03-09 pain in extremity, flushing sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days l... Read more
sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days later; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included Known allergies to Possible latex, Diabetes, sleep apnea, PTSD (Post-traumatic stress disorder)/anxiety, herpes, vitamin d deficiency, environmental allergies, asthma. Concomitant medication was unspecified medication in two weeks. On 16Jan2021 08:00, The patient experienced sore arm, slept for 17 straight hours, chills, upset stomach, upper body flushing for up to 4 days later. Treatment received for the events included OTC medications. The patient was not pregnant. She had no COVID tested post vaccination. There was no other vaccine received in four weeks. The outcome of the events was recovered in 2021. information on the lot/batch number has been requested.
54 2021-03-09 pain in extremity Strong pain in the left arm decreasing the movement of the arm. Treatment of ice and Tylenol
54 2021-03-09 pain in extremity hives all over the body 2 days after the vaccine, severe forearm pain bilateral from elbow down and ... Read more
hives all over the body 2 days after the vaccine, severe forearm pain bilateral from elbow down and was unable to write or lift anything for 3-4 days . pain has improved but still has hives very itchy
54 2021-03-09 tingling Lightheaded, facial tingling, weird sensation in left hand. BPs 166/102 (pulse 84), 160/97 (pulse 77... Read more
Lightheaded, facial tingling, weird sensation in left hand. BPs 166/102 (pulse 84), 160/97 (pulse 77), O2 sats 100%.
54 2021-03-10 weakness Severe headache, arm soreness at injection site, vomiting in first 24 hours, nausea, fever up to 102... Read more
Severe headache, arm soreness at injection site, vomiting in first 24 hours, nausea, fever up to 102 but consistently at 100 for approximately 48 hours, weakness and fatigue. Headache lasted to third day but less severe.
54 2021-03-10 weakness Lightheadedness on 3/5/21 Soreness at vaccine site Shortness of Breath Body Chills Fatigue Weakness... Read more
Lightheadedness on 3/5/21 Soreness at vaccine site Shortness of Breath Body Chills Fatigue Weakness Headache
54 2021-03-10 facial paralysis, bell's palsy Bell's Palsy, right sided moderate facial paralysis, acute onset Started on prednisone 80mg x 7 day... Read more
Bell's Palsy, right sided moderate facial paralysis, acute onset Started on prednisone 80mg x 7 days, valacyclovir 1g TID x 7 days, and acupuncture
54 2021-03-10 night sweats, weakness Symptoms began about 12 hours after the 2nd shot. (The first one I just was lethargic for a couple o... Read more
Symptoms began about 12 hours after the 2nd shot. (The first one I just was lethargic for a couple of days and had a big knot at the injection site.). I had a terrible headache for about 36 hours and had zero energy for 2 days. I had night sweats the first night. Then I had a swollen, hot arm from left shoulder to elbow for 24 hours. It decreased some, but the knot remained for about 4 days. The symptoms were a lot less than the 2nd shingles shot I got in the fall. And certainly the symptoms were a lot better than the virus itself!
54 2021-03-10 tremor, slurring Approximately 8 minutes after vaccination, while seated in monitoring area, experienced sudden onset... Read more
Approximately 8 minutes after vaccination, while seated in monitoring area, experienced sudden onset of dizziness, profuse sweating, shakiness, difficulty speaking, stammering, difficulty sitting or standing without assistance, increased blood pressure, headache in right temple through back of head on right side. Nursing support response included taking me by wheel chair to isolated area, removing face covering, providing drinking water, monitoring pulse and blood oxygen rates and blood pressure. Began to feel better after several minutes, then symptoms returned but not as severe. Cycles of improvement and return of symptoms but diminished in severity occurred over the next 30 minutes. Tired feeling for approximately 4 hours following vaccine and low grade headache. Took 2 Tylenol regular strength approximately 1 hour following vaccine and again 4 hours later. 20 hours following vaccine, still feeling episodes of dizziness, headache, fatigue, difficulty with speech (stammering), shakiness, difficulty focusing/concentrating.
54 2021-03-11 discomfort, tremor First I had chills and quite violent shaking. I then got a fever and felt muscle aches, joint pain a... Read more
First I had chills and quite violent shaking. I then got a fever and felt muscle aches, joint pain and my skin hurt. I also had a headache on and off. Sleep was almost impossible due to being uncomfortable, and I had thoughts racing through my head. I also had lack of appetite, but not nausea.
54 2021-03-11 pain in extremity Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cou... Read more
Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cough, shortness of breath, traveling leg pain, development of ear infection, dizziness
54 2021-03-11 pain in extremity 3/8: Sore arm on day of first injection 3/9: Approximately 4 pm- Fever, chills, lethargic - 100 degr... Read more
3/8: Sore arm on day of first injection 3/9: Approximately 4 pm- Fever, chills, lethargic - 100 degree temperature day 2
54 2021-03-11 tingling, numbness Around 5:55 I felt a numbing at the top of my leg while seated while waiting my 15 minute wait time.... Read more
Around 5:55 I felt a numbing at the top of my leg while seated while waiting my 15 minute wait time. The numbing continued down the right side of my right leg. I didn't think much of it because I thought it was the way I was sitting. I didn't report it to anybody at that time. I got in my car and my three right toes started to numb. Then I felt it down my arm and the right three fingers. About 15 minutes later my jaw muscle, then up to my temple and across the fatty area of the eyebrow went numb. Several minutes later I noticed my nostril and right side of my tongue numb. It felt like my tongue and face were swollen but when looking in the mirror they were not and there was no drooping when I smiled and raised my eyebrows. It was a similar feeling that I have had when a shot has almost worn off from a dental procedure. The feeling and the movement is there but still tingly. The arm, leg, and toe numbness went away 2-3 hours later on the same day of the shot. I had no numbness on the left side. Two days later I still have the same numbness on my right two fingers, tongue, jaw, eyebrow area, and nostril.
54 2021-03-12 numbness patient sat down and started to feel numbness in the face swelling of throat and tightness in chest ... Read more
patient sat down and started to feel numbness in the face swelling of throat and tightness in chest patient was given an epipen and 911 was called she was taken to emergency room and monitored but currently feeling ok
54 2021-03-13 feeling hot, numbness, tingling pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose ... Read more
pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose approx 1:20, at 1:28 said her arm was going numb and declined water and food. 1:33 continued tingling numbness of left arm and jawline, she again declined food and water. 1:43 hot, sweaty, ache in chest and rapid pulse feeling. called ems, gave water and crackers, 1:48 bp between 103/80 Pulse 94 to 127/79 pulse 86. 1:55 bp 156/113 pulse 88. said her arm was tingly and face going numb, feeling her heart flutter. when EMS arrived she said her blood glucose was 286 this am and she took Humalog then. normal bp 130s/80s pulse in 90s. Tx to hospital, FU 3/12&3/14 said she had throat closing and vax site numb and swollen
54 2021-03-14 inability to speak, weakness Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, troubl... Read more
Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, trouble swallowing, difficulty breathing, confusion, chills, difficulty speaking.
54 2021-03-14 feeling cold, pain in extremity muscle pain, feeling cold, arm hurting
54 2021-03-14 nerve pain, burning sensation About 5-6 days after the vaccine, neuralgia around my rib cage mirroring that of shingles (which I h... Read more
About 5-6 days after the vaccine, neuralgia around my rib cage mirroring that of shingles (which I have previously had in the same place) became active. No rash or outbreak, but the neuralgia was present, with burning and pain for a couple days. It subsided, then returned a week later and has remained painful for 4 days.
54 2021-03-14 pain in extremity, nerve pain Severe pain in entire body including joints and muscles along with severe nerve pain which is a seve... Read more
Severe pain in entire body including joints and muscles along with severe nerve pain which is a severe burning pain in all extremities (arms and legs)and including low back, both hips, hands and fingers and ankles and feet. It started the same day of the vaccine and it has been 2 and a half weeks and it is still very severe and debilitating. Also with muscle fatigue. I had experienced severe lethargy until I was put on medication. My doctor first put me on prescription dose of Ibuprofen (2400mg over 24 hours) after a week and a half of being on Tylenol with no relief. After four days of Ibuprofen and it tearing up my stomach and having to go on medication for my stomach (Pepsid 40mg with Mylanta) I was still having severe unrelenting pain. My doctor then put me Prednisone 40mg taper. I am on day four of Prednisone and still having severe pain.
54 2021-03-14 pain in extremity Fever, severe chills and fatigue, headache, body aches, pain in left arm, full body hot rash. Began... Read more
Fever, severe chills and fatigue, headache, body aches, pain in left arm, full body hot rash. Began on the afternoon 3/14/21, became severe in the evening, into 3/15/21. Symptoms have improved, but are still present, I have been in bed for 24 hours.
54 2021-03-14 sensory loss, numbness Following vaccination, began experiencing numbness and difficulty of grip in the left hand's ring an... Read more
Following vaccination, began experiencing numbness and difficulty of grip in the left hand's ring and pinkie finger- difficulty to feel strong sensation
54 2021-03-15 weakness Soreness at injection site on the first day, around 24 hours later developed all over aches, lighthe... Read more
Soreness at injection site on the first day, around 24 hours later developed all over aches, lightheadedness, chills, and weakness to the point of not being able to ambulate. This lasted for two days, then started getting extremely swollen, sore lymph nodes under left arm to the point of not being able to tolerate wearing a bra along with dizziness and nausea. This has persisted for two days so far.
54 2021-03-15 pain in extremity Initially, my arm was sore and I had extreme nausea. That lasted for about 2 weeks. My doctor told m... Read more
Initially, my arm was sore and I had extreme nausea. That lasted for about 2 weeks. My doctor told me to take Prilosec.
54 2021-03-15 pain in extremity I got the shot about 1 pm, and everything went well. About 7 pm, my arm started to hurt, like every ... Read more
I got the shot about 1 pm, and everything went well. About 7 pm, my arm started to hurt, like every sore muscle. The pain grew, and my arm and shoulder hurt badly with any movement, so that when I used my arm, I cried out in pain. This morning the pain is there, and I wince with any movement, and if I forget and reach up, I cry out in pain. I know this is no big deal, but this was a very overt pain that I've not to experience in the past with shots I've received.
54 2021-03-15 pain in extremity Memory loss and difficulty concentrating, light vaginal bleeding, Shortness of breath and the chills... Read more
Memory loss and difficulty concentrating, light vaginal bleeding, Shortness of breath and the chills, Intense pain in both legs on the night, Insomnia 2 hours later after going to bed, Tiredness and sleepiness, Bruises on right leg.
54 2021-03-15 pain in extremity sore arm , joint pain and muscle more than normal and very sleepy.
54 2021-03-16 involuntary muscle movements On March 16, I was sitting in a chair next to my kitchen counter when I felt like my body was being ... Read more
On March 16, I was sitting in a chair next to my kitchen counter when I felt like my body was being thrown. My head was thrown forward and I hit the counter hard and sustained a large contusion above my left eye. The room was spinning and I was dizzy for the next few hours. I never lost consciousness but had no control of my body for the few seconds of the episode. The episode was sudden and violent and I was just sitting when it happened. I spoke with my physician who diagnosed me with having experienced a Tumarkin otolithic crisis. He has instructed me to wear a helmet and not to leave my home. He is also recommending that I have a labyrinthectomy to treat the symptoms. While I have a history of vertigo, I have not had any dizziness for more than a year. I now feel dizzy on and off most of the day.
54 2021-03-17 weakness Weakness, Body aches, headache, sinus issues
54 2021-03-17 difficulty speaking Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My li... Read more
Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My lips were tingling and my arms and legs felt suddenly so tired. They monitored me in the reaction tent for 45 minutes until I could sit up and walk. By the time I got home I had a burning rash on my neck and my voice was suddenly hoarse as if I was sick. Just rested and symptoms slowly subsided over the day. I must be hypersensitive to something because this is the third time I have had a reaction like this. The others were with the fly shot. Folks took good care of me.
54 2021-03-17 pain in extremity felt my left arm sour, heavy to lift; felt my left arm sour, heavy to lift; muscle ache on both shou... Read more
felt my left arm sour, heavy to lift; felt my left arm sour, heavy to lift; muscle ache on both shoulders; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247), via an unspecified route of administration on 17Feb2021 13:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of BNT162B2 on 27Jan2021 03:00 PM at left arm with lot number EL3247 for covid-19 immunization, also at age of 54 years old. Patient is not pregnant at the time of vaccination. The patient medical history was none, concomitant medications were not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Two hours after the 2nd dose, patient felt headache and fatigue. She took 500mg of Tylenol at 6 pm on 17Feb2021. The headache went away during the night. The next morning, she felt left arm sour, heavy to lift. Some level of muscle ache on both shoulders. Patient took another 500 mg of Tylenol. The arm sourness was much less in the afternoon on 18Feb2021, and totally disappeared on 19Feb2021. The outcome of event headache was recovered on 17Feb2021, events fatigue and "heavy to lift" were recovered in Feb2021, the other events were recovered on 19Feb2021. The events were reported as non-serious.
54 2021-03-17 tingling approx. 5-6 hours after vaccine: rapid/racing/fluttering heartbeat, entire left side tingle sensati... Read more
approx. 5-6 hours after vaccine: rapid/racing/fluttering heartbeat, entire left side tingle sensation- restless ness
54 2021-03-18 cold sweat PATIENT OBTAINED 'SHOT.' ABOUT 10 MINUTES LATER (SHE) BEGAN TO FEEL CLAMMY PT STATED THAT SHE MAY ... Read more
PATIENT OBTAINED 'SHOT.' ABOUT 10 MINUTES LATER (SHE) BEGAN TO FEEL CLAMMY PT STATED THAT SHE MAY HAVE 'BLACKED OUT' A LITTLE - PT HAS A HISTORY OF FAINTING IN EMOTIONAL SITUATIONS
54 2021-03-18 feeling hot Approximately 10 minutes after receiving the Pfizer BioNtech COVID-19 vaccine, pharmacist was alert... Read more
Approximately 10 minutes after receiving the Pfizer BioNtech COVID-19 vaccine, pharmacist was alerted by the vaccine ambassador that a patient was sitting on the ground likely having a reaction to the vaccine. The pharmacist came to the patient to assess the situation. Patient described that she was experiencing "a warm sensation to going to her head" and was not feeling well. Patient was breathing, alert, and conscious. She did not state that she had any medical conditions that could be contributing to the reaction. A nurse who was shopping at the store also stopped to assist. Out of precaution, 911 was called and paramedics arrived on site. Blood pressure and heart rate were normal.
54 2021-03-18 migraine First dose - Got up with every joint aching in my body, as if I had the flu, along with terrible mig... Read more
First dose - Got up with every joint aching in my body, as if I had the flu, along with terrible migraine and extremely tired. Second dose - had the very same side effects as dose 1, slept many hours the next day.
54 2021-03-18 pain in extremity Left arm soreness on same day/night; This is a spontaneous report from a contactable consumer (patie... Read more
Left arm soreness on same day/night; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 54-year-old, via an unspecified route of administration, administered in left arm on 15Feb2021 13:00 (Batch/Lot Number: EN9581) as single dose for COVID-19 immunisation. Medical history included treated with high blood pressure. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient experienced left arm soreness on same day/night on 15Feb2021 19:30 with outcome of recovered. No treatment was given for the event.
54 2021-03-18 pain in extremity sore arm
54 2021-03-18 tingling, weakness Mild adverse effects. Still experiencing. Low grade fever (102.4), headache, weakness, aching/tin... Read more
Mild adverse effects. Still experiencing. Low grade fever (102.4), headache, weakness, aching/tingling joints, lightheadedness, very sleepy
54 2021-03-19 night sweats Fatigue, feverish, chills, night-sweats.
54 2021-03-20 feeling hot, cold sweat I had the vaccine on Wednesday and Friday morning i woke up with a headache; feeling hot and clamy; ... Read more
I had the vaccine on Wednesday and Friday morning i woke up with a headache; feeling hot and clamy; feeling hot and clamy; nausios; i could not breathe; It was like a really bad asthma attack; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EN6208), via an unspecified route of administration i as single dose in arm left on 10Mar2021 for COVID-19 immunisation. Medical history included known allergy to penicillin. The patient's concomitant medications were not reported. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 04:30 morning the patient experienced woke up with a headache, feeling hot and clamy, nausios. She took Iboprofin and was fine. On 12Mar2021 night she went to bed about 10 pm and woke up from a sound sleep about 12:30 am she could not breathe. It was like a really bad asthma attack which she have never had like that. It took a while to try to breath thru her nose but finally she was able to and took a nebulizer treatment with Abutero. She was very scary. She was wondering if she should take the 2nd dose. The events were considered life threatening. Therapeutic measures were taken as a result of events. Covid was not tested post vaccination. The outcome of events was not recovered.
54 2021-03-20 migraine Migraine headache, chills and fatigue
54 2021-03-21 numbness Starting at 5 p.m. on March 18th (two days post-vaccine), pain began in the lymph node area of the l... Read more
Starting at 5 p.m. on March 18th (two days post-vaccine), pain began in the lymph node area of the left side of the neck. It became increasingly painful on March 19 in the evening (especially after dinner) and overnight (around 3 a.m.) and more painful in the evening on March 20th after dinner. On March 20th, I took 800 mg ibuprofen (4 tablets) at 6 p.m. to relieve the pain. My husband is an Emergency Physician and indicated that is the dose I should take given the pain. At 1:00 p.m. on Sunday the lymphnodes on the left side of the neck began hurting again (excruciating pain) and I again took 800 mg of ibuprofen to relieve the pain. This occurred after having lunch (a burger) at noon. However, at 1:30 p.m. the left side of my face began to feel numb. I had little control of the left side of my mouth and could not close my left eyelid properly. The numbness lasted for about 20 min and then subsided. After 40 min (2:10 p.m.) it felt better and I had a few potato chips left over from my lunch. The numbness started again about 10 min later and lasted about 20 min. The face went numb again the evening of March 22nd for 20 min despite remaining on ibuprofen 3 times a day.
54 2021-03-21 migraine Migraine style headache and diarrhea
54 2021-03-21 tingling Tingling down right arm, vitals within limits, 134/78, P-68,R-18, O2 97%, client refused EMS transpo... Read more
Tingling down right arm, vitals within limits, 134/78, P-68,R-18, O2 97%, client refused EMS transport. client is waiting in her cr till she feels 100% and then she will go on her way home. Pt. reassessed multiple times to use EMT for transport, but pt. refused stating "I feel fine, I want to go home.
54 2021-03-21 tenderness When I laid down for bed my tongue felt weird on my left side. I looked in the mirror and the left ... Read more
When I laid down for bed my tongue felt weird on my left side. I looked in the mirror and the left side of my face was swollen around the cheek. I have a little soreness around the jaw. My left are was sore to the touch and slight stiff where I cannot raise my arm all the way. I took 2 Benadryl tablets.
54 2021-03-22 inability to speak, slurring Approximate 20 hours after receiving dose #2 of vaccine, presented with symptoms of stroke: aphasia... Read more
Approximate 20 hours after receiving dose #2 of vaccine, presented with symptoms of stroke: aphasia, unable to process thoughts quickly, unable to write legibly, jarbled speech. I was working night shift at the hospital. I was immediately taken to the emergency department. Placed on monitor, labs drawn, neurochecks, EKG. Could not identify some simple pictures, could not recall my co-workers name ( worked with her for 25 years). CT done within 15 minutes of symptoms. MRI completed. Episode lasted approximately 45 minutes.
54 2021-03-22 weakness, burning sensation, migraine The night of the injection I had a headache and chills no fever. In the morning my headache was a m... Read more
The night of the injection I had a headache and chills no fever. In the morning my headache was a migraine no energy and a rash on forehead. My evening my head was on fire and blister formed on rash. My ear was ringing and hurt It was painful to swallow. Went to ER and was Dx with shingles was prescribed valtrex 1gram q8 hours and lotramin lotion
54 2021-03-22 weakness Arm and vaccination site not sore until this morning, but tolerable. Felt very sleepy starting at ar... Read more
Arm and vaccination site not sore until this morning, but tolerable. Felt very sleepy starting at around 5:30pm yesterday. Had a good night sleep but very tired and sleepy this morning. Low energy.
54 2021-03-22 weakness After only having the first dose (1 of 2): extreme light headed, nausea, weakness, no balance, pain... Read more
After only having the first dose (1 of 2): extreme light headed, nausea, weakness, no balance, pain in upper right side ribs below arm pit, Received shot for nausea and stayed in bed all day - mostly better the next day and normal the following day.
54 2021-03-22 migraine Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued na... Read more
Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued nausea & migraine. Tuesday 3/9 went to ER with same symptoms. Was admitted to hospital on 3/9 with acute kidney injury, nausea & Migraine. Was discharged from hospital on 3/14. Followe up with primary doctor on 3/17. Primary DR requested more bloodwork. Had low potassium. Ended up back in ER 3/17 with nausea and vomiting. They pushed more fluids and sent me home. Will have follow up blood work on 3/26 and next Dr appointment on 4/19. Returned to work for 1/2 day on 3/22. Absent 3/23 for extreme fatigue.
54 2021-03-22 migraine Patient reports migraine day after covid shot.
54 2021-03-22 tingling Patient received first dose of Pfizer and started having tingling in her hands and feet. EMS respond... Read more
Patient received first dose of Pfizer and started having tingling in her hands and feet. EMS responded and took Vital Signs, BP 130/80, O2 sats 99, HR 105. Patient had taken her personal albuterol inhaler prior to EMS response she stated. Patient refused any further treatment and had recovered within few minutes.
54 2021-03-23 numbness Pt. reported feeling left sided cheek numbness 5 minutes. This RN performed Stroke Scale on pt and p... Read more
Pt. reported feeling left sided cheek numbness 5 minutes. This RN performed Stroke Scale on pt and pt had no neurological deficits. When asked pt about decreased sensation pt denies any difference in sensation but reported numbness. Stated all areas of body felt the same when checked. Pt had clear breath sounds, bilaterally, no swelling noted, able to swallow secretions. Pt was A&Ox4 with GCS of 15. Pt was able to ambulate under own power and steady gait. Pt denies any other issues. Pt requested to go to hospital and EMS was then notified.
54 2021-03-23 pain in extremity I received the vaccine at 7:45 am 3/23/21 and at 11:00am left arm was sore and is continuing to be s... Read more
I received the vaccine at 7:45 am 3/23/21 and at 11:00am left arm was sore and is continuing to be sore through 12:25pm 3/24/21. Arm is continuing to be sore Also around 9:30 am 3/24/21, I had an upset stomach which led to several loose bowel movements up through 12:45pm so far.
54 2021-03-23 pain in extremity Chest pain, chest tightness, stomach upset, diarrhea , headache, arm soreness, brain fog
54 2021-03-23 pain in extremity Body aches Chills Headache Sore arm
54 2021-03-23 pain in extremity The day after vaccine thigh pain, 5 days after vaccine, thighs start have Shingles Visit doctor on 3... Read more
The day after vaccine thigh pain, 5 days after vaccine, thighs start have Shingles Visit doctor on 3/22/21, doctor prescribes medicine ? Zovirax?
54 2021-03-23 tingling, pain in extremity Upon injection are immediately was tingly down the outer aspect across outer forearm down hand into ... Read more
Upon injection are immediately was tingly down the outer aspect across outer forearm down hand into fingers. Lasted about 30 minutes. About 4pm arm started to be sore. During the night started running a fever, 101.8 body hurt all over. Felt like I weighed 600 pounds and couldn?t move. Started in the top of my head, neck, shoulders, back, hips, thighs, knees, ankles, and feet. Very tired. No appetite. So much pain doctor ordered toroidal. Pain under left arm. Now about 36 hours later feeling much better. No fever, little more energy, pain is better but still taking toroidal so not sure.
54 2021-03-24 weakness delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills;... Read more
delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills; joint pain; pain at the injection site; lethargic; dry cough; severely nauseous; could not eat; serious fogginess; General malaise; fatigued; a debilitating headache; did not feel comfortable driving; weak; hurt in my chest; slept the whole day; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 13:30 (Batch/Lot Number: EN6202) at 54-years-old as a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Medical history included hypertension, and acne from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included hydrochlorothiazide, olmesartan medoxomil (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; isotretinoin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient previously took (ceftriaxone sodium) ANCEF, start and stop date were not reported, and experienced drug allergy. On 06Mar2021 at 04:00 (as reported), the patient experienced: delirious as if i was hungover (medically significant), felt on the brink of fainting (non-serious), chills (non-serious), joint pain (non-serious), pain at the injection site (non-serious), lethargic (non-serious), dry cough (non-serious), severely nauseous (non-serious), could not eat (non-serious), serious fogginess (non-serious), general malaise (non-serious), fatigued (non-serious), a debilitating headache (non-serious), did not feel comfortable driving (non-serious), weak (non-serious), hurt in my chest (non-serious), slept the whole day (non-serious); with no treatment received. The clinical course was reported as follows: The patient reported that on the first night (as reported) she had chills, joint pain and pain at the injection site. The next day (as reported) she was lethargic and was severely nauseous to the extent she could not eat. The patient also experienced serious fogginess, felt delirious as if she was hungover. The patient felt general malaise and a debilitating headache all day. The patient was fatigued to the extent she did not feel comfortable driving. The patient was so weak, that she felt on the brink of fainting. That evening, the patient slept the whole night through, except when she would awake with a dry cough that hurt in her chest. This cough was not as persistent and intense but was lasting even now. The patient slept the whole day and was just now beginning to feel as if she had recuperated from the vaccine four days later. The clinical outcome of the events was recovered with sequelae on an unspecified date (also reported as "recovered with lasting effects"). The patient was not tested for COVID post vaccination.
54 2021-03-24 flushing Pt developed a flushed feeling along with lightheadedness. She notes that it feels similar to prior ... Read more
Pt developed a flushed feeling along with lightheadedness. She notes that it feels similar to prior episodes of vertigo. Symptoms came on almost immediately after vaccination. BP 120/80, HR 73, SP02 98%. She ate a snack and felt slightly better and elected to go home with her husband driving. She declined EMS services and ER evaluation,
54 2021-03-24 pain in extremity Arm was sore as expected. Red spots developed on chest first. They do not itch or hurt. I didn?t ... Read more
Arm was sore as expected. Red spots developed on chest first. They do not itch or hurt. I didn?t notice that the spots were all over the torso - back, abdomen, breast, and I may have some on scalp. My allergy Dr described as fixed drug eruption and said the spots look like nummelar dermatitis - even though no itching. She prescribed Triamcinolone and I just started using. I first went to my internist and she had no clue what it was or how to help. I?ve never had anything like this ever - the only thing I?ve done differently in the last 3 weeks was getting vaccinated. No way I?m getting the second dose.
54 2021-03-24 tingling About 30 minutes after, arm and face became really hot. Then it turned into tingling, pins and needl... Read more
About 30 minutes after, arm and face became really hot. Then it turned into tingling, pins and needles along my whole left side. I am still having this as of today 3/25/21
54 2021-03-24 tingling Feeling "light" and tingling in hands and lips
54 2021-03-24 sensory loss, weakness The day after my second dose of the Pfizer vaccine, I experienced chills, severe body aches, stomac... Read more
The day after my second dose of the Pfizer vaccine, I experienced chills, severe body aches, stomach upset, vomiting. I had loss of sensitivity in my right thigh area that comes and goes. I also have brain fog, joint aches that overwhelming. Subsequently, I had Covid tests through my PCP which were negative but I had symptoms that mimicked Covid symptoms. My PCP recommended I go to the ER and I was admitted for two and a half days. They monitored my heart, did lab work, liver test. I continue with headaches that are more profound. I still have loss of strength in my right thigh, which is intermittent, comes and goes. I still have itchiness on my right thigh and leg with loss of sensation lasting from three to five hours. I will be seeing a neurologist next month.
54 2021-03-25 flushing, feeling hot hot/flushed. monitored in ER
54 2021-03-25 flushing Immediately after vaccination patient felt flushed and had "a funny taste in her mouth". She was eva... Read more
Immediately after vaccination patient felt flushed and had "a funny taste in her mouth". She was evaluated by an on-site EMT and symptoms resolved within 30 minutes. Patient has a history of panic attacks.
54 2021-03-25 numbness Immediate runny nose and terrible headache. After about 8 minutes, lip feeling weird. After 25 min... Read more
Immediate runny nose and terrible headache. After about 8 minutes, lip feeling weird. After 25 minutes of receiving shot, numb chest, neck, lower fac3 - and swelling of throat and lower face. The numbness and swelling lasted for approximately 3 hours.
54 2021-03-25 night sweats Dizziness, confusion, nausea, night sweats, lack of concentration & inability to think clearly. Ext... Read more
Dizziness, confusion, nausea, night sweats, lack of concentration & inability to think clearly. Extreme fatigue & quickly becoming short of breath from walking. Rapid/racing heartbeat. Started evening of the vaccination & continued through the entire day on 3/24, the day after the vaccine. Went to bed at 5:30pm on the 24th and felt much better on the morning of the 26th.
54 2021-03-25 pain in extremity, numbness Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for... Read more
Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for over 12 hours. Left side of the neck pain, left lymph node glands under the arm severely swollen, earache and left side, and extreme fatigue. Now 43 hours later after the injection I can move my arm but still cannot touch the site of the injection, left ear still hurts, left side of neck still painful but better. Can now lift arm above had but still feels very heavy. The lymph node glands under her left arm has reduced in size but still sore to the touch. I?ve been taking ibuprofen for the last two days to help with the discomfort.
54 2021-03-25 pain in extremity pain in left arm, swollen lymph node in the neck on the left side, measures approximately 1.5 cm, no... Read more
pain in left arm, swollen lymph node in the neck on the left side, measures approximately 1.5 cm, not painful, movable.
54 2021-03-25 pain in extremity Sore Arm, light swelling.
54 2021-03-26 pain in extremity Following day: vertigo, nausea, fatigue, chills, throbbing pain in both legs (all over), headache, ... Read more
Following day: vertigo, nausea, fatigue, chills, throbbing pain in both legs (all over), headache, sore arm, had to urinate every 15 minutes for approximately 12 hours. These symptoms lasted about 48 hours. Morning vertigo or just dizziness every morning since day of shot. Nausea every day since day of shot.
54 2021-03-26 tingling Throat tightness and dryness, facial tingling. After 10 minutes, persistent and worsening throat tig... Read more
Throat tightness and dryness, facial tingling. After 10 minutes, persistent and worsening throat tightness, facial tingling. Given Epipen and albuterol. Sent to ED.
54 2021-03-27 pain in extremity Mild sore arm x 2days , fatigue x2days and lymphadenopathy of bilateral axillae and swelling of righ... Read more
Mild sore arm x 2days , fatigue x2days and lymphadenopathy of bilateral axillae and swelling of right breast x5 days
54 2021-03-28 weakness, slurring heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immed... Read more
heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immediate overall body weakness; slurred speech; lips tingling; disoriented; lightheaded; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration, at the age of 54 years, on the left arm on 08Mar2021 15:00 at a single dose for COVID-19 immunisation. Medical history included fibromyalgia, musculoskeletal disorder, drug hypersensitivity to penicillin, other food sensitivities and gluten sensitivity; all from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); ascorbic acid (C 500 [ASCORBIC ACID]); colecalciferol (D3) and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient previously took progesterone, NP thyroid and lactose and experienced hypersensitivity. On 08Mar2021, the patient immediately felt the medications moving throughout her body. She felt immediate overall body weakness, slurred speech, lips tingling, disoriented, lightheaded, and heart discomforted. The medical staff took her blood pressure 30 minutes after the injection and it was 184/124. She stated she was not hypertensive. The final read before leaving the site was 149/90. No treatment was received for the events. The outcome of the events was recovering.
54 2021-03-28 discomfort Worsening of existing light tinnitus. Prior to COVID vaccine, had only a small, barely noticeable r... Read more
Worsening of existing light tinnitus. Prior to COVID vaccine, had only a small, barely noticeable ringing in my ears. Now, the ringing is accompanied by a heaviness, throbbing. Not painful but distracting and makes me feel foggy.
54 2021-03-28 flushing, burning sensation Sudden onset of red flushed face, burning sensation of face, red bloodshot eyes 30 hours post inhjec... Read more
Sudden onset of red flushed face, burning sensation of face, red bloodshot eyes 30 hours post inhjection No other body part impacted. No fever, no other symptoms
54 2021-03-28 flushing 03/11/2021- 'hypertensive crisis, post 1st Pfizer, approx 1.5hrs later had pounding HA, went to UC,... Read more
03/11/2021- 'hypertensive crisis, post 1st Pfizer, approx 1.5hrs later had pounding HA, went to UC, elevated BP, went back to work, 'massive' HA, feeling unwell, fluttering in chest, flushed feeing, went back to UC but ct decided to go to ER, BP 187/126, low Na/K levels, hx HTN, ER changed BP meds, hrt monitor on x 48hrs. Night before getting C-vaccine, flushed, feeling unwell. PCP ok'ed 2nd dose at hospital.
54 2021-03-28 tingling, numbness This side effect randomly happens to me 2-3x/year, I wasn't overly concerned and just watched it. I ... Read more
This side effect randomly happens to me 2-3x/year, I wasn't overly concerned and just watched it. I have no idea what triggers it so it may not be vaccine-related Vaccine: 9am MT. About 25 minutes after the vaccine (9:25am) , my lips started tingling and went numb. Within 10 minutes or so, the tingle/numbness travelled to my entire face and inside my mouth and tongue. I waited 90 minutes then self-treated with two Benadryl tablets (11am). Tingle/numb were gone 1-1:30ish.
54 2021-03-28 tremor Within 18 hours of dose 1, I woke with fever, chills, shaking, and body aches.
54 2021-03-29 cold sweat fainted a couple of mins, regained consciousness but feeling light headed, nauseated reported a col... Read more
fainted a couple of mins, regained consciousness but feeling light headed, nauseated reported a cold sweat. had diarrhea. was not still feeling well so 911 called and was taken to a hospital
54 2021-03-29 facial paralysis Right side of face is red and small blisters formed. Right eye feels droopy and slight headache. ... Read more
Right side of face is red and small blisters formed. Right eye feels droopy and slight headache. Also red and swollen in left are where I received the injection.
54 2021-03-29 feeling hot, pain in extremity Arm at injection site became very warm and I could feel a warmth spreading both down my arm and up ... Read more
Arm at injection site became very warm and I could feel a warmth spreading both down my arm and up through my neck. The feeling lasted for approximately 5 minutes and then went away. My arm was very sore about 12 hour later and lasted fir about 3 days.
54 2021-03-29 feeling hot 2:31 pm- Almost immediately after receiving vaccination, Pt started to experience red blotching over... Read more
2:31 pm- Almost immediately after receiving vaccination, Pt started to experience red blotching over neck, upper chest, and upper arm regions. No complaints of shortness of breath, but stated she felt hot. Pt was moved per wheelchair to cooler area, wheelchair locked, and given water. 2:32pm- Vitals as follows B/P 147/109, HR 105, R 20, O2 sat -, 94%. Pt stated she took Benadryl approximately 2 hours before coming to site, as she stated she has had similar experiences with other vaccines. Pt stated she began to feel better immediately. 2:45 pm-. O2 sat now 95%. Reassessed by Firefighter, and he gave the ok to release pt to home. Pt taken to her car per wheelchair, and again she stated that she felt much better.
54 2021-03-29 numbness Pt reported on 3/30/2021 Back pain & numbness in leg w/1st dose and worsened experience with pain af... Read more
Pt reported on 3/30/2021 Back pain & numbness in leg w/1st dose and worsened experience with pain after second dose. No numbness. 2/9/2021 Office Visit: 1. Sacroiliitis Patient will start Mobic daily. She will call if symptoms worsening over the next couple of days and we will consider starting muscle relaxant. Discussed PT eval also, so patient declined at this time. - meloxicam (MOBIC) 7.5 MG tablet; Take 1 tablet by mouth daily. Dispense: 30 tablet; Refill: 1 2. Anxiety The patient likely has inflammation of her left SI joint secondary to her immune response to the COVID vaccine. There were no back muscle spasms noted but she did have tightness in her hamstring, which could explain the radiation of the pain down her leg. There are no symptoms concerning for an infectious etiology of the joint. No recent injury or neurological symptoms, making bone and nerve injury less likely. Plan to start the patient on Mobic to reduce inflammation in the SI joint. Advised that if her symptoms do not improve by the end of the week, we can consider adding flexeril. 2/15/2021 Started Physical Therapy. DX lumbar back pain with rediculapathy affecting Left Lower Extremety, Sacroiliitis, Impaired functional mobility and activity tolerance.
54 2021-03-29 pain in extremity Developed shingles with rash and pain on right side of chest/torso/back and under arm.
54 2021-03-29 pain in extremity Swelling in lymph nodes through out body- initially in groin then under both arms. Intense fever tha... Read more
Swelling in lymph nodes through out body- initially in groin then under both arms. Intense fever that broke in 3 hours, then ongoing fever and chills for 12 hours. 24 Hours later- still have swelling in lymph under left arm where injection was. By 56 hours post injection lymph still swollen and arm very sore.
54 2021-03-29 cold extremities 12:30 AM - minor headache, body aches, trouble sleeping, pain at injection site 2:30 AM - freezing c... Read more
12:30 AM - minor headache, body aches, trouble sleeping, pain at injection site 2:30 AM - freezing cold hands, cold feet and body, minor headache, body aches, trouble sleeping, pain at injection site 6:30 AM - minor headache, body aches, trouble sleeping, fainting, pain at injection site
54 2021-03-29 seizure Received second vaccine dose. Lay on cot and began to have a seizure. Vitals obtained and rolled on ... Read more
Received second vaccine dose. Lay on cot and began to have a seizure. Vitals obtained and rolled on side. EMS called Complained of headache dizziness fatigue after woke from first seizure. Then had another seizure.
54 2021-03-30 burning sensation, hot flush 3/27 the morning after the shot Large Scarlet colored blotches were noted all over face and neck. T... Read more
3/27 the morning after the shot Large Scarlet colored blotches were noted all over face and neck. These blotches were 3 to 5 inches in diameter. Face felt "burning hot" Also present were Extreme full body heat flashes, lightheadedness and dry mouth. 3/28 the blotches were not faded but started to become raised. 3/29 the blotches became dry and irritated. Treated with increased water intake and 25 mg Benadryl at night. Cool rags to the face to relieve the heat.
54 2021-03-30 cold sweat, burning sensation, feeling hot Rec'd vaccine at 12:30pm. Next couple hrs were normal, except tasted a fume-like vapor in back of t... Read more
Rec'd vaccine at 12:30pm. Next couple hrs were normal, except tasted a fume-like vapor in back of throat. By 6 pm I started feeling aches, especially my joints and muscles. Was at a laundrymat and pulling clothes out of dryer -felt impossible to hold them up...burning and aching in shoulders and neck. Feel waves of fatigue. Left, went home...felt hot and clammy. Took temp- it was 101.7. Took tylenol, gabapentin, and went to sleep in recliner. Woke up at 11 pm, severe muscle weakness...so much that by the time I got out of the recliner...and on my feet...I already began to urinate on myself. It was like I could not control my body...I had very little ability to get up and out of recliner...everything was so HEAVY....my arms and legs were "weighted". After using restroom...it took 15 min just to change out of soiled clothing and clean up...and re-dress. I laid down in the bed, but was very uncomfortable...so went back to recliner. Was physically unable to get the lid off the tylenol after trying very hard....I fell back to sleep. At 3:15 am I woke up needing to pee, and once recliner was at normal seated position...I struggled to use my arms to lift myself up...my right arm, where I got vaccine hurt badly...it felt like PAIN...like beyond sore. I pitched to floor cuz legs wouldn't hold me. My fever was 103.7... J feel hard-pressed to finish cuz I got a warning im about to time out. Guess I hope someone contacts me. I hav
54 2021-03-30 flushing 03/11/2021- 'hypertensive crisis, post 1st Pfizer, approx 1.5hrs later had pounding HA, went to UC,... Read more
03/11/2021- 'hypertensive crisis, post 1st Pfizer, approx 1.5hrs later had pounding HA, went to UC, elevated BP, went back to work, 'massive' HA, feeling unwell, fluttering in chest, flushed feeing, went back to UC but ct decided to go to ER, BP 187/126, low Na/K levels, hx HTN, ER changed BP meds, hrt monitor on x 48hrs. Night before getting C-vaccine, flushed, feeling unwell. PCP ok'ed 2nd dose at hospital.
54 2021-03-30 muscle spasms, pain in extremity uncharacteristic, random muscle cramping and pain in response to usual physical exertion and during ... Read more
uncharacteristic, random muscle cramping and pain in response to usual physical exertion and during periods of rest; whole body but mostly in lower legs uncharacteristic pain and muscle fatigue in lower legs after standing 10 minutes time course: continuous since onset of symptoms There has been no change to my pre-vaccine medication, diet, or physical-activity routines that could account for these muscular symptoms.
54 2021-03-30 tremor, tingling Fine tremor at rest and with intention to LUE/hand; pain and paresthesia onset 1 day after vaccine, ... Read more
Fine tremor at rest and with intention to LUE/hand; pain and paresthesia onset 1 day after vaccine, tremor 2 days after vaccine
54 2021-03-31 weakness, night sweats 3/25/21- 6:30 pm vaccine shot 3/26/21 ~ 9:30- 10:00 am Chills, high fever reaching 103 (rising stead... Read more
3/25/21- 6:30 pm vaccine shot 3/26/21 ~ 9:30- 10:00 am Chills, high fever reaching 103 (rising steadily throughout the day after injection), fatigue, confusion, wiped out, couldn't move for 7-8 hours, unable to stay awake or focus/function on anything, Fever broke about 6 pm after taking Tylenol a couple hours earlier. Nausea, and weak 3/27/21- fatigue, body aches (lower back hurt, head hurt), night sweats 3/28/21 fatigue, body aches (lower back hurt, shoulders and neck hurt, stiff neck, body temperature dropped to 96
54 2021-03-31 numbness, tingling About 4 hours after receiving my first shot my hands and feet started tingling. It then progressed ... Read more
About 4 hours after receiving my first shot my hands and feet started tingling. It then progressed to feelings of needles sticking my hands and feet. The next day if felt better so I thought nothing of it. But by the day following my hands were beginning to tingle again and my toes felt tingly/numb when I would walk. I finally decided to contact my doctor's office. They suggested I come in to see my Doctor. My doctor said they have been seeing this at times. She suggested I double up on my Zyrtec and start taking B complex. She said it my take a few weeks to subside. Luckily by day seven all tingling and needle pricking sensation was gone. She told me I should still get my 2nd shot, which I will receive on April 5. She also told me to report my reaction to the CDC.
54 2021-03-31 pain in extremity Sore arm, body aches, nausea, headache, extreme fatigue
54 2021-03-31 pain in extremity After 1st shot : arm soreness, raised red and hot to touch. Pain in hips as day went on, pain trave... Read more
After 1st shot : arm soreness, raised red and hot to touch. Pain in hips as day went on, pain traveling to lower extremities, then upper extremities. Lethargy and chills. After 2nd shot: Similar s/s but worse than 1st dose. Painful to move upper and lower extremities, extreme lethargy, slight temp, overall unwell feeling. My concerning issue is that arm soreness diminished after few days but then returned at approximately 3 weeks after 2nd dose . As of right now, I?m continually feeling pain, sometimes sharp and radiating pain above and below site. Seems to be covering more area of arm, armpit.I have hard time sleeping on left side, waking up from pain if on it too long, weakness in left arm, pain if lifting arm or turning it certain directions. If I press on injection site i can feel pain and tenderness. Affecting daily living. I?m also a nurse and it?s worrying me at this point.
54 2021-03-31 tingling, hot flush March 31 - received vaccine and immediately within 2-3 minutes experience moderate anaphylaxis: Thro... Read more
March 31 - received vaccine and immediately within 2-3 minutes experience moderate anaphylaxis: Throat constricted, rapid heartbeat, hot flash, tingly face. But breathing was normal throughout. Within minutes was given EpiPen, followed by intravenous Benadryl. Then taken to ER to later receive steroids. Was observed in ER for 4 hours, with no reoccurrence of symptoms. Prescription for Prednazone (3 day course) and Benadryl (as needed). Epi Pen if needed. April 1 - Next day, felt totally normal. Slight soreness in arm, and very minor fatigue. was able to work, drive, and go about normal activities.
54 2021-04-01 burning sensation 7 days after 1st dose of Pfizer vaccine upper right thigh/hip area (skin sesitivity) burning sensati... Read more
7 days after 1st dose of Pfizer vaccine upper right thigh/hip area (skin sesitivity) burning sensation that resembles Shingles-but with no rash present. I had Shingles back in 2019 on (R) buttocks area-same skin sensitivity burning sensation.
54 2021-04-01 burning sensation Swollen arm and arm pit area with burning sensation intermittent. Still feel pain off and on after ... Read more
Swollen arm and arm pit area with burning sensation intermittent. Still feel pain off and on after 5 days in my armpit/breast area
54 2021-04-01 feeling cold At or before 10 minutes after administration of COVID vaccine, patient felt light headed, dizzy, sha... Read more
At or before 10 minutes after administration of COVID vaccine, patient felt light headed, dizzy, shaky. She felt cold and shivery with an increased heart rate. Patient was drinking water and ate one cracker out of a box of saltines that was provided to her. After 15 min we called 911. The emergency services cleared her to leave with her sister driving her home. She was told that if she did not feel better in a few hours, she was to go to the ER.
54 2021-04-01 pain in extremity first day 3/31/21 - sore right arm second day 4/1/21 - sore right arm, beginning at 3:30 am fever of... Read more
first day 3/31/21 - sore right arm second day 4/1/21 - sore right arm, beginning at 3:30 am fever of 100.1, chills, headache and subsiding 9:00pm
54 2021-04-01 pain in extremity Back,thigh, and leg pain High fever
54 2021-04-01 tingling onset my extremities were tingling, fever, body aches and throbbing, headache lasted about 36 hours.
54 2021-04-02 weakness Severe vertigo, nausea, severe headache for days, weakness, exhausted physically. Body aches, sweat... Read more
Severe vertigo, nausea, severe headache for days, weakness, exhausted physically. Body aches, sweats and chills. Loss of appetite.
54 2021-04-02 pain in extremity, weakness, discomfort After the first vaccine on 2/6/2021, I did not have any reaction except a sore arm until 2/10/2021 ... Read more
After the first vaccine on 2/6/2021, I did not have any reaction except a sore arm until 2/10/2021 when developed a bad headache causing me to leave work. When I awoke on 2/11/21 I felt worse as the day went on until I had complete flu like symptoms. On Friday, 2/12, I went to my primary care doctor and they did a COVID-19 test which was negative. Hence, I just waited for the reaction to go away, I was not better and able to resume normal activity until 2/15/21. I did decide to get the second shot as I was not entirely sure it was a result of the vaccine. On 2/27/2021, I received the second vaccination. Again, the immediate side effect was only a sore arm. On the following Monday (3/1/2021) see cont.I began to have what I thought was muscle aches and pains around the mid section on my body but they were manageable. On Tuesday and Wednesday (3/3/2021) the pain and area of the pain spread and intensified. I was unable to sleep or find a comfortable position and was losing strength and knew I needed medical attention as I was afraid it was a heart issue. My husband took me to the ER (3/4/2021). The ER doctor ran a CT scan with contrast and the result was a blood clot in my right lung and pneumonia in my left lung along with pleurisy. I was then admitted to Clinic on 3/4/2021. I remained in the hospital until 3/7/2021. There I was treated with IV antibiotics, warfarin, Lovenox (80mg), and pain medication for the pleurisy. I was also on a full time heart monitor and my heart was checked several times. Since returning home, I finished a dose of two antibiotics and am using an inhaler to help with breathing. I have also just finished a long dose of steriods. My INR is still not regulated to the therapeutic level. Prior to this reaction, I was in the therapeutic range and had been checked. As of 4/3/2021 I am at 1.8 not in the 2-3 range and have increased my dose from before the reaction at 7.5 mg to 9.0 mg daily.
54 2021-04-02 pain in extremity, tremor Her temperature was 101 degrees; her arm is swollen; Dizzy; Lightheadedness; Nauseous; Shakiness; ar... Read more
Her temperature was 101 degrees; her arm is swollen; Dizzy; Lightheadedness; Nauseous; Shakiness; arm swollen; back hurts; hot where she got the injection; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0142), via an unspecified route of administration on Left arm on 08Feb2021 at single dose for covid-19 immunisation. Medical history included Flu on an unspecified date. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), at single dose for covid-19 immunisation. The patient reports, she received her second shot yesterday and her arm hurt like any shot would. She says today she feels really sick, after being fine yesterday. She says today she is dizzy and lightheaded. She says she took Advil, her temperature was 101 degrees Fahrenheit even with Advil, and every time she gets up she feels lightheaded and shaky. She says her back hurts when the Advil wears off, it is ok now because she is laying down, and she also feels a little nauseous. She says that her arm is swollen and hot where she got the shot, and this started today. She says that yesterday it just hurt like she got the flu shot. She says that she took Advil 200mg, she took two of them this morning at 06:00AM or 07:00AM, and then two more at 01:00PM. LOT: DY3057, EXP: May2023. She says by 11:00AM her fever was 101 degrees Fahrenheit, and now with the Advil it is 100.7 degrees Fahrenheit. Caller says that her lightheadedness and shakiness feel about the same. The seriousness was reported as non-serious. The outcome of the events unknown. Information on the lot/batch number has been requested.
54 2021-04-02 pain in extremity Client states that while sitting in her 15 minute observation period after 1st dose she felt a deep ... Read more
Client states that while sitting in her 15 minute observation period after 1st dose she felt a deep pain in her posterior Left thigh. She did not alert the medical staff of her pain and attempted to walk away from the observation site but due to the pain was limping. She was approached by the paramedic and lead RN outside of the facility. Vitals were taken and 911 called who advised patient should go to hospital for immediate evaluation and care. Patient refused transport and left against medical attention stating she would go to the emergency room with her daughter.
54 2021-04-02 pain in extremity Chills and extreme arm soreness for a few hours prior to fever. fever ranging from 99- 102.7 degre... Read more
Chills and extreme arm soreness for a few hours prior to fever. fever ranging from 99- 102.7 degrees for about 30 hours.. Slept for nearly 36 hours and felt exhausted and foggy for an additional 6 hours. No appetite and minor stomach upset for duration of fever
54 2021-04-02 tingling, numbness, difficulty speaking 25 minutes into a 30 minute observation following 1st dose Pfizer client reported feeling a progress... Read more
25 minutes into a 30 minute observation following 1st dose Pfizer client reported feeling a progressive hoarseness in her throat and tingling in her fingers, she stated she had a transient bout of dizziness that lasted less than a minute. Vitals were taken and client denied any other symptoms. Her symptoms improved and she stated after an additional 30 minute observation that her hoarseness in throat was resolved and fingertip numbness/tingling was resolving. Client left facility on her own accord with a steady gait.
54 2021-04-03 flushing Flushing/sweating, dizziness, and increased anxiety. Initial BP 171/108 (pulse 82). F/u BP 124/65 (p... Read more
Flushing/sweating, dizziness, and increased anxiety. Initial BP 171/108 (pulse 82). F/u BP 124/65 (pulse 74). O2 sat 100%. Patient placed in supine position and stabilized.
54 2021-04-03 tingling About 10:30 PM, started getting a slight headache with accompanying symptoms of a urinary tract infe... Read more
About 10:30 PM, started getting a slight headache with accompanying symptoms of a urinary tract infection. The urgent need to go to the bathroom and the sensation of pins and needles at the end of urinating. Trying to drink a lot of fluids but it?s not helping much. Not seeing any blood on the tissue paper at the end as with typical UTIs
54 2021-04-04 flushing, feeling hot Warm flushing feeling, numbness around site, waited 10 minutes, pt. left site.
54 2021-04-04 flushing Felt weird, dizzy, flushing/sweating, h/o multiple allergies. BPs 180/107 (pulse 126), 171/115. Give... Read more
Felt weird, dizzy, flushing/sweating, h/o multiple allergies. BPs 180/107 (pulse 126), 171/115. Given Benadryl 25 mg PO. Advised to go to ED, but patient refused.
54 2021-04-04 numbness, facial paralysis left side numbness and tingling throat 1/2 closed, right side lip
54 2021-04-04 numbness, tingling, tenderness Within few hours from the vaccination I started to feel numbness in my left cheek, left side of neck... Read more
Within few hours from the vaccination I started to feel numbness in my left cheek, left side of neck, left lower arm, left side of waist, left lower leg. The feeling in the cheek was as when you get anesthesia at the dentist. By the end of the day the numbness was almost gone except at the cheek where was also a feeling of tenderness and tingle sensation. The feeling on the cheek has lasted as of today 4/5/2021.
54 2021-04-04 tingling Patient received Pfizer (EM9810) vaccine, while in observation for 15 minutes she began to feel pare... Read more
Patient received Pfizer (EM9810) vaccine, while in observation for 15 minutes she began to feel paresthesia in LD. Five minutes after that she also began to feel nausea, no vomiting. Patient remained in observation for additional 15mins. Benadryl 25mg P.O was provided and patient stated she began to feel better 10 minutes after taking Benadryl. She noted feeling better when face mask was off.
54 2021-04-05 weakness Zero pain with injection. Immediately upon the needle leaving my arm I began to feel dizzy and reall... Read more
Zero pain with injection. Immediately upon the needle leaving my arm I began to feel dizzy and really weak. Thought I was going to pass out but didn?t . My tongue felt funny almost electric. Then my heart took off and raced for a good bit. Just felt really washed out. It was a drive through clinic we did not alert anyone. Felt my husband would get someone if I passed out. Felt really tired for the rest of the day and had heart palpitations throughout the following week. I?m now fine. Called in to my primary and they advised I should report
54 2021-04-05 pain in extremity 1130: Patient complained of slight headache (8 out of 10) at end of 15 minute observation. Also no... Read more
1130: Patient complained of slight headache (8 out of 10) at end of 15 minute observation. Also notes slight chills, joint pain in left arm and slight dizziness. States she did eat this AM.DENIES: Trouble swallowing, chest discomfort or shortness of breath. VITALS: P 60, BP 138/99 (regular cuff, left arm), pulse Ox 100% room air. 1140: Patient states headache worsening. Dizziness about the same. Breathing unaffected. VITALS: BP 143/89 (large cuff, left arm). Lights dimmed, patient assisted to sitting position on exam table with back support. 1155: Dr. assessed patient with no concerns. Advised ongoing monitoring for 15 minutes. 1205: BP 122/83 (large cuff, left arm), P 56 Patient still c/o headache and dizziness is only a little better. Patient declined wheelchair out of building but agreed to this RN calling to check on her in 1-2 hours. She feels comfortable driving the short distance home. Second vaccine scheduled with number provided in case she decides against receiving 2nd shot.
54 2021-04-05 pain in extremity Severe chills started 17 hours after shot. 20 hours after shot my heart started racing really bad a... Read more
Severe chills started 17 hours after shot. 20 hours after shot my heart started racing really bad and I was very breathless. I tried to sleep, but kept jolting awake and felt like I had quit breathing. I was lightheaded. Arm/neck/shoulders really sore. Chills went away after about 7 hours. The chills came back 5 hours later (April 1 at 10:00 pm). When I woke up on April 2, I felt better, but was extremely exhausted. I felt really "off" through April 4. (Off meaning: breath kept getting caught in my throat, bouts of lightheadedness, slight tightness in right side of chest)
54 2021-04-05 seizure Patient received vaccine no issues, waited 15 minutes reported no issues, left pharmacy for approxim... Read more
Patient received vaccine no issues, waited 15 minutes reported no issues, left pharmacy for approximately 5 min, returned complaining for dizzyness, we got her water and had her sit down, she began having seizures, she had 5 episodes before emd arrives, she was taken by ambulance
54 2021-04-05 tenderness Within 5 minutes of injection, seated for 15 minute watch period, I felt nauseous, followed by light... Read more
Within 5 minutes of injection, seated for 15 minute watch period, I felt nauseous, followed by lightheadedness, racing heart, felt like I couldn't get enough air, and slight tightness in my chest, and was concerned I was going to pass out / fall off of my chair. I was double masked, and removed one mask to get more air. No medications were administered to treat the adverse event. After about 7 minutes, symptoms started to subside. Within 20 minutes was mostly back to normal, but was nauseous the remainder of the day. Stayed for a 30 minute watch period. Upon returning home, within 1 hour of receiving vaccine, first I felt like I was getting the flu, and took a Sudafed. Then I was exhausted and could not keep my eyes open, and slept for 3 hours. No recurring symptoms that evening or the following day. Injection site became very sore about 24 hours after injection, with minimal heat emanating from skin. Soreness changed to tenderness in 2-3 days, and completely subsided within 4-5 days. Took Tylenol and Alleve for soreness.
54 2021-04-06 weakness, pain in extremity headache weakness no energy confusion very sore arm where shot was given Lasted 1 1/2 days
54 2021-04-06 weakness Flu like symptoms, chills, body aches and legs have lost temporary strength.
54 2021-04-06 numbness, bell's palsy pt. states Sx of numbness in facial area. provider stated it was bell palsy after hearing full repor... Read more
pt. states Sx of numbness in facial area. provider stated it was bell palsy after hearing full report of Sx.
54 2021-04-06 numbness Within minutes of getting the shot I got a metal taste in my mouth and my mouth/lips/cheeks ON THE L... Read more
Within minutes of getting the shot I got a metal taste in my mouth and my mouth/lips/cheeks ON THE LEFT SIDE ONLY started getting numb. Paramedics took my blood pressure (usually normal) and it was very high (around 150/105). Paramedics monitored my blood pressure until it went back to normal (30-40 minutes), then I went home. The numbness got worse for 2-3 hours (eventually the area of my face around my left eye also got numb). Then the numbness started to slowly fade and it was totally gone in 48 hours.
54 2021-04-06 migraine Migraine
54 2021-04-06 tremor Systemic: Dizziness / Lightheadness-Medium, Systemic: anxiety due to shot. has anxiety disorder-Medi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: anxiety due to shot. has anxiety disorder-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
54 2021-04-07 cold sweat Dizziness; clammy kind of feeling; low grade fever; feels kind of sweaty; felt like she was going to... Read more
Dizziness; clammy kind of feeling; low grade fever; feels kind of sweaty; felt like she was going to pass out; blood pressure was up; This is a spontaneous report from a contactable consumer reported for herself that at the age of 54- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration on 15Mar2021 (at the age of 54-year-old), at a single dose for COVID-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. Caller reports that since she received the vaccine on 15Mar2021, on the day of the vaccine, she felt like she was going to pass out and her blood pressure was quite high. Her blood pressure is usually about 120/70 something, but it was 160 or 155/96 on the day of the vaccine. The reporter stated, she has been experiencing a clammy kind of feeling, like she has a low-grade fever and she feels kind of sweaty on 16Mar2021. Caller make the comment that she is in her fifties and she knows what hot flashes feel like-your body gets hot, sweaty, and you get redness on your skin, and your temperature goes up. This feeling is different- she doesn't feel like herself and she doesn't feel right and she is not sure if this is related to the vaccine, but it started after she received the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: 120/70 on an unspecified date and on 15Mar2021 reported as: 160 or 155/96 on 15Mar2021. The reported events were considered as non-serious by the health authority. The outcome of the events clammy kind of feeling, low grade fever and feels kind of sweaty were not recovered and unknown for other events. Information for lot/batch number has been requested.
54 2021-04-07 pain in extremity Arm pain, redness, swelling, severe headache, fatigue, muscle soreness, chills.
54 2021-04-07 pain in extremity Severe pain in left arm from shoulder to hand both top and bottom of arm that worsens with activity.
54 2021-04-07 pain in extremity Fatigue, headache, nausea, throbbing pain in arm (worse than a sore arm)
54 2021-04-07 tingling, numbness pruritis, headache, facial paresthesias/numbness, vertigo
54 2021-04-08 weakness Patient recently left vaccine observation area and noted she was "I am feeling funny/weak and that s... Read more
Patient recently left vaccine observation area and noted she was "I am feeling funny/weak and that she had just obtained the COVID vaccine." with pre-syncopal episode. Patient taken to ED for evaluation. Given IV fluids and discharged from ED.
54 2021-04-08 nerve pain Systematic Inflamation 7 days post injection. Swollen hands/feet (10 days), Hiccups, stomach crampin... Read more
Systematic Inflamation 7 days post injection. Swollen hands/feet (10 days), Hiccups, stomach cramping (no nausea or diarrhea ), neck nerve pain that went behind shoulder blade (couldn't move for 3 days), bubbles in the back off my mouth after eating (looked like big blisters filled with fluid but never popped). Low blood pressure (99/65), low body temperature with chills (95.3F), dizzy on standing, blue finger tips loss of balance all lasting 1 day (most likely caused by mild reynod's). Subsided by day 17.
54 2021-04-08 pain in extremity Swelling of lips, tongue and neck within 15 minutes of injection. Was monitored for 30 minutes. Sw... Read more
Swelling of lips, tongue and neck within 15 minutes of injection. Was monitored for 30 minutes. Swelling did not progress and went down throughout the day. Lost sense of taste for a day. Arm became very sore the day after receiving injection. Felt like I had the flu in that one arm. Pain was a 7 on 1-10 pain scale with 10 being the worst. Arm continues to hurt from 3 inches above elbow up to shoulder joint to this day. After receiving 2nd shot in right arm on 01/09/2021, the left hurt worse than the right arm. The right arm did not hurt immediately after the shot like the left one did. I can pinpoint and place my finger on the place I received both injections still. Both continue to hurt in the same areas up my forearms.
54 2021-04-08 pain in extremity They began as red bumps on both arms when I woke up the following morning. The majority of the red ... Read more
They began as red bumps on both arms when I woke up the following morning. The majority of the red bumps/hives were on the left arm where I got the shot. The left arm was sore and slightly swollen. They bumps/hives became itchy and some spots spread and were raised up with a leathery appearance. I took Benedryl capsules for the first week, but became disoriented and dizzy, so stopped taking it. Used calamine and aloe vera as topical treatments. It is now 11 days from the first vaccine and I'm down to only 6 red hives on the left arm and 3 on the right arm. The right arm does have a large rash where I have scratched the hives and there is a quarter size rash has developed.
54 2021-04-08 pain in extremity 1st-day Extreme fatigue 2nd -day Left arm was sore couldn't lift it above my shoulder. 3rd-day Arm ... Read more
1st-day Extreme fatigue 2nd -day Left arm was sore couldn't lift it above my shoulder. 3rd-day Arm was the same and fatigue returned.
54 2021-04-08 tingling, numbness Patient received the first dose of Pfizer Covid-19 vaccine and about 5 minutes after complained of n... Read more
Patient received the first dose of Pfizer Covid-19 vaccine and about 5 minutes after complained of numbness and tingling in her face and felt her throat was closing up. Patient was medicated with 0.3mg epinephrine one dose, 911 called. EMS inserted IV line and Benadryl 50mg was administered once. The patient was transferred to the Emergency department where she was observed for 4 hours and given prescriptions for Prednisone and Benadryl for an additional 3 days on discharge.
54 2021-04-09 bell's palsy Bell's Palsy; This is a spontaneous report from a contactable other healthcare professional. A 54-ye... Read more
Bell's Palsy; This is a spontaneous report from a contactable other healthcare professional. A 54-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Feb2021 14:30 (Batch/Lot Number: EM9809) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine and sulfa drug allergy. Concomitant medications included hypericum perforatum (ST JOHNS WORT) taken for an unspecified indication, start and stop date were not reported; magnesium taken for an unspecified indication, start and stop date were not reported; and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient experienced bell's palsy on 20Mar2021. The outcome of events was not recovered. Therapeutic measures were taken as a result of bell's palsy.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event Bell's palsy due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-04-09 seizure Seizure
54 2021-04-10 numbness Numbness R face, observed, patron refused EMS
54 2021-04-10 numbness My mother got the vaccination on March 14 about a week later she started to feel numbness/pain from ... Read more
My mother got the vaccination on March 14 about a week later she started to feel numbness/pain from her toes to her stomach and on the back of my arm. She the second shot April 3, 2021. She went to the ER twice and was sent back home because they did not know what it was. Her doctor recommended cooper sock which didn?t work.
54 2021-04-11 weakness The day following the shot I slept excessively and despite taking extra strength Tylenol my headache... Read more
The day following the shot I slept excessively and despite taking extra strength Tylenol my headache never went away. My joints and muscles were very sore. No energy and difficulty concentrating. The second day was the same - sleeping most of the day with continuing headache and sore joints and muscles. The third day I did not go to work. Slight headache and body aches. New muscle pain across my chest when using my right arm (the arm of injection site).
54 2021-04-11 slurring, unresponsive to stimuli Stopped breathing while sleeping, my husband said I was snoring very loudly (which is not typical) a... Read more
Stopped breathing while sleeping, my husband said I was snoring very loudly (which is not typical) and I just stopped. He tried waking me and I didn't wake right away. He got up, turned on the light, noticed that I had wet the bed and he continued to shake me and called my name several times, then I opened my eyes. My speech was a bit slurred at first, I got out of bed, felt nauseous, and my ears were ringing very loudly. I sat up for a while, then went back to bed. I didn't connect it to the vaccine, but wondered about the connection. Then I heard it happened to someone else, so I thought I should report it. I did not seek medical care.
54 2021-04-11 facial paralysis, inability to speak Saturday March 13 Evening . Stroke symptoms, facial drooping, weakness in legs, difficulty walking, ... Read more
Saturday March 13 Evening . Stroke symptoms, facial drooping, weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. TPA administered. Situation resolved. Hospitalized 4 days. Note: My brother who resides in a different state suffered a stroke March 12. He also received the Pfizer vaccine date unknown.
54 2021-04-12 grand mal seizure neurological grand mal seizures; difficulty breathing; tight chest; sore achy bones, muscle; sore ac... Read more
neurological grand mal seizures; difficulty breathing; tight chest; sore achy bones, muscle; sore achy bones, muscle; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8737), via an unspecified route of administration at the left arm on 27Mar2021 12:45 pm at single dose for COVID-19 immunization. The patient's medical history included juvenile rheumatoid arthritis, asthma, diabetic Type 2, neurological seizure disorder from traumatic brain injury. The patient had known allergies to penicillin, tetracycline, sulfonamide. Concomitant medications included methotrexate (withheld for 2 weeks 25mg injection). On 28Mar2021 1:15 AM, the patient experienced neurological grand mal seizures, sore achy bones, muscle, tight chest, and difficulty breathing. The patient was treated with nebulizer for difficulty breathing. It was reported that patient had no covid prior vaccination nor tested post vaccination. Outcome of events was reported as not recovered.
54 2021-04-12 hot flush patient reports nausea, feeling hot/flushed.
54 2021-04-12 pain in extremity Hallucinations; Fever; Shaking chills; Headache; Bodyaches; Flu-like symptoms; Teeth chattering; Arm... Read more
Hallucinations; Fever; Shaking chills; Headache; Bodyaches; Flu-like symptoms; Teeth chattering; Arm soreness; Extreme nausea; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm, at age 54 years, on 26Mar2021 09:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Patient's medical history includes multiple sclerosis, hypothyroid, postconcussive syndrome and migraines from unspecified dates. The patient is not pregnant. Patient did not have other vaccine in four weeks. Patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. Patient previously took codeine for unspecified indication and had known allergies on an unspecified date, and other unspecified medications in two weeks. Patient historically took first dose of BNT162B2 (Product=COVID 19, Brand=Pfizer, administration time=05:00 PM, Vaccine location= Left arm) on 03Mar2021 at age 54 years for COVID-19 immunization. On 26Mar2021 20:00, 11 hours after vaccine administration, patient experienced fever, shaking chills, headache, hallucinations, body aches, flu-like symptoms, teeth chattering, arm soreness, extreme nausea. Therapeutic measures were taken as a result of these events which include paracetamol (TYLENOL). COVID was not tested post vaccination. Facility type of vaccine was at a public health clinic/veterans administration facility. The outcome of the events was recovering. Information on the lot/batch number has been requested.
54 2021-04-13 weakness No adverse events reported by patient to site staff. Pt reported a dry cough, tongue swelling sensat... Read more
No adverse events reported by patient to site staff. Pt reported a dry cough, tongue swelling sensation with mild dysphagia, anxiety and weakness 1 hour prior to ED presentation, roughly 1.5hours after shot provided, suggesting onset ~30 min after injection. Pt took chlorpheniramine with partial relief of symptoms.
54 2021-04-13 weakness Received the shot in my left arm on March 27, 2021. By 4:30 p.m., on March 28, 2021, I had a fever ... Read more
Received the shot in my left arm on March 27, 2021. By 4:30 p.m., on March 28, 2021, I had a fever of 102.4, aches, headache. March 29, 2021, woke up and took a shower and noticed my left lymph node was swollen (size of half a grapefruit. No pain or heat coming from the area. Was still swollen on March 30, 2021 and placed a call in for the doctor to contact me. The doctor contacted me on March 31, 2021 and I was placed on an antibiotic. The swelling went down in my lymph node in a few days from starting the antibiotic. I am still not feeling well, low energy and breathing is not right. Deep breaths are difficult and still have body aches.
54 2021-04-13 night sweats On March 10, I became covered in small itchy blisters over the right side of my entire body other t... Read more
On March 10, I became covered in small itchy blisters over the right side of my entire body other than my buttocks and stomach. On March 11, the rash had had spread to both sides; bruising began appearing on my joints, and large welts; the rash had gone from small blisters to inflamed welts. My wrist, knee, and ankles joints were aching and swelling. March 12, I went to the clinic. Initially, the PA said it looked like bed bug bites. I had an exterminator come to the house who definitely said there was no sign of bed bugs. (We have never had an infestation issue.) I went to Urgent Care on March 13, She said blisters were Shingles but pattern did not align but definitely viral infection. She put me on predinisone. I called the Clinic back. They had me come back in. I had to PAs and MD state same thing but could not diagnose. They added antiviral and hydrocortizone cream. I am scheduled for an appointment with my IOn days one and two, I had fever and chills and woke up in puddle of sweat. I woke up with a fever again March 14. Joint swelling and pain is worse. Fewer addtional blisters. I was also retested for Covid - came back negative. I go to PCP tomorrow.
54 2021-04-13 pain in extremity At site location ; COVID19 Vaccination, 1st shot light headache for a day. second shot symptoms of m... Read more
At site location ; COVID19 Vaccination, 1st shot light headache for a day. second shot symptoms of mild headache for 2-3 days, right arm sore for a few days, both feets swollen with red rashes top of both foots. (right top foot darker rash). Still have swelling on both foot.
54 2021-04-13 pain in extremity Severe pain in left shoulder starting in March. Progressed to right shoulder, then to wrist and knee... Read more
Severe pain in left shoulder starting in March. Progressed to right shoulder, then to wrist and knee. Been to urgent care twice for medical assistance. Pain levels vary from 5-10 depending on movement and has not fully resolved.
54 2021-04-13 tingling Received her first dose of the COVID vaccine (Pfizer LOT#: EW0161 Exp: 7/2021) at 1057. Patient aler... Read more
Received her first dose of the COVID vaccine (Pfizer LOT#: EW0161 Exp: 7/2021) at 1057. Patient alerted EMT. Patient stated that she felt a tingly feeling on her right chest/ breast area. EMT alerted. Asked patient to stay 30 more minutes for further observation. Patient agreed. BP: 106/62, pulse: 67, 02: 99%. Patient stated that she has been diagnosed with anxiety. After 30 minutes of observation patient stated that she was feeling much better and that the tingly feeling went away. Patient left with her friend and walked out of vaccination site with a steady gait.
54 2021-04-13 unresponsive to stimuli Patient reported feeling ''weird''/lightheaded and seeing green dots. Patient was placed in a wheelc... Read more
Patient reported feeling ''weird''/lightheaded and seeing green dots. Patient was placed in a wheelchair and brought to a private observation area. On arrival patient was unresponsive and drooling. EMS was notified. Upon EMS arrival patient became arousable and was talking without difficulty. Vitals and telemetry wnl. Patient reported a similar syncopal episode with blood draw in the past. Patient was stable AAO x3. Patient agreed to have a friend drive her home, f/u with PCM if recurrent symptoms, and ER if new or worsening symptoms.
54 2021-04-14 numbness Got the vaccine, shortly after that had a feeling of having a novocaine shot numbing feeling from he... Read more
Got the vaccine, shortly after that had a feeling of having a novocaine shot numbing feeling from her right side of her arm, her shoulders, head/neck, and then to the left arm. This then passed. That evening she was tired, sleepy and then the next day she had a bad headache. (possibly related to menstrual cycle beginning). She took Excedrin for that and when she woke up the 2nd day she was fine. Then on 4/12/21 she had her hair pulled up and reached the back of her neck and felt a pimple like feeling on the back of her neck. She then had her daughter look at her neck who informed her that she had a red rash, squeezed it and it popped and then noticed she had several on her neck. She then had the numbness return that she had on the right hand side of her face, her arm and a little down her leg. She went and got some Vitamin E ointment and rubbed it on the back of her neck, which seemed to resolve the rash eventually. Then that numbness feeling went away within an hour or two. The following night she also had recurrence of the same events from the previous day. Last night 4/14/21, she had the rash again on the back of her neck, and had actually moved down into her back area, down to her shoulder blade the same pimply type rash, and numbness down her side. She now has the same feeling around her ear area. She tried again the vitamin E ointment which did not help anything. She then took a Vitamin D pill which did not seem to do anything either. She woke up multiple times during the night as she still had the feeling and did not go away. When she woke up she felt sort of okay, has the rash, had the feeling of having had a headache/achy feeling, and can feel the rash on the back of her neck again. She has a call into her doctor to see if she can be seen. She has also noticed that her right arm had some swelling around the elbow area, but last night's episode she could definitely tell that it was swollen and the skin tight in the upper inside of the elbow and up to about the armpit.
54 2021-04-14 muscle spasms Patient complained of muscle aches and cramping in bilateral arms, legs and left side. She states sh... Read more
Patient complained of muscle aches and cramping in bilateral arms, legs and left side. She states she is well hydrated and has not experienced muscle cramping in the past, has no known other causes of these symptoms.
54 2021-04-14 muscle spasms 5 days later I got a headache and then next morning a fever, terrible body aches, cramping, diarrhea... Read more
5 days later I got a headache and then next morning a fever, terrible body aches, cramping, diarrhea, elevated heart rate, worse on day 6 and 7, went to ER still sick but a bit better
54 2021-04-14 pain in extremity The next morning my arm was sore and I felt tired About 24 hours later my entire body ached terribl... Read more
The next morning my arm was sore and I felt tired About 24 hours later my entire body ached terribly and I needed to lay down. I slept 10 hours. today April 15, I feel better no aching not tired.
54 2021-04-14 tremor Systemic: Allergic: Anaphylaxis-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Addi... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Additional Details: temp within normal range, BP 149, 146, then 161. had a fast heartbeat so drink 2 small water bottle and shaking hands a liitle.\r\npharmay monitored her more than 1 hour and 30 minutes. she is ok to go home. (previous event happened on last december d/t epinephrine inj at dental office)
54 2021-04-15 involuntary muscle movements, muscle spasms, tremor Brain fog, difficulty sustaining thought -- began 72 hours after first Pfizer COVID shot and continu... Read more
Brain fog, difficulty sustaining thought -- began 72 hours after first Pfizer COVID shot and continuing to current day (2 weeks after first shot) Jelly legs -- began 72 hours after first shot; replaced by muscle spasms described below. Brain "shaking" -- began 96 hours after first shot and continuing to current day (2 weeks after first shot) Muscle spasms -- began 96 hours after first shot and continually worsening to current day (2 weeks after first shot). Began with slight head and shoulder jerks; progressed to also include leg, arm, ankle, and wrist spasms and numbness in toes. Extreme insomnia -- brain shaking and muscle spasms prevent sleep. Have slept a total of 22 hours in the last 240 hours.
54 2021-04-15 feeling cold Vaccine was given at 840am on 4/14/2021. Felt fine during the day. Slept for a few hours. At 1a wo... Read more
Vaccine was given at 840am on 4/14/2021. Felt fine during the day. Slept for a few hours. At 1a woke up to fever, chills, headache, joint soreness, sweating, then freezing. I took tylenol throughout the following day but it barely made it the symptoms go away. Symptoms continued until 9pm 4/15/2021. 4/16/2021 - continued muscle soreness and headache but fever has subsided.
54 2021-04-15 feeling of body temperature change Headache Hot and cold, with temp of 100 degrees Severe joint paint Could not sleep
54 2021-04-15 hot flush I received both doses if my Pfizer vaccine, last dose on 3/26. I have been having terrible hotflashe... Read more
I received both doses if my Pfizer vaccine, last dose on 3/26. I have been having terrible hotflashes since the first dose. I am post menopausal and have not had any heat flashes for almost a year until now. Is this common and how do i stop them?
54 2021-04-15 muscle spasms, migraine, breast pain, pain in extremity Immediately upon the injection I felt the cold going down my arm and then it was burning like on fi... Read more
Immediately upon the injection I felt the cold going down my arm and then it was burning like on fire. That last intensely for several hours. Within minutes of the injection I had a migraine headache, pain in my calf that was like an intense charlie horse (this lasted into the next evening then over a day was much less), and I had extreme pain in my breasts. That pain lasted about 3 days.
54 2021-04-15 pain in extremity Chills soreness in arm tired
54 2021-04-15 pain in extremity woke about 5am day after receiving 2nd shot with pain at injection site, headache, swelling /pain un... Read more
woke about 5am day after receiving 2nd shot with pain at injection site, headache, swelling /pain under left arm, pain/ache in left leg, and redness and hardness around injection site. I took two doses of aspirin and one dose of cold & flu medicine during the day (4/7) and one dose of liquid cold & flu medicine before bedtime. 4/8 - fever and headache gone, still have the rest of the side effects, took aspirin at bedtime for leg pain. 4/9 - still have rest of side effects, took aspirin at bedtime for leg pain. 4/10 -4/12 - leg pain gone, still mild pain at injection site and underarm still swollen with mild pain. 4/13 - all side effects gone.
54 2021-04-15 tingling Client had 2nd dose of COVID vaccine, ten minutes later reported her fingers felt tingly. Vital sig... Read more
Client had 2nd dose of COVID vaccine, ten minutes later reported her fingers felt tingly. Vital signs stable, denies any other symptom. "Tingling sensation" resolved 15 minutes later, client able to go home.
54 2021-04-16 cold sweat, discomfort Pfizer-BioNTech COVID-19 Vaccine EUA, beginning on 3/17/2021 I began to feel fatigued and my legs fe... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA, beginning on 3/17/2021 I began to feel fatigued and my legs felt tired and heavy and I had headaches and felt light-headed, then on 3/25/2021 I developed a fever of 102 degrees and had chills and my whole body ached, I contacted my doctor who sent me to the ER for evaluation, the ER tested me for COVID-19, and Influenza type A and B and I was found negative on these tests, they sent me home and instructed me to take Tylenol, drink fluids and relax and follow up with my doctor, I spoke to my doctor the next day and he told me that I was most likely having a long term reaction to the vaccine, I began to feel some better and went back to work but on my first day back 4/5/2021 I started to feel bad again, I told my manager who sent me to the company OHS where I was told I had to do a physical which included lifting 50 pound and carrying it around many times this made me feel even worse, they sent me home for three days. I went for second dose on 4/7/2021 and was feeling some better so I went back to work on 4/12/2021 however since then I have still been experiencing symptoms such as: first, heaviness in my forehead which has now spread to my whole face and I continue to have occasional chills and light-headedness also since doing the lifting of the 50 pounds during the physical I have occasional aching in my abdomen and I'm having cold sweats and don't feel myself.
54 2021-04-16 involuntary muscle movements A family member of the patient state the she felt heavy tongue immediately after getting the shot. ... Read more
A family member of the patient state the she felt heavy tongue immediately after getting the shot. Later the patient started to have trouble breathing and difficulty swallowing. A family member reported that the patient have involuntary movements . nThe patient was given first aid and is transported to the ER
54 2021-04-16 pain in extremity I had the 2nd vaccine on Thursday afternoon. My arm was sore but that was it. Then I woke up in mi... Read more
I had the 2nd vaccine on Thursday afternoon. My arm was sore but that was it. Then I woke up in middle of the night (3:00 am) Friday night/Saturday morning and noticed an itchy spot that felt like a mosquito bite. I went back to sleep and when I got up around 7 I was itchy in several spots and had welts. I had them on my left hip and part of stomach, on the right side under bra band, my left thigh, and my right arm. it is not where the shot was, it is under part of arm from underarm to almost my elbow. These all started about quarter size and are now as big as my hand or bigger. One also came up on top of left shoulder but it is still small, that one just came up around 7 pm. And my lip swelled up a little around 5 pm but just on one side of top lip. All of these welts are very itchy.
54 2021-04-16 tingling, numbness, pain in extremity 20 minutes after the vaccine my muscles started to become weak and painful. Throughout that day the ... Read more
20 minutes after the vaccine my muscles started to become weak and painful. Throughout that day the pain, muscle weakness, fatigue, lethargy increased then the next morning I was not able to function. This NEVER went away. The pain in every muscle and joint has been so severe and debilitating as well as the fatigue and lethargy. It has been 7 weeks and I am still suffering severely. I have been on high doses of Ibuprofen first(by my doctor) and then high doses of Prednisone by my doctor which I have not been able to come off of. The pain is in all four extremities, shoulders, low back, and hips and is a joint pain, muscle pain, and a severe burning pain. I continue to be lethargic and fatigued unable to get through my work day and needing to lie down often. I was a very fit, active person and now cannot do any activities due to the pain and lethargy. My joints will also give out when I walk including my hips, knees, and ankles. There is numbness and tingling in my extremities, but more in the right arm and right leg. It will feel like there is a tourniquet around them cutting off all circulation.
54 2021-04-17 burning sensation, tingling Within 5 minutes of administration experienced metallic taste. followed by limp and facial tingle an... Read more
Within 5 minutes of administration experienced metallic taste. followed by limp and facial tingle and burn. Did not progress for the 15 min watch time. stopped at store and started having tongue and soft palate swelling and burning. Had taken zrtec in am for seasonal allergies . Went home and took 50 mg of benadryl . No hives, itching on face and neck only ( mild). Reaction did not progress.
54 2021-04-17 pain in extremity bad headache; made her really tired; arm got sore; This is a spontaneous report from a contactable c... Read more
bad headache; made her really tired; arm got sore; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021), dose 1, via an unspecified route of administration on 02Mar2021 (at the age of 54-years-old) as a single dose for covid-19 immunisation. Medical history included borderline high blood pressure from an unknown date and unknown if ongoing, heart flutter from an unknown date and unknown if ongoing and covid-19 from an unspecified date in Nov2020. Concomitant medication(s) included verapamil (VERAPAMIL) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication from 2020. On 02Mar2021, the patient experienced a bad headache, it made her really tired and then her arm got sore. When she arrived home after receiving the vaccination, she took Tylenol and had to lay down. Therapeutic measures included Tylenol. Clinical outcome of the events bad headache, made her really tired and her arm got sore was resolving. No follow up attempts are needed. No further information is expected.
54 2021-04-18 feeling hot, difficulty speaking, feeling cold Her account of what happened: ?I HAD MY COVID VACCINAE AT APPROXIMATELY 3:50 P.M. AND SHOFTLY AFTER ... Read more
Her account of what happened: ?I HAD MY COVID VACCINAE AT APPROXIMATELY 3:50 P.M. AND SHOFTLY AFTER THE VACCINE I STARTED TO FEEL HOT AND THOUGHT I WAS GOING TO PASS OUT, SO I ASKED IF THERE WAS SOMEWHERE I COULD LAY DOWN, I WA GIVEN SOME WATER AND A SNACK IF NEEDED. THE NURSES CHECKED MY BP AND IT WAS ELEVATED 150/100. I THEN DEVELOPED CHEST HEAVINESS AND THEN BP WENT HIGHTER. CHEST HEAVINESS SUBSIDED BUT THEN DEVELOPED A HEADACHE, BP CHECKED AGAIN AND WAS UP TO 160ISH/100, I ASKED FOR SOME TYLENOL AND TOOK 650 MG, I WAS OFFERED BENADRYL AND DECLINED. THE THE BACK OF MY THROAT STARTED TO FEEL STRANGE AND I COULD NOT MAKE A SWALLOW SENSATION UNLESS I TOOK A DRINK OF WATER. I THEN ASKED FOR THE BENADRYL AND TOOK IT. MY BP WAS THEN UP TO 180ISH/112 AND I THEN STARTED TO FEEL COLD AND HAD CHILLS. AT THE TIME AN ACT WAS CALLED AND I WAS TAKEN TO THE ER AND PLACED IN TRIAGE THEN THE WAITING ROOM. THEN WAS FINALLY TAKEN BACK TO THE ER AND WAS GIVEN IVF'S, IV BENADRYL,PEPCID AND PREDNISONE WITH RESOLUTION OF SYMPTOMS AND DISCHARGED HOME WITH 2 DAYS OF STEROIDS AND PEPCI, BENADRYL. HIGH BP CHILLS CHEST HEAVINESS HARD TO SWALLOW HOARSENESS?
54 2021-04-18 pain in extremity, feeling cold I started hurting with just my arm really bad, than, later like at 5pm I started feeling more sick ... Read more
I started hurting with just my arm really bad, than, later like at 5pm I started feeling more sick like a headache than at 7:30pm I started with chills hot, like a fever and body ache and really bad all night like when I was sick from Covid-19. I had Covid in January 13th 2021, and came negative in January 31st 2021. I still feel very sick I have been with a headache all day and right now I feel nauseas, and today is 4-18-2021 and its 11:42 pm I also have a big headache. I started taking Tylenol 500mg and I'm still taking Tylenol 500mg and Advil 200mg
54 2021-04-18 pain in extremity Sore shoulder at the injection site but days later that subsided. In the next few weeks pain radiate... Read more
Sore shoulder at the injection site but days later that subsided. In the next few weeks pain radiated to my left elbow, upper back and neck all on the side of the injection. This continued for weeks. I had two massages to get the toxins circulating again and it has now subsided (3 weeks later)
54 2021-04-18 pain in extremity as soon as injection was made, it felt like liquid shooting up my neck. I had the usual arm pain, f... Read more
as soon as injection was made, it felt like liquid shooting up my neck. I had the usual arm pain, fatigue, fever, lasting about 24 hours. For next 11 days I was sick to stomach with very mild fever that would come and go, but nothing unbearable. On about day 13 after vaccination, I had a sharp, pulsating pain in the injection site. pulsated for about 5 min, then stopped. Over the next week, at random times, I feel pain in the injection site, not my whole arm, and feverish off and on. I have the stomach discomfort off and on as well. I have had many injections in my life and have never felt liquid run up my neck. Did it go into a vein? Is the vaccination as effective? Why am I continuing to have pain?
54 2021-04-19 weakness Fatigue set in about 11 hours after I was given the shot on Sunday, but it was bedtime so I didn't t... Read more
Fatigue set in about 11 hours after I was given the shot on Sunday, but it was bedtime so I didn't think much of it. At 1:15 am, I woke to violent shaking all over, and all-over achiness but no fever. I took one 500 mg Tylenol, and slept fitfully, I felt like I was aware that I was extremely uncomfortable, and I was either too cold or too hot. My temperature fluctuated from normal to about 100.8, on and off all the next day. It was an extreme effort and it was difficult to even shift my body position in bed, and my arm that was vaccinated could barely move and it hurt tremendously. My head ached, and my lower back ached the most, aside from my arm. I slept nearly all day yesterday (Monday), and I was very weak, with hardly any appetite. It took all effort to get out of bed to use the bathroom. I took a Tylenol 500 mg pill every 5-6 hours and those first couple hours felt the most pain relief. I counted down the time to get past 5 hours to take another one. Around 7 pm, after sleeping all day, I got out of bed to sit upright on the couch to relieve my back pain, and that helped. Symptoms started easing up later last night. I slept more than 9 hours again and today am feeling weak but no body aches or headache, only my arm is sore but not as bad as it was yesterday. I am less fatigued today but moving slowly, and my appetite is slowly returning. I have avoided taking more Tylenol since bedtime last night and feel like the worst is behind me. I hope.
54 2021-04-19 weakness Immediate weakness after shot. Numbness in arm. Approximately 1 hour later face has a few Hives. F... Read more
Immediate weakness after shot. Numbness in arm. Approximately 1 hour later face has a few Hives. Face and neck are itchy.
54 2021-04-19 migraine SEVERE JOINT PAIN THE DAY AFTER INJECTION, MIGRAINE BEGINNING THE DAY AFTER INJECTION LASTING 4 DA... Read more
SEVERE JOINT PAIN THE DAY AFTER INJECTION, MIGRAINE BEGINNING THE DAY AFTER INJECTION LASTING 4 DAYS, JOINT PAIN CONTINUED FOR 7 DAYS FOLLOWING INJECTIONCONTINUES TO HAVE INTERMITTENT HEADACHE
54 2021-04-19 pain in extremity Tongue swelled. I was able to take Benedryl every 4 hours for the next 24 hours. Headache, tired, ... Read more
Tongue swelled. I was able to take Benedryl every 4 hours for the next 24 hours. Headache, tired, and sore arm.
54 2021-04-19 pain in extremity Day 2 arm aches. On Monday the 19th HA, Backache and increase in O2 needs cannot keep O2 above 77% w... Read more
Day 2 arm aches. On Monday the 19th HA, Backache and increase in O2 needs cannot keep O2 above 77% without oxygen being administered, .overnight O2 dipped to 55%. However is also on new meds from her pulmonologist which may be a factor.
54 2021-04-20 discomfort I developed loud tinnitus in both ears the day after receiving the vaccine. It is very uncomfortable... Read more
I developed loud tinnitus in both ears the day after receiving the vaccine. It is very uncomfortable. I never had this before. I also feel dizzy like vertigo or the flu. I had severe flu symptoms for six days afterwards. I still get waves of flu symptoms.
54 2021-04-20 feeling hot, pain in extremity, tingling My upper/mid left arm, is very swollen. It has been since the day I received the vaccine-happened al... Read more
My upper/mid left arm, is very swollen. It has been since the day I received the vaccine-happened almost immediately. My arm is also very painful, tingly, all the way down to the fingers. This swelling and pain has not subsided at all, since I received the vaccine. I went to the hospital the same evening. I was given an antihistamine, Ibuprofen, and ice, and told there was nothing more they knew to do. A week later, I went to my former family physician, and was given an antibiotic for a week. (do not remember the name). Nothing changed after a week so on Tuesday, April 20, I went to the ER. They gave me a test to check for a blood clot, as well as a Percocet pill and an hour after a shot of Morphine. There was not evidence of a blood clot, and I came home. There is still swelling today, though now I have a course of Wal-Dryl, 25 mg Allergy caps , 24 pills. 1 every 4 hours, a course of Prednisone, 20 mg, 20 pills, and oxycodone/Acetaminophren 5-325 mgs for pain, 18 caps, 1 every 4 hours. I have also called the County Health Department who advised to see an Infectious Disease Doc. I am still in pain, and swollen. I haven't had a fever, but am feeling warm, tired and achy.
54 2021-04-20 feeling hot Patient is 54 y.o. year-old female status post receipt of second dose of Pfizer Covid vaccine. Patie... Read more
Patient is 54 y.o. year-old female status post receipt of second dose of Pfizer Covid vaccine. Patient was in observation after the vaccination. Observation area staff informed that patient is feeling " sweaty". Pt was able to walk to triage room adjacent to observation area. Patient is assisted to sit in recliner with legs elevated. She c/o feeling hot and diaphoretic. Denies dizziness, chest pain, shortness of breath or palpitation. Patient reported that she did fine with the first dose of the vaccine and did not feel sweaty of hot. PMH significant for pre-diabetes ( on victoza) and GERD. Denies any cardiac hx. BP 116/60, HR 46, RR 14, O2sat 97%. On pulse ox monitor HR ranges from 30's to 70's, intermittently to 20's. Blood sugar 87. Assessment & Plan: Patient status post receipt of second dose of Pfizer Covid Vaccine with c/o feeling sweaty and hot. She had no other complaints. Diaphoresis resolved within 20 minutes. Patient reported that she is feeling better and not feeling hot any more. She drank water and ate Graham crackers. Monitored for 30 minutes. Pulse rate continues to range from 30's to 70's and intermittently to 20's. However, she was asymptomatic without any chest pain, palpitations or dizziness. No signs/sx of acute allergic reactions like hives, rashes, SOB, wheezing, cough, angioedema, GI symptoms or hypotension/tachycardia noted. Given the irregular heart rate and pulse rate dropping to 30's intermittently 911 is called who arrived and assessed patient. She is transported to hospital via stretcher by emegency personnel for further evaluation.
54 2021-04-20 numbness, tingling I experienced after my second dose, left side of my face and ear went numb and tingly. I had funny ... Read more
I experienced after my second dose, left side of my face and ear went numb and tingly. I had funny taste to my stomach and felt nauseated. I looked like Bell's palsy syndrome. I went to the ER, they gave me steroid medication. I experienced after my first dose, I had numbness and tingling sensation on my left side of m face, had a metallic taste and when i would eat I would get nauseated, like I was going to throw up, my tongue felt funny, strange only on my left side. I had lob work done for my thyroid, I had a Covid-19 test which was negative. These symptoms lasted abut four days before my second dose.
54 2021-04-20 migraine Shot 2, increased my blood pressure and gave me migraine headache. Side effects not listed on site.
54 2021-04-20 pain in extremity, burning sensation, discomfort I did not see or feel the pharmacist insert a needle into my arm. What I saw was a square little box... Read more
I did not see or feel the pharmacist insert a needle into my arm. What I saw was a square little box pressed against my skin and then she said it was done. I felt absolutely nothing and was surprised that the injection had been administered. The day after I felt all right just a very sore arm. But the following day some side effects started occurring which still have not gone away after three weeks. Severe fatigue not able to function at normal level, exercise I can only do about a third what I usually do. Brain fog. Listlessness. All muscles and joints achy and burning all of the time, skin flaring up red, sensation of systemic inflammation. Tremendous water retention, picked up about 7 pounds without any dietary change. Urination is scant even though I drink about 64 ounces of water a day. Stool is a lot less than it used to be, and I?m usually very regular . I wake up very groggy and tired in the morning. Very heavy sensation in the body. What I should mention is that I was about 80 pounds overweight and tests showed heightened inflammation markers two years ago. Since then I lost about 30 pounds on a high-protein diet with 4 to 5 times a week exercising and strength training. The heightened inflammation disappeared as well as the chronic tinnitus in 2018. . Two days after I had the vaccine, all my inflammation symptoms tinnitus, water retention and weight gain returned, despite no change to my diet or exercise regime.
54 2021-04-20 pain in extremity, burning sensation, cold extremities, tingling On Tues, April 20, I began to get an tingle/itch all over my body. By 9:30pm, both of my legs and fe... Read more
On Tues, April 20, I began to get an tingle/itch all over my body. By 9:30pm, both of my legs and feet began to tingle, ache, and have a burning sensation, but they were cold to the touch. This intense sensation continued throughout the day on Wednesday, April 21. I visited urgent care on Wednesday at 2:45pm. After the physical exam, the PA could not find any life-threatening symptoms (Temperature 97.3 degrees, BP 174/84, pulse 88, strong pulse in both feet) and I was instructed to return home and take Aleve. It is 11:30pm on Wednesday, April 21 and the burning, tingling, and pain has not subsided even after taking the Aleve. I don?t what to do because the sensation will not go away.
54 2021-04-20 pain in extremity, feeling cold pt says she got very woozy and waited 15 minutes before leaving after taking the vax. She ran erran... Read more
pt says she got very woozy and waited 15 minutes before leaving after taking the vax. She ran errands and then went home but still felt woozy. She took an aspirin and went to bed. She woke up with pain in her bones. She said the pain from her neck down to her feet. She had pain her her right arm, nauseated, head pressure, still neck, light headed, and cold. She took aspirin for her symptoms that lasted for 5 days. On the 6th day her neck was still stiff so she took aspirin and went back to work. Her symptoms have since subsided.
54 2021-04-20 tremor Patient received vaccine and reported a feeling of chest discomfort, dizziness, and shakiness. BP 1... Read more
Patient received vaccine and reported a feeling of chest discomfort, dizziness, and shakiness. BP 138/84 HR 101 O2 sat 100%. 11:25 am BP 137/77 HR 105 O2 Sat 100. Patient continues to report chest discomfort. 11:34 Given Allegra. 60 mg PO. 11:39 152/77 HR 108 O2 Sat 100% Patient states that she still has numbness in her mouth and jaw. Her chest discomfort is better. She is requesting to be evaluated at the ER. Squad was called. 11:43 Squad arrived and patient taken to hospital.
54 2021-04-21 feeling hot Patient here for second dose COVID-19 Pfizer Vaccine. At the time of vaccination, patient reported e... Read more
Patient here for second dose COVID-19 Pfizer Vaccine. At the time of vaccination, patient reported experiencing nausea approximately two hours after first dose. Patient was advised to report symptoms to the observer in observation area. After approximately 20 minutes, patient stated that she was not feeling better. Nurse brought patient back to recovery room. Nurse took patient's vitals q15minX3. Patient stated that blood pressure was elevated from her baseline. Patient also stated that she felt warm and nurse gave her an ice pack. Patient reported that her husband was coming to transport her home. Patient advised of emergent symptoms and to report to Urgent Care or ED if symptoms worsened. Patient informed that an incident would be filed with VAERS and that she may be contacted.
54 2021-04-21 migraine I got the first dose of the Pfizer vaccine on 04/12/2021 and started getting severe migraine headach... Read more
I got the first dose of the Pfizer vaccine on 04/12/2021 and started getting severe migraine headaches on the left side of my head. The headaches are throbbing and continuous. On a pain scale of 10/10. I used Tylenol 1000 mg alternated with Ibuprofen 400 mg every 6 hours with very minor relief. I started using over the counter migraine medication (combo acetaminophen 250 mg, Aspirin 250 mg and Caffeine 65 mg per tab) I have been taking 2 tablets a day starting 4/20/21 with some relief, pain scale is still 5-6/10.
54 2021-04-21 pain in extremity Sore arm for a week. Fever of 102 l, chills and aches and nausea began roughly 15 hours later and la... Read more
Sore arm for a week. Fever of 102 l, chills and aches and nausea began roughly 15 hours later and lasted for roughly another 15 hours.
54 2021-04-22 numbness, pain in extremity Sore arm at 8 hours after Big welt in inside elbow of same arm (left) at 9 hours Tight and significa... Read more
Sore arm at 8 hours after Big welt in inside elbow of same arm (left) at 9 hours Tight and significant numbness in fight leg and foot at 12 hours 99.1 fever at 18 -22 hours after Body aches and fatigue 18-24 hours
54 2021-04-22 migraine, cold extremities, feeling cold, hot flush, tingling Severely Cold 15-20 minutes after shot. Last 12 hours. Had to turn heat up to 75 & wear a sweatshirt... Read more
Severely Cold 15-20 minutes after shot. Last 12 hours. Had to turn heat up to 75 & wear a sweatshirt to stay warm. Hands felt like ice. Then sever Migraine headache for 6 days. Took Imitrex those days & Excedrin the 7th day(today). It also feels like menopause is back. Get hot flashes but tingly (needle Like)
54 2021-04-22 tingling Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/12021 at Park. She developed itching and t... Read more
Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/12021 at Park. She developed itching and tingling of her hand. She was evaluated and given Pepcid 20 mg x1. She was observed for 30 min and sent home.
54 2021-04-23 numbness, tingling Tingling and numbness down the fronts/shins of my lower legs down to the tops of my feet, very notic... Read more
Tingling and numbness down the fronts/shins of my lower legs down to the tops of my feet, very noticeable when sitting but not when walking, and tingling and numbness in forearms and hands noticeable when sitting and lying down. Symptoms appeared after first shot. Symptoms greatly intensified right after second shot, then dropped down again to same level as after first shot.
54 2021-04-24 weakness severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating ... Read more
severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating pain into the right arm and lymp nodes; blood pressure was through the rood; severe pain; cardiac issues; GI issues/GI malfunction of the pancreas and gallbladder; GI issues/GI malfunction of the pancreas and gallbladder; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 09:45 (Batch/Lot Number: Unknown reported as either EN6205 or EM6205) as SINGLE DOSE for COVID-19 immunization; azithromycin (ZITHROMAX), via an unspecified route of administration from 26Feb2021 until 02Mar2021, at unspecified dose and frequency for dental care; and corticosteroid (CORTICOSTEROID), via an unspecified route of administration from an unspecified date with last dose shot on 23Mar2021 at unknown dose, once or twice a year for a couple of years for knee pain and joint pain . Medical history included dental procedure on an unknown date. Concomitant medications were not reported. On 25Mar2021 (9 days later), she developed severe chest pain like severe heart burn attack radiating pain into the right arm and lymph nodes, blood pressure was through the roof and was in severe pain. She was unable to eat, was very weak and also cannot work or engage in daily activities noted in Mar2021. The patient required emergency room and physician office visit due the events (including cardiac issue and GI issues/malfunction of the pancreas and gallbladder). She was hospitalized on 03Apr2021 and was just released on 04Apr2021. During hospitalization, doctors have ruled out cardiac issue and GI issues/malfunction of the pancreas and gallbladder and they cannot find out the cause. The patient received famotidine (PEPCID), omeprazole (PRILOSEC), pantoprazole (PROTONIX), acetaminophen (TYLENOL) as treatment. While in the hospital they gave her dicycloverine (BENTYL) which she thought was for nausea noted in 2021.She stated a week after she got the vaccine she got a corticosteroid shot which she was wondering if it can impact one's immune system and cause an adverse reaction with the vaccine. She also stated that a month prior to vaccine she took an azithromycin. She also was wondering with the combination of all these three things being close together if it may have caused a disruption in her body organic system. The action taken in response with the adverse event for azithromycin was post therapy while unknown for corticosteroid shot. The patient did not recover from chest pain while outcome of the remaining events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021376222 Pfizer
54 2021-04-24 facial pain cheeks, chin and marionette lines/ swelling; bruising; cheeks, chin and marionette lines/ pain; chee... Read more
cheeks, chin and marionette lines/ swelling; bruising; cheeks, chin and marionette lines/ pain; cheeks, chin and marionette lines/ pain; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Mar2021 at single dose for COVID-19 immunization, started to receive hyaluronic acid, lidocaine (RESTYLANE L) from 23Mar2021 for unspecified indication. Medical history was not provided. Concomitant medications were not provided. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Patient injected to cheeks, chin and marionette lines with hyaluronic acid, lidocaine on 23Mar2021 and experienced swelling, bruising, and pain in Mar2021. Patient took Arnica, ibuprofen and applied ice; bruising resolved, other events were ongoing. Action taken with hyaluronic acid, lidocaine was unknown. Outcome of the event bruising was recovered while other events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
54 2021-04-24 feeling of body temperature change, weakness Severe headache/centered in forehead radiating slightly back; I couldn't eat due to nausea and minor... Read more
Severe headache/centered in forehead radiating slightly back; I couldn't eat due to nausea and minor vomiting in first half of the day; I couldn't eat due to nausea and minor vomiting in first half of the day; couldn't eat due to feeling weak and lightheaded; couldn't eat due to feeling weak and lightheaded; I was hot and cold throughout the day; Unable to locate thermometer to take temperature; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered on left arm 25Feb2021 02:00 PM at single dose for COVID-19 immunisation. Patient medical history included asplenic, cochlear implant, survived bacterial meningitis, PTSD, anxiety, depression, neck and back pain and allergies. Allergies to medications, food, or other products: Bactrim. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination: Tizanidine, clonazepam, Lamictal and singular. On 26Feb2021 11:00 AM, the patient had experienced severe headache centered in forehead radiating slightly back Ice on patient's head made the headache worse Tylenol helped a bit, couldn't eat due to nausea, minor vomiting, feeling weak and lightheaded, hot and cold throughout the day. Unable to locate thermometer to take temperature and visual impartment. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of event is Recovering. Information on the lot/batch number has been requested.
54 2021-04-24 numbness 4/20/21: Got the shot on Tuesday 4/20/21 at 9.35 am. felt a little light headed and my right hand fe... Read more
4/20/21: Got the shot on Tuesday 4/20/21 at 9.35 am. felt a little light headed and my right hand felt a little numb right after the shot. went away but rest of the day felt tired. 4/21/21: 11 am got a fever of 99.8. i usually run about 97.1 4/22/21 - ok in the morning. starting the afternoon felt very dizzy and fever came back. slept the rest of the day. 4/23/21 - still felt dizzy. rested all day 4/24/21: started feeling better. by 4/25/21 I felt fine.
54 2021-04-24 numbness and pain in extremities, pain in extremity, sensory loss Diagnosed radial nerve inflammation in the left arm.; radiating pain throughout the lower left arm; ... Read more
Diagnosed radial nerve inflammation in the left arm.; radiating pain throughout the lower left arm; some loss of sensation is also present in the index finger of the left arm; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 54 years, via an unspecified route of administration, administered in Arm Left on 10Feb2021 08:00 (Batch/Lot Number: EL9265; Expiration Date: May2021) as a single dose for covid-19 immunization. The patient's medical history included fibromyalgia like symptoms localized just to the right side of body. Concomitant medication included levocetirizine (LEVOCETIRIZINE) taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient experienced diagnosed radial nerve inflammation in the left arm, radiating pain throughout the lower left arm, some loss of sensation is also present in the index finger of the left arm on 01Mar2021. It was further reported that the patient was diagnosed with radial nerve inflammation in the left arm. Pain occurred two weeks after vaccination and continues up to today despite multiple medications (steroids and anti-inflammatory) tried over the last two months. In addition to radiating pain throughout the lower left arm, some loss of sensation was also present in the index finger of the left arm. The patient underwent lab tests and procedures which included nasal Swab on 24Mar2021 and 06Apr2021 which were both negative. Therapeutic measures were taken as a result of the events included Prednisone, Zorvolex and Tizanidine and Dexamethason. The outcome of the event was not recovered.
54 2021-04-24 pain in extremity, discomfort she woke up feeling like she was getting a cold; shivering; sweating; running a fever; feel uncomfor... Read more
she woke up feeling like she was getting a cold; shivering; sweating; running a fever; feel uncomfortable; armpit swelling and soreness; armpit swelling and soreness; arm being sore; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left (left upper arm, near the top of her shoulder) on 06Apr2021 14:00 (Batch/Lot Number: EW0151) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Her arm started to feel sore immediately after getting the vaccine on 06Apr2021. It stated that as the day went on, the soreness was getting more pronounced. When the syringe went in, she felt it, like it had crossed the cartilage or something. A few hours after that, the soreness was settling in and it was getting more sore. By the end of the day, it was more sore. Her arm was sore most of the day yesterday (07Apr2021) and was uncomfortable. Her arm is still sore today (08Apr2021) but not as bad as it was. Wednesday morning, yesterday, she woke up feeling like she was getting a cold, she was shivering. Yesterday, she spent the whole day in bed, shivering, and sweating, and running a fever. By the time she got to bed, she was feeling a little better so she thought she would be feeling better this morning. Her fever started yesterday mid-morning around 9:30 or 10:00 am. The fever lasted the whole day and subsided in the evening. She clarifies she may have a little bit of a fever now but she has not taken her temperature yet. If she does have one, it is very mild. In the middle of the night, she started to feel uncomfortable, like right under her armpit, it was sore. She woke up this morning and stated it was pretty noticeable, there was swelling kind of like under her armpit, but its more towards her chest a little. The area was very uncomfortable and very sore. She confirmed she started feeling the armpit swelling and soreness overnight last night. It's still very uncomfortable and sore. Treatment included she took 2 Acetaminophen pills, 500mg each, yesterday around 2pm and took 2 pills before going to bed last night around 8:00pm. The adverse events didn't require a visit to emergency room or physician's office. Patient had blood work in Mar2021 that showed that she had antibodies in her system. In Dec2020, patient's husband was positive for Covid and she was negative. The outcome of event feel uncomfortable unknown, armpit swelling and soreness was not recovered, the other events was recovering. No follow-up attempts are needed. No further information is expected.
54 2021-04-24 tingling, feeling hot my left arm and the left side of face became very hot; I have pins and needles tingling and numbness... Read more
my left arm and the left side of face became very hot; I have pins and needles tingling and numbness along the left side of my body; This is a spontaneous report received from contactable consumer (patient) via Pfizer-sponsored program. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: El6955) via an unspecified route of administration in the left arm on 19Mar2021, 15:45 (at the age of 54-year-old) as a single dose for COVID-19 immunization in Pharmacy or Drug Store. Medical history included left foot surgery in 1997. Patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included liothyronine sodium and levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, about 25 minutes after injection, patient left arm and the left side of face became very hot, after that, and still to this day the patient experienced pins and needles tingling and numbness along the left side of body including fingers, arm, face, leg and foot. All on left side. The patient did not receive any treatment for the events. The outcome of the events was unknown.
54 2021-04-24 speech disorder, coordination abnormal, nerve pain passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; so... Read more
passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; sores in her mouth and nose; sores in her mouth and nose; anal hemorrhoid sores; had difficulty speaking, with her words; has been dropping things, she has broken glass; her eye felt heavy and her eye was drooping; Dizzy; Fall; Slight fever; Fatigue; extreme pain through right side (right side means her shoulders, neck, torso, arm, and entire leg); first dose given 14Jan2021, and second dose given 07Mar2021; first dose given 14Jan2021, and second dose given 07Mar2021; Shortness of breath; severe nerve pain; Vomiting; had a feeling of urination, like she had to urinate when she didn't, that feeling of urination; Disorientated; eye pain like pins and needles; skin is burning and painful to the touch; Headache; joint and muscle pain; joint and muscle pain; Nausea; horrible lack of appetite/couldn't eat anything other than soup; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program called COVAX US Support. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunization. The patient's medical history included history of three spinal surgeries (takes no pain meds, she is not on pain meds, she has never been on or kept taking them); and has "neuropathy and nerve related issues" that were not this bad since ten years ago in 2011, clarified that what she has is not actually neuropathy, something with the peripheral nerve, she says she doesn't remember actual verbiage), since ten years ago in 2011, and the only difference was this vaccination, it was not this bad until this vaccination. She doesn't react well to pharmaceuticals anyway (unspecified). Her medications are that she takes the minimum amount of medications, very minimal (unspecified). There were no concomitant medications. There was no other products. Also, she has not had any other recent vaccinations or started any new medications. For past drug, she didn't take anything other than 5mg of zolpidem tartrate (AMBIEN) to sleep at night because of her spine. Patient previously also took pregabalin (LYRICA) and was off it, was also on gabapentin or neurontin (patient did not have those medications to provide NDC/LOT/EXP for either of them because she took them back to the pharmacy or turned them in to the police station because she doesn't keep medications in her house if she isn't taking them, and she couldn't take that medication). Historical vaccine included first dose of bnt162b2 on 14Jan2021 (at the age of 54-year-old; Lot Number: EN5318) in Arm Right for covid-19 immunization, and for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. She received both doses of vaccine. Her first dose was LOT: EN5318 and was given 14Jan2021, and her second dose was LOT: EN6204 given 07Mar2021. The patient was reporting for Pfizer COVID-19 vaccine, for she was having a horrible reaction to it "45 days" (as reported) after taking 2nd dose, and had been in the ER, and her temperature still hasn't gone back down to her normal, her oral temp is still raised and her rectal is raised even more. She was not feeling well, she felt very bad, she would never get a vaccine again, that is how bad it was. Since "45 days" later she was still having significant pain and trouble flexing her right hand open and closed. For events treatment, she took over the counter Tylenol for fever and pain, strength unknown. Patient said she had not had this kind of disabling symptoms or anything before this vaccination. She had a slight fever almost the whole "45 days". On 08Mar2021, her oral temp was over 98 degrees Fahrenheit when her norm temp being 97.2 or 97.3degrees Fahrenheit. Her rectal temp stayed at 100 degrees Fahrenheit. The next day, actually on the 09Mar2021 (which was two days after her second dose), she had the slight fever, fatigue, and extreme pain through her right side. She said her right side means her shoulders, neck, torso, arm, and entire leg. She also had shortness of breath, and severe nerve pain. She called her primary care provider who said to wait 5 days to be seen. On day 5, or actually the whole five days (reported as in Mar2021), she was in bed and didn't leave her apartment because she was in bed and she was vomiting. On day 2 or within 6 hours of vaccination, she had a feeling of urination, like she had to urinate when she didn't, that feeling of urination was equivalent of having contrast dye (NDC/LOT/EXP: Unknown) put in her IV which makes her feel like she is peeing her pants but she did not, and that feeling has not gone away. On day 5 (11Mar2021), she was dizzy and fell. In Mar2021, she was disorientated and vomiting, she couldn't eat anything other than soup. On day two (Mar2021) she had some kind of eye pain that is still there "45 days later", it feels like pins and needles. Her skin was burning and painful to the touch, she couldn't keep an IV in her when she was in the ER. She was not admitted to the hospital. She was having headaches, and joint and muscle pain. She had nausea and vomiting at different times. She continued to have shortness of breath. She had a horrible lack of appetite. She had sores in her mouth and nose. She had anal hemorrhoid sores. Last night (05Apr2021 )she had a headache that was severe like someone put a knife behind her right eye, and when she got up (06Apr2021) her eye felt heavy and her eye was drooping. She also had difficulty speaking, with her words. She says she had passed out, and had been dropping things, she had broken glass. She has been to a neurologist and a gastroenterologist. She clarified that all of these events were after her second dose, for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. None of her doctors know what to do, her gastro doctor was giving her an anti inflammatory suppository and was going to do some tests. She had blood done from neurologist and at the ER and no one knows what to do, they keep referring her to other doctors. She wished someone could explain to her, but no one know and they said it was uncharted territory, they didn't know what to do. She is now back on Lyrica which she was off of but the ER prescribed her 300mg three times a day. She wanted to know what the hell is going on with this vaccine, and that she doesn't think having these side effects "45 days" out is normal. She wanted to be transferred to speak with someone about what to do because her doctor's don't know anything. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
54 2021-04-25 depressed level of consciousness Patient presents with a potential reaction to the COVID19 vaccine. I was called to the patient's car... Read more
Patient presents with a potential reaction to the COVID19 vaccine. I was called to the patient's car outside of the vaccination area at the traffic circle for a report of a patient not breathing. Upon arrival, the patient was responsive, but minimally. She was pale and diaphoretic. The patient was placed in the supine position with legs up. Her airway was open. There was no sign of systemic allergic reaction of anaphylaxis. Rather, presentation was consistent with a severe vasovagal episode with syncope. EMS was summoned. The patient's pulse, BP and SpO2 were WNL on initial exam. The patient was moved back to the monitoring area. Over time, the patient became more responsive, however, began to have significant emesis on multiple occasions. She was not able to tolerate oral hydration. SL Zofran 4mg was given via EMS. Emesis abated. The patient was moved to the stretcher in the ambulance. A peripheral IV was started and 1000ml NS was given. BG was 121. Patient's level of consciousness improved, however, emesis remained profuse and dark in color. Plan: Patient presented with a severe vasovagal episode with subsequent severe emesis with an inability to tolerate PO fluids. Despite SL Zofran and 1000ml of NS, symptoms didn't improve. As such, patient was transferred via EMS to the ED.
54 2021-04-25 flushing client received the 1st Pfizer Covid vaccine. Client was sitting approximately 25 mins when she aler... Read more
client received the 1st Pfizer Covid vaccine. Client was sitting approximately 25 mins when she alerted EMTs she was feeling flushed in face, palms of hands and itchiness over body. 1005 vitals: blood pressure 140/80, pulse 91, oxygen 97%. PHN joined team. Upon arrival, client with flushing to face and hands. Alert and oriented. Client denied shortness of breath. Per client has history of allergy to shrimp. Medical history of hypothyroid and diabetes. Medications for both medical conditions, unable to recall names and daily vitamins. PHN offered client Benadryl, 50mg given orally at 1007. Per client husband could pick her up. 1010 vitals: blood pressure 110/86, pulse 82, oxygen 98%. Symptoms same per client. New onset of feeling "scratchy throat". Client denied shortness of breath or feeling throat was closing. 1015 vitals: blood pressure: 110/86, pulse 86, oxygen 99%. 1017 noticed redness of palms improving and flushing of face. Per client warmth feeling improving. 1020 vitals: blood pressure: 110/86, pulse 82, oxygen 97%. Per client itchiness resolved. Skin color with slight redness. Per client throat feeling improving. Vitals at 1030: blood pressure 112/78, pulse 87, oxygen 98%. Per client all symptoms resolved. Skin color back to normal. Client advised to speak with primary provider prior to second dose, use of V-Safe. ER precautions also given if symptoms returned after leaving. Per client ready to leave, had completed additional 30 min observation. Client advised to have someone pick her up, client declined. Per client feeling fine to drive herself. Client left facility with a steady gait at 1040.
54 2021-04-25 flushing patient returned to pharmacy with flushing. pt took a Benadryl, during observation patient's face ... Read more
patient returned to pharmacy with flushing. pt took a Benadryl, during observation patient's face became bright red and tight. Also presented with a petechial rash on neck. Patient refused off of epipen and patient would not allow us to call 911 but patient agreed to let her husband take her to the doctors care near by. patient had no trouble breathing and no swelling of tongue or lips. pt said she would keep us posted.
54 2021-04-25 pain in extremity, breast pain Right arm badly hurting, pain and swelling in under arm and breast on the right side. Very very pain... Read more
Right arm badly hurting, pain and swelling in under arm and breast on the right side. Very very painful.
54 2021-04-26 weakness chills; fatigue and weakness lasting 12 hours
54 2021-04-26 numbness The left side of my body feels tingling and numbness; tingling on the left side of my mouth; This is... Read more
The left side of my body feels tingling and numbness; tingling on the left side of my mouth; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6200, Expiry Date: unknown) on 22Feb2021 15:00 via unspecified route of administration in the left arm on at single dose for COVID-19 immunization. The patient denied any medical history. She had no known allergies. The patients concomitant medications were not reported. Subsequently at the same time, after receiving the vaccine, the patient felt tingling and numbness in left side of her body. It started on her left calf, and she could mostly feel numbness and tingling on the left side of her mouth. The reporter assessed the events as non-serious. No emergency room or physician office was involved. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. There were no relevant test. It was unknown if the patient received treatment. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
54 2021-04-26 pain in extremity Presented to the ED on 4/25 with severe R calf swelling and pain x4-5 days. Found to have ACUTE THRO... Read more
Presented to the ED on 4/25 with severe R calf swelling and pain x4-5 days. Found to have ACUTE THROMBOSIS IN THE DEEP VEINS OF THE RIGHT FEMORAL, POPLITEAL, POSTERIOR TIBIAL, PERONEAL VEINS and ACUTE THROMBOSIS IN THE DEEP VEINS OF THE RIGHT CALF. Admitted for systemic anticoagulation and possible catheter-directed thrombolysis given extent of clot burden and symptoms.
54 2021-04-26 tingling The night after the second injection, she started feeling tingling on the left hand fingers tips and... Read more
The night after the second injection, she started feeling tingling on the left hand fingers tips and pain in the left knee and ankle. After one to two days the pains subsided but the knee keeps warbling and shakes when she try to walk or stand on it. Up to now, the tingling is not severe as at first but warbling is almost the same.
54 2021-04-27 breast pain Tenderness, burning and hurtful left breast; Tenderness, burning and hurtful left breast.; Really ru... Read more
Tenderness, burning and hurtful left breast; Tenderness, burning and hurtful left breast.; Really run down and tired as expected.; This is a spontaneous report from a contactable consumer, the patient. This 54-year-old non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via unspecified route in the left arm on 23Mar2021 at 15:15 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included overweight. The patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. On 24Mar2021 at 12:00 AM, the patient experienced tenderness, burning and hurtful left breast, especially around the of the breast almost as if touching a splinter on the breast. The patient also reported she was really run down and tired as expected. There was no treatment received for tenderness, burning and hurtful left breast, run down and tired. The clinical outcomes of tenderness, burning and hurtful left breast, run down and tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
54 2021-04-27 feeling hot Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn'... Read more
Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe; almost like she couldn't breathe/Difficulty Breathing; Felt funny in her chest, like a really weird, really warm and heavy feeling/ warm feeling in the chest; having an anaphylactic reaction from the vaccine; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Very sore right arm where she was given the injection; felt like she was punched several times in her arm; Injection site bruising; This is a spontaneous report from a contactable nurse(patient). The nurse reported similar events for herself and her husband. This is the first of two reports. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), dose 1 intramuscular, administered in arm right on 10Mar2021 16:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included severe asthma which started as a child and then it went away and then as an adult it got severe around 2010 and ongoing, she was an asthmatic and would panic and start feeling worse. She had ongoing chronic obstructive pulmonary disease (COPD), brain surgery in 2007, low immune system, allergies to cephalosporins, pulmonary and stomach issues; and bradycardia (as her BP usually runs 90/45 and she is bradycardic). Concomitant medications included tiotropium bromide (SPIRIVA RESPIMAT), salbutamol sulfate (PROAIR HFA), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol (VENTOLIN [SALBUTAMOL]), and montelukast (MONTELUKAST), all taken for asthma, chronic obstructive pulmonary disease from an unspecified start date and ongoing; clarithromycin (CLARITIN [CLARITHROMYCIN], omeprazole, phenytoin sodium, azelastine, ipratropium bromide, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and ipratropium bromide, salbutamol sulfate (DUONEB), all taken for an unspecified indication from an unspecified start date and ongoing; prednisone taken for an unspecified indication from 2021 and ongoing as she was on this steroid 2 weeks before the vaccine; and azithromycin which she takes prophylactically for her low immune system from an unspecified start date and ongoing. She was on a lot of medications period and most are for her pulmonary and stomach issues. The patient previously took propofol, Versed, Nitrous Oxide, and Percocet wherein the patient had drug hypersensitivity and anaphylactic shock with these; adhesive from nicotine patch made her arm to get red and swollen (Dermatitis contact). She previously took EpiPen for anaphylaxis. It was reported that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She got her vaccine at a hospital in their clinic and she was transferred from the vaccine clinic to the ER. Stated she was given a shot with an Epi-pen in her thigh at the clinic and transferred to the ER. In the ER, she was given Benadryl and watched for 4 hours. She would state this was medically significant because of airway, breathing, circulation and she felt like she couldn't breathe. She added that it was kind of weird and freaky. She mentioned that along with that, shortly before she was released from the ER, she experienced a very sore arm where she was given the injection. She heard that was very common so she dealt with it. However as the night progressed, it got increasingly worse, it almost felt like she was punched several times in her arm. It probably started between hour 3 and 4 after receiving the vaccine. She added that she had a very sore right arm where she was given the injection; felt like she was punched several times in her arm. It was not serious, just annoying and it was gone 3 days later. She had injection site bruising on 10Mar2021. She stated that she knows this because she was a nurse, but a lot of times, people experienced this reaction when they are given Dilaudid wherein they get a warm feeling in their chest, so they push it really slow and dilute it with saline so it doesn't have the respiratory factor. She stated that this was kind of what the feeling was like for her and it was scary because she didn't expect it. She stated that the ER team that assessed her said, because she wasn't used to that feeling, she may have had a panic attack and that may have made it worse. After she was treated, she spoke with her husband and he had the shot two minutes before her and he had the same feeling but he didn't freak out and didn't want to appear weak. Stated he told her he had the same feeling and it lasted 5 minutes and then it went away. Stated since she got scared, it made it worse. She doesn't know if she had a panic attack that made it worse. She stated that of course her husband didn't tell her that until she was out of the ER, that it does go away. That made her feel better because she wasn't the only one that experienced that. States he didn't say anything about it, because he was worried about her, he said it was a warm feeling in the chest and not being able to breathe but he didn't want to say anything because she was an asthmatic and would panic and start feeling worse. She mentioned that they weren't going to let her get the second dose, so she went to an allergy doctor and told them what happened and about her husband having the same reaction and because she was severely immunocompromised. Stated the hospital said they were not giving her the second dose unless an allergist says it is safe and sets a protocol and he had to write a letter to the hospital. Stated she was pre-medicated 24 hours before the vaccine with 50mg Benadryl, 50mg Benadryl the day of the shot and 50mg of Benadryl two days after the shot. Stated she will have full immunity on 14Apr2021. She added that she had a pulmonary doctor, brain cancer doctor, ENT doctor, stated they don't know if it was caused by the vaccine, but they are pretty sure she had a reaction but they can handle it with pre-medicating her. She received the second vaccine on 31Mar2021. She mentioned that she was happy to be able to get her second shot. She stated that at first they didn't want to give it to her because of her reaction but she kept calling. So she went to a hospital to saw an allergist and he had to sign off that it was safe to give her the second shot and under what circumstances. Stated she had the letter from the hospital that she was seen by them and she needed to be pre-medicated and it had to be given at a hospital that had the ability to intervene quickly and she needed to be watched for at least 30 minutes after the vaccine. She mentioned that to go through what she went though, and not be able to get would have been disappointing. Because of her immune system, it is important to get the shot and there was a way around the reaction which worked for her. She added that even having an anaphylactic reaction from the vaccine, she was able to recover quickly. Stated with having asthma, COPD and a low immune system, she may not recover from Covid. It makes sense they evaluated it and came up with a solution and a pre medication protocol and when and how long and she was still able to get the shot because it is important. Answers to follow up questions indicated that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She was given the shot and getting ready to get out of the chair and her husband was about to sit down for his shot. Stated she would say the time of the course of the reaction was within under 5 minutes of her injection. The patient required medical intervention with Epi-Pen, Benadryl, and Duo-Neb. The patient was not hospitalized because she was immunocompromised, it was better to watch herself at home and because she had an Epi Pen at home in case she has that sort of reaction returning over a 72 hour period. Stated they instructed her husband and told them if she felt any different to come back to ER. She was not admitted to the ICU. Organ involvement included: Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress. The event required initiation of new medication or other treatment or procedure including Epi-Pen, Benadryl, DuoNeb. Patient have a history of previous allergies: Medication Allergies to Cephalosporins, Anesthesia medications: Propofol, Versed, Nitrous Oxide, Percocet: Anaphylactic shock; Adhesive from nicotine patch, caused her arm to get red and swollen. She takes EpiPen as she had previous history of allergies and since she had multiple medication allergies and had a history of quickly going into anaphylaxis, stated her BP usually runs 90/45 and she was Bradycardic. She did not receive any recent vaccines for any other conditions prior to the events being reported. She did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. She has not received any other vaccines around the time of the Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient recovered from 'felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe', Difficulty breathing, and 'warm feeling in the chest' on 10Mar2021; while having an anaphylactic reaction from the vaccine, Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress were recovered on an unknown date; Vaccination site pain recovered on 13Mar2021 and Injection site bruising recovered on 18Mar2021. Therapeutic measures were taken as a result of all events except Vaccination site pain and Injection site bruising. Relatedness of drug to reactions/events: Reaction assessed for events "felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe", 'very sore right arm where she was given the injection; felt like she was punched several times in her arm.' and Injection site bruising: Method of assessment: Global Introspection: Drug result: Related. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, the Company considered all serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological sequence. Current patient conditions of asthma, chronic obstructive pulmonary disease and allergic diathesis may have been considered as favoring factors in development of reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021406773 same reporter and drug, similar events, different patient
54 2021-04-27 pain in extremity a little bit of a headache; cough; typical sore arm; This is a spontaneous report from a contactable... Read more
a little bit of a headache; cough; typical sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) dose 1 via an unspecified route of administration on 29Jan2021 (Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 29Jan2021, the patient experienced typical sore arm, on an unspecified date, experienced a little bit of a headache and cough. She thought that cough was the oddest thing. She does not have her CDC vaccine record card with her. Sore arm started on 29Jan2021, that evening she could feel it; by really feel it 30Jan2021 but it did not hinder her in any way shape or form. Cough onset date unknown other than in middle of the night, probably about midnight. She kept coughing and coughing; it was a very peculiar cough. She does not think she has ever had that kind of cough before. It was like a dry cough and she just kept coughing. Finally, she got up and she had those pearls, she was not sure of the name of the pearls; but she had some of those pearls and took that and went back to sleep. She got up and had a slight headache, a little bit of a headache nothing big but a peculiar headache; not one she has ever had before. She went and fed the homeless, she felt the sore arm but it did not hinder her in any way shape or form. She was getting ready for bed and the cough started again. She took the pearls again, went to sleep, no problem. She woke up and her arm was fine, no coughing. She recovered completely from all of these events with Pfizer COVID-19 Vaccine. She is scheduled to get the second dose of Pfizer COVID-19 Vaccine on 17Feb2021. She had been hearing the consensus that it seems like the second one was the booger so she was hoping to have as mild symptoms this time with second dose as the first. Pearls were just something she had that probably expired or might be from the beginning of the year before COVID; you know how in spring things start so she probably still had it from last year but the pearls worked fine, she had no problem. Pearls: Lot, NDC, Expiry were unknown, she does not have product with her. Therapeutic measures were taken with pearls for event cough. The outcome of typical sore arm was recovered on an unspecified date in 2021, and headache and cough were recovered. Information on batch/lot number was requested.
54 2021-04-27 tingling I waited 15 minutes before leaving the facility. I got out to the car and my cheeks and chin start... Read more
I waited 15 minutes before leaving the facility. I got out to the car and my cheeks and chin started tingling and were red, I started to have a slight reaction. On the drive home, I started to get a metallic taste and was starting to have difficulty swallowing. I advised my husband of this. The difficulty swallowing and metallic taste subsided after 2 days. It never got to the point where I needed to go to the ER. NOTE: After the first dose, the only side effect I had was tiredness for 1 day and a headache for 2-3 days.
54 2021-04-28 weakness weakness-sudden onset. 15minutes later at 11:25am feeling better
54 2021-04-28 tingling, numbness woke up left side of face was numb and tingling like a shot of novocaine.
54 2021-04-29 breast pain Immediate redness in face (similar to Rosacea). Approximately 30 minutes later, swelling in face, ha... Read more
Immediate redness in face (similar to Rosacea). Approximately 30 minutes later, swelling in face, hands and feet, dizziness, and fatigue. Swelling in face, hands and feet, fatigue, fever x 3 days. Dizziness x1 day. Rosacea x1 day. Since vaccine, I have had bouts of shortness of breath, and occasional pain in my left breast area near the heart.
54 2021-04-29 facial paralysis, involuntary muscle movements, slurring Vaccine administration provided to left deltoid at 8:20a.m. While in recovering in the Obs area, pa... Read more
Vaccine administration provided to left deltoid at 8:20a.m. While in recovering in the Obs area, patient complained of left arm heaviness, left chest pressure and dizziness. The patient was positioned in a wheelchair; during transport to the on site medical tent, the patient started passing out. Prior to arriving at the Medical tent, the patient began flailing her arms, panicking and respiratory rate was observed to be a rate of about 60 breaths minute. She was soothed and was observed to slow down her breathing and was subsequently transferred to a supine position on a stretcher. She was provided water and a granola bar and EMS was summoned; Vital signs were 160/90, HR 76, SPo2 96% on room air. EMS requested. The patient refused transport to the hospital; EMS assessed; BP was 138/88. The patient stated that she felt better and refused transport to a local hospital. She was continued to be observed; approx 5 minutes later she complained of visual blurring, a headache, and was observed to have a facial droop and word slurring. Advised by EMS to be transported to hospital; she then agreed to transport to a local hospital.
54 2021-04-29 numbness, tingling Pt stated that within 10 minutes of receiving the vaccine, her L side went numb- pins/needles, could... Read more
Pt stated that within 10 minutes of receiving the vaccine, her L side went numb- pins/needles, could not bear weight on L leg, it buckled beneath her. The vaccination site had her stay 45 minutes, she stated that they checked her bp and it was wnl. They had her call someone to drive her home and she was told to seek care if symptoms did not improve. She called the Covid hotline and reported these symptoms to me. The Left sided numbness is improving but she also is c/o swelling in her L wrist and ankle and a feeling of dehydration, not being able to get enough water. These are new symptoms to her. She states no h/o DM. She is not having any other symptoms of CVA, no speech issues; no symptoms of anaphylaxis- no tongue/throat swelling, no difficulty breathing. I told her to take 50 mg of Benadryl and have someone bring her to the hospital ED. I told her to call 911 if symptoms worsen or become severe. She was in agreement.
54 2021-04-29 nerve pain, weakness 4/26; 6pm - 4/27; 12am: mild aches, fatigue, and mild chills 4/27; 12am - 6pm: extreme chills, extre... Read more
4/26; 6pm - 4/27; 12am: mild aches, fatigue, and mild chills 4/27; 12am - 6pm: extreme chills, extreme all-over body aches, nerve pain, myalgia, severe headache, weakness and fatigue, confusion and disorientation, high fever 103 - 104 4/27; 6pm: fever got as high as 106.2 - Treated with ice packs and ice water and went to ER 4/27; 6pm - 9 pm: fever and other symptoms lessened, and continue to lessen now, 4/30
54 2021-04-29 pain in extremity, tingling Tinnitus. Severe and non relenting . Aches in legs especially left side. Pain in left arm and tingl... Read more
Tinnitus. Severe and non relenting . Aches in legs especially left side. Pain in left arm and tingling in left hand/foot
54 2021-04-29 pain in extremity 04/19/2021 at 8:00am woke up with a very bad headache. Temperature of 101.2. Sat in dark room with i... Read more
04/19/2021 at 8:00am woke up with a very bad headache. Temperature of 101.2. Sat in dark room with ice bag on head and use of tylenol. Drank soda and sat quietly. 04/20/2021 7:30 am. Headache gone with fever. Left arm is now very swollen. Hot to touch. Itchy. Achy. And about a 4? wide rash band on my left arm near crease/ elbow. 4-29/2021 rash is still slightly visible but fading. No heat emitting from it.
54 2021-04-29 tingling At 1500 medic made contact with client who was sitting in observation status post 2nd dose Pfizer CO... Read more
At 1500 medic made contact with client who was sitting in observation status post 2nd dose Pfizer COVID vaccine. Client reported feeling lightheaded and had tingling in fingers and on tongue. She stated she had the symptoms after her first dose of Pfizer COVID vaccine received 04/02/21 (LOT: EW0150, Expiration 07/31/2021). Client stated she spoke with her primary care provider who advised her to receive second dose of vaccine and to be aware symptoms may reappear with second dose. Medic noted that client was alert and oriented to time, space, person, and situation (CAOx4) and had positive pulse, motor, sensory and capillary refill (PMSC) responses. At 1508 baseline vitals signs were obtained with client sitting in zero gravity chair: Blood pressure (BP): 110/80, Respiratory Rate (RR): 14, Heartrate (HR): 69, pupils were equal, accommodating, round and reactive to light (PEARRL), Skin: normal color for ethnicity, warm and dry. At 1510 client was reassessed for lightheadedness, client stated she was no longer lightheaded but still felt tingling in hands and new onset of "having to think about swallowing". Client denied shortness of breath (SOB), headache, chest pain, nausea, vomiting, blurry vision, sensation of throat closing, or mouth and lips swelling. Client was CAOx4. At 1512 50 mg Benadryl oral suspension administered to client. Client continued drinking water without any difficulty and denied dysphagia. At 1518 second set of vitals taken while sitting: BP 112/60, HR: 66, RR 14, PEARRL, reassessed symptoms and client stated improvement of tingling sensation, positive PMSC, client rated symptoms a 4/10 and continued to deny SOB, headache, chest pain, nausea, vomiting, blurry vision, and throat closing. Client stated she felt very thirsty and a second bottle of water was given to client. Client advised to stay longer in observation. At 1529 third set of vitals taken while client standing: BP 116/80, HR 68, RR 14, PEARRL, CAOx4, client negative for orthostatic pressures. At 1542 client released from care after a total 1 hour observation. She was able to stand and walk on her own accord away from the site with a steady gait.
54 2021-04-29 tremor Fever, uncontrollable shaking, extreme lethargy, unbearable headache, all over body pain. Symptoms ... Read more
Fever, uncontrollable shaking, extreme lethargy, unbearable headache, all over body pain. Symptoms lasted approximately 72 hours
54 2021-04-30 discomfort, tremor, weakness high blood pressure; fast heart beat, fast blood stream; fast heart beat, fast blood stream; weak; s... Read more
high blood pressure; fast heart beat, fast blood stream; fast heart beat, fast blood stream; weak; shaking; very uncomfortable horrible feeling; very uncomfortable horrible feeling; faint; adrenaline rush; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 15Apr2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included low TSH and high blood pressure. Patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium; losartan potassium (LOSARTAN "AGP"); vitamin D3; cissus quadrangularis (CQL); all taken for unspecified indications, start and stop dates were not reported. On 15Apr2021, the patient had three times adrenaline rush at 16:10, 16:30 and 18:20. It came automatically at 16:15 (as reported) with high blood pressure, fast heart beat, fast blood stream, faint, weak, shaking, very uncomfortable horrible feeling. Usually, this feeling will come after something happen and impact the brain, but now it came just by itself. Patient has feeling that she might die. She wanted to know if this vaccine affected her nerve system and if she should take the second dose or not. No treatment received for the adverse events. The patient underwent lab tests and procedures which included on 08Jan2021, colonoscopy: none, nucleic: none and nasal swab: negative; on 08Apr2021, colonoscopy (received within 2 weeks of vaccination): unknown results; and on an unspecified date (since the vaccination, the patient been tested for COVID-19) nucleic acid test: unknown results. Outcome of events were recovered on an unspecified date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
54 2021-04-30 mild one side paralysis Weakness on right side of body; Extreme visual disturbances in right eye that won't go away; Nausea;... Read more
Weakness on right side of body; Extreme visual disturbances in right eye that won't go away; Nausea; Chills so bad I was hyperventilating; Chills so bad I was hyperventilating; This is a spontaneous report from a contactable consumer reporting for herself. A 54-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 08:15 (Batch/Lot number was not reported) as single dose, Medical history included hypertension. The patient's concomitant medications were not reported. The Patient received the first dose of BNT162B2 vaccine on 23Mar2021. The patient experienced weakness on right side of body on 13Apr2021 19:00 with outcome of not recovered , extreme visual disturbances in right eye that won't go away on 13Apr2021 19:00 with outcome of not recovered , nausea on 13Apr2021 19:00 with outcome of not recovered , chills so bad I was hyperventilating on 13Apr2021 19:00 with outcome of not recovered. The events weakness on right side of body and extreme visual disturbances in right eye were considered Important Medical Events. The patient visited the ER because of the events and underwent CT scan, ultrasound, multiple medications. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
54 2021-04-30 nerve pain Fever, Chills, Joint pain, Headache, Fatigue, increased nerve pain, arm pain at injection site
54 2021-04-30 tingling, involuntary muscle movements, feeling hot, numbness I didn't feel well all night, achy and uncomfortable. In the morning, while getting ready to shower ... Read more
I didn't feel well all night, achy and uncomfortable. In the morning, while getting ready to shower for work, I got extremely hot and laid on the bathroom floor. Shortly thereafter, my left hand began to tingle and became numb and the numbness extended to my entire arm. My fingers locked into a claw and I couldn't move them. Then, my right hand and arm did the same although not as severe. My feet began to tingle too. It lasted probably a couple minutes and then all went away and I actually felt better than before. I showered, went to work but felt stiff, achy, headache and very tired. I left work at 12:30pm and went home and slept. The following day was much better, just slight headache and I now have a cough that I didn't have before.
54 2021-05-01 pain in extremity Patient with left arm pain that started after vaccination, and continued after 6-7 weeks. Has improv... Read more
Patient with left arm pain that started after vaccination, and continued after 6-7 weeks. Has improved over time, but will need physical therapy.
54 2021-05-01 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
54 2021-05-02 weakness Difficulty breathing. I went to the emergency room after speaking to an on-call nurse on May 1, 2021... Read more
Difficulty breathing. I went to the emergency room after speaking to an on-call nurse on May 1, 2021. In order to get a good breath, I had to periodically do deep inhales and exhales. This was scary and I am concerned about taking a booster shot. I also had major chills; body and muscle aches; dizziness and weakness; fast heartbeat.
54 2021-05-02 cold sweat, migraine 1.5 days after vaccination, I woke up feeling like I had a horrible hangover. I had a migraine, naus... Read more
1.5 days after vaccination, I woke up feeling like I had a horrible hangover. I had a migraine, nausea, dizziness and lightheadedness. I felt like I could vomit. My stomach was torn up, cramping and burning. I was clammy and sweating 100% of the time. I had debilitating fatigue. I was sleeping a lot. My chronic pain was much worse. My arthritis was inflamed. I was unable to do anything but lay in bed or help myself to the bathroom. This was all the time!! I am very sick still.
54 2021-05-02 feeling hot While sitting in observation following vaccine administration pt told observation nurse that she fel... Read more
While sitting in observation following vaccine administration pt told observation nurse that she felt "warm" and "faint". She stated she felt well enough to walk so she was brought to EMS guided by RN and care was transferred to EMTs. With EMTs she was placed in wheelchair and wheeled outside for fresh air. With EMTs she reportedly lost consciousness for ~30 seconds. When she regained consciousness vitals taken by EMTs were reportedly BP 150/80, HR 68, and O2 98%. She reported chief complaints at this time to be fatigue, nausea, and chest pain. She was then transferred to ED via ambulance with onsite EMS for further evaluation.
54 2021-05-02 numbness Left side facial numbness
54 2021-05-02 migraine Fever, chills, terrible migraine all day - no medication helped, body aches, exhaustion, SHINGLES. ... Read more
Fever, chills, terrible migraine all day - no medication helped, body aches, exhaustion, SHINGLES. I was out of work for 2 weeks.
54 2021-05-02 pain in extremity Hives all over body- arm, legs, back. Shoulder, stomach, thighs, buttocks, hips, knees.. Has persis... Read more
Hives all over body- arm, legs, back. Shoulder, stomach, thighs, buttocks, hips, knees.. Has persisted now for one month following injection although beginning to subside on certain areas like left arm but still present on right arm and other parts. As hives subside., bruising follow so I suspect Uticarial vasculitis.
54 2021-05-02 pain in extremity Right foot pain/swelling, redness. could not walk, could not tolerate any weight on foot. Today is... Read more
Right foot pain/swelling, redness. could not walk, could not tolerate any weight on foot. Today is 5/3 and still have slight pain.
54 2021-05-02 tenderness Swollen Lymph Nodes on Right side of neck. Stiffiness to neck and tenderness to touch on Right side... Read more
Swollen Lymph Nodes on Right side of neck. Stiffiness to neck and tenderness to touch on Right side of scalp and neck as well as inside of Right elbow. Moderate to Sever Headache mostly on Right side of head and back of Right eye, low grade fever from 99 to 101.7, Doctor stated to take Ibuprophin 3 times a day, this has provided mild relief of the pain. The tenderness on the neck makes it difficult to sleep. I have been using an icepack to help relieve the pain on the neck and head with some relief on pain.
54 2021-05-02 tremor 5 minutes after I received my shot, I felt dizziness, heart palpitations, and had slight tremors. Th... Read more
5 minutes after I received my shot, I felt dizziness, heart palpitations, and had slight tremors. The back of my head felt heavy. I notified the nurse who measured my blood pressure which was at hypertension levels of 175/98 for 50 minutes and they called 911. They recommended that I go to the ER because my blood pressure kept rising at 45 minutes. After 1.5 hours, I measured my blood pressure at home and it was at 124/75. It took 5 hours for my blood pressure to be at 112/57. I have always been in the normal blood pressure range, so I believe the symptoms were due to the vaccine.
54 2021-05-03 migraine FIRST VACCINE GAVE ME A SORE ARM, TEMPORARY FLU LIKE SYMPTOMS (48 HRS) AND MADE ME CRY UNCONTROLLABL... Read more
FIRST VACCINE GAVE ME A SORE ARM, TEMPORARY FLU LIKE SYMPTOMS (48 HRS) AND MADE ME CRY UNCONTROLLABLY. SECOND VACCINE GAVE ME A SORE ARM, RINGING IN MY LEFT EAR THAT LASTED 30 MINUTES IMMEDIATELY AFTER VACCINE, FEVER, SEVERE BODY ACHES THAT MOVE AROUND MY BODY AND ARE ONGOING (6 WEEKS SO FAR), HEADACHES AND MIGRANE HEADACHES DAILY. (ONGOING 6 WEEKS SO FAR). I ALSO HAVE LOTS OF WATER RETENTION AND UNSURE IF THAT IS PART OF THE VACCINE OR NOT. I ALSO HAVE SEVERE PAIN IN MY LOWER LEFT ABDOMEN THAT MAY OR MAY NOT BE RELATED. IM ALSO VERY TIRED, BUT THAT MAY BE DUE TO THE ONGOING PAIN I FEEL DAILY.
54 2021-05-03 pain in extremity feeling unwell, not healthy; headache; sore throat; chest cough; she tested positive for covid after... Read more
feeling unwell, not healthy; headache; sore throat; chest cough; she tested positive for covid after the first injection; she has had increased resting pulse rate from 90 to between 122-125/very high, elevated, resting pulse at 94 beats per minute/her pulse has been over 100 beats per minute continuously; arm hurt but not very much, arm was just tender; ran a fever of 101 to 104 for seven days/high fever from 101 degrees Fahrenheit to 104 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (Patient). A (Age: 54; Unit: Unknown) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no. EP7534, expiry date not reported) via unspecified route in left arm on 26Mar2021 at 14:40 PM as single dose for COVID-19 immunization. Medical history included anxiety disorder (ongoing), bipolar disorder (ongoing) and bipolar with panic disorder. Concomitant medication included unspecified medication (When probing concomitant medications, she reports she'd been taking psychiatric medications since she was in her 20's. She'd been on all her current medication for at least 3 months or more). No other vaccine in four weeks. The patient experienced feeling unwell, not healthy, arm hurt but not very much, arm was just tender, headache, sore throat, chest cough on an unknown date, ran a fever of 101 to 104 for seven days/high fever from 101 degrees Fahrenheit to 104 degrees Fahrenheit, she has had increased resting pulse rate from 90 to between 122-125/very high, elevated, resting pulse at 94 beats per minute/her pulse has been over 100 beats per minute continuously on 26Mar2021 and she tested positive for covid after the first injection on 01Apr2021. Caller stated she caller to report an experience to the pfizer covid 19 vaccine. Caller stated she had the first dose of the Pfizer covid 19 vaccine on 26Mar2021. Caller stated she tested positive for covid after the first injection and ran a fever of 101 to 104 for seven days. Caller stated she has had increased resting pulse rate from 90 to between 122-125. Caller stated her pulse rate is usually in the 60's mostly 64. Caller stated she was feeling unwell, not healthy. Caller stated she was bipolar with panic disorder and is very scared at this point to get the second dose. Caller wanted to confirm that her increased resting pulse could be a severe allergic reaction. Caller wanted guidance about if or when to receive the second dose. Caller already reported to safety. Caller confirmed her concern was about the increased resting pulse. Caller asked since she had covid, was she protected for 90 days. She was calling about the Covid 19 vaccine. She had her first dose on 26Mar2021, and she immediately had a reaction to it. She had a very high, elevated, resting pulse, it was 94bpm. Since she had received the Covid 19 vaccine her pulse has been over 100 beats per minute continuously. The other thing that was peculiar was that she tested positive for the Covid 19 virus after receiving the Covid 19 vaccine. She had concerned that her pulse has not returned to normal. She has a question about when and if she should get the second Covid 19 vaccine. She was currently scheduled to receive her Covid 19 vaccine on 26Apr2021. She does suffer from an anxiety disorder and bipolar disorder so her pulse rate has been especially frightening for her. She is relieved because her husband has been reading and he's seen some stuff online that people have mental symptoms after the Covid 19 vaccine. She felt better knowing that her medication was still working. Meaning her medication for her anxiety disorder and bipolar disorder is still working. She has no further information on the people online. She reports her arm hurt but not very much. That started the same day that she received the vaccine. Her arm was just tender, she was aware of her arm. Her arm was only tender about 4-5 days. Her arm isn't bothering her now. She did suffer with a high fever from 101 degrees Fahrenheit to 104 degrees Fahrenheit starting on the day she received the Covid 19 vaccine. She's had no fever at all for the last 2 weeks. The only symptom that remains is her increased pulse. She got the Covid 19 virus test on 01Apr2021. She's not sure if was the rapid or the longer Covid 19 test. She received her results in about 24 hours. She also went to the emergency room on the night of 01Apr2021 because her fever was 104 degrees Fahrenheit even taking the Tylenol. When the Tylenol could no longer manage her fever, she went to the emergency room. She was on her second bottle of Tylenol. She reports the first bottle was the brand name of Tylenol, but she has discarded the bottle. It was the 4-hour kind. NDC/Lot/Expiry not known. The second bottle of Tylenol was the (Company name) Tylenol knock off brand of Acetaminophen. Each tablet was 650mg take 2 tablets every 8 hours as needed. Lot# unknown, NDC 0363-0336-01, Expiry Sep2022. She had to get her glasses to read the print on the (Company name) Tylenol knock off brand. She went to the emergency room because the Tylenol was no longer keeping her fever down and she got frightened. She did not have the Covid 19 test at the emergency room, she had the Covid 19 test. She was sent home from the emergency department. She was not admitted to the hospital. She reports the Covid 19 virus definitely moved through her body starting with a headache, sore throat, and a chest cough. She reports her symptoms lasted a bit longer than her fever. She reports the chest cough lasted the longest. She reports that some people think the Covid 19 vaccine would give you the Covid 19 virus. She believes she had the Covid 19 virus before she received the Covid 19 vaccine. She reports she might have remained asymptomatic until she received the Covid 19 vaccine. The event high fever, elevated heart rate resulted in emergency Room. The outcome of event Pulse rate increased was not recovered, Pain in arm was recovered, whereas unknown for all other events. Description of complaint: PC 1: Tested positive for the Covid 19 virus after receiving the Covid 19 vaccine. Received Covid 19 vaccine on 26Mar2021, tested positive on 01Apr2021. Lot# EP7534 in the left arm NDC/Expiry not known PC 2: She also went to the emergency room on the night of 01Apr2021 because her fever was 104 degrees Fahrenheit even taking the Tylenol. When the Tylenol could no longer manage her fever she went to the emergency room. She reports the first bottle was the brand name of Tylenol but she has discarded the bottle. It was the 4 hour kind. NDC/Lot/Expiry not known. The second bottle of Tylenol is the (Company name) Tylenol knock off brand. Acetaminophen. Each tablet is 650mg take 2 tablets every 8 hours as needed. Lot# unknown NDC 0363-0336-01, Expiry Sep2022 PC 3: She has to get her glasses to read the NDC/Expiry from the (Company name) Tylenol knock off brand. NDC 0363-0336-01 Expiry Sep2022, Lot # unknown No follow-up attempts are possible. No further information is expected.
54 2021-05-04 migraine Migraine lasting 10 days, Additional head pain similar to Bells Palsy onset.
54 2021-05-04 muscle spasms Severe headache, muscle aches, muscles spasms, mild nausea
54 2021-05-04 pain in extremity I went back to the hospital and couple days later they told me that actually I have Deep vein thromb... Read more
I went back to the hospital and couple days later they told me that actually I have Deep vein thrombosis now in my legs; my Crohn's had caused really bad flare up/I have been in the hospital for 5 days now with the clot and Crohn's Flare; I also have superficial clot in that left leg that was the pain began on the edges/blood clot; the arm is much better now. You know that's not really sore; I just was too tired/extreme fatigue; really bad like pain; Shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 29Mar2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, ileostomy from an unknown date and unknown if ongoing, back surgery from an unknown date and unknown if ongoing, Crohn's disease from an unknown date and unknown if ongoing , blood clot in arm back from 2014 to an unknown date. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 08Mar2021 and experienced terrible diarrhea and neuralgia. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; valaciclovir hydrochloride (VALTREX) taken for an unspecified indication, start and stop date were not reported; diazepam (DIAZEPAM) taken for an unspecified indication, start and stop date were not reported; (ZOFRAN) taken for an unspecified indication, start and stop date were not reported; oxycodone (OXYCODONE) taken for an unspecified indication, start and stop date were not reported; lansoprazole (PREVACID) taken for an unspecified indication, start and stop date were not reported. After second dose on 29th (29Mar2021) immediately he was really bad like pain and had shortness of breath. The patient stated that she had a back surgery and so she always felt bad, so she didn't think anything of it. But then she ended up into ER after the second dose and discovered that her Crohn's had caused really bad flare up. She mentioned her foot was looking strange but she was just too tired and left the ER. She then went back to the hospital and couple days later they told her that she actually had deep vein thrombosis now in her legs. She also had superficial clot in that left leg where the pain began on the edges. The patient reported that the vaccine was basically started the Crohn's flare up. The patient also stated that "the arm was much better now and not really sore". The patient was hospitalized for DVT from unknown date and for Crohn's flare up for 5 days. The patient underwent lab tests and procedures which included endoscopy, sigmoidoscopy, ultrasound scan: all on unknown date with unknown result. The patient was treated with Entyvio and on blood thinners now for a blood clot. The outcome of pain in extremity was recovering while others was unknown.
54 2021-05-04 tingling The client received the COVID vaccine (Pfizer dose 1, lot # EW0167, expiration date 5/6/2021) at 143... Read more
The client received the COVID vaccine (Pfizer dose 1, lot # EW0167, expiration date 5/6/2021) at 1430. At 1500, she reported a "pinching" sensation in her left chest, which didn't get worse or better upon inspiration or expiration. The pinching sensation was intermittent and didn't radiate. RN and EMT responded at this time. She denied any shortness of breath or changes in vision, and had no visible flushing, diaphoresis, or swelling. The client was sitting in her chair in the observation area, in no apparent distress. At 1505, the client's vital signs were as follows: blood pressure 144/100, heart rate 82, respiratory rate 12, and O2 96%. Lung sounds were clear to auscultation bilaterally. The client stated her blood pressure is "usually high" but wasn't sure of her exact baseline. The client stated that she hadn't eaten or drank anything yet that day. She was offered water at that time, which she accepted. The client stated she has a history of fibromyalgia, migraines, and obesity, and she takes duloxetine, gabapentin, and vitamins. She has allergies to keflex and ben-gay. The client was alert and oriented. She denied any need to lie down and stated her symptoms were improving. At 1510, the client's vital signs were as follows: blood pressure 140/98, heart rate 78, respiratory rate 12, and O2 98%. She was offered benadryl, which she declined. The client stated that her symptoms had resolved at that time and she wanted to go home. Client advised of recommended 30 minute wait time and educated regarding emergency management, AMR activation, v-safe, and primary care follow up. The client stood up without any dizziness and ambulated to her car with a steady gait, where she was driven home by her husband.
54 2021-05-04 sciatica Back pain into sciatica
54 2021-05-05 feeling hot N/V/D, redness around area of vaccine Began Monday night. Status: improvement, gradual. Aggravated ... Read more
N/V/D, redness around area of vaccine Began Monday night. Status: improvement, gradual. Aggravated by eating. Improvement with Pepto, clear liquids. Associated symptoms include, vomiting, diarrhea, ABD pain, tired Denies: blood in stool or vomit, ENT sx, fever and contacts with same s/s.Pt c/o NVD since Monday. Pushing fluids, urine was a bit concentrated today. She gets occ. pain near the belly button when she eats, up to 8/10, improved w/ heat and pepto, improving. Doesnt radiate. she ? pulled a muscle from vomiting. non-tender, no bulge. No pain w/ movement. Diarrhea improving- x 1 today, watery stool. Has not vomited since last night. Tolerating PO liquids and small amt of toast today. No fevers, felt a bit warm last night. She got her covid vaccine (Pfizer) 1st dose 4/23 and had redness at the injection site which is improving. Supportive care advised
54 2021-05-05 flushing Patient presented with flushing and rash on face within 3 minutes of vaccination. Her throat started... Read more
Patient presented with flushing and rash on face within 3 minutes of vaccination. Her throat started to itch and she was experienced difficulty swallowing without dyspnea. EMS was contacted and obtained vitals upon arrival. Patient was stable with BP of 185/95 and 02 sat of 98% on room air. Vitals remained stable and although rash noticeably improved during observation, the tracheal symptoms did not. Patient was transported to ER by daughter and followed up with me after her treatments. She was given antihistamines and corticosteroids and symptoms subsequently resolved.
54 2021-05-06 discomfort After receiving the first dose on 4/1/21 Lot# ER8733, I had light spotting for 2 days. Second dose ... Read more
After receiving the first dose on 4/1/21 Lot# ER8733, I had light spotting for 2 days. Second dose given 04/23/21 and by 04/28/2021 I started bleeding again And by the second day I was soaking through pads and huge clots were coming out. This has never happened to me before. After 7 days of bleeding heavily I woke up on May 5th at 4:00 a.m. with intense abdominal cramping The only way I can describe was labor. I felt back labor, pelvic pressure, frequent urination and intense pain. I reached out to my gynecologist And he immediately told me to remove my estrogen patch and later that morning he started me on progesterone treatment for 10 days to stop the bleeding. After 7 hours of pain on May 5th, I went to the emergency department and an ultrasound revealed a blood clot. From ultrasound results "there is a complex area in the area of the cervix measuring 5.7 x 3.6 x 2.6 cm." After several hours I was released from the emergency room taking toradol for pain. That evening I passed a huge blood clot! I'm very grateful it was where it was and I could expel it. But there's no doubt the second vaccine caused this issue that has never happened to me before. I still get my periods though irregular and very light. So this event was highly unusual and very painful
54 2021-05-06 flushing, tingling Left sided chest pain, left arm/hand tingling, inspiratory/expiratory wheezes, skin flush and moist.... Read more
Left sided chest pain, left arm/hand tingling, inspiratory/expiratory wheezes, skin flush and moist. No rash, swelling or hives. BP=151/94, P=76, RR=22. Pt. observed, supportive care, transported by EMS to ED for further evaluation and treatment.
54 2021-05-06 flushing Flushing/sweating, vitals wnl. C/o hypoglycemia. Given 3 cups juice, 2 graham crackers.
54 2021-05-06 numbness, tremor Upon going to bed at approx. 11:30 p.m. on the day I received my second dose of the Pfizer COVID-19 ... Read more
Upon going to bed at approx. 11:30 p.m. on the day I received my second dose of the Pfizer COVID-19 vaccine I began to feel quite ill. I was experiencing moderate shaking / shivering / rigors (although I did not feel cold). After a period of time, I was able to get to sleep, but at approximately 2:00 a.m. I woke up and, while lying in the supine position, experienced a convulsive syncopal episode witnessed by my husband. Upon reviving from the episode, I was overcome with more uncontrollable shaking / shivering / rigors and involuntary muscle contractions as well as several other symptoms including malaise, nausea, diarrhea, neck pain and stiffness, possibly a slight fever (didn't have a thermometer handy to use), and a strange feeling I can best describe as numbness on the right side of my face and the right side of my body.
54 2021-05-06 night sweats After my first shot, my period, which is very predictable, came on time, but extremely heavy with lo... Read more
After my first shot, my period, which is very predictable, came on time, but extremely heavy with lots of clotting. I soaked through pads and the heaviness lasted longer than a typical period for me. After my second shot, my period didn't come on time, but instead I had cramping and period symptoms, as well as watery discharge for over a week. Then, it came about two weeks late and lasted for two weeks (though light bleeding this time). I also had sore breast and night sweats. I am likely in perimenopause, but was regular up to this point.
54 2021-05-06 pain in extremity, feeling of body temperature change Mild Itching of fingers and injection site 10 minutes after injection. Moderate itching of hands, fe... Read more
Mild Itching of fingers and injection site 10 minutes after injection. Moderate itching of hands, feet, and neck area. throughout rest of evening. 3AM no more itching, nausea, felt feverish, ( highest temp 99.9) arm very sore took Tylenol every 4 hours. Thurs AM, hot and cold chills throughout the day, entire arm very sore, hands and feet red, hot, swollen, arthritis very painful, Tylenol helpful. Slept most of day and night, felt like I had not slept in days. Friday symptoms persist but beginning to subside.. as of 5:18 PM symptoms light and tolerable. Swelling in hands and feet almost normal, not as tired, body temp fine, only very slight headache occuring.
54 2021-05-07 breast pain all side effects still happening and have been for over a month breast pain (have implants from 1... Read more
all side effects still happening and have been for over a month breast pain (have implants from 1999 and have hysterectomy since 15 years ago) weight gain fatigue infection in body, mostly in bladder area but at this point unidentified blood results all significantly off from recent CBC tests done in 2021 lymphocytes, monocytes, WBC high RBC low, sodium low glucose high, basophils (have at least 4 results to compare to over past 6 months, cbc and chem panel) low tsh headaches heart issues tightness hypertension trouble breathing
54 2021-05-07 pain in extremity headache, chills, fever, arm pain, runny nose, diarrhea, not feeling well
54 2021-05-08 migraine Blood spots on my chest, dizziness, migrane, felt like my knees were stung by bees
54 2021-05-09 feeling jittery, pain in extremity, migraine, tingling Right after my 1st shot in left arm 3weeks earlier at same site (EW0162) I became dizzy, nauseous an... Read more
Right after my 1st shot in left arm 3weeks earlier at same site (EW0162) I became dizzy, nauseous and had tingling/numbness from the knees down to my toes for about 3 hours. Next day sore arm and fatigued. This 2nd shot, had tingling/numbness from the hips down to my toes with shooting intermittent hip pain for about 4 hours after shot. Arm became excruciatingly painful and throughout the night developed fever, chills, migraine, body aches, nausea, sensitivity to light and sound, loss of appetite and taste, extreme fatigue. Continually got worse into Sunday and not feeling much better today. Today little fever but am experiencing everything else and am very jittery and have double vision. Painful having my glasses on.
54 2021-05-09 pain in extremity I Immediately got a headache, lightheaded, dizzy, throat swelling, hard to breathe. A pain under my... Read more
I Immediately got a headache, lightheaded, dizzy, throat swelling, hard to breathe. A pain under my left breast. I could taste the medicine in my throat. Very sleepy. This Lasted several hours until I went to bed , 8:30 pm. I had chills all night. I woke up at 2:00 am, following day with excruciating right arm pain. Also had pain in left arm, head, neck, upper shoulders, legs, ankles, and feet. Also had a pain under my left breast. All of the above symptoms I have had from 05/05/2021 thru today, 05/10/2021 when I went to seek care. (Tired, headache, weak, chills , pain in legs, arms, head & neck, upper and lower back)
54 2021-05-10 weakness waking up and not being able to breath coughing diizziness diarea weakness, hight high rate, shortne... Read more
waking up and not being able to breath coughing diizziness diarea weakness, hight high rate, shortness of breath, dehydration, chills, soreness, unable to sleep
54 2021-05-10 numbness, bell's palsy Developed bell's palsy on the left side of my face; My mouth and side of my face started to feel num... Read more
Developed bell's palsy on the left side of my face; My mouth and side of my face started to feel numb within a half hour of receiving the vaccine; My mouth and side of my face started to feel numb within a half hour of receiving the vaccine; Within 24 hours the entire side of my face from my jaw to my eye was numb; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN0164 and expiry date was not provided), via an unspecified route of administration, in Arm Left, on 15Apr2021 at 10:00 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included bee venom (known allergies). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 15Apr2021 at 10:30 AM, she developed bell's palsy on the left side of her face. Her mouth and side of her face started to feel numb within a half hour of receiving the vaccine. Within 24 hours the entire side of her face from her jaw to her eye was numb. The patient received Medrol 4 mg dosepak and Valtrex - 7-day dose as treatment for the events. The events resulted in physician office visit. Outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
54 2021-05-10 numbness Bursitis; pain to hip joint/Left hip pain; numbness to hand and fingers; numbness to hand and finger... Read more
Bursitis; pain to hip joint/Left hip pain; numbness to hand and fingers; numbness to hand and fingers; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER2613) intramuscular, administered in arm left on 25Mar2021 at 13:25 (at the age of 54-years-old) at a single dose for covid-19 immunisation. Medical history included ongoing asthma diagnosed 4-5 years ago, sjogren's syndrome 11 years ago, systemic lupus (came right after the sjogren's disease), rheumatoid arthritis (in october eleven years ago), fibromyalgia 11 years ago, blood disorder 11 years ago. she cannot think of the other one. There is another breathing one that starts with a C and she does not remember the name of it. She does not have diabetes. She has autoimmune diseases. She has a weird birth defect but did not feel it was relevant. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Lot EN6205) on 03Apr2021, injected intramuscularly in right arm for covid-19 immunisation. The patient experienced pain to hip joint, numbness to hand and fingers in Mar2021 and Bursitis on an unspecified date. It was reported that the patient had second shot on 25Mar2021, and not long after she started experiencing Left hip pain and was not sure what she had done to it. When she saw her rheumatologist, she did an X-ray and found she had bursitis of her left hip. She has also been experiencing problems in her fingertips and toes. She did not realize it until she went through paperwork that they give you that on their it says bursitis of left hip and hand and foot pain is a side effect. She wanted to know if this was all related and if others have had this. Her rheumatologist is sending to neurologist and wondering if she needed to go there or not, or if it is related to the vaccine. She said she grabbed her infusion card. She has been on the same medications for 11 years and did not feel they were relevant. She first had the X-ray of hip and back 2 weeks ago. It showed compression fractures in back and bursitis in left hip. She already had the compression fractures previously diagnosed about 9 years ago. She went to the ER a few days after that for follow up and they did another X-Ray. It did not show any changes. When she went back to her Rheumatologist, she gave her a Bursa shot in left hip. They also sent to emergency room for that. The pain was awful, she could not get into the bed. No additional Vaccines was administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not experience adverse event following prior vaccinations. The patient underwent lab tests and procedures which included Xray of hip and back: bursitis on xray of hip: showed bursitis on left hip, x-ray: Xray of hip Showed Bursitis on left hip and Xray of back showed compression fracture on back. The outcome of the events pain to hip joint, numbness to hand and fingers was not recovered and was unknown for the event Bursitis. No follow-up attempts are needed. No further information is expected.
54 2021-05-10 muscle spasms, weakness spasms in the lower back; headache; little dizziness; tiredness; weakness; having pain and tightness... Read more
spasms in the lower back; headache; little dizziness; tiredness; weakness; having pain and tightness in her neck and shoulders; having pain and tightness in her neck and shoulders; having pain and tightness in her neck and shoulders; having pain and tightness in her neck and shoulders; she describe as pain and tightness in her neck and shoulder and the end it is now moved down to her lower back; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Lot Number: ER8737; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN); colecalciferol (VITAMIN D3); paracetamol (TYLENOL); zinc chloride; lactobacillus acidophilus (FLORAJEN) and Multivitamin. The patient took the first dose of bnt162b2 lot number EN6204 on 15Mar2021 in left arm for Covid-19 immunization. The patient experienced the side effect of muscle spasm in her lower back, a headache, a little bit of dizziness, weakness and tiredness. She had a pain in the neck and shoulder that was kind of more like tightness rather than pain, that she describe as pain and tightness in her neck and shoulder and the end it is now moved down to her lower back she said her neurologist gave her an injection of some kind and she is taking goody powder to help with that pain, she said it goes away for little while and comes right back and she said she also know another female who has the same pain on neck and shoulder after she received the Pfizer vaccine as well. Treatment for events was Tylenol, rapid Tylenol, goody's powder. The outcome was unknown. No follow-up attempts are needed. No further information is expected.
54 2021-05-10 numbness and pain in extremities Ulnar nerve neuropathy of LUE
54 2021-05-10 pain in extremity platelet count dropped down to 126 within a couple of weeks; Pain in left leg; Sore arm; This is a s... Read more
platelet count dropped down to 126 within a couple of weeks; Pain in left leg; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2, dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 10:15 (Lot Number: EW0164) as single dose for COVID-19 immunisation. Medical history included overweight, seasonal allergies and temple headaches. Concomitant medication included ongoing hydrochlorothiazide taken for blood pressure high. The patient previously received first dose of BNT162B2 on 12Mar2021 at 3:00 pm (Lot Number: EN6208), at the age of 54-years-old, in her left arm, for COVID-19 immunization. Temple headaches started before the first dose. Did have a temple headache before, but they seemed worse after first vaccine. The patient experienced sore arm on 18Apr2021 and pain in left leg on 19Apr2021. The patient got the second COVID vaccine on 18Apr2021 (Sunday), a couple of days ago. She noticed that her left leg is sort of painful. She had soreness in her arm Sunday and yesterday, but it's better now. Her questions were about the pain in her left leg. She was wondering if this is part of the muscle ache problem or is it probably something different? was there a way to know the difference on if this is from the vaccine or something else. Yesterday morning, her leg felt fine. In the afternoon it started to feel a little achy. It wasn't anything bad. She took Tylenol which seemed to work. Her leg really bothered her this morning since she woke up this way. She got the first COVID vaccine on 12Mar2021, and on the 17Mar2021, she went to get her blood work done. Her platelet count was down to 148. It is supposed to be 150. Her doctor told her to hold off on the second until they rechecked her platelets. She went and got blood work done again and they dropped down to 126 within a couple of weeks. The events didn't result emergency room or physician office visit. The patient underwent lab tests and procedures which included platelet count 148 on 17Mar2021 and platelet count: 126 on an unknown date. Treatment of the event pain in left leg included Tylenol. The outcome of the event sore arm was recovering. The outcome of the event pain in left leg was not recovered. The outcome of the other event was unknown. No follow-up attempts are needed. No further information is expected.
54 2021-05-10 pain in extremity 3 weeks after 1st vaccine starting 4/10/21, I developed weird and painful swelling, bright red with ... Read more
3 weeks after 1st vaccine starting 4/10/21, I developed weird and painful swelling, bright red with blisters on my right baby toe. Saw a Dr. podiatrist on 4/15/21. He hadn't seen anything like this...but treated it as a staph infection and put me on Sulfamethoxaz-ole-tmp DS for ten days. ( I received 2nd injection COVID vaccine on 4/13/2012)... I needed to fly out of state 4/19/2012 for a family issue ..toe wasn't improving. could not wear enclosed shoe on that foot, swelling on toe so bad that it caused the skin to spit open in several sites and small area of black was at the top of toe from blood. I saw a dermatologist on 4/20/2021 Dr. Solis in Westerly RI and he felt that the antibiotic was doing its job. The blisters had disappeared and even tho still very swollen it was starting to heal. Recommended finishing up the antibiotic that Dr had put me on. It slowly improved and by 4/30/2021 was much better but never completely returned to normal. On 5/7/2021 it came back again..blisters, red and swollen. Saw Dr. on 5/10
54 2021-05-10 tingling, numbness, sensory loss Doesn't have any feeling in pinky; tired; tingling pinky/tingling hand; Left pinky was completely nu... Read more
Doesn't have any feeling in pinky; tired; tingling pinky/tingling hand; Left pinky was completely numb; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 21Apr2021 at noon, (Lot Number: EW0158; Expiration Date: 31Jul2021), as 0.3 mL single, for COVID-19 immunisation. Medical history included hyperthyroidism from Aug2013 and ongoing, illness anxiety disorder (grandmother), ongoing brain neoplasm, ongoing drug hypersensitivity, ongoing hypersensitivity (a lot of unspecified allergies). Concomitant medication included methimazole (unknown manufacturer) for hyperthyroidism from Aug2013 and ongoing. The patient experienced doesn't have any feeling in pinky (non-serious) on 21Apr2021 with outcome of unknown, tired (non-serious) on 21Apr2021 with outcome of not recovered, tingling pinky/tingling hand(non-serious) on 21Apr2021 with outcome of unknown, left pinky was completely numb (non-serious) on 21Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood test: unknown result (all the time for hyperthyroidism ), blood test: unknown result in Apr2021, diabetes mellitus: unknown result (two times), diabetes mellitus: 600 in Apr2021 (considered prediabetic), thyroid function test: slightly high on unknown date (but under control). Therapeutic measures were taken as a result of left pinky was completely numb and included rub and shook. Clinical course: within 10-15 minutes after vaccination the patient started to feel pinky tingling, then her hand started tingling. 30 minutes after the pinky, she started to have a tingly hand. She also felt tired. No follow-up attempts are needed. No further information is expected.
54 2021-05-11 weakness Pt waited 15 minutes, went to leave and made use of the public bathroom. When sitting, patient felt ... Read more
Pt waited 15 minutes, went to leave and made use of the public bathroom. When sitting, patient felt faint, weak, and dizzy. Pt reported this to leadership. VS were WNL. Pt was advised to wait another 15 minutes. Pt symptoms persisted for another hour and pt reported feeling unsafe to leave throughout this time. EMS was called at 1720 to assess pt. EMS arrived at 1725. After discussion with pt, pt decided to leave with EMS at 1748
54 2021-05-11 flushing Reported generalized edema on face and hands. She was noted to have some flushing. She called 911 an... Read more
Reported generalized edema on face and hands. She was noted to have some flushing. She called 911 and was brought to ED for treatment. She received IV fluids and antihistamine in the ER. She was discharged the next day and was presccribed an antihistamine for 5 days. She is fully recovered.
54 2021-05-11 muscle spasms Tenderness at injection site. Lasted 2 days. Muscle spasms periodically in right arm following injec... Read more
Tenderness at injection site. Lasted 2 days. Muscle spasms periodically in right arm following injection. Occurred approximately 10 times in the week following the injection.
54 2021-05-12 feeling jittery Cough Sinus pressure Sinus congestion runny nose jittery feeling
54 2021-05-12 tenderness Within a couple of days, my vision was blurry and I felt like there was something in my eyes. They w... Read more
Within a couple of days, my vision was blurry and I felt like there was something in my eyes. They were irritated and didn?t respond to allergy drops or artificial tears. Around 5/6/2021, I noticed a bump/swelling on my left eyebrow. It was tender, and continued to swell for days. Approx. 5/10 I noticed some other bumps on my face and forehead. I began to feel shooting pain into my scalp, and i would be awakened by the throbbing in my eye and brow.
54 2021-05-13 burning sensation, muscle spasms I had slight spasms and pulsating immediately at the site of the shot. About an hour or two later I... Read more
I had slight spasms and pulsating immediately at the site of the shot. About an hour or two later I had a slight burning up my arm from where the injection was. I developed a severe headache on the right side of my head the next day and it has continued on the second day.
54 2021-05-13 feeling hot 40 minutes post vaccine, client still present during post vaccine respite, cl described she began f... Read more
40 minutes post vaccine, client still present during post vaccine respite, cl described she began feeling generalized warmth and itching, denied feeling any oral or respiratory symptoms, NP observed cl was unable to stop scratching her arms, thighs, chest, and anterior chest wall was quite erythematous, lungs CTA, vital signs stable, though hypertensive in her reported normal range, 50 mg IM Benadryl administered, symptoms improved significantly, cl was monitored an additional 20 minutes after that, cl went to work where she works with a NP who "said she did fine the rest of the day."
54 2021-05-13 muscle spasms, tremor On the evening of February 8, I felt heaviness in my chest. I was very tired. Around 1:30 am (Feb. 9... Read more
On the evening of February 8, I felt heaviness in my chest. I was very tired. Around 1:30 am (Feb. 9), I woke up, shaking in bed. It was uncontrollable. I tried to get up to walk it off. My body started shaking even more. I felt as though I were having a stroke. To stop my shaking, I placed one hand over the other but that didn't work. I fell back into bed. I called 911. The person said my reactions were normal side effects. They refused to send an ambulance because they said I sounded fine. On May 9, 2021, I started cramping. I haven't had a period in over three years. On May 13, I started spotting. This morning (May 14), I woke up bleeding.
54 2021-05-13 nerve pain developed shingles 2 and 1/2 days after 1st Vaccine, went to banner urgent care on 4/23 because of r... Read more
developed shingles 2 and 1/2 days after 1st Vaccine, went to banner urgent care on 4/23 because of rash starting on 4/19 and was on left torso from belly button to spine left . started as small red bumps and progressed to. nerve pain /pressure all over left torso. diagnosed on 4/23 at as shingles. took anti viral for 7 days . (VAL?)
54 2021-05-13 pain in extremity, nerve pain, feeling of body temperature change 7-8 days after Pfizer #2 I started to have severe fatigue, and recurrent hot and cold spells accompa... Read more
7-8 days after Pfizer #2 I started to have severe fatigue, and recurrent hot and cold spells accompanied by arrythmia. Exercise intolerance and leg/nerve pain after mild activity (walking dog around the block for 15 minutes). Suppressed appetite.
54 2021-05-15 flushing At 16:16 voiced complaints of dizziness, palpitations, and hives. Attendee was flushed. Benadryl 50 ... Read more
At 16:16 voiced complaints of dizziness, palpitations, and hives. Attendee was flushed. Benadryl 50 mg administered by mouth. No shortness of breath and breathing normally. Not tachypneic. HR: 86 BP: 156/79 16:45 – Feeling much better. No longer dizzy. No palpitations. Not flushed. Hives not increased, so she was discharged to home. Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently with her husband. HR: 81 BP: 141/88
54 2021-05-15 pain in extremity, numbness Months after my arm that received the shot hurts hard to sleep on it hand goes numb over nught
54 2021-05-16 inability to speak Pt received vaccination on 05/13. The following day developed fever. On 05/15 she developed sore t... Read more
Pt received vaccination on 05/13. The following day developed fever. On 05/15 she developed sore throat and vomiting. Her sore throat progressed where she could not speak or talk. She was seen in the ER and in respiratory failure. She was intubated and developed septic shock. Labs notable for WBC 0.1, platelets 32. INR elevated at 2.2. She had renal failure and shock liver and evidence of DIC. Blood cultures grew gram negative rods. She eventually died from septic shock.
54 2021-05-16 pain in extremity Soreness in left arm for 2 days after injection. Woke up with Vertigo on 4/26/2021 and had to go to... Read more
Soreness in left arm for 2 days after injection. Woke up with Vertigo on 4/26/2021 and had to go to hospital for treatment. Symptoms lasted for 9 days after initial onset. I have had vertigo in the past twice before to the same degree so not sure if this is a side-effect to the vaccine.
54 2021-05-16 pain in extremity Soreness in arm (~48 hours); fatigue (~48 hours); slight fever and nausea day after injection.
54 2021-05-16 tremor, numbness Numbness in face, arms, legs. Tremors, Dizziness almost blacking out. Chest pains. Paramedics called... Read more
Numbness in face, arms, legs. Tremors, Dizziness almost blacking out. Chest pains. Paramedics called Blood pressure extremely low to very high. Taken to hospital. Events as such continue to occur. Have been to ER , Neurologist, Cardiologist, Primary Care.
54 2021-05-17 migraine Injection date: 05/03/21 Reaction date: 05/03/21 LOT: EW0161 EXP: 07/31/2021 Headache starting 2 hou... Read more
Injection date: 05/03/21 Reaction date: 05/03/21 LOT: EW0161 EXP: 07/31/2021 Headache starting 2 hours post injection. Hx of migraines. Severe HA with fevers and chills starting approx. 12 hours post injection and lasting only 8-12 hours. Followed up with patient 05/18/21 and she states she still has this persistent headache that started 2 hours post injection.
54 2021-05-17 tingling Day after the shot, marked notice of SOB, enormous chest tightening pressure, coupled with upper bac... Read more
Day after the shot, marked notice of SOB, enormous chest tightening pressure, coupled with upper back tingling, pressure down spine and in lower back during any kind of normal exertion: Walking the dog (could not go more than 1-2 houses without having to stop and catch my breath), walking 2 blocks from car to restaurant, walking home from a neighbor's house (normal 5 min walk) and climbing of stairs in home. Symptoms appeared to abate somewhat, but were still prominent "not right" - still winded climbing one flight of stairs. Had a telehealth appt with a Professional wrt Covid friday morning May 14 at 11; she called me directly at 8 am - concerned about my description and told me to go to ER. I went to ER at 10:30 that morning (May 14). They admitted me, ran an abundance of tests (EKGs, chest xray, full metabolic flood panel, echocardiogram, and resting stress test. Diagnosis is atrial fibrillation and atrial septic defect.
54 2021-05-18 bell's palsy Bell's Palsey of left side of face; This is a spontaneous report from a contactable consumer (patien... Read more
Bell's Palsey of left side of face; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 at 11:00 (Lot Number: EN6199) (at the age of 54-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included rheumatoid arthritis (RA), fibromyalgia, gastrooesophageal reflux disease (GERD) and high blood pressure, all from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 before vaccination and since vaccination has not tested positive to COVID-19. Concomitant medications included oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET); valsartan (DIOVAN); levothyroxine sodium (EUTHYROX); orphenadrine and quetiapine, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously took ALUPENT and ADVAIR. The patient experienced Bell's palsy of left side of face on 29Mar2021. The event required doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with steroids and antiviral. The patient outcome of the event was not recovered.
54 2021-05-18 pain in extremity After first dose experience muscle aches and joint pain with significant fatigue and sore arm for 1 ... Read more
After first dose experience muscle aches and joint pain with significant fatigue and sore arm for 1 week. After second dose mild sore arm at injection site, fatigue, and profound tinnitus bilaterally-has continued now for 4 months with no consistent improvement. Have not seen a provider or received any treatment for it. Question 21 should have an option for "Unknown" as I do not know if this will ever resolve or if it will progress with other neurological damage or disability. I plan on seeing my provider since it has not resolved and seems to be worsening
54 2021-05-18 pain in extremity Sore joints; hands, knees, hips
54 2021-05-18 pain in extremity Moderately sore arm; This is a spontaneous report from a non-contactable consumer. A 54-year-old fem... Read more
Moderately sore arm; This is a spontaneous report from a non-contactable consumer. A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in right arm on 09Feb2021 as single dose for COVID-19 immunisation. The medical history of the patient included blood Pressure, thyroid. The patient's concomitant medications include unspecified medications for blood pressure, thyroid. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 2021 the patient experienced moderately sore arm on an unspecified date. The event was considered as non-serious. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
54 2021-05-18 tingling, numbness interment tingling/numbness in my arms & legs: primarily toes to knees & fingers to elbows, although... Read more
interment tingling/numbness in my arms & legs: primarily toes to knees & fingers to elbows, although not exclusively. It hasn?t been all limbs at the same time & is primarily my right hands, arms, feet, legs. This began several hours after shot and more frequent and pronounced over coming days. It comes and goes but to date (5/19) haven't had a day without this. As a note, I had a similar reaction to the TDaP vaccine, and although the symptoms abated over time, it took months for them to completely go away. Add?l side effects: extreme exhaustion like feeling drugged day of shot; this changed to very tired the following day and then to typical tiredness. dry mouth/extremely thirsty day of shot & into next day (I had hydrated leading up to shot) vaccine site warm to touch for several days diarrhea on day 3 occasional nausea headache
54 2021-05-18 tingling tingling in left leg along with swollen ankles
54 2021-05-19 slurring sick; not feeling well; I had a feeling of "intoxication", which included sporadic slurred speech an... Read more
sick; not feeling well; I had a feeling of "intoxication", which included sporadic slurred speech and heaviness in legs and feet.; I had a feeling of "intoxication", which included sporadic slurred speech and heaviness in legs and feet.; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration on 24Mar2021 at 12:45 PM (at the age of 54-year old), as 2nd dose, single, in right arm for COVID-19 immunisation and received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via an unspecified route of administration on 03MAR2021 at 16:45 (at the age of 54-years old) as 1st dose, single in right arm for COVID-19 immunisation at Workplace clinic. The patient's medical history included uterine cancer and bipolar 2. Concomitant medications received within 2 weeks of vaccination included oxycarbaxepine, alprazolam, quetiapine, lorazepam, D-amphetamine, vitamins D3 and biotin. Patient had no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, approximately 7 hours following vaccination, the patient had a feeling of ''intoxication'', which included sporadic slurred speech and heaviness in legs and feet. Symptoms resolved within 24 hours. After first vaccination, patient had a feeling of ''euphoria'' SUPER HUMAN and was able to complete very difficult CrossFit moves in the gym, which she was never able to complete for the past 6 years. First vaccine event was not reported because it was a positive event and not an adverse event, but now patient wondered if there was a connection between her reactions to both vaccines, or possibly an interaction with her concomitant medications. There was no treatment received for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Upon FU received on 06Apr2021, patient reported to be too sick and upon FU received on 09Apr2021, patient reported that he was still not feeling well, but still alive. No follow-up attempts are needed. No further information is expected.
54 2021-05-19 difficulty speaking Approximately 15 minutes after receiving vaccine, patient began to complain of a deeper sounding voi... Read more
Approximately 15 minutes after receiving vaccine, patient began to complain of a deeper sounding voice than usual. Patient states that she did not have any difficulty breathing or swallowing. Patient stated that her eyes were watering also. EMS called. Initial blood /pressure of 134/87. Five minutes later, blood pressure was 152/84. Patients eyelids began to swell. Patient still not having any difficulty with breathing or swallowing. EMS arrived on site less than 10 minutes after patient began having symptoms, patient taken to hospital.
54 2021-05-19 tingling, numbness right cheek numb, left cheek numb, front neck numbness. Right arm injection site, still has pain wit... Read more
right cheek numb, left cheek numb, front neck numbness. Right arm injection site, still has pain with movement. Right arm , mid spine and right leg intermittent paresthesias. Brain fog
54 2021-05-21 weakness Day 1 (day of shot) - within 90 minutes, started experiencing eye strain/sensitivity to light and c... Read more
Day 1 (day of shot) - within 90 minutes, started experiencing eye strain/sensitivity to light and chills (without fever) Day 2 - Intense chills, fever (high 101.7 but my baseline is only 97.5), body aches, fatigue, brain fog Day 3, - fatigue. blurred vision, nausea (as a result of trying to read with blurred vision), random pains in body (sciatica-like pain in both legs, kidney pain, liver pain, chest pain), brain fog, lack of stamina. Day 4 (today) - leg pain, brain fog, blurred vision (particularly in left eye), eye strain, sensitivity to light, lack of stamina, sensation of swaying when standing up/standing still
54 2021-05-23 hot flush I am post menopausal. I have not had hot flashes consist for over a year After the vaccine the ho... Read more
I am post menopausal. I have not had hot flashes consist for over a year After the vaccine the hot flashes returned severe again
54 2021-05-23 hot flush 10 mins post, severe syncope, and headache, severe ringing in ears * Severe headaches every morning ... Read more
10 mins post, severe syncope, and headache, severe ringing in ears * Severe headaches every morning * continued moderate ringing ears * Severe dehydration every morning * Frequent heartburn * lungs tight, a bit shallower breathing * Vertigo all day and night * Chills and hot flashes but no fever * Nausea every morning until I eat; have to eat every few hours to avoid nausea * random dry raspy cough * 100+oz. H20 daily+powerade(S/F)p * urine near clear by afternoon * using RR 3x/night, but avg 5a wake-up with severe headache & PARCHED with very dry mouth
54 2021-05-23 numbness, tingling Numbness and tingling and left leg and foot approximately 6 hours after the vaccine. Joint pain in b... Read more
Numbness and tingling and left leg and foot approximately 6 hours after the vaccine. Joint pain in both knees approximately 12 hours after the vaccine making it difficult to descend stairs. Over the next several weeks joint pain increased to include both hands, wrist, elbows, shoulders, ankles and feet. The pain has increased, mobility and ability to do everyday tasks is greatly impaired.
54 2021-05-23 pain in extremity, numbness Pain of the right bicep muscle that has worsened with time. Seemed to be getting better but flared r... Read more
Pain of the right bicep muscle that has worsened with time. Seemed to be getting better but flared recently again. Note that the pain never fully went away, it just seemed to be intermittent. As of last week, pain started to increase again, especially when raising arm while extended, with weakness and slight numbness of hand. Responsive (but not fully anymore) to NSAIDs. Didn?t seem to be the shoulder/bursa related issue but now unsure. Painful to extend arm and lift objects is bad enough that I am finally reporting it. I mentioned this problem to my PT when it occurred and he can corroborate that I have complained of it again at my last visits. I?m already in pain from my leg and find this additional complication most unfortunate. It seems to me that the national guardsman injected my muscle too deeply. I actually thought I heard him say ?oops? at the time, but I?m not sure. I didn?t think much of it because muscle soreness for a period is normal, but when it hadn?t gone away by my second vaccine I actually asked them to go easy on me because my arm was still sore from the first vaccine. They took note of that and were quite gentle. They also had to give me a new vaccine card, because the guy who stabbed me spelled my name wrong etc. on the first card.
54 2021-05-23 pain in extremity Soreness down the arm when administer, toes tingled, later that day sore all over , felt very tired... Read more
Soreness down the arm when administer, toes tingled, later that day sore all over , felt very tired and felt like sleeping. Still feeling sore all over after a few days.
54 2021-05-24 weakness Flu like symptoms. Chills. Stuffy head. Weak. Sore throat
54 2021-05-24 numbness Patient reported nausea for 2 days beginning immediately after dose and feeling of lack of circulati... Read more
Patient reported nausea for 2 days beginning immediately after dose and feeling of lack of circulation in her right hand beginning day after vaccine and lasting 2-3 hours. Patient described right hand/ finger felt numb and exhibited bruising on her right middle finger and below her fingernail.
54 2021-05-24 pain in extremity The first shot had sore arm for 24-36 hours. I didn't feel it go in. The 2nd shot was jabbed in a... Read more
The first shot had sore arm for 24-36 hours. I didn't feel it go in. The 2nd shot was jabbed in and immediately hurt. Within a few hours I had a sore arm w/very limited mobility. My shoulder range of motion is still affected. This is not a big deal but it's a similar reaction to tetanus shot. I couldn't even put on my coat with the tetanus reaction; this one isn't that bad. It was probably a year before that resolved. So, I don't know if it's my anatomy, how it was administered, or both. Essentially, I can still "feel" the spot on my arm and in some range of motion. I'm very grateful for the vaccine and would do it again. Just wonder if the similar tetanus/COVID vaccine is something to look at.
54 2021-05-24 tremor While sitting in observation post vax, at 4:15 PM, pt states that she felt anxious and took her own ... Read more
While sitting in observation post vax, at 4:15 PM, pt states that she felt anxious and took her own personal dose of ativan 1 mg. Pt had visual shakes and slight diaphoreses. Assessing RN gave 1 bottle of water. HR 119, 02 sat on RA 99 %. Pt remained anxious, husband at side. After a period of 15 min, pt requested RN to call 911. Charge Nurse notifiedn911 w/ current BP of 190/100 at 4:28 PM. Pt remained alert until arrival of EMS for transport to Medical Center. Husband remained w/ client for transport. Gave care to EMS at 4:45.
54 2021-05-25 bell's palsy ?Pfizer-BioNTech COVID-19 Vaccine EUA? Took my first shot on 4/16/21 and on 5/8/21 symptons started ... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? Took my first shot on 4/16/21 and on 5/8/21 symptons started and on 5/9/21 was diagnosed with having Bell's Palsy on the right side of my face. Doctor advised not to take my second Pfizer shot on 5/11/21 until recover which could take up to 8 weeks or longer.
54 2021-05-25 feeling hot, tremor I received my 2nd vaccine on Thursday, May 20th. Within hours after receiving my 2nd vaccine, my han... Read more
I received my 2nd vaccine on Thursday, May 20th. Within hours after receiving my 2nd vaccine, my hands began to shake, I was very hot with persistent sweating. I never ran a fever. I felt heart palpitations. I experienced extreme nausea, but did not vomit. I had 2 episodes of diarrhea. My head felt very "heavy". When I stood up to walk my gait was very unsteady and I could not walk straight. I was unable to sleep. I followed the advice of the nurse who administered the vaccine - she informed me that I may experience symptoms for 24-48 hours after the shot. For that length of time, I did nothing about the symptoms, assuming they would go away. However, the symptoms persisted (except for the diarrhea) without subsiding until Monday, May 24th. I contacted my primary healthcare provider via patient portal. She was concerned about the length of time I was experiencing such extreme nausea . She felt that I may have been dehydrated and told me to go to the ER. I was admitted to the ER. A chest x-ray was taken. Blood work was taken, urinalysis was conducted, IV fluids with anti-nausea medications and Benadryl were administered. I was discharged from the ER after several hours with minimal symptom relief
54 2021-05-25 numbness, tingling Vibration (feeling of cell phone vibrating) throughout my entire body, my right jaw has locked and ... Read more
Vibration (feeling of cell phone vibrating) throughout my entire body, my right jaw has locked and painful, I have a constant headache, eyesight worse (blurry even with glasses), all over constant body throbbing, stomach issues (sharp pains and cramping), constant numbness (the feeling of when you rub your skin when the novocaine is starting to wear off after a dental procedure) from my feet up to my waist and the feeling of pins and needles (like when you hand is asleep) from my feet up to my pelvic area. This all started with just a small vibration in my right hip and has increasing gotten worse over the last several months.
54 2021-05-25 pain in extremity, migraine Pain and weakness in arm for almost 5 days. vertiginous migraine started within 12 hours, and laste... Read more
Pain and weakness in arm for almost 5 days. vertiginous migraine started within 12 hours, and lasted four weeks and three days, 24 hours a day, This is the longest vertigo episode I have had in my life ( longest was 3 weeks). Prior to this, I had not had a vertigo episode for over a year! It made me exhausted and I had a few headaches from the vertigo itself. There is no effective treatment for it. After two weeks, I decided to try an essential oil blend- topically and internally, which I made specifically to manage vertigo. Internally, I placed frankincense on the roof of my mouth and took Zendocrine blend supplements. This all helped significantly, yet this major vaccine side effect lasted incredibly long. I could not work, drive, or walk safely. I heard that for some people, the vaccine triggered underlying illnesses or "weak spots." I figured that's what happened to me. Last day of vertigo was May 14. It took another week to bounce back, still felt pretty tired until May 21. Finally think I am recuperated. For the first vaccine, I had a major migraine within 24 hours, arm pain for 3 days, and needed a nap in the middle of the day. It was very mild and easy compared to the second vaccine dose. Prior to vaccination, I called my PCP and MCS, and both Doctors told me I was cleared to take the vaccine, and did not think I would have any issues with it.
54 2021-05-25 seizure 'seizes'/seizure; This is a spontaneous report from a contactable consumer (patient). A 54-year-old ... Read more
'seizes'/seizure; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 31Mar2021 at 13:00 (at the age of 54-years-old) as 1st dose, single (Batch/Lot Number: ER8732), via an unspecified route of administration, administered in arm left for COVID-19 immunisation. Medical history included coconut allergy from an unknown date and unknown if ongoing. Concomitant medications included topiramate and triamterene, both taken for an unspecified indication, start and stop dates were not reported. Between 31Mar2021 and 21Apr2021 (reported as Apr2021), the patient had a total of 10 'seizes'/seizure. Before, he had 2 to 4 'seizes' within a three months' time. The patient received the second dose of BNT162B2 on 21Apr2021 at 13:00 (Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm left for COVID-19 immunisation. There was no treatment received for the event. The outcome of the event was unknown. Information about lot/ batch number has been requested.
54 2021-05-26 numbness 1st dose of bnt162b2 on 03Feb2021/ 2nd dose on 18feb2021; Start Date/Time:18Feb2021 01:00 PM; Start ... Read more
1st dose of bnt162b2 on 03Feb2021/ 2nd dose on 18feb2021; Start Date/Time:18Feb2021 01:00 PM; Start Date/Time: 03Feb2021 12:45 PM; numbness came back stronger from head to toe; feel sizzy; not very well; severe allergy; severe allergy sneezing; headache; full body numbness; This is a spontaneous report from a contactable consumer (reporting for herself). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 13:00 (Batch/Lot number was not reported) as 2NDDOSE, SINGLE for covid-19 immunisation. Medical history included gall bladder removed, kidney stones and hysterectomy. concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 03Feb2021 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks. The patient not received other medication within 2 weeks. Prior to vaccination, the patient was not diagnosed with covid. Post vaccination, the patient not tested for covid. The patient was vaccinated with second short after 5 hours full body numbness occurred on 18Feb2021. By next morning it was gone. On 19Feb2021 then severe allergy sneexing and headach that I have never had before it took 3 antihistimines to settle it down some. On 20Feb2021 to 22Feb2021 feel sizzy at times and not very well. On 23Feb 2021 numbness came back stronger from head to toe. I am in emergency room now and they gave me steriods and are checking my blood. The events was assessed as serious (medically significant). Treatment was received for events. The outcome of the event body numbness was recovered and remaining all events were not recovered. Information about lot/batch number has been requested.
54 2021-05-26 pain in extremity, weakness Hives forming on face near ears; itchy skin on arms and legs; Tired; weak mildly achy limbs; weak mi... Read more
Hives forming on face near ears; itchy skin on arms and legs; Tired; weak mildly achy limbs; weak mildly achy limbs; cognitively slower; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 11Mar2021 13:00 (at the age of 54-years-old) as a single dose for covid-19 immunization. Medical history included dry inflamed eyes and MGD of eyes (Meibomian gland dysfunction), thyroidectomy, thyroid cancer, pulmonary sarcoidosis, lymphedema and hypertension. The patient previously took ciprofloxacin and experienced drug hypersensitivity and food allergy (sulfa drugs, tree nuts, raw orchard fruits). Concomitant medication(s) included levothyroxine, liothyronine, losartan, clonazepam. The patient had no other vaccine within four weeks. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 11Mar2021 21:00, the patient had hives forming on face near ears, itchy skin on arms and legs, tired, weak mildly achy limbs, cognitively slower. The patient received treatment for the events. Outcome of the events was not recovered, at the time of this report. No follow-up attempts are Possible. Information about lot/batch number cannot be obtained.
54 2021-05-26 pain in extremity Vomiting; Headaches; Sore arm; Nausea; This is a spontaneous report from a contactable consumer, the... Read more
Vomiting; Headaches; Sore arm; Nausea; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unspecified age received BNT162B2(Phizer- BioNTech/EP7534) (lot no: Unknown) solution via injection via an unspecified route of administration for Covid 19 immunisation on 15Mar2021. The patient's medical history included Chronic obstructive pulmonary disease (Copd), depression, anxiety, post-traumatic stress disorder (ptsd)and bipolar 1. The patient's past drug history included Bactrim which had caused drug allergy. The patient was not pregnant at the time of vaccination and has not had symptoms associated with COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 16Mar2021, the patient experienced Nausea, headaches, vomiting and sore arm. No therapeutic measures were taken for the reported events. The clinical outcome of the events was unknown at the time of reporting. No follow up attempts are needed, information about batch number cannot be obtained.
54 2021-05-27 numbness After waiting the required 15 minutes left the pharmacy. About 10 minutes later while driving my ent... Read more
After waiting the required 15 minutes left the pharmacy. About 10 minutes later while driving my entire left arm including my hand became numb and my tongue and back of my throat felt like it was swelling. I was close to an ER and went there. They took my blood pressure and sent me back to the waiting room. I was not comfortable waiting as I was having difficulty breathing and was scared so I left and picked up Benadryl and took 50 mg immediately.
54 2021-05-27 tingling PATIENT WAS FINE IMMEDIATELY AFTER. ABOUT 13 MINUTES LATER, SHE CAME TO RPH ASKING IF GOOSE BUMPS A... Read more
PATIENT WAS FINE IMMEDIATELY AFTER. ABOUT 13 MINUTES LATER, SHE CAME TO RPH ASKING IF GOOSE BUMPS ARE NORMAL. SHE SAID HER SKIN WAS MORE PINK THAN NORMAL, WHICH RPH COULD NOT SEE. SHE STARTED HAVING TINGLING DOWN THE ARMS AND LEGS AT APPROX 15 MINUTES. HEADACHE STARTED SHORTLY AFTER. NO ITCHINESS, INCREASED HEARTRATE OR RESPIRATORY DISTRESS. 17 MINUTES, PATIENT STATES HER FACE FEELS LIKE A TIGHT MASK. 911 CALLED. PATIENT IS COMPLETELY RESPONSIVE AND CALM, BUT CONCERNED. 32 MINUTES, MEDICS ARRIVE AND TAKE VITALS. BP IS ELEVATED, PULSE OX NORMAL, LUNGS ARE NORMAL. MEDICS STATE THERE IS NOTHING LIFE THREATENING AND PATIENT MAY GO TO THE HOSPITAL IN AMBULANCE OR WITH HER CHILDREN IF SHE WANTS TO. PATIENT WALKS TO FRONT OF STORE SAYING HER FACE WAS SWELLING.
54 2021-05-27 trigeminal neuralgia Since my first vaccine , I have had sudden sharp left temple pain lasting 5-10 seconds. I have never... Read more
Since my first vaccine , I have had sudden sharp left temple pain lasting 5-10 seconds. I have never in my life had this type pain . No rhyme or reason to when it happens . It became progressively more frequent slowly over next 4 months . I went to see my PCP on May 11 because I could not ignore this any longer because was happening now multiple times per day . Pcp believes it is either temporal arteries or trigeminal nerve irritation. Since it is sudden sharp pain ...they are treating me with gabapentin for 1 month to see if it is resolved . It is helping . Only have pain now 2-3 times per week which is so much better . My concern is I have never had this before and started after vaccine for covid . I have had both vaccines now because I am an RN .
54 2021-05-28 weakness heavy headache; 101.7 fever; Muscles were burning, exactly like when she had COVID/muscle aches/Whol... Read more
heavy headache; 101.7 fever; Muscles were burning, exactly like when she had COVID/muscle aches/Whole muscle ached and could barely move from the pain; back heavy; could not move; has no strength; can barely walk; She was sick from getting the shot; she got so sick, it looked like COVID started all over again; felt a little bit dizzy; chills; tired; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the right arm on 29Mar2021 at 16:45 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient wanted to know if she should get the second shot. She previously had COVID by the end of December. She was really sick with COVID, so then she signed up for the vaccination, and had the first dose last Monday, 29Mar2021 at 4:45PM, and then around 6:00PM, she felt a little bit dizzy, she exercised herself and went to bed. Dizziness started on 29Mar2021 and ended after she worked out. The patient stated she felt better from like the bloodstream from the workout, that helped. The patient said it ended around 7:00PM that day. In the morning (30Mar2021) around 5:00AM, her whole muscles ached, and she could barely move from the pain. It was reported that she got so sick from getting the shot, it looked like COVID started all over again, it was that heavy. Her back felt heavy, she could not move, her muscles were burning, exactly like when she had COVID. She had a heavy headache that she had to take a drug; normally, she never takes drugs, she reacts very fast. On 30Mar2021 evening, it was unbearable at 9:00PM, so she took Diclofenac, the pill form of Voltaren and that helped and one hour later at 10:00PM, she got rid of the headaches and got rid of the 101.7 fever. With the fever, she took it an hour ago, it was 98, which is higher than normal. Her temperature is always 97.3, so it's a little bit higher than normal. The patient said she still has no strength, and she can barely walk which started on 30Mar2021 and ongoing. She has been bad the whole time, but it has improved. She said she could barely open her eyes and she could not hold the phone the day before, but that day (31Mar2021), she can hold the phone with Pfizer. In Mar2021, the patient had chills and felt tired. She was thinking she should report this to Pfizer Drug Safety. She stated the CDC recommended to go for the vaccination 10 days after having COVID, and it's been three months. She said that she is still in bed that day (31Mar2021), she cannot walk. She described the side effects with the first dose of the vaccine as severe. Also, she was very sick with Covid by the end of December. She said she is a vaccine promoter, she is really standing behind it and she is the only one who got sick, not her friends or anybody else. The patient stated she doesn't have a doctor, and this is the first time she was really sick since December. The patient verified that she is speaking of the Pfizer BioNtech Covid Vaccine. The patient also believed that this reaction came because she was so sick with COVID in December. She stated she already had the antibodies and thinks she was too early for the vaccination. She was unsure if she wanted to proceed with the second dose of the Covid vaccine as she had a prior Covid infection in Dec2020. She said nobody can tell her, the second vaccination was on 19Apr2021, exactly three weeks, and she was asking what she should do. She would like to know what the second dose of the Covid vaccine does. She has talked to doctors and they don't really know. She asked whom she could ask, and what they would recommend on what she's doing with the second one. She said nobody can tell her, and the CDC Broward told her she should call 911 and she said absolutely not, she is not going to the hospital, she has never been and she's not going, and nobody can answer her. She does not believe the CDCs recommendation to receive the Covid vaccine 10 days after a person tests negative is a good idea. She said the doctor has no idea, new to the whole thing and one doctor said that he's never had any patient who had gotten sick after the first dose, he did not see that before, and this was the first time. She said she would love to talk to someone in research or something who would say yes, she can go, or would strongly recommend going. She said that at the very end, she makes the decision for herself, she would just like to hear from somebody who knows what they are talking about. No relevant tests were done. The events muscles were burning, exactly like when she had COVID/muscle aches/whole muscle ached and could barely move from the pain, back heavy, could not move, can barely walk, has no strength were resolving. The event felt a little bit dizzy resolved on 29Mar2021 at 19:00 (7PM), and the events 101.7 fever, heavy headache resolved on 30Mar2021 at 22:00 (10PM) while the outcome of the rest of the events was unknown. None of the adverse events required a visit to the Emergency Room or Physician Office. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
54 2021-05-28 cold sweat The day following vaccination, I was doing doing light yard work, came in the house, got a drink and... Read more
The day following vaccination, I was doing doing light yard work, came in the house, got a drink and it got caught in my throat, I sat down in a chair and woke up on the floor( presuming I had passed out.) I was out for a few minutes. When I awoke I was disorientated and had suddenly a headache, nausea, sweaty and clammy skin.
54 2021-05-28 feeling cold, feeling hot Next day felt like flu symptoms hot/cold took Tylenol went to bed, next day felt better but now arm ... Read more
Next day felt like flu symptoms hot/cold took Tylenol went to bed, next day felt better but now arm red, sore, hot to touch and swollen/ lump at injection site. Also lump under armpit/sore, applied ice & took ibuprofen, next day arm still ref/hot/lump, armpit still sore, but less of a lump.
54 2021-05-28 muscle spasms Headache; muscle soreness; cramping/diarrhea; fatigue; sight injection pain; cramping; This is a spo... Read more
Headache; muscle soreness; cramping/diarrhea; fatigue; sight injection pain; cramping; This is a spontaneous report from a contactable consumer (the patient). A 54-Year-old non-pregnant female patient received first dose bnt162b2 (Pfizer's COVID-19 vaccine, Solution for injection (Batch no: not reported, expiration: not reported), via an unspecified route of administration on Right arm on 27Feb2021 at 11:30 AM at single dose for covid-19 immunization. The patient medical history include neuropathy. The concomitant medications include Gabapentin, Eliquis, CBD/THC, Bariatric Vitamins. Patient was allergic to PCN, Demerol, Percocet, Iodine, latex, Tetanus. Patient did not have covid prior vaccination. Patient had not tested covid post vaccination. Patient did not had other vaccine in four weeks. On 27Feb2021 at 04:00 PM, the patient experienced headache, muscle soreness, cramping/diarrhea, fatigue and sight injection pain. The outcome of the events was recovering. No follow-up attempts are possible. Information on the batch/lot number cannot be requested.
54 2021-05-31 nerve pain, tenderness, tingling, feeling hot, pain in extremity - Teeth nerve pain - Extreem thirst - Swelling and warm hands and feet and aching - Ear pain and ti... Read more
- Teeth nerve pain - Extreem thirst - Swelling and warm hands and feet and aching - Ear pain and tinnitus and muffled sound (hearing loss) - Neck pain - Lower Back pain (4/19) - Middle back pain - Hiccups - Dry leathery skin (skin around fingernails and toenails peeled, hang nails (toes and fingers), lips cracked peeled overall skin looked dry wrinkled) no amount of oil or lotion helped. - Mouth painful blisters in the back that never popped just went away - Narcolepsy like tired episodes 35 minutes after vaccine 2x since - Dizzy when standing (evening of vaccine) - Knee patella dislocated and both knees seem unstable like they are going to dislocate entirely when leg is twisted like turning. - Tender to the touch and pain under left rib cage 4/13/21 one episode of narcolepsy weird tire episode that lasted a total of maybe 10 minutes with complete waking up just as I laid down to nap. Right arm hurt but not bad. Chills with a temperature of 97.1F and later was drenched in sweat with a temperature of 97.8F. Woke up super thirsty and was so thirsty for several days drinking 1.5 gallons of water and still being thirsty even when I tried some salt pills. 4/16/21 Really red, swollen and itchy eyes (allergies) with sinus headache 4/17/21 lower back went out slowly all day till I was stuck in bed with ice. Right arm tingling like pins and needles. Lips super dry cracking and peeling. 5/14/21 started prednisone
54 2021-05-31 pain in extremity chills; Nausea; Backache; fever/low grade temp of 99.5; took her temperature and measured 99.6F; sta... Read more
chills; Nausea; Backache; fever/low grade temp of 99.5; took her temperature and measured 99.6F; stated that she has been really fairly ill/being sick; metallic taste; mild soreness in her arm; This is a spontaneous report received from a contactable Consumer(patient) via medical information team. A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 27Jan2021, after 15 minutes of vaccination, the patient experienced having a metallic taste and mild soreness in her arm. On 29Jan2021, the patient ended up being sick at work, stated that she was been really fairly ill experienced chills, nausea, backache, fever. She took alternating dosages of Advil and Tylenol as prescribed by her doctor. Right now, she took her temperature and measured 99.6 F. She mentioned that she normally had low grade temperature 99.5 F in temperature. She was curious if the response was from the vaccine. The patient wanted to know if it would continue longer or may be something else. Stated that she was fine. Stated that anytime she was put under anesthesia that she gets sick. No further details provided. Does not know if what in the vaccine is similar to that. Wanted to know if she was good to go. Stated that she assumed it was a response but wanted to double check before she goes into work tomorrow. Wanted to know how long the response would last. Later clarified that it was for the Covid vaccine. Outcome of the events was unknown.
54 2021-05-31 cold extremities Itching across chest from left to right arm (within 10-15 minutes of vaccine) moved down right arm, ... Read more
Itching across chest from left to right arm (within 10-15 minutes of vaccine) moved down right arm, around ankles, up the back of neck on the right all within about 20 minutes. Dizziness, inner ear itchiness, stabbing in right front chest to the back, hands ice cold and very pale all over within 30 minutes. No hives anywhere. Liquid Benadryl, double dose administered about 15 minutes in, held in mouth for about 20 seconds before swallowing. Of course panic set in, focused on slow, deep breaths, outer ear itchiness and neck all around my neck. Called ambulance while pharmacist observed me on the floor laying down. Ambulance assessed BP was high, oxygen was 100%, started feeling better, dizziness stopped and itching almost gone, within an hour of Benadryl dose. Family member drove me home. Released from ambulance, not taken to ER or Urgent care.
54 2021-06-01 involuntary muscle movements Headache; swelling at injection site; vomiting; fever; coughing; muscle soreness; wicked nauseous; j... Read more
Headache; swelling at injection site; vomiting; fever; coughing; muscle soreness; wicked nauseous; jerking her body; She had the bathroom problems with her stomach; She was tired; her head was hurting; chills; This is a spontaneous report from a contactable consumer (patient herself). This is the case 1 of 2. A 55-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6208/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 16Mar2021 (at 55-years age) as 1st dose, single for covid-19 immunisation. The patient Medical history included cardiac failure congestive from an unspecified date in Nov2020 to an unspecified date (they hospitalized her for, and she had never been hospitalized other than to have a C-section for her beautiful baby), migraine from an unknown date and unknown if ongoing (she got when she was in college at around 20 age but not exactly specified, she has had those for a while but they tried all kinds of medicine that did not work so they did Botox and it worked), asthma from an unknown date and unknown if ongoing (diagnosed 4 or 5 years), immune system disorder from an unknown date and unknown if ongoing, dental operation from an unknown date and unknown if ongoing and surgery from an unknown date and unknown if ongoing. The patient Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE; dose: 25 mg, daily) taken for fluid retention, hypertension, start and stop date were not reported (no high blood pressure seen), vitamin d nos (VITAMIN D NOS; dose: 1000 UNK) taken for an unspecified indication, start and stop date were not reported (it was reported that the doctor did not know if she should take this the week before. No additional details provided), pantoprazole (PANTOPRAZOLE; dose: 40 mg, daily) taken for gastrooesophageal reflux disease, start and stop date were not reported, salbutamol (ALBUTEROL HFA; dose: 90 ug) taken for asthma, start and stop date were not reported, botulinum toxin type a (BOTOX; dose: every 3 months) taken for migraine, start and stop date were not reported (Patient had went to neurologist and they put needle in head, neck, temple, back. No additional information provided; Immunoglobin start and end date not specified) and furosemide (LASIX [FUROSEMIDE]; dose: 20 mg, daily) taken for cardiac failure congestive from an unspecified date in Nov2020 to an unspecified stop date. The patient experienced swelling at injection site, vomiting, fever, coughing, muscle soreness, wicked nauseous, jerking her body, she had the bathroom problems with her stomach, she was tired, her head was hurting, chills on an unspecified date in Mar2021 and headache on 16Mar2021. Patient had taken both vaccinations 3 weeks apart and she had reactions and was looking at paperwork. The reactions said to update. She called the first number to update, and they said they are mailing her a form to update at the CDC/FDA address reporting system and then there is also a number to call Pfizer as well with a telephone number. Most of her side effects were listed and the swelling for bigger day by day. Caller adds that she wants to say she had vomiting on both vaccinations. She has immune deficiency. She threw up the first time, for four days, and thought she ate something bad. For 24 to 48 hours, she threw up again after both vaccines for four days. Physician or primary caller stated she did not give her the actual vaccine. She had not been dealing with her physician and if she gave it to her, then she would give this information but she went to a different location to get the shot. She called 211 because her doctor's office was trying to make her wait a long time. Caller waited to call Pfizer because she was trying to feel better. She forgot to call. She was going to call during her symptoms but pulled out the pages of symptoms and most are normal. She called urgent care and talked to them and they said if she could not stop throwing up or was dehydrated and could not keep anything down then to call back in 24 hours because it could be a stomach bug or anything. She waited it out to get better and finally it did. The headache started immediately, the whole 15 minutes she was waiting. It was worse and worse. She could not wait to leave and take Tylenol. It ended up going away, but it took a while. It was so bad for about a week on both shots. Throwing up, redness and swelling at injection site: first one she had some swelling, it got a lot more red and swelling then at the second. She does not know why it was there and got bigger and bigger. The throwing up started within 48 hours of getting the vaccine. When she went to sleep, it started. She was wicked nauseous and tried not to throw up for hours. She stopped drinking but still threw up even though whatever was in her stomach. She violently threw up for days and could not stop it was horrible. After the first and the second vaccine. Anything she ate her 14-year-old ate too, they had the same meal, they would have both gotten sick from it if it was just a bad meal. It stopped, and she thanked God, but it took 4 days the first time she just kept throwing up and trying to sleep to not throw up. Her son asked if she was okay and wanted drinks, so she put a drink in the freezer to soothe her throat and not throw up. Everything in her stomach came up. The second day, it was more bile no more food left. She stopped drinking the first day and did not want to get dehydrated. She went between water and soda. Her son was worried and wanted to know if she should call the doctor, but she called and they cannot do anything and would rather her not come in if she had symptoms and that if she does not get better to go to the ER. She would sleep, wake up, and grab bucket right away. She did not even make it to the bathroom she was throwing up so violently. Headache, vomiting: It was not projectile across room but every time she would when she was throwing up really bad, going pee. As soon as she woke up, she does not know if it was that she had to throw up, so she woke up. She was tired, her head was hurting. She could not keep medication down. The second day, she realized it was the 3rd morning. She knew if she couldn't keep it down, she would have to go to the emergency room, so she stopped drinking completely and tried not to throw up. Her headache got better, not worse, but the throw up continued. She kept going to sleep. Fever and chills: she did have fever and chills; she does not know if from throwing up. That started the 2nd day after both vaccines, and it happened both times which is why she knows it was the vaccine. Redness and swelling at injection site: the first time, very small amount the size of a dime. The second time dime the day it happened and much sorer, it got bigger and bigger. The size of a nickel, then quarter, then half dollar. Coughing, muscle soreness: She was trying to write down her symptoms but was so sick. She had the bathroom problems with her stomach, coughing but that was from throwing up. Soreness in muscles was like from throwing up and jerking her body. She does not know if it has to do with that or from her body. No additional details provided. Indication: she as immune deficiency, low IgG she is diagnosed with for now. She did not want to catch it and die. She heard discrepancies; she wants her 14-year-old to get it. She wants to live for her 14-year-old. She heard it was approved for 14-year-olds but her 14-year old's primary doctor is not acknowledging this and said over 18, but she heard 16 and over, and then now 12 to 16. Caller wants to know if a 14-year-old can receive the vaccine. Lasix: in Nov2020, they gave her Lasix. She was given 20 mg Lasix. She was in the hospital for Congestive Heart Failure which is fluid build-up around the lungs which was watery tension. She was admitted into the hospital for Thanksgiving. Since hospitalized, she has never had a problem. One pill daily. Hydrochlorothiazide: caller states this may have been from sickness or illness, they gave her this for high blood pressure and water retention. They called it HCTZ or something. Lasix: caller states she was on the generic for Lasix, she took both. The other is called Furosemide 20 mg and she took them both as a fluid pill just the manufacturer changed. She changed it to Lasix 20 mg. They gave generic she guesses. PSCC Communication: medication left as Lasix as caller states this is the one, she was currently taking. Pantoprazole: stomach medicine, interchanged for Protonix. Her stomach gets really upset, they said she had GERD and it bubbles sometimes when she lays down long period of time like at night. When she was throwing up, for a few days, she could not stay down for long. It kept coming up. She would eat saltines, jello, anything. The third day she finally stopped throwing up at night that morning or night on the 4th day she tried to have anything jello, cracker. The threw up day and night. Thank god she is feeling better. Immunoglobin: caller states the last one is for low IgG, immuno deficient. She just found out about this two years ago. She used to get Hyvantera subvQ. Caller confirms spelling and states she thinks that was what it was called. It went into the fat places. Then, they started doing IV. She does not know; she thinks the new one she gets now is called immunoglobin and the nurse comes once a month to do an IV infusion for it. She did get that, approximately week to ten days before the first vaccine. Caller states she can only get it, maybe, she can't remember, every 3 months so she does not have to go for another one. Caller then states she is not sure if she had it before the vaccine, maybe it was after, she cannot remember. Investigations: not but if she does not feel better she is going to see her primary care because she does not know when she sees them, but she gave her something. Treatment: caller states she did see her doctor on 15Apr2021, and she gave her benzonatate 100 mg because she was coughing and it hurt her ribs and she was complaining and can still hear it in her voice. She had a few pills left. Caller adds she was also given a steroid to help her get better. It was not like a flu or stomach bug and the doctor did not think, and they did not know if it was something she ate because they did not have a sample of the food and she did not eat out. The doctor gave her low dose of steroids, she did not want to give her a high dose. It was 7 days after, she said it was okay, 4 mg dose of, what is the name - not a z-pack, a medrol pack. She thinks that is how i is spelled. Medrol pack Prednisone. 4 mg tablets and she does 5, 4, 3, 2, and 1. Caller asks if that dose sounds right. The adverse event, there was no need to visit the emergency room. Also, there was no need to visit the physician office. Prior to vaccination, within 4 weeks the patient had not taken any other vaccines. she told the lady that she had low IgG, so she updated them and they did not say anything was different. They said she could still get the shot and everything. They asked about the Botox and then said as long as it was over a week ago, or seven days ago. The patient underwent lab tests and procedures which included blood immunoglobulin g decreased: low on an unspecified date in 2021. Therapeutic measures were taken as a result of headache and coughing. The outcome of all the events was unknown. No follow-up attempts are needed. No further information is expected.
54 2021-06-01 numbness, pain in extremity, tingling Vision in right eye became very very blurry, not matter what I did. woke up the next day not being ... Read more
Vision in right eye became very very blurry, not matter what I did. woke up the next day not being able to see anything in that eye, except blurry lights. The day I received the vaccine my feet developed pins needles and numbness with pain and it comes and goes. It spreads to my hands and arms. I have been very itchy as well, covered in hives.
54 2021-06-01 pain in extremity, weakness left inner arm pain and weakness continuing sine 1 week after injection
54 2021-06-01 pain in extremity Tender and sore muscles at the back of both thighs and calves; Tender and sore muscles at the back o... Read more
Tender and sore muscles at the back of both thighs and calves; Tender and sore muscles at the back of both thighs and calves; Also cannot hike without severe pain after; This is a spontaneous report from a contactable consumer or other non hcp. A 54-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 01Apr2021 13:00 (age at vaccination 54 years) as single dose for COVID-19 immunisation at hospital. The patient medical history was not reported. Concomitant medication includes Steroid pills. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient experienced tender and sore muscles at the back of both thighs and calves so much so that she could no longer squat without pain or get back up from that position, also cannot hike without severe pain after, on 06Apr2021. No treatment received. The outcome of all event not recovered. No follow-up attempts are needed. No further information is expected.
54 2021-06-01 tingling Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness ... Read more
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: got light headed and felt a tingling in her head then vision went black -Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: 4 days after 2nd dose patient felt lightheaded, tingling in her head, then everything went black for a moment. she still feels light- headed
54 2021-06-02 flushing, hot flush pt says that she has episodes of hot flashes that last about 10 minutes and they come and go during ... Read more
pt says that she has episodes of hot flashes that last about 10 minutes and they come and go during the night and were intense. These episodes come about every hour or hour and half. She says her face would flush and her skin is hot to the touch. Especially her face, head and neck. Pt states the symptoms seem to be getter better.
54 2021-06-02 pain in extremity, weakness After vaccination I still had output out of my Ilestomy bag (diarrhea). By Friday evening I began om... Read more
After vaccination I still had output out of my Ilestomy bag (diarrhea). By Friday evening I began omitting with extreme nausea, incredible chills mixed with incredible sweats (where I saturated the bed and wanted to die). I was too weak to get out of bed and go to the ER in the City. So I emailed my GI clinic to tell her what happened on Mon March 5th and was told to go to the ER for evaluation. I went to the ER on the 6th. I asked her if she could schedule a CTE to see if the Chron's was flaring / if I had a blockage. I continued to drink clear broths. Then I had sips of a smoothie and it triggered the nausea vomiting's, extreme pain of #25 but without chill/night sweats. I went to the ER on the 6th, they did a CT which showed I had an acute Chron's flair going up a foot of my Ilestomy bag and inflamed causing the bowel obstruction and was discharged to follow-up with my GI. my leg continued to hurt and when they did the contrast test in the ER my leg turned dark and all veins were really dark. On the 9th I saw Dr and told him about the leg pain and what was going on and he told me to follow up with my GI. I tried to get a port in my chest because of the continued diarrhea. On the 13th in the morning I was called to go to the Hospital and went the same day, the nurse was preparing me for all the tests to be done the 14th. I asked the Nurse to look at my leg and she did and then left and got other clinicians and they confirmed I had multiple blood clots. They treated me with high dose Heparin for the blood clots. I couldn?t because I was in so much pain. I was in the hospital for 8 days and left the 20th of April. I had falls in the hospital. I continue to have difficulty eating and losing a lot of weight. And now getting the Entivio infusions every 4 weeks.
54 2021-06-02 pain in extremity Wife received her first doe of the Pfizer COVID-19 vaccine on 5Apr2021 and received second dose on 2... Read more
Wife received her first doe of the Pfizer COVID-19 vaccine on 5Apr2021 and received second dose on 22Apr2021; Wife received her first doe of the Pfizer COVID-19 vaccine on 05Apr2021 and received second dose on 22Apr2021; Right Arm Pain especially at elbow joint; Right Arm Pain especially at elbow joint; Having too much pain in muscle; cannot move joint, having difficulty moving right hand; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: Unknown and expiry date was not provided), via an unspecified route of administration, in the right arm, on 22Apr2021 at 16:00 (at the age of 54-years-old) as a single dose for covid-19 immunisation. Patient's medical history included anxiety and depression. Concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient had a flu vaccine 3-4 months before and did fine. No adverse events following prior vaccinations. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: Unknown and expiry date was not provided), via an unspecified route of administration in right arm on 05Apr2021 as a single dose for covid-19 immunisation. The patient did not have any other products. On 26Apr2021 (after 4 days of vaccination), patient experienced right arm pain especially at elbow joint, having too much pain in muscle and cannot move joint, having difficulty moving right hand. Treatment received was wrapping arms using (paracetamol) TYLENOL, pain killer rubbing gel, hot water, rubbing with soft cloth, ice, massage and was not getting relief. Reporter seriousness for right arm pain especially at elbow joint and difficulty moving her right hand was unspecified. The events do not result in emergency room/ physician office. Outcome for event right arm pain especially at elbow joint and cannot move joint, having difficulty moving right hand was not resolved and for having too much pain in muscle was unknown. Follow up attempts are needed. Further information is requested.
54 2021-06-02 pain in extremity Left arm pain and weakness, left side neck pain and stiffness occurred right away and haven?t gone a... Read more
Left arm pain and weakness, left side neck pain and stiffness occurred right away and haven?t gone away
54 2021-06-02 pain in extremity Fever (unable to measure due to lack of thermometer while traveling and in hotel) Chills Severe body... Read more
Fever (unable to measure due to lack of thermometer while traveling and in hotel) Chills Severe bodyaches Fatigue L Arm injection site tenderness and L Upper Arm Pain Sluggish in movement Dehydration
54 2021-06-02 seizure, pain in extremity The first vaccination dose when we went to the car we sat in the car for 15-30min. After about an ho... Read more
The first vaccination dose when we went to the car we sat in the car for 15-30min. After about an hour I started to have Paraoxysmaldyskinesia and seizures (they are secondary condition to the MS). And I began to have this in the car. I started to have paralyze in both legs but my left leg began to hurt. And I began to have terrible diarrhea and I have Chron's disease and I have a Ileospomy bag (and I've had this since March of 2017). A week later after vaccination I had an infusion of Entyvio (biologic) which is regularly scheduled and happened to be a week after the shot. It helped the diarrhea. I contacted my GI doctor to ask if they could move up my infusion to so it could be after my next dose. They said all their patients are seeing diarrhea after vaccination and no they couldn't move it up. I continued to have pain in my legs, fatigue even after going up stairs, difficulty walking. In 2014 I had Sciatic in that leg and a blood clot so I thought it was due to that and never assumed it was a blood clot. And the pain was getting worse each day but I assumed it was all related to the Chron's and not a blood clot.
54 2021-06-03 numbness, pain in extremity She had sever swelling on her left arm the size of a baseball, bruised, numb and painful. Treated it... Read more
She had sever swelling on her left arm the size of a baseball, bruised, numb and painful. Treated it with ice, no pressure on arm. Took two days to go down.
54 2021-06-03 migraine, weakness migraine headache; weakness; I woke up the next morning approximately 6 AM violently vomiting; This ... Read more
migraine headache; weakness; I woke up the next morning approximately 6 AM violently vomiting; This is a spontaneous report from a contactable Other Health Professional (Patient). A 54-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 18:00 as 1st dose, single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, Hashimoto's thyroiditis, sjogren's syndrome from 1992 to an unknown date, chronic back pain, previous posterior anterior surgery with placement of Harrington rods 1992. known allergies: Sulpha drugs. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN); aripiprazole; fluoxetine and trazodone. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. Patient was not pregnant at the time of vaccination. It was reported that patient woke up the next morning approximately 6 AM violently vomiting, migraine headache and weakness on 05Mar2021. Patient did not receive any treatment for events. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
54 2021-06-03 pain in extremity Fatigue; Her "stomach feels like there's a knife",; She feels like she's "about to die", "I feel awf... Read more
Fatigue; Her "stomach feels like there's a knife",; She feels like she's "about to die", "I feel awful".; Wasn't feeling well; She "can't stand up straight", she's not been out of the house since Tuesday; Not eating; Vomiting; has Arm pain; Can't get up hardly; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (at the age of 54-year-old) (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on an unspecified date for covid-19 immunisation and she was sick pretty bad too. The patient reported that she received the second dose of the vaccine on Tuesday and she felt like she was "about to die" and felt awful in 2021. She was not transferred to Safety since she wasn't feeling well. She stated since the second dose, she cannot stand up straight, she had not been out of the house since Tuesday, she was not eating, was vomiting, fatigue, her stomach felt like there was a knife, has arm pain, and she can't get up hardly. She was referred to her healthcare provider. Outcome of events was unknown. Information about lot/batch number has been requested.
54 2021-06-03 tingling, pain in extremity Arm tingle a few minutes after 2nd vaccine; Next day sore arm; 100.8 fever/ Fever lasted 12 hours; T... Read more
Arm tingle a few minutes after 2nd vaccine; Next day sore arm; 100.8 fever/ Fever lasted 12 hours; Then itchy and swollen arm end of day 3; Then itchy and swollen arm end of day 3; This is a spontaneous report from a non-contactable consumer (patient). A 54-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided), via an unspecified route of administration in left arm on 03Mar2021 at 15:30 (at the age of 54-years-old) as a single dose for covid-19 immunisation. Patient had known allergy to neomycin. Medical history included chronic venous insufficiency (CVI) and lymphedema. Concomitant medication included apixaban (ELIQUIS) and acetylsalicylic acid (ASPIRIN). Patient did not receive other vaccine in four weeks of vaccination. Other medication in two weeks included apixaban (ELIQUIS) and acetylsalicylic acid (ASPIRIN). Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Patient had previously received first dose of vaccine in left arm on 09Feb2021. On 04Mar2021 at 12:00, arm tingle a few minutes after 2nd vaccine. Next day sore arm and 100.8 fever lasted 12 hours. Then itchy and swollen arm end of day 3. Need a Benadryl. No treatment was received. The outcome of all events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
54 2021-06-05 pain in extremity About 45 minutes after l received my vaccine, my eyes started to water and nose was runny ( most of ... Read more
About 45 minutes after l received my vaccine, my eyes started to water and nose was runny ( most of the entire day! No allergies before this! About 4 hours after vaccine l had a drink of water had was chocking on a sip( couldn?t breathe ( spitting and sweating) couldn?t catch my breath! Very scary. Shortly a few minutes later ( tried to suck on a piece of melted chocolate and could pass throat. Another chocking event occurred. I find by gagging and spitting to get relief and breathe. Heavy feeling in my chest lasted until evening ! Still very sore arm today
54 2021-06-06 muscle spasms Severe and excruciating cramping in my left leg that I have thrombosis in. The last time I had this... Read more
Severe and excruciating cramping in my left leg that I have thrombosis in. The last time I had this is when a clot developed again and hematologist then put me in warfarin(was in Xeralto previously)
54 2021-06-06 pain in extremity, muscle spasms Ten days after my second COVID vaccine, I woke up one morning and could barely walk. My feet were v... Read more
Ten days after my second COVID vaccine, I woke up one morning and could barely walk. My feet were very painful. My calves, ankles, forearms, wrists and base of my skull were experiencing "charlie horse" like sensations. Prior to this occurrence, nine days after my first COVID vaccine, I experienced what appeared to be an infection in my right index finger, no explanation how it happened. There was no incident leading up to it. My finger bled on the top side for no known reason and then a discolored painful bump appeared near the fingertip (on the palm side of my hand). I could not bend my finger. It was extremely swollen and painful. I visited the doctor about this on 1/15/21 and was prescribed a 10 day anti-biotic. I completed the regimen. The swelling and pain went away. The discolored raised bump did not. The spot which bled healed with no problem. This report is difficult to navigate. To make sure the dates of my COVID vaccines are clear and the onsets of my symptoms--- 1st Pfizer shot was given on Tuesday, January 5, 2021 in my right arm. The onset of first symptoms occurred on Thursday afternoon, January 14. I visited the doctor for this the following day (January 15). 2nd Pfizer shot was given on Tuesday, January 26, 2021 in my left arm. The onset of symptoms as described below began early morning 10 days after the second shot was administered. I woke up with these symptoms (as described below).
54 2021-06-07 flushing, tingling pt had appt for Covid-19 vaccine 1st dose. Upon receiving vaccine, within 5-7 minutes patient was ... Read more
pt had appt for Covid-19 vaccine 1st dose. Upon receiving vaccine, within 5-7 minutes patient was hyperventilation, complaining of Nausea, "tingling of Limbs", appeared flushed. 911 was called and she went home, refused Emergency visit.
54 2021-06-07 feeling of insects crawling on skin, numbness I waited the extra time to make sure I was fine. 40 min after I was driving, I felt like something w... Read more
I waited the extra time to make sure I was fine. 40 min after I was driving, I felt like something was moving under my skin; it went to the neck and up my face. Left head of my head was numb. From right side of my face, both arms, were numbed. I went home. On February 5 went to see the doctor but he did not see anything, so he only gave me B supplements and told me to relax and to get back to him if I did not feel better.
54 2021-06-07 pain in extremity Minor issues in the first 24 hours were unexpected and early onset of menstrual cycle next morning, ... Read more
Minor issues in the first 24 hours were unexpected and early onset of menstrual cycle next morning, and altered taste sensations that lasted one day. Minor arm pain. No actions were taken. On April 22, vertigo began gradually and was intense by the morning of April 23. This included the sensation of intense spinning. The vertigo continued intensely for about three weeks and then tapered off until June 1, when there was no more sensation of spinning. Bonine and the Flonase provided adequate relief during this period.
54 2021-06-07 pain in extremity Bright red rash starting at the wrists and extending up to forearm; Red rash was tender almost like ... Read more
Bright red rash starting at the wrists and extending up to forearm; Red rash was tender almost like a sunburn; Red rash was tender almost like a sunburn; Itching throat; Slight wheezing; Mucous causing cough; Mucous causing cough; Feeling of anxiousness; Arm was also sore enough that it hurt to lay on it; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER COVID-19 vaccine, Lot Number: GN6198), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 15:45 (at the age of 54 years old) as single dose for covid-19 immunization. Medical history included body mass index (BMI) more than 30, known allergies included: penicillin, latex sensitive, allergic to propylene glycol. The patient did not have COVID prior vaccination. The patient did not have any other vaccine in four weeks and did not pregnant at time of vaccination. Concomitant medication in two weeks included Vitamins. On 04Mar2021 at 01:00 AM, the patient Woke up from sleep with itching throat, slight wheezing, and mucous causing cough. It caused her to have a feeling of anxiousness because it happened so suddenly. After about 1 hour, it stopped just as suddenly as it all started. Arm was also sore enough that it hurt to lay on it. No swelling at injection site. This lasted for about 1 hour. On 09Mar21 noticed a bright red rash starting at the wrists and extending up to forearm. The red rash was tender almost like a sunburn. The patient had not been tested for COVID-19 post vaccination. No treatment for AEs. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
54 2021-06-07 pain in extremity Patient came in for her second dose of the Covid-19 immunization. She stated that the arm had hurt s... Read more
Patient came in for her second dose of the Covid-19 immunization. She stated that the arm had hurt since her last shot, was swollen and she thought had a foreign body left inside the arm. She believed the needle had broken off in the arm. I reviewed her paperwork from the previous shot and no notes were made regarding the integrity of the vaccine administration. I examined her arm by touching and feeling the area of the vaccine but could not feel anything inside the arm. She was referred to the ER for evaluation, In the ER they performed an Xray but did not find anything inside the arm. She was diagnosed with cellulitis and was prescribed antibiotics.
54 2021-06-07 trigeminal neuralgia, nerve pain 4/1/21 Started with nerve pain around my neck and back. On 4/4/21 symptom of trigeminal neuralgia, ... Read more
4/1/21 Started with nerve pain around my neck and back. On 4/4/21 symptom of trigeminal neuralgia, felt as if I were having a stroke and went directly to the ED. Stroke was ruled out and a small rash appeared on my shoulder blade. ED suspected shingles as a reaction to the Covid Pfizer Vaccine. On 4/7/21 rash appeared on upper back, neck and front shoulder. Pain became very severe. Started on acyclovor. Rash and pain became worse, back to the ED on 4/20/21, was direct admit into the hospital until 4/24/21.
54 2021-06-08 difficulty speaking, pain in extremity approximately two weeks after my first injection I came down with a terrible cold and then swelling ... Read more
approximately two weeks after my first injection I came down with a terrible cold and then swelling and pain in my right foot. I also started noticing less sensitivity in my hands, cold feet and weakness in my hands. After I received my second shot, the pain in my feet worsened, I had extreme pain in my lower back. My chest congestion continues and my voice is raspy.
54 2021-06-08 migraine Inflammation of joints substantially worse, migraine, hallucinations
54 2021-06-09 pain in extremity Pain in the right arm; affected the rotator cuff; taste and smell were affected; my taste and smell ... Read more
Pain in the right arm; affected the rotator cuff; taste and smell were affected; my taste and smell were affected; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 54-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/Lot number was not reported) administered in Arm Right in Feb2021 as 2nd single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 in Jan2021 (at the age of 54years) for Covid-19 immunization. Medical history included lupus, fatty liver disease (genetic, not caused by any other issues), asthma, heart disorder, rheumatoid arthritis, various food allergy, latex allergy, and allergic to Sulfa drugs; all from an unknown date and unknown if ongoing. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA) for an unspecified indication and salbutamol (ALBUTEROL) for asthma; start and stop date of both were not reported. The patient previously took Phenergan and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Feb2021, the patient experienced pain in the right arm following the 2nd dose that never went away, and instead got a lot worse. It has affected her rotator cuff and required a cortisone injection. In 6 weeks, if that has not worked, further testing will be done beyond the X-ray on an unspecified date. Also, following the 2nd dose, her taste and smell were affected, and she has not been able to handle the taste of coffee. She added that she has Lupus and genetic fatty liver disease. The hepatologist had her drinking coffee for that reason. The only thing off on her blood work related to not being able to drink the coffee (as reported). The patient also mentioned that she was having difficulty working at this point in time, because she works at a computer and it's affecting the arm she uses for the mouse. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The events were treated with cortisone injection and X-ray. She also has tested negative to Covid 19, and negative to the antibodies in Mar2021. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Assuming a plausible drug-event temporal association, the company cannot completely exclude a causal relationship between BNT162b2 administration and the onset of the reported, serious events. The event 'pain in extremity' is also expected in the safety profile of the suspect product. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-06-09 tingling Swelling pain Redness and sensation
54 2021-06-09 cold extremities, tremor Fever over 105 degrees, extreme shaking, hands and feet freezing for hours, hyper sensitive skin wit... Read more
Fever over 105 degrees, extreme shaking, hands and feet freezing for hours, hyper sensitive skin with pain everywhere. Took ibuprofen and acetaminophen to help with fever. It did very little to help with it. 24 hours later, and I'm feeling better, although still feel like crud.
54 2021-06-10 inability to speak I received my first covid vaccine on 6/9/21 around 3:35 pm and around 30 minutes after shot, I sta... Read more
I received my first covid vaccine on 6/9/21 around 3:35 pm and around 30 minutes after shot, I started itching a little and noticed a rash on both forearms between wrists and elbows and both shoulders had a small rash. But the rash on my forearms were red and raised. I felt like I was getting the hives with feeling itchy and light headed so my son drove us home as I was having a hard time focusing. When I got home, I took a antihistamine and a Tylenol. A few minutes later I started feeling relief and by a couple hours later the rash was gone. I did feel my chest tighten while I was itchy but I wasn't sure if it was because I was worried/anxious. This morning (next day) everything seems normal, no symptoms.
54 2021-06-10 numbness Dizziness and numbness in one arm
54 2021-06-10 numbness Numbness in the face, still present one week from 2nd dose of Pfizer vaccine.
54 2021-06-10 pain in extremity, nerve pain, numbness and pain in extremities Initially I had pain in my arm at the site of shot. About 2 days after, I had chills and I was tired... Read more
Initially I had pain in my arm at the site of shot. About 2 days after, I had chills and I was tired. About two and a half weeks later, I received light pain in my arm. I took Zorvolex 35mg medication. I woke up with severe pain in my lower arm. Whenever I bend or lean, the pain would intensify. Early in the morning I could barely get ready. I had to do everything with my right arm. I went to Dr that afternoon. I was given Prednisone medication for nerve pain, Tizanidine medication for muscle relaxant. I have been going to different doctors because the pain hasn't gone away and it still hasn't despite multiple medications that I have been on since then. I experienced a sharp pain when the shot was administered. I am limited to what I can do. I have to prevent myself from using my left arm. Through out the day the pain intensifies. No clear improvements.
54 2021-06-10 pain in extremity Soreness in my arm and neck. developed a headache and had fatigue. Got chills, achy, and nauseous. R... Read more
Soreness in my arm and neck. developed a headache and had fatigue. Got chills, achy, and nauseous. Really bad muscle pain. Took Tylenol and Gatorade. Woke up to body aches that were so bad I couldn't move
54 2021-06-13 facial paralysis, numbness The left side of my face went numb. The left side of my mouth was droopy from the numbness and I bec... Read more
The left side of my face went numb. The left side of my mouth was droopy from the numbness and I became hard to swallow.
54 2021-06-14 weakness Received Covid 19 injection in afternoon at medical clinic on right shoulder. The same evening I cou... Read more
Received Covid 19 injection in afternoon at medical clinic on right shoulder. The same evening I could hardly lift my arm above my head. Soreness ensued which was debilitating however it finally subsided and became tolerable. As of this date I am still having shoulder pain. Also?about 10 days after my first c-19 shot I came down with hives. I had hives come and go for over two weeks but became symptom free prior to my next injection.
54 2021-06-15 tingling, numbness Systemic: Allergic: Rash (specify: facial area, extremities)-Mild, Systemic: Heart Attack-Medium, Sy... Read more
Systemic: Allergic: Rash (specify: facial area, extremities)-Mild, Systemic: Heart Attack-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extremities)-Medium, Additional Details: Within 2 mins patent started to feel numbness like novocaine & tingling in left ear. left side of face & left side of mouth, ear and facial area were red & warm.
54 2021-06-16 pain in extremity, electric shock sensation feeling of electrical current going through both hands; slight light-headedness; arm soreness; her c... Read more
feeling of electrical current going through both hands; slight light-headedness; arm soreness; her cholesterol was a little elevated; This is a spontaneous report received from a contactable female consumer. A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955; Expiration Date: 20Jun2021), via an unspecified route of administration, in Arm Left on 21Mar2021 12:30 as 1ST DOSE, SINGLE DOSE, and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0153; Expiration Date: 20Jul2021) via an unspecified route of administration, in Arm Left on 11Apr2021 12:30 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included patient had a lipid panel and recently her cholesterol was a little elevated and had gone down. The following day of both vaccines the patient experienced a feeling of electrical current going through both hands when using devices such as her cellphone 2 to 3 days after Covid 19 vaccine. The feeling has become mild at this time. Patient had been double vaccinated. She thought the second shot was back on 11Apr2021 or something, it has been a while. She had a very strange thing going on. She had not heard anyone else talking about this as a side effect. Did not know if it was unrelated or coincidental that it started when she got the vaccine. Patient inquired if anyone has reported anything about side effects while holding electronics. When holding an iPhone or computer touch pad, she feels almost like an electrical current going through her hands. It was a very strange feeling. She was not a conspiracy theorist at all. When this first started, she called Apple because she thought it was a problem with the phone, like something was emitting something or something was wrong with it. They checked her phone, and everything was fine. She had been to a hand surgeon, hand doctor who thought it may be carpal tunnel. It started right after the vaccine, about a week and a half after she got it. When she holds her phone or computer, on the track pad, it felt almost like an electrical current, like when you get shocked, but just like a mild thing, coming through her fingers into her hand. It was a very strange uncomfortable feeling. About a week and a half after the first vaccine it got so bad, she could not even hold her phone for like two days. She had to carry around holding her shirt out and dropping it into her pocket to hold it walking from room to room. It had been hovering at a low level where she could hold the phone in her hand, but for a couple of days, she could not even hold it. About five days after her second vaccine the same thing happened again, where it was about two days worth of not being able to hold her phone and then it went back to just this very low level and now it had just been staying there ever since then, so it has been weeks and weeks. She was just trying to figure it out. Someone suggested she just call Pfizer and see if anyone else reported anything like this before. The hand doctor treated it as though it was carpal tunnel and gave her a cortisone shot but that did not seem do anything. He thought he would send her to a neurologist, but she thought she would call Pfizer first. Monday, that she finally decided to call Apple. She did not know exactly what day it started, if it was a day or two days afterward but it had been going on about a week when she decided to call Apple. Her husband was holding her phone and he could not feel anything so she held his phone and she could feel it on his phone too and it was really weird. She could even feel it when she put the phone down. Feels it a little bit right now, it did not go away right away. Its kind of has been up and down a little bit. Right now, it was kind of settled. For several weeks it has settled at the same level. It was fine, she could hold the phone, it was just not that comfortable. She had to switch hands, the longer she was holding it, the more it bothers her, and she needs to switch hands. About 10 days after the first shot, it got so bad she could not hold her phone for like 2 or 3 days. Lets see what happens after the second shot. At that point, she had already been to the hand surgeon and he said the same thing, let just see. He thought it might be carpal tunnel and it might have just been brewing under the surface. It could almost be like another side effect that could have brought out the carpal tunnel. The only other side effects from the vaccine were arm soreness It was afterward, and was very brief, until the next day. It was subsiding when she got up in the morning, then went away. and slight light-headedness for 15 minutes. It was a brief time after, maybe an hour. Occurred after both the first and second dose. The doctor gave her the cortisone shot in one hand, so she could compare. She still has it in both hands and has been about 2 weeks since she had the Cortisone shot. She has a follow up appointment with him this afternoon so well see what he says. She just wanted to report this to Pfizer first before she saw him to see if Pfizer had any information. She stated she hopes she is not going crazy but it is a weird thing. Anyway, it was about 10 days after the first shot, it was so bad, she couldn't handle the phone and then 5 days after the second shot. Each time, it lasted 2 or 3 days and then was back to the way it was again. It only got really bad twice, after a shot, then after another shot. It could all be coincidental and something else is going on with her but she wanted to see if anyone else had reported anything like this. Took some Tylenol after the first shot, after the second, didnt take anything for other events. The outcome of the events was unknown. Follow-up(09Jun2021): This is a spontaneous report received from a contactable female consumer. New events were added. Follow-up attempts are needed. Further information is expected.
54 2021-06-16 tingling having tingling to her in face 2 days after receiving the first dose and is ongoing; This is a spont... Read more
having tingling to her in face 2 days after receiving the first dose and is ongoing; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 25May2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 27May2021, she began having tingling to her in face 2 days after receiving the first dose and was ongoing. The patient was scheduled to have the second dose on 15Jun2021 and wanted to know if she should take the second dose of the vaccine. The response included that as the prescribing information did not include all adverse reactions that have been reported or that may occur, please consulted with your doctor/healthcare provider about what you have experienced/were experiencing and because your doctor/healthcare provider was most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider was in the best position to advise you about the appropriate action to take. Outcome of the event was not recovered. Information on the lot/batch number has been requested.
54 2021-06-17 difficulty speaking I have had GI problems, lots of diareahha with eating just about anything. I had a headache, bronchi... Read more
I have had GI problems, lots of diareahha with eating just about anything. I had a headache, bronchitis and raspy voice. Took antibiotics for the bronchitis but it only cleared of the bronchitis. I still have all the other symptoms.
54 2021-06-17 facial paralysis, bell's palsy Bell's palsy over one month later. Right side facial paralysis.; Bell's palsy over one month later. ... Read more
Bell's palsy over one month later. Right side facial paralysis.; Bell's palsy over one month later. Right side facial paralysis.; This is a spontaneous report from a contactable consumer. A 55-years-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in right arm on 08Apr2021 at 11:00 (at the age 54-years-old) as 2nd single dose for COVID-19 immunization. Patient's medical history included hypothyroidism and patient had known allergies gluten, bee or wasp venom. Patient took 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6207) administered in right arm on 11Mar2021; administration time at 11:00 AM. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient's concomitant medications were not reported. The patient experienced bell's palsy over one month later and right side facial paralysis on 25May2021 at 12:00. The treatment medications include prednisone and Valtrex. The outcome of the event was not resolved. Follow-up attempts are needed. Further information is expected.
54 2021-06-17 pain in extremity, seizure, difficulty speaking eyes were so swollen, they were almost swollen shut; voice is really rough and raspy; throat swollen... Read more
eyes were so swollen, they were almost swollen shut; voice is really rough and raspy; throat swollen; headache; blood pressure was high; had a panic attack/anxiety; Low blood sugar; It was like it made her seizure medicines stop working like it halted the seizure medicines; non-stop seizures; It was like it made her seizure medicines stop working like it halted the seizure medicines; Allergic to the vaccination; made her nose run; made her cough like she was in the middle of a grass field; couldn't think straight; not in her right mind before she had her seizures, it affected her brain; has sore calves; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 01Jun2021 (Lot Number: EN0178) at the age of 54-year-old as single dose for covid-19 immunisation(reported as wanted to be able to hold her grandbaby). Time of the vaccination was given at 20:15 - 20:30. Co-suspect drugs included clonazepam, orally taken for seizure at 2.5 mg a day, takes it 5 times a day, they break it up, anxiety from an unspecified start date and ongoing; lamotrigine (LAMICTAL) taken for seizure from an unspecified start date and ongoing at 600 mg a day, 6 pills a day; gabapentin (NEURONTIN) taken for seizure from an unspecified start date and ongoing at 600 mg a day per day. There were no vaccines administered on same date with the Pfizer vaccine considered as suspect. Prior vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as none. Medical history included seizures, ongoing anxiety, brain tumor (discovered when she was 21 years old), brain surgery in 1994 (brain surgery was on the left side, her surgery was done when she was 27 years old, she had been pregnant), blood pressure usually low, really low, allergic to blue dye, allergic to a lot of antibiotics, ongoing thyroid being gone, allergic to grass. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid being gone from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC) taken for allergy from an unspecified start date and ongoing. The patient previously took lorazepam for seizure. The patient experienced non-stop seizures on 01Jun2021 with outcome of recovered on 01Jun2021, headache on 01Jun2021 20:45 with outcome of recovered on 02Jun2021, blood pressure was high on 01Jun2021 with outcome of unknown, eyes were so swollen, they were almost swollen shut on 02Jun2021 with outcome of not recovered, voice is really rough and raspy on 02Jun2021 with outcome of recovering, throat swollen on 02Jun2021 with outcome of not recovered, made her nose run on Jun2021 with outcome of unknown, made her cough like she was in the middle of a grass field on Jun2021 with outcome of unknown, couldn't think straight on Jun2021 with outcome of unknown, not in her right mind before she had her seizures, it affected her brain on Jun2021 with outcome of unknown, has sore calves on Jun2021 with outcome of unknown, had a panic attack on 01Jun2021 with outcome of recovering, allergic to the vaccination on Jun2021 with outcome of unknown, low blood sugar on 01Jun2021 with outcome of unknown, "It was like it made her seizure medicines stop working like it halted the seizure medicines" on 01Jun2021 with outcome of recovered on 01Jun2021. The patient was calling to report this vaccination, which had caused her a lot of trouble. She had an ambulance come within the hour after receiving it. The police department, ambulance and the EMT they charged for that and then she had non-stop seizures they wouldn't stop and she took medication and they finally did stop. She did have seizures, they found out she had low blood sugar, but that's from a brain tumour and brain surgery she had. She had to be careful of her sugar content, she's not diabetic, she's opposite of diabetic. Her blood sugar was 92. Her blood pressure was high, it's usually low, really low. It was 138/72 or something and it's usually 92/56. She's not heavy, she's light, about 110 pounds. She's healthy, well in a healthy condition. She didn't have a thyroid, but she took medication. She guessed she's not the healthiest person. She finally made it to bed last night and she was up this morning and her eyes were so swollen they were almost swollen closed. She was putting tea bags under eyes. They were so swollen one of them was almost swollen shut and now she could hear her voice was really rough and raspy. She was pretty positive she's allergic to the vaccination. She didn't know what to do. She could not hold her grandbaby unless she had the vaccination that's the only reason she got one and now she's stuck and her eyes look terrible. She thought people with seizures with epilepsy she thought there should be a warning that it could cause seizures and to double up on medication. She was allergic to blue dye, that would do the same to her she didn't know if it had blue dye in it but she's allergic to that. She's also allergic to a lot of antibiotics. She got the vaccination late at (facility name withheld) about 20:15 last night on 01Jun2021 and within half an hour these symptoms started 20:45-21:00. Her throat was swollen. She didn't normally sound raspy, she sounded normal and had a little nicer voice usually. She still had the headache with seizures. The seizure ended because of the medication, she still wouldn't have ended her seizures if she hadn't take the medication, they would have ended later. The seizures were gone because she's on her medicine. Now it was her eye and her voice. The headache started within a half hour its a precursor an aura to the seizure. It started at 20:45. It was like it made her seizure medicines stop working like it halted the seizure medicines. She couldn't think straight she called people and talked to people. She was not in her right mind before she had the seizures it was weird. It affected her brain. She also had sore claves. Her calves were very strong and muscled she worked out a lot. She had anxiety but its better since her divorce and one of the pills for the seizures was an anxiety pill too it did both they figured out. What happened after she got the shot was she got anxiety, she thought what the heck. She had a panic attack, she thought that was so weird that was on the road. When she got home she was okay. Her voice was feeling better this was her talking normally, it's getting better. Also this shot made her nose run and made her cough like she was in the middle of a grass field, which she's allergic to grass. She just felt like that was weird. She's just allergic to that blue dye and allergic to a lot of medicine. Events did not resulted in emergency room or physician office visit. Patient declined to go to emergency room when asked by ambulance. The ambulance offered to take her she said no thank you. Treatment received included lorazepam: she took something called lorazepam to stop the seizures. That's the drug they gave her at the hospital and she had some for non-stop seizures which she's had in the past she's had these pills just in case because she lived alone. She put it by her bed just in case she had to take it again. The Lorazepam was 0.5 mg tablets she took one. She only took it if it's a non-stop seizure. She's taken it 3 times maybe in the last 3.5 years. The action taken in response to the events for clonazepam, lamotrigine and gabapentin was unknown.
54 2021-06-18 weakness Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Vaginal bleeding for 2 ... Read more
Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Vaginal bleeding for 2 days, patient has not had period for 7 years prior-Medium, Systemic: Joint Pain-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Being checked for anemia post bleeding
54 2021-06-18 hot flush low grade-fever day after on 13th, low-grade fever again on 17th, soreness at injection site, wide ... Read more
low grade-fever day after on 13th, low-grade fever again on 17th, soreness at injection site, wide spread joint pain, severe low back pain, chronic join pain, chronic low back pain, chronic knee pain, chronic tiredness, chronic malaise, chronic lethargy, hot flashes, higher blood sugar readings, weight loss, hair loss, chronic fatigue, stopped having menstrual cycles, chronic pelvic pain
54 2021-06-18 numbness numbness of face , increase in heart rate
54 2021-06-21 hot flush I started experiencing hot flashes the day after the 1st dose and they continued 5-8 times daily un... Read more
I started experiencing hot flashes the day after the 1st dose and they continued 5-8 times daily until the second dose of the vaccine, in which they disappeared altogether.
54 2021-06-21 muscle twitching, electric shock sensation myoclonus- muscle twitching in the entire arm that was vaccinated. patient states it feels electrica... Read more
myoclonus- muscle twitching in the entire arm that was vaccinated. patient states it feels electrical as muscles twitch at rest and was arm is being used
54 2021-06-21 tingling, weakness, numbness 6/8 Patient presented in the Ed with weakness, tingling and numbness in the hands and lower extremit... Read more
6/8 Patient presented in the Ed with weakness, tingling and numbness in the hands and lower extremity. She reports symptoms for the previous 3 days. LP remarkable for elevated proteins (80) with 0 WBC and RBC. Recent questionable URI and a few episodes of diarrhea were reported. Pt had "stocking-glove paresthesias suggestive of Guillain-Barre Syndrome and was placed on IVIG therapy. Discharged from the hospital improved on 6/19/2021.
54 2021-06-22 numbness and pain in extremities, inability to speak, slurring, numbness, speech disorder, tingling Dose #1- I had trouble speaking and was slurring with words and having difficulity with words recall... Read more
Dose #1- I had trouble speaking and was slurring with words and having difficulity with words recall. I also had facial numbness. It started on the right side of my forehead and spread to the left eye and down the jaw bone, along the right jawlines and down both arms and hands. It feels like tingling sensation like ?getting a novocaine shot? . The neuropathy has not improved or gone away. No pain, just a numb sensation. This is 24/7 all the time and does not go away. I did go see chiropractor to get evaluated and he did not see anything. He prescribed vitamin B. My speech impairment had resolved as of now, but the neuropathy remains.
54 2021-06-22 pain in extremity, numbness Patient is mainly concerned about left-sided pain. She states that she got the Pfizer COVID vaccine... Read more
Patient is mainly concerned about left-sided pain. She states that she got the Pfizer COVID vaccine 2nd dose on 04/23/2021. Two days later she started developing neck pain with stiffness in the neck shoulder pain and arm and forearm pain with numbness and pain over her left hand. Soon thereafter she also started getting left hip pain and left leg pain going into her knee. This has been present over the last 2 months though she feels that in the last 2 weeks it has relented and improved though it still continues to be present. She has difficulty sleeping on account of this. She denies similar problems prior to the vaccine. She states that she tried to go on to the vaccine adverse event for reporting System website but could not report this and hence tried to ask the clinic as to how she would do it.
54 2021-06-22 speech disorder, inability to speak, slurring Within hours, I noticed speech impairment. I was having trouble recalling words. I was also slurry ... Read more
Within hours, I noticed speech impairment. I was having trouble recalling words. I was also slurry my words (not as pronounced as in the 1st dose). I felt like my brain felt "concussed". It feels like brain fog and it takes extra time to get words out. My short term memory has been affected and I am having difficulty focusing. I am still suffering from brain fog and my short term memory is not as sharp anymore.
54 2021-06-22 tenderness When the shot was given it hurt like any normal Vaccine or shot that I have been given before. But,... Read more
When the shot was given it hurt like any normal Vaccine or shot that I have been given before. But, the next day I woke up and my armpit was swollen and the underneath part of my arm was very tender to the touch. These symptoms lasted a little over a week total. I went back to the clinic on 5/25/21 just due to how long it was staying swollen and tender wanted to make sure that this was something that needed to be documented. Doctor advised me to not take the second dose due to my reaction to the first dose. I had Covid 19 back in October of 2020.
54 2021-06-22 tremor After the vaccine I want to say around 12 hours later I experienced a fever, chills, I was shaking c... Read more
After the vaccine I want to say around 12 hours later I experienced a fever, chills, I was shaking consistently , I had diarrhea for about 3 to 4 days after the vaccine . I had a fever of 102 .The following day the nausea that I started to experience was horrific to the point where I felt like I wanted to vomit but I just could not throw up, and was also experiencing fatigue and constant vaginal infections. I have had two periods and and nonstop bleeding after the second dose. I will be going to get an ultrasound next week in regard to what I experienced with the vaginal bleeding.
54 2021-06-23 burning sensation About two weeks after vaccine, I started to have respiratory symptoms. After two months of suffering... Read more
About two weeks after vaccine, I started to have respiratory symptoms. After two months of suffering from them, I figured out it's more like gastric reflux, GERD. Wheezing, coughing. Lots of mucous and fluid and some burning in my belly. I did a video visit with my respiratory doctor (an independent physician) in May, not sure of date. He did not believe it was respiratory. I recently saw him again on June 21 and he confirmed that it wasn't respiratory. A nutritionist and acupuncture doctor has helped me the most. I did see my primary care doctor today and she confirmed that I'm doing better. The nutritional changes I've made have helped me the most. I am about 85% better.
54 2021-06-24 breast pain Pfizer-BioNTech COVID-10 Vaccine EUA. After receiving her 1st dose of Pfizer vaccine, patient exper... Read more
Pfizer-BioNTech COVID-10 Vaccine EUA. After receiving her 1st dose of Pfizer vaccine, patient experienced an intermittent headache, nausea, fatigue, and a "weird sensation." Her VS included BP 132/92, P 77, O2 99%. Patient stated she in is remission from sarcoid. Certirizine 10mg PO and Famotidine 20mg PO administered at 1304. Patient denied SOB, trouble breathing or swallowing, and symptoms of anaphylaxis. At 1316, patient reported feeling better but had a localized left breast pain rated at a 6/10. Patient felt comfortable with no additional or worsening symptoms upon leaving clinic.
54 2021-06-24 burning sensation, nerve pain, tingling So the first adverse event was shingles, and that was maybe a week or two after the second vaccine, ... Read more
So the first adverse event was shingles, and that was maybe a week or two after the second vaccine, I just don't know because I did not keep track of it all. The second thing was pain in the right shoulder and like terrible nerve pain going up my neck and down underneath my right armpit and also tingling up the right and back of my head - just burning, aching and made it hard to breath at times. I saw the DR at ER on 6/19/2021 and saw a sports medicine DR on 6/22/2021.
54 2021-06-24 feeling of body temperature change, weakness, pain in extremity Joints hurting/joint ache; Her left shoulder received the shot but the right is feeling worse; Feeli... Read more
Joints hurting/joint ache; Her left shoulder received the shot but the right is feeling worse; Feeling warm and cold; Knees are killing her with so much pain; Cold and hot sweats; Chills; She got very lethargic; She was very weak; She was falling asleep, she actually fell asleep for about 20-25 minutes; Body ache; Her fingers and feel like pain; Right is feeling worse as well/it was horrendously worse, like 10 times worse than her normal arthritis pain/her arthritis just worsened; This is a spontaneous report from a Contactable Consumer. A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL3247) via an unspecified route of administration on 04Feb2021 10:00 (at the age of 54-year-old) as single dose for covid-19 immunisation. The patient's medical history included arthritis, (She has arthritis and she took 2 tylenol last night which made her able to sleep). Patient's concomitant medications were not reported. The patient had her 1st dose of the Pfizer Covid vaccine yesterday(04Feb2021) at 10 AM and started experiencing cold and hot sweats, chills, and joints hurting like body aches. The patient also complained that her left shoulder received the shot but the right is feeling worse as well. She is also reporting a body ache, joint ache, feeling warm and cold. She has arthritis and she took 2 tylenol last night which made her able to sleep. but today, all the symptoms came back and her knees are killing her with so much pain. The thing was she took it yesterday and she was fine with in a half hour she stayed, they had her stay 15 minutes and she stayed and stayed a little more because it was through her work, she works at a facility, an assisted living facility. The thing was that she came home and ate some eggs, she ate breakfast and she got very lethargic and was very weak and she was falling asleep, she actually fell asleep for about 20-25 minutes and she woke up and could not get up, she was very weak and had chills and went to get blanket she had some paperwork and it said she could experience this but she then after that she went upstairs and laid down and fell asleep and her joints started hurting like body aches, she has arthritis in her knees, she put on lotion and the thing was it was horrendously worse, like 10 times worse than her normal arthritis pain she was wondering kind of like what was going on was this side effects going on. Then it was hard for her to fall asleep she was kind of uppity and she did not fall asleep until 3 am, she got up she was hurting so bad and it was like the same locations that she usually gets pain from her arthritis just worsened, her fingers and feel like pain. She was wondering how long does it last. She did read the paper and it was part of it and she wanted to see does this last or does it go way or repeat itself. She reported that It started happening probably when she was 39 or 40. She clarifies that is when she first ever had joint arthritis pain. She clarifies the experience with the vaccine happened right now when she is 54. She confirms this was her first COVID 19 vaccine she did not previously received a different manufacturers COVID 19 vaccine. The outcome of the events reported was unknown. Follow-up attempts are completed. No further information is expected.
54 2021-06-24 feeling of insects crawling on skin rash all over the body/ rash on torso; Temperature 103.9/Fever up to 103; felt like her body was bei... Read more
rash all over the body/ rash on torso; Temperature 103.9/Fever up to 103; felt like her body was being attacked inside, stinging all over inside and settled in the joints/pain; felt like an army of ants were crawling and attacking inside; Pain all over but especially in joints; Arm swelled; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 04Mar2021 at 05:30 AM (Batch/Lot number and expiry date were not reported) (at the age of 54-years-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included brain trauma that has resulted in some chronic health issues. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications were not reported. On 04Mar2021, the patient received the first dose and she had an immediate reaction which lasted almost 14 days. She called the County health department and they told her that it was normal to have that reaction that severe for some people and that she can receive her second vaccine and she spoke with her doctor who said that she will not go forward until they figure out what happened. She was told by the County to take Tylenol and go to bed for a while. The patient had a rash all over the body and had a temperature of 103.9. She felt like her body was being attacked inside, stinging all over inside and settled in the joints. She felt better for approximately two weeks, 14 days not great but better. She felt little better and on 24Apr2021, she experienced the exact same reaction that is 10 times worse and it settled in her joints, which has been awful and it was not going away and she changed 4 doctors now and they all said there was nothing that they can do when you have a reaction to the vaccine. Patient was asking if there is something that she can do so that maybe she can get her life and body back and she was very sick and doesn't know what to do. Upon follow up on 09Jun2021, seriousness criteria was reported as disabling /incapacitating. On 04Mar2021 at 05:45, the patient experienced an immediate reaction: the patient's arm swelled, felt like an army of ants were crawling and attacking inside, had fever up to 103 and did not break with Tylenol (directed to take and told this all was normal). The patient also had rash on torso, pain all over but especially in joints. Patient gradually felt better after fourteen days. Then on 04Apr2021 (as reported), she had the very same reaction but so much worse and it has never left, except for no rash. The fever lasted 14 days but is gone. She saw the doctor to assure it wasn't something other than the shot and assured he could not see that it was anything else and it would take a while to dissipate. Patient saw a functional medicine doctor to treat naturally, to no avail. She saw her primary physician who also has no idea how to treat. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events joint pain, stinging, arm swelled and rash all over the body was not recovered, while for fever was recovered on 18Mar2021. Information on the batch/lot number has been requested.
54 2021-06-24 nerve injury, pain in extremity, tingling, numbness Felt a pain in my upper left back shoulder area, shooting pain down my arm and fingers numb/tingle. ... Read more
Felt a pain in my upper left back shoulder area, shooting pain down my arm and fingers numb/tingle. It felt like nerve damage; Felt a pain in my upper left back shoulder area, shooting pain down my arm and fingers numb/tingle. It felt like nerve damage; Felt a pain in my upper left back shoulder area, shooting pain down my arm and fingers numb/tingle. It felt like nerve damage; Felt a pain in my upper left back shoulder area, shooting pain down my arm and fingers numb/tingle. It felt like nerve damage; Felt a pain in my upper left back shoulder area, shooting pain down my arm and fingers numb/tingle. It felt like nerve damage; feeling of pins and needles in her left hand; Shoulder and back pains; Muscle pain that radiates down her arm; Muscle pain that radiates down her arm; This is a spontaneous report received from a contactable consumer (the patient). A 54-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7533), via an unspecified route of administration, in left arm on 14Apr2021 at 09:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease. The patient's concomitant medications included vitamins (unspecified). The patient was not allergic to any medications, food, or other products. No other vaccines in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 14Apr2021 (reported as approximately 30 minutes after), the patient felt a pain in her upper left back shoulder area, shooting pain down her arm and fingers numb/tingle. It felt like nerve damage. On an unspecified date in Apr2021, she had shoulder and back pains, muscle pain that radiates down her arm. She will not be getting the second dose because of these. Clinical course included: the patient reported that she had a pain in back by shoulder by muscle that radiates down her left arm like stinger. She had shoulder and back pains. Stated that her fingers have feeling of pins and needles in left hand (numb). She wanted to find out what can be done to get pain to go away and if this is normal for her to experience. Stated that it brought her to tears. Stated that she has a muscle relaxer and a steroid, that both she has been on for three days and it still hurts on the pill. Later clarified muscle relaxer as methocarbamol (expiry date: 04Aug2022) pills in an orange-coloured bottle and the steroid as prednisone (expiry date: 20Apr2022) pills in an orange-coloured bottle. Stated that she normally uses her glasses to read the labels. It has been 8 days and she was still in pain. The adverse events resulted doctor or other healthcare professional office/clinic visit. The patient received treatment for adverse events with doctor prescribed methocarbamol pills and prednisone pills for pain. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not resolved. No follow-up attempts are needed. No further information is expected.
54 2021-06-24 tingling, numbness, pain in extremity Upon receiving the injection I had an immediate shooting pain into my arm and down to wrist and fing... Read more
Upon receiving the injection I had an immediate shooting pain into my arm and down to wrist and fingers. The shot was painful whereas my 1st shot I did not feel anything. I continued to have numbness in my fingers of my left hand as I waited the 15 minutes I was asked to wait. I went and discussed with the pharmacist that administered the shot and she said that it wasn't an allergic reaction and that I gave me the information to report to VAERS. I have continued to have the feeling since the shot was administered and it has not improved with the tips of my left hand fingers remaining numb/tingling.
54 2021-06-24 seizure according to her mother, 30 minutes after administration of the vaccine, the patient had a "mini sei... Read more
according to her mother, 30 minutes after administration of the vaccine, the patient had a "mini seizure" that lasted about a minute . Mom called the doctor's office and the doctor didn't think it was related to the vaccine but the mom wanted us to report it
54 2021-06-26 feeling hot Extreme lethargy, body felt hot no fever, chills, joints pain, dizziness, large swelling of the left... Read more
Extreme lethargy, body felt hot no fever, chills, joints pain, dizziness, large swelling of the left side lymph nodes from armpit to breast hard and painful at touch.
54 2021-06-28 muscle spasms Woke up with cramp in right leg and I have been doing (Name) diet and that's not unusual and so I di... Read more
Woke up with cramp in right leg and I have been doing (Name) diet and that's not unusual and so I didn't think anything of it. It happened a few mornings, Thursday 17th, I stayed home from work because I had a really bad headache. Thursday evening, I had a scheduled massage - and he worked on it (the cramp in my leg) and it felt better. Friday morning, I woke up with a headache again and decided to stay home again and around noon my headache went away and I went to grab lunch with my family but while getting ready- I felt a constricting around my chest, hard to breath and pulse was really fast, too. That calmed down in a few minutes and I didn't think anything of it. I couldn't seem to catch my breath after that and so when we got home, I called nurse line. Advised to go to the ER -they thought it was a cardiac event. Found blood clots with the testing they did. Treated with blood thinners - IV drip with Heparin. Continuing to take blood thinners - they gave me Eliquis. They had me quit the birth control pills - So I had bleeding the next week - but all of it was normal. I'm still home from work - I still get really tired when I walk around for any period of time. I cannot bend over when my head is done. If I do that, my breathing gets really short and I have to sit down.
54 2021-06-28 tingling Right after shot started to have a unbearable pain in the left side down ribs and tightest in chest ... Read more
Right after shot started to have a unbearable pain in the left side down ribs and tightest in chest and having tingling in face and down arm. Having a feeling like someone is tightening muscles in arm. Has gotten a EKG and everything was normal there.
54 2021-06-29 burning sensation sensation of chest tightness; burning sensation; This is a spontaneous report from a contactable Oth... Read more
sensation of chest tightness; burning sensation; This is a spontaneous report from a contactable Other Health Professional. A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported) via intramuscular route of administration, administered in Left Arm on 16Jan2021 at 14:30 (at the age of 54-years-old) as Dose number unknown, single for COVID-19 immunization at Hospital. The Patient had sulfa allergies. Concomitant medications included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.On 16Jan2021,at 14:30,the patient experienced sensation of chest tightness, burning sensation.It was reported that no therapeutic measures were taken for the events experienced.The outcome of events not recovered/not resolved. Information on the lot/batch number has been requested Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
54 2021-06-29 feeling hot Client received the 1st dose of the COVID vaccine (Pfizer Lot #EW0187 expiration date 07/10/2021) at... Read more
Client received the 1st dose of the COVID vaccine (Pfizer Lot #EW0187 expiration date 07/10/2021) at 1534. At 1552, the client's friend walked up to the EMT station and asked, "she's feeling dizzy, can we move her to the back chair?" EMT and PHN escorted the client to the zero gravity chair. The client stated, "I'm feeling a little hot, and dizzy. My heart is racing. I think it's just psychological." Client alert and oriented times four. Vital signs taken at 1552 (blood pressure 148/90, heart rate 75, oxygen 95%). Client stated, "I'm afraid of needles. I ate a little before right before coming to my appointment." Client denied SOB. Vital signs taken at 1602 (blood pressure 122/84, heart rate 69, oxygen 96%). At 1602, client stated, "I don't feel dizzy anymore." Vital signs taken at 1612 (blood pressure 122/84, heart rate 70, oxygen 96%). Client is allergic to Codeine, "and some foods." Client stated, "I'm missing some organs. I don't have my thyroid or spleen anymore." Client is currently taking Thyroxine. Vital signs taken at 1622 (blood pressure 130/86, heart rate 66, oxygen 96%). PHN provided education to the client on when to seek emergency services, and to follow up with her primary care provider. At 1623, client stated. "I feel fine," and left the facility unassisted with a steady gait.
54 2021-06-29 night sweats, hot flush Multiple daily and nightly heat flashes; Terrible nights sweats; Tired; This is a spontaneous report... Read more
Multiple daily and nightly heat flashes; Terrible nights sweats; Tired; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the right arm on 04Mar2021 at 14:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included Diabetes, neuropathy, radiculopathy, chronic back and leg pain. The patient had penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received medication within 2 weeks of vaccination but unspecified. On 04Mar2021 at 01:00, the patient had no fever and did not fell ill but was tired for about 2 days and had terrible nights sweats for the first and second nights and at the time of report continued to have multiple daily and nightly heat flashes. The patient completed menopause, so she did not believe it was related to it. No therapeutic measures were taken as a result of adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events multiple daily and nightly heat flashes, terrible nights sweats and tired were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
54 2021-06-29 pain in extremity, migraine Migraine/headache through the night starting around 9pm and into the next day; Ache in arm; This is ... Read more
Migraine/headache through the night starting around 9pm and into the next day; Ache in arm; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the right arm on 20Mar2021 at 13:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included bronchiectasis and migraines due to winter/pressure (haven't had a migraine in weeks as winter was over). The patient did not have any allergies to food, medications, or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. On 20Mar2021 at 21:30, the patient experienced migraine/headache throughout the night and into the next day (21Mar2021). The patient had no idea how long this would last. The patient also experienced ache in arm on 20Mar2021 but was not concerned. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events pain in arm and migraine headache was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
54 2021-06-29 pain in extremity Nausea; Fatigue; Arm pain; Confusion; This is a spontaneous report from a contactable consumer, the ... Read more
Nausea; Fatigue; Arm pain; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 20:15 as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroiditis, history of lung cancer, gastro-oesophageal reflux disease (GERD) and high cholesterol. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient is allergic to latex. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested positive for COVID-19 since having the vaccine. On 20Mar2021 at 05:00, the patient experienced nausea, fatigue, arm pain and confusion. No treatment was received for the events. Event had not resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome for nausea, fatigue, arm pain, confusion was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
54 2021-06-29 pain in extremity Pain in both lower extremity; Swelling in both lower extremity; Red spots; Hives; This is a spontane... Read more
Pain in both lower extremity; Swelling in both lower extremity; Red spots; Hives; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6205) via an unspecified route of administration in left arm on 18Mar20219 (at the age of 54 years old) at 14: 00, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 15:00, the patient experienced pain and swelling in both lower extremity, red spots and hives. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of pain and swelling in both lower extremity, red spots and hives was not recovered at the time of reporting. It was reported unknown whether the patient received any therapeutic measures. No follow-up attempts are needed. No further information is expected.
54 2021-06-30 weakness, pain in extremity Covid-19 diagnosis; Covid-19 diagnosis; still feeling weak; short of breath; swelling; pain in her a... Read more
Covid-19 diagnosis; Covid-19 diagnosis; still feeling weak; short of breath; swelling; pain in her arms and in her back; pain in her arms and in her back; dark black spots on her stomach and legs where the knots were; knots in her stomach; rash in her stomach; This is a spontaneous report received from a contactable female consumer. A 54-year-old female patient received second dose of bnt162b2 (Formulation: Solution for injection PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 22Apr2021 14:30 (at the age of 54-years-old) as dose 2, single and received first dose via an unspecified route of administration, administered in Arm Left on 01Apr2021 14:30 (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunisation. Medical history included ongoing blood pressure high (Has had for over 30 years), diabetes mellitus from 2020 and ongoing and covid-19 from 24Feb2021 to an unknown date. The concomitant medications were not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date the patient experienced covid-19 diagnosis, covid-19 diagnosis, still feeling weak, short of breath, swelling, pain in her arms and in her back, pain in her arms and in her back and dark black spots on her stomach and legs where the knots were. On 26 Apr2021 the patient experienced knots in her stomach and rash in her stomach. It was reported that she is still feeling weak and short of breath as a result of Covid-19 diagnosis?. It was reported that she is still having symptoms of Covid that she had on 24Feb2021. After getting the Covid 19 vaccine, she had knots in her stomach and a rash. Her doctor gave her pain medicine and some cream to resolve it. The patient reported that she went to see the doctor and he said that it didnt look it came from the shots; he thought it was a riser. She reported that knots went down by themselves, she didn't even get the cream he prescribed for her. But she still has dark black spots on her stomach and legs where the knots were. The first spot she noticed was under her bra after she got the 1st dose of the Covid 19 vaccine, and the knot was real hard. She thought it was just a side effect from the 1st shot. She did not tell the doctor about that and was just monitoring it. When she got the 2nd dose, another spot popped up, and that's when she called him and let the doctor know. She reported that the swelling and the knots have gone down; she just has the dark black spots where the knots were that are left. She never got the cream because she couldn't afford the cream that the doctor prescribed. She had pain in her arms and in her back and was given muscle relaxer for that and Tylenol. The name of the cream the doctor prescribed was Mupirocin cream, but she never used it. Therapeutic measures were taken as a result of pain in her arms and in her back. The patient visited physicians office on 26Apr2021 and not emergency room. The patient had no relevant test, no family medical history. The patient had no prior vaccinations. The patient was not vaccinated with any other vaccine on the same day. The outcome of the event knot in her stomach and rash in her stomach were resolving, for rest of the events the outcome was unknown. Follow up needed, further information has been requested.
54 2021-06-30 discomfort Fist even was a mild reaction of soreness at sight, odd metallic taste for about a week. Second dose... Read more
Fist even was a mild reaction of soreness at sight, odd metallic taste for about a week. Second dose I began with with pain and swelling in my lymph glands under the arm where injection was given. I went to the clinic after several days of this worsening. Instructions per dr were to let it ride for another couple of days so my natural immunity could do it's job. But, if worsened to return. They called with follow-up. Swelling had subsided, and pain lessened. But, it spread to other lymph on the left side. Additionally, I had an odd taste again. The immune system was working but pain only lessened about early June. On June 16, 2021, I awoke with a pain in my center chest, like a pulled muscle. It has since spread across my diaphragm area under the breasts. This may or may not be related. It is still uncomfortable but not as severe today, at 2 weeks+. I had my least clear mammogram on March 4,2021 (3D) prior to March 9, 2021 first COVID19 injection.
54 2021-07-01 facial paralysis Bell's Palsy symptom, face drooped on left side, diagnosed at ER on 3/18/2021 after several tests ru... Read more
Bell's Palsy symptom, face drooped on left side, diagnosed at ER on 3/18/2021 after several tests run to rule out a stroke. Was given anti viral meds and steroids for 7-10 days. Physical therapy for face. Treatment for 2 mos. Ongoing at home treatment on face and speech therapy.
54 2021-07-01 pain in extremity sore left arm; fatigue; mild headache; This is a spontaneous report from a contactable consumer, the... Read more
sore left arm; fatigue; mild headache; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6755) via an unspecified route of administration in the left arm on 23Mar2021 at 10:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was allergic to inderal (MANUFACTURER UNKNOWN), amoxicillin (MANUFACTURER UNKNOWN), erythromycin (MANUFACTURER UNKNOWN) and moxifloxacin (AVELOX). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 01Mar2021 at 10:30, as a single dose for COVID-19 immunisation. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), liraglutide (SAXENDA) and methylphenidate (MANUFACTURER UNKNOWN); all for unknown indication and from an unknown date. The patient also received eletriptan (MANUFACTURER UNKNOWN) for headache from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient had not been tested for COVID-19. On 23Mar2021 at 13:00, the patient experienced sore left arm, fatigue and mild headache. It was reported that headache was not likely caused by the vaccine. The patient had long history of headache and recently had headache a week prior to vaccination and took eletriptan. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events pain in arm, fatigue and mild headache was recovered on an unknown date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
54 2021-07-02 weakness, pain in extremity Severe arm pain for 2 days post vaccine. Muscle atrophy, pain and weakness 3 weeks post vaccine.
54 2021-07-02 pain in extremity, numbness Left ear and left side of face from my eye toward ear went numb/Numbness; Left ear and left side of ... Read more
Left ear and left side of face from my eye toward ear went numb/Numbness; Left ear and left side of face from my eye toward ear went numb/Numbness; hands swelled/Hands are still showing swelling on day 7; terribly sore arm; light headed; chills(but no fever); This is a spontaneous report from a contactable consumer or other non health care professional(Patient herself) of 54-year-old (non-pregnant) female patient received the first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 09Apr2021 08:15 (at the age of 54-years-old) at a single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included none and Concomitant medications were not reported. No Known allergies reported. No Allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021, the patient experienced Left ear and left side of face from my eye toward ear went numb, hands swelled, had to take jewelry off. Numbness went away by next morning. Hands were still showed swelling on day 7, still not able to put jewelry on. She had some Normal side effects earlier in the day, terribly sore arm, light headed, chills (but no fever). No treatment was received for the events caused. The outcome of events was recovering. Information on the lot/batch number has been requested.
54 2021-07-03 tingling, numbness After second dose- I experienced worsening Inflammation and intense pain within 2 days of getting VX... Read more
After second dose- I experienced worsening Inflammation and intense pain within 2 days of getting VX. This lead to inability to move head/neck side to side or lift arm. tingling sensation traveling down arm and into fingertips. Numbness of fingertip "pad". Muscle knots/maybe lymph node knots peaked at 6 weeks and slowly decreased by week 12. Numbness and tingling started around week 4 peaked at week 7 and slowly slowly went away by week 12.
54 2021-07-06 pain in extremity, numbness Burning pain in left arm. Numbness left face, arm and lower extremity. Pain in wrist and ankle swell... Read more
Burning pain in left arm. Numbness left face, arm and lower extremity. Pain in wrist and ankle swelling.
54 2021-07-06 pain in extremity Right after the vaccine, I had a very mild sore arm. I started having symptoms in March around the 2... Read more
Right after the vaccine, I had a very mild sore arm. I started having symptoms in March around the 20th. My symptoms became more intense. I tried to avoid going to the ER . I couldn't find anybody that could fit me in. I ended up going to the ER. It hurt to breathe on the left side of my chest. They diagnosed Pleurisy. I took 4 days of Ibuprofen and that fixed it. I really don't think this had anything to do with the vaccine because it started a couple weeks after my first vaccine. I didn't have any symptoms from the 2nd vaccine.
54 2021-07-07 weakness Pain ,bruise bleeding rashes.Loss of energy heart palpitations.
54 2021-07-07 pain in extremity Woke up on May 24, 2021 at around 445 am in excruciating pain very localized on my left thigh. The ... Read more
Woke up on May 24, 2021 at around 445 am in excruciating pain very localized on my left thigh. The pain was o intense I could walk sit or stand. Was take to the hospital by ambulance where I passed out from the numerous times. I explained the pain as burning as if my thigh was about to explode. They gave me lots of different medicine a scan where we were told it was my L5 or potential constipation. A few days passed and I went to several stat cares with no answers. About 7 days later I went to the Care Clinic where they tested me for my Fdimer and it proved elevated so they did a dopplor test with no visible clots. I was sent home with more medicine and a few days later ended up in the emergency room at Spohn South where I kept passing out from the pain. After some more x-rays and exams we were told that I had my l2 L3 bulging and that I need to see a spine specialist. Sent me home with more medicine. I was told to called Dr. at The bone and Joint office and Dr. saw me and gave me steroids and more pain meds. 2 weeks later no change I was barely able to walk and I finally got in to see the right Dr. which was Dr. he evaluated me ran his own exam and MRI and after 2 weeks he along with other s doctor determined it was a side affect due to the vaccine.
54 2021-07-08 pain in extremity, weakness 103.4 fever, severe body aches, headache,chills, muscle pain, extreme fatigue and tiredness, nausea,... Read more
103.4 fever, severe body aches, headache,chills, muscle pain, extreme fatigue and tiredness, nausea, diarrhea, feeling unwell, muscle weakness, arm pain with swelling and itching and now possible shortness of breath
54 2021-07-08 pain in extremity Sore arm/sholder at first. Gradually affecting mobility - unable to lift my arm above my head or pu... Read more
Sore arm/sholder at first. Gradually affecting mobility - unable to lift my arm above my head or put in certain angles/positions. To the point where I'm now struggling to hook/unhook my bra as it's painful reaching back.
54 2021-07-08 tingling On the day of the first vaccine and then on July 4th and July 7th, I got hives. Each time I felt li... Read more
On the day of the first vaccine and then on July 4th and July 7th, I got hives. Each time I felt like I suddenly had a terrible sunburn. On the day of the first vaccine, it was just my face - turned red and was hot to the touch. I assumed it just a fever. On July 4th and 7th, I again felt like I had a terrible sunburn. But on these occasions it was my entire face and my arms. They were bright red, hot to the touch, and painfully tingly. I've been tested for allergies and they found none.
54 2021-07-09 numbness, pain in extremity, tingling 10 days after the second injection, I went to the hospital because I had abdominal pain and had been... Read more
10 days after the second injection, I went to the hospital because I had abdominal pain and had been throwing up. They found blood in my urine, but no other reason for the right flank pain or abdominal pain. At one point my arms were swollen and would wake me up with intense pain - tingling and numb Lyme Disease - Doxy for a 4 weeks - no help, not retested for it 2 UTIs - Ciprofloxacin (500 mg - 10 days) and another antibiotic before that
54 2021-07-09 pain in extremity Severe and constant pain in left arm. Extreme loss of motion and use of left arm.
54 2021-07-10 weakness, nerve injury, speech disorder bruises on her ribcage; heart stopped; weakness; uncontrollable urine; dehydrated; couldn't get up o... Read more
bruises on her ribcage; heart stopped; weakness; uncontrollable urine; dehydrated; couldn't get up off the floor/having trouble walking; they weren't sure what was going on with her, her bladder; downhill from there; couldn't get out of car; can't hold the phone very long, and can't sit up for very long either; hearing loss and can't hear the consonants; superficial blood clot in left leg; L5 compression fracture; claustrophobic; had a hard time pronouncing the letters; affected all of her nerves/all the nerve damage; arthritis everywhere; scaring her; very painful/physical in pain; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0179), at the age of 54 years old, in left arm on 14May2021 at single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD) (diagnosed in 1995, 1996, 2000, been for years, unsure of exact year), bipolar disorder (a mental disorder; a cross between bipolar disorder and PTSD; last hospitalization for this was in Jan2019), carpal tunnel in right and left hand (being treated for this prior to the shot), lower back injury (took paracetamol (TYLENOL) for a lower back injury from about 30 years ago, she fell down a flight down of stairs with her daughter, when she was first born, states her daughter will be 34 at the end of this month. Caller stated she saw an orthopedic doctor, who said not to do anything about it, just keep taking what she's taking), blood pressure abnormal (diagnosed about 5-7 years ago), diabetic non-insulin dependent from 2015 (also provided hypoglycemia as a medical condition), sleep apnea (diagnosed about 15 years ago), history of blood clots, allergies to two muscle relaxers (unknown drug name), fall in Apr2021 (Sunday, being treated). Concomitant medications included lorazepam (ATIVAN) taken for PTSD and mental disorder at 0.25 mg three times a day as needed, paracetamol taken for carpal tunnel, general pain and back injury at 1000 mg every day in the morning, and furosemide for blood pressure abnormal at 40 mg daily as needed; usually takes half, 20 mg. The patient previously received the first dose of BNT162B2 (lot number: EW0169), at the age of 54 years old, in left arm on 23Apr2021 at single dose for COVID-19 immunisation and experienced some events. Caller stated she took the first shot on 23Apr2021, and didn't have too bad of reaction, just like a little bit of the flu. Caller stated in between first shot and just before the second shot, she had some reactions, and in and out of the hospital quite a few times, trying to figure out what was going on. Caller stated she was at hospital on 13Apr2021, 14Apr2021, and then 15Apr2021. Caller stated they had to code her, she'd been unable to work, it had set off arthritis from the top of her head to the bottom of her feet, it's pretty much crippled her to point to where they'd figured out that it was the covid shot that the side effects. Caller stated she just saw her family doctor yesterday, finally able to go in and see her physically, and she had piles of paperwork she'd having to go through, and that was why she started back with paperwork from hospital, dated 15Apr2021. Caller stated she had the shot on 23Apr2021. Caller confirmed first shot was 23Apr2021. Caller stated there was more, it was just started a bunch of things, she was got stacks of papers, and she was sicker than a dog right now, because she got an infection just after, not sure if it was tied into this. Caller stated she was having trouble thinking at times, had caused nerve damage, where she could barely hold the phone. Caller stated she was pretty much grounded; this was the first time she'd been able to get into her apartment, because she couldn't get up the stairs, so she had all the time in the world right now. Caller stated she was a home health aide, clarifies not a nurse. But she'd recently been working, and was emailed papers for the type of leave for COVID-19, and extended leave of absence from work. Caller stated the last time she worked was 05Apr2021, seventh, ninth, tenth, something like that. Caller stated she could't think right now; she'd in and out of it due to medications. Caller provided a health department as healthcare professional site. Caller added on 15Apr2021, she had family and her boyfriend, someone tested positive, so from 13Apr until 27Apr, she quarantined herself in a hotel, close to her work. Caller initially provided date of second dose as three weeks after first dose on 15May2021, but then clarified correct date as 14May2021. Caller stated she was just taking her normal medications, and stated she did not want to go through those at this minute. Caller stated she had an appointment to get first shot, but they spelled her name wrong, and a VIP thing had to be done. Before she went to get the shot she was trying to ask the medical doctor some questions because she had concerns, but before she could tell them any part of her history, the doctor just said to go ahead and gave her the shot. Caller stated the reason she got the number for Pfizer was from when, on 15Apr2021, they tested her for covid, and gave her instructions, she was off of work. Caller clarified she never got a phone call, when agent asked for test results of the test. Caller confirmed this test was done before her shot. Caller stated she got first shot and a couple days later, it was the normal flu-like body aches; she was told to got to store and get stuff for allergies, and for the flu, but she already had paracetamol and diphenhydramine hydrochloride (BENADRYL) for allergies. Caller clarified she was told this by the site which gave the shot, had them sit down and wait 15-20 minutes, then let them go, and told them what to do. Caller stated these symptoms only lasted a couple of days. Caller stated that she didn't remember if she actually took the paracetamol and diphenhydramine hydrochloride as treatment for the flu-like body aches. Caller stated that she had all this paperwork that was going back to 15Apr2021, and she did not remember at the moment what she took for treatment of symptoms. Caller states she had everything journaled written down, stated in between the first and second shot, she was in and out of emergency rooms, trying to figure out what was going on. States she had to go back she was having reactions, she was in the emergency room for weakness, and other things, and had to be checked for blood clots, so she had to go back. She was there on 13May2021, 14May2021, they did a venous doppler on everything because she was having all kinds of pain in legs. Then on 15May2021, she had to go back to be checked for something, right after she got out of emergency room, and after she had the test, she was medically transferred to get the second shot (corrected on 14May2021), and after she got the second shot, it's been downhill from there. Caller stated she was admitted into a hospital and was in and out of the hospital. Caller stated she coded, they had to do CPR on her, and this had affected all of her nerves. Caller stated they gave both shots in her left arm and it had set off everything and all the nerve damage. Caller stated this was scaring her because she was the only family member who had the Pfizer shot. Everybody else was out of the state, and had the Johnson and Johnson or all the other vaccines, and she was the only one who'd this shot, and the one who had the most damage. Call handler made multiple attempts to clarify information provided and get further details but asked to move on because all the questions were setting her off. Caller stated maybe she should have had the case worker call. Caller clarified she did not have arthritis prior to this. Caller stated 31May2021, she was rushed to a hospital because she couldn't get up off the floor, they weren't sure what was going on with her, her bladder, so they put her on prednisone for a week. Caller did not finish statement regarding her bladder. Caller stated all hospitals she had been in, with exception of one. Caller provided a hospital when agent asked for spelling or clarification. Caller stated she could't hold the phone very long, and she can't sit up for very long either. Caller stated she had a hard time pronouncing the letters, when agent asked her to spell the hospital name. Caller stated the problem was agent was on a headset and her phone was set up for handicap for an ear that could't hear properly, so she stated the agent being on a headset was why agent could't hear her. Caller stated she had hearing loss and could't hear the consonants. Caller stated she was due to take medicine and could't take it while on the phone. Caller asked if there a fax number to fax the rest of this to. Caller stated all of the hospitals were all under a health, it was a whole medical group with all different hospitals in different towns. Caller stated prior to emergency room visit, she was in a hospital because she couldn't walk, was having trouble walking. She coded while they were admitting her; her heart stopped and they had to code her. Caller added she had not had a paycheck since 09Apr2021 or tenth, stated landlord hadn't thrown her out but she'd close to being evicted because she hadn't worked, it was been determined the side effects have caused more damage. Caller stated 15Apr2021 she got Pfizer's phone number when she was tested for covid. Caller stated that was when they did the test, but she never heard anything back regarding the results of the test. She quarantined at a hotel and had to be away from work. Caller stated it was been a hospital where it started. Caller stated maybe agent needed to call back and finish report because she had all of hospital papers dissected with dates. Caller stated she was given a huge packet on 15Apr2021, when she was tested for covid. Went to the only local medical facility, and she went there on 15Apr2021 because her boyfriend's sons' girlfriend tested positive, and they gave her a note for her work with instructions. Caller clarified they gave her a huge packet so that was where she got all the paperwork in Apr2021 before she got the shot. Caller stated after the first shot she had 48 hours of hot flashes, the chills, typical flu-like symptoms; only lasted 48 hours, and then from the twenty third she had different symptoms, and had been in an out of hospitals, trying to figure out what was going on with her. Caller stated she was healthy and working until 07Apr2021, 08Apr2021, or 09Apr2021, was the last time she worked. Then she quarantined from 13Apr2021 until 27Apr2021, and then they had to get vaccinated, so she registered, and when she went there, they spelled her name wrong, she started asking questions trying to give medical history before the shot. She had not given any of her history and doctor said to just give it. They gave the shot in her left arm and from then on, the damage hit and it has been one thing after another. Caller stated she previously had a test done in 2017, electrical shock from toes to head, and acupuncture same day, and only thing showed up was carpal tunnel in right and left hand. She was being treated with 1000 mg paracetamol, and she was fine working since 2018. Caller stated she was physically fine and is 54 years old, the oldest one working there and now she'd been back and forth from hospitals. Caller stated she was in the hospital with weakness 10Jun2021 or 07Jun2021. Caller stated this had been a continuous thing going to hospitals for weakness, bladder is just letting go like just having uncontrollable urine, she got dehydrated. She only had to be inpatient at hospital. Caller stated right after admitted there, primary doctors found a superficial blood clot in left leg and started her on rivaroxaban (XARELTO), and they discharged her and transferred her by med car from main hospital to the emergency room satellite. She was there to do an MRI and had to sedate her because she was claustrophobic. They found an L5 compression fracture, which caller clarified was new since the shot. Caller stated the back specialist said not going to do anything it, it will heal on it was own. Caller stated she was sent to get her car and had a major allergic reaction to a drug given while in hospital but the nurse didn't listen, they let her drive her car, which is satellite for hospital. Caller stated she stopped, paid for diphenhydramine hydrochloride and had to park the car while she took two diphenhydramine hydrochloride for having major symptoms. Caller stated when she felt she was ok, she drove back to hotel, but when she got there, she couldn't get out of car so the manager called 911, and withheld came and assessed her. Her cognitive level was fine, but she was sitting in urine and couldn't get out of car, so they rushed her to a hospital and she was admitted on an orthopedic floor, this was 20May2021 or 21May2021, and she went unresponsive while they were admitting her, so they coded her. Caller stated that she still had bruises on her ribcage. A cardiologist came and actually he listened to her. They did three different cat scans and determined that she now has arthritis everywhere. It's very painful. States that she is sitting with 5 piles of paperwork from 15Apr to her most current one which would have been at hospital just a couple of days ago. She has been diagnosed with so many different things because the doctor's couldn't figure out what was going on. Call handler attempted to query the name of the medication that caused her allergic reaction. Caller stated that there are 4 medications that she reacts to, two are muscle relaxers that she was allergic to, and one of them was given to her at a hospital. Caller stated that the problem was that people looked at your mental disabilities first, they did't look at your other history, and nurses were over worked, so even though she told the nurse to call her doctor because she was having a major reaction and she knew what it was, they were still discharging her. Call handler again asked for the name of the product. Caller became upset and stated that she was physically in pain. No follow-up attempts are possible. No further information is expected.
54 2021-07-10 hot flush, pain in extremity, nerve injury, weakness heart stopped, had to code her; weakness; Caller states she is pretty much grounded/because she coul... Read more
heart stopped, had to code her; weakness; Caller states she is pretty much grounded/because she couldn't get up the stairs/couldn't get up off floor/having trouble walking; pretty much crippled her; superficial blood clot in left leg; having trouble thinking; compression fracture L5; hot flashes; chills; set off arthritis from top of head to the bottom of her feet; arthritis in every bone ever broken; Dehydrated; Uncontrollable urine; nerve damage, where she can barely hold the phone; because she was having all kinds of pain in legs.; the normal flu-like body aches / just like a little bit of the flu; she had family and her boyfriend, someone tested positive; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received the first dose of BNT162B2 (, Lot No. EW0169) at Left arm at single dose for COVID-19 immunisation on 23Apr2021 (54-year-old at vaccination). Relevant history included PTSD (diagnosed in 1995, 1996, 2000, been for years, unsure of exact year), Bipolar disorder (a mental disorder; a cross between bipolar disorder and PTSD (Post-traumatic stress disorder); last hospitalization for this was in Jan2019), Carpal tunnel in right and left hand (being treated for this prior to the shot), lower back injury (took Tylenol for a lower back injury from about 30 years ago, she fell down a flight down of stairs with her daughter, when she was first born, states her daughter will be 34 at the end of this month. Caller states she saw an orthopedic doctor, who said not to do anything about it, just keep taking what she's taking), Blood pressure abnormal which was diagnosed about 5-7 years ago, diabetic non-insulin dependent, also provided hypoglycemia as a medical condition, Sleep apnoea which was diagnosed about 15 years ago, history of blood clots, fall in Apr2021 (Easter Sunday, being treated). Relevant concomitant drug included lorazepam (ATIVAN) for PTSD and mental disorder, paracetamol (TYLENOL) for carpal tunnel and general pain and she had a lower back injury, and furosemide for blood pressure abnormal. On 23Apr2021, the patient took the first shot, and didn't have too bad of reaction, just like a little bit of the flu. Caller states in between first shot and just before the second shot, she's had some reactions, and in & out of the hospital quite a few times, trying to figure out what's going on. Caller states she was at place on 13Apr, 14Apr, and then 15Apr. Caller states they had to code her, she's been unable to work, it has set off arthritis from the top of her head to the bottom of her feet, it's pretty much crippled her to point to where they've now figured out that it is the covid shot that the side effects. Caller states she just saw her family doctor yesterday, finally able to go in and see him physically, and she has piles of paperwork she's having to go through, and that's why she started back with paperwork from # Hospital, dated 15Apr. Caller states she had the shot on 23Apr. Caller confirms first shot was 23Apr2021. Caller states there's more, it's just started a bunch of things, she's got stacks of papers, and she's sicker than a dog right now, because she got an infection just after, not sure if it's tied into this. Caller states she's having trouble thinking at times, has caused nerve damage, where she can barely hold the phone. Caller states she is pretty much grounded; this is the first time she's been able to get into her apartment, because she couldn't get up the stairs, so she has all the time in the world right now. Reporter details: Type: Caller states she is a home health aide, clarifies not a nurse. But she's recently been working with #, and #, and was emailed papers for the type of leave for COVID-19, and extended leave of absence from work. Caller states the last time she worked was 05Apr, seventh, ninth, tenth, something like that. HCP details: Caller states she can't think right now; she's in and out of it due to medications. HCP Email: Caller declines to provide. Patient details: Caller provided name at the beginning of call as #. Height: States, depends on who's measuring it, five two, five three, five one. Caller clarifies as five two. Product: Caller confirms the product as Pfizer covid shot. Caller states she had to get vaccinated because it was required. First dose: 23Apr2021, Lot EW0169, NDC and Expiration Date: Unknown, Left arm Second dose: 14May2021, Lot EW0179, NDC and Expiration Date: Unknown, Left arm. Caller adds on 15Apr, she had family and her boyfriend, someone tested positive, so from 13Apr until 27Apr, she quarantined herself in a hotel, close to her work. Caller initially provided date of second dose as three weeks after first dose on 15May2021, but then clarifies correct date as 14May2021. History: Caller states she was just taking her normal medications, and states she does not want to go through those at this minute. Caller states she had an appointment to get first shot, but they spelled her name wrong, and the # had to do a VIP thing. Before she went to get the shot she was trying to ask the medical doctor from the # some questions because she had concerns, but before she could tell them any part of her history, the doctor just said to go ahead and give her the shot. States the reason she got the number for Pfizer was from when, on 15Apr, she went to #, to begin with, and they tested her for covid, and gave her instructions, she was off of work. Caller clarifies she never got a phone call, when agent asks for test results of the test. Caller confirms this test was done before her shot. Event details: Caller states she got first shot and a couple days later, it was the normal flu-like body aches; she was told to got to store and get stuff for allergies, and for the flu, but she already had Tylenol and Benadryl for allergies. Caller clarifies she was told this by the #; they gave the shot, had them sit down and wait 15-20 minutes, then let them go, and told them what to do. Caller states these symptoms only lasted a couple of days. States that she doesn't remember if she actually took the Tylenol or Benadryl as treatment for the flulike body aches. States that she has all this paperwork that is going back to 15Apr, and she does not remember at the moment what she took for treatment of symptoms. Caller states she has everything journaled written down, states in between the first and second shot, she was in and out of emergency rooms, trying to figure out what was going on. States she had to go back to medical facility because she was having reactions, she was in the emergency room for weakness, and other things, and had to be checked for blood clots, so she had to go back. She was there on 13May, 14May, they did a venous doppler on everything because she was having all kinds of pain in legs. Then on 15May, she had to go back to be checked for something, right after she got out of emergency room, and after she had the test, she was medically to get the second shot, and after she got the second shot, it's been downhill from there. Caller states she was admitted into # Hospital, and was in and out of the hospital. States she coded, they had to do CPR on her, and this has affected all of her nerves. Caller states they gave both shots in her left arm and it has set off everything and all the nerve damage. Caller states this is scaring her because she is the only family member who has had the Pfizer shot. Everybody else is out of the state and had the Johnson and Johnson, or all the other vaccines, and she's the only one who's had this shot, and the one who has had the most damage. Call handler made multiple attempts to clarify information provided and get further details, but asks to move on because all the questions are setting her off. Caller states maybe she should have had the case worker call. Caller clarifies, she did not have arthritis prior to this. Caller states 31May2021, she was rushed to Place because she couldn't get up off the floor, they weren't sure what was going on with her, her bladder, so they put her on prednisone for a week. Caller did not finish statement regarding her bladder. Caller states all hospitals she has been in have been #, with exception of one in #. Caller provides #, when agent asks for spelling or clarification. Caller states she can't hold the phone very long, and she can't sit up for very long either. States she has a hard time pronouncing the letters, when agent asks her to spell the hospital name. Caller states the problem is agent is on a headset and her phone is set up for handicap for an ear that can't hear properly, so she states the agent being on a headset is why agent can't hear her. Caller states she has hearing loss and can't hear the consonants. Caller states she is due to take medicine and can't take it while on the phone. Caller asks if there a fax number to fax the rest of this to. Caller states all of the hospitals, #, are all under #, it's a whole medical group with all different hospitals in different towns. Caller states prior to emergency room visit, she was in # Hospital because she couldn't walk, was having trouble walking. She coded while they were admitting her; her heart stopped and they had to code her. Caller adds she has not had a paycheck since 09Apr or tenth, states landlord hasn't thrown her out but she's close to being evicted because she hasn't worked, it's been determined the side effects have caused more damage. Caller states 15Apr2021 she got Pfizer's phone number when she was tested for covid. Caller states that's when they did the test but she never heard anything back regarding the results of the test. She quarantined at a hotel, and had to be away from work. Caller states it's been # Hospital where it started. Caller states maybe agent needs to call back and finish report because she has all of hospital papers dissected with dates. Caller states she was given a huge packet on 15Apr, when she was tested for covid. at medical facility which is the only local medical facility, and she went there on 15Apr because her boyfriend's sons' girlfriend tested positive and he's in #, and they gave her a note for her work with instructions. Caller clarifies they gave her a huge packet so that's where she got all the paperwork in Apr before she got the shot. Caller states after the first shot she had 48 hours of hot flashes, the chills, typical flu-like symptoms; only lasted 48 hours, and then from the twenty third she's had different symptoms, and has been in an out of hospitals, trying to figure out what was going on with her. States she was healthy and working until 07Apr, 08Apr, or 09Apr, is the last time she worked. Then she quarantined from 13Apr until 27Apr, and then they had to get vaccinated, so she registered, and when she went there, they spelled her name wrong with a # instead of #, she she started asking questions trying to give medical history before the shot. She had not given any of her history and doctor said to just give it. They gave the shot in her left arm and from then on the damage hit and it has been one thing after another. Caller states she previously had a test done in 2017, electrical shock from toes to head, and acupuncture same day, and only thing showed up was carpal tunnel in right and left hand. She was being treated with 1000 mg Tylenol, and she was fine working at #, and #, since 2018. States she was physically fine and is 54 years old, the oldest one working there and now she's been back and forth from hospitals. Caller states she was in # in the hospital with weakness 10Jun2021 or 07Jun2021. Caller states this has been a continuous thing going to hospitals for weakness, bladder is just letting go like just having uncontrollable urine, she got dehydrated. She only had to be inpatient at #Hospital in #. Caller states right after admitted there, primary doctors found a superficial blood clot in left leg and started her on #, and they discharged her and transferred her by from main hospital to the emergency room satellite. She was there to do an MRI and had to sedate her because she's claustrophobic. They found an L5 compression fracture, which caller clarifies is new since the shot. Caller states the back specialist said not going to do anything it, it will heal on it's own. Caller states she was sent to get her car and had a major allergic reaction to a drug given while in hospital but the nurse didn't listen, they let her drive her car from ##, which is satellite for # Hospital. States she stopped at a #, paid for Benadryl and had to park the car while she took two Benadryl for having major symptoms. Caller states when she felt she was ok, she drove back to hotel, but when she got there she couldn't get out of car so the manager called 911, and # they came and assessed her. Her cognitive level was fine, but she was sitting in urine and couldn't get out of car, so they rushed her to # Hospital and she was admitted on an orthopedic floor, this was 20May or 21May, and she went unresponsive while they were admitting her, so they coded her. States that she still has bruises on her ribcage. A cardiologist came and actually he listened to her. They did three different cat scans and determined that she now has arthritis in every bone ever broken. It's very painful. States that she is sitting with 5 piles of paperwork from 15Apr to her most current one which would have been at # Hospital just a couple of days ago. She has been diagnosed with so many different things because the doctor's couldn't figure out what was going on. Call handler attempted to query the name of the medication that caused her allergic reaction. Caller stated that there are 4 medications that she reacts to, two are muscle relaxers that she is allergic to, and one of them was given to her at # hospital. States that the problem is that people look at your mental disabilities first, they don't look at your other history, and nurses are over worked, so even though she told the nurse to call her doctor because she was having a major reaction and she knew what it was, they were still discharging her. Call handler again asked for the name of the product. Caller became upset and stated that she is physically in pain and is getting ready to pee herself right now. Caller started yelling that there are 5 medications that she is allergic to. No further details provided. Caller stated that the next call is going to the governor of #. Call was abruptly disconnected. The outcome of events was unknown.
54 2021-07-10 pain in extremity Shooting pain in her left arm up to her shoulder in the arm she received vaccine; Shooting pain in h... Read more
Shooting pain in her left arm up to her shoulder in the arm she received vaccine; Shooting pain in her left arm up to her shoulder in the arm she received vaccine; It got on her nerves; Exhausted; Injection site was a little sore/Shooting pain in her left arm up to her shoulder in the arm she received vaccine; Weird sensation; Itching in her back; Headache; Wooziness; Nausea/Nausea aggravated/nausea went to the tenth degree; Stiffness in her neck and back; Muscles tighten up; She couldn't move or drive; She couldn't move or drive; This is a spontaneous report from a contactable nurse (patient) via medical information team. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0196) via an unspecified route of administration in left arm on 25Jun2021 (Time of vaccination: Between 18:50 and 19:00; at the age of 54-year-old) as single dose for COVID-19 immunization. Medical history included ongoing hyperthyroidism was diagnosed just a couple weeks ago (Oct2020). They did a nuclear scan test looking for hot and cold spots (unknown results). It has been almost a month now. They did different tests then checked her TSH (thyroid stimulating hormone) which was off a little bit. That's what prompted further tests. The diastolic heart failure was diagnosed back in Oct2020 and ongoing. They did a Holter monitor for so many days. When they got the results that's what he saw. She is real sensitive to a lot of things. She has a lot of allergies and is not one to respond well to things. She has food allergies and is not one to take medicine. She had diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Family History included Blood clotting issues, Factor V, diabetes, hypertension, heart conditions. Concomitant medications were none. She doesn't take any medications. No prior Vaccinations (within 4 weeks). The patient previously took morphine for food poisoning one time she was at the hospital and they tried giving her Morphine and she had a reaction to that. As soon as they gave her the IV it went straight to her head. The same happened with the Lovenox shot. She had a sensation through her body that was not normal. She was in the hospital at that time and it was a couple years back. She is real sensitive which is why she was so scared to get the vaccine. She was worried about the ingredients. Even diphenhydramine hydrochloride (BENADRYL) she not so much as has an allergic reaction as she is sensitive to the medicine. Even paracetamol (TYLENOL) puts her to sleep. Historical Vaccine included influenza vaccine (FLU) shot last September or October and did fine. Also received levofloxacin (LOVENOX) shot and went straight to her head. She had her first dose of the Pfizer Covid-19 vaccine last Friday, 25Jun2021. Since then immediately she experienced headache, wooziness/ real woozy, extreme nausea that went on for hours and hours. At midnight Friday night it took a turn for the worst. She fell asleep, but the nausea was unbelievable. Saturday morning it started subsiding a little, but the nausea stayed the longest. Sunday was a good day, but then today she woke up feeling okay but as the morning wore on she felt a headache, stiffness in her neck and back, and shooting pain in her left arm from her shoulder down her arm like being shocked. Her arm looks okay. It is a weird sensation, the neck and head stiffness. The shooting pain keeps going. Shooting pain in her left arm up to her shoulder in the arm she received vaccine, and itching in her back. Most of her symptoms started 5 to 8 minutes after she had the shot, so around 19:08 to 19:10. She did call the doctor's office. She doesn't know what the stiff neck and shooting pain are. She asked if these symptoms are normal after the vaccine or heard about before. Asked for guidance for what to do. Stated a lot of it happened when she first got the shot, and she felt worse by midnight then fell asleep because she was so exhausted, but on Saturday the nausea still continued. Stated that yesterday, Sunday, she didn't have problems, but today (28Jun2021) when she woke up she was having shooting pain in her left arm and shoulder, which was the arm she received her vaccine dose in. She didn't have pain before in the beginning, and the headache came back as well as stiffness in the neck. Trying to see if this warrants a medical emergency and it is a concern for me. She is a nurse and had delayed reactions. She wanted to make sure hopefully not too problematic. She is a registered nurse. She works for the hospital and has been there for 30 years. She works on the trauma floor post-surgical. If she sees something happening she takes the smallest dose first. She was worried as they first gave her the shot, and her symptoms got worse and her nausea went to the tenth degree at midnight. She left a message at the office and asked to have someone call her, but they were tied up. She hopes someone calls today because she goes back to work tomorrow. She just has concerns because she knows she is sensitive. Her physician is an attending for a family medicine clinic. She didn't know this existed, she just Googled and found this number. It is all on the left side of her body. The headache started immediately after she had the vaccine. It is associated with the weird sensation in her neck. It's almost like it could be the glands, she can't describe it. The headache came back with her stiff neck and left shoulder pain. She didn't feel it yesterday, but today she noticed it cropped back up. She keeps having a stiff neck like working out and the muscles tighten up in Jun2021. Real woozy started immediately after she had the shot. She was woozy, dizzy, crazy. She couldn't move or drive in Jun2021. It was not cool. That went away, and then this morning it just slightly tried to come back a little bit. Extreme nausea started immediately after she had the vaccine. It was a long haul. She had it all Friday night until Saturday afternoon when it subsided. It comes and goes. She felt it just a little bit this morning. It is northing like the first day. On 28Jun2021 (Today) she had more head and neck stiffness and the left arm thing. The injection site was a little sore when she got the shot, but this is different. That's why she called the doctor. The pain is changing for the worse, and it is different. Stiffness in neck and back, she had it right after the shot. Today she has a headache, stiffness in her neck and upper shoulders, and shooting pain. She can't figure out what is going on. It got on her nerves. It is worse than when it started on Friday. Shooting pain in left arm she just noticed that today on 28Jun2021. That is what worried her. It is all into her shoulder and into her forearm. It just hurts differently. It wasn't doing this. Injection site was a little sore: She had just a little bit of soreness. That is different too. Her arm is the alert for her today. She was working yesterday moving patients and turning and elder person all day. She doesn't know if she could have aggravated it moving and turning. She also had itching in her back. It was an internal itching all on the left side of her back. It was like inside her body, not like a scratch on the skin. It was internal itching. It started immediately 5 to 8 minutes after she had the vaccine. It happened again on Saturday afternoon. It is not cool. It was like in her back and spine. She thinks that might be okay now. She knows some of her symptoms are normal. She just kind of had to throw it out there. It is not life threatening, but she shouldn't ignore it. She is concerned because she is sensitive to so much. She can't answer that right now. She needs to let Pfizer be aware. The shooting pain in her arm keeps coming and going almost like being griped. It is in the should and that whole area. It is aggravating. She was 99% sure the Covid shot caused her symptoms. This wasn't happening before. It is her body's way of responding to this for whatever reason. She is worried about the second dose. She started to go to the ER that midnight, but she cried and went to sleep. The nausea went to the tenth degree/nausea aggravated, and she knew something was going on. She wanted to see if her symptoms have been reported and what she should do or watch for. She wants to know if Pfizer has heard this before and if they haven't she is looking for extra knowledge and guidance. A visit to emergency room or physician office was not required. The outcome of events headache, wooziness, nausea, Stiffness in her neck and back, Shooting pain in her left arm up to her shoulder in the arm she received vaccine was Not recovered; Itching was recovered on 26Jun2021; unknown for other events. Event relatedness: events stiffness in neck and back, real woozy, extreme nausea, shooting pain in left arm, injection site was a little sore were assessed as related to Pfizer Covid Shot by reporter.
54 2021-07-11 burning sensation, numbness Go the shot immediately burning down my arm waited :15 minutes to wrist and hand, hand went numb. Wa... Read more
Go the shot immediately burning down my arm waited :15 minutes to wrist and hand, hand went numb. Was told by pharmacy that it was normal later that evening the leg to feet went numb then into the night the entire left side from neck to face to cheek went numb. Face numbness went away after a day in a half. On day six: still having this numbness in arm and leg from the elbow to the hand numbness and the front the knee to the foot numbness on left side. Seems to be resolving with the face numbness resolving.
54 2021-07-11 feeling hot After 4 hours of 1st injection started to feel heat and swelling of face. In the morning woke up t... Read more
After 4 hours of 1st injection started to feel heat and swelling of face. In the morning woke up to red swollen cheeks and eyes. Itching sporadic over entire body. Eczema that was dormant flared on legs and upper arms. Severe headache which did not respond to Tylenol.
54 2021-07-11 seizure, limb paralysis, weakness, involuntary muscle movements I've been having seizures and dyskinesia which is MS related. I've also had weakness and leg paralys... Read more
I've been having seizures and dyskinesia which is MS related. I've also had weakness and leg paralysis so that I have to use walker when I'm out and about and that's all come out since leaving hospital. I've been dealing with terrible fatigue, being winded, having no strength, weakness since leaving hospital on April 20 and it keeps getting worse. I'm seeing my PCP tomorrow 07/13/2021. A week ago I was seeing a hematologist that I got in touch with and she was trying to give me iron to help with anemia even though numbers aren't bad, but I'm so symptomatic since vaccine, but I'm allergic to iron. She tried something else on June 28 and I had an anaphylactic reaction and that was to deal with fatigue and symptoms of anemia. The seizures and Dyskinesia prompted my MS doctor to want me to get a new set of MRIs but because my crohn's is so bad I don't have time to do any of this. Today I was scheduled for July 29 to see where blood clots were formed in my legs from the vaccine. I've been experiencing intestinal hemorrhaging since being on blood thinners, it oozes out of my stoma because I have an ileostomy and that's a new symptom as well. That's probably why my anemia is so bad because I'm having the intestinal hemorrhaging. July 28 I have intestinal scoping.
54 2021-07-12 nerve pain difficulty walking; Shooting nerve pain from hip to foot on right side.; Intense pain; fever; chills... Read more
difficulty walking; Shooting nerve pain from hip to foot on right side.; Intense pain; fever; chills; shortness of breath; nausea; chest pain; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female consumer(patient) reported that: A 54-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 21May2021 at 10:00 (at the age of 54-year-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included known allergy to epinephrine, MRI dye (MRIBUTIN) and Penicillin from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included zolpidem tartrate (AMBIEN) taken for an unspecified indication, start and stop date were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Left arm on 30Apr2021 at 10:00 as single dose for covid-19 immunisation. Patient was not received any other vaccine prior four weeks of vaccination. Patient received Ambien within 2 weeks of vaccination. On 21May2021 at 21:00 the patient experienced difficulty walking, shooting nerve pain from hip to foot on right side, intense pain, fever, chills, shortness of breath, nausea and chest pain. Since vaccination patient not tested for covid-19. This case assessed as non-serious as per reporter. No therapeutic measures were taken as a result of the events. The outcome of the event was reported as recovering. Additional information is requested.
54 2021-07-12 pain in extremity Minimal pain innodes under right arm; Pain in neck.; Very painful, swollen lymph nodes under the lef... Read more
Minimal pain innodes under right arm; Pain in neck.; Very painful, swollen lymph nodes under the left arm.; Pain in left.; Pain in shoulder.; headache; fever; body aches; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 11:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroiditis. Concomitant medications included T3 and T4 thyro meds (medicines). The patient had known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021 at 21:00, the patient experienced very painful, swollen lymph nodes under the left arm. There was minimal pain in the nodes under the right arm. The patient also had pain in the left arm, neck and shoulder. Then the patient experienced headache, fever and body aches for two days following injection. It was reported that lymph nodes under the left arm were still swollen. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included the treatment with ibuprofen. The clinical outcome of headache, fever and body aches was recovered on 28Mar2021; while the outcome for painful swollen lymph nodes under the left arm, painful nodes under right arm, pain in left arm, neck, and shoulder were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
54 2021-07-13 pain in extremity Pain in arm, joint pain, swollen gland in armpit (very painful and large), sensitive skin, fatigue
54 2021-07-13 tenderness, weakness, numbness, tingling woke up only left shoulder pain weakness going down wrist ,fingers numbness, tingling sensitive to ... Read more
woke up only left shoulder pain weakness going down wrist ,fingers numbness, tingling sensitive to touch, cannot lift my arm above my head , went to hospital , one day physical therapy then sent home but still cannot lift my left arm. getting MRI soon
54 2021-07-14 nerve injury, pain in extremity 06/08/21 My arm was hurting doctor wanted to check and see if I don?t have a black cloth he sent me ... Read more
06/08/21 My arm was hurting doctor wanted to check and see if I don?t have a black cloth he sent me to do x-rays but he said he can?t see I need to have a CT scan to see my nervousness damage because I can?t move my arm it hurts
54 2021-07-14 pain in extremity Cardiac event - Elevated heart enzymes, inflamed heart, chills, inability to move neck, joint pain, ... Read more
Cardiac event - Elevated heart enzymes, inflamed heart, chills, inability to move neck, joint pain, pulsating fingers, pain in arms, fatigue, shortness of breath, pain in heart. Hospitalized July 2 to July 4
54 2021-07-17 weakness Sore throat; Achy; bones hurt; Very weak; Itchy; sweats; Fatigued; Chills; This is a spontaneous rep... Read more
Sore throat; Achy; bones hurt; Very weak; Itchy; sweats; Fatigued; Chills; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EPB955) via an unspecified route of administration in the left arm on 23Mar2021 at 09:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Other medications received by the patient within two weeks prior to vaccination included levothyroxine sodium (MANUFACTURER UNKNOWN) and ibuprofen (MOTRIN). The patient had not received any other vaccines within four weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021 at 01:45, sixteen hours after vaccination, the patient experienced sore throat, achy, bones hurt, very weak, fatigued, itchy, chills and sweats. Therapeutic measures were not taken as a result of sore throat, ache, bone pain , weakness, itchy, sweaty, fatigue and chills. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. The clinical outcome of the events sore throat, ache, bone pain , weakness, itchy, sweaty, fatigue and chills was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
54 2021-07-17 breast pain painful, burning lump left breast; Swollen lymph nodes; painful, burning lump left breast/ lot of pa... Read more
painful, burning lump left breast; Swollen lymph nodes; painful, burning lump left breast/ lot of pain with this lump and some slight burning; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN5318, patient was 54-year-old at the time of vaccination), via an unspecified route of administration in Arm Left on 21Apr2021 at 10:00 as single dose for covid-19 immunisation, as she works in a lab and comes into contact with a lot of things and deals with blood. Medical history included, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. No illness/AE and family Medical History Relevant to AE(s) reported. There were no concomitant medications. Patient did not receive prior Vaccinations within 4 weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: GR8733, patient was 54-year-old at the time of vaccination), via an unspecified route of administration in Arm Left on 31Mar2021 as single dose for covid-19 immunisation. It was reported that patient had done some research that showed it could be a side effect and was wondering if it had been reported. She reports that she had seen her HCP and went yesterday for mammogram, and now they want to biopsy the lump. She was asking if it had been reported as she was trying to weigh it out and see what this was. Reported that patient want to know how Long Side Effects Last, specifically Swollen lymph nodes are likely to had resulted from a robust vaccine-elicited immune response. Referred to HCP for guidance on her symptoms. Emailed attached CONS-what are the risks of the vaccine. Reported that she went to the doctor and found out she had a lump in her left breast. When she got there, they asked her if she had taken the shot, and she said yes. She looked up the side effects and that was one of the side effects, a lump in the breast after taking the shot. The lump is the same size. She was having a lot of pain with this lump and some slight burning. She went to the doctor yesterday, and they did a mammogram and an ultrasound. They couldn't tell exactly what it was, and she had to go and do a biopsy. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient experienced painful, burning lump left breast, lot of pain with this lump and some slight burning, swollen lymph nodes on an unspecified date in 2021 and the patient experienced painful, burning lump left breast on 04Jun2021. It was reported that time of Onset (24-hour clock) was about 07:30-08:00. Reporter seriousness for Lump in left breast was unspecified. Patient visited Physician Office for AE(s). No hospitalization was reported. The patient underwent lab tests which included mammogram and ultrasound breast resulted as unknown result, they couldn't tell exactly what it is, Date: 28Jun2021 (Not confirmed). The outcome of event painful, burning lump left breast was not recovered and outcomes of events painful, burning lump left breast/ lot of pain with this lump and some slight burning, swollen lymph nodes was unknown.
54 2021-07-17 facial pain, pain in extremity Headache; face/neck pain; Neck pain; sore arm; Tired; This is a spontaneous report from a contactabl... Read more
Headache; face/neck pain; Neck pain; sore arm; Tired; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 22Mar2021 at 10:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient medical history included high cholesterol and hypothyroidism (low thyroid). Concomitant medications included progesterone (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. The patient has known allergy to hydrocodone and it makes her itchy. Prior to vaccination, patient had not diagnosed with COVID-19. Since the vaccination, patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 18:00 (night at vaccination day), the patient had sore arm and was tired. On 23Mar2021 (second day), the patient was fine but, in the evening, experienced headache with torso and face/neck pain and was fine the third day. Therapeutic measures were taken as a result of the events which included over the counter medication TYLENOL. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events painful arm, tiredness was resolved on 23Mar2021, whereas for events headache, facial pain, neck pain and pain were resolved on 24Mar2021. No follow-up attempts are needed. No further information is expected.
54 2021-07-17 flushing Vertigo; Severe dizziness / Light headedness if I get my heart rate up; Nausia; Body flushing if I l... Read more
Vertigo; Severe dizziness / Light headedness if I get my heart rate up; Nausia; Body flushing if I lay my head down or turn my head quickly; Shortness of breath; Get my heart rate up; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0179) via an unspecified route of administration in left arm on 05May2021 at 15:00 (age at vaccination 54-year-old) at single dose for covid-19 immunization. Patient medical history included Meniere's Disease. The patient's concomitant medications included unspecified medications. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took Levaflozin and had allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0169) on 14Apr2021 (age at vaccination 54-year-old) in left arm as single dose for Covid-19 Immunization. The patient previously took the shingles vaccine and experienced shortness of breath, nausea, light headedness, vertigo, flushing and heart rate increased. Patient have Menieres Disease. Prior to the vaccine, patient not had vertigo or severe dizziness for over 6 months. On 12May2021 at 15:00, one week after second shot patient had 2 bad cases of vertigo within 2 days of each other. Patient was put on Prednisone 2 weeks after the shot to calm the reaction. Patient continued to experience nausea, dizziness, and body flushing if she lays her head down or turn her head quickly. She also experienced shortness of breath, nausea, and light headedness if she gets her heart rate up. Patient experienced this same reaction after the shingles vaccine. It lasted 12 weeks. She was hoping for the same and she was currently 6 weeks out. Adverse events resulted into Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a resukt of events with prednisone. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.
54 2021-07-17 migraine had cold chills for day or two; At night, she saw a red circle with nothing in center and could see ... Read more
had cold chills for day or two; At night, she saw a red circle with nothing in center and could see around it, which moved as her eyes moved/started to see spots and blue lines/eyes are not working; dry eyes; blurred vision; She felt she is having a migraine; Double vision; Ever since the first vaccine she started to see a round shape that don't have any color it's just a blank spot which she looks at night time; started to see spots and blue lines; flu like symptoms; This is a spontaneous report from a contactable reporter reporting on behalf of his wife 54-year-old female consumer (patient). A 54-year-old female patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EWO169), via an unspecified route of administration on arm left on 27Apr2021 (Age at Vaccination: 54 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included ongoing optical migraines, ongoing Dry eyes. Historical vaccines included Flu Vaccine. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations was reported as none. Family Medical History Relevant to Adverse events was reported as none. The patient Concomitant medications were not reported. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0176), via an unspecified route of administration on arm left on 18May2021 (Age at Vaccination: 54 years) at single dose for COVID-19 immunisation. After 1st dose, on an unspecified date, the patient experienced had cold chills for day or two (Reporter seriousness for Chills: Unspecified). On an unspecified date, the patient experienced Blurred vision and Eyes are not working (Reporter seriousness for Blurred vision was unspecified). On an unspecified date, the patient experienced Ever since the first vaccine she started to see a round shape that don't have any color it's just a blank spot which she looks at night time(Reporter seriousness: unspecified) and She looks at a picture or TV, she'll see a big round spot and there is nothing and that's been going on every night the day after the first shot and now it's getting even worse(Reporter seriousness: unspecified). The patient experienced Dry eyes and Double vision (Reporter seriousness: unspecified) on an unknown date. It was reported that Blue lines and just in middle for different stuff she looks at the door, a person, a chair and Anything that she's looking at, she's automatically get a flash off to that but it feels negative picture of it. On an unspecified date, she She felt she is having a migraine. On 07May2021, the patient experienced issues with eyes, started to see spots and blue lines (started to see spots and blue lines was reported as worsened) roughly a week later at night she started to see a round object. If you took a dark ball and put in front of her face you could see it and no shape and It's sometimes it gets bigger and smaller. On an unspecified date, At night, she saw a red circle with nothing in center and could see around it, which moved as her eyes moved. The visual changes started 10 days after 1st shot, and have continued every night since. Right after the first shot a week and a half later she saw circles that didn't go away only at night. On 28Apr2021, the patient experienced flu like symptoms(Reporter seriousness for flu like symptoms: unspecified) for three days. The events required a visit to Emergency Room, they said it sounds like an optical migraine. Wanted to confirm it was not a tumor) and Physician Office(Went to the eye doctor and said nothing wrong with her eye. Nothing wrong but the same symptoms. They saw her optic nerve and nothing was wrong with that) The doctor was also saying she may be having optical migraines. She can't drive or go on the computer due to her symptoms. Has taken his wife to eye doctor 3-4 times, and they say other than dry eyes, there is nothing wrong with eyes or optic nerve. Eye doctor said that she has got several patients that are reporting exact same problems and they just had the vaccination shots like a few weeks prior to them coming in. They (several patients) are having eye blurred vision, fussy vision and the eyes are not just working properly and there is nothing wrong with their eyes like I mean, they (eye doctor) look at them and they don't see anything but yet she (eye doctor) is starting to get reports. Have gone to ER as she was thinking migraines were caused by optical things. MRI done to check for MS, which was negative. MRI "normal.Gave her medicine to alleviate migraines, which didn't help (nausea meds, Tylenol, and a Coke). States these are not her typical migraines. It was reported that Reporter stated, "My wife, her actually started well after the first shot which is 04/27, that's when she had the shot and she started to have the stuff of seeing problems about a week after, which you can put it about May 7th is when it started." (Further not clarified hence not captured in tab). The relevant lab tests included On an unknown date, test: Magnetic resonance imaging, result: normal(Is in her record online. It showed no tumor or aneurysms, or nothing); Test: Multiple sclerosis, result: negative; Test: Ophthalmological examination, result: normal. Therapeutic measures were taken as a result of flu like symptoms included She took Advil, ate, drank and curled up with the heating pad. Therapeutic measures were taken as a result of started to see spots and blue lines, Eyes are not working, Dry eyes, double vision, Ever since the first vaccine she started to see a round shape that don't have any color it's just a blank spot which she looks at night time and treatment included She went to get an eye exam. She went for her eyes a month or so before in February and the doctor wanted to give her eye drops to use. She did the eye exam for one eye and then she went to the the eye doctor in May after the first shot and she started to see spots and blue lines. The doctor looked but there was nothing wrong with her eyes. His wife suffers from dry eyes for over 10 years they have given her different eye drops. They set her up to see a neuro doctor they thought it was something in her head and they had to look at the report. She saw the neuro doctor this past Monday and is seeing lights. In 30 minutes they would get better and for 24 hours a day and 7 days a week she has no migraine. She went to the ER they told her nothing then she went back to the doctor, and they thought it was dipoplia. They asked the eye doctor. They said people in her age get that and in this time of year it could also be MS. She went to her eye doctor and have an eye exam and he looked at everything and said there is nothing wrong with your eyes everything will be fine, she has dry eyes and she found some eye drops to keep them moist but she hasn't had any of these vision problems until after she took the first shot, the second shot things started to get weird on her she started to see a quite double vision, Blurry vision, blue lines and just in middle for different stuff she looks at the door, a person, a chair anything that she's looking at, she's automatically get a flash off to that but it feels negative picture of it and she's seeing this stuff 24 hours a day 7 days a week. I took her to the emergency room because she felt she is having a migraine (Clarification unknown). I took her to the migraine doctor they said there is nothing (incomplete sentence), they did an MRI and said there's no tumor, there is nothing in her head and she had been to that eye doctor three times and each time there is nothing wrong with your eye, there nothing wrong with your optic nerve there something that is causing these vision changes and they are getting worse." The outcome of the events flu like symptoms was recovered, started to see spots and blue lines was not recovered, while other events was unknown. This LRN W2021389225 is cross linked to LRN W2021389226 and W2021389227 Follow-up attempts are needed. Further information is requested.
54 2021-07-17 migraine Thought it was dipoplia; Having issues with eyes, seeing spots; Wifes migraines have been getting wo... Read more
Thought it was dipoplia; Having issues with eyes, seeing spots; Wifes migraines have been getting worse; vision changes/started to see spots and blue lines; optical migraines; She can't drive or go on the computer; dry eyes; started seeing flashes if she looked at anything (began within seconds, would start seeing negative picture form to side of object), then would go away; This is a spontaneous report from a contactable consumer or other non-healthcare professional via Medical Information Team. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0176), via an unspecified route of administration on 18May2021 as dose 2, single for COVID-19 immunisation. Medical history included migraine, dry eye from 2011 to an unknown date. Prior vaccine: flu shot on unspecified date and unspecified month in 2020, for immunization. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution or injection; Expiry Date: unknown, Lot number: EWO169), via an unspecified route of administration on 27Apr2021 administered in left arm as dose 1, single for COVID-19 immunisation and experienced events. She has had migraines since she was 10 or 12 years old. It has been mild in the past. In the last two months to a month it has been more frequent, dry eye from 2011 to an unknown date, from an unknown date and unknown if ongoing. The patient experienced vision changes/started to see spots and blue lines, having issues with eyes, seeing spots on, migraines have been getting worse, optical migraines, she cant drive or go on the computer, dry eyes, started seeing flashes if she looked at anything (began within seconds, would start seeing negative picture form to side of object), then would go away, thought it was dipoplia on Jun2021. Wondered if vision changes are related to vaccine. The doctor was also saying she may be having optical migraines. Has taken his wife to eye doc tor 3-4 times, and they say other than dry eyes, there is nothing wrong with eyes or optic nerve. States these are not her typical migraines. Reports this is happening a lot. When she goes outside without too much visual stimulus, not as bad. Worse indoors. Doesn't behave like her regular migraines, which Excedrin used to help. Flashing spots are getting bigger and not going away. Caller's wife mentioned what she was going through. Eye doctor said he can't get into specifics, but he knows of people that are experiencing blurred visions, fuzzy visions, and eyes not working properly. Said it was temporary, but no time frame given. Caller expresses his frustration with not getting answers from HCPs or anyone else. Caller stated the severity of his wifes symptoms are causing a lot of distress. He states that he feels like they're in a circle where they get no answers, told to go to doc or ER, but they still don't know where this is coming from. She went to get an eye exam. She went for her eyes a month or so before in February and the doctor wanted to give her eye drops to use. She did the eye exam for one eye and then she went to the eye doctor in May after the first shot and she started to see spots and blue lines. The doctor looked but there was nothing wrong with her eyes. His wife suffers from dry eyes for over 10 years they have given her different eye drops. Patient went to Emergency Room to (withheld) they said it sounds like an optical migraine. Wanted to confirm it was not a tumor. Patient Went to the eye doctor and said nothing wrong with her eye. Nothing wrong but the same symptoms. They saw her optic nerve, and nothing was wrong with that. They set her up to see a neuro doctor they thought it was something in her head and they had to look at the report. She saw the neuro doctor this past Monday and is seeing lights. In 30 minutes, they would get better and for 24 hours a day and 7 days a week she has no migraine. She went to the ER, they told her nothing then she went back to the doctor, and they thought it was dipoplia. They asked the eye doctor. They said people in her age get that and in this time of year it could also be MS. After the doctor had said optical migraines. They asked if it could be the Pfizer causing the side effects. They haven't heard of anything and they just don't know. And today she is still having vision problems and it's worse and she is seeing different sites and not seeing with her eyes. She can't stand to get on the computer or drive. Caller stated I took her to the emergency room because she felt she is having a migraine (Clarification unknown). I took her to the migraine doctor they said there is nothing (incomplete sentence), they did an MRI and said there's no tumor, there is nothing in her head and she had been to that eye doctor three times and each time there is nothing wrong with your eye, there nothing wrong with your optic nerve there something that is causing these vision changes and they are getting worse." Reporter further added, "I did not have words to turn because every doctor we go to and we tell them that she had the shot and she's experiencing these problems, they keep telling her we haven't had no side effects that is this, just go have your eyes looked as well, we go to eye doctor he says I have never heard of these side effects, you might need to see neurologist, well we go to neurologist they say we haven't heard of any of these side effects, you might want to check your primary doctor, she goes to primary doctor and they say well we haven't seen any side effects on this, you might want to go and have your eyes checked, so everybody saying to go another doctor and another doctor. She has been round and round twice, and she went to this one family doctor where we live, and she says yes, I have heard of these side effects and I have seen them up here (Further clarification was unknown). We need to find out if possible are they going to be temporary issue and everything should clear up within a few weeks, are they permanent or they going to worse or what. Therapeutic measures were taken as a result of having issues with eyes, seeing spots, migraines have been getting worse, vision changes/started to see spots and blue lines, optical migraines, she can't drive or go on the, dry eyes, started seeing flashes if she looked at anything (began within seconds, would start seeing negative picture form to side of object), then would go away, thought it was dipoplia. The patient underwent lab tests and procedures which included magnetic resonance imaging: normal on 2021 (MRI done to check for MS, which was negative. MRI "normal"), ophthalmological examination: nothing wrong with her eyes on May2021, ophthalmological examination: unknown on 2021 (She did the eye exam for one eye), ophthalmological examination: unknown on 30Jun2021. The outcome of event vision changes/started to see spots and blue lines and event started seeing flashes if she looked at anything (began within seconds, would start seeing negative picture form to side of object), then would go away was not recovered and for rest all event outcome was unknown.
54 2021-07-17 pain in extremity Acute tiredness. Vision deteriorated. Feet hurt for a simple walk.
54 2021-07-17 tingling, numbness lips started tingling and went numb. Within 10 minutes or so, the tingle/numbness travelled to my en... Read more
lips started tingling and went numb. Within 10 minutes or so, the tingle/numbness travelled to my entire face and inside my mouth and tongue.; numbness travelled to inside my mouth and tongue; numbness travelled to my entire face; Tingling travelled to my entire face; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; lot number: EP6955) via unspecified route of administration in the left arm for COVID-19 immunisation on 27Mar2021 at 09:00 (at the age of 54-years-old). Medical history included obesity, osteoarthritis, neuritis and meralgia. Concomitant medications included omeprazole 10 mg (MANUFACTURER UNKNOWN), glucosamine (MANUFACTURER UNKNOWN), pyridoxine hydrochloride, magnesium lactate (MAGNES), and fish; all for unknown indication and from unknown date, unknown if ongoing. The patient previously received KEFLEX and amoxicillin (MANUFACTURER UNKNOWN), nitrofuran class (MACROBID); all on unknown dates for unspecified indications and experienced drug allergy. The patient had no food allergies. The patient did not receive any other vaccine within four weeks, prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. On 27Mar2021 at 09:30, about 25 minutes after the vaccination, the patients lips started tingling and went numb and within 10 minutes the tingle/numbness travelled to entire face and inside mouth and tongue. This side effect randomly happens to the patient 2-3x/year, but she wasn't overly concerned and just watched it. The patient had no idea what triggers it, and stated so it may not be vaccine-related. The patient received self-treatment; popped two BENADRYL after waiting 90 minutes, as a treatment for the events. "Tingle/numb" were gone "1-1:30ish" (around 15 minutes). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events numbness of lips, mouth, tongue, entire face and tingling of lips, mouth, tongue and entire face was recovered on unknown date in Mar2021. No follow-up attempts are needed. No further information is expected
54 2021-07-18 numbness About 30-45 minutes after the vaccine. I had to lay down and I couldn?t move. And my arms went numb.... Read more
About 30-45 minutes after the vaccine. I had to lay down and I couldn?t move. And my arms went numb. Called my husband to come home from work. Almost called 911. I started feeling like I was gonna faint. I had Difficulty breathing and speaking. I was having Short breaths. Severe nausea . Thought I was gonna have Diarrhea but didn?t. Laid down for almost an hour before I finally felt I could move. And started feeling better.
54 2021-07-18 pain in extremity Left arm pain persisted for weeks after vaccine. When I returned for second dose on 1/8/21, I reques... Read more
Left arm pain persisted for weeks after vaccine. When I returned for second dose on 1/8/21, I requested it be administered in my right arm, because left arm was still painful. Two weeks after second dose, I returned to a local gym and begin working out with a trainer. It was apparent that my left arm had decreased ROM at the shoulder. The pain and ROM issues progressed over the next few months and became severe in May. I was finally able to be seen by orthopedic surgeon who diagnosed frozen shoulder on July 7, 2021.
54 2021-07-19 weakness body aches (back, head, shoulders, neck, stiff neck, etc); chills; high fever 103; fatigue/wiped out... Read more
body aches (back, head, shoulders, neck, stiff neck, etc); chills; high fever 103; fatigue/wiped out; no strength; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6207) via an unspecified route of administration in the left arm on 25Mar2021 at 18:30 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer, 10 years prior in 2011. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6201) via an unspecified route of administration in the left arm on 04Mar2021 at 20:30 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26March2021, day after shot, the patient experienced chills, high fever 103, fatigue, no strength, and wiped out. On 27Mar2021, the patient experienced body aches (back, head, shoulders, neck, stiff neck, etc), and fatigue. On 26Mar2021, the body temperature was reported as 103. Therapeutic measures were taken as a result of the event fever and included treatment with TYLENOL, fever broke approximately at 18:00 after taking TYLENOL a few hours earlier on 27Mar2021. The clinical outcome of the events chills, high fever, fatigue, no strength, wiped out, and body aches (back, head, shoulders, neck, stiff neck, etc) was recovered on unknown date in 2021. No follow-up attempts are needed. No further information is expected.
54 2021-07-19 nerve pain I had terrible diarrhea; Symptoms of neuralgia; This is a spontaneous report received from a contact... Read more
I had terrible diarrhea; Symptoms of neuralgia; This is a spontaneous report received from a contactable consumer. A 54-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration in right arm on 08Mar2021 at 04:00 as dose 1 single (at the age of 54-year-old) for COVID-19 immunization. Medical history included Multiple sclerosis, Ileostomy, Blood clot in my arm back in 2014, Crohn's Disease. Concomitant medications included gabapentin 100 mg capsule, valaciclovir hydrochloride (VALTREX) 1 g, 3 times a day, diazepam 2.5 mg tablet, 3 times a day, ondansetron (ZOFRAN MELT), oxycodone 7.5 g, tablet 4 times a day, lansoprazole (PREVACID) 20 mg, once a day, vedolizumab (ENTYVIO) 300 mg for Crohn's disease. It was reported that (after first dose) patient experienced terrible diarrhea and symptoms of the neuralgia and then she was lucky enough to have her Entyvio 300 mg for Crohn's and it helped somewhat diarrhea. Patient received second dose of BNT162b2 on 29 of the March. It was reported that coming out the second dose on 29th immediately was really bad like pain and shortness of breath and she have had a back surgery so and she always feel bad so I did not think anything of it but then she ended up after the second dose into ER and discovered that my Crohn's had caused really bad flare up. Her foot was looking strange but she just was too tired and left ER. She went back to the hospital and couple days later they told me that actually she had deep vein thrombosis now in her legs. She also had superficial clot in that left leg that was the pain began on the edges through eventually the vaccine is basically started and that it's started the Crohn's flare up and now on but I always trying to get back on a shorter time period of Entyvio and she was also on blood thinners now for a blood clot. She have had a blood clot in my arm back in 2014 and also have had it before. So she was kind of fine now because which is she don't know, you know what to do but I just want to make sure it just got reported because I have seen Johnson & Johnson and other getting reports of products. Consumer stated, Because of diarrhea and Crohn's problem she was down to 91 and now in hospital they gave me Prednisone 40 mg, Tablet so the things are coming up. I am just above 100 right now but I have been in the hospital for 5 days now with the clot and Crohn's Flare. Consumer stated, Yes I had Multiple Sclerosis and I have Crohn's disease with ileostomy and I have an ileostomy where I no longer use my large intestine, I just use a bag. So, I just have the small intestine and I have a flare. When probed if still experiencing the events, Consumer stated, Yes she was still experiencing, the arm is much better now. You know that's not really sore. Crohn's is terrible and the blood clot they have me on the Xarelto. She was getting a bit tired and the pain it's pretty bad and Neuralgia is still pretty bad. The diarrhea was getting better so I am just trying to get healthy enough to leave the hospital. So, I can get on Entyvio because her insurance won't allow them to do the Entyvio in the hospital. So it's kind of frustrating but she was also experiencing extreme shortness of breath, extreme fatigue she couldn't get any oxygen to her muscles. She was realizing that was the blood clot. Consumer further stated, She was just wondering had you been hearing any reports of blood clots from the BioNTech Pfizer at all. The patient underwent lab tests and procedures which included endoscopy: nil, sigmoidoscopy: nil, Ultrasound of legs: nil on an unspecified date. The outcome of the event terrible diarrhea was unknown and outcome of the event neuralgia was not recovered. No follow-up attempts are needed. No further information is expected.
54 2021-07-19 pain in extremity after the initial swelling and tenderness at injection site, a few days later, I noticed what looked... Read more
after the initial swelling and tenderness at injection site, a few days later, I noticed what looked like black specks at the injection site; dalys later, the black specks started being replaced with a lack of melanin - (white spots), and soreness in the upper arm and elbow; I reported this to my pcp while at a regular checkup; fast forward to the present day and the lack of melanin has spread to a starburst like effect of 2 inches in diameter and the pain in my arm is still present but in a greater area - in the upper arm, my shoulder and the bend of my elbow.
54 2021-07-20 pain in extremity Leg pain, persistent cough
54 2021-07-21 inability to speak We administered vaccine. Upon patient's observation period it was noticed that patient began having ... Read more
We administered vaccine. Upon patient's observation period it was noticed that patient began having difficulty breathing and could not speak. We administered an EpiPen (0.3 mg) and I called 911. After the EpiPen patient began breathing better but still required EMS assistance. They escorted her off to hospital. I called patient's primary md and spoke with the nurse who stated they were aware she was in the hospital.
54 2021-07-21 weakness Episode of super ventricular tachycardia (SVT) lasting 10-15 minutes with near syncope, pallor, weak... Read more
Episode of super ventricular tachycardia (SVT) lasting 10-15 minutes with near syncope, pallor, weakness which started unexpectedly at rest. The SVT episode was @ 4 weeks after my 2nd COVID19 vaccination. I was able to self regulate after many attempts at Valsalva maneuver. My cardio exercise regimen (typically 5 day/week for 30-40 min) was impacted with limited exercise tolerance for @ 4 weeks after SVT episode.
54 2021-07-21 discomfort On 4/24/21 my ears (especially my left) began to feel "plugged." It impaired my hearing. The feeling... Read more
On 4/24/21 my ears (especially my left) began to feel "plugged." It impaired my hearing. The feeling of it being plugged and the loss of hearing came and went for the first few days. Then it was there all of the time. Decongestants, ibuprofen, and finally I tried Flonase, and sometimes the combination helped the ear to "pop" for short periods of time. I have never had this problem before. (However, about 7 years ago I lost 90% of the hearing in my left ear due to unknown causes. My ENT prescribed prednisone and Flonase ASAP, and thankfully I regained all of my hearing.) About a week after the shot (and lasting for a number of weeks), I felt pressure on my ribs when I sat--it felt as if my bra was too tight and it was painful to sit in certain chairs, and also during a long trip up north to my niece's wedding, which took place two weeks after the shot. On May 22, 2021, 4 weeks after the shot, at 3:20 pm, my heart went into tachycardia for 20 minutes. This has never happened before, and it was terrifying. My husband has atrial fib, so he has an app and a piece of hardware that records the beats and tells whether a heart is in normal sinus rhythm or in atrial fibrillation. The first reading said my heart was in tachycardia--the reading was 123 bpm, with flutters at 155 bpm (there were 2-3 normal beats, and then really fast flutters--I could see my whole chest moving). The next reading was 126 bpm, with flutters 155+ bpm. Over the ensuing weeks, my heart did strange flutters, but they were very short, and I did not have another episode of tachycardia/atrial fibrillation, for which I am grateful. Another strange thing that happened was that two weeks after the shot I got two parallel bruises on the back of my calves. I'd been sitting in a chair, and might have had my calves pressed to a rung, but not hard--I didn't feel pain whatsoever. And yet those bruises were terrible. The "plugged" (feels like inflammation) ears problem has gotten better, although it still returns from time to time (like right now). Overall, I am better now. No more chest pain when sitting, my ears are usually fine, and only a heart flutter now and then?strangely, the ear ?plugged? feeling often happens in tandem with heart flutters. My 24 year old daughter also had several adverse reactions--sharp stabbing pains in her chest, and I'm encouraging her to fill out a form, too--she was terrified over the hours when that kept happening, and so was I. She had other things happen, too, like severe pain when stepping on a ladder?pain in the bottom of her bare foot?and her skin hurt when anything touched it. Her bra strap fell down on her arms, and she ended up with broken blood vessels there. My niece had a horrific rash that spread all over her body--from her armpit (of the arm where she got the shot) all over her body--just in time for her honeymoon. :( I was all for the vaccine, and still am. However, if there is a booster shot, I will not be taking it.
54 2021-07-21 feeling cold 15 minutes after getting the 2nd dose of the vaccine I experienced stiffness in the right side of my... Read more
15 minutes after getting the 2nd dose of the vaccine I experienced stiffness in the right side of my neck and ache in my right ear. this gradually went away and finished out my workday without any additional symptoms. In the early evening about 6pm I was extremely cold and having a difficult time warming up, severe headache, severe body aches, stiffness in my neck. My ears started ringing and thought it would eventually go away. All symptoms continued to the next day except for the chills - I was able to get warm. I was much better by evening and able to go to work the second day after the vaccine but the ringing in my ears never stopped and continues to this day.
54 2021-07-21 feeling hot pt recieved vaccination. after recieving vaccination pt approached counter stating having palpiation... Read more
pt recieved vaccination. after recieving vaccination pt approached counter stating having palpiations and felt warm. we offered to call emergency medical services but patient declined offer. pt stated she will sit down for a little. after 10 minutes pt stated palpiations went away but feeling a little disoriented. she was instructed to wait in store for 30 minutes and recommended that she call for someone to drive her home. she called friend who came to get her and daughter to get her car. she walked out of store by herself to friend/family stating feeling better. before leaving she was instructed that if adverse reactions reoccurs or others arrise to call 911 to seek immediate medical attention.
54 2021-07-21 pain in extremity sore arm for first 24 hours; nausea; low grade fever; This is a spontaneous report from a non-contac... Read more
sore arm for first 24 hours; nausea; low grade fever; This is a spontaneous report from a non-contactable consumer, the patient. A 54-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm right on 31Mar2021 at 10:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date. Concomitant medications of the patient were not reported. Patient previously received diphenhydramine (BENADRYL), oxycodone; acetaminophen (PERCOCET) all from an unknown date for an unspecified indication and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent a COVID-19 virus test, nasal swab on 20Dec2020, result of which was negative. On 03Apr2021 at 16:00 the patient experienced sore arm for first 24 hours, nausea and low-grade fever. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of pain in arm, nausea, low grade fever was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
54 2021-07-24 weakness Severe weakness of my body, brain fog that was affecting my vision and thinking process that had las... Read more
Severe weakness of my body, brain fog that was affecting my vision and thinking process that had lasted about 3-4 hr. My husband and I received the Pfizer vaccine from local center. There were medical persons giving out the Vaccine at the local community center. They said they were from the county public health. We had the vaccine at 1130 am; I am not exactly sure about the time. We excercized about 30 to 40 min and driving home. I started having severe brain fog and weakness of my body. After we made home okay, I had to basically lay down on the couch due to severe weakness and the brain fog. I was thinking about driving myself to nearest ER but was told by my husband to ride it out. The brain fog was affecting my vision and bodily weakness was hindering me from even making to the bathroom.
54 2021-07-25 muscle spasms Started with whole body cramps after the first couple days of receiving second dose. Towards the end... Read more
Started with whole body cramps after the first couple days of receiving second dose. Towards the end of week it move to the legs more so on the right side.
54 2021-07-27 burning sensation I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still hea... Read more
I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; Very horrible reaction burned me from inside out; I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; This is a spontaneous report from a contactable consumer (patient). This 54-year-old non-pregnant female patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0176) via an unspecified route of administration on 27May2021 at 13:00 in right arm (at 54-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medications included estradiol, estriol (Biestrogen), testosterone cypionate and progesterone all were taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0162) via an unspecified route of administration on 28Apr021 at 15:00 in right arm (at 54-year-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient had no known drug allergies (NKDA). It was mentioned that patient received no other vaccine in four weeks, did not have covid prior vaccination and was not tested for covid post vaccination. Six-days later, on 02Jun2021 at 12:00 hours patient broke out in gradual hives on extremities especially hands blistered and shed new skin (still healing after a month) arms, legs, hives then, rash worsening at night and was better upon wakening. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with MEDROL pack and improved but returned as soon as tapered off med, she had very horrible reaction that burned her from inside out (onset: 02Jun2021 12:00 hours). The patient was recovering from all the events. No follow-up attempts were possible. No further information was expected.
54 2021-07-27 facial paralysis Headache, fever, vertigo, ear pain, blisters in mouth, facial paralysis on right side. Symptoms beg... Read more
Headache, fever, vertigo, ear pain, blisters in mouth, facial paralysis on right side. Symptoms began May 18/2021, ER visit 5/23 resulting in diagnosis of Ramsay Hunt Syndrome : shingles (herpes zoster virus) on 7th cranial nerve.
54 2021-07-27 pain in extremity Body aches; Fever; Chills; Sore arm; Diarrhoea; Headache; This is a spontaneous report from a contac... Read more
Body aches; Fever; Chills; Sore arm; Diarrhoea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN), both from an unknown dates for an unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 04Mar2021 at 16:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 11:00 after the second dose of vaccination, the patient experienced fever, chills, body aches, sore arm, diarrhea and headache. The patient did not receive any treatment for the reported events. The clinical outcome of the events of fever, chills, general body pain, pain in arm, diarrhea and headache was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
54 2021-07-27 tingling, cold extremities, pain in extremity, numbness I developed a pain in my right calf and tingliness after 7 1/2 hours after the shot. Woke up next m... Read more
I developed a pain in my right calf and tingliness after 7 1/2 hours after the shot. Woke up next morning very sick as to be expected after already having covid. achey, very tired, headache, runny nose, chills and fever of 101.3, skin is sensative to the touch, nausea diharea, throat is tight, tightness in chest and shortness of breath. at 6:30pm fever goes to 102.3 and my fingers from the 2nd knuckle up turned white, cold and numb which has NEVER happened before. Next morning my fingers and hands are tingling. loose stools for 3 days and exhausted after 6 days.,
54 2021-07-28 feeling hot, pain in extremity She had increase in pain in elbows, wrists and hands after each dose.; She had increase in pain in e... Read more
She had increase in pain in elbows, wrists and hands after each dose.; She had increase in pain in elbows, wrists and hands after each dose.; knee pain and they feel hot; This is a spontaneous report from a contactable Other Health Professional and consumer Specialty Pharmacy. This 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on May2021 (at the age of 54-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing, blood pressure readings went high from Nov2020 to an unknown date (patient reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range). Concomitant medication included tofacitinib citrate (XELJANZ) taken for rheumatoid arthritis from 2019 and ongoing. The patient had she had increase in pain in elbows, wrists and hands after each dose on an unspecified date in May2021 and knee pain and they feel hot on an unspecified date in 2021. Patient reports when she was off XELJANZ for 10 days following each covid vaccine in May2021 and Jun2021. She had increase in pain in elbows, wrists and hands after each dose. patient reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range, her md put her on medication and her readings are now 145/77. No other readings given. Patient states md believes it was from XELJANZ. Patient now states she has bilateral knee pain and they feel hot, she reports she ices them and puts on biofreeze. Registered nurse encouraged to update md. Patient agreed. No further details. The patient underwent lab tests and procedures which included blood pressure measurement: 180 on Nov2020 Patient reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range, her md put her on medication and her readings are now 145/77, blood pressure measurement: 145/77 on 2021 Patient reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range, her md put her on medication and her readings are now 145/77. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021906600
54 2021-07-28 numbness Less than 24 hours extreme reaction. Right side numbness in head, extremely high temperature, couldn... Read more
Less than 24 hours extreme reaction. Right side numbness in head, extremely high temperature, couldn't get out of bed.
54 2021-07-28 pain in extremity Sore Arm & Fatigue on the 2nd day. Pounding heart beat, shortness of breath and high pulse on 6th d... Read more
Sore Arm & Fatigue on the 2nd day. Pounding heart beat, shortness of breath and high pulse on 6th day.
54 2021-07-28 tingling, migraine I was having severe jaw pain on the right side of my face. I started having a tingling feeling in my... Read more
I was having severe jaw pain on the right side of my face. I started having a tingling feeling in my fingers and my toes. I started having memory loss, confusion, migraines and swelling on the right side my face and my eyes was swollen shut. I am also having ringing in the right ear.
54 2021-07-29 pain in extremity tiredness; sore arm for couple of days/arm was a little sore; This is a spontaneous report from a co... Read more
tiredness; sore arm for couple of days/arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 at 17:00 (at the age of 54-years-old) as a dose 1, single for covid-19 immunisation (Want to get back to some kind of life). Medical history included lupus nephritis, hiatus hernia and drug hypersensitivity. Reporter reported that she was diagnosed with Lupus when she was 32 years old, 22-24 years ago, which was Ongoing. Allergic to Lisinopril she had an allergic reaction to Lisinopril that caused her tongue and throat to swell. Reporter reported that she was hospitalized for 3 days and intubated following her allergic reaction to Lisinopril which was Ongoing. she had the allergic reaction to Lisinopril years ago and is unable to provide product details. Reporter reported that she was taking a small dose, she thinks 5 mg, and had been taking it for years when all the sudden she had an allergic reaction. Reporter reported that she was having issues with reflux and went for an endoscopy. Reporter reported that the hiatal hernia was found about a year ago, which was Ongoing. Concomitant medications included mycophenolate mofetil (MYCOPHENOLATE) for Lupus Reporter reported that she began taking Mycophenolate 5-6 years ago. She takes 1000 mg in the morning and 500 mg at night, Which was ongoing. hydroxychloroquine sulfate (HYDROXYCHLOROQUINE ACTAVIS) for Lupus, Reporter reported that she began taking hydroxychloroquine decades ago. Reporter reported that she takes 200 mg in the morning and 200 mg at night, which was ongoing. verapamil (VERAPAMIL) for Kidneys, which was ongoing. losartan (LOSARTAN) Reporter reported that she has been taking Losartan for at least 7 years, for Kidneys , Which was ongoing. pantoprazole (PANTOPRAZOLE) Reporter reported that she began taking Pantoprazole about a year ago, which was ongoing. Sertraline hydrochloride (ZOLOFT ODT), she began taking Zoloft about a year ago, for Problems with menopause which was ongoing. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) was none. AEs following prior vaccinations were A little soreness with flu vaccine. she has previously experienced a little soreness with the flu vaccine. Reporter unable to provide adverse event or product details. Family Medical History Relevant to the event were none. The patient experienced sore arm for couple of days/arm was a little sore on 18Mar2021and tiredness on 19Mar2021. patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 as a DOSE 2, SINGLE for covid-19 immunisation. It was reported that, post 2nd dose of vaccination on 6Apr2021, 5 pm, patient was exhausted, nausea headache, muscle ache and joint ache. On the April 7 pm she had exhaustion and on April 8, 1 diarrhea that was resolved immediately. and then came back again after 2 weeks 26Apr2021, feeling exhausted, nausea, felt having UTI that lasted about 10 days. She reported that she was taking mycophenolate alongside getting the vaccine. She read that taking medications that suppresses the immune system may actually have a lowering response effect alongside getting the vaccine. Given that her daughter is gonna have her wedding, she wanted to know if there is a specific test that can be done to check the efficacy of the vaccine (given she was taking immunosuppressant). Alongside with this, she would like to know if she may wear mask and take pictures on her daughter's wedding (considering that she has a family full of Anti-vaxxers). Reporter reported that she has Lupus, got the second dose of the Pfizer Covid-19 vaccine on 07Apr2021, and is taking immunosuppressant therapy. She has been plagued with a lot of the symptoms that come with the Covid-19 vaccine including headache, nausea, joint pain, and tiredness. Reporter reported that her Lupus has been in remission for a while and that she takes Mycophenolate for Lupus Nephritis. When she had her first dose of the Covid-19 vaccine she was fine. Reporter stated she was just a little tired the next day and her arm was a little sore, nothing major. She received the second dose of the Covid-19 vaccine at 5:00 PM on 06Apr2021. Reporter reported that she made sure that she drank a lot of water that day and didn't pre-medicate before receiving the Covid-19 vaccine. Reporter reported that she felt ok the night of 06Apr2021 and during the day on 07Apr2021. Reporter reported that around 8:00 PM on 07Apr2021, she hit the wall. Reporter reported that she was exhausted, had a massive headache, muscle aches, joint aches, and extreme fatigue. Reporter reported that she drank some more fluids and went to bed. she woke up the next morning on 08Apr2021, had one bout of bad diarrhea, and then all the sudden all of her symptoms were gone. Reporter reported that she then felt fine until 26Apr2021. on 26Apr2021, her symptoms returned. Reporter reported that she felt exhausted tired, nauseous, and weak. Reporter reported that she let it go for 3-4 days then called her rheumatologist to inform them that something is off and she is not feeling good. Reporter reported that she thought that she was having a flare of her Lupus. her rheumatologist ordered a bunch of blood work. Reporter reported that the labs came back showing that her kidney filtration was less than stable and her white blood cells were up a little bit. Her rheumatologist ordered a urine test. Reporter reported that she called her nephrologist who stated that the reporter could have a UTI or kidney infection. Reporter reported that her nephrologist got her started on Cipro until the urine culture came back. The urine culture came back negative, but it was a good 10 days to 2 weeks that she felt lousy. Reporter reported that she finished the Cipro even though she didn't have a UTI. Reporter reported that her nausea, headache, feeling of weakness, and exhaustion then went away. she was just wondering if because she is taking Mycophenolate and it suppresses the immune system that it just took longer for the Covid-19 vaccine to work for her. she is wanting to know what her immunity percentage is or how the Covid-19 vaccine will work since she's taking immunosuppressant medications. she had been doing research and noticed that her medication, Mycophenolate, is listed as having the possibility of causing a lower efficiency rate for the Covid-19 vaccine. Reporter inquired if there is a test that can be done or ordered to check her immunity levels. She read something about stackable protein being checked. Her daughter is getting married at the end of Jul2021 and everything is opening up. Reporter reported that she has a few friends and family members that don't trust science and refuse to get the Covid-19 vaccine. Reporter stated that she is just afraid that being on the Mycophenolate affected the efficacy of the Covid-19 vaccine. she felt a little tired for 10 hours or so on 19Mar2021. her arm was a little sore for a couple of days following the Covid-19 vaccine. all of her doctors strongly recommended that she get the Covid-19 vaccine with her health issues. Reporter reported that her daughter is 27 and the only time the reporter has been off Hydroxychloroquine was 3 months before and while pregnant with her daughter. she takes the blood pressure medications Verapamil and Losartan not because she has high blood pressure but for her kidneys because of the Lupus Nephritis. Reporter reported that she has taken Verapamil since she was switched from Lisinopril. she was having problems with menopause and her gynecologist suggested that sometimes Zoloft can help with hot flashes and things like that. she sometimes takes a multi vitamin, vitamin D, and vitamin C. Her rheumatologist ordered a bunch of blood work. Reporter reported that the labs came back showing that her kidney filtration was less than stable and her white blood cells were up a little bit. she was tested for Covid-19 before going to the gynecologist. Reporter reported that she has been tested for Covid-19 multiple times because of the joint aches, headaches, and muscle aches that her Lupus can cause. The patient underwent lab tests and procedures which included culture urine negative which was negative on an unspecified date, urine analysis 03May2021, culture urine negative which was negative on 07May2021 Negative, sars-cov-2 test that was negative on an unspecified date Negative, urine analysis; white blood cells on an unspecified date, White blood cells - 2, urine analysis white blood cells-over 30 on 07May2021, White blood cells was over 30. Patient had Covid-19 Rapid test on 10May2021 that was Negative. Reporter seriousness for the events were Unspecified. Outcome of the events a little tired was recovered on 19Mar2021 and Arm was a little sore on Mar2021. Information on Lot/Batch number was available. Additional information has been requested.
55 2021-01-03 flushing itching that started @injection site and then spread across body, facial flushing Administered 50 mg... Read more
itching that started @injection site and then spread across body, facial flushing Administered 50 mg of diphenhydramine orally and continued to observe Patient's husband was called and he took her home after approximately 30 mins.
55 2021-01-03 pain in extremity Arm soreness Swelling Overall body feeling shaky
55 2021-01-03 pain in extremity Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radi... Read more
Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radiating towards the back Jan. 01: she noticed a rash in the mid abdomen radiating towards the back. She has been experiencing pain in the affected area.
55 2021-01-04 feeling hot, flushing PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ... Read more
PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ABOUT 4-5 MINS. SHE FELT BETTER AND GOT UP TO WALK ABOUT 30 MINS LATER. SYMPTOMS WORSENED AFTER WALKING ~9:45AM: FAINT AGAIN, SEVERE RETCHING, BP196/140 TO 199/164, TROUBLE SWALLOWING, SOB, WHEEZING. AT 9:58AM, EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED. SYMPTOMS REPORTED IMPROVED FOLLOWING EPI. EMS ARRIVED 10:05AM. PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL. WAS RELEASED BETWEEN 11:30AM-12PM ON 1/4/21, BP 140/90 AND ACUTE SYMPTOMS RESOLVED. FOLLOW UP WITH PATIENT 1/5/21: NO PRIOR HX OF HTN, BP 120/60, NO SOB/ BREATHING DIFFICULTY. C/O SEVERE HEADACHE, LOW TEMP, FATIGUE, MUSCLE ACHES, SORE THROAT.
55 2021-01-04 pain in extremity I STARTED HAVING PAIN IN MY UPPER LEFT LEG AROUND 12/31 ..THE PAIN HAS WORSEN TODAY AND THE PAIN IS ... Read more
I STARTED HAVING PAIN IN MY UPPER LEFT LEG AROUND 12/31 ..THE PAIN HAS WORSEN TODAY AND THE PAIN IS CAUSING ME TO LOSE MY BALANCE. IT FEELS LIKE ITS GOING TO GIVE OUT WHILE WALKING. THE PAIN TRAVELS DOWN MY WHOLE LEG. IF I STAND STILL OR SIT FOR A WHILE ITS HARD FOR ME TO PUT WEIGHT ON MY LEG. I HAVE NEVER HAD PAIN IN MY LEG LIKE THIS BEFORE. I WAS TOLD TO LET VSAFE KNOW DURING MY CHECK IN AND WILL CALL THE NURSE ON DUTY TONIGHT. IT'S BECOMING UNBEARABLE. I AM DUE FOR MY 2ND DOSE ON THE 8TH .
55 2021-01-04 pain in extremity Her arm was very sore; Intermittent stabbing headache; This is a spontaneous report from a non-conta... Read more
Her arm was very sore; Intermittent stabbing headache; This is a spontaneous report from a non-contactable consumer (patient's Sister). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. On 27Dec2020 patient experienced an "intermittent stabbing headache" and her arm was very sore but much better the day of the report. Patient would not take paracetamol (TYLENOL) because she was still very functional. Outcome of the events was unknown. Information about lot/Batch number cannot be obtained. No follow-up attempts are possible. No further information is expected.
55 2021-01-04 tenderness noted swollen lymph node left armpit area, slightly tender
55 2021-01-05 weakness, pain in extremity, muscle spasms On 12/24/20 through Wed 12/30 daily while exercising; either back country skiing, resort/alpine ski... Read more
On 12/24/20 through Wed 12/30 daily while exercising; either back country skiing, resort/alpine skiing, Nordic/skate skiing or hiking uphill, I developed rapid onset, severe, debilitating, crippling 8/10 pain in my right fectus femoris thigh muscle. Duration of spasms 1-2 seconds, frequency every 10-15 minutes while exercising up to 6 hours/day. Self treatment included taking Ibuprofen 400 mg tabs po daily, OTC electrolytes po daily, application of topical diclofenac (Voltaren) gel, increase in hydration of non caffeinated/non alcoholic beverages; without any improvement.
55 2021-01-05 feeling cold Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure wa... Read more
Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure was high on taking 183/91. Patient reports History of "White Coat Hypertension". Symptoms resolved. MOnitored for at least 15 minutes and released to home. Recommended patient follow-up with PCP regarding potential underlying hypertension..
55 2021-01-05 pain in extremity Excruciating pain from left deltoid radiating downward to wrist; Left hip pain/Bilateral knee pain; ... Read more
Excruciating pain from left deltoid radiating downward to wrist; Left hip pain/Bilateral knee pain; Shivering; Headache; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), intramuscular in the left arm, on 28Dec2020 at 16:30 (at the age of 55-years-old) at a single dose for COVID-19 immunization. Medical history included insomnia, gastrooesophageal reflux disease (GERD), anxiety, mitral valve replacement (MVR) on an unspecified date, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks prior to vaccination, included atenolol (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC), sertraline hydrochloride (ZOLOFT), eszopiclone (LUNESTA), krill oil (MANUFACTURER UNKNOWN), linum usitatissimum oil (FLAXSEED OIL; MANUFACTURER UNKNOWN); ascorbic acid (VITAMIN C; MANUFACTURER UNKNOWN), and calcium (MANUFACTURER UNKNOWN). The patient previously took erythromycin (MANUFACTURER UNKNOWN) and experienced allergy, nitrofurantoin (MACRODANTIN) and experienced allergy, and loracarbef (LORABED) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache on 29Dec2020 at 07:00. The events were reported as non-serious. The excruciating pain from left deltoid radiating downward to wrist woke the patient up from her sleep. Therapeutic measures were taken as a result of the events, which included treatment with hydrocodone bitartrate, paracetamol (VICODIN) and heat application. The clinical outcome of excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache was recovered with sequel in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
55 2021-01-06 breast pain INJECTION SITE PAIN, BREAST PAIN
55 2021-01-06 feeling hot Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot ... Read more
Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot and red with raised rash, my scalp became very itchy, my heart felt like it was beating out of my chest and I had pounding in both ears. My bilateral forearms began to itch and then developed hives. I notified my Supervisor that I was having a reaction. I was checked in to ER (where I am an RN). My blood pressure was elevated 180's systolic and my heart rate was 180BPM and short of breath. An IV was started and I was given Normal Saline Bolus, Solu-medrol 125MG and Benadryl 25MG IV. Prior to medications, my throat felt itchy and "tight" but resolved once medication given. The itching and hives continued to spread to my upper back, neck, bilateral feet and behind my bilateral knees. After approximately 1 1/2 hrs itching and hives continued then I was given Pepcid IV and Benadryl 25mg PO which after 40 minutes my itching and hives resolved. I was later discharged home with a prescription of Methylprednisolone 4MG dose pack. Symptoms resolved until approximately 1:30 am on 5/7/2021 when I awoke to pounding in my ears and the feeling once again my heart was beating out of my chest. My heart rate was 132BPM, I became hot and diaphoretic, short of breath. My scalp felt it was on fire and then I broke out in hives. I immediately took Prednisone, benadryl and pepcid. I took a cool shower, got dressed and drove to the hospital down the road and sat in the parking lot just in case my throat became itchy and tight (which it did not). The hives and itching began to resolve after an hour. My heart rate went back to 67BPM and shortness of breath resolved as well. I called Employee Health at hospital and made a report of symptoms.
55 2021-01-06 migraine Migraine sore arm nausea body aches stiff elbows
55 2021-01-06 pain in extremity, weakness Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall ... Read more
Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall weakness Narrative: Employee was unable to work second to symptoms, missing >1 days of work at time of this report.
55 2021-01-06 pain in extremity Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patien... Read more
Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patient managed symptoms with ice packs. Symptoms have resolved as of 1/6/2021
55 2021-01-07 weakness, tingling usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type ... Read more
usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type feeling in wrist
55 2021-01-07 feeling hot Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and ... Read more
Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and had general body aches, which has continued into 1/8/21.
55 2021-01-07 flushing within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl ... Read more
within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl 25 mg , Pepcid , solu-medrol
55 2021-01-07 numbness, tingling Pfizer BioNTech: Complains of left foot numbness and tingling that progressed to left leg and then ... Read more
Pfizer BioNTech: Complains of left foot numbness and tingling that progressed to left leg and then to left hand and left arm. Benedryl PO 25mg given at 12:05pm. No changes after Benadryl given.
55 2021-01-07 migraine VERY sore joint (couldn?t walk using my knees). Very exhausted, migraine headache and slight nausea... Read more
VERY sore joint (couldn?t walk using my knees). Very exhausted, migraine headache and slight nausea.
55 2021-01-07 migraine Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain... Read more
Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain; Headache; Severe muscle pain around the injection site; Severe muscle pain around the injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included diabetes mellitus from an unknown date, covid-19 from an unknown date. Concomitant medication included metformin. The patient stated the side effects were initially day one (30Dec2020) was this general aches, pains and headache. It almost started as if it was a Covid itself starting all over again because she had this disease already earlier this year and the headache and general ache and pains and pretty severe muscle pain around the injection site and also the general aches and pain. The second day (31Dec2020) was extreme fatigue, migraine that the never went away, body aching everywhere including joints and muscle everything. It almost felt like the Covid itself all over again. Patient took Motrin essentially around the clock something 6 (intent: 600mg) to 800 mg every 6 hours or so. The outcome of event migraine was not recovered, the other events was unknown.
55 2021-01-07 muscle twitching Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit o... Read more
Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit of nausea; Ear ringing; Left eye was twitching a lot; At 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on her arm on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included neuropathy in feet and thyroid condition. The patient's concomitant medications were not reported. Patient reported she was having some of the symptoms like the body ache and just the normal and not the really difficult symptoms or whatever just the tiredness, headache, muscle pain and chills, and pain and a little bit of nausea but last night her ears were ringing and her left eye was twitching a lot and she hadn't taken her temperature because she really didn't think she had a temperature. Then she decided to go ahead and take it and at 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101 and the information in the packet doesn't say like if she can take Tylenol or Motrin trying to get this headache to go away. The patient did not receive any treatment for the events. Outcome of the event headache was not recovered, ear ringing was recovering, left eye was twitching a lot was recovered, while the other events was unknown. No follow-up activities are needed. No further information is expected.
55 2021-01-07 night sweats, pain in extremity Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymph... Read more
Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymphadenopathy, fatigue, nausea-evaluation for symptoms- no prescribed treatment
55 2021-01-07 pain in extremity, weakness, night sweats left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection si... Read more
left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.
55 2021-01-07 pain in extremity Recipient reported having chills overnight and reported to work today with left arm to left flank so... Read more
Recipient reported having chills overnight and reported to work today with left arm to left flank soreness. She took Motrin
55 2021-01-07 tingling, flushing Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling,... Read more
Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; hives on neck; This is a spontaneous report from a contactable health care professional nurse, the patient. A 55-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9844), intramuscular in the left arm on 20Dec2020 13:45 as a single dose, Lot number EK5730 for COVID-19 vaccination. Medical history included ongoing complex regional pain syndrome. The patient previously took Ceftiaxone, tizanidine, vancomycin, triamcinone, duloxetine and experienced drug hypersensitivity. Concomitant medication were taken within two weeks but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 14:00 the patient experienced flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes. No treatment was given for the events. The clinical outcome Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating was recovered.
55 2021-01-08 muscle spasms Diarrhea & NauseaVomiting Narrative: jaw pain, metallic taste, cramps
55 2021-01-08 pain in extremity Severe right arm pain initially, about 8 hours post infection. Body aches, profound fatigue, chills ... Read more
Severe right arm pain initially, about 8 hours post infection. Body aches, profound fatigue, chills and dizziness starting 10 hours post injection and persist entire next day.
55 2021-01-08 pain in extremity Myaglia left arm is painful Narrative: Employee reports onset of body aches on 12/29. She denies fe... Read more
Myaglia left arm is painful Narrative: Employee reports onset of body aches on 12/29. She denies fever. Her left arm is also very painful. 12/31 - symptoms resolved.
55 2021-01-10 weakness Tiredness, queasy stomach, low energy, lethargic, headache, swelling and pain at injection site
55 2021-01-10 numbness Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased B... Read more
Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased BP; blood pressure was up and down; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) via an unspecified route of administration in left arm on 29Dec2020 6 am at single dose for covid-19 immunisation. Co-suspected drug amoxicillin;clavulanic acid (AUGMENTIN, Batch/lot number: KN4291, Expiry Date: Mar2022) by mouth from Dec2020 to 28Dec2020 at 875mg, 1 tablet twice daily for pain or infection; MOXIFLOXACIN HYDROCHLORIDE (AVELOX, strength:400mg) by mouth from 29Dec2020 and ongoing at 400mg, 1 tablet once daily for infection; fluconazole (DIFLUCAN, strength:200mg) orally (by mouth) from unknown date and ongoing at 200mg, 1 tablet once daily for Infection.The patient's medical history was reported as ongoing high blood pressure, ongoing pains in her fingers and toes and they thought she had an infection from 02Dec2020, white count went down on 09Dec2020, ongoing pain was up and down. No other vaccines given at that time and none given 4 weeks prior. Had a Flu shot back in Oct2020, but no problems. None diagnosed allergies and family medical history relevant to adverse event. The concomitant medications included unspecified blood pressure medication by mouth daily for high blood pressure. She had also started 2 antibiotics around the same time that she received the vaccine. No further details provided Was on antibiotics at the time she was given the Pfizer COVID-19 vaccine. Patient experienced increased BP/ high blood pressure, pain in head, and leg numbness; all started 2 days (on 31Dec2020) after receiving the vaccine and persisted for 48 hours. First her blood pressure was up and they had to get it stable and had numbness in her head, face, and mouth for 48 hours. Her blood pressure was up and down and she has history of blood pressure and takes medicine. Was taken off work for a few hours and went to the emergency department on Fri night about 2am. Her blood pressure was 170/92 on 01Jan2021. Not sure if this was related to the vaccine, but the numbness in her head started from her upper neck to face to the right side of her check and she also had leg numbness. Wanting to know if this was related because she was worried about getting the second dose. Had a hard time for 48 hours. Weight was between 150-155 pounds. Stated everything improved after 48 hours. Her lip was also just a little bit numb, but it is feeling better. Patient was feeling bad from 01Jan2021, all Fri and Sat and much better by Sun. Events of increased BP/ blood pressure up and down, leg numbness, numbness in lips, head, face, mouth with emergency room visiting. Wanted to know if she should have the second dose. The action taken in response to Augmentin was permanently discontinued on 28Dec2020, for Avelox and Diflucan was dose not changed. The outcome of events was recovering.
55 2021-01-10 numbness pt reported bilateral arm numbness and was diaphoretic at 0904
55 2021-01-10 muscle spasms After both the initial and this second shot, I experienced cramps or tightness in muscles in arm. It... Read more
After both the initial and this second shot, I experienced cramps or tightness in muscles in arm. It was actually more pronounced with first dose. Started in right scapula, then moved to elbow, then to wrist. Symptoms gone after ~30-40 minutes.
55 2021-01-10 pain in extremity localized redness at injection site, R arm/hand joint tenderness and pain, over 72 hr. period
55 2021-01-10 pain in extremity lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure du... Read more
lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure due to mask or injection) started with soreness/heat to site, joint pain, flu-like symptoms- body aches, tired and headaches. - January 9th. most joint pain gone except to fingers gone. soreness and heat to site of injection. - January 10th finger joints hurt still hurts, site of injection - redness swollen/ heat still - around site a "pinching" pain, which is a new today - Jan11th
55 2021-01-10 tingling 1/8/21 tingling/ sensitive/extra warm lips - from 5 mins after injection till 8pm that night 01/08/2... Read more
1/8/21 tingling/ sensitive/extra warm lips - from 5 mins after injection till 8pm that night 01/08/2021 (thought due to wearing mask?) 1/9/21 soreness & heat to injection site - joint pain esp. hands, elbows and wrists; and flu-like symptoms - tired 1/10/21 little redness to site-swollen/soreness & heat still ; joint pain in fingers still not so much in main joints 1/11/21 finger joint pain - lot of redness/soreness/heat/swollen to site of injection ** new symptom sharp pinching pain around site
55 2021-01-11 numbness, tingling Approximately 1 - 2 hours after receiving I had numbess and soreness to my neck. A few days later ... Read more
Approximately 1 - 2 hours after receiving I had numbess and soreness to my neck. A few days later started experiencing tingling, buzzing, weakness and heaviness to my right arm and leg. I reported this to my MS doctor who ordered an MRI of the brain and told me to report to you
55 2021-01-11 pain in extremity began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; began having Covid ... Read more
began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; Arm was sore; This is a spontaneous report from a contactable physician reported for herself. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 vaccination. Medical history was not reported. There were no concomitant medications. Patient had arm sore on 18Dec2020. She started having COVID symptoms on 24Dec2020. She tested positive on Christmas, 25Dec2020. She was asking if she should get the second vaccine. When she got the vaccine she didn't pay attention to the paperwork. She was busy. Her arm was a little sore for a day that was the only reaction she had. She was hoping when she developed COVID symptoms that she was not sick. She was not hospitalized, and she is wondering if maybe the vaccine helped her not get as sick, and not end up in the hospital. It was the first dose she received. She has no other medical conditions. All the previous agent did was read off information to her. It sounds to her like she should go ahead and get the second dose. Outcome of event Arm was sore was recovered in 19Dec2020, of others was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be completely excluded for reported events.
55 2021-01-12 weakness After getting out of the bathtub as I was reaching for my towel, A VERY SUDDEN ONSET of severe weake... Read more
After getting out of the bathtub as I was reaching for my towel, A VERY SUDDEN ONSET of severe weakeness hit me and I had to sit on toilet. I was unable to move my arms or legs for 20 minutes, then was able to get up but walked VERY WOBBLY AND WEAK to my bed just a few feet away. I collapsed on my bed and turned my fan blowing on me directly. {Im NEVER hot, usually cold ALL the time}. I layed there so weak I could barely move for another 20 to 30 minutes. I thought I was having a stroke honestly and my thoughts were about my doors being locked so nobody could get in to help me and my phone was in the living room and for that time period I WAS TOTALLY UNABLE to go get it. THANKFULLY, after about 45 minutes total, all symptons went away and I returned to my baseline mobility. Im very grateful that this was not a stroke as I thought. but I do believe it may have been a reaction to the vaccine. I did not notify any physicians yet, and as of this writing Im perfectly fine, Thank the Lord.
55 2021-01-12 hot flush ITCHY NOSE , BELTCHING, HOT FLADHES, TOUNGUE HAVINESS, TREATED WITH EPI AND BENADRLY
55 2021-01-12 numbness, tingling to develop a rash yesterday. It started off as large red spots last night, and this morning they are... Read more
to develop a rash yesterday. It started off as large red spots last night, and this morning they are smaller red spots. She said the rash started in her feet and is moving upwards. This morning it is now on her arms. She also said she was having numbness and tingling from the waist down as well. Last night she did take Benadryl. She is not experiencing any other side effects. She did not have this reaction after the first dose. prednisone, benadryl given at urgent care, prescription for prednisone given at Urgent Care
55 2021-01-12 numbness Tuesday, 1/12/21 around 8:00 am I noticed a Numbness, similar to when novocaine is wearing off. Loca... Read more
Tuesday, 1/12/21 around 8:00 am I noticed a Numbness, similar to when novocaine is wearing off. Location of numbness is in the area of the Right temple upper cheek bone easing toward ear. By 2:00 pm that day was experiencing a dull headache centering on my temple. I went home from work to lie down. The headache and numbness lasted into the next day. At the time of this report 8:57 pm on 1/13/21 the numbness is still there.
55 2021-01-12 migraine migraine with mild vomiting resolved by morning with medications
55 2021-01-12 pain in extremity, flushing, breast pain, tremor 12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck.... Read more
12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck. 12/24/20 @ 0600 vomited x 2. Headache, runny nose, fatigue, general achiness---became worse as the day progress to include both hips and knees becoming painful. Shortness of breath with pulse ox levels of 91-97% on room air. Heart rate 104-124 bpm for 9 hours, Chest discomfort, cough, achy fingers, mild hand tremors, flushed face, nausea, decreased appetite, fatigue, chills . 12/25/20 @ 0120--severe muscle and joint pain---self medicated with 1000mg acetaminophen, stomach pain---used digestzen. tossed and turned until after 0428. 0920--increased area of painful lymph nodes: left arm axilla, breast and back of neck. Fatigue continues---although less than the day before 12/26/20 through 12/28/20 symptoms continue to decrease. 12/29/20----woke up feeling great. Took the stairs at work---no shortness of breath. At work received the mail out Covid test-----results were positive ( no symptoms of covid)
55 2021-01-12 pain in extremity Chills Very sore arm
55 2021-01-12 tingling, numbness The day after I received my 2nd Pfizer COVID vaccine (Day 1), I experienced sore muscle at the injec... Read more
The day after I received my 2nd Pfizer COVID vaccine (Day 1), I experienced sore muscle at the injection site and I noticed that the skin in my left flank, left back and Left abdomen felt numb. On Day 2 1/12/21, the numbness got progressively worse and it was noted that there was a marked difference while showering, my upper left hip and thigh were also beginning to get numb. I went into the ED where they took x-rays, gave me steroids (Decadron) and sent me home for follow up within the next 3-5 days. Today, Day 3-1/13/21,My skin still feels numb and less, and the tingling in my left thigh is no longer present. dx"paresthesia," no other concerns as it has not affected my movement or ability to work.
55 2021-01-13 burning sensation Burning, itching, painful rash over back, stomach and groin. Rash and swelling in hands and ankles
55 2021-01-13 feeling hot During the early morning following my second Covid vaccination, I started having fever and chills, m... Read more
During the early morning following my second Covid vaccination, I started having fever and chills, muscle aches, and a headache. I woke up about 230 am and my stomach was hurting. I thought I would have to have a bm in a little while but was able to go back to sleep. About an hour and a half later, I again woke up with stomach pain, maybe some bloating. I decided to go into the bathroom and I sat on the floor beside the toilet and began vomiting. I vomited 5 times and had one dry heave. The vomitus was clear in color, thin with some small pieces of food. I had felt very hot before vomiting, but was unable to check my temperature due tp nausea and vomiting. I checked my temperature a little while later and it was 100.2 F. I was able to go back to sleep for a while and kept checking temperature during the day. It was between 99.1 and 99.8 for most of the day.
55 2021-01-13 pain in extremity I had the vaccine on 1/11 at 11:30AM. I only had a sore right arm on Tuesday. I noticed a full fron... Read more
I had the vaccine on 1/11 at 11:30AM. I only had a sore right arm on Tuesday. I noticed a full front and back body rash that afternoon. It started spreading up my neck and onto my forehead. No other symptoms. I took 25mg of Benadryl that evening. Woke up the next day with improving rash but still visible.
55 2021-01-13 pain in extremity Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; mu... Read more
Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; muscle and joint aches; arm pain; arm pain and swelling; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 06Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history included mild hypertension and arthritis. The patient was not pregnant. No Covid prior vaccination, no Covid tested post vaccination. No known allergies. Concomitant medication included estradiol, norethisterone acetate (COMBIPATCH), meloxicam, propanol. The patient previously received 1st dose of BNT162B2 in left arm on 17Dec2020 15:45 for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced egg sized lymphadenopathy under right arm 36 hours after 2D injection (08Jan2021 03:00), after flu symptoms of muscle and joint aches, arm pain and swelling at 20 hours (07Jan2021 12:00). No treatment received for the events. The outcome of events was not recovered. This case was reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of lymphadenopathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
55 2021-01-13 pain in extremity Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, requi... Read more
Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, required 10mg prednisone for 3 days to stop itching. Lasted 4 days. Also Left arm pain, 4 days. Fatigue and subjective fever.
55 2021-01-13 tingling, flushing, feeling hot, burning sensation I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a d... Read more
I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a drink. My throat then felt a bit warm and I thought this was due to thirst as well. I left the monitoring area. I was walking to my vehicle and began to feel more of a warm sensation in my throat and not into my upper chest. About 5 minutes after this took place my face became flush and began tingling and feeling sunburned and tight - I looked in the mirror and my cheeks and nose and chin were red and felt extremely warm - I did not have facial swelling that i noticed buy my face felt tingly and like it was sunburned - my eye felt puffy but did not look puffy enough to notice in the mirror. Approximately 30-35 minutes after the immunization, I took 50mg of Benadryl and 1300mg of Tylenol. I felt my symptoms begin to improve about 25-30 minutes after taking the medication - my throat and chest were not as warm. the facial flushing lasted about an hour or hour and a half. The morning after my immunization I did have a scratchy throat - I did not take any further medication - by the afternoon - this is almost gone - still just a little scratchy.
55 2021-01-13 tingling Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Mediu... Read more
Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Medium, Systemic: Headache-Mild, Systemic: upper body test rash, itchiness around eyes and mouth, she discribed a tingling sension in the back of her throat, verbilized her tongue was swelling; symptoms lasted 1 day
55 2021-01-13 tremor Awakened severe shortness of breath, chills, muscle shakiness and pain, nausea, vomiting
55 2021-01-14 inability to speak, tingling Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am ... Read more
Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am 1/14, lasted until appx 12noon. On 1/15, appx 8am I awoke with nausea. Began to vomit and all my extremities began to tingle. At that point, my hands and feet became rigid. This spread throughout entire body, including my head. I was unable to move my hands or feet. My fingers were frozen so hard that my husband could not even close my hand for me. My tongue felt thick and I was having difficulty speaking. Husband picked me up off the floor and carried me to our bed. We were getting ready to call 911 when my feet began to wake up and the rigidity subsided for all areas. Epidsode lasted appx 15 mins.
55 2021-01-14 burning sensation Developed shingles on left side of spine on mid/lower back area. 1.5 inch x .5 inch. I have a histor... Read more
Developed shingles on left side of spine on mid/lower back area. 1.5 inch x .5 inch. I have a history of shingles in 2011. I received the 2 dose shingles vaccine in 2019. I received my second Pfizer dose on 1/11. Developed fatigue and muscle aches on 1/12, then slight headache, muscle weakness, myalgia's and arthralgia on 11/13. Morning of 11/14, woke up and noticed a sore spot/blister on my lower/mid back area. Slowly became more painful (burning sensation). No injury to area or any other reason for blister and pain. 11/15, realized it was shingles.
55 2021-01-14 cold sweat Within 1 and 1/2 hours headache, nausea, diarrhea, cold sweats. Lasted for about another hour and 1... Read more
Within 1 and 1/2 hours headache, nausea, diarrhea, cold sweats. Lasted for about another hour and 1/2. Now feel weak. All other symptoms are gone.
55 2021-01-14 pain in extremity Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, r... Read more
Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, rash on right arm. Lymph nodes sore on neck on Day 2.
55 2021-01-14 tingling About 20 minutes after vaccination, felt tingling throughout body. Slight headache, followed by fee... Read more
About 20 minutes after vaccination, felt tingling throughout body. Slight headache, followed by feeling dizzy and wobbly. Must hold onto something to walk. Has some trouble focusing, "like a fog".
55 2021-01-14 cold extremities Started to have horrible body aches and chills about 10 hours after shot. Felt very febrile with fro... Read more
Started to have horrible body aches and chills about 10 hours after shot. Felt very febrile with frozen finger tips. Could not warm them up. Continued fatigue and febrile and malaise.
55 2021-01-15 weakness, unresponsive to stimuli Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At ... Read more
Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At around 2:30pm that day was complaining of chills and generalized malaise. Then at ~9:30pm when husband returned home from work found patient diaphoretic, confused (stating things like "not now, I want to go to lake"), and complaining of chills and weakness. Unable to provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to respond to verbal commands. Initial vitals notable for T102.6F (unclear other vitals). Patient is now AOx0 most concerning for encephalopathy.
55 2021-01-15 numbness The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feelin... Read more
The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feeling shaky and short of breath- afternoon of injection Significant headache x 48 hours (note: still having intermittent HA associated with 1st dose.) Significant arm pain (injection site)- 2 days Feeling shaky in legs- evening of injection Low grade fever x 48 hours, ongoing intermittently Waking at night several times- this does not happen to me. Waking overnight last night (AM of 1/16/21) with right hand numbness that lasted for some time. Extreme, extreme fatigue- the worst lasted 48 hours post vaccination. Still continuing but not as severe as the first 48 hours. Body aches, particularly (but not only) right hip and knee that have arthritis- worst sx ~ 36 hours post vaccination. Ongoing intermittently. Heart palpitations but unable to determine if related to vaccination. Chest pain, mid-left sternal, intermittent, ongoing. More of a muscular pain/discomfort. Note: for 1st injection had some similar "side effects" but also some that were different.
55 2021-01-15 migraine Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatig... Read more
Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatigue, pain a swelling a injection site.
55 2021-01-16 tingling I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for se... Read more
I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for several minutes. My lips, tongue, lower jaw and teeth started to feel tingly and strange. This started to get better in about 30 minutes but didn't completely resolve for about 3 hours.
55 2021-01-17 burning sensation, tingling, numbness, weakness Day if injection Severe HA- that has not really let up 1 week later Facial numbness of injection sid... Read more
Day if injection Severe HA- that has not really let up 1 week later Facial numbness of injection side that spread to top of head, and down to chest and right arm- sensation of face being scaled on right side Day 2- Brain Fog, Generalized Weakness, Generalized pain Right ear remains numb Day 3 1/13- felt like my entire body received a tetanus vaccine Day 4 unchanged Day5- woke up in head to toe hives- was sent to ED Have been having intermittent rashes ( like dermatitis) pop up all over my body and random numbness typically on head/ neck Continue with headache on day 7
55 2021-01-17 feeling cold, weakness I had the vaccine on 12/20 and I started feeling cold couple of hours after the vaccine and chills o... Read more
I had the vaccine on 12/20 and I started feeling cold couple of hours after the vaccine and chills on 12/21/20. Mild body aches and soreness at site of injection and just feeling weird. This continued off and on 12/22, 12, 23 and etc. I thought it wasn?t a big deal as I had no respiratory symptoms and no fever. However, I just haven?t been well since then. I have ongoing nausea, head fog, severe weakness, very tired and just feeling unwell
55 2021-01-17 feeling cold 12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle ac... Read more
12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle aches, dizziness, headache, disorientation. 20 hours after injection: swelling of lips. Continued body aches, headache, 32 hours after injection: chest pain, continued body aches, headache, swelling of lips.
55 2021-01-17 pain in extremity woke up the next day feeling nauseous, by 12 noon I had a fever 100.4 feeling very tired malaise and... Read more
woke up the next day feeling nauseous, by 12 noon I had a fever 100.4 feeling very tired malaise and headache. This feeling lasted for 24 hours. By Friday afternoon I was feeling better and by Saturday no reactions. Arm was sore for 24 hours
55 2021-01-18 weakness Fever , joint pain, headache, weakness, nausea since 5 pm last night.
55 2021-01-18 weakness I received the vaccine and approx 1min I developed chest pressure, head pressure, Dizzy + lightheade... Read more
I received the vaccine and approx 1min I developed chest pressure, head pressure, Dizzy + lightheaded - Had a hard time waking to gurney due to dizzy. BP +180s Back burning pain traveling mid back to lower back, joint pain, general weakness, throat scratchy, itichess on legs + Think I was monitored for 2 1/2 hrs and sent home after Benadry + Tylenol given. I have continued to have extreme fatigue. general weakness, lightheaded, dizzy and burning back pain lasted 11 days. Today is 12th day and still have lightheaded, dizzy intermittent and general weakness, fatigue, "no energy."
55 2021-01-18 flushing Flush. SOB. Extremely nauseous. Rapid onset of fatigue
55 2021-01-18 pain in extremity This is a 55 year old female who presents with a history of right shoulder, upper arm and upper back... Read more
This is a 55 year old female who presents with a history of right shoulder, upper arm and upper back pain (mainly centering on the upper right scapula) that started on Saturday, Jan 16th. States that onset was sudden and limited her range of motion; when she turns her neck towards the left, the pain is exacerbated. She denies arm or hand weakness or sensory dysfunction (i.e. no tingling or numbness of the fingers). She does not note any fever or erythema of the shoulder. She has been treating with ibuprofen, which she states she has seen improvement of the pain. Two weeks ago, she received a COVID-19 vaccine in the right arm, although from the picture she took the vaccine appeared to be administered higher than the deltoid. Suspect this could represents shoulder injury related to vaccine injury. Other than synthroid she takes no other medications on a routine basis. She stated that she developed an iatrogenic hepatitis after taking either rifampin or INH, and was told not to take those medications; however, she reports no history of anaphylaxis to a drug or vaccine.
55 2021-01-18 pain in extremity Reported sharp pain to the left arm, heart palpitations. Symptoms resolved. Will follow up with PCP.
55 2021-01-18 tingling Tingling of body, chills, fatigue
55 2021-01-18 tingling Anxious, tingling, heart racing, throat closing. Pt was given 25 mg IM. Pt started feeling within 15... Read more
Anxious, tingling, heart racing, throat closing. Pt was given 25 mg IM. Pt started feeling within 15 mins. PT vitals returned to normal within 10 mins. Pt discharged home with friend.
55 2021-01-19 numbness, tingling I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observ... Read more
I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observation area. After release I went to my car and started to drive home. At the 25 minute mark post vaccine (1:55pm) I felt numbness and tingling of cheeks and lips (no swelling and no difficulty breathing). I drove the nearby adult hospital, parked on a side street to wait and see if anything got worse. After 10 minutes symptoms subsided and I continued home. At the 50 minute mark post vaccine (2:20) I felt numbness and tingling of my right arm which subsided after 10 minutes. No further side effects.
55 2021-01-19 numbness Transient numbness and tingling of left cheek lasting 7 minutes. No allergic signs or symptoms.
55 2021-01-20 facial pain, numbness, tingling After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after va... Read more
After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after vaccination and intermittently x 5 days after the vaccine. Following day had tingling to the right side of my upper lip and right side of face felt somewhat numb. Had pain to right side of face up to right ear.
55 2021-01-20 feeling cold About 13 hours after vaccine, fever to 100.4 F, shivering, chills, muscle aches, headache, nausea, f... Read more
About 13 hours after vaccine, fever to 100.4 F, shivering, chills, muscle aches, headache, nausea, fatigue, slight abdominal cramping. Throughout the day, fever continued despite Aleve and aspirin, but muscle aches began to subside with aspirin. Abdominal cramps lasted about an hour, and nausea went away after chicken soup and sleep. 24 hours after vaccine, fever coming down to 99.2F, muscle aches diminished, no nausea or fatigue, or abdominal cramping. The next morning, only a slight headache remained, no other symptoms.
55 2021-01-20 feeling hot felt warm from head to toe. Instantly gone.
55 2021-01-20 numbness I was walking to cross a street and both legs went numb and I fell.
55 2021-01-20 pain in extremity sore arm; This is a spontaneous report from a contactable Other HCP. A 55-year-old female patient re... Read more
sore arm; This is a spontaneous report from a contactable Other HCP. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EH9899, Intramuscular on 21Dec2020 06:00 at single dose on left arm for COVID-19 immunization. Medical history was none. The patient had no Allergies to medications, food, or other products. Concomitant medication included atorvastatin. The patient had sore arm after the fist dose of BNT162B2 on unknown date. No treatment was received for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was resolved.
55 2021-01-20 pain in extremity Went to dentist thinking i had a toothache on Monday from the pain. it was very painful was on m... Read more
Went to dentist thinking i had a toothache on Monday from the pain. it was very painful was on my whole left side of face did xray was referred to oral surgeon did exam and both confirmed it had to be a reaction to vaccine. was prescribed Flexural and Toradol Aleve. medication takes about an half hour to kick. been in bed for a week with ice on my face. Cant work at all.
55 2021-01-20 pain in extremity pt currently has muscle pain at the injection site, chills, and has pain on upper left leg in betwee... Read more
pt currently has muscle pain at the injection site, chills, and has pain on upper left leg in between knee and groin area. Pt had 101.2 fever the night after the injection but it subsided by morning.
55 2021-01-20 tingling, pain in extremity, numbness, facial paralysis HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONG... Read more
HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONGUE, TEETH, JAW, NECK WENT NUMB, I CAN FEEL IT NUMB AROUND MY LEFT EYE TO. ITS LIKE BELLS PALSY WHEN I TRY TO SMILE LEFT SIDE OF LIPS GO DOWN ANSLEFT SIDE OF LIPS ARE NUMB AND THELEFT SIDE OF FACE IS SWALLEN AND JAW IS TIGHT.CHEEK FEELS THICK, TINGALING IN ARM DOWN LEFT ARE TO PINKY FINGER. SORE ARM WHERE SHOT IS. TIGHTNESS IN SHOULDER. CALLED NURSE SAID TO WATCH IT STILL THE SAME AFTER ALL NIGIHT, STILL NUMB ANS SWALLEN BUT CAN EAT BREATH AND TALK.
55 2021-01-21 weakness Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspot... Read more
Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspots: @ 12hrs temp 102.6 F: @ 15hrs Oxygen desaturation 89-90%, weakness, extreme fatigue Seen at ED aprox 6PM on 1/9/21: CBC, chem panel, CT abd, CXR Continued to have low sats and was admitted to hospital on 1/10/21 adverse reaction to vaccine, Reactive airway, asthma excerbation discharged on 1/12/21
55 2021-01-21 tremor High fever 102 started at 2:30AM on the 7th . I had riggers, my whole body was out of control shakin... Read more
High fever 102 started at 2:30AM on the 7th . I had riggers, my whole body was out of control shaking like a seizure. I was extremely confused I had a 8/10 headache. I had serve fatigue. This last about 24 hours then went away I finally got out of bed the next day about 4:30PM.
55 2021-01-23 weakness Headaches,joints pain, weakness, temperature over 100
55 2021-01-24 weakness Extremely week, extreme muscle pain, temp over 100 degrees farenheit
55 2021-01-24 burning sensation The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Th... Read more
The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Thinking it was hives, I applied cortisone cream and took Zyrtec. This continued through following week. I went to my personal physician and was diagnosed with shingles though I never had any outward rash or blisters. Just skin sensitivity . I was prescribed triamcinolone acetonide cream 0.5% which I have been applying twice daily. I have not had an outbreak but have had minimal internal pain that feels like strained or pulled muscle in the same area.
55 2021-01-24 feeling hot, flushing Was sitting for observation, around 5 minutes later starting coughing and getting flushed in the fac... Read more
Was sitting for observation, around 5 minutes later starting coughing and getting flushed in the face and saying it was getting hot. Then, continued to cough and was using her prescribed inhaler ( unknown what type of inhaler it was ). Administered epi-pen immediately, and called 9-1-1. Had to administer second epi-pen 5 minutes later, and patient also took two 25 mg benadryls. A nurse at the facility was the one to administer her epi-pens. They were the patient's prescribed epi-pens
55 2021-01-24 pain in extremity On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. S... Read more
On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. Sever shivers, sweating, whole body aches, lethargic, nausea, loss of appetite, low grade fever, developed golf tennis ball size lump right axilla.
55 2021-01-25 feeling of body temperature change Body aches, hot and cold.
55 2021-01-25 numbness Right arm numbness; Right arm numbness and discomfort when raising at shoulder level and above; This... Read more
Right arm numbness; Right arm numbness and discomfort when raising at shoulder level and above; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), intramuscularly on 07Jan2021 08:15 at right arm, at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included omeprazole, potassium gluconate; oenothera biennis oil (EVENING PRIMROSE); ascorbic acid (VIT C); glucosamine; ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient previously took clarithromycin (MACROBID) and known allergies was Macrobid. The patient was not pregnant at the time of vaccination. The patient experienced right arm numbness and discomfort when raising at shoulder level and above on 12Jan2021. No treatment was received. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
55 2021-01-25 numbness Right sided lips and facial numbness half hour post vaccination. Benadryl 25mg IVP Pepcid 20mg IVP S... Read more
Right sided lips and facial numbness half hour post vaccination. Benadryl 25mg IVP Pepcid 20mg IVP SOLU-Medrol 125mg IVPB
55 2021-01-25 pain in extremity I couldn?t lift my arm above shoulder height or laterally without extreme pain for the first few day... Read more
I couldn?t lift my arm above shoulder height or laterally without extreme pain for the first few days. The pain lessened for a day or two and then came back, but not as severe. It is uncomfortable to lift it even after applying heat and taking Extra strength Tylenol and Ibuprofen. It is keeping me awake at night and limiting movement in the upper right shoulder/bicep area.
55 2021-01-25 pain in extremity DEVELOPED RIGHT ARM AND SHOULDER PAIN WITH DIFFICULTY RAISING ARM. PAI 7 OUT 10 ON PAIN SCALE
55 2021-01-25 tenderness, feeling cold Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; ... Read more
Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Cold, chills, and felt like freezing to death; Cold, chills, and felt like freezing to death; Felt like drunk driving; Cold, chills, and felt like freezing to death; Severe headache; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 07Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. The patient experienced cold, chills, and felt like freezing to death, felt like drunk driving, severe headache and dizziness on 07Jan2021; swollen glands, neck, face, and ear on left side on 12Jan2021; tender on an unspecified date. The patient received COVID-19 Vaccine on 07Jan2021 at approximately 11:45. She felt like drunk driving: She waited the 15 minutes and was fine. Afterwards, she got into her truck and was literally weaving. Had to really concentrate to keep the truck in a straight line. She had severe headache: Did not go into work on Friday because headache was so bad. It was almost a migraine. She could still feel it, but it was not as severe. Patient known it's five days out, but yesterday (12Jan2021) she got up and glands on left side of neck were swollen. That side of her face and ear was swollen. It was very pronounced. She still swollen today (13Jan2021). Patient stated she worked with dementia and didn't know if she should go into work when she was still swollen and tender. The patient took Benadryl (Lot: P119936, Exp: Apr2023) as Equate Allergy Relief at 25mg, two capsules at night for the reaction. The patient had been taking it every night since she received the COVID-19 Vaccine. Headache was still there. This morning woke up with swollen glands, neck, ear, and face on the left side. The outcome of events "cold, chills, and felt like freezing to death" and dizziness was recovered on 10Jan2021; of event "Felt like drunk driving" was recovered on an unspecified date; of event severe headache was recovering; of event "Swollen glands, neck, face, and ear on left side" was not recovered; of event Tender was unknown. Information on Lot/Batch number has been requested.
55 2021-01-25 tremor, weakness When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. aroun... Read more
When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. around 5 o'clock I started feeling ill and then i started about quarter to 6 I started getting cold and shaking bad but it wasn't like a seizure. So really severe chills. When i got home i got under heated blanket then I started getting itchy and noticed hives all over body. then I started getting blisters on palms of my hands and they were like water blisters. I was uncontrollably itchy. I started looking up online what to do and asked friends and family and started taking Benadryl. I had to take it for 4-4.5 days so then the hives finally went away but I was still itchy. I've just been very very exhausted and been having to push myself to get up. I had anxiety about getting the vaccine but I decided to get it. I still don't feel like myself, I don't have much of an appetite but not losing weight because I've been forcing myself to eat. I'm taking vitamins and praying I feel better but I just don't feel like myself. I don't have as much energy and exhaustion is the big thing. My joints started hurting really bad.
55 2021-01-26 burning sensation, pain in extremity mild metallic taste; poor administration tech; extreme burning for 10 min following vax-I; arm soren... Read more
mild metallic taste; poor administration tech; extreme burning for 10 min following vax-I; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Workplace clinic. Medical history included obesity from an unknown date. Known allergies included sulfa and penicillin. Concomitant medication included metoprolol, vitamin d3, calcium, probiotics. Patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild metallic taste on 22Dec2020 11:30 with outcome of recovered, arm soreness on 21Dec2020 with outcome of recovered, poor administration tech on 21Dec2020 11:40 with outcome of recovered, extreme burning for 10 min following vax-i on 21Dec2020 11:40 with outcome of recovered. The verbatim as follow: 1st Vax: mild metallic taste and arm soreness (including extreme burning for 10 min following vax-I believe this was poor administration tech), slight metallic taste 24 hrs post vax, lasted a few hours. Patient didn't receive treatment for the adverse events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Jan2021. The covid test type post vaccination was Nasal Swab. The covid test name post vaccination was PCR.
55 2021-01-26 pain in extremity, electric shock sensation 1/26/21 at 6:30 am patient woke up and noticed that her left fifth digit felt like an electric shock... Read more
1/26/21 at 6:30 am patient woke up and noticed that her left fifth digit felt like an electric shock pain when making a fist. Pt. states that she took tylenol for the pain and did not get relief. Pt. states that her left fifth digit is still painful 8-9/10. Pt. states that she is currently working now, and she is trying to be cautious of her left fifth digit pain so that she does not trigger the pain.
55 2021-01-26 pain in extremity Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoul... Read more
Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoulders; fever of 99.6/low grade; Sore arm; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included urinary tract infection (UTI) from 06Jan2021 and ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), in the left upper arm with no issues. At first, she just had a sore arm on 08Jan2021. Then this morning, on 13Jan2021, she was having chills, enlarged lymph nodes, body aches in her back and shoulders, and a fever of 99.6. It is low grade but does not take much. She has been checking her temperature every 4 hours and it is not any different. She was taking paracetamol (TYLENOL) for a few days to ward anything off. Today (13Jan2021), she laid off the paracetamol to see if she really did have a fever. She did not want to mask it. So, she is taking paracetamol for that off and on. She talked to one person who said the symptoms should last 1-2 days. Then another person said they could last up to a week. She hopes that it is related to the vaccine. She will be mad if she gets COVID after doing all of this. Outcome of the sore arm was recovered on 09Jan2021 and of the remaining events was not recovered.
55 2021-01-26 pain in extremity had a sudden headache come on about 1 hour after shot, but it went away within about 1 more hour...w... Read more
had a sudden headache come on about 1 hour after shot, but it went away within about 1 more hour...woke up at 5:00 this morning (day after shot) with horrible pain from shoulder all the way to finger tips....fell back asleep, woke again at 7:30 with the same symptoms got up and tried moving the arm (with pain) went ahead and used arm and read reactions and what to do...tried to use arm, after about 1 hour of trying to use arm the pain is just over the injection where there is a grapefruit size hard spot with intense pain. Will continue to try to move the arm and use cold compresses and drink water as the organization site suggested. Pain is not just in upper arm with majority of pain in that grapefruit size area.
55 2021-01-26 tingling About 20 min after injection patient re-presented to clinic with complaint of R armpit tingling sens... Read more
About 20 min after injection patient re-presented to clinic with complaint of R armpit tingling sensation, as if it were 'asleep'. Sensation not relieved by anything, not worsened by anything. Patient said it was more a nuisance than anything. Advised by clinic staff that might be nerve issue related to the injection itself. She said she would not want to go to the ER but would follow up with her primary care doctor if issue persisted.
55 2021-01-27 flushing Pt. received shot at 1:47pm. Patient began feeling light headiness and flushed at 1:50-1:55pm and p... Read more
Pt. received shot at 1:47pm. Patient began feeling light headiness and flushed at 1:50-1:55pm and put head down between legs and tried to control breathing. At 2pm pt was given 50mg of Benadryl and BP was 120/40, pulse 102. Patient was then sitting upright with legs elevated and began sipping orange juice and water. Cold ice packs and/or wash cloths were applied to back of neck. At 2:12 patient feeling flushed again and put head back down between legs. EMS was contacted. At 2:17 pulse was 151/60. Pulse 74. Patient then was laid down with legs elevated. At 2:25 BP was 173/102. At 2:30 EMS arrived and then transported pt to ER.
55 2021-01-27 pain in extremity Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontane... Read more
Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 12Jan2021 at 16:00 at a single dose in the clinic for COVID-19 immunization. The patient received the first dose on 22Dec2020 at 16:00 on the left arm for COVID-19 immunization. The patient's medical history was not reported. Patient is not pregnant at the time of vaccination and did not have COVID prior to vaccination. Concomitant medication included ibuprofen and tramadol. The patient experienced very painful lymphnode in arm of injection, pain radiating down arm into fingers on 13Jan2021 at 17:00. Outcome of the events was not recovered. Information of lot/batch number has been requested.
55 2021-01-27 tremor uncontrollable shaking; fever up to 103; This is a spontaneous report from a contactable Other HCP (... Read more
uncontrollable shaking; fever up to 103; This is a spontaneous report from a contactable Other HCP (patient). This 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284) intramuscularly on 11Jan2021 06:00 at SINGLE DOSE on left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included atorvastatin. The patient previously received first dose of BNT162B2 (lot number EH9899) intramuscularly on 21Dec2020 06:00 AM at SINGLE DOSE on left arm for covid-19 immunisation, and experienced sore arm. The patient experienced uncontrollable shaking, fever up to 103 on 12Jan2021. No treatment received for the adverse event. The outcome was recovered. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
55 2021-01-28 discomfort, migraine, weakness Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighi... Read more
Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighing me down. I also had a migraine, nausea, joint discomfort mostly in my shoulders hips, lower back and base of head. I slept most of the day into the next day and felt better approximately 46-48 hours after the vaccine administration. Slight headache continued and swollen lymph nodes in the armpit noticed day 2 and continue to this day. Alternated Tylenol 1000mg PO w/ Advil 400ng PO.
55 2021-01-28 flushing Vaccine was administered at 9:20 AM by public health at the Community Center; patient was observed f... Read more
Vaccine was administered at 9:20 AM by public health at the Community Center; patient was observed for 30 minutes without problems; patient reports she left after 30 minutes of observation and was on her way home when she started to feel itchy and scratched under her chin; around 10:15 AM she had more itching and redness to her skin and was flushed in her cheeks so she took a dose of over the counter Benadryl. by mouth; she continued to have itching throughout the day and reports she took another dose of Benadryl at 4:00 p.m. and again at around 2:00 a.m..
55 2021-01-28 numbness, tingling, hot flush Pt was waiting her 15 minutes post vaccine administration when pt began to feel hot & flushed, have ... Read more
Pt was waiting her 15 minutes post vaccine administration when pt began to feel hot & flushed, have difficulty swallowing ( constant need to clear throat), dry mouth, numbness & tingling in feet & legs. 2mL of dexamethasone 4mg/mL given IM to left deltoid by FNP. Epinephrine 0.3mg/0.3mL given IM to right upper thigh by FNP. Pt placed on 2LPM O2 via NC for comfort. Pt tolerated well. Pt recovered & left our clinic at 1635.
55 2021-01-28 pain in extremity, weakness Soreness in left arm, fever, severe headache, nausea, weakness.
55 2021-01-28 pain in extremity Little Mild Asthma when I exhale, have feeling I need to cough. when I breathe deep get sharp pain ... Read more
Little Mild Asthma when I exhale, have feeling I need to cough. when I breathe deep get sharp pain in back. Arm sore for a day.
55 2021-01-29 flushing Felt flushed and tired by 8pm that night of injection,Jan 12. Woke the next morning with worst heada... Read more
Felt flushed and tired by 8pm that night of injection,Jan 12. Woke the next morning with worst headache I've ever had, in addition to horrible neck stiffness. Slept most of the day. Felt awful. 28 hours after vaccine started vomiting. Vomited for almost 24 hours. Had stomach pain the night of the 15th. Had a low grade temp the next day 16th and on the 17th my heart rate was elevated as high as the 150's. The whole time I was tired. I was Covid tested the 14th because symptoms were so severe but it was negative. I was abnormally tired but finally felt normal by January 19th.
55 2021-01-31 weakness, numbness, tingling The patient received the vaccine at 8:30 am. Reported no issues with first vaccine. The patient rep... Read more
The patient received the vaccine at 8:30 am. Reported no issues with first vaccine. The patient reported driving and feeling lightheaded and heart started racing. The patient pulled over sat and walked around and felt better. Then got back in the car and kept driving, heart was racing again, couldn't move fingers, blood was pounding, fingers appeared white and numb. The patient called 911 and volunteer firefighter came, ambulance arrived and could move fingers again. Blood pressure was 136/104. For 10-15 minutes fingers felt numb and tingly, light headedness, and heart racing all stopped. The patient drove home and was not taken to the hospital and felt weak and shaky for about an hour.
55 2021-01-31 weakness, pain in extremity, tremor After approx. 10hours of receiving the vaccine in my left arm-shoulder at work , I was sleeping and ... Read more
After approx. 10hours of receiving the vaccine in my left arm-shoulder at work , I was sleeping and was awakened With: SEVERE CHILLS - teeth chattered in my head & legs shook -uncontrollably for over 9 hours FEVER- 103 Degrees -on & off for 8 hours BURNING - STINGING - in both hands and turned red 1-2 days LEFT ARM - sore- swollen 1 week [LEFT ARM - still has aches and stiffness] HEADACHE- -top of head for 2 days JOINT PAIN -all over for 3-4 days WEAKNESS- for over 72 hours
55 2021-01-31 weakness Severe Dizziness; nausea; body pain; It felt heavy and temporary unable to raise; Severe chills (fel... Read more
Severe Dizziness; nausea; body pain; It felt heavy and temporary unable to raise; Severe chills (felt like all my internal organs are frozen cold); heartbeat sounded strong beats (can feel the pump); Body weakness; muscle weakness; It felt heavy and temporary unable to raise; This is a spontaneous report from a contactable consumer reported for herself. This 55-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 14Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced severe dizziness (BP normal at 120/80), nausea, body pain, while sideways lying down: unable to raise right foot or raise her foot. It felt heavy and temporary unable to raise for two days, severe chills (felt like all my internal organs are frozen cold), heartbeat sounded strong beats (can feel the pump) for at least 2 days, body weakness or muscle weakness.Start date for all events were 14Jan2021. Meclizine 25mg was received as treatment. The patient had no Covid tested post vaccination. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no known allergies. The patient had all normal from blood glucose of 109 and bp 120/80 on 14Jan2021, day of vaccine was a perfect day. Outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.
55 2021-01-31 feeling hot Hot rash(almost like a sunburn) on my body. Mainly chest and arms., neck, shoulders. A little on bac... Read more
Hot rash(almost like a sunburn) on my body. Mainly chest and arms., neck, shoulders. A little on back stomach and legs. Started sat jan 30 and is still present. Also had bodyaches, headache and chills. Those are gone now.
55 2021-01-31 migraine Migraine headache with floaters
55 2021-02-01 feeling cold tired so slept; chills (freezing); chills (freezing); aches; fever 100 degree F; This is a spontaneo... Read more
tired so slept; chills (freezing); chills (freezing); aches; fever 100 degree F; This is a spontaneous report from a contactable healthcare professional (HCP [patient]). A 55-year-old female patient received second single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL1284, exp date not reported), via an unspecified route of administration (vaccine location: Left arm) on 12Jan2021 07:30 for Covid-19 immunisation. Facility type vaccine: Hospital. Patient previously took first single dose of BNT162B2 (Pfizer, lot number: EJ1685) on 22Dec2020 06:15 (at 54-years-old), vaccine location: Left arm for Covid-19 immunisation. Facility type vaccine: Hospital. The patient was not pregnant. The patient had no known allergies. Patient had no other relevant history. There was no other vaccine given within four weeks. There were no concomitant medications. The patient did not have Covid prior vaccination. On 12Jan2021 22:00, also reported as 12 hours post second dose injection, the patient experienced chills (freezing), aches, and fever at 100 degrees F. The patient took paracetamol (TYLENOL). On 13Jan2021, also reported as in the middle of 1st night, she had 101.1 degrees F. On the same date, in the morning, the chills were gone, and fever was down to 99.9 F. On the second day (14Jan2021), she still had aches with temperature at 99.9 F and was tired, so she slept. The patient took paracetamol again. On the third day (15Jan2021) she had slight aches and no fever. On the Fourth day (16Jan2021) she was normal. No other treatment was received for the events. The patient was not Covid tested post vaccination. The patient recovered from chills on 13Jan2021, fever recovered on 15Jan2021, while the other events recovered on 16Jan2021.
55 2021-02-01 feeling hot The first 15 minutes I got hot. 15 minutes after that which would be 30 min I started itching. I wor... Read more
The first 15 minutes I got hot. 15 minutes after that which would be 30 min I started itching. I worked my 12 hour shit. I woke up 300am and my body was hurting so bad, it felt like something was laying on my chest, shoulder arms and legs. I crawled out of the bed and took a Tylenol and that helped a little bit. at 600 am I took another 650 mg Tylenol. And my body has been hurting so bad and I've been itching. I took a bath yesterday about 6:00 and my body is on fire like I'm itching real bad. I don't think I should have took a bath, because that might have made the blood circulate more and my body aches like crazy, worse than before. The last time I took a Tylenol was 6:00.
55 2021-02-01 pain in extremity headache/back of head, body aches, pain in right arm from elbow to shoulder and into neck, stiff nec... Read more
headache/back of head, body aches, pain in right arm from elbow to shoulder and into neck, stiff neck, fever 101, nausea
55 2021-02-01 pain in extremity Severe headache, mild arm pain, extreme fatigue, and brain fog. The headache subsided with advil aft... Read more
Severe headache, mild arm pain, extreme fatigue, and brain fog. The headache subsided with advil after 12 hours. Arm pain was 2 days, brain fog lasted around 65 hours, fatigue lasted 3 days.
55 2021-02-01 tremor, burning sensation Shaking , burning in arm, leg chest face, rapid heart rate
55 2021-02-02 feeling hot Systemic: Headache-Mild, Systemic: Other- Patient stated that she was feeling hot from her feet to h... Read more
Systemic: Headache-Mild, Systemic: Other- Patient stated that she was feeling hot from her feet to her head with sluggishness and headache 4/10 on pain scale.-Medium
55 2021-02-02 feeling jittery Received vaccine on 1/25/2021. Awoke on 1/27/2021 nauseated and took 1/2 promethazine 25mg tab, at 1... Read more
Received vaccine on 1/25/2021. Awoke on 1/27/2021 nauseated and took 1/2 promethazine 25mg tab, at 1630 that afternoon symptoms included vomiting, headache, aching and fever. These symptoms continued for 3 days. On third day patient started having diarrhea and feeling very "jittery". Took Excedrin for aches and headache. Pt did not seek medical treatment.
55 2021-02-02 migraine, weakness, hot flush 36 hours after receiving the 1st dose of Pfizer vaccine I experienced extreme dizziness in the morni... Read more
36 hours after receiving the 1st dose of Pfizer vaccine I experienced extreme dizziness in the morning, nauseous, chills, hot flashes, racing heartbeat and was very weak. Had some lapses in thought process. I did not have a fever. These symptoms persisted for 5 days. On 2-2-21 I started to get a migraine, so took a prescription medication (Sumatriptan Succinate Tablet 50 mg) and this helped with the nauseousness. My symptoms seem to decrease around 3pm in the afternoon, but never completely go away. Each morning, the cycle repeats with dizziness, nauseousness and chills and some thought lapses. It's been one week since my first dose of the vaccine, and these symptoms are lessening but are still prevalent.
55 2021-02-02 tenderness, pain in extremity Received 2nd vaccine on 1/14/21 on 1/15/21 was sick with flu like symptoms and pain in both legs for... Read more
Received 2nd vaccine on 1/14/21 on 1/15/21 was sick with flu like symptoms and pain in both legs for 5 days was seen by doctor who did covid test came back negative. After 5 days flu like symptoms some what resolved but leg pain continued. Hard to walk and painful. Seen doctors 2 more times when they finally did bloodwork and sent her for admission to hospital. They have done Bloodwork, MRI's and they are all coming back normal but still have leg pain, cant bend toes or touch leg. Been out of work since.
55 2021-02-03 difficulty speaking, feeling hot Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Pati... Read more
Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Patient states she is not anxious. She then started feeling like her throat and chest were getting itchy. Continued monitoring and she felt she needed to be evaluated in ER. Taken to ER. ED notes as follows: 55 y.o. female who arrived by to the emergency department for Throat and chest discomfort associated with voice change and pruritic rash. Past medical history of food and environmental allergies, Addison's disease, thyroid disease, primary immune deficiency disorder. Half an hour ago, the patient received her first injection the Covid vaccine. Seconds later, the patient started having a pruriti rash where the site of the injection was. She then noticed her chest getting red and warm. About 15 minutes later, the patient noticed her voice becoming hoarse her and associated with throat and chest discomfort. Reports that she is unable to take a deep breath. Denies any noisy breathing, nausea, vomiting, abdominal pain, shortness of breath, difficulty swallowing, drooling. She has never been hospitalized for anaphylaxis. She denies any past medical history of asthma or COPD Vital signs demonstrate hypertension with systolic blood pressures into the 180-190s. No oropharyngeal swelling. Hoarse voice. Scleral injection present bilaterally. Chest wall nontender. Mild, blanching, erythematous, pruritic rash on anterior chest. Shallow breathing when asked to take a deep breath. Injection site covered with bandaid with no other obvious rashes or swelling patient arrived to the ED in no acute distress and in stable condition. She was complaining of throat discomfort with voice changes. She has never had an anaphylaxis reaction before. She was given benadryl, famotidine, and methylprednisolone initially for her reaction. With her hypertension and reported chest discomfort, epinephrine was not given initially. Her symptoms mildly improved with the initial treatment. Patient complained of chest discomfort and EKG showing T wave inverted in leads V4-5. She was given aspirin. Initial troponin negative and repeat was ordered. After four hours of observation, the patient reports her voice change has resolved but continued to have pruritis in different, migrating areas of the body such as ears, neck, and arms. 1330: patient complaining of increasing chest and abdominal pain. Described as a cramping chest pain that radiated to her abdominal. Denies nausea, vomiting or diaphoresis. Continues to deny shortness of breath. Given morphine for her pain and aspirin for her nonspecific EKG changes. Internal Medicine consulted for admission due to allergic reaction. Patient is agreeable to this plan. Patient was transferred under stable condition to the IM service. Initial Vital Signs [02/03/21 1159] Blood Pressure 168/101 Heart Rate 73 Respiratory Rate 15 Temp 36.8 °C (98.3 °F) Temp src Oral SpO2 96 % Following one day admission she was discharged to home with Zio patch monitoring while on new beta-blocker therapy for symptomatic PVCs with plan for PCP follow-up. Regarding adverse drug reaction, she was advised to follow-up with PCP and immunologist for further discussion on benefits:risk of subsequent vaccine in series.
55 2021-02-03 feeling cold Massive headache; Severe chills; Couldn't get warm all day even with multiple layers of clothing; Di... Read more
Massive headache; Severe chills; Couldn't get warm all day even with multiple layers of clothing; Dizziness/lightheaded; Feverish; Going from freezing cold to sweating profusely; Right arm is really itchy; Place on right arm started out as a red blotch the size of a nickel, but today is as big around as a grapefruit; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 16Jan2021 (17:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 30Dec2020 (when the patient was 55 years old) on the left arm for COVID-19 immunization. The patient had no issues with the first dose of vaccination. On 17Jan2021, the morning after the second dose of vaccination, the patient woke up with a massive headache; developed severe chills; could not get warm all day long even with multiple layers of clothing; was dizzy and lightheaded; feverish; was freezing cold one minute, and then sweating profusely the next; right arm was really itchy; and had red blotch that was as big as a nickel, then as big around as a grapefruit at the time of reporting. The outcome of the events was recovered on 19Jan2021 for 'massive headache', 'could not get warm all day long even with multiple layers of clothing' and 'dizziness/lightheaded'; was recovering for 'severe chills', 'feverish' and 'freezing cold one minute, and then sweating profusely the next'; was not recovered for 'right arm was really itchy' and 'red blotch that was as big as a nickel, then as big around as a grapefruit'.
55 2021-02-03 flushing Symptoms: c/o flushing, chills. Vitals stable. Intervention: rest, reassurance, used bathroom ? felt... Read more
Symptoms: c/o flushing, chills. Vitals stable. Intervention: rest, reassurance, used bathroom ? felt better.
55 2021-02-03 muscle spasms Patient received Pfizer #1 on 1/6/21 and developed muscle cramps and tinnitus and was evaluated by E... Read more
Patient received Pfizer #1 on 1/6/21 and developed muscle cramps and tinnitus and was evaluated by ENT, TMJ specialist,allergist and her PCP. Hearing test revealed mild hearing loss in high frequency. 1/27/21 received the second dose of the vaccine. The following day she developed flu-like symptoms, including fever, chills, headache and fatigue and worsening of Tinnitus. Received Dupixent two weeks prior to the vaccine.
55 2021-02-03 tremor, feeling cold Severe headache not responding to well to either Tylenol or ibuprofen, severe uncontrollable shaking... Read more
Severe headache not responding to well to either Tylenol or ibuprofen, severe uncontrollable shaking chills, oral temperature up to 102 F. Severe body aches, especially lower back, severe fatigue
55 2021-02-04 weakness, discomfort Later that night after the vaccination I woke up hot, my body was achy all over, I had a headache an... Read more
Later that night after the vaccination I woke up hot, my body was achy all over, I had a headache and begin to cough. I took another dose of cough meds but it didnt work. That next morning I visited my PCP and my temp was 98.7 when I arrived but the temp elevated to 99.9 while there and another temp was taken shortly after and was 100.8 so I was advised to go back home. Once home I was so tired and weak I could barely make it to the couch. My temp then was 101 so I laid down. The couch was so bad it caused my throat to begin to hurt. I lost my taste and sense smell, my body ached so bad it was unbareable and I developed various bruises all over my body still while continue to cough presistantly. I was off work for about 3 days and those 3 days were the worse days of my life, I was so unconfortable and scared it was almost unbareable I thought I was going to die. And on Thursday the symptoms begin to diminish and by that night it was if nothing had ever happened.
55 2021-02-04 cold sweat, numbness, flushing Tongue tingling /numbness Diaphoresis Clammy skin Lightheaded Facial flushing
55 2021-02-04 feeling of body temperature change, feeling hot Felt crummy; Felt funny and started to get hot and chills at the same time; Felt funny and started t... Read more
Felt crummy; Felt funny and started to get hot and chills at the same time; Felt funny and started to get hot and chills at the same time; Tired; Had increase temperature; Hot and flushed and bright red in face; Hot and flushed and bright red in face; immunocompromised; Slept 14 hours; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3248), intramuscularly in right arm on 15Jan2021 14:27 at single dose for covid-19 immunisation. Medical history included Lupus may make her immunocompromised which diagnosed in 2011, Raynaud's, hypertension which was completely managed, irritable bowel and reflux. All were diagnosed prior to the vaccine. Family medical history was none. There were no additional vaccines administered on same date of the Pfizer suspect. Concomitant medication included hydroxychloroquine for Lupus for many years, tadalafil (CIALIS) took for years for secondary reynauds associated with lupus, amlodipine from Jan2019 for blood pressure abnormal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient only had the first vaccine and at the time she received it, she got hot and flushed and went bright red in the face. That lasted 2 hours. She was literally bright red on her face. She got it Friday at 2:27 pm on 15Jan2021. Friday night, she slept 14 hours, which was unusual. She only got out of bed to walk her dogs. Saturday (16Jan2021), she felt funny and she started to get hot and chills at the same time. She took her temperature and temperature started in mid 99 degrees Fahrenheit and popped up to 100 degrees Fahrenheit. Then same thing again Saturday night. She slept 14 hours, which was unusual. Sunday (17Jan2021), she felt crummy. Her temperature spikes to 100.3 on Sunday. She contacted her manager who advised her to contact Employee Health the next morning and employee health told her that if her temperature spiked again on Monday to get a COVID test. She said it never went above 99 degrees Fahrenheit. Today (21Jan2021) was the first day she did not feel crummy. The sleepiness improved but only because she had to go to work. She was still tired. Feeling funny lasted 2-3 days. Her temperature on Saturday (16Jan2021) was 100 degrees Fahrenheit and on Sunday (17Jan2021) was 100.3 degrees Fahrenheit. She never took her temperature on 15Jan2021. The temperature had improved, but it was still hanging out around 99.4 and 99.6. Feeling crummy persisted through yesterday (20Jan2021). Today (21Jan2021) was the first day she felt normal again. She felt crappy all week. She took a fair amount of medication and did not know if it was relevant or not. She had other medications and had been on them for a long time. No ER or physician's office required. She contacted with employee health but had not seen a provider. She planned to discuss with her provider because she wanted recommendation if she should receive vaccine 2. She realized it was a judgment call because she was only 50% covered after having the first dose. She was not sure if she will have a worse reaction with the second. Most people she talked to have no reaction but a significant reaction to the second one. She did not have any information on any of those that had a significant reaction. Details and time of onset provided as: Hot and flushed and bright red in face 14:28, Slept 14 hours 21:00-23:00, tired - she felt it the day before and said it started at 10:00 on Saturday morning, Felt funny and started to get hot and chills at the same time: 12:00, had increase temperature shortly after 12:00, because that was when she checked her temperature, felt crummy 10:00. The outcome of event hot and flushed and bright red in face, felt funny and started to get hot and chills at the same time, felt crummy was recovering. The outcome of event slept 14 hours, tired, increase temperature was not recovered.
55 2021-02-04 hot flush ?Pfizer-BioNTech COVID-19 Vaccine EUA" (1st Dose) Muscle aches, severe head ache, hot flashes, rash... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA" (1st Dose) Muscle aches, severe head ache, hot flashes, rash and hives on scalp, back, stomach, arms, legs, face. Treated with topical prescription cream and allergy pills, ibuprophen
55 2021-02-04 tingling Patient received her Covid vaccine at 15:28 and at 15:50 started having prickly feelin gin her hands... Read more
Patient received her Covid vaccine at 15:28 and at 15:50 started having prickly feelin gin her hands, legs and lips. EMS assessed and treated with Diphenhydramine 25mg orally. She had no change in her symptoms so was sent by personal vehicle with a driver to local ER up the street. Report called and given to ER @16:05
55 2021-02-04 tingling nausea; body aches; headache; fatigue; tingling in both hands (and fingers); crushing depression; Th... Read more
nausea; body aches; headache; fatigue; tingling in both hands (and fingers); crushing depression; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the left arm on 19Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included osteoarthritis, restless legs syndrome, rubber sensitivity (latex allergies), and COVID-19. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included ropinirole. On 19Jan2021 14:15, the patient experienced nausea, body aches, headache, fatigue, tingling in both hands (and fingers) and crushing depression. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
55 2021-02-05 numbness Headache, lightheaded, dizziness, bilat foot and arm numbness, chest pain, SOB
55 2021-02-05 pain in extremity Arm pain radiating to forearm, muscle pain in armpit area, swollen lymph armpit area left side of br... Read more
Arm pain radiating to forearm, muscle pain in armpit area, swollen lymph armpit area left side of breast
55 2021-02-06 pain in extremity, tingling, weakness, muscle spasms Chills, Fever, muscle pain, spasm, headache, stuffiness, dizziness, weakness, nausea, cramps, fatigu... Read more
Chills, Fever, muscle pain, spasm, headache, stuffiness, dizziness, weakness, nausea, cramps, fatigue, heaviness in legs, needle sticking sensation on hands and feet, sore left arm (limited mobility)
55 2021-02-06 tingling Tingling in finger. Just one. Left hand
55 2021-02-07 weakness PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, C... Read more
PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, COUGH, SOB, CHILLS, SWEATS, FEVER OF 103 DEGREES, RHINORRHEA, CHEST PAIN, FATIGUE, TIREDNESS, WEAKNESS, SUDDEN LOSS OF SENSE OF TASTE,, SUDDEN LOSS OF SENSE OF SMELL.
55 2021-02-07 discomfort, pain in extremity symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrib... Read more
symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrible diarrhea; constant headache; Gas; Bloating; Her arm was sore for 24 hours; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL8982, unknown expiration), via injection once to right arm on 14Jan2021 at a single dose as she is eligible with first tier for vaccination. Medical history and concomitant medications reported as none. The patient reported that she received the first dose of COVID vaccine on 14Jan2021 (Thursday). The next day (15Jan2021), her arm was sore for 24 hours after the shot, and she didn't have any side effects over the weekend. On 19Jan2021, Tuesday, she started having constant headache, and was experiencing problems with gas and bloating, it is very rare for her to have this issue, and it was building the last of couple days, she was uncomfortable and was taking over the counter medication for relief. She was keeping the headaches at bay with generic ibuprofen (lot: S200378, expiry: Mar2023), but if she missed a dose or is feeling better and doesn't take, it is coming back, it is consistent. Gas and bloating are primarily after eating, on Wednesday, after 24 hours it was ridiculous. She got some generic Extra Strength Gas Relief one tablet after eating (lot: 75257, expiry: Jun2022), and it was giving her some relief until early this morning. Tuesday, Wednesday, and Thursday, the gas and bloating was worse. Last night, her entire chest, she wanted to burp so bad, but couldn't because it really hurt, and it took a while for the next tablet to kick in and give relief, she was like where is this coming from, she didn't know it could build up so much. On 22Jan2021, she had a terrible diarrhea. Diarrhea was painful and intense, she took generic Pepto Bismol 1-2 tablets, and she took 4, The first time she woke up at 04:30 AM and at 7 another wave hit her, so she took another two tablets. Right now, she is feeling okay, but the gas is building up, her chest is filling, she is uncomfortable. The patient asked if these are reported side effects. She works in a dental office, and the doctor is knowledgeable and sensitive to COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, are these side effects or may she have COVID, though she doesn't know who she could have gotten COVID from. Out of protection for patients at dental clinic, the HCP at clinic wants her to get the COVID test as he believes it could be COVID and not side effect of the vaccine. She doesn't want to quarantine for nothing if it is just side effects of the vaccine. She will be getting rapid diagnostic for COVID and not the antibody test. She thinks she should get tested, but there is no testing appointment available until tomorrow, and she does not want to self-quarantine needlessly, she will live through it, she is happy to get the test, but she doesn't want to lose 2 weeks of pay if others are reporting the same side effects. She was happy to get the vaccine. The patient recovered from the event arm sore on 16Jan2021; not yet recovered from events constant headache, gas, and bloating; while unknown outcome for the remaining events.
55 2021-02-07 feeling hot nauseous/sick to my stomach; Weird headache; slight ache in my hip; Slight dizziness; fogginess/didn... Read more
nauseous/sick to my stomach; Weird headache; slight ache in my hip; Slight dizziness; fogginess/didn't feel right; I got hot/got very over heated; This is a spontaneous report from a contactable other hcp (patient). A 55-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL3246), intramuscular at left arm, on 20Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included possibly ibs occasionally from an unknown date. The patient's concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No Known allergies. Approximately 20 hours after, on 21Jan2021 14:15, slight dizziness/ fogginess, she got hot, just didn't feel right lasted about 5 minutes. Around 1030 am on 22Jan. She got very nauseous, sick to her stomach, dizziness/ fogginess again, got very over heated. Weird headache. No fever, slight ache in her hip. After about 10 minutes it passed and she feels fine. No treatment AE. No COVID tested post vaccination. The outcome of the events slight dizziness/ fogginess, she got hot, just didn't feel right on 21Jan2021 14:15 were recovered on 21Jan2021 14:20 (reported as lasted about 5 minutes), of events nauseous, sick to her stomach, dizziness/ fogginess again, got very over heated, Weird headache, slight ache in her hip on 22Jan2021 10:30 were recovered on 22Jan2021 10:40 (reported as passes after about 10 minutes).
55 2021-02-07 flushing, tingling Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127... Read more
Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127/90 (usually 90/60); Had difficulty swallowing; Fingers started tingling; Chills (lasted 15-20 minutes); This is a spontaneous report from a contactable consumer. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. On 15Jan2021, after 2 minutes of the vaccine, patient heart rate went from normal (53-60) to 100 bpm; the patient felt flushing feeling and blood pressure went up to 127/90 (usually 90/60); patient had difficulty swallowing and fingers started tingling, followed by chills (lasted 15-20 minutes, as reported). The patient was ok 90 minutes after the shot. No treatment given. The final outcome of all the events was recovered in Jan2021.Information on the batch/lot number has been requested.
55 2021-02-07 night sweats Night chills/sweating; HR of 130/HR was 120; soreness and bumps to anus; soreness and bumps to anus;... Read more
Night chills/sweating; HR of 130/HR was 120; soreness and bumps to anus; soreness and bumps to anus; Bodyaches; fever; chills/Night chills; nausea; headache/mild headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 07Jan2021 at a SINGLE DOSE for COVID-19 immunization. Medical history included palpitations. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 on 18Dec2020 at 17:00 via intramuscular route of administration in the left arm for COVID-19 immunization. Concomitant medication included atenolol, vitamin b complex, colecalciferol (VITAMIN D), vitamins (MV), esomeprazole magnesium (NEXIUM), omeprazole (PROTON) and fish oil. The patient previously took morphine and experienced allergies. On 08Jan2021, 1 day post-vaccination after the second dose of vaccine, the patient experienced body aches, fever, chills, nausea, headache and muscle weakness. Then on 18Jan2021, she had night chills and sweating, HR (heart rate) of 130, and mild headache. She also noticed soreness and bumps to anus on 18Jan2021. On 19Jan2021, patient still had chills, HR was 120 and continue to feel muscle weakness Took 100mg atenolol to decrease HR. Usually prn 25 mg atenolol. The soreness and bump increase and was growing. Patient will consult with cardiologist regarding HR. The outcome of events body aches, fever, nausea, headache and was recovered on 13Jan2021. The outcome of event chills, muscle weakness, soreness and bumps to anus was not recovered. The outcome of the other events was unknown. Patient did not receive any treatment for the events body aches, fever, nausea, headache and muscle weakness. Whereas therapeutic measure was taken as a result of "HR of 130/HR was 120". No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
55 2021-02-07 pain in extremity nipple drainage; itchy and watery eyes; itchy and watery eyes; sore arm; metallic taste; This is a s... Read more
nipple drainage; itchy and watery eyes; itchy and watery eyes; sore arm; metallic taste; This is a spontaneous report from a contactable nurse (Patient). A 55-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. The patient took vaccine for work, and to get back to a normal life. The patient's medical history and concomitant medications were both reported as none. Shortly after her first dose of the vaccine, she developed nipple drainage. She didn't know if it was coincidental or what. She hadn't noticed it prior to the vaccine. She a work up with a mammogram and ultrasound. There were no masses or anything else. They showed no reason to have the drainage. She was unsure of her weight, but would get 140 or 150 lbs. With the first vaccine, she experienced a sore arm. It started the evening of the 30Dec2020 about 4-6 hours after the vaccine. That resolved, and she recovered completely. She also experienced a metallic taste in her mouth. It happened initially on 30Dec2020. She recovered completely. It only lasted a couple of hours. They were both not serious. She had noticed an increase in the itchy and watery eyes on an unknown date. It was ongoing and persisting. The patient underwent lab tests and procedures which included mammogram: normal, ultrasound breast: normal, weight: 140 or 150 lbs, all on an unknown date. The outcome of the nipple drainage was unknown, the outcome of the events sore arm and metallic taste was recovered on 30Dec2020, the outcome of the events increase in the itchy and watery eyes was not recovered.
55 2021-02-07 tingling, numbness, weakness I felt numbness going up my neck while I waited in line after receiving the vaccine. I thought it wa... Read more
I felt numbness going up my neck while I waited in line after receiving the vaccine. I thought it was nerves. No one asked how I felt after the vaccine and was passed along ( I told my daughter - who drove me - about my neck while at the vaccine site.) I noticed that my face was also going numb a few minutes later. As soon as we arrived at our meeting place, I told my daughter that my face(vaccine side) was also numb: "like when you get an injection for dental work." It is now ten hours after I received the vaccine, and the numbness has not seized. It is still there and with a strong tingle sensation. I also feel generally unwell with body aches and weakness.
55 2021-02-07 throat numbness Patient started by complaining of a metallic taste in their mouth shortly after administration. a fe... Read more
Patient started by complaining of a metallic taste in their mouth shortly after administration. a few minutes later it had evolved into numbness and tingling across the entire mouth and down the throat. Physical exam presented mild swelling
55 2021-02-08 feeling hot A sudden hot rush came over me all over and I felt tightness in my chest, my eyes started running co... Read more
A sudden hot rush came over me all over and I felt tightness in my chest, my eyes started running continuously, I got really congested in my face/nose and my throat felt thick, my heart was racing; it really scared me the nurse gave me Benadryl, I refused the epi-pen because I was starting to feel better and by 2 pm I was good to go
55 2021-02-08 flushing Redness, flushing, rash
55 2021-02-08 tingling, numbness Few days after first shot/dose in left arm, my fingers started tingling and going numb few times a d... Read more
Few days after first shot/dose in left arm, my fingers started tingling and going numb few times a day everyday since and up until second shot/dose on Feb 5th 2021 , even did it on same day while in 15 min holding period. Informed nurses they had me wait another 30 mins. Today is Feb 9th 2021 and still have the tingling and numbness in left fingers , has been only left fingers .
55 2021-02-08 tingling Slight swelling and tingling of lips, cheeks, and tongue. Lasted about 20 - 30 minutes from onset.... Read more
Slight swelling and tingling of lips, cheeks, and tongue. Lasted about 20 - 30 minutes from onset. Consulted EMTs onsite but as no difficulty breathing and symptoms were reducing, nothing administered by EMTs.
55 2021-02-09 migraine Worst Headache of my life! New onset high blood pressure and increase in uncontrolled migraines
55 2021-02-09 pain in extremity stress; not sleeping very well; sore arm; slight headache; This is a spontaneous report from a conta... Read more
stress; not sleeping very well; sore arm; slight headache; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the first of three reports. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) via unspecified route of administration on 19Jan2021 at single dose in left arm for COVID-19 immunization. The patient's medical history included occupational exposure to COVID-19 (adult foster care, direct line caring for people). The patient's concomitant medications were reported as no. The patient experienced sore arm on 19Jan2021, slight headache on 19Jan2021. Sore arm went away between 20Jan2021 and 21Jan2021. She has recovered completely from sore arm. She is unsure if the headache was from the vaccine or stress, or several different things, such as not sleeping very well. Headache went away, she is not 100% positive, but maybe by the 22Jan2021, and she had recovered completely. The patient asked if she can take paracetamol (TYLENOL) or ibuprofen for side effects if have to. The outcome of sore arm and slight headache was resolved. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092693 same reporter/drug, different patient/ event;US-PFIZER INC-2021092694 same reporter/drug, different patient/ event
55 2021-02-12 weakness On 1/7 (post-vaccination day 1) patient awoke with malaise, febrile with generalized weakness and ch... Read more
On 1/7 (post-vaccination day 1) patient awoke with malaise, febrile with generalized weakness and chills. Slept most of the day, peak temperature 102.5F. Consulted employee health, advised to get COVID tested - which was negative. On 1/8 (post-vaccination day 2) patient felt somewhat better with improved energy, still febrile to 101.5. Symptoms were treated with acetaminophen 650mg q6h PRN. Pt was able to return to work on post-vaccine day 3, continued to take acetaminophen PRN until post-vaccine day 6. She continued to have some generalized malaise, which resolved by post-vaccine day 14. ---- Of note, the patient has dermatomyositis, for which she normally takes azathioprine 150mg daily. This was held starting on 12/18/2020 on advice of her rheumatologist, with the thinking being to optimize the immune response for COVID vaccination. First dose of Pfizer was on 12/18. So the patient was off her immunosuppression, when she received the second dose and experienced the adverse event.
55 2021-02-13 flushing flushed feeling and dizziness soon after having vaccine. resolved after 30 min obs.
55 2021-02-14 muscle twitching, tingling, numbness Sudden twitching of left foot, feeling idenical to electrical shock/tazer, numbness, tingling sensat... Read more
Sudden twitching of left foot, feeling idenical to electrical shock/tazer, numbness, tingling sensation from my feet going up my legs,lower back, spine, shoulders and neck .NEXT DAY severe aches all over same body parts, headaches,chills,dizziness, difficulty breathing, swollen left arm(injection site(
55 2021-02-14 pain in extremity Sore arm, body aches and chills approximately 13 hours after vaccine. Adverse effects resolved with... Read more
Sore arm, body aches and chills approximately 13 hours after vaccine. Adverse effects resolved within 36 hours or less.
55 2021-02-14 tremor At 725 pm was extremely tired. Went to bed. Woke up at 1030 pm with out of control shaking and fev... Read more
At 725 pm was extremely tired. Went to bed. Woke up at 1030 pm with out of control shaking and fever of 102. Body aches and pains. Had to put on extra clothes and blankets. Went to work in am but had to leave early due to ongoing body pains and fever of 101. Also, inflamed lymph node in axilla of shot arm- very painful. Felt better by Sat late morning. Please note I am strawberry blonde as is coworker who had same response. Other individuals with us with very mild symptoms.
55 2021-02-15 weakness, tingling Pt developed weakness left leg with tingling . Similar occurred with Typhoid vaccine in past. Pt was... Read more
Pt developed weakness left leg with tingling . Similar occurred with Typhoid vaccine in past. Pt was taken to the ED by husband
55 2021-02-15 weakness, tremor Felt week, trembling, felt like passing out, palpitations, bp 144/98, pulse 96
55 2021-02-15 feeling jittery First heat in upper arm, nausea, dizziness and jittery
55 2021-02-16 pain in extremity About 20 hours after injection, in addition to sore arm, my brain felt foggy. I work on the compute... Read more
About 20 hours after injection, in addition to sore arm, my brain felt foggy. I work on the computer could not remember what to do next as I searched for needed files. At the end of the day, I signed off my computer but needed to think about how to turn off the monitor. The next day was better, but by the 3rd day out I became very sensitive to sound. On the 4th morning the brain fog got much worse, my head hurt and I felt like I was moving through life in slow motion. This continued for two whole days and I could not sleep at night due to the intensity of my headache. All of this could have been a migraine which I had in the past, but never to this extent. Past migraines were visual in nature and only lasted about an hour. By the 5th day, I started to feel normal, with the occasional headache or wave of nausea.
55 2021-02-17 feeling hot, feeling cold At 3 am I woke up feeling very cold. Took my temp at 7 am and it was 99. Had a slight headache and... Read more
At 3 am I woke up feeling very cold. Took my temp at 7 am and it was 99. Had a slight headache and warm and cold off and on. I took 1 Advil at 8 am and alternated every 4 hours with tylenol. By 2 pm I felt fine and was able to go for a walk.
55 2021-02-18 weakness About 48-hours after second COVID vax, I had serious body aches, headache, trouble focusing, feeling... Read more
About 48-hours after second COVID vax, I had serious body aches, headache, trouble focusing, feeling dizzy/ready to faint, unable to sleep, extreme exhaustion, general over all weakness lasting about 6-days.
55 2021-02-18 numbness Lip swelling on left side of face, also described numbness and tingling. "Felt like I went to the d... Read more
Lip swelling on left side of face, also described numbness and tingling. "Felt like I went to the dentist". Given 50 mg Benadryl. Numbness continued to spread through that side of face, EMS called, transported to ER.
55 2021-02-19 discomfort Patient complained of numbness on right side of tongue within 5 minutes of receiving the injection. ... Read more
Patient complained of numbness on right side of tongue within 5 minutes of receiving the injection. The numbness spread across and to the back of her tongue and patient complained that her mouth was feeling heavy and dry within 15 minutes of receiving the injection. Paramedics were on site @nd patient elected to be transported to the hospital.
55 2021-02-20 tingling 12/29 vaccination 1/7 I noticed the swelling in L arm pit; golf ball size. Tingling down arm. 1/8 P... Read more
12/29 vaccination 1/7 I noticed the swelling in L arm pit; golf ball size. Tingling down arm. 1/8 PCM; ball of fluid with hard lymph nodes. Put on antibiotics for 14 days. 1/11 mammogram; negative/zero abnormalities. Lymph nodes WERE VERY enlarged; verified.
55 2021-02-20 speech disorder Severe headache and flu like symptoms for 5 days. On the sixth day 1-11-21, I was left with a slight... Read more
Severe headache and flu like symptoms for 5 days. On the sixth day 1-11-21, I was left with a slight headache and dizziness (from 1-10 about a 3) 24 hours a day. On 2-17-21 around noon, I felt i was going to pass out. speaking, thinking were difficult. A nurse took my blood pressure it was 180 over 90. I couldn't stand and was taken to the hospital via ambulance. from noon to nine pm, (my time in the er) i felt was was going to loss all conscientiousness eleven times. I now have an appt to see a neurologist Thursday 2-25-21. I have not felt like i was going to pass out since 2-17-21. I am still left with a headache and dizziness 24 hours a day. i have had 3 appointments with a doctor to address my headache and dizziness along with my emergency room visit via ambulance.
55 2021-02-21 cold sweat Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little... Read more
Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little over 48 hours. Lymph nodes under left arm are still slightly swollen.
55 2021-02-21 hot flush, pain in extremity, cold extremities FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO H... Read more
FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO HAVE HOT FLASHES WITH FEELING THE CHILLS.. IN THE EVENING MY LEFT HAND WAS LIKE ICE BUT MY RIGHT SIDE WAS NORMAL AND WARM. CHILLS / NO FEVER . COLD HAND WAS GONE IN THE MORNING.. ABOUT 5 AM HORRIBLE HEADACHE WITH BLURRED VISION... TOOK TYLONAL AT 9AM.. FELT BETTER BY 11AM. CHILLS/AND SLEPT MOST THE DAY. I DO NOT BELIEVE I EVER HAD A FEVER. SUNDAY LEFT ARMPIT LYMPH NODES SWOLLEN AND SORE. MONDAY FEELING BETTER BUT LYMPH NODES STILL ACHE LIKE A BRUISE. I DO NOT BELIEVE I EVER HAD A FEVER.. JUST CHILLS. OH>>>. RIGHT SIDE OF MY NECK WAS STIFF FOR A BIT THE FIRST DAY.
55 2021-02-21 tingling Since the 1st shot, I have experienced a sudden onset and increasingly worsening pain in my left wr... Read more
Since the 1st shot, I have experienced a sudden onset and increasingly worsening pain in my left wrist. The immediate reaction at the time of the shot was strong tingling in my left arm. The next day, I felt sore all over my body, as well as cold/flu like symptoms for 2 days. But the wrist pain has been getting worse, and consistent. I broke that wrist 10 yrs ago, and may have some slight work related carpel tunnel. With that in mind, I can say that the current issues and pain I?m dealing with have been acute and severe since I received the first dose of the vaccine. I just received the second dose 3 days ago, and still my wrist is hurting. I am careful to make sure I don?t put too much weight on it, and often wear a wrist brace. I am currently waiting to see my primary care doctor to seek medical attention.
55 2021-02-21 tremor 2) "Stoned" From 8:15pm 2/5 thru 12:00 pm 2/7 1) Sporadic vibration of entire body 3) Constipation
55 2021-02-22 pain in extremity, feeling cold Sore arm, headache, dizzy, tired, chill. a little fever, from 6 hrs to 40 hrs after dose.
55 2021-02-23 involuntary muscle movements I developed fever 102 comes down to 101, severe headache and today I began having dyskinesia for lac... Read more
I developed fever 102 comes down to 101, severe headache and today I began having dyskinesia for lack of better words, this has persisted for more than 3 hours. Don?t know what to do or who to call. Message in to new doctor but haven?t seen him yet.
55 2021-02-23 feeling cold, weakness At 10hrs I started having severe chills. 30 min-1hr later I had severe diarrhea and vomiting 1 time.... Read more
At 10hrs I started having severe chills. 30 min-1hr later I had severe diarrhea and vomiting 1 time. Joint pain followed in ankles, knees, hips, elbows. Next day I had a severe headache with neck and mouth pain. Next day I was terribly weak.
55 2021-02-23 feeling hot 3 days after vaccination I started to have intermittent localized "heat" sensation in right side o... Read more
3 days after vaccination I started to have intermittent localized "heat" sensation in right side of skull. It would only last for a short time, a minute or two, maybe a little longer and then disappear. It was an intense heat feeling but with no pain. I was sitting quietly doing a puzzle. Because of the weekend unable to contact Dr and on call Dr did not respond to my callback request. Monday 2/15/21 talked to Dr and he it's not a vaccine reaction and it'll go away. This continued occasionally for a few days until day 5 and 6 the heat sensation increased and duration of event was much longer, lasting most of the day with short time spans between episodes. Heat sensation moved from right side of skull to top of head and was very intense, having to use a icepack for some relief. Called Dr a second time and told me to wait it out and call him next week to report status. By day 7 there is a mild headache but intensity of the heat sensation in skull has decreased to milder and less frequent again. Day 13 symptoms were almost completely resolved but by 14/15 they have returned though milder than worst symptoms were. I called Dr's office on Friday 2/19 and they said to call back next week if symptoms do not get better will refer to nruology.
55 2021-02-23 flushing Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Read more
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
55 2021-02-24 feeling hot Patient complained of "Hot everywhere, chest and heart racing" Denies SOB Bp 139/78, hr 64, oxygen ... Read more
Patient complained of "Hot everywhere, chest and heart racing" Denies SOB Bp 139/78, hr 64, oxygen level 99% on room air. EMS at patient's side at clinic, evaluated and discussed symptoms with patient. No interventions needed at this time and patient monitored for an additional 15 mins. VS remain stable and at 1045a, BP was 142/76, oxygen level 100%, HR 58 with patient states feeling better and feels she can drive home. EMS released patient.
55 2021-02-24 hot flush, flushing Pt complains of flushing, light headedness, and hot flash. Pt provided apple juice, graham crackers... Read more
Pt complains of flushing, light headedness, and hot flash. Pt provided apple juice, graham crackers and allowed to rest while MD consulted. Event occurred at 11:19 am, Vaccine received at approx 10:55 Am
55 2021-02-24 pain in extremity Severe chills, back and neck ache, fever,- onset 10:00PM to 4:30AM, residual fever reduced after Tyl... Read more
Severe chills, back and neck ache, fever,- onset 10:00PM to 4:30AM, residual fever reduced after Tylenol taken at 6:00AM; localized soreness left arm- onset 1:00PM, reduced but still present today, 2/25 at 10:48AM
55 2021-02-24 pain in extremity Arm pain, tiredness and headache
55 2021-02-24 tingling, cold sweat COVID-19 Vaccine Pt received her 1st dose of Covid-19 vaccination in her left deltiod at 1340. 12 m... Read more
COVID-19 Vaccine Pt received her 1st dose of Covid-19 vaccination in her left deltiod at 1340. 12 min later, pt stuck her head out of the doorway of her room to notify LPN that she was feeling lightheaded. LPN went to pt's room to assess. Patient laid back in exam chair. Patient mask removed. Color palor. Skin clammy, Vitals obtained, patient reports tingling in arms, legs, and feet. Patient vitals 96/67. Provider at door for eval and advised EMS notification. Patient vitals monitored. 20G IV placed at 1358 left forearm by RN x1 NSL. Color begins to return. Patient tilted back up in chair, vitals obtained and WNL. At 1423 patient stood up with stand by assistance, placed mask on herself and reports does not feel can stand at this time. Patient A&O x4. Reports lightheadedness and dizziness. Patient asks what she is to do about her second vaccine and was advised that she needs to consult with her PCP. Pt states will take Benadryl. Pt again advised to check with her PCP before having second dose or taking Benadryl with second dose. Patient advised per EMS to bring second person with for transport if cleared to receive second dose. At 1428 reports no lightheadedness or dizziness with standing. At 1429 patient ate three PB crackers with water. At 1432 patient ambulatory in halls with Medic staff by side. At 1434 back to room, reports 95% better with head, tinglining in feet and hands 90% improvement. At 1445 vitals WNL patient A&O x4. At 1449 IV pulled by RN. At 1452 patient discharged to home per self.
55 2021-02-24 tremor Shaky, felt closed in, patient believes it was anxiety, waited 15 minutes, cleared by EMS.
55 2021-02-25 feeling cold Patient reported feeling cold in the chest, and palpitations. Has history of anxiety. After observat... Read more
Patient reported feeling cold in the chest, and palpitations. Has history of anxiety. After observation, reported feeling better.
55 2021-02-25 feeling hot, feeling cold Reaction to 2nd Dose Pfizer covid19 vaccine I had second dose of the experimental Pfizer vacine Feb... Read more
Reaction to 2nd Dose Pfizer covid19 vaccine I had second dose of the experimental Pfizer vacine February 17, 2021. 1st dose was on January 27, 2021 I had reactions both times. I already reported on this site, on my 1/27/2021 reaction Received through a pharmacy clinic set up at my work. Lot#. EL9263 Received dose #2 about 10:30am on Wednesday 2/17/2021 during my work hours. (7-4pm) Paid closer attention to how I felt during the day, I could feel, I was going to be foggy in my head again. I was getting tried quickly. My left arm was not sore this time. Got home about 4pm (left a little early). Very tired, went to bed by 5:30pm. Slept, woke up to heat soup and eat. 7pm: Back to sleep. Very exhausted, my eyes were hurting (a sign I have a fever) I did not care enough to take my temp. Seemed to hard to try and find the thermometer. 7:30pm: Back to bed. Sleep. I'm very warm in my bed, sweating under arms and chest, I don't care, I can sleep thru that. Smells funny (sweat has a distinct oder) 11pm: wake up. I want to go pee, but I'm too cold to leave my warm covers. as soon as I uncover to get up, I have violent chills. I don't have chills if I stay covered. This was the exact same symtom I had on May 11, 2021 when I had the covid19 and came home sick from work. Violent chills, barely able to stand and walk alone. After midnight: I wait for someone to come upstairs to help me get up, with a blanket ready to throw over me and help me to toilet. I was too weak to call for him or to care, I just slept and waited for him to check on me. someone helped me to to tiolet, chills are under control if I have a blanket on me. The house is not cold, someone has the wood stove cranking that night, it's 70 in my bedroom. I sleep all night Wednesday. 6:30am: Thursday My eyes still hurt, I'm still hot. I don't care what my temp is. No more chills. I'm smelly from sweating all night. I'm motivated to shower, I think maybe I can do stuff today, I try to plan some things for the day. I shower and eat some oatmeal. I'm exhausted from doing those two things. My lower back/hips and neck are and shoulders are tight and sore, aches all over, especially neck. It's hard to think, brain fog, finding the right words. The injection site is not really sore though (last time it was). I have to just go back to bed. I sleep all day Thursday. Get up late afternoon to eat a little bit (soup and crackers) I try to watch TV. I can't focus on the show. I go back to bed by 5:30pm. I look at dumb funny videos on FB. Asleep by 6pm on Thursday evening. Sleep all night and wake up Friday 5am. I'm able to function and do most of my usual activities on Friday, but not very motivated to exercise or go for with dogs like I normally would do. Still stiff muscles. I do play in snow Friday night with dogs. By Saturday most of the stiffness is much better, I'm moving, walking dogs outside, moving furniture, doing my usual activities. I care about things again.
55 2021-02-25 numbness Numbness in left upper extremity, especially hand. BP 142/83, pulse 59.
55 2021-02-25 pain in extremity one day after my first vaccine, I started to feel muscular pain in my legs, it felt as if they were ... Read more
one day after my first vaccine, I started to feel muscular pain in my legs, it felt as if they were extremely sore. At first I though t it was due to a personal training session but then it would not go away (also I have been swimming for 7 month almost every day, so I should not get sore. Then about a day before the second vaccine everything went back to normal, now after the second vaccine I had the same symptoms (2/3/21 was the second dose) and they are still persisting. If I take Aleve Muscular Pain, they symptoms go away completely but come back as soom as the medication wears off. It feels like I am constantly sore, if I am active it is fine but once I sit or lay for extended periods of time I have a problem getting up.
55 2021-02-26 burning sensation Swollen lymph node (R axillary) burning sensation in armpit/radiating down arm, fatigue, joint pain.
55 2021-02-26 pain in extremity The very next day and for the next three days I had over 103 fever bodyaches nauseous fatigue for ov... Read more
The very next day and for the next three days I had over 103 fever bodyaches nauseous fatigue for over a week and the arm I get the shot and did not feel better until a week later.
55 2021-02-28 pain in extremity severe pain and swelling in left lower leg. Diagnosed with 2 DVTs 3 days later in emergency room.
55 2021-02-28 pain in extremity Headache Throwing up Stomach upset, only ate toast Sore arm Overall feeling lousy Could not go to... Read more
Headache Throwing up Stomach upset, only ate toast Sore arm Overall feeling lousy Could not go to work
55 2021-02-28 pain in extremity sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour l... Read more
sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection; about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of paiin where injection was given; hardness where injection was given; slight headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302, expiry date not reported), via an unspecified route of administration on 26Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included gastric bypass on an unknown date, pseudotumor cerebri (no attacks in over 4 years) from an unknown date to an unspecified date. Concomitant medication included cefprozil (CEFZIL), cetirizine hydrochloride (ZYRTEC), lisinopril. The patient previously took codeine and fluoride [sodium fluoride] and experienced allergies. The patient experienced slight headache on 26Jan2021 14:00, sore arm from shoulder to finger tips barely able to move it on 27Jan2021 05:00, sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection on 27Jan2021 05:00, about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of pain where injection was given on 27Jan2021 05:00, hardness where injection was given on 27Jan2021 05:00. The patient reported that hey had slight headache an hour after injection which went away a couple hours later. On morning after injection they work at 5am with sore arm from shoulder to finger tips barely able to move it. At 8:30 they got up and the pain was still pretty intense but read they needed to move it around started to do that and about an hour later the pain was just in the shoulder and site of injection. Hours later it is still a grapefruit size area of pain and hardness where injection was given. The patient recovered from slight headache on 26Jan2021, was recovering from pain in extremity, shoulder pain, vaccination site pain and vaccination site induration.
55 2021-03-01 slurring, facial paralysis Per patient's report: She received her first dose of Pfizer COVID-19 vaccine and developed soreness... Read more
Per patient's report: She received her first dose of Pfizer COVID-19 vaccine and developed soreness at localized injection site and felt sleepy, otherwise no adverse reaction signs or symptoms patient reported. On 2-19-21 at 2:30 PM she received her second dose of the Pfizer COVID-19 vaccine at a mall. She reports the lot number of the vaccine was EL9269. She was monitored for 15 minutes after receiving the second dose. She and her husband left and took the car to a car wash where she fell asleep on her way home and her husband woke her up when they got home. At about 320 or 3:25 PM, she noticed that her face felt puffy and she had a sensation that her face was sliding down, she developed tongue swelling, blurry vision, dizziness, and she reports that she was talking funny/slurring her words. Her husband got a flashlight and looked in her throat and said that her throat was swelling. She felt like falling asleep. Her husband used her EpiPen on her. The EpiPen worked right away to improve the symptoms. She took no other treatments at home. Her husband drove her to the hospital where she slept the entire way. She never developed rash, flushing, skin itching, wheezing, coughing, chest tightness, shortness of breath, nausea, vomiting, diarrhea, fevers, chills, or joint pains. She does not know if she passed out, she states it was hard to stay awake. She reports having some abdominal cramping and churning for the following 2 to 3 days afterwards. She was discharged from the hospital ED where she was never admitted. They gave her an albuterol inhaler to use every 4 hours for 6 days after she left the ED. She went home at about 10:00 PM and went to bed about 10:30 PM. She woke up at 3:00 AM crying and then fell back asleep and woke up again around 7:30 AM. She did not develop any local injection site reactions on her arm this time.
55 2021-03-01 feeling jittery shaky, jittery. Waited 15 mins extra. Evaluated by EMS-Cleared
55 2021-03-01 pain in extremity Severe Muscle pain throughout my entire left side and severe joint pain left side only. Severe arm p... Read more
Severe Muscle pain throughout my entire left side and severe joint pain left side only. Severe arm pain at the site of injection. This pain was severe visceral pain and lasted for over 6+ weeks. Only on my left side. The pain was present when simply sitting as well as during activity. There are still days when the pain returns for no reason at all. The pain is deep inside my left thigh and lower leg. I need to take ibuprophen to decrease the discomfort.
55 2021-03-02 weakness Patient received vaccination. Approximately 12 minutes following vaccination, patient complained of ... Read more
Patient received vaccination. Approximately 12 minutes following vaccination, patient complained of shortness of breath, chest pain, and weakness. Had some burning in the left, upper chest. Vital signs were stable throughout episode. EMS onsite. Baseline EKG normal. Patient requested transport to ED. Transported via EMS.
55 2021-03-02 feeling jittery Spiked blood pressure 187/157. Rapid pounding heart heaviness in chest nausea jittery dizziness
55 2021-03-04 migraine March 2, 2021 (3days after injection) 12:30pm sudden onset of severe (incapacitating) dizziness, na... Read more
March 2, 2021 (3days after injection) 12:30pm sudden onset of severe (incapacitating) dizziness, nausea and headache. Loose stool. Fatigue. Muscle pain. Joint pain. Dry eyes. March 3 same as previous day with the addition of moderate kidney pain and extreme thirst. March 4:same as previous day with addition of severe migraine
55 2021-03-04 pain in extremity None. Just sore arm.
55 2021-03-04 restless legs syndrome, tingling I have called and reported this, I was told to do this by Vaers after reporting it. My first shot... Read more
I have called and reported this, I was told to do this by Vaers after reporting it. My first shot was on 12/22/20 -was nauseous and sick with cold chills, body ache and pain, slight fever at night, next day felt like a truck hit me, total body aches, some restless leg syndrome, fatigue and joint pain lasting almost 2 weeks second shot was 1/11/21. I told them that I had a reaction to the shot, was feeling better that day, and was told it would be ok to get second shot. so I did, I am under doctors care, severe restless leg syndrome, joint pain, fatigue, pain shooting down legs and arms. at times feels like pins inside me. blood work every 2 weeks some in between. low WBC. Has gone up. on steroids and anti antiflamitory meds that are not helping. stay awake from pain that wakes me up. problems are not getting better.
55 2021-03-05 pain in extremity, tremor Foggy brain, hand tremors, chills, fever, feet throbbing, muscle aches, joint pain , nasal congesti... Read more
Foggy brain, hand tremors, chills, fever, feet throbbing, muscle aches, joint pain , nasal congestion, headache, earache
55 2021-03-05 pain in extremity Extreme pain in right arm, worst in arm pit. Lymph nodes area. Started 25hrs after injection. Inc... Read more
Extreme pain in right arm, worst in arm pit. Lymph nodes area. Started 25hrs after injection. Including fever. Fever gone in 12 hours. Lymph node pain and swelling continues including bruising under right arm. Left arm swelling very minimal but right nodes continue to get worse 3 days in. Today
55 2021-03-06 numbness, tingling Feet and leg hands arms back. Pins and needles numb
55 2021-03-07 inability to speak Immediately after IM injection, patient stated she had a funny taste and reported lips felt like the... Read more
Immediately after IM injection, patient stated she had a funny taste and reported lips felt like they were tingling. Patient then began having difficulty breathing with throat swelling. Patient was unable to swallow and had difficulty speaking. Epinephrine was administered and EMS was notified. Patient improved after epinephrine administration and was transported by EMS to hospital.
55 2021-03-07 tingling, numbness C/o tingling left arm/shoulder 15 minutes after injection. Then increased tightening left side neck ... Read more
C/o tingling left arm/shoulder 15 minutes after injection. Then increased tightening left side neck and numbness of neck and jaw with extension from her ear to nose. Felt some tightening of chest on 3/4/21 at noon. took benadryl. Majority of numbness subsided on Friday 3/5 however still having numbness at hairline on opposite side of face.
55 2021-03-08 flushing headache/nausea/flushing/chest tightness/paroxysmal breathing within 5 minutes of vaccine administra... Read more
headache/nausea/flushing/chest tightness/paroxysmal breathing within 5 minutes of vaccine administration
55 2021-03-08 tingling, numbness Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseate... Read more
Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseated; headache. I felt like everything was it was swollen and tight - I couldn't wear my watch on my wrist. Almost like lymph system - nothing tight in my arm pits; felt like my pants were too tight in my groin - my body was swollen by my lymph nodes. Developed all kinds of gas in my stomach. I was having chest pains - 3 or 4 times a month before the vaccine - after the vaccine - I'm having the chest pains daily. That lasted for about 12 hours. Next day, 22nd, I developed diarrhea for 24 hours. 9 days later - I got numbness and tingling started radiating down my wrist into my fingers; lower calf to my feet and I had to go see my orthopedic surgeon - it was radiating down into my feet. He sent me to a podiatrist and he doesn't know. Those symptoms still haven't resolved. When I wake up - it's a low level and by night time my feet would get so numb and tingly it drove me crazy and then it went into my hands. Went to my doctor on March 2nd - my doctor thought I was having a histamine response in my body. I took an antihistamine - and half my symptoms went away. My esophagus is going into spasms - and I am trying to see a GI specialist. I was taking Benadryl last week but I got too tired. So I take 2 Benadryl at night now and I'm taking a Zyrtec (generic) at the day - it takes the edge off but doesn't resolve the symptoms entirely. Eleven day - I developed a floaty in my right eye - a black spot. I went to my eye doctor - it looks like my eye is healthy -but floaty is not going away. So talking on the phone, My throat is starting to swell up and feels like something back there and the more I talk pretty soon I start losing my voice (happening now on the phone). They added to my meds: Pepsid, Viscus lidocaine; Mylanta after every meal; Pantoprazole; Sucralfate; gave me another one but I haven't taken it yet: Hyoscyamine - for really bad spasms and I haven't had another really bad one since I went to ER (besides taking the antihistamines). I have seen 5 specialists all together.
55 2021-03-08 tenderness Quarter size lump, redness , rash. Inflammation, painful if pressure placed on area.
55 2021-03-09 pain in extremity Soreness of arm, low-grade fever, chills, body aches, sore throat started around 8 AM the day after ... Read more
Soreness of arm, low-grade fever, chills, body aches, sore throat started around 8 AM the day after the vaccine. Felt progressively worse throughout the day. Took ibuprofen, slept and after a several hours started feeling better. Day #2 felt fine; asymptomatic Day #3 felt tired, slight headache Day #4 normal
55 2021-03-09 pain in extremity 1st injection (1/7/21)-12 hours later ( approx 3 a.m.) felt achy, fever up to 102.7degrees, sore arm... Read more
1st injection (1/7/21)-12 hours later ( approx 3 a.m.) felt achy, fever up to 102.7degrees, sore arm, fatigue and headache. Took tylenol several time through the day and fever resolved approx 7pm on 1/8/21. Approx 11:00pm that day I woke up dizzy and felt chest heaviness, but went back to sleep. Woke up again after midnight and sat up in bed and felt like I was falling out of the bed (extremely dizzy) and decided to check my oxygen level due to me having prn shortness of breath since contacting covid in July 2020 and noticed that my heart rate was 186 bpm. Went to ER and MD was told that I had a covid shot the she wasn't sure if that what caused the SVT and could not tell me if I should or shouldn't take injection #2. Injection #2-(1/29/21) 4 hours after taking this injection started with low grade temp, sore arm and achy all over and noticed my heartrate was in the 120's. Woke up next morning temp was 103.0. Took tylenol troughout day and that day. Heart rate was in the upper 150's. I did not go to the ER. The next day heart rate continues 140-150.
55 2021-03-09 pain in extremity rash/Rash is about 6 " below injection site; Large hot itchy welts; Large hot itchy welts; Large hot... Read more
rash/Rash is about 6 " below injection site; Large hot itchy welts; Large hot itchy welts; Large hot itchy welts/warmth; injection site has small bruise; arm is very sore; This is a spontaneous report from a contactable consumer (patient). A 55-years-oldnon-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL9263, via an unspecified route of administration from 06Feb2021 12:00 (at the age of 55 years old) as a SINGLE DOSE in the left arm for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing, supraventricular tachycardia (SVT) from an unknown date and unknown if ongoing. The patient did not have allergies. Concomitant medication included metoprolol, ibuprofen, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]). The patient did not receive other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Feb2021 12:00, the patient experienced large hot itchy welts. Turned into one large spot. Approximately 4 inches around. Rash began appearing about 2 hours after injection (06Feb2021 14:00). Rash is about 6 " below injection site. Actual injection site has small bruise from 06Feb2021 12:00, and arm is very sore from 06Feb2021 12:00. Rash and warmth still present after 24 hours. No treatment was received for the events. Outcome of large hot itchy welts, injection site has small bruise, Large hot itchy welts/warmth, arm is very sore, rash/Rash is about 6 " below injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
55 2021-03-09 tingling, pain in extremity Shot was given approximately at 4:50. I left the store after being watched at 5:15. Went to pick u... Read more
Shot was given approximately at 4:50. I left the store after being watched at 5:15. Went to pick up food for supper. While waiting for the food, I was seeing spots (like when you have a photo taken with a flash). This lasted for about 20 minutes. This went away so I continued on my way home. As I was driving I notice that my face was tingling and my eyes seemed to be really dry. Both lasted about 30 minutes. Then I had the headache, arm soreness and light headedness that are "normal" side effects.
55 2021-03-09 tingling I received the shot in the left arm. Sat for 15 minutes with staff and felt perfectly fine. Started ... Read more
I received the shot in the left arm. Sat for 15 minutes with staff and felt perfectly fine. Started to drive home and in 5 minutes began to feel tingling in mouth, tongue, lips face and itching in throat. Kept checking lips and tongue to see if they were swelling, (which they were not). Event lasted about 15-20 minutes and then subsided after 40 minutes. Itching in throat lasted 24 hours. Whole body felt itchy the next few days.
55 2021-03-10 weakness extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chil... Read more
extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
55 2021-03-10 numbness, tingling Having tingling on the left side of my face and left leg. Feels like my leg is asleep. My face feel... Read more
Having tingling on the left side of my face and left leg. Feels like my leg is asleep. My face feels like after you go to the dentist and the numbing is going away. It has gotten better but still having some numbness under my left eye and inside my left nostril.
55 2021-03-10 pain in extremity, migraine Had swelling at site and lips swelled up from first dose symmetrically but did not affect airway, h... Read more
Had swelling at site and lips swelled up from first dose symmetrically but did not affect airway, had chills , and malaise , 2nd dose had more chills fatigue , GI upset , nausea , swelling at site of injection , arm pain couple of small hives on arm no lip swelling with second dose and migranous headache . Was not as bad as prior reactions to flu vaccine but enough to not feel well enough to go in to work Monday . Was able to go to work Tues though after Sat appt .
55 2021-03-10 pain in extremity I had a severe headache, sore arm, fatigue and overall malaise for two days.
55 2021-03-10 pain in extremity Second morning after vaccination I had an 8 cm round, red, warm, rash at the injection site on my r... Read more
Second morning after vaccination I had an 8 cm round, red, warm, rash at the injection site on my right arm with pain which slowly resolved over a period of days. I also had fatigue and chills without fever for approximately 24 hours. Now, two months later, I have significant atrophy of the soft tissues/muscle of my arm at the injection site directly beneath the area of the red rash. I have not seen this atrophy in any discussion of delayed reactions. No other symptoms. I have photos of the arm from January 7 and March 11, 2021.
55 2021-03-11 migraine After my second dose vaccine, I experienced headaches along with nausea. No vomiting. Headaches beca... Read more
After my second dose vaccine, I experienced headaches along with nausea. No vomiting. Headaches became migraines and I went to my doctor's office because my headaches were getting worse and I had started to throw up. I also had body aches, nausea and vomiting which lasted three das. My doctor prescribe anti nausea medications, prescribe Zofran, gave me sleeping medicine as well as a Toradol medication. I also received my first dose injection, lot#: EH9899 on 12-18-2020 at 8am. I developed headaches for two hours, little bit of nausea for 45 min and had a sore arm.
55 2021-03-11 pain in extremity, weakness Chills, weakness Shoulder and arm pain Joint pain Fatigue Fever 100.1-100.2 Brain fog Tinnitis Felt... Read more
Chills, weakness Shoulder and arm pain Joint pain Fatigue Fever 100.1-100.2 Brain fog Tinnitis Felt like the Flu, and would not describe as mild. Symtoms began the evening after the shot. Fever gone but still unusually tired as of 3/12/2021 at 4:00 pm. Missed 3 days of work.
55 2021-03-11 pain in extremity arm was sore & headache right away, half hour later felt very tired, 3 hours later my heart starti... Read more
arm was sore & headache right away, half hour later felt very tired, 3 hours later my heart starting racing & my throat felt swollen I didn't seek medical treatment because I have an epi pen in my house ( i have a granddaughter allergic to peanuts) I went to bed, woke up around 4am heart racing & swollen throat were gone
55 2021-03-12 numbness Patient received their first Pfizer Covid vaccine in the left arm and she reported numbness in her... Read more
Patient received their first Pfizer Covid vaccine in the left arm and she reported numbness in her face and left side. Patient was advised to go into urgent care or the ER.
55 2021-03-13 feeling hot, muscle spasms Patient reported sudden onset of muscle spasms to her left neck and trapezius. Reports neck feels ho... Read more
Patient reported sudden onset of muscle spasms to her left neck and trapezius. Reports neck feels hot. Reported feeling lightheaded.
55 2021-03-14 burning sensation About 5 minutes after injection I had stiffness in right hand and neck and shoulders. The stiffness... Read more
About 5 minutes after injection I had stiffness in right hand and neck and shoulders. The stiffness started to go away at 20 minutes later. 15 minutes after I left test site (35 minutes after injections, my tongue, lips, and face started swelling and had trouble swallowing an hour later). I ate a frozen popsicle and the swelling in tongue and lips started to go down. Hours later I took my blood pressure medicine (Lisinopril) I started to have tightness in face and jaw area, burning sensations in ears, jaws and back of my head and headaches. I contacted health care provider after hours number. They scheduled a video appointment with doctor. The doctor advised me not to take blood pressure and any other medications for another day and to put warm compressor on shoulders to relieve some of the tightness in jaws. I was also advised to call 911 or immediately come to healthcare facility if swelling re-occurred. A follow up appointment with primary care provider is scheduled on 3/17/21. I do not have any symptoms at the time of this report, March 15, 2021 at 1:23 pm.
55 2021-03-14 feeling cold, weakness Feeling weak and tired/achy about 12 hours after shot; woke up in the morning and went to work but c... Read more
Feeling weak and tired/achy about 12 hours after shot; woke up in the morning and went to work but couldn't get warm - cold & chilled all day, headache, muscle & joint achiness; took Tylenol for achiness and headache, felt better about 48 hours after shot, but still feel a bit "off" 4 days after shot
55 2021-03-14 grand mal seizure tonic-clonic seizure Patient has a history of seizure disorders, dissociative convulsions, and head ... Read more
tonic-clonic seizure Patient has a history of seizure disorders, dissociative convulsions, and head trauma.
55 2021-03-14 pain in extremity Left arm pain day after injection followed by left arm pit swelling of gland with pain, low grade fe... Read more
Left arm pain day after injection followed by left arm pit swelling of gland with pain, low grade fever,headache.
55 2021-03-14 tingling Tingling stinging in hands after second shot Trouble breathing since second dose
55 2021-03-15 burning sensation, discomfort, numbness Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on t... Read more
Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on the back of my neck and head, and numbness in my face around my checks, nose, and mouth area. These side effects continued for the next 24 hours along with headache, body aches, tiredness, dizziness, and nausea. I took Tylenol and rested for the first 24 hours, which helped and the side effects subsided. After 24 hours, I still felt tiredness, dizziness, nausea, and tingling/numbness on my left side of my mouth.
55 2021-03-15 feeling hot, discomfort Shortly after leaving, the patient said that she began to feel very warm; she also said that her thr... Read more
Shortly after leaving, the patient said that she began to feel very warm; she also said that her throat felt itchy. She went to the store to buy some medication, but then noticed that she was diaphoretic, and she had pressure in her upper chest and neck. She presented to the ER with these symptoms.
55 2021-03-15 numbness Numbness in arm, fainting, nausea for a thirty minute period. Treated in emergency room for nausea
55 2021-03-15 muscle spasms Sleeping 1 full day after vaccine tiredness, Back Pain and spasms for 4 days, Headache for 1 day, ... Read more
Sleeping 1 full day after vaccine tiredness, Back Pain and spasms for 4 days, Headache for 1 day, Vivid Dreams, feeling out of it, increased pulse 110, increased blood pressure 160/80 not a hypertensive patient, dizziness and light headedness. Increase vitals day 2 Back pain started late in the 2nd day and ended on 3/16.
55 2021-03-15 tenderness, facial pain Day 1 and 2- very tired Day 3- bruised, very tender, slightly painful feeling in left temple. Sore ... Read more
Day 1 and 2- very tired Day 3- bruised, very tender, slightly painful feeling in left temple. Sore when biting down on anything, slightly throbbing otherwise. Day 4- soreness in temple subsiding
55 2021-03-16 flushing, feeling hot After sitting for the required 15 minutes, stood up and felt light headed and fuzzy. Waited for it t... Read more
After sitting for the required 15 minutes, stood up and felt light headed and fuzzy. Waited for it to pass and walked to car. Sat in car for a few minutes, drank some water and had a few bites of a protein bar. Felt hot, flushed, broke out in an all over sweat. Waited about 5 minutes, continued to sip water and nibble on protein bar. It eventually passed. On and off headache for next couple of hours. Only some injection sight tenderness since then.
55 2021-03-16 flushing Three days after receiving vaccination I became extremely nauseous, had facial flushing and spikes i... Read more
Three days after receiving vaccination I became extremely nauseous, had facial flushing and spikes in blood pressure. This has continued for four additional days. Visited doctors office on third day of sickness. Was given promethazine for nausea.
55 2021-03-16 numbness redness of the face and numbness of her face for couple of mins
55 2021-03-16 pain in extremity I?m suffering from right arm pain that began a week after my first injection. I?m currently in a lot... Read more
I?m suffering from right arm pain that began a week after my first injection. I?m currently in a lot of pain, unable to use my arm. I?m taking Aleve and Tylenol intermittently.
55 2021-03-17 hot flush Pt reported palpitations and feeling flushed , as well as vertigo. Symptoms resolved within 5-10 m... Read more
Pt reported palpitations and feeling flushed , as well as vertigo. Symptoms resolved within 5-10 minutes with rest. No uticaria, dyspnea, weakness. Pt departed after 15 additional minutes
55 2021-03-17 numbness, tingling, pain in extremity right arm felt like needles and sensitive to the touch; all joints hurt more than usual; difficult t... Read more
right arm felt like needles and sensitive to the touch; all joints hurt more than usual; difficult to concentrate; The right arm felt a little dormant with a little tiredness and pain; The right arm felt a little dormant with a little tiredness and pain; This is a spontaneous report from a contactable female consumer reported for herself. A 55-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EN5318) in left arm 14:15 on 17Feb2021 for Covid-19 immunization. The patient had her first injection (lot number EN5318) in left arm 2:15PM on 27Jan2021. The patient had a history of some age related arthritis and had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had not received other medications within 2 weeks of vaccination. The vaccine was applied in the left arm, close to shoulder. About one hour later, the right arm felt a little dormant with a little tiredness and pain. 18 hours later the right arm felt like needles and sensitive to the touch. Additionally, all joints hurt more than usual and it was difficult to concentrate. No headache nor fever. After 48 hours patient felt normal. No Tylenol was taken. No treatment was received for the events. The patient had recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter considered all events were non-serious.
55 2021-03-17 night sweats pass out; 11 hours post injection developed severe lumber pain that radiated to front; the pain inte... Read more
pass out; 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe/lower lumbar pain; dull headaches; Some night sweats; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265) on left arm intramuscularly from 28Jan2021 15:00 (03:00 PM) at single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), allergies to trees, pollen, grasses and latex. Concomitant medication included omeprazole (PRILOSEC), sucralfate (CARAFATE), sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , minerals nos/ vitamins nos (OPTISOURCE CHEWABLE VITAMIN & MINERAL SUPPLEMENT). There was no other vaccine in four weeks. The patient historical vaccine included bnt162b2 (lot number: EL1284) for first dose on 04Jan2021, 03:00 PM, Intramuscularly, left arm, for covid-19 immunisation. The patient previously took metoclopramide (REGLAN), pethidine hydrochloride (DEMEROL) and hydrochlorothiazide (HCTZ) and all had allergies. On 29Jan2021, 02:00 AM, 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe it caused me to pass out. In Jan 2021, 20 hours to 48 hours post injection continued to have dull headaches and lower lumbar pain achy at this point. Some night sweats. The vaccination facility type is hospital. There was no covid prior vaccination and covid tested post vaccination. There was no treatment for the events. The events were not result in emergency room visit or physician office visit. The outcome the events recovered in Jan2021.; Sender's Comments: Based on the compatible time association, the event back pain and loss of consciousness are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
55 2021-03-17 pain in extremity Swelling and painful/stinging lips. No immediate reaction, sore arm and a little fluish the next d... Read more
Swelling and painful/stinging lips. No immediate reaction, sore arm and a little fluish the next day
55 2021-03-18 flushing Pt received vaccine and reported feeling flush and shaky. Pt was escorted via wheelchair from a vacc... Read more
Pt received vaccine and reported feeling flush and shaky. Pt was escorted via wheelchair from a vaccination pod to an observation unit where she was observed and monitored for +30 minutes. Vitals were 114/74, O2 94%, HR 80. Pt reported using albuterol as a rescue inhaler and G Breo regularly. Pt verified symptoms had subsided and was escorted via wheelchair from the premise.
55 2021-03-18 numbness, tingling, pain in extremity Just after the dose was injected, my face become numbing and I felt tingling sensation. Right after... Read more
Just after the dose was injected, my face become numbing and I felt tingling sensation. Right after this it was very hard to swallow and breath. This last around 25 minutes. Then my muscles in my legs got numb. Pain in the left arm. After 22 hours my face is still partially numb.
55 2021-03-18 migraine, pain in extremity Migraine headaches, fever of 100.8, severe body aches, severe body chills, left upper arm swollen an... Read more
Migraine headaches, fever of 100.8, severe body aches, severe body chills, left upper arm swollen and major pain in whole arm, sneezing and severe running nose and nauseated really bad
55 2021-03-18 tingling Lightheadedness, dizziness, tingling in toes and fingers, and headache.
55 2021-03-19 night sweats With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pai... Read more
With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pain/swollen glands/- 2 days later pain traveled to mouth and throat- on day 5 in the evening starting run a fever with severe night sweats/Chills/no appetite/fatigue . I have never experienced this feeling before --- the amount of sweat coming out of my body was like a demon was being released. I felt these severe symptoms for about 4 days . One week later from onset of night sweats/c hills/ fatigue I still have these symptoms but not as severe.
55 2021-03-20 burning sensation, flushing A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in... Read more
A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in mouth was noted; intense flushing and burning sensation from my waist up, mostly in the chest, developed; intense flushing and burning sensation from my waist up, mostly in the chest, developed; increase in heart rate, but no tachycardia; elevation of blood pressure; This is a spontaneous report from a contactable 55-year-old female physician reported for herself. A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection ,Lot number: FM 9809) on her right arm intramuscularly on 09Feb2021 (at the age of 55-years-old ) at single dose for covid-19 immunisation.Medical history included HBP, RA, Hyperlipidemia. Allergies to medications included NSAID'S. Other medications which patient received within 2 weeks of vaccination included Irbesartan 150mg, Toprol 100mg XL, Plaquenil 200mg, Simvastatin 10mg, Folic Acid 1mg, Methotrexate 15mg sq weekly. On 09Feb2021 14.15 it was reported that less than one minute after receiving the vaccine, a metallic taste and burning sensation in mouth was noted , and then an intense flushing and burning sensation from her waist up, mostly in the chest, developed. There was some increase in heart rate, but no tachycardia, no skin and/or respiratory manifestations. There was mild elevation of blood pressure. The symptoms resolved without any medication and lasted about 10 -15 minutes. No more symptoms or complaints thereafter. The events were considered as non-serious by reporter. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.No treatment received for events. The outcome of the events was reovered.
55 2021-03-20 tremor pt got light headed and took a tumble after the 15 minute weight, stated she felt light headed and d... Read more
pt got light headed and took a tumble after the 15 minute weight, stated she felt light headed and dizzy. after recovering from the light headedness she stood up and complained of chest tightness and difficulty breathing, ems stated blood pressure increased and heart rate as well. she complained of a shakey feeling. she was sent on ambulance to the hospital after 45 minutes in EMS tent.
55 2021-03-21 hot flush, pain in extremity On 3/21/21 - 30 minutes after the shot I developed a bad headache. Took Tylenol. 3/22/21 - At 1:... Read more
On 3/21/21 - 30 minutes after the shot I developed a bad headache. Took Tylenol. 3/22/21 - At 1:30 AM body aches, legs and feet throbbing. Left-arm very painful. Intense headache. 4:00 AM chills and severe pain in my limbs. Limbs felt heavy. 12:00PM soaked feet in Epsom Salt for pain relief. 1:15 PM felt queasy then had diarrhea. Afterwards, nn my way upstairs legs felt heavy, flash of heat in my head and almost fainted. Been in bed and symptoms have not subsided. Still taking Tylenol.
55 2021-03-21 pain in extremity, weakness Friday afternoon: left arm started getting sore. by Friday evening developed pounding headache, comp... Read more
Friday afternoon: left arm started getting sore. by Friday evening developed pounding headache, complete body aches, fever through out the night. took Tylenol around 3 am Saturday morning. Saturday: chills, headache, feverish, and weakness. By Midnight was feeling better. Sunday 3/21/2021 back to normal self
55 2021-03-21 tingling 1615- complained of feeling nauseated, tingling fingers, BP-176/135, p-91, O2 sat- 98%, patient wi... Read more
1615- complained of feeling nauseated, tingling fingers, BP-176/135, p-91, O2 sat- 98%, patient with small amount clear emesis given Zofran 4 mg SL 1626- BP- 173/95, p-84, O2 sat- 96% 1644- p-77, BP-164/94, O 2 sat- 97% Feeling better, no further nausea, no further dizziness Home with family members with instructions to seek immediate care if any shortness of breath, trouble swallowing, swelling of lips, tongue or mouth
55 2021-03-22 breast pain Sharp pains in left armpit/upper breast and now sore and painful especially to the touch.
55 2021-03-22 difficulty speaking, flushing - Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors ... Read more
- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors and ID team discussed risks of COVID vaccine and determined low risk due to no similar components between flu vaccine and COVID vaccine - Pt received first dose of COVID vaccine today (3/22/21) around 1230 - Within 10 minutes of injection, pt felt nauseous and was flush. She was given a drink and snack, monitored for 30 minutes, and felt better ? went back to work upstairs - 4 hours post injection (~1630) pt came to ED - itchy throat, hoarseness, urge to clear her throat, chest heaviness - In ED, pt has received methylprednisolone 125 mg, famotidine 20 mg, diphenhydramine 25 mg, duonebs, epinephrine 0.3 mg IM, and fluids with improvement. - Pt is being admitted for further monitoring
55 2021-03-22 flushing Patient received vaccine at CVS. With in 5 min developed flushing. Patient given Benadryl and epi at... Read more
Patient received vaccine at CVS. With in 5 min developed flushing. Patient given Benadryl and epi at CVS, transported to ER. Patient develops difficulty swallowing and a rash, monitored and Evaluated. D/C home with PO prednisone.
55 2021-03-22 numbness After about 40 minutes post-vaccination in my left arm, I experienced some numbness on left side of ... Read more
After about 40 minutes post-vaccination in my left arm, I experienced some numbness on left side of my chin/cheek and general nausea. The numbness proceeded up the left side of my face w/no visible drooping, and also included my left arm, left leg and left side of my tongue. Numbness level was like what it feels like as dental novocaine wears off. Went to ER and had CT scan, bloodwork, and an MRI which ruled out any stroke concerns. Monday, day after vaccine, I was tired (understandably since in the ER until 4 AM Monday) and had some residual numbness, mostly on my face, some on my arm/leg. Nausea went away after an hour or so on Sunday afternoon and I ate variety of food w/no issues on Sunday and forward. Still have some of the numbness sensations as of Tuesday, mostly feel it in my face. Overall, it feels like half my body got the vaccine and the other half wasn't impacted.
55 2021-03-22 pain in extremity face swelling, rash on cheeks, eyes,nose, sore arm,
55 2021-03-22 tremor shaking. Evaluated by EMS-Cleared
55 2021-03-23 numbness Numbness and swelling in left cheek and under chin, feeling faint.
55 2021-03-23 migraine I started feeling extremely tired about 5 hours after the 1st does of Pfizer vaccine (have not had a... Read more
I started feeling extremely tired about 5 hours after the 1st does of Pfizer vaccine (have not had any soreness at injection site at all). Other symptoms presented themselves much later: Headache/Migraine onset at approximately 4:30am (15 hrs post vaccination) that lasted for about 6 hours, treated with Advil and strong coffee. Chills set in at approximately 9:30am (20 hrs post vaccination) and lasted for about 3 hours then dissipated. As of 1:30pm on 24 March (24 hrs post vaccination) all symptoms are no longer present.
55 2021-03-23 tenderness, breast pain 3/22/21: Pain and swelling at injection site around 4p. Chills, nausea and extreme exhaustion around... Read more
3/22/21: Pain and swelling at injection site around 4p. Chills, nausea and extreme exhaustion around 5p. Just got in the bed to sleep off the symptoms about 6:15p. 3/23/21: Pain and swelling at injection site persisted. Also had pain under left arm that radiated to left breast, down left side, up the neck and upper left back as day progressed. Went to take a shower around 4:30p and noticed the lump/swelling under left arm, beside left breast. Area of the lump was tender to the touch. Went to Patient first to get checked out and was prescribed steroids to reduce the pain, swelling and inflammation.
55 2021-03-24 weakness, burning sensation Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensat... Read more
Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensation all over body, especially breast area. Patient has also blue spots on upper Thigh. Patient also complaining of weakness, body aches, and abdominal pain sometimes. Patient also today is complaining about head ache and feeling confused.
55 2021-03-24 cold sweat Patient developed headache, nausea, dizziness and clammy skin about 15 minutes after vaccination. Sh... Read more
Patient developed headache, nausea, dizziness and clammy skin about 15 minutes after vaccination. She was assessed by the RN; pulse was 85-95 bpm, and O2 saturation was 93% on room air (normal per patient). Patient reported increased headache pain to 8/10 and increased dizziness; she was taken to the emergency department.
55 2021-03-24 feeling hot Hotness in chest area and stomach, nausea, and headache, and anxiety feeling. Which lasted about 2 ... Read more
Hotness in chest area and stomach, nausea, and headache, and anxiety feeling. Which lasted about 2 hours but headache lasted until next day.
55 2021-03-24 flushing Patient has a recent history of breast cancer on chemo and radiation. After 1st dose had allergic re... Read more
Patient has a recent history of breast cancer on chemo and radiation. After 1st dose had allergic reaction was given epi and transported to ED. Patient pre medicated prior to arrival today, 40mg PO prednisone yesterday then 40mg PO prednisone & 50mg PO Benadryl today. Approx 7 mins after injection #2 tonight patient complained of shortness of breath, coughing with laryngeal spasm, flushed face. Vitals Bp 239/129 HR 126 Sats 96 RR26 MD on site requested to administer 0.3mg Epi IM and transfer to ED. Patient took own albuterol. At approximately 1721, administered IM EPI 0.3mg. Patient transported to ED at 1735.
55 2021-03-24 numbness, tingling, pain in extremity After receiving her vaccine client states she has tingling, numbness and pain in the arm she was vac... Read more
After receiving her vaccine client states she has tingling, numbness and pain in the arm she was vaccinated in. Vital signs obtained by EMS. BP 114/78, HR 88, 98% O2 sat. Client stated she feels better. Client discharged home.
55 2021-03-24 numbness, tingling Pt c/o numbness/tingling in arm. Assessment showed speech not slurred, equal grip bilaterally. Hig... Read more
Pt c/o numbness/tingling in arm. Assessment showed speech not slurred, equal grip bilaterally. High BP is abnormal for patient, but pt stated anxiety due to shot. Pt refused transport, advised to contact PCP if HTN, symptoms occurs
55 2021-03-24 muscle spasms After receiving 1st injection on 3/19/21, I develeoped severe back pain on 3/20/21. Pain started in... Read more
After receiving 1st injection on 3/19/21, I develeoped severe back pain on 3/20/21. Pain started in lower back and progressed to mid/upper back, sides and under front ribcage over the next 6 days. Muscle spasms accompanied back pain. I had a fever of 99.9 as well. Fever broke on 3/25/21 and pain has started to lessen somewhat on this date. This is by far the worst back pain I've ever experienced and was very strange in that it moved from lower to mid back over the course of 5 days. I've never had back spasms before.
55 2021-03-25 migraine, muscle spasms Joint pain swelling abdominal pain severe constipation, temporary obstipation, joint heat, chest pai... Read more
Joint pain swelling abdominal pain severe constipation, temporary obstipation, joint heat, chest pain, peripheral vascular prominence fatigue unilateral muscle cramp.back pain exacerbation and return of migraine headaches resolved after hysterectomy.
55 2021-03-25 pain in extremity Having all kinds of trouble in walking; sick on my stomach and was throwing up; sick on my stomach a... Read more
Having all kinds of trouble in walking; sick on my stomach and was throwing up; sick on my stomach and was throwing up; Pain; sick on my stomach and was throwing up; Headache; Hips, legs and neck is a little swelled; my hip down were pain; arm was very sore; could not move arm; arm was very sore; could not move arm; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received second dose of BNT162B2 (pfizer-biontech covid-19 vaccine, Formulation: solution for injection, lot number: EL3246; Expiration Date: 30Apr2021) via intramuscularly on right arm as single dose on 14Jan2021 for covid-19 immunisation. The patient received first dose on 24Dec2020 and she didn't have any reaction, no nothing. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient work at the hospital in the kitchen and don't have any health issues before, none. Laboratory data included, Multiple blood work, 3 MRIs, Chest X-ray, EKG, EMG. On 15Jan2021, after receiving second dose patient stated, it's been almost a month, she had all kinds of trouble, in walking, hips, legs and neck is a little swelled. she had a major headache the last four days, her arm was very sore, she was sick on her stomach, she was throwing up. The next day she could hardly walk. She used a walker. She was out of work and did physical therapy, from her hip down were pain and was hard to walk and it spend like that for a month now and it's now 17Feb2021. Patient hospitalized cause she couldn't walk. She spent six days in a hospital (28Jan2021 to 3Feb2021), they are not sure if it is related to that. They are not even sure what's going on. They can't tell what's wrong. Patient started the treatment with "Gabapentin-300 mg, twice a day, still taking, start date: Consumer stated, " she don't remember. Acetaminophen-codeine 3-1 tab every 6 hours as needed, still taking, start date: Consumer stated, "Last week, I don't know." She was just wondering why she had all these side effects. The outcome of the event she was sick on her stomach was unknown and all of the event was not recovered.
55 2021-03-25 pain in extremity I woke up with extreme pain and swelling at the base of my left big toe and the ball of my left foot... Read more
I woke up with extreme pain and swelling at the base of my left big toe and the ball of my left foot. I suspect it was a gout attack. I've had attacks like this before, followed by bloodwork which did NOT show elevated uric acid levels, so I've been told it's arthritis, not gout. I still think it's arthritis. The swelling/pain has made it difficult to walk, but it's decreasing in intensity as the days pass. I've been taking ibuprofen regularly since the onset of symptoms and discontinued use of HCTZ and potassium supplements..
55 2021-03-25 pain in extremity very sore arm for four days and fever, headache and body aches on second night
55 2021-03-25 pain in extremity muscle pain; joint pain; I could barely walk; Temperature increased slightly; sweating; soreness in ... Read more
muscle pain; joint pain; I could barely walk; Temperature increased slightly; sweating; soreness in the arm; Headache; Tiredness; chills; This is a spontaneous report from a contactable consumer. A 55-year-old female patient (non-pregnant) received first dose of BNT162B2 (lot number El9267), via an unspecified route of administration on left arm on 14Feb2021 at 13:00 at the age of 55 year old at a single dose for COVID-19 immunisation at hospital. Medical history included thyroid problems and hypertension. No Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (LEVOXYL) and lisinopril. The patient received other medications within 2 weeks of vaccination. On 07Feb2021 at 16:00, the patient experienced soreness in the arm, headache, tiredness, chills, on 08Feb2021, the next morning with severe soreness in the arm, very severe muscle and joint pain and could barely walk. On 08Feb2021, temperature increased slightly. Chills and sweating. It felt worse than the flu! This morning feeling better, still weak but better. Patient did take Alene to help with the muscle pain, soreness and could barely walk. Seriousness of all the events was reported as non-serious. No treatment was received in response to the adverse events temperature increased slightly, headache, tiredness, chills, joint pain and sweating. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from all the events.
55 2021-03-25 tingling, difficulty speaking, speech disorder pt stated that she felt a little funny and lightheaded after taking the covid vax. Her skin started... Read more
pt stated that she felt a little funny and lightheaded after taking the covid vax. Her skin started feeling a little prickly and she developed rash on her extremities and upper chest. She started having trouble speaking, her voice got hoarse and she started coughing. She had an intense headache, fatigue and could barely speak. She was taken to the UrgentCare . She was given EPI pen and steroids injections. Paramedics were called and she was taken to a hospital, where she was monitored after getting those injections and given Pepcid and IV fluids. She was diagnosed w/ Anaphylaxis from adverse reaction to vaccine. She discharged and sent home to FU w/PCP. Her appt w/ her PCP on 3/25/2021 she was taken next door by wheelchair to all allergist Dr. She noticed that her respiratory symptoms were improving while she was there as her Pepcid medication was wearing off. Pt is convinced that she is allergic to the ingredient Polyethylene Glycol. She is still taking prednisone medication and continuing to improve.
55 2021-03-26 inability to speak POSSIBLE ANAPHYLAXIS, DIFFICULTY SWALLOWING, BREATHING, THEN SPEAKING. 911 CALLED. TRANSPORTED VIA E... Read more
POSSIBLE ANAPHYLAXIS, DIFFICULTY SWALLOWING, BREATHING, THEN SPEAKING. 911 CALLED. TRANSPORTED VIA EMS
55 2021-03-26 difficulty speaking Hoarseness, trouble swollowing. Sudden hypertension about 35 minutes after vaccine. Immediate metal... Read more
Hoarseness, trouble swollowing. Sudden hypertension about 35 minutes after vaccine. Immediate metal taste at time of vaccine.
55 2021-03-26 flushing 0810- C/O FAST HEART RATE, FLUSHING, FEELING, LAST 3-5 MIN. 0815 S/S EXCEPT A HEADACHE IN TH BACK O... Read more
0810- C/O FAST HEART RATE, FLUSHING, FEELING, LAST 3-5 MIN. 0815 S/S EXCEPT A HEADACHE IN TH BACK OF THE HEAD. PT STATED A HISTORY OF GETTING H/A. MONITORING V.S. WATER OFFERED REFUSED HAD BREAKFAST. 0810-02 SAT 99% 0812 HR 68 0815 BP 142/82-SAT 99% RR 20 HR 65 0824 99% RR 20 HR 67 0825 BP- 112/78 RR 16 Patient felt well enough to leave
55 2021-03-27 feeling cold From 3/22/21 through 3/26/21 (days 2 through 7 after the vaccine), I experienced: 1) my skin felt li... Read more
From 3/22/21 through 3/26/21 (days 2 through 7 after the vaccine), I experienced: 1) my skin felt like it was sunburned, I didn't have redness or a rash 2) I felt extremely cold, had to put on 4-5 layers including a down jacket inside the house, I never ran a fever 3) I had a headache, first on right side, then on upper left, then center of forehand, drinking 90 ounces or more of water a day helped 4) I had hyperosmia, a heightened sense of smell
55 2021-03-27 muscle spasms, migraine 3/27 Awoke at 1 am with muscle ache & cramps in legs. Shoulder was stiff., could not sleep due to p... Read more
3/27 Awoke at 1 am with muscle ache & cramps in legs. Shoulder was stiff., could not sleep due to pain. Around 5 am 101 fever, body aches, sick to stomach, migraine headache. 3/28 fever is gone , muscle pain gone, migraine more like a bad headache now..
55 2021-03-27 muscle spasms My reaction to the vaccine is the same way I felt when I had Covid back in December but with a new s... Read more
My reaction to the vaccine is the same way I felt when I had Covid back in December but with a new symptom. I am experiencing bad head aches, severe body aches, fever, nauseous,. This time with the vaccine I'm having severe spasms on my leg, arms and back to the point that I can't even touch it . I feel worse than I did when I was going through Covid. This is my 2nd day and I'm still feeling terrible.
55 2021-03-28 hot flush, pain in extremity upon injection felt the heat of medication 230 pm 3/25/2021 felt dizzy, with headache, and neck pain... Read more
upon injection felt the heat of medication 230 pm 3/25/2021 felt dizzy, with headache, and neck pain 600 pm 3/25/2021 swelling of arm, felt the heat on injection area, headache persistence, having heat flashes through the night & morning 9am 3/26/2021 headache comes and goes, arm still the same very sore, heat flashes persistence, dizziness, 3/27/2021 symptoms still all the same, seek medical attention from my primary doctor 3/28/2021 received prescriptions acetaminophen 500mg and meclizine
55 2021-03-29 weakness Besides the pain are soreness at the injection area I suffered from severe headache, extreme tiredne... Read more
Besides the pain are soreness at the injection area I suffered from severe headache, extreme tiredness and weakness for three days after first injection and for two days after second injection. Muscle ache in the upper abdominal area, both biceps and thighs on third day after second injection which only last 24 hours. I took Ibuprofen for the pain relief.
55 2021-03-29 weakness Since having the shot, I have noticed a great amount of swelling in my neck, even making it hard for... Read more
Since having the shot, I have noticed a great amount of swelling in my neck, even making it hard for me to breath at night when laying down to sleep. I also feel heart palpatations, even when laying down and it feels like irregular or racing heart rate, to the extent that I have to sit up and focus my mind on calming my heart rate. I also feel easily out of breath even in doing small activities. I have a lack of energy and I am sleeping a lot and still always feeling tired, I also have brain fog unless I drink a ton of coffee. I have no mental clarity for much of the day. I wonder if I will ever regain my full health prior to getting the shot. I also got really sick about 2 weeks after the shot with a really sore throat and chills and I didn't get better even when taking antibiotics. It's been a few weeks, and I am still not feeling normal.
55 2021-03-29 flushing Vaccine was administered during a drive through event. During the waiting period, she began to have... Read more
Vaccine was administered during a drive through event. During the waiting period, she began to have facial flushing. She was given benadryl 50mg po. Symptoms resolved and she was monitored for an extra period of time at the site. She was then dismissed to home with instructions to monitor carefully for additional symptoms and to seek medical attention immediately should these occur.
55 2021-03-29 flushing Patient reports that she received her first dose of the Pfizer Covid vaccine and within an hour deve... Read more
Patient reports that she received her first dose of the Pfizer Covid vaccine and within an hour developed flushing and diarrhea and states that her blood pressure was elevated 160/100. She states that flushing resolved after 24 hours but diarrhea has persisted to some degree.
55 2021-03-29 numbness, tingling C/o numbness, tingling in both arms ,face and feels warm all over. No swelling rash redness, flushin... Read more
C/o numbness, tingling in both arms ,face and feels warm all over. No swelling rash redness, flushing, SOB, chest pain or nausea. Pat feels nervous/ anxious. v/s HR 79, 119/77, 97% O2 RA. Pt felt s/s resolve and reported 126/79. No tingling after assessment . Refused transport.
55 2021-03-29 numbness Shortness of breath, chest pressure, dry mouth, numbness in hands.
55 2021-03-29 pain in extremity, facial pain, feeling hot A little over an hour after my shot I got extremely hot and started sweating for about an hour and a... Read more
A little over an hour after my shot I got extremely hot and started sweating for about an hour and a half. About four hours after the shot I got an extremely bad headache along with chills and very sore arm. Sometime shortly there after my neck on the left side felt sore and then my face on the left side felt sore. I had shooting pain in the right eye. The only thing that still hurts is my head and left side of my face.
55 2021-03-29 pain in extremity Light headed and dizzy , headache, body aches, chills, pain radiating from left shoulder to bottom o... Read more
Light headed and dizzy , headache, body aches, chills, pain radiating from left shoulder to bottom of left leg. Severe muscle aches. Fatigue, sleepy and foggy.
55 2021-03-29 tingling, muscle twitching feeling dizzy; tingling sensation and twitching sensation that comes and goes; tingling sensation an... Read more
feeling dizzy; tingling sensation and twitching sensation that comes and goes; tingling sensation and twitching sensation that comes and goes; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, lot number and Expiration date were not provided) on 04Mar2021 (also reported as 16 days ago) via unspecified route of administration at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021 (also reported as last night) the patient experienced feeling dizzy and a tingling sensation and twitching sensation that comes and goes. There was side effect mentioned. There was no PQC present. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
55 2021-03-29 tingling Pain in right arm began about 7 hours after injection. I slept on my left side all night because ri... Read more
Pain in right arm began about 7 hours after injection. I slept on my left side all night because right arm hurt. It especially hurts when I lift my arm. It also aches and tingles up and down entire arm and up through my neck, around to back shoulder blade and up through cheek. My ear is "congested" and hearing is impaired and my ear tingles also. I slept the entire night on my left side so it wouldn't be that fluid settled there over night.
55 2021-03-30 facial pain Significant pain following the trigeminal (CN5) nerve on right side (injection side); Jaw/tooth/gum/... Read more
Significant pain following the trigeminal (CN5) nerve on right side (injection side); Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; sensitive to pressure/heat/cold both upper and lower jaw; This is a spontaneous report from a 55-Year-Old non- pregnant female contactable Other Health Professional reported for herself that she received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 EUA, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 28Jan2021 (age at vaccination: 55 years) at 17:45 at single dose in right arm for covid-19 immunization. The patient's medical history included high cholesterol, Obesity, high blood pressure and known allergies: contrast dye. Concomitant medications included Simvastatin, Lisinopril, Aspirin 81, and Fish oil. On 28Jan2021 at 22:00, the patient experienced significant pain following the trigeminal (CN5) nerve on right side (injection side), Jaw/tooth/gum/cheek pain and sensitive to pressure/heat/cold both upper and lower jaw. The patient did not take any treatment for the events. The outcome of the events was not recovered Information on Lot/Batch number has been requested.
55 2021-03-30 hot flush, numbness, nerve pain, pain in extremity Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe nec... Read more
Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe neck pain; right cheek numb/sometimes left cheek numb feeling in lower cheeks/numbness in chin; hot flash in ears; chest pain; intense shoulder/shoulder pain/elbow pain; feels like it runs up the nerves; Pain in shot site left arm and pain in right arm in the same; severe headache/intense headache/pressure headache/bad headache; body pain at night; Pain in shot site left arm and pain in right arm in the same; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 55-years (non-pregnant at the time of vaccination), on 06Feb2021 at 01:45 PM at a single dose for COVID-19 immunisation. The patient's medical history included diabetes, high blood pressure, lacunar infarct, anemia, and non-rheumatic mitral regurgitation. The patient had no known allergies. Concomitant medications included losartan, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and acetaminophen. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. It was reported that Immediately after the shot, severe neck pain that wrapped up my face, right cheek numb, hot flash in ears, chest pain, intense shoulder, elbow pain, feels like it runs up the nerves, severe headache, ear pressure, lymph node swollen behind right ear on 06Feb2021 at 01:45 PM. Headache, body pain at night on 06Feb2021. O7Feb2021, numbness in right cheek, sometimes left cheek numb feeling in lower cheeks and intense headache. On 08Feb2021, ear pain, pressure headache, shoulder pain, cheeks numb left work early not feeling good at all headache very bad with acetaminophen (TYLENOL). Second vaccine shockingly painful side effects day of shot and days after. Pain in shot site left arm and pain in right arm in the same. Temp elevated night 100.9 F. On 09Feb2021, Off work vice grip headache, ear pain. On 10Feb2021, bad headache, numbness in cheeks remain, numbness in chin. The outcome of the events was recovering. It was also reported that post vaccination, the patient had not been tested for COVID.
55 2021-03-30 pain in extremity EUA - received injection at 9:50 am on 3/29/21. Started getting symptoms at 10:00 pm on 3/29/21, ... Read more
EUA - received injection at 9:50 am on 3/29/21. Started getting symptoms at 10:00 pm on 3/29/21, soreness in left arm, body started aching, chills with a fever of 103.3 for about 2 hours. (Tylenol was taken) was able to get temp down to 99.6. I took Zofran to prevent nausea . I also had a persistent headache for about 6 hours. All subsided by 10:00 am the following morning on 3/30/21. If I cough or sneeze my head hurts but other than that a mild headache.
55 2021-03-30 pain in extremity Head ache; arm pain; This is a spontaneous report from a contactable consumer or other non hcp (pati... Read more
Head ache; arm pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL92962, expiration date not reported), via an unspecified route of administration, administered on the left arm on 27Jan2021 12:15 (at the age of 55-years-old) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included levothyroxine (manufacturer unknown) taken for an unspecified indication. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered to the patient was at the Health Clinic. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced head ache and arm pain on 27Jan2021 16:45. Events were assessed as non-serious. Treatment was not received for the events.The outcome of events was recovering.
55 2021-03-30 pain in extremity Achy and chills, sore arm and neck
55 2021-03-30 tenderness I developed headaches; swelling of thyroid gland; tenderness; pain on swallowing; elevated TSH; low ... Read more
I developed headaches; swelling of thyroid gland; tenderness; pain on swallowing; elevated TSH; low T3,T4 levels; low T3,T4 levels; subacute thyroiditis; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELO142), via intramuscular route of administration on 23Dec2020 (age at vaccination: 55-years) at a single dose in the left arm for COVID-19 immunization. Medical history included Diabetes mellitus (DM) and Hypertension (HTN). Concomitant medications were not specified. The patient previously took codeine and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 27Dec2020, the patient developed headaches, swelling of thyroid gland, tenderness, pain on swallowing, elevated TSH, low T3,T4 levels. Patient thought to have subacute thyroiditis. The events resulted to physician office visit. The patient did not receive any treatment for the reported events. The patient underwent nasal swab test on an unspecified date and showed negative result. The outcome of the events was recovered on an unspecified date.
55 2021-03-31 weakness After vaccination, while waiting the recommended 15 minutes post vaccination, around 10 minutes, pat... Read more
After vaccination, while waiting the recommended 15 minutes post vaccination, around 10 minutes, patient fainted and eyes rolled back, patient was limb and could not stand. Patient was breathing and talking, however was disoriented, did not know where she was.
55 2021-03-31 cold sweat Patient felt clammy, sweaty, dizzy and nauseous post vaccination. Patient was laid down, given water... Read more
Patient felt clammy, sweaty, dizzy and nauseous post vaccination. Patient was laid down, given water and verbal support. Symptoms resolved with no issues. Patient was released @1030 after 30 minutes of observation.
55 2021-03-31 involuntary muscle movements, bell's palsy Bells Palsy Blurry sight-3/30/2021 Couldn?t move mouth-3/31/2021 Couldn?t close right eye- 4-1/2021
55 2021-03-31 difficulty speaking Patient received first Covid vaccine around 2:30pm. At 2:42 pm this nurse called out to patients ve... Read more
Patient received first Covid vaccine around 2:30pm. At 2:42 pm this nurse called out to patients vehicle who is c/o difficulty breathing. Patient reports her mouth feels like 'cotton mouth and tongue feels numb'. Patient appears to be very short of breath. Blood pressure 158/72. Pulse 78. At this time, patient reports she is having difficulty breathing and her throat is itchy and feels like it is closing up. Patients voice has changed. 2:45pm - called 911. 2:46pm - 0.5ml Epinephrine given IM left upper thigh. Lot 339384 Exp 8/21. 2:48pm - Patient continues to present with shortness of breath and still c/o throat tightness. Diphenhydramine 50mg given IM left deltoid. Lot 6020400 Exp 9/21. 2:51 pm- Patient reports she is starting to feel better and having a little easier time breathing. Fire dept with responders arrive. 2:57pm - Ambulance arrives and assesses patient. Patient refuses to go to ER. She reports she is feeling much better. She is requesting for brother to be called so he can drive her home. Brother called. 3:15 ambulance and fire dept left. This nurse stayed with patient until brother arrived. Patient left at 3:40pm in stable condition with brother driving patients vehicle.
55 2021-03-31 pain in extremity I woke up in the night feeling bad and tried to sleep through, My bladder hurt and I had to get up ... Read more
I woke up in the night feeling bad and tried to sleep through, My bladder hurt and I had to get up several times to use the bathroom. (like when I have had a bladder infection in the past. When I woke in the morning, I barely could walk downstairs. I spent the day on the couch sleeping. My temperature continued to rise and I finally took a Tylenol. A couple of hours later, I felt a little relief. I took a warm bath to relieve the muscle and joint aches. After sleeping through the night, I felt much better the next day. I am tired/sleepy today (April 1, 2021), but no fever and other significant symptoms. My symptoms March 31, 2021: Injection arm soreness, body aches, joints and muscles, fever 101, fatigue, sleepiness (slept all day - could not stay awake, headache, bladder irritability, chest hurt.
55 2021-04-01 fibromyalgia, facial paralysis, tingling, numbness her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; al... Read more
her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; allergic reaction to the COVID-19 Vaccine; heaviness with her headache; stroke; Facial droop; Numbness / left half of her face was numb /numbness in her left hand/numbness and tingling all over her body; Tingling; Tiredness; Pain; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old adult female received the first dose of BNT162b2 (solution for injection; Lot EN6202 and expiry information not provided) via unspecified route in the left arm on 03Mar2021 between 17:10 and 17:30 (at 55-years-old) for COVID-19 immunisation. Relevant medical history included Frozen shoulder (2020-2020), and severe migraines (especially in the past ten years). The patient further stated that she has always had migraines. She said sometimes when her migraines escalate, her blood pressure goes up, and her left side tingles. She said several times in the past, she thought her migraine symptoms may have been a stroke. She said she her doctor is checking her for any kind of things like rheumatoid arthritis, mast cells, constant (chronic) fatigue, and fibromyalgia. She said right before the COVID-19 Virus pandemic she had passed out unexpectedly. She said she doesn't know what caused her to pass out. She said she needs another neurological test done. She said she had a neurological test that maybe showed that veins were dying in her brain, but she wasn't sure. She said her doctor had been doing heart tests too, but because of the pandemic, it was taking longer to have the tests done. The patient also mentioned that her last blood work was probably in/around Nov2020. There were no concomitant medications or past drug history reported. The patient denied receiving any other vaccination within the four weeks prior to the vaccination. The patient also denied receiving any other vaccination on the same date as the vaccination. The patient reported that on 04Mar2021, approximately seventeen hours after she received the COVID-19 vaccine, she had what she thought was a kind of severe reaction. She said she had an inside numbness and tingling all over her body. She said the left side of her body, especially, had a very strong numbness and tingling, like a stroke. She said the numbness was in her left hand, and outside left shoulder. She said the left half of her face was numb. She said at the time she felt weird. She said she was speaking to her friend on a video call and did not want her friend to think she was a cry baby. She said then her friend told her there was something happening with her face. She said the right side of her face had dropped. She said her right eye and the right side of her mouth were drooping. She said she told her friend she thought she had an allergic reaction to the COVID-19 Vaccine. She said it took about three hours for her symptoms to pass. She said afterward she was so tired, had pain, and a headache. She said it was strange for her to have a headache because she was used to migraines. She said she still had a headache today (08Mar2021). She said she had a heaviness with her headache. She said if she had a migraine, she would not be able to do anything, but with the headache she had, she was able to go about her everyday things. She said her stomach was bothering her too, but she was not worried about how her stomach felt. The events did not require any visits to a physician's office nor the emergency room. Treatment for the events included drinking a lot of water and moving around. The outcome of the events, inside numbness and tingling all over her body, very strong numbness and tingling, like a stroke¸ numbness was in her left hand, and outside left shoulder, half of her face was numb, right side of her face had dropped, and tongue looked swollen, and allergic reaction to the COVID-19 Vaccine was recovered on 04Mar2021 after about three hours duration. The outcome of the events so tired, and pain was recovered on an unspecified date in Mar2021. The outcome of the events, headache, and heaviness with her headache was not recovered.
55 2021-04-01 flushing Pt reported itchy face at 2:24. Given PO Benadryl. Reported having similar reaction but delayed wi... Read more
Pt reported itchy face at 2:24. Given PO Benadryl. Reported having similar reaction but delayed with first dose. 2:46 reported dizziness. 3:09 reported feeling flushed in face but itching in face subsiding.
55 2021-04-01 numbness Numbing of lips, face, nose cavity. Thickening tongue. Weight on chest. Symptoms consistent with my ... Read more
Numbing of lips, face, nose cavity. Thickening tongue. Weight on chest. Symptoms consistent with my response to both ibuprofen and strawberry allergies except less severe and no hives. Lasted about 4-6 hours.
55 2021-04-01 tingling possible anaphylactic reaction vs. anxiety. HISTORY OF PRESENT ILLNESS: This is a 55-year-old brou... Read more
possible anaphylactic reaction vs. anxiety. HISTORY OF PRESENT ILLNESS: This is a 55-year-old brought by EMS from vaccine clinic after receiving the Pfizer COVID-19 vaccine. She reports having history of anaphylaxis to bee stings, most recently needing treatment about 2 summers ago. Today after the vaccination she began developed symptoms that were reminiscent to her of that. Soon after receiving it, she said she was feeling sweaty, starting to become out of breath, and felt like she had swelling developing in her throat. She noticed that she was breathing with some difficulty and started to feel tingling in her face hands and feet. She received an epinephrine intramuscular injection and soon after her symptoms started to improve. EMS responded within minutes and brought her to the emergency department for further evaluation. She did not have loss of consciousness. She did not develop hives. She had nausea but no vomiting or diarrhea. She reports that with her previous anaphylactic reaction to bee stings, she did not develop hives or GI symptoms, but felt like she was puffy all over and had airway symptoms. Today she and her husband do not think that she started to have a change in her voice, but she did think that her throat was starting to swell. After arrival in the emergency department, she said it was starting to feel a little bit harder to breathe again and that she is developing some central chest pressure. CHIEF COMPLAINT: POSSIBLE ALLERGIC REACTION Assessment/Plan DIAGNOSIS at time of disposition: 1. Vaccine reaction, initial encounter 2. Acute chest pain MEDICAL DECISION MAKING From the description of her symptoms it is unclear to me whether she truly had an anaphylactic reaction to the vaccination or whether she instead had an acute anxiety reaction associated with hyperventilating. The sense of tingling around the lips, hands, the along with her not having any change in the quality of her voice would tend to support this. However she notes that with previous bee sting systemic reactions she did not necessarily have a change in voice if she gave her epinephrine quickly enough and typically did not develop hives then either. To treat for the possibility anaphylaxis, I will also give her IV dexamethasone, IV diphenhydramine, IV famotidine. Given her complaint of some chest discomfort, we will check an EKG, troponin x2, chest x-ray. Given her history of diabetes and now having chest pain, I would have some degree of concern for ACS and will give her aspirin as we do the workup. Her most recent workup was July 1, 2019 when she had a nuclear medicine stress test, with normal results. She does seem to be hyperventilating and feels nervous, in addition we will give a dose of lorazepam. If her symptoms improve, and her troponin is negative, based on her story EKG believe her HEART score would be 2 due to underlying risk factors and that she would be appropriate for outpatient followup of the chest pain. From the reaction standpoint, if she is feeling well few hours later without any recurrence of symptoms, it would be reasonable to discharge her. At this point her x-ray and labs are pending and I will sign her over to the oncoming physician.
55 2021-04-01 tingling Today after the vaccination she began developed symptoms that were reminiscent to her of that. Soon... Read more
Today after the vaccination she began developed symptoms that were reminiscent to her of that. Soon after receiving it, she said she was feeling sweaty, starting to become out of breath, and felt like she had swelling developing in her throat. She noticed that she was breathing with some difficulty and started to feel tingling in her face hands and feet. She received an epinephrine intramuscular injection and soon after her symptoms started to improve. EMS responded within minutes and brought her to the emergency department for further evaluation. She did not have loss of consciousness. She did not develop hives. She had nausea but no vomiting or diarrhea. She reports that with her previous anaphylactic reaction to bee stings, she did not develop hives or GI symptoms, but felt like she was puffy all over and had airway symptoms. Today she and her husband do not think that she started to have a change in her voice, but she did think that her throat was starting to swell. After arrival in the emergency department, she said it was starting to feel a little bit harder to breathe again and that she is developing some central chest pressure. Pt was seen in the ED approx 35 minutes after receiving the vaccine. She was diagnosed with a vaccine reaction to COVID 19 vaccine and discharged home on prednisone 50 mg daily
55 2021-04-01 unresponsive to stimuli Patient became dizzy and nausea. Then patient blacked out and became unresponsive. EMS was called an... Read more
Patient became dizzy and nausea. Then patient blacked out and became unresponsive. EMS was called and patient became responsive and taken to ER
55 2021-04-02 feeling hot Member compliant of feeling hot, nausea. Radial pulse 120
55 2021-04-03 burning sensation Approximately 11 days after vaccination had burning feeling all over body (Similar to reaction of ta... Read more
Approximately 11 days after vaccination had burning feeling all over body (Similar to reaction of taking sulfa antibiotic). This continued for 5 or 6 days. I took Zyrtec and Benadryl for 5 days. Symptom stopped on April 1, 2021. On April 2, 2021 I was extremely dizzy, nauseous, severe headache, and heart palpitations. This continued all day. I contacted my physician and had an appointment. She instructed me to go to urgent care she was afraid I was having a stroke. I went to urgent care heart palpitations had stopped. My BP 128/75, Pulse 83, Oxygen 97%. They then performed a Rapid Covid test which came back inconclusive.
55 2021-04-03 numbness and pain in extremities For the first 12 hours - no effects at all. After then stiffness in arm near injection site, elevat... Read more
For the first 12 hours - no effects at all. After then stiffness in arm near injection site, elevation of blood sugar from my normal before bed reading of 160-180 up to 274. The next morning still high at 201. Also neuropathy (which I?ve never had) on the tops of both feet and ankles.
55 2021-04-04 grand mal seizure, tremor 4-3-21 APROX 11:15AM PT SHAKING, VERY ANXIOUS WITH REDNESS AND ITCHING ALL OVER - PT PLACED IN WHEEL... Read more
4-3-21 APROX 11:15AM PT SHAKING, VERY ANXIOUS WITH REDNESS AND ITCHING ALL OVER - PT PLACED IN WHEELCHAIR AND TAKEN TO MEDIC TENT PER, RN. PT STATES SHE HAD A RASH LAST TIME SO SHE TOOK BENADRYL AT 6:30AM AND 10:30AM TODAY (PT TOOK 2 MORE OF HER OWN BENADRYL AT 11:15AM). RAPID BREATHING, 'BAD HEADACHE'. SQUAD CALLED FOR TRANSPORT. PT W/D. HUSBAND AT HER SIDE. COMFORT GIVEN. 11:27AM TO ER PER SQUAD, HUSBAND TO FOLLOW IN AUTO. 4-5-21 11:23AM TC: PT STATES SHE HAD A 'GRAND MAL SEIZURE IN THE SQUAD'. THEY TOLD HER SHE HAD LACTIC ACIDOSIS, ELEVATED POTASSIUM AND WAS DEHYDRATED. 'CT WAS NEG.' STATES HIVES/RASH IS GONE TODAY.
55 2021-04-04 nerve pain, pain in extremity I experienced a sore arm and felt very tired for two days following the vaccination. A few days aft... Read more
I experienced a sore arm and felt very tired for two days following the vaccination. A few days after I started to feel nerve and muscle pain on my right shoulder blade. The pain did not go away and I started to feel nerve and itching on my chest on the right side and light red rash appeared on my back and chest. On March 27th the rash blistered and had spread and I began having intense pain. I was diagnosed with Shingles on March 30 and have been taking Valacylovir for 6 days. It has now crusted over and the pain is much less severe. Three days ago I got a sore throat and bladder pain. Those appear to be better so I have chosen not to seek treatment .
55 2021-04-04 tremor violent shaking, fever 103, loss of consciousness
55 2021-04-05 feeling of insects crawling on skin Pt had covid vaccine #2 at approx 9 am. Within 10 min had roof of mouth swelling and skin crawling,... Read more
Pt had covid vaccine #2 at approx 9 am. Within 10 min had roof of mouth swelling and skin crawling, ear itching. No airway compromise. Declined epi pen administration Benadryl given at 932 Sx began resolving within 10 min. OBJECTIVE: Alert nad 125/82 95% 16 pulse 94 Initially sl flushed no hives. Op clear Voice indicated soft tissue swelling No respiratory distress. CV: Regular rate and rhythm, no murmurs. Pulm: Bilaterally CTA no wheezing. repeat vitals at 950 119/71/88/98% By 10:20 sx improving 119/71/, 88, sat 98% By 1030 near complete resolution of symptoms, throat swelling improved, minimal itching. Repeat prior to discharge at 101/66 80, 98% 1045 pm Epi pen ordered for emergency use, Husband picking up at clinic.
55 2021-04-05 hot flush hot flashes, tightness on left arm, headache, funny feeling, resolved.
55 2021-04-05 numbness, tingling Ongoing Tingling,numbness in hands and fingers then moved to right side of my face.Ongoing ringing i... Read more
Ongoing Tingling,numbness in hands and fingers then moved to right side of my face.Ongoing ringing in my ears!
55 2021-04-05 numbness PATIENT COMPLAINED OF NUMBNESS TO BILATERAL LOWER EXTREMITIES AND BILATERAL UPPER EXTREMITIES. PATI... Read more
PATIENT COMPLAINED OF NUMBNESS TO BILATERAL LOWER EXTREMITIES AND BILATERAL UPPER EXTREMITIES. PATIENT DENIES SOB AT THIS TIME. DR. RECOMMENDED TO TAKE 50 MG OF BENADRYL , PATIENT TOOK MEDICATION P.O.
55 2021-04-05 pain in extremity, limb paralysis Had developed symptoms 24 hours afetr, extreme fatigue, chills, fever, unable to move legs this last... Read more
Had developed symptoms 24 hours afetr, extreme fatigue, chills, fever, unable to move legs this lasted 3 and a half days. 3/ 28 was in bed all day, arm pain and lymphnodes were swollen under arms.
55 2021-04-05 pain in extremity Covid Vaccine: First: 3/11/21 (lot # EN6203 - LD) Second dose: 4/1/21 (lot # EN6208 -LD) Patient re... Read more
Covid Vaccine: First: 3/11/21 (lot # EN6203 - LD) Second dose: 4/1/21 (lot # EN6208 -LD) Patient received her second dose vaccine on Thursday 4/1. On Friday 4/2 she started to develop sore arm and lightheaded sensation. When she checked her blood pressure, her systolic was in the 80s. Patient was presented to ED for checkup.
55 2021-04-05 pain in extremity sore arm, stuffy nose, achy 4/2 - sore arm, stuffy nose, bloody nose, achy 4/3 - sore arm, stuffy no... Read more
sore arm, stuffy nose, achy 4/2 - sore arm, stuffy nose, bloody nose, achy 4/3 - sore arm, stuffy nose, headache, achy 4/4 - stuffy nose, headache, achy 4/5- work up congestion, stuffy nose, slightly achy but better than previous days, slight headache
55 2021-04-05 tenderness A severe headache in the first hour followed by fatigue an hour later. Muscle aches and low grade f... Read more
A severe headache in the first hour followed by fatigue an hour later. Muscle aches and low grade fever in the evening. The next day I has a lot more fatigue and general muscle pain. I also developed irritable bowels and a loss of appetite. The left arm became very painful to the touch and while moving it. Low grade fever continued. The second day was much of the same but a new symptom which was concerning. Chest pain near breast and rib in the left side. The pains were shooting and intermittent. More fatigue and continued stomach issues and lack of appetite. Day 3 I felt greater fatigue and muscle pain but the arm pain bd headache were better. I took the day to rest mostly. Day 4 (today) I fully expected to feel better but I felt the same and took the day off work to rest. Low grade fever fatigue and muscle pains. Stomach issues turned to diarrhea today. Headache returned for a while but chest pains better. For the record I?ve never experienced adverse reactions to any vaccine. I?m also very healthy and active running hiking and biking 20 miles a day.
55 2021-04-05 tremor "watery eyes, racing heart beat, shaky"
55 2021-04-06 numbness Numbness on the right side of the face after 8 minutes. it lasted for 10 minutes before it subsided ... Read more
Numbness on the right side of the face after 8 minutes. it lasted for 10 minutes before it subsided and then it happened again ten minutes later. I have felt the after effects on the side of my face since then. My teeth hurt and after effects of numbness. Also, 102 temp two days after injection and very painful arm on the injection side.
55 2021-04-06 numbness Pt. Received second covid-19 vaccine today. After 15 minutes she reported numbness to her left side ... Read more
Pt. Received second covid-19 vaccine today. After 15 minutes she reported numbness to her left side of face. Also a mild headache and dizziness. She is alert and oriented times four and equal good strength to arms and legs bilaterally. No facial droop noted. Vital signs at this time (13:23): BP: 138/83, HR: 75, O2:98%.She denies any medical history or allergies at this time. Benadryl not given due to no ride. Provider was called and given report. She advised to do a stroke assessment and call 911. Vitals at this time (13:36): BP: 165/85, HR:72, O2: 99%. LVN called 911 and gave report. Advised by 911 to not provide food or liquids. As paramedics pulled up, Pt. Complained of difficulty swallowing. Vitals at this time (13:40): BP:130/49, HR: 72, O2:99%. Paramedics took over scene, assessed Pt. And advised her to go to the hospital. Then transported Pt. To nearest hospital.
55 2021-04-06 night sweats, feeling jittery, hot flush, tension headache, tingling INITIALLY FEVER, ACHES, HEADACHES,HOT FLUSHES, NAUSEA, DIARRHEA, AND UPPER ABDOMINAL STOMACH PAIN WI... Read more
INITIALLY FEVER, ACHES, HEADACHES,HOT FLUSHES, NAUSEA, DIARRHEA, AND UPPER ABDOMINAL STOMACH PAIN WITH DIGESTIVE COMPACITIY DIMINISHED. LASTED ABOUT 1 WEEK, THEN FOR ADDITIONAL 10 DAYS AND STILL CONTINUING, I HAVE HAD HOT FLASHES, TINGINLING IN MY HEAD WITH TIGHTNESS, INCREASE HEART RATE, AND BLOOD PRESSURE, AND WAKING UP EVERY NIGHT AT 3 AM IN THE MORNING WITH BAD NIGHT SWEATS MOST OF THE TIME. NONE OF THIS EXISTED BEFORE THE SECOND PFIZER VACCINE. I AM 55 AND IN MENOPAUSE , BUT WAS TOTALLY CONTROLLED WITH NATURAL PROGESTERONE SUPPLEMENTATION. THE WORST IS THE RACY HEART, AND JITTERINESS , WITH HEADACHES.
55 2021-04-06 pain in extremity could hardly breathe; Dizzy; Throat started to close; Headache; allergic reaction; pain in thighs; T... Read more
could hardly breathe; Dizzy; Throat started to close; Headache; allergic reaction; pain in thighs; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EP6955, expiry date: Jul2021, NDC number: 59267-1000-02), via an unspecified route of administration, administered in Arm Left on 19Mar2021 09:00 AM (received at the age of 55-year-old) as single dose for COVID-19 immunization. Medical history included hypertension from Jan2015. Concomitant medication included ascorbic acid (VIT C, 1000 mg tablet) for immunity (help with the immune system to help fight against cold and those things), from Apr2020; fish oil (OMEGA 3 FISH OILS, 500 mg Capsule) for heart health, from 2019; vitamin d nos (VITAMIN D NOS, Gel) for immunity (help with the immune system to help fight against cold and those things), from Apr2020; tocopherol, ubidecarenone (COQ-10 ST, 200 mg Gel) taken to help with energy and cardiovascular health, from Apr2020; amlodipine (AMLODIPINE, 5 mg) taken for hypertension, from 2016; hydrochlorothiazide (HYDROCHLORZIDE, 12.5 mg) taken for hypertension, from 2017. The patient experienced could hardly breathe, dizzy, throat started to close, headache, allergic reaction on 19Mar2021. The patient stated that she took Pfizer covid vaccine first dose last Friday (19Mar2021) and ended up in the hospital. After taking the COVID Vaccine, she immediately had symptoms that started with being dizzy and her throat stated to close. She ended up with a headache. She also had to appoint because it was pretty consistent and pretty high, so she ended up at an ER. She added that her throat was closing, she could hardly breathe. She was able to walk and talk fine before the vaccine, she stated after the vaccine she ended up in the ER (emergency room). The patient did not stay in the ER overnight; alternatively, it was reported that patient was hospitalized for 5 hours (from 19Mar2021 to 19Mar2021). They checked all of her vitals as well as blood work and everything (19Mar2021). They only thing they came up with was that she had allergic reaction. She said she is doing better now. As corrective treatment, she took Benadryl 25 mg. The patient said she also noticed pain her thighs (Mar2021). Outcome of the event pain in thighs was unknown, while the outcome of the remaining events was recovering. She wanted to know about any program to investigate it or to assist with hospital bill.
55 2021-04-06 pain in extremity I began developing pain in my left leg Friday, March 19th - two days after receiving my second injec... Read more
I began developing pain in my left leg Friday, March 19th - two days after receiving my second injection. My early Monday morning I was in so much pain that I went to the ER. I was diagnosed with acute DVT in my entire left leg from the Iliac vein in my abdomen down to the ankle. The entire leg was occluded.
55 2021-04-06 pain in extremity Redness and swelling in the vaccine area. Arm pain and swollen glands
55 2021-04-06 tingling, numbness, nerve pain Tingling, rapid fire sharp nerve pain, numbness through out body.
55 2021-04-06 tremor At 1045am, c/o tingling in lips and mouth. Gave Benadryl 25mg PO at 1048am and contacted Dr. Started... Read more
At 1045am, c/o tingling in lips and mouth. Gave Benadryl 25mg PO at 1048am and contacted Dr. Started shaking at 1050am. At 1100am, no tingling in lips. At 1110am, shaking stopped. At 1116, c/o tingling in throat and right hand swelling. EMS called to assess. At 1120am, monitored by EMS. At 1140am, left site feeling better. Instructed not to schedule second dose at drive through setting and to contact PCP for further recommendations. Instructed to take another Benadryl at home or go to ER for any further reactions. Also instructed to keep Epi-Pen at all times.
55 2021-04-07 weakness Itching on front bend of elbow, last 24 hours feeling low on energy & wanting to sleep all the time.
55 2021-04-07 burning sensation Patient reports stinging sensation to L neck after injection in L deltoid. Denies SOB. Patient give... Read more
Patient reports stinging sensation to L neck after injection in L deltoid. Denies SOB. Patient given bendadryl 50mg PO at 0838. 0844 - Patient reports burning sensation has improved. 0848 - BP = 143/89, HR = 104, RR = 18 and O2 Sat = 100%. Redness decreasing - patient reports no burning or itching. Patient advised to ask her physician if she should take benadryl prior to 2nd dose.
55 2021-04-07 feeling hot Person felt warm, had sneezing and rhinorrhea approximately 20 min after.
55 2021-04-07 numbness 3/28/21, 9:35 a.m. received Pfizer shot. 28 mins after receiving shot in my right arm, my forehead ... Read more
3/28/21, 9:35 a.m. received Pfizer shot. 28 mins after receiving shot in my right arm, my forehead and cheek bones started to feel numb. Shortly after, my whole left arm (opposite arm where I had shot) all the way to my fingertips, extending to my left part of my chest, had a very strong sensation, numbing. I told the EMT's on site and was watched. That lasted 12 mins. Once it subsided, we left ,thinking it was done. Throughout the rest of the day, I felt waves of a "spacey" feeling, walked with a wide gait feeling "out of wack", and this would occur every 10-15 mins. 3/28/21 4:00 p.m.went emergency room when my left arm again, went numb. It extended from my left elbow down and worked its way up my arm after extending to the left side of my upper back. This occurrence was a little less intense than the first, but very worrisome. Also, my right arm had the same reaction this time, only on a lesser intensity than my left arm. After it resolved, both thumbs remained tingling. Went to ER.
55 2021-04-07 tingling, numbness numbness and tingling in lower extremities and achy bones Patient tool Tylenol with some relief, rec... Read more
numbness and tingling in lower extremities and achy bones Patient tool Tylenol with some relief, recommended to continue taking Tylenol as directed, drink plenty of fluids, rest and elevate legs. Advised if symptoms worsen contact MD.
55 2021-04-07 tenderness large red bump on arm near vaccination, sensitive, swollen, sore to touch achy left arm and underarm
55 2021-04-07 tremor, muscle spasms At 1pm the next day Fatigue, light headache. Then at 9pm extreme abdominal pain with diarrhea follow... Read more
At 1pm the next day Fatigue, light headache. Then at 9pm extreme abdominal pain with diarrhea followed by uncontrollable shaking that my muscles were starting to have spasms. After 20 minutes all subsided.
55 2021-04-07 tremor Shakey and cold, reports having anxiety. 1:15 PSO2 98% pulse 70 Respirations even and unlabored. N... Read more
Shakey and cold, reports having anxiety. 1:15 PSO2 98% pulse 70 Respirations even and unlabored. No sign or symptom of ditress. Continued to monitor. 1:26 Pso2 99% pusle 65 continued to monitor. 1:38 client decided she was okay to leave still cold and shakey. Informed she could stay longer to be monitored. Decided she would leave and try to warm up in her car. Was informed to seek medical attention if any other problems. Given V-safe information for follow up.
55 2021-04-08 weakness Vice-like headache, shooting pain in neck and upper back, sensitivity to light, exhaustion, tinnitus... Read more
Vice-like headache, shooting pain in neck and upper back, sensitivity to light, exhaustion, tinnitus, low appetite, back pain shifted to sacrum and hamstrings second day, painful to sit, stand, walk, put on socks, difficult to concentrate, unable to work for nearly 2 weeks, still extremely low energy.
55 2021-04-08 numbness 1/20 vaccination 30 Minutes later, my tongue started to go numb. Within 15 min, from eyebrow down to... Read more
1/20 vaccination 30 Minutes later, my tongue started to go numb. Within 15 min, from eyebrow down to my neck was completely numb on L side. Lasted for 2 weeks. I called back to facility and they said they had never heard about it. Then thru the weekend, I recorded everything on an app and did telehealth with PCM. By 3-4 days later before 2nd vaccination, it got better. 2nd vaccination, little numbness, fatigue, tightness across chest. No course of treatment advised by PCM but faired better with second vaccination; 2/10/2021.
55 2021-04-08 muscle spasms On 3/19/20 approx 2:30 pm Pfizer COVID vaccination. Felt fine, no obvious side effects On 3/20/21, ... Read more
On 3/19/20 approx 2:30 pm Pfizer COVID vaccination. Felt fine, no obvious side effects On 3/20/21, late afternoon, the following adverse reactions occurred: Back pain & spasms Right knee swollen and sore Shoulder, clavicle, trapezius pain Shoulder/Clavicle Pain: Sharp pain started in left shoulder joint, then moved a little further in to settle underneath my clavicle. Pain exactly like after abdominal surgery when they insufflate you with Co2 and your body develops that horrible, sharp pain under your collar bone and in your shoulder joint as you off-gas. From 3/20 to 3/27, the shoulder joint/clavicle pain was mild to moderate, becoming more intense when I lay down. It kept moving up and down specific spots in my shoulder area, from the shoulder joint to the base of my neck and back again, not spread out through the whole shoulder area. Shoulder pain level 1-4, so nothing compared to the level 8 of my back. The shoulder pain was the least of my worries in comparison at the time. It seemed to be getting milder as my back pain subsided At 12:30 am on 3/28, I woke with excruciating stabbing pain in the middle of my left shoulder area, specifically halfway between my neck and my shoulder joint. Pain level 8. The pain gets worse when I inhale. The pain moves from the middle of my shoulder/clavicle area to the base of my neck, and back to the shoulder joint. It continues to travel up and down my shoulder area and makes it very hard to breathe as it?s so painful to inhale at 7:30 am on 3/28, the pain started snaking down the front of my chest towards my heart and up my neck into the left side of my head. I now have a mild pulsing headache on the left and sharp stabbing pain in my heart area and down the ribs on that side, as well as the sharp pain in the middle of my shoulder/trapezius area. The left side of my head feels heavy Using my left arm and lifting my head from the pillow intensifies the pain. Inhaling, Leaning forward to put on socks, leaning forward to clean the litter box, hiccuping, burping, going to the bathroom??..anything that requires abdominal pressure or pressure to the top of my body, like leaning over, intensifies the pain incredibly. . 9:30 3/28 ? pain has settled in mid clavicle region and has dropped to pain level 6 3/29 ? pain pretty much the same as on 3/28. I was able to get some sleep by sitting up in my recliner?.lying down increases the pressure in my shoulder/clavicle region, thus intensifying the pain incredibly so I can?t inhale without intense pain and can?t sleep. Cleaning the litter box, putting on shoes or socks, going #2, hiccuping, taking a deep breath?..all cause incredible sharp pain at mid clavicle?.level 8. Lying down brings the pain to the front of the clavicle, sitting upright or standing moves the pain more towards my trapezius. I want to make clear this is not a muscle pain?.I haven?t strained or sprained any muscle and this is not that. I?m not sure what this is?..possibly a nerve pain? Feels exactly like off-gassing from Co2 insufflation, only more intense. Something to do with my abdomen? 3/30 ? pain seems to be a little less intense. Still had to sleep with my upper body elevated last night, but I was able to sleep. 3/30 ? 10:15 pain is less?.I?m able to inhale at level 5 instead of 8. 3/31 ? Pain much less, level 3 overall and staying put at center clavicle 4/1 ? 10:15 Sudden, Sharp, stabbing pain moved from center clavicle to shoulder joint and then moved down my left side and over into my abdomen below my ribcage. Worse on left side, but reaching across mid abdomen and mildly into the right side. Level 6 11:15 pain in abdomen subsiding, shoulder joint pain level 3 4/2-4/7 ? clavicle/shoulder pain improved each day, fluctuating between pain level 1-3. 4/8 ? clavicle/shoulder pain has almost resolved itself. Pain level 0-1 Back Pain: On 3/20 - lower back sudden excruciating pain, radiated to right hip on Sunday, then switched to left hip on Monday and Tuesday. Also right groin painful. Pain level 7 Tuesday night 3-23 ? pain moved from lower back to mid back with bad spasms. Pain level 8. Fever 99.9. pain also in left groin & lower abdomen today. Weds morning 3-24 ? pain has lessened in mid back somewhat, but is much worse on right side center back. Still having spasms. Pain level 7, 8 when I engage back muscles at all. Leaning forward, sitting, standing, and wiping extremely painful. It?s slightly better when lying down or in anti-gravity chair. Fever 99.9. pain has also moved to under my ribs on right front and more into my abdominals. Thursday morning 3-25 ? pain has lessened somewhat overall, but has spread more fully across my mid back, so both sides of my mid back are painful. Sharp pain in right side isn?t as bad, but now I have a sharp pain snaking down from mid back toward lower along the right side spine. Fever has broken. Pain level 6-7. Groin and abdominal pain much less 3/25 ? Saw my Spine Dr. She agrees that this is an adverse reaction to the Covid vaccination. Prescribed muscle relaxers to help with spasms. Evening 3/25 ? pain horrible across my mid back, wrapping around my rib cage, snaking down along my spine. Pain Level 8 3/26 ? pain and spasms bad upon awaking, but began to subside mid morning. Pain level reduced from 8 to 5 over the course of the day. By evening, pain level reduced to 4 and stabbing pains almost gone when moving and breathing. 3/27 ? mid back, ribcage, groin and abdominal pain almost gone, pain level 3. Lumbar region pain my ?normal? 3-4 pain level. Lumbar pain improves with rest. By evening, all pain except lumbar down to level 1-2. Lumbar level 3 3/28 - mid back, ribcage, groin and abdominal pain almost gone, pain level 1-2. Lumbar region pain my ?normal? 3 pain level. Lumbar pain improves with rest. 3/29 ? shoulder/ clavicle/trap pain level 8 starting at 12:30 am Knee Pain: Right knee swelled up and painful Knee stays moderately swollen, stiff and painful throughout this ordeal from 3/20-3/28 so far. Pain level 3 My knee replacement recovery was going great prior to this. I had minimal swelling and pain until 3/20 3/30 ? knee still stiff, but not as swollen. Pain 3 3/31 ? 4/8 ? knee swelling and pain still present, but has been slowly improving each day. I?m continuing to do my knee rehab exercises and ride my recumbent bike.
55 2021-04-08 pain in extremity Sore arm, hip and calf left side. Lump under left arm. Fever, nausea, metallic taste, chills, wors... Read more
Sore arm, hip and calf left side. Lump under left arm. Fever, nausea, metallic taste, chills, worse than when I had covid
55 2021-04-08 tremor AT 10:45 AM PT C/O TINGLING IN LIPS AND MOUTH. GAVE PT BENADRYL 25MG PO AT 10:48 AM AND CONTACTED DR... Read more
AT 10:45 AM PT C/O TINGLING IN LIPS AND MOUTH. GAVE PT BENADRYL 25MG PO AT 10:48 AM AND CONTACTED DR. WAITED WITH PT EXTRA TIME. PT HAD STARTED SHAKING AT 10:50 AM. AT 11:00 AM LIPS NOT TINGLING. AT 11:10 AM, STOPPED SHAKING. AT 11:16 AM C/O TINGLING IN THROAT AND RIGHT HAND SWELLING. EMS CALLED TO ASSESS. AT 11:20AM PT BEING MONITORED BY EMS. AT 11:40 AM PT LEFT SITE, FEELING BETTER. PT TOLD NOT TO SCHEDULE 2ND DOSE AT ANY DRIVE THRU SETTING.
55 2021-04-09 weakness Pfizer BioNTech Covid-19 Vaccine EUA After the second shot, I had a fever, very weak. The highest t... Read more
Pfizer BioNTech Covid-19 Vaccine EUA After the second shot, I had a fever, very weak. The highest the fever got up to was 101.5. Took Tylenol every 4 hours. Lasted about a day.
55 2021-04-09 migraine, facial pain, muscle spasms, difficulty speaking, pain in extremity 4-5-21 at 6:00 p.m.: stiff neck, fatigue 4-6-21 at 2:00 a.m.: Migraine, stiff neck, pain in right... Read more
4-5-21 at 6:00 p.m.: stiff neck, fatigue 4-6-21 at 2:00 a.m.: Migraine, stiff neck, pain in right cheekbone, leg cramps, pain in arm 4-6 thru 4-7: Fever, migraine, muscle cramps, throbbing pain in legs and hips, unable to lift left arm, fatigue, chills, nasuea, cold sores and mouth liasons (on pallate and bottom gum, left side, hoarse voice 4-7 thru 4-9: Only Hoarse voice, cold sores and mouth liasons 4-10: Only cold sores and mouth liasons remain
55 2021-04-09 pain in extremity Tired, headache, high fever 104.6 Arm sore back sore, coughing labored breathing
55 2021-04-09 tingling, pain in extremity First dose Back pain for three weeks. Second dose back pain. Sever joint Pain, stiffness and cracki... Read more
First dose Back pain for three weeks. Second dose back pain. Sever joint Pain, stiffness and cracking. Pain to put pressure feet and hands. Warm feeling in hands and feet. When the aching went away started severe throbbing pain hands and feet. Overall warm feverish feeling in body. Facial tingling feeling off and on. After three weeks from second shot I went to my GP. She did bloodwork and put me on oral steroids for three days to try to ease pain in joints. Bloodwork was fine. GP believes I have ongoing reaction to vaccine
55 2021-04-09 tingling Pt c/o pinprick with tingling and dizziness briefly after receiving vaccine. No SOB. Denies LOC. VS ... Read more
Pt c/o pinprick with tingling and dizziness briefly after receiving vaccine. No SOB. Denies LOC. VS at 1523: BP 149/81, HR 86, RR 17, O2 sat 100% on RA. VS at 1540: BP 128/90, HR 90, RR 16, O2 sat 98% on RA. VSS at time of discharge. No s/s of distress noted. Pt refused w/c to exit.
55 2021-04-10 discomfort 55yo F reported immediate mid back pain, non-radiating and stabbing in nature. Denied history of sim... Read more
55yo F reported immediate mid back pain, non-radiating and stabbing in nature. Denied history of similar pain or back injuries. Pt was evaluated by medical staff and ems. She was midly hypertensive to 150s systolic that improved after 30min. Pt was unable to find a position of comfort and reported waxing and waving of pain while be observed. Pt was released with instructions on nsaid use, heat therapy, stretching, and return precautions.
55 2021-04-10 muscle spasms Pfizer-BioNTech Covid-19 Vaccine Numbing on my entire right arm and swelling. then soon after I fel... Read more
Pfizer-BioNTech Covid-19 Vaccine Numbing on my entire right arm and swelling. then soon after I felt my throat closing and my tongue swelling. I couldn't even swallow my saliva. There was tingling in my lips and tongue too. Also felt like spasms inside my right arm. For 3 hours I was very scared then little by little there was improvement. Next morning my throat has improved but my arm is the same and I have a headache all over.
55 2021-04-10 tingling The first thing I noticed was occasional tingling in my left hand on April 9. On April 10 a little ... Read more
The first thing I noticed was occasional tingling in my left hand on April 9. On April 10 a little more frequent and almost like it was "going to sleep" slightly. Today, April 11, more of the same but also in my arm. I am also having some stiffness on the back side of my neck, occassionaly that I have had in the past at times. Today, I have also noticed the left side of my tongue feeling a slight tingling.
55 2021-04-10 tremor Passed out got hives blood pressure went through the roof gave chewable benadryl started shaking cou... Read more
Passed out got hives blood pressure went through the roof gave chewable benadryl started shaking could not control then ticket in thought next thing in ambulance and very hard to breath gave me shots ephedrine and steroids calmed a bit but came back at hospital gave albuterol HFA 108. Left 6 hours later with albuterol HFA 108 and 3 days of predniSONE 10 MG tablet. went my doctor next day put me on 10 of predniSONEcetirizine 10 MG tablet and clartoncetirizine 10 MG tablet at night and clarton in morning continue hydroCHLOROthiazide 25 MG
55 2021-04-11 bell's palsy metal test in mouth 30 minutes after injection Bells Palsy set in on 3/23 (6 days after injection
55 2021-04-11 facial paralysis Right lower lip numbness and drooping x 2 days.
55 2021-04-11 flushing Flushing/sweating, dizziness. BP 106/64, HR64, RR 16, given juice and monitored, patient left in sta... Read more
Flushing/sweating, dizziness. BP 106/64, HR64, RR 16, given juice and monitored, patient left in stable condition
55 2021-04-11 flushing Severe dry coughing, throat felt like it was closing -which it was, flushed and body aches. Almost ... Read more
Severe dry coughing, throat felt like it was closing -which it was, flushed and body aches. Almost had to use Epi Pen but, immediately took three regular Benadryl, which helped with swollen throat. Lasted app. one hour until the Benadryl started working. Dry cough remained.
55 2021-04-11 muscle spasms Severe headache and neck pain particularly in the anterior neck with redness and burning of anterior... Read more
Severe headache and neck pain particularly in the anterior neck with redness and burning of anterior neck chest and ears. Also on anterior neck a feeling of terrible tightness and muscle spasm like head wants to pull down. Under chin and sides of tounge hot red burning sensation. Much worse after I take my thyroid medicine in the morning. I have called my doctor and am awaiting a call back if it gets worse I will go to urgent care.
55 2021-04-11 pain in extremity Patient experienced dizziness, headache, nausea and arm tenderness about 5 minutes after receiving ... Read more
Patient experienced dizziness, headache, nausea and arm tenderness about 5 minutes after receiving her 1st dose. Within 45 minutes that patient was noted to be "flushed." She laid down, was given water and oral Benadryl.
55 2021-04-11 pain in extremity Very sore arm fir 24 hours . 99.9 fever and chills. Very fatigued for 24 hours, beginning , 39 hours... Read more
Very sore arm fir 24 hours . 99.9 fever and chills. Very fatigued for 24 hours, beginning , 39 hours after receiving injection.
55 2021-04-11 pain in extremity The nurse said I had to stay for 30 minutes. At 15 minutes, they made us leave. My reaction happened... Read more
The nurse said I had to stay for 30 minutes. At 15 minutes, they made us leave. My reaction happened at 20 minutes while we were on our way home. I got sick to my stomach. Then my cheeks swelled up. I had some troubles breathing. The next day, my arm was swollen and painful, and I ached all over and was tired.
55 2021-04-12 weakness Patient called stating that she started experiencing muscle weakness in her arms, legs, and back abo... Read more
Patient called stating that she started experiencing muscle weakness in her arms, legs, and back about 3 days after getting her first COVID vaccine. She reports that she has had difficulty walking and it became so bad that she went to the emergency room. She also reports she had the normal side effects of vomiting, diarrhea, and body aches.
55 2021-04-12 slurring, bell's palsy All was fine till day 9 evening when my right eye kept watering, and I brushed my teeth water shot o... Read more
All was fine till day 9 evening when my right eye kept watering, and I brushed my teeth water shot out right side. Next day same thing with blurred speech. I went to hospital, had CT n MRI. No blood clot determined its bells palsy. I have been healthy accept for mild seasonal allergies
55 2021-04-12 flushing, tingling within 5 minutes of receiving injection felt it move through body and felt flushed, an EMT took my ... Read more
within 5 minutes of receiving injection felt it move through body and felt flushed, an EMT took my bp = 165/107 and hr =117, felt super hot in gland areas, tingling in left jaw and tongue, flash headaches, light sensitivity, muffled hearing, itching skin, skin crawling (tingling) all over. Was given total of 75mg Benadryl along with 40mg Pepcid Remained at the clinic for almost 2 hours, symptoms persisted from day of injection Thursday March 25 - Monday March 29
55 2021-04-12 migraine, numbness, tremor Headache. Chills/shaking. Numbness on the right side of the head and face. Discomfort in the right a... Read more
Headache. Chills/shaking. Numbness on the right side of the head and face. Discomfort in the right arm and foot. Vision blurred in both eyes but stronger in the right. Dry right eye and difficulty having movement and blinking. On Thursday 4-01-2021 more acute symptoms, headache and severe chest pain as a consequence I had to go to the emergency room. And to this day my symptoms continue.
55 2021-04-12 muscle spasms, weakness Brain fog and drowsiness 5 minutes after receiving vaccine, slight headache, fatigued later. Within ... Read more
Brain fog and drowsiness 5 minutes after receiving vaccine, slight headache, fatigued later. Within the week, neck out of alignment (went to chiropractor), felt neck/head pulsing, felt like a muscle contraction, vascular issues, hard to breathe, hypoxia. For the first two weeks, legs felt like they had blocks on them, had to get a massage from massage therapist. Lacks energy
55 2021-04-12 pain in extremity Started Levocetirizine 5mg q24hrs 2 days prior to vaccine. Approximately 20-25min after receiving th... Read more
Started Levocetirizine 5mg q24hrs 2 days prior to vaccine. Approximately 20-25min after receiving the vaccine developed an acute headache (top of head) and tingling/ fuzzy feel to tongue. Tongue appeared visibly more pale than normal and possibly slightly swollen. Symptoms lasted 2-4hrs (gradually improved over that time frame). Breathing/ heart rate normal during the entire time. Burnt tongue feeling lasted for 5-7 days (only noted intermittently over last 2 days). Soreness to arm noted next day (mild) and resolved after 48hrs. Started taper Prednisone dose after reaction x 10 days. No further reactions noted.
55 2021-04-12 tingling Pt developed facial tingling, throat tightness and anxiety. She mentioned that she may be having anx... Read more
Pt developed facial tingling, throat tightness and anxiety. She mentioned that she may be having anxiety issues. BP 200/120, HR 80 and SP02 98%. 911/EMS evaluation and transport to ER recommended. Pt declined and is aware of the risks of leaving AMA. She improved without intervention. Family picked her up and she departed at 735pm.
55 2021-04-12 tingling After receiving my 2nd Pfizer COVID vaccine, I have been experiencing severe neck pain and tingling ... Read more
After receiving my 2nd Pfizer COVID vaccine, I have been experiencing severe neck pain and tingling in my arm, shoulder, and neck on the side where I was given the vaccine. I have been taking Aleve muscle and back pain twice a day every day since March 29, 2021, and that really is not helping. The pain seems to be lessening, but it is beyond difficult to sleep, and being able to concentrate through the pain while working is difficult as well.
55 2021-04-12 seizure like phenomena, pain in extremity When she was able to fall asleep she woke biting my tongue like a seizure; Severe left arm and shoul... Read more
When she was able to fall asleep she woke biting my tongue like a seizure; Severe left arm and shoulder pain; Severe left arm and shoulder pain; Fever that gradually went higher to 103.7; Severe headache; Jaw pain; Blurred vision; Tired; Sweaty; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:00 as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Sulfa's and sulfurs, Unknown blood clotting disorder, Arnold chiari malformation syndrome, sinusitis. Concomitant medication included apixaban (ELIQUIS) taken for Unknown blood clotting disorder. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6199) on 06Mar2021, 04:00AM on left arm for covid-19 immunisation (55 years old). On 28Mar2021, 04:00, the patient stated that she had severe left arm and shoulder pain, fever that gradually went higher to 103.7 then a day later the fever went down. Severe headache with jaw pain, blurred vision. When she was able to fall asleep she woke biting my tongue like a seizure. Currently she is tired and sweaty, fever has gone, arm pain gone within a day and a half. Therapeutic measures were taken as a result of all the events included At home pain and fever medicine. The patient was not pregnant. Outcome of the events pain in arm and fever was recovered on an unspecified date while outcome of the remaining events was recovering.
55 2021-04-13 weakness Extreme fatigue, low energy, unable to complete physical tasks as I was able too prior to receiving ... Read more
Extreme fatigue, low energy, unable to complete physical tasks as I was able too prior to receiving the COVID19 shot.
55 2021-04-13 burning sensation red spots under my eyes, it started with only itchiness now I can see the spots and burn a tiny tiny... Read more
red spots under my eyes, it started with only itchiness now I can see the spots and burn a tiny tiny bit. have tried all kinds of creams and my dr told me to talk Benadryl which I have done for 1 day. I have it on both eyes, not a lot but enough that is visible
55 2021-04-13 slurring That evening after getting 2nd shot I was rushed to ER because I has slurred speech- I went to ER an... Read more
That evening after getting 2nd shot I was rushed to ER because I has slurred speech- I went to ER and they initially thought I had bells palsy, but after a CT to confirm they found a brain bleed and I was rushed to hospital and put in the ICU and after two MRI's they also found a stroke - I had several tests and stayed in ICU for 5 days they could never determine the cause of the brain bleed or stroke - all tests were negative for autoimmune diseases.
55 2021-04-13 facial paralysis, inability to speak The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her ri... Read more
The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her right eye that never went away. Then on Wednesday morning, March 31st (two weeks after receiving the first dose), she was found in bed by my mother, unable to walk or talk, her face was drooping, she was very sweaty, and had defecated on herself. My mother called the ambulance. She was transported to Hospital where it was determined she had suffered a massive hemorrhagic stroke. She was immediately transported by ambulance to another Hospital. She spent one day in ICU and then was put on palliative care. She died around 12/N on Friday, April 2nd, two days after the stroke.
55 2021-04-13 tingling, numbness patient reports numbness, tingling or left upper arm and perioral numbness/tingling about 5 mins aft... Read more
patient reports numbness, tingling or left upper arm and perioral numbness/tingling about 5 mins after vaccination. Benadryl given and symptoms resolved by 2:08pm
55 2021-04-14 cold sweat Had a reaction 25 minutes after receiving the vaccine. swelling tongue, hands and feet. Dizzy, nause... Read more
Had a reaction 25 minutes after receiving the vaccine. swelling tongue, hands and feet. Dizzy, nausea, felt like I was going to throw up. Cold sweat. Lasted for about 25 minutes. Felt okay the next two days, then starting Friday 4/9 the dizzy and nausea came back. Tightness in chest and so dizzy having trouble working a full day at work. Some times it would go away and I would feel fine, then it would come back. I haven't had one day where I have felt good the whole day since.
55 2021-04-14 discomfort, pain in extremity When I woke up the day after receiving the vaccine my armpit on the left (side I received the vaccin... Read more
When I woke up the day after receiving the vaccine my armpit on the left (side I received the vaccine) and the underside of my arm heading towards my elbow (but not all the way to the elbow) was in excruciating pain. The pain kept me up til 5am the following day and this continued for 5 nights. I treated it with frozen vegetable packs under my arm. Very very painful. I have had surgical procedures and take ZERO painkillers......have a high threshold for pain, and I'm telling you this was bad....very uncomfortable.
55 2021-04-14 numbness About 25 minutes after injection I felt a pain and then numbness that claimed my neck into my jaw, c... Read more
About 25 minutes after injection I felt a pain and then numbness that claimed my neck into my jaw, cheek, nose, eye area, and forehead accompanied by a metal taste in my mouth. All occurred on the left side only. It is now 4:25 and I still have the same numbness. So far, other observations are soreness of muscle in upper left arm and stiffness in left side of neck. My husband was also vaccinated at the same time in a different pharmacy and is experiencing similar side effects with numbness is mouth/jaw and metal taste.
55 2021-04-14 migraine Had extreme migraine that led to extreme vomiting
55 2021-04-14 pain in extremity, tingling 18 days after shot I am still having arm pain. It has gotten worse since the onset. There is pain ... Read more
18 days after shot I am still having arm pain. It has gotten worse since the onset. There is pain in arm that is now migrated to my shoulder and neck. My grip strength is weak due to pain in forearm. I have tingling from elbow into my hand.
55 2021-04-14 pain in extremity Sore arm 3 days. Fatigue - 2 weeks. Headache - few days.
55 2021-04-14 tingling, burning sensation, numbness my whole left side went completely numb and had burning sensation from my head to my toes. was very... Read more
my whole left side went completely numb and had burning sensation from my head to my toes. was very server for about 6 hours. Still have tingling definitely not like it was in some areas on the left side 5 days later.
55 2021-04-14 tingling Started with dizziness, then nausea, tingling sensation, lump in throat. Then racing heart and heart... Read more
Started with dizziness, then nausea, tingling sensation, lump in throat. Then racing heart and heart palpitations. Blood pressure dangerously high. Then extreme tiredness and passed out. Then ambulance was called
55 2021-04-14 tenderness Felt dizzy for the first week ( lightheaded ) , chills without a fever . One week later SEVERE pain ... Read more
Felt dizzy for the first week ( lightheaded ) , chills without a fever . One week later SEVERE pain in my middle back radiating through to the front and around the side ( unable to be touched ) .. Feels like shingles pain...no rash
55 2021-04-15 pain in extremity sore arm,fatigue,swollen lymph nodes and constant and on going headaches at least 3 to 4 times daily... Read more
sore arm,fatigue,swollen lymph nodes and constant and on going headaches at least 3 to 4 times daily.
55 2021-04-15 pain in extremity Left arm still hurts three weeks later to move or use that arm
55 2021-04-15 tingling fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial ... Read more
fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial tingling/bilateral hand and foot tingling; double vision; disorientation; joint pain; orthostatic hypotension; chills; photophobic/photophobia; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left deltoid on 26Jan2021 15:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The first dose was received on 05Jan2021 15:00 (lot number: EL1284) on the left arm. Medical history included herpes simplex virus (HSV), Superior Oblique Myokymia, and Lyme Disease; from an unspecified date and unknown if ongoing. Patient was not pregnant. Concomitant medications included calcium citrate, magnesium citrate (CAL/MAG CITRATE), ergocalciferol (VIT D), fish oil (OMEGA 3), and paracetamol (TYLENOL). The patient previously took VICODIN and flu vaccine as a child, and experienced allergies. The patient experienced headache, nausea, dizziness, facial tingling, double vision, disorientation, joint pain, orthostatic hypotension, chills, photophobic from 27Jan2021 05:00. On 02Feb2021, she experienced dizziness, headache, nausea, photophobia, facial tingling, bilateral hand and foot tingling, GFR 47 all other CBC, cmp normal. There was headache, nausea, photophobia, facial tingling on 07Feb2021 and on 10Feb2021, tingling and fatigue from waist to feet posteriorly and bilaterally. She had lab test drawn and blood work done when she was sick and her GFR came back as 47, so everything else was normal, and her GFR was 47 which was out of range. On 03Feb2021 was the first test and it was 2 weeks that she had to repeat test just to make sure it was back in normal range which it was. Thee patient was still experiencing the events but 'not as bad', and stated she can still function. Her side effects were improving but she still have a daily headache and paresthesia. The events resulted in physician/ healthcare professional visit. Patient was recovering from the events. ZOFRAN was given as treatment for the events. Patient stated she takes Tylenol but her doctor want her not to take medication for a while but she had to take Tylenol. Patient had no covid prior to vaccination and has been tested (nasal swab) post vaccination on 29Jan2021 with negative results.
55 2021-04-15 tenderness Patient received dose of vaccine on 4/7/21. Patient noted area of blanchable redness on 4/16/21 abou... Read more
Patient received dose of vaccine on 4/7/21. Patient noted area of blanchable redness on 4/16/21 about 2 inches distal to the vaccine site. Area of redness is 3.5 cm x 4.5 cm. Slight swelling, tender to touch, and slight itching. No drainage, opening of the skin, or flaking. Unclear if related to vaccine, but given uncertain etiology and proximity to site of injection reporting as possible adverse reaction. Plan for patient is to currently monitor, and advise office with new or worsening symptoms.
55 2021-04-15 tremor 102.8 fever, diarrhea, shaking, nausea, body aches, fast pulse, high blood pressure.
55 2021-04-16 feeling hot, facial pain The face felt hot, felt tiredness, chills, pain and redness of the face. Benadryl was taken.
55 2021-04-16 fibromyalgia Fibromyalgia flare up. I am still in pain 5 weeks later. Taking anti inflammatory meds and physical ... Read more
Fibromyalgia flare up. I am still in pain 5 weeks later. Taking anti inflammatory meds and physical therapy. Not helping.
55 2021-04-16 migraine Body aches, severe neck stiffness, migraine and fever of 101°
55 2021-04-16 pain in extremity Vaccine at 1115a. Hydrated after the vaccine a lot. Was fine most of the day and evening, except f... Read more
Vaccine at 1115a. Hydrated after the vaccine a lot. Was fine most of the day and evening, except for increasing soreness of arm at injection site. Woke up at 2a with headache, then sleepless most of the night. Sore arm. Headache and general feeling of nausea thru mid afternoon, 2p. Sensitive skin, occasional slight chills. Headache turned very severe mid afternoon. Fever of 101. Took 2 Excedrin around 530p, used ice pack on head and neck. Felt slightly better around 7p and was able to eat some food. Noticed swelling under my arms that evening, particularly left arm. Headache mostly gone by 930p. Slept 9 1/2 hours. Seem recovered, except for sore arm and continued lymph node swelling.
55 2021-04-16 pain in extremity 1 hour after receiving the shot, I started to breakout in a widespread rash with hives and inflammat... Read more
1 hour after receiving the shot, I started to breakout in a widespread rash with hives and inflammation. I also had muscle soreness in my left arm and shoulders. Muscle soreness lasted a few days. I took benadryl and zrtec for the rash and hives. The rash disappeared after 3-4 days, but the hives continued for about a week. The itching lasted 11 days.
55 2021-04-16 pain in extremity Nausea, headache, pain of the left arm, pain of the left leg (behind the knee), Severe itchy rash on... Read more
Nausea, headache, pain of the left arm, pain of the left leg (behind the knee), Severe itchy rash on arms, legs, belly and face , blisters.
55 2021-04-16 cold extremities, feeling hot At 1045 pt c/o she is "very hot", upon assessment the pt's skin is cold and diaphoretic. The pt is a... Read more
At 1045 pt c/o she is "very hot", upon assessment the pt's skin is cold and diaphoretic. The pt is also not very verbal at this time. At 1048 the pt's vitals are: HR 50 bpm (per monitor), O2 98%RA (per monitor), and BP was unable to be determined per monitor x3. At 1053 the pt's vitals are: BP 78/46 (pre monitor), HR 88, Resp 16, & O2 99%RA, per monitor. At 1103, the pt's vitals are: BP 97/65 (per monitor), HR 76, Resp 20, & O2 100%RA per monitor. At 1108, the pt's vitals are: BP 91/61 (per monitor), HR 78, Resp 20, & O2 100%RA per monitor. At 1110 Northstar arrived, pt transported to DCH RMC ED at this time. Pt in stable condition upon departure.
55 2021-04-17 numbness My Ulcerative Colitis flared up 2 weeks after I got my second dose of the vaccine on January 29th, 2... Read more
My Ulcerative Colitis flared up 2 weeks after I got my second dose of the vaccine on January 29th, 2021. And I have had to re-start on medication after being in remission for 2 years. Then since April 12th, I have began to have daily spells of dizziness, numbness, tiredness and feeling like I'm having a stroke. I would feel better after I take a couple of aspirins and Tylenols two or three times day. I am getting ready to go to the ER after I turn in this report because I do not know if i will get better.
55 2021-04-17 pain in extremity Very sore arm, tiredness, sudden vaginal bleeding during menopause; Very sore arm, tiredness, sudden... Read more
Very sore arm, tiredness, sudden vaginal bleeding during menopause; Very sore arm, tiredness, sudden vaginal bleeding during menopause; Very sore arm, tiredness, sudden vaginal bleeding during menopause; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 (Lot Number: EW 0150) at single dose for covid-19 immunization. Medical history included chronic pain from old injury. No known allergies. The patient didn't have Covid prior vaccination. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; hydromorphone 2 mg taken for an unspecified indication, start and stop date were not reported; tramadol ER 200 mg taken for an unspecified indication, start and stop date were not reported. No other vaccines in four weeks. The patient previously received the first dose of bnt162b2 (Lot number: EN6207) in left arm on 12Mar2021 at 55 years old for covid-19 immunization. The patient experienced very sore arm, tiredness, sudden vaginal bleeding during menopause on 01Apr2021 05:00 PM. No treatment was received for the events. Covid was not tested post vaccination. The outcome of the events was unknown.
55 2021-04-18 breast pain, pain in extremity I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt ... Read more
I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt a lot of fatigue; a lot of arm pain; I felt some mild dizziness later in the day; irritable bowels throughout the day as well as a loss of appetite./My appetite is very much diminished; irritable bowels throughout the day as well as a loss of appetite.; I also started experiencing an odd ribcage/breast pain on the side of the injection (left side).; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (Patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EW0150), via an unspecified route of administration in the left arm on 02Apr2021 (age at time of vaccination: 55-years-old) at a single dose for COVID-19 immunization. Medical history included asthma, allergies to medications, food, or other products as Tree Nuts and NSAIDS. Concomitant medication patient received within 2 weeks of vaccination included zyrtec, vitamins C, Vitamin D, Vitamin E, Probiotic and Tylenol. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient experienced about 90 mins after 1 vaccine dose on 02Apr2021 at 04:00 PM, she developed a strong headache. The patient then felt very fatigued and came down with fever that night. The next day (yesterday), the headache was improved still present but she felt a lot of fatigue and a lot of arm pain. She felt some mild dizziness later in the day and irritable bowels throughout the day as well as a loss of appetite. On 02Apr2021, a day after 2 vaccine dose, she again felt fatigued with mild headache. her appetite was very much diminished with still irritable bowels. She also started experiencing an odd ribcage or breast pain on the side of the injection, it was felt like deep shooting pains. There was no pain or redness or swelling. she not breast issues to date (last mammography was clear-Fall 2018). Facility where the most recent COVID-19 vaccine was administered was Clinic. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal swab was unknown on 02Apr2021. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
55 2021-04-18 breast pain Within 15 minutes of the injection, I developed moderate tenderness in the injection site in my righ... Read more
Within 15 minutes of the injection, I developed moderate tenderness in the injection site in my right arm muscle area. I also developed at the same time moderate pain and tenderness in my right breast between my arm pit and the right side of my right breast. The breast tenderness continued from 15 minutes post injection on Monday 4-12 until Saturday 4-17, 2021. On the morning following my first injection of Pfizer Covid-19 vaccine, approximately 24 hours post injection, I developed red, itchy blotches over my face. I also developed hot, deep red itchy skin on BOTH arms, from mid upper arm continuously to the tops of my hands. Both palms were also red and itchy. BOTH kneecaps were itchy and red. BOTH feet were itchy and red on the tops and bottoms. Symptoms continued for approximately two and a half hours before dissipating. At this point I called the hospital for guidance regarding my reactions to the vaccine.
55 2021-04-18 pain in extremity, weakness Weakness, dizziness, fatigue, sore arm
55 2021-04-18 pain in extremity Nausea, headache, sore arm, aches, chills, low-grade fever, sore throat
55 2021-04-18 pain in extremity 4/15/2021 Evening: Dry mouth, sore arm 4/16/2021 By 8am: Headache, stiff joint, temp 99.5F 4/16/20... Read more
4/15/2021 Evening: Dry mouth, sore arm 4/16/2021 By 8am: Headache, stiff joint, temp 99.5F 4/16/2021 Throughout the day, headache and temp ranging 99.5F to 100F 4/16/2021 6:30 pm: Took Tylenol 4/16/2021 By 7 pm, the headache is gone 4/16/2021 By 8pm, temp 97.2F, still higher than normal temp (below 96.8F) 4/17/2021 9am. Temp 98.1F. Sharp sting in right eye, mild sting in left eye. They went away after 5 mins or so. Eyes felt heavy through out the day. 4/19/2021 3pm. Tinnitus. Usually it is unnoticeable, but it's very loud. It comes and goes, but this is the worst tinnitus I have experienced.
55 2021-04-18 cold extremities, feeling cold I received my vaccine in my right arm. I never felt the injection as it was being administered, nor ... Read more
I received my vaccine in my right arm. I never felt the injection as it was being administered, nor was my arm initially sore. I remained in observation for 15 minutes with no problems noted. I got in my car, and 20 minutes later, I noticed my hand feeling very cold. I touched both hands to my cheeks to measure temperature variation. It was very cold. The cold sensation traveled up my arm to my deltoid muscle. I got home at 07:45 PM. My husband used his infrared thermometer to measure the temperature difference. My right hand/fingers were several degrees colder. The cold sensation is constant. No real alleviating or exacerbating factors. It feels internally like my hand is in ICE. Hard to use hand at times.
55 2021-04-19 weakness, feeling cold, hot flush Severe stomach cramps, severe diarrhea, feverish, nauseated, weak, started Saturday night okay Sund... Read more
Severe stomach cramps, severe diarrhea, feverish, nauseated, weak, started Saturday night okay Sunday Monday, Tuesday morning severe stomach cramping, stabbing pain, severe diarrhea, hot cold flashes, very nauseated unable to eat. Sips of water.
55 2021-04-19 difficulty speaking pt developed hoarseness in throat just after she left the parking area outside the clinic. she retu... Read more
pt developed hoarseness in throat just after she left the parking area outside the clinic. she returned to the clinic and received benadryl. she felt better and went home.
55 2021-04-19 feeling hot I received the covid vaccine at 1:30pm. That same night while lying in bed, I had a sudden sharp pai... Read more
I received the covid vaccine at 1:30pm. That same night while lying in bed, I had a sudden sharp pain in my right ankle. It felt like a vein exploded. It was warm and red the next day. I followed up with my primary nurse practitioner, who sent me to have a duplex ultrasound. There were no clots.
55 2021-04-19 tingling 3:40pm received shot. 3:45pm started feeling severe tingling in both wrists thru hand thru finger t... Read more
3:40pm received shot. 3:45pm started feeling severe tingling in both wrists thru hand thru finger tip s, and from knees to toes. Also mild nausea for 10 minutes. Tingling for 15 minutes. Almost hyperventilating for 5 minutes. Could not move or bend left thumb for 10 minutes. Fingers wanted to curl towards palm for 10 minutes. Symptoms went away after 15 minutes, no help given. I sipped water a few times during reactions. We left the building and the fresh air helped feel better. Able to drive home. No one checked on us while reaction occurred.
55 2021-04-19 tremor, hot flush, feeling cold Within a minute...Hot/cold flashes... Room fuzzy..felt light headed...heart started racing...trembli... Read more
Within a minute...Hot/cold flashes... Room fuzzy..felt light headed...heart started racing...trembling. About 1 hr later chest felt like someone was sitting on it...hard to breathe. Was down for two weeks.
55 2021-04-20 feeling hot Pt stated after her first Pfizer dose she did not have any adverse reactions that she could remember... Read more
Pt stated after her first Pfizer dose she did not have any adverse reactions that she could remember. Pt. was feeling normal prior to vaccination and stated she had a granola bar and some water for breakfast. Pt was sitting in chair when she alerted technicians about her symptoms. Pt. then stated she began to feel dizzy and lightheaded while sitting in the chair. When asked, pt. said her vision was clear and normal. Pt. has Hx of DM type II, HTN, seasonal allergies and asthma. We assisted pt. to floor in semi fowlers position with a pillow behind her head in position of comfort. I asked pt. if anyone was with her and she stated someone had dropped her off, but was alone currently. Pt. was alert and oriented to person, place and time. I asked if she would like us to call the squad and she responded yes. We called emergency personnel. Pt. was warm to touch, but was complaining of chills. Pulse was 88 bpm, respirations 14. Per pt. she has an allergy to lisinopril and is currently taking several prescription medications, but could not recall any names. Pt. began to notice some wheezing and I asked if she had an inhaler for her asthma. She self-administered 2 puffs of Ventolin which helped with her breathing symptoms. EMS arrived on scene and a brief Hx was given to the squad. EMS took vitals and loaded pt. on cot and transported to Hospital.
55 2021-04-20 pain in extremity, weakness Extreme symptoms for a full week after 1st Pfizer vaccine. Extremely painful muscle aches everywhere... Read more
Extreme symptoms for a full week after 1st Pfizer vaccine. Extremely painful muscle aches everywhere but worse in my legs. Constant nausea, could not taste or smell food, watery diarrhea, profound weakness, extreme fatigue, nightmares.
55 2021-04-20 pain in extremity Fully anticoagulated pt on Eliquis 5 po bid with 100% medication compliance admitted on 4/20/21 with... Read more
Fully anticoagulated pt on Eliquis 5 po bid with 100% medication compliance admitted on 4/20/21 with left arm pain. U/s demonstrated left brachial vein acute thrombus. U/s read by radiology from still frames only. I reviewed the u/s with the radiologist and it strongly suggests presence of left brachial vein thrombus. Pt offered endovascular treatment and taken to the cath lab on 4/21/21 in pm. U/s in the cath lab in my presence demonstrated no evidence of thrombus. NO symptoms of PE. Pt discharged home the same evening on eliquis 10 bid for 2 weeks. NO previous hematology evaluation to my knowledge despite h/o recurrent DVT/PE ~ 5 years ago.
55 2021-04-20 tingling, weakness 1st injection - 25 minutes afterwards I experienced a slightly heavy sensation - like a drop in pre... Read more
1st injection - 25 minutes afterwards I experienced a slightly heavy sensation - like a drop in pressure in the head, chest, and stomach. 5 minutes later, I experienced multiple tiny sharp pains in left calve and foot and same in right side of head, They were mildly painful, pins and needles and it was scary with regard to wondering if it was a stroke. Then 15 minutes later, I experienced random skin itching in different spots. The neurological attacks continued and came on randomly in short attacks in mostly the extremities, but sometimes the face. The facial skin seemed also to have swollen and aged very rapidly after 1st shot, Also, blurred vision. 2nd injection, 4 weeks later, no immediate response but 11 hours later neuro and vascular symptoms began to come on. in left foot and right arm. pins and needles and neuropathic itch in left foot. 8 hours following, full on fever and weakness and severe flu symptoms, Weak and disoriented and sweats and chills with fever in mornings of 102 or greater. Heavy chest and head congestion, dizziness, rigidity, inability to function - quite sick for days.
55 2021-04-21 migraine Extreme nausea Unbearable migraine Foggy brain
55 2021-04-21 pain in extremity diarrhea, chills, fever, headache, tiredness, muscle pain, and sore arm.
55 2021-04-21 tremor Dizziness and nausea, followed by full body tremors and uncontrollable shaking. This continued for 3... Read more
Dizziness and nausea, followed by full body tremors and uncontrollable shaking. This continued for 30 minutes and I decided to go to the ER. I continued to have dizziness and nausea and also minor tremors for two hours. I was observed at the ER and given Zofran to relieve the nausea. They performed an EKG and it was normal. I was released from the hospital after three hours of observation. I continued to have bouts of dizziness , mild tremors, and a left-side headache the remainder of the day. I continued to rest at home and my symptoms seemed greatly diminished on the morning of 04/22/2021. Experienced very mild bouts of dizziness and tremors in the morning, but as of 06:00pm on the 22nd, all symptoms are gone.
55 2021-04-22 pain in extremity Patient received second dose of Pfizer on 3/30/21. On 3/31/21 patient states arm was itchy , red, an... Read more
Patient received second dose of Pfizer on 3/30/21. On 3/31/21 patient states arm was itchy , red, and swollen. She is still having arm pain and continues to itch 3 weeks later.
55 2021-04-22 speech disorder Presented to ED with a chief complaint of throat swelling, difficulty speaking. Patient reports sign... Read more
Presented to ED with a chief complaint of throat swelling, difficulty speaking. Patient reports significant history of anaphylaxis. Intramuscular epinephrine, IV fluids, IV Benadryl, IV Pepcid ordered. In addition, p.o. prednisone ordered. Discharged in improved condition.
55 2021-04-23 migraine, bell's palsy, facial paralysis, numbness pain behind both ears, migraine, nauseousness, facial numbness and paralysis
55 2021-04-23 migraine TIREDNESS, HEADACHE (MIGRAINE),, MUSCLE PAIN, CHILLS - SEVERE, JOINT PAIN, NAUSEA, FEELING UNWELL, S... Read more
TIREDNESS, HEADACHE (MIGRAINE),, MUSCLE PAIN, CHILLS - SEVERE, JOINT PAIN, NAUSEA, FEELING UNWELL, SWOLLEN LYMPH NODES (LEFT ARM ONLY)
55 2021-04-23 pain in extremity Salvage vaccine was given greater than 6 hours after reconstituted. The patient was contacted and wi... Read more
Salvage vaccine was given greater than 6 hours after reconstituted. The patient was contacted and will follow up with her doctor. Patient experienced sore arm and shoulder. She also experienced swelling of her hands
55 2021-04-23 tingling, numbness After I had left the pharmacy my neck became tingly and numb and trouble swallowing but could contin... Read more
After I had left the pharmacy my neck became tingly and numb and trouble swallowing but could continue to breath through my nose. Did not go the hospital. It passed after perhaps 30 minutes. I talked with a doctor and will follow the cdc guidelines and get the JandJ shot now since it?s been after 28 days. Had a similar but milder experience after my hep shot 6 years ago. Just didn?t think about it since I wanted a vaccine.
55 2021-04-23 tingling, numbness Patient stated that she started experiencing numbness and tingling in her left middle finger and rin... Read more
Patient stated that she started experiencing numbness and tingling in her left middle finger and ring finger after receiving her vaccine. She was received in the Medication Observation Unit 1 and made comfortable on the stretcher. Patient vital signs were checked and neurological examinations were performed. Patient stated a relief in symptoms after 30 minutes of observation. Vitals sign were stable and patient was released at 1719. At 1740, patient came back to us and reported tightness in the chest and pain at her back. She was made comfortable in bed but refused for her vital signs to be checked including seeking immediate medical assistance. she insisted that, she is not in any position to visit ER at this time but will rather watch over her symptoms and report to the ER if it persists. She was released at 1745
55 2021-04-23 tingling Painful/heavy arm of injection site. Headache,unable to turn neck for period of time. Chills, low gr... Read more
Painful/heavy arm of injection site. Headache,unable to turn neck for period of time. Chills, low grade fever. Felt like prickly pins thru-out whole body/nerves. Nauseous, but didn?t get sick, only felt like it.
55 2021-04-23 tremor, hot flush, feeling cold Intense heat through body after vaccine Tremors, borderline convulsions Fever 103 Blacked out 24 hrs... Read more
Intense heat through body after vaccine Tremors, borderline convulsions Fever 103 Blacked out 24 hrs after vaccine Headache Tylenol could not relieve Body pain especially in legs and back Unable to lay down Shaking chills lasting 36 hrs Burning sensation in right eye Nausea Stomach cramps
55 2021-04-24 discomfort, pain in extremity It is not comfortable. It goes under arm all the way under her boob and down her side. It is not com... Read more
It is not comfortable. It goes under arm all the way under her boob and down her side. It is not comfortable and cannot rest; It is not comfortable and cannot rest; Pain and Soreness in left shoulder; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Right arm swollen/arm was swelling/right arm is swollen underneath and on top; her arm was swelling and really hurting; has not been able to sleep in about 2 days because of this; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0150) intramuscularly in left arm on 01Apr2021 10:00 at single dose for COVID-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: diabetes diagnosed 3-4 years ago, blood pressure abnormal, and hiatal hernia. She has to take Prilosec for a hiatal hernia but has been taking it for years. Concomitant medications included omeprazole magnesium (PRILOSEC) for hiatal hernia, and blood pressure medication and diabetes medication. She previously received the first dose of BNT162B2 on 04Mar2021 (Lot EN6202) in right arm in the muscle for COVID-19 immunisation. She took the second one on Thursday and it was not bothering her until Friday night until Saturday morning. On 03Apr2021 05:00, it woke her up and it felt like it went in the muscle under her arm. It was real sore like lymph nodes are sore and she cannot lift her arm. She got the second shot on Thursday morning and that is what caused it. Sometime toward daybreak on Saturday morning is when she first felt that her arm was swelling and really hurting on 03Apr2021 05:00. Her right arm is swollen underneath and on top. On 04Apr2021 08:00, pain in left shoulder is like when old people say they have pleurisy in the back. She has not been able to sleep in about 2 days (Apr2021) because of this. No ER or physician's office required. She felt like going but did not took Ibuprofen. She thought it was going to be great because she did not have any symptoms, but this has whooped her. It is not comfortable. It goes under arm all the way under her boob and down her side. It is not comfortable and cannot rest. She read over the paperwork and saw that there were Lymph nodes and she wanted to know if there was anything she can do for it. She is just taking blood pressure medication and diabetes medication and has been on them for several years. Event outcome of not comfortable and cannot rest, insomnia was unknown, while for others was not recovered.
55 2021-04-24 numbness Extreme face numbness lasted on whole face for 1 hour still have numbness around mouth
55 2021-04-24 muscle spasms, feeling of body temperature change, pain in extremity chills/intense shivering; nausea; vomiting; muscle cramps; exhaustion; heartburn/acid reflux even wi... Read more
chills/intense shivering; nausea; vomiting; muscle cramps; exhaustion; heartburn/acid reflux even with only water; heartburn/acid reflux even with only water; lack of appetite; Feeling hot and cold; mild sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 55-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 11:30 (lot number ER8752) on Left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Public Health Clinic/Veterans Administration facility. Medical history was reported as none. Concomitant medications included ibuprofen (ADVIL), cyclobenzaprine, guaifenesin, pseudoephedrine hydrochloride (SUDAFED). Historical Vaccine included first dose of BNT162B2 (lot number EN6208) on 12Mar2021 12:30 PM on Left arm for COVID-19 immunization. First night of second dose on 31Mar2021, the patient experienced mild sore arm. Morning after felt fine. First night was fine. 2nd night on 01Apr2021 the patient experienced chills, nausea, vomiting, muscle cramps and intense shivering. 3rd day and onward in Apr2021, the patient experienced exhaustion, muscle cramps, heartburn/acid reflux even with only water, lack of appetite, hot and cold flashes. No treatment was received for the adverse events. The outcome of event sore arm was resolved on 01Apr2021, outcome of other events were not resolved. No follow-up attempts are needed. No further information is expected.
55 2021-04-24 nerve pain, tremor headache; chin/head itches; left side face nerve pain; hand tremors; on edge emotionally; something ... Read more
headache; chin/head itches; left side face nerve pain; hand tremors; on edge emotionally; something is off neurologically--minor but enough for me to call in sick; This is a spontaneous report received from a contactable consumer (reporting on herself). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number: EN 6208 and Expiration Date was not re-ported), via an unspecified route of administration in in Arm Left on 24Mar2021 16:15 as single dose for COVID-19 immunization. Medical history included restless legs syndrome from an un-known date and unknown if ongoing. Concomitant medication(s) included carbidopa, levodopa (SINEMET); levothyroxine sodium (LEVOTHYROXIN) both taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes first dose of BNT162B2 on 03Mar2021 15:30 for COVID-19 immunization and patient experience minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips), exhaustion for four days, intense arm pain at injection site (pain began when shot was being given), slight nausea/light headed/dizzy on day 2. On 26Mar2021 at 06:00 patient after second shot of BNT162B2 patient experienced left side of face nerve pain (more than shot one), headache, chin/head itches, hand tremors, on edge emotionally (was fine yesterday), something is off neurologically minor but enough for me to call in sick, hope it is not another shingles outbreak. And saying hopefully in a few days this shall pass. The outcome of the events was unknown.
55 2021-04-24 tremor Diarrhea, rapid heart rate, tremors, anxiety, sweating, intolerance to warm weather. diagnosis of hy... Read more
Diarrhea, rapid heart rate, tremors, anxiety, sweating, intolerance to warm weather. diagnosis of hyperthyroidism.
55 2021-04-25 weakness In the morning on Saturday, April 24, woke up with general malaise, buzzing in both years, feeling n... Read more
In the morning on Saturday, April 24, woke up with general malaise, buzzing in both years, feeling nauseous, with headache, no apetite and difficulty drinking water. No energy, and every attempt to get up or sit up failed, after just a few minutes, I had to go back to laying down in a dark room most of the day. Unable to listen to radio or music, or watch anything on tv. No food intake, and less than 1 cup of water the whole day. On Sunday, able to rally in the afternoon, to eat a cup of soup, dring a cup of water, then had to lie down, unable to sit. In the evening, around 6 pm, able to force myself to get up and eat another cup of soup and some fruit. Able to drink a glass of water. Feeling better on Monday April 26. Symptoms subsiding, except for the buzzing in both ears. Constant buzzing in both ears, began after the first shot (EN6208), given on March 31, 2021, after the second shot is much louder and never stops. Buzzing is ongoing today (Monday April 26).
55 2021-04-25 difficulty speaking Patient received first dose of COVID-19 vaccine (Pfizer) on 4/16/21 on left arm. On day 2 after vacc... Read more
Patient received first dose of COVID-19 vaccine (Pfizer) on 4/16/21 on left arm. On day 2 after vaccination, +fatigue, headaches (though she had some headaches on and off even before the vaccination), some raspiness when talking (but no pain in the throat with swallowing). On day 3, patient had subjective fever (did not check temperature that day). Fatigue has still continued on until today. She is still having headaches on and off. Raspiness in throat is still present. Patient has had some difficulty falling asleep on about 5-6 nights since the vaccination. She has had this issue in the past as well on and off. Patient has also been taking more naps during the day due to the fatigue.
55 2021-04-25 pain in extremity, muscle spasms Severe spasms of lower back muscles stomach muscles shooting pain down the legs to the feet, chest p... Read more
Severe spasms of lower back muscles stomach muscles shooting pain down the legs to the feet, chest pain. Very elevated blood pressure. Was brought to the hospital by ambulance EKG done Blood pressure Cat scan Blood work Chest X-ray Follow up needed with primary care Dr Follow up with cardiologists needed Follow up with spine and pain doctor More blood work needed
55 2021-04-26 burning sensation, feeling hot this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burn... Read more
this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area/ The area is also really red and warm to the touch; frontal neck muscles are contracting under chin and on the sides; throat is burning; The area is also really red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 03Apr2021 at 14:15 (02:15 PM) (at the age of 55 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; and thyroid (ARMOUR THYROID) via unspecified route of administration on unspecified date at 15mg for unspecified indication. Medical history included hypothyroidism and known allergies to sulfa drugs. The patient previously took quinolines and experienced allergies. On 04Apr2021 at 10:00 AM, the patient experienced headache/pain in back of head, but also serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area. This began on day 2 and increased days 3,4,5,6, it became very pronounced after taking Armor Thyroid 15mg medication. It also feels like her frontal neck muscles are contracting under chin and on the sides and throat is burning. The patient called her doctor but no return call yet. She had normal labs several weeks ago for thyroid. She went today again as this feels like an auto immune thyroid attack. The area is also really red and warm to the touch. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The action taken in response to the events for ARMOUR THYROID was unknown. The patient had not yet recovered from the events. Information on the lot/batch number has been requested.
55 2021-04-26 pain in extremity, trigeminal neuralgia Employee woke up with triggered trigeminal nerualgia (previously diagnosis), and double vision, caus... Read more
Employee woke up with triggered trigeminal nerualgia (previously diagnosis), and double vision, causing vertigo and nausea. Her vision was better if she closed one eye. She was vomited throughout the day on 4/24/21, 4/25/21 - with the nausea, double vision and vertigo getting better on 4/26/21 and completely resolved on 4/27/21. On 4/27/21 employee reports aching, sore arm and fatigue. States she feels like she did when she had COVID 19 which she reports having in January 2021. Messaged her provider to see if she should get dose 2 of the COVID 19 vaccine.
55 2021-04-26 pain in extremity A little sore on arm.; This is a spontaneous report received from a contactable consumer (patient). ... Read more
A little sore on arm.; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7533) via an unspecified route of administration in the right arm on 27Mar2021 at 11:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, concomitant medications, allergies to medications, food or other products. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 at 19:00 the patient experienced a little sore on arm. The event was reported as non-serious and did not require hospitalization; no treatment was provided for the event. The clinical outcome of a little sore on arm was recovering. It was also reported the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are needed; no further information is expected.
55 2021-04-26 pain in extremity Fever, chills, nausea and vomiting this morning. Soreness of arm. Advised to please stay hydrated an... Read more
Fever, chills, nausea and vomiting this morning. Soreness of arm. Advised to please stay hydrated and drink fluids/Pedialyte to help with vomiting. Headache, fever, chills, malaise or "flu-like" symptoms are common side effects to the vaccine and should resolve in 2-4 days. Treatment of "flu-like" symptoms include common over-the-counter pain relievers/anti-fever medication such as ibuprofen, naproxen and acetaminophen (according to package instructions). See a healthcare provider if the "flu-like" symptoms last longer than 4 days.
55 2021-04-26 pain in extremity Approximately 8 weeks after receiving the 2nd Covid-19 injection in my Left arm, I woke up and my le... Read more
Approximately 8 weeks after receiving the 2nd Covid-19 injection in my Left arm, I woke up and my left arm was extremely painful at the injection site. Just as painful as it was the day I had my first injection. There was a hardened area around the injection site that was the entire width of my arm and about 2 " wide. No redness or warmth. I decided to try to massage the area and when I did, a very loud/audible CRUNCHING sound could be heard. It sounded like i was pushing on broken glass in my arm. My arm would ache down to my elbow after doing that. The harness and pain lasted about 2 weeks. The crunching improved but never went away. Now today, 12 weeks after the injection, my arm is starting to hurt again. No lump, but definitely an aching pain shooting down my arm, and an increase in the crunching/crackling sound.
55 2021-04-26 tension headache, feeling cold cold.fast breathing, angry, head feeling tight, psychotic episode
55 2021-04-27 burning sensation After the second dose about 3 or 4 days later my face started feeling sunburned and then peeled off ... Read more
After the second dose about 3 or 4 days later my face started feeling sunburned and then peeled off starting in left hand corner near hairline of forehead and progressing through the rest of my face. I did not report this on the app at the time because I did not link it to the vaccination. This has happened 3 times since April 2, 2021. Starting April 12, 2021 I noticed my legs starting swelling during the day. On April 27, 2021 I noticed a rash on the inside of both legs right above the ankles. I have also been very sleepy and tired during the month with bouts of nauseousness. Since my blood pressure was high 141/85 (taken by my school nurse where I work) while on medication on 4/27/2021 and legs swollen, with rash she recommended calling the doctor. The doctor scheduled an appointment for 4/28/2021. The doctor said he feels the repetitive face burning/peeling with the swollen legs and rash is a delayed allergic reaction to the COVID vaccination along with Vasculitis. He gave me a Methylprednisolone Dose Pack of 4mg.
55 2021-04-27 discomfort Patient call call center. Pt stated feeling very tired in afternoon everyday since got her 1st dose ... Read more
Patient call call center. Pt stated feeling very tired in afternoon everyday since got her 1st dose covid vaccine Pfizer on 04/06/2021 and feeling discomfort, not going away these sx. Denies fever or any other emergency sx at this time. Speech clear. Pt stated very concerned about to get 2nd dose covid vaccine and need to do consult with MD for her ongoing sx after got vaccine. Scheduled telephone consult appt with MD today at 3:45pm as per pt request for consult with provider. Notified pt to go to ED if any emergency sx arises,assure understanding.
55 2021-04-27 discomfort Red rash at injection site, extreme itchiness and discomfort under skin that didn't resolve after to... Read more
Red rash at injection site, extreme itchiness and discomfort under skin that didn't resolve after topical hydrocortisone.
55 2021-04-27 difficulty speaking I developed a twitch in my right eye within 4-5 hours of the shot that has not resolved apprx. 24 ho... Read more
I developed a twitch in my right eye within 4-5 hours of the shot that has not resolved apprx. 24 hours after the shot I experienced double vision that lasted 2 hours, the double vision has not returned as of now however the eye twitch has increased in severity. More common side effects I have experienced is fever (second day), chills (three days), body aches, headaches, sore/hoarse throat, heart palpitations., extreme exhaustion, Injection site pain.
55 2021-04-27 feeling hot Dizziness, hot inside. Patient stated that she is still feeling dizzy. Pt. refused transport to ho... Read more
Dizziness, hot inside. Patient stated that she is still feeling dizzy. Pt. refused transport to hospital. Pt. advised to call 911 and f/u with medical provider if symptoms persist. Pt. A+Ox3. Pt. verbalized understanding. O=100%, 190/106, BG 195, HR 108.
55 2021-04-27 hot flush Dizziness, nausea, hot flash. This happens every 3-4 days. I get so dizzy that I need to hold onto s... Read more
Dizziness, nausea, hot flash. This happens every 3-4 days. I get so dizzy that I need to hold onto something. I have never had any of these symptoms before I got the vaccine including when I had COVID. I had COVID Dec 2020.
55 2021-04-27 pain in extremity Hello! I had my first dose of the Pfizer shot on Sunday, 4/18/21. Everything was fine. Then, this ... Read more
Hello! I had my first dose of the Pfizer shot on Sunday, 4/18/21. Everything was fine. Then, this past Saturday, 4/24/21, six days later, I woke up with awful chills and aches. I went to be tested at the Clinic with the rapid test. The result was negative, but the NP said to quarantine and to get tested again in three days just to make sure. Later that day, my fever went up to almost 102. I had a dry cough throughout the day and some shortness of breath. I was sick until later that afternoon, when my symptoms dissipated after taking Tylenol. I was fine from then forward.. I quarantined and did the test yesterday through Medical Center. (They give both the rapid and the regular.) The rapid test result was "presumptive negative." Today, I got the results of the regular test,,and it was also negative. I'm very happy about this, but I wanted you to know, because I read that though it's rare, some people can have after effects of the shot almost a week after. (I had no immediate effects after the shot other than my arm was very sore.) I think this is what happened to me. I had no other symptoms Saturday other that the ones I described above. I wanted you to know for record-keeping purposes in case in you need the info. for COVID-19 research or other purposes. I'm fine now. Thanks!
55 2021-04-27 pain in extremity Patient complained of Left arm pain starting at time of injection but did not seek care until 4/22/2... Read more
Patient complained of Left arm pain starting at time of injection but did not seek care until 4/22/2021 in my office. She was diagnosed with DVT brachial vein in Left arm at elbow.
55 2021-04-27 tingling, pain in extremity Extreme Dizzyness, Fatigue, Double Vision/eyes not tracking, Headache on left side of head behind ea... Read more
Extreme Dizzyness, Fatigue, Double Vision/eyes not tracking, Headache on left side of head behind ear, burning left ear, Left ear fullness, Left eye pain, Wavy sensation in scalp, tingling on left side of face, left arm and leg, Pain in left arm. Slight tinnitus, Neurologic symptoms in head
55 2021-04-28 feeling hot POST VACCINE, STARTED FEELING HOT/SWEATY, NAUSEOUS, THEN WENT TO STAND UP AND FELT DIZZY. BROUGHT TO... Read more
POST VACCINE, STARTED FEELING HOT/SWEATY, NAUSEOUS, THEN WENT TO STAND UP AND FELT DIZZY. BROUGHT TO OBS TO LAY DOWN, VSS. SAT UP AS S/S RESOLVED, EXCEPT NAUSEA. SNACK AND WATER PROVIDED. ESCORTED TO EXIT WITH NO FURTHER ISSUES VIA WC ONCE NAUSEA RESOLVED AT 1240. 1210 BP 166/89 HR 88 SATS 97% RA 1220 BP 159/77 HR 87 SATS 97% RA 1230 STANDING BP 145/70 HR 97 SATS 97% RA
55 2021-04-28 feeling hot Moderate muscle pain and stiffness in the right upper back muscles starting 2 days after the vaccine... Read more
Moderate muscle pain and stiffness in the right upper back muscles starting 2 days after the vaccine. This is a site of previous injury from a presumed electrical shock in ~2000. In 2011 I have had shooting nerve pain from the spine along this area. This is the first time I have had muscle pain and stiffness there. DURATION: the mild to moderate pain continued for ~7 days with new tiredness during days 2 through 6. The stiffness with very mild discomfort continues. This localized pain feels confined to the muscles/ tissue of my right upper back next to the spine. One of the days of tiredness was accompanied with whole body stiffness, feeling warm, chest tightness and hyperventilation. I did not take my temperature
55 2021-04-28 numbness 2 hours after the 2nd Pfizer Covid vaccine my LEFT EAR went NUMB. It's still numb 53 hours later I c... Read more
2 hours after the 2nd Pfizer Covid vaccine my LEFT EAR went NUMB. It's still numb 53 hours later I can't tell if I'm hearing worse or the same, but hearing SEEMS to be intact I hear some "whooshing" noises from time to time but thankfully not all the time It does not hurt It feels like had local anesthesia that won't wear off
55 2021-04-28 pain in extremity, migraine After second dose on 4/2/21 I had a shooting pain go across my forehead, instant migraine behind rig... Read more
After second dose on 4/2/21 I had a shooting pain go across my forehead, instant migraine behind right eye. Pain then shot down right arm and elbow and right hand began throbbing with pain. I could not find someone, but felt ok after drinking water and sitting for the 15 minutes. I did leave with a slight headache behind right eye that lasted until 4/3/21. On 4/5/21 I woke up with tinnitus. I thought it would go away. It continued to get worse and is now 24 hours a day. I went to my Dr on 4/14/21 and was told to see an ENT. I went to an ENT on 4/26/21
55 2021-04-28 pain in extremity weakness in her left arm; pain is increasing; Total hysterectomy; pain is up to her shoulder and dow... Read more
weakness in her left arm; pain is increasing; Total hysterectomy; pain is up to her shoulder and down to her elbow; waking her up at night; soreness in her left arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No. EL3246; Expiration Date: unknown) via an unspecified route of administration in left arm on 30-DEC-2020 09:15 at single dose (age at vaccination: 55-year-old) for COVID-19 immunization and patient had second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No. EL9251; Expiration Date: unknown) via an unspecified route of administration in left arm on 20Jan2021 1:30 PM at single dose for COVID-19 immunization. The patient medical history included high blood pressure (From: Unspecified To: Ongoing). The patient concomitant medications included losartan: (Start: Unspecified Stop: Ongoing), taken for 7 years, amlodipine: (Start: Unspecified Stop: Ongoing) taken for 7 years. It was reported that, she has had both vaccines. First vaccine on 30Dec2020 and the second vaccine on 20Jan2021 and she is having pain. She wasn't having pain, just soreness in her left arm. But that soreness has gotten worse now. She also reports that when she got her first Covid 19 vaccine, the person who gave the injection went straight into her arm with the needle and when she got the second vaccine the person who gave the injection went more towards the back of her arm with the needle. The first injection where the needle went straight on has bothered her since 30Dec2020. She also has weakness in that left arm and it's waking her up at night. She is an administrator and was in the first phase of people who received the Covid 19 vaccine. she did tell the attendant giving her the second Covid 19 vaccine that she was still having soreness in her left arm. That person told her soreness in her arm was normal. She reports she had a total hysterectomy on 18Feb2021 and had preop labs done at that time. Her primary care doctor has not ordered any labs related to her issue with her left arm. On an unknown date in Apr2021, the pain is increasing, and the arm is getting weak. The attendant giving her second vaccine did ask her if she wanted the injection in the right arm, her other arm and she said no. She is right hand dominant, and she needed one working arm. On an unknown date 2021, that soreness, that pain is up to her shoulder and down to her elbow. She reports her doctor did reflex testing and asked the caller to squeeze the doctor's hands and push down on her hands like a strength test to see if there was equal strength. The doctor told her she had less strength in her left arm than her right arm. She had gone to the doctor for a blood pressure check and while she was there, she mentioned to her doctor the problem with her arm. She had gone to the doctor for a blood pressure check and while she was there, she mentioned to her doctor the problem with her arm. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event hysterectomy was unknown, for rest of the events it is not recovered. No follow-up attempts possible. No further information expected.
55 2021-04-28 tingling had normal fatigue after vaccination that started the following morning, parasthesias in left side ... Read more
had normal fatigue after vaccination that started the following morning, parasthesias in left side of face and left leg below knee, comes and goes, worse in am and pm and when tired
55 2021-04-28 speech disorder Chest Tightness , difficulty speaking , ANAPHYLAXIS
55 2021-04-29 numbness, flushing Flushing/sweating, dizziness, numbness on arm/lips. Rested and had water. BPs 158/100 (pulse 125), 1... Read more
Flushing/sweating, dizziness, numbness on arm/lips. Rested and had water. BPs 158/100 (pulse 125), 171/105.
55 2021-04-29 numbness, pain in extremity, burning sensation Shot burned severely on injection in right arm. In less than 5 minutes, a wave of numbness started ... Read more
Shot burned severely on injection in right arm. In less than 5 minutes, a wave of numbness started at left ear and progressed in a wave across about 3/4 of face. Both lips swelled; more in lower lip. Burning sensation in arm continued for approximately 3 hours. Minor arm pain for approximately 24 hours. Periodic low fever (99.4-99.9) for 3 days. Still no recovery of face.
55 2021-04-29 numbness Pt. Received second covid-19 vaccine today. After 15 minutes she reported numbness to her left side ... Read more
Pt. Received second covid-19 vaccine today. After 15 minutes she reported numbness to her left side of face. Also a mild headache and dizziness. She is alert and oriented times four and equal good strength to arms and legs bilaterally. No facial droop noted. Vital signs at this time (13:23): BP: 138/83, HR: 75, O2:98%.She denies any medical history or allergies at this time. Benadryl not given due to no ride. Provider was called and given report. She advised to do a stroke assessment and call 911. Vitals at this time (13:36): BP: 165/85, HR:72, O2: 99%. LVN called 911 and gave report. Advised by 911 to not provide food or liquids. As paramedics pulled up, Pt. Complained of difficulty swal
55 2021-04-29 muscle spasms 7 days post jab feeling nauseous, muscle cramps in hands, vertigo
55 2021-04-29 pain in extremity After the 1st dose, I had sore arm and days later I had itchy rash around my right arm pit and my gl... Read more
After the 1st dose, I had sore arm and days later I had itchy rash around my right arm pit and my gland with swollen in the arm pit. After 2nd vaccine, sore arm and was tired for about 48 hours. Days later I'd noticed little itchy bumps on my left eye lid. On the night of 4/23, now both eye lids were itchy and a bit red. Throughout 4/24, eye lids got a little more swollen and still itchy and red, and by the evening my lips started to tinkle and a little bit swollen (it felt like I'm getting a cold sore) and I had noticed a few little bumps on the edge of my upper left side of lip (in a straight line). Throughout 4/25 my eye lids and lip were a little more swollen and feels like I'm having cold sore/sunburn. I
55 2021-04-29 tingling, numbness Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: PATIENT FELT TINGLING IN HER LEG,THEN NUMBNESS IN HER ARM-911 WAS CALL AND PATIENT LEFT WITH PARAMEDIC
55 2021-04-30 facial paralysis, muscle twitching both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my d... Read more
both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE)), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:30 (Batch/Lot Number: EP7533) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation . Medical history included high blood pressure (HBP) from an unknown date and unknown if ongoing , supraventricular tachycardia (PAT) from an unknown date and unknown if ongoing, had Bell's palsy from 2001 to an unknown date. No known allergies. Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; enalapril taken for an unspecified indication, start and stop date were not reported. The patient did not have any vaccines in four weeks and did not have covid prior to vaccination. In 2001, the patient had Bell s palsy (Medical history). Her left side paralysis never fully went away. Now, both of her doses of vaccine led to facial tightening, twitching, and slightly more paralysis on 23Mar2021 11:30 with outcome of unknown. She did not regret taking the vaccine and would do it again. Her mainly reason for reporting this was that she wanted to know if the vaccine was still effective. No treatment was received. No covid test post vaccination.
55 2021-04-30 migraine The vaccine triggered a major migraine episode- up to level 9 pain, total duration approximately 72 ... Read more
The vaccine triggered a major migraine episode- up to level 9 pain, total duration approximately 72 hours.
55 2021-04-30 muscle spasms, numbness and pain in extremities 1) Nerve issue/cramping in 3 fingers on left hand; 2) Persistent headache in different sections of m... Read more
1) Nerve issue/cramping in 3 fingers on left hand; 2) Persistent headache in different sections of my head, more pronounced on right side of head & in a cluster); 3) Standard responses: fever, chills, body ache, run down feeling, and mild swelling in throat.
55 2021-04-30 pain in extremity ?Pfizer-BioNTech COVID-19 Vaccine EUA: Pain in right arm 3 hours after 2nd dose. Pain became gener... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA: Pain in right arm 3 hours after 2nd dose. Pain became generalized. Fever on 5/1/2021 at 4:30am of 100.3
55 2021-04-30 pain in extremity not feeling well; threw up; her legs felt heavy like she had just finished exercising.; lower back p... Read more
not feeling well; threw up; her legs felt heavy like she had just finished exercising.; lower back pain; nausea; headache; experiencing pressure behind her eyes; She felt absolutely exhausted; Eyes feel heavy; felt like she had been hit by a truck/Just don't feel myself; arm started hurting/ arm pain/pain in top of legs; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Mar2021 at 09:45 on the right arm as single dose for COVID-19 immunization. Medical history included diabetes mellitus from 2014 and ongoing; ongoing unspecified blood pressure condition that diagnosed with blood pressure problems in the early 2000's; ongoing unspecified cholesterol condition that diagnosed with cholesterol problems in the early 2000's; ongoing chronic fatigue. No family medical history relevant to events. Concomitant medications included lisinopril from 2014 and ongoing for blood pressure measurement; atorvastatin from 2014 and ongoing for blood cholesterol. Patient did not have previous immunization with the Pfizer vaccine considered as suspect, no additional administered vaccines. No prior vaccinations within 4 weeks and no events following prior vaccinations. Patient was scheduled on 18Apr2021 for the second dose of the Covid-19 vaccine. Patient arm started hurting on Monday 29Mar2021 or Tuesday 30Mar2021. Patient reported that her arm didn't hurt for very long, just if she rubbed up against something like the shower nozzle. The arm pain went away completely. On 28Mar2021 around 15:00, patient felt like she had been hit by a truck and that she needed to lay down. Patient got up a few hours later and felt fine; also felt better a few hours later after laying down. On 02Apr2021, patient developed a massive headache on the back right side of her head. She later reported that the headache was now in the left side of her head. The whole time since 02Apr2021, she had been experiencing pressure behind her eyes and she can't focus because her headache was so bad. The headache went down into her neck. The headache had been coming and going, sometimes in back of her head and went down into her neck. On 14Apr2021 that the headache was on the left side of her head, when she went to the doctor on 05Apr2021, headache was just on the left side going down into her neck, but now it was on the left side going up the top of her head to down by the corner of her left eye. Patient reported that she didn't get headaches and that she didn't live off of Tylenol every 6 hours. Patient had a headache that won't go away and taking Tylenol around the clock every 6 hours and Benadryl every 12 hours. Patient was starting to get concerned why her head hurts so bad when she doesn't normally get headaches. Patient reported that beginning 02Apr2021, she felt absolutely exhausted. She already had chronic fatigue, but this was much worse. Patient sit on the couch and her eyes felt so heavy that she can hear her husband talking but can't look at him. The exhaustion comes and goes. There can be day where she gets up and feels ok, then a couple hours later it starts. Patient stayed in bed 02Apr2021 through 04Apr2021. Patient was not a person that lays in bed all day, but that after 02Apr2021, that was all she had been doing. Patient reported that she had an existing appointment with her physician on 05Apr2021 and added the side effects she had been experiencing since 02Apr2021 to the appointment. Her physician ordered a bunch of labs, inflammation markers and everything, and that all of the bloodwork came back normal. The patient was not feeling well since everything came back kosher at the doctor and got an ok from the physician. Patient inquired why it took 7 days for the side effects to hit, for her to get a headache that won't go away. Patient had nausea comes and goes on 02Apr2021, she also was experiencing nausea on 14Apr2021 and that she threw up on 13Apr2021. Patient took ginger for the nausea. Patient originally reported that the lower back pain felt like someone had kicked her in the kidneys on 12Apr2021. On 14Apr2021, the back pain didn't feel like someone kicked her in the kidneys anymore but it's still there. The lower back pain was not going anywhere but it was not putting her down in the ground. Patient had pain in top of legs on 13Apr2021, she laid down and got up to make something to eat. Patient was in the kitchen with her husband and she reported to her husband that she felt like she couldn't stand, and she needed to go sit back down. Her legs felt heavy like she had just finished exercising and a little while later the pain in her legs was gone. Patient just didn't feel herself on unspecified date. Lab data included the normal result of the CBC with auto differential on 05Apr2021 included white blood count, hemoglobin, hematocrit, MCV, MCH, MCHC, platelet count. Her physician informed that her white count was normal and did not include any signs of infection. Her doctor informed that the sedimentation rate was an inflammation marker and that it was normal. No events required a visit to emergency room, and had a physician office visit for events headache, nausea, exhaustion. The outcome of the events headache, lower back pain, nausea was not recovered, while of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-04-30 tenderness felt tenderness; felt a nodule; Swollen lymph node; Tired; This is a spontaneous report from contact... Read more
felt tenderness; felt a nodule; Swollen lymph node; Tired; This is a spontaneous report from contactable consumer. A consumer (patient) reported for herself that the 55-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer Covid-19), via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:40-10:45 (Batch/Lot Number: ER8727) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tired on 26Mar2021 13:00 with outcome of recovered, felt tenderness on an unspecified date with outcome of unknown, felt a nodule on an unspecified date with outcome of unknown, swollen lymph node on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of tired. The clinical course was reported as follows: She received her second dose at 1040 yesterday. Her first dose was fine, she was just tired. Today she was fine in the morning, she was is a little tired now, she seems to have a swollen lymph node like up on her neck, right above her clavicle. She noticed it was a side effect and is asking if it is temporary. She felt tenderness, felt a nodule. Caller asking will it go away in 48hours. Caller doesn't have a physician at this time. She got tired today at 1230. That was the primary symptom the first day after the first dose also. It was not so much that she couldn't function, she was just tired. Caller works remotely. She went and sat on the couch hoping to take a 15 minute cat nap. She laid down and thought why is her neck sore? She touched the area and felt the nodule. This was 1230-100pm this afternoon about 25-26 hours after the second shot. It's not worse or better. She was tired after the first vaccination on 25Mar2021 at 1040 or 1045. It started on 26Mar2021 about 24-28 hours after around 1300. It stopped on 27Mar2021, she awoke feeling fine, and recovered completely. Second dose LOT EW0158, left arm injection She is on no medications, she takes vitamin C and vitamin D in the mornings. She has no medical conditions. Caller tried here first and figured she would start here and if it was recommended to her to see a physician, she has one she has been referred to. No AE require a visit to Emergency Room or Physician Office. No relevant tests. No follow-up attempts are needed. No further information is expected.
55 2021-04-30 unresponsive to stimuli, seizure Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hype... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypertension-Severe, Systemic: Seizure-Severe
55 2021-05-01 pain in extremity sore arm, headache, full-body muscle aches, fever, chills, decreased appetite, tiredness took two 10... Read more
sore arm, headache, full-body muscle aches, fever, chills, decreased appetite, tiredness took two 1000 mg doses Tylenol over 36-hour period, slept, rested & tried to eat as much as possible symptoms completely gone within 60 hours of onset
55 2021-05-02 weakness, burning sensation, tingling Weakness, blurred vision, dizziness started 30 minutes after vaccine. Next morning weakness and blur... Read more
Weakness, blurred vision, dizziness started 30 minutes after vaccine. Next morning weakness and blurred vision and weakness worse and pins and needle burning sensation in forearms hands lower legs and feet. Symptoms kept getting worse . Saw neurologist for normal fun and was given iv decadron to calm symptoms down. Still suffering from these symptoms and Dr thinks it is MS flair will be getting high dose steroids to see if it can cal things down
55 2021-05-02 pain in extremity, migraine Nausea, migraine, very sore arm, unable to lift arm above shoulder height, vertigo
55 2021-05-02 pain in extremity, tenderness Sore right arm with tenderness under the arm and pronounced blood vessels. on 5/1 and 5/2 started to... Read more
Sore right arm with tenderness under the arm and pronounced blood vessels. on 5/1 and 5/2 started to develop swollen lymph nodes. Will monitor and take tylenol/motrin- dual action form Q8H. Will report to the hospital with worsening symptoms such as change in vision, whole arm numbness, and or increasing size of lymp nodes under arm.
55 2021-05-02 pain in extremity h/a, neck pain and right arm pain
55 2021-05-02 tenderness Swelling of the injection site both times. After the second dose experiencing swelling of the arm, ... Read more
Swelling of the injection site both times. After the second dose experiencing swelling of the arm, tenderness, lymph nodes under the arm pit in the same arm of the injection.
55 2021-05-02 tremor Dizziness; lightheaded; shaky. Given apple juice and water. Stable and released from vaccination sit... Read more
Dizziness; lightheaded; shaky. Given apple juice and water. Stable and released from vaccination site.
55 2021-05-03 nerve pain, pain in extremity Complaining of left arm pain 2 weeks started after 2nd dose of COVID-19 vaccine. She states pain rad... Read more
Complaining of left arm pain 2 weeks started after 2nd dose of COVID-19 vaccine. She states pain radiates down left arm and feels like nerve pain. She denies any chest pain, shortness of breath or any exertional dyspnea or increas pain with activity. Pain worse with movement of left arm
55 2021-05-03 pain in extremity Swollen painful fingertips , and tinnitus.
55 2021-05-04 weakness, tingling, numbness 5 days after getting covid vaccine vaccine #1 developed a numbness/tingling to posterior legs with ... Read more
5 days after getting covid vaccine vaccine #1 developed a numbness/tingling to posterior legs with a reported bilateral weakness starting in feet and legs that moved up to her upper body. She described it as "feeling like something was pushing down on me making it hard for me to stand" she continued to feel very tired and when she struggled to lift up a milk jug she went to the ER for further evaluation on 4/25/21
55 2021-05-04 weakness Shortness of Breath ? Sinus Problem ? Generalized Body Aches ? Weakness, Fatigue, Diarrhea, leukop... Read more
Shortness of Breath ? Sinus Problem ? Generalized Body Aches ? Weakness, Fatigue, Diarrhea, leukopenia
55 2021-05-04 migraine Migraine that lasted 10 days, head pain similar to onset of Bells Palsy
55 2021-05-04 muscle spasms My left arm is locked in a paralyzed stage where I haven't been able to lift it no more than a few i... Read more
My left arm is locked in a paralyzed stage where I haven't been able to lift it no more than a few inches since the second week that I got the Pfizer shot three weeks ago. The left side of my shoulder and neck was stiff like I had a muscle spasm for about the whole second week. I informed Nurse at my doctor's visit on April 28th at . She advised me to apply heat on the areas, move and rotate the areas and to continue to take Tylenol, I still am not able to fully lift my left arm. I will not be getting the second shot on May 6th 2021.
55 2021-05-04 muscle spasms Face Swollen, Headache, Body aches, Muscles Spams, Arm Swollen
55 2021-05-04 pain in extremity Elevated liver enzymes: before vaccination 4/15/ test ALS 28, ALT 31. After vaccination test 5/3 AL... Read more
Elevated liver enzymes: before vaccination 4/15/ test ALS 28, ALT 31. After vaccination test 5/3 ALS 208 ALT 165 the others: nausea, let's arm pain ,headache , fatuque
55 2021-05-04 pain in extremity Muscle aches; Extreme fatigue; sore arm; This is a spontaneous report received from a contactable (r... Read more
Muscle aches; Extreme fatigue; sore arm; This is a spontaneous report received from a contactable (reporting on herself) via Pfizer Sponsored Program. A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 29Jan2021 14:15 as single dose for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: (diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity) was Animal dander, Pollen and Asthmatic from 1966 to an unknown date. Family Medical History includes: Father Asthmatic and Mother Allergies. The patient's concomitant medications were not reported. Historical vaccine include first dose of BNT162B2 on 08Jan2021 and patient experience sore arm. It was reported that on 29Jan2021patient got the vaccine shot (yesterday) and said that she got a sore arm. On 30Jan2021 at 12:00 Extreme fatigue and at 15:00 Muscle aches. Patient took Advil on 29Jan2021 and stop on 31Jan2021. The outcome of the events recovered on an unspecified date. Information on the lot/batch number has been requested.
55 2021-05-04 tingling Patient returned to site immediately after leaving. She complained of facial tingling along with h... Read more
Patient returned to site immediately after leaving. She complained of facial tingling along with her tongue. Patient was assessed and found to not have any obvious cardiac or respiratory distress. Patient was advised to take Benadryl when she returned home.
55 2021-05-05 weakness Passed out on the road while on a walk with friends . Unable to standup w balance and weakness. Wen... Read more
Passed out on the road while on a walk with friends . Unable to standup w balance and weakness. Went to ER and was a TIA code. Full work up MRI, TC scan, chest X-ray, blood work, heart monitor COVID test. All were negative. Symptoms seem to have worsen (tired, weak, no appetite, diarrhea, confusion while talking). My fall was on my left side never hit my head and my hands have no cuts, that would show I braced my fall.
55 2021-05-05 pain in extremity, feeling hot Woke out of sleep with bad chills. Had fever because my body was very hot. I had body aches. I d... Read more
Woke out of sleep with bad chills. Had fever because my body was very hot. I had body aches. I didn't roll over onto my sore arm. I had a headache. I only got out of bed to use bathroom, couldn't eat anything for 1 day. symptoms remained for about 24 hours. 3 hours into it i took tylenol -that helped. In the beginning I felt nauseous. I knew it would end, but it was very difficult during that time. It took about 2 days after to feel back to normal.
55 2021-05-05 pain in extremity After almost 10 days after the injection my neck was in a lot of pain. I couldn?t turn it. Soon afte... Read more
After almost 10 days after the injection my neck was in a lot of pain. I couldn?t turn it. Soon afterwards, the whole left side of my neck swelled up including near the clavicle of my neck. My initial symptom after the vaccine was only a sore arm and headache.
55 2021-05-05 tenderness Menstrual cycle started right at my 10 month of not having one for seven days . Menstrual cycle fo... Read more
Menstrual cycle started right at my 10 month of not having one for seven days . Menstrual cycle for myself only last 3 to 5 days and was very painful ( Back and Breast tenderness ) I also have bruises on my upper right and left arm on my left thigh and on my right ankle round red circles
55 2021-05-06 weakness 8 hours in severe pain below the injection site I have used ice and heat with no relief. Extremely... Read more
8 hours in severe pain below the injection site I have used ice and heat with no relief. Extremely painful to raise my arm up. 16 + hours in, I also woke up with a severe debilitating headache but proceeded to do a 5 min elliptical and 5 min ab workout. 23 hours in fatigue, fever, exhausted, eyes light sensitive and ache. Worked for 1/2 day and could not finish work. I had to lie down to weak to fix my own lunch. Now reporting these symptoms.
55 2021-05-06 hypersensitivity of all senses Started to feel itchy pain in middle of back. Progressed to intense pain where I could not wear a br... Read more
Started to feel itchy pain in middle of back. Progressed to intense pain where I could not wear a bra or tight clothing. Lasted 7 days. I concluded it was non-herpetic shingles.
55 2021-05-06 migraine with aura Severe Migraine wuth Aura
55 2021-05-06 migraine Severe headache/body aches/cough, fever, OTC Tylenol Migraine.
55 2021-05-06 pain in extremity, sciatica Patient started having unilateral shoulder pain 2 weeks following dose 1 of Pfizer injection, then p... Read more
Patient started having unilateral shoulder pain 2 weeks following dose 1 of Pfizer injection, then progressed to bilateral hip pain. Received 2nd dose and the following day had severe pain in arm, extensive lymphadenopathy. Pain in shoulders and hips increased, having difficulty with bending and ambulating, sciatic pain, cannot lift left arm at all at this time, difficulty sleeping due to pain and increased heartrate at night. Suspect development of autoimmune reaction post vaccination. Encapsulated shoulder requiring surgical intervention.
55 2021-05-06 tingling 55 year old female who has completed a 30-minute observation period with the following signs and sym... Read more
55 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: other - reports dizziness,facial tingling,ha,throat tightness, rapid respiration. Pfizer-BioNTech COVID-19 vaccine # 1 in series administered. o Action(s) taken: Epinephrine administered AT 1304, transferred to higher level of care o Allergy to COVID-19 vaccine documented in Aller
55 2021-05-06 seizure Patient had a seizure.
55 2021-05-06 tremor, discomfort, feeling of body temperature change Hot and cold, unsteady, heart rate 122, throat tight, shaking, very dry throat/mouth, heavy feeling ... Read more
Hot and cold, unsteady, heart rate 122, throat tight, shaking, very dry throat/mouth, heavy feeling traveling around body, feeling very unwell. Lasted about 90 mins
55 2021-05-07 bell's palsy Bell's palsy; This is a spontaneous report from a contactable physician and consumer (receptionist).... Read more
Bell's palsy; This is a spontaneous report from a contactable physician and consumer (receptionist). A 55-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccines received on four weeks. Patient was not pregnant. The patient experienced bell's palsy on Apr2021 which caused hospitalization. Prednisone was given as treatment. Outcome of the event was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Bell's palsy due to temporal relationship and current known drug safety profile. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
55 2021-05-07 facial paralysis, facial pain 4/15/21 - right outer ear pain. 4/19/21 - saw Dr. on demand - prescribed Amox-Clav 875-125 mg 2X a d... Read more
4/15/21 - right outer ear pain. 4/19/21 - saw Dr. on demand - prescribed Amox-Clav 875-125 mg 2X a day. 4/20/21 - right facial swelling - went to urgent care. Dr. said to stay on prescription given to fight bacteria infection. 4/27/21 - saw Dr. - prescribe Azithromycin 250 mg 2 tablet a day and Ciproflox-dexamerh ear drop. Again - diagnose as bacteria ear infection. 4/29/21 -right face paralysis-extreme pain. 4/30/21 - went to urgent care - extreme pain - Dr. directed to go to Hospital Emergency Room for CT scan and blood work. Diagnosed from Hospital ER is 1. Otitis external of right ear. 2. Facial nerve palsy 3. Ramsay Hunt Syndrome - auricular. Prescription-Acyclovir 400MG tablet 5x per day for 7 days. Prednisone 50 mg daily for 7 days. Hydrocodine-acetaminophen 5-325 mg as needed. Ask to follow up with ENT specialist on paralysis. Appointment made for 05/10/21 afternoon. Pain and swelling persisted throughout ordeal.
55 2021-05-09 flushing, tingling Patient left vaccination site after waiting 15 minutes post vaccination. Approximately 15-20 minutes... Read more
Patient left vaccination site after waiting 15 minutes post vaccination. Approximately 15-20 minutes later she experienced facial flushing, tingling and "itchy throat" confined to her face and neck. She returned to the vaccination site, was seated, and assessed. She denied symptoms of shortness of breath or swelling of the throat or tongue. Her radial pulse was steady and regular at 80 BPM. She denied sx of tachycardia, orthostasis. There was no audible stridor. Her BP was measured at 125/70 mm Hg. She was treated with 12.5mg of liquid diphenhydramine. This dose was repeated approximately 20 minutes later since her sx did not improve. The patient was given bottled water and consumed approx 16 oz over the course of 30min. She was also given a cold wet face cloth for symptomatic relief of the flushing. The patient got up X2 to use the restroom w/o event - denied dizziness or orthostasis. After approx. 50 min the pt was determined to be stable and contacted a family member to drive her home. She left the clinic without incident.
55 2021-05-09 tingling, hot flush She states she initially experienced some light headedness. Staff checked BP and it was elevated170... Read more
She states she initially experienced some light headedness. Staff checked BP and it was elevated170/90. She developed left sided facial tingling. They brought inside and had her lie down with her legs elevated. She experienced hot flashes, which she has had before, but not for a while. Her repeat BP was 230/90 and EMS was called. Repeat BP was 196/90. She declined to go to ER and signed refusal. She went home, showered and went to bed. She awoke with her BP more elevated, continued left facial tingling and self treated with apple cider vinegar and went to ER. Her BP was 150/80, they did EKG, CT head and blood work which were normal. Event did not recur with dose #2. BP 134/85. at baseline; was checked at 15 and 30 minutes and remained stable.
55 2021-05-10 hypersensitivity of all senses, migraine feeling in her skin and with a slight touch it has a sharp sharp pain in it; her elbow has a really ... Read more
feeling in her skin and with a slight touch it has a sharp sharp pain in it; her elbow has a really weird prickly sensation/ really painful; a loss of smell and taste; a loss of smell and taste; couldn't really hardly eat; felt really really really bad/felt really foggy; had a migraine headache; getting sick; sleeping all day; throat is dry; extreme chills; a fever to the chills; extreme vertigo; was totally nauseous and started vomiting; was totally nauseous and started vomiting/ throwing up; had a slight headache/ lingering headache / still had the headache and it was worse; had fatigue and went to bed early, was really really tired/had off and on fatigue; sore arm from the injection; This is a spontaneous report from a contactable consumer reporter. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7533, Expiration date: 02JUL2021), via unspecified route of administration in left arm on 06APR2021 08:00 (at the age of 55-years-old) for COVID-19 immunisation at drug store. The medical history and concomitant medication were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Apr2021, that day patient walked, and she felt 100 percent and was great and walked in there and was fine when she walked out; states she had a sore arm and she stuck around for at least 30 minutes at the drug store and had a sore arm from the injection. Later that night about 8:00pm she had fatigue and went to bed early, was really tired and had a slight headache that started around 9:00pm; woke up throughout the night with a headache and going to the bathroom she still had the headache and it was worse and then at 05:30am she woke up and felt really bad and it felt like she had a migraine headache. Patient had extreme vertigo and it happened when she really slightly lifted up her head when she went to turn around and occurred especially when she was turning on her right side or getting up in bed there was more vertigo; states all through the day she had vertigo and could not lay on her right side and had more vertigo when she leaned on her right side; states she was nauseous and was totally nauseous and started vomiting about 6:00-6:30am the next day (07Apr2021); states she had the migraine, vertigo and nausea and got up to go back to bed and got sick and got up again and started throwing up. Reporter stated that the patient all day long the headache was ongoing, and she was either vomiting and it was horrific and horrible and she was either getting sick or laying down and it completely hit her just like a truck hit her or something; states she was either sleeping or vomiting all day and then went to sleep again and was vomiting all day and tried soda crackers to stop herself from throwing up and threw those crackers up and that was all she ate that day. Patient had vertigo a little bit the next day and when she went to turn on her right side by the end of the day the vertigo seemed to go away and went away eventually; states now her throat was dry. Patient continued with the headache when she woke up the next day after that and all 07Apr2021 (Wednesday), she vomited, had extreme vertigo and had the migraine headache; states she was extremely fatigued and was sleeping all day when she was not vomiting and had extreme chills and a fever to the chills and felt like that through the whole day and the next day after she woke up with a headache, she had the chills and vomited once; states on Thursday she still had the headache, vomiting, and nausea and vomited again and the chills again that morning and was really fatigued and was going back to sleep until about 1:00pm that day. Around 2:30 that day she started eating a little bit of a banana and couldn't really hardly eat and at least held that down without getting sick and had fatigue all through the day; states the next day on Friday she woke up with a headache and fatigue and no chills or fever; states it was just her headache in the morning and fatigue and finally got his appetite back that Friday; states she started eating more and was not overdoing eating and had more vegetables and fruit. On10Apr2021 (Saturday), she woke up with the headache again and felt a little fatigue earlier and felt better; had off and on fatigue, no chills and basically had the headache and fatigue. On 11Apr2021 (Sunday), she was feeling much better and did not wake up with a headache for the first time and seem to be good all the way though and had no headache Sunday to Friday but did have off and on fatigue and the fatigue was sometimes better than other days and on 17Apr2021 (Saturday), she woke up with a headache again and felt really foggy, fatigued on Saturday all through the day felt off; states she did not go to bed late and has not had alcohol since 2 days before the Pfizer shot and was scared to have anything. On Sunday she woke up with a headache again and felt fatigue and fell asleep which was really odd for her and after that got up at 5:30pm at night; was fatigued through the day and in the morning had a lingering headache which was not severe and was mild on 18Apr2021 (Sunday). Patient was watching the news and fell asleep which was so not her and ended up feeling fatigued after 9:00pm and went to bed; on Monday this week woke up with a slight headache again and was a little bit fatigued; on Tuesday yesterday did not wake up with a headache which was gone and no headache today but felt kind of foggy yesterday and has no fogginess today and am fine today with no headache. 20Apr2021 (Yesterday, one day before this report), the patient noticed over the last two days she has a loss of smell and taste and that was ongoing yesterday and today; her elbow has a really weird prickly sensation on the tip of her elbow on the left side and when she turns it she feels it a bit and it was really painful and really weird which started yesterday and feels it a little bit today; states her elbow feels like it has shattered glass in it and she still has that today and it seems a little better but was really weird when she woke up with this feeling in her skin and with a slight touch it has a sharp sharp pain in it and subsided a bit. Patient was now concerned about getting the 2nd dose of the Pfizer vaccine and wants to get the 2nd shot because she does not want to take a chance of dying in the future which was basically what her HCP said; states she was horrified of getting the 2nd dose of the vaccine if the 2nd dose she was sick like she was after the 1st dose; states she knows people that hardly had any symptoms after the Pfizer Vaccine and they did not have symptoms until the 2nd shot; states she does not know what to do with her circumstances and that was her question. It was reported that the adverse events resulted in visiting of the MD office. At the time of this report events, headache, feeling abnormal were resolved 21Apr2021 and chills, decreased appetite and pyrexia on 09Apr2021, outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.
55 2021-05-10 muscle spasms, involuntary muscle movements Muscle pain; muscle spasms; Problem moving, mobility problem; This is a spontaneous report from a co... Read more
Muscle pain; muscle spasms; Problem moving, mobility problem; This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's sister). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 (Lot Number: EN620) as single dose for COVID-19 prevention. Medical history included diabetes from 2007 and ongoing, hypertension from 1998 and ongoing. The patient concomitantly took medicine and a whole lot, that was too much. The patient previously received first dose of BNT162B2 on 11Mar2021 (lot number EN620, it looks like 7). In Apr2021, the patient experienced muscle pain and muscle spasms and she had to go emergency room twice; had problem moving, mobility problem. She had never had this experience. It was very severe, very traumatic for her to go the emergency room twice. Treatment was received for events. For muscle spasms she was taking Ketorolac 10 mg. They take her blood and urine at emergency room, CT-scan, X-ray. It had been over a week, she had the vaccine second shot on 01Apr2021, and it was 14Apr2021. It was getting better by taking medications, medication was giving relief. The outcome of events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-05-10 muscle spasms, pain in extremity Heart racing, heart was skipping beats for up to two weeks 3-4 times a day and about once every othe... Read more
Heart racing, heart was skipping beats for up to two weeks 3-4 times a day and about once every other day the 3rd week. Pains in legs.
55 2021-05-10 pain in extremity Pain at injection site; arm pain; This is a spontaneous report from a contactable consumer (patient)... Read more
Pain at injection site; arm pain; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 15Apr2021 15:00 (Batch/Lot Number: EP7534) at age of 55-years-old as single dose for covid-19 immunisation. Medical history included aplastic anemia from 2001, myelodysplastic syndrome (MDS) from 2009, graves disease 1970s diagnosis, past myocardial infarction (MI), antiphospholipid antibodies (APLA), stroke, seizure due to stroke, bone marrow transplant in 2009. Prior to vaccination, the patient was diagnosed with COVID-19. Known allergies included mostly antiseizure meds, dilantin, depakote, CT contrast. Concomitant medication in two weeks included levothyroxine sodium (SYNTHROID); lifitegrast (XIIDRA) taken; estrogens conjugated (PREMARIN); acetylsalicylic acid (ASPIRIN); vitamin d (VITAMIN D NOS). No other covid prior vaccination. The patient previously took first dose of bnt162b2 (Lot # EL3248) on 03Mar2021 16:30 in right arm for COVID-19 Immunization. The patient experienced pain at injection site on 15Apr2021 17:00 with outcome of recovering, arm pain on 15Apr2021 with outcome of unknown. No treatment received for event pain at injection site. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
55 2021-05-10 pain in extremity first shot, just some soreness of her arm; This is a spontaneous report from a contactable consumer.... Read more
first shot, just some soreness of her arm; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: EM0204) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her first shot on 18Mar2021. She had nothing really with the first shot, just some soreness of her arm. The outcome of the events was recovered on 21Mar2021. No follow-up attempts are needed. No further information is expected.
55 2021-05-11 numbness, tingling, pain in extremity Swelling of joints, left arm numbness, hand numbness, wrist, ankles, knees, elbow swelling, pain, nu... Read more
Swelling of joints, left arm numbness, hand numbness, wrist, ankles, knees, elbow swelling, pain, numbness, bone pain in left arm, tingling in fingers, hand pain. Nausea, dizziness.
55 2021-05-11 pain in extremity Fever 101.9 F with chills that began overnight following 4/17 dose ~5am 8/17/21 and extended until e... Read more
Fever 101.9 F with chills that began overnight following 4/17 dose ~5am 8/17/21 and extended until evening the next day. Muscle aches, pain in arm that subsided after 2 days. **Also acute piercing pain in gall bladder area beginning around 5am, that became less painful after a few hours. Sensitive that next day (4/18/21, then lessened). Some tenderness and sensitivity persists (but NOT piercing or acute) to present 5/12/21 but does not interfere with daily activity...can reposition to lessen discomfort, wear less binding clothes. (Note history of low ejection fraction from 2018/19 evaluation).
55 2021-05-11 seizure immediately after receiving the Pfizer vaccine the patient had a seizure and passed out. once she re... Read more
immediately after receiving the Pfizer vaccine the patient had a seizure and passed out. once she regained consciousness she then had an additional seizure. The ambulance was called and she was taken to the hospital.
55 2021-05-11 unresponsive to stimuli Developed change in mental status and became unresponsive. No SOB. No edema. Was administered O2. 91... Read more
Developed change in mental status and became unresponsive. No SOB. No edema. Was administered O2. 911 called and sent to ER for further evaluation. Patient has fully recovered.
55 2021-05-12 pain in extremity Extreme burning pain throughout my spine within 2 hours after vaccine, then bottom of feet and hands... Read more
Extreme burning pain throughout my spine within 2 hours after vaccine, then bottom of feet and hands were also extremely painful , still having issues with that since vaccine on and off and then today 5/13/2021 I went in the sun for only 5 minutes and my shoulders are Burning and developed a rash on both shoulders within minutes however I had clothes covering the shoulders and you cant even touch the shoulders as they were burning hot ( but just the shoulders ) .. This has never EVER happened to me in my life.. My body has been so off since this vaccine I am miserable.
55 2021-05-14 feeling jittery, restless legs syndrome 5 hours after injection: Headache, Neck Stiffness, Low Back Pain, & Very tired. An hour later my sy... Read more
5 hours after injection: Headache, Neck Stiffness, Low Back Pain, & Very tired. An hour later my symptoms increased: Fever of 101.6 which lasted for 3 hours. Chills, Shivering, Exhaustion. Nausea. After my fever broke, my Legs started Kicking involuntarily,. They kicked Constantly for 2 hours. (It was scary and out of the ordinary.) So much so that my knees hurt. If I forced my lag to stop kicking, my ankles and feet start jittering. If I get up to walk around my feet swell up. I was Still nauseous. I was unable to eat Lunch or Dinner. At bed time I was able to eat a bowl of cereal, and my legs finally stopped kicking. Nausea subsided. Next morning felt achy and had a runny nose. 34 hours after vaccination. felt tired, had chills and nausea again. I had to take a nap. The following day I felt like I was back to normal.
55 2021-05-15 weakness Fever 101 F, chills, headache, body aches, joint aches, very low energy, decreased concentration (to... Read more
Fever 101 F, chills, headache, body aches, joint aches, very low energy, decreased concentration (took 3 days until back to normal)
55 2021-05-15 feeling cold 24 hours after receiving the second dose of the vaccine, I suffered extreme pain in my joints. I ac... Read more
24 hours after receiving the second dose of the vaccine, I suffered extreme pain in my joints. I ached all over, even my knuckles. I had a headache and I was cold. I took one extra-strength Tylenol and one Advil every 4-6 hours. I didn't move for six hours, I was so fatigued and sore. At 9:30 pm, I went to bed. I took another dose of Advil and a dose of NyQuil. I slept till morning. I was still sore when I woke up, but it wasn't as extreme. By noon, I could move around easily and by 5:00 pm, I was feeling almost back to normal. After another good night's sleep, I woke up feeling fine on Sunday, 5/16/2021.
55 2021-05-16 migraine Feeling general body aches, vertigo, chills, fever, and migraines to the point of being unable to wo... Read more
Feeling general body aches, vertigo, chills, fever, and migraines to the point of being unable to work for at least a day so far. Symptoms continue as of this report.
55 2021-05-17 numbness, tingling, electric shock sensation, discomfort 5/7/21 1:15 pm - Couple of minutes after my top lip felt swollen and felt tingling with a slight he... Read more
5/7/21 1:15 pm - Couple of minutes after my top lip felt swollen and felt tingling with a slight headache. Had a bit of dry mouth. 5/8/21 7:30 am. - Heart started racing with elevated blood pressure. Had a headache and fatigue all day. 5/9/21- headache and fatigue. Felt an electrifying sensation upon waking throughout my body. 5/10/21 - left side pressure headache, fatigue. Felt an electrifying sensation upon waking throughout my body. Felt tingling in my face. 5/11/21 - left pressure headache throughout the day then at 9:30 pm my left arm went numb and felt left sided pressure headache with tingling in my face. 5/12/21 - mild headache. Had metal taste in my mouth. 5/13/21. Mild headache 5/14/21 - heart racing with elevated blood pressure 5/15/21 - pressure headache
55 2021-05-17 numbness Patient received the 1st COVID vaccine Pfizer, lot #EW0182 EXP 08/2021 at 2:24 PM in her right delto... Read more
Patient received the 1st COVID vaccine Pfizer, lot #EW0182 EXP 08/2021 at 2:24 PM in her right deltoid muscle. Client alerted EMT in the observation area about 20 minutes into her observation time. EMT responded to the client. Client reported feeling tightness and numbness in her lower extremities bilaterally. Client was to wait in the observation area for 30 minutes due to history of "face swelling" after taking Amoxicillin. The client sought emergency services following this incident, and denies any medications given at the time. Lead RN and Co-lead RN presented to the client at 2:52 PM. The client was escorted to the anti-gravity chair by EMT. Client denied any itching, swelling of her throat, or SOB. No swelling was noted by RN around the patient's face and mouth. Vitals taken by EMT at 2:52PM were as follows: HR: 73, O2 97%, and HR 80. Pupils equal, round, and reactive to light. Client reports a history of hypertension and diabetes mellitus II. Current medications include Aspirin, Lisinopril, Janumet, and Lipitor. She stated that she takes her BP medications in the evening, and hasn't taken a dose since last night. At 2:56 PM, the client was reclined in the anti-gravity chair. Client denied headache, shortness of breath, or chest pain at the time. No erythema/redness or swelling were noted at the vaccination site, right deltoid. Client was offered water at this time. Repeat vitals by EMT at 3:01 were as follows: BP 120/85, HR 73, O2 96%. Physical assessment by RN demonstrated L radial pulse 2+, bilateral pedal pulses 2+. Client stated the "numbness is getting better". Pedal strength equal bilaterally and hand grasp strength equal bilaterally. Client's smile was equal bilaterally. Bilateral pedal capillary refill <2 seconds. Client denies any history of a circulatory disorder or diagnosis. The client reported her last vaccination was a flu vaccination approximately 5 years ago. At 3:04 PM, the client was assisted to a standing position by RN. The client stated she "feels better." Client was then seated again in the anti-gravity chair without assistance. Due to persistent symptoms RN discussed medical treatment options which included calling 911 for further evaluation, or seeking urgent care services. The client declined EMS services and transport to hospital. Client stated she would prefer to seek treatment at a different Hospital with her husband today. Education was provided regarding signs and symptoms of anaphylaxsis, when to seek EMS services, to follow up with PCP within 1 week regarding reaction and BP, V-SAFE. Client voiced understanding of this. Vitals obtained by EMT at 3:11 PM were BP 130/90, HR 76, O2 97%. Client's husband entered the facility. The client and her husband voiced plans to seek services at other Hospital following discharge from the vaccination site. Client was discharged. Client exited the facility with a steady unassisted gait, into a personal vehicle driven by her husband at 2:26 PM.
55 2021-05-17 numbness and pain in extremities (I also had aggravation of existing neuropathy in left foot day of.) At day 10 after vaccine I had f... Read more
(I also had aggravation of existing neuropathy in left foot day of.) At day 10 after vaccine I had full-body hives.; Hives. Minor: I had discomfort, mostly gastro and fatigue for nearly three weeks.; Hives. Minor: I had discomfort, mostly gastro and fatigue for nearly three weeks.; Hives. Minor: I had discomfort, mostly gastro and fatigue for nearly three weeks.; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: EN6208), via an unspecified route of administration in left leg on 13Mar2021 at 16:00 as a single dose for COVID-19 immunization. Medical history included mental health, orthopedic, allergies and existing neuropathy in left foot. Concomitant medications included lamotrigine, OTC paracetamol (Tylenol) and Vitamin supplements which was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had tested for COVID-19, where the nasal swab test was performed on 03May2021 and the result was obtained as negative. On 23Mar2021, the patient experienced discomfort, mostly gastro and fatigue for nearly three weeks also had aggravation of existing neuropathy in left foot day of. It was also reported on day 10 after vaccine she had full-body hives and it was very unusual for her and there was no other obvious cause. At the time of this report event outcome was recovered, on an unknown date in 2021. Information on Lot/Batch number was available. Additional information has been requested.
55 2021-05-19 coordination abnormal racing heart; dizziness; disorientation; blurred vision; forearm muscle pain/lower leg muscle pain; ... Read more
racing heart; dizziness; disorientation; blurred vision; forearm muscle pain/lower leg muscle pain; fatigue; loss of strength and coordination in fingers and arms/ residual arm & leg weakness; loss of coordination.; right lower lip became numb; difficulty with concentration; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the right arm on 26Apr2021 at 02:30 AM as single dose for COVID-19 immunisation. Medical history included lumbar disc degeneration, spinal surgeries x2, stem cell injection (lumbar disc) a little over a year ago, allergies to shellfish. Concomitant medications reported as none. No other vaccine in four weeks. None other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 26Apr2021 at 14:30 PM, (reported as after approx 15 min), racing heart, dizziness, disorientation, blurred vision (inability to focus), forearm muscle pain, fatigue affecting ability to perform my job, loss of strength and coordination in fingers and arms, right lower lip became numb, lower leg muscle pain and loss of coordination. Symptoms that continued to persist after 10 days were right lower lip numbness, difficulty with concentration and fatigue that was affecting my ability to perform my job, and some residual arm & leg weakness and coordination. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Unknown if treatment received for events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
55 2021-05-19 muscle spasms, limb paralysis My left arm is locked in a paralyzed stage where I haven't been able to lift it no more than a few i... Read more
My left arm is locked in a paralyzed stage where I haven't been able to lift it no more than a few inches since the second week that I got the Pfizer shot three weeks ago.; muscle spasm; The left side of my shoulder and neck was stiff; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in arm left on 15Apr2021 at 13:00 (at the age of 55-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included breast cancer, is diabetic and anemic, thyroid disorder, peripheral neuropathy, history of blood clot (reported as 'clog') in leg and pineapple and watermelon allergy, all from an unknown date and unknown if ongoing. On 23Apr2021 at 08:00, the patient's left arm is locked in a paralyzed stage where she hasn't been able to lift it no more than a few inches since the second week that she got the Pfizer shot three weeks ago. The left side of her shoulder and neck was stiff like she had a muscle spasm for about the whole second week. She will not be getting the second shot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures [acetaminophen (TYLENOL), heat on areas, move and rotate areas] were taken as a result of all events. The outcome of the events was not recovered.
55 2021-05-19 muscle twitching, numbness, tingling I had a twinge in my neck as I sat down to wait my 30 minutes and it felt stiff. I noticed my index... Read more
I had a twinge in my neck as I sat down to wait my 30 minutes and it felt stiff. I noticed my index and middle fingers tingling while I grocery shopped (the pharmacy is in a grocery) about 40 minutes later. When I got to my car I saw that the tips of my index, middle and thumbs on both of my hands were turning yellowish. I drove 5 minutes to my next destination and they were turning almost white and were very tingly/numb. By 3:07 all of these fingers were pinking back up except the right index which was starting to turn pink again (I took a photo so that's how I have the time stamp). I also realized that my next was no longer stiff.
55 2021-05-19 pain in extremity Fatigue; Indigestion; chest tightness; Headache; watery eyes; stuffy head; mild fever; flulike aches... Read more
Fatigue; Indigestion; chest tightness; Headache; watery eyes; stuffy head; mild fever; flulike aches; sore arm; Very thirsty; dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no:EN6207), via an unspecified route of administration in his left arm on 10Mar2021 at 15:00 (at the age of 55-years-old) for COVID-19 immunisation. Medical history included overweight and mild hypertension. The patient had no allergies to medications, food or other products. The patient's concomitant medications included lutein, zinc, vitamin C, vitamin D3, tylenol and ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021, the patient experienced sore arm and on the same day she was very thirsty and dry mouth for first 12 hours. On 12Mar2021, the patient experienced headache midday about 36 hours after shot and got progressively worsen until about 72 hours and concurrently she experienced flulike aches, mild fever, stuffy head and watery eyes. On 13Mar2021, the patient had some chest tightness and indigestion. On 14Mar2021, the patient felt fatigue. Therapeutic measures were not taken for events experienced. The clinical outcome of the event headache was resolved. The clinical outcome of other events was resolving. No follow-up attempts are needed. No further information is expected.
55 2021-05-19 pain in extremity With my first shot, my arm became sore 8-10 hours after the injection and stayed that way for about ... Read more
With my first shot, my arm became sore 8-10 hours after the injection and stayed that way for about 24 hours. With my second shot (also in the left arm), I had the same reaction as the first injection; however, about 3 days later I woke up with a large lump under my left armpit. Over the next few days, I had swelling on the left-side of my left breast, swelling under the breast and below the left collarbone. This has been very painful, especially at night when I lay down. During the day, it seems to drain (relieving some of the pressure). As of today, I am 6 weeks out, and I still have some swelling on the outer left of my left breast. The lump under my arm has disappeared and the swelling under my collarbone has gone as well. Now I am dealing with sore muscles in my neck and shoulder on my left-side. I believe this to be because I could not hold my arm in a normal position for a number of weeks. My doctor ordered physical therapy for this issue.
55 2021-05-20 weakness Patient developed severe nausea and vertigo as well as generalized weakness, which started May 5. P... Read more
Patient developed severe nausea and vertigo as well as generalized weakness, which started May 5. Progressed to the point that she was unable to ambulate on her own at home and family called ambulance on 5/8/21 to take her to Health Care facilty. She received IV fluids, meclizine and ondansetron with gradual improvement. Still required walker and assistance by the time of discharge on May 13, 2021
55 2021-05-20 pain in extremity patient had headache, fever, arm pain the next day after vaccine but then 7 days later at 2 am she b... Read more
patient had headache, fever, arm pain the next day after vaccine but then 7 days later at 2 am she began to develop urticaria throughout body, mouth swelling and felt pressure on throat (minimal), eyes were swollen when she woke up this morning
55 2021-05-20 tingling Patient came to conference room shortly after receiving her first dose of the Pfizer vaccine with co... Read more
Patient came to conference room shortly after receiving her first dose of the Pfizer vaccine with complaints of tingling in her face and said she felt like she was going to pass out. She denied chest pain, shortness of breath or difficulty swallowing. She was alert to time, place, and event. Her skin was normal color and warm to touch. Upon questioning her she said she was nervous about getting the vaccine and had only had coffee this morning, but nothing to eat. Staff began obtaining her first set of vital signs and asking about medical history. She denied diabetes but said she did have high blood pressure but did not take medication (she said her normal BP was 140s/85-95). We gave her water and saltine crackers to see if her symptoms would resolve. After a few minutes she said she was still having the same feelings, though they had not gotten worse. At this time I checked her vital signs and conferred with staff. We encouraged her to seek further treatment and be transported to the emergency department via EMS. Patient refused ambulance and said she would have her husband drive her (he was in the room with us at this time and agreed to take her to local emergency department). We transported patient to her vehicle via wheelchair. Staff called ED and gave report of these events to one of the ED nurses. I told her husband we would reach out later today to follow up with the situation.
55 2021-05-21 flushing Developed red, facial flush and sweated 15 minutes after 1st dose. Resolved same evening. Developed ... Read more
Developed red, facial flush and sweated 15 minutes after 1st dose. Resolved same evening. Developed small number of hive-like sores (2-days later) on anterior neck, upper abdomen and one on the back. One sore still remains on front of his neck as of 5/22/2021.
55 2021-05-21 flushing Lightheaded and dizzy 5 minutes after vaccination. Assisted to cot legs elevated. Ice pack given w... Read more
Lightheaded and dizzy 5 minutes after vaccination. Assisted to cot legs elevated. Ice pack given water given. Flushed. After 2 attempts approximately 15 minutes apart of trying to sit/stand with dizziness returning, EMS was called. Attendee has a history of pre-diabetes. EMS arrived and Blood Glucose was 311. Refused EMS transport, husband reported to staff that he was going to take her to the Emergency Room himself.
55 2021-05-21 grand mal seizure She aspirated and she was dead within week on respirator; she aspirated and she had pulmonary proble... Read more
She aspirated and she was dead within week on respirator; she aspirated and she had pulmonary problem to begin with; 3 convulsions within 24 hours of having her first Pfizer / three grand mal compulsive seizures; This is a spontaneous report from a contactable physician. A 55-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported, vaccinated at the age of 55 years old) as single dose for covid-19 immunisation. Medical history included epilepsy, myocardial metabolism disorder. She has a myocardial metabolism disorder, very specific one and it is A467T mutation in the polymerase gamma gene and that is because of her epilepsy. It was because of that it's a progressive disease get involved with many part of the body that is all so causes seizure. Concomitant medications included clobazam; lamotrigine; escitalopram; amitriptyline; calcium folinate (LEUCOVORINE); lorazepam; mesalazine; butalbital, caffeine, paracetamol (FIORICET); vitamin b2 [riboflavin] (VITAMIN B2 [RIBOFLAVIN]); ubidecarenone (COQ10 [UBIDECARENONE]); l-carnitine [levocarnitine]; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]); vitamin a [retinol]; vitamin c [ascorbic acid], all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulphur, nepatop, dilantin [phenytoin], prednisone, and lidocaine and all experienced hypersensitivity. The patient had received 3 convulsions within 24 hours of having her first Pfizer and she had epilepsy like she has been suffering from years and she aspirated and she was dead within week on respirator. She had three grand mal compulsive seizures and because of the seizures; she aspirated and she had pulmonary problem to begin with. She was put on a respirator and she was on respirator from the day she was admitted and she probably died within about two days. when the vaccination was, precise 24 hours later she had three grand mal compulsive seizures and because of the seizures she aspirated and she had pulmonary problem to begin with. She had 3 convulsive seizures that stayed for about 10 minutes and she had not, she normally would have the focal seizure just in her left arm. She has not had it big seizure in probably 20 years. The physician stated that don't know what killed her was not seizure when she wasn't he hospital she was intubated and she was alive. What killed her was she was aspirated and they could not get her off the respirator and she did not have COVID. When she was admitted to the hospital they did a lot of blood test. Before that, her cortisone level usually runs about 200, with metabolize of 700, and her lamotrigine level runs about between 4 and 8.5 of all other routine her Full blood count (CBC) routine is quite normal. It was not reported if an autopsy was performed. Outcome of events Grand mal seizure and Pulmonary disorder was unknown. Information on batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported seizures along with the consequent aspirations which lead to death and the use of BNT162B2 cannot be fully excluded. However, it is noted that the patient has multiple comorbidities which confound the reported drug event pairs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: She aspirated and she was dead within week on respirator
55 2021-05-21 numbness First developed numbness/tingling and sensation of tightness/pressure in the left parietal area of ... Read more
First developed numbness/tingling and sensation of tightness/pressure in the left parietal area of my head. About an hour later noticed tightness/pressure in a muscle in my mid to upper, left back. These sensations have continued. A week later I developed numbness and tingling in the left side of my face/jaw. These episodes have also continued to date. There was also an episode in the early morning on 4/21 when I had uncontrolled, extremely painful spontaneous muscle contractions in my lower left leg, involving a few different smaller muscles. About May 2nd, the muscles in my left hand near the base of my thumb began to involuntary/spontaneously contract. This happened a few times over several days.
55 2021-05-23 migraine with aura Migraine with aura following 10 days of pulsating headache
55 2021-05-24 numbness, throat numbness On 04/15/2021 in the evening around 8pm I started feeling very tired and sleepy. My left side from t... Read more
On 04/15/2021 in the evening around 8pm I started feeling very tired and sleepy. My left side from the top of my head all the way to my left side of my leg felt numb and painful. My left side of throat felt numb, too. I felt dizzy and wanted to go to sleep.
55 2021-05-24 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
55 2021-05-25 numbness, burning sensation tiredness; pain on the back of head; Nausea; numbness in my face around my checks, nose, and mouth a... Read more
tiredness; pain on the back of head; Nausea; numbness in my face around my checks, nose, and mouth area; felt a burning sensation down my left arm; dizziness; heaviness on the back of my neck and head,; body aches; pain on neck; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration, administered in the left arm on 14Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included shrimp allergy and allergy to sulfa mediations. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to vaccination. On 14Mar2021. the patient experienced tiredness, pain on the back of head and neck, nausea, numbness in face around my checks, nose, and mouth area, felt a burning sensation down left arm, dizziness, heaviness on the back of my neck and head, and body aches. No treatment was given for the events. The clinical outcomes of experienced tiredness, pain on the back of head and neck, nausea, numbness in face around my checks, nose, and mouth area, felt a burning sensation down left arm, dizziness, heaviness on the back of my neck and head, and body aches were not recovered. No follow-up attempts needed. No further information expected.
55 2021-05-25 numbness, tingling Persistant digestive problems (diarrhea for first two mornings, followed by gas, bloating, pain, ind... Read more
Persistant digestive problems (diarrhea for first two mornings, followed by gas, bloating, pain, indigestion) peaking after about 5 days and gradually subsiding after about 18 days, accompanying fatigue, occasional brief & mild dizziness,. Also occasional mild tingling/numbness of left fingertips for first few days.
55 2021-05-25 pain in extremity Received vaccine and the following day she had severe left arm pain (vaccine site) lasting 1 week, E... Read more
Received vaccine and the following day she had severe left arm pain (vaccine site) lasting 1 week, Extreme exhaustion lasting 1 week, and brain fogginess lasting 2 days.
55 2021-05-25 pain in extremity Client received the 1st dose of Pfizer COVID vaccine (lot # EW0182 and expiration date 5/15/21) at ... Read more
Client received the 1st dose of Pfizer COVID vaccine (lot # EW0182 and expiration date 5/15/21) at 2:47pm. Client walked over to EMT to report that she was having pain on the opposite arm where vaccine was given and that she would like her blood pressure taken (vaccine given in left arm, pain in right arm). PHN finds patient alert and oriented x 4 sitting in a chair. Client reports she had been waiting 20 minutes in observation. Client reports a history of hypertension. Per client, she was not sure about taking her nifedipine, so she did not take her medication at the regular time. Client states she takes Losartan and took it this morning. Client denies any chest pain, headache, blurred vision, dizziness, or shortness of breath. At 3:14pm vitals: blood pressure:173/103, pulse:60, and oxygen: 98%. At 3:20pm vitals: blood pressure:161/106, pulse:60, and oxygen:99%. Client reports no symptoms. PHN came to speak to client and patient reports she has her medication with her and took it out of her purse. Client thought she should not take medication because she was getting the vaccine. Client also stated when she does not take her medication 160-180 systolic is her regular blood pressure at home. PHN let client know that she should take medication as prescribed. Client took 2nd dose of hypertension medication (Nifedipine) at 3:24pm. PHN recommended client to stay for further observation as blood pressure is high. At 3:25pm vitals: blood pressure:155/94, pulse:63, and oxygen:99%. Client reports no more arm pain on right arm and that "she was a little nervous about the vaccine and that her blood pressure goes up easily.". At 3:30pm vitals: blood pressure:160/99, pulse:66, and oxygen:98%. Client reports she is feeling better and was provided with ER precautions and to notify her provider about her blood pressure readings. Also recommended client eating and taking medication prior to dose #2. Client reports no shortness of breath, no headache, no arm pain, no chest pain, no blurred vision. At 3:38pm, vitals are: blood pressure: 152/99, oxygen:99, and pulse:60. Client reports no symptoms. At 3:44pm vitals: blood pressure: 148/99, pulse: 60 and oxygen: 98%. Client walked out with a steady gait at 3:46PM.
55 2021-05-25 tingling This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0183), via an unspecified route of administration in right arm, on 14May2021 at 10:00 (at the age of 55-years-old) as first dose, single for COVID-19 immunization in a hospital. Medical history included rheumatoid arthritis, asthma, hypertension and medullary sponge kidneys. The patient had known allergies. The patient had concomitant medications but not reported. The patient was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient's both feet feel like having pins and needles and feel asleep on 14May2021 at 10:45. No treatment was received by the patient for these events. The outcome of these events was not recovered at the time of report. No follow-up attempts are possible. No further information is expected.
55 2021-05-26 bell's palsy Bells Palsy right side of face, symptoms started within 1 hour of injection.
55 2021-05-26 breast pain, tingling, pain in extremity, numbness her hormones were over the top; soreness in her back/ It hurt and at times felt numb; No period in m... Read more
her hormones were over the top; soreness in her back/ It hurt and at times felt numb; No period in months. 2 days after the vaccine she ovulated; Soreness in back; Arm hurt really bad; Sensation of not feeling right; Skin feels like it's burning; body felt like it's vibrating; Ache in injection site; Pre-menstruation symptoms of sore breasts; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration, administered in right arm on 13Mar2021 at 14:00 (at 55-year-old) at dose 1, single dose for COVID-19 immunisation. Medical history included ongoing peri-menopause, she had off and on been having peri-menopause for at least 3 years. Patient reported that it has been this past year since she hasn't had a period and she thought she was done; ongoing hypertension, she was controlling her hypertension with food, specifically no salt. Patient reported that it makes her feel better when avoids salt. Patient reported that she was diagnosed with hypertension probably 4 years ago in 2017; ongoing asthma, she felt like sometimes she had asthma but it's seasonal; ongoing congenital heart defect, diagnosed when she was a baby; when patient got a period, she got anemic. She's high-risk; COVID-19 vaccine was recommended to her. None family medical history relevant to the events. There were no concomitant medications. The patient previously received flu shot in 1991 (reported as 30 years ago) and experienced that her arm got swollen and red and that the doctor had her come back in to look at her and stated that it looked like she was having an allergy to the egg in the vaccine. No Prior vaccinations within 4 weeks. The patient had no period in months. 2 days after the vaccine on 15Mar2021 she ovulated. She also reported having pre-menstruation symptoms of sore breasts in Mar2021. She was concerned about getting a period, as it made her anemic. Patient reported that she has been experiencing peri-menopause for the last year and hasn't had a period in 10 months. Patient reported that the Covid-19 vaccine has triggered her period and that her hormones were over the top. Patient reported that she was scheduled to get her next dose of the Covid-19 vaccine on 02Apr2021 and because she was having all those hormone experiences, she was unsure how to navigate this next shot. Her doctor was aware of what she was experiencing and that she didn't know what her physician can do. Patient reported that she has not yet had a period, but that it's coming, definitely coming even though she hasn't gotten it yet. Patient reported that if she does have her period she needs to go in to see her physician. Patient reported that while she hasn't had her period yet she has all of the symptoms that her period brings. Patient reported that she hasn't had these symptoms in 10 months. Patient reported that her boobs hurt and that she can't even touch them because they hurt so bad. Patient reported that she has had some weird things and that she was going back and forth with her doctor. Patient reported that she hasn't been to the doctor in a year and a half. Patient reported that she was afraid to go to the doctor and that her doctor was trying to evaluate her symptoms over the phone. Patient reported that she was getting frustrated as she didn't want to get the Covid-19 virus going to the doctor's office. The patient experienced arm hurt really bad on 13Mar2021. Patient reported that immediately after receiving the first dose of the Covid-19 vaccine, her arm hurt really bad. The patient experienced soreness in back on 15Mar2021. Patient reported that the pain from her arm the next day went into her back. Patient reported that she was having back pain for probably a good week after. Patient reported that her back pain has calmed down. Patient reported that she then started having a sensation of not feeling right in Mar2021. Then she was having pre-menopausal things that started probably 3 days after vaccine on 13Mar2021. She still had a sensation in her arm, that every once in a while her arm will ache. Patient reported that she had the pain in her arm for 2 days and that the pain then went into her back in between her shoulder blades. The back pain felt like someone was punching her in the back and she felt most winded. The sensation in her arm was like a dull ache in that spot, the injection site, and that she wanted to rub or put heat on it. Patient reported the soreness in her back was like pressure in her back. It hurt and at times felt numb. It hurt to the point where it felt like it was knocking the wind out of her. It was like the pain from her arm moved to her back. The back pain was not as bad, that it's calmed down a little bit. Her boobs hurt so bad but she didn't know if that's correlated to the Covid-19 vaccine. The breast tenderness started about a week ago, maybe 20Mar2021. The breast pain was ongoing but that it comes and goes. There are times where the breast pain has gotten worse and times where it's gotten better. When she woke in the morning the breast pain was worse. Once she started moving around the breast pain kind of went away but later in evening got really bad. She felt like her body was fighting the hormones to have a period and that she would feel a hundred times better if she got her period. Apparently her physician doesn't want her to get a period. The patient experienced sensation of not feeling right in Mar2021. Patient reported that the sensation of not feeling right started like a week ago, that there was week in between getting the Covid-19 vaccine and when she started experiencing weird things. She has talked to some people that have reported they have not had any side effects following the Covid-19 vaccine. Patient explained that the vaccine has just triggered so much in her, she was just frightened because everybody said the second dose was the worse. Patient reported that her doctor kept saying to give the side effects some time, maybe they'll settle down, but they haven't. All of her symptoms kind of gradually came a few days to a week after receiving the Covid-19 vaccine. The patient experienced skin feels like it's burning in Mar2021. Patient reported that she never felt like she was going to jump out of her skin, but the skin burning was an annoying feeling, like a sunburn. The patient experienced body felt like it's vibrating in Mar2021. Patient reported that she developed this symptom a week to a few days after receiving the Covid-19 vaccine. It was not a constant thing but when she was sitting still she felt it. The patient experienced ache in injection site in Mar2021. Patient reported that her right side, which was the same side that she received the first dose of the Covid-19 vaccine, was the side she was having back pain and that she had more pain in her right breast. Her doctor recommended that she get the second dose in the other side, her left arm. She did not take any medications. Patient reported that she has not had any relevant tests done but that she didn't know if she should or not. She doesn't know if how she is feeling now will impact if she should get the second dose of the Covid-19 vaccine. If she didn't feel a thing, she would go ahead and get that second dose, but because she has so many things going on, she's wondering how it is going to effect her. She was not sure if she should push out the date for the appointment for her second dose of the Covid-19 vaccine. For her, if she pushes out the second dose of the Covid-19 vaccine for a week, it might help her recover from the first dose. She definitely wanted to complete the series of vaccines for Covid-19, but she didn't want to die from this shot either. Patient reported that her second dose of the Covid-19 vaccine was originally scheduled for the 01Apr2021 and that she rescheduled the appointment to hopefully get the second dose Saturday, 03Apr2021. The events did not require a visit to emergency room or physician office. The outcome of events pre-menstruation symptoms of sore breasts, sensation of not feeling right, skin feels like it's burning, ache in injection site, body felt like it's vibrating was not recovered; outcome of event arm hurt really bad was recovered on 15Mar2021; outcome of event soreness in back was recovering. The outcome of the other events was unknown.
55 2021-05-26 tingling Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported tingling sensation in hand after administration of vaccine, she has some pre-existing nerve issues relating to carpal tunnel syndrome on both sides, followed-up with patient later in the evening (~7pm), and she stated she felt a little dizzy when doing some computer work and stopped, but that her tingling sensation was subsiding. She was previously instructed to contact her primary care doctor, which she did, and she plans to follow up with the office the morning.
55 2021-05-27 numbness Numbness in her arm and hand,Headache
55 2021-05-28 burning sensation Severe burning sensation in left forearm with shot one, shot two. Severe burning Left side of vagin... Read more
Severe burning sensation in left forearm with shot one, shot two. Severe burning Left side of vaginal area next to inside of left leg (PUDENDAL NERVE) with shot two
55 2021-05-28 involuntary muscle movements When I pucker my mouth, like when blowing out a candle only one side of my mouth puckers out. I tho... Read more
When I pucker my mouth, like when blowing out a candle only one side of my mouth puckers out. I thought I had a stroke.
55 2021-05-28 muscle spasms post menopausal bleeding , Cramping after 4 years of stopped cycle
55 2021-05-29 numbness 39 days after the 2nd Pfizer shot I had numbness in my left calf and foot. One weak after that I lo... Read more
39 days after the 2nd Pfizer shot I had numbness in my left calf and foot. One weak after that I lost most feeling in my legs ( I can move both but cannot walk unassisted with them not giving out. Went to the ER and had an MRI which said minor L3 L4 narrowing but no herniated disc.
55 2021-05-31 feeling hot, pain in extremity Red rashes over swollen area of injection site; Red rashes over swollen area of injection site; Itch... Read more
Red rashes over swollen area of injection site; Red rashes over swollen area of injection site; Itching over swollen arm; itching over other parts of body; itching over other parts of body, warm to touch; Swelling at the injection site; Warm on the injection site; knot at injection site; Slight arm pain; Elevated blood pressure; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, strength: 0.3 mL, Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 12Mar2021 at 09:30 (at the age of 55-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Medical history included Type II Diabetes; High Blood pressure (usually maintained by medication); low iron anemia, migranes; lichen planus; detached retina; prior to vaccination, patient was diagnosed with COVID-19. Other concomitant medications were received within 2 weeks of vaccination. The patient's known allergies included ciprofloxacin (CIPRO) (Highly allergic), moxifloxacin hydrochloride (VIGAMOX) and moxifloxacin hydrochloride (AVELOX), all experienced allergies. Slight arm pain evening of vaccination date on 12Mar2021 at 21:15. Small knot at injection site and arm pain following two days from 13Mar2021, larger knot at injection site and arm pain third day and arm pain, with warm to area to touch by late evening on 14Mar2021. By morning of fourth day (15Mar2021) area of injection site swelling three to five times more than evening before (14Mar2021), red, slight rash over swollen area, arm pain. By afternoon on 15Mar2021 itching where arm was swollen and continues to swell, and itching over other parts of body, warm to touch. NO fever during any of this time. Elevated blood pressure on 12Mar2021 at 21:15. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient was not tested for COVID-19. No treatment was received for events. The outcome of the events was not recovered. The report was reported as non-serious. No follow-up attempts are needed. No further information is expected
55 2021-05-31 numbness, tingling Right arm experiencing pins and needles all the way up to the chest. Itching on the same arm but no... Read more
Right arm experiencing pins and needles all the way up to the chest. Itching on the same arm but no sign of rash. Sensitivity to heat, cold, water and clothing. Mild visible lump on wrist. Mild numbness of arm/hand while walking. 24 hours of symptoms even while sleeping. symptoms moving toward middle of chest.
55 2021-05-31 pain in extremity Rash on left forearm; Chills; swollen lymph nodes; Sore right arm; This is a spontaneous report from... Read more
Rash on left forearm; Chills; swollen lymph nodes; Sore right arm; This is a spontaneous report from a contactable other hcp (patient herself). A 55-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 29Jan2021 at 13:30 (at the age of 55-years-old) as a single dose for covid-19 immunisation. Medical history included first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown) administered in left arm on 08Jan2021 (at the age of 55-years-old) 13:30 for covid-19 immunisation, hypothyroidism, GERD, and unspecified allergies. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication received within 2 weeks of vaccination on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 30Jan2021 at 12: 00 AM, the patient experienced, Chills, swollen lymph nodes, Sore right arm, Rash on left forearm on day 4 and 5 post 2nd vaccine. No treatment was received for adverse event. The reporter assessed adverse events as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of the events was not recovered. Information on the lot/batch number has been requested. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
55 2021-06-01 burning sensation approximately 2 weeks after each vaccination she developed a localized burning rash of the bilateral... Read more
approximately 2 weeks after each vaccination she developed a localized burning rash of the bilateral buttocks, and patchy areas of the extremities, seen by urgent care than primary doctor then referred to my clinic in Dermatology. She was treated with topical steroids and prednisone, when the rash occurred after the 2nd vaccination I did perform a punch biopsy, and this showed a dermal hypersensitivity reaction, both the biopsy findings and the timing of this rash occurring in same distribution after the each vaccination approximately 14 days I do think this is a vaccine triggered hypersensitivity phenomenon with a localized clinical appearance looking like dermal hypersensitivity.
55 2021-06-01 numbness, muscle spasms, tremor, feeling hot, tingling Elevated blood pressure; heart rate was 125; thyroid is low; very sick; panic attack; chest is tight... Read more
Elevated blood pressure; heart rate was 125; thyroid is low; very sick; panic attack; chest is tight; irritable and having mood swings; anxiety or panic attack; irritable and having mood swings; pounding head; nausea; horrible body aches; Cramps; Shaking; shivering; gets violently hot; sweating profusely; arm turned dark red, went numb and tingly; arm turned dark red, went numb and tingly; arm turned dark red, went numb and tingly; blood in the urine; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 (Batch/Lot Number: ER8736) as 2nd dose, single for covid-19 immunisation. Medical history includes post-menopausal. The patient has a family history of low thyroid (mother). Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA-D 12HR) taken for an unspecified indication and paracetamol (TYLENOL EXTRA STRENGTH) taken for pain, start and stop date were not reported. The patient previously received first dose of Bnt162b2 on 13Apr2021 (lot number: ER8729) in the left arm for Covid-19 immunization. After she got the second dose in May2021, she did get very sick for about 48 hours, with a pounding head, nausea, and horrible body aches, cramps and shaking. She clarifies these symptoms lasted for about 24-48 hours. She has been much, much, much worse now since the second dose. It looks like some things were thrown off in the blood tests and stuff that were done in the ER. It's even showing that her thyroid is low and they immediately put her on Synthroid thyroid medication which made her a little nervous. She is not sure that what is showing up is something that is systemic with her or if this is something effecting what is systemic with her or if she is having some reaction. She is a little terrified right now to have her heart rate and blood pressure be up so much all the time. The level it was on Friday (209/100) scared her to death. Last Friday, after she took a shower, she was feeling like she was going to die. She does not know how else to explain it. She does have a blood pressure cuff and she decided to take her blood pressure. Her blood pressure was 209/100 and her heart rate was 125. Her blood pressure has been hovering around the 160s and 170's for the top number. She explains she and her doctors cannot get her to calm down. She called her doctor and she was sent to the Emergency Room. Some of the heart palpitation stuff and other things is coming in waves, it's not like its constant. But the blood pressure being elevated is constant. Also, when she has these waves, she also has perfused sweating. The waves last for about 5 minutes and the perfuse sweating takes a long time to stop. Her body is wet and she is instantly drenched. She is post-menopausal for like 2 years, it's not like hot flashes or anything weird showing up at the same time. She feels like she is in the middle of some sort of panic or anxiety attack 24 hours a day. She is also experiencing a lot of shaking and shivering. All of sudden, she gets violently hot and starts sweating profusely until she is drenched. She wakes up drenched in the middle of the night with her heart beating and high blood pressure, it wakes her up violently in the middle of the night. These symptoms have been continuing the entire time and she thinks it is getting worse. Friday was the highest her blood pressure has ever been. When she tried to use blood pressure cuff, her arm turned dark red, went numb and tingly, and she had tons of pain. She thought her arm was going to explode. She has never had that happen. She thinks the blood pressure was so high that the cuff caused that to happen. This made her think her blood pressure was close to heart attack level. Her blood pressure was 209/100 and her heart rate was 125. Her arm had never done that before. She clarifies she only went to the emergency room and she was never admitted into the hospital. She tried to get them to admit her because this has been going on so long and it's not correcting itself but they did not want to admit her. Clarified she went to the ER on Friday 14May2021. Several things were showing up weird in her blood tests. One of the things that showed up was that her thyroid was slightly low. She clarifies the TSH level was elevated, which meant hypothyroidism (thyroid is low). She was immediately put on Synthroid even though she was telling the doctors she was not so sure if what was happening to her was systemic and that it may be something that is exacerbated by or caused by the vaccine. She had to call into an endocrinologist because wanted her to see the endocrinologist immediately. In the hospital, her heart rate was okay while she was there, this kind of goes in waves. A wave of her heart beat going really, really hard and really, really fast. She states "you can see it through my clothes". The sweating starts at the same time. However, on the regular, like at the time of report, she has been shaking and she can tell her blood pressure is elevated. She has taken her blood pressure twice this morning and it was in the 180s over 90s range and then in the 160/80's range. Constantly, she feels like her heart is racing around and her blood pressure is racing all day long. It feels like what an anxiety attack would feel like. It's like she just can't get her body to calm down. Her heart rate calms down a little bit, she is constantly hearing the pounding in her ears when her heart beats. She is just riled up all of the time and her chest is tight. It's not like a breathing issue, her body is just tight, it feels like when she is scared or alarmed. She also has become very irritable and having mood swings. She thinks that is more coming from her body feeling like her body is on high alert or overly sensitive. It feels like every little thing is gigantic. She has never felt that before. She is normally a fully high functioning person. Because her blood pressure is so high and this isn't stopping. She is literally debilitated and cannot function. The patient underwent lab tests and procedures on 14May2021 which included albumin globulin ratio: 1.1, lowest of recommended low, anion gap: 5, slightly low, blood glucose: 111, elevated, potassium: 3.4, slightly low, blood pressure measurement: 209/100, blood thyroid stimulating hormone: 3.820, slightly elevated (low thyroid), globulin: 3.9, slightly elevated, heart rate: 125, platelet count: 448, slightly elevated, protein total: 8.2 (right at recommended normal high level), blood UA positive 1+ and blood pressure measurement: 171/101; heart rate: 109 both on 17May2021. The patient added that her endocrinologist ran all of her tests last Sept2020 and her thyroid was not even an issue. Some traces of blood in the urine was found in blood UA. Nothing that should be causing that because there is no menstrual cycle or anything else they know is going on. The outcome of event chest tightness was not recovered; all other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
55 2021-06-01 tenderness Headache; Fever; Chills; I am aching; Little tenderness in my left cap, feels like little bruise; Li... Read more
Headache; Fever; Chills; I am aching; Little tenderness in my left cap, feels like little bruise; Little tenderness in my left cap, feels like little bruise; This is a spontaneous report from a contactable consumer or other non hcp. A 55-years-old female patient received the first dose of BNT162B2 (Formulation: solution for injection; Batch/Lot Number: EW0177) via an unspecified route of administration on 18May2021 (at age of 55-years-old ) as a single dose for COVID-19 immunization. Medical history included COVID-19 in Mar2020. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. On 19May2021, the patient experienced headache, fever, chills, i am aching and little tenderness in my left cap, feels like little bruise. The patient woke up this morning with the terrible headache and took 2 Tylenol in the morning then took 2 Tylenol in the afternoon. So, the patient haven't had any Tylenol since about 2 o clock this afternoon and the patient had a fever now. The patient just didn't expect to feel sick after the first shot, the girl who administered the vaccine asked me if the patient had COVID before and the patient had COVID in Mar 2020, so she said some people who previously had COVID experience side effects after the first shot. The patient was concerned because still (on day of reporting) had really bad headache and fever and the chills and was aching. The patient took Tylenol and went to bed, drink water. The patient also had little tenderness in left cap, felt like little bruise. The outcome of events was unknown. Information on Lot/batch number is available; Further information has been requested.
55 2021-06-01 tremor it is freaking burning; open wound; Soreness; Little blister; She stated her whole body was shaking;... Read more
it is freaking burning; open wound; Soreness; Little blister; She stated her whole body was shaking; Skin falling off/It got like an open area besides my pinky on the left side of my face next to my left eye; Exhausted; I had diarrhea.; I had headaches/It has caused a extreme headache.; Shingles in my eyeball/stated her shingles were coming out. She felt like the Shingles were coming through her shoulder blade and 6 days after the shot her shingles were coming out of her left eye.; I have been getting chills since shot two.; This is a spontaneous report from a contactable consumer. This 55-year-old female consumer (patient) reported that. A 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 03May2021 13:52 (Batch/Lot Number: ER8730) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included shingles, ongoing asthma and breathing. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for dyspnoea, fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for dyspnoea. The patient previously took first dose of bnt162b2, administered in left shoulder on 12Apr2021 (Lot number: Lot number: EN6208) for covid-19 immunisation and also took breo and experienced shingles. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she took Valacyclovir which is like Valtrex because of shingles coming out my eyes and took a painkiller it's a naproxen painkiller for headache during the day since may 4th. She also took Symbicort and Advair for like top of the years now because of my breathing. Dose of Valtrex was stated by the consumer as 1000 mg (Not confirm hence not captured). The patient reported Last night, I had diarrhea and I woke in a little while with chills and this morning I woke up with more of my, more of the skin fell of my face and the worst thing is like that. She stated she felt soreness, a little bit of a headache coming and her shingles were coming out. She felt like the Shingles were coming through her shoulder blade, 6 days after the shot her shingles were coming out of her left eye and went on for two weeks, she thought it was gone and then they came back. She stated that she was looking at on her skin; it was falling off and it was freaking burning. She has an open area the size of her pinky for 3 days now. She reported that her skin is coming off her her left side of her face, clarified right next to her left eye. Diarrhea started 04May2021 and it comes and goes. She also mentioned she woke up with chills last night. She clarified the chills came on shortly after the shot on 04May2021 and went away. She stated her whole body was shaking and she did not had chills like this since she can remember. She was an hour and half late for work because she was so exhausted A section of skin fell off her face. Caller mentioned the shingles in her back were coming out on 04May2021. She took Valtrex she had leftover from before. She stated she had shingles in her eye ever since she took the product called BREO. Sunday, 6 days after she received the second shot, she felt the shingles coming out of her left eye. She went to see her doctor because she was out of Valtrex and he gave her more Valtrex to take. The vaccine pushed the shingles out and made it open up, initially on her back the day she got the second shot. The skin falling off her face started 22May2021. She developed a little blister that fell off. Yesterday the skin also came off. This morning another section of her skin came off. She clarifies there was another bubble that was attached to her skin. The area of her face was an open wound. She took Naproxen to control her headache, at night occasionally she took a nerve block and Singulair and Advair for a couple of years depending on her asthma and allergies. Therapeutic measures were taken as a result of i had headaches/it has caused a extreme headache and Shingles in my eyeball/stated her shingles were coming out. She felt like the Shingles were coming through her shoulder blade and 6 days after the shot her shingles were coming out of her left eye. The outcome for the event diarrhoea, skin falling off/it got like an open area besides my pinky on the left side of my face next to my left eye, it is freaking burning, open wound, soreness, little blister and she stated her whole body was shaking was unknown, for the events i had headaches/it has caused a extreme headache, shingles in my eyeball/stated her shingles were coming out. she felt like the shingles were coming through her shoulder blade and 6 days after the shot her shingles were coming out of her left eye, i have been getting chills since shot two and exhausted outcome was not resolved. No further details provided or obtained. Information on Lot/Batch number was available. Additional information has been requested.
55 2021-06-02 weakness Pt. complains of dizziness and weakness. She has a hx of hypertension and diabetes and advised she ... Read more
Pt. complains of dizziness and weakness. She has a hx of hypertension and diabetes and advised she had not really eaten before vaccine. Pt. went home w/ son. Vitals spO2 99%, BP 167/85, HR 65.
55 2021-06-02 flushing 5-4-21 11:15AM; feeling flushed, taste of rubbing alcohol on tongue, sinus pressure, nose bleed. Fol... Read more
5-4-21 11:15AM; feeling flushed, taste of rubbing alcohol on tongue, sinus pressure, nose bleed. Followed by nose bleeds with blowing nose. Tongue turned blotchy white 4-13-21 approx. 11:30AM; taste of rubbing alcohol on tongue.
55 2021-06-02 pain in extremity, feeling hot, nerve pain 5/19 - Left side body pain. Nerve pain. localized to rib area. 5/20 - Left side body pain. Nerv... Read more
5/19 - Left side body pain. Nerve pain. localized to rib area. 5/20 - Left side body pain. Nerve pain. localized to rib area. Took some curcumin at lunch and pain went away for 5-7 hours and returned in the evening. 5/21 - In addition to left side nerve pain, woke up with right leg nerve pain. Localized to side of my right leg. Just a couple inches above the knee on the external side of my leg. I took curcumin at lunch and then again in the evening. Pain went away completely for my left side and my right leg. 5/21 - Elevated temperature. I would periodically break out into a sweat and then it would go away. I took my temperature and found it was slightly elevated. I normally run 97.5 or so. It was 98.9 when I took it. It would pass quickly (but it would happen if I was just sitting and working). 6/2 - Ankle swelling. Both left & right ankles swollen. Slept with legs elevated. It has been warm, but I have never had a problem with swollen ankles. 6/3 - Swelling was reduced on both ankles when I woke up on 6/3. As the day went on, left ankle is swollen. Right ankle is fine.
55 2021-06-02 pain in extremity Very sore arm for approx. 48 hours; This is a spontaneous report from a contactable consumer (patien... Read more
Very sore arm for approx. 48 hours; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported; unable to locate or read the details) via an unspecified route of administration, administered in arm left on 04Feb2021 13:30 as first dose, single for COVID-19 immunization (at the age of 55-year-old). Medical history included known allergies to penicillin from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported (as other medications in two weeks). No other vaccine in four weeks, no covid prior vaccination, no covid tested post vaccination. On unspecified date Feb2021, the patient experienced very sore arm for approximately 48 hours and after 2nd dose, slept for most of day. The patient not received treatment. The outcome for event was resolved on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
55 2021-06-02 pain in extremity Epstein Barrs flare up /swelling of her lymph glands/signs were lymph gland swelling, ear pain, and ... Read more
Epstein Barrs flare up /swelling of her lymph glands/signs were lymph gland swelling, ear pain, and throat was sore; a flare of lupus/on the right side of the heart, sharp pain after the vaccine that is indicative of lupus; liver pain; 101 fever /Typical 103 fever; increased fatigue; soreness in arm; This is a spontaneous report initially from a contactable consumer (the patient), and then from the same contactable consumer via a Pfizer sponsored program . A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164) via an unspecified route of administration on 22Apr2021 09:00 at age of 55-year-old at single dose for COVID-19 immunisation. Medical history included autoimmune issues, allergies, ended up on disability related to her lupus and autoimmune issues, chronic sinusitis, lupus, mixed connective tissue disease, autoimmune chronic sensitivities to drugs and food, immunocompromised. The patient's concomitant medications were not reported. The patient had previously taken the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) on 01Apr2021 10:00AM at age of 55-year-old for COVID-19 Immunization, she didn't have any negative effects either reporting that she actually had an improvement in her health after taking the vaccine, she noticed her allergies and her immune system had calmed down the same day (after taking the vaccine she "felt great" reporting that her allergies and immune issues appear to have improved), she got the first shot at 10 AM in the morning. She noticed that evening, she normally had chronic sinusitis. Basically, she had lupus and mixed connective tissue disease and psoriatic arthritis and autoimmune chronic sensitivities to drugs and food. She had fatigue and mental fog all the time. She clarifies at 9 that evening that the first dose was given she could breath and she didn't have allergy problems, she didn't feel fatigue, she slept soundly which was unusual for her. she usually was in a lot of pain and she noticed for the next 9 days all of her hypersensitivity and allergies were gone, she felt good, she had energy it was like she took and magical allergy pill that knocked everything out, she could breath, it further reported "after she received her Pfizer COVID 19 vaccine, her immune/autoimmune disorder improved or cleared up, her allergies cleared up and she wanted to report that. She confirmed her allergies and her immune system calmed down following receiving the vaccine". The patient previously took Flu shot in 1993 and experienced 107.5 fever, worse flu, immune system totally crashed, the patient also previously took hep B vaccine. She was immunocompromised and she had no response with the first dose but she was very surprised on the response she had from the second dose. She has lupus as her autoimmune disorder and she can't take any lupus medications because her liver rejects them. The COVID vaccines flared her lupus a bit. On top of the normal side effects she also had a flare of lupus and her genetic Epstein Barrs but she was so happy to get the COVID vaccine that she didn't care because if she developed side effects that were bad then she told her doctor that she would just go to the hospital. The patient stated everything she experienced was after the second dose but it was not near as bad as when she had a flu shot in 1993. At this time, she worked with the county and got out of research and went for a title of clinical crisis forensic addiction expert in a jail for mental illnesses and substance abusers. She was trained in academies and she went into the clinic and got out of research. In 1993 her job made her have the hep B vaccine and on the third month of the hep B vaccine the county nurse kept arguing about the caller receiving the flu shot and she told the nurse that she will get the flu because she has a poor immune system and the nurse said no she wouldn't and the caller got sick of being bothered so she got it and that night she had a 107.5 fever and had the worse flu that she has ever had for 2 weeks and her immune system totally crashed and she has never had a healthy day after that and she reported this already to VAERS a while back. She didn't have a concern with the Pfizer COVID vaccine because it is an mRNA vaccine and she wasn't concerned with having another fever like she had with the flu shot, she was told not to get a flu shot ever again. Currently she was disabled and retired. The second shot she had a reaction to the side effects. Her lupus flared and she has genetic Epstein-barre virus and she had a flare up of that as well. She had typical side effects from COVID second vaccination as well. She did not have the positive reaction on the second one, she clarifies she did not have the calming down and the improving of her allergies and autoimmune issues with the second dose. She got the second dose on 22Apr2021. She had the typical 103 fever, she got the second dose at 9 am in the morning and at 10 that night she started having 101 fever and it was 103 the next day, the fever lingered 72 hours. She had increased fatigue and soreness in arm, she can partially say that is due to how the nurse gave the injection. This woman gave it to her like her arm was a piece of wood and she pinched her arm up before she gave it. The fever improved after 72 hours yet with her normal immune problems, with her lupus and the Epstein-barre flare up she will have mini low grade fevers that go up and down and that lasted for about a little over a week. She noticed swelling of her lymph glands around the 3rd and 4th day and that lingered and is also an indication of an Epstein-barre virus flare up. Fatigue: Started 22Apr2021 by that night and was alleviated about day 8. Soreness in the arm: Started the same day 22Apr2021 and lasted about 4 days. She had recovered it lingered about 8 days but as of currently it had recovered completely. Her Epstein-barre virus flare up signs were lymph gland swelling, ear pain, and throat was sore. She noticed those 72 hours after. She was recovered currently, she increased her natural remedies, no further information provided. She did not know if this is vaccine related or not but 48 hours after the second dose she had liver pain, which is a typical thing with the Epstein-barre virus, she confirmed she noticed that 48 hours taking the dose and she started taking a sublingual liver detox to clear that up. Then she had at 48 hours -72 hours after the vaccine, on the right side of the heart, sharp pain after the vaccine that is indicative of lupus. She confirmed that all of these were things she experienced at time prior to receive the vaccination but she did not have a flare when she got the vaccine, she had typical side effects then boom she got into a lupus flare and an Epstein-barre virus flare which was genetic disorder so is lupus, they are sisters. She was a part of a lupus study based out of state. She was surprised by the positive effect after the first shot and wished it would have lasted longer. She wanted to tell her research friends that she wants a nano particle COVID vaccination to knock all of that stuff out. The outcome of event "soreness in arm" was recovered in 2021. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.
55 2021-06-02 tingling, numbness After first shot (4/19/21), roughly 6 hours later, I got a numb patch on my head that wrapped from o... Read more
After first shot (4/19/21), roughly 6 hours later, I got a numb patch on my head that wrapped from one temple over the top of my head to other temple. It wend away after approximately 48 hours. After second shot (Monday 5/10/21), roughly 6 hours later, my entire face had a numbing and tingling sensation. By Weds 5/12, mid afternoon, it went away on the right side of my face only. Left side of face, Nose and mouth still had the sensation. Thurs and Friday the sensation was getting weaker. On Saturday 5/15, the sensation became stronger, still on the left side of face, nose and mouth, but now also moved down the back of my neck, my entire left shoulder, arm and hand. Also, by saturday afternoon, I had a series of blisters on the inner edge of my upper lip. I do not get blisters in my mouth. The blisters were gone within 2 days. I have not lost feeling at all, just an annoying numbing/tingling sensation. I did see my family Dr, and she ruled out Bells Palsy, as there is no weakness, and did routine testing to verify it is not neurological. Her suggestion was to wait for 6 weeks, to see if it just goes away. It has now been 3.5 weeks and is no better, or no worse. I am not comfortable just sitting and waiting 6 weeks. My online research shows that during testing of this, other people had the same reaction. I would love to know how they treated it.
55 2021-06-02 tingling Onset of neck tightness, tingling, difficulty swallowing, reported angioedema of soft palate, nausea... Read more
Onset of neck tightness, tingling, difficulty swallowing, reported angioedema of soft palate, nausea. Sent to ER via wheelchair with ongoing sensation of choking and one episode of vomiting. Sensation of difficulty breathing. Administration of epipen upon arrival to ER. Following this, VSS and no further noted angioedema. Overall began to feel better. Additionally treated with solumedrol, benadryl and pepcid. No rash at any point. No labs drawn. Observed x 5 hours with no return of sx.
55 2021-06-03 weakness back felt like truck hit entire back; headache; rapid heartbeat; SOB; leg weakness; legs feeling hea... Read more
back felt like truck hit entire back; headache; rapid heartbeat; SOB; leg weakness; legs feeling heavy; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL9261 and Expire Date: 30Apr2021) in left arm via unspecified route of administration, on 08Feb2021 at 18:30, as single dose for covid-19 immunisation. The patient previously administered first dose on 18Jan2021 at 19:45 PM, (lot number: EL1284) in left arm. She did not administer any other vaccines in four weeks. Prior to and since vaccination, she was not diagnosed with Covid-19. Past drug and known allergies included Remicaid infusion, and had rapid heartbeat, sob, weakness. Medical history of patient included Crohns disease, Rheumatoid arthritis and Vit d deficiency. Other medications in two weeks were Tramadol, Cellcept (Mycophenolate), Gabapentin-ER, Vitamin D. The patient experienced rapid heartbeat, sob, leg weakness, legs feeling heavy on 08Feb2021 at 18:35, which lasted for 3 minutes. The next day on 09Feb2021, his back felt like truck hit entire back, still leg weakness, headache. The outcome of event was recovered for rapid heartbeat, sob, legs feeling heavy, leg weakness, headache, back pain. The patient did not receive any treatment for the events. The patient underwent lab tests which included heart rate with results as rapid on 08Feb2021. Information on the lot/batch number has been requested.
55 2021-06-03 cold sweat Continued joint soreness, low grade fever, fatigue, clammy, plaque psoriasis continuing to flare up ... Read more
Continued joint soreness, low grade fever, fatigue, clammy, plaque psoriasis continuing to flare up after a year of none!
55 2021-06-03 flushing Pt reported SOB on floor after receiving vaccine. Lungs CTA x 5 lobes. No stridor noted. Slight... Read more
Pt reported SOB on floor after receiving vaccine. Lungs CTA x 5 lobes. No stridor noted. Slight flushing in face upon arrival to med obs, resolved within approx 3-5 min. Pt drank 1 bottle water and guided through relaxation deep breathing exercises. Pt reports SOB resolved at 1614. Released w/ family after orthostatic VSS and pt reports SOB resolved and denies any other subjective symptoms. VS obtained over long sleeve shirt to accommodate for pt culture, religion, and/or modesty at pt request VS 1557 SITTING BP 140/95, HR 89, RR 20, 97%RA 1603 SITTING BP 136/96, HR 82, RR 18, 99%RA 1615 SITTING BP 143/97, HR 81, RR 16, 96%RA 1617 STANDING BP 145/95, HR 86, RR 16, 97%RA
55 2021-06-03 flushing Less than 30 minutes after injection (1st dose), patient-reported chest tightness, SOB, flushing; im... Read more
Less than 30 minutes after injection (1st dose), patient-reported chest tightness, SOB, flushing; immediately perioral tightness. PE flushing face and chest, perioral hives. Lungs clear. RRR Cannot r/o anaphylaxis Epi 0.3 mg administered LLE BP 193/103 Sat 98% RA Paramedics called; pt transported
55 2021-06-03 numbness, tingling, sensory loss Non-stop tingling in fingertips and tips of toes. Loss of feeling and sensitivity in fingernails, fi... Read more
Non-stop tingling in fingertips and tips of toes. Loss of feeling and sensitivity in fingernails, fingertips, toenails and tips of toes. Tingling and numbness bottom of feet. Not ticklish anymore, cannot feel tickling sensation. Arms and hands constant feeling of ?falling asleep?, circulation poor. Bouts of lightheadedness. Two instances of extreme sweating and fever like symptoms several weeks after shot.
55 2021-06-03 muscle twitching, numbness hurt all over; numbness in shot arm; headache; nauseous; shortness of breath that was scary; pouring... Read more
hurt all over; numbness in shot arm; headache; nauseous; shortness of breath that was scary; pouring sweat/excessive sweating; itching; eye twitching; sick; really tired; This is a spontaneous report from a contactable consumer or non-health care professional (patient). A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine) (Lot/batch number: unknown) dose number 1 via unspecified route of administration on left arm as a single dose on 13Mar2021 at 12:00 (at the age of 55-year-old) for COVID-19 immunization. Patient was non-pregnant at the time of vaccination. Medical history included high blood pressure (BP) and fibromyalgia. No history of allergy to any medication or food or other products. Concomitant medications included the patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 14Mar2021, patient experienced scary shortness of breath, hurting all over, eye twitching, headache, excessive sweating/pouring sweat, numbness in shot arm, itching, really really tired, nauseous and was feeling sick for consecutive three days after vaccination. There was no treatment received for the adverse event. The clinical outcome of all the events was recovered with sequelae on an unspecified date in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
55 2021-06-03 pain in extremity Aches in neck, arms and legs; Aches in neck, arms and legs; Severe headache; Sneezing; Congestion; T... Read more
Aches in neck, arms and legs; Aches in neck, arms and legs; Severe headache; Sneezing; Congestion; This is a spontaneous report from a non-contactable consumer (patient herself). A 55-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 at 19:00 (at the age of 55-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history included obesity from an unknown date and unknown if ongoing. Concomitant medication(s) included magnesium citrate (MAGNESIUM CITRATE), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and multivitamin. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was not reported whether the patient have allergies or not. On 03Mar2021 at 20:00, the patient experienced aches in neck, arms and legs, severe headache, sneezing and congestion. No treatment was given for the events. The outcome of the events was resolved on an unspecified date in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
55 2021-06-03 pain in extremity Sore arm; chills; body fatigue; This is a spontaneous report from a contactable consumer (patient). ... Read more
Sore arm; chills; body fatigue; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: En6203), via an unspecified route of administration, administered in right arm on 05Mar2021 03:00 PM (age at vaccination was 55 years) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was no known allergies. No other vaccine was received by patient in four weeks and no other medications was received by patient in two weeks. The patient was not had covid prior vaccination and not tested for covid post vaccination. On 05Mar2021 10:00 PM, the patient experienced sore arm, chills and body fatigue. No treatment received for adverse events. Outcome of the events was recovered on an unknown date. No follow-up attempts are possible. No further information is expected.
55 2021-06-03 pain in extremity Sore arm; Headache; This is a spontaneous report from a contactable consumer, the patient. A 55-year... Read more
Sore arm; Headache; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Lot Number: EL3247) via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 Immunisation. Medical history included hypertension. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included BENICAR, SINGULAIR and multivitamins/multiminerals, these medications were used within two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, batch/lot number: EL3247) via an unspecified route of administration in the left arm on 22Feb2021 at 13:15 as a single dose for COVID-19 Immunisation. The patient experienced sore arm and headache on 17Mar2021 at 18:00. Therapeutic measures were taken as a result of sore arm and headache and included treatment with TYLENOL for headache and used ice on arm. The clinical outcome of the headache and arm in pain was recovering. No follow-up attempts are needed. No further information is expected.
55 2021-06-04 pain in extremity Sore arm; Extreme fatigue; Headache; chills; fever; bodyaches; This is a spontaneous report from a n... Read more
Sore arm; Extreme fatigue; Headache; chills; fever; bodyaches; This is a spontaneous report from a non-contactable consumer (patient). This case is for first dose. A 55-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: EM9810) via an unspecified route of administration in the left arm on 08Feb2021 at 10:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient also received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: EN6205) via an unspecified route on 01Mar2021 at 10:15 in left arm for COVID-19 immunisation. In addition to sore arm lasting weeks, patient experienced extreme fatigue, headache, chills, fever, and body aches, all on an unspecified date in 2021. Sixteen hours after second dose, woke up to heart stuck in overdrive. Heart condition repeated an hour later while still awake. No treatment was received for the adverse events. The outcome of all the events were resolved at the time of report in 2021. No follow up attempts are needed and no further information is expected.
55 2021-06-06 burning sensation leg burning, nausea, doesnt feel well
55 2021-06-06 muscle spasms Next day I got rash, redness, and swollen lyph nodes on left arm, hot to touch and itchy on injecti... Read more
Next day I got rash, redness, and swollen lyph nodes on left arm, hot to touch and itchy on injection site. I also had aches and pains which little by little started to get worse and turned into spasms in my right side of my back, shoulder blade and elbows swollen and hurting. The my right started to hurt and continued elbow pain. To find out there is now inflamation in my blodd.
55 2021-06-06 pain in extremity Initial fever with neck, back and right thumb pain. Eventual diagnosis of sepsis. Four day hospital... Read more
Initial fever with neck, back and right thumb pain. Eventual diagnosis of sepsis. Four day hospital stay. Discharged home on Keflex antibiotic and meds for back pain. Four weeks later diagnosed with low EF of heart. Receiving meds to improve EF.
55 2021-06-07 weakness diarrhea (11 times); Throw up 3 times; Chills; Weak; This is a spontaneous report from a contactable... Read more
diarrhea (11 times); Throw up 3 times; Chills; Weak; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 07Mar2021 at 11:32 (Batch/Lot Number: EN6205) as 1st dose, single dose for covid-19 immunization. Medical history included asthma and Chronic Obstructive Pulmonary Disease (COPD). Allergies to medications, food, or other products included all cillins, sulfer drugs and Lomotil. Concomitant medications received within 2 weeks of vaccination included acetylsalicylic acid (ASPIRINE), montelukast (MONTELUKAST) and pravastatin (PRAVASTATIN).Prior to vaccination, patient was not the diagnosed with COVID-19. Patient received no other vaccines within 4 weeks prior to the COVID vaccine.The Patient got the first vaccine on Sunday, 07Mar2021 at 11:32 hours, patient sat around for 15 minutes and left.On 07Mar2021, at 17:15PM, patient had severe episodes of throwing up (three times), diarrhea (11 times), had chills and was weak. Patient stated she drank sports drink but spent 8 hours in the bathroom and slept in the bathroom for hours.It was reported that patient waited on phone for 2 hours and none picked up and stated she should never had taken the vaccine. Patient called again and still waiting and stated will be going to ER if this does not stop.It was reported on page 2, that do not get the 2nd vaccine if you had a severe reaction. Her second dose was scheduled on Sunday the 28Mar2021 and she does not know what to do. she had COPD but her breathing issues were not affected. All the doctors suggest she get the second dose except one doctor.The patient had heard of people who have had reactions, just not as bad as hers, and they got the second vaccine. Some people say she won't have a severe reaction after the second if she had this type of reaction from the first and some say some say it could be worse. She asked what she should do about her second dose. After verbal response she reported that she was still going to go on the 28th for her second dose and will let them know about her symptoms but wondered if it was up to their discretion if she gets the vaccine or not. She stated her healthcare professional offered her a Zofran prescription before the next dose but she said she was not nauseous. Patient asked if there was anything she could take for these symptoms before her next dose and stated she had reported this. Since the vaccination, patient had been tested for COVID-19 by rapid COVID test, result: unknown. Patient received no treatment. The outcome of all the events was not resolved. No follow-up attempts are needed. No further information is expected.
55 2021-06-07 weakness Big pimples on right side cheeks/Pimples on end of tongue; Lump in right side of throat; Chills; Wea... Read more
Big pimples on right side cheeks/Pimples on end of tongue; Lump in right side of throat; Chills; Weak; Dizziness; This is a spontaneous report received from a contactable consumer (Patient). A 55-year-old female patient received second dose of BNT162B2(PFIZER BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 18May2021 (at the age of 55 years) (Batch/Lot Number: EW0176) as second dose, single dose for covid-19 immunisation. Medical history included ongoing asthma Diagnosed about 2 years ago. The patient's concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Lot Number: EW0162) received on 23Apr2021 (at the age of 55 years). Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient denied any family medical History Relevant to adverse event. On an unspecified date in May2021, the patient experienced big pimples on right side cheeks/pimples on end of tongue, lump in right side of throat, chills, weak and dizziness. She stated that she had the Covid Pfizer Vaccine, second dose, on 18May2021. She then travelled on 24May2021. She was having side effects and wanted to report them. She was currently out of the country. Stated that the symptoms started after the second dose of the vaccine; but before she travelled out of the country. She developed big pimples on the right side of her cheeks. then a lump in the right side of her throat. She thought these were going away, so she went ahead and travelled. She stated now they've gotten bigger. She also had pimples on the end of her tongue. States she also experienced chills, being weak, and dizziness but that was okay now. Now everyday she noticed something new. She would like to know if she should continue this way if symptoms persist. Should she go back and receive treatment, or she should wait. She called her healthcare provider, but she isn't working on Fridays. She denied any medications, labs, testing, or treatments relevant to events. She was not visited to either emergency room or physician's office. Relevant teste was reported as none. The outcome of event Big pimples on right side cheeks/Pimples on end of tongue was unknown, Lump in right side of throat was worsened and not recovered and chills, weakness and dizziness were recovered on an unspecified date in May2021.
55 2021-06-07 feeling hot Swollen arm/arm had swollen up; Swollen arm, It was also warm and hot/it is warm, has heat to it; it... Read more
Swollen arm/arm had swollen up; Swollen arm, It was also warm and hot/it is warm, has heat to it; it is hot and warm; It was long, swelling is like the shape of a football/swelling is from the shoulder and started to go downward; This is a spontaneous report from a contactable consumer (Patient's husband). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN0186), via unspecified route of administration in the Left arm, on 18May2021 at 12:00 PM (at the age of 55-year-old), as a single for COVID-19 immunisation. Medical history and concomitant medications were not reported. There was no family medical history relevant to AE. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not received any additional Vaccines administered on same date of the Pfizer Suspect. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27May2021, Yesterday around the afternoon her arm had swollen up, it is warm a little, has heat to it and it was long (clarified it was long as for the swelling is in shape of like a football). The swelling was from the shoulder and started to go downward. They tried to put an ice pack on it because it was hot and warm. They were wanting to know if there was anything to worry about and what are the side effects if she would experience and whether she need to pay attention especially, since it was been 9 days of vaccination. And whether the patient wanted to go hospital or it would be fine. The reporter also stated that he also wanted to take the shot but had worries on how safe it is for him to take it for himself. The adverse event does not resulted in Emergency Room or Physician Office. There was none relevant tests. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
55 2021-06-07 numbness, muscle spasms, tingling This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6203, expiration date not provided), 2nd dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 at age of 55 years old as a single dose for COVID-19 immunisation; mepivacaine hcl (manufacture unknown), via an unspecified route, date, dose for an unspecified indication. Medical history included Shingles. Concomitant medication included enalapril maleate (VASOTEC) taken for blood pressure. The patient previously took morphine and experienced allergies, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9265, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 11Feb2021 as a single dose for COVID-19 immunisation. The patient experienced guillane-barre syndrome, tingling and numbness in the legs, arms and lower face, severe headache, imbalance, disorientation, muscle spasms, diarrhea, all on 16May2021. The action taken in response to the events for mepivacaine hcl was unknown. The outcome of the events was not recovered. No treatment received for the events. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Pfizer is a marketing authorization holder of [mepivacaine hcl] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [mepivacaine hcl] has submitted the same report to the regulatory authorities.
55 2021-06-07 migraine VAERS ID from previous report 1036950 Headache and confusion that started 20 hours after 1st dose of... Read more
VAERS ID from previous report 1036950 Headache and confusion that started 20 hours after 1st dose of the Pfizer vaccine. Hearing sensitivity by day 3. In ER for high blood pressure on day 8 with no explanation. Nursing Staff at my place of employment informed me I needed to be in the ER that day due to BP of 187/120. I had an MRI of my brain showing migraine-like activity. It is almost 4 months from the date I received the vaccine and I have had only 9 days with no migraine. I'm tired of all the headaches that are completely new since the vaccine. Thankfully my doctor instructed me not to get another dose. I'm tired of feeling like this and feel I have no one to turn to for help. The migraines are affecting my daily activities and my work.
55 2021-06-07 pain in extremity Temperature 103, body aches, blinding headache, arm extremely sore, deep cough. Total of 36 hours b... Read more
Temperature 103, body aches, blinding headache, arm extremely sore, deep cough. Total of 36 hours but now just dizziness and feeling exhausted. Really thought about going to hospital and I have never been that sick in my life.
55 2021-06-08 bell's palsy Bells Palsy with no apparent reason.
55 2021-06-08 breast pain started her period, it was lite; started to ovulate; breasts were sore and tender; breasts were sore... Read more
started her period, it was lite; started to ovulate; breasts were sore and tender; breasts were sore and tender; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: EL9261) as 2nd dose, single for Covid-19 immunization. The patient received the first dose of BNT162B2 on 21Jan2021 (at the age of 55years) for Covid-19 immunization. Medical history included menopause from Jul2019, and fibromyalgia from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included duloxetine (DULOXETINE); cyanocobalamin (B12); ergocalciferol (VIT D); sambucus nigra (ELDERBERRY); zinc (ZINC), and Vitamins (unspecified); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she has not had a period since Jul2019. She received her second Pfizer Covid shot on 12Feb2021. Then 7 weeks later, she started to ovulate, 1 week later her breasts were sore and tender, and then a week later she started her period, it was lite. It was just like her normal cycle used to be. The patient asked, "Are the vaccines causing menopausal women to start their cycle again after receiving their Covid vaccines?" There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovered on an unspecified date.
55 2021-06-08 nerve pain rash started to spread on the right leg/ rash still spread to the whole body/full body rash; allergi... Read more
rash started to spread on the right leg/ rash still spread to the whole body/full body rash; allergic reaction to something; hives; Itching; random nerve pains; enlarged lymph nodes on both sides of the neck (Left lymph node is larger).; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 07Apr2021 at 14:30 (at the age of 55 years old; Lot Number: EW0151, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history included ongoing reflux. Concomitant medication included pantoprazole for reflux since Dec2019. The patient also received her first dose of BNT162B2 on 17Mar2021 at 14:30 in left arm (at the age of 55 years old; lot number: EP6955) for COVID-19 immunization and experienced small rash on the lower left leg/little red rash on her left lower shin and the rash developed into some really bad itching. The patient received her second dose on 07Apr2021 and after some time, the rash started to spread on the right leg. She went to an urgent care and was told that she was having an allergic reaction to something. The rash still spread to the whole body. The doctor asked her if she had been hiking and she said she hasn't hiked in 20 years. She had no changes to the food she's eating, no laundry changes. The urgent care doctor prescribed prednisone and an antibiotic. The rash didn't get better. The rash turned into a full body rash and hives. She does not know the name of the antibiotic. Both bottles or containers of the prednisone and antibiotic have been thrown away. After she finished the prednisone and antibiotic, she went to her primary care doctor and the doctor agreed the rash looked like an allergic reaction. The patient also experienced itching. She was sent to a dermatologist and was prescribed second antibiotic and a steroid topical oil which somehow helped relieve the rash. The rash is clearing up now, she's finally not itching. This has been going on for two months. She also stated random nerve pains and enlarged lymph nodes on both sides of the neck (left lymph node is larger). The dermatologist did take a skin specimen or skin biopsy from her lower left leg and her right arm about 2-3 inches above her wrist on 18May2021 with unknown results. Those areas were deeper than a skin scraping, those areas had to be sutured. She does not have any results from the skin biopsy. She's guessing on the timing of when the rash first appeared on her left leg, she would guess about a week after receiving the first COVID-19 vaccine. At that time, it was only on her left leg. She still thought it was just a mosquito or spider bite, she didn't think it was related to the COVID-19 vaccine. The rash on her left leg was still present when she received her second COVID-19 vaccine. About 24 or 36 hours after she saw the dermatologist, she had improvement in her rash. The patient was also prescribed doxycycline 100mg capsules, take one capsule twice a day for 30 days. The steroid oil is fluocinolone acetonide topical oil 0.01%. Prior to her seeing the dermatologist the rash was spreading into a new area every day, it was almost full body, the rash was everywhere, every day there was more rash. Both doctors that she saw told her that the medication had nothing to do with her rash. She saw her primary care on 12May2021. She saw the dermatologist on 18May2021. Her primary care doctor wanted her to follow up with some blood work after seeing the dermatologist. She has not followed up with her primary care doctor yet. No vaccines administered on same date with the Pfizer vaccine. No prior vaccinations (within 4 weeks). The events resulted in physician office visit. The patient was recovering from rash and allergic reaction; recovered from itching on unspecified date; while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
55 2021-06-09 weakness A fast heartbeat; Dizziness; Weakness; This is a spontaneous report from Medical information team. A... Read more
A fast heartbeat; Dizziness; Weakness; This is a spontaneous report from Medical information team. A contactable consumer (patient) reported that a 55-year-old (same age at vaccination) female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EW0191) intramuscularly on 22May2021 as single dose in arm left for COVID-19 immunization/ preventative. Medical history reported was ongoing knee disability, she does not take any prescription medication for this, once in a while takes ibuprofen for pain. Diagnosed when she was 2 years old, ongoing thyroid developed as an adult (her mother had a thyroid condition), at least 20 years ago or so, ongoing allergies, breathing difficulties and sarcoidosis in her lungs. Concomitant medications reported was levothyroxine sodium (SYNTHROID, Tablet) orally and ongoing at 25mcg daily for thyroid and fexofenadine hydrochloride (ALLEGRA) for allergies in the morning. She will sneeze a lot if she does not take it. There were none additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks were reported. She explained since then, she has been experiencing a fast heartbeat, dizziness, and weakness. She asked if her symptoms, should continue for that long, now that it has been 13 days. Patient asked if she should get the second dose of the Pfizer-BioNTech COVID-19 vaccine if the side effects from the first dose persist. Around the day after the first dose, she thinks all the symptoms started, clarified all symptoms started Sunday 23May2021. It is not as much, but still enough that she can tell. For the first few days, almost first week even at night she was having it, at night she will still have the fast heartbeat. And now she was able to sleep through the night and when she wakes up the fast heartbeat will happen, it was not continuous but frequent enough during the day. She confirmed all the symptoms have slightly improved. Patient declined any treatment, she kept thinking it will go away. She takes two medications other supplements like vitamin b. In 2009 she was diagnosed with sarcoidosis in her lungs but was not given active treatment. They did tests and told her it was almost in remission and she would go in for check-ups. Two years ago, they told her she did not need any more check-ups, it is not active. The first year when she had breathing difficulties, she was given a medication and she was to take one puff of it and that was it. Stated it was not an inhaler or spray. It was a minimal dose that had a steroid in it, and she was concerned about the steroid. It was oral and she only used it as a precaution and to help with breathing. Her breathing issue went away as soon as she lost weight, so not sure if breathing issue was sarcoidosis or being overweight. The reporter assessed seriousness as non-serious. Outcome of the events was recovering. No follow-up attempts possible. No further information expected.
55 2021-06-09 tremor, weakness, tingling Had tolerable off and on body aches, fatigue and tachycardia for months before the vaccine. I coul... Read more
Had tolerable off and on body aches, fatigue and tachycardia for months before the vaccine. I could go a month or more without symptoms. vaccine 3/15 Fatigue, body aches and tachycardia got much worse and intolerable after vaccine 3/15 8 days later at physical doctor gave me thorough exam and I become much sicker which escalated (I couldn?t do anything including work) Got to the point I was in constant horrible pain Severe body aches and fatigue Increased HR especially when upright Very dizzy SOB Some Headaches Nauseas almost always when I am upright Terrible Brain fog Body ache Symptoms improved some with prednisone but have gotten worse again since being off prednisone Struggling to function / work Left / middle Chest pain Tingling lips, finger tips and toes Weak Shaky
55 2021-06-10 breast pain This is a spontaneous report from a contactable consumer, the patient. A 55-year-old [non-pregnant] ... Read more
This is a spontaneous report from a contactable consumer, the patient. A 55-year-old [non-pregnant] adult female received a dose (unspecified dose number) of BNT162B2 (solution for injection; Lot unknown and expiry not provided) as a single dose via unspecified route in the left arm on 27Apr2021 at 12:30 (at 55-years-old), for COVID-19 immunization. Relevant medical history included penicillin allergy. Concomitant medications sans indication, posology and therapy dates included fluoxetine hydrochloride (PROZAC), and bupropion hydrochloride (WELLBUTRIN SR). The patient denied any COVID diagnosis prior to vaccination. The patient was not pregnant at the time of vaccination and denied receiving any other vaccine within four weeks of this vaccine. On 14May2021 the patient began to experience smelling cigarette smoke when none was there. The patient stated that sometimes it makes her choke a little. The patient also began to experience extremely painful and swollen breasts since 14May2021. The patient has not been tested for COVID since the vaccine. The outcome of the events smelling cigarette smoke when none was there, makes her choke a little, and extremely painful, swollen breasts was not recovered. Information on the Batch/Lot number has been requested.
55 2021-06-10 facial paralysis, mild one side paralysis, weakness, inability to speak 55 y.o. female with a lifetime history of insulin-dependent diabetes that presented to the emergency... Read more
55 y.o. female with a lifetime history of insulin-dependent diabetes that presented to the emergency room just a few hours after she started having a left-sided neurologic deficit. The patient reports that she had a stroke several years ago but for some reason was told to not take aspirin and was not started on Plavix. Irregardless, the patient came in with a very significant left-sided neurologic deficit. She states that she could not speak, she had left facial droop, left arm weakness, and left leg weakness. She initially had an NIH stroke scale in the emergency room of 11. Initial CT of the head showed nothing acute. Consultation with neurology was obtained and the patient was sent for a CTA of the head and neck. No large vessel occlusion was identified and shortly after this the patient's NIH stroke scale reduced to 2 and shortly after this the neurologic deficit completely resolved and stroke scale return to 0. At that point, the patient was diagnosed with a TIA and admitted to the hospital for observation. This morning she states she feels fine. She has no neurologic deficit whatsoever. She denies any sensory or strength deficits this morning at all. The patient sugars have been a little bit high, but otherwise she had an uneventful evening
55 2021-06-10 nerve pain 01/29/2021 I had scorpion feeling bites (pain) left upper shoulder and bite, had 3 to 5 lesions that... Read more
01/29/2021 I had scorpion feeling bites (pain) left upper shoulder and bite, had 3 to 5 lesions that were diagnosed as shingles. occasionally still have some residual nerve pain from the shingles.
55 2021-06-10 pain in extremity, weakness I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pai... Read more
I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; I have side effects:Injections pain, swelling, redness, itching.; Tiredness; Headache; Nausea; Feeling unwell; Arm pain; Weakness; Short of breath; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178), via an unspecified route of administration, administered in Left arm on 03Jun2021 at 17:00 (at the age of 55-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. and the patient had no known allergies. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, probiotic supplement (PROBIOTICS NOS) taken for an unspecified indication, on an unspecified date received in two weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0185, Expiration date: unknown), via an unspecified route of administration, administered in Left arm on 13May2021 17:00 at the age of 55-years-old for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 04Jun2021 at 11:00, the patient experienced side effect Injections pain, swelling, redness, itching, Tiredness, Headache, Nausea, feeling unwell, Arm pain, Weakness and Short of breath. patient did not received any treatment for adverse events. The outcome of the events was unknown. .
55 2021-06-10 pain in extremity On 02/25/2021 I experienced a fever, headache, arm and back pain, nausea, brain fog, COVID tongue, d... Read more
On 02/25/2021 I experienced a fever, headache, arm and back pain, nausea, brain fog, COVID tongue, dizziness. On 02/26/2021 I was very tired, high heart rate and shortness of breathe. On 02/27/2021 I was tired with a headache but better. On 02/28/2021 Less tired and headache was better. On 03/01/2021 I was less tired and back to 80%. On 03/10/2021 I went to the doctor because it was difficult to walk due to high heart rate and shortness of breathe with chest pain.
55 2021-06-10 pain in extremity Diverticulitis; Sore arm; Fatigued/ very tired; sluggish; pain with getting up and walking; This is ... Read more
Diverticulitis; Sore arm; Fatigued/ very tired; sluggish; pain with getting up and walking; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8731), via an unspecified route of administration on 24Apr2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8727) on 01Apr2021 (at the age of 55-years-old) for COVID-19 immunisation. On 24Apr2021, the patient experienced sore arm that lasted for about 3 days; felt fatigued and sluggish for the first couple of days post vaccination which started to taper off by 27Apr2021. It was in and out now. On an unspecified date in 2021, after the second vaccination, the patient was fatigued and very tired, had pain with getting up and walking. On 08May2021, the patient ended up in the hospital and was diagnosed with diverticulitis from eating a lot of nuts (as of an unspecified date in 2021). She was hospitalized from 08May2021 to 10May2021. The clinical outcome of sore arm was resolved on Apr2021 (reported as 27Apr2021 or 28Apr2021), of diverticulitis and pain with getting up and walking was unknown, of "Fatigued/ very tired" and sluggish was not resolved.
55 2021-06-10 tingling, tremor Within 30-40 min of vaccination on the way home (around 7 pm) , friend developed sudden headache; fe... Read more
Within 30-40 min of vaccination on the way home (around 7 pm) , friend developed sudden headache; felt tingling around the nose and face; felt dizzy; had dry mouth; She was trembling; had rash around the collar for about 45 min to 1 hour; swollen right arm (injection site but no redness, vaccination arm); floating sensation; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old non-pregnant female patient received bnt162b2 (Lot Number: EN6202), via an unspecified route of administration on 12Mar2021 at 18:15 (at the age of 55 years old) as single dose for covid-19 immunization. Medical history included breast cancer left, cholecystectomy for stones, deep vein thrombosis (DVT) during pregnancy, oophorectomy. The patient's known allergies included chocolate-since 1997 received epinephrine and additional food allergy: banana, orange, almonds, fresh tomato, avocado and strawberries (burning of moth and tingling around the nose). The patient's concomitant medications were not reported. It was unknown that patient had other vaccine in four weeks. Within 30-40 min of vaccination on the way home (around 7 pm), friend developed sudden headache, felt tingling around the nose and face, felt dizzy and had dry mouth. Her husband was driving the car. They drove to (Name withheld) Emergency Room/Urgent Care in (Name withheld) where she was admitted for care and observation. Additional details: She was trembling and was brought in on the wheelchair, had rash around the collar for about 45 min to 1 hour. She was dizzy, felt like "floating". Eventually improved overtime. She stated that her vitals were stable, oxygenation was 98%. Per her report, she did not receive epinephrine. Diphenhydramine hydrochloride (BENADRYL) was suggested but she did not want to take it as she had "bad headache" post diphenhydramine hydrochloride. She remained in ER for about 5 hours and eventually was discharged home. She was improving on the 13Mar2021, but continued to have headache and dizziness/floating sensation throughout the day. Also reported swollen right arm (injection site but no redness, vaccination arm). All events occurred on 12Mar2021 at 06:15 PM. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. Treatment for events included paracetamol (TYLENOL). The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
55 2021-06-12 slurring, numbness Within the 15 minutes, I was just not feeling right short of breath / chest tight/ heaviness, and my... Read more
Within the 15 minutes, I was just not feeling right short of breath / chest tight/ heaviness, and my right arm feeling dead. The nurse brought me back to a room and then my head started swimming. Nurses checked my pulse and oxygen and they were fine. Within 5 -10 minutes everything got fuzzy The doctor came in and when she came in my, speeches started becoming slurred, my face numb, things just were just like I was another stroke. They gave me an aspirin and called an ambulance,
55 2021-06-14 weakness Day 1- 3 tired, slight pain at injection site, fever at injection site, pain & fever at some locatio... Read more
Day 1- 3 tired, slight pain at injection site, fever at injection site, pain & fever at some location as injection on right arm, some body ache on second as though slept in a too small bed or hunched in a chair, slight fever end of second day - lots of water 96 ozs or more, rest, food Day 4 still tired, legs and feet were stiff slight pain in back, fever a little worse, headache, slight sore throat, food went through we as soon as consumed - 2 Tyenol , 128 ozs or more of water Day 5 - 7 a little tired legs below knee a still stiff 2 Tylenols 128 oz of water Day 8 felt better Day 9 very sick in the morning around 9 am fever, weakness, nausea, headache, tired , food, Pedialyte, rested Tylenol Day 10 - 11 very tired slightly fever headache Pedialyte lots of water
55 2021-06-15 tingling, burning sensation burning sensation /I had burning in my hands; Hives; Stinging; they're a little swollen; tingling al... Read more
burning sensation /I had burning in my hands; Hives; Stinging; they're a little swollen; tingling all over; I broke out in a rash at my neck; This is a spontaneous report from a contactable consumer who reported for herself, a 55-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in left arm on 10Mar2021 at 12:30 (at the age of 55 years old) as first dose, single dose for COVID-19 immunization. Medical history included allergic to penicillin. Concomitant medication included ibuprofen (ADVIL). On 10Mar2021 at 16:30, the patient experienced hives, stinging, burning sensation within 4 hours of the injection. She further stated that 4 hours after administration of vaccine, she broke out in a rash at her neck and was tingling all over. She had burning in her hands and they're a little swollen. Urgent care put her on BENADRYL and prednisone twice and she doesn't know what to do because it's 'burny'. She was still feeling the tingling. The patient did not have COVID prior vaccination, and was not COVID tested post vaccination. The outcome of the events rash and swelling of hands was unknown, while the outcome of the remaining events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-06-16 weakness Her blood pressure can be normal for two solid days and then have a reading of 170/110. Her blood pr... Read more
Her blood pressure can be normal for two solid days and then have a reading of 170/110. Her blood pressure was about that high when she got to ER on 10Apr2021, in spite of Propanol.; Her heart started flipping around in her chest; a little localized pain to her right arm where the injection was given; whole body was aching; Caller was so ill she barely ate or slept for three solid days.; Caller was so ill she barely ate or slept for three solid days.; After the vaccine, her joints ached to move. To move her elbow was 10x worse than normal. To get up and walk on her knee, to use that joint, was 10x harder and hurt 10x worse than usual; left knee and left elbow were inflamed; Very dehydrated; aching something terrible, like all of her joints; pain in her neck; Herpes outbreak; Really dizzy and felt weak; Really dizzy and felt weak; her mouth was extremely dry, had a weird metallic/chemical kind of taste; her mouth was extremely dry, had a weird metallic/chemical kind of taste; horrendous burning on the left side, just on the lower part of her rib cage and encompassed the whole top of her stomach; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 15:00 (Batch/Lot Number: EW0150) as single dose for COVID-19 immunisation. Medical history included 2 time breast cancer survivor: The latest cancer (second time) was in February of last year, she lost a quarter of her breast again to six 1mm atypical lobular hyperplasia tumors all together in her right breast. Operated on a year ago. They did follow up scan in Sep2020. She was cleared for one year. Osteoarthritis: Patient had several places in her back, but the MRI's shown osteoarthritis was more prominent in her neck. On 18Sep2019, she was injured in whiplash type car accident. Neurosurgeon did complete MRI on all three sections (cervical, thoracic, and lumbar) two weeks after accident. He just redid a second neck MRI and the osteoarthritis is worse, lots of bone spurs. She does have osteosclerosis/arthritis, mainly in her spine, but she also has Carpal tunnel and a bad knee. Degenerative disc disease was diagnosed long ago. Spinal stenosis was diagnosed long ago. She had a previous surgery, 18 years ago, a fusion at C5 and C6 in her neck. She had injured both her left knee and elbow in past from falling down/tripping because of her vision. Sprained Elbow over extended backward, messed-up joint. Fell on left knee: No surgery but did mess up the joint but were inflamed. Borderline diabetic/pre-diabetic started in 2016, she was trying to control with diet. The patient had a little acid reflux, a little chronic pain. She contracted herpes when she was 27 (in 1991). Concomitant medication(s) included propranolol (PROPRANOLOL) taken for blood pressure measurement from Jan2020 to an unspecified stop date; fluorouracil (FLUOROURACIL) taken for skin cancer, start and stop date were not reported. Propranolol: can take one in morning if not too late, sometimes have to wait until 1100 or 1200 and then as needed if later in day or evening have sudden rise can take second one or half of a tablet. Started taking Propranolol after noticing a drop in Potassium and other minerals/electrolytes. She went into kind of an a-fib event with very low potassium, determined have sinus tachycardia secondary to something else. Sometimes, her blood pressure is 100/72, so she can't touch it. She kind of has to use it throughout the day as needed. Her blood pressure goes up and down because of her sinus tachycardia. Her normal blood pressure was considered low normal. Fluorouracil: She was not doing full body treatment (she has done full body before and those are wicked). She was only spot treating a couple places on her face, left arm and right top of shoulder (not where the vaccine was given). In current spot treatment. Battling basil cells and squamous cells since age 32. Been taking about 23 years now and currently in treatment for a couple that tested positive for basil cell. The patient previously received flu shot in sept of 2017, first ever had other than vaccines for school as a child and she got so sick with the Flu in Feb2018 for 10 days, she about died. She never took the flu shot again. Other than that, she has never had any other vaccines unless as a child. The patient had no Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE(s) was none. The patient received their first dose Pfizer Covid Vaccine on 31Mar2021 and was due to have second shot. The patient had immediate side effects, as well as had some after getting home for at least a week or better. She had immediate reaction and was made to stay in the store for 30 minutes to monitor. The facility has it set up where you go across to another area just across from the Pharmacy once you received the vaccine, and there was a lady there that puts a 15 minute timer on chairs and makes you sit down. The lady just stood there and monitored everyone, making sure no one was having any problems. As soon as the caller sat down, the caller said to her girlfriend who was sitting in front of her, "oh my God, I don't feel right." The lady monitoring everyone asks the patient if she was feeling okay. The patient responded no, and that she was feeling really dizzy and felt weak. The lady pulled over another chair and made the patient put her legs up and she went and got the pharmacist. The pharmacist and additional pharmacist who gave vaccination to the patient also came over. The pharmacist instructed someone to go get a "pulse ox finger reader thing", which was placed on the patient's finger. The pharmacist asked if patient felt anything else which the patient was. As soon as the her feet were put up and the lady went to get the pharmacist, she noticed her mouth was extremely dry, just like a dessert, and she had a really weird taste in her mouth. She clarified it was like a metallic kind of taste, or a chemical kind of taste. She has never tasted anything like that- she was not sure what to compare it to other than it just wasn't right. The pharmacist monitored the pulse ox after it was placed on her finger. Her oxygen level was good at 98 and her heart rate was good in the 80's. The timer was turned to 30 minutes instead of the original 15. All of this took place within the first 5 minutes after the patient sat down. The pharmacist instructed the lady to keep a close eye on patient and to keep the pulse ox on her finger. She kept her feet up the entire time. She couldn't have anything to drink after, the Pharmacist said no, and said if she had any further issues, to call 911. She made it through that 30 minutes. She held onto her girlfriend's arm going out of the store because she felt like her legs were kind of weak and rubbery. She didn't seem to be as dizzy, but the caller still had a real dry mouth and weird taste. States her girlfriend who drove was her neighbor and the patient doesn't drive. When the patient was dropped off at her place, a couple hours later, the patient was being cautious and on guard. Drinking water seemed to alleviate the dryness some in her mouth and kind of got rid of that taste. But then, she noticed horrendous burning on the left side, just on the lower part of her rib cage and encompassed the whole top of her stomach-literally was between belly button and bottom of breast, just that center area of her trunk, from rib cage to rib cage. She explained the burning started on her left side and moved across like fire toward her other rib cage. The burning lasted probably about 5-10 minutes. She tried not to panic and asked herself if she had eaten. She received the vaccine at 1500 and she had eaten lunch. She hadn't been sick or anything from lunch. She doesn't have any stomach issues that would cause intense burning. Caller has a little acid reflux, but wasn't burping or anything. This was just like instant, "on fire" pain that went from left to the right, right through the middle of her trunk area. Then, the burning went away about 5-10 minutes later. She ate dinner and carried on with evening. She noticed the next day, 01Apr2021, maybe late morning (10:00 or 11:00, before lunch), she had the same burning feeling again in the same spot. The left bottom part of her rib cage had real intense burning that went across her mid section from left to right, in between belly button and bottom of breast. Again, the burning lasted about the same, 10-15 minutes. It burnt so bad caller didn't eat lunch. She also noticed when getting up that next morning, 01Apr2021, she was aching something terrible, like all of her joints. She had a little localized pain to her right arm where the injection was given. However, she had no rashes or swelling. She was breathing okay- she was keeping an eye out on that, especially since having immediate reaction. The burning feeling in her stomach area, ribcage to rib cage, was off and on for about 3 or 4 days. She felt like she was dying because her whole body was aching. Her joints were hurting when she got up or down, sat up or got down, get up to walk. She does have osteosclerosis/arthritis, mainly in her spine, but she also has Carpal tunnel and a bad knee. She clarifies anywhere she had previous injuries kind of got inflamed to the max. It was hard to sleep. She clarifies her neck was inflamed. She had a previous surgery, a fusion at C5 and C6 in her neck. Her last MRI 2 years ago showed osteoarthritis. The pain in her neck began the following day, 01Apr2021 and is ongoing. She is going to get a nerve block because it is so bad. States the pain is persisting, definitely hasn't improved even with rest. She clarifies after the vaccine, everything was hurting 10x worse. Also, her left knee and left elbow were inflamed- she had injured both her left knee and elbow in past from falling down/tripping because of her vision. After the vaccine, her joints ached to move. To move her elbow was 10x worse than normal. To get up and walk on her knee, to use that joint, was 10x harder and hurt 10x worse than usual. She noticed the pain/aching the following day, 01Apr2021 upon getting up and down. If she leaned over to look at her phone with her head down, it was like "wow what's going on with my neck". She is used to having a little chronic pain, but not like that. If she could get by with two Tramadol a day, she isn't hurting that bad. She has never been on anything stronger than Tramadol 50mg or Tylenol #3 for her neck, even after surgery 18 years ago. She goes back in forth between Tramadol 50mg or Tylenol #3. If she could go that long without going to a pain clinic and or being on a higher dose/stronger, this was not a good ride. She took two Tylenol Extra Strength in the middle of the day and also taking her prescription, Tramadol one 50mg, twice a day (in the morning and at night), and she could not get this pain under control for 3-4 solid days. She doesn't normally hurt like that. She didn't want to take more Tramadol (she is only prescribed it twice daily) so she took two Tylenol mid-day to get through the pain. She was on Propranolol, has sinus tachycardia and she can't take Ibuprofen or any other the counter (OTC) anti-inflammatory drugs. She has to get it by prescription and she only gets when she needs it which isn't very often. Generally, the Tramadol keeps the pain enough where caller can function. Receiving the COVID-19 vaccine, must have caused major inflammatory issues that she usually doesn't deal with. She doesn't lift things- she is 55 and hurt. She doesn't get out and do jumping jacks. The vaccine laid her up. She felt like she was dying- that's how sick she for about 4 or 5 days. She couldn't sleep, couldn't eat, couldn't move, she couldn't function. Every time she moved, it hurt. If she rolled over in sleep or got up, it hurt meaning her neck, her elbow, left knee and wrist hurt. She states she has carpel tunnel and doesn't like to have surgeries unless she has to. She was just aching all over. She was too sick to eat and too sick to sleep. She was so ill she barely ate or slept for three solid days. She got very dehydrated. She had to go to the hospital to get rehydrated, that's how bad it was. She clarifies she went to the emergency room and they checked her blood work and all. They rehydrated her and sent patient home. The patient left a message for her doctor, and the doctor called her and advised the caller to get Gatorade zero- she has to watch her sugar because she is pre-diabetic. She started bouncing back. About the 5th day, she started to sleep once she got rehydrated and past the worst of the pain/inflammation in her joints. Then, she went into a herpes outbreak which she had not had in probably 5 years. She had to deal with this for another 10 days. The herpes outbreak began maybe about 3rd or 4th day after receiving the vaccine. She started feeling like she was going get a blister and did. She didn't take any antiviral drugs, she never has, she always just let her body fight it. The outbreak has been gone for a few days. The dry mouth and weird metallic/chemical taste tended to subside later that day on 31Mar2021, after she drank some coffee and lots of water as she was trying to wash it down. That symptom did subsided the following morning, 01Apr2021. She believes this has resolved completely. Every now and then, a couple days following, she may have had an odd taste but she kept eating and drinking and it finally went away. Just following this event, she had one of those swallowing tests where they went down her mouth with a tube, and she was having trouble swallowing at the same time. She states when she gets sick like this and is experiencing untreated pain, it's hard for her to sleep and eat, and that's how she got so dehydrated. Finally by 10Apr2021, she was so dehydrated her doctor sent her to the emergency room. Following feeling dizzy and weak right after the vaccination, she had a couple dizzy bouts. However, this could have just been her dehydration or her blood pressure coming and going/low blood pressure events. They say she has sinus tachycardia secondary to something else going on, but they don't know what it is. So, she can't always get up and take Propranolol. Sometimes, her blood pressure is 100/72, so she can't touch it. She kind of has to use it throughout the day as needed. Her blood pressure goes up and down because of her sinus tachycardia. Her normal blood pressure is considered low normal. She had a couple of little off balance/dizzy spells but she laid down and then it subsided. She took her blood pressure and it was low when these spells happened. Her blood pressure can be normal for two solid days and then have a reading of 170/110. Her blood pressure was about that high when she got to ER on 10Apr2021, in spite of Propanol. She went to the ER and she called her doctor and did a phone visit prior to going to emergency room. She went to the ER on 10Apr2021. The doctor did a phone visit with patient on 08Apr2021. That's when the doctor told her to go get Gatorade zero. The patient also sent neighbor after the carnation instant breakfast mix and milk to get something in stomach and tried to get herself rehydrated. By 10Apr2021, patient was too far gone, she had been really sick and was too dehydrated. Her heart started flipping around in her chest, and because she is prone to having low potassium (she couldn't check at home), she called into the office and the doctor told her to go into the ER in which she did on 10Apr2021. She explained her blood work came back okay while in the ER. She was given two bags of fluid and released her as being dehydrate and they rehydrated her. The patient stated that, just that it was really bad experience and obviously something about her body didn't like the vaccine, whatever it was. She would like to follow up but she was going to talk to doctor on 06May2021, did report to doctor about the burning in her stomach. She has never felt anything like that ever. It was really in left of her side, kind of tucked where patient's in lower rib cage area. The patient doesn't feel too comfortable about the second shot especially with inadequate pain. She was scared to death to go through this again (with the second dose). The patient was due to see the doctor and wanted to wait and reschedule second dose Pfizer Covid Vaccine, if the doctor thinks she should get the second dose after she speaks with doctor. Outcome of event had a weird metallic/chemical kind of taste was recovered in Apr2021; aching something terrible, like all of her joints, pain in her neck was not recovered and all other events was unknown. No follow-up attempts are needed. No further information is expected.
55 2021-06-16 feeling hot, pain in extremity and a pain and swelling on her left foot; and a pain and swelling on her left foot; She also felt wa... Read more
and a pain and swelling on her left foot; and a pain and swelling on her left foot; She also felt warm.; joint pain; swelling that radiated from her arch; the mark was still there on 18May2021 but the area is wider but lighter; exhibiting slight pain on scale of 1 to 4 time to time; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: FW0168) via an unspecified route of administration, administered in Arm Right on 18May2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Medical history included diabetic. There were no concomitant medications. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EW0172) on 26Apr2021 for covid-19 immunization and experienced dark marking over arch on side of foot. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. As after first dose she reported having a darkening and dark marking on her arch on the side of her left foot and after 2nd dose the mark was still there on 18May2021 but the area was wider but lighter and a pain and swelling on her left foot, with the pain level of 4 out of 10. She also felt warm. She also mentioned being diabetic and never having a problem on her feet before. Her HCP said that she would be undergoing tests. She also reiterated that joint pain was not same as foot pain and that her side effect should not be reported under joint pain. Reporter wanted to ask if these side effects have been reported yet. Reporter stated she got the second shot on 18May2021 and the mark was still there but maybe a week in a half after that she started exhibiting slight pain on scale of 1 to 4 time to time, swelling that radiated from her arch and it felt warm. Reporter also reported that, she went to see a podiatrist and she was prescribing a venous doppler to check it out. she wanted to notate this and how she had no issues with her feet previously. Patient stated felt warm started a week in a half after 18May2021. All events occurred in an unknown date in May2021. Patient visited to clinic. Patient stated she has taken Ibuprofen as treatment for felt warm, but she did not want to take it every day. The outcome of the events She also felt warm, swelling that radiated from her arch and exhibiting slight pain on scale of 1 to 4 time to time was not recovered and for other events was unknown Follow up needed, further information was requested.
55 2021-06-16 numbness, tingling Many open sores developed in mouth; numbness and tingling in most of myfingers; Some burning pain do... Read more
Many open sores developed in mouth; numbness and tingling in most of myfingers; Some burning pain down thearm that was injected also; tingling in most of myfingers; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm in Mar2021 at 14:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid, high blood pressure and chronic back pain. The patient had sulfa allergy years ago in his her 20s and had never tried it again. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oxycodone/acetaminophen (MANUFACTURER UNKNOWN), tizanidine (MANUFACTURER UNKNOWN) and fentanyl patch (MANUFACTURER UNKNOWN), all from unknown dates for unknown indication and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The vaccine was administered in a pharmacy or drug store. On 18Mar2021, the patient had many open sores developed in mouth, while taking a nap and she had no symptoms prior. She also had some numbness and tingling in most of her fingers. There was some burning pain down the arm that was injected also. The patient did not receive any treatment for the events sores mouth, numbness in fingers, pain burning and tingling. The clinical outcome of the events sores mouth, numbness in fingers, pain burning and tingling was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
55 2021-06-18 pain in extremity Hallucinations; Arm pain; Joint/lymph pain; joint/lymph pain; Splotchy red spots and itching; Splotc... Read more
Hallucinations; Arm pain; Joint/lymph pain; joint/lymph pain; Splotchy red spots and itching; Splotchy red spots and itching; Felt like my arms and legs were not connected, a disconnected feeling to reality, like the world was moving around me, trees were closing in; Extreme fatigue; Could not hardly move; Slept for 2 days straight; Loss of appetite; Digestive issues; Feel a little out of sorts; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female (not pregnant) received second dose of BNT162B2 (lot number - EW0182) on Arm left on 20May2021 (at age of 55-year-old) 10:30 AM at single dose for Covid-19 immunisation. Medical history included Hypersensitive to meds, peanuts bother her, Splenic Hemangiomas, Hypoglycemia. Concomitant medications included paracetamol (TYLENOL) and origanum minutiflorum oil (OREGANO OIL). Historical vaccine included first dose of BNT162B2 (lot number -EW0170) on Arm Right on 29Apr2021 (55-year-old) 01:15 PM for Covid-19 immunisation and experienced some brain fog, arm pain, horrible joint/lymph gland pain, feeling of small needles poking me in the head, a disconnect with her arms and legs and fatigue. This lasted about 4 days. Facility where the most recent COVID-19 vaccine was administered:Doctor's office/urgent care. No other vaccines within 4 weeks prior to the COVID vaccine. The second vaccine had arm pain, joint/lymph pain, splotchy red spots and itching, felt like her arms and legs were not connected, a disconnected feeling to reality, like the world was moving around me, trees were closing in, and hallucinations. That last for 5 days. Then there was extreme fatigue... could not hardly move and slept for 2 days straight. At this point, I had a loss of appetite and digestive issues. Events onset date was 20May2021. All in all it last almost 2 weeks. Still feel a little out of sorts but feeling better. The outcome of the events was recovering. No treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
55 2021-06-19 nerve pain, pain in extremity Less than 48 hours after receiving my first dose of Pfizer Covid-19 vaccine, I developed nerve pain ... Read more
Less than 48 hours after receiving my first dose of Pfizer Covid-19 vaccine, I developed nerve pain in my left leg. I experienced signifcant pain upon standing from a prone/supine or sitting position. I have seen an Urgernt care NP who said it was muscular and prescribed flexeril (did not help), then a physican who prescribed a steroid for siatica (did not help) and then I went to PT and have been doing the prescribed exerices. Over time, the condition has improved, but I still experience pain when sitting along oustside of left leg I recognize the timing of this injury could be completely coincidentital, but I am reporting it in the event that others have had a simiiar experience and a pattern can be identified.
55 2021-06-20 weakness, tremor Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Body Aches Genera... Read more
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
55 2021-06-20 weakness Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch Ge... Read more
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Weakness-Mild
55 2021-06-20 pain in extremity, tingling, numbness Patient presented to emergency department with complaint of left-sided arm pain/numbness that began... Read more
Patient presented to emergency department with complaint of left-sided arm pain/numbness that began 6/17/2021, approximately 11 PM. She reports sleeping on her right side and woke up with new onset of left arm pain. Patient also noted feeling as though she could not feel her pulse on left arm as much as her right. This is what prompted her to follow-up to the emergency department for further evaluation. Upon arrival she noted that left-sided arm tingling/pain had improved. Upon assessment patient states left-sided arm pain has returned and is now radiating towards mid chest region. Diagnosed with an occlusion in the distal brachial artery and proximal ulnar artery and she was started on heparin and went to surgery for a thrombectomy.
55 2021-06-20 tingling e I had a flare of my neurological symptoms of CIDP two weeks after my second vaccine. Dates of Vac... Read more
e I had a flare of my neurological symptoms of CIDP two weeks after my second vaccine. Dates of Vaccine, 4/5, 4/26. Unmistakable symptoms of tingling in hands and feet, difficulty walking, weakness in arms and hands preceded by knee weakness, about a week prior. Weakness in hands and arms such that I could not push up to lift body from mattress to get out of bed normally. Pain in hip, hands, neck, lumbar and mid-back, feet, wrist, arms. Bi-lateral S4 and S5 Steroid Facet Injection with trigger points including right hip on 5/17; led to improved walking hip/lumbar symptoms and some overall. The following two Hizentra infusions on 5/24 and 5/31 I believe also helped incrementally with overall symptoms. Some residual wrist and hand weakness remaining.
55 2021-06-21 bell's palsy, facial paralysis Noticed some kind of paralysis of my right side of my face including eye not being able to blink. A... Read more
Noticed some kind of paralysis of my right side of my face including eye not being able to blink. Approximately 3 hours after vaccine. My face dropped with difficult mobility. Went to see my eye doctor the next day thinking it had to do with my eye but was sent to the emergency room to rule out a stroke. Was diagnosed with Bells palsy after a stroke was ruled out. Cat scan was taken as well as bloodwork. Was sent home with Prednisone 20 mg. Instructed to take 60 mg a day for 6 days. Was also given Valacyclovir hcl 1 gram. 3 times a day for 7 days. Was also given eye drops from my doctor. Currently scheduled to see a doctor this coming Friday.
55 2021-06-22 numbness Numbness and weakness Left Leg; Numbness and weakness Left Leg; diagnosis Guillain Barre; This is a ... Read more
Numbness and weakness Left Leg; Numbness and weakness Left Leg; diagnosis Guillain Barre; This is a spontaneous report from a contactable consumer (patient). A non-pregnancy 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 24Mar2021 at 13:15 (at age of 55 years old, no pregnancy, Lot Number: EP6955) as a single dose for covid-19 immunization. No medical history and concomitant medications. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On 21May2021, the patient experienced numbness and weakness left leg. On 29May2021 Emergency room misdiagnosed Sciatica couldn't bear weight used wheelchair. Went to primary 02Jun2021, followed by Neurologist diagnosis Guillain Barre. Confirmed by spinal tap at hospital after ER visit and 5 day stay at hospital with immunoglobulin treatments. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Since the vaccination, the patient was not had been tested for COVID-19. The outcome of the events was not recovered.
55 2021-06-23 weakness Patient state that one week after the shot she stated having a mensuration discharge. Went to the Dr... Read more
Patient state that one week after the shot she stated having a mensuration discharge. Went to the Dr. pap smear was given on June 3rd and all test came back normal.. She is one year into mesopause. June 5th. Headache, fever over 100.2 and body was very week. Went too urgent care on June 7th. They took more test and samples. Negative for COVID. all test was normal except white blood cells were high. June 8th went to PCP more test were taken. Inflammation enzymes marker was high. June 10th fever went away. June 13th developed water stool. The stool and the discharge are still ongoing. June 18th went to urgent care more test. White blood cells were high again but still no cause of infection. June 24 went back to the Dr. ultrasound was performed. Came back normal. Patient believes that something from the shot has lounged into her Reproductive and intestine to cause these problems.
55 2021-06-23 pain in extremity I had severe hip pain and lower right back pain. I also experienced chills , fever, exhaustion , sho... Read more
I had severe hip pain and lower right back pain. I also experienced chills , fever, exhaustion , shortness of breath and pain in upper rt thigh with nausea.
55 2021-06-24 weakness Diarrhea; feeling weak; slept over half the week; This is a spontaneous report from a contactable co... Read more
Diarrhea; feeling weak; slept over half the week; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 28Jan2021 (at the age of 55-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease) diagnosed years ago. There were no concomitant medications. On 01Feb2021 the patient reported of feeling weak and on 02Feb2021 she had diarrhea. Reporter stated she had the first Pfizer shot on 28Jan2021, states all week she has felt weak and the last few days she has had the runs in the morning. Reporter stated that she had diarrhea in the morning only since Tuesday. Stated she started feeling weak on Monday, had slept over half the week on an unspecified date in Feb 2021, stated she never had to call out of work. At the time of report, outcome for events feeling weak and diarrhea were not resolved and slept over half the week was unknown. Follow-up attempts are completed. No further information is expected.
55 2021-06-24 migraine Client initially developed a migraine and fever the evening of vaccination. At 3:30 am the following... Read more
Client initially developed a migraine and fever the evening of vaccination. At 3:30 am the following day the patient began vomiting and had fainted and passed out in the shower. Client is currently, "experiencing light headedness and is fighting off a cold."
55 2021-06-24 migraine Migraine; vomiting; flu like symptoms; This is a spontaneous report from a contactable nurse, the pa... Read more
Migraine; vomiting; flu like symptoms; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number : EN6198, via an unspecified route of administration in the left arm on 25Feb2021 at 12:00 (at the age of 55-years old) as a single dose for COVID-19 immunisation. Medical history included connective joint arthritis, HTN, fibromyalgia. Concomitant medications include prednisone (MANUFACTURER UNKNOWN), hydrocodone (MANUFACTURER UNKNOWN), fentanyl patch (MANUFACTURER UNKNOWN), duloxetine (CYMBATLA), all for unknown indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 26Feb2021 at 00:00, the patient experienced migraine, vomiting and flu like symptoms. The clinical outcome of the migraine, vomiting and flu like symptom was recovered on unknown date in 2021. No follow-up attempts are possible needed. No further information is expected.
55 2021-06-27 pain in extremity Gi problems , loose stools up to 10 a day . stomach pain . hand and leg pain . fatigue
55 2021-06-28 pain in extremity 01/08/2021 About 2:30AM in the morning, I was awoken with leg pan and took ibuprofen, went back to b... Read more
01/08/2021 About 2:30AM in the morning, I was awoken with leg pan and took ibuprofen, went back to bed, next morning got up for shower, right leg was swollen and discolored. Husband took me to ER, and they did n ultrasound and then a CT scan and a covid test, they found multiple clots up and down my leg, also found an opaque infiltrate on upper left lung , multifocal PE with a larger PE on right side. I did have possible exposure to covid 19 on 12/21/2021 and my profession is an operating nurse.
55 2021-06-28 tingling, weakness, pain in extremity Entire left arm tingling, weak, pain in injection site area and forearm. Pain continues up left sid... Read more
Entire left arm tingling, weak, pain in injection site area and forearm. Pain continues up left side of neck and head, headache pain on left side of head and front left forehead. General fatigue.
55 2021-06-29 weakness, migraine Joint pain; extreme fatigue; Migraine; Dizziness when standing; overall weakness; Severe dehydration... Read more
Joint pain; extreme fatigue; Migraine; Dizziness when standing; overall weakness; Severe dehydration; his is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in the left arm on 17Mar2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, status post (s/p) lung cancer, obesity, double knee replacement due to car accident, disabled since 2004. The patient was allergic to penicillin. Concomitant medications included regular unspecified medications for pain, cholesterol and diabetes. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route in the left arm on 18Feb2021(at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced joint pain, extreme fatigue, migraine, dizziness when standing, overall weakness and severe dehydration on 17Mar2021 at 13:00. Therapeutic measures were taken as a result of joint pain, extreme fatigue, migraine, dizziness when standing, overall weakness, severe dehydration and included treatment with ALEVE, rest and hourly hydration. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events joint pain, extreme fatigue, migraine, dizziness when standing, overall weakness and severe dehydration was recovering at the time of report. Information about lot/batch number cannot be obtained. No further information is expected.
55 2021-06-29 burning sensation Just a small amount of facial burning; This is a spontaneous report received from a contactable othe... Read more
Just a small amount of facial burning; This is a spontaneous report received from a contactable other health care professional. This 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number& Expiry date not reported) via intramuscular route of administration in left deltoid on 11Jan2021 (at age of 55-years-old) as single dose for COVID-19 Immunization. Patient medical history include allergies sinuses, JRA (Juvenile rheumatoid arthritis at age of 16), GERD (Gastroesophageal reflux disease 2years ago),PSVT (Paroxysmal supraventricular tachycardia,15 years ago).Patients concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number:E49899 & Expiry date not reported) via intramuscular route of administration in left deltoid on 21Dec2020 at 13:40 as single dose for COVID-19 Immunization. On unspecified date , patient experienced just a small amount of facial burning, intermittent for 24 hours with second dose. No treatment received for event. The outcome of event was unknown. Follow-up (14May2021): Follow-up attempts completed. No further information expected.
55 2021-06-29 numbness, feeling hot, migraine About 15 seconds after the vaccine my arm and my hand started to go numb. Later that night i starte... Read more
About 15 seconds after the vaccine my arm and my hand started to go numb. Later that night i started to have a throbbing pain around the injection site. On the 22nd I still had pain in the injection area. I put hot and cold compresses on it. On the morning of the 23rd I woke up with a migraine headache and a low grade fever. I was also extremely hot. I also was very tender and sore in the arm. I took 2 Excedrin migraine medications. The hot sensation did not go away. It was so bad that even a fan did not help. My doctor stated that I had lymph nodes that were swollen and inflamed. The Excedrin took away the migraine but not the feeling of being hot. On the 21st, I also felt very lethargic after the vaccine. I stayed out of work on the 22nd. I was sent home on the 23rd from work due to the symptoms I was having. I also had swelling under my arm as well. This past Sunday was the first day that I was able to do my normal activities.
55 2021-06-29 migraine Fatigue; bad headache (migraine type); nausea; vomiting; mild soreness at injection site; This is a ... Read more
Fatigue; bad headache (migraine type); nausea; vomiting; mild soreness at injection site; This is a spontaneous report from a contactable health care professional, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: NDC number: NDC:59267-1000-01(as reported)), via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines and seasonal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not allergic to medication, food and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications within two weeks of vaccination included Vitamin D and C. The patient experienced fatigue, bad headache (migraine type), nausea, vomiting and mild soreness at injection site on 20Mar2021 at 05:00. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The patient did not receive treatment for reported events. The clinical outcome of fatigue, bad headache (migraine type), nausea, vomiting and mild soreness at injection site was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
55 2021-06-29 pain in extremity waves of nausea; diarrhea; pain and stiffness that slowly spread down left arm; sweating; Didn't fee... Read more
waves of nausea; diarrhea; pain and stiffness that slowly spread down left arm; sweating; Didn't feel well; pain and stiffness that slowly spread down left arm; headache; low-grade fever during night; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021 at 09:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal asthma, overweight, bronchitis, uterine fibroids and endometriosis. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), ADVIL, TUMS and RICOLA for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 10: 45, the patient did not feel well, pain and stiffness that slowly spread down left arm (below injection site), headache, low-grade fever during night then sweating. On the following day on 13Mar2021, the patient experienced waves of nausea and diarrhoea. The patient felt okay approximately (32 hrs after injection). The patient did not receive any treatment for the reported events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of did not feel well, pain and stiffness that slowly spread down left arm, headache, low-grade fever, sweating, waves of nausea and diarrhoea was resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
55 2021-06-29 pain in extremity 24 hrs. after receiving the 2nd dose, I had pain on moth wrists. Eight at the top where the wrist co... Read more
24 hrs. after receiving the 2nd dose, I had pain on moth wrists. Eight at the top where the wrist comes together. It was like I could put my finger on the pain points. When that went away after a day or two, I began getting stiffness in my hands and feet. It was mostly at night. I did have an episode where I went to get out of a chair and I felt discoordinated walking. The ankle and foot pain and stiffness has gone away. I still have an intermittent hand stiffness. It will sometimes wake me up at night and is usually there in the morning. It usually lasts half an hour. Opening things is harder for me now, this was not an issue I had prior. I do not experience the joint pain while opening jars but it is still difficult for me. I have been taking B12 supplements for a few weeks now.
55 2021-06-29 pain in extremity This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant f... Read more
This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in left arm on Mar2021 at 09:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included levothyroxine sodium (MANUFACTURER UNKNOWN) 137 mg for unknown indication. On 18Mar2021 at 10:00, the patient experienced arm soar, headache, slight fever, tired and sleepy. Therapeutic measures taken for these events included treatment with Tylenol and sleep. The clinical outcome of the events arm soar, headache, slight fever, tired and sleepy were resolved on unspecified date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
55 2021-06-29 pain in extremity This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration on 17Mar2021, at 12:30 on left hand, as a single dose (at the age of 55 years) for COVID-19 immunisation. The patient medical history included asthma, hypertension, and high cholesterol. The patient was not allergic to medications, food, or other products. Concomitant medication included Irbersartan/ HCTZ (MANUFACTURER UNKNOWN) 150-12.5 mg and atorvastatin (MANUFACTURER UNKNOWN) strength 200 mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced very sore arm the night of the injection and on 18Mar2021, the patient experienced headache, severe body ache and swollen lymph nodes which caused a lot of pain in my armpit until three days after injection. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of painful arm, headache, general body pains and swelling of lymph nodes was recovered. No follow-up attempts are possible. No further information is expected.
55 2021-06-29 tremor allergic reaction; couldn't swallow; shaking; This is a spontaneous report received from a contactab... Read more
allergic reaction; couldn't swallow; shaking; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 55-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated, went on Sunday and had first Covid shot and they do not know if she had an allergic reaction or not. She went to ER and got prednisone and Benadryl. She was shaking (on an unspecified date) and got to where she could not swallow but they said there was nothing swollen. Stated, physician could not tell if she should get the second dose or not and told me to call you. Patient again stated, she should get the second dose of Pfizer vaccine or take Benadryl before getting the vaccine because she had an allergic reaction after the first dose and could not swallow (on an unspecified date). Therapeutic measures were taken as a result of allergic reaction, couldn't swallow, shaking. The outcome of events was unknown. Information on lot number/batch number was requested.
55 2021-06-30 weakness, pain in extremity Very strange rash on her right hand above the wrist and inside of the arm/ Rash on her left breast; ... Read more
Very strange rash on her right hand above the wrist and inside of the arm/ Rash on her left breast; Rash, several bumps as they are very itchy; Rash on her left breast which after few hours become like a very red blood; High fever; Muscle pain; Whole body was hurting/ everything was hurting; Swollen hands; Feet were hurting; Shivering; She did not have much power/ Shutting down; Very tired; Catching cold; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0168), via an unspecified route of administration in left arm on 16Jun2021 (at the age of 55-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736), via an unspecified route of administration on 26May2021 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. It was reported that, reporter stated, yes, she would like to report unusual reaction to the Pfizer that she got on 16Jun2021. Patient know that it was normal to have fever, shingles etc. but she got a very strange rash on her right hand above the wrist and inside of the arm on 17Jun2021. The rash look like a chicken pox. Rash, several bumps as they are very itchy on 17Jun2021, and she was not touching them and also, she have rash on her left breast which after few hours become like a very red blood on 17Jun2021. Still experiencing: Reporter stated, no. First was a high fever on 17Jun2021 and she felt like a muscle pain on 17Jun2021, everything was hurting like swollen hands on 17Jun2021, the feet were hurting on 17Jun2021, whole body was hurting on 17Jun2021. Patient got shivering and high fever on 17Jun2021. Patient took the Tylenol, she did not have much power on 17Jun2021. Patient was like a very tired on 17Jun2021 but in the few hours she have to repeat that Tylenol because the fever return it and in the evening in the same situation, she was shutting down on 17Jun2021, she had fever she have 101. Patient took the Tylenol, she took the nap. When she woke up, she noticed the rashes. It was in the afternoon. The rashes appeared on her right arm and on her breast. No fever she took the Tylenol at 8:00 clock. Patient slept without any problems during the night. Patient still feel like she was catching cold on an unspecified date in Jun2021, but it was like 20% not that much and she do not thought so she take Tylenol. This should be noted that itchy portion to warn other people taking the vaccine so that they would be aware of such things. No investigation assessment. The patient underwent lab test and procedure which included body temperature: 101 on an unspecified date in Jun2021. The patient was treated with Tylenol for the events shivering, feet were hurting, swollen hands, whole body was hurting/ everything was hurting, muscle pain, high fever. The outcome of the events rash, high fever, muscle pain, swollen hands, shivering was resolving and unknown for the other events. Information on lot/batch number was available. Additional information has been requested.
55 2021-06-30 bell's palsy Bells Palsy; lost mobility of my face including my eye; This is a spontaneous report from a contacta... Read more
Bells Palsy; lost mobility of my face including my eye; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0185), via an unspecified route of administration, administered in left arm on 15Jun2021 08:15 as dose 1, single (Age at vaccination: 55 year old) for covid-19 immunisation. Medical history included eczema, cyst in liver, known allergies for Peniccilin, shell fish, flu shoot, dye for ct scan, nuts, trees, pollen from an unknown date and unknown if ongoing. Concomitant medications included VITAMIN D taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced bells palsy, lost mobility of her face including her eye on 15Jun2021 11:00. It was reported that, Approximately 3hrs after received patients first vaccine she lost mobility of her face including her eye and was diagnosed with Bells Palsy after it was confirmed that she was not having a stroke. Therapeutic measures were taken as a result of events includes Prednisone 60 mg 1 tablet per day, Valacyclovir 3 per day. The outcome for all events was recovering.
55 2021-06-30 nerve injury, facial paralysis, limb paralysis Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome -... Read more
Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received 2nd dose of BNT162B2 Covid-19 vaccine, at the age of 55 years old, on 24Mar2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face. Ended up in hospital 19Apr2021. Outcome of the event was unknown. Information about the lot/batch number has been requested.
55 2021-06-30 nerve pain Hot pain spots on top and back of head progressing to an intense nerve pain over two weeks moving f... Read more
Hot pain spots on top and back of head progressing to an intense nerve pain over two weeks moving from head down the back.; Hot pain spots on top and back of head progressing to an intense nerve pain over two weeks moving from head down the back.; sleepness nights; a burning pain at top of vertebrae with a swelling feeling inside the head; a burning pain at top of vertebrae with a swelling feeling inside the head; This is a spontaneous report from a contactable consumer reporting for herself. This 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3247) at single dose in left arm at age of 55-year-old on 02Apr2021 11:00 for COVID-19 immunization. The first dose was on 05Mar2021 11:00 in left arm, Lot number: EN6204, at age of 55-year-old. Medical history included endometriosis from 1999; trigeminal nerve neuralgia from 2011. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 15:00, patent had hot pain spots on top and back of head progressing to an intense nerve pain over two weeks moving from head down the back. Pain continued with similar intensity over the next 7 weeks causing sleepiness nights until treated with steroids at week 9 where sleeping became possible. Condition continued at week 10 but a burning pain at top of vertebrae with a swelling feeling inside the head. Steroid treatment was ongoing. The adverse events result doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The treatment received for the adverse events was gabapentin, acyclovir, prednisone. The outcome of events was not recovered. Follow up attempts are needed. Additional information can be requested.
55 2021-07-01 night sweats I had a concussion on December 30, 2020. I was still recovering from that when I got the vaccine a... Read more
I had a concussion on December 30, 2020. I was still recovering from that when I got the vaccine and I had the Zambia injections 3 weeks before the first shot. So I think it was a coincidence that it happened after the vaccine. The most bothering thing is the night sweats.
55 2021-07-01 night sweats Oxygen saturation low; Night sweats; Diarrhea; Nausea; wheeze at the end of her exhale; severe heada... Read more
Oxygen saturation low; Night sweats; Diarrhea; Nausea; wheeze at the end of her exhale; severe headache; Fatigue; Chills; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number: Unknown), via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 13:40 as 2nd dose, single for covid-19 immunization. Medical history included lipoedema (Adipose fat disorder) from 2017. The patient's concomitant medications was not reported. Historical vaccine of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number: Unknown), via an unspecified route of administration, administered in upper left shoulder on 13Feb2021 as 1ST DOSE, SINGLE, vaccinated at the age of 55 years for covid-19 immunization. She called about the covid vaccine and reported that she had no luck and had been sick for 10 days with sort of vaccine side effects and covid symptoms. All of the symptoms started 2 weeks after the second dose. On 14Mar2021, She had severe headache which was relieved by migraine medication, the headache came back when the medication wears off. On same day, she had chills. The chills have gone away. She also had a wheeze at the end of her exhale that she noticed really at night, she heard her breathing but did not know how to explain it. On 15Mar2021, she had nausea. Nausea improved when the headache went away. On 17Mar2021, She had diarrhea. The diarrhea went back and forth. 5 days ago on 18Mar2021, she started having night sweats but they happened early in the morning she wakes up in a puddle of sweat. On 19Mar2021, her oxygen saturation was low. It was reported that she had virtual doctors appointment. The patient's oxygen saturation was low on 17Mar2021 which was 90% lowest, 95% highest, she had been checking it at home with her pulse ox. On same day, she underwent sars-cov-2 antibody test which was negative. The outcome of severe headache, fatigue, Night sweats, Nausea, Diarrhea and Diarrhea was not recovered. Severe headache was reported as worsened. The outcome of Chills and Oxygen saturation low was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-07-01 tingling Patient complained of tingling in neck and throat area. We administer 50mg of diphenhydramine orall... Read more
Patient complained of tingling in neck and throat area. We administer 50mg of diphenhydramine orally. Patient then complained of a lump in her throat that did not go away . We check her blood pressure it was 201/102. We then called 911. Patient was assessed and transported to hospital.
55 2021-07-02 pain in extremity Red hives on left hip, cheek, eye lid and nose; Painful arm; Red around injection spot; This is a sp... Read more
Red hives on left hip, cheek, eye lid and nose; Painful arm; Red around injection spot; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2((PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number-ER2613) via an unspecified route of administration in the left arm on 22Mar2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer 13 years ago. The patient had a history of allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive medications within 2 weeks of vaccination. On 22Mar2021 at 20:00, the patient had experienced painful arm and redness around injection spot. On 23Mar2021 in the second day morning, the patient had red hives first on left hip, then on cheek, eye lid and nose in the afternoon. No therapeutic measures were taken. Adverse event resulted in emergency room/department or urgent care. The clinical outcome of the events painful arm, red around injection site and red hives on left hip, cheek, eye lid and nose were not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
55 2021-07-04 discomfort A golf ball size swollen lymph node in the armpit and then on day two it tripled in size and traver... Read more
A golf ball size swollen lymph node in the armpit and then on day two it tripled in size and traversed down the entire axillary area. On day two I also had soreness at site of injection and some pain. It was difficult lifting my arm. My fiancée who was a medic for 30 yrs did research online and found this had been reported during some tests. He agreed to watch it closely and marked border areas to ensure no spreading/growth. We closed my business for 7 days & It cleared up after a week gradually improving each day until resolved...utilized some Motrin to treat duscomfort. FYI I have a mammogram later this week. He us adamant I get this on file as May gave future impact if boosters needed later, as such he is filling this out for me.
55 2021-07-04 seizure patient suffered a 2-minute long seizure. She has a history of known seizure disorder. Her last seiz... Read more
patient suffered a 2-minute long seizure. She has a history of known seizure disorder. Her last seizure was 3 months ago. She also suffers from severe anxiety. patient was alert and oriented times 3 and refused transport to a local hospital by EMS. She left.
55 2021-07-05 difficulty speaking Throat tight. Patient stating inflammation in throat and changes in voice. Rash at administration si... Read more
Throat tight. Patient stating inflammation in throat and changes in voice. Rash at administration site. Shortness of breath, Puffy face
55 2021-07-05 pain in extremity Patient has been experiencing arm soreness/pain described as being more in the muscle than the shoul... Read more
Patient has been experiencing arm soreness/pain described as being more in the muscle than the shoulder since the vaccination occurred. Patient has been doing exercises and has seen her MD regarding the soreness. Has not improved significantly with time.
55 2021-07-06 burning sensation, nerve pain I felt burning sensations at the top of my head. It kind of stayed there and intensified from burnin... Read more
I felt burning sensations at the top of my head. It kind of stayed there and intensified from burning pain to nerve pain by the 17th of April. Then I went to seek a doctor on May 3rd. No tests were performed on that date. Acyclovir was prescribed.
55 2021-07-06 difficulty speaking That day I woke up hoarse and with a headache and throat. And then I noticed the outbreak on my arms... Read more
That day I woke up hoarse and with a headache and throat. And then I noticed the outbreak on my arms and then on my legs. The first came on my back. And already in the whole body. Two appeared on my face, one on the left palpation and the other on the right eyebrows. Itching, inflammation and pain. I still have hives today, July 7.
55 2021-07-06 numbness, migraine, speech disorder, tremor first dose of covid vaccine 3/19/2021. Also reports slowing down of her thinking process and freque... Read more
first dose of covid vaccine 3/19/2021. Also reports slowing down of her thinking process and frequent word searching when talking. She had covid disease in 9/2020. It took her 6 weeks to recover partially. She continued to have headache, nausea and muscle weakness. Fatigue, dizziness/spinny sensation, headache, muscle weakness and tremors and nausea. Has history of obstructive sleep apnea diagnosed in 2010. Has not used CPAP device in 9 years. No vomiting or diarrhea no abdominal pain at present. No chest pain, no shortness of breath no fever no chills. No loss of sense of smell or taste. Last week she developed some numbness in 1 side of her face associated with the headache. She was evaluated at Hospital and was believed to have migraine headache as her CT scan of the head was unremarkable.
55 2021-07-06 pain in extremity, facial paralysis Soreness in arm starting the day of vaccination starting 6/28 eye twitching, 6/30 numb tongue follow... Read more
Soreness in arm starting the day of vaccination starting 6/28 eye twitching, 6/30 numb tongue followed by no taste, 7/2 facial paralysis
55 2021-07-06 tingling Left arm and then left hand began to tingle. Left inside mouth cheek began to swell. Slowly my tongu... Read more
Left arm and then left hand began to tingle. Left inside mouth cheek began to swell. Slowly my tongue, uvula, throat, and top of mouth began to swell and feel raw. I did not call for the medic. I must have been in shock from the reaction. I took a Benadryl tablet there and two more during that day. I developed hives on my left hand palm, one on my right palm, and a couple on both wrists. I took one Benadryl for each of the next three days and as needed during the next two weeks.
55 2021-07-06 restless legs syndrome, muscle spasms, migraine, tremor, weakness muscle spasm/jerking/twitching; confusion; cognitive impairment; dizziness; falls/falling; unable to... Read more
muscle spasm/jerking/twitching; confusion; cognitive impairment; dizziness; falls/falling; unable to do "daily activities"; chills; migraines; nausea; fatigue, exhaustion; weakness; sweating; horrible feeling of "sickness" EVERYDAY!; became carsick even though I was driving; felt in a daze; tremors; affected my RLS; memory loss; headaches; This is a spontaneous report from a contactable consumer or other non-health care professional. A 55-years-old non-pregnant female patient received BNT162b2 (COMNITARY, solution for injection, Lot No: EW0162), via an unspecified route of administration, administered in left arm on 13Apr2021 10:30 AM (at the age of 55-year-old) as dose 2, single for covid-19 immunization. Medical history included bipolar disorder, anxiety, autoimmune thyroiditis, panic disorder from an unknown date and unknown if ongoing. Patient had known allergies to sulfa, Augmentin, Zomig, naproxen. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: EN6208), via an unspecified route of administration in left arm on 19Mar2021 11:00 AM as dose 1, single for COVID-19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline hydrochloride (ZOLOFT); gabapentin (GABAPENTIN), lamotrigine (LAMOTRIGINE); sodium gualenate hydrate (GU) taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. On 14Apr2021 07:00 patient experienced fatigue, weakness, headache, chills, nausea, migraine, exhaustion, confusion, tremors, affected my RLS, memory loss, become carsick even through I was driving, felt in a daze, cognitive impairment, dizziness, fall/falling, sweating, muscle spasm/jerking/twitching, unable to do "daily activities" horrible feeling of "sickness" EVERYDAY!. Therapeutic measurers were taken for all events are antibiotics, ondansetron, nausea med, migraine med, IV, muscle relaxant, lor. All the events resulted for Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of events nausea, migraines, chills, sweating, muscle spasm/jerking/twitching, confusion, dizziness, cognitive impairment, falling, weak, fatigue, exhaustion, unable to do "daily activities" horrible feeling of "sickness" EVERYDAY! Recovered on unspecified date in 2021 and events became carsick even though I was driving, felt in a daze, tremors, affected my RLS, memory loss, headaches were not recovered. Information on Lot/Batch number was available. Additional information has been requested.
55 2021-07-07 numbness Pt. describes swelling in arm with lumps around axilla and mid upper ark States fourth and fifth fin... Read more
Pt. describes swelling in arm with lumps around axilla and mid upper ark States fourth and fifth fingers on left had are numb and weak.
55 2021-07-07 muscle spasms, pain in extremity DVT diagnosed; Continual pain; A red area appeared and extremely painful in brachial vein area of le... Read more
DVT diagnosed; Continual pain; A red area appeared and extremely painful in brachial vein area of left arm; A red area appeared and extremely painful in brachial vein area of left arm; Stayed hot in the injection site daily; Left arm cramped; This is a spontaneous report from a contactable other health care professional. A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: En5318), via an unspecified route of administration, administered in left arm on 22Jan2021 (at the age of 55-year-old) as single dose for COVID-19 immunization. Medical history included asthma and known allergies of Celebrex and Vioxx. Patient received any other concomitant medication within 2 weeks prior to the COVID-19 vaccine included bupropion hydrochloride (WELLBUTRIN) and ibuprofen (IBUPROFEN). Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: En0899), via an unspecified route of administration, administered in left arm on 04Jan2021 (at the age of 55-years-old) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Workplace clinic. Adverse event started on 22Jan2021 at 04:00 PM. The patient experienced left arm cramped and stayed hot in the injection site daily after 2nd vaccine. On 14Apr2021, a red area appeared and extremely painful in brachial vein area of left arm. On 20Apr2021, Ultrasound scan (US) performed and DVT diagnosed and continual pain since. The patient underwent lab tests and procedures which included ultrasound scan: DVT diagnosed on 20Apr2021. Patient visited to Emergency room/department or urgent care. Treatment received blood thinner Xarelto 20mg. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events deep vein thrombosis,pain,pain in extremity, Erythema,cramp in hand and vaccination site warmth cannot be totally excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
55 2021-07-07 cold extremities, hot flush Chills Fever Hot Flashes Headache Dizzy Nauseous Hand felt frostbite Fatigue Visions of me helping... Read more
Chills Fever Hot Flashes Headache Dizzy Nauseous Hand felt frostbite Fatigue Visions of me helping someone roll away the boulder at the tomb
55 2021-07-09 pain in extremity Site: Pain at Injection Site-Medium, Systemic: shooting pain on left arm-Severe, Systemic: Tachycard... Read more
Site: Pain at Injection Site-Medium, Systemic: shooting pain on left arm-Severe, Systemic: Tachycardia-Severe, Additional Details: palpitation, call to pharmacy that left hospita today after being hospital since thursday, they wanted to complete a ekg and stress test and refused, will consult wqith doctor and insurance, still not feeling well.
55 2021-07-10 feeling hot, weakness, tremor Swelling of throat a few minutes after injection Aches, fever for 3 to 4 days after injection Day 5 ... Read more
Swelling of throat a few minutes after injection Aches, fever for 3 to 4 days after injection Day 5 to 8, horrible stomach and intestinal pain, lack of being able to use legs/walk, trembling nervous system, very dizzy 2 months after to present, digestive issues, dizziness, fatigue, feeling hot, palpating heart, shortness of breath, joint pain and weakness, easily bruising
55 2021-07-10 pain in extremity Soreness in arm.; Could not lift or engage arm muscle without pain.; Lethargy.; Overall fatigue; Pai... Read more
Soreness in arm.; Could not lift or engage arm muscle without pain.; Lethargy.; Overall fatigue; Pain in legs; Pain in back.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 25Mar2021 at 16:00 (at the age of 55-years-old) as single for COVID-19 immunisation. The patient had no known medical history and concomitant medication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04Mar2021 at 16:00 (at the age of 55-years-old) as single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Mar2021 at 20:00, the patient experienced soreness in arm and was not able to lift or engage the muscle arm without pain. The patient also experienced overall fatigue, lethargy, pain in legs and back which was not sharp but just uncomfortable on 25Mar2021 at 20:00. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events soreness in arm, not able to engage muscle arm without pain, overall fatigue, lethargy, pain in legs and back pain were resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-07-11 pain in extremity Adverse effects of the first vaccine - Left arm - Fever 102 / Body aches worse than any flu ever. S... Read more
Adverse effects of the first vaccine - Left arm - Fever 102 / Body aches worse than any flu ever. Sick for three days. Several days to recover. Arm was sore for over a week. Adverse effects from second vaccine - right arm - 9 hours after shot on 6/4/21 - every joint in my body hurt for two days. My hands were the worst. All I could do was cry and hold them up. I could no even use them. I did not have a Fever. My arm was sore, but not as long. My hands have not stopped hurting since June 4th. They hurt ALL the time. I wake up 3-4 times a night because they hurt so much. I've missed work because of the pain. I am wearing compression gloves all the time. I have not had a chance to get to the Dr. yet, but hope to go in the next week or so. I DID NOT HAVE THIS PROBLEM BEFORE THE MY SECOND VACCINE. They NEVER STOP HURTING. I was tested last year for Arthritis and did not have ANY of the markers for it. I was fine before this.
55 2021-07-11 tremor, weakness Pt. states received Phizer 1st dose 03/08/2021, sore arm, headache, and fatigue. Received 2nd Phizer... Read more
Pt. states received Phizer 1st dose 03/08/2021, sore arm, headache, and fatigue. Received 2nd Phizer shot 03/31/2021 and within a week started the fatigued, nauseous, heart palpations, stomach issues, tremors through the body, mood swings, issue with right eye (Cotton Wool Spots), weight lost, heat intolerance, weakness. Diagnosed with Graves Disease, 6 weeks of treatment. Beta-blockers prescribed. Most of the thyroid symptoms have went away, anti-thyroid medications have resolved underlining issues.
55 2021-07-12 weakness dizziness; weakness; headache; chills; nausea; tiredness; This is a spontaneous report from a contac... Read more
dizziness; weakness; headache; chills; nausea; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 25Mar2021 at 08:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 and reported that the patient had known environmental and food allergies. Concomitant medications included penicillin (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN) and naproxen sodium (ALEVE), all for unknown indication from unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 20:30 (12 hours later), the patient experienced dizziness, weakness, headache, chills, nausea and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events dizziness, weakness, headache, chills, nausea and tiredness was resolving (also reported that all the events lasted for 48 hours). No follow-up attempts are needed. No further information is expected.
55 2021-07-12 feeling hot Hives; heat that comes from inside body that itches; itching from the inside like poking through ski... Read more
Hives; heat that comes from inside body that itches; itching from the inside like poking through skin; bruises; broken skin; skin raises up and spreads all over and gets bigger and bigger and gets more itchy and scratches more and skin breaks; This is a spontaneous report from a Pfizer sponsored program. A 54-year-old female contactable consumer (patient) reported. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 29May2021 (age at the time of vaccination was 55-year-old) as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Left on 19Jun2021 (Batch/Lot number was not reported) as dose 2, single to prevent getting covid and my kids wanted me to get it (reported verbatim). Medical history included flushing and allergy to chemicals from an unknown date and unknown if ongoing (Caller states that she is allergic to alcohol and she has the Asian flush). Hysterectomy from an unknown date and unknown if ongoing (She had a hysterectomy 17 years ago). Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. The adverse events following prior vaccinations was reported as none. She states the only medication that she added is Metamucil powder in her smoothie every other day. She says she is pretty healthy. She has family members that also have Asian flush. She states she has several cousins who drink beer and then have red face but no hives. She has not had alcohol since she was 19 years old because she states if she does, she has to pay for it big time). Concomitant medications included plantago ovata (METAMUCIL [PLANTAGO OVATA]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other medication prior to COVID-19 Vaccine. The patient did not experience any adverse event prior to COVID-19 Vaccine. On 29May2021, the patient reported that she had her first dose, and she was unsure what was going on, so she waited 5 weeks to see if she was thinking correctly. The caller stated she felt a heat that comes from inside her body that itches, and she scratches it without knowing and itching from the inside like poking through skin. She wakes up with hives, bruises (Hours later she notices bruising), and broken skin. She reported that skin raises up and spreads all over and gets bigger and bigger and gets more itchy and scratches more and skin breaks. Hours later she notices bruising. She stated that she was allergic to alcohol and that this happened when she comes into contact with it. Caller states she got the first vaccine on 29 May 2021 and she waited 5 weeks to get the second vaccine on 19 Jun 2021. She did not want to make her reaction worse. She states her pharmacist told her this was ok. Caller stated she does not know what was in the vaccine. She just wanted to call in and let us know just in case someone else has the same problem as her. Caller stated she was part of the study. She stated that anyone like her should be aware of this. Caller stated she asked pharmacist about events and was told to go to emergency room for testing. Caller stated that the ER said there is nothing to test. She stated she went to ER and told doctor her race, and most had Asian flush which was lack of digesting alcohol. She said ER could not give her steroids because of COVID, might counteract the vaccine. Caller said the ER doctor did not have information since COVID was only 6 months out. She was told to take Benadryl and use hydrocortisone. She says Benadryl makes her sleepy so she does not take it. Hydrocortisone does not help with the hives and didn't make the hives go away. Caller stated that her daughter got the same vaccine at the same place and did not have any problems. Treatment medication included cold shower, Benadryl, and hydrocortisone. She said Benadryl made her sleepy, so she did not take it. Outcome of all the events was reported as unknown. Information about batch no/lot no has been requested
55 2021-07-12 migraine I have become extremely exhausted and developed a migraine headache which occurred on 07/11/21.
55 2021-07-12 tingling, feeling hot Pins and needles acute; Warm feeling in arm; This is a spontaneous report from a contactable consume... Read more
Pins and needles acute; Warm feeling in arm; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730), in left arm on 26Mar2021 (at the age of 55-year-old), as single dose for COVID-19 immunisation. Patient had no medical history. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), armour thyroid, multi vitamins received within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient had not tested for COVID-19. The patient had no known allergies to any medications, food or other products were not known. On 26Mar2021 at 1300 the patient experienced acute pins and needles on left side of left arm and also had warm sensation inside the arm near injection site. After 3 days, the patient was still experiencing pins and needle occasionally. No therapeutic measures were taken as a result of the events The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pins and needle and warm sensation were resolved with lasting effects. No follow-up attempts are needed. No further information is expected.
55 2021-07-13 bell's palsy Bell's Palsy
55 2021-07-15 numbness Patient reported numbness in the left side of head and neck within one hour following COVID-19 vacci... Read more
Patient reported numbness in the left side of head and neck within one hour following COVID-19 vaccination. Patient reported this to clinic via telephone and was advised to go to a local urgent care facility. No other information available at this time.
55 2021-07-15 muscle spasms, pain in extremity, tingling, weakness 3 days after the 1st vaccine- inflammation in joints, pain in old injury locations, muscle, tendon p... Read more
3 days after the 1st vaccine- inflammation in joints, pain in old injury locations, muscle, tendon pain. Muscle spasms. Extreme for 2 weeks. Barely being able to walk in the mornings, Unable to do my normal daily runs. The following 6-7 weeks the pain continued ( not as extreme but not good) Endurance, strength, remained low. Fatigue I'm over 3 months since the vaccine(s)- Injection spot still feels like a torn muscle, endurance and strength still not back to normal, heaviness in breathing, fatigue. pain in chest during intense training days, achy tingling arms.
55 2021-07-15 tingling 3.2.21 super stiff and it hurts and a terrible headache 4.9.21 Shot #1 Feb NO SIDE EFFECTS Shot 2 -... Read more
3.2.21 super stiff and it hurts and a terrible headache 4.9.21 Shot #1 Feb NO SIDE EFFECTS Shot 2 -3 weeks after Next day neck was stiff and hard to move to either side x 3 days NOW CAN MOVE BUT STILL FEELS STIFF HA Comes and goes since 2nd shot Different spots Lingers on right if she lays down Nagging, squeezing No neuro sx in hand No LOC/DIZZINESS/FALLS DIDN'T REPORT 5/4/21 New Back pain 1 week, +2 mos h/o unprovoked neck and head pain Hurts to sleep, can't sleep sometimes Feels like she had a crick and has to pop it No more pains in legs 6/22/21 Pt called and stated she is still having neck stiffness, headache and back pain with arm tingling since she got the Covid vaccine in February. 7/14/21 Began having neck stiffness, HA, and tingling to left arm afterwards
55 2021-07-15 seizure, inability to speak On January 4, 2021, started having events of not being able to speak, move or move y eyes, lasting 2... Read more
On January 4, 2021, started having events of not being able to speak, move or move y eyes, lasting 2-15 minutes, daily. Emergency room visit on January 6, r/o stroke- ruled out. On Jan 7th met with pcp, ordered MRI and see neuro. # trips to see 3 different neurologists multiple EEGs. Final diagnosis, Non-epileptic seizures, reason unknowm.
55 2021-07-16 inability to speak Exacerbation of dysautonomia. Symptoms different from previous events, more severe, and have lasted ... Read more
Exacerbation of dysautonomia. Symptoms different from previous events, more severe, and have lasted for over 2 months. Symptoms include stuttering, difficulty word finding, concentration difficulties, exhaustion, dizziness, occasional confusion. Initial event was significant, lasted for 2 hours, during which I was able to hear as if at a distance, but unable to see, and did not have motor control to respond. Since then, vagal symptoms have occurred with regularity, are not always relieved by usual measures. Underwent full cardiac workup including Holter monitor, EKGs, echocardiogram, lab work, including CBC comprehensive metabolic. Also ACTH and cortisol. All were within normal limits. Was then evaluated by neurology. General exam was within normal limits, sleep-deprived EEG was normal. Head CT, head MRI both normal. Fludrocortisone 0.1 mg daily added to medication regimen. After one month midodrine 25 added to regimen. Symptoms have improved to the point that 30 to 40 hour work week now possible. However symptoms do persist, and an episode has never lasted this long in the 20 years I have had this diagnosis. Nor have symptoms ever been this severe.
55 2021-07-17 weakness, tremor On Friday, 4/9, I experienced a fever of 103.3, sore throat, earache on the left side, swelling on t... Read more
On Friday, 4/9, I experienced a fever of 103.3, sore throat, earache on the left side, swelling on the neck and face, swollen tonsils, white stains on my tonsils, headache, toothache, and terrible muscle pain. When I went to the emergency room on 4/10, I received a dose of dexamethasone 15ml and was instructed to take Tylenol. On 4/11, I had no further symptoms after taking the dexamethasone. On 4/12 in the AM, my fever (101.4 F), sore throat, earache on the left side, toothache, headache, more swelling on the neck started to occur. I took Tylenol for the symptoms.; I was feeling very tired and weak the entire time and experienced severe dizziness. On 4/13, my body started to bruise up on the left side of my body (foot). Then, I developed a bruise on my left shin and left hand. I had severe tremors and shakes. I went back to the emergency room on 4/13 and lost consciousness in the waiting room. My left tonsil started to develop black spots on it. My doctors at the emergency room did not know what this was. I was given dexamethasone via IV and clindamycin 150MG X3/day X 6 days. On 4/13, my left buttocks developed shingles. On 4/16, I had a visit at my doctor's. I still had swelling on the face and neck, my bruises grew in size. My doctor prescribed me Valacyclovir 1gm X1 tablet X 3/day X 1 week. From 4./16, these symptoms persisted for about 10 days before I began to feel better.
55 2021-07-17 weakness Dry mouth; Throat was burning/ burning sensation in her throat; Couldn't eat; Drank one water and fe... Read more
Dry mouth; Throat was burning/ burning sensation in her throat; Couldn't eat; Drank one water and felt like she needed more so she drank 5 bottles of water; She couldn't really walk; Felt very achy/ lot of pain; Felt out of it/ feeling horrible/ feeling yucky; Weak; Couldn't eat anything, didn't have an appetite; Dizzy/ dizziness; Vomited; Headache; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: ER8735, expiry date: unknown) via an unspecified route of administration on 07May2021 at 11:15 (at the age of 55-years-old) in upper right arm as DOSE 1, SINGLE FOR COVID-19 immunization. The patient's medical history (including any illness at time of vaccination) and concomitant medications were not reported. Historical vaccine included prior vaccination of flu shot in fall. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, adverse events following prior vaccinations, family medical history relevant to adverse events were reported as none. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No investigation assessment was reported. The patient reported that she received the vaccine in the morning on 07May2021 at 11:15 and did not feel anything at all and then she sat there for 20 minutes at vaccine center, they said to wait to see if there was a reaction. She was fine so she went home and did her usual activities. She went to the store, she was at work then and got seafood at 18:00. She went home at 22:00, she eat some shrimp and fish, seafood-like stuff, went to bed. She felt fine immediately after eating seafood, then overnight at like 03:00 on 08May2021, she woke up and felt out of it, felt horrible, like very achy, weak, dry mouth, throat was burning, lot of pain and just dizzy. She nudged her husband and told him to get her water and he got her water, drank one and felt like she needed more so she drank maybe 5 bottles. She woke up a little bit later, she could not really walk because she felt so weak, so he had to help her to the bathroom and that's when she vomited. She went back to sleep and the next day, she could not eat anything, felt bad and didn't have an appetite. She had early morning vomiting, then she woke up 08May2021 and it was all that day, she did not feel like eating and had headache then went to bed. She went to bed feeling yucky and then when she woke up on 09May2021, she felt normal again. She did not require emergency room and physician office visit. She was just wondering if those symptoms could be from the food or if it could have been from the vaccine as it just happened the same day or was a coincidence. She does not think she needs to worry about getting the doctor involved, she just had that one episode and felt fine. Relevant tests were reported as none. The patient was scheduled for second dose on 28May2021. The outcome of all the events was resolved on 09May2021. Information on lot/batch number was available. Additional information has been requested.
55 2021-07-17 burning sensation Sadness; Congestion; Really bad diarrhea; Kidney pain; Dizziness; Cough; Headache; Thirst; Difficult... Read more
Sadness; Congestion; Really bad diarrhea; Kidney pain; Dizziness; Cough; Headache; Thirst; Difficulty sleeping; Neck pain; I have burning in the back of my neck; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0191 Expiration date: unknown) dose 1 via an unspecified route of administration, administered in Arm Right on 06Jun2021 11:00 (at the age of 55-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. patient did not received any other medication within 4 weak Prior to Vaccinations. The patient experienced neck pain, headache, thirst, depressed mood, cough, and difficulty sleeping on 06Jun2021, have burning in the back of the neck on Jun2021, Really bad diarrhea, Dizziness, kidney pain, on 07Jun2021, Sadness, Congestion on 08Jun2021.neck pain: Caller states neck pain was almost immediate after vaccine.She believes this pain resolved about a week later. when probed for the outcome, the caller explains she was okay right now. She feels she has recovered completely, Burning in the back of the neck started about two to three days after the vaccine, Headache: was almost immediate and resolved about maybe two weeks later, Thirst: Was almost immediate. She was drinking a lot of water.The thirst resolved maybe 2 weeks later. She has been hydrating on and off with Gatorade, Powerade and of course water, diarrhea: lasted about a week and a half, Cough: Was almost immediate. It was about maybe three hours after the vaccine, Dizziness: Resolved probably about two weeks later. The outcome of event Neck pain, Headache, Thirst, Sadness, Dizziness Recovered on Jun2021, outcome of burning in the back of my neck, recovered on 12Jun2021, while outcome of event Kidney pain, Congestion, Cough, Difficulty sleeping not recovered, outcome of other events was unknown No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021820899 similar report from same reporter
55 2021-07-17 muscle spasms Bad headache; Severe body aches; severe joint pain; nausea; lite headedness; spasms on legs, arms a... Read more
Bad headache; Severe body aches; severe joint pain; nausea; lite headedness; spasms on legs, arms and back.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 26Mar2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were reported as pre/probiotics (MANUFACTUER UNKNOWN) and women multivitamin (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021 at 23:00, the patient had side effects that was as bad as when she had COVID in Dec2020. The patient experienced bad headache, severe body aches, severe joint pain, nausea and some light-headedness. The new symptom that was severe as well was spasms. The patient experienced really bad spasms on her legs, arms and back. They had been hurting so bad that the patient could not even touch them. It was reported that the patient felt like she had all the symptoms of COVID. It had been two days but still the patient felt awful. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. The clinical outcome of headache, general body pain, joint pain, nausea, light-headedness and spasms was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
55 2021-07-17 pain in extremity Muscle pain; Joint pain; she was having pain in her left side and that went to her leg, when she was... Read more
Muscle pain; Joint pain; she was having pain in her left side and that went to her leg, when she was walking it hurt; she was having pain in her left side and that went to her leg, when she was walking it hurt; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 18Jun2021 (Lot Number: EW0185) as dose 2, single at the age of 55-year-old for covid-19 immunisation. Concomitant medications were not reported. Historic vaccine was bnt162b2 received via an unspecified route of administration, administered in right arm on 28May2021 as dose 1, single at the age of 55-year-old for covid-19 immunization. The patient got her BioNTech Covid-19 Vaccine first shot on "2852021" (not clarified) and got her last (dose) on 18Jun2021. Since she had Covid vaccine she had muscle pain and joint pain like that. She did not know what was wrong about with her left she was having pain in her left side and that went to her leg, she did not know what was causing. She was applying cream (treatment) just while ago, she had muscle pain and joint pain and she was not sure. She was trying to figure out what was causing. When probed for event start date, the patient stated, she saw this pain about 3-4 weeks ago. (Further not clarified. Hence, not captured in the tab). The patient added, That was all she was not worried and she was just confirming that she said just kind of when she was walking it hurt, she wanted make sure if not vaccine was causing it. No any prior vaccination. Therapeutic measures were taken as a result of events which included cream. The outcome of events was not recovered.
55 2021-07-17 pain in extremity Pepper spray feeling in mouth; Numbness around lips; Slight tightness of throat; Headache; Jaw pain;... Read more
Pepper spray feeling in mouth; Numbness around lips; Slight tightness of throat; Headache; Jaw pain; Ear pain; Chills; Neck stiffness; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Er8733), via an unspecified route of administration in the right arm on 30Mar2021 at 09:00 (at an age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient had an allergic reaction to ocrelizumab (OCREVUS). The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 30Mar2021, about 5 to 10 min after vaccine, the patient experienced pepper spray feeling in mouth, numbness around lips, slight tightness of throat, headache, jaw pain and ear pain. 12 hrs later, the patient still felt the same, but experienced chills, neck stiffness, arm pain. The events resulted in emergency room/department or urgent care visit. The patient did not receive any treatment for reported events. The clinical outcome of events pepper spray feeling in mouth, numbness around lips, slight tightness of throat, headache, jaw pain, ear pain, chills, neck stiffness, pain in arm were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
55 2021-07-17 pain in extremity Overnight soreness in left arm; This is a spontaneous report from a contactable consumer, the patien... Read more
Overnight soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via an unspecified route of administration in the left arm on 29Mar2021 at 12:15 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 29Mar2021, the patient experienced overnight soreness in left arm. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the overnight soreness in left arm. The clinical outcome of the event overnight soreness in left arm was resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
55 2021-07-17 tingling, weakness, discomfort, numbness, feeling hot Weakness; Warm heating sensation in body mostly in breast; pressure between shoulder blades; Swollen... Read more
Weakness; Warm heating sensation in body mostly in breast; pressure between shoulder blades; Swollen arms; Blue/ grey spots on upper thigh; Heaviness in arms; Pressure in head; Tingling sensation in head; Numbness in left arm fingers; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in left arm on 03Mar2021 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in left arm on 08Feb2021, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Mar2021, the patient experienced weakness, warm heating sensation in body mostly in breast, pressure between shoulder blades, swollen arms, blue/ grey spots on upper thigh, heaviness in arms, pressure and tingling sensation in head, and numbness in left arm fingers. It was reported that patient was seen by primary care provider, emergency room department, infectious disease specialist and rheumatologist. No answers to what was happening, other than this could be a reaction to the vaccine. The patient reported that, it was 22 days since received second Pfizer shot and was still in pain, she felt like a different person and not getting any help or find answers to what was going on. The events resulted in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the events. The clinical outcome of events weakness, sensation of warmth, sensation of pressure, swollen arm, spot pigmented, heaviness in arm, head pressure, tingling sensation and numbness in fingers was not resolved. No follow-up attempts are needed. No further information is expected.
55 2021-07-17 tingling 1 hour after receiving the injection I had black spots in my left eye, I got lightheaded, my vision ... Read more
1 hour after receiving the injection I had black spots in my left eye, I got lightheaded, my vision was affected while watching TV. I took 2 Tylnenol and layed down on the couch. I also had a tingling sensation in my left armpit lymph nodes and down into my left arm. The black spots & lightheadedness went away in about an hour. Generally so did the left arm sensations. The injection site was mildly sore for about a week.
55 2021-07-17 tremor Light headed; Shaking; Elevated HR beating so fast it would wake her up in the middle of the night; ... Read more
Light headed; Shaking; Elevated HR beating so fast it would wake her up in the middle of the night; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program support via information team. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization at the age of 55-year-old. The patient medical history and concomitant medications were not reported. The patient experienced light headed, shaking, elevated heart rate (HR), beating so fast it would wake her up in the middle of the night on an unspecified date in Apr2021. The patient stated that the symptoms lasted close to two weeks. The outcome of events was recovered on an unspecified date in Apr2021. Her doctor recommended she wait to receive the second dose of the vaccine. Information on the lot/batch number has been requested.
55 2021-07-18 breast pain No immediate issues noticed with the first shot on 1/19 other than a heachache and pain between by b... Read more
No immediate issues noticed with the first shot on 1/19 other than a heachache and pain between by breast on 1/28. Scheduled stomach and pelvic US and found nothing. Breast became enlarged resulting in an infection and scar tissue development. Removal of scar tissue and implant was required and not paid by insurance. I believe the Covid cause this as I was 100% healthy other than a migraine once a month. Rapid heart rate occurred when sitting down or when slowly jogging. Could feel the heart beat skip. I would like to know if this has occurred to healthy woman.
55 2021-07-18 tingling Vaccine administered approximately 5 pm on 7/12/2021 in left arm. Felt left arm tingle right after ... Read more
Vaccine administered approximately 5 pm on 7/12/2021 in left arm. Felt left arm tingle right after injection, within 24 hours throat and epiglottis areas felt swollen and had red and white blotches/sores in throat, around uvula, tonsils and surrounding tissues in mouth. Lips a bit tingly as well. Felt very fatigued. As days passed, throat sores increased and migrated on roof of mouth and towards lip region and inside of upper lip had red sores that looked bloody and lips with some swelling and tingling. today, 7/19/21, one week after vaccine was given, throat and lips are almost back to normal, but not quite-still with some mild upper lip irritation, swelling and redness and mild throat irritation and blotches but to a much lesser degree. Did some warm water salt rinses throughout the week, rested, took Advil or tylenol. I did not go to the doctor's office.
55 2021-07-19 pain in extremity Sore arm had trouble breathing about a hour after
55 2021-07-19 tingling, burning sensation constricted throat; Body and muscle aches; Feverish, but no fever; Body and muscle aches; the pins a... Read more
constricted throat; Body and muscle aches; Feverish, but no fever; Body and muscle aches; the pins and needles feeling, and the red hands; pins and needles feeling, and the red hands; burning and tingling sensation in the legs and back; burning and tingling sensation in the legs and back; the pins, needles, and burning sensation on the bottom of her feet; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (Batch/Lot number:ER8730 & Expiry date not reported) via unspecified route of administration in left arm on 26Mar2021 16:10 (at age of 55-year-old) as dose 2, single for COVID-19 Immunization. Patient medical history and concomitant medications not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (Batch/Lot number: ENG202, Expiry date not reported) via unspecified route of administration in left arm on 26Feb2021 (at age of 54-year-old) as dose 1, single for COVID-19 Immunization. On 26Mar2021, Patient experienced had a severe reaction, but it did not require and epipen. She ended up in the emergency department and required Benadryl as she had a constricted throat. Her symptoms resolved as soon as she received Benadryl and steroids via IV. Patient after returning home she had severe body aches and muscle aches to the point that getting to the bed from her recliner was difficult, and she was down all weekend. She felt feverish but did not have a fever. She checked her temperature, and it was 98F. On an unspecified date in Mar2021, Caller states she had pins and needle feeling, and burning and tingling in her legs and back. In addition to the bottom of feet, she also had pins, needles, and a burning sensation that lessened as of this morning. Caller states the pins and needles feeling, and the red hands are ongoing since the first covid19 vaccine, on26Feb2021, and are persisting since the second covid19 vaccine. Caller states the burning and tingling sensation in the legs and back were ongoing since the first covid19 vaccine and worsened since the second covid19 vaccine. Caller also states the pins, needles, and burning sensation on the bottom of her feet started 3 weeks after the first covid19 vaccine, on 19Mar2021, and the sensation worsened after the second covid19 vaccine and was ongoing. Patient was referred to allergist. Patient underwent lab test and procedure include body temperature was 98F on unspecified date. Treatment received for constricted throat. The Outcome of events was constricted throat recovered on 26Mar2021, Feverish, but no fever recovered on 27Mar2021, body aches and muscle aches are recovering, and other events are not recovered. No follow-up attempts are possible. No further information is expected.
55 2021-07-20 numbness, nerve injury, burning sensation HIGH glucose levels (338-550), Nerve damage (burning in feet and legs, numbing in hand(L). Insulin i... Read more
HIGH glucose levels (338-550), Nerve damage (burning in feet and legs, numbing in hand(L). Insulin increased by 20%. Nerve test performed. Still having nerve problems to this day (requiring nerve pain medication).
55 2021-07-20 numbness, tingling fter 20 minutes in the observation area on 5/15/2021, client reported numbness and tingling in both ... Read more
fter 20 minutes in the observation area on 5/15/2021, client reported numbness and tingling in both feet that progressed to the thighs. Client reported she was observed for 2 hours by vaccination staff. Mobility was unaffected and no intervention medications administered on-site. Client reported she went home and numbness and tingling resolved after 2 more hours. Client reported she woke up the next day with headache and chills, which she treated with a single dose of Tylenol. Headache and chills resolved over 3 days.
55 2021-07-21 hot flush, weakness I have been sick since July 16 at 8:00 pm I have been unable to work I felt so ill my husband took... Read more
I have been sick since July 16 at 8:00 pm I have been unable to work I felt so ill my husband took me to the Doctor on July 22 . They test me for Covid and flu and both were negative. I have been having chills hot flashes headaches joint aches and very weak
55 2021-07-21 night sweats Intolerance to heat; Night sweats; Stomach upset; High blood pressure; Nausea; Chills; Slept all day... Read more
Intolerance to heat; Night sweats; Stomach upset; High blood pressure; Nausea; Chills; Slept all day; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: LAB-1451-0.7) via an unspecified route of administration in the left arm on 23Mar2021 at 14:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, prehypertension, anxiety, diverticulum, ulcers, vertigo, shingles, palpitations, herpes simplex type 1 and 2, gastroesophageal reflux disease (GERD) and hiatal hernia. The patient had received other unspecified medications within 2 weeks of vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the day of vaccination the patient slept all day. On 30Mar2021 at 13:00, day 7 after vaccination, the patient experienced intolerance to heat, night sweats, nausea, stomach upset, chills and high blood pressure. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome slept all day, intolerance to heat, night sweats, nausea, stomach upset, chills and high blood pressure were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
55 2021-07-21 pain in extremity I received the injection on a Friday morning. During the night I had fevers, chills and headache an... Read more
I received the injection on a Friday morning. During the night I had fevers, chills and headache and my arm was sore for about 4 days. In the afternoon on Saturday I broke out in hives. It started in my knee pits and elbow pits. Latter it moved up the back of my legs, around my leg joints, across my stomach, around my breasts, in my armpits and then a few days later on my lips and neck. Even to my hands and feet. It increased in severity in the heat. I took Benadryl or allergy tablet for days. I called the Dr on Tuesday and they prescribed a Z-pack with prednisone for 6 days. I still had to take the allergy pills. When those finished I was not better. I called the dr. the following week and they put me on 10 mg prednisone for 10 days and 5 mg for another 10 days (I have a few days left of it). It has helped somewhat but then on 7/17/2021 I broke out in hives again, but they have not been as severe, but still have to take a 24- allergy bill about every other day
55 2021-07-22 feeling hot, tremor 50 hours after shot, had waves of agitation; mild panic; sadness; later fever; shaking; Not right; e... Read more
50 hours after shot, had waves of agitation; mild panic; sadness; later fever; shaking; Not right; elevated pulse; Things looked like tunnel vision sort of; A few minutes after vaccine, starting feeling harder to breathe & felt a warm clammy wave starting from my waist & rising up. Things looked like tunnel vision sort of. My sister told me I was having; A few minutes after vaccine, starting feeling harder to breathe & felt a warm clammy wave starting from my waist & rising up. Things looked like tunnel vision sort of. My sister told me I was having; She was having a panic attack; had 2 episodes of diarrhea; a few brief waves of nausea,; 1 brief dizzy moment at one point which dissipated as I raised my head from looking down reading my tablet; I assumed all of those last symptoms were anxiety related; This is a spontaneous report from a contactable consumer, reporting for herself. A 55-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified rout of administration in right arm on 30Jun2021 01:00PM (at the age of 55-year-old) at single dose for COVID-19 immunisation. Relevant medical history included tachycardia (unspecified), sleep apnea (CPAP use), hypertension and high cholesterol (weaned off of atenolol to take vaccine and dieting to lower cholesterol). In addition, the patient was sensitive to dietary and external histamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atenolol, magnesium sulfate, vitamin D3, vitamin C and fish oil. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. A few minutes after vaccine (reported as 30Jun2021 at 01:00PM) the patient started feeling harder to breathe and felt a warm clammy wave starting from her waist and rising up. Things looked like tunnel vision sort of. Her sister told her she was having a panic attack. The patient held off on Epipen that she had asked doctor to prescribe and after a moment she assessed that she was still able to breathe. While staying in clinic for quite a while, the patient had two episodes of diarrhea, a few brief waves of nausea, one brief dizzy moment at one point which dissipated as she raised her head from looking down reading her tablet. The patient assumed all of those last symptoms were anxiety related. At 50 hours after shot, the patient had waves of agitation, mild panic, sadness, not right, later fever and shaking, elevated pulse. Outcome of the events was unknown. Information on lot/batch number has been requested.
55 2021-07-22 numbness, weakness, tingling Tingling in toes/feet initially, then tingling in hands - numbness in feet and hands, generalized we... Read more
Tingling in toes/feet initially, then tingling in hands - numbness in feet and hands, generalized weakness in the mornings
55 2021-07-22 migraine, weakness Very loud ear ringing in both ears as well as constant migraine
55 2021-07-22 tremor, weakness experienced mild wheezing.; experienced shaking hands and legs.; legs went weak; felt very nauseas/ ... Read more
experienced mild wheezing.; experienced shaking hands and legs.; legs went weak; felt very nauseas/ nausea was more intense; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0105) via an unspecified route of administration in the right arm on 01Apr2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, COVID-19. The patient had history of known allergies to molds, pollen, dust mites, drugs allergy: codeine (MANUFACTURER UNKNOWN) and (DURICEF). Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA) of 100mcg and loratadine (MANUFACTURER UNKNOWN) of 10mg tablet, all from unknown date for unknown indication and also previously second dose of varicella zoster vaccine rgE (CHO) (SHINGRIX) (Lot Number: 58160-0823-11 on 12Mar2021 for an unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 14:00, within five minutes of receiving the vaccine, the patient felt very nauseas, about 20 minutes after vaccine the legs went weak and nausea was more intense. Healthcare workers made the patient sit with feet propped up. About 30 minutes after vaccine the patient experienced shaking of hands and legs, about one hour after vaccine experienced mild wheezing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures included treatment with inhaler, consumption of snack and water. The clinical outcomes for nausea, shaking of hands and legs, mild wheezing and weakness of legs were recovering. No follow-up attempts are needed. No further information is expected.
55 2021-07-23 tingling His arm (from elbow to fingers) started tingling 15 min post receiving first dose of pfizer vaccine.... Read more
His arm (from elbow to fingers) started tingling 15 min post receiving first dose of pfizer vaccine. Lasted 10 min then it went away. Patient left after 30 min total of observation
55 2021-07-24 feeling hot Hives, swelling in face & throat, severe itching & heat
55 2021-07-25 weakness The pain was quite debilitating and not normal. The pain was coming from deeper inside than the bone... Read more
The pain was quite debilitating and not normal. The pain was coming from deeper inside than the bone versus the muscle. I was hospitalized for 4 days for a mysterious ear, nose and throat illness that I don't think it ever went away. I was in home care for 3 weeks taking medications after that. The side effects from certain medications I can no longer take.
55 2021-07-25 weakness cardiac arrest on 4/30 followed by medically-induced coma followed by bringing back to normal body t... Read more
cardiac arrest on 4/30 followed by medically-induced coma followed by bringing back to normal body temperature followed by recovery. in ICU almost a week and heart hospital a week. Nearly full recovery at this time. Going to cardiac rehab and working to build strength/stamina.
55 2021-07-25 pain in extremity I broke out in shingles after 3 days from getting the vaccination. My arm was bruised horribly and h... Read more
I broke out in shingles after 3 days from getting the vaccination. My arm was bruised horribly and hurt. For about 2 weeks I tasted metal in my mouth. 2 months later from June 23rd - June 26th I had post menopausal bleeding. I bleed very heavy from the 2-3 day 24 That was around the time I was exposed to Covid through my Husband. The doctor gave me Valtrex for 10day round.
55 2021-07-26 numbness Patient c/o itchiness in throat, given 25mg Benadryl, Vitals 176/82, Pulse 82, O2 98%, Patient trans... Read more
Patient c/o itchiness in throat, given 25mg Benadryl, Vitals 176/82, Pulse 82, O2 98%, Patient transferred to gurney, no any symptoms of stroke, BP checked again after 10 minutes BP 150/90, Pulse 70, After 5 minutes patient c/o numbness on left side of face, no drooping noted, 911 called for suspected stroke, Patient notified husband by phone herself, Patient taken by ambulance to Hospital for further evaluation
55 2021-07-26 tingling Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Pt received benadr... Read more
Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Pt received benadryl and tongue and lip tingling resolved
55 2021-07-26 unresponsive to stimuli Patient came for first dose Pfizer (LOT#: EW0175 exp: 8/2021). Patient alerted security guard and s... Read more
Patient came for first dose Pfizer (LOT#: EW0175 exp: 8/2021). Patient alerted security guard and stated that she felt dizzy. Security guard sat patient down in a chair and alerted EMT. Patient stated that she was feeling dizzy. EMT took patients vital signs. BP: 136/78, HR: 95, O2: 99%. PHN assessed patient. Patient stated that her chest first started hurting and then she felt dizzy and that was when she alerted the security guard about not feeling well. Patient stated that she felt pressure in her chest for approximately 2-3 seconds. PHN and EMT asked patient if she could walk to anti-gravity chair. Patient agreed she could. PHN and EMT helped patient stand up. PHN asked patient to stay standing. Patient asked to sit back down because she felt dizzy. Patient was not verbally responsive and was not oriented to time. PHN asked patient how she was feeling. Patient stated that she felt like everything went black for approximately 2-3 seconds and she felt dizzy. At 1612 patient was placed on anti-gravity chair. RN called 911 at 1614. EMS arrived on scene at 1416. Patient vital signs were taken. BP: 150/78, HR: 91, O2: 95%, blood glucose: 377. Patient decided to go to emergency room with EMS due to high blood glucose. Patient left on a gurney with EMS at 1627.
55 2021-07-27 weakness High fever; Severe headache; Bad vision.; Body aches.; No energy; Nausea; slept 20 hours; This is a ... Read more
High fever; Severe headache; Bad vision.; Body aches.; No energy; Nausea; slept 20 hours; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: Er8763) via an unspecified route of administration in the left arm on 24Apr2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received penicillin for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0150), via an unspecified route of administration in the left arm on 01Apr2021 at 13:00 (at the age of 55-years old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Apr2021 at 00:00, the patient had experienced high fever, severe headache, bad vision, body aches, nausea. She had slept for 20 hours and did not have energy. Five days later she was still sick. The clinical outcome of the events high fever, severe headache, bad vision, general body pains, no energy, nausea and slept 20 hours was resolving at the time of report. No follow-up attempts are needed. No further information is expected
55 2021-07-27 difficulty speaking Sick since getting first dose; I came down with flu symptoms in the middle of the night.; Body aches... Read more
Sick since getting first dose; I came down with flu symptoms in the middle of the night.; Body aches; headache; throat swollen and scratchy. Voice.; throat swollen and scratchy. Voice.; My head is pumped up.; Sore throat; Throat swollen scratchy and hardly talk.; This is a spontaneous report received from a contactable consumer (patient). A 55-Year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 03Jul2021 as dose 1 single (at the age of 55-Year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that she was sick since getting first dose on 03Jul2021. On an unspecified date in 2021, She came down with flu symptoms in the middle of the night. Body aches, headache around Thursday mild throat swollen and scratchy Voice. Her head was pumped up. Taking Mucinex D, Aleve, Alternating Tylenol, and Night Quil. Barely Blood Boogers. Symptomatic when the medication wears out. Sore throat started third day. All of this triggered by that vaccine. Throat swollen scratchy and hardly talk. Got worse over the days. Patient was asking so you have the sore throat as a reported. Patient indicates she does not have a HCP. Patient previously gal went day by day. The outcome of the events was unknown. Information about batch/lot number has been requested
55 2021-07-27 facial pain Headache; sinus congestion; face and jaw pain; face and jaw pain; nausea; vomiting; This is a sponta... Read more
Headache; sinus congestion; face and jaw pain; face and jaw pain; nausea; vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 02Apr2021 at 13:00 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history included allergy to allium and lactose intolerance. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 12Mar2021 at 13:30 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 06:00, the patient experienced headache, sinus congestion, face pain, jaw pain, nausea and vomiting. The patient did not receive any treatment for these events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events headache, sinus congestion, face pain, jaw pain, nausea and vomiting was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
55 2021-07-27 pain in extremity, weakness Stinging throat; Swollen neck; Sore arm; Nausea; Dizzy; Very weak; Ear ache; Light sensitivity; Body... Read more
Stinging throat; Swollen neck; Sore arm; Nausea; Dizzy; Very weak; Ear ache; Light sensitivity; Body aches; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733), via an unspecified route of administration in the left arm on 03Apr2021 at 14:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medication included levothyroxine sodium (SYNTHROID 175), vitamin B+ (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), vitamin E (MANUFACTURER UNKNOWN), all taken from unknown dates for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Mar2021 at 15:00, the patient experienced stinging throat, swollen neck, sore arm, nausea, dizzy, very weak, ear ache, light sensitivity and body aches. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events stinging throat, swollen neck, sore arm, nausea, dizzy, very weak, ear ache, light sensitivity and body aches was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
55 2021-07-27 pain in extremity has daily pain in her hands; having a flare up of psoriasis; This is a spontaneous report based on i... Read more
has daily pain in her hands; having a flare up of psoriasis; This is a spontaneous report based on information received by Pfizer from Novartis (mfr control no. NVSC2021US103908) a contactable consumer reported. A 55-years-old female patient received bnt162b2 (BNT162B2 Solution for injection), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced has daily pain in her hands and having a flare up of psoriasis on an unspecified date. Patient stated having a flare up of psoriasis after taking the COVID vaccine also has daily pain in her hands. The outcome of the events was unknown. Follow-up needed. Information about batch/lot number has been requested.
55 2021-07-27 tingling within minutes tingling of face, slight headache. Later in the day metal taste in mouth. Tingling ... Read more
within minutes tingling of face, slight headache. Later in the day metal taste in mouth. Tingling in face didn't stop until in the evening
55 2021-07-28 facial pain she grinds her teeth; Second dose: severe pain in the right side of her face; Second dose: right sid... Read more
she grinds her teeth; Second dose: severe pain in the right side of her face; Second dose: right side of her face has stayed swollen and sore; Second dose: right eye is sore; her right temple is sore; Second dose: slight deviated septum; woke up in the middle of the night again with horrible pain; Second dose: brain felt like it was to big for her skull; Second dose: her eyes felt like they were going to fall out; Second dose: vomiting; Second dose: diarrhea; Second dose: resting heart rate of 97 beats per minute which is around 30 beats per minute higher than her normal resting heart rate; Second dose: chest pain; Second dose: mouth hurt horribly/still having an issue waking up in pain; next day after receiving the second dose she was definitely sick/ungodly sick; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 14Apr2021 15:40 (at the age of 55-year-old) (Batch/Lot Number: EW0153; Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. Medical history included reduce acid (hyperacidity). Concomitant medication included omeprazole taken as acid reducer. The patient received first dose of Shingrix on 19Jun2020 as immunization and experienced arm was extremely sore/ caused a really really really sore arm and second dose of Shingrix on 31Aug2020; flu vaccine on 23Nov2020; and first dose of bnt162b2 for covid-19 immunisation on 23Mar2021 and experienced soreness at the injection site that was pretty minimal; and she stated she felt fine after getting both doses of the vaccine. On 15Apr2021, the next day after receiving the second dose, she was definitely sick, she almost called an ambulance. She had rescheduled a dental appointment 12 days after the 2nd dose to have a cavity filled and she was given Novocain at both dental appointment on 26Apr2021 and 28Apr2021. The day after, on 27Apr2021, she felt ungodly sick, her brain felt like it was too big for her skull, her eyes felt like they were going to fall out, she had vomiting, diarrhea and a resting heart rate of 97 beats per minute which was around 30 beats per minute higher than her normal resting heart rate. She does normally check her heart rate and it's normally in the upper 60's beats per minute and lower 70's beats per minute. She also had chest pain and that prompted her to check her heart rate. Even though it was 97 beats per minute she knows that was normal range but it's high for her. She has had x-rays, CAT scans and her doctor's haven't found anything. She felt fine up until her dentist appointment and felt fine until she received the Novocain. She was asking if this was related to the Covid 19 vaccine were these side effects to be expected, and how long will these symptoms last. She has gone to several doctor appointments since receiving the Covid 19 vaccine and no one can find anything. She has had dental x-rays and endodontist took 3D dental x-rays to check for nerve issues for facial pain and swelling and she had a facial scan and had seen an Ear, Nose, and Throat doctor. The only thing anyone can suggest was that she grinds her teeth so she got a mouth guard. On an unspecified date, she had some severe pain in the right side of her face the other day so she put ice on it. She has taken Aleve, Tylenol, and Ibuprofen and the pain doesn't stop. It took hours, sometimes 4 hours before her face will start feeling better. But the pain has been consistent the last few days. The right side of her face has stayed swollen and sore. She clarified she was having right side facial pain and right-side facial swelling. She stopped going to the doctor because the doctor's aren't finding anything. She never knows when her face will start hurting, her face was still swollen today, 14Jul2021, and a little sore but it's not excruciating like it has been. On an unspecified date, her right eye was sore, and her right temple was sore. She can feel that her right face was swollen. She reported she had the first filling in a small cavity at the dentist on 26Apr2021. Later that night, she woke up and her mouth hurt horribly. She had to go back to the dentist on 28Apr2021 for another cavity filling on the other side of her mouth and she mentioned to the dentist that she had felt when the Novocain wore off with the small filling and the dentist told her that she shouldn't have felt anything because the cavity was so small. That Friday, 30Apr2021, she woke up in the middle of the night again with horrible pain and she thought this was weird. On Sunday, 02May2021 she had laid down to take a nap and woke up again in pain. On 03May2021, her dentist had her come back in and took dental x-rays again and he did not see what could be causing her pain. He thought maybe the pain could be related to a nerve issue. She was able to get an appointment with an endodontist the next morning, 04May2021 and had the 3D dental x-rays and the endodontist said it didn't look like she needed any root canal, and the nerves looked okay. The endodontist told her she grinds her teeth so he suggested a mouth guard. He suggested she try an over the counter mouth guard first. She got the mouth guard and a couple days later she was still having an issue waking up in pain. She called her primary care doctor and saw him on 20May2021. Her primary care doctor sent her for a CT scan on 26May2021. She doesn't think it was of her whole head but she's not sure. She thinks it was just a CT scan of the right side of her face and head. On 09Jun2021, she saw an Ear, Nose and Throat doctor and he told her she had a slight deviated septum but most people have a slight deviated septum. That doctor told her that he didn't find anything in her ears, nose, or throat that would be causing her issue. So, she's just been living with it, not ever knowing when her pain will come back. The pain used to just occur at night but the pain was starting to bother her during the day and her face was staying swollen. The Ibuprofen, the Aleve, and nothing was taking the pain away. She suggested that maybe there's an interaction with the Covid 19 vaccine and her being deathly sick after getting the vaccine that created this issue. She had seen different doctors and cannot tell if the vaccine has something to do with it. Her primary care doctor also gave her a prescription of Amitriptyline HCl 25 mg to take every night at bedtime as needed. She can't take it because it makes her completely sleepy the whole next day. She'll wake up in the morning and by 8:30AM-9:00AM she wants to take a nap. She tried taking half a tablet but it still makes her sleepy. She guesses she just can't take that medicine. The medications she has tried that aren't taking the pain away were as follows: acetaminophen 500mg, naproxen sodium 220mg, Orajel didn't work either and ibuprofen 200mg. She had put the Ibuprofen up because her husband was on so many medications and he can't take certain medications for pain so she puts her medications out of reach because her husband had a stroke and can't remember what medicine he can take and what he can't take. She started the other day taking Aspirin 81mg thinking maybe that will help if she takes a low dose Aspirin 81mg every day, no help yet. She was also prescribed Levofloxacin 500mg on 23Apr2021 for 10 days. She reported she did have a regular medical checkup with annual blood work on the Monday after the second Covid 19 vaccine. There were no additional vaccines administered on the same day of the covid19 vaccine and no prior vaccinations (within 4 weeks). Outcome of events vomiting, diarrhea recovered on an unspecified date; second dose: severe pain in the right side of her face, right side of her face has stayed swollen and sore, right eye is sore, her right temple is sore, second dose: mouth hurt horribly/still having an issue waking up in pain, woke up in the middle of the night again with horrible pain was not recovered; and outcome of the rest of events was unknown.
55 2021-07-28 flushing This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and allergy to walnuts and melon. Concomitant medications included insulin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN); all on unknown dates for unspecified indications. The patient previously took miconazole nitrate (MONISTAT) and fluconazole (DIFLUCAN); both on unknown dates for unspecified indications and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 16:00, the patient experienced throat felt irritated, blood pressure increased and face and neck became flushed. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of throat felt irritated, blood pressure increased and face and neck became flushed and included treatment with BENADRYL. The clinical outcome of the events throat felt irritated, blood pressure increased and face and neck became flushed was recovered on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-07-29 weakness feels bad; felt body aches; stuff and real weak; feeling sick in her stomach; chills; low-grade feve... Read more
feels bad; felt body aches; stuff and real weak; feeling sick in her stomach; chills; low-grade fever; light headache/headache; Out of breath just a little; I am sick; difficult for her to breathe; This is a spontaneous report from a Pfizer sponsored program. This is a contactable consumer or other non hcp reported for herself. A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6202) via an unspecified route of administration on 27Feb2021 (Age at Vaccination 55years old) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Bronchitis asthmatic, hypersensitivity from an unknown date and unknown if ongoing Verbatim: Allergy. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); montelukast sodium (SINGULAIR); ibuprofen (MOTRIN [IBUPROFEN]); paracetamol (TYLENOL) all taken for an unspecified indication, start and stop date were not reported. In Feb2021 the patient experienced difficult for her to breathe, out of breath just a little, i am sick, on 27Feb2021 light headache/headache, on 28Feb2021 feeling sick in her stomach, chills, low-grade fever, felt body aches, stuff and real week, on 01Mar2021 feels bad. Clinical course reported as she was just wondering, she wants to make sure about taking the second vaccine. she just got her first one on Saturday of this week. She is having a reaction to it, it's not bad, she is sick really bad with a headache and sick on my stomach. Yesterday I was running low grade fever and just felt body aches and stuff and real week. When paraphrased the concern, patient stated, Yes, if I should because yesterday my breath (Incomplete sentence), because I have asthmatic bronchitis and I didn't get really bad about it, out of breath just a little yesterday not real bad. When confirmed if the vaccine is Pfizer's Covid 19 vaccine, consumer stated, "Yes ma'am I am teacher since then we haven't been going out since Saturday morning. Treatment: she started the Motrin and Tylenol; she has been taking back and forth. she started this Saturday like before her even got the shot, she had already started it. The patient under-went lab tests and procedures which included body temperature: low grade fever on 28Feb2021 Low grade fever. The clinical outcome of the event low-grade fever was recovered, another events light headache/headache, feels bad was not recovered other events was unknown. No follow-up attempts are possible. No further information is expected.
55 2021-07-29 burning sensation Burning feeling on upper arms and face; Nausea; Vomiting; Chills; Exhaustion; itchy on upper arms an... Read more
Burning feeling on upper arms and face; Nausea; Vomiting; Chills; Exhaustion; itchy on upper arms and face; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 04May2021 at 08:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04May2021 at 09:15, the patient experienced nausea, vomiting, chills, itchy/burning feeling on upper arms and face, exhaustion. The clinical outcomes of nausea, vomiting, chills, itchy/burning feeling on upper arms and face, exhaustion were recovering. No follow-up attempts are needed. No further information is expected.
55 2021-07-29 pain in extremity soreness at the injection site; itchiness at the injection site; scabbing at the injection site; Ach... Read more
soreness at the injection site; itchiness at the injection site; scabbing at the injection site; Aching of left arm; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown,) via an unspecified route of administration, in the left arm on 31Mar2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included diastolic heart failure. The patient previously received PERCODAN, morphine (MANUFRATURER UNKNOWN) and GEODAN on unknown date and for unspecified indication. Concomitant medications included pramipexole (MANUFRATURER UNKNOWN), carvedilol (MANUFRATURER UNKNOWN), topiramate (TOPAMAX) and erenumab (AIMOVIG) all from unknown date and for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the right arm on 03Mar2021 at 15:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01Apr2021, the patient experienced soreness, itchiness, and scabbing at the injection site, aching of left arm which was persisting over a month. The clinical outcome of the events soreness, itchiness, and scabbing at the injection site, aching of left arm were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
55 2021-07-29 tingling, burning sensation tingling, prickling bottom of right foot; progressed to intermittent paraesthesia/ prickling come an... Read more
tingling, prickling bottom of right foot; progressed to intermittent paraesthesia/ prickling come and goes; burning sensations in limbs; tightening like a band around right calf, upper left arm, various nerve type issues like this; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161), via unspecified route of administration in the left arm on 10Apr2021 at 14:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had a history of allergy to sulfa drugs. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 09:00, 18 hours after the vaccination the patient experienced tingling, prickling bottom of right foot, progressed to intermittent parasthesias, burning sensations in limbs, tightening like a band around right calf, upper left arm, various nerve type issues like this and prickling that comes and goes. The clinical outcome of the event tingling, prickling bottom of right foot, progressed to intermittent parasthesias, burning sensations in limbs, tightening like a band around right calf, upper left arm and various nerve type issues was recovering at the time of report. No follow-up attempts are needed. No further information is expected.
56 2020-12-31 pain in extremity Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then m... Read more
Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then mild headache for 24 hrs. No symptoms after 24 hrs except sore arm for 2 days.
56 2021-01-03 weakness Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. ... Read more
Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. On day 2, patient experienced shills, diarrhea, headache, weakness that lasted 3.5 days. Reports follow-up with primary physician.
56 2021-01-03 facial pain After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was... Read more
After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was not to bad and I tought is a normal symptom but the pain and swelling an my face is increasing every day, even my teeth hurts and I'm taking Gabapentin 100MG 3 times a day. I am not sure if the vaccine components triggered my Trigeminal Neuralgia and if it's okay to get the second dose, I will see my Dr. tomorrow 01/05/21
56 2021-01-03 pain in extremity Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appe... Read more
Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appetite I had a hard time sleeping. I just took Tylenol.
56 2021-01-03 tingling Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling ,... Read more
Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling , headache
56 2021-01-04 weakness Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am and abou... Read more
Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am and about 3 minutes later, experienced nausea, dizziness and weakness. Patient was brought to ED to be evaluated @ 07:35 am. Ondansetron 4mg inj was given at 8:29am and NS 1000 mL was given over 2 hrs at 8:30am. Patient felt better and tolerating oral at 09:19 am and discharged at 9:25am.
56 2021-01-04 flushing About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I... Read more
About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I was taken to the ED where I was given non drowsy antihistamine and observed. At home I experienced severe fatigue, muscle aches and chills. At about 30 hours the symptoms went away
56 2021-01-04 pain in extremity soreness in arm when using arm or to touch; This is a spontaneous report from a contactable nurse. ... Read more
soreness in arm when using arm or to touch; This is a spontaneous report from a contactable nurse. A 56-year-old female nurse received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 28Dec2020 at 12:30 PM at single dose for COVID-19 immunization on right arm.Relevant medical history included ongoing osteoarthritis and high cholesterol. Concomitant medications included atorvastatin calcium (LIPITOR ORIFARM), escitalopram oxalate (LEXAPRO) and pantoprazole. On 28Dec2020 at 07:00 PM patient started experiencing soreness in arm when using arm or to touch. At the time of the reporting the patient was recovering from the event.
56 2021-01-04 pain in extremity Sore left arm 2-3 days after vaccinated; This is a spontaneous report from a contactable consumer. A... Read more
Sore left arm 2-3 days after vaccinated; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK5730, via an unspecified route of administration, in the left arm, from 22Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included allergies to penicillin, gluten, chicken eggs (whites & yolks) and cow's milk. Patient was not pregnant. The patient's concomitant medications were not reported. on 23Dec2020 09:00, after being vaccinated, the patient experienced sore left arm for 2-3 days. The patient underwent lab tests and procedure on unspecified date which included Nasal Swab test/COVID test, yielding negative result. The outcome of event was recovered on Dec2020. Follow-up attempts are completed. Information on the batch/lot number has been obtained.
56 2021-01-04 tingling, numbness Patient stated after vaccination felt lightheaded and numbness on left side. She sat down and had he... Read more
Patient stated after vaccination felt lightheaded and numbness on left side. She sat down and had her blood pressure taken. It was 171/105. Stated that she had not taken her morning blood pressure medications (lisinopril 10mg and atenolol 50mg). The nurse at the facility gave her a dose of lisinopril 10mg. Patient then stated prickly, numb feeling and foggy-headed. The facility then gave her 2 doses of diphenhydramine 25mg. At approximately 11am, patient was still not improving and felt like she was getting worse. The facility then called for an ambulance to take her to the ER for assessment.
56 2021-01-05 facial paralysis Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left ... Read more
Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left upper lip 2-3 hours after vaccine, but noted facial droop 3 days later. Numbness is improving at this time. Some fatigue.
56 2021-01-05 feeling cold "Received vaccine around 9:30am without any initial reaction. Around 9:30pm developed rigors felt co... Read more
"Received vaccine around 9:30am without any initial reaction. Around 9:30pm developed rigors felt cold no fever went to bed and rigors subsided after 20 minutes. Body did ache overnight and headache developed. Took Tylenol with some relief. In am aches and rigors remained absent but still had dull headache. Took headache medicine and otherwise felt fine. I have a history of feeling like this in the past after receiving my flu shot."
56 2021-01-05 pain in extremity Extreme pain in Right shoulder approximately 4 hours post injection and later difficulty lifting Rig... Read more
Extreme pain in Right shoulder approximately 4 hours post injection and later difficulty lifting Right arm. Shoulder pain moved into and included the axilla approximately 9 hours post vaccination. During the night, approximately 16 hours after vaccination, I began to have radiating, shooting pain up both sides of my neck up into the ears. This neck pain lasted approximately 72 hours. The arm pain had resolved at approximately 30 hours. The neck pain lessened and resolved with repeat applications of heat and Ibuprofen.
56 2021-01-06 weakness, numbness, pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
56 2021-01-06 weakness Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
56 2021-01-06 feeling hot, flushing Started feeling hot and flushed less than 24 hours after injection. No fever. Have been having 4-5 e... Read more
Started feeling hot and flushed less than 24 hours after injection. No fever. Have been having 4-5 episodes throughout the day since. No treatment needed. I just wanted to report just in case .
56 2021-01-06 feeling hot, hot flush In less than 24 hours following the immunization, feeling of "flush" and "warm inside" without fever... Read more
In less than 24 hours following the immunization, feeling of "flush" and "warm inside" without fever. Probably 6-8 times per day lasting greater than 30 min. This "warmth" or "flush" feeling continues to this day. I am peri-menopausal, but have not had "hot flashes" prior to the administration of the COVID immunization.
56 2021-01-06 feeling hot "Hot, Blotchy" given Benadryl 25mg liquid, po x1 dose. Resolved
56 2021-01-06 flushing Rash, itching, facial flushing/redness
56 2021-01-06 hot flush, tingling headaches, hot flashes, chills, rash on face, feeling like "mosquito bites" all over body
56 2021-01-06 pain in extremity C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest tw... Read more
C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest twinge". Radial pulse measured 88- pulse felt weak. Brought over to EMS for evaluation, monitor shows HR 87, BP 185/98 (160/88 manual), O2 99% on RA. HR came down to 79, BP 142/80. Around 0910 c/o nausea and dizziness. 0915 called daughter to drive her home, refused to transfer with EMT to hospital.
56 2021-01-06 pain in extremity Arm hurts and woke up with headache fever and body aches 12 hrs after vaccine was administered.
56 2021-01-06 pain in extremity Pain on injection site, turned red, swollen & hard.
56 2021-01-06 pain in extremity 2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; ... Read more
2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; 3-4 hours later took 3 ibuprofen due to the headache. Feeling light headedness. Next morning, sore arm was heavy, headache, body aches, temp 99, and nausea; felt unwell; took 3 ibuprofen. Time off from work to just lay flat and rest for the day.
56 2021-01-06 pain in extremity arm soreness from 12/31/20 to 1/5/21. fatigue 12/31/20 to 1/4/21.
56 2021-01-06 tingling, hot flush Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling "mosquito bites... Read more
Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling "mosquito bites" all over body
56 2021-01-06 tingling, hot flush Headache, chills, hot flashes, rash on face, feeling like "mosquito bites" all over the body
56 2021-01-06 throat numbness Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk ... Read more
Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk back to work area and started to feel numbness and tingling in tongue and throat, face as itching and cheeks red. Patient taking in observation room and emergency response team called for precaution. Patient remained alert. Team arrived taking taking blood pressure which was 185/108, Benadryl given, patient monitored. Team and patient agreed no emergency department care needed. Patient monitored for another 30 mins, blood pressure rechecked 158/95 . Patient allowed to return to unit. Had no signs of distress, denies shortness of breath or any throat discomfort. Patient was stable when leaving unit.
56 2021-01-07 weakness Patient received first dose of Pfizer COVID-19 vaccine on December 26. On the next day, December 27... Read more
Patient received first dose of Pfizer COVID-19 vaccine on December 26. On the next day, December 27, patient started having pressure in her head and sinuses, weakness. Then she developed nonproductive cough and progressive shortness of breath. She was seen at urgent care and tested positive for COVID-19 on December 29. She had low oxygen saturation on home oximeter and severe shortness of breath. Patient's husband is also ill with COVID-19 at home. Patient was sent to the ED and admitted to the hospital.
56 2021-01-07 feeling hot Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/... Read more
Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/P 126/86 HR 76 Sat 96% Patient did elect to call her husband to pick her up
56 2021-01-07 pain in extremity The next say I exp headache I was warranted cause on of my coworkers tested positive Covid. I went t... Read more
The next say I exp headache I was warranted cause on of my coworkers tested positive Covid. I went to ER high BP and got tested for Covid results negative. On that Saturday my BP was still high and left calf pain. Since I'm usually hypotensive I monitored my BP however it has continued to elevate.
56 2021-01-07 pain in extremity swollen uvula, throat lymph edema, arm soreness. has history of anaphylaxis
56 2021-01-07 pain in extremity Headache Fatigue, sore arm
56 2021-01-07 pain in extremity After the shot the next evening my arm was so sore and couldn't move my arm. After 8 days when I bec... Read more
After the shot the next evening my arm was so sore and couldn't move my arm. After 8 days when I became sick.
56 2021-01-07 tenderness Left shoulder pain and tenderness
56 2021-01-08 flushing Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later ... Read more
Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later Tylenol taken Next day painful injection site, body aches chills fatigue Tylenol Advil taken with some relief
56 2021-01-08 numbness Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, l... Read more
Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, left arm weakness/numbness, skin itching. BP checked and was 190/110, then 180/110. Hx HTN and BP meds taken today. Hx of allergies -- took loratadine and hydroxyzine this AM. Due to the dizziness and skin itching, feeling unwell/woozy with history of anaphylaxis, given epipen and called 911. EMS arrived and taken to ER.
56 2021-01-09 weakness, feeling hot Mild pain/soreness at injection site starting later the day of injection and next day. Approximately... Read more
Mild pain/soreness at injection site starting later the day of injection and next day. Approximately 2 pm the day after injection, began feeling overly hot and nauseated. That was followed by pressure type headache, muscle/bodyaches, and overall feeling of no energy progressing as the afternoon and evening continued. Spent that evening sleeping on/off. The following day spent in bed with continued headache, body/muscle aches, feeling overall drained/ no energy. Nausea improved some; was able to stomach some soup later in the day. So far today, feeling some improvement with bodyaches, but overall drained of energy. Headache has lightened some as well.
56 2021-01-09 pain in extremity, migraine 1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, ... Read more
1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, total body/muscle/joint aches, migraine headache, nausea, heart palpitations, as well as very sore, swollen arm. Had to spend the day in bed. Most symptoms relieved by the next 24 hours except arm pain and fatigue. 2nd vaccine: Similar, but worse symptoms developed approximately 12 hours after vaccine. All of the aforementioned symptoms, but fever of 101.4 and arm wasn't quite as sore. As above, had to spend a day in bed.
56 2021-01-09 tingling, pain in extremity Sore arm and tingling in fingers
56 2021-01-10 weakness Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports... Read more
Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports on 01/11/2021 to this RN that she had a couple nightmares after the first injection. Pt reports that she had two nightmares after the first dose. Since her second dose was received on January 8, 2021 she reports having disturbing night mares and requested reporting of the events. Pt declined evaluation at the clinic after notification of the event. Pt voiced she will follow-up with her PCP if the nightmares continue. Other side effects she reported with the second dose is nausea, tiredness, fatigue, headache, chills and some weakness. Those symptoms have since improved.
56 2021-01-10 weakness Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the P... Read more
Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the Pfizer vaccine (COVID-10) that she had had disturbing nightmares. Pt reports that she had two night-mares after the 1st dose, but said the second dose she started having nightmares this morning. Pt declined evaluation at the clinic after reporting of the events. Other S/S she had experienced are headache, nausea, chills, weakness, feeling tired but symptoms have improved.
56 2021-01-10 bell's palsy Numbing of tongue, possibly mild Bell's Palsy, and occurred about 7 minutes after vaccination
56 2021-01-10 feeling hot, pain in extremity 01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completel... Read more
01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completely and in the vaccination area it turned red and with a protuberance. 01/06/2021 when ingest food the chewing made difficult the chewing process I bit my cheek on the inside throughout the day. Itching in the right arm throughout the day. 01/07/2021 the tongue felt enlarged and I had to keep my mouth half open so it did not stick to the palate. 01/08/2021. On this day the arm had already improved the body warmth had decrease I was not tired and the tongue had decreased in size and heaviness. At no time was medications ingest other than propranolol which I must take daily under doctor's order.
56 2021-01-10 flushing feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta ... Read more
feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta at 5:36 patient reported to be feeling better - drank water - declined transport to ER - felt able/safe to drive home
56 2021-01-10 pain in extremity After 7hrs of the vaccine I was feeling very tired I had muscle ache almost a week later I went to t... Read more
After 7hrs of the vaccine I was feeling very tired I had muscle ache almost a week later I went to the ER because I had a lot of pain on my legs mainly on my right one I thought I had a blood clot but in the ER they told me it was just a reaction the the vaccine.
56 2021-01-10 pain in extremity 10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotic... Read more
10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotics and f/u w Allergy to determine whether to have second dose
56 2021-01-10 pain in extremity 3 hours post vaccine- severe nausea. Lasted for 29 hours 3 hours post vaccine. Left arm pain-mild, l... Read more
3 hours post vaccine- severe nausea. Lasted for 29 hours 3 hours post vaccine. Left arm pain-mild, less than flu shot pain. lasted 3 days. 6 hours post vaccine- bad headace-lasted 29 hours 8 hours post vaccine-mild chills. Lasted 5 minutes 10 hours post vaccine- another episode of chills-lasted 10 minutes 12 hours post vaccine-moderate tiredness. Lasted 24 hours 12 hours post vaccine-generalized achiness-lasted 24 hours
56 2021-01-10 pain in extremity Chills beginning Friday night into early Saturday morning. Low grade temperature on Saturday of 99 a... Read more
Chills beginning Friday night into early Saturday morning. Low grade temperature on Saturday of 99 at 10 am. Took Advil with relief. Sunday afternoon low grade temperature of 99 at 3 pm. Reports arm soreness bilateral.
56 2021-01-10 pain in extremity Fever, chills, arm ache, mouth ache, body aches, sore throat, dry cough, rash and exhaustion
56 2021-01-10 pain in extremity SEVERE LEFT ARM PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, GENERALIZED JOINT PAIN, FEVER, MALAISE AN... Read more
SEVERE LEFT ARM PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, GENERALIZED JOINT PAIN, FEVER, MALAISE AND FATIGUE STATED ON 1/9/2021, TOOK PERCOGESIC ALTERNATED WITH ACETAMINOPHEN
56 2021-01-10 pain in extremity STARTED WITH ACUTE LEFT ARM PAIN WITH DIFFULTY RAISING LIMB, PAIN EXTENDED TO LEFT SHOULDER AND ELBO... Read more
STARTED WITH ACUTE LEFT ARM PAIN WITH DIFFULTY RAISING LIMB, PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, FEVER, GENERALIZED JOINT PAIN, FATIGUE. TOOK PERCOGESIC AND ACETAMINOPHEN
56 2021-01-10 tenderness, tremor Shaking chills on 12/8/21 and low grade temp of 99.7 headache and body aches on 12/9/21 body aches a... Read more
Shaking chills on 12/8/21 and low grade temp of 99.7 headache and body aches on 12/9/21 body aches and fatigue on 12/10/21 local arm tenderness that started on 12/9/21
56 2021-01-11 facial paralysis, numbness, tingling Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight ... Read more
Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight down to the R jaw. Numbness, tingling feeling from R mid cheek moving toward R ear. Swelling of the face at this site as well. Paresthesia feeling, abnormal sensations at this same area of the face. These issues continues even to today. Initially, I experienced a H/A on the R sided above my eye which has not been occurring lately. On 1/8/21 I was seen by the NP at and was dx. with Bell?s Palsy. The NP noticed that when I initially speak my mouth doesn?t move properly, but once I get my words started then my mouth moves properly. My smile is noticed to be abnormal. The NP then sent me to ER for evaluation with the dx. Of Bell?s Palsy and because of another potential medical condition there?s a high risk for a stroke. A CT scan and blood work were obtained. A f/u script for a MRI of the brain has been ordered as well. Discharge paperwork states: Bell?s Palsy. Currently, I am taking a tapering dose of Prednisone and Valtrex as prescribed.
56 2021-01-11 numbness, tingling Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling wit... Read more
Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling within 10 hours after injection. 5 days after injection resulted in massive lower back pain and chills.
56 2021-01-11 migraine Patient said they experienced a migraine after being vaccinated and also reported they are prone to ... Read more
Patient said they experienced a migraine after being vaccinated and also reported they are prone to migraines
56 2021-01-11 muscle spasms Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tirednes... Read more
Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tiredness. Approximately 2.5hrs later developed generalized muscle aches, tired, chills. Next morning muscle aches were less, new headache and dizziness. took Tylenol which helped, about 5 hrs later symptoms worsened, improved with sleep and Tylenol. Awoke this morning with some chest pain similar to initial response, some headache and dizziness, improved with Tylenol, now returning (noon). occasionally feels like I need to take a deep breath. I believe its mostly muscular pain gets a little worse with deep breathing. Sent home from work day of vaccine, worked partial days next 2 days
56 2021-01-11 pain in extremity Sore Arm Can't lift arm
56 2021-01-11 pain in extremity Shivers. Chills. Body aches , fever 101.2 tympanic Sore left arm
56 2021-01-11 pain in extremity chills, elevated heart rate, headache, Sore Arm
56 2021-01-11 tingling, feeling hot I got extremely hot with sweating, I got a massive headache that started at the base of my neck tha... Read more
I got extremely hot with sweating, I got a massive headache that started at the base of my neck that effected my vision. I was dizzy, BP was high over 140, temperature increased. I had some tingling in my upper extremeties. I had really bad GI pains, I had itching and a light rash. I had to go to the ED where I received a cocktail.
56 2021-01-11 tingling, numbness Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hou... Read more
Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hours after injection. 5 days after injection; chills and major lower back pain.
56 2021-01-12 feeling cold Body aches, fever, chills, headache, nausea, sore throat, left ear pain, COVID exposure w/in 14 days
56 2021-01-12 feeling hot Stomach cramps, Itchy throat, neck itchy, and generalized warmth sensation without fever.
56 2021-01-12 pain in extremity, discomfort Had a sore arm about 6 hours after. Four days after vaccine - 4:30 am woke up with severe nasal drai... Read more
Had a sore arm about 6 hours after. Four days after vaccine - 4:30 am woke up with severe nasal drainage and pressure. Headache. Very congested. Medicated with Mucinex and Advil Sinus. A couple days later went to my chest. Got medical care from Telemed visit - Z-Pac - took for five days - 250 mg and a liquid decongestant: Guaifenesin - 100 mg/5 mm once every six hours for 10 days as needed. I took it for six or 7 days. Resolved.
56 2021-01-12 pain in extremity Arm was very sore. Lasted 2 days. On 24th Dec. woke up with very heavy nasal drainage; continued for... Read more
Arm was very sore. Lasted 2 days. On 24th Dec. woke up with very heavy nasal drainage; continued for several days and it went to my chest. I Medicated with: Mucinex and Advil sinus - but wasn't working. Telehealth call to DR. and He prescribed C-Pac - 250 mg - 5 day dose and decongestant: Guaifenesin 100 mg - 5 mg liquid - 10 ml every six hours by mouth as needed for 10 days and I took that decongestant for 6 days. Felt better at this point. Never had had this before.
56 2021-01-12 cold extremities, cold extremities 16 hrs post 2nd COVID vaccination injection I experienced the following symptoms: severe aches and p... Read more
16 hrs post 2nd COVID vaccination injection I experienced the following symptoms: severe aches and pains in joints, chills-cold hands,feet, lethargy, slight nausea, diarrhea. Symptoms subsided over the following 24 hours. Joint aches continue
56 2021-01-12 tension headache, pain in extremity Mild arm soreness started within 6 hrs of administration of vaccine. Within 12-16 hours of adminis... Read more
Mild arm soreness started within 6 hrs of administration of vaccine. Within 12-16 hours of administration patient developed intermittent chills, fever 101.4 to 102.2 F , moderate to severe tension headache, mild muscle ache/joint pain, insomnia, severe fatigue, and mild nauseau. Fever lasted for approximately 48 hours. Other signs and symptoms resolved by 72 hours following vaccination. Patient also noticed mild fatigue as well as slight disorientation and slight loss of balance until 1/11/21. Patient was normal by 1/12/21. No specific treatments administered.
56 2021-01-13 weakness approximately 20 hours after vaccine woke with generalized myalgia. Throughout the day began to fee... Read more
approximately 20 hours after vaccine woke with generalized myalgia. Throughout the day began to feel weaker and getting confused. C/O legs weighing 500 pounds and leg weakness with difficulty walking. Intermittent chills.
56 2021-01-13 flushing Had flushing and warm BP elevated to 158/98 pulse 68 for 30 min and resolved on own
56 2021-01-13 pain in extremity left arm/shoulder soreness; Left arm/shoulder soreness; headache; light headedness; fatigue; aches; ... Read more
left arm/shoulder soreness; Left arm/shoulder soreness; headache; light headedness; fatigue; aches; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 07Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, allergic to certain types of chocolates. Concomitant medication included Levothyroxine and vitamins. The patient was also allergic to Quinine, tramadol, Dilaudid, Msg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left arm/shoulder soreness, headache, light headedness, fatigue and aches on 07Jan2021 11:45 AM. The patient received Tylenol and bed rest as treatment. Events outcome was not recovered. Information about lot/batch number has been requested.
56 2021-01-13 pain in extremity Felt sore arm (deltoid), developed headache (20 hours after vaccine), body aches, chills (developed ... Read more
Felt sore arm (deltoid), developed headache (20 hours after vaccine), body aches, chills (developed 30 hours after vaccine). Temp 100.1, (approx 32 hours after vaccine). All resolved 43 hours after vaccine.
56 2021-01-13 pain in extremity itching/itching at the site and on her chest going all the way to her groin; rashes/She does have th... Read more
itching/itching at the site and on her chest going all the way to her groin; rashes/She does have the rash some already but she expects it to get worse. The rash starts at the armpits and goes down to the groin; itching at the site; soreness on her arm; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 56-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), by injection via an unspecified route of administration on Arm Left on 06Jan2021 12:00 noon at single dose for covid-19 immunisation (front line health care worker). Medical history included Hot flashes, Hashimoto's disease, Osteoporosis and Allergy. Concomitant medications included ongoing estrogens conjugated/medroxyprogesterone acetate (PREMPRO) at 0.45mg; take once daily by mouth for Hot flashes from 2017, ongoing Levothyroxine at 50mcg; take once daily by mouth for Hashimoto's disease from 2014, ongoing alendronate sodium (FOSAMAX) at 70mg; take once weekly by mouth for Osteoporosis from 2017, montelukast sodium (SINGULAIR) at 10mg; take once daily by mouth for allergy from 2018, ongoing Azelastine at one spray per nostril daily for Allergy from 2019, ongoing Fluticasone at 50mg; one spray each nostril daily for Allergy from 2019, ongoing Hydroxyzine at 10mg; once daily by mouth for Allergy from 2019. The patient had the COVID-19 vaccine yesterday (06Jan2021) and today (07Jan2021) 16:00 experienced itching and rashes. She also had soreness on her arm. She is concerned whether this is expected of the COVID-19 vaccine and will it happen again because she has heard that the side effects may worsen on the second dose of the vaccine. What would happen if I don't get the second dose of the vaccine? Itching was reported as worsened. Rash was reported as worsened. Occupational Therapist calling regarding the Pfizer COVID 19 vaccine. States she had the vaccine yesterday and just started itching and can't get up with her primary care provider. Asking if this is a normal side effect? Will it happen again? Reports she received the first dose of the COIVID 19 vaccine 06Jan2021 at 12:00 noon in the left arm. Today 07Jan2021 within the last the hour, 16:00, she started itching at the site and on her chest going all the way to her groin. Adds she has a lot of allergies and that is how it always starts. She knows she will wake up with a red bathing suit rash. She does have the rash some already but she expects it to get worse. The rash starts at the armpits and goes down to the groin. Reporter is Occupational Therapist reporting on herself She is unsure if she will take the second dose of the vaccine. Vaccination Facility Type was nursing home. No vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Physician Office or ER.Prior Vaccinations (within 4 weeks) was none. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was none. The outcome of the events Itching and rash was not recovered. The outcome of the other events was unknown.
56 2021-01-13 pain in extremity Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck ... Read more
Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck and arm
56 2021-01-13 tingling, weakness 56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine.... Read more
56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine. She reports feeling weakness and dizziness. She states she fellt sensation to her neck immediately after she got the vaccine. Pt appears very anxious. Provided cold pack behind her neck and vital signs taken 152/90 with HR 98 O2 SAT 98%. Pt then taken to the gurney to lay down. Pt continued to feel weak with short of breath, tingling finger tips. 100% NR mask provided, Dr notified and arrived immediately. vital signs taken every 5-10 min with b/p trending down within 20 minutes. Pt states felt better around 1150. Attempted to sit up but states felt weak again. Pt felt anxious and wanted to speak to her husband, Medic, called husband and was able to speak to him. Pt continues to feel weak. Continue to monitor and comfort provided. Discussed with medical team that patient need to be sent to the ER for further observation. 911 called at 1215 and arrived within few minutes, report given to EMS. Patient transferred to ER at 1230 via gurney. 1117: 152/90,HR 103, O2 sat 98% 1121: 144/72, HR 89, O2 SAT 99%-applied O2 100% non rebreather mask 1126: 153/88, HR 80 1142: 160/92, HR 85, O2 SAT 100% 1147: 147/85, HR 77, O2 SAT 100% 1152: 136/85, HR 70, 02 SAT 100% 1202: 133/81, HR 68, 02 SAT 99%
56 2021-01-13 tremor The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling ... Read more
The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling like her heart was racing and short of breath. She was diaphoretic, had a notable tremor and reported anxiety as well. Patient was transported to the Emergency Department where the patient was monitored. Ultimately, patient felt better, with a normal EKG. Patients states this reaction felt similar to anxiety attacks she has had in the past. ED Physician felt this was likely an anxiety attack. Patient remained stable throughout ED course and was discharged from the ED in stable condition.
56 2021-01-14 pain in extremity, mild one side paralysis, numbness Left leg pain, increasing in intensity over 2 1/2 weeks requiring treatment. Sharp pain down leg, w... Read more
Left leg pain, increasing in intensity over 2 1/2 weeks requiring treatment. Sharp pain down leg, with an achiness in bones of entire leg, numbness in toes at times, with increasing weakness. Received Doppler scan, X-rays, and MRI with no know problems seen. Required treatment of prednisone, anti-inflammatory meds, Percocet, gabapentin, as well as epidural.
56 2021-01-14 pain in extremity Fever chills fatigue arm pain upset stomach bradycardia
56 2021-01-14 tingling, bell's palsy, facial paralysis, tremor Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left... Read more
Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left side of face. On exam, she had left facial droop consistent with Bell's palsy. She was monitored for about an hour with no further progress, and some visible improvement. She had tremor of right hand. By next day, patient reported complete resolution of symptoms. Of note, patient has multiple sclerosis and will have similar symptoms when she has a flare. Jen Silvey spoke with patient on 1/6/2021 @ 2051: "Her face - no droop to left side of her face and lips- back to normal. But her tongue is still tingling."
56 2021-01-14 tremor Mental confusion,shakes, foggy brain , things did not make sense to me, driving confusion
56 2021-01-16 pain in extremity I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lighthead... Read more
I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lightheadedness and nausea upon awakening Saturday morning. Saturday night was having increased nausea and lightheadedness. Got up to use the bathroom at 1 AM Sunday morning was very dizzy and nauseous and passed out on my hallway floor. I woke choking on vomit, crawled to the bathroom, continued to vomit. Sustained bruised lump to forehead, bruised nose, split lips. Went back to bed. Later Sunday felt better.
56 2021-01-17 weakness, unresponsive to stimuli Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the ob... Read more
Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the observation area. Her husband and I walked her over to the cot and medical treatment area. Her pulse felt thready and weak while walking and her gait was unsteady. As soon as she sat, then lay on the cot she lost consciousness and did not respond to verbal or noxious stimuli over the next few minutes. I gave her one dose of an epi-pen into her left mid outer thigh but she still did not regain consciousness so we called a "Rapid Response code" for transport to the E.R. for further treatment and stabilization.
56 2021-01-17 weakness Dizziness; Weakness; Tiredness; This is a spontaneous report from a contactable consumer who reporte... Read more
Dizziness; Weakness; Tiredness; This is a spontaneous report from a contactable consumer who reported for herself, a 56-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Dec2020 at a single dose with lot number: EJ1685, and the second dose via an unspecified route of administration on 10Jan2021 at a single dose with lot number: EL3248, for COVID-19 immunization. The patient had no medical history nor concomitant medications. When patient had the first vaccine on 20Dec2020, she experienced dizziness, weakness and tiredness which lasted for 4 days. The outcome of the events was recovered with sequelae, patient received the second dose of the Covid-19 vaccine on 10Jan2021, she was also having dizziness, weakness and tiredness which were ongoing at the time of report.
56 2021-01-17 difficulty speaking I sat for 15 minutes and felt fine but when I was leaving I had to climb up a set of stairs, after d... Read more
I sat for 15 minutes and felt fine but when I was leaving I had to climb up a set of stairs, after doing that I felt light headed and out of breath. That continued for about 15-20 minutes. At 30 minutes after the injection my voice went hoarse. About an hour after I had a serve bullet like headache in one point in my head, I took Tylenol and lasted for about 5 hours. I started taking Benadryl (25mg), the headed improved, but when I woke up in the morning the next day I had all over swelling to the the point where I couldn't make a fist and had facial swelling . The facial swelling lasted for 5 days. My co worker took my vitals signs but everything was normal. For the next 5 days I had facial swelling that increased, hands got better. I continued to Benadryl . After the 5th day things finally started to get better. I did go back to have my second dose. I contacted my PCP but he was out of town .
56 2021-01-17 tremor Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the follow... Read more
Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the following day. The first symptoms were ear and sinus pressure. Then malaise/fatigue, headache, mild stomach upset. Fever occurred in the middle of the night and got up to 101.1. Also developed shakes/tremors and severe back and body aches. My arm was sore at site of injection.
56 2021-01-18 weakness, feeling of body temperature change Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side ... Read more
Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side from neck, down back into hip and leg in severe pain(muscles tense); entire left side from neck, down back into hip and leg in severe pain(muscles tense); felt ill; felt extreme weakness; sneezed about 20-25 times; eyes turned red; The spinning and unable to focus continued for about 6 hours; The spinning and unable to focus continued for about 6 hours; Headache was coming and going; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EH9899) via an unspecified route of administration at left arm on 31Dec2020 at 08:30 AM at a single dose for COVID-19 immunization. Medical history included known allergies (allergies to medications, food, or other products), and no other medical history. The patient was not pregnant. Concomitant medications the patient received within 2 weeks of vaccination included vitamins/supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at facility. 10 minutes after the patient felt a little lightheaded/dizzy. At 20 minutes after her entire left side from neck, down back into hip and leg in severe pain (muscles tense), at 30 minutes she sneezed about 20-25 times, felt extreme weakness and her eyes turned red. She felt ill. The spinning and unable to focus continued for about 6 hours. Headache was coming and going. She felt hot and cold on and off. All events with start date on 31Dec2020 at 08:45 AM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
56 2021-01-18 weakness 1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes ma... Read more
1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes mark which subsequently resolved spontaneously at 30 mins (closely monitored by MD, NP) 2nd vaccine: spontaneous tachycardia, and elevated BP (160/100) at 10 minutes mark (monitored by MD and NP), normalized after 1 hour of observation. On 1/8/2020 I developed severe fatigue, fever, numbness on lower lip, bitter taste in my mouth, fever, chills, headache until Sunday 1/10/2021. Went to work on 1/11/2021 with worsening symptoms. Ended up in ER on 1/12/2021 due to weakness, high BP, numbness on lower lip, difficulty focusing. BP is normalizing as of 1/19/2021 but still have weakness, equilibrium is off and difficulty in focusing
56 2021-01-18 migraine Dose1 start time 28Dec2020, dose 2 start time 11Jan2021; Red, inflamed, hot to touch injection site;... Read more
Dose1 start time 28Dec2020, dose 2 start time 11Jan2021; Red, inflamed, hot to touch injection site; Red, inflamed, hot to touch injection site; Red, inflamed, hot to touch injection site; Chills; fever- 99.8; severe headache (migraine); This is a spontaneous report from a contactable nurse (patient) reported for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand=Pfizer, lot number=Ek9231) intramuscularly at left arm on 11Jan2021 at 01:30 PM at a single dose (dose number:2) for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM) and known allergies to latex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included metformin, atorvastatin, lisinopril, exenatide (BYDUREON) and bimatoprost (LUMIGAN). Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand=Pfizer, lot number= Ek5730) intramuscularly at left arm on 28Dec2020 at 02:30 PM at a single dose (dose number:1) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included "red, inflamed, hot to touch injection site", chills, fever- 99.8, and severe headache (migraine); all with start dates on 11Jan2021 at 08:00 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
56 2021-01-18 night sweats, feeling hot, feeling cold 10 minutes after the time of the injection I developed metal taste in mouth this lasted about 1 hour... Read more
10 minutes after the time of the injection I developed metal taste in mouth this lasted about 1 hour went away and came back later in the day. 13 hours after the vaccine injection I developed extreme rigors lasting atleast 60 minutes followed by very hot body temperature to touch unable to sleep body not comfortable cold then hot and very bad headache. Next day rested all day terrible headache, body aches and chills on and off. The next night did sleep for 5 hours then woke up soaked hair night garments had to change still had headache and just felt achy and tired all day mild headache arm was sore warm at inj site and very itchy. Third day headache was gone just felt extreme fatigue and today tired but feel more like myself.
56 2021-01-18 pain in extremity Patient describes Arm soreness, repiritory (congestion) Fever and chills.
56 2021-01-18 pain in extremity sore arm chest pains began on friday December 25th
56 2021-01-18 tingling Received vaccine at 10:30am, completed 15 minute post monitoring without adverse event. Upon driving... Read more
Received vaccine at 10:30am, completed 15 minute post monitoring without adverse event. Upon driving home within 5 minutes of leaving started feeling tingling in face and nose. Felt roof of mouth tingling and tongue and eyes felt swollen and felt flushed. Face was notably red. EMS assessed patient established IV. 0.3mg epinephrine given IM and 50 mg Benadryl administered IVP. Patient agreed to go to ED and transported by EMS without issue. Vital signs remained stable and wnl throughout reaction monitoring.
56 2021-01-18 tingling tingling tip of tongue and upper extremities
56 2021-01-18 tenderness Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and ten... Read more
Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and tender to the touch. Notified primary care physician during routine visit, PCP advised to notify her if symptoms did not resolve. Swelling resolved 4 days after onset, arm remained somewhat sensitive to the touch. Patient was also extremely tired for 2 days after the vaccine but otherwise fine.
56 2021-01-19 weakness At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling naus... Read more
At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling nauseated almost threw up, also felt drunk (balance, lack of clear thinking, a little weak, etc). That lasted from about 8 hours after the shot (when it started) to 20 hours after the shot was administered.
56 2021-01-19 facial paralysis, numbness Patient developed right facial numbness and facial droop on 1/7/21. She came to the TMH ED and was a... Read more
Patient developed right facial numbness and facial droop on 1/7/21. She came to the TMH ED and was admitted. She was afebrile; neurologic exam was consistent with a peripheral facial palsy on the right.
56 2021-01-19 numbness Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination.... Read more
Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination. Patient said she felt like she couldn't breathe. Taken to ED for further evaluation.
56 2021-01-19 pain in extremity, tremor acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7... Read more
acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7 minutes then stopped - 30 minutes after injection given blurry vision - 30 minutes after injection given mild shaking - following morning lasting for about 2 hours extreme fatigue - lasting for 48 hours - Sunday evening through Tuesday evening
56 2021-01-19 pain in extremity sore arm, gastric upset, tirednessn/a
56 2021-01-19 pain in extremity From the evening of the day I have received the vaccination, my left arm started to feel dull contin... Read more
From the evening of the day I have received the vaccination, my left arm started to feel dull continuous pressure pain, progressed stronger and stronger as the time goes. No treatment given. Following day, the pain was worse and stayed same. The IM insertion site was also painful to touch or pressure. Then afternoon of the same day, I started nausea, light headache, dizziness, and occasionally chills as well as occasional dry cough accompanied by itchy throat or without itchy throat. At this point, I took Advil 200mg 1 tab around 3pm. The muscle pain on my left arm and headache is eased but other symptoms stayed same at this time, 4:30pm.
56 2021-01-19 tingling Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", ... Read more
Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", tingling in legs. Patient was monitored for approximate one hour total in the clinic. Patient vital signs were stable at the beginning and continued to be stable. No other signs or symptoms of an allergic reaction.
56 2021-01-19 tingling had itching and tingling the next day. with in 2 days hives all over chest and arms.
56 2021-01-19 tingling Patient reports tingling in hands, nausea, and sweating with the first dose.
56 2021-01-19 tingling PATIENT REPORTS TINGLING IN HANDS, NAUSEA, AND SWEATING WITH THE FIRST DOSE
56 2021-01-20 flushing Site: Redness at Injection Site-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Fainting-Mil... Read more
Site: Redness at Injection Site-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Fainting-Mild, Systemic: Patient felt faint then had an overall body flushing sensation, quickly went away shortly after vaccination-Mild
56 2021-01-20 muscle spasms Hives Charlie horse in right leg, front calf
56 2021-01-20 pain in extremity, numbness On the day of vaccination (1/6/2021), I had arm pain and chills which continued into the next day. I... Read more
On the day of vaccination (1/6/2021), I had arm pain and chills which continued into the next day. I felt fine on 1/8/2021. On 1/13/2021 I began to have arm pain and shoulder weakness. The arm pain has resolved but I have transient numbness and the shoulder weakness is getting more and more painful.
56 2021-01-20 pain in extremity Body ache; Headache; Light fever; Sore arm; neck pain; It's swollen under my right arm; This is a sp... Read more
Body ache; Headache; Light fever; Sore arm; neck pain; It's swollen under my right arm; This is a spontaneous report from a contactable (patient). A 56-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm, on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included hydrochlorothiazide for hypertension. Patient reported that on Friday (Jan2021), she took her first dose of vaccine. She didn't have any reaction right away but after like 8 to 9 hours in Jan2021 she had body ache and headache, light fever. She knew this sore arm would be, it always will be there, she knew it's now under her arm, it's swollen under her right arm that she took the vaccine, was swollen. Patient took ibuprofen (MOTRIN, Expiry Date: Jun2023) 200 mg orally two times a day for treatment. Her body does not as hurt as it used to after taking it, but she still has neck pain and her arms still hurting and right now under her right arm that she took the shot that was swollen, patient said she still has 'this band' (not clarified further) in her neck right now. Patient works in the healthcare. She does cut skin. She took it at her work. Patient did blood test three months ago (Oct2020) at her doctor's office. Outcome of sore arm was not recovered, outcome of body ache was recovering, outcome of other events was unknown. Information on lot number/batch number was requested.
56 2021-01-20 pain in extremity chills, sore arm, heart racing loss of appetite
56 2021-01-20 pain in extremity moderate tiredness; generalized achiness; mild chills/another episode of chills; Bad headache; sever... Read more
moderate tiredness; generalized achiness; mild chills/another episode of chills; Bad headache; severe nausea; Left arm pain-mild, less than flu shot pain; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received bnt162b2 (COVID 19, Pfizer, lot number: EL3246), via an unspecified route of administration on the left arm on 08Jan2021 16:45 at a single dose for an COVID-19 immunisation. Medical history included impaired gastroparesis, pancreatitis, hashimoto's thyroiditis, allergies: sulfa and adhesives. The patient's concomitant medications were not reported. The patient has known allergies with pethidine hydrochloride (DEMEROL). The patient is not pregnant. The patient has no COVID prior vaccination and was not COVID tested post vaccination. On 08Jan2021 at 19:45 (3 hours post vaccine), the patient experienced severe nausea that lasted for 29 hours; and left arm pain-mild, less than flu shot pain that lasted 3 days. At 22:45 (6 hours post vaccine), the patient had a bad headache that lasted 29 hours. On 09Jan2021 at 00:45 (8 hours post vaccine), the patient experienced mild chills that lasted 5 minutes, then 02:45 (10 hours post vaccine) another episode of chills that lasted 10 minutes. On 09Jan2021 at 04:45 (12 hours post vaccine), the patient experienced moderate tiredness and generalized achiness that lasted 24 hours. The patient recovered from severe nausea on 10Jan2021 00:45 and bad headache on 10Jan2021 03:45, recovered from left arm pain-mild, less than flu shot pain on 11Jan2021, recovered from chills on 09Jan2021 00:50, and recovered from moderate tiredness and generalized achiness on 10Jan2021 04:45.
56 2021-01-20 tremor 3 hours post innoculation, sore throat with swollen glands, chills, shaking and a mild headache. S... Read more
3 hours post innoculation, sore throat with swollen glands, chills, shaking and a mild headache. Shortly thereafter, started experiencing uncontrolled itching and my skin was bright red (flushed) from above pubic bone and up to top of my head. (nothing on lower extremities). No fever (98.1) and no visible rash. The itching became so uncontrollable, I took 25mg Benadryl and remained taking it every 4 hours until 1/21/21. A very fine, red rash appeared on 1/20/21 in the early morning. The rash was, mainly at my fatty areas, breasts, abdomen and hips, but the Benadryl helped to control the itching. The Benadryl did not take away the itching entirely. As of this morning, the rash has faded, but i'm still itching, mildly, in my abdomen and out edges of my breasts. I am going to try to stop the Benadryl this morning and see how I do. If not better, will go see my PCP.
56 2021-01-21 flushing Flushing, dizziness, throat tightening, difficulty swallowing
56 2021-01-21 numbness Systemic: numb from the neck up
56 2021-01-21 tremor Chills, couldn?t get warm! Whole body couldn?t stop shaking, Pounding headache, Fever, & Vomiting.
56 2021-01-22 flushing At the clinic today had who suffered an adverse reaction. When she came in for the vaccine she was e... Read more
At the clinic today had who suffered an adverse reaction. When she came in for the vaccine she was extremely nervous due to a hatred for needles. She got the vaccine and within 5 minutes she turned red and her blood pressure sky rocketed to 203/104. She had no difficulty breathing, no rash, just flushed skin and high blood pressure. Her pulse was also elevated to 103. Due to, the ambulance was called. She expressed her wish to not go to the hospital multiple times due to being afraid of missing work and hating the hospitals. By the time the ambulance came her blood pressure was 203/104 with a pulse of 104. Her pulse ox remained at 98 on room air. From the minute she felt ill to the minute they left made sure she was breathing ok and showed no signs of anaphylactic shock. She had a history of panic attacks and GERD, with no blood pressure problems. She did also report an allergy to latex and penicillin prior to the vaccination. All products again were double checked to show her they were latex free. Patients blood pressure decreased at the hospital and was discharged with directions to follow up with her primary. They stated they aren't sure why her blood pressure increased so high.
56 2021-01-24 discomfort Muscular pain and discomfort went to the doctor
56 2021-01-24 facial pain face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on ... Read more
face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on 1/22/21 and then my eyes were swollen, bruised and painful upon waking 1/23/21 and lasted until early morning of 1/25/21. My whole face was sore to touch during this time. I also had fatigue and headache starting 1/21/21 which lasted a few days along with fever, chills, body aches and sore left armpit which started early morning 1/22/21. I had expected these last symptoms so was not alarmed. I was not warned about the facial swelling and that was a bit scary.
56 2021-01-24 flushing, hot flush, pain in extremity, tremor, tenderness, tingling significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness;... Read more
significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness; muscle weakness/lower leg feel shaky and weak and tingly; depersonalization; shakey/lower leg feel shaky and weak and tingly; mild nausea; arm pain; The caller would touch her hand but couldn't feel her hands, it was like they weren't hers; lower leg feel shaky and weak and tingly; hand on that same side was painful, but not unbearable, just uncomfortable; emotional; tearful; felt completely overwhelmed; This is a spontaneous report from a contactable consumer. A 56-Year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 12Jan2021 about 9:15am at single dose for COVID-19 immunization. Vaccination facility type was hospital. Medical history and concomitant drugs were not reported. Weight: 175-180 lbs. No additional vaccines administered on same date of the Pfizer suspect vaccine. No prior vaccinations within 4 weeks. Past drug included rivaroxaban (XARELTO) been using the product more than 10 years and never had a problem with it, she didn't think that was related to her experience. Patient received first vaccine yesterday 12Jan2021. 45 minutes after receiving vaccine (12Jan2021 10 AM), she developed hot flashes in sternum (flushing sensation in her sternum or upper chest area. It was like when she had a dye injected), anxiety, dizziness/ light headedness, muscle weakness, significant dissociation, depersonalization, shakey, mild nausea, arm pain. The patient explained that this was why she was in the MRI scanner (Jan2021). This came a couple of times yesterday and had not been experienced this today (13Jan2021). It (dizziness) was ongoing and sporadic and had happened couple times yesterday and today. There were a few hours yesterday 12Jan2021 where she felt like herself but then it all started again last night. The patient reported feeling disassociated from her body, this was within about 20 minutes of the flushing and went in and out of being more or less alarming. She stated she felt disconnecting from where she was and space she was in, mentally. She knew where she was but could feel no connection to where she was or her body. The patient would touch her hand but couldn't feel her hands, it was like they weren't hers. This was during the half hour of the events occurring. She had mild nausea, this started not long after the flushing and it came and went a little bit but it was not too troublesome. The patient felt disconnect from her body and had shakiness like her lower leg feel shaky and weak and tingly. This happened on and off since the episodes started. The patient reported she slept great and had a few hours yesterday where she felt good. Her arm was tender, this might have been yesterday but she thought it was this morning and was only tender to touch. The hand on that same side was painful, but not unbearable, just uncomfortable. The patient apologized for being emotional and tearful. She felt completely overwhelmed. She couldn't believe that she put herself in this position and she was perfectly fine before the shot. She did contact her doctor. No AE required a visit to emergency room/ physician office. There had been no treatment, she didn't know what to do. She remarked she was not going back for the second dose. Outcome of event dizziness was not recovered, and the rest of events was unknown.
56 2021-01-25 flushing The first covid vaccination I had symptoms of being flush and a heaviness in my chest. This lasted ... Read more
The first covid vaccination I had symptoms of being flush and a heaviness in my chest. This lasted 4 3-4 days. I did seek medical attention at the emergency room day 3 and was hospitalized 1 day. I was found to have unexplained and unregulated hypoglycemia. The second shot I had body aches, headache, fever. I was able to manage my symptoms with Tylenol and Advil.
56 2021-01-25 hot flush s/p 1st dose vaccine c/o feeling flushed with palpitations and dizziness
56 2021-01-25 pain in extremity Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all o... Read more
Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all over, can hardly move; This is a spontaneous report from a contactable consumer reported for self. This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via unspecified route of administration on 12Jan2021 between 13:30 and 14:00 at single dose in left arm for COVID-19 immunization. Patient worked in EVS. The patient medical history included rheumatoid, asthma, artery disease, gastroparesis. There is no family medical history. The patient concomitant mediations not provided. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 22Dec2020 at single dose in left arm for COVID-19 immunization. The patient had a headache with the first dose of bnt162b2 and a little bit of chest pain (stated she had heart troubles) (AER 2021050910). The patient experienced severe headache, nausea, and pain all over, can hardly move from 12Jan2021. Pain all over, can hardly move started at the night of 12Jan2021. It hurts so bad. The patient also experienced runny nose and left arm is hurting from unspecified date. There is no relevant tests. The outcome of events severe headache, nausea, and pain all over, can hardly move was not resolved. Nausea and pain all over, can hardly move was reported as worsened. The outcome of others event was not reported. Information about lot/batch number has been requested.
56 2021-01-26 numbness, feeling hot, pain in extremity Had a hot spot in my right palm that lasted 24-48 hours I think pretty soon after for sure on my ... Read more
Had a hot spot in my right palm that lasted 24-48 hours I think pretty soon after for sure on my drive home from work I noticed Right side of face felt funny then numb on cheek, whole side of right head top of scalp to jar and over to right ear x 8-10 days Sore arm, tiredness and fatigue x10 days and some numbness in hand x5 days
56 2021-01-27 weakness, flushing, pain in extremity metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chil... Read more
metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chills weakness, fatigue the next day aches, weakness and fatigue headache continued for 5 days fatigue and headache continues daily
56 2021-01-27 weakness Chills, joint pain overall felling tired and weak
56 2021-01-27 burning sensation Swollen, Large Red whelp with hard knot inside arm. Burning and itching sensation. Ibuprofen and i... Read more
Swollen, Large Red whelp with hard knot inside arm. Burning and itching sensation. Ibuprofen and ice packs did not improve area.
56 2021-01-27 feeling hot Warm feeling in back of throat that started about 10 minutes after the shot, then immediate dizzines... Read more
Warm feeling in back of throat that started about 10 minutes after the shot, then immediate dizziness and I went out for help from a physician in hallway. Next thing I remember I was on an exam table and I had not strength in my limbs and core. I had a rash on neck and chest. They monitored my vitals and decided I needed to go to urgent care or ER. Since the urgent care was on the way to the ER they took me there. They moved me from wheel chair to ecam table. Gave me epi and Benadryl injections, prednisone by mouth and started an IV. They monitored my vitals and said if I worsened are didn't respond then they would send me to ER. They gave me some Pepcid and eventually over the 3 hours I was able to stand on my own and they decided to discharge me around 14:00, making sure that I had someone who could stay with me at home.
56 2021-01-27 feeling hot Experienced warm feeling, nausea and itching of lips within 10 minutes of administration. After app... Read more
Experienced warm feeling, nausea and itching of lips within 10 minutes of administration. After approximately 40 minutes noted itching in throat. Returned to vaccination area approximately 60 minutes after injection for guidance and instructed to ED. Noticed lip swelling and facial swelling later in ED, had mask on entire duration, did not note when first occurred. Lip itching, throat itching relieved with Benadryl, prednisone and pepcid all given po, released to home after 4 hours observation. Throat itching persists on day 2, some relief with benadryl Q 4 hours.
56 2021-01-27 flushing started yawning 5 minutes, yawning multiple times a minute, could not even speak without yawning. S... Read more
started yawning 5 minutes, yawning multiple times a minute, could not even speak without yawning. Stopped yawning at 2pm then broke out in rash on trunk, neck, arms, face, flushed. Took 2 benadrdyl, monitored x 1 hr, rash subsiding, then started itching at 5pm all over, at 8pm left arm got blood red, throbbed x 30 min, took more benadryl. She has itched all over since day of vaccination and cannot get a deep breath.
56 2021-01-27 migraine On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw ... Read more
On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw my PCC provider. Woke up 1/17 with blurry vision and continued eye pain. Talked to my Rheumatologist 1/19. I saw my PCC in person 1/20. Got sent to ER got admitted. Had an MRI and a lumbar puncture. I was diagnosed with optic neuritis by the neurologist. I continued to do 5 days of out pt iv steroids.
56 2021-01-27 pain in extremity Sore arm after dose 1 (mild, ,resolved); Mild-Moderate side effects after dose 2 (headache, fatigue,... Read more
Sore arm after dose 1 (mild, ,resolved); Mild-Moderate side effects after dose 2 (headache, fatigue, muscle aches, dizziness, chills, sleeplessness) persisting past 48 hours and ongoing but fluctuating; At 72 hours: Injection site is red, with raised welt around 2 inches in diameter, with itching and warm to touch; ongoing.
56 2021-01-27 tenderness Body aches, Tenderness under right arm - lymph node association, mid to lower back pain,
56 2021-01-27 tenderness Tenderness under arm, - lymph node association, mid to lower back, site swelling Ibuprofen 400 mg ... Read more
Tenderness under arm, - lymph node association, mid to lower back, site swelling Ibuprofen 400 mg relieved symptoms
56 2021-01-28 facial pain, tingling, numbness I feel ok during the observation period, after I left I felt pain on my face and numbness and tingli... Read more
I feel ok during the observation period, after I left I felt pain on my face and numbness and tingling. My face was swollen on the left side and my head on the left side hurt. I took some tylenol and went to bed. I had body aches. The body aches went away after the third day. Only my face hurt and it was kinda swollen. I called my doctor on the 5th day and he prescribed Gabapentin. The pain increased more and more each day.
56 2021-01-28 feeling hot, tingling close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken ... Read more
close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken and it was 166/86 (my normal BP is usually 100/60).; This is a spontaneous report from a contactable Physician (the patient). A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm, second dose, on 15Jan2021 14:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism and gastrooesophageal reflux disease, both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), estradiol, norethisterone acetate (AMABELZ), estradiol, levonorgestrel (CLIMARA PRO). Patient previously received the first dose of BNT162B2 in left arm, on 24Dec2020 08:15 AM. No other vaccine in four weeks. Vaccination Facility type: Hospital. No COVID prior vaccination. COVID was not tested post vaccination. No Known allergies. On 15Jan2021 about 5 minutes after the vaccination the patient experienced close to passing out, felt "heat waves" throughout my body, tingling, palpitations, blood pressure (BP) was taken and it was 166/86 (her normal BP is usually 100/60). No treatment was given. The symptoms slowly resolved over the next 45 minutes, with BP returning back to normal. Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "close to passing out". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-01-28 pain in extremity Body aches, Temp 100, left arm soreness treated with tylenol and ibuprofen. fever and body aches sub... Read more
Body aches, Temp 100, left arm soreness treated with tylenol and ibuprofen. fever and body aches subsided after 15 hours
56 2021-01-28 tingling CC: "Tingly hands & arms" After receiving her first series of her COVID-19 vaccine. Pt denies any di... Read more
CC: "Tingly hands & arms" After receiving her first series of her COVID-19 vaccine. Pt denies any difficulty breathing or any rashes/hives. Pt felt better after 30 mins and was cleared to RTW.
56 2021-01-28 unresponsive to stimuli She became acute short of breath. Called EMS. On their arrival she was nearly unresponsive. Bagge... Read more
She became acute short of breath. Called EMS. On their arrival she was nearly unresponsive. Bagged. NOT hypotensive. HYPERCARBIC. Difficult intubation. Transferred to our facility on VENT with bilateral pulmonary infiltrates, wheezy with size 6 ETT from outside facility.
56 2021-01-29 tingling, numbness Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands fa... Read more
Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands face lips and tongue. At 6 hrs post vaccine. Core temperature below 95. Severe headache , lightheaded dizziness at 4 1/2 post vaccine Severe muscle weakness and pain start at 8 hrs post vaccine . All symptoms last 48 hrs post vaccine Took aspirin, ibuprofen and Benadryl
56 2021-01-29 cold extremities 18 hours after the second shot, I started feeling feverish with uncontrollable chills. My extremiti... Read more
18 hours after the second shot, I started feeling feverish with uncontrollable chills. My extremities were ice cold and for about an hour I couldn't feel my right thumb. I experienced waves of fever and chills for about 6 more hours with extreme body aches, headache, joint pain, and a foggy head. I was able to go to sleep that night but woke often. I was unable to work the next day due to extreme fatigue and slept most of the day. On the 13th, I was back to normal.
56 2021-01-30 weakness, numbness Uncontrollable shivering for 3 hours, headache, numbness and tingling in hands and feet, swelling an... Read more
Uncontrollable shivering for 3 hours, headache, numbness and tingling in hands and feet, swelling and redness at injection site, swollen armpit, chest pain, extreme tiredness and slept for 22 hours, weakness.
56 2021-01-30 numbness Distal third thumb numbness. Numbness in soft palate, tingling of the lips. Resolved after given Be... Read more
Distal third thumb numbness. Numbness in soft palate, tingling of the lips. Resolved after given Benadryl P.O. Discharged home with husband driving, advise to continue Bendaryl every 4-6 hours and to follow up with PCP.
56 2021-01-31 weakness Generalized weakness; Numbness in lower lip; Prolonged malaise; Headaches; Poor equilibrium; Chest p... Read more
Generalized weakness; Numbness in lower lip; Prolonged malaise; Headaches; Poor equilibrium; Chest pain; Persistent increase in blood pressure; Intermittent tachycardia; This is a spontaneous report from a contactable nurse. This nurse reported for herself that the 56-year-old female patient who received econd dose of bnt162b2 (BNT162B2, COVID 19 Pfizer) via Intramuscular on 07Jan2021 04:00 PM on Left Arm at a single dose for covid-19 immunization. She is not pregnant. Medical history included Known allergies: Taxotere and Breast cancer. Concomitant medications included Tamoxifen. The patient previously took first dose of bnt162b2 at a single dose for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced Generalized weakness Numbness in lower lip Prolonged malaise Headaches Poor equilibrium Chest pain Persistent increase in blood pressure Intermittent tachycardia from 08Jan2021 3:00 PM. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the event was unknown. No treatment received. No COVID prior vaccination. COVID tested post vaccination included Covid test post vaccination: Nasal Swab, PCR panel on 12Jan2021 with covid test result: Negative. Information Requested on Lot/ batch number.
56 2021-01-31 migraine Shortness of breath,chills,hot sweating. Later that night legs aching like a toothache all night sha... Read more
Shortness of breath,chills,hot sweating. Later that night legs aching like a toothache all night sharp shooting pain in left shoulder couldn't sleep. Next day chills nausea aching legs migraine. Couldn't eat. Still having problems with legs.
56 2021-01-31 tingling, numbness after second dose feel like mild flu and body aches, light headache and little nusia
56 2021-02-01 weakness, pain in extremity finger joints pain and weakness
56 2021-02-01 breast pain fever, headache, muscle aches, diarrhea, nausea, breast on injection site painful, sore throat, righ... Read more
fever, headache, muscle aches, diarrhea, nausea, breast on injection site painful, sore throat, right ear ache, malaise
56 2021-02-01 feeling hot, weakness sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; se... Read more
sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; severe abdominal pain; Nausea; Injection site pain; This is a spontaneous report from contactable other hcps (including patient herself). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid19, lot number EL3248) , via an unspecified route of administration 08Jan2021 17:30 at single dose on left deltoid for covid-19 immunisation. Medical history included covid-19 the first time in Oct2020 to an unknown date , then from 16Nov2020 to an unknown date and experienced "every symptom except for vomiting". The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 18Dec2020 for covid-19 immunisation and experienced neck hurting, Shingrix Vaccine on 04Dec2020 for immunization and experienced no adverse effect. The patient experienced severe abdominal pain, nausea, Injection site pain on 12Jan2021, headache, fatigue, feeling of total lack of energy on 13Jan2021, fever on 16Jan2021. She had severe abdominal pain and nausea for three days (as reported). The caller stated she took Zofran for her nausea. The caller stated she had a rapid COVID-19 Virus test that was negative, but continued to feel queasy. She stated she had 100.5-101.8 degree fevers over the weekend, and has been sleeping a lot. Reported she woke at 4:00AM on Tuesday, 12Jan2021, with severe abdominal pain. She said the abdominal pain is better but not completely gone. Abdominal Pain Treatment: Declined any. Reported she hasn't discussed with her doctor the adverse events she has been experiencing since receiving the second COVID-19 Vaccine dose. She stated she had injection site pain for 2-3 days after receiving the second COVID-19 Vaccine dose. She said she didn't have any injection site soreness with the first COVID-19 Vaccine dose. She said she thought she was good after receiving the second COVID-19 Vaccine dose, but then on Tuesday, 12Jan2021, she woke at 4:00AM with severe abdominal pain. She said the abdominal pain came in waves. She described the abdominal pain as an 8 out of 10, clarifying the abdominal pain would be sharp and then fade away, and then the abdominal pain would cycle back around. She said she found herself standing over her toilet a few times because the abdominal pain was so severe, she thought she was going to throw-up. She clarified she had nausea and took and old prescription of Zofran she had received for vertigo years ago. She stated she did not have the Zofran NDC, Lot, and Expiration Date. Reported her abdominal pain and nausea went away by Thursday, 14Jan2021, saying the abdominal pain and nausea was less and less each day. She clarified the abdominal pain and nausea were intermittent, saying all of a sudden she would not feel good. She said her nausea has been better for the past 2-3 days. She clarified she called off work on Tuesday, 12Jan2021, and on Wednesday, 13Jan2021, she had a Rapid COVID-19 Virus Test before she started work that day (13Jan2021) to make sure that she wasn't positive for the COVID-19 Virus. She said she had a headache, no energy, and felt fatigued at work on Wednesday (13Jan2021), and Thursday (14Jan2021), but didn't take her temperature during that time. She said she didn't work on Friday (15Jan2021), but continued to have the headache, fatigue, and feeling like she had no energy. She said she didn't check her temperature until Saturday, 16Jan2021. She said she woke up Saturday (16Jan2021) at 9:40AM and went back to sleep until 11:30AM. She said she woke back up at 1:42PM and her husband told her she felt hot to the touch. She said she checked her temperature and it was 101.8 degrees. She said she checked her temperature first thing this morning (18Jan2021) because she could tell she sweated overnight, and her temperature was 100.3. She said she just checked her temperature again, and her temperature was now 99.3 degrees. She said by this afternoon, her temperature will be in the 101 range. Headache & Fever Treatment: Reported she took Naproxen (clarified as a prescription Naproxen 500mg tablet), and Tylenol (clarified as Equate brand Acetaminophen 500mg tablet) for her headache and fever on Saturday (16Jan2021). She said she took the Naproxen and Acetaminophen 500mg once in the morning, and again at night, before bed. She stated she did not take any Naproxen or Acetaminophen on Sunday, 17Jan2021. Acetaminophen 500mg tablet (Equate Brand): UPC Number: Unknown, Lot Number: 0HV1335, Expiration Date: May2022 Naproxen 500mg tablet (Prescription dispensed in round, pharmacy bottle): No NDC, Lot, or Expiration Date Reported she had another COVID-19 Virus test performed on Sunday, 17Jan2021, at 11:40AM at a drive-thru test site at Pharmacy. She clarified it was a "send-out" PCR COVID-19 Virus test, and she had not received her test results yet. She said her belly doesn't hurt anymore. She said she doesn't have a gallbladder and appendix. She said if she had the flu, the flu lasts for 3-5 days, and she is not coughing. She said she feels like now, what she felt like when she had the COVID-19 Virus the first time in Oct2020. She said she had a 12 days of severe fatigue when she had COVID-19 in Oct2020. She said her COVID-19 Virus symptoms started on 14Oct2020 with nasal congestion, and by 16Oct2020 she couldn't taste her yogurt. She said she got tested later in the day on 16Oct2020 for the COVID-19 Virus. She clarified she definitely had no sense of smell or taste on Friday, 16Oct2020. She said on Thursday, 15Oct2020, she kept falling asleep in the evening, saying that never happens. She said on Friday, 16Oct2020, she had a fever of 100.3, as well. The outcome of the events severe abdominal pain, nausea was resolved on 14Jan2021, of Injection site pain was resolved on an unspecified date, of sleeping a lot and she sweated overnight was unknown, of other events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of abdominal pain, nausea and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-02-01 flushing Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Pa... Read more
Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Painful urination; Bilateral eye pain; Chills/sporadic chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via Intramuscular on left arm on 12Jan2021 12:00pm as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma, hypothyroidism, supraventricular tachycardia, Sulfa allergy, dust allergy, Maple trees and Pine Trees allergies, gastrooesophageal reflux disease. Concomitant medication included sertraline, metoprolol, estradiol, levothyroxine, pantoprazole, fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen (ADVIL). The patient previously took Augmentin and experienced drug hypersensitivity. Historical vaccine includes first dose of BNT162B2, lot number: EH9899, on22Dec2020 08:15 AM, via intramuscular on Left arm. On 13Jan2021, the patient experienced facial flushing, HTN, Tachycardia 90-120 for 30hrs, headache, Body aches, painful urination, bilateral eye pain, chills. Then, another 48 hours of sporadic facial flushing and sporadic chills. The patient underwent COVID-19 testing via Nasal Swab post vaccination on 16Jan2021 with negative. The outcome of the events sporadic facial flushing and sporadic chills was recovered on 16Jan2021; while the rest of the events were recovered on 14Jan2021. The patient is not pregnant at the time of vaccination. No treatment was given for the events.
56 2021-02-01 hypersensitivity of all senses left armpit and under arm became swollen and tender to the touch; left armpit and under arm became s... Read more
left armpit and under arm became swollen and tender to the touch; left armpit and under arm became swollen and tender to the touch; arm remained somewhat sensitive to the touch; Patient was also extremely tired; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL1284, on 06Jan2021 09:30 Intramuscular at single dose in left arm for COVID-19 immunization. Medical history included Anxiety and depression, Chronic pain in right foot, tendinopathy of right foot since 2015, Derangement of medial meniscus, Environmental allergies, Fatty liver H/O, hypothyroidism since 25Jan2013, Health care maintenance, Hyperlipidemia since May2016, thyroid nodule since 25Jan2013, Obesity, Prediabetes. Concomitant medications included salbutamol (ALBUTEROL), levothyroxine and omeprazole. The patient previously received first dose of BNT162B2 lot number=EH9899 on 16Dec2020 11:00 AM via Intramuscular at left arm at 56-year-old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and tender to the touch on 07Jan2021 08:00. Notified primary care physician during routine visit, PCP advised to notify her if symptoms did not resolve. Swelling resolved 4 days after onset, arm remained somewhat sensitive to the touch. Patient was also extremely tired for 2 days after the vaccine but otherwise fine. No treatment was received for all events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The outcome of all events was resolved.
56 2021-02-01 pain in extremity, weakness General weakness; nausea; stomach cramps; high blood pressure; aches all over the body especially in... Read more
General weakness; nausea; stomach cramps; high blood pressure; aches all over the body especially in lower extremities; aches all over the body especially in lower extremities; severe headaches; This is a spontaneous report from a contactable nurse reported for self. This 56-year-old female patient the second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) via an unspecified route of administration on 12Jan2021 at single dose in left arm for COVID-19 immunisation. The patient is not pregnant. The patient had no other medical history. The patient had no known allergies. The patient concomitant medication was none. The patient previously received first dose of BNT162B2 (Lot number EL0140) at 22Dec2020 09:00 AM at single dose in left arm for COVID-19 immunisation. The patient experienced general weakness, nausea, stomach cramps, high blood pressure, aches all over the body especially in lower extremities, severe headaches on 17Jan2021. These events resulted in emergency room/department or urgent care. The patient received amlodipine besilate (NOVARSC) 5mg, hydroxyzine (ATARAX) for treatment. The patient had no COVID prior and post vaccination. The patient was recovering from the events.
56 2021-02-01 pain in extremity, weakness Shot given on January 25. Legs sore most of week. Saturday evening, January 30 started having extre... Read more
Shot given on January 25. Legs sore most of week. Saturday evening, January 30 started having extreme soreness and weakness in hips. Extreme pain while standing and difficulty walking. Persisted and went to see regular doctor on 2/2/2021. No fever or other symptoms. Gave Toradol shot in hip. No relief. Soreness and difficulty walking continues
56 2021-02-01 pain in extremity After dose #1- sore left deltoid lasting for 1 week and severe fatigue lasting for 48 hrs. After do... Read more
After dose #1- sore left deltoid lasting for 1 week and severe fatigue lasting for 48 hrs. After dose #2-12 hours post injection, myalgias, chills and cough set in. Took to bed and became febrile @100.4, noted a metallic taste in mouth a/w headache. Lasting 48 hours.
56 2021-02-01 unresponsive to stimuli Employee was found unresponsive in floor at her home. EMS arrived and person had expired.
56 2021-02-02 weakness, inability to speak syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck througho... Read more
syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck throughout body; unable to turn head; generalized weakness; hypotension; shortness of breath; unable to speak; chills; diaphoresis; severe pain radiating from neck throughout body; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 18Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, shellfish. Concomitant medication included celecoxib (CELEXA), levocetirizine dihydrochloride (XYZAL), acetaminophen, ibuprofen, naproxen sodium. There were no other vaccines received in four weeks. The patient did not have Covid tested post vaccination. Upon awakening early morning after injection on 19Jan2021 04:00, the patient had severe pain radiating from neck throughout body, unable to turn head, generalized weakness, syncopal event, hypotension, increased respiratory rate, shortness of breath, unable to speak, unable to move, chills, diaphoresis, emergent to emergency department, received Intravenous NS bolus as treatment. Electrocardiogram (EKG), BMP, complete blood count (CBC), labs were Within Normal Limit on 19Jan2021, discharged home, slept all day. Feeling much better second day after injection. The reported events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of unable to move, syncopal event, increased respiratory rate, severe pain radiating from neck throughout body, unable to turn head, generalized weakness, hypotension, shortness of breath, unable to speak, chills, diaphoresis. The outcome of the events was recovered in Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
56 2021-02-03 weakness, cold sweat severe stomach pains; bad headache; dizzy; Didn't have any energy and strength; Cold sweats; Nauseou... Read more
severe stomach pains; bad headache; dizzy; Didn't have any energy and strength; Cold sweats; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 20Jan2021 at 02:45 PM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history included chronic lyme disease. Concomitant medications were not provided. Patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 23Jan2021 at 12:00 AM patient had severe stomach pains with a bad headache. Shortly after she got dizzy, did not have any energy and strength. She had cold sweats. Patient tried sips of water, but it made her nauseous. This all happened all at once and it hit patient hard in the middle of her work. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events.
56 2021-02-03 discomfort In the beginning I didn't have any issues, I was fine. I went to bed and woke up at 2am and started ... Read more
In the beginning I didn't have any issues, I was fine. I went to bed and woke up at 2am and started vomiting like I never before and had diarrhea , a fever of 101.3. My fever dropped in three hours back to normal which was weird. It was strange. The diarrhea lasted for days, it was uncontrollable . The vomiting lasted for three days, it was non-stop. I had this headache that was unbelievable . Since having Covid I get headaches daily. I had Covid in March 2020. I lost 4lbs in three days and I called my Dr. He said You need to go the ER right now. I went to the ER and had to wait three hours, I had aches and pain like the flu, I was totally out of it. They did a Cat scan, and blood work was normal. They gave me IV fluids, IV Tylenol and Tramadol. They did a Covid and flu test, both were negative. Then they gave me a shot of Fetanal , that took away my headache for 30 minutes. At this point I didn't have any more vomiting or diarrhea . I stayed about 8 hours in the ER and went home. I was told by my Dr. not to get the next shot.
56 2021-02-03 tingling, face paralysis 56 year old female presents with complaint of tingling and numbness that she noticed to her lower le... Read more
56 year old female presents with complaint of tingling and numbness that she noticed to her lower left jaw. It occurred yesterday around 3 PM after she received her Covid vaccination. She states that then started to move up to her left cheek but has now gone back down just to the lower left jaw. It is in a specific region of that area. She states also that she is having a fever today and generalized body aches that are moderate in nature. She also notes some urinary frequency without dysuria or hematuria. Patient took Tylenol this morning around 6 AM. She initially tried to swallow the pill and felt like she was going to choke on it and spit the pill up. She then sat down for a few minutes and was then able to take the pill. She denies any actual stridor or wheezing. No focal weakness or numbness of one arm or leg. No change in speech. Differential diagnoses include but are not limited to: CVA, TIA, anxiety reaction, paresthesia, metabolic process, bleed, vaccine reaction. 56-year-old female with paresthesia to the left chin. Otherwise normal neurologic examination. The TPA window given symptoms started yesterday. I will get a head CT but I do not feel the patient needs an MRI. Given the fact the patient does have autoimmune disorder, blood cultures and lactic acid obtained. I suspect that her fever is in response to her Covid vaccine yesterday. Covid test negative. Urinalysis no evidence of UTI. Chest x-ray is clear. Head CT negative. On reevaluation after Motrin patient feels much improved. At this time I think she is stable for discharge to home. I do not think this is Bell's I am finding no facial weakness on my examination. Follow-up and return precautions discussed patient understood
56 2021-02-04 hot flush After vaccines I get hotflashes all day and night. My temperature has remained normal; This is a spo... Read more
After vaccines I get hotflashes all day and night. My temperature has remained normal; This is a spontaneous report from a Non-contactable Other-HCP (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EH9899, via an unspecified route of administration from 21Dec2020 16:00 to 21Dec2020 16:00 (at the age of 56-years-old) as a single dose in the right arm, for COVID-19 vaccination. The patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from 11Jan2021 as a single dose in the right arm lot number EK9231, for COVID-19 vaccination. Medical history included autoimmune illnesses from an unknown date and unknown if ongoing , many allergies from an unknown date and unknown if ongoing , occasional hot flashes (before vaccines I got only occasional hot flashes) from an unknown date and unknown if ongoing Before vaccines I got only occasional hot flashes. There were no concomitant medications. The patient was administered the vaccine in hospital. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced before vaccines she got only occasional hot flashes. After vaccines she got hot flashes all day and night on 22Dec2020. Her temperature has remained normal. No treatment was received for the event. The patient underwent lab tests and procedures which included temperature: remained normal on 22Dec2020. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
56 2021-02-04 numbness, migraine with aura, discomfort, tingling Woke up suddenly at 1am on 2/5/2021 with increasing neurological symptoms similar to a migraine aura... Read more
Woke up suddenly at 1am on 2/5/2021 with increasing neurological symptoms similar to a migraine aura. There was a no obvious pain, but a sense of deep heaviness/pressure/sinking/dizziness in my head and body. Bilateral tingling/numbness, but still was able to move legs and arms. Did not lose consciousness. My first thought was seizure or stroke. I later spoke to an infectious disease doctor that thought it may be brain vessel spasm due to inflammatory response from vaccine. I had no side effects from first COVID shot other than arm pain.
56 2021-02-04 pain in extremity Arm aching/arm started aching on 20Jan2021, little by little and was worsen on 21Jan2021; arm aching... Read more
Arm aching/arm started aching on 20Jan2021, little by little and was worsen on 21Jan2021; arm aching, it is just like when got a flu shot three months ago, arm hurts happened; Got the COVID Vaccine on 20Jan2021. second dose will be on 17Feb2021.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL929), via an unspecified route of administration at site of left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing Type 2 diabetes (diagnosed about 10 years ago) and ongoing high cholesterol (diagnosed about 10 years ago). Concomitant medications included ongoing unspecified blood pressure medication to protect her organs. She did not have any issues with her blood pressure. The only thing she was experiencing is her arm aching. But it was just like when she got a flu shot, her arm hurts happened. She got the flu shot on Oct2020 (about 3 months ago), along with the shingles shot and the pneumonia shot. Her second dose will be on 17Feb2021. Her arm started aching on 20Jan2021 little by little and was worsen on 21Jan2021. No treatment received for adverse events. She did not like to take medication and pain pills. The outcome of events was not recovered.
56 2021-02-04 tremor chills, shakes, body aches, 100.8-103.9 fever, fatigue
56 2021-02-05 weakness 56-year-old female presents via video visit today for symptoms that started after her second Covid v... Read more
56-year-old female presents via video visit today for symptoms that started after her second Covid vaccine on January 29. Patient states that she started developing headache 1 week ago now with extreme fatigue, chills, body weakness and nausea. Patient has no congestion, cough, fever, soreness, vomiting or diarrhea. She was doing fine the first few days after the vaccine but today symptoms worsen with new onset of nausea, weakness. She has been drinking turmeric tea. Has not been taking any NSAIDs. She feels "winded" even doing a load of laundry. She also reacted to the first dose of vaccine with a prolonged headache.
56 2021-02-05 difficulty speaking 56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her secon... Read more
56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her second dose of the Pfizer COVID-19 mRNA vaccine and subsequently developed generalized pruritis five minutes after. She developed similar symptoms 6 hours after receiving the first dose, but this time was more severe. She arrived to the emergency department and after 15 minutes began to develop a cough, increased work of breathing, and voice changes. She received 0.3 mg epinephrine subcutaneously and albuterol nebulizers. Over her three hours in the department she received famotidine, 125mg methylprednisolone, diphenhydramine, an additional dose of epinephrine and 4x albuterol nebs. However, he dyspnea continued to return, and she was admitted. Improved overnight and was discharged HD2. widespread pruritis initially 5min post-Pfizer vaccination (2nd dose). Progressed to severe coughing, dyspnea requiring repeated doses of epinephrine and albuterol. Admitted to intermediate unit for further cares. Noted to have had mild delayed pruritis prior to first dose of pfizer vaccine.
56 2021-02-05 pain in extremity Received dose #2. That evening, developed headache and dizziness, arm pain. 1/7-arm pain radiating d... Read more
Received dose #2. That evening, developed headache and dizziness, arm pain. 1/7-arm pain radiating down the ribs, extreme fatigue, body aches, dull headaches. 1/8- chest tightness, temp 99.8, body aches, fatigue, dull headache. Only able to dose with Tylenol. 1/12-follow up: states doing well and all symptoms subsided.
56 2021-02-05 pain in extremity Right Arm ache and Head Pressure and Headache. Used icepack for right arm and used cool compress fo... Read more
Right Arm ache and Head Pressure and Headache. Used icepack for right arm and used cool compress for headache.
56 2021-02-06 flushing "feeling flushed and tight neck"
56 2021-02-07 feeling hot Headache 1 hour after vaccine. Chills the next morning at 6:00am, followed by headache and periods o... Read more
Headache 1 hour after vaccine. Chills the next morning at 6:00am, followed by headache and periods of being hot after taking Advil
56 2021-02-07 night sweats Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - w... Read more
Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - went home & went to bed, slept through night and had sweats on and off. Post vaccine day 2- Fatigue, abdominal discomfort and pressure, constipated. Nausea and vomiting developed, with dehydration. Constipated, symptoms consistent with Crohn's flare. Went to ER but due to long wait was not seen by physician. Gradually improved, saw GI specialist day 4, felt much better by day 6. Bowels not quite back to normal 2 weeks later
56 2021-02-07 throat numbness, numbness, weakness, tingling within 5 minutes of receiving the vaccine, my left arm became numb & weak & resolved by the next da... Read more
within 5 minutes of receiving the vaccine, my left arm became numb & weak & resolved by the next day; 1-2 hours later my legs/feet from the knees down became numb/tingling with tightening muscles; 2 hours later left side entire face became numb with puffy left eye lid which lasted for 8 days; by the 8th day my symptoms began to resolve only to return with 4 days with left face/throat numbness & left side numbness/tingling with tightening forearm muscles both hands/fingers/arms from elbows down & numbness/tingling/muscle tightening in both legs/feet/toes from the knees down along with pain in both knees which lasted another 2 days; I continue to have some residual symptoms of numbness on the left side of my face that comes and goes as well as the same symptoms of numbness/muscle tightening and tingling in both legs/feet that comes & goes.
56 2021-02-07 tenderness This was my first vaccine. I had Covid last March. As of Jan 2021 i still had some antibodies in my ... Read more
This was my first vaccine. I had Covid last March. As of Jan 2021 i still had some antibodies in my body. After 12 hours i began to get chills and my skin was very achey. I took advil because when i was very sick with covid and too tylenol every 6 hours it didn't lower my temperature or take away any of my pain. two hours later, i had a stomach ache. While having a bowel movement i fainted onto the floor and ended up with a black eye. i do not pass out from having bowel moments otherwise. My cheekbone was sore to the touch for a week.
56 2021-02-09 pain in extremity Face and scalp itching, headache, fever, pain to soles of feet, extreme fatigue, body and joint pain... Read more
Face and scalp itching, headache, fever, pain to soles of feet, extreme fatigue, body and joint pain. Started approx 3 hours after injection and is continuing on day 3, but symptoms are lessening some. Tylenol and Motrin and rest treatment. Contacted my physician for further advice or treatment needed.
56 2021-02-10 feeling hot, cold sweat, pain in extremity While waiting the 15 minutes after vaccine, after 8 minutes, my body got very hot, clammy, sweating,... Read more
While waiting the 15 minutes after vaccine, after 8 minutes, my body got very hot, clammy, sweating, and about to pass out. Nurse took my oxygen levels and heart rate, below 40. Blood pressure very low. Called 911. Put oxygen on me, gave me Epipen, and checked sugar levels. Next heart rate, a few minutes after first one, 40 heart beats and blood pressure coming back up. Gave me water and orange juice. Next check, heart rate up to 88 and blood pressure they said was getting back to normal but don't remember numbers. I was still trying to feel back to myself after a half hour to 45 minutes. My doctor says not to get 2nd dose in which I'm due on 2/21/2021. I started to feel back to myself around an hour later. I did not go to hospital due to me feeling better. After shot, regular symptoms, sore arm, fatigued, lymph nodes felt swollen, and sniffles and sneezing. No fever. I called my physician on 2-1-2021 to let her know what happened.
56 2021-02-11 depressed level of consciousness, speech disorder, feeling hot I received my vaccine at 6:55am on 12/30/2020. I waited about 20minutes in the observation area. I f... Read more
I received my vaccine at 6:55am on 12/30/2020. I waited about 20minutes in the observation area. I felt fine and went to work. It was a normal day of rooming patients, I had lunch of yogurt and blueberries about 2 pm I started feeling very hot and "off". I went to the front of the office and checked my temp which was normal. As I walked down the hall to the back of the office I started feeling very nauseous, dizzy and my legs felt like jello. I sat down in my chair and got more dizzy so I put my head in my hands. The other MAs were asking me if I was ok but I couldn't think of the words and then I couldn't get the words out for about 10 seconds. When I did arouse again I was told I was slow to answer questions after
56 2021-02-11 pain in extremity, burning sensation 1/25 L sore shoulder. 1/26 L sore shoulder. 1/27 L burning sensation running down arm from shoulder... Read more
1/25 L sore shoulder. 1/26 L sore shoulder. 1/27 L burning sensation running down arm from shoulder to wrist. 1/28 L forearm and wrist began to swell and be very painful, complete loss of all wrist range of motion this continued thru Monday 2/8 This was so painful that I sought medical treatment from a MUSC health, Lanc MD on 2/5. He examined my wrist and sent me for an X-ray, X-ray was negetaive. Monday 2/8 the pain was subsiding from my wrist and began to start in my L shoulder. Wed 2/10 The pain had moved under my breast radiating from my L front around my back, severe along with shortness of breath. I went to ER for a complete work up including a CT to rule out a blood clot. All test negative all blood work normal. Except it did reveal that I had a UTI. I have never had a UTI in my life. I was started on a anitibiotic for the UTI. I still have the pain under my L breast. Unknown reason.
56 2021-02-12 pain in extremity, hypersensitivity of all senses Arm, shoulder, neck soreness and extreme sensitivity to touch. Can wear a bra because of the sournes... Read more
Arm, shoulder, neck soreness and extreme sensitivity to touch. Can wear a bra because of the sourness. I also have a small area under the clavicle where there is a lump that also is extremely sensitive to touch. I developed a cold sore (herpes) on my chin. This is an area I've never had an outbreak on. This is still the case 4 days later.
56 2021-02-12 tremor, feeling jittery Within 20 minutes I began to feel heart racing, shaky/jittery - resting heart rate was around 140 pe... Read more
Within 20 minutes I began to feel heart racing, shaky/jittery - resting heart rate was around 140 per FitBit watch; I was in the 30 minute observation line due to allergies with other medication; staff provided me with 50 mg. of liquid Benadryl - needing to help me hold/bring to lips due to shaking; called on-site medics - noted increased HR, increased BP, conducted EKG ; attempted IV x4; called paramedics for transport to the Hospital - attempted/placed IV but infiltrated; at hospital 6th attempt at IV was successful and provided Saline; PVC's were noted on monitor but EKG was normal; HR remained increased; BP gradually returned to normal; HR decreased but did not return to normal until 24+ hours post-vaccination; released from hospital after about 4 hours of observation
56 2021-02-14 hot flush After first dose severe headache for two days with some dizziness. After second dose sleepless that... Read more
After first dose severe headache for two days with some dizziness. After second dose sleepless that night then around 4AM chills and hot flashes with sweating, got up to walk around and had shortness of breath, teeth chattering, slept most of Friday had aches, headache, nausea.. had to concentrate on not vomiting, heightened sense of smell, had 101.7. Saturday initially felt ok the terrible headache and nausea, achey and still 101.7 temp. Sunday initially felt good and then with the headache, nausea, shortness of breath, achey, 101.7 temp. Monday felt ok all day until around 5pm and then chest hurt and shortness of breath.
56 2021-02-14 pain in extremity My arm is hard and feels like I have a knot in my arm. The area where I got the injection is warm
56 2021-02-14 tingling, feeling cold 1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels res... Read more
1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels rested or wants/needs to sleep, a lot. Noticed abdominal pain, but did not connect the two. 2/11/2021- 2nd dose- Two hours later (approx) moderate pain at site, my head/mind felt "off", out of sync like one side of brain slower, affected balance. It was strange, and unpleasant. 2/12/2021- Groggy, face/eyes swollen, did not feel well, but not so bad I could not go to work. It was a 50 mile drive, and as I drove the same feeling of not thinking straight did not want to drive. The feeling of being unwell escalated quickly. Congestion, muscle aches throughout, sore throat, chills, and a need to catch my breath caused dizziness. I pulled over, called work, and made my way home where I went directly to bed. My head ached, abdominal (sharp) pains, especially after ingesting fluids. or food similar to gall bladder pain, but not close to its worse intensity still, continues. 2/15/2021- Update- Nearly 96 hrs. passed: What remains is: Feeling exhausted, need to sleep, more frequent and intensifying abdominal pains, headaches, pain in left lung/easily winded, and site pain expansion. Injection arm (left) pins & needles, and fingers ice cold, neck pain (stiffness).
56 2021-02-14 tingling Numbness lower face; swelling lower face and tongue; lump in throat (throat closing); extreme thirst
56 2021-02-15 bell's palsy left-sided bells palsey
56 2021-02-15 feeling jittery, tremor patient reported to observers feelings of anxiety, jitteriness, shaky hands, and chest itchiness. As... Read more
patient reported to observers feelings of anxiety, jitteriness, shaky hands, and chest itchiness. Assessment performed respirations counted and were within normal limits, clear respiratory sounds. had patient sit near the door for cooler air, symptoms continued and Benadryl was given. Paramedics arrived and further assessment was completed and she refused to received further treatment in the ambulance and was allowed to go home. LVN and RN assessed further and patient stated symptoms no longer present 20 minutes after Benadryl was given.
56 2021-02-15 flushing, pain in extremity 1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt... Read more
1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt went to work and felt out of it, overall unwell feeling, went to walk in clinic, blood pressure was high even after meds, EKG showed tachycardia but normal rhythm, pt went home went to bed at 2 PM slept until next morning, 1/9/21 fatigue, swollen lymph node under left arm, small lymph node in neck also swollen, headaches, flushed/grey looking, as of 2/16/21 pt is feeling much better
56 2021-02-15 numbness 2/4 Headache, dizziness, neck and shoulder aches, left hand and foot numbness which continued into 2... Read more
2/4 Headache, dizziness, neck and shoulder aches, left hand and foot numbness which continued into 2/5.
56 2021-02-16 weakness Vomiting, fevers up to 102, dizziness, weakness, body aches.
56 2021-02-16 feeling cold, burning sensation, pain in extremity massive headache, 11 hours post vaccination at midnight. Extreme arm pain, throbbing, burning, join... Read more
massive headache, 11 hours post vaccination at midnight. Extreme arm pain, throbbing, burning, joints felt swollen, extreme abdominal pain (like someone wrenching my intestines and organs), aching neck, body pains and felt like I was freezing btwn midnight and 3 am. Had lay still in a fetal position for it to calm down at 3am.
56 2021-02-16 numbness, tingling Shortly after vaccine, just like with 1st dose, I experienced right arm numbness and tingling. This... Read more
Shortly after vaccine, just like with 1st dose, I experienced right arm numbness and tingling. This did resolve by evening. On the morning of 2/12/21 I awoke with vertigo, emesis and headache. I'm not prone to frontal headache which progessed to migraine symptoms - i.e. sensitivity to noise, light and motion. The vertigo and headache lasted into the following morning. This resulted in a absence from work on 2/12/21.
56 2021-02-18 pain in extremity Arm pain but it was tolerable, but extreme joint pain, as well as extreme muscle pain, fatigue, and ... Read more
Arm pain but it was tolerable, but extreme joint pain, as well as extreme muscle pain, fatigue, and eye pain. Tinnitus and dizziness. Also had chills. Remained pretty consistent for a day and half.
56 2021-02-18 tingling Tingling of the feet, fever, chills and body pains
56 2021-02-19 feeling cold, cold extremities Started to have chills & achy ness around six. By 7:30 very bad body aches- painful joint aches espe... Read more
Started to have chills & achy ness around six. By 7:30 very bad body aches- painful joint aches especially in thumbs/hands, headache. Absolutely freezing and skin was cold to touch but no fever at any point. Went to bed and this continued until about 6:00 AM. At 2:00 am was starving- so had cookies and milk. By 7:00 AM on 2/8/21 felt better except for a bad headache which lasted until 6:00 PM. Then all symptoms were gone. Never had a fever. Hands still achy, it seems to flair up arthritis.
56 2021-02-21 muscle twitching, flushing, tremor Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was cal... Read more
Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was called to transport pt to ED and pt was given a epi pen in observation area where pt received epi pen, pt vitals were BP Right arm: 135/81 HR:117 O2 SAT: 100% on RA 9:18AM 56 y.o. female with a past medical history of hypothyroidism, GERD, anxiety, and Hashimoto's thyroiditis (on levothyroxine) presenting with reported allergic reaction. Patient reports that she had received the COVID vaccine today and 10 minutes later, started to have room-spinning dizziness to the point that she thought she was going to fall out of her chair. She also reports that she started to shake, had shortness to breath, and felt her heart rate increase. Patient had notified staff at the vaccination center and was immediately administered an Epi pen to her left thigh and brought down to the ED. She states that she then started "twitching everywhere" and notes chills as well as a scratchy throat, which are still present. She denies any previous similar symptoms as well as any feelings of anxiety prior to the vaccine or difficulty breathing. She reports an allergy to bees and seasonal allergies, but denies any other known drug allergies. No evidence of anaphylaxis or airway compromise. Discussed rebound potential; feel home observation reasonable. Instructed on antigen avoidence. Patient reports she received the vaccine and epinephrine around 9am. She was observed in the ED for 4 hours post injection without complication. Reports shakiness and tingling after epi has resolved. Patient feels better by 1pm and goes home.
56 2021-02-21 pain in extremity, weakness Pt reports 4 days after taking the Pfizer COVID vaccine she developed unrelenting pain and soreness ... Read more
Pt reports 4 days after taking the Pfizer COVID vaccine she developed unrelenting pain and soreness to her left arm followed by general myalgias to her body and weakness. She states she sx have not resolved and has only been taking ASA. Rx Voltaren gel and Tizanidine refill given.
56 2021-02-22 flushing, hot flush Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes... Read more
Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes; This is a spontaneous report from a contactable nurse. A 56-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3302) via intramuscular, on right arm on 02Feb2021, 10.30 at single dose for COVID-19 immunization. The medical history included allergies to bees and nickel, GERD (Gastro-oesophageal reflux disease). The concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM) on an unknown date in 2021. The patient previously received historical vaccine, first dose of bnt162b2 (Brand: Pfizer, Lot number: EL0140) via intramuscularly on left arm at 9.30 on 12Jan2021 for COVID-19 immunization. It was reported that at 10.45 on 02Feb2021, the patient experienced chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes. The patient was not pregnant at the time of vaccination. The patient received most recent COVID-19 vaccine at nursing home/senior living facility. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient received Tylenol Pm within 2 weeks of vaccination. The patient visited emergency room for the events. Therapeutic measures were taken because of events via oral and subcutaneous. The patient had not diagnosed with COVID-19 prior to the vaccination and since the vaccination. The outcome of the events was recovered on an unknown date in 2021.; Sender's Comments: The association between the events chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes with BNT162B2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
56 2021-02-22 tingling Since the vaccine, I have had intermittent tingling of the tips of my fingers. It is all day, includ... Read more
Since the vaccine, I have had intermittent tingling of the tips of my fingers. It is all day, including during the night but it comes and goes. Both hands have the tingling finger tips.
56 2021-02-23 flushing Approx 10 minutes after the immunization the patient started showing s/s of difficulty breathing and... Read more
Approx 10 minutes after the immunization the patient started showing s/s of difficulty breathing and c/o itching. The patient was very flushed. Mouthed "I can't breathe". Wasn't able to speak a full sentence. Staff at the clinic first administered IM Benadryl out of the emergency bag, with Epinephrine on stand-by. About 2 minutes after the Benadryl was given, she started showing signs of breathing easier, and was starting to speak to staff. She said her doctor's office was across the street and he told her to go to his office if there was any reaction. She was able to walk out on her own, accompanied by her friend who was able to take her to her doctor's office.
56 2021-02-23 pain in extremity, weakness I had chills, weakness and then fever; weakness; sore arm and soreness under armpit
56 2021-02-24 cold sweat, tingling Chest pain, difficulty breathing, tingles in the face, tongue swelling, cold sweats
56 2021-02-24 flushing Patient 56 years old presenting after adverse reaction to the COVID-19 vaccine. Patient reports fee... Read more
Patient 56 years old presenting after adverse reaction to the COVID-19 vaccine. Patient reports feeling very flushed and had itchy throat. Patient reports it went away after few minutes and then came right back. Patient denies any shortness of breath or difficulty swallowing. Patient denies any lip, tongue swelling. Patient did not take anything prior to arrival. Patient has had anaphylactic reaction to chemo before but never any vaccine.
56 2021-02-24 pain in extremity Shoulder soreness, day after shot. Arm soreness and painful for over two weeks with severe pain and ... Read more
Shoulder soreness, day after shot. Arm soreness and painful for over two weeks with severe pain and arm mobility pain began after three and diagnosis of SIRVA, shoulder injury related to vaccination administration four weeks after vaccination.
56 2021-02-25 facial paralysis To whom it May concern: I want to report that after the first dose of Pfizer's COVID-19 vaccine I su... Read more
To whom it May concern: I want to report that after the first dose of Pfizer's COVID-19 vaccine I suffered from peripheral facial paralysis and it affected my mouth. My right upper lip does not rise and I have trouble eating, drinking, and washing my mouth. This is the first time something like this has happened to me. Thanks for your attention.
56 2021-02-25 mild one side paralysis, inability to speak, facial paralysis 15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport ... Read more
15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport to ER, Left side weakness, loss of speech. Er evaluated for sudden onset left sided weakness, facial droop.Code stroke was called CT angiography was unremarkable and patient admitted for bp control. Bp normalized with Clonidine , neurological exam is stable. Md felt that thus was a combination adverse reaction to vaccine in combination with Wellbutrin. Discharge after 24 hours
56 2021-02-25 numbness Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As... Read more
Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As the day went on she realized that her ear was ringing. It started as a buzzing and now a high pitched ringing that she still has in her left ear. She also had a nose bleed that occurred twice on her right nostril. She has had nose bleeds in the past, but none recently. She was sitting working and her nose just started bleeding. The vaccine site itself was sore, minor and not unbearable. It's just the humming and buzzing in her ear that will not go away.
56 2021-02-26 pain in extremity Delayed reaction to both shots. 11-12 days after, low grade fever ( continues) Lower leg pain, mild... Read more
Delayed reaction to both shots. 11-12 days after, low grade fever ( continues) Lower leg pain, mild chills each evening.. last shot 2/11
56 2021-02-27 numbness, tingling Almost immediate left shoulder tingle. Tingle progressed up to shoulder, collarbone area, left side... Read more
Almost immediate left shoulder tingle. Tingle progressed up to shoulder, collarbone area, left side of neck, underside of chin. Some numbness accompanied the tingling. Left cheek and left ear felt hot (internally). These symptoms never worsened. Subsided approximately 2-3 hours after vaccination. About 6 hours later, my left calf was incredibly itchy. I took a Benadryl and went to bed. Felt normal the next day.
56 2021-02-28 cold sweat, feeling hot almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very ... Read more
almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very low; kept taking my Blood Pressure and pulse ox. Both very, very low; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot: reported as 96.8), via an unspecified route of administration in the left arm on 31Jan2021 14:15 at a single dose for covid-19 immunization. The patient's medical history included Lupus, Fibro, Hyperthyroidism, Hashimoto's, IBS all from an unknown date. Patient has no known allergies. Concomitant medication included pantoprazole, xylometazoline hydrochloride (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]), vitamin c [ascorbic acid], vitamin d3 and calcium (CALCIUM). 15 minutes after the shot while waiting, 8 minutes into it the patient felt dizzy, clammy, hot, and almost passed out. Nurse gave patient oj, oxygen, Epipen, checked sugar, and kept taking her blood pressure and pulse ox. Both very, very low until it came back up within 20 minutes. The patient declined hospital due to feeling better. Called the doctor next day to discuss what happened. She recommended no 2nd shot. The outcome of the events was recovered. The patient has not had Covid prior to vaccination and patient has not tested post vaccination.
56 2021-02-28 difficulty speaking Since the vaccine I have noticed an increase in throat irritation--I cannot talk or sing well.
56 2021-02-28 hot flush, feeling hot At 10:45 AM pt c/o feeling "hot" states gas "hot flashes" Offered water to drink, with resolution o... Read more
At 10:45 AM pt c/o feeling "hot" states gas "hot flashes" Offered water to drink, with resolution of symptoms. No nausea or itching. BP 110/72, HR 66, SO2 93
56 2021-02-28 pain in extremity, muscle spasms legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing mo... Read more
legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat; sore arm; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 09Jan2021, at single dose, for COVID Prevention/COVID-19 immunization. Medical history included heart palpitations. Concomitant medication included unspecified medication for heart palpitations. The patient did not receive any other vaccines on the same day as BNT162B2. On 09Jan2021 (the same day as the patient received the vaccine), she developed sore arm which went on about for three days. The patient reported she put rubbing alcohol on it and that helped. On 12Jan2021 (day three after the vaccine), the patient experienced leg cramps and stomachache which went on about for 24 hours. The patient reported that she has a history of heart palpitations, but when she got the vaccine, on 12Jan2021 (day three after the vaccine), she felt her heart started rushing more, she had rapid heartbeat, but then she got it under control. She reported she has some pills for that, so she took an extra dose of her pills and that helped out with the palpitation. The patient recovered from the event sore arm on 12Jan2021; from leg cramps and stomachaches on 13Jan2021; and from "has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat" on an unspecified date.
56 2021-03-01 burning sensation, tingling On Tuesday morning after receiving 2nd vaccination the previous Friday afternoon, I suddenly broke o... Read more
On Tuesday morning after receiving 2nd vaccination the previous Friday afternoon, I suddenly broke out in hives on both arms and across upper torso that alternated between itching and burning like fire. It quickly spread over entire body. I called my PCP to speak to a nurse and while on the phone, I begin experiencing tingling around nose and mouth, nose stuffed up making breathing difficult, and tongue became numb. PCP office told me to hang up and go to the nearest emergency room.
56 2021-03-02 numbness After getting the vaccine and driving home, one side of my face started to feel like it was getting ... Read more
After getting the vaccine and driving home, one side of my face started to feel like it was getting a little numb. It has stayed the same all day and has not gotten worse. There has been no facial drooping. Also, I have had a metal taste in my mouth.
56 2021-03-02 numbness VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CL... Read more
VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CLAVICAL AREA, NUMBNESS IN HANDS AND FINGERS, RAISED BLOOD PRESSURE, 103F FEVER on DAY AFTER SHOT
56 2021-03-02 pain in extremity 12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination Later that evening, I had tightness on R s... Read more
12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination Later that evening, I had tightness on R side chest. Rapid HR. Pulse 144. Lasted 3-4 minutes. Called 911. HR had gone back down to 78, normal BP, normal EKG. Tachycardia 1/11 lymph nodes swollen under armpit on R side. Sore arm. Had another episode 2 days later; Tachycardia. Went to Dr 1/13/2021. Full work up. Started on BP medicine.
56 2021-03-02 tremor tremors of hands, feeling like shaking inside all over, difficulty texting, typing, and signing my n... Read more
tremors of hands, feeling like shaking inside all over, difficulty texting, typing, and signing my name
56 2021-03-03 weakness Onset of symptoms was about 15 hrs following injection: Severe reflux and gastric distress (nausea);... Read more
Onset of symptoms was about 15 hrs following injection: Severe reflux and gastric distress (nausea); chills; fever to 100.8; muscle, bone and joint aches; severe fatigue; weakness; slight headache, no appetite. Alleviated somewhat with naproxyn sodium and benadryl. I also felt like I had cardiac arrhythmias. Slept most of day on 2/27. Felt improved morning of 2/28 and back to "normal" Monday 3/1.
56 2021-03-03 numbness swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbnes... Read more
swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration at the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 30Jan2021 10:45, both times the patient had right face numbness (felt like Novocaine) that started in her right cheek and spread to her lips and up into her eye and ultimately radiating throughout her head, and also swelling throat/ear canal on right side. It was unknown if treatment was received for the events. Clinical outcome of the events was not recovered.
56 2021-03-03 muscle twitching, bell's palsy Bell's Palsy; eye twitching; dizziness; This is a spontaneous report from contactable consumers (one... Read more
Bell's Palsy; eye twitching; dizziness; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200, expiry date not reported), via an unspecified route of administration at the right arm on 20Feb2021 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number: EL9265, expiry date: not reported) in the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization but experienced face numbness and swelling throat/ear canal on right side. It was reported that the second dose was even worse than the first time and involved continued eye twitching and significant dizziness. The patient had not sought medical attention yet, but if it continued to get worse, she would call her doctor or (helpline number). The patient reported that it almost feels like Bell's Palsy on an unspecified date. It was unknown if treatment was received for Bell's palsy. Clinical outcome of Bell's palsy was not recovered, while for eye twitching and dizziness was unknown.
56 2021-03-03 pain in extremity Extreme Body aches, extreme headaches, extreme chills, fever 105.2, pain in the arm, dizziness, nau... Read more
Extreme Body aches, extreme headaches, extreme chills, fever 105.2, pain in the arm, dizziness, nausea, fainted at 6 pm on 02/27/21,, no response or movement. Blood pressure dipped down to 60/42 ...Ambulance came. EMT measured the blood pressure... 60/42 Was taking Tylenol 2 tablets of 500 mg. (max out) Fever will go down for an hour but would be back with extreme chills. Symptoms Fever, chills, body aches persisted for 30+ hours.
56 2021-03-04 bell's palsy 4 days post vaccine I got Bells Palsy. Went to hospital for diagnosis on 5th day. Put on predniso... Read more
4 days post vaccine I got Bells Palsy. Went to hospital for diagnosis on 5th day. Put on prednisone and valtrex. Total paralysis on left side of face. Currently under the care of a neurologist, opthalmologist, acupuncture, massage and general practiioner. I tested COVID positive on 1/7 and 1/21. Tested negative on 1/28. Received vaccine 25 days after negative test.
56 2021-03-04 feeling hot Warmth in body
56 2021-03-04 pain in extremity Sore upper arm
56 2021-03-05 muscle twitching, muscle spasms Muscle Spasms, twitches around mouth, muscles feel tight
56 2021-03-06 breast pain Right breast tenderness/mild pain, starting approximately 18 hrs after vaccine, lasting approximat... Read more
Right breast tenderness/mild pain, starting approximately 18 hrs after vaccine, lasting approximately 48 hrs. Fatigue beginning approximately 3 hrs post vaccine, lasting approximately 48-72 hrs.
56 2021-03-06 feeling hot Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute wa... Read more
Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute waiting zone as she has had anaphylactic reactions in the past. At 2008 patient stated she felt hot. She had a rash developing on her neck, noted a dry mouth and thickening tongue. EMS brought in for evaluation. Blood pressure 204/102, pulse 65, oxygen 100% on 2L nasal cannula. 50 mg benadryl administered IM left deltoid 2011. 20g PIV started left antecubital, 125 mg administered. Ambulance on site. Patient able to speak clearly, verbalized the need to void her bladder. Patient accompanied by 2 RNs to the restroom. She was stable on her feet, escorted back to EMS stretcher. She was taken to hospital. VAERS submitted.
56 2021-03-06 numbness, tingling Tingling, numbness to right cheek and chin. Cleared by medics.
56 2021-03-07 feeling hot Extreme hot, sweating, rash and itching all over chest, neck, back, red and horrible itch on face a... Read more
Extreme hot, sweating, rash and itching all over chest, neck, back, red and horrible itch on face and head, out of breath, fast heartbeat, dizzy
56 2021-03-07 feeling hot patient received first Covid 19 vaccine, placed in observation after 15 minutes patient complained o... Read more
patient received first Covid 19 vaccine, placed in observation after 15 minutes patient complained of feeling dizzy and felt hot. Vital signs taken, BP- 118/70, HR- 88, Sats 99%, offered water accepted and consuming , patient observed for another 15 mins for total of 30 mins, voices that she feels better with dizziness and feeling hot now gone.
56 2021-03-07 numbness, facial paralysis Possible throat swelling, facial numbness/droop to the rights side. Vaccine administered in right ar... Read more
Possible throat swelling, facial numbness/droop to the rights side. Vaccine administered in right arm. Benadryl 50 mg administered to left arm IM, transport recommended but the family stated she would seek medical care and declined transportation.
56 2021-03-07 migraine Migraine that lasted 36 hours, 101.7 fever (not sure how long), chills, muscle and joint ache
56 2021-03-07 pain in extremity Headache; Tired; Arm soreness; This is a spontaneous report from a contactable consumer, the patient... Read more
Headache; Tired; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. This 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3247), dose 1, single dose via an unspecified route of administration in the left arm on 14Jan2021 at 20:30 for COVID-19 vaccination. There was no relevant medical history. There were no known drug allergies. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D), estradiol (VIVELLE) patch .05 estrogen only and famotidine (PEPCID). On 04Feb2021 at 12:00, the patient had headache, tired and arm soreness. No treatment was received for headache, tired and arm soreness. The clinical outcome of headache, tired and arm soreness was recovered.
56 2021-03-07 pain in extremity Immediately following injection felt fine with only minor soreness in arm. 24 hours post injection, ... Read more
Immediately following injection felt fine with only minor soreness in arm. 24 hours post injection, chills, fatigue, headache, neckache, backache, nausea, throbbing pain in arm. Symptoms persisted 5:00 PM through 3:00 PM following day. Symptoms kept me in bed unable to function.
56 2021-03-08 pain in extremity On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm... Read more
On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm my left eyes was bloodshot. Really, really red. I put some over the counter eye drops in both eyes on Tuesday night and Wed every 4 hours. Redness subsided 24 hours later, but eyes were still itchy. They Thursday night my left gland started swelling. On Friday it was very swollen. I could cup my hand around the swelling from check to neck. It hurt to swallow. I took my temperature every few hours and it was never elevated. It was always normal . I took an ibuprofen, 800 mg and just relaxed around 5:00 pm. Still swollen on Saturday, but going down, Took another 800. mg of ibuprofen Saturday night around 8:00 pm and swelling continues to go down, but still swollen as of Tuesday, March 9, my birthday. I did receive my Tetanus shot, preventative on February 15, 2021.
56 2021-03-08 throat numbness I had a headache and sudden lethargy. I ended up sleeping for 3 hours. Throughout that time, I wok... Read more
I had a headache and sudden lethargy. I ended up sleeping for 3 hours. Throughout that time, I woke up several times with 'cotton mouth' and a strange feeling that the back of my mouth, roof of my mouth and maybe a bit of my throat had a numb and tingly feeling. I drank quite a bit of water, but kept falling back to sleep. I can only compare it to when you receive novacane at the dentist but the sensation starts to goes beyond your mouth and a bit into your throat. This feeling stayed about the same for 3 hours and then over the next 3 hours started to dissipate. After that I just hand a mild lingering headache and general feeling of tiredness. By the next morning I just had a slight headache and physical feeling of tiredness.
56 2021-03-08 tenderness Pain and swelling at injection site. Nausea Muscle aches Earaches Joint pain Chills Tiredness Fatigu... Read more
Pain and swelling at injection site. Nausea Muscle aches Earaches Joint pain Chills Tiredness Fatigue
56 2021-03-09 discomfort Fatigued, heaviness to vaccination site, chills, low grade fever, chest pain, heaviness, pressure an... Read more
Fatigued, heaviness to vaccination site, chills, low grade fever, chest pain, heaviness, pressure and left upper arm pain that is still on as I am reporting this side effect today.
56 2021-03-09 flushing Pt had flushing and some sensation of throat closing.
56 2021-03-09 numbness NUMBNESS IN LEG, DIZZINESS
56 2021-03-09 muscle spasms 5 hours after first shot I began to feel the pain at the injection site but I also began to feel pai... Read more
5 hours after first shot I began to feel the pain at the injection site but I also began to feel pain in my lower back at the trunk of my spine. By the next day, March 4th I was in agony and could barely move. But Saturday morning the pain had not dissipated even with rounds of ADVIL and TYLENOL heat and ice packs. I went to the ER as given Tramadol, Naxoproxin, Cyclobenazprine and Lidocaine patches. I use these all weekend but I discontinued everything but the Lidocaine patches because I need to drive and function at work. The pain is still there as a constant ache but travels up my spine in the forms of spasms. I feel it is definitely at the trunk but more pain to the right side. I have an appoint with a Spinal Pain doctor for next week.
56 2021-03-09 tremor, numbness, tingling begin with numbness and tingling to thumb ,pointer and middle finger then numbness and tingle to bil... Read more
begin with numbness and tingling to thumb ,pointer and middle finger then numbness and tingle to bilateral body sides from cheeks to ankles, became dizzy though I would pass out, begin shaking then had some nausea, heart was racing. It felt like the tingling was surging through my body. made it to couch to lie down took 12.5 mg Benadrly ODT. some relief then after about 5 min begin again 911 called ambulance to Hospital
56 2021-03-09 tremor Immediately after vaccine administration, patient became dizzy and started to shake, become sweaty a... Read more
Immediately after vaccine administration, patient became dizzy and started to shake, become sweaty and short of breath.
56 2021-03-10 weakness, mild one side paralysis The patient received her vaccination and waited the 15 minutes and the post vaccinating associate wa... Read more
The patient received her vaccination and waited the 15 minutes and the post vaccinating associate was asked to sit with her as she was feeling weak and had a bad day. She felt better and went to leave and had difficulty walking due to weakness in her legs. We helped her to a chair, checked her BP and it was 194/106 pulse 96. No meds were given. She explained that her mother was set to the hospital today and was just upset. Her BP did not improve so we called paramedics. Paramedics reviewed her situation She refused to go to the hospital and was taken away by her father who was with her.
56 2021-03-10 burning sensation Severe facial burning , neck redness, 2 red spots around injection site that happened 30 minutes aft... Read more
Severe facial burning , neck redness, 2 red spots around injection site that happened 30 minutes after she left facility
56 2021-03-10 migraine The first vaccine my side effect was that my sinuses opened up. That could've been due to the anxie... Read more
The first vaccine my side effect was that my sinuses opened up. That could've been due to the anxiety and then relief of receiving the vaccination causing that effect. I had dry mouth and I was thirsty. The second vaccine EN 6201 I had a headache the next day. Throbbing headache. I read not to take Advil or anything right after. February 09= vaccine February 10=headache February 11= headache didn't go away. I took Advil in the evening. February 12=headache worsened. I took Advil in the afternoon. February 13=I woke up and couldn't see out of my left eye. There was a fog in central vision. About an hour later there was a strange aura. A tornado like tunnel in the central vision started and then shot out from the corner of my left eye. The aura lasted seconds and then the foggy center dissipated throughout the day. The headache throbbed and throbbed. I took Advil around the clock every four hours instead of just one a day. February 14= Full head-ache was gone but sinus throbbed above both eyes. February 16= Eye doctor visit. Know clue if the vaccine caused the ocular migraine or not. I've never had one before and it is super scary. My vision hasn't been clear since then and my dry stable MD turned into wet which I don't think has anything to do with the vaccine. Maybe the headache and the Ocular Migraine was caused by the vaccine. Who knows. I just thought I would report it in case other people have the same. Collecting data is a good thing.
56 2021-03-10 pain in extremity Sore arm 3/6/21 Bad headache, nausea, chills 3/8/21 Headache, body sore all over, slight fever , w... Read more
Sore arm 3/6/21 Bad headache, nausea, chills 3/8/21 Headache, body sore all over, slight fever , worn out. 3/9/21 Slight headache, worn out. 3/10/21
56 2021-03-10 tingling, tremor Progress NotesFamily Medicine Cosigned/8/2021 10:39 AM COVID VACCINE CLINIC a 56 y.o. female wh... Read more
Progress NotesFamily Medicine Cosigned/8/2021 10:39 AM COVID VACCINE CLINIC a 56 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience tingling/shaking, short of breath. She denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and respiratory distress. PMH: depression, takes Abilify and Cymbalta. GERD on Protonix. Lipitor for cholesterol. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills ("shaky") and shortness of breath Patient denies fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, wheezing, rash, hives, eczema, itching of skin, abdominal pain, muscle aches, joint pain, dizziness and headaches tingling in hands.: Previous Reactions: none Objective Vitals Vitals: 03/08/21 0833 03/08/21 0851 BP: 133/78 123/71 BP Location: Left arm Patient Position: Sitting Pulse: 95 81 SpO2: 99% 98% Blood Sugar 117 collected at 0839 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: intially hyperventilating but improved after removal of mask. Eupnea at discharge. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Comments: Hyperventilating upon arrival to bay. Mask taken off to assist with this along with instructions on deep breathing. Assessment/Plan Treatment included: water, snacks and pepcid Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Pt observed in the bay for approx. 15 minutes. Pt greatly improved with treatments above. Pt encouraged to eat 30 minutes prior to next vaccine. She reports that she is appreciative of her care today. F/up with pcp as needed.
56 2021-03-11 flushing, numbness, hot flush, pain in extremity, tremor 45 minutes after receiving the vaccine I felt like I was helping by getting my vaccine. After 45 min... Read more
45 minutes after receiving the vaccine I felt like I was helping by getting my vaccine. After 45 minutes I started to get weird symptoms. I started to have a hot flushing sensation in my left chest and became mentally dissociated from the situation. I felt separated from the conversation and tried to touch my hands together and couldn't feel them it was like a part of me. I was still trying to function for days and the feeling of being unable to think continued. I remember muscle weakness and dizziness. It was hard to focus. I had body tremors and some nausea and fatigue, headaches, body aches. The dissociation came and went and I felt really wobbly. I tried driving on day four and was unable to function in traffic. I started having abdominal pain which has lasted for five weeks. The flushing was still there in my chest and started to move up into my neck. Extreme dizziness on day 6 and I slept for much of the day, brain fog. I reached out to many doctors for help but no one had advice. I felt really scared and overwhelmed. Day 8 I had severe nausea and abdominal pain muscle pain in legs and dizziness. I thought I wasn't going to wake up after sleeping on many days. My muscles hurt so bad that I thought it wouldn't end. I had many days of day long headaches and the flushing sensation with shortness of breath. All of my symptoms continued with different levels of severity for five weeks. On the fifth week I had a few days that I thought I was not going to live. I had a band of pain and abdominal fluid that felt hard to touch. I had no appetite and I still had severe muscle pain. I was still disoriented and dizzy. Over this time I reached out through telehealth and several medical professional that had no advice. My symptoms seemed to lessen from the five week point with more periods of feeling more normal. I have only felt a little normal for three weeks.
56 2021-03-11 pain in extremity Sore arm for 3-4 days
56 2021-03-11 tingling, weakness Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I h... Read more
Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I had chills. Moved to the clinic area. While under observation, symptoms increased. Tongue was reported to be swelling on right side. In retrospect, believe this was lymph nodes.Administered 2 doses together of Benadryl. Oxygen level and blood pressure remained strong. Hands turned bright red and itched. Left at 2:30. Took Benadryl and Tylenol at 3:00. Rashes and itchy throat continued for 48 hours as well as chills and aches. Overall outcome, positive health returned. Lack of energy. Bit of brain fog still remain.
56 2021-03-12 weakness Nausea, weakness, severe body aches, very painful injection site
56 2021-03-12 burning sensation, discomfort I got my second Covid-19 dose on Thursday morning 3/11/2021 at 9:35 am. I was feeling uncomfortable ... Read more
I got my second Covid-19 dose on Thursday morning 3/11/2021 at 9:35 am. I was feeling uncomfortable in my left armpit since Friday 3/12/21 noon, but I only realized it was swollen when I went to take a shower around 8:00 pm. I'm feeling it swollen, burning and mild pain.
56 2021-03-12 discomfort, difficulty speaking Discomfort, soreness and pain in neck area, as well as change in voice. Internal sore throat.
56 2021-03-12 numbness, tingling Site: Pain at Injection Site-Medium, Additional Details: pins and needles numbness/ tingling that is... Read more
Site: Pain at Injection Site-Medium, Additional Details: pins and needles numbness/ tingling that is spreading up her arm
56 2021-03-12 pain in extremity, weakness About 2 hours after receiving the vaccine, I became very nauseated. I than begin vomiting. I vomit... Read more
About 2 hours after receiving the vaccine, I became very nauseated. I than begin vomiting. I vomited probably around 7-8 times (maybe more), and the last 2 times there was nothing left in my stomach to come up and I was just heaving. I also had moderately severe lower abdomen cramps (just above my pelvic bone). It felt like my insides were twisting at times, and the pain was constant cramping with moments of pretty severe twisting doubling over pain. I had chills just before the vomiting started, and felt like I had a slight fever, but because of the constant nausea/vomiting I did not take my temperature (all I have is an oral thermometer). To get the pain to stop, I had to lay down on a bed and put pressure on my stomach sides to ease the cramping. I tried taking Pepto-bismol to stop the nausea and vomiting, but immediately vomited that up too. The vomiting finally stopped after 2 times of dry heaving and nothing left to come up. The severe lower abdomen stomach cramping calmed down around 1 or 2 am. Today I feel weak, my right arm is very sore and slightly swollen, and as of the time of this report at 2:30pm I have only eaten some saltine crackers today. My stomach still feels weak, even though the nausea, cramping, and vomiting have gone away now.
56 2021-03-12 pain in extremity Low grade fever, exhaustion, arm pain started approximately 20 hours post administration Mild ches... Read more
Low grade fever, exhaustion, arm pain started approximately 20 hours post administration Mild chest pains 10 min post injection
56 2021-03-13 muscle spasms started out as feeling kind of like I was getting sick. It progressed to feeling achy, low grade fe... Read more
started out as feeling kind of like I was getting sick. It progressed to feeling achy, low grade fever and overall feeling bad. As the evening progressed so did the intensity and I began to have chills and my whole body hurt. I would have almost like a spasm throughout my body that happened a few times. I could not move without it hurting or feeling awful. The chills and fever finally broke early the morning of 03/14/2021. I had a confirmed case COVID in December of 2020. I never felt like this when I actually had COVID.
56 2021-03-13 pain in extremity, paralysis, burning sensation Pain and paralysis in all 4 extremities. Burning and stabbing sensation, bulging veins in hand. W... Read more
Pain and paralysis in all 4 extremities. Burning and stabbing sensation, bulging veins in hand. Was hospitalized from 2/28 until 3/5. Left hospital with no diagnosis and no real relief
56 2021-03-13 pain in extremity Left Under arm swollen and pain, some pain in arm
56 2021-03-14 feeling jittery, feeling hot PATIENT RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE. AT APPROXIMATELY MINUTE 15 POST VACCINATION ... Read more
PATIENT RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE. AT APPROXIMATELY MINUTE 15 POST VACCINATION PATIENT STATED THAT SHE WAS HOT AND FELT JITTERY. PATIENT WAS GIVEN WATER AND A BANANA AND HAD SEVERAL COUGHING SPELLS, SAID THAT SHE FELT A LOT OF MUCUS IN HER THROAT AND THAT SHE WAS ASTHMATIC. PATIENT HAD RESCUE INHALER WITH HER BUT NEVER USED IT. PATIENT REPORTED FEELINGS OF ITCHINESS AND WAS OFFERED BENADRYL BY RPH. PATIENT TOOK BENADRYL FROM EMERGENCY SUPPLY KIT. AFTER MINUTE 45 PATIENT WAS FEELING BETTER AND WAS RELEASED FROM OUR CARE.
56 2021-03-14 hot flush, unresponsive to stimuli annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonre... Read more
annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient) A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318 at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic. Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020. There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows: On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020. She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped. She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100 on 20Feb2021 , blood pressure measurement: 167/102 on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.
56 2021-03-14 muscle spasms After being in menopause since 2013 trigger menstrual cycle. Cramps and bleeding
56 2021-03-14 tingling, pain in extremity having pain and tingling in my right thigh; having pain and tingling in my right thigh; pain in my b... Read more
having pain and tingling in my right thigh; having pain and tingling in my right thigh; pain in my back; I can barely walk.; leg is weak; her arm was hurting; pinched nerve; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL9267) on 19Feb2021 10:00 at single dose for COVID-19 immunisation. Medical history included pain, tingling in right thigh, pain in back, patient can barely walk (she had this problem 10 years prior and haven't had these symptoms until she got the covid vaccine). Concomitant medications were none. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247) on 25Jan2021 for COVID-19 immunisation (Her first dose 25Jan2021. She sees UA-DOD. It has a little piece of paper on top that has lot number EL3247 for the first dose). Patient reported that she got the second Pfizer covid vaccine last Friday at 10am (19Feb2021 10:00). On Sunday (21Feb2021) she started having pain and tingling in her right thigh (21Feb2021), and patient experienced pain in her back (Feb2021). She can barely walk (Feb2021). She worked in a school. Everyone here had their second shot and everyone was fine except her. She had this problem 10 years prior and haven't had these symptoms until she got the covid vaccine. She spoke with the nurse here at the school and she said that this couldn't be related to the vaccine. Patient asked if this could be associated with the vaccine. In addition, patient reported that she got the shot, the second vaccine and she was doing fine the first day and Saturday and then Sunday (21Feb2021) she went walking, hiking and the only thing she had as far as reaction was her arm was hurting (Feb2021). On Sunday she started having a lot of pain in her right leg and it was tingling (21Feb2021), she thought the next morning she thought her body was having a reaction, it was weird she couldn't walk, her leg is weak and it bothers her, her thigh is hurting. She didn't have this problem before she got the vaccine, she does not know if it has to do with it. She is at work and every time she tells people about what is happening, she does not know if they have had a reaction but she knows that they told her you can have headaches, body ache, fever, that is what they told her but all she got is that tingling in the right thigh and it is bothering her, she can't walk and she is at work and can't even walk. She doesn't know what to do if she should see a doctor, she does not know if it has to do with the vaccine. She is confused she feels like she is crazy because she kept telling what is going on and people say it is everything else like stress but she did not have this before how come it is happening now. She asks does she need to go see her doctor now. She got the second dose Friday at 10 am, she confirms 19Feb. Sunday night she felt tingling and hurting and it was bothering her and she didn't think it was the vaccine but it got worse the next day and right now she is in a lot of pain she doesn't know if it is related. She confirms it started Sunday 21Feb2021 and it is ongoing. She says it has not gotten better she would say it has stayed about the same overall. She says she had this problem with something with her back. She thinks it had to do with her back about 10 years ago and it has come back. She is really surprised that it came back she got the vaccine and it came back 3 days after she got the vaccine. She does not know if this was a reaction but this pain thing and back thing she thinks she has a pinched nerve but she didn't have it for 10 years vaccine and now she has had a reaction. She does not know if that has to do with it or not. She has been fine all this time, no problems and now her back and the side of her thigh are hurting. The outcome of events having pain and tingling in my right thigh was not recovered. The outcome of other events was unknown.
56 2021-03-15 flushing flushing on upper torso and face, hives on lips, tingling of tongue, throat itching , bloating and g... Read more
flushing on upper torso and face, hives on lips, tingling of tongue, throat itching , bloating and gas approximately 35 to 40 minutes after injection. Self dosed with Benadryl, alerted my physician
56 2021-03-15 muscle spasms, muscle twitching Pain, muscle ache and spasm down entire left arm. All day. Continued into 2nd day (3/16). Forearm & ... Read more
Pain, muscle ache and spasm down entire left arm. All day. Continued into 2nd day (3/16). Forearm & fingers twitching nonstop.
56 2021-03-15 pain in extremity Itching started in feet immediately after shot. Weird pain in lower middle back. Itching progresse... Read more
Itching started in feet immediately after shot. Weird pain in lower middle back. Itching progressed to entire body after about an hour. Took 12.5 mg Benadryl, then took 12.5 mg two hours later. Next day arm was swollen and aching, itching continued. Took 625 mg Tylenol Arthritis, 25 mg. Hydroxyzine every 8 hours for two days.
56 2021-03-15 pain in extremity pain in R arm/bicep swollen lymph nodes over right clavicle, with redness and pain on palpation
56 2021-03-15 pain in extremity 3-11-21 9AM HAD 'CHEST PAIN, SOB, SORE ARM, MUSCLE ACHES AND FEVER'. 'LUNGS ALSO HURT/PAINFUL TO BR... Read more
3-11-21 9AM HAD 'CHEST PAIN, SOB, SORE ARM, MUSCLE ACHES AND FEVER'. 'LUNGS ALSO HURT/PAINFUL TO BREATHE IN'. 3-15-21 11:20AM PT STATES 'FEELS BETTER NOW'. ADVISED TO CALL HEART DR R/T DOSE#2.
56 2021-03-15 pain in extremity Moderate fatigue, metallic taste in mouth, burning sensation in nose, muscle aches, bilateral ankle ... Read more
Moderate fatigue, metallic taste in mouth, burning sensation in nose, muscle aches, bilateral ankle and knee soreness, headache, very sore left arm, flu-like -ache in nipples Arm soreness declined over two weeks, ankle and knee soreness currently persist, fatigue lasted one week, other symptoms stopped after third or fourth day Treatment was acetaminophen, increased water intake and rest
56 2021-03-15 pain in extremity Sore arm, Sluggish and fatigue for about 30 hours
56 2021-03-15 pain in extremity Sharp pain in upper arm that feels like I am being stabbed. It radiates from my shoulder to my elbow... Read more
Sharp pain in upper arm that feels like I am being stabbed. It radiates from my shoulder to my elbow. I do not have a complete range of motion moving my arm at the shoulder and cannot reach my arm behind my back. Ice has been applied 3x per day since the injection and ibuprofen does not help.
56 2021-03-15 tingling, numbness and pain in extremities, pain in extremity Ulnar neuropathy - pain and tingling in left elbow to pinky and ring finger Prednisone Ortho appoi... Read more
Ulnar neuropathy - pain and tingling in left elbow to pinky and ring finger Prednisone Ortho appointment scheduled
56 2021-03-15 cold extremities, weakness, pain in extremity 2/22/2021 1st Dose: Within 2 hours: severe pain from neck to fingertips on L arm. Lasted approximate... Read more
2/22/2021 1st Dose: Within 2 hours: severe pain from neck to fingertips on L arm. Lasted approximately 4 days. Within 4 hours: severe headache, took 2 500mg Tylenol about 3-4 times over the course of 48 hours. Headache subsided on 3rd day. 3/15/2021 2nd Dose: Within 1 hour: weakness, pain from neck thru fingertips in L arm, throat swelling, came home took 2 Tylenol 500mg gel caps at 4:00pm. Napped until 7:00pm. Temperature was 97.5. Thought I was feeling better. Went to bed at 11:00pm. By 2:30am I was awaking, restless sleep, pain all over body, every joint. Finally got out of bed at 11:30am today. Nerves and joints feel as tho on fire. Both arms and hands very swollen. Toes swollen. Nauseous. No appetite. Hurts to move, sit or lay down. Have rested all day. 6:40pm temperature is 99.8. Feel awful. Shooting pain like electricity down both arms into hands extremely sensitive to cold - feels like fire.
56 2021-03-15 tenderness Severe lower abdominal/pelvic pain located in the center and left side. Very tender. Pain came and w... Read more
Severe lower abdominal/pelvic pain located in the center and left side. Very tender. Pain came and went for several days. Went to the emergency room Thursday (3/10/21) due to increasing pain. Tried Tylenol, tums and Gas-X during this time without and alleviating of symptoms. Pain & tenderness slowly decreased over the course of a week.
56 2021-03-16 breast pain Never been pregnant I received the injection in my right arm. On the next day around 12 pm, I began ... Read more
Never been pregnant I received the injection in my right arm. On the next day around 12 pm, I began to feel a dull ache in the left breast. The pain grew sharper and deeper to the point where I could not lift my left arm, it was that painful making it hard to sleep. The next day the pain started diminishing. On the 3rd day after the vaccine, the pain had mostly resolved.
56 2021-03-16 pain in extremity Fatigue and very sore arm the following day
56 2021-03-17 breast pain Chills and tiredness on 3/14/2021. Injection site pain from 3/14-3/17. Sore breasts from 3/15-3/17. ... Read more
Chills and tiredness on 3/14/2021. Injection site pain from 3/14-3/17. Sore breasts from 3/15-3/17. No treatment. Outcome - resolved.
56 2021-03-17 discomfort Chills began 11 hours after shot and continued for 4 hours. Mild fever ( 99.5) began 11 hours after ... Read more
Chills began 11 hours after shot and continued for 4 hours. Mild fever ( 99.5) began 11 hours after shot and continued on and off until 60 hours after the shot. All over body aches and skin sensitivity began 11 hours after the shot and continued for 36 hours and then resolved. Swollen lymph node at left armpit began 11 hours after the shot and was/is uncomfortable and at times painful. Initially the swelling was very pronounced and interfered with arm movement. The swelling has diminished a bit now (75 hours after the shot), but there is still some swelling and occasional pain.
56 2021-03-17 numbness, facial paralysis Fevers x 24 hours, Aches x24 hours, Wheezing X 24 hours Drooped face and numbness x few days.
56 2021-03-17 pain in extremity Very sleepy, as if i had anesthesia. My arm hurts, I can't touch it, and it hurts to move it.
56 2021-03-17 pain in extremity Sore arm day of vaccine: vaccine at 10:15, sore arm starting at 8 pm and still is sore at 11 pm the... Read more
Sore arm day of vaccine: vaccine at 10:15, sore arm starting at 8 pm and still is sore at 11 pm the next day: headache upon waking the day after vaccine: only lasted a few hours. Runny nose the evening after the vaccine on the 18th.
56 2021-03-17 tingling, numbness About 3 days after the vaccine I started feeling arm pain (right below the shoulder, not exactly at ... Read more
About 3 days after the vaccine I started feeling arm pain (right below the shoulder, not exactly at the injection site, a little back), in the evening, around suppertime. In the morning it got much worse. I had a little trip the next morning (3 hours each way) and when I returned home the pain was really severe. Used Ibuprofen at home and it solved the problem at first (for the weekend), it would take off that edge. But by Tuesday, I noticed that it was not getting any better just would ease off while taking Tylenol and Ibuprofen. Decided to go see my PCP. Initially PCP thought it was a case of tendinitis and was treated with Voltaren and Tramadol for night time in case it was too hard to sleep. Took Voltaren for a couple of days but did not see any real improvement so decided to go back to the Ibuprofen. The next Monday or Tuesday (about a week later) it was really really bad, and PCP gave me a shot of cortisone into that shoulder because at that time I was feelings numbness on my fingers and horrible pain in the shoulder. About 48/72hrs after the shot the pain subsided but the numbness and the tingling on my pointer finger and thumb were still present. The pain went away in about a week. Then PCP decided to refer me to see a neurologist. By the time I had my appt the numbness and tingling were much better and I had some tests done and they came back normal. Never lost strength in my arm. Neurologist said the numbness and tingling should go away on its own. Now, 2 months later he numbness and tingling are really mild, I am a stomach sleeper and I can't because if I do it will make my arm tingling again. Nowadays I feel it maybe once or twice a day an not extreme.
56 2021-03-18 difficulty speaking Throat tightness, hoarseness, cough shortly after administration
56 2021-03-18 flushing 30 minutes after receiving the COVID 19 vaccine, the patient experienced an allergic reaction with f... Read more
30 minutes after receiving the COVID 19 vaccine, the patient experienced an allergic reaction with facial and tongue swelling and difficulty swallowing. A rapid response was called and the patient was taken to the emergency department where she had an IV placed and received IV famotidine, IV diphenhydramine, IV methylprednisone, a NS bolus, and epinephrine. Patient was then monitored in the ED. Patient has plans to discharge from the ED to home. COVID vaccine was placed as an allergy in the patient chart.
56 2021-03-18 muscle spasms, flushing Within 5 minutes, burning and swelling in throat, cramps and diarrhea, flushing and hot neck and fac... Read more
Within 5 minutes, burning and swelling in throat, cramps and diarrhea, flushing and hot neck and face, rash on chin and face. Responded to Benadryl and Ventolin.
56 2021-03-18 pain in extremity The first day about 4 hours after shot my arm started hurting and steadily got so i could not lift i... Read more
The first day about 4 hours after shot my arm started hurting and steadily got so i could not lift it more than 1/3 up. My neck hurt. by Tuesday my neck and back hurt so bad I had a hard time talking and raising my head all the way. I had to take more of my prescribed pain med and prednisone to control the pain. The pain/burning is now all the way down my neck/spine around my right rib and into my arms and mostly right leg. I called my doctors and she called in a medrol dose pack which i will pick up today. I also started having a bad headache Thursday. I may have to go to urgent care if I can't control the pain.
56 2021-03-18 pain in extremity It's only pain in my arm. Quite severe in the beginning. Right now it is easing. Just thought it wou... Read more
It's only pain in my arm. Quite severe in the beginning. Right now it is easing. Just thought it would be good for you to know for statistics.
56 2021-03-19 weakness, discomfort Extreme dizziness with weakness and nausea started about an hour after I got home. I felt so ill I d... Read more
Extreme dizziness with weakness and nausea started about an hour after I got home. I felt so ill I did not think to call the doctor or go to the doctor's office since I was home alone. I laid down on the floor for awhile before managing to get to the bedroom. I stayed in bed for several hours before attempting to get up; the symptoms were not as severe but still felt weak and dizzy when standing. Today symptoms have improved but still feel uncomfortable.
56 2021-03-19 pain in extremity 5 minutes after the shot my heart began to beat very hard and very fast. It lasted about 5 minutes. ... Read more
5 minutes after the shot my heart began to beat very hard and very fast. It lasted about 5 minutes. For the remainder of the day into the evening I had heart palpitations. The following day I felt tired and nauseous until around 11am. My arm is sore and itchy.
56 2021-03-19 pain in extremity Fever chills pain in arm severe headache body aches slight nausea fatigue. Almost 48 hours and stil... Read more
Fever chills pain in arm severe headache body aches slight nausea fatigue. Almost 48 hours and still have headache arm pain nausea. I believe after 36 hours the fever left.
56 2021-03-20 feeling hot Three days after injection, there was a sudden onset of hives over much of my body, accompanied by a... Read more
Three days after injection, there was a sudden onset of hives over much of my body, accompanied by an intense feeling of heat. Affected areas were face, neck, arms, hands, and knees. I took one Benadryl and went to bed. The next morning, most visible signs of the rash are gone, with a slight itchiness remaining.
56 2021-03-20 numbness Swollen tongue, diarrhea, throat closing, numb tongue, numbness on left cheek on face.
56 2021-03-20 pain in extremity I had my first shot around 10 am and my left arm was very sore and got progressively worse. I playe... Read more
I had my first shot around 10 am and my left arm was very sore and got progressively worse. I played golf the next day (Tuesday) and I woke up in the middle of the night with nagging shoulder and chest pain. I was concerned it was heart related. It continued for 2 weeks off and on but fairly intense at times. Not sure if I slept on it funny. When to my primary care dr and had an X-ray and ekg. Both came back negative. I am still having chest pain so I am calling again 3/22 to discuss with dr.
56 2021-03-20 pain in extremity Sore arm, Body aches, chills
56 2021-03-20 tingling Pins and needles feeling in my feet, legs, hands and arms. Started out off and on, but is now almost... Read more
Pins and needles feeling in my feet, legs, hands and arms. Started out off and on, but is now almost constant. It's been 13 days since I was vaccinated and is not going away yet. Very prevalent shaky, buzzy type feeling. I am concerned about getting the second vaccine. Do I still get it? It is scheduled for Apr 1st. Hopefully this will have subsided by then. If not, and I don't get the second dose, am I still protected against Covid?
56 2021-03-21 throat numbness on 3/4 went to ED w/ numbness in throat and rib cage pain. Treated with prednisone, hydroxyzine/ at... Read more
on 3/4 went to ED w/ numbness in throat and rib cage pain. Treated with prednisone, hydroxyzine/ atarax and discharged home
56 2021-03-21 tremor, flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mil... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
56 2021-03-22 burning sensation Two days after vaccine - I break out in a rash on my arms, legs, back, neck. It is a allergic react... Read more
Two days after vaccine - I break out in a rash on my arms, legs, back, neck. It is a allergic reaction rash. It has lasted four days and still going. Very itchy and burning. Red welts. Have been taking Bendryl and Zytrtec
56 2021-03-22 feeling hot, tremor, numbness About 15-17 minutes after the shot I was driving home and all of a sudden felt hot, my heart started... Read more
About 15-17 minutes after the shot I was driving home and all of a sudden felt hot, my heart started racing, my hands started shaking, and I felt dizzy and lightheaded and my hands also felt numb. The worst of it probaby only lasted 5 minutes. I felt well enough to drive home but was still lighthead and shaky for about 45 minutes. An hour later, I feel ok except for a little lightheadedness.
56 2021-03-22 flushing Pt felt flush after Covid shot.
56 2021-03-22 pain in extremity, tenderness As soon as I received the second dose of the vaccine my left arm started to hurt a lot. The pain was... Read more
As soon as I received the second dose of the vaccine my left arm started to hurt a lot. The pain was increasing to a point where I was not able to hold anything with my left arm. It felt like someone was punching me in the arm, or a had a needle in there, throbbing in the left shoulder. The pain and tenderness in the front of my arms continue. This pain continues,. I went to see an specialist on 03/22/2021, and he said a have Impingement syndrome of left shoulder from the covid vaccine. On 03/23/2021 Md prescribed me DEPO-MEDROL INJ 40 mg and Physical Therapy
56 2021-03-23 weakness 3/22/2021 at 12:00 p.m. Intense headache relieved somewhat with Tylenol. Ended around midnight on 3... Read more
3/22/2021 at 12:00 p.m. Intense headache relieved somewhat with Tylenol. Ended around midnight on 3/23/2021. 3/22/2021 at 1:00 p.m. mild diarrhea which lasted until 3/23/2021 7:00 a.m. 3/23/2021 1:00 p.m. overall weakness and fatigue. Resolved 3/24/201 at 7:00 a.m. 3/22/20221 7:00 p.m. left arm pain at injection site. Almost completely resolved 3/24/2021 at 7:00 a.m.
56 2021-03-23 difficulty speaking, slurring Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue s... Read more
Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue swollen, slurred speech, dysphonia. Was given benadryl, epipen and decadron transferred to ER where she was given additional benadryl and solumedrol and observed. Pt discharged from ER after period of observation.
56 2021-03-23 feeling hot Progress Notes Healthcare Provider Cosign Needed Expand AllCollapse All Subjective Patient is... Read more
Progress Notes Healthcare Provider Cosign Needed Expand AllCollapse All Subjective Patient is a 56 y.o. female who was seen at healthcare facility today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience dizziness and hot. Patient has a history of multiple sclerosis and complained of a weakness in her legs that she experiences during her flares. She does mention having to be on 2L oxygen at times when she has a flare. O2 is 100% at rest today. She denied rash, difficulty breathing, difficulty swallowing, throat tightness and facial swelling. This provider was notified of patient reaction and she was then assessed. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and increased weakness. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing and headaches Previous Reactions: Denies reactions to prior vaccines Objective Vitals Vitals: 03/24/21 1202 03/24/21 1219 03/24/21 1232 BP: (!) 155/92 (!) 145/78 136/76 Pulse: 86 79 80 SpO2: 100% 100% 100% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling of lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: Water and lying patient in trendelenburg position. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash)
56 2021-03-23 numbness Patient experienced numbness in lower right side of face about 12:15PM after receiving second Covid ... Read more
Patient experienced numbness in lower right side of face about 12:15PM after receiving second Covid vaccine dose 3/24/21. Patient went to MD and doctor determined patient had no motor deficits.
56 2021-03-23 pain in extremity Swollen & sore arm for 4 days. Gas for 18-20 hrs. Nausea for 2 wks. Headache on left side is still o... Read more
Swollen & sore arm for 4 days. Gas for 18-20 hrs. Nausea for 2 wks. Headache on left side is still occurring.
56 2021-03-23 pain in extremity Sore arm Headache Drowsiness Upset stomach Body aches
56 2021-03-23 tingling, feeling cold Within 5-7 minutes of getting the vaccine, I felt a cold sensation in my brain followed by a tingly ... Read more
Within 5-7 minutes of getting the vaccine, I felt a cold sensation in my brain followed by a tingly sensation in my face, sick on my stomach, dizziness and feeling faint. My husband told me to lean by in my chair, and I did. For a minute or two I felt slightly better, but then it started again; my stomach hurt, I felt dizzy and felt like I was going to faint. My husband got out of the car and went to get the paramedics. When they arrived, they asked me if I could walk to the tent. I knew I had to because I knew I was in trouble. When I got to the tent, I sat down and told the paramedics I was going to faint, and I did. When I regained consciousness, I threw up twice. The paramedics put a heart monitor on me, (from what my husband told me) they took my blood sugar, (I heard the paramedic say the result, and I told him I was not a diabetic). They put an IV in me, and gave me fluids, (from what my husband told me). They sent me by ambulance to ER. In the ED, I told the doctor what happened. She said what happened were not the side effects of the vaccine. After lying supine for sometime, I started to feel the same symptoms again; sick on my stomach, dizziness and feeling like I'm going to faint. I called out for someone. When the doctor came in, I told her I was starting feel the same way as before. She said my labs were great, and they were ready to discharge me; but I could stay if I wasn't ready to go. I told her I trusted her judgement, and was discharged. Throughout the day, I had the same symptoms, but did not faint again.
56 2021-03-23 tingling Uticaria rash to left arm and face which occurred 9 days after vaccine. Itching and picking discomf... Read more
Uticaria rash to left arm and face which occurred 9 days after vaccine. Itching and picking discomfort to rash . On antihistamine twice a day, hydrocortisone cream to face and triamcinolone cream to arm. Hydroxyzine for itching. At this time the rash continues . Note my father (different home) had the same reaction with biopsy of rash to confirm and 2 months later is still battling the rash.
56 2021-03-23 tremor about a minute after injection, started shaking, sweating, got very light headed with the feeling I ... Read more
about a minute after injection, started shaking, sweating, got very light headed with the feeling I might pass out. Chest got very tight and breathing was strained. Waited with a pharmacy tech, drank water, called husband to come pick me up. Blood pressure went to 178/110, heart rate up to 154 before it subsided. Was able to leave after 45 minutes. Took Benadryl for the next 48 hours to stop reaction. Had waves of the same symptoms several times a day for 4 days after injection.
56 2021-03-23 tremor Patient 56 y.o. year old Date of incident: 03/24/21 Time of incident: 1013 am Location of ... Read more
Patient 56 y.o. year old Date of incident: 03/24/21 Time of incident: 1013 am Location of incident: vaccine hub triage area Pertinent patient history: History of severe anaphylactic reaction to gabapentin in 2018. Patient had discussed with PCP and allergist who agreed that patient should receive her COVID-19 vaccine. Description of incident: Patient was brought back to the triage area for vaccinator to administer the vaccine near emergency equipment and patient had her own epi pen with her (this was not used). Patient agreed and consented to receive the COVID-19 vaccine. Patient received the COVID-19 vaccine at 1013. At 1023 patient started feeling "off" BP was 177/105, pulse 96 and oxygen 97% Dr. was notified and was present in the triage area and 1st dose of epinephrine was administered in patients right thigh. Patient was coughing and feeling like her throat was closing. Patients BP at 10:25 was 197/109 and 10:26 pulse ox 95% and pulse 64. Patient continued to cough and experience shakiness and unable to catch her breath oxygen was applied at 6 L/minute per VORB from Dr. Patient received 2nd dose of epinephrine at 1026 per VORB from Dr. Patient received 125 mg of IM solumedrol in left deltoid VORB from Dr. at 1032. No benadryl was given due to allergies. EMS arrived at 1035 and administered a 3rd dose of epinephrine. IV started by EMS. EMS transported patient to ED. Patients wife was present during event and drove to meet patient at ED. Orders initiated per RN protocol: EpiPen administered per protocol Additional verbal order for 6 L oxygen by nasal cannula, 2nd dose of epinephrine & 125 mg of solumedrol given by Dr. - read back by RN Patient outcome: Transported via EMS to ED Patient left vaccine clinic via Patient Transport: Ambulance: EMS Called at 1023 arrived at approximately 1033. Other notes: Other RN's involved in this event were RN, RN, RN, Dr., and Dr. RN .................... 3/24/2021 11:04 AM
56 2021-03-24 flushing Flushing/itching. BP 147/104 (pulse 85), 97% O2 sat. Final BP 133/96 (pulse 78), 96% O2 sat. Benadry... Read more
Flushing/itching. BP 147/104 (pulse 85), 97% O2 sat. Final BP 133/96 (pulse 78), 96% O2 sat. Benadryl 25 mg PO given.
56 2021-03-24 numbness, pain in extremity, tingling Severe arm pain all night. Woke up around midnight with my entire left arm and hand numb and tingli... Read more
Severe arm pain all night. Woke up around midnight with my entire left arm and hand numb and tingling like it had fallen asleep but I was not laying on it. I moved it around until it finally stopped. Pain continued all not. On 3/24/21 was very tired and foggy. On 3/25/21 have a headache and slight nausea. I had an ophthalmic event where I saw lighting flashes in my right eye so it could be this causing instead of the vaccine. I am fine just thought I should report these occurred. Thanks!
56 2021-03-24 muscle spasms, pain in extremity Woke up at 3am with shooting pains in my arm back and neck. Had a bad headache and was nauseous. I ... Read more
Woke up at 3am with shooting pains in my arm back and neck. Had a bad headache and was nauseous. I got up and took a Tylenol, went back to bed and woke up 2 hrs. later with the same side effects. I could not eat, tried to drink as much as possible and continued to have extreme cramping all over my body as well as chills, sweats, nausea and light headedness. I did not run a fever, but was unable to get off the couch and do normal activities until the next morning. I continued to take Tylenol for 3 days but had a low grade headache and backache for a number of days. I have not been this sick for years. Glad the severity only lasted a day and a half. Im still struggling with back pain 3 days later.
56 2021-03-24 pain in extremity, burning sensation, feeling hot Very sharp shooting pain from left clavicle to left TMJ, tachycardia, left ear hot, burning sensatio... Read more
Very sharp shooting pain from left clavicle to left TMJ, tachycardia, left ear hot, burning sensation, chest tightness, pain radiating into left arm and left leg. Tx: diphenhydramine 50 mg orally every 10 min until symptoms lessened/resolved. Aprox 300 mg over 30 min All symptoms resolved within 60 min
56 2021-03-24 pain in extremity At time of the shot, just a sore arm for about a day. Then fine for a week. One week later the inj... Read more
At time of the shot, just a sore arm for about a day. Then fine for a week. One week later the injection site started to itch. By the 8th day, there was a red itchy rash at injection site.
56 2021-03-24 tingling 03/19/2021 1055, 5-6 min she started having pain, tingling in her face then pass out. When she wok... Read more
03/19/2021 1055, 5-6 min she started having pain, tingling in her face then pass out. When she woke she was c/o upset stomach and vomited twice. Was brought to hospital and stayed for 3 h0ours. Headache is still
56 2021-03-24 tingling Patient stated they experienced left arm tingling following receiving the vaccine. Client was evalu... Read more
Patient stated they experienced left arm tingling following receiving the vaccine. Client was evaluated by onsite Fire Rescue. Client was released to go home at 12:33 pm . Per Fire Rescue no additional evaluation needed.
56 2021-03-24 seizure Pt received 2nd dose vaccine, waited her 15 minutes and upon leaving was witnessed by PD to have slu... Read more
Pt received 2nd dose vaccine, waited her 15 minutes and upon leaving was witnessed by PD to have slumped on the floor, without trauma and began to seize. EMS called to scene and medical OIC called. Upon arrival, 911 called, SpO2 placed. VSS and respirations adequate. Negative for emesis. After 2 seizures, the patient regained consciousness and was able to communicate that her husband was outside, his name was in a blue vehicle. She confirmed she had a history of seizures. Her husband informed us she has a history of these seizures and brain CA. EMS arrived and took control of patient and transported to hospital.
56 2021-03-24 tenderness 1. Mild headache 2. Moderate itchiness all over (I am on my 4th round of antihistamine) 3. On the l... Read more
1. Mild headache 2. Moderate itchiness all over (I am on my 4th round of antihistamine) 3. On the location of the shot (left upper arm) muscles are very tender. It hurts when I put pressure. Unable to sleeping on my left side. 4. Mild stomach pain - typical feeling when I am having an allergic reaction.
56 2021-03-24 tremor dehydrated; shaking; bowel movement that was loose but not like it was, not diarrhea; she had a litt... Read more
dehydrated; shaking; bowel movement that was loose but not like it was, not diarrhea; she had a little bit of something in her bladder, in her urine; she had a little bit of something in her bladder, in her urine; woke up completely drenched; Blood pressure dropped; Vomiting; nauseated and couldn't eat; nauseated and couldn't eat; high fever/ It got to over 103; Diarrhea is like a greenish color; diarrhea; Chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 56-years-old, administered in Arm Right on 03Mar2021 15:00 (Lot Number: EN6204; Expiration Date: 30Jun2021) as single dose for COVID-19 immunization. Medical history included kidney and pancreas transplant patient since 01Apr2014 (On 01Apr2021, will be seven years since her transplant), Gastroparesis from 2005, Small intestinal bacterial overgrowth from 2019 (hasn't had any issues with that in over a year), Diabetic macular edema (Doesn't think Diabetic macular edema pertains to anything with the COVID Vaccine), pacemaker in her stomach (Procedure for pacemaker for stomach performed first time in 2006. Stomach pacemakers only last eight to ten years. Had the battery replaced in 2017), she had previously had C-Diff, high blood pressure (Doesn't have high blood pressure anymore), immunosuppressed. The patient's concomitant medications were not reported. Patient states about a week ago, she talked to someone at clinic, reporting after she got the first dose of the Pfizer COVID 19 vaccine. She had reported she had diarrhea. Clarifies she got her vaccine on 03Mar2021 at 15:00PM in the right arm. She previously reported she started having diarrhea in the night, Thursday (04Mar2021), and had it for ten days. At that time, when she had reported, she only had diarrhea. Diarrhea is like a greenish color. Has been trying not to eat heavy things, but diarrhea is still a greenish color. She contacted her stomach doctor and he wanted her to do a COVID 19 test, which was negative; and a whole stool work up because she had previously had C-Diff. She did all that and turned it in Friday. Adds she did have the chills a little on the day of the vaccine but they went away. Reporting new events today including on 13Mar2021 she started having a fever. It got to over 103; she was so nauseated she couldn't eat (13Mar2021); with chills (03Mar2021) and shaking (unspecified date). She treated the fever with Tylenol and got some relief but then her fever would go back up. She thinks she was getting dehydrated (Mar2021) from all the diarrhea and then she started to throw up on Tuesday (16Mar2021). That day she was admitted to the hospital, 16Mar2021. At the hospital they did another COVID 19 test that was negative; blood tests; urine test; US kidney; CAT Scan whole stomach; and they could not find anything that could cause her symptoms. Adds they did say she had a little bit of something in her bladder, in her urine (unspecified date). While hospitalized she was treated with IV antibiotics; Phenergan and Zofran which controlled the nausea and vomiting. Her fever went down to 99 by Friday. Adds she did have one episode on Friday of low blood pressure (19Mar2021) and they were watching it. She was discharged on Saturday and has not had a fever since she came home. Adds she did have a bowel movement that was loose but not like it was, not diarrhea (unspecified date). Mentions for the last two nights she woke up completely drenched (20Mar2021) but she did not have a fever. Adds she felt a little chill last night, but she just covered up with her blanket. She feels her dehydration is improving. Therapeutic measures were taken as a result of dehydrated, high fever/ it got to over 103 (pyrexia), vomiting, nauseated and couldn't eat. The outcome of dehydrated was recovering, diarrhea and diarrhea is like a greenish color was recovered on 18Mar2021, high fever/ it got to over 103 was recovered on 19Mar2021, chills was not recovered, vomiting recovered on 17Mar2021, nauseated and couldn't eat recovered on 18Mar2021, blood pressure dropped recovered on 19Mar2021, woke up completely drenched was not recovered, and all other events was unknown. The patient was hospitalized for dehydrated from 16Mar2021 to 20Mar2021.
56 2021-03-25 numbness Patient reports numbing of arm the day after injection. She is also reporting shortness of breath (s... Read more
Patient reports numbing of arm the day after injection. She is also reporting shortness of breath (she has COPD and has not used her rescue inhaler) and a rapid heart rate.
56 2021-03-25 tingling, slurring About 20 minutes after vaccination when I was released and in my car headed home, my lower lip, left... Read more
About 20 minutes after vaccination when I was released and in my car headed home, my lower lip, left side only, started tingling. My tongue felt fat but didn?t appear fat. However, I slurred about six words. Then one tip of finger started tingling. I had no other symptoms. I immediately took one child Benadryl pill (half an adult dose). I had an epi-pen ready but didn?t need it (I?ve never had anaphylactic reaction before, but my throat has tightened from malic acid before, so I wanted to be prepared). I went home and slept rest of afternoon, probably because of the Benadryl. I had no respiratory issues; no hives; throat did not swell. Just lip tingling, ?fat? feeling tongue, and finger tip tingling.
56 2021-03-26 numbness and pain in extremities, pain in extremity March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the ch... Read more
March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the chest and palpitations. I was given anti-nausea medication. I found the longer that I spoke the tighter and more sore my throat felt. Symptoms of lightheadedness, headaches, brain fog, pain in throat, ear pressure, nausea, diarrhea, body aches and pain, chills, fever of 102 at 6am on March 27th, neuropathy was exacerbated, palpitations and sore left arm. I feel a sharp pain in my right arm, deltoid muscle, when I try to lift it, I can barely move it. It feels as if I had the shot there but I know it was in the left arm for both doses. March 27th all symptoms continue and my temp is fluctuating between 99.5 and 100.5 so far today. March 5th 2021- Dose 1 Within 10 minutes I started to feel the vaccine. I felt a few pangs, brain fog, and exhaustion. The first night I had terrible nightmares. The first three days I experienced dizziness, light headed and off-balance, headaches, brain fog, pain in throat, ear pain, tinnitus and pressure, nausea, diarrhea, body aches and pain, difficulty breathing, chills, fever of 99.5, neuropathy was exacerbated, heart racing and palpitations and sore arm. On the fourth day, I felt normal but was very tired. On the fifth day (March 9th) I again felt exhaustion, brain fog, throat and ear pain, loose stools, body aches and pain, sharp chest pain and neuropathy.
56 2021-03-26 tremor Fever, chills, shaking, body aches, and underarm lymph nodes swelled more
56 2021-03-27 hot flush Fatigue, joint pain, soreness at vaccine site, hot flashes, chills
56 2021-03-27 muscle spasms Pfizer-BioNTech COVID-19 Vaccune EUA Headache, alternating chills/sweating throughout the day, Lowe... Read more
Pfizer-BioNTech COVID-19 Vaccune EUA Headache, alternating chills/sweating throughout the day, Lower intestinal distress including cramps and minor diarrhea, general muscle aches between shoulders. Occurring on Day after injection (3/12/21), 3 days after injection (3/14/21), 5 days after injection (3/16/21), 7 days after injection (3/18/21), and continuing every other day to every 3rd day through today (3/28/21).
56 2021-03-27 pain in extremity, tingling, numbness almost immediate crushing pain in forearm, hand went numb and fingers tingling. sensation of back in... Read more
almost immediate crushing pain in forearm, hand went numb and fingers tingling. sensation of back into neck and head. black out feeling.. headache left temple. flashing orange in eyes. lasted for up to 90 minutes.
56 2021-03-27 pain in extremity Swollen under arm swelling and painful Same arm as the injection site began 24 hours after receiving... Read more
Swollen under arm swelling and painful Same arm as the injection site began 24 hours after receiving vaccination (3/21/21) stopped (3/23/2021)
56 2021-03-27 tremor Lightheaded, chills and shaking, fever, diarrhea
56 2021-03-28 weakness, muscle spasms Back pain, spasms, weakness, tiredness. Treatment: Advil 800 mg
56 2021-03-28 weakness Fever 100.4, severe headache, diarrhea, nausea, lack of appetite...fever lasted 36 hours then droppe... Read more
Fever 100.4, severe headache, diarrhea, nausea, lack of appetite...fever lasted 36 hours then dropped to 97.3...symptoms severe missed 5 days of work...brain felt like it was swollen, also felt dizzy...started feeling like able to do daily routine on Saturday 3/27...but still weak and tire easily. Also, since this..my poop looks yellowish and floats every time. To be honest I am afraid of getting the 2nd vaccine.
56 2021-03-28 numbness Numbness in both hands for about 1 hour
56 2021-03-28 muscle spasms, pain in extremity Extreme tiredness two hours post vaccine. Eleven hours post vaccine, extreme nausea, headache, body ... Read more
Extreme tiredness two hours post vaccine. Eleven hours post vaccine, extreme nausea, headache, body aches, chills, fever, pain at vaccination site. 24 hours post vaccine: Extreme nausea and vomiting, diarrhea, fever, body pain, difficulty remaining awake, extreme aversion to light and sound, headache. Currently 96 hours post second dose of Pfizer vaccine and still have leg aches, cramps, severe tiredness and diarrhea.
56 2021-03-28 pain in extremity 24 hrs after vaccine red hot swollen >5cm area at injection site, severe body aches, head ache, and ... Read more
24 hrs after vaccine red hot swollen >5cm area at injection site, severe body aches, head ache, and chills, 75hrs from vaccine swollen axillary lymph nodes (same arm as vaccine) >10cm in diameter, very painful with pressure on the inside of the left arm extending to the elbow.
56 2021-03-28 tingling 3/26/2021 - Approximately 20 minutes after the injection I started having tingling in my right hand.... Read more
3/26/2021 - Approximately 20 minutes after the injection I started having tingling in my right hand. Same side as injection. I started having tingling and itchy gums itchy throat and itchy ears. My throat swelled up on both sides. All of the above in mild form. I was still sitting in my car in the parking lot & remained there for an additional 30 minutes to make sure it did not get worse. I subsequently ate lunch and continued with my day. Around 9:45pm I went to bed and found that when I would lie down I experienced increased difficulty in swallowing as neck was still swollen both sides under ears and around jaw line. At 10:00pm I took 1 single 25mg Benadryl tablet. Swelling subsided noticeably within 20 minutes. The following day (3/27/2021) much improved with only slight swelling on the left side of my throat under my left ear and along jaw line. Right arm sore from shoulder down to my wrist. By the end of the day my arm was no longer sore. Left side of my throat was still slightly swollen. At bedtime I took 1/2 of a 25 mg Benadryl tablet. Felt fine on Sunday however i still feel as if i have slight swelling
56 2021-03-28 tingling 20 minutes after receiving first covid-19 vaccination , pt started feeling tingling in arm and hand,... Read more
20 minutes after receiving first covid-19 vaccination , pt started feeling tingling in arm and hand, however, proceeded home. Later in the evening pt felt throat start to swallow but didn't notice problem breathing until bed, at which time pt took a Benadryl and went to sleep. Two days later pt stated she was feeling much better but was advised to not take second vaccine without PCP MD's approval.
56 2021-03-28 tremor Immediately after injection (within 5 minutes) I was shaky and short of breath. I recovered within ... Read more
Immediately after injection (within 5 minutes) I was shaky and short of breath. I recovered within few minutes. Minor Anaphylaxis?
56 2021-03-29 bell's palsy Bell's Palsy (Right side of face)
56 2021-03-29 burning sensation, nerve pain, pain in extremity bilateral wrist and hand pain -like nerve pain for about 3 weeks then both ring fingers have had ner... Read more
bilateral wrist and hand pain -like nerve pain for about 3 weeks then both ring fingers have had nerve pain ever since. a few times underside of toes has burned sometimes aches inner ankle bone Today the nerve pain is my right index finger and knuckle. I had NONE of these things until after dose 2 of the pfizer vaccine
56 2021-03-29 feeling hot, tingling The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vac... Read more
The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vaccine and sat down in the chairs to wait the required 15 minutes. Within 2-3 minutes my face got very hot. I could feel the heat under my mask. Another minute or two, just below my knees to my toes started tingling. Another two minutes or so, I felt like my eyes were swelling. I took my glasses off and looked at my husband and asked if my eyes are swelling, he said, they sure are and called over one of the paramedics that were there. They directed me to a more private are and put me on a monitor and monitored my vital signs. My blood pressure which is well controlled on my meds (which I did take that morning) climbed and climbed to 200s/100s. My chest was tight and uncomfortable and getting more difficult to breath. They put and 02 mask on and gave me Benadryl IM. By that time the squad was there and took me to the local hospital ER. In the squad my tongue started to swell. At the hospital they gave me Solumedrol IV which took care of it all. The swelling quickly went away in my tongue and face, the chest pressure went away, and all the other little annoyances like the tingling. The hospital did a chest x-ray and bloodwork. I went home after 3-4 hours with a prescription for Prednisone 50 mg daily for 5 days. No further reactions after that.
56 2021-03-29 numbness, pain in extremity, cold extremities, feeling jittery Immediately could taste the vaccine in the middle of my tongue, started to feel jittery, hands grew ... Read more
Immediately could taste the vaccine in the middle of my tongue, started to feel jittery, hands grew cold after 4 minutes, felt spacey, felt numbness in the tips of middle fingers of right hand, face started to feel slightly numb from right to left, tongue started to swell on the left side, lips felt thick. This was a progression of 15 minutes. Vitals taken by EMT - all in normal range. I could walk cautiously. It was a matter of drinking water, eating oyster crackers without salt, and waiting. Left the facility about 11:30am and went for Benadryl. Benadryl helped some (taken about 11:45am) This also affects my serotonin levels making me sad and edgy. Restless afternoon, initial event subsided. Right arm hurt. Needed more Benadryl (1 tablet again) the next day. Added 2 ibuprofen in evening. Spacey, unsettled, fatigued. No fever. Monday: Brain fog most of day. Tuesday: brain fog lifting, but pain occurring in left hand in knuckles and fingers.
56 2021-03-29 pain in extremity, tenderness A rash developed; Within three hours of receiving the Pfizer vaccine my right thigh became painful; ... Read more
A rash developed; Within three hours of receiving the Pfizer vaccine my right thigh became painful; started itching; area of the rash is tender when pressure is applied; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Left arm on 16Feb2021 16:00 as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. If Other vaccine in four weeks: No. Facility type Vaccine: Doctor's office/urgent care. if Covid prior vaccination: No, if covid tested post vaccination: No. known allergies: n/a. The patient experienced a rash developed (non-serious) on 16Feb2021 18:30, within three hours of receiving the pfizer vaccine my right thigh became painful (non-serious) on 16Feb2021 18:30, started itching (non-serious) on 16Feb2021 18:30, area of the rash is tender when pressure is applied (non-serious) on 16Feb2021 18:30. if treatment AE: No. Within three hours of receiving the Pfizer vaccine my right thigh became painful and started itching. A rash developed, about 5" wide and 6" long. The itching lasted about two to three hours. Twenty-four hours after the vaccine, the rash remains and the area of the rash is tender when pressure is applied. For event rash developed, area of the rash is tender when pressure is applied, outcome was not recovered and for started itching, outcome was recovered on unspecified date in 2021, for other remaining, outcome was recovering.
56 2021-03-29 pain in extremity Felt sick went to bed when I got home from work, some tummy upset, stomach upset on Saturday, Arm wa... Read more
Felt sick went to bed when I got home from work, some tummy upset, stomach upset on Saturday, Arm was sore for about 48 hours, felt a little tired, some bathroom issues
56 2021-03-29 tingling, numbness and pain in extremities tingling in face and fingertips; heightened neuropathy in feet; Headache; fatigue; This is a spontan... Read more
tingling in face and fingertips; heightened neuropathy in feet; Headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6703) via an unspecified route of administration, administered into the left arm on 09Mar2021 17:00 as a single dose for COVID-19 immunisation. Medical history included guillain-barre syndrome survivor and breast cancer survivor. Patient was not pregnant. Concomitant medications included levothyroxine sodium (LEVOXYL), hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN+HCTZ/MYLAN) and letrozole (LETROZOLE). On 09Mar2021, patient experienced headache and fatigue. On 10Mar2021, she had heightened neuropathy in feet. On 12Mar2021, she experienced tingling in face and fingertips. The patient did not receive treatment for the events reported. Outcome of events was not recovered.
56 2021-03-30 weakness Shortly after vaccine administration, the pt honked her car horn for help and was noted to be minim... Read more
Shortly after vaccine administration, the pt honked her car horn for help and was noted to be minimally responsive. Initial BP was noted to be 60/palp. She was promptly given a dose of epi (epipen) at appx. 0830. She did not improve immediately and required a second dose of epi. Prior to transport by EMS, she improved slightly and denied any respiratory symptoms or skin involvement. She complained of feeling weak and tired only. SP02 was 89% and HR was in the 70s and regular. 02 was administered by EMS and she was given a dose of Benadryl, 25mg as well. While EMS was still on scene with the pt, BP improved to 130 systolic and she was noted to be significantly improved. She had a significant period of hypotension for appx. 20 minutes however (prior to improvement). Unclear if she had a prolonged vasovagal response or possibly anaphylaxis. She did not have clear mucosal, respiratory or GI involvement to suggest a definite diagnosis of anaphylaxis. She was transported to local ER by EMS in improved condition.
56 2021-03-30 weakness Severe headache, low fever diarrhea, severe muscle and joint pain and weakness, chills, first insomn... Read more
Severe headache, low fever diarrhea, severe muscle and joint pain and weakness, chills, first insomnia,, then extreme fatigue. Symptoms persisted until Tues. 3/30/21.
56 2021-03-30 pain in extremity Fatigue, muscle aches, dizziness, headache, chills for a day after. 2nd days just fatigue and left a... Read more
Fatigue, muscle aches, dizziness, headache, chills for a day after. 2nd days just fatigue and left arm is sore. Only arm was sore after first shot.
56 2021-03-30 pain in extremity Evening of injection. Serve pain in whole arm and arm pit into part of right chest first night. Swel... Read more
Evening of injection. Serve pain in whole arm and arm pit into part of right chest first night. Swelling of right arm to hand, fluid in and around arm pit. Next day, fever 102.7 headache, joint pain, muscle pain, and arm still affected. Day 2, still fluid in arm pit area and headache. Evening of day 2 ran fever of 102.6 with pain on right side of ne k and headache. Day 3 headache and fluid in and around arm pit has subsided a bit.
56 2021-03-30 tremor, migraine Violent shaking, vomiting, fever of approx 99-100 varying, extreme nausea , dizziness, feeling was... Read more
Violent shaking, vomiting, fever of approx 99-100 varying, extreme nausea , dizziness, feeling was about to pass out, body aches like hit by a freight train, woke up in the middle of the night Thursday approx 3AM and was blindsided. Could not move from bed for the next 24 hours. The vomiting stopped and second 24 hours into Friday extreme nausea and migraine headache began. Headache and nausea continues to today 3/31/2021.
56 2021-03-30 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
56 2021-03-31 burning sensation immediately: nausea, burning (heat) 5 minutes after: throat swelling, burning and itching under skin... Read more
immediately: nausea, burning (heat) 5 minutes after: throat swelling, burning and itching under skin (but no hives) 24 hours after: redness and then swelling (2.5 inches) at injection site; currently bruising and spreading of bruising (red to brown, with darker spot where injection occurred and outside it), soreness in injection spot expected: fever, chills, headache, dizziness, arm soreness See Item 20: continuing: bruising of arm (bruise is spreading) and arm is still sore Treatment: iced arm immediately, Aleve for pain, rest
56 2021-03-31 cold sweat From Midnight on 3/28 - Low grade fever (up to 103.1), chills, extreme headache, nausea, aches, cold... Read more
From Midnight on 3/28 - Low grade fever (up to 103.1), chills, extreme headache, nausea, aches, cold sweats, dizziness, extreme fatigue through Sunday, 3/29 mid-morning. Sunday, 3/28-headache, nausea, dizziness, extreme fatigue and cold sweats Monday, 3/29-nausea, dizziness, extreme fatigue and cold sweats Tuesday, 3/30-dizziness, extreme fatigue, loss of appetite Wednesday, 3/31-fatigue, loss of appetite Thursday, 4/1-loss of appetite
56 2021-03-31 numbness Tingling, numbness starting in right upper lip, spreading up to orbital area/temple - stroke-like sy... Read more
Tingling, numbness starting in right upper lip, spreading up to orbital area/temple - stroke-like symptoms
56 2021-03-31 migraine Migraine with pain level of 9; nausea, joint aches to where moving is difficult and extremely painfu... Read more
Migraine with pain level of 9; nausea, joint aches to where moving is difficult and extremely painful. hand swelling; chills and low grade fever.
56 2021-04-01 weakness Severe muscle pain, weakness and stiffness. Lasted 6 days Treated with antihistamines
56 2021-04-01 burning sensation I got all over on me an allergic skin reaction redness burning, very itchy and painful sensation
56 2021-04-01 pain in extremity Nausea Headache Sore arm Tired
56 2021-04-01 pain in extremity Patient complained of mid sternium chest pain after vaccination. Pain radiated down arm. Onsite EMS ... Read more
Patient complained of mid sternium chest pain after vaccination. Pain radiated down arm. Onsite EMS called HR 77 BP 130/79, patient stated at 4:17 pm pain was resolved and went home.
56 2021-04-02 weakness Started with cold chills around 11:00 pm April 1st with aches and pain all over the body. Headache.... Read more
Started with cold chills around 11:00 pm April 1st with aches and pain all over the body. Headache. Low grade fever of 99.9F. No energy. These symptoms lasted till April 3rd 8:00 am. No aches or pains but energy level still low. Tylenol every 4 hours. Vicks rubbed on chest. Rest
56 2021-04-02 feeling hot Headache, Tiredness, bodyaches, very warm feeling inside body day of shot. Today is day two symptom... Read more
Headache, Tiredness, bodyaches, very warm feeling inside body day of shot. Today is day two symptoms seem worse and develop the 100.9 fever till next morning. Entire body of bones and skin is aching. Breathing is shallow and my ribs are hurting, when I move I get sharp pains as well in the rib area or what organs are under the ribs. I could hold my bladder when I got out of bed. I didnt know I was urinating myself until I felt it going down legs.
56 2021-04-02 feeling hot felt hot probably had a fever but our thermometer didn't work. chills, aches, felt like the flu. la... Read more
felt hot probably had a fever but our thermometer didn't work. chills, aches, felt like the flu. lasted about 24 hours
56 2021-04-02 pain in extremity Chest cavity very sore, coughing, sore throat, throat congested, nose congested, fatigue, back pain ... Read more
Chest cavity very sore, coughing, sore throat, throat congested, nose congested, fatigue, back pain and leg pain?
56 2021-04-02 pain in extremity Very sore arm, muscle heaviness
56 2021-04-02 pain in extremity Severe arm pain that prevented sleeping on both left or right side, difficulty getting dressed and u... Read more
Severe arm pain that prevented sleeping on both left or right side, difficulty getting dressed and undressed the next day. Arm pain resolved after 40 hrs. Extreme fatigue beginning hours after injection and continuing through present. Routine long walks now result in need to rest for the remainder of the day. Fatigue examples: too tired to walk the dog, too tired to do daily chores, too tired to cook.
56 2021-04-03 feeling hot within a few minutes I started getting very hot and then I got very sweaty. I removed my coat and pu... Read more
within a few minutes I started getting very hot and then I got very sweaty. I removed my coat and put on the air conditioner. Next I started seeing blue colors before my eyes and at that time honked my horn for help. My blood pressure tanked, my heart rate increased. I was given 2 does of EpiPen, and Benadryl. I then was brought to the hospital and was given oxygen en route. At the hospital, I was monitored and given 10mg of Decadron
56 2021-04-03 mild one side paralysis Within about 10 minutes of receiving the vaccine, I had increased heart rate (lasting less than 5 mi... Read more
Within about 10 minutes of receiving the vaccine, I had increased heart rate (lasting less than 5 minutes) and a feeling of weakness on all of the left side of my body. This weakness lasted about 2 days. I also felt an internal itching in various parts of my body. It has been almost three weeks and I still feel itching throughout my body. There was never a rash anywhere, just this internal itching.
56 2021-04-03 numbness, tingling Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Addit... Read more
Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: She felt her whole left side of her face and arm was causing a tingling and numbing sensation. Patient felt better, thinks it may have been a panic attack. left store without incident.
56 2021-04-03 migraine Fever Migraine headache Vomiting Diaerea Horrible body aches Neck especially can?t move injection a... Read more
Fever Migraine headache Vomiting Diaerea Horrible body aches Neck especially can?t move injection arm Red cheeks as res as Santa Claus suit. Felt great yesterday up to 15 hours after no horrible
56 2021-04-03 pain in extremity, speech disorder Very sore arm for several days after shot. On day 9 I started to get a low grade fever, body aches,... Read more
Very sore arm for several days after shot. On day 9 I started to get a low grade fever, body aches, headache, upset stomach and extreme fatigue. Day 10 I was having severe memory issues. I struggled with putting words together and forgetting things like passwords and even how to turn off my computer. My husband was very alarmed and thought I was having a stroke. He took me to the ER.
56 2021-04-03 pain in extremity SEVERE pain in right leg, to the point that it's difficult to stand/walk.
56 2021-04-03 pain in extremity Pain on the arm; This is a spontaneous report from a contactable consumer (patient) via Medical Info... Read more
Pain on the arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. This consumer reported similar events for two patients (herself and her husband). This is the first of two reports. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 22Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain on the arm in Mar2021. The patient was referred to a healthcare professional for treatment. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021324105 same reporter/drug, different patient/events
56 2021-04-03 pain in extremity Day1- fingers hurt Day 2- dizziness, fatigue, not thinking clearly Day 3- arm burning hot and swoll... Read more
Day1- fingers hurt Day 2- dizziness, fatigue, not thinking clearly Day 3- arm burning hot and swollen at injection site. Worsening Fatigue, headache. Day 4- fatigue, headache, depression, arm still burning hot
56 2021-04-03 pain in extremity Within a couple of hours of receiving the vaccine shot 1 of 2 I became very nauseous and I vomited a... Read more
Within a couple of hours of receiving the vaccine shot 1 of 2 I became very nauseous and I vomited about 4-5 times. I also felt tired and generally under the weather. Later in the evening I felt better after several hours. The next morning I felt much improved. Arm pain followed.
56 2021-04-04 weakness everything hurts, no energy, arm swelled and turned red. headache.
56 2021-04-04 feeling cold swollen left hand, chills, headache, body aches, swollen lymph nodes in left armpit, fatigue, post m... Read more
swollen left hand, chills, headache, body aches, swollen lymph nodes in left armpit, fatigue, post menopausal bleeding/spotting/cramping, increased pain in healing right torn rotator cuff
56 2021-04-04 flushing, numbness, tingling Pt @1055 reported tingling and numbness, then flushed through all body and felt palpitations for a m... Read more
Pt @1055 reported tingling and numbness, then flushed through all body and felt palpitations for a minute. @ 1125 pt verbalizes that she "feels fine" and denies any new or continuing symptoms. States that her throat is dry but declines to drink water stating she has water in her car and will just get that. @1204 attempted to contact pt on mobile phone for FU but no answered. LVM
56 2021-04-04 numbness, muscle spasms, burning sensation Leg cramps started about 1 hour after the vaccine was administered. About 6 hours after vaccine, deb... Read more
Leg cramps started about 1 hour after the vaccine was administered. About 6 hours after vaccine, debilitating headache. Numbing of hands and feet along with headache. On the next day: diharrea, joint pain, burning sensation in hands and feet, nausea, mild rash on both arms, increased heart rate, eye twitching
56 2021-04-04 muscle spasms 3 weeks past 2nd covid shot, patient developed nausea, diarrhea, malaise and significant muscle cram... Read more
3 weeks past 2nd covid shot, patient developed nausea, diarrhea, malaise and significant muscle cramping that seems to rotate through different muscle groups. Also experiencing cramping that feels like cramps from menstruations but patient is post menopausal. She wakes from headaches every morning now. Most severe symptoms were from 3/31-4/3/21. Diarrhea and nausea have resolved, but headaches and muscle cramping still continue.
56 2021-04-04 tingling tingling on left side of face, headache
56 2021-04-05 weakness, numbness, tingling, feeling hot After about 15 min I started to get numbness, tingling , and swelling on my entire left side. It inc... Read more
After about 15 min I started to get numbness, tingling , and swelling on my entire left side. It included difficulties seeing and lack of hearing on the left side. I could feel the "blood flow" in my head, which was super uncomfortable, because I was afraid of getting a stroke. I went to report to the Medical Doctor on side at the Convention Centre. They kept monitoring blood pressure and my responses. Nothing really was done. Symptoms stayed for about 1.5 hours the same. After that they decreased but my side was still numb and swollen (not back to normal). However, I left to go home. After about 24 hours those symptoms were gone and only headache, fatigue remained. I received my second vaccination on 04/04/2021 at about 1:15P: Pfizer, Lot#ER8733 There, I used my right arm. Same thing, after about 15 min, I started to get tingling, numbness, difficulties hearing and seeing. Headache was worse than the first time. Again I remained under observation for about 1h. No results. Symptoms lessened. I went home. At night I developed nausea, severe kidney pain, had to vomit several times, and had a weird hot feeling inside my body=could feel my blood flow. It felt as if it was really hot. it was extremely scary, as I again was afraid of developing a stroke. Now, 2 days later, I still am feeling extremely weak, nauseous, headaches, some numbness.
56 2021-04-05 burning sensation small red hives around left wrist, then continued to spread in small hives and red dots on the back ... Read more
small red hives around left wrist, then continued to spread in small hives and red dots on the back of both of my hand down into my fingers. with some small red dots on both forearms. hand are red and burn slightly. i've noticed that above my ankles on both legs (posterior) their is a dark marking, not a bruise, however could possibly pass as one. i have not noticed rashes or hives anywhere else.
56 2021-04-05 feeling jittery Pt reported feeling "jittery" while waiting in waiting lot after receiving vaccine dose. BP 138/90 ... Read more
Pt reported feeling "jittery" while waiting in waiting lot after receiving vaccine dose. BP 138/90 @ 0915 AND 126/82 @ 0923, hr 80, r 14 On BP meds for HTN did take meds this AM Symptoms resolved after 15 minute was allowed to leave lot, RN spoke after pt by phone at 1700 was home and fine
56 2021-04-05 numbness, tingling, pain in extremity Day 1: injection was in right arm immediate strong taste of metal in mouth after injection right sid... Read more
Day 1: injection was in right arm immediate strong taste of metal in mouth after injection right side of face had tingling all symptoms were greatly lessoned by the end of the 20 minute wait Day 2: major injection site soreness/no other symptoms Day 9: right side of face severely numb middle tip of eyelid had constant twitch tightness in right check and side of face, up into the eye socket severe tingling, like after a dental appt with too much Novocain slight metal taste no drooping/drooling/sagging of face vision seemed fine/motor skills fine Day 10: same symptoms as day 9 with added right arm pain bicep in right arm, wrist and fingers numb Day 11: Drs appt 9:20am same numb/Novocain feeling in face more heav
56 2021-04-05 pain in extremity Had mild reaction-sore arm & fatigue-after first dose of Pfizer on 03/09/2021 (EN6208), and reaction... Read more
Had mild reaction-sore arm & fatigue-after first dose of Pfizer on 03/09/2021 (EN6208), and reaction went away after a day. But had an adverse reaction to the second dose of Pfizer as reported here on 03/30/2021 (ER8733). Received shot in the morning & had sore arm & fatigue in evening. But 48 hrs later, I broke out in hives all over my body. Took Benadryl & used over the counter hydrocortisone cream. Hives finally went away 04/05/2021. I think, but not 100 percent sure, that the second dose of the vaccine was the cause of my hives.
56 2021-04-05 tingling, feeling hot Face turned hot and red about 30 minutes after the vaccination. A few minutes later, a tingling sens... Read more
Face turned hot and red about 30 minutes after the vaccination. A few minutes later, a tingling sensation began, followed by a general feeling of fullness throughout my face, as if my face was swelling. This was very concerning, and I began checking in the mirror for physical swelling in my face. The sensations of tingling and fullness continued for 30-45 minutes. My face was still red and hot for 6 hours after the vaccination.
56 2021-04-05 tingling Swollen lips and face/ tingling Difficulty swalling Difficulty breathing VERY thursty Very soar thro... Read more
Swollen lips and face/ tingling Difficulty swalling Difficulty breathing VERY thursty Very soar throat Racing heart rate High blood pressure Went to the ER. They were able to lower my racing heart with a beta block. Still suffering elevated heart rate and high blood pressure. No prior history of heart problem or high blood pressure.
56 2021-04-05 restless legs syndrome Received vaccine at 3:25. At midnight I began have restless legs, pain in joints and muscles. Headac... Read more
Received vaccine at 3:25. At midnight I began have restless legs, pain in joints and muscles. Headache, diarrhea, chills and fever.
56 2021-04-06 weakness, feeling hot Received the vaccine April 5th 2:00pm, April 6th around 9:00am I started feeling hot, slight fever a... Read more
Received the vaccine April 5th 2:00pm, April 6th around 9:00am I started feeling hot, slight fever and slight chills throughout the morning. Around 1:00pm it became worse. Around 3:30 I had full fever of at least 101.5 with constant chills, felt very week with a headache and feeling like a sinus infection all lasting thru the evening. My Wednesday morning April 7th temp was down to 101.1, still felt week, headache and some sinus drainage . I took Advil and Tylenol during this. Didn?t felt the need to see a doctor.
56 2021-04-06 weakness, pain in extremity, tension headache Received first dose Pfizer (LOT# EW0150) on 4/02/21. Pt raised hand and stated to EMT that she had p... Read more
Received first dose Pfizer (LOT# EW0150) on 4/02/21. Pt raised hand and stated to EMT that she had pain in her chest, shoulders, back/neck and down both of her arms 4-5/10 on pain scale. Pt stated that she started feeling dizzy with blurry vision and a tight feeling in her head. EMT moved pt to gravity chair. Pt progressively got weaker and more drowsy. PHN offered pt EMS. Pt declined EMS. PHN recommended EMS to be called. Pt agreed for EMS to be called. EMT took pt vital signs at 1317. BP: 124/76, HR: 78. EMS arrived on scene at 1325 and took over. Pt left vaccination site via gurney with paramedic. Pt was transported and left in ambulance at 1335.
56 2021-04-06 weakness, tremor On Saturday 4/3, about 6 hours after shot, I began to have cold chills. Within 2 hours later I was ... Read more
On Saturday 4/3, about 6 hours after shot, I began to have cold chills. Within 2 hours later I was so tired that I went to bed. I have never shook so much from cold chills. Fever reached 103.8 during the night. I did feel nauseous a couple of times, but no vomiting. Drank lots of water but no appetite. On Sunday 4/4, stayed in bed and slept - waking every 2-3 hours. On Monday 4/5, feel better - just really tired. Still unable to sleep more than 2-3 hours at a time. Still no appetite but forced myself to eat a little. On Tuesday 4/6, feel better than day before. Still really tired. No energy. Still sleeping 2-3 hours at a time. Appetite coming back slowly.
56 2021-04-06 weakness pt said she could feel the medicine running through her body after getting the injection. Pt state... Read more
pt said she could feel the medicine running through her body after getting the injection. Pt states a few days after taking the vax she woke up with her right arm hurting. This pain lasted for about a week. The pain went away from the right arm and moved to the left arm. She has pain all over, in her legs, knees, and her feet. She became very weak. She has not been able to eat because her taste buds have not been the same. She has to make herself eat to be able to take her medicines. She has developed a cough and is SOB. Pt sent her PCP a message in my chart to let her know about her symptoms and to cancel the second vax dose. She says she if very scared and worried she will not return to back to feeling normal.
56 2021-04-06 cold sweat, tingling Patient had a syncope episode, felt tingly, dizzy, and clammy to the touch. Patient's blood pressure... Read more
Patient had a syncope episode, felt tingly, dizzy, and clammy to the touch. Patient's blood pressure dropped to 98/62. Patient legs were elevated and a cold compress was used
56 2021-04-06 severe one side paralysis, muscle twitching I have had Bell?s palsy twice in the past. About ten days after I got the vaccine I started with sor... Read more
I have had Bell?s palsy twice in the past. About ten days after I got the vaccine I started with sores and similar symptoms to Bell?s palsy including twitching and paralysis on my right side. I had some valtrex on hand and started taking them.
56 2021-04-06 nerve pain, tenderness Beginning 5 days after injection on March 16, I started experiencing back pain. The next day, the 17... Read more
Beginning 5 days after injection on March 16, I started experiencing back pain. The next day, the 17th, a small red rash started near my navel with itching and started with headache and malaise. Later that same day I looked on my abdomen and right torso and notice an additional red rash on my right torso, under my arm, leading from my navel. Itching became intense and the pain started. Vesicles stared on the 18th and I was unable to get an appointment until the 19 the where the MD confirmed Shingles. I was started on Valtrex (generic) 1 tab bid for 7 days. The pain was so intense, I was unable to have any clothing, bedding touch the area. I had a fever, chills, intense pain, with inability to raise right arm due to pain. There was also a lymph node that was tender and swollen under my right arm. Treatments included Calamine lotion and OTC Lidocaine applied topically and the fever and headache were managed with Tylenol 500 mg every 3-4 hours until it became unbearable and I requested additional pain meds. The MD gave me Oxycodone which helped some. The lymph node were no longer tender and sore by day the 28th or so. The lesions/vesicles started to dry up by 04/02/21 but the itching persisted and remained very painful. The back pain persisted throughout with difficulty sleeping due to the pain. By the 4th of April, the lesions had dried completly and all the scabs had fallen off. Some of the nerve pain persisted but clothing was more bearable by this time. As of today, there is some itching that remains and some back pain with some tenderness on my right torso.
56 2021-04-06 tremor, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Shakiness-Medium
56 2021-04-07 discomfort 4/7/21 at 7pm Felt faint a little breathing off. Sore throat 8pm and started to feel uncomfortable a... Read more
4/7/21 at 7pm Felt faint a little breathing off. Sore throat 8pm and started to feel uncomfortable and trouble swallowing a little bit.. 10pm felt like lump in throat. 11pm more trouble swallowing and tongue swollen and throat felt swollen. 6am under chin tongue still felt swollen. 2:45pm 4/8 trouble swallowing and felt odd in mouth/throat. Soft palate and uvula swollen and throat felt swollen. 7pm felt faint and breathing off a little. 9:45pm Mouth still swollen. All of this with Benadryl and Motrin in me.
56 2021-04-07 numbness, tingling, pain in extremity, breast pain Left cheek, eye socket and nose felt numbness and tingling and slight swelling of left side of face.... Read more
Left cheek, eye socket and nose felt numbness and tingling and slight swelling of left side of face. It started around 10:30 am and most of the numbness and tingling eased up by 3:30 pm, except for numbness in eye socket and tingling in nose. Pain in left arm and woozy feeling most of the day, pain in left collar bone and down left shoulder blade and left breast. The pain has been consistent but not extreme. I have used Tylenol so the pain is bearable.
56 2021-04-07 muscle spasms I woke up in the middle of the night following the shot with leg cramps, body aches, headache and fa... Read more
I woke up in the middle of the night following the shot with leg cramps, body aches, headache and fatigue. I contracted Covid back in January and I felt just like I did while infected, except for the chest heaviness. This lasted about 36 hours and completely went away.
56 2021-04-07 numbness and pain in extremities I have reported this event previously. I want to report this event because I am continuing to be sym... Read more
I have reported this event previously. I want to report this event because I am continuing to be symptomatic. After my first covid vaccine on March 5th 2021, I was sick for 4 days, then the following day I was ok, and then the next day I was sick for the day. The second covid vaccine, March 26th 2021, I was sick for six days then I felt ok for three days, and on April 5th I became symptomatic again and it has continued through today April 8th. Tired/exhausted dizziness headaches brain fog nausea body aches and pain fever 99-102 neuropathy difficulty breathing palpitations
56 2021-04-08 numbness, pain in extremity Pt c/o of L arm pain and numbness that started a few minutes after vaccine was administered. Vitals ... Read more
Pt c/o of L arm pain and numbness that started a few minutes after vaccine was administered. Vitals signs stable; 114/70, pulse 66, RR 16, O2 sat 98% RA. Pt transferred to Adult family medicine.
56 2021-04-08 pain in extremity I have continued stiffness and pain in my left arm. I have limited range of motion. I can't lift m... Read more
I have continued stiffness and pain in my left arm. I have limited range of motion. I can't lift my arm or put it behind my back without considerable pain.
56 2021-04-08 pain in extremity Side effects began about 14 hours after 2nd dose. Fever, extreme pain in back, legs, head and arm pi... Read more
Side effects began about 14 hours after 2nd dose. Fever, extreme pain in back, legs, head and arm pits. Dizziness. Still experiencing side affects 30 hours later.
56 2021-04-08 pain in extremity Upper left arm pain, temperature spike to almost 102 F, Dizziness, Body aches, upper leg pain. Taki... Read more
Upper left arm pain, temperature spike to almost 102 F, Dizziness, Body aches, upper leg pain. Taking OTC med for fever reducer and mild pain reliever
56 2021-04-08 tingling Tingling in toes across both feet 2 days after the vaccine.
56 2021-04-09 feeling hot At 2 a.m., Patient began getting very sick. She has a fever. She reports her whole body feels it is ... Read more
At 2 a.m., Patient began getting very sick. She has a fever. She reports her whole body feels it is on fire. She can not sleep.
56 2021-04-09 feeling hot dizziness; hot; This is a spontaneous report received from a non-contactable other healthcare profes... Read more
dizziness; hot; This is a spontaneous report received from a non-contactable other healthcare professional. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205) via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunisation. Medical history included multiple sclerosis and complained of a weakness in her legs that she experiences during her flares. She does mention having to be on 2L oxygen at times when she has a flare. The patient's concomitant medications were not reported. On 24Mar2021, patient began to experience dizziness and hot. She was treated with water and lying in trendelenburg position. Outcome of events was unknown. No follow up attempts are possible. No further information is expected.
56 2021-04-09 hot flush Started having hot flashes after not having them for over 3 years
56 2021-04-09 migraine Soreness from injection left arm subsided after a day Bad Migraine next day - Migraines / headaches ... Read more
Soreness from injection left arm subsided after a day Bad Migraine next day - Migraines / headaches are chronic condition already prescribed meds helped Mouth sores - still experiencing Mild sore throat - still experiencing
56 2021-04-10 weakness High Fever 104-105; Vomiting; Aches; Weakness; Lightheaded; Nausea; Fatigue; Injection site extremel... Read more
High Fever 104-105; Vomiting; Aches; Weakness; Lightheaded; Nausea; Fatigue; Injection site extremely sore.
56 2021-04-10 breast pain Headache, fever, chills, neck pain, body and joint aches, left breast pain and fever, injection site... Read more
Headache, fever, chills, neck pain, body and joint aches, left breast pain and fever, injection site pain and fever. All side effects lasted three days.
56 2021-04-10 feeling cold Freezing, could not get warm.
56 2021-04-10 feeling hot Chills, burning up , legs weak , barely able to walk , slept for 18 hours straight
56 2021-04-10 feeling of body temperature change I awoke to pain all over my body, and was either too hot or too cold, and could not sleep because of... Read more
I awoke to pain all over my body, and was either too hot or too cold, and could not sleep because of the discomfort. At 2p on 04/10/2021, the pain and chills stopped. I slept from then until 7a today (04/11/2021). Today I feel good, but feel like I had a really hard workout yesterday.
56 2021-04-10 flushing Tingly tongue shortly after the injection that is still there the day after. I think it's going dow... Read more
Tingly tongue shortly after the injection that is still there the day after. I think it's going down. Also, a little metallic taste in the mouth right after getting the shot too. Feeling flush in the face and sweating a lot about 2 hours after but that went away about an hour or two later. Soreness in left arm where the injection was given.
56 2021-04-10 pain in extremity A few hours after injection, I noticed pain in my right arm at injection site with redness. Also a b... Read more
A few hours after injection, I noticed pain in my right arm at injection site with redness. Also a bit of nausea, and chills. I also experienced headache and congestion. The following day I had a very strong headache and very strong pain at injection site as well as swollen lymph nodes. On the third day I still have headache and pain in my arms as well as a swollen lymph nodes
56 2021-04-10 pain in extremity 102.5 fever, chills, severe headache, body aches, nausea, vomiting, arm pain and swelling
56 2021-04-10 pain in extremity Vaccine was given at 4:10pm on Wednesday, March 31. My side effects didn't begin until 46 hours afte... Read more
Vaccine was given at 4:10pm on Wednesday, March 31. My side effects didn't begin until 46 hours after receiving vaccine. Fever of 101 began at 2pm on Friday, April 2 and lasted about 12 hours. The following day no fever but my arm was suddenly sore and achy (it had not been achy at all before), I had a headache and felt wiped out. These symptoms lasted untill about 6pm on Saturday, April 3. Completely recovered by the evening.
56 2021-04-10 pain in extremity I had a sore arm, headache and chills on April 9 and 10. On April 11, I woke up about midnight with... Read more
I had a sore arm, headache and chills on April 9 and 10. On April 11, I woke up about midnight with chills, headache, sore lymph node in left arm and nausea. I had vomiting and diarrhea with severe dizziness and felt like I was going to pass out.
56 2021-04-10 pain in extremity sinking sense of doom-death; high heart rate; BP is spiking to 165/100; mile fever; sore arm; Severe... Read more
sinking sense of doom-death; high heart rate; BP is spiking to 165/100; mile fever; sore arm; Severe headache; blood sugar spikes of 200 fasting; Increased tahcycardiaI suffer from that) but it was more frequent and severe; chest pains; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 56-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM6199) via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 12:00 at a single dose for covid-19 immunisation. Medical history included had covid from 30Jun2020. Concomitant medication patient received within 2 weeks of vaccination included Metoprolol ER 25 mg cyclic, Armour Thyroid 30 mg cyclic. The patient previously took fluoroquinolones and experienced known allergies. The patient reported that on 13Mar2021 on Day 3 of vaccine BP starts to go up. My average is 100/50. By day 4 BP is spiking to 165/100 with a mile fever and sore arm, and a sinking sense of doom-death). Severe headache and continued blood pressure spikes throughout week along with blood sugar spikes of 200 fasting. I'm not diabetic. Increased tahcycardiaI suffer from that) but it was more frequent and severe. Blood pressure spiked to 187/167, I took extra BP meds (which was low dose more for my tachycardia)to help with insane BP. Went to hospital and stayed for 2 days. No heart attack, Just insane BP with chest pains and high heart rate. Day 18 after shot and BP is going down and so is blood sugar. Every once in a while, it will spike to 160/100--last for about 1 hour and then drop to my normal BP before the shot. The events were considered serious with seriousness criteria hospitalization and medically significant. The patient was hospitalized for 2 days. Adverse events resulted in Emergency room/department or urgent care, Hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Nasal Swab: negative on 23Mar2021. The patient was recovering from all the events. Follow up needed, further information has been requested.
56 2021-04-11 weakness Vomiting, weakness, low temperatures, multiple incidents of vasovagal syncope, 1 resulting in a fall
56 2021-04-11 weakness Pain at injection site right away. Nausea, head ache and some dizziness started on the drive home (... Read more
Pain at injection site right away. Nausea, head ache and some dizziness started on the drive home (within an hour). Within 10 hours I was experiencing severe chills, muscle pain and body aches. Pain and chills were unrelenting and unbearable at 24 hours and I contacted my PCP who advised taking Tylenol 500mg every 6 hours. That lessened my symptoms to moderate headache, chills and body aches for the next 24-hours. Day 3 Nausea, muscle pain lessened but I had extreme fatigue set in and hardly left the chair. Evening of day 3 I began perspiring heavily, felt like a fever breaking.
56 2021-04-11 difficulty speaking Patient reported side effects - Onset: 45 minutes after getting vaccine; Severity: moderate; Symp... Read more
Patient reported side effects - Onset: 45 minutes after getting vaccine; Severity: moderate; Symptoms: Dizziness for 2 hours, can't think clearly. Second Pfizer vaccine -- Got shot at 8:20 AM and started to feel warm at 9 AM, and got dizzy with vertigo. Feels foggy, needs to hold onto furniture to walk. No fever. (With 2nd shingles shot -- next morning achy, exhausted, low grade fever. Only time has ever reacted before). Other symptoms = Ringing ears, fogginess in thought. HISTORY OF PRESENT ILLNESS A 56 y.o. female who presents regarding a potential concern for an adverse reaction to the COVID-19 vaccine. Second Dose in Series: Vaccine was obtained from the following clinic/location: on the date of: 4/9 and approximate time of 8:15 AM Vaccine was administered to patient's: Left Deltoid Vaccine manufacture was: Pfizer Past Reaction to other immunizations- yes: symptoms: second dose of shingles causing flu like symptoms Known COVID Exposure since receiving vaccination?: No Patient notes the following symptoms: disiens, tight throat, scratchy voice, ringing ears. Modifying Factors or additional details: by the time got home after vaccine today - dizzy, ears ringing and symptoms haven't improved. Denies lightheadedness or feeling like she is going to pass out. Voice sounds scratchy, feeling unbalanced. Denies history of vertigo. Throat feels tighter but denies difficulty breathing. Denies tongue or lip swelling. Did take atarax one hour after without relief. Dramamine as needed -Benadryl at night - may make you sleepy -Daily antihistamine (e.g Claritin) -Increase rest and fluids Signs and symptoms that require an Emergency Room Evaluation-rapid breathing, using accessory muscles to breathe, difficulty breathing, severe wheezing, tongue/lip/airway swelling, altered mental status, weakness, visual changes, lightheadedness, not eating or drinking, severe headache, chest pain, neck pain or stiffness, the development of high fevers/chills/overall feeling unwell despite medications, or any new concerning symptom. -Follow up with PCP if no improvement over the next three days
56 2021-04-11 flushing Situation: The patient is in the covid vacciantion clinic today for her second Pfizer vaccination. B... Read more
Situation: The patient is in the covid vacciantion clinic today for her second Pfizer vaccination. Background: Hx of allergies to Shellfish. Assessment: Patient states during observation post injection she feels a little itchy and has some redness on both posterior arms, and on the jaw line present. Face looks flushed. She is in no acute distress. Patient transferred with gurney in supine position, head 70% elevated to private observation/assessment room. Dr. informed. Dr. in the room to examine patient. Order from Dr. for Benadryl 25 mg po given at 1207 pm. Vital signs at 1210: 123/72, Hr 76, O2 Sat 98% on RA. Patient states she is feeling better, itching is improving. Patient is resting in the exam, treatment area. At 1220 the patient states the itching is worsening. Per Dr. Benadryl 25 mg po given. Vital signs at 1225: 117/71, HR 66, O2 Sat 97%. Patient states she is feeling better and the itching is lessening. Vital signs at 1235: 121/69, HR 73, 98% on RA. The patient states the itching in her arms has subsided. No redness noted. The patient states she still has a little itchiness in her jaw line. The patient tolerated the Benadryl well. Informed Dr Recommendation: 1240, the patient was discharged into her husband's care, per Dr.
56 2021-04-11 pain in extremity, numbness My cheeks went numb instantly. My arm hurt right away, but that is normal for me. Then I got extr... Read more
My cheeks went numb instantly. My arm hurt right away, but that is normal for me. Then I got extremely fatigued. I waited the 30 minutes and went home. Within two hours I had chills, low fever, shortness of breath, muscle and body aches, sore throat, congestion. By the morning I still had all of the other symptoms but worse and I had no taste or smell. I had nausea and diarrhea along with all of the other symptoms. I felt terrible for four days. I remained very fatigued and my chest still feels heavy.
56 2021-04-11 pain in extremity sore left arm at night after several hours from time of shot. Pain increased the next day. Felt ve... Read more
sore left arm at night after several hours from time of shot. Pain increased the next day. Felt very tired on the second and tiredness and sore on left arm increased on the third day after the shot. Took excedrin twice a day for 4 days after the shot.
56 2021-04-11 pain in extremity Sore arm, slight headache and some fatigue. All were mild
56 2021-04-11 tremor, feeling hot Red hot arm. Sore. Redness getting bigger. Very lethargic. Headache. Feeling of nausea. Shaking. Diz... Read more
Red hot arm. Sore. Redness getting bigger. Very lethargic. Headache. Feeling of nausea. Shaking. Dizziness.
56 2021-04-12 bell's palsy, face paralysis, numbness weakness numbness on right side of face, numbness in tongue, gums, cheek, and eye, mild dropping wat... Read more
weakness numbness on right side of face, numbness in tongue, gums, cheek, and eye, mild dropping watering of eye. 2 days after vaccine, increasing over following days. Diagnosis-bell's palsey treatment prednisone
56 2021-04-12 burning sensation raised rash/welts on left forearm & upper arm (I got the shot in my left arm). I also had a raised ... Read more
raised rash/welts on left forearm & upper arm (I got the shot in my left arm). I also had a raised rash on my right forearm. (My arms were itchy with a bit of a burning sensation. The PA thought that I also had a rash on my upper back, but I didn't feel any itching or pain. I went to the local urgent care & received steroids & Benedryl. The rash diminished rather quickly, but re-emerged on the next morning.
56 2021-04-12 cold sweat Immediately after receiving vaccine, patient reported to feeling lightheaded and felt like passing o... Read more
Immediately after receiving vaccine, patient reported to feeling lightheaded and felt like passing out. APN assessed patient and stated initially patient was pale in face and felt clammy. About 5-10 minutes later, patient had normal color and stated she felt better. Patient sent to waiting area with EMS for an additional 15 minutes of monitoring.
56 2021-04-12 numbness, tingling, burning sensation Burning numbing and tingling on the left side of my face. Which traveled down my neck and then to m... Read more
Burning numbing and tingling on the left side of my face. Which traveled down my neck and then to my left arm. Still partially numb at this point which is three weeks later. The left side of my face is still very stiff feeling
56 2021-04-12 numbness 3/30/21 DAY AFTER SHOT HAD THE NUMBNESS IN LEFT SIDE OF FACE. 4/2/21 - 4 DAYS AFTER I GOT A RASH ON ... Read more
3/30/21 DAY AFTER SHOT HAD THE NUMBNESS IN LEFT SIDE OF FACE. 4/2/21 - 4 DAYS AFTER I GOT A RASH ON MY NECK AND CHEST. BOTH SIDES. I TOOK BENADRYL FOR 5 DAYS WENT TO CLINIC ON MONDAY (4/5/21) AND THEY SAID IT WAS A REACTION TO SHOT. RASH WAS GONE BY THURSDAY.
56 2021-04-12 migraine Rash all over, redness, fever, chest pain and heaviness, fainting, severe itching, sore throat with ... Read more
Rash all over, redness, fever, chest pain and heaviness, fainting, severe itching, sore throat with blisters in mouth, Migraine, and HBP. Treatment: ER-IV Solu-medrol X1, Pepcid x1, Fiorcet x1, Toradol x1, Caffeine pill by mouth.
56 2021-04-12 pain in extremity I was woken up to inability to straightening my left leg and strong left leg pain around the knee. I... Read more
I was woken up to inability to straightening my left leg and strong left leg pain around the knee. I had trouble walking and pain while walking. This lasted 12 hours and then stopped
56 2021-04-12 pain in extremity allergic reaction/Allergic anaphylactic reaction; lungs were filling up with fluid; throat was closi... Read more
allergic reaction/Allergic anaphylactic reaction; lungs were filling up with fluid; throat was closing; Main trouble is breathing and is out of breath; legs sore; Throat sore; Cough; hard for her to walk; tired; trying to swallow a tablet and digest it and it gets stuck; trying to swallow a tablet and digest it and it gets stuck; breathing was heavy; choking; trying to swallow a tablet and digest it and it gets stuck; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 24Mar2021 (Lot Number: ER2613) as a single dose for to prevent COVID (covid-19 immunisation). Medical history included having blood clot from 2019 to Mar2021 which the patient stated a couple of weeks ago (Mar2021), she had an ultrascan in her leg and the blood clot was not there, but she is on medication. The patient has recovered completely from blood clot (not ongoing). Concomitant medication included warfarin (WARFARIN) to prevent from having blood clot ongoing since Jun2019. The patient previously took gabapentin for pain but had throat started closing, allergic reaction, coughing and was intubated until she was released from hospital; and albuterol [salbutamol] for dyspnoea but had nebulizer to open up her airways and prevent closing and did not work (drug ineffective). The reporter mentioned that the patient ended up in the ICU because of the COVID vaccine. As soon as the vaccine was administered within seconds, the patient experienced a reaction and was given an epi pen, another epi pen even an epinephrine drip and was sedated and intubated. The reporter mentioned that they gave the patient the first shot of epi pen and it did not work, and she was given a second one and a third one plus steroids. By the time the ambulance people arrived, they hooked the patient up to an IV and gave her additional epinephrine and administered another epinephrine. The ambulance guy told her; she does not need to keep up with them because they needed to go to the hospital ASAP because the patient is not getting better but getting worse. Once the patient got to hospital, she was intubated because her throat was closing. The reporter stated that the patient has allergies to begin with and this was worse than the first time she had to be intubated. The epi pens did not work, the patient was intubated and then had to be sedated. The patient was on Propofol in order to sedate her and later on in the evening was given Fentanyl to relax her then the epinephrine drip was removed at 6 pm on 24Mar2021. The epinephrine drip was started in the emergency room and the patient could not be moved to the intensive care unit until she was somewhat stable. The patient was moved to the intensive care unit and was there overnight and by the time next morning she was able to be extubated where they removed the tube from her around 9:30 to 10:00 25Mar2021. Of course, the patient was taken off Propofol, but she went through a lot and her legs are sore, throat is sore, and is coughing on 25Mar2021 because of the side effects from being intubated and that she went through a lot. The intensive care unit doctor said that the patient can no longer have the vaccine and she would only be 70% protected till whenever they are not sure how long the vaccine will last. The adverse events almost took the patient's life which made the reporter angry at that. The reporter is not sure what the contents in the vaccine that it in the other drugs and vaccines since there is something that is contained in all of them and the patient was not allowed to have any whether it is the Pfizer or Moderna and it is even up for discussion for even the flu shot because of the reaction and there does not want to be any chances and that everything should be proceeded with caution. The reporter wanted to know what is in the COVID 19 vaccine to see about what could have caused the allergic anaphylactic reaction. The reporter stated and the fact that the epi pen did not work, she was taken aback. The reporter added that the doctor had a hard time intubating because of her throat but they were able to intubate from the second time. The reporter stated that it is taking a while but her wife is recovering and feeling it is taking a while taking a little bit longer. The reporter also stated that they kept the patient in the intensive care unit overnight and after the tube was removed in the morning, by the late afternoon she was moved to a different floor to continue to be observed and the intensive care doctor said 2 days out her wife would be safe to go. The patient stood up but it was hard for her to walk on 25Mar2021 because it could have been from the epi pen, but she is not sure. The patient stated the side effect came out of the allergic reaction and it was on Thursday 25Mar2021. Patient stated the main trouble is her breathing, she is out of breath still and really sore throat on 25Mar2021. The patient stated that the leg sore is still ongoing and is about the same. It was mentioned that the throat sore was still ongoing but some days are worse and some days are better. The patient stated that when she has a problem trying to swallow a tablet and digest it and it gets stuck on Mar2021. It was stated that the cough was not going away. The cough comes and goes away. She will cough for five minutes constantly and then it disappears then she will fall asleep and wake up coughing. It's as if she is choking (Mar2021). When she is talking, she coughs more. With regards to the allergic anaphylactic reaction, the patient stated she is experiencing the aftereffects of the allergic reaction and being intubated like being out of breath. The patient stated that will come in time and that's what happens when she gets intubated. Her breathing was heavy and comes back fully with rest on Mar2021. This has taken a lot out of her. She was feeling tired which was still ongoing it is about the same but comes and goes on 25Mar2021. The patient is experiencing lingering side effects and the patient does not feel as if she has recovered completely. It was also mentioned that the patient was intubated on 24Mar2021 to 25Mar2021. It was reported that treatment of the patient included Epi Pen, Epinephrine Autoinjector USP 0.3 mg (Epinephrine injection manufacturer was Mylan) which the patient was given at least three injections (two in the right leg and 1 on the left) then received another in the ambulance (unknown site). Patient received an Epinephrine drip and it was like 0.1 mg all the way up until 6 pm (only on 24Mar2021). The epinephrine drip was started when patient was intubated at the hospital. It was given for patient's allergic reaction through IV. The patient's lungs were filling up with fluid so her airway was restricting her from breathing and to prevent damage of the lungs that is when the intubation came in. The patient also received Prednisone which the reporter does not recall when this medication was started it may have been after the epinephrine drip was removed but she is not sure if they started the prednisone after or if it was the same evening which the reporter kind of thinks it was. The reporter stated that the patient took Propofol 24Mar2021 to 25Mar2021 which was given through the patient's IV and was given to help her airways being intubated, they sedate their patients. The patient also received fentanyl which must have been added either right before Epinephrine drip was removed or after but reporter does not recall. Patient was given Fentanyl 24Mar2021 to 25Mar2021 through her IV. Patient received this medication to relax because sometimes it is like some patients tend to want to sit up and kind of hear you, hear what people are saying and to relax patient sometimes because they can get scared and not exactly sure what is going on. The events anaphylactic reaction, pulmonary oedema, throat constriction and breathing difficult. The patient underwent lab tests and procedures which included lung was checked from a CT scan was unknown results on 12Jun2019, D dimer test was elevated on an unspecified date, ultrascan in her leg (ultrasound scan) blood clot was not there on Mar2021 and weight was probably weighs 180 or her weight may be a little less like 175 on an unspecified date. The outcome of the events anaphylactic reaction and throat constriction were recovering, as for the events leg pain, throat sore, cough and tiredness were not recovered while the outcome of the other events was unknown.
56 2021-04-12 pain in extremity Day 1-2 - Sore arm and injection site Day 1 -4 - Mild headache, somewhat lathargic Day 7 - 14 ... Read more
Day 1-2 - Sore arm and injection site Day 1 -4 - Mild headache, somewhat lathargic Day 7 - 14 - Swollen and sore left arm, forearm, hand, wrist into thumb; Sore left shoulder and left back/shoulder. Several lumps in neck, approximately 3 - 4, diagnosed by doctor as Lymphadenitis.
56 2021-04-12 tingling swollen glands, sore throat, tingling on rt side of leg
56 2021-04-12 speech disorder 24 hours later I became unable to communicate with anyone human for about 3 hours.
56 2021-04-12 tremor Immediately after vaccine administration felt dizziness and shaking
56 2021-04-13 weakness Woke around 5:30 am the morning after the 2nd shot with chills and body aches. Had severe fatigue, ... Read more
Woke around 5:30 am the morning after the 2nd shot with chills and body aches. Had severe fatigue, joint and muscle aches all day. Took ibuprofen every 5 to 6 hours. The 2nd day after the shot, no chills, but continued fatigue and body aches although better than the day before (continued taking ibuprofen). The 3rd day, swollen and tender lymph nodes under my left arm and over my left clavicle. Lymph nodes continue to be swollen and tender 5 days after shot. Energy level has returned to normal and body aches are gone.
56 2021-04-13 burning sensation, pain in extremity I HAD THE PFIZER VACCINE ADMINITERED AT FACILITY ON 3/31/21. THIS WAS THE FIRST DOSAGE. ON DAY 5 I H... Read more
I HAD THE PFIZER VACCINE ADMINITERED AT FACILITY ON 3/31/21. THIS WAS THE FIRST DOSAGE. ON DAY 5 I HAD PAIN IN MY LEFT LEG FROM GROIN TO CALF. BY DAY 5, I BEGIN TO LIMP, MY LEG WAS BURNING, INCREASED PAIN AND I COULD FEEL WHAT I BELIEVE TO BE BLOOD CLOTS AND MY LYMP NODE IN MY LEFT GROIN FELT SWOLLEN. OVER THE COURSE OF 2 DAYS, THE PAIN BECAME WORSE. I CONTACTED MY DOCTOR AT FACILITY FOR A TELEPHONE INTERVIEW IN REGARDS TO WHAT I STATED ABOUT THE PAIN. CLOTS, SWOLLEN LYMP NODES ETC.. AND EXPLAINED THAT THIS OCCURED AFTER OBTAINING THE COVID-19 VACCINE. I WAS ADVISED TO HAVE A DOPPLER PERFORMED AT THE ER. I WENT TO THE ER LATER THAT EVENING AND WAS TOLD THAT DOPPLERS WERE NOT COMPLETED AFTER 4 P.M. BLOOD WORK WAS PERFORMED BY HOSPITAL. MY LAB WORK WAS NORMAL AND I WAS ADVISED THAT I WOULD BE CONTACTED THE NEXT MORNING FOR AN APPOINTMENT FOR THE DOPPLER. ON 4/8@1:00 PM, I HAD THE DOPPLER PERFORMED AT HOSPITAL. I WAS TAKEN BACK TO THE ER AND WAS INFORMED THAT I HAVE DVT AND THIS WAS POSSIBLY LIFE THREATING. I HAD NO PRIOR HISTORY OF CLOTS. I'M CURRENTLY TAKING ELIQUIS FOR THE BLOOD CLOTS, WEARING A COMPRESSION GARMENT AND TYLENOL FOR PAIN. I WAS ADVISED TO HAVE ANOTHER DOPPLER COMPLETED IN 6 MONTHS
56 2021-04-13 difficulty speaking, tingling chest pain, shortness of breath, dizzy, exhaustion, tingling in rt leg and arms, hoarse voice, diffi... Read more
chest pain, shortness of breath, dizzy, exhaustion, tingling in rt leg and arms, hoarse voice, difficulty walking,
56 2021-04-13 feeling jittery My heart rate has been elevated on a continual basis since getting the 2nd dose. I have shortness o... Read more
My heart rate has been elevated on a continual basis since getting the 2nd dose. I have shortness of breath, constant jitters and an erratic heart beat (skips beats). It is constant and does NOT go away. I have not ingested any stimulants (coffee, food, medicine, etc) of any kind over the past month.
56 2021-04-13 muscle twitching, numbness About 30 minutes after receiving the shot my pinky and ring finger on my left him again to go slight... Read more
About 30 minutes after receiving the shot my pinky and ring finger on my left him again to go slightly numb. That was followed by my pinky finger lightly twitching for about 40 minutes. About three hours later there is just a mild numbness but the twitching has stopped.
56 2021-04-13 tingling Patient received COVID vaccine (Pfizer) dose 1 and afterwards experienced heartburn, tingling in bot... Read more
Patient received COVID vaccine (Pfizer) dose 1 and afterwards experienced heartburn, tingling in both arms, and developed tongue/hard palate discomfort immediately following the vaccination and states BP was elevated. Patient had vitals taken and noted systolic BP 205, then RRT called and taken to the ED for further monitoring. In the ED patient had CBC, CMP, and Troponin drawn and no abnormalities seen and EKG was normal. Patient was monitored and then discharged home from the ED.
56 2021-04-13 tingling Pins and needles in arms and legs
56 2021-04-14 weakness, flushing Had a flush/rush in chest like water running through me about 5 minutes after receiving the vaccine.... Read more
Had a flush/rush in chest like water running through me about 5 minutes after receiving the vaccine. Then started to feel dizzy/weakness as if I was going to faint. I didn't tell the nurse on hand until 25 minutes later as I thought these were normal so I was asked to stay another 30 minutes after they took my pulse and BP. All was normal. But still felt weak. Stayed an hour then left. Felt odd, not myself., out of sorts....went home, felt ok for an hour, then started feeling tired and fatigued...fell asleep and had diarrhea at night. Yesterday slept in, had one episode where I felt off and felt like I couldn't breath which lasted for a couple minutes. Feel ok today.
56 2021-04-14 feeling cold Severe pain in arm at 5AM, nausea and very cold that I had to get up and put on my winter pajamas. ... Read more
Severe pain in arm at 5AM, nausea and very cold that I had to get up and put on my winter pajamas. I took a Tylenol and went back to bed. Woke up at 7AM, still the same now light chills, overall feel like I have a flu coming on.
56 2021-04-14 hot flush Extreme headache, lethargy, stomach pains, chills, hot flashes, nausea
56 2021-04-14 pain in extremity, feeling hot Hot rash, headache, nausea, diarrhea, arm pain, heat and swelling at injection site, muscle aches, f... Read more
Hot rash, headache, nausea, diarrhea, arm pain, heat and swelling at injection site, muscle aches, fever, sore throat, dizziness
56 2021-04-14 pain in extremity Both arms with unbearable muscle pain, nausea, diarrhea
56 2021-04-15 inability to speak Patient's husband reported to the pharmacy that she was having a hard time breathing. When I reache... Read more
Patient's husband reported to the pharmacy that she was having a hard time breathing. When I reached the patient she had already taken two puffs of her albuterol inhaler. She said it felt like her throat was closing so 911 was called. She continued to labor in her breathing and said her lips were tingling. She was no longer able to talk and she took one more puff of her albuterol inhaler. Then she began gasping and an epinephrine 0.3mg pen was administered. Paramedics arrived and took her to the hospital.
56 2021-04-15 feeling cold Chills severe, tiredness ~ I had 2 throw blankets, 1 thermal blanket doubled, long sleeve blouse, lo... Read more
Chills severe, tiredness ~ I had 2 throw blankets, 1 thermal blanket doubled, long sleeve blouse, long pants, slippers, a space heater directed at me, the temp in the house was 72 and I was still freezing. Finally, I put my head under the covers and slept for hours. I woke up around 10:00PM and went to bed. I wasn't freezing, at that time, but I wasn't hot either and slept with 2 blankets (1 was a weighted blanket) all night. I woke with a headache, but took 2 Tylenols and felt better after 30 minutes. I'm feeling well now, but I don't think I will get the 2nd vaccine.
56 2021-04-15 feeling hot Nauseousness came in a wave, very hot sweating, could see perspiration, very very dizzy, increased B... Read more
Nauseousness came in a wave, very hot sweating, could see perspiration, very very dizzy, increased BP
56 2021-04-16 weakness 1st Pfizer shot on march 26. Started feeling dizziness, weakness and Vertigo on march 31 all day at ... Read more
1st Pfizer shot on march 26. Started feeling dizziness, weakness and Vertigo on march 31 all day at work. Went to ER on April 2. Blood work, EKG, are ok. Blood pressure was elevated so I was kept on monitor for several hours. Had a Brain MRI done which I have to see a Neurologist for due to white spots found. Was given 25mg Meclizine prescription and released. Saw Primary Doctor on April 15. He said to have 2nd shot as scheduled for April 18th. Will be seeing Neurologist on April 22. Never existed from Vertigo before.
56 2021-04-16 numbness Facial numbness; Puffiness; This is a spontaneous report from a contactable consumer . A 56-years-ol... Read more
Facial numbness; Puffiness; This is a spontaneous report from a contactable consumer . A 56-years-old female patient received the second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0142 and expiry date was not provided), via an unspecified route of administration, administered in Arm Left on 04Jan2021 15:30 as single dose for COVID-19 immunisation. Medical history included Early menopause, hypothyroidism from Oct2020 still ongoing and Pollen-Seasonal allergies, Sinus congestion. The patient previously took first dose of historical vaccine BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EH9899 and expiry date was not provided), via an unspecified route of administration, administered in Arm Left on 14Dec2020 15:30 as SINGLE DOSE for covid-19 immunisation and experienced Facial Numbness, swelling, flushed, Extreme fatigue 24 hrs after vaccine, multi joint pain, Also felt 'a little bit' of nausea, Funny- Brain fog. Concomitant medications included estrogens conjugated (PREMARIN) taken for premature menopause as 0.625mg Daily, levothyroxine sodium (SYNTHROID) taken for hypothyroidism as 50mcg daily in Am with water 30minutes prior to eating. Past drug event included Codiene(CODEINE) which causes nausea and cetirizine hydrochloride(ZYRTEC) for seasonal allergies. patient was given antihistamines; Zyrtec 1/2 tablet daily for seasonal allergies.On Jan2021, the patient experienced facial numbness and puffiness. Treatment received for the events reported. Outcome of the events was unknown.
56 2021-04-16 pain in extremity I started having pain under my armpit and some swelling, then pain went up to my armpit and swelling... Read more
I started having pain under my armpit and some swelling, then pain went up to my armpit and swelling that it hurt when I have my arm next to my body! It disturbed my sleep and my daily comfort I had to keep my arm away or on a pillow at night. For two days I used heated pad and took the supplement Oregano oil (1 capsule/day) as I suspected it was my lymph glands, the third day the pain was slight in my armpit and felt a little pain in my left shoulder blade.
56 2021-04-16 pain in extremity 3 weeks of headaches (never get headaches that last more than a day), right leg calf pain still has ... Read more
3 weeks of headaches (never get headaches that last more than a day), right leg calf pain still has not stopped. Had a calf sonogram told to get another one in 10 days. I had blood work done 4 weeks prior to First Pfizer shot and again 2 weeks after. MCHC went HIGH, Monocytes went to HIGH, ANION Gap was HIGH, BUN went to HIGH and Glucose went to HIGH. I have been having all these blood test other than ANION Gap every 6 months since 2015 and they have always been in the normal range. Feeling of being dehydrated and new joint pain.
56 2021-04-16 pain in extremity I have a very swollen left leg. It began slowly and became worse. I thought that I sprained my lef... Read more
I have a very swollen left leg. It began slowly and became worse. I thought that I sprained my left knee on March 13th. (I had my first vaccine shot in my left arm on March 11th. ) I thought that I would let it heal. My second shot was April 1st and my left leg became very painful after that. I went to the Doc. for a knee sprain, was sent to Orthopedic. I received an X-ray and an MRI. There is tricompartmental osteoarthritis, with 2 degenerative meniscus tears. It occurred to me today that my knee joint may be reacting to the vaccination. I did have swollen lymph nodes on my left side in neck and under my arm after the second shot. My knee has had arthritis and possibly the degenerative meniscus tears but it has never become swollen and inflamed. The swelling and pain has persisted for over 2 weeks now. I?m not sure if it is related but I thought that I should share this with you. If there is anything that you can help with, please do. I have been so very grateful for the vaccination. Thank you!
56 2021-04-16 pain in extremity It hurt more than 1st shot at time of shot. It was higher up on the arm, an inch from my shoulder. T... Read more
It hurt more than 1st shot at time of shot. It was higher up on the arm, an inch from my shoulder. Throughout the day, the pain mildly increased. By 5pm, I couldn't lift my left arm, pull up my pants, extend my arm. The pain radiated up my shoulder and is excruciating. I had fun plans for today that I had to cancel. That is not me. I suffer through. I can't carry a light blanket with left arm at this time.
56 2021-04-16 tingling Within 5 minutes after the injection I felt drugged, foggy headed, down in mood, a hum, buzz, tingli... Read more
Within 5 minutes after the injection I felt drugged, foggy headed, down in mood, a hum, buzz, tingling type feeling through out my body, slowed down reactions and reflex?s, glad to know my husband was with me to drive me home. I didn?t feel confident after the injection to trust my reactions with driving. Which was totally unexpected to happen so soon. Later that evening had the usual chills and achiness. It?s now 2 days later and I?m still foggy headed and tired. None of this is life threatening but it could have been if I tried to drive. Which is my point in filling this out. No one mentioned this could happen so quickly.
56 2021-04-18 weakness, discomfort I am reporting these symptoms in the hopes it helps others. Injection site pain and swelling start... Read more
I am reporting these symptoms in the hopes it helps others. Injection site pain and swelling started 3 hours after injection and lasted 4 days, minor pain now if press on muscle. Beginning 4/11 until present tiredness, no energy, minor difficulty concentrating and remembering how to say things. I thought at first needed good night sleep, it gets worse towards end of the day. Beginning 4/14 muscle pain began on my lower back and began to move up as the day progressed, became uncomfortable to sit for more than 1 hour. Over weekend extended to legs and neck. On 4/19, Monday night 6:30pm muscle pain over all body, slight headache that comes and goes more annoying then anything, feeling a little warmer than usual, no fever. There is no muscle pain if I do not move. I'm resting, in bed, drinking water, appetite not affected. I am scheduled for the second dose on 4/30 . May this information be helpful. Thanks!
56 2021-04-18 weakness Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spont... Read more
Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6208, expiration date: 30Jun2021) via unspecified route of administration in right arm on 25Mar2021 15:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Patient medical history included Guillain Barre syndrome on Feb2017 and asthma on unspecified date. Concomitant medication included ongoing IVIG treatment, unspecified (one infusion every four weeks) for Guillain Barre syndrome. The patient previously received first dose of bnt162b2 (lot number EN6201) on 04Mar2021 at the age of 56-years-old for covid-19 Immunization, and experienced sore arm. On 25Mar2021, after the second dose of the vaccine, the patient felt really lousy. The patient was fatigued on unspecified date in Mar2021. On 29Mar2021, patient had lower abdominal pain and low grade fever. The left side has been the side that has been impacted by Guillain Barre syndrome CID and that was the side that was affected after the vaccine. On 28Mar2021, the patient experienced weakness; was too weak to care for herself and she and her husband decided to go into the hospital. The patient was admitted on 28Mar2021 by neurologist (for the event weakness) and she stayed 2 nights and then came home 30Mar2021. The patient had been tired and weak since discharge from the hospital. The patient was on a monthly course of IVIG but the round she got in the hospital was exactly 2 weeks in-between her scheduled monthly treatments. Complete fatigue and weakness were still ongoing. The patient also experienced double vision on unspecified date in Mar2021 which was ongoing, but this was something that starts flaring up with her condition. The patient's low grade fever experienced on 29Mar2021 lasted for 3-4 days. The patient has gone backwards in her Guillain Barre syndrome since she had the vaccine, her opinion is that this was a set back she is not sorry she got the vaccine and is grateful for it. Events resulted in emergency room visit and Physician's office visit. Outcome of the events (weakness, fatigue and double vision) was not recovered. Event (Lower abdominal pain) was recovering; event (low grade fever) was recovered on unspecified date (lasted 3-4 days); while outcome of event (felt lousy) was unknown.
56 2021-04-18 facial pain 7.5 hours after receiving the Covid19 Vaccine, my nasal passages started burning. After about 30 min... Read more
7.5 hours after receiving the Covid19 Vaccine, my nasal passages started burning. After about 30 min of my nasal passages burning (they continued to burn), I had a sudden onset of severe pain across my face in my sinus's. My upper teeth were also in pain. I could not drink anything hot or cold because it would cause a sharp shooting pain through my sinus's and would take several mins to subside. The pain continued the next day, so I went to immediate care but they refused to give me an antibiotic. They gave me a Covid test which was negative. 4 days after the extreme pain in my sinus's and teeth, I still had severe pain on the left side of my face, ear and teeth. I called my primary care physician and she prescribed a 10 day Augmentin antibiotic. Finally my pain subsided 7 days after my vaccine (3 days after the start of antibiotics). 2 days after I finished the antibiotics, I had a sudden onset of severe pain in my hips and lower back, the pain persisted for a week. I went for acupuncture treatment and this eased my pain. I just had my 2nd dose of the Covid19 vaccine and did not have any side effects.
56 2021-04-18 facial paralysis, difficulty speaking, numbness Her voice was hoarse and raspy; She had about 10 canker sores in her mouth.; Facial paralysis; Her l... Read more
Her voice was hoarse and raspy; She had about 10 canker sores in her mouth.; Facial paralysis; Her left calf felt numb; She said she saw more wrinkles on her face than she knew she had; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Pfizer product, lot: EP7534) in left arm on 23Mar2021 17:30 at a single dose for COVID-19 immunisation. Vaccination Facility Type was Hospital. Medical history included ongoing genital herpes. Concomitant medications included valaciclovir hydrochloride (VALACYCLOVIR HCL) 1gram tablet for genital herpes. Stated she had genital herpes for over 10 years, and had an outbreak about 2 weeks prior to getting her 1st COVID-19 Vaccine. She said she hadn't had a herpes outbreak in over 10 years. She said she stopped taking her Valtrex medication after the COVID-19 Virus Pandemic started. She said she restarted the Valtrex when she had the genital herpes outbreak a couple weeks before her 1st COVID-19 Vaccine. She said she had taken a 1/2 Valacyclovir 1gram tablet, off and on, to treat her recent. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. Patient experienced her left calf felt numb on 23Mar2021 with outcome of recovered/resolved; the skin from under both her eyelids to her cheek bones felt like it was being pulled down on 23Mar2021 with outcome of recovered/resolved; her voice was hoarse and raspy on 24Mar2021 with outcome of not recovered/not resolved; she had about 10 canker sores in her mouth on 24Mar2021 with outcome of recovered/resolved; facial paralysis on 23Mar2021 with outcome of recovered/resolved; her skin felt tight on 23Mar2021 with outcome of recovered/resolved; She said she saw more wrinkles on her face than she knew she had on 23Mar2021 with outcome of unknown; cholesterol was high on an unspecified date in 2021 (either late Feb2021 or early Mar2021) with outcome of unknown. She is asking for a recommendation on receipt of second dose. Clinical course: patient reported she had her first COVID-19 Vaccine shot last Tuesday (23Mar2021), and she had some side effects that were not listed on the COVID-19 Vaccine information sheet she was given. She said she was concerned about getting the second COVID-19 Vaccine shot. She said she sat for 15 minutes after she received her COVID-19 Vaccine, and was completely fine. She said she then had about a 5 minute walk to her car. She said when she was walking to car, her left calf felt numb. She said at first she thought maybe she had been sitting too long, and her left leg fell asleep. She said once she got to her car, the skin from under both her eyelids to her cheek bones felt like it was being pulled down. She described the feeling as being in the sun for days, saying her skin felt tight. She said she looked in her car mirror. She said her face wasn't red, but her face definitely looked like it was being stretched. She said she saw more wrinkles on her face than she knew she had. She clarified her face being stretched as a facial paralysis, and said the facial paralysis only lasted about 4 hours, and then disappeared. She said the next day (24Mar2021), she woke up, and her voice was hoarse and raspy. She said her voice continued to be hoarse and raspy for 2 weeks now. She clarified the hoarseness had been on and off and had improved from last week, but in the evenings her voice gets raspy. She said she had about 10 canker sores in her mouth. She said she gargled with Scope, and the canker sores would come and go. She said the canker sores were not painful like canker sores, but were just sores. Reported she had blood work done in either late Feb2021 or early Mar2021, and everything was fine, except her cholesterol was high. No further details provided. Treatment: Reported she spoke to the on-call doctor at her doctor's office on 23Mar2021 first, and then called the (name) Hospital Emergency Room and spoke with someone about her side effects on 23Mar2021. She said the doctor on-call at her doctor's office told her to take a 1/2 tablet of Valtrex (clarified as generic Valacyclovir HCL 1gram tablet). She clarified she had been taking Valacyclovir HCL since she was diagnosed with genital herpes about 10 years ago. She said she stopped taking the Valacyclovir HCL when the COVID-19 Pandemic started last year. She said she restarted the Valacyclovir HCL, taking a half Valacyclovir HCL 1gram tablet (500mg) daily. She said she spoke with her gynecologist today (02Apr2021), and he told her to take the full Valacyclovir HCL 1gram tablet for 3 months and then go back to taking a half Valacyclovir HCL 1gram tablet (500mg). She said the Valacyclovir HCL 1gram tablet was dispensed in a pharmacy bottle, providing NDC Number: 1671469701. She did not have a Lot Number and Expiration Date. She said the generic Valacyclovir HCL 1gram tablet was manufactured by NorthStar Rx and had "(3/3)" after the manufacturer's name. Reported she gargled with Scope mouthwash for her canker sores in her mouth. She said she had finished the Scope mouthwash, and disposed of the product bottle, and didn't have the UPC, Lot and Expiration Date. Reported her gynecologist was the one who told her to call Pfizer to get further direction about getting her second COVID-19 Vaccine. Follow-up attempts are completed. No further information is expected.
56 2021-04-18 migraine, feeling cold, hot flush 17 hours after shot fever as high as 103, chills, body aches , severe migraine like headache for 24... Read more
17 hours after shot fever as high as 103, chills, body aches , severe migraine like headache for 24 hours , followed by another 24 hours of internal heat similar to hot flash but continuous , sweating and resting heart rate 107 -110, hot urine , normal blood pressure & temperature. Dry cough . Two days later I got a period. I?m 56 and hadn?t had a period in almost a year. Blood was heavy and dark in color. Still bleeding but lighter it?s been 6 days.
56 2021-04-18 night sweats, tremor Cloudy urine 11+ days Smelly urine 11+ days Orange urine 9 days Body Temperature fluxuations 10 days... Read more
Cloudy urine 11+ days Smelly urine 11+ days Orange urine 9 days Body Temperature fluxuations 10 days Achy back 11+ days Fever over 102.1 2+ days Vomiting 2 days Shaking Chills 10 days Night Sweats 11 days Shakiness 10 days Slowness10 days Stiffness 10 days Unsteadiness 10 days Extreme Fatigue 11 days Diarrhea 2 days
56 2021-04-18 pain in extremity The onset of symptoms began 10 hours after the second dose injection, including severe headache, fev... Read more
The onset of symptoms began 10 hours after the second dose injection, including severe headache, fever, arm pain, fatigue, and tinnitus. All symptoms persisted intensely for 24 hours, then started to lift -- with the exception of headache and tinnitus. The headache resolved at about 48 hours. Tinnitus remains severe and consistent since the day of the shot. No prior history of tinnitus or auditory disorder.
56 2021-04-18 pain in extremity pretty severe headache within three hours fatigue within three hours next morning headache, dirrehea... Read more
pretty severe headache within three hours fatigue within three hours next morning headache, dirrehea and nausea symptoms gone about 30 hrs after injection several days later developed mental fog felt out of sorts. lasted a couple of days Had exactly the same side affects on the second shot given 3/25/21 at the same facility. symptoms less severe in nature but lasted a little long. Severe arm pain not necessarily at the injection site but same arm.. Woke me up with pain if I accidently moved or touched it while sleeping. All resolved in 48 hours of vaccine.
56 2021-04-18 seizure Received vaccine at 12:30 p.m. on Thurs., 4/15. By bedtime, I was experiencing body aches quickly fo... Read more
Received vaccine at 12:30 p.m. on Thurs., 4/15. By bedtime, I was experiencing body aches quickly followed by severe chills and a splitting headache. Was awful. Lasted all evening. At 9:10 a.m. on Fri, 4/16, I had a seizure that I believe was caused by the vaccine since I haven't had a seizure for over a year (and the last one was triggered by a med change). After the seizure, my symptoms increased to include vomiting and nausea along with a severe headache. The vomiting stopped around noon. My headache lasted until Saturday morning. I felt okay Saturday, just a slight headache.
56 2021-04-19 weakness, tremor Woke up at 2am (approx 14 hrs after vaccine) with bad chills/shaking/sweating, fell asleep for a few... Read more
Woke up at 2am (approx 14 hrs after vaccine) with bad chills/shaking/sweating, fell asleep for a few hours then woke up feverish, bad headache, major bodyaches, nauseous with throwing up throughout the day, fatigue, weakness and sore arm at injection site so I slept most of the day in general, in between sickness. 2nd day after vaccine, April 15th I woke up with still a bad headache, bodyaches, nauseous, and sore arm. Headache subsided that night. April 16th I still was nauseous most of day and sore arm. Took extra strength tylenol a couple times on April 13th, 14th and 15th.
56 2021-04-19 nerve pain, burning sensation Zoster without complications Valtrex 1gm q8hrs for 7 days that has been extended for 3 more days du... Read more
Zoster without complications Valtrex 1gm q8hrs for 7 days that has been extended for 3 more days due to the persistence of the symptoms Symptoms: nerve pain, red rash, burning sesnsation at the left part of the brain/face (specifically on the left forehead, eye, chick, ear and scalp).
56 2021-04-19 nerve pain I was dizzy and rapid heartbeat after the injection but not bad enough for care. That receded after ... Read more
I was dizzy and rapid heartbeat after the injection but not bad enough for care. That receded after an hour or so, but then I had the worst herpes nerve pain down my legs that I've ever had. Took the acyclovir and mostly avoided the breakout, but felt bad for a few days. No fever. A week after the vaccination I started to feel dizzy on and off then 10 days or so later started having weird heart palpitations and pressure in my chest. I ended up in the ER. They said I wasn't having a heart attack but the condition has continued on and off as well as the dizziness. I also got a period 3 weeks after the shot having not had one for almost 2 years. I'm still not feeling well 4 weeks after the 1st shot with fatigue, intermittent dizziness and heart issues. I've been advised to hold off on the second shot. The dizziness was diagnosed as vertigo.
56 2021-04-19 pain in extremity, numbness Day after vaccine bilateral swelling of nose, 2nd day right side facial swelling, each day facial sw... Read more
Day after vaccine bilateral swelling of nose, 2nd day right side facial swelling, each day facial swelling would increase. Went to Urgent Care. Started immediately on Keflex and Deltasone. It took a week for the facial swelling and cellulitis to clear up. At the same time I was experiencing right and left hand numbness and finger tightness at night and AM. Can not make a fist or clench my fist together. The metacarpophalangeal was swollen and causing severe pain. Dr ordered CBC, CMP, Arthritis Profile, and ANA.
56 2021-04-19 pain in extremity I have constant tinnitus last 6 days and nights, since the April 14th. That is something new for me.... Read more
I have constant tinnitus last 6 days and nights, since the April 14th. That is something new for me. I had usual side effects; nothing significant. Arm pain and tiredness were the top two. I didn't pay much attention to tinnitus, but I noticed it the second night after the vaccine when I went to bed, and two more times after that, and it didn't last long. However, it started again 13 days after the vaccine, and the hissing sound is more lauder and constant. It is in both ears. It bothers me especially at night. It could be a coincidence, but it could be a vaccine side effect as well. I am afraid that the second doze could make this tinnitus worse.
56 2021-04-20 pain in extremity, tingling Achy legs starting with tight prickly feeling behind knees and thighs and progressing to achiness in... Read more
Achy legs starting with tight prickly feeling behind knees and thighs and progressing to achiness in entire leg from below buttocks and into feet. Finally contacted doctor on day 8 after feeling symptoms and heard back from him on day 11 (today). Use of 2-3 tablets of Advil twice a day with food for 3 - 4 days was recommended. This will only be started later this evening since I had tried taking Motrin this morning which did not seem to help.
56 2021-04-20 pain in extremity Severe fatigue, severe joint pain (hands, wrists, feet, hips, back), chills - lasted about 30 hours.... Read more
Severe fatigue, severe joint pain (hands, wrists, feet, hips, back), chills - lasted about 30 hours. Following these symptoms, a flat, red rash appeared around the injection site. The rash spread over one third of my upper arm and itched intensely (2.5% hydrocortisone cream was required to calm the itch). Rash began to fade after 72 hours, though itching remained another half day. Hand/wrist pain was overall worst symptom and has remained, though in milder form.
56 2021-04-20 tingling, numbness Tingling and numbness in left side of face and tongue
56 2021-04-21 cold sweat The second day at night when standing for more than 10 minutes I start to see blurred to cold sweat ... Read more
The second day at night when standing for more than 10 minutes I start to see blurred to cold sweat as if my blood pressure dropped and I feel like I am going to faint I have to sit or lie down immediately, I spent the second day after get vaccinated at night and today, which is the third day when I get up after standing for more than 10 minutes, on the second day I also had, a little fever, headache, pain in the body, chills and a little nausea Today the third day I only have a slight headache, and what I have felt is that I am going to faint after a while of standing.
56 2021-04-21 feeling hot, cold sweat Chills and then hot. Horrible headache. Very tired. Light sensitive. Clammy skin. I did not have a t... Read more
Chills and then hot. Horrible headache. Very tired. Light sensitive. Clammy skin. I did not have a thermometer but assume I had a fever. I was a little better on third day but headaches and sensitive to light lasted about 10 days.
56 2021-04-21 flushing Immediate: body flushing, racing heart (about 40-50 bpm higher than normal), and lightheaded/dizzy ... Read more
Immediate: body flushing, racing heart (about 40-50 bpm higher than normal), and lightheaded/dizzy Same day: tongue felt funny/slightly swollen Same day evening & next day: hives on upper and lower torso
56 2021-04-21 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
56 2021-04-21 tingling I had my first COVID-19 vaccine on March 12th. Shortly after the injection my shoulder began hurting... Read more
I had my first COVID-19 vaccine on March 12th. Shortly after the injection my shoulder began hurting. I thought it was just a side effect of the vaccine injection. However, after it was still hurting 2 weeks later, I found out it's because the injection was administered incorrectly. I had my second shot on April 2nd without any complications. My shoulder is still hurting from the first shot, and my arm and fingers are tingling. The intensity of the pain has gotten better over time but I still have pain in my shoulder and tingling in my arm and fingers. My concern is if the person gave my shot incorrectly, then she has given others shots incorrectly as well. I want to know if this is going to be an ongoing issue or if my shoulder will return to normal. I contacted the hospital and was told to report the problem to VAERS.
56 2021-04-21 tingling 55 y/o female, with no past medical history, who presents with Right arm tingling post vaccination. ... Read more
55 y/o female, with no past medical history, who presents with Right arm tingling post vaccination. Patient states that this is her first dose in the two-dose series. Patient denies previous vaccination reactions. Patient received her vaccination to the Right arm. Patient states that she also feels anxious and nervous. Patient denies sore throat, difficulty swallowing, chest pain or difficulty breathing. NP and Paramedics at patient side. Patient provided with a bottle of water and legs were elevated. Within 3 minutes patient stated that tingling resolved. Patient noted to be hypertensive (172/104) with all other vital signs normal. Patient denies medical history of hypertension. Patient moved to the partitioned off area and placed on cot. Patient vitals monitored every 5 mins for 1 hour. Patient became normotensive and stated that symptoms had resolved. Patient discharged home in stable condition.
56 2021-04-21 cold extremities, pain in extremity Nausea, sharp pain in lower calves, pain in temple, tight pressure around forehead, pain in lower le... Read more
Nausea, sharp pain in lower calves, pain in temple, tight pressure around forehead, pain in lower left back of head, slight temperature, lightheaded dizziness, swollen stomach and nausea, tightness in chest, rapid heart rate, ice cold feeling in feet, some chills, tight constricting feeling in neck.
56 2021-04-22 weakness Date and time adverse event started: 3/10/2021 at approx. 12:30pm, a few moments after rcvding the v... Read more
Date and time adverse event started: 3/10/2021 at approx. 12:30pm, a few moments after rcvding the vaccine. Pt reported that a few moments of rcvding the vaccine she felt pressure in her whole head, ears were clogged up, and had lumps in her throat; these symptoms lessen as the days goes by and she felt better by day 3. On day 4 (3/13/2021), pt reported she felt like she had a bad cold which turned into bronchitis and that lasted for 2 weeks that was accompanied by symptoms of stuffy head, stuffed up sinus and drainage, had low grade fever, and coughed up phlegm). Pt reported that she have history of tinnitus and post-nasal drips, the ringing in her left ear and the post-nasal drip was still ongoing prior to rcvding the COVID vaccine and these symptoms seems to have been exacerbated after she got the vaccine because she felt like it has gotten worse. Pt reported that she took otc Mucinex and Claritin on the 5th or 6th day from rcvding the vaccine. She went to see her PCP and got a chest x-ray (results: negative for any infections). Pt also reported she got tested twice for COVID-19 on 3/17/2021 & 3/23/2021 (results on both dates: negative). Pt reported that her PCP had advised her against getting the second dose. Advised pt that per her ADEs these are not a contraindication to getting the 2nd dose per CDC guidelines and per consulted Dr. The decision to get the second dose is up to her and her PCP. Advised pt that there is not knowing if the 2nd dose will make her tinnitus worse or if she will experience any ADEs. Also advised per CDC guidelines, "if it is not feasible to adhere to the recommended interval, the second dose of BioNTech COVID-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose. There are currently limited data on efficacy of mRNA COVID-19 vaccines administered beyond this window. If the second dose is administered beyond these intervals, there is no need to restart the series". 4/18-Patient feeling much better, symptoms have resolved with the exception of weakness and fatigue. Patient has taken Advil to help alleviate migraine. No longer has migraines. Caller called back to adv that she is still having tinnitus and post nasal drip from the 1st shot.
56 2021-04-22 bell's palsy Bell's palsy symptoms within 4 hours of shot.
56 2021-04-22 feeling hot 3:15PM PT GOT VERY 'WARM'. PLACED IN WHEELCHAIR; SYNCOPAL EPISODE/EYES ROLLED BACK APROX 30 SECONDS... Read more
3:15PM PT GOT VERY 'WARM'. PLACED IN WHEELCHAIR; SYNCOPAL EPISODE/EYES ROLLED BACK APROX 30 SECONDS. PLACED ON FLOOR, ELEVATED LEGS AND PT BECAME RESPONSIVE. PT GOT ONTO COT PER SELF. ELEVATED HEAD OF BED; DRINKING TEA. STATES SHE DID'NT HAVE MUCH TO EAT TODAY AS SHE WAS HAVING A DENTAL PROCEEDURE DONE THIS AM. BP 120/68, HR 60, R 20, 02 SAT 98%. A/O, PINK, W/D, RESP WITH EASE. 'FEELS MUCH BETTER NOW'. 3:45PM HUSBAND HERE TO DRIVE PT HOME. PT AMBULATORY TO EXIT- GAIT BRIS AND STEADY.
56 2021-04-22 flushing Client felt Flushed after injection of vaccine; B/P 152/88, 99% O2 sat on RA, HR 104 at 9:40am; B/P ... Read more
Client felt Flushed after injection of vaccine; B/P 152/88, 99% O2 sat on RA, HR 104 at 9:40am; B/P 132/88, O2 sat 99% on RA, HR 84 at 10:00am. Rested on couch, used the restroom, then left after feeling better. Stated she would have friend check on her that day.
56 2021-04-22 migraine I am peri menopausal, had missed my period for 2 months. The second day after the second dose my per... Read more
I am peri menopausal, had missed my period for 2 months. The second day after the second dose my period restarted with a very heavy cycle. Two days later I had an occular migraine for the second time in my life. It only lasted about 15 minutes. Otherwise, there were no other symptoms.
56 2021-04-22 pain in extremity Woke up morning after the vaccine with a fever of 101.4, head pounding and all over body aches; prim... Read more
Woke up morning after the vaccine with a fever of 101.4, head pounding and all over body aches; primarily in my back. Later that day I started having sharp stabbing pains in different locations in my legs. This continued for 2 days. I medicated with 3 motrin (200 mg pills) every 6 hours and piggybacked 2 tylenol (200 mg pills) at the 3 hour mark in between motrin dosages; my fever never came down. I remained achy, feverish, with headache and stabbing pains in my legs for entire 2 days. In the middle of the night, 3rd day after the vaccine going into the 4th day, I woke 5 times drenched in sweat. By the morning on the 4th day after the vaccine, my fever had finally broke and I felt better. A slight dry cough started the 4th day and has persisted into the 5th day. Additional note: I was diagnosed CoVid Positive (with symptoms) in October 2020.
56 2021-04-22 tingling Injection in left arm on Sunday, 3/28 - 4PM. By Tuesday, 3/30 - I stared feeling unusually / more t... Read more
Injection in left arm on Sunday, 3/28 - 4PM. By Tuesday, 3/30 - I stared feeling unusually / more than normal tired. By Thursday, April 1, 2021, symptoms of headache, body aches, extreme tiredness where all I wanted to do is sleep, depression, a bit of nausea continued and by 4/1 I had to go home from work. My lower calves (both legs) and ankles and feet were swollen, throbbing and felt like there were pin pricks / tingly sensation in my legs. I stayed home from work on that Friday, April 2, slept and slept. I tried to do minimal tasks that exhausted me - like wash dishes. I took aspirin - drank a ton of water and had lay with both legs elevated. By Sunday I was fine.
56 2021-04-23 facial pain TMJ problems jaw pain masseter muscular pain pain - all pain only on left side of face
56 2021-04-24 weakness This is a spontaneous report from a contactable consumer reported for self. This 56-year-old female ... Read more
This is a spontaneous report from a contactable consumer reported for self. This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient received her 1st dose of the Pfizer COVID vaccine earlier this morning. She mentioned that she had no allergic reaction but had experienced heavy dizziness, really bad weakness and tiredness, and muscle pains in the shoulders and arm the same day. She was feeling unwell and really tired to point of feeling like she's drunk. She drove 10 miles in her car on her way home from the vaccination facility and was struggling because of her symptoms, particularly the drunken feeling. She was asking if she needed to go to the emergency room. Patient was referred to HCP if symptoms persisted or if the patient felt the need to do so. The outcome of events was unknown. No follow-up attempts are needed. Information about lot/batch number can be obtained.
56 2021-04-24 feeling hot, burning sensation tightening sensation in throat air way restricting; tightening sensation in throat air way restricti... Read more
tightening sensation in throat air way restricting; tightening sensation in throat air way restricting; Taste in mouth followed by burning sensation throughout my body; Taste in mouth followed by burning sensation throughout my body; Turned red skin hot to touch; Turned red skin hot to touch; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (Brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm right on 13Apr2021 (Lot Number: EW0158) as single dose for COVID-19 immunisation. Medical history included asthma and high blood pressure. Known allergies: Sulfa drugs. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient was not pregnant. The patient's concomitant medications were not reported. If other vaccine in four weeks: No. The patient previously received first dose of BNT162B2 on 23Mar2021 01:15 PM (Lot number: ER5732), in left arm, at the age of 56-year-old for COVID-19 immunization. 1st shot hot spot red swelling at injection area. 2nd shot severe instant adverse reaction. The patient experienced taste in mouth followed by burning sensation throughout her body. Turned red skin hot to touch. Immediately followed by tightening sensation in throat air way restricting on 13Apr2021 at 01:45 AM. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment was received for the events which included Medics treated oxygen Dr administered Benadryl. The patient was recovering from the events.
56 2021-04-24 feeling of insects crawling on skin, numbness, pain in extremity, tingling Immediately after the injection, I experienced numbness and tingling down my entire left arm into m... Read more
Immediately after the injection, I experienced numbness and tingling down my entire left arm into my fingertips along with a heavy pressure sensation on my inner aspect of my wrist. My upper left arm felt incredibly sore and heavy for four weeks. It is over one month post injection, and my left thumb has lost 20% of its strength. My left hand constantly tingles, especially my thumb and pointer finger. I continue with random nerve impulses down my entire arm. It feels like spiders are crawling underneath my skin.
56 2021-04-24 pain in extremity, feeling cold, weakness Initially, arm soreness, But 16 hours after injection fever, bad headache, chills, fatigue, weakness... Read more
Initially, arm soreness, But 16 hours after injection fever, bad headache, chills, fatigue, weakness. Severe symptoms lasted about 12 hours. Minor ongoing for another 24 hours.
56 2021-04-24 pain in extremity chills; vomiting/wanted to puke; extraordinarily tired and dizzy like she was getting flu symptoms; ... Read more
chills; vomiting/wanted to puke; extraordinarily tired and dizzy like she was getting flu symptoms; extraordinarily tired and dizzy like she was getting flu symptoms; extraordinarily tired and dizzy like she was getting flu symptoms; diarrhea; Nauseous; felt dehydrated; she normally drinks coffee and it smelled nasty and she felt like she was eating a nickel everything tasted funny; felt like she was eating a nickel everything tasted funny; Sore Left Arm/Arm Pain 10 minutes later; felt like she was stung by bee; felt like a little sting; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 01Apr2021 11:39 as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure (diagnosed 4 years ago), ongoing high cholesterol (diagnosed 4 years ago), and ongoing asthma (diagnosed 10 years ago; she doesn't get it very often and if she does uses her nebulizer). Concomitant medications included losartan potassium from 2017 and ongoing taken for high blood pressure; lovastatin from 2017 and ongoing; hydrochlorothiazide from 2017 to an unspecified date for high blood pressure. The patient previously received flu vaccine and experienced no adverse effect. The patient experienced sore left arm/arm pain 10 minutes later (01Apr2021 11:49); felt like she was stung by bee, husband had no side effects. The next 2 days she felt fine and took Tylenol for her arm then 04Apr2021 in the morning, she normally drinks coffee and it smelled nasty and she felt like she was eating a nickel everything tasted funny. The patient got the first dose of the vaccine on 01Apr2021 and felt like a little sting the first 3 days, which she thought was normal and didn't have to take Tylenol. On the 4th day, 04Apr2021, she started feeling chills, vomiting, couldn't hold down food, extraordinarily tired and dizzy like she was getting flu symptoms, wanted to puke, couldn't get out of bed, and diarrhea. Today (unspecified date) was the first day she was doing little things. She asked if this is normal and if it could happen 4 days later and how long it will last? She asked if she should take Imodium for the diarrhea? She stopped hydrochlorothiazide for now because she felt dehydrated (04Apr2021) and wanted to keep fluid in her body. Also reported as three to four days later she started feeling nauseous, dizzy, chills and very very tired. She tried to drink water but things were not staying in her. The patient was asking is this a side effect that will go away or has anyone else complained about this? Caller stated it was almost like she had the flu. She didn't want to get out of bed. Her concern was the vomiting and diarrhea. Treatment: Zofran 4mg works for a little bit for nausea; Imodium, Tylenol. The patient clarified she normally gets up early in the morning and then couldn't get up because she was so tired. She took something for her nausea and got to bed and then tries to get up at 11:00a.m. Then of course she had chills and has been running the heater in the house and its 90 degrees outside, but she has had no temperature. Her stomach and chills were concerning to her. The patient stated her mom passed away 09Feb2021 from kidney failure. The doctor started her on Zoloft 50mg once a day, but she only used it for 2 weeks in February because she didn't like way she felt. States it is an antidepressant, but she was put on it because her father passed away then her mom passed 2 months later. She was also prescribed Xanax but she didn't take them either because she didn't like feeling like that. She was started on Wixela for her asthma, 250mg inhale 2 puffs twice daily but she hadn't use. No additional vaccines administered on same date of the Pfizer Suspect. No emergency room or physician office visit. She had read a lot about it and reactions from the vaccine; she wanted to know how long does it last and does she need to see the doctor? She tries to stay away from the doctor office because of Covid until she gets fully vaccinated. No prior vaccinations (within 4 weeks). The outcome of events arm pain, chills, vomiting, tired, dizzy, diarrhea, and felt dehydrated was recovering, nauseous was not recovered, the other events was unknown. No follow-up attempts are needed; No further information is expected.
56 2021-04-24 pain in extremity Arm hurts, arm heavy, feels sluggish , tired.
56 2021-04-24 pain in extremity The caller tested positive for COVID-19 yesterday; The caller tested positive for COVID-19 yesterday... Read more
The caller tested positive for COVID-19 yesterday; The caller tested positive for COVID-19 yesterday; Right arm sore; Body was sore for a week; Tired for a week; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female consumer (reported herself). The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via intramuscular in right arm on 18Mar2021 at 13:00 as a single dose for COVID-19 immunization. The patient's familial medical history included that the patient's son passed away 10Jun2020, he had type 2 diabetes. He went to hospital with Pneumonia and keep him for 3 weeks and released him and passed away the next day. The patient's medical history included soreness. The patient's concomitant medication included ibuprofen. On 18Mar2021, the patient experienced that in the morning when she woke up around 08:00the patient's body was sore for a week and she felt tired in the afternoon around 16:00-17:00. The patient's right arm was sore at 14:00, but not much. The patient went to work and used her arm and by the end of a day it was less sore and by the next day, it was almost normal. The patient's body was so sore, like doing exercise for a couple of days. On 18Apr2021, the patient was scheduled to receive her 2nd vaccine and patient tested COVID-19 vaccine and resulted positive so that the patient was sent to home. The patient would like to know when can get the second dose. Prior to the vaccination the patient received pills for high blood pressure. The patient did not received any vaccination 4 weeks prior to the COVID vaccine. The outcome of the events body was sore for a week, right arm sore and tired for a week was recovering and other events was unknown. No follow-up attempts are possible. No further information is expected.
56 2021-04-24 pain in extremity nose bleeds after first vaccine; Itching at first on arm then on body, after first vaccine; Soreness... Read more
nose bleeds after first vaccine; Itching at first on arm then on body, after first vaccine; Soreness of arm after first vaccine; swelling at the injection site; This is a spontaneous report received from a contactable consumer reported for herself. A 56 years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 12:00 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller stated that she did not have any side effects noticeable, but reported soreness in her arm lasted for 3 to 4 days, swelling at the injection site lasted for 3 to 4 days, which went away in a few days. Caller stated she did experience itching on her arm, but it was nothing she couldn't deal with. Caller reported that within a couple of weeks, on 01Apr2021, she started having nosebleeds. Caller stated she had a second nosebleed on 04Apr2021, and a third nosebleed on 06Apr2021. Caller added that she had one more, nosebleed, at 3 o'clock on 05Apr2021. Caller then reported she was experiencing the itching on her arm but then it became body itching, she cannot explain, it is hard for her to put into words. Caller stated it was not a rash but it feels like she had to scratch. Outcome of event pruritus was unknown, of others was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
56 2021-04-24 tingling, numbness immediate crushing feeling on same forearm; hand numbness/numb feeling up back, neck; hand numbness ... Read more
immediate crushing feeling on same forearm; hand numbness/numb feeling up back, neck; hand numbness and tingling; headache; seeing orange spots; faint feeling; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 56-years of age), dose 1 via an unspecified route of administration, administered in arm right on 26Mar2021 18:00 (Batch/Lot Number: EP7534) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date and unknown if ongoing. She had no covid prior to vaccination. She had not been tested post vaccination. Concomitant medications included calcium and cetirizine hydrochloride (ZYRTEC), and multivitamins, all taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient had not taken any other vaccine in four weeks prior to covid-19 vaccine. On 26Mar2021 18:00, the patient experienced immediate crushing feeling on same forearm, hand numbness and tingling, numb feeling up back, neck and headache; she was seeing orange spot; and she had faint feeling. The patient did not receive any treatment for the events. The outcome of the events was recovered with sequel.
56 2021-04-25 burning sensation Rash started on 4/16 on injection forearm and spread to right upper arm and shins. The rash itched ... Read more
Rash started on 4/16 on injection forearm and spread to right upper arm and shins. The rash itched and looked like clear blisters, burning sensation. Applied topical hydrocortisone cream. Severity over a week. Less severe now, but not gone.
56 2021-04-25 involuntary muscle movements One hour after receiving the vaccine, the patient started feeling poorly with some anxiety and what ... Read more
One hour after receiving the vaccine, the patient started feeling poorly with some anxiety and what appears to her to be some involuntary body movements she has no history of ms/neuro issues.
56 2021-04-25 pain in extremity Chills stated 04/25/2021 around 3:00am got up around 8:30am took Tylenol. Felt really tired all day ... Read more
Chills stated 04/25/2021 around 3:00am got up around 8:30am took Tylenol. Felt really tired all day some muscle ache sore arm. Took hot shower later that day took another Tylenol around 9:00pm and went to bed around 10:00pm. Woke up Monday morning around 6:15am felt much better.
56 2021-04-26 feeling cold Chills, fatigue, headache, body aches
56 2021-04-26 pain in extremity Persistent pain in my right calf getting my prominent. Wondering if its a blood clot.
56 2021-04-26 unresponsive to stimuli Sudden onset dizziness and syncope while sitting in vehicle. Event occurred within 2 minutes followi... Read more
Sudden onset dizziness and syncope while sitting in vehicle. Event occurred within 2 minutes following vaccine. Pt unresponsive for 30 seconds, pale, diaphoretic. Once awake, groggy but oriented. Unable to obtain blood pressure due to hypotension, pulse 40 and thready. After approximately 5 minutes, patient's color improved however blood pressure remained low. EMS called. Pt evaluated and was advised to seek further medical care.
56 2021-04-27 burning sensation Patient tells me 2 days prior to vaccine on 3/3 (Pfizer) she had mild hives?not unusual for her in ... Read more
Patient tells me 2 days prior to vaccine on 3/3 (Pfizer) she had mild hives?not unusual for her in the spring. They typically occur along with seasonal allergies and she thinks the hives are unrelated to current rash. She went ahead and had the 1st Pfizer vaccine on 3/3. She developed a new circular rash at the injection site on the left arm and new rash over the left side of her back described as ?on fire?. she was seen for a telemedicine clinic visit diagnosed with possible shingles and was prescribed treatment. Did not improve significantly. She went ahead and had the second Pfizer jab on 3/24. She developed extreme tenderness at injection site. the rash that was on her back got much worse and spread. The rash occurs any place she scratches, has blood drawn or gets a band-aid placement. After that second shot she also noticed that her hip joints feel ?weak and unhinged". . Has also had similar symptoms of weakness in bilateral shoulders. Feels like her leg muscles are weak (points specifically to quadriceps). She has trouble repositioning herself and doing normal activities that she had been doing without difficulty just a few weeks ago. Her RN notes that she can get out of bed and walk to bathroom but is unsteady and shuffles. Has also noticed facial and periorbital swelling with purple discoloration and darkness around eyes. Had a faint pink rash extending from eyelids up over brows that has now decreased. Feels her legs are puffy and swollen.
56 2021-04-27 migraine After 1st vaccine had an endocrine reaction -- facial swelling (moon-face) along with thrush. Also ... Read more
After 1st vaccine had an endocrine reaction -- facial swelling (moon-face) along with thrush. Also had severe headache.
56 2021-04-27 pain in extremity, tremor Severe swelling, redness and pain in right arm pit (Lymph Noles) and right arm; Seen by doctor and h... Read more
Severe swelling, redness and pain in right arm pit (Lymph Noles) and right arm; Seen by doctor and had to get a shot for inflammation, and 2 prescriptions. Around 11:30 pm on 4/27/21, had nausea, diarreah, chills/shaking uncontrollably and headache.
56 2021-04-27 pain in extremity noticed a single red blood blister on my right thumb following a hot bath 2 days after the injection... Read more
noticed a single red blood blister on my right thumb following a hot bath 2 days after the injection. the blister began to fade two days after it appeared and is now gone. Beginning this morning, 04/28/2021, I am experiencing an intermittent pain in the left lower leg, posterior medial aspect.
56 2021-04-28 weakness Dizziness, lathergy/no energy, spacy feeling, sleeping a lot.
56 2021-04-28 burning sensation raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forear... Read more
raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on RIGHT forearm; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 26Mar2021 at 10:15 at single dose for COVID-19 immunization. Medical history included allergic to penicillin, tetracycline, keflex, all sulfa drugs, Diflucan. Concomitant medication was not reported. Patient was not pregnant at time of vaccination. On 18Mar2021, patient tested nasal swab and resulted negative. Since the vaccination, the patient had been tested for COVID-19. On 26Mar2021 at 11:00, the patient experienced raised rash on left forearm & upper arm with itching & burning sensation. The patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care. Patient received treatment with steroids & Benedryl. The outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
56 2021-04-28 cold sweat, weakness 4/10 - 4/11 -- chills throughout the evening 4/11 -- fever* of 102 4/12 -- fever* of 103 -- took 1 a... Read more
4/10 - 4/11 -- chills throughout the evening 4/11 -- fever* of 102 4/12 -- fever* of 103 -- took 1 acetaminophen at 2 pm & 12 pm 4/13 -- fever* back to 103 by 6 pm, so started taking 1 acetaminphen every 6 hours until 11 pm 4/14 -- fever* of 100 at 5 pm, took last acetaminophen at 6 pm 4/15 -- no fever at 7 a.m. or 2 p.m.; very weak * Fever accompanied by chills & cold sweats. Slight cough also developed & lasted a couple weeks (possibly allergies tho' I'm on allergy meds).
56 2021-04-28 electric shock sensation, burning sensation I have had pain electric shocks from my spine. Burning all across my back lighting shocks. They last... Read more
I have had pain electric shocks from my spine. Burning all across my back lighting shocks. They last 10 seconds.
56 2021-04-28 feeling cold, tremor, seizure, muscle spasms, inability to speak shaking, muscle spasms, eyeball spasms, fatigue, tightness in thigh and arms, come and go rash on ba... Read more
shaking, muscle spasms, eyeball spasms, fatigue, tightness in thigh and arms, come and go rash on back of arm, headache, fuzzy-headed, ringing in ears that sometimes sounds like an ambulance siren, had menstrual cycle 1 week after shot and haven't had one in two years. intermittent chills, cold and sweat at same time, takes longer to find words, brain seems slower - something I've been doing for years I have to look up because I can't remember. severe shakes from waist up I think it's called convulsions but only once so far, chest tight and shallow breathing, forgetfulness
56 2021-04-28 feeling hot Client complained of throat closing minutes after getting to observation tent. Then she c/o right si... Read more
Client complained of throat closing minutes after getting to observation tent. Then she c/o right side abdominal pain, "hot and tight." Then "weird taste in my mouth." I spoke with client and she seemed not clear and a little confused.
56 2021-04-28 flushing REPORTED FEELING THROAT TIGHTNESS, SKIN FLUSHING AND LIGHTHEADEDNESS POST VACCINE, SIMILAR TO DOSE 1... Read more
REPORTED FEELING THROAT TIGHTNESS, SKIN FLUSHING AND LIGHTHEADEDNESS POST VACCINE, SIMILAR TO DOSE 1 WHICH RESOLVED SPONTANEOUSLY AFTER ABOUT 2 HOURS.. TODAY, S/S BEGAN/OCCURED WITHOUT CLINICAL FINDINGS. NO THROAT EDEMA/ERYTHEMA NOTED. VSS. ESCORTED TO EXIT WITH NO ISSUES AT 1621. 1605 LYING BP 148/76 HR 78 RR 12 SATS 99% 1615 SITTING BP 133/82 HR 71 RR 12 SATS 98% RA
56 2021-04-28 tingling The day after her 2nd COVID vaccine, patient began experiencing intermittent episodes of tingling in... Read more
The day after her 2nd COVID vaccine, patient began experiencing intermittent episodes of tingling in her bilateral hands and feet. The episodes last about 5 minutes at a time. She has no associated weakness or other concerning symptoms.
56 2021-04-29 weakness Onset of sx started several hours after first Covid vaccine. Started with severe injection site pain... Read more
Onset of sx started several hours after first Covid vaccine. Started with severe injection site pain, diffuse pruritis, body aches, fever 101.7 axillary, chills/sweats, and severe HA. Took acetaminophe, alternated w ibubrofen every 4 hours overnight. Next AM woke w T 99.7 axillary, HA, weakness, severe body aches, fatigue, sore throat and dry throat. Injection site swollen to ~7 mm diam with bruised appearance, extremely tender, unable to lie on L side. Able to sip sports drink; warm, clear liquids (soup) without appetite. Continued w Ibuprofen HA formula. Sleep difficult due to chills/sweating. Also frequent cough, SOB with ADLs. Recd Dose #2 Pfiz 4/5/21 - s/sx worsened significantly and CONTINUE.
56 2021-04-29 weakness severe body aches, joint aches, for two days, followed by vomiting , severe head pain, head spins, n... Read more
severe body aches, joint aches, for two days, followed by vomiting , severe head pain, head spins, nervousness stomach, diarrhea and despair for a few weeks. I cancelled the second shot, I don't feel strong enough to do the second shot, was not expecting severe reactions with the first shot.
56 2021-04-29 feeling cold At 5 p.m. I began having chills and as the evening progressed the chills got worse. I drank hot choc... Read more
At 5 p.m. I began having chills and as the evening progressed the chills got worse. I drank hot chocolate and that did not help. Took my shower at 7 p.m. and was cold the entire shower then went to bed with 2 blankets, a quilt, and bedsheet covering me. I had on pajama long pants and shirt along with anklet socks and still could not warm up. My hands and feet were ice cold along with my entire body. I did not feel warm until about 11 p.m. I have now noticed I have a bruise on lower left leg directly above my ankle feels like a hard spot on my vein area.
56 2021-04-29 pain in extremity Arm soreness to touch and with movement x 3 days, gradually lessening each day. Significant fatigue ... Read more
Arm soreness to touch and with movement x 3 days, gradually lessening each day. Significant fatigue on day 3 post injection x 1 day.
56 2021-04-29 tingling Facial redness and tingling (specifically above eyebrows and lips). Returned to vaccination clinic ... Read more
Facial redness and tingling (specifically above eyebrows and lips). Returned to vaccination clinic around 5pm reporting symptoms
56 2021-04-29 tingling Patient complained of tingling on left side of his neck, arm, and leg. Onsite EMS was called vitals ... Read more
Patient complained of tingling on left side of his neck, arm, and leg. Onsite EMS was called vitals BP 128/44 HR 68 98% O2 BG 121. No throat swelling or rash, lungs clear. She was encorgaged to follow up with your MD. Relesed to go home.
56 2021-04-30 feeling of body temperature change, pain in extremity Diarrhea; Congestion nasal; sniffles, runny nose aching; sniffles, runny nose aching; Coughing; Left... Read more
Diarrhea; Congestion nasal; sniffles, runny nose aching; sniffles, runny nose aching; Coughing; Left arm sore; Hot and cold; Throat sore; Hard time swallowing and feels like she has to force to swallow; "COVID - like symptoms" /side effects she was having almost feels like she has COVID; Fatigue/exhausted/no energy; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8731) injected intramuscularly in left arm on 12Apr2021 12:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. No prior vaccinations within 4 weeks. The patient just got the first vaccine on 12Apr2021. On 13Apr2021, the patient experienced fatigue/ felt exhausted/ no energy. On 13Apr2021 01:00, she was having coughing/ hadn't stopped coughing, sore left arm, hot and cold, throat was very sore, congestion nasal, sniffles, runny nose aching. She was nervous about getting second dose. She was thinking about calling yesterday, but she did not have the energy. She was having a hard time swallowing and felt like she was having to force herself to swallow. The diarrhea was just twice, on 13Apr2021 14:00 and 17:00. She was concerned about feeling like her throat was closing. She just kept drinking water. She was not swollen though. Patient reported that the symptoms were "COVID - like symptoms", the side effects she was having almost feels like she has COVID. No ER or physician's office required. No relevant tests. The outcome of diarrhea was recovering, outcome of fatigue was unknown, outcome of other events was not recovered. No follow-up attempts are possible; No further information expected.
56 2021-04-30 muscle twitching, tremor, muscle spasms neck ache; headache with intermittent nausea; headache with intermittent nausea; muscle spasms and m... Read more
neck ache; headache with intermittent nausea; headache with intermittent nausea; muscle spasms and muscle twitches that did not start until after she got home a few hours later.; muscle spasms and muscle twitches that did not start until after she got home a few hours later.; the muscle twitches have become worse and are "more intense" and "more often."; her eyeballs feel like "they're shaking in my head"; she has fatigue in her quads; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter states she received the first dose of vaccine on 05Apr2021 and reports afterwards approximately on an unknown date in Apr2021, the patient experiencing neck ache and headache with intermittent nausea and muscle spasms and muscle twitches that did not start until after she got home a few hours later. She reported that the muscle twitches had become worse and were more intense and more often. Her eyeballs felt like they were shaking in head and had fatigue in her quads. She wanted to know what to do to make these side effects go away. She was curious if Pfizer has any products that could be used to treat her symptoms and what were the reported side effects there are with the Pfizer BioNTech COVID-19 vaccine. She asked if you were in a situation where you were worried about side effects, what questions would you ask. She reported that she was scheduled to receive her second dose of the Pfizer BioNTech COVID-19 vaccine on 26APR2021 but does not know if she should get it or wait on it due to her lingering side effects. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
56 2021-04-30 pain in extremity, weakness shivering cannot control; chills; tiredness; weakness; joint pain; everything was sore; pain in her ... Read more
shivering cannot control; chills; tiredness; weakness; joint pain; everything was sore; pain in her right arm/arm really hurt; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in right arm on 05Apr2021 (Lot Number: PFER8737) (at age 56 years old) as single dose for covid-19 immunisation. Medical history included migraine because once in a while she can't get rid of it. She confirms she had this event prior to the COVID vaccine. There were no concomitant medications. The patient previously received flu shot on an unspecified date for immunization. The patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 05Apr2021 and 6 days after the 1st dose she experienced pain in her right arm, shivering cannot control and lasted for 45 mins, joint pain, headache, tiredness, weakness. She took paracetamol (TYLENOL) but it did not resolve the pain. She took ibuprofen instead. She was asking if it is normal to have these side effects 6 days after getting the vaccine and how long it usually last. Her second dose will be given on 09Apr21 and she was asking if she can still get the 2nd shot due to the symptoms. She stated she had some pretty rough side effects from it including chills. She was calling to find out if she is going to be okay. She stated she has all the symptoms listed except for nausea, fever, and the lymph node problem. She received the shot on 05Apr2021, and her arm really hurt for 3 days. Then, on Sunday (11Apr2021), 6 days later, she woke up at about 4 am with chills. She was shivering like crazy. She was under lots of blankets. She couldn't control shivering at all and this lasted for about 45 minutes. She mentioned her side effects were not good. She is almost scared to take the second dose. When describing her joints, she explained it felt like somebody ran over her- her joints in her body, her feet, everything was sore. It's like the way one feels if they have a flu. Her joints are killing her. She hurts. She is tired. She has been swallowing ibuprofen and another product, PAIN-EZE, they were offering at work that has 3 different ingredients in it including aspirin, but she still couldn't get rid of the pain. She was unable to provide the spelling of the medication name, but pronounced it as "PAIN-EZE". She mentioned she doesn't take paracetamol because paracetamol doesn't do anything for her. She clarified the ibuprofen kicked in for a while, but did not last. Her mom is a registered nurse (RN) and she called her, and her mom told her some people get over symptoms sooner, everybody's different. She wanted to know why her symptoms began 5-6 days after the vaccine. She was in the ER and she had a headache real bad and she was given a migraine cocktail that included diphenhydramine (BENADRYL), tramadol, and something else so that she wouldn't throw up. She clarifies she went to the ER for that particular migraine because once in a while she can't get rid of it. She confirms she had this event prior to the COVID vaccine. She mentions she worked as a nursing assistant and medical aide and had flu shot after flu shot and never had anything happen like this. She has never had any reaction to any vaccine. She wasn't sick when she went into get the shot. All these symptoms came after the shot. No relevant tests done. She was trying to get through this and go back to work. She was hoping these side effects will end soon. She still has the chills, everything aches. When she takes Ibuprofen, it will take the pain away for a little awhile, but it doesn't completely take it away, it just numbs it out. She had just been trying to get through it. The events did not require emergency room visit nor a physician office visit. The patient had not recovered from pain in her right arm, joint pain, and everything was sore, recovered from shivering on 11Apr2021, while unknown for the rest of the events.
56 2021-04-30 pain in extremity, tingling, speech disorder I felt tingling in the feet hands and mouth; After a lot of sleep; second day strong pains began in ... Read more
I felt tingling in the feet hands and mouth; After a lot of sleep; second day strong pains began in the back; Inflammation in the ganglia; shortness of breath; High or slow heart rate; I began to feel strong pain in my spine, legs and joints; I feel uncoordinated to speak; I began to feel strong pain in my spine, legs and joints; It is a horrible feeling.; This is a spontaneous report from a contactable consumer (patient herself). A 56-years-old non-pregnant female patient started therapy with bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162), via an unknown route on 16Apr2021 at 1:00 pm in the arm left as a single dose for COVID-19 immunization. The patient's medical history included hypertension and a liver problem. Patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient 2 weeks prior to the COVID vaccine included Bisoprolol (5mg). Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient did not have allergies to medications, food or other products. On 17Apr2021 at 14:30, the patient felt tingling in her feet, hands and mouth and became very sleepy. On the second day after vaccination, patient felt strong pain in her spine, legs and joints and neck. The patient also reported neck lymph nodes inflammation and shortness of breath. Patient reported that high or low heart rate and she felt uncoordinated to speak. Patient described that it as a horrible feeling. The outcome of the events was not resolved. It was unknown if the patient taken any treatment due to AE. No follow-up attempts are needed. No further information is expected.
56 2021-04-30 pain in extremity Sore arm, and extreme headache with dry heaves.
56 2021-04-30 pain in extremity This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 at 13:15 (Lot/batch number: ER8733, Expiration date: 31Jul2021) on the left arm as single dose for COVID-19 immunization. Medical history included osteoarthritis. Concomitant medications included ongoing methotrexate sodium, ongoing sulfasalazine and unspecified drug. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 at 15:00 as single dose for COVID-19 immunization. No additional vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks), no events following prior vaccinations. Patient received the second dose of the Pfizer COVID-19 vaccine on 31Mar2021. She received a phone call yesterday (13Apr2021) from the vaccination site that an error was made and a small group of patients possibly received saline instead of the vaccine. Patient stated she was "99.99% sure I got the vaccine" because she had the following side effects: headache that night and couldn't sleep. The next day she had body aches, a little fever of 100, and a sore arm. The vaccination site was recommending per the CDC to revaccinate everyone who potentially received saline any time after 21Apr2021. Patient was currently scheduled to receive a revaccination with a third dose on 23Apr2021. She wanted to know if she should take a third dose, she knew there were studies about taking a third dose as a booster. Patient was thinking about canceling the revaccination as there wasn't enough information on the study regarding a third vaccine. Patient thought she did receive the COVID-19 vaccine because she had a headache and sore arm on 31Mar2021. The night she received the COVID-19 vaccine she was restless and could not sleep. She had body aches and a fever and was really achy the next day. She's thinking she received the COVID-19 vaccine and not just saline. She explained her situation to a nurse and a pharmacist, and she was told that saline could cause a fever. She's been advised to receive a third COVID-19 vaccine 21 days after the date of the second COVID-19 vaccine. Patient reported due to the COVID-19 virus she had gained weight. On 31Mar2021 she could not sleep at all. It was like she was on steroids. She got up at 3:00AM to read. She had a little injection site pain the day of the vaccine but that was gone the next day. She had a fever of 100 degrees Fahrenheit on 01Apr2021. Then half an hour later her temperature would be normal, then a couple hours later she'd have a fever again. She knew she had a fever because she felt hot. On Saturday, 03Apr2021 she woke up and did her normal Saturday things. She felt better and her symptoms had resolved. Lab data included patient temperature was 100 degrees Fahrenheit on 01Apr2021. No events required a visit to emergency room or physician office. The outcome of the event possibly received saline instead of the vaccine was unknown, the events sore arm and injection site pain was recovered on 01Apr2021, while of the other events was recovered on 03Apr2021. No follow-up attempts are needed. No further information is expected.
56 2021-04-30 seizure seizures; soreness; extreme fatigue; injured; illness; This is a spontaneous report from a contactab... Read more
seizures; soreness; extreme fatigue; injured; illness; This is a spontaneous report from a contactable consumer, the patient. This 56-year-old non-pregnant female patient the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 08Apr2021 13:30 (at the age of 56-year-old) as single dose for COVID-19 immunization. Medical history included seizure (not medicated), asthma, allergies, deprived of nightly decent sleep (from 24/7 low frequency torture by neighbor's ventilation system), and allergies: DILANTIN (phenytoin sodium), "1 other seizure drug" and sulfonamide drugs. The patient was receiving unspecified concomitant medication(s). The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18Mar2021 13:30 (at the age of 56-year-old) as single dose for COVID-19 immunization. On 11Apr2021 00:30, the patient experienced seizure. On an unspecified date in Apr2021, she also experienced the soreness, extreme fatigue, injured and illness. The clinical course was described as follows: "I suffer from occasional seizures for which I am not medicated and I had one after midnight 2 days after the vaccination. Other symptoms were just soreness and extreme fatigue. I suspect this seizure is due to my lack of oxygen from my laying in bed the next day in this case but wanted to report it in case it matters. I normally suffer seizures very rarely and always in bed at 3 or 4 a.m. at times when I am sick or lacking sleep. This time I had my seizure in the bathroom and I am afraid I have no further information except that I likely only had one since I was missing from the bedroom for less than an hour as near as we can tell. I woke up on the floor injured and unaware of my surroundings. I have never had a seizure while awake before unless it was a second one. I have been deprived of nightly decent sleep by several neighbors for over 3 years now by a low frequency noise from a pot grow ventilation system that has caused me illness and was bad near the time of vaccination." No treatment was received for the adverse events. The clinical outcome of the seizure, soreness, extreme fatigue, injured and illness was resolving. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
56 2021-05-01 numbness, tingling Immediately with the administration of the vaccine I had a shooting tingling/numbness/pain that went... Read more
Immediately with the administration of the vaccine I had a shooting tingling/numbness/pain that went from the injection site down my arm to my fingers. The sensation worsened and became more painful accompanied by a weakness in my right arm. I went my primary care physician to have this looked at. My injection was nearly 3.5 months ago and I still continue to experience the same symptoms. I have ongoing pain/weakness down my entire right arm.
56 2021-05-02 weakness Patient complained of pain at injection site in left deltoid x 2 days following second COVID-19 vac... Read more
Patient complained of pain at injection site in left deltoid x 2 days following second COVID-19 vaccine administration at that site 2 days ago. Pt reports associated pruritis at the injection site w/ redness, swelling, TTP, and the area feeling firm. Pt reports the symptoms began several hours after the injection and the affected area has been changed appreciably since onset. Pt reports no meds/creams utilized for these symptoms. Pt reports chills, malaise, and decreased energy level yesterday that since resolved. Pt reports no systemic symptoms today.
56 2021-05-02 pain in extremity, numbness Following day, minor soreness & numbness of upper left arm Day 3, continued numbness of arm & also s... Read more
Following day, minor soreness & numbness of upper left arm Day 3, continued numbness of arm & also shoulder area As of May 3rd, numbness still present along with some tightness on left side of neck
56 2021-05-02 pain in extremity April 9, excrutiating pain in Left foot. April 10, excrutiating pain in right foot. April 11, pain... Read more
April 9, excrutiating pain in Left foot. April 10, excrutiating pain in right foot. April 11, pain in both feet. Can hardly walk, all of a sudden out of nowhere! Went to Urgent care April 12th. Unknown. Podiatrist April 14th, Unknown. Another Podiatrist April 21st, Unknown, but orders X-Rays. Show nothing. Walking like a crippled person in pain. Again, all of a sudden out of nowhere!. Sunday, April 25, excrutiating pain, weight-bearing on right foot. Husband carries me to the car and drives to ER . NOTE: All physical exams did not cause pain when manipulating joints.
56 2021-05-03 numbness Patient is a 56 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 3... Read more
Patient is a 56 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot EW0161 on 5/4/2021. 1008:The patient experienced the following reaction(s) during the immediate of observation: pt reports feeling nauseous, generalized itchiness and numbness in arm and lips. Pt denies trouble breathing or difficulty swallowing. 1024:Patient was treated/managed as follows: Pt brought to treatment area and given water, and kidney basin for symptoms of nausea. VS performed: BP- 130/86, HR-77, R-18, 02-98% RA. Pt symptoms have lessened at this time. Pt refuses to take benadryl on site and is advised to take benadryl once home. Pt escorted out of lobby safely by RN. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.
56 2021-05-03 pain in extremity, limb paralysis Pain in arm next day - dead arm for two days - sore for 5 more days - looked in mirror and saw red b... Read more
Pain in arm next day - dead arm for two days - sore for 5 more days - looked in mirror and saw red ball size blotch, hot to touch. Would wake me up once at night.
56 2021-05-03 pain in extremity Tinnitus; severe headache; Fever; arm pain; Fatigue; This is a spontaneous report from a contactable... Read more
Tinnitus; severe headache; Fever; arm pain; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration, administered in left arm on 10Apr2021 09:00 AM (at 56-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included known allergies: Sulfa drugs. No prior history of tinnitus or auditory disorder. No covid prior vaccination. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration, administered in left arm on 19Mar2021 09:00 AM (at 56-year-old) at single dose for COVID-19 immunisation. No other vaccine in four weeks. No other medications in two weeks. On 10Apr2021 07:00 PM, the onset of symptoms began 10 hours after the second dose injection, including severe headache, fever, arm pain, fatigue, and tinnitus. All symptoms persisted intensely for 24 hours, then started to lift with the exception of headache and tinnitus. The headache resolved at about 48 hours. Tinnitus remains severe and consistent since the day of the shot. The events resulted in disability or permanent damage. No treatment was received for the events. The outcome of the events was not recovered. No Covid tested post vaccination.
56 2021-05-03 pain in extremity PATIENT REPORTED TO HAVE VAGINAL BLEEDING LIKE A PERIOD FOR COUPLE DAYS AFTER HER 1ST SHOT. SHE CONT... Read more
PATIENT REPORTED TO HAVE VAGINAL BLEEDING LIKE A PERIOD FOR COUPLE DAYS AFTER HER 1ST SHOT. SHE CONTACTED HER DOCTOR BUT WAS ADVISED TO GET THE 2ND DOSE AS WELL CAUSE THE DOCTOR WASNT SURE THE BLEEDING IS FROM THE VACCINE. HOWEVER, THE PATIENT REPORTED TO HAVE VAGINAL BLEEDING AGAIN AFTER HER 2ND DOSE FOR 1 DAY. SHE ALSO REPORTED TO HAVE SORE ARM, AND BODYACHE AFTER THE 2ND DOSE.
56 2021-05-03 pain in extremity Pain in left arm was followed a few hours later by chills, body aches, diarrhea, nausea, severe hea... Read more
Pain in left arm was followed a few hours later by chills, body aches, diarrhea, nausea, severe headaches, mild fever, and some fatigue. Then about 36 hours after vaccination I had radiating back pain in my mid-upper back and severe indigestion (I have never had indigestion before) and a somewhat heavy feeling in chest when breathing . Approximately 48 hours after the vaccination almost all symptoms subsided, just a sore arm remains.
56 2021-05-03 pain in extremity Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Arm Pain
56 2021-05-04 inability to speak As I was walking down the street I became short of breath and my chest became extremely tight. It fe... Read more
As I was walking down the street I became short of breath and my chest became extremely tight. It felt like I was having a severe asthma attack because I was unable to breath. My chest felt like something was squeezing it. I barely made it back to my house. I had to sit on my front steps. I managed to use my cell phone to call my husband, but I could only say on word answers ex. "drink" then "door". It took awhile after having a cold drink that I was able to tell my husband what happened. Later after resting I began to get really sharp pains in my chest on the right side.
56 2021-05-04 weakness After 2nd shot, I got headaches and had super low energy, fatigue the day after the shot.
56 2021-05-04 bell's palsy, numbness Bell's Palsy; Headache; jaw ache; ear ache; numbness in face; Assuming ear infection; This is a spon... Read more
Bell's Palsy; Headache; jaw ache; ear ache; numbness in face; Assuming ear infection; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 27Mar2021 12:45 (Lot Number: EP6955) as single dose (at 56 years old) for COVID-19 immunisation. Medical history included none. Concomitant medications included atorvastatin, cetirizine hydrochloride (ZIRTEC), Forces of Nature Skin Tag. On 13Apr2021, the patient experienced Bell's Palsy (medically significant), headache, jaw ache, ear ache, numbness in face, assuming ear infection. Therapeutic measures were taken as a result of the events included Prednisone. The outcome of the events was recovering. The patient required a visit to the emergency room and diagnosed with Bell's Palsy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination.
56 2021-05-04 breast pain terribly sick; terrible headache; aches started/ Everything was hurting; her left arm where she got ... Read more
terribly sick; terrible headache; aches started/ Everything was hurting; her left arm where she got the vaccine, under her arm, her lymph nodes swelled to the size of a little kid's ball; Part of her left breast near the swollen lymph node was sore; back was hurting; couldn't even sleep with her ankles together in bed because she was hurting; couldn't even sleep with her ankles together in bed because she was hurting; low grade fever/ feeling feverish; congestion; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 56-years, at single dose in left arm on 05Apr2021 11:30 (Lot Number: ER8735) for covid-19 immunisation. The patient medical history was not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) also at age of 56-years, at single dose in left arm on 15Mar2021 13:45 (Lot Number: EP7534) for covid-19 immunisation. The patient had no side effects from the first covid-19 vaccine. Concomitant medications included ongoing estradiol and atenolol; montelukast sodium (SINGULAIR); ongoing rosuvastatin calcium. The patient reported that her side effects were terrible. She felt fine after her vaccine but that night on 05Apr2021, she became terribly sick. She had a terrible headache. Then aches started. In her left arm where she got the vaccine, under her arm, her lymph nodes swelled to the size of a little kid's ball, liked a toddler sized ball. She was sure it was the lymph node. Part of her left breast near the swollen lymph node was sore. It was just really terrible. Her back was hurting. Everything was hurting. She couldn't even sleep with her ankles together in bed because she was hurting. She was totally miserable. She also had a low-grade fever. She thought she would feel better the next day but her symptoms went on the whole week. As far as she could tell her symptoms were over on 10Apr2021. By 10Apr2021, she didn't feel bad anymore and the lymph nodes under her arm had gone down. And she had been taking Tylenol (took 2 tablets almost every time) and different things for her headache and feeling feverish. She had to take something for her aches. She had no idea her symptoms were going to continue that long. She also took Mucinex because she had congestion and she wanted to try and dry herself up. She had called her primary care doctor and was told to go to the emergency room but she never went. She was already miserable enough, she didn't want to sit in the emergency room. The patient did not take vaccines and probably hadn't had a vaccine since she was a teenager and that was a long time ago. She has no known allergies to medications. It was reported that the adverse events did not result in a visit to Emergency room or Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome for event congestion was recovering, while for remains event was recovered on 10Apr2021. No follow-up attempts are needed. No further information is expected.
56 2021-05-04 muscle spasms, nerve injury, pain in extremity sustain cramps in her right leg; limited range of motion; not sure if there was a nerve that has bee... Read more
sustain cramps in her right leg; limited range of motion; not sure if there was a nerve that has been damaged or early stage of thrombosis; not sure if there was a nerve that has been damaged or early stage of thrombosis; severe arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 12Apr2021 at 09:30 (at the age of 56 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication was none. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 18Apr2021 at 18:00, the patient experienced severe arm pain that was described as arm pain was too painful and have been woken up out of her sleep and she has limited range of motion and she was not sure if there was a nerve that has been damaged or early stage of thrombosis. On 20Apr2021, the patient experienced sustain cramps in her right leg. The patient did not receive treatment for the events. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
56 2021-05-04 muscle twitching, pain in extremity Tinnitus - extreme onset of ear ringing to previously perfect hearing. Started in the left ear, acco... Read more
Tinnitus - extreme onset of ear ringing to previously perfect hearing. Started in the left ear, accompanied by extreme neck and shoulder tightness. Ringing is also in right ear now. Tension has subsided but the ringing very unfortunately remains... Arm tightness, in left arm, also caused ulna nerve in elbow to become trapped and twitch, one day after injection. Arm soreness for a day after shot.
56 2021-05-04 pain in extremity Car accident; she felt fatigued; She had a cough for a few hours; arm soreness/could feel in her lef... Read more
Car accident; she felt fatigued; She had a cough for a few hours; arm soreness/could feel in her left arm where she got the shot; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 16Mar2021 around 15:20 (Lot Number: EN6204) as single dose for covid-19 immunisation. Medical history included ongoing chronic fatigue immune dysfunction, She was diagnosed in her 30s. She is on no medications for the currently, ongoing herpes. Concomitant medication included valaciclovir 1 tab, 1000mg, oral 2 times a day as needed taken for herpes. The patient experienced arm soreness, could feel in her left arm where she got the shot on 2021, she felt fatigued on 16Mar2021, she had a cough for a few hours on 2021, car accident on 27Mar2021. The patient underwent lab tests and procedures which included X-rays of her neck on 05Apr2021 with unknown result. The outcome of Pain in arm was recovered, fatigue was recovering, the other was unknown. No follow-up attempts are needed. No further information is expected.
56 2021-05-04 pain in extremity achy/She had body aches; general malaise; The general achiness has been happening on and off consist... Read more
achy/She had body aches; general malaise; The general achiness has been happening on and off consistently since she was rear-ended. It is in her neck and her back; The general achiness has been happening on and off consistently since she was rear-ended. It is in her neck and her back; Coughing; Left arm soreness; Little cold; muscle achiness; She had gained some Covid weight; abdominal discomfort like pain; ribs feel almost bruised; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 56-years, at single dose in left arm on 06Apr2021 (Lot number: EN8732 or ER8732 (unsure)) for covid-19 immunisation. Medical history included ongoing Chronic fatigue immune dysfunction. She was diagnosed in her 30s. She was on no medications for the currently. And ongoing herpes. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 56-years, at single dose in left arm on 16Mar2021 (Lot number: EN6204) for covid-19 immunisation and she experienced fatigued and Cough. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Concomitant medication included valaciclovir taken for herpes outbreak. The patient experienced ribs feel almost bruised (musculoskeletal chest pain) on 12Apr2021, headache 18 hours after the shot (in Apr2021), achy/she had body aches (pain) on an unspecified date, general malaise on an unspecified date, general achiness has been happening on and off consistently since she was rear-ended and it was in her neck and her back (back pain and neck pain) on an unspecified date, abdominal discomfort like pain on 15Apr2021, coughing on an unspecified date, left arm soreness on an unspecified date, little cold on an unspecified date, muscle achiness on unspecified date; She had gained some Covid weight on an unspecified date. The patient underwent lab tests and procedures which included X-rays of her neck after a car accident with unknown result on an unknown date. She took Tylenol and Excedrin Migraine pill for headache. It was reported that the adverse events did not result in a visit to Emergency room or Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events outcome was unknown. No follow-up attempts are needed. No further information is expected.
56 2021-05-04 tingling 3 days post, pt notified clinic of nausea, muscle aches, burning sensation in her arm, and dizziness... Read more
3 days post, pt notified clinic of nausea, muscle aches, burning sensation in her arm, and dizziness. Symptoms improved Received 2nd dose on 4/14-now with dizziness, unsteady gait, tingling in all extremities
56 2021-05-06 numbness Severe abdominal pain upper left side Shortness of breath Chest pain Severe fatigue Numbness in ... Read more
Severe abdominal pain upper left side Shortness of breath Chest pain Severe fatigue Numbness in arms at night
56 2021-05-06 tremor Blood clot in nose, fatigue, shaking, tachycardia, mood change
56 2021-05-07 weakness chest tightness, difficulty breathing, feeling of something stuck in her throat , weak, patient was... Read more
chest tightness, difficulty breathing, feeling of something stuck in her throat , weak, patient was given EpiPen 0.3 mg 1 dose and we called 911
56 2021-05-07 burning sensation Bone pain; Muscle pain into the soles of her feet; burning sensation in arm which radiated into fing... Read more
Bone pain; Muscle pain into the soles of her feet; burning sensation in arm which radiated into finger tips and joints; burning sensation in arm which radiated into finger tips and joints; headache; inability to concentrate; a quickly rising fever reaching 102.5, for 18 hours; Nausea; teeth sensitivity, all the nerves in patient's teeth hurt; teeth sensitivity, all the nerves in patient's teeth hurt; Swelling under arm of second dose injection site; Swelling under arm of second dose injection site, painful to put at side; It felt like there was a scorching hot balloon in there and other heat radiates into patient's chest; Feeling of heaviness in head still three days later; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided), via an unspecified route of administration, in right arm, on 03Feb2021 (at the age of 56-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history was not reported. Patient had no known allergies. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medications included colecalciferol (VITAMIN D), estradiol (VIVELLE) patch .05 estrogen only, and famotidine (PEPCID). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiration date not provided), via an unspecified route of administration, in left arm, on 14Jan2021 20:30 (at the age of 56-year-old), at single dose, for COVID-19 immunization, and had headache, tired and arm soreness. On 04Feb2021 12:00, 16 hours post injection, patient had sudden onset of severe bone pain, muscle pain into the soles of her feet, burning sensation in arm which radiated into finger tips and joints, headache, inability to concentrate, a quickly rising fever reaching 102.5, for 18 hours, the above symptoms had left. Patient also had following persist events included nausea for 3 days day, teeth sensitivity, all the nerves in patient's teeth hurt, for 3 days; swelling under arm of second dose injection site, painful to put at side for three days; It felt like there was a scorching hot balloon in there and other heat radiates into patient's chest. Patient had feeling of heaviness in head still three days later. Lab test included COVID test (Nasal Swab, PCR) on 03Feb2021 was negative. No treatment received for events. The outcome of events "bone pain/muscle pain into the soles of her feet/burning sensation in arm which radiated into finger tips and joints, headache, inability to concentrate, a quickly rising fever" was recovered; of other events was not recovered.
56 2021-05-07 flushing The clinic wanted me to stay at the clinic for 30 minutes after the shot. I started to feel itching ... Read more
The clinic wanted me to stay at the clinic for 30 minutes after the shot. I started to feel itching approximately 20 minutes after the shot. My face then became flushed & heart felt like it was racing. The staff brought me to another area and checked my blood pressure as well as dispatched team for assistance. They gave me benedryl since I opted not to use my epi pen. I stayed until they had 3 readings of my blood pressure reducing. Continued to take benedryl for 2 days after the appointment.
56 2021-05-07 pain in extremity Felt very stuffy and my chest felt tight.; Felt very stuffy and my chest felt tight.; Extremely sore... Read more
Felt very stuffy and my chest felt tight.; Felt very stuffy and my chest felt tight.; Extremely sore; This is a spontaneous report from two contactable consumer or other non hcp. A 56-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration administered in arm left on 06Mar2021 13:30 as single dose for covid-19 immunization. Medical history included allergy to penicillin and keflex. Concomitant medications included benzylpenicillin sodium, procaine benzylpenicillin (PANCILLIN [BENZYLPENICILLIN SODIUM;PROCAINE BENZYLPENICILLIN]) taken as an antidepressant therapy. cefalexin monohydrate (KEFLEX [CEFALEXIN MONOHYDRATE]) taken for anxiety. Patient took her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) in arm left on 07Apr2021 13:30 for covid-19 immunization, The patient experienced felt very stuffy and her chest felt tight also experienced extremely sore on 17Mar2021. It was asked to patient to confirm event onset date as if case late delay comment required. Outcome of the events was recovered on an unknown date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-05-09 weakness weakness, runny nose, diarrhea, inflammation, chest pains, anxiety, swollen face, fingers, brain fog... Read more
weakness, runny nose, diarrhea, inflammation, chest pains, anxiety, swollen face, fingers, brain fog,
56 2021-05-09 pain in extremity Unusual adverse effect of multiple bruises forming afterward on upper left arm, not at the vaccinati... Read more
Unusual adverse effect of multiple bruises forming afterward on upper left arm, not at the vaccination site but circling the arm. Otherwise, symptoms were severe but as predicted: sore arm within 5 hours of vaccination, chills within 8 hours, fever (reached 103F at about 11 hours after), extreme flu-like symptoms (fatigue, alternating chills and fever). I'm concerned only about the bruising.
56 2021-05-09 pain in extremity Woke up in the morning with petechial hemorrhages (pinpoint dots) from elbow down to fingertips only... Read more
Woke up in the morning with petechial hemorrhages (pinpoint dots) from elbow down to fingertips only on right arm, which is the side of vaccination. Dull ache down arm is present. Joints are swollen more on right side.
56 2021-05-09 tremor Tachycardia shakes chills loose stools fatigue.
56 2021-05-10 weakness Headache this morning; Blisters on right shoulder blade; Right hip, left hip, lower back, right shou... Read more
Headache this morning; Blisters on right shoulder blade; Right hip, left hip, lower back, right shoulder inflamed; Right hip, left hip, lower back, right shoulder inflamed; Artificial hip felt like it was heating up; Fever; Severe body aches; feeling weak; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EW0164 and expiration date not reported), via an unspecified route of administration in arm right on 15Apr2021 (at the age 56-year-old), as a single dose for COVID-19 immunization. Medical history included arthritis diagnosed about 20 years ago, hip replacement from Feb2015 to unspecified date and allergy to flowers in bloom, tree pollen, cut grass, dogs, cats, horsehair, dander, Penicillin's, Keflex, Tetracycline, Erythromycin, Aspirin and Morphine. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: ER2613 and expiration date not reported), via an unspecified route of administration in arm right on 23Mar2021 as a single dose for COVID-19 immunization (no problems with the first dose of the vaccine; she didn't even have a sore arm). She has been sick all weekend. States today her temperature is 99.5 degrees. Says her fever began on Friday 16Apr2021. She takes her temperature because her job doing construction in hospitals has them take their temperatures every day. Says that her temperature kept climbing on Friday, it reached 103.7 degrees Friday night and persisted Saturday until Saturday night. States it continues to go back up and the lowest it has gone down to is 99 degrees. Has not gone back up as high as 103.7 degrees. The patient States blisters were on her right shoulder blade on 17Apr2021, severe body aches: Right hip, left hip, lower back, right shoulder inflamed began on Friday 16Apr2021. Sunday evening, she laid down and took a nap and then symptom was gone. The patient is just feeling weak and drained from it. Artificial hip felt like it was heating up began on 16Apr2021, caller says that once her fever went down, she couldn't feel this anymore. Says when her fever was at its highest on Friday and Saturday her hip felt really hot. States it felt like the titanium was heating up. The area felt hot and inflamed. Resolved when fever decreased Saturday night. States that her weirdest symptom, that she thinks was from the fever; was her artificial hip felt like it was heating up, like it felt hot inside her leg. Also states she has a headache this morning on 19Apr2021. She has been alternating Tylenol and Aleve for her symptoms. Outcome of Severe body aches and Right hip, left hip, lower back, right shoulder inflamed was recovered with Sequel on 18Apr2021, Blisters on right shoulder blade was recovered on 19Apr2021, Artificial hip felt like it was heating up was recovered on 17Apr2021 and fever was resolving, Headache this morning and feeling weak was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
56 2021-05-10 weakness reported having only pain in back and pain in joints; reported having only pain in back and pain in ... Read more
reported having only pain in back and pain in joints; reported having only pain in back and pain in joints; fever; vomiting; no appetite; can't eat; strong cough or expectoration; started to feel bad also; she was too weak; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine. Patient asked if it would be okay to get the second dose, will it be worse on the 2nd dose, I had a side effect after the first dose of the vaccine. Should I get the second dose. Patient mentioned that she was okay after 7 days, reported having only pain in back and pain in joints. Patient mentioned her husband was not feeling well initially, and afterwards, patient started to feel bad also. After 10-11 days after the vaccine, patient reported to have a fever, vomiting, no appetite; can't eat, and a strong cough or expectoration. patient asked if these were possible side effects of this vaccine, offered to transfer to safety, but patient declined, mentioned she was too weak to do that right now. The outcome of the events was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained.
56 2021-05-10 burning sensation, tremor, electric shock sensation Within approximately 5 minutes of receiving the vaccine my neck felt odd and then I immediately felt... Read more
Within approximately 5 minutes of receiving the vaccine my neck felt odd and then I immediately felt a cerebral sensation, a "zip" across my brain and then immediately following my heart started racing and I began to feel nauseous and lightheaded. I wasn't sure if I was going to vomit or pass out. I began diaphragmatic breathing to help calm my system. My heart and pulse were racing. I began to feel shaky/trembling. I finally stood up to get some help but no employees were visible so I return and sat back down. I kept breathing and assessing myself (I have a medical background). Finally after approximately 10 minutes the immediate strong adverse reaction calmed enough for me to walk out of the store [luckily my husband was with me]. We returned home. I remained feeling shaky, tired and lightheaded for days. 5 days after my vaccine I started having headaches and left lower quadrant pain [near ovaries] and a burning sensation throughout my body. I felt feverish but did not have a fever. I have lot balance several times as well and continue to feel lightheaded and tired.
56 2021-05-10 numbness, pain in extremity "ache" in the middle finger of her hand; she "doesn't feel much" as if her arm is numb; she cannot d... Read more
"ache" in the middle finger of her hand; she "doesn't feel much" as if her arm is numb; she cannot do much with that arm, her hand is also "stiff"; hurting ang burning when she moves her arm; swollen gland/lymph between her shoulder and neck, near the bone; she feels the "pressure" in that arm; "ache and a bruise" where the vaccine was injected; "ache and a bruise" where the vaccine was injected; This is a spontaneous report from a contactable consumer (reported herself). A 56-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) administered in left arm via an unknown route of administration, on 20Apr2021 as SINGLE DOSE for covid-19 immunization. Historical vaccine included first dose of BNT162B2. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated after receiving second dose on left arm patient had "ache and a bruise" where the vaccine was injected, "but it was gone the next day". On 21Apr2021, patient had experienced "swollen gland/lymph between her shoulder and neck, near the bone" on the same side she received the injection, plus it is "hurting ang burning" when she moves her arm. She specified her left arm "is hurting" all the way to her "shoulder" and the pain extends to "the back of that shoulder". She said she feels the "pressure" in that arm but when she "pinches it", she "doesn't feel much" as if her arm "is numb". She mentioned she cannot do much with that arm, her hand is also "stiff", and she has difficulty using it. She added yesterday, she started to have "ache" in the middle finger of her hand. She asked if her symptoms were reported as side effects to the vaccine. The outcome of the events were unknown. No follow-up attempts were needed; Information about lot/batch number cannot be obtained.
56 2021-05-10 numbness Numbness of left cheek, lips and entire chin; This is a spontaneous report from a contactable Nurse ... Read more
Numbness of left cheek, lips and entire chin; This is a spontaneous report from a contactable Nurse or other healthcare professional. A 56-years-old non-pregnant female received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 26Jan2021 at 09:30 in the left arm as a single dose for COVID-19 immunization. The past medical history included Diabetes, high cholesterol and eczema. The concomitant medications which were received within 2 weeks of vaccination included Insulin, Crestor, Dupixent, Truliciyy and Tylenol. The patient was allergic to Augmentin, latex and Levaquin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On 27Jan2021 at 12:00, the patient experienced numbness of left cheek, lips and entire chin. The patient did not receive any treatment for the adverse event. The outcome for the event was not recovered. Information on the lot/batch number has been requested. Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
56 2021-05-10 numbness anaphylaxis; headache with numbness; headache with numbness; blurred vision and nausea from headache... Read more
anaphylaxis; headache with numbness; headache with numbness; blurred vision and nausea from headache; blurred vision and nausea from headache; has been trapping food since in her throat; had irritation in her throat; coughing; coughing; off balance; couldn't see straight; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Left Arm on 18Mar2021 10:30 (at age of 56 years old) as single dose for COVID-19 immunisation. Relevant medical history included: Asthma, immune problems, upper respiratory stuff, all ongoing; Her Diagnosed allergies include iodine fish, Propofol, and preservatives, sleep apnea, had COVID in Jan2021, and had a cough (Jan2021) from that. There were no concomitant medications. The patient previously took iodine, propofol and had allergies. Patient took first dose on 18Mar for reason that patient has lost all allergies that cannot be detected by blood work. After first short she was told to wait an extra 15 mins not vitals taken she can leave a felt like a specimen unpaid but paying with life. Patient started coughing while everyone watched her so she said she better take Benadryl cause she doesn't wanna die. Patient left had off balance couldn't see straight. She was the one that had all side effects from vaccine as well as COVID signs. She had research medicine/food that cause her to have anaphylaxis. Patient found same ingredients in vaccine but food and drug said it ok. Patient was an experiment. She need to no from your board it is ok for me to take 2nd vaccine. Patient should be getting paid. Her doctor making it seem it up to her she gotta go out and get and epi pen she cant afford. In running out of gloves and mask. The patient experienced Anaphylaxis, has been trapping food since in her throat, headache with numbness, Cough, blurred vision and nausea from headache, all on 18Mar2021. Caller has been coordinating with the CDC by email. Since day one she had a bad reaction to the COVID vaccine. This has been going on a month now. The CDC advised her not to get the second shot. She has went back and forth with the doctor. She had anaphylaxis from the vaccine. Her throat closed. She had irritation in her throat. She has been trapping food since in her throat. This has been since the anaphylactic reaction. She has to chew her food as fine as possible. She tries not to eat that much. This is still the same. It hasn't improved or worsened. She has also had a headache with numbness that is pretty much 24 hours a day. This started right after. She really felt it the next day. She tried to take Tylenol for four days, three times a day, and nothing happened. It was not going away. Her doctor also put her on a migraine medication, but it didn't work either. The headache has worsened over time. No medication is helping, and the doctors are confused. The migraine medicine is not helping. Her pressure is going up and down. She is wondering if she needs an emergency echo to see what is going on. She is still having bad effects. No doctor knows what to do. She has been to a lung specialist. Her cough just keeps getting worse. The cough started to get worse after the vaccine. She had COVID in Jan2021, and had a cough from that, but the vaccine made it worse. It is a ruff cough. She is on cough suppressant medication. Caller did not have a prescribing doctor. She got it at the hospital. She figured that was the safest, and since she is a patient there they emailed her because she was eligible to get it. She is mostly calling because the doctors don't know how to help. She is about to pass out from this headache. She is even losing vision from the headache. She feels like she is going to have a heart attack before her time. They are trying to figure out why her head is hurting. They do not think it is a migraine. Her headache is a 9/11 or a 10/12. She feels like after the vaccine she has been chemically off balance. She wants to get her thyroid checked too. Mostly because her food is getting trapped in her throat. Her throat is irritated and hoarse. The headache has given her blurred vision, and a felling like she is going to throw up. She feels off balance from the blurred vision. Caller had difficulty seeing information on Tylenol and Nurtec. She asked her husband to help. They cannot read the lot on the Tylenol. She has been to so many specialists to try to find answers, and no one has a clue. She saw on Pfizer's paperwork that she needs to reach out to a immunologist. Her allergist had no clue. From the world trade centers falling she has ongoing issues from that. She has sleep apnea, allergies, asthma, etc. She spent 30 minutes being monitored at the hospital. She had started coughing. Her husband said she needed water. She always carries Benadryl with her. Finally she felt like she needed to take her Benadryl. It saved her. She knows the Benadryl probably won't work forever, but she cannot afford an epi Pen. Time of Onset (24 hours clock): right after vaccine (18Mar2021). All events require a visit to Physician Office. She didn't have to go the ER. She was lucky with the Benadryl. She takes Benadryl with her everywhere even to restaurants. No Prior Vaccinations (within 4 weeks). Treatment received for coughing, headache with numbness, blurred vision and nausea from headache. The outcome of the event has been trapping food since in her throat, had irritation in her throat, headache with numbness, blurred vision and nausea from headache was not recovered, for other events was unknown.
56 2021-05-10 pain in extremity, feeling hot she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; ... Read more
she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; her heart is beating fast and she is nervous.; burning sensation in her ear; tiredness; headache; heaviness on her back and chest on the left side; heaviness on her back and chest on the left side; no appetite; nauseous; diarrhea; throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh she could feel crushing and throbbing; her heart is beating fast and she is nervous.; sharp pain in her thigh/pinching sensation on inner thigh; sick; throbbing; muscle pain; weird sensation; throbbing sensation to the left side of her belly button/It was like at her stomach; fever of 100.3F; had a feeling of heat on her neck, face, and ears; redness and itchiness at the injection site; redness and itchiness at the injection site; the injection was large, red, hot, and itchy; the injection was large/ the swelling went down; dizzy; This is a spontaneous report from a contactable consumer reported herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included disability, obese, covid-19 when she was sick with COVID last year, she has never been that sick. she thinks she made it through because she owns a nebulizer and can say her lungs have never felt like they were full of fluid. If anything, they felt heavy. It was heavy in her back and chest. She also had a fever. She guesses she would be considered obese. Concomitant medications included paracetamol (TYLENOL). The patient received the first dose of the Pfizer COVID vaccine last week and she has experienced several side effects and is very anxious and nervous. She experienced redness and itchiness at the injection site, pinching sensation on inner thigh that she thinks may be blood clot or a muscle but not really sure, fever of 100.3F from 24Apr2021, burning sensation in her ear, tiredness, headache, heaviness on her back and chest on the left side, no appetite, nauseous, diarrhea, had a feeling of heat on her neck, face, and ears, throbbing sensation to the left side of her belly button from 26Apr2021 and she felt dizzy from 22Apr2021. The patient stated there was a bad connection and she was having difficulty hearing. The patient was a little nervous. Maybe this was a psychosomatic issue and she was thinking of things too much. She was sick for 5 weeks. She was never in the hospital or intubated. The site where she had the injection was large, red, hot, and itchy. It was from 22Apr2021 (Thursday) for the next maybe 3 days. Now the color is diminishing, the color is going down more like to pink and smaller and it not itching anymore. Once in a while she got a pinching sensation on her inner thigh ever since she had the injection. In the last couple days, she has been feeling a that a little more. She wanted to make sure it was not a symptom of a blood clot. She doesn't feel short of breath. She was nervous talking the call handler so that is why she is talking fast. She doesn't want to feel so sick like she did last year when she had it in March or April. She wanted to know that it's not a symptom of a blood clot. It was a throbbing pinching pain that goes and doesn't come back for a little bit, but it might come back a little bit later. It happened when she woke up. She has no swelling in her legs or thighs or anything else. She says she would not be talking this fast, but her heart was beating fast and she was nervous. She tended to be an anxious and nervous person. The patient never had blood clot issues. She wanted to make sure with everything that she has heard about Pfizer she hasn't heard of anyone having blood clot issues. She had to read to calm herself down a bit. It is a sharp pain with throbbing that comes and goes. She didn't read where it could be a blot clot, she just wanted to know. She is horrible at running to the hospital when she feels something because she gets so nervous and she thinks knowing is better because she's a realist. It takes her a minute to go to the hospital to figure it out. If she continues to feel like this she and her daughter will go to the emergency room. It is 5 blocks away. It is a small little hospital and they will be able to ease her mind. It could be her nerves getting to her too. Her fever got up to 100.3 and that was only on Saturday, 48 hours after the vaccine. Once she took Tylenol it was gone and didn't return again. She took her temperature; it was a beeping one. She always says she would take like 2 out of 3, and every time she took it went up. She felt a weird sensation of burning in her ears, the same as when she first had Covid, feeling like a fever. It brought her back to a bad place and it freaked her out. She is on disability and has people go to the store for her. She did that for 3 to 4 months. She is not agoraphobic, but she hadn't gone out until she got the vaccine. It took her all day to get back home because she loves the outdoors. It is kind of sad, and she knows she is not the only one who experienced that. She was able to actually stay at home, and when she went out, she wanted to stay. She still has her second dose to take, not everyone in has this and she doesn't want to feel that sick again. Eventually she will perish away one day, from God knows what but a slow death of not being able to breathe she cannot picture for herself or anybody else. She tries not to watch the news, it was depressing, because it is all over the news, she tries to stay in the loop. She was tired and had a headache. She took Tylenol and slept for an hour or hour and half. When she woke up she felt heaviness on her back and chest on the left side, and as she moved around more it was on her back and less on her chest. It was the same as she felt when she had Covid. She didn't have any aches or pains. The other thing was she had no appetite for the next 3 days. Every time she woke up, she felt extremely nauseous but had nothing to vomit. For the next 3 days or 72 hours, she had diarrhea. If she ate anything, she was in the bathroom. On 24Apr2021 (Saturday) after 48 hours she started to feel the heat in her neck and face and ears like right on her ears. She was talking to her daughter and her daughter said these are normal. Where she got the injection was itchy and a little more red. She told herself not to scratch it in her sleep, she is one of those people if something itches, she scratches. What she would do is rub her arm up and down on the site. It was almost the size of an 8 ounce tomato sauce can or maybe the size of a baseball. Then the third day it got redder. In her sleep she was rubbing her arm because it got itchy. Today the swelling went down, the color is like a light pink, and the size is also minimized. The fever lasted that night. She took her temperature again the next day and it was 97.9. That is usually what it is when she wakes up. She is not just tired; she is exhausted and feels like she has to go to sleep. Her daughter came with her granddaughter who is a baby, and she didn't know how to tell them. She was happy to see them but so exhausted. She worries about the sharp pain in her thigh. The other thing is she started getting pain in the middle of her thigh, her inner thigh. A sharp pain with like a throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh, she could feel crushing and throbbing. She can feel it from touching the area. She had this before like when she is stretching. It started maybe 3 months ago and went away but then after she took the injection and heard about thing, she worried about a blood clot with Johnson & Johnson, not that she would know because she has never had a blood clot. It could be psychosomatic and all working in her head. It started the last 2 days when she woke up, she felt fine and as she was lying in bed, she started feeling a sharp throbbing pain that eventually goes away. She has no swelling of her legs or thighs, and her daughter said it looks fine. She is semi-terrified of hearing bad news. It takes her longer to go to the hospital. If she starts feeling worse, she will be there in no time. She does not want to wait until it is worse, but she does not want to spook herself into going. She suffers from anxiety. She definitely had the fever not like she was just tired it was like she was exhausted. She got up early and would take a little nap because she was doing a bunch of stuff. That hasn't happened, but that's her. It will be 2300 when she goes to sleep. She was doing a bunch of stuff and felt like she just needed to take a nap. Maybe it is part of that too, but usually she doesn't feel tired like this. After her daughter left, she read something on her phone and passed out. When she woke up, she saw she actually dropped her phone. Her thigh is now not a pinch but more a little bit of a muscle pain. Now it is not like the inner thigh, it is more behind the thigh now, but not below the knee, right behind the thigh, closest to the knee but not on the knee. It is the same thing as if the middle had gone behind her thigh a bit. The little pillow on her chair is not helping anything either. It feels like it maybe muscular, its deep feeling. It feels like it could be muscle, if she rubs it, she can feel it. When asked has it improved persisted or worsened, caller states it is there, but it is dull. She can say there is pain, but it is a little duller just because it is more in the muscle. It is hard to explain, it was not the same throbbing pain but there is a dull pain, it goes around the chunkier part of her thigh, like the inner thigh. When she rubs it there is pain but a dull pain. When she rubs it, it feels better but she can still feel the site where it hurts. When she rubs it, it is still located right in the lower middle going toward her knee but not at the knee, maybe 3 to 4 inches away from the fold of her knee, almost at the center of her thigh almost. Almost like a dull muscle ache, there is a bit of throbbing with it. She will go to the doctor if something weird happens and will call back when they have an idea of what happened to her. This will sound crazy. The next thing she felt was a light throbbing where her belly button is but more to the left side, but not at the belly button. It was like at her stomach, not right at the belly button but right on the same line as her belly button but more at her waist. It was a small throbbing started today about an hour ago. She is hoping it is gas. Her fever went away pretty fast. She was on the phone and took her temperature to tell what it was. The woman said to take some Tylenol. It went from 99.9 to 100 to 100.3. She thought oh no. That was the highest she saw. Then eventually it started going down to 99.4, and then by morning it was back to normal. She only took Tylenol the one time. She is thinking maybe it is from being nervous and causing her body to heat up. She doesn't know she is just thinking. She thinks the fever went away the same day within an hour to 2 hours. She also wasn't drinking enough water. When asked if her fever has recovered completely or with last effects, caller states that is fine now, her temperature today was 99.4 without the fan on, she says she thinks that was pretty normal. When she first wakes up it is 97.9 usually. There was also a 98.4. The redness and itching at the injection site started 3 hours after the injection. She took her 2 sons with her. She took it and then her son took it. They said to wait 15 minutes. As soon as she stepped out, she looked up and felt so dizzy. It looks like when in summer and it seems to be boiling hot, that is how it got for her. Things got blurry. It was not like she was going to black out, but she had to close her eyes because the room was going to spin. She knocked back on the door and took a seat, so she sat down because she was not feeling right. When she gets nervous, she chews gum as a coping mechanism. Her son got some gum for her. She felt better but kind of nervous waiting for 15 minutes to go by, what if she felt dizzy again. She let 20 minutes go by and she got up and was fine. She wanted to be out of there and in the cool air outside. That is the first reaction that she had. She is one of those people that feel so nervous she is sure that happens that they feel like, oh they are so nervous, and they read so much, and it is in our faces everyday no matter what. Maybe it had nothing to do with the injection, maybe more that she was so nervous, but it was a weird sensation after. She knows when people first started getting the COVID vaccine, people were just like falling to the ground, she was like that would be terrible. She went with high expectations and was also nervous. Her heart was beating, and she could hear her own heartbeat. She still feels tired and like she can go take a nap now. She asks if that is normal. She would rather talk to Medical Information now. She is over this statistics part of it. She doesn't feel a release, she is just giving her information and she doesn't feel any better. Outcome of the event throbbing sensation to the left side of her belly button/It was like at her stomach was not recovered; of the event dizzy was recovered; of the events the injection was large, red, hot, and itchy/ the swelling went down, tiredness was recovering; of the other events was unknown. Information about lot/batch number has been requested.
56 2021-05-10 pain in extremity Chills; Shingles; Arm pain; Headache; fatigue; This is a spontaneous report from a contactable consu... Read more
Chills; Shingles; Arm pain; Headache; fatigue; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer (patient) reported that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8727; expiry date 31Jul2021) single dose at left upper arm muscle on 28Mar2021 14:00 or 15:00 for COVID-19 immunization. Medical history included Shingles. Concomitant drugs were not provided. The patient got shingles on 05Apr2021. She got shingles blisters and the swelling was mostly gone, just about cleared. It was not completely gone she still has a few spots left from the shingles. The event required physician office visit as she wanted her doctor to look at the Shingles before she got the second vaccine. The doctor said she could get the second vaccine. She had shingles in the past. Her doctor did not feel that it was related to vaccine, but she wanted to report her symptoms. She took valacyclovir HCL (generic for Valtrex) for shingles. One gram tablet by mouth twice a day. There were 20 tablets total. She has arm pain and headaches on 28Mar2021, fatigue in Mar2021 and some chills on unknown date. She experienced arm pain after the first vaccine, which lasted for about 3 days. The pain decreased each day, but is unsure when it went away. She also started to feel fatigue within that week of the first vaccine, and subsided that same week. She had chills the week of the first vaccine, and went away that week. She had a headache the same day of the first vaccine and persisted that week. She did not treat her other symptoms, just drank water. Outcome of shingles was resolving, arm pain was resolved on 31Mar2021, fatigue and chills was resolved in 2021, headache was resolved on 20Apr2021. No follow-up attempts are needed. No further information is expected.
56 2021-05-10 pain in extremity Couldn't raise her left arm, the pain in her muscle; Couldn't raise her left arm, the pain in her mu... Read more
Couldn't raise her left arm, the pain in her muscle; Couldn't raise her left arm, the pain in her muscle; Pain went up into her neck; Headache; Muscle pain; Cold-like symptoms; Lost her voice; Coughing non-stop; Not feeling well; She was just tired from all the probing and injection; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 12Apr2021 (Batch/Lot Number: EN6198) as single dose for Covid-19 immunisation. Medical history included joint injury from an unknown date (patient will have knee replacement on 26Apr2021). The patient's concomitant medications were not reported. On the night of the same day of vaccination, patient stated she started not feeling well. She assumed she was just tired from all the probing and injection and all that stuff so she wasn't feeling well on 12Apr2021night, she just assumed she was tired and had a busy day. On the following day, 13Apr2021, patient couldn't raise her left arm, the pain in her muscle, then it went up into her neck, her neck still hurts, she also had headache, muscle pain, cold-like symptoms, and then she lost her voice, and has been coughing non-stop since 13Apr2021. Outcome of event couldn't raise her left arm, the pain in her muscle was recovered on 16Apr2021, pain went up into her neck, cold-like symptoms, cough, lost her voice was not recovered, of headache, muscle pain was recovering, of other events was unknown. The patient underwent lab tests and procedures which included blood test normal on 12Apr2021. Patient states she is scheduled for the second dose on 13May2021 at her post-op visit. No follow-up attempts are needed. No further information is expected.
56 2021-05-10 tingling, numbness After the first shot in left arm I felt tingling in my left hand and fingers, the pointer, middle an... Read more
After the first shot in left arm I felt tingling in my left hand and fingers, the pointer, middle and ring finger felt numb and tingly for two weeks, then my toes my right foot started feeling tingly and numb , my second and third toes are the ones that I keep experiencing the numbness with.
56 2021-05-10 trigeminal neuralgia On 24th onset of severe pain on trigeminal nerve and fever of up to 101. Continued through 25th, wen... Read more
On 24th onset of severe pain on trigeminal nerve and fever of up to 101. Continued through 25th, went to Urgent care on 26th. Started on prednisone. Assumed just a trigeminal flare up. Then blisters erupted on gum and roof of mouth on 27th making it clear it was shingles. Started on antiviral (valtrex) that day. I had chicken pox as an adult in my mid 20s and have had two bouts of shingles before this. This was the worst by far. I had the first dose of Shingrex about 2 years before vaccination. Was also given antibiotic on 26th, which I did not take as the doctor said not to as long as it appeared viral. Which it turned out to definitely be. My GP on my visit today said to use the form here to report this.
56 2021-05-11 pain in extremity About an hour after the 2nd dose, I started to feel faint/dizzy/tired/nauseous. After a day, I noti... Read more
About an hour after the 2nd dose, I started to feel faint/dizzy/tired/nauseous. After a day, I noticed arthritic pains in both shoulders. The left arm joint pains went from shoulder to finger tips (prior, I was being treated for stiff finger joints in my left hand). Since the shot, most of the problems have gotten better, but I'm still left fatigued most of the time, and have slightly increased swelling in my left hand fingerjoints.
56 2021-05-11 pain in extremity Swollen lymph glands; fatigue; soreness behind her eyes; light sensitive; Arm pain; chills; headache... Read more
Swollen lymph glands; fatigue; soreness behind her eyes; light sensitive; Arm pain; chills; headache; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 0.3 ml injection, Lot#: EW0162, Expiration Date: 31Jul2021) at single dose on 18Apr2021 12:50 in left upper arm muscle for COVID-19 immunization. The first dose was on 28Mar2021 (Expiry Date: 31Jul2021) at 1400 or 1500, and experienced shingles, arm pain, headache, fatigue and some chills. Medical history included shingles in the past, with the second vaccine patient had just cleared up from the shingles. Patient clarified shingles was pretty cleared up, it was not active and doctor said she could get the second vaccine. There was on other products taken. Prior vaccinations (within 4 weeks) was no. Patient experienced swollen lymph glands on 20Apr2021; arm pain, chills and headache on 18Apr2021; fatigue and soreness behind her eyes on 19Apr2021. Days later she got the second vaccine, patient was having regular side effects of arm pain, fatigue, and swollen lymph glands. She had gotten shingles before, and sometimes it popped up at different times. She didn't have other underlying condition like some people who had immunodeficiencies or arthritis. The arm pain after first and the second vaccine started the day of the vaccine. That arm pain from the second vaccine woke her up at 3am, it was so bad. It seemed to subside more quickly. Today it's still there, but not as bad. It was almost not noticeable. Patient felt more fatigue after the second vaccine today and yesterday. She felt more fatigued today and clarified it was persisting as of now. The lymph glands felt tender in her neck, which started today and was ongoing. Patient also had chills after the second vaccine, but was improving. Patient also had a headache after the second vaccine, which resolved today. It also felt sore behind her eyes. Patient stated it had to happen with her in the past as a flu symptoms. They were light sensitive, and if she moved them to the right and left she had soreness behind her eyes. This started yesterday and was ongoing. She did not have the soreness behind her eyes with first dose. She was not sure if it's associate with the headache. The outcome of events arm pain and chills was recovering. The outcome of event headache was recovered on 20Apr2021. The outcome of rest events was not recovered. No follow up attempts are needed. No further information is expected.
56 2021-05-11 tenderness Left flank pain and tenderness.
56 2021-05-12 feeling hot 3 weeks almost 4,joint pain.Severe in hands and wrists..feet and ankles...elbows and knees less.But ... Read more
3 weeks almost 4,joint pain.Severe in hands and wrists..feet and ankles...elbows and knees less.But sharp hot shooting pain pain randomly in palms of hands and arch of feet a few times...also very fatigued...tired!
56 2021-05-12 flushing, numbness 1005-Called to 30 minute observation; MD and EMT responded. 1st vaccine 1008-hard to swallow, dizzin... Read more
1005-Called to 30 minute observation; MD and EMT responded. 1st vaccine 1008-hard to swallow, dizziness, feeling "unwell"; fullness in ear, flushed BP 187/118; tolerating water 1011- 164/90BP no chest pain, shortness of breath, numbness, dizziness, blurry vision, n/v 1017-Feeling better, have dry throat, MD sitting with patient 1020- Pt stated she is feeling great, denies any symptoms, elected to leave pit with her husbands. Treatment/Outcomes: Allergies: seasonal; sulfa MHx: Hashimoto's, gallbladder removed Meds: 'hormones" and thyroid
56 2021-05-12 migraine Major Migraine headaches with nausea started on May 7, 2021, additional migraines on May 9, 2021, M... Read more
Major Migraine headaches with nausea started on May 7, 2021, additional migraines on May 9, 2021, May 11, 2021 continuing through May 12, 2021.
56 2021-05-12 muscle twitching Approx. 24 hrs after 2nd Pfizer Covid-19 vaccine, I experience a fever, nausea, no appetite, severe ... Read more
Approx. 24 hrs after 2nd Pfizer Covid-19 vaccine, I experience a fever, nausea, no appetite, severe headache, fatigue, and tinnitus w/itching in right ear. 24 hours later the fever and nausea were gone, headache and tinnitus lingered. 24 hours later just fatigued and tinnitus and itching in right ear. Now almost 5 weeks post 2nd Covid vaccine, tinnitus and itching in right ear still persists.
56 2021-05-13 numbness Pt received dose 1 of Pfizer covid vaccine, and immediately upon trying to stand, experienced lighth... Read more
Pt received dose 1 of Pfizer covid vaccine, and immediately upon trying to stand, experienced lightheadedness and said her vision blacked out briefly. She then stated she had lip numbness and lower face numbness. Pt further stated her BP sometimes drops rapidly and causes her to pass out, but she never experienced it with a vaccine previously. Pt requested Gatorade and was monitored for 30 minutes, at which time she stated she was fine, and left with spouse.
56 2021-05-13 nerve pain Onset on Shingles- began on stated date, with severe nerve pain in upper back, traveling down arm to... Read more
Onset on Shingles- began on stated date, with severe nerve pain in upper back, traveling down arm to fingers, followed by breakout of rash. Currently being treated with Valtrex, Gabapentin and Mobic and currently having debilitating weakness in hand and unable to grip and type on laptop without making mistakes. Affecting my work. (first dose was on 4/4/21 and second on 4/23/21
56 2021-05-13 tingling Following 15 min observation period, patient reported tingling face and lips and throat closing. Pr... Read more
Following 15 min observation period, patient reported tingling face and lips and throat closing. Prior to vaccination, patient was nervous and reported anxiety regarding the vaccination. Vitals 6:39 p - BP 170/85, SpO2 95%, 71 bpm 6:50 p - BP 156/81, SpO2 96%, 78 bpm 6:55 p - BP 135/73, SpO2 96%, 80 bpm Patient reported tingling went away; left clinic with daughter who could drive.
56 2021-05-13 tremor On Wednesday (May 12) morning after receiving my 1st COVID-19 Vac - I felt the sensation of my uppe... Read more
On Wednesday (May 12) morning after receiving my 1st COVID-19 Vac - I felt the sensation of my upper body "slightly" vibrating but didn't over think it because I was driving. Later that evening while sitting home with family - I was able to confirm my physical body was slightly vibrating. Thursday, I reported this symptom to my doctor she recommended that I report the details to the CDC. If you have any questions or concerns please contact me via email or phone. Thanks
56 2021-05-14 breast pain Shingles along the T4 dermatome pathway/red eruption; Burning, stabbing pain in left breast spreadin... Read more
Shingles along the T4 dermatome pathway/red eruption; Burning, stabbing pain in left breast spreading to outer side and al along left upper back; Burning, stabbing pain in left breast spreading to outer side and al along left upper back; This is a spontaneous report from a contactable physician (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in Arm Left on 01Mar2021 13:15 (Lot Number: EL 3247) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. On 08Mar2021, the patient shingles along the T4 dermatome pathway, one week after vaccine dose. Burning, stabbing pain in left breast spreading to outer side and al along left upper back. Noticed red eruption 2 days ago and went to PCP who diagnosed as shingles. The events resulted in doctor or healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect. The outcome of the events was recovering. The events were treated with Valtrex 1GM TID for 7 days and Prednisone 20 mg 2 tabs once a day for 5 days. No follow-up attempts are needed. No further information is expected.
56 2021-05-14 slurring, flushing Delirium; swelling inside of throat; dizziness; Slurred speech; neck pain; flushed skin; Heart palpi... Read more
Delirium; swelling inside of throat; dizziness; Slurred speech; neck pain; flushed skin; Heart palpitations; Headache; worse throat itchiness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 28Apr2021 15:30 (Lot Number: ER8736) as 2nd dose, single for COVID-19 immunization. Medical history included myocarditis from COVID, elevated BP and known allergies: Cipro and IV contrast dye for CT scans; all from an unknown date and unknown if ongoing. The patient previously took BNT162B2 (lot number: EW0150), 1st dose, on 07Apr2021 04:00 PM in the left arm for COVID-19 Immunization and experienced swelling inside of throat, dizziness, slurred speech and delirium at 56 years old. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had other unspecified medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Apr2021 04:45 PM, the patient experienced swelling inside of throat, dizziness, slurred speech, delirium, immediate base of neck pain, flushed skin, heart palpitations, headache and worse throat itchiness. The patient did not received treatment for the events. The outcome of the events was recovered on unspecified date. Information on lot/batch number is available; additional information has been requested.
56 2021-05-14 slurring delirium; swelling inside of throat; dizziness; slurred speech; This is a spontaneous report from a ... Read more
delirium; swelling inside of throat; dizziness; slurred speech; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EWO150), via an unspecified route of administration, administered in arm left on 07Apr2021 at 16:00 (at the age of 56-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included myocarditis from COVID, elevated BP and allergies to IV contrast dye for CT scans, all from an unknown date and unknown if ongoing. Concomitant medications included other medications (unspecified). The patient previously took cipro and experienced allergies. For both shots, the patient experienced swelling inside of throat, dizziness, slurred speech and delirium on 07Apr2021 at 16:45. There was no treatment received for the events. The outcome of the events was recovered on an unspecified date.
56 2021-05-14 numbness, tingling she can't grip she can still grip things but she has to shake her arm to wake it up; A feeling of pi... Read more
she can't grip she can still grip things but she has to shake her arm to wake it up; A feeling of pins and needles at the finger tips; Hand was numb and tingly; Hand was numb and tingly; Arm felt like it was falling asleep/felt like her arm was going to sleep; Arm is going numb; Her hand and is like it is falling asleep; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer (patient) reported that: A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982) via an unspecified route of administration in left upper arm on 22Jan2021 at 14:45-15:00 as single dose for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination) and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 she reports that her arm is going numb and her hand and is like it is falling asleep. On Monday(25Jan2021) she had to shake it to wake it up, arm felt like it was falling asleep and her hand was numb and tingly, she had the same feeling in the arm she had the injection. Tuesday and Wednesday it was ok and she had no issues but today(28Jan2021) felt like her arm was going to sleep. She had to shake it to wake it up and there was a feeling of pins and needles at the fingertips. It is not like she can't grip she can still grip things but she has to shake her arm to wake it up. She wants to know is this some known side effect and is it safe to have the shot in the same arm, her second dose is due on 08Feb2021. Outcome of the events were unknown.
56 2021-05-14 numbness, tingling this time she began to pass out; tingly sensation in her left arm and left hand; numbing feeling; br... Read more
this time she began to pass out; tingly sensation in her left arm and left hand; numbing feeling; brain has a swooshy feeling; she was in a position of where she might pass out; did not feel so great; she felt weird; like she is groggy; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 28Apr2021 at 14:00 (at the age of 56-years-old) as a single dose in the right arm for COVID-19 immunisation. Medical history included car accident in 2019 (two years ago; she slammed her hand into the steering wheel and she was not sure if that was the injury that caused her hand to hurt like arthritis), arthritis from an unspecified date and unspecified if ongoing and history of passing when she gets shot or blood drawn as a young girl from an unspecified date and unspecified if ongoing. Medical history (including any illness at time of vaccination) and family history relevant to the adverse event were both reported as no. The patient stated that she had never had symptoms or adverse events after prior vaccinations. Concomitant (other) products were reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine or on the same date as the COVID-19 vaccine. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8737) via an unspecified route of administration on 06Apr2021 at 12:15 (at the age of 56-years-old) as a single dose in the right shoulder upper arm for COVID-19 immunisation and experienced she felt high, inflamed bursitis in the knees, could not walk, felt a little depressed, could not form words very well, she felt sleepy and her arm and her hand was hurting. On 28Apr2021 the patient experienced this time she began to pass out, tingly sensation in her left arm and left hand, numbing feeling, brain has a swooshy feeling, she was in a position of where she might pass out, did not feel so great, she felt weird and like she is groggy. The clinical course was reported as follows: The patient stated that she was supposed to wait 15 minutes after getting the second dose of the vaccine and within a few minutes she had a tingly sensation in her left arm and left hand that was more so towards the pinky and her ring finger area. She used to have a history of passing when she got a shot or blood drawn as a young girl, but as her brain had experienced this over and over again she had been fine; however, this time she began to pass out. Since she knew it was coming with the tingling, she knew it was not normal, so she immediately went and told the employees that she was in a position of where she might pass out. So, she laid down and did not feel so great, but probably 20 minutes went by and she felt weird. It took her 45 minutes to decide to sit up and then 15 minutes later she left. The tingly sensation in her left arm and left hand was gone, but she had a left-over numbing feeling. The patient also reported that her brain had a swooshy feeling, like she was groggy, and she did not want to turn her head too fast because she felt like she would not like it. Relevant tests were reported as no. The clinical outcomes of the events this time she began to pass out, tingly sensation in her left arm and left hand, she was in a position of where she might pass out, did not feel so great and she felt weird were recovered/resolved on 28Apr2021 while the clinical outcomes of the events numbing feeling, brain has a swooshy feeling and like she is groggy were not recovered/not resolved.
56 2021-05-15 numbness, tingling On 5/6/21, patient developed BLE progressive weakness, numbness/tingling, then progressed to BUE num... Read more
On 5/6/21, patient developed BLE progressive weakness, numbness/tingling, then progressed to BUE numbness/tingling weakness, presented to Hospital 5/8 ED, discharged, then presented to 5/9 Hospital, eventually diagnosed with AIDP / GBS. Given IVIG 5d course through 5/14. Required mechanical ventilation 5/14. Pending ongoing management at Hospital Neurologic Intensive Care Unit
56 2021-05-16 cold sweat AT 13;15, CLIENT COMPLAINED OF TACHYCARDIA, BP WAS 167/95, PULSE 75 ABD O2 SAT 100%. PER PATIENT S... Read more
AT 13;15, CLIENT COMPLAINED OF TACHYCARDIA, BP WAS 167/95, PULSE 75 ABD O2 SAT 100%. PER PATIENT SHE TOOK PROPRANOLOL AT 0900 AM FOR HTN. SHE WAS COLD AND CLAMMY AND WERE OBSERVED BY TWO NURSES-LVN. AT 1340, BP WENT DOWN TO 126/88 AND OF THE FACILITIES WERE INFORMED AND TOOK PATIENT TO THE ROOM. WE JUST FOUND OUT THAT CALLED 911 AT 2:30 PM. PER , SHE SPOKE TO THE PATIENT WHO STATED SHE DOES NOT WANT 911 TO BE CALLED, BUT DID ANYWAYS. MADE ON 05/15 AND 05/16 TO CHECK ON PATIENT, LEFT A MESSAGE.
56 2021-05-16 facial paralysis, bell's palsy Bell's Palsy started on 5/13 after vaccination on 5/10. Subtle ptosis progressed to facial nerve par... Read more
Bell's Palsy started on 5/13 after vaccination on 5/10. Subtle ptosis progressed to facial nerve paralysis by 5/16/21.
56 2021-05-16 numbness Approximately 20 minutes after receiving her second Pfizer vaccine patient began feeling numbness/ti... Read more
Approximately 20 minutes after receiving her second Pfizer vaccine patient began feeling numbness/tingling of lips and "itching everywhere". Noted to have edema under eyes bilaterally. Gave Benadryl 25mg orally at 1408 and shortly after moved patient to a private area to monitor and have her lay down. While ambulating pt began to feel dizzy, wobbly and her feet became numb. Pt . began talking as if her tongue was thick and swollen. Laid pt on couch with feet elevated. Administered Epi Pen autoinjector into rt. lateral thigh at 1415. Called 911 EMS. Lip swelling, eye edema and tongue edema began decreasing. Pt never felt short of breath. Feet remained feeling numb. Vitals: 1410 BP: 160/100 Pulse: 74 Oxygen sat: 98%. 1418 BP: 172/102 Pulse:84 O2 Sat: 97% 1424 BP: 174/100 Pulse: 83 O2 Sat: 98%. Pt transported by ambulance with paramedics at 1432.
56 2021-05-16 numbness Right side of top lip went numb. Right side of nostril opening went numb . Occurred after 2nd dose.
56 2021-05-16 pain in extremity, muscle spasms Pt reports the next day post 2nd dose left arm sore, achy and pain with movement and sometimes hard ... Read more
Pt reports the next day post 2nd dose left arm sore, achy and pain with movement and sometimes hard to move (spasm in left arm). When she stays still there is no pain. Her entire body is achy still, pt reports "feeling broken". She reports her pain level is a 10. She also reports intermittent GI issues - cramps and nausea. Pt reports she had applied some bengay to help alleviate the pain which she reports it only helped for ~30 minutes to 1 hour. Pt reports she called her MD and was advised to contact us.
56 2021-05-16 pain in extremity Still feels bad 3 weeks post-vaccine-achy, difficulty walking more than 60 feet due to weakness/pain... Read more
Still feels bad 3 weeks post-vaccine-achy, difficulty walking more than 60 feet due to weakness/pain in heart, headache 5-6 times per day, pain in left hand and neck Started with tachycardia 4 days post vaccine. Metallic taste 6 days post vaccine, facial allergy 8 days post vaccine, painful swelling in left leg 11-12 days post vaccine
56 2021-05-16 tingling, numbness Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, A... Read more
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling, feeling numb on left arm post 2nd dose Pfizer vaccine
56 2021-05-17 tingling Since the 1st vaccine, I have experienced intermittent tingling of my fingers; This is a spontaneous... Read more
Since the 1st vaccine, I have experienced intermittent tingling of my fingers; This is a spontaneous report received from a contactable nurse (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), intramuscular in left arm on 03Jan2021 (at the age of 56-year-old) as 1st dose, single for COVID-19 immunisation. The patient was not pregnant. Facility vaccine type was reported as hospital. The patient's medical history included hypothyroidism, psoriasis, hyperlipidaemia (HLD), all from unspecified date. No COVID prior vaccination was reported. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), from unspecified date. No other vaccines were received within 4 weeks from vaccination. The patient previously took propylthiouracil (PTU) and tapazole, both reported as known allergies. It was reported that since first vaccine, she had experienced intermittent tingling of her fingers on 10Jan2021. No treatment was received for the event. It was also reported that patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), administered in right arm on 24Jan2021. The patient had not been tested for COVID post vaccination. The outcome of the event was not resolved. Follow-up (12MAY2021): Follow-up attempts are completed. No further information is expected.
56 2021-05-17 tenderness, pain in extremity I was given the Pfizer Vaccine at the hospital on both separate occasions. I had an adverse reactio... Read more
I was given the Pfizer Vaccine at the hospital on both separate occasions. I had an adverse reaction w/ the second vaccine - about 4 to 5 days after given the shot, I developed a large swollen gland the size of a golf ball on the right side of my neck, also the glands under my right arm were swollen as well. It was tender and painful. The shot was administered on my right arm.
56 2021-05-18 weakness, tremor Weakness, feeling like maybe getting a headache. Altered sensation in throat. Seen by EMS on site 16... Read more
Weakness, feeling like maybe getting a headache. Altered sensation in throat. Seen by EMS on site 16:45 HR 100 regular Spo2=99% BP=148/116 17:00 HR 98 regular Spo2=100% BP=131/93 Reported resolved symptoms, c/o "shakiness" prior to departure. Discharged home at 17:05 p.m. Recorded by RN.
56 2021-05-18 pain in extremity Broke out all over with rash started with underarms then moved/broke out in a mid rash but it was he... Read more
Broke out all over with rash started with underarms then moved/broke out in a mid rash but it was head to toe; Itching; Arm soreness; Fatigue; Mild fever; Achiness; This is a spontaneous report received from a contactable consumer reported for herself. A 56-year-old female patient (non-pregnant) received first dose bnt162b2 (Bnt162b2, Solution for injection, Lot number: EN6207, Expiration date was not reported) via unspecified route of administration in left arm on 18Mar2021 at 3:45 PM at first dose single for covid-19 immunisation. The patient relevant medical history included Hashimoto thyroid disorder. The patient has allergy to amoxicillin or benzonatate and broke out with hives while taking both. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines 4 weeks prior to administration of COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID), spironolactone, calcium and ergocalciferol (VIT D) and Krill. Since the vaccination, the patient has not been tested for COVID-19. On 19Mar2021, the very next day after vaccination, the patient experienced fatigue, mild fever, arm soreness, achiness and then the next day was fine. Then a week later on 25Mar2021 13:15 she broke out in a mild rash, she literally started breaking out on the inside of her arms, it went from head to toe and moved all over body. The itchiness lasted for 4 days but was better each day. She said the rash/itchiness is similar when she had an allergic reaction to amoxicillin. The patient was confused about taking the second dose of vaccination due to reaction after first dose. She spoke to her doctor about it, and he suggested not to take the second dose of the vaccine but her son's pediatrician suggested to contact Pfizer for the same. The events rash all over and itchiness were considered as medically significant. Patient received the treatment of Claritin for the adverse events of Itching and rash all over. The outcome of the events fatigue, mild fever, arm soreness and achiness were recovered on 20Mar2021, Itching was recovered on 29Mar2021 and rash all over was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
56 2021-05-19 pain in extremity Patient initially had a sore arm following vaccine and up until 05/18. On the morning of 05/18, she... Read more
Patient initially had a sore arm following vaccine and up until 05/18. On the morning of 05/18, she states she experienced a "spot" on her arm where she was administered the vaccination. On the morning of 5/19, she woke up with hives all over her body. She then called her doctors office to report the hives and was told to take 50 mg of benadryl.
56 2021-05-20 weakness COUGH WEAKNESS NOT MUCH OF AN APPETITE VOMITING
56 2021-05-20 burning sensation, tingling Shingles on cervical left side, rash, burning and tingling
56 2021-05-20 flushing Pt reports face flushed and metallic taste in mouth after receiving the first dose of Pfizer vaccine... Read more
Pt reports face flushed and metallic taste in mouth after receiving the first dose of Pfizer vaccine on 4/20. Pt arrived for 2nd dose today and stated it was discussed with pcp who advised pt to take benadryl before receiving the 2nd dose. Clinical lead called to clarify whether or not she should receive second dose. Vaccine was administered at 3:35pm. 3:40pm pt states she is starting to feel the same symptoms again. Upon assessment face red, sts having an "odd sensation on left side of neck", A&O, BP 102/78, 99% on RA, HR 70. Respiration's even/nonlabored. Denies any difficulties breathing. Refuses transfer to hospital. Pt walked out of clinic at 16:11.
56 2021-05-20 numbness, pain in extremity Headache, sweats, sore joints, pain & numbness down injected arm, nausea, lethargy
56 2021-05-20 nerve pain, numbness, tingling, numbness and pain in extremities At first, throat and lungs were a bit tight for most of a day or two. Other issues started - burnin... Read more
At first, throat and lungs were a bit tight for most of a day or two. Other issues started - burning up and down spine, painful nerve tingling all over - comes and goes. Still going on, but not as much nerve tingling, a month later. Burning in spine still on and off. Peripheral neuropathy. Some numbness in spine, lower spine and leg muscles.
56 2021-05-21 bell's palsy Bells Palsy - left side of face Treated with prednisone and anti viral medication
56 2021-05-22 difficulty speaking Patient received 1st dose Pfizer COVID19 vaccine @ 10:30 AM Around 7PM of the same day she developed... Read more
Patient received 1st dose Pfizer COVID19 vaccine @ 10:30 AM Around 7PM of the same day she developed irritation on the right side of her tongue followed one hour later by swelling of the right side of the tongue with change in voice and difficulty swallowing. Presented to the Emergency Department shortly after and symptoms resolved rapidly with administration of Tranexamic acid @ 0001 on 5/23/21. On the morning of 5/23/21 she had no further symptoms and there was no recurrent tongue edema.
56 2021-05-22 feeling hot, electric shock sensation, tenderness Lymphadenopathy to left armpit - with pain on day 1 , mild warmth, small pea sized nodule palpable a... Read more
Lymphadenopathy to left armpit - with pain on day 1 , mild warmth, small pea sized nodule palpable at 4:03 am . Also had nausea, headache and sharp electrical type sensation to my lower jaw bone that radiated left to right, soreness to left arm of injection. Day 2 only swollen lymph nodes with change in size to kidney bean size and pain still present. Day 3 left side lymph node with 2 sites one pea sized the other walnut sized both painful to touch and noticeable when moving arm during activity. Day 4, both sites still present same sizes and tenderness continues along with mild discomfit during movement with activities.
56 2021-05-22 numbness, migraine That day, felt bad and had migraine. 4 days later, she had numbness and stiffness in hands, slowly i... Read more
That day, felt bad and had migraine. 4 days later, she had numbness and stiffness in hands, slowly improved over several weeks. She also had heart racing- went to ED because thought having MI.
56 2021-05-23 numbness, tingling Numbness and tingling on left side of mouth down to my neck on 04/22/22... Lasted a few days. It jus... Read more
Numbness and tingling on left side of mouth down to my neck on 04/22/22... Lasted a few days. It just happened again 05/23/21. Also, my eyeballs were very swollen and sore. Extremely painful to touch. My sister's lip started twitching after her 2nd dose of Pfizer. I also had a headache for 2 weeks worse than a migraine with fever and chills off and on fir a week. Lastly, tingling and numbness on top of right foot that just started as well.
56 2021-05-23 pain in extremity, pain in extremity She got her vaccine, she told her about the medicine that she had anaphylaxis too, she asked if she ... Read more
She got her vaccine, she told her about the medicine that she had anaphylaxis too, she asked if she had any lip fillers. She waited the 15 minutes and then left, then started with a really bad headache and nausea, which she was fine before that. On the way home her husband wanted to stop and she said no as she was sick, made it home and started throwing up, very tired and went to bed which she never does but was extremely sick. Had fever of 100.1. She would go from sweating to fever, aches and pains, flu-like symptoms, everything hurt, pain in the arm, couldn't use her dominant arm but has lymphedema in the other arm due to having her breast removed due to cancer. Her lips were hurting her and never has chapped lips and had a lot of pain in them. Looked in the mirror on Friday as her lips were really hurting and found they were swollen and her eyes looked like somebody had punched her in them. She called her doctor and they did not return her call. She didn't feel it was anaphylaxis as she did not have any other symptoms. She put ice on her lips, had take a Zyrtec before the vaccine, but did use the Nasacort and couldn't figure out was going on. She had not used anything new on her lips or anything. Was thinking she had partial anaphylaxis. Went online and saw the reactions as they did not give her a list of them. She called her doctor and they told her to go to the ER. She still has some swelling and redness with pain, but not an emergency for her to go to the ER. Her lips are swollen, very tiny flat things in her mouth. Wants to know if she's OK to get 2nd vaccine as her PCP will not call her back.
56 2021-05-23 pain in extremity After the first vaccine, I had the expected headache, fatigue, slightly sore arm, slight nausea, and... Read more
After the first vaccine, I had the expected headache, fatigue, slightly sore arm, slight nausea, and headache which lasted a couple of days. I then developed what felt like menstrual cramping and acidic stomach pain, but I hadn't had a menstrual cycle in seven months, and only two in the past two years. On the 11th day after my vaccination, I had very light bleeding for a day. I didn't connect it to my being vaccinated at all. In the past, I always experienced acidic stomach pain right before my period. I was concerned about cancer so made an OB appointment right away. I didn't see her until two weeks after my second vaccine. I was given the second dose three weeks later on April 21, 2021, and the morning after I had the same side effects as with the first dose--headache, fatigue, slightly sore arm, slight nausea, and headache. Two days later on April 23rd, I began having vaginal bleeding again, only three weeks after the first vaccine. The bleeding was very heavy and lasted for ten days--longer than any vaginal bleeding I'd ever had and much heavier in flow.
56 2021-05-23 tingling Tingling in face, then numbness sensation on lips, numbness sensation on tongueminutes after injecti... Read more
Tingling in face, then numbness sensation on lips, numbness sensation on tongueminutes after injection. Later sensation of palate and tongue having been burned by hot liquid or hot food. Slightly feeling of swollen throat. Altered sense of taste (example coffee did not taste the same as usual) slight loss of smell Feeling winded when breathing. Pain on let side of neck on Sunday. Still numbness and feeling burnt on Sunday
56 2021-05-24 feeling cold Received second dose of Pfizer vaccination on 5/10/21. On 5/11 had severe symptoms all day (cold, a... Read more
Received second dose of Pfizer vaccination on 5/10/21. On 5/11 had severe symptoms all day (cold, achy, chills, fatigue), all expected and manageable. Went to bed at 8PM on 5/11, awoke the next morning (5/12) with a distinct, loud ringing in my left ear. This has not gone away. My concern is that tinnitus is not curable, and this has been persistent without relief. I had to purchase a white noise machine to try to drown out the ringing. It doesn't help much. I saw my physician on 5/18, but there was nothing they could do. They are sending me to an Ear, Nose, and Throat specialist. Hopefully they will have an idea of how to help. This appt is on 6/3.
56 2021-05-24 pain in extremity When the 2nd Covid shot was given to me, it was extremely painful (more painful than any vaccine or ... Read more
When the 2nd Covid shot was given to me, it was extremely painful (more painful than any vaccine or injection I have ever received). My arm was sore for the next two weeks and rather than get better, it's gotten progressively worse. I have pain in my shoulder when I hold my arm out and/or hold my arm up. I cannot hold my arm up over my head without pain. It is so painful at night that it wakes me up at least two or three times a night. I also have pain in my arm when driving. I made an appointment with an Orthopedist (name is given in this report) and his office took an x-ray which showed no arthritis or issue that might cause my pain. He gave me a prescription to go to physical therapy for "shoulder impingement".
56 2021-05-25 pain in extremity Arm pain, large, red, itchy rash in area of the vaccination. Swollen supraclavicular lymph node on ... Read more
Arm pain, large, red, itchy rash in area of the vaccination. Swollen supraclavicular lymph node on right side.
56 2021-05-26 migraine complete exhaustion; tailbone headache/migraine; body aches; This is a spontaneous report from a non... Read more
complete exhaustion; tailbone headache/migraine; body aches; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown) via an unspecified route of administration in the left arm on 14Mar2021 at 09:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and concomitant medications taken within 2 weeks of vaccination were numerous (Unspecified). Patient was allergic to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 as well. The patient experienced complete exhaustion, body aches, tailbone headache/ migraine. The patient did not receive any treatment for adverse events. The clinical outcome of the events of complete exhaustion, body aches, tailbone headache/migraine was not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
56 2021-05-26 pain in extremity The first day just my arm hurt, but 24 hours later both arms both legs my back and neck hurt so much... Read more
The first day just my arm hurt, but 24 hours later both arms both legs my back and neck hurt so much so that I just had to lay down for the rest of the night
56 2021-05-27 flushing, pain in extremity For 14 days from vaccination in the following order varying from day to day Day 1 and2-sore arm and ... Read more
For 14 days from vaccination in the following order varying from day to day Day 1 and2-sore arm and fatigue Day 3-Fever, chills, joint pain Day 4,5,6-bad headache Day 7-felt better thought clearing out Day 8-terrible sore throat and heavy sweating at night gone by next day Day 9-ok just fatigue Day 10-fatigue and Brain Fog Day 11- Woke up with flush leg rash that was alarming took a picture, it was gone by lunch time Day 12-Brain Fog and Fatigue Day 13-Brain Fog and Fatigue Day 24-Brain Fog and Fatigue
56 2021-05-27 pain in extremity aching began in left arm .Now my left arm is unable to move upwards or backwards without a pain tha... Read more
aching began in left arm .Now my left arm is unable to move upwards or backwards without a pain that makes me vocalizethe pain
56 2021-05-28 night sweats, hot flush headache; intermittent nausea; bloating; sweats/day sweats; chills; hot flashes; leg weakness/ legs ... Read more
headache; intermittent nausea; bloating; sweats/day sweats; chills; hot flashes; leg weakness/ legs "tired" for no reason; feeling depressed; stressful dreams; aches; night sweats; This is a spontaneous report from a contactable consumer (patient) via A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 25Feb2021 13:00 as second dose single for covid-19 immunisation. Medical history included asthma and latex allergy. Concomitant medications included clonazepam, naproxen sodium (ALEVE) and ALBUTEROL (SALBUTAMOL) all are taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient previously took hydrocodone and gluten intolerance and experienced known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient received second dose of the Pfizer vaccine, last Thursday 25Feb2021 around 1pm. Patient reports having a headache on and off ever since. Her worst day was yesterday, today is the first day she actually is going on a walk. She has experienced nausea, bloating, headache on 27Feb2021 17:00 and had to cancel a dental appointment. Patient does not remember exactly when the symptoms started but probably later in the day on Thursday. That night she had sweats, chills, but never had a fever the two times she checked. Patient did feel hot, like hot flashes though. Patient also experienced leg weakness starting on Sunday similar to if you had done strenuous activity the day before. Patient also reports feeling depressed from feeling run down and has had some stressful dreams, aches and night sweats on 27Feb2021 17:00. She declined being transferred to safety because she waited on hold for over 2 hours and then was hung up on. Patient did not receive treatment for the adverse events. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-05-29 tenderness Swelling & tenderness on left collarbone (same side as vaccine). Symptoms of tenderness subsided af... Read more
Swelling & tenderness on left collarbone (same side as vaccine). Symptoms of tenderness subsided after several days. Swelling was diminishing each day. Slight swelling in collarbone still remains approximately 3 weeks later.
56 2021-05-30 weakness Flu like symptoms, headache, body ache, no energy, nauseous. She just started feeling better on 5/... Read more
Flu like symptoms, headache, body ache, no energy, nauseous. She just started feeling better on 5/30/2021.
56 2021-05-30 pain in extremity After having the vaccine late Friday afternoon, had fever, nausea, headache and sore arm on Saturday... Read more
After having the vaccine late Friday afternoon, had fever, nausea, headache and sore arm on Saturday and Sunday, followed by (pseudo-period) blood spot late on Sunday. On Monday, all other side effects had resolved, but began having more (pseudo-period) blood spotting Monday afternoon and evening. My last period was August 2018 (over 2 years, 9 months), so assumed to be in menopause. The bleeding/spotting was definitely a surprise. No treatment (yet), waiting to see if spotting will end within the next day or so.
56 2021-05-30 tingling I noticed a new persistent bitter / metallic taste on my tongue that would not go away; I also have ... Read more
I noticed a new persistent bitter / metallic taste on my tongue that would not go away; I also have experienced, for the first time, nerve tingling in my feet (especially toes, but sometimes heels as well). The symptoms were so strong, I took a covid test to confirm I hadn't somehow come down with covid at the time of vaccination, but my test was negative. I also had a blood sugar test done to confirm it wasn't diabetes, but my fasting blood sugar level was in the normal range (95).
56 2021-05-30 tremor Severe headache, vomiting, diarrhea, body aches, very painful arm and shoulder on injection side, sh... Read more
Severe headache, vomiting, diarrhea, body aches, very painful arm and shoulder on injection side, shaking chills, and fatigue that kept me in bed for 5- 6 eats
56 2021-05-31 weakness, migraine On the first shot - just arm sore. On the second shot - day 2 massive fatigue, no energy, and headac... Read more
On the first shot - just arm sore. On the second shot - day 2 massive fatigue, no energy, and headaches/migraines. Headaches/migraines have persisted daily since receiving shot.
56 2021-05-31 weakness severe headache; Dizziness; weakness; fever; chills; muscle aches; This is a spontaneous report from... Read more
severe headache; Dizziness; weakness; fever; chills; muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202), dose 2 via an unspecified route of administration, administered in arm left on 02Mar2021 18:45 as 2nd dose, single for covid-19 immunisation. Medical history included covid-19, hypothyroidism, hypertension and rheumatoid arthritis. Concomitant medications included levothyroxine sodium (SYNTHROID), acetylsalicylic acid (ASPRIN) and lisinopril (LISINOPRIL). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL9267), via an unspecified route of administration in left arm on 09Feb2021 at 06:45 PM for covid-19 immunisation. On 03Mar2021 06:00 am, patient experience dizziness, weakness, fever, chills, muscle aches and severe headache. Patient was not pregnant. She did not receive any other vaccine in four weeks. The patient did not received treatment for to the events. she had COVID prior vaccination and did not tested for covid post vaccination. The patient did not had any known allergies. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
56 2021-05-31 numbness Milder facial numbness and swelling; Milder facial numbness and swelling; extreme fatigue; This is a... Read more
Milder facial numbness and swelling; Milder facial numbness and swelling; extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL0142, expiry date:not reported), dose 2 via an unspecified route of administration on 04Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EH9899, expiry date: not reported) via an unspecified route of administration on 14DEC2020 as SINGLE DOSE for covid-19 immunisation and experienced flushed swollen face, thick swallowing, mild facial numbness, gastrointestinal pain, nausea, extreme fatigue and mild joint pain. All resolved 2 days post 1st vaccine dose except mild facial numbness. The patient medical history was not reported. Concomitant medications included estrogens conjugated (PREMARIN) .625 mg daily for an unspecified indication for the past 18 years and ongoing, cetirizine hydrochloride (ZYRTEC) 5mg daily for an unspecified indication for more than 10 years and ongoing, levothyroxine sodium (SYNTHROID) 50mcg taken for an unspecified indication from Oct2020 and ongoing, multivitamins and calcium for the past 28 years. On an unspecified date, the patient experienced milder facial numbness and swelling, extreme fatigue. The outcome was events was unknown. No follow-up attempts are possible. No further information is expected.
56 2021-05-31 pain in extremity C/O of pain and stiffness in am after second COVID vaccine.
56 2021-05-31 pain in extremity got covid symptoms one week after her first dose/positive Covid 19 viral test on 22Mar2021; heart ra... Read more
got covid symptoms one week after her first dose/positive Covid 19 viral test on 22Mar2021; heart rate was accelerated at Covid 19 testing site; body ache; a little soreness on her left arm where the injection site is but then soreness in both arms; her right arm is also sore/sore in both arms; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 13Mar2021 at 14:00 (at the age of 56-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she got COVID symptoms one week after her first dose of the Pfizer COVID 19 vaccine and wanted to know if you can get COVID from the vaccine. She wanted to know when does isolation start, from the day of symptoms or diagnosis, if she should get another COVID test done and how long does it take for symptoms to show up once you have been exposed. She got the Pfizer COVID 19 vaccine in the left arm and her right arm is also sore. She wanted to know if that was common. She had her first vaccine on the 13Mar2021 and ended up having Covid 19 virus symptoms on Saturday, 20Mar2021, a week after receiving her Covid 19 vaccine. She had a positive Covid 19 viral test on 22Mar2021. Was asking "Did this have anything to do with the vaccine?" She also had a little soreness on her left arm where the injection site is but then she was sore in both arms. When probing Covid 19 symptoms, she reported on Saturday, 20Mar2021, it was allergy like symptoms - a runny nose, sneezing, congestion, and chills. On Sunday, 21Mar2021, she woke up with more of a chill and a low-grade fever, congestion, body ache and headache. She took acetaminophen, dextromethorphan HBr, phenylephrine HCl (DAYQUIL) every 4 hours at 10:30AM/PM and 2:30AM/PM. She had no appetite, but she drank lots of fluids and ate chicken noodle soup all day. Her temperature at the pharmacy Covid testing site was 99.7F. Her heart rate was accelerated at the Covid 19 testing site, but they weren't concerned with it. Today (unspecified date) she's much better. Therapeutic measures were taken as a result of runny nose, sneezing and congestion. The outcome of the events 'got covid symptoms one week after her first dose/positive Covid 19 viral test on 22Mar2021', 'a little soreness on her left arm where the injection site is but then soreness in both arms', her right arm is also sore and heart rate was accelerated at Covid 19 testing site was unknown, while of the rest was recovering.
56 2021-05-31 pain in extremity bottom of face is still swollen- Feels like there's liquid in it; Had plastic surgery and those scar... Read more
bottom of face is still swollen- Feels like there's liquid in it; Had plastic surgery and those scars are redder today; headache; arm was hurting; swollen face/ swelling in face/ bottom of face is still swollen- Feels like there's liquid in it; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) (at the age of 56-years-old) as 1STDOSE, SINGLE for covid-19 immunisation. Medical history included facial surgery/face lift on Nov2020 and plastic surgery from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient previously took botox on Nov2020. The patient stated that had a face lift in Nov2020 and her face was slow to heal. Patient reported a swollen face after receiving the first dose of the pfizer covid 19 vaccine along with a headache on 30Jan2021. Patient wanted to know was the swollen face because her facial surgery had not healed or was it a reaction to the vaccine. On Sat- 30-40 min later, patient had swelling in face and her arm was hurting yesterday- headache today and bottom of face was still swollen and Feels like there's liquid in it. In Nov caller had plastic surgery and those scars were redder today. Patient wanted to know what she could take for her headache that she thought was related to the pfizer covid 19 vaccine. The patient was enquiring about any information regarding the use of the pfizer-bioNTech covid-19 Vaccine in people who have cosmetic fillers or Botox. Patient stated that she never had anaphylaxis to a vaccine and she had face lift surgery in Nov. Wanted to know if she had an allergic reaction to the vaccine or if it was from the surgery and she was not fully healed. Also stated that her left arm was hurting yesterday but was fine today. Outcome of the events swollen face/swelling in face/ bottom of face is still swollen- Feels like there's liquid in it and headache was not recovered. Outcome of the events arm was hurting, bottom of face is still swollen- Feels like there's liquid in it and had plastic surgery and those scars are redder today was unknown. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
56 2021-06-01 weakness Loss of taste smell hearing and blurred vision about 10% after second injection. Increase in Psorias... Read more
Loss of taste smell hearing and blurred vision about 10% after second injection. Increase in Psoriasis all over my entire body! Gout !Everywhere. I felt horrible for three weeks, no energy unable to eat or sleep. My bones still ache in May 2021. I did not tell anyone for fear they would not get vaccinated.
56 2021-06-01 weakness muscle pain; headaches; swollen glands; the arm where the vaccine was injected could not be lifted a... Read more
muscle pain; headaches; swollen glands; the arm where the vaccine was injected could not be lifted and I still have difficulty lifting it; stiff neck; pain it causes in my back, legs, neck; lack of strength making it difficult for me to sleep; lack of strength making it difficult for me to sleep; The levels my doctor sees for the CReactive protein QT test have doubled.; 4 days with fever; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received BNT162b2 (BNT162b2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) via an unspecified route of administration on 07-APR-2021 11:30 (Lot number: GW0151, Expiry date: Unknown) as 2nd dose, single dose for COVID-19 immunisation. Medical history included Ankylosing Spondylitis, Hypothyroidism, uveitis. The patient previously received first dose of BNT162b2 on 07-MAR-2021 11:45 (Lot number: EN6207, Expiry date was unknown) for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not diagnosed with COVID 19 since the vaccination. Concomitant medications included levothyroxine sodium (SYNTHYROID), folic acid (MANUFACTURER UNKNOWN), methotrexate and adalimumab (HUMIRA) for an unknown indication. On 08-APR-2021 09:30(after 21 hours) experienced fever and on an unknown date muscle pain, headaches, swollen glands, the arm where the vaccine was injected could not be lifted and still have difficulty lifting it, stiff neck, pain it causes in her back, legs, neck, lack of strength making it difficult for me to sleep, lack of strength making it difficult for me to sleep, the levels her doctor seen for the C-Reactive protein QT test have doubled. The patient visited doctor and told him that since she received the vaccine her body was not the same and the pain do not stop. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included C-Reactive protein QT test have doubled on 12Apr2021 was 7500 and on 26Apr2021 was 8510. Therapeutic measures were taken for the events with Medrol-Valium-Mobic. The outcome of the event fever was not recovered and rest of the events was unknown. Follow-up attempts are possible. Further information is expected.
56 2021-06-01 pain in extremity Swelling in the arm pit of her left arm /swelling feels like a sore water pouch; Swelling in the arm... Read more
Swelling in the arm pit of her left arm /swelling feels like a sore water pouch; Swelling in the arm pit of my left arm with small circular bruising; I have swelling in the arm pit of my left arm with small circular bruising. It hurts and aches/swelling felt like a sore water pouch; The ache was also felt through my whole arm; This is a spontaneous report from a contactable consumer (patient) via a sponsored program. This non-pregnant 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications were not reported. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. On 30Apr2021 at 16:30 the patient experienced swelling in the arm pit of her left arm with small circular bruising. She reported it hurt and ached and she had to take ibuprofen to sleep. The ache also was felt through her whole arm. The swelling felt like a sore water pouch. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of swelling in the armpit of her left arm with small circular bruising, it hurt and ached, swelling felt like a sore water pouch, and ache was felt through her whole arm were reported as recovered in 2021. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed; information about lot number cannot be obtained.
56 2021-06-01 tingling, burning sensation This is a spontaneous report from a contactable consumer, the patient. A 56-year-old female patient ... Read more
This is a spontaneous report from a contactable consumer, the patient. A 56-year-old female patient received first dose of BNT162B2 (COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on Monday 24May2021 (age at vaccination: 56 years) at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24May2021 night, the patient started feeling tingling in her left foot. Patient stated that tingling went away for a little bit but came back worse. The patient felt like the toes were on fire. On an unspecified date in May2020, the patient stated that she also has edema in her left leg. Patient was asking whether this was a normal reaction after the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
56 2021-06-01 tenderness This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female pat... Read more
This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received the first dose of BNT162B2(COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported) via an unspecified route of administration on 14May2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14May2021 the patient experienced barely walk (gait disturbance). In May2021, for a good 8-9 days under armpit and breast side of vaccine, swollen (swelling), still feeling pain and tenderness (pain), still feeling pain and tenderness (tenderness), pain under my arm pit (axillary pain), still tired (fatigue), lymph node swollen (lymphadenopathy). The patient was still tired and feel like it's not her, still pain under my arm pit, breast is not swollen, it's a little tender, not like it was last week. Still tired, pain under armpit, not going away, it's tolerable but not comfortable. After this experience, the patient was hesitant to get the second dose. Her appointment was scheduled on 04June2021. The doctor said to wait an extra week. The clinical outcome for I could barely walk was unknown, and the clinical outcome for the events swelling, still feeling pain and tenderness, still pain under my arm pit, still tired, lymph node swollen was not recovered. Information on lot/batch number has been requested.
56 2021-06-01 tremor SHAKING, HEAD ACHES, FATIGUE
56 2021-06-02 burning sensation High blood pressure post vaccine 175/103; blood pressure went through the roof, experiencing waves o... Read more
High blood pressure post vaccine 175/103; blood pressure went through the roof, experiencing waves of up and down of her blood pressure; fatigued; her body started burning; fever; sniffles; flu symptoms like sniffles; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 09:50 (Batch/Lot Number: EW0173; Expiration Date: 31Aug2021) as FIRST DOSE, 0.3 ML SINGLE for covid-19 immunisation. Medical history included subarachnoid haemorrhage from 05Nov2018 to an unknown date, ongoing hypertension (diagnosed 3 or 4 years ago), cerebral haemorrhage from 05Nov2018 to an unknown date. Concomitant medication(s) included azilsartan kamedoxomil (EDARBI, Lot number: 73385, Expiration date: 24Mar2022, NDC number: 60631-040-30) via oral at a dose of 40mg once a day taken for blood pressure abnormal from an unspecified start date to May2021; losartan potassium (Manufacturer: Zydis Pharmas) via oral at a dose of 50mg once a day taken for blood pressure abnormal from an unspecified start date to May2021. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18May2021, caller states after the shot, she was sitting there, getting ready to leave, and her body started burning, she could just feel her blood pressure rising. Caller states she told the lady she's having a reaction, the lady went and got the paramedic, they took her blood pressure, her oxygen level was fine, her heart rate was fine, but her blood pressure jumped up to 175/103 and then after he took it it went right back down. Caller states she doesn't remember the second blood pressure, but it went back down after five minutes. Caller states she's been experiencing waves of her blood pressure going up and down. Caller states she felt okay, her husband came and got her, they ended up going home. The patient states a couple of times she was going to go to the hospital but she thought she didn't want to panic and then she was so fatigued and slept basically for two days and so she wanted it to be reported because when she asked everybody in the very beginning and stated she has blood pressure issues. The patient would like to know if high blood pressure has been reported as a side effect of vaccine or can someone with high blood pressure not get vaccine. Caller would also like to know if there is any contraindication for her to get second dose considering her experencing high blood pressure post vaccine. The patient would like to know how effective a single dose of vaccine. Caller states the higher her blood pressure goes, the more she's susceptible to a brain bleed or a stroke so she's very concerned about taking the second dose. Caller states she has been on blood pressure medicine for the past three years, at least close to three years and her blood pressure has been controlled and spiked in between the times when her doctor changed prescription. Caller states it was a subarachnoid hemorrhage, her frontal lobe was bleeding, but they think it was related more to her blood pressure spiking. The patient states now she's been on medication and she does have a reaction to a lot of the medications after being on it for a while. The patient states she was put on a new medication (not specified) two weeks before the shot. The patient also reported that she had flu symptoms like sniffles, and fever on an unknown date in May2021. The patient states her blood pressure has subsided quite a bit. The outcome of the events flu symptoms like sniffles, and fever was unknown while for other events was resolving. Information on Lot/Batch number was available. Additional information has been requested
56 2021-06-02 numbness she felt dizzy first.; Within 2 minutes heart was racing; felt numb in stomach area; she couldn't sl... Read more
she felt dizzy first.; Within 2 minutes heart was racing; felt numb in stomach area; she couldn't sleep; She felt like contractions in her stomach, like cramping; her whole stomach area getting hard; Her legs/knees were weak.; felt weird; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 31Mar2021 (at the age of 56-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Within 2 minutes of receiving the vaccine, heart was racing, felt numb in stomach area and felt weird. It lasted for two weeks. Primary care physician and cardiologist checked her out. It has been 6 weeks and was advised not to get the second dose. Should she get the dose? She feels like this is a severe reaction. She states she felt dizzy first. When she got home, she thought she was going to die. She laid down and thought she was going to pass out. A few hours later, her heart was racing, and she couldn't sleep. Symptoms alternated between feeling dizzy and her heart racing. She felt like contractions in her stomach, like cramping, and her whole stomach area getting hard. Her legs/knees were weak. She's dealt with this for 4 weeks "really bad". An ultrasound was done, and her heart is fine. The cardiologist said there is nothing to worry about. She feels better now since 6 weeks ago. She went to a cardiologist and her heart is fine, so it's nothing with her heart, but they don't know what it is. The extreme dizziness lasted for 4 weeks and it got a little better. Now she is kind of fine, she is not getting dizzy that bad anymore. Her heart is also fine, it's not that bad anymore. She was asking if she can get the second dose, can it happen again, and should she not take it? Her doctor told her she should wait. She went to her doctor who advised her to not receive the second dose of the vaccine. Should she take the risk of getting the second dose of the vaccine or maybe no? Her doctor doesn't know what to do. Now the first dose was 6 weeks ago, and she doesn't know how long she has to get the second dose. The patient underwent lab tests and procedures which included ultrasound scan: no result on an unspecified date. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
56 2021-06-02 nerve pain Rash on right cheek, itchy, raised, deep red, uncomfortable followed in a few days by nerve pain. Af... Read more
Rash on right cheek, itchy, raised, deep red, uncomfortable followed in a few days by nerve pain. After taking a steroid and anti- viral drug for 1 week, the inflammation decreased and it was no longer uncomfortable. The nerve pain is now gone as of 6/3, and my rash is much small and no longer itches.
56 2021-06-02 numbness and pain in extremities, pain in extremity Neuropathy in hands and feet. Pain shooting down arms and legs
56 2021-06-02 pain in extremity, tenderness This is a spontaneous report received from a contactable consumer (patient) via Medical Information ... Read more
This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A fifty-six-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 05, Apr2021 11:00 (at the age of thirty-six-year-old) as 1st dose, single for COVID-19 Immunization. The patient medical history, family history and concomitant medications were reported as none. The patient did not receive any prior vaccine within four weeks. No other vaccine administered on same date of Pfizer Vaccine. The patient reported that she received first shot of vaccine (yesterday). The patient stated that on 05, Apr2021 her "arm was sore last night and is more tender" this morning, she had been trying not to touch it. The patient started to feel some side effects on 06, Apr2021 (this morning). On 06, Apr2021, she had chills, was not feeling good, had aches and pains, and a headache. The patient stated that, on 06, Apr2021, the chills were gone but she was experiencing the other symptoms. She "feels like she was coming down with the flu". The patient wanted to know if it was okay to be around others (like an infant) and was, she contagious and could she be around other people if she was feeling side effects. She was asking because she kept her granddaughter on Tuesdays. The patient denied any labs, testing, or treatments. The patient had not been to the emergency room or doctor's office in response to the events. The patient enquired that could she take Ibuprofen for her headache. The outcome of the event chills was reported as resolved on 06, Apr2021. The outcome of other events was reported as not resolved. No follow-up attempts are needed. No further information is expected.
56 2021-06-02 pain in extremity 4/14/21 - 1st CoVid shot 11:30 a.m.- arm pain over the next 2 days, few days later noticed a ringing... Read more
4/14/21 - 1st CoVid shot 11:30 a.m.- arm pain over the next 2 days, few days later noticed a ringing in my ears that didn't go away. Not certain exactly when it started as it wasn't very loud and other sounds would mask it. 5/12/21 - 2nd CoVid shot 11:00 a.m.- arm pain, felt like my equilibrium was off that afternoon (a little dizzy, etc), constant ringing in the ears became louder. Next day after the shot had arm pain, fairly bad headache, light nausea, low fever 100.2 in the morning but was gone later in the day. (Felt like a really bad hangover) Took a few days to feel normal, however the constant ringing in the ears has not subsided as of this writing (6/3/21) and can be quite annoying.
56 2021-06-02 tingling, numbness, numbness, tingling Acute anxiety; Adverse effect of COVID-19 vaccine; Heart palpitations; Numbness and tingling of righ... Read more
Acute anxiety; Adverse effect of COVID-19 vaccine; Heart palpitations; Numbness and tingling of right arm and leg
56 2021-06-03 pain in extremity Dizziness; Sore arm; Nauseous; This is a spontaneous report received from a contactable consumer. A ... Read more
Dizziness; Sore arm; Nauseous; This is a spontaneous report received from a contactable consumer. A 56-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP- 7534) via an unspecified route of administration on the left arm on 16Mar2021 at 16:45 (at the age of 56-year-old), as single dose for COVID-19 immunisation. Medical history included inflammatory arthritis, bronchitis and high blood pressure. Concomitant medications included PLAQUENIL, benzonatate (MANUFACTURER UNKNOWN), lizinopril (MANUFACTURER UNKNOWN) and azathioprine (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on the left arm on 16Feb2021 at 16:45 (at the age of 56-year-old), as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced sore arm, dizziness and nauseous on 17Mar2021 at 11:00. The patient did not receive treatment for the reported events. The clinical outcome of painful arm, dizziness and nauseous were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
56 2021-06-05 pain in extremity 1. Swollen lymph nodes--axillary, left upper chest, arm. Also left side of face--cheek, jaw, throa... Read more
1. Swollen lymph nodes--axillary, left upper chest, arm. Also left side of face--cheek, jaw, throat (tonsil). This began within half and hour of vaccination and lasted about 3-4 days. Also happened similarly on second dose (4-16-21, same location). 2. Left upper arm pain. Still ongoing at this time (June 6, 21). Mild to moderate. Occasionally up into neck to behind ear. Difficult to lift left arm from straight out (away from body) further up. Was not affected by second dose.
56 2021-06-06 pain in extremity, tremor The next morning after I woke up with real bad nausea, diarreah, headache, shakes and chills but nev... Read more
The next morning after I woke up with real bad nausea, diarreah, headache, shakes and chills but never developed a fever. And to date I am still experience random symptoms listed associated. I developed pain down both arms, down my neck and chest area also. I have fallen 2 different times but is unsure of why I am now falling
56 2021-06-06 tremor Within 24hrs after the vaccine I developed chills, shaking and a headache. I also developed nausea,... Read more
Within 24hrs after the vaccine I developed chills, shaking and a headache. I also developed nausea, diarreah and just did not feel well for over a week after the vaccine.
56 2021-06-07 weakness The participant did not have symptoms right away but she is diagnosed with the diabetes and still is... Read more
The participant did not have symptoms right away but she is diagnosed with the diabetes and still is sick. She had to take off work for a couple of days. She went to the ER and had tests done and checks up with the doctor regularly. When i went to the ER i was in the worst condition for two hours. The second vaccine made her body weak, according to the patient she thinks all of the medical conditions she has been experiencing is because of the vaccination. I had a lot of trouble sitting and working for a long period of time because my blood pressure kept shooting had to go the doctors a couple of time.
56 2021-06-07 feeling hot, pain in extremity This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (no... Read more
This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:30 (at the age of 56-year-old) at single dose for COVID-19 immunization. No other vaccine received in four weeks. Medical history included hypertension, thyroid disorder, prior to vaccination, patient was diagnosed with COVID-19. No known allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); azilsartan medoxomil, chlortalidone (EDARBYCLOR); nebivolol hydrochloride (BYSTOLIC); cetirizine hydrochloride (ZYRTEC) and antibodies. The patient experienced fever 104.2 fahrenheit for 3 days, sore arm 10 days, hot arm, bones hurt. Loss taste and smell for 10 days (30% better). Pulse ox dropped down to 92 and shortness of breath 3 days. Because she had Covid and was in a long haulers study, patient still had antibodies 11 months post Covid and when she took the 1 vaccine. It was like her body knew this and it rallied. She could not get out of bed for 24 hours. Symptoms began 12 post vaccine on 16Apr2021 at 02:30 AM. She had antibodies drawn 4 weeks after 1 dose and was at the highest limit. The patient also underwent lab tests which included sars-cov-2 test: negative on an unspecified date. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events fever and shortness of breath was recovered on 19Apr2021 for 3 days; sore arm was recovered on 26Apr2021 for 10 days; could not get out of bed was recovered on 17Apr2021 02:30 for 24 hours; outcome of the other events was recovering. This report was reported as non-serious by reporter, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
56 2021-06-07 numbness, mild one side paralysis, pain in extremity It started with feeling run down, are started hurting, started running fever, so then it proceeded t... Read more
It started with feeling run down, are started hurting, started running fever, so then it proceeded to feel nothing on my left side, feeling like with no strength at all. My left side start going down with no feeling. It stated with CIDP. GBS. Then I was admitted into the hospital on Sunday 03/28/2021. I was there for four days. Discharged on 03/31/2021.
56 2021-06-07 migraine chronic migraines began 2 days after. persisted for couple months. vocal cord dysfunction for 3 mo... Read more
chronic migraines began 2 days after. persisted for couple months. vocal cord dysfunction for 3 months and ongoing. Bagan 1 week after second vacccine
56 2021-06-07 pain in extremity Right upper chest pain at end of inspiration and when lying flat - 5/10/2021-5/10/2021. Left calf pa... Read more
Right upper chest pain at end of inspiration and when lying flat - 5/10/2021-5/10/2021. Left calf pain and swelling 5/15/2021 to present. DVT diagnosed 6/1/2021.
56 2021-06-08 bell's palsy, muscle twitching Bell's Palsy. Prednisone, Antiviral medication and artificial tear eye drops. Left Ear Pain on 6/1... Read more
Bell's Palsy. Prednisone, Antiviral medication and artificial tear eye drops. Left Ear Pain on 6/1/2021 in the evening. Twitching on the left side of my mouth. Woke up on 6/2/2021 with the left side of my face very stiff. Went to ER. They said it was the early stages of Bell's Palsy. Followed up with my Primary Care Physician on 6/8/2021 and confirmed Bell's Palsy.
56 2021-06-08 numbness I am having facial numbness in my lower chin/Jaw area that comes and goes. It started again on the a... Read more
I am having facial numbness in my lower chin/Jaw area that comes and goes. It started again on the afternoon of June 2, 2021 and continued into the next day, however the numbness was increasing to different areas on my face. My Dr urged me to go to the ER. They ran several tests and could not come up with a logical solution for the numbness. The symptoms begin on May 17, 2021
56 2021-06-08 migraine Her head is killing her/ Headache; Headache and woke up with migraine; Arm was very sore; This is a ... Read more
Her head is killing her/ Headache; Headache and woke up with migraine; Arm was very sore; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0178), via an unspecified route of administration, administered in left arm on 01Jun2021 17:15 (at the age of 56-year-old) single dose for COVID-19 immunisation at Pharmacy. The patient medical history was none. Concomitant medications were not reported. Prior Vaccinations (within 4 weeks) were none. It was reported that her head was killing her. Asked what can she take for it. Headache at 18:45 and woke up with migraine on 01Jun2021. Arm was very sore on . Got it two days ago and immediately got a headache within an hour and a half or so. That night headache lasted all night and she went to bed Woke up in morning and still had nagging headache. Headache came and went all day. Would get worse and then go away. Last night headache started getting really bad. Went to bed early. Woke up this morning with a migraine. Arm very sore confirmed in the injection arm, upper left arm. Had a little soreness on 01Jun2021. On 02Jun2021 was more sore. 03Jun2021 it's the same. The patient did not visit emergency room or physician office. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
56 2021-06-08 tingling, numbness Felt really bad; Strange tingling in fingertips and hands; Her hand goes numb. It is like a tingling... Read more
Felt really bad; Strange tingling in fingertips and hands; Her hand goes numb. It is like a tingling feeling; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: UNKNOWN), via an unspecified route of administration on 01May2021, as 2nd dose, single dose, for COVID-19 immunization and co-suspect drug included celecoxib (CELEBREX; Capsule, hard; Lot Number: Unknown) for arthritis. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: UNKNOWN), via an unspecified route of administration on 02Apr2021, as single dose for COVID-19 immunization. On 01May2021 at night, after the second shot, the patient experienced a strange tingling in her fingertips and hands, which continued. Patient wondered if it was a side effect and does not know if it improved, persisted or worsened. Patient had no prescribing doctor and she went to pharmacy. Patient felt really bad and had not moved around a lot. It started off with her fingers, and then her hand gone numb. It was like a tingling feeling, as if she laid on it , or slept on it. The clinical outcome of the event strange tingling in fingertips and hands was not resolved. The clinical outcome of all other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-06-10 pain in extremity, numbness, weakness, tingling Runny nose; Runny eyes; Sore arm; Nauseated; I couldn't make a fist with my hand. I couldn't close m... Read more
Runny nose; Runny eyes; Sore arm; Nauseated; I couldn't make a fist with my hand. I couldn't close my hand; Had left side numbness and tingling from my fingertips down to my toes; little tingling and stuff today in my legs and on the bottom of my feet; Had left side numbness and tingling from my fingertips down to my toes; little tingling and stuff today in my legs and on the bottom of my feet; Every day I was experiencing that, like my skin was burning, like I was on fire and my skin was burning all over; My blood pressure went up it was elevated a little bit in the ER on Friday. When I got to Urgent Care, my bottom number was like 102 when I checked it here at home, it was like 105 bottom number; Felt like something popped in my head like air or something like that; This is a spontaneous report from a contactable consumer (reporting on herself). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number: EW0179 and Expiration Date was not reported), via intramuscular route of administration in Arm Left on 27May2021, as 1st dose, single dose for COVID-19 immunization; hydrochlorothiazide (HYDROCHLOROTHIAZIDE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 12.5 mg, 1x/day (12.5 mg, one tablet every day ) for blood pressure measurement. Medical history included hyper-sensitivity from an unknown date and unknown if ongoing , blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for hypersensitivity, start and stop date were not reported. It was reported that patinet had received the Pfizer Vaccine on 27May2021 and had some side effects and her PCP had told her to call you guys to report it and what she had went through and see what advice you give me as far as getting the second dose scheduled on 16Jun2021. she guess you all don't send out like a confirmation or nothing like that she mean to say will something be emailed to me or nothing she won't hear anything else from you guys now that Pfizer will call back with other questions. Patient just saying do she get an email or anything on confirmation that she just called in or anything or she will need anything like that. Patient stated that well, her blood pressure went up and so it was elevated a little bit in the Emergency Room on Friday. But when she got to the Urgent Care, her bottom number was like 102 and when she checked it here at home, it was like 105, the bottom number. So the doctor at Urgent Care, she prescribed me some blood pressure medicine (Hydrochlorothiazide) and so she started on that (Hydrochlorothiazide) on Wednesday and her blood pressure went down but it's still like going up and down, up and down but the most part it is down. Like she said today she had some of the tingling in her leg and then the bot-tom of her feet but not all over like it was before the burning sensation like her skin and stuff. Yeah, also they tried the morning when she was lying in there, when she was, you know, experiencing all of this, all of this on left side, it felt like something popped in her head like air or some-thing like that, she cant, really can't just describe it. she mean it just felt like something popped in the inside of her head, like air or something like air or something like air, its hard to describe. But like she said they did a CT on my brain and all of that stuff and they ruled out stroke and heart at-tack and they ruled out blood clot at the Urgent Care. The outcome of the events was unknown. Follow up needed, further information has been requested.
56 2021-06-10 pain in extremity Head spinning; Body ache/Intense body ache; Aching or having such an intense ache that even her thum... Read more
Head spinning; Body ache/Intense body ache; Aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs; Felt horrible; Aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs; Temperature of 101/Had a temperature of 101; She just feels like the remnants of how you feel after you have a headache ; did not want to move; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 03Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 04Jun2021 the patient experienced head spinning , body ache/intense body ache, aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs, felt horrible, thumbs and ears on the inside were aching, aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs, Temperature of 101/Had a temperature of 101. Also, At 5:00 am this morning, she took 325 mg Aspirin (treatment) and is feeling so much better now. She just feels like the remnants of how you feel after you have a headache ; did not want to move. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The outcome of event was recovering. Follow up attempts are needed. Further information has been requested.
56 2021-06-10 pain in extremity Following my second shot, I have been experiencing pain in my legs. I describe it as feeling like it... Read more
Following my second shot, I have been experiencing pain in my legs. I describe it as feeling like it's in my bones, not necessarily my joints. It requires numerous position adjustments when sitting and lying down. It wakes me up several times in the night. I had none of these issues prior to receiving the vaccine.
56 2021-06-10 tremor Pt began tremoring in the arms, legs and feet and was nauseated. Symptoms worsened about one hour af... Read more
Pt began tremoring in the arms, legs and feet and was nauseated. Symptoms worsened about one hour after administration of vaccine and was seen by Urgent Care. Pt was given Zofran 4mg for the nausea and was advised to go to the emergency room for further follow up. Pt did not go to the ER as advised.
56 2021-06-12 inability to speak Was feeling sick and in bed all day on 6/6, could barely walk or talk on 6/7. Collapsed and stopped ... Read more
Was feeling sick and in bed all day on 6/6, could barely walk or talk on 6/7. Collapsed and stopped breathing/ passed away in the middle of the night late 6/7 or early 6/8.
56 2021-06-12 discomfort, pain in extremity, myelitis transverse, numbness Almost immediate (next day) started having numbness in left fingers 3-5, heavy, glove like feeling i... Read more
Almost immediate (next day) started having numbness in left fingers 3-5, heavy, glove like feeling in left hand, pain down left arm gradually intensifying in frequency and severity over 6-7 weeks. Cervical MRI ordered due to intense, sharp, stabbing left arm pain and numbness down ulnar side of left arm. Admitted to Medical Center on June 11, 2021 due to findings on MRI and worsening of symptoms. Drs. have narrowed down the DX to likely Acute Transverse Myelitis- pending results from a spinal tap done June 12, 2021. Currently still admitted for pain control and IV steroids to control swelling on spinal cord.
56 2021-06-13 weakness, pain in extremity The first shot I did not have any issues. The second shot is my issue, I did not take any pain pills... Read more
The first shot I did not have any issues. The second shot is my issue, I did not take any pain pills or have any other symptoms. For the 2 weeks after my second shot I could not pick up a skillet or open anything. I had no strength in my arm. I am not able to strengthen my arm out without pain. This pain goes from where the shot was given down (inner arm area) pass my elbow. I went back to pharmacy & spoke to the pharmacy & the person that issued me the shot & explained what was going on. He had no knowledge of this side effect. He at that point gave me V-safe to enroll in. It has been 3 weeks since the 2nd dose & I am still not able to fully extend my arm or pick up anything with weight (even my purse). Was a vein damaged or did he not administered it into the muscle, I need answers. Please advise what I need to do to get motion in my arm.
56 2021-06-13 burning sensation all over red raised rash with burning and severe itching , which cause lots of nervousness. I can pr... Read more
all over red raised rash with burning and severe itching , which cause lots of nervousness. I can provide pictures if needed. i was prescribed Prednisone dose pack/ Hydroxyzine/ triamcinolone acetonide cream/ Zyrtec and Benadryle Then the prednisone was upped to 10mg instead of 5 mg/ along with Aveeno bath soaks
56 2021-06-13 tremor Pt received the first dose on 04/30/2021, with no side affects. She received the second dose, 05/21... Read more
Pt received the first dose on 04/30/2021, with no side affects. She received the second dose, 05/21/21 and tolerated it well that day, the following day she had mild chills and shakes. Two days after receiving the vaccine she started having episodes of syncope. When she felt this coming on she would lay down in bed. Had a few episodes where she was nauseas and would vomit. At approximately 2:00pm she blew her nose and when she did she felt a pop under her right eye. Immediately there was swelling under eye, pockets of blood where bruising started. She was taken to Medical Center. After being seen it was determined that she had a Orbital Floor Blowout in her right eye socket. She was questioned as to trauma to the eye, abuse, etc. There was none - she had not fallen or hit anything either. There was no other evidence of an external injury that caused this. No history of injury to this eye or facial trauma at all. She had to see a plastic surgeon the following day and an ophthalmologist. She had to have surgery to place a titanium mesh plate under her eye. Follow Up Appointments are still happening.
56 2021-06-14 weakness, tingling That evening after the 2nd dose vaccine, I heard a very loud, high pitch sound in my ear for about a... Read more
That evening after the 2nd dose vaccine, I heard a very loud, high pitch sound in my ear for about a second and it left me with tinnitus ringing in both ears. This is a constant ringing that does not stop. I did go see a doctor and was prescribed Prednisone, which did not help. I went to an ENT specialist and was prescribed an injectable Prednisone which helped a little bit. The ringing decreased a bit but it got worse again. On 4/8/2021 (a week later) the ringing became extremely loud and my arrythmia started up again. I decided to go to the ER. They did CAT scan and blood work and everything came back normal. I wore a heart monitor for a week which detected fluttering. On 5/12/2021 (a month later) an unusal very itchy rash appeared on my elbow and spread down my left arm and went to my right arm and down both legs. I went to the doctor and was prescribed prednisone. It has kept the rash from spreading but will reappear once I begin to taper prednisone. The doctor believes it is a inflammatory response to the vaccine. Currently ruling out Lyme Disease and Epstein Barre. Recently, I am starting to feel very weak and lacking energy. I am starting to get tingling on my lips and face which comes and goes.
56 2021-06-14 weakness 36 hours after vaccination had Severe tiredness and bad stomach ache fever of 100 and muscle aches ... Read more
36 hours after vaccination had Severe tiredness and bad stomach ache fever of 100 and muscle aches on left side. Continued for 9 days getting less pronounced after day 5 but not abating. Rash on inside of both knees starting on day 8 the same day as muscle aches on left side of chest and back area ,sharp chest pain on left side. felt tired for two more weeks , had trouble completing daily tasks without rest. The tired feeling is better but not a energized as I am normally even now.
56 2021-06-14 paralysis Flacid arm several hours after shot. Had not shown much improvement 60 days after original vaccine s... Read more
Flacid arm several hours after shot. Had not shown much improvement 60 days after original vaccine shot.
56 2021-06-15 discomfort, pain in extremity Day one sore arm. Day two sore arm, extreme tiredness, extreme pain in arm when trying to use it. Da... Read more
Day one sore arm. Day two sore arm, extreme tiredness, extreme pain in arm when trying to use it. Day three tiredness gone. Day four and five arm still has shooting pain when using. Day nine rash breaks out on forearms, both arms. Day ten rash spreads to shoulders and back of neck. Like chicken pox. Starts off small and begins to blister. Extremely itchy and uncomfortable. See Dr and he prescribes natural herbal remedies with water, rash begins to go away after five days of treatment. Pain in upper arm remains through to June 16. Return to Dr and he noticed swelling still in the upper arm muscle. Pain is not as severe but moving the arm certain ways causes a high level of pain.
56 2021-06-15 pain in extremity joint and leg pain, beyond stiffness, elbow and knee pain; joint and leg pain, beyond stiffness, elb... Read more
joint and leg pain, beyond stiffness, elbow and knee pain; joint and leg pain, beyond stiffness, elbow and knee pain; joint and leg pain, beyond stiffness, elbow and knee pain; joint and leg pain, beyond stiffness, elbow and knee pain; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 13Mar2021 16:00 (lot number: ERJ6207) at the age of 56 years old as 2nd dose, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient had no known allergies. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 14Feb2021 19:00 (lot number: EN6201) at the age of 56 years old as 1st dose, single for COVID-19 immunisation. The patient didn't have COVID prior to vaccination. Since the vaccination the patient hadn't been tested for COVID. The patient didn't receive other vaccines in four weeks. On 14Mar2021 14:00 (the following day after the second dose), the patient had continued joint and leg pain, beyond stiffness, elbow and knee pain. No treatment was received by the patient. The patient thought that the symptoms would go away and assumed a few days is no usual but had persisted. The patient then mentioned that at the evening of 14Mar2021, the joint pain became more evident. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
56 2021-06-15 restless legs syndrome, tremor, numbness, tingling Headache photophobia Dizziness nausea joint Pains horizontal double vision Jaw pain orthostatic hy... Read more
Headache photophobia Dizziness nausea joint Pains horizontal double vision Jaw pain orthostatic hypotension confusion feet tingling numbness restless leg Trembling
56 2021-06-16 feeling hot, weakness, migraine, cold sweat Woke up three or four different times with cold sweats- soaking wet and got really cold; Woke up thr... Read more
Woke up three or four different times with cold sweats- soaking wet and got really cold; Woke up three or four different times with cold sweats- soaking wet and got really cold; She couldn't make it to work today; She was soaked and got really cold.; Vomitting; She didn't eat anything all day Saturday and she was only able to eat half a banana on Sunday; Nausea; She was hot; Mild fever; Bad headache; Weakness; She started feeling sick; She hasn't been feeling good; Muscle soreness- hurting all over; Tiredness; Felt like she was getting the covid again; Her body was sore and she was hurting all over; Migraines; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL 1406), via an unspecified route of administration on 26Mar2021 at 11:30AM as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was wondering if what she's experiencing was normal, she hasn't been feeling good since vaccination, she couldn't make it to work today. She felt like getting covid again in December, she didn't know if that was normal or not, she had covid and was in the hospital for it for five and a half days. She clarifies she started feeling sick later that night at about 11:30-12:00 AM, she first woke up with a real bad headache and then she got nauseous and felt sick. she didn't eat anything all day Saturday and she was only able to eat half a banana on Sunday. She confirms she hasn't been nauseas since Sunday morning. On 27Mar2021 experienced vomiting around 1-1:30 AM that stopped about 4-5 am on 27Mar2021. Caller mentions that with the mild fever, this morning she woke up three or four different times with cold sweats. Caller states she doesn't know if it was her fever breaking, but she was soaking wet. Caller clarifies that this was different from night sweats because she was soaked and got really cold. Caller reports she suffers from migraines, she took her migraine medicine, but it didn't help- it didn't make the headache go away. Caller clarifies she is taking Imitrex, but doesn't know the exact dosage. She can take no more than two within a 24 hour period. She doesn't have her pill bottle handy. She explains everything started the symptoms hit her all at the same time that Friday night around 11pm-12am. She was nauseas, headachy, she was hot, running a mild fever, she was weak. It woke her up. Caller states that she feels like she is getting better, most of the muscle soreness is gone. Her body was sore and she was hurting all over, but that's pretty much gone. Caller declines to continue with the report, stating she is really tired and the questions are getting to her and just wearing her out. She had 1st this Friday 26Mar2021 11:30AM, then during that night she experienced the side effects like nausea, headache and fever. Caller is feeling a little better now. Asking if those side effects are normal. Patient wanted to know if the second dose was worse than the first dose for side effects. Patient wanted to know if the People who had covid and received the vaccine then the people who did not have covid and received the vaccine have worse side effects, is that true. As response referred the patient to the doctor. Caller reports her doctor knows about her having covid and being in the hospital. Treatment received included they were giving her antibodies, antivirals, migraine medicine. outcome of Nausea, Vomiting , Muscle soreness was recovered for Headache, Weakness and Tiredness was not recovered for General body pain, Fever was recovering for Migraines was not recovered and for rest of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-06-16 feeling hot, numbness Within five minutes of receiving the vaccination part states that she did not feel face got hot and... Read more
Within five minutes of receiving the vaccination part states that she did not feel face got hot and jaw got hot and hurting, was hlight headed heart, blood pressure went up and heart palpitation, tough swelling and slightly fainted and she waited 45 minutes an tough went down jaw was hearting finger and feet swell and chest was hurting like someone was sitting on her chest, stomach cramps and heart rate was at 100. Called the Dr. told to take Benadryl and Tylenol for pain. Told to take Benadryl and Tylenol before the second dose and was told to have a driver to take her. The second vaccination the jaw was hurting and chest was heavy and glad swelling and left side swelling on the leg and vision was blurry and lodes was swollen and a fainting spell that day. Still have pressure in chest and extremely fatigue and vision is on and off blurry and nausea and diareeha.
56 2021-06-16 numbness, tingling, trigeminal neuralgia Numbness and tingling pain on left side of face (cheek, gums, and jaw) with headache behind left ear... Read more
Numbness and tingling pain on left side of face (cheek, gums, and jaw) with headache behind left ear, on left temple and left parietal region. Headache lasted about 10 days. Numbness persists albeit much milder and intermittently. Was diagnosed as trigeminal neuralgia. Saw PCP and neurologist for this.
56 2021-06-16 numbness Numbness of lower face; swelling of lower face and tongue; swelling of lower face and tongue; sensat... Read more
Numbness of lower face; swelling of lower face and tongue; swelling of lower face and tongue; sensation of lump in throat (throat closing); extreme thirst; low grade fever; This is a spontaneous report from a non-contactable consumer. This 56-year-old female consumer received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN5318) via an unspecified route of administration of single dose (at the age of 54-year-old) on 14Feb2021 at 04:00 PM on right arm for COVID-19 immunization. Patient's allergies included allergies of Soy, corn and honey. The patient's medical history and concomitant medications were not reported. On 14Feb2021, at 04:30 PM patient experienced numbness of lower face, swelling of lower face and tongue, sensation of lump in throat (throat closing), extreme thirst and low grade fever. It was reported that patient required emergency room and patient was monitored for vitals 4.5 hr; and treatment of anti inflammatory and antihistaminic was given. It was reported that patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
56 2021-06-16 migraine, breast pain, pain in extremity The 2nd shot very bad migraine; chills; sore arm; swollen armpit; swollen breast all right side, ver... Read more
The 2nd shot very bad migraine; chills; sore arm; swollen armpit; swollen breast all right side, very painful; swollen breast all right side, very painful; couldn't sleep; constance ache and shooting pain to my nipple on this right side; back swollen; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0170), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 14:00 (at the age of 56-year) as 2nd dose, 0.3 ml single dose for COVID-19 immunization. Medical history was none provided (Patient history: No). Concomitant medication(s) included LISINOPRIL, OMEPRAZOLE; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and LORATADINE taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously received first dose of BNT162B2 (Batch/Lot Number: EW0158) via an unspecified route of administration, administered in Arm left on Apr2021 02:00 PM (at the age of 56-year), 0.3 ml for COVID-19 immunization and experienced migraine, sore arm on the left side the 1st shot. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient stated, both shots very bad migraine a mile sore arm on the left side the 1st shot. The 2nd shot very bad migraine chills and sore arm (29Apr2021 at 12:00) Wednesday the day after. Thursday morning 2nd shot swollen armpit, swollen breast all right side, very painful all day Thursdays all night thursday couldn't sleep (29Apr2021 12:00). Friday the swelling had my right side to the center of my back swollen (2021). Call my doctor went in that friday afternoon she stated it was a reaction to the shot my lymph Nodes. that Saturday and Sunday I couldn't put my bra on due to the swelling. The medication I was giving help some with the swelling and pain. On Monday the next the swelling is not the same but as of today I am still swollen and have a different pain it's more of a constance ache and shooting pain to my nipple on this right side (2021). armpit and breast very swollen. Treatment (Medication) was used for adverse events. Patient visited Doctor or other healthcare professional office/clinic for events. Therapeutic measures were taken as a result of the 2nd shot very bad migraine, chills, sore arm, swollen armpit, swollen breast all right side, very painful , couldn't sleep, constance ache and shooting pain to my nipple on this right side, back swollen. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
56 2021-06-16 migraine, burning sensation After 30 minutes of the shot I experienced burning sensation up to my arms and around my neck. It st... Read more
After 30 minutes of the shot I experienced burning sensation up to my arms and around my neck. It started triggering my migraines very bad.
56 2021-06-16 pain in extremity Diarrhea; Upset stomach; Left arm pain; Red bump at injection site; Headache; This is a spontaneous ... Read more
Diarrhea; Upset stomach; Left arm pain; Red bump at injection site; Headache; This is a spontaneous report from a contactable non-Healthcare professional , the Patient. A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: not known) via unspecified route of administration in the left arm on 14Mar2021 at 08:30 am (at the age of 56-years-old) as a single dose for Covid-19 immunisation. Medical history included suspected to COVID-19 (unspecified date and duration). Concomitant medication was reported as vitamins (manufacturer unknown) which were taken within two weeks of vaccination. Patient showed reaction to prednisone and was allergic to shellfish and nuts. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, in morning patient experienced headache and was not able to get up from the bed. On 17Mar2021 patient experienced diarrhoea and the headache was continuing. Patient also experienced upset stomach and pain in left arm. She also has experienced a bump at injection site. Patient did not receive any therapeutic measures for the events. The clinical outcome of headache was reported to be recovering at the time of report. the clinical outcome of the events diarrhoea, upset stomach, pain in left arm and bump at injection site were unknown. It was unknown if the patient had tested positive for COVID-19 since having the vaccine. No further information is expected. Information about lot number cannot be obtained.
56 2021-06-16 pain in extremity States that when she got her first vaccination - Pfizer 4/15/2021 (left arm) - states that she ... Read more
States that when she got her first vaccination - Pfizer 4/15/2021 (left arm) - states that she just had some soreness at the injection site. Shoulder hurt - felt like she had been working out - took Aleve. She could move it. Put muscle rub on it. Had some tightness in her arm that soon resolved and then it was OK. When she had her second one on 5/6/2021 (left arm), states that it stung a little bit while she was waiting her 15 minutes post injection. The next day, (when she got off at 2 am), her arm hurt. She went to sleep. When she woke, she said that it felt like someone had "cut it open and poured fire in it." States that it is a stinging unrelenting pain. States that she asked at work and was told to give it 72 hours and to alternate heat and ice (which she did). Hurts from top of her shoulder down to her elbow. If she keeps it bent, it does not hurt so badly (rates this pain 7/10) . If she stretches it out, has pain in the same area (rates 10/10). Abduction of the shoulder does not cause pain, only extending the arm and straightening the elbow causes pain. Wearing a Tommy Copper elbow sleeve. She is working using both hands. States that she can't hold a cup in her left hand. States that she also had some N/V for a couple of weeks that she did not think was due to the pain. She treated that successfully with Phenergan. States that the only medicine she takes is for hypertension. She never had any trouble with that before. Advised that this is not something we would expect from a normal vaccine reaction. Advised that we have no one here to see her or to treat her. Advised that she needs to see her PCP with a hands-on visit. She says she has called her PCP and is waiting for them to return her call. She is going to ask to be seen today.
56 2021-06-16 pain in extremity This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:45 (Batch/Lot Number: EN6206) as 1st dose, single dose for COVID-19 immunization.Medical history included insomnia (will take something to help her sleep if she has trouble sleeping, but does not take any regular medications and was a healthy person).The patient concomitant medications were not reported. There was no prior vaccinations within 4 weeks. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 15 Mar 2021 (Batch/Lot Number: EN6206) as 2 nd dose, single dose for covid-19 immunization. The patient reported that she got the 2 shots of the COVID-19 vaccine. On 22Feb2021, after vaccination on same day the patient had severe pain in left arm (started the same day that she received the first dose of the COVID-19 vaccine). The pain has gotten worse, and she would like to know how long she can expect for this continue. The patient was really athletic and does a lot of sports but cannot do many things because of the pain in her left arm. The patient reported that whoever gave her the first dose of the COVID-19 vaccine said that the needle was defective and maybe this was the cause of the pain. Caller reported that she asked whoever gave her the first dose of the COVID-19 vaccine if the shot was still effective and the individual informed her that all the vaccine material was administered to the caller. It was reported that, she knew that when the nurse gave her the shot for the first dose of the COVID-19 vaccine, something happened there and when she took it out, she said the needle was defective to the person standing next to her administering vaccines. It was reported that after a couple weeks of her arm hurting, she talked with her doctor, her doctor said that the arm pain was better than COVID-19 and that it will go away, but the arm pain has continued. Her physician referred her to physical therapy, but she has not started physical therapy yet as she needs to call to make an appointment. Caller reported that she cannot sleep on her left side because her arm was so painful. She does not have any position that she can sleep on her left side and she was a side sleeper and cannot sleep on her left because her arm was too painful. Caller reported that she was vaccinated not to get the disease. The outcome of event severe pain in left arm was not resolved. The outcome of event the needle was defective was unknown.
56 2021-06-16 tingling Anxiety; Energy with 24 hour of extreme tired; Neck and shoulder pain for few hours; Neck and should... Read more
Anxiety; Energy with 24 hour of extreme tired; Neck and shoulder pain for few hours; Neck and shoulder pain for few hours; Left arm tingling around wrist at times; Increased appetite; Weight gain; Two vaccines administered on the same day lot no EW0185, lot WW185; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 18May2021 at 01:00 PM (Batch/Lot Number: EW0185) and another dose via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: WW185) both as a single dose for covid-19 immunization at Pharmacy or Drug Store. Patient relevant medical history included fast heart rate, HBP (high blood pressure), low thyroid, and meneres. The concomitant medications included Atenolol 25mg, fish oil (OMEGA 3), cetirizine hydrochloride (ZYRTEC), colecalciferol, menadione (VITAMIN K+D) all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took cefdinir and had allergy. Patient had known allergies to penicillin and Steroids. On 18May2021, the patient experienced anxiety, energy with 24 hour of extreme tired, neck and shoulder pain for few hours, left arm tingling around wrist at times. Weeks after anxiety and increased appetite and weight gain. Patient was administered with two vaccines on the same day (lot no: EW0185 and WW185). Patient received no treatment for the reported events. The events were considered as non-serious. The outcome of event for neck and shoulder pain for few hours was recovered and for the rest of events was unknown.
56 2021-06-16 tingling Face red; Little tingly in face; Sun burn; This is a spontaneous report from a contactable consumer... Read more
Face red; Little tingly in face; Sun burn; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), via an unspecified route of administration in left arm on 17Mar2021 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not tested for COVID-19. The patient medical history included allergy to dye used for CAT scans. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included TheraCal D 200 supplement for an unknown indication from an unspecified date and unknown if ongoing. On 17Mar2021, after about 15 minutes of vaccination, the patient face became red and felt a little tingly and a little like a sun burn. No itchiness or hives developed anywhere on her body. After about 45 minutes she decided to take one dose of Benadryl. The clinical outcomes of face red, tingly and sunburn was recovered/ resolved. No follow-up attempts are needed. No further information is expected.
56 2021-06-16 tingling EXPERIENCED TINGLING 4-5 MINUTES AFTER RECEIVING VACCINE. TINGLING IN CHEST AND THROAT. BENADRYL 2... Read more
EXPERIENCED TINGLING 4-5 MINUTES AFTER RECEIVING VACCINE. TINGLING IN CHEST AND THROAT. BENADRYL 25MG PO GIVEN.
56 2021-06-17 muscle spasms Headache, fever, heavy chest, racing heart rate, muscle spasms throughout entire body, muscle crampi... Read more
Headache, fever, heavy chest, racing heart rate, muscle spasms throughout entire body, muscle cramping, random uncontrollable burping, chills
56 2021-06-17 night sweats Headache, nausea, and night sweats, starting less than an hour after shot. Lasted off and on for ~2... Read more
Headache, nausea, and night sweats, starting less than an hour after shot. Lasted off and on for ~2 1/2 weeks.
56 2021-06-17 tingling, numbness Throat is closing; Left side of tongue felt swollen and numb; Chills; Feverish; Body Aches; Hands an... Read more
Throat is closing; Left side of tongue felt swollen and numb; Chills; Feverish; Body Aches; Hands and feet numb; Facial Numbness and tingling; Facial Numbness and tingling; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 01Feb2021 11:00 (Batch/Lot Number: EL3249; Expiration Date: 31May2021) as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 07:00 (Batch/Lot Number: EL1284) as SINGLE DOSE for covid-19 immunisation. Medical history included vasculitis from an unknown date and unknown if ongoing Autoimmune called Behcet's which is part of vasculitis autoimmune diseases. Diagnosed 7-8 years ago. There were no concomitant medications. The patient experienced facial numbness and tingling, feverish hands and feet numb, body aches ,chills throat tightness, left side of tongue felt swollen and numb. The outcome of all the events were recovering. When she went to the ER on 02Feb2021, they did a CT scan of her head to make sure it was not a stroke or Bell's Palsy. It was unremarkable and they did a workup of blood and urine, which did not show anything. They came to the conclusion that it was a vaccine reaction. They also did a Chest X-ray and a COVID test and she was negative for both. No follow-up attempts are possible. No further information is expected.
56 2021-06-20 burning sensation I experienced my blood boiling under the skin (left leg), my left collar bone start itching under th... Read more
I experienced my blood boiling under the skin (left leg), my left collar bone start itching under the skin and it also crossed over to the right side.
56 2021-06-21 pain in extremity gained 5 pounds after each dose; really bad edema; foot's all swelled up; enlarged heart; rapid hear... Read more
gained 5 pounds after each dose; really bad edema; foot's all swelled up; enlarged heart; rapid heart beating; feels like she's going to die; soreness of the arm; throwing up; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 06Apr2021 (Batch/Lot Number: ER8735) (age at vaccination 56 year) as single dose for covid-19 immunisation. Medical history included ongoing blood cholesterol increased for over 25 years , stress, anxiety, post-traumatic stress disorder. Concomitant medication(s) included atorvastatin (LIPITOR) for blood cholesterol increased. The first dose of vaccine was administered on 16Mar2021 (lot EP753T) in arm left and patient reported weight gain (5 pounds). After having the second dose of vaccine, on 03May2021, patient experienced enlarged heart, and rapid heart beatings. Patient reported she had to go twice to the hospital, had to call 911, had to get a doppler on her chest, she's been to the cardiologist 5 times just in the last month. Caller states she has to go for a cardiogram on the 16th and may have to have open heart surgery. Patient reported that since having the Covid shot, she's had nothing but trouble. She's not just having soreness of the arm and throwing up. Patient reported that next day, she gained 5 pounds, she retained water or something, she has really bad edema, her foot's all swelled up now. Patient underwent EKGs, Chest X-rays, where it says she has an enlarged heart, rapid heart beating, she had a doppler heart monitor for 3 days. Caller states she has to get a cardiogram, an MRI. Caller states she has heart rhythm problems she feels it in her body. Caller states the doctors didn't say she had heart rhythm problems, but she feels fluttering in her heart. Outcome of events was unknown.
56 2021-06-22 tremor Fever, body ache, headache, back ache, joint pain, chills, shakes, painful lump under arm pit, lump ... Read more
Fever, body ache, headache, back ache, joint pain, chills, shakes, painful lump under arm pit, lump at injection sight, swollen arm, red rash, generalized itching around arm, itching over entire body, red spots spreaded
56 2021-06-24 weakness Approximately 45 minutes after receiving the vaccine in my right arm, I experienced a sharp headache... Read more
Approximately 45 minutes after receiving the vaccine in my right arm, I experienced a sharp headache in my left temple that was brief (under 10 seconds) followed by a drop in energy - similar to going limp but I caught it before it reached that point and "pulled myself together" as I was driving on my way home. Once home, I felt "woozy" but not quite dizzy or weak for about 3 hours. I slept fine and the next day I felt like my body was "bus" and attempted to do a word search puzzle. Normally the words will jump out at me however, at first, it looked like just a square of letters and I had to work at finding the words in the puzzle. On the third day, I felt energized and it wasn't as difficult to do the puzzle however not as easy as it was before the vaccine. Over the course of the last month I felt as if my thinking was disorganized however my jobs do require a fair amount of multitasking so I'm sure that didn't help with my brain processing the vaccine at the same time. My thinking has gradually returned to normal and as of approximately 06/22/2021 is pretty much back to normal and organized and the words in the word search puzzle are again "jumping out at me". The only remaining change since the first dose is a feeling of an energy charge however I have been boosting my vitamins a bit in order to recover from the side effects of the first dose of the vaccine.
56 2021-06-24 numbness, tingling Lt arm became numb & weak w/muscle tightness, legs & feet become numb and face/throat became numb; t... Read more
Lt arm became numb & weak w/muscle tightness, legs & feet become numb and face/throat became numb; tingling and muscle tightness along with bilateral knee pain; muscle tightness/forearm muscle tightness; face/throat became numb along with a puffy eyelid; Lt arm became numb & weak w/muscle tightness; face/throat became numb along with a puffy eyelid; tingling and muscle tightness along with bilateral knee pain; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration, administered in left arm on 06Jan2021 (at the age of 56-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension and high Cholesterol. The patient had no known allergies. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccine in four weeks. Within 5 minutes of received the first vaccine on 06Jan2021, the patient had left arm became numb and weak with muscle tightness; then 1-2 hrs later legs and feet became numb with tingling and muscle tightness along with bilateral knee pain; then 2 hrs later the left side of face/throat became numb along with a puffy eyelid; this lasted 8 days then started resolving; then by the 12th day all symptoms stopped resolving and returned along with right arm numbness/paresthesia and forearm muscle tightness; the numbness and muscle tightening in arms and legs lasted another 2 days; patient still (at the time of report) had some left facial numbness along with paresthesia in both arms elbow to fingers and both legs knees to feet along with occasional knee pain. The patient went to the urgent care on day 2 post vaccine symptoms and day and day 12 post vaccine and was prescribed a muscle relaxant. The patient underwent lab tests and procedures which included nasal swab: negative on 01Feb2021. Therapeutic measures were taken as a result of events and treatment with muscle relaxant. The outcome of the events was resolving. Follow-up attempts are completed. No further information is expected.
56 2021-06-24 pain in extremity Chills; Headache; Fatigue; Sick to her stomach; Felt arm pain; Shortness of breath; Upper respirator... Read more
Chills; Headache; Fatigue; Sick to her stomach; Felt arm pain; Shortness of breath; Upper respiratory infection; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via intramuscular route, administered in left arm, on 08Jan2021 14:00 (Lot number was not reported), at the age of 56 years, as single dose for COVID-19 immunisation. The patient medical history included COVID-19 from 13Dec2020 to unknown date. The concomitant medications were not reported. On 08Jan2021, the patient experienced upper respiratory infection. After 26 hours on 09Jan2021 16:00, the patient experienced chills, headache, fatigue, sick to her stomach and Felt arm pain. On 09Jan2021, patient had shortness of breath. For upper respiratory infection patient was treated with IC-minicyclone 100 mg once daily from 09Jan2021 for 7 days. The outcome of the event upper respiratory infection was recovering. The events chills, headache, fatigue, sick to her stomach was recovered on 10Jan2021 16:00, after 24 hours. The event felt arm pain was recovered after 3 days on 12Jan2021. The outcome of the event shortness of breath was unknown. Information on Lot/Batch number has been requested. Follow-up attempts completed. No further information expected.
56 2021-06-24 tingling, numbness Pt started with headaches sinus pain. Was treated at her family doctor for a sinus infection. These ... Read more
Pt started with headaches sinus pain. Was treated at her family doctor for a sinus infection. These symptoms did not go away and on 5/7/2021 she started getting tingling and numbness in her hands and feet. On 5/8/2021 she was taken to the Hospital and blood work and MRI was taken but did not see anything. She was told to follow up with her family physician on Monday 5/10/2021. She got worse in the evening and had trouble walking. She was taken to another hospital at 4:00 A M on 5/9/2021. On 5/9/2021 the neurologist thought she may have a chemical imbalance. After getting and MRI, blood work and and EMG on 5/10/2021 she was diagnosed with Gillian Barre syndrome and treatments
56 2021-06-26 bell's palsy, facial paralysis Sought treatment on June 5th for drooping right side of mouth and inability to independently operate... Read more
Sought treatment on June 5th for drooping right side of mouth and inability to independently operate right eye (unable to close/blink)
56 2021-06-28 weakness Chest pain, shortness of breath, exercise fatigue, dizziness lasted for 2 months. admitted to Emerg... Read more
Chest pain, shortness of breath, exercise fatigue, dizziness lasted for 2 months. admitted to Emergency Room 5/26/21 riles out Afib and Pulmonary Embolism. Saw Cardiologist at recommendation of ER Dr. on 6/25/21. Further tests scheduled. I am a runner and have been for 30 years - was not able to run more than 1/2 mile and had to keep stopping due to weakness, shortness of breath and chest pain.
56 2021-06-29 facial pain Ok so after the vaccine on 3/25/2021 on 3/26/2021 I got achy and fever. on 3/27 fever and headaches.... Read more
Ok so after the vaccine on 3/25/2021 on 3/26/2021 I got achy and fever. on 3/27 fever and headaches. on 3/28 sore and facial rash and groove in my face like part of my muscle had gotten removed. on 3/29 my temp went back up to 106, dizzy, nauseas, diarrhea, coughing. That is when I called the DR. I just did a telehealth conference with the DR and got no tests. My DR said it was an unusual reaction to the shot.
56 2021-06-29 flushing, burning sensation Rash on left neck, left scalp, left shoulder & left ear; burning sensation on left neck, left scalp,... Read more
Rash on left neck, left scalp, left shoulder & left ear; burning sensation on left neck, left scalp, left shoulder & left ear; Light headache; Flush feeling; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in left arm on 22Mar2021 at 12:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease and the patient was allergic to nuts. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 12:15, the patient experienced rash on left neck, left scalp, left shoulder & left ear and burning sensation on left neck, left scalp, left shoulder & left ear, light headache and flush feeling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures taken for rash on left neck, left scalp, left shoulder & left ear, burning sensation on left neck, left scalp, left shoulder & left ear, light headache and flush feeling included self-treatment with ZYRTEC-D tablet. The clinical outcomes of the events rash, burning sensation, headache and flushing was recovering. Information about lot/batch number cannot be obtained. No further information is expected.
56 2021-06-29 flushing, feeling hot This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant fe... Read more
This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration in the left arm on 17Mar2021 at 12:45 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. The patients medical history included HFpEF heart Failure (heart failure with preserved ejection fraction), pulmonary hypertension, hypothydroidism, protein S deficiency, insulin resistant and high cholesterol. The patient was allergic to demerol, morphine, levaquin, ferahem E (IV iron), humira, penicillin and hydrocodone. The concomitant medications included ELIQUIS, BYSTOLIC, losartan (MANUFACTURER UNKNOWN), nifedipine (MANUFACTURER UNKNOWN) and much more of unspecified drugs which were taken since an unspecified date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 17Mar2021, the patient experienced the first sign of eyes feeling puffy within 21 minutes of the vaccination. On 17Mar202 at 13:15, the patient had very mild sporadic itching that began on the face and neck along with slight flushing/warmth. She also felt like throat was dry throat but wasn't thirsty. All of these symptoms were within an hour and half of the vaccine. The day after vaccine, the patient still had sporadic itching and dry throat. Two days after the vaccination, the patient had a light headache that lasted for 2 days and had a onetime episode of diarrhoea with slight nausea on an unspecified date in Mar2021. Thereafter everything was good. The patient had taken Benadryl as a therapeutic measure. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of eyes feeling puffy, very mild sporadic itching on face and neck, slight flushing/warmth, dry throat, onetime episode of diarrhoea with slight nausea was recovered on an unspecified date in Mar2021 and the clinical outcome of light headache was recovered on 22Mar2021. No follow-up attempts are needed. No further information was expected.
56 2021-06-29 muscle spasms After getting the vaccine I got a fever and was real achy. I had joint pain which I associated with... Read more
After getting the vaccine I got a fever and was real achy. I had joint pain which I associated with my Lyme's disease. I had inflammation in all the joints and pain, like tendonitis. After some weeks I had to take some pain medication, which I had not to take for a couple of years. I assume it was a bug that was going around. I was feeling pretty bad and I went to the ER. They gave me some medicine to settle my stomach, they tested me for Covid-19 because I had been exposed and the test came back negative. As far as I know it was a virus. I still have muscle spasms and inflammation.
56 2021-06-29 pain in extremity Extremely sore arm x 4 days. Exhaustion, muscle aches, lethargy, neck pain, serious headache for 7 d... Read more
Extremely sore arm x 4 days. Exhaustion, muscle aches, lethargy, neck pain, serious headache for 7 days. Continued lethargy and pain and headache for 16 days.
56 2021-06-29 tingling Almost immediate soreness at injection site, as well as tingling in left arm and fingers and palm of... Read more
Almost immediate soreness at injection site, as well as tingling in left arm and fingers and palm of left hand. Pain in shoulder and neck developed after a few days, and is still ongoing. Turning and tilting the head to the left still triggers tingling down the arm into the hand.
56 2021-06-29 unresponsive to stimuli, flushing Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / L... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
56 2021-06-30 facial paralysis Developed Bell's Palsy on April 9,2021. Sought medical help at ER on April 12,2021. Did MRI and echo... Read more
Developed Bell's Palsy on April 9,2021. Sought medical help at ER on April 12,2021. Did MRI and echo due to being stroke like symptoms. Tests were clear. Doctor determined it to be Bell's Palsy. Treated with antivirals and steroids and also given both prescriptions to take at home. Saw PCP within a week to check. As of today, July 1 2021 an some better but still have mouth drooping. Neurologist, that I saw last week seems to think it should get better. Not better yet.
56 2021-06-30 numbness, tingling, pain in extremity, numbness and pain in extremities Sore arm. No other "regular" side effects- felt fine. However, as soon as we were driving home aft... Read more
Sore arm. No other "regular" side effects- felt fine. However, as soon as we were driving home after the second vaccine, I noticed what felt like patches of novocaine wearing off my face. Within two days, my toes, feet, legs, arms, fingers, face and head all had patches of tingliness/pins and needles. I also had numbness most prominently in my toes, and a little in my fingers. Not to the point where I couldn't feel or move my toes- just that I noticed it. I have a history of very mild neuropathy from my pregnancy 15 years ago- on right two toes, right heel and right forefinger. Dr. assumes it was caused by a pinched nerve from extra weight on my back. This numbness from the vaccine was much greater, as were the pins and needles. Just saw a neurologist today who theorizes that the mild neuropathy, coupled with the chemotherapy I received in 2014 got aggravated from my immune system getting flared up from the vaccine. It took 7-8 weeks, but the pins and needles are completely gone, and the numbness is mostly gone (almost back to where it was originally, which is nil). *I was diagnosed with leiomyosarcoma in March 2014, and thankfully sailed through the process with what I thought, no lasting side effects as I am active and healthy. I am cancer free almost 7 years later, but I did take chemo from May-Oct 2014. The neurologist said one can get "sick nerves" from chemotherapy, and while I didn't realize it, maybe I am at 75% with my nerves, and when my immune system was reacting to the vaccine, it couldn't fight it as well as someone who hasn't had chemo, thus the reaction. She asked me to report it. My Internal Medicine doctor sent me to the neurologist about my pins and needles, though just got in today.
56 2021-07-01 weakness uticaria, rash over most of body, continuing today, lethargy, weakness, sore throat, body aches, pai... Read more
uticaria, rash over most of body, continuing today, lethargy, weakness, sore throat, body aches, pain especially in hips, joint pain,
56 2021-07-01 bell's palsy Afflicted with Bell?s Palsy on 06/20/2021. Out of nowhere!
56 2021-07-02 flushing Severe itching; Numbness of lips, tongue and mouth roof; Flushing; tachycardia; anxiety; Possible wo... Read more
Severe itching; Numbness of lips, tongue and mouth roof; Flushing; tachycardia; anxiety; Possible worsening of eyesight on right eye; This is a spontaneous report from a contactable nurse, the patient. A 56-Year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6207) via an unspecified route of administration in left arm on 11Mar2021 at 09:00 hrs (at the age of 56-Year-old) as a single dose for COVID-19 immunisation. Medical history included fillers 3 weeks before vaccine and patient had both. Past drug history included lisinopril from which patient had allergy. Patient received unspecified concomitant medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 09:15 hrs, patient experienced severe itching, numbness of lips, tongue and roof of mouth, flushing, tachycardia, anxiety and possible worsening of eyesight on right eye. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events severe itching, numbness of lips, tongue and roof of mouth, flushing, tachycardia, anxiety and possible worsening of eyesight on right was resolved. No follow-up attempts are possible. No further information is expected.
56 2021-07-02 numbness Vomiting for two days after shot and ondansetron prescribed; swollen glands on left side neck and cl... Read more
Vomiting for two days after shot and ondansetron prescribed; swollen glands on left side neck and clavical area; numbness in hands and fingers; raised blood pressure; 103F fever on day after shot; This is a spontaneous report from a contactable consumer (patient) reported for herself that, A 56-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 03:45 (at the age of 56-years-old) as dose 2, single for covid-19 immunization. Medical history included known allergies to Latex. There were no concomitant medications. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccinations. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. Patient took first dose of bnt162b2 (Batch/Lot Number: EM9809), in Arm left, on 08Feb2021 03:45 for covid-19 immunization. On 02Mar2021, the patient experienced vomiting for two days after shot and ondansetron prescribed, swollen glands on left side neck and clavical area, numbness in hands and fingers, raised blood pressure and 103f fever on day after shot. The events resulted to physician office visit. (serious: no, as reported). The patient underwent lab tests and procedures which included blood pressure measurement: raised and body temperature: 103 fahrenheit on 02Mar2021. Treatment was received for the adverse events as ondansetron. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
56 2021-07-02 migraine debilitating migraine headache; This is a spontaneous report from a contactable consumer, the patien... Read more
debilitating migraine headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and rheumatoid arthritis. Patient received unspecified concomitant medication on an unspecified date and for unspecified indication. Any allergies to medications, food, or other products were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 13:15, the patient experienced debilitating migraine headache. Treatment taken for adverse event was reported as unknown. The clinical outcome of debilitating migraine headache was not recovered. No follow up attempts are possible; Information about lot/batch number has been requested.
56 2021-07-03 nerve pain, pain in extremity Nerve and Muscle pain, fatigue, constantly getting sick. Sever muscle pain in back , calves, feet a... Read more
Nerve and Muscle pain, fatigue, constantly getting sick. Sever muscle pain in back , calves, feet and toes
56 2021-07-04 pain in extremity Soar arm, headache, fatigue, tired.
56 2021-07-05 muscle twitching, numbness Facial numbness, tingling Lip twitching
56 2021-07-05 pain in extremity I'm 56 and very healthy, never sick, never take meds and see a doctor for well-woman only. 3-4 week... Read more
I'm 56 and very healthy, never sick, never take meds and see a doctor for well-woman only. 3-4 weeks after the 2nd dose I started feeling my hands and feet were swollen and very painful to bend. It really hit me on March 28, 2021 I couldn't grab my sheets/blankets when I was cold and My feet hurt so badly I could barely walk. Also, I was very tired, dry eyes, dry mouth, A friend of mine said it sounded like rheumatoid arthritis. I researched it and went to doctor on March 29. She knows I've been healthy and laughed at my self-diagnosis. I have no family history of RA. I told my doctor I thought I got this because of the vaccine. My doctor ordered x-rays and blood work. On March 31st she called me and said my RF and CCP were off the charts, that I have RA and that I need to see a rheumatologist.
56 2021-07-05 pain in extremity Sore arm and redness 2" x 4" for 5 days
56 2021-07-05 throat numbness After receiving pfizer vaccine (about 10 minutes) pt complained of numbness, tingling with fullness ... Read more
After receiving pfizer vaccine (about 10 minutes) pt complained of numbness, tingling with fullness in her throat. She was given epi-0mg in left deltoid area. Paramedics were called in. Pt continued to complain of her tongue tingling and swelling and benadryl 50 mg administered IM. Paramedics arrived and started IV and transported her to ER. Pulse ox was 87% on room air, HR 98 and BP 157/77.
56 2021-07-06 weakness On April 1st we got our 2nd vaccine. On April 8th pt began coughing and feeling weak and dizzy. Not... Read more
On April 1st we got our 2nd vaccine. On April 8th pt began coughing and feeling weak and dizzy. Nothing loose every came out but the coughing has not stopped. The family doctor prescribed a nasal spray nonsteroidal along with a chest Xray which came back clean. With no relief and and shortness of breath I took pt to emergency on May 31st. She had 2 breathing treatments, a CT scan and covid test. Nothing was found and a 3 day Steroid was prescribed. The coughing subsided for those 3 days and returned with tiredness and coughing. Another Doctor's visit with nothing found on June 8th and a multiple steroid prescription. Still no improvement. Pt is feeling weak and still coughing. Please help!!!
56 2021-07-06 facial paralysis, speech disorder Patient began exhibiting signs of stroke within 24 hours of receiving COVID vaccine. Patient was ad... Read more
Patient began exhibiting signs of stroke within 24 hours of receiving COVID vaccine. Patient was administered COVID Pfizer vaccine at around 12 noon on 6/15/21. On 6/16/21 at approximately 10 a.m. patient started having difficulty swallowing. On 6/17/21 Patient's spouse noticed her speech was choppy, she had one sided facial drooping, tongue shift from midline, and difficulty walking (left side affected). Patient was taken to local hospital by her spouse and admitted to Shasta Regional Hospital in Redding , CA. She was diagnosed as having a brain stem stroke. She was hospitalized for 6 days and then transferred to a rehabilitation facility. She was there for 7 days and then went back to a private residence.
56 2021-07-06 feeling cold Pt stated pt got 1st covid vaccine Pfizer 4/29/2021 and pt got hives on left arm, rapid heartbeat af... Read more
Pt stated pt got 1st covid vaccine Pfizer 4/29/2021 and pt got hives on left arm, rapid heartbeat after 6 hours from covid vaccine 4/29/2021. Pt also said tiredness, headache, chills after covid vaccine but pt didn't take any medications. Pt said hives and rapid heartbeat went away in couple of days without taking benadryl nor any medication, treatments. Noted pt is allergic to malaria medication with hallucination, dental anesthesia mediation with hives, bad fish allergy. Pt already made appt with her PCP(outside) and MD recommended pt to get tested for allergy lab with allergy specialist MD. recommended pt to f/u with PCP/Allergy specialist MD prior to 2nd covid vaccine.
56 2021-07-08 cold sweat Patient had syncope. Became dizzy and fell in and out of consciousness. Began perspiring and becam... Read more
Patient had syncope. Became dizzy and fell in and out of consciousness. Began perspiring and became clammy. Breathing was normal. Patient fully recovered after emergency room visit.
56 2021-07-08 pain in extremity She has MS an Auto Immune disorder; Whether she has fatigue or pain; Whether she has fatigue or pain... Read more
She has MS an Auto Immune disorder; Whether she has fatigue or pain; Whether she has fatigue or pain; Received an expired dose/ expired vaccination; Arm sore for five days; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 18Jun2021 10:00 as DOSE 2, SINGLE for covid-19 immunization (56 year when vaccinated). Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0180, expiration date unspecified), via an unspecified route of administration in right arm on 28May2021 10:00 as DOSE 1, SINGLE for covid-19 immunization (56 year when vaccinated). Medical history included multiple sclerosis from an unknown date (Autoimmune disease, as reported), patient also adds it is hard for her to distinguish whether she has fatigue or pain because she has those problems time with MS. There were no concomitant medications. Patient reported that she was originally scheduled to receive the vaccine on 23Mar2021, but she had to delay it because she was in the emergency room with multiple sclerosis at that time. The patient reported that she received a voicemail from the pharmacy, and it was notified to her that she had received expired product during second dose on 18Jun2021 10:00. On an unknown date, the patient developed MS an auto immune disorder (multiple sclerosis) (medically significant). On 18Jun2021, since the vaccination the patients arm sore for five days. On an unknown date the patient started experiencing Fatigue and pain. The outcome of the events was reported as unknown, while for the event sore arm the outcome was reported as recovered. Information on the lot/batch number has been requested.
56 2021-07-08 tingling, pain in extremity Aching in left leg, pricking needles feeling through out body
56 2021-07-09 discomfort I felt tired and run down after shot. two weeks later, on 5/4, a friend died and I could feel mysel... Read more
I felt tired and run down after shot. two weeks later, on 5/4, a friend died and I could feel myself slipping into depression biochemical, but that day I started having all the covid symptoms except for the fever. I CAN NOT BREATHE. It feels like a contact panic attack. Smothering, pressure. Its way worse when I lay down. Insane muscle aches, especially on left side. diarrhea, loss of smell, loss of taste and want for food, insomnia, insane tiredness - up for 1 hour, sleep for 4. some cough - feel need to cough.
56 2021-07-11 burning sensation Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Pat... Read more
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient had a big red circle down her arm, not where we injected her vaccine. It itched and burned. Patient had diarrhea and nausea and also had blisters in her mouth
56 2021-07-11 feeling hot Morning after second dose, experienced severe pain running up the left side of neck, top of head and... Read more
Morning after second dose, experienced severe pain running up the left side of neck, top of head and right side of neck - severe ear aches, both ears - Still happening Following Monday (today) my left arm is swollen, red and radiating heat
56 2021-07-11 nerve pain Nerve pain in both upper arms, heavy pressure in both upper arms, nerve pain in neck and noticable ... Read more
Nerve pain in both upper arms, heavy pressure in both upper arms, nerve pain in neck and noticable weakness in both arms.
56 2021-07-11 pain in extremity, burning sensation 5 days after first injection lymph node in left arm became swollen. days later tenderness and swell... Read more
5 days after first injection lymph node in left arm became swollen. days later tenderness and swelling started traveling down my arm. day after second injection. lymph node became larger, entire arm more painful and swollen, and vein's all the way down to wrist was swollen, painful, and felt like a rubber band being stretched. could not lift up my arm. first was diagnosed with Lymphadenitis and was prescribed amoxicillin. days after kept getting worse so put on Bactrim for 2 weeks and was sent for an MRI of my arm for possible blood clot in arm. No clot detected . Today arm better, still have a small lump under arm and still feed some tightness/pulling/burning in my left arm.
56 2021-07-11 pain in extremity After first dose: swelling of lymph nodes behind left knee; arm soreness; slight headache; slight f... Read more
After first dose: swelling of lymph nodes behind left knee; arm soreness; slight headache; slight fatigue After Second dose: arm soreness; slight headache; sore throat; overall body aches; fatigue; fever; dry eyes; muscle weakness; rash and itching at injection site
56 2021-07-12 weakness Vertigo; dizziness/super dizzy; blurred vision; experienced hair loss; felt fatigue; muscle aching; ... Read more
Vertigo; dizziness/super dizzy; blurred vision; experienced hair loss; felt fatigue; muscle aching; debilitated; sick out of both ends; legs felt like boulders; pressure in the caller's head and eyes; pressure in the caller's head and eyes; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 56-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 22Apr2021 as dose 2, single (at the age of 56-years-old) for COVID-19 immunization. Patient medical history included regular aging stuff like sore shoulders and sore hips, had a bad reaction to anaesthesia and had to have a surgery wide awake because the anesthesia almost killed her, vertigo around 2 years ago. The only vaccine that the patient has ever had was a hep B because she did not like vaccines. She tends to have extreme reactions. Patient has never had any reactions to things like Naprosyn or Motrin which she did not think that she took prior to the vaccine. The concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 01Apr2021 as dose 1, single for COVID-19 immunization. A few days after the 2nd dose of vaccine she felt fatigue with muscle aching. Later she experienced hair loss, blurred vision, and dizziness. Patient experienced super dizzy, blurred vision, vertigo, got debilitated and she lost a bunch of hair (hair loss), sick out of both ends, legs felt like boulders, pressure in the head and eyes. After 1st dose patient experienced really mean and irritable due to sickness. The reported causality between the vaccine and the events was related. Her vertigo became pronounced recently. Patient was not sure if it was from the vaccination but she was suspicious that it was. The reported seriousness for the events super dizzy, blurred vision, vertigo was disabling while of the event hair loss was medically significant. Patient took the first one and then got kind of sick afterwards. After the second dose, the patient got debilitated and she lost a bunch of hair, she felt like she was balding, she typically had super thick hair like you could not find her scalp. The patient had super blurred vision, so blurred that she could not make out the trees three feet in front of her. She was usually a 20/20 vision person. Patient thought the blurred vision went away but all of the sudden she was sitting in on the couch and the dizziness and blurred vision pressured in her head. She got sick out of both ends because she was so dizzy. She had anxiety and she has had a lot of grief and loss around her. It was not far fetched to say that the shock of the vaccine made her hair fall out. She thought the vaccine had stressed her body so bad that her hair fell off. Patient was not going to get the vaccine but she wanted to do her part, she was really scared. After the first dose the patient got sick and really mean and irritable and out of character because she was sick and did not realize it. This happened 2 or 3 days after the first dose which was on 01Apr2021. The patient could not be around people because she was so sick. It went away within a couple of days. When the patient was going for the second shot the caller ended up in bed she could not walk, her legs felt like boulders. The hair loss was an overnight thing. Her hair was brittle and breaking off and all over her pillow and clogging her drains. Patching of bald spots on the top of the her head could be seen, it was like the underlayer of her hair. She thought it was from the stress of the vaccine. She did not even know if it is vertigo, she had vertigo 2 years ago. This vertigo was not triggered by movement. This time the caller could not drive because she could not see. She vomited yesterday, it comes and goes. The caller felt like the dizziness was starting to subside. There was a pressure in her head and eyes. All of the symptoms were swift and sudden. She did not feel she needed to go to an Emergency Room. She was falling apart. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.
56 2021-07-12 fibromyalgia I experienced fever and severe body aches and couldn't stand on my feet which lasted approximately 5... Read more
I experienced fever and severe body aches and couldn't stand on my feet which lasted approximately 55 minutes (considered calling the Paramedics but was able to take some Ibuprofen which helped the pain subside. By the time I notified the Nurse at my doctor's office, the pain had subsided (also indicated that the pain was associated with my Fibromyalgia). I still have muscle pain and my symptoms are worst after receiving the vaccine. I lost my smell and taste along an ammonia or silver smell that has been really bad for a week now. I saw my doctor and some tests were order since there is inflammation around my heart and I don't know if it was caused by the vaccines and am awaiting to see a Cardiologist.
56 2021-07-12 hot flush Fatigue extreme; Joint pain; Hot flashes; Chills; Soreness at shot side; This is a spontaneous repor... Read more
Fatigue extreme; Joint pain; Hot flashes; Chills; Soreness at shot side; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 27Mar2021 at 12:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic to lactose (Food allergy). Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 04Mar2021 at 16:00 (at the age of 56-years-old), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 23:00, the patient experienced fatigue extreme, joint pain, hot flashes, chills and soreness at shot side. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcomes of the events fatigue extreme, joint pain, hot flashes, chills and injection site pain was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-07-12 pain in extremity Pain in arm; Fatigue; Rheumatoid arthritis flare up; Rotator cuff tear; Frozen shoulder exacerbated;... Read more
Pain in arm; Fatigue; Rheumatoid arthritis flare up; Rotator cuff tear; Frozen shoulder exacerbated; Bone spur; Torn muscle; Mobility decreased; Itchy throat; Cough; Seasonal allergy; Postoperative complication; This is a solicited report received from a contactable Physician via a Pfizer marketing program (marketing program name not available). A 56-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8734), via intramuscular on 02Apr2021 as dose 1, single for COVID-19 immunization; adalimumab (HUMIRA; Solution for injection in pre-filled syringe; Batch/Lot number was not reported), subcutaneous from 2020 to an unspecified date in Feb2021 at 40 mg, unknown frequency; then subcutaneous from 28Mar2021 and ongoing at 40 mg, unknown frequency for moderate to severe rheumatoid arthritis. Medical history included right upper arm bone spurs from 2017, right frozen shoulder from 2017, right shoulder torn rotator cuff from 2017, no tobacco user, abstain from alcohol, sulfa drugs and penicillin allergy manifested by hives, cephalosporins allergy manifested by anaphylaxis. Concomitant medications included polycarbophil calcium (FIBERCON) as laxative, paracetamol (TYLENOL) for post-surgery pain, metformin for diabetes; multivitamins [Vitamins NOS] as supplement, naproxen taken for post-surgery pain; Insulin spart (NOVOLOG) for diabetes; Saxagliptin hydrochloride (ONGLYZA) for diabetes; Hydroxychloroquine phosphate (PLAQUENIL) taken for Rheumatoid arthritis and Sjogren's syndrome; Pravastatin taken for high cholesterol; Eletriptan hydrobromide (RELPAX) taken for Migraine; Dulaglutide (TRULICITY) for diabetes and Insulin degludec (TRESIBA) taken for diabetes. The patient previously took Penicillin NOS. The patient underwent lab tests and procedures which included Shoulder Magnetic Resonance Imaging on 19Jan2021 with results of Right shoulder torn rotator cuff, right frozen shoulder exacerbated and right upper arm bone spurs. It was reported that, on 30Mar2021, the patient had rheumatoid arthritis flare up. On an unspecified date in 2021, the patient experienced torn muscle, cough, mobility decreased, itchy throat, seasonal allergy and postoperative complication. On 02Apr2021, the patient experienced pain in arm and fatigue. The events Seasonal allergy and Postoperative complication was assessed as non-serious, whereas rest of the events were assessed as serious (medically significant). The action taken in response to the events with Humira was dose not changed. The outcome of the event rheumatoid arthritis flare-up, mobility decreased, Itchy throat, Cough, Pain in arm was not recovered, outcome of the events Rotator cuff tear, Frozen shoulder exacerbated, Bone spur was recovering, outcome of the event Fatigue was recovered on unspecified date in Apr2021, whereas outcome was unknown for the events torn muscle, seasonal allergy and postoperative complication. Information about exp date has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event pain in arm, fatigue and the suspect drug BNT162B2. Also, there is limited information in the case provided, the causal association between the event Rheumatoid arthritis flare up, Rotator cuff tear, Frozen shoulder exacerbated, Bone spur, Torn muscle, Mobility decreased, Itchy throat, cough, Postoperative complication, Seasonal allergy and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
56 2021-07-12 pain in extremity Had shot on thursday at 6pm had a very sore arm and back all day friday. saturday about 8 am my wri... Read more
Had shot on thursday at 6pm had a very sore arm and back all day friday. saturday about 8 am my wrist started to itch n so did the inside of my elbows. i went to the bathroom n i was completly covered in hives i was beet red n my neck face eyes hands were completly swollen and i threw up. i took two benadryl and it helped alot took three more throughout the day n i was fine. sunday am about 8 again same thing only much more intense itching oh and my heart was beating very rapidly both days took benedryl again and it helped but then went to urgent care because my face was still swollen n wouldnt go down n since it happened twice i was not going to go through that again. ch
56 2021-07-12 tingling Tingling in arm of vaccination. tingling in both legs. Shooting pain and tingling in both feet on Fi... Read more
Tingling in arm of vaccination. tingling in both legs. Shooting pain and tingling in both feet on First day. After that subsiding but still getting randomly.
56 2021-07-13 tingling, numbness, tenderness Reports HA and neck stiffness that initially occurred after receiving 2nd dose x7 days ago. Usually ... Read more
Reports HA and neck stiffness that initially occurred after receiving 2nd dose x7 days ago. Usually felt at night over the right side of her head. Last night spread to left side. Has ear fullness, nec stiffness/tenderness, and intermittent left hand numbness/tingling.
56 2021-07-17 cold sweat, muscle spasms, tingling Diarrhoea; dry heaving/dehydrated; didn't eat all that much; Tingling; Cramps; Gastritis; She wasn't... Read more
Diarrhoea; dry heaving/dehydrated; didn't eat all that much; Tingling; Cramps; Gastritis; She wasn't feeling good.; cold sweats; Severe stomach pain; Nauseous again, like that same feeling; Tired; severe stomach cramps; Diarrhea; very extreme nausea; broke out in cold sweats; fingers felt tingly; tired; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in right upper arm on 22Mar2021 08:45 (Lot Number: ER8727) (at age of 56-year-old) as single dose for covid-19 immunisation. Medical history included Bereavement depression, anxiety, thyroid disorder, colonoscopy, food poisoning (15 or 18 years ago, she went in and had to get hydration because she dehydrated), seasonal allergy. Family Medical History Relevant to AE(s): She said no, she had literally been to hospital 3 times, 2 time were to deliver her babies which were like clockwork, go in have the baby go home, and one time was for food poisoning 15 or 18 years ago, she went in and had to get hydration because she dehydrated. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) taken for thyroid disorder from 13Oct2014 and ongoing; vitamin c [ascorbic acid] taken to avoid the flu and cold and ongoing; biotin (VITAMIN B7) taken to avoid the flu and cold and ongoing; origanum minutiflorum oil (OREGANO OIL) taken to avoid the flu and cold and ongoing; magnesium taken to avoid the flu and cold and ongoing; vitamin b complex (B COMPLEX) taken to avoid the flu and cold and ongoing; vitamin d3 taken to avoid the flu and cold and ongoing; escitalopram oxalate (LEXAPRO) taken for anxiety and bereavement depression from 05Sep2020 and ongoing; trametes versicolor (TURKEY TAIL MUSHROOM) taken to avoid the flu and cold and ongoing; melatonin taken to avoid the flu and cold and ongoing; fish oil/olea europaea (SUPER OMEGA 3) taken to avoid the flu and cold and ongoing. And immune support vitamin and once a day adult women's vitamin for avoid the flu and cold. The patient took vitamins every day for at least 10 years. For indication for Vitamin C, turkey tail, biotin, oregano, immune support vitamin, magnesium, melatonin, B complex , super omega 3, once a day adult women's vitamin, and vitamin D3 she said these were things that had helped her avoid the flu and cold, she had been taking this for about 10 years, she never had the flu or cold, she got seasonal allergies, she thought they work for her, it could be all in her head but she was not going to make any changes. She said the cancer institute recommended turkey tail when he husband was going there. Caller proved names of her supplements via pictures on her phone, she stated that for some supplements she did not have a dosage because she only took a pictures of the front and not the back. The patient experienced severe stomach cramps on 24Mar2021, diarrhea on 24Mar2021 recovered on 25Mar2021, very extreme nausea on 24Mar2021 recovered on 25Mar2021, broke out in cold sweats on 24Mar2021 recovered on 25Mar2021, fingers felt tingly on 24Mar2021, tired on 24Mar2021, diarrhoea on 05Apr2021, dry heaving/dehydrated on 05Apr2021, didn't eat all that much on 05Apr2021, tingling on 05Apr2021, cramps on 05Apr2021, gastritis on 05Apr2021, she wasn't feeling good on 05Apr2021, cold sweats on 05Apr2021, severe stomach pain on 05Apr2021, nauseous again, like that same feeling, tired on 05Apr2021. The clinical course reported as below: She said she had the care here. She said her first shot was 22Mar2021 and 2 days later (on 24Mar2021) she had severe stomach cramps, diarrhea, very extreme nausea, she broke out in cold sweats. She said she attributed it to stress in her life, but no its not, she played it off, she had never felt like that ever, she slept it off, next day she was fine, she was tired but fine. She said the next days there was no nausea and no cramping anymore, it all hit all the sudden, her fingers felt tingly, she had nausea, diarrhea, the nausea was 3 or 4 hours, the diarrhea was 24 hours. She said she was at work, she did not have a fever, she took her temperature when she went home. She said her shot was at 8:45 on the 22Mar2021 and the symptoms started 48 hours later. She said she was tired, she thought that's because there was a lot going on. She felt she was fine. She said the finger tingling kind of went away, she didn't know if it was because she became dehydrated. She remarked she was nervous, she thought to herself was she having a stroke, what happening? She wasn't attributing this to the shot, she wasn't assuming this was from the shot. She said that all ends, so now fast forward to Easter Sunday 04Apr2021 (as reported), that evening she was nauseous again, like that same feeling, she was going to go to bed, she was tired. She said it was at 3 am clarifying that technically this was on 05APR2021 early morning, she had severe stomach pain again, nausea, diarrhea. The Nausea was so bad that she was dry heaving for probably 5 hours but nothing was coming up. She said she didn't eat all that much and maybe it was because it was Easter and there was a lot going on and she wasn't feeling good. She said she had the cold sweats and tingling again, the worst was the cramps. She called her gastroenterologist who did her colonoscopy, she doesn't know if she had diverticulitis or what's going on, he said to go to the ER if she was in that much pain. She said she normally doesn't go to the ER for anything, but she was in that much pain that she went to the hospital, spent the day in the ER, they did tests, blood test, urine, X-Rays, they checked her all out and could not figure out why she was so nauseas, why she was having diarrhea, or why she was in pain, all the test came back fine, there was no infection and no obstruction, maybe it was gastritis. She said they say gastritis, that she had to relieve the stress in her life. She chuckles and wonders what caused all of this. The Nausea the second time was really bad, the first time it lasted couple of hours but this second time it lasted through the night even until she got to the hospital she was even carrying a bag with her because it was gagging her, it was that bad. When queried the outcome of the events the second time around after 05Apr2021, she at first stated that it ended pretty much, but then stated no it didn't end, the stomach cramp continued. They prescribed Zofran for nausea and Bentyl for the diarrhea. She does not know the mg dosage of Zofran and Bentyl. She said she just had to go pick up another thing, her insurance . She looks at her information. She said basically it was the same as before, she just didn't know, they didnt know what was wrong, they didn't even ask if she had the COVID shot, she didn't tell them and they didn't ask. She said for her it was a mental game, so many dates were close to her husband's passing, she wasn't stressing out, her doctor did not think that was what it was, she doesn't feel like it was. She said her doctor said she needs to call, something is going in. She said she took the two medicines for 5 days and they relieved her. Events nauseous again like that same feeling, tired, severe stomach pain, diarrhea, dry heaving/dehydrated, didn't eat all that much, cold sweats, tingling, cramps, gastritis, she wasn't feeling good that started on 05Apr2021 required a visit to emergency room, no physician office visit. She said she had to go to ER, her doctor could not see her that day, he sent her to the ER and that he would see her later if she was admitted. She said she was not admitted, she went in at 9am and was discharged 5pm, she was there for 8 or 9 hours, they gave her IV hydration, did bloodwork, gave her a shot for nausea, dry heaving, to calm her down. She didn't know what the shot was called. She said she was tired of them sticking an IV in her. No Prior Vaccinations (within 4 weeks). The patient declined being sick at the time of vaccination. The patient underwent lab tests and procedures which included blood test with result normal on 05Apr2021 (no high white blood cells no infection and no obstruction), body temperature with result normal on an unknown date (No fever), Urine test with result normal on 05Apr2021 (no infection and no obstruction), x-ray with result normal on 05Apr2021 (no infection and no obstruction). She reported that at the ER on 05Apr2021 she had blood test, urine test, XRays, they checked her all out and could not figure out why she was so nauseas, why she was having diarrhea, all the test came back fine, there was no infection and no obstruction. She says all the tests from the ER came back clean, all blood levels were normal, there were no high white blood cells , she doesn't have them with her, her doctor has that and her doctor said everything came back normal. The event outcome for severe stomach cramps on 24Mar2021, diarrhea on 24Mar2021, very extreme nausea on 24Mar2021, broke out in cold sweats on 24Mar2021, all was recovered on 25Mar2021, fingers felt tingly on 24Mar2021 was recovered on 24Mar2021. For tired on 24Mar2021 was unknown. For diarrhoea on 05Apr2021, dry heaving/dehydrated, didn't eat all that much, tingling, cramps, gastritis, she wasn't feeling good, cold sweats on 05Apr2021, severe stomach pain on 05Apr2021, nauseous again, like that same feeling on 05Apr2021, tired on 05Apr2021, all was recovered in 2021. No follow-up attempts are needed. No further information is expected.
56 2021-07-17 feeling cold This is a spontaneous report from a contactable consumer via Medical Information Team. A 56-year-old... Read more
This is a spontaneous report from a contactable consumer via Medical Information Team. A 56-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in left arm (left upper arm as reported) on 22Mar2021 at 9:30 am (at the age of 56-years-old) as dose 1, single for COVID-19 immunization (vaccine was being given out by military but is not a military facility). The patient medical history included blood pressure. Concomitant medications included Amlodipine for blood pressure which patient had been taking for 7 years. There was no history of all previously immunization and no additional vaccines administered on same date. No family medical history reported. Patient had been feeling dizzy for about a month prior to the first dose. On 23Mar2021 (very next day of vaccination), patient diagnosed with Covid and experienced fever, chills, and feeling cold on an unspecified date in Mar2021. Patient stated that she had a doctor appointment and went to the ear, nose, throat doctor the next day and she was sent for further testing for a COVID-19 test and results came back positive. Patient attributed events to getting the vaccine, but then had tested positive. After testing Positive for COVID-19, the patient had quarantine for a couple of weeks, 10-14 days. The events were Non-serious. Patient was due to have the 2nd vaccine on 12Apr2021 and was asking if she should reschedule as she would be out of quarantine by then. Patient stated that she does not even know if the first one was effective; and wants to know if she needs to start over and was asking if ok to get the second shot or she should wait. Patient stated that she was curious and that this was terrible. Patient asked if first one affected (because tested positive for COVID), was it considered effective or do she have to restart over again. The patient underwent lab tests which included SARS-CoV-2 Test: Positive (COVID-19) on 23Mar2021. Patient stated was given no other treatment tests: exam by ear, nose, throat doctor, nothing significant. The outcome of the events was unknown. It was reported that there was a product complaint with description of complaint: Test result positive for COVID-19 after receiving first dose COVID-19 Vaccine. Description of complaint: Patient again described the entire events in the complaint description. And additional information reported was: Product strength and count size dispensed: unknown; Additional lot numbers: unknown; There was no sample of the product available to be returned, if requested. It was unknown if the packaging was sealed and intact. Follow-up attempts completed. No further information expected.
56 2021-07-17 feeling hot Tired; headache; vertigo; Feeling hot; This is a spontaneous report from a contactable consumer, the... Read more
Tired; headache; vertigo; Feeling hot; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Mar2021 at 11:15 (at the age of 56-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:1470) via an unspecified route of administration in the arm left on 30Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer survivor, hashimoto's hypothyroidism (hashimoto's disease), and asthma. The patient had known allergies to sulfa and gadolinium MRI contrast dye (contrast media dye allergy). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), tamoxifen (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), ibuprofen (ADVIL) and meclozine (MECLIZINE) ; from an unspecified date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021, the patient felt tired and spicy (feeling hot) for a couple of day following injection then one day with headache, followed by vertigo until date of second vaccine. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures taken included self-medication with meclizine hydrochloride. The clinical outcome of the events tired and spicy, headache and vertigo were resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-07-17 flushing Flushing on chest; loose stool; urgency to go tobathroom for two days; This is a spontaneous report ... Read more
Flushing on chest; loose stool; urgency to go tobathroom for two days; This is a spontaneous report from a contactable other healthcare professional, the patient. A 56-years-old, non-pregnant female received first dose of BNT162b2 (PFIZER BIONTECH mRNA COVID-19 vaccine; Lot number: UNKNOWN) via an unspecified route of administration in right arm on 23Mar2021 at 13:30 (at the age of 56-years-old) for COVID-19 immunisation. The patient medical history includes supraventricular tachycardia. Concomitant medications include atenolol (MANUFACTURER UNKNOWN) taken within two weeks of vaccination. The patient has known allergy to aspirin(MANUFACTURER UNKNOWN). Prior to vaccination, patient has not been diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 14:30, the patient experienced flushed chest and loose stools with urgency to go the bathroom for two days. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care The clinical outcome of events flushed chest, loose stools and increased stool urgency was unknown at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained.
56 2021-07-17 pain in extremity, weakness Body aches; Chills; Fever; Nausea; Arm soreness; Fatigue; Weakness; Near-fainting; This is a spontan... Read more
Body aches; Chills; Fever; Nausea; Arm soreness; Fatigue; Weakness; Near-fainting; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via unspecified route of administration in the left arm on 26Mar2021 at 08:45 (age at vaccination 56-year-old) as a single dose for COVID-19 immunisation . Medical history included hypogammaglobulinemia. The patient reported allergies to sulfa, fluoroquinolones, ambien, vicodin, nickel. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19 on unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 26Mar2021 at 08:45, the patient experienced body aches, chills, fever, nausea, arm soreness, fatigue, weakness and near-fainting. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic treatment were taken for the reported events. The clinical outcome of the events of body aches, chills, fever, nausea, arm soreness, fatigue, weakness and near-fainting were resolved with lasting effects. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-07-17 pain in extremity, nerve pain Light headedness and dizzy within 45 minutes of shot. Day 2 nerve pain in left shoulder moving to n... Read more
Light headedness and dizzy within 45 minutes of shot. Day 2 nerve pain in left shoulder moving to neck and right arm. Day 3 severe nerve pain in forearms Day 4 some nerve pain in upper legs and arms. Continuing severe nerve pain in forearms for 4-5 days Day 8 symptoms subsided
56 2021-07-17 pain in extremity I was having some foot pain; amputated to my lower right leg/chopped my leg; blood clot; This is a s... Read more
I was having some foot pain; amputated to my lower right leg/chopped my leg; blood clot; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: ER8730, expiry date: unknown), via an unspecified route of administration, administered in right arm on 12Apr2021 (at the age of 56 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included cervical cancer stage IV from Jun2019 and thyroid disorder unknown if ongoing. The patient had no prior vaccination. Historical vaccine includes first dose of BNT162B2 (lot: EN6208/expiration: unknown) via an unspecified route of administration administered in left arm on an unspecified date for covid-19 immunisation. The concomitant medications included levothyroxine and pembrolizumab (KEYTRUDA) on an unspecified date. April about three weeks after the second shot; i didn't know I thought it was just a foot ache and it didn't get bad until i went into the hospital and they couldn't save my leg and they amputated my right leg. I had blood clot and caused chopped my leg. Consumer stated, I started in April, but i can't remember the exact date, I start having foot pain until 10May2021 and I realize that it was something serious and went to the hospital. I am trying to report that I had Pfizer second vaccine and after that I had a blood clot, and I lost my leg. I am trying to report it to let you guys know because I know you keep record on that, but I had a blood clot that amputated my right leg. The patient was caused/prolonged hospitalization in ICU for the events from May2021 to an unspecified date. The patient had several unspecified lab tests on an unspecified date for which results were unknown. On 10May2021, the patient was treated with blood thinner and a bunch of things for events. Outcome of the events was unknown. Follow-Up (13Jul2021): Follow-up attempts are completed. No further information is expected.
56 2021-07-17 pain in extremity Flu like; achy arm; chills; This is a spontaneous report received from a non-contactable consumer, t... Read more
Flu like; achy arm; chills; This is a spontaneous report received from a non-contactable consumer, the patient. A 56-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208) via an unspecified route of administration on the left arm on 15Mar2021 at 15:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 15Mar2021 at 16:30, couple of hours after vaccination, the patient experienced achy arm and chills. On 16Mar2021 (next morning), the patient experienced achy and flu like symptoms for a total of 1.5 days. The clinical outcome of events pain in arm and chills were unknown; while that of flu like symptoms was recovered on an unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.
56 2021-07-17 pain in extremity Left arm is sore.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-... Read more
Left arm is sore.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 13:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on 24Feb2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 27Feb2021, the patient underwent nasal swab test for SARS-CoV-2 and result was found to be negative. On 25Mar2021 at 16:00, the patient's left arm was sore. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received treatment for the adverse event. The clinical outcome of the event left arm sore was recovering at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-07-17 tingling the back of my neck became occasionally tender/painful to the touch.; I had pins and needles/tinglin... Read more
the back of my neck became occasionally tender/painful to the touch.; I had pins and needles/tingling feeling in my right arm all day Friday./ There was a brief time I thought it was on the right side of my face as well.; This is a spontaneous report from a contactable Consumer (patient). A 56-Year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot number: EN6202) via an unspecified route of administration on 04Mar2021 at 15:00 (Thursday) in the right arm as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history included Penicillin allergy, Cutaneous T Cell Lymphoma, Mal de debarquement Syndrome. The patient's concomitant in two weeks included Zyrtec Allergy. Prior to vaccination, no other vaccine in four weeks and did not had COVID. On 05Mar2021 (Friday), patient had pins and needles/tingling feeling in her right arm all day. There was a brief time she thought it was on the right side of her face as well which went away the next day. On 06Mar2021 (Saturday evening), the back of her neck became occasionally tender/painful to the touch. The patient was unable to tell whether it was swollen. Patient stated that It was feeling better today (Monday). No COVID post vaccination. No treatment received for the events. The outcome of the events was resolving. No follow-up attempts are possible. No further information is expected.
56 2021-07-17 tremor fever; headache; shaking uncontrollably; vomited; pain in my ears; This is a spontaneous report base... Read more
fever; headache; shaking uncontrollably; vomited; pain in my ears; This is a spontaneous report based on the information received by Pharmacy Group. A contactable 56-year-old female consumer (patient) reported that she received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Exp. Date was not reported), via an unspecified route of administration on 13Jun2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration in May2021 at 55 years as Dose 1 single "3 weeks before" for COVID-19 immunization. It was reported that patient received dose 2 of the Pfizer COVID 19 vaccine (site of injection not reported) on Sunday (13Jun2021). The patient had received Dose 1 "3 weeks before" (date not reported). She noted that within several hours "around midnight" on 14Jun2021 she began to experience "a fever" and "a headache" and "shaking uncontrollably" and then 30 minutes later, she "vomited." She also reported "pain in my ears." By 8am on 14Jun2021 these signs/symptoms "subsided." On 15Jun2021, she "kind of felt out it." She did not seek medical attention for any of the effects that she experienced, nor did she contact her healthcare provider about it. The outcome of all events was recovered on an unspecified date in Jun2021. No further information is expected. Information about lot/batch number has been requested.
56 2021-07-17 tremor Feel like Im on fire on the inside - top 1/2 of body; shakes; trouble comprehending paragraphs of te... Read more
Feel like Im on fire on the inside - top 1/2 of body; shakes; trouble comprehending paragraphs of text, trouble driving car; can't concentrate; neck tightness; extreme fatigue; chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8733), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (at the age of 56-year-old) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism, pre-NASH from an unknown date and unknown if ongoing, known allergies to possibly excipients in tablets, latex and more from an unknown date and unknown if ongoing. Concomitant medication(s) included LEVOTHYROXINE; paracetamol (TYLENOL) and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient previously took sudafed [guaifenesin;pseudoephedrine hydrochloride] and nickel and experienced known allergies. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Hospital. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, patient experienced feel like Im on fire on the inside - top 1/2 of body, shakes, chills, extreme fatigue, trouble comprehending paragraphs of text, trouble driving car, can't concentrate, neck tightness. Patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care for the adverse events. Treatment was not received for the adverse events. The events were assessed as serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, caused disabling/incapacitating, did not cause congenital anomaly/birth defect. Patient received second dose of BNT162B2 (lot number: EN6203), administered in Left arm on 19Apr2021 for COVID-19 immunization. The patient underwent lab tests and procedures which included COVID-19: negative. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.
56 2021-07-18 weakness Got my first dose of Pfizer shot on July 1st at 4 p.m. Did not have any reaction on the first 15 mi... Read more
Got my first dose of Pfizer shot on July 1st at 4 p.m. Did not have any reaction on the first 15 minutes of the shot. The next day, July 2, I only had some pain on the area I was injected. However, on July 3, I woke up feeling dizzy, lightheaded, and weakness. At first I did not attribute it to the vaccine. I thought maybe I had low hemoglobin due to my thalassemia. However, my feeling dizzy and lightheaded persisted until July 5th. On July 6th and 7th, I felt the dizziness and lightheadedness subsided. However on the 8th, I felt dizzy and lightheaded again, but this time I experienced brain fog, tinnitus, and was sweating on and off. So, I have been experiencing these symptoms on and off since my first vaccination until now (July 19th). I have not experienced this before. Aside from the medical condition I have mentioned earlier, I do not know of any known underlying health conditions that might trigger these symptoms.
56 2021-07-18 pain in extremity Started noticing arthritic type pain. I have had a meniscus tear ongoing for about three years in m... Read more
Started noticing arthritic type pain. I have had a meniscus tear ongoing for about three years in my right knee, but the knee started hurting a lot worse, achey, not what I'd been feeling, along with my fingers feeling stiff and painful, right shoulder feeling stiff and painful, left knee feeling swollen and achey,
56 2021-07-19 weakness After she got 2 dose, my sister felt like she had COVID again, sore, tired, with temperature. A mont... Read more
After she got 2 dose, my sister felt like she had COVID again, sore, tired, with temperature. A month after the second dose my sister began to feel headaches, stutters when speaking, and lack of energy. They have done all kind of studies on her brain. She was admitted 2 times in the hospital, and they don't find anything abnormal in her brain. She has consulted several neurologist and finally she had a visit with the same doctor who treated her for her cancer, and he thinks everything is related to the COVID vaccine.
56 2021-07-19 pain in extremity Arm soreness. A little nauseated. Loss of appetite. Bitter taste in back of mouth. All foods taste b... Read more
Arm soreness. A little nauseated. Loss of appetite. Bitter taste in back of mouth. All foods taste bitter except sweets.
56 2021-07-19 tenderness Sick with low grade fever and fatigue for 5 days. Large lump under arm receiving the injection which... Read more
Sick with low grade fever and fatigue for 5 days. Large lump under arm receiving the injection which was sore to the touch for about 3 days.
56 2021-07-20 pain in extremity she had soft tissue inflammation in her hands, and joints. this was a few weeks after her second d... Read more
she had soft tissue inflammation in her hands, and joints. this was a few weeks after her second dosing. she complained of muscle pain, upper extremities and her back.
56 2021-07-21 numbness Numbness in lower extremities; Mild body aches; Fever; A large swollen gland located near collar bon... Read more
Numbness in lower extremities; Mild body aches; Fever; A large swollen gland located near collar bone on the left side of body.; Severe headache; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6207) via an unspecified route of administration on 29Mar2021 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN 6203) via an intramuscular route of administration in the left arm on 08Mar2021 at 12:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 05:00, the patient experienced severe headache, fever, mild body aches occurred the day after second vaccination and experienced a large swollen gland located near collar bone on the left side of her body and numbness in lower extremities. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of severe headache, fever, mild body aches, large swollen gland and numbness in lower extremities were not recovered. No follow-up attempts are needed. No further information is expected.
56 2021-07-21 muscle spasms Hand, calves, foot muscle cramping/ severe cramping in chest and back; Nausea; This is a spontaneou... Read more
Hand, calves, foot muscle cramping/ severe cramping in chest and back; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 10:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, kidney infarcts possibly due to aromatose inhibitors and was on blood thinners for the same. Concomitant medications included rivaroxaban (XARELTO) and exemestane (MANUFACTURER UNKNOWN) from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 28Mar2021 the patient experienced hand, calves, foot muscle cramping, severe cramping in chest and back. The patient experienced nausea on 28Mar2021. The patient underwent MRI contrast procedure on an unknown date and had no issues and the result was unknown. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events cramps and nausea were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
56 2021-07-22 numbness and pain in extremities, burning sensation, pain in extremity, tingling This is a spontaneous report from a Pfizer-sponsored program Pfizer RxPathways via a contactable con... Read more
This is a spontaneous report from a Pfizer-sponsored program Pfizer RxPathways via a contactable consumer reported for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) at the age of 56-year-old, as single dose for covid-19 immunization. Medical history included back surgeries, reported she had a history of back surgeries in the past all of which she recovered well from and mild osteoarthritis in the past. The patient's concomitant medications were not reported. The patient received the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date for Covid-19 immunization. On an unspecified date in 2021, she seemed to be having an ongoing reaction to the vaccine resulting in edema, parasthesia and severe joint pain. She was concerned at this point and would like to know how long it can take for the inflammation in her body to subside. She was extremely healthy and fit and have never experienced anything like this. Caller was calling about the covid vaccine. She was having long term reactions. She had seen several doctors, internist, vascular doctor, neurologist, and orthopedist. Her symptoms were severe joint swelling and pain in her knees and thumbs, she had mild osteoarthritis, paresthesia, neuropathy and severe edema. She is an armature athlete. She was scared because her symptoms were not going away. She wanted to do more than reporting bad side effects she would like to speak to someone to see if there are any other people reporting this. Within a couple weeks began to experience the following symptoms: severe inflammation and joint pain, pain in knees and thumbs, mild osteoarthritis in the past that was now severely inflamed, paresthesia described as pins and needles, neuropathy in the hands and feet falling asleep, burning sensation, severe edema, and lymphedema in the legs. Caller reported she was still experiencing the pain right now and it felt like her knee and thumb joints are on fire. Caller had sought medical care from the orthopedic, vascular, and neurologist. They had checked for DVT and autoimmune diseases. Caller was seeking information if other patients have reported these long lasting symptoms. The outcome of the event severe edema, paresthesia described as pins and needles, severe joint pain was not recovered. The outcome of the other events was unknown. Information on the batch/lot number has been requested.
56 2021-07-22 pain in extremity Within a couple of hours of receiving the shot I became very nauseous.; Within a couple of hours of ... Read more
Within a couple of hours of receiving the shot I became very nauseous.; Within a couple of hours of receiving the shot I became very nauseous and vomited several times.; Also felt generally under the weather.; Arm pain came on later in the day.; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 30Mar2021 at 11:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 13:15, the patient experienced nauseous after a couple hours of vaccination and vomited several times, also felt generally under the weather. The patient experienced arm pain later in the day. The adverse events did not result in doctor or other healthcare professional office/clinic or emergency room visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events nauseous after a couple hours of vaccination, vomited several times and the arm pain came on later were resolved on an unknown date. No follow-up attempts are possible. No further information is expected.
56 2021-07-22 pain in extremity Stated that she experienced headaches that were unusual that come and go last few minutes then a sha... Read more
Stated that she experienced headaches that were unusual that come and go last few minutes then a sharp pain and go away; Stated that she had sharp pain on the left side of her chest; Pain radiating up her arms and down her arms; Pain in her shoulder blades; Injection site pain to left arm; Pain radiating down to her fingers/ pain radiating up to her neck/ pain radiating down her back/ pain radiating up her arms and down her arms; Pain radiating up to her neck; Pain radiating down her back; This is a spontaneous report from a Pfizer sponsored program. A 56-year-old female consumer (patient) reported for herself that: A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in the left arm on 24Jun2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that consumer called for reporting adverse reaction after getting first dose of Pfizer COVID vaccine on 24Jun2021. She stated that 24 hours after the first dose that she had pain at the injection site radiating down to her fingers up to her neck and down her back. She experienced headaches that were unusual that come and go last few minutes then a sharp pain and go away. Some days she had headaches some days not a lot. She had sharp pain on the left side of her chest. She spoke to her provider regarding the pain and not related to her heart and other pain she was experiencing. She was told that she was not feeling any pressure and it was not related to her heart. She has headaches every day that come and go. Stated that the headaches were not like normal that it comes for few minutes and then stop. Stated that the pain goes up into her neck and was in her shoulder blades and up her arms and down her arms. She wanted to know if safe to get other one on 15Jul2021. Stated that she went to the doctor "today" about this. She was told to call Pfizer and he would call as well. She wanted to know if this was a normal side effect. Later clarified that it was her left arm for the injection site pain. The outcome of the events was unknown. Information about lot/batch number has been requested.
56 2021-07-22 pain in extremity HSV1 outbreak; left thigh stabbing pain; This is a spontaneous report from a contactable consumer, t... Read more
HSV1 outbreak; left thigh stabbing pain; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 (at the age of 56 years-old) as a single dose for COVID-19 immunisation. Medical history included melanoma in situ, osteomyelitis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included magnesium, zinc, calcium (CALCIUM MAGNESIUM ZINC), collagen (MANUFACTURER UNKNOWN) and vitamin b complex (B COMPLEX); all for unknown indication from an unknown date. On 19Mar2021 at 19:00, the patient experienced left thigh stabbing pain and after 10 days of vaccination, On 25Mar2021, the patient experienced herpes simplex virus type-1 (HSV1) outbreak. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event left thigh stabbing pain and HSV1 was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-07-22 tingling, numbness upon awakening, patient is experiencing tingling down the left arm and numbness of fingers
56 2021-07-23 numbness Chronic numbness in the face and chronic gallbladder infection/inflammation. There was a gallstone b... Read more
Chronic numbness in the face and chronic gallbladder infection/inflammation. There was a gallstone before vaccine but after vaccine the gallbladder became inflamed and numbness on the face was chronic.
56 2021-07-24 pain in extremity I had the injection on 12/27/2020, I had the injection. The next morning, my arm was sore, but I did... Read more
I had the injection on 12/27/2020, I had the injection. The next morning, my arm was sore, but I didn't think anything of it; I thought it was just normal. It lingered for about 2 days. By 12/29, I didn't notice it anymore. On 1/17/2021, I received the second injection. On 1/18, I noticed the same day-after soreness I had had the first time. It lingered for several weeks. I finally talked to my PCP, Dr., about it on 2/26/2021, and she referred me to my orthopedic doctor, whom I saw on 3/18/2021. When I saw Dr., she also X-rayed my left wrist. Orthopedic Dr. didn't think the pain was related to the vaccine. He thought it was just an overuse injury, so he gave me a cortisone injection in the left wrist. The pain in the wrist went away, but Dr. referred me for an EMG test to be done an another doctor's practice. It was discovered during the EMG that I had a significant pinched nerve in my neck. Dr. then referred me for an MRI, which was done clinic. It was discovered through the MRI that I have spinal stenosis, which has resulted in spinal fusion. I was preparing to undergo surgery for spinal stenosis on 7/6/2021, which I did receive. The pain in my shoulder has now returned, and so has the pain in my left wrist. I plan to see Dr. again as soon as possible.
56 2021-07-25 feeling hot That day I had the vaccine where I previously had shingles (3 weeks earlier) got really red and hot ... Read more
That day I had the vaccine where I previously had shingles (3 weeks earlier) got really red and hot and other than that I had no effect. I didn't think much about it because I had no fever. The next morning I woke up itching and didn't know you could break out again with the shingles. Once the rash started appearing and looked just like shingles I called for a doctors appointment. They put me back on Valtrex and I took that round for 7 days and I was still broken out and they called for 3 more days and then it cleared up.
56 2021-07-26 migraine During the night after the first dose of the vaccine I got a fever and headache. I had chest pressur... Read more
During the night after the first dose of the vaccine I got a fever and headache. I had chest pressure I have had congestion and breathing problems for six months since I got the first dose. I am constantly experiencing drainage and congestion which I had never had before. The pain was on the left side under my breast. As the day progressed the chest pain got worse. My fever fluctuated between 101-103 for seven days. I had severe headaches and body aches that whole time. By the tenth day I still had the headache and the fever and body aches had improved. The first three months after the first dose of my vaccine I had more severe Migraines which were so bad that I was nauseated and required a prescription for Imitrex. It helped alleviate the pain. I was medication every other day for five months. My Migraines used to be only once a month and they were controlled Ibuprofen. The pressure on my chest was sharp pains that radiated out from the left side. It has been six months and my Migraines are still persistent three times weekly. The chest pressure has improved but I am still very congested. I got the second dose of the vaccine and there was no change in my symptoms.
56 2021-07-26 muscle spasms June 22nd, in the evening, a very sudden onset of chills - almost like I was having a seizure - it ... Read more
June 22nd, in the evening, a very sudden onset of chills - almost like I was having a seizure - it hit hard and fast. I was asking for blankets. My lips turned blue. My teeth were chattering. My fever got up to 102. I couldn't move and was exhausted. I had muscle cramps in my torso and then got dehydrated. I took a Robaxin - about 30 minutes - after chills fever started. It felt like sepsis. It seemed like a relapse of what I had been through with prior infection except before the vaccine when I had the infection I didn't have the nausea and vomiting. I had rapid heartrate and low blood pressure. I was transported by ambulance to ER - I was nauseous and vomited. I'm still feeling fatigued and - not myself - "feeling a little stupid." Could be from my body having gone all the infections. I am not working - I took until August 10th off. I still get pretty tired easily and by 8 at night - I don't even feel process of getting sleepy - I just get knocked out all of a sudden. I don't take Flexural or Trazodone at night because of just falling asleep so quickly. Note: I may have had the second dose of the Shingrix vaccine a month before this vaccine - and the first dose was a couple years before that. I don't remember the date I had the Shingrix 2nd dose but it was possibly within a month before.
56 2021-07-26 muscle spasms It started in my left thumb, and it felt like it was locking up and we left the restaurant. Then I s... Read more
It started in my left thumb, and it felt like it was locking up and we left the restaurant. Then I started getting cramps in my legs and I had to get out the car and walked around for 10 minutes. About 30 minutes later everything went away. Then in April I went in for a surgery and when I came out, I was ill and had symptoms like body aches, headaches, abdomen pain (due to right adrenal bleed). When they took my bloodwork my Anti-phospholipid syndrome was very, very high and my inflammation level and clotting factors were high as well, highest it's been since 2018. Nobody seemed to know why they were so high. I've had surgery in the past and didn't have issues with clotting. I ended up back in hospital due to adrenal bleed, my blood was very elevated. I was having terrible headaches and really sick for about 10 weeks. Then the leg cramps started 3-4 weeks later where my left foot was going to the side and my toe was sticking up in the air, and I'm still on the medication for the inflammation in the body. I do have Lupus but the leg cramps and stuff like that I've never had ever and the leg cramps, toe sticking up and foot sticking to the side comes and goes. I haven't had it for a week or two as of today.
56 2021-07-26 pain in extremity, muscle spasms I woke up with cramping in my hands, my knuckles in my hands felt stiff achy with joint pain. That l... Read more
I woke up with cramping in my hands, my knuckles in my hands felt stiff achy with joint pain. That lasted about 3 months and then went away. And I haven't had it since.
56 2021-07-27 numbness she sad slight reaction-numbness in arm and slight chest pain, lasted the 10 minutes while she sat t... Read more
she sad slight reaction-numbness in arm and slight chest pain, lasted the 10 minutes while she sat there and then it subsided.; she sad slight reaction-numbness in arm and slight chest pain, lasted the 10 minutes while she sat there and then it subsided.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 02Jun2021 (age at vaccination was 56 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Jun2021, immediately following the first vaccine, the patient experienced slight reaction-numbness in arm and slight chest pain, lasted for 10 minutes while she sat there and then it subsided. She received a response which stated that as noted in the fact sheet for recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Her healthcare provider knows her health situation and had access to information that can better help inform this decision. The adverse event resulted in emergency room visit. She was scheduled for 2nd dose tomorrow. The outcome of event was resolved on 02Jun2021. Information on the lot/batch number has been requested.
56 2021-07-27 muscle spasms, pain in extremity, tingling She hasn't slept hardly at all in about a week; Hurts to walk, stand, lay down, and sit down; Shingl... Read more
She hasn't slept hardly at all in about a week; Hurts to walk, stand, lay down, and sit down; Shingles; Rash is painful to touch, she cannot wear pants, and it feels like pins and needles; Rash on top of right leg- describes as clusters of painful bumps/the rash is painful to touch; Pain in right side of lower back, pelvic area, and top of leg; Pain in right side of lower back, pelvic area, and top of leg; Pain in right side of lower back, pelvic area, and top of leg; Fire pit smell in my nose and in my mouth; It woke me up in the middle of the night; Muscle pain; joint pain; Muscle spasms; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Right on 04Mar2021 (at the age of 56-years-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing osteopenia. Concomitant medications included ergocalciferol (VIT D) and calcium (CALCIUM) taken for osteopenia. On 04Mar2021 the patient experienced muscle pain, joint pain, muscle spasms, fire pit smell in my nose and in my mouth, it woke me up in the middle of the night. On 07Mar2021 the patient experienced pain in right side of lower back, pelvic area, and top of leg. On 12Mar2021 the patient experienced rash on top of right leg- describes as clusters of painful bumps/the rash is painful to touch, rash is painful to touch, she cannot wear pants, and it feels like pins and needles. On 14Mar2021 the patient experienced shingles. On an unknown date the patient experienced she has not slept hardly at all in about a week and hurts to walk, stand, lay down, and sit down. The reporter stated she is not sure if she is having a reaction to the vaccine, she read that it can cause muscle pain and joint pain. Last Thursday morning 04Mar2021 she got the first dose of the Pfizer vaccine and on Sunday she had lower back pain, going to the front of pelvis and it has been getting worse now its going down to leg. She took another medication that can cause the same symptoms and asked can it cause pain 3 days after received the vaccine, is that normal. She did go to the doctor on Tuesday 09Mar2021, for the pain- she did not have the rash then and the doctor thought it was just muscle spasms. She had been on prednisone, Tylenol and muscle spasm medication and Ibuprofen and still having the pain. She called the doctor again today and waiting for his call. On Thursday evening 04Mar2021, she had like a fire pit smell in nose and in my mouth, she could smell other things but that smell was there it woke her up in the middle of the night, it kept her up 2 night in a row. When she woke up Saturday morning 06Mar2021 it was gone. It lasted 36h. She asked if she Can take the vaccine again or should get Modernas vaccine. The patient reported that she developed a rash at the top of her leg. She describes the rash as bumps, it looked like razor burn, then she noticed clumps on Friday, 12Mar2021. She reported over the weekend she was in a lot of pain and there were a couple clusters of the bumps and that she was diagnosed with Shingles on 14Mar2021 at Urgent Care. She stated that the rash is painful to touch, she cannot wear pants, and it feels like pins and needles. Her lower back is very much in a lot of pain, she has not slept hardly at all in about a week. She was prescribed Prednisone on 09Mar2021, 5 pills one each day for 5 days; Ibuprofen; Hydrocodone Acetaminophen (Tylenol with codeine), Topical cream; she was taking Tizanidine for muscle spasms (stopped taking that after they gave her a new prescription on 14Mar2021); Oxycodone for pain today and antibiotic Valacyclovir, the generic for Valtrex for shingles. She reported that she has been out of it, it hurts to walk, stand, lay down, and sit down and she has noft slept all week. Her doctor does not know about the shingles yet and she has to call them. She is scheduled to get the second dose of the Covid vaccine on 25Mar2021 and wanted to know if she needs to get the other dose of the vaccine, will this happen again and how soon. She spoke with a woman when she called and asked about muscle and joint pain following the first dose of the Covid vaccine. The woman provided her with information from the research study: 21% of people reported muscle and joint pain with the first dose. She just inquired about a month ago about shingles vaccine from the doctor, but her doctor said not to get it because if she plans on getting the COVID vaccine in 2 weeks. She asked if should she take her second dose on 25Mar as scheduled or wait some time. Therapeutic measures were taken as a result of muscle pain, joint pain, muscle spasms, pain in right side of lower back, pelvic area, and top of leg, rash on top of right leg- describes as clusters of painful bumps/the rash is painful to touch, shingles and hurts to walk, stand, lay down, and sit down. The outcome of the events shingles, Pain in right side of lower back, pelvic area, and top of leg, Muscle spasms, joint pain, Muscle pain was not resolved, for the events It woke me up in the middle of the night, Fire pit smell in my nose and in my mouth the outcome was resolved on 06Mar2021, for rest of the events the outcome was unknown. No follow-up attempts are possible. No further information is expected.
56 2021-07-27 nerve pain creating shingles/pityriasis type reaction; creating shingles/pityriasis type reaction; nerve ending... Read more
creating shingles/pityriasis type reaction; creating shingles/pityriasis type reaction; nerve ending pain, nerve pain,; nausea; itchy rashes on feet; body aches; chills.; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Apr2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure and herpes. Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN) for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Apr2021 at 07:00, the patient experienced shingles/pityriasis type reaction, nerve ending pain, nerve pain, nausea, itchy rashes on feet. It was reported that nine days of all symptoms. The patient also experienced body aches, chills and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken for the reported events and included treatment with steroid cream for feet, and now acyclovir from the patient. On 02May2021, the patient underwent rapid and full nasal swab COVID-19 test and the result was negative. The clinical outcome of the events creating shingles/pityriasis type reaction, nerve ending pain, nerve pain, nausea, itchy rashes on feet, body aches, chills and fatigue was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-07-27 pain in extremity Inability to raise arm without incredible pain; Bruising and swelling from breast to shoulder on rig... Read more
Inability to raise arm without incredible pain; Bruising and swelling from breast to shoulder on right side; Bruising and swelling from breast to shoulder on right side; Kidneys sore; Sick to stomach; Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 01Apr2021 at 16:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously took flu shot on an unknown date for immunisation and experienced that her body did not tolerate the flu shot. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 04:00, the patient experienced inability to raise arm without incredible pain, bruising and swelling from breast to shoulder on right side, kidneys were sore, sick to stomach and headaches. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events inability to raise arm without incredible pain, bruising and swelling from breast to shoulder on right side, kidneys were sore, sick to stomach and headaches were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
56 2021-07-27 pain in extremity Last normal period was August 2018, so assumed at 56 (nearly 57) I was post-menopausal after having ... Read more
Last normal period was August 2018, so assumed at 56 (nearly 57) I was post-menopausal after having no period for over 2, nearly 3 years.; Discovered (pseudo-period) blood spot.Continued spotting, with heavier spotting Monday afternoon/afternoon evening.; Fever; Nausea; Achiness; Sore arm; This is a spontaneous report from a contactable consumer (patient).A 56-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: EW0172) via an unspecified route of administration in left arm on 28May2021 at 15:45 (at the age of 56-year-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history of the patient included high-blood pressure and multiple sclerosis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications that the patient received within 2 weeks of vaccination included metoprolol succinate (Toprol XL 50 MG), amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos (Juice Plus) and cholecalciferol (D-3 5000 IU), Flax See. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient was allergic to honeydew. Patient previously took Tylenol, penicillin, sulfa-based medications and experienced allergy.On 30May2021, patient experienced fever, nausea, achiness and sore arm on Saturday and Sunday. On 30May2021 (Sunday), in the evening patient discovered (pseudo-period) blood spot, continued spotting, with heavier spotting on Monday afternoon/afternoon evening. Last normal period was Aug2018, so assumed at 56 (nearly 57) patient was post-menopausal after having no period for over 2, nearly 3 years. Patient did not receive any treatment in response to the events. The patient was recovering from all events. Follow-up attempts are completed. No further information is expected.
56 2021-07-27 tingling Fever of 101; Feel crappy; Tired; Seeing spots; Pulse up to 120; B/p was 160; Light headed; Tingly; ... Read more
Fever of 101; Feel crappy; Tired; Seeing spots; Pulse up to 120; B/p was 160; Light headed; Tingly; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and known allergies as blotchy and sensitive skin. Concomitant medications included cetirizine hydrochloride (ZYRTEC) 1 per day, 2000 units of colecalciferol (VITAMIN D3) and 500mg of ascorbic acid (VITAMIN C); all from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, 10minutes after the shot, the patient was driving and started seeing spots, pulse was up to 120, blood pressure was 160 at the fire station. Light headed and tingly. Done in 3 hours and left ED. Next day (25Mar2021), the patient experienced just tired. On day 5, (29Mar2021), the patient experienced fever of 101 and felt crappy. The patient took ibuprofen. The patient would talk to an allergist before taking the second one. Her risk factor was obesity BMI of 40. The events seeing spots, pulse was up to 120, blood pressure was 160, light headed and tingly resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of fever of 101, felt crappy and included treatment with ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of spots, pulse up to 120, blood pressure was 160, light headed, tingly were recovered with sequelae on 24Mar2021. The clinical outcomes of tiredness, fever of 101, felt crappy were recovered with sequelae on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-07-28 burning sensation, tingling, discomfort A few days after I was given the second Pfizer shot, I started experiencing a burning sensation on t... Read more
A few days after I was given the second Pfizer shot, I started experiencing a burning sensation on the upper left side of my back, along with tingling on my left arm, pressure on my left breast and neck.
56 2021-07-28 migraine Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling wi... Read more
Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 09Apr2021 13:00 (at the age of 56-year-old) (Batch/Lot Number: EW0158) as dose 2, single for covid-19 immunisation. Medical history included migraines, Seizure Disorder, and Penicillin Allergy. The patient was not pregnant. Concomitant medications were not reported but patient had other medications in two weeks. The patient had no other vaccine in four weeks. The patient received first dose of bnt162b2 for covid-19 immunisation on 19Mar2021 (at the age of 56-year-old). On 23Apr2021, the patient experienced massive increase in migraines from 6 a year to 3-6 a week and also was dizzy all the time and struggling with vertigo (neither were present before). The events resulted in doctor or other healthcare professional office/clinic visit, and disability or permanent damage. There were no therapy for the events. The patient had no covid prior vaccination and patient was not covid tested post vaccination. Outcome of events was not recovered.
56 2021-07-28 muscle spasms The evening after the first shot, I had intense leg cramps all night, that kept me awake.; This is a... Read more
The evening after the first shot, I had intense leg cramps all night, that kept me awake.; This is a spontaneous report from a contactable 56-year-old female consumer. A 56-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL6198, Expiration date: unknown), via unspecified route, administered in left arm on 09Mar2021 04:00 PM as DOSE 1, SINGLE for COVID-19 immunization. Patient took the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6208, Expiration date: unknown) via unspecified route, administered in left arm on 26Mar2021 04:00 PM as DOSE 2, SINGLE. The patient medical history includes Osteoarthritis, Atrial fibrillation, Enlarged Thyroid, Goiters, and Sulphonamide allergy. Past drug events include CEFZIL induced Drug hypersensitivity and MACROBID induced Drug hypersensitivity. Concomitant medications include bisoprolol fumarate, hydrochlorothiazide (BISPROLOL), Vitamin D, cyanocobalamin (B-12), acetylsalicylic acid (ASPIRIN). Patient was not tested positive prior and post vaccination. No other vaccines were taken in four weeks. On 09Mar2021, 10:00 PM in the evening after the first dose of vaccination, the patient experienced intense leg cramps all night, that kept the patient awake. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and doctor suggested an x-ray, ice and exercise. Lab data includes X-Ray on an unspecified date with normal results. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected
56 2021-07-28 pain in extremity, discomfort I had the usual arm soreness but it was compounded by something much more profound and widespread. F... Read more
I had the usual arm soreness but it was compounded by something much more profound and widespread. From my shoulder down to my elbow I had and still have extreme pain and stiffness accompanied by limited range of motion. This is worse sometimes than others. She it is bad, it interferes with my quality of life (sleep, activity, comfort). I have to be very careful doing things like putting my arm in sleeves and putting weight on it sometimes. I have tried working out, not working out, Tylenol, everything. I?m giving it time, but it has been more than three months.
56 2021-07-28 tremor Rash on neck, chest, underarm and upper back; Violent body shakes; This is a spontaneous report from... Read more
Rash on neck, chest, underarm and upper back; Violent body shakes; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 03Apr2021 at 11:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid (hypothyroidism). The patient had no known allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 13Mar2021 at 11:15 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 04Apr2021 at 01:30, the patient experienced violent body shakes (not chills). On 05Apr2021 at 11:15, 48 hours after the vaccination, the patient experienced a rash on the neck, chest, underarm and upper back. The patient reported that the rash looked like a bad sunburn. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events rash on neck, chest, underarm and upper back and violent body shakes was resolved on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.
56 2021-07-29 pain in extremity a mild headache; but she is still dragging on energy and is still fatigued.; dragging on her feet; m... Read more
a mild headache; but she is still dragging on energy and is still fatigued.; dragging on her feet; mild pain in the left arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 at 14:00 (at the age of 56-year-old) as a single for COVID-19 immunisation at pharmacy. The patients Medical history and concomitant medications were not reported . No investigation assessment. No family medical history relevant to adverse was reported. Vaccine Administered at Facility was reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No vaccines administered on same date of the Pfizer suspect. Report not related to a study or programme. Reporter gave consent to contact. No previous immunization with the Pfizer vaccine considered as suspect. on 30Apr2021, the patient experienced mild pain in the left arm, and on 01May2021, she experienced a mild headache, but she was still dragging on energy and was still fatigued, dragging on her feet. It was reported that, a 56-year-old female patient who received her 1st dose of the Pfizer COVID Vaccine on 30Apr2021. She experienced mild pain in the left arm, a mild headache, and tiredness. It was going to be 2 weeks tomorrow, but she was still dragging on energy and is still fatigued. She mentioned that she can do her daily routine and was getting the proper amount of sleep but every morning she just feels fatigued and dragging on her feet. She texts with her doctor and they mentioned that they have also observed this in patients lasting for about 4 to 6 weeks. She was due for her 2nd dose on 21May2021. She was asking if it was normal for her to have the fatigue for this long. Patient asked, was it normal for her to still have fatigue 2 weeks later. Patient stated it kind of went away that following Monday and then it came back, and she has been dragging this week more noticeably, it will be 2 weeks tomorrow. No treatment was received for the events. No adverse event required a visit to emergency room or physician office. No relevant tests were performed. No product quality complaint was reported. The outcome of event mild pain in the left arm was resolved on 01May2021 and mild headache was resolved on 03May2021,outcome of the events but she was still dragging on energy and was still fatigued and dragging on her feet was reported as Not resolved . No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
56 2021-07-29 pain in extremity Exhausted; Sore arm; She couldn't sleep on it./couldn't sleep on her arm; She got a very bad rash; P... Read more
Exhausted; Sore arm; She couldn't sleep on it./couldn't sleep on her arm; She got a very bad rash; Persistent cough; Cough with post nasal drip; The cough starts and then turns into a deep cough and then it sounds like an asthma attack, like wheezing really bad; She can't breath; This is a spontaneous report from a contactable consumer or other non-health care professional. A 56-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in Left Arm on 26Mar2021 13:30 as DOSE 1, SINGLE for Covid-19 immunisation. The patient medical history included food allergy, drug hypersensitivity She's also allergic to Sulfa. The patient concomitant medications included triamcinolone (TRIAMCINOLONE) and ongoing; estradiol (ESTROGEN). No other history. Prior Vaccinations (within 4 weeks) has not been received. On an unspecified date in 2021, the patient had experienced persistent cough, cough with post nasal drip, the cough starts and then turns into a deep cough and then it sounds like an asthma attack, like wheezing really bad, on 26Mar2021 sore arm, on 28Mar2021 exhausted, she can't breath on 2021, she couldn't sleep on it./couldn't sleep on her arm on 26Mar2021, she got a very bad rash. The patient underwent lab tests which included antibody test: unknown on 02Apr2021 She had an antibody test but did not share the results, investigation: unknown, She had a breathing test and all tests were fine and show there is no reason for this cough, pulmonary function test abnormal: fine, pulmonology, and ear nose and throat and all tests were fine, sars-cov-2 test: negative on 02Apr2021 She also was tested for the Covid-19 virus twice with rapid and PCR and they were negative, sars-cov-2 test: negative on 19Apr2021 She also was tested for the Covid-19 virus twice with rapid and PCR and they were negative, sars-cov-2 test: negative on 02Apr2021. She also was tested for the Covid-19 virus twice with rapid and PCR and they were negative, sars-cov-2 test: negative on 19Apr2021 She also was tested for the Covid-19 virus twice with rapid and PCR and they were negative. The outcome of events persistent cough, cough with post nasal drip, the cough starts and then turns into a deep cough and then it sounds like an asthma attack, like wheezing really bad was not recovered and outcome of event sore arm, she couldn't sleep on it./couldn't sleep on her arm was recovered on 29Mar2021. Outcome of events exhausted, she can't breath, she got a very bad rash was unknown. She stated her doctors did not recommend she get the second dose. She went to get the vaccine against the doctors advice and they would not give it to her because of the way she was coughing. The vaccination provider said there was no way she would give it to her because she did not know what type of reaction she would have after hearing her coughing. She called VAERS and they told her that other people were reporting this with the vaccine but she was not sure which manufacturer. She is looking for data on people that have experienced this cough and whether they went for the second shot or if they waited for their symptoms to go away. She is trying to make an educated decision and wanted data on the people getting the second dose after having this symptoms. The doctor said she is 80% covered with one dose. The caller asked how long the first dose is effective for and how much does it protect you? And caller asked if you receive the vaccine do you get antibodies? Would you test positive on an antibody test? She wants to get an antibody test done to make sure she is protected. Response: Read from attached documents "If your body develops an immune response, which is the goal of vaccination, there is a possibility you may test positive on some antibody tests after receiving the Pfizer-BioNTech COVID-19 Vaccine." (CONS-can the vaccine cause a false positive COVID-19 test (v2.0). Additionally, "COVID-19 vaccination will help protect you by creating an antibody (immune system) response without having to experience sickness. CDC states that antibody testing is not recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. In addition, antibody tests currently authorized under an Emergency Use Authorization (EUA) are not authorized for the assessment of immune response in vaccinated people." (CONS - Why did I get a negative antibody test after being fully vaccinated US. The caller stated, so "we don't have answers to anything, we do not recommend this and no one can give me answers. You are Pfizer who makes the vaccine so how can you refer me to the CDC (she was referred to the CDC regarding further questions about the CDC's recommendations) no one has answers." She reports the following in a historical context, when she takes Codeine she runs around like she's on speed, things act really weird to her, she's not normal. She also never gets the flu vaccine. NDC/Lot/Expiry for Codeine not known. She lives with her 80 year old mother and her mother is terrified of getting the Covid 19 vaccine because she thinks she might have an allergic reaction to the Covid 19 vaccine and die and there's nothing that will convince her mother otherwise. The caller thought, she'll get the Covid 19 vaccine to prove to her mother that it's fine. Since the caller has received the Covid 19 vaccine she's had a cough that is relentless. She coughed only three times yesterday, 29Apr2021 and only one time today so far. The cough starts and then turns into a deep cough and then it sounds like an asthma attack, like wheezing really bad. She went to the doctor and he told her it sounded like she had the Covid 19 virus. She hasn't gone anywhere so if she got the Covid 19 virus, she got it from her doctor's office. She had both the rapid and the PCR Covid 19 virus test. Her tests were negative. Two weeks later she had another set of Covid 19 virus tests, the rapid and the PCR as well as the Covid 19 antibody test. Her rapid and PCR tests were negative. She then went to an Ear, Nose, and Throat doctor because it's two weeks later and she's freaking out because she's supposed to get the second Covid 19 vaccine and what is she supposed to do. When it came to her asking for advice on whether to receive the second Covid 19 vaccine, no one was giving her an answer. Her primary care doctor was telling her she can't breath, but the Ear, Nose, and Throat doctor told her she was fine and she was also being seen by a pulmonologist. The pulmonologist scheduled her for a breathing test and that test was perfect. The pulmonologist told her she had above average lung capacity. Her regular doctor told her to go with her gut on whether she should get the second vaccine or not. The pulmonologist said with her reaction he would be on the cautious side because he's conservative. Her pulmonologist would not get the second Covid 19 vaccine because she doesn't know what the second vaccine is going to do to her, what kind of reaction she'll have. She also saw an allergist and the allergist wanted to put her on an Albuterol inhaler but it didn't help and only gave her a headache. NDC/Lot/Expiry for Albuterol not known. The one thing that did help was to take a Vick's container and put it under nose and that helps. If she's laying down and keeps the Vick's container near her, she can sleep and the Vick's keeps everything open. She wouldn't really cough. As far as getting the second Covid 19 vaccine, her allergist told her to do what the pulmonologist said to do and not get the second vaccine. Her regular doctor and the Ear, Nose, and Throat doctor told her to go with her gut on receiving the second Covid 19 vaccine. She went to the facility where she received her first Covid 19 vaccine and explained her story and told the staff she was scared. The caller started coughing during this interaction. The staff member looked at the caller and told her she will not give her the second Covid 19 vaccine because of the way she's coughing. She had not had the breathing test by the pulmonologist at this point in time. The breathing test was the very next day. She's called the CDC and her friends do call her special and that she's weird and should walk around in a bubble. Like, pot smoke, or marijauna smoke makes her get a massive headache and migraine. She's also allergic to nuts and apples. She asks, who in the world is allergic to apples? The CDC said they could not help her, the CDC suggested she file online with VAERS. When she contacted VAERS they asked if any of her doctor's reported her information. She filled out the link for VAERS and she's just looking for guidance. She wants to get the second Covid 19 vaccine but doesn't want to have this cough for the rest of her life. She's on her fifth week of not being able to work because of this cough. Only in the last two days has she been feeling a little better. Two days isn't long enough to let her know the cough is gone. VAERS told her yes, her cough is a side effect but what does she do now? VAERS can't guide her. She's not looking for medical advice, she's looking for data. What happened to the people who had her reaction? What happened to them? Can she be referred to someone who can help her? She's scared to get the second Covid 19 vaccine. She has GOOGLED looking for information until the cows come home. Her father is convinced it's all in her head. Out of the four doctor's she's seen, 2 of them are telling her to use her best judgement and 2 are telling her not to get it. The pulmonologist told her he had not seen enough cases like her to know for sure. She reports her arm was sore the night of the vaccine and she couldn't sleep on it. On Saturday, 27Mar2021 her arm was definitely more sore, by Sunday, 28Mar2021, her arm was moderately sore, her arm soreness was gone by Monday, 29Mar2021. She decided to get the Pfizer Covid 19 vaccine because it had less preservatives and she has reactions to preservatives. Her primary health care doctor is what she calls a "Doc in a Box". Since her COBRA health insurance ran out she's on Medicaid through a United Health Care Community plan. She had to switch doctors. Her new primary care doctor, (withheld) is in the new clinic. She thinks her last Covid 19 virus rapid, PCR and the antibody test was on 02Apr2021. She had another Covid 19 virus rapid and PCR test on 19Apr2021 she thinks. She isn't exactly sure of the date, she doesn't remember. She's not a big medicine person. She doesn't like taking a lot of medicine. The last vaccine she had was probably a Tetanus vaccine, however long ago that was. She's also allergic to Sulfa. She got a very bad rash. Her reaction was years ago. She does not have the NDC/Lot/Expiry. If she decides not to get her second Covid 19 vaccine, how long does the first Covid 19 vaccine last? When she got the first Covid 19 vaccine did she get Covid 19 antibodies? Would she show up as having Covid 19 antibodies? Physician Office visit yes for cough. Is there a Product Complaint: Yes Description of Product Complaint: also saw an allergist and the allergist wanted to put her on an Albuterol inhaler but it didn't help and only gave her a headache. NDC/Lot/Expiry for Albuterol not known. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-07-29 tingling, feeling hot Red face; Tingling sensation; General feeling of fullness throughout the face; Face hot; This is a s... Read more
Red face; Tingling sensation; General feeling of fullness throughout the face; Face hot; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, hypertension and environmental allergy. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN) all taken from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 (30 minutes after the vaccination), the patient experienced hot and red face. Then followed by patient experienced tingling sensation and general feeling of fullness throughout the face. Patient checked in the mirror for facial swelling. The sensations of tingling and fullness continued for 30 to 45 minutes then subsided and face continued to be hot, red for 6 hours following the vaccination. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events red face, hot face, tingling sensation, general feeling of fullness throughout the face and facial swelling were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
57 2021-01-01 weakness, pain in extremity Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired.... Read more
Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired. Arm bruised and more sore than regular I'M injection. Feeling "off".
57 2021-01-01 weakness On the evening of Sunday December 27th I became violently ill. I began vomiting and continued all n... Read more
On the evening of Sunday December 27th I became violently ill. I began vomiting and continued all night long. I had severe body aches and chills. I was unable to find my thermometer so am not sure of tempertature. I had lower back pain so severe I couldn't lie down. I tried to take Tylenol but was unable to keep it down. By morning I got access to Tylenol suppositories, Dramamine, and a thermometer. My temperature before Tylenol was 104.4. These symptoms continued over the next 3 days though vastly improved with Tylenol, Dramamine and IV fluids. I received a negative COVID test on Thursday. I have only been this ill once before in my life. By Thursday I was not longer febrile, only weak and exhausted. I have to now determine whether or not to get the second vaccination. I know this seems to be a somewhat delayed reaction. Any advice would be appreciated.
57 2021-01-02 weakness Patient received vaccine and was fine through her 15 minute observation period. She left the clinic ... Read more
Patient received vaccine and was fine through her 15 minute observation period. She left the clinic and came back about 40 minutes later complaining of tingling in her tongue and weakness in her legs and felt like she needed to sit down. Her blood pressure was taken and it was elevated and a decision to take her to the ED was made. In the ED, she denied shortness of breath and did not have any other signs of anaphylaxis. She was given diphenhydramine 50 mg (at 11:36AM), famotidine 20 mg (@11:36AM) and prednisone 50 mg (at 11:43AM). At 12:23PM, documentation from the ED notes that tongue symptoms resolved, but patient still felt weak.
57 2021-01-03 feeling hot, tremor right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headach... Read more
right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headache. I also had a chlorine taste in my mouth. I told the nurse I wasn't feeling well. she sat with me and was asking about how I was feeling. I the started trying to clear my throat. it felt like I had something in my throat. I kept trying to swallow and it just felt like my throat was getting tighter and tighter. that's when they got me on a stretcher and took me to the ER
57 2021-01-03 feeling of insects crawling on skin Itchiness in scalp, face and both arms that feels like bugs crawling on my skin, since 1/3. Nausea... Read more
Itchiness in scalp, face and both arms that feels like bugs crawling on my skin, since 1/3. Nausea and diarrhea on 1/4 in the morning, and still have the itching.
57 2021-01-03 numbness Numbs hands and feet, elevated blood pressure and tachycardia.
57 2021-01-03 tremor, feeling of body temperature change, numbness 10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experienc... Read more
10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experiencing hot/cold episodes, shaking, and pallor of lips. She also reported intermittent nausea. No changes in mental status. Patient was transferred to the ER. In the ER, she denied shortness of breath, facial swelling, hives, vomiting or diarrhea. No chest pain or voice changes. Her EKG was unremarkable. Her symptoms resolved with time, and was discharged on prednisone 20 mg PO for 4 days
57 2021-01-04 weakness 01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss conscio... Read more
01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss consciousness. Pt was aroused by Spouse to awake after fall and checked pt blood pressure 115/63 and sugar levels 93. Pt feeling weakness afterwards, pain in back and neck from fall. Awaiting calls from PCP and Neurologist for appointments.
57 2021-01-04 flushing Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swel... Read more
Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swell and break out in hives. Approx. 45 minutes later she became flushed, felt lightheaded/intoxicated/giddy/silly while driving home. She said she was extremely hungry ("like a big dose of steroids"). She states her ears were ringing and when she laid down at 2130 she could feel her heart beating throughout her body. This AM she reports feeling "hungover/groggy/nauseated". She denied any lip/tongue swelling, any lip or extremity tingling, difficulty breathing, any injection site redness/heat/swollen/painful area, fever, chills, or ever having a vaccine reaction previously. Spoke with individual w/pharmacy. Advised to report to VAERS. Not an expected reaction. Possibly related to aleve vs. covid vaccine.
57 2021-01-04 migraine 48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 1... Read more
48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 12 hour after the injection, fever 99.1
57 2021-01-04 muscle twitching metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs... Read more
metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs; about 30 minutes developed itching and redness of both legs; Started immediately having dizziness; Right upper facial muscles started twitching around eye area; This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscularly on 16Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. After vaccination injection, the patient started immediately having dizziness from 16Dec2020 14:00 and then about 30 minutes developed itching and redness of both legs on 16Dec2020 14:30. About 2 hours after vaccine on 16Dec2020 16:00 went home still itching with redness, dizziness, developed mild headache and metallic taste. Right upper facial muscles started twitching around eye area. Took Benadryl and Tylenol went to sleep. Woke up 5 hours later, all symptoms gone accept still a little dizzy. By the next morning felt weird then by 24 hours everything resolved. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
57 2021-01-04 pain in extremity DEVELOPED SORENESS IN ARM, EXTREME FATIGUE, AND BODY ACHES.
57 2021-01-04 tingling First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I ... Read more
First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I also experienced headache, nausea, diarrhea and fever. I continue to have tingling in my face. I called employee health, and they told me to isolate. Because they were trying to rule out if it was COVID, but test was negative.
57 2021-01-05 difficulty speaking post nasal drip; cough; Hoarse voice; This is a spontaneous report from a contactable nurse (reporti... Read more
post nasal drip; cough; Hoarse voice; This is a spontaneous report from a contactable nurse (reporting for herself). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EK5730, expiry date not reported), intramuscular in 29Dec2020 12:00 at a single dose in the left arm as Covid vaccine. Medical history included diagnosis is hypothyroidism, and patient have had reaction to almost all medications, wherein PCP (primary care provider) thinks patient have a reaction to the coating on tablets and to capsules. Patient had no covid prior vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. About 20 minutes after receiving on 29Dec2020 12:00, started with post nasal drip, which caused a cough; hoarse voice. These symptoms lasted about 2 hours. Since they are not listed as side effects just wanted to share. Patient did have a negative covid test on the day of the vaccine (covid tested post vaccination on 29Dec2020). No treatments received for the events reported. The events were reported as not serious (not resulting in death, not life threatening, did no caused/ prolonged hospitalization, not disabling/Incapacitating, not congenital anomaly/birth defect). The outcome of the events post nasal drip, cough and hoarse voice was recovered on 29Dec2020 14:20.
57 2021-01-05 flushing, pain in extremity, numbness, tingling Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left ey... Read more
Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left eye and left forehead above the eye. The patient reported feeling ?out of sorts? with a tingling or numbness from her shoulder to her neck and tingling in the left side of her face. She felt light headed when standing and her feet hurt. She was given diphenhydramine 25 mg and observed for an hour and a half at which time she reported feeling better . Her temperature was 97.5 F at 13:23 and 97.9 at 13:45. She left work early and went to the walk-in clinic later that evening. She reported that the clinic said all of he vital signs were normal and they did not note any specific problems. She took second diphenhydramine 25 mg. She was contacted at around 8:30 AM on 1/6/2021 and reported that she was feeling better.
57 2021-01-05 flushing 10 minutes after receiving vaccine, developed flushing and tingling of tongue. 45 minutes later, dev... Read more
10 minutes after receiving vaccine, developed flushing and tingling of tongue. 45 minutes later, developed nausea. 1 hour and 45 minutes after vaccine, developed laryngitis. Sent to ED for evaluation and treatment. Received Solumedrol and Pepsid in ED with improvement. Discharged home by or before 8pm with resolution of laryngitis and other symptoms. Reports "feeling great" this a.m.
57 2021-01-05 night sweats Mild URI symptoms started approximately 4 hours post vaccination. By 6 p.m. (5 hours post vaccinatio... Read more
Mild URI symptoms started approximately 4 hours post vaccination. By 6 p.m. (5 hours post vaccination), severe chills and fever of 105. Took 800 mg of Ibuprophen and 50 mg of Benadryl. Temp down to 102 by midnight. Fevers persisted, especially at night with extreme night sweats for 11 days often requiring a change of clothing up to 6 times through the night. No further respiratory symptoms past initial presentation. Night sweats have persisted but with less severity as of Day 15. Please note, I am also a healthcare provider and infectious disease epidemiologist, hence enterring my own VAERS.
57 2021-01-05 tingling Described started "itching 30 minutes after shot administered. That night she noticed a "rash all ov... Read more
Described started "itching 30 minutes after shot administered. That night she noticed a "rash all over her body, no problems breathing". The next day she experienced "swollen lips and tingling and itching from head to toe". She reports she is taking Pepcid and Benadryl. She also reports " no problems with breathing".
57 2021-01-05 tremor, weakness, difficulty speaking Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakn... Read more
Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
57 2021-01-05 tremor, pain in extremity Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a h... Read more
Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a headache about one hour after. Took 1000 mg of Tylenol; and I was feeling okay. Just arm was sore. Not extremely sore. 8 pm at night - started shaking; knees were knocking together; severe chills; and it took a few minutes to recognize what was happening - took temp. 99.4; took another 1000mg tylenol; went to bathroom and without notice - puked; woke up an hour after going to bed with worsened chills; 10:30 pm - temp 102.4; too early to take more Tylenol and so took pharmacy's version of Nyquil. Slept through the night after Nyquil but woke up with chills continuing - temp 103. 8 at 4:30 am; and then sat at side of bed and took tylenol 1000 mg and got up to go to bathroom and couldn't walk forward and felt my arm hurt really really bad; couldn't walk forward; I leaned against the wall and bounced against the next wall and kept walking and grabbed a bedroom doorknob and got into the bathroom and fell on toilet and then crawled to couch because I couldn't walk straight. Stayed on a couch for two hours and then it was gone. Fever and chills continued that whole day on 24th. Didn't eat/had no appetite. Christmas day -no fever. Felt shaky though - like I'd been super sick. No appetite still. Felt woozy and shaky inside (felt shaky inside) and that lasted for several days. Appetite still remains poor. 02 stats were low through all of it - four liters (up two liters than normal. Contacted: a pulmonologist - Dr. and she helped with O2 questions.
57 2021-01-06 weakness Patient reported pain and weakness
57 2021-01-06 feeling hot WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WI... Read more
WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE ED.
57 2021-01-06 flushing 57 yo F, healthcare worker, with history of asthma and penicillin allergy who presented to emergency... Read more
57 yo F, healthcare worker, with history of asthma and penicillin allergy who presented to emergency department for reaction to COVID-19 vaccine. Patient received first dose of COVID-19 vaccine (Pfizer) and immediately became flushed, erythema to trunk and face, and intensely pruritic. No signs of airway involvement or wheezing. Vitals were stable. Patient was treated with benadryl which improved symptoms. Anaphylactoid reaction.
57 2021-01-06 muscle spasms, pain in extremity Muscle spasms in neck within 1 hour of receiving vaccine. Severe cramp L calf less than 24 hours af... Read more
Muscle spasms in neck within 1 hour of receiving vaccine. Severe cramp L calf less than 24 hours after receiving vaccine. Both these symptoms continued until medical evaluation on 07 Jan.
57 2021-01-06 pain in extremity, migraine On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early a... Read more
On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early am got up at 5 am. Took Tylenol 1000mg. Went to work. Around 9am of 1/6/21 chills more pronounced body aches. Temp 99.3. Continued to feel poorly, rechecked temp 1.00 pm. Now 99.9. Sent home. At 2:15 pm temp 104.00. More severe chills and body pain, nauseous. Toast for dinner, Tylenol again at 6 pm , recheck temp 100.8. Went to bed. 1/7/22 am some body aches, not as severe, nauseous and migrai. Type headache. Did no take temp, because didn't feel one. Call to nurse at covid vaccine holiness. Check temp while on phone 97.4.
57 2021-01-06 pain in extremity Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in... Read more
Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in her neck; sick; She doesn't know if she had the flu bug or not; She also had very high blood pressure. It was through the roof/Blood pressure was high and she was concerned she would have a stroke; Muscle soreness; Arm soreness; This is a spontaneous report from a contactable healthcare professional (physical therapist). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 21Dec2020 08:15 at a single dose for COVID-19 immunisation; and sumatriptan from 25Dec2020 to an unspecified date at unknown dose and frequency (standard unknown dose/ She only gets 9 pills a month) for migraine. Medical history included ongoing migraine, obesity (She would say she was kind of obese), coeliac disease (She had Celiac disease and cannot eat gluten which was diagnosed since she was 4), chronic back pain (this was diagnosed a couple of years before she took the COVID vaccine), spinal stenosis (this was diagnosed a couple of years before she took the COVID vaccine), and pain (she took hydrocodone for pain but did not take any that day). Concomitant medication included hydrocodone for pain. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were none. The patient had the vaccine on 21Dec2020, and she got sick on Christmas day. She was vomiting at 14:00 and did not know if it was a side effect or not. She did have arm soreness muscle soreness at 15:00, that evening and the next day too. She normally gets a migraine once a month. She does not normally throw up with a headache though. The vomiting started when she threw up twice on 25Dec2020, then once on morning of 26Dec2020. She also had very high blood pressure. It was through the roof. She did not know if that was related to drug for migraine or vaccine. She also had the headache at 14:00 the whole time. She believed she threw up before she took Sumatriptan. The muscles got rigid and tight in her neck and she doesn't think she took it. She threw up and then she took it. She did not have a lot or expiration. There was no ER nor physician's office required. She would have it if her car was not buried in snow. Her blood pressure was high and she was concerned she would have a stroke. It was usually around 110/70 and was always very low usually. She did not know if it was accurate, but it was 165/124 at one point and she did know her pulse was accurate. She did not provide her pulse rate. She did not know if she was throwing up because her blood pressure was high and did not know if blood pressure was high because of Sumatriptan. She only gets 9 pills a month. She did not know if high blood pressure was one of the side effects. It was not a real safe medication to take once a day. She only took it once a month and only once that day. She had never thrown up with migraines before and was just concerned. She doesn't usually take her blood pressure and doesn't know if the Sumatriptan always makes it go up or not. She doesn't know if she had the flu bug or not. The action taken in response to the events for bnt162b2 was not applicable, while for sumatriptan was unknown. Clinical outcome of sickness and influenza was unknown, for headache was recovered on 27Dec2020, while for the other events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the elevated BP and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-01-06 tingling pt c/o tingling in B/L arms and head. pt stated she was a "bit" dizzy at first but sx subsided. Pt s... Read more
pt c/o tingling in B/L arms and head. pt stated she was a "bit" dizzy at first but sx subsided. Pt sat in view of Rn for extended time period. VS 198/108 HR92 SPO2 97. Pt VS rechecked BP 148/90 SPO2 97 HR 94 pt stated she felt better. Pt ambulated independently, RR even and unlabored, NAD noted, Skin NFR. Pt declined transport to ED.
57 2021-01-06 tremor ON 12/31/2020 I HAVE A HAD SLIGHT FEVER, HEADACHE , NAUSEA, BODY ACHES, CHILLS, HAND TREMORS, DIZZ... Read more
ON 12/31/2020 I HAVE A HAD SLIGHT FEVER, HEADACHE , NAUSEA, BODY ACHES, CHILLS, HAND TREMORS, DIZZY AND LIGHTHEADED THAT LASTED FOR 3 DAYS. SINCE THEN I HAVE A BAD HEADACHE, FEELING NAUSEA AND VERY LIGHT HEADED AT TIMES.
57 2021-01-07 pain in extremity, tingling, numbness, weakness burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swe... Read more
burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination. On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'. The patient did not received treatment as a result of the event. The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date, 'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date. Information on the lot/batch number has been requested.
57 2021-01-07 pain in extremity Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Sym... Read more
Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Symptom last about 24 hours.
57 2021-01-07 pain in extremity arm more sore than first shot; diarrhea- mild
57 2021-01-07 tingling, flushing Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. ... Read more
Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. in clinic for pt. assessment. Pt. uneasy/anxious with increased facial flushing to face and some mild swelling to lips. Pt. with tingling sensation to right side of body. Benadryl 100mg IM administered immediatly per Dr.'s order. Epi-Pen also available if needed. Pt. with improved redness to face and lips after administration.
57 2021-01-08 weakness Four days after vaccine, I began to feel sick, weak, headache, bodyaches, fever of 100.4, and thick ... Read more
Four days after vaccine, I began to feel sick, weak, headache, bodyaches, fever of 100.4, and thick nasal/sinus mucus.
57 2021-01-08 numbness, bell's palsy 2hours post began with tingling in tip of tongue and bottom lip. Took otc benadryl.48hours later all... Read more
2hours post began with tingling in tip of tongue and bottom lip. Took otc benadryl.48hours later all right side of face became numb.Was sent for evaluation by employer to hospital.dx with adverse reaction.bells palsy I was given Decadron IM and medrol dose pack.
57 2021-01-08 pain in extremity Temp of 100.2 left arm ache from vaccine (localized to injected limb) Narrative:
57 2021-01-08 pain in extremity Headache, Myalgia, Arthralgia, Extreme fatigue; arm soreness; subjective fever; Narrative:
57 2021-01-08 pain in extremity Fever Sore arm around 12 noon; chills 10pm for an hour, then fever 101-3F; relieved with tylenol
57 2021-01-09 migraine Severe Migraine
57 2021-01-09 muscle spasms Rigors, fever nausea, vomiting. diarrhea Severe muscle spasming/contraction, headache
57 2021-01-09 pain in extremity Painful arm 12/27/2020 Headache 12/28/2020 Low grade fever,severe headache, chills,nausea 01/06/202... Read more
Painful arm 12/27/2020 Headache 12/28/2020 Low grade fever,severe headache, chills,nausea 01/06/2021
57 2021-01-09 tingling Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadr... Read more
Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadryl 4mg Dexamethasone 1-10-21 @ 11:28am monitored and resolved by 12pm
57 2021-01-10 inability to speak experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elev... Read more
experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elevated blood pressure; This is a spontaneous report from a contactable Other-HCP(Patient). A 57-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm, on 22Dec2020 08:15 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included herpes simplex on lips, post menopause, elevated cholesterol w/lifestyle changes. Known allergies reported as no. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization. On 04Jan2021 08:30, the patient experienced symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure. The patient admitted to (Hospital name) (still here, hospitalization days reported as 2). Symptoms resolved except very mild aphasia. The patient had very few risk factors for TIA but did have family history of cardiovascular(CV) disease at young age, low density lipoprotein(LDL) was 192. The patient did not have diabetes, HTN, or known heart disease. She did not have severe anxiety. She did not smoke or use any substances. She walked about five miles 4x a week. Weigh reported as 157. Events reported as serious due to hospitalization. The patient had no Covid prior vaccination. Covid(nasal swab) was tested post vaccination on 04Jan2021, Covid test result was Negative. The event resulted in emergency room/department or urgent care. Treatment received for the adverse event included clopidogrel bisulfate(PLAVIX), acetylsalicylic acid (ASPIRIN), statin; potassium, CT, MRI, "telemet". The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
57 2021-01-10 weakness nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day ... Read more
nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day the vaccine was given. injection site pain swelling, severe headache, developed chills at night joint pains, rashes on my face, feeling weak as if I dont have energy. At night time i went to the restroom 5 times with an interval of 5-10 minutes and i cannot even control my bladder it comes out continuously. Slow to comphrend or response. I stayed fully awake the whole night on the night when the vaccine was given to me and was able to sleep only the following day (sat) at 5 pm.
57 2021-01-10 feeling hot c/o burning/ warmth to throat
57 2021-01-10 numbness muscle aches chills fever right knee where quad is, is numb
57 2021-01-10 muscle spasms Same exact signs and symptoms as Covid disease in April 2020. Fever, extreme headache, muscle pain, ... Read more
Same exact signs and symptoms as Covid disease in April 2020. Fever, extreme headache, muscle pain, chills, joint pain, extreme fatigue, weakness, GI symptoms, muscle cramps,
57 2021-01-10 pain in extremity Swollen knuckle at base of left thumb, pain when touched, pain with moving at first, including if ma... Read more
Swollen knuckle at base of left thumb, pain when touched, pain with moving at first, including if making a fist. Now pain when holding a mug or glass but not other movement. Still swollen at time of report 1/11/2021 but much less painful. On the 28th and 29th of December I took 200mg ibuprofen, 3 or 4 doses over the two days, with some benefit.
57 2021-01-10 pain in extremity HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER C... Read more
HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER COVID-19 VACCINE
57 2021-01-10 speech disorder, difficulty speaking Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled... Read more
Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled up; her hand and whole arm swelled up; Trouble breathing; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EK9231, exp date Apr2021), via an unspecified route of administration in the right arm, on 29Dec2020, at single dose, for COVID-19 immunization and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration, at unknown posology, on 29Dec2020 (20 minutes prior to taking bnt162b2), for anaphylactic reaction. Medical history included ongoing thyroid disorder. Concomitant medications included apixaban (ELIQUIS), diltiazem (unknown trade name), losartan (unknown manufacturer), rosuvastatin calcium (CRESTOR), levothyroxine (unknown trade name), ongoing levothyroxine sodium (SYNTHROID) for thyroid disorder and metformin (unknown trade name). Previously the patient received unspecified influenza vaccine (reported as flu shot) for immunisation, on unspecified date, and experienced anaphylactic reaction treated with Benadryl. On 29Dec2020, an hour after getting the vaccine, the patient experienced her voice became raspy, she could hardly talk, she could barely talk with outcome of unknown, her hand and whole arm swelled up with outcome of unknown, trouble breathing with outcome of unknown. The reporter stated that her voice and everything reacted and made her go to the emergency room on 29Dec2020. She reported that had adverse effect more than normal. The event "Her voice became raspy, she could hardly talk, she could barely talk" caused patient's hospitalization on unknown date. The action taken as a result of the events with diphenhydramine hydrochloride was post-therapy. Therapeutic measures were taken at the emergency room as a result of the events and included treatment with Topcid and Benadryl every 6 hours, 2x 40 mg of steroid. The information on the lot/batch number has been requested. Follow-up (02Jan2021): New information received from the same contactable healthcare professional reporting for herself includes: patient's details, medical history, events updated, vaccine lot# and exp date, concomitant, seriousness of event "Her voice became raspy, she could hardly talk, she could barely talk" added as hospitalization, historical vaccine, suspect Benadryl details, therapeutic measures updated.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
57 2021-01-10 tremor Approximately 15 hours after injection, was awoken with very severe chills and incontrollable shakin... Read more
Approximately 15 hours after injection, was awoken with very severe chills and incontrollable shaking. Was so cold, had to get a heating blanket to put over me, along with 2 blankets. Was shaking so bad, could hardly walk. Was slightly disoriented at the time. This lasted for 4 hours. Temperature is normally 95.6, did rise to 98.7. Had severe body aches that lasted until the next day, but were not as severe. the following day was very tired and muscles were achy. I did take tylenol, which seemed to help.
57 2021-01-10 tremor Received Phizer COVID 19 vaccine on Tuedsay, January 5, 2021. Friday am did not feel well, Congestio... Read more
Received Phizer COVID 19 vaccine on Tuedsay, January 5, 2021. Friday am did not feel well, Congestion, HA and CP. Friday evening shaking chills and fever with extreme fatigue. GI symptoms and congestion Saturday. Feeling better by Saturday evening.
57 2021-01-10 trigeminal neuralgia onset of trigeminal neuralgia in V1, V2 and V2 within 24 hours of 2nd dose. Notably pt has hx of in... Read more
onset of trigeminal neuralgia in V1, V2 and V2 within 24 hours of 2nd dose. Notably pt has hx of intermittent trigeminal neuralgia (3-4 previous flares in her lifetime) believed to be secondary to HVS infection. Sx have been present for 2 days and associated with headache, fatigue and mild sore throat. Pt will treat per usual with acyclovir 400 mg TID x 3-5 days.
57 2021-01-11 feeling hot, numbness dizzy; Felt hot; acutely numb; This is a spontaneous report from a contactable other healthcare prof... Read more
dizzy; Felt hot; acutely numb; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 13:45 at a single dose on left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took cortisol [cortisone acetate]. The patient felt hot and acutely numb and dizzy within first few moments on 06Jan2021 13:45. The outcome of the events was recovered 06Jan2021 13:45. No treatment received for the adverse events. The reporter assessed as the events as non-serious. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Batch/lot was not available/provided to reporter at the time of report completion. Information about lot/batch number has been requested.
57 2021-01-11 flushing pt reported flusing sensation, face felt normal. Felt heart racing, h was 90's. some mild tingling a... Read more
pt reported flusing sensation, face felt normal. Felt heart racing, h was 90's. some mild tingling around lips, pt was calm sitting on chair
57 2021-01-11 tingling At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describ... Read more
At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describes sensation as tingling throughout her head and body. Denies shortness of breath, difficulty swallowing, tingling of the tongue or lips or lip/tongue swelling. Denies palpitations or tachycardia. Patient states that she did not eat breakfast this morning. Initial BP 151/92, HR 62, 96% on RA. Patient states that she did take her morning dose of metoprolol. Response team was called for patient to be further assessed. Repeat blood pressure at 08:42 was 124/82, HR 62, 96% on RA. Team assessed patient. Patient provided water and crackers. Physician instructed patient to be monitored for 20-30 minutes. 08:56, BP 136/82, HR 66, 97% on RA. Patient verbalizes resolution of all symptoms. Patient discharged from clinic ambulatory and stable at 09:25.
57 2021-01-12 face paralysis Bell's palsy HISTORY OF PRESENT ILLNESS Patient is a 57 y.o. female with a history of glaucoma, pre... Read more
Bell's palsy HISTORY OF PRESENT ILLNESS Patient is a 57 y.o. female with a history of glaucoma, pre-diabetes, and osteoporosis s/p recent fibular fracture who presents for facial weakness. Patient is a research MD in the neurology department. Patient reports that she woke up this morning with weakness of the right face and inability to close the right eye. She reports mild discomfort in the area of her right jaw, but no ear pain. Denies any change in hearing or taste. She denies any difficulty chewing or swallowing, but has noticed that water will come out the side of her mouth when she tries to drink. She reports mild dry eye on the right. No history of similar symptoms. Today is day 18 after her first COVID vaccination. No recent URI symptoms. No unilateral numbness or weakness. No autoimmune history.
57 2021-01-12 feeling jittery, flushing immediately after vaccination had flushed feeling. dizziness, and "jittery. diarrhea started 18 hrs ... Read more
immediately after vaccination had flushed feeling. dizziness, and "jittery. diarrhea started 18 hrs after
57 2021-01-12 numbness, tingling C/O LEFT ARM NUMBNESS/TINGLING POST VAC. SHOT. EMS ON SITE. 1035: VS: 02 SAT R.A.: 98%, P: 95, B... Read more
C/O LEFT ARM NUMBNESS/TINGLING POST VAC. SHOT. EMS ON SITE. 1035: VS: 02 SAT R.A.: 98%, P: 95, BP: 147/82; T: 98.1 DEG. F. 1050: LEFT FACILITY, NO COMPLAINTS.
57 2021-01-12 numbness Numbness of Left hand with 2-3 minutes of injection. Completely resolved with 8-9 minutes of onset.
57 2021-01-12 pain in extremity, muscle spasms Stiffness soreness cramping severe pain. Unable to flex hands due to pain. Severe pain thru entire b... Read more
Stiffness soreness cramping severe pain. Unable to flex hands due to pain. Severe pain thru entire body lasting 3 days
57 2021-01-12 pain in extremity Chills, fever, headache, body aches, upset stomach, pain in arm of vaccine
57 2021-01-12 pain in extremity severe pain in right arm, and diffuse body aches, headache
57 2021-01-12 pain in extremity Arm soreness headache
57 2021-01-12 pain in extremity Sore arm almost immediately, lightheadedness for a few hours, then onset of severe headache, body ac... Read more
Sore arm almost immediately, lightheadedness for a few hours, then onset of severe headache, body ache and shaking chills. Improved with Tylenol. Today still achy but I've continued the Tylenol.
57 2021-01-12 tremor severe tremors,tachycardia
57 2021-01-13 weakness I had fatigue, headache, pain, weakness and I was so miserable decided to go to ER on (12/24/20) and... Read more
I had fatigue, headache, pain, weakness and I was so miserable decided to go to ER on (12/24/20) and then was transferred to hospital admitted (12/25/20) one day - discharged on 12/26/20 at night
57 2021-01-13 weakness throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Wa... Read more
throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.
57 2021-01-13 weakness Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous r... Read more
Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 15:00 on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hon, asthma and allergies: metronidazole (FLAGYL). Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced fever, weakness, horrific headache, body aches, and pain at administration site at 08:30 on 06Jan2021. The patient underwent Nasal Swab for COVID test with negative on 04Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications that the patient received within 2 weeks of vaccination. No treatment received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of events was recovering. Information on the lot/batch number has been requested.
57 2021-01-13 difficulty speaking Pt received covid vaccination (per pt, Pfizer vaccine) at a non-KP affiliated clinic. Within 10 min,... Read more
Pt received covid vaccination (per pt, Pfizer vaccine) at a non-KP affiliated clinic. Within 10 min, pt reports sore, pruritic throat, hoarse voice, difficulty breathing. Pt administered her own EpiPen and received a nebulizer treatment before transfer to ED. At ED, minimal residual symptoms but received prednisone and prn diphenhydramine.
57 2021-01-13 feeling cold Got vaccine yesterday 01/11/2021. Tuesday 01/12/2021: chill, fever, fatigue. Took Tylenol. Today ... Read more
Got vaccine yesterday 01/11/2021. Tuesday 01/12/2021: chill, fever, fatigue. Took Tylenol. Today 1/13/21 still a little fatigue. at work today. COVID negative 1/11/21 negative, getting tested every week. denies COVID exposure.
57 2021-01-13 migraine Adverse effect from the first shot was extremely tired and fatigued. Second shot migraine headache, ... Read more
Adverse effect from the first shot was extremely tired and fatigued. Second shot migraine headache, fatigued, body aches, nausea, pain throughout whole body.
57 2021-01-13 muscle spasms Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; Th... Read more
Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 06Jan2021 16:45 at a single dose on right arm for COVID-19 immunization. Medical history included, lactose intolerance. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.), probiotics (PROBIOTICS), clarithromycin (MACROBID [CLARITHROMYCIN]), ibuprofen (MOTRIN [IBUPROFEN]), paracetamol (TYLENOL). The patient previously took Parafon Forte and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ek5730) on 17Dec2020 17:15 at a single dose on left arm for COVID-19 immunization. The patient experienced aches, chills, menstrual like cramps, fatigue, eye burning, and low grade temp on 07Jan2021 15:00. The outcome of the events was recovering. The events were assessed as non-serious. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
57 2021-01-13 pain in extremity exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay ... Read more
exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay down and go to sleep; freezing cold; slightly nauseous; not feel as zippy as she normally do; Arm hurting a little; This is a spontaneous report from a contactable consumer (patient herself, a dental hygienist) via Medical Information team. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK5730, expiration date: Mar2021, NDC number was unknown), via an unspecified route of administration on the right arm (also reported as upper shoulder) on 07Jan2021 at 11:30 30 at a single dose for COVID-19 vaccination. The patient had no medical history. There were no concomitant medications. The patient reported she was feeling exhausted, freezing cold, slightly nauseous, and did "not feel as zippy as she normally do" on 08Jan2021. She wanted these effects recorded, and would like to know if they were normal, and would they happen to the same or higher intensity with the second dose. The patient further reported she had no adverse reaction on 07Jan2021 other than her arm hurting a little. Starting on 08Jan2021, she had felt exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous. She had been reading and was sure or was guessing this was normal, but wanted to verify that. She was not running a fever as of yet. Every time she tried to get up, she just laid back down. She felt fairly decent when she woke up, these events started later at the time of the report on 08Jan2021. She would not say these events were life threatening, but the CDC patient vaccine record card said to call to report any adverse events. She was scheduled for a second dose on 28Jan2021 and at this time did not plan to change dosing unless event worsening would occur. The patient had the vaccination, because she was always coming into contact with people with COVID at work. The patient had no investigation assessment. The reporter assessed the events as non-serious. The patient was recovering from the event "arm hurting a little," she was not recovered from the events "exhausted/exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous," while the outcome of the event "not feel as zippy as she normally do" was unknown.
57 2021-01-13 tingling, numbness tingling and numbness in Right hand (5 min) sweating and anxiety felt foggy 20 min.
57 2021-01-13 tingling tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; g... Read more
tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; given water& crackers - lightheadedness subsided but states is itching all over; offered to call 911 - refused. stated is going to primary care physician. total observation 45 min
57 2021-01-14 bell's palsy Bell's Palsy
57 2021-01-14 brain damage Confusion (encephalopathy) and fatigue. Onset about 10 hrs after shot. Did not know how to dial a ... Read more
Confusion (encephalopathy) and fatigue. Onset about 10 hrs after shot. Did not know how to dial a cellphone, did not realize I did not have glasses on, sent pt prescription to wrong pharmacy. Was also extremely fatigued. Slept most of 1/14/21. Confusion resolved 1/15/21, but still tired although better by 60% at 10 am on 1/15/21.
57 2021-01-14 pain in extremity After receiving the first vaccine, my arm hurt all the way to my wrist and became weak. Lasted almos... Read more
After receiving the first vaccine, my arm hurt all the way to my wrist and became weak. Lasted almost till I got my second vaccine. The second vaccine is causing the same thing. My muscles in my upper arm hurt really bad, the pain goes down to my wrist and my arm is weak. Its been 4 days since the second vaccine and its not stopped at all.
57 2021-01-14 pain in extremity Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt ... Read more
Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt swollen, especially the right. Within a few more hours my arm became heavy and I had some general muscular achiness. By approximately 11pm I had intense muscular pain on the back of my legs making it difficult to stand. It felt like I had been hit repeatedly with 2x4s. About that time my posterior ribcage hurt also. I couldn't sleep, turning frequently as my hips hurt. This is what I felt like when I had COVID. Intense pain. At 0630 (1/14) I got out of bed and felt I was going to faint, was extremely nauseous (I did not vomit) and had a very bad, global headache. I had to lay down again. My temp was 100.1 orally. I could not go to work. I was able to take Tylenol. It helped the pain but two hours later my temp was 100.8. I could not get out of bed until 6pm, I felt delirious when I tried. I was able to go to work on 1/15. Of note, following my first dose of COVID vaccine (Pfizer BioNtech Lot #EH9899 on 12/23/20) I had site soreness, heaviness of my left arm, T of 99.5 same day (about 10-12 hours post vaccination), and mild body aches for about a day.
57 2021-01-14 pain in extremity Dizziness, Body ache Teary eyes pain to right arm Headache
57 2021-01-14 pain in extremity Sore arm
57 2021-01-14 tingling 20 minutes after injection and after leaving the clinic, she developed a metallic taste in her mouth... Read more
20 minutes after injection and after leaving the clinic, she developed a metallic taste in her mouth, feeling of thick tongue, tingling from the neck to the top of her head. Took 25 mg Benadryl while in her car. No swelling and no respiratory distress. After 30 minutes, she didn't feel worse so she drove home (50 minute drive). Her symptoms resolved around 9pm (about 1 hour, 20 minutes after taking Benadryl).
57 2021-01-14 cold extremities, numbness, tremor low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body ac... Read more
low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body aches diarrhea nausea
57 2021-01-15 weakness Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled a... Read more
Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled area
57 2021-01-15 discomfort Day after 2nd shot fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain,... Read more
Day after 2nd shot fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain, unable to sleep, vomited once, took Tylenol, went to walk in at 7 am, did blood work, urine and Covid screen, all normal and negative, pain improved after about 15 hours Day 6 , today, pain came back, mild at 10 am and then severe at 11, nausea, vomited once, took Tylenol at 11 and feels better but still quite uncomfortable. Able to drink, normal stool, no other symptoms
57 2021-01-16 facial pain I had the same reaction with the first dose on 12/27/20, and it resolved, I received the 2nd dose to... Read more
I had the same reaction with the first dose on 12/27/20, and it resolved, I received the 2nd dose today and about 40 minutes after dose I had some tingling in lips, and then left sided facial pain, along cheek behind eye. hurts to smile and use that side of face. have taken a Benadryl I haven't read about this as a side effect. With the first dose this did resolved after 24 hours
57 2021-01-16 muscle spasms, burning sensation, pain in extremity Developed severe bilateral leg pains from pelvis to feet, sharp,cramping,burning, pain made difficul... Read more
Developed severe bilateral leg pains from pelvis to feet, sharp,cramping,burning, pain made difficulty walking , skin self like bad sunburn when touched. lasted approximately 36 hrs. For approx 12 more hrs moderate symptoms, then 24hrs minor symptoms. Started on Tuesday night resolved by Saturday morning.
57 2021-01-16 pain in extremity I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:0... Read more
I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:00 am) after the vaccine. The affected area has increased in size (about 2.5 x 1 cm now), and the finger is slightly swollen, with pain in the proximal interphalangeal joint when pressure is applied. Two days ago (1/15/2021; 8 days after vaccination), a small pruritic purple papule (2-3 mm) appeared on my ring finger over the distal interphalangeal joint, same hand, and the area is slightly painful when pressure is applied; today, the papule measures 3 x 5 mm. Skin lesions in both fingers are on the dorsal surface. I will seek medical attention.
57 2021-01-17 feeling cold Symptoms started 1/6/21 at 10 PM. Chills, body aches, no fever. Symptoms mild on 1/7/21 10am. Took T... Read more
Symptoms started 1/6/21 at 10 PM. Chills, body aches, no fever. Symptoms mild on 1/7/21 10am. Took Tylenol Xtra Strength.
57 2021-01-18 weakness Reported day following vaccination: headaches, unable to sleep, feeling very tired, and weakness beg... Read more
Reported day following vaccination: headaches, unable to sleep, feeling very tired, and weakness beginning day of vaccination
57 2021-01-18 weakness She was so weak; Muscles in her body are heavy/her muscles hurt so bad/Her muscles were aching and h... Read more
She was so weak; Muscles in her body are heavy/her muscles hurt so bad/Her muscles were aching and hurting to the touch; Muscles in her body are heavy and she can not hardly move; So tired; has not been feeling well; Her body was like a rock; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730 and expiration date not reported), via an unspecified route of administration on the left arm, on 08Jan2021 at a single dose for Covid-19 immunization. There were no medical history and concomitant medications (no other medications and never goes to the doctor). The patient previously took her first dose of bnt162b2 (lot number EK5730) on 18Dec2020 for Covid-19 immunization. The patient just had the second dose of the COVID vaccine on Friday, 08Jan2021. She had to go home from work on Saturday afternoon. She has not been feeling well. Her muscles in her body are heavy and she cannot hardly move. She was asking if that is a side effect? She is also so tired, she just cannot go. Her symptoms also started on Friday, that night. It woke her up. She got out of bed and her muscles felt like she could not move. Her body was like a rock. She tried to get up but her muscles hurt so bad. They were hard to the touch. Her husband tried to touch her and it hurt so bad she told him not to. Then on Saturday she was better in the day, went to work, then she was totally wiped out. Her muscles were aching and hurting to the touch. On 09Jan2021, she was so weak and went home. The patient did not received treatment for the events. She is unsure if she should go to her doctor today. She wanted to call Pfizer to see if this was a side effect first, and would go away, of if she needs to go ahead and let her doctor know what is going on and go in. Outcome of the event of weak was unknown and other events were not recovered.
57 2021-01-18 weakness slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not ... Read more
slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not able to work; chills; 102.9 F/low-grade temperature (99.2-99.8 F); This is a spontaneous report from a contactable nurse. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had side effects that are "fluctuated but up until now". She had 1 episode of chills (102.9 F), slight nausea, low-grade temperature (99.2-99.8 F) almost everyday, dizziness, body weakness, 3 types of diarrhea, starting to resolve, most concerned (lasting almost 11 days now). The patient received the first COVID vaccine on 29Dec2020 and she has been sick ever since. Patient was negative for COVID. She already sought help from doctor and went to the ER last night. She had slight to moderate symptoms and not fully recovered. She was not able to work. She was relating this to the vaccine as she was fine before. She went travelling back in March and became ill. They were not testing for COVID back then and she recovered. I wonder if I had COVID back then. She was glad it is her turn. She has been waiting a long time. It has been a concern. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses are expected for most people. On 30Dec2020 she had chills and temperature of 102.9. That subsided by taking Tylenol and rest. After that she felt sick like headache, dizziness, and low-grade temp until now. She hasn't been back to work. She has already sought advice from her doctor. She went to the ER last night to make sure she is ok because it was not resolving. Her COVID test was negative two days ago. Before the COVID shot she was healthy, working, and no symptoms of anything. After the shot, all this. Patient then asked if anyone else experienced these and if these were vaccine related. She would like to know what to do to confirm it was vaccine, how long will she be off work. The ER doctor said that she could have had the virus before she had the shot or after, but it is a slim chance now that she is COVID negative. Before she knew if she was COVID negative or positive, she went on the website and filled it out. Now that she has confirmed that she is negative what could cause this illness after the shot. She did that before she knew she was COVID negative. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses is expected for most people. Outcome of the event "102.9 F/low-grade temperature (99.2-99.8 F)" and chills was recovered, while outcome of the other events was unknown. Information on batch/lot number has been requested.
57 2021-01-18 burning sensation sharp pain R side of neck along dermatome; vesicles break out R anterior chest with mild burning and... Read more
sharp pain R side of neck along dermatome; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; minor shingles outbreak; skin irritation; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 10:15 at a single dose on the left arm for COVID-19 immunization. Medical history included Afib/ flutter, ablation, and total hysterectomy. Patient had allergies to food: grapes. Concomitant medications included fish oil, zinc, and estradiol (1 mg, 2x/week) transdermal patch. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. On 20Dec2020 at 09:00, the patient experienced sharp pain R side of neck along dermatome, vesicles break out R anterior chest with mild burning and itching consistent with a minor shingles outbreak. MD had examined it and his opinion was that the minor shingles outbreak was most likely triggered by the vaccine. Very mild but skin irritation was also present. No treatment was given for the events. Since the vaccination, the patient has not tested for COVID-19. The outcome of the events was recovering at the time of the report.
57 2021-01-18 migraine, tingling, numbness, pain in extremity, feeling of body temperature change, tingling, feeling of body temperature change, migraine, numbness, pain in extremity Arm soreness Migraine headache Nausea Hot and cold Fatigue Unsure of fever Numbness and tingling in ... Read more
Arm soreness Migraine headache Nausea Hot and cold Fatigue Unsure of fever Numbness and tingling in both hands
57 2021-01-18 tingling, numbness Vaccine at 3 pm at 5:22 pm LEFT facial, jaw, neck numbness and tingling. Resolved in 2 hours by 7 p... Read more
Vaccine at 3 pm at 5:22 pm LEFT facial, jaw, neck numbness and tingling. Resolved in 2 hours by 7 pm.
57 2021-01-19 weakness Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday... Read more
Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
57 2021-01-19 pain in extremity I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I w... Read more
I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I was very fatigued the rest of the day and had a headache. During the night I had chills and was dizzy. My temp was only 99.1 but I felt awful. I still had a temp this morning (day 2) No dizziness but I do have an awful headache and my arm is very sore where I received the injection.
57 2021-01-19 tingling Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, f... Read more
Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, face turned pale for few mins, hyperventilating
57 2021-01-20 feeling cold On the monday following my vaccination is very suddenly developed SEVERE chills. It took me three ... Read more
On the monday following my vaccination is very suddenly developed SEVERE chills. It took me three hours in a bed with electric blankets to get warm. Headache and body aches and tiredness. That day was the worst. And here is is 4 days later and I am still not out of the woods. I am still taking tylenol and advil for the body aches and chills and I have no energy
57 2021-01-20 feeling hot At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; ... Read more
At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; Red all over; Face swelling; Shot site was red; Allergic reaction; Hives; Around 8pm start to feel chill; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: el1284), via an unspecified route of administration on 09Jan2021 09:30 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included HTN, GERD, IBS, known allergies: PCN, IV contrast. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), linaclotide (LINZESS). The patient previously took morphine and percocet [oxycodone hydrochloride;paracetamol]; and experienced known allergies. The patient received first dose of bnt162b2 on 19Dec2020 09:30 at right arm. Lot number: el1284. The patient got the 2nd shot at 09:30, went back to work was fine, got home at 07:15pm, around 8pm on 09Jan2021 start to feel chill. On 09Jan2021 20:45, the patient was reported to be red all over, took 650 of Tylenol. Face swelling, the shot site was red. Went to bed at 9pm. Temp at 12am was 101. Went to the ER 12:50am. They stated the patient was having allergic reaction and hives (reported as 09Jan2021 20:45). The ER gave the patient Benadryl IV, Prednisone IV, Pepcid. They discharge the patient with Prednisone and Pepcid. On 10Jan2021 at 10am feel hot, on the same day took temp was 102.7. The patient had to miss work 1 day of work sunday 10Jan2021. The patient received treatment for the events. The patient visited the ER for the events. The outcome of the events was recovering.
57 2021-01-20 numbness, tingling Numbness and tingling to mainly L face as well as L arm and foot. Feeling as if I am going to pass o... Read more
Numbness and tingling to mainly L face as well as L arm and foot. Feeling as if I am going to pass out at any time. Have not passed out, just very "Fuzzy". Started approximately 15 minutes after injection and slightly worsened for the next two hours. After one night sleep, L face and L hand remain mildly numb and tingly as well as the foggy feeling mentally.
57 2021-01-20 pain in extremity hyperglycemia in the 400s; I have had no other problems following the vaccine other than a sore arm.... Read more
hyperglycemia in the 400s; I have had no other problems following the vaccine other than a sore arm.; This is a spontaneous report from a contactable Other HCP (patient). A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EK9231) at single dose at left arm on 08Jan2021 10:45 for Covid-19 immunisation, administered at hospital. Medical history included type 1 diabetes mellitus, allergies to adhesives. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication in two weeks included biotin (BIOTIN), insulin aspart (NOVOLOG INSULIN), ascorbic acid, bacopa monnieri, biotin, boron citrate, calcium, choline bitartrate, chromium, colecalciferol, copper, deanol, docosahexaenoic acid, electrolytes nos, folic acid, gamma-aminobutyric acid, huperzia serrata, inositol, iodine, iron, levoglutamide, magnesium, manganese, molybdenum, n-acetyltyrosin, nicotinic acid, pantothenic acid, phosphatidyl serine, pidolic acid, potassium, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopheryl acid succinate, trace elements nos, vaccinium myrtillus, vanadyl sulfate, vinpocetine, vitamin a nos, vitamin b12 nos, vitis vinifera, zinc (FOCUS FACTOR), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient experienced hyperglycemia in the 400s and a sore arm on 09Jan2021 14:30. She had no other problems following the vaccine. No fever. She cannot get her blood glucose level down. She has been at this range for 6 hours. The patient underwent lab tests and procedures which included blood glucose: 400. Treatment for event hyperglycemia was insulin pump continues increasing insulin. The outcome of events was not recovered. Post vaccination, the patient has not been tested for COVID-19. She was not sure if hyperglycemia was related to vaccine.
57 2021-01-20 pain in extremity Body aches; Heaviness in her chest; Pulse is in the 90s; Now her temperature was 101.2 degrees F; So... Read more
Body aches; Heaviness in her chest; Pulse is in the 90s; Now her temperature was 101.2 degrees F; Soreness in her left arm; Chills; Not feeling too well/flu-like feeling; Not feeling too well/flu-like feeling; Slight headache / headache; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unknown route, on 10Jan2021 at 15:00 at single dose in the left arm for COVID-19 immunisation. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ0140) administered in the upper left arm on 20Dec2020 (at 14:45-15:00) and developed a little headache, soreness and was tired (reported under AER 2021026236). Relevant medical history included thyroid, cholesterol and blood pressure (as reported). The patient was taking concomitant medications for underlying medical history. No other vaccine was received in four weeks. In the evening yesterday she was not feeling too well. She had a slight headache; body aches and she could get rid of the headache. She clarified that last night she felt chilly, she had the chills. By 10am this morning she did not feel well, she had a pretty bad headache and felt like she had a temperature. Her temperature earlier today was 99.4 degrees F and now her temperature was 101.2 degrees F. Her whole body feels like she was having aches, stated it is like a flu-like feeling, she had heaviness in her chest, her pulse will not go out of the 90s. She took her oxygen level and it was between 97-99%. She had also soreness in her left arm. She asked if these are common side effects, or something to be concerned about. Therapeutic measures taken as result of the events included ibuprofen (ADVIL). The outcome of the events was unknown.
57 2021-01-20 pain in extremity Reporter describes low grade fever (99.1-100F) and lower extremity body and joint aches starting app... Read more
Reporter describes low grade fever (99.1-100F) and lower extremity body and joint aches starting approx 14.5 hours after receiving the vaccine and lasting 36 hours. Treated with acetaminophen and ibuprofen. Injection site was sore x1 week - "felt like there was a baseball" in arm.
57 2021-01-21 inability to speak Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irri... Read more
Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irritation while in waiting area. Monitor personnel promptly identified patient?s condition and notified the team while staying with the patient ensuring she kept talking while the provider arrived. Officer in Charge was notified during the process and was at patient?s side approximately 0756; provider followed within seconds. Decision was made for immediate transport to ED. While in route patient stopped talking, coughed and grabbed throat prompting CPT to deliver x1 dose of Epinephrine to left deltoid at 0758 with provider?s consent. Shortly after dose administration patient resumed speech but continued to complain of dry and tight throat. Patient was able to continued speaking reciting ABCs and personal information when prompted. Patient did not experience altered mental status or loss of consciousness. Arrived to Emergency Department (ED) at 0805; report given to nurse and patient was checked in promptly. ED provider plan included observation until 1100 and discharge pending follow up assessment.
57 2021-01-21 bell's palsy Bell's palsy - left
57 2021-01-21 involuntary muscle movements Patient felt faint after 10 minutes. Fainted x 3 in lobby with Involuntary movements of right uppe... Read more
Patient felt faint after 10 minutes. Fainted x 3 in lobby with Involuntary movements of right upper extremity. EMS called. Patient transferred to ER.
57 2021-01-21 feeling cold 8 hours post - fever, severe chills - stink have 24 hours later
57 2021-01-21 pain in extremity Arm, Neck pain & severe nausea
57 2021-01-23 weakness By 830 pm I was aching, had a headache, by 9 bad chills, the fever, skin was very hot. Lasted all ni... Read more
By 830 pm I was aching, had a headache, by 9 bad chills, the fever, skin was very hot. Lasted all night. By am I was dizzy once, Achey all day, no energy. Slept all day. Today, dizzy again for a moment. Headache when I woke up. No energy, abit Achey. Not as bad.
57 2021-01-23 pain in extremity, weakness After the first shot I had a mild rigidity (more than my normal) of the thoracic muscles just below ... Read more
After the first shot I had a mild rigidity (more than my normal) of the thoracic muscles just below my breast line and of course a sore arm. After the second shot, 3 days after I woke after working all night to a demyelination response from my MS (which can be caused by weather, stress etc. Also, so did not think much about it) but 2 hours later my lungs started reacting from an overload of mucus (which has happened before after a vaccination so it was obvious my immune kicked in to find the changes going on from the vaccination) I immediately took steps to depress my immune system (mucus and cough syrup, Immersion in an Epsom salt bath with tea tree, lavender, eucalyptus, and peppermint oils (my own breathing treatment solution) 2 glasses of wine (relaxes the muscles, then took 2 Benadryl and 4 Motrin (which knocks me out and completely immobilizes) I have been doing this successfully for years) Today, I am very sore in the rib area, weak and tired (normal for a day after an episode) my lungs still weak (cough syrup is helping) Since this has happened before only after a vaccination or TB test I decided to report it for others who have MS, so they can be prepared. I self treat since my health care plan would drain my finances and affect my quality of life. I still think the vaccine is worth the episode, however, it will be my last Coved Vaccine, since I know it will cause a reaction.
57 2021-01-24 weakness Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contacta... Read more
Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer for herslf. A 57-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EL1284) vaccine , intramuscular in the right arm on 30Dec2020 10:30 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Since 03Jan2021, the patient has been sick. Her fever started out at 99.7 degrees Fahrenheit with a terrible cough and then it just kept getting worse. This weekend it was 102.7 degrees Fahrenheit all weekend. Her cough improved. She took some Delsyn one day. The cough improved but is not gone away. Headaches started on day 4 or 5. Lot of pressure in forehead and eyes. Fever kept going up day after day been up to 101.2°F and then up 102.7°F all weekend. Then she just felt weak all weekend. Just walking to bathroom is short of . Yesterday fever was 101.5°F and she went to doctor and they did a rapid COVID test and it came back positive. Slept a lot more this weekend. Done nothing but slept. She did not think it would make her this sick. only vomited once. she is supposed to get second dose on Saturday. She is afraid to get second. The patient also reported the following information: Fever 08:30 Terrible Cough 08:30 Headache 10:00 Weakness 12:00 Shortness of breath when walking 12:00 Increased sleepiness 12:00 Positive for Covid 09:21 Diarrhea 08:00 Vomiting 14:00 The patient underwent lab tests and procedures which included body temperature: 99.7 Fahrenheit; 102.7 Fahrenheit; 101.2 Fahrenheit then up 102.7 Fahrenheit ; 101.5 Fahrenheit. Sars-cov-2 test: positive on 11Jan2021 . Further information has been requested
57 2021-01-24 cold sweat Nausea, vomiting , cold sweats , throat warm, lethargic fatigue.
57 2021-01-24 pain in extremity 1/9/21 Fever 100.4, fatigue, and mild body aches lasting 1 day. 1/17/21 Began developing red areas o... Read more
1/9/21 Fever 100.4, fatigue, and mild body aches lasting 1 day. 1/17/21 Began developing red areas on left arm, which eventually blistered and extended from upper arm to thumb tip. Also associated with pain in the arm and hand. Physician diagnosed shingles on 1/20/21. Treated with valacyclovir.
57 2021-01-24 tingling, numbness Immediately felt numbness and tingling in arm and fingers
57 2021-01-24 sensory loss Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right ... Read more
Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right entire side from the back of my head, face and down to my right foot, which included my back scapular region and both right extremities; sore tender lymph nodes under right arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. Concomitant medication included levothyroxine. The patient previously took essential oils and experienced known allergies. The patient experienced tingling and numb tongue and lips, loss of sensation to her right entire side from the back of her head, face and down to her right foot, which included her back scapular region and both right extremities. Also, sore tender lymph nodes under right arm. All events started from 08Jan2021. This has been going on for 4 days as of 12Jan2021. No other vaccine in four weeks. Covid test done post vaccination: nasal swab on 12Jan2021, pending result. The outcome of the events was unknown. Information about lot/batch number has been requested.
57 2021-01-24 tenderness Elevation of the lymph node in the left armpit with tenderness
57 2021-01-25 weakness chills fever (evening) nausea vomiting (1x) diarrhea (3 days) body aches dizziness weakness tired fe... Read more
chills fever (evening) nausea vomiting (1x) diarrhea (3 days) body aches dizziness weakness tired feeling
57 2021-01-25 feeling jittery 100.4 Fever fro 24 hours , Teeth chattering, body aches, head aches, jittery feeling
57 2021-01-25 numbness, tingling Numbness & tingling hands & feet, throat itching, b/l ear itching
57 2021-01-25 numbness Left leg numbness; This is a spontaneous report from a contactable nurse (patient). A 57-years-old f... Read more
Left leg numbness; This is a spontaneous report from a contactable nurse (patient). A 57-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), intramuscular (left arm) on 23Dec2020 at 15:00 at a single dose for COVID-19 immunization. Medical history was not reported. The patient had no known allergies (NKA). The patient had no COVID prior vaccination. The patient is not pregnant. Concomitant medications included unspecified medications administered in two weeks; no other vaccines received in four weeks. The patient experienced left leg numbness on 25Dec2020 at 16:00. Treatment done for the event included tests and procedures which included magnetic resonance imaging (MRI) and X-ray-both with unknown results on an unknown date. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not tested post vaccination. The event was resolving. No follow up attempts are possible. No further information is expected.
57 2021-01-25 pain in extremity she is still tender in her left arm from the first shot/The first shot hurt way more and hurt all ov... Read more
she is still tender in her left arm from the first shot/The first shot hurt way more and hurt all over the whole arm, it was throbbing; she is still tender in her left arm from the first shot/The first shot hurt way more and hurt all over the whole arm, it was throbbing; This is a spontaneous report received from a contactable nurse (who is also the patient). A 57-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via intramuscular route in the left deltoid, on 18Dec2020 18:00, at single dose, for preventive/COVID-19 immunization, in the hospital. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included H1N1 flu shot (INFLUENZA VACCINE), in 2015 or 2016 (as reported), for immunization and experienced muscle stiffness and fatigue. The patient reported she is she is still tender in her left arm (unspecified date) from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing (unspecified date). The outcome of the events was not recovered. Information about lot/batch has been requested.
57 2021-01-25 tingling Starting itching, then face and lips started tingling. Took Benadryl and Pepcid. Next morning starte... Read more
Starting itching, then face and lips started tingling. Took Benadryl and Pepcid. Next morning started having difficultly swallowing, went to ER-1-6-21 On 1-7-21 started itching from all over, blood pressure was 262/106, went back to ER
57 2021-01-26 numbness Pt reported to POD for vaccine very anxious and concerned about her allergies to Nsaids, Morphine an... Read more
Pt reported to POD for vaccine very anxious and concerned about her allergies to Nsaids, Morphine and pnc. she reports that her they cause HA and facial swelling. Pt received vaccine at 1405 and went to 30 min observation area. at 1420 this provider was contacted by the patient and she reported that feeling numbness and drooping to the right eye lid. The patient was then brought for eval by this provider and EMT. The patient continued her observation until 1510 and at that time she reported that she was back to normal and continued to be without HA.
57 2021-01-26 pain in extremity Arm pain started around 4:30pm - hurt to pick up water bottle. Throat pain started 5:30pm - feels li... Read more
Arm pain started around 4:30pm - hurt to pick up water bottle. Throat pain started 5:30pm - feels like strep throat
57 2021-01-26 pain in extremity Severe fatigue, radiating arm pain, chills and mild headache
57 2021-01-26 pain in extremity Felt tired; Headache; Arm sore; patient tested positive and had the second dose of the vaccine; pati... Read more
Felt tired; Headache; Arm sore; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; This is a spontaneous report from a contactable consumer reported for self. This 57-year-old female patient received the first dose of BNT162B2 (Lot number ELD140, Expiry Date Mar2021) via unspecified route of administration on an unspecified date at single dose, and second dose of BNT162B2 (maybe the same Lot/ Expiry date as the first dose) via unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything. The patient clarified that she was tested positive at work. The patient had the nose swab 12Jan2021 at job and the patient had the second dose of the shot (vaccine). The patient stated that she felt tired in the morning and had headache and arm was sore, other than that the patient felt she was fine. The patient didn't have any chills or anything. The outcome of the events was unknown.
57 2021-01-27 weakness, migraine generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulde... Read more
generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulder, she thought it was cause of the injection site/muscle pain from the injection; pain in shoulder immediately after getting the injection and it was really swollen; body is in pain/lot of pain all of her body; achy like she is having flu like symptoms; injection was administered higher in her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 (16:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) injection in left deltoid/shoulder on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history was reported as "none". There were no concomitant medications. It was reported that the patient received the first dose on 22Dec2020 and the second dose on 12Jan2021. After she received the second dose of the vaccine, she immediately had pain in her shoulder, she thought it was cause of the injection site (12Jan2021 16:00). She had the pain in shoulder immediately after getting the injection and she got it at 4pm, and it was really swollen now. She mentioned this injection was administered higher in her left shoulder (pending clarification) and it feels like they may have gotten the injection in more of the arm muscle and she was thinking that is why she had muscle pain from the injection. She added that it was like her body is in pain, achy like she is having flu like symptoms that started the evening she got the vaccine, like 6PM or 7PM. The next day, yesterday (13Jan2021), she had a lot of pain all of her body. She also started to have a headache yesterday at noon (13Jan2021 12:00PM). The headache started at noon on 13Jan2021 and it continued for at least 8 hours and it was constant. It started to subside over the next 12 hours. She mentioned she also suffers from migraines (pending clarification). It feels like she is having residual migraine, like she is coming off of having a migraine. It is presenting, but she is not in severe pain. It is a feeling like she is coming off her migraine medication even though she did not take her migraine medication. She went to work yesterday (13Jan2021) even though she did not feel like it. She went home a few minutes early. She let her supervisor know she was in severe pain and had a headache. She was advised to stay home today and has not gotten better. However, the headache subsided. She feels foggy, like she could not just quite wake up. It is like she is in a daze or haze. She is having a hard time functioning. She continued to reiterate she was having a hard time concentrating. Now (14Jan2021) she is generally weak and is pale. In addition, the pain has not gone away. She stated she is weak, very weak. She felt it most of the day and it is worse today. She feels like she can hardly stand. She is trying to get fluids in her and trying to make coffee, however, it is a struggle. She stated, she has not gone yet, but she will call her doctor's office next and the health nurse as well to advise them she has been having symptoms. She stated she did not have a fever last night. Her temperature during the call was normal for her, 97.3. The outcome of events vaccinations site pain, vaccination site swelling, general body pain, flu like symptoms, weak, and pale was not recovered; while the outcome of other events was unknown. Information on lot/batch has been requested.
57 2021-01-27 weakness Chills, headaches, body aches, lethargic, and weakness
57 2021-01-27 pain in extremity, flushing Patient was getting hair colored about 6 hours after vaccine. Her face suddenly became very flushed ... Read more
Patient was getting hair colored about 6 hours after vaccine. Her face suddenly became very flushed and she experienced tachycardia for several minutes. Pulse was not checked. She then became extremely pale, light headed, and sick for 10-15 minutes. Chest was heavy in the evening from 8-9 pm so she took an antacid and went to bed. She woke up at 11pm, but body was still sleeping and she couldn't move. She has never experienced this before. Arm was very sore, but has improved. Has also been taking ibuprofen and Tylenol for body aches.
57 2021-01-28 feeling hot, tingling increased heart rate after that it started getting worse; a warm feeling in her chest like tingling;... Read more
increased heart rate after that it started getting worse; a warm feeling in her chest like tingling; kind of short of breath; left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand; Chills; Fatigue; GI problems; still have some issue, did not feel good, off and on; SARS Covid antibodies test says positive; This is a spontaneous report from a contactable other nurse (patient) from a Pfizer sponsored program Pfizer First Connect. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose (lot number: EJ1685) on Deltoid Left for covid-19 immunisation. Medical history included Paroxysmal supraventricular tachycardia. The patient's concomitant medications were not reported. The patient experienced a warm feeling in her chest like tingling; kind of short of breath, it went away like she said it was just breath it was like for couple of minutes and then it went away and then she was just fine till it's been long here honestly about 3 or 4 days later; got shot in her right arm but left hand start swelling up first a little bit and then her left arm start swelling up and it's just and then that's the base and then her right hand start very, very mild swelling in her right hand. The hospital think there as some clot or something weird but she did not and then that started going down after that it just started going down and went away and never had swelling since then but this was going to long but this was something weird happened to her. She got chills, She got fatigue. She had increased heart rate after that it started getting worse. She had Paroxysmal supraventricular tachycardia, she had that always but it's been control. She walked 5 miles daily a day, she was in shape, she had lot since then, so it's been under control, she never had problem with it until after she got the shot, her heart rate was she had to add medication, she never have to add. She took metoprolol (Treatment) so she added that and she added more and that's thing get it under control and then she take herself back off because she felt like it was under control but she had GI problems since, now she was getting better now, still have some issue, did not feel good, off and on. The patient underwent lab tests and procedures which included blood test: good on 04Jan2021 (blood work to see if something was going on to her heart, because she had short breath, and everything was good), weight: 166 or 164, SARS Covid antibodies test IgM on 04Jan2021: positive. Treatment: Nurse stated, "No, not now, I had a heart-rate monitor, it's what for see what is my heart rate, to locate and see what's going on." Outcome of left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand was recovered.; Sender's Comments: There is not a reasonable possibility that event heart rate increased is related to BNT162B2. The event is most likely due to underlying paroxysmal supraventricular tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-01-28 numbness fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected ar... Read more
fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included End-Diastolic Heart Failure, osteopenia and arthritis. Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-01-28 migraine headache like a migraine
57 2021-01-28 pain in extremity Sore arm for about 36 hours; On the 31st of December at 1:00 in pm. 100- 101.1 - fever and aches and... Read more
Sore arm for about 36 hours; On the 31st of December at 1:00 in pm. 100- 101.1 - fever and aches and chills for about 24 hours. I felt like I had a pressure/sinus headache. Got tested on Jan 2 - COVID negative; January 3 Urgent care - Doxycycline for 10 days. Took about two days on antibiotic and then I was fine.
57 2021-01-28 tenderness Neck pain/tenderness, Shoulder tenderness moving to right side, lymphadenopathy
57 2021-01-30 pain in extremity, numbness Face got numb for about an hour (30 min after ) Severe arm pain Fever Chills Delirium, couldn?t thin... Read more
Face got numb for about an hour (30 min after ) Severe arm pain Fever Chills Delirium, couldn?t think clearly Extreme fatigue Bad headache Whole body ached, especially back and neck Lasted about 48 hours
57 2021-01-30 pain in extremity right arm pain radiating into right anterior chest
57 2021-01-30 tingling, restless legs syndrome, slurring, weakness, coordination abnormal Paresthesia from the neck down, labored resp., weakness, poor coordination, blurred vision, slurred ... Read more
Paresthesia from the neck down, labored resp., weakness, poor coordination, blurred vision, slurred speech, rapid eye lid movement, uncontrolled leg moment. Given IV solumedrol, Ativan, and po Benadryl
57 2021-01-31 hot flush, weakness Patient states felt hot flashes following injection in waiting room went home became lethargic that ... Read more
Patient states felt hot flashes following injection in waiting room went home became lethargic that evening having difficulty answering questions at night patient states she became apneic and husband had to watch her breathe. Did not go to the ER. Patient states fully recover the next day and fully recovered 5 days later. No rashes fever generalized weakness that resolved.
57 2021-01-31 pain in extremity Fever, aches, chills, headache, exhaustion, fatigue for about 30 hours. Very sore arm for about 5 d... Read more
Fever, aches, chills, headache, exhaustion, fatigue for about 30 hours. Very sore arm for about 5 days.
57 2021-01-31 pain in extremity Driving home 40 minutes after vaccination ears and throat started to feel tight and felt like a lum... Read more
Driving home 40 minutes after vaccination ears and throat started to feel tight and felt like a lump in my throat , almost 2 hours after vaccination ears ringing and lump in throat. I took 2 Benadryl and in about hour the lump feeling was not as bad, lump feeling subsided. I had muscle joint pain the next 4 days and stayed on Benadryl those days until throat and ears felt better. On day 5 my left arm started stinging and broke out in hives , some on torso but mainly vaccinated left arm. I went to primary care to talk to her about my reactions on day -7 . She documented in my records but told me to report through Vsafe app. I did. I do not want to take 2nd dose after having this happened and no one able to tell me the 2nd wont be worse,
57 2021-01-31 pain in extremity Soreness in the arm; Conjunctivitis; Episcleritis; This is a spontaneous report from a contactable p... Read more
Soreness in the arm; Conjunctivitis; Episcleritis; This is a spontaneous report from a contactable physician (dentist, dental surgeon/patient's husband). A 57-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration on 30Dec2020 at 57-years-old at a single dose for COVID-19 immunization. Medical history included blood pressure increased, and blood cholesterol increased; both from an unknown date and unknown if ongoing. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) taken for blood pressure from an unspecified date to an unspecified date, "normal hormones" from an unspecified date to an unspecified date, "statin for cholesterol" from an unspecified date to an unspecified date. On 10Jan2021, the patient experienced conjunctivitis (non-serious). In Jan2021, the patient experienced episcleritis (non-serious). On an unspecified date, the patient experienced soreness in the arm (non-serious). The clinical course was reported as follows: The physician (patient's husband) stated that he and his wife received the Pfizer COVID-19 vaccine on 30Dec2020; and both had "a little bit of soreness in the arm, nothing spectacular." The patient developed a pink eye and was diagnosed with conjunctivitis 12 days (also reported as "approximately 10Jan or so") later after getting the vaccine (as reported). The doctor prescribed some topical cortical steroid eye drop. The eye was still swollen, and not totally resolved; "continually got worse." The patient consulted an ophthalmologist who gave the patient some prednisone ophthalmic (also reported as cortisone) and over the counter lubricant for the eyes. The patient was still symptomatic. The patient was diagnosed with episcleritis. The ophthalmologist classified the episcleritis as an autoimmune disease. Regarding the causality between the vaccine and the events, the patient's husband stated that his wife did not think it was related, and that the events could be totally idiopathic and there could be no correlation. The patient underwent lab tests and procedures which included COVID test: negative on an unspecified date. Therapeutic measures were taken as a result of conjunctivitis and episcleritis. The clinical outcome of the events was unknown.
57 2021-01-31 pain in extremity Soreness on the arm/ soreness at the site; felt a little achy/ achiness like you have on flu; I am C... Read more
Soreness on the arm/ soreness at the site; felt a little achy/ achiness like you have on flu; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140, reporter stated "could be ELO or ERO"), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included bronchitis from Oct2020 and ongoing and occasional cough. Concomitant medications were not reported. The patient reported that "I am a nurse I work with COVID patients. I got my vaccination on 28Dec2020. After the vaccination I had soreness on the arm and I felt a little achy. I felt like that with the flu shot (no further clarification) for couple of few days maybe. Then my whole family developed COVID and I am COVID positive. On 06Jan2021, I woke up with every COVID symptoms. I tested positive on the 7th. So, I have been in isolation for 10 days from work. The reason I called you guys is that I am getting 10 different answers. I am due to get my vaccination on 18th. I still have some symptoms and I did not know I am hearing where symptoms go away. I am concerned, my shot is not going to work. If I have mild symptoms can I get it? I am getting tensive for answers, she gave a little bit of information. Do you want me to tell you all my symptoms the time I contracted the COVID? What I told you about the shot was from 28th. Yes, the vaccination on the 28th was soreness at the site like achiness like you have on flu. I had bronchitis (Intent: History) back in at the month of Oct. I have an occasional cough. So, I do not even count that because that is being going on but then I got real sick with positive COVID on the 6th. I am concerned about getting my second shot. That is the reason of my call. The symptoms from the 28th is just what I told you. I have COVID so I am on a lot of medication right now. I am taking medications for the COVID. I am on budesonide (SYMBICORT) inhaler, albuterol (VENTOLIN) inhaler, I am taking acetaminophen (TYLENOL), guaifenesin (MUCINEX). As of Thursday I am taking ranitidine (ZANTAC) and some Steroids, pepper too and cough medicine as needed. When asked about causality, the patient stated "No because my whole family got COVID. Like my daughter, in-laws. It just went through our whole family. I do not think anything is related to the vaccine." Nurse added, "I do not really know what to do about this. If I feel better, I am just wondering if I should go ahead and get it because she told me there is no studies beyond that day. That was my main reason for the call." She was referring to the 'TCP'. "When I am going to get it if I am having mild symptoms because I do not want to lose my immunity. I am kind of troubling with myself what to do." The outcome of the event "I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID" was not recovered and of the remaining events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for corona virus infection based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity. It worth to note that the patient's whole family developed COVID.
57 2021-02-01 muscle spasms GI reaction with spasms; GI reaction with spasms; bloating and uncomfortable like you over eat and h... Read more
GI reaction with spasms; GI reaction with spasms; bloating and uncomfortable like you over eat and have tight pants in; bloating and uncomfortable like you over eat and have tight pants in; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at 04:30PM in left arm at single dose for COVID-19 immunisation at the age of 57-year-old. Lot number was 59267-1000-01. Medical history included no gall bladder, ongoing bloating and uncomfortable like you over eat and have tight pants in on 11Jan2021 at 02:00PM. Patient was not pregnant. Past drug history included allergy to codeine. Concomitant medications included venlafaxine, verapamil, tocopherol (VITAMIN E), ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM), atenolol (ALTENOL), zopidem tartrate (ZOLPIDEM). On 11Jan2021 at 02:00PM (also reported: wishing 2 minutes, as reported), inside stomachs and gut, the patient felt it spread over that area (not warm, not painful, weird) and afterwards that night bloating and uncomfortable like you over eat and have tight pants in, then the next day (on 12Jan2021, also reported on 11Jan2021 at 02:00PM, as reported) she had a gastro-intestinal (GI) reaction with spasms that were very painful (something that happens very seldom and the patient was sitting at her desk working so no irritable factors) so she had to take strong meds because this GI spasm was very painful and hurt when you breath, so she took strong medication (hyosymin and mepitab). The patient recovered with lasting effects from abdominal distension, the patient recovered from other events.
57 2021-02-01 pain in extremity Right arm was sore for about 3 days; This is a spontaneous report from a contactable consumer report... Read more
Right arm was sore for about 3 days; This is a spontaneous report from a contactable consumer reporting for a patient. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant at the time of vaccination. The facility type vaccine was hospital. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced right arm was sore for about 3 days on an unspecified date with outcome of recovered. Patient didn't receive treatment for the adverse events. The event was reported as non-serious. Information on the lot/batch number has been requested.
57 2021-02-02 weakness, tremor Weak, Tremor, Dizzy, Hypertensive
57 2021-02-02 electric shock sensation Electrical shots on right leg, right arm, upper back, then on my right side with head, nausea, heada... Read more
Electrical shots on right leg, right arm, upper back, then on my right side with head, nausea, headaches went to left side of the head and still with headache on 02/03/2021
57 2021-02-02 feeling hot I noticed the itchiness and heat about an hour after I received the vaccination. By the time I went... Read more
I noticed the itchiness and heat about an hour after I received the vaccination. By the time I went to bed at approximately 10 PM, the site was beginning to get very hard. By the next day, the site of the vaccination was the size of a baseball and very hard in addition to very red and itchy and painful. Benedryl eliminated the itchiness. However, it is five days later and there is still a very hard and a little less than half the size of a baseball. Most of the pain, heat and redness is gone, but the site is still very hard and itchy.
57 2021-02-02 muscle twitching My left eye hurts and feels like it's twitching. It is also getting puffy and once in a while a shar... Read more
My left eye hurts and feels like it's twitching. It is also getting puffy and once in a while a sharp pain shoots through my eye. Thanks.
57 2021-02-02 pain in extremity immediate pain in the opposite left arm, as well as neck pain on the right side from the chin to sh... Read more
immediate pain in the opposite left arm, as well as neck pain on the right side from the chin to shoulder, was seen in urgent care on 1/30/21
57 2021-02-03 pain in extremity EXTREMELY SORE ARM (UNABLE TO LIFT ARM), FEVER, CHILLS, UNABLE TO STAND LONGER THAN A MINUTE
57 2021-02-03 tingling, numbness, weakness Patient report generalized body aches, numbness, and tingling. Pt. reported feeling weak all over an... Read more
Patient report generalized body aches, numbness, and tingling. Pt. reported feeling weak all over and states that her right leg is weaker than her left leg. Pt. was brought to ER by her husband, because husband states that she was to weak to walk on her own to the bathroom. upon evaluation pt. appears tired and slightly drowsy but answers questions appropriately. The patient can state her name, where she is and the current month and year.
57 2021-02-04 weakness I woke up in the middle of the night with a headache and body aches. I got up to take ibuprofen and ... Read more
I woke up in the middle of the night with a headache and body aches. I got up to take ibuprofen and when I was in my bathroom, I collapsed. I do not remember actually falling but I heard the thud when I hit the floor. I tried to get up and had absolutely no strength in any part of body. My husband came to help me up but I could not even lift up my head. He was finally able to help me up and I took a few steps and collapsed/fainted again. This has never happened to me in my life.
57 2021-02-04 pain in extremity chills sore arm fever headache
57 2021-02-05 weakness, tingling General muscle aches and stiffness the day after the vaccine, fatigue, pain in right hip and weaknes... Read more
General muscle aches and stiffness the day after the vaccine, fatigue, pain in right hip and weakness in right leg causing difficulty lifting right leg requiring my to lift it with my hands to get in bed or to lift it into a foot rest. When lifting there was increased pain and tingling in my hip. The next day, the symptoms were resolved.
57 2021-02-05 weakness Chills/Fever 102.6 started hour 16 after vaccination with severe large bone aches which included fe... Read more
Chills/Fever 102.6 started hour 16 after vaccination with severe large bone aches which included femur, hips, pelvis, sacrum and scapula; body aches, back ache, headache, general malaise and weakness. 2nd fever, no chills 38 hours after vaccine, with continued bone and body aches, back ache and headache, general malaise and weakness. mild dyspnea with continued back ache after 50 hours, still experiencing this at the time of report
57 2021-02-05 pain in extremity RUE 4 in x 4 in large, painful, raised area that has decreased in size and pain but still remains.
57 2021-02-06 cold sweat Patient reports lightheadedness, clammy skin. Improved when supine. Patient has history of vasovagal... Read more
Patient reports lightheadedness, clammy skin. Improved when supine. Patient has history of vasovagal reaction with vaccine.
57 2021-02-07 burning sensation, feeling jittery Received vaccine at 5:45 p.m. I sat down to start my 15 minute wait and my heart started to race, w... Read more
Received vaccine at 5:45 p.m. I sat down to start my 15 minute wait and my heart started to race, was pounding, became jittery, felt pressure in my left jaw, couldn't catch my breath with mask on. I lifted my mask to be able to get air as I attempted to check my pulse rate, but it was too fast to count. I quickly took my coat off. I sat back down and was going to get help, but noticed my heart rate decreasing, jittering decreasing, and was able to breath with mask on. Pulse was down to 80 bpm. The skin on my face and neck felt like they were burning. The tip of my tongue felt tingly. All subsided until next day, felt fluish, temp 101.5.
57 2021-02-07 involuntary muscle movements First Vaccination on 01/13/21 right arm - pain at injection site for several days following. Brai... Read more
First Vaccination on 01/13/21 right arm - pain at injection site for several days following. Brain fog and some fatigue. Second vaccination on 02/3/21 left arm - approx. 3 hours later felt a little woosie and spacey. Pain at injection site. At approx. 3am the following morning experiencing chills and body jerks along with long deep breathing. Temperature 100.1. Also had a painful headache and full body aches along with some nausea and very fatigued and pain at injection site was growing in size and was also hot and red and swollen. Contacted primary care doctor about these side effects. On 2/5/21 the temperature reached 100.7 and the previous days aliments continued and fever came down to 99.6. Lots on pain in left side of neck and left arm. Let arm continues to be swollen, red and hot and is itchy. Fever finally broke on the night on Feb. 6th.
57 2021-02-07 pain in extremity Pfizer-BioNTech Covid 19 vaccine EUA- About 15 minutes after receiving the vaccine I had chills go u... Read more
Pfizer-BioNTech Covid 19 vaccine EUA- About 15 minutes after receiving the vaccine I had chills go up the back of my head. Severe HA started about 1600, body aches in joints and muscles began that night. Returned to work 2/3/21 as day progressed my HA became so bad I was nauseous, after 2 hors at work I had to go home. Fever of 100 that went to 101.7 the following day. HA was not relieved with Tylenol or ibuprofen . Arm was moderately sore no redness or swelling.
57 2021-02-07 pain in extremity My arm and shoulder were sore throughout the day and that evening it was really sore. I woke up at 3... Read more
My arm and shoulder were sore throughout the day and that evening it was really sore. I woke up at 3:00 in the morning and my head hurt very bad, and I woke up and I took two Tylenol and waited 20 minutes and then took alleve, drank four cups of coffee and half floreset and that helped a little bit and this morning I woke up with a terrible a headache and stiff neck and shoulder, and its only my left shoulder where I got the shot.
57 2021-02-07 tingling, feeling of body temperature change, breast pain At midnight the same day after the vaccine she awakened feeling cold, sweating, and had a temp of 10... Read more
At midnight the same day after the vaccine she awakened feeling cold, sweating, and had a temp of 101.6 F. Pt had fever for 24 hours. She took Tylenol at that time. Her face was also red after the second vaccine and has remained red around the lower half of her face. Her face tingles at times. She feels like bugs are walking on her face and body at times, get itchy at times, gets hot, then gets cold. Pt felt a zap like electricity in her bosom for on 1 day in her left breast/ chest fleetingly. She feels it, zaps, sometimes in other places in her body since then rarely, not daily.
57 2021-02-07 tremor, muscle twitching, cold extremities Started sweating, forehead, hands and feet- that night progressed to muscles twitching and shaking, ... Read more
Started sweating, forehead, hands and feet- that night progressed to muscles twitching and shaking, cold hands and feet, nausea, no appetite- shaking was all over at times, would come and go- had it first night, next day and night and less intense but still there 2 nd day and night
57 2021-02-08 cold sweat 20 minutes post injection started to feel clammy, increased heart rate and rash appearance on both a... Read more
20 minutes post injection started to feel clammy, increased heart rate and rash appearance on both arms and hands. Reported to doctor at site and EMS was called. Heart rate was 98, BP 218/110 taken three times by EMS. Administered Benadryl liquid by EMS and monitored for thirty minutes. Rash stopped spreading and improved heat rate and B/P. Was released to go home by EMT. While traveling home had to stop by roadside because of vomiting and nausea. Next morning rash still present on arms and fingers.
57 2021-02-08 flushing Post second COVID vaccination, started feeling a tingling sensation in her mouth and felt light-hea... Read more
Post second COVID vaccination, started feeling a tingling sensation in her mouth and felt light-headed. Reports that the first vaccine caused some "slight flushing". She was laid flat on a cot. VSS. Reported that her tongue was starting to swell. Rapid Response code was called and she was transported to the ED.
57 2021-02-08 tingling Immediate tingling of LA/face/leg; BP 152/82 (pulse 94), BP 146/77 (pulse 102). Called 911.
57 2021-02-09 burning sensation 103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it wa... Read more
103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it was burning; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) by injection once to right deltoid on 25Jan2021 at single dose for COVID-19 immunization. Medical history included she had COVID, she was diagnosed, was positive on 29Dec2020, and spent 9 days in the hospital. concomitant mediation was none. Patient calling about the COVID vaccine; her boss texted, she had to leave work, she had a 103.5 fever (26Jan2021), she felt horrible, she got her first COVID vaccine yesterday, and woke up this morning and felt horrible. a girl touched her arm, said it was burning, and she was very nauseous, and was trying to pass meds, and took her temperature and it was 103.5, and the thing is when you come into the facility, they took her temperature and it was 97.2, but those thermometers suck and she has an oral thermometer, and it was 103.5. It's improving. Also has severe back pain and body aches, she was scared with the fever. Felt nauseous this morning (26Jan2021), had chicken noodle soup and crackers, but it was pretty bad to point she had to pull the trash can behind her. she was on a ventilator in March for a week, not with COVID, she doesn't want to die, she thought she was going to die with COVID, she had every symptom. No Investigation Assessment. The last outcome of 103.5 fever, nausea and severe back pain was recovering, body aches was not recovered, outcome of other events was unknown. Reporter seriousness for 103.5 fever was Medically significant. For severe back pain, body aches and Nausea was Not serious. Relatedness of drug to reactions/events 103.5 fever, severe back pain, body aches and Nausea per source of assessment of Primary Source Reporter and Method of assessment of Global Introspection with drug result of Related.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event pyrexia and remaining events cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
57 2021-02-09 feeling hot, pain in extremity her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper ... Read more
her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper chest, the medial aspect of her left arm and down her upper arm initially pain/fingers ached; down her upper arm initially pain; About 15 minutes later her wrist and fingers ached/joint pain; a gradual increase of body aches; nausea; feeling 'hot'; Big time tired, fatigue the patient would go to bed early; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at Arm Left on 25Jan2021 14:15 at the 57 years old at single dose for COVID-19 immunization. The medical history included FAP (Familial adenomatous polyposis), hernia repair, ankylosing spondylitis, bipolar disorder II, chronic depression, PTSD(Post-traumatic stress disorder), anxiety, GERD, Penicillin allergy, Adhesive tape allergy, Antiemetics allergy. The concomitant medications were amlodipine, ASA, HCTZ, lamotrigine (LAMICTAL), losartan, naproxen. The patient previously took Ciprofloxacin and experienced allergy, Ativan and experienced allergy. Right after the patient received the shot on 25Jan2021 14:30, her left side of her upper chest, the medial aspect of her left arm and down her upper arm initially pain. About 15 minutes later her wrist and fingers ached. From then on 25Jan2021 14:30, a gradual increase of body aches and joint pain, some nausea feeling 'hot' but not 'hot flashes' no sweats, Big time tired, fatigue the patient would go to bed early. She was keeping very hydrated. There was no other vaccine in four weeks. There was no treatment for the adverse events. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was recovering. Information about lot/batch number has been requested.
57 2021-02-09 feeling of body temperature change She said ever since receiving the COVID-19 Vaccine, she has been doing nothing but sweating; She sai... Read more
She said ever since receiving the COVID-19 Vaccine, she has been doing nothing but sweating; She said she will be sweating, and then she gets cold, and then she gets hot; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL9261 on Arm, Left Upper at 10:35 on 22Jan2021 at single dose for covid-19 immunization.Medical history included : Type 2 diabetes mellitus (she has been a Type 2 Diabetic for over 10 years ).She said ever since receiving the COVID-19 Vaccine,on 22Jan2021, she has been doing nothing but sweating.She said she will be sweating, and then she gets cold, and then she gets hot .She said she feels like she is overheating. She said she is calling Pfizer to see what she should do. She said she hasn't called her doctor yet, and she is due to take the second COVID-19 Vaccine dose on 09Feb2021.Her sweating, and feeling cold then hot, started on Friday night, 22Jan2021. She said her face was even sweating when she was at work, clarifying she doesn't sweat like that. She said she was even sweating when she was sleeping. She said she will throw back the covers because she feels like she was overheating, and then 5-10 minutes later the heat dissipates, and she has to cover herself back up. This morning she had an episode of sweating, and thought her blood sugar was too high. She said she had just got out of the shower, and she was sweating. She said the ceiling fan was on. She said she was not feverish, but felt hot. She said she immediately checked her blood sugar, and her blood sugar was normal at 113.Her last blood work was in Dec2020. She said she she saw her doctor 3 weeks ago, and her blood work was OK.Outcome of the events was not recovered.
57 2021-02-09 flushing Tachycardia; dizziness; flushed feeling; sweating to hands and back of neck; This is a spontaneous r... Read more
Tachycardia; dizziness; flushed feeling; sweating to hands and back of neck; This is a spontaneous report from a contactable nurse reporting for herself. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:Ek4176), via an unspecified route of administration on the left arm on 12Jan2021 17:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, melanoma in situ, diverticulosis, allergies to sulfa, betadine and reacted to depo-medrol injection. Concomitant medication included lisinopril (LISINOPRIL), estradiol (ESTRADIOL), ibuprofen (MOTRIN) and cyanocobalamin (B12). The patient experienced tachycardia, dizziness, flushed feeling and sweating to hands and back of neck on 12Jan2021 17:30. Therapeutic measures (Benadryl 25mg) were taken as a result of the events. The outcome of the events was recovered on an unspecified date in Jan2021.
57 2021-02-09 flushing 1452 feeling "thick tongue" flushed tingling lips BP 187/101 HR 94 Benadryl 50mg po provided 1456 BP... Read more
1452 feeling "thick tongue" flushed tingling lips BP 187/101 HR 94 Benadryl 50mg po provided 1456 BP 146/90 HR 91 RR 20 Sats 98 1500 BP 133/91 HR 86 RR 18 Sats 98
57 2021-02-09 pain in extremity sore arm (briefer than with #1); malaise; fatigue; Pulsing tinnitus, eased off now; bad headache (pr... Read more
sore arm (briefer than with #1); malaise; fatigue; Pulsing tinnitus, eased off now; bad headache (prexisisting but markedly amplified-still; chills (no fever, 3 days for real, now fading); mild nausea/loss of appetite (largely resolved.); mild nausea/loss of appetite (largely resolved.); This is a spontaneous report from a contactable Physician reported for herself. This 57-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 09Jan2021 09:00 AM on Arm left at single dose (Lot # EK9231) for covid-19 immunisation. Medical history included Pacemaker, Insomnia, and some preexisting hearing loss, due to effusion. No known allergies. No covid prior vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 16:45 PM on Left arm at single dose (Lot # EH9899) for covid-19 immunisation. Covid test after #1 (December) due to sore arm, chills, aches and malaise. Was negative. No other vaccine in four weeks. Concomitant medications included other medications in two weeks. The patient experienced pulsing tinnitus, eased off now, also sore arm (briefer than with #1), malaise/fatigue (still but better), bad headache (persisting but markedly amplified-still, chills (no fever, 3 days for real, now fading), mild nausea/loss of appetite (largely resolved.) Events all on 10Jan2021 06:00 AM. Lab data included covid test (Nasal Swab) on 22Dec2020: negative. No treatments were received for the events. Outcome of events mild nausea/loss of appetite, malaise, fatigue was recovering. Outcome of the event chills (no fever, 3 days for real, now fading) was recovered. Outcome of the events was unknown.
57 2021-02-09 pain in extremity sore arm; Chills; aches; malaise; This is a spontaneous report from a contactable physician reported... Read more
sore arm; Chills; aches; malaise; This is a spontaneous report from a contactable physician reported for herself. A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899), via an unspecified route of administration in left arm on 19Dec2020 16:45 at single dose for COVID-19 immunization. Medical history included pacemaker, insomnia and some preexisting hearing loss, no known allergies. Concomitant medications included unspecified medication received in two weeks. The patient was no pregnant. There was no other vaccine received at the same date of the product and in four weeks. The patient had no COVID prior vaccination. The patient experienced sore arm on an unspecified date, chills, aches and malaise in Dec2020. COVID test (Nasal Swab) post vaccination on 22Dec2020 due to chills, aches and malaise was negative. No treatment received for the events. The outcome of the events was unknown.
57 2021-02-10 weakness, hot flush rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp... Read more
rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
57 2021-02-10 burning sensation, nerve pain bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid ca... Read more
bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; This is a spontaneous report from a contactable physician. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3284), intramuscular into the left arm on 11Jan2021, at 16:00 as second single dose for covid-19 immunization. Medical history included Obstructive sleep apnea from an unknown date, oligodendroglioma from 1996 (noted as history of oligodendroglioma status post resection 25 years ago with stable follow up and no residual deficits). The patient had no known allergies to medications, food, supplements or herbal remedies. There were no concomitant medications; Patient was not taking any OTC medications, prescribed medications, supplements or herbal remedies at the time as well as in the period prior to her vaccinations. The patient previously received BNT162B2 (lot number EH9899 ) on 22Dec2020. On 18Jan2021, at 08:00, the patient experienced bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands, which was medically significant and had not recovered, as it was persisting. This was elaborated as follows: patient experienced one week following 2nd Pfizer covid-19 vaccine patient developed bilateral feet, left worse than right, burning, itching sensation. the symptoms progressed up to her mid calves and to a slight extent. The events were considered medically significant. Details were as follows: The symptoms were quite intense and interfered with her life, requiring gabapentin prescription for control of neuropathic complaints. Patient denied any significant weakness, low back pain, neck pain, balance problems, dizziness, bowel or bladder involvement. Patient saw physician who performed workup for common associated etiologies of polyneuropathy, which were negative. Patient underwent EMG/NCS which were normal, and subsequently skin bx (skin biopsy) to rule out small fiber neuropathy (results pending). The patient further described the incident as a week after receiving the second dose of the covid vaccine, the patient experienced new onset bilateral feet burning that went into her upper legs, mid calves and to a slight extent in both hands. The burning was experienced more in the left foot than the right foot. Reports it was severe enough for the patient to reach out to her primary care provider. (PCP) to start Gabapentin for neuropathic pain. PCP ordered labs to rule out infection and other causes for neuropathy which all came back negative. Patient has no known underlying risk factors that would predispose her to neuropathy. Neurologist did an EMG which showed no evidence of neuropathy. The patient went into to the office, and she had a skin biopsy to rule out small fiber neuropathy. She does not have results to provide for the skin biopsy at this time, however, the neurologist feels if the skin biopsy is positive, there may be an association with the vaccine in regards to the burning pain the patient is experiencing. She is calling to ask if this is a reported side effect. Treatment was confirmed as gabapentin was prescribed by PCP, and the patient started on it a few days after the onset of the burning pain. Outcome was noted as it has not improved, and has not resolved. No COVID tested post vaccination was noted. The outcome of the events was not recovered; the condition was persisting. Causality for the events was noted as related.; Sender's Comments: Based on a compatible temporal association contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events pruritus, burning sensation, condition aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-02-10 flushing Describe adverse reaction: After administration at 15:45, patient hyperextended her neck/ head tilt... Read more
Describe adverse reaction: After administration at 15:45, patient hyperextended her neck/ head tilted back. Inhaled deeply, exhaled deeply, became pale and flushed in cheeks. Patient complained of pressure in her head. Transferred to wheeled chair , and moved to private holding room in Covid Vaccine Clinic. Pt complained of dizziness. Transferred with assistance to gurnee. AT 15:46: BP 153/98 in RA Pulse ox 95%, Heart rate 91 bpm, after just being placed in gurnee. Offered water, juice, and crackers. she declined. HOB at 45 degrees AT 15:53 vitals were: BP 147/59, pulse ox 96%, Heart rate 89bpm. Pt states less dizziness, and feeling a bit better. At 16:16: BP 148/84, Heart rate 86, Pulse ox 94%. Patient denies dizziness and headache. Says she is feeling better. Brough to sit at edge of bed for a minute. Standing for one minute. Then ambulating about room without dizziness. Patient states she feels okay to go home. Left to home with family member, who would be driving patient home.
57 2021-02-10 tingling, numbness numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness... Read more
numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness and tingling in mouth and cheek on left side; numbness and tingling in mouth and cheek on left side; This is a spontaneous report from contactable nurses. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left deltoid on 27Jan2021 16:30 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, hypothyroidism, and hypertension. There were no concomitant medications. Patient previously took lisinopril. On 27Jan2021, two minutes after receiving the vaccine, the patient experienced numbness and tingling in mouth and cheek on left side on the same side that she got the vaccine on, so she took 50mg diphenhydramine (BENADRYL), it went away and she slept all night. She then woke up and felt fine, with the exception of a little spot on the lip of numbness on 28Jan2021, so then she took 25mg Benadryl at 11:00 and it was gone all day. In the last 15 minutes her numbness was back and so she took another 25mg Benadryl at 17:00. Patient stated that she knows if this kept continuing she will have to go to the emergency room. In detail, patient had tingling on lips and mouth. The tingling traveled up her left side of the face to the bottom of her nose. Took 50mg of diphenhydramine after she got home. Woke up morning of 28Jan2021 with tingling on her lip, so she took 25 mg at that time. The tingling came back the afternoon and she took another 25mg and another dose before bed. She reports a small area of tingling on her lip remains as of 29Jan2021. She has not take any more diphenhydramine. She does not think it was Bell's Palsy.The reporter considered the event medically significant. Patient inquired if she can take the second dose of the vaccine and that she has done that before with lisinopril (not further clarified). Patient was to receive the second dose on 18Fe2021 or later. Patient did not have anything just right before the vaccine, has had no positive Covid or antibody test prior to the vaccine and no issues with vaccines in the past. The patient has recovered from the events, numbness and tingling in mouth and cheek on 28Jan2021 and outcome of the event, little spot on the lip of numbness was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
57 2021-02-10 tingling Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded with some t... Read more
Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded with some tingling in her extremities. EMS evaluated patient on-site. Patient was instructed to remove her mask and take deep breaths to settle her anxiety. Patient was hypertensive (175/104), SPO2 97%, and a FSBG of 95mg/dl. Several minutes later, the patient reported a return of dizziness and tingling. EMS obtained a 12-lead EKG that was unremarkable. Patient refused transport to the hospital.
57 2021-02-10 tremor, feeling jittery, weakness dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness... Read more
dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness; chills; tired; This is a spontaneous report from a contactable registered nurse (patient). A 57-year-old female nurse received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) injection at single dose via an unknown route in the left deltoid on 20Jan2021 for Covid-19 immunization. Medical history included hypothyroidism. Concomitant drug included ongoing levothyroxine sodium (EUTHYROX) started about 12 years ago as of 27Jan2021 at 75mcg once a day for hypothyroidism. Patient had first dose on the 20Jan2021, Wednesday and the last two nights (as of 27Jan2021) patient had chills. Onset date of chills was 25Jan2021. She assumed it would be sooner than further out close to the second one getting side effects. She also experienced weakness and was really really tired. Onset date of tired was 24Jan2021. She was unsure if she should get the second dose, or if she needs to contact her provider about this. She did not know if these are normal side effects or not. She looked at the side effect list, which said chills and headache, which she has experienced both. She also had dizziness. She used Flonase for the fluid in her ears. She thought the headache and dizziness was from fluid from pressure or something. The FLONASE helped with that. She had no fever. She was a week out from getting the dose and was wondering if she should still be having these side effects. Headache/ dizziness and weakness started a few days after she got the vaccine. She thought the weakness started that Friday or Saturday. If she got enough sleep she was okay, but she would wake up in the middle of the night. She thought the chills were from the weakness. She was also jittery and shaky as part of the weakness. Patient was always being really really tired later in the day. She thought that if she were working full time she would be missing work and that was medically significant. Treatment included FLONASE and took paracetamol (TYLENOL) for the headache early on. The events (chills, weakness, tired, headache and dizziness) were reported as serious with seriousness criteria of other medically important condition. No Investigation Assessment performed. Outcome of the events chills, weakness, tired was not resolved. Outcome of headache and dizziness was resolved. Outcome of the other evens was unknown.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-02-11 bell's palsy Patient diagnosed with Bells Palsy on 2/10/2021
57 2021-02-11 pain in extremity Unable to sleep all night, highly restless, tried to eat in the morning but vomited. Then only ate... Read more
Unable to sleep all night, highly restless, tried to eat in the morning but vomited. Then only ate a little and slept all day and night the next day. (Of course arm was sore too.)
57 2021-02-12 discomfort, weakness Within 2 hours: Headache, extreme fatigue (heaviness and weakness), rapid heart rate (98-134) at res... Read more
Within 2 hours: Headache, extreme fatigue (heaviness and weakness), rapid heart rate (98-134) at rest; joint pain added on day 2. This is still continuing.
57 2021-02-14 feeling cold Delayed adverse effects occurred about 8 hours after 2nd dose administered. Injection site tenderne... Read more
Delayed adverse effects occurred about 8 hours after 2nd dose administered. Injection site tenderness and bruising. Headache, chills, fatigue, achy joints, runny nose but no fever. Symptoms continued for 2 days after vaccine although not as severe by the 2nd day. Experienced nausea, dizziness or fogginess for 3-4 days after.
57 2021-02-14 hypersensitivity of all senses Allodynia, hyperalgesia, Universal joint pain, exaggerated symptoms of ongoing CRPS in all four extr... Read more
Allodynia, hyperalgesia, Universal joint pain, exaggerated symptoms of ongoing CRPS in all four extremities. Continued moderately severe pain almost 2 weeks out
57 2021-02-14 pain in extremity, weakness diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feelin... Read more
diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feeling; slept all day long/; poor appetite/No appetite; slept all day long/Had no energy; severe aches; woke up with 102° temperature; diagnosed with strep; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 57-years-old non-pregnant female patient (nurse) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), intramuscular in the left arm on 06Jan2021 at 16:30 as a single dose, Lot number Unknown for COVID-19 vaccination. The patient medical history was not reported. The patient has no know Allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE), alprazolam (XANAX). On 07-JAN-2021 at 12:00, the patient experienced diagnosed with Covid, sore arm, more tired/very fatigue, overall unwell feeling, slept all day long, poor appetite/no appetite, slept all day long/had no energy, severe aches, woke up with 102° temperature, diagnosed with strep. Adverse event start date was reported as 07JAN2021 at 12:00 PM However, the consumer reported the sequence of events as follows. Morning after the vaccination patients complaint was a sore arm. As the day proceeding, She became more tired. The following day was Friday. Very fatigue overall unwell feeling. On the weekend, Saturday and Sunday slept all day long. Had no energy. Very poor appetite. Once again overall unwell. Was able to work approximately half days on Monday Tuesday and Wednesday. She work Hospice and did enter a facility with known positive cases but was in Full PPE with every precaution as per my norm. On Thursday in the a.m. early she woke up with 102° temperature and severe aches. Was seen at the local urgent care and diagnosed with Covid. The adverse event result in Emergency Room Visit and Physician Office Visit The patient underwent lab tests and procedures which included body temperature of 102 on 07Jan2021 and ,SARS-CoV-2 test ( Nasal Swab) Positive on 14Jan2021. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Treatment received for the events were unknown but it was also reported 'she is on second round of antibiotics And steroids. Numerous exposures over last 10 month'. The clinical outcome of the events Covid-19, sore arm, more tired/Very fatigue, overall unwell feeling, Sleep excessive, poor appetite/No appetite, slept all day long/Had no energy, severe aches, fever was recovering; while Drug ineffective was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. ,
57 2021-02-14 pain in extremity, nerve injury Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain... Read more
Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain in shoulder went to the arms, back across to the front of the chest; dull aching pain; she didn't sleep; groggy; The pain in shoulder went to the arms, back across to the front of the chest; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK9231) (at the age of 57-years-old), via an unspecified route of administration on 20Jan2021 as a single dose for covid-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient medical history included acid reflux She has been good for last 2 months. She was on Pepcid but not anymore; uterine polyp removal in 2019 (reported as 2 years ago) polyps removed from uterine wall, it was done outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She does not know the name of the Anesthesia or have any Lot or Expiry; receives flu shot every year with no issue. The patient was not taking any concomitant medications. She has had No positive antibody or Covid test prior to the vaccine. She took the first shot last Wednesday 20Jan2021, she had a weird, not the usual reactions like she had read about. She even went to the Nurse Practitioner yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which is a good thing, but her question is does she take the second shot. The nerve damage started at 10 o clock that night causing shoulder pain, back pain, being lower back pain, because of it she didn't sleep, only 3 hour Thursday night. She's a teacher and even had to miss school on Friday. It is just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in shoulder went to the arms, back across to the front of the chest, she can follow with the hand here, its achy all on the left side. She went to the Nurse Practitioner and she said it sounds like nerve damage. The NP did not do any test, she really just left the office hoping that it would resolve on its own. Caller states that this is not going away. She actually read to not even take Tylenol or Advil 2 days prior as it can lessen the effectiveness of the vaccine. That's why she didn't take Tylenol till Friday Afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she can take Advil right now. The clinical outcome of the event: Low Back pain recovered; event Nerve damage was recovering; events achy all on the left side, Dull aching pain, shoulder pain, chest pain, Pain in arm, she didn't sleep, groggy unknown. She is scheduled for the second dose on 10Feb2021.
57 2021-02-15 weakness Temperature, chills, weakness and lethargy
57 2021-02-16 migraine Severe migraine pain for 2 days and on second day, severe swelling under the underarm on the right a... Read more
Severe migraine pain for 2 days and on second day, severe swelling under the underarm on the right arm.
57 2021-02-17 bell's palsy Bells Palsy
57 2021-02-17 numbness, tingling, pain in extremity, numbness and pain in extremities, difficulty speaking At 3:00 AM on 1/18/21 she was awoken from sleep with shoulder pain, hip girdle pain, long bones of t... Read more
At 3:00 AM on 1/18/21 she was awoken from sleep with shoulder pain, hip girdle pain, long bones of the thighs, could not raise arms above head, neuropathy of the palms, pain in wrist, tingling, numbness, stiffness of wrists, stiff fingers, hurt to bend fingers with pulsing capillaries. Started more centrally then extended down to extremities, did have some pain in ankles, neuropathy to the feet. Much worsening of the mucosal dryness of her eyes, mouth, lips, throat to the point that she was hoarse, and also her vaginal mucosa started to dry up as well. She took Acetaminophen, etc. She then was given some narcotics, which did not help the pain symptoms either. Her doctor had no answers, and did not prescribe her anything. Her eyes and throat dryness has waned somewhat. She is still having pain in her shoulder girdle. Does have the neuropathy pain, still hard to bend fingers. She had a very severe reaction this past weekend where she could not eat from Saturday to Wednesday due to nausea. She did get an order for Zofran on Monday, 2/15/21. She is still taking the Acetaminophen and Naprosyn, not taking the Norco due to constipation. Started taking her Synthroid again, but low dose. She is an RN and not able to work due to this condition. She also become leukopenic, her WBC's were lower than normal at 2.9, and her neutrophils dropped to a suboptimal level as well. She is now immunocompromised, and another reason for her not going to work as she works in an overflow unit for COVID patient's.
57 2021-02-17 tingling, pain in extremity, nerve pain R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; ... Read more
R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; decreased hearing to my R ear; The pain was worse in my R jaw- both upper and lower teeth pain; The pain was worse in my R jaw- both upper and lower teeth pain; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; decreased taste on the R side of my tongue; fatigue; muscle aches; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL 3248, Expiration date: Apr2021), via an unspecified route of administration at the left arm on 14Jan2021 08:15 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history includes shrimp allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was not reported. Historical vaccine includes 1st dose of bnt162b2 for COVID-19 immunization on 24Dec2020 09:30 AM, at the left arm, Lot number: EK9231 and Expiration date: Apr2021 at age of 57 years. The patient developed extreme fatigue, some muscle aches on 18Jan2021. She woke up with painful (pins and needle sensation) swollen hands. Took some TYLENOL and elevated them for a few hrs. The swelling subsided by the afternoon. On 19Jan2021, she developed R sided neck and facial swelling with nerve pain. The pain was worse in her R jaw- both upper and lower teeth pain, nerve pain extending from the side of my R ear up to my R eye and temple area. Feeling of heaviness to her R eye, R cheek, R side of her tongue, decreased hearing to her R ear (sounds muffled like being under water), decreased taste on the R side of heer tongue. Took benedryl and tylenol all day. On 20Jan2021, after a restless night due to the nerve pain (not relieved by tylenol) went to work but the swelling worsened so she was sent to the ED. They treated me with IV decadron, IV benedry, IV zofran- which immediately took away the swelling. The events result to Emergency Room/ Urgent Care Visit. Prior to vaccination the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient had Nasal Swab, PCR, covid test result was negative. The events were assessed as non-serious by the reporter, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
57 2021-02-18 migraine * ~10 pm on day vaccine given (Friday, 1/8/21), developed mild headache * Progressed to severe mig... Read more
* ~10 pm on day vaccine given (Friday, 1/8/21), developed mild headache * Progressed to severe migraine with some nausea during night, and lasted all day Saturday (~20 hrs.) I took Children's Tylenol dye free liquid late in day which took slight edge off headache. * Developed severe central chest pain in night, which felt like pain I experienced with esophagitis/gastritis in past. This lasted for about 20-30 minutes, then resolved. * Awoke next morning (Saturday, 1/9/21) with low grade fever (~99.3 degrees F), and had fever for 2 days (never exceeded 100.3 degrees F that I detected)--no appetite all day * Developed central low back pain/ache on Saturday ~ mid-day, which lasted through at least Sunday * Awoke Sunday morning with rash on torso (same rash familiar to me when I have infections--biopsied in past and determined to be interface dermatitis). Rash progressed throughout day to portion of arms, neck, groin (as always does with illness), and faded until resolving Monday am/mid-day. Itching then occurred over next couple of days (as it always does with illness). Appetite still limited. * Sunday evening experienced acute abdominal pain and urgent diarrhea x 3 or 4 episodes * Monday I felt better, but was fatigued and trying to get back on my feet
57 2021-02-18 pain in extremity After the first dose the next day strong pain in my left arm from the elbow to the wrist, Ceased the... Read more
After the first dose the next day strong pain in my left arm from the elbow to the wrist, Ceased the next day. After the second dose strong pain in the left side of my neck and back, mild pain in the injection site, malaise and muscular ache, all these symptoms improve the next day.
57 2021-02-18 pain in extremity Fever, chill, nausea, feeling sick , very sore arm
57 2021-02-19 weakness Shooting pain down entire arm and arm pit. Swelling of armpit, shoulder and elbow, loss of muscle s... Read more
Shooting pain down entire arm and arm pit. Swelling of armpit, shoulder and elbow, loss of muscle strength of entire arm. Inability to move arm. Symptoms continuously got worse for next 5 days. Pain started to decrease on February 6 and symptoms gradually improved over the following week.
57 2021-02-19 muscle spasms Sore at injection site, used rubbing alcohol. Felt better after a few rubs. Nausea, a few days after... Read more
Sore at injection site, used rubbing alcohol. Felt better after a few rubs. Nausea, a few days after, drank tea and honey. Came and left for a couple days Slight headache the next day, did not take anything. Meditation, Cramps in pelvic area, did stretches and yoga.
57 2021-02-21 cold sweat Rapid heart rate Burning through body Cold sweat Felt low blood pressure
57 2021-02-21 pain in extremity Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours,... Read more
Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours, Extreme fatigue-5 days, Chills-8 hours, Fever-3 days (reducing in severity each day), arm pain in shot area- mild and continuous for 6 days.
57 2021-02-22 weakness, involuntary muscle movements Three days after vaccine administration, patient indicates feeling weakness and involuntary movement... Read more
Three days after vaccine administration, patient indicates feeling weakness and involuntary movements in both legs.
57 2021-02-22 difficulty speaking Approximately 10 minutes after vaccination (during post vaccination observation), patient reported f... Read more
Approximately 10 minutes after vaccination (during post vaccination observation), patient reported feeling ?off? and that her throat hurt. I was contacted via radio to aid with assessment. Upon my arrival, patient reported that that she was experiencing slight difficulty swallowing, was feeling ?off? and felt ?like her head was in a fog?. Assessment of vitals revealed an intial vital signs of respiration rate of 18 breaths per minute, pulse of 74 beats per minute, 97% oxygen saturation levels. Blood pressure was obtained prior to arrival and was reported as 121/74. Lungs were clear to auscultation bilaterally. Clear S1 and S2 were present upon cardiac auscultation with no mumurs or gallops noted. Patient appeared slightly pale with a slightly hoarse voice. Patient did not have noticeable pharyngeal edema upon examination. Patiney had no increased work of breathing and was not using accessory Muscles for breathing. Patient was given a swallow test using bottled water and then solid food and demonstrated intact ability to swallow with no regurgitation, choking or drooling noted. Continuous oxygen saturation monitoring revealed 02 that never fell below 96%. Continuous pulse monitoring revealed a pulse that was between 74-79. Given the stability the vital signs, demonstrated ability to swallow and inappropriately labeled IM medication in emergency kit (ie three loose syringes were not drawn up by myself. Medications were labeled by hand with no expiration date, route or dose), I elected to give the patient 25 mg of oral diphenhydramine. Patient declined to seek emergency medical attention several times. Patient?s daughter was then called so that the patient could be driven home. Patient was advised to seek emergency medical attention if her symptoms worsened, she developed increased difficultly breathing or otherwise felt unwell. Advised to follow up with PCP within next 24 hours.
57 2021-02-23 weakness Weakness to left leg. Swelling to left armpit and left breast.
57 2021-02-23 muscle twitching Patient had second vaccination on 2/19, and later in the evening started to feel achy, and tired, an... Read more
Patient had second vaccination on 2/19, and later in the evening started to feel achy, and tired, and had swelling under arm, that is still there, though it has gone done. She satted it feels like it spread to her breast. She also stated she had a twitching on the side of her mouth that lasted a second. She denies, fever, SOB, chest pain, rash, or any other symptoms. She stated she is taking Tylenol every 6 hours which is helping. RN reviewed red flags to call 911. RN reviewed would folllow up tomorrow with her.
57 2021-02-23 pain in extremity, muscle spasms arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area... Read more
arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area (under collar bone); fatigued; chills; fever; body aches, it was more like body cramping; body aches, it was more like body cramping; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), intramuscular on the left deltoid, on 14Jan2021 07:15 at a single dose for COVID-19 immunization. The first dose was received on 28Dec2020 (lot number: EK9231), intramuscular on the left deltoid and patient experienced sore arm, and left upper (under collar bone) pain in her chest. The patient medical history was not reported. There were no concomitant medications. She received the vaccine around 7:15 in the morning and by midnight on 15Jan2021 (she works nights), she started to feel the pain. By that point, she was like "ooh, my arm is sore". She also started to have the same pain in her chest as she had before (pain in chest to her left upper sternal border area (under collar bone). Her doctor ordered a chest x-ray on 25Jan2021. Patient stated it was not cardiac. It's just there. The pain was annoying and she can feel it when she moves or when she goes to get up, it's an ache. Its a pain in the neck. On Friday, 15Jan2021, she was real fatigued, had chills, a little bit of a fever, and body aches. She clarified it was more like body cramping and her body hurt so bad. She over that by Sunday.All of her symptoms resolved by Sunday 17Jan2021, except for the pain she was experiencing in her chest which was still ongoing and persisting. She had taken Tylenol, Aleve, and Ibuprofen, but it doesn't resolve the pain at all. Outcome of the event of sore arm was unknown, for pain in chest was not recovered while for the remaining events was recovered on 17Jan2021.
57 2021-02-23 pain in extremity Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck,... Read more
Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck, its an aching pain, a nuisance type of pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the left deltoid on 28Dec2020 (07:15) at a single dose for COVID-19 immunization at the hospital. The had no relevant medical history and concomitant medications. On an unspecified date, after the first dose of vaccination, the patient had sore arm; pain in chest to her upper sternal border area (under the collar bone); and pain in the neck (further described as "an aching pain, a nuisance type of pain"). The patient had chest x-ray on 25Jan2021 (results were not provided). The patient had received paracetamol (TYLENOL), naproxen sodium (ALEVE) and ibuprofen as treatment for the reported events. The outcome of the events was not recovered for 'pain in chest to her upper sternal border area (under the collar bone)'; and was unknown for 'sore arm' and 'pain in the neck'. The patient had received the second dose of vaccination on 14Jan2021. The reporter believed that it was "highly coincidental" (pertaining to causality) considering the events happened with both vaccine doses. No further information was provided or obtained.
57 2021-02-24 discomfort, pain in extremity Sore arm within two hours. Some fatigue and slight headache and slight nausea within the first 24 ... Read more
Sore arm within two hours. Some fatigue and slight headache and slight nausea within the first 24 hours. All very minimal. Fever, chills, bad headache, sweats, general discomfort beginning around 24 hours after shot. Fever subsided 36 hours after shot. Headache persisted for over 48 hours. Some nausea between 48 hours and 72 hours after shot. Fatigue and haziness throughout.
57 2021-02-24 pain in extremity General fatigue, severe swelling in arm with pain, hives on scalp with horrible itching, diarrhea, s... Read more
General fatigue, severe swelling in arm with pain, hives on scalp with horrible itching, diarrhea, stomach pain, severe back pain, nausea.
57 2021-02-24 pain in extremity Severe leg and hip pain; Severe leg and hip pain; This is a spontaneous report from a contactable ot... Read more
Severe leg and hip pain; Severe leg and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 22Jan2021 09:00 (at the age of 57years) at single dose for Covid-19 immunization. Medical history included migraine. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ibuprofen (ADVIL), levothyroxine sodium (SYNTHROID), amitriptyline, rizatriptan benzoate (MAXALT), and butalbital, caffeine, paracetamol (FIORICET); all taken from an unspecified date for an unspecified indication. The patient previously took compazine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 06:00, the patient experienced severe leg and hip pain. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. This case is non-serious.
57 2021-02-24 cold extremities, hot flush 02/20/2021 Immediate post-vaccination onset of intermittent lightheadedness & migrating sensation of... Read more
02/20/2021 Immediate post-vaccination onset of intermittent lightheadedness & migrating sensation of tingling over body & face; at 45 minutes also experienced a sequence of coldness of feet, then hands (w/decreased perfusion), as those resolved then core/trunk, as trunk warmed then at 75 min upper gums, then eyelids, then nose; bowel urgency; at 2 hours warm flush, mind clearer, better color vision, feeling stronger; lightheadedness resolved within 3 hours of pharmacist observation. No urticaria, angioedema or respiratory distress. No treatment. Could stand and walk with assistance, though very fatigued. Rested at home. **Re-presentation of lightheadedness & tingling on 02/22 & again mildly on 02/24 while resting.**
57 2021-02-25 pain in extremity bad pain in the arm; pain in the arm like can barely move it; little soreness; This is a spontaneous... Read more
bad pain in the arm; pain in the arm like can barely move it; little soreness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262 and expiry date: unknown), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included breast cancer. Concomitant medication included letrozole. Patient received the vaccine on Saturday and last night on 25Jan2021 and the morning of 26Jan2021, patient was having a very bad pain in the arm like can barely move it. She was fine until last night. She had a little soreness on Saturday (23Jan2021) and the night of 25Jan2021 and the morning of 26Jan2021, she can barely lift it. The pain was really a lot and patient did not know if this was normal. She knew that there was supposed to be some soreness right afterwards but this was like a day and a half later. Patient took TYLENOL as treatment for the events. Outcome of the events was unknown.
57 2021-02-26 weakness, tremor 101 degree 48 hours after , generalized weakness, exacerbated hand tremors
57 2021-02-26 hot flush Nausea, hot flashes, cleared by medic
57 2021-02-27 weakness Three hours after vaccine, I started to get body aches, stiff neck and fatigue. Starting around 12 a... Read more
Three hours after vaccine, I started to get body aches, stiff neck and fatigue. Starting around 12 after vaccine I developed chills, headache, fever and extreme weakness which lasted for 10+ hrs. The weakness improved slightly, but continued. Starting 4 days after vaccine, I started to get stinging eyes, nose and mouth, increased nasal congestion and burning in my sinuses. These symptoms are debilitating and are the same ones I had when I was at my sickest with Covid. Whatever sense of smell or taste I had regained disappeared. These symptoms continues to the present.
57 2021-02-27 flushing A few minutes after receiving the vaccination, the patient complained of headache and flushing. Pat... Read more
A few minutes after receiving the vaccination, the patient complained of headache and flushing. Patient given Tylenol. Patient assessed by MD at chairside, after approximately 45 minutes, patient feeling better, headache subsiding. Discharged to home with spouse. Vitals stable.
57 2021-02-28 pain in extremity "57yoF requesting covid eval teacher, got 2nd covid vax 2/24 at 12:15pm, had ha started that night m... Read more
"57yoF requesting covid eval teacher, got 2nd covid vax 2/24 at 12:15pm, had ha started that night maybe 8 hrs later, fatigue also since 2/24 night and missed work 2/25 and 2/26. started feeling better fri 2/26 around 1pm. needs dr note to rtw or covid test. 1st vax asx other than little bit of arm pain."
57 2021-02-28 pain in extremity Arm pain x 3 days; fever for 48 hours, muscle/body pain x 48 hours; fatigue x 48 hours; severe heada... Read more
Arm pain x 3 days; fever for 48 hours, muscle/body pain x 48 hours; fatigue x 48 hours; severe headache has been on and off every day since the day of the injection, now 8 days in a row.
57 2021-03-01 pain in extremity Approximately 1 week post 1st vaccination became extremely fatigued, extreme sore throat at the sugg... Read more
Approximately 1 week post 1st vaccination became extremely fatigued, extreme sore throat at the suggestion of my doctor I got tested for mono. Came back positive on the afternoon of Jan 11, 2021 which coincidentally I had received my second vaccination that morning at 0900. I continued to have these same symptoms which worsened with extreme muscle pain especially in my legs, neck and lower back. Upon further lab work it was determined that I was in Rhabdo with my CK levels in 4,000, liver enzymes elevated, GFR low. By the way, this was a reactivation of mono that I had had as a child. I received over several days approx 10 liter of NS, zofran and toradol. To date, 3.2.2021, I remain easily fatigued by getting better. Lab work has all resolved to date.
57 2021-03-02 pain in extremity About 3am woke up with chills; headache; Arm was very sore.; Saturday, was very tired/lethargic/Felt... Read more
About 3am woke up with chills; headache; Arm was very sore.; Saturday, was very tired/lethargic/Felt blah all day, tired; out of breath; This 57- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on Jan2021 at 12:00 PM (at the age of 57-years-old) as a single dose for COVID-19 immunization, in right arm. The facility where COVID-19 vaccine was administered was at a Workplace clinic. She has had no other vaccines on the same day or in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included: allergy to pumpkin. Concomitant medication included: Osphena 60mg; VitD 2000IU; Vit C 1000mg; Zinc 50mg. Patient received dose 1 of Pfizer vaccine on a Friday at 12 noon. Felt fine all day. About 3am woke up with chills and a headache. Arm was very sore. Saturday, was very tired/lethargic all day. Slept 10 hrs, awoke with a headache (but no chills) and had breakfast, fell back asleep another 2 hrs, then another 2-hr nap early evening. Felt blah all day, tired and out of breath. Went to bed much earlier than normal. Felt good Sunday but arm still sore. It's Monday at 4pm and arm is still very sore to the touch. The clinical outcome of the events chills, headache, arm very sore, very tired/lethargic, out of breath were recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
57 2021-03-03 weakness extreme fatigue, mod headache and arm/ hand weakness that became worse as days went on. to point I... Read more
extreme fatigue, mod headache and arm/ hand weakness that became worse as days went on. to point I couldn't use my hands - severe weakness on various fingers (comes and goes) or lift my arms above my shoulders
57 2021-03-03 night sweats reports having soreness in left arm at site of injection site. developed loss of appetite that afte... Read more
reports having soreness in left arm at site of injection site. developed loss of appetite that afternoon after receiving vaccine. noticed shortness of breath while walking the dog. sunday evening, developed left axillary lymph node swelling. also with fever 99.8 - 100.2 degrees F. had night sweats saturday evening (2/27/2021 PM). also with headache after vaccine.
57 2021-03-03 tingling tingling all over, tingling lips. Evaluated by EMS-Cleared
57 2021-03-03 tenderness Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of... Read more
Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of skull just under hairline. Tender to touch. Limits mobility range (hard to turn head, tilt forward and back). Started with small 1m area Sunday night on 2/28 and has continued to grow. No fever. No pain anywhere else on body
57 2021-03-04 feeling hot Patient complained of "lightheadedness and feeling hot". Patient denied dizziness. Patient alert and... Read more
Patient complained of "lightheadedness and feeling hot". Patient denied dizziness. Patient alert and oriented. Patient denies chest pain, SOB, rash, and itchiness. Patient provided with ice pack. Blood pressure 128/88, respiratory rate 16, and temperature 97.4F. Symptoms subsided at 1530 with ice pack, rest, and relaxing measures.
57 2021-03-05 speech disorder I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble sw... Read more
I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble swallowing. Fever escalated to 103 at 1am 3/3. By 9am 3/3 neck was much more swollen and swallowing more difficult. By 3/4 fever down to 101.3 but throat so swollen difficult to talk, drink, unable to eat. Went to ER at 3:30pm 3/4.
57 2021-03-06 tremor, burning sensation, flushing Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left delt... Read more
Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left deltoid and, was escorted to the 15 minute observation area. She noted feeling burning sensation in her chest and bilateral arms after a few minutes. Patient brought to EMS for evaluation. EMS obtained several sets of vital signs, notable for hypertension (170's/90's). Patient placed on stretcher. She was flushed, had a dry/thick tongue, developed rash on bilateral arms, began shaking and shivering but stated she was not cold only nervous. She was given 50 mg benadryl IM, 18 g IV started in her right antecubital. She declined solumedrol due to past experience with steroids. Her flushing and rash began to resolve, patient stated her tongue felt better. Patient was transported by EMS for evaluation. She had her phone with her, but her husband took her other belongings and will meet her there.
57 2021-03-07 inability to speak Stated often has panic attacks when receives shots or has IVs placed. Stated after vaccination, tong... Read more
Stated often has panic attacks when receives shots or has IVs placed. Stated after vaccination, tongue started to feel bigger and to itch at the back, throat also started to feel tight. Monitored by EMTs in parking lot. Given oral Benadyl. Was not transported to hospital. Husband came to pick her up. Stated a few hours later felt pressure in windpipe at level of clavicles & had difficulty breathing. Stated sleep the rest of the day. Denies HA, fever, or chills. Stated throat felt better the next day though still feels pressure at base of throat. Also complaining of occasional "brain zap" (zing in brain that then causes eye to twitch). States that since tongue started feeling big she has had trouble talking--words coming out funny. States that is still happening.
57 2021-03-07 weakness I became sluggish at first, then just wanted to sleep, woke up and all my muscles in my body seemed ... Read more
I became sluggish at first, then just wanted to sleep, woke up and all my muscles in my body seemed to be on fire. Pain was quite intense. I would say on scale of 1-10 a 10. Felt like a very bad case of my Crohns coming on. I took Tylenol for pain relief every 4-6 hours. From Friday evening through Saturday March the 6th I had no appetite did not have strength to hardly leave the bed. I had some stomach cramping and diarrhea on morning of March 6th. I slept and off for close to 38 hours. I could not make a fist with my left hand at all and had very little strength in my right side. I ran a slight fever of 99.My head was splitting. My husband had the vaccine on March 2nd and he had only slight discomfort and weakness for about 16 hours. Said he felt like he had a hangover. I was expecting some type of reaction but decided Saturday evening if I got any worse I would go to urgent care. I slept about 5 solid hours on March 6/7 and awoke Sunday morning feeling somewhat better. Pain was at about a 5. Today March 8, 2021 I am feeling better, just weak, still no appetite, headache has eased and I can grip both left and right hand now. I am better today than yesterday. I will continue to monitor myself. With my history of Crohn's I am very aware of body and how it reacts. My normal is not everyone's normal, but want to make you aware of how miserable I was. I am thankful I received and pray that his helps me to not get Covid. If you have further questions, please do not hesitate to contact me.
57 2021-03-07 numbness Numbness/tingling in both checks, lips, tip of tongue approximately 30 mins after vaccine, improved... Read more
Numbness/tingling in both checks, lips, tip of tongue approximately 30 mins after vaccine, improved with Benadryl 50 mg, similar symptoms 4 hours later which again improved with Benadryl
57 2021-03-07 tingling first dose vaccine given at a blitz immunization event pt complained of non-specific tingling sensa... Read more
first dose vaccine given at a blitz immunization event pt complained of non-specific tingling sensation mid face after receiving pfizer covid vaccine denied lip/tongue swelling, rash/urticaria, wheezing, sob, cp, cough observed for total of 30 minutes no abnormal clinical findings present pt received 12.5mg po benadryl discharged from blitz event with instructions to seek medical attention if sx's worsen or persist - pt was not sent to the ER
57 2021-03-07 seizure Passed out within 10 minutes of getting the shot Went into a seizure An EpiPen was administered with... Read more
Passed out within 10 minutes of getting the shot Went into a seizure An EpiPen was administered within a few minutes Transported to the hospital via ambulance and monitored at the hospital for about an hour after that.
57 2021-03-07 seizure 0900 PT arrived on site, expressed that she had a recent mild reaction to PEG during a recent colono... Read more
0900 PT arrived on site, expressed that she had a recent mild reaction to PEG during a recent colonoscopy. States that she broke out with hives on her face and arms. PT was administered 0.5ml of benedryl prior to administration of vaccination and had her wait 10 min for medicine to take effect. 0913 PT was administered 0.3ml of Pfizer COVID vaccine. 0922 PT's started to show signs of distress with heavy breathing. Upon first contact with PT she was speaking with labored breathing. 0924 PT started to seize. Dr. attempted to communicate with PT and reclined her car seat gain better access. 0925 EMS was called 0925 Epi Pen was administered (successfully) PT started to communicated again but started to feel light headed and nauseous and was returned to a sitting position. RN had taken over and was assisting with PT care. 0938 Paramedics arrived on scene 1005 Paramedics cleared scene and transported PT to ER.
57 2021-03-08 hypersensitivity of all senses Body aches. Joint pain. Fever. Chills. headache. Skin sensitivity. Thirst. Started about 7:00 pm an... Read more
Body aches. Joint pain. Fever. Chills. headache. Skin sensitivity. Thirst. Started about 7:00 pm and pain and symptoms lasted about 24 hrs
57 2021-03-08 numbness on the 7th, started experiencing grogginess and gassy stomach. next day on the 8th, symptoms worsene... Read more
on the 7th, started experiencing grogginess and gassy stomach. next day on the 8th, symptoms worsened and began to feel dizziness. severe numbness on the right side of her body. right arm/right leg, trouble with breathing and cannot perform daily activities
57 2021-03-08 pain in extremity Left arm pain, chills, body aches, fever, fatigue
57 2021-03-08 tingling, burning sensation hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, ... Read more
hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, dx of Epigastric abdominal pain, vomiting 48 hours, dr visit, hospital visit for dehydration, lack of smell and taste, tingly limbs gone but severe pain behind right knee, ruled out blood clot, smell back, taste not all the way returned, pain continuous
57 2021-03-08 slow speech According to onsite fire company client symptoms, 8:38 am-alert to name but couldn't recall year and... Read more
According to onsite fire company client symptoms, 8:38 am-alert to name but couldn't recall year and date, confused, slow to react, slow speech, dilated pupils. 8:40 am-BP 145/78, pulse 78, O2 Sat 97%,. 8:42 am-Client verbalized feeling nauseous and dizzy but she was okay, pupils semi dilated, able to follow command. 8:43 am-Per paramedic client needs further evaluation. 8:45 am-BP 142/80, pulse 79, O2 sat 100%, Blood glucose 79. 9:01 am-rescue crew arrived on scene. 9:08 am-Client transfer to hospital for further evaluation due to in and out periods of confusion.
57 2021-03-09 tingling Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild,... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient did not have any anaphylaxis, main complaint was mild tightness under chin between jaw and lymph nodes 20 minutes post immunization lasting for a max of 30 minutes. Also mild tingling in forearm a few minutes after injection.
57 2021-03-09 tingling Patient reported tingly face within 3 minutes of vaccine. Gave pt 50mg diphenhydramine and monitored... Read more
Patient reported tingly face within 3 minutes of vaccine. Gave pt 50mg diphenhydramine and monitored for 30 minutes. No worsening symptoms/signs. Patient left to return to work. Contacted patient at 1:30 to check up. She face was still tingly but less than before. She was tired.
57 2021-03-09 tingling tinging to hand distal to injection site. No rash, sob, throat swelling
57 2021-03-09 tingling tingling to left arm distal to injection site
57 2021-03-09 tremor Approx 5 minutes after I received the IM injection I developed SOB, Heart rate was in the 160's, b/... Read more
Approx 5 minutes after I received the IM injection I developed SOB, Heart rate was in the 160's, b/p-158/90. I was lightheaded and thought I was going to pass out. My blood pressure has never been that high. Nor have I ever had a HR like that. My body was shaking so much that I couldn't hold on to the water bottle they gave me( d/t developing a very dry mouth.) This lasted about 8 min and then my HR started to go back down.
57 2021-03-10 weakness, nerve pain, burning sensation brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; ex... Read more
brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; extreme burning in her lower extremities and hands; nerve pain 9 out of 10; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ON5318), via an unspecified route of administration in the left arm on 08Feb2021 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient has been having a lot of side effects. The patient experienced common weakness on 09Feb2021 which was expected, extreme burning in her lower extremities and hands but it was worse in her lower extremities which occurred 4-7 days after vaccination in Feb2021, orthostatic hypotension and dizziness on 12Feb2021, nerve pain 9 out of 10 in Feb2021 which has subsided as of 20Feb2021 or 21Feb2021, super weak, brain fog and sleepy on unknown date. As of 24Feb2021, patient still had orthostatic hypotension and weakness. Stated they have done a CBC on her and everything looks good, her basophils are a little elevated but it is nothing serious. The patient is concerned about the second dose, does not think patient is going to get it. Outcome of events weakness, orthostatic hypotension and dizziness was not recovered, events extreme burning in her lower extremities and hands and nerve pain 9 out of 10 was recovered in Feb2021. Outcome of other events was unknown.; Sender's Comments: The causal association between the reported event nerve pain which was 9 out of 10 according to the patient and the BNT162B2 COVID-19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
57 2021-03-10 cold sweat, flushing Cold sweat, flushing, evaluated by EMS, patient refused transport.
57 2021-03-11 feeling hot During observation felt hot and sweating No LOC vision blurred Responded to lying down and fluids di... Read more
During observation felt hot and sweating No LOC vision blurred Responded to lying down and fluids discharged home with daughter
57 2021-03-11 feeling hot Approximately 10 minutes post Pfizer 1st dose vaccination patient began to complain of dizziness. Pa... Read more
Approximately 10 minutes post Pfizer 1st dose vaccination patient began to complain of dizziness. Patient walked on own to stretcher and was assisted to lay down. Vital signs were assessed 158/72 70 18 99 % RA. Patient stated dizziness was continuing and she was feeling like she had an "out of body experience" she noted she feels strange like she was floating. She also reported feeling a sensation of warmth through her body which was concentrated from her knees down. Patient began dry heaves and stated she feels like she felt when she had chemo. After 20 minutes of observation the patient's symptoms were not improving. The patient stated she was genetically tested at the medical center due to her body's response to certain medications and she stated she was concerned due to her reaction to the vaccine. She never became short of breath and did not have itching. Her dry heaves subsided quickly and she did not have any nausea.
57 2021-03-12 feeling hot, tingling As soon as I received the vaccine , I felt the same as if I were stung by a bee. I felt warm and I... Read more
As soon as I received the vaccine , I felt the same as if I were stung by a bee. I felt warm and I could feel my tongue getting numb. I told the pharmacist & after about 15 minutes I asked if I could take my Benadryl. So it sort of slowed it down but I still had the tingling and numbing . It?s been 3 days and I?m still experiencing the numbing of my tongue .
57 2021-03-12 feeling hot I observed patient fanning herself with a piece of paper. Patient reports feeling lightheaded, hot a... Read more
I observed patient fanning herself with a piece of paper. Patient reports feeling lightheaded, hot and nauseous. Wheeled patient to private area. Vital signs at 1612 were BP 113/62, P 81, R 20, O2 99% on RA. Patient removed mask and drank water. After 15 minutes patient reported feeling back to baseline and daughter wheeled patient to the car.
57 2021-03-12 pain in extremity Fever from 99.6-101.8 with chills and aches 3/8/2021-3/11/2021. Sore arm and unexplained diverticul... Read more
Fever from 99.6-101.8 with chills and aches 3/8/2021-3/11/2021. Sore arm and unexplained diverticulitis flare up 3/6-3/8. Not sure flare up related to vaccine.
57 2021-03-13 pain in extremity Pain and inflammation in hand previously broken (which had been pain-free).
57 2021-03-13 pain in extremity arm very sore initially, and very HEAVY, but that passed within 24 -48 hours. However, soreness has ... Read more
arm very sore initially, and very HEAVY, but that passed within 24 -48 hours. However, soreness has now returned to the left arm.
57 2021-03-14 feeling hot, migraine, flushing 11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizzin... Read more
11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizziness, she denied any SOB or breathing difficulty. Assisted Pt. back to sitting in chair. 11:50 AM ? Client states she had her vaccine at 11:20 AM and stayed for 30 min at which time she started to experience the numbness and tingling of lips. B/P 150/70, Pt had own O2 Sat monitor which included pulse, O2 sat was 96%, pulse 92, no respiratory distress noted. 11:51 AM- 12.5mg Benadryl given P.O. Pt states she gets very tired with ?full dose?. Pt states she is ?queasy?, light-headed, dizzy and has vasovagal responses to vaccines. She carries an Epi-pen for various food allergies, an O2 sat monitor and emesis bags in case she has a vagal response which she states this is what she feels like. 12:00 PM ? B/P 156/90, HR ? 92, O2 sat 97%, RR ? 20, No swelling, redness or irritation at Right Deltoid injection site. 12:06 ? Pt denies any dizziness or lightheadedness at this time but continues with tingling at lips and thick front of tongue, numbness B/P 152/92, HR 76, o2 sat 95%, RR- 20, cool cloth applied to back of neck, lower legs elevated on chair. Pt wearing compression hose. 12:20 PM ? Consult with Pharmacist who stated another dose of Benadryl would not be recommended and suggested lying down on stretcher and possible anxiety reaction. Pt refuses to lie down on stretcher and states is fine sitting with legs elevated. 12:24 PM B/P 146/90, P ? 64, RR ? 20, O2 sat 97%, Pt has flushed face and states her cheeks feel tight. She states she has Rosecea but her cheeks aren?t usually very flushed. She c/o warmth on cheeks and numbness in front area of tongue. No difficulties noted with swallowing water. Daughter arrived. Site director consulted to determine next steps and decision made to transfer to ED. Discussed transfer to ED with pt who verbalized agreement. 12:34 PM Pt states dizziness resolved however she now has a H/A and possible onset of a migraine. 12:35 PM B/P 162/90 P- 80, RR-20, O2 sat 98%. Pt denies any respiratory distress, refuses food due to many food allergies. Continues to tolerate water without swallowing difficulty or emesis. 12:40 PM Assisted Pt to wheelchair and transferred to Emergency Department for further evaluation and observation. Dtr present and verbal report given to ED RN.
57 2021-03-14 flushing, inability to speak Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives... Read more
Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives noted on chest, ears itching, no respiratory symptoms or difficulty. Speech clear, no stridor noted. Pt stated does have a significant allergy history and sees an allergist. Medicated with Benadryl 50 mg po and immediately to ED, registered right away, pt then c/o head and back itching, and taken into triage for assessment by triage nurse. Per Hospital Note: Patient initially developed hives and itching with progression in symptoms to include shortness of breath and throat tightening. She reported feeling as though her tongue were swelling and having difficulty speaking and having difficulty swallowing. Concerns of impending loss of airway prompted administration of IV Solu-Medrol, Benadryl and 2 doses of intramuscular epinephrine which were unsuccessful and therefore emergent intubation was performed. Patient apparently has had prior anaphylactoid reactions in the past including bee stings and shellfish.
57 2021-03-14 pain in extremity felt tired; Headache; arm was sore; This is a spontaneous report from a contactable consumer. A 57-... Read more
felt tired; Headache; arm was sore; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL0140, expiry date Mar2021), on 12Jan2021 12:00 in the left arm at a single dose as COVID-19 vaccine. Medical history included ongoing COVID-19 from 12Jan2021; and mold allergy, pollen allergy, bleach allergy, and lactose (intolerance), all from an unknown date and unknown if ongoing. There were no concomitant medications reported as no other products that were taken together with the COVID vaccine. The first dose of bnt162b2 for COVID-19 immunization was given on an unknown date and was tested positive at work (12Jan2021) and had the nose swab in 12Jan2021 (reported as yesterday) at her job. Patient he had the second dose of the shot (vaccine) on12Jan2021 (reported as yesterday); and all was like she felt tired in the morning of 14Jan2021, and on 13Jan2021 had headache and her arm was sore, other than that she felt she was fine. She didn't have any chills or anything and they said she was tested positive. She did the nose swab that they did at the nursing home. Patient asked that she has gotten the reaction to this, does it mean that she has Covid or not. Before second dose, patient confirmed that she was tested positive with the nose swab test then she received the second dose, and she was then sent home. It was confirmed that the issues occurred after use of a Pfizer product. No admission to hospital involved and no treatment received in response to the events. The events recovered on an unspecified date in 2021.
57 2021-03-14 pain in extremity Vaccination burned slightly, some arm soreness, but no other immediate reactions. Eight days after ... Read more
Vaccination burned slightly, some arm soreness, but no other immediate reactions. Eight days after vaccination I developed skin tenderness on L forearm. Days 9-13 have resulted in rash in several areas on forearm and additional tenderness on upper arm. At regularly scheduled dermatologist appt they advised it was shingles and prescribed an anti-viral medication (Valcyte HCL 1000mg).
57 2021-03-15 night sweats Headache, Myalgia, Arthralgia, Fever, fatigue, night sweats, throbbing pain at the injection site. N... Read more
Headache, Myalgia, Arthralgia, Fever, fatigue, night sweats, throbbing pain at the injection site. Narrative:
57 2021-03-16 numbness Had tingling in the tongue and numbness in right side pf the face, around eyelid, down the cheek and... Read more
Had tingling in the tongue and numbness in right side pf the face, around eyelid, down the cheek and to side of the nose. It lasted until I went to bed. Symptoms had disappeared by the time I woke up the next day
57 2021-03-16 pain in extremity Fatigued; Arm sore; Irritable; This is a spontaneous report from a non-contactable Other Health Prof... Read more
Fatigued; Arm sore; Irritable; This is a spontaneous report from a non-contactable Other Health Professional (the patient). A non-pregnant 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249), via an unspecified route of administration, in the left arm on 09Feb2021 at 11:30 AM (at the age of 57 years) as a single dose for COVID-19 immunization. Medical history included covid-19, prior to vaccination. The patient did not have any known allergies to medications, food, or other products. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Feb2021, the patient experienced fatigued, arm sore, irritable. Therapeutic measures were taken as a result of fatigued, arm sore, irritable, which included 2 Tylenol. The clinical outcome of the events fatigued, arm sore, irritable was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
57 2021-03-16 pain in extremity Tinnitus left ear has not stopped since vaccine. Severe chest pains and heart pounding for 2 days af... Read more
Tinnitus left ear has not stopped since vaccine. Severe chest pains and heart pounding for 2 days after vaccine. Pain in right leg calf muscle
57 2021-03-16 pain in extremity My entire left arm has been stiff and sore ever since injection. Pain has traveled from injection si... Read more
My entire left arm has been stiff and sore ever since injection. Pain has traveled from injection site down to my fingertips. Weeks later I am in moderate pain.
57 2021-03-16 pain in extremity Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told ... Read more
Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told me that this was acute thyroiditis. My heart rate was very high (122 bpm) when I visited my doctor's office and it was 130 bpm when I was triaged in the Emergency Room. Upon my doctor's advice, I went to the ER in the afternoon of 03/12/2021 where I was further tested. I was given medications to counteract inflammation, nausea and headache. In addition, I was given medication (beta blocker) to lower my heart rate. When my blood pressure was taken after a couple of hours, the readings revealed that my pressure had also started to fall. I spent overnight in the telemetry unit of the ER - I was given 2 liters of IV fluids to stabilize my vitals. The following day (03/13/2021), I met with endocrinologists who told me to what extent my thyroids were affected and what further medications to take. I had told them and other ER doctors as to what precipitated all of this. I was given anti inflammatory medication and a beta blocker that day before I was discharged in the evening. I have no history of thyroid issues or heart issues. I do not suffer from any chronic illness. I was not sick before I took the second dose of the vaccine. I started to feel ill within 5 hours of taking the vaccine shot, and the symptoms worsened over nearly the following two weeks. Now, following medical intervention, I am continuing treatment with various medications. I don't feel well yet, and I understand that the process towards recovery is going to be slow and unpredictable. I wanted to report this, since I feel that scientists and researchers should have this knowledge that thyroiditis can happen as an adverse reaction to the COVID-19 vaccine (Pfizer/BioNTech).
57 2021-03-17 bell's palsy Bell?s Palsy
57 2021-03-17 facial paralysis, numbness Left side face drooping , worsening numbness in hands (lasted from afternoon of vaccine until next ... Read more
Left side face drooping , worsening numbness in hands (lasted from afternoon of vaccine until next morning)
57 2021-03-17 grand mal seizure, seizure Recipient with history of epilepsy induced by stress started seizing approximately 5-6 minutes after... Read more
Recipient with history of epilepsy induced by stress started seizing approximately 5-6 minutes after receiving her vaccine. Before onset of first seizure pt reported throat tightness and had a mild dry cough. Dr. (Med eval) evaluated patient- lung sounds clear, pulse strong and steady 92 bpm, heart sounds normal. Pt reported that she felt like she was going to seize. Generalized tonic clonic seizure lasting approximately 1 minute. Post ictal period noted with minimal responsiveness but good color and respirations x 1 minute. Second seizure lasted approximately 1 minute, again generalized tonic-clonic with good color and respirations. Post ictal for approximately 3-4 minutes. Pt was transfered from car to stretcher. Sats 97% on room air. lung sounds clear with good respirations. 3rd generalized tonic clonic seizure ensued (lasting approximately 1 minute). EMS gave 5mg IM midazolam in her right deltoid. Transfered into ambulance, 3 lead EKG reviewed by Med Eval and no acute findings were noted. Recipient transferred to emergency department.
57 2021-03-18 weakness Low grade fever, chills, headache, nausea, body aches, lack of energy, lack of appetite
57 2021-03-18 cold extremities 3-17-21 6:30PM 'LT ARM FEELS COLD'. LT ARM IS SLIGHTLY COOLER THAN RT ARM TO TOUCH. GOOD CAP REFIL... Read more
3-17-21 6:30PM 'LT ARM FEELS COLD'. LT ARM IS SLIGHTLY COOLER THAN RT ARM TO TOUCH. GOOD CAP REFILL. NO NEURO OR MOTOR DEFICIT. AMBULATORY TO EXIT WITHOUT ANY ACUTE DISTRESS. 3-19-21 8:50AM TC: 'LT ARM FEELS FINE NOW'.
57 2021-03-18 tremor SEVERE headache and nausea. Chills, shakiness, fatigue
57 2021-03-18 tremor Tachycardia (124), lightheaded, tremulous, dysphagia. Premedicated with Allegra 180mg PO(9.45am). P... Read more
Tachycardia (124), lightheaded, tremulous, dysphagia. Premedicated with Allegra 180mg PO(9.45am). Pepcid 20mg PO(1.30pm)., Tylenol 1g PO (1.56pm). Observation for 1hr, HR reduced to 92. Able to drink and swallow meds. HA & lightheadedness resolved and mild dysphagia, HR 82 at 3.13pm.
57 2021-03-19 difficulty speaking Patient complained about SOB, stridor and feeling of airway obstruction. Patient said she took her A... Read more
Patient complained about SOB, stridor and feeling of airway obstruction. Patient said she took her Albuterol inhaler right after she started feeling the SOB. Called 911 and arrived @ 1455. Noticed diminished voice when patient when talking, and directly administered 1st dose EpiPen @ 1446. Called for assistance, and EOA arrived @ 1447. BP taken @ 1447 156/100 with O2 sat 98%. Patient condition was not improving and per EOA, 2nd dose of EpiPen was given @ 1454. Took 2nd set of VS @ 1454 right after EpiPen administered BP 130/100 O2 sat 99. Patient stated of feeling better and noticed patient voice coming back to normal. AMR assessed patient. However, patient denied transportation to hospital stating to the AMR that she feels much better and her voice is coming back. AMR left and recommended patient to stay for an extra 30 min for monitoring. Patient finally left at 1540 with her partner, stable and walk steadily.
57 2021-03-20 hot flush, weakness lymph node under left arm down to the left breast was swollen and painful; body aches; weak; lymph n... Read more
lymph node under left arm down to the left breast was swollen and painful; body aches; weak; lymph node under left arm down to the left breast was swollen and painful; temp of 99.4 to 99.9; chills; joints ached; fatigued; With in 3 hours of injection, I got hot and flushed in my face; This is a spontaneous report from a contactable nurse (patient). A 57-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not available) via intramuscular on right arm on 13Jan2021 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation at Workplace clinic. The patient's medical history included Asthma and Arthritis. The patient had allergies to medications, food, or other products (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Historical vaccine included first dose of influenza vaccine at the age of 57 years in nasal on 02Dec2020 which was given within 4 weeks prior to the COVID vaccine and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown via intramuscular on left arm on 23Dec2020 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation. On 13Jan2021 at 17:00 (05:00 PM), within 3 hours of injection, the patient got hot and flushed in her face. The next morning on 14Jan2021, she woke up and her lymph node under left arm down to the left breast was swollen and painful. The patient also had a temperature of 99.4 to 99.9 and had chills and body aches enough to keep her home from work. The patient had joints ache and felt weak and fatigued. This lasted for about twenty-four hours. The reporter assessed the events as non-serious. The outcome of the events was recovered in Jan 2021. Information regarding lot/batch number has been requested.
57 2021-03-20 pain in extremity I had a sore arm and a headache for 24 hrs. after receiving the vaccine, but otherwise fine. Three ... Read more
I had a sore arm and a headache for 24 hrs. after receiving the vaccine, but otherwise fine. Three and a half days after receiving the vaccine, I woke up in the middle of the night, very dizzy. The room was spinning. Spent the next three days in bed with chronic fatigue, chills (but no fever), and VERTIGO. It has now been over a week since my vaccine, and I am still experiencing joint pain and dizziness every time I stand up or lie down.
57 2021-03-20 tingling Five minutes after receiving the vaccination on her left deltoid, she developed tingling over her le... Read more
Five minutes after receiving the vaccination on her left deltoid, she developed tingling over her left arm as well as her left lower s and her left hand, primarily over the dorsum of the second through fifth digits. Denies any shortness of breath, itching, counseling, facial swelling, no evidence of anaphylaxis.
57 2021-03-21 involuntary muscle movements About 10 to 15 minutes after receiving vaccine patient complained of tightness in the chest. After a... Read more
About 10 to 15 minutes after receiving vaccine patient complained of tightness in the chest. After a short time she experienced tingling in lips. We moved her to the floor and laid her flat with head raised as she began to experience uncontrolled movements in arms and legs (seizures?) I administered epinephrine for tightness in chest and tingling lips and 911 was called. Rescue squad arrived stabilized her and transported to hospital.
57 2021-03-21 difficulty speaking 21Mar2021, At 1820, 20 min post injection, allergic reaction including throat and chest tightness, w... Read more
21Mar2021, At 1820, 20 min post injection, allergic reaction including throat and chest tightness, wheezing, voice became barely audible. Coughing. At 1830, 30 min post injection, EMTs administered IM epinepherine, 25 mg IV Benadryl, 1 albuterol neb. At 1851 on ER arrival, BP 206/87, pulse 95, resp 18, temp 97.5 F, SpO2 99%. At 1913, attending physician administered solumedrol 125 mg. At 1755, blood drawn for total complement, CH50, and tryptase At 2240 improved, stable, discharged from ER with instructions to take 50 mg oral prednisone for next two mornings and follow up with primary care physician as necessary
57 2021-03-21 muscle spasms 57y/o female presents with mild throat tightness ~15min after receiving Pfizer vaccine into the left... Read more
57y/o female presents with mild throat tightness ~15min after receiving Pfizer vaccine into the left arm. She states that it feels as though something small got stuck in her throat and is causing mild discomfort. She reports associated injection site pain, body cramps, and headache. She denies itching, difficulty breathing, shortness of breath, chest pain, palpitations, blurry vision, presyncope, difficulty swallowing water, or lip/tongue swelling. She reports no change in symptoms after 40min. post-injection. Physical Exam: Heart Rate 66bpm, Blood Pressure 115/74, Repeat Blood Pressure at 40min post-injection 120/80 Cardiac: regular rate and rhythm Lungs: unlabored breathing, clear to auscultation bilaterally Skin: no injection site erythema or swelling. No rash. No lip/tongue swelling or narrowing of oropharynx. Plan: Patient reports that her symptoms have improved at 1hr post-injection and would like to leave. I advised her that she should wait until all of her symptoms have resolved as throat tightness is a concerning adverse reaction. I provided her with options including contacting EMS right now to take her for observation at the hospital, however, the patient declined and said she would not go in the ambulance. She insisted that she wanted to go home and that her husband was driving and would take her to the emergency room if her symptoms worsen. Patient was well-appearing when she left the vaccination site.
57 2021-03-21 muscle twitching I developed a non stop under eye twitch on my left eye 2 days post vaccine. Today is 6 days later a... Read more
I developed a non stop under eye twitch on my left eye 2 days post vaccine. Today is 6 days later and it's still twitching. I also feel extra fatigue.
57 2021-03-21 pain in extremity, numbness Right arm pain and numbness, shoulder, both back area on right side and pain and chest heaviness. ... Read more
Right arm pain and numbness, shoulder, both back area on right side and pain and chest heaviness. Shortness of breath. Pain when trying to take deep breath. The shoulder, chest and back pain was unbearable for seven days
57 2021-03-21 pain in extremity Ringing in the ears (both), began within hours of my second dose and still happening 4 days later Le... Read more
Ringing in the ears (both), began within hours of my second dose and still happening 4 days later Legs ached the day of the shot and the day after but ok now
57 2021-03-22 weakness Dizziness, faint, weak. Patient drank 2 bottles of water. BG 299, BP 129/86, RR 14, 99% room air.
57 2021-03-22 burning sensation 4 days after vaccination, burning, itching right middle back and front torso, transient burning patc... Read more
4 days after vaccination, burning, itching right middle back and front torso, transient burning patches on left thigh at top and top of left foot: side of neck and ear
57 2021-03-22 numbness, pain in extremity, tingling Felt fine, no pain in right arm where vaccine was injected. Next day around 2pm felt muscle pain in ... Read more
Felt fine, no pain in right arm where vaccine was injected. Next day around 2pm felt muscle pain in lower part of left arm and right leg, thought it was just muscle pain like the flu. My arm and leg started tingling and going numb, would wake me up at night. Had a Dr. appt. on March 18 when I mentioned I had numbness and tingling, but thought it was just side effect from the injection. Saturday, March 20 called 811 and nurse recommended I get it checked out. Monday, March 22 called my Dr. office, but no openings. Started noticed tingling and numbness is left leg as well. March 23 went to ER regarding my concerns. Dr. checked me and said to keep an eye on my symptoms; GBS was brought up and he said it could show in up to six weeks.
57 2021-03-22 muscle spasms Headache, Myalgia, Diarrhea, Nausea Vomiting, UPPER LIP TINGLING, METTALIC TASTE, CRAMPS, CHILLS
57 2021-03-22 tingling Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported tin... Read more
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported tingling in arms and lips burning/numb, no difficulty breathing was monitored in store for 1 hour, no epipen needed, advised to take benadryl
57 2021-03-23 weakness, unresponsive to stimuli, discomfort Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: F... Read more
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild
57 2021-03-23 weakness Pfizer-BioNTech COVID-19 Vaccine EUA Debilitating Exhaustion/Fatigue loss of appetite symptoms pres... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Debilitating Exhaustion/Fatigue loss of appetite symptoms presented 16 hours after 2nd dose and continued for 48 hours.
57 2021-03-23 difficulty speaking Horseness, SOB and itching
57 2021-03-23 flushing, unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient lost consciousness for ~1 minute, around 5 minutes after receiving first dose of Pfizer COVID-19 shot. Patient was spotted by other patients in waiting area and nearby technician immediately. Breathing never stopped, no epinephine/benadryl administered. Patient was sweating and was provided water. As soon as she regained consciousness, she was able to recite her name and DOB. 911 was called and paramedics arrived within 5 minutes. Taken by EMS to ER.
57 2021-03-23 numbness Tingling in lower lip and numb feeling on left side of face approximately 30 min (5:40pm) after vac... Read more
Tingling in lower lip and numb feeling on left side of face approximately 30 min (5:40pm) after vaccine. Within 1 hour the feeling was almost gone. Next few days left lower side of face still felt different. 10:00 pm (29 hours after vaccine) started with chills and body aches. Next morning 6:00am was very tired and felt the same. Took 2 Ibuprofen. Dozed on and off in morning. Felt better in afternoon. Around 6pm started feeling chills and achy. Took 2 more ibuprofen. Arm was sore. Next morning, had to work. Felt tired and brain fog all day. Slight achy. Next day, felt about 90% back to normal.
57 2021-03-23 numbness Face became numb, had mild hives, continue itchiness for 2 days
57 2021-03-23 seizure 0900 PT arrived on site, expressed that she had a recent mild reaction to PEG during a recent colono... Read more
0900 PT arrived on site, expressed that she had a recent mild reaction to PEG during a recent colonoscopy. States that she broke out with hives on her face and arms. PT was administered 0.5ml of benedryl prior to administration of vaccination and had her wait 10 min for medicine to take effect. 0913 PT was administered 0.3ml of Pfizer COVID vaccine. 0922 PT's started to show signs of distress with heavy breathing. Upon first contact with PT she was speaking with labored breathing. 0924 PT started to seize. Dr. attempted to communicate with PT and reclined her car seat gain better access. Additional information for Item 18: 0925 EMS was called 0925 Epi Pen was administered (successfully) PT started to communicated again but started to feel light headed and nauseous and was returned to a sitting position. RN had taken over and was assisting with PT care. 0938 EMS arrived on scene 1005 EMS cleared scene and transported Pt. to ER.
57 2021-03-23 unresponsive to stimuli Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension... Read more
Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe
57 2021-03-24 weakness 5 minutes after receiving first dose of vaccine, patient was sitting in observation area and began t... Read more
5 minutes after receiving first dose of vaccine, patient was sitting in observation area and began to complain of dizziness, weakness, fatigue and nausea. Patient had rapid breathing and stated she was scared. EMS staff addressed patient and began to assess her when she vomited and had a brief syncopal episode. She was taken to a private area and was monitored. All vital signs repeated, EKG done, Patient was given IV fluids and antiemetic, and the transferred to ED. Patient was alert and oriented with vital normal vital signs upon transfer.
57 2021-03-24 bell's palsy, numbness I had had a severe reaction to the flu shot I received on 9/28/21...developed Bell's Palsy. The sym... Read more
I had had a severe reaction to the flu shot I received on 9/28/21...developed Bell's Palsy. The symptoms lasted a few weeks. Most of the symptoms resolved, but I still have areas of weird sensations that has not gone away. For the immediate treatment, I was given a prescription for steroids and was told I shouldn't have any additional problems for future vaccinations. I was scared to get the COVID vaccine thinking I could have another severe reaction, but I was assured it should not happen again. I had the COVID vaccine on 3/10/21. Yesterday, 3/24/21, exactly 2 weeks to the day, I'm feeling like the Bell's Palsy symptoms are returning. I have had a large fever blister on my mouth and one side of my face is feeling somewhat numb.
57 2021-03-24 tingling Tingling in head on left side, tiredness and some nausea
57 2021-03-24 tingling Tingling down left arm, hand, into right arm, & hand, down both legs And rapid heartbeat. Occurred w... Read more
Tingling down left arm, hand, into right arm, & hand, down both legs And rapid heartbeat. Occurred within 5 mins of getting vaccine, lasted A couple minutes. Should I not get the 2nd vaccine?
57 2021-03-24 tenderness Swelling of the lymph node under my right arm, which is the arm I received the shot. Significant sw... Read more
Swelling of the lymph node under my right arm, which is the arm I received the shot. Significant swelling and tenderness. No other symptoms.
57 2021-03-25 breast pain Extreme breast pain, both right and left for six days. Swollen lymph glands in both arm pits.
57 2021-03-25 feeling cold Severe Head ache Body aches Temp spike Chilling Lump under arm
57 2021-03-25 muscle spasms, hot flush Racing Heart beat, Hot Flash no fever, muscle aches and cramps, feeling unwell
57 2021-03-25 pain in extremity Bilateral cervical adenopathy: swollen lymph nodes in neck, armpits and groin. Significant, obvious,... Read more
Bilateral cervical adenopathy: swollen lymph nodes in neck, armpits and groin. Significant, obvious, very painful swelling extending around back of neck and down left arm. No sore throat, fever.
57 2021-03-26 flushing, tremor approx. 3:10 pm lightheaded, dizzy, flushed, sweaty, shaky, nauseous, headache 5/10 after interventi... Read more
approx. 3:10 pm lightheaded, dizzy, flushed, sweaty, shaky, nauseous, headache 5/10 after interventions, feet elevated, ice pack, water, cracker, patient reported improving symptoms at 4;11pm BP 3:20 122/88 HR 87 pulse ox 97 on room air recheck bp 116/74 at 3:45pm HR 82 pulse ox 98 on room air Patient departed vaccine clinic at 3:15pm a friend was called to drive her home. she stood and ambulated with steady gait unassisted patient alert and oriented to name, dob, place, time at all times
57 2021-03-26 pain in extremity day 2 - Left arm sore - like when you get a tetnus day 3 - whole arm and hand sore, some joint pain ... Read more
day 2 - Left arm sore - like when you get a tetnus day 3 - whole arm and hand sore, some joint pain and fatigue - very tired end of day 3 - Lymph nodes swollen - under left arm 4th day lymph nodes swollen in neck and under arm - left side took Tylenol 2 x a day starting day 2 by 7th day, was no Tylenol needed, lymph nodes gradually went down.
57 2021-03-26 pain in extremity 4pm, 1 hour after shot, throad swelling, stuffy headache, heart bm 99 to 87 to 96, started itching o... Read more
4pm, 1 hour after shot, throad swelling, stuffy headache, heart bm 99 to 87 to 96, started itching on left arm near wrist, arm where shit was. etc., For next 3 hours. Took antihistamine chlortrimitron 2, mucinex 1, drank water. 6pm, hbm 87, 78, felt like palpations, throat more swollen. Kept clearing throat to keep open. 9pm, bm 82, 78, 93, throat not worse, drank water. With heart rate so high, I didn't take epipen. 9:10pm went to bed 12am woke up throwing up intensely. Took prescription promethazine let dissolve in mouth, went to bed. 9am woke up with little nausea, light headache, swollen raw throat. 4:30pm, 25+ hours after shot, throat still really swollen, arm sore, tired.
57 2021-03-26 tingling, numbness I have degenerative back disease and my doctor had given me a prednisone dose pack for me to have on... Read more
I have degenerative back disease and my doctor had given me a prednisone dose pack for me to have on hand if the pain got out of hand. When I started having numbness on the right side of my head (especially my eye lid, upper teeth on the right side, right cheek, ear and behind the ear), I first just used prednisone cream, and found it to help, but not fully. After reading that others had bells palsy after having the shot, and my symptoms seemed similar to bells palsy, I looked up the treatment for bells palsy to be prednisone dose pack. Since I had one on hand, and online stated it would be best to start immediately to avoid any long term effects, I took the first dose on Friday, March 26th. Within 20 minutes my tingling started to subside. I still am experiencing numbness on the right side of my face, but it is significantly reduced, I would say approximately 90% better.
57 2021-03-27 feeling hot, hot flush fuzzy; confused; got really hot; dizzy; flash of heat; This is a spontaneous report from a contactab... Read more
fuzzy; confused; got really hot; dizzy; flash of heat; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207) intramuscular in the right arm on 10Mar2021 (time the vaccination was given: 08:45-09:00) at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had no family medical history. There were no additional vaccines administered on same date of the Pfizer suspect. No previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations within 4 weeks. Adverse event (AE) following prior vaccinations were noted as none (never had a reaction to a vaccine before). It was reported that the patient would like to know if she should receive her second dose of the Pfizer BioNTech COVID-19 vaccine based on the side effects she experienced after receiving her first dose yesterday. She already has an appointment scheduled for second dose. She waited in store 10 minutes after receiving it and felt fine. On the drive home, she felt a little fuzzy or confused and then got really hot and felt a little dizzy, but that went away within 15 minutes. It was further stated that within 15 minutes of getting the vaccine on 10Mar2021, she "got kind of fuzzy" (felt fuzzy) and first confused 09:10, then felt hot and then dizzy 09:15; these events were assessed as serious medically significant. Additionally, she experienced a "flash of heat that went through her body" on 10Mar2021 which went away within 10 minutes. No ER or physician's office required. She felt like if she just got some water, she would be fine. No test was done. The feeling of confusion was what lasted the most and the dizziness did not last very long. The outcome of the events was recovered on 10Mar2021. The events felt fuzzy, confused, hot and dizzy was related to BNT162B2 per reporter.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events fuzzy, confused, feeling hot and dizzy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-03-27 pain in extremity, nerve pain left scars to her left breast still, that look like white crust on them/scars on her left breast; le... Read more
left scars to her left breast still, that look like white crust on them/scars on her left breast; left scars to her left breast still, that look like white crust on them; bumps on her chest that won't heal up; skin blistered up like shingles centered to her left breast in the middle; spots were white and puffy, and some left a bump around; pain in her left chest still from the middle to her arm down to her elbow; pain goes from her front to the back of her shoulder blade and around; nerve pain; every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping; bumps on the left side of the chest/still has lumps, some were white and some have busted open; broke out with what thought as a nurse was shingles; arm swelling after the injection; pain/stabbing pain/nagging pain; pain in her arm that went to her chest area/Under her arm and going down she feels a pinching sensation; Her left arm was swollen at the injection site; This is a spontaneous report from a contactable nurse (patient) from the medical information team. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 22Jan2021 at a single dose (at the age of 57-years-old) for COVID-19 immunisation. The patient was given the vaccine in a pharmacy/drug store. Medical history included diabetes and hypertension. There were no concomitant medications. The patient experienced arm swelling after the injection, then a little later on in the day experienced pain. The next day or so, she got bumps on the left side of the chest. Thought it was shingles and was given medicine for shingles but ended up not being shingles. She still has lumps, some were white and some have busted open, approximately 4. She still had arm pain and back. Arm was still swollen. Went back to doctor on 10Mar2021 and gave another round of antibiotics. Still has a stabbing pain from the from to the back. "1 cm to 1.5 cm." She had scheduled for a breast screening done. She was still having pain almost 2 months later. The patient provided further information: the patient only got her first dose of the vaccine. Her side effects began that day then gradually got worse. Her left arm was swollen at the injection site since 22Jan2021 and was still swollen at the time of the report. A couple of hours afterwards as the day went on, she had pain in her arm that went to her chest area. The next day (23Jan2021), she broke out with what thought as a nurse was shingles, but was just in one little spot, so she went to the doctor and gave her medicine, antibiotics, and then she took those for 7 days three times a day. The first antibiotic she was on when they thought it was shingles was azithromycin (ZITHROMAX). After then, the pain would not go away and has left scars to her left breast still, that look like white crust on them. She has pain in her left chest still from the middle to her arm down to her elbow. She has two different types of pain, and when she went back to the doctor a day before (10Mar2021), she was given more antibiotics. The pain goes from her front to the back of her shoulder blade and around and was a stabbing pain. Under her arm and going down she feels a pinching sensation that won't go away, and was all the time. They wouldn't give her the second vaccine dose while she was on antibiotics that appointment reached its due. The pharmacist came on 05Mar2021 which would be her third appointment to get the vaccine and told the pharmacist her reaction to the COVID shot. The pharmacist asked to look at her injury and then wouldn't give the vaccine to her. Her doctor gave her some pain medication that would be good for nerves. She can't take gabapentin and doesn't like to take pain pills for the nerve pain, so she does paracetamol (TYLENOL) and ibuprofen every other time to relieve the pain. She says she has been taking paracetamol 500mg extra strength twice a day by mouth, and ibuprofen 400mg twice a day by mouth. She was wondering if there was any information on if her pain would get better since she doesn't want to stay the same or for it to get worse that what it is. It was a nagging pain that she can't seem to get rid of and every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping. The gabapentin for her nerve pain gave her side effects, she was taking 300 mg one pill four times a day. She took about three days worth and starting in Feb2021 she thought. The new antibiotic given on 10Mar2021 that she takes for the bumps on her chest that won't heal up was cefdinir 300 mg. She says after her vaccine her skin blistered up like shingles centered to her left breast in the middle, which she thought originally would spread all around but it didn't, it stopped right there. She says that the spots were white and puffy, and some left a bump around in them where they healed up. She says her doctor wanted her to get a mammogram done, which is scheduled for the first Monday in Apr2021. No labs were done, "they just looked at them". The patient felt bumps on the left side of the chest was medically significant because the scars and bumps have been there a while and several were not healing well. The patient has not recovered from the events. Information on the lot/batch number has been requested.
57 2021-03-27 pain in extremity Within 4 hours arm got very sore then started with fever from 101 -103, chills , body aches. Still t... Read more
Within 4 hours arm got very sore then started with fever from 101 -103, chills , body aches. Still today 3 days later arm is sore low grade fever on and off plus severe headache and fatigue
57 2021-03-27 tenderness Stiff neck muscles, especially at base of skull accompanied by pain at the base of skull traveling u... Read more
Stiff neck muscles, especially at base of skull accompanied by pain at the base of skull traveling up both sides of head into temples. Painful temples when touched. Headache was constant throughout the day (1-2) and would flare up 3-4 times a day (6-7). Sometimes relived by Tylenol. Often caused eye pain when severe.
57 2021-03-27 tremor, tingling At 1206 called RN over since pt was shaking and sweaty. @1207 shaking but talking. EMS arrive. @12... Read more
At 1206 called RN over since pt was shaking and sweaty. @1207 shaking but talking. EMS arrive. @1208 lower to the ground, feet elevated. @1209 114/72, OSat 99%, HR 68. @1211 c/o tingly hands. @1212 BP 142/86, OSat 100% HT 72. @1214 131/84, OSat 100%, HR 69%. 1221 c/o headache, sitting up, drinking water. @1225 Pt is sitting up and eating a snack. @1240 Pt is standing and states she is feeling much better and ready to go. @1244 Pt escorted to the door and advised to sit and call for help if necessary.
57 2021-03-28 bell's palsy Bell's Palsy; Sharp headaches; cold; This is a spontaneous report from a non-contactable consumer. A... Read more
Bell's Palsy; Sharp headaches; cold; This is a spontaneous report from a non-contactable consumer. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, on an unspecified date at 57 years old (Batch/Lot Number: EL9264) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced sharp headaches and cold then she went to ER, diagnosed with Bell's Palsy on an unspecified date. The events resulted in a Doctor or healthcare professional office/clinic visit and/or Emergency room/department or urgent care. Treatment was received for the events. The outcome of the events was unknown.
57 2021-03-28 facial paralysis, numbness Patient started experiencing numbness and droopiness from her right cheek upwards towards her eye. N... Read more
Patient started experiencing numbness and droopiness from her right cheek upwards towards her eye. No other symptoms or alteration of her vision. Patient was checked for signs of a stroke to which there were none.
57 2021-03-28 hypersensitivity of all senses Temp 102 on Saturday, reduced with ice packs and 650mg tab Tylenol to 101.3 on Sunday. Fever broke t... Read more
Temp 102 on Saturday, reduced with ice packs and 650mg tab Tylenol to 101.3 on Sunday. Fever broke through night Sunday using ice packs w slight 99 on Monday. Severe headache and joint pain Saturday morning- took 600 mg advil no affect, took 400mg advil Saturday afternoon, 2 rounds of 400mg advil Sunday. By late afternoon Sunday joint pain subsided. Monday feel sore and very stiff with mild headache. Also experienced skin sensitivity Saturday morning. Hurt to touch my skin. Had difficulty with moving clothes across my legs. Monday general fatigue. Throughout weekend took in water and B complex drink supplement to maintain hydration. Staggered advil and tylenol by 4 hours.
57 2021-03-28 numbness About an hour after the shot the front of my face felt numb. It lasted about 20 minutes. Very disc... Read more
About an hour after the shot the front of my face felt numb. It lasted about 20 minutes. Very disconcerting. Tomorrow is my second shot and I?m scared.
57 2021-03-28 tingling, cold extremities Patient with onset of facial tingling and sensation of facial swelling and tongue swelling approxima... Read more
Patient with onset of facial tingling and sensation of facial swelling and tongue swelling approximately 10 min after receiving the second dose of her COVID-19 vaccine. This persisted throughout evaluation. She received the first dose of her COVID-19 vaccine 3 weeks prior, without adverse effects. She had progression of symptoms during her evaluation, with some chest pressure, described as a sensation of a brick sitting on her chest, duration approximately 10 min at the time of evaluation, continual, approximately 3/10 on pain scale, persisting chest pressure worse with deep breathing. Oxygen saturations were stable at 95%, anterior breath sounds clear with good air exchange, distant heart sounds. Good peripheral pulses, perfusion difficult to assess since fingertips were cold due to cold external air temperatures. She was transferred from private vehicle to ambulance and oxygen was placed and EKG obtained as below. She was then transferred to hospital for further evaluation. Of note, the patient reported that during the day prior to receiving the second dose of her vaccine, she had worsening shortness of breath with need for supplemental oxygen, 2L by nasal cannula, with activity and at rest. Onset prior to her evaluation after her vaccination. This is above her baseline of nocturnal oxygen use. She was feeling poorly prior to presenting for the vaccine. She had been hospitalized with intubation for CHF exacerbation in the week prior to 2nd dose COVID-19 vaccine administration.
57 2021-03-28 tingling I felt a little strange during the waiting period, but could not define anything specific. I waited ... Read more
I felt a little strange during the waiting period, but could not define anything specific. I waited 20 minutes to be safe and put it down to a possible anxious feeling, although I was not anxious before I arrived. I felt fine after arriving home. At midnight when I went to bed I noticed a tingling feeling in my arms , hand and , legs and a slight bit across my chest. It was obvious enough that it prevented me from sleeping well. This morning I still feel the tingling but notice that it is most obvious if I am sitting still vs up moving around.
57 2021-03-28 tremor, numbness Felt shaky after about 5 minutes , not right pain travel from shoulder up back of neck facial numbne... Read more
Felt shaky after about 5 minutes , not right pain travel from shoulder up back of neck facial numbness almost half way across mouth up to eye area on same side as injection
57 2021-03-29 weakness I was tired and lethargic feeling Friday evening then Saturday was basically the same Sunday was the... Read more
I was tired and lethargic feeling Friday evening then Saturday was basically the same Sunday was the worst I felt like I was going to throw up I had pain in my lower right side of my back also pain in my neck lymph node areas also pain in my knees it seems like it targets previous injuries also I had a low-grade fever nauseousness chills couldn't sleep fatigued just terrible feeling this morning is Tuesday March 30th I'm starting to feel better but I still really weak just really weak and my throat has been sore since like Saturday.
57 2021-03-29 feeling cold fever, chills, severe headache, achey bones, freezing, foggy brain, nausea almost 12 hours after sh... Read more
fever, chills, severe headache, achey bones, freezing, foggy brain, nausea almost 12 hours after shot, last symptom left 4 days after administration
57 2021-03-29 numbness About 20 minutes after receiving the vaccination, my left side became numb, especially my face and h... Read more
About 20 minutes after receiving the vaccination, my left side became numb, especially my face and head. And my left eye was watering.
57 2021-03-29 pain in extremity Headache, pain in arm where vaccine administered, body aches, fever
57 2021-03-29 tingling, flushing PATIENT REPORTED FEELING TINGLY AND "FUNNY". PATIENT WAS FLUSHED ON HER FACE AS WELL AT THE END OF ... Read more
PATIENT REPORTED FEELING TINGLY AND "FUNNY". PATIENT WAS FLUSHED ON HER FACE AS WELL AT THE END OF THE 15 MINUTE OBSERVATION TIME. ADVISED PATIENT TO CONTINUE TO WAIT. PATIENT CONTINUED TO FEEL "STRANGE" AND PHARMACY STAFF PROVIDED HER WITH SOME COLD WATER. PHARMACIST ASKED IF SHE WAS HAVING ANY TROUBLE BREATHING AND PATIENT RESPONDED NEGATIVE. PHARMACY STAFF ALSO CHECKED HER BP AND IT WAS AT 166/88. EMSA WAS NOTIFIED WHEN PATIENT'S SYMPTOMS HAD NOT CHANGED AND ARRIVED AT 10:50. PATIENT WAS TAKEN BY EMSA TO ED.
57 2021-03-30 weakness, seizure nauseous and vomited; nauseous and vomited; feeling weak; short of breath; I began seizing at the sc... Read more
nauseous and vomited; nauseous and vomited; feeling weak; short of breath; I began seizing at the scene; tired; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiration date: unknown), via an unspecified route of administration administered in left arm on 05Mar2021 at 00:30 as single dose for COVID-19 immunization. Medical history included hypertension (HTN), and known allergies to erythromycin. Concomitant medication included atenolol and furosemide, both for unspecified indication. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 12Feb2021 at 15:00 in left arm for COVID-19 immunization. Within a few hours after administration of the second vaccine on 05Mar2021, the patient became tired so went to bed early. Upon awakening the following morning (06Mar2021), the patient was nauseous and vomited. She got herself ready for work but noticed she was feeling weak, tired and had short of breath resulting in worsening of symptom. The patient then got in her car hoping to feel better with fresh air. However, her condition significantly worsened resulting in me calling number due to fear that she may expire. Upon arrival of emergency services, her condition significantly worsened, the patient was weak and unable to open car door. She was informed by medical personnel that she began seizing at the scene, in the ambulance and in the ED. Once she was stabilized in the ED, she was admitted for 3 days to continue tests and evaluations. The outcome of the events was recovering. The patient had no COVID-19 prior to vaccination. The patient was tested post vaccination via nasal swab on 06Mar2021 and was negative. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage.; Sender's Comments: Considering the plausible temporal association and lacking any reported alternative explanation, a causative role of BNT162B2 vaccine for all reported SAEs cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-03-30 weakness Severe Body aches headache severe weakness sleeping constantly diarrhea abdominal pains dizziness na... Read more
Severe Body aches headache severe weakness sleeping constantly diarrhea abdominal pains dizziness nauseous
57 2021-03-30 pain in extremity After I got the first dose, I experienced fever, headaches, sore arm; After I got the first dose, I ... Read more
After I got the first dose, I experienced fever, headaches, sore arm; After I got the first dose, I experienced fever, headaches, sore arm; After I got the first dose, I experienced fever, headaches, sore arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264), via an unspecified route of administration, administered in left arm on 06Feb2021 at 16:30 (at age of 57 years old, no pregnant at vaccination) at a single dose, for COVID-19 immunization. Medical history included Known allergies: food reactions to shrimps, crabs, lobsters- and occasionally to pineapples, avocado and eggs; also had reactions to penicillin, sulfa- type medications. Other medical history: none. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. After the patient got the first dose, she experienced fever, headaches, sore arm-however they went away in a couple of days. The outcome of the events was recovered.
57 2021-03-30 pain in extremity Sore arm extending up to neck; Sore arm extending up to neck; fatigue; This is a spontaneous report ... Read more
Sore arm extending up to neck; Sore arm extending up to neck; fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 25Feb2021 at 12:30 (at the age of 57 years old) (Batch/Lot Number: EL3247) as a single dose for COVID-19 immunisation. Medical history included sjogren's syndrome from an unknown date, breast cancer female with radiation from an unknown date, cholecystectomy from an unknown date, right knee arthroscopic surgery for chondromalacia from an unknown date, bilaterial fusion L4/L5 from an unknown date, vertigo from an unknown date, and allergy to bee sting from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; berberis vulgaris root, camellia sinensis leaf extract, coptis chinensis root, curcuma longa rhizome, fallopia japonica root with rhizome, origanum vulgare leaf, rosmarinus officinalis leaf, scutellaria baicalensis root, zingiber officinale rhizome (ZYFLAMEND) taken for an unspecified indication, start and stop date were not reported; glucosamine (GLUCOSAMINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore arm extending up to neck on 25Feb2021 at 17:00 with outcome of recovering, and fatigue on 25Feb2021 at 17:00 with outcome of recovering. Treatment was not received for the events. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
57 2021-03-30 tingling Constant face itching and tingling. I noticed it a day after the shot. It has been getting worse a... Read more
Constant face itching and tingling. I noticed it a day after the shot. It has been getting worse as the days progress. At first I thought it was my face cream, however I have washed it off and the itching has not gone away since receiving the shot.
57 2021-03-30 tingling reported left arm "tingling" on exit of a parking lot after having waited 30 mins (observation lot)-... Read more
reported left arm "tingling" on exit of a parking lot after having waited 30 mins (observation lot)- asked to be seen by medical. "nervous" anxious" " involved in 911 and anthrax- had to take meds and this brought me back" Given emotional support. mask removed - fresh air. additional wait time - 25 mins. monitoring. Drove off lot when calm & felt able.
57 2021-03-30 tremor, pain in extremity Approximately 18 hours after shot, woke up with extreme chills; body shaking head to toe; fever of 1... Read more
Approximately 18 hours after shot, woke up with extreme chills; body shaking head to toe; fever of 100.5; Left arm very sore; it was swollen and very red; it was swollen and very red; it feels itchy; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer(patient) reported that:A 57-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247)dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 07:45 asfor covid-19 immunisation .The patient medical history was not reported. The patient experienced approximately 18 hours after shot, woke up with extreme chills on 12Feb2021 01:00, body shaking head to toe on 12Feb2021 01:00 and, fever of 100.5 on 12Feb2021 01:00 and, left arm very sore and on 12Feb2021 01:00 and it was swollen and very red on 12Feb2021 01:00 and , it was swollen and very red on 12Feb2021 01:00 and, it feels itchy on 12Feb2021 01:00 and.The patient underwent lab tests and procedures which included body temperature: 100.5 on , body temperature: 101.9 and Approximately 18 hours after shot, woke up with extreme chills, body shaking head to toe and fever of 100.5 Took 600mg Ibuprofen, an hour later fever was 101.9, took 400mg Ibuprofen. Left arm very sore noticed that it was swollen and very red on Saturday. Swelling continued to get worse & redder & is still present today (Monday) & it feels itchy. Fever finally stopped Sunday evening. Every time the fever returned it took 1000 mg Ibuprofen and about 2 - 2-1/2 hours to go down and outcome of the events was not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.
57 2021-03-31 migraine right after the injection, I felt a stiffening sensation in my jaw on the right side, about 1 hour l... Read more
right after the injection, I felt a stiffening sensation in my jaw on the right side, about 1 hour later I started to feel a pressure on both of my temples and developed a migraine headache over night, the migraine intensified the following day, I felt nausea and vomitted for couple of hours during the evening on the second day following the vaccination. I have also felt pain in the site of the vaccination and the area was warm. The headache lasted for 5 days and I felt fatigued for 10 days following the vaccination.
57 2021-03-31 pain in extremity 1ST VACCINE- 1/11/2021 VERY SORE ARM, SAME DAY AS VACCINE . 1ST VACCINE. SECOND VACCINE WAS GIVEN O... Read more
1ST VACCINE- 1/11/2021 VERY SORE ARM, SAME DAY AS VACCINE . 1ST VACCINE. SECOND VACCINE WAS GIVEN ON 2/01/2021 AND ARM WAS ALSO SORE SAME DAY, DAY TWO, HORRIBLE HEADACHE BEHIND MY RIGHT EYE, NAUSEA, WEAKNESS IN LIMBS. ON 2/25/2021 HAD HORRIBLE STOMACH PAINS, THE NEXT MORING WENT TO ER. HAD ACCUTE APPENDICITIS. HAD APPENDIX REMOVED THE EVENING OF 2/26/2021. I NOW HAVE SOMETHING WRONG WITH MY LUNGS OR HEART. I AM CURRENTLY SEEKING TREATMENT AT CARDIOLOGY.
57 2021-03-31 tremor Transient High Blood Pressure and Tremulousness requiring emergency room visit
57 2021-03-31 tremor Pain at injection site, fatigue, shaking chills
57 2021-04-01 cold sweat I got nauseas and clammy. Then started getting dizzy. Next morning the 1st, I had vertigo very bad... Read more
I got nauseas and clammy. Then started getting dizzy. Next morning the 1st, I had vertigo very bad. Still have it today the 2nd. But tiny but better. Been online, several people have it after vaccine. I'm scared to take 2nd shot?
57 2021-04-01 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
57 2021-04-01 muscle spasms I'm 10 years post menopause. Vaginal bleeding began the day after injection with severe cramping. Bl... Read more
I'm 10 years post menopause. Vaginal bleeding began the day after injection with severe cramping. Bleeding continues as of this writing. Went to primary care doctor. She said this is the second person in their office who have had similar reaction. Doctor ordered pelvic ultrasound and advised me to see my GYN next week.
57 2021-04-01 pain in extremity Slight soreness in arm. 4:00AM next day when i awoke, i had an upset stomach, slight chills, faint f... Read more
Slight soreness in arm. 4:00AM next day when i awoke, i had an upset stomach, slight chills, faint feeling. Immediately, took 1 Aleve, and by 5:30, i was already feeling better. All symptoms went away, INCLUDING the soreness in my arm. I really didn't feel good at all. I never miss work, but i was very close to calling in sick.
57 2021-04-01 pain in extremity ASSESSMENT: 57 y.o. female with PMHx of HTN who presented today to the Vaccine site for her second C... Read more
ASSESSMENT: 57 y.o. female with PMHx of HTN who presented today to the Vaccine site for her second COVID vaccine. She c/o only a sore arm for 1-2 days after her first vaccine but otherwise tolerated it well. NKDA. She states that about 5-10 min after the vaccine she developed rhinorrhea so she went to the bathroom and blew her nose and it improved some but did not resolve. She did not inform us of this until her 15 min timer went off so I completed an evaluation. I am the physician assistant on site at the vaccine clinic who monitors the patients and is there for emergencies. If a patient feels they are having a reaction I complete an exam on the patient. She states the rhinorrhea was still there but was better than it was. Associated with a sensation of "oil in my throat, like eating some butter" but denies throat itching or tightness. Associated with intermittent dry cough and throat clearing. Denies difficulty breathing, wheezing, tongue/lip swelling, mucosal or skin itching, hives, palpitations, lightheadedness, dizziness, SOB, headache, nausea, vomiting, diarrhea, abdominal pain. She has experienced similar rhinorrhea and dry cough in the past with certain medical masks like the one we provided her today. She also experiences this with her seasonal allergies. Her allergies have not been flaring up the last 2 weeks or so but they were before that. She states she has dry mouth and has to drink a lot of water or she will develop a dry cough and throat clearing like she has today. Reports she has never had an allergy to any vaccine or injectable medication in the past. ROS: Constitutional: Negative for chills, fatigue, fever, diaphoresis and weakness. Eyes: Negative for blurred vision, photophobia, vision loss and visual disturbance. E/N/T: Positive for rhinorrhea. Negative for hearing loss, ENT Pain, ear pain, nasal pain, sore throat and hoarseness. Cardiovascular: Negative for chest pain, palpitations, tachycardia, edema, dyspnea on exertion, irregular heartbeat and near-syncope. Respiratory: Positive for cough (dry, intermittent, associated with PND). Negative for shortness of breath, wheezing and sputum production. Gastrointestinal: Negative for abdominal pain, diarrhea, stool changes, nausea and vomiting. Musculoskeletal: Negative for myalgias. Integumentary: Negative for pruritus, rashes, color change and flushing. Neurological: Negative for dizziness, headaches, paresthesias, weakness, difficulty with concentration, disturbances in coordination, focal weakness, light-headedness, loss of balance and vertigo. Allergic/Immunologic: Positive for allergies and environmental allergies. Negative for frequent illnesses, urticaria, hives and persistent infections. Psychiatric/Behavioral: Negative for anxiety and depression. OBJECTIVE: Vitals: 15 min after vaccination B/P: 140/88 Pulse: 70 Temp: 98.2 Resp: 12 SpO2: 99% Vitals: 25 min after vaccination B/P: 148/90 Pulse: 68 Resp: 14 SpO2: 98% Vitals: 40 min after vaccination B/P: 150/92 Pulse: 67 Resp: 12 SpO2: 99% Vitals: 70 min after vaccination B/P: 142/82 Pulse: 70 Resp: 12 SpO2: 99% PHYSICAL EXAM CONSTITUTIONAL Vitals reviewed. GENERAL APPEARANCE: Well-developed. GROOMING: Well groomed. LEVEL OF DISTRESS: The patient is not distressed, nervous/anxious, diaphoretic or tearful. She appears to be well. The patient is not lethargic or toxic. The patient does not appear tired. EYES: LIDS/CONJUCTIVA: Lids and conjunctiva are normal. PUPILS/IRIS: extraocular movement intact. ENT EXTERNAL EARS/NOSE: External ears and nose are normal. SEPTUM/MUCOSA: Negative for sinus tenderness. LIPS/TEETH/GUMS: Normal lips, teeth and gums. No lip edema. OROPHARYNX:Mucosa: Mucosa appears normal. No edema of lips, face, tongue, oropharynx or posterior pharynx NECK: Neck normal. RESPIRATORY EFFORT AND PATTERN: Effort normal. No tachypnea, intercostal retractions, accessory muscle usage, hypopnea and irregular rate. AUSCULTATION: Normal breath sounds with no rales, rhonchi, wheezes or rubs. No coarse breath sounds or decreased breath sounds. CARDIOVASCULAR AUSCULTATION: Rate: Is normal. Rhythm: regular. Heart sounds: S1 is normal. S2 is normal. S3/S4 not present. With no murmurs heard. EDEMA/VARICOSITIES: No edema or varicosities. RADIAL: radial pulses normal bilaterally PEDAL PULSE: Normal bilateral posterior tibal pulses. LYMPHATIC OTHER NODES: No neck adenopathy. MUSCULOSKELETAL STABILITY: Normal stability. INTEGUMENTARY SKIN INSPECTION: Normal. PALPATION: Normal. No diaphoresis, no flushing, no urticaria Injection site is unremarkable, no swelling or erythema NEUROLOGICAL GAIT, COORDINATION, REFLEXES Gait: normal PSYCHIATRIC ORIENTATION: She is alert and oriented to person, place and time. MOOD/AFFECT: Normal mood and affect. INSIGHT/JUDGEMENT: Normal insight/judgement. The patient has good insight with good judgment. ASSESSMENT/PLAN: Rhinorrhea - Airway remained clear, breathing was normal, circulation was good and mentation was good. - She was monitored for 60 min after the rhinorrhea began, vitals remained stable and WNL (despite slightly elevated BP). She drank 1.5 bottles of water which improved her dry cough. She stated she was feeling back to normal before she left the clinic. - Warned her that she likely was having a mild allergic reaction to the vaccine and warned that it is possible for allergic reactions to worsen. Reviewed signs and symptoms of anaphylaxis in detail and gave strict ER warnings if any develop, especially difficulty breathing, throat/facial swelling or any worsening symptoms occur. Warned her while driving to work (15 min drive) she keep an eye on her symptoms and pull over and call 911 if any signs or symptoms of anaphylaxis develop. - Advised she take a non-sedating antihistamine like Claritin on her way to work. I advised she let her colleagues at work now to keep a close eye on her at work. - She expressed understanding and stated she was feeling well and wanted to go to work - All questions were answered. I informed her PCP and sent them my note. I called 4 hours after the vaccine to follow up but had to leave a voicemail,. I spoke with her the following day on 3/31/21 and she stated she felt great besides localized soreness at the injection site. Otherwise she felt well. The rhinorrhea, cough and throat clearing had completely resolved after taking 1 claritin. Denied shortness of breath, difficulty breathing, wheezing, fever, chills, n/v/d, chest pain, hives, itching, palpitations, dizziness, syncope, neear syncope or headache. She did not require any further treatment and did not need to have a visit with her PCP and did not need to go to the ER or hospital.
57 2021-04-01 tingling Patient experienced tingling all over, a dry tongue, and now was experiencing chills. Currently wait... Read more
Patient experienced tingling all over, a dry tongue, and now was experiencing chills. Currently waiting for provider to see her in the ED.
57 2021-04-02 burning sensation I woke up at approx. 2:30 am the next morning with my mouth (tongue and lips), eyes, and inside of ... Read more
I woke up at approx. 2:30 am the next morning with my mouth (tongue and lips), eyes, and inside of nose on fire, as if dipped in hot sauce. Anywhere I touched burned. It felt like it was coming out of my pores, and I jumped into the shower to rinse off, spreading "it" everywhere. The redness and blisters would migrate every hour or so. One minute it was my tongue, then it would show up on my chest. I called the advice nurse who instructed me to take a Benedryl. My tongue and throat were tingling. The Benedryl helped, and I was able to go back to bed but woke up four hours later worse than before. I called again and my PCP was alerted. via email. She prescribed a run of Prednisone and that stopped it, however after the run was over, it started again. A second run of Prednisone was taken. Upon completion, my throat started to tingle again, then stopped. I have pictures of the hives, swelling, and blisters on my tongue, lips, eye, and chest, I cannot take the second dose, per PCP.
57 2021-04-02 burning sensation Immediate pain in left arm upon injection, Burning sensation in ears, face, neck and shoulder within... Read more
Immediate pain in left arm upon injection, Burning sensation in ears, face, neck and shoulder within minutes of injection. Redness and blotchiness apparent on skin. Fever of 100.9 within an hour of injection. Fever continued for two days. general fatigue and muscle and joint soreness. Stayed in bed for two days. Administered Benadryl and Tylenol as needed as suggested by the pharmacist at location
57 2021-04-02 feeling hot Patient presented today for her second COVID-19 vaccination. Before processing her dose, she express... Read more
Patient presented today for her second COVID-19 vaccination. Before processing her dose, she expressed concerns over a reaction she had to her first dose. After her first dose, she had nausea/vomiting and generalized hives and presented to the ER. Her treatment included IV benadryl followed by oral benadryl ATC until her hives subsided. She was hesitant to receive her second dose, but we encouraged her to go ahead and that we were prepared with benadryl if she needed it again and asked that she wait an extended 30 minutes post vaccination. Patient received her vaccine at 3:15pm and sat down. After about 10 minutes she started getting hot and nauseous. She did vomit twice but said she was feeling better than she did after her first dose. However, at 3:30 she started feeling itchy and could feel hives forming. I gave her 25mg of benadryl and we sat her by a fan. at 3:48 she was still feeling a little itchy so I gave her another dose of 25mg of benadryl. At 4:00 she insisted she was "feeling ok and wanted to go home because her daughter was there to pick her up and she was just so embarrassed about her reaction". I allowed her to leave because this was how she presented after her first vaccine and was treated with benadryl. I instructed her to continue taking benadryl 25mg ATC until her hives subside. She expressed understanding and was walked her to the back door where her daughter was waiting for her.
57 2021-04-02 pain in extremity, breast pain Severe HA, muscle pain, fever, chills, nausea, stomach pains, shortness of breath, cough, sore arm ... Read more
Severe HA, muscle pain, fever, chills, nausea, stomach pains, shortness of breath, cough, sore arm and breast
57 2021-04-02 tingling, numbness Increase BP, client verbalized itchy throat, numbiness/tingling to right and left arm.
57 2021-04-03 weakness Became very tired at 7:30 pm - to bed by 9:30. Fell asleep right away. Woke at 1:00 a.m. unable to m... Read more
Became very tired at 7:30 pm - to bed by 9:30. Fell asleep right away. Woke at 1:00 a.m. unable to move. My arms legs and body were too heavy to move. I had to call out to my fiance' to wake him to help me. He had to physically move my body, set me up with pillows. I was not able to swallow so it took a bit to get three ibuprofen down. I could breath ok but incredibly scary to not be able to move or swallow. Still very tired. Fell asleep sitting with head tipped to the side as I was afraid to throw up but couldn't speak to my fiance' to get a bucket. Woke up at 7:00 a.m. able to move all body parts. Throat still swollen but eventually I was able to swallow. Tired throughout the day. Light headed, weak, and dizzy.
57 2021-04-03 feeling hot Both shots, extreme body aches, terrible headache, so cold it felt like ice running through my bones... Read more
Both shots, extreme body aches, terrible headache, so cold it felt like ice running through my bones, then hot. First shot temp got to 101.4 and second shot it got to 102.4 Throwing up and nauseous and dizzy.
57 2021-04-03 muscle spasms I got very dehydrated. I had cramping in both legs and feet. I drank a lot of water before and after... Read more
I got very dehydrated. I had cramping in both legs and feet. I drank a lot of water before and after I received the vaccine. I had to keep waking up to drink more water. After drinking 2 bottles ( 23.7 fl oz each) I was hydrated enough that the cramping stopped. 4/3 and 4/4 I am still feeling a little dehydrated.
57 2021-04-03 nerve injury nerve damage; she didnt sleep; Fatigue; This is a spontaneous report from a contactable consumer (pa... Read more
nerve damage; she didnt sleep; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux which was under control. She has been good for last 2 months. Two years ago (2019), she did have her polyps removed from uterine wall, it was done as outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She has had no positive antibody or COVID test prior to the vaccine. Concomitant medication included famotidine (PEPCID) for acid reflux. The patient previously took flu vaccine. She was getting flu shot every year with no issue. She had a previous reaction to anesthesia (unspecified) which include feeling tired ang groggy. The patient had a weird, not the usual reactions, like she had read about. On 20Jan2021, she experienced fatigue, achy pain, and shoulder and joint pain. She even went to the doctor yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which was a good thing, but her question was if she should take the second shot. The nerve damage started on 20Jan2021 at 10:00 that night causing shoulder pain, back pain, and lower back pain; because of it, she was not able to sleep. She only slept for 3 hours on Thursday night. She is a teacher and even had to miss school on Friday. It was just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in her shoulder went to the arms, back across to the front of the chest, she could follow it with her hand, it was achy all on the left side. She went to the doctor and said it was nerve damage. When she got the actual shot, she felt nothing, she couldn't even feel it from nurse, it did not hurt. It was not going away. The patient spoke with her friend, and her friend told her that it sounds like what she was experiencing or how she was responding was as if she has the COVID virus. Then, she was diagnosed with nerve damage by a healthcare professional. Her first dose was on 20Jan2021, the nerve damage symptoms began that same night. She was schedule for the second dose on 10Feb2021. She further reported that the symptoms were ongoing, but it was better. Her lower back pain was gone. Now, it was just localized to her shoulder, upper back, and across the chest. The patient was not taking any new medicine. She actually read to not even take TYLENOL OR ADVIL 2 days prior as it can lessen the effectiveness of the vaccine. That was why she didn't take TYLENOL until Friday afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she could take ADVIL right now. The healthcare professional did not do any test, she really just left the office hoping that it would resolve on its own. The outcome of the event nerve damage was recovering and unknown for all other events. Follow-up attempts are completed. No further information is expected.
57 2021-04-03 pain in extremity Can't stop shivering with chills even in hot tub with heater on in room, headache, sore arm, metalli... Read more
Can't stop shivering with chills even in hot tub with heater on in room, headache, sore arm, metallic nasty taste mouth, cough, fatigue
57 2021-04-03 pain in extremity My arm was sore for a day or so after the second shot. Then it felt fine. On day seven I woke up to ... Read more
My arm was sore for a day or so after the second shot. Then it felt fine. On day seven I woke up to a very sore arm again. As bad or worse than the initial soreness
57 2021-04-03 pain in extremity Sore arm/Soreness; This is a spontaneous report from a contactable consumer. A 57-year-old (non-preg... Read more
Sore arm/Soreness; This is a spontaneous report from a contactable consumer. A 57-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262) via an unspecified route of administration at left arm on 01Feb2021 at single dose for COVID-19 immunisation. Patient's medical history included headache. The patient's concomitant medications were not reported. It was unknown that patient took any other vaccine in four weeks. On 01Feb2021, the patient experienced sore arm/soreness. Soreness started about 4-5 hours after dose was administered and lasted approximately 14 hours. Treatment was not received for adverse event. There was no COVID prior vaccination and also no COVID tested post vaccination. The outcome of event was recovered.
57 2021-04-03 tingling, numbness Injection painless. Within 30 seconds tingling in left arm. Within an hour confusion/brain fog, ting... Read more
Injection painless. Within 30 seconds tingling in left arm. Within an hour confusion/brain fog, tingling and swelling in arm and at injection site, body aches, fever, chills, feeling unwell, racing heartbeat, feeling panicky, felt unwell in my brain for a period of two weeks. After day 12 still having side effects, numbness, tingling in my arm shoulder and across my back. I have canceled my second vaccine and do not intend I?m getting another until I get a call from you. I would like to speak with someone about the symptoms and why they occurred.
57 2021-04-03 tingling, pain in extremity, numbness, cold sweat Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. F... Read more
Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. Felt terrible and went to be early. Did not sleep well. Woke up Wed 3/31 feeling better but lightheaded/dizzy; dull headache; arm swollen /sore. Thursday 4/1 still lightheaded and more dizzy when I bent down or turned suddenly; arm still sore. Friday 4/2 morning left side of face started to feel numb/tingling , then left fingers/hand, then left toes/foot, then left calf. Checked possible stroke symptoms and no other symptoms so called Dr. NP said to go to ER since it was unilateral numbness/tingling. Admitted to ER about 11:15am and did stroke protocol to rule out stroke...got CT scan, EEG, and MRI with & without dye. All normal. Discharged about 5:45pm. Very lethargic. Sat 4/3 still lightheaded/dizzy and lethargic. Woke up about 3am early Sun (Easter 4/4) in cold sweat and nauseous; vomited; hardly slept. Feel very lethargic today and still lightheaded/dizzy.
57 2021-04-03 tenderness tenderness; felt very fatigued; This is a spontaneous report from a contactable healthcare professio... Read more
tenderness; felt very fatigued; This is a spontaneous report from a contactable healthcare professional (patient). This 57-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL1284) intramuscularly on 03Feb2021 (at the age of 57-years-old) as a single dose in the right deltoid for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously received dose 1 of BNT162B2 (lot number EK4176) on 09Jan2021 as a single dose in the left arm for COVID-19 immunization. On an unspecified date after dose 2 of BNT162B2 the patient experienced tenderness and felt very fatigued for about 24 hours. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of tenderness and very fatigued were unknown. No follow-up attempts are needed. No further information is expected.
57 2021-04-04 feeling cold Severe chills, pain in skull/cranium, lower back ache, dry heaves, loss of appetite, very tired.
57 2021-04-04 numbness, tingling patient reports numbness in 3 of her fingers and tingeling
57 2021-04-04 migraine Every gland swelled up in my body! All my joints inflamed! Had viral migraines so bad put cold pack ... Read more
Every gland swelled up in my body! All my joints inflamed! Had viral migraines so bad put cold pack on my arm,back of head and neck! Had a cold pack on my forehead! Took doses of Benadryl and tylenol! Feel like I got ran over and poisoned! Next day cold chills! Sores in my mouth throat red! Eyes glassy! Upset stomach inflamed anus! Fatigued legs are weak dizzy!
57 2021-04-04 pain in extremity, tingling This was my 2nd shot. On the first shot my arm was ?tingly? like pins and needles and my elbow hur... Read more
This was my 2nd shot. On the first shot my arm was ?tingly? like pins and needles and my elbow hurt . 2nd shot was Tuesday at 11 am. I felt fine until about 9 pm and then my arm started hurting couldn?t lift it over chest level. It hurt from shoulder to elbow. Didn?t sleep well at all kept waking up. Day after shot was Wednesday and I had a slight headache and arm still hurt a little. Very tired but I hadn?t slept well. Worked all day. Thursday I worked all day, arm no longer hurt but elbow still feels weird. Friday, 3 days after the shot, I felt fine until after lunch. I got a headache that wouldn?t go away. Started feeling nauseous about 5 PM. Went home and had chills and shivering. Temp went up to 100. Massive headache and horrible nausea. Extremely fatigued. Fell asleep about 7 PM and woke up at 9 PM. Back to sleep by 9:30 PM and slept till 1 am. Back to sleep at 2 am and slept till 8 am so about 12 hours of sleep which o rarely sleep more than 7. This was 3 days after the shot. Woke up Saturday and felt ok as I have since then. My elbow still hurts and there may be a small lump under my skin at the elbow...or some swelling. Had very strange vivid dreams on Friday night as well.
57 2021-04-04 pain in extremity It was suggested by a nurse to report this. I had vague achy feeling from the waste down the lasted ... Read more
It was suggested by a nurse to report this. I had vague achy feeling from the waste down the lasted a few hours on the same day 1st vaccine was received. Vague aches and pains where mostly in legs. Very slight. Lasted a few hours
57 2021-04-04 pain in extremity Soreness in arm for 3 days. Sore legs while walking 6-7 hours post injection.
57 2021-04-04 pain in extremity 1) Sore arm that went up into my shoulder blade 2) Chills 3) Fever 4) Headache 5) Pain in joints &... Read more
1) Sore arm that went up into my shoulder blade 2) Chills 3) Fever 4) Headache 5) Pain in joints & jaw 6) Exhaustion 7) Red face 8) Simply don?t feel good at all This this Monday 4/5/21... the symptoms lasted all weekend. This morning the pain in arm and joints has gone down but is still there; this is the first morning I woke without a fever but low grade fever returned this afternoon as did the redness in my face & headaches.
57 2021-04-05 difficulty speaking Patient received her first Pfizer COVID-19 vaccine. Approximately 25 minutes later she developed a ... Read more
Patient received her first Pfizer COVID-19 vaccine. Approximately 25 minutes later she developed a feeling of throat swelling, hoarse voice and difficulty swallowing. She was unable to swallow water. She was treated in the ED with EpiPen, Solumedrol and Benadryl. Patient was admitted to ICU for airway monitoring.
57 2021-04-05 flushing Flushing/sweating. Vitals wnl/stable, given water and orange juice.
57 2021-04-05 muscle spasms Day # 2: pain at injection site 2-21: itchy throat with cough (mostly dry with lite phlegm) hacking ... Read more
Day # 2: pain at injection site 2-21: itchy throat with cough (mostly dry with lite phlegm) hacking and severe choking at times 2-21: shortness of breath, at times complete loss when coughing/choking 3-7: malaise, sleepy 3-7: muscle aches, especially legs with calve spasms 7-21: sinusitis 7-21: upset stomach, gassy, gurgling, loose stools, heartburn 8-12: losing sense of taste 12-16: complete loss of taste 16-21: taste returning, but still "off"
57 2021-04-05 tingling, weakness, tremor pre vaccination symptoms of a patient : panic ; sweating; headache; tingling her hand and leg; very... Read more
pre vaccination symptoms of a patient : panic ; sweating; headache; tingling her hand and leg; very week; shaking and chils. Symptoms was resolved and patient went home after she took her vaccine.
57 2021-04-06 cold sweat on day 2 extreme tiredness and joint pains, Day 3 and 4 added by dry heaving. stomach ache, diarreah... Read more
on day 2 extreme tiredness and joint pains, Day 3 and 4 added by dry heaving. stomach ache, diarreah general malaise including some brain fog ( inability to focus on work tasks) Day 5 cold sweats on exertion, symptoms subsided on day 7. on day 9 started with light dry cough, it has progressed to the point of bronchitis now. Dr. prescribed course of prednisone, and Zithromaycin and recommends not taking second dose of this vaccine which is due on Fri, April 9th 2021
57 2021-04-06 pain in extremity Large painful and itching rash on arm.
57 2021-04-06 pain in extremity soreness in arm, no feeling well, swollen lymph glands for 2-3 days following injection; bad nausea ... Read more
soreness in arm, no feeling well, swollen lymph glands for 2-3 days following injection; bad nausea and dizziness when tying to move on Day 8 - can not get out of bed due to the nausea.
57 2021-04-06 pain in extremity My arm is very sore, it is hard to move it around at all. Thought this would stop but it has continu... Read more
My arm is very sore, it is hard to move it around at all. Thought this would stop but it has continued
57 2021-04-06 tremor Extreme stiffness that was from shoulder up into neck. Extreme nausea dizziness chills extreme head... Read more
Extreme stiffness that was from shoulder up into neck. Extreme nausea dizziness chills extreme headache and fatigue. for 7 days. Would never go completly go away and would intensify and start again severely making it impossible to leave the house. On day 7 and 8 still nausea with diarhea. The heaasche dizziness and brain fog were from days 4-7 Shaking and delayed movement of legs numbness around lips and tongue on day7 Was told noone knew what to do and just drink water. Awful to be this sick for one week.
57 2021-04-07 feeling hot, numbness Face seemed to be numb an hour after shot for about 2 hrs and then face started to feel normal, also... Read more
Face seemed to be numb an hour after shot for about 2 hrs and then face started to feel normal, also a mild headache at the time which went away as face started feeling better. Hands also became very red and hot.
57 2021-04-07 feeling hot On the evening of the vaccine, I noticed that my body was red and splotchy. The next day, I was ver... Read more
On the evening of the vaccine, I noticed that my body was red and splotchy. The next day, I was very itchy and scratching was painful. Yesterday - 2 days post injection - my head and entire torso was hot to the touch, extremely itchy and painful to scratch. I also noticed that where my bra was rubbing, it was extremely painful. Last evening, I took a Benadryl to help with itchiness. This morning, I have small blister-like patches all over my torso.
57 2021-04-07 numbness On Wednesday April 7, 2021 client received her second dose of Pfizer COVID vaccine (LOT # EW0150, EX... Read more
On Wednesday April 7, 2021 client received her second dose of Pfizer COVID vaccine (LOT # EW0150, EXP 7/2021) at approximately 3:08pm. Per EMT report, he was called over to the parking lot d/t client stating she was feeling a sensation of "numbness in her left arm" after receiving her second dose. Client stated to EMT she experienced no reaction from her first dose. Client was brought back to Observation Area where she was seated in a chair and vitals were taken. Vitals at 3:27: BP: 134/68, HR: 78, O2 sat: 97%. After five minutes client stated to EMTs she felt no other symptoms and that her numbness "was improving." At 3:30pm, EMTs offered client water but she refused. Client stated to EMTs she desired to leave as she stated she felt her symptoms were subsiding. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was educated by EMTs on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site with a steady gait at approximately 3:40pm.
57 2021-04-07 tremor 24Mar2021 Went to see Neurologist now have optical neuritis and balance issue.; 24Mar2021 Went to se... Read more
24Mar2021 Went to see Neurologist now have optical neuritis and balance issue.; 24Mar2021 Went to see Neurologist now have optical neuritis and balance issue.; 19Mar2021 headache and shakiness; 19Mar2021 headache and shakiness; This is a spontaneous report from a contactable consumer (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot Number: Er2613), via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (with no symptoms) and known allergies to Flagel, aspirin, dairy, oats, tomatoes, and garlic. The patient did not have COVID prior to the vaccination. The patient had no other vaccine in four weeks but had other medications in two weeks (unspecified). On 19Mar2021 at 07:00 AM, the patient experienced headache and shakiness. On 24Mar2021, she went to see a Neurologist and now had optical neuritis and balance issue. She was the scheduled an MRI. The patient wanted to know if she should get her second dose. The patient was not COVID tested post-vaccination. The patient received no treatment for the events. Outcome of the events was not recovered.
57 2021-04-08 burning sensation Face became red , burning sensation, light puffy swelling feeling 20 min after shot. Zyetac given si... Read more
Face became red , burning sensation, light puffy swelling feeling 20 min after shot. Zyetac given side effects went away. Returned 6 hrs later same symptoms benadryl given. No further issues
57 2021-04-08 hot flush Client received first dose @12:18 pm, felt flushed with tunnel vision @12:54 pm. Client's vital si... Read more
Client received first dose @12:18 pm, felt flushed with tunnel vision @12:54 pm. Client's vital signs stable, no symptoms by 1:04 pm. Able to go home by 1:14 pm.
57 2021-04-08 pain in extremity Sever headache: sever body aches: redness, swelling, itching, and heat at injection point. Left arm ... Read more
Sever headache: sever body aches: redness, swelling, itching, and heat at injection point. Left arm severe soreness. Chills and small amount of diarrhea.
57 2021-04-08 pain in extremity INTENSE PAIN IN THE HAND OF THE LEFT ARM, IMMOBILITY OF THE HAND AND FINGERS. EMERGENCY ADMISSION
57 2021-04-08 pain in extremity Pt. had intial sore arm soon after vaccine. She developed a large swollen supraclavicular lymph nod... Read more
Pt. had intial sore arm soon after vaccine. She developed a large swollen supraclavicular lymph node 1 day after shot. She also has headache.
57 2021-04-08 tenderness The next morning after receiving the vaccine the injection site was red, swollen and painful to touc... Read more
The next morning after receiving the vaccine the injection site was red, swollen and painful to touch. Today (three days after receiving the vaccine) woke up and the redness has spread to another spot on my arm and itches and still painful to touch.
57 2021-04-09 feeling hot Patient felt the hives on her face that she already had upon presentation appeared worse. Her face f... Read more
Patient felt the hives on her face that she already had upon presentation appeared worse. Her face felt warmer noting her upper lip felt the most warm. This occurred soon after injection was given. No lip or tongue swelling, no SOB, chest pain, palpitations or other symptoms noted.
57 2021-04-09 pain in extremity my gums were slightly inflamed or puffy, particularly the upper gums; Left side of face slightly swo... Read more
my gums were slightly inflamed or puffy, particularly the upper gums; Left side of face slightly swollen/left side of face was slightly puffy; full muscular control of my face; Polyneuropathy symptoms were stirred up; Throat felt slightly itchy; Left upper forearm pain; Pain upper arm; This was a spontaneous report from a contactable consumer, the patient. A 57-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration in left arm on 06Mar2021 at 08:11 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy, asthma (very mild), polyneuropathy from Aug2020 and ongoing, anxiety, and sinusitis. Patient was tested positive for Covid in Jan, she tested positive on 14Jan2021. This was a mild case and antibodies were confirmed afterwards. It was 7 weeks after she tested positive that there were confirmed positive antibodies. Concomitant medications included bupropion (MANUFACTURER UNKNOWN); gabapentin (MANUFATURER UNKNOWN), guaifenesin, pseudoephedrine hydrochloride (SUDAFED) (MANUFACTURER UNKNOWN) and Wilson's Wash (MANUFACTURER UNKNOWN). The patient previously took theophylline for asthma and experienced swelling face and pharyngeal swelling. On 06Mar2021, the patient experienced throat felt slightly itchy, left upper forearm pain, pain upper arm. On 09Mar2021, the patient experienced polyneuropathy symptoms were stirred up. On 12Mar2021, the patient experienced full muscular control of my face, at 05:30 she experienced left side of face slightly swollen/left side of face was slightly puffy. On 14Mar202, the patient experienced my gums were slightly inflamed or puffy, particularly the upper gums. It was reported that patient received the 1st dose on 06Mar2021 and Friday on 12Mar2021, when woke up, the left side of face was slightly puffy, face looked normal and had full muscular control of face, but it just went form the jaw all the way to the eyelid only on the left side. On 14Mar2021, gums were slightly inflamed or puffy, particularly the upper gums. Patient called neurologist the next day, 15Mar2021, went to see him on Thursday to have him take a look. He confirmed there was no muscular damage, but the left side of my face when poked was duller than the right side. It started 2 weeks ago today, it hasn't gotten worse and hasn't gotten better. Patient was scheduled to get 2nd dose this Sunday but going to hold off because she was concerned about this side effect. Patient tried using Claritin and Benadryl to see if that might make it go away, but it didn't. Her face does not look disfigured in any way. It's not getting worse or better. Just staying the same. She also has polyneuropathy. She got it in Aug2020 from a needle biopsy of the lymph node in her left breast. It was supposed to decrease over time over one or two years. Prior to having Covid she didn't think about it most days. When she got Covid it stirred up the symptoms. When she got the vaccine it also stirred up the polyneuropathy symptoms. She started to notice it being stirred up 09Mar2021. Her neurologist said it was her immune system working and it was aggravating it. On 12Mar2021, she had the left face thing, which was completely new, she never had symptoms like that. It has been 2 weeks and hasn't gotten worse, hasn't gotten better. She was super healthy. She doesn't drink, doesn't smoke, and exercises every day. On the needle biopsy last year by the radiologist in Aug2020. She got small fiber polyneuropathy, which causes tingling prickly sensations in different parts of the body. It was acute form and will go away in a year or two. By Jan it had minimized, but Covid stirred up the symptoms. The neurologist said any illness can cause polyneuropathy symptoms to increase. Then they started to subside. When she got the vaccine, by that Tuesday the polyneuropathy symptoms were greatly aggravated, by the 09. She was confident that they would resolve and have lessen in severity. The clinical outcomes of the left side of face slightly swollen, throat felt slightly itchy was not resolved, for the throat felt slightly itchy, left upper forearm pain was resolved on 06Mar2021, for the pain upper arm was resolved on 07Mar2021 and for event Polyneuropathy symptoms were stirred outcome was resolving. No follow-up attempts are possible. No further information was expected.
57 2021-04-09 pain in extremity fatigued; sore arm; This is a spontaneous report from a contactable consumer. A 57-years-old non-pre... Read more
fatigued; sore arm; This is a spontaneous report from a contactable consumer. A 57-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9266), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 as single dose for covid-19 immunisation. The patient medical history not reported. Concomitant medication was Lipitor. Patient historical vaccination was first dose of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) on 01Feb2021 in Left arm for covid-19 immunisation. Patient indicated on 22Feb2021 evening they felt fatigued (mild) and was not sure if it was from the vaccination on18Feb21 also experienced sore arm. No treatment received. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovering.
57 2021-04-09 tingling Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported arm... Read more
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported arm and hand tingling within 1 minute of the injection. She was provided ice for her arm and asked to stay in the store for observation for 30 minutes. She reported 30 minutes later that the ice had improved her symptoms. She reported no numbness, only tingling. Patient successfully left the store 30 minutes after her injection and instructed to continue to ice as needed.
57 2021-04-10 weakness Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symp... Read more
Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symptoms: lack of taste, muscle pains in lower extremities/back/arm, ringing ear, itching, throat narrowing/shortness of breath, weight loss, extreme fatigue and weakness for several days; brain fog, dizziness, difficulty swallowing/sleeping.
57 2021-04-10 tingling, pain in extremity, numbness, hypersensitivity of all senses, burning sensation, myelitis transverse Beginning January 15, 2021, I began experiencing symptoms of transverse myelitis: Pain in the lower ... Read more
Beginning January 15, 2021, I began experiencing symptoms of transverse myelitis: Pain in the lower back, sharp shooting pain down the legs, numbness, tingling, burning sensation in legs and feet, increased sensitivity to touch, cold and heat; weakness in the lower limbs, bladder and bowel problems. The symptoms were crippling and nothing helped control them. Finally on March 23, 2021, the symptoms began to subside.
57 2021-04-10 tingling Shooting pains like needle jabs in my neck proximal to skull attachment sites, along SCMs and in lig... Read more
Shooting pains like needle jabs in my neck proximal to skull attachment sites, along SCMs and in ligaments. Lasted for a week. Was intermittent during the daytime.
57 2021-04-10 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS SITTING DOWN WHEN SHE FAINTE... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS SITTING DOWN WHEN SHE FAINTED. SHE HIT HER HEAD LIGHTLY. SHE WAS UP IN A COUPLE OF SECONDS. WE CALLED 911 BUT AFTER CHECKING HER THEY LET HER STAY FOR A FEW MORE MINUTES AT THE STORE, SITTING DOWN. WE GAVE HER WATER AND AN ICE PACK FOR HER HEAD, AND WHEN SHE SAID SHE WAS FINE, WE LET HER GO HOME.
57 2021-04-11 breast pain First dose received 4March2021, mild discomfort in right breast. Second dose received 2April2021, e... Read more
First dose received 4March2021, mild discomfort in right breast. Second dose received 2April2021, extreme discomfort in right breast. Had lymnodes removed from right arm in 2005, no cancer. Multiple breast surgeries on right breast. Right arm had two knots near the lymnode area and very painful in my breast breast after the second vaccine. Still experiencing mild pain and soreness in right breast. Scheduled mammogram on 21April.
57 2021-04-11 pain in extremity I had absolutely no pain nor any reaction from first Pfizer shot. A few hours after the second shot... Read more
I had absolutely no pain nor any reaction from first Pfizer shot. A few hours after the second shot, my arm hurt. A little later I felt achy, but still was up for going out to dinner with friends. Woke up that night with pretty big pain in injection arm. It was a little less than the pain when I got the actual injection. Next morning I was achy all over and arm still hurt pretty bad. Started Tylenol (3x in 24 hours - - which I never take) and had a day of pjs in bed. Achy most of the day. No fever though. Woke up today with no pain at all in injection arm and no body aches! All was very manageable, but wanted to report for science. #thankyouscience
57 2021-04-11 tremor Day after woke up In a fog. Dizziness. Tremors.
57 2021-04-12 weakness, muscle spasms Headache-immediately lasting 4-7 days intermittently Fever-4 days Nausea (Weakness and Dizziness) M... Read more
Headache-immediately lasting 4-7 days intermittently Fever-4 days Nausea (Weakness and Dizziness) Muscle spasms and joint pain Fever -4 days Chills Fast heartbeat Cotton mouth/tightness in throat Chest tightening Tiredness Injection site pain, swelling of arm glands/nodes
57 2021-04-12 numbness, tremor Second day after shot - severe headache, extreme pain in joints, and later shaking. Day 10- in the ... Read more
Second day after shot - severe headache, extreme pain in joints, and later shaking. Day 10- in the arm where the shot was given feeling of numbness that circled around the arm.
57 2021-04-12 numbness Numbness to left side of face (eye socket and upper cheek) post vaccination. Started after returning... Read more
Numbness to left side of face (eye socket and upper cheek) post vaccination. Started after returning home from vaccine appointment. Patient reported temporary numbness improvement with diphenhydramine.
57 2021-04-12 night sweats Diarrhea, nausea, body aches, night sweats, pain in injection site right arm, headaches, and fatigue... Read more
Diarrhea, nausea, body aches, night sweats, pain in injection site right arm, headaches, and fatigue, ongoing for more than 5 days. Day 6 Right now and some of my symptoms have subsided but I still have abdominal pain, nausea, less diarrhea and fatigue. My muscles feel better.
57 2021-04-12 pain in extremity I RECEIVED THE FIRST DOSE OF PFIZER VAC ON 3/27, I HAD THE NORAMAL ARM PAIN AND CONGESTION AND HEAD... Read more
I RECEIVED THE FIRST DOSE OF PFIZER VAC ON 3/27, I HAD THE NORAMAL ARM PAIN AND CONGESTION AND HEADACHE ON 3-28, ON 4-1 I STARTED HAVING CHILLS AND A RASH APPEARED ON LEFT SIDE OF MY BACK, BY SUNDAY 4-4, THE RASH HAD SPREAD FROM MY BACK AROUND MY LEFT SIDE AND ONTO MY STOMACH, I WENT TO URGENT CARE ON 4-4 AND WAS DIAGNOSED WITH SHINGLES. I RETURNED TO URGENT CARE AGAIN ON 4-11 BECAUSE IT WAS NOT GETTING BETTER , AND THEN A VIDEO CONFERENCE WITH MY DR. OFFICE ON 4-13
57 2021-04-12 tremor Anxious, shaky BP 180/100, 130/92, HR 98, O2Sat 98 1:03pm pt. felt ok to leave.
57 2021-04-12 unresponsive to stimuli While walking a patient from urgent care to radiology at approximately 1632 on 4/12/21, I witnessed ... Read more
While walking a patient from urgent care to radiology at approximately 1632 on 4/12/21, I witnessed another patient (patient affected by event) fall to the floor by the pharmacy window. I rushed to the patient's side and began an initial assessment of airway, breathing, and circulation. No active bleeding or head injury detected. The patient was lying to her right side and appeared to be unconscious. No response when called or tapped on the shoulder several times. Patient's eyes appeared to be half-open without apparent movement. I asked for assitance from nearby security officer to call an ERT. Approximately 30-45 seconds into event, patient's daughter appeared on scene and attempted to call patient without response. While daughter assisted with supporting the patient's head, the patient suddenly took a deep breath and appeared to blink eyes several times (approx 5 seconds) before returning to previous unconscious state. No response when called by daughter throughout event. Another staff member appeared on scene at this time and recorded the second unconsciousness episode, which lasted for 90 seconds. ERT, urgent care providers, and other staff members were on scene at this time. 911 called. Vital signs taken and further assessments conducted. A pillow was placed under the patient's head and cervical collar applied. Patient appeared to be confused and in and out of consciousness at this moment. Patient was not able to identify name, date of birth, or current location but did state she had pain in her neck when asked in Spanish by another urgent care staff member. 911 staff on site at approximately 1645. Patient left in stable condition via ambulance gurney to higher level of care, accompanied by daugher and paramedics.
57 2021-04-13 breast pain After being on menopause for two years (no menstruation), I started with all signs of ovulation: vag... Read more
After being on menopause for two years (no menstruation), I started with all signs of ovulation: vaginal secretion, breast sensitivity and pain, acne. And after almost two weeks I had the feeling I was going to start my period. And I noticed pink after urinating and apparently a period is starting (menstruation). After 3 years of no menstruation.
57 2021-04-13 mild one side paralysis pt got vaccine in AM of 4/1/21- she said she then went to sleep a few hours later and slept x 18 hou... Read more
pt got vaccine in AM of 4/1/21- she said she then went to sleep a few hours later and slept x 18 hours. when she awoke the next day she had left arm and left leg weakness. she was seen in provider office and her weakness was noted- shse was sent for stat non-contrast CT of brain which was negative for acute ischemic event. Her neurologist was informed, the pt was stasrted on daily baby aspirin and she is scheduled for an MRA/MRI of brain/neck and f/u appt w/neurology
57 2021-04-13 pain in extremity Usual symptoms on day 2 sore arm, achy joints. Day 5 sore throat, achy joints and fatigue. Day 6 ext... Read more
Usual symptoms on day 2 sore arm, achy joints. Day 5 sore throat, achy joints and fatigue. Day 6 extreme dizziness/vertigo, nausea, diarrhea, chills, achy joints and fatigue.
57 2021-04-13 pain in extremity The following day after the vaccine, I woke up with a headache, and tenderness in my left armpit, ba... Read more
The following day after the vaccine, I woke up with a headache, and tenderness in my left armpit, back of arm and neck. Was only able to raise my arm 1/4 way. No relief with Aleve. The symptoms worsened as the evening progressed. Took Tizanide 5 mg. Mild relief. Awoken in the middle of the night with excruciating pain in the left arm, neck and shoulder. Applied Ulta Tiger Balm, placed a heating pad to the areas and took Aleve. Received some relief. Mild to moderate pain continued the rest of the day despite continuing with the same regiment. Once a gain I awoke with increased pain, now it was radiating to my scapula, upper back and left side of chest. I sat up in the bed and continued with the regiment.
57 2021-04-14 weakness Vomiting, headache, dizziness, weakness, pain at injection site
57 2021-04-14 numbness, tingling, pain in extremity After 30 mins, my lower lip started tingling and became numb. In 15 mins, my left side of my face ... Read more
After 30 mins, my lower lip started tingling and became numb. In 15 mins, my left side of my face was numb and tingling. It then spread to the right side. My throat started itching and then my ears began itching. I then got a headache. I contacted my primary dr office. They would not see me because they didn't give the shot. I text my allergy office. They told me to take Benadryl and keep my epi pen close. I did. After an hour and a half, the symptoms didn't improve so I decided to go to the Urgent Care. By this time, the numbing/ tingling feeling was going down my arms and back. They said my blood pressure was a little high and I had a slight fever, 99,8. I felt awful. The urgent care said there wasn't anything they could do but recommend continual use of benadryl and ibeprophen. I went home and rested. The numbness and tingling lasted until around 5:00. The itchy throat/ears and bad headache continued until I went to sleep around 9:30. I slept through the night. All symptoms were gone except for a sore arm, in the morning.
57 2021-04-14 migraine After receiving the shot, I started getting a headache within a few a hours so I ate and took 2 Tyle... Read more
After receiving the shot, I started getting a headache within a few a hours so I ate and took 2 Tylenol (500 mg each); At 9:30p that night it escalated to a migraine (I took 1 Maxalt). My blood also went up to 137/82 (it normally runs 120/80 or lower). I took another 5 mg of Lisinopril and laid on my left side to try to get it down. I fell asleep in that position with an ice pack on head. The next morning my blood pressure was back to normal. By Friday, the injection site was swollen, the size of a quail egg underneath the skin, hard to the touch, and beginning to turn red.. Today I am one week out and the swelling has gone down on the outside, the "egg" is softening," but the redness continues (that wasn't there until 2 day AFTER the injection) . Also, the redness has grown to the size of a half dollar. I called my PCP's nurse and she said it might take a couple weeks for it to go away. I'm concerned because it to itch a couple days ago and I also don't think the redness should be getting bigger at the injection site.
57 2021-04-14 pain in extremity, muscle twitching, migraine On the fourth day after the injection, I experienced blurry vision that was relatively mild over the... Read more
On the fourth day after the injection, I experienced blurry vision that was relatively mild over the course of maybe an hour. The next day, the same thing. The following day, March 25 (vaccine was 3/19) I experienced transitory vision field impairment in the left eye which came in from the left periphery. This came and went over the course of about 1-1/2 hour, including throughout the visit to my doctor. Prior to this, both my 21 year old daughter (who was vaccinated the same time as I was), experienced sudden migraines at the same time. On Saturday 3/27 I began to experience a twitch/pulse which is still happening intermittently in my left cheek. I received the second dose of the vaccine April 9th. The twitching continues. Additionally, I had sharp pain across the length of the sole of my foot that was brief. It recurred three times. I've had a thorough workout which does not indicate the source of the problem. I've begun taking baby aspirin, but experience minor bleeding if I take it more than once weekly.
57 2021-04-14 pain in extremity Weakness in arm, elbow, and wrist. Now I have no strength in my right arm. When putting pressure aga... Read more
Weakness in arm, elbow, and wrist. Now I have no strength in my right arm. When putting pressure against my hand, it shoots a pain up my right arm. Hurts to use a computer mouse with my right wrist. Hurts to turn or twist right arm now. Weakness to grab or pick up things with my right hand. Have not sought medical attention yet. Waiting to see if it wears off. Went to the Chiropractor and nothing is out of place.
57 2021-04-14 pain in extremity Severely swollen lymph nodes in left arm pit arm of the injection also swollen lymph nodes on collar... Read more
Severely swollen lymph nodes in left arm pit arm of the injection also swollen lymph nodes on collarbone at neck. Painful to put my arm down or lift anything with my left arm, stabbing pain in lymph nodes in armpit, feels like an underwire stabbing me in the armpit Going on day three. Pain Keeps me awake at night.
57 2021-04-14 pain in extremity Severe pain in lower back/pelvis area shooting down around hips to legs. Starting around March 23rd ... Read more
Severe pain in lower back/pelvis area shooting down around hips to legs. Starting around March 23rd which increasing got worse. Unable to use 2 aleve and tylenol along with stretching, ice packs and epsom salt soaks to ease pain. Went to see primary on 4/8. Ordered blood work after initial exam. Blood work came back inconclusive. Xrays of the lumbar and spine were ordered. Showed extensive scacroilac inflamation/mass on the left side. Was ordered prednisone for 14 days which starts today.
57 2021-04-14 pain in extremity 4/2 ~4/3: No daily exercised (30 pushups in the morning) during these two days. 4/4/2021: Resumed da... Read more
4/2 ~4/3: No daily exercised (30 pushups in the morning) during these two days. 4/4/2021: Resumed daily exercise, and walked a few miles (usually 2-3 times weekly)? leg and butt pain April 5-7: stiff neck symptoms: back, right arm, shoulder, and neck pain, April 8-11: stiff neck kind of symptoms: back, left shoulder, and neck pain April 10-11: stiff neck kind of symptoms (back, left shoulder, and neck pain) + injection site pain (left arm) April 11-13: continued left arm injection site pain. April 14: waked up with less left arm injection site pain. After daily pushups, continued left arm injection site pain. April 15: waked up with less left arm injection site pain,
57 2021-04-14 seizure, weakness 5:30AM 3/6/21 STARTED WITH NAUSEA, VOMITING AND HEADACHE DYSPNEA -- STOPPED AT DUNKIN DONUTS AND DRA... Read more
5:30AM 3/6/21 STARTED WITH NAUSEA, VOMITING AND HEADACHE DYSPNEA -- STOPPED AT DUNKIN DONUTS AND DRANK COFFEE WITHOUT IMPROVEMENT. SHE PULLED OVER AND CALLED 911 AND REPORTS PASSING OUT IN THE CAR. EMS ARRIVED AND HAD TO BREAK THE WINDOW TO EXTRACT HER. MEDICAL CENTER EMERGENCY ROOM. SHE HAD TWO WITNESSED SEIZURES WHILE IN THE EMERGENCY AND WAS ADMITTED AND DISCHARGED ON 3/8/2021. WEAKNESS AND SEIZURE WAS HER DIAGNOSIS UPON DISCHARGE. NEUROLOGIST FOLLOW UP WAS YESTERDAY AND SHE IS BEING RX LAMICTAL. EEG SCHEDULED 5/11/21. HISTORY OF SEIZURE TWO YEARS AGO. HER NEUROLOGIST SAID THAT THE VACCINE COULDVE PROMPTED PRE EXISTING CONDITION.
57 2021-04-15 hot flush, pain in extremity Early morning after second dose: severe pain in left side of neck progressing up to forehead causing... Read more
Early morning after second dose: severe pain in left side of neck progressing up to forehead causing severe headache, dry hacking cough, difficulty breathing. Saw PCP, Dr that day and was prescribed steroids to assist with breathing and cough syrup. Next day same side effects but meds helping, nervous energy. Note: had nervous energy after first dose on first few days as well. April 10, 2021, four days after second dose: phlegm building up in head and chest, coughing with little phlegm, so thick it causes choking with eyes and nose running, leading to loss of breath and almost loss of consciousness, severe headaches, continued neck pain with swelling appears to have radiated from left arm injection site, continued difficulty breathing, severe nausea and stomach cramping, body aches especially in legs, hot flashes mixed with chills (back and forth.) No fever, however. Contacted PCP. As of April 16, 2021, side effects continue with weakness in limbs, extreme lethargy and sleepiness, but restless sleep that's interupted by coughing/choking.
57 2021-04-15 pain in extremity, migraine, tremor Sore arm, sore armpit, chills/shaking, extreme fatigue, fever reached 102.3 before going to bed on d... Read more
Sore arm, sore armpit, chills/shaking, extreme fatigue, fever reached 102.3 before going to bed on day of vaccination. Day after(4/11/2021) fever hovered around 100.5 all day, had a massive headache on top of my head, couldn?t keep anything down the entire day, arm was still very sore, slept a good part of the day. On 4/12/2021 I woke up with a migraine on my left side, arm was still sore all day, fever was 99.5, worn out/tired until mid afternoon. Was able to eat today. On 04/13/2021 my arm was slightly sore and I had muscles in my body that hurt. For example my right cheek was sore. On 04/14/2021 no lingering symptoms.
57 2021-04-16 muscle spasms Symptoms began around 8 pm with sudden fatigue and continued throughout the night, with something ne... Read more
Symptoms began around 8 pm with sudden fatigue and continued throughout the night, with something new every time I woke up: chills, then fever, severe left leg cramp. Tachycardia was the last, starting just before 3am; resting pulse rate around 115 (measured with a home pulse oximeter) whether lying down or sitting up, throughout the rest of the night and into the next morning. Note, I had COVID-19 (symptom onset 12/07/2020), relatively mild.
57 2021-04-16 pain in extremity Dose 1 - extremely sore arm for 1 week, nausea, fatigue Dose 2 - extremely sore arm and COVID arm ra... Read more
Dose 1 - extremely sore arm for 1 week, nausea, fatigue Dose 2 - extremely sore arm and COVID arm rash appearing 2 days later, headache, fatigue
57 2021-04-16 tremor, tingling The patient had reported to the site for her second shot of COVID. During her assessment she did not... Read more
The patient had reported to the site for her second shot of COVID. During her assessment she did not mention any adverse reactions with the first shot. She did mention a hx of pseudoseizures during blood draws. She mentioned that her husband was waiting in the paring lot for her in case she had any reactions after her second shot, and that she would know during the first 15 minutes if she would have one or not. After receiving her vaccination, the patient reported to the observation area. The nurse in the observation area had checked on her, and in response the patient mentioned that her arm felt tingly. The nurse asked if this happened during her first shot, and she said yes. The patient then stated that she felt shaky. The nurse signaled for the medics to assess her further. The medics transferred as a two assist, as the patient was unable to support her own weight. The patient was then brought to a private area, and her husband was called by one of the nurses to come into the site per the patients request because he knew what to do for her when she had pseudoseizures. Medics maintained the patients safety throughout the event. As the husband approached the entrance of the vaccine site, he was escorted to the private area where his wife was. Upon reaching his wife, the patient began to shake and breathing hard. The husband stated that she hadn't had any of these pseudoseizures in awhile and that it must have been from the shot. The medics advised bringing her to the hospital at that time for further evaluation and support, and the husband agreed.
57 2021-04-16 tremor Approximately seven minutes after my injection, I tasted a metallic taste in my mouth and I began ... Read more
Approximately seven minutes after my injection, I tasted a metallic taste in my mouth and I began experiencing extreme rapid heartbeat , extreme shakiness and extreme panic and anxiety.. I quickly alerted a nurse who had me lay down and took my vitals and gave me something to eat and drink. They observed me for an additional half hour and then released me as I was feeling mostly better but still shaking a little.
57 2021-04-17 weakness Woke up day after vaccine with trouble breathing; shortness of breath. Tried old inhaler, allergy ta... Read more
Woke up day after vaccine with trouble breathing; shortness of breath. Tried old inhaler, allergy tablet and deep breathing. Nothing helped but sleep. Felt light headed and faint, and only resting helped. Felt less gasping for breath in the evening, went to bed early, and awoke today/Sunday with the same gasping of breath, feeling weak, light headed and unable to breathe properly.
57 2021-04-17 cold sweat Patient received her vaccine and during the 15 minute observation period, her husband called us over... Read more
Patient received her vaccine and during the 15 minute observation period, her husband called us over. She was extremely sweaty, had clammy hands, eyes were fading in and out, and appeared as if she was about to pass out twice. No reports of trouble breathing. Called 911, stayed with patient until the paramedics came who then escorted her.
57 2021-04-17 feeling jittery Second vaccine fever and frequent urination and jittery feeling; Second vaccine fever and frequent u... Read more
Second vaccine fever and frequent urination and jittery feeling; Second vaccine fever and frequent urination and jittery feeling; Second vaccine fever and frequent urination and jittery feeling; This is a spontaneous report received from a contactable consumer (Patient). A 57-year-old female patient (not pregnant) received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 11:00 (Lot Number: ER8737) at single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic. Medical history was none, no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported; biotin taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 (lot number: EN6206) on 08Mar2021 04:00 PM for covid-19 immunization and experienced sore arm. The patient experienced second vaccine fever and frequent urination and jittery feeling on 31Mar2021 12:00. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was not recovered. Seriousness criteria was no. No follow-up attempts are needed. No further information is expected.
57 2021-04-17 numbness, pain in extremity tip of left ring finger turned white and numb/finger was completely white and the rest of her hands ... Read more
tip of left ring finger turned white and numb/finger was completely white and the rest of her hands were blue and red and white and yellow; tip of left ring finger turned white and numb; her finger felt funny; Reynauds phenomenon; sore arm; fever; chills; headache; swollen lymph node in the armpit of the arm she got her Covid 19 vaccine in; swollen lymph node started with a sharp pain and it's very sore; left foot, it was pulsing and throbbing all night; feet were modeled red, blue; feet were modeled red, blue; very sick; needed her glasses trying to give her primary care doctor's phone number; has something like gout in her foot; The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 57-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0150; expiry: 31Jul2021), via an unspecified route of administration in left arm on 31Mar2021 01:30 as single dose for covid-19 immunisation. The vaccination facility type was a warehouse. The vaccine was not administered at a military facility. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks) and no following prior vaccinations. Medical history included covid-19 in Nov2020. The patient had no concomitant medications. The patient had the first dose of bnt162b2 on 31Mar2021 and 12 hours later (on 01Apr2021), sore arm, fever, chills and headache. Got a swollen lymph node in armpit, same arm as injection left side, today tip of left ring finger turned white and numb. She thinks it was Reynauds phenomenon. The patient called and told nurse in her doctor's office and they said if it was painful, it could be a pain clot. It was painful at first, that lymph node started 24 hours later with a sharp pain, and then she just assumed it could be a lymph node. Swollen lymph node started with a sharp pain and it was very sore. The nurse told the patient to call Pfizer. The patient was fine until the tip of her finger happened. The patient said If it was painful it could be a blood clot, would need an x ray and asked if did the shot cause this. The complete ring finger left hand, the patient looked it up and it said it could happen to her feet and she looked, and her feet were modeled red, blue it was bizarre. Never happened before. The patient was not happy about getting the vaccine, she already had covid in November of last year (2020). The patient wouldn't have called if it wasn't for her finger. Not just her feet, her hands got like this too. The patient didn't want to get the second shot. The patient asked if there was any information or mandate on timing information for the second dose, should she needed to postpone it. The patient asked if what was the efficacy after first dose as she felt like she was immune because she had the virus and now the vaccine. She was very hesitant to get the Covid 19 vaccine. She thinks her body created Covid 19 antibodies. A couple days ago she was very sick. The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows (in 2021). Even putting on deodorant she can tell it's there, it was very sore and there's a lump. Today (on 01Apr2021), she noticed the tip of her finger got white it was numb. She looked it up online and she thinks it was Reynaud's phenomenon. She has a picture if Pfizer needed it. The finger was on the same arm that she received her vaccine in. It was the ring finger on left hand. Once it started happening her finger felt funny and felt numb. She put her finger under warm water. She reported that the white color was maybe a third of the way down towards her knuckle. She was asking if this was normal or has this been reported. She had called her doctor today and spoke with the nurse who told her to call the CDC and report her symptoms. She needed her glasses trying to give her primary care doctor's phone number. The patient wanted to add that she has something like gout in her foot and on that side too, the left foot, it was pulsing and throbbing all night. She's had this pain in her left foot, she thinks its gout because it was all the symptoms of gout and she had it for a while, it hurts off and on but that night it was hurting and throbbing. She has not been diagnosed with gout in that left foot. She still has a headache but today she felt good except for her finger turning white and going numb. The lymph node in her armpit hurts. Her doctor's nurse told her if its painful to the touch it could be a blood clot so she was nervous about that. The tip of her finger was completely white and the rest of her hands were blue and red and white and yellow. She reported that her finger was back to normal now. She didn't want to get too inoculated since she also had the Covid 19 virus. The events did not require visit to emergency room nor physician office. The outcome of the events was unknown for thrombosis, Raynaud's phenomenon, erythema, cyanosis, illness, visual impairment, and gout while for the remaining events was recovering.
57 2021-04-17 numbness Numbness of left jaw, left cheek, left ear, left leg
57 2021-04-17 muscle spasms After the first shot, I was lightheaded and dizzy; After the first shot, I was lightheaded and dizzy... Read more
After the first shot, I was lightheaded and dizzy; After the first shot, I was lightheaded and dizzy; muscle spasms in my chest, back, left calf and neck for over 24 hours/The chest and leg spasms were so painful; The pain was not constant and was sporadic; The evening of the 27th I was awakened out of my sleep; This is a spontaneous report from a contactable other hcp for herself. A 57-years-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration (at the age of 57-years-old), administered in Arm Left on 06Mar2021 09:00 (Batch/Lot Number: EN6202) as SINGLE DOSE, dose 2 via an unspecified route of administration (at the age of 57-years-old), administered in Arm Left on 27Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included telmisartan. The patient was reported to have allergy to lisinopril. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with covid-19 prior or post to the vaccination. Patient reported that after the first shot, she was lightheaded and dizzy for about an hour after. After the second shot, she experienced muscle spasms in her chest, back, left calf and neck for over 24 hours. The pain was not constant and was sporadic. The chest and leg spasms were so painful on 28Mar2021 02:00. And the evening of the 27th she was awakened out of my sleep. Treatment was not received for any event. Events were considered non-serious as reported. Outcome of all events was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-04-17 tremor, muscle twitching, bell's palsy, tingling breathing out; cheeks, lips, and mouth started quivering/trembling; cheeks, mouth and lips started q... Read more
breathing out; cheeks, lips, and mouth started quivering/trembling; cheeks, mouth and lips started quivering and twitching; swelling sensation on her left side of her face; left cheek area felt swollen and tingly; pressure around the eye sockets; Could this be a sign of Bell's Palsy, and is it likely that she develop Bell's Palsy?; This is a spontaneous report from a contactable consumer (reporting for herself). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in left arm on 30Mar2021 14:00 at a single dose for covid-19 immunization. Medical history included has back issues, but nothing serious probably for about 7 years and patient stated that she had a Pilates injury and after that her back has never been the same; and patient stated that she was pretty healthy, adding that she was allergic to sulfa, cow's milk, wheat, and almond. Family medical history relevant to events reported included mom has osteoporosis, and severe dry eye syndrome. The patient's concomitant medications were reported as she doesn't take any regular medicines but she does take regular supplements and herbs and stated that she was very lucky. Patient stated that Pfizer COVID-19 vaccine was the he one she trusted the most and she doesn't want to die from COVID if she gets it. Patient received her dose in her left arm, at the time of administration, on 30Mar2021 14:00, she was breathing out, then her "cheeks, lips, and mouth started quivering/trembling and it was definitely noticeable". Patient further stated that while it was being administered her cheeks, mouth and lips started quivering and twitching. She also reported that immediately afterward (30Mar2021), she experienced a swelling sensation on her left side of her face, "kind of how it feels when you have novocaine, but no visible signs of swelling or drooping". Her left cheek area felt swollen and tingly. She stated that it felt swollen but it didn't look swollen, like when you go to the dentist. She also experienced pressure around the eye sockets. She added that both areas under eye sockets felt a little bit weird, tight or something but not like a pain, hard to describe. All of these symptoms resolved within a few hours, and 24 hours later she's "pretty much back to normal". The pressure around eye socket, lasted for a few hours; while trembling and quivering only happened when the shot was being administered, and 24 hours later, she was pretty much back to normal. Patient asked if this has this been reported before and if she should she get her second dose. Patient stated if this could this be a sign of Bell's Palsy, and was it likely that she develop Bell's Palsy (30Mar2021). Patient stated that all her family have all received their doses and no one had this kind of reaction. She wanted to take the second vaccine, just doesn't want to have a stroke or heart attack or anything like that. She stated that all of her events are completely gone except she still has a little bit of swollen feeling left in her cheek on a scale of 1-5 with 5 being the worst, she would say it is a 1, its pretty much gone, the swollen feeling. She stated that provider was aware of the events because she called and told her yesterday. Her family got their vaccines either moderna or Pfizer and have had no issues, other than typical ones such as forearm, a little bit of nausea, or fever but nothing like what the caller has experienced. She was the only one in her family that has had this issue. She did not have any kind of rash, no fever nausea or headache, and stated it was just like getting her flu shot. The patient did not require emergency room and physician office visit. The event swelling sensation on her left side of her face was recovering. The outcome of the other events reported was recovered on 31Mar2021.
57 2021-04-18 flushing, tingling Flushing, tachycardia, increased blood pressure, tingling in feet
57 2021-04-18 flushing Sore arm at injection site for a few days then on 3/30 began to feel flushed (red face, arms, trunk,... Read more
Sore arm at injection site for a few days then on 3/30 began to feel flushed (red face, arms, trunk, thighs), fatigue, mild headache, aches, nausea but no vomiting; took Benadryl just after shot at MD direction and an aspirin and slept first day a lot then took again on Tuesday and improved. Wednesday 3/31 felt good then Thursday evening 4/1 stated to feel like I was fighting off a cold - fatigue, nausea, flushed, slightly elevated temperature (@1 degree), chills, strong left arm injection site pain returned - iced arm, aches, mild headache, by Friday 4/2 morning still flushed red and all of above plus lungs felt icy (feeling I?ve had before having lung infection) and ozzie lungs - took Benadryl and lung icy and Ozzie feeling stopped in 30 minutes or less, continued to feel under weather with above symptoms for five to seven days. Took aspiring and Benadryl on and off during this time. Feeling better by 4/7 into 4/8/21
57 2021-04-18 numbness, bell's palsy left-sided facial numbness and left-sided mastoid pain - diagnosed with Bell's Palsy
57 2021-04-18 pain in extremity, nerve pain I experienced they "typical" side effects of pain / aching at site of injection, chills, and muscle ... Read more
I experienced they "typical" side effects of pain / aching at site of injection, chills, and muscle aches. No problem. What alarmed me was that I also had greatly increased neuropathic pain. I have chronic headaches due to cervical spine damage but these headaches were greatly magnified. All my "usual" areas of pain due to existing injuries, mostly neuropathic, were greatly magnified. Extreme low back pain started, so painful it hurt to lay on my back. The trip to get vaccinated wasn't long enough to trigger such extreme pain. I hardly slept due to the discomfort and extreme pain. I experienced transient, strange pain, such as suddenly getting very sharp, stabbing pain in one toe on my right foot that lasted for about one (1) minute. Same strange sudden sharp pain in my left knee while laying down, even though no known problems with that knee. I am physically fit. Very health conscious. A vegan. This was easily one of the most total body painful experiences I have ever had. It reminded me of one time I had a terrible bout of food poisoning, but with horrible nerve pain and without intestinal problems. I started taking Ibuprofen 800mg the next morning and slept the rest of the day and night - since I got maybe 3 hours of interrupted sleep the night of the 2nd shot. The day after that I was not 100% but much improved. By the 3rd day post 2nd shot I felt normal. Two other women in my social circle experienced similar reactions to the 2nd dose. I read that more people with neuropathic and/or arthritic conditions are reporting similar reactions, and those with auto-immune conditions. I would still get the vaccine - I would just have prepared better (doctor approved sleeping pills and pain medications.)
57 2021-04-18 pain in extremity I did have soreness in the arm and in other joints/muscles for a few days-- more on the left side of... Read more
I did have soreness in the arm and in other joints/muscles for a few days-- more on the left side of the body than the right. The reason for me filling this out is because I had heart palpitations- irregular heart beat, that went on periodically for several hours when I was at work. (Enough to kind of scare me.) I also had a momentary dizziness or unsteadiness that did not repeat itself. I had some extra tiredness, but not excessively so.
57 2021-04-18 pain in extremity Ran a fever for 48 hours; several times over 105. Extreme joint and bone ache in forearms and shins... Read more
Ran a fever for 48 hours; several times over 105. Extreme joint and bone ache in forearms and shins to the point where it was too painful to move. most side effects ended 72 hours after injection but I am still experiencing a random and lower pain level in my forearms and dizzy spells.
57 2021-04-18 pain in extremity sore arm 3 days, couldnt lift arm
57 2021-04-19 migraine Fever, aches, flu-like symptoms, me graine triggered.
57 2021-04-19 pain in extremity Deep vein thrombosis was the diagnostic from the after effects of the second vaccination. Blood cot... Read more
Deep vein thrombosis was the diagnostic from the after effects of the second vaccination. Blood cot caused leg swelling and pain They did a cat scan & MRI Treatment was being given Eliquis (4 pills a day for 7 days) (2 pills after) It is a blood thinner and must follow up with my doctor.
57 2021-04-19 seizure Nausea, vomiting, multiple falls, and ongoing multiple seizures. Patient required intubation and se... Read more
Nausea, vomiting, multiple falls, and ongoing multiple seizures. Patient required intubation and sedation. After admission, the patient experienced cardiac arrest.
57 2021-04-20 cold sweat, weakness Palpitations, Nausea, Headache, Tired, weak, cold sweat, stomach ache, thirsty.
57 2021-04-20 slurring, weakness Patient received Covid 19 Vaccine at 3pm. approx 3:14 patient states that she feels like her throat... Read more
Patient received Covid 19 Vaccine at 3pm. approx 3:14 patient states that she feels like her throat is tightening. Brought to triage area via wheel chair, as assessment is being completed, her speech appeared to be slurred. BP 197/94, HR 84, O2 100%. Request to lay down. While she is being monitored, her symptom start to improved however a visible carotid pulse was noted aprox. 3:45. 3:50 her speech start to slur again with noted weakness on the right side. Medical director informed of patient status. instructed to proceed with a call to EMS. EMS arrived at 4:16 Patient discharged to EMS at 16:32 in stable conditions. B/P 154/92, HR 80, O2 SAT 98%.
57 2021-04-20 migraine Just after 3:00 am, I was very nauseous, vomiting repeatedly while every bone and muscle ached sever... Read more
Just after 3:00 am, I was very nauseous, vomiting repeatedly while every bone and muscle ached severely. My stomach muscles went into spasms and my head felt like what i imagine a migraine feels like. The pain behind my left eye was severe. My left side of neck felt like there was a knot and it took all my strength to try to massage it felt like no blood was moving. Strangest feeling I have ever had. Went from chills to sweats every 3-4 minute cycles. Did not feel like I had a fever though. I am 0 - blood type if that matters. Day 2 all but body aches are gone.
57 2021-04-20 pain in extremity soreness in right arm extending from vaccination site to wrist. on sat within two hours and continue... Read more
soreness in right arm extending from vaccination site to wrist. on sat within two hours and continued for 24 hours. headache on Saturday following injection and continued 48+ hours.
57 2021-04-20 tingling Swollen lymph node under right are, slight tingling in right ear canal, slight tingling of exterior ... Read more
Swollen lymph node under right are, slight tingling in right ear canal, slight tingling of exterior right chin, increased hearing issues in right ear since time of vaccine.
57 2021-04-20 tingling About 8-10 minutes after first vaccine, I started feeling lightheaded, then my feet started feeling ... Read more
About 8-10 minutes after first vaccine, I started feeling lightheaded, then my feet started feeling tingly, then I started feeling a little dizzy then my heart accelerated. The accelerated heartbeat lasted no more than 10 seconds. They pulled me aside and took my blood pressure which was elevated 160/100 (it is usually 110/70). My pulse was also elevated at 100. It took about 10-15 minutes to get back to normal.
57 2021-04-20 paralysis Blood clotting, hospitalized, emergency, paralyzed, thrombosis, body not responding, therapy, treatm... Read more
Blood clotting, hospitalized, emergency, paralyzed, thrombosis, body not responding, therapy, treatment.
57 2021-04-20 tremor After the second dose, I was in the waiting area and my heart starting racing (Heart palpitation). ... Read more
After the second dose, I was in the waiting area and my heart starting racing (Heart palpitation). I approached one of the Nures and told her what was going on and the medical personnel immediately took my blood pressure which was over 233/143. I was losing my site and began to tremble. I was rushed to the emergency room at the Hospital where I received both the 1st and 2nd dose of the Pfizer Vaccine.
57 2021-04-20 unresponsive to stimuli On 4/18/21 the day after receiving my second Pfizer vaccine. I awoke fatigued and with a sore right ... Read more
On 4/18/21 the day after receiving my second Pfizer vaccine. I awoke fatigued and with a sore right arm and fever of about 99. The fatigue increased, and then included extreme thirst despite drinking plain water throughout the morning and early afternoon, then I experienced slight nausea, then syncope after attempting to sit for a few moments, after having been resting (in a prone position) around 1 pm. My husband was unable to revive me - he says my eyes were open but I was not responsive so he called 911. I regained consciousness after receiving saline via IV and then was taken to the ER for follow up testing, then released a few hours later - around 4 pm. It it likely relevant to know I had passed out from fever brought on by flu during the very harsh flu season a few years before, at the onset of influenza, although vaccinated that year for flu.
57 2021-04-21 bell's palsy Right Bell's palsy started 3 days after vaccination. I am caring for the patient as her ophthalmolog... Read more
Right Bell's palsy started 3 days after vaccination. I am caring for the patient as her ophthalmologist.
57 2021-04-21 burning sensation About two days after receiving the vaccine, pain and burning feelings from fibromyalgia returned. T... Read more
About two days after receiving the vaccine, pain and burning feelings from fibromyalgia returned. They have been under control for several years under medication, but the medication has not helped, even with an increase in dose recommended by the doctor. The pain seems to be getting worse daily.
57 2021-04-21 pain in extremity Very sore left upper arm still- 11 days post vaccination. Painful to put on and remove clothing fro... Read more
Very sore left upper arm still- 11 days post vaccination. Painful to put on and remove clothing from upper body. Some motions are A OK. Painful to sleep on.
57 2021-04-21 tingling, tenderness Started with a bump which was a little larger than a pea size. I was given the Pfizer eura at the ti... Read more
Started with a bump which was a little larger than a pea size. I was given the Pfizer eura at the time. I had no redness around the bump but was swollen and some bruzing and very sensitive to the touch with some hot sensation. Had some tingling sensation down the arm and under armpit. At this time symtons are not as they were when first given the vaccine but I do still feel some dull senstion in arm and in the shoulder area sometimes the feeling comes and goes but it's been well over a month now.
57 2021-04-21 speech disorder Extreme tiredness followed by inability to move all body parts and unable to swallow. Needed help to... Read more
Extreme tiredness followed by inability to move all body parts and unable to swallow. Needed help to sit up in bed eventually unable to speak to say that I was nauseous. Fell asleep propped up with pillows and head turned. Woke at 7 am able to move body parts but very 'out of it' - dizzy, light headed, and hard to swallow. Full day later, I was good.
57 2021-04-21 unresponsive to stimuli, flushing Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient informed immunizing pharmacist of \"fear of needles\" before vaccine was administered. Pharmacist talked to patient prior to injecting to distract her. Immediately after puncturing and prior to injecting, pharmacist noticed patient was suddenly triggered, becoming faint and confused. Nausea, vomitting, dizziness and flushing followed. All events happened within 2 minutes post-injection. EMS was called but patient refused to be brought to hospital and called a friend to pick her up.
57 2021-04-22 inability to speak, seizure like phenomena, slurring 57yo female received COVID-19 vaccine (Pfizer) dose #1 on 3/22/21 at external location. On 4/12/21, ... Read more
57yo female received COVID-19 vaccine (Pfizer) dose #1 on 3/22/21 at external location. On 4/12/21, patient received dose #2. Approximately 60 minutes later, patient reports falling from chair at work; co-worker apparently witnessed seizure-like activity and called 911 for transport to ED. Patient denies ever having a seizure in the past or being on AEDs. Per discharge note from Neurology, "Presentation with likely seizure suspected to be due to early post-stroke seizure, in setting of cortical based infarct, likely triggering acute seizure event at time of onset." Possible temporal relationship with COVID vaccine.
57 2021-04-22 weakness, numbness, tremor Rec'd 1st Pfizer covid vaccine on 4/3/2021,8:30am. Within two minutes experienced extreme faintness,... Read more
Rec'd 1st Pfizer covid vaccine on 4/3/2021,8:30am. Within two minutes experienced extreme faintness, weakness, shakiness. Placed with paramedics approx 1 hr. Husband drove me home. Legs felt very heavy, face was numb. Called TeleHealth 2pm same day. Dr said "symptons not normal, go to ER". I waited because of ER expense. By 5pm same day, I felt better. However, for over two weeks I stayed in bed. Extreme fatigue and sudden bouts of faintness. Scary. Went to Urgent Care 4/13/21. Dr. said to go to ER for more tests or primary dr. Saw Dr. on 4/15/21. Labwork on 4/16/21. Labwork and tests good. BP has abnormally spiked since shot, but normal since 4/20/21. Dr said do not take 2nd vaccine
57 2021-04-22 numbness Pt. stated, "I started feeling tingling on my upper lip and numbness on my nose, 15 min. after getti... Read more
Pt. stated, "I started feeling tingling on my upper lip and numbness on my nose, 15 min. after getting vaccinated." Vital signs done B/P 164/85, HR 86, O2Sat 97%, R 19. At 12:56pm, pt. stated, "Tingling and numbness is going away." At 1:10pm B/P was 140/78. At 1:14pm pt. reported feeling better. At 1:16pm pt. went home.
57 2021-04-22 muscle spasms Hives (neck, chest, back and arms); swollen right upper lip, swollen under eye (right); vice-like... Read more
Hives (neck, chest, back and arms); swollen right upper lip, swollen under eye (right); vice-like headache, fever of 102.8, stiff neck, neck spasms, general aches and pains.
57 2021-04-22 pain in extremity Initial Shot - Swelling in the sinus' and some dizziness, exhaustion and arm pain: Lasted for day a... Read more
Initial Shot - Swelling in the sinus' and some dizziness, exhaustion and arm pain: Lasted for day and a half Second Shot - Exhaustion, Swelling in the sinus' and dizziness, Arm Pain, Pain which appeared to be in lymph nodes (under arm and side of breast), Fever x3 days: Lasted for about a week Subsequent - I have had three periods since the vaccine. I have been in menapause for 7ish years. Periods started out minor for the first one limited bleeding and 2-3 days. The second one, about a month later, was a full week of heavy bleeding. The third one came 4 days after the last one. I am currently experiencing the third one.
57 2021-04-22 pain in extremity hurting warm leg, blood clot
57 2021-04-22 pain in extremity Pain in the arm lasted longer than the first dose. All of a sudden felt very fatigued, lethargic. ... Read more
Pain in the arm lasted longer than the first dose. All of a sudden felt very fatigued, lethargic. Only lasted 24 hours. The next day felt normal again
57 2021-04-22 tingling Upon injection I immediately felt "PINS" stabbing my hands, arms, neck, face and feet. After 30 min... Read more
Upon injection I immediately felt "PINS" stabbing my hands, arms, neck, face and feet. After 30 minutes of injection sudden severe headache (lasted 1 hour) nausea for 1 1/2 days, 1 bout of diarrhea, earaches, sinus aches intermittently for 2-3 days. (Of course the usual side effects of minor arm pain at injection site the day after injection along with chills, low grade fever and lethargy for 2 days.)
57 2021-04-22 tremor Patient had elevated blood pressure and experienced tremors following vaccine
57 2021-04-23 bell's palsy Bell's Palsy right side
57 2021-04-23 burning sensation I was asleep and awoken by burning and itching of my torso! I had a rash starting on my left side of... Read more
I was asleep and awoken by burning and itching of my torso! I had a rash starting on my left side of abdomen then spread to the right and over the next few days, spread, less densely though, to my thighs and inner arms and some on my back.
57 2021-04-23 facial paralysis, tingling Received the first dose of hte Pfizer COVID19 vaccine on 4/8/2021. Developed cold-like symptoms on F... Read more
Received the first dose of hte Pfizer COVID19 vaccine on 4/8/2021. Developed cold-like symptoms on Friday, 4/9/2021, including: congestion, headache and right ear pain. On Saturday, 4/10/2021, had persistent headache, congestion and right ear pain. Also develoepd tingling on the right side of her face. She was evaluated at Urgent Care on 4/10/2021 and recommended supportive care for right ear pain. On Sunday, 4/11/2021, developed complete paralysis of the right side of her face. She was evaluated in office on 4/12/2021 and diagnosed with Bell's Palsy based on exam - patient with complete right sided facial paralysis. She was treated with prendisone taper (prendisone 60 mg for 7 days, then 40 mg for 3 dyas, then 20 mg for 3 days) and Valtrex 1000 mg three times daily for 1 week.
57 2021-04-23 pain in extremity 4.22.21 11:15 - 11:30 AM Injection 11:45 AM - 12:00 PM - Quick onset of Vertigo and Increased Blood... Read more
4.22.21 11:15 - 11:30 AM Injection 11:45 AM - 12:00 PM - Quick onset of Vertigo and Increased Blood Pressure (Quick Rise from normal pressure to elevated blood pressure) 12:15 PM Nausea, Headache and Fuzzy Vision 1:15 PM Blood Pressure checked at a doctor's visit previously scheduled for this time. Systolic increased by 33 points and Diastolic increased by 10-15 points from my normal. 3:00 PM Quick onset of extreme exhaustion, joint and muscle pain 5:00 PM Melancholy 4.23.21 Symptoms Persisted with acute onset of hand pain on side of injection 4.24.21 Blood Pressure Normalized and most symptoms reduced, except fatigue
57 2021-04-23 tingling Traveling tingling throughout body. Tested for all other effects. No treatment, waiting for it to go... Read more
Traveling tingling throughout body. Tested for all other effects. No treatment, waiting for it to go away.
57 2021-04-24 difficulty speaking Raised red rash and welts all over head, lower face (both sides), on sides of the tongue, neck (fron... Read more
Raised red rash and welts all over head, lower face (both sides), on sides of the tongue, neck (front and back), all over torso (front and back), both arms, palms of hands, both shoulders, and upper thigh (groin area). Smallest spot was the size of a pencil eraser, largest spot the size of a silver dollar. Extremely itchy. Needle like pain occurred 1 to 2 hours before the rash appeared. First appeared on the upper torso, then spread up and down from there. Voice became hoarse and remained that way as long as the rash was present. After taking oral prednisone (2 tablets once daily), topical prednisone (1%) and 2 (25mg) benedryl every 4 hours for 48 hrs rash lightened and disappeared. Raspy voice disappeared as well.
57 2021-04-24 numbness and pain in extremities the intensity of the CIPN increased exponentially; the intensity of the CIPN increased exponentially... Read more
the intensity of the CIPN increased exponentially; the intensity of the CIPN increased exponentially; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) at the age of 57-year-old, via an unspecified route of administration, administered in left arm on 20Mar2021 13:30 as single dose for COVID-19 immunisation. Medical history included metastatic breast CA, known allergies to oak tree and pollen, and residual bilateral CIPN in the balls and toes and feet. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination and has not been tested post vaccination. Concomitant medications included olaparib, durvalumab, and levothyroxine sodium (SYNTHROID). On 22Mar2021 07:30 (also reported as two days after receiving the first dose), the intensity of the CIPN increased exponentially. This lasted about 5 days when it slowly started to return to normal levels at 2.5 weeks after the first dose. No treatment was received for the events. The outcome of the events was recovered on Apr2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported "intensity of the CIPN increased exponentially" cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-04-24 tingling, cold extremities, hot flush intermittent lightheadedness; migrating sensation of tingling over body & face; bowel urgency; warm ... Read more
intermittent lightheadedness; migrating sensation of tingling over body & face; bowel urgency; warm flush; though very fatigued; coldness of feet, then hands; This is a spontaneous report received from a contactable Other-Health Care Professional (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, lot number: EN6201 and Expiry date was not reported), via an unspecified route of administration in left arm on 20Feb2021 as single dose for COVID-19 immunization. The patient medical history included Hypothyroid, Hypertension, Menopause and Shrimp allergy were reported. The patient concomitant medications Synthroid, Telmisartan/HCTZ, Prempro were reported. No other vaccination in four weeks. Patient did not have covid prior vac-cination. On 20Feb2021 Immediate post vaccination onset of intermittent lightheadedness and mi-grating sensation of tingling over body & face; at 45 minutes also experienced a sequence of cold-ness of feet, then hands (w/decreased perfusion), as those resolved then core/trunk, as trunk warmed then at 75 min upper gums, then eyelids, then nose; bowel urgency; at 2 hours warm flush, mind clearer, better color vision, feeling stronger; lightheadedness resolved within 3 hours of pharmacist observation. No urticaria, angioedema or respiratory distress. No treatment. Could stand and walk with assistance, though very fatigued. Rested at home. Re-presentation of light-headedness & tingling on 22Feb & again mildly on 24Feb while resting. Patient did not receive any treatment for adverse event. Patient did not tested covid post vaccination. The outcome for event peripheral coldness was recovered and for events dizziness, paraesthesia, Anal incontinence, Hot flush, Fatigue was recovering. No follow-up attempts are possible; No further information is expected.
57 2021-04-24 seizure possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal p... Read more
possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal pain; temperature spike at 101; unquenchable thirst; sweating; This is a spontaneous report from a contactable consumer (patient) reported for herself that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 08Apr2021 04:00 PM (Lot Number: EW0151) at single dose for covid-19 immunization. Medical history included multiple allergies from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, orthostatic hypotension from an unknown date and unknown if ongoing , traumatic lung injury from an unknown date and unknown if ongoing , metaplasia from an unknown date and unknown if ongoing , hiatus hernia from an unknown date and unknown if ongoing , polyp from an unknown date and unknown if ongoing , diverticulum intestinal from an unknown date and unknown if ongoing , exposure to toxic agent from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; famotidine taken for an unspecified indication, start and stop date were not reported; cyclobenzaprine taken for an unspecified indication, start and stop date were not reported; calcium carbonate;soya isoflavones;vitamin d nos taken for an unspecified indication, start and stop date were not reported; ibuprofen;phenylephrine hydrochloride taken for an unspecified indication, start and stop date were not reported. The patient previously took firs dose of bnt162b2 (BNT162B2) intramuscular, administered in Arm Right on 18Mar2021 04:15 PM(Batch/Lot Number: ER2613) at single dose for covid-19 immunisation. The patient experienced possible seizure on 08Apr2021 20:00 with outcome of recovering , chills on 08Apr2021 with outcome of recovering , headache on 08Apr2021 with outcome of recovering , joint and long bone pain on 08Apr2021 with outcome of recovering , dizziness on 08Apr2021 with outcome of recovering , fainting on 08Apr2021 with outcome of recovering , right abdominal pain on 08Apr2021 with outcome of recovering , temperature spike at 101 on 08Apr2021 with outcome of recovering , unquenchable thirst on 08Apr2021 with outcome of recovering , sweating on 08Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included body temperature: temperature spike at 101 on 08Apr2021. Therapeutic measures were taken as a result of possible seizure. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical course was reported as follows: 4 hrs post vax: chills, sub normal temperature drop >96 f oral, eat, and airmpit , sub normal low BP, headache, joint and long bone pain, dizziness, 2 episodes of warned fainting (vasovagal); followed by temperature spike at 101 F oral onset @21 hrs. post vax riggors and falls, with warned loss of consciousness & possible seizure, followed by lower right abdominal pain w/rebound tenderness, sweating, unquenchable thirst, until fever broke 30 hrs post onset. At febrile onset 400 mg ibuprofen, followed by 200 mg every 8 hrs until symptom resolution. The adverse event result in any of the following Doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event included Public Health RN telephone consult, ibuprofen see. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products:Yes a long list that does not include PG. Other diagnosed illnesses/medical history/chronic health conditions:IMMUNE SYSTEM: multiple allergies including anaphylaxis; R.A., reactive asthma; CARDIOPULMONARY: reactive asthma, chemical exposure lung injury scaring, COPD, orthostatic hypotension; GI: Barrets esophagial metaplasia, hiatal hernia, colonic polyps adenocarcinoma, diverticula. Follow-up (20APR2021): Follow-up attempts completed. No further information expected.
57 2021-04-24 tremor, pain in extremity I became extremely tired and my legs were so sore. I had a very hard time getting out of bed, puttin... Read more
I became extremely tired and my legs were so sore. I had a very hard time getting out of bed, putting my shoes and socks on and bending over. It is so painful that i shake when I bend over. I have also had a headache on and off since then. I called the CDC, Health Dept, amd my doctor and was told that was normal. When I went for my secoond shot the nurse who administered the shot said it was my lymph nodes. I went to my doctor who ordered some bloodwork. My SED Rate West was 38, CRP Extended range was 59.62 and my RBC was 4.15. These are not typos! These were completed on March 11, 2021.
57 2021-04-25 weakness, feeling hot I started to experience pain in my right ear. Soon I felt pressure in my ear and sinuses. I felt l... Read more
I started to experience pain in my right ear. Soon I felt pressure in my ear and sinuses. I felt like I needed to unplug my ears but swallowing didn?t help. Additionally, my ears felt warm. At the same time the tinnitus in my right ear, which had been mild for years, became much more pronounced. It was debilitating and I had trouble sleeping. After the second shot, the symptoms continued except I started to feel them in my left ear as well. Now I also have tinnitus in the left ear, although it isn?t as loud as my right.
57 2021-04-25 weakness Symptoms of rash growing in size at my left ear, quickly spreading and thickening with yellow liquid... Read more
Symptoms of rash growing in size at my left ear, quickly spreading and thickening with yellow liquid oozing, crusting over, breaking and oozing. Spreading down my neck to my collar bone area and taking over my whole ear front and back. Spreading further to my jawline and upward and behind the eat into the hairline as I was misdiagnosed and on three different antibiotics and a probiotic for two weeks prior to being sent to the ER for a IV of heavier antibiotics. The ER doctor declined the IV and immediately identified shingles, prescribing Valacyclovir which cleared it over another week and a half. The cost after insurance for just the ER visit was 860.00, plus an office visit for 65.00 together, and the RX prescribed. I was also in bed without energy, missing work due to the illness affect for a week.
57 2021-04-25 weakness Weakness, achiness, chills
57 2021-04-25 breast pain Extreme pain in left breast
57 2021-04-25 burning sensation The reaction started with a stuffy nose, then runny nose, then went back and forth. That was follow... Read more
The reaction started with a stuffy nose, then runny nose, then went back and forth. That was followed by a red-spotted rash that began on legs and arms. The rash is extremely itchy and in certain areas the spots all ran together into giant red patches which burn and hurt like a severe sunburn. At the same time the spots were showing up, a small lump formed behind the left ear and was painful. The pain ran up higher on the head on the same side and down the neck on the same side. Over the counter pain meds, benadryl, pepcid, and clariton were tried with no results. An urgent care visit resulted in a steriod pack prescription.
57 2021-04-25 pain in extremity SHINGLES, LASTED ABOUT A WEEK. SORE LEFT ARM WITH LIMITED MOVEMENT AND STILL SORE 4 SEEKS AFTER 1ST ... Read more
SHINGLES, LASTED ABOUT A WEEK. SORE LEFT ARM WITH LIMITED MOVEMENT AND STILL SORE 4 SEEKS AFTER 1ST SHOT.
57 2021-04-25 pain in extremity 3/4-first vaccine in left arm, only effect was sore arm when I laid on it. 3/25-second vaccine in ri... Read more
3/4-first vaccine in left arm, only effect was sore arm when I laid on it. 3/25-second vaccine in right arm, arm hurt to lift as well as lay on. Start approx 1515 hrs, severe headache anvil like pressure at back of head 3/26-body aches, some dizziness 3/26-3/28 temperature from 99-102+ with chill, aches, etc 3/28-4/1 extreme fatigue, brain fog. 4/1 to present: random fatigue, headaches, nose bleeds but 4/22 the fatigue brain fog became extreme again. 4/25 spend most of the day in bed sleeping or just laying there with no motivation or ability to get up and focus on a task 4/26: went to work, but again, extreme fatigue, just want to lay down, no focus
57 2021-04-25 tingling, flushing Shortly after her shot she experienced a flushed feeling and some L arm tingling. She also felt li... Read more
Shortly after her shot she experienced a flushed feeling and some L arm tingling. She also felt lightheaded and dizzy. She had no new rashes or hives. She recently returned from 1 week in Florida and had some sun burn on her forehead and arms, that was unchanged by her own mirror inspection and husband's evaluation. She had no SOB or wheezing on multiple exams. No throat tightness, tongue swelling, or palate tingling. Symptoms resolved slowly over a 1 hour observation period. BP, pulse, and O2 sats were all stable through her stay. Initial BP = 148/63, Pulse = 78%, 100% sat. No orthostasis at discharge. No adverse Rxn to 1st Covid shot. She has a Hx of bee sting allergy and carries an Epi pen usually. She did not have it with her today. My impression was a mild focal allergic reaction without progression. Advised patient & husband to go to ED if symptoms return.
57 2021-04-25 tingling Tingling in lips and left side of face. Started immediately after injection and lasted for 30 minut... Read more
Tingling in lips and left side of face. Started immediately after injection and lasted for 30 minutes.
57 2021-04-25 speech disorder, weakness Pfizer-BioNTech Covid-19 Vaccine EUA Swelling in throat, difficulty breathing, difficulty speaking, ... Read more
Pfizer-BioNTech Covid-19 Vaccine EUA Swelling in throat, difficulty breathing, difficulty speaking, very high blood pressure, dizzy, weakness, all symptoms began within 2 minutes of receiving shot, medical attention immediately on site, transported me to hospital as systems became worse shot me up with benedryl which over a few hours I was able to leave hospital, the systems subsided a bit but persisted with feeling like throat full of cotton for additional 4 days, still not feeling as did prior to shot- still having bouts of shortness of breath but getting better every day. still feel week, slugish, short on breath
57 2021-04-26 feeling cold, tingling Face red around nose and mouth; I'm cold; Feel like lots of pins pricking me; This is a spontaneous ... Read more
Face red around nose and mouth; I'm cold; Feel like lots of pins pricking me; This is a spontaneous report received from contactable consumer (patient). This 57-year-old non-pregnant female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 26Mar2021 at 11:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included melatonin, cetirizine hydrochloride (ZYRTEC), and naproxen sodium (ALEVE), all from unknown dates for unknown indications. The patient reported that 48 hours after the shot, she experienced face red around nose and mouth. She took diphenhydramine hydrochloride (BENADRYL) and was feeling better, although she reported she was cold and felt like lots of pins were pricking her. It was reported that no treatment was received for the events. The clinical outcome of face red around nose and mouth was recovering; the outcomes of I'm cold and feel like lots of pins pricking me were unknown. It was also reported that since vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
57 2021-04-26 numbness On April 1st lost all eye sight in right eye for a few minutes and wet feeling in right quad all da... Read more
On April 1st lost all eye sight in right eye for a few minutes and wet feeling in right quad all day (thought my leg was wet all day but wasn't). On April 2 woke up to stabbing pains in eye and couldn't see in right eye. Went to (Regular doc) that afternoon (Vision in left eye 20/25, right eye 20/70)she referred me to Opthamologist right then. Opthamologist diagnosed me with Optic Neuritis in right eye (50% loss of brightness and color). Referred to Neurologist, hands and legs going numb, bad vertigo. Neurologist ordered 3 MRIs with and without contrast (Brain, Thoracic spine and cervical spine). All clear. Numbness, vertigo continues. On April 18th woke up with swollen/red cheeks and fluid build up under both eyes.. same place a where filler was injected into face. On April 19, did a wide range of blood work...all normal except CRP was 25.1. Gave me penicillian and steroid shot, and 7 day steroid pack. Vertigo and numbness continued. On April 27th symptoms seem to be a better but everyday this moves around my body with different symptoms like one day my left hand is numb and the next it's my right hand. Eyesight still not normal. Vision in right eye is blurry, compared to left.
57 2021-04-26 pain in extremity Extremely heavy menstruation over one week after second injection on March 31, 2021. Very unusual si... Read more
Extremely heavy menstruation over one week after second injection on March 31, 2021. Very unusual since I now only have a light cycle 3 times a year. First shot was March 10th, experienced only arm soreness.
57 2021-04-26 tremor, feeling cold C/O chills and body shaking. Was very cold. Paramedics assessed and released about an hour later.
57 2021-04-27 burning sensation Herpes zoster without complication, rash, itchy/burning/painful. Treated with Benadryl, hydrocortiso... Read more
Herpes zoster without complication, rash, itchy/burning/painful. Treated with Benadryl, hydrocortisone cream, Valacyclovir 1 g 3 times daily for 7 days, dermatology consult to confirm (confirmed)
57 2021-04-27 facial pain 4/24/21 1:05pm first dose Pfizer vaccine 1:10pm huge allergic reaction, felt like pre-anaphylaxis,... Read more
4/24/21 1:05pm first dose Pfizer vaccine 1:10pm huge allergic reaction, felt like pre-anaphylaxis, like I was going to die 1:13pm took 2 Benadryl 25mg 5:30pm took 1 Benadryl 25 mg Loose stools all day, stayed home as Benadryl was working 4/25/21 12:30am took 1 Benadryl 25mg (weird feeling in my tongue) 1:25pm took 1 Benadryl 25mg for pain in my cheekbones & teeth and rash on both cheeks below eyes 1:58pm took 1 Benadryl 25mg " " 2:19pm took 1 Benadryl 25mg " " 2:49pm checked into hospital emergency room as allergic reaction would not subside 4:30pm got IV with Benadryl 25mg, Methylprednisolone & Pepcid (throat felt strange) 7:26pm discharged from ER 4/26/21 Medrol 24g 4/27 Medrol 20g
57 2021-04-27 feeling hot Pt. feels hot, dizzy, not feeling well, headache 7/10. 134/74. 99%, 80, BG 95. Pt. Stated that she'... Read more
Pt. feels hot, dizzy, not feeling well, headache 7/10. 134/74. 99%, 80, BG 95. Pt. Stated that she's still feeling unwell but want to go home. Pt. A+Ox3. Pt. verbalized that she will go eat. Pt. advised to call EMS if symptoms persist. Pt. advised to f/u with primary doctor. Pt. verbalized understanding.
57 2021-04-27 tingling Pt developed dizziness and tingling shortly after vaccination. She notes that she felt very anxious ... Read more
Pt developed dizziness and tingling shortly after vaccination. She notes that she felt very anxious prior to vaccination. No skin, respiratory or ENT symptoms. BP 130/70, HR 66, SPo2 99%. Pt improved over the course of several minutes without intervention. She elected to drive home with a family member.
57 2021-04-28 weakness pain and swelling at injection site, redness~ 4 inches diameter; fever (100 F), chills, body ache, h... Read more
pain and swelling at injection site, redness~ 4 inches diameter; fever (100 F), chills, body ache, headache, palpitations, weakness
57 2021-04-28 weakness Body and muscle pain, joint pain, nausea, headache, taste change, fatigue, body weakness
57 2021-04-28 numbness HA, chills, anxiety, tongue and fingers go numb during anxiety attack 4-24-21ER was told she had a p... Read more
HA, chills, anxiety, tongue and fingers go numb during anxiety attack 4-24-21ER was told she had a panic attack
57 2021-04-28 numbness woke up and my left side of my face was numb with blurred vision
57 2021-04-28 pain in extremity Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe ge... Read more
Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe general back pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 20Jan2021 13:30 (at the age of 57 years old) as single dose for COVID-19 immunisation, at a workplace clinic. Medical history included hypertension (HTN) and depression, both from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. The patient has no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT); and benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ) both taken for an unspecified indication. On 22Jan2021 the patient experienced arm pain and severe general back pain. On 23Jan2021, the patient experienced severe dizziness and vomiting. She went to urgent care and symptoms were treated. The patient was advised to have follow-up with the patient's professional care provider; she had MRI and CT angio of head on an unknown date with unknown results. The patient was diagnosed with cryptogenic posterior cerebellar CVA on 23Jan2021. Due to the events, the patient was recommended to have full diagnostic working including cardiac and neuro workup as treatment. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for three days. The patient underwent lab tests and procedures which included CT angio of head and magnetic resonance imaging (MRI): both with unknown results on an unknown date, and Nasal Swab: negative on 12Apr2021. The patient was recovering from the events.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that vaccine BNT162B2 contributed to the reported events; these are likely intercurrent medical conditions in this patient with underlying hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-04-28 pain in extremity Had been fine for 2 days. All of the sudden I couldn't lift my right leg - pain was from upper thigh... Read more
Had been fine for 2 days. All of the sudden I couldn't lift my right leg - pain was from upper thigh, hip, to mid waist. I was unable to drive, and that evening the pain was excruciating making it difficult to get comfortable to sleep. It has improved with rest, heat, and ice, but I still do not have full motion of my right leg. If it does not improve, I will go see my dr.
57 2021-04-29 feeling hot Face/neck/chest were red. I I felt warm. Took my temperature, twice, and it wasn't even 98.6. I have... Read more
Face/neck/chest were red. I I felt warm. Took my temperature, twice, and it wasn't even 98.6. I have had, in the past, very fine rashes, that, before, were usually contact dermatitis. It eventually resolved on it's own.
57 2021-04-29 feeling hot I had my first dose of the Pfizer COVID-19 vaccine on Tuesday, April 27, 2021. On Wednesday morning... Read more
I had my first dose of the Pfizer COVID-19 vaccine on Tuesday, April 27, 2021. On Wednesday morning, April 28th, I noticed that my knees we swollen. As the day progressed, I became tired and vacillated between being chilled and hot. I did not have any other symptoms. On Thursday, April 29th, I noticed that my clothes were fitting very snug. It appears that the COVID-19 vaccine has caused my body to become swollen. To test this theory, I put on a pair of pants that I wore on Monday, April 26, 2021, which were baggy. And the same pants are tight. I am scheduled for my second dose of the COVID-19 vaccine on May 18, 2021.
57 2021-04-29 numbness, pain in extremity Started with diarrhea, nausea, severe fatigue & headache on 4/26/21. On 4/27 & 4/28/21, severe pain... Read more
Started with diarrhea, nausea, severe fatigue & headache on 4/26/21. On 4/27 & 4/28/21, severe pain in back and radiating down legs. Increased numbness in hands & legs, legs heavy and hard to walk, severe headache. Pain unrelenting despite percocet , tylenol & compazine. I had stopped my SQ immune globulin (SCIG) infusions a week prior and a week after the vaccine - as recommended by my neurologist. I was in this second week when these symptoms exacerbated. It was very similar to a CIDP relapse.
57 2021-04-29 pain in extremity My left arm hurt very bad. Within three days , my shoulder was in too much pain to use. It worsened ... Read more
My left arm hurt very bad. Within three days , my shoulder was in too much pain to use. It worsened and ached and throbbed with Extreme pain even when not moving it. I could not sleep or use the arm at all. The whole shoulder and arm. It was constant agony red.
57 2021-04-29 pain in extremity Site: Pain at Injection Site-Medium, Additional Details: patients arm still hurts. it might have bee... Read more
Site: Pain at Injection Site-Medium, Additional Details: patients arm still hurts. it might have been given up too high causing bursitis.
57 2021-04-30 weakness, pain in extremity April-28-2021 around 9:21am woken up to nauseous headache right side joint pain left arm neck should... Read more
April-28-2021 around 9:21am woken up to nauseous headache right side joint pain left arm neck shoulder dizziness weakness heart was beating fast. Been very tired.
57 2021-04-30 weakness feeling unwell; Just stayed in bed and rode it out.; slight rash at injection sight/red rash; inject... Read more
feeling unwell; Just stayed in bed and rode it out.; slight rash at injection sight/red rash; injection site itchy; armpit swollen/armpit swollen; 103 fever; sweats; severe pounding headache; no energy; tired; chills; wiped out/weak; nausea; diarrhea; no appetite; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8729) dose 2 via an unspecified route of administration, administered in right arm on 07Apr2021 11:00 as SINGLE DOSE for covid-19 immunization. Medical history included Blood pressure, Diabetic, potassium and some known allergies of Sulfa, Bees. Historical vaccine was covid 19. The patient's concomitant medications were not reported. On 08Apr2021 at 12:00 AM, the patient experienced chills, sweats, up to 103 fever, severe pounding headache, no energy, tired/wiped out/weak, nausea, diarrhea, no appetite, red rash at injection site, itchy, armpit swollen, started about about 12 hours after shot. The patient stated that first 3 days was roughest. Everything above lasted for 4 days. Day 5 just little energy, feeling unwell and slight rash at injection sight/sight swelling armpit and no appetite. Just stayed in bed and rode it out. The outcome of the events was reported as recovering. The action taken in response to the events for bnt162b2 was not applicable.
57 2021-04-30 weakness Sharp pain and aching over entire body, weakness, all joints in pain, headache, swollen lymph node b... Read more
Sharp pain and aching over entire body, weakness, all joints in pain, headache, swollen lymph node by left jaw
57 2021-04-30 breast pain, pain in extremity pain in her left armpit gradually got worse and moved to her hand and all of her left arm; pain in h... Read more
pain in her left armpit gradually got worse and moved to her hand and all of her left arm; pain in her left armpit gradually got worse and moved to her hand and all of her left arm; pain on the side and above her left breast; her cholesterol is good except her triglycerides; she had a feeling of indigestion; she woke up with upper left back behind shoulder blade pain; more pain and swelling and redness at the injection site; more pain and swelling and redness at the injection site; more pain and swelling and redness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 15:00 (Batch/Lot Number: EW0151) as SINGLE DOSE for covid-19 immunisation, at 57 years old on a mass vaccination site. Medical history included ongoing chronic bronchitis, diabetic (blood sugar is under good control), Chronic Obstructive Pulmonary Disease, ongoing gastrooesophageal reflux disease (GERD), Gastroparesis, ongoing essential hypertension, benign, ongoing Mixed hyperlipidemia, ongoing hypoxia, ongoing obstructive sleep apnea, ongoing Lymphedema, ongoing Osteoarthritis, ongoing Vitamin D deficiency, she is a smoker (she's trying to quit with patches), pain, normally high platelets and been on pain medicine several years due to low back pain; all from unspecified dates. She received SHINGRIX vaccine on 25Jun2019 and reported the first shot of her Shingrix vaccine was really painful. She received the first dose of BNT162B2 (Lot number: ER8727) on 18Mar2021 10:30 in the left arm and she had minimal injection site pain that resolved, age at vaccination was 57 years old. Concomitant medication included hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN) taken for pain from an unspecified start date and ongoing; guaifenesin taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid, caffeine (BAYER BACK & BODY PAIN) taken for pain, start and stop date were not reported. The patient previously took baby aspirin from an unspecified date and experienced bothering her stomach. No other vaccinations within 4 weeks.The patient woke up with upper left back behind shoulder blade pain on 11Apr2021 which got worse as the day went on. She normally coughs every day because she has chronic bronchitis and it has been very painful to cough. Around 4 PM, pain in her left armpit gradually got worse and moved to her hand and all of her left arm on 12Apr2021. She also had pain on the side and above her left breast on 12Apr2021. The pain was so severe she went to the ER the night before because she was concerned, she might have been having a heart attack. The ER checked her out and found nothing and she followed up with her primary care doctor and has not gotten a response yet. There was more pain and swelling and redness at the injection site (on 08Apr2021) and it took a little bit longer to resolve but it has resolved. On 11Apr2021, she woke up with a terrible pain in her back under her left shoulder blade and as the day went on it, the pain got worse as the day went on, so she used a heating pad and a handheld vibrating pad for about an hour. She developed a bad pain that came on gradual in her left armpit. She went to bed with the heating pad on her back and yesterday, 12Apr2021, the pain was worse. When she coughed there was extreme pain. She normally coughs up phlegm every day because she has chronic bronchitis and it has been very painful to cough. After a while she could feel the pain in her left hand coming up her left arm. Essentially her whole left arm, left breast and above her left breast. She called the urgent care and called her primary care doctor's after-hours service and spoke to the doctor. She was worried about a heart attack or side effect of the vaccine and the doctor on call advised her to go to urgent care or emergency department for an EKG. She went to the emergency department around 8:30 PM. It took her an hour to get in a room. The emergency department did an EKG, they took blood and inserted an IV, but they didn't give her medication in the IV. She got a nitro paste patch on her left chest. She also got 3 baby aspirin to chew (a preventative for her heart. Aspirin 81mg Equate brand, low dose chewable), and a chest X-ray. The emergency room didn't see anything. Everything looked good or normal. The emergency room was looking for an elevated troponin which would indicate heart trouble and her troponins were not elevated. While the emergency department nurse was going over this information with her, she had a feeling of indigestion on 12Apr2021, so she was given a GI cocktail. The nurse told her it would numb her mouth and not to eat or drink for 30 minutes. It was a thick liquid. It was to coat her stomach. She doesn't know what was in the medication. Her symptoms are possibly related to the COVID 19 vaccine in her mind because she received her second vaccine on Thursday 08apr2021 and started having these pains on Sunday, 11Apr2021. She doesn't know what else to do. The pain could be from several things and she's concerned. She reports her white blood cell counts are normal for her. Her platelets are slightly high, but they are normally high for her. Her A1C is in range at 4.6%. Her thyroid is normal, her vitamin D is good, and her cholesterol is good except her triglycerides (12Apr2021). Her pain medicine is not touching this pain that she's having. The patient underwent lab tests and procedures which included blood cholesterol: good except her triglycerides, blood test: unknown results, chest X-ray: unknown results, electrocardiogram: unknown results, glycosylated haemoglobin: 4.6 %, platelet count: slightly high, troponin: were not elevated, white blood cell count: normal on 12Apr2021. Therapeutic measures were taken as a result of she woke up with upper left back behind shoulder blade pain; pain in her left armpit gradually got worse and moved to her hand and all of her left arm (pain in extremity and axillary pain); pain on the side and above her left breast; and she had a feeling of indigestion. Events required emergency room visit. Outcome of the events upper left back behind shoulder blade pain, pain in her left armpit/moved to her hand and all of her left arm was not recovered. Outcome of the events more pain and swelling and redness at the injection site was recovered on an unspecified date. Outcome of the other events was unknown.
57 2021-04-30 hot flush Low blood pressure (87/46mmHg); hot flashes little by little; Headache; Arm was also sore; Fever; Th... Read more
Low blood pressure (87/46mmHg); hot flashes little by little; Headache; Arm was also sore; Fever; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 12Apr2021 10:30 am (Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included anxiety attack. The patient's concomitant medications were not reported. The same day that she received the Covid 19 vaccine on 12Apr2021, she had a little bit of fever but the next day the fever was gone. On the 13Apr2021 she had a headache, she took some Tylenol and the headache went away that same day. Her arm was also sore on the first and second day. Patient reported she did have a headache but she thought it was related to the weather because the weather affected her sometimes. She did not think her headache today was related to the vaccine. On 13Apr2021, she started getting hot flashes little by little. She is doing fine now. She has had hot flashes for the last 2 days. She also had low blood pressure. She reported she had taken her blood pressure and gotten the following results. 94/60mmHg, 99/63mmHg, 87/46mmHg. This morning (unspecified) her blood pressure was 99/63mmHg and now it's 107/65mmHg. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No emergency room and physician office required. No prior vaccinations within 4 weeks. The event outcome for low blood pressure (87/46mmHg) was recovered on unspecified date, for hot flashes little by little was recovered on 15Apr2021, for fever and headache was recovered on 13Apr2021, for arm was also sore was unknown.; Sender's Comments: A contributory role of BNT162B2 to the event headache cannot be excluded based on a compatible temporal relation and known safety profile of suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
57 2021-04-30 muscle spasms Chest tightening (Major), Left shoulder muscular spasms that moved up to MAJOR muscle spasms on left... Read more
Chest tightening (Major), Left shoulder muscular spasms that moved up to MAJOR muscle spasms on left side of neck, moved to upper back, and over to right muscle in neck (major), fog Also had MAJOR Head ringing, light headed vertigo (I can't even describe) I felt like everyone was yelling and my head was in a fog.
57 2021-04-30 pain in extremity, tenderness Vein protruding, extreme arm pain and swelling, high fever, sensitivity to touch
57 2021-04-30 pain in extremity left thumb pain, sore, warm, pain. about a week after the shot. My sister which got shot at a comple... Read more
left thumb pain, sore, warm, pain. about a week after the shot. My sister which got shot at a completely different location and day has the same issue but more severe .
57 2021-04-30 pain in extremity sore arm; This is a spontaneous report from a contactable consumer, reporting for herself. A 57-year... Read more
sore arm; This is a spontaneous report from a contactable consumer, reporting for herself. A 57-year-old female non-pregnant patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EN6206), via an unspecified route of administration on 08Mar2021 at 16:00 in the left arm at a single dose for covid-19 immunisation. The patient received the vaccinations in a health clinic/administration facility. The medical history was not reported. There were no allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]); biotin (BIOTIN). No other vaccinations administered within 4 weeks prior to bnt162b2 vaccination. On 31Mar2021, the patient experienced sore arm for 1 day, which were non-serious. There was no treatment given in response to the event. There was no covid prior to or post bnt162b2 vaccination. The clinical outcome of the event not recovered. No follow-up attempts are required. No further information is expected.
57 2021-04-30 tingling, discomfort 24 hours later after the second vaccine I began to feel tightness in my chest and my throat that fel... Read more
24 hours later after the second vaccine I began to feel tightness in my chest and my throat that felt similar to GERD. Simultaneously I got the chills and had tingling in my head with a slight headache. I had to go to bed because I didn't know what to do so I took a atarax and protonix. 707 p.m. same day felt a little better in terms of the throat tightening but still feeling the same sensations very uncomfortable.
57 2021-04-30 tingling At first, I experienced fever, chills, body aches, headache. Then experienced tingling in feet and ... Read more
At first, I experienced fever, chills, body aches, headache. Then experienced tingling in feet and hands, and now also in left cheek.
57 2021-05-01 burning sensation, numbness, pain in extremity My lips are numb. My left side is swollen and numb. There's a little soreness in my left arm, but... Read more
My lips are numb. My left side is swollen and numb. There's a little soreness in my left arm, but very sore in my left armpit (lymnodes) My skin feels itching today. I felt a burning sensation and numbness last night.
57 2021-05-01 muscle twitching, speech disorder Headache, cold, eye lid got big with pain and not closing properly, pain in back of left ear with ri... Read more
Headache, cold, eye lid got big with pain and not closing properly, pain in back of left ear with riggings, left face switch to right side, unable to hear properly, unable to talk properly on 3/4/2021 but left face switch still persiste on 5/2/2021 Treatment with Valacyclovir and prednisone
57 2021-05-01 pain in extremity Same day: headache and dry mouth, sore injection site 2nd day: headache worsened, dry mouth worsen... Read more
Same day: headache and dry mouth, sore injection site 2nd day: headache worsened, dry mouth worsened, site was hot to touch, red and swollen; could not sleep that night due to headache, pressure on chest and sore arm; fever began 3rd day: Fever measured at 102 in morning, skin all over very painful to touch, chest pain faded while other symptoms began - fatigue, nausea, continued headache and extremely faint (light-headed every time I attempted to stand or walk), arm redness and swelling still 4th day: Fever measured 101.4 in morning, continued symptoms as day 3, but nausea improved, new added musle (thigh aches) and joints in fingers. Inje 5th day: Fever measured 100.5 in morning, nausea gone, skin pain gone
57 2021-05-01 pain in extremity A couple days after second dose my arm has a red area that's spreading and pain and feels warm to th... Read more
A couple days after second dose my arm has a red area that's spreading and pain and feels warm to the touch
57 2021-05-01 tremor Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tig... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Severe, Systemic: Tinnitus-Mild
57 2021-05-01 tremor Severe Shaking chills, severe myalgias and arthralgias; restlessness; joint stiffness; pain all over... Read more
Severe Shaking chills, severe myalgias and arthralgias; restlessness; joint stiffness; pain all over; mild nausea and orthostatic dizzyness; mild anorexia
57 2021-05-02 bell's palsy Diagnosed with Bells Palsy on 5/1/21, two days after second dose was administered.
57 2021-05-02 burning sensation The day after she noted a burning pain in thighs her down both legs and her back and also involves b... Read more
The day after she noted a burning pain in thighs her down both legs and her back and also involves both her forearms. Any movement, especially walking causes more pain in there legs and back. It is difficult for her to separate whether this is in the muscles or joints. The pain has been getting worse and over the last few days she has noted swelling of her LLE and says that she can't put her shoe on. Despite the swelling on the L, she says the R leg hurts more.
57 2021-05-02 migraine This is a 57-year-old female with history of epilepsy on lacosamide who just received her second do... Read more
This is a 57-year-old female with history of epilepsy on lacosamide who just received her second dose of the Pfizer coronavirus vaccine and she noted onset of double vision, nausea, light sensitivity, headache that is throbbing in nature. This is gradual in onset. She reports these symptoms are similar prior to her seizures. Her last seizure was March when she had coronavirus. She denies any history of migraines. She otherwise denies any chest pain or dyspnea. No urinary or bowel complaints otherwise.
57 2021-05-02 pain in extremity Extremely painful arm starting in the afternoon of the day of the shot; feverish in the afternoon; t... Read more
Extremely painful arm starting in the afternoon of the day of the shot; feverish in the afternoon; took Tylenol; deep mucousy racking cough and fever overnight; less sore arm the next day; sore throat, chills, took Tylenol, chest congestion continues.
57 2021-05-03 inability to speak 2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea w... Read more
2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea was like morning sickness or being punched in the stomach; Stomach ache; She had terrible depression. She said she had a history of depression and took medication for the depression; She was having trouble expressing herself and speaking. She found it very difficult to find words during a conversation; her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose; she was having trouble processing information since her second Pfizer COVID-19 Vaccine shot. She said things get jumbled easily; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female consumer reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 09Mar2021 (at the age of 57-year-old female) as single dose for COVID-19 immunisation. The patient medical history included depression for at least 30 years and breast prosthesis user. She said when she takes her medicine, Fluoxetine, she could not even tell she had depression. She had been on Fluoxetine for a decade. She had breast implants placed from about 31 years ago and wondered if her old breast implants triggered an immune response. She grasped at straws to try and figure out what was going on. On an unspecified date in 2021, with her first Pfizer COVID-19 Vaccine, she only had a little fatigue, clarifying the fatigue was very slight. Concomitant medications were not reported. The patient previously took she her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021. The patient reported that her doctor encouraged her to report adverse side effects that happened after the second Pfizer COVID-19 Vaccine shot. She said that she was okay on 10Mar2021. On 11Mar2021, two days after her second vaccine shot, she had terrible nausea and stomach ache. She clarified the nausea was like morning sickness or being punched in the stomach and that her nausea had nothing to do with her bowels. In Mar2021, she said maybe the next day, she had terrible depression. She clarified of having a history of depression and took medication for it. She said it had been about a month since the nausea and depression started and she felt she had just turned the corner on both of them. Reported she had not been feeling too depressed since 14Apr2021 (last Wednesday). In Mar2021, she started having cognitive issues, struggling with words and following instructions since Dec2020. She was having trouble expressing herself and speaking as well. She found it very difficult to find words during a conversation. She also had trouble processing information and things got jumbled easily. Her cognitive issues worsened. She had been to see so many doctors with her nausea and enquired if other people had complained about terrible nausea and depression after receiving the vaccine. She was advised to be transferred to Pfizer Medical Information for further assistance with her questions. She said she was a teacher and had not gone to school since 08Mar2021 because she was so depressed and sick to her stomach. Report was not related to a study or programme. No further details provided. The outcome of events stomach ache and having trouble expressing herself and speaking was unknown while rest of all events outcome was not recovered. Information about lot/batch number was requested.
57 2021-05-03 burning sensation On May 3rd I broke out in a rash on the inside of both legs under the knee area. The rash is raised... Read more
On May 3rd I broke out in a rash on the inside of both legs under the knee area. The rash is raised from the skin and pink in color. It itches and burns.
57 2021-05-03 tremor, numbness Client received second dose of Pfizer vaccine @ 2:45pm. Client reported feeling chest tightness and... Read more
Client received second dose of Pfizer vaccine @ 2:45pm. Client reported feeling chest tightness and palpations, trembling and then numbness of right arm and hand, shortness of breath @ 3:23 pm. Client states she has been having "palpitations and difficulty breathing when walking distances for 1 week now", has not followed up with primary care because she is working on her med-care. Client also reports feeling nervous and anxious prior to receiving second dose of COVID vaccine today. Vital signs: blood pressure 165/100, pulse 80, respirations 12 @ 3:23pm. Client is able to talk and answer questions, no labored breathing noted. Vital signs @ 3:34 pm; blood pressure 155/95, pulse 80, respirations 12. Client reports that symptoms have lessened but continue. Client denies any medical history, no medication and no allergies. Client reports no symptoms with first dose of COVID vaccine. At 3:45 pm RN makes client aware that will call EMS, client refuses, states "I have been dealing with these symptoms for a week now and do not want to have ambulance check me out, I would like to go home." RN instructs client to dial 911 if symptoms worsen at home. At 3:49pm, client leaves against medical advice, her son is with her. Client able to walk with steady gait.
57 2021-05-04 inability to speak she was spent; She had terrible depression. She said she had a history of depression and took medica... Read more
she was spent; She had terrible depression. She said she had a history of depression and took medication for the depression; 2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea was like morning sickness or being punched in the stomach; Stomach ache; she was having trouble processing information since her second Pfizer COVID-19 Vaccine shot. She said things get jumbled easily; She was having trouble expressing herself and speaking. She found it very difficult to find words during a conversation.; her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose; Event: her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose was reported as worsened.; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 via an unspecified route of administration on 09Mar2021 as SINGLE DOSE (at the age of 57 years-old) for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing for at least 30 years, breast implant placed about 31 years ago and started having cognitive issues, struggling with words, and following instructions since Dec2020. She said when she takes her medicine, fluoxetine, she couldn't even tell she had depression. She said she had been on fluoxetine for a decade fluoxetine. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) and experienced slight fatigue in 2021 and recovered. She said she was OK on 10Mar2021. In Mar2021, the patient was having trouble processing information since her second Pfizer covid-19 vaccine shot. She said things get jumbled easily on Mar2021, 2 days after her second pfizer covid-19 vaccine shot, she had terrible nausea like morning sickness or being punched in the stomach on 11Mar2021, stomach ache on 11Mar2021, terrible depression, having trouble expressing herself and speaking, found it very difficult to find words during a conversation on Mar2021, her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose on Mar2021, event: her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose was reported as worsened on Mar2021. She said she had seen many doctors with her nausea. She said her nausea had nothing to do with her bowels. She said it had been about a month since the nausea and depression started, and she felt she had just turned the corner on both of them. On an unknown date, she was spent. Treatment for depression worsened included depression medication. The clinical outcome of trouble processing information and cognitive issues had gotten worse was not recovered, recovering for nausea, stomach ache and depression and unknown for trouble expressing herself, spent and speaking. Information on the Lot/Batch number has been requested.
57 2021-05-04 flushing Flushing/sweating and dizziness. After pt rested an extra 15 minutes while being hydrated, pt voiced... Read more
Flushing/sweating and dizziness. After pt rested an extra 15 minutes while being hydrated, pt voiced feeling better and no more dizzines. Stable and released.
57 2021-05-04 numbness and pain in extremities Exacerbation of autoimmune disorder. Increase in neuropathy.
57 2021-05-05 weakness Patient received vaccination midday on 4/30, had mild generalized myalgias on 5/1, by evening of 5/2... Read more
Patient received vaccination midday on 4/30, had mild generalized myalgias on 5/1, by evening of 5/2 had generalized weakness of all extremities causing her to be unable to ambulate was found down on the floor. Admitted to the hospital on 5/1 and transferred to our medical center on 5/2 with persistent weakness. Physical exam concerning for possible transverse myelitis versus myositis versus vaccine reaction with 4/5 strength in all 4 extremities
57 2021-05-05 weakness Headache, nausea, tired/no energy, taste is off
57 2021-05-05 tingling Right after face tighting 2.5 weeks of flu like strmptoms,severe stomach pains, horrific diarrhea, ... Read more
Right after face tighting 2.5 weeks of flu like strmptoms,severe stomach pains, horrific diarrhea, vomiting, nausea, headache, could not think clearly. Malise, rheumatoid arthritis severe flare up Been sick again for 9 days started 3/28/2021 Severe kidney pain, nausea, headache, lethargic, right calve feels like it is in a fire. Could not figure out what was going on Diagnosis Shingles 5/5/2021
57 2021-05-05 seizure 16 hours later chills, fever, nausea and extreme tiredness. Lasted for 24 hours. A week and one day... Read more
16 hours later chills, fever, nausea and extreme tiredness. Lasted for 24 hours. A week and one day later had an unexplainable seizure of two to three minutes and afterwards being unconscious for 25 minutes. Cat scan and MRI all normal.
57 2021-05-06 bell's palsy, facial paralysis Bell's Palsy onset 5/3 at 6 pm. Sought treatment 5/4 left side face droop and paralysis. Given acycl... Read more
Bell's Palsy onset 5/3 at 6 pm. Sought treatment 5/4 left side face droop and paralysis. Given acyclovir and prednisone. Currently still taking. No improvement
57 2021-05-06 pain in extremity, feeling cold arms and back hurt along with feeling tired and cold low grade fever, headache, body aches, diarrhea... Read more
arms and back hurt along with feeling tired and cold low grade fever, headache, body aches, diarrhea, fatigue and a coughing, which is minimal and sometimes productive doxycycline Augmentin
57 2021-05-06 pain in extremity 8 days after both injections excruciatingly painful back of arm, side of arm, and shoulder pain. ... Read more
8 days after both injections excruciatingly painful back of arm, side of arm, and shoulder pain. I have head aches now periodically as well which I never had before these injections. Returned to the doctor after the second shot 4/26/2021 and was giving a prednisone prescription for 3 days of 20 mg and was told to take the Norco I am given for spine pain management for three days. I took all the meds and the pain subsided for 3 days. I call the doctors office back and asked if he wanted to send the prescription again because the pain persist. I was told that he has done all that he can do and I would be referred to an orthopedic doctor on Monday May 3rd, 2021. Its May 6th and I am in screaming pain and still no appointment.
57 2021-05-06 tingling anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150... Read more
anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat is starting to close up; trouble swallowing; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 at 14:45 (Batch/Lot Number: EW0162), at the age of 57 year, as single dose for COVID-19 immunization. Medical history included anaphylactic reaction to spider bites, pruritus, ongoing hypersensitivity, ongoing allergy to arthropod sting. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Lortab [hydrocodone bitartrate;paracetamol] and experienced drug hypersensitivity, singulair and experienced drug hypersensitivity. Concomitant medication included neocell super collagen, 6g collagen six per day as supplement. On 17Apr2021 the patient experienced anaphylactic shock, reported as medically significant. The patient reported "I started to pass out. She had tingle in her lip/her tongue was tingling. Her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat was starting to close up, she had trouble swallowing. She went to the hospital straight from the clinic where she received the vaccine. The patient reported the following: she went for shot at 14:30 and they didn't take her in until like 14:45. Patient stated after the shot, she sat down and knew she had to wait for at least 30 minutes because 10 years ago she had a couple events of anaphylactic shock due to spider bites. So patient stated she knew she should wait. Patient stated she started reading her book and had trouble swallowing at 5 minutes later, but she decided to keep reading book. Patient stated that 10 minutes she started to feel a tingle in her lip and then she started paying attention. Patient stated she then went over to the staff and found someone who was not busy and explained to them what was happening. Patient stated that staff member walked her over to the nurses station and at that time her tongue was tingling and this is not even 15 minutes later. The patient stated they gave her 10 ml of Benadryl and at about 15:05 at about 15:20 they had to give her the epinephrine because her throat was starting to close up and they called 911. The patient stated unfortunately the epi didn't; it may have slowed it down but she started to pass out. She don't know what her oxygen level was at that point. The patient recalled that her BP was 150 something over 90, she thinks she heard 159 before they gave her the Benadryl or at the same time. The patient stated once the EMT's showed up they gave her an IV and gave her steroids and that stopped her throat from closing and they gave her oxygen and that made her feel so much better. The patient stated it's like reliving the story here and her throat is starting to close up, patient clarified she is just choking up thinking about it and denied that her throat is actually closing up during call. The patient stated they did a lot of testing after did not show any signs of clotting which was good. Patient stated she did have trouble breathing, and they checked heart and her heart was fine. Patient states her throat, that is the part she needs to talk with her doctor about. Her throat didn't start to completely relax. Patient stated it was still tight on Sunday and Monday and that was a little concerning for her, but as far as lab work, no. Patient stated she was not admitted to the hospital, she spent 5 hours in the emergency room (ER) for observation and got sent home with an epi pen which she is not going to get and steroids which she finished yesterday. Patient stated she is not going to get the EpiPen because she does not foresee any need for it due to the amount of money it costs. Patient stated it costs $232 dollars and that is just too much, not to mention the amount of money she will have to give to hospital for the bill due to this event. Patient stated she is pretty clear that she won't or shouldn't get the next shot. The clinical outcome of Anaphylactic shock was recovered on 20Apr2021. The clinical outcome of her throat is starting to close up was not recovered. The clinical outcome of the remaining events was unknown.
57 2021-05-07 weakness Getting severe vertigo; diagnosed with vertigo; started to feel very ill/Just doesn't feel too good;... Read more
Getting severe vertigo; diagnosed with vertigo; started to feel very ill/Just doesn't feel too good; Had stroke like symptoms, but didn't have a stroke, had vertigo; Having a little bit of nausea and a little bit of weakness; Having a little bit of nausea and a little bit of weakness; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 10:45 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) as a single dose (at the age of 57 years) for covid-19 immunization. The patient's medical history included diabetic, high blood pressure (diagnosed with this 5 years or more ago, caller was not sure). The patient's concomitant medications were not reported. The patient was previously given flu shot (tries to stay up on taking flu shot. Tries to stay up on them as much as caller can, tries to get every year as long as didn't catch flu, as long as not some reason not to receive the shot), pneumonia shot in 2019 and arm was sore. The patient experienced getting severe vertigo; diagnosed with vertigo, started to feel very ill, and had stroke like symptoms, but didn't have a stroke on 01Apr2021. It was further reported that patient got severe vertigo and it was like if she took her shot it was like 30 minutes after the shot. Patient was still having vertigo side effects. She went to the hospital, was in hospital from 02Apr2021 to 03Apr202 1and they diagnosed her with vertigo and they done tests and all her tests came back normal. Patient was trying to find out if she should I take the second Pfizer shot. It was also reported that later on that day patient called paramedics and was hospitalized for two days. Patient had stroke like symptoms, but didn't have a stroke, had vertigo. Patient had stroke like symptoms, but didn't have a stroke, had vertigo. Wasn't sure if first dose Pfizer Covid Vaccine had anything to do with it, but could have dislodged something in caller's ear that led the vertigo on. Had to go see another specialist, eye ear, throat doctor and test came back fine with this doctor. The patient told the specialist she didn't feel comfortable just going to site where caller received first dose Pfizer Covid Vaccine, patient was more comfortable with hospital setting. The specialist told caller she probably needed to talk to someone that had something to do with the Pfizer Covid Vaccine. Caller was waiting on a call back from her Primary Care Doctor. Patient was supposed to have second dose Pfizer Covid Vaccine on 29Apr2021, next week, patient canceled the appointment due to trying to find out more information. iIt was mentioned that the patient was 75% back to the way usually feels. Having a little bit of nausea and a little bit of weakness. Patient does not have spinning of the room, dizzy and all of that like it was. Just doesn't feel too good. On an unknown date, the patient was having a little bit of nausea and a little bit of weakness. The patient was hospitalized for getting severe vertigo; diagnosed with vertigo, started to feel very ill and had stroke like symptoms, but didn't have a stroke, had vertigo from 02Apr2021 to 03Apr2021. The outcome of the events severe vertigo; diagnosed with vertigo, started to feel very ill, and had stroke like symptoms, but didn't have a stroke was recovering and unknown outcome for the remaining events.
57 2021-05-07 pain in extremity I had a sore arm the first two days which is normal. But on day 4, I started with a very bad sore t... Read more
I had a sore arm the first two days which is normal. But on day 4, I started with a very bad sore throat and then had difficulty breathing. and couldn't stop coughing. When I was a child I used to get asthma, it has been 30 years since I have had asthma. I went to urgent care and they tested for strep throat and Covid 19. I tested negative for both. A week later I called urgent care because I could not stop coughing and was having difficulty breathing. They prescribed a very low dose of Prednisone for 6 days. That did not help so I finally went to my asthma and allergy doctor. He prescribed the correct dose of Prednisone which I am now on day 3 taking. As well as an Inhaler which helps as well and a gel tablet to help with cough. I feel like I am finally on the rode to recovery but I am nervous about taking a 2nd Pfizer Vaccine. My doctor also told me I should not take the 2nd Vaccine until 10 days after I am finished with Prednisone. That will be passed the 42 day recommended time frame to get the 2nd Vaccine. I don't know if the vaccine caused these breathing problems but I do know that I was 100% healthy and hadn't had breathing difficulty for 30 years. That is why I think it may be possible that the vaccine triggered this. I felt it important to report.
57 2021-05-07 tremor Please note, April 27th was my second first dose. My first dose on April 7th at the Wellness Clini... Read more
Please note, April 27th was my second first dose. My first dose on April 7th at the Wellness Clinic is considered invalid by CDC. 1) Severe headache that was not relieved with Tylenol. After waiting about four hours with worsening headache, Advil provided some relief. The severe headache persisted until my mild fever broke about 2AM. Becoming a mild headache into the following week, which is mostly gone by May 7th. 2) Sever chills with shaking. 3) Blue arms to the elbows. 4) Minor fever of 1-2 F above my normal.
57 2021-05-08 muscle spasms I am post-menopausal and have not had a regular menstrual period for 10+ years, however, I have been... Read more
I am post-menopausal and have not had a regular menstrual period for 10+ years, however, I have been experiencing breakthrough bleeding and slight cramping since receiving my second shot.
57 2021-05-08 pain in extremity Nausea, headache, diarrhea, and arm soreness.
57 2021-05-09 weakness Swelling of site arm, increased heart rate, dizziness and weakness, hospitalization
57 2021-05-09 discomfort I received my 2nd Pfizer COVID 19 vaccine on May 4th. 6 hours after the shot, I had severe pain in ... Read more
I received my 2nd Pfizer COVID 19 vaccine on May 4th. 6 hours after the shot, I had severe pain in my lower back, left side with some queasiness when not lying down. Tuesday night and Wednesday were the worst. Tylenol helped alleviate the pain quite a bit, but I was only comfortable when laying on my left side. This lasted off and on thru Thursday, May 6th. I missed work Wednesday and returned to work on Thursday; although I still had some discomfort on Thursday. Then when I awakened Friday morning, it was gone and no pain since then. The pain was not like your typical muscle ache. It was similar in pain to a kidney stone (which I had several years ago and am familiar with that pain).
57 2021-05-09 nerve pain Around 13 hours after vaccination I woke up to muscular and nerve pain all over my body. It didn't s... Read more
Around 13 hours after vaccination I woke up to muscular and nerve pain all over my body. It didn't subside until the following morning.
57 2021-05-09 tingling, pain in extremity, weakness Tingling headache sensation in afternoon on left scalp. Arm pain which traveled to neck and upper ba... Read more
Tingling headache sensation in afternoon on left scalp. Arm pain which traveled to neck and upper back spine. Next am severe stiffness and moderate pain with movement and weakness in arm. Day 2 sweaty, tired and feeling like getting sick. Slight nausea. Day 3 more energy but army neck and upper back pain and stiffness continued with upper arm weakness. Day 4 less pain and stiffness. Day 5 pains and stiffness better.
57 2021-05-10 difficulty speaking Patient received Pfizer COVID-19 vaccines on 4/1/2021, and on 4/22/2021. 57YO female presents on 4... Read more
Patient received Pfizer COVID-19 vaccines on 4/1/2021, and on 4/22/2021. 57YO female presents on 4/30 with chief complaint of chest tightness and throat swelling sensation. Patient has a history of allergic reactions. She developed a mild reaction after her first Covid vaccine (4/1). More severe reaction after her second vaccine which was one week prior (4/22). She was doing better after an ER visit and 2 days of prednisone. On 4/30 she began developing the same symptoms specifically tightness in the chest difficulty breathing raspy voice and a feeling of swelling in her throat. No difficulty swallowing.
57 2021-05-10 feeling hot She slept the entire day; Nausea; Headache; Her arm was sore where they gave the shot.; She felt diz... Read more
She slept the entire day; Nausea; Headache; Her arm was sore where they gave the shot.; She felt dizzy which lasted 5-6 minutes.; She had a reaction where her arms felt funny.; Her body started heating up more and more; This is a spontaneous report from a contactable consumer (patient) via telephonic call. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Apr2021 15:00 (Batch/Lot Number: EW0164) as single dose in arm left (at 57-year-old) for COVID-19 immunization. Medical history included ongoing seasonal and chemical allergies. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect, and no prior vaccinations within 4 weeks. She went to the state fair grounds. It was put on by the local agency. She gained the COVID 20lbs. She does have seasonal and chemical allergies so maybe that made her have a hypersensitive reaction to it. When she got the shot on 18Apr2021 she felt like she was fine, and then less than 5 minutes later, probably about 3 minutes later she started to feel very funny. She had a reaction where her arms felt funny. Her body started heating up more and more. She felt dizzy which lasted 5-6 minutes. She hasn't recovered completely. Then, she got dizzy and got a headache. Her arm was sore where they gave the shot. On 19Apr2021 morning, she had a tiny headache right after the shot and dizziness that went away. Her head could clear up a little more though. She had nausea and was very nauseous on 19Apr2021 night. The nausea went away after 3 hours. On 19Apr2021 (Monday), she had dizziness again. Currently, she felt fine. On 20Apr2021 (Tuesday), she slept the entire day. She didn't wake up until 4. She got the vaccine in her left arm which is the side she sleeps on. She went and got a physical before the vaccine to make sure she was in good shape. She did not go to the ER or physicians office. No relevant test. The outcome of events nausea, and headache was resolved on 19Apr2021; of event vaccination site pain was resolved on 20Apr2021; of events dizziness and feeling abnormal was resolving, while of other events was unknown. communication: The caller was provided Medical Information's number of (#), option 3, and placed in queue due to high call volumes. No follow-up attempts are needed. No further information is expected.
57 2021-05-10 feeling hot Mine mouth right side pallet gums and teeth mostly upper but sometimes lower is causing me pain hot ... Read more
Mine mouth right side pallet gums and teeth mostly upper but sometimes lower is causing me pain hot warm mouth if you cut the mouth and 3/3 I?d be 1/3 of the right side up and lower on and off throughout the days and evening warm or hot sometimes eyesocket
57 2021-05-10 flushing 1:30 PM- PATIENT STATED SHE FELT LIKE SHE HAD SOME ANXIETY RELATED TO GETTING VACCINATION AND THINK... Read more
1:30 PM- PATIENT STATED SHE FELT LIKE SHE HAD SOME ANXIETY RELATED TO GETTING VACCINATION AND THINKS SHE GOT TOO WARM IN CAR. NOTED FACE IS WARM/FLUSHED. PATIENT IS ALERT AND TALKATIVE. CUFF IS TOO SMALL FOR B/P. HR- 91, PULSE OX- 97%. 1:45 PM- 25 MG BENADRYL GIVEN ORALLY. 1:55 PM CLIENT CHOSE TO LEAVE, STATES SHE IS FEELING BETTER. LIVES NEARBY, FLUSHING DECREASED. DROVE SELF HOME.
57 2021-05-10 numbness Pain in neck, ear, and really bad headache in the base of the skull. Left arm aches and sometimes f... Read more
Pain in neck, ear, and really bad headache in the base of the skull. Left arm aches and sometimes feels numb and heavy. Sharp head pain in spot by ear. Shoulder hurts but does not hurt to move in any direction. No pain where the injection site is. Thought I was having a stroke of some kind. Didn't happen right after shot but a few days later. Swelling on side of neck and hurts to touch. Lymph nodes seems to hurt under clavicle
57 2021-05-10 numbness My left arm that I received the injecton in started to hurt the feeling with like a numbing pain it ... Read more
My left arm that I received the injecton in started to hurt the feeling with like a numbing pain it felt like it was swelling even when it didn't, matter waht I did to find comfort it didn't help; I ran a fever that felt like my body was on fire especially the left arm where I received the shot; and I also experienced hives in my left arm that rar acroos to my other arms, hands, legs and back. I also began to experience headaches that lasted through out the day.
57 2021-05-10 migraine, weakness Fever 101 Chills 11 a.m. 5/7/21 Nausea from noon - 9 p.m. 5/7 Extreme chills and weakness 5 p.m. la... Read more
Fever 101 Chills 11 a.m. 5/7/21 Nausea from noon - 9 p.m. 5/7 Extreme chills and weakness 5 p.m. lasted until 9.p.m. tylenol Massive headache both 5/7, evening of 5/8 and 5/9 evenings only. Excedrin Migraine Exhaustion
57 2021-05-10 pain in extremity Right Arm pain for two days only. Still having side effects going on 4 th day symptoms listed: He... Read more
Right Arm pain for two days only. Still having side effects going on 4 th day symptoms listed: Headaches, Dizzy, Nausea, leg pain (both) , stomach pain, - feels like motion sickness but not on a boat.
57 2021-05-11 pain in extremity Customer c/o pain in her left arm right after receiving the shot. Customer stated it was very bad p... Read more
Customer c/o pain in her left arm right after receiving the shot. Customer stated it was very bad pain that just hit at once. Code Red called and EMS and Nurse responded. Vitals taken. BP 104/72, O2 99, HR 94.
57 2021-05-12 bell's palsy Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old fema... Read more
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 57 years, administered in Arm Left, on 12Mar2021 14:00 (Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included High Blood Pressure. The patient was not pregnant at time of vaccination. Concomitant medications included labetalol; furosemide; spironolactone. The patient previously took naproxen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Bell's Palsy (medically significant) on 16Mar2021 21:00. The adverse event result in "Emergency room/department or urgent care". The patient received treatment of steroids and antibiotics for event. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. Event outcome was recovering.
57 2021-05-12 migraine pt had allergic reaction. migraines, swelling of lips and face, itchiness all over body started 5/... Read more
pt had allergic reaction. migraines, swelling of lips and face, itchiness all over body started 5/11/2021- still occurring today 5/13/2021
57 2021-05-13 difficulty speaking April 19 had off and on headache ,chills, coughing, all normal side effects; April 20th uncontrollab... Read more
April 19 had off and on headache ,chills, coughing, all normal side effects; April 20th uncontrollable cough started took otc cough syrup for that week trying to get rid of it; April 24th up all night coughing went to er at 4 am. Voice was about gone by this time. They did bloodwork, chest xray, ekg all of which were normal. Sent me home with benzonatate. Did not help voice or cough. April 28th still no voice at all and coughing. Went to primary dr. Prescribed promethazine. Took this for about 3 days. Cough was gone. Still no voice. Went to ear nose throat dr. On May 11. He prescribed Amoxicllin and prednisone. After 3 days of taking voice is slowly starting to come back. During this whole.process muscles in arm and shoulder where shot was given has been very painful off and on. Pain went away when last.prescriptions were started.
57 2021-05-13 pain in extremity Approximately 3 days after I received this second COVID vaccine, all the joints in my body (neck, sh... Read more
Approximately 3 days after I received this second COVID vaccine, all the joints in my body (neck, shoulders, elbows, wrists, fingers, hips, knees, ankles, and toes) experienced swelling and significant pain. The worst was the left arm where I had received the second vaccine shot. Despite Prednisone tapers and NSAIDS, the pain and swelling continue, particularly on the left arm side. I cannot even straighten three of my left hand fingers and cannot make a tight fist to this day. If the vaccine did not cause this directly, then it triggered a significant Sjogren's flare that has not been alleviated with the usual medications that have worked in the past with joint pain. This is worse than any flares I have had previously. I already submitted an adverse report about the sudden abscessing of my right breast cyst that had been sitting there for decades after the first COVID shot. I believe these events are related to the vaccine.
57 2021-05-14 pain in extremity Rotator cuff tear; Frozen shoulder exacerbated; Bone spur; Torn muscle; Post procedural swelling; Pa... Read more
Rotator cuff tear; Frozen shoulder exacerbated; Bone spur; Torn muscle; Post procedural swelling; Pain in arm; Fatigue; Rheumatoid arthritis flare up; Itchy throat; Seasonal allergy; Postoperative complication; Mobility decreased; Cough; This is a solicited report received from a contactable consumer reporting for herself and based on the information received by Pfizer. Solicited report from a 57-year-old female consumer with events of worsening of right shoulder torn rotator cuff, worsening of right frozen shoulder, worsening of right upper arm bone spurs and right arm bicep muscle were torn and non-serious rheumatoid arthritis flare up, limited mobility was on a sling due to shoulder surgery, itchy throat due to seasonal allergy, cough, sore arms and fatigue with HUMIRA (adalimumab). The patient had a relevant medical history of right frozen shoulder, right shoulder torn rotator cuff and right upper arm bone spurs. On unknown dates, the patient experienced worsening of right shoulder torn rotator cuff, worsening of right frozen shoulder, worsening of right upper arm bone spurs and right arm bicep muscle were torn. In 2021, the patient experienced limited mobility was on a sling due to shoulder surgery, itchy throat due to seasonal allergy and cough. On 30Mar2021, the patient experienced rheumatoid arthritis flareup. On 02Apr2021 the patient experienced sore arms and fatigue. In Apr2021, the sore arms and fatigue resolved. COVID-19 vaccine was also considered suspect. The patient stated that she probably had the right shoulder torn rotator cuff, right frozen shoulder and right upper arm bone spurs a couple of years before starting on HUMIRA and it got worsen after starting on HUMIRA. She had the shoulder surgery done on 24Feb2021 to repair the torn rotator cuff and the frozen shoulder. During the surgery, it was found that her right arm bicep was torn and was also repaired. Bone spurs was being shaved off. She was taken off HUMIRA for a total of five weeks. She experienced rheumatoid arthritis flare up as manifested by joint pain and swelling of her right hand's two finger and knuckles. She stated that it started after she had her physical therapy. She was on a sling to immobilize the operated side. The alternative etiology of right shoulder torn rotator cuff was reported as work or activity related and age-related wear and tear. The alternative etiology of rheumatoid arthritis flares up was reported as due to being taken off HUMIRA for a total of five weeks and alternative etiology of limited mobility was reported as she was on a sling due to shoulder surgery. The alternative etiology of itchy throat was reported as seasonal allergy. The alternative etiology of sore arms was reported as relate to COVID-19 vaccine. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 02Apr2021, patient received 1st dose COVID-19 vaccine manufactured by Pfizer BioNTech, lot number ER8734. Primary reporter did not have the lot number information, because the packaging was discarded (as reported). The patient was treated with prednisone. The patient's past medications include: penicillin for unknown indication. Causality for HUMIRA (adalimumab) The reporter's causality for the events of worsening of right shoulder torn rotator cuff, worsening of right frozen shoulder, worsening of right upper arm bone spurs, right arm bicep muscle was torn, rheumatoid arthritis flares up, limited mobility was on a sling due to shoulder surgery onset in 2021, itchy throat due to seasonal allergy onset in 2021, cough, sore arms, andfatigue with HUMIRA (adalimumab) was no reasonable possibility. The reporter's causality for the events of itchy throat due to seasonal allergy onset in 2021 and limited mobility/was on a sling due to shoulder surgery onset in 2021 and Post procedural swelling was not provided. Company opinion is that there is no reasonable possibility that the events of worsening of right shoulder torn rotator cuff, worsening of right frozen shoulder, worsening of right upper arm bone spurs, right arm bicep muscle were torn, rheumatoid arthritis flare up, limited mobility was on a sling due to shoulder surgery onset in 2021, itchy throat due to seasonal allergy onset in 2021, cough, sore arms, fatigue, limited mobility/was on a sling due to shoulder surgery onset in 2021 and Post procedural swelling are related to HUMIRA (adalimumab). Relevant laboratory and other diagnostic tests: 19Jan2021 shoulder magnetic resonance imaging: right shoulder torn rotator cuff, right frozen shoulder and right upper arm bone spurs. Change history: On 05Apr2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, treatment drug information, past drug information, laboratory and diagnostic procedures and narrative description. The events of 'worsening of right frozen shoulder', 'worsening of right upper arm bone spurs', 'right arm bicep muscle were torn', 'rheumatoid arthritis flare up', 'limited mobility was on a sling due to shoulder surgery', 'itchy throat due to seasonal allergy', 'cough', 'sore arms' and 'fatigue' were added. The event of 'surgery' was amended to 'worsening of right shoulder torn rotator cuff'. The event of 'swelling in right finger' was removed. The reporter considered that there was a reasonable possibility that the reported events Pain in arm and Fatigue were related to BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine. The reporter's assessment of the causal relationship of the other reported events with BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the Company causality assessment.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that events Pain in arm and Fatigue were related to suspect drug. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.
57 2021-05-15 pain in extremity 1 st shot: Swelling in arm/Pain, headache. Tired, Muscle aches. lasted 2 days. (No Fever). 2 nd shot... Read more
1 st shot: Swelling in arm/Pain, headache. Tired, Muscle aches. lasted 2 days. (No Fever). 2 nd shot: Swelling in arm/Pain, Extreme Headache, Fever 101.5, Extreme muscle aches, nausea, vomiting. These symptoms lasted 2 days.
57 2021-05-15 tingling, weakness, pain in extremity, burning sensation In addition to just usual arm pain and tired on day on vaccine #1 12/23/2020; after 24 hrs had sudde... Read more
In addition to just usual arm pain and tired on day on vaccine #1 12/23/2020; after 24 hrs had sudden onset extreme weakness, brain foggy, anorexia, extreme sleepiness, my weakness prevented me to continue typing my notes using my hand and walking out of room, made me immediately turn back to rest. Took 20mg prednisone and slept. Symptoms resolved after 2 hrs of sleep in chair in office. Next day took usual dose 2mg back. Doing ok but then after few days (Lee?s than a week) had paresthesia like (burning needle pin) migratory on different parts of upper and lower extremity. No motor weakness. This has gone on even after 2nd vaccine. 1/13/2021. It got better in February but then came back in April with increased frequency and intensity with small blisters on firearms both sides where burning sensations felt. Now it also made me feel weak, sleepy, hands and feet Paine with mild spindle like puffiness of fingers with pain on pip more than mcp. Had to increase prednisone 10mg a day and felt tolerable but wheN go below 5mg, the pain of hand and feet and frequency of dysesthesis and blister was not well tolerated to do my routine work
57 2021-05-15 tremor Achy/Sore muscles all over my body including feet, ankles, hands. Lethargy and extreme chills for ... Read more
Achy/Sore muscles all over my body including feet, ankles, hands. Lethargy and extreme chills for 4 hrs . Involuntary shaking for about 45 min at about 2:30-3:30 am. Headache.
57 2021-05-16 nerve pain Got Shingles, received Valacyclovir antibiotics, shingles went away after 3 weeks. Still have occasi... Read more
Got Shingles, received Valacyclovir antibiotics, shingles went away after 3 weeks. Still have occasional nerve pain.
57 2021-05-17 breast pain I fainted at the facility I was at 10 minutes after the shot. I've since had burning at the injectio... Read more
I fainted at the facility I was at 10 minutes after the shot. I've since had burning at the injection shot (daily, months later) and a pain in the left side of my breast. I am often dizzy with the ground feeling like it's moving. I fainted a second time after a dizzy spell a few weeks after the second shot/fainting episode. My heart is often racing post getting the vaccine.
57 2021-05-17 numbness, pain in extremity, muscle spasms I experienced sever pain to my left arm with swelling. The pain radiated from, my left arm to my nec... Read more
I experienced sever pain to my left arm with swelling. The pain radiated from, my left arm to my neck, head and all the way down to my fingertips. I also had numbness sensation. I tool Tylenol for pain and an anti-inflammatory medication. I did continue to have unexplained muscle spasm and fatigue. I went to see my PCP to evaluate my fatigue and muscle spasm that has not resolved.
57 2021-05-18 weakness This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 10:45 (Lot Number: ER8733) as SINGLE DOSE for covid-19 immunisation. Prior Vaccinations within 4 weeks, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Medical history included she was a breast cancer survivor, it's been 10 years, all she had was radiation and she also had Tamoxifen for 5 years. When she was young, she would get vaccines and would always get a light fever and her arm would swell and turn red. She verified she had this type of reaction with any vaccine she received. She also had a colonoscopy a couple of months ago. The patient's concomitant medications were not reported. She got a very bad headache on 02Apr2021, she woke up in the middle of the night and she got up, she thought her head was going to explode. She fainted on 03Apr2021 for just a few seconds, so she went to the emergency room on 03Apr2021 and they gave her a CAT scan, with dye and one without dye and everything was normal. They gave her some Advil through her IV to get rid of the headache and then she was okay. She said the night before she had a headache, she took a baby aspirin and she was better and went to sleep. Patient stated around 1 AM in the morning, she woke up and wasn't feeling well. She got up, she had a really bad headache, throbbing, seemed like it was going to explode, and she went to the bathroom. She called out to her sister, she was not feeling well and she lost consciousness there. A few hours later, her sister helped her to the living rom and she could not walk by herself, she was weak. She ate something later, she drank a lot of Gatorade and she got in touch with the nurse and the nurse told her to go to the emergency room they performed tests at the ER. She did not have any more headaches, the throbbing headache went away but the headache didn't completely go away. In the emergency room after all the testing, the doctor told her they were going to give her something similar to Advil through her IV and the headache went away. The fainting only happened that one time and ended right then and there, she thought because the headache was so bad. Patient reported her heart rate was very fast. She stated they waited for her heart rate to stabilize they gave her Advil through the IV, the headaches went away and she slept and they allowed her to go home once everything was okay. Between the first and second doses patient was sensitive to hot and cold foods, she couldn't drink a hot cup of coffee. She thought she had a cavity, it was strange. She was eating everything lukewarm. She felt sharp pain on her right side. So she went to the dentist and the dentist thought it was more of a vein problem, they took x-rays and found two cavities and a cracked tooth, and they fixed it. First Visit to emergency room, CAT scan with and without dye, COVID test, EKG, Lung X-ray. Everything came back normal, it was negative. Patient has recovered completely from the headache on 03Apr2021 thanks to the Advil. She confirmed she recovered completely from the fainting on 03Apr2021. The outcome of other events was unknown.
57 2021-05-18 bell's palsy Bell's palsy; eyes pretty red; runny nose: second dose; eyes started bothering her, the right eye: s... Read more
Bell's palsy; eyes pretty red; runny nose: second dose; eyes started bothering her, the right eye: second dose; her eye had a little burning sensation and was irritated; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 11:30 (Batch/Lot Number: EW0151) as single dose for covid-19 immunization. The patient's medical history included she was a breast cancer survivor, its been 10 years, all she had was radiation and she also had Tamoxifen for 5 years, had a colonoscopy a couple of months, she had seasonal allergies, adverse event following prior vaccinations: when she was young, she would get vaccines and would always get a light fever and her arm would swell and turn red. The patient's concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: ER8733) in left arm on 24Mar2021 10:45 for covid-19 immunization and experienced fainted for just a few seconds, heart rate was very fast and headache, wasn't feeling well and lost consciousness. The patient experienced bell's palsy on 01May2021, eyes started bothering her, the right eye, her eye had a little burning sensation and was irritated on 29Apr2021, on the 30Apr2021 eye was pretty red, runny nose on 30Apr2021. The clinical course as following: This past Wednesday was two weeks and then Thursday, her eyes started bothering her, the right eye. She thought it was seasonal allergies, because she has those, that kept bothering her and and she had a very runny nose. Saturday she woke up she felt like her face was kind of numb. She called the nurse and they told her she should go to the emergency room. She was diagnosed with bells palsy and so they gave her treatment and they explained to her what it was all about. She had been working out in the yard and she came in and her eye had a little burning sensation and was irritated. She thought it was because she was outside. She also had a runny nose. She says again, she thought it was seasonal allergies because she has that. Felt weird around her mouth, felt kind of numb: second dose: This past Saturday, she woke up and stated she felt weird around her mouth, it felt kind of numb, it was hard for her to drink, she couldn't smile correctly, her smile was lopsided, one side was droopy. Caller states this began 01May2021. She went to the emergency room that same day and they diagnosed her with bells palsy. She was discharged from the emergency room because this time the lady doctor gave her the procedure with a stroke. The doctor could tell that it was not a stroke because of the eye, the doctor did something with her finger, they say can you see my finger, can you touch your nose. The doctor told her what she had is bells palsy and prescribed some medication. The eye is worse, but she doesn't have a runny nose anymore. With her eye, she can raise the left one, but the right one not as much. They gave her a patch for the right eye. She has to wear it in the evening, because it doesn't close anymore. She has to wear it to sleep with and during the day she has to wear glasses and if she goes outside, she has to wear sunglasses. Her eye is not really irritated, just kind of stiff, it does not really do much, she did some exercises to try to stimulate the muscles. The eye is just there, it doesn't really blink, it is beginning to blink a little bit but when she tries to close both eyes, she can close the left but it's like she can't completely close the right, she has no control of that part of the face, it's numb. She clarifies her eye started on Thursday 29 Apr because it was the first day she was outside. on the 30 Apr it was pretty red but she kept working. On Saturday morning she worked and she had a runny nose then too. Caller states they gave her some medicine at the emergency room. That night, she took Acyclovir and after she took the first one, she didn't have a runny nose anymore. Her eye is a different kind of bother now, it doesn't burn, its just there. They told her to get artificial tears and put the patch on. When asked if her eye is improved, persisted or worsened, she says the eye is not burning anymore, it's just kind of stiff. Bell's palsy: Caller states it's ongoing, when she smiles its the same. Caller states it's lopsided and when she raises her eyebrows, she can raise the left one, but the right one only goes up a little bit, but not as much. Caller states it's persisting, it's not getting worse, not getting better. Caller states she just started the medicine yesterday. Acyclovir: It was 400mg 5 times a day by mouth, one tablet for 10 days. Methylprednisolone: the other thing they prescribed me was Methylprednisolone. She tried taking both the Acyclovir and the Methylprednisolone yesterday, but she had a really bad stomach ache and couldn't eat anymore. She had no appetite and her doctor, she told him she couldn't take both it is too much, so he just said she should continue the Acyclovir so she is not going to take the Methylprednisolone. The Methylprednisolone is a 4mg dose pack, 6 day thing. Yesterday she was supposed to take two before breakfast, 1 after lunch, 1 after supper and 2 before bedtime. She couldn't take all of that, it was too much. Today would have been different, it tapers off. The emergency room visit on 01May2021, they didn't do any testing, she just had observation. the doctor did this thing with her finger where she could see her finger and she pushed back and held onto the doctor's hands and showed her strength. she raised her eyes, closed her eyes, smiled, but no other testing was done. she had her second emergency room visit on 01May2021. Therapeutic measures were taken as a result of bell's palsy included Acyclovir and Methylprednisolone, for events of 'eyes started bothering her, the right eye', 'her eye had a little burning sensation and was irritated', and 'eyes pretty red' included artificial tears and put the patch on, no treatment received for runny nose. The outcome of the event Bell's palsy was not recovered, the outcome of the event runny nose was recovered on 01May2021, the outcome of the other events was recovered on an unknown date.
57 2021-05-18 burning sensation Immediately after receiving the vaccine, patient began complaining of a metallic taste in her mouth;... Read more
Immediately after receiving the vaccine, patient began complaining of a metallic taste in her mouth; burning of her tongue and lips; swelling of lips; burning of hands and feet; and tinnitus.
57 2021-05-18 hot flush, weakness Initially fever light headed week shortness of breath. By Sunday March 21, 2021 sob, cough, blood p... Read more
Initially fever light headed week shortness of breath. By Sunday March 21, 2021 sob, cough, blood pressure shot up to 200/100. Throat makes this involuntary clearing sound and hot sweats. Still have everything but fever and high blood pressure.
57 2021-05-18 numbness, speech disorder Numbness; Swelling occurred in the area between my mouth and chin on the left side of my face; When ... Read more
Numbness; Swelling occurred in the area between my mouth and chin on the left side of my face; When touching the area there is a lump that measures between an inch and two; Speech is weird; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration on 03Mar2021 04:00 PM in the left arm at 2nd dose, single for COVID-19 immunisation. The patient age at vaccination was 57 Years. Medical history included IBS (inflammatory bowel disease) and recently the patient was developed a sensitivity to shrimp that results in hives. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot number: EL9282) received in left arm on 10Feb2021 05:00 PM for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine and not received other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination and after the vaccination. On 05Mar2021 7:15 AM, the patient had swelling occurred in the area between my mouth and chin on the left side of my face up and my speech is weird. It almost feels like I went to the dentist and got a shot of novocaine in that area. When touching the area there is a lump that measures between an inch and two. I took two Benadryl at 7:35 or so and the swelling has started to decrease but is still there, as well as the numbness. Therapeutic measures were taken as a result of numbness (hypoaesthesia), swelling occurred in the area between my mouth and chin on the left side of my face (swelling face), when touching the area there is a lump that measures between an inch and two (mass) with Benadryl and novocaine. The patient reported that she do not know if this was happened before but potentially having a reaction to the vaccine that she got on Wednesday part of face has swelled up. Outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
57 2021-05-19 burning sensation, tremor Heart palpitations body shaking lost of weight headache. Went to the emergency room on 4/19/2001 I w... Read more
Heart palpitations body shaking lost of weight headache. Went to the emergency room on 4/19/2001 I was the diagnosed with Graves disease I am now on medication. I now have suffered with burning and swelling in my arms and hands I am back in the hospital. I have been very sick since vaccine was administered
57 2021-05-19 feeling hot After my 30 minute observation period, I left the facility. Shortly after leaving the Campus, I felt... Read more
After my 30 minute observation period, I left the facility. Shortly after leaving the Campus, I felt my lips begin to tingle and noticed my face was hot and turning red. As I was pulling over to the side of the road to pull medication from my purse, my symptoms increased and my tongue began to swell. I took two Benadryl gel-caps and waited to see if my symptoms would calm or if I would need my epi pen . The Benadryl calmed the response and I continued home. This was approximately 40 minutes after my vaccination. When I have an anaphylactic reaction to pork, tuna, or shell fish, the reaction time is typically much closer to the event, but the reaction sequence is similar.
57 2021-05-19 pain in extremity, burning sensation No prior reaction ever experienced from a vaccine or shot before other than slight pain in my arm. ... Read more
No prior reaction ever experienced from a vaccine or shot before other than slight pain in my arm. This time, I experienced severe burning and pain in left arm that traveled down the arm immediately after the shot was received causing tears to my eyes. Also experienced a short bout of heart palpitations. Burning dissipated over the course of the day. Pain in arm lasted 2 weeks with it still being tender as of today when palpitated.
57 2021-05-20 pain in extremity 5/15/2021, 10:45 am-Twinge in left side of neck muscle; 1:30 pm-mild headache, lower back pain left ... Read more
5/15/2021, 10:45 am-Twinge in left side of neck muscle; 1:30 pm-mild headache, lower back pain left side only; 3:30 pm-plantar fasciitis pain left foot only; 5:39 pm- mild body aches left side only; overnight during sleep-moderate body aches entire body. 5/16/2021- woke up with severe headache, moderate body aches whole body, mild chills whole body; plantar fasciitis pain left foot only continued; 1:30 pm-fever 100.2; mild to moderate nausea througout rest of day;these symptoms continued for about 24 hours. 5/17/2021- previous days symptoms subsided late morning; 11:00 am-feel like left collar bruised; 4:00 pm-discover lump left side of neck above collar bone. 5/18/2021-Wake up with moderate headache and nausea which supplies by late morning. Lamp on left side of neck by collarbone still there. 5/19/2021-lump on left side of neck still there; pain underneath left arm,. 5/20/2021-lump on left side of neck still there; pain underneath left arm, tweaking pain inside left thigh, left armpit near lymph node occasional pain and tender. 5/22/2021-woke up to severe headache and nausea which subsided by noontime. L ump on left side of neck still there.
57 2021-05-21 numbness Waited 15 minutes afterwards with no problems, however, about a half hour later (once I was almost ... Read more
Waited 15 minutes afterwards with no problems, however, about a half hour later (once I was almost home) I had puffed toes, a lower back ached, significantly numb lips and numbness around jaws and cheek area. No problems with breathing. Just thought I'd ride it out. However, within 48 hours I had a strong streaky rash with itching across the front of my neck, and itching on both jaws with small bumps appearing. Tried to manage it on my own and was soon after needing to travel. I took an antihistamine daily and used Cortaid topically until returning in hopes it would subside. When I returned I began to try to get a medical appt via telehealth and sent them images of rashes and the issues. I finally got an appt. with doctor and by May 19 I began using prednisone protocol, along with antihistamine, flonase and otc pepcid due to some ingredient in that the doctor said would help. Must return to doc in 2 weeks to see how symptoms are doing. Please note that the vaccine dose 2 also increased my tinnitus sounds. Please include this in some study. I'm not hesitant to get the booster down the road! contact if you need more info.
57 2021-05-21 migraine Day after vaccine shoulder and neck pain. Third day ringing and hearing loss in left ear. Progressi... Read more
Day after vaccine shoulder and neck pain. Third day ringing and hearing loss in left ear. Progressively worse at 1 week and 2 weeks. Third week, went to er, shoulder treated for inflammatory process, migraine treated, never had a migraine before, referred to ENT. Saw ent 2 days later, diagnosed with sensorineural hearing loss and tinnitus. Received 2and dose of vaccine in right arm on May 20, 2021. Ringing started in right ear today, May 22,2021.
57 2021-05-21 tremor Patient was very anxious prior to vaccine. Patient came tremoring and anxiety Water was provided Dis... Read more
Patient was very anxious prior to vaccine. Patient came tremoring and anxiety Water was provided Discharged to home
57 2021-05-22 migraine, pain in extremity, cold extremities, tingling, numbness 4/3 started experiencing tingling and numbness on left side of body leg and arm initially it was int... Read more
4/3 started experiencing tingling and numbness on left side of body leg and arm initially it was intermittent but has progressed to daily occurring. On 4/6 called doctor and advised them of my symptoms and the doctor ordered full blood work up. On 4/9 called and scheduled video app to speak to my regular PCP she stated that if blood work came back normal and symptoms persisted then would refer to neurologist. 4/13 experienced ocular issues along with continued tingling and numbness called doctor and they told me to go to ER. ER doctor thought I was having a migraine. 4/21 started experiencing pressure in my chest. 4/29 had video call with neurologist who requested that I get an MRI. Both PCP and Neurologist stated that I should still get 2nd dose of vaccine which I did on 5/6/21 next day started to experience waves of pressure and feeling like I was going to pass out. This occurred intermittently and then on 5/17 it last several hours along with hands and feet being very cold to the touch and throbbing in my left calf I went to the ER by the time I was seen in the ER the feeling of passing out had subsided.
57 2021-05-22 pain in extremity After first vaccine, no reaction other than sore arm. After second vaccine, received May 10 at 10:30... Read more
After first vaccine, no reaction other than sore arm. After second vaccine, received May 10 at 10:30 AM. Awakened morning of May 12 with heartburn and low fever (99.9). Heartburn became moderate to severe stomach cramps , headache, body aches, and low flow urination with more cramps. Fever rose, was 101.2 at highest. Cramping was debilitating until around 4PM on 5/14, when they became mild to moderate, more like gas pains. Fever came down , from then on hovered between normal and around 100. Still low flow urination, and I was drinking a ton of water. My abdomen was very bloated and constantly loudly gurgling , rumbling, etc. Status quo through the weekend, on Monday I went to Urgent Care . Urgent Care performed covid test and urinalysis , guessing I may have UTI. There was a little blood found in my urine but all tests came back negative. At this point I developed post nasal drip and a constant hacking cough. Status quo through that week , on Friday 5/21 I went to see my regular practioner. She couldnt find anything , referred me to gastroenterologist who I will see next week. Urination is better now, fever seems gone but I am still coughing and experiencing mild gas pain like cramping
57 2021-05-23 nerve pain, pain in extremity Marked nerve pain along spine/back and back of arms, plus fever blisters on lips
57 2021-05-23 pain in extremity Inflamed joints. Big toe on left foot. Both thumb joints are inflamed and very sore. Right side thum... Read more
Inflamed joints. Big toe on left foot. Both thumb joints are inflamed and very sore. Right side thumb is worse. Knees inflamed.
57 2021-05-24 facial paralysis, flushing Dilation swelling in throat minutes after vaccination. Also became nauseated and light headed minute... Read more
Dilation swelling in throat minutes after vaccination. Also became nauseated and light headed minutes afterward. Had to lie down at home. About 2 to 3 hours later. Right side of face flushed/light rash and right eye drooped and almost closed. Stayed this way for about 3 hours before eye started to resume to normal. Didn't affect left side of body.
57 2021-05-24 pain in extremity Patient experienced soreness in arms and legs and eventually suffered a stroke
57 2021-05-25 numbness Facial numbness and slight drooping of eyes occurred about an hour after receiving the vaccine. It h... Read more
Facial numbness and slight drooping of eyes occurred about an hour after receiving the vaccine. It has gone almost back to normal as of today 5/26/21.
57 2021-05-25 night sweats I was sick with nausea, vomiting, headache, muscle aches, extreme exhaustion, and feeling extreme ho... Read more
I was sick with nausea, vomiting, headache, muscle aches, extreme exhaustion, and feeling extreme hormonal changes like extreme night sweats. Worse than anything I ever had during menopause. I was in bed for 1 week, and feeling sick for 2 weeks. I am still suffering with extreme night sweats almost 2 months later.
57 2021-05-25 pain in extremity sore right arm; Headache; This is a spontaneous report from a contactable Consumer or other non-HCP,... Read more
sore right arm; Headache; This is a spontaneous report from a contactable Consumer or other non-HCP, the patient. A 57-Year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration in the right arm on 09Mar2021 at 03:15 PM (at the age of 57-years-old) as a single dose for COVID-19 vaccination. The patient's medical history include histoplasmosis in teenage years. It is unknown if patient took any medications for histoplasmosis. Patient has not tested positive for COVID-19 before receiving vaccine. Concomitant medications include Estradiol testosterone 2mg 5 mg (MANUFACTURER UNKNOWN) and Progesterone 200 (MANUFACTURER UNKNOWN) which patient has taken within 2 weeks of vaccination for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not allergic to medications, food, or other products. Patient has not tested positive for COVID-19 since receiving the vaccine. On 10Mar2021 patient experienced very sore right arm which resolved after applying ice pack on right arm. Patient also experienced bad headache off and on for a week. It was painful and it hurt to touch on both sides of forehead which then extended to sinus area above forehead. Therapeutic measures taken included Tylenol (MANUFACTURER UNKNOWN) and Extra strength Excedrin (MANUFACTURER UNKNOWN). The clinical outcome of sore right arm was recovered and for headache was recovering. Information about lot/batch number cannot be obtained. No further information is expected.
57 2021-05-25 pain in extremity Pfizer-BioNTech Covid-19 Vaccine EUA Injection Site Pain radiating down to hand -2 days - Advil fir... Read more
Pfizer-BioNTech Covid-19 Vaccine EUA Injection Site Pain radiating down to hand -2 days - Advil first day - no relief - Tylenol tiredness - 36 hours headache -72 hours - Tylenol day 2 and 3 muscle pain and aches in legs - 72 hours chills - first 48 hours Joint pain - 48 hours Fever to 100.4 first 48 hours injection site swelling and hot to the touch 48 hours nausea - 72 hours dizzy - 72 hours feeling unwell 72 hours
57 2021-05-26 breast pain Breast pain; Neck pain; Swelling in armpit; Shoulder pain; Pain in armpit; This is a spontaneous rep... Read more
Breast pain; Neck pain; Swelling in armpit; Shoulder pain; Pain in armpit; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number: UNKNOWN), via unspecified route of administration on 02Mar2021 at 09:30 (at the age of 57-years-old) as unknown single for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included other medication used in 2 weeks. The patient did not have any allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced armpit pain, shoulder pain, swelling arm, pain neck and breast pain on 02Mar2021 at 15:00. No therapeutic measures were taken for armpit pain, shoulder pain, swelling arm, pain neck and breast pain. Outcome of event of armpit pain, shoulder pain, swelling arm, pain neck and breast pain was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-05-26 facial pain, numbness It started with a headache the next day and pain in my jaw Then overtime this progressed to numbnes... Read more
It started with a headache the next day and pain in my jaw Then overtime this progressed to numbness in the right side of my face and tinnitus, Which then progressed to Jaw locking, pain and pressure in my face, and feeling like the nerves in my face are on fire Over a month later I still have the symptoms and the jaw walking has only gotten worse
57 2021-05-27 migraine 1. extreme chills (but no fever) beginning at 3:30 pm, 2. nausea beginning at 10 pm followed by one... Read more
1. extreme chills (but no fever) beginning at 3:30 pm, 2. nausea beginning at 10 pm followed by one episode of 3. vomiting at 11:00 pm, nausea continued throughout the evening, 4. severe body aches beginning early the next morning - 5. severe pain in spine caused inability to walk or move without pain for two days (pain upon moving was unbearable- to realize later I had some inflammation in my spine as a result of vaccine). 6. migraine 7. spinal pain and migraines have taken two months to return to pre-vaccine levels (I had NO spinal pain prior to vaccination)
57 2021-05-27 pain in extremity Day 1: Sore arm Day 2: low grade fever of 99.7, Day 3: low grade fever 99.5 and woke up with extreme... Read more
Day 1: Sore arm Day 2: low grade fever of 99.7, Day 3: low grade fever 99.5 and woke up with extreme vertigo which lasted 2 days. Could not get out of bed. Also felt like my head was congested and ears clogged, but did not have a cold. I have allergies, but clogged ears is not something I've ever experienced with them. I did take Benadryl to try and help that. Day 5: continued to experience dizziness which has gotten better each day. I'm still experiencing dizziness when I move my head too quickly or stand up. It's livable, but wish it would go away. Haven't seen a doctor, just living with it. I had vertigo and nausea on day 6 of my first vaccine so the side effect was consistent. Just don't understand why it happened.
57 2021-05-27 seizure, coordination abnormal passing out/sort of out of body-ish awareness; Patient had never had a seizure, but it felt more lik... Read more
passing out/sort of out of body-ish awareness; Patient had never had a seizure, but it felt more like that than a faint; Felt heavy in upper arms/chest; Felt heavy in upper arms/chest; feeling uncoordinated walking through house; felt out of body; felt pain in knees/pain in right knee; joints seizing/cracking really hard; abrasions on both of knees; Moderate damage to L mcl; Must have fallen; stinging spot in the back of head; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171) via an unspecified route of administration, administered in arm left on 01May2021 09:00 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included leukemia from 1998, breast cancer from 2001. No Known allergies. Concomitant medications were not reported. The patient previously received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0164) on 10Apr2021 08:00 AM (at the age of 56-year-old) in left arm for Covid-19 immunization, then experienced adrenal disorder and epinephrine increased. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient woke up Tues, 04May2021 08:00 AM. Felt heavy in upper arms/chest. Started feeling uncoordinated walking through house. Didn't remember actually passing out but felt out of body and felt pain in knees, and joints seizing/cracking really hard. sort of aware something was happening, but sort of out of body-ish awareness. Came back to awareness. abrasions on both of knees, moderate damage to L mcl. pain in right knee. must have fallen but no awareness of that - came to laying on back. Patient had never had a seizure, but it felt more like that than a faint. Also noticed a stinging spot in the back of head that seemed to travel up the back of skull for several days. Treatment was not received for the adverse event. Reporter assessed events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "passing out/sort of out of body-ish awareness" was recovered in May2021, of other events was unknown.
57 2021-05-29 weakness Patient is a 57 year old woman works as a cleaner with PMHx morbid obesity, HTN (on amlodipine, meto... Read more
Patient is a 57 year old woman works as a cleaner with PMHx morbid obesity, HTN (on amlodipine, metoprolol, triamterene-HCTZ), CKD3 (baseline Cr 1.1-1.2) who presented to the ED on 5/28 with worsening shortness of breath, cough with yellow sputum, fatigue, and weakness, found to be COVID-19 positive. She was subsequently admitted to the MICU for acute hypoxic respiratory failure. At baseline, she is independent in all ADLs and works as a cleaner at an office building. She got the first dose of the pfizer COVID vaccine series 5/10, scheduled for second dose 6/2. She lives with her husband and nephew in a house with additional family members who live downstairs. She says she only really goes to work and always wears a mask while there. Her daughter (lives downstairs) helps with grocery shopping. No recent travel or sick contacts that she is aware of. She was in her usual state of health until 5/22 when she said she started to feel poorly. She had increasing shortness of breath over the next few days with worsening fatigue and cough to the extent that she was considering calling off from work. She continued to feel poorly and decided it was time to go to the ED on Friday, 5/28. Today, she says she is feeling better and is less short of breath. She still has coughing that is occasionally productive for clear sputum. No fevers, chills, lightheadedness/dizziness, chest pain, abdominal pain, nausea, vomiting, diarrhea. Her appetite is improved, and she is eating and drinking better today. Patient is a 57 year old female with PMHx obesity, HTN, CKD3 who presented to the ED with shortness of breath, cough, fatigue, found to have COVID-19. In the ED, she was hypoxic requiring increasing amounts of oxygen, ultimately with 40% FiO2 via Ventimask and HFNC when admitted to the MICU. CT chest with GGO/patchy consolidation in posterior lung areas and bases as is typically seen with COVID-19 infection. She has been started on remdesivir and dexamethasone and is now requiring HFNC for oxygen supplementation. Likely her single dose of vaccine has helped to lessen her disease severity. She meets criteria for addition of tocilizumab. Recommendations: - Continue dexamethasone and remdesivir - Can add tocilizumab - Health care maintenance: Screened for HIV 2009, HCV 2018, HBV 2018. Last TDAP 2015. I saw and examined the patient. I strongly agree with the resident/fellow's findings and plan of care. Patient with risk factors for severe Covid including obesity underlying kidney disease and hypertension presents with fever fatigue malaise and infiltrates on chest CT a little over 2 weeks after initial mRNA vaccination Denies any anosmia Agree with current treatment plan including dexamethasone and 5 days of remdesivir duction and maintenance and okay for tocilizumab as she is less than 24 hours into the ICU Other health maintenance up-to-date HIV negative remote hepatitis negative I will ask lab for cycle threshold out of curiosity as she has been vaccinated which likely has mitigated severe disease Explained to patient in detail and questions answered. Spoke to ICU team please call back if questions
57 2021-05-31 weakness, unresponsive to stimuli, slurring, involuntary muscle movements, tingling, facial paralysis Patient complaining of a pricking needles to head. At 10:30, patient was constantly jerking and not... Read more
Patient complaining of a pricking needles to head. At 10:30, patient was constantly jerking and not responding to questioning. Episode lasted 2 minutes. 911 called. Placed patient in supine position and at 10:30 patient showed visible signs of not breathing, holding throat, gasping for air. EpiPen given. Patient transported to ED at 11:17. Upon arrival to ED at 11:19 am, left sided facial droop and weakness with slurred speech and complaints of a severe headache noted. Patient received keppra 3000 mg intravenous x 1 dose at 1211. Patient was discharged from emergency department 5/28/21 at 1330 with prescription for keppra 500 mg by mouth twice daily and ambulatory referral to neurology.
57 2021-05-31 numbness Increased blood pressure, increased HR, sweating, numb hands
57 2021-05-31 numbness Tongue tingling, numbness, ?mild swelling - self-resolving.
57 2021-05-31 pain in extremity Both knees tightened up, with swelling (fluid on both knees), on 04/12/21, my right index finger had... Read more
Both knees tightened up, with swelling (fluid on both knees), on 04/12/21, my right index finger had a sharp shooting pain in the mid knuckle that radiated up and down my finger. My finger swelled up and was extremely painful to touch or use. The pain increased and knuckle became itchy and tight as if I had a hive on it. The pain and swelling lasted for 9 or 10 days. Finger felt normal on or about 04/21/21. Both knees continue to be swollen and painful in front and back, with going up and down steps, and sitting down and standing up. I have not yet contacted my primary care physician. I was hoping my knee pain would go away on its own.
57 2021-05-31 tremor Eye pressure; Light headed dizzy; Limbs feel like jello and wobbly; Felt like I was floating as if I... Read more
Eye pressure; Light headed dizzy; Limbs feel like jello and wobbly; Felt like I was floating as if I was 10 feet tall; Sugar bottomed out to 80; Fast heartbeat; Shaky hands and legs; This is a spontaneous report from a contactable Other Health Professional (patient herself). A 57-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 02Feb2021, 07:30 AM (Batch/Lot Number: EL9261) as 1st dose, single for covid-19 immunization. The patient's medical history included Diabetes mellitus type 2, Fibromyalgia, Hypothyroidism, Osteoarthritis, allergies to Penicillin from an unknown date. The patient received other medications within 2 weeks of vaccination. On 02Feb2021 at 11:30 am, 4 hours after the vaccination the patient experienced Eye pressure, Lightheaded dizzy, Limbs feel like jello and wobbly, felt like she was floating as if I was 10 feet tall, Sugar bottomed out to 80, Fast heartbeat and Shaky hands, and legs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was Recovering. Follow-up attempts are completed. No further information is expected.
57 2021-06-01 facial paralysis half of face is paralyzed; vision blurry and can't see; eyes hurt and are burning; eyes hurt and are... Read more
half of face is paralyzed; vision blurry and can't see; eyes hurt and are burning; eyes hurt and are burning; vision blurry and can't see; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09May2021 (Lot Number: ER8735) as 2nd dose, single for covid-19 immunisation (reported as does not want to die) in Pharmacy. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (Lot number: W0L61 or W0161) at age of 57 years old on 18Apr2021 at right arm for Covid-19 immunization. Caller state she received the first and second shot Covid. Clarified that she is referring to the Pfizer Covid vaccine. She got the shot last Sunday, a week ago. Patient experienced half of face is parlayzed: States that it is the left side or the right, she doesn't even know any more. It started the same day she got the vaccine, last Sunday 09May2021. It is getting worse. No treatment (nothing) for it. Also reported hard to read (lot number) because her eyes hurt and are burning. Caller states that she cannot see and that her eyes hurt very bad and they are burning. She cannot see and her vision is blurry (all on 09May2021). Wanted to know what to do. Outcome of the events was not recovered.
57 2021-06-01 numbness, tingling swelling and numbness in lip and chin area of face. fingers on right hand numb, tingling sensation... Read more
swelling and numbness in lip and chin area of face. fingers on right hand numb, tingling sensation, and swelling. symptoms have lessened since this morning but still prevalent.
57 2021-06-01 nerve pain, breast pain nerve pain in left breast and nipple area, seems to be shingles pain
57 2021-06-01 pain in extremity Lot of pain in arm; Bit woozy; Hot/cold sweats; Sore back; This is a spontaneous report from a non-c... Read more
Lot of pain in arm; Bit woozy; Hot/cold sweats; Sore back; This is a spontaneous report from a non-contactable consumer or other non hcp. A 57-years-old non-pregnant female consumer (patient) reported for herself that who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on 22May2021 11:00 (Batch/Lot number unknown) (Age at Vaccination: 57 years) as unknown, single dose for covid-19 immunization. Medical history included allergic to salmonids and juniper. The patient's concomitant medications were not reported. Any other vaccines within 4 weeks prior to the COVID vaccine as unknown. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, the patient developed lot of pain in arm, bit woozy, hot/cold sweats and sore back for which she did not received any treatment. The outcome of the events was reported as recovering. No follow-up attempts are possible. No further information is expected.
57 2021-06-01 tingling, pain in extremity she sees something like she's blind; her eyes feel like she put some lemon inside her eyes; pain in ... Read more
she sees something like she's blind; her eyes feel like she put some lemon inside her eyes; pain in her eyes after the second dose; headache/painful in her head; can't take her arms in one position, she has to move around; pain in her arms is getting worse; pain in her ears; pain all over her body; muscle pain; lost her appetite; tired in the beginning, sleeping all day; tired in the beginning, sleeping all day; right side of her head, neck, back, all her arm tingles on her right; worsened when she received her second dose; right-sided back/neck/shoulder pain; right-sided back/neck/shoulder pain; right-sided back/neck/shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 12May2021 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. The patient medical history was none. Concomitant medications included colecalciferol (VITAMIN D 3); zinc; ascorbic acid (VITAMIN C ACID); ascorbic acid/ergocalciferol/nicotinamide/retinol palmitate/riboflavin/thiamine mononitrate (MULTIVITAMIN 6) from an unspecified date and ongoing (been taking them her whole life). The patient previously received BNT162B2, dose 1 administered in arm left (injection) on 05Apr2021 (Batch/Lot Number: EW0158) for COVID-19 immunization and experienced painful, tired, headache, sleep all day because she wasn't sleeping good, hard for her to look back to the right side, arm was getting painful on her shoulder/back, numb and pain came on more strong in back. The patient experienced saw something like she's blind on 15May2021 with outcome of not recovered; her eyes feel like she put some lemon inside her eyes on 15May2021 with outcome of not recovered; pain in her eyes after the second dose on an unspecified date in May2021 with outcome of unknown; headache/painful in her head on an unspecified date in May2021 with outcome of not recovered; couldn't take her arms in one position, she has to move around on an unspecified date in May2021 with outcome of not recovered; pain in her arms was getting worse on an unspecified date in May2021 with outcome of not recovered; pain in her ears on an unspecified date in May2021 with outcome of not recovered; pain all over her body on an unspecified date in May2021 with outcome of not recovered; muscle pain on an unspecified date in May2021with outcome of unknown; lost her appetite on an unspecified date in May2021 with outcome of unknown; tired in the beginning, sleeping all day on an unspecified date in May2021 with outcome of not recovered; right side of her head, neck, back, all her arm tingles on her right on an unspecified date in May2021 with outcome of unknown, right-sided back/neck/shoulder pain on an unspecified date in May2021 with outcome of unknown, all reported as worsened. Clinical course reported as follow: Patient was calling to ask if taking ibuprofen (ADVIL) or naproxen sodium (ALEVE) to treat side effects was better than taking paracetamol (TYLENOL), which was what she has been taking. Patient received her first dose of the Pfizer BioNTech COVID-19 vaccine and experienced side effects that were worse after receiving the second dose. Patient reported pain in her eyes after the second dose. Patient was very concerned about the shot she has gotten. She was in such painful. She stated the whole right side of her head, neck, her back and all her arm tingles on her right. She stated the one she got, the second one, it made her have a headache. When she got the second shot, her arm, she couldn't take her arms in one position, like when she's driving, she has to move around or something. Patient stated but something she's really concerned about was about three days ago, after she take that shot, she had such a headache, the pain in her arms was getting worse. She felt a pain in her ears, its painful/sound in her ear and stated they were painful, not all day, but sometimes, but it was getting really strong. The most concern was her eyes, when she has such a headache, it's like needles in her head, and her eyes were feeling like she put some lemon inside her eyes (11:00 in the morning), it really hurts. She closed her eyes because she couldn't leave it open. When she opens her eyes, she saw something like she's blind and was really concerned, the first time it started was Saturday, 15May2021. Yesterday and Sunday, it happened three times, today two times already. It was ongoing, persisting, and was happening more often. It's getting worse since yesterday. Patient already talked to the doctor in the hospital, but they gave her prescriptions because they said for the pain all over her body that it was the symptoms for the shot, so they gave her prescription for the muscle pain and they said it was gonna be gone like a couple of days, and it was still there for more than two weeks, so it was too much. Patient stated another thing that concerns her was she has lost her appetite. She still took her vitamins, but she didn't know what the pain was from. Patient confirmed all symptoms have gotten worse since they began. Patient then decided she would like to be transferred to facility because she has pain now and would like to speak to someone. Patient reported of right-sided back/neck/shoulder/arm pain that began after her first Pfizer COVID vaccine and worsened when she received her second dose. Patient stated the doctor sent her some medicine, like anti-inflammatory and muscle pain relievers, but it didn't help. No family medical history relevant to AEs. No relevant tests. AEs did not require a visit to emergency room and physician office, just talked to physician on the phone. Follow-up attempts are needed. Information about lot/batch number is available.
57 2021-06-01 seizure, muscle twitching, numbness Convulsions, twitching at 1:00am . Strong adrenalin rush. Got out of bed and worked, moved around ... Read more
Convulsions, twitching at 1:00am . Strong adrenalin rush. Got out of bed and worked, moved around rapidly. I've had mild twitching, muscle contractions, numb nerves in arms and hands ever since. It is mild though. Seems to come and go in waves, along with intense fatigue. June 1, 2021 first day I did not have intense fatigue. Just found out I was supposed to receive a CDC text or reaction monitoring form; I did not.
57 2021-06-02 feeling hot, cold sweat 09:07 10 minute after receiving the 2nd Pfizer vaccine, pt.c/o being hot and clammy. Pt. states she ... Read more
09:07 10 minute after receiving the 2nd Pfizer vaccine, pt.c/o being hot and clammy. Pt. states she had the same reaction after the 1st Pfizer vaccine. There was no syncope event, hr 71, O2 98%, and AAO. Cold pack applied to her head and water given. Pt. monitored for 30 min, feelings resolved. Pt. discharged from clinic and accompanied by her husband.
57 2021-06-02 nerve injury Pain from waist down so excruciating; Throwing up; Could not lay down/sleep; loss of mobility; Could... Read more
Pain from waist down so excruciating; Throwing up; Could not lay down/sleep; loss of mobility; Could not lay down/sleep; Could not stand up/walk; Completely disabled in lower extremities; Could not walk w/o holding on to chair/counter; Something else going on with nerves; This is a spontaneous report from a contactable consumer(patient). This 57-year old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0153) at single dose on 14Apr2021 13:00 via an unknown route in left arm for Covid-19 immunization. Medical history was "none". Patient was completely healthy, no known allergies. Patient did not have covid prior vaccination. No other vaccine in four weeks, prior to the COVID vaccine, no other medications in two weeks. Within 24 hours after Shot#1, patient could not walk without holding on to chair/counter. Within 48 hours, patient could not stand up/walk, pain from waist down so excruciating, patient began throwing up (lasted 3-4 days), could not lay down/sleep (for at least 3 weeks). Patient went to Emergency room, got x-rays, CT scans, blood workup, etc. All results normal. Patient experienced undetermined cause of loss of mobility. 5 weeks later, patient was still unable to stand up on own, pain unbearable. No pain pills provided, just ibuprofen, Chiro adjusted her 3 times/week since, ice every 1-2 hrs, but it only able to alleviate some of the pain. Patient also reported something else going on with nerves. Patient needed to see a Nerve specialist. She was completely healthy/running/walking on day of shot and next day forward, completely disabled in lower extremities. Patient reported that she knew Shot 1 had done something damaging to her nerves. Adverse event start date was reported as 15Apr202110:00 AM, which resulted in Doctor or other healthcare Professional office/clinic visit, Emergency room/department or urgent care. Other treatment information was unknown. Patient did not have covid tested post vaccination. The report was assessed as non-serious. Outcome of the events was not resolved.
57 2021-06-02 pain in extremity sore arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-preg... Read more
sore arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN 6206, expiration date not provided), 1st dose via an unspecified route of administration, administered in arm left on 05Mar2021 15:00 at age of 57 years old as a single dose for COVID-19 immunisation. Medical history included Hashimoto's Thyroiditis, migraine. Concomitant medications included levothyroxine sodium (SYNTHROID); liothyronine sodium (CYTOMEL); ethinylestradiol, norethisterone acetate (FEMHRT); meloxicam taken for Knee injury; magnesium. The patient previously took amoxycillin, celebrex, clindamycin and known allergies. The patient experienced sore arm on an unspecified date. After first dose, just a sore arm but patient was taking meloxicam for a knee injury and wondered if the anti-inflammatory tempered the reaction. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR): negative (nasal swab) on 15May2021. The outcome of the event was resolving. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The report was reported as non-serious by reporter.
57 2021-06-02 pain in extremity Cannot carry out my normal activities without feeling like I need to lie back down; Soft stools; Dia... Read more
Cannot carry out my normal activities without feeling like I need to lie back down; Soft stools; Diarrhea; Listless; Feeling worn out, listless, and uneasy 5 days after; Feeling worn out/Severely fatigued; Experienced GI issues; body aches; sore right arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 13:00 (Batch/Lot Number: ER87290) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included Allergies: Penicillin, Allergies: sulfa; (Allergies to medications, food, or other products: Penicillin, sulfa), breast cancer remission (Had breast cancer 3 years ago but am in remission). Age at vaccination: 57 Years. Patient was not pregnant: No. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Other. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Concomitant medication(s) included gabapentin taken for an unspecified indication, start and stop date were not reported; desvenlafaxine succinate (PRISTIQ) taken for an unspecified indication, start and stop date were not reported. List of any other medications the patient received within 2 weeks of vaccination: Gabapentin, Pristiq Reported. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Historical Vaccine included BNT162B2 for COVID-19 immunization (Start Date/Time: 24Mar2021 01:00 PM, Right arm, dose number: 1, Lot number: EP7534) (Age at vaccination: 57-year-old). The patient experienced soft stools (non-serious) on 14Apr2021 15:00, diarrhea (non-serious) on 14Apr2021 15:00, listless (non-serious) on 14Apr2021 15:00, feeling worn out, listless, and uneasy 5 days after (non-serious) on 14Apr2021 15:00, feeling worn out/severely fatigued (non-serious) on 14Apr2021 15:00, experienced GI issues (non-serious) on 14Apr2021, body aches (non-serious) on 14Apr2021, sore right arm (non-serious) on 14Apr2021, cannot carry out my normal activities without feeling like i need to lie back down (non-serious) on an unspecified date. Adverse event: Soft stools within 2 hours of vaccine, then Diarrhea for 1 day, then soft stools for 2 more days. Feeling worn out, listless, and uneasy 5 days after. Adverse event country: US. if patient recovered: Recovering. Was treatment received for the adverse event: No. Vaccine Facility information available. Ethnicity information is available. Race information is available. Does Pfizer have permission to contact your/the patient's healthcare provider about this report: Yes. Event: Experienced GI issues within a couple of hours following the 2nd vaccine on 14Apr2021; soft stools, then body aches and sore right arm the evening of the 2nd vaccine; Had diarrhoea the following day for 24 hours, then back to soft stools for a couple of days following that. Stools back to normal my 14Apr2021. Severely fatigued 15Apr2021, then felt a little less fatigued over the weekend. Then became extremely fatigued again on 20Apr2021 and continued on until today, 22Apr2021. Cannot carry out my normal activities without feeling like I need to lie back down. Have contacted my primary care physician and am waiting for a call back, but not sure what can be done. Have submitted a previous report of these symptoms as well. I also had blood work done 1 month prior to the 1st vaccine and all was good. This issue seems to be a direct effect from the vaccine itself. Would appreciate a call back to discuss due to the fact I do not see any of these types of long term adverse effects on your site. if patient recovered: Not recovered. For events, soft stools, outcome was recovered on unspecified date in 2021, Diarrhea, outcome was recovering, Listless, outcome was recovering, feeling worn out, listless, and uneasy 5 days after, outcome was recovering, feeling worn out/severely fatigued, outcome was not recovered, experienced GI issues, outcome was not recovered, body aches, outcome was not recovered, sore right arm, outcome was not recovered, cannot carry out my normal activities without feeling like i need to lie back down, outcome was not recovered. The patient underwent lab tests and procedures which included blood work: all was good in 2021. Information about Lot/Batch number is obtained. Additional information has been requested
57 2021-06-02 pain in extremity heart palpitation, shortness of breath (did not require hospitalization, pain on right side of chest... Read more
heart palpitation, shortness of breath (did not require hospitalization, pain on right side of chest and arm. Felt like I had to take a deep breath every 15 minutes for about five-seven days. Heart palpitations were mostly on 4/18/21
57 2021-06-02 pain in extremity 101.5F temp over night; significant pain in the injected arm; muscle aches; headache; This is a spon... Read more
101.5F temp over night; significant pain in the injected arm; muscle aches; headache; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), via an unspecified route of administration, administered in Arm Left on 06Mar2021 08:00 (age at vaccination 57-year-old) as 2nd dose, single for COVID-19 immunisation. Facility type for vaccination was other. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. Medical history included known allergies to Ivp dye, chronic sinusitis, high cholesterol. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for Covid post vaccination. Concomitant medications in two weeks included rosuvastatin (ROSUVASTATIN), ezetimibe (ZETIA) and Thorne multivitamin. On 06Mar2021 21:00, the patient experienced 101.5 f temperature overnight, significant pain in the injected arm, muscle aches, headache. The patient underwent lab tests and procedures which included body temperature: 101.5 Fahrenheit on 06Mar2021 101.5F temp overnight. The patient did not receive any treatment. The outcome of events was not recovered. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
57 2021-06-02 tingling, electric shock sensation, muscle twitching, tremor Initially, after the first shot, I felt fatigued. Ten days later, I woke to neck and face tremor wit... Read more
Initially, after the first shot, I felt fatigued. Ten days later, I woke to neck and face tremor with shaking in lip on 5/17/2021. Each night since I have have tingling and electrical sensations in neck, mainly on the left but have noticed it on my right a couple of times as well. I woke to a tremor sound in my left ear another night. Face sensations and lip shaking on two additional occasions and the other nights, a tingly, electrical current type tremor. These last only a short moment but it's scary. I have never had any health issues. I also have mild twitching at night in legs and arms. Maybe I am more sensitive and attuned now but I think that is also related to these other symptoms.
57 2021-06-02 tingling, sensory loss red rash wrist, itching, about a 3-4 inch area; red rash wrist, itching, about a 3-4 inch area; Jaw ... Read more
red rash wrist, itching, about a 3-4 inch area; red rash wrist, itching, about a 3-4 inch area; Jaw up to ear, under eye, eye lid, down her neck, left side of windpipe, back of neck, shoulder and left side of forehead lost sensation, lost sensation in part of arm above elbow.; tingling sensation in mouth, tingling lip; upper lip went numb; tingling half face; Headache; left arm swelled up; Elevated Heart Rate; Brain fog; dry mouth; funny sensation in her mouth; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0158, Expiration Date: 31Jul2021), via an unspecified date of administration in left arm on 14May2021 at 09:35 (at the age of 57-year-old) at first dose, single for COVID-19 immunization. The vaccine was administered at hospital. The patient did not receive other vaccine within four weeks prior to the first administration date of the COVID-19 vaccine. Relevant medical history included dental work to left upper molar done on 11May2021. She was given anesthesia and stated all this resolved. She had the procedure at 10:00. The patient was not receiving concomitant medications. On 14May2021 within 10 minutes of receiving shot the patient experienced tingling sensation in mouth, tingling lip, half face, and upper lip went numb. Her jaw up to ear, under eye, eye lid, down neck, left side of windpipe, back of neck, shoulder and left side of forehead lost sensation. Left arm swelled up and lost sensation in part of arm above elbow. The patient went to the emergency room for these symptoms and she was monitored there. The patient stated she is about 90% resolved of these symptoms, but they are not completely gone. On 14May2021 had headache that has resolved but she keeps having a sensation like she is about to get a headache on the left side of her forehead and also had elevated heart rate. She stated that her heart rate was elevated for many hours. It was still higher than normal for her when she left the emergency room. On 17May2021 had right red (rash), very itchy area on right wrist. Came on all of the sudden and was fire red and very itchy, was about a 3-4 inch area. Dissipated within an hour. She is still experiencing brain fog since an unspecified date in May2021, it is improving; but she had to take a half a day off of work the day before reporting to rest. Dry mouth and a funny sensation in her mouth are still lingering since an unspecified date in May2021. The patient stated that she called her doctor's office the day before and is awaiting a call back. She says the emergency room doctor told her to follow-up with her doctor and that the emergency room doctor also advised her not to get the second vaccine. They stated that she could potentially have a long-lasting vaccine effect. The patient asked what are the risks of her getting the second shot since she had such a severe reaction that is taking so long to resolve. Rash resolved on 17May2021, headache resolved on 14May2021, final outcome of heart rate increased was unknown, dry mouth and a funny sensation in her mouth had not resolved, while all the remaining events were resolving.
57 2021-06-03 cold sweat Body aches; CLAMMY; Joint aches; Chills; 100 degree Fever; This is a spontaneous report received fro... Read more
Body aches; CLAMMY; Joint aches; Chills; 100 degree Fever; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 17Mar2021 at 10:00 (at the age of 57-year-old), as a single dose for COVID-19 Immunisation. Medical history included high BP (blood pressure) and obese. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 13:00, the patient experienced 100-degree fever, chills, clammy, body and joint aches. No therapeutic measures were taken for the adverse events. The clinical outcome of the events 100-degree fever, chills, clammy, body aches and joint aches was recovering at the time of report. No further follow-up attempts are needed. No further information is expected.
57 2021-06-03 numbness, sensory loss, facial paralysis I woke up at 6 am with numbness in my left arm and hands, I went to work and it kept progressing, I ... Read more
I woke up at 6 am with numbness in my left arm and hands, I went to work and it kept progressing, I took Claritin, drove home and slept for 2 days, I was totally out of it, I only got up to go to the bathroom or drink something. I was good for 24 hours then I was so fatigued slept 2 more days, I woke on the 18th I was numb, I woke up drooling, my whole left side was numb I had some drooping in my face and my boob. I did a tele med visit that morning , My doctor started me on a prednisone pack, Lymph nodes and my breast for very tender on left side. I went to see neurologist bc symptoms were not getting better and I was extremely fatigued, which is not me, I also have sever hip pain, that I never have had before. The neurologist diagnosed me Sensory deficit disorder on the left side of my body.
57 2021-06-03 muscle spasms Debilitating leg cramps; Could barely walk; Could not sleep; This is a spontaneous report received f... Read more
Debilitating leg cramps; Could barely walk; Could not sleep; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old non pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot no: I 6198) via an unspecified route of administration in the left arm on 16Mar2021 at 08:30 hours (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included unspecified medications for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021 about 20:00 hours, the patient experienced debilitating leg cramps until 17Mar2021 12:00. On the same day, the patient could not sleep and could barely. The clinical outcome of the event debilitating leg cramps was recovered on 17Mar2021 12:00 and for the events could barely walk and could not sleep was reported as resolving. No follow-up attempts are needed. No further information is expected.
57 2021-06-03 pain in extremity first vax was arm soreness and about a week of fatigue; first vax was arm soreness and about a week ... Read more
first vax was arm soreness and about a week of fatigue; first vax was arm soreness and about a week of fatigue; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: er8730) via an unspecified route of administration (At the age of vaccination 57-year) in Left Arm on 25Mar2021 08:45 as 1st dose, single dose for COVID-19 immunization. Medical history included fibromyalgia, hypersensitivity Allergies to codeine, levaquin, cipro, sulfa, antibiotics, shrimp. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced first vax was arm soreness and about a week of fatigue. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 14May2021. The seriousness of the event was reported as non-serious. The clinical outcome of the event was not recovered. Follow-up attempts are needed. Further information is expected.
57 2021-06-03 pain in extremity IMy lower body was sore and I had a hard time getting out of bed. I could not put on my own shoes an... Read more
IMy lower body was sore and I had a hard time getting out of bed. I could not put on my own shoes and socks. My Flammatory numbers were very high. I submitted this information already but have not had any reply back. I went to a rhuematologist who said I now have Psoriatic Arthritis. I still have a hard time walking so she sent me to an Orthopedic Physican who said my bones are fine and the vaccine is affecting my cells. The only time I am able to function is when I am on steroids!
57 2021-06-03 cold extremities, feeling cold, weakness B cold feeling (like stepping on cold water or ice ) at the arch of the foot/cold feeling at the R d... Read more
B cold feeling (like stepping on cold water or ice ) at the arch of the foot/cold feeling at the R deltoid, R biceps and triceps, and R upper leg; B cold feeling (like stepping on cold water or ice ) at the arch of the foot/cold feeling at the R deltoid, R biceps and triceps, and R upper leg; Feeling less energetic but able to do ADL; This is a spontaneous report from a contactable other HCP (health care professional, who reported for herself). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: EN6203, expiration date unknown) 1st dose, via an unspecified route of administration administered in Arm Right on 28Feb2021 at 11:00 am, as single dose for covid-19 immunization. Medical history included B peripheral neuropathy post op (L5- S1), urinary retention postoperative, superficial melanoma (excision required, no treatments) and seasonal allergies. Concomitant medication included estrogens esterified, methyltestosterone (ESTRATEST); progesterone (PROMETRIUM [PROGESTERONE]); tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]); cyanocobalamin (B12 [CYANOCOBALAMIN]); collagen (COLLAGEN) and Biot. The patient previously took IV Infed on which experienced anaphylaxis) and IC Feraheme on which experienced hives. The patient had not received prior covid vaccination and had not tested covid post vaccination. The caller stated that after receiving the first dose of vaccine on 03Mar2021 she experienced B cold feeling (like stepping on cold water or ice) at the arch of the foot, cold feeling at the R deltoid, R biceps and triceps, and R upper leg and was feeling less energetic but able to do ADL. The patient had not received any treatment to treat the event. The outcome of the events was not recovered. No Follow-up attempts are possible. No further information is expected.
57 2021-06-04 pain in extremity small itchy rash on lower back approx 2 days after vax; 2nd vax heavy fatigue; arm pain for a week-1... Read more
small itchy rash on lower back approx 2 days after vax; 2nd vax heavy fatigue; arm pain for a week-1/2 and about the 4th week; having difficulty breathing/getting a full breath which has continued to this point; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0164), dose 2 via an unspecified route of administration, in the right arm on 16Apr2021 08:45 (at the age of 57 years old) as 2nd dose, single dose for COVID-19 immunization. The patient medical history included fibromyalgia and the patient was allergic to codeine, levaquin, cipro [ciprofloxacin], sulfa antibiotics, and Shrimp allergy. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, in the left arm on 25Mar2021 08:45 as 1st dose, single dose for COVID-19 immunization. On 11May2021, the patient experienced heavy fatigue, arm pain for a half week and about the 4th week, she had been having difficulty breathing/getting a full breath which was continued to this point. The patient reported that she can get full breath when leaning forward. This comes and goes throughout the day. It was also improved if she walks or workout but returns. The patient went to emergency room on 21May2021, workup came back negative for cardiac, looked good, lungs looked good. The patient reported that she saw pulmonologist -PFT on June 1st. The patient had small itchy rash on lower back approximately 2 days after vaccine and cleared up after a few days. Fatigue had lessened and breathing issues still at same level. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
57 2021-06-06 numbness, tingling Numbness and tingling in fourth and fifth fingers almost immediately after vaccine injection. This ... Read more
Numbness and tingling in fourth and fifth fingers almost immediately after vaccine injection. This resolved in about 30 minutes. A few days later I have sharp pain on range of motion in my left shoulder that continues to this day, pain in my left shoulder if I sleep on my left side.
57 2021-06-07 pain in extremity tried to raise her arm and could only raise it halfway and not all the way; sore arm; Sinus infectio... Read more
tried to raise her arm and could only raise it halfway and not all the way; sore arm; Sinus infection; This is a spontaneous reported from a contactable female nurse reported for herself. A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EW0172) via unspecified route of administration in left arm on 14May2021 for COVID-19 immunisation. The patient relevant medical history included sinus infections and had surgery for the same. Concomitant medications were not reported. On 16May2021, the patient experienced sore arm, tried to raise her arm and could only raise it halfway and not all the way and on an unspecified date in May2021, she experienced sinus infection. She stated the only problem she had after the vaccine since, she had no swelling, or no redness was just a sore arm for 4 or 5 days and that is all. Also stated that she did not feel anything and the person that did it was real easy, she stayed there for 30 minutes after and everything was fine and two days later it started little by little but it was not real severe and she did not have to take medication since it was just a mild thing. After 2 days started mild got a little worse but not bad enough where she had to medicate herself for it. Also stated she tried to raise her arm and could only raise it halfway and not all the way so she kept moving it so it would not get stiff. She did not have the sore arm before but it was very minor and lasted 4 or 5 days and when she tried to raise her arm it started becoming more sore and so she would move it slowly and she had no other symptoms like no numbness, no redness, and no swelling. She also reported that she is due for the second dose of vaccine on 04Jun2021 but will not be getting that since she had a sinus infection and was taking medication. It was reported that the sinus infection started more than 10 days, she went to the doctor and got antibiotics for it and went yesterday again to the doctor since it was not getting any better and the doctor changed her medication. She again had to visit her doctor Thursday and cleared from her doctor once all is well. The patient did not want to get the second dose yet so she knows what symptoms are related to the vaccine. As per her, the sinus infection is not related to the vaccine since she has gotten them for years and has even had sinus surgery. It is allergy season now and with the weather change and every time she runs the air conditioner she cannot tolerate it and ends up with a sinus infection. Sinus infection has improved but she still has to finish her medication, the medication that she was originally taking first did not help her get any better was Augmentin (the manufacturer, NDC number, lot number, or expiry date, product strength and count size dispensed was not available). No treatment was received for sore arm and arm and could only raise it halfway and not all the way. Seriousness of the events was reported as non-serious. Outcome of the events sore arm and tried to raise her arm and could only raise it halfway and not all the way was reported as recovered on an unspecified date in May2021 and the event sinus infection was recovering at the time of this report. As per reporter, the events sore arm, tried to raise her arm and could only raise it halfway and not all the way were considered as related however, the event sinus infection was considered as not related to the vaccine. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known disease pathophysiology, the event of sinusitis is assessed as not related to BNT162B2, and more likely due to history of sinus infections and surgery.
57 2021-06-07 pain in extremity allergies; itchiness on her head and her body; her skin felt tight; when she scratched her skin, her... Read more
allergies; itchiness on her head and her body; her skin felt tight; when she scratched her skin, her skin turned red, but the skin redness went away; when she scratched her skin, her skin turned red, but the skin redness went away; her left arm was very sore about an hour after she received the vaccine, and the whole remainder of the day; the COVID-19 Vaccine injection site had itched a little bit; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration administered in arm left on 12Mar2021 09:30 as 1st dose, single dose for COVID-19 immunization. Medical history included psoriasis , eczema ,hives ,seasonal allergy ,urticaria on an unspecified date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine within 4 weeks, prior vaccinations. Reported her second COVID-19 Vaccine was scheduled for 09Apr2021. The patient experienced allergies on an unspecified date, itchiness on her head and her body on and her skin felt tight, when she scratched her skin, her skin turned red, but the skin redness went away on 14Mar2021, her left arm was very sore about an hour after she received the vaccine, and the whole remainder of the day and the covid-19 vaccine injection site had itched a little bit on 12Mar2021. Therapeutic measures were taken as a result of allergies with Singular (Montelukast) 10mg tablet every morning (NDC Number: 13668-081-90, Lot Number: 4L716007 *stated it as "Batch Number", and Expiration Date: Dec2021), and either a Zyrtec 10mg tablet (NDC Number: 50580-726-70, Lot Number: 1776350, and Expiration Date: Apr2023), or a Xyzal (Levocetirizine) 5mg tablet every night. (She said the Xyzal was dispensed every 3 months in a pharmacy bottle, providing NDC Number: 68462-0346-90, and no Lot Number and Expiration Date) and for her left arm was very sore about an hour after she received the vaccine, and the whole remainder of the day with total of 2 Extra Strength Tylenol 500mg tablets (1 tablet each at 2 different times on 12Mar2021), or 1000mg total. The patient underwent lab tests and procedures which included retina eye check done a couple months ago: she said her eyes were dilated, and dye tested on an unspecified date. The vaccination facility type was reported as church. She said her doctor told her she didn't need to have a doctor's visit, and her itchiness was due to her allergies and she emailed her doctor through her patient portal. The outcome of the event allergies was reported as unknown, itchiness on her head and her body, her skin felt tight, when she scratched her skin, her skin turned red, but the skin redness went away was reported as recovering while her left arm was very sore about an hour after she received the vaccine, and the whole remainder of the day, the COVID-19 Vaccine injection site had itched a little bit and when she scratched her skin, her skin turned red, but the skin redness went away was reported as recovered on an unspecified date in Mar2021. Follow-up attempts are completed. No further information is expected.
57 2021-06-07 seizure 3 Violent seizures; 3 Violent seizures; body aches; chills; This is a spontaneous report from a cont... Read more
3 Violent seizures; 3 Violent seizures; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 15:00 at the age of 57-years-old (Batch/Lot Number: EW0161) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included chronic kidney disease, atrial septal defect, essential tremors in both hands, seizures, currently taking blood thinners, known allergies: Ampicillin, Penicillin, grapes, raisins. The patient previously took ampicillin and experienced allergy. The patient was not pregnant at time of Vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient experienced 3 violent seizures, body aches and chills on 30Apr2021 21:00. For 3 weeks non stop, she went to emergency room twice and was tested for COVID in one of those times at the ER, tested negative. Records of ER (Hospital name withheld) 03May2021 and 21May2021. There was no treatment received. The patient underwent lab tests and procedures which included Nasal Swab: negative on 21May2021. The outcome of the events was recovered with sequelae.
57 2021-06-08 burning sensation had swelling all the way up her arm and to her shoulder and to the shoulder blade and almost down to... Read more
had swelling all the way up her arm and to her shoulder and to the shoulder blade and almost down to the elbow; hematoma; hot and its feels like a line a fire into her palm where it was on the nerve; The second dose, the caller was down for about three days.; Second dose: extreme nausea ; Second dose: extreme headache ; Swelling at the injection site; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0178, Expiration date: unknown), via unspecified route, administered in left arm on 27May2021 (at the age of 57-year-old) as 2nd dose, single dose for COVID-19 immunisation. patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW976, Expiration date: unknown), via unspecified route, administered in right arm on 06May2021 (at the age of 57-year-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history includes ulcer. Concomitant medications were not reported. The patient historical vaccines include allergy shots and she experienced swelling as a reaction. The swelling happened after every allergy shot, she ever had, this was 20 years ago. The swelling would start about a day later. The caller would get one allergy shot on a Monday and then one shot on a Friday. The caller also explained he was diagnosed in the fall of 2020 and the caller cannot take Ibuprofen because of this. On 27May2021, after the vaccination, the patient experienced vaccination site swelling, had swelling all the way up her arm and to her shoulder and to the shoulder blade and almost down to the elbow. The swelling is very raised and hot and it felt like a line of fire into her palm where it was on the nerve. The caller thinks it's a hematoma now. The swelling is now the size of an egg in both shape and depth on 29May2021, patient experienced headache and nausea for 2 days. On an unspecified date patient also experienced feeling down for 3 days. The reporter assessed all events as non-serious. The caller explained he will not get the booster vaccine if Pfizer offers it. also explained that Swelling at the injection site has improved and now it is down to the hematoma the size of an egg. The hematoma is sitting on a nerve and the only thing the caller can do is ice it until it goes away. The outcome of the events mentioned as vaccination site swelling recovering. Nausea, headache and fatigue recovered on 31May2021 and the outcome of peripheral swelling and burning sensation was unknown. No follow-up attempts possible. No further information expected.
57 2021-06-08 numbness, pain in extremity Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat t... Read more
Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; felt sensation of lacking oxygen to brain similar to high altitude sickness; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; muscle aching in legs, hips and lower back; off balance; room spinning; Headache; throat swelling; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 57-year-old female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EW0151 and Expiration date was not provided), via an unspecified route of administration in Arm Left on 16Apr2021 08:30 (age at vaccination 57-year-old) as 1st dose, single dose for COVID-19 immunization. The patient was not pregnant. Medical history included spondylosis, hypothyroidism, diverticulitis, Allergies to medications, food, or other products penicillin, arithamyacin and tetracycline. Concomitant medications included tizanidine (TIZANIDINE); sulindac (SULINDAC); thyroid (ARMOUR THYROID). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The adverse event result in any of the following Emergency room/department or urgent care. On 16Apr2021 09:30, the patient experienced numbness in face from bridge of nose, across cheek bones, below chin. Numbness tingling tongue. throat tightening. muscle aches thighs of legs, worse on left leg. stumbling while walking. chills, sore arm, fatigue, confusion, felt sensation of lacking oxygen to brain similar to high altitude sickness, muscle aching in legs, hips and lower back, off, room spinning, headache, throat swelling. Therapeutic measures were taken with Intravenous Benadryl and Pepcid. The outcome of events was Recovered/Resolved with Sequel on an unspecified date in Apr2021. Follow-up attempts are needed. further information is expected.
57 2021-06-08 tingling, limb paralysis Patient states she experienced arm pain and tingling post vaccination that is still occurring 3 week... Read more
Patient states she experienced arm pain and tingling post vaccination that is still occurring 3 weeks later. Her primary physician suspects she has SIRVA and has scheduled an ultrasound to determine if it is an injury such as muscle tear or an allergic reaction.
57 2021-06-08 tingling increased blood pressure; pressure center sternum; tingly limbs; bottoms of feet felt slapped/burned... Read more
increased blood pressure; pressure center sternum; tingly limbs; bottoms of feet felt slapped/burned; pain behind r. knee; dehydration; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6201) via an unspecified route of administration on 17Feb2021 at 15:00 (age at vaccination 57-year-old) at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient's medical history was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL3302) on 27Jan2021 via an unspecified route of administration in right arm at single dose for covid-19 immunization. On 22Feb2021 at 14:00 patient experienced increased blood pressure, pressure centre sternum, tingly limbs, bottoms of feet felt slapped/burned, pain behind right knee and dehydration. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included computerised tomogram of abdomen and pelvis, electrocardiogram and ultrasound gallbladder (Right Upper Quadrant) RUQ. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 22Feb2021, computerised tomogram of abdomen and pelvis: unknown results, electrocardiogram: unknown results, sars-cov-2 test: negative on 01Mar2021, ultrasound Gallbladder right upper quadrant (RUQ): unknown result. The outcome of event was not recovered. No follow-up attempts are possible. No further information expected.
57 2021-06-09 feeling hot Pt showed up for second pfizer vaccine this morning, she was already very anxious about receiving va... Read more
Pt showed up for second pfizer vaccine this morning, she was already very anxious about receiving vaccine, she has a phobia of needles. I went out and spoke to her about the vaccine and administered. She immediately said she felt hot/dizzy and needed something cool. I gave her an ice pack and instructed her to do deep breathing exercises. We continued to talk and take her mind off the vaccine. She said she was feeling better and I told her I wanted her to wait to make sure she was okay. She continued with the ice pack and resting in the booth. After her time was up waiting I checked in with her and she said she felt much better and was going to head home and then said this happens all the time after receiving vaccines.
57 2021-06-09 mild one side paralysis Patient presented on 4/8 to Hospital for COVID pneumonia, transferred to another hospital on 4/21/2... Read more
Patient presented on 4/8 to Hospital for COVID pneumonia, transferred to another hospital on 4/21/2021. At Hospital, she was treated with convalescent plasma, course of remdesivir, and dexamethasone. She was requiring HFNC during day and BiPap overnight. She began to improve with decreasing O2 requirements on 4/15. On 4/17, she was found to have L-sided deficits and increasing hypoxia, which required emergent intubation. Dexamethasone was increased to 6 mg BID and she was started on Levaquin and Flagyl for aspiration penumonia, consolidated to ertapenem on 4/20. She had been on Eliquis prior to this, but this was discontinued after she developed the stroke sx on 4/17, switched to Lovenox. Initial head CT negative, but repeat head CT on 4/19 showed large R sided MCA territory infarct. She was placed on ASA. 4/21 head CT showed edema and mild midline shift. Neurology was consulted, who recommended hyperventilation, 3% saline, and elevating HOB > 30 degrees. She was then transferred to St. Mary's ICU on 4/21. At Hospital, patient was treated for aspiration pneumonia (cefepime 2g Q8H on 4/22-4/25, meropenem 2g once on 4/22, tobramycin 400mg daily on 4/22-4/23) and COVID. However, she had significant difficulty weaning from mechanical ventilation. Given her prolonged course and her right MCA CVA with significant deficits it was predicted that she would need long term ventilatory support therefore PEG and tracheostomy were placed on 4/29. She remained relatively stable until 5/2 AM when she suddenly developed massive subcutaneous emphysema and hypoxia. It was suspected that her tracheostomy had become dislodged. Patient was re-intubated orally with difficulty however there was no color change with EtCO2 and patient was in cardiac arrest. CPR was briefly performed however code status was clarified and patient was DNR. Trauma surgeon and intensivist were in agreement that any other interventions would be futile. Time of death was 0645 on 5/2/21.
57 2021-06-09 numbness c/o facial numbness and heart palpitation after taking the vaccine dose #2. Denies PMH, psych hx i... Read more
c/o facial numbness and heart palpitation after taking the vaccine dose #2. Denies PMH, psych hx includes bipolar with patient admitted noncompliant with medications. Allergies-NSAID, PCN, Ibuprofen and tomatoes. V/S BP 142/76, P 95, R 18, O2 Sat 98%. pt. appears very emotional and cries often. Advice pt. to follow up with psych dr. Pt. verbalized understanding. Pt. taken home by the sister in no distress with symptoms resolved.
57 2021-06-09 tingling, muscle twitching, pain in extremity, burning sensation loss of balance 4/11/21 dizziness / unsteady walking 4/11 lightheaded / near falling to ground 4/24 ... Read more
loss of balance 4/11/21 dizziness / unsteady walking 4/11 lightheaded / near falling to ground 4/24 vertigo 4/28 - ER and hospialized for 2 days (4/28-4/30) Increased blood pressure Increased hear rate blurred vision, trouble concentrating, brain fog, short term memory impacted nystagmus hearing loss inflamation of 7th and 8th nerves, face twitching itchy head, tinglingly pain / burning in feet, achy hands joints,
57 2021-06-10 weakness Weakness; chest pain; myalgia; very sleepy; This is a spontaneous report from a contactable consumer... Read more
Weakness; chest pain; myalgia; very sleepy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received bnt162b2 (Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in left arm on 09Mar2021 at 14:30 (at the age of 57 years old) as 1ST single dose for covid-19 immunization. The patient had known allergies and unspecified medical history. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. Concomitant medications in two weeks included unspecified drugs. The patient had no other vaccine in four weeks. The patient experienced weakness, chest pain, myalgia, and very sleepy on 09Mar2021 at 14:30. The patient underwent lab tests and procedures which included blood test with unknown results. Treatment for events included intravenous (IV) meds, crutches. The outcome of events was recovered with sequelae. No follow-up attempts are possible. No further information is expected.
57 2021-06-12 seizure Subdural hematoma chronic with bleed for 3 weeks since about March 12, then acute subdural hematoma... Read more
Subdural hematoma chronic with bleed for 3 weeks since about March 12, then acute subdural hematoma on April 2. Required EMS, had a seizure during transport, and required a craniotomy with evacuation on April 2 within hours of the second vaccine m.
57 2021-06-14 pain in extremity, tenderness Extreme soreness of arm, painful to touch, difficulty breathing because of chest pain, joint pain in... Read more
Extreme soreness of arm, painful to touch, difficulty breathing because of chest pain, joint pain in left shoulder joint
57 2021-06-15 numbness Facial numbness especially over the lips, spreading from chin to eyes sockets; This is a spontaneous... Read more
Facial numbness especially over the lips, spreading from chin to eyes sockets; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; formulation: solution for injection; expiration date: unknown), via an unspecified route of administration on left arm on 08Feb2021 at 19:00 (at the age of 57-years-old) at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had allergies to percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol] and experienced drug allergy (hypersensitivity). Concomitant medications in two weeks included loratadine (LORATADINE), thyroid (ARMOUR THYROID) both were taken for an unspecified indication and start and stop date were not reported. The patient previously received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Feb2021 at 06:00 The patient experienced facial numbness especially over the lips, spreading from chin to eyes sockets. The patient did not received treatment for the events. The outcome of the event was recovered on unspecified date. Information on the lot/batch number has been requested.
57 2021-06-15 muscle spasms Nausea, severe muscle pain and cramps, chills, joint pain, severe headache, lasted 2days, chiroprac... Read more
Nausea, severe muscle pain and cramps, chills, joint pain, severe headache, lasted 2days, chiropractor visit
57 2021-06-15 pain in extremity Chills; headache; dizziness; pain in the arm; nausea; This is a spontaneous report from a contactabl... Read more
Chills; headache; dizziness; pain in the arm; nausea; This is a spontaneous report from a contactable (patient, self-reported). A 57-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, she experienced chills, headache, dizziness, pain in the arm, and nausea. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
57 2021-06-16 weakness, pain in extremity, numbness She received her first dose of the Pfizer COVID vaccine about one month ago. Starting one day after,... Read more
She received her first dose of the Pfizer COVID vaccine about one month ago. Starting one day after, she has had intermittent new issues with her hands. She describes intermittent difficulty moving (extending) digits 4+5 in both hands and digit 3 on the left and digit 1 on the right. She has had some new numbness of the left hand digit 3. She has had worsening of her chronic Raynaud's. She has also had intermittent difficulty swallowing solids and her tongue felt weak. This lasted just about 1 week after the vaccine. Her chronic diplopia also worsened since the vaccine. She has had proximal weakness in the arms and legs.
57 2021-06-16 breast pain hemorrhagic cyst; Breast pain and tenderness began after 2nd shot; Breast pain and tenderness began ... Read more
hemorrhagic cyst; Breast pain and tenderness began after 2nd shot; Breast pain and tenderness began after 2nd shot; uterine tract infection; abdominal pain; swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (also reported as on 28Mar2021, pending confirm) (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 57 years old. Patient was not pregnant. Medical history included Colon surgery in 2017, followed by colon cancer chemotherapy in 2017- 2018, follow up CT scans performed every 6 months. CT scan on 04Apr2021 showed no observation of cyst on ovary. Historical vaccine included first dose of COVID 19 vaccine (Brand: Pfizer; Lot number: ER8733; Vaccine location: Left arm) on 28Mar2021 11:00 AM). Concomitant medications included cetirizine hcl (CETIRIZINE HCL) 10 mg taken for an unspecified indication, start and stop date were not reported. The patient experienced hemorrhagic cyst (medically significant), breast pain and tenderness began after 2nd shot, uterine tract infection, abdominal pain, swelling, all on 19May2021 with outcome of not recovered. The patient underwent lab tests which included CT scan: no observation of cyst on 04Apr2021, ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder, a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm on 25May2021. Adverse event reported as: Breast pain and tenderness began after 2nd shot and lasted approximately 30 days. On 19May2021 had symptoms of uterine tract infection, abdominal pain, swelling. On 25May2021, primary care doctor ordered an ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder and a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm, may represent a hemorrhagic cyst. Left ovary not visualized. Followup is planned with gynecology surgeon. AE resulted in: Doctor or other healthcaremprofessional office/clinic visit. The treatment received for events included: antibiotic to treat infection. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Additional information is requested.
57 2021-06-16 tingling, numbness and pain in extremities, numbness Peripheral polyneuropathy - numbing and tingling sensation of my hands and fingers
57 2021-06-17 numbness, migraine, pain in extremity Intense Migraines; pain on right side of body; tired; headache; sleep all day/wasn't sleeping good; ... Read more
Intense Migraines; pain on right side of body; tired; headache; sleep all day/wasn't sleeping good; it's hard for her to look back to the right side; her arm is getting painful on her shoulder/back and numb; her arm is getting painful on her shoulder/back and numb; her arm is getting painful on her shoulder/back and numb; pain came on more strong in back; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration in in arm left (injection) on 05Apr2021 at 18:30 (Batch/Lot Number: EW0158) as single dose for COVID-19 immunization in hospital.The patient medical history was none. Concomitant medications included vitamin D, zinc, ascorbic acid (VITAMIN C ACID) and ascorbic acid/ergocalciferol/nicotinamide/retinol palmitate/riboflavin/thiamine mononitrate (MULTIVITAMIN 6) from an unspecified date and ongoing (been taking them her whole life). Prior vaccination (within 4 weeks) was None. On 07Apr2021, the patient experienced tired, headache, sleep all day/wasn't sleeping good, it's hard for her to look back to the right side, her arm is getting painful on her shoulder/back and numb and pain came on more strong in back. On an unspecified date, the patient experienced painful, intense migraines and pain in right side of body. It was reported that when she had the first shot, she had such a painful, she feels tired in the beginning that day and a little headache that's all. She stated that she goes to sleep all day and the next day she feels painful and thought it is because she was not sleeping good, but she has not slept good her whole life. It was reported that pain is coming more often, more strong, it goes all the way, she does a little massage and she just takes a Tylenol because they told her she can not take any other medicine so she took Tylenol and she put hot/cold packs in her back and she put some cream maybe for something but it's getting worse. It's hard for her to look back to the right side and her arm is getting painful on her shoulder/back and numb so she just uses cream and that's when she called the doctor. Patient stated that she has pain all the way in her right side, not in the left side and it's only on the right side all the way to her neck, all the way down into her back and then goes to her shoulder then goes all the way to her arm on the right side. There is nothing painful in her left side at all. She further wanted to know what happened because she has never felt that before. After that, she was really scared to get the second shot, but her boss and son told her she has to get it, maybe it will make her better, but it's making her worse. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in in arm left (injection) on 12May2021 at 18:30 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. It was reported that the side effects are getting worse after receiving second dose. The reason she got it is just to protect herself, she lives with her son and sister, she doesn't want them getting sick. Patient states she's a personal assistant for a wife and husband and she is 75 and he is 78 so she doesn't want anybody getting sick, not even herself, and she wants to protect others and she has seen parents and other family who have died from COVID and she doesn't want that to happen to any part of her family and any other people around her and that's the reason why. She states from the beginning, she told her son she didn't want to get the shot, her son told her she needed to get it to protect her. It was reported that AE of right-sided back/neck/shoulder/arm pain that began after her first Pfizer Covid vaccine and worsened when she received her second dose. Her doctor sent her some medicine, like anti-inflammatory and muscle pain relievers, but it doesn't help. She confirmed it was muscle relaxers that she received from the doctor. Her doctor prescribed two medicines, but she only chose to get the muscle relaxer because she couldn't afford to get the other. Caller unsure of LOT, NDC, or expiry date, or product name due to her not having the product with her at the time of call. Outcome of the events tired, headache, sleep all day/wasn't sleeping good, it's hard for her to look back to the right side, her arm is getting painful on her shoulder/back and numb and pain came on more strong in back was not recovered and painful, intense migraines and pain in right side of body was unknown. Follow-up attempts are needed. Information about lot/batch number is available.
57 2021-06-17 nerve pain I started to have pain and skin sensitivity along sciatic nerve on my left side on 4/12, 10 days aft... Read more
I started to have pain and skin sensitivity along sciatic nerve on my left side on 4/12, 10 days after receiving first COVID vaccine. 3 days later a rash started to develop in the same area. The rash continued to spread along back of left leg onto bottom of my left foot over the next week, accompanied by pain, sensitivity and itchiness. All symptoms subsided and resolved within about 6 weeks from onset.
57 2021-06-17 pain in extremity, seizure Seizures, shortness of breath, chills, body aches, chest pains due to the shot it strained the heart... Read more
Seizures, shortness of breath, chills, body aches, chest pains due to the shot it strained the heart muscle. Chest pain, briings out severe jaw pains, and very strong pain that radiated up and down left arm. All these symptoms have been going on since the beginning of Mary 2021 to the present time now. I can no longer, cook for myself, or do grocery shopping. My left arm is immoblle after shot was given causing me more heart issues. I have ask my doctor to put me on Disablity because I live alone and if I died no one would find my body until a month from now.
57 2021-06-17 pain in extremity, tremor I started getting chills with uncontrollable shaking 8 hours later; I started getting chills with un... Read more
I started getting chills with uncontrollable shaking 8 hours later; I started getting chills with uncontrollable shaking 8 hours later; and had a fever 3 degrees more than normal; I was extremely fatigued; started feeling unwell; it progressed to extreme stomach pain; extreme arm pain (in the arm that didn't get the shot); This is a spontaneous report from a contactable consumer (Patient). A 57-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 11:30 AM (at the age of 57-years-old) as a single dose for covid-19 immunisation. Medical history included obesity. Concomitant medications included calcium, colecalciferol (CALCIUM +VIT D) and Multi-vitamin taken for an unspecified indication both received two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient previously received Erythromycin and was allergic to it. Patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 24Jan2021 at 11:15 AM as a single dose for covid-19 immunisation. On 18Feb2021 at 06:30 PM, 31 hours after receiving the vaccine, patient started feeling unwell and it progressed to extreme stomach pain, and extreme arm pain (in the arm that did not get the shot). On 19Feb2021 at 02:30, she started getting chills with uncontrollable shaking 8 hours later and had a fever 3 degrees more than normal. The fever reduced 1 degree the following day, and 1 degree more the day after. The entire time she was extremely fatigued. By day 6, she felt fine. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered on an unspecified date. Follow-up attempts completed. No further information expected.
57 2021-06-18 cold sweat, muscle spasms I passed out in the bathroom; pulled the muscles in her back; This lead to uncontrollable muscle spa... Read more
I passed out in the bathroom; pulled the muscles in her back; This lead to uncontrollable muscle spasms in my back; dizziness; nausea/felt like I was going to throw up; I broke out into an all over clammy sweat and felt like I was going to throw up; body aches head to toe; low grade fever; This is a spontaneous report from a contactable other hcp (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Jun2021 10:00 (Lot Number: EWO183) at the age of 57-year-old as single dose for covid-19 immunisation. The patient was not pregnant. Known allergies included erythromyicine. Concomitant medication included fluoxetine (reported as floxitine) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2(lot number: EWD176) on 10May2021 05:00 PM at the age of 57-year-old, at arm left for covid-19 immunisation. On 01Jun2021, the patient experienced body aches head to toe, low grade fever. On 02Jun2021 08:00 AM, dizziness which lead to nausea which lead to a need to sit down immediately to avoid falling to the ground. Upon sitting, the patient broke out into an all over clammy sweat and felt like she was going to throw up. On the third time of getting up(03Jun2021), about 20 minutes after the first dizzy episode, she had to use the restroom. She passed out in the bathroom, woke up wedged between the toilet and the wall. The patient had no idea how long she was passed out. When she moved out of that position to stand up, she pulled the muscles in her back. This led to uncontrollable muscle spasms in her back. That morning (03Jun2021) Advice nurse directed her to the Urgent care due to passing out. She compromised with her doctor for lab work: blood and Urine, and EKG and muscle relaxer medication. 3 hours later, arriving home at 3:30 she took the medications and went to sleep. The muscle relaxer significantly reduced her pain. The adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse events included pain medications and lab results all showed normal levels. The patient had no covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the event pass out cannot be excluded completely. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-06-18 pain in extremity This is a spontaneous report from a contactable consumer or other non-health care professional (pati... Read more
This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: EW0173), via an unspecified route of administration, administered in arm left on 12Jun2021 10:00 (at the age of 57-year-old) as single dose, for COVID-19 immunization. The medical history included ongoing low blood platelet (this was diagnosed 3 years ago, at least). The patient's concomitant medications were not reported. The patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and did not receive additional vaccines administered on same date of the Pfizer vaccine. The patient stated that she saw something on the information the caller was given after receiving the first dose Pfizer Covid Vaccine about if the patient was on a blood thinner or had a blood disorder and she reported low blood platelets. On 13Jun2021, the patient didn't really have any problems besides a sore arm (next day after receiving the first dose Pfizer COVID-19 Vaccine) and got really sick. On 14Jun2021, the patient began to have nausea around midnight today, which was awful but the nausea was kind of improving and still had the nausea; the patient had vomiting began around midnight on the same day, it had been few hours since vomited and patient did not feel very good but it had improved; had vomiting began around midnight and had been a few hours since the patient vomited and she did not feel very good; the patient stated that everything came on at once between midnight and she was referring to chills which was not all the time, just got the chills and goose bumps and the chills have improved, bad headache which she had not felt this way, dizziness which was off and persisting, and muscle pain and thought that it was just stiff neck but it was all over and the muscle pain was the same; the glands under the ears are swollen and really hurt and patient stated that it started later after everything else started, which was right under the ears. The patient stated that patient went to bed fine and woke up just sick (got really sick last night). The patient stayed in bed most of the time. The caller states the glands under the ears being swollen and hurting is persisting. The patient mentioned that the headache got better for a little bit and then came right back. Therapeutic measures were taken as a result of bad headache with one rapid release Tylenol. The description of Product Complaint included: Description of complaint: The caller reported a bad headache after receiving the first dose Pfizer COVID-19 Vaccine. The caller took one rapid release Tylenol. The headache got better for a little bit and then came right back. The caller also stated she did not had her glasses on and was trying to find the information requested on the bottle. The caller asked her husband for assistance finding the information on the medication bottle. Product was Equate extra strength Acetaminophen 500mg; Lot: P123338; Expiration: Dec 2023; Product strength and count size dispensed: 500mg, 225 gel caps count size; and the sample of the product was available to be returned, if requested. The reporter was informed she may possibly receive a mailer in 3-10 business days and the packaging was sealed and intact. The patient taking Pfizer Covid Vaccine to get vaccinated against COVID-19. The patient was unable to provide address, telephone number or email and informed that she had not been to the doctor in a while. Further added that, the patient stated that she had one more dose of the Pfizer COVID-19 Vaccine to take in three weeks. The outcome of the event pain in arm, nausea, vomiting, chills was resolving; the outcome of the event got really sick, glands swollen, dizziness, muscle pain was not resolved; while the outcome of the event bad headache, goosebumps, localized pain, and neck stiff was unknown. Information on Lot/Batch number was available. Additional information has been requested.
57 2021-06-19 pain in extremity Rigors Total body joint aches chills fever headache arm pain
57 2021-06-20 involuntary muscle movements At 3:20PM, I looked up to see I only had 5 minutes left to leave and my heart started racing and I b... Read more
At 3:20PM, I looked up to see I only had 5 minutes left to leave and my heart started racing and I began to panic. My lips felt funny, my vision was a little weird. The nurse was called over and advised me I wasn't have an allergic reaction. She didn't want my heart rate to increase so she did not give me epinephrine. I drank water and sat for an additional 20 minutes by that time I had already consumed at least 60 ounces of water. I left the site feeling fine and began to notice my heart rate increasing again and my face and lips felt funny I couldn't make my mouth work when I attempted to drink water. I began to panic and went to the ER. They did bloodwork a chest x-ray an EKG gave me a bag of fluid through the IV and advised me I was fine and I was released.
57 2021-06-20 mild one side paralysis The pain in the shot area never left the upper arm, left arm suffering a stiffness and weakness fro... Read more
The pain in the shot area never left the upper arm, left arm suffering a stiffness and weakness from heart muscle being weakened by COVID Shot, I am unable to care for myself any longer and do things on my own because of left side of torso and arm being disabled.
57 2021-06-22 flushing Immediately after receiving I began itching first face, neck, head, eyes followed by whole entire bo... Read more
Immediately after receiving I began itching first face, neck, head, eyes followed by whole entire body itching along with my heart rate increased and flushing then hives started all over my entire body about 1/2-45 minutes after receiving then by 1 -2 hours after receiving I developed blisters in my scalp followed by my abdomen, back, arms, toes. The hives, itching and blisters lasted about 5 days. I was given Benadryl 25mg right away and then given another 25 mg about 15 minutes later by the Pharmacist who administered the vaccine. I was told to take another 50 mg of Benadryl in 1 hour and if I get worse to call 911 and go to the hospital immediately. I had to keep taking Benadryl for the next 4 days around the clock.
57 2021-06-22 numbness, tingling Within ten (10) minutes of receiving second Covid-19 Pfizer vaccine, my left arm and hand went numb ... Read more
Within ten (10) minutes of receiving second Covid-19 Pfizer vaccine, my left arm and hand went numb and tingly. An attending nurse completed various tests ruling out emergency treatment at that time, indicating I should see advice from my Primary Care Physician if side affects persisted the next day. The following day, the numbing/tingling expanded from the top of my head, all the way down the left side of my face, neck, arm, hand, lower leg and foot. I was seen by my Primary Care Physician who directed me immediately to the Emergency Room of Medical Center, as he thought I could be having a stroke or have a blood clot due to the affects of the Covid-19 Pfizer vaccine. With my symptoms continuing and worsening and blood pressure extremely high, I had blood drawn, was given an EKG and a CT Scan in the ER. A neurologist was also consulted who indicated my symptoms heard of after the vaccine but never seen in person. I was referred by the attending ER Physician, Dr., to follow up with the neurologist, Dr., and was given an appointment for Friday, April 23. 2021. I was evaluated, then scheduled and received a brain MRI with and without contrast on Wednesday, April 28, 2021. Tests given at the time in the ER and with the neurologist appeared to show no signs of a stroke, lesions, masses or a heart attack. The numbing/tingling continued with my left arm, leg and foot continuously for two weeks and moved around to other parts of my body for shorter periods of time during the duration. After the two weeks, the numbing/tingling sensation appears and disappears quickly (within 30 seconds) in my left arm/hand and left foot. This does not occur every day but still happens very sporadically. Note: The numbing/tingling sensation I felt within my head/face/neck area was consistent with the feeling of receiving novocaine. Please Note: Approximately 30 minutes after my first Covid-19 Pfizer vaccine, I experienced a numb/tingling in my tongue with slight discomfort and the sensation I had eaten something very acidic. I experience the same sensation at times after eating tomatoes or oranges. I could feel my uvula when swallowing and drank a tremendous amount of water. My throat did not close, nor did I have difficulty breathing. I took a Benadryl tablet before bedtime, and the sensation was gone the next morning. I mentioned this affect before receiving my second dose of the Covid-19 Pfizer vaccine. The nurse checked with others, and it was decided I would be kept for 30 minutes for observation instead of the usual 15 minutes following the vaccine.
57 2021-06-22 pain in extremity Low grade fever, body aches, stabbing pain from shoulder to elbow and tingled down to fingers. she i... Read more
Low grade fever, body aches, stabbing pain from shoulder to elbow and tingled down to fingers. she is now unable to lift her left arm over her head. She is unable to extend or lift her left arm. She really can not use her left arm without excruciating pain . The pain is from the arm and site where the injection was.
57 2021-06-23 burning sensation, discomfort Two days after first Phyzer shot, I awoke to what felt like my entire right leg feeling electrocuted... Read more
Two days after first Phyzer shot, I awoke to what felt like my entire right leg feeling electrocuted. It only lasted maybe 20 seconds and then it went completely away That evening I noticed that I was starting to get swollen in my legs and by Thursday evening it had become much worse and for the next few days I needed to use Hydrocholorthiazide to start reducing the sudden and very uncomfortable swelling, which did work. During that time my oximeter was flashing with oxygen levels below ninety and my heart rate was flashing into the low forties. I was out of breathe, even while I was lying down. My blood pressure was also dropping. Eventful I went to the hospital on 04/16/21. My heart was always racing and all of the other sudden symptoms, after realizing that all of this was happening after my first Phyzer shot on 04/06.. I was admitted into the hospital on 04/16 and I was discharged the evening of 04/18/21. All of those side effects went away.
57 2021-06-24 weakness Horrid smells since March 2021. Recurrent headaches. Coughing spells. Weak spells. Irritability. Swe... Read more
Horrid smells since March 2021. Recurrent headaches. Coughing spells. Weak spells. Irritability. Sweating. Chills. Rash. Spontaneous and various times every day.
57 2021-06-24 pain in extremity Sore arm where injectionwas given.; Itching in the injection sight; Itching in neck, cheststomach ba... Read more
Sore arm where injectionwas given.; Itching in the injection sight; Itching in neck, cheststomach back and other partsof the body.; Red blotches in the core areas.; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in left arm on 13Mar2021 at 07:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included sinus issues with sinus surgery in 2004, glute or hamstring surgeries in Oct2020. It was reported that the patient was an extremely active slim person and the glute or hamstring surgeries were healed for the most part. In Nov2020, the patient had COVID-19. The patient was tested positive for COVID-19 antibodies in Dec2020. Patient used to get the reaction at times when she gets a virus or bacterial infection for a day. Concomitant medications included diclofenac sodium (MANUFACTURER UNKNOWN), SUDAFED and supplements on unknown dates and for unknown indications. Prior to the vaccination the patient had not tested positive for COVID-19 and since the vaccination, the patient had not been tested positive for COVID-19. It is unknown if patient has allergies to food, medications or other products. On 14Mar2021, one day after vaccination, at 15:00, the patient experienced sore arm where injection was given, itching occurred in many different places such as the injection sight, neck, chest stomach back and at times other parts of the body. The patient also experienced red blotches in the core areas. The patient did not receive any treatment for the events.The clinical outcome of sore arm where injection was given, itching at the injection sight, itching on neck, chest stomach back and at times other parts of the body and red blotches were not recovered. No follow-up attempts are needed. No further information is expected.
57 2021-06-24 pain in extremity Chills 8 hours after shot; Arm soreness; This is a spontaneous report received from a contactable co... Read more
Chills 8 hours after shot; Arm soreness; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lopreeza (MANUFACTURER UNKNOWN) 0.5 mg and melatonin (MANUFACTURER UNKNOWN) 1mg on an unknown date for unknown indication. On 19Mar2021 at 00:00, the patient experienced chills 8 hours after shot and arm soreness. The patient did not receive treatment for the reported events. The clinical outcome of the events chills and arm soreness were recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
57 2021-06-25 tingling Shingles rash - Upper left shoulder - Treatment: Valacyclovir 1 gram tablet 3 times per day, 21 tabl... Read more
Shingles rash - Upper left shoulder - Treatment: Valacyclovir 1 gram tablet 3 times per day, 21 tablets. Treatment not complete. Rash still present, rash not spreading. Day of shot 6/15/2021 - slight tingling top of left hand, left foot, left side of face. Resided after 8 hours. 6/17/2021 to current (6/26/2021) - sneezing 6/18/2021 to current (6/26/2021) - mild chest congestion, wet cough, nasal inflammation (basically means, can't breath through nose), sinus congestion and drainage. Treatment: 10 mg Loratadine, over-the-counter cough and expectorant syrup, over-the-counter nasal spray.)
57 2021-06-27 weakness burning eyes,loss of vision, anxiety, confusion, weakness
57 2021-06-28 pain in extremity Frequent pain (nerve related) in the right leg, especially when not moving (lying in bed, etc).
57 2021-06-28 pain in extremity 3/10/2021 right knee swollen and extremely painful. This was first call to dr. Ok after few days... Read more
3/10/2021 right knee swollen and extremely painful. This was first call to dr. Ok after few days. Then, 3/10 knee, 3/23 hip, 4/2 right pointer finger swollen extreme pain, 4/4 neck limited range of motion.4/8 -4/14 left shoulder. 4/16 start 800 mg ibuprofen. 4/16 red patch back of hand. 4/20 right shoulder pain unable to hold steering wheel. No range of motion. Start one week prednisone . Sent to Rheumotologist. Start with 40 mg. 4/23 right foot toes swollen and ache. 5/1 swollen left ring finger but no pain. 5/2 swollen right ankle no pain. 5/2 swollen left hand fingers and red patch extreme pain and no sleep.800 mg ibuprofen and etodolac no help. 5/16 left hand again swollen extreme pain. 5/22 left hand. 5/25 right hand. 5/27 shoulder,. 6/4 feet.
57 2021-06-29 weakness Tiredness; did not have the usual energy level to do normal activities.; This is a spontaneous repor... Read more
Tiredness; did not have the usual energy level to do normal activities.; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 18Mar2021 at 13.45, (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not have allergies to medications, food, or other products. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 24Feb2021 at 13.30, (at the age of 57-years old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced tiredness and did not have the usual energy level to do her normal activities on 19Mar2021 at 10.00. The patient did not receive any treatment for the reported events. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tiredness and did not have the usual energy level to do normal activities was resolved on an unknown date in Mar2021. No follow up attempts are possible. No further information is expected.
57 2021-06-29 feeling hot she has a rash, rash on right cheek and rash on forehead; Stated that she has a rash that is quite r... Read more
she has a rash, rash on right cheek and rash on forehead; Stated that she has a rash that is quite red; Is kind of warm to the touch; like if she had a strep infection; This is a spontaneous report from a contactable consumer (patient). This consumer reported for herself that a 57-years-old female patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0167), (at the age of 57-years-old) via an unspecified route of administration on left arm on 02May2021 as single dose for COVID-19 immunisation. The patient's medical history includes fibromyalgia for 25 years which was still ongoing. Was not on medication anymore. Those medications gave her problems and made it worse. Concomitant medications were Modafinil (generic version of Provigil) has been taking for 10 years, at least for narcolepsy and Claritin (Clarithromycin) took daily during the spring and fall. Has taken for years but, only in those periods of time with seasonal allergies. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration on left upper arm on 04Apr2021 10:15 as historical vaccine single dose for COVID-19 immunisation. On 04May2021, the patient had a reaction to the second dose of the Pfizer Covid-19 vaccine which she administered on Sunday. She has a rash that was quite red where it bends, it was warm to the touch, but nothing was raised, looks like a sunburn, it was inside of her left arm on the elbow area, which was the same side as the injection. Her right cheek was red, as if she was slapped, she also has it across her forehead and in the back of her neck. She would like advice on how to treat it. Rash on inside of left arm: Noticed when she woke up this morning. Rash on right cheek: Developed soon after the rash on the arm. Was maybe an hour or so, when the cheek became red. Rash on forehead: Not as bad but looks very similar to the rash on her arm. Is getting more intense now. Is also on her neck. States that she got up around 06:30. It was a very similar rash to viral rashes. The last time she had it was probably when she had the flu. It was not during the pandemic. It was around Feb 2019. No prior vaccinations within 4 weeks. There were no relevant tests proceed. The outcome of the event was not recovered. Follow-up (04May2021): This is a follow-up spontaneous report from a contactable consumer (patient). This 57-years-old female consumer reported for herself. Follow-up attempts are completed. No further information is expected.
57 2021-06-29 pain in extremity metalic taste; throat tightened up; tachycardia 130-140 x 20 min; dizzyness; fatigue; headache; sore... Read more
metalic taste; throat tightened up; tachycardia 130-140 x 20 min; dizzyness; fatigue; headache; sore arm; This is a spontaneous report from a contactable consumer(patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID 19 Vaccine, Solution for injection, Lot number: EL1283, Expiration date: Not reported), intramuscular administered in arm right on 07Jan2021 12:00 (at a age of 57-year-old) as dose 2 single and recevied BNT162B2 (PFIZER-BIONTECH COVID 19 VaccineLot number: EH9899, Expiration date: Not reported) intramuscular administered in arm right on 07Dec2020 19:00 as dose 1 singel, for COVID-19 immunisation. Patient previously took the medication included were Loratab, Losartan, Amlodipine. Once received loratab patient become itchy, feels like bugs crawling all over. No significant relevant family history, No there predisposing factors, no was a culture performed. Concomitant medication included paracetamol (TYLENOL, Strength: 160 mg) at 160 mg taken from 07Jan2021 11:00; diphenhydramine hydrochloride (BENADRYL, Strength: 50mg) at 50mg from 07Jan2021 11:00. It was reported that the on 07Jan2021 at 12.00 patient experienced metallic taste, throat tightened up, tachycardia (130-140 within 20 min), dizziness, fatigue. Epipen was available at the time of 2nd injection did not need it. This all happened with in 1st 1 min of receiving the vaccine. No nausea or loose stools did have headache and sore arm lasted 2 days. No treatment needed. The events were considered as non serious. The outcome of the events were recovered, headache and sore arm were recovered on 09Jan2021.
57 2021-06-29 pain in extremity unable to use my arm as it is still swollen; unable to use my arm as it is still swollen and painful... Read more
unable to use my arm as it is still swollen; unable to use my arm as it is still swollen and painful; This is a spontaneous report from a contactable consumer (patient). This 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 03Apr2021 at 12:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included suspected COVID-19 in Jan2021; the patient stated she probably had COVID at New Year but was not tested and she spent a few days in bed and was exhausted for all of Jan2021. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received some antibiotics from unknown dates for unknown indications and experienced allergies; the second dose of shingles vaccine on 09Feb2021 in the left arm (at 57-years-old) for immunisation and experienced a bad reaction; and the first dose of BNT162B2 (lot number unknown) in the right arm on 13Mar2021 at 12:15 (at 57-years-old) for COVID-19 immunisation and experienced very painful and swelled up. The patient reported that since getting the second shot in her left arm on 03Apr2021 she had been unable to use her arm as it was still swollen and painful. Her doctor put her on a week of steroids, anti-inflammatory medications and muscle relaxers to try and reduce the swelling. The patient reported having had a shingles shot in that arm in early Feb2021 with a bad reaction that went away after a week; which was why she had the first shot of BNT162B2 in her right arm , which swelled up immediately and was very painful but started feeling better the next day. The events were reported as non-serious and did not require hospitalization; the event resulted in a physician office visit. The clinical outcomes of unable to use her arm as it was still swollen and painful were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
57 2021-06-29 tremor, cold extremities, muscle twitching Sweating; muscle twitches; overall shaking; cold hands and feet; nausea; no appetite; This is a spon... Read more
Sweating; muscle twitches; overall shaking; cold hands and feet; nausea; no appetite; This is a spontaneous report from a contactable other health care professional (patient). A 57-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in right arm on 05Feb2021 at 09:30 (at the age of 57-year-old) as a single dose for COVID-19 immunization at doctor's office/urgent care. The patient medical history included high blood pressure and had no known allergies. The patient did not receive any other vaccine within four weeks. Concomitant medications included metoprolol succinate at a dose of 50 mg/day and ascorbic acid (VITAMIN C) at a dose of 1000 mg, for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Feb2021 at 11:30, the patient experienced sweating, muscle twitches and overall shaking, cold hands and feet, nausea and no appetite, which resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date in 2021. Follow-up attempts completed. No further information expected.
57 2021-06-30 burning sensation 1st dose of the Pzifer vaccine was administer 5/16/21 in the left arm. Since then I still have pain... Read more
1st dose of the Pzifer vaccine was administer 5/16/21 in the left arm. Since then I still have pain in the site of the vaccine. I might think that the reaction is more to how the vaccine as administer that the vaccine itself. Despite applying ice for many weeks, I still experience discomfort at the site of the vaccine and minor burning.
57 2021-06-30 migraine 1. Severe headache. I developed a severe headache the next day that was a migraine but more resistan... Read more
1. Severe headache. I developed a severe headache the next day that was a migraine but more resistant than typical. It was severe and limited activity completely--put me to bed. It eventually responded to treatment but returned once the medication wore off for a total duration of about 3 days. I have chronic migraine and the severity and frequency of migraine substantially increased and remained increased after this vaccine, despite treatment adjustments by my neurologist, for about 2.5 months. Afer 2.5 months there was improvement in migraine, however not yet to baseline before the vaccines. I also had a severe headache for 1 day after the 1st dose in the series on 3-18-21 and some lesser increase in my migraine disorder, but only for about 2 weeks and then seemed to settle down a week before the 2nd dose. My ability to work is still limited because of this. I have limitations in work re-existing due to migraine that are worse since the vaccine. 2. Axillary swelling. The day after this vaccine, I noticed swelling and pain in my R axilla. It got worse over time. After about 3 days the pain subsided but the swelling persisted for about 10 days. At the worst, perhaps 3 days post-vaccine, I felt like I had a foam ball in my axilla when I had my arm resting against my body. I did not feel specific adenopathy or lumps. Just very soft swelling, filling the entire axilla. I am reporting as myself but am an MD After the 1st dose I noted swelling in R axilla incidentally in the shower 1 week after vaccine. It was gone in a couple days and there way no pain at any time.. I also had fatigue, marked, starting several hours after each dose and lasting through the next day. I had chills and body aches the day after the 2nd dose, but not the first. However, I was not febrile. Other than the migraine, my other side effects appear to have resolved.
57 2021-07-01 cold sweat, flushing, speech disorder Chest tightness; Wheezing; Cold sweat; Flushed; High BP; Difficulty speaking; This is a spontaneous ... Read more
Chest tightness; Wheezing; Cold sweat; Flushed; High BP; Difficulty speaking; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration in left arm on 21Mar2021 at 18:00 (age at the time of vaccination was 57-year-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks of COVID-19 vaccination. The patient did not experience COVID prior vaccination. The patient did not test for COVID-19 post vaccination. The patient's medical history included asthma, allergies, prior anaphylaxis to allergy shots, beta-thalassemia trait, sulfites allergy, pollens and molds allergy. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for an unspecified indication, start and stop date were not reported; bupropion (BUPROPION) taken for an unspecified indication, start and stop date were not reported; azelastine; fluticasone (AZELASTINE; FLUTICASONE) taken for an unspecified indication, start and stop date were not reported. On 21Mar2021 at 18:15, the patient experienced wheezing, cold sweat, flushed, high BP, difficulty speaking, chest tightness. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received epinephrine, albuterol, benadryl, solumedrol IV as treatment medication for the events. The outcome of the events was resolving. Follow-up attempts are possible. Further information is expected.
57 2021-07-01 discomfort began to have intestinal distress which has worsened each day since. Severe diarrhea has developed,... Read more
began to have intestinal distress which has worsened each day since. Severe diarrhea has developed, along with constant discomfort. The vaccine is really the only thing different in my life.
57 2021-07-01 feeling of insects crawling on skin, pain in extremity About 30 minutes after the vaccination, I started to feel dizzy, light headed, and my bottom lip s... Read more
About 30 minutes after the vaccination, I started to feel dizzy, light headed, and my bottom lip started to tingle and my mouth begin to water. I also started to notice thickening and drainage in the back of my throat. I took a Claritin. When I got home, I was still feeling dizzy and feeling tingling on my bottom lip. The next day, I was still feeling fatigue and tingling in lips and took another Claritin. A fews days later at work, I went to work and I was feeling light headed. My BP was low and my heart rate was high and feeling dizzy. I also starting having chest pains and pains in my arm and I felt like my skin was crawling. I called 911. At the ER, they did blood work, EKG, and cardiac enzymes. The blood work came back low in potassium and gave me potassium. All the other tests came back normal. The cardiac issues resolved in 2 days, but the other symptoms persisted (lips tingling and skin crawling). It took about 3 weeks for all symptoms to resolved. I did go see a neurologist who ruled out any neurological conditions. I also noticed I am now allergic to peanuts and hazelnut- oral itching, tingling and increase in phlegm and draining.
57 2021-07-01 pain in extremity I was at work and my arm started feeling very sore. It started hurting. By the time I got home from ... Read more
I was at work and my arm started feeling very sore. It started hurting. By the time I got home from work, my body was starting to ache. It progressively got worse to where I couldn't do anything. It was like everything hurt and I was like that for 3 days. I was a little bit better for about 3 weeks and it started all over again. It was to the point that I would go to work, come home, sleep, get up in the morning, get dressed, go back to bed, and then finally go to work. My legs, feet, ankles, knees all hurt. I could barely walk. I have a high pain tolerance. I was putting something in the refrigerator and got on my knees and starting sobbing because it hurt so much. I went to the doctor and they had me take some Tylenol and Aleve. It didn't help. Then my feet were swelling so bad that they were huge. I went back to the doctor and they ended up doing some blood work. They ended up testing me for rheumatoid arthritis and my numbers were very high. Now I have to see a rheumatoid arthritis doctor and he has me on some medicine. They had to put me on steroids to bring all the swelling down. It is somewhat manageable now, but it still hurts. I was in so much pain that I almost went to the ER, but I never did.
57 2021-07-04 pain in extremity 1. April 10-13: 3 days of sickness, chills, fever 102, arm extremely painful, all over body aches, n... Read more
1. April 10-13: 3 days of sickness, chills, fever 102, arm extremely painful, all over body aches, nausea, SVT heart racing 120 bpm. 2. Later in April and May had 3 episodes of SVT: heart racing up to 220 bpm 3. Late May: Great fatigue, too tired to drive safely, sleeping mid-day naps for hours, VERY unusual for me. 4. DIZZY, lightheaded, headaches, head foggy, nausea
57 2021-07-05 weakness Loss of hearing in left ear next morning after -very high temp started next night around 5pm with ch... Read more
Loss of hearing in left ear next morning after -very high temp started next night around 5pm with chills- passed out going up stairs to bed my husband called 911 thought I had a stroke but didn't. went to bed very weak that night and next day ran high fever bad headache for two more days went to urgent care and ER 3 days after vaccine. Nothing was found to be wrong with me bus they diagnosed a very bad ear infection which I didn't have prior to vaccine. Unable to eat and was very weak for another week. Had to seek ENT to help with ear, Gave me steroid. still have some hearing loss and crackling in my ear
57 2021-07-05 discomfort General disconfort, fever, headache, cough
57 2021-07-05 difficulty speaking, burning sensation it is more of a burn or a side effect; Back started hurting; she noticed a rash on her face too; Tin... Read more
it is more of a burn or a side effect; Back started hurting; she noticed a rash on her face too; Tingling and swollen tongue; Tingling and swollen tongue; Rash on the neck/Rash: it started right around then. It was right around her chest, up her chest/ Now it is in the middle of her neck and up to her chest; Felt itchy here and there; Voice changes like it got thicker and heavier; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8737), via an unspecified route of administration at the age of 57-year-old administered in arm left on 18Jun2021 2:50 pm at single dose for covid-19 immunisation. Medical history included hypothyroid (Maybe like 18 years she has had it), discoid lupus (it was probably in the year 2000 she was diagnosed). Concomitant drugs included thyroid drugs (unspecified) and vitamins. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks), there was no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient received her first dose of the Pfizer covid-19 vaccine last Friday, and then two hours later she was in the Emergency Room due to a tingling, swollen tongue and rash on the neck on18Jun2021. She was treated with Benadryl, prednisone, and IV fluids. She thinks it was probably swollen some as well as having a rash on her neck that has still not gone away. The consumer reports she still has a light pink rash on her neck. Treatment, tongue tingling and swollen, felt itchy here and there on 18Jun2021, the patient stated what happened was two hours after the vaccine she felt itchy here and there but then she went to lay down and her tongue was tingling and she was like okay and trying to focus on what was happening. After a while, she felt her tongue swelling kind of in her throat, too, and it was like she tried to swallow hard and swallow and her husband took her to the ER and they gave her IV with Prednisone and Benadryl and sent her home with a pack of Prednisone - like a linger off pack - and Benadryl. The patient stated this all occurred on Friday, which was 18Jun2021. That went away but she has not gotten it again. Rash started right around then. It was right around her chest, up her chest, and it has gone down. Now it was in the middle of her neck and up to her chest. She feels like it has gotten better, but was still there. She first noticed it when she got home from the ER, she noticed a rash on her face too on 18Jun2021. The patient asked if call handler was registered nurse. The patient stated she called her primary this morning because she wanted to get in where they can check her and see if something was wrong. They would not see her because she had a rash and they could not let her come in. She states that they can not let her there because she has a rash and she told them it is more of a burn or a side effect. They were going to call her via video tomorrow since they do not want her in the office. The patient asked if she should continue to take the Benadryl and she does not even know at this point, she was still taking the Prednisone. Patient stated that her voice also changes, it got thicker and heavier at the same time on 18Jun2021. This was still not going on, she was speaking fine now. The patient adds her back started hurting on 21Jun2021. She did not know if it was related. It started this afternoon and it was still just there. The patient was not hospitalized. Adverse events results in Emergency Room Visit and Physician Office Visit. She received the vaccine at 2:50 pm and went to the ER at 6:08 pm. The patient added that she was discharged from the ER at 10:15 pm and was not admitted to the hospital. The outcome of event "Back started hurting" was not recovered, of event "it is more of a burn or a side effect" and "she noticed a rash on her face too" was unknown, of event "Rash on the neck/Rash: it started right around then. It was right around her chest, up her chest/ Now it is in the middle of her neck and up to her chest" was recovering and other events was recovered.
57 2021-07-06 muscle spasms Burning throat 5 minutes after injection. Day after injection- sore throat, fever, body aches, naus... Read more
Burning throat 5 minutes after injection. Day after injection- sore throat, fever, body aches, nausea, vomiting, extreme thirst, arm burning, arm swollen, arm temperature hot, ear pain left side, neck pain left side, muscle cramps
57 2021-07-06 muscle spasms Started with back spasms on first day; subsided. Returned again the next day; subsided. On third day... Read more
Started with back spasms on first day; subsided. Returned again the next day; subsided. On third day pain became unbearable, went to Hospital ER - they diagnosed kidney stone. Had various blood and urine tests. CT scan confirmed. Administered a lot of IV meds. Was admitted for observation. Stent was put in place and kidney infection discovered. Sent home for 10 days to take antibiotics. On day 14 had urinalysis. On day 18 had stone surgically removed, stent replaced. On day 29 had stent removed.
57 2021-07-06 tenderness Day 6 post second injection developed raised rash with itching, swelling, tenderness & warmth.
57 2021-07-07 numbness, tingling, pain in extremity 48 hours after vaccination of 1st dose (Phizer), I felt discomfort in my feet: numbness, tingling, p... Read more
48 hours after vaccination of 1st dose (Phizer), I felt discomfort in my feet: numbness, tingling, pulling pains. Within 2 hours after the first symptoms, the pain in the left foot began to increase and became so severe that it was not possible to step on the left leg or make any movements with the foot. This state continued for a whole day (about 24 hours). After that, the sharp pain in left foot disappeared, but unpleasant sensations in the legs still remained - heaviness, tension, numbness, periodic pulling pain (not severe)
57 2021-07-07 numbness Shingles - pain, itching, numbness. Front and back right side of midsection
57 2021-07-07 unresponsive to stimuli, cold sweat, feeling hot pt felt hot and clammy after injection, stated felt like she might pass out. pt sat in chair and slo... Read more
pt felt hot and clammy after injection, stated felt like she might pass out. pt sat in chair and slowly became unresponsive but never had any breathing issues. EMS was called and an ammonia inhalent was used. Pt responded to ammonia and was alert when EMS arrived. Pt was alert and coherent and vitals were stable. Pt refused transport to hospital.
57 2021-07-08 migraine Tongue swelling; Tight chest; Wheezing; Very tired; Migraine; Worsemuscles hurt; This is a spontaneo... Read more
Tongue swelling; Tight chest; Wheezing; Very tired; Migraine; Worsemuscles hurt; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6208) via an unspecified route of administration in the left arm on 24Mar2021 at 01:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraine, fibromyalgia, pseudotumor cerebri, arthritis and the patient was allergic to latex, sting, PCN and fruit. Concomitant medications included tizanidine (MANUFRATURER UNKNOWN), erenumab (AIMOVIG), famotidine (MANUFRATURER UNKNOWN), pregabalin(LYRICA) and hydromorphone hydrochloride (DILAUDID), all were from unknown date and for unspecified indication. The patient previously received thimerosol (MANUFRATURER UNKNOWN), naproxen (MANUFRATURER UNKNOWN), promethazine, penicillin (MANUFRATURER UNKNOWN), prochlorperazine malate (MANUFRATURER UNKNOWN), droperidol (MANUFRATURER UNKNOWN), codeine (MANUFRATURER UNKNOWN) , acetazolamide (DIAMOX), povidone iodine (MANUFRATURER UNKNOWN) , ceftazidime (MANUFRATURER UNKNOWN), trimethobenzamide (MANUFRATURER UNKNOWN) , buprenorphone; naloxone (SUBOXONE), cefuroxime (ZINACEF), methadone (MANUFRATURER UNKNOWN) and polymyxin topical (MANUFRATURER UNKNOWN), all on unknown date and for unspecified indication and patient experienced drug allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Mar2021 at 02:00, the patient experienced tongue swelling, minor tight chest, wheezing, very tired, migraine and worse muscles hurt. The patient did not receive any treatment for adverse event. The clinical outcome of the events tongue swelling, minor tight chest, wheezing, very tired, migraine and worse muscles hurt was recovered on unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
57 2021-07-08 tingling Tingling in finger tips on left hand and next day tingling in finger tips on right hand Still very i... Read more
Tingling in finger tips on left hand and next day tingling in finger tips on right hand Still very intense tingling in finger tips 3 weeks later
57 2021-07-09 migraine First reaction didn't happen until several hours after shot hives. This morning I woke up with seve... Read more
First reaction didn't happen until several hours after shot hives. This morning I woke up with severe pain in injection sight neck pain , severe migraine and the chills, Over all feeling of tiredness and ache all over. not running a fever. chest is feeling slightly tight when trying to take a deep breath.
57 2021-07-10 breast pain Experienced mild to moderately severe pain in left breast that lasted from 5/28/2021 to 6/18/2021. ... Read more
Experienced mild to moderately severe pain in left breast that lasted from 5/28/2021 to 6/18/2021. Most of the time pain was 5 of 10. But at times like raising arm or random times pain was 7 of 10. On 6/8, had visit with nurse practitioner who believed the pain was due to hormone replacement therapy.
57 2021-07-10 feeling cold Her feet feels like they are swollen; Dizziness; Nausesation; weird feeling from her knees down. It ... Read more
Her feet feels like they are swollen; Dizziness; Nausesation; weird feeling from her knees down. It is like a coldness, it feels like she has wet socks on. She feels it down to her ankles; weird feeling from her knees down. It is like a coldness, it feels like she has wet socks on. She feels it down to her ankles; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0173; Expiration Date: Aug2021), dose 1 via an unspecified route of administration, administered in Deltoid Right on 05May2021 around 2'clock or 3'clock (57 years age at the time of vaccination) as dose 1, 0.3 mL single for COVID-19 immunisation at Other- Stadium. Medical history included ongoing Pseudo Tumor (Has a VP shut for this), Kewari-1 (Commented this is a congenital birth defect), ongoing Renal dysplasia (Commented she has a stent in her kidney for this), ongoing all her valves are leaking, Tethered spinal cord (Had surgery for this years ago). Concomitant medications included blood pressure pills and a water pill, but no additional details provided. Patient reported that after first dose patient has had a weird feeling from her knees down. It is like a coldness, it feels like patient has wet socks on. Patient felt it down to her ankles. Patient was wondering if patient should get the second dose on 26May2021. Weird Feeling from knees down: It started that night on 05May2021. Patient was having issues with her shoes. Patient feet felt like they are swollen. Patient mentioned she does takes a water pill and has a VP Shunt. Her shoes feel tight on her. It is like Patient was retaining water. Patient was having swollen ankles and her feet were swollen. When probed for outcome and if event was still ongoing patient stated it was coming and going. Patient also later added Patient was having dizziness. It was periodically. Clarified it started the next day, 06May2021 . When probed for outcome patient sated it was like patient gets period of it. It was like a little vertigo. It comes and goes. Patient later clarified and confirmed outcome as it was getting better. Nauseation started the following day, on 06May2021. Patient initially stated it was pretty much going away. Later clarified and confirmed it has gone away. Patient had a little bit yesterday, but now Patient has recovered completely. The outcome of event Dizziness was recovering, for Nausesation was recovered on 16May2021 and for all rest events was unknown.
57 2021-07-10 numbness Pt reported numbness on the left side of face by left eye and mouth. Started morning of 7/11/21, 2 d... Read more
Pt reported numbness on the left side of face by left eye and mouth. Started morning of 7/11/21, 2 days after vaccination on 7/9/21.
57 2021-07-10 pain in extremity did not feel good for about 4-5 days; sore arm; This is a spontaneous report from a Pfizer sponsored... Read more
did not feel good for about 4-5 days; sore arm; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer(patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0168 and expiration date: not reported), via an unspecified route of administration, on 13Jun2021 (at the age of 57-year-old), as DOSE 1, SINGLE for covid-19 immunization. Medical history included covid-19 in Nov2020. The patient's concomitant medications were not reported. After the first dose, for about 4-5 days patient did not feel good, had sore arm and felt like she is coming down with something but never did. The patient's second dose is scheduled on July 6, She would like to know if she can take her second dose earlier than 06Jul.The patient would also like to know about antibodies after covid infection and vaccination. The outcome of the event 'did not feel good for about 4-5 days' was recovered in Jun2021 and that of sore arm was unknown at the time of reporting.
57 2021-07-11 migraine with aura next night big, red, hot, flat, nonitchy rash on right forearm; migraine aura of paresthesias.; red,... Read more
next night big, red, hot, flat, nonitchy rash on right forearm; migraine aura of paresthesias.; red, hot, and itchy on my right ankle area; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 18:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included migraine with prolonged aura, Hashimoto's disease, OSA (obstructive sleep apnea), airborne allergies, and obesity. The patient had known allergies to latex, pollens, mold, dust mites, and cats. Concomitant medications included thyroid (ARMOUR THYROID), verapamil (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), and EFFEXOR XR; all taken for an unknown indication and received within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 18:00, the patient had a migraine aura of paresthesia, immediately on vaccination, and developed first rash in the night, on the right ankle area, which was red, hot and itchy. On 25Mar2021, the next night, the patient experienced second rash on the right forearm, which was big, red, hot, flat, and non-itchy. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of the events migraine aura of paresthesia, first rash in the night, on the right ankle area, which was red, hot, and itchy and a second rash on the right forearm which was big, red, hot, flat, and non-itchy were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-07-12 weakness, difficulty speaking Joint ache, fatigue, weakness, tightness or chest and throat, sore throat, hoarseness, dizziness, co... Read more
Joint ache, fatigue, weakness, tightness or chest and throat, sore throat, hoarseness, dizziness, confusion, heartbeat (irregular), upset stomach, feeling tired / unwell.
57 2021-07-12 numbness, tingling Patient started noticing sensations of tingling and numbness in the forearms (elbows down) and legs ... Read more
Patient started noticing sensations of tingling and numbness in the forearms (elbows down) and legs (calves down). Symptoms started 2 days ago. Symptoms most noticeable last night. Patient describes them as barely noticeable and says they do not limit her day to day activities or movement. No aggravating or remitting factors. Not associated with any changes in lifestyle or medications, other than stopping a keto diet 5 days ago. Patient was reporting for her second dose of vaccine. I declined to administer the vaccine today and advised her to call her PCP for follow up care.
57 2021-07-12 muscle spasms All of a sudden I?ve been having lower leg cramps. Both legs. It?s like Charlie horse but severe whe... Read more
All of a sudden I?ve been having lower leg cramps. Both legs. It?s like Charlie horse but severe where I have to get up and walk to fix it. Woke me up at night. Happened twice now.
57 2021-07-12 muscle spasms Lower back pain Back spasms Permanent lower back pain I feel like there?s damage done. I?m waitin... Read more
Lower back pain Back spasms Permanent lower back pain I feel like there?s damage done. I?m waiting for more diagnosis
57 2021-07-14 pain in extremity Pain and mild swelling in left arm which had previously resolved lymphedema. Shot was administered i... Read more
Pain and mild swelling in left arm which had previously resolved lymphedema. Shot was administered in right arm.
57 2021-07-15 pain in extremity Pain in left arm at the injection site. Has become difficult to move my left arm most of the time.
57 2021-07-15 tremor, inability to speak Patient felt light-headed after 5 minutes of vaccination, experienced dizziness, syncope, and was re... Read more
Patient felt light-headed after 5 minutes of vaccination, experienced dizziness, syncope, and was required to lay down. After 15 minutes she experienced shaking that continued until 5:50 PM. Patient was alert the entire time, no problems breathing, some problems speaking. We called 911 after 10 minutes; however, patient refused EMT transport, and had family members pick her up at 5:50 PM.
57 2021-07-17 weakness, numbness, electric shock sensation, feeling hot, tingling, pain in extremity 4 minutes after receiving the first Pfizer vaccine shot, I felt a wave of tingling heat pass down th... Read more
4 minutes after receiving the first Pfizer vaccine shot, I felt a wave of tingling heat pass down through my body. My only pain the first day or so was a sore arm and shoulder. Within 2 days, I noticed increasing joint pain, foggy brain, and mild headaches. I also noticed a circular rash on my vaccinated arm, not at the injection site. Symptoms increased. By day 6 the joint pain was unbearable. I was treated with doxycline for potential Lyme, though I tested negative. I also took Ibuprofren for the pain for a few days. Since then, the symptoms have continually increased, and have restricted my activities. After the first 2 weeks, I could still "loosen up" all the joints, which popped loudly - even toes and fingers, but especially ankles, knees, hips, shoulders and upper spine and neck. Then followed a month of more constant pain, and numbness and tingling in my right hand and across upper back. Headaches and upper back pain kept increasing. Sleep affected, with joint pain beginning each afternoon 4-5 p.m., climaxing around 3-4 a.m. 5/27, 2 months after the Pfizer vaccine shot, the right side of my head suddenly went numb. Vision and hearing impaired in the right side also. At the periphery of the numbness, intense itching, that slowly spread from the epicenter of the numbness. A drooping feeling in the right cheek, jaw pain. Nausea. Numbness slowly abated after 2 hours. By the next morning, the right side of my face itched, one small spot at a time. Itching remains in spots all over my body, 2 days later. 7/18 - symptoms are still increasing in number and strength- numbness on the tip of my tongue and lower lip. Jaw pain and metallic taste in my mouth, extreme neck/shoulder pain, foggy brain, internal tingling and electrical-feeling vibration in muscles, heart palpitations, high blood pressure, popping joints, weakness, shortness of breath. These sensations diminish in the morning, then increase as each day goes on, and are very distracting and painful by each evening. I am unable to work a full day, or exercise as I used to before the vaccine.
57 2021-07-17 numbness swelling of face and throat; swelling of face and throat; bad rash all over body; numbness on her fa... Read more
swelling of face and throat; swelling of face and throat; bad rash all over body; numbness on her face; allergic reaction from her nose down to her chin; tongue still feels heavy; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer (patient) reported for herself. A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0202, Expiry date: unknown) via an unspecified route of administration in Arm Left on 27Jun2021 14:45 (at the age of 57-years-old) as single dose for covid-19 immunization. Medical history included patient was diagnosed about 10 or 20 years ago for thyroid nodules from an unspecified start date and ongoing. Family medical history includes: Father has high cholesterol, no cancer in her family. Her dad has thyroid conditions. Patient didn't have any other vaccine prior to vaccination (within 4 week) and no adverse event prior vaccination. Concomitant medication included thyroid (ARMOUR THYROID) taken 0.25 one tablet daily for thyroid nodule. Sign of severe allergic reaction include swelling of face and throat, bad rash all over body. Upon follow up on 29Jun2021 patient reported that on 27Jun2021 15:20 patient experienced allergic reaction from her nose down to her chin, her face was numb like she had Novocain. And when patient woke up in morning and recovered (28Jun2021) from numbness in her face but tongue still feels heavy. Patient states she had COVID, and it was not severe and felt like it was not enough to put a vaccine in her body. She felt like with delta strain it may be more severe than the other strain. Patient feel like she was pressured to have it, took it for piece of mind. Patient received treatment for allergic reaction and numbness. The outcome of the event allergic reaction from her nose down to her chin, her face was numb like she had Novocain recovered on 28Jun2021 and tongue still feels heavy unknown. Referred to HCP for further clinical recommendations.
57 2021-07-17 migraine hair loss; migraine; Nausea; Fatigue; increase weight gain; no appetite; shooting pain in the muscle... Read more
hair loss; migraine; Nausea; Fatigue; increase weight gain; no appetite; shooting pain in the muscles; Insomnia for 9 days; This is a spontaneous report from a contactable nurse. A 57-year-old female nurse (patient) reported for herself. A 57-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0183, Expiration date: Unknown), via intramuscular route, administered in left arm (deltoid) on 20May2021 16:00 (at the age of 57-years-old) as dose 2, single for covid-19 immunisation in public health clinic/veterans administration facility. Medical history included known allergies. The concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0179, Expiration date: Unknown), via intramuscular route, administered in deltoid on 29Apr2021 (at the age of 57-years-old) as dose 1, single for covid-19 immunisation and no problem with first injection. On 20May2021 at 02:00 Am, the patient experienced insomnia for 9 days. On 21May2021 at 02:00, the patient experienced, hair loss, migraine, nausea For 4 weeks, fatigue, increase weight gain, no appetite, shooting pain in the muscles. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of insomnia for 9 days, migraine with smudging with SAGE disease and Tylenol 500 mg respectively. The event Insomnia and nausea were reported as Persistent/ Significant disability/ Incapacity, Important medical event, migraine was reported as Persistent/ Significant disability/ Incapacity, and hair loss was reported as Important medical event. The outcome of the event migraine was resolved on an unspecified date in 2021 and nausea was resolved on 15Jun2021, hair loss was not resolved and other events were resolving. Follow-up attempts are needed. Further information is requested. Follow-up: This is a follow up-spontaneous report from a contactable other HCP (nurse). This other HCP (nurse) reported in response to HCP letter via follow-up letter:; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported Insomnia, hair loss and Migraine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
57 2021-07-17 pain in extremity my left knee became very swollen, stiff, and painful.; my left knee became very swollen, stiff, and ... Read more
my left knee became very swollen, stiff, and painful.; my left knee became very swollen, stiff, and painful.; my left knee became very swollen, stiff, and painful.; I think I have arthritis.; Both knees&thumbs were inflamed, cracking, stiff, painful; This is a spontaneous report received from a contactable consumer or other Non-health care professional. This case was split to capture events after first and second dose of vaccine. This is the second of two reports, reflecting events after the 2nd dose. A 57-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0175) via an unspecified route of administration in left arm on 28Apr2021 (at a age of 57-year-old) as dose 2, single for covid-19 immunization. Medical history includes Relapsing Remitting Multiple Sclerosis (RRMS), high cholesterol, high triglycerides, high LDL, depression (acute PTSD 21Dec2013). Patient had allergies to Sulfa (rash), Nickel (ears bleed) allergies to medications, food, or other products from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0162) via an unspecified route of administration in left arm on 09Apr2021 08:00 (at a age of 57-year-old) as dose 2, single for covid-19 immunization and experienced unable to walk without a limp, soreness at the injection site, Slept more, Left kneecap was very painful, Dry cough and tickle in my throat, tickle in my throat. Concomitant medications included ocrelizumab (OCREVUS) taken for relapsing-remitting multiple sclerosis, start and stop date were not reported, atorvastatin (ATORVASTATIN); citalopram (CITALOPRAM); calcium, ergocalciferol (VITAMIN D2 + CALCIUM [CALCIUM; ERGOCALCIF-EROL]); all taken for an unspecified indication, start and stop date were not reported. she received 1st dose of the Pfizer Covid-19 vaccine (left arm). 10Apr2021: she experienced soreness at the injection site & slept more than usual. 11Apr2021: when extending my left leg on my ottoman, it felt like her knee was hyperextended. Left kneecap was very painful, and she had to use a pillow under that knee routinely for a few weeks. she woke up between 2:30-3:00am for a few weeks w/ dry cough & tickle in her throat. This has since resolved. she was unable to walk without a limp after my 1st Pfizer dose due to pain in left knee. After her 2nd Pfizer Covid-19 vaccine on 28Apr2021, her left knee became very swollen, stiff, and painful. On 22-May she had a full-blown flair of whatever this is. Both knees & thumbs were inflamed, cracking, stiff, painful. she thinks she had arthritis. she had RRMS for 27+ years & she am on Ocrevus. My B-cells are now "0". she believes the Pfizer vaccine has triggered an inflammatory arthritic response in her body. she sees a rheumatologist on 02Jul2021. The patient underwent lab tests and procedures which included blood immunoglobulin g: positive on 26May2021 Semi QN, blood test: unknown on Blood test, lymphocyte count: 0 on unspecified date. The clinical outcome of not recovered. No follow-up attempts are possible. No further information is expected.
57 2021-07-17 pain in extremity Severe Diarrhea; Soreness under the arms; This is a spontaneous report from a contactable consumer )... Read more
Severe Diarrhea; Soreness under the arms; This is a spontaneous report from a contactable consumer ). A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8733), via an unspecified route of administration in right arm on 31Mar2021 (at the age of 57 years) as dose 2 single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN61GG or may be 99 not clear) via an unspecified route of administration on 10Mar2021 (at the age of 57 years) as dose 1 single for COVID-19 immunisation and experienced little diarrhea. It was reported that patient called to report side effects other than listed on the paper. On 31Mar2021, the patient experienced severe diarrhea. On an unspecified date in 2021, the patient had soreness like soreness under arm. It was kind of sore under arm not where the shot was but underneath arm. Patient received treatment for severe diarrhea with loperamide (IMODIUM 2 mg, frequency: 3). The outcome of events were unknown. No follow-up attempts are possible. No further information is expected.
57 2021-07-17 pain in extremity slightly sore arm; tiredness; This is a spontaneous report from a contactable consumer, the patient.... Read more
slightly sore arm; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 15Mar2021 at 12:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medication included paracetamol(TYLENOL), CBD salve (MANUFACTURER UNKNOWN), biotin vitamin (MANUFACTURER UNKNOWN) and moringa tea (MANUFACTURER UNKNOWN)) from unknown date for unspecified indication. The Patient did not have any allergies to medications, food, or other products, but can't take ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the Patient had not tested for COVID-19. On, 15Mar2021 the patient experienced tiredness and slightly sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the tiredness and slightly sore arm was resolved on unknown date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-07-17 tingling, numbness Lacy rash; Mild sunburn appearance; Numbness/At 5+ weeks I still experience a kind of numbness; Ting... Read more
Lacy rash; Mild sunburn appearance; Numbness/At 5+ weeks I still experience a kind of numbness; Tingling/tingling in my arms, legs, lips and face; Unable to sleep for 3 days straight; Fatigued; Brain fog; Joint pain; Pain at injection site; Positive ANA after history of negative; This is a spontaneous report from a contactable consumer or other non-health care professional. A 57-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0173), dose 1 intramuscular, administered in Arm Left on 14May2021 09:00 as 1st dose, single for covid-19 immunisation. Medical history included known allergies to Penicillin, casein, nickel, thimerosal and PABA, Immune thrombocytopenia (ITP) and antinuclear antibody negative. Concomitant medications included ergocalciferol (VIT D), Glutathione and MVM. It was reported that patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks. On 17May2021 at 08:00, the patient experienced lacy rash which started 3 days after vaccine, numbness all over body positive ANA which is rising pain at injection site and joint pain. It was reported that patient underwent lab tests and procedures which included antinuclear antibody Positive ANA after history of negative ANA. 2 weeks post vaccination ANA was 1:640 and 5 weeks post vaccination ANA was 1:1280. Both showed the dense fine speckled pattern. ANA was tested because she developed a pronounced lacy rash all over 3 days post vaccination which disappeared after a day or two. That was followed by having a mild sunburn appearance all over with significant numbness and tingling, she was unable to sleep for 3 days straight, was fatigued, and had brain fog. At 5+ weeks she still experienced a kind of numbness and tingling in her arms, legs, lips and face, have fatigue and some brain fog. Also, patient tested positive for sars-cov-2 test on 17Jun2021. On an unknown date, patient was recovered from lacy rash and was not recovered from all other events. Follow attempts are needed. Additional information is expected.
57 2021-07-17 tingling Knee pain; Headache; Arm and Forehead Tingling; Room spinning; This is a spontaneous report received... Read more
Knee pain; Headache; Arm and Forehead Tingling; Room spinning; This is a spontaneous report received from a non-contactable consumer, the patient. A 57-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er2613), via an unspecified route of administration on 22Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the patient experienced room spinning, knee pain, headache, arm and forehead tingling. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events room spinning, knee pain, headache, arm and forehead tingling were not recovered. No follow-up attempts are needed. No further information is expected.
57 2021-07-17 tingling Patient felt dizzy right after the administration of the vaccine. She was asked to sit down and BP t... Read more
Patient felt dizzy right after the administration of the vaccine. She was asked to sit down and BP taken at that time was 139/99. Patient sat and drank some water and about 5 minutes later, BP was 135/95, and she said the dizziness improved a little. About 10 minutes later, patient said her hands were tingling and she felt nauseous. Patient was offered to drink and after a few sips, the nausea subsided. BP was retaken and it dropped to 125/94. Patient said she does not take any BP med but forgot to take her Flecainide dose for the evening. Patient claimed she felt much better after another 10 minutes and preferred to go home to lie in bed. Her husband accompanied her and said he would continue monitor her BP at home.
57 2021-07-17 tremor Pressure in chest; difficulty breathing; fast heartbeat; dizziness; shakiness; This is a spontaneous... Read more
Pressure in chest; difficulty breathing; fast heartbeat; dizziness; shakiness; This is a spontaneous report from a contactable consumer. A 57-year-old female patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6208), via an unspecified route of administration on arm right on 19Mar2021 04:15 AM (age at vaccination: 57 years) as DOSE 1, SINGLE for COVID-19 immunisation at Hospital. The patient medical history included Asthma and trouble sleeping. The patient had known allergies to Compazine. Other vaccine in four weeks was reported as no. Covid prior vaccination and covid tested post vaccination was reported as no. The patient Concomitant medications were not reported. On 19Mar2021 05:00 PM, the patient experienced Pressure in chest, difficulty breathing, fast heartbeat, dizziness, shakiness. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for all events and treatment included as Xanax for trouble sleeping. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
57 2021-07-17 trigeminal neuralgia Trigeminal neuralgia; soreness at the injection site; pain in every single joint on that left side (... Read more
Trigeminal neuralgia; soreness at the injection site; pain in every single joint on that left side (pain in that left ankle, left knee, left elbow, left wrist); My ankle and my leg totally swelled up I couldn't even walk; the pain is originating right like my hip, not my hip bone more towards my buttocks but on the bone.; My ankle and my leg totally swelled up I couldn't even walk; the pain is originating right like my hip, not my hip bone more towards my buttocks but on the bone.; My right side of my body, my elbow my hands, its very, it's not like it hurts it's swell and its hurts.; All my veins were sticking out of my arm; could see my veins through my hand; see they were right under my skin on both sides in my hands and both sides my lower arm.; I couldn't even move my arm.; She weight 117lbs 3 days ago. She weighs 113lbs; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration administered in left arm on 28Mar2021 at 12:30 (at the age of 57-year-old), as a single dose for COVID-19 immunization at Pharmacy/drug store. The patient medical history included ongoing chronic obstructive pulmonary disease, emphysema, anxiety, car accident (1998), bacterial pneumonia (2 years ago in November), pain, arthritis, anxiety and cannot sleep. When she was in a car accident and she had two surgeries on her and she needed a third surgery but she told the doctor no. She had a fusion, a laminectomy at C4 through C6. Her second surgery, her doctor told her that he couldn't fuse a plate to a plate in her neck, so the second surgery he removed the plate and fused C4 through C7. He told her if he fused C3 then she wouldn't be able to move her jaw. The doctor used cadaver bones on her first operation. She doesn't remember the doctor telling her if he fused C3 she wouldn't be able to move her jaw and the pain doctor put on 2 fentanyl patches and they were taking them off every 2 days and they kept doing epidurals and that's ridiculous. Her doctor asked her why she kept getting epidurals when her neck was fused. She reports this was in relation to a card accident she was in in Feb1998. In Nov2019, she went to sleep and she was throwing up in her sleep and she aspirated and she wasn't even sick. She went to bed and her husband woke up and heard her and called the ambulance and she ended up in the ICU for 3 days in a comatose state. She had no idea where she was. She didn't remember a thing. She woke up in the ICU and saw her daughter. She had to be sedated in the ICU, she reports she was punching the nurse. She was diagnosed with bacterial pneumonia. She stated she had no symptoms of pneumonia at all and she would know because she gets pneumonia every single year. They never tested her for Covid 19 in Nov2019. Maybe they didn't even know about Covid 19 at that time. She had COPD and couldn't got the shot earlier but had go to doctor to fill out, because he fills out these forms but she guess he didn't have any form that was available to fill out so you gonna see it today like and does not now she was able to get vaccine. 2 years ago in November, she had Pneumonia and everyone said that it was impossible that you have COVID but was on deathbed she was actually didn't remember anything when she went the bed until she woke up 4 days later, was in I.C.U for 3 days and wasn't able to get new appointment to get an test to see if she has antibodies to that, if had antibodies to the COVID because she couldn't even take appointment because they are making it so hard on things they don't have computer themselves and don't know how to do that on her cell phone to attach that Medicare card so she wasn't able to get appointment her daughter had to do it for me. Both her husband and she had COPD and she's sure she has emphysema.She has not been diagnosed with emphysema but her mother had it and she knows so much about things. She was in a car accident while a long time ago and had all kind of pain killers, currently on morphine sulfate extended release from years (she takes morphine immediate release 30mg just once a day when needed. She reports the morphine immediate release makes her speed up, like speed talking like she's a crazy. The dose is too much for her. It was prescribed when she weighed 98 lbs., now she weighs more) taken for pain at a dose of 60 mg twice a day and morphine sulfate immediate release at a dose of 30 mg as needed (once a day), alprazolam (ZOLAM) taken for severe anxiety at an unknown dose for four times a day, amitriptyline but not for depression but for as sleeping pills at a dose of 100 mg once a day (before bedtime), diazepam at a dose of 10mg four times daily taken for muscle relaxant therapy (she can't sleep very well) from an unspecified start date and ongoing. The patient did not take any prior vaccinations (within 4 weeks). Patient was still using the products and further stated that they never even asked her if she was on any kind of medicine or if ever had like any kind of bleeding disorder or anything like that and when she got home she got to leave the whole thing and what do you call it, she had 2 things Trigeminal neuralgia, she hated its like you are getting brain freeze but it goes to eye and its one of those painful conditions known to mankind and like its kind a irrational but when its really cold or she was under lot of stress it it comes back and always have to check with doctor if it happens again and she had COPD, never been diagnosed but she knows she have because her grandmother did and the other thing was bleeding thing its called Von Willebrand factor and that causes easy bleeding and bruising and she did not bruise or bleed easily but she knowns because they had to test her son when he was young and her ex-husband didn't have it and her mom and aunt were twins and they used to bruise easily both of them all the time and knew her son got it from her. Patient did not receive any prior Vaccinations (within 4 weeks) and did not had history of previous immunization with the Pfizer vaccine. Patient reported that, it wasn't an allergic reaction where she had to go the hospital and get a EpiPen or anything like that but she got the shot in her arm on Sunday (28Mar2021). When she went to sleep everything was fine but when she woke up she couldn't even move her arm and on 29Mar2021, she had the mild reaction of soreness at the injection but it was considerably the most that with her leg, ankle and leg totally swelled up, and couldn't even walk, she was supposed to go to doctor, but anyway she can't, she was driving and her legs with whole ankle swollen and it also its not going down side arachnoid nerve but the pain was originating right like in hip, not her hip bone more towards my buttocks but on the bone, she forgot her anatomy and then its affecting all her joints, she had pain in that left ankle, left knee, left elbow, left wrist, she had pain in every single joint on that left side except her hip because she already has pain in her hip. Her joint pain and swelling started the next day after the Covid 19 vaccine. She had arthritis (Intent:History) too but never got affected like this where everything will joint on her right side of my body, elbow, hands, its very, it's not like it hurts it's swell and its hurts. After receiving vaccine patient went to the doctor, couldn't get a schedule for today, so in two days or so, she make sure and was able to get vaccine again. Since 10 years of age, due to her son marriage with all work she was on her feet like 3 days then had run out at the very last moment and couldn't even dance or walk on her leg and don't remember if it was my right or left but the same thing happened. Swelled her whole ankle got swollen up and couldn't walk for 2 or 3 days. Further stated that all gone away. It was just she couldn't move up her arm at all yesterday." When confirmed that she got the first shot on Sunday, (Later confirmed as 28Mar2021). Patient had swelling only on left side but not right side. When she woke up this morning it look like all her veins were sticking out of arm that say its very weird way to describe the blood in veins (stated she could see her veins through hand, as anyone couldn't see them but see they were right under her skin on both sides in hands and both sides of lower arm actually). She put her legs up and feel may swelling goes down little more, her husband keeps on telling to walk on it but if she walk on it, it swells more. Her weight was 112 yesterday (as reported as probably). Now it was 111. Patient was concerned over the lady at the (name) that gave the Covid 19 vaccine. The lady at (name) didn't even asked what medications she's on. She's not allergic to anything but she was in a car accident a long time ago. For everything to swell up like that was ridiculous. She got the Covid 19 vaccine on the left side and her joints on the left side were terrible. It was only on her left side. She reports the joint pain and swelling is gone and only lasted a couple days. She's supposed to be resting but that's impossible when you have a 10 year old and a 13 year old living with her. All the swelling and joint pain occurred on the left side of her body, nothing on the right side. The same side as she got the Covid 19 vaccine in her left arm. She had to wait until she was eligible for the vaccine when they opened it up for people over 50 years old. Patient weighs 117lbs 3 days ago (as per report), now she weighs 113lbs and that's in clothes. When the patient went for regular physician office visit but she mentioned about the reactions to the vaccine that was pain and swelling in her joints on the left side. Patient did not receive treatments for the events. She was worried about going back and having anaphylactic shock with the second Covid 19 vaccine. She enquired who is going to give her the epi pen if she needs it. Her doctor said if she has any doubts, if she goes into anaphylactic shock, will get an ambulance and told her to expect to have a severe reaction to the second vaccine Covid 19. The reporter assessed the events as non serious. The outcome of the event soreness at the injection site was recovered on 30Mar2021 and the rests of the events was unknown.
57 2021-07-18 feeling hot My skin has become sensitive and itchy. Any abrasion causes redness and low hives - even holding t... Read more
My skin has become sensitive and itchy. Any abrasion causes redness and low hives - even holding the steering wheel. For the first day or two my skin felt hot -- similar to the feeling when you come out of a tanning bed. I was worried about getting the 2nd shot, but i did it. The skin condition continues, but it did not get worse with the 2nd shot. I did get the flu feeling that is the normal reaction (for 1 day). i am hoping that my skin gets back to normal soon.
57 2021-07-19 weakness Violently throwing up for 12 hours; Diarrhea; Chills; Sweats; tight chest; could not get out of bed ... Read more
Violently throwing up for 12 hours; Diarrhea; Chills; Sweats; tight chest; could not get out of bed for 3 days; don't feel myself; feeling achy; no energy; chest hurts; This is a spontaneous report from a contactable consumer (patient herself). A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6206) via an unspecified route of administration in left arm on 08Mar2021 01:45 as dose 1, single (at the age of 57-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19, prior to vaccination. Patient was not tested for COVID-19, post vaccination. Patient medical history was not reported. Patient had no known allergies. The concomitant medications included reflux medicines, hormones and allergy medicines. On 09Mar2021 at 04:00, patient started violently throwing up for 12 hours, diarrhea, chills, sweats, tight chest, could not get out of bed for 3 days. Even after 6 days from start of events on 09Mar2021 at 04:00, patient still did not feel herself, was still feeling achy, no energy, chest hurted. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received anti-nausea medicines to help with throwing up. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
57 2021-07-19 flushing Rash both sides of neck; itching; flushing of area; This is a spontaneous report from a contactable ... Read more
Rash both sides of neck; itching; flushing of area; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration in the right arm on 26Mar2021 at 11:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP), osteoarthritis, generalized anxiety, histoplasmosis, right orbital Arteriovenous malformations (AVM), trigeminal neuralgia, recurrent pneumonia and acid reflux. The patient was allergic to penicillin (PCN) and sulfa meds. Concomitant medications were not reported. The patient previously received metronidazole (FLAGYL) and had drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 22:30, the patient experienced rash on both sides of neck, itching and flushing of area. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of the events rash both sides of neck, itching and flushing was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
57 2021-07-19 pain in extremity, nerve pain very sore arm; 48 hr after injection developed PVC's - in/out of geminy for 3 days; generalized fati... Read more
very sore arm; 48 hr after injection developed PVC's - in/out of geminy for 3 days; generalized fatigue which worsened over time with worsening of pvc frequency; Shingles-type nerve pain left trunk; Shingles-type nerve pain left trunk; eruption of herpes in corner of mouth; scalp pain; unifocal pvc's at first, which slowly progressed into more frequent and multifocal pvc's , worsening with any increased activity; unifocal pvc's at first, which slowly progressed into more frequent and multifocal pvc's , worsening with any increased activity; This is a spontaneous report from a contactable Nurse (Patient). A 57yearsold female patient received bnt162b2 (PFIZER BIONTECH COVID19 VACCINE, solution for injection, Lot Number: EL3302, at age of vaccination 57 years), dose 2 via an unspecified route of administration, administered in Arm Left on 10Jan2021 15:00 as dose 2, single for covid19 immunisation. Medical history included Hypothyroidism and allergies (Mild latex, mild food allergies associated with latex). Concomitant medication(s) included levothyroxine, thyroid (ARMOUR THYROID), asa, colecalciferol (VITAMIN D), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10). Previously patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Dec2020 10:00 AM (Batch/Lot Number: ELO140) as dose 1, single for covid19 immunisation. From first injection patient experienced sore arm for few hrs, fatigued 2 days, felt cold (wore jacket) and x2days (afebrile). The patient did not receive any other vaccine in fourweeks. It was unknown if patient had covid prior vaccination. Patient did not test covid post vaccination. On 12Jan2021at 01:00 PM, the patient experienced very sore arm x 3 days, 48 hr after injection developed PVCs in/out of geminy for 3 days then geminy resolved but remained with what seemed like unifocal pvcs at first, which slowly progressed into more frequent and multifocal pvcs , worsening with any increased activity (ex: walking from parking lot to work place), generalized fatigue which worsened over time with worsening of pvc frequency. Lasted almost exactly 4 months from day of injection (15 weeks). About to request cardiology referral, increased ASA intake to 350 mg bid (was 81 mg qd) (selfprescribed) and pvcs progressively resolved over 4, 5day period then stopped completely. Energy returned. Also, developed scalp pain (abt 10 d, resolved then returned), then developed Shinglestype nerve pain left trunk, and also 2x over that 4 mo. had neareruption of herpes in corner of mouth (in remission x40 yrs). Patient received treatment for the event extrasystoles, and no treatment was taken for other events. The outcome of event scalp pain was recovered with Sequel.The outcome of event very sore arm, 48 hr after injection developed PVCs in/out of geminy for 3 days, unifocal pvcs at first, which slowly progressed into more frequent and multifocal pvcs , worsening with any increased activity was recovered on 15Jan2021. The outcome of the events all others was recovered on unspecified date 2021. No followup attempts are possible. No further information is expected
57 2021-07-19 pain in extremity I am worried that the vaccine has messed up my immune system and caused my RA to come back; I am wor... Read more
I am worried that the vaccine has messed up my immune system and caused my RA to come back; I am worried that the vaccine has messed up my immune system; My fingers started swelling; The pain and swelling in my hands is now excruciating and it is starting in my feet; My fingers are starting to twist and curl; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 57-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203 and expiration date was not reported), via an unspecified route of administration in arm left on 04Mar2021 at 12:30 as dose 2, single (age at vaccination 57-year-old) for COVID-19 immunisation. Medical history included rheumatoid arthritis from an unknown date, Thyroid Disease from an unknown, Hashimotos from an unknown date. The patient previously took levaquin and experienced hypersensitivity. Historical vaccine information included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number EL9261), via an unspecified route of administration in arm left on 12Feb2021 at 12:15 PM for COVID-19 Immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications within 2 weeks of vaccination includes compounded Thyroid med, compounded est/test cream. The patient reported that worried that the vaccine has messed up her immune system and caused RA to come back, her fingers started swelling, the pain and swelling in her hands was now excruciating and it was starting in her feet, her fingers were starting to twist and curl on 10Apr2021. Patient had RA in the past but had been in remission for over a year and a half. About a month after getting the 2nd COVID vaccination her fingers started swelling and hurting. The pain and swelling in her hands was excruciating and it was starting in her feet. Her fingers were starting to twist and curl. She was worried that the vaccine has messed up her immune system and caused her RA to come back way worse than it ever was. This was coming on fast and very severe. She won't be able to work much longer if something wasn't done to reverse the pain and damage. The patient underwent lab tests and procedures which included x-ray: unknown on an unknown date. Therapeutic measures were taken as a result of events includes medication for the pain and inflammation, x rays. The outcome of the events were not resolved. Follow-up actions are needed. Further information has been requested.
57 2021-07-19 pain in extremity patient receive full concentrated vial of Pfizer vaccine. Patients s/s over 4 day extreme fatigue, ... Read more
patient receive full concentrated vial of Pfizer vaccine. Patients s/s over 4 day extreme fatigue, head ache, body aches, extreme arm pain with raised bump that was red and warm to touch that has become itchy. 2 days after diarrhea and loss of apatite. Which has resolve.
57 2021-07-19 tingling Patient developed wheezing, face tingling all over but mostly on one side, throat tightness, difficu... Read more
Patient developed wheezing, face tingling all over but mostly on one side, throat tightness, difficulty swallowing but no trouble breathing, 20 minutes after receiving the 1st dose. These symptoms lasted for 10 hours until she used her inhaler.
57 2021-07-19 tingling Patient began to experience pins and needles in upper lip and left cheek within 15 minutes of vaccin... Read more
Patient began to experience pins and needles in upper lip and left cheek within 15 minutes of vaccination. Later that evening her chin, ears, and around her eyes developed hives and were very itchy. She also developed swelling under both arms the following day.
57 2021-07-20 burning sensation goosebumps; chills; chest was completely red; face was swollen a little more; getting panicky; the s... Read more
goosebumps; chills; chest was completely red; face was swollen a little more; getting panicky; the sides of her lips were burning; eyes were swollen a little; her mouth was swollen, on top of her mouth and the sides of her cheeks; there were hives on top of her palate/ getting hives all over; lips were swollen; her legs started itching/she was itching all over her body/ears were itching; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received an unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265; Expiration Date: May2021), via an unspecified route of administration on 02Feb2021 (at the age of 57-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she had the vaccine on 02Feb2021 (Tuesday) and she didn't felt bad. Then on 04Feb2021 (Thursday) her legs started itching and by 05Feb2021 (Friday) she was itching all over her body and her mouth was swollen, on top of her mouth and the sides of her cheeks, she could feel with her tongue on her palate, there were hives on top of her palate, after that day she was able to eat little by little because every time she would eat, her mouth would swell so she would stop and let it go down and then continue eating. She never felt like her breathing was compromised, she never felt like she could not breath. On 05Feb2021 (Friday) she was worse, so on Friday and Saturday (06Feb2021) she had hives on her body and her mouth was getting even more and her lips were swollen, everything was on the inside of her mouth. On 05Feb2021, she wrote itching down, she left out Saturday 06Feb2021 the top of mouth felt almost like she had hives but there was nothing major as the day progressed the sides of her lips were burning and she as itching all over body she was getting worse but still nothing major. There was nothing major Saturday night. Also 06Feb2021 at 10 pm she was getting worse she got home she was eating her mouth felt like it was itching, her ears were itching when finished dinner, she felt worse her eyes were swollen a little she took 2 Benadryl and by 10:30 she was better and at 10: 30 she fell asleep. On 07Feb2021 at 6:30 the inside of her lips, especially the top one was swollen and her palate was swelling and she read it and called CDC she called someplace else she tried to do that. Then 07Feb2021 (Sunday) she was itching on her body that was getting worse, she was getting hives all over her she went to work and worked until 9 still felt the same. Also, on 07Feb2021 she took pictures of the hives, she tried to eat breakfast. She clarifies she went to work on 07Feb2021 and she was getting panicky so she had to get someone to replace her, her mouth was swollen and by the time she got someone replace her it was like and hour later and she was a little better emotionally but she felt very scared. She takes pictures every day, she felt like that was important. She says she tried to eat breakfast every time she tried to eat her mouth gets more swollen, its her mouth not her throat. She says at 10:30 on 07Feb2021 she felt better with her swelling on her mouth, she was still itchy all over her body. She took 2 Benadryl and 1 Zyrtec. At 10 am she took pictures. She clarifies on 07Feb2021 she arrived home at 10 PM she took 2 Benadryl and Zyrtec, she fell asleep and the itching woke her up at 4:30 AM that would be Monday early AM. She applied Benadryl cream all over her body and she felt asleep, she woke up at 10 am and ate breakfast then felt asleep again. On the 08Feb2021 at 12:32 PM she woke up again and she was worse her chest was completely red and her face was swollen a little more, her itching was worse. She called her doctor she never answers. She took more pictures because it was worse she has written the pictures were taken at 12:30 pm. She has noticed a big difference yesterday and today her mouth was much worse before yesterday and today. On 08Feb2021, she went to the doctor at 4:30 and her doctor gave her an injection of some kind of steroid. No further information provided. She also gave her pack to take of steroids for 6 or 5 days and she prescribed an Epi pen. She said to take Benadryl every 4-6 hours and Zyrtec one time at night. She got up this morning and she was a little better now she was at work and she felt so bad, everything was itching, and she has goosebumps and chills but she has no fever she has not had a fever at all since got the vaccine. She has the packaging for her steroid. It says the name is Methylpred 4 mg pack (NDC 5974600103, lot number 20K0042P, expiration Aug2022). Day quantity 21 she thinks that is what it how many tablets. Outcome of the events her legs started itching/she was itching all over her body/ears were itching, her mouth was swollen, on top of her mouth and the sides of her cheeks, there were hives on top of her palate/ getting hives all over and lips were swollen was not recovered and was unknown for all other events. Follow-up attempts are completed. No further information is expected.
57 2021-07-20 pain in extremity Feet and legs swell and have pain, itch and subcutaneous hemorrhage. Heart rate increases. Heart h... Read more
Feet and legs swell and have pain, itch and subcutaneous hemorrhage. Heart rate increases. Heart has cardiopalmus and sometime feel stopping . The skin color of feet and leg becomes brown.
57 2021-07-20 pain in extremity Patient contacted the pharmacy that administered the vaccine informing us of the timeline of side ef... Read more
Patient contacted the pharmacy that administered the vaccine informing us of the timeline of side effects. Patient stated they had a sore arm the night following the administration of the vaccine but this subsided the next day. They then experienced nausea and stomach pain within a week of receiving the vaccine. The patient sought care and was found to have elevated liver enzymes. Patient said several tests were done did not give the dates etc. Contacted primary care doctor and they recommended contact local CDC office. The CDC office recommended starting a VAERS submission. Patient liver enzyme had started to normalize but are still elevated at this time.
57 2021-07-21 feeling hot Armpit pain; Hot to touch; large red looking welt approx 4-5 inches width; swollen lymph nodes armpi... Read more
Armpit pain; Hot to touch; large red looking welt approx 4-5 inches width; swollen lymph nodes armpit; swollen lymph nodes at site of injection; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 10:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient medical history included diabetes. Patient received other medication in 2 weeks which included dulaglutide (TRULICITY) for unknown indication and start date. The patient did not report any allergy to food, medication and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, 16 hours after 2nd vaccine, the patient woke at night with armpit pain, swollen lymph nodes armpit and at site of injection, hot to touch with large red-looking welt approx. 4-5 inches width. Three days later, still swollen at site, warm to touch with welt look and slight expansion of redness area. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/ department or urgent care. The clinical outcomes of the events armpit pain, hot to touch, large red-looking welt approx. 4-5 inches width, swollen lymph nodes armpit, swollen lymph nodes at site of injection were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-07-21 migraine Follow up report: Since I had the tightening in my chest that started everything in my chest on the ... Read more
Follow up report: Since I had the tightening in my chest that started everything in my chest on the 13th: That tightening in my chest now comes on much quicker. I have had to eliminate fragrances in my home (the ones I use to be okay with). That's bringing on asthma flares - more than usual I am getting more migraines - Would normally get 1 migraine every other month and now I'm getting one or two a week. I've called the nurses through med visits at clinic. Increased use of my inhaler. Less time outdoors. And more missed days from work due to the asthma but mostly from the migraines. I also had an Urgent Care visit - Toradol injection - for a headache that wasn't a migraine. It was a stabbing pain on the top of my head - a headache which I have never had before. The injection helped to resolve. I had a slight headache of that sort again three days ago, but it was nothing like it had been the first time. I just rested that evening (it came on at end of my workday) and it went away.
57 2021-07-21 pain in extremity Sore arm; Headache on the lower right side of head; This is a spontaneous report from a contactable ... Read more
Sore arm; Headache on the lower right side of head; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 31Mar2021 at 14:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, blood pressure high and arthritis. Concomitant medications included hydrochlorothiazide (+) olmesartan medoxomil (OLMESARTAN HCTZ), glimepiride (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. The patient was not allergic to food, medication or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 16:00, the patient experienced sore arm (pain in arm) and headache on the lower right side of head. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcomes of the event sore arm headache on the lower right side of head were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
57 2021-07-21 tenderness, feeling cold, pain in extremity The first day in the afternoon, I was tired with a mild headache. I had fever and chills. My tempera... Read more
The first day in the afternoon, I was tired with a mild headache. I had fever and chills. My temperature was 100.1 that night with a sore arm and body aches. The headache worsened later on in the day. On Wednesday April 14th, my highest fever was 100.7. My arm was still sore. I had nausea and didn't want to eat anything. I had a headache, body aches, and fatigue. On Wednesday night, I slept better and didn't have chills. On Thursday April 15th, I still had a headache, body aches, and fatigue. My arm pain was less. The nausea was less but still present. I had a temperature of 99.3. On Friday April 16th, I still had fatigue, a headache, and slight nausea. On Saturday April 17th, I was really tired and had a bad headache. Early that morning, I had red spots on my thigh, I noticed a patchy red rash on my forehead and other places on my body. The rashes were itchy. I also had a itchy patch on the back of my ear that had worsened. I tried medication creams for rash. My nausea came back. The next day, the itchy patches spread to the back of my knees, back, outer upper and inner forearms, and thighs. That morning I noticed flakes on my pillow when I woke up. That night I felt feverish and cold during the night. My fever was 99.2. My headache was significant, and I had nausea, itchy eyes, and fatigue. My scalp was itchy, and I had body aches. That evening I still had nauseas. The headache was less. Monday April 19th, I was better with no fever but a mild headache. The flaky skin had improved. On Tuesday April 20th, I was better overall. I just had a headache. On Wednesday April 21st, the dry skin behind the ears reappeared. I was tired and had a headache on and off. On Thursday April 22nd, I had on and off headaches and dry stuff behind my ears. The left and right side of my forehead felt tender and sore to the touch. On Friday April 23rd, I developed a scaly red patch on the back of my neck, and I had a headache. On Saturday April 24th, that spot on the back of my neck got really scabby. I had a headache, and I was tired. On Sunday April 25th, I was still tired. On Monday April 26th, the headache came back that evening. The neck and ear rash still bothered me. On Tuesday April 27th, I had a good day all day but the headache came back before I went to sleep. On Wednesday April 28th, the flaky patch behind the ears was better but still didn't go away. On Tuesday May 4th, the headache still comes and goes. The patches behind my ears and neck have improved but are still bothersome. On Thursday May 6th, I had a bad headache that evening. My doctor said I have eczema.
57 2021-07-22 inability to speak, involuntary muscle movements, feeling cold my throat became tight; my entire body went limp; could barely move my mouth to talk; within 25 minu... Read more
my throat became tight; my entire body went limp; could barely move my mouth to talk; within 25 minutes, i became extremely cold, dizzy, and then my entire body went limp; within 25 minutes, i became extremely cold, dizzy, and then my entire body went limp; I couldn't talk or move my neck or open my eyes, but I could hear; I couldn't move any part of my body except neck; I couldn't talk or move my neck or open my eyes, but I could hear; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 20Mar2021 11:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hemiplegic migraines, sjogren's syndrome, hashimoto's hypothyroidism, hypothyroidism, allergies: penicillin, wheat, and peanuts. Patient is not pregnant at time of vaccination. Concomitant medications included levothyroxine; erenumab aooe (AIMOVIG); and ubrogepant (UBRELVY) and OTC vitamins. The patient previously took verapamil, and acetazolamide and experienced allergy. Patient previously received Flu shot for immunisation and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 25 minutes, patient became extremely cold, dizzy, and then her entire body went limp. Patient couldn't move any part of her body except neck, and could barely move her mouth to talk. Within a minute, she couldn't talk or move her neck or open her eyes, but she could hear. An Epi-pen was administered into her right thigh and she was whisked off to ER on a gurney, where steroids and benadryl were also given through IV when her throat became tight. Adverse event start date was 20Mar2021 11:30 AM. Adverse events result in Emergency room/department or urgent care. Treatment Epi-Pen, steroids, Benadryl were received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included covid test type post vaccination (Blood test): positive on 22Apr2021, Covid test type post vaccination (Nasal Swab): negative on 22Apr2021. The outcomes of events were recovered on unspecified date. Information on lot/batch number has been requested.
57 2021-07-22 numbness, tingling, pain in extremity, burning sensation upper lip tingling; left side of face from forehead to chin, including eye, tingling/ left and right... Read more
upper lip tingling; left side of face from forehead to chin, including eye, tingling/ left and right cheeks tingling; swollen vaccine site; unable to lift arm; Lower lip numb and Lip numbness on both lower and upper lips/ upper lip moderately numb; left side of face from forehead to chin, including eye, numb/ chin numb; burning; sharp pain in lower lip; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204 COA) via an unspecified route of administration in the right arm on 13Mar2021 at 10:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included 2007 lyme's disease, but no symptoms since 2007. The patient had known allergy to codeine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) started on an unknown date for unspecified indication, loratadine (CLARITIN) started on an unknown date for unspecified indication and multivitamin (MANUFACTURER UNKNOWN) started on an unknown date for unspecified indication. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021, hours after vaccination, the patient experienced burning and sharp pain in lower lip. On 14Mar2021, the patient experienced swollen vaccine site, unable to lift arm, lower lip and chin completely numb. On 15Mar2021, the patient experienced left side of face from forehead to chin, including eye, tingling and numb, lip numbness on both lower and upper lips. On 30Mar2021, the patient experienced left and right cheeks, upper lip tingling and moderately numb and reduction in numbness to just lower lip and chin, from 22- 29 March, reduced to lower lip numbness only. No therapeutic measures were taken as a result of the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events burning, sharp pain in lower lip, swollen vaccine site, unable to lift arm, chin completely numb left side of face from forehead to chin, including eye, tingling and numb, lip numbness on upper lips, moderately numb, left and right cheeks, upper lip tingling was recovering and lower lip numb was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
57 2021-07-22 numbness pt presenting for 2nd dose Pfizer. Complaining of numbness of nose and perioral tingling. Patient ... Read more
pt presenting for 2nd dose Pfizer. Complaining of numbness of nose and perioral tingling. Patient had same reaction after first vaccination. No SOB or swelling. Exam negative. HR 72, RR 18, 91% on RA. No prior reactions to vaccinations or meds. Given po benedryl to take home.
57 2021-07-22 pain in extremity, feeling cold first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket).; first injection -... Read more
first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket).; first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket).; first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket).; This is a spontaneous report from a contactable other hcp (Nurse) (patient). A 57-year-old (non-pregnant) female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ELO140) via an unspecified route of administration, administered in arm right on 18Dec2020 10:00 (at the age of 57-year-old) at dose 1, single for covid-19 immunisation. Medical history included hypothyroidism, mild latex and mild food allergies associated with latex. Covid prior vaccination was unknown, covid tested post vaccination was no. Concomitant medications included thyroid (ARMOUR THYROID) taken for hypothyroidism; levothyroxine (LEVOTHYROXINE); ergocalciferol (VIT D); ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID; BETACAROTENE; CUPRIC OXIDE; MANGANESE SULFATE; SELENIUM; TOCOPHERYL ACETATE; UBIDECARENONE; ZINC OXIDE]); asa (ASA) at 81 mg, 1x/day, 350 mg, 2x/day. On an unspecified date in Dec 2020 the patient experienced first injection - sore arm for few hrs, fatigued 2 days, felt cold (wore jacket). Adverse event-(First injection-sore arm for few hrs, fatigued 2 days, felt cold(wore jacket).x2days (afebrile)). Second injection - very sore arm x 3days, 48 hr after injection developed PVC's - in/out of geminy for 3 days then geminy resolved but remained with what seemed like unifocal pvc's at first, which slowly progressed into more frequent and multifocal pvc's, worsening with any increased activity (ex: walking from parking lot to work place), generalized fatigue which worsened over time with worsening of pvc frequency. Lasted almost exactly 4 months from day of injection (15 weeks). Abt to request cardiology referral, increased ASA intake to 350 mg bid (was 81 mg qd) (self prescribed) and pvc's progressively resolved over 4-5 day period then stopped completely. Energy returned. Also, developed scalp pain (abt 10 resolved then returned), then developed Shingles-type nerve pain left trunk, and also 2x over that 4 mo had near-eruption of herpes in corner of mouth (in remission x40 yrs), adverse event start date-12Jan2021 adverse event start time-01:00 PM, (Lot number-EL3302, Lot unknown- False, administration date-10Jan2021, administration time-03:00 PM, dose number-2, vaccine location-Left arm). Patient did not receive treatment for the adverse events. Outcome of the events was resolved on an unspecified date. Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.
57 2021-07-22 pain in extremity This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnan... Read more
This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 09Mar2021 at 12:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took amoxicillin on unknown date for an unspecified indication and experienced drug allergy. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 at 16:00, the patient experienced sore arm and a little tired. Tiredness went away the next day and no other side effects. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sore arm was resolved on an unknown date in Mar2021 and a little tired was resolved on 10Mar2021. No follow-up attempts are possible. No further information is expected.
57 2021-07-22 pain in extremity My left arm, shoulder, under arm, armpit, and breast had a noticeable amount of edema that has not r... Read more
My left arm, shoulder, under arm, armpit, and breast had a noticeable amount of edema that has not resolved. Also by the end of week one my left knee was also swelling. Pain in arm is constant.
57 2021-07-23 feeling hot Beginning directly after immunization, patient asked if feeling hot (indicated chest up into neck, a... Read more
Beginning directly after immunization, patient asked if feeling hot (indicated chest up into neck, and that it felt like a hot flash) was typical. Given she was clearly getting worried, we took a BP, result 166/100 with pulse 112. Patient decided she wanted to sit and try to calm down, felt it could be anxiety, and asked for water. We gave water and some orange juice, which she thought might help. Within 10-15 minutes we retook BP, now 157/98 pulse 86. She noted feeling much improved, and after a couple minutes decided to leave, as she was feeling much better. Calling patient to check on her several hours later, she said it had just felt really odd, but that the feeling of hotness went away and she was feeling 100% improved
57 2021-07-25 numbness Fever, chills, headache for 2 days. In June the left side of my lip starting going numb, then it sp... Read more
Fever, chills, headache for 2 days. In June the left side of my lip starting going numb, then it spread to my tongue, chin and cheek (left side only).
57 2021-07-25 muscle spasms 01/29/2021 Felt lightheaded immediately after vaccine, nauseous, lymph nodes in neck swelled, one un... Read more
01/29/2021 Felt lightheaded immediately after vaccine, nauseous, lymph nodes in neck swelled, one under right arm was very big by bedtime. Fatigue. I had shortness of breath a few hours later. I have a difficult time catching my breaths sometimes too. Bad headache with sharp pain. Still experiencing these symptoms. Memory fog continues to this day. I have been accepted into the COVID clinic and will have my first visit on August 31st. Visited ER. I have also had debilitating widespread body cramps. 03/05/2021 Neck lymph nodes swelled, left and right. Headache was very pronounced but dull. All side effects from vaccine one persist into vaccine two. I continue to be extremely fatigued, I missed work the entire month of January. My neck is so stiff and this is a new side effect that just began with the second vaccine.
57 2021-07-25 pain in extremity After second dose of Covid vaccine, right arm and shoulder were sore/tender at injection site thru D... Read more
After second dose of Covid vaccine, right arm and shoulder were sore/tender at injection site thru Day Four. Within 24 hours had severe stomach and lower abdominal cramps. Within 36 hours had body aches, stiffness, sneezing, and was extremely tired. Third night had itching on arms, legs, and abdomen, nor visible rash. Symptoms started to ease by day four.
57 2021-07-25 tingling, pain in extremity Vaccines were administered. Patient reports upper arm pain in the left upper arm that has been ongoi... Read more
Vaccines were administered. Patient reports upper arm pain in the left upper arm that has been ongoing since getting her first COVID vaccine in March. She states her arm was swollen almost immediately after the first vaccine, she did not report this to anyone. Patient reports pain is worse with lying down, aching and tingling pain, constant pain like needles are sticking in her arm, and hurts when raising her arm up putting on her clothes. She reports no problems after the 2nd vaccine which was given in her right arm. She states that the arm did swell right after the injection but is not sure how long it took for swelling to go down.
57 2021-07-26 pain in extremity Pain at injection site/ Tender at site to pressure; Swelling/swelling on the left arm at injection s... Read more
Pain at injection site/ Tender at site to pressure; Swelling/swelling on the left arm at injection site; Stabs of pain shooting from the site down the length of arm.; Since the shots the shoulder also went into a chronic pain; This is a spontaneous report from a contactable consumer (patient). A 57-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on Apr2021 14:30 (at the age of 57-years-old) as dose 2, single for covid-19 immunisation in other facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included manage bursitis in right hip, mild inflammation soreness in shoulder 1 month prior to shot from 2021 to an unknown date (she had some mild inflammation soreness in shoulder 1 month prior to shot from working at home poor ergonomics). The patient did not have any known allergies. Concomitant medication(s) included naproxen taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 13Mar2021 13:30 (at the age of 57-years-old) as dose 1, single for covid-19 immunisation and experienced arm hurt, swelling on the left arm at the injection site and since the shots the shoulder also went into a chronic pain. On an unspecified date of Apr2021, the patient experienced pain at injection site/ tender at site to pressure, swelling/swelling on the left arm at injection site, stabs of pain shooting from the site down the length of arm and since the shots the shoulder also went into a chronic pain. The patient stated arm hurt after first shot in March and there was swelling on the left arm at injection site. Pain and swelling were still present when she received the second shot. It was now over 3.5 months past the second shot and she still have pain at injection site and swelling. She often has stabs of pain shooting from the site down the length of arm. Tender at site to pressure. She had some mild inflammation soreness in shoulder 1 month prior to shot from working at home poor ergonomics. Since the shots the shoulder also went into a chronic pain. About 8 weeks after receiving vaccinations She got a Cortizone shot in left shoulder to help eliminate pain. She has had 12 sessions of PT. Very painful when pressure was put on injection site. Physical therapist reported an increase of cases with people who had old shoulder injuries were coming in with flare ups. She doesn't know if the two are related but she was hoping the symptoms would have subsided after 90 days. Sometimes it is just a chronic ache at injection site. Therapeutic measures were taken as a result of the events with Cortizone shot in left shoulder to help eliminate pain. The events were considered non serious by the reporter. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
57 2021-07-26 tenderness I received the 1st dose of Pfizer vaccine on July 20th, 2021. I had muscle ache for the first two d... Read more
I received the 1st dose of Pfizer vaccine on July 20th, 2021. I had muscle ache for the first two days and couldn't sleep during nights. Starting on July 24th afternoon, I noticed left eyelid slightly swelling with no pain nor itchy. On July 25th morning, the swelling got a little bit worse. On following Monday (July 26th), the swelling started spreading and tenderness, but no pain. On Tuesday (July 27th) morning, the swelling further spread to the bridge of the nose and down to the upper lip. My boss, who is a physician, told me to take Claritin on July 26th, I did so. But, the swelling didn't get well today.
57 2021-07-27 cold sweat Skin hurt to touch chest tightness; Cough; Left lung pain; Tired; Clamy; Sleepy; Felt like flu; Skin... Read more
Skin hurt to touch chest tightness; Cough; Left lung pain; Tired; Clamy; Sleepy; Felt like flu; Skin hurt to touch; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Mar2021 at 12:00 hours (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (copd). Concomitant medications included pain meds (unspecified). The patient has no allergies to food, medication or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021 the patient experienced skin hurt to touch, chest tightness, cough, left lung pain, tired, clammy, sleepy and felt like flu. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events skin hurt to touch, chest tightness, cough, left lung pain, tired, clammy, sleepy and felt like flu were recovering. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03April2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-07-27 discomfort, inability to speak The next day after my second dose, I woke up at 6:00 am to start work (working from Home) and I real... Read more
The next day after my second dose, I woke up at 6:00 am to start work (working from Home) and I realized I was feeling feverish. I put on the heater but it did not help, I decided to call my boss at work to report sick and that was when I noticed I could not put words together. I was stuttering and shivering and my words were incoherent so my boss told me to either take Tylenol and go to bed or call 911. I took Tylenol PM and covered myself and went to sleep. I woke up at 4:20 pm and noticed I felt better and even sweating. I put off the heater and everything seemed fine. Then when I went to bed that night, I realized I was having shortness of breath and palpitations, I could hear my heartbeat in my chest. I propped up pillows and went to sleep feeling very uncomfortable. The next day it continued but I thought it will pass just like what happed the previous day. This continued on and off for some time but I still hoped it will pass until I decided to let my primary care physician know. She did an EKG and confirmed something was not right and referred me to a Cardiologist whom I'm yet to see.
57 2021-07-27 feeling hot feel like I get a little warm and it went away and then it came back and then; Mouth is dry; I feel ... Read more
feel like I get a little warm and it went away and then it came back and then; Mouth is dry; I feel my head was warm and my left arm was hurt; I feel my head was warm and my left arm was hurt; I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath.; muscles isn't right and then I have shortness of breath; short of breath; This is a spontaneous report from a contactable consumer/patient or other non hcp. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172 and expiry date: unknown), dose 2 via an unspecified route of administration on 21May2021 at 09:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. Any other medication : Consumer stated, "Not yet. The patient was calling to see if its okay to use asthma machine because the patient was having like panic attack. The patient was taking a solution for asthma (Albuterol). The patient do take Proventil for inhaler and also have Flovent and also have machine. The patient experienced a panic attack I am not sure because my head was warm for couple of second then I was short of breath on 21May2021 (I put one second Pfizer shot today and it was 9'o clock in morning and few minutes ago I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath), muscles isn't right and then the patient had shortness of breath on an unknown date on May2021, feel like i get a little warm and it went away and then it came back and then, mouth is dry and i feel my head was warm and my left arm was hurt on an unspecified date. No treatment was received for the events I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath. Outcome of the events I am having a panic attack I am not sure because my head was warm for couple of second then I was short of breath, short of breath, muscles isn't right and then I have shortness of breath, Mouth is dry, I feel my head was warm and my left arm was hurt was unknown, feel like I get a little warm and it went away and then it came back and then was not recovered. Follow-up (21May2021): This is a follow up-spontaneous report from a contactable consumer. Information on Lot/Batch number was available. Additional information has been requested.
57 2021-07-27 pain in extremity headache; arm hurt all the way up to neck L; arm hurt all the way up to neck L; dizziness; queasy; T... Read more
headache; arm hurt all the way up to neck L; arm hurt all the way up to neck L; dizziness; queasy; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) in the left arm on 19Mar2021 at 10:30 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history included supraventricular tachycardia (SVT), hypergamagolbulinaemia benign monoclonal, asthma, diverticulosis, fatty liver, clot blood, perimenopause and borderline diabetes. Patient reported allergies to latex allergy, sulfonamide allergy. The patient previously received KEFLEX, verapamil (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included acetylsalicylic acid (ASPIRIN) and enalapril maleate, lercanidipine hydrochloride (ZANEXTRA) from unknown date for an unknown indication received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced headache, arm hurt all the way up to neck L, dizziness, queasy on 19Mar2021. Details were as follows: on 19Mar2021, within 10 minutes after the vaccine, the patient experienced headache, left side pain all the way up to neck, queasy and dizziness. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the events. On 03Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was pending. The clinical outcome of experienced headache, arm hurt all the way up to neck L, dizziness, queasy was not recovered. No follow-up attempts are needed. No further information is expected.
57 2021-07-27 pain in extremity Slight itchy feeling underneath skin; Red unraised 2.5 inch circle around theinjection site- red ras... Read more
Slight itchy feeling underneath skin; Red unraised 2.5 inch circle around theinjection site- red rash like; Small raised bump size of nail bed; Arm felt slightly sore; Felt dizzy and lightheaded; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EN6207) via an unspecified route of administration in the right arm on 19Mar2021 at 16:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Concomitant medications included phentermine (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On (19Mar2021), Day 1 of initial injection, arm did not hurt. Day 2 (20Mar2021) experienced small raised bump size of nail bed (arm swelling) and arm felt slightly sore (pain in arm). On day 12 (30Mar2021), unknowingly found red unraised 2.5-inch circle around the injection site, red rash like (vaccination site erythema) slight itchy feeling underneath skin (pruritus). The patient felt dizzy and lightheaded for those 12 days as well. The patient called the 800 and asked if she should report it. She was informed that those were slight side effects that usually went away within 5 days after the shot. She asked if she should report considering it was well after that timeframe and she was informed that she could if she wanted to. She also had picture if needed. She was assuming that she had a slight allergic reaction but was wondering if anyone else had the same thing happened for that length of time. She decided to wait until the day before going to doctor. By then it had disappeared so she did not report it anywhere else. The patient was scheduled for her second dose on 09Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of light headed, arm swelling, pain in arm, vaccination site erythema and pruritus were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
57 2021-07-27 pain in extremity After receiving the vaccine I had the occasional sore arm and was experiencing chills for the first ... Read more
After receiving the vaccine I had the occasional sore arm and was experiencing chills for the first 3 days. Later on throughout the month I started to experience heart palpitations. I mentioned them to my PCP and he advised me to use a heart monitoring system until they could find out the reason why I was experiencing them out of nowhere. Also I have an appointment coming up to check out what is going on with my hip. I have been experiencing hip pain ever since receiving my 2nd dose of the vaccine. They are sending me to an orthopedic after they did an xray and seen how it was slowly deteriorating.
57 2021-07-27 tingling, pain in extremity Sore arm at shot location; Pins and needles sensation upper body; This is a spontaneous report from ... Read more
Sore arm at shot location; Pins and needles sensation upper body; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the arm left on 04Feb2021 at 13:00(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021 the patient experienced sore arm at shot location and pins and needles sensation upper body. Sore arm was still present 10 weeks after the shot at the shot location and pins and needles sensation in upper body off and on still. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore arm and pins and needles sensation upper body was not recovered. No follow-up attempts are needed. No further information is expected.
57 2021-07-28 weakness I started having dizziness about 24hrs after receiving the vaccine. This dizziness continues to this... Read more
I started having dizziness about 24hrs after receiving the vaccine. This dizziness continues to this day. It is sporadic. I can be lying in bed, and I will experience the dizziness. 2 weeks to the day after the vaccine, I started having unusual abdominal pain. 3 days later, I was hospitalized for three days. They thought it was a flare up of my Crohn's from the vaccine possibly. My Crohn's was stable before getting the vaccine. I was given IV fluids, high doses of steroids and pain medication. After the pain subsided and I was released, for 6 weeks after that, I was extremely tired and had extremely low energy. I completed my oral steroids 6 weeks after hospitalization. My Crohn's symptoms are now stable. I do continue to experience dizziness throughout the day. This is abnormal for me, I've never experienced chronic dizziness before.
57 2021-07-28 numbness, tingling Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial a... Read more
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: numbness and tingling in the left arm since the second dose. it comes and goes and she has not seen a doctor regarding this yet. She does have some relief when taking alleve. counseled to try alleve for a few days straight and then follow up with md if not resolved. Counseled may be temporary or possibly permanent
57 2021-07-28 pain in extremity Arm hurt; swelling on the left arm at injection site; This is a spontaneous report from a contactabl... Read more
Arm hurt; swelling on the left arm at injection site; This is a spontaneous report from a contactable consumer (Patient, self-reporting). A 57-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on an unspecified date in Mar2021 at 01:30 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. Medical history included manage bursitis in right hip and mild inflammation soreness. Patient had no past drug history. Concomitant medication included naproxen (NAPROXEN) 1 or 2 (500MG) tablets taken for an unspecified indication, within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 13Mar2021 at 14:30, the patient experienced arm hurt, swelling on the left arm at injection site. Arm hurt after first shot in march and there was swelling on the left arm at injection site. Pain and swelling was still present when she received the second shot. It was now over 3.5 months past the second shot and I still have pain at injection site and swelling. Patient often have stabs of pain shooting from the site down the length of arm. Tender at site to pressure and had some mild inflammation soreness in shoulder 1 month prior to shot from working at home poor ergonomics. Since the shots the shoulder also went into a chronic pain. About 8 weeks after receiving vaccinations she got a Cortizone shot in left should to help eliminate pain and had 12 sessions of PT. Very painful when pressure was put on injection site. Physical therapist reported an increase of cases with people who had old shoulder injuries were coming in with flare ups and do not know if the two are related but she was hoping the symptoms would have subsided after 90 days. Some times it is just a chronic ache at injection site. Facility where the most recent COVID-19 vaccine was administered was other only. The outcome of events were not recovered. Follow up information is excepted. Further information is requested.
57 2021-07-28 pain in extremity Initially, sore arm, headache, body aches. Shortly thereafter, extreme pain/inflammation in right hi... Read more
Initially, sore arm, headache, body aches. Shortly thereafter, extreme pain/inflammation in right hip/knee drastically affecting mobility
57 2021-07-29 seizure, weakness, numbness, paralysis Body aches; Headache; started moving around and was stiff and sore; Tired; Arm is sore shot was; Wea... Read more
Body aches; Headache; started moving around and was stiff and sore; Tired; Arm is sore shot was; Weak; convulsions; Paralyzation feeling; disoriented; dizzy; started to lose feeling in her arms/legs/could not get her legs to move; Breathing tighten; Head is full/head started to drop; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jul2021 (both 13:00 and 17:00 were reported) (Lot Number: FA6780) at 57 years old as single dose for covid-19 immunisation. Medical history included ongoing shellfish allergy, ongoing Blood pressure high, covid-19 from Dec2020 (she had covid in December and her husband had it real bad as well), allergic reaction, throat closes up, paraylzation feeling. Concomitant medications included medications for years (unspecified). She confirmed she did not feel it contributed to anything that occurred. The patient previously took flu shot for immunization and experienced arm would swell up. Three minutes into getting the vaccine the patient felt a little disoriented, dizzy. It was hard to explain. She mentioned she has an allergy to shellfish real bad. One thing that happens with her allergy to shellfish is a paralyzation. She stated after getting the COVID shot she started to have the parazalation feeling, she started losing feeling in her arm/legs and her head started to drop. She knew something was about to happen. Therefore, she called the lady over at the facility and two people came over to help lay her down. She could not get her legs to move. She then went into convulsions. Her brain was telling her to "do stuff but my body wasn't responding. She had the convulsions for a little over two hours and it was uncontrollable. They called the paramedics. Her breathing had tighten a little. This did not last long. The convulsions was the main thing. After this ended she was fine. She was fully aware and alert. During the convulsions she had no muscle control. After two hours, someone came to get her, but she could not move he legs. She collapsed and someone had to carry her to the car and into the house. She fell asleep and now she is fine today. She woke up with the headache this morning (16Jul2021). Body aches started this morning (16Jul2021). She started moving around and was stiff and sore. She noticed arm is sore where the shot was immediately when they gave it. However, it is really sore today. Head feels full started this morning (16Jul2021). She woke up with it. Weak started yesterday after the shot. She was wiped out. The weakness is better. After the convulsions she had tiredness and weakness. It's a little better than yesterday. She was totally wiped out yesterday. She was tired today. Treatment included that she took Benadryl immediately because she knew she would have to with allergies. She normally carries an Epi Pen with her, but she did not have to use the Epi Pen. Her breathing had improved quickly. She stated she keeps Benadryl in all sorts of containers and carries every with her. She stated she could go in the store, smell shrimp and have a reaction. She keeps the Benadryl on her at all times and not necessarily the bottle it came in. She stated when the ambulance came she refused to go to the hospital. She had the convulsions and gave it time to clear out. She thought about going to the hospital, but did not . She knew it would take a while for the shot to wear off and it would not be immediate. Her breathing was okay so she did not go to the hospital. She stated she knew with the convulsions this was something possibly with the allergic reaction. She then clarified the convulsions was new. Normally, with allergic reaction her throat closes up and she gets the paraylzation feeling. Her body then shuts down. The last time she had a bad episode she went into something similar to a seizure, but it was not as bad as this. This time she had uncontrollable jerking and shaking. This convulsion type ting was new. Events did not require a visit to Emergency Room or Physician Office. The outcome of event breathing tighten, weak and tired was recovering, head is full/head started to drop, body aches, arm is sore shot was, headache and started moving around and was stiff and sore was not recovered, others was recovered on 15Jul2021.
58 2020-12-31 flushing Face flushing about 30 minutes after vaccine followed by torso rash -- noticed on day after, which t... Read more
Face flushing about 30 minutes after vaccine followed by torso rash -- noticed on day after, which totally cleared by third day post-vaccine.
58 2021-01-03 flushing 15- 20 min following injection - heaviness in chest, 2-3 hours later - became flush, elevated blood ... Read more
15- 20 min following injection - heaviness in chest, 2-3 hours later - became flush, elevated blood pressure 169/92, pulse 100. Increased difficulty breathing.
58 2021-01-03 flushing 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain... Read more
30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; This is a spontaneous report from a contactable pharmacist. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), intramuscular on 19Dec2020 07:00 at SINGLE DOSE at Left arm for covid-19 immunization. Medical history included breast cancer female and allergies to shell fish and Latex. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 30 minutes after receiving vaccine on 19Dec2020 07:30 am, patient reported 'heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness. Patient was taken to the ED where she received IV Benadryl and was observed for 4 hours. Patient was discharged home and symptoms subsided. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of the events was recovered in Dec2020.; Sender's Comments: There is a plausible temporal relationship between immunization and onset of allergic reaction in a subject with a positive medical history for allergy to food (shellfish); causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-01-03 numbness I have lost hearing in my right ear; the right side of my face was numb; This is a spontaneous repor... Read more
I have lost hearing in my right ear; the right side of my face was numb; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number number EJ1685, expiration date Mar2021, on 25Dec2020 09:30 at single dose on left arm for Covid-19 vaccination. Medical history and concomitant medications were none. The patient had not received other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient received her first Covid-19 vaccination on Christmas morning. She worked at a medical center. Within an hour of when she got home, she lost hearing in one ear and also had some numbness on the same side of her face, She was wondering if that was something she should be concerned and she still didn't have hearing in her right ear. Treatment received for the events included Tylenol. The outcome of the events was not resolved.
58 2021-01-03 tremor patient began to experience dizziness/shakiness.; patient began to experience dizziness/shakiness.; ... Read more
patient began to experience dizziness/shakiness.; patient began to experience dizziness/shakiness.; This is a spontaneous report from a non-contactable other hcp reporting for a patient. A 58-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number: EH9899), intramuscular on 21Dec2020 16:00 at single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that during her 15 minute waiting period after the injection (21Dec2020 16:15), the patient began to experience dizziness/shakiness. This provider was notified of patient reaction and she was then transferred to the emergency bay via wheelchair where she was assessed. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with dyspnea, increased work of breathing, persistent cough and cyanosis, vomiting, hypotension, dysrhythmia, chest pain and collapse. Treatment included no therapy, but did continue with vital checks at approximately 5 minute intervals. Patient discharge: stable to go home and follow up with PCP. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the compatible time association, the dizziness and shakiness are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
58 2021-01-03 tremor The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the inject... Read more
The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the injection but at 2AM on the 22nd I woke up from my sleep with chills, and shaking even my teeth were clacking. Took Tylenol and it got better around 30 min later. Felt very fatigued and still nauseated almost threw up. By the end pf the day it resolved itself.
58 2021-01-04 difficulty speaking tested positive for COVID-19; headache; cough; voice being hoarse; Drug ineffective; This is a spont... Read more
tested positive for COVID-19; headache; cough; voice being hoarse; Drug ineffective; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect from a Contactable nurse reporting for herself. A 58-years-old female patient received bnt162b2 (BNT162B2; Lot # EK5730) vaccine , via an unspecified route of administration on 18Dec2020 10:30 at single dose for covid-19 immunisation . Medical history included hypertension from an unknown date and blood cholesterol increased. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), ezetimibe (ZETIA), famotidine (PEPCID). The patient started having a headache and cough on 25Dec2020 and these symptoms worsened on 26Dec2020 in addition to her voice being hoarse. On 26Dec2020 she went to get tested at an urgent center and tested positive for Covid-19. The outcome of the event was not recovered.; Sender's Comments: The association between the event "tested positive for COVID-19, headache, cough, and dysphonia" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-01-04 feeling hot, hot flush Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was emp... Read more
Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was employed as a housekeeper. About one hour after receiving the vaccine she experienced a hot flash, nausea, and feeling like she was going to pass out after she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours, upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed, then when medics arrived, she was still breathing slowly then went into cardiac arrest and was unable to be revived.
58 2021-01-04 flushing Flush; Itching; felt like she was going to wet herself; This is a spontaneous report from a contacta... Read more
Flush; Itching; felt like she was going to wet herself; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: unknown), intramuscularly in the upper left arm on 22Dec2020 at 08:48 at 58-years-old at a single dose for COVID-19 immunization; which was received at a hospital. The patient stated the hospital had a line for employees to drive up and receive the vaccine, she was in her car when the vaccine was administered. Medical history included ongoing allergy to sulfates from an unknown date (diagnosed at least 20 years ago). The patient had an allergy to sulfates. The patient had a bad reaction to sulfamethoxazole and trimethoprim (BACTRIM) many years ago. The patient did not have the Lot and NDC numbers, or expiration date to provide. The patient stated the reaction was so bad she had to receive multiple injections because her throat was closing off and she had big hives. This occurred years ago. There were no concomitant medications. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced bad reaction, throat was closing off and big hives from an unknown date to an unknown date. On 22Dec2020, the patient experienced: flush, itching, and felt like she was going to wet herself; all assessed as non-serious. The patient called about the COVID-19 vaccine. The patient was wondering if there was any sulfa in the vaccine. The patient had the vaccine on 22Dec2020, and she was fine for the first hour and then she became flush and started itching an hour later. The patient stated " you know when you get a CT scan and the contrast makes you feel warm down there", states she got that same feeling where she felt flush and where she was warm down there and she felt like she was going to wet herself. The patient stated, "the bladder feeling came on so harsh and fast." The patient took diphenhydramine hydrochloride (BENADRYL) for two days and she felt better. The patient later clarified that she recovered completely as of 25Dec2020. Therapeutic measures were taken as a result of flush and itching. The clinical outcome of the events, flush and itching, was recovered on 22Dec2020. The clinical outcome of the event, felt like she was going to wet herself, was unknown. There was no history of previous immunization with the Pfizer vaccine considered as a suspect. There were no additional vaccines administered on the same date of the Pfizer suspect. The events did not require a visit to an emergency room or physician office. The patient did not receive any prior vaccinations within 4 weeks of the suspect vaccine. There were no adverse events (AEs) following prior vaccinations. There were no relevant tests performed.
58 2021-01-04 pain in extremity Sore arm; fatigue; lightheaded; This is a spontaneous report from a contactable other health profess... Read more
Sore arm; fatigue; lightheaded; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 16:15 to 28Dec2020 16:15 at left arm, at single dose for covid-19 immunization. Medical history was none. Allergies to medications, food, or other products was no. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient was not pregnant at the time of vaccination. The patient experienced sore arm, fatigue, lightheaded on 29Dec2020 14:00. No treatment was received for all event. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about Lot/Batch number has been requested.
58 2021-01-05 weakness Pfizer COVID vaccine gine. Headsche weakness and extreme conjunctivitis present
58 2021-01-05 flushing Tachycardia, palpitations, elevated blood pressure, feeling faint, nausea, flushing
58 2021-01-05 numbness Both Legs Became Completely Numb; This is a spontaneous report from a contactable nurse (patient). A... Read more
Both Legs Became Completely Numb; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the right arm on 28Dec2020 07:45 at a single dose for COVID-19 immunization. The patient's medical history included diabetes and blood pressure (BP) abnormal. The patient was not pregnant. Concomitant medications included losartan potassium (LOSATAN), metformin, and amlodipine besilate (NORVAC), clopidogrel bisulfate (PLAVIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and experienced allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 29Dec2020 19:00, the patient was sitting and both of her legs became completely numb for 20 minutes and then the symptoms went away. This never happen before. No treatment was received for the adverse event. Outcome of the event was recovered on 29Dec2020 19:20. The event was considered non-serious. Information on the lot/batch number has been requested.
58 2021-01-05 muscle spasms Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to s... Read more
Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to sleep; Irritable mood; Muscle spasms; dry eyes; Dry mouth; brain fog, inability to multitask; This is a spontaneous report from a contactable nurse. A 58-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number: EJ1685; intramuscular in left arm on 18Dec2020 at 14:45 (at the age of 58 years-old) as a single dose for COVID-19 immunization. The vaccine was given in a hospital. The patient did not receive any other vaccines in the past 4 weeks. Medical history included asthma, mitral valve prolapse and an allergy to latex. Concomitant medication included calcium (CALCIUM), metoprolol (METOPROLOL), magnesium (MG [MAGNESIUM]), ergocalciferol (VIT D). The patient previously took penicillin and experienced an allergy. The patient did not receive any other vaccines in the past 4 weeks. She did take other medications (concomitant) in the past 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. In Dec2020, at 14:45, the patient experienced rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth, brain fog, and an inability to multitask after 1 week following COVID-19 vaccine. The patient was not hospitalized for the events and no treatment was administered. The outcome of the events: rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth. brain fog, inability to multitask, was recovering. Since the vaccination, the patient had not been tested for COVID-19.
58 2021-01-05 pain in extremity Headache; My arm is sore; This is a spontaneous report from a contactable consumer. A 58-year-old fe... Read more
Headache; My arm is sore; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (BNT162B2, batch number:5926710001), intramuscular in the arm on 30Dec2020 at a single dose for covid-19 immunisation. The patient's medical history included bacterial infection from an unknown date and unknown if ongoing. There were no concomitant medications. On 30Dec2020, the patient got the vaccine and had a little headache and her arms were sore. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
58 2021-01-05 pain in extremity Left arm sore; headache; generalized muscle aches; Temp at home in evening was 101.2; This is a spon... Read more
Left arm sore; headache; generalized muscle aches; Temp at home in evening was 101.2; This is a spontaneous report from a contactable Nurse (patient). A 58-year-old female patient receive first dose of BNT162B2 (lot number: EL1284) on left arm via an unspecified route of administration on 30Dec2020 15:45 at single dose for covid-19 immunisation. Medical history Environmental allergies, diverticulosis, uterine fibroids, and Known allergies: Broccoli and Bell peppers. The patient was previously diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (PROTONIX), levocetirizine dihydrochloride (XYZAL), famotidine (PEPCID), fluticasone furoate (FLONASE SENSIMIST ALLERGY RELIEF). The patient experienced left arm sore around 4 am 31Dec2020. Gradual onset of generalized muscle aches and headache. Worse as day progressed. Xhills late afternoon. Temp at home in evening was 101.2. The patient received tylenol (self administered) for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
58 2021-01-05 tingling LEFT SHOULDER AND NECK TIGHTNESS WITH FACIAL TINGLING AFTER LEAVING CLINIC. REFERED TO PRIVATE PHYS... Read more
LEFT SHOULDER AND NECK TIGHTNESS WITH FACIAL TINGLING AFTER LEAVING CLINIC. REFERED TO PRIVATE PHYSICIAN
58 2021-01-06 weakness body aches, weakness, sore throat, headache
58 2021-01-06 burning sensation hives, burning sensation around mouth
58 2021-01-06 pain in extremity Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third... Read more
Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third day, swollen lymph node to left neck lasting several days . Did not prevent me from doing anything.
58 2021-01-07 flushing 5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizzine... Read more
5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizziness and a feeling of rapid heart beat. Throat tightness and difficulty swallowing. Flushing sensation and feeling of rapid heart beat resolved within a few minutes, but left with nausea, flushing and difficulty swallowing/throat tightness.
58 2021-01-07 muscle spasms Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad t... Read more
Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; caused her to go into the flare; Muscle joints pain; Extremely tired; Muscle joints pain; Experiencing flu like symptoms; Body ache; Headache; sick; feeling bad; The initial case was missing the following minimum criteria: specific product. Upon receipt of follow-up information on 01Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 vaccination. Medical history included having something called Adult Still's which is bad Rheumatoid Arthritis. The patient's concomitant medications were not reported. The patient reported that she got the vaccine and was experiencing sever cramps in her legs and thighs, and muscle joints pain. She mentioned on a scale of 1-10 it is 20. The patient also experienced flu like symptoms which were body ache and extremely tired. The patient reported that she called because she received her first Covid shot on 17Dec2020 and she was really sick from then, she was talking like super sick. In Dec2020, she had muscle cramps, headache, no fever but like she had the flu. She has something called Adult Still's which is bad Rheumatoid Arthritis, so it caused her to go into the flare but she was still sick. She was still feeling bad. She was still having muscle pains in her leg. The patient mentioned that she had to go to the emergency room because she could barely move her leg. They told her that it was a combination of Adult still's and her Covid 19 shot, so they gave her some medications. They gave her Lyrica 75 mg, twice a day and it messed me up that she couldn't even function. So, now she had to come home from work and now she was still having the leg cramps and just not feeling well so what can she do to feel myself better. The outcome of the event cramps in legs was not recovered while the outcome of the other events was unknown. Information on the batch/lot number has been requested.
58 2021-01-07 muscle spasms severe neck pain; muscle pain that was almost like a horse in the muscles above her hips and in her ... Read more
severe neck pain; muscle pain that was almost like a horse in the muscles above her hips and in her back; muscle pain that was almost like a horse in the muscles above her hips and in her back; muscle cramping; pain in her arm; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number 5K5730/expiration date unknown), dose number 1, via an unspecified route of administration on 18Dec2020 at a single dose on the left arm for COVID Prevention. The patient had no relevant medical history. Historical vaccine included flu vaccine for immunisation which caused arm pain. The patient had no concomitant medications. She had no other vaccines on the same day as the COVID vaccine. The patient received her first dose of the COVID vaccine on 18Dec2020, and at first, she just had pain in her arm. It started getting sore in the evening of 18Dec2020. She suspected that would happen, because she gets that with the flu shot too. A few days after receiving the vaccine, she had pretty severe neck pain, and at first she just thought that maybe she slept wrong, but she still had neck pain. She was sitting with hand warmer packs on her neck because the pain was at the point bad enough that she could barely turn her neck. She experienced muscle pain that was almost like a horse in the muscles above her hips and in her back. The pain in her hips and back is bad enough that it almost takes her down. The patient also experienced muscle cramping. She further stated that she had not done anything different; she did not got to the gym. She remembered that when she signed off to get the vaccine, there was something about not taking the vaccine if someone had ever had a side effect to a lipid. The outcome of the events was recovered on 20Dec2020 for pain in her arm, recovering for neck pain, not recovered for muscle pain that was almost like a horse in the muscles above her hips and in her back, unknown for muscle cramping.
58 2021-01-07 pain in extremity Severe arm pain. Unable to open and close fingers. Back hurts Chills Cough
58 2021-01-07 pain in extremity Start with the normal sore arm continues on day five, normal headache two days. On the second day, v... Read more
Start with the normal sore arm continues on day five, normal headache two days. On the second day, very stomach pain so bad could not sleep now for three days.
58 2021-01-07 pain in extremity Vaccine injected too low, causing redness, warmth, swelling and pain at injection site.
58 2021-01-07 tingling Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling ton... Read more
Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling tongue and fingers; This is a spontaneous report from a contactable physician (patient). A 58-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 02Jan2021 at 09:45 at single dose in right arm for covid-19 immunisation. Medical history included hypertension, migraines. Concomitant medication included losartan 100mg/d, ergocalciferol (VIT D) 4000u/day, ascorbic acid (VIT C) 1000 /day. The patient experienced blotchy rash on chest, neck, shoulders and arms on 02Jan2021 at 10:05, mild tingling tongue and fingers in Jan2021. No urticarial lesions. Rash noted 20 minutes post injection. Took 25mg Benadryl and rash resolved. The outcome of the events was resolved in Jan2021. There was no other vaccine in four weeks. The patient was not diagnosed with COVID 19 prior vaccination, and was not tested for COVID 19 post vaccination. This case was reported as non-serious by reporter.
58 2021-01-08 numbness, tingling Facial tingling and numbness, left side of face (same side as shot). Lasted for several hours.
58 2021-01-08 tingling, feeling hot Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow.... Read more
Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow. At 5:34 pm when 15 min wait was done told staff what was happening. Was triaged by NP and MD on standby along w/EMT treated w/50 Benadryl/20 Pepcid/125 Solumedrol IVP. Waited in onsite Immediate Care and was given 1L 0.9 NS bolus. Transferred by ambulance to ER at 6:45 pm after experiencing tingling to chest and dizziness. Tingling changed to warmth in route to ER. Observed in ER and discharged home at 9 pm.
58 2021-01-08 tingling Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, mya... Read more
Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia Narrative: tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia
58 2021-01-09 weakness Pt experienced confusion, disorientation, dizziness, lightheadedness, weakness, & stiff neck followi... Read more
Pt experienced confusion, disorientation, dizziness, lightheadedness, weakness, & stiff neck following vaccination. Patient was sent home from work and symptoms persisted after rest.
58 2021-01-09 pain in extremity, feeling cold 10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, ba... Read more
10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, basically flu like symptoms. My skin hurt everywhere
58 2021-01-09 pain in extremity Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than ... Read more
Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than the first dose. Tired in evening so went to bed early. Around 2100pm chilling/fever began lasting about 5 hours. This was associated with headache, nausea, and arthralgias. No sleep. All day on 1/9/21 very lightheaded, headache, and some nausea. Spent the day lying on the couch. On 1/10/21 while headache still there in am, much improved. Still some uneasiness of stomach. L axillary soreness. Over all feel much better though not fully normal on afternoon of 1/10/21.
58 2021-01-10 facial paralysis, bell's palsy Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye an... Read more
Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye and nose on the right. Fatigue, cough
58 2021-01-10 pain in extremity, weakness, feeling cold tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head ... Read more
tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing. The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
58 2021-01-10 pain in extremity Patient refers developed general malaise, headache, feverish, joint pain, nausea and left arm pain
58 2021-01-10 tingling Patient experience pin needle sensation all over the body including arms, legs, hands and feet. Symp... Read more
Patient experience pin needle sensation all over the body including arms, legs, hands and feet. Symptoms started on 01/04/2021 is still present, however, patient admits to symptoms improving. Patient received medical care from primary care provider however they could not determine any causes and was advised to keep monitoring the symptoms.
58 2021-01-10 cold extremities Fatigue, muscle aches, mental fogginess, syncope, cold hands
58 2021-01-11 weakness, pain in extremity 1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headac... Read more
1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headache and R arm pain where vaccine was given.1000 mgs. Tylenol was taken, which offered very little relief. 1/8/2021; I awoke with extreme fatigue, unable to sit up, nausea, and diarrhea with stomach pain, headache, which wasn't unrelieved by 1000mgs of Tylenol, unable to raise R arm due to swelling and pain, aching and weakness all over body, joints, and muscles. It also caused a Fibromyalgia flare-up, which I wasn't experiencing prior to vaccine. It was 1/10/2021 before I was starting to feel better.
58 2021-01-11 burning sensation swelling and painful at injection site within first 24hrs in left arm. Red, itchy raised rash after ... Read more
swelling and painful at injection site within first 24hrs in left arm. Red, itchy raised rash after 7 days post injection that increased in area. Burning sensation experienced. Skin still discolored more than 20 days after 1st shot. 2nd dose in right arm: same reaction within 48hrs. redness, burning , itchiness sensation spreading to upper arm.
58 2021-01-11 discomfort, feeling hot About 12 hours after vaccination experienced chills, body aches, intermittent headache and general d... Read more
About 12 hours after vaccination experienced chills, body aches, intermittent headache and general discomfort. This lasted about 5-6 hours after which there was less aching but could tell that fever persisted, felt sluggish and warm. Temp was 99.9 at the highest over a 2-3 hour period. Ibuprofen was taken about 5 hours after the symptoms started, but only once. Late morning of 01/12 symptoms subsided and felt normal.
58 2021-01-11 hot flush CoughWheeze, Tachycardia, hot flashes, scratchy throat Narrative:
58 2021-01-11 numbness, discomfort, feeling hot, feeling of body temperature change immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really swe... Read more
immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease. She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck, back, and knees. She said the joint pain felt like "flu" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days. She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events "She clarified she had some injection site pain" "and the injection site was a little itchy" and Shoulder pain were recovered on an unspecified date, "Chills" and "feels shaky inside" were not recovered, "Joint pain" "Nausea" "Numbness facial" were recovering, while outcome of other events was unknown.
58 2021-01-11 numbness numbness of the lower extremities
58 2021-01-11 pain in extremity, weakness chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours... Read more
chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours; very sore arm which became worse overnight to the point she couldn't move her arm; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration at Left arm on 05Jan2021 14:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included covid-19 from 04Sep2020, Penicillin allergy. Concomitant medication in two weeks included lithium, sertraline, fish oil (OMEGA 3 FISH OILS), ergocalciferol (VIT D). There were no other vaccines administrated on same date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took metronidazole (FLAGYL) and experienced drug hypersensitivity, clindamycin and experienced drug hypersensitivity. On 05Jan2021 at 17:00, the patient experienced very sore arm which became worse overnight to the point she couldn't move her arm. On 06Jan2021 at 12 noon, she started to get the chills, body aches, fatigue, weakness and H/A. Temp was 99.4 and went up to 102.4 over the next 3 hours. The patient took ibuprofen (MOTRIN) 400mg at 3:30 AM with some effect. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
58 2021-01-11 pain in extremity Fever fatigue, chills, sore arm Narrative: Low grade fever. Rested, hydrated only, no OTC meds taken... Read more
Fever fatigue, chills, sore arm Narrative: Low grade fever. Rested, hydrated only, no OTC meds taken.
58 2021-01-11 pain in extremity Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with... Read more
Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with some effect. Felt OK otherwise until 12 noon on 1/6/21 when I suddenly felt chilled and not well. Temp went up quickly from 99.4 at 12 noon to 102.4 at 5PM. Temp 101.5 at 9PM. Had abdominal cramping, general body aches and muscle pains, H/A and left breast tenderness as if I was going to get my period (which I haven't had for 8 years). On 1/7/21 at 7AM temp- 99.7 and 98.8 at 11AM, but still felt tired, H/A, malaise, no appetite. Back to normal good health on 1/8/21 AM. Left arm was sore for 4 days.
58 2021-01-11 pain in extremity Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild... Read more
Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild headache, cotton headed, fatigue, left arm pain, neck/shoulder aches
58 2021-01-11 pain in extremity Severe Arm Pain; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old f... Read more
Severe Arm Pain; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular in the left arm on 17Dec2020 at 08:00 AM (at the age of 58-year-old) as a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, and asthma. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine, montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), vitamin B complex, magnesium, vitamin D3, and ascorbic acid (VIT C). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Dec2020 at 6:00 PM, the patient experienced severe arm pain within hours of the first injection. It was significantly reduced after a dose of Acetaminophen. The event was reported as non-serious. The clinical outcome of the event severe arm pain was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
58 2021-01-12 hot flush Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (pat... Read more
Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (patient recovered before leaving for ER, only sent due to past cardiovascular events)
58 2021-01-12 pain in extremity Chills, Headache, Feeling Unwell, Sore Arm
58 2021-01-12 pain in extremity arm discomfort and mild headache
58 2021-01-12 pain in extremity fatigue; patient received the second dose in less than 21 days from the first dose; tenderness in t... Read more
fatigue; patient received the second dose in less than 21 days from the first dose; tenderness in the arm; This is a spontaneous report from contactable nurse, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the left arm on 04Jan2021 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, and asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), vitamin B complex (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), and multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 on 17Dec2020 at 08:00 (Lot Number: EK5730; at the age of 58-years-old) for COVID-19 immunization in the left arm and experienced severe arm pain. The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first vaccination). On 04Jan2021, the patient had tenderness in the arm. The patient took acetaminophen (MANUFACTURER UNKNOWN) which helped. On 05Jan2021, the patient experienced fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the tenderness in the arm and fatigue were recovered on unknown dates in Jan2021.
58 2021-01-12 tingling, burning sensation Patient reports tingling and burning sensation at the tips of her right fingers.
58 2021-01-13 feeling hot, burning sensation Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lighthead... Read more
Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lightheadedness and elevated blood pressure of 210/110. BP down to 170/100 at the time of leaving appointment (20 minutes after shot). The next day she felt nausea, Ha, body aches and burning sensation down the arm of the injection.
58 2021-01-13 pain in extremity Body Aches, Headache, Sore Arm, Diarrhea
58 2021-01-13 pain in extremity Arm soreness, headache , body aches, dizzy, ears ringing
58 2021-01-14 feeling hot reported symptoms of one wave of nausea (which quickly resolved) and a warm pulsing sensation to her... Read more
reported symptoms of one wave of nausea (which quickly resolved) and a warm pulsing sensation to her left posterior hand from wrist distally to index finger.
58 2021-01-14 pain in extremity Within 10-12 hours after vaccine administration, Pain/burning in left arm and severe body/muscle ach... Read more
Within 10-12 hours after vaccine administration, Pain/burning in left arm and severe body/muscle aches (8/10 on pain scale). Headache (4/10). Fatigue. Temperature 100.1. Took Ibuprofen and Tylenol 1st through 5th day. Temperature was under 99.0 by 4th day. Above side effects were bearable with Ibuprofen by 4th day and only arm soreness by 5th day. **Of note, I was diagnosed with COVID on September 11, 2020 and had since recovered.
58 2021-01-14 pain in extremity Right arm became painful and could not touch or move without lots of pain; Muscle pain; Pain; very a... Read more
Right arm became painful and could not touch or move without lots of pain; Muscle pain; Pain; very achy all over; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in right arm, on 07Jan2021 at 10:00, at a single dose, COVID-19 immunization. The patient's medical history included hypertension (HTN), exercise induced asthma, allergies to sulfa, and hormones. The patient's concomitant medications included lisinopril, carvedilol (COREG), acetylsalicylic acid (ASA), levothyroxine sodium (SYNTHROID), and unspecified hormones. The patient previously took the first dose of BNT162B2 on 16Dec2020 (also reported as 20Dec2020) at 2:00 PM for COVID-19 immunization (intramuscular in left arm; Lot Number: EK5730). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 07Jan2021 at 10 PM (also reported as 7 hours after shot), the patient's right arm became painful and could not touch or move without lots of pain. 1 hour later, the patient went to bed, only to be woken with excruciating muscle pain all over. The patient was unable to lie down, sit, stand, or move without severe pain. The patient took ibuprofen (MOTRIN) and applied heat and lied down on stomach. Within 4 hours, that pain decreased, and the next 24 hours was very achy all over. The patient used heat most of the day. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
58 2021-01-14 pain in extremity Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever... Read more
Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever; nausea; This is a spontaneous report from a contactable Other HCP reported for herself (patient). This 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via an unspecified route of administration from 07Jan2021 at 15:45 at single dose on left arm for COVID-19 immunisation. Medical history included COVID-19 and was sick for 17 days, no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. The patient experienced left arm pain from shoulder to elbow, extreme fatigue, headache, joint pain, chills, low grade fever, nausea on 07Jan2021 at 21:00. Symptoms started five hours after injection and did not abate until about 64 hours after vaccination. No treatment was received for the events and all considered as non-serious. The outcome of the events was recovered in Jan2021.
58 2021-01-14 tingling Patient c/o tingling in hands a few minutes after vaccine. Was found to be hyperventilating. No airw... Read more
Patient c/o tingling in hands a few minutes after vaccine. Was found to be hyperventilating. No airway compromise, SOB, CP, or dizziness. Transported to ED from vaccine clinic.
58 2021-01-14 tingling Diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little... Read more
Diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little) face; This is a spontaneous report from a contactable other HCP. A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration in left arm on 29Dec2020 11:00 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included Scleroderma, Interstitial Lung Disease, and Raynaud's. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tadalafil (ADCIRCA), amlodipine, pentoxifylline, ASA, and fish oil. The patient experienced diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little) face that started around 03Jan2021 and was at its worst on 04Jan2021. The patient went to the doctor's office on 05Jan2021. The outcome of the event was recovering. The event was assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events.
58 2021-01-15 numbness Chills,fever,almost fainting,numbness in hands ,arms,shins,hyperventilating. Symptoms started the ni... Read more
Chills,fever,almost fainting,numbness in hands ,arms,shins,hyperventilating. Symptoms started the night of the vaccine. Went by ambulance to ED
58 2021-01-17 burning sensation Rec'd 1st dose on 1/9/2021 in the morning. By Sunday afternoon, face started burning and itching. on... Read more
Rec'd 1st dose on 1/9/2021 in the morning. By Sunday afternoon, face started burning and itching. on 1/11/2021 was seen in the ED for bilateral eye swelling, right side greater than left.
58 2021-01-17 feeling cold 1/17/21 Received dose at 0800. Fever started at 2330. Fever started at 100 then progressed to 103. ... Read more
1/17/21 Received dose at 0800. Fever started at 2330. Fever started at 100 then progressed to 103. Also had muscle aches, joint pain, feeling chilled, and severe headache. Took ibuprofen at 0300 1/18/21. Followed by Tylenol and Motrin (alternating). Headache still ongoing. Aches and chills subsiding as of 1500 1/18/21. Temperature still 100.
58 2021-01-17 muscle spasms, pain in extremity Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour afte... Read more
Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour after vaccine, felt fatigued the day of the vaccine for about an hour after, On 1/14 at 0530 woke up with a horrible right calf cramp was relieved by massage. Sat at side of bed began feeling extremely nauseated, diaphoretic then syncopal episode that lasted approximately 5 seconds.
58 2021-01-17 pain in extremity ARM PAIN, FEVER 101, JOINT PAIN FOR 24 HRS. TOOK TYLENOL 500MG 2 TABLETS
58 2021-01-17 tremor, pain in extremity LEG PAIN,CHILLS,WEAKNESS IN LEGS,SHAKING,HEADACHE,DIZZINESS AND FATIGUE 24 HOURS FOLLOWING INJECTION
58 2021-01-18 weakness Fever, chills, weakness, exhaustion lasting approximately 32 hours.
58 2021-01-18 weakness Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath,... Read more
Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath, itching, severe chills alternating with fever, chest pain, facial nerve numbness, blurry vision, sore throat, nausea, diarrhea. Treatment was a Medrol Dose pack for 6 days. Outcome was severe symptoms decreased after 4 hours of taking first dose (6 tabs) of prednisone. As the prednisone dose decreases each day there is increased muscle pain and shortness of breath/lung tightness with activity, and severe fatigue
58 2021-01-18 depressed level of consciousness The evening of receiving the vaccine every muscle and joint in my body was achy, started feeling anx... Read more
The evening of receiving the vaccine every muscle and joint in my body was achy, started feeling anxious and depressed, just to the point that I could not leave my bed for a week, extreme fatigued. I feel a little better, started making myself get up and do stuff and went back to work on 01/11/2021.
58 2021-01-18 migraine Nauseous, extremely sore and aching muscles and body, migraine
58 2021-01-18 muscle spasms, pain in extremity Day 10 post number 2 vaccine. Muscle aches, cramping and pain in lateral back and legs.
58 2021-01-18 pain in extremity I had a sore arm right away. The next morning I felt like I could have a fever and had body aches an... Read more
I had a sore arm right away. The next morning I felt like I could have a fever and had body aches and did not feel good. When I got to work I talk to Dr. and he gave me a shot of Depomedrol and Solunedrol shot.. The shot helped for a while but starting feeling worse, I took a second dose of Advil. I woke up the next morning with a head ache and body ache, I stayed home from work. I rested all day and by that evening I felt all better.
58 2021-01-18 pain in extremity I started feeling tired the day after my injections (day 2) and didn't think much of it until i got ... Read more
I started feeling tired the day after my injections (day 2) and didn't think much of it until i got home around 6:00 pm and i was exhausted. I couldn't even open my eyes without putting effort into it. By the next morning (day 3) i was extremely tired and it hurt in my leg muscles, butt muscles, arms and stomach. I woke up at 2:30 PM and threw up. The next day (day 4) i had diarrhea and was still exhausted and just felt lousy. Today is day 7 and i finally came back to work. I still have a slight headache and nausea and stomach cramping on/off.
58 2021-01-18 tingling, pain in extremity Finger tips on right hand tingling and painful. Slightly inflamed and swollen. Just monitored for im... Read more
Finger tips on right hand tingling and painful. Slightly inflamed and swollen. Just monitored for improvement.
58 2021-01-18 cold extremities Severe Head/Neck ache Body Aches Fever (101 - 102) Hard Chills Nausea All Fingers were cold to the ... Read more
Severe Head/Neck ache Body Aches Fever (101 - 102) Hard Chills Nausea All Fingers were cold to the touch and severely aching (felt as though they were frost bitten) Fatigue
58 2021-01-19 burning sensation 1:55 sitting in chair in observation area, began feeling a "burning" sensation in her arms. 2:06 mo... Read more
1:55 sitting in chair in observation area, began feeling a "burning" sensation in her arms. 2:06 moved via w/c to private observation with EMT on site in Gave patient ice packs for both arms. States that the ice reliefs to burning. attendance. HR 78; O2 97%. Unable to obtain BP due to obesity. Per exam noted on Left lower arm a solid red raised area about 3 inches in diameter about 1/8 cm height. States it burns. Has mildly red scattered hive like areas on right lower arm. 2:15 Gave patient ice packs for both arms. States that the ice reliefs to burning.. Denies any burning or swelling in throat. BBS CTA per EMT assessment. No shortness of breath note; 2:25 States she drove on her own and lives in a senior adult complex. EMT recommended ambulance for further evaluation. Patient declined. EMT instructed patient to contact medical physician or emergency if problems persist or if symptoms worsen. Patient agreed and left ambulatory to private vehicle.
58 2021-01-19 burning sensation Approximately 1.5 hours after receiving the vaccine, she noticed redness on her arms, upper chest an... Read more
Approximately 1.5 hours after receiving the vaccine, she noticed redness on her arms, upper chest and back of her neck which was mildly itchy and burning. She took Benedryl 25 mg prior to the vaccine and 25 mg after the symptoms appeared. Symptoms resolved within about 24 hours.
58 2021-01-19 discomfort Left Axcillary pain and swelling with, moderate lymph node tenderness. Pain Grade 7/10. Discomfort d... Read more
Left Axcillary pain and swelling with, moderate lymph node tenderness. Pain Grade 7/10. Discomfort developed during the late night following injection.
58 2021-01-19 feeling cold, tingling Left side facial tingling and perception of face feeling cold. Occurred approximately 20-25 minutes ... Read more
Left side facial tingling and perception of face feeling cold. Occurred approximately 20-25 minutes after receiving vaccine and lasted 45-60 minutes.
58 2021-01-19 pain in extremity On Tues, 1/12 I started feeling like I was getting a cold because I got the chills when I got home,... Read more
On Tues, 1/12 I started feeling like I was getting a cold because I got the chills when I got home, but not the flu because I had my flu shot in Oct.2020 Wednesday 1/13 I left work because I started with vomiting, diarhhea , a light headache and my arm was real sore. That continued on through that night and into the next morning. So I had to call in at work that morning 1/14. I finally started feeling better by friday night, 1/15. The headache was gone and the chills were only slight and I could finally keep some toast down. Before that I could only slightly keep liquids down.
58 2021-01-19 seizure like phenomena Chills, seizure like activity, body aches, injection site soreness
58 2021-01-19 tenderness 1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21... Read more
1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21 started to have shortness of breath and made a doctor's appointment for 1/13/21. Seen by provider on 1/13/21 and was sent to ED and admitted to the hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery. Transferred to another acute care hospital for removal of thrombosis. Patient started on Eliqus and no intervention for removal of the thrombosis.
58 2021-01-19 unresponsive to stimuli I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet w... Read more
I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive.; I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day; I woke up at midnight and felt extreme malaise; I was covered in sweat; vomited; I checked my temp and it was 99.7°F; sore; I think I had either a seizure or a vasovagal response.; This is a spontaneous report from a contactable nurse (patient). This 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular at single dose in the left arm on 09Jan2021 06:00 for Covid-19 immunisation. Medical history included atrial fibrillation on unknown date (1 episode), allergic to Keflex. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular in the left arm on 22Dec2020 for Covid-19 immunisation. On 10Jan2021 01:00 AM, the patient experienced: I began to pass out and yelled for my husband, he said when he came in i was sitting on the toilet with my head back, eyes rolling back not responsive (loss of consciousness) (medically significant), I had my 2nd vaccine at work early sat the 9th and felt increasingly worse all day (feeling abnormal), Iwoke up at midnight and felt extreme malaise (malaise), I was covered in sweat (hyperhidrosis), vomited (vomiting), I checked my temp and it was 99.7°F (pyrexia), sore (pain), I think I had either a seizure or a vasovagal response (seizure). No treatment required. The outcome of the events was recovered. The events were described as follows: I am healthy RN with no active medical problems. I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day, I expected this so was not alarmed and went to bed around 10pm. I woke up at midnight and felt extreme malaise and went to the bathroom in case I might vomit, etc. and I tried to have a BM. I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive. He yelled at me for about 10 seconds and I came to, I was covered in sweat. I asked him to walk me back to the bedroom where I again passed out, fell to the floor and hit the bed, then was unresponsive again for about 10 seconds then came to again and vomited. After this I felt completely relieved of my malaise. I checked my temp and it was 99.7°F. After this I was sore but otherwise completely okay, the next day I had a temp of 99.5°F. Today I am back to normal. I think I had either a seizure or a vasovagal response. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event "began to pass out" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-01-20 numbness, pain in extremity Day 1-1/11/21-Vaccine provided, employee started having nausea at about 7:00 pm with, left arm pain ... Read more
Day 1-1/11/21-Vaccine provided, employee started having nausea at about 7:00 pm with, left arm pain and left side body pain and numbness down to foot, fever 99-100, diarrhea, joint soreness and stomach cramping. Day 2-1/12/21-diarrhea, headache, heavy feeling on left side of body, left arm soreness with limited ROM in left arm. Day 3-1/13/21-mild diarrhea only, Day 4-1/14/21-no symptoms, nothing.
58 2021-01-20 numbness I had the shot in my left arm. Stayed for about 10 minutes and headed out. I told my coworker my ton... Read more
I had the shot in my left arm. Stayed for about 10 minutes and headed out. I told my coworker my tongue felt like it was a little swollen. A little later on I felt like something was on my neck so I reached up felt some swelling on my lower neck and shoulder. Before reaching back to work my face felt like it was swelling only on the left side. As the day went by the workers at my school could tell that my face was swelling. Got home called the hospital and the told me to go to the ER. I went and they checked me out and put me on prednisone and benadryl. Second day I still feel like my face feels numb and still have to swelling at the bottom of my neck.
58 2021-01-20 migraine Dose 1: I had a high fever (101.6), serve body ache and migraines this lasted for about 2 1/2 days. ... Read more
Dose 1: I had a high fever (101.6), serve body ache and migraines this lasted for about 2 1/2 days. This caused me not to drive Dose 2: Fever 102-104 took Tylenol , body ache and bad migraine
58 2021-01-20 pain in extremity, numbness Da of Vaccine-1/11/21-at about 7:00 pm in the evening employee started having nausea, left arm (vacc... Read more
Da of Vaccine-1/11/21-at about 7:00 pm in the evening employee started having nausea, left arm (vaccine arm) pain, all left side pain and numbness down to left foot, fever 99-100, diarrhea, joint soreness, stomach cramps. Day 2-1/12/21-headache, diarrhea, left side all felt heavy, left arm remained sore and limited ROM in left arm. Day 3-1/13/21-Mild diarrhea only and on Day 4 1/14/21-nothing, all symptoms gone.
58 2021-01-20 pain in extremity DEVELOPED LUMP IN RIGHT ARMPIT AND PAIN IN RIGHT ARM MORNING AFTER INJECTION
58 2021-01-20 tingling Systemic: tingling in legs, chills-Mild
58 2021-01-20 tremor I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe/when my throa... Read more
I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe/when my throat get bad; I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe; I started hyperventilating because I was scared; I started hyperventilating because I was scared; I felt strange but not sick or anything like that, it hit me like with a ton of bricks; I was shaking so bad I couldn't even hold anything; I was aching all the way from head to toe; I got my first Pfizer BioNTech COVID 19 Vaccine on 22Dec/And then I had my second one on 08Jan; I have residual like I am sill aching in my back; I tasted the food, it tasted funny, like not the same but then at the end of the day I could taste food like normally; I had sort of a cough but not like I urge to cough but it was not like chronic; Muscle soreness; still tired; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old female patient received the second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on right deltoid on 08Jan2021 08:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on left deltoid on 22Dec2020 at single dose for covid-19 immunisation. The patient stated she got her first Pfizer BioNTech COVID 19 Vaccine on 22Dec2020 and had no issues really with that one. And then she had second one on 08Jan2021. The first she got in her left deltoid and the second one she had on 08Jan2021, she had in her right deltoid. It's towards 8:30 in the morning roughly is when she had it. So, during the day went on 08Jan2021, she felt strange but not sick or anything like that. And the day went on to eat something and then came home. And then she'd say at around 7:30 it hit her like with a ton of bricks. She was shaking so bad, she couldn't even hold anything. And then she was aching all the way from head to toe. And she was like she will get her tooth brush at least. So, she brushed her teeth and then all of a sudden her throat closed up on 08Jan2021 around 7:30 pm and she couldn't breathe. And she stated she was like "oh my gosh and then it sort of opened up enough for me to scream for my husband, I yell for him to come and then it did it again, it closed up again. And when he came, I started hyperventilating because I was scared. And he calmed me down and rub my back and everything, and it went away. But it scared me. But the shaking lasted probably all through night maybe till 3 in the morning because I tried not to take anything and I probably took 2 Advil. And now I have residual like I am sill aching in my back. And it's weird, in morning I tasted the food, it tasted funny, like not the same but then at the end of the day I could taste food like normally. And then I had sort of a cough but not like I urge to cough but it was not like chronic. Not a lot but it's there like if you urge to cough, it doesn't happen a lot. " The patient stated "It started on 08Jan2021 around 7:30 pm, when my throat get bad. I have muscle soreness specially in my back and I don't know in the taste in the morning the food doesn't taste right but then like it's fine towards the afternoon. And I am still tired and a slight like cough. But the cough isn't really anything, if I get urge to cough. It's not all day, it's not chronic at all." The patient started to took Advil as a treatment and stated "Well I started to because it was like 3:30 in the morning, or 2 or 3 in the morning I did take 2 Advil. And they helped with that pain." The outcome of the event taste abnormality was recovered, outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
58 2021-01-20 tremor Nausea, headache, chills, sweats, swelling to the tongue, SOB, loss of appetite, shakiness,
58 2021-01-21 migraine Sick to stomach, migraine head ache
58 2021-01-21 pain in extremity On 1/20 21 2nd injection around 10:00am sore left arm. around 2:45pm right eye slightly swollen ... Read more
On 1/20 21 2nd injection around 10:00am sore left arm. around 2:45pm right eye slightly swollen - slight headache. On 1/21 3:45am right eye swollen, (but not swollen shut) a little ache -slight headache.
58 2021-01-21 tingling, numbness Post-Vaccination Paresthesia course: About Sunday, 1/17/2021, I began to feel a numbing sensation s... Read more
Post-Vaccination Paresthesia course: About Sunday, 1/17/2021, I began to feel a numbing sensation spreading on the top of my head. Since I was recovering from a severe allergic reaction to the Covid vaccine (numb, swollen lips, face, tongue), I initially thought it may be a recurrence. However, by the morning of Tuesday, 1/19/2021, the numbness was complete from the tops of my eyebrows, over my scalp, my ears and down the center of my back to my buttocks. The numbness was bilateral. Alarmed, I went to the Emergency Room. (I am a hospital pharmacist there.) The ER consulted Neurologist. After MRI results, diagnosis was Post-Vaccination Paresthesia. I was released from work by the ER through 1/21/2021. The height of the paresthesia was 1/21/2021. This included some auditory buzzing and mild blurred vision. Today, 1/22/2021, I am beginning to regain feeling on my back and forehead. I estimate that I have regained about 50% feeling on my scalp.
58 2021-01-21 paralysis Systemic: Patient experienced temporary paralysis from the shoulders down lasting approximately 20 m... Read more
Systemic: Patient experienced temporary paralysis from the shoulders down lasting approximately 20 minutes-Severe
58 2021-01-24 weakness 24 hours post vaccine developed heavy fatigue, chills, body aches, headache, and weakness for 8 hour... Read more
24 hours post vaccine developed heavy fatigue, chills, body aches, headache, and weakness for 8 hours, then slight headache and weakness continued an additional 12 hours.
58 2021-01-24 pain in extremity On the second day on 12/29/2020 in the afternoon I started feeling fatigue, I hade nose bleeding, fe... Read more
On the second day on 12/29/2020 in the afternoon I started feeling fatigue, I hade nose bleeding, fevers & headaches. On the third day on 12/30/2020 I had hives I had them in my face they were the size of a dime they are lumping I had them on my eyebrows & on my right cheek, & continued nose bleeding, fever continued, fatigue continued, headaches continued, pain on my arm & I felt with no energy. I had a lot of nose bleeding. On 12/30/2020 I called the doctor and they gave me an appointment for 12/31/2020 & they gave me a zoom meeting. The doctor said every symptom I had was a normal reaction to the covid vaccine except the nose bleeding. The symptoms continued but the nose bleeding is the only thing it has stopped.
58 2021-01-25 weakness, cold sweat This is a spontaneous report from a contactable consumer. A 58-year-old female patient received firs... Read more
This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication included metformin from 2012 and ongoing for diabetes. The patient stated on 21Dec2021 "I received my first dose of the COVID-19 vaccine, I was supposed to get the second dose yesterday, I couldn't go because I am home sick on 10Jan2021, I don't know if I have COVID or not." Her job gave it to her. She started having chills yesterday on 11Jan2021. On 11Jan2021, it was reported that he has hot and cold sweats, she has body aches and a slight headache. She is weak. She is frequently urinating every hour. She has a light headache. Her body feels weird like she cannot stand because she is really weak. She is in pain. She was supposed to get the second dose 11Jan2021. She took the vaccine for her safety. The outcome of the event sick was unknown, while not recovered for the other events.
58 2021-01-25 nerve pain Nerve pain on her back. It is in the same spot where she had previously had shingles pain
58 2021-01-25 throat numbness tingling / burning sensation in throat about ~12 minutes after vaccine. Did not progress to airway c... Read more
tingling / burning sensation in throat about ~12 minutes after vaccine. Did not progress to airway compromise. Sensation changed to a numbness but did not worsen. Patient given Benadryl and Pepcid, monitored. Improvement in symptoms noted, discharged home.
58 2021-01-26 migraine Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date ... Read more
Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date vaccine date on 04Jan2021; Day 6 -10 migraines hit; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 23:30 on 04Jan2021 at single dose for COVID-19 immunization and other vaccine same date vaccine date on 04Jan2021 on left arm. Medical history included allergies to penicillin, allergy to bananas, wheat (patient do eat products w wheat), dairy; Melanoma 3rd degree 1987 & 2005, allergies, sinus surgery resolved problems. Concomitant medication included venlafaxine, omeprazole, bupropion hydrochloride (WELLBUTRIN). It was reported that patient had no other vaccine in four weeks. The patient previously took ampicillin and experienced drug allergy. No issues until middle of night of first injection. The patient experienced intense pain in left injection arm; fever; could not sleep, other aches all over on 05Jan2021. Used ice packs & Motrin. Fever left after two days. Intense pain continued. 5th day switched to heating pad & took 2 tablets of Tylenol every 6 hours. Called patient's doctor on days 6 & 8. Suggested patient alternate Tylenol & Motrin every 6 or 8 hours. Day 6 -10 migraines hit. The outcome of event fever was recovered on 07Jan2021. The outcome of events migraine and Product use for unapproved combination was unknown. The outcome of rest events was not recovered. Information on the LOT/Batch number has been requested.
58 2021-01-26 tenderness Large uncomfortable lymphadenopathy in L neck/clavicle area, the size of a lemon. It hurt to move m... Read more
Large uncomfortable lymphadenopathy in L neck/clavicle area, the size of a lemon. It hurt to move my neck, and is very tender to touch. It is still present now, 10 days after receiving the vaccination. I saw my MD today who assured me it is a typical appearance for a lymphadenopathy, but it still bothers me, especially never having had such an occurrence before.
58 2021-01-26 tremor 15 minutes after her second dose of the injection, patient reported ringing in both ears. Very loud... Read more
15 minutes after her second dose of the injection, patient reported ringing in both ears. Very loud. She also reports her parkinson symptoms are increasing. Shaking of arms and legs were observed. Patient also reported nausea.
58 2021-01-27 weakness, pain in extremity Sore right arm within one hour of receiving vaccine. Headache developed later in day. Not really con... Read more
Sore right arm within one hour of receiving vaccine. Headache developed later in day. Not really concerned as were told this was normal. Arm soreness improvid within 2 days. However, it has now been 9 days and I wake up with a throbbing severe frontal headache every day. I have periods of extreme fatigue; I suddenly feel like I no longer have the strength to stand. i sit or lay for 20 minutes or so to recover my strength. I have rarely had headaches in my life only with strep throat infections and a couple of sinus infections. So this is very unusual for me. I am afraid to take the second dose if the first caused this severe of a reaction.
58 2021-01-27 weakness Weak Dizzy sleepy pain at injection site feels like she is going to get the flu
58 2021-01-27 feeling cold, pain in extremity Arm was very sore. Felt nausea and very frigid for hours with a slight headache starting late in th... Read more
Arm was very sore. Felt nausea and very frigid for hours with a slight headache starting late in the afternoon after vaccine administered. By next morning still had a slight headache and tired. Within 36 hours felt much better.
58 2021-01-27 flushing IMMEDIATELY DEVELOPED FLUSHING, NAUSEA AND DIZZINESS.
58 2021-01-27 pain in extremity The night of injection; woke up several times once with pain in the arm from neck to elbow; diaphore... Read more
The night of injection; woke up several times once with pain in the arm from neck to elbow; diaphoretic, pain to entire right side; right side teeth and jaw pain; general malaise. I took 2 -650mg Tylenol before bed. Pain in the right arm from neck to elbow lasted for 1 week, used 2-650mg Tylenol to tx
58 2021-01-27 pain in extremity 1st dose just sore arm mild headaches, body aches lasted 2 - 3 days. 2nd dose had not in arm, sore ... Read more
1st dose just sore arm mild headaches, body aches lasted 2 - 3 days. 2nd dose had not in arm, sore arm hot for about a week, mild headaches, body aches, diarrhea, chills out of breathe, fatigue - but no temp. This has being going on and off for last 2 weeks. Just had diarrhea on 1/25/21 again with chills, fatigue, little out of breathe, mild headache. 1/28/21 went back to work with chills, mild headache, out of breathe but no temp. 97.1 this morning.
58 2021-01-27 seizure on Jan 20th, I took my dogs to their grooming appt and stopped at store for a few things. I woke up... Read more
on Jan 20th, I took my dogs to their grooming appt and stopped at store for a few things. I woke up in store to EMS putting me in ambulance. I asked them what was going on and they said I had a seizure. I had no pre-warning, hit head, right shoulder, and bit lip. EMS took me to Emergency Department. Had labs and head CT, all normal. MD felt seizure was due to vaccine.
58 2021-01-27 tremor, flushing It's an idiosyncratic reaction that happens periodically; flushing; palpitations; shaking chills (vi... Read more
It's an idiosyncratic reaction that happens periodically; flushing; palpitations; shaking chills (violent shaking); difficulty breathing; This is a spontaneous report from a contactable pharmacist. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EL3246; expiration date not provided), via an unspecified route of administration on 12Jan2021 16:30 at a single dose at left arm for COVID-19 immunisation, glatiramer acetate (COPAXONE), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for unspecified indication. Medical history included multiple sclerosis, hypothyroidism and osteoporosis. The patient was not pregnant. The patient received the first dose of BNT162B2 (lot number: EKS730) on 22Dec2020. The evening after the patient had her second Covid vaccine, the patient gave herself Copaxone shot. On 14Jan2021, the patient stated that there was an idiosyncratic reaction that happens periodically. Symptoms were flushing and palpitations. It ends quickly. About 15 minutes after that occurred, the patient had shaking chills (violent shaking) and difficulty breathing. The symptoms lasted about 1 hour. During that hour, the patient had someone drive her to the hospital but during the drive the symptoms calmed down. The patient spoke with one of the nurses that does screening in the lobby and they said many people had been reacting to their second shots, so she didn't really need to be seen in the ED since her symptoms had resolved. No treatment was received. The action taken in response to the event for glatiramer acetate was unknown. The outcome of the events was recovered on an unspecified date.
58 2021-01-28 weakness After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, ... Read more
After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, and shedding an excessive amount when brushing. She started noticing this about 1-2 weeks after her first vaccine, and it got worse after the second vaccine on 1/7/21 (Pfizer Lot#EK9231). It is an even thinning, no patches of hair loss. She was diagnosed with COVID on 10/7/20 which resulted in hospitalization. Reporting fatigue, continued loss of sense of taste and smell, decreased appetite, and hair loss. Experiencing fatigue and decreased energy, worse in the evening, falls asleep easily when she gets home after work, started when she got COVID.
58 2021-01-28 weakness Left sided weakness, headache, chills, hypertension (normally hypotensive), bradycardia.
58 2021-01-28 difficulty speaking Within 4 hours of vaccine, I had fatigue. By the next morning, I developed fever. Sublingual temp u... Read more
Within 4 hours of vaccine, I had fatigue. By the next morning, I developed fever. Sublingual temp up to 100.8 but also had chills. I had fever, fatigue, chills, and myalgia that peaked at 33 hours post vaccination. I took multiple doses of 600mg - 800 mg ibuprofen. By 41 hours post vaccination, symptoms had resolved completely. Dose 1 Dec 23, 2020, Lot EH 9899 Laryngitis like illness (cough, phlegm at larynx, hoarse voice) December 29,30, 2020 resolved. + Covid PCR on Jan1, 2021 (frontal headache, fatigue, fever) Delayed dose two until January 27, 2020 I am a pediatrician and I work in an Urgent Care with Covid positive patients. This report is for your tracking purposes. I would have considered seeing a PCP if I were not a physician.
58 2021-01-28 flushing flushing, redness, right hand sign of face, ear and right arm 45 minutes post vaccine; took Benadryl... Read more
flushing, redness, right hand sign of face, ear and right arm 45 minutes post vaccine; took Benadryl; over the course of time, no worsening of symptoms; pt took another Benadryl on advice of visiting nurse about 4 hours after 1st dose
58 2021-01-28 migraine Arm pain at injection sight 6 hours later along with swollen glands. Four days later a migraine hit... Read more
Arm pain at injection sight 6 hours later along with swollen glands. Four days later a migraine hit around 2:00 pm and lasted at least 12 hours. Also swollen shoulders and shoulder and back pain. The following week I experienced sudden shortness of breath that last for approximately 10 minutes while I was at work with profuse sweating on my lower back. The shortness of breath occurred agin the next day while working around the home. and lasted about 5 minutes.
58 2021-01-28 pain in extremity 2 to 3 hours after the shot was given the area around where the shot was given was extremely sore (l... Read more
2 to 3 hours after the shot was given the area around where the shot was given was extremely sore (level 9). I began taking Tylenol which caused the pain to subside to a reasonable level. I took Tylenol every 6 hours to keep the pain in my arm, which seemed to cause some neck stiffness, down to a 2 or 3 level (10 being the worst pain). The next morning pain was down to 1 or 2 level, I took Tylenol again. By noon the second day pain was gone.
58 2021-01-28 tingling Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat... Read more
Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat; Dizziness; difficulty breathing; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142, expiry: Mar2021), via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and no concomitant medications as the patient reported she was healthy. The patient experienced severe reactions, she was in the hospital twice. On 10Jan2021, the patient experienced difficulty breathing, severe fast heartbeat and dizziness. On 13Jan2021, patient had headache, chills, not feeling well, and tingling all over her arms, face and legs. The patient further stated that a week after getting the vaccine, last Sunday, she had a severe reaction and was hospitalized twice due to the events. Exactly one week after receiving the vaccine, on Sunday 10Jan2021, patient ended up in an ambulance due to dizziness, fast heart rate, and difficulty breathing which all started on 10Jan2021. She confirms that she was admitted to the hospital that day, and she was discharged the next day, on 11Jan2021 in the afternoon. On 13Jan2021, in the afternoon, the other symptoms of headache, chills, not feeling well, and tingling all over her arms, face and legs, started. Patient went back to a different hospital, to the emergency room, on Wednesday 13Jan2021, but was not admitted at that time. Patient mentioned the difficulty breathing was okay, but she does not want to say it was 100% better because she was still having a little bit of difficulty. Caller states that the dizziness and fast heart rate are still pretty serious. It was reported that the patient was hospitalized for the event fast heart rate from 10Jan2021 to 15Jan2021, and chills, not feeling well, and tingling all over her arms, face and legs on unspecified date. Patient was due to get the second dose on 24Jan2021, and she does not know if she should because she had side effects to the first dose. Patient seen several doctors and she had a cardiologist that was monitoring her, and she has had a stress test and labs and those are all normal. patient confirms that the product was no specifically prescribed to her, but it was given via workplace policy as she works for a hospital. The outcome of the events difficulty breathing was recovering and not recovered for all the other events. No follow-up attempts are possible; information about batch number has been obtained.
58 2021-01-28 speech disorder, flushing Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the... Read more
Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the top of her head felt funny. At this point on site ARNP was called over to Patient. and both myself and ARNP noticed flushing on face and neck and hives on neck area. On site EMS notified and came over. Patient then self medicated with 2-25 mg Benadryl. Patient exhibited mild cognitive slowing with some mild speech and thought degradation...felt funny....not sure what she felt.... Physical symptoms noted above showed some mild sign of improvement? Clinicians insisted that patient should be taken to hospital of choice via ambulance. Patient was taken to clinic where she was under observation, put on IV saline and administered IV steroid, dexamethasone. After approximately two hours patient was released and instructed to take over-the-counter Benadryl every six hours for six days and one Pepcid per day for six days.
58 2021-01-29 fibromyalgia, weakness Experienced the typical symptoms described on fact sheet, fever, chills, tiredness, headache, inject... Read more
Experienced the typical symptoms described on fact sheet, fever, chills, tiredness, headache, injection site soreness, and body aches. My body aches were severe and I had severe episode of my fibromyalgia symptoms to reoccur. I was totally wiped out for a full day (literally stayed in bed) my arms and legs were heavy and hard for me to lift so I was extremely weak; and thus far for today I am still not 100% as the pain is still very noticeable and I?m totally exhausted. Fibromyalgia symptoms are still present and just don?t feel well at all.
58 2021-01-29 pain in extremity sore arm, fever up to 102, chills, body aches and pains, severe nausea, vomited x1, stomach cramps, ... Read more
sore arm, fever up to 102, chills, body aches and pains, severe nausea, vomited x1, stomach cramps, diarrhea x2 - total severe symptoms lasted about 24 hours, but total symptoms lasted 60 hours
58 2021-01-30 weakness The nxt morning of vaccination on 1/9/2021 when I woke up I started feeling leg muscle pain, ankle p... Read more
The nxt morning of vaccination on 1/9/2021 when I woke up I started feeling leg muscle pain, ankle pain, I felt very very tired, very weak I could not due my normal activities, I also had a headache & chills. The first 2 days where the worst I could not do anything but all the symptoms lasted about a week.
58 2021-01-30 involuntary muscle movements, weakness Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immedia... Read more
Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immediately after injection. They sent me to doc on site and applied ice. After 29 minutes symptoms started to subside. By the evening pain moved across back of shoulders blades. Increased headache with chills and alternating fever. Could not sleep due to pain. Next morning,today. Had abdominal pain cramping and diarrhea. Unable to sit up or walk much due to weakness and feel will pass out.
58 2021-01-30 unresponsive to stimuli After being observed for approximately 20 minutes and patient walked to her car without assistance I... Read more
After being observed for approximately 20 minutes and patient walked to her car without assistance I was called to assess the patient in the parking lot for troubles breathing. EMS was called as I made my way outside. Upon my arrival patient was leaning out of the car and stating that she could not breath. She was able to tell me that she was allergic to penicillin. Oxygen was immediately placed on the patient with minimal relief. Lung sounds were coarse throughout. She then began to vomit about every 20-30 seconds. Epipen was administered in the right leg with no relief. Patient continued to complain of troubles breathing and vomiting. A second epipen was administered in the patients right arm again with no relief. A few minutes later patient was given racemic epinephrine through the oxygen mask. There appeared to be mild improvement in her breathing as she appeared more comfortable, but still complaining of shortness of breath and vomiting. When EMS arrived patient was unable to transport herself to the stretcher. When EMS and clinical staff transferred patient to the stretcher she became unresponsive. She appeared to still be breathing. She did not respond to verbal stimuli. Per ED report large amount of fluid was suctioned from the patients lungs following intubation in the ambulance. When patient arrived to the ED she was extubated and re-intubated without difficulty and further fluid was suctioned. At that time patient was found to be in PEA, shock was delivered. Shortly thereafter no cardiac activity was found and patient pronounced dead.
58 2021-01-31 weakness Fever up to 102.4, tachycardia to 140, fatigue, chills, pain under left axilla, weakness, generalize... Read more
Fever up to 102.4, tachycardia to 140, fatigue, chills, pain under left axilla, weakness, generalized body aches
58 2021-01-31 burning sensation Jan 31, 430 pm - Red splotches front part of neck, chest, shoulders. A red welt above Left clavic... Read more
Jan 31, 430 pm - Red splotches front part of neck, chest, shoulders. A red welt above Left clavicle, did not itch, but burning sensation. Small node swelling in the clavicle space. Asthmatic flare in the evening and at midnite. Feb 1 - Less redness on skin, but, welt still present. Having chest tightness in the morning and continues as of this report.
58 2021-01-31 discomfort Severe pain and swelling in the lymph nodes of the left armpit. Swelling in the area of the vaccine.... Read more
Severe pain and swelling in the lymph nodes of the left armpit. Swelling in the area of the vaccine. The pain started on Friday night and today Monday continues. It has decreased in intensity but I am also having discomfort in the lymph nodes of the right arm and some discomfort in the breasts.
58 2021-01-31 difficulty speaking chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received E... Read more
chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received EPIPEN 0.3 mg 3 doses 5 min apart. then went to ER had two breathing treatments, albuterol, epinephrine, solumedrol one injection, 50 mg Benadryl reports rash at IV site from (Benadryl?) No rash anywhere else. Prednisone tapering dose and Benadryl 50 mg at night and 25 during day time. To follow up with PMD. Headache.
58 2021-01-31 feeling cold She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Dia... Read more
She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Diarrhea; She felt really bad; She experienced what felt like "a very bad cold"; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3302), via an unspecified route of administration at site of right arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included fibromyalgia from 2018 and ongoing, borderline diabetes from Feb2020 and ongoing. Concomitant medication included ongoing duloxetine for fibromyalgia, ongoing meloxicam for fibromyalgia, ongoing semaglutide (OZEMPIC) for borderline diabetes. Clinical course: After vaccination, Patient felt fine the first couple of days. On 15Jan2021, she experienced what felt like "a very bad cold", she had a severe headache. She also had diarrhea, a sore throat and she felt really bad on 16Jan2021. It was controlled with taking paracetamol (TYLENOL). Paracetamol made her headache better when she took it. On 18Jan2021, she felt a bit of congestion, an earache and really bad fatigue. She didn't know if these are side effects from the vaccines and if so, how long will last. The episodes of diarrhea came and went. Her sore throat is not as bad. She also had a runny nose and body aches on 17Jan2021. She received the vaccine because she worked as a front-line worker as a dental assistant. She felt like she has the symptoms of COVID. The outcome of event a very bad cold, felt really bad, body aches and earache was unknown; of events fatigue and runny nose was not recovered; of rest events was recovering.
58 2021-01-31 flushing Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administratio... Read more
Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administration the patient developed itching and a flushed feeling, tingling lips, racing heart rate, and headache. Patient reports these symptoms lasted several hours and then resolved.
58 2021-01-31 pain in extremity, migraine sore arm; massive migraine; fever of 102.5; achy body; not feeling well; room spinning; This is a sp... Read more
sore arm; massive migraine; fever of 102.5; achy body; not feeling well; room spinning; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm on 16Jan2021 at single dose for covid-19 immunization. The patient's medical history andconcomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EH9199), via an unspecified route of administration at left arm on 26Dec2020 at single dose for covid-19 immunization, after the first dose she had sore arm. The patient received second dose on 16Jan2021 after getting her first one 21 days ago, she had a terrible reaction to the second one and experienced massive migraine, fever of 102.5 degrees Fahrenheit, achy body, not feeling well, sore arm, room spinning, and it has been 48 hours or if this is an adverse reaction, or what is normal. she wants to if that is side effect with the vaccine, her side effects were much stronger after the second dose. She said that she was not sure because the first time she had vaccine she had minor side effect. The patient's fever that is better today (18Jan2021), it is 100 degrees Fahrenheit. She said she still doesn't feel 100%, but her husband who was a dentist, and their friends that were dentists, no one else was having a reaction, and she was not having an allergic reaction, it was just weird. For her fever she took Tylenol. The outcome of the fever was recovering, and the outcome of the other events was unknown. Information about lot and batch number was requested.
58 2021-01-31 pain in extremity Had Shot on Thursday. My arm is still red and sore. Hot to the touch. Worried it might be infected.
58 2021-02-01 speech disorder, flushing felt extremely thirsty; facial flushing; Mild hives on face neck and upper chest; Mild cognitive and... Read more
felt extremely thirsty; facial flushing; Mild hives on face neck and upper chest; Mild cognitive and speech slowing; Mild cognitive and speech slowing; Felt strange sensation on top of head; This is a spontaneous report from a contactable Other Health Professional (patient). A 58-year-old female (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 14Jan2021 04:00 PM (vaccine location: right arm) at single dose for COVID-19 immunisation.The patient's medical history included hashimotos, fibromyalgia, known allergies to sulfa drugs and extreme shellfish. There is no other vaccine in four weeks. The concomitant drug included levothyroxine sodium (SYNTHROID), Amitriptyline, Valsartan, Vitamin D. After about 12 mins from shot on 14Jan2021 04:15 PM, patient felt extremely thirsty. Then spouse noted facial flushing and called an advanced registered nurse practitioner (ARNP) on site to eval. Mild hives on face neck and upper chest developed then. Then increase flushing on face. Mild cognitive and speech slowing. Felt strange sensation on top of head. Self medicated with 50 mg Benadryl capsule. Emergency medical technician (EMT) and ARNP insisted should go to emergency room (ER), in ambulance not with spouse. Other treatment included OTC ongoing Benadryl and Pepcid. The outcome of events was recovered in Jan2021. Information on the batch number has been requested.
58 2021-02-01 unresponsive to stimuli Resident found unresponsive in room this am at approx. 9:30 am. Resident was observed eating breakfa... Read more
Resident found unresponsive in room this am at approx. 9:30 am. Resident was observed eating breakfast around 8:45 am. Housekeeper reported seeing resident between breakfast and time found unresponsive. Resident had voiced no complaints. Code was initiated until EMS arrived and transported resident to hospital. Resident expired.
58 2021-02-02 feeling hot About 2hr after the shot I got light headed, dizzy and hot. I got my bp taken of 173/100 and I sat ... Read more
About 2hr after the shot I got light headed, dizzy and hot. I got my bp taken of 173/100 and I sat for a while to see if it would go down being monitored by 2 NPs in the office. The BP remained elevated for a while and after about 2hrs it came down. I developed a headache that got more profound over time but the dizziness and feeling of being hot left and about 5hrs the headach left and I felt better. Went to work the next day feeling a little better but got a massive headache so I took some advil and after about 4hrs it finally let up. The next day I got a slight headache but it left after about an hour and hasnt had anymore symptoms since.
58 2021-02-02 flushing Patient c/o dizziness, flushed feeling, and syncope 10 min post-vaccine. Hx of same related to vacci... Read more
Patient c/o dizziness, flushed feeling, and syncope 10 min post-vaccine. Hx of same related to vaccines/venipuncture in past. Epi-pen given prior to obtaining vasovagal syncope hx. Patient awoke and symptoms improved.
58 2021-02-02 pain in extremity Night of vaccine had right leg pain from hip to ankle. On 12/22/2020 knee began to stiffen and swell... Read more
Night of vaccine had right leg pain from hip to ankle. On 12/22/2020 knee began to stiffen and swell while leg pain subsided. Knee swelling and pain continued for next week.
58 2021-02-03 feeling cold Received Shot at 9 am worked all day and was fine. Arrived home at 5:30pm same day had chills and Ac... Read more
Received Shot at 9 am worked all day and was fine. Arrived home at 5:30pm same day had chills and Aches all over and couldn't get warm (teeth chattering cold) also having dinner and couldn't eat much and was burping up dinner but never got sick. then the fever hit around 7pm 99.9 then elevated and through out the night took temperature. The highest got to 102.7. Had bad stabbing pains in the top of my head. Didn't take anything until 9 am next day was trying not to because they said if you can hold off so finally I couldn't take it anymore and I took 1000mg Tylenol. It helped, my fever is lower now 11:50 am but still not feeling well and have a slight headache.
58 2021-02-03 pain in extremity sore arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female p... Read more
sore arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EH9199) via an unspecified route of administration in left arm on 26Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of unknown.
58 2021-02-04 weakness Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospita... Read more
Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospitalized on 2/3 @ 11:30 am on 2/3/2021 2/5 @ 4 :30 pm Primary Care visit @ 3:30 pm on 2/5/2021
58 2021-02-04 migraine 2/1 awakened with multiple fingers swollen and painful middle joints only. Sausage fingers. This inc... Read more
2/1 awakened with multiple fingers swollen and painful middle joints only. Sausage fingers. This increased in severity I took nsaids topical steroids Saw rheumatologist who ordered prednisone snd multiple lab tests. Suspect autoimmune reaction triggered by vaccine in some way. Also have migraine
58 2021-02-05 feeling cold, tremor Headache , shaking a lot , to cold (my body)
58 2021-02-05 tingling Two hours after injection severe soreness, next day loss of range of motion, persistent pain around ... Read more
Two hours after injection severe soreness, next day loss of range of motion, persistent pain around shoulder, radiating pain down arm and tingling in fingers which continues into sixth day. Unable to sleep, loss of appetite, taking Tylenol prn, was taking Motrin prior.
58 2021-02-08 weakness, tremor fever, weakness, chills, shakiness, body aches
58 2021-02-09 weakness Pfizer COVID vaccine, symptoms still evolving and mimic COVID but negative COVID test. Have lost abi... Read more
Pfizer COVID vaccine, symptoms still evolving and mimic COVID but negative COVID test. Have lost ability to walk without a walker, severe weakness, fatigue, dizzy, distortion in hearing, metellic taste, body aches and joint pain, intermittent headache and nausea. No fever no cough.
58 2021-02-09 tingling, pain in extremity, numbness Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbn... Read more
Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbness; Muscle weakness; Swelling and pain in left arm; Swelling and pain in left arm - all the way down to hand; Swelling and pain in left arm - all the way down to hand; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3248) at single dose, in the left arm, on 21Jan2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included allergies to sulfa drugs and to wasps, fibromyalgia (autoimmune issues), rosacea, rheumatoid arthritis (RA) and frozen shoulder (L). Concomitant medications, received within 2 weeks of vaccination, included cannabidiol (CBD OIL), vitamin D (ergocalciferol), biotin and meloxicam (MEL). On 21Jan2021, at 03:00 PM, the patient experienced chills, muscle and joint aches, headache, injection site pain, tingling and numbness, muscle weakness, swelling and pain in left arm - all the way down to hand. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
58 2021-02-09 tingling 2/8/21 -10:00am patient noticed tingling in all ten fingers. Pt. denies taking anything for it. Pt. ... Read more
2/8/21 -10:00am patient noticed tingling in all ten fingers. Pt. denies taking anything for it. Pt. states that symptoms are improving.
58 2021-02-10 migraine Migraine headache, body & muscle aches, fever, insomnia
58 2021-02-11 tingling, pain in extremity Patient developed tingling/pins and needles twenty minutes after receiving first COVID vaccine. This... Read more
Patient developed tingling/pins and needles twenty minutes after receiving first COVID vaccine. This lasted about 30 minutes. Her legs ached and she had difficulty walking the next am (1/7/21). Patient usually takes the steps at work, but had to take steps 1/8/21 due to pain and generalized difficulty walking. On 1/9/21 patient was exhausted. Was standing on the bed of the truck and could not lift leg over tailgate. She also fell that day. She steadily improved beginning 1/10/21 until she was back to normal 1/17/21. MD advised that she could not get second vaccine.
58 2021-02-12 numbness Extreme drunken feeling that lasted over 2 hours and then returned in waves the following two days, ... Read more
Extreme drunken feeling that lasted over 2 hours and then returned in waves the following two days, in addition to facial numbness that lasted over an hour
58 2021-02-12 pain in extremity Sore arm, headaches, body aches, chills, fever, acidity, burning of eyes
58 2021-02-13 pain in extremity, tingling, numbness My right arm has been extremely painful ever since. To date I have been to 4 Dr's. I have had a MRI... Read more
My right arm has been extremely painful ever since. To date I have been to 4 Dr's. I have had a MRI, steroid injections, 4 medications. All with no relief. My arm shoots numbess feeling, tingling, tightness from shoulder to fingertips. It is getting worse. I am unable to do my job and household work.
58 2021-02-14 discomfort Developed a lump in left axilla(lymph node?) about golf ball sized. Lasted about 24 hours before beg... Read more
Developed a lump in left axilla(lymph node?) about golf ball sized. Lasted about 24 hours before began to resolve. Over next 48 hours resolved completely. Extreme discomfort!
58 2021-02-14 feeling hot Pt. felt hot and heart racing: No swelling BP:140/50 Denied SOB No itching HR: 87 02sat:98% Pt ... Read more
Pt. felt hot and heart racing: No swelling BP:140/50 Denied SOB No itching HR: 87 02sat:98% Pt offered and refused medical attention Pt. waited 1hr after vaccine
58 2021-02-15 difficulty speaking Pt reported feeling symptoms approx 10 minutes after receiving injection. She complained of mild sho... Read more
Pt reported feeling symptoms approx 10 minutes after receiving injection. She complained of mild shortness of breath and "itchy throat." She was questioned about having any other symptoms and immediately escorted to the medical attention tent. She was seated, and EMS began evaluation; her vital signs were taken: RR 22, HR 82, BP 156/102, PULSE OX 98%. She then reported an increase in symptoms, as face itching, increased tightness in her throat. Objective symptoms observed by myself and EMS: cough/clearing of the throat, increased SOB/labored breathing, facial erythema, hoarseness. EMS asked for her consent to give her Benadryl and Epinephrine. She repeatedly refused this, and refused any attempt at IV placement. She eventually agreed to IM Benadryl, of which 50mg were administered by EMS. Both EMS and I suggested more than once that she allow us to transfer her to the hospital for further management and preparation in the event that she needs further care. I explained that she was having symptoms of anaphylaxis. She repeatedly refused transfer. She reported a decrease in symptoms, saying she felt well enough to go home. Her objective symptoms observed by myself: continued hoarseness and clearing of the throat. VS were repeated: RR 18, HR 68, BP 160/98, PULSE OX 99%. Airway remained patent and clear. Patient again requested to leave, and agreed to EMS escorting her to her car.
58 2021-02-15 feeling hot muscle aches; joint aches; tired; chills; hot spells; stiff muscles
58 2021-02-15 numbness, tingling Numbness and tingling in hands, legs and face.
58 2021-02-16 weakness The morning after 2nd dose of Pfizer. I was weak and actually couldn't get my legs to go forward the... Read more
The morning after 2nd dose of Pfizer. I was weak and actually couldn't get my legs to go forward they gave out and I was on the floor unable to get back up on my own without staff assistance. I was very sweaty very dizzy and disorientated. not knowing who was around me. I had pain at injection site, no headache no body pain. Very tired slept took tylonal.
58 2021-02-17 breast pain Patient complained of Left lateral chest extending to Left underbreast pain, 3/10, dull, that occur... Read more
Patient complained of Left lateral chest extending to Left underbreast pain, 3/10, dull, that occurs only with deep inspiration and relieved by "not taking deep breaths." Patient denied pain on the area with normal breathing. Patient further described it as " a pulled muscle."
58 2021-02-17 pain in extremity Day 1-2 left arm pain, difficulty abducting left shoulder- resolved in 24 hrs Day 5 - anterior neck... Read more
Day 1-2 left arm pain, difficulty abducting left shoulder- resolved in 24 hrs Day 5 - anterior neck erythema rash - resolved after 12 hours with Benadryl
58 2021-02-18 weakness Patient developed extreme fatigue 2 days following the COVID vaccine which caused a clinical relapse... Read more
Patient developed extreme fatigue 2 days following the COVID vaccine which caused a clinical relapse of MS. No new radiographic lesions, but patient was/is much weaker than baseline.
58 2021-02-18 tingling Everything was good the first day. The next morning, I had severe chills that lasted about 6 hours. ... Read more
Everything was good the first day. The next morning, I had severe chills that lasted about 6 hours. During that time, I started getting a temp, the highest was 103.3. I called my doctor and she seemed convinced that it was something else because she hadn't seen that reaction before. I then had developed a headache. The fever took several days to go away. My doctor (via phone) told me to take Tylenol. I also had tingling in my right hand, extreme fatigue, joint stiffness and swollen lymph nodes, which remained swollen for at least a week. I was in bed for over 24 hours. It eventually started it get better after a few days. I also had an antibodies test before I got the vaccine and two days later I found out I had positive antibodies--and this was 6 months later (I had COVID in July). I had the same reaction with Dose 2.
58 2021-02-20 facial pain One hour after injection I experienced pain on the right side of my face. My preauricular lymph nod... Read more
One hour after injection I experienced pain on the right side of my face. My preauricular lymph node is painful and swollen two days after the second Covid vaccine.
58 2021-02-20 pain in extremity Mild bruising and swelling at injection sight (upper right arm), sore arm, and severe fatigue All ... Read more
Mild bruising and swelling at injection sight (upper right arm), sore arm, and severe fatigue All side effects lasted about 24 hours Treatment: exercise to help soreness and lots of sleep to help the fatigue....I slept about 14 hours!
58 2021-02-21 migraine soreness at injection site. then a mild migraine the following evening.
58 2021-02-21 pain in extremity The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and ... Read more
The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and fingers. I was told I was only to stay 15 minutes after the shot. On my way home from the vaccination about 30 minutes after the shot, I felt sick. I had a rapid heart rate and itch red hives on my left chest and left palm of my hand. My husband stopped along the road and gave me benadryl. I still had hives the next day. On the third day I had vaginal spotting and I am in menopause and I had extremely bad pain in my left hip, left thigh and left buttocks for 2 weeks. I could not sit or stand up to get relief. I cried with pain and thought I would never recover. I visited a urgent care and he suggested I see a neurologist for the pain. I was tested for covid at that time and was negative. I went to an allergist to see if I am allergic to the PEG in the vaccine. I am not allergic to the compound. She believes my body had a very strong immune response to the vaccine which caused all the symptoms described above. All symptoms were strictly limited to just the left side of my body. I do not know what to do about taking the second dose because I am afraid it will be worse.
58 2021-02-23 feeling hot Patient felt warm and lightheaded upon standing. Walked with assistance to lie down on a cot in the ... Read more
Patient felt warm and lightheaded upon standing. Walked with assistance to lie down on a cot in the patient care tent. BP: 128/70, P: 90, Resp: 17. Patient drank some water and ate pretzels while sitting and denied dizziness after 20 minutes of sitting up. Patient left the building feeling well and denied any dizziness.
58 2021-02-23 flushing, pain in extremity Within a few minutes of vaccination, flushing/sweating, throat swelling to a level of discomfort wi... Read more
Within a few minutes of vaccination, flushing/sweating, throat swelling to a level of discomfort with swallowing. I took 1 Benadryl and then another 15 minutes later, then drove home once rxn seemed to stabilize. Took 2 more Benadryl through the course of the evening as flushing stopped but still had throat discomfort and new headache. Also took Tylenol. In AM, allergic symptoms were resolved, but had significant arm pain (upper arm around site was very firm and warm to the touch), mild headache, moderate fatigue, and diarrhea. This continued for another 24 hours. Took Tylenol 3 times. Felt fine by Wednesday (2 days after vaccination).
58 2021-02-23 pain in extremity, numbness, tingling had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that... Read more
had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago. The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious. Information on lot/batch has been requested.
58 2021-02-25 feeling hot Fatigue, body aches, joint pain, feeling overly warm accompanied by sweating on face, headache, diar... Read more
Fatigue, body aches, joint pain, feeling overly warm accompanied by sweating on face, headache, diarrhea, mostly FATIGUE
58 2021-02-25 migraine continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneou... Read more
continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneous report received from a contactable consumer (patient's husband). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 25Jan2021, at single dose, for COVID-19 immunization. The patient medical history concomitant medications were not reported. It was reported that the patient got the COVID-19 shot in the morning of 25Jan2021 (yesterday) which developed into a migraine headache that has done nothing but gotten worse and on 26Jn2021, she had continued vomiting. The reporter asked if these were normal and how long will these last. The outcome of the events was not recovered. Information on lot/batch number has been requested.
58 2021-02-25 muscle spasms, feeling of body temperature change, pain in extremity After the second vaccination employee experienced minor symptoms on day 1 and day 2 with headaches, ... Read more
After the second vaccination employee experienced minor symptoms on day 1 and day 2 with headaches, feeling hot/cold alternating, arm pain, muscle aches. Day 3-5, employee became more sick with mild intermittent chest pains, extreme exhaustion, muscle aches and spasms, dizziness, headaches, feeling hot and cold alternating, but no fevers noted. Day 7, employee started to feel better, but symptoms continued with fatigue which persisted for a several days until she was back to baseline
58 2021-02-26 weakness Weak, dizzy, nausea, shoulders ache, cleared by medics
58 2021-02-27 numbness Numbness in face 10 minutes after injection. This lasted 15 minutes but has returned intermittently ... Read more
Numbness in face 10 minutes after injection. This lasted 15 minutes but has returned intermittently since vaccination. Intermittently have had some rashes and itching on neck and torso.
58 2021-02-28 flushing Dizziness, sweating, flushed followed by Syncopal episode, EMS called
58 2021-02-28 pain in extremity I received my 2nd dose of COVID 19 vaccine at around 1 p Thursday afternoon. Saturday around noon m... Read more
I received my 2nd dose of COVID 19 vaccine at around 1 p Thursday afternoon. Saturday around noon my arm started to itch a little and when I scratched it there was a large hard lump a little bigger than a golf ball under my skin. The skin was mildly rashy in appearance. It was red and warm to the touch. The affected area was approximately 3 inches below the injection site. The lump got smaller on Sunday and is smaller today. It is still red, warm to the touch, and sore when I rub over it. I did not seek medical treatment wanting to observe the area first. Since the lump has gotten smaller I will continue to observe it. I was advised by a friend who is a nurse that if it gets larger to seek medical treatment. That will be my plan.
58 2021-02-28 tingling This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT1... Read more
This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration by injection once to left arm, upper part, on 26Jan2021 at a single dose for COVID-19 immunization. The patient has no medical history. There were no concomitant medications. The patient experienced tingling on right side by cheek bone on 27Jan2021 and she did not have it yesterday, and the shot was on the left side, later clarified as the left arm. The outcome of the event was not recovered.
58 2021-03-01 migraine Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it fel... Read more
Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it felt I was having knee surgery without anthesis nothing helped with the pain. General aches through out whole body settling in the joints. Fatigue, migraine headache, loss of smell on and off through day. Loss of appetite on and off. Injection site has a large redden area warm to touch approximate size of a silver dollar if not bigger, lymph node under left arm pit is swollen and sensitive to the touch, movement aggravates the arm pit. Evening time body breaks down in an allergic rash.
58 2021-03-02 weakness, feeling hot After about 10 minutes I felt a wave of heat wash over me. Then I felt brief light-headedness and be... Read more
After about 10 minutes I felt a wave of heat wash over me. Then I felt brief light-headedness and begin experiencing shortness of breath. The shortness of breath would intensify and then abate but not like a panic attack it was directly related to the shot. After about 20 minutes is subsided 9 days later I still feel weak and fatigued. There was no emergency rescue precautions available for me had at the site had the situation worsen 3 weeks prior I had The first shot of my shingles vaccination.
58 2021-03-02 weakness slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a s... Read more
slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9262 and expiry date unknown, via unspecified route of administration at the left arm on 28Jan2021 11:15 at single dose for Covid-19 immunization in a hospital. Medical history included high blood pressure, depression, asthma, wheat allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lisinopril, paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), cyanocobalamin (VIT B12), ergocalciferol (VIT D); all from unspecified date for unspecified indication. The patient previously took amoxicilin, morphine, vicodin; all experienced drug allergy. Historical vaccine included first dose of BNT162B2 lot number EH9899 at the left arm on 07Jan2021 11:15 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 19:00, the patient experienced chills, fever 103.8 (temperature), weakness, headache, until 30Jan2021 6:30 am. Then again, on 30Jan2021 11 pm, the patient experienced fever, chills headache until 6:30 am. On 30Jan2021, the patient experienced arm redness at injection site. On 31Jan2021, the patient continued to experience redness and slight swelling (injection site). The patient has the patient been tested for COVID-19 since the vaccination. The patient did not received treatment for the events. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
58 2021-03-02 unresponsive to stimuli, weakness Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotens... Read more
Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe
58 2021-03-03 weakness zapped of energy; chilled; body aches; mild sore throat; slept about 15 hours; This is a spontaneous... Read more
zapped of energy; chilled; body aches; mild sore throat; slept about 15 hours; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN5318), via an unspecified route of administration single dose arm left on 29Jan2021 09:00 (at the age of 58) for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced zapped of energy on 31Jan2021 16:00, chilled on 31Jan2021 16:00, body aches on 31Jan2021 16:00, mild sore throat on 31Jan2021 16:00, slept about 15 hours on 31Jan2021 16:00. No treatment administered. The events outcome was recovered.
58 2021-03-03 breast pain Right Under arm Lymph node and right breast discomfort/ pain
58 2021-03-03 pain in extremity Having severe left arm pain which is affecting activates of daily living. Site of injection is not ... Read more
Having severe left arm pain which is affecting activates of daily living. Site of injection is not red or swollen, but I cannot lift my arm or sleep on my left side without pain. I have been treating with acupuncture and advil.
58 2021-03-04 feeling cold Heart palpitations, very cold feeling, chills. Wore full winter clothing in my house and while sleep... Read more
Heart palpitations, very cold feeling, chills. Wore full winter clothing in my house and while sleeping with blankets and a space heater
58 2021-03-04 fibromyalgia Pain on my extremities, unable to hold things with my hands, pain going down my left leg , pain from... Read more
Pain on my extremities, unable to hold things with my hands, pain going down my left leg , pain from my neck down my arms, deep depression, strong flare up of my Fibromyalgia and Arthrities together, Severe Headaches and very weak no energy at all and vomiting, nauseated. Dr. stated the shot case a neurological disorder causing the reaction stated above.
58 2021-03-04 numbness History of HTN, left-arm numbness, and ipsilateral dilated (blown) pupil about 2 minutes post vaccin... Read more
History of HTN, left-arm numbness, and ipsilateral dilated (blown) pupil about 2 minutes post vaccine. Transported to ED. Patient left the ED without treatment.
58 2021-03-04 nerve pain herpes zoster recurrence--typical neuropathic pain in right abdominal region. As I'm a physician who... Read more
herpes zoster recurrence--typical neuropathic pain in right abdominal region. As I'm a physician who is immunosuppressed and have experienced this previously and had valtrex on hand, I started it immediately and the pain resolved within three days. No rash developed due to rapid treatment.
58 2021-03-05 cold extremities Severe body aches at joints, headache, fever of 103, BP 197/110, heart rate 100-110, dizzy, nausea, ... Read more
Severe body aches at joints, headache, fever of 103, BP 197/110, heart rate 100-110, dizzy, nausea, difficulty focusing eyes. Aches started at 6:30 am. High heart rate noted at 10:00 am. The rest came on in the afternoon. Took my vitals when I got home from work (7 pm). Chills, cold extremities through the night. By 5am, temp down to 100. By noon next day, BP and HR normal. Dizziness still comes and goes.
58 2021-03-06 pain in extremity Dizzy, nauseous, fever, headache, arm pain, feeling unwell. Went back to bed to rest- so far.
58 2021-03-07 migraine felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Simila... Read more
felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Similar to a migraine; tired; slept for a long time; light and sound was very painful; light and sound was very painful; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration from 28Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included chronic sinus infections. Patient was not pregnant at the time of vaccination and the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone, xylometazoline hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC), and fluticasone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took clarithromycin (BIAXIN) and experienced allergies (reported as know allergies). About an hour after the injection, on 28Jan2021 11:00 AM, patient felt lightheaded, had a low grade fever, chills and sweating, light and sound was very painful - similar to a migraine even though patient have never had one previously, and patient was very tired and slept for a long time. These lasted for 5 days. The events required doctor or other healthcare professional office/clinic visit in response to the events. Patient received treatment for the adverse events and was reported as unknown. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events reported was recovering. Information on the lot/batch number has been requested.
58 2021-03-07 pain in extremity big bump that came on her right thumb/ It is on the hand right below the thumb where there is a norm... Read more
big bump that came on her right thumb/ It is on the hand right below the thumb where there is a normal bone, but on the side of the thumb it is enlarged./ she has a bump on her bone on the bottom of her thumb that is on the same arm as the vaccine; arm pain the next day and sore while sleeping the night of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1283, Expiry date: unknown), via an unspecified route of administration on 22Jan2021 at 01:30 (age at the time of vaccination was 58-years-old) on right arm at single dose to prevent from getting COVID. Medical history was none. The patient reported that, she is calling because she had her vaccination for COVID on the 22Jan2021. She has a big bump that came on her right thumb. She doesn't know if that is side effect. It is on the hand right below the thumb where there is a normal bone, but on the side of the thumb it is enlarged on 22Jan2021. She works in health facility. she is on two medications. One is a topical medication. The reporter did not provide the medication names. She doesn't think it is relevant. History of all previous immunization with the Pfizer vaccine considered as suspect were one. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No adverse event requires a visit to Emergency Room or Physician Office. No Prior Vaccinations (within 4 weeks). The patient stated that she has a bump on her bone on the bottom of her thumb that is on the same arm as the vaccine she reported arm pain the next day and sore while sleeping the night of the vaccine on 22Jan2021. she wanted to know if this is a side effect. Potential duplicate AE. She was provided information from the attached documents and referred her to HCP. The outcome of the event was not recovered.
58 2021-03-08 weakness Patient received second dose of Covid 19, Pfizer, at 8:10 am. Stated she was doing fine and left the... Read more
Patient received second dose of Covid 19, Pfizer, at 8:10 am. Stated she was doing fine and left the Clinic. At approx. 8:14 ambulance was called to truck stop. Patient was having weakness, shortness of breath and tongue swelling. Patient brought to Emergency Room. See enclosed notes.
58 2021-03-08 pain in extremity Sore arm and headache for 24 hours
58 2021-03-09 cold sweat I began feeling cold sweats and very tired that evening a few hours after taking the vaccine. Durin... Read more
I began feeling cold sweats and very tired that evening a few hours after taking the vaccine. During the night, I began having a severe headache, body aches, extremely lethargic and continued being feverish with sweats. I basically slept the next 2 days as These symptoms lasted in their severity until Friday, February 26th. I continued with a headache and lethargy until Saturday February 27th and finally felt better by Saturday evening and was 100% back to normal by Sunday. I missed 3 days of work dealing with the response to the vaccine but would do it all over again as I work as medical support and fully support the vaccines.
58 2021-03-09 feeling hot A few minutes after vaccine- patient felt light headed in the lobby. She did not feel well and got ... Read more
A few minutes after vaccine- patient felt light headed in the lobby. She did not feel well and got hot and felt like she was going to pass out. Patient did pass out while sitting in chair. She came back alert and felt much better. THe patient stayed in the lobby for a bit until she felt ok
58 2021-03-09 feeling jittery Dizzy/ Lightheaded Vitals: B/P: 140/70 HR: 77 Resp.: 14 O2Sat: 99% Skin signs: Warm and dry Circulat... Read more
Dizzy/ Lightheaded Vitals: B/P: 140/70 HR: 77 Resp.: 14 O2Sat: 99% Skin signs: Warm and dry Circulation: Cap refill <2sec Treatment: Pt placed in supine. States she still feels dizzy but room not spinning. Had patient sit up, no noted increase or decrease in symptoms. LOI 2 hours. Toast with peanut butter. No Hx of anaphylaxis. @ 11:30 pt states she feels "jittery" Repeat Assessment @11:32 Vitals: B/P: 134/70 HR: 68 Resp.: 14 O2sat: 98 % Skin signs: Cool/ dry Resp.: No noted increase in effort AOx4 Cap refill <2sec Treatment Pt remained supine. Pt states gradual return to normal. Vitals stable. Repeat Assessment @11:47 Vitals: B/P: 121/82 HR: 69 O2sat: 97%
58 2021-03-09 pain in extremity Pain in left arm from shoulder to elbow. Can?t lift arm above head or behind back without intense pa... Read more
Pain in left arm from shoulder to elbow. Can?t lift arm above head or behind back without intense pain.
58 2021-03-09 restless legs syndrome, numbness Numbness in center of face numbness tongue dry eyes dry mouth restless leg
58 2021-03-10 flushing, feeling hot warm feeling, flushing. Evaluated by EMS-Cleared
58 2021-03-10 numbness 15 minute waiting period I had no events, but 20 minutes after receiving vaccine I had metal taste i... Read more
15 minute waiting period I had no events, but 20 minutes after receiving vaccine I had metal taste in mouth on right side along with numbness on right side of face, right jawline, ear area, and small portion of tongue. No pain. No swelling. The metal taste dissipated in approximately 1/2 hour but numbness lasted until evening. By next morning, all symptoms were gone.
58 2021-03-10 pain in extremity, tenderness Slight shortness of breath lasting 15-20 minutes occurring 2 hrs. after injection Joint stiffness/... Read more
Slight shortness of breath lasting 15-20 minutes occurring 2 hrs. after injection Joint stiffness/soreness early next morning in limbs, with need to stretch, resulting in muscle soreness, lasted 2 hrs . Subsided after sleeping 1-2 hrs. (Possibly attributable to MEcfs symptoms, similar symptoms in past) Injection site stiffness/soreness during movement, early next morning, lasting 1-2 hrs (same time frame as above). Experienced no side effects with initial injection other than very slight tenderness to touch night of injection
58 2021-03-10 pain in extremity I could not move my right side from neck to finger tips by 5:30 p.m. I have never been in more pain ... Read more
I could not move my right side from neck to finger tips by 5:30 p.m. I have never been in more pain in my whole life. It was difficult to do anything and laying down hurt the most. This has been 8 nights now that I cannot sleep through the night because I wake up with shooting pains in my shoulder blade/shoulder/arm area. Even with ipruprophen and/or Tylenol - the pain still comes back. As of yesterday, I can use my arm better as the day goes by but lifting my arm over should height is extremly difficult and painful without the assistance from my other hand. I believe this is called a Shoulder Injury Related to Vaccine Administration. I writhed with pain the first night and got no sleep. I took 2 days off of work and even working today is difficult to write on the board, lift things or reach higher than my shoulder. Even last night I woke up 4 times because of the pain. I couldn't get back to sleep for about 1 hour each night since this happened 8 nights ago. When I visited my Doctor 2 days ago, she said maybe it was Shoulder Injury Related to Vaccine Administration. She said to come back for another visit if the pain lasts for a few more days. Physical Therapy, Steroids or ? I just want to be able to sleep, be able to dress myself and to wash my hair without pain.
58 2021-03-10 tremor Tremors, Itching, Tongue feeling numb,
58 2021-03-10 tremor Racing heart, dizzyness, shaking, heavy breathing.... Sort of like an anxiety attack. Started abou... Read more
Racing heart, dizzyness, shaking, heavy breathing.... Sort of like an anxiety attack. Started about 35 minutes after shot Directly after shot I felt a rush of blood and felt uneasy. They watched me for about 20 minutes but the severe symptoms started about 35 minutes after shot
58 2021-03-13 weakness Approximately 12 ours after the injection I was awoken with chills, and malaise, then felt tightenin... Read more
Approximately 12 ours after the injection I was awoken with chills, and malaise, then felt tightening around my back and abdomen and then started vomiting, dry heaves as if my stomach was cramping into knots. By morning , the nausea and vomiting continued and I had asked my health care provider to order Zofran. The Zofran helped , but I continued with some stomach cramps and general flu like symptoms for a total of about 48 hours. . My temp ranged from 100.3-102.4. After my symptoms subsided, I was still feeling weak enough that I was glad I did not have to go to work. It was probably after 3-4 days that I felt up to going to work.
58 2021-03-13 burning sensation About 2 days after vaccine my arm developed a red rash, not raised, just within the tissue . Oval in... Read more
About 2 days after vaccine my arm developed a red rash, not raised, just within the tissue . Oval in shape and slight spread down bicep area . Not itchy, but a slight warm as well as slight burning sensation. 5 days later still present but slowly disappearing.
58 2021-03-13 pain in extremity, weakness Day of, severe arm pain which was gone the next day. However, on 3/11/2021 woke with headache, naus... Read more
Day of, severe arm pain which was gone the next day. However, on 3/11/2021 woke with headache, nausea, all over muscle and joint pain, weakness. By mid day, eyes were irritated and sensitive to light. By 5:00, fever, chills, muscle aches, headache, joint pain, nausea, rapid pulse rate when walking. Symptoms lasted 3 days. On 4th day, no fever or chills but still painful headache and some muscle/joint pain and weakness.
58 2021-03-13 pain in extremity Arm was extremely sore for 24-48 hours. Aching from shoulder to below elbow is still present now ov... Read more
Arm was extremely sore for 24-48 hours. Aching from shoulder to below elbow is still present now over two weeks later - worse if I sleep on it. On Mar 3 both arms went completely limp and then discomfort/pain in upper back/neck area. Also became slightly nauseous and light headed. On Mar7 the exact symptoms happened again. I went to emergency room. Was also sent to a Cardiologist. So far nothing extreme has shown up. Mar 14 I had similar pain/discomfort in upper back/neck, but no limp arms. I'm advised to see a Neurologist, but am worried I won't get there before my next shot on Mar 18.
58 2021-03-14 bell's palsy Bell's Palsy
58 2021-03-14 burning sensation, tingling She had symptoms of shingles last Sunday; She noticed burning and tingling on the left side of her h... Read more
She had symptoms of shingles last Sunday; She noticed burning and tingling on the left side of her head; She noticed burning and tingling on the left side of her head; Shingles was reported as worsened; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) via unknown route of administration on 12Jan2021 14:00 PM at single dose in left arm for COVID-19 immunization at nursing home. Medical history included ongoing high blood pressure. Ongoing concomitant medication included metoprolol orally at 50 mg, once a day taking for 10 years and hydrochlorothiazide orally at 25 mg, once a day taking for 3 years both for high blood pressure, mecobalamin (B12) orally at 1000 ug, once a day taking 6 years for low b, colecalciferol (D3) orally at 100 ug, daily (50mcg; take two daily by mouth) taking for 6 years for low d. Patient received the first dose of the Pfizer covid vaccine on 12Jan2021 and her second dose was scheduled 02Feb2021. She had symptoms of shingles last Sunday on 29Jan2021 and was given famciclovir and was advised to not take the scheduled second dose of the vaccine. The next time that the vaccine will be given in their facility is on 22Feb2021-23Feb2021, and she wants to know if she can get the vaccine despite having shingles. However she came down with shingles. Adds she is being treated with Famciclovir 50mg; take three times daily by mouth. Her doctor recommended she not get the next dose of the Pfizer COVID 19 vaccine on 02Feb2021 so she stayed home and did not get it. Should she get the second dose? She noticed burning and tingling on the left side of her head in Jan2021 and then shingles on 29Jan2021 on the left eyebrow and hairline. Also shingles was reported as worsened in 2021. Adverse events required a visit to physician or ER was reported as Urgent care but not to the hospital. No Prior Vaccinations (within 4 weeks). The outcome of events shingles and condition worsened was not recovered, while for other events was unknown. No follow-up attempts are possible. No further information is expected.
58 2021-03-14 migraine Migraine headache, severe body ache pain, runny nose, swollen glands in the neck, arms, legs, feet, ... Read more
Migraine headache, severe body ache pain, runny nose, swollen glands in the neck, arms, legs, feet, and hand swelling.
58 2021-03-15 weakness Chills,headache,diarrhea,nausea,tired feeling,weak
58 2021-03-15 involuntary muscle movements, weakness, muscle twitching, hot flush -1.5 hours after shot, intractable vomiting for 14 hours, could keep nothing down, not even ice chip... Read more
-1.5 hours after shot, intractable vomiting for 14 hours, could keep nothing down, not even ice chips,- ended up treating with ondansetron 2- 5 mg doses-no appetite for at least 4 days and resultant weight loss of 6-8 lbs -balance impaired, vision blurred about 12 hours after-lasting 12 hours -confusion from about 12 hours post vaccine until 24 hours post vaccine -weakness, and hand and leg diskinesia about 12 hours after -lasting 12 hours -sore throat, phlegm 48 hours after for 12 hours -hyper alertness and unable to sleep almost 48 hours -twitching during sleep (throughout body, arms and legs) and in evenings which lasted 6 days, slowly abating over time -headache -multiple hot flashes 3-4/hour first 2 days mostly at night, way more than I normally have (I usually have 2-3 a night and 1-2 during the day-4 days/week) Shot on 2/8/21 and finally felt back to normal, resumed all normal activities including exercise 2/14/2021
58 2021-03-15 pain in extremity, weakness I had a headache on 3/10 throwing up 3/11 muscle pain, chills, joint pain, fever, trouble breathing,... Read more
I had a headache on 3/10 throwing up 3/11 muscle pain, chills, joint pain, fever, trouble breathing, weakness, sore throat, runny nose, left side of throat felt swollen. on 3/12 I felt like the inside of my body arms legs etc all hurt. Tylenol and Hydrocodone didn't help and i was drinking lots of water but vomiting and not peeing a lot. I took meds for my nose and throat but it didn't help. I have weakness still and chills come and go.
58 2021-03-16 numbness Numbness in face, neck and mouth. Red Rash on face and neck. Dizzy.
58 2021-03-16 numbness facial and tongue numbness for 1 full day and still feeling it at this time
58 2021-03-16 pain in extremity I few hours after I received a shot my arm hurt, within 12 hours right above where I received a shot... Read more
I few hours after I received a shot my arm hurt, within 12 hours right above where I received a shot waas incredibly painful. I took Tylenol ,it subsided it has continued to hurt since then. If I touch the spot above my shot it hurts worse. When I received a shot it did hurt when she stuck me, but I do have upper arm muscles .I am in shape, no fat on my arm. Some wondering if injecting it into my muscle is the reason why my arm hurts so bad. I compared notes with my friend whose 40 also in shape and his arm hurts like heck also.
58 2021-03-16 pain in extremity swollen fingers; joint started hurting; cannot hold fine item; My both hand fingers were drum sticks... Read more
swollen fingers; joint started hurting; cannot hold fine item; My both hand fingers were drum sticks painful/Fingers hurting, I am cutting and dropping things more frequently; This is a spontaneous report from a contactable nurse (patient). A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN9899) intramuscularly in the left arm on 26Dec2020 at 08:30 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included migraine from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications ("other medications in two weeks") were reported as none. The patient previously received epinephrine on an unspecified date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 06:00 the patient experienced swollen fingers, joint started hurting, cannot hold fine item and my both hand fingers were drum sticks painful/fingers hurting, I am cutting and dropping things more frequently. The events all resulted in doctor visits and were all serious for disability or permanent damage. The clinical course was reported as follows: "I developed swollen fingers, joint started hurting. My both hand fingers were drum sticks painful (as reported). I had no idea what was going on, things getting my ankle knees (as reported). I consulted internal medicine; I was referred to Rheumatology Clinic. All blood work was negative. All serology testing done was negative. Joints hurting. The doctor asked me to start taking Motrin which made my situation worse. I gave up. Miserable situation. I consulted another FPC who advised I give it time. I cannot hold fine item. Fingers hurting, I am cutting and dropping things more frequently. I am a healthy person. No medication. No complications." The patient asked if there were any solutions. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN9231) intramuscularly in the left arm on 15Jan2021 (at the age of 58-years-old) as a single dose for COVID-19 immunization. The patient received treatment for the adverse events which included Ibuprofen 400mg for pain. The clinical outcomes of the events swollen fingers, joint started hurting, cannot hold fine item and my both hand fingers were drum sticks painful/fingers hurting, I am cutting and dropping things more frequently were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
58 2021-03-16 tingling Patient presented with numbness/tingling in mouth, a slight cough. Progressed to become nauseated wi... Read more
Patient presented with numbness/tingling in mouth, a slight cough. Progressed to become nauseated with tingling down arms and legs. Blood pressures in the 150/90s, HR 86, 98% O2 saturation, and alert/oriented. Patient was placed in a supine position and monitored. EMS was called as symptoms persisted and increased.
58 2021-03-17 weakness extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like... Read more
extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like jelly; felt unsteady & like I would fall; felt so bad/felt awful/talking about end of life wishes; no appetite; chest tightness; This is a spontaneous report from a contactable other health care professional reported for herself. A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 09Feb2021 16:30 (at the age of 58-year-old) at single dose in left arm for covid-19 immunization. Medical history included Heart Failure, Sarcoidosis, Asthma, Obesity and Covid from Apr2020 to an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included prednisone, carvedilol (COREG), spironolactone (ALDACTONE), hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The day of injection on 09Feb2021 at 16:30 PM that same night 8 pm the patient started experiencing some chest tightness. Since the patient live in country when she left work(hospital). At that point she took 50mg of P.O. benadryl (diphenhydramine). So the patient just took time and hung around town. She went to family dollar then publix. She felt better at 9 pm so and went home. The next morning (on 10Feb2021 her legs were like jelly when she woke up to go to bathroom. She felt unsteady and like she would fall. Next thing she just felt so bad and no appetite so she ate nothing that day. Her temp started rising and by 2PM on 10Feb2021 it was up to 102.4, the patient felt so awful then the feeling of doom set in so she was talking about end of life wishes. She had Covid back in Apr2020 and it was like reliving it again. On 11Feb2021 she felt better but had to call out low grade 99.4 only she was able to eat some but extremely weak and right shoulder pain (moderate). Friday (on 12Feb2021) she went to work but still felt weak. She felt better over the weekend (Feb2021). Here we were 17Feb2021 and still not completely there but 90% better. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for other adverse event. The patient underwent lab tests and procedures which included body temperature: 102.4 on 10Feb2021, body temperature: 99.4 on 11Feb2021, Nasal Swab Covid-19/SARS: negative on 16Feb2021. The outcome of the events was reported as recovered in Feb2021. Information on the lot/batch number has been requested.
58 2021-03-17 breast pain After first vaccine I developed a rash under both arms that was hard pustules and then the skin beca... Read more
After first vaccine I developed a rash under both arms that was hard pustules and then the skin became very sensitive and my breasts became sore and swollen. I also had swelling under my injection site arm. This almost cleared up before my 2nd vaccine except for the skin sensitivity and swelling under both arms. After the 2nd vaccine 3/3/21 within 48 hours my breasts became very swollen and painful and the under arm sensitivity became much worse. It is 2 weeks since the second dose and my breasts are still slightly swollen and tender. This is hopefully resolving, but was very painful and uncomfortable.
58 2021-03-17 numbness Approximately 30 minutes after receiving vaccine patient experienced numbness on the left side of he... Read more
Approximately 30 minutes after receiving vaccine patient experienced numbness on the left side of her tongue and cheek. This lasted about one hour, but the numbness progressed to her left jaw and left cheek and then her whole head. The next morning the numbness was at the base of her skull and lasted most of the day. All symptoms resolved within 48 hours of the vaccine. On 3/16/2021 patient reported slight numbness of her whole head during the day. This resolved within a few hours.
58 2021-03-17 pain in extremity Chest pain, shortness of breath, pain in the left arm, joints , head and neck. She also had itching ... Read more
Chest pain, shortness of breath, pain in the left arm, joints , head and neck. She also had itching all over, as well as a sore throat. She did not go to the ER. She treated symptoms with Tylenol. Symptoms were intermittent and lasted 2 weeks
58 2021-03-18 numbness, pain in extremity, weakness, cold sweat Day 1. 3/10/2021- In the evening my left arm was sore and achy. Day 2. 3/11/2021- In the morning, ch... Read more
Day 1. 3/10/2021- In the evening my left arm was sore and achy. Day 2. 3/11/2021- In the morning, chills, headache, sweats. Early afternoon in the car I had trouble breathing, cold sweats, chills, coughing trying to breathe. My husband went immediately to the pharmacy to purchase Benadryl and opened the capsules and poured in my mouth along with water as my body became completely limp. At home my husband helped me get to bed and gave me 2 rapid release Tylenol tablets. Day 3. 3/12/2021- In the morning, I felt better until I had a cup of coffee and the chills, sweats, nausea, vomiting and blood pressure started escalating 135/98. I had no previous concerns with blood pressure before the vaccine. I had difficulty speaking (stuttering, confusion and brain fog. I was still so so tired. Day 4, 3/13/2020 - Unable to remain awake after having a sip of water. Blood pressure 150/101 and ate 3 nuggets and body became limp again and unable to walk and husband carried me to bed. (Difficulty speaking and repeating words over and over-confusion). Day 5, 3/14/2020- In the morning, I felt better and my husband gave me a blood pressure pill (Triamterene/Hctz) . I slept most of the day and had no water, no food. I was extremely exhausted and ate in the evening. I had chills, sweats, headache and my body became limp again and husband carried me to bed. Day 6. 3/15/2020- In the morning called Dr. for tele-visit and gave her details of what was happening. I had no food or water and still felt tired. I went to office for lab work around 4:30. I was walking, but extremely exhausted and speech difficulty. Day 7. 3/16/2021 -. In the morning blood pressure was 139/96 - took another blood pressure tablet and had a smoothie and felt much better only chills, no headache. Blood test were normal, and I ate dinner and then chills, sweats, headache and husband helped me walk to bed. After about 30 minutes, legs were movable, but upper body was numb for an additional 30 minutes and then everything seemed fine. I got up and walk around and went back to bed later in the evening. Day 8. 3/17/2021-First day no meds at all, no BP meds, no Tylenol and I was feeling so much better. I ate throughout the day with few symptoms except stuttering and repeating words when speaking. Day 9. 3/18/2021- I spoke with Dr. for appointment on the 19th. I felt stronger and ate breakfast, Lunch and dinner and was feeling normal except for occasional stuttering in speech. Day 10 3/19/2021 - No food in the morning, I visited Dr. at 8:35 for examination and she sent me for ct-scan. Blood pressure was back to normal 122/82 with no meds. I felt fine and later today received normal results from CT-scan. I am hopeful that in the coming days, my speech will completely back to normal.
58 2021-03-18 numbness Patient started with teeth numbness, tongue numbness, became nauseated. Tongue started swelling, fin... Read more
Patient started with teeth numbness, tongue numbness, became nauseated. Tongue started swelling, finger numbness. Benadryl was given at 1046.u
58 2021-03-18 numbness Numbness along the entire length of left arm, back of hand, shoulder (front & back), left side of ne... Read more
Numbness along the entire length of left arm, back of hand, shoulder (front & back), left side of neck (front, back & side), left side of face, left ear and left backside of head. Noticed approximately 1 hour after injection and continues through this moment.
58 2021-03-18 numbness tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, an... Read more
tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, and part of cheek close to her mouth went numb; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 58-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on Left arm on 03Feb2021 15:59 at single dose for covid-19 immunisation administered at state facility. Medical history included Asthma (diagnosed about 5 or 6 years ago, states she has probably had it all her life) and Fibromyalgia (diagnosed about 20 years ago). Historical vaccine includes Shingrix shot on an unspecified date, she did not feel well for a day, she felt sick but then it resolved it. The patient's concomitant medications includes pregabalin (LYRICA) at 250 mg (It is a 50mg capsule, she takes 100mg in the morning and 150mg in the evening) for Fibromyalgia; budesonide, formoterol fumarate (SYMBICORT) at 2x/day (two puffs twice a day) for Asthma and montelukast sodium (SINGULAIR) at 20 mg, 1x/day (once a day). The patient reported that she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. 45-60 minutes after, she felt the tip of her tongue, lips and part of her cheek become numb. She said this went away after 30 minutes. Consumer wants to know what reactions can she expect after she receives the 2nd dose, and if it would be worse than her reaction with the 1st dose. Asking if she should take Benadryl before the second dose. She is asking if she would have more of a problem. States she is an allergic person. She stayed at the facility for 30 minutes. Event occurred while she was driving, she thought if it got worse, she would go to the hospital but then it went away. The patient took covid vaccine for preventive action. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events resolved. Information on the lot/batch number has been requested.
58 2021-03-18 night sweats 5 days after my FIRST COVID shot, I experienced symptoms identical to what others have reported foll... Read more
5 days after my FIRST COVID shot, I experienced symptoms identical to what others have reported following the second shot: extreme fatigue, headache, achiness, night sweats, and fever. I did have a UTI at the time but I believe the symptoms are unrelated to that. It was a mild UTI and cleared up quickly on antibiotics, while the other symptoms persisted for 3 days.
58 2021-03-18 pain in extremity FEVER JOINT PAIN HEADACHE BACK PAIN ARM PAIN NAUSEA, same as when I actually had covid back in Nov
58 2021-03-18 pain in extremity arm sore to touch; swollen/puffed up underneath her arm, thinks is a swollen lymph node; swollen/pu... Read more
arm sore to touch; swollen/puffed up underneath her arm, thinks is a swollen lymph node; swollen/puffed up underneath her arm, thinks is a swollen lymph node; Itchy; restless; seems like she has a rash in her upper chest neck area, neckline; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EK9231) via an Intramuscular route of administration on 27Jan2021 at single dose on left arm for covid-19 immunization. The patient medical history included allergies. The patient concomitant medications were not reported. On 27Jan2021, in evening patient was really restless that night because she was itchy. Physician stated that patient has been experiencing some itching, but it seems like she has a rash in her upper chest neck area, neckline. The itching/rash has stayed the same so far. On 28Jan2021, next day morning It was really sore to touch, like when patient was putting deodorant on, its all puffed out underneath her arm that she had the vaccine administer in. It's swollen, but patient thinks its her lymph node. It doesn't feel like its effected any other one, but just that one lymph node. The outcome of the event Itchy, rash was not recovered while outcome of rest all events was unknown.
58 2021-03-18 cold extremities Reaction to vaccine similar to historical reaction to flu vaccine. Starting with cold hand and progr... Read more
Reaction to vaccine similar to historical reaction to flu vaccine. Starting with cold hand and progressing to coughing fit. Patient took medication recommended by allergist. 50mg Benadryl and 2x puffs albuterol inhaler from home.
58 2021-03-19 numbness Right hand numbness 5 minutes after vaccine administration, coughing fit 20-25 minutes after vaccine... Read more
Right hand numbness 5 minutes after vaccine administration, coughing fit 20-25 minutes after vaccine administration that lasted for several hours
58 2021-03-19 tingling She had received her first Covid vaccination this afternoon and following that she became dizzy and ... Read more
She had received her first Covid vaccination this afternoon and following that she became dizzy and had a syncope spell. She tells me that with previous vaccinations this has routinely happened and so it is not different. She was not aware of her surroundings for about 2 minutes after this happened although there was no witnessed jerking or seizure movement. At this point she feels about 90 to 95% back to normal and denies any pain anywhere including in her chest. Initially she had some tingling in her arms although that has resolved.
58 2021-03-20 burning sensation slight burning sensation R chest. Evaluated by EMS-Cleared.
58 2021-03-20 feeling hot Severe red rash and swelling on right side of the of my face/Spreading gradually to other areas of m... Read more
Severe red rash and swelling on right side of the of my face/Spreading gradually to other areas of my face and scalp; Severe red rash and swelling on right side of the of my face; extremely tender and hot to the touch/ very painful; Extremely tender and hot to the touch; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration in left arm at the age of 58-years (non-pregnant at the time of vaccination), on 10Feb2021 at 08:30 AM at single dose (dose number: 1) for COVID-19 immunization. The patient's medical history included alopecia areata and allergy to Xatham gum. Concomitant medication included valsartan at 160 mg. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. It was reported that on 10Feb2021 at 03:00 PM, "severe red rash and swelling on right side of my face. Extremely tender and hot to the touch. Spreading gradually to other areas of my face and scalp. Very painful". The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received diphenhydramine (BENADRYL) and 20 mg prednisone for 5 days and paracetamol (TYLENOL) as treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
58 2021-03-21 weakness Unlike first shot, these are different: headaches, diarrhea, sore throat, tired and sleepy lethargi... Read more
Unlike first shot, these are different: headaches, diarrhea, sore throat, tired and sleepy lethargic, not much energy.
58 2021-03-21 breast pain Pain in left breast and under armpit
58 2021-03-21 burning sensation As I was driving home my face started to burn like a bad sunburn. When I got home my face was blotc... Read more
As I was driving home my face started to burn like a bad sunburn. When I got home my face was blotchy and my eyes started to swell. I took benedryl and applied a cool pack. Redness and swelling around mybeyes lasted for 2+ days. Still not feeling well and have scheduled a doctor appointment for tomorrow.
58 2021-03-21 hot flush, tingling Patient states she had hot flashes and feeling funny, tingling in fingers. Had patient sit. BP monit... Read more
Patient states she had hot flashes and feeling funny, tingling in fingers. Had patient sit. BP monitored every 5 minutes x 7. Patient states she had not eaten this morning. Patient was given water and a snack, tolerated well. BP 191/93 HR 73 8:50 am, 187/100 HR 69, 188/89 HR 61, 148/87 HR 61,130/64 HR57, 155/80 HR 65,156/90 HR 68 Patient transported to Urgent care Walk in clinic. Reported off to urgent care nurse.
58 2021-03-21 numbness Swelling tongue, swelling throat, numbness on face, lips, headache nausea, numbness feet, numbness ... Read more
Swelling tongue, swelling throat, numbness on face, lips, headache nausea, numbness feet, numbness hands
58 2021-03-21 pain in extremity acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pai... Read more
acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pain; headache; nausea; Severe arm pain; feeling of unwell set in; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 28Feb2021 (Batch/Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included Sjogren's syndrome, mixed connective tissue disease, COVID-19 from Mar2020. Patient was not pregnant. Patient had no known allergies. Concomitant medications included estrogens conjugated (PREMARIN), tizanidine, hydroxychloroquine, acyclovir [aciclovir], all taken for an unspecified indication, start and stop date were not reported. 4 hours later (28Feb2021 20:30), severe arm pain & feeling of unwell set in. 24 hours later (01Mar2021 16:30) 102 fever, body aches, chills joint pain, headache and nausea for 15 hours and although it improved, patient never felt back to normal. Day 10 (10Mar2021 19:00) patient started having severe abdominal pain, nausea, headache and body pains. Day 11 (11Mar2021) it was worse and day 12 (12Mar2021) patient went to ER and was diagnosed with acute appendicitis and had surgery for appendix removal. Patient feel the vaccine caused this as patient had no issues that would allude to a problem and after receiving the vaccine never felt good. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Patient was hospitalized for 1 day. Patient had nasal swab: negative on 12Mar2021. Outcome of the events was resolving.
58 2021-03-21 cold extremities, numbness Woke up with my feet feeling like they were freezing cold, toes on left foot feeling some what numb ... Read more
Woke up with my feet feeling like they were freezing cold, toes on left foot feeling some what numb and toes on right foot tingling like they were very cold BUT I WAS NOT COLD. Put feet next to heater, put on socks/shoes, walked around but not much better. Massaged feet often for several hours and around noon they started feeling normal although left big toe and the bottom of my toes still kind of tingly. I'm not a diabetic. My feet didn't feel cold to the touch; even when get next to heater I my feet felt the warmth of the heater but they still felt freezing cold, like the end of a day snow skiing.
58 2021-03-21 tenderness, discomfort I woke up Sunday morning (about 40 hours after the vaccine) with pain in my shoulders, clavicle, col... Read more
I woke up Sunday morning (about 40 hours after the vaccine) with pain in my shoulders, clavicle, collarbone - also had pressure on collarbone, sensitive to touch, and some cough. Pressure and cough have subsided this morning , pain is still present. It hurts once in a while when swallowing and neck area I checked the lymph nodes at hurt some (I examined my neck like a doctor would to feel for possible swollen lymph nodes but can't tell if they are swollen or not). I put "no" under recovered because the pain is still there.
58 2021-03-22 weakness, cold sweat patient became clammy weak and almost fainted after shot she appeared pale and disoriented we call 9... Read more
patient became clammy weak and almost fainted after shot she appeared pale and disoriented we call 911 and EMT came checked vitals her blood pressure was low and they took her by ambulance to hospital
58 2021-03-22 weakness faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a co... Read more
faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 16:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as health clinic. Relevant medical history included overweight from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and omeprazole (PRILOSEC); both were taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 05Mar2021 at 21:15, the patient experienced faint, blurred vision, vomit, diarrhea, hot sweats, and weakness. The patient did not receive any treatment for the adverse events (AE). The patient was recovering from all the events. Information on the batch/lot number has been requested.
58 2021-03-22 flushing I became flushed and it lasted a few days. it feels like a sunburn from the inside out and it was fr... Read more
I became flushed and it lasted a few days. it feels like a sunburn from the inside out and it was from the neck up. then I had a tingly tongue and a metallic taste in my mouth. it did NOT swell, it just didn't feel right. has resolved by today 03/23
58 2021-03-22 numbness, tremor Arm feels dead, heavy, lifeless. Face numb. shortness of breath, shaking
58 2021-03-22 numbness Patient received first dose Pzifer vaccine on 3/2/21. On 3/6/21, patient went to emergency room with... Read more
Patient received first dose Pzifer vaccine on 3/2/21. On 3/6/21, patient went to emergency room with right side body numbness, wheezing, and high anxiety. She was given nebulizer treatment , prednisone, and an albuterol inhaler. She was tested for covid and flu, and both were negative. She also states that since her dose, she has had "covid arm", which consists of pain at the injection site and hand/lower arm numbness.
58 2021-03-22 muscle spasms Patient reported muscle spasms starting 3/14/21 in evening, on 3/17 patient reported a red spreading... Read more
Patient reported muscle spasms starting 3/14/21 in evening, on 3/17 patient reported a red spreading area on arm below the site of injection. Patient sought medical help that day and initial diagnosis was possible cellulitis.
58 2021-03-22 pain in extremity Arm pain, headache, fever, chills, body aches, nausea, dizziness, sore throat
58 2021-03-22 pain in extremity Severe pain throughout body but especially in the back radiating into right leg Wednesday, Thursday,... Read more
Severe pain throughout body but especially in the back radiating into right leg Wednesday, Thursday, Friday, Saturday nights to present. Leg weakness Saturday to present.
58 2021-03-23 feeling jittery I received the vaccine and waited the 15 minutes with no issues (just felt a little jittery). I beg... Read more
I received the vaccine and waited the 15 minutes with no issues (just felt a little jittery). I began the drive home and began feeling some nausea around 10 am. I thought it was because I had not eaten, so I stopped and picked up breakfast (scrambled egg with cheese and bacon). I got home, ate breakfast and then began logging in for work and the nausea grew. Around 11:30 am, I felt tired and the need to lie down, which I did for a while, then around 20 minutes later, I got up to go to the bathroom, feeling like I was going to vomit and have diarrhea. When I stood up, I felt really lightheaded, managed to only remove my pants and then got in the tub where I could lie down. I vomited (once) and had diarrhea for I don't know how long. At some point I was able to sit up and use my handheld shower to rinse off and get back to bed where I slept until about 4:30 pm. No more nausea although I am playing it safe and eating crackers and drinking ginger ale. I feel better now. Not sure it this was related to not eating and taking my antidepressant, food poisoning, or the vaccine. But felt I should report.
58 2021-03-23 numbness After about 40 minutes after administration, developed left facial numbness and chest pain rating 2/... Read more
After about 40 minutes after administration, developed left facial numbness and chest pain rating 2/10. First response called and patient taken to ER for further monitoring.
58 2021-03-23 tingling Within 1 minute I felt it run down my arm and my 3 fingers , middle , ring, pinkie finger when ting... Read more
Within 1 minute I felt it run down my arm and my 3 fingers , middle , ring, pinkie finger when tingling , then I felt it run across my chest and my heart or lungs physically hurt then it went to my head and from the moment on if I turned my head in any direction left or right I would be very dizzy. I could keep my head and vision straight ahead and only felt a distance and had to concentrate very hard .
58 2021-03-23 tremor, weakness Starting at approx 12 hours after shot, had severe shaking, chills, pain and weakness. THese severe ... Read more
Starting at approx 12 hours after shot, had severe shaking, chills, pain and weakness. THese severe teeth chattering shakes and chills lasted about 8 hours, the severe weakness lasted about 10 hours and the extreme pain lasted about 10 hours. The pain started in left shoulder and spread and seemed to be lingering in my joints for many hours. After the initial 10 hours the extreme sysmptoms were less, but I had a fever of about 102. The fever lasted about 2 -3 days total with the addition of a headache that came in waves throughout those 2 days. I was somewhat weak throughout that, but by day 3 I was feeling much better. 100% better by day 5. I took some tylenol starting the morning of the 19th at about 10am. Tylenol occasionally for 2 days. 500mg every 4 hrs or 1,000 mg every 6-8 hrs.
58 2021-03-24 burning sensation, hot flush Rash on face and body, burning sensation and hot flashes: began the evening after shot and mostly re... Read more
Rash on face and body, burning sensation and hot flashes: began the evening after shot and mostly resolved by day 4, took Benadryl Mild shortness of breath: began the evening after shot and only lasted 24 hours Severe nausea and diarrhea: developed that evening and better by day 4
58 2021-03-24 discomfort Situation: Pt here for covid vaccine #2. After vaccination pt experienced reaction. Background: ... Read more
Situation: Pt here for covid vaccine #2. After vaccination pt experienced reaction. Background: @ 0815 TEAM ALERT was called to covid vaccine clinic. This RN arrived @ 0818 to find pt sitting in chair in observation room. Received report from RN, pt received covid vaccine #2 and began experiencing cough, clearing throat, runny nose, and chills. Benadryl 25mg PO given @ 0810. Overall discomfort 1/10. 0818: VS: BP 132/98. HR 63. R 14. O2 Sat 98%. Pt c/o clearing throat, chills, coughing, itchy throat, itchy chest. Pt alert & oriented. 0820: overall discomfort 3/10. 0828: VS: BP 124/92. HR 63. O2 Sat 100%. Still experiencing above symptoms plus dizzines, lip numbness and discomfort in diaphragm region. "feels like it won't go down. Like something is stuck there." pt moved to gurney in hallway. 0842: VS: BP 122/86. HR 63. O2 Sat 100%. Pt still feeling diaphragm discomfort. States other symptoms are resolving. Noted pt no longer clearing throat. States lip numbness improved and diaphragm discomfort improving. Pt alert & oriented. 0855: Manager, spoke to pt. Advised pt she may go home when she feels okay. Pt states she feels well enough to go home. This RN advised pt to go home and relax for the remainder of the day, benadryl will make her feel sleepy. Advised pt to watch for symptoms of shortness of breath, difficulty breathing, and chest pain and go to ED if she experiences any of those symptoms. Pt verbalized understanding. VS: BP 118/72. HR 63. O2 Sat 100%. 0857: Pt left covid vaccine clinic ambulatory in stable condition. COVID Vaccine Worksheet 1. Did the patient have an immediate allergic reaction of any severity such as urticaria, angioedema, respiratory distress, or anaphylaxis (<4 hours following administration of the COVID vaccine)? Yes 2. Did the patient previously have an immediate allergic reaction of any severity to polysorbate or polyethylene glycol? No 3. Has the patient had prior anaphylactic reactions from another vaccine, medication or any other cause? No 4. Did the patient have an allergic reaction >4 hours after administration? OR have an expected side effect of the COVID vaccine? No Assessment: Pt had reaction to covid vaccine. Pt reported previous reaction to first dose with similar symptoms. After close observation and benadryl 25mg PO pt symptoms resolved and pt was able to leave clinic ambulatory in stable condition.
58 2021-03-24 flushing Client reported feeling flushed shortly after being vaccinated. Described itchy "red blotches", hiv... Read more
Client reported feeling flushed shortly after being vaccinated. Described itchy "red blotches", hives on face and chest. Client with hx of Lupus and multiple allergies to various medications. Client stated hives resolved after taking Benedryl. Client with no other symptoms or complaints at this time.
58 2021-03-24 numbness, tingling, pain in extremity Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day ... Read more
Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day one
58 2021-03-24 numbness and pain in extremities 1/14 received vaccine. Presented to clinic 1/19 with headache and dizziness. Blood presure at home 1... Read more
1/14 received vaccine. Presented to clinic 1/19 with headache and dizziness. Blood presure at home 157/80, took an additional 5mg amlodipine and tylenol and came to work. Headache and dizziness returned, BP in clinic 168/90. She ended up taking a leave of absence from work and is currently complaining of neuropathy and headaches, has been referred to neurology.
58 2021-03-24 pain in extremity fever, chills, headache, arm pain, nausea, tiredness -2 days
58 2021-03-24 pain in extremity Severe arm pain, chills, body aches, severe fatigue
58 2021-03-24 pain in extremity Intense, chronic pain on my neck, shoulder and upper arm (even if my arm is stationary). Pain exacer... Read more
Intense, chronic pain on my neck, shoulder and upper arm (even if my arm is stationary). Pain exacerbated when I lift or move my arm.
58 2021-03-25 cold sweat, pain in extremity 3/24, 8 a.m. shot 5p, right arm was a little sore 6p, right arm, shoulder, and neck could not move 8... Read more
3/24, 8 a.m. shot 5p, right arm was a little sore 6p, right arm, shoulder, and neck could not move 8p, massive chills all through the night. 3/25, 6a, clammy, whole body sore, back ache, headache 7a, massive chills again, went back to bed. 11a, then a slight fever all day, stayed in bed 5p, chilled again. laid on couch all day until going to bed 3/26, Morning started out foggy, arm hurts just a bit, by my back aches terrible. Hoping by 3/27, I am back to normal.
58 2021-03-25 pain in extremity, weakness Arm still sore,. dizzy, feet and ankles swollen, stomach hurts, all my muscles hurt,. headac... Read more
Arm still sore,. dizzy, feet and ankles swollen, stomach hurts, all my muscles hurt,. headache,. nausea,. feel tired no energy
58 2021-03-25 throat numbness Within a minute or receiving the COVID 19 vaccine I began experiencing tingling and numbness in my l... Read more
Within a minute or receiving the COVID 19 vaccine I began experiencing tingling and numbness in my lips, tongue, mouth and throat. My throat felt like it was closing or tightening and I had difficulty swallowing. I was administered Benadryl at the vaccine site and then transported by ambulance to the Hospital. There I was given an IV with peptide, steroid and benadryl. After a couple of hours, my symptoms began to improve and I was released. I continued to experience irritation of my tongue and mouth and a sore throat until the next day.
58 2021-03-25 tenderness Breast swollen, red and hot to the touch. This is the area where I previously had radiation. Area ... Read more
Breast swollen, red and hot to the touch. This is the area where I previously had radiation. Area where lymph nodes were removed were sore and tender
58 2021-03-26 flushing flushed and feeling lightheaded, patient waited extra time and left after improvement.
58 2021-03-26 pain in extremity Trouble sleeping during night, achey legs started around 6am and continued throughout day along wit... Read more
Trouble sleeping during night, achey legs started around 6am and continued throughout day along with some chills, fever of 100.6, headache. Fully better by next morning.
58 2021-03-27 tingling, numbness Right foot experiencing periodic tingling and numbness. Right leg is compromised due to Diastamatomy... Read more
Right foot experiencing periodic tingling and numbness. Right leg is compromised due to Diastamatomylia.
58 2021-03-28 difficulty speaking pt states that her ears started itching and became red. She noticed her back, legs, and arms were r... Read more
pt states that her ears started itching and became red. She noticed her back, legs, and arms were red and very itchy. She says her skins is raised like a rash. Her voice became strange and she lips were swollen. She went to bed and when she got up her lips were more swollen. She took Benadryl for her symptoms and went back to bed. She says she has some itching but feels like she seems to be improving.
58 2021-03-28 numbness, flushing Burning upon injection. After a few minutes the burning went down left arm. Then left cheek starte... Read more
Burning upon injection. After a few minutes the burning went down left arm. Then left cheek started to feel numb and flushed. Left cheek started swelling. Headache. Throat scratchy. Chest pain started 20 minutes after shot. Left arm felt heavy. Throat started to feel tight just before benadryl was given. Benadryl helped relieve the throat symptoms and the face swelling and numbness subsided.
58 2021-03-28 numbness Pt received vaccine 0927. 0940 Pt c/o numbness to lips and lower face, slight pinkness noted to b ch... Read more
Pt received vaccine 0927. 0940 Pt c/o numbness to lips and lower face, slight pinkness noted to b cheeks and neck. Pt initially stated swelling in neck, but symptom resolved and pt denies now. Pt given Benadryl 25mg PO, additional OBS x 30 min. Pt co-worker picked her up and left @ 0955 with pt stating she felt better. RN
58 2021-03-28 muscle spasms 3/26 @ 2:30 Abdominal cramping for one hour, followed by 2-3 hours of diarrhea. Overnight had muscl... Read more
3/26 @ 2:30 Abdominal cramping for one hour, followed by 2-3 hours of diarrhea. Overnight had muscle cramping in legs. 3/27 Fatigue & overall feeling of distraction. Poor appetite. Headache started in back of head. That evening had joint aches in hips, knees, shoulders, wrists & hands. Then awoke after one hour of sleep with uncontrollable shaking chills, followed by severe nausea and vomiting that lasted most of the night. Also felt feverish, but didn?t take my temperature until late afternoon on 3/28, it was 99.6 orally. Could not tolerate intake of solids without severe queasy feeling. 3/29 Feel exhausted & weak. Still feeling queasy with solid food. My injection site @ left upper arm was very sore until 3/29. Soreness mostly resolved.
58 2021-03-28 numbness and pain in extremities, facial pain, pain in extremity slight neuropathy in fingers; Very itchy - almost painful itchy zings in my elbow area, face and leg... Read more
slight neuropathy in fingers; Very itchy - almost painful itchy zings in my elbow area, face and legs; Very itchy - almost painful itchy zings in my elbow area, face and legs; Very itchy - almost painful itchy zings in my elbow area, face and legs; Very itchy - almost painful itchy zings in my elbow area, face and legs; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Mar2021 11:15 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation at a Pharmacy or Drug Store. The patient has no medical history. The patient has no Covid prior to vaccination. The patient had other medications in two weeks but no other vaccine in four weeks. On 13Mar2021 11:30, the patient experienced very itchy, almost painful itchy zings in her elbow area, face, and legs. The patient also had some slight neuropathy in fingers. This has continued for three days and started immediately after receiving the vaccine. The patient was not tested for Covid post vaccination. The events were not treated. The outcome of the events was not recovered.
58 2021-03-28 pain in extremity Slight aches especially in lower back and legs but only lasted for a few hours the day after my vacc... Read more
Slight aches especially in lower back and legs but only lasted for a few hours the day after my vaccine
58 2021-03-29 muscle spasms, pain in extremity "pressure" headache, fever of 100.3, calf and feet cramps, sore arm (injection site) . Slept most of... Read more
"pressure" headache, fever of 100.3, calf and feet cramps, sore arm (injection site) . Slept most of day. Woke up to slight soreness in arm, no fever, muscles back to normal, "pressure headache" until noon, then okay.
58 2021-03-29 tingling Tingling, pins and needles feeling in torso, neck, ears, jawline, arms, wrists and hands. Took Bene... Read more
Tingling, pins and needles feeling in torso, neck, ears, jawline, arms, wrists and hands. Took Benedryl and can still feel it in jawline, hands and forearms. No rash or hives present. Will discuss with PCP regarding getting 2nd dose
58 2021-03-30 weakness Fatigue, body aches/weakness and general flu-like symptoms with fever of about 101. Fever came on a... Read more
Fatigue, body aches/weakness and general flu-like symptoms with fever of about 101. Fever came on about 24 hours after vaccination.
58 2021-03-30 nerve pain, pain in extremity On day 11 after my 1st vaccine my body joints ached like never before from my toes to my ears. I am... Read more
On day 11 after my 1st vaccine my body joints ached like never before from my toes to my ears. I am not 100% sure the pain level had gotten some what better or if the Aleve that I added to my daily meds for this joint pain, & the OxyContin I take on a daily basis for the past 18 years is masking it more. It is making my hands feels so sore like I assume someone with Arthritis feels. I also get nerve shooting pains in my thumbs & right arm. My question is; is this a reported side effect? If yes, how long does it last & should I get the 2nd vaccine.
58 2021-03-30 pain in extremity tired; nauseous; headache; her arm was sore; This is a spontaneous report from a contactable consume... Read more
tired; nauseous; headache; her arm was sore; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer-sponsored program COVAX Support. A 58-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 around 12:20-12:30 (at 58 years old) as single dose for covid-19 immunisation. Medical history included ongoing atrial fibrillation, anxiety, underactive thyroid and cholesterol. Concomitant medications included paracetamol (TYLENOL EXTRA STRENGTH), via an unspecified route of administration on 23Feb2021 (Batch/Lot number Other: DAE30 could be an O 37A; Expiration Date: Aug2021, NDC number of Top Care Extra Strength Tylenol: 36800-484-71) at 1000mg, 2 caplets for headache and magnesium for atrial fibrillation. She does take other medicines, because she was in atrial fibrillation, she took extra of her atrial fibrillation medications. She also took magnesium. She took that every day anyway but sometimes she takes an extra pill or 2 to help go back to sinus rhythm if she was in atrial fibrillation. The patient also had an underactive thyroid. She took a very low dose medicine for cholesterol only 10 mg. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/lot number: EN6198) intramuscular injection, left arm on 29Jan2021 (at 58 years old) and experienced atrial fibrillation and headache. The patient previously received the second dose of the varicella zoster vaccine. Illness at vaccination included atrial fibrillation and headache. Before getting the vaccine on 23Feb2021 she had a bad headache, and so she took 2 extra strength Tylenol a couple of hours before receiving the 2nd dose of the vaccine. The patient experienced tired, nauseous, headache, her arm was sore on 23Feb2021. The patient recovered from tired, nauseous, headache on 24Feb2021, from arm sore on 26Feb2021. The events did not require an emergency room visit nor a physician office visit. The clinical course was reported as follows. The patient was in distress over this, she can't sleep or eat, experiences anxiety anyway but now she's worried that she's not as protected because she took the Tylenol before the second dose of the vaccine. The patient reported that on 22Feb2021 at 10PM her atrial fibrillation started. The atrial fibrillation was still going on when she went to get the dose, when she got the dose, and even after she got the dose. The atrial fibrillation didn't go away until that evening, 23Feb2021 around 5-6pm. Then she went back to sinus rhythm. After she got home from getting the Covid 19 vaccine she took a shower she didn't feel good. She was tired but she didn't sleep the night before because she was in atrial fibrillation and was exhausted. Because she didn't sleep much she doesn't know if the tiredness was from the vaccine or atrial fibrillation. She reported an headache but she stated she may have had a headache before because she got headaches and took Tylenol, but thought she had after too. She ate breakfast then she didn't eat until dinner time and she felt nauseous. She felt more nauseous, she didn't throw up and she took Tylenol again that evening on the 23Feb2021. When she woke the next day on 24Feb2021 she got nauseous again but after the second day she didn't have nausea anymore. She wasn't sure if the nausea was from the vaccine. She's not positive. She just felt under the weather, but no fever or anything. She's a very anxious person and very worried. She reports her arm was sore, did not see any swelling or anything for 2 or 3 days. She feels pretty good today, back to normal. Information on the lot/ batch number has been requested.
58 2021-03-30 pain in extremity sore left arm; got chilled; head was throbbing; temperature was 103 but went down a little bit; felt... Read more
sore left arm; got chilled; head was throbbing; temperature was 103 but went down a little bit; felt lightheaded; This is a spontaneous report from a contactable consume (patient herself). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (at the age of 58 years) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that she got the first shot of Pfizer yesterday afternoon. In Feb2021, she had a sore left arm. She stated that 2-3 hours ago that she got chilled and her head was throbbing. Her temperature was 103 but went down a little bit. She felt lightheaded when she was doing lunches for daycare. She stated that she was not lightheaded anymore. She knew that it was normal. She went to check in online but cannot do it right. She stated that she took an ibuprofen 40 minutes ago. She wanted to know if this was normal. Outcome of felt lightheaded was recovered in 2021, outcome of other events was unknown. Information about lot/batch number has been requested.
58 2021-03-30 pain in extremity sore left arm; chilled; head was throbbing; temperature was 103 but went down a little bit; lighthea... Read more
sore left arm; chilled; head was throbbing; temperature was 103 but went down a little bit; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore left arm, chilled, head was throbbing, temperature was 103 but went down a little bit, and lightheaded; all in Feb2021. Clinical course: The patient stated that she got the first shot of Pfizer vaccine yesterday afternoon. She stated she had a sore left arm, 2-3 hours ago she got chilled and her head was throbbing. Her temperature was 103 but went down a little bit. She felt lightheaded when she was doing lunches for daycare. She was not lightheaded anymore. She knew that it was normal. She went to check in online but cannot do it right. She took an Ibuprofen 40 minutes ago. The outcome of event temperature was 103 but went down a little bit was resolving, outcome of event lightheaded was resolved in Feb2021, outcome of other events was unknown. Information on the lot/batch number has been requested.
58 2021-03-30 pain in extremity Ache and pain in the bicep and forearm. Pain got worse after 2nd dose on 1/16/21. No other side effe... Read more
Ache and pain in the bicep and forearm. Pain got worse after 2nd dose on 1/16/21. No other side effects, just arm pain. It continues today, did not have pain prior to injection.
58 2021-03-30 pain in extremity Patient felt pressure on chest & weakness on inside of left are in the bicep area shortly after gett... Read more
Patient felt pressure on chest & weakness on inside of left are in the bicep area shortly after getting up at 6 am 3/29/2021. Slight light-headedness was felt shortly afterwards. Symptoms did not change after moving around & on the advice of patient's insurance company's Nurse Line, she went to the Emergency Room shortly after 7 am. Patient underwent a heart catheterization that day (3/29/2021) and a cardiac MRI the following day (3/30/2021). Cardiologist informed patient he suspected either Stress Cardiomyopathy or Myocarditis. Patient was discharged 3/31/2021 with 4 medications and follow-up appointments scheduled
58 2021-03-30 tingling, numbness numbness, tingling and swelling on the right side of face and head down right arm and chest; numbnes... Read more
numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), via an unspecified route of administration on 08Mar2021 at 11:15 (at the age of 58 years) at a single dose in the right arm for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included irbesartan; nifedipine; spironolactone; and estradiol. The patient did not receive any other vaccines within 4 weeks prior COVID vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not pregnant at the time of vaccination. On 08Mar2021 at 11:30, the patient experienced numbness, tingling and swelling on the right side of face and head down right arm and chest. The events resulted to Emergency room/department or urgent care visit. The patient was hospitalized on an unspecified date due to the events. Patient was given Benadryl antihistamine w/IV Cat-Scan other work up as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
58 2021-03-31 weakness, tingling, numbness Dizziness & weakness, N/T. "Severe headache. My worst day was 8 days after shot. But I felt like I... Read more
Dizziness & weakness, N/T. "Severe headache. My worst day was 8 days after shot. But I felt like I had the flu. Also could not focus. Felt like I had memory loss. Had a covid test to make sure I did not have that
58 2021-03-31 feeling hot Feverish feeling in face, slightly dizzy , felt like nodes under left side of chin were getting tigh... Read more
Feverish feeling in face, slightly dizzy , felt like nodes under left side of chin were getting tighter, i.e., labored breath slightly, felt like heart was racing for a few seconds. Sat down and waited for 10 minutes. Feelings subsided. Did not report this to the pharmacist.
58 2021-03-31 flushing, numbness client complained of numbness to lip after receiving the 1st COVID (lot # EW 0150, exp. 4/3/21) at... Read more
client complained of numbness to lip after receiving the 1st COVID (lot # EW 0150, exp. 4/3/21) at 1150. Client signaled PHN and informed her she was starting to feel her left lip going numb, pressure to her lower base of the head and palpitations. First set of vitals:blood pressure 140/80, pulse 80, oxygen 98%. Client alert and oriented with flushed skin. Client denied shortness of breath , chest pain, no swelling at this time. PHN offered client Benadryl, per client would call friend first if medication was given so she could be picked up. History of anxiety and hypertension, per client had an allergic reaction to flu shot in the past. Current medication: losartan. At 1200 client stated numb sensation was radiating to left cheek PHN offered client Benadryl again and client accepted. 50 mg/IM Benadryl administered to right deltoid at 1203. Client informed we would keep her for further observation and would take vitals every 5mins. Vitals at 1205: pulse 94, blood pressure 180/95 oxygen 97%. Numbness to lip and face same, pressure to head same, palpitations same. Alert and oriented. Vitals 1210: blood pressure 120/80, pulse 81, oxygen 100%. Per client previous complaints improving. Client stated could feel cheek again. Vitals 1215: blood pressure 140/80, pulse 102, oxygen 99%. Client stated feeling nausea, emesis bag given and water. Per client also starting to feel drowsy. Palpitations improving and more sensation to lip area. At 1219 client stated having chills, palpitations returning. Per client was not sure if it was her anxiety. PHN offered 911, get paramedics for further assessment and to transfer to hospital for higher level care. Client refused, she felt benadryl was helping at this time. Vitals 1221: blood pressure 140/80, pulse 87, oxygen 99. Client stated all complaints improving. Vitals 1228: blood pressure 142/80, pulse 80, oxygen 100%. Vitals 1234: blood pressure 140/90, pulse 78, oxygen 99%. Per client lip and cheek no longer numb, normal sensation. Nausea had resolved and palpitations improving. 1241 vitals: blood pressure 140/90, pulse 80, oxygen 97%. Vitals 1247: blood pressure 130/90, pulse 75, oxygen 100%. Client stated feeling good. All complaints had resolved. Per client just tired feeling. 1257 vitals: 130/90, pulse 78, oxygen 96. No complaints. Client advised to speak with primary doctor prior to second dose. ER precautions given. Friend arrived at 1300 and would drive client home. last set of vitals 1305: blood pressure 130/90, pulse 75, oxygen 98. All symptoms resolved. Client left facility with a steady gait at 1307
58 2021-03-31 night sweats Started with light headedness and fatigue. three days later developed vertigo, headache, nausea, he... Read more
Started with light headedness and fatigue. three days later developed vertigo, headache, nausea, heart palpitations, night sweats.
58 2021-03-31 pain in extremity, migraine Sore arm, migraine, fingers swelling
58 2021-03-31 pain in extremity I woke up throughout the night first night with left arm very sore feeling like an elephant trunk. I... Read more
I woke up throughout the night first night with left arm very sore feeling like an elephant trunk. In AM I woke up and felt ill. Throughout the day my temperature went up to 102 by the afternoon. I had headache, bad muscle pain and aches and generally felt miserable. Also, the gland under my arm pit was extremely swollen for 3 full days the size of a baseball. It hurt to rest my arm to my side. That second night, I took fever reducer before I went to bed. Fever broke and I soaked through 3 pairs of pjs. The next day my fever went up to 100.7. I didn't take any more fever reducer. Third day it went up to 99.7. Fourth day normal temp but then I had extreme fatigue starting fourth day to where I barely had energy to sit up or even walk to the bathroom. I tried to do my online remote work that week but only worked 1/3 my schedule due to extreme fatigue. One day I was in the kitchen and had to drop to the floor and rest to get enough energy to walk back to my bedroom. The extreme fatigue lasted a good 5-6 days then the following week I pushed through my online work without reducing my hours but would go straight to bed right afterwards due to fatigue. I have struggled with Epstein Barr virus since I was 23 and get fatigued after getting strep or exercising too much or other illnesses so chalked it up to the EBV. I still had minor stabbing pain under my armpit until the past couple of days. My energy is now back to normal.
58 2021-04-01 weakness 3 Hours of Chills, 5 days of nausea, 12hrs of vomiting, 3-4 days fever, low energy. Minimal arm pai... Read more
3 Hours of Chills, 5 days of nausea, 12hrs of vomiting, 3-4 days fever, low energy. Minimal arm pain at injection site, but random shooting pain at injection site very infrequently.
58 2021-04-01 weakness 3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours afte... Read more
3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours after vaccination - chills, body ache, headache, lethargy. 3/23/2021 - woke with nausea and anorexia, took triple usual hydrocortisone dose (30mg) with yogurt, very lethargic, brain fog with cognitive difficulty, anorexia, stayed in bed all day, eating drinking veyr little. 3/24/2021 - woke with worsening lethargy, generalized weakness, nausea, took hydrocortisone 30mg with yogurt. by noon, very dizzy and weak, unable to get out of bed, friend drove her to Hosp. Emergency Room. Noted hypotension systolic BP 80, clinically dehydrated, Na 129, K 3.2, cr 1.2 (nl 0.97) Diagnosed Adrenal Crisis admitted 3 days to 3/27
58 2021-04-01 facial paralysis Headache started on 3/24/21. Two days later, patient experienced facial droop. Told to go to ER. ... Read more
Headache started on 3/24/21. Two days later, patient experienced facial droop. Told to go to ER. Of note, patient reports childhood history of polio.
58 2021-04-01 numbness On Monday Morning 3.29,21 about 9 am started to develop additional numbness in half of my palm on ... Read more
On Monday Morning 3.29,21 about 9 am started to develop additional numbness in half of my palm on left hand under ring and pinky, wrist, elbow, arm pit. sore and throbing at time. Nerve going down my are feels tight and pinched.
58 2021-04-01 numbness Persistent shoulder pain. Injection administered too high in shoulder. Perhaps into bursa. Very pain... Read more
Persistent shoulder pain. Injection administered too high in shoulder. Perhaps into bursa. Very painful for the first two days, then pain diminishing, but on day four, inflamation in shoulder joint. Saw my Dr, who suggested that this is suspicious for improper vaccination technique. Recommended that I make a report. Symptoms, pain in shoulder joint and over scapula, down back side of left arm. Numbness in the morning in hand, resolving as day passes. Will begin physical therapy week of 4/6.
58 2021-04-01 numbness Numbness in both hands. Still able to completely function - just annoying. Has lasted about a week t... Read more
Numbness in both hands. Still able to completely function - just annoying. Has lasted about a week thus far.
58 2021-04-01 migraine, weakness, numbness Right ear had odd sensation, headache that became migraine, difficulty breathing, lightheadedness/fa... Read more
Right ear had odd sensation, headache that became migraine, difficulty breathing, lightheadedness/faintness, numbness on right side. Also had flu like symptoms.
58 2021-04-01 pain in extremity 1/15 vaccination I didn't have any problems except a super sore arm. Tuesday afternoon, I had a ras... Read more
1/15 vaccination I didn't have any problems except a super sore arm. Tuesday afternoon, I had a rash, super bright red, that covered where clothing was under my scrubs on my legs, partly on arm. Lasted until Friday afternoon, 1/22. Hives plus red areas. It did expand to my face, beyond where clothing was. It was not itchy, swollen uncomfortable. 1/22 Dermatologist. They took pictures and compared to the pictures online with the CDC. The doctor stated I should not take any more vaccines based on what we know right now with the vaccines. I did go see an allergist. Dr. stated needed pics and notes. And she said yes, you should NOT have any more vaccinations. I kept taking the Zyrtec for week and half.
58 2021-04-01 pain in extremity pain and muscle weakness and strain down both my arms and elbows - sporadic body aches and pains all... Read more
pain and muscle weakness and strain down both my arms and elbows - sporadic body aches and pains all over - pain at injection site, neck, headaches. My muscles also feel very weak. I feel my strength is not the same in my muscles and joints, I seriously sprained my ankle just moving and it just feels like my body is weak and vulnerable since the shot.
58 2021-04-01 pain in extremity Moderate Body aches Arm soreness Extreme Fatigue Low Pressure on chest
58 2021-04-01 pain in extremity Patient experienced some dyspneo after vaccination.. Pain radiated down arm. Onsite EMS called HR 1... Read more
Patient experienced some dyspneo after vaccination.. Pain radiated down arm. Onsite EMS called HR 107 BP 200/91 100% O2 , patient recovered and went home.
58 2021-04-02 numbness, tingling Tingling in area above breast and heart then Heart rate and blood pressure increased. Metal taste i... Read more
Tingling in area above breast and heart then Heart rate and blood pressure increased. Metal taste in mout. Face and lips went numb. Ears ringing loud. Dr at vaccination site. Stayed I was having an antihistamine reaction and she needed to cool my body and the blood to my brain down. She iced my jugular on both sides of my neck for 20 minutes in vehicle with the window down and the ac on high. It was quite cool. Heart rate downed and Metal taste disappeared. Face got some feeling back. Lips still were particularly numb. She released me to go home after 3:45pm. Tired, headache that night. Next day 4/2 tired, headache and diarrhea all day. Ears ringing 4/3 slight headache , ears better. Diarrhea gone
58 2021-04-02 pain in extremity, weakness Day 1 (started about 5 minutes post-inoculation) lightheadedness (Short-lived, about 5') Day 1 (A f... Read more
Day 1 (started about 5 minutes post-inoculation) lightheadedness (Short-lived, about 5') Day 1 (A few hours later): lightheadedness headache Low energy Arm pain & Hand pain (same arm as where inoculation took place) Day 2: headache not persistent Low energy Arm pain (same arm as where inoculation took place) Day 3: headache not persistent generally tired Upper Arm pain (same arm as where inoculation took place)
58 2021-04-02 pain in extremity, tenderness Right after injection, prickly and pinchy at site of injection and almost immediate arm soreness. A... Read more
Right after injection, prickly and pinchy at site of injection and almost immediate arm soreness. Arm soreness remained the rest of the day 4/1/21. On 4/2/21, muscle and joint aches and pain increased and reached full intensity by 7:00pm. Upset stomach intermittent unproductive nausea. All joints hurt with movement (including knees, toes, shoulders, ankles). All muscles hurt (including calves, stomach muscles, chest front and back, breasts, fingers, lower back, shoulders, neck...etc). Skin was extremely and uncomfortably sensitive to touch. Serious fatigue accompanied the muscle aches and pains. Advil/Tylenol did not help. On 4/3/21 awoke with milder overall muscle pain, though still present. Minor Fatigue.
58 2021-04-02 tenderness Around ten and a half hours after my injection, I started to experience extreme fatigue. Went to be... Read more
Around ten and a half hours after my injection, I started to experience extreme fatigue. Went to bed and woke up an hour later to a severe headache. Through the night I had fever (100.7), chills, muscle aches which kept me up all night. Around 1:00 pm the following day I finally started to feel better. Rested throughout the day and slept fine that evening. The next day I woke up with a swollen lymph node under the armpit of my left arm which received the vaccine. That tenderness went away around three days later.
58 2021-04-03 feeling hot, weakness Immediate drowsiness and weakness. Followed by nausea and hot sensations throughout body, which are... Read more
Immediate drowsiness and weakness. Followed by nausea and hot sensations throughout body, which are ongoing. Weakness is prevalent. Nausea is number 8 on scale of 1-10. Injection site is a number 10 considering all other injections and vaccinations I?ve ever had.
58 2021-04-03 flushing Flushed. BP 110/58 (pulse 78). O2 sat 98%.
58 2021-04-03 numbness, difficulty speaking allergic reaction; Face went numb; Hard to swallow; Voice got hoarse; Inside of her ears got very it... Read more
allergic reaction; Face went numb; Hard to swallow; Voice got hoarse; Inside of her ears got very itchy; Scalp also got itchy; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in the left arm on 24Feb2021 (Batch/Lot Number: EM9809) (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma since many years ago, but it was under control and fibromyalgia since many years ago. Concomitant medications included pregabalin at 250mg daily (100 mg once a day and 150 mg second part of the day) for fibromyalgia, budesonide, formoterol fumarate (SYMBICORT) inhalation powder, at 2 inhalations twice a day for asthma, escitalopram at 20mg tablet once a day for asthma, rosuvastatin calcium at 5mg tablet once a day for an unspecified indication, venlafaxine hcl at 50mg tablet twice a day for an unspecified indication, montelukast sodium at 10mg once a day for an unspecified indication and ciclosporin (RESTASIS) eye drops at one drop in each eye, twice a day for an unspecified indication. The patient was previously received the first dose of BNT162b2 (Lot number: EL9262), via an unspecified route of administration on the left arm on 03Feb2021 15:59 (at the age of 58-years-old) as a single dose for COVID-19 immunization and experienced tip of her tongue, lips, and part of cheek close to her mouth went numb on 03Feb2021, 45-60 minutes after the shot and the patient was recovered from the events on 03Feb2021 as they went away. Within 5 minutes after getting the vaccine shot on 24Feb2021, the patient had a much bigger allergic reaction and she experienced face went numb, it was hard to swallow, her voice got hoarse, the inside of her ears got very itchy and her scalp also got itchy. The patient was treated with diphenhydramine (BENADRYL) at 25mg tablet that night. The outcome of events, allergic reaction, face went numb, hard to swallow, voice got hoarse, inside of her ears got very itchy and scalp also got itchy was recovered on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122392 first dose
58 2021-04-03 pain in extremity Fever 100°, sore arms, back, legs, fingers, toes
58 2021-04-04 weakness I experienced a fever of 101.5 around 24 hours after receiving the vaccine, which stayed with me for... Read more
I experienced a fever of 101.5 around 24 hours after receiving the vaccine, which stayed with me for 4 days- going as high as 104.5. I was able to control with Tylenol/ Motrin, but fever did not go below 101.0 for the 4 days I was bedridden. I also experienced the following: Overall feeling of unwellness, Headache, chills, aches, sore injection site, weakness, nausea, severe diarrhea with bile, and coughing
58 2021-04-04 breast pain Right breast pain, first noticed on April 4th. 5pm. Took 1 advil, pain went away. Next day, 7pm, sa... Read more
Right breast pain, first noticed on April 4th. 5pm. Took 1 advil, pain went away. Next day, 7pm, same pain, same spot. This is after-weeks after- the 1st shot. 2nd shot date is April 14, at 11:15am
58 2021-04-04 burning sensation Myalgia, malaise, headache, burning pain in right axilla for 3 days. Then, lymphadenopathy in right ... Read more
Myalgia, malaise, headache, burning pain in right axilla for 3 days. Then, lymphadenopathy in right axilla
58 2021-04-04 feeling cold Chills, headache, tired, chest hurt on and off.
58 2021-04-04 feeling hot, feeling cold Flu like symptoms with headache, body aches, hot and cold spells, nausea, just overall don't feel we... Read more
Flu like symptoms with headache, body aches, hot and cold spells, nausea, just overall don't feel well
58 2021-04-04 night sweats, tenderness, pain in extremity At approximately two and half hours after dose extreme headache every hour for 1min. Took Ibuprophen... Read more
At approximately two and half hours after dose extreme headache every hour for 1min. Took Ibuprophen. Night sweats, no chill or fever. Following morning headache continued. Took Ibuprophen. Very congested but that may have been from the allergy from the pollen. Sore arm with slight bump. Very fatigue after 5:30 pm. Woke up to another bout of night sweats, 3"x1-1/2" rash bump 1 inch below injection site. Very tender left armpit extending to left outside breast. Will continue to monitor site and will report to physician if symptom continue to worsen. Pictures were taken on my phone for comparison.
58 2021-04-04 night sweats Full body aches, fever of 101.1, chills, headache, fatigue, night sweat. These all started about 10 ... Read more
Full body aches, fever of 101.1, chills, headache, fatigue, night sweat. These all started about 10 pm the day of the vaccine and was better Monday 4/5/21
58 2021-04-04 pain in extremity Slight elevation in body temperature, chills, headache, doped up feeling, legs, ankles and feet hurt... Read more
Slight elevation in body temperature, chills, headache, doped up feeling, legs, ankles and feet hurt on right and left side. Shot was given in right arm but my left arm felt like it had the shot in it also. Arm pain where shot was given.
58 2021-04-04 seizure, feeling hot, muscle spasms Monday, April 5, 2021 Thank you for this opportunity to share my experience. Healthy, no underlyi... Read more
Monday, April 5, 2021 Thank you for this opportunity to share my experience. Healthy, no underlying conditions, active, On Saturday, March 27th at around noon, I had my 2nd Pfizer vaccine, administered in my right arm at the The injection was painless, I had zero symptoms initially following the injection and none the rest of that day. On Sunday, upon waking, my arm was uncomfortable but not painful. No symptoms on Sunday. On Monday, upon waking, my arm was more uncomfortable, I felt a little off; minor headache, minor light headed feeling, so I took 2 Tylenol. On Tuesday, upon waking, my arm was very painful at the injection site. It was difficult to raise my arm above my shoulder. I did not take any Tylenol although I still felt a little off. I massaged the injection site. We have a brand new 2021 hot tub that we use daily so I got in and positioned my right arm injection site on a bubbly jet to massage the area. It helped alleviate the severe pain and muscle stiffness. I had an English muffin, 1 poached egg and banana, I showered, got dressed and my husband and I went to the bank and to store. While in store, around 12:30 ? 1:00 PM, I began to feel light headed, very hot; not a fever hot, just very temperature hot. I told my husband I needed to leave NOW. He got me a cold water and we left. Upon arriving home ? say 20 minutes later, I was very light headed and nauseous. I went directly to bed to lie down. By 2:00 PM, my nausea was extreme as I laid in bed. I knew I would feel better if I could throw up, but I also knew I would have to make my self do it because it wasn?t happening on it?s own. I went to the bathroom and began to put my finger near my mouth and that?s all it took and I violently vomited 3 times. The vomit was liquidy, and old blood red. Remember, for breakfast I had had a dry English muffin, poached egg and banana. NOTHING red! I screamed for my husband who came in and was shocked to see the color and volume of vomit. He helped to clean me up and help me back to bed, where I immediately returned to the bathroom with severe diarrhea?the same old blood red color. Again, he helped to clean me up and help me to lie down. He got me cool water which I sipped. Within an hour, I rushed back to the bathroom and VIOLENTLY threw up again. Severe convulsions, unable to breath in between each convulsion. Old blood red, liquid, and to make matters even worse, the same color liquidy diarrhea. This went on for another 20 minutes. My husband was with me the entire time as the extreme convulsions contorted me and I could not keep aim to the toilet. I thought I had internal bleeding and was dying! I have never been this sick!!! Again, he cleaned me up, helped me back to bed where I was exhausted. He encouraged me to sip cool water which I did. On Wednesday morning upon waking, I was less nauseous. My husband urged me to try a dry English muffin (my normal morning routine). I was able to eat a few bites and keep them down. I showered to clean myself up and that did me in. I made it to the couch for the day. Sipping water and trying to complete the dry English muffin. On Wednesday I did not have a bowel movement. On Thursday morning upon waking, I was less nauseous and was able to drink a cup of tea and finish a dry English muffin. On Thursday I did not have a bowel movement. On Friday morning upon waking, I was not nauseous. I was able to drink a cup of tea and finish a dry English muffin and 1 poached egg. On Friday I did not have a bowel movement. On Saturday, now 1 week following the injection, I was better. Able to shower, able to eat, able to get out of the house. I had a small bowel movement that was the same dark color but somewhat in tact. On Sunday, Easter, I felt really good. Ate breakfast, lunch and dinner. Had a better bowel movement; not dark but ?my? normal color and condition. My theory (and I am not a scientist or medical person in ANY way!!!). When my arm was SO painful at the injection site and I got in the hot tub and placed my arm on a bubbly jet, it?s like I released the full burst of vaccine ? like a bolus ? into my system, rather than letting the muscle spasm release allowing the vaccine to gently circulate through my body. In July and I can assure you that in my all of my years of owning this body, I have NEVER experienced any flu or sickness with this severe or this violent convulsing vomiting and NEVER experienced the color of the contents!!!! My husband, with no underlying conditions, has also had both of his shots. He had no side effects. Yeah!! Since this experience, I have not been able to drink coffee or wine, of which both were a regular part of my diet. Now on a lighter note, less coffee and wine isn?t a bad thing, however since this episode I cannot fathom the thought of either of those entering my system. Thank you again for this opportunity to share my experience. I am glad to have both shots and I hope I am NEVER this sick again!!!!
58 2021-04-04 unresponsive to stimuli 4am, 4/3/21, chest pain unresponsive to 2 chewed Gaviscon. 5 baby ASA taken po and drove to hospita... Read more
4am, 4/3/21, chest pain unresponsive to 2 chewed Gaviscon. 5 baby ASA taken po and drove to hospital ED at 4:30am. First EKG negative for changes. First tryponin lab 0 and negative. Approximately noon, 2nd tryponin elevated at 0.54. Right radial access heart catheterization at approximately 1pm shows small branch of LAD with SCAD. Medical management with IV heparin, Plavix, and daily baby ASA 81mg. Discharged to home 4/4/21.
58 2021-04-05 discomfort Chills, pressure on chest and some breathing discomfort since the day after the first shot, i.e., st... Read more
Chills, pressure on chest and some breathing discomfort since the day after the first shot, i.e., starting on March 17, 2021
58 2021-04-05 flushing, pain in extremity very sore right arm - felt like was hit with a baseball bat - started around 5 hours after injection... Read more
very sore right arm - felt like was hit with a baseball bat - started around 5 hours after injection (8pm) and lasted for 36 hours fever started around 8 hours post injection (12 midnight) and lasted for 41 hours body aches mimicked the fever started around 8 hours post injection (12 midnight) and lasted for 41 hours fatigue started within 2 hours and lasted 48 hours flush in face started 68 hours post and is ongoing at this time
58 2021-04-05 numbness, feeling hot pt states that she got a strange feeling in the left side of her face. She had a hot streak across ... Read more
pt states that she got a strange feeling in the left side of her face. She had a hot streak across her ear and her face. She had some heat that she felt was moving through the left side of her body. Her left arm is numb from her elbow to her fingertips. Her left foot became numb. Her right foot has also become numb. She says it feels like her lips and her mouth are numb. Pt went to bed and when she woke up the numbness was getting worse. She contacted her PCP that instructed to go to the ER. She went to Medical Center ER on 4/1 /2021 where they treated her as a stroke patient. She was given MRI, CT, blood work. All tests were negative for stroke. She spent the night and then released to go home to FU w/ Neuro Dr. Pt saw Dr. and will do more blood work. She was told these symptoms would probably dissipate. Pt says she still has some numbness at this time.
58 2021-04-05 migraine Migraine headaches that woke me from sleep at the same time for four nights.
58 2021-04-05 pain in extremity Covid arm - rash, warmth, itch, swelling, pain sensation like "bee sting" Started 24-26h after vacci... Read more
Covid arm - rash, warmth, itch, swelling, pain sensation like "bee sting" Started 24-26h after vaccine On day 2 of rash now
58 2021-04-05 throat numbness, numbness 40min after receiving her second Pfizer vaccine, pt reported numbness on left side of tongue, down n... Read more
40min after receiving her second Pfizer vaccine, pt reported numbness on left side of tongue, down next and into upper chest.
58 2021-04-06 weakness Patient felt fatigue day one, then fever day two, then developed weakness and blurred vision, went t... Read more
Patient felt fatigue day one, then fever day two, then developed weakness and blurred vision, went to see eye doctor a few days later, was recommended to come to pcp due to eye findings, pt went home and checked sugar which glucometer read HI, which prompted her to go to er because this has never happened to her before
58 2021-04-06 weakness Nausea; Vomiting; Achy muscles and joints; Achy muscles and joints; I had no energy; This is a spont... Read more
Nausea; Vomiting; Achy muscles and joints; Achy muscles and joints; I had no energy; This is a spontaneous report from a contactable consumer reported for self. A 58-year-old female patient (No pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:30 PM (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included lupus. The patient did not have covid prior vaccination, no covid tested post vaccination, and did not have Known allergies. Concomitant drug was reported as too many to list. The patient experienced nausea, vomiting, achy muscles and joints, and she had no energy on 25Mar2021 03:00 AM with outcome of not recovered. All events considered serious due to Disability or permanent damage. No treatment received for the events. This has lasted for 5 days as of this date.
58 2021-04-06 numbness Approximately 20 minutes after dose I experienced numbing and swelling of lips. Increased salivatio... Read more
Approximately 20 minutes after dose I experienced numbing and swelling of lips. Increased salivation and nausea and dizziness. I took a Benadryl and went to bed. When I woke the swelling had left. I felt great, almost "high" for the next 24 hrs. The following 24 hours after that i experienced extreme fatigue. My lips still feel a little odd. I had no other side effects, not even a sore arm.
58 2021-04-06 pain in extremity, flushing Swelling back of neck lasted 2 hours, arm pain for 24 hours: tiredness ongoing past 2 days; flushed... Read more
Swelling back of neck lasted 2 hours, arm pain for 24 hours: tiredness ongoing past 2 days; flushed face, but no fever. Headache 24 hours.
58 2021-04-06 pain in extremity Within a few hours my arm was so painful that I found it difficult to lift it and it remained that w... Read more
Within a few hours my arm was so painful that I found it difficult to lift it and it remained that way for 3 days. Approximately 10 hours after the injection I began to feel a racing heart, headache, body aches. I had difficulty sleeping the first night because I felt achy and my heart was racing as if I had too much caffeine. The next day, 20-24 hrs after the injection the body aches and racing heart continued and I felt nausea, chills and began with a fever of 100.5 The fever continued for approximately 20 hours and reached averaging 101.2 for several hours with a high of 101.6. I did not take any fever reducer/pain relievers. The fever and headache stopped the next day though the body aches, nausea, and racing heart continued for a few more hours.
58 2021-04-06 tingling, flushing About a half hour after receiving first dose (around 5:30??) my face, neck, chest & ears became flus... Read more
About a half hour after receiving first dose (around 5:30??) my face, neck, chest & ears became flushed; it felt like a bad sunburn & felt a bit prickly. I applied a cold cloth to these areas in hopes it would calm down, but it didn?t help so around 6:15 pm I took 25 mg of Benadryl and at 6:30 I decided to go back to the place I received the injection to get checked out. The doctor confirmed the reaction & told me to take another Benadryl and continue taking as needed, and to watch for swelling of the throat. She also recommended taking Tylenol for any aches & pains that she guaranteed would come due to the response I had. I was asked to stay a while for observation and then went home around 7:15pm. Once home, around 8:00 pm I started aching so I took one extra strength Tylenol & went to bed. Around 2:30am this morning (4/7) I took another Benadryl because I?m still had an occasional prickly feeling.
58 2021-04-06 tingling tingling sensation around the face, lips and throat--sensation of swelling of cheek--no swelling of ... Read more
tingling sensation around the face, lips and throat--sensation of swelling of cheek--no swelling of tongue, no CP or SOB IM 50mg Benadryl given and observed in medical tent for 60 minutes. Vitals stable, improved symptoms during the observation time.
58 2021-04-07 weakness Immediate soreness around the injection site that progressively got worse as the day went on. By 10... Read more
Immediate soreness around the injection site that progressively got worse as the day went on. By 10:30 pm the same day my joints in my upper body began to ache and I was cold. Slept seven hours and this morning woke up with intense pain at a #7 on a scale of 1-10 with 10 being the worst in every joint in my body with no energy. I took a Tylenol and a Advil and stayed in bed until noon and now the pain is at a #3 being worse at sacral iliac joints and the injection site.
58 2021-04-07 feeling hot Within 5 minutes of the shot, I experienced abdominal discomfort and felt nauseous and then felt a w... Read more
Within 5 minutes of the shot, I experienced abdominal discomfort and felt nauseous and then felt a warmth over my entire body. I also developed a very rapid heartbeat and palpitations. The pharmacist was notified of my condition. I waited 25 minutes before leaving. Over the next hour, I developed a headache and at about 5 PM another rapid heartbeat occurred. I took my BP. It was 171/94. 15 minutes later, my BP was 169/87. My normal BP is 120/72 and I do not have heart disease. I then decided to seek medical care at the ER.
58 2021-04-07 migraine Woke up with a migraine. Am on Aimovig but it broke through. Extreme head pain, sinus pain, light... Read more
Woke up with a migraine. Am on Aimovig but it broke through. Extreme head pain, sinus pain, light sensitivity, sound sensitivity, scent sensitivity. Took one Butal-ASA-Caff-CAP and 2 Sinus Pressure and Pain pills. It took about 12 hours for it and symptoms to go completely away.
58 2021-04-07 muscle spasms Dizziness 04/07/2021 & 04/08/2021 Tired 04/08/2021 Muscle Weakness 04/07/2021 & 04/08/2021 Muscle ... Read more
Dizziness 04/07/2021 & 04/08/2021 Tired 04/08/2021 Muscle Weakness 04/07/2021 & 04/08/2021 Muscle Cramps 04/07/2021 Lower Back Pain and Sides 04/07/2021 & 4/08/2021 Headache by Right eye 04/07/2021 Burning in left shoulder to the side of my neck 04/06/2021
58 2021-04-07 pain in extremity, numbness, feeling hot Soreness in upper arm started at 6 PM. Warm rush of feeling starting from arm to neck and rising to ... Read more
Soreness in upper arm started at 6 PM. Warm rush of feeling starting from arm to neck and rising to the head. Not uncomfortable just notably not usual for me. Left ear started ringing and lasted for 10 minutes and just went away. The left side of my face feels slightly numb but OK. The strangest thing was I thought someone was just standing next to me and sticking something in my ear as a joke. I only live with my mother of 87 so this idea is preposterous but the feeling of something swimming and moving and going inside my ear was so strong I actually used a Q Tip to make sure there wasn't a bug going in there. it stopped after 5 minutes but it was the weirdest thing ever. It reminded me of when you get your ears cleaned and the doc puts something (cleanser - peroxide for instance) in it. GOD I'm glad it stopped because there is NO WAY I would be able to sleep with that. Now its fine. I hope it never comes back.
58 2021-04-07 pain in extremity Sore arm (injection site muscle aches/achiness joint pain chills low-grade fever (99.9) slight heada... Read more
Sore arm (injection site muscle aches/achiness joint pain chills low-grade fever (99.9) slight headache Treatment - Advil (2 pills 1X) & sleep Outcome - back to normal the next day and happy to be protected against COVID!
58 2021-04-07 pain in extremity Pain in upper left arm. The pain increases when I go to lift my arm
58 2021-04-07 tenderness Chills (possibly before I realized I was having side-effects) Extreme Fatigue Extreme Muscle Sorenes... Read more
Chills (possibly before I realized I was having side-effects) Extreme Fatigue Extreme Muscle Soreness (hurt to touch my own body, to sit, to lay) Extreme Joint Pain (swollen hands from trying to use computer)
58 2021-04-08 breast pain 24 hours after receiving the shot I started to feel achy, tired, and got the chills. That lasted to... Read more
24 hours after receiving the shot I started to feel achy, tired, and got the chills. That lasted to the next morning and then I had pain in my left arm pit near my lymph nodes and breast. This pain went away in a day or two.
58 2021-04-08 nerve pain Extreme increase in neuropathic pain refractory to medications that continues to this day. Other my... Read more
Extreme increase in neuropathic pain refractory to medications that continues to this day. Other myalgias, fatigue related to second dose have resolved.
58 2021-04-08 pain in extremity, flushing, tingling Approx 3 minutes after injection I experienced flushing, tingling in my tongue, throat esophagus and... Read more
Approx 3 minutes after injection I experienced flushing, tingling in my tongue, throat esophagus and stomach. It started in the back of my throat and spread quickly. Through my upper torso. I had no pain, no apparent swelling, no difficulty breathing. Just stinging/tingling throughout my upper torso, throat and mouth. It gradually subsided after about 30 minutes. I had no reaction at all to the first shot. I am now 48 hours out from the second injection and have a very sore arm, headache, body aches and low grade fever. All are relatively mild and are resolved with Tylenol.
58 2021-04-08 speech disorder, pain in extremity Dizziness, lightheaded, struggling to find everyday words when speaking. This occurred an hour or s... Read more
Dizziness, lightheaded, struggling to find everyday words when speaking. This occurred an hour or so after the vaccine. Right arm was very sore for 24 hours. The following day (Wed, April 7) while I was putting gas in my car, I had a strange experience. I was in the car, which was in park. I felt as though the car was moving as I was sitting in it at the pump. I kept holding down the break, but then realized I was still in the same spot. Very disturbing sensation. Since that day I have experienced periods of faster heart rate, dizziness, lightheadedness, and vertigo.
58 2021-04-08 tremor First started with headache, nausea, then had chills, shakiness swollen tongue, metallic taste, num... Read more
First started with headache, nausea, then had chills, shakiness swollen tongue, metallic taste, numb lips, tongue felt as if it had been burned, blurred vision, SOB, fatigue.
58 2021-04-09 weakness Adult female had just received her first dose COVID-19 vaccine, and proceeded to observation area. ... Read more
Adult female had just received her first dose COVID-19 vaccine, and proceeded to observation area. She became weak and faint. Onsite EMS station in observation area evaluated and transported patient to Emergency Room. Patient was awake and alert at time of transport.
58 2021-04-09 bell's palsy left side bell's palsy symptoms
58 2021-04-09 feeling hot, feeling cold Sore arm at injection site. Unable to sleep. Feeling cold followed by being too warm and back and fo... Read more
Sore arm at injection site. Unable to sleep. Feeling cold followed by being too warm and back and forth between the two. Nausea. General feeling of malaise.
58 2021-04-09 numbness Soreness in left arm from the injection location down to hand with some numbness in elbow and finger... Read more
Soreness in left arm from the injection location down to hand with some numbness in elbow and fingers. Visited my doctor on 4/8/2021 who believed problem was a reaction to the injection and prescribed pain pills and a sleeping aid.
58 2021-04-09 pain in extremity After the first dose within 24 hours I was feeling much more sore in my left arm and I had a greater... Read more
After the first dose within 24 hours I was feeling much more sore in my left arm and I had a greater amount of fatigue that lasted for a couple of days. The second dose was worse and I was surprised the side effects continued for about seven days. Within about 48 hours of the second dose, I was feeling pain in my arm like the first time only a little worse. The fatigue was significantly more. The fever was on again off again for seven days and ranged between 99.5 and 101. I had bodyaches and chills. Though the chills didn't last very long, the body aches did (muscle and joint). Throughout that entire period, I was experiencing some pretty significant nausea. To varying degrees of intensity, the nausea was consistent for a week.
58 2021-04-09 pain in extremity Rash, chills, feeling feverish, soreness of left arm
58 2021-04-09 tremor Wheezing, vocal changes, headache, shaking
58 2021-04-10 feeling hot My husband and I drove 65 miles to get the vaccine and I was fine at the facility and left after the... Read more
My husband and I drove 65 miles to get the vaccine and I was fine at the facility and left after the mandatory 15 minutes. At around the 25 minute mark after the shot, I got dizzy, I was hot and sweaty, had anxiety and it was hard to swallow. I had my husband drive me to the hospital where we stayed in our car in the ER parking lot in case my reaction became life threatening. We stayed there about an hour and when my heart rate decreased and I could sip water again (and my anxiety subsided), then we left for home. However when we got several blocks away from the ER, my anxiety kicked back in because we had to drive over an hour on the highway to get home so back to the ER parking lot we went. After another hour, we were able to drive home.
58 2021-04-10 tingling, feeling hot, flushing When I got to the car my face felt hot and flushed, but went away. then about 45 mins later I felt d... Read more
When I got to the car my face felt hot and flushed, but went away. then about 45 mins later I felt dizzy and my feet, hands and tongue were tingling . I kept having dizzy feeling and light headed. The next day I felt nauseated and had blurry vision with not tingling in hands or feet. I felt Anxious and my heart was vibrating, I still felt light head and would have dizzy spells. On the 3rd day after the vaccination I felt like I was having a hard time breathing.
58 2021-04-11 hot flush, pain in extremity sore arm (not as sore as the first injection), fatigue, joint pain, headache and "hot flashes". I w... Read more
sore arm (not as sore as the first injection), fatigue, joint pain, headache and "hot flashes". I was able to control pain and hot flashes with Tylenol. Duration was less than 48 hours.
58 2021-04-11 numbness, pain in extremity Severe pain and numbness on my arm. Chest pain, I thought it was a heart attack.
58 2021-04-11 numbness Numbness of injection arm and hand. Nausea, dizziness, headache.
58 2021-04-11 migraine with aura, pain in extremity Received vaccine 3/16, arm and neck sore that afternoon. 3/18 developed muscle aches in back. 3/19-2... Read more
Received vaccine 3/16, arm and neck sore that afternoon. 3/18 developed muscle aches in back. 3/19-20 - experienced chills, fatigue, myalgias, headache. recovered by 3/21. 3/25-26 had another wave of dizziness, nausea, chills, HA, vomiting. 4/1 - nausea; 4/3 migraine with aura (hadn't experience migraines for several years prior). 4/5 - migraine with aura. PCP advised that she could elect to receive second dose, pt is delaying second dose for the time being.
58 2021-04-11 migraine, pain in extremity Day 1&2: Aches,slight fever, headache Day 3: breast tenderness, followed by lymph node under right ... Read more
Day 1&2: Aches,slight fever, headache Day 3: breast tenderness, followed by lymph node under right arm swelling/very painful (12 hours after tenderness began) face swelling under eyes, hand swelling and hand joint pain Days 3/4/5: joint pain spreading throughout body. Some sharp pains in various joints Day 5/6: migraine again, not as severe (responded to my medicine better) day 6 migraine better (didn't take medicine)(zololatriptan) Sharp pain in my lower right side (like the ovarian cyst pain I had when I was ovulating)
58 2021-04-11 migraine I am a chronic migraine sufferer for 40+ years. The day after my 2nd Pfizer was 16 hours of PURE MI... Read more
I am a chronic migraine sufferer for 40+ years. The day after my 2nd Pfizer was 16 hours of PURE MIGRAINE HELL. I was so nauseous from the HEAD PAIN that I could not take water or an Excedrin until 16 hours after it all began. The following days were progressively better, but my head did not feel normal until 6 days after the 2nd shot.
58 2021-04-11 pain in extremity 3:30 pm, 18 hours after second shot, very tired. I took a 200mg ibuprofin, and took a good nap as so... Read more
3:30 pm, 18 hours after second shot, very tired. I took a 200mg ibuprofin, and took a good nap as soon as I could (2 hrs after I took pill). Also sore arm for about 36 hours
58 2021-04-12 weakness 1.- Headache, Dizziness, Nauseous, High fiber, and weakness for more than 17 days. Still I do not fe... Read more
1.- Headache, Dizziness, Nauseous, High fiber, and weakness for more than 17 days. Still I do not feel 100% well. 2.-I am taking Vitamin C, Tylenol 500mg., Water, Turmeric pills.
58 2021-04-12 numbness, flushing, pain in extremity, tingling 1. severe pain left arm, hand numb and tingling. chest little tight, tongue felt funny, felt like s... Read more
1. severe pain left arm, hand numb and tingling. chest little tight, tongue felt funny, felt like something in back of throat. Had a rush of heat from chest to head like a flush feeling. Happened 10 minutes after leaving facility after my 15 wait period. Left went to vehicle sitting in vehicle going over grocery list and that is when the pain started in arm and rest followed went back in facility they made me sit in the back for while. Had real bad cotton mouth. Left after about half hour on way home had severe pain in lower back kidney area on the left. The pain subsided in kidney area to a dull ache that lasted all day on the 10th and little on the 11th. Had the cotton mouth for 3 days.
58 2021-04-12 pain in extremity, tremor Immediately following vaccine on Saturday, I experienced arm pain that increased over the day and ev... Read more
Immediately following vaccine on Saturday, I experienced arm pain that increased over the day and evening. In the evening I was somewhat more fatigued. On Monday, two days after receiving vaccine, I experienced repeated episodes of tinnitus, shakiness, and light-headiness. On Tuesday, the third day following vaccine, I again experienced repeated incidence of tinnitus. On both Monday and Tuesday, the tinnitus was worse when I was upright and better when reclining. On Tuesday I also experienced a flu-like feeling along with loose bowels, nausea, headache, and increased emotional lability.
58 2021-04-12 tingling Immediately afterwards developed tingling to the corner of her left eye. Patient states over the cou... Read more
Immediately afterwards developed tingling to the corner of her left eye. Patient states over the course of the day she developed numbness to the left corner of her lip and ear fullness. Patient states once in a while she will experience tingling to thenar eminence of her left hand. Symptoms have improved over the course of 24 hours. Patient is in stable condition and offers no additional complaints at this time. Informed patient that tingling has been a reported side effect of the vaccine, but it's unclear whether her symptoms are due to the vaccination. Patient wishes to go home. Discussed with patient diagnostic results and differential diagnosis. Patient advised to return to the ED for new or worsening symptoms. Patient is agreeable with plan for discharge.
58 2021-04-12 cold extremities No immediate adverse effects. Shot given at 10:30 am, Monday morning 04/12/21 At 3 am, 04/13/21, I... Read more
No immediate adverse effects. Shot given at 10:30 am, Monday morning 04/12/21 At 3 am, 04/13/21, I woke up with very cold feet and yet was piled with blankets in bed. I could not warm up my feet. I got out of bed to find I was, feverish, had chills, headache, and diarrhea
58 2021-04-12 tremor, pain in extremity In the early morning of 4/7/2021, after receiving the 2nd dose of Pfizer COVID 19 vaccine on 4/5/202... Read more
In the early morning of 4/7/2021, after receiving the 2nd dose of Pfizer COVID 19 vaccine on 4/5/2021, around 6:00 am, I started to experience severe chills with uncontrollable shaking. I had experienced mild chills and a sore arm starting around 8:00 pm of 4/6/2021. With the chills intensifying, I attempted to take acetaminophen to reduce fever, but began to vomit and experience uncontrolled diarrhea, both continued for several hours. My fever was over 103 and continued to be that high until approximately 8:00 pm on 4/8/2021 when it was registering between 101.8 to 102.8 through 4/9/2021. On 4/10/2021 the fever started to register between 99.9 and 101.8 and I also began to notice a blistering rash on my torso. 4/8/2021 through 4/10/2021 I was also showing signs of dehydration - dark yellow and cloudy urine. By 4/11/2021 my temperature was registering near normal, spiking to 99.9 at times. I was able to take acetaminophen and also took Benadryl for the itchy rash. It is 4/13/2021, I still have some of the rash remaining, temperature is normal and urine has become clear. I did not seek medical treatment because I never felt that my symptoms were life threatening, however the reaction was more than I had expected and am concerned that this may have been an allergic reaction.
58 2021-04-12 tremor Tachycardia for about 20 minutes, elevated BP. Resolved within half an hour. Headache, chills and pa... Read more
Tachycardia for about 20 minutes, elevated BP. Resolved within half an hour. Headache, chills and pain at injection site started around 10am. Got progressively worse during the day, and even after taking Tylenol, I couldn't stop shaking from the chills. Slept 10 hours straight. Headache, mild fever around 100 degrees, body aches and chills continued the next day. Woke up 46 hours after initial vaccine with everything resolved except for pain in injected left arm. When I tried to move it around and stretch it, I discovered that I could not lift my arm without major pain in the left shoulder. It has been nearly three weeks and I still can't lift my left arm above the level of my shoulder without pain.
58 2021-04-13 inability to speak Patient complains of subjective significant word-finding (cognitive) difficulties that developed sho... Read more
Patient complains of subjective significant word-finding (cognitive) difficulties that developed shortly after receiving her first dose of Pfizer covid vaccine (at another facility) in March, with continued symptoms after second dose of vaccine on 4/6/21. She is still having symptoms now. Patient has a neurological condition and medication that could contribute to symptoms, and we are evaluating for other possible contributors with labs (just ordered), but given the temporal relationship to vaccine administration, we have opted to report to VAERS. Patient reported symptoms, has not had in-person evaluation since symptoms developed.
58 2021-04-13 weakness The Tuesday after the vaccine I have been unable to get my blood pressure under control. I have bee... Read more
The Tuesday after the vaccine I have been unable to get my blood pressure under control. I have been dizzy, light headed and my worst blood pressure reading was 151/109. I debated to go to the emergency room because I was so weak but I waited it out. I am going to a cardiologist on Monday April 19th to try and get my blood pressure under control
58 2021-04-13 feeling cold Sore injection sight. Feverish, chills, fatigue and headache.
58 2021-04-13 flushing, weakness, cold extremities Monday at 2:00 I received my vaccine. Tuesday, The morning after I received the vaccine I had gone... Read more
Monday at 2:00 I received my vaccine. Tuesday, The morning after I received the vaccine I had gone to work. I started to feel like I was coming down with the flu. I started to feel very tired and almost weak. I stayed at work as I?m a caretaker for two young children, but I began to feel more and more achy and my joints began to hurt. I drove home at 4:30 and cranked up the heat my hands were so cold they felt like ice. I cranked up the heat. My face became extremely red and my cheeks brilliant red and flushed. I had taken a Tylenol the day of the vaccine and a Tylenol that morning and I took another Tylenol when I got home. I went straight to the couch and spent the next few hours in sweats and feeling generally lousy with aches and pains and joint pain and generally cursing those responsible for this disease process I was now experiencing. I felt much better by 10 o?clock this morning, Wednesday, but by noon was suffering from nausea. Trying to get up and do a few small things but generally having to stay quiet as I just don?t feel very good.
58 2021-04-13 muscle spasms Pt in post vaccination, spouse and pt approached nurses desk. Spouse asked what pt could take for he... Read more
Pt in post vaccination, spouse and pt approached nurses desk. Spouse asked what pt could take for her injection site pain. While standing at desk, pt complained of dizziness, nurse went around desk to assist pt. While spouse and nurse assisted pt to the floor, pt struck head on carpeted floor. Pt remained conscious, hyperventilating, complaining of left leg cramp. BP 84/68, HR108, O2 100%, Resp 28. EMS called, transported to Hospital per Spouse request.
58 2021-04-13 nerve pain, numbness and pain in extremities Developed extreme peripheral neuropathy 5 days post vaccination. It was so severe that I had to take... Read more
Developed extreme peripheral neuropathy 5 days post vaccination. It was so severe that I had to take a lot of steroids and am still on loads of gabapentin for the nerve pain. For this reason I chose not to receive vaccination #2 even though I am a teacher and at risk as I was afraid I would become disabled and unable to work.
58 2021-04-13 pain in extremity swollen lymph nodes under armpits, pain on arm
58 2021-04-13 tremor Developed shakiness after vaccine. Denies chest pain, SOB, trouble breathing or swallowing, or rash.... Read more
Developed shakiness after vaccine. Denies chest pain, SOB, trouble breathing or swallowing, or rash. SpO2 100% RA Respirations 16, unlabored. BP 172/94, 175/89 HR 86, 69
58 2021-04-14 weakness I feel well for 7-10 days and then feel ill for 1-3 days. Low-grade fever, feverish, body and muscle... Read more
I feel well for 7-10 days and then feel ill for 1-3 days. Low-grade fever, feverish, body and muscle aches, severe headache, fatigue, fainting, weak. I had my first vaccine on 1/14/2021 and my second vaccine on 2/4/2021. I felt ill after my first vaccine, however symptoms wee not severe. After my second vaccine, I became very ill. Vaccine was administered by pharmacy at my place of work.
58 2021-04-14 breast pain 5 days after first shot, Left breast swelled up, got warm and turned reddish in color. Breast got h... Read more
5 days after first shot, Left breast swelled up, got warm and turned reddish in color. Breast got hard and large lump around nipple. Called OB/GYN and was checked by them. They sent me for a mammogram on left breast and ultrasound as well. Was told that this was a common adverse reaction to covid shot. I did not know that. Would have waited to defer the cost. After second covid shot same breast was a little sore but not as bad as first shot.
58 2021-04-14 tremor, muscle spasms I had vertigo upon sitting up from bed on Saturday ( a few days after ) then quickly had pain in joi... Read more
I had vertigo upon sitting up from bed on Saturday ( a few days after ) then quickly had pain in joints, muscle spasm that bent me over. Dizzy, headache bad, fever and chills, abdominal bloating, lost appetite, tummy hurt, foggy headed, deep stretchy yawns many times the first day, then they stopped. Oh! the shaking and trembling. I waited to see if it would get worse but it didn't 4 degrees high, dropped to 2. Most of the symptoms were gone in 24 hours. The fever in two days but lower. Headache and some muscle aches remained but tylenol helped. Some vertigo remains but not barfing bad.
58 2021-04-15 inability to speak, tremor Approx. 5 minutes post second pfizer vaccine, patient began to have shaking of her bilateral upper e... Read more
Approx. 5 minutes post second pfizer vaccine, patient began to have shaking of her bilateral upper extremities, pursing lips and moaning, unable to speak, symptoms persisted, EMS was called.
58 2021-04-15 inability to speak Notable increase in subjective word-finding difficulties with temporal relation to vaccine adminstra... Read more
Notable increase in subjective word-finding difficulties with temporal relation to vaccine adminstration.
58 2021-04-15 weakness, tingling, numbness Patient reported experiencing numbness, tingling, and weakness on all limbs. This started the day af... Read more
Patient reported experiencing numbness, tingling, and weakness on all limbs. This started the day after she got the vaccine and has continued off and on until present day. She contacted her provider who does not think it is related to the vaccine but she believes it is.
58 2021-04-15 cold sweat, tremor Within 7 minutes of receiving shot, my vision was slightly impaired (darkening ) cold sweating, hea... Read more
Within 7 minutes of receiving shot, my vision was slightly impaired (darkening ) cold sweating, heart racing, head pressure and feeling I was going to faint. Emt?s and nurse assisted me. My blood pressure spiked to 176/100 and my legs and hands were shaking uncontrollably. Someone mentioned a hypertensive crisis and I was getting frightened. I requested an anti anxiety pill from my purse, which they let me have. It didn?t help me at all. I was taken to an ambulance and waited for a relative to come pick up my disabled daughter who was with me getting her covid shot as well. I asked if they were taking me to the hospital, and was told ? you don?t want to go there? after an hour, bp came down to 146/90? ..which is still too high and not typical for me.This was NOT brought on by an anxiety attack.i was not remotely anxious and was simply sitting and speaking with my daughter when I was striken. The next 3 days my heart was racing. I wear a Fitbit to bed and my heart rate recorded spikes of 116 while I was asleep. Had bouts of bad stomach pain and diarrhea the next two days. Followed up with my GP 4 days later . Still having palpitations and following up with cardiologist.
58 2021-04-15 feeling hot, pain in extremity, flushing Immediately feeling hot and flushed. Face turned red and felt hot. After about 40 minutes and using ... Read more
Immediately feeling hot and flushed. Face turned red and felt hot. After about 40 minutes and using the AC in the car, started feeling better. After getting home, approximately 1 hour after receiving the vaccine, having chills and a slight headache (not severe enough to take anything). About two hours later, arm started feeling slightly sore. At this point, chills had stopped and no more headache. The next day, no symptoms or discomfort, not even soreness in arm.
58 2021-04-15 numbness Woke in night with left arm numbness two days after second vaccine. Resolved spontaneously, but sym... Read more
Woke in night with left arm numbness two days after second vaccine. Resolved spontaneously, but symptoms returned on 3/18 and progressed to numbness over left arm, leg, trunk and face. Seen in ED and admitted for observation. Negative CT head, CTA Head and Neck, MRI brain. Started on Plavix, Atorvastatin and baby aspirin. Linq device implanted.
58 2021-04-15 migraine On 3/23/21 at 4:00 a.m. I woke up with severe heartburn, Migraine headache, body aches, chills, fati... Read more
On 3/23/21 at 4:00 a.m. I woke up with severe heartburn, Migraine headache, body aches, chills, fatigue, nausea.
58 2021-04-15 migraine I had a migraine on April 10 and 14, and I started to get one on the morning of April 16, but took m... Read more
I had a migraine on April 10 and 14, and I started to get one on the morning of April 16, but took migraine medication (Rizatriptan) and was able to head that one off. I typically get only about 1 migraine every year or two, so to get three in one week is unprecedented for me. It remains to be seen if I'll continue to have them, and I certainly won't be taking the second COVID vaccine.
58 2021-04-15 pain in extremity, burning sensation Pt with persistent LUE pain after getting her second dose of Pfizer COVID vaccine. Reports she had t... Read more
Pt with persistent LUE pain after getting her second dose of Pfizer COVID vaccine. Reports she had the 2nd dose on 3/23/21. 2 days later, she developed LUE pain. Worse in the front of her shoulder and under her armpit. Taking Ibuprofen/Tylenol with relief but if she isn't taking any, there is pain. Pain is worse with movement. Describes pain as aching/burning. Some weakness in LUE. Pt is R handed.
58 2021-04-15 pain in extremity I experienced sleeplessness for two days following the shot. As a side note, I have difficulties s... Read more
I experienced sleeplessness for two days following the shot. As a side note, I have difficulties sleeping in general. Secondly, my left arm is still sore 16 days after the shot.
58 2021-04-16 weakness, nerve pain, pain in extremity 4/15 1st night, day of shot-Severe arm pain at injection site, 4/16 Morning after shot- severe pain... Read more
4/15 1st night, day of shot-Severe arm pain at injection site, 4/16 Morning after shot- severe pain in spread from shoulder to mid and upper back. 4/16 Evening of 2nd night- nerve agitation in both arms ( feels like nerve endings were exposed) weakness in both arms and upper torso, back. 4/17 upon awakening- symptoms still same as 4/16. I feel awful!!!
58 2021-04-16 flushing, pain in extremity, feeling hot Shortly after receiving the injection, I had the sensation of the vaccine traveling through my body ... Read more
Shortly after receiving the injection, I had the sensation of the vaccine traveling through my body and it was like heat. I also began to feel a bit lightheaded. The paramedic said I was flushed. He took my blood pressure which was elevated, but my oxygen level was ok. He had me recline on a cot and monitored me for a while. I was able to drive home, but was still a bit cautious. I was very tired, had a headache and my arm was very sore for about 24 hours. For the second shot, they gave it to me reclining and monitored my BP and oxygen with no changes. For the second shot I was finishing a course of antibiotics for a sinus infection, but don't remember the medication. I didn't have a bad reaction like the first time, but could sense a little of the vaccine and a slight touch of dizziness.
58 2021-04-16 pain in extremity, muscle spasms Toes cramping severely once then progressed to extreme pain like a wave starting at toes then moving... Read more
Toes cramping severely once then progressed to extreme pain like a wave starting at toes then moving up entire body from 7 pm at night until the next day around 5 pm, this is not the worst. I did not feel well for over a month after 2nd shot. I had my annual physical feb 8 one week after shot. Those lab results reported I had stage 3a kidney failure. My GFR results were 51. as in stage 3a kidney failure! And my MCHC level was 31.7. I never had issues with either of these before. I have been retested March 8 and am back to normal results.
58 2021-04-17 discomfort rash on her upper left thigh; doctor said her rash looked like Shingles; rash was itchy in the begin... Read more
rash on her upper left thigh; doctor said her rash looked like Shingles; rash was itchy in the beginning with little blisters; rash was itchy in the beginning with little blisters; rash was just a bothersome discomfort; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot Number: EN6206; Expiration Date: 30Mar2021) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient took her first COVID-19 Vaccine dose on 11Mar2021. She said she had noticed on 13Mar2021 a rash on her upper left thigh that she had never seen before. She said she called her sister, who is a retired nurse, and her sister told her to call her doctor. She said she had a virtual visit with her doctor on Monday, and her doctor suggested she call Pfizer for further information about the COVID-19 Vaccine. She said her doctor said her rash looked like Shingles. The caller said her rash wasn't very painful. She said her rash was more bothersome than anything. She said her rash was itchy in the beginning with little blisters. She said after 5-6 days, the blisters flattened out. She said she still had marks on her legs from where the blisters were. She said her rash was not serious, and she did not have pain. She said the rash was just a bothersome discomfort. She said the rash cleared up quickly without her taking any antiviral medication. She said her doctor said her rash looked like a very mild case of Shingles. She said her doctor told her she didn't need to take anything, like an antiviral medication, for her rash, if she didn't want to. She said she chose not to take anything, and her rash cleared up on its own. She said she was scheduled for her second COVID-19 Vaccine dose on 01Apr2021, and she wanted to verify with Pfizer if she should get the second COVID-19 Vaccine based on her reaction to her first COVID-19 Vaccine dose. Caller was advised she would be transferred to Pfizer Medical Information for further assistance with her question. Caller stated compared to the alternative, getting the COVID-19 Virus, her rash was nothing. She said her sister was more concerned about her rash than her. She said her doctor said for her to follow-up with Pfizer to confirm it was OK for her to get the second COVID-19 Vaccine. Caller wanted to know if she should get the second COVID-19 Vaccine after having a Shingles rash after the first COVID-19 Vaccine. Outcome of the events was recovered. Information on the lot/batch number has been Provided No follow-up attempts are needed. No further information is expected.
58 2021-04-17 facial paralysis facial drooping; chills; nauseated; tired; stomach cramping; a little wheezy; This is a spontaneous ... Read more
facial drooping; chills; nauseated; tired; stomach cramping; a little wheezy; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), dose 1st via an unspecified route of administration, administered in Left arm on 23Mar2021 14:00 as single dose for covid-19 immunisation. Medical history included Immunocompromised. Concomitant medications included levothyroxine sodium (SYNTHROID), amlodipine, eszopiclone (LUNESTA), rabeprazole. The patient previously took hydrocodone, oxycodone, augmentin and experienced Known allergies. On 24Mar2021 13:00, patient experienced facial drooping, chills, nauseated, stomach cramping, tired, a little wheezy. There was no treatment received for the adverse events. The patient had no COVID prior vaccination and nasal swab was tested post vaccination. The outcome of the event was recovering.
58 2021-04-17 muscle spasms After first dose she was nauseous later that day and the next day, she got severe cramping in the th... Read more
After first dose she was nauseous later that day and the next day, she got severe cramping in the thigh area of right leg; After first dose she was nauseous later that day and the next day, she got severe cramping in the thigh area of right leg; This is a spontaneous report from a contactable consumer or other non-health care professional. A 58-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in left arm on 06Mar2021 at 01:15pm (age at vaccination 58-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in left arm on 28Mar2021 both as a single dose for COVID-19 immunization. Medical history included allergies to Demerol, surgical tape and cortisone. The patient's concomitant medications were not reported. On 6Mar2021 at 1:00pm, patient mentioned that after first dose she was nauseous later that day and the next day, she got severe cramping in the thigh area of right leg. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Mar2021. Patient did not receive the treatment for events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
58 2021-04-18 weakness Temperature up to 102, sensitive skin, achy joints, achy muscles, lack of energy/tired
58 2021-04-18 involuntary muscle movements 58 y/o W female with onset of LOC with involuntary UE/LE movements approximately 3-5 minutes after r... Read more
58 y/o W female with onset of LOC with involuntary UE/LE movements approximately 3-5 minutes after receiving vaccination. Member was transferred to wheelchair and after brief period of time regained responsiveness. Member reported nausea, unable to recall recent events and denied any medical hx to include current medication. Member with multiple episodes of vomiting. Member's care was transferred to EMS and transferred to University of Hospital for elevation of care.
58 2021-04-18 hot flush, tingling, numbness, feeling cold At 11:06AM shortly after vaccine was administered, patient experienced numbness and tingly arms. She... Read more
At 11:06AM shortly after vaccine was administered, patient experienced numbness and tingly arms. She was lightheaded and vitals were BP 138/88 mmHg, HR 58 beats per minute, PO2 98%, and temp 97.6 degrees Fahrenheit. At 11:15AM vitals: BP 168/110 mmHg, PO2 98%. Patient is dizzy, legs tingly/heavy, and experiencing hot and cold flashes. At 11:30AM upper lip tingly, patient denies difficulty breathing or swallowing. 12.5 mg Benadryl given at 11:30AM and second dose of Benadryl 12.5 mg given at 11:40AM. At 11:45AM EMS called. Vitals: BP 151/85 mmHg, HR 83 beats per minute. Patient states tongue is tingly and experiencing full body chills. Upon EMS arrival, patient transported to Hospital.
58 2021-04-18 nerve pain, tingling, numbness Tingling and numbness in three left toes of left foot; tingling in pinkie/ring fingers of left hand;... Read more
Tingling and numbness in three left toes of left foot; tingling in pinkie/ring fingers of left hand; random "pings" (nerve-related) around body; mild tingling/numbness in lips. These symptoms concern me because I was hospitalized for Guillain-Barre Syndrome in July, 2020 and numbness/tingling in the feet was one of the initial symptoms of GBS. GBS is an auto-immune condition which can cause temporary paralysis and, depending upon its severity, death. It is is usually self-limiting but can take months or years to resolve. In early stages it can be treated with IV immunoglobulin to replace "bad" antibodies with "good" ones and that is the five day treatment I had at Hospital over the summer. I am very nervous that the Pfizer vaccine may be triggering another GBS episode though everything I have read says that there have been reported instances of this happening. Still, I thought it concerning enough to contact my primary care physician and website because GBS is no joke.
58 2021-04-18 sensory loss, numbness Veins pain, leg numbness, loss of sensation in the legs, urinary
58 2021-04-18 tenderness, numbness, tingling Sever tingling and numbness all over my body, face, arms, fingers, legs, feet etc, Chills, Tiredness... Read more
Sever tingling and numbness all over my body, face, arms, fingers, legs, feet etc, Chills, Tiredness, headache, muscle pain, nausea, tenderness in the arm, swelling, Swelling hands and feet, dizzy
58 2021-04-18 tremor Patient reported having symptoms of low blood sugar after both Pfizer covid shots. Reported shakines... Read more
Patient reported having symptoms of low blood sugar after both Pfizer covid shots. Reported shakiness. When blood glucose was tested had a number in the 80s and 90s.
58 2021-04-19 discomfort, throat numbness, tingling, numbness TINGLING, NUMBNESS IN FACE AND THROAT. TINGLING AND HEAVINESS IN ARMS AND LEGS. FAST HEARTBEAT. TOOK... Read more
TINGLING, NUMBNESS IN FACE AND THROAT. TINGLING AND HEAVINESS IN ARMS AND LEGS. FAST HEARTBEAT. TOOK STEROID WHEN I GOT HOME. ALL STARTED AFTER 35 MINUTES AFTER INJECTION. NOTIFIED PHARMACIST THEY HAD ME SIT FOR ADDITIONAL TIME.
58 2021-04-19 feeling cold, weakness 4/11/21 6:30 p.m. - Started feeling very tired, weak. 4/12/21 1:30 a.m. - extreme chills, couldn?... Read more
4/11/21 6:30 p.m. - Started feeling very tired, weak. 4/12/21 1:30 a.m. - extreme chills, couldn?t get warm. 4:30 a.m.. - woke up, felt that my body was on fire. Struggled to get to the bathroom, could hear my heart pounding in my ears, had a terrible headache. I wasn?t able to move for about 45 minutes, I felt so sick and weak. Finally managed to get a thermometer, my temp was 102(my normal temp is 96). Finally got back to sleep only to wake up every hour (for about 8 hours) with intense need to urinate excessively each time. I was unable to get out of bed for 3 days, headache the entire time. I am still tired and weak .
58 2021-04-19 feeling cold, feeling hot Patient presents to med obs 1 via wheelchair and staff member. The patient requires a medical transl... Read more
Patient presents to med obs 1 via wheelchair and staff member. The patient requires a medical translator. The patient states her body feels cold and her face feels warm, patient reports it feels "like a hot flash". The patient reports feeling "itchy" in her thighs, arms and "all over". The patient is placed in a semi fowlers position and vitals obtained. After 15 minutes the patient reports she "feels fine" and requests to leave. Patient will be driving herself home and states she feels comfortable doing so. The patient is escorted out by staff without incident. HR- 64 Resp- 20 BP-133/74 SpO2-99% 1504 - Sitting HR- 62 Resp- 20 BP-110/73 SpO2- 100%
58 2021-04-19 feeling cold The day after the shot (Saturday), I started getting the chills and I was fatigued. My temp topped ... Read more
The day after the shot (Saturday), I started getting the chills and I was fatigued. My temp topped at 102.5. My arm at the injection site was very sore, hot and hard and had a rash about 3" in diameter. My fever came and went all day and into Sunday morning, then it seems to subside, though I was still tired. Monday, I thought I was fine and resumed my normal activity of gardening. At about 4pm, I got the chills again and had a low grade fever, 98.5. (I usually run about 96.9). Besides this, my arm was hot and the rash went down my arm. It was about 6" long and 4" wide. I marked the borders to make sure it didn't spread any more. This morning, Tuesday, The rash is still within the border and not as red, but still hot and itchy. I am also fatigued today.
58 2021-04-19 feeling cold Body chills and headaches, tiredness,
58 2021-04-19 feeling jittery, cold sweat, flushing I felt an intense sensation of heat throughout my body, a strange sensation in my mouth and an odd t... Read more
I felt an intense sensation of heat throughout my body, a strange sensation in my mouth and an odd taste. A lump formed in my throat with phlegm that caused me to need to cough to clear my throat. I felt very jittery. Staff at the clinic reported I felt clammy to touch and that I became pale. I was given oral Benadryl and staff reset the clock. I experienced several of these intense body-wide heat waves while at the clinic. Staff told me I was not having an allergic reaction but that my "body was reacting to a foreign substance introduced into my body." I was told to return for the 2nd shot on 5/5/21 and staff will premedicate me with Benadryl.
58 2021-04-19 numbness, weakness, tingling back pain, weakness, chills, fevers, numbness and tingling of arms
58 2021-04-19 migraine Chills, nausea & vomiting, fatigue, joint pain, migraine
58 2021-04-20 weakness 16 hrs post second vaccine, flu like symptoms, fever 101, muscular aching, weakness, loss of appeti... Read more
16 hrs post second vaccine, flu like symptoms, fever 101, muscular aching, weakness, loss of appetite. Lasting approximately 32 hours. Tylenol 2x 500mg every 6 hours.
58 2021-04-20 burning sensation Vaccinated 3/23 at 1:30 p.m. 5 hr post: fatigue body aches mild. 9 hrs post Temp 101.7 increased jo... Read more
Vaccinated 3/23 at 1:30 p.m. 5 hr post: fatigue body aches mild. 9 hrs post Temp 101.7 increased joint pain, severe body aches nausea. Tylenol taken. Fever broke 18 hrs post. Felt better. on 3/24 at 12 noon 22 hrs post vaccination: HA, increased joint pain, body aches, fatigue. Temp 101.7. Tylenol taken. At 4 p.m. Temp 100.1. Symptoms continued. At 8 p.m. 30 hrs post vaccine Temp: 102.7 Increased symptoms of joint pain, HA, fatigue, nausea. 3/25/21 Approximately 34 hrs post vaccine at 0015 a.m. Temp 103.4. Severe joint pain, full systemic body aches, fatigue, HA, nausea. Tylenol taken w/continued increase fluids as tolerated. Approximately 40 hrs post vaccine at 0600 significant diaphoresis, fever broke down to 100.2. Slept 4 hrs. Awoke to temp 99.8 approximately 44 hrs post vaccine. Employee health notified. Wanted VAERS report filed and also COVID 19 test done this day. (COVID Neg 3/25) On 3/26: Severe lower back pain occurred. One area only and non-radiating. Pain Sharp and burning. This was not typical chronic pain and it occurred without any trauma or significant event. This back pain lasted from 3/26 through a.m of 3/30. ( It was not relieved by any oral pain medication. It made any ADLs difficult. Unable to sleep due to pain. It remained severe and constant until 3/30 in which it went away Phone call to primary physician. Back xrays were ordered and negative. Lab tests normal.
58 2021-04-20 numbness 4/21/2021 was observed post Covid-19 immunization for 15 minutes . During the observation period, s... Read more
4/21/2021 was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: numbing of lips and tongue and left arm. Assessment : Time of assessment 1314. Alert and oriented and numbing to left arm, lips, and tongue. Actions taken: Vitals sign taken EMS called at 1334. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 1338. VS at 1334- BP- 133/88, P- 88, O2- 97%, recheck at 1345- BP- 120/82, P- 74, O2- 98% Medications administered: Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 1314 and 1319. Administered by RN. Disposition:Patient evaluated and transferred to the hospital for further evaluation and care. Time of transport: 1338. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 12:42 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc
58 2021-04-20 numbness Numbness to face, 166/90, HR 83, O2Sat 90. Pt. stated that she was feeling better. Recommended to c... Read more
Numbness to face, 166/90, HR 83, O2Sat 90. Pt. stated that she was feeling better. Recommended to contact 911 or Primary Care Doctor if still having symptoms, Understanding verbalized.
58 2021-04-20 migraine Severe migranous headache starting 4/15 and fever starting 4/19.
58 2021-04-20 pain in extremity, cold sweat, numbness, tingling I got a Mighty sore arm about 4 hours after injection. 30 hours later I began to feel agitated and g... Read more
I got a Mighty sore arm about 4 hours after injection. 30 hours later I began to feel agitated and grouchy. I woke up about 44 hours after vaccine with a painful and swollen left thumb joint. I felt strangely tired. While walking a couple of hours later I felt drunk and dislocated from my body. 48 hours after receiving the vaccine, I felt a shocking jolt to my entire body. Immediately my left arm began a deep painful tingling from my shoulder to my fingertips, then began to feel numb and tingling and as if it were swelling. I lost my vision, felt like I was going to pass out, turned extremely pale, broke out in a cold sweat, then my shins and feet began to tingle. I felt as though I couldn?t breathe. My vision came back but my body felt dislocated and my head a cinder block. It took great concentration to move my limbs and speak. I couldn?t find the words I wanted. This lasted for about 15 minutes just like a complete shock to my nervous system. I was very irritable and exhausted for 4 days following.
58 2021-04-20 pain in extremity 8 hours post vaccine , Headache, vomiting, full arm pain, agitation, lasting approximate 3 hrs. I... Read more
8 hours post vaccine , Headache, vomiting, full arm pain, agitation, lasting approximate 3 hrs. Ice on arm and Advil 2x 500mg
58 2021-04-21 cold sweat awakened from sound sleep with intense sharp pain in upper torso that radiated to my back as well. P... Read more
awakened from sound sleep with intense sharp pain in upper torso that radiated to my back as well. Pain was so intense that my BP was 166/94. Nauseous, lightheaded, couldn't even sit up. Crumbled to a ball on the floor. Cold sweats. Lasted almost over 30 minutes. Within an hour BP was back to normal 122/70.
58 2021-04-21 feeling cold Woke up with bad headache next day went to work and left at 12 felt so bad. No fever, just severe h... Read more
Woke up with bad headache next day went to work and left at 12 felt so bad. No fever, just severe headache, full like symptoms, freezing, body aches, ear ache, jaw ache, teeth hurt, also my eyes were weird like not clear in seeing. I also have woken up with my body completely wet but not sweating g or cold. So weird. This has happened each night after second shot. I had lower back pain and that started after first shot but I didn?t realize that it was from the 1sr shot done on 03/30/2021.
58 2021-04-21 migraine, pain in extremity, tremor Initially after shot, had headache and sore arm. @ 10:00 pm began with chills, escalated to very hig... Read more
Initially after shot, had headache and sore arm. @ 10:00 pm began with chills, escalated to very high fever, shaking, severe joint pain, massive migraine headache, cough, aches and pains all over body. Could not get out of bed. Intense reaction lasted until Tuesday around 8:00 am. Then fever came and went for rest of day, migraine, cough, runny nose, burning sinuses, exhaustion and aches and pains continued through day. By 9:00 pm Tuesday evening, migraine moved to bad headache, aches and pains/joint pain subsided, cough and sinus issue remained along with exhaustion. Wednesday 6:00 am regular headache, minor cough, minor cold like symptoms with some runny nose and sinus burn.
58 2021-04-21 pain in extremity This was my second dose which had scheduled 4 weeks apart even though it was supposed to be 3. Abou... Read more
This was my second dose which had scheduled 4 weeks apart even though it was supposed to be 3. About 36 hours after this second shot I began having incredible pain in my feet. (I do periodically have problems with my feet, but this episode which is still ongoing is like something I had over 10 years ago. I couldn?t walk for a few days. While my right foot is doing much better the pain in my left foot is debilitating. As I am hobbling, I?ve now aggravated my left knee and hip. I scheduled chiropractor for April 26.
58 2021-04-21 pain in extremity Right lower extremity pain for the past 3 weeks after having Johnson Johnson vaccination on 4/5/2021
58 2021-04-21 pain in extremity Symptoms began as LUE pain in the early morning the day after vaccine. Body pain and muscle aches be... Read more
Symptoms began as LUE pain in the early morning the day after vaccine. Body pain and muscle aches began by 10 am. Chills and fever came next, at around noon. Sudden onset of Shortness of Breath came on around 1:30 pm, with O2 sat dropping to 79-80% at home. Went to ER by 2:00 pm. Fever spiked to over 102. O2 sat fluctuated between 80s and low 90s %. Admitted with new onset of mild CHF and SOB. Remained in hospital for 2 days/nights until O2 stayed in the 90s. Fever and other symptoms remained, and I have continued taking Tylenol every 4-6hours.
58 2021-04-21 tenderness Chills, fever, vomiting, diarrhea, muscle aches, fatigue, and an angry red rash that started on my l... Read more
Chills, fever, vomiting, diarrhea, muscle aches, fatigue, and an angry red rash that started on my left foot and gradually moved up underneath my knee. It was red, hot to the touch, swollen, and painful.
58 2021-04-22 bell's palsy Patient diagnosed with Bell's Palsy on 4/20/21, 10 days post-vaccine
58 2021-04-22 burning sensation, pain in extremity, tingling Immediate chest tightness. 10 minutes in severe burning at on upper arm and pain. At same time entir... Read more
Immediate chest tightness. 10 minutes in severe burning at on upper arm and pain. At same time entire stomach area, abdomen began with intense itching. No hives, swelling or redness. Tachycardia present 139. sPO2 97, respiration?s 22. Stayed in observation for 30 minutes, when outside and in car left eyelid itching and now swollen. When home Dyspnea began and itching and prickling sensation began systemically all over body. Took 25 mg. Diphenhydramine and 20 mg. Famotidine. 20 minutes later worse and now upper lip swollen and numb, facial puffiness, nose extremely swollen and red, neck swollen and upper chest red. Got Epi Pen and drove 25 minutes to ED. No issues with breathing, or swelling of throat, tongue or uvula. BP 151/91, HR 112, respiration?s 18 at triage taken into ED and given 60 mg. po of Prednisone observed 4 hours. At 2 hours symptoms began to return to baseline, tachycardia resolved now 87. Discharged with 50 mg. Prednisone daily for 4 days, Diphenhydramine 50 mg. q6h for 13 doses and Famotidine 20 mg. bid x3 days. Referred to immunologist.,
58 2021-04-22 difficulty speaking, tremor 20 minutes after the shot, my jaw and tongue felt tingly, my voice felt hoarse, An hour after shot I... Read more
20 minutes after the shot, my jaw and tongue felt tingly, my voice felt hoarse, An hour after shot I had the shakes. Within 2 hours all these symptoms were gone. Arm continued to be sore at injection site for two days.
58 2021-04-22 pain in extremity Initially had two days of normal soreness which resolves then on 7 April 2021 she noted the sorenes... Read more
Initially had two days of normal soreness which resolves then on 7 April 2021 she noted the soreness returned to the arm causing her decreased ROM secondary to the pain Caller states she called her doctor who advised to move the arm more to out work out the soreness which she really hasn't been doing 4/13-f/u call made; minimal changes in symptoms; continues to increase ROM and using heating pad PRN
58 2021-04-22 pain in extremity 4/20/21 sore upper left arm and chills - all day 4/21/21 sore upper left arm, chills, vomiting begin... Read more
4/20/21 sore upper left arm and chills - all day 4/21/21 sore upper left arm, chills, vomiting beginning at 1 a.m. and continuing until 11:15 a.m. began taking Ondansetron 4mg, diarrhea began at 7:15 a.m. and continued all day 4/22/21 some chills, diarrhea continued until 1:45 a.m. 4/23/21
58 2021-04-23 weakness severe ringing in ears, sever fatigue still 8 days later, body aches, head ache, stomach upset, seve... Read more
severe ringing in ears, sever fatigue still 8 days later, body aches, head ache, stomach upset, severe brain fog, weakness - all running for 8 days since I was vaccinated! What is the point of getting sick for 8 days and running?? Its like having covid again!!
58 2021-04-23 electric shock sensation A few minutes after injection felt a quick electric-like shock across top of head and momentary fain... Read more
A few minutes after injection felt a quick electric-like shock across top of head and momentary faintness. A few minutes more, I began to have a tight feeling in my throat and swallowing was difficult. Felt the need to swallow frequently. Got nervous so stayed past 15 minutes. At 30 minutes, it wasn't getting worse and my breathing felt fine so I left (foolishly) the vaccination site. Throat felt tight the rest of day. Kept feeling the the need to clear my throat. Sore. Hard to swallow. At 10:15pm, the tightness and swallowing issue abruptly stopped. Throat felt sore for next 2 weeks. Asked pulmonologist if my allergy and asthma medication could have suppressed a more insidious reaction. Did not know. Saw allergist. She did not know either but gave me an epi-pen if I was going to try shot 2. Also suggested J&J as an alternative. Ordered blood tests for reactivity to 2 chemicals close to PEG. (no blood test for it). Results not back. Noted that I was taking lisinopril which is an ACE inhibitor. Said they can cause swallowing problems. Cardiologist did not think so but changed my medication to a calcium channel blocker instead. Called Pfizer. They classified my reaction as an immediate adverse event and took a record of it. I canceled my second Pfizer shot appointment because the CDC site says not to take second shot if you have an immediate adverse reaction. Very disappointed and confused how to proceed. Mixed advice from doctors. Really wanted to be vaccinated. Really don't want to have a worse anaphylactic reaction which my pharmacist could happen if i tried it again. Don't feel safe trying it at the mass vaccination site at the beach.
58 2021-04-23 pain in extremity I delivered one baby in 1999 and one in 2002. Two miscarriages in between. I woke up 4/6/21 with a... Read more
I delivered one baby in 1999 and one in 2002. Two miscarriages in between. I woke up 4/6/21 with a strange pain in my left leg. It felt circulatory, not muscular or skeletal. Swelling behind knee. I went to ER for ultrasound and they found a blood clot. Cat scan revealed pulmonary embolism. The nurses at the hospital confirmed that this was happening frequently. They said it wasn?t rare. My PA at the clinic told me it was 1 in 5000 like me. Why doesn?t the hospital report? I?m on bed rest for 10 days, compression stockings and Eliquis to thin my blood. I have halted all HRT, but have been told by my dr that it?s clearly not related since i e been on them for over 6 years and never had a blood clots.
58 2021-04-23 tingling, weakness, pain in extremity headache chills weakness dizziness nausea no appetite body aches tingling in feet and hands pain in ... Read more
headache chills weakness dizziness nausea no appetite body aches tingling in feet and hands pain in the arm that received shot sleepiness I kept hydrated took arnica and CBD cream on my arm took a 2 hr nap which I never do felt better 14 hrs later with only headache and mild symptoms
58 2021-04-24 discomfort pain by my ear on my face/ lymph node; throbbing pain; swelling; experiencing discomfort; This is a... Read more
pain by my ear on my face/ lymph node; throbbing pain; swelling; experiencing discomfort; This is a spontaneous report from a contactable consumer (patient reported herself). A 58-Year-old non-pregnant female patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her right arm on 19Feb2021 02:30 PM (Lot number: EN 6201) as single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications were reported as none. She was allergic to celecoxib (CELEBREX) (Known allergies: Celebrex). Other medical history was none. Facility type vaccine: Other. The patient previously took first dose of BNT162B2 (COVID 19, Pfizer) to her right arm on 29Jan2021 02:30 PM as single dose for Covid-19 immunization. Other medications in two weeks was reported none. It was reported that, on 19Feb2021 05:00 PM, three hours after receiving the second vaccine experienced pain by ear on face. With a little research she found out there was a lymph node called preauricular. She had throbbing pain and swelling. It was been three days since Covid shot and still experiencing discomfort. No Covid tested prior/post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
58 2021-04-24 difficulty speaking, numbness Hard to swallow; Voice went hoarse; Scalp itched/ Insider ear canals itched; face went numb; This is... Read more
Hard to swallow; Voice went hoarse; Scalp itched/ Insider ear canals itched; face went numb; This is a follow-up spontaneous report received from a contactable consumer (patient). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscularly, administered in left arm on 24Feb2021(at the age of 58 years old) at 16:15 (Batch/Lot Number: EM9809) as a single dose for COVID-19 immunization. Medical history included ongoing asthma (10 years) and ongoing fibromyalgia (40 years). Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient previously received dose 1 of BNT162B2 intramuscularly in the left arm on 03Feb2024 at 16:00 (Batch/Lot number: EL9262) and 1 hr. after dose, tongue, lips and cheeks went numb. Last 30 min went away (recovered same day). On 24Feb2021, 5min after 2nd dose, her face went numb, it was hard to swallow, her voice went hoarse, her scalp itched, and inside inside ear canals itched. She called over paramedics who monitored me for an hour. The events did not get worse and she went home. After 2 and half hours passed since getting the vaccine, all events resolved (on 24Feb2021) except itch (not recovered). She took Benedryl and woke up fine. The patient assessed the Pfizer product had a causal attribution to the events. The reporter assessed the events as medically important. No follow-up attempts are possible. No further information is expected.
58 2021-04-24 feeling hot, burning sensation, numbness numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side; ... Read more
numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side; tongue has been numb; really feel weird on her face; burning sensation that shot across the top of her left ear and nose/burning sensation down the left side of her body; left side of her face started to feel hot; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left, at the age of 58-year-old, on 31Mar2021 18:45 as SINGLE DOSE for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 31Mar2021, a half an hour later, as the patient was driving home, the left side of her face started to feel hot and she kept putting her right hand on it to cool it off. The patient got a burning sensation that shot across the top of her left ear and nose. Once at home, she started to really feel weird on her face, and she had a burning sensation down the left side of her body. Her face felt strange for 1 hour and then declined. The patient went to bed at 09:30P.M. and she noticed numbness in her left leg. The next morning, the numbness in her left leg was much worse and she had numbness in her left arm down to fingers. States she called the doctor when they opened at 09:00 A.M. and they said to go to the ER right away because of all the numbness. The ER treated her like a stroke patient, and wanted to make sure she didn't have a stroke so she had a full MRI, Cat Scan, and Bloodwork done that all came back normal. The patient was in the ER on 01Apr2021 morning and she was admitted for observation and she came out of the hospital 02Apr2021 before 5:00P.M. The doctor ordered more bloodwork and a CT with contrast was ordered for her spine to see if she has any spinal damage. The patient saw a neurologist on 05Apr2021, she has had more numbness on the right side. Clarified that her right foot feels numb intermittently along with the right side of her face. Her tongue has been numb on 31Mar2021, like a line across it, most of the time. The numbness ebbs and flows and where she feels it, moves around. It is not as strong as a week ago but it moves around. No treatment was given in response to the events. She stated the neurologist and no one has recommendations on if she should receive the second dose. Outcome of left side of her face started to feel hot, really feel weird on her face was recovering; tongue has been numb was not recovered;Burning sensation recovered on 31Mar2021, numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side was unknown. Follow-up attempts are completed. No further information is expected.
58 2021-04-24 hot flush, feeling cold She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my... Read more
She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my tongue and cheeks; cold rush throughout my body; hot flash; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 09:45 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunisation. Medical history included acid reflux, pre type II diabetes, Hashimoto's disease and possible Sjogrens; she was allergic to shellfish and berries. The patient had unspecified concomitant medications. The patient previously took and had allergies to sulfur, epinephrine and lidocaine. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number EN6207) (at 58 years of age), dose 1 in the left arm on 16Mar2021 for COVID-19 immunisation. The patient was not pregnant. The patient had no covid prior vaccination. She has not been tested post vaccination. It was reported that on 06Apr2021 10 AM, after just 13 minutes (as reported) of the shot, the patient experienced swelling of her tongue and cheeks along with a cold rush throughout her body followed by a hot flash. She felt unstable and felt like she might pass out. The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events- treatment included BENADRYL day 1 and Prednisone added day 2. The patient was recovering from the events.
58 2021-04-24 numbness numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; numbing on th... Read more
numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (lot number: ER8727), via unspecified route of administration in left arm on 26Mar2021 11:45 AM at single dose for COVID-19 immunisation. The patient's medical history included primary central nervous system lymphoma and seizure. The patient had allergies to tree nuts. The patient's concomitant medications included vitamins, fish oil. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received levetiracetam (KEPPRA) (anti-seizure medication) that she had stopped in end of Jan2021. Approximately 21 hours after injection of vaccine, the patient experienced numbing on the left side of face - eye, cheek, mouth - and left fingers, thumb to pinky. Lasted about 10 minutes and feeling came back. Same thing happened 15 minutes later and then stopped. Events onset date reported as 27Mar2021 09:15 AM. The event resulted in doctor or other healthcare professional office/clinic visit. The patient contacted her oncologist, she resumed taking levetiracetam and will continue until 2 weeks after next shot (if decide to get it). The patient had routine brain MRI and all clear. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
58 2021-04-24 nerve pain This is a spontaneous report from a contactable female consumer(patient). A 58-year-old female patie... Read more
This is a spontaneous report from a contactable female consumer(patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in right upper arm on 31Mar2021 19:00 (Batch/Lot number ER8730) as single dose for COVID-19 immunization. Medical history included ongoing trigeminal neuralgia, ongoing urinary tract infection, COVID early January (her pulse ox was like 90. States that her second time back she had an inhaler and had a fever for 13 days, she never wants this again), shingles. Concomitant medication included pregabalin (LYRICA) taken for trigeminal neuralgia, started in around 2012; oxcarbazepine (TRILEPTAL) taken for trigeminal neuralgia, started in around 2012; methenamine Hippurate taken for urinary tract health, had been taking from 6 months to a year; trimethoprim taken for urinary tract health; diclofenac taken for arthritis, start and stop date were not reported. No prior vaccination within 4 weeks. No family history. The patient had light sensitivity on the right side, of her forehead, not in the left. She did not know if this was an adverse effect but started to notice symptoms on 03Apr2021. On 03Apr2021 she questioned if she banged her head. The patient was not thinking that it was shingles. Sunday on 04Apr2021 it was a little more evident. It felt like facial neuropathy pain, almost like shingle, it felt like tingling pain shingle. The patient went to work on 05Apr2021, and the top of her scalp was hypersensitive to touch near her temple and her whole eyebrow. She was so concerned because it was so close to her eye and eye lid. It was little but also feels on the right side of her nose. It was very sensitive, like hypertensive to the touch. Stated that it felt almost like a sinus headache, like pressure. Last evening on 05Apr2021 it had gotten worse and felt like shingles. The patient took a 25mg capsule of Benadryl 05Apr2021 because she didn't know if she was having a reaction. The patient stated that it was neuropathy pain. Even the slightest touch of her bangs was very sensitive, and in the eye are, including her eyebrow and forehead near the scalp. She had trigeminal neuralgia but had never had on the right side. Knew what neuropathy felt like. She had red blotches on her forehead and into her scalp. She first noticed it on 05Apr2021 and had gotten a little worse. It was where her eyebrow ends and near the temple and into her hairline. It was moderate. The patient also had moderate symptoms from the shot. She had a slight fever, nothing over 100, that it was 99.6. She had chills, aches, and nausea. Stated that she had regular symptoms of COVID that lasted 2 days and then they were done. The patient just Motrin for treatment on 05Apr2021. The patient was surprised where they gave her the shot. She had a little mark that looked normal but stated that it felt a little scaly but just a little. There was a small ring where you could see where it was given. She had no tests. She had only had the positive COVID test in January, she had not had anything done since. Her next dose was supposed to be 21Apr2021. The outcome of event sensitivity in right side of forehead was not recovered, outcome of events slight fever, chills, aches, and nausea was recovered, outcome of events was unknown.
58 2021-04-24 pain in extremity Fever; Cough; Backache; Headache; Nausea; dizziness; pain in the right hand; Tiredness; This is a sp... Read more
Fever; Cough; Backache; Headache; Nausea; dizziness; pain in the right hand; Tiredness; This is a spontaneous report from a Contactable Consumer (patient). A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 58 years of age, via an unspecified route of administration on 24Feb2021 16:30 at single dose, in right arm for COVID-19 immunisation. The patient medical history included type 2 diabetes, high blood pressure, factor 5 leiden. Patient was had allergic reaction with cephalexin, tramadol, ibuprofin, peanuts. Concomitant medication included Bactrim (SULFAMETHOXAZOLE, TRIMETHOPRIM). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 58 years of age, via an unspecified route of administration on 03Feb2021 16:15 at single dose, in right arm for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 24Feb2021 19:00, the patient experienced fever, cough, backache, headache, nausea, dizziness, pain in the right hand and tiredness. The events were considered as non-serious. No treatment was given for the events. The outcome of all the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
58 2021-04-24 pain in extremity Tightness in chest; shortness of breath; headache; sore arm; This is a spontaneous report from a con... Read more
Tightness in chest; shortness of breath; headache; sore arm; This is a spontaneous report from a contactable consumer. This consumer(patient) reported for herself that a 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at the age of 58-years, via an unspecified route of administration in left arm on 03Apr2021 09:15 AM at single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy, asthma, hypothyroidism. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol; bupropion hydrochloride (WELLBUTRIN); desvenlafaxine succinate (PRISTIQ); loratadine and synth (as reported). The patient historically received first single dose of BNT162B2 (lot number: EN6199) via an unspecified route of administration in left arm on 06Mar2021 09:30 AM for COVID-19 immunization. The patient previously took Compazine and experienced allergy to it. On 03Apr2021 22:00 (10:00 PM), the patient experienced tightness in chest, shortness of breath, headache, sore arm. The events resulted in emergency room/department or urgent care. Patient received nebulizer treatment for the adverse events. Outcome of the events were not recovered. Since the vaccination, the patient been has not tested for COVID-19. No follow-up attempts are needed. No further information is expected.
58 2021-04-24 pain in extremity Increase in hand and fingers joint pain, swelling, and decrease in strength and range of motion; foo... Read more
Increase in hand and fingers joint pain, swelling, and decrease in strength and range of motion; foot and ankle pain ; will be seeing doctor due to increase pain and loss of strength
58 2021-04-24 pain in extremity 8 hours after receiving injection, started having a sore throat. 48 hours after injection noticed a... Read more
8 hours after receiving injection, started having a sore throat. 48 hours after injection noticed a small grape size lump/knot close to collar bone (lymph node?) on left side which is the injection side. 72 hours after injection, I had lost my voice, not totally. Sounds like I'm whispering when I talk. I also had the normal reported sore arm, but was quite bothersome for 3+ days. I have also noticed some shortness of breath and still quite tired after doing several small chores. I am currently on day 11 after injection, and have another smaller lump/knot beside the first one that appeared by my left collar bone. The only side effect that has dissipated is the sore arm, I still am having fatigue, shortness of breath, lumps near collarbone and loss of voice. I have not seeked medical treatment since I have no health insurance. I felt like these would subside, but have not so far. I am really hesitant to receive my 2nd dose since claims are that it is worse that the first, regarding side effects. I feel that my body has not recuperated from trying to build up my immunity. As stated above, my side effects have not subsided as of today's date, 11 days after receiving the 1st dose injection.
58 2021-04-25 weakness 101.3 temp developed 12 hrs after 2nd Vaccine. Fatigue and weakness lasted until I woke up on 1/26/2... Read more
101.3 temp developed 12 hrs after 2nd Vaccine. Fatigue and weakness lasted until I woke up on 1/26/2021 at 0500. Felt much better & no fever only problem was bilateral Lumbar pain. This pain was mild at first then worsened in the next two weeks also radiating to bilateral hips and buttock. Worsening stiffness and loss of range of motion. Bending over or lifting legs particularly thighs to get in and out of my car was very difficult & painful. Got MRI of the back with was negative.Orthopedic Surgeon?s PA I saw. She felt it was probably a lumbar strain from possible exercise I had done.. Symptoms improved after activity & PT but returned in a day or so & worsened at a night. In the last month spread to shoulders. Got my Internist involved then. Inflammatory markers done 4/13/2021. C Reactive Protein positive at 2.8. Slightly anemia as well. All other markers negative. Polymyalgia Rheumatica diagnosed. Started on Prednisone 20mg 4/14/2021. Symptoms improving greatly.
58 2021-04-25 facial paralysis Patient had the second Pfizer COVID vaccine on 4/20/21 in her left arm. Within 2-3 days, she noticed... Read more
Patient had the second Pfizer COVID vaccine on 4/20/21 in her left arm. Within 2-3 days, she noticed left facial swelling, left facial droop, left ear sensitivity, left eye blurriness. She had a HA for 5 days. She took NSAIDs as needed. States symptoms are persisting.
58 2021-04-25 feeling cold, feeling jittery, pain in extremity 1. left forearm ached 2. very tired 3. jittery 4. very cold 5. felt unlike my self for 2 days
58 2021-04-25 feeling cold, pain in extremity No symptoms after 1st shot - Symptoms started after 2nd shot on 4/20 & some of the symptoms lasted f... Read more
No symptoms after 1st shot - Symptoms started after 2nd shot on 4/20 & some of the symptoms lasted for days - Sore left arm - Massive Headache - Body Aches - Nauseous - Felt like ice cold poison was racing thru my veins - chills like I have never had before, could not warm up - Hives - Bottom lip swelled up - Low Blood Pressure (90/59, 108/65, 115/66, 112/70 - Extreme fatigue
58 2021-04-25 feeling cold Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Letharg... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Nausea-Medium, Additional Details: Patient was heaving about 3 minutes after administration. She started to cough and vomited right after. Her husband helped translate and said she was having difficulty breathing so we administered an epi-pen for 1 dose. She has chills and felt extremely cold. We had her in for observation for 45 minutes and she said she felt better. We advised her husband if she has any worsening symptoms to call 911 immediately.
58 2021-04-25 numbness, facial paralysis, tingling Within minutes (possibly 5) of the injection I tasted medicine in the back of my throat. I parked ou... Read more
Within minutes (possibly 5) of the injection I tasted medicine in the back of my throat. I parked outside of the facility to wait. Within 15 minutes I had difficulty swallowing, tingling in my arms, and my face feeling numb. I got out of my car to breathe in colder air. At around 15 minutes the difficulty in swallowing started to subside so I left the facility. At around 20 minutes my face felt like I had a shot of Novocain that was wearing off. I took a picture of my face in the car (approx 1/2 hour after the shot) because it felt so weird. It appears as if the left side of my face is drooping slightly. This drooping has appeared since then so possibly something I never noticed before or related to the shot, I don't know. I purchased Benedryl and took a dose at approx. 40 minutes after the shot. Symptoms did not reappear.
58 2021-04-25 pain in extremity The next day, just a sore arm. A headache for 16 straight days. I started having a lot of anxiety. I... Read more
The next day, just a sore arm. A headache for 16 straight days. I started having a lot of anxiety. I had to get medication for it. I did an online visit and then I went to NOW clinic to get my blood pressure system checked. My blood pressure was fine. Medicine I was prescribed: Alprazolam. I recovered from my headache just before the second dose of vaccine which was 2/8/2021.
58 2021-04-25 pain in extremity Next day - sore arm. The next day, as well. Then it went away about 24 hours later. The joints in m... Read more
Next day - sore arm. The next day, as well. Then it went away about 24 hours later. The joints in my hips both sides and both of my knees started to hurt so bad. They still hurt. I sold my truck because I couldn't get in and out. I started taking some Glucosamine for joints. Anxiety symptoms after first dose of vaccine had continued and they are still continuing. They have not stopped.
58 2021-04-26 weakness, pain in extremity Was given the Pfizer Biopntech COVID 19 EUA, 1st dose. A few minutes after the shot I started feelin... Read more
Was given the Pfizer Biopntech COVID 19 EUA, 1st dose. A few minutes after the shot I started feeling very very dizzy, and a strong pain down my legs. Could not hold myself up. The EMTs there gave me a wheel chair and took vitals. I felt very weak all the time, like I was going to collapse. and I was breathing heavily. Good news is that my vitals stayed within normal range., and nothing more severe happened (my doctor had said to bring my Epipen, just in case). After about a half hour, I was getting weaker, and the dizziness had not subsided, so they called an ambulance and transported me to the Hospital. The dizziness started to subside after another hour or so. They dismissed me after I was able to walk and was not in danger of falling.
58 2021-04-26 cold sweat Patient felt clammy at back of the head and back. Patient said she was in the process of being teste... Read more
Patient felt clammy at back of the head and back. Patient said she was in the process of being tested for MS. Patient also stated that she has Migraines She is currently on anti depressants for anxiety, cholesterol and migraine medications No aberrations Vitals BP:128/73 sp02: 98% RESP: 14 HR: 90
58 2021-04-26 migraine, weakness vertigo, weakness, migraine within 24 hours of first vaccine administration
58 2021-04-26 nerve pain, muscle spasms Patient is a Spanish speaker, per interpreter, patient is experiencing fatigue, syncope, muscle ache... Read more
Patient is a Spanish speaker, per interpreter, patient is experiencing fatigue, syncope, muscle aches, runny nose, headache, lips are getting dark. No SOB voiced. Recommended to take Tylenol, stay hydrated and an OTC antihistamine, as for the lips becoming dark, I recommended for her to see a medical provider. 4/22/21- Follow Up: Patient stated she is still not feeling so well because of the cramps all her symptoms have subsided besides the nerve pain in her body. She only took tylenol and and takes it every morning and night and it has been helping. She didnt go to an ER/Urgent but she is going to see her PCP on 4/22/21. Advised to continue with the tylenol and will call back on Friday 4/23/21 to follow up and see what PCP advised.4/24/21- Follow up- patient stated she is feeling better and all her symptoms have subsided with the tylenol, no pcp/er visit.
58 2021-04-26 pain in extremity Patient was vaccinated with an undiluted dose of Covid-19 Pfizer immunization. I called patient and... Read more
Patient was vaccinated with an undiluted dose of Covid-19 Pfizer immunization. I called patient and let her know of our mistake and told her that the dosage given was not harmful, but she may have an extremely sore arm. She stated that she did have sore arm with swelling. She took Tylenol and it relieved her symptoms. She states that she is doing great.
58 2021-04-27 pain in extremity Fever, chills ,headache, body aches, nauseousness, arm soreness, increased heart rate, sharp pain in... Read more
Fever, chills ,headache, body aches, nauseousness, arm soreness, increased heart rate, sharp pain in head, exhaustion.Body aches, headaches, exhaustion still experiencing. All other symptoms lasted a day. Took Advil and Tylenol.
58 2021-04-27 pain in extremity General aches; Headache; Left arm pain at injection site; Left arm pain at injection site; This is a... Read more
General aches; Headache; Left arm pain at injection site; Left arm pain at injection site; This is a spontaneous report from a contactable other hcp (nurse). A 58-years-old female patient (nurse) received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 2 intramuscularly administered in Deltoid Left on 20Jan2021 15:40 (Lot Number: EL8982, Expiry date: unknown) as single dose for COVID-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing, obesity from an unknown date and unknown if ongoing, diverticulum from an unknown date and unknown if ongoing, gastro oesophageal reflux disease from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. There was no family history. The patient previously received first dose (Intramuscularly, LOT number: EL1284, Time: 15:40 hh:mm) of COVID vaccine and experienced Left arm sore, Muscle aches, Chills, Fever 101.2. The patient had all childhood vaccines included MMR in 1980, Tetanus booster in 26Oct2018. Concomitant medication(s) included ketotifen fumarate (KETOTIFEN FUMARATE) 1 gtt each eye QD (Once daily) rare taken for hypersensitivity from an unspecified start date from one year ago and ongoing; famotidine (PEPCID [FAMOTIDINE]) 20mg BID (two times a day) taken for gastro oesophageal reflux disease from an unspecified start date from one year ago and ongoing; pantoprazole sodium sesquihydrate (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) 40mg QD (once daily) taken for gastro oesophageal reflux disease from an unspecified start date from one year ago and ongoing; levocetirizine dihydrochloride (XYZAL) 5mg q (Everyday) HS (At bedtime) taken for hypersensitivity from an unspecified start date from one year ago and ongoing; "SENSIMIST FLONASE" 1 puff BID (Two times a day) each taken for oesophageal reflux disease from an unspecified start date from one year ago and ongoing. On 21Jan2021 02:00, the patient experienced general aches, headache, left arm pain at injection site. Side effects occurred day after vaccine and resolved by 2nd day after vaccine. Therapeutic measures were taken with Tylenol and Ice. The outcome of the events were recovered on an unspecified date in Jan2021.
58 2021-04-27 tremor, weakness, feeling hot After administering a covid vaccine, patient reported hot, weak & shaky. Temp: 97.6F ; BP/ HR: 157/9... Read more
After administering a covid vaccine, patient reported hot, weak & shaky. Temp: 97.6F ; BP/ HR: 157/98 (80); 136/86 (79); 150/92 (71) (1-10 min apart)
58 2021-04-27 tremor, involuntary muscle movements Shaking, jerking of whole body. Patient was warm, pink, alert and oriented x4.
58 2021-04-27 tremor, restless legs syndrome after vaccine working arm, all blood in head rushed to feet, lightheadedness, felt like she was goin... Read more
after vaccine working arm, all blood in head rushed to feet, lightheadedness, felt like she was going to drop or die, tremors, body felt like it was growing fur, lymph nodes under tongue, fingers, toes, started to swell.teeth chattering, restless legs, itching legs, sugar swings
58 2021-04-28 feeling hot BP 224/99 P99, patient c/o CP, SOB, and feeling hot, nausea, blurred vision. Started to sweat, MD a... Read more
BP 224/99 P99, patient c/o CP, SOB, and feeling hot, nausea, blurred vision. Started to sweat, MD alerted, patient send out to ED at 1415 via amb.
58 2021-04-28 pain in extremity Extreme arm pit and inside of arm pain. Very very painful.
58 2021-04-28 tingling, numbness At the time of the vaccine, the nurse asked if I'd had allergic reactions to vaccines before and I t... Read more
At the time of the vaccine, the nurse asked if I'd had allergic reactions to vaccines before and I told her about the flu vaccine incident 20 or so years earlier. She raised a red card then left to speak with someone about what to do. They thought it would be ok and that I just need to sit in the lobby for 15 min. After waiting in the lobby for the 15 mins after the shot with no problems, my husband drove us home. About 10 mins into the drive home the left side of my face, under my chin, and the top of my left hand felt numb. That feeling lasted for at least 24 hours. Then I just seemed more tired than usual. However, somewhere a few days after the shot, I began to feel a systemic prickly sensation. I sort of expected a rash or something might be manifesting, but nothing. Had the feeling for about two weeks. Starting this past Sunday, April 25 I noticed the left side numbness back again on my face and arm. I just ignored it all and figured that was normal as the medicine was working. Then, my 31 year old called that following Tuesday and said she was having numbness and tingling that started around week three after her first COVID dose. She saw a doctor before her second dose and wanted to see if it was safe for her to have the next shot. Doc determined paresthesia and thought ok for the next dose. She did get the last dose and the tingling in her face, mouth, and extremities is continuing to this day. She saw her doc this morning and is on a list to see a neuro team in a few weeks with the hope the symptoms will resolve before then. Given my talk with her, I decided to take my symptoms seriously and called the vaccination line and they suggested I consult with my doc. After today, I have cancelled my second dose set for May 1 in order to see how my daughter's COVID issue resolves. Then, will see if my symptoms resolve before considering my second COVID shot. Doc said to monitor symptoms and will follow up more if things progress.
58 2021-04-28 tingling Patient presents to the site for her COVID vaccine. She completed her questionnaire to receive the v... Read more
Patient presents to the site for her COVID vaccine. She completed her questionnaire to receive the vaccine and it was determined that she was eligible. She denies any contraindications at this time. She received her vaccine @ 9:40 am and was seated in the vaccine waiting area. She alerted the nurse that she was beginning to feel dizzy around 9:45 am. At that time this NP was alerted and arrived to patient side. The patient was complaining of dizziness, tingling and swelling to the left side of her face, but denies any trouble breathing or swallowing. She was helped to the floor and laid supine and the first set of vitals were obtained. EMS on scene and they hooked her to their EKG machine which obtained the blood pressure and normal sinus rhythm was noted during the entirety of the episode. Monitored patient in supine position until 9:57 am, then she sat up. She reports that she is diabetic and did not eat this morning, so finger stick was obtained which resulted at 105, orange juice was given to patient upon her request. At 10:03 25 mg of benadryl was given due to patient still complaining of facial tingling. Patient's husband was called at that time. She refused to be transported to hospital by EMS. At 10:16 am patient was up to chair and still complaining of facial tingling, but denies shortness of breath or difficulty swallowing. Husband arrived at 10:25 am and transported the patient by private vehicle to the emergency room.
58 2021-04-28 seizure Had 5 seizures with in 36 hours 5 days after the first vaccine./Other medical history: Seizures; Had... Read more
Had 5 seizures with in 36 hours 5 days after the first vaccine./Other medical history: Seizures; Had 5 seizures with in 36 hours 5 days after the first vaccine./Other medical history: Seizures; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER8727), via an unspecified route of administration on 01Apr2021 13:30 (58-years-old) as single dose for COVID-19 immunization. Medical history included seizure. Patient is not pregnant. Patient had no COVID prior vaccination. Patient was not tested for COVID post vaccination. Concomitant medication included valproate semisodium (DEPAKOTE) for seizure. The patient previously took Paxil and experienced allergies. The patient had 5 seizures within 36 hours 5 days after the first vaccine (06Apr2021 11:45). They had to increase semisodium which has helped keep the seizures at bay. She have not had seizures in two years. Event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of event (Increase in routine medicine). The outcome of the event was recovering.
58 2021-04-29 weakness Light headed, blurred vision, foggy headed & felt medicated, balance off, weakness and dizzy. Starte... Read more
Light headed, blurred vision, foggy headed & felt medicated, balance off, weakness and dizzy. Started after woke up and progressed to the point of having to call husband home because of fall risk. Then fever came. Most concerning and alarming are the symptoms of vision change like smog in front of my eye sight, feeling weak, light headed and dizzy like walking on a rocking ship. Such a medicated feeling, this all progressed from between 7:30 am to about 10:30, had fever come 100.1 dizziness and weakness and vision gradually got better around 11:30. But when fever spiked again in the evening dizziness came back for a hour or more. Next day a milder episode of dizzy and that passed. These are the most concerning symptoms and Doctor advised I do not get second dose. I had many other symptoms and still have some.
58 2021-04-29 weakness Around 2 hrs after receiving the Vaccine I began suffering a very bad headache, severe nausea, vomit... Read more
Around 2 hrs after receiving the Vaccine I began suffering a very bad headache, severe nausea, vomiting, extreme fatigue and weakness, severe body aches, temp between 99 and 100F, severe joint pain(more than normal for me)
58 2021-04-29 pain in extremity Extremely sore arm, severe headache lasting 10 hours then less severe another 3 hours. I was not abl... Read more
Extremely sore arm, severe headache lasting 10 hours then less severe another 3 hours. I was not able to get out of the bed. Migraine medicines (Nurtec and Maxalt) did not touch the headache. I almost went to the ER it was so bad. My doctor said to take Tylenol. I had already taken Ibuprofen 400 mg around 5 p.m. before the doctor's nurse called back and that is the only thing that helped somewhat. Today, 4/30/21, I still have some breakthrough headaches, but not keeping me in the bed.
58 2021-04-29 pain in extremity Vaccine date Fri 4/23/21 Starting at 5pm I had a low grade Fever 99.1 and Chills lasted until appro... Read more
Vaccine date Fri 4/23/21 Starting at 5pm I had a low grade Fever 99.1 and Chills lasted until approx 9pm and then went away. Sat 4/24/21 woke up with Sore L. Arm at site of Vaccine, but felt better. Sun. 4/25/21 woke up at 7:30am and didn't feel well, nausea, chills, needed to lay down, about 8:00am severe Headache at my Sinuses, Behind my Eyes, Forehead, and Back of Head at Base of Neck through 10pm. I took Speedy Release Tylenol, 3 hrs later Headache was returning I took 2 Ibuprofen and slept. Slept most of the day until 9pm when I felt I could tolerate Chicken Noodle Soup. I woke up Mon. 4/26/21 w/mild Headache just behind my Eyes.
58 2021-04-29 slow speech, discomfort, weakness, tenderness This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose ... Read more
This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose Pfizer on 4/27/21 (Lot# EW0151). Of note, the patient was in a motor vehicle accident on 4/12/21 with a diagnosis of concussion and cervical/thoracic strain/sprain (see history under patient information). On 4/29/21, the patient's sister contacted the patient's primary care clinic with the following documented concern: "Pt's sister calling to report that two days ago pt got 2nd dose Pfizer vaccine and has been sick. This morning they found her passed out against the her bedroom door. Pt reports that she can't remember much other than going to the bathroom. Pt's sister states that patient totaled her car a week ago, and that it was determined she had a concussion. "She hasn't been herself since the wreck and I am very concerned." This caller recommenced the Ed or UC but caller denied stating that either needs to see her today. This writer is reaching out to nurse to see if they can advise from here." A RN assessed the patient virtually with the following documentation: "RN note: Call transferred from patient's sister. Pt noted to be found on her floor this morning. Pt unsure if she hit her head. Spoke to patient. She reports body aches, and feeling weak. Pt is slow to answer questions, and had a lot of difficulty hearing me (sister did not have any difficulty hearing me). Pt is noted to have more rapid breathing, and some slight wheezing. Speech is clear when she is speaking. Sister gave patient water to drink. She drank out of bottle and was able to hold on her own (though had difficulty with this at first). Sister noted some water dripping down face, but was able to swallow okay. Sister also noted that patient's lips seem to be pursed. Plan: Given recent concussion, and patients change in behavior per sister (pt more irritable, speaking more slowly, moving slowly, breathing faster, and wheezing), recommended patient be taken to the ED today--recommended ambulance since it took 2 men to help patient back to bed this morning. Sister states patient is not agreeable to going to ED at this time. Advised to try to encourage her to drink more fluids, and continue to monitor her sxs, and if any worsening, to call for ambulance transport. Sister agreeable to plan, and will discuss with sister, and recommend ED visit today." On 4/30/21, the patient's sister contacted the clinic to inform them that the patient was found dead that morning. The medical examiner is completing the further investigation. If additional information is needed from the primary care physician for this patient.
58 2021-04-30 pain in extremity about the size of a quarter it is all red; it looked like it took patient skin off; raw skin; notice... Read more
about the size of a quarter it is all red; it looked like it took patient skin off; raw skin; noticed it was hurting; looks like it was bleeding; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Lot Number: ER8729; Expiration Date: 31Jul2021) at age of 58 years old, at single for covid-19 immunisation. Medical history included Pre-diabetes. The patient's concomitant medications were not reported. The patient got the shot on 09Apr2021, about the size of a quarter it was all red, it looked like it took patient skin off, it is raw skin. It is of the size of a quarter of the skin it is all red, looks like it was bleeding. She just noticed it today(13Apr2021). she did not take the bandage off, today she took the bandage off and noticed it was hurting. So, she took the bandage off off it is the size of a quarter. It is all red and skin is off. Patient request What should do now. just put 'Pyridoxine'? (further clarification unknown)." The patient had the blood work done after the vaccine. No treatment received for the events. Outcome for events was unknown. No follow-up attempts needed. No further information expected.
58 2021-04-30 pain in extremity sore throat; Sore Arm; Chills; fever 102; extreme tiredness; This is a spontaneous report from a con... Read more
sore throat; Sore Arm; Chills; fever 102; extreme tiredness; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of bnt162b2 via unspecified route of administration in left arm on 09Apr2021 12:00 (Lot number ER8737) at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included pleurisy, COVID-19 diagnosed prior to vaccination. The patient had no allergy to medications, food, or other products. The patient's concomitant medications included estradiol (ESTROGEN), celecoxib (CELEXA), methylphenidate hydrochloride (CONCERTA). The patient previously received the first dose of bnt162b2 via unspecified route of administration in left arm on 16Mar2021 11:00 AM (Lot number EP7534) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Apr2021 20:00, the patient was experiencing sore arm, chills, fever 102 F, and extreme tiredness. On 12Apr2021 12:00, the patient was experiencing sore throat. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving. No follow-up attempts are needed. No further information is expected.
58 2021-04-30 pain in extremity Nauseated, heart racing, arm pain, muscle aches throughout body, vomiting, extreme headache, extreme... Read more
Nauseated, heart racing, arm pain, muscle aches throughout body, vomiting, extreme headache, extreme fatigue, chills and fever. At the moment going on 5 days Ist one on 4/06/2021 was nauseated arm pain and fatigue for the first week second week arm turned red and swollen third week got a bruise and when they gave me the second shot they still saw the bruise on the right arm
58 2021-05-01 tremor, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting /... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild
58 2021-05-02 numbness Pt complained of dizziness and facial numbness. EMS responded, BP 145/83, HR 78, O2 97%. Pt refused ... Read more
Pt complained of dizziness and facial numbness. EMS responded, BP 145/83, HR 78, O2 97%. Pt refused transport. Symptoms unimproved with snacks/water, pt referred to PCP/urgent care if symptoms do not resolve.
58 2021-05-02 migraine, weakness I started getting a horrible migraine/sinus pain headache early evening the day of the vaccine. The... Read more
I started getting a horrible migraine/sinus pain headache early evening the day of the vaccine. The left side of my face had tremendous pressure. The pounding in my head was so intense it upset my stomach to the point of nausea. The pain also went down into my neck. At around 10am the next day it finally subsided. I did take Ibuprofen around 8am that morning. I felt completely drain that entire day and evening. Also I had arm tenderness at the area around the vaccine. I did arm raises through the day to help keep arm pain down and it helped. The arm tenderness is still occurring 2 days after the shot (which is the day I am filling out this form).
58 2021-05-02 migraine 1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlarge... Read more
1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlargement. 3rd day after vaccine left ear pain, difficulty swallowing, but could breath, fever,migraine, chills, ,fatigue, tender breast, breast enlargement. My primary said not to get second dose. Also rash on right arm.
58 2021-05-02 pain in extremity My arm hurt really bad for two, so much so that it woke me up at night. The pain subsided to minimal... Read more
My arm hurt really bad for two, so much so that it woke me up at night. The pain subsided to minimal and then became constant. Now I can't raise my elbow very high without pain, I have to ice my arm nightly before bed, it is stiff and very painful in the morning. My doctor told me to see a orthopedic doctor; have an appointment on 5/4/2021.
58 2021-05-02 tenderness Received second shot on Thursday (4-29-21) Woke up with symptoms on Friday(4-30-21). Left arm rednes... Read more
Received second shot on Thursday (4-29-21) Woke up with symptoms on Friday(4-30-21). Left arm redness and tenderness that's spreading down my arm. It's hot to touch. Fatigue Chills Fever Nausea. Has not gotten better (5-3-21)
58 2021-05-02 tremor, tension headache, tingling, pain in extremity, numbness As reported by patient: tension headache and neck pain before leaving the clinic, advised to take Ty... Read more
As reported by patient: tension headache and neck pain before leaving the clinic, advised to take Tylenol and drink water at home, several hours later, patient noticed her R arm was "contracted" in elbow flexion and tremors in R arm began. Patient took Tylenol daily for 1 week without resolution of symptoms. One week later, patient went to emergency department, where she was screened for stroke due to history of stroke resulting in R hemiparesis in 2018. Patient began noticing numbness/tingling in R arm, elevated blood pressure, and blurry vision. Patient was given tramadol for her R arm pain while being observed in the hospital. After discharge, patient went to the emergency department at Hospital (4/21) due to continued pain and tremors. Patient was prescribed flexiril and ibuprofen. On 4/23, her PCP prescribed Tramadol. Patient reports no change in R arm pain. Patient reports R arm tremor is improving, but still significantly affecting her.
58 2021-05-02 tremor Patient started having extreme tremors starting Sunday, 2 days after receiving the second dose. She... Read more
Patient started having extreme tremors starting Sunday, 2 days after receiving the second dose. She had to take Ativan to lessen the effects of the tremors on Monday. This also happened with the first dose and did not fully recover. It was really severe on Sunday and Monday was more tolerable. Upon physical exam, the tremor is pronounced and effected daily activity
58 2021-05-03 weakness, numbness, tingling, involuntary muscle movements The patient received her second dose of the Pfizer COVID vaccine around 8 a.m. on 5/3/21 in one of o... Read more
The patient received her second dose of the Pfizer COVID vaccine around 8 a.m. on 5/3/21 in one of our outpatient clinics. She reported no reaction after her first dose of Pfizer vaccine. Within 20 minutes of receiving the dose, she had some numbness, tingling and uncontrollable jerking movements. She also had some blueish discoloration of toenails. Patient was reportedly weak and had to have assistance getting up onto stretcher prior to transport to hospital ER. Patient also reported "full" feeling in her throat that resolved after being given benadryl IM prior to arrival of EMS. She denied Shortness of breath. Patient was transported to ER and was noted to have dystonia. Patient was given benadryl and cogentin injection for jerking movements. Dystonia improved some, but patient was admitted to hospital for observation. After 24 hours, patient reports dystonia is better but is having some cerebellar issues probably due to medications that were given to stop the dystonia. MRI is to be done and neurology will be consulted.
58 2021-05-03 weakness Chills started Saturday evening around 8:30 pm and continued until early Monday morning 1:00am Slep... Read more
Chills started Saturday evening around 8:30 pm and continued until early Monday morning 1:00am Slept on & off the entire time Fever started around 3:00am and continued till around 9:30 am. Woke with severly chapped lips, wet and extremely week. Bad headache & sensitve to light and noise mostly all day Sunday body aches and fatigued starting to fade today Tuesday, May 4th
58 2021-05-03 numbness, tingling Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic visit with primary care provider 19... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic visit with primary care provider 19 days after vaccination to report numbness and tingling on left side of face that started on the drive home from vaccination site. Symptoms resolved without treatment within 24 hours. Since then reports a prickly feeling around the body and within the last four or five days numbness and tingling has returned. The patient's daughter experienced same reaction and the second vaccine dose exacerbated symptoms resulting in follow-up with neurology.
58 2021-05-03 pain in extremity, weakness pt had pain in her right arm, headache, scratchy and fatigue the day of getting the vaccine. The pa... Read more
pt had pain in her right arm, headache, scratchy and fatigue the day of getting the vaccine. The pain in her arm and the fatigue was getting worse. Her left arm and hand started hurting and she had tightness across her back. Her had pain in the left elbow. The pain was causing her a headache and to be nauseated. On 4/8/2021 she went to Healthcare ER. She had blood test and covid test with negative results. She had an X-Ray of the elbow. She was given medicine for pain and nausea. She was diagnosed w/ Arthritis of the elbow which she has never had before. She was told to FU w/ PCP. She saw her PCP the next week. She was told to continue to take some pain meds she was already prescribed. On 5/4/2021 the patient is still feeling very weak and fatigued all of the time. She still has pain in her both arms. She says the arms are weak and heavy feeling. She is finding it hard to function at the level she was before getting her 2nd dose of the vax because she gets too weak and tired.
58 2021-05-03 tremor After 12 hours: headache, fatigue. By 48 hours post vaccine: nausea, fatigue. 72 hours post vaccine:... Read more
After 12 hours: headache, fatigue. By 48 hours post vaccine: nausea, fatigue. 72 hours post vaccine: severe diarrhea, fever, shaking, aches, vomiting and nausea, headache. 4 days post vaccine: headache and diarrhea.
58 2021-05-04 numbness, tingling Woke up early morning on March 27, 2021 with my entire leg numb, tingly and rubbery on my right-side... Read more
Woke up early morning on March 27, 2021 with my entire leg numb, tingly and rubbery on my right-side. Called the nurse on the back of my insurance card and was told to go to the emergency room. CT scan indicated slight bulging disc. Later that day, the numbness and tingling moved up into my stomach and ribs. The feeling of numbness was around the back of my body on my right-side in the next few days. I had tingling in my left foot which has now moved into the calf area. Also, numbness in the private areas. Was sent home with instructions to see my primary care doctor, which I did, and was sent to physical therapy. I have also been going to the chiropractor. Continue to have numbness and tingling in all these areas. I am using a cane. I am unable to drive.
58 2021-05-04 migraine migraine; This is a spontaneous report from a Pfizer-sponsored program Eliquis patient Ambassador Pr... Read more
migraine; This is a spontaneous report from a Pfizer-sponsored program Eliquis patient Ambassador Program from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 24Mar2021 for covid-19 immunisation. The patient experienced migraine on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
58 2021-05-04 pain in extremity Next day had diarrhea x2; abdominal cramping; mild GI upset for 2 more days; sore arm; chills; fever... Read more
Next day had diarrhea x2; abdominal cramping; mild GI upset for 2 more days; sore arm; chills; fever around 12 MN, fever 102.0; severe nausea; vomiting x1; severe H/A; body aches; stomach cramps; This is a spontaneous report from a contactable Nurse (patient herself). A 58-years-old non-pregnant female patient received second dose via bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262) via an unspecified route of administration, administered in Arm Right on 26Jan2021 at 11:00 as SINGLE DOSE for COVID-19 immunization. Medical history included arthritis, depression and the patient had covid prior the vaccination; Known- allergies included: Penicillin, flagyl, Clindamycin and the patient previously took flagyl [metronidazole] and clindamycin and experienced drug hypersensitivity. The patient previously took first dose of BNT162B2 (BNT162B2,Solution for injection, Lot number: EL3246), via unspecified route of administration to the Left arm on 05Jan2021 at 14:00 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks. Concomitant medication(s) within-two weeks included sertraline hydrochloride (ZOLOFT); lithium (LITHIUM); ergocalciferol (VITAMIN D [ERGOCALCIFEROL]); docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]). On 26Jan2021 at 17:00, the patient experienced sore arm, started having chills, fever around 12 MN, fever 102.0, severe nausea, vomiting x1, severe H/A, body aches, stomach cramps. Severity subsided at 36 hours. Next day had diarrhea x2 and abdominal cramping, mild nausea, mild GI upset for 2 more days. The events resulted in a Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included fever: 102.0 on 26Jan2021 fever around 12 MN. The patient had not tested covid post vaccination. The patient did not received any treatment for the events. The outcome of the events was recovered on an unspecified date. Follow-up attempts are completed. No further information is expected.
58 2021-05-04 pain in extremity Pt presented with persisting right leg pain that seemed to spread to the hip. Pain appeared approxim... Read more
Pt presented with persisting right leg pain that seemed to spread to the hip. Pain appeared approximately 1 day after receiving second dose of Pfizer COVID vaccine. Second dose received on 4/29/2021. Additionally, the patient experienced fever, chills, and fatigue, which had resolved by her presentation to the clinic on 5/3/2021. Pt noted the pain was partially positional, but was constant and found little relief with tylenol purchased over the counter. On physical exam, swelling of the lower extremity was noted with decreased hip ROM. Pain was ellicted on palpation of the calf. No erythema was noted. Pt was sent for Venous Duplex Ultrasound of both legs which was positive for deep vein thrombosis in the right leg.
58 2021-05-04 tingling, flushing, feeling hot 10 minutes after receiving the injection patient reported facial flushing with feeling of heat, naus... Read more
10 minutes after receiving the injection patient reported facial flushing with feeling of heat, nausea, headache, weird taste dry mouth, and tingling in fingers. Vital signs at 1328: HR 84 BPM, O2 95%, Respirations=16, BP 130/80 (manual in R arm). Called overseeing physician who instructed us to monitor patient for an additional 10 minutes, record another set of vitals and reports back change in s/s. At 1338 patient said all symptoms had resolved with vitals of HR 85 BPM, O2 95%, Respirations= 15, BP 128/86 (manual in R arm). Report was called to physician who allowed the patient's spouse to drive her home. Both patient and her spouse were instructed to seek emergency medical attention if symptoms returned/wrosened.
58 2021-05-04 tremor Description of events: Increased HR, c/o SOB, shakiness, c/o difficulty swallowing after receiving ... Read more
Description of events: Increased HR, c/o SOB, shakiness, c/o difficulty swallowing after receiving vaccine Intervention: cool towel behind neck, car seat reclined VS checked, 30min monitoring No noted respiratory distress. Pt stated, "this reaction is like when I get I.V dye but not as severe." 1425 BP 146/88 1455 BP 110/60 P 88
58 2021-05-05 feeling cold I got my 1st dose at 9:35 A.M., then at 5:00 P.M. I started to felt slight fatigue, then continued t... Read more
I got my 1st dose at 9:35 A.M., then at 5:00 P.M. I started to felt slight fatigue, then continued to super fatigue. I took my blood pressure, first it reach 150/84, then 20 minutes after it reached 160/90 which made me concerned. And I was so real fatigue. So I lay down. The whole night of 4/12/21, my BP was high 145/84, 150/84. I had a slight feeling of body cold, so i dressed warm. The following day which is 4/13/21, my BP is still high in between 140/84 to 150/84. On 4/14/21, my BP was 145/84 which a bit bitter compared to the previous days.
58 2021-05-05 pain in extremity, muscle spasms frequent short duration intense headaches few times a week, bouts of dizziness lasting less than a ... Read more
frequent short duration intense headaches few times a week, bouts of dizziness lasting less than a minute every other week in addition to the original day after vaccine symptoms of flu-like aching and cramping leg, calf and feet muscles, fever of 101.3, intense pressure headache which lasted approximately 36 hours, sore arm when injection was given.
58 2021-05-06 electric shock sensation First 30 minutes: Dizziness, extreme fatigue to the point of not being able to stand, confusion. Cou... Read more
First 30 minutes: Dizziness, extreme fatigue to the point of not being able to stand, confusion. Couple of hours later: intermittent waves of extreme fatigue, confusion. Felt like nervous system was electrified. Next 24 hours: Continued extreme fatigue, headache, waves of extreme confusion. Waves when nervous system felt shocked. 2 days after vaccine: morning was still difficult with waves of confusion, extreme fatigue, dizziness, and nervous system shocks. It's now 52 hours later. Head is clearing but still not feeling well.
58 2021-05-06 flushing Flushed face, had to clear throat a lot, cough, blood pressure high and short of breath, hard to bre... Read more
Flushed face, had to clear throat a lot, cough, blood pressure high and short of breath, hard to breath. They gave me Benadryl which only worked a short time. Then got a shot of Epinephrine.
58 2021-05-06 pain in extremity, weakness i had the second shot on friday, besides arm hurting, didn't really feel bad until monday, had fever... Read more
i had the second shot on friday, besides arm hurting, didn't really feel bad until monday, had fever hovering over 100, chills, feeling wiped out, no energy, painful glands, continue feeling more or less the same from monday thru wed. fever down by wednesday, had bad headache on thursday and friday. still struggling with a headache as i type...hope it'll go away soon.
58 2021-05-07 bell's palsy Mild case of Bell?s palsy
58 2021-05-07 tingling Patient states that she is anxious and is experiencing tingling in her legs. Her legs checked and ap... Read more
Patient states that she is anxious and is experiencing tingling in her legs. Her legs checked and appear normal. Her vital was checked BP 122/84 O2 sat 98 HR 80 She appeared normal and she was released to go home.
58 2021-05-07 tremor I started to feel injection site pain and a headache approximately 4 hours after the injection. I th... Read more
I started to feel injection site pain and a headache approximately 4 hours after the injection. I then went to bed. I woke up at 5 AM and couldn't get back to sleep. I had an extremely severe headache. shaking chills, fever (fluctuated between 101 and 102) and severe fatigue and muscle and joint pain. Muscle and joint pain was primarily in my neck, shoulders, back and chest. It hurt to open my eyes or even move. I had no appetite and wasn't eating or drinking, but I urinated a lot, so I knew I was getting dehydrated. I tried to drink sips of water and managed to keep it down, until 11 PM on the day following the shot, I vomited and became nauseated. I had a hard time sleeping again. I woke up on the second day after the shot with a lingering headache and fatigue, but my fever was gone and I could move more easily. I gradually improved throughout the day. It doesn't sound terrible as I'm reading/writing this, but for about 36 hours; I haven't been that sick since I was a child, I don't think. It made me not want to have a booster shot if it's needed later. If I have to; I'll definitely need to have it on a Friday. I'm so jealous of people who've said they had no side effects or very mild ones. I had to take two days off work. I have to say though that although the side effects were severe and came on fairly quickly; they were also nearly all gone 48 hours after the shot. I felt so awful, it seemed like longer than 36 hours of misery, but in reality it wasn't.
58 2021-05-08 bell's palsy Bells palsy
58 2021-05-08 tenderness DAY AFTER SECOND DOSE - GOT CHILLS/FEVER/HEADACHE SEVEN DAYS LATER DEVELOP SEVERE HEADACHES, FEVER B... Read more
DAY AFTER SECOND DOSE - GOT CHILLS/FEVER/HEADACHE SEVEN DAYS LATER DEVELOP SEVERE HEADACHES, FEVER BLISTER -CANKER SORE IN THE RIDE SIDE OF MY CHIN - CHILLS/FEVER 101-103 - SWOLLOW LYMPH NOSE AND KNOTS IN THE BACK OF NECK AND TENDER RISE INTHE LEFT SIDE MY HEAD.
58 2021-05-10 weakness Horrible nausea and vomiting, high fever, chills with shaking, body aches all over my boy especially... Read more
Horrible nausea and vomiting, high fever, chills with shaking, body aches all over my boy especially where I have had previous injury or surgeries. Really bad headache. I could not drink much even though I was thirsty. I could only do a small sip at a time or risk vomiting. My urine started to turn brown due to lack of hydration most likely. I was really sick for 3 days and mildly for 2. I still feel very weak and have brain fog.
58 2021-05-10 bell's palsy After the second dose I had fever, body aches and swollen lymph nodes. I went to the doctor and got ... Read more
After the second dose I had fever, body aches and swollen lymph nodes. I went to the doctor and got antibiotics. Nine days after the vaccine I got Bells Palsy and I have not been able to work since then. I noticed when I gargled that night the water was coming out. The following day was a holiday and everything was closed. I was able to see my doctor. My left eye was not closing and I had difficulty eating because the left side of my face was effected. I had to tape my eye shut at night. It is very sad and upsetting because I don't know if it will get better. I have seen a Neurologist. It has been four months and I am still getting therapy for the Bells Palsy. Physical therapy since 04/19/2021 with electrical stimulation. My eye closes a little better and my smile is a little straighter.
58 2021-05-10 pain in extremity developed patches of rash; developed aches; chills; fevers; her arm is still sore; This is a spontan... Read more
developed patches of rash; developed aches; chills; fevers; her arm is still sore; This is a spontaneous report received from a contactable consumer or other non hcp. A 58-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8734; Expiration Date: Jul2021), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history included influenza from an unknown date and unknown if ongoing it occurred 20 years ago. Mentioned allergy to Flu shot on initial report. Has no NDC/LOT/EXP for Flu shot and it occurred 20years ago. She doesn't think she is allergic to the things in the COVID shot. She was allergic to the flu shot. Was told to never take the Flu shot again. The patient's concomitant medications were not reported. Patient received her first dose of the Pfizer BioNTech COVID-19 vaccine 36 hours ago. Approximately 7 hours later she developed patches of rash here and there and developed aches, chills, fevers and her arm is still sore. The outcome of the events was unknown. Requested medical information if there is something she can take before the second COVID shot so the side effects are not as bad like a Benadryl. No follow-up attempts are needed. No further information is expected.
58 2021-05-10 seizure, involuntary muscle movements Twelve hours after the second shot, I had convulsions; About 5 hours after the second shot, my lips ... Read more
Twelve hours after the second shot, I had convulsions; About 5 hours after the second shot, my lips started to swell; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; Then my body would jerk and I groaned; Then my body would jerk and I groaned; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0169) at left arm on 24Apr2021 09:45 AM at second dose, single for COVID-19 immunisation. Medical history included chronic rhinitis and Lyme disease. Patient previously received Morphine, cefzil and grass. Patient previously received the first dose of BNT162B2 on 03Apr2021 09:45 AM (lot number: EP7533) on Left arm for Covid-19 Immunization. Concomitant medication included loratadine, astaxanthin (BIOASTIN), spirulina spp. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 5 hours after the second shot (also reported as 24Apr2021 22:00), her lips started to swell. she took her allergy medicine and she felt better. Twelve hours after the second shot, she had convulsions. she had a pain that started in her left armpit, shot down to her inner elbow, and caused her whole arm to get rigid. Then her body would jerk and she groaned. It stopped and started in intervals, with calm in between. It was unknown prior to vaccination, if the patient diagnosed with COVID-19. Not tested for COVID-19. Outcome of the events was recovering. Follow-up information requested.
58 2021-05-12 discomfort a rash on her upper left thigh; shingles; blisters; discomfort; redness/color is reddish to Peach re... Read more
a rash on her upper left thigh; shingles; blisters; discomfort; redness/color is reddish to Peach red now; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6206 and expiry: 30Jun2021), via an unspecified route of administration in left arm (upper) on 11Mar2021 (at the age of 58-years-old) as 1 st dose, single for covid-19 immunisation. The patient had no medical history. The patient's concomitant medications were not reported. On 13Mar2021, the patient woke up and noticed a rash on her upper left thigh and it was a rash like she had never seen before and had it after the vaccine. The patient called the doctor then had virtual appointment after and they said it looks like shingles. Diagnosed with shingles by her HCP in Mar2021. The patient stated it was not a bothersome rash and progressively got better. If she had not seen the rash, she would not have known it was there, describing the rash as a nuisance. Her HCP told to call Pfizer to verify if she could get the second dose on 01Apr2021, wanted to verify if it was okay to have the second shot. They appeared almost like little blisters (in Mar2021) and according to her doctor she also had shingles looking rash but it was a mild case of shingles. She felt not more of pain but more of discomfort, she still has redness of it until now, before they elevated like blisters but now they were flat and the color was reddish to Peach red now in Mar2021. No treatment for the for the events as stated, "I didn't do anything". The outcome of erythema was not recovered while for the remaining events was unknown.
58 2021-05-12 numbness and pain in extremities, tingling 24hrs after shot #2 (4/7/2021 had low grade fever 99.6 on and off for day. Also had sharp muscle pai... Read more
24hrs after shot #2 (4/7/2021 had low grade fever 99.6 on and off for day. Also had sharp muscle pain on right shoulder/back. 2 days later had painful neuropathy radiating down right arm to fingers. The "heavy arm" arm and neuropathy pain has subsided in arm- however I have painful burning neuropathy in my pointer and middle finger. and Thumb occasionally. My fingers feel tingly, painful, cold and as if I slammed them in a door. This has not subsided in a month.
58 2021-05-12 pain in extremity On the day after my second Covid vaccine (03/26/2021) I had headache and fatigue. On 04/10/2021, I... Read more
On the day after my second Covid vaccine (03/26/2021) I had headache and fatigue. On 04/10/2021, I started noticing a lot of bruising all over my body (petechiae and a lot of other areas of bruising) and I had a lump and pain behind my left calf. I had some fatigue, but otherwise felt fine. I went to the Emergency Department on April11th thinking that my INR was too high since I?m on a blood thinner medication. The ER did an ultrasound of my legs and no blood clots were found. They did a CBC and I had a platelet count of 6,000. They admitted me, gave me a platelet transfusion and a steroid injection. They discharged me from the hospital on 04/12/2021 on 60 mg of Prednisone and to follow up with my hematologist, MD. My platelet count has since returned to normal. I am having a CBC once a week and tapering off the Prednisone. Both Dr. and my Rheumatologist, MD believe that my severe drop in platelets were due to the Covid vaccine causing my Lupus to become very active and attack my platelets. Please feel free to contact me if you have any additional questions. Thanks you,
58 2021-05-12 tenderness, tingling, pain in extremity, feeling cold I did get the normal "side effects" sore arm for a couple of days, body aches, headache and dizzines... Read more
I did get the normal "side effects" sore arm for a couple of days, body aches, headache and dizziness. Then on 3rd-4th day after vaccination I felt some tingling, tender and cool sensations in my feet. Sometimes the tingling is in my lower legs. I have a history of possible "mild" Guillain-Barre from a Tetanus shot and Parvo Virus 22 years ago. I visited my primary care doctor on the 4th of May and she suggested to wait an extra 3 weeks before getting the 2nd Covid Vaccination and to make sure that these symptoms go away first.
58 2021-05-13 numbness Per recovery RN notes: Patient stated nose is "feeling numb". No other symptoms noted. Instructed pa... Read more
Per recovery RN notes: Patient stated nose is "feeling numb". No other symptoms noted. Instructed patient to remain in waiting room until symptoms subsides. At approximately 1350, patient stated feeling "numb and stuffy, and lightheaded". SPO2 at 99% room air. Pulse rate at 61bpm. No new symptoms noted at 1407. Will continue to monitor. Per patient, lightheadedness subsided at approximately 1415. Stated "numbness and stuffy nose" improving. At approximately 1445, patient stated symptoms subsided. Patient left facility at 1446, in stable condition.
58 2021-05-13 pain in extremity 58F w/o significant PMHx presenting to ER with arteriolar thrombosis. Two weeks prior, pt developed ... Read more
58F w/o significant PMHx presenting to ER with arteriolar thrombosis. Two weeks prior, pt developed swelling and pain in left foot (~1 week post vaccine #2). She went toto urgent care and was prescribed ketoconazole cream. She then developed multiple ulcers on her left foot. She presented to ED on 5/12/21. Arterial duplex reviewed complete occlusion of mid-distal SFA into the popliteal and posterior tibial arteries. Pt now returned and ready to be admitted. Of note, pt is a 20 year smoker, half pack a day. Denies any personal or family hx of previous clots. Arterial duplex reviewed complete occlusion of mid-distal SFA into the popliteal and posterior tibial arteries
58 2021-05-14 burning sensation, tingling, electric shock sensation Strong pain; Burning in legs, arms and different part of the body; Pins and needles in different par... Read more
Strong pain; Burning in legs, arms and different part of the body; Pins and needles in different parts and electric shock sensation; Pins and needles in different parts and electric shock sensation; Neck lymph nodes inflammation; Body temperature swings from cold to hot and the other way around; This is a spontaneous report from a contactable consumer (patient, reported for herself). A 58-year-old female patient (who was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0171 expiry date: unknown) dose 2 via an unspecified route of administration in left arm on 29Apr2021 01:15 PM (at the age of 58-years-old), as single for Covid-19 immunization. The patient did not have any medical history. She had known allergies: hives with yellow fever vaccine 7 years prior to this re-port. Concomitant medication in two weeks included EMERGEN-C (MINERALS NOS, QUERCETIN, THIOCTIC ACID, VITAMINS NOS). The patient received first dose of BNT162B2 (solution for injection, lot number: EW0151 expiry date: unknown) via an unspecified route of administration in left arm on 08Apr2021 01:15 PM (at the age of 58-years-old), as single for Covid-19 immunization. She did not receive any other vaccine same date of suspect product or within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 05May2021 09:00 AM, She experienced extremely strong pain and burning in legs, arms and different part of the body, pins and needles in different parts and electric shock sensation, neck lymph nodes inflammation, body temperature swings from cold to hot and the other way around. This was the second day, and she did not have relief yet. It was stated that Tylenol 500mg and Ibuprofen 200mg did not relief absolutely anything. On an unknown date, the patient was hospitalized. The patient did not receive any treatment for other events. The patient underwent lab tests and procedures included Body temperature: swings from cold to hot on 05May2021. The outcome of all events was not recovered.
58 2021-05-14 migraine, tenderness, tingling, numbness Swelling feet and hands; Tingling and numbness in my entire body, in the face, arms, leggs etc/pins ... Read more
Swelling feet and hands; Tingling and numbness in my entire body, in the face, arms, leggs etc/pins and needles; Tingling and numbness in my entire body, in the face, arms, leggs etc; Migraine; Muscle pain; Tiredness; Chills; Nausea; Dizziness; Strong flue like symptoms; short breath; severe headache; tenderness/frozen arm; unable to move left arm where it was vaccinated; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm at the age of 58-years, on 14 Apr 2021 at 11:00 at a single dose at left arm for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported.no known allergies. she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. it was unknown whether the patient was patient diagnosed with COVID-19 Prior to vaccination. Since the vaccination,the patient has not been tested for COVID-19. on 14 Apr 2021 02:00 PM, the patient experienced Tingling and numbness in entire body, in the face, arms, legs, unable to move left arm where it was vaccinated, migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands. She also felt flue like symptoms, tenderness/frozen arm, tingling and numbness all over the body even face, mouth. Like pins and needles, swelling hands and feet, short breath, dizzy, nausea, severe headache. There was no treatment received for the events. The outcome of events migraine, muscle pain, tiredness, chills, nausea, dizziness, swelling feet and hands Was not recovered; whereas the outcome of other events was reported as Recovered/Resolved with Sequel. No follow-up attempts are needed. No further information is expected.
58 2021-05-14 pain in extremity painful to move left side of body; left sore arm; hurt her back; Headache; Dizzy; hallucinating/ hal... Read more
painful to move left side of body; left sore arm; hurt her back; Headache; Dizzy; hallucinating/ hallucination; Nauseated; the lady shot her arm, she said ouch; hadn't eaten a whole lot; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in upper left arm on 27Apr2021 11:30 (Batch/Lot Number: ER8729) (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing back problems started a good 20 years ago in 2001. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2, via an unspecified route of administration, administered in left arm on 06Apr2021 (Batch/Lot Number: ER8727) (at the age of 58-years-old) as a single dose for COVID-19 immunization and she had a sore arm on 07Apr2021 and that's about it. The patient was hallucinating last night and had a left sore arm on 28Apr2021 and painful to move the left side of body on 29Apr2021. After the lady shot her arm, she said ouch on 27Apr2021. The first lady didn't hurt, but whatever the second lady did, maybe hit a nerve or whatever. It was scary. She had never had hallucinations before. The patient felt that she was wasted and not wasted, and that's how she felt today. The patient did not have her glasses as she had been laying in bed. She hated wearing glasses. After the second shot, the patient clarified that it was hard to move. She had so much pain. She clarified that she was not paralyzed but it hurt to move that side. Maybe she was trying to compensate, because she received the shot in the shoulder area and maybe hurt her back that way on 28Apr2021. Last night she woke up because she had s tornado alert. An amber alert went off on her phone that was in the kitchen. It scared her, she realized there was a tornado warning sent to everyone. She took her purse and dog under the table and was she was cramped; this made it all worse. She felt the same, as the hallucinations today. She was not sure where she was, what date it was, scary stuff. Her symptoms started Tuesday, late in the evening and continued to get worse. Yesterday, she felt that she threw out her whole back. When she went to move, she could barely move and it was getting worse this morning. The patient could barely lift the telephone to her ear on that side. It was persisting pain and she laid on the keypad all night. She had a headache on 28Apr2021. It radiated to her neck from her shoulder and down. The shot made it worse she thought since the neck muscle went to the arm, maybe. Her arm was really bad last night and was ongoing with no relief. She took methocarbamol (ROBAXIN) and that didn't help. The patient tried to prevent moving her arm, and thought she threw her back out like that. The patient got up on the call and got really dizzy after getting up on 28Apr2021. The patient hadn't eaten a whole lot in Apr2021. She felt the shot kicked her butt after she texted her daughter and had the arm pain for a couple days. She couldn't and didn't want to get out of bed. She was pretty bummed right now. She was nauseated on 27Apr2021 and it's been off and on, but on for longer and was persisting. Yesterday she did not lay around like she had today. The patient underwent lab tests and procedures which included weight: between 147-148 pounds on an unspecified date. Therapeutic measures were taken as a result of left sore arm. The outcome of events, painful to move left side of body, left sore arm, hurt her back, headache, dizzy and nauseated was not recovered; the outcome of event, hallucinating/ hallucinations was recovered on 29Apr2021; the outcome of events, the lady shot her arm, she said ouch and hadn't eaten a whole lot, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021482506 same patient/drug, different event/ first dose
58 2021-05-15 burning sensation Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (speci... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: PATIENT CALLED AND COMPLAINED OF REDNESS, ALMOST SCALDING LIKE THE FIRST NIGHT FOLLOWING VACCINATION ON HER NECK AND CHEST, AND RED, BURNING ON THE 12 OF MAY, LIKE SHE HAD BEEN IN THE SUN. ADVISED TO TAKE BENADRYL AND APPLY COOL COMPRESSES TO AREA. PATIENT TRIED NOTIFYING MD
58 2021-05-15 tremor Approx 48 hours after receiving vaccination, I developed uncontrollable shaking for 30 mins. It felt... Read more
Approx 48 hours after receiving vaccination, I developed uncontrollable shaking for 30 mins. It felt like it was coming from the inside and working its way across my body. It tensed by abdomen and back muscles so tightly the pain was excruciating . jaw and limbs were also tremoring. I'm a super fit person run, swim, lift weights, hike 4-6 times per week so I took the dog for a walk thinking fresh air and movement would help. Walked about 2 blocks and felt as if I was going to collapse and could barely walk back. Made it back, my husband turned on the gas fireplace and held me really tight until it was over. Crazy experience!
58 2021-05-16 bell's palsy, numbness, facial paralysis Bell's Palsy, numbness and paralysis on right side of face, severe headaches
58 2021-05-16 pain in extremity, nerve pain Horrible nerve pain in left leg, buttock
58 2021-05-16 pain in extremity First shot arm/shoulder pain, fatigue.
58 2021-05-16 tremor jaw tremor
58 2021-05-17 feeling hot, burning sensation After the first injection I experienced hot redness around the bridge of my nose which I just though... Read more
After the first injection I experienced hot redness around the bridge of my nose which I just thought may be irritation from wearing procedure masks at work. After the second dose, the redness and heat spread to my cheeks and forehead (More dominant on the left side of forehead). this was accompanied by some swelling around the eyes and bridge of nose. It gets worse later in the day, around 3pm and feels like my head is burning. I also experienced gum pain on the bottom right. I did a course of Prednisone and a course of Penicillin- prescribed by my dentist. Neither changed it at all. I am now putting aloe on my face twice a day and have just begun a course of Chinese herbs. The aloe is soothing but not changing the redness. It is too soon to tell if the herbs are helping as I just began that course of treatment yesterday. I am also trying acupuncture to relieve the heat in my face but have just started that as well.
58 2021-05-17 tingling Note: the Lot # could be - ED7534 - difficult to say. I got the shot around 5 pm and felt fine until... Read more
Note: the Lot # could be - ED7534 - difficult to say. I got the shot around 5 pm and felt fine until about 01:00 AM. I started having chest pains in the muscle. I took 1/2 an alprazolam tablet but it didn't do anything. My chest felt tighter but I was still able to get a full breath through everything though. My throat got scratchy and tight. Both of my arms were feeling tingly. I have bone spurs, I associate tingling in the arm with bone spurs with my nerves and what they pressed. The vaccine seemed to make everything every chronic issue I have flare up. Around 2 am I took reg. strength Tylenol and the antihistamine because I take those twice a day regularly for year around allergies. I also took a Benadryl in case I was having an allergic reaction Around 2:30 am, my tongue started feeling kind of tingly especially on the right side. A lot of the chronic pain are worse on the right side of my body. I was feeling kind of nauseated. Around 3 am the tingly sensations spread up my face mostly on right side and I had pain in my teeth - not unusual because of the nerve damage that has happened on the right side. I had a hysterectomy some years ago and since then I've had cluster of nerves in my lower right abdomen that is the epi center of a lot of my nerve pain and that cluster started throbbing and sending it up into my chest and that started acting up and it runs up right to my left breast. This usually doesn't all happen to me at once but these are things that have happened to me before. I eventually went to sleep. NExt day, About 2:30 pm, I got out the pulse/ox thing - Oxygen: 97 - even though my heart was kind of pounding - my pulse was 65 and 60. I called my doctor's office and got transferred to COVID hotline at Hospital and I talked to nurse there who told me the vaccine can cause inflammation throughout the body which could cause the exacerbation of all my usual symptoms and why they all were flaring up all at once. All the doctors in my doctor's office were busy and she found a Physician's assistant who could talk to me and he told me what she had told me. And to be prepared for me to be prepared for it for the second dose. It took almost until it was time for my second dose of vaccination for the symptoms to dissipate. It was a very slow process. It was four days before I was going to get my second one before I felt like the symptoms had gone. I talked to my doctor before getting second one and she gave me the go ahead to get it.
58 2021-05-17 tingling stabbing pain going through body, ringing in ears, tingling in whole face, headaches, back of neck i... Read more
stabbing pain going through body, ringing in ears, tingling in whole face, headaches, back of neck is sensitive
58 2021-05-17 tingling 06:30pm I started to feel achy (flu-like achy); throat was sore and tight; nauseated. I got an incre... Read more
06:30pm I started to feel achy (flu-like achy); throat was sore and tight; nauseated. I got an increasingly bad headache. I had taken a couple of regular strength Tylenol - a little before 06:30 pm mostly to prevent soreness in my arm. Around 7:15 or 7:30, I felt this wave of fatigue wash over me and I was chilled and I crashed on the bed - blankets around me with hot water bottle. Fatigue and chills lifted around 11 pm; headache, aches and sore throat remained. Around midnight, in addition, my chest started to tighten up again although not as bad as the first time; tooth pain and jaw pain and tingling down both of my arms. It was worse on the right. About 1:30 am on the 9th, the tingling started moving up over my scalp and over my head. My heart was pounding again and it was like having an anxiety attack without the anxiety. I had pretty much all the same symptoms as I had the first vaccine but it wasn't as bad - it was a milder version of them. I couldn't fall asleep until 07:30 am and slept until 2:30 pm and the symptoms persisted. Later that day, on the ninth, my lungs were off gassing chemicals it seemed and I felt it is a mist was going off in my brain. Both of these things, I have experienced before and they seem to be kind of random and they don't really have a cause for them. Same thing for the symptoms continuing - note on April 23rd - diminishing slowly. Heart pounding continued - Pulsometer showed it around 70 or so but it felt it was really pounding. I had the nausea, headache, sore throat, achiness, blah feeling - flu-like symptoms again - these would pop up randomly for a few days and then go away. They were gone when I saw my doctor on the 3rd of May but they had not been gone long. (So between the 23rd of April and May 3rd they went away.) This does seem to have made my ME a little worse - I seem to be a little fatigued then I was before - everything else has gone.
58 2021-05-17 seizure I supposedly had a seizure/diagnosis was Convulsions; I began vomiting non-stop.; dry heaving; This ... Read more
I supposedly had a seizure/diagnosis was Convulsions; I began vomiting non-stop.; dry heaving; This is spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164) via an unspecified route of administration in left arm on 19Apr2021 12:15 as 1st single dose (at the age of 58-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history was not reported. The concomitant medication included escitalopram at a dose of 10 mg. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been diagnosed with COVID-19 since the vaccination. At about the 13 minute mark post-vaccination and while waiting in the facility, on 19Apr2021 at 00:30 (as reported) patient supposedly had a seizure. She was sitting and feeling fine and then came into the medical tent. The military medic/personnel insisted she had a seizure. After she came to, she began vomiting non-stop. They put her in an ambulance and she continued vomiting/dry heaving at that point on the way to the hospital and at the hospital. She was given anti-nausea medication in the ambulance and again in the emergency room. The diagnosis at (withheld) was convulsions, unspecified type. The adverse event resulted in a visit to Emergency room/department or urgent care. The treatment given for the adverse events included Lab tests, CT Head without Contrast, Zofran. The outcome of the events was recovered. Information on Lot/Batch number was available. Additional information has been requested.
58 2021-05-18 breast pain, numbness and pain in extremities Fatigue ,Neuropathy in feet and hands aggravated everything is on fire (much more pain). Breast impl... Read more
Fatigue ,Neuropathy in feet and hands aggravated everything is on fire (much more pain). Breast implants nerves on fire (Severe pain). Started 2-3 days after 2nd shot as of today still same pain
58 2021-05-18 night sweats, migraine After Second dose 4/10/21 on April 16 extreme fatigue extensive night sweats and nightly migraine ... Read more
After Second dose 4/10/21 on April 16 extreme fatigue extensive night sweats and nightly migraine Covid test on 4/19 was negative. Liver enzymes extremely elevated unable to obtain a platelet count with 5 attempts. Diagnosed with Mono on 4/23 without any exposure. I was diagnosed with covid on November 3 was very ill for 6 weeks. After second dose felt the exact same I felt with covid.
58 2021-05-18 pain in extremity Approximately 24 days after my second dose, I woke up feeling excruciating pain in my upper back, le... Read more
Approximately 24 days after my second dose, I woke up feeling excruciating pain in my upper back, left arm and hands. It was both throbbing consistently and/or piercing, stabbing pain at intervals. I took a nap and some ibuprofen PM so I can sleep and ignore the pain. Went to ER the following day as pain didn't subside and was increasing in pain. X-ray showed nothing was wrong. Was prescribed two pain meds. Cold and hot compress were not alleviating the pain. Lasted for a whole week. Then pain was intermittent and less painful but still continuously throbbing. None at the upper back but pain focused on left arm/hand. Advised by ER doctor to go to primary doctor if pain does not subside in two days and did so. No new diagnosis from ER: perhaps inched nerve. It is strange what is happening to me. Felt better after another week. Relief from some huge pain until pain returned a week ago, starting Friday, May 14th. It's been throbbing since and pain is intermittent. I am again drinking ibuprofen and naproxen as prescribed before to ease the pain and allow me to sleep and work.
58 2021-05-18 pain in extremity 45 minutes after getting the vaccine I couldn't stand. My right leg felt like it was being sawed off... Read more
45 minutes after getting the vaccine I couldn't stand. My right leg felt like it was being sawed off from my hip. The pain would change from my foot, hand, etc. It also caused me to be horribly inflamed. I was red and swelled for 2 weeks. For 3 days the pain was so bad, I wanted to go to urgent care. I am very scared about the second vaccine.
58 2021-05-19 bell's palsy Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 58-... Read more
Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533), via an unspecified route of administration in left arm, on 19Apr2021 at 03:30 PM (15:30), as second dose, single, for COVID-19 immunization. The patient's medical history herpes (for 31 years), possible exposure to HPV from 20 years ago (2001), and allergies to sulfa. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EP7534) on 29Mar2021 at 03:15 PM at the age of 58 years for COVID-19 immunization (left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01May2021 at 12:30 PM, the patient came down with Bell's palsy. The event resulted in doctor or other healthcare professional office or clinic visit. Treatment received for the adverse event included acyclovir and prednisone prescription. The patient considered the event as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.
58 2021-05-19 feeling hot my left hand and my foot swell; my left hand and my foot swell; my entire body hurts; I had the temp... Read more
my left hand and my foot swell; my left hand and my foot swell; my entire body hurts; I had the temperature almost like I got the flu; my head is really hurting; I feel disoriented; I am cold but like I am hot really hot. I felt like I am burning up; This is a spontaneous report from a contactable consumer or other non hcp. A 58-year-old female patient received BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0160; Expiration Date: 31Aug2021) as 2nd, single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus, ongoing thyroid disorder. The patient's concomitant medications were not reported. The patient stated "I take medicine for diabetes. I take thyroid medication. I have been taking the medication for the past, it's been some years now." The patient previously took BNT162B2, dose 1, on an unspecified date. On 07May2021 the patient experienced my left hand and my foot swell, my entire body hurts, i had the temperature almost like i got the flu, my head is really hurting, i feel disoriented, i am cold but like i am hot really hot. i felt like i am burning up. The patient stated that "I take Tylenol, I work for the government. A lot of medical workers do. A nurse said you take Tylenol . So, that's what I have been taking but it is not working." The outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.
58 2021-05-19 numbness, pain in extremity After 5 weeks, my arm is still numb and if I move it a certain way, it feels like a bee sting or ja... Read more
After 5 weeks, my arm is still numb and if I move it a certain way, it feels like a bee sting or jabbing a needle in my arm pain.
58 2021-05-19 numbness extremity numbness both hands and both feet went to doctor told to take motrin didn't help s... Read more
extremity numbness both hands and both feet went to doctor told to take motrin didn't help still have same numbness now 05/20/2021
58 2021-05-19 migraine Persistent headache, migraine status
58 2021-05-19 pain in extremity, burning sensation my left hand and my foot swell; my left hand and my foot swell; I had the temperature almost like I ... Read more
my left hand and my foot swell; my left hand and my foot swell; I had the temperature almost like I got the flu; my head is really hurting; Body hurting; I feel disoriented; it is not working; It started in the area where they shot me and then it became my entire arm and then my whole body just hurt though; I am cold but like I am hot really hot. I felt like I am burning up; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0160; Expiration Date: 31Aug2021) as second dose single for COVID-19 immunization. Historical Vaccine of BNT162B2 was received as a first dose on an unspecified date. Medical history included diabetes mellitus, infectious thyroiditis from an unknown date and unknown if ongoing. She stated, takes medicine for diabetes and thyroid medication. I have been taking the medication for the past, it's been some years now. Concomitant medications with paracetamol route of administration, start and stop date were not reported for an unspecified indication. The patient experienced my left hand and my foot swell (hand swelling and swelling of feet), had the temperature almost like she got the flu, my head is really hurting, body hurting, she felt disoriented, it is not working, it started in the area where they shot me and then it became my entire arm and then my whole body just hurt though, I am cold but like I am really hot. I felt like I am burning up on an unspecified date. Consumer stated, she took Tylenol, and she work for the government. A lot of medical workers do. A nurse said you take Tylenol. So, that's what I have been taking but it is not working. She stated, there was no need to have any treatment. I got the vaccine. I came home. I lay on the bed yesterday when I left there so, it was just started hurting. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
58 2021-05-19 pain in extremity, burning sensation pt states she got very nauseated immediately after taking the covid vax. She has had joint pain, vo... Read more
pt states she got very nauseated immediately after taking the covid vax. She has had joint pain, vomiting, fatigue, fever, and chills. She got a burning sensation in her eyes and poor vision. She had a tele-visit w/ her PCP about 7 days after getting vax. She was told to take Tylenol 500 up to 8000mg for the pain, but the amount of meds has hurt her stomach. She still had these symptoms and got the 2nd dose on 4/17/2021 in the right arm. Her symptoms got worse. She had to stop working due to the joint pain in her leg, arm, and shoulder. She feels like something is swollen on the right side of her body in her ear and her throat. She is having heart palpitations and breathing differently. She has had blood work and still waiting on the results. She had a negative Covid Test. She is still in alot of pain and she feels like it has changed her whole life. She is no longer a happy person as it has affected her mood.
58 2021-05-19 tingling, numbness numbness in left side; pins and needles in left hand and back of left shoulder; This is a spontaneou... Read more
numbness in left side; pins and needles in left hand and back of left shoulder; This is a spontaneous report from a contactable consumer (patient). A 59-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955; Expiration Date: 30Jun2021) via unspecified route single dose for COVID-19 immunization on 31Mar2021, at 58-year-old. The patient medical history was not reported. The patient's concomitant medications were not reported. In the last couple of days (Apr2021), she had been getting numbness in her left side. She reported this could be due to other medical issues. The patient described tingling that felt like pins and needles in her hand, only in her left hand, and a little bit in the back of her shoulder, behind edge of left shoulder. She ran her hand under warm water to try to make it go away. She explained it's almost as if she slept on her arm and it was asleep. Outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.
58 2021-05-20 tingling Patient received the 2nd COVID vaccine (Pfizer, lot #EW0182, use by 05/22/21 at 10:20am, expiration ... Read more
Patient received the 2nd COVID vaccine (Pfizer, lot #EW0182, use by 05/22/21 at 10:20am, expiration date 08/2021) at 1532. Client reported a tingling sensation in the L arm to employee at 1545. Employee immediately assessed client. The patient was A&O to person, time, place, and situation. No loss of consciousness or dizziness occurred. Vital signs were taken by EMT at 1545 with BP 155/45 in R arm sitting upright, HR of 78, RR of 18, and O2 saturation level of 100%. At 1550 the patient denied numbness, tingling, or shortness of breathe. Vital signs at 1550 were BP 155/75 in R arm sitting upright, HR of 75, RR of 16, and O2 saturation level of 100%. At 1600 patient was talking in full sentences and sitting upright in zero gravity chair. Client reported medical history of hypertension. Client is taking BP medication but was not able recall name of medication. Vitals at 1600 were BP 150/80 in R arm sitting upright, HR of 70, RR of 16, and O2 saturation level of 99%. At 1605, patient was stable and employee educated about V-Safe information and advised patient to follow up with her PCP at Hospital. Educated about ER precautions. Patient left the site at 1615.
58 2021-05-21 weakness Pfizer-BioNTech COVID-19 Vaccine EUA: patient seen for allergy clinic follow-up visit reporting thro... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient seen for allergy clinic follow-up visit reporting throat tingling within four minutes of vaccination. Three hours later experienced sensation of throat closing and left upper lip swelling. Patient went to emergency department (ED) where epinephrine and and steroids were administered. The patient was observed for three hours and discharged to home with a prescription for predisone. The next day patient reports facial erythema described as flat and non-pruritic that spread to the neck. The following day patient reports feeling feverish with elevated blood pressure, severe chills, chest pain, and trouble breathing. The patient returned to the ED, received diphenhydramine and steroids, was monitored and discharged to home. Patient received another prescription for prednisone from primary care provider. Patient reports intermittent low energy, chest pain, troubles breathing, and lip numbness since vaccination.
58 2021-05-21 bell's palsy Bell's palsy (left face); This is a spontaneous report from a contactable nurse (patient). A non-pre... Read more
Bell's palsy (left face); This is a spontaneous report from a contactable nurse (patient). A non-pregnant 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08Apr2021 (at the age of 58 years old) (Lot Number: ER8737, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient also received first dose of BNT162B2 in left arm on 18Mar2021 (at the age of 58 years old; Lot number: EP6955, unknown expiration) for COVID-19 immunization. The patient experienced Bell's palsy (left face) on 05May2021, 3 weeks following second dose. The patient confirmed that she never had it before. The patient received valacyclovir and prednisone as treatment for the event. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not yet recovered from the event. Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported Bell's palsy and the use of BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-05-21 burning sensation, numbness and pain in extremities 2-11-21 - 12:45 am called nurse line about severe headache and excessive pain following covid vaccin... Read more
2-11-21 - 12:45 am called nurse line about severe headache and excessive pain following covid vaccination (took place 2-10, 10:30am). By 5pm, right hand was experiencing extreme burning neuropathy, which then traveled down right leg into right foot, so arm, hand, leg, and foot were involved. No fever. By 8pm, body aches were really bad, and the beginning of a severe headache was showing. Temperature was 96.8. Headache continued to get worse - centered around area of previous head injury (1982) above and just behind left ear. Left ear was red and hot. Over time, pain radiated down back of head and down back of neck on left side. Also into left eye socket. Continued to increase area, involving jaw on left side and to lesser extent jaw on right side - both TMJs involved. Pain was 9 on pain scale. It hurt less to stand up - sitting and lying down made pain much greater. Because of fatigue and body pain, I had to stand and walk all night ? I was exhausted. 12:45am Called a nurse hot line. They told me I need to get to ER. I said I?m stuck ? I live on an island with no hospital and there?s no ferry at that time. Nurse said I needed to speak with an on call doctor as soon as possible. Began calling on-call doctor 1am. (It appeared to me that, where my new doctor practices, didn't have an on-call doctor.) said to call back in 10 minutes if I didn't get a call from the doctor. Called at 1:15am, then 1:30am, 2:00am, 2:30am, 2:45am. Still hadn?t gotten a call from the on-call doctor. Body temperature fell under 96. I used 2 different digital thermometers, and even tried a glass/mercury one, which when shaken all the way down, never moved (lowest register is 96). At the lowest, at 4:15am, my body temperature was 95 degrees. Finally around 4:30am, I took tramadol and wrapped my feet in a heating pad set on high. Was finally able to lie down, but extreme head and neck pain continued. On-call doctor finally called me just after 5am. By then, my temperature was at 96 again. He said the tramadol was a good idea, and said to take another. Told me to keep an eye on my temperature. Spent the next 2 days in bed. I could feel the incredibly strong body pain moving from place to place in my body, like someone walking on a path. For the next 2 weeks, I was fatigued and had brain fog. Because I heard that people had a stronger reaction to the second dose, I was apprehensive about it, considering how strong my reaction was to the first dose.
58 2021-05-21 pain in extremity I had no adverse effects at first, just a slight sore arm. A couple of days after receiving the sec... Read more
I had no adverse effects at first, just a slight sore arm. A couple of days after receiving the second dose, I started with heart palpitations, skipped beats, pounding and stopping at night when I laid down and after eating dinner. I have no history of any heart conditions, problems of any sort.
58 2021-05-21 pain in extremity After 4 days left upper arm started hurting and kept hurting worse. Went to clinic due to pain and r... Read more
After 4 days left upper arm started hurting and kept hurting worse. Went to clinic due to pain and received injection. Continues to hurt and returned to clinic and received medication for pain and muscle relaxer. Returned 5/22/21 due to continued pain and was sent to get ultrasound. To follow up with Orthropedic Doctor on May 24,2021.
58 2021-05-21 pain in extremity Systemic: Patient said she was experiencing left leg pain-Medium
58 2021-05-21 tingling, feeling hot, weakness severe allergic reaction; difficulty breathing; swelling of face and throat; swelling of face and th... Read more
severe allergic reaction; difficulty breathing; swelling of face and throat; swelling of face and throat; fast heartbeat; a bad rash all over the body; dizziness; weakness; pain at injection site on left arm/left arm started hurting; tingling hot pins all over; tingling hot pins all over; nausea; swelling on opposite shoulder on the right; back pain; chest pain; a cold sore on her lip; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that side effects began on 27Feb2021. Side effects included tingling hot pins all over, nausea, pain at injection site on left arm/ left arm started hurting, swelling on opposite shoulder on the right, back pain, chest pain and a cold sore on her lip. She went to the doctor a couple times and reported to her doctor that all her symptoms stopped on 04May2021. She was scheduled to go back to the doctor on 14Jun2021 and they are going to test her for antibodies. She would like to know since her side effects lingered for so long, if she should receive the second dose? She wants to receive the vaccine and be fully vaccinated but she doesn't want to go through this all over again. Everyone in her family was vaccinated and they did not have any side effects. Her doctor didn't want to tell her yes or no if she should receive the second dose. After reading the severe allergic reaction side effects that include difficulty breathing, swelling of face and throat, a fast heartbeat, a bad rash all over the body, dizziness and weakness, the patient stated that she has all of those side effects in the middle of the night and worse. Her doctor told her that a lot of stuff happened to her and it lingered for so long in a person that doesn't usually have reactions so she should hold off and mask up and social distance and come back for her appointment in June where she will be tested for antibodies. Her doctor did blood work and took pictures and made a report and told her to call and make a report as well. Outcome of the events was recovered on 04May2021. Follow-up attempts are needed. No further information is expected.
58 2021-05-22 weakness, pain in extremity, tremor After 6 hours my arm was painful despite keeping it moving. The next day I had additional symptoms. ... Read more
After 6 hours my arm was painful despite keeping it moving. The next day I had additional symptoms. At 2am I became aware of a slight headache. At 4am I woke up with chills and uncontrollable shaking. I put on a second set of pajamas and socks and was able to sleep 2 more hours. At 6.30am I felt very weak and nauseous. I felt aches and pain in my muscles and joints like having a cold/flu which lasted until all day and evening as did the feeling of nausea. I was fatigued all day and evening, falling asleep for 2 hours at 2.40pm and 7.11pm. I had to lay in a horizontal position most of the day to avoid vomiting. I ate very lightly and drank ginger ale and chamomile tea.
58 2021-05-23 weakness, tremor weakness, dizziness, winded after walking a short distance, tremors, tired.
58 2021-05-23 weakness aches, chills, weakness, chest pain, dizziness, diarrhea, vomiting, nausea, she was sent to ER after... Read more
aches, chills, weakness, chest pain, dizziness, diarrhea, vomiting, nausea, she was sent to ER after visiting a clinic
58 2021-05-23 breast pain Painful solid lumps developed in both breasts. I can not decide whether this has to be qualified as ... Read more
Painful solid lumps developed in both breasts. I can not decide whether this has to be qualified as permanent damage or none of the above in Item 21, but out of precaution I prefer to have it referred to as a permanent damage as we are trying to understand what's going on.
58 2021-05-23 flushing I work remotely and ate hazel nuts but I never had food allergies, but 10 minutes I started having s... Read more
I work remotely and ate hazel nuts but I never had food allergies, but 10 minutes I started having strange pain in upper back, my face felt flush and it was scarlet red, I got severe vertigo, and was disoriented. I took Benadryl and layed down, I took my BP and my systolic was down to 90. The doctor said it was an allergic reaction and it was serious enough that I thought I was having a heart attack. It all happened really rapidly. I went to see the allergist and was tested and it came back with nothing.
58 2021-05-23 pain in extremity, hot flush Extreme pain and swelling in armpit. Pain in groin, hip, leg (all on vaccine side). Hot flashes and ... Read more
Extreme pain and swelling in armpit. Pain in groin, hip, leg (all on vaccine side). Hot flashes and upset stomach.
58 2021-05-23 tingling, muscle spasms Syncope s/p vaccine #1, full body spasm, tingling>ED w/ pain meds/ IVF>dc'd home
58 2021-05-23 tingling Strange feeling to head. Tingling running down right arm and eventually down to feet. Tightness in... Read more
Strange feeling to head. Tingling running down right arm and eventually down to feet. Tightness in throat. Red chest and red face. Elevated blood pressure 170/100. elevated heart rate. Tingling in head in first 10 minutes. Began running down arm and then on into leg within 30 minutes. tightening in throat and dry cough within 15 minutes. Given 25 mg Benadryl within 10 minutes of onset of symptoms. Given sprite and peanut butter crackers which did nothing. Benadryl began to help. Given another 12.5 mg 15 minutes after initial dose. Pulse Oximeter good oxygen level 97-98 after benadryl. Ambulance was called and I refused. I was told to go to ER. My husband is a registered respiratory therapist and said he would watch me and not leave me alone. He said he would take me if symptoms got worse. Called my dr. Was told to take Benadryl around the clock for 48 hours.
58 2021-05-24 pain in extremity Patient received vaccine in left deltoid on 5/12/21. On 5/14/21 started to have left upper arm swe... Read more
Patient received vaccine in left deltoid on 5/12/21. On 5/14/21 started to have left upper arm swelling, pain, warmth. Had doppler done on 5/18/21that showed left brachial vein DVT. Started on Eliquis immediately At followup on 5/25/21, swelling reduced, pain and warmth resolved.
58 2021-05-24 tingling After the second injection on April 16th, 2021 at hospital (vaccine site), about 3-4 hours later sta... Read more
After the second injection on April 16th, 2021 at hospital (vaccine site), about 3-4 hours later started with symptoms. Initially started with headache, fatigue. Then changed to vestibular. Such as left ear pressure, dizziness, nausea at times, (vestibular). The symptoms have NOT stopped and increasing! Huge medical workup. Also had new cardiac symptom (possible short run of svt) went to ER, overnight, 2 week home monitor which is now completed. But the vestibular symptoms are increasing, including bilateral facial paresthesias, now moving into my hands at times. Balance at times affected now and more. I walked in ok and now a medical nightmare.
58 2021-05-25 inability to speak 2nd dose received. AFter a few minutes, patietn reporting "fuzzy lip" sensation. No swelling, angioe... Read more
2nd dose received. AFter a few minutes, patietn reporting "fuzzy lip" sensation. No swelling, angioedema, chest pain, shortness of breath, tongue swelling, airway obstruction or difficulty speaking or diaphoresis. No issues with 1st dose. Monitored for 30 minutes. Symptoms improved/resolved and patient was discharged from clinic.
58 2021-05-25 feeling hot, migraine, pain in extremity My arm was hot and shooting pain in left arm, My migrames got more intense, I went into sneezing sp... Read more
My arm was hot and shooting pain in left arm, My migrames got more intense, I went into sneezing spells for a half a hour. I felt hot and my stomach was upset for several days. My head felt light headed and my eyes were blurrey. I recieved the Pfizer vaccine.
58 2021-05-25 pain in extremity Left arm soreness up through left side of neck three weeks after injection,; headache from injection... Read more
Left arm soreness up through left side of neck three weeks after injection,; headache from injection through this report (3 weeks post-injection); Left arm soreness up through left side of neck; This is a spontaneous report from a contactable patient. A 58-year-old adult non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH, Batch number was EL3247) via an unspecified route of administration on the left arm on 23Feb2021 at 11:00 AM (at the age of 58-years-old) for COVID-19 immunisation. Her medical history included allergic to penicillin, erythromycin, metronidazole (FLAGYL). Concomitant medications given within 2 weeks of vaccination included (levothyroxine) SYNTHROID, liothyronine (CYTOMEL), escitalopram (LEXAPRO), all administered for an unspecified indication however no any other vaccines were provided within 4 weeks prior to the COVID vaccine. Furthermore, prior to vaccination, she was diagnosed with COVID-19 and since the vaccination, she has not tested positive for COVID-19. On an unknown date in Mar2021 (3 weeks post vaccination), she experienced left arm soreness which then radiated to left side of neck three weeks after injection, headache from injection reported. Sumatriptan (IMITREX) was taken by the patient to treat these events and she visited doctor office due to these events as well. At the time of report, the clinical outcome of left arm soreness up through left side of neck and headache was not recovered. No follow-up attempts are possible. No further information is expected.
58 2021-05-26 bell's palsy Bells Palsy; This is a spontaneous report from a contactable consumer. This consumer (patient) repor... Read more
Bells Palsy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 58-year-old female patient received second dose of bnt162b2 (BNT162B2, Pfizer COVID 19), via an unspecified route of administration, administered in Arm Right on 27Mar2021 10:00AM (Batch/Lot Number: EM6208) as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, lot number: EN6203) on 06Mar2021,10:00 AM in Right arm for covid-19 immunisation. The patient experienced bells palsy (medically significant) on 12Apr2021 23:00 with outcome of recovering. Therapeutic measures were taken as a result of bells palsy included Steroids and antibiotic. The clinical course was reported as follows: Im not sure it was the shot. But they said to report it. After 2 weeks and 1 day I came down with Bells Palsy.Ae resulted in [Emergency room/department or urgent care]. No covid prior vaccination. No covid tested post vaccination. No known allergies. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested
58 2021-05-26 numbness pt stated arm was feeling numb. pt refused medical attention. was given Benadryl once 25mg tab. pt w... Read more
pt stated arm was feeling numb. pt refused medical attention. was given Benadryl once 25mg tab. pt wait and monitored for 30 minutes and was ok upon leaving. pt was not in respiratory distress.
58 2021-05-26 muscle spasms, tremor, weakness Developed high fever night of obtaining 2nd vaccine that got as high as 103. Swollen lymph nodes and... Read more
Developed high fever night of obtaining 2nd vaccine that got as high as 103. Swollen lymph nodes and glands lasted for 2 days. Three days later, tremors feeling possible seizure but did not have one. Additionally stated to have muscle spasms, weakness and muscle contractures mainly right side extremities and lower back and pelvis area started. The muscle spasms have continued to occur just not every day any more. I had muscle spasms in my leg last night so would not say all symptoms have resolved yet.
58 2021-05-26 pain in extremity, muscle spasms shingles; couldn't sleep; limping; arthritis is acting up/ throbbing, aching, tightening, and painfu... Read more
shingles; couldn't sleep; limping; arthritis is acting up/ throbbing, aching, tightening, and painful; pain is in one leg in the thigh; leg was swollen and painful and spread up to her hip; muscle spasms in her legs; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 28Apr2021 09:00 am (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included ongoing diabetes had for about 6-7 years, ongoing arthritis patient has had for years, started when she was little; family medical history included her dad had rheumatic fever and high blood pressure. Concomitant medication(s) included ongoing metformin taken for diabetes. Patient was borderline due being overweight, if she lost weight it would probably go away. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No additional Vaccines Administered on Same Date of the Pfizer Suspect other than the first dose. Prior Vaccinations (within 4 weeks) was none. Patient received first shot on 02Apr2021 8:40 am (Lot: EP7334) in left arm for covid-19 immunisation. It was noted that with the first shot, there was pain and it turned red at the injection site that last 6 days and then that went away. She took Tylenol and hot water in the shower to treat this event. Caller reported that the first dose just swelled her arm. Expiry and NDC are unknown for both shots. The patient experienced arthritis is acting up/ throbbing, aching, tightening, and painful; pain is in one leg in the thigh; leg was swollen and painful and spread up to her hip and muscle spasms in her legs on 29Apr2021, shingles, couldn't sleep and limping on an unspecified date. Caller stated that she had both doses of the vaccine. Agent called back to verify that the doses were the Pfizer covid 19 vaccine and the date of the second dose. Caller stated that her second dose of the Pfizer covid 19 vaccine was on 28Apr2021. Caller reported that after the second dose she was diagnosed with muscle spasms in her legs by one doctor and the ER doctor told her that her arthritis is acting up. Caller stated it felt like she got the second shot in her leg. Caller reported that the pain is in one leg in the thigh on the side that she got the shot on. Caller stated her doctor wants her to go to a neurologist thinking it could be shingles. Caller stated the doctor called a medication in for her for shingles. Caller stated she was using the heating pad and taking flexeril and neurontin. Caller stated she has not gotten any sleep. Caller stated she missed work yesterday and today. Caller stated she has pain in her legs and wanted to know how long that will last. Caller, reporting on the Pfizer COVID shot, and who explained that after getting the shot her leg started acting up the next morning. She explained that it has been throbbing, aching, tightening, and painful. She went to the emergency room and they told her they think is it is her arthritis; that the shot irritated and made it worse. She was given a shot, they thought maybe it startd with a T or like Tylenol, but it was something for pain. They wanted to give pain medication to take with her but she refused; told them she would just do Aleve and Tylenol. She still got no relief so she went to her medical doctor and they told her it was muscle spasms, the nurse said she could feel a knot. They treated it and that didn't help. Finally her doctor gave her Neurontin yesterday. She has been taking that since 12 noon yesterday through today and she will say it is getting better explaining that she hasn't able sleep but now can get cat naps. Caller reported she is a caretaker, like a medical assistant. She had been missing days from work because of this. The doctor was going to try and find her a specialist, a neurologist. When asked Primary / Prescribing Healthcare caller stated she saw in the emergency room and as a medical doctor because her normal primary care doctor retired. She didn't have contact details for either of these doctors. The shot was given by some people. It was clarified that this was after the second shot. The second shot was on 28Apr2021. She explained she was limping cause it hurts so bad, ever since she got the second shot. Neurontin was started yesterday and since starting it she is better, she was able to sleep some where she couldn't sleep before. Caller reports the product is in a pharmacy bottle with the NDC: 65862-0523-05. Name and NDC captured as provided by the caller. When asked about the products taken that didn't offer relief, everything prior to the Neurontin the caller only had the Flexeril bottle handy. She didn't have the name of the medication, the shot given in the emergency room and didn't want and pain medication from there because she didn't want to get hooked on pain pills. She also took Aleve and Tylenol. Gave her Flexeril, on 06May2021 it was filled. It is in a pharmacy bottle, no manufacturer, Lot or Expiry, NDC: 48547-0400. There are little number and hard to read but confirmed it is in pharmacy bottle. Treatment: she did have blood work but was told her cholesterol and everything was fine, everything was good. AE(s) required a visit to emergency room on 02May2021. And resulted in physician office, doctor on 10May2021. AE(s) following prior vaccinations was none. Caller received her second dose of the covid-19 vaccine and the next day woke up and her leg was swollen and painful and spread up to her hip. Caller went to the emergency room and was given medication which she states helps a little. Investigation included blood test with unknown result on unspecified date. The event outcome for all events was unknown.
58 2021-05-26 pain in extremity pain under armpit, swollen
58 2021-05-26 pain in extremity My arm has hurt starting two days after the 1st vaccine shot and continues to hurt today, May 27, 20... Read more
My arm has hurt starting two days after the 1st vaccine shot and continues to hurt today, May 27, 2021. I cannot sleep on my right side because of the pain. At times it hurts too much to lift the arm.
58 2021-05-26 pain in extremity Soreness at injection, down the arm to hand; Soreness at injection, down the arm to hand; minor head... Read more
Soreness at injection, down the arm to hand; Soreness at injection, down the arm to hand; minor headache; chills; tired; This is a spontaneous report from a contactable reporter, patient. A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via unspecified route of administration in the right arm on 15Mar2021at 10:45 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via unspecified route of administration in the left arm on 22Feb2021 at 10:45 (at the age of 58-years-old), as a single dose for Covid-19 immunisation. The patient Medical history was not reported. Concomitant medication included ibuprofen and claritin from for unknown indication an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19 and the Patient has not tested positive for COVID-19, since having the vaccine. The facility where the most recent COVID-19 vaccine administered was at a Workplace clinic. The patient experienced soreness at injection, down the arm to hand, minor headache, some chills, tired and arm soreness on 15Mar2021 at 11:00. No treatment was receive for reported events. The clinical outcome of the vaccination site pain, tired, headache, pain in arm, chills was recovering. No follow-up attempts are needed. No further information is expected
58 2021-05-27 weakness nausea started at 1pm day of vaccine and lasted 72 hours, DIARRHEA (severe) started at 2pm day o... Read more
nausea started at 1pm day of vaccine and lasted 72 hours, DIARRHEA (severe) started at 2pm day of vaccine and lasted 48 hours, VOMITING (severe) started at 4pm day of vaccine and lasted 13 hours, The following symptoms started at 3pm day of vaccine and continued for 72 hours aches and pain entire body, muscle and joint pain, chills, dizziness, weakness, headache, pain at injection site.
58 2021-05-27 weakness Aprox. 15 hours post vaccine: chills-lasted 4 hours, fever ranging 99-100.2 - lasted 15 hours, body... Read more
Aprox. 15 hours post vaccine: chills-lasted 4 hours, fever ranging 99-100.2 - lasted 15 hours, body aches and headache- lasted 18 hours, very tired and weak -lasted 24 hours, nasal congestion -lasted 24 hours, rapid heart rate-lasted 24+ hours, lymph nodes under arms tender -lasted 18 hours. Took combination of Tylenol and Advil to control symptoms.
58 2021-05-27 bell's palsy, speech disorder I can't eat; can talk now unlike before; Vomiting; Nauseated; I had a Bell's palsy after the vaccine... Read more
I can't eat; can talk now unlike before; Vomiting; Nauseated; I had a Bell's palsy after the vaccine; temperature happened; body ache; My lymph nodes are swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (Pfizer COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in left arm on 08Jan2021 (Lot Number: EL1283) as single dose for COVID-19 immunization. Medical history included hypertension, asthma and gallstones from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously received 1st dose of bnt162b2 (Pfizer COVID-19 vaccine), via an unspecified route of administration, administered in left arm on 21Dec2020 (Lot Number: EH9899) as single dose for COVID-19 immunization. Second dose was on 08Jan2021 and then after that, the patient had those like lower mouth pain, experienced a headache and the temperature and the body ache and everything all happened. Lymph nodes are swollen already and so patient went to doctor and they gave Augmentin (treatment) on 17Jan2021. The patient saw how her face was looking, she had a Bell's palsy after the vaccine. She didn't worked since January until the time of report because of so many tests that she did and have spent a lot of money already. She was depressed for how many months and can't eat and face has droop and eyes was hurting a lot, it is kind of emotional thing and spending a lot of money already on tests and everything. Still experiencing Bell's palsy, still have some droop in face but can talk now unlike before but every time she talks there is saliva coming out in left face. For the treatment of events: they gave Augmentin, that is the antibiotic, the tablet, 3 times a day. The other one is Valtrex, 1 gram, three times a day also. There is another one, it is Medrol, one tablet three times a day. Also, as patient was having the headache that time, taking (not clear) two tablets every six hours. Anti-nausea over the counter medicine as needed because of vomiting and nauseated always that time. The Medrol they gave twice on that time after she finish the first Medrol, they gave her Prednisone three times a day also. Outcome of event Bell's palsy was not recovered, for event can talk now unlike before was recovering, for the other events was unknown.
58 2021-05-27 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Pain at injection site (left arm) within 1 hour of being bitten... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Pain at injection site (left arm) within 1 hour of being bitten twice on left hand by unknown insect(s) while gardening. Bites were raised, red, extremely itchy, with allergic ring around them. Left arm pain was intense x 18 hours then just painful to touch.
58 2021-05-27 cold extremities, pain in extremity Severe vomiting; Severe diarrhea; fever; pain in left ankle and foot; extreme cold hands and feet, f... Read more
Severe vomiting; Severe diarrhea; fever; pain in left ankle and foot; extreme cold hands and feet, fever on and off,; pain in left ankle and foot; extreme abdominal pain; dehydrated; lip started swelling; This is a spontaneous report from a contactable consumer. A non-pregnant 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06May2021 14:45 (Batch/Lot Number: EW0172) as 2nd dose, single (at the age of 58 years old) for COVID-19 immunisation. Medical history included high heart rate, bp and prediabetic. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]), hydrochlorothiazide, triamterene (MAXZIDE) and duloxetine hydrochloride (CYMBALTA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took VALIUM and experienced allergies; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1, (lot number: EW0158) 14Apr2021 at 10:15 AM on left arm for COVID-19 immunisation and experienced lip swelling, bnt162b2 for covid-19 immunisation and experienced lower lip and chin swelling, Itchy chest, bumps, unable to walk and left knee severe joint pain. The patient experienced 15 minutes after shot, lip started swelling on 06May2021 15:00. Severe vomiting, severe diarrhea, fever, extreme abdominal pain, extreme cold hands and feet, fever on and off, pain in left ankle and foot on 07May2021 12:30. The patient went to emergency room (er) 3 days after vaccine (dehydrated, extreme abdominal pain) 6 days later still have abdominal pain, diarrhea, vomiting and fever. The patient received IV(intravenous fluids), potassium, abdominal CAT (computerized tomography) scan, Troponi (unknown drug). Prior to vaccination, was the patient not diagnosed with COVID-19 and been tested for COVID-19 (nasal swab) on 09May2021 and the result was negative. The outcome of the events were not recovered.
58 2021-05-28 numbness, burning sensation, tingling numbness in legs in legs arms hands back face; Burning in legs arms hands back face; tingling in leg... Read more
numbness in legs in legs arms hands back face; Burning in legs arms hands back face; tingling in legs arms hands back face; This is a spontaneous report from a contactable Consumer (patient). A 58-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), via an unspecified route of administration, in Left Arm on 02Feb2021 at 16:00 (at 58 years) at single dose for covid-19 immunisation . Medical history included allergy to Salmon and react to codeine. Concomitant medication included ibuprophen and vitamins. Previously on 31Jan2021 at 09:00 (at 58 years) patient took the first dose of the vaccine (lot EL0142) in Right arm for covid-19 immunisation. On 25Feb2021 at 08:00 the patient experienced "burning tingling numbness in legs arms hands back face". No treatment given. The outcome of the events was unknown.No follow-up attempts are possible. No further information is expected.
58 2021-05-28 numbness Toes turned purple; Large purple circle on my arm below the injection site; numbness in my lower lef... Read more
Toes turned purple; Large purple circle on my arm below the injection site; numbness in my lower left lip which spread to my chin and lower cheek the following day.; numbness in my lower left lip which spread to my chin and lower cheek; This is a spontaneous report from a contactable patient. A 58-year-old non-pregnant female patient received second single dose (Pfizer -BioNTech Covid-19 mRNA Vaccine,) via an unspecified route of administration on the right arm on 24Feb2021 for COVID-19 immunisation. Her medical history included hypothyroidism. She has no allergies to medications, food, or other products. Prior to vaccination, she was not diagnosed with COVID- 19 and has not tested for COVID-19, since the vaccination. Furthermore, she has not received other vaccines within 4 weeks prior to the COVID vaccine. She received concomitant medications within 2 weeks of vaccination were multivitamin, atorvastatin (LIPITOR 20mg) and levothyroxine (SYNTHROID 112 mg). Her past vaccination history included (Pfizer -BioNTech Covid-19 mRNA Vaccine) first single dose via unspecified route administered on right arm on 04Feb2021 for COVID-19 immunisation. On 24Feb2021 (the same day of vaccination), she had large purple circle on her arm below the injection site. On 25Feb2021, the patient toes turned purple but cleared quickly. On an unreported date (9 days post vaccination on an unknown date in 2021), she experienced some numbness in her lower left lip which spread to chin and lower cheek the following day. She felt better after a couple of days but still felt a slight numbness in her lower lip. It was reported that she did not receive any treatment for the events. At the time of the report, she has recovered from toes turned purple and was recovering from numbness in face and lips however the clinical outcome of large purple circle on my arm below the injection site was unknown. No follow-up attempts are needed. No further information is expected.
58 2021-05-28 pain in extremity Pfizer=BioNTech COVID-19 Vaccination. about 25 minutes post shot thru 45 minutes post shot, very red... Read more
Pfizer=BioNTech COVID-19 Vaccination. about 25 minutes post shot thru 45 minutes post shot, very red slightly swollen face, pinching paind in left wrist/hand. Then on 4/20 thru 5/21m extremely achey thru upper back down both arms thru hands, more on left side. Diarrhea on morning of 5/29. No fever or chills as of 5/29
58 2021-05-29 numbness Patient tongue and cheek were numb. patient felt it was a mild allergic reaction. Patient was given ... Read more
Patient tongue and cheek were numb. patient felt it was a mild allergic reaction. Patient was given OTC benadryl to take for the evening, and told if problem breathing should contact physician
58 2021-05-30 pain in extremity, facial pain, tingling R arm pain, R sided facial pain, after second shot, R sided leg pain/parasthesia. Unable to walk.
58 2021-05-30 pain in extremity Arm was AS sore this time. But several hours after receiving it, I started getting a headache,Took T... Read more
Arm was AS sore this time. But several hours after receiving it, I started getting a headache,Took Tylenol and went to bed. Woke up a couple of hours later VERY FATIGUED AND ACHY, FEVER OF 100.8, HEADACHE. All of this lasted about 18 to 20 hours. Approximately 24 hours after vaccination, I started feeling nauseous and light headed, which lasted an additional 24 hours. DID NOT seek or need medical care. Tylenol helped, except for the nausea
58 2021-05-31 burning sensation, pain in extremity, tingling, numbness Numbness, burning, tingling like when your body part falls asleep. Most often at night and is in bo... Read more
Numbness, burning, tingling like when your body part falls asleep. Most often at night and is in both hands bilaterally, but primarily in my fingertips. Especially, my r. thumb. This is painful and happens every night where I wake up and have to sit up or stand to drain the blood back to my extremity to decrease the burning sensation and even then I'm now finding it doesn't always help. I have noticed this is happening during the day to my right hand more often and I'm dropping objects picked up with my r. hand. I have an appt to visit my doctor regarding this because it has become so bothersome and is new onset since vaccination.
58 2021-05-31 numbness 58 y/o female with past medical history of Hypertension who presents with left arm numbness post vac... Read more
58 y/o female with past medical history of Hypertension who presents with left arm numbness post vaccination. Patient states that this is her first vaccination in the two-dose series. Patient denies previous reactions to vaccinations in the past. Patient states that she received the vaccination to the Left arm. Patient states that her left arm feels numbness or like it has fallen asleep. NP and Paramedics at patient side. Patient with equal pulses to bilateral upper extremities, cap refill less than 3 seconds, patient with FROM of the left upper extremity. Patient denies sore throat, difficulty swallowing, difficulty breathing and/or chest pain. Instructed patient to move/exercise the left upper extremity. Patient with Hypertension on initial vitals, 173/104 BP, 98% RA, 78 HR, 12 Resp, EKG NSR. Patient states that she took both of her blood pressure medications this am (Losartan and Hydrochlorothiazide). Within 30 mins patient with resolution of left arm numbness but hypertension remained. BP taken siting, lying, standing with no improvement. Patient BP increased to 182/107 and Rescue notified. Fire rescue was delayed in arriving. Patient was monitored by NP and Paramedics for over an hour. Once rescue arrived patient BP normalized to 150/99. Patient refused transport to ER. Patient signed AMA with rescue and patient was provided with the AMA form, patient signed and ambulated off site without difficulty.
58 2021-05-31 muscle spasms Pt c/o dizziness, fatigue w/wheezing on UL lungs and leg cramps. VS taken BP 133-163/78-87; HR 63-71... Read more
Pt c/o dizziness, fatigue w/wheezing on UL lungs and leg cramps. VS taken BP 133-163/78-87; HR 63-71. O2 sat 93-99% on RA. Provided pt w/water. Pt currently visiting from another country w/language barrier. Here w/son. Advised by PA to go to ED for evaluation but pt/family refused to go w/ambulance. Signed AMA form. Pt left clinic in stable condition & ambulating w/stable gait.
58 2021-05-31 muscle spasms Cramping and bleeding on 5/5/2021 and 5/24/2021 in post-menopausal woman.
58 2021-05-31 pain in extremity Right arm pain into shoulder, neck and ehind righ ear
58 2021-06-01 numbness, pain in extremity, weakness Fever and general weakness for two days which resolved. Burning pain in left calf muscle and decrea... Read more
Fever and general weakness for two days which resolved. Burning pain in left calf muscle and decreased sensation in left foot, decreased sensation in left arm and left part of face. I can still feel but it is not the same as the other side. I am still having decreased sensation as I write this.
58 2021-06-01 migraine metallic taste in my mouth, chest pain, nausea, throat closed up. went to the ER via ambulance. migr... Read more
metallic taste in my mouth, chest pain, nausea, throat closed up. went to the ER via ambulance. migraines, brain fog , fatigue
58 2021-06-01 tingling Severe swelling and armpit pain on injection side; Severe swelling and armpit pain on injection side... Read more
Severe swelling and armpit pain on injection side; Severe swelling and armpit pain on injection side; severe hip pain; overall pain and tingling in left side; overall pain and tingling in left side; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 05Apr2021 at 16:45 (at the age of 58-years-old) as 2nd dose, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included rosuvastatin (ROSUVASTATIN), vitamin c [ascorbic acid] (VITAMIN C) and vitamin d [vitamin d nos] (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient previously took bactrim and experienced drug hypersensitivity. The patient previously received first dose of BNT162B2 (Lot number was unknown), via an unspecified route of administration in arm left on 05Apr2021 at 16:45 for covid-19 immunization. On 29Apr2021 at 15:45, the patient experienced severe swelling and armpit pain on injection side, severe hip pain on injection side, overall pain and tingling in left side. The reporter classified the events as non-serious and stated the events result doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
58 2021-06-02 facial paralysis, pain in extremity, numbness stroke like symptoms/minor stroke; high/extremely high blood pressure; blood sugar numbers were very... Read more
stroke like symptoms/minor stroke; high/extremely high blood pressure; blood sugar numbers were very high in the 700s; face on the left side felt paralyzed like she couldn't feel if something was in her mouth; trouble seeing on the side of her eye/can only see straight on the left side; Blurry vision; fall; splintered hand; losing her balance; numbness in her arm; Soreness/sharp pain on her arm; dizzy spells; fatigue; This is a spontaneous report from a contactable consumer (daughter). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 17Mar2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke in 2012 (first stroke was from a heart attack), heart attack in 2012, stroke in 2017, stroke in Dec2020, high blood pressure from 2012 and ongoing, diabetes from 2013 and ongoing, glaucoma from 2009 and ongoing, ongoing at risk for heart failure, ongoing tumor in her stomach (23 years, benign and hasn't been surgically removed due to other issues and not harming her), ulcers (3 ulcers in the past and none currently), broken ankle in 2014, preeclampsia attack in 1990, baby being strangled during birth in 1994, broke her pelvis during birth in 1996, and complicated birth in 1996 (which she was in a coma for). The patient had no family history. Concomitant medications included labetalol (MANUFACTURER UNKNOWN) taken for heart condition from Dec2020 and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for stroke from 2012 and ongoing; furosemide (MANUFACTURER UNKNOWN) from an unspecified date and ongoing; atorvastatin (MANUFACTURER UNKNOWN) taken for stroke from an unspecified date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nicotinic acid, pantothenic acid, phosphorus, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, vitamin B12, vitamin D, vitamin E, vitamin K, zinc (CENTRUM WOMEN 50+) from an unspecified date and ongoing, and unspecified eye drops for glaucoma from an unspecified date and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced stroke like symptoms/minor stroke, high/extremely high blood pressure, blood sugar numbers were very high in the 700s, face on the left side felt paralyzed like she couldn't feel if something was in her mouth, trouble seeing on the side of her eye/can only see straight on the left side, and blurry vision on 08Apr2021, which all required hospitalization from Apr2021 to Apr2021 for 4 days. The patient also experienced losing her balance, numbness in her arm, soreness/sharp pain on her arm, dizzy spells, and fatigue on 08Apr2021 and fall and splintered hand on 30Apr2021. The clinical course was reported as follows: It was reported that the patient had stroke like symptoms, which were reported to be not a result of the vaccine as the patient had a lot of health issues. The patient had the vaccine and was completely fine and then right around the time she was supposed to get her second dose she was showing signs that could have been a minor stroke. She just had high blood pressure and her blood sugar numbers were very high in the 700s on 08Apr2021. It affected her face. It was not a full on stroke, she got to the hospital in time. The patient had strokes before. They thought it was better to stabilize her blood pressure and blood sugar before getting the next shot. She was in the hospital for 4 days. They gave it time to stabilize and come to a normal number. When it did and they went back to the pharmacy, they said they did not feel comfortable administering the second shot after 42 days. Now it was pushing more than 42 days. The reporter stated she would not necessarily call it a stroke. Her mother had symptoms leading up to a stroke but not a full on stroke. She had numbness of her arm and blurry vision, but not a full on stroke. She was in the hospital the week of 07Apr2021. She was supposed to have the second shot on 14Apr2021. She was discharged from the hospital the week of 12Apr2021, either that Monday or Tuesday. She had trouble seeing on the side of her eye. She can only see straight on the left side. Her face on the left side felt paralyzed, like she couldn't feel if something was in her mouth. She has been losing her balance. Her blood pressure was through the roof on 08Apr2021, as well as her blood sugar. She did a video chat with the doctor the night before going to the emergency room (ER). They monitored her symptoms, and they started within the first 72 hours before going to the hospital. She had a blind spot in her left eye. The other one she can see just not as great as before. Before this instance she did not have a blind spot, and now she does. The patient walked with a cane now. If she is outside, she is held with someone and cannot just walk along because she does not see well by herself. She had to sit at a certain angle to see clearly. Her vision is not well. The numbness in her arm comes and goes. Sometimes it is a sharp pain and sometimes it is numb. It was definitely worse when she was at the hospital. The numbness and sharpness level goes hand in hand with when her blood pressure is too high and fluctuates with her blood sugar and blood pressure. With her face feeling paralyzed, her left eye socket is closed a little bit. She has more mobility than when it happened. She has been working on it with physical therapy trying to get it back. Her balance was off when she wasn't seeing well and was unassisted. She would get dizzy spells and fall. Now she is more aware of when she will feel dizzy and will let them know. The cane helps her balance. The dizzy spells came at the same time as the other symptoms. They fluctuate. They have stabilized over time. When it first happened, they were a lot more frequent. Now they almost never happen. The patient underwent lab tests and procedures, all in 2021, which included bloodwork: unknown results, computerised tomogram (CAT) scan: unknown results, and x-ray: unknown results (on her hand when she broke it in the past 2 weeks). The clinical outcome of stroke like symptoms/minor stroke, soreness/sharp pain on her arm, fatigue, fall, and splintered hand was unknown; high/extremely high blood pressure, blood sugar numbers were very high in the 700s, face on the left side felt paralyzed like she couldn't feel if something was in her mouth, losing her balance, numbness in her arm, and dizzy spells was recovering; and trouble seeing on the side of her eye/can only see straight on the left side and blurry vision was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
58 2021-06-02 numbness Right side of face went completely numb as if i haded received a novacaine shot; This is a spontaneo... Read more
Right side of face went completely numb as if i haded received a novacaine shot; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6204) via an unspecified route of administration, administered in right arm, on 05Mar2021 at 08:45 (at the age of 58 years old) as 1st dose, single, for COVID-19 immunisation. The patient's medical history included migraine and known allergies to sulpha medications. Concomitant medications included bupropion; and, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); both were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021, it was reported that the patient's right side of face went completely numb as if she had received a novacaine shot. The patient received stroke protocol and testing as the treatment. The patient has not been tested for COVID-19 since the vaccination and it was unknown if she was diagnosed with COVID-19 prior to vaccination. The outcome of the event was recovering. Information on Lot/Batch number was available. Additional information has been requested.
58 2021-06-03 feeling hot, tingling, numbness, pain in extremity, muscle twitching Sensation that moved up my jaw to my neck and then to my brain and head then jaw and neck pain ting... Read more
Sensation that moved up my jaw to my neck and then to my brain and head then jaw and neck pain tingling in my whole head and brain with pressure. Blurred vision the the next morning have facial numbness. Dizziness vertigo leg tingling. And pain. While Arm pain in injection side. Pain in side of body with injection Muscle twitching in injection arm throat tightness and swelling me coughing Sinus pain and headache tiredness feeling unwell. Felling hot all over
58 2021-06-03 nerve pain The 3rd day after my 2nd Pfizer shot, I got sharp dental nerve pain in several teeth on the right si... Read more
The 3rd day after my 2nd Pfizer shot, I got sharp dental nerve pain in several teeth on the right side to the midline. Since it is only on one side, it does not seem to be teeth grinding at night. Since it is both upper & lower jaws, it does not seem to be related to seasonal allergies/sinuses. (upper jaw) The pain intensity varies day-to-day and tooth-to-tooth. Pain occurs without eating/chewing. Upper right - teeth #5,4,3 and roof of the mouth near those teeth. Sometime between teeth #8 & 9. Lower right - teeth #29 & 30, with pain under the right jaw near those teeth. Sometimes between #25 & 24. There is also new dental sensitivity to chewing and food temperatures on the right side. I have been treating the sharp dental nerve pain with OTC aspirin and Aleve every day. Today (6/4/21) is the the first morning when the pain is dull enough that I have not taken an OTC pain medication ... yet.
58 2021-06-03 pain in extremity Shingles; soreness in my left arm/I woke with severe pain in that arm; This is a spontaneous report ... Read more
Shingles; soreness in my left arm/I woke with severe pain in that arm; This is a spontaneous report received from a contactable consumer (Patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0165 and expiry date was not reported), dose 1 via an unspecified route of administration, administered in arm left on 03May2021 single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included COVID-19, prior to vaccination on unspecified date, start and stop date were not reported. Since the vaccination, patient has not been tested for COVID-19. The patient had no relevant medical history and concurrent conditions and no past drug event. Concomitant medication(s) included ergocalciferol (VIT D) and folic acid taken for an unspecified indication, start and stop date were not reported. Patient did not feel anything for 2 weeks post vaccination but on 18May2021 in the evening, patient felt soreness in her left arm. By 1:30 AM, patient woke with severe pain in that arm. patient tried to treat it with Ibuprofen, but nothing happened. The pain continued throughout the next day and she tried to treat it with Norco (hydrocodone), but nothing was relieved. The next day on 20May2021, patient was diagnosed by my doctor with Zoster (Shingles). The outcome of the events was recovering. Follow up needed, further information has been requested.
58 2021-06-03 pain in extremity Pain at injection site during the day and in arm later that night and following day.; Pain at inject... Read more
Pain at injection site during the day and in arm later that night and following day.; Pain at injection site during the day and in arm later that night and following day.; This is a spontaneous report from a contactable consumer. A 58-year-old adult female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration in the right arm, on 05Mar2021 at 12:00 PM, as 1st dose, single for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included Multivitamins, ergocalciferol (VITAMIN D) and Amlodipine. The patient was allergic to sulfa drugs. On 05Mar2021, the patient experienced pain at injection site during the day and in arm later that night and following day. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did not received treatment for the events. The outcome of the event vaccination site pain was recovering and the outcome of the event pain in extremity was unknown. No follow-up attempts are possible. No further information is expected.
58 2021-06-03 seizure, muscle spasms Severe muscle spasms and seizing. Was caught by surprise with the onset and off balance and ended up... Read more
Severe muscle spasms and seizing. Was caught by surprise with the onset and off balance and ended up falling into a wall and broke my arm. now have to have surgery. Also entire arm swollen and black and blue.
58 2021-06-04 pain in extremity Stiffness and soreness on her left arm and up to her neck.; Vaccination site is extremely painful; M... Read more
Stiffness and soreness on her left arm and up to her neck.; Vaccination site is extremely painful; Mld soreness in her arm; Couldnt raise my left arm above my head/ she cant raise her left arm today without slightly raising her right arm; I have been extremely tired/ Shes very tired; Five days after vaccine, I experienced severe pain in my left shoulder and neck constantly; Five days after vaccine, I experienced severe pain in my left shoulder and neck constantly.; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 12:45 (Batch/Lot Number: EN6205) age at vaccination of 58-years-old, as single dose, for covid-19 immunisation. Medical history included breast cancer from 2008 to an unknown date, hypertension from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (known_allergies Penicillin). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Mar2021 at 12:00 PM (five days after vaccine), the patient experienced severe pain in left shoulder and neck constantly. The patient took ibuprofen for 2 days and then took Tylenol. It didn't help much. Then on 07Mar2021 the patient woke up and couldn't raise left arm above head and was extremely tired (she is typically a very energetic person); no treatments were given for these events. The patient also reported that after vaccine (date unspecified) she had a mild soreness in her arm and a few days later had a stiffness and soreness on her left arm and up to her neck, she can't raise her left arm without slightly raising her right arm, she was very tired and vaccination site is extremely painful. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not recovered from the events. No follow-up attempts are needed. No further information is expected.
58 2021-06-06 pain in extremity Have been unable to lift or use my right arm since receiving my second shot, in severe pain have bee... Read more
Have been unable to lift or use my right arm since receiving my second shot, in severe pain have been to 3 different doctors received various medications ( steroids, pain meds anti inflammatory meds and cortisone shots. Also every joint, muscle and bone in my whole body is and has been in severe pain. The shot has seemed to agrivate my arthritis and I can not function or do normal everyday life. I was told my shot was given into my bursa muscle and is due to lack of experience but that doesn't help with all the pain I am in. I need help getting dressed and I have to shower every time I have a bowl movement because it hurts so bad that I can not put my arm back to wipe myself. It has really destroyed my life and the arm could have been avoided if only the person giving the shot was trained properly. I am still going to doctors, I was told to see a rheumatologist. Alot of doctors visits money and medications and still no relief.
58 2021-06-07 weakness Heavy bruising and moderate soreness at injection site 2 hours after vaccination. One bout of Diarrh... Read more
Heavy bruising and moderate soreness at injection site 2 hours after vaccination. One bout of Diarrhea 3 hours after vaccination. Chills started 11 hours after vaccination and continued for 8 hours. Treated with 2 Bayer aspirin every 4 hours. Full body aches (Included head, eyes, back, arms, legs, and general all over body muscle ache) started 11 hours after vaccination and continued for 19 hours. Treated with heat and massage pad, and 2 Advil every 4 hours, but discomfort was not relieved. Occasional: irregular heartbeats. Constant: limbs felt strangely heavy, quickly tired on ordinary short walks, felt out of breath, weak, no energy. Ongoing 2-14 days after vaccination. No treatment received.
58 2021-06-07 muscle spasms, numbness, feeling cold, tingling This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0171), via an unspecified route of administration on 28Apr2021 as 1st dose, single dose for COVID-19 immunization. Medical history included immune deficiency 2 months prior in 2021. The patient's concomitant medications include unspecified medications that the patient has been taking "forever". The patient did not start any new medications recently. She did not have any other vaccinations the same day as the Pfizer COVID-19 vaccine or in the four weeks prior. She says she hadn't had a vaccine in years. The patient reported that she got the vaccine then went grocery shopping and felt great, her arm didn't even hurt, and she didn't feel the shot going in. She says she went to bed and got up 4:00AM to get ready for work, and as soon as her alarm went off on 29Apr2021 she felt really weird. On 29Apr2021, she went to stand up and went to her knees since she couldn't walk and had to crawl to the bathroom. She was in the worst pain in her life/pretty bad pain. Her body was cramping. She was having cramps to her legs and just like every muscled from her foot to her hips and in her hips were cramping, severe cramping, the whole leg. She says she lost feeling and still has some numbness. Patient says her brain is a little foggy as well. The patient took pain medications and Neurontin which is helping her numb feet and tingling in extremities. She also had an icy feeling in her legs, though they are warm always although they feel icy, if she touches them they are warm, like normal body temperature. Patient clarified Neurontin as gabapentin 300 mg, says the doctor has started her out one at night before bed, and she just was given it, so she has only taken two days of it. She says they wanted to see how it affected her, and wanted her to call so they could decide how much to give her, so they started her at the lowest place. She says it didn't effect her worse than she already was, but she thinks they were holding off to see what the neurologist came up with too. The patient also had a little incontinence of bowel and bladder on an unspecified date in 2021. She says she went to the emergency room the day she woke up with the adverse reaction, on the "29th". She says that they gave her Morphine IV. She says that they did no tests, or blood tests, then they sent her home with pain meds and said that this will probably get worse before it gets better, and to follow up with her doctor. She says she followed up with her doctor the next morning. She says that the pain meds made her sleepy, but did not take care of the pain. She says that she went to see her doctor, who sent her to a different hospital, and there she was admit from emergency. She was given an unspecified muscle relaxer which was the one she threw out, her pain wasn't muscle, it was nerve, so she threw it out. She was given Hydrocodone, substituted for Norco. They also gave her, maybe a Tramadol pill, in the hospital. She says she spent 7 days in the hospital, had two ER visits, and doctor visits. The patient underwent lab tests and procedures which included antinuclear antibody: positive 2 months prior in 2021. The patient had her "proteins" tested which were good and also did a spinal tap and were still good in her fluid both on an unspecified date in 2021. The other neurologist wanted to do an EMG (not yet done), because sometimes it can still be fine and not higher proteins. She says mostly they have been going by her symptoms. She has not been diagnosed yet with Guillain-Barre, since she still needs to see a neurologist for the conduction study. She added she will consult with her neurologist, continue to take her Neurontin, and have the physical therapy. The outcome of the events was unknown.
58 2021-06-07 pain in extremity soreness in my left arm that has continued to the present. It has continued to get worse, up until t... Read more
soreness in my left arm that has continued to the present. It has continued to get worse, up until the present. I finally returned home to have it looked at. Have gone to 3 different types of drs in the past few days. I have been told i have frozen shoulder and i believe it is from that shot.
58 2021-06-07 tingling, migraine I was sitting after I got the shot and I started to feel a little off. I felt light headed and wish ... Read more
I was sitting after I got the shot and I started to feel a little off. I felt light headed and wish I would have drank more water before I received the vaccine. I was kind of okay, sitting there waiting, but then I started feeling a weird sensation from the top of my head to the tip of my toes. My skin felt like it was tingling. While I was sitting there I was thinking that I was experiencing anxiety. I received a phone call from my sister that distracted me from my feelings and I felt okay. When I started to leave, I felt light headed and disoriented. I thought I may have been dehydrated. I went to the car and my lips felt like they were swollen, but were physically not. I started feeling like there were pins and needles in my skin. I started to itch in the back of my throat and started experiencing breathing complications. I sat in the parking garage for 40 minutes and debated if I wanted to go back. It was a long walk from my car to the vaccination area. I had my service dog with me and decided to go home. The itchiness went away and I started feeling better for about 24 hours. The next day, I ended up in the ER. I was given Benadryl and in 10 minutes I was fine. Over the next couple of weeks, I started experiencing random heart palpitations. It felt like my heart would skip and jump from time to time. I have not seen anyone yet in regards to my heart. I have had multiple ocular migraines. I still get them now and then after receiving the vaccine. It affects my vision for up to 20 min to an hour after the headache. Bright lights and too much time on my phone and computer causes a problem for my vision.
58 2021-06-07 tingling A feeling of tingling of my hands and feet and arms and legs... I'm feeling some on my torso too..mo... Read more
A feeling of tingling of my hands and feet and arms and legs... I'm feeling some on my torso too..more like little picks or stings/ bites... and like bugs crawling on me.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN9581; Expiration date was not reported), via an unspecified route of administration in the left arm on 04Mar2021 11:00 (at the age of 58-years-old) as unknown, single dose for COVID-19 immunisation at a church. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Medical history included type 2 diabetes controlled with diet and neuropathy experienced with one of the chemotherapy drugs, both from an unknown date and unknown if ongoing; and Breast cancer (which was treated four years ago) from 2017 to an unknown date. Concomitant medications included metoprolol, lisinopril, omeprazole and electrolytes; all taken for an unspecified indication, start and stop dates were not reported. The patient previously took Ciprofloxacin (CIPRO), Clindamycin, Celecoxib (CELEBREX) and Fluconazole (DIFLUCAN) and experienced drug allergy. On 05Mar2021, the patient experienced a feeling of tingling of her hands and feet and arms and legs and some on her torso too more like little picks or stings or bites and like bugs crawling on her. No treatment was taken for the event. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected
58 2021-06-07 tenderness Rash/hives appear randomly over various parts of body, primarily around waist on either or both side... Read more
Rash/hives appear randomly over various parts of body, primarily around waist on either or both sides, have had on inner thighs, front of thigh, buttocks, stomach, right ear, right big toe, left labia?-all start out as small areas, approximately the size of a quarter and then in hours will increase to up to a full palm size, red and tender to touch, extremely itchy, after initial treatment of steroid shot, Methylpred 4mg 21pack, doxycycline hyclate 100 mg and , itching lessened and subsequently went away. By 4/20 rash reappeared. Went to another clinic and received a steroid shot and Prednisone 20 mg , hives went away. Then reappeared around 5/20-5/21 2021. Was treated with another steroid shot. Symptoms improved, returned on 6/5
58 2021-06-07 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hype... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypertension-Severe, Systemic: Tachycardia-Severe
58 2021-06-08 pain in extremity, migraine left arm swelling (injection arm) and pain; left arm swelling (injection arm) and pain; migraines; f... Read more
left arm swelling (injection arm) and pain; left arm swelling (injection arm) and pain; migraines; fatigue; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 58-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7534) via an unspecified route of administration in left arm on 26Mar2021 as 1st dose, single dose and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3247) via an unspecified route of administration in left arm on 16Apr2021 as 2nd dose, single dose for COVID-19 immunization. Patient was 58-years-old at the time of vaccination. Vaccination Facility Type was reported as pharmacy. Vaccine was not administered at Military Facility. Patient did not receive any prior vaccinations within 4 weeks. Patient medical history included ongoing autoimmune disorder (diagnosed 35 years ago). The concomitant medications were not reported. Patient stated she had her first Pfizer Covid vaccine dose on 26Mar2021. She reported having left arm swelling (injection arm) and pain, along with migraines and fatigue on 26Mar2021. She stated those symptoms resolved after a week. She then had her second Pfizer Covid vaccine dose on 16Apr2021. She experienced fatigue and migraines after the second dose, along with pain in her left (injection) arm and restricted movement in this arm. The pain in her arm has continued for about 6 weeks. She called to report this and ask what she can do about it. Patient was concerned that because of her reported side effect (pain in arm for 6 weeks) the vaccine might not have worked correctly. She wants to know if she should get revaccinated if she has had a side effect like this, would this side effect caused her to not make antibodies. Patient has had extensive pain in her arm for 6 weeks after the 2nd dose of the vaccine, states she had the 1st dose on 26Mar2021 and had she expected side effect of left arm swelling and hurting and had migraines and some fatigue and this all went away after a week. Patient stated after the 2nd dose of the vaccine which she had on 16Apr2021, she again had the migraine, was very fatigued and her left arm which was the arm the vaccine was injected into was again hurting as expected but the pain continued and has been going on for 6 weeks and she has some restricted movement. Patient verified the information provided and states she cannot remember when the symptoms began but after the 1st dose it was the same or the next day when the reported events occurred and after the 2nd dose of the vaccine, she was extremely tired and does not remember what got better and what got worse and forgot about it but the pain kind of never went away and the swelling got better and was not as bad but the pain never went away. She had the same symptoms except after the 2nd dose of the vaccine her arm pain got better but never went away and she has restricted movement in her left arm and it began pretty much immediately the same day as the 2nd dose of the vaccine. Patient states she does not know her weight and she wished her weight to be 135 pounds but she was not sure but there may be 15-20 pounds plus. Patient did not receive any treatment for the adverse events. Patient states she does have an autoimmune disorder and has not been experiencing any symptoms from that just some very minor symptoms very recently and was more concerned than most people because she has this autoimmune disorder. Adverse events did not result in emergency room or physician office visit. Description of product complaint included details of the adverse events as experienced by the patient after the first and second doses, lot number details as provided and query about the possibility of production of antibodies after the vaccination as already updated in the initial narrative. On an unspecified date in 2021, the outcome of the events was recovered.
58 2021-06-08 tingling, pain in extremity, numbness tingling; numbness; Feels little lumps and bumps in her arm; dull pain in the upper arm. Is probably... Read more
tingling; numbness; Feels little lumps and bumps in her arm; dull pain in the upper arm. Is probably the worst around the elbow and goes all the way down into the hand and thumb,; This is spontaneous report received from a contactable Nurse (Patient). A 58-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot Number: EN6204), via an unspecified route of administration on 10Mar2021 at 12:00 (at the age of 58-year-old) as 2nd dose, single dose in left arm for COVID-19 immunization at hospital. The patient's medical history included COVID-19 from Dec2020, as she actually got COVID virus over Christmas. Concomitant medications were not reported. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot Number: EN6200), via an unspecified route of administration on 17Feb2021, as single dose in left upper arm for COVID-19 immunization. The patient's historical vaccine included flu vaccine in October, which was the last vaccine she received. On an unspecified date in Mar2021, within a week or two, the patient experienced symptoms that mimicked radiculopathy, where you have a nerve situation that moves down the arm into the fingers, causing tingling and numbness, in the thumb. Patient thought it was maybe thoracic outlet syndrome. Patient experienced dull pain in the upper arm, probably the worst around the elbow and goes all the way down into the hand and thumb and has tingling and numbness. Tingling and numbness continued for a while, tingling comes and goes, but numbness was constant. Dull pain worsened when she was not using her arms, which was strange for radiculopathy. Typically, movement would make it worse. When her arm was still, while watching television or during her sleep, it woke her up. But was almost better while cleaning the house. Patient could feel the declination and was getting worse than before. Patient visited Physician's office, saw surgical physician, and told him about dull pain, tingling and numbness. He ordered a CT scan and some X-rays. Patient assumed a possibility of clot, not deep vein thrombosis or anything. Patient felt like little lumps and bumps in her arm and does not know if it was because of age or what was going on. Treatment medication included Tylenol and ice. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: positive, on an unspecifies date. The clinical outcome of the event dull pain in the upper arm, probably the worst around the elbow and goes all the way down into the hand and thumb, was not resolved. The clinical outcome of all other events was unknown. Follow-up attempts needed. Additional information has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events and the administration of the vaccine cannot be excluded.
58 2021-06-08 speech disorder, bell's palsy Ten days after the first dose vaccine I started to have Stroke like symptoms. I was coming home and ... Read more
Ten days after the first dose vaccine I started to have Stroke like symptoms. I was coming home and my daughter was driving. My daughter asked me why I was stretching my mouth. I did not know this was happening and my daughter said she was taking me to the ER. We called the 24 hour nurse. Two days before I did notice that I got a headache in the evening and it was still there all the next day. I just thought I was coming down with a cold. The headache was still present on the day of the facial symptoms. It was mostly on the left side of my head. The left side of my face is effected by Bells Palsy. I still had mild headaches for two weeks. I still have problems with memory and speech after eight weeks. I feel like I have some good days which are better than others. I have problems with dry eye and balance. The ER doctors diagnosed Bells Palsy. I have been unable to work for eight weeks so far.
58 2021-06-08 tremor Lightheaded; dizzy; heart palpitations; shaking; headache; unable to take deep breaths; This is a sp... Read more
Lightheaded; dizzy; heart palpitations; shaking; headache; unable to take deep breaths; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old non -pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in arm left on 06Mar2021 16:45 as 1st dose, single dose for COVID-19 immunization. Medical history included crohn's disease and known allergies Sulfa from an unknown date and unknown if ongoing. Concomitant medications included multivitamin, ergocalciferol (VIT D), curcuma longa (TURMERIC (CURCUMA LONGA), camphor, cymbopogon schoenanthus oil, menthol, panax pseudoginseng, zingiber officinale oil (GINGER CITRONELLA) , ascorbic acid (VIT C) , ibuprofen (ADVIL), paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient was not had Covid prior vaccination, and the test was not performed post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced lightheaded, dizzy, heart palpitations, shaking, headache, unable to take deep breaths on 06Mar2021 16:45. Treatment was not received for the events. The outcome of the events was reported as recovered on an unspecified date in 2021. No follow-up attempts are Possible. No further information is expected.
58 2021-06-09 burning sensation intermittent nausea the night of vaccine, severe nausea for four days after the vaccine, severe infl... Read more
intermittent nausea the night of vaccine, severe nausea for four days after the vaccine, severe inflammation and tightness in the upper and midback area for four-five days and tightness and inflammation around ribcage on both sides and tightness underneath ribs on both sides mostly the right and around stomach area. worsening of inflammation tightness and burning in across my back more in the center and both sides of my spine as well as inflammation across the rest of my back. Had to double up on my hydrocortisone tablets which are taken for my adrenal insufficiency in order for it to slowly improve. Still had residual effects into the following weekend but mildly improving. THIS WAS MY 1ST VACCINE OF THE PFIZER FORMULA. AFTER TALKING TO HEALTH DEPT, THEY SUGGESTED THAT I FILE THIS WITH YOU. MY NEXT VACCINE IS SCHEDULED THIS SATURDAY ON JUNE 12, 2021 at 2:30 or sooner.
58 2021-06-09 difficulty speaking I had my 1st vaccine on may 21st about 2:30. I woke up 5:45am May 22nd I was hoarse and wheezing, my... Read more
I had my 1st vaccine on may 21st about 2:30. I woke up 5:45am May 22nd I was hoarse and wheezing, my tongue lips and face felt tingly numb and puffy. my ears were hot and itchy also my body felt like my skin was crawling. taking a lot of allergy meds, My mouth is still numb 3 weeks later.
58 2021-06-09 limb paralysis immobility in left arm; Headache through the night; Intermittent pain in right ear; Difficulty sleep... Read more
immobility in left arm; Headache through the night; Intermittent pain in right ear; Difficulty sleeping; Lethargy; Nausea leading to a single vomit; Nausea leading to a single vomit; temperature of 101 degrees fahrenheit; Chills; Rash covering entire trunk of body the following evening; This is a spontaneous report from a contactable consumer. This 58-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 11:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation . Medical history included from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 05Apr2021, administered at 11:15 AM on left arm. There were no concomitant medications and no other vaccine in four weeks. It was reported that on 27Apr2021 at 12:00 AM, the patient experienced headache through the night, intermittent pain in right ear, difficulty sleeping, lethargy, nausea leading to a single vomit, temperature of 101 degrees Fahrenheit, chills immobility in left arm, rash covering entire trunk of body the following evening. The outcome of the events was recovered on unknown date. Therapeutic measures were taken as a result of events included Ibuprofen. Patient had no covid infection or tested positive for covid prior to vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
58 2021-06-09 tremor About 6 hours post vaccine, I woke up with fever, chills and shaking. I took ibuprofen and Tylenol ... Read more
About 6 hours post vaccine, I woke up with fever, chills and shaking. I took ibuprofen and Tylenol . I could not go to work and stayed home. These symptoms lasted about 48 hours. About a week after the vaccine, I started having angioedema. I notice my tongue started to swell. I also noticed my lips and the inside of my mouth was swelling too. It would start from the left inside of my mouth and migrate to the right side. I took Benadryl. The swelling lasted for about 4 days and started to slowly go away. About a week later, I started getting body rashes on random parts of my body. It had it on my ears, underarms, under my breasts, thighs, hands, legs and trunk. The rash would randomly appear and dissapear and could last from 12 hours to several days. I went to se a doctor and was prescribed Allegra, Zyrtec and steroids. I got another 2nd opinion with Dr and got blood work done. I still am suffering from random rashes and notice it will flare up when I don't take my antihistamine medications. The rash is very red, blotchy, can be raised, itchy, painful and very uncomfortable. I never know when I would get them or how severe it may be.
58 2021-06-10 inability to speak, tingling 6/11/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ... Read more
6/11/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: facial tingling, dysphasia. Assessment : Time of assessment 0904. Alert and oriented and anxious. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 0924. VS at 0904- BP- 149/77, 0910- BP- 179/88. P- 58, O2- 100%, 0920- BP- 156/90 Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 0910. Administered by rn. Disposition:Patient evaluated and transferred to the hospital for further evaluation and care. Time of transport: 0924. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 6/11/2021 8:30 AM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8736 NDC: 59267-1000-1 Electronically signed by RN at 6/11/2021 11:05 AM Immunization on 6/11/2021 Immunization on 6/11/2021 Detailed Report Note shared with patient
58 2021-06-13 muscle spasms, pain in extremity Patient stated after she got vaccine she waited 30 minutes, and an hour after she left the facility,... Read more
Patient stated after she got vaccine she waited 30 minutes, and an hour after she left the facility, she started having pains in her side, and her injection site started hurting and swelling. Patient had nausea and dizziness and itching. Patient stated that her right side (where pain was) was swollen, and she had a severe headache. Patient also reported pain in legs and feet. An hour later, patient used restroom and urinated blood. Patient also reported sore throat. Patient stated she bled this way for 3 days after vaccine. Patient has been trying to contact PCP with no answer. Patient reported severe cramping every 30 minutes. Patient is still having severe headaches, and pain in legs and feet, and body aches. Patient stated that lower abdominal pain doesn't come as often anymore. Patient stated that she went to restroom on 06/15/2021 and her urine was reddish colored.
58 2021-06-13 tingling Due to previous reactions to other vaccines per doctor?s suggestion took Quercetin (antihistamine) f... Read more
Due to previous reactions to other vaccines per doctor?s suggestion took Quercetin (antihistamine) few days prior through few days after vaccine. After stopped antihistamine, began experiencing paresthesia throughout my body and have had strong histamine reactions to oxalate containing foods that previously never had issues with. Have never had these issues before. Had to get a prescription for an EpiPen which I?ve never needed previously.
58 2021-06-13 tingling Patient stated she started to feel body pains 10 hours after vaccine administered. Patient administe... Read more
Patient stated she started to feel body pains 10 hours after vaccine administered. Patient administered ibuprofen helped. patient stated for 10 days she was unable to walk well, was better for 5 days, Then was exposed to a family member that was sick then patient felt sick again with body aches and fatigue. Ever since exposure patient has been feeling exhausted, low back pain, tingling in feet.
58 2021-06-15 weakness, muscle spasms funky headache; getting cramps in the arm and hand that I got the shot in; ears were ringing loudly;... Read more
funky headache; getting cramps in the arm and hand that I got the shot in; ears were ringing loudly; muscles and joints ached badly; muscles and joints ached badly; felt tired and weak; felt tired and weak; Checked temp. was 100/temp was up to 104; cough; Felt like I was run over by a truck; Bottom line felt like I was having Covid all over; chills; upset stomachache/stomach was upset/waves of upset stomach; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:45 (at the age of 58-years-old), as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Dec2020 to Dec2020 and started with cough which she had horribly from an unknown date. There were no concomitant medications reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not receive any other medicine prior to COVID-19 Vaccine. The patient was tested COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 03Mar2021 15:00, the patient experienced chills, upset stomachache/stomach was upset/waves of upset stomach. On 04Mar2021, the patient also experienced, ears were ringing loudly, muscles and joints ached badly, felt tired and weak, checked temp. was 100/temp was up to 104, cough, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in. The patient underwent lab tests and procedures which included body temperature: 100 on 04Mar2021, body temperature: 104 on 04Mar2021 When I went to bed My temp was up to 104, body temperature: 100 on 04Mar2021 When I woke up Temp was 100, body temperature: normal on 04Mar2021. Treatment was received for chills and upset stomachache/stomach was upset/waves of upset stomach. Treatment was not received for ears were ringing loudly, muscles and joints ached badly, felt tired and weak, checked temp. was 100/temp was up to 104, cough, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in. The outcome of the events chills, upset stomachache/stomach was upset/waves of upset stomach, ears were ringing loudly, felt tired and weak, checked temp. was 100/temp was up to 104, felt like I was run over by a truck, bottom line felt like I was having COVID all over, funky headache, getting cramps in the arm and hand that I got the shot in were reported as recovering and for events muscles and joints ached badly and cough were reported as not recovered. No follow-up attempts are possible. No further information is expected.
58 2021-06-15 feeling cold stiffness and muscle ache that came and went; stiffness and muscle ache that came and went/ muscle s... Read more
stiffness and muscle ache that came and went; stiffness and muscle ache that came and went/ muscle stiffness in neck; chilled, could not get warm; soreness in her arm at the injection site and shoulder region; fatigued; traveling tingling, stiffness, and tightness in muscle; This is spontaneous report from a contactable consumer. This a 58-year-old female consumer (patient) reported for herself that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: EN6198) intramuscularly into the left arm (in shoulder area) on 04Mar2021 (at the age of 58-year-old) as single dose for COVID-19 immunisation. The patient medical history included asthma, allergies. She does have a tendency to have (for no particular reason), a weakened immune system. She gets sick easy. Concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: EL9269) intramuscularly into the right arm on 11Feb2021 around 11:45-11:50AM (at the age of 58-year-old) as single dose for COVID-19 immunisation which resulted in traveling tingling, stiffness, stiffness in neck, soreness in her arm at the injection site and shoulder region and tightness in muscle. On an unspecified date, the patient reported of stiffness and muscle ache that came and went, muscle stiffness in neck, chilled, could not get warm, soreness in the same shoulder the vaccine was given in and fatigued. She had no tingling in her arm with the second dose. She had normal stiffness and muscle ache that came and went. She clarifies the second dose was given in her left arm because she still had muscle stiffness in her neck. Her neck was still tender. She has had this muscle stiffness the whole month. With the second dose, she still had the normal stiffness and soreness in the same shoulder the vaccine was given in. With the second dose, the caller confirms she did get muscle stiffness and soreness in her left arm that goes up into her neck, but she did not have the tingliness. She had the same symptoms again in the arm she received the vaccine in except she didn't have tingliness, just the stiffness. It was definitely a lighter reaction that it was initially. For the next 3 or 4 days, she would wake up feeling okay, and end up by the evening, feeling just like she just went out and walked 10 miles- her muscle were stiff, fatigued, and ached. She also was cold and what she describes as being chilled. She did not have the chills, but she could not get warm. This lasted 3 days after the shot but that stopped. She has been checking her temperature. Time the vaccination was given was right around noon, because she knows she waited afterwards until 12:30 or 12:33 or 12:34. She had muscle pains and her neck was still bothering her. She definitely still had stiffness in her neck and muscle going from shoulder to neck. No prior vaccinations (within 4 weeks). Treatment included Tylenol Extra strength both times. She does occasionally take Advil sinus for her sinus conditions. However, she was told to not take Advil within 2 weeks of the vaccine so she didn't have any. She may have taken Loratadine or something like that, something minor. Maybe a Tylenol Sinus for allergy related stuff. The patient did not care to go and do the V-Safe and have it tracked. She knew someone that did but she was not sure if it was one with Pfizer or what but she did not want to be annoyed with it and was told it asks questions every day and all sorts of stuff. She had allergies and she knew she could get a reaction, so it was not alarming and not a big deal when she got one. She was 57 or 58, she believes she was 58 and commented that her brain was not working. Once you get past 50, you do not count and feel old. She explains after the first dose, she ended up staying at the vaccine facility for about 45 minutes. Within 10 minutes of receiving the vaccine, the arm that the shot was given in, started to feel tingly and stiffness. This kind of stiffness went to her fingers. Her arm did not go completely stiff. It was traveling, tingling and stiffness and tightness in her muscle. This did go up into the muscle that goes up into neck, she does not know what muscle that is. It was the muscle that goes up and makes you have a stiff neck if you sleep wrong. Stiffness in her neck was on the same side, clarified later as the right side. This was within the first 10 minutes after the shot and lasted about 20-25 minutes or however long it was past the half hour she had to wait. She stated she know once she reached the half hour point, it was still getting a little bit worse but not much. She waited another 15 minute and by then it had gotten a little better, so she left. She explains with the initial dose and after having the reaction, a nurse came and asked her a bunch of questions and checked her temperature. The nurse kept offering her Benadryl but she declined because she knows Benadryl makes her extremely sleepy. She has asthma and allergies, so she did have an EpiPen and inhaler in case needed for an emergency. She did not use anything and did not take the Benadryl. Contacted her allergist and the allergist said it made sense to them and to continue to monitor what was going on. The stiffness and muscle aches in that arm continued in the same side that whole day and went down into her leg, but it was not bad on her leg. Her leg felt stiff but she would not have noticed the stiffness if it was in both sides. She could tell one leg (right leg) felt funny and the other did not. The tingliness went away within an hour or two. She had what she calls normal vaccination soreness in her arm at the injection site and shoulder region. She did take tylenol, she was advised not to take Advil or anything else. She had no problems the next day. The muscle soreness came back the second night after receiving the first vaccine. She was not at all concerned, she was only reporting this today because she knows little was known and she figured it needed to be and it was good information to have. She does have a history of having shoulder surgery. She has had frozen shoulders in both shoulders within the last 5 years. She has massage therapist and the massage therapist theory is that it goes to where your body is normally weak. No investigation assessment. Outcome for the event stiffness and muscle ache that came and went was resolved and for event muscle stiffness in neck was not resolved, and all other events were unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021268198 same patient/drug, different dose/event
58 2021-06-15 feeling hot runny nose; achy all over; coughing up a lot of clear mucus; Headache; my heart was racing a little;... Read more
runny nose; achy all over; coughing up a lot of clear mucus; Headache; my heart was racing a little; feeling warm; little anxiety; my arm is sore where I got the shot; my temp it was 100; This is a spontaneous report from a contactable Consumer (patient). A 58-years-old Female consumer reported that sahe received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 12Mar2021 at 11:45 (at the age of 58-years-old) at single dose for COVID-19 immunization. Other vaccine in four weeks No, other medications in two weeks yes Medical History included thyroid that was slow on med., high blood pressure and known allergy to Ibuprofen. After vaccination she did a 30 min wait time. She felt a little different like her heart was racing a little and feeling warm. She thought it was having her coat on and little anxiety getting the shot and not eating yet that day. She left got something to eat but still felt her heart racing some. By 4 pm she was achey all over and coughing up a lot of clear mucus, a headache started. This went on till about 10 pm the coughing. Took her temp it was 100. She took 2 Tylenol and went to bed. In the morning she still had some coughing, runny nose, and her arm was sore where she got the shot and some achiness. This again was with her 1st Pfizer shot. The outcome of the events was Unknown. Covid was not tested post vaccination. No follow up attempts are possible. Information about lot/batch number cannot be obtained.
58 2021-06-15 numbness Immediately following the patient's second dose of the Pfizer vaccine on 5/12/21, the patient experi... Read more
Immediately following the patient's second dose of the Pfizer vaccine on 5/12/21, the patient experienced B/L hand and foot numbness. The patient was given Duloxetine by her PCP to address her side effects. The patient reported Duloxetine helped, but she was still experiencing B/L finger numbness. The patient reported she has never experienced these symptoms before.
58 2021-06-15 seizure I took the dosage (1) today and the following day I went to work, felt dizzy and came home feeling a... Read more
I took the dosage (1) today and the following day I went to work, felt dizzy and came home feeling a bit light headed. My husband heard me making some noises at 12 midnight (discovered that I bite my tongue...blood was everywhere) and 911 was called and I was rushed to the hospital's ER for treatment. I can't recall what happened at the hospital or the treatment outcomes because I lost my memory; however, I felt my tongue was swollen and I asked what happened to my tongue. My husband explained that I bite my tongue around 12 midnight while at home. The hospital explained to my husband that I suffered a seizure but I have never had any seizures before taking the vaccine. The doctor admitted her to the hospital at 1:00am and she released at 6:00 am. Her husband was upset because the doctor released his wife too quickly and also stated that they could not contribute the seizure to the vaccine. HIs wife's memory was affected and she could not drive for three months.
58 2021-06-16 electric shock sensation, pain in extremity very sore arm; low grade fever; rash chest and back; electrical shock feeling like upper side of tee... Read more
very sore arm; low grade fever; rash chest and back; electrical shock feeling like upper side of teeth; aches; This is a spontaneous report received from a contactable consumer (Patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9266 and Expiration date was not reported), via an unspecified route of administration, in left arm, on 21Feb2021 at 15:00 (at the age of 58 years), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9262 and Expiration date was not reported), via an unspecified route of administration, in arm left, on 31Jan2021 at 15:00 (at the age of 58 years), as a single dose for COVID-19 immunisation. On an unknown date, the patient stated that very sore arm for 2-3 days onset immediate stayed in bed next day aches, low grade fever better by evening, rash chest and back(shoulders) 3rd day electrical shock like feeling right side upper teeth-lasted about 1 week. AE doesn't require a visit to Emergency Room, Physician Office. There was no treatment received. Outcome of the events was reported as unknown. No follow up attempts are needed. No further information is expected.
58 2021-06-16 nerve pain within the five minutes i felt it in my nerves and i got pinched nerves in both arms it did go away ... Read more
within the five minutes i felt it in my nerves and i got pinched nerves in both arms it did go away after 10 minutes and next day i had diarrhea and upset stomach
58 2021-06-16 pain in extremity Caller states that after receiving both doses of her Pfizer Covid 19 vaccine she has experienced sha... Read more
Caller states that after receiving both doses of her Pfizer Covid 19 vaccine she has experienced sharp pains in her arms radiating down to the back of her legs.; This is a spontaneous report from a contactable consumer(patient). A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: EA0167 and expiry date was not provided) via an unspecified route of administration in the left arm, on 07May2021 and second dose (Batch/ Lot no: EA0179) via an unspecified route of administration, in the right arm on 27May2021 (age at the time 58-years-old) as a single dose for COVID-19 immunization. The patient's medical history included seizure, blood pressure, blood cholesterol, pain for her back and neck as she had surgeries that she broke her neck a few years back and her back what it boils down it was had no cartilage in her back or neck and her bones are rubbing and they are trying to get that all straightened out, asthma and rash. Concomitant medications included carbamazepine taken for seizure ongoing since around 1999-2000, gabapentin taken for pain ongoing from 07May2021, hydrochlorothiazide, amlodipine besilate ongoing from 07May2021 but changed her medications as her cholesterol was so high; atorvastatin calcium taken for blood cholesterol started taking it well over 5 years ago, salbutamol (ALBUTEROL) taken for asthma, formoterol fumarate, mometasone furoate (DULERA) taken for asthma; all three ongoing from an unspecified date and triamcinolone acetonide taken for rash and uses this only when she breaks out, it started when she was born with a rash her and her mom were trying to figure out what was best and she got this as an adult. The patient stated that she tried different soaps for rashes and then got that cream and it was a miracle for her. The patient stated that she started using it in her early 20's. Patient did not receive other vaccine in four weeks of vaccination. No adverse event following prior vaccinations. No additional vaccines administered on same date of suspect. The patient stated that when she got the 2nd dose in her other arm it was left side pain. She had the 1st dose in her left arm on 07May2021 and that that arm was still sore, and the 2nd dose was in her right arm on 27May2021, and that arm was not sore. On 09May2021, patient got sharp lightening pains in her right side and had gotten the shot in her left arm. On an unspecified date after 2nd dose in her other arm it was left side pain. Patient state that after receiving both doses of her Pfizer Covid 19 vaccine she has experienced sharp pains in her arms radiating down to the back of her legs. Left arm was where the shot was received the first dose and then she had right sided arm pain that radiated down the back of her leg. Patient describes the pains as shooting pains that are lightening sharp, quick pains that come and go. Patient got the 2nd shot in her right arm and she is now having left sided shooting pains as she was experiencing before with the 1st shot. Patient had only thing with the 1st shot was the shooting pain from her arm to the back of her leg and it sometimes would stop in the hip area and start in the hip to her leg or her arm and into behind her leg. Patient wasn't having that issue at first, that she has pain but not that kind of pain. Patient was very curious as she has high risk and has health issues and has pain but never that type of pain and it goes through her body quick and comes and goes. She said to do the 2nd shot in her other arm and experienced left side pain, would go away and come back and catch her off guard out of the blue, it would go through her body. The patient stated that it was not on the other side at the same time and she never knows when it was coming, that there was no warning. Patient can't say as it has happened maybe 7 times so far since the 1st shot and she can't tell if it was improving or not as it just comes out of the blue and happens. Cholesterol medication was changed, and she thinks the reason they changed her medication was that every time she would go in it was like her pressure was not going down and it was at stroke level and had to get it down. The patient stated that it was down to 176 which was good for her and she was close to 200 or past that, it was 199 over something or 188 and it was bad. The patient stated that her doctor told her look the last 10 time you have come in your pressure has been high and to try something different and it was working. Patient state that the doctor changed both her cholesterol and blood pressure medications, the patient stated that that the first medication she listed was given for blood pressure, but they gave it to her for pain and the patient told her provider it has her knocked out and she was like just keep taking it until it's in system and that changes. The patient relays she wanted to sleep and couldn't do nothing as she was not herself and she doesn't like how it makes her feel and to get it in her system. The patient stated that she has never been high or drunk, but she didn't feel normal. The patient stated that she would take the medication and turn her phone down. She takes 2 different pumps for the asthma of salbutamol (ALBUTEROL) and formoterol fumarate, mometasone furoate (DULERA), supposed to take 2 puffs twice a day and wants her to use them every day but one of them if she uses it like that it makes her dizzy, so she uses it when she needs it with shortness of breath or something like that. She uses them together. If she gets short of breath, she grabs one and uses it and if she gets no relief, she uses the other to kick it in, that it sometimes makes her dizzy. She uses the albuterol and only uses the other one if it doesn't work. Since she got the shot, she has not had a reason to use it as she had not had an asthma attack. she has been using this since she found out she had asthma and it has been over 20 years. Reporter seriousness for she got sharp lightening pains in her right side and had gotten the shot in her left arm, for when she got the 2nd dose in her other arm it was left side pain and for it goes through her body quick and comes and goes and left arm was still sore was unspecified. Reporter seriousness for 1st dose on 07May2021 and 2nd dose on 27May2021 was unspecified. After 1st shot draw blood was drawn but she drew the blood from her wrist on that arm that day. Adverse event does not result in visit to emergency room or physician office. The outcome of event was not resolved. Information on Lot/Batch number was available. Additional information has been requested. Additional information has been requested.
58 2021-06-16 pain in extremity Severe body aches; Tiredness; Sore arm; Fever; This is a spontaneous report received from a non-cont... Read more
Severe body aches; Tiredness; Sore arm; Fever; This is a spontaneous report received from a non-contactable consumer. A 58-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 16Mar2021 at 11:00 (at the age of 58-years-old), as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient was allergic to sulfa antibiotics (MANUFACTURER UNKNOWN), trimethoprim (MANUFACTURER UNKNOWN), meperidine (MANUFACTURER UNKNOWN), penicillin (MANUFACTURER UNKNOWN) and amoxicillin (MANUFACTURER UNKNOWN). Concomitant medications were not reported. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 16:00, the patient experienced tiredness, sore arm, fever and severe body aches. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events tiredness, sore arm, fever and severe body aches. The clinical outcome of the events tiredness, sore arm, fever and severe body aches was recovering. No follow-up attempts are needed. No further information is expected.
58 2021-06-17 numbness and pain in extremities Bilateral neuropathy to forearms and hands
58 2021-06-17 pain in extremity Approximately 10 days after I received my second COVID vaccine (Pfizer) my index fingers and thumbs ... Read more
Approximately 10 days after I received my second COVID vaccine (Pfizer) my index fingers and thumbs in both hands became very swollen. The swelling continued to ebb and flow over the next couple of weeks and often included swelling and inflammation in all my fingers and hand joints/knuckles, my left ankle, left toes, left elbow. As of today (6.18.2021, my left index finger is still very swollen and painful with limited mobility and more minor swelling/inflammation is still present in all my fingers, some of my left toes, my left elbow and left ankle.
58 2021-06-17 speech disorder, tremor, weakness, feeling hot She has been afraid to get her second dose; sweating like she is in the sauna; Dizziness; Weakness; ... Read more
She has been afraid to get her second dose; sweating like she is in the sauna; Dizziness; Weakness; Difficulty breathing; couldn't hardly talk, had to whisper; fast heart beat; swelling of throat; shaking really bad; swollen face; she feels hot like she's in a sauna; severe allergic reaction; This is a spontaneous report from a contactable consumer or other non-health care professional. A 58-years-old female patient received bnt162b2 (BNT162B2solution for injection, Batch/Lot number was not reported) via intramuscular route of administration and administered in left arm on 23Apr2021 12:00 as single dose for COVID-19 immunization. The patient didnt had any another vaccines on 23Apr2021. The patient didnt had any another medications prior four weeks. Medical history included angina pectoris from 2006 and ongoing She takes Diltiazem 180mg once daily by mouth. She has been on it for years. Concomitant medications included diltiazem (DILTIAZEM) taken for angina pectoris. On 23Apr2021 at 12:00 patient had a severe allergic reaction to the Pfizer Covid-19 vaccine. Her side effects were difficulty breathing, difficulty swallowing, fast heartbeat, dizziness, weakness, and she feels hot like she is in the sauna. Confirmed details with caller, who said she did not have difficulty swallowing, but did have swelling of her throat and couldn't hardly talk, she had to whisper. She also said she was sweating like she was in the sauna instead of she feels hot like she is in the sauna. Immediately after the Covid-19 injection she had all these symptoms. Within two hours she was completely back to normal. Her mom came to get her in a wheelchair because she was shaking really bad. She used a wheelchair which was provided to her by them. This occurred half an hour after the injection. An emergency medical technician (EMT) came and the caller's symptoms started to dissipate by the time they got there. She said they took her vitals and was told that they were all fine. She does not remember what vital signs were taken or what the results were. She did not get nothing after getting the vaccine for her side effects. The EMT was going to give her an epi-pen but she declined it. She did not take anything for her symptoms. Caller thought she was supposed to wait a month, which was a couple of days ago. She was listening to the automatic thing and was told she was supposed to wait three weeks. She has been afraid to get her second dose of the Covid-19 vaccine. Her doctor said it was ok to get. caller reports that the EMT did a blood sugar test on 23Apr2021 and initially stated the result was 23. Clarified with caller result is 123. She also had her vitals taken, but does not know the results, she was so out of it. Has regular medications that she has been taking for a long time but doesn't feel that they are relevant. Caller provided no further product names. The patient underwent lab tests and procedures which included heart rate: fast, investigation, physical examination on 23Apr2021.The outcome of events was recovered and outcome of event she has been afraid to get her second dose was unknown.
58 2021-06-18 weakness no energy; wants to sleep all the time; Sick to her stomach; body aches, especially in her legs and ... Read more
no energy; wants to sleep all the time; Sick to her stomach; body aches, especially in her legs and ankles were hurting her.; Unsteadiness on her feet; sporadic headaches; She is having chronic fatigue/I couldnt get off of the couch; loss of appetite; body aches; passed out; This is a spontaneous report from a contactable female consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ERG733, Expiration date: unknown), via unspecified route, administered in left arm on 24Mar2021 15:00 (at the age of 58-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history includes bipolar disorder and history of anxiety. Concomitant medications include Lithium, Alprazolam and Olanzapine, she has been on these medications for 24 years. On 25Mar2021, 9 hours after the vaccination, the patient experienced chronic fatigue, loss of appetite, body aches, no energy, sporadic headaches, and wants to sleep all the time, unsteadiness on her feet and on 26Mar2021 she experienced sick to her stomach. She stated that then Thursday for 2 1/2 weeks till her second dose she was so tired, chronically tired that she would have to take naps by 1400 each day, she couldn't keep her eyes open, and would fall asleep for 2 hours and get up at 1600. She stated that she kept getting these sporadic headaches, body aches, especially in her legs and ankles were hurting her. It seemed to get better close to the second dose. She has never experienced this in 24 years, so she think this is from the vaccine because the vaccine was the only difference in her life. She stated when she passed out on that Thursday and slept all day, it almost felt as if she was in lithium level toxicity. She wasn't steady on her feet. She stated it feels like lithium toxicity. She wanted to know if anyone has reported an interaction with lithium and the vaccine. She has been on Lithium since 1996, for 24 years she has been on 900mg of the product. The caller wanted to know if there is a drug interaction with Olanzapine and the vaccine. The caller wanted to know if there is a drug interaction with Alprazolam and the vaccine. Patient is concerned about interaction between vaccine and concomitant medications. She was taking Tegretol and recently was taken off it. She went through hell the first 2 weeks and then during that third week she was feeling a little bit better, not quite as tired and she is making it through the day without that 2 hours nap. Caller stated the COVID Vaccine had put her mind at ease after she received the vaccination, but what she is experiencing is not normal. She is going to doctor to get blood work, Lithium Level, CBC, thyroid, the full gambit of test on 16Jun2021. The event passed out assessed as medically significant. The outcome of the events limb discomfort was recovered on 26Mar2021, events fatigue, headache and abdominal discomfort was found recovering. Outcome of events asthenia and hypersomnia was unknown, and outcome of reduced appetite and pain was not recovered. No follow-up attempts possible. No further information expected.
58 2021-06-19 numbness, tingling PATIENT STATED HER LEFT HAND WAS TINGLY AND THE FOLLOWING MORNING HER FINGER TIPS WERE WHITE AND NUM... Read more
PATIENT STATED HER LEFT HAND WAS TINGLY AND THE FOLLOWING MORNING HER FINGER TIPS WERE WHITE AND NUMB FOR A SHORT PERIOD OF TIME; PATIENT MENTIONED THIS WHEN SHE CAME TO GET HER 2ND DOSE FOR THE VACCINE
58 2021-06-20 feeling cold, tremor Pt reported feeling very cold, UE cold to palpation and observed UE & LE shaking. AOx3 and able to ... Read more
Pt reported feeling very cold, UE cold to palpation and observed UE & LE shaking. AOx3 and able to follow directions and answer questions. Reports similar allergic reaction to unknown muscle relaxer in the past. Reports sypmtoms did not occur with 1st Pfizer dose. Benadryl 50mg PO administered w/ water at 1225. VSS. Pt reports feeling "much better" shortly after, intermittent shaking continues. Requested to use restroom at approx 1240. Escorted to restroom with family after obtaining stable orthostatic VS and pt reported no dizziness. VS 1220 sitting HR 125, RR 25, BP 145/86, O2 99%RA 1228 sitting HR 71, RR 18, BP 115/66, O2 99%RA 1240 sitting HR 104, RR 18, BP 125/75, O2 98%RA 1242 standing HR 103, RR 18, BP 122/75, O2 98%RA Released w/ family @ 1250
58 2021-06-21 weakness syncope in middle of the night on 4/10/21; felt weak and tired earlier that day
58 2021-06-21 night sweats kidney failure, dehydrated , fever, chills, night sweats, paleness, , ER VISIT, STILL IN HOSPITAL, k... Read more
kidney failure, dehydrated , fever, chills, night sweats, paleness, , ER VISIT, STILL IN HOSPITAL, kidney biopsy.
58 2021-06-21 tingling, night sweats, muscle twitching, weakness Fever, Night sweats so bad have to change several times in the night. Some chest tightness and unco... Read more
Fever, Night sweats so bad have to change several times in the night. Some chest tightness and uncomfortable feeling Nauseous and burning feeling upper stomach Diarrhea Headaches Weakness and tingling in body Hands and feet falling asleep Face twitch - just a little
58 2021-06-22 inability to speak Flu-like symptoms, fever, profuse sweating, extremely sore muscles, extreme fatigue, headache first ... Read more
Flu-like symptoms, fever, profuse sweating, extremely sore muscles, extreme fatigue, headache first 3 days. Flu-like symptoms, fever, profuse sweating improved on 3rd day. Two weeks post 2nd dose, sore muscles continue, extreme fatigue (cannot work/focus/concentrate), headache. Trouble with cognition, trouble speaking clearly (stumbling on words as if tongue/brain are not in sync). Extreme brain fog.
58 2021-06-22 weakness Reported chest palpitations and chest pains and severe itching all over with shortness of breath an... Read more
Reported chest palpitations and chest pains and severe itching all over with shortness of breath and extreme body weakness. temp 101.9. Lot: EW0167 Advised to seek medical care immediately. She said she will follow up with her cardiologist, MD
58 2021-06-22 pain in extremity She states that as she was walking, they felt like cement, got very heavy; arm where she got the sho... Read more
She states that as she was walking, they felt like cement, got very heavy; arm where she got the shot swelled up, was red, and pain was there; arm where she got the shot swelled up, was red, and pain was there; arms started hurting; really bad pains in her legs and feet; really bad pains in her back and side on the right side; side started hurting really, really bad; lower abdomen started hurting/ Lower abdominal pain; head started hurting really, really bad like it was going to explode; whole right side swelled up; started feeling nauseous; throat was also hurting; it was like she was dizzy; started peeing blood; Joint pain; body was aching; skin was itching; arm where she got the shot swelled up, was red, and pain was there; Sinus congestion; basically dropped to her knees. Caller states she was in so much pain; she had recently found out her son and his wife contracted the COVID vaccine/Clarified with caller that she was referring to the COVID virus.; This is a spontaneous report from a contactable consumer(patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0183; Expiration Date: Aug2021) via an unspecified route of administration, administered in Arm Left on 21May2021 12:30(at the age 0f 58-year-old) as single for covid-19 immunisation. Medical history included nephrolithiasis from 2021 and ongoing, Kidney stones, lupus-like syndrome from Nov2019 and ongoing, lupus, rheumatoid arthritis from Nov2019 and ongoing, rheumatoid arthritis, gastroenteritis radiation from Feb2019 and ongoing, chemical colitis, haematuria from 30Jan2021 and ongoing, Recurrent haematuria, arthralgia from Aug2020 and ongoing, Joint pain, ocular hyperaemia from 22Jun2020 and ongoing, Floaters in her eyes, cardiac failure, Heart failure.The patient's concomitant medications were not reported. The patient experienced she had recently found out her son and his wife contracted the covid vaccine and she clarified that she was referring to the covid virus. on 21May2021 arms started hurting, really bad pains in her legs and feet, really bad pains in her back and side on the right side, side started hurting really, really bad, lower abdomen started hurting/ lower abdominal pain, head started hurting really, really bad like it was going to explode, whole right side swelled up, started feeling nauseous, throat was also hurting, it was like she was dizzy, started peeing blood, joint pain, body was aching, skin was itching, arm where she got the shot swelled up, was red, and pain was there, sinus congestion, basically dropped to her knees and patient stated that she was in so much pain. she stated that actually is trying to reach her doctor and she couldn't take the shot on Friday, 11Jun2021, says the doctor told her not to take the shot until she could see her regular physician about everything, including the peeing incident. she wants to see her doctor and ask to see a gynaecologist, says those are things she's going to do before she takes the second shot. The patient underwent lab tests and procedures which included computerised tomogram: kidney stones. They diagnosed her kidney stones and haematuria or whatever it was about a month ago. The outcome of the events headache was not recovered, nausea was recovering and remaining events it was unknown.
58 2021-06-22 pain in extremity Client with left arm soreness and swelling the night of injection, woke with enlarged lymph node in ... Read more
Client with left arm soreness and swelling the night of injection, woke with enlarged lymph node in left side of neck and axillae, with nodule noted left clavicle area. Client to follow up with her PCP.
58 2021-06-23 weakness, numbness, tingling Approximately 5 mins after vaccination, patient notified writer that she was "having some sort of re... Read more
Approximately 5 mins after vaccination, patient notified writer that she was "having some sort of reaction." Reported feeling numbness and tingling in all four extremities, also reported feeling "heavy" and weak. Patient then complained of pressure in the chest and tightness in the throat. Epi pen administered to L thigh and EMS activated. Vital signs stable, patient transferred via EMS to local ER for evaluation.
58 2021-06-23 weakness Started with smelly urine which I thought was an odd reaction from the vaccine but it began right af... Read more
Started with smelly urine which I thought was an odd reaction from the vaccine but it began right after the vaccine for a week or so. Then started getting a strange side ache. Went to my doctor, I had a Bladder Infection ( I am not prone to either UTi,s or bladder infections) I still feel I need to go back to the doctor to follow up; I don?t feel exactly right. Also definitely body aches that have lingered, lower energy levels and some brain fog. I waited to report because I had convinced myself that these symptoms were not related to the vaccine. But now I think they are. More and more people are reporting similar side effects.
58 2021-06-23 pain in extremity Immediate symptoms arm pain, dizziness then within an hour bad headache. Arm pain pretty bad for al... Read more
Immediate symptoms arm pain, dizziness then within an hour bad headache. Arm pain pretty bad for almost 2 weeks. Arm pain had just gotten better and I went for a routine nuclear stress test. The evening after the test I was woken by thump in my back and chest about 5 times. After waking, I would become extremely dizzy. I got up went to the bathroom each time. Every time I tried to go back to sleep I would be woken by thump again. Byy Wednesday I was in the ER with Tachycardia. Pain in left side and heart racing continued. I was in the ER again 4/30 and 5/3. I lost 10 Lbs My left side pain throughout my ribs, back, should blade and stomach distension still occurring. The left side of my back and my left breast are swollen. I have had mammogram, CT scan, ultasound and MRI's plus many visits and calls to many different specialists - heart, GI, Endocrinologist, OBgyn, and primary care doctors over the past 2 months with no answer as to what occurred. I am taking metropol for the heart racing and it has helped but the left side swelling and pain is persistent. I am not sure if this relates to the shot but maybe a combination of the 2? I do not know what happened to my body, but have never experienced anything like this before. And I had a nuclear stress test at age 40+ with no problems. My heart was fine but it was completed because of family history, lyme disease and babesia.
58 2021-06-24 numbness, tingling Within first 30 minute: eyes itchy and watery, lips tingling. On 6/14/2021 (3rd day after shot): bot... Read more
Within first 30 minute: eyes itchy and watery, lips tingling. On 6/14/2021 (3rd day after shot): both sides of body-arms and hands got numb, weak and tingly. Hands were difficult to move. Both sides of jaw got numb and tight. Lips were extremely tingly.
58 2021-06-24 numbness Numbness on left side of body, starting with the foot and going up; This is a spontaneous report fro... Read more
Numbness on left side of body, starting with the foot and going up; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6202 and expiry date was not provided), via an unspecified route of administration in the left arm on 25Feb2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Patient did not have any known allergies. Patient's medical history was not reported. Concomitant medication included pravastatin. Patient had previously received first dose of BNT162B2 (Lot Number: EN5318) in left arm, on 02Feb2021 at 16:00 (at age of 58-years-old) for COVID-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 05Mar2021 at 08:00, patient experienced numbness on left side of body, starting with the foot and going up. This started 7 days after vaccine. Comes and goes every day still. Adverse events result in visit to Doctor or other healthcare professional office/ clinic. No treatment was received. The outcome of events was not recovered. Information on Lot/ Batch number was available. Follow up letter has been generated for further information.
58 2021-06-24 pain in extremity The first shot, I just had sore arm; This is a spontaneous report from a contactable consumer (patie... Read more
The first shot, I just had sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736, Expiration date: Jul2021) intramuscularly on the right arm (shoulder) on 23May2021 (at the age of 58-year-old) as single for COVID-19 immunization. Medical history of the patient included rheumatoid arthritis (2010- not clarified), and asthma, it might have been, patient haven't had wheezing and it might have been about 2 weeks ago. Concomitant medication included Diclofenac Sodium Topical Gel, 4 times a day (1%, Atopic cream) taken for rheumatoid arthritis, Prednisone 5 mg once a day taken for rheumatoid arthritis, Hydrocodone 10 mg taken for rheumatoid arthritis, Albuterol (Salbutamol) taken for asthma. Patient did not receive any prior vaccinations within 4 weeks. On an unspecified date, the patient had sore arm after the first dose. Patient did not receive any treatment for the event. The outcome of the event was unknown.
58 2021-06-25 muscle spasms, pain in extremity I think its like a cramp like a shock and pain and like it go through my knee; I think its like a cr... Read more
I think its like a cramp like a shock and pain and like it go through my knee; I think its like a cramp like a shock and pain and like it go through my knee; A cramp like a pain; There is anything is go out of here in my leg and pain in like in my thigh area,; Both my knees thats what I felt, each day it got worse/I notice the next day is like kind of pain going to my knee.; It stop me for walking its not good; Both my knees thats what I felt, each day it got worse/but its what I see every day its being worse; It is looking abnormal for me; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0217), via an unspecified route of administration on 07Jun2021 as dose number unknown, single for covid-19 immunization (at the age of 58-year-old). Medical history included blood pressure measurement -Verbatim: Blood pressure. Concomitant medication(s) included lisinopril (LISINOPRIL); atorvastatin (ATORVASTATIN); amlodipine (AMLODIPINE); pravastatin (PRAVASTATIN). On 08Jun2021, the patient experienced that she think its like a cramp like a shock and pain and like it go through her knee, a cramp like a pain, there is anything go out of here in her leg and pain in like in her thigh area, both her knees thats what she felt, each day it got worse/She notice the next day is like kind of pain going to her knee, it stop her for walking its not good but its what she see every day its being worse. It is looking abnormal for her. She had never feel anything like this. Treatment: Consumer stated, the day she went, she did not receive any treatment for this probably, going to use this, can noticeable today at work. The outcome of all events were not resolved.
58 2021-06-26 pain in extremity Pain in left arm and shoulder since the first vaccine. Now pain has become debilitating. I am not ... Read more
Pain in left arm and shoulder since the first vaccine. Now pain has become debilitating. I am not able to use my arm.
58 2021-06-26 pain in extremity Patient reported to have severe arm pain for 4 to 5 days following Pfizer dose #2, fatigue. Patient ... Read more
Patient reported to have severe arm pain for 4 to 5 days following Pfizer dose #2, fatigue. Patient still have sore arm and contact her doctor. Her doctor said injury may have gone into bursa, muscle weakness and fatigue; and wanted her to report to us.
58 2021-06-27 breast pain I am post menopause. I immediately started having symptoms of a period trying to start. Ovary throb... Read more
I am post menopause. I immediately started having symptoms of a period trying to start. Ovary throbbing, back ache, and sore nipples.. had these symptoms since the shot and yesterday I started a period for the first time in well over a year.
58 2021-06-28 tingling, numbness One day 1, after vaccine, patient had flu-like symptoms with low grade fever, nausea, headache, bod... Read more
One day 1, after vaccine, patient had flu-like symptoms with low grade fever, nausea, headache, body aches x 4 days. Around day 3, symptoms of severe headache with stiff neck and dry cough started along with tingling and numbness of shoulders, arms, hands, lips, legs bilaterally. These symptoms continue today.
58 2021-06-29 pain in extremity Let me first of all say that I have a long history (since childhood) of my body sometimes reacting e... Read more
Let me first of all say that I have a long history (since childhood) of my body sometimes reacting extremely to something that normally causes no issues. It is very likely that my current issues are simply due to that and not at all due to my COVID vaccines. My main doctor asked me about my vaccine timeline, when I told him about my PICC line problems (detailed below), but it seems like my issues would've happened regardless of any vaccines. I'm just entering this info in case you find that other people are having similar experiences. My only reaction to my first COVID vaccine on 2/24/2021 was soreness in my right arm that lasted for several days. In fact, my reaction was so mild that I was afraid I had not made any antibodies as my immune system had been suppressed from the Rituxan infusions. We'd held off on those infusions so my body would develop some B-cells and I could have the vaccine. Later, tests after my second shot showed that I made lots of antibodies. Several weeks after my first COVID vaccine, I was unexpectedly hospitalized following a routine bronchoscopy when a serious infection was discovered in my lungs. In hindsight, that infection had been there for at least a year or two. The clinical staff inserted a PICC line in my right arm on 3/18/2021. Two days later, as we drove six hours to our home, my arm began to ache. Over the next several days and weeks, that escalated to non-stop discomfort where it felt like my right arm was trapped in a tight blood pressure cuff. Initially, we all just thought that I needed more time to get used to the PICC line (with no way of knowing how the problem would escalate), so I went ahead and had my second COVID-19 vaccine on 3/22/2021 in my left arm. Again, the only reaction I had was to get a sore left arm. My right arm muscles continued to worsen, clenching up until my arm could not extend beyond a 90-degree angle and was largely non-usable, with my right hand going numb. I then broke out in a rash on that arm from wrist to close to my shoulder. X-rays/ultrasounds revealed that the PICC line was inserted correctly and there were no blood clots. When the PICC line was removed, I regained sensation in my right hand, but still could not use my arm. My rheumatologist prescribed gabapentin to settle down my nerves, but I broke out in a rash from thighs to neck, including internally in my ears, anal opening and vagina. After that, I just used ibuprofen and a heating pad on my arm and eventually it became usable again although it still is not fully OK. On 5/3/2021, I had a lobectomy to remove the infected right, upper lobe. Prior to the surgery, my right arm had recovered to the point that I could do most things with it (although it still felt weak). Following the surgery, I did great until six days afterwards when the nerves in my abdomen became so inflamed that even the lightest touch of fabric on my skin was almost unbearable; and the vibrations from being in a car made me grit my teeth and break out in a sweat. Additionally, my legs started having spasms every morning when I awoke, with those spasms racing up and down my legs and into my chest where the surgery had occurred. Eventually, I could stand up each morning, but I have to brace myself against the bed, so I don't fall down because my legs buckle like a newborn baby giraffe until the muscles regain control. That is still going on. Three weeks ago I also developed joint inflammation which I never had before other than occasional knee pain. My doctors told me that these are very unusual and unexpected reactions to this surgery. I am in surprisingly excellent health other than the autoimmune issues. Another thing, cytochrome P450 genetic testing shows that my body does not metabolize some medications correctly. I've also been diagnosed with malignant hyperthermia after a bad reaction to succinylcholine. I might be having these issues due to a medication/sedation reaction; a new flare-up of vasculitis; my body just having one of its strange unexplained reactions; a combination of all those or something else. Since the issues began between my vaccination dates, I am just letting you know what happened. I would not say this was an adverse vaccine event, but I know you need people to report unusual reactions. So here's my story. If you make sense of it, please let me know, because it has baffled my healthcare team and me! I am enrolled in a study of vasculitis patients who have had the COVID vaccine and will send them this same info. So many healthcare professionals have been involved at various steps these last few months that none of them has all the details, which is why I did not list one of them for you to contact. However, I could put you in touch with them and could also share my recent lab work if you need that.
58 2021-06-29 pain in extremity I had COVID back in March 2020, and was left with long hauler syndrome. The intermittent symptoms th... Read more
I had COVID back in March 2020, and was left with long hauler syndrome. The intermittent symptoms that I still have going into the 1st dose are sore neck, exhaustion, heart racing, SOB, hair loss, hypertension, brain fog and decreased cognitive function. Start on the next day after the vaccine, my arm felt a little warm and a little sore. On day 3, at the injection site, it was raised and red about the size of a quarter and my arm was sore and swollen. No medication taken at this time. By day 7, I started getting extreme fatigue, shortness of breath, bad head ache, my neck seemed to be swelling and body aches and pains and racing heart rate. This was followed by nausea, ache and pains and low grade fever which lasted a week and starting the improved. On 3/25/2021 I went to get a COVID test as recommended by my doctor, which was negative. On 3/26/21, I got a flu test, also negative. On 3/27/2021, I got another COVID test, also negative. I also got an antibody test at a walk in clinic which was negative for COVID antibodies. Currently, I am still having mild to moderate COVID like symptoms.
58 2021-06-29 tingling, electric shock sensation From patient written report : "After my first dose, it took about 20 minutes, I felt pressure on my ... Read more
From patient written report : "After my first dose, it took about 20 minutes, I felt pressure on my chest and had a metal taste in my mouth. After an hour or so, I had a needle sensation in my hands and feet. In my left leg, it felt like electricity was shooting through my leg. It took a few weeks for most symptoms to subside. My taste is still not right, many things are now bitter. I find that my hands are still swollen. Still have a slight needle sensation in my hands and feet. My right arm where I had the shot never hurt."
58 2021-06-30 muscle spasms The right side of my back had extreme cramping; therefore, I went to bed and took Motrin and then th... Read more
The right side of my back had extreme cramping; therefore, I went to bed and took Motrin and then the next day it was still really sore. I went to the doctor the very next day (physical exam, blood work, and took x-rays but didn't find anything).
58 2021-06-30 tingling, numbness Have a bump in the area where she got the injected; Tingling in her nerves, like weird stimulations ... Read more
Have a bump in the area where she got the injected; Tingling in her nerves, like weird stimulations in her nerves/tingling from arm to the neck; numbness in arm; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173, and expiry date: not reported)dose 1, via an unspecified route of administration, administered in arm on Jun2021 (at the age of 58years) as single dose for covid-19 immunisation. Medical history included arthritis, gastrooesophageal reflux disease (GERD), allergy. The patient's concomitant medications were taking medications for GERD and for allergies (she had allergies and arthritis). No investigation assessment done. The patient had received her first dose in the beginning of Jun2021 and she was experiencing side effects as like tingling in her nerves, like weird stimulations in her nerves (start date: Jun2021) and she also had like still have a bump in the area where she got the injected (start date: Jun2021) with the COVID 19 vaccine, and she told the tingling all the way from the injection site into her full arm into like a finger and then all the way back into her neck. The patient was experiencing some side effects such as tingling in the nerves, bump at injection area, numbness in arm (start date: Jun2021), and tingling from arm to the neck. Events were being still experienced and, it was actually seemed to be getting worst. It was still the same, like she said it seemed to be getting a little bit worse, the more she used her arm like it seemed to be more persistent and was not 'intermittent' anymore. No treatment was done for events. The outcome of events was not recovered.
58 2021-07-01 burning sensation, tingling, nerve pain, pain in extremity About 5 weeks after my second shot I developed tingling in both arms from the elbow down. At first i... Read more
About 5 weeks after my second shot I developed tingling in both arms from the elbow down. At first it felt like mild carpel tunnel but the pain became so severe that I went to the ER at hospital on June 13, 2021. The pain has progressed to severe nerve burning on the left side from my shoulder down and on the right side from my elbow down. It is so severe at night that it prevents me from sleeping. I have intense joint pain in all the joints of both hands and wrists.
58 2021-07-01 discomfort, numbness, pain in extremity Upper and forearm pain; felt weird; Numb feeling; Little discomfort; This is a spontaneous report fr... Read more
Upper and forearm pain; felt weird; Numb feeling; Little discomfort; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERZ613) via an unspecified route of administration in right arm on 22Mar2021 at 16:15 (at the age of 58-years-old) as first single dose for COVID-19 immunisation. The patient had no relevant past medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medication included melatonin 5mg (MANUFACTURER UNKNOWN) taken in some nights for an unknown indication. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 22Mar2021 at 16:15, the patient got the vaccine shot which felt weird when it happened, got deep numb feeling but no feeling of being pricked by needle. It seemed to take a little longer than expected. She had seen her dad get his and counted to 3 each time and she kept counting with hers, not sure when it got over. The patient felt that the injection was too high on her shoulder and told the clinician about it. It felt weird. The clinician said that the patient should have felt the stinging but she never felt that. After 15 minutes, the patient asked a different worker if the injection was too high and she said 2 or 3 fingers was appropriate and that it seemed okay. Injection looked to be at about where the third finger would be from her shoulder bone. It was higher than she has had shots before. The patient felt a little discomfort. At 18:15, two hours later, the patient experienced pain in her upper and forearm and had continued. Holding arm, it did not hurt but felt sore. There was sharp pain while movement especially in the upper arm. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. Therapeutic measures taken included putting a heating pad on upper arm for about an hour for the reported events. The clinical outcome of the events felt weird, deep numb feeling, little discomfort and upper and forearm pain were not recovered. No follow-up attempts are needed. No further information is expected.
58 2021-07-01 migraine runny nose; migraine headache; Slight headache; Muscles hurt; Little bit of chills; UTI; cough; This... Read more
runny nose; migraine headache; Slight headache; Muscles hurt; Little bit of chills; UTI; cough; This is a spontaneous report from a contactable consumer reporting for herself. A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0164; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 14Jun2021 11:00 (at the age of 58-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. The patient did not have prior Vaccinations (within 4 weeks). Family Medical History included cancer, high blood pressure, heart attack, kidney cancer, breast cancer. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0186) in left arm on 24May2021 13:00. The patient experienced cough on Jun2021, runny nose on an unspecified date, UTI (urinary tract infection) on 16Jun2021, slight headache on 17Jun2021, muscles hurt on 17Jun2021, little bit of chills on 17Jun2021, migraine headache on an unspecified date. Caller wanted to know if the adverse events that she is experiencing are included among the commonly reported adverse events from getting the Pfizer Biontech covid-19 vaccine. She was mostly concerned about the cough and runny nose. In response, patient was given overall safety summary that in clinical studies, adverse reactions in participants 16 years of age and older included fatigue (62.9%), and chills (31.9%). No specific information for coughs and runny nose being a effect, patient was referred to HCP. Caller stated that she was unsure if the cough and runny nose that she was experiencing were the signs of covid-19 or an AE of the Pfizer BioNTech Covid-19. The vaccine was at 95% efficacy 7 days after the 2nd dose of the Pfizer Biontech covid-19 vaccine. It may not protect everyone from covid-19. Patient was requested to speak to her doctor/hcp for some guidance as the cough/runny nose she was experiencing may require extensive evaluation to assess if it was an AE of the vaccine or a symptom of covid-19. Upon follow-up on 21Jun2021, patient reported additional events she experienced which included UTI, slight headache, muscles hurt, little bit of chills. Reason for the patient taking Covid Vaccine was that she was hearing a lot of announcements that Covid has been reported as decreasing. Patient had the second shot of the Covid vaccine on 14Jun2021. Her doctor prescribed her medication two days later for a UTI. She was just calling about this cough too and asked if that is normal after the Covid vaccine. She had a cough off and on and sometimes gets sniffles. She was going back to work the day later this report. She asked if that was okay since she had the shot last week. The medication the doctor gave her for the UTI was Nitrofurantoin and the next day to this report was her last day on it. She was taking 1 tablet twice a day. The cough started Saturday and it was off and on. She called Doctor's office, then she guessed her assistant called back and said she should call Pfizer and where she went to get the vaccine. She should ask them if it was normal to cough this way after the vaccine. Cough started the past Saturday or Sunday, 19Jun2021 or 20Jun2021. Thursday, she had a slight headache, her muscles hurt, and a little bit of chills. She slept all day. She still had a slight headache, but she was thinking that was because of the UTI medicine which can cause some headaches. She was trying not to take Tylenol or anything because she didn't want to kill the vaccine in her. It was not like a migraine headache, and she only feel it when she was sleeping. The muscle pain and chills went away on Friday, and she had recovered completely from both. She found out she had a UTI when she had her wellness visit and they gave her blood test results. She found out on Wednesday 16Jun2021. She didn't have any symptoms, they just found it during her annual visit. Everything as far as her other results were normal. That was the only thing they found. She was hearing a lot of announcements that Covid has been reported as decreasing and how it is safe to go back to work and those who are vaccinated can have no mask. It was reported that history included that the only medicine she was taking is the one for her UTI. She wanted to call because her boss said it was worse, she would have to call her primary physician, and he said to call administration site. When she had her lab results from her annual wellness visit, they found the UTI, she had no symptoms. Event onset time (24-hour clock) for slight headache, muscles hurt, chills was reported as 1500 or 1600 and for cough was towards the evening. AE(s) did not require a visit to emergency room or physician office. Patient was not hospitalized. Relevant tests included none. Clinical outcome of the events muscles hurt, little bit of chills recovered on 18Jun2021, events of cough, slight headache were not recovered and for the other events was unknown.
58 2021-07-01 pain in extremity ongoing burning sensation in her throat; neck pain; left shoulder pain/lot of shoulder pain; fatigue... Read more
ongoing burning sensation in her throat; neck pain; left shoulder pain/lot of shoulder pain; fatigue/ very tired; throat was red/Throat definitely red; my left arm hurt me quite, that's where I got the injection; Both earaches bringing in the ear; sore throat; glands are starts swelling now/there is swelling gland/Swelling glands kind of feeling.; left arm hurt; With my ears I can hardly hear you asking me the last question; her vocal cords were swollen; Confused; I am still not feeling well; I feel awful; Frustration/Frustrated; she had fluid in her ear; increase in acid reflux; bilateral earache; ringing in her ear; back of her neck was swollen; This is a spontaneous report from a contactable consumer or other non Healthcare Professional. A 58-years-old female patient received first dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EW0168; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Left on 10May2021 (at the age of 58-years-old) as dose 1, single for covid-19 immunisation. (Reason for no lot number: of COVID-19 vaccine: Other: Consumer stated, EW O or 0 probably it's a 0, EW0168). Medical history included hypertension (Verbatim: high blood pressure), hypothyroidism, PE blood clot and DVC blood clot, hydronephrosis of left kidney, TMJ disorder. Concomitant medications included rivaroxaban (XARELTO) 10 mg daily taken for PE blood clot and DVC blood clot., start and stop date were not reported; levothyroxine sodium (SYNTHYROID) 37 and half mg taken for hypothyroidism (Under active Thyroid), start and stop date were not reported; Ongoing metoprolol 75 milligrams a day (50mg one in the morning and half in the evening 25 mg in evening) taken for High blood pressure, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Family medical history relevant to A.E: Consumer stated, No. On 12May2021, patient experienced burning sensation in her throat, neck pain, left shoulder pain/lot of shoulder pain, fatigue/ very tired, left arm hurt where the patient got the injection, both earaches bringing in the ear, sore throat, throat was red, swelling glands kind of feeling. On an unknown date in 2021, the patient experienced her vocal cords were swollen, bilateral earache, ringing in her ear, back of her neck was swollen, increase in acid reflux, she had fluid in her ear, confused, still not feeling well, feel awful, frustration, glands are starts swelling now/ there is swelling gland. The patient stated that she was getting all kind of conflicting opinions from the doctors that she has seen but always was curious as to whether, what she was dealing was a common side effect after having receive the first vaccine because she held off having the second vaccine because patient was not just feeling well since the first one and don't know what timeline is to get the second one. Patient stated that she thought there is a weekend it would be pretty much gone because I have a lot of friends as such she know it will go after two day well I went into the next week and I was still experiencing all of these things and so she now waited into the next week. Patient stated "I didn't have an appointment so I went to a sister you know of my PCP and saw one of their doctors then they said, all well we dont think its vaccine may be you have allergy take Zyrtec (Treatment), So I took Zyrtec and I took that for the entire week and then it was going into the next week and I still was not feeling well". Patient saw another Doctor and that doctor said, he checked her glands he said your glands are starts swelling. Patient was in the second week and ENT doctor "he said, well, your throat definitely red and so he like, go home and gargle with water but anyways then I saw two other doctors. I saw ENT. I had week because ENT people had long schedule that going to wait your turn so I had waited out. All ENT they looked into my throat they didnt see anything, terrible going on they looked into my ears and said, your ears are clear and then I reached out again another week with that like, I am now like six weeks into this". Patient underwent lab tests which included antibody test: reactive on 14Jun2021. Therapeutic measures were taken by the patient as a result of her vocal cords were swollen included Zyrtec and took medication for 9-10 days but it didnt help so I quit and one time the patient mentioned. Patient stated, The Ibuprofen, I took was 200mg each tablet. Patient took two mortin tablets 200mg each from over the counter and one dose of Tylenol 500mg for pain. Patient stated that "ibuprofen I only took one dose for that one time I took that on 15th that was the first time I took Motrin since the vaccine I don't usually take Motrin because I am not suppose to take it. I had blood, I had blood clot, PE blood clot and DVT blood clot. So, I dont take Motrin very often." Patient queried whether its okay to get the vaccine you know, past the time line, "because I am at 6 weeks now". Consumer stated she was at 6 weeks now and just didnt know what she should, still getting the second dose or not, because she didnt know if she was out of that window time where it's safe to get it. When informed about the Medical Information Department, consumer stated, With my ears I can hardly hear you asking me the last question. Consumer hung up the call. So no further probing including pharmacy details and treatment details could be done. Hence limited information available over the call. The outcome of the events, ongoing burning sensation in her throat, , neck pain, left shoulder pain, fatigue/ very tired, left arm hurt, bilateral earache, ringing in her ear, back of her neck was swollen, neck pain, left shoulder pain/lot of shoulder pain, fatigue/ very tired, my left arm hurt me quite, that's where I got the injection, Both earaches bringing in the ear had not recovered. The outcome of the events, her vocal cords were swollen, increase in acid reflux, throat was red/Throat definitely red, she had fluid in her ear, sore throat, glands are starts swelling now/there is swelling gland/Swelling glands kind of feeling, Confused, I am still not feeling well, I feel awful, Frustration/Frustrated, left arm hurt, With my ears I can hardly hear you asking me the last question were unknown. Information on Lot/Batch number was available. Additional information has been requested.
58 2021-07-02 tingling within a few hours of 1st shot, started feeling "pins & needles" throughout my entire body. Symptom... Read more
within a few hours of 1st shot, started feeling "pins & needles" throughout my entire body. Symptoms still continue even after the 2nd shot; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 20Mar2021 at 10:15 (at the age of 58-years-old) as dose 1, single dose, and again received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EWO158), via an unspecified route of administration, administered in left arm on 10Apr2021 as dose 2, single for COVID-19 immunisation in Health Clinic. Medical history included high blood pressure, cholestrol, pvc's. The patient has no known allergies. The patient has not been diagnosed with covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), metoprolol, amlodipine, atorvastatin. On 20Mar2021 at 12:00 (within a few hours of 1st shot), patient started feeling pins and needles throughout her entire body. Symptoms still continue even after the 2nd shot. The events resulted in Doctor or other healthcare professional office/clinic visit. The reporter considered the event as Serious. Location of injection information is available for all vaccines received on the same date. No treatment was received for the adverse events. The patient has not been tested for Covid since the vaccination. The outcome of the event was not recovered. Follow up needed, further information has been requested.
58 2021-07-05 weakness My back swelled up and was covered with hives and welts. I couldn't lift anything. Several episode... Read more
My back swelled up and was covered with hives and welts. I couldn't lift anything. Several episodes of severe chest pain, I thought it might be a heart attack at first. Exhaustion and not feeling well for about 4 weeks after the shot. Still having diarreha, not sure if it's from the shot or my IBS but I wasn't having it prior to my 2nd dose.
58 2021-07-05 weakness After the first and second dose I was exhausted for a week straight each time. Felt fluish and gene... Read more
After the first and second dose I was exhausted for a week straight each time. Felt fluish and general malaise. The month after receiving the second dose I started coughing wet/dry. It would not stop. I felt very run down and had a hard time taking a full inhale of breath. My oxygen levels were normal though. I saw a pulmonologist who after sending me to get a Chest XRAy, PET scan that my lungs were peppered with fibroids. My lymph nodes were entirely active in all parts of my body. I have been feeling generally sick and very weak over all for months. Lots of pain in my back and front where my lungs are located. I've had a hard time working or standing for any long period of time. My last xray at the beginning of 2020 and was completely clear. My doctor recently put me on Hydroxychloroquine. My doctors seem to be at a loss. I think there is a distinct probability that I have been having adverse reactions.
58 2021-07-05 pain in extremity I started feeling not well at all the day after the second dose, I feel like I am going to pass out.... Read more
I started feeling not well at all the day after the second dose, I feel like I am going to pass out. I feel nauseous. I did pass out two times, once I bent over on the stairs and fell down the stairs and I broke my little finger so I went to the ER. The did a CAT scan to make sure my head was okay as well as an x-ray. My left arm is very sore still and very painful where the shot was. I do not know how much medicine I got and no one at the Health Department will talk to me. I have no clue what that nurse that day did when she gave me the second dose. I am an RN I was for a long time and this nurse had a 5CC Syringe and I know she was not supposed to. The first shot I received, it was correct. And the second dose was way more, nobody will talk to me but something is not right. Now I am supposed to get a cortisone shot to try and calm that down. My arm has not been the same since then and I have not been the same since that second shot.
58 2021-07-06 burning sensation Rash, Burning sensation, bumps, dull headache, metal taste under tongue, foggy brain.
58 2021-07-06 pain in extremity, migraine TIA/ stroke; Migraines even worse; a lot problems like with her memory; Nausea; Confusion; It's almo... Read more
TIA/ stroke; Migraines even worse; a lot problems like with her memory; Nausea; Confusion; It's almost like a headache right between her eyes; Left arm hurt like crazy; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 58-years-old female patient received bnt162b2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: EN6106), via an unspecified route of administration on 18Mar2021 (at the age of 58-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included intervertebral disc degeneration, fracture cracked pelvic bone, Fibromyalgia, nerve compression. The patient's concomitant medications were not reported (patient takes unspecified blood pressure medications). The patient previously took BNT162B2 (lot/batch: EME198), via unspecified route of administration in left arm injection on 26Feb2021 as 1stdose, single for covid 19 immunisation. On an unspecified date, the patient experienced migraines even worse, a lot problems like with her memory, nausea, confusion, it's almost like a headache right between her eyes. On 18Mar2021, the patient experienced, left arm hurt like crazy. On 09Apr2021, the patient experienced tia/ stroke happened a couple of days after second vaccine. Hospitalized for 3 or 4 days. The patients was admitted on 09 Apr 2021. They have her on medications and stuff for it. The patient has not recovered and still having a lot problems like with her memory. She is still being treated for TIA.The patient states it has improved but it's going to be there and monitored and get tests and the doctor said it was ongoing and she has to be careful. On 18Mar2021 the patient went back to get her second dose, because things subsided. A couple days after her second shot she had a stoke. The patient had a TIA and went to hospital for that and went to her heart doctor and said that the vaccine caused the TIA and they recommend that not to take the vaccine again. The patient states she had no problems and had a heart check and everything before she had the injection and everything was normal. No medical problems. The patient states they put her on blood thinners on 24May2021. They ran all sorts of tests. MRI, X-rays, blood work and they said that it was due to the injection. And now she has to take blood thinners which she didn't have to take before. After all the tests the doctors decided the patient need to continue on a blood thinner. She was on a blood thinner when she was in the hospital. Therapeutic measures were taken as a result of nausea (nausea). Meclizine and anti- nausea prescribed on 12Apr2021. Meclizine 25mg, reports this puts her sleep, 30 count. Ondansetron 4mg, every 6 hours as needed, 230 count. The outcome of the event migraines even worse, a lot problems like with her memory, nausea, confusion was not recovered. The outcome of the event left arm hurt like crazy was recovered. The outcome of the event tia/ stroke was recovering. The outcome of the event it's almost like a headache right between her eyes was unknown. Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
58 2021-07-06 cold extremities, pain in extremity, numbness, tingling extreme dizziness, to the point I had to hold on to furniture to be able to walk; intense ear pressu... Read more
extreme dizziness, to the point I had to hold on to furniture to be able to walk; intense ear pressure; My arm that received the injection has a rash, there is a different kind of rash on my other arm; my legs and feet were freezing intermittently to the point I had to wear 6 pairs of socks; worse at fingers and toes/pain in all my extremities/I started having pain in all my extremities; Joint pain; muscle pain; Severe headache; ringing in ears; numb/tingling/itchy face and head; numb/tingling/itchy face and head/I continue to have high sensitivity feelings like numbness in both sides of my face, scalp and both sides of my head and through my jawline; numb/tingling/itchy face and head; lupus "flare up."; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received first dose of BNT162B2 (BNT162B2, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in arm right on 06Apr2021 13:45 (at the age of 58-year-old) as single dose for COVID-19 immunisation. The patient's medical history included systemic lupus erythematosus, breast cancer, mastectomy, autoimmune disorder from an unknown date and unknown if ongoing I had rashes before because of autoimmune disorder. The patient's concomitant medications were not reported. Patient had allergy to sulfa drugs. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021, patient experienced zapping shooting pain in limbs, worse at fingers and toes/pain in all my extremities, joint pain, muscle pain, severe headache, ringing in ears, numb/tingling/itchy face and head, continue to have high sensitivity feelings like numbness in both sides of my face, scalp and both sides of my head and through my jawline, legs and feet were freezing intermittently to the point patient had to wear 6 pairs of socks. On an unknown date, patient experienced lupus flare up, extreme dizziness, to the point patient had to hold on to furniture to be able to walk, intense ear pressure, arm that received the injection had a rash, there is a different kind of rash on patient's other arm. Doctor had advised the patient not to receive the 2nd Pfizer vaccine dose. On 06May2021, patient experienced pain in all extremities. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on 25Apr2021 Blood test. Therapeutic measures were taken as a result of lupus flare up included steroids. patient stated that could not finish the 5 days of steroids because the steroids were exacerbating that sensitive, underlying speeding up feeling I was having all the time, like the feeling you get when you are about to sneeze is the only way can describe the feeling. The outcome of the events zapping shooting pain in limbs, worse at fingers and toes/pain in all my extremities, joint pain, muscle pain, severe headache, ringing in ears, numb/tingling/itchy face and head, continue to have high sensitivity feelings like numbness in both sides of my face, scalp and both sides of my head and through my jawline were not recovered. The outcome of the events lupus flare up, extreme dizziness, to the point patient had to hold on to furniture to be able to walk, intense ear pressure, arm that received the injection had a rash, there is a different kind of rash on patient's other arm, pain in all extremities were unknown. Information on the lot/batch number has been requested.
58 2021-07-07 numbness 3 days after 1st shot, I had had swollen joint on my right thumb, it lasted for 3 days, then I had ... Read more
3 days after 1st shot, I had had swollen joint on my right thumb, it lasted for 3 days, then I had keen pain , lasted for a day. No treatment.
58 2021-07-08 weakness debilitating; continuous headache; intermittent chills; Body aches; fatigue; malaise; This is a spon... Read more
debilitating; continuous headache; intermittent chills; Body aches; fatigue; malaise; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic back pain and compromised immune system due to liver transplant. Concomitant medications included entecavir monohydrate (ENTECAVIR), tacrolimus (MANUFACTURER UNKNOWN), oxycodone (MANUFACTURER UNKNOWN) and morphine sulphate (MANUFACTURER UNKNOWN) for unknown indications. The patient had a history of allergy to bee stings. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since having the vaccine. On 20Mar2021 at 07:00, the patient experienced debilitating, continuous headache for 7 straight days, intermittent chills/sweats, body aches, fatigue and malaise. Adverse events had resulted in doctor or other healthcare professional office/clinic visit. The patient had not received any therapeutic measures for the adverse events. The clinical outcome of the events debilitating, continuous headache for 7 straight days, intermittent chills/sweats, body aches, fatigue and malaise was resolving. No follow-up attempts are needed. No further information is expected.
58 2021-07-08 discomfort, tingling but did want to take a look at the rash; stabbing feeling in her left wrist; left arm injection site... Read more
but did want to take a look at the rash; stabbing feeling in her left wrist; left arm injection site pain/ Left arm pain near injection site going towards her back; tingling on the left arm; rash on the injection site/Rash on arm near injection site that feels like a bump and is itchy; itchiness; right middle and index finger swelling; arm swelling; something was at the back of her throat; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318 at the age of 58-year-old), dose 1 intramuscular, administered in arm left on 08Feb2021 as single for covid-19 immunization in clinic at a fitness centre. Not a military facility. Time the vaccination was given to the patient between 11:45-11:50. Medical history included allergic to bees, penicillin and benadryl (when she got stung by a bee) and thyroid. Lot number, expiration date and manufacture were unknown for penicillin and benadryl as it was couple of years before. When she had stung by a bee (she had EpiPen with her she had not used it she kept ready in case). The Concomitant medications included levothyroxine sodium (SYNTHROID) taken 75 ug, once a day for thyroid (took for 2 years). The patient previously took benadryl and experienced drug hypersensitivity. The patient did not receive any other additional vaccines administered on same date of the suspect drug. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Feb2021 18:00, the patient experienced tingling on the left arm where she got injection, rash on the injection site/Rash on arm near injection site that feels like a bump and is itchy , itchiness, right middle and index finger swelling, arm swelling and something was at the back of her throat. On 09Feb2021 12:00, the patient experienced left arm injection site pain/ Left arm pain near injection site going towards her back. On 09Feb2021 15:00, the patient experienced stabbing feeling in her left wrist. On an unknown date, the patient sated that but did want to take a look at the rash. Clinical course the patient had the first one on (08Feb2021) Monday and was fine and did not feel anything until 6 hours later. On 08Feb2021 18:00, she then had tingling on left arm where she got shot. The patient felt like needles like her hand was falling asleep. Her hand felt kind of big and she looked at her hand and saw that her fingers were swollen. The tingling started 6 hours after receiving the vaccine. It had lessened and comes and goes. Her doctor just said to keep moving her arm. The site was also red and when she passed her hands over it, it feels like a bump and was itchy. The injection was on left arm, but for some reason, she felt the same on right arm. That went away and only lasted a couple of hours. She did not get tingly feeling on right hand, but right hand did had finger swelling that was just on the middle and index finger. When you try to make a first you feel a tightness and that was just on the left side. It had improved when she took Ibuprofen. She took it to help the swelling to go down on shoulder and helped with tingling and swelling of fingers. She could breathe and swallow but did not know if something was swollen. She had not taken motrin this morning yet. When she takes it, everything looks fine for a while. The swelling goes down and she feels better. The patient reported that her left arm near injection site, she is beginning to feel pain going towards back of her arm. The stabbing feeling in her wrist comes and goes. She was not sure if she should take second dose and was scared to get it. The patient received treatment for the events tingling on the left arm and right middle and index finger swelling with Ibuprofen. No emergency room or physician's office was required to the patient. The outcome of the events tingling on the left arm and rash unknow. The outcome of the events rash on the injection site, itchiness, arm swelling, something was at the back of her throat, left arm injection site pain and stabbing feeling in her left wrist was not resolved.The outcome of the event right middle and index finger swelling was resolving. Follow-up attempts completed. No further information expected.
58 2021-07-08 feeling of body temperature change Developed a fever Body felt hot/cold Temperature went up to 101 Body aches I took Tylenol.
58 2021-07-08 numbness, tingling pins and needles in right leg. Leg then went numb. Started toes and increased up leg. Called Doc... Read more
pins and needles in right leg. Leg then went numb. Started toes and increased up leg. Called Doctor and she said to come into office.
58 2021-07-08 pain in extremity Sore arm; fatigue day 2 to 3; dizziness day 2 - current; vertigo day 5 to current; This is a spontan... Read more
Sore arm; fatigue day 2 to 3; dizziness day 2 - current; vertigo day 5 to current; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 14:00 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included Peripheral polyneuropathy and allergies to vicodin, tuna, basil and yeast. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN) and pregabalin (MANUFACTURER UNKNOWN), both for unknown indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 09:00 the patient experienced sore arm, fatigue on day 2 to 3, dizziness from day 2 to current and vertigo from day 5 to current. Therapeutic measures were taken as a result of sore arm, fatigue, dizziness and vertigo and included treatment with valium meclizine. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event fatigue was resolved on 24Mar2021 (day 2 to 3) and for events pain in arm, dizziness and vertigo was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
58 2021-07-08 pain in extremity Stomach indigestion; Nausea; headache; diarrhea; Stomach distended; exhaustion; The morning after va... Read more
Stomach indigestion; Nausea; headache; diarrhea; Stomach distended; exhaustion; The morning after vaccine it hurt toraise my arm; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6205), administered in left arm on 09Mar2021 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to penicillin, imodium, shellfish and bees stings. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), Fexofenadine hydrochloride (ALLEGRA), Diphenhydramine hydrochloride (BENADRYL). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, patient was not tested for COVID-19. Since the vaccination, patient has not tested positive for COVID-19. On 10Mar2021 at 07:00, after the vaccination, the patient experienced pain in arm, around 14:00 he experienced exhaustion. On 11Mar2021, the patient experienced stomach indigestion, nausea, headache, diarrhea and stomach distended. It was reported that, the morning after vaccine it hurt to raise her arm. Around 14:00 PM she was very exhausted all she wanted to do was sleep. The next four days she had terrible stomach indigestion, nausea, headache and diarrhea which probably woke her up out of asleep. It felt like a volcano irrupting in her stomach and stomach was very distended. The patient took tumbs which would not help, but pepsid did help for the most part. The headache was constant, but at times it would go away and then come back. The patient only took Aleve once or twice for headache. Further it was reported that, the patient really did not feel good until the 17Mar2021.The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, exhaustion, stomach indigestion, nausea, headache, diarrhea and stomach distended were recovered on 17Mar2021. No follow-up attempts are needed. No further information is expected.
58 2021-07-10 muscle spasms blood clot right leg in groin area; cyst in left leg behind the knee; Both of her legs started swell... Read more
blood clot right leg in groin area; cyst in left leg behind the knee; Both of her legs started swelling up; muscle spasms in her leg; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0182) via unspecified route of administration in in left upper arm on 09Jun2021 at 11:00am, at patient age of 58-year-old, as a single dose for COVID-19 immunisation. The patient medical history included Covid-19 in Oct2020. The patient concomitant medications was none. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number RA7886) via unspecified route of administration on 19May2021 at 11:00am, at patient age of 58-year-old as a single dose for COVID-19 immunisation and experienced diarrhea. In Jun2021, the patient experienced blood clot right leg in groin area, cyst in left leg behind the knee. This is affecting her health and she has a lot of bills racking up. She had not had any blood clots or anything like this till after the shots. Blood clot and Cyst occurred around the same time. Both of her legs started swelling up. She went to the doctor on 14Jun2021 since both legs were swollen and it would not go away. They did an ultrasound of the vein, a test called HCUS vein extremity was done. She had another test called a DUP scan and one called XTR vein complete. When querying results, she reported that one of the tests found the main clot and then went into check that there was nothing missed. She did not know exactly when the blood clot and cyst started but 14Jun2021 is when it started to take a toll on her body. She knew it did not feel right but did not know why. She was fine before that. Regarding cyst outcome, she can see and feel it more. Sometimes it gets to where if someone were to put their hands around her leg and squeeze real tight with pressure, it is very odd. As treatment, she was on an acetylsalicylic acid (BABY ASPIRIN). She has an appointment made to see a specialist for medical oncology and hematology. Since the second shot she had muscle spasms in her leg so bad that even when she stood up, she could not get it to stop, it was so painful and never had anything like that before. The events did not require a visit to emergency room, but required a visit to physician office. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.
58 2021-07-10 seizure Systemic: Seizure-Medium, Additional Details: After receiving her 2nd covid dose, patient had a seiz... Read more
Systemic: Seizure-Medium, Additional Details: After receiving her 2nd covid dose, patient had a seizure. Patient has a history of seizures and was taken to urgent care by paramedics.
58 2021-07-11 weakness, tingling Started with joint inflammation and pain in right knee and progressed over weeks with overall muscle... Read more
Started with joint inflammation and pain in right knee and progressed over weeks with overall muscle tightness, stiffness and pain. Joints affected are knees, big toes and small bone at base of right thumb. Right knee is the most severe with pain, stiffness and muscle tightness and weakness - making prolonged walking or going upstairs / getting down or up from the floor difficult. Other odd symptoms are random pains throughout muscles/ joints the "move" from place to place and tingling or zapping pains in bones of feet and legs. Toes turn blue/purple. I was fine before the injections and was doing an at home walking program. Can no longer do this without pain and have limited endurance. To me this appears to be an autoimmune reaction.
58 2021-07-11 burning sensation Noticed pinpoint blood dots on the top of my feet. By the next day they were on my ankles and going... Read more
Noticed pinpoint blood dots on the top of my feet. By the next day they were on my ankles and going up my calves. 'Spots' began getting bigger. Saw doctor Thought it was folliculitis and prescribed antibiotic-I did not take Rx as I didn't agree with the dx. Ran bloods. White and red counts were fine. Saw specialist. She believed it it was leukocytoclastic vasculitis. 'Spots" began to get worse-very painful-some ruptured. Right Ankle was swollen and painful-horrible burning sensation. This lasted about 4-6 weeks. During this time the spots started moving up my body onto thighs, tops of hands, forearms, stomach, and some on breasts. It is now 3 months later and while the majority of the spots are gone-healing from the feet up, i still have a lot of discoloration. I continue to get new spots on my forearms and tops of hands, occasionally on legs and stomach.
58 2021-07-11 tingling, numbness and pain in extremities Neuropathy. Pain and pins and needles in upper and lower extremities
58 2021-07-11 tenderness, burning sensation Metallic taste in mouth, lasting 2-3 weeks; symptoms of Urinary Tract Infection (urgency, burning, t... Read more
Metallic taste in mouth, lasting 2-3 weeks; symptoms of Urinary Tract Infection (urgency, burning, tender bladder area, frequency of urination). No treatments were provided by my doctor.
58 2021-07-12 discomfort Swollen lymph node in left neck base, left and right armpit; discomfort and second day is the same w... Read more
Swollen lymph node in left neck base, left and right armpit; discomfort and second day is the same with arm pit discomfort; This is a spontaneous report received from a contactable consumer, the patient. A 58- years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7533) via an unspecified route of administration administrated in the left arm on 25Mar2021 at 13:00(at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to sulpha drugs. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date and for an unknown indication received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration administrated in the left arm on 04Mar2021 at 13:00 as a single dose for COVID-19 immunisation. The patient was also allergic to epinephrine and codeine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 26Mar2021 at 16:00 the day after the vaccine the patient experienced lymph nodes in left neck base swelled and were very uncomfortable. Then lymph nodes in left armpit swelled and caused discomfort, second day was the same with right armpit discomfort. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests which included nasal swab on 20Mar2021 and tested negative post vaccination. The clinical outcome of the event swollen lymph node and discomfort was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
58 2021-07-12 numbness, weakness, feeling cold, electric shock sensation The left side of my body starting at the bottom of my foot went totally numb and weak. It progresse... Read more
The left side of my body starting at the bottom of my foot went totally numb and weak. It progressed right up and across my waist - left side only and up to my chest and then arm. The feeling came back within 15 minutes but has come and gone with less frequency since then. A feeling of coldness accompanies the numbness or just a small shock feeling sometimes. Mainly my upper thigh, calf and arm.
58 2021-07-12 night sweats, pain in extremity urinated and had an odor that came out of her that was so pungent like sulfur and ammonia; sore arm;... Read more
urinated and had an odor that came out of her that was so pungent like sulfur and ammonia; sore arm; chills; night sweats; Taste was definitely altered; headache; doesn't feel like herself; nightmare; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EW0170 and expiration date unknown) via an unspecified route of administration, administered in Arm Left on 04May2021 as dose 1, single dose for covid-19 immunization (at the age of 58-years-old). The patient medical history and concomitant medications were reported as no. It was reported by the patient that on 04May2021 she received first dose of vaccine and stated that she was in the hospital and was fine in perfect health, and after very first dose, on 05May2021 she had sore arm, and three days later on 07May2021 she woke up in the middle of the night and urinated and had an odour that came out of her that was so pungent like sulfur and ammonia. She thought "this was not a UTI" because the urine wasn't cloudy or anything, then she went back to bed. After that in the morning she woke up later and she smelled the same smell again to check if it was in the urine and so she smelled the toilet, but she could not smell it. After that the next time she urinated, she urinated in a container and the urine smelled normal and it appeared that this odour was coming out when the caller was urinating from the kidney or vagina and mentioned that it happened 4 times and then vanished. Then may be 3 days, on an unknown date in May2021, she experienced chills and night sweats where the bed was completely wet to the mattress cover and her taste buds-she can not say she lost her taste, but her taste was definitely altered, even the toothpaste tasted differently, everything tasted differently. After that she was starting to connect the dots like she had covid but knew she did not. She was experiencing the chills and fatigue which was all part of it, and the headache, then that gradually dissolved. Then she kept saying she did not feel herself. She also stated that the chills and sweating were nonstop and later on, it was not as much but the sweats were still there. Then she had a nightmare and every hour on the hour she would have to get up and change from the night sweats. The patient was on the road to recovery. The patient was recovered from the event of urine odour abnormal on 07May2021 and from event night sweats on 13Jun2021 and was recovering from rest of the other events. Follow-up attempts are needed. Further information is expected
58 2021-07-12 pain in extremity Salty bitter after taste by back of tongue; headache; sore arm; This is a spontaneous report receive... Read more
Salty bitter after taste by back of tongue; headache; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207), via an unspecified route of administration in the left arm on 27Mar2021 at 11:15 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. The medical history of the patient was reported as 'Yes'. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient received unspecified medications within two weeks of COVID-19 vaccination. On 27Mar2021 at 11:15, the patient experienced salty bitter after taste by back of tongue, headache and sore arm. The patient did not receive any treatment for the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of salty bitter after taste by back of tongue, headache and sore arm was recovering at the time of this report. No follow up attempts are possible. No further information is expected.
58 2021-07-12 tingling, numbness she felt a numbness and tingling on the left side of her face, that went down to her neck, and on to... Read more
she felt a numbness and tingling on the left side of her face, that went down to her neck, and on top of her hand; she felt a numbness and tingling on the left side of her face, that went down to her neck, and on top of her hand; she felt 'prickliness' throughout her whole body; Numbness in feet, legs, mid calf, both sides of buttocks, and abdomen; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 10Apr2021 (at the age of 58-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Apr2021 the patient experienced within half an hour after 1st dose, she felt a numbness and tingling on the left side of her face, that went down to her neck, and on top of her hand. She added that she had a similar reaction 20 years ago after she received the flu shot. Consumer mentioned that the numbness and tingling seemed to dissipate within 24 hours. She said she informed the nurse about her history with the flu shot but was told that she was okay to receive the 1st dose. 2 weeks after the 1st dose, she felt prickliness throughout her whole body, like a rash was about to happen, but it didn't. Then on the 2-week mark, on 25Apr2021, the numbness and tingling on her left side, and on the top of her hand came back. After 24Apr2021, she felt numbness on her feet, and midway calf up. There was numbness on both sides of her buttocks, and legs, and across her abdomen. She did mention that her abdomen, and the left cheek of her buttocks are better, but her calves are still numb. She also said that the numbness moved around her body, and her left forearm. The numbness in her buttocks and abdomen was better but she continues to have it in her calves. She said her limbs are numb. Consumer also mentioned that she haok not received the 2nd dose yet. She also mentioned that she was not obese, overweight, and sickly. She wants to know what she can expect over the course of her reaction. She said it had already been 2 months already. She said she had numerous test and does not know what else she should do. She wants to know if what she had was an allergic reaction or something else. She wants to know what ingredient of the vaccine could have caused her reaction, and if PEG allergy might have caused it. She said she was sure that the reaction she had was caused by the vaccine. Consumer wanted to know if Pfizer adjusts the dosage of the Pfizer-BioNTech Covid-19 Vaccine for individuals 6 months to 12 years of age. She also wants to know if the dose for children is the same with the dose for adults. States as of this morning she has a referral to go to an allergist to get tested for PEG allergy, was there a pattern of a reaction like the one she has described? Where it starts out just a little then comes back worse in like 2 weeks? Anyone else with this pattern related to numbness and tingling in the body? Do the symptoms resolve over time? Stated that she was not going to put another toxin in her body. She wants to know how long until the symptoms resolve. Have they tied the vaccine to a PEG allergy or toxicity or something? Stated she has spent close to 3000 dollars on test, blood test, ultrasound of her calf, a biopsy on her legs to check for small fiber neuropathy, and now she was going for allergy testing. Event reported as non-serious. Outcome of the events was unknown. Information on lot number/batch number has been requested.
58 2021-07-14 hypersensitivity of all senses, numbness, pain in extremity Approx 1.5 weeks after 2nd dose, pain returned to injection arm and remained for a month. Following... Read more
Approx 1.5 weeks after 2nd dose, pain returned to injection arm and remained for a month. Following this it transitioned into numbness with touch-sensitivity/pain. This continued for 5 mos (and still continues as of this report date) with decreasing area. Started with arm below injection site and over time the affected adverse event area shrunk distally. Currently it is just affecting the distal areas of the left pointer and middle finger from the last joint to tips of fingers.
58 2021-07-14 numbness Right after I got the shot my head started feeling numb, and soon after I started breaking out in hi... Read more
Right after I got the shot my head started feeling numb, and soon after I started breaking out in hives all over. It has gotting a little better, and my head feels better but I still have the hives all over.
58 2021-07-14 nerve pain, pain in extremity, burning sensation I have had neuropathy pain in feet for two years. It has never changed during that time. I had my ... Read more
I have had neuropathy pain in feet for two years. It has never changed during that time. I had my Pfizer vaccine on April 28. Within a couple of days, I had shooting pains up my feet, legs, and into my arms. It has continued to progress, and now I have constant shooting pains, shocking nerve pains, and burning throughout my feet, legs, hips, back, arms and hands.
58 2021-07-14 tingling TINGLING IN LEFT ARM AND JAW. THIS HAS HAPPENED BEFORE AND SHE IS CURRENTLY SEEING A NEUROLOGIST. ... Read more
TINGLING IN LEFT ARM AND JAW. THIS HAS HAPPENED BEFORE AND SHE IS CURRENTLY SEEING A NEUROLOGIST. EMS CALLED FOR FURTHER EVALUATION BUT PT REFUSED TO GO TO THE ER. PT DISCHARGE HOME WITH HUSBAND.
58 2021-07-14 tremor I was itching like crazy for two days, I was shaking I almost passed out, had low grade fever, felt ... Read more
I was itching like crazy for two days, I was shaking I almost passed out, had low grade fever, felt like I was going to pass out, had a severe headache. symptoms lasted for around 4 days. Worst headache of my like.
58 2021-07-17 weakness I am very weak and stillhave some nausea and abdominaldiscomfort.; I am very weak and stillhave some... Read more
I am very weak and stillhave some nausea and abdominaldiscomfort.; I am very weak and stillhave some nausea and abdominaldiscomfort.; I am very weak and stillhave some nausea and abdominaldiscomfort.; Upon waking the next morning,I had a fever of 101.8, very badheadache and body aches. My feverwas as high as 103 and continued fora total of approximately 60 hours.; I started to feel unwell; My first symptoms were headache and bodyaches along with diarrhea.; My firstsymptoms were headache and bodyaches along with diarrhea.; My first symptoms were headache and bodyaches along with diarrhea.; I did not sleep well that night and woke severaltimes.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E P 6955) via an unspecified route of administration in the right arm on 25Mar2021 at 09:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included recent emergency appendectomy on 19Feb2021 and meningioma. Concomitant medications received within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO), mirtazapine (REMERON) and alprazolam (XANAX). Allergies to medications included penicillin and quinolones (quinolones caused throat tightness). The patient did not get any other vaccines within 4 weeks of COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E N 6206) via an unspecified route of administration in the right arm on 04Mar2021 at 08:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 25Mar2021, at 17:00, 8 hours after vaccination, the patient experienced feeling unwell, headache, body ache and diarrhoea. The diarrhoea was constant with 10 to 15 bouts a day, lasting for 72 hours. On the same day, she experienced sleep unwell that night and woke several times. On 26Mar2021, the patient experienced fever of 101.8 and later her fever was as high as 103 and continued for a total of approximately 60 hours. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for fever included extra strength tylenol, 1000 mg, every 6 hours and for diarrhoea included pepto bismol. The clinical outcome of the events feeling unwell, headache, body ache, diarrhoea, sleep unwell, fever, weakness, nausea and abdominal discomfort was resolving. No follow-up attempts are needed. No further information is expected.
58 2021-07-17 bell's palsy When right to ER with stroke like symptoms; Was diagnosed with BELLS PALSY/Paralysis are on my left ... Read more
When right to ER with stroke like symptoms; Was diagnosed with BELLS PALSY/Paralysis are on my left side/mouth twisted; headache; sleep more; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 58-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 16Mar2021 15:45 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Heart Disease, sleep apthy, swelling in left leg and ankle. No known allergies. Concomitant medications included patient took other medications (unspecified) in two weeks. For Adverse events the patient reported as follows: It all began 10 as after her 1st of 2 vaccines. The Pfizer. She went to work for 2hrs. At 6pm she picked her daughter up and she asked why was your mouth twisted. She had not noticed any difference but called the 24hr nurse. When right to ER with stroke like symptoms. Had a headache that started a few days before and would not go away. She was diagnosed with BELLS PALSY. Paralysis were on her left side. Her left eye had to have eyes every few hrs, she slept more. She was not able to work since this had happen and this was the 3rd month. Eyes were still affected, still headaches and eating or chewing food, or drinking was difficult. The start date of events was 26Mar2021 06:30 PM. Events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Events stroke like symptoms and bells palsy were Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment received included steroids for 7 days, (6) pills daily at one time. The outcome of events was not recovered. Patient did not have COVID prior vaccination, and did not have COVID tested post vaccination. Information on the lot/batch number has been requested.
58 2021-07-17 burning sensation, numbness entire head was numb in addition to the top 1/2 of the face; head burning from the inside out and nu... Read more
entire head was numb in addition to the top 1/2 of the face; head burning from the inside out and numb; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: wep6955), via an unspecified route of administration in the left arm on 24Mar2021 at 08:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to food, medications, or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 21:00, the patient felt her head burning from inside out and numb. It felt like she was boiling, however, no temperature. The entire head was numb in addition to the top 1/2 of her face. The patient did not receive any treatment for the events burning sensation and numbness facial. The clinical outcomes of the events burning sensation and numbness facial were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
58 2021-07-17 electric shock sensation I only had pain like in the body ache; I started feeling something under my knee, in front of my leg... Read more
I only had pain like in the body ache; I started feeling something under my knee, in front of my leg under the knee, something like electric in my leg in front; something like swelling but not swelling; On Tuesday morning, felt something on her leg under the knee, swelling and like a bruise of someone who had an injection; When I bent or when I run to in here there is like something inside, it is swelling but something is inside like it shocks me; Have an electric shock in that area when try to bend the leg.; This is a spontaneous report received from a contactable consumer (Patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EZ0196), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Jun2021 (at the age of 58-year-old) as single dose for COVID-19 immunisation. Medical history included surgery in throat in 2016 (Not on medication. It was no medical history. She only had a surgery in throat in 2016 and her thyroid hormones are no more). The patient's concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0186), Solution for injection, via an unspecified route of administration, administered in left arm on 26May2021 as single dose for COVID-19 immunisation. On 22Jun2021, the patient experienced pain like in the body, she started feeling something under her knee, in front of her leg under the knee, something like electric in her leg in front; something like swelling but not swelling, on Tuesday morning, felt something on her leg under the knee, swelling and like a bruise of someone who had an injection, when she bent or when she run to in here there was like something inside, it was swelling but something was inside like it shock her, had an electric shock in that area when try to bend the leg. Patient got the 2nd dose on Sunday, 20Jun2021 on the same arm (left arm), she felt body aches. On Tuesday morning, felt something on her leg under the knee, swelling and like a bruise of someone who had an injection, 'she had an electric shock in that area when she tried to bend the leg'. She had been putting ice on it. Every day, it got more and more stuff which felt like when remove glue from something, that was what she felt on the inside. The outcome of events was not recovered. No follow-up attempts are possible. No expected further information.
58 2021-07-17 feeling hot lient reported 20 mins after receiving vaccine she experienced headache, warmth in ears, and tingli... Read more
lient reported 20 mins after receiving vaccine she experienced headache, warmth in ears, and tingling of the lip lasting 30 minutes. Per client no shortness of breath or swelling. Client stated she did not take any medication or followed up with provider
58 2021-07-17 numbness Dry throat; Numbness around nose and upper lip; This is a spontaneous report from a contactable cons... Read more
Dry throat; Numbness around nose and upper lip; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via unspecified route of administration in the left arm on 25Mar2021 at 10:45 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included hashimoto hypothyroidism. The patient did not have a history of allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included LEVOXYL, ADVIL, cyclobenzaprine (MANUFACTURER UNKNOWN); all for an unknown indication. On 25Mar2021 at 11:00, the patient had experienced dry throat, numbness around nose and upper lip. The patient did not receive treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dry throat, numbness around nose and upper lip was unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
58 2021-07-17 numbness Tingling on the Tongue; numbness on lower left half of face; This is a spontaneous report from two c... Read more
Tingling on the Tongue; numbness on lower left half of face; This is a spontaneous report from two contactable consumers. These consumers [patient's husband and 58-year-old female consumer (patient)] reported that she received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EN6201, Expiration Date: 30Jun2021) via an unspecified route of administration, administered in Arm Right on 10Mar2021 13:15(at the age of 58-years-old) as Dose 1,Single for COVID-19 immunization. The patient's medical history included ongoing type 2 diabetes mellitus Diagnosed 19 years ago. Concomitant medications included insulin (INSULIN),States it is split in to two; for a total of 65 units a day, injection, one morning and one evening. No prior vaccinations (within 4 weeks). Family Medical History Relevant to AE(s) states she has no family medical records because she was adopted. AEs following prior vaccinations includes Arm Soreness from prior annual flu vaccinations. On 10Mar2021 at 13:30 within 15 minutes post vaccination, the patient experienced tingling on the tongue with outcome of recovering, numbness on lower left half of face. Her husband wanted to know if this is normal and what they should do about it. No shortness of breath, no throat swelling. No Emergency Room or Physician Office visit required.The outcome for event tingling on the tongue was recovering and for event numbness on lower left half of face was not recovered. No follow-up attempts are possible. No further information is expected.
58 2021-07-17 pain in extremity, tingling Thought she was getting the expected arm pain. Hours and days went by and it spread around her body.... Read more
Thought she was getting the expected arm pain. Hours and days went by and it spread around her body. Feels like she has pins and needles around her body; As days went by it is worsening; Thought she was getting the expected arm pain. Hours and days went by and it spread around her body. Feels like she has pins and needles around her body; Thought she was getting the expected arm pain. Hours and days went by and it spread around her body. Feels like she has pins and needles around her body; Tingling in pinky and ring finger; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9261), via an unspecified route of administration on 20Jan2021 at 16:00 (at the age of 58-year-old), as dose 1, single in left arm for COVID-19 immunisation at nursing home. The patient's medical history included chicken pox at age 32; and flu vaccine, but it was beyond 4 weeks. Patient did not receive any vaccine within 4 weeks prior vaccinations. Concomitant medications were not reported. On 20Jan2021, right after COVID Vaccine, the patient experienced weird tingling in pinky and ring finger. Patient thought she was getting the expected arm pain. Hours and days went by and it spread around her body. Patient felt like she had pins and needles around her body. Patient doesn't want to get the second shot on scheduled day. Patient was concerned because the pins and needle feeling were not going away. Figured reaction was initially arm pain. It progressively spread around her body. Patient thought it was going to get better, but it didn't. It had been three weeks in. Patient was confident and praying it will go away. Pins and needles feeling occurred every day but stopped and appeared depending on how patient moves. Patient thought it was a nerve problem. Patient never had this. Patient tried to take a lot of vitamins and took care of herself. The clinical outcome of all events was not resolved. Follow-up attempts are completed. No further information is expected.
58 2021-07-17 pain in extremity No sore arm until day 3; Ended up with 5 welts or hive like marks down the arm of the injection site... Read more
No sore arm until day 3; Ended up with 5 welts or hive like marks down the arm of the injection site; Being tired first few days; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 15Mar2021 at 09:30 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included childhood asthma, seasonal allergies, allergic to cats, iodine allergy and fruit allergy (bananas and avocado and peaches). Concomitant medications included escitalopram oxalate (LEXAPRO) from unknown date for unknown indication. The patient also had known allergies to morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 17Mar2021 at 02:00, patient experienced pain in arm, hives and tiredness. The patient reported no sore arm until day 3, ended up with 5 welts or hive like marks down the arm of the injection site. And only one on the other arm. There were no other symptoms except being tired for first few days. The hives were still present. The patient did not receive any treatment for reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the reported events pain in arm, hives and tiredness was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
58 2021-07-17 tingling traveling tingling, stiffness, and tightness in muscle; traveling tingling, stiffness, and tightness... Read more
traveling tingling, stiffness, and tightness in muscle; traveling tingling, stiffness, and tightness in muscle; traveling tingling, stiffness, and tightness in muscle; stiffness in neck; soreness in her arm at the injection site and shoulder region; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 (Batch/Lot Number: EL9269) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing and hypersensitivity from an unknown date and unknown if ongoing . There were no concomitant medications. She does have a tendency to have (for no particular reason), a weakened immune system. She gets sick easy. She is a substitute teacher and she knows when she was going to be teaching little kids, she was going to be sick, but that just was her. She knows its just because she has allergies. She was not sickly but she knows her limits. The patient did not have any prior vaccinations within 4 weeks. The caller explains after the first dose, she ended up staying at the vaccine facility for about 45 minutes. Within 10 minutes of receiving the vaccine, the arm that the shot was given in, started to feel tingly and stiffness. This kind of stiffness went to her fingers. Her arm didn't go completely stiff- It was traveling, tingling and stiffness and tightness in her muscle. This did go up into the muscle that goes up into neck, she doesn't know what muscle that is. It's the muscle that goes up and makes you have a stiff neck if you sleep wrong. The caller states the stiffness in her neck was on the same side, clarified later as the right side. This was within the first 10 minutes after the shot and lasted about 20-25 minutes or however long it was past the half hour she had to wait. She states she know once she reached the half hour point, it was still getting a little bit worse but not much. She waited another 15 minute and by then it had gotten a little better so she left. The caller explained with the initial dose and after having the reaction, a nurse came and asked her a bunch of questions and checked her temperature. The nurse kept offering her Benadryl but the caller declined because she knows Benadryl makes her extremely sleepy. Caller confirmed she doesnot have any UPC, Lot number or expiry date for Benadryl, she didnot take any. She has asthma and allergies so she did have an EpiPen and inhaler in case needed for an emergency. She didnot use anything and she didn't take the Benadryl. Caller states she did contact her allergist and the allergist said it made sense to them and to continue to monitor what was going on. The stiffness and muscle aches in that arm continued in the same side that whole day and went down into her leg, but it was not bad on her leg. Her leg felt stiff but she wouldn't have noticed the stiffness if it was in both sides. She could tell one leg (right leg) felt funny and the other didnot. The tingliness went away within an hour or two. She had what she calls normal vaccination soreness in her arm at the injection site and shoulder region. She did take Tylenol, she was advised not to take Advil or anything else. She had no problems the next day. The muscle soreness came back the second night after receiving the first vaccine. She was not at all concerned, she was only reporting this today because she knows little was known and she figured it needs to be and its good information to have. The patient did not visited to emergency room/ physician office. Therapeutic measures were taken as a result of events with Tylenol Extra strength both times. The outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021268268 same patient/drug, different dose/event
58 2021-07-17 tingling Throat felt tight; Tingling along the right side of the body; This is a spontaneous report from a co... Read more
Throat felt tight; Tingling along the right side of the body; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had known allergies (unspecified). The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 06:00 (the next day after the vaccine), the patient experienced throat felt tight and tingling along the right side of the body. The patient reported this lasted for most of the next day after the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events throat felt tight and tingling along the right side of the body was resolved on an unknown date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
58 2021-07-19 feeling cold, feeling hot woke up nauseous 2nd daylater drank some coffee I small cup took vitamins threw up kept feeling nau... Read more
woke up nauseous 2nd daylater drank some coffee I small cup took vitamins threw up kept feeling nauseous from Thursday until Tuesday . At first after vaccine I felt hot then cold no chills.
58 2021-07-19 pain in extremity, breast pain very large moveable lymph node on left clavicle; whole arm is sore; breast tissue is sore; whole arm... Read more
very large moveable lymph node on left clavicle; whole arm is sore; breast tissue is sore; whole arm and into her breast tissue is sore and into my neck; This is a spontaneous report from a contactable other healthcare professional, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 25Mar2021 at 10:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism, hypertension, cholesterol high, fibromyalgia. The patient had allergy with mold me flex. Concomitant medications received within 2 weeks of vaccination was reported as 'my prescribed meds'. The patient previously received cefaclor (CECLOR) and clarithromycin (BIAXIN), both for an unknown indication and experienced drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 16:00, the patient experienced very large moveable lymph node on her left clavicle, whole arm and into her breast tissue were sore and into neck. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the event very large moveable lymph node on left clavicle, whole arm and into her breast tissue is sore and into neck were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
58 2021-07-19 pain in extremity Since vaccine, chronically tired, spike in cholesterol, constant dry cough, dizziness, problems with... Read more
Since vaccine, chronically tired, spike in cholesterol, constant dry cough, dizziness, problems with eyes focusing. Have not been given medicine as they try to figure out cause of cholesterol spike, leg and knee pain
58 2021-07-19 pain in extremity I have been sneezing for no reason. I have felt soreness in my right thigh but no wounds or injurie... Read more
I have been sneezing for no reason. I have felt soreness in my right thigh but no wounds or injuries. It has progressed to my leg . It is more sensitive when lying down. I have not seen a doctor or suffered severe reactions to the vaccine.
58 2021-07-20 weakness I had fatigue, severe headaches, weakness in the body and body aches, also heaviness of the vaccinat... Read more
I had fatigue, severe headaches, weakness in the body and body aches, also heaviness of the vaccination site. I contacted my DR and had a visit several times in Jan/Feb/March/June 2021. I do not know the exact dates right now as I am working. My DR said I am a long hauler with Covid and have to use Advair inhaler to try and help. My DR made arrangements for me to see a Cardiologist and they did a work up during my visit.
58 2021-07-20 muscle twitching Started with 1st dose. Muscle twitches in lower legs. In the last 2 months, after second dose, incre... Read more
Started with 1st dose. Muscle twitches in lower legs. In the last 2 months, after second dose, increasing.; Started with 1st dose. Muscle twitches in lower legs. In the last 2 months, after second dose, increasing.; Keeping me up at night; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-years-old female (Non-pregnant) patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FR28744), via an unspecified route of administration, administered in am left on 01May2021 at 12:00 (age at the time of vaccination 58-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Known allergies from Aleve, and prior to vaccination, the patient diagnosed with COVID-19. The patient's concomitant medication included losartan (LOSARTAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced started with 1st dose, muscle twitches in lower legs, in the last 2 months, after second dose, increasing; and keeping me up at night. Since the vaccination, the patient has not been tested for COVID-19. The outcome for all the events was not recovered. No follow-up attempts are possible. No further information is expected.
58 2021-07-20 pain in extremity trouble breathing, pain left thigh, dizzy, burning skin,
58 2021-07-20 pain in extremity Localized arm pain; Muscle aches; Fatigue; Vertigo; Headache; Chills; Fever; This is a spontaneous r... Read more
Localized arm pain; Muscle aches; Fatigue; Vertigo; Headache; Chills; Fever; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the arm left on 12Mar2021 at 09:45 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included graves disease, hypothyroidism, afib, vertigo, Hx BrCA w/chemo/radiation (breast cancer, chemotherapy, radiotherapy) and COVID-19. The patient received other vaccine (HPV vaccine VLP rL1 2v (baculovirus)) (Lot number: 95JR5), in the left arm on 12Feb2021 within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), calcium, colecalciferol (CALCIUM AND VIT D), metoprolol succinate (METOPROLOL) and estradiol (ESTRING); all taken for unknown indication from unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021, at 03:00 the patient experienced localized arm pain, muscle aches, fatigue, vertigo, headache, chills and fever of 100.3 within 24 hours of vaccine. The chills and fever lasted only one day while remaining symptoms lasted 3. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for localized arm pain, muscle aches, fatigue, vertigo, headache, chills and fever. The clinical outcome of the events localized arm pain, muscle aches, vertigo and headache were resolved, while that of the events fatigue was resolved in Mar2021 (patient felt fatigue for one week); chills and fever was resolved on 14Mar2021 (lasted only one day). No follow-up attempts are needed. No further information is expected.
58 2021-07-20 tingling whole face started to tingle; had two more episodes of whole face tingling, mild but still not compl... Read more
whole face started to tingle; had two more episodes of whole face tingling, mild but still not completely gone; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6027) via an unspecified route of administration in the right arm on 27Mar2021 at 10:45 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included heart murmur. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), sumatriptan (IMITREX), fish oil (MANUFACTURER UNKNOWN) and acetylsalicylic acid; caffeine; paracetamol (EXCEDRIN) and multivitamins (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date. The patient previously took tetracycline (MANUFACTURER UNKNOWN) and morphine (MANUFACTURER UNKNOWN) and experienced drug allergy to both. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 11:15 (approximately after 30 minutes after shot), the patient experienced whole face started to tingle which lasted for 45 minutes and patient felt fine after that. On 31Mar2021, the patient had two more episodes of whole face tingling, one lasted about an hour, the next was severe and lasted for about four hours and had become mild (at the time of reporting) but still not completely gone away after 24 hours. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of face started to tingle and included monitoring of blood pressure and heart rate (unknown results). The patient had blood pressure and heart rate measurements on an unknown date and the results were unknown. The clinical outcome of the event tingling was recovered with sequalae with the date 27Mar2021. No follow-up attempts are needed. No further information is expected.
58 2021-07-20 tremor, speech disorder Within 24 hours of taking the vaccine my mom was very sick. She could not get out of bed and didn't ... Read more
Within 24 hours of taking the vaccine my mom was very sick. She could not get out of bed and didn't leave her room for two days. She was shaking hard as if she was cold and could barely talk.
58 2021-07-21 weakness, inability to speak, slurring, numbness After 1 got the 1 st dose vaccine, a few hours later around 1pm, I was having blurred vision. I f... Read more
After 1 got the 1 st dose vaccine, a few hours later around 1pm, I was having blurred vision. I felt very tired, nausea and exhausted and I went home and went to bed. I did take some Tylenol to help relieve my symptoms. I also had left leg swelling, my face was puffy and I was just not feeling good. I had problems focusing, brain fog, complete fatigued, absolutely no energy and completely worn out. I have issues with blood circulation on the left side of my body and I had fluid rentention on my torso and my face. The swelling lasted for 10 days. I still have some swelling but not as bad as before. I do wear compression socks to help alleviate the swelling accumlation. I also have right side numbness on my face, foot and back. I also have difficulty talking and expressing words and getting words out. This lasted for 2 weeks. I still have this deficit and it comes and goes. It is not as bad as before. I have neck and back pain and my headaches are very bad. The pain can be measured 8/10. I did go to the ER and did run a bunch of test, labs, MRI- which came back normal. I followed up with my PCP and will be following up with neurology and pain clinic.
58 2021-07-21 numbness heart racing; started having a strange feeling in left cheek. It felt like had a dental procedure r... Read more
heart racing; started having a strange feeling in left cheek. It felt like had a dental procedure requiring numbing. The area felt warm and immediately spread to left eye and lip. It then spread around left eyebrow and down to chin.; started having a strange feeling in left cheek. It felt like had a dental procedure requiring numbing. The area felt warm and immediately spread to left eye and lip. It then spread around left eyebrow and down to chin.; high blood pressure; high pulse rate; This is a spontaneous report received from a contactable consumer (patient) via regulatory authority. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease, right hemicolectomy for colon cancer in 2019. The patient had known allergy to paracetamol (TYLENOL), clarithromycin (BIAXIN), penicillin (MANUFACTURER UNKNOWN) and fluconazole (DIFLUCAN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications received within two weeks of vaccination included lisinopril 5mg (MANUFACTURER UNKNOWN) and unspecified multivitamins. On 31Mar2021, at 10:00, the patient experienced heart racing. It felt like had a dental procedure requiring numbing. The area felt warm and immediately spread to left eye and lip. It then spread around left eyebrow and down to chin, high blood pressure, high pulse rate. Details were as follows: On 31Mar2021 at 10:00, right after getting the shot, the patient walked to a chair in the 15-minute waiting area. As soon as she sat down her heart started racing. She raised her hand and several nurses came to aid her. By the time they walked across the room to get to her, she started having a strange feeling in her left cheek. They had laid her down, she felt like she had a dental procedure requiring numbing. The area felt warm and immediately spread to her left eye and lip. It then spread around her left eyebrow and down to her chin. EMS (Emergency Medical Service) on site monitored her high blood pressure, high pulse rate, and checked her heart. The event resulted in visit to emergency room/department or urgent care. On 31Mar2021, therapeutic measures were taken as a result of adverse events; the patient had CT (Computed Tomography) scan, EKG (Electrocardiogram) and bloodwork with unknown results. The clinical outcome of all the events was resolved with sequelae in Apr2021. No follow-up attempts are needed. No further information is expected.
58 2021-07-21 migraine, burning sensation, facial pain Ear pain; Vertigo; Facial pain/freezing pain; Ear noise/Tinnitus/continuing sounds like water in rig... Read more
Ear pain; Vertigo; Facial pain/freezing pain; Ear noise/Tinnitus/continuing sounds like water in right ear; Facial pain -burning; Ear pain and noise -escalating to Migraines; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the right arm on 04Feb2021 at 07:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included numerous autoimmune issues, drug allergy (allergy to versed, codeine, morphine, cymbalta and nitrous oxide) and latex allergy. The patient received unspecified medication for unknown indications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks of vaccination. The past drug history included codeine, versed, morphine, cymbalta and nitrous oxide had taken from on unspecified date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Feb2021 at 09:00 the patient experienced ear pain, vertigo, facial pain/freezing pain, ear noise/continuing sounds like water in right ear, tinnitus, facial pain -burning and ear pain and noise -escalating to migraines. It was reported that the events had resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events included PT (physical therapy) which was ongoing and the patient was referred to specialist. On an unknown date, the patient underwent CT (computed tomography) sinus and the result was unknown. The clinical outcome of the events ear pain, tinnitus, vertigo, facial pain/freezing pain, ear noise/continuing sounds like water in right ear, facial pain -burning and ear pain and noise -escalating to migraines was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
58 2021-07-22 weakness SECOND DOSE: the same symptoms happened again (Exhausted, Very Weak, No Energy, Generally Fatigued, ... Read more
SECOND DOSE: the same symptoms happened again (Exhausted, Very Weak, No Energy, Generally Fatigued, Not Feeling Great) was reported as worsened.; SECOND DOSE: the same symptoms happened again (Exhausted, Very Weak, No Energy, Generally Fatigued, Not Feeling Great) was reported as worsened.; SECOND DOSE: the same symptoms happened again (Exhausted, Very Weak, No Energy, Generally Fatigued, Not Feeling Great); SECOND DOSE: her chest organs, primarily her lungs, felt hot or like they were on fire in her body./ also had pain in the front (chest area); SECOND DOSE: She periodically had severe back pain in the location of her lungs, and also had pain in the front (chest area); SECOND DOSE: She was having a hard time breathing; SECOND DOSE: her heart felt like it was racing; SECOND DOSE: she had a dry cough all day long; SECOND DOSE: She felt nauseous; SECOND DOSE: She felt panicked; Felt really crapy, and would have to lay down a lot; She felt so sick; Her chest felt like she couldn't catch her breath, and then it got a little worse and now it's all day long.; She had a chest infection; drug ineffective; Reported she had all COVID-y things.; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: ER8736), via an unspecified route of administration on 03Apr2021 as dose 1 single for covid-19 immunisation. Historical vaccine was BNT162B2(CONMINTARY, Solution for injection, Lot No: EU6199), via an unspecified route of administration on 06Mar2021 as dose 1 single for covid-19 immunisation. Medical history included seasonal allergy from an unknown date and unknown if ongoing She had sinus problems, and her whole life had seasonal allergies (clarified as hay fever, pet dander, and pollen). No further details provided, sinus disorder from an unknown date and unknown if ongoing She had sinus problems, and her whole life had seasonal allergies (clarified as hay fever, pet dander, and pollen). No further details provided, seasonal allergy from an unknown date and unknown if ongoing She had sinus problems, and her whole life had seasonal allergies (clarified as hay fever, pet dander, and pollen). No further details provided, allergy to animal from an unknown date and unknown if ongoing She had sinus problems, and her whole life had seasonal allergies (clarified as hay fever, pet dander, and pollen). No further details provided, seasonal allergy from an unknown date and unknown if ongoing She had sinus problems, and her whole life had seasonal allergies (clarified as hay fever, pet dander, and pollen). No further details provided, non-tobacco user from an unknown date and unknown if ongoing. There were no concomitant medications. On unspecified date in Apr2021, the patient was exhausted, very weak, no energy, generally fatigued, not feeling great) was reported as worsened, from the second dose the same symptoms happened again. On an unspecified date in 2021, the patient experienced she had a chest infection, second dose her chest organs, primarily her lungs, felt hot or like they were on fire in her body/ also had pain in the front, second dose she periodically had severe back pain in the location of her lungs, and also had pain in the front, second dose she was having a hard time breathing, second dose her heart felt like it was racing, second dose: she had a dry cough all day long, second dose: she felt nauseous, second dose: she felt panicked, felt really crapy, and would have to lay down a lot, she felt so sick, her chest felt like she couldn't catch her breath, and then it got a little worse and now it's all day long and reported she had all COVID-y things. The patient underwent lab tests and procedures which included biopsy lung: granulomas were clusters of inflamed cells on 2021, biopsy lymph gland: negative on 2021, blood test: negative on, chest x-ray: normal on Jan2020, chest x-ray abnormal: granuloma in both lungs on 2021, laboratory test normal: every test performed was negative on 2021, oxygen saturation: oxygen levels were always in the 90s on 2021 She was never short of oxygen, positron emission tomogram abnormal: lymph nodes throughout her body were "lit" on Jun2021. Therapeutic measures were taken as a result of she had a chest infection, second dose: the same symptoms happened again (exhausted, very weak, no energy, generally fatigued, not feeling great) was reported as worsened, second dose: the same symptoms happened again (exhausted, very weak, no energy, generally fatigued, not feeling great) was reported as worsened, second dose: the same symptoms happened again (exhausted, very weak, no energy, generally fatigued, not feeling great), second dose: her chest organs, primarily her lungs, felt hot or like they were on fire in her body./ also had pain in the front, second dose: she periodically had severe back pain in the location of her lungs, and also had pain in the front, second dose: she was having a hard time breathing, second dose: her heart felt like it was racing, second dose: she had a dry cough all day long, second dose: she felt nauseous, second dose: she felt panicked, she felt so sick, her chest felt like she couldn't catch her breath, and then it got a little worse and now it's all day long. Patient stated she wanted to report many adverse reactions she had to the COVID-19 Vaccine and reported her adverse reactions to the CDC a couple months ago through VAERS and HCP declined to provide reported she had her first COVID-19 Vaccine dose in Apr2021 and approximately 6 weeks later had her second COVID-19 Vaccine dose in May2021. Reported she didn't have a typical reaction to the COVID-19 Vaccine. After her first COVID-19 Vaccine dose, she was exhausted for an entire week. She felt very weak, had no energy, and generally felt fatigued and was not feeling great for about 7-10 days. She recuperated from her first COVID-19 Vaccine dose. She got the second COVID-19 Vaccine dose, and the same symptoms happened again. She didn't get a fever after either vaccine dose, but felt really crapy, and would have to lay down a lot. She said she normally walked every day and was the type of person who was always busy doing something. She said it was not normal for her to have to lay down. Reported after her second COVID-19 Vaccine, she had a chest infection, and a cough that wouldn't go away. She went to an Urgent Care for her cough. She said the healthcare provider at the Urgent Care was not sure what was going on and sent her to a pulmonologist. Treatment was the pulmonologist prescribed antibiotics (she clarified she did not know the name of the antibiotics, nor have the NDC, Lot, and Expiry Date), and ordered a chest x-ray. The chest x-ray showed her lungs were peppered with granuloma. She said she never smoked, and no one in her family ever had that type of cancer. She had a chest x-ray in Jan2020 that was normal, clarifying the chest x-ray showing the granuloma in her lungs was done in late May2021 or early Jun2021. The pulmonologist first told her the recent chest x-ray results were nothing big, but then the pulmonologist said the radiologist (who read her chest x-ray) was very concerned, and suggested she have a PET Scan. Her PET Scan showed all her lymph nodes throughout her body, but primarily in her thorax, were Lit. Reported she felt so sick, and was having a hard time breathing, but when she checked her oxygen with a pulse oximeter, she was never short of oxygen. She clarified her oxygen levels were always in the 90s. She felt like she had smog in her lungs while swimming in a pool. She felt like she had a hard time catching her breath and had to sit down. Reported she was putting everything together now. She didn't know what was going on at first. Reported the pulmonologist ran every test that could be ran, and all the tests were negative. No further details provided. Reported the pulmonologist wanted to do a bronchoscopy, and a lavage in her oesophagus. She said she never had a bronchoscopy and lavage done before. She had a biopsy of her lung granulomas, and the biopsy showed the granulomas were clusters of inflamed cells. The pulmonologist took a biopsy of some lymph nodes, and the biopsies were all negative for cancer. Reported she constantly felt sicker, and her chest organs, primarily her lungs, felt hot or like they were on fire in her body. She periodically had severe back pain in the location of her lungs, and also had pain in the front (chest area). Reported she was highly emotional now because she felt like she was getting better than wasn't and was now stayed at not getting better. Reported she had a new pulmonologist who prescribed Hydroxychloroquine. She said she didn't know the Hydroxychloroquine NDC, Lot and Expiry Date. She clarified her new pulmonologist told her the Hydroxychloroquine would take a little time to work, and the Hydroxychloroquine make take 2 weeks to 2 months to work. Reported she had all COVID-y things. She said her cough hadn't gone away, though the cough periodically stopped. She clarified she had a dry cough all day long. She felt nauseous, and her chest hurt. She has to lay down before she goes to work, otherwise, she didn't know if she could go to work. She said she never had anything like this in her life. Reported she went to the Emergency Room after she had seen the first pulmonologist because her heart felt like it was racing. She said her body had to work really hard now. She said her lungs are working harder and making her heart work harder. No further details provided. Reported she was seeing a thoracic surgeon to evaluate her lymph nodes, and possibly have another biopsy of the lymph nodes in her chest/axillary area. No further details provided. Reported she was left now with a lot of opinions and had to wait to see if the Hydroxychloroquine worked, and what the thoracic surgeon says. Reported she felt panicked. She said she doesn't know how long she can take feeling that sick, and not be treated. Reported she was not overweight, and walked miles a day, and was always moving. She said her kids have asked her why she was always tired now, and why she was not up and moving around. Reported at first, her chest felt like she couldn't catch her breath, and then it got a little worse, and now it's all day long. Reported with the Hydroxychloroquine she would have 2 great days, and then 3 bad days. No further details provided. Reported there was a lot of crying going on at her house now. Reported the doctors couldn't find anything, other than her PET Scan lit up, and the doctors don't know why. Every blood test, and possible scenario were all negative. She doesn't have an autoimmune disease, and no known conditions or diseases. The outcome of events from second dose the same symptoms happened again (exhausted, very weak, no energy, generally fatigued, not feeling great), from the second dose the same symptoms happened again, and her chest felt like she could not catch her breath, and then it got a little worse and now it was all day long and second dose she was having a hard time breathing and second dose: she had a dry cough all day long was not resolved. The outcome of the events a chest infection, second dose her chest organs, primarily her lungs, felt hot or like they were on fire in her body/ also had pain in the front, second dose she periodically had severe back pain in the location of her lungs, and also had pain in the front, second dose her heart felt like it was racing, second dose: she felt nauseous, second dose: she felt panicked, felt really crapy, and would have to lay down a lot, she felt so sick and reported she had all COVID things was unknown. Follow-up attempts are completed. No further information is expected
58 2021-07-22 weakness she was exhausted for an entire week/She generally felt fatigued; She felt very weak/ She had no ene... Read more
she was exhausted for an entire week/She generally felt fatigued; She felt very weak/ She had no energy; She was not feeling great for about 7-10 days; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EU6199, Expiry date: not reported), via an unspecified route of administration on 06Mar2021 (age at the time of vaccination was 58-year-old) as single dose for COVID-19 immunisation. The patient's medical history included seasonal allergy from an unknown date and unknown if ongoing , sinus disorder from an unknown date and unknown if ongoing , hay fever, pet dander and pollen allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not administer any other vaccines on same date of Pfizer vaccine and did not receive any other vaccinations within 4 weeks of Pfizer vaccination. On an unknown date in Mar2021, after the first vaccination the patient was exhausted for an entire week. The patient felt very weak, had no energy, and generally felt fatigued and was not feeling great for about 7-10 days. The patient recuperated from her first COVID-19 Vaccine dose. The patient received a corrective therapy for all the events. The patient visited emergency room/ physician office visit due to the events. The patient underwent lab tests and procedures which included chest x-ray and result was normal on an unknown date Jan2020, oxygen saturation: always in the 90s on an unknown date in 2021. The outcome of all events was recovered on an unknown date in 2021.
58 2021-07-22 bell's palsy Bell's Palsy; This is a spontaneous report from a contactable consumer (reported for herself). A 58-... Read more
Bell's Palsy; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0177), dose 2 via an unspecified route of administration, administered in arm left on 19Apr2021 at 17:00 (at the age of 58-years-old) as dose 2, single for covid-19 immunization at Pharmacy or Drug Store. Medical history included ongoing blood cholesterol and ongoing nephropathy. The patient did not receive any other vaccines within four weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Device Date was reported as 11Jul2021.Concomitant medication within 2 weeks of vaccination included rosuvastatin (ROSUVASTATIN). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162), dose 1 via an unspecified route of administration, administered in arm left on 19Apr2021 at 17:00 (at the age of 58-years-old) as dose 1, single for covid-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 05Jul2021 at 09:00, the patient experienced bell's palsy. The case assessed as serious (Disabling/Incapacitating, medically significant). There was no Prolonged hospitalization. The adverse event result in Emergency room/department or urgent care. Therapeutic measures were taken as a result of event and treatment included with Prednisone, Valacyclovir and Systane. The outcome of the event was not resolved. Follow-up attempts are completed. No further information is expected.
58 2021-07-22 hot flush Post menopausal hot flashes every day; Post menopausal hot flashes every day; This is a spontaneous ... Read more
Post menopausal hot flashes every day; Post menopausal hot flashes every day; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 59-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731, Expiration date not reported), via intramuscular in right arm on 13Apr2021 14:45 (at the age of 58-year-old) as single dose for COVID-19 immunization at hospital. The patient medical history included: high blood pressure and thyroid from an unknown date and unknown if ongoing. The patient was allergic to stone fruit. The patient concomitant medication included thyroid (ARMOUR THYROID), metoprolol tartrate (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL [IBUPROFEN]). The patient previously received codeine and experienced allergy on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported as unknown whether the patient had COVID prior vaccination. The patient was not COVID tested post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number ER8727, Expiration date not reported), via unspecified route of administration in right arm on 23Mar2021 14:45 (at the age of 58-year-old) as single dose for COVID-19 immunization. On 20Apr2021 16:30, the patient experienced Post-menopausal hot flashes every day. The patient did not receive any treatment for the event. The outcome of event was not resolved. Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.
58 2021-07-22 nerve pain, weakness, nerve injury, tingling Severe pain in all of my joints/ all over my joints down to my toes are probably sore; didn't feel g... Read more
Severe pain in all of my joints/ all over my joints down to my toes are probably sore; didn't feel good and went to sleep; I have like some nerve pain, started in my, is like tingly; like nervy on my right. I don't know, if it's connected or not on my right arch of my foot,; I just felt 'lack' of any energy; My back feels like every nerve is on fire, there is electricity; my rib and the front of my upper abdomen and all over my joints down to my toes are probably sore; my rib and the front of my upper abdomen and all over my joints down to my toes are probably sore; I am so agitated; Fatigue; My back feels like every nerve is on fire, there is electricity; Severe headache; Stiff neck; This is a spontaneous report from a contactable other health care professional (nurse). A 58-year-old female patient (nurse) received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in left upper arm on 07Jul2021 11:00 (at the age of 58-year-old), as Dose 1, single for Covid-19 immunization. Medical history included the patient had shingles a long time ago. Patient did not report any other medical conditions. The patient did not receive any other vaccine in four weeks prior to vaccination. Concomitant medications included Trazodone; Cymbalta; atorvastatin (LIPITOR [ATORVASTATIN]) (referred as generic cholesterol medicine); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and coffea canephora (ZENAC), mild daily. On 07Jul2021 patient had first shot at about 11 o'clock and within hour she just felt lack of any energy and was started getting massive/severe headache and stiff neck, severe pain in all of my joints but also my back feels like every nerve were on fire, there is electricity (serious as medically significant event), the back of her left side of her head and neck and just feeling a lot of fatigue. Patient came home and got in bed, she took two Tylenol 1000 milligrams at 3 o'clock (Intent: treatment) and went to bed and she immediately went to sleep and slept for 4 hours straight. She thought what woke her up like her back was on fire and for some reason, she felt very agitated (patient did not mean to be personally agitated to anybody) that she could not stand it and that was not her. The patient further stated, "severe pain in all of my joints, I can't stand it and that's not me, didn't feel good and went to sleep, all over my joints down to my toes are probably sore; on an unspecified date, she stated that "I have like some nerve pain, started in my, is like tingly, like nervy on my right and she don't know, if it's connected or not on my right arch of my foot". When probed for the permission to ask further questions, Nurse stated, "That's okay because like I said like is it normal and my back is on fire, I just feel very agitated and I don't know why, I just woke up that way. I don't usually feel that way, so I don't mean to be personally agitated to anybody, you see what I mean." When probed for clarification if consumer wants to know the side effects are normal, Nurse stated, "Well, I am just reporting. I don't think, it might be, it might not be. I don't know but I just wanted to report it because in all the literature, it doesn't say anything about it." The patient received treatment for events Headache, stiff neck, nerve pain in back and joints to upper abdomen, fatigue, with Tylenol, 1000 milligrams. Causality for the events "My back feels like a campfire like the nerve endings are electric; it's actually coming around to the like sides of my rib and the front of my upper abdomen and all over my joints down to my toes are fore ably sore; It's feels like nerve pain in my back and then in my joints to my upper abdomen; horribly agitated; 'I have like some nerve pain, started in my, tingly like, nervy on my right. I don't know if it's connected or not. on my right arch of my foot when I just got up and walk. Since I pressure on it'; and Like sides of my rib and the front of my upper abdomen and all over my joints, down to my toes are probably sore', was reported as related by the reporter. The outcome of all events was reported as unknown. Causality: Nurse stated, "Well, I would say, yeah, because I never had this. Well, I have never. Yeah, that's definitely. I just feel like my joint hurts, my muscle ache, you know, I got that weird. I had shingles a long time ago in my back and that what if feels like shingles pain in my back and then in my rib and then my head, like I said, very, I don't usually have headache and stiff neck so, yeah, I think it's as far as the foot thing. I have no idea (As the Nurse was not sure about this hence not captured in tab) but yeah." Nurse was informed about Pfizer Medical Information and telephone number was shared. ; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported event of neuralgia and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-07-22 pain in extremity, weakness slightly lack of energy.; Sore arm; a little tired; Stuffy head; This is a spontaneous report from a... Read more
slightly lack of energy.; Sore arm; a little tired; Stuffy head; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0150), via unspecified route of administration in the left arm on 02Apr2021 at 11:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient had a history of allergy to amoxicillin. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202), via unspecified route of administration in the left arm on 09Mar2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 15:00, the patient experienced sore arm, a little tired and stuffy head. On 03Apr2021, on 2nd day after the shot the patient experienced slightly lack of energy and sore arm continued. The 3rd day after the shot only sore arm was there. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events reported. The clinical outcome of the event sore arm was not recovered while the outcome of events stuffy head, a little tired and lack of energy was recovered on 04Apr2021. No follow-up attempts are needed. No further information is expected.
58 2021-07-23 pain in extremity My upper right arm still hurts. I did not have arthritis like this my hands are becoming crippled; j... Read more
My upper right arm still hurts. I did not have arthritis like this my hands are becoming crippled; joints swollen; nausea; I have on and off random unexplained fevers; second dose 02Mar2021; second dose 02Mar2021; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received bnt162b2 (PFIZER -BIONTECH COVID-19 VACCINE), dose 1 at the age of 58-year-old on 02Mar2021 (lot number: El3302) as single dose in Right arm, second dose at the age of 58-year-old 02Mar2021 (lot number: Ew6w2) as single dose Left arm, both for COVID-19 immunisation. The patient was not pregnant. No covid prior vaccination. Known allergies was No. Other medical history included Chronic back pain. No other vaccine in four weeks. No other medications in two weeks. Her upper right arm still hurts. She did not have arthritis like this her hands was becoming crippled and joints swollen. She had been nausea every single day at some point since getting the vaccine and she had on and off random unexplained fevers. Adverse event start date was 03Mar2021. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and was serious due to Disability or permanent damage. Adverse event treatment included patient was on otezla and it was not helping. There was no covid tested post vaccination. The outcome of the event was unknown.
58 2021-07-24 burning sensation Sharp pain to *temple of head,* Irradic heart BP & *Pulse * Severe Swelling of Limbs Extra On the Le... Read more
Sharp pain to *temple of head,* Irradic heart BP & *Pulse * Severe Swelling of Limbs Extra On the Left Side Arms got rash that was bumpy and would burn *Also Sternum to Waiste Water retention took weight 185 To 207 over night *** Still occurring Sweeting profusely, Temperature {My norm is 87.8} Heavy breath wheezing Mucus white crystallized/hard Nebulizer air pro inhailet high 101.8 & very low 94° Dehydration Diarrhea stomach cramps chills
58 2021-07-24 discomfort Patient woke up 07/24/21 morning complaining of right eye swollen, puffy, and pink. Swelling went do... Read more
Patient woke up 07/24/21 morning complaining of right eye swollen, puffy, and pink. Swelling went down by 2pm, but orbital area remains very sore, with complaint of "achy eyeball". Patient has used ice packs to reduce swelling and relieve discomfort. Patient reports slight discoloration between right eye and nose. Patient reports left eye is a little sore, but not as bad as the right eye.
58 2021-07-24 tingling Within 15 min of the injection. I had a few welt hives on the right fore arm. Tingling in the face, ... Read more
Within 15 min of the injection. I had a few welt hives on the right fore arm. Tingling in the face, lips, arms, After 30 minutes same feelings, drank water. After 30 -45 minutes noticed two nodule circular rosea type under the skin in the left arm. and now face, and lips still tingling , Left arm a little tight. More welt-type hives on the right arm so took benadryl. Lips tight and forehead itching and back. Drank more water. At home , applied cold towels to injection site and welt hives. Took cool shower and more benadryl and water. Went to pharmacy to ask if anything else will help. WIthin 12-16 hours drank 32 ounces of water and 3 teaspoons of benadryl..Between 16-24 hours taking another 2 teaspoons of benaryl and 32 to 64 ounces of water and trued range of motion exercies due to stiffness of joints and tightness of hands, back, neck, arms adn joints.
58 2021-07-25 numbness Pt. states that after receiving the 1st dose of Phizer 03/10/2021, started experiencing symptoms 03/... Read more
Pt. states that after receiving the 1st dose of Phizer 03/10/2021, started experiencing symptoms 03/10/2021 of Numbness/tingling in the side of the head 3 weeks, PCP visit advised to get the 2nd shot, Neurologist visit Cat Scan preformed states that maybe have symptoms of nerve damage.
58 2021-07-25 pain in extremity, migraine Severe migraine , full body joint /bone pain, extreme fatigue, Chills so severe resembled causing ... Read more
Severe migraine , full body joint /bone pain, extreme fatigue, Chills so severe resembled causing strong shivering. Chills followed by severe sweating . Unable to sleep due to these symptoms . Had intermittent episodes of lightheaded ness . Loose stooling . No appetite . These symptoms went on for 3days starting morning of day after vaccine . The left arm was also very painful for 5 days . Temperature at highest point 100.8. Pre-treated prior to vaccine with Claritin took 2 hrs prior because of history with reaction to flu vaccine years ago from multi vial . Treated chills with Tylenol 325mg as needed. Took Ibuprofen prn for joint pain. Treated migraine with 1dose of Excedrin which did not take the headache away.
58 2021-07-26 difficulty speaking My vocal chord on left side is paralyzed. I became hoarse about a week after vaccine and went to Dr... Read more
My vocal chord on left side is paralyzed. I became hoarse about a week after vaccine and went to Dr a month later when voice had not returned.
58 2021-07-27 bell's palsy bell's palsey; headache returned; This is a spontaneous report from a contactable consumer (patient)... Read more
bell's palsey; headache returned; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient (not pregnant) received bnt162b2 (Pfizer, Batch/Lot Number: EW0173), second dose via an unspecified route of administration, administered in left arm on 22May2021 at the age of 58-year-old as dose 2, single for covid-19 immunization. Medical history included Hodgkins Lymphoma from an unknown date and unknown if ongoing. The patient previously took morphine and experienced allergies, first dose of bnt162b2 (Pfizer, Batch/Lot Number: EW0172) via an unspecified route, administered in left arm on 01May2021 at the age of 58-year-old for covid-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included: WOMEN'S ONE A DAY OVER 50. The patient experienced bell's palsey on 08Jun2021, headache returned/ headache on 23May2021. Onset of headache was 23May2021 which lasted until 27May2021 in back of head. Headache returned 03Jun2021 with no relief, so she went to the emergency department on 08Jun2021 and was diagnosed with bell's palsey. No prior history of nerological issues or disorders. Medication was provided and symptoms of bell's palsey went away by 22Jun2021. The event resulted in emergency room/department or urgent care visit. Therapeutic measures were taken as a result of events included empiric valacyclovir and prednisone, eye patching. The case was reported as non-serious. The outcome of events was resolved on 22Jun2021. Facility where the most recent COVID-19 vaccine was administered was hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
58 2021-07-27 feeling of insects crawling on skin Severe Anxiety after second; feeling of eyes dilated; nausea; worse confusion; head crawling; head p... Read more
Severe Anxiety after second; feeling of eyes dilated; nausea; worse confusion; head crawling; head pain; havent been able to sneeze after second; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0153) dose 2 via an unspecified route of administration in right arm on 07Apr2021 at 10:00 (at the age of 58-year-old) as single dose for COVID-19 immunization. Medical history included Hepatitis B inactive, Hepatitis C cured, Genital Herpes, gastroparesis, IBS/ Irritable bowel syndrome, arthritis, allergies to steroids, Codene. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol, omeprazole, alprazolam (XANAX), macrogol 3350 (PEG3350), all in two weeks. No other vaccine received in four weeks. The patient previously took ciprofloxacin and had allergy. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8732) dose 1 in right arm on an unspecified date as single dose for Covid-19 immunization and experienced anxiety week after first, confusion, sweat. On 13Apr2021 at 07:00AM, the patient had severe anxiety after second, feeling of eyes dilated, nausea, worse confusion, head crawling, head pain, still having side effects. It always started a week later. She was having MRI and MRA done this Friday. Didn't realize till after second shot, it was all from vaccine, thought she was having other problems, but now know it was from vaccine after second wave of side effects, hit her like a freight train all at once. Also haven't been able to sneeze after second, had to several times, but was not able to do it anymore. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if received treatment for events. The outcome of events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
58 2021-07-27 night sweats Headache; Night sweats; Swollen lymph node in armpit; Mild all over body itching; This is a spontane... Read more
Headache; Night sweats; Swollen lymph node in armpit; Mild all over body itching; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 11Mar2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN SR), calcium (MANUFACTURER UNKNOWN), vitamin b 12 (MANUFACTURER UNKNOWN) and vit D (MANUFACTURER UNKNOWN) all for unknown indication, from unknown date within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. In Mar2021, the patient experienced headache, night sweats, swollen lymph node, armpit and mild all over body itching. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, night sweats, swollen lymph node, armpit and itching all over body were recovered. No follow-up attempts are needed. No further information is expected.
58 2021-07-27 pain in extremity Several weeks after the second shot I experienced severe, radiating pain in my legs at night. The lo... Read more
Several weeks after the second shot I experienced severe, radiating pain in my legs at night. The location of the pain varied. It moved from my knee to thigh to calf, and affected both legs at different times. The pain has continued, but gotten less severe and less often. It seems to be exacerbated by exercise. It's both joint pain and muscle/soft tissue pain.
58 2021-07-27 tingling, cold extremities, pain in extremity States on the third day, Sunday 07Feb2021, things got worse; woke up with vaginal spotting, does not... Read more
States on the third day, Sunday 07Feb2021, things got worse; woke up with vaginal spotting, does not menstruate anymore, never spotted before, just in morning when she woke up; Excruciating hip and butt pain on left side, if it sat she hurt, if it stood it hurt; felt sick; pain in her arm then it started radiating down her arm into hand, it felt cold and tingly; hives on chest, left arm, and left palm; Was tired that night; pain in her arm then it started radiating down her arm into hand, it felt cold and tingly; pain in her arm then it started radiating down her arm into hand, it felt cold and tingly; on the same day, did not feel good/still felt so bad on the left side that she went to urgent care; rapid heart rate; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 58-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 05Feb2021 14:00 (age at vaccination: 58-years-old) as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that she had her first dose of Pfizer Covid vaccine 05Feb2021, had so many side effects. Got injection around 14:00 on 05Feb2021, was fine at first, after about 15 minutes she had some pain in her arm then it started radiating down her arm into hand, it felt cold and tingly. she stayed there being monitored for 20 minutes after the vaccine. Stated on the way home in the car on the same day, did not feel good, felt sick, rapid heart rate, hives on chest, left arm, and left palm. Took 2 Benadryl at this time. States she had no problem breathing. Was tired that night and went to bed, next day just some more pain in the arm and tired. States on the third day, Sunday 07Feb2021, things got worse, woke up with vaginal spotting, does not menstruate anymore, never spotted before, just in morning when she woke up. Excruciating hip and butt pain on left side, if it sat she hurt, if it stood it hurt. Treated with Advil, drinking water, alternating heating pad and ice. Doctor ran blood work, it was normal. Saw allergist on Friday, still felt so bad on the left side that she went to urgent care, got tested for Covid, it was negative, told her to follow up with a neurologist. did PEG testing at allergist, not allergic to components of vaccine. Doctor suggested her body having a strong immune reaction to the vaccine, that it was her body reacting to the vaccine. she is due for her second shot tomorrow, 23Feb2021, is scared to get it. If she did decide to get it how long does she have to get it. The patient underwent lab tests and procedures which included blood test: normal, heart rate: rapid on 05Feb2021, sars-cov-2 test: negative, skin test: unknown results (did PEG testing at allergist, not allergic to components of vaccine. Doctor suggested her body having a strong immune reaction to the vaccine, that it was her body reacting to the vaccine). Therapeutic measures were taken as a result of hives on chest, left arm, and left palm, excruciating hip and butt pain on left side, if it sat she hurt, if it stood it hurt. The outcome for the event pain in her arm was not resolved and for rapid heart rate resolved on 05Feb2021, hives on chest, left arm, and left palm resolved on 06Feb2021, woke up with vaginal spotting, does not menstruate anymore, never spotted before resolved on 07Feb2021, just in morning when she woke up, excruciating hip and butt pain on left side, if it sat she hurt, if it stood it hurt the outcome was resolved on 22Feb2021 and for remaining events outcome was reported as unknown. No follow-up attempts are possible. No further information is expected.
58 2021-07-27 tingling upper lip felt numb; Upper lip felt tingling; bitter/metallic taste; Nausea; Loss of appetite; Tingl... Read more
upper lip felt numb; Upper lip felt tingling; bitter/metallic taste; Nausea; Loss of appetite; Tingling legs; Heart racing; Chest tightness; Light headedness and dizziness; chills and trembling (felt like low circulation); Overall exhaustion; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8743), via an unspecified route of administration in the left arm on 03Apr2021 at 17:45 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8743) as a single dose for COVID-19 immunisation. Medical history included iodine allergy and allergy to melons. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN) and vitamins (MANUFACTURER UNKNOWN); both taken for unspecified indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took epinephrine (MANUFACTURER UNKNOWN) on unknown dates for an unknown indication and experienced drug allergy. On 03Apr2021 at 17:55, the patient experienced tingling legs, heart racing, chest tightness, light headedness and dizziness, and chills and trembling (felt like low circulation). On 03Apr2021 at 18:05, the patient experienced upper lip felt numb, upper lip felt tingling, bitter/metallic taste, nausea, and loss of appetite. After this on 03Apr2021, the patient had overall exhaustion. The patient did not receive any treatment for the events. The clinical outcomes of tingling legs, heart racing, chest tightness, light headedness and dizziness, and chills and trembling (felt like low circulation), upper lip felt numb, upper lip felt tingling, bitter/metallic taste, nausea, and loss of appetite, and fatigue, was recovered on unknown dates in Apr2021. No follow-up attempts are required. No further information is expected.
58 2021-07-27 tingling Vertigo; Tingling in face, neck and arm; Pain around left ear; This is a spontaneous report from a c... Read more
Vertigo; Tingling in face, neck and arm; Pain around left ear; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ;Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 25Mar2021 at 08:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 04:00, the patient experienced vertigo, tingling in face, neck and left arm, and pain around left ear. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vertigo, tingling in face, neck and left arm, and pain around left ear was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
58 2021-07-27 tenderness Chills; Fever; Extreme tiredness; Nausea; Swelling; Extreme tenderness; Slight pain under left armpi... Read more
Chills; Fever; Extreme tiredness; Nausea; Swelling; Extreme tenderness; Slight pain under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 30Mar2021 at 15:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to aluminium when used as a preservative for an injection. Concomitant medications included vit B12 (MANUFACTURER UKNOWN), vit D (MANUFACTURER UKNOWN) and fiber. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 15:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, approximately 18 hours after second vaccine the patient experienced chills, fever, extreme tiredness and nausea. On 31Mar2021, approximately 24 hours after second vaccine the patient experienced swelling, extreme tenderness and slight pain under left armpit. After about two days, the patient did not experience symptoms any longer. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events chills, fever, extreme tiredness, nausea, swelling, extreme tenderness and slight pain under left armpit was resolved on 02Apr2021. No follow-up attempts are needed. No further information is expected.
58 2021-07-27 tremor, weakness, tingling later that day blood pressure rose to 196/110/Again it Escalated the following day; body aches; head... Read more
later that day blood pressure rose to 196/110/Again it Escalated the following day; body aches; headache; interment weakness; shaking in my arms; tingling sensation in my feet and lower legs; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in right arm on 14Mar2021 16:00 (Batch/Lot Number: EP6955) (at the age of 58-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not diagnosed with covid-19 prior to vaccination. Medical history included allergies to Nyquil and wasp. Concomitant medications included ademetionine (SAM-E); colecalciferol (D3); elderberry [sambucus nigra]; and magnesium carbonate (MAG 2 [MAGNESIUM CARBONATE]). On 15Mar2021 at 05:00 PM, the patient experienced later that day blood pressure rose to 196/110, body aches, headache, interment weakness, "shaking in my arms," and "tingling sensation in my feet and lower legs." It was further reported that the blood pressure rose to 196/110 and came down that night and again it escalated the following day and went to emergency room (ER) and was treated with blood pressure medication. The events resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure increased: 196/110 mmhg on 15Mar2021 and sars-cov-2 test (nasal swab): negative on 16Mar2021. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events. Follow-up attempts are completed. No further information is expected.
58 2021-07-28 numbness, feeling cold injection site is red,it is painful; a little warm to the touch; feels "tight", and she can feel a s... Read more
injection site is red,it is painful; a little warm to the touch; feels "tight", and she can feel a small knot in the area where the shot was given; some body aches; injection site is red,; chillness on her body; cold; Her whole body doesn't feel normal and uncomfortable; It is little numb; Tightness is on her neck; This is a spontaneous report from a contactable consumer. This 58-year-old (age at vaccination) female consumer with weight; 90.72 kg, height; 168 cm reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number; unknown, Reason for no lot number: of COVID-19 Vaccine: Other: Either EL9266 or EL9244. Handwriting on record card is hard to read, COVID-19 Vaccine manufacturer: Unspecified, NDC number, expiry date; unknown) via an unspecified route of administration on 19Feb2021 in right arm as dose 1 , single for covid-19 immunisation. Patient's medical history included Covid -19, breast cancer (dates unspecified). She only takes one kind of medication. Had breast cancer nine years ago. She takes vitamins. Concomitant medications included ANASTROZOLE via an unspecified route of administration from an unspecified date to an unspecified date at 1 mg once a day for an unknown indication. Consumer who received her first dose of Pfizer-Biontech Covid19 vaccine 19Feb2021. She has since reported that the injection site is red, a little warm to the touch, feels "tight", and she can feel a small knot in the area where the shot was given, and some body aches. She did not use any medication to treat her symptoms. She also reports the red area has grown, it was the size of a quarter, yesterday, and is now bigger. She reported that a number of her friends (85%) had no reaction after the first dose, but they did get a reaction after the second dose. Since she's having a reaction after the first dose, should she expect a worse reaction after the second dose. Had Covid19 virus 1.5-2 months ago- affect her vaccine. She also reports having a Sars-Cov-2 infection 1.5-2 months ago. Will this affect her vaccination. Patient got the COVID-19 Vaccine about three days ago. Area on the injection is kind of red and a little warm. Asked if this is normal. Injection area is a little pinkish about the size of two quarters. When she puts her hand on the injection area, she can still feel the tightness and it is painful. Does not hurt very much, but she can see the tightness. She got the COVID-19 virus a month and a half to two months ago. Wants to know if this would have any effect on the COVID-19 Vaccine. She could feel the chillness on her body when she got the COVID-19 Vaccine. It is not very serious, but she felt a little cold. She doesn't worry about coldness. Her whole body doesn't feel normal and uncomfortable. She won't say it's muscle pain. She cannot say what specific body part it is, she feels uncomfortable everywhere. And feels tight on that area. Confirmed this occurred after her first dose of the COVID-19 Vaccine. Doesn't feel the chillness in her body today. Her body is much better than the second day in regards to the tightness. On the injection area, it is still kind of pink. Wants to make sure it is not going to hurt her and she is ok. Injection area is red and a little warm: She had the sticker on her injection site. The first day she did not take off the sticker, but knew it was kind of pink. Thought the sticker was irritating her so she took it off. Saw the tightness and pink at the injection area. It is a little numb. Is warm, but not hot. It is not as big as today. Injection area looks smashed and bigger, about two quarter sizes. Uncomfortable: Occurred on second day and only lasted for one day. She has no chill at all. Is having body aches. Can't tell the ache apart from the tightness. Tightness is on her neck and doesn't know if she didn't sleep well. Just happened a couple of days. COVID-19 Vaccine: Provided either EL9266 or EL9244. Stated the 6 also looks like an 8. Stated it could also be EL92UU. She doesn't know. Grabbed her mother's COVID-19 Vaccine patient record card to compare lot numbers. Both consumer and her mom received the COVID-19 Vaccine at the same place and time. Consumer is unable to read her mother's lot number from the patient record card. No further details provided. Consumer goes back for second dose on 12Mar2021. Indication: Wants to be safe in the future. Her mom is 80 years old and lives with the consumer. Consumer works in restaurant business and doesn't want to bring anything home. Consumer got COVID-19 Virus a month or two ago. It was a pain and doesn't want to bring that to the house. Consumer and her mother both decided to take the COVID-19 Vaccine. Investigation assessment; unknown. The outcome of event vaccination site pain and vaccination site warmth, vaccination site erythema, feeling cold, numbness was unknown, vaccination site mass was recovering, pain was not recovered, chills, feeling abnormal and neck discomfort was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
58 2021-07-28 pain in extremity Aching body; Head ache; Nausea; Sore arm; Very tired; This is a spontaneous report from a contactabl... Read more
Aching body; Head ache; Nausea; Sore arm; Very tired; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Er8734) via an unspecified route of administration in the right arm on 05Apr2021 at 12:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, arthritis, Gastroesophageal reflux disease (GERD) and covid-19. The patient had no known allergies. Concomitant medications included esomeprazole magnesium (MANUFACTURER UNKNOWN), vaccinium macrocarpon (CRANBERRY EXTRACT) and calcium (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 13:00, the patient experienced head ache, nausea, aching body, sore arm and very tired. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the events. The clinical outcome of the events head ache, nausea, aching body, sore arm and very tired were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
58 2021-07-28 tingling, pain in extremity, numbness Numbness in hands; Tingling in hands; Pain in right arm; This is a spontaneous report from a contact... Read more
Numbness in hands; Tingling in hands; Pain in right arm; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021 at 10:30 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder and connective tissue disease. The patient reported of no known allergies to medications, food, or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), sertraline (MANUFACTURER UNKNOWN) and statin (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient experienced numbness and tingling in hands, pain in right arm. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events numbness and tingling in hands, pain in right arm was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
58 2021-07-29 weakness body hurting/body hurts/body aches; can hardly walk; weakness; swollen arm/; Swollen arm where the i... Read more
body hurting/body hurts/body aches; can hardly walk; weakness; swollen arm/; Swollen arm where the injection was given; This is a spontaneous report from a contactable consumer (patient herself). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA7485), via an unspecified route of administration, administered in left arm on 13Jul2021 (age at vaccination: 58 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included covid-19, ongoing diabetes mellitus, sinusitis, thyroiditis and pain. Concomitant medication(s) included topiramate (has been on for a couple of years) taken for headache; gabapentin (has been on for a few years); levothyroxine sodium (THYROXINE) (has been on for a couple of years) taken for thyroiditis; estradiol; montelukast sodium (SINGULAIR) 10mg taken for sinusitis; pravastatin; metformin 500mg taken for diabetes mellitus and hydrocodone taken for pain in her back and down her legs. On 13Jul2021, the patient's body was hurting/body hurts/body aches, can hardly walk, weakness, swollen arm where the injection was given which started yesterday evening and has gone down some since she soaked it. The patient stated that body pain started last night, or actually yesterday when she was at work; weakness started yesterday evening, it was about the same and has not gotten better. There was no treatment was given for the adverse events. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room and physician's office. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unknown date. The outcome of the event pain, gait disturbance, asthenia, was not recovered; peripheral swelling, vaccination site pain was recovering. There was no product quality complaint (PQC) present.
58 2021-07-29 migraine, numbness had heavy breathing/shortness of breath; itching/ hands and feet were red and itchy; and a rash on h... Read more
had heavy breathing/shortness of breath; itching/ hands and feet were red and itchy; and a rash on her hands and feet/ hands and feet were red and itchy; lethargy; migraines; body aches; hives on her face/ face and neck she had welts; numbness on her face, hands, lips and feet/ numbness in her face lips and tongue; numbness on her face, hands, lips and feet; This is a spontaneous report from a contactable consumer reporting for self, via the Pfizer-sponsored program. A 58-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration in left shoulder on 14Jul2021 (Batch/Lot Number: ER8731) as a single dose for COVID-19 immunization. Medical history included allergic to insect bites, shellfish, and she had COVID in Mar2020. Concomitant medication(s) were none. There were no vaccinations in the 4 weeks prior. The patient previously took epinephrine (EPIPEN) for severe allergic reaction and pneumonia vaccine on 23May2020 (at age 57 years old) and experienced migraines. The patient reported she had many side effects after her first dose such as numbness, itching, migraines, body aches, lethargy, hives on her face, and a rash on her hands and feet. She had the numbness on her face, hands, lips and feet started immediately after administering the vaccine (14Jul2021). She took Tylenol so it wouldn't get worse and she took Benadryl because her hands and feet were red and she also experienced body aches (onset 14Jul2021). She states she has an EPIPEN she carries just in case of a severe allergic reaction because she was allergic to insect bites, shellfish, and things like that, but she did not use it after she received the vaccine. She only took Benadryl. She also had heavy breathing/shortness of breath as a symptom. On her face and neck she had welts and she didn't see the rest of her body because she had pajamas on. When she got up to use the restroom she was trying to figure out why she was itching. She saw welts on her face and neck. Her hands and feet were red and itchy. There was no investigation assessment. At the time of the report, the numbness in her face lips and tongue was gone (recovered in Jul2021) but the numbness in feet and hands remain (not recovered). There was no treatment for this event. The welts on her face and neck had started 30 mins after she departed got in the car and went home, and had gone away on 14Jul2021, after Benadryl (recovered). The migraines had started about 6pm on 14Jul2021; they were dulling and were going away, but was still on the back of the head. It was persisting (not recovered). Treatment for the migraines was just the Tylenol. The body aches were treated with Tylenol and were ongoing (not recovered). The events did not require a visit to the Emergency Room or Physician's office. She wanted to know when these symptoms would go away .If she takes dose 2, she wanted to know what can she do as preparation for this because she heard the second one is worse.
59 2020-12-31 weakness High injection site left deltoid resulted in moderately severe left shoulder joint pain, weakness a... Read more
High injection site left deltoid resulted in moderately severe left shoulder joint pain, weakness and reduced range of motion causing reduced ADLs for 10+ days
59 2020-12-31 tingling, numbness DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE... Read more
DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE FEELS FINE 20MINS AFTER THE EVENT.
59 2021-01-01 pain in extremity Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore a... Read more
Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore arms, fatigue then started getting brain fog , HA, body aches until current. my MD and I thought it was due to vaccine. Then add loss of taste and appetite on 12/30/20 along with rest of symptoms. I knew then I needed to get swab. Symptoms is still current.
59 2021-01-01 pain in extremity I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 h... Read more
I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 hours I felt soreness at a level of 2-3/10 at the injection site. Starting at - 19:00 the pain radiated down toward my elbow and up into my neck and base of skull. The soreness in my neck and base of skull was at a lever of 4/10. By 12/24/20 at approximately 18:00 the side effects had dissipated.
59 2021-01-03 numbness, tingling Half an hour after receiving vaccine in left arm, my left face started with a tingling, numb feeling... Read more
Half an hour after receiving vaccine in left arm, my left face started with a tingling, numb feeling like when you get anesthesia from a dental procedure and it is thawing out. It was just the left side of my face, same side I got the vaccine. Could feel a dividing line in the middle of my face. It lasted with the same intensity for 3 days. It then started to subside slowly for the next 3 days and then was totally gone.
59 2021-01-03 numbness I experienced numbness of my chin and lips. Also, I had stiffness of my jaws. I was given a Zetec (a... Read more
I experienced numbness of my chin and lips. Also, I had stiffness of my jaws. I was given a Zetec (allergy Tablet PO) and monitored for 1 hour, with vital signs being taken.
59 2021-01-04 discomfort Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and sh... Read more
Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and she got the head cold in Dec2020; little whooping cough; I had severe headaches and it was just too uncomfortable; my head was so congested; worst headache; it was just too uncomfortable; This is a spontaneous report from a contactable consumer(patient). A 59-year-old female patient received BNT162B2 via an unspecified route of administration on 22Dec2020 at the 59-year-old at single dose for Covid virus. The medical history included Congested, head cold and Covid virus. There was no concomitant medication. The patient work at a hospital and she went for a Covid shot (clarified as Covid 19 vaccine) on 22Dec2020 and she got a very bad reaction from it which bothered her, she had severe headaches in Dec2020 and it was just too uncomfortable and on 24th she was very tired, she didn't had too much of upset stomach in Dec2020 but it was not all that bad by 9 in the clock by morning she was at work and everything and she was told by if she was not feeling well she can walk by a day, but her question and her concern was back on November okay she had called in sick around, she had a funeral that she gone too and people that were at the funeral, unfortunately were smoking outside and smoke bothers me very much, she get congested and she get head cold from it you know and I was thinking it's nothing it's just a cold and somebody told her no (name) you better go get yourself to the employee health office and get checked out and she didn't bother doing that, she said no it's just the cold she will be fine but then it just got worse down the road and she said to herself may be she better just to say she did it, so she called in sick on 24th because she had the cold still and she called and she went to employee health office on 25th she still had the headache and she still had the cold, however when she went to the health office they said to her well stay out of work and we will get back in touch with her and she said okay and she will do that so when they got back in touch with her they said they do have the Covid and she said ohhh she said okay so she stayed out of work and she went to work on the 07Dec so she was wondering whole time, so her confusion was this she was told if you already had the virus in her which at that time, she did not know what it was she just thought it was from cigarette smoke because it got her all congested and she got the head cold in Dec2020 and the whole thing that went along with it and the health employee officer know you had the virus and it's just the virus and she go oh great and that's when they told her to stay out of work and she said okay fine then she just have to that, so in the meantime everybody in the work said hi calling me checking up on her and she said it's so nice of you people, she appreciate it but then she went back to work she was still feeling you know much better than she was but she had little whooping cough in Dec2020 but that was not really that bad, so they said you going to get the shot or not, and she said she don't know she kind of debatable, she don't know if she should get it, because she work in the hospital or she should not get, she said she don't know she was kind of up and some people like she get it sometime your health was not that good but on the other hand everybody that is working here in the hospital working with patients because was work right in the ICU, all over the floor you know spreading right there so she said oh alright so she kicked myself and said go get the shot, get it just over with and get it out of here so that is when she took her shot that was on 22nd and on 24th she was very tired all day no she was tired all day but she was kind of dragging most of the day but she had on the 20th no that was fine on the 20th okay for some reason she guess it was after work that week on 19th, she came home and her head was so congested and she had the worst headache and she felt like a wand had hit her over the head, it was horrible and all she could smell was cigarette smoke, like is her neighbor smoking here so she went down the hall because in live in building that used to be hotel but now they turned that into Condominium and she walk up and down the hall and she was like was somebody smoking or why this or why smell this so strong and the all the lights off in a hallway and she don't want to offend anybody but they had to go to work and somebody elsewhere and she am like she can't stand this smell and they gave this shot and she went for this shot, and they told us to come back she think it was a week or something like that to get the second shot, and she am saying if this going to cost her going to feel this way again, she don't want to get the second shot, she told them that and they told her to call this number and talk to them.The only reason she got it because they encouraged to get it. Even though she had the Covid virus, people said if you already have the virus you don't need to get a shot but people were encouraging because that's she thought well she guess she will get it. But she was mad that she got because it made her sick in Dec2020. And because we already got it they want us to go back and get the second shot and what she was m trying to say to you is, without take and hour 3 hour of conversation here she just want to say she don't want to get back and get the second shot and if it is okay by you guys somehow send her a letter or whatever it is, whoever she have to talk to because she don't want to go back and get the second shot just because of getting sick. She took Excedrin because that works for my headache. She didn't understand why you need all this information history with all this when all she want to say was she didn't want to get a second shot. The outcome of events Head cold and Headache was not recovered, the other events was unknown. Information on the lot/batch number has been requested.
59 2021-01-04 numbness, tingling Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea ... Read more
Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea and numbness and tingling in fingertips 5 minutes after administration of vaccine and proceeded to bathroom. Patient with unwitnessed vomiting prior to RN assessment. RN assessed patient and taken safely to private evaluation room. AED pads applied per protocol. Epi-Pen administered. EMS called. Vital signs stable. Patient complained of itching and erythema in left arm around injection site. MD evaluated patient and advised to be further assessed in ER. Patient continuously evaluated by RN and EMS. Patient transported to ER in stable condition.
59 2021-01-04 tingling Patient states to feeling nauseated and had tingling in the arm and hand. Patient was sent to the ED... Read more
Patient states to feeling nauseated and had tingling in the arm and hand. Patient was sent to the ED to rule out TIA but left before being evaluated. Patient states symptoms have resolved and did not want to be seen by ED physician. Patient was educated on returning back to ED with any new concerns.
59 2021-01-05 weakness Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness... Read more
Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness, near syncopal episode, blurred vision, chest tightness, tachycardia, weakness, shortness of breath. . Returned to vaccination room, in obvious distress. Ushered by staff to chair. Unable to obtain BP via electronic machine, obtained manual , after about 10 or so minutes NIPB 106/69. Remained in room for 45 more minutes, symptoms slowly resolved. Remained with mild to moderate dizziness x 4 days. Headache, chills, chest tightness, weakness, lethargy, x 7 days..
59 2021-01-05 weakness Fever between 99.6-100 degrees fahrenheit for 24 hours. Weakness and mild nausea.
59 2021-01-05 weakness Total body and joints pain. On a scale of 1 to 10, most of the time 6 to 8. And also very weak with... Read more
Total body and joints pain. On a scale of 1 to 10, most of the time 6 to 8. And also very weak with no stamina. Lasted until 12 /25/2020. Felt horrible like I also had a fever. Although I never did run a temp.
59 2021-01-05 feeling jittery, weakness 1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 ... Read more
1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 pm dizziness, tightness around right upper arm, swelling in right axilla. afebrile. 1/6/20: 5:00 am; chilling subsided. dizziness, weakness and jittery feeling in both legs, soreness at injection site, no redness, swelling in axilla slightly improved. Heart rate 72, respirations 16, 02 sat 96%. bp 129/75. 9:00 am: dizziness, right axilla swelling gone. Soreness in right axilla, weakness in lower extremeties improving. 11:00 am : weakness and jiters subsided, right axilla remains sore.
59 2021-01-05 feeling jittery, cold extremities, tremor 6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in righ... Read more
6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in right axilla. Tightness around upper arm/axilla area. No redness at injection site. 5 am weakness in lower legs, shakey/jittery, and dizziness. Bp 129/75, HR 65, resp 16, O2 say 96. 9 am dizziness subsided 11 am weakness in legs subsided, axilla swelling subsided, soreness remains.
59 2021-01-05 numbness, tingling Numbness/tingling in fingers/hand approx 5 min after injection; pain in wrist approx 10 minutes afte... Read more
Numbness/tingling in fingers/hand approx 5 min after injection; pain in wrist approx 10 minutes after injection which has extended into hand 48 hours after injection
59 2021-01-05 muscle spasms I had tiredness, Headache , Muscle Spasms
59 2021-01-05 pain in extremity, feeling hot It is warm; Even up to the back of the shoulder to the neck is painful; Even up to the back of the s... Read more
It is warm; Even up to the back of the shoulder to the neck is painful; Even up to the back of the shoulder to the neck is painful; Her whole arm is sore up to her neck and down the arm/It is very painful/it throbs; Last night she was up all night, every 3 hours; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiration date Apr2021), via an unspecified route of administration at left arm on 30Dec2020 09:30 at single dose for COVID-19 immunization, at a hospital. The vaccine was not administered at military facility. The patient's medical history included ongoing asthma from 2005 (diagnosed 15 years ago) and allergies. For asthma She has ProAir rescue inhaler to use as needed. Breo inhaler she uses at night. She has been on it for 2 years. She has been on different inhalers. Family medical history relevant to events was reported as none. Concomitant medication included montelukast sodium (SINGULAIR) from 2005 (had been on it probably 15 years) and ongoing at 10 mg, daily for allergies; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler via resp Inhalation from 2018 (has been on it for 2 years), uses it at night, for asthma; and salbutamol sulfate (PROAIR HFA) rescue inhaler via resp Inhalation, to use as needed for asthma. The patient had no history of previous immunization with the Pfizer vaccine. For historical vaccine, the patient received Tetanus for immunization and had allergic to Tetanus, her arm swelled and she couldn't move it (which was kind of like this, but not as severe). She didn't know the brand name for the tetanus vaccine she had reaction to. She didn't have NDC, lot, or expiry. It was 40 years ago. She had the reaction when she was 18 years old. There was no vaccine administered on same date of the Pfizer suspect, and tno vaccinations within 4 weeks prior to the Pfizer suspect. It was reported that last night (30Dec2020) she was up all night, every 3 hours. She was taking Advil. Her whole arm was sore up to her neck and down the arm. She had a nurse look at it this morning (31Dec2020) and it was not red. It was warm and it throbs. No rash. It was very painful. Even up to the back of the shoulder to the neck was painful. Her arm being sore and painful was ongoing at the time of report. She had been taking Advil. The pain had stayed the same even with the Advil. The events started probably between 14:00 and 14:30, it started off sore then became more painful. At the time of reporting, she was not at home and didn't have the bottle to provide NDC, lot, and expiry for Advil. She was taking some at the office, but that was in a travel bottle and didn't have the lot, expiry, and NDC. No emergency room or physician office visit. Relevant tests was none. The outcome of the events was unknown.
59 2021-01-05 pain in extremity made my arm really sore; fever; nervous; This is a spontaneous report from a contactable consumer (p... Read more
made my arm really sore; fever; nervous; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunization. The patient's medical history was concomitant medications were not reported. The patient stated, "where I got my shot made my arm really sore for about three days. On the third day, I ran a low-grade fever-100F. The fever lasted 12 hrs. Now I'm fine. I was a little nervous about traveling but read that there was a side effect." The outcome of the event was unknown. Information on lot/batch number was requested.
59 2021-01-05 tingling This is a 59-year-old female who's possible reaction to the Covid vaccine was as follows: She had g... Read more
This is a 59-year-old female who's possible reaction to the Covid vaccine was as follows: She had gotten the vaccine at approximately 8:30 AM and had stayed at the vaccination area for about 15 minutes and felt okay. She got up to walk outside and started feeling dizzy. Her hands felt tingly. She also felt a little short of breath. She came back in and sat down and the symptoms did not seem to really improve. She states they have been about the same over the last 20 minutes or so. She was then escorted to the ED of the facility for evaluation & treatment if needed. Per the ED doctor's notes: " The patient did feel much better after just being observed here and after getting Benadryl." She was released home. Employee health followed up with her at 4:30 PM the same day & at 9:45 am 1/6/21--she reported that she was doing well at both follow ups, a little tired but had not had any repeat of previous symptoms.
59 2021-01-06 difficulty speaking Patient felt dizzy quickly progressed to hoarse voice, cough and expressed difficulty breathing
59 2021-01-06 pain in extremity Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,ho... Read more
Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,hot and swollen after the allergy shot . Itching whole body and also the roof of mouth and the back of throat was itching . Head aches . No new symptoms.
59 2021-01-06 tingling, numbness Vaccination 1/5 @ 10:30 am - mild left arm discomfort @ injection site, otherwise no symptoms On 1/... Read more
Vaccination 1/5 @ 10:30 am - mild left arm discomfort @ injection site, otherwise no symptoms On 1/6 eve, approximately 10 pm, noted worsening to severe pain in left anterior shoulder/ subclavicular area into axilla with prominent & well delineated area of swelling & tenderness, most prominent in & just below axilla, associated with numbness & tingling down the ulnar side of arm to 2 fingers (ring & little finger).
59 2021-01-06 tension headache Patient reported headache-like symptoms with pressure, tightness and extreme fatigue. Patient also r... Read more
Patient reported headache-like symptoms with pressure, tightness and extreme fatigue. Patient also reported worsening tinnitus which started 12/22/2020, prior to the vaccine administration date.
59 2021-01-07 weakness Upon awakening, exhausted feeling, severe weakness, total body aches, chills, temp 97.4 orally, slig... Read more
Upon awakening, exhausted feeling, severe weakness, total body aches, chills, temp 97.4 orally, slight nausea. Notified supervisor at work, took Tylenol 1000 mg and slept for 2.5 hours. Woke up with symptoms much reduced and went to work
59 2021-01-07 flushing tingling tounge and flushed, monitored until resolution,
59 2021-01-07 numbness Numbness on the left side of face and ear. Lasted only about 4 hours from about 5pm to about 9pm.
59 2021-01-07 migraine Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse... Read more
Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 30Dec2020 10:30 at Left arm at single dose for covid-19 immunization. Vaccine was administered at hospital and not administered at military site. Medical history included ongoing spondylolisthesis diagnosed 15-20 years ago and overweight. Her vertebrae were not in physical alignment. The patient was given steroids, but it didn't help. Steroids didn't do anything. There was no name or NDC/Lot/Exp of steroids. The patient no longer has steroids. Her back will hurt when she gains weight. Height was now under 5 feet 5 inches (164 cm). The patient had no family medical history. There were no concomitant medications. No additional vaccines administered on same date of pfizer suspect and no prior vaccinations within 4 weeks. No adverse events follow prior vaccinations. The patient experienced multiple side effects 10 hours after the vaccine and lasted 20 hours. Side effects started 20:00 - 21:00 on 30Dec2020. Side effects were classified as: Nausea, migraine headache, chills, and joint pain. The events was waxing and waning. On 31Dec2020, side effects were 75% gone by 16:00. Joint pain was completely going by 22:00-23:00 on 31Dec2020. Chills were gone between 08:00-09:00 on 31Dec2020. Nausea and migraine headache stayed until 16:00-17:00 on 31Dec2020 and then it went away. At the time of vaccination, there was a low-pressure center coming through. There was also an ice and snowstorm. She was wondering if the headaches and joint pain were due to the weather. The patient took no medication or treatment for spondylolisthesis and wondered if that had something to do with it. The patient really want to have second shot in two weeks. Investigation assessment was no. The outcome of the events was recovered on 31Dec2020. Causality assessment by primary reporter via global introspection was unknown.
59 2021-01-07 pain in extremity, weakness Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left ar... Read more
Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left arm a little itchy. Took Benadryl , slept and then felt better. Did fine with first shot.
59 2021-01-07 pain in extremity, pain in extremity 3 weeks ago tomorrow, The day after my shot I was really tired. I went to bed and when I got up and ... Read more
3 weeks ago tomorrow, The day after my shot I was really tired. I went to bed and when I got up and had a fever, horrible joint and leg pain, horrible leg pain, terrible bouts of nausea until I couldn't puke anymore. I went into the ER and got fluids and they ran tests and everything was normal. ER said it could be a moderate reaction to the vaccine.
59 2021-01-07 pain in extremity CDC called and requested I complete this report, but I do see these reactions within the normal rang... Read more
CDC called and requested I complete this report, but I do see these reactions within the normal range reported to us prior to getting vaccine. 6 hrs after 2nd shot fever of 99, headache, and arm pain. 20 hrs after shot significantly worse headache, arm pain and fatigue to point of not getting up, not walking around, and not interested in eating until later in the day. 30 hrs after shot I was up and eating normally, but continued headache 46 hrs after shot but ibuprofen adequate to cover pain today.
59 2021-01-07 pain in extremity Malaise and extreme tiredness; Malaise and extreme tiredness; Arm soreness; This is a spontaneous re... Read more
Malaise and extreme tiredness; Malaise and extreme tiredness; Arm soreness; This is a spontaneous report from a contactable Nurse. This Nurse reported events for 6 patients. This is a 1st of 6 reports. A 59-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 29Dec2020 at single dose, once by injection in the right arm, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm soreness on 30Dec2020 that lasted a few hours, malaise and extreme tiredness on 05Jan2021. Therapeutic measures were taken as a result of arm soreness included Tylenol. The patient worked in a healthcare facility and had not had COVID. The outcome of event arm soreness was recovered on 30Dec2020, and of malaise and extreme tiredness was not recovered. Reporter seriousness for arm soreness, malaise and extreme tiredness was non-serious. The reporter considered the events arm soreness, malaise and extreme tiredness were related to COVID Vaccine. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006243 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006329 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006376 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006151 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021005968 same reporter/ drug , different patient /AE.
59 2021-01-07 pain in extremity Low grade temperature that last 6 hours; Nausea; Vomiting; Diarrhea; Arm soreness; This is a spontan... Read more
Low grade temperature that last 6 hours; Nausea; Vomiting; Diarrhea; Arm soreness; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events 6 patients. This is 2nd of 6 reports. A 59-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm on 29Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. This patient had a low grade temperature that last 6 hours, nausea, vomiting and diarrhea on 05Jan2021. She also experienced the arm soreness on 29Dec2020. patient says that they had employees get the COVID Vaccine on 29Dec2020. Most said that they maybe got a little arm soreness that lasted a few hours. They took tylenol and were fine. reporter confirmed that this patient is herself. She did not have a specific physician that she sees. She sees whoever is there that day. She received the vaccine on 29Dec2020. These symptoms hit her early this morning. They hit her, then she called out of work. She talked to her provider and they were going to revisit if they wanted to do another COVID test. she has already had two negative tests. Treatment was none. Patient states she just got off the phone completing a report of side effects from several of her employees that happened within 24 hours of receiving the Covid vaccine on 29Dec2020. reporter states several employees reported headaches, tiredness, and malaise. reporter would like to know if the onset and duration for these symptoms are expected. Her question it, since they all got the vaccine on 29Dec2020, would they be experiencing these side effects 7 days post injection, this far out. No Investigation Assessment. Patient was recovered from low grade temperature that last 6 hours, vomiting and diarrhea on 05Jan2021, recovered from arm soreness on 29Dec2020, recovering from nausea. Reporter seriousness of low grade temperature that last 6 hours, Nausea, Vomiting, Diarrhea and Arm soreness was not serious. The reporter considered the events Low grade temperature that last 6 hours, Nausea, Vomiting, Diarrhea and Arm soreness was related. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
59 2021-01-07 tingling, pain in extremity, numbness From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbnes... Read more
From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbness and tingling. I went back to work I also had some weakness and being tired but that went away and weakness in my legs but that went away didn?t last long. The numbness and tingling in my face and neck did not go away. My arm is still sore. I did go to the er last night cause my blood pressure was high at home and face still numb and tingling. Just thought I better check things out. Dr wasn?t sure if it was a reaction from the covid shot he was checking for stroke issues all tests he ran were good.
59 2021-01-07 tingling Following 15 minutes of monitoring after receiving the COVID19 vaccine, the patient experience dizzi... Read more
Following 15 minutes of monitoring after receiving the COVID19 vaccine, the patient experience dizziness upon standing and reported tingling in lower limbs. Patient was monitored for an additional 20 minutes and symptoms resolved. Patient had no other complaints.
59 2021-01-07 tingling tingling LUE, LLE, Left face and left side of tongue/cheek Narrative: condition C called
59 2021-01-07 tremor, feeling cold Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she ... Read more
Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she started with kind of chills and shakes; she was not feeling too good; real high heart rate that were in the 110's that last for lasted for hours; Fever; This is a spontaneous report from a contactable nurse reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231 and expiration date unknown), via intramuscular on left deltoid on 03Jan2021 09:13 at single dose for COVID-19 prophylaxis. The patient medical history and concomitant medications reported as none. The reporter is a registered nurse that reported that she had the first Covid-19 vaccine yesterday morning on 03Jan2021 and she had side effects. She reported that she had a fever, headache, and a real high heart rate that was in the 110's that last for lasted for hours. She said that she started with kind of chills and shakes 11 hours and 40 minutes after receiving the vaccine. One minute she was fine and the next minute she was feeling chilled. By the time she got home from her mother's house, which is a hours drive, she was not feeling too good. Her fever broke today 04Jan2021 at around 04:00 and when she checked her temperature it was 98.7 degrees. She said that 100.2 degrees was the highest temperature she recorded. The patient said that it was a mild fever. Her headache started about 22:00 03Jan2021. The patient said that she still has the headache a little bit and she has been treating it with Tylenol and it has gotten better. She said that she wears a fit bit that tracks her heart rate and she can hear her heartbeat in her ears and she could hear it going fast. Caller said that her heart rate was down to 98 beats per minute at 06:30 this morning. She said that her current heart rate was Body temperature. Caller said that her high heart rate had her very concerned. She said that it is not normal. She is supposed to go back on 30Jan2021 to get her 2nd injection. Should she still plan on getting the second part of the vaccine? The reporter assessed event real high heart rate that were in the 110's that last for lasted for hours as serious with medically significant. Other events were assessed as non serious. The outcome of the events fever and real high heart rate that were in the 110's that last for lasted for hours was recovered on 04Jan2020, outcome of the event headache was recovering, outcome of the other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event high heart rate with BNT162b2 can not be completely excluded.
59 2021-01-08 discomfort First vaccine injection 12/19/2020. Symptom of fatigue. Second vaccine injection 01/07/2021: Abou... Read more
First vaccine injection 12/19/2020. Symptom of fatigue. Second vaccine injection 01/07/2021: About 3 hours after receiving the 2nd injection, I had terrible headache requiring dosages of OTC Tylenol, terrible abdominal pain/pressure similar to menstral cramping, extreme fatigue requiring prolonged sleep, nightmares (which I never have). All symptoms lasted for approximately 38 hrs.
59 2021-01-08 cold extremities Developed fever/chills next day and following day which resolved but also began having having purple... Read more
Developed fever/chills next day and following day which resolved but also began having having purple/blue fingertips - both pads and nails - when my hands are cold. This began on day after vaccine and continues to date.
59 2021-01-08 tremor Pt reported onset of "quivering" lips & Headache 15 min after vaccine. Vitals recorded. MD contacted... Read more
Pt reported onset of "quivering" lips & Headache 15 min after vaccine. Vitals recorded. MD contacted & interviewed (Dr.) patient. Ambulance called. Vitals re checked Benadryl 25 mg PO given. Paramedic & Ambulance arrive 4:35 59 y/o who states she had anaphylaxis before her symptoms started the same as today. C/o quivering lips & H/A No rash or respiratory comp (EMT's exam - normal except ? movement. Assessment - Possible allergic RXN Plan - Ambulance transport to ED
59 2021-01-09 feeling hot, tingling I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 210... Read more
I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 2100 on 1/8, began to develop a lot of pain at the injection site. Within 2 hrs of that time, I developed other symptoms, which include total body (bone and joint) pain (especially in my knees), and what I would describe as a "bad sunburn type" rash across my cheek bones, bridge of my nose, and orbital area. Small raised bumps to this area, with swelling, and a feeling of pins and needles stabbing me all across my face. My airway was fine, and at no time did I feel shortness of breath. I was unable to sleep due to the bone and joint pain, and felt the need to walk continually (it was more painful to stay in one position). These symptoms persisted throughout the day (Saturday 1/9/21), noting at 5pm I described myself "miserable" to my friends and family. All symptoms described above, were at their most elevated intensity between the hours of 1700 - 0400. At 0400 Sunday (1/10/21) I felt a gradual release of the body aches, enough so that I could sleep until 0800. At this time, 1300 (Sunday 1/10) I note that I still feel "flu type" body aches, but constant pain has diminished in intensity by estimated 50%. The sunburn type redness and swelling across my face/orbital area has also less by 50% (there is still redness, mild swelling, warmth, and some raised bumps across this area; pins and needles feeling is gone).
59 2021-01-10 numbness Patient experienced right eyelid and cheekbone numbness following the first dose. She received her s... Read more
Patient experienced right eyelid and cheekbone numbness following the first dose. She received her second dose 11 days after the first in error. Following the second dose, she reported cheek numbness and nausea, which had resolved when I spoke with her on 1/11/21.
59 2021-01-10 numbness Patient received the first dose of the COVID vaccine on 12/28/20, and the second dose on 1/8/21 (11 ... Read more
Patient received the first dose of the COVID vaccine on 12/28/20, and the second dose on 1/8/21 (11 days later instead of 21 days). The patient reported experiencing right eyelid and cheekbone numbness and a minor headache after the first dose. She had numbness to her right cheek again on 1/8/21 and some nausea that has resolved. I spoke with the patient on 1/11/21 and she is feeling well.
59 2021-01-10 pain in extremity, tingling sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips o... Read more
sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips of fingers (feeling pricked in the fingertips).
59 2021-01-10 pain in extremity Hand Pain
59 2021-01-10 pain in extremity That evening developed itching and had a rash over upper body and arms, still on arms in AM, went aw... Read more
That evening developed itching and had a rash over upper body and arms, still on arms in AM, went away on it's own, since then have episodes of chills and a trigger finger developed while sleeping on right #4 digit of Right hand, tightness in chest and last night developed pain in left arm and fingers that was very painful and did not respond to 800mg of Ibubrofen. Not sure if related.
59 2021-01-10 pain in extremity Arm sore over night Sunday to Monday and began to itch. Area still itches and is red and swollen ar... Read more
Arm sore over night Sunday to Monday and began to itch. Area still itches and is red and swollen area where shot was given
59 2021-01-10 pain in extremity soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 o... Read more
soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 of 101.3; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; had joint pains/knees and hip joint pain; severe fatigue; muscle pain; This is spontaneous report from a contactable nurse (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in right arm on 30Dec2020 14:15 at first single dose (0.3 cc, but really uncertain of dose) for covid-19 immunization. Medical history included COVID virus from Nov2020 to 2020 (The patient was not hospitalized. It was a mild case and lasted about 10 days. she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue). The patient's concomitant medications were not reported. The patient did not receive any other vaccines at the same time or 4 weeks prior. No problems with vaccinations in past or events. Caller reported she had the first injection of the Pfizer BioNTech COVID-19 vaccine on the 30Dec2020 and having some side effect symptoms and her supervisor recommended for her to report these things, they are not life threatening, obviously, but things were still lingering. Side effect of severe fatigue started on the 31Dec2020 and lasted for 72 hours. It was so severe, now it is mild. The patient reported soreness around the injection site. Had a fever on the night of the 31Dec2020 of 101.3 and had that for 6 hours then it dissipated and was gone. Had never had a fever after injections before. Had severe arm pain that usually goes along with an injection. It started also that night of 31Dec2020. She had rolled over in the middle of the night and it hurt. That lasted for about 48 hours, but it has improved. Had some muscle aches since 31Dec2020 but that had improved and had joint pains since 31Dec2020. What was worrisome was the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes, since 31Dec2020. The patient was still having that and that is why she was so concerned because shouldn't that have gone away after a week. Had knee and hip joint pain, but that had improved. Again, mentioned she had never had that before with an injection. The patient received vaccine at her workplace. Some of her coworkers got it the same day and no one else has this. Mentioned she did have COVID virus back in Nov2020 and wonders if this correlates with her getting the vaccine. Was not hospitalized or notified she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue. This is the same way she felt back when she had the virus back in November. The patient was concerned about having these side effects would it be okay for her to get the next injection in 3 weeks. AEs did not require a visit to emergency room and physician office. No further details provided. Outcome of the events Fever was recovered, of event swollen and painful lymph nodes was not recovered, of events knees and hip joint pain, fatigue, muscle pain, severe arm pain was recovering, of event soreness around the injection site was unknown. The reporter considered the events severe fatigue, fever, swollen lymph nodes and pain under right arm, knees and hip joint pain as serious (medically significant). The reporter considered the events severe fatigue, fever, severe arm pain, muscle ache, swollen lymph nodes and pain under right arm, knees and hip joint pain as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-01-10 pain in extremity 06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than t... Read more
06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than the 6th, 99.9-T Sat the 9th vomiting 2 times---she took Tylenol 325mg times 2 for her fever-T-99.7 Sunday the 10th vomited 10 times-99.9 T This Am the 11th of January@0100-cramping--------99.1 T
59 2021-01-10 tremor She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsen... Read more
She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened; From the time she got the vaccine to now, she has lost 20 lbs; shake/shaking; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; She has been sick since Wednesday; itching all over from head to toe; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension and allergic to ace inhibitors. There were no concomitant medications. Patient was calling about the Covid Vaccine. She was having an allergic reaction. She did not know what to do to stop it. She went to the ER yesterday (04Jan2021). She had been sick since Wednesday (30Dec2020), she was itching all over from head to toe since 30Dec2020, she got a prescription for Prednisone, she took 2 doses yesterday, 1 dose today, and would take another this evening. She took Benadryl, an hour ago and had an episode, and so she had to jump in the shower and let the cold water run to stop itching, the itching did not stop but it has minimized. She put Benadryl gel and she was still itching, she had taken enough Benadryl. Patient asked what is the best way and if she needed an IV of something, she went to ER on Sunday, she was not seen by doctor, it was a nurse practitioner, she didn't do anything but just listen to her and she only looked at ankles to check for swelling. Patient stated that she had been drinking water and urinating, she had no appetite and lost 20 lbs. Patient confirmed that she got her first dose of the Covid vaccine on 30Dec2020 at 1 o clock, the itching started the same day at 5 o clock, the itching was from head to toe. She experienced swelling in the lips, throat, and eye lids, which started 02Jan2021. She began losing her appetite on 30Dec2020. From the time she got the vaccine to now (05Jan2021), she has lost 20 lbs. An hour ago (05Jan2020) she had an episode, which made her shake, and she did not have the shakes before, this was the first date she started shaking. Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened. Her 2nd dose was scheduled in 21 Days. However, she may not get the second dose, patient stated that she could not get through this no more. She had no positive test for Covid prior to vaccine. She had no antibody test prior to the vaccine. She had not any issues with vaccines in the past. Patient stated that if she was still feeling this way, she would go to a different hospital. When she went to the ER, she was not hospitalized, they sent her back home the same day. Patient would like to know if there was anything that can remove the vaccine from the body. The outcome of the events itching all over from head to toe, loss of appetite, swelling in the lips, throat, and eye lids was not recovered, of the other events was unknown. Information about lot/batch number has been requested.
59 2021-01-11 weakness 12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21... Read more
12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21; woke up 'not feeling well'; weakness, faint, shaky. You contacted your brother and proceeded to the ER. 2am started to feel better 3:30 am dishcarged home. Wope up at 6:30 am. Chills, achy. Went to work; felt chilled all Monday into the evening until eventually subsided. **2 negative COVID in Nov **Flonase for allergies **2nd Pfizer vaccination on 1/9/2020. Milder symptoms for couple of days, into Tuesday. 1/12/2021; mild chills, mild body aches.
59 2021-01-11 feeling cold, tingling Patient describes feeling of "cool waves" over her whole body. States it lasts on a few seconds and ... Read more
Patient describes feeling of "cool waves" over her whole body. States it lasts on a few seconds and then goes away. Some tingling in upper extremities noted initially , but none now. Patient declined to remain longer for observation. She had her husband here for transportation home. Advised patient to call Health Services if other symptoms occurs She will do this. Advised ER if symptoms emergent.
59 2021-01-11 numbness, tingling, cold extremities After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I dev... Read more
After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I developed a goose egg size swelling under my left armpit, numbness, tingling in my hands, and feet that proceeded with coldness and parlor of my hands, this has occurred daily along with headaches, reddish blotchy patches on my skin. My symptoms progressed on 7 Jan to needle prick sensations all over my body, to include the numbness and tingling, cold hands and feet. On 8 Jan I went to see my doctor and explained my symptoms, labs were drawn. 12 Jan i was placed on Medrol Dose pack, symptoms stills present.
59 2021-01-11 pain in extremity Arm aching Fatigue Minor hives for three days Treated with Zyrtec and Benedryl
59 2021-01-11 tingling, numbness numbness in right fingers along with tingling. moved to back of neck and side of face. right side ... Read more
numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL01284, expiry date not reported), via an unspecified route of administration in the right arm on 31Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included pituitary tumor/prolactinoma. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Concomitant medications were none. On 31Dec2020 at 10:45, the patient experienced numbness in right fingers along with tingling. The patient moved to back of neck and side of face. The right side of face was completely numb. It began with tingling and then moved to numbness. Her right eye was blurred for short period. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
59 2021-01-12 burning sensation, tingling Patient called at 12pm to inform us that about 3 hours after her 1st Covid vaccine she was moving he... Read more
Patient called at 12pm to inform us that about 3 hours after her 1st Covid vaccine she was moving her arms around to prevent soreness and then both arms began to feel itchy, tingling, & burning & this moved up into her neck. She was encouraged to come in and be seen, but she does not feel that is necessary at this time. She reported her symptoms have since improved and that she had a similar reaction when she received the shingles vaccine. I encouraged patient to monitor her symptoms and to come be seem if she gets worse. She reported that she is feeling much better at the end of our phone call.
59 2021-01-12 depressed level of consciousness Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arou... Read more
Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arouse me. When he tried to get me up out of bed I collapsed and then had syncopal episode. He call 911. Paramedics could not get blood pressure and I was diaphoretic and body temp was cold. They rushed me to the hospital. My blood pressure was dangerously low along with my body temperature. I was given epinephrine and LEVOPHED to get a blood pressure. I was warmed up. Then I had GI issues of vomiting, diarrhea, nausea. I spend 4 days in hospital.
59 2021-01-12 flushing, pain in extremity Generalized itching, hives, after receiving second dose of COVID 19 vaccine today, 1/11/2021 at 11:3... Read more
Generalized itching, hives, after receiving second dose of COVID 19 vaccine today, 1/11/2021 at 11:30 in right deltoid. Pt tolerated dose #1 in left deltoid. She developed mild arm " weakness" and soreness that lasted several days. She completed a VAERS report after her first dose. She began to feel " itchy all over" at 15:00. She noticed hives under her bilateral breasts. She felt " flushed" and her scalp and face felt itchy as well. No SOB or CP. NO wheezing. She has a hx of allergies to KEFLEX/PCN.
59 2021-01-12 pain in extremity, flushing Dose #2 received on 1/11 at 11:30. Pt began to feel itchy all over at 1500. She noticed a rash under... Read more
Dose #2 received on 1/11 at 11:30. Pt began to feel itchy all over at 1500. She noticed a rash under both of her breasts as well as her face, scalp. She felt " flushed". No tongue or lip swelling, No wheezing. she had arm soreness and muscle " weakness" in the left arm after dose #1 and completed a VAERS form at that time but had completely recovered prior to receiving injection #2
59 2021-01-12 cold extremities 1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter... Read more
1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter 5:30pm Shivering muscle pain temp 101 took motrin 1/9/2021 Felt 80% ok 1/10/2021 and 1/11/2021 95% better Appetite decreased from 1/8/20201-1/11/20201 ( dry mouth, fever, chills, lightheadedness, muscle pain)
59 2021-01-12 tremor Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a ... Read more
Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a check up with my doctor with no symptoms.. Injection on left high upper arm redness around . Muscles pain and tremors of my hands , tired Diarrhea for two days and sweats.
59 2021-01-13 weakness Fever, chills, headache, major joint pain (hips, shoulders, knees, elbows, ankles), generalized weak... Read more
Fever, chills, headache, major joint pain (hips, shoulders, knees, elbows, ankles), generalized weakness
59 2021-01-13 feeling hot Patient began to experience neck pain on the same side she received her injection along with tightne... Read more
Patient began to experience neck pain on the same side she received her injection along with tightness and stiffness. Patient also experienced pressure, popping and burning in and around bilateral ears. Patient expressed she felt hot, and had a headache. Patient verbalized she had a lot of allergies to environmental substances.
59 2021-01-13 muscle spasms wanted to sleep; eyes being weak and hurting; eyes being weak and hurting; sore throat; tiredness; h... Read more
wanted to sleep; eyes being weak and hurting; eyes being weak and hurting; sore throat; tiredness; headache, muscle spasms in abdomen; headache, muscle spasms in my abdomen; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 02Jan2021 at a single dose in left arm for COVID-19 protection. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 18 or 19 years ago), COVID-19 previously and did not have side effects like this (the patient had COVID 19 last month and did not feel this bad at all. Patient was asymptomatic). Concomitant medication included ongoing liraglutide (VICTOZA), ongoing insulin detemir (LEVEMIR), both started about 2 or 3 years ago for diabetes Type 2. She received the product vial workplace policy, so it was not specifically prescribed to her. The patient received the first dose of the vaccine on 02Jan2021, and starting on 06Jan2021, she started with headaches, and muscle spasms all over her abdomen and back. Headaches was reported as worsened. The headache will not go away and even with Tylenol it still lingers. Muscle spasms all over her abdomen and back was reported as worsened. Her eyes were weak and hurting, started on 08Jan2021. She was so tired, she wanted to sleep. The tiredness, started on 06Jan2021, and it is like in the morning she is okay, but then during the day she just got worse and worse and worse. Her sore throat starting 07Jan2021 night, and this morning it was really bad. Throat was very sore was reported as worsened. She received no other vaccines on the same day at the COVID vaccine. The patient was wondering if those are side effects of the vaccine, because the patient had COVID-19 previously and did not have side effects like this. This is a non-serious report. The outcome of event eyes being weak and hurting, and wanted to sleep was unknown, outcome of the other events was not resolved.
59 2021-01-13 tremor 1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking o... Read more
1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking of hands, chills and present at this time 1/14/21
59 2021-01-14 weakness chills slight fever headache fatigue body aches no energy exhaustion
59 2021-01-14 feeling hot I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had ... Read more
I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had taken one 325mg Tylenol and one 200mg Ibuprofen approximately 60 minutes prior to receiving vaccine (which is what I did prior to the first vaccine). I was doing great initially following the vaccine. I took another 325mg Tylenol and 200mg Ibuprofen when I went to bed at 2000 1-12-21. At 0300 1-13-21 I woke up feeling nauseated and when attempting to turn over to my right side I moaned loudly because I could not hardly move my left arm. My husband was woken and turned on the bedroom light and we noted a 3 inch bruise and large knot on my left deltoid at the injection site. He told me that I felt warm. I took my temperature that was 101.2 degrees. I took 650mg Tylenol and that time. At 0500 1-13-21 I was having chills, muscle and joint aches. I could not fully close my hands into a grip. My "brain" hurt, not a headache but literally it hurt to move my head. I would occasionally get a sharp pain in the front and back of my head. My temperature went to its highest at approximately 1500 1-13-21 to 102.5 degrees. I continued to offset Tylenol with Ibuprofen throughout the day. At 2000 1-13-21 my temperature was 101.8 and began to trend downward. I went to bed and when I woke up on 1-14-21 I felt 100% better with just a little fatigue from the inability to sleep the day prior.
59 2021-01-14 flushing About 2 min after receiving injection, I felt an intense flushing feeling all over, it felt as if my... Read more
About 2 min after receiving injection, I felt an intense flushing feeling all over, it felt as if my blood had turned into lava. About a minute after that I felt a "tickle" in my throat. The same sensation I felt when I had my reaction to Gadolinium. I tried to swallow, and it was a little difficult. I did NOT feel short of breath. I tried to calm down by doing slow concentrated breathing. I continued to take small sips of water to gauge my swallowing ability. After about 2-3 minutes, the flushing sensation subsided, and swallowing started to improve. I had brought my Epinephrine pen with me. About 1-2 min after the flushing sensation had subsided,, it came back and my swallowing ability got much worse, to the point I couldn't swallow a small sip. I was breathing well, and did NOT feel short of breath, but gave myself my Epinephrine injection at that time. A Rapid Response was called at that time, my vitals signs taken, an IV inserted, 911 called. O2 sats were fine mid 90's, heart rate was mid 80's, BP was elevated, I don't remember the exact systolic 170-180, but my diastolic was 116. It took the ambulance approximately 10-15 min to arrive. By the time the ambulance arrived, I was feeling close to my baseline and my BP was improving. I was seen by the ER MD, and feeling fairly well, my throat still felt a tiny bit tight, but no difficulties swallowing. The plan was to complete treatment with IV steroids, Benadryl, and Pepcid, then be observed for a few more hours. This was approximately around 16:30. Not more than 5 min after MD left my room, I got the flushing feeling, and throat closing feeling again. While the medications were being prepared these symptoms increased, ( I could still breath adequately and vital signs were still OK. It took about 10 minutes after meds were given for symptoms to begin to subside ( No epi given) I was observed until 21:30 then discharged. I am taking 50 mg daily x 3 days, 25mg Benadryl q 8hrs x 3 days, and 20mg Pepcid bid x 3 days. I feel fine , no further episodes
59 2021-01-14 pain in extremity Severe arm pain; severe body aches and headache. Fever
59 2021-01-14 pain in extremity Diarrhea; severe chills; sore arm; This is a spontaneous report from a contactable other healthcare ... Read more
Diarrhea; severe chills; sore arm; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) then received the second dose (lot number: EK 9231, expiration date: not reported) on 08Jan2021 13:45 both via an unspecified route of administration on the left arm at a single dose for COVID-19 immunization. Medical history included that the patient had allergies to medications, food, or other products such as Penicillin, Sulfa drug and pork. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ascorbic acid (VIT C), ergocalciferol (VIT D) and biotin (BIOTIN). On 08Jan2021 22:45, 9 hours after vaccine the patient experienced diarrhea, severe chills and sore arm. As treatment, patient received ibuprofen (ADVIL) and fluids. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number (first dose) has been requested.
59 2021-01-14 tremor, involuntary muscle movements Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Resi... Read more
Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Residents blood pressure was elevated as well and she complained of nausea. Resident was fine this morning and the past several days with no complaints. This resident has a history of muscle spasms and tremors as well as some catatonic states in the past.
59 2021-01-15 pain in extremity Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later ... Read more
Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later severe pain in L shoulder with marked restriction in movements. Persisting pain in L shoulder which wakes me up at night. Unable to do my daily workouts and yoga.
59 2021-01-16 tingling left arm became red with rash that was raised like small pimples, I felt like something was prickin... Read more
left arm became red with rash that was raised like small pimples, I felt like something was pricking me from the inside out then felt a little uneasy and face was itching with a small hive on my right cheek. My arm became bright red, I took a 25 mg benadryl which subsided some of the redness. I finished my shift and drove home about 5 pm still felt like I had prickly heat I took another 25 mg benadryl slept. I was extremely tired the next day which I could not tell if it was from the vaccine or benadryl or both. I work in a doctors office .
59 2021-01-16 tingling Noted prior to having drug reaction and was planned to wait 30min post-vaccine. She felt "pins and n... Read more
Noted prior to having drug reaction and was planned to wait 30min post-vaccine. She felt "pins and needles" 20minutes after vaccine admin and then began itching. Presents to observation unit with red rash, 3-4 hives across upper and mid-back. Endorses itching on scalp as well as trunk. No rash noted on hands, arms, or face. Benadryl given after pt consulted with Dr. mild relief of symptoms. MDs spoke extensively with patient. She was ok to go home after her spouse arrived to drive her.
59 2021-01-16 tingling Vaccine administered approx. 1320, she was waiting in the observation area and about 20-25 minutes s... Read more
Vaccine administered approx. 1320, she was waiting in the observation area and about 20-25 minutes she started to feel a "pins and needles" sensation on her arms and head. Right after that, pt describes diffuse puritis on scalp, across upper and lower back. Itching continues down extremities while being observed. Red rash, 4-5 hives on upper and mid-back. She is visibly scratching her neck, head and back and appears restless because of the intense itching. Assessed by Dr (IM) and Dr(ID); 50mg po Benadryl ordered and given to pt. She endorses mild relief from symptoms.
59 2021-01-17 feeling hot, muscle spasms, tremor Dizziness, weakness is extremities. Cramping in legs. warm sensation in chest, back arm legs. Shaki... Read more
Dizziness, weakness is extremities. Cramping in legs. warm sensation in chest, back arm legs. Shakiness. Feeling of passing out. Foggy thoughts.
59 2021-01-17 feeling hot Became hot and nauseated
59 2021-01-17 pain in extremity Premedicated with Ibuprofen 400mg about 2 hours before injection yesterday. Woke up this morning w... Read more
Premedicated with Ibuprofen 400mg about 2 hours before injection yesterday. Woke up this morning with chills, low grade fever, mild nausea, a headache, and a very sore arm. By late morning I had a fever of 100.9 and a severe headache. Early afternoon fever went up to 102.1. At this time I took ibuprofen 400mg and sumaptriptan 100mg. Fever came down and heaeache lessened.
59 2021-01-17 pain in extremity On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vo... Read more
On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vomiting. At midnight I went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement. I had complete occlusion of the right coronary artery
59 2021-01-17 pain in extremity I experienced soreness in my right arm at the injection site and a few days later it went away.
59 2021-01-18 weakness Pt had nausea after 2 hours and felt tired/heavy feeling. Took Ibuprofen. On day later, experien... Read more
Pt had nausea after 2 hours and felt tired/heavy feeling. Took Ibuprofen. On day later, experienced more nausea and lack of appetite, and then had a terrible headache. It got worse and she experienced neck stiffness and her blood pressure was 175/95 at 4pm on 1/8. She rested and felt better about 24 hours later. She felt normal again after a few days.
59 2021-01-18 weakness Difficulty breathing, high blood pressure and heart rate. Very sick for the next 3 days...bedridden... Read more
Difficulty breathing, high blood pressure and heart rate. Very sick for the next 3 days...bedridden due to sickness; nausea, shaking, weakness, muscle aches, joint aches, severe headache, stomach pain, skin blisters, fever and chills, injection site pain, tiredness, dizziness. By the 4th day I am still weak and now I have skin blisters on my body in various places. Today is the 5th day and I still feel weak and slightly sick, nausea and fatigue and more skin blisters, fever.
59 2021-01-18 breast pain I received my shot in upper left arm 1/15/21 @ 1:45pm and on Sunday 1/17/2021 in am I'm noticing pai... Read more
I received my shot in upper left arm 1/15/21 @ 1:45pm and on Sunday 1/17/2021 in am I'm noticing pain on the left side of my breast and armpit area. I felt my lymph nodes and they are swollen as well. I stopped wearing a bra because it was painful.
59 2021-01-18 numbness Within 1 hour of vax, with numbness to left chin/neck and ear region. Neg PMH. Stable. Directed to ... Read more
Within 1 hour of vax, with numbness to left chin/neck and ear region. Neg PMH. Stable. Directed to f/u with occupational health services.
59 2021-01-18 pain in extremity Sore muscles , especially legs. My legs are achy.
59 2021-01-19 flushing Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy ... Read more
Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy head" feeling. Hypertensive at time BP left arm 171/95 HR 79, RR 26, 99% RA. Apple juice, and cracker provided, and emesis bag provided. Patient was already waiting for thirty minutes time (she was 15 minutes into her wait time). She reported having a progression of nausea and dizziness Repeat vital signs at 1345 139/100 HR 76, RR 24 Pox 96% RA. First responder was called and patient was assisted into wheelchair and taken to the ER for further evaluation.
59 2021-01-19 tingling, weakness, flushing Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minut... Read more
Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minutes. Two hours later, itching began on left leg and arms. Noted red blotches to these areas. Face began to feel very prickly and flushed, felt lower lip swelling and left eye began to feel funny. Observed one hive to cheek. Was able to take a Benadryl 25mg capsule within about 10-15 minutes after this developed. Symptoms began to subside after this. Felt back to normal the next day. Just moderate injection site pain for 1-2 days.
59 2021-01-20 weakness severe heartburn; Soreness at injection site; Fatigue; Fever up to 101.8; achenes and weakness; ache... Read more
severe heartburn; Soreness at injection site; Fatigue; Fever up to 101.8; achenes and weakness; achenes and weakness; first dose of BNT162B2 on 20Dec2020/second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 59-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) intramuscular at left arm on 06Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included diabetes and hypertension. no allergies to medications, food, or other products. other medications in two weeks included hydrochlorothiazide, lisinopril, atorvastatin, metformin and colecalciferol (D3) and fish oil, tocopherol (OMEGA 3 [FISH OIL;TOCOPHEROL]). the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took first dose of BNT162B2 (brand=Pfizer, Lot number: EJ1685) on 20Dec2020 04:00 PM via intramuscular at left arm at single dose for COVID-19 immunization (59 years old) and had muscle soreness at greater injection site. Patient experienced soreness at injection site, Fatigue, Fever up to 101.8, severe heartburn, achenes and weakness, all on 07Jan202101:00 AM. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect.
59 2021-01-20 weakness Extreme fatigue, I even had to take days off where I sat in the dark in my living room unable to do ... Read more
Extreme fatigue, I even had to take days off where I sat in the dark in my living room unable to do anything due to lack of energy. The week of the vaccine I had to go 3 days early due to the exhaustion. I also had stomach pain and bowel issues. I went to the clinic and the first time they thought it was diverticulitis and the second time they ordered a CT scan of the abdomen and some labs and they all came normal.
59 2021-01-20 difficulty speaking 1430 - Employee vaccinated, observed for 15 minutes, no symptoms... returned to work. 1600- develop... Read more
1430 - Employee vaccinated, observed for 15 minutes, no symptoms... returned to work. 1600- developed headache while working, took Excedrin 325 mg, (x2), by mouth. 1630- tightness of throat, raspiness, dizziness.... returned to where vaccine was given. METS team called and taken to ER.
59 2021-01-20 difficulty speaking Covid Vaccine (Pfizer)administered at 1430..... observed for 15 minutes... went back to work. 1600 ... Read more
Covid Vaccine (Pfizer)administered at 1430..... observed for 15 minutes... went back to work. 1600 - started with headache, took two tablets of Excedrin 325 mg by mouth. 1630-- tightness of throat, raspiness, dizziness..... return to where vaccine was given initially., heart rate 104 Emergency team called and taken to ER.
59 2021-01-20 facial paralysis, tingling Pfizer-bioNtech COVID-19Vaccine EUA Approximately 2-3 hours after the vaccine was administered, I no... Read more
Pfizer-bioNtech COVID-19Vaccine EUA Approximately 2-3 hours after the vaccine was administered, I noted tingling and a "tight" feeling on the right side of my face. I have had bells palsy before and if felt the exact same way. I noted drooping of the right side of my mouth, stabbing pain in my right ear. This lasted for 24 hours, currently, slight numbness remains at corner of right side of mouth and occasional stabbing pain right ear.
59 2021-01-20 feeling jittery 2 Hours post vaccine pt started feeling dizzy, lightheaded and "weird inside"/jittery
59 2021-01-20 migraine I received the Covid vaccine on December 21. On December 30, I woke up and was unable to maintain my... Read more
I received the Covid vaccine on December 21. On December 30, I woke up and was unable to maintain my balance. I developed very severe migraine headaches and was hospitalized. I still have not regained my balance. I have had a couple of courses of prednisone and migraine medication. My neurologist is setting up IV I G transfusions feeling that I?m having an auto immune response to the vaccine.
59 2021-01-20 pain in extremity chills , muscle ache , arm hurting more than 1st shot
59 2021-01-20 pain in extremity Pain at injection site Arm, shoulder, neck pain Headache Fatigue Chills Nausea
59 2021-01-20 pain in extremity she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hur... Read more
she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hurt (injection site); This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration in the arm on 02Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received her first Pfizer covid vaccine dose on 02Jan2021. She gets tested regularly at work. On 04Jan2021, she tested positive for the Covid virus. She had a headache, not feeling great on Friday, after she was diagnosed with the Covid virus, but no symptoms before. No side effects from vaccine, other than her arm barely hurt (injection site) in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
59 2021-01-20 tingling, tremor Body shaking; Chills; Tingling; Nauseous; Body ache; Tiredness; having like little sweat; This is a ... Read more
Body shaking; Chills; Tingling; Nauseous; Body ache; Tiredness; having like little sweat; This is a spontaneous report from a contactable nurse (reporting for herself). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration from 08Jan2021 07:40 at single dose for COVID-19 immunization. Medical history included hypertension, high cholesterol and COVID-19 survivor from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had historical vaccine of first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient stated, "I am calling to report a side effect from the vaccine (Clarified COVID-19 vaccine). I am a health care worker, I got the first dose I was fine but I got the second dose last Friday and I woke up hour later with terrible chills, tingling, my body shaking. It was not half an hour later, it was hours later. I took it at 07:40 in the morning at work and then I came home, I was fine but then chills woke me up in mid night Friday it was Saturday, let's say Saturday morning 12 am. I woke up with chills like, I am in refrigerator and I felt like I wanted to warm it but I did not, I felt nauseous, it happened like two different times and after that I took like Motrin (treatment) I did not have any temperature but I have like body ache and after that I started having like little sweat and tiredness. I just call my job now. Having the same symptoms now." The patient took Motrin and Tylenol and underwent lab work at the hospital with unknown result. The patient think that the events were related to COVID as the patient stated, "I think so because I woke up with the chills extreme chills. I never felt that way, it's like the last time when I felt it, when I had COVID, I woke up with extreme chills the only difference between this one was that I didn't have a temperature with these chills but with COVID I have temperature but this one was extreme chills." The outcome of the events was unknown.
59 2021-01-21 hot flush, numbness, tingling, speech disorder Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and ting... Read more
Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and tingling of left arm, cheek, and tongue lasting 1.5-2 minutes. Numbness starts in elbow and radiates up and down arm. These episodes happen at various times thorughout the day. Sometimes her arm feels heavy. Has had an episode involving lip numbness that affected her seaking. Sometimes gets hot flashes lasting a few seconds. She contacted PCP to re-establish care on 1/11/21 after about 2 weeks of consistent, infrequent episodes. Never experienced this before. On 1/14 pt had an in person visit where she was evaluated by PCP. At ambulatory visit, BP 174/96. Other vital signs normal. Upper extremity exam: wrist (left, Phalen's test positive, Tinel test positive, no deformity, no crepitus), wrist (right, normal range of motion, Phalen's test negative, Tinel test negative), hand grips 5/5 bicep 5/5 tricep 5/5. Differential diagnosis: TIA, carpal tunnel syndrome, transient neurological event, shingles, hypertensive urgency. Anxiety could be component as well. Pt started ASA 81 mg QD and amodipine 5 mg QD. Plan to get carotid Dopplers to rule out TIA/stroke. Consider MRI in the future. 1/16/21: Pt developed left arm/leg numbness and tingling 0530 and reported to ED with stroke-like symptoms. During this encounter, pt states that she experiences these 1-3 minute episodes of tingling/numbness every hour or so (initially only had 1-2 per day, became more frequent in days immediately preceding 1/16). Pt reports not being able to stand that morning due to weakness in lower extremeties, though the symptoms resolved after sitting down. The patient denies any weakness to the right side, along with any family hx of stroke or headache. She takes omeprazole, amlodipine, and a baby aspirin daily. She does not currently follow up with a neurologist. The patient had lab work done yesterday and also recently had a US of her carotid artery which was unremarkable. She denies any weakness, numbness, or tingling currently. There are no other concerns at this time. The onset was 3 weeks ago. The course/duration of symptoms is worsening and episodic: lasting 3 minutes and with a frequency of every hour. Location: Left face, left upper extremity, left lower extremity. The character of symptoms is weakness, tingling and numbness. SBP 182/86. Temp 97.6 F. CT head ngative, bloodwork unremarkable, chest X-ray negative. Pt admitted for MRI of brain and C-spine. 1/17/21: Hospital notes note that symptoms apear to worsen when pt is stressed or she talks about it. MRI of brain w/ and w/o contrast completed and unremarkable. Pt declined C-spine MRI with and without contrast. Pt discharged. 1/19/21: Pt presented to outpt ambulatory appointment to follow up with worsening episodes of tingling in left arm/leg, numbness and tingling in mouth - is now effecting balance. Considering testing for other diseases such as syphilis, Lyme disease, multiple sclerosis, Guillaine-Barre. Priority status on referral to neurologist.
59 2021-01-21 numbness, weakness Patient began complaining of weakness and chest pressure after receiving COVID-19 vaccine. A code bl... Read more
Patient began complaining of weakness and chest pressure after receiving COVID-19 vaccine. A code blue was called, and the patient was taken to the emergency department for further workup. In the ED, the patient was evaluated for hypertension and chest pressure and subsequently discharged after a negative workup (normal EKG, normal troponin). On 1/17, the patient returned to the ED with complaints of numbness in the left arm from fingertips to elbow, with sensation slowly returning over the next 10 minutes. A head CT scan was performed, showing bilateral acute on chronic subdural hemorrhage (possibly related to fall patient reported having on 12/5/20 down 10 steps of stairs). The patient was eventually discharged on 1/19.
59 2021-01-21 tenderness, pain in extremity Fever, chills , body aches, for 24 hours. Fever finally broke after soaking 2 sets of pjs. Back ach... Read more
Fever, chills , body aches, for 24 hours. Fever finally broke after soaking 2 sets of pjs. Back ache. Sore arm. I've recovered from all of that with tylenol. but I have swelling and tenderness under the arm, lymph nodes?
59 2021-01-23 weakness 10 pm started with uncontrollable chills and headache about 5 am fever body ache nauseated Next day... Read more
10 pm started with uncontrollable chills and headache about 5 am fever body ache nauseated Next day sat 1/9 2pm diarhea lasted 24 hours Monday fatigue headache and body ache continued Tues headache fatigued and short of breathe wed woke up with sl headache and weak by dinner time felt better
59 2021-01-23 pain in extremity 1630 developed sore shoulders, left arm. 1800 developed minor HA No treatment, went to bed 1/20 0500... Read more
1630 developed sore shoulders, left arm. 1800 developed minor HA No treatment, went to bed 1/20 0500 awoke to severe HA, muscle aches. Took Tylenol. Symptoms resolved over 48 hours
59 2021-01-24 difficulty speaking Approximately 10 minutes post injection, subject began to feel throat tighten. After taking a drink ... Read more
Approximately 10 minutes post injection, subject began to feel throat tighten. After taking a drink of water, the subject felt the throat tightness becoming worse. The patient could talk but her voice wounded horse. Heart rate increased. After consulting with physician at vaccine administration site, patient was transferred to the emergency room for treatment. Blood pressure was 200/100 in the emergency room. Patient was treated with benadryl, steroids and pepcid. Patient recovered
59 2021-01-24 feeling cold, pain in extremity sore arm for five days extremely cold body aches dry cough extreme fatigue
59 2021-01-24 numbness, pain in extremity, tingling, muscle spasms Started with arm pain one day after vaccination. Pain gradually got worse bilateral leg cramps four... Read more
Started with arm pain one day after vaccination. Pain gradually got worse bilateral leg cramps four days later escalating into tingling, numbness and pressure. Office visit with primary on 1/11/2021. Pain escalated into not being able to walk Patient went to ER on 1/20/21. Patients condition is ongoing.
59 2021-01-24 numbness Left side of my face became numb. Then my eye, tongue and throat began to swell. I stopped and purch... Read more
Left side of my face became numb. Then my eye, tongue and throat began to swell. I stopped and purchased Benadryl. The swelling started to diminish after about 4 hours, but tingling and slight numbness continued for about 3 days.
59 2021-01-24 muscle spasms muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 59-year-old fem... Read more
muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 19Dec2020 for the first dose (lot number and expiry date unknown), and on 09Jan2021 for the second dose (lot number: E11685, expiry date: May2021) both at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first shot on 19Dec2020 and had some muscle spasms on Dec2020, but it was gone after two (2) days. On Saturday (09Jan2021), she got her second shot and she was in a giant muscle spasm from head to toe. It was like a whole-body Charlie horse that won't quit, and it hurts. It started three (3) hours after the shot and is not going away. It hurts and worked her up. The patient called to ask what she can request to treat the muscle spasm; a muscle relaxer? Patient didn't want to take anything that will counteract the vaccine. The event was reported as Non-serious. The patient recovered from muscle spasms on an unspecified date in Dec2020. information on the lot/batch number has been requested.
59 2021-01-24 pain in extremity, migraine Less than 24 hours after vaccine started stomach cramps, diarrhea and sore arm, next day ocular migr... Read more
Less than 24 hours after vaccine started stomach cramps, diarrhea and sore arm, next day ocular migraine(never had before) with flashing lights and severe headache, extreme fatigue, sore throat, felt terrible Had vaccine on Friday and by Monday, I felt recovered
59 2021-01-24 tingling, numbness On 1/18/21, 20minutes after receiving the shot, I started having numbness and tingling in my right ... Read more
On 1/18/21, 20minutes after receiving the shot, I started having numbness and tingling in my right arm, all the way down to my finger tips. it lasted for 10-20 minutes then slowly improved. This also happened after the first shot but I didn't think much about it because it only lasted for 3-5 minutes was mild and it was mostly just tingling.
59 2021-01-24 seizure On Jan 25th, 2021 patient went to the Covid clinic to get the first dose of covid vaccine at 5:50 pm... Read more
On Jan 25th, 2021 patient went to the Covid clinic to get the first dose of covid vaccine at 5:50 pm. After receiving the vaccine , patient was advised to wait at the waiting room to watch for any adverse reactions. Around 6:05 pm patient had a seizure and was around by the hospital staffs. The rapid response team came and took the patient to the Emergency Department on a wheelchair. Patent was alert when she left the Covid clinic.
59 2021-01-25 weakness, pain in extremity Achy legs/Sore arm; Weak and very tired; Weak and very tired; Slight headache; This is a spontaneous... Read more
Achy legs/Sore arm; Weak and very tired; Weak and very tired; Slight headache; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 14:45 at single dose for COVID-19 immunisation. Medical history included multiple sclerosis and Raynaud's phenomenon. Concomitant medication included natalizumab (TYSABRI) from 30Dec2020. The patient previously took and experienced allergies with celecoxib (CELEXIA), amoxicillin, desipramine and pantoprazole. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 21Dec2020 13:30 at single dose for COVID-19 immunisation. On 12Jan2021, the patient had achy legs. The patient was also weak and very tired that afternoon, with slight headache. She was much better on 13Jan2021. Her sore arm developed the day after vaccination after both injections lasted a day or two. No treatment was received for the adverse events. Clinical outcome of the events was recovered on Jan2021.
59 2021-01-25 feeling cold, tremor, pain in extremity headache, fluey, shaking and felt cold, deep muscle ache. Pt still has aching ,headache ,and sore ... Read more
headache, fluey, shaking and felt cold, deep muscle ache. Pt still has aching ,headache ,and sore arm.
59 2021-01-25 hot flush Extreme exhaustion, mental cloudiness, chills and hot flashes, diaphoresis, temp spikes, 99.5. norm... Read more
Extreme exhaustion, mental cloudiness, chills and hot flashes, diaphoresis, temp spikes, 99.5. normal temp is 97.6 to 98.0
59 2021-01-25 muscle spasms Muscle spasm and get hurt from head to toe; major muscle spasm; think if my husband touch me I would... Read more
Muscle spasm and get hurt from head to toe; major muscle spasm; think if my husband touch me I would kill him; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included Crohn's disease ("it's auto immune disorder in the digestive system"). The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization and was a little sore. On Saturday the patient got her second Pfizer vaccine (Covid Vaccine) and stated, "I feel like I am in a "giant" "terrible" (not clarified) because one time muscle spasm from head to toe. I think if my husband touch me I would kill him and I am taking a single. Just a major muscle spasm and I wanted to know, what should I tell my doctor to give me? Should I tell him to give me pain medication, muscle relaxers (Unspecified Medication)? Is it going to affect the effectiveness of the shot?" The patient took ibuprofen to try ease it out that didn't work. The outcome of the event was not recovered. Vaccination type facility was hospital. Information about Lot/Batch number has been requested.
59 2021-01-25 nerve pain nerve pain began in feet, arms and hands; This is a spontaneous report from a contactable healthcare... Read more
nerve pain began in feet, arms and hands; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration in the right arm on 08Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included ongoing ideopathic neuropathy and high cholesterol. Concomitant medications included duloxetine (DULOXETINE), acetylsalicylic acid (ASPIRIN BP), and simvastatin (ZOCOR). The patient experienced nerve pain which began in feet, arms and hands on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the event was not recovered.
59 2021-01-25 pain in extremity Patient reported experiencing extreme pain in her right arm approximately 4.5 hours after the inject... Read more
Patient reported experiencing extreme pain in her right arm approximately 4.5 hours after the injection which progressively became worse overnight. Limited mobility of right arm. Only with assistance and extreme pain can she move her arm above her head, in front of her outstretched, or behind her. Resting pain 2 days later still high at 6 and 10 with motion. Prickling sensations in her neck periodically as well. Taking 440 mg of naproxen for pain. 7 days later still in significant pain but slightly better. Migrating pain also now down the front of the arm, across the shoulder blade, and neck.
59 2021-01-25 tremor Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint ... Read more
Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint pain; Cough; feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 09Jan2021 11:00 at single dose for Covid-19 immunization. Medical history included asthma and hypertension. The patient received an unspecified medication in two weeks. The patient previously took codeine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pulsating headaches, blurry vision, nausea, 102.2 fever, body aches, hand tremors, dizziness, joint pain, cough, and feeling of exhaustion on 09Jan2021 (12:00 PM). There was no treatment received for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
59 2021-01-26 weakness Nausea, stomach cramps, fatigue, and weakness
59 2021-01-26 weakness nause, stomach cramps, fever blisters, lethargic, weakness
59 2021-01-26 feeling hot, discomfort VERBAL CONSENT OBTAINED, MONITORED FOR 15 MINPER POLICY, AT THE 15 MIN MARK PATIENT COMPLAINED OF M... Read more
VERBAL CONSENT OBTAINED, MONITORED FOR 15 MINPER POLICY, AT THE 15 MIN MARK PATIENT COMPLAINED OF MY BODY FEELS IMMEDIATELY TIRED AND WARM AN HEAVYBP 126/78 HR 74 POX 99 RA, KEPT FOR ANOTHER 15 MIN TO MONITOR
59 2021-01-26 numbness, burning sensation 1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20... Read more
1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20 and 1/21. 01/22/21 awakened at 4am with "head itching", dizzy, headache, numbness in arms, nausea. In the evening hives started on hands/back/legs. 01/23/21 Went to Urgent Care because hands "felt like I had them on a hot plate, burning".
59 2021-01-26 numbness, tingling Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for al... Read more
Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for almost 2 weeks , headaches, dizziness Completely normal on 1/22/21
59 2021-01-26 numbness, tingling NUMBNESS AND TINGLING IN CHIN, NOSEM JAWLINE, TO EAR ON RIGHT SIDE, AND LESS ON THE LEFT ALSO HAD T... Read more
NUMBNESS AND TINGLING IN CHIN, NOSEM JAWLINE, TO EAR ON RIGHT SIDE, AND LESS ON THE LEFT ALSO HAD TIGHTNESS IN THE BACK OF THE THROAT
59 2021-01-26 numbness Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pai... Read more
Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pain, diarrhea x2, nausea,
59 2021-01-26 migraine 14 hours later had 103 fever with chills, joint pain, migraine x 16 hours. The next day fever down,... Read more
14 hours later had 103 fever with chills, joint pain, migraine x 16 hours. The next day fever down, but has joint pain and dull headache.
59 2021-01-26 migraine severe arthralgias; migraine headache; mild nausea; This is a spontaneous report from a contactable ... Read more
severe arthralgias; migraine headache; mild nausea; This is a spontaneous report from a contactable nurse. A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142/expiration date unknown) dose number 2, via an unspecified route of administration on 08Jan2021 09:00 at a single dose on the right arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included asthma, arrhythmia, sulfonamide allergy, and latex allergy. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. Historical vaccine included BNT162B2 (COVID-19, lot number EJ1685, dose number 1) on 18Dec2020 06:30 on the right arm. There were no other vaccinations within 4 weeks. Concomitant medications included ASA, acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN), cyanocobalamin (VIT B12), ergocalciferol (VIT D), and cetirizine hydrochloride (ZYRTEK). The patient experienced severe arthralgias, migraine headache, and mild nausea on 08Jan2021 20:00. The outcome of the events was recovered in Jan2021.
59 2021-01-26 muscle spasms, pain in extremity, throat numbness Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest... Read more
Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day. Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-01-26 pain in extremity, tingling Vaccine was received at 7:12 a.m. on 1/26, I did not feel any adverse effects except for a sore arm... Read more
Vaccine was received at 7:12 a.m. on 1/26, I did not feel any adverse effects except for a sore arm until approximately 8:30 p.m. when I noticed the area of my upper neck and under my chin started feeling tingly and slightly numb. It is now 1/27, 7:00 p.m. and I still have a similar feeling. I have not noticed shortness of breath or major difficulty swallowing.
59 2021-01-26 tingling Immediate ear to throat throbbing, arms tingling, chest heaviness, extreme fatigue within 25 minute... Read more
Immediate ear to throat throbbing, arms tingling, chest heaviness, extreme fatigue within 25 minutes of injection, lasted approximately 30 minutes
59 2021-01-26 tingling My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later i... Read more
My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later it went away. But as it started to go away my lip was tingly and prickly.
59 2021-01-27 facial pain Covid vaccine- injection site pain; her face and neck is red like a sunburn; her face stings; This i... Read more
Covid vaccine- injection site pain; her face and neck is red like a sunburn; her face stings; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number not known) via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had been allergic to Bactrim since that age of 20 and she had she blisters on her lips. The patient had her first dose of Pfizer Covid vaccine on Monday, 11Jan2021 and after that in Jan2021, her face and neck were red like a sunburn. She said she had injection site pain, her face stings and it has been two days out. She wanted to know if she should get her second shot. The outcome of the events was unknown. Information about lot/batch number has been requested.
59 2021-01-27 pain in extremity, weakness achy legs/Sore arm; Weak; very tired; slight headache; This is a spontaneous report from a contactab... Read more
achy legs/Sore arm; Weak; very tired; slight headache; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration from 11Jan2021 at site of left arm at 14:45 at single dose for COVID-19 immunization. Medical history included multiple sclerosis and raynauds. The patient had known allergies: celecoxib (CELEXIA), amoxicillin, desipramine and pantoprazole. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and natalizumab (TYSABRI) from 30Dec2020. The patient received first dose of BNT162B2 with lot number: EH9899 on 21Dec2020 at 01:30 pm at site of left arm for COVID-19 immunization and experienced sore arm. The patient experienced achy legs at 06:00 on 12Jan2021, and weak and very tired that afternoon on 12Jan2021, slight headache. Much better 13Jan2021. Sore arm also developed on 12Jan2021. Facility type vaccine was in hospital. No other vaccine received within four weeks. No treatment for adverse event. No COVID prior vaccination. No COVID tested post vaccination. The outcome of events was recovered in Jan2021.
59 2021-01-27 pain in extremity, tremor I received my vaccine Tuesday @ 1300, I felt good Wednesday morning taking Motrin alternating with T... Read more
I received my vaccine Tuesday @ 1300, I felt good Wednesday morning taking Motrin alternating with Tylenol around the clock. At 1400 I felt achy with mild chills, at 1700 symptom were a lot worse. Shaking chills, temp 100, back, neck, and leg pain. I went to bed slept off and on. Woke up this morning, Thursday feeling a little better thought I could work but after getting to work symptoms got worse again.
59 2021-01-27 tingling Vaccine given in left arm. Tingling in left breast started yesterday and continues on and off today... Read more
Vaccine given in left arm. Tingling in left breast started yesterday and continues on and off today.
59 2021-01-27 unresponsive to stimuli Patient with inoperable pancreatic cancer received second Pfizer vaccine approximately 12:30 pm on 1... Read more
Patient with inoperable pancreatic cancer received second Pfizer vaccine approximately 12:30 pm on 1/27/21. At approximataely 16:30, patient complained of abdominal pain and was given Levsin 0.125mg and morphine 5mg orally. At approximately 19:30 patient was found on the floor covered in a large amount of emesis, unresponsive without a pulse.
59 2021-01-28 pain in extremity Back Pain and Arm pain
59 2021-01-28 pain in extremity This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-... Read more
This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK4176), via an unspecified route of administration in left arm on 14Jan2021 10:15 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Medical history included ''Known allergies: Penicillin; Bee stings; Red meat; seasonal''. No COVID prior vaccination. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO), ergocalciferol (VITAMIN D). The patient previously received first dose bnt162b2 (lot number= EH9899) via an unspecified route of administration in left arm at the age of 59-year-old on 28Dec2020 10:15 for COVID-19 immunization. The patient experienced severe body aches, severe headache, arm sore on 14Jan2021 21:00. No treatment received for the events severe body aches, severe headache, arm sore. No COVID tested post vaccination. The patient not received other vaccine in four weeks. Patient was not pregnant. The outcome of events severe body aches, severe headache, arm sore was recovering. The outcome of other event was unknown.
59 2021-01-28 tremor Elevated heart rate; Elevated blood pressure; Lightheadedness; Shakiness; This is a spontaneous repo... Read more
Elevated heart rate; Elevated blood pressure; Lightheadedness; Shakiness; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9261), via an unspecified route of administration on 15Jan2021, on 15:45 as the first single dose for an unspecified indication. Medical history included breast cancer from an unknown date, osteoarthritis from an unknown date, vasovagal syndrome from an unknown date, and sulfa allergy. Concomitant medication included ergocalciferol (VIT D), tocopherol (VIT E [TOCOPHEROL]), glucosamine (MANUFACTURER UNKNOWN), curcuma longa (TURMERIC). The patient previously took cefalexin (KEFKEX) and experienced drug hypersensitivity, levofloxacin (LEVAQUIN), and experienced drug allergy. The patient experienced elevated heart rate on 15Jan2021, at 16:00 with outcome of recovered with sequelae; elevated blood pressure on 15Jan2021, at 16:00 with outcome of recovered with sequelae in Jan2021; lightheadedness on 15Jan2021, at 16:00 with outcome of recovered with sequelae in Jan2021; shakiness on 15Jan2021, at 16:00 with outcome of recovered with sequelae in Jan2021. The patient recovered with lasting effects with no treatment. There was no Covid test post vaccination. The patient underwent lab tests and procedures which included blood pressure measurement and heart rate which were elevated in 15Jan2021.
59 2021-01-29 pain in extremity Temperature 99.7 F, chills, right arm pain
59 2021-01-31 feeling hot red rash; bruise; slight nausea; slight feeling of fever but temp registered normal; This is a spont... Read more
red rash; bruise; slight nausea; slight feeling of fever but temp registered normal; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number BNT162b2), at age of 59-year-old via an unspecified route of administration in left arm on 31Dec2020 11:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID), valsartan, rosuvastatin (ROSUVASTATIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient was not pregnant at Time of Vaccination. The patient experienced red rash, bruise, slight nausea, slight feeling of fever but temp registered normal on 12Jan2021 01:00 with outcome of recovering. The patient received topical antibiotic, diphenhydramine (BENADRYL) for treatment. The events resulted in doctor or other healthcare professional office/clinic visit.
59 2021-01-31 pain in extremity extreme arm pain---goes down to fingers. Also a general feeling of being "off" and dizzy spell/vert... Read more
extreme arm pain---goes down to fingers. Also a general feeling of being "off" and dizzy spell/vertigo post vaccination day 5.
59 2021-01-31 pain in extremity Lymphadenopathy, severe Left SI joint and low back pain, including Left leg down to foot. chills,hea... Read more
Lymphadenopathy, severe Left SI joint and low back pain, including Left leg down to foot. chills,headache, nausea, Ibuprofen every 12 hours with Tylenol in between. Warm compresses
59 2021-02-01 flushing I was in my car about 8-10 minutes after injection felt flush like feeing coming over me; felt nause... Read more
I was in my car about 8-10 minutes after injection felt flush like feeing coming over me; felt nausea and like I might faint, blew my horn on my car, Physician came over checked on me , EMT came over checked my pulse, 62, made me lie back in my car, could not get a blood pressure reading because of BP cuff. Brought me some cold water watched me for an extra 20 minutes I felt a bit better, drove home and laid down for a while. Felt nauseous and dizzy most of the day. I felt like either blood sugar or Blood pressure dropped. My blood sugar was elevated that day. I refused offer to go to ER
59 2021-02-01 pain in extremity Next day following 2nd dose of Pfizer vaccine, developed a sore left arm at the injection site. that... Read more
Next day following 2nd dose of Pfizer vaccine, developed a sore left arm at the injection site. that evening felt exhausted after work, fell asleep around 6:30 pm woke up around 8 pm and went to bed around 9:30 pm took Aleve for achy body. Friday morning, Jan 27th woke up with left arm pit and side of left breast swollen, tender to touch. and left arm very sore to lift up. Apply cold packs, taking Tylenol and area of tenderness lasting multiple days.
59 2021-02-01 pain in extremity Runny nose; allergies; sore arm; This is a spontaneous report from a contactable consumer (patient).... Read more
Runny nose; allergies; sore arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982), via an unspecified route of administration at the left arm on 14Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure (has had for 10+ years), ongoing high cholesterol (has had for 10+ years) and pulled a muscle in her arm on an unspecified date prior to vaccination. She received the vaccine because she is considered a front-line worker. She works for the department of Children and Family Services and must go into homes. She also adds that her mother in law was buried because she died from COVID. There were no concomitant medications. The patient received her first dose of the Covid-19 vaccine on 14Jan2021. She was fine other than a sore arm which started on 15Jan2021. On 19Jan2021, she has a runny nose. It is more like allergies. The outcome for the event sore arm was recovered on 16Jan2021; outcome for runny nose and allergies was unknown.
59 2021-02-01 seizure Resident had seizure activity
59 2021-02-02 weakness, seizure Reports she suddenly felt ill the morning of January 22, chills, weak, fatigue. Followed by what app... Read more
Reports she suddenly felt ill the morning of January 22, chills, weak, fatigue. Followed by what appeared to be a Grand Mal Seizure. Reports she has not had a seizure in 20 years. However writer found documentation of a seizure in 2014. Patient feels it was related to the vaccine.
59 2021-02-02 weakness My PCP advised I take benedryl and tylenol after the vaccine because of the AE I experienced to the ... Read more
My PCP advised I take benedryl and tylenol after the vaccine because of the AE I experienced to the 1st vaccine so I am unsure if because I was extra tired is d/t all of the vaccine or if the benedryl played a part in it. But about 2hr after I begin getting a headache but had already taken tylenol so I didnt take anything. I got a little dizzy and super sleepy but nothing else on the first day. The next morning I was so tired, drained feeling and very fatigued. I got up for a while but had to lay back down because I was feeling foggy, tired and very fatigued causing me to miss work. About 4pm I felt a little better. The next day I had a mild headache and still felt a little tired but was able to go to work and nothing else since.
59 2021-02-02 weakness Hi blood pressure, high blood sugar, weakness left side
59 2021-02-02 unresponsive to stimuli 45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilati... Read more
45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilating, increased B/P 200+/130+, decreased Responsiveness, tunnel vision, pin point pupils and no response to verbal and tactile cues For about 10 minutes. Transported to Hospital. Have Residual HTN.
59 2021-02-03 pain in extremity Temp 100; malaise; body aches; very sore arm; This is a spontaneous report from a contactable nurse ... Read more
Temp 100; malaise; body aches; very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK5730), via an unspecified route of administration (left arm), on 22Dec2020 19:00, at single dose, for covid-19 immunization. Medical history included asthma and; Covid (prior to vaccination). The patient has no known allergies. Concomitant medications included niacin; colecalciferol (D3); cyanocobalamin (B12); loratadine and; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). The patient was also taking ginger. The patient experienced temp 100, malaise, body aches, and very sore arm - all on 23Dec2020 10:00. The patient recovered from all the events on an unspecified date. No treatment was received for all the events reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination and; have not been COVID tested post vaccination.
59 2021-02-03 pain in extremity Fever, chills, body aches, headache, fatigue, arm soreness. Onset of mild body aches around 1:30 pm ... Read more
Fever, chills, body aches, headache, fatigue, arm soreness. Onset of mild body aches around 1:30 pm - 2:00 pm on 2/3/21 23 hours post COVID vaccine # 2. Symptoms worsened by 5:30 -6 pm. Highest temperature was 101.7. Took Tylenol and ibuprofen alternately. By 12pm 2/4/21 temp down to 99.1. Fatigue and residual headache remains. Other symptoms resolved.
59 2021-02-03 tenderness Woke with lymphadenopathy and tenderness left supraclavicular area
59 2021-02-03 tremor Symptoms: c/o dizziness, palpitations, tremors, chills. HR 132. Other vitals stable. Intervention: ... Read more
Symptoms: c/o dizziness, palpitations, tremors, chills. HR 132. Other vitals stable. Intervention: Rest, reassurance, warm water, HR down to 98. Stabilized.
59 2021-02-04 numbness, pain in extremity, tingling Pain , swelling very achy in ankles and knees for a few days. Later serious pain in hands and finge... Read more
Pain , swelling very achy in ankles and knees for a few days. Later serious pain in hands and fingers, numb feeling, tingling for about a week. Still have.
59 2021-02-04 numbness numbness on the left side of her face; very stressed; This is a spontaneous report from a contactabl... Read more
numbness on the left side of her face; very stressed; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she was having numbness on the left side of her face after receiving the first dose of the COVID-19 vaccine. She inquired about the symptoms in question and if Pfizer recommends receiving the second dose given her reaction to the first dose. She mentioned that she was very stressed about this symptom. The outcome of the events was unknown. The following information on the batch/lot number has been requested.
59 2021-02-04 numbness and pain in extremities severe generalized burning pain, tachycardia, elevated blood pressure, dizziness, chest pain, stomac... Read more
severe generalized burning pain, tachycardia, elevated blood pressure, dizziness, chest pain, stomach pain, headache daily starting on 01/06/2021 to 01/27/2021; moderate generalized burning pain, tachycardia, elevated blood pressure 1/27/2021 to now; daily use Cymbalta for neuropathy pain; Amlodipine for high blood pressure; undergoing cardiology evaluation, continuing neurology visits; pending endocrinology evaluation
59 2021-02-04 pain in extremity general pain in the arm for the first 2 to 3 days feeling of being unwell started 6 days after injec... Read more
general pain in the arm for the first 2 to 3 days feeling of being unwell started 6 days after injection date. no fever. just a feeling of general fatigue that lasted for 2 to 3 days
59 2021-02-05 numbness 2/4/21- nothing 2/5/21- chills and numbness in fingertips of left hand. Slept from 8:30am-10:30am ti... Read more
2/4/21- nothing 2/5/21- chills and numbness in fingertips of left hand. Slept from 8:30am-10:30am tingly went away but not congested 2/6/21 - no chills, no numbness but still congested, plus sore are which is expected
59 2021-02-06 difficulty speaking, numbness A minute after receiving the Pfizer COVID-19 vaccine, started feeling numbness on the right side of ... Read more
A minute after receiving the Pfizer COVID-19 vaccine, started feeling numbness on the right side of the body starting on my arm, minutes later, the sensation had extended up to my right leg and later to my right foot. Ten minutes after feeling this symptom, my right eye started feeling dizzy and shaking, also a feeling of chest pressure, it was hard to breathe normal, I had hoarseness and my throat was itching at the same time my blood pressure went up to 160/89 and tachycardia at 128. All these symptoms lasted for about one hour. After the hour the blood pressure went down some to 134/89 but the general sensation on my body is not back to 100% normal.
59 2021-02-06 flushing Extreme headache, nausea, body aches, flushed skin, swelling of face, diarrhea
59 2021-02-07 pain in extremity basically flu-like symptons: woke up with splitting headache-lasted approx 22hrs: tylenol 1000mg 2pm... Read more
basically flu-like symptons: woke up with splitting headache-lasted approx 22hrs: tylenol 1000mg 2pm, rizitriptan ODT 10mg 10pm , tylenol 1000mg 4:50am injection arm very very sore-hurt to move-lasted all day & night; woke up Sunday am not near as sore & could move. fever 2.2 degrees over normal ( normal 97.2 after injection 99.4) all morning; went down after took tylenol @ 2pm Sat, came back then went away in evening body very achey all day after/Sat.-back to normal next day/Sun
59 2021-02-07 throat numbness, tingling Patient began having "tingling" in fingertips within 30 minutes of vaccine. Numbness of tongue, roo... Read more
Patient began having "tingling" in fingertips within 30 minutes of vaccine. Numbness of tongue, roof of mouth, and back of throat started approximately 35 minutes later. No Shortness of Breath, Difficulty Breathing, or problems swallowing. Administered 50 mg Benadryl. Symptoms improved slightly, symptoms did not worsen. Observed for an additional 40 minutes. Went home with husband. Instructed to follow-up with 911 if symptoms worsened.
59 2021-02-08 weakness, pain in extremity, feeling cold, hot flush, muscle spasms Severe fatigue, headache in back of head, sore arm, extremely cold and loss of appetite first 2 day... Read more
Severe fatigue, headache in back of head, sore arm, extremely cold and loss of appetite first 2 days. Ongoing symptoms: waves of being hot/sweating, blurred visions, intermittent loss of taste and false sense of feeling of drowning or suffocating and/or breathing in heavy smoke, which last for a few seconds to a few minutes. diminished appetite, more easily fatigued, loss of energy. On February 8th, these symptoms began: feeling anxious, fatigued,sleepy, head feels spacey, slight headache, somewhat dizzy, intermittent buzzing sound in head, body aches, severe ache and muscle tenderness in left shoulder blade area down left arm, and muscle spasms in left shoulder and arm. Loss of taste again.
59 2021-02-08 pain in extremity Less than 72 hours after receiving the Pfizer vaccine for COVID-19 I had severe joint pains in my ri... Read more
Less than 72 hours after receiving the Pfizer vaccine for COVID-19 I had severe joint pains in my right hand up into my right elbow and swelling of all my right fingers except my right thumb. It took several days for the symptoms to clear and required that I take one PTO day since I couldn't type or hold a mouse.
59 2021-02-09 muscle spasms, cold sweat Charlie horses in legs; multiple cold sores on lip; Chills; Fatigue; headache; cold sweats; This is ... Read more
Charlie horses in legs; multiple cold sores on lip; Chills; Fatigue; headache; cold sweats; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unable to locate or read the details), via an unspecified route of administration on 19Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included psoriasis, high blood pressure, thyroid removal. The patient had no Known allergies. The patient other concomitant medications in two weeks included guselkumab (TREMFYA), levothyroxine sodium (SYNTHROID), aspirin (acetylsalicylic acid), bupropion hydrochloride (WELLBUTRIN), nebivolol hydrochloride (BYSTOLIC). Prior vaccination, the patient had not had COVID, not tested post vaccination. No other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 19Dec2020 at 12:00 PM at single dose in right arm for COVID-19 immunization. The patient experienced charlie horses in legs, multiple cold sores on lip, chills, fatigue, headache, cold sweats on 20Jan2021 07:00. The patient did not received treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Jan2021. The outcome of the events charlie horses in legs, multiple cold sores on lip, chills, fatigue, headache, cold sweat was recovered in Jan2021. Information on the Lot/Batch number has been requested.
59 2021-02-10 feeling cold, weakness, hypersensitivity of all senses, pain in extremity, tremor 7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks throug... Read more
7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks through left arm down to fingertips... 8:30- shooting shocks through left arm and starting to throb down through hand ... shooting up through next and base of head 9:00am- random shocks throughout my whole body. shoulder pain. 10:30- shocks stopped somewhat, shoulder and arm still achy, extreme fatigue/weakness, fogginess, blurry vision 11:30- extreme fatigue/weakness, fogginess, kind of blurry vision, severe shaking rt hand, had to sit down. Needed to hang on to things to walk. 12:00pm- continued severe fatigue and brain fogginess & still minor blurry vision, and a few shooting shocks in arm, shoulder , neck, 1:00pm? still great fatigue/weak, body aches-more like shocks than aches Neck is especially sore? back of neck up through head 1:10pm- severe fatigue, eyes hurt, foggy vision and cannot focus? off and on? chest pain for a period of time 1:40pm- twinges through body, still extreme fatigue? fogginess, back of neck is super sore.. Shoulder is slightly sore? 2:00pm- shoulder sore, severe fatigue but other symptoms seem to be getting less?. 2:45pm- shocks in left arm? 4:00pm- went home from work? hard to drive and focus.. severe fogginess, disorientation, 4:20- laid on the couch? slept in between nausea, buzzing in my head, severe arm pain going down into my hand, random shocks throughout my body, could not focus, brain was fuzzy, random severe itching, neck pain, eye pain, extremely irritable, extremely thirsty, bad taste in my mouth, extremely cold, no fever, super sensitive to sound & touch, no appetite, trouble peeing, felt extremely dehydrated. Needed to hang on to things to walk. Fri, Feb 5 6:00am- next day? better, but still buzzing, ringing in my head, extremely exhausted & weak, arm pain radiating to hand, hard to focus, coughing, chest heaviness like an elephant sitting on it, sore, scratchy throat, drainage out of head but not stuffed up?, eyes hurt. Severe nausea & bloating, rt hand shaking badly, no appetite 9:30am- everything is a bit better, coughing & chest discomfort gone, still bad taste in my mouth, slight nausea, bloated, eyes hurt, extremely tired, entire arm sore, buzzing in my head?random twinges or jolts in my limbs? 11:00am- still super tired, still not peeing?... weird for me who pees every 2 hrs or so? Still really bloated? still buzzing in my head, 1:30pm- feeling better, no buzzing, no zinging, super tired and drinking a lot but not much peeing? 4:00pm- home and bed.. hard to sleep because of jolts though my body.. Sat, Feb 6 Normal body aches.. finally able to pee decently, arm and hand on shot side sore (this is my good hand side), shooting pain, and hand aching. Fatigue, This has continued into Monday.. arm and hand pain are off and on. Everything is getting better?
59 2021-02-10 flushing Developed flushing of the cheeks and was a little lightheaded. She was brought to an observation roo... Read more
Developed flushing of the cheeks and was a little lightheaded. She was brought to an observation room from 5:15 PM to 6:15 PM and provided with water and snacks. The lightheadedness resolved with water and food. She was monitored closely for respiratory distress, stridor, tachypnea, and accessory muscle use which were not noticed or appreciated during this time period. Denied difficulty swallowing, shortness of breath, tongue swelling, redness, or any other systemic symptoms. By 6:15 PM, the flushing had greatly subsided. If the flushing remained when she arrived home, recommended taking benadryl prior to going to sleep. Advised to go to the ED should she develop shortness of breath, respiratory distress, tongue swelling, hives, and/or increasing redness to other parts of the body. She expressed understanding.
59 2021-02-10 pain in extremity Sore arm; Slight fever; This is a spontaneous report from a non-contactable consumer (patient). This... Read more
Sore arm; Slight fever; This is a spontaneous report from a non-contactable consumer (patient). This 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9262) via an unspecified route of administration on 25Jan2021 at 16:00 (at the age of 59-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. The patient had allergies to cashews and iodine. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen from an unknown date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient experienced sore arm and slight fever on 26Jan2021 at 9:00. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The reporter's overall assessment of the events was non-serious. The outcomes of sore arm and fever were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
59 2021-02-10 tenderness, feeling cold first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus... Read more
first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus shot. swelling, pain to touch and pain with movement or when positioned onto that side. decreased over 36-48 hours second injection 02/09/2020 306 pm received injection left deltoid. Awakened at 1237 am 02/10/2020 with chills, inability to get warm, headache, lightheadedness, sensation of heart pounding, nausea and moderate site tenderness. up most of the night. Nausea resolved about 10 hours after the symptoms resolved, remained without appetite. Fatigue, overall just tired, just not feeling well. temp max about 20 hours after onset of symptoms 101.5 temp broke when awakened from sleep in sweat at 327am 02/11/2020. on /2/11/2020 7am mild- moderate intermittent headache persists. Easy fatigue-as an example- fed cat took dog out and was tired and went back to bed.. Appetite better. felt better than I had on 02/10/2020, but not normal. Noted upon awakening is left axillary lymphadenopathy moderate and mild on the right- unable to press arms down to side as increased pain. also supraclavicular tenderness.
59 2021-02-10 tremor 12/16 vaccination 12/28 symptoms started to include; low blood sugar, shakiness, severe chills, hear... Read more
12/16 vaccination 12/28 symptoms started to include; low blood sugar, shakiness, severe chills, heart palpitations, low potassium. 2-3 hours symptoms lasted. Went to the ER; Oral potassium, juice to bring blood sugar up.
59 2021-02-10 tremor 1/5 vaccination later that evening; shakiness, heart palpitations, chills. Lasted for approximately ... Read more
1/5 vaccination later that evening; shakiness, heart palpitations, chills. Lasted for approximately an hour and then subsided.
59 2021-02-11 limb paralysis Report left arm stiffness and pain one month post injection. Treatment: Aleve; Outcome: Mild improve... Read more
Report left arm stiffness and pain one month post injection. Treatment: Aleve; Outcome: Mild improvement does not interfere with ADLs.
59 2021-02-11 tingling, pain in extremity, limb paralysis Excruciating pain in left arm starting at shoulder - no movement or feeling - weakness - numbness - ... Read more
Excruciating pain in left arm starting at shoulder - no movement or feeling - weakness - numbness - tingling
59 2021-02-13 weakness, feeling cold Aches and pains experienced during positive covid. Aches of necks and shoulder. Naseua and throwing ... Read more
Aches and pains experienced during positive covid. Aches of necks and shoulder. Naseua and throwing up. Weak and tired and cold.
59 2021-02-13 tingling Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1130 with symptom onset at 1135. Pt rep... Read more
Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1130 with symptom onset at 1135. Pt reported numbness in arm and shoulder of injected site (left), which progressed to the tip of her tongue and lips with a tingling sensation. Benadryl 25mg PO administered at 1155. Symptoms resolved after further observation.
59 2021-02-14 pain in extremity Naseau and vomiting commencing the following day and continuing for 24 hours; Naseau and vomiting co... Read more
Naseau and vomiting commencing the following day and continuing for 24 hours; Naseau and vomiting commencing the following day and continuing for 24 hours; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at 16:30 at single dose in Right arm for covid-19 immunisation. Patient was not pregnant.Medical history included allergies to cefalexin (KEFLEX), codeine and sulfa.Concomitant medication included escitalopram oxalate and omeprazole (PRILOSEC) . Patient experienced naseau and vomiting commencing on 28Jan2021 at 10:00 and continuing for 24 hours. On 28Jan2021 at 10:00 patient also had redness and swelling and acute pain at site of injection, aches and pains in arm radiating in back and shoulder.No treatment given. Final outcome of the events was recovering. Information on the lot/batch number has been requested.
59 2021-02-14 tremor Fever for 2 to 3 weeks 103, tremors, chills, sweats, headaches, bladder infection
59 2021-02-15 difficulty speaking Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing ... Read more
Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing was noisy. and noticeable" States breathing was not difficult but it felt like, "my chest was not right." About 12 hours later back to breathing normally. Tongue looks like all taste buds are gone on one section of tongue. Color is different than rest of tongue. Noticed metal taste on tongue on 02/11/2021 two days after vaccine. Food does not taste the same. Continues to have these concerns. 02/15/2021 chest was "pinkish, lacy redness." This was gone by 02/15/2021
59 2021-02-15 migraine After first dose, some discomfort in arm and low grade fever about 24 hours after administration. Af... Read more
After first dose, some discomfort in arm and low grade fever about 24 hours after administration. After second dose, approximately 12 -18 hours after, severe body aches, migraine headache which lasted for about 24 hours.
59 2021-02-16 weakness Weakness, fatigue, injection site sore, clouded thought process. Slept for 10 hours. Woke up to n... Read more
Weakness, fatigue, injection site sore, clouded thought process. Slept for 10 hours. Woke up to no other symptoms except sore arm.
59 2021-02-17 weakness 2/14/2021 felt faint and shaky, lasted approximately 30 minutes, very weak and tired after this, MD ... Read more
2/14/2021 felt faint and shaky, lasted approximately 30 minutes, very weak and tired after this, MD appt on 2/16/2021 (previously scheduled, not for this) had an abnormal EKG, right bundle branch block. No previous heart problems, no family history of heart problems.
59 2021-02-17 facial paralysis, nerve pain Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blu... Read more
Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose
59 2021-02-17 feeling cold, migraine 2nd vaccine - major chills, 101 fever, migraine, joints are super achy, hard to bend my fingers, inj... Read more
2nd vaccine - major chills, 101 fever, migraine, joints are super achy, hard to bend my fingers, injection sight red swollen and warm to touch, eyes burning
59 2021-02-18 migraine 7 hours after injection body aches progressed over 3 hours to pain in all joints. Shivering, rigors,... Read more
7 hours after injection body aches progressed over 3 hours to pain in all joints. Shivering, rigors, fever 101.3. Then 12 hours after injection sever migraine and nausea lasting 12 hours. 48 hours later diarrhea for 8 hours.
59 2021-02-18 tingling, burning sensation reaction to that of shingles. headache, nausea, burning/tingling sensation one side of body with sma... Read more
reaction to that of shingles. headache, nausea, burning/tingling sensation one side of body with small breakout and pain in breakout area. this began approx. 2 weeks after last covid 19 dose.
59 2021-02-18 throat numbness Pfizer-BioNTech COVID-19 Vaccine EUA. Approximately 30 minutes after shot, got a very bad taste in t... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Approximately 30 minutes after shot, got a very bad taste in the mouth, then throat became numb and I could not swallow unless I really forced it. I had to drink to be able to swallow. Again had to really try before I could. Then roof of mouth, back of throat and back of tongue felt number as if I had novocaine. The lack of swallow lasted about 10 minutes of forced swallowing. The numbness continued for about 2 hours but I was able to do everything. The numbness was more of an annoyance.
59 2021-02-20 migraine, tingling Migraine onset with increase in nausea, followed by my throat feeling tight and painful, mouth irrit... Read more
Migraine onset with increase in nausea, followed by my throat feeling tight and painful, mouth irritation , tingling. Parts of body started to itch intensely, then upper right side of face and forehead started to itch and tingle. Whilst on the phone to a nurse, I took 50mg of Benadryl. The symptoms seemed to stop getting worse for a short time (after about 15 minutes) but then started to get worse again, especially throat, right at the base. And face itching and tingling spread to neck. At the nurses instruction, I went to the closest ER, where they eventually examined me and some time after that gave me Prednisone and Pepsid. The symptoms further subsided after about 30 minutes but I was not check on for another 90 minutes. I was experiencing a lot of anxiety once I arrived at the ER and found the visit caused further anxiety. I was not experiencing anxiety prior to getting to the ER except for a little concern over the symptoms. Over the next two days I experienced fatigue, which got much worse two days after the vaccination. I already suffer from fatigue and this was more extreme.
59 2021-02-20 pain in extremity I woke up with sore inflamed right arm.Slight headache ,fever and chills. Took some Tylenol 2 tabs o... Read more
I woke up with sore inflamed right arm.Slight headache ,fever and chills. Took some Tylenol 2 tabs of 325mg tabs.
59 2021-02-22 pain in extremity With my second shot after eight hours of no symptoms, I had a fever of 101.8 and slept in a very dee... Read more
With my second shot after eight hours of no symptoms, I had a fever of 101.8 and slept in a very deep sleep for 48 hours. I woke to drink water and use restroom only. On Monday morning I woke up soaked in sweat that smelled like vinegar and the fever was gone. My first shot I had a little soreness in my arm only.
59 2021-02-23 difficulty speaking nausea, vomiting, hoarse throat, diaphoresis
59 2021-02-23 flushing small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushe... Read more
small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EL1284, expiry date: 31Apr2021), via an unspecified route of administration on the left arm, on 15Jan2021 09:30, at single dose, for covid-19 immunization. Medical history included heart issues from an unspecified date, cardiac ablation in 2020, total knee replacements on 2001 (approximately 20 years ago) and 2009 (approximately 12 years ago), spinal fusion surgery in 2017 (3 fused disc in her back approximately 4 years ago). Concomitant medication included cortisone which started on 21Jan2021 (as reported, pending clarification) for an unspecified indication. In Jan2021 (reported as "Saturday morning"), the patient experienced small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired. She was calling because she didn't know if it was possible if she could be having a reaction. She stated she had one other symptom, her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too. Treatment for the events small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired included Mucinex Night Shift Cold and Flu syrup, Halls Relief lozenges and Advil. The patient reported that her symptoms have stayed about the same. The patient took her temperature on an unspecified date and reported that it was fine. She reported she did not any lab tests done for the events. The outcome of the events was not recovered.
59 2021-02-23 pain in extremity soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest l... Read more
soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest level); tightness in chest (no productive cough); This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 10Jan2021 09:00 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital and not in a military facility. Medical history included asthma. Concomitant medications included albuterol [salbutamol] from unspecified date for unspecified indication. Historical vaccine included flu shot in Oct2020 for immunization and experienced some soreness in arm and achy. The patient was not given other vaccines given the same day or 4 weeks prior. In Jan2021, the patient had some soreness in arm and achiness (Jan2021) after the Pfizer BioNTech Covid-19 vaccine it didn't last long and she went to work afterwards. The patient was scheduled for work the next day and could tell something was not right. The patient was flushed and thought it was from the Albuterol since it can cause a racing heart beat and checked for a fever and didn't' have one. The patient checked temperature before bed and it was 100.5 degrees and she went straight to (redacted). The patient informed that she went for Covid testing; she went to physician office for Covid testing. The patient was praying for the flu so she could take Tamiflu and the flu test was negative (21Jan2021) and the Covid testing was positive (21Jan2021). The patient was tested positive after first Covid vaccine and ran fever 8 to 9 days and highest temperature was 101 degrees, had a little bit of asthma and kept a close watch, congestion, pulse ox 92 (lowest level), tightness in chest (no productive cough), felt beat up, fatigued and tiredness. The patient was diagnosed with Covid-19. She was told as well not to take pain relievers (ibuprofen, Advil and Aleve) and was advised to take Tylenol instead. The patient informed that she was to get her second dose tomorrow. The patient wanted to know if she can get the second dose if she was tested positive. The patient was supposedly scheduled to have the second dose on 27Jan2021 however it was moved to 04Feb2021 due to tested positive of Covid and was put on quarantined. The outcome of the events was recovering. The patient was unable to provide seriousness criteria when queried and said that this was her luck of the draw. The patient thought the shot actually helped.
59 2021-02-23 tingling, weakness Tingling in face, lightheaded, tired, feels "drunk", weak
59 2021-02-24 weakness Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen... Read more
Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen lymph glands right armpit; sore injection site; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 12:30, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included penicillin allergy, hypertension (HTN), obesity, hypothyroidism, iron deficiency anemia, s/p gastric bypass in 2010 (11 years), and GERD. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) included amlodipine benazapril, levothyroxine and pantoprazole. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0140, expiry date: unknown) received at 59 years of age, via an unspecified route of administration on the left arm, on 04Jan2021 12:30, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 01:00, the patient experienced fever 100-103, severe chills, body and joint aches, weakness, fatigue, swollen lymph glands right armpit and sore injection site. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The patient was recovering from the events.
59 2021-02-24 tingling, numbness injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swe... Read more
injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, nausea, feeling unwell, numbness and tingling in left hand thumb and pointer finger
59 2021-02-24 tingling Tingling in L arm that radiated to fingertips. Patient felt like it was anxiety related, refused to ... Read more
Tingling in L arm that radiated to fingertips. Patient felt like it was anxiety related, refused to be seen by EMS
59 2021-02-25 tingling Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes af... Read more
Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes after she received the vaccine and also started with a weird iron taste in her mouth, and tingling in her hands. She felt like she was going to pass out but got better after 20 minutes. The tingling in her hands continued though and would start and stop periodically.
59 2021-02-28 pain in extremity Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from... Read more
Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from a non-contactable healthcare professional (patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 22Jan2021 (12:45) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium, magnesium, vitamin d nos (CAL MAG), calcium carbonate;colecalciferol;phytomenadione (VIT D+K) and fish oil (OMEGA 3). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) on 30Dec2020 (when the patient was 59 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021, the patient had sore arm; insomnia; and chills in the evening ("eve"). On 23Jan2021, the patient had body ache, headache and tiredness. The patient did not receive any treatment for the events. The outcome of the events, 'sore arm', 'insomnia', 'chills', 'body ache', 'headache' and 'tiredness', was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.
59 2021-02-28 pain in extremity nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest o... Read more
nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest of the body; arm swelling and pain; arm swelling and pain / pain was more severe in the arm; This is a spontaneous report from a contactable health professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263,), via an unspecified route of administration on 26Jan2021 12:00 (at the age of 59-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included penicillin allergy, congenital heart defect. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) on 05Jan2021 at 16:00 (at the age of 59-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Jan2021 at 00:00 (on the 2nd day), the patient experienced arm swelling and pain. On 28Jan2021 (the 3rd day), the patient was nauseated, and the pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell. The events resulted in a doctor or other healthcare professional visit. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of arm swelling and pain, nauseated, pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell was not resolved.
59 2021-03-01 weakness racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break;... Read more
racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break; joints and bones felt like they were going to break; no appetite; weakness, unable to get up out of bed; unable to get up out of bed; patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 09Feb2021 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sjogrens disease/syndrome (immune disease), sulfa allergies. The patient's concomitant medications included several medications daily. The patient previously took morphine and experienced allergies and made her sick. Historical vaccine included first dose of BNT162B2, lot number EJ 1686 on 15Jan2021 for Covid-19 immunization. The patient has no Covid prior vaccination. On 09Feb2021 11:00 am (also reported as started 12 hours after 2nd shot), she experienced fever 103, hard chills, racing heart, headache, joints and bones felt like they were going to break, no appetite, weakness, unable to get up out of bed. The patient informed that the hardest time and highest fever was 11 PM to 6 AM Tue/Wed. The chills were severe, felt like her spine would snap into. The patient was still sick Wed (10Feb2021), the fever was not as high 101 to 102. The patient informed that what was scary was heart racing for hours that first night. The patient thought she was going to die. The patient informed that she didn't have heart problems, but she has Sjogrens, an immune disease. The patient informed that the fever was finally back to normal on Thursday (11Feb2021) afternoon after getting shot Tuesday noon. The patient informed that it's Sunday (14Feb2021) and she was still tired and has headache. The patient informed that it has to be something to do with Sjogrens. The patient informed that her rheumatologist said nobody so far had the kind of fever/reactions she had. The patient has not Covid tested post vaccination. The patient has explicit consent. The patient did not received treatment due to the events. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "racing heart" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
59 2021-03-01 migraine lightheadedness, migraine started. Waited extra 15 mins- Evaluated by EMS- Cleared
59 2021-03-02 weakness Weakness. Evaluated by EMS- Cleared
59 2021-03-02 discomfort Lightheaded, facial pressure, "feeling like something stuck in throat" - Evaluated by EMS-Cleared
59 2021-03-02 flushing, feeling hot 20min post vaccination patient complained of numbness of tongue, flushing, with hives on chest. Pat... Read more
20min post vaccination patient complained of numbness of tongue, flushing, with hives on chest. Patient was given 50mg of PO diphenhydramine and was monitored for 60 min. Refused call to 911. Flushing and warmth had abated and left clinic under own volition.
59 2021-03-03 numbness, tingling mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ t... Read more
mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ tingling in right fingers; This is a spontaneous report from a contactable healthcare professional. A 59 -year-old female patient (not pregnant at time of vaccination) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6201), via an unspecified route of administration (on left arm) on 18Feb2021 12:00 (at the age of 59-years-old), single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included levothyroxine, propranolol, omeprazole (PROTONIX), linaclotide (LINZESS). The patient previously took codeine, prednisone, dtap, had known allergies: Codeine prednisone and dtap. The patient experienced heart palpitation, face numbness, tingling finger, all on 18Feb2021 1500. Numbness in right cheek and tingling in right fingers and motto valve flare up, all on 19Feb2021, the events resulted in Emergency room/department or urgent care.No treatment given for adverse events. The outcome of the events were recovering. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination.; Sender's Comments: Based on available information, the Company considered all reported serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-03-03 numbness I had normal vaccine reactions that lasted for two days including significant body aches, unable to ... Read more
I had normal vaccine reactions that lasted for two days including significant body aches, unable to lift left arm without significant pain, and chills. The very unusual symptom was all TEN fingers (i.e. both hands) from the last joint to the finger tip went numb for 2 hours from 11:50 am to 1:50 pm. And then the numbness was gone. The numbness felt like the kind you get if you were outside on a below freezing day and let your finger tips go numb in the cold. However, I tried many techniques to try and get my fingers to stop being numb and nothing worked. The numbness resolved on its own after 2 hours.
59 2021-03-03 tremor shaky, nervous, palpitations. Evaluated by EMS-Cleared
59 2021-03-04 muscle spasms, tingling Tingling in Hands and Feet Blood Pressure Spike Nausea Cramping Dizziness / Lightheaded
59 2021-03-04 pain in extremity Severe pain in arm hard to control with ibuprofen, extreme chills, mild fever
59 2021-03-06 weakness Elevated HR, throat tightening, rash on chest and neck, dizziness and weak. Evaluated by EMS, transp... Read more
Elevated HR, throat tightening, rash on chest and neck, dizziness and weak. Evaluated by EMS, transported to nearest ER.
59 2021-03-06 tingling Tingling in upper lip, nose, hairline and right arm. Evaluated by medics-cleared
59 2021-03-06 tremor, weakness Pfizer-BioNTech COVID-19 Vaccine. 3/4/2021 pain in left are moving up arm from injection site, acros... Read more
Pfizer-BioNTech COVID-19 Vaccine. 3/4/2021 pain in left are moving up arm from injection site, across back shoulders, and down right are above elbow from 3/4/2021 at 6:00 pm through current time (3/7/2021 at 10:30 am.). 3/5/2021 at 10:00 am to current time (3/7/2021 at 10:30 am.) Burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones. Overall weakness and tiredness throughout body. Slight headache begins and feeling unwell at 3/5/2021 at 10:00 am. 3/6/2021 at 8:00 a.m. through 3/7/2021 at 8:00 a.m. Dizziness and weakness, tiredness, severe/excursiating headache/ muscle pain/chilles/fever/feeling unwell/severe ringing in ears/unable to get out of bed. No relief from advil pain reliever. 3/6/2021 at 5:00 pm nausea added to all symptoms above last 2 hours. 3/7/2021 at 8:00 am to current time (3/7/2021) Able to get out of bed. Headache managable, dizziness presists, weakness/shakey/, minimal energy/burning underskin is still occurring but reduced in level somewhat. Muscle pain in arms/shoulders/back torso and chills is occurring but at a reduced level.
59 2021-03-06 tremor SOB, shaky, pale, cleared by medics.
59 2021-03-07 weakness Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest ... Read more
Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest and neck. PB was elevated, dizzy, weak. Symptoms escalated quickly. Immediately flagged help from nearby medic.
59 2021-03-07 pain in extremity Swelling under are, size of 1/2 baseball. Sore and painful. Resolving
59 2021-03-07 pain in extremity Pain and soreness in left arm as if punched hard.
59 2021-03-07 pain in extremity Within 2 minutes I immediately broke out in hives on inside right forearm. I started with one and h... Read more
Within 2 minutes I immediately broke out in hives on inside right forearm. I started with one and had about 5 total (unsure of exact number but those I could physically see) on both left and right arms. Went away within one hour and also within the hour took 12.5 mg. antihistamine. However 24 hours after had pain (felt like bruising) on site of first hive which has continued since then.
59 2021-03-07 tingling, flushing flushing, tingling both arms, HA. Evaluated by EMS-Cleared
59 2021-03-08 weakness Profoundly weak by Saturday the day after the injection (2/6/2021), hospitalized by Monday (2/8/2021... Read more
Profoundly weak by Saturday the day after the injection (2/6/2021), hospitalized by Monday (2/8/2021), on a ventilator by Wednesday (2/10/2021) and died the following Monday, (2/15/2021) She was treated for HLH (hemophagocyticlymphoistiocytosis)
59 2021-03-08 weakness Approximately 28 hours after receiving the vaccine, I became very dizzy, to the point that my head w... Read more
Approximately 28 hours after receiving the vaccine, I became very dizzy, to the point that my head was spinning so fast I would pass out. When I would wake up, I was so nauseated that I tried to throw up but hadn't eaten anything, so I had dry heaves. I would wake up and repeat this process over and over. After about 6 hours the dizziness got better but I could not walk by myself as I was so wobbly and weak. My husband tried to get me to the car to take me to the ER but I couldn't stand up. I felt a little better the next day (Sunday) but was unable to keep anything down. I slept a lot as I felt exhausted. I was unable to work on Monday or Tuesday as I was still very disoriented. I would periodically had dizzy spells where I thought I was going to pass out, so when I went back to work on Wednesday, my husband drove me to work and picked me up. At work, when walking I still was very unsteady on my feet and kind of had to hold onto the wall to keep my balance. This stayed with me thru the next week. I felt better the following week and have not had any other issues.
59 2021-03-08 night sweats Vomiting, Diarrhea, night sweats, chills, low grade fever, fatigue, nightmares
59 2021-03-09 numbness having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; ... Read more
having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; Headache; having issues with her right hand being numb/1st 2 fingers on her right hand were numb; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 01Mar2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date was not reported) (at 59 years of age), via an unspecified route of administration in the right arm on 20Feb2021 15:49 at a single dose for COVID-19 immunisation. The patient's medical history and family medical history were none. The concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, 1st dose, lot number: EL9263, injection in right arm on 30Jan2021 (at 59 years of age). There was no other vaccines administered on same date with the Pfizer vaccine and there was no any other vaccinations within four weeks prior to the first administration date of the vaccine. The patient stated that she is not an HCP, but she does work in a mental health. She stated that she is concerned. She got her 2nd dose of the vaccine on Saturday and was having weakness in her right hand and arm. She asked if this was expected. She added that when she got up yesterday, her right arm was really sore, she was extremely tired, and she had a headache. She went to bed early that night at around 5:30pm, and she woke up around 8 or 9pm that night and tried to pick up her phone and couldn't. She stated that the 1st 2 fingers on her right hand were numb. When she got up today it was fine. They are working from home, so she was typing some notes and then it felt like her fingers went numb, it felt like her 1st finger was like rubber. She stated that the numbness comes and goes. She mentioned that she doesn't have a headache right now, but it felt like it could come back. The events did not require emergency room or physician visit. On 01Mar2021, it was reported that the patient was having issues with her right hand being numb and the representative that she spoke with recommended she follow up with her PCP, which she did, and they diagnosed her with having a small stroke and also referred her to a neurologist as well. She said that her primary care provider she saw was a nurse practitioner. She said that she also saw a neurologist. It was not reported if the patient received treatment for 'having a small stroke' while no treatment received for all other events. The outcome of having a small stroke was unknown; 'weakness in her right hand and arm' was not recovered; while 'Right arm was really sore' and 'really tired' was recovering. The outcome of Headache and 'having issues with her right hand being numb/1st 2 fingers on her right hand were numb' was recovered on an unknown date.
59 2021-03-10 breast pain I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and ... Read more
I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and tissue expanders are still in place. I reached a fever of 103.6 and had pain and extreme redness in my right tissue expander. I also had all axillary lymph nodes removed from that side in December 2020. On Friday I was still feeling ill and noticed redness, so I immediately contacted my doctor and was instructed to meet him at the hospital. I was admitted and placed on antibiotics and had my tissue expander removed The next morning after no improvement from antibiotic infusion. I had a wound vac placed and stayed in the hospital for one week and had my expander replaced on that following Saturday. I am not planning on taking the second shot.
59 2021-03-10 flushing Within five minutes of getting the vaccine I felt the front of my neck/throat had something like pre... Read more
Within five minutes of getting the vaccine I felt the front of my neck/throat had something like pressure/pressing/swelling. I kept swallowing and it didn't feel like my throat, more like between the outside of my throat/esophagus and skin...in the position where a man's Adam's apple would be, or possibly where my thyroid is. I got flushed, but I could breath ok. I felt odd, but I think I may have been panicking, I don't know. I drove home and saw that my face, neck, chest, even my thighs, were slightly flushed. I took my temperature throughout the evening. I am normally a low temperature of 97.6. It went up to 99.9. The second day my temperature was in the low 98s. However, by second day the roof of my mouth where it meets the throat felt odd, like if you burned it by eating something hot. Third day, today, I woke up and my temperature was only 95.2. I kept taking it, and then used my daughter's thermometer as well. It stayed low for several hours. I also had several bouts of diarreah this morning. Temperature came up into the 98s again. None of this is life threatening, but I still feel the weirdness in the front of my neck. I've never heard of that side effect so it upset me and scared me. I can handle the fever also, but the low temperature also scared me.
59 2021-03-10 migraine Pfizer-BioNTech COVID-19 Vaccine EUA Woke up with severe pain in my joints, very tired, all over bod... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Woke up with severe pain in my joints, very tired, all over body aches, migraine and the chills for 2 days and sore/red/hard/hot/raised injection site. On third day the chills went away and I was feverish, but still had all the other symptoms. This lasted one more day. I still have the sore/red/hard/raised injection site, but the other symptoms finally went away.
59 2021-03-10 pain in extremity I woke up early the next day 3/10/21 nauseous and with diarrhea. I was tired and had a mild headach... Read more
I woke up early the next day 3/10/21 nauseous and with diarrhea. I was tired and had a mild headache. My arm hurt moderately where the injection site was, but also on the inside of my upper arm. I felt lethargic and nauseous the rest of the day. I did not sleep well. Then 3/11/21 I woke with a mild headache and some nausea, but also severe pain on the inside of my upper arm. It was very sensitive all up to my shoulder on the underarm area and somewhat on the side of my ribcage, but then also radiating down to my wrist. This pain persisted until I am writing this form, approx. 2pm 3/11/21. It has not subsided at this point.
59 2021-03-10 pain in extremity I started that day with a thick throat and sore throat. No SOB. The next day it evolved into body ... Read more
I started that day with a thick throat and sore throat. No SOB. The next day it evolved into body aches, joint aches, headache, fatigue, and nausea. The next night I started vomiting. I felt like I had the flu. These symptoms persisted 3-4 days. The sore throat lasted maybe a week or more. No fever at any time. Had the usual arm soreness start the evening of the vaccine, much more than any other vaccine I've received. The arm soreness awakened me at night if I rolled over. FYI: I received the 2nd vaccine 2/4/2021 and only had a sore throat and sore arm.
59 2021-03-10 tingling Distal tingling x 4 extremities, swelling, erythema of posterior pharynx, able to swallow saliva, no... Read more
Distal tingling x 4 extremities, swelling, erythema of posterior pharynx, able to swallow saliva, no tongue, lip or facial swelling, heart rate 90, respirations 16, lungs clear, 50 mg of Benadryl administered IM right deltoid at 11:33 AM with good effect, transported to the Medical Center via ambulance with advanced life support capability at 11:52 AM.
59 2021-03-10 tremor, muscle spasms Having uncontrolled shaking and spasms of the legs
59 2021-03-12 facial paralysis 30 minutes after injection temporary paralysis of face lips and tongue. Partially resolved after 5 m... Read more
30 minutes after injection temporary paralysis of face lips and tongue. Partially resolved after 5 minutes fully resolved after 3 hours
59 2021-03-12 pain in extremity initially sore arm that went away; few days later headache, rash on face which developed gradually. ... Read more
initially sore arm that went away; few days later headache, rash on face which developed gradually. could be reaction to mask or vaccine not sure. been very noticeable the last 2 days. bright red by nose and mouth not really on forehead or anywhere else, does not itch
59 2021-03-13 discomfort 6 hrs- whole left arm heavy, sore deltoid, fatigue 18 hrs- Day 2 moderately severe headache, stiff n... Read more
6 hrs- whole left arm heavy, sore deltoid, fatigue 18 hrs- Day 2 moderately severe headache, stiff neck, heavy appendages x 4 as if concrete, elbows, wrists and knees ache, but low back pain worse, shivers, cold/hot feeling off and on, sleepy Day 3- headache 50% better, neck quite stiff still, low back pain but joints better. Still fatigue, anorexia.
59 2021-03-13 nerve pain, numbness, pain in extremity Pfizer-bioNTech COVID-19 vaccine EUA Numbness/pain (nerve pain) in left ring finger then pinky. Ner... Read more
Pfizer-bioNTech COVID-19 vaccine EUA Numbness/pain (nerve pain) in left ring finger then pinky. Nerve Pain on top of left wrist. Jaw stiffness, burn and scratching in throat.
59 2021-03-13 pain in extremity Fever, chills, headache, sore arm, achey body
59 2021-03-14 pain in extremity, tremor, cold sweat, feeling hot Day of vaccine my arm was sore and I had a slight headache and my heart rate felt fast but I think ... Read more
Day of vaccine my arm was sore and I had a slight headache and my heart rate felt fast but I think my heart rate was due to anxiety about the vaccine . That was until Friday morning. I woke up on the 5th at around 1 am shaking . Then got the cold sweats and chills and then burning up and body aching. Then I started throwing up. I started taking some IBProfen which helped with the fever and shakes. Stayed in bed all day and drank water. My heart rate was up to 122 bpm while I was laying on the couch. I was tracking it with my Apple Watch. I stayed on the couch for the next 2 days and Sunday I started feeling better. Each day I was feeling better but now almost two weeks out I still get slight headaches off and on, I have no energy and get the chills and my chest has a heavy feeling. But I don?t feel short of breath. I took a rapid covid test today 3/15/21 and the results were negative for covid and the flu. I am going to see a doctor on wed. as I am not sure I should get the second dose.
59 2021-03-14 pain in extremity 03/04/21 - pain, swelling, redness , left arm 03/05/21 - pain, swelling, redness , left arm, fever... Read more
03/04/21 - pain, swelling, redness , left arm 03/05/21 - pain, swelling, redness , left arm, fever 101 03/06/21 - pain, swelling, redness , left arm, fever 100 - 101, fever varied 03/07/21-03/14/21 - itchy left arm , pain left arm, fatigue, loss of appetite, dizziness 03/15/21 - fatigue, dizziness, general body aches
59 2021-03-14 tingling, burning sensation I have allergies and it feels like allergic hypersensitivity, which I had before when my allergy sho... Read more
I have allergies and it feels like allergic hypersensitivity, which I had before when my allergy shots were missed a year or so ago. Burning and tingling feeling in legs, torso, neck basically where clothes touches or rubs. Some tingling sensation on tongue as well. I stayed after 20 minutes after the vaccine because of I have allergies. After I left and got into my car to drive away I started having the burning feeling in my legs, torso and tingling in lips and tongue. I work for the ED group, so I drove over and stayed by the entrance until I felt like it was not getting any worse. I waited for about an hour. I though the burning sensation would go away, but it has not. I called my allergist and he advised I should contact you and report via this source.
59 2021-03-15 feeling hot Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation ar... Read more
Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation area when she started to experience a racing heart-rate and warmth. The patient was brought water, juice, and tried to relax. Patient was stable but after drinking juice started to feel swelling of the tongue and itching around the neck. Patient was given more water and a diphenhydramine capsule. Tongue swelling and itchiness decreased and the patient went home with her husband after improving. Total course of observed reaction was around 1 hour.
59 2021-03-15 pain in extremity Feeling of "unsettled " "anxious " feeling of doom " "depressed". Sore arm
59 2021-03-15 pain in extremity I had my first shot of the COVID vaccine last Friday, March 12. On Saturday I realized my vertigo wa... Read more
I had my first shot of the COVID vaccine last Friday, March 12. On Saturday I realized my vertigo was back more intensely than I have had it before. A few people I talked to said they had light-headedness or some dizziness as a side effect. Didn't think too much about it as I have had vertigo symptons on and off for at least 10 years. I figured it had to do with my ears and the constant ringing I hear in my ears. Sometimes when I roll over in bed the room will spin for a few seconds. After this Friday, the room spins a lot longer and faster. I have to make sure I am balanced when I stand up and just tilting my head can cause me to feel unbalanced. I am being careful and it is not stopping me from functioning. Just thought I should report it to someone. I am hopeful that it will go away as it usually does. Other than a sore arm the first night...this was the only side effect I have noticed. If you have any suggestions to help please let me know. Otherwise just letting you know.
59 2021-03-15 pain in extremity 5 days later got sore arm and some redness around injection site (like a small rash) no itching, I p... Read more
5 days later got sore arm and some redness around injection site (like a small rash) no itching, I put ice on it and took Aleve
59 2021-03-15 tingling Small area (6? round) of itchy rash on stomach which resolved after a few hours. Tingling of itchin... Read more
Small area (6? round) of itchy rash on stomach which resolved after a few hours. Tingling of itchiness on various locations of body.
59 2021-03-15 throat numbness Patient states my throat feels numb, rashes noted around neck and chest. Patient evaluated by parame... Read more
Patient states my throat feels numb, rashes noted around neck and chest. Patient evaluated by paramedics on site. Monitored patient for 30 minutes. Patient referred to ER due to elevated BP. Patient refused and signed AMA. Patient A&O x3, accompanied by husband.
59 2021-03-16 weakness Persistent weakness/lethargy post vaccination observation period; transported to ED
59 2021-03-16 numbness, tingling, feeling cold, night sweats I tested positive for Covid on November 11th 2020,and was asymptomatic. Within 48 hrs of getting t... Read more
I tested positive for Covid on November 11th 2020,and was asymptomatic. Within 48 hrs of getting the vaccine both my right hand and right leg started tingling and I had pins and needles sensation. I also woke up in the middle of the night with immense night sweating. My arm started becoming numb and cold. I talked to a doctor and she suggested I go to the ER right away as this could be indicative of a minor stroke. I was admitted in the hospital as they needed to run several tests. I spoke with other doctors who suggested not taking the 2nd shot as it could make matters worse. So I opted out of taking the 2nd jab. I wonder if there is any study about adverse reaction for former Covid positive people and if they are better of only taking the 1st jab. Another Covid positive friend also had a similar reaction after the 1st jab. His right side of face became numb. I am worried about lasting damage if any. Could somebody please get back with me on this.
59 2021-03-16 numbness Per staff member, HCP, that attended to patient in observation area: " post covid vaccine note. Pt ... Read more
Per staff member, HCP, that attended to patient in observation area: " post covid vaccine note. Pt received vaccine at 1120am, 1125 while in chairs pt felt dizzy with left arm and leg numbness. Pt alert, skin warm and dry. Placed on stretcher and brought to obs area. 120/77 99% on 2 liters 76 16. Remains alert, dizziness and left extremity numbness persist along with facial numbness, bilat. No facial droop, PERL midline grasps equal. 911 called. 124/71 76 16. EMS arrived, assessed pt and decided to trans to hospital. Pt and husband agree and understood plan. Pt anxious at this time but remains alert but unable to raise left leg, speech slightly slurred. Pt left clinic via ambulance about 1155am with belongings"
59 2021-03-16 pain in extremity Received first vaccine on Saturday at 11:00 am. Sunday had a sore arm. Took 1000mg Tylenol and felt ... Read more
Received first vaccine on Saturday at 11:00 am. Sunday had a sore arm. Took 1000mg Tylenol and felt better. Woke up Monday morning to a slight rash/hives on back of neck. Tuesday it seemed to be getting worse so I went to my primary Dr. He prescribed Clobetasol cream 0.5%. He also said to take 25mg benadryl every 6 hours. Wednesday morning rash spread to shoulders and both arms. Called Dr and he prescribed a taper of prednisone.
59 2021-03-17 weakness headache; not feeling well; nausea; had a temperature of 100.4 and 100.2; weak and tired; weak and t... Read more
headache; not feeling well; nausea; had a temperature of 100.4 and 100.2; weak and tired; weak and tired; sinuses became very dry; This is a spontaneous report from a Pfizer-sponsored program, COVAX Support. A contactable consumer (patient) reported that a 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EM9809, expiry: 30Jun2021), via an unspecified route of administration on the left arm on 08Feb2021 at 16:45 (at the age of 59years) at 0.3 mL, single because she didn't want to get the virus and wants to get the world back to normal. Medical history included obese, prophylaxis (reported as she takes as extra precaution during winter) and abdominal discomfort (reported as stomach). Concomitant medications included cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, sodium ascorbate, thiamine mononitrate (ONE A DAY), montelukast sodium (SINGULAIR), lansoprazole for stomach, sucralfate, piroxicam (ZICAM) for she takes as extra precaution during winter, calcium and bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). Historical vaccine included flu shot and experienced arm sore and bed for the weekend (first time she got the flu shot she was in bed. It was kind of the same thing. Everyone said with the first vaccine it would make her arm sore. She was in bed for the weekend. She has had the flu shot five times in her lifetime. Subsequent flu shots she has been fine with. She doesn't have NDC, lot, and expiry for flu shot as it was at least 27 or 28 years ago). She received Pfizer COVID19 vaccine on Monday 08Feb2021 and her "sinuses became very dry" (in Feb2021). The patient experienced not feeling well, headache, nausea, temperature of 100.4 and 100.2 on 09Feb2021. During the night probably early on the ninth (09Feb2021) she got a headache, was not feeling well, and had nausea. When she got out of bed she had a temperature of 100.4 and 100.2. She thought that was a regular reaction to the vaccine. She didn't go to work. She felt weak and tired. She was told that was not usual for first but was for the second. She had slight headache the next day. She had a light headache for a few days. On Tuesday when she had the fever, she took paracetamol (TYLENOL, extra strength) and it wasn't getting rid of the headache. The fever came down a little. She wouldn't call what she had a big fever. She took ibuprofen (ADVIL, regular strength) later in the day. She normally doesn't take ibuprofen, but she did because she needed relief and paracetamol wasn't doing it. Since Wednesday, she might have taken one or two paracetamol a day. Once her sinuses started to dry out she started taking paracetamol. On Friday night her sinuses felt very dry and she was thinking it was all from the vaccine. She had a three day weekend. On Monday, she couldn't go back to work because she was nasally. Her symptoms began on 11Feb2021 and the health department had her quarantining for 10 days. The doctor said she should get tested and she was she then tested positive for COVID-19 on 12Feb2021. Apparently she picked it up coincidently. She couldn't figure where she picked up COVID. She tested positive. There was nothing concrete on when she can go back to get second COVID vaccine. She knows she couldn't be sick and symptomatic. She has to follow quarantine. The second appointment was on 01Mar. The patient asked if there was any guidance regarding when could she get the next dose and if she could return to work on 23Feb2021. Also asked if how long she could go without losing the efficacy of the first dose. She felt better today. She took the COVID test on Monday 15Feb2021. It was the PCR test. The results came in an email at 05:00 on 16Feb2021. The patient has been isolating in her bedroom. Her daughter was home. Her husband's company paid for him to stay in a hotel. She has felt good today and got on the treadmill. Usually she was a very active person. The facility was a state-run vaccine site. The patient had no previous immunization with the Pfizer vaccine, no additional vaccines administered on same date of the Pfizer suspect and no prior vaccinations within 4 weeks. The outcome of the events was unknown.
59 2021-03-17 coordination abnormal Approx. 8 hours after injection started having body aches within an hour developed a fever and becam... Read more
Approx. 8 hours after injection started having body aches within an hour developed a fever and became very lethargic. at midnight fever had reached 103, severe body aches and cold chills, used tylenol to lower fever but it continued up to 104. severe joint pain and when trying to walk had no muscle control. fever finally broke at 6pm the following day also experienced bright red face and headache.
59 2021-03-17 pain in extremity No symptoms immediately after first shot except after 13 days later woke up with pain in arm (same a... Read more
No symptoms immediately after first shot except after 13 days later woke up with pain in arm (same arm as injection). Pain is still present after 3 days. Taking ibuprofen, ben-gay, and heating pad with essentially no effect. If I keep arm elevated the pain is slightly less. Not able to sleep due to discomfort on Day 2 and was able to sleep on Day 3 although woke up at 2am and put on ben-gay and heating pad. Constant pain limiting mobility in arm.
59 2021-03-17 tingling Tingling along arms, back, sometimes legs that seems to occur shortly after eating. It subsides aft... Read more
Tingling along arms, back, sometimes legs that seems to occur shortly after eating. It subsides after a couple of hours
59 2021-03-17 throat numbness, tingling Tongue, gums and throat numb for 45 minutes, waves of of tingling numbness from my knees to my throa... Read more
Tongue, gums and throat numb for 45 minutes, waves of of tingling numbness from my knees to my throat every 10 minutes for about 45 minutes.
59 2021-03-17 tremor, tingling swollen lips, blurry vision, shaky, tingling. Evaluated by EMS- Transported to Emergency room/depart... Read more
swollen lips, blurry vision, shaky, tingling. Evaluated by EMS- Transported to Emergency room/department or urgent care.
59 2021-03-18 weakness (Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up ar... Read more
(Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up around 12 hours after having the vaccine and felt a strange sensation in my head, almost like a helmet of fog over my head, sort of a numb feeling, and I noticed that also my eyes and lips felt numb. I ate a grapefruit as I usually do (not sectioned by myself). I felt extremely lethargic, had joint pain and a weakness. I usually have tea and toast in the morning and as I was at the table buttering my toast, I had an overwhelming nausea come on. I then woke up on the floor. My companion told me I went unconscious and slipped off the chair. Perhaps the whole episode was a maximum of 20 seconds. My first words were "Where am I?" and my companion told me. I rest on the floor, directed my companion to read on the internet about stroke and we ascertained I was okay, so I was thinking completely clearly. In any case, I had the fog in my head the entire day, and also today, but I feel a little better and was able to eat after 4 hours of rest. I wasn't able to fall asleep but I rested the entire day and slept a couple of hours during the night, which is not like me. I usually don't have any problem sleeping.
59 2021-03-18 weakness Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on e... Read more
Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on energy for an hour or so; and then all of a sudden I can't even hold my head up; Eyes were swollen; Back to my head very weak; My whole body feels like it is bruised; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9262/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 17:30 (at the age of 59 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included rheumatoid arthritis. Concomitant medication included methotrexate 2.5 mg (8 tablets, once weekly), hydroxychloroquine 200 mg, 2x/day and folic acid UNK, 1x/day(1 tablet). On 12Feb2021 (Friday night), the patient reported that she "don't still feel good". The clinical course was as follows: On 12Feb2021, an hour after the receiving the vaccination, the patient reported "it started with pain in side in my head and within minutes it was like I was jelly. I was felt like fall on to the floor. I slowed down and I was extremely tired. I even left work early. I was off Saturday and Sunday. Today I could not even get work. It is like I have a burst on energy for an hour or so. And then all of a sudden, I can't even hold my head up. My eyes were swollen and back to my head very weak. My whole body feels like it is bruised. Treatment received for the events included ibuprofen. The consumer stated, "I took 4 on Saturday and later on like midday about 4 or 5 O'Clock. That was 200 mg each. It was total of 800mg." The outcome of the events was unknown.
59 2021-03-18 electric shock sensation About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my... Read more
About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my head feeling pressure like it was inflating and my brain feeling like it was short circuiting and doing alot of misfiring or something (hard to explain but it was like a lot of brain activity) which immediately led to my heart pounding and racing (I don't know if the pounding heart and racing was due to feeling panic because of my brain reaction or the vaccine). The metallic taste and brain issue subsided within a minute (perhaps less) but my heart continued to race for about 3-5 mins and then subsided with a tightness in my chest for nearly 3 hours.
59 2021-03-18 numbness Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and l... Read more
Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and lips and hardening of lymph gland in left chest. This lasted for hours. Injection site pain only lasted about 24 hours. Since then, I still have numbness on the right side top of head and intermittent EXTREME tinnitus that interferes with my ability to concentrate, communicate and sleep. It comes and goes but the volume is beyond anything I have ever experienced. Then it goes away. The right side of my head has stayed numb. Will this go away? Should I get the 2nd dose or not?
59 2021-03-18 night sweats Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and un... Read more
Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and under arm on the side where got the shot swelled up; hurt quite badly; huge swollen lymph nodes; Body ache; Could barely walk; could walk to shuffle my feet; joints stiff; Horrible headaches; Diarrhea; I was dizzy and foggy; Night I break out into a horrible sweat in night like I have to change my pajamas twice; I am like wet; Arm sore/My arm was just little bit sore; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot Number: EN6202) (at the age of 59) as a single dose, for covid-19 immunisation. Medical history included an unspecified heart condition and a flu shot un an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID) and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE). The patient stated, "I am calling about the side effects I had from my Covid shot vaccine. I am concerned about getting the second one because my reaction was so big. I got it on Saturday, this past Saturday about 12:45 I think 12:30 and I did fine, the shot didn't hurt at all. That night I was a little bit tired but that's it. My arm was just little bit sore. The next day I got up, I still felt good I went to work for 2 hours and then about 12 o'clock it hit me all at once. This Sunday I ran anywhere from a 103 to 104.6 fever and that was me taking Tylenol and I took Tylenol every 4 hour because my fever was still high. The glands in my neck and the glands under my arm on the side where I got the shot swelled up, they are still swollen. My whole body ached. I had Covid fairly bad I got pneumonia with it all for "two weeks" (not clarified) but my fever was not as high as got with the shot, the vaccine like I could barely walk after the vaccine because my joints were so stiff only way I could walk was to shuffle my feet, it was horrible. I had a fever yesterday all day but it was only in the 102.3 and 4, it never went back to 103. Glands in my arm and my neck hurt quite badly. My arm where I got it, it wasn't swollen but I get the same reaction when I get a Flu shot (unspecified shot) so that's not a big deal. I got horrible headaches. I had diarrhea all day Sunday and yesterday and so this morning my fever is only right around 101 like 101.1, 101.2, I am still super tired and also yesterday and day before I was dizzy and foggy. I still have a slight fever today. My lymph nodes are still swollen, my neck and under my arm, my arm where I got the shot is still swollen and sore but I can tolerate that. My joints are stiff a little bit but not nearly as bad as they were, so I don't know if I should get the second shot, everyone says the second shot is worst like all those heart palpitations start with it as well." One of my other symptom is at night I break out into a horrible sweat like I have to change my pajamas twice. It was last night and the night before. I am like really wet." The outcome of the events was not reported.
59 2021-03-18 pain in extremity, muscle spasms She was tested on 13Jan2021 and it came back positive the next day 14Jan2021; she was getting a cold... Read more
She was tested on 13Jan2021 and it came back positive the next day 14Jan2021; she was getting a cold; She also had a fever of 99.5; chills; sweats; she had lost smell and taste; she had lost smell and taste; That night she could not lift her arm. It was sore at first; That night she could not lift her arm. It was sore at first/Then she could not lift her arm; tired/she felt extremely tired; terrible left leg pain; leg cramps/more so in the left leg and then it turned into both legs/sporadic leg cramps; full body achiness; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported for herself that a 59-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 09Jan2021 (at the age of 59-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing prophylactic health. Concomitant medications included acetylsalicylic acid (ASPIRIN) at 81mg; calcium/colecalciferol (CALCIUM +D3) at 600mg; ascorbic acid, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon dioxide, sodium metavanadate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc (CENTRUM SILVER ADULTS 50+); colecalciferol (D3) at 200 units and elderberry gummies with vitamin c and zinc. All are ongoing and taken for prophylactic health. The patient had her first COVID Vaccine dose on 09Jan2021. She thought she was getting a reaction but ended up testing positive for COVID. She was tested on 13Jan2021 and it came back positive the next day 14Jan2021. She had questions about when and if she should get the second dose. She was referred to speak with her doctor and Pfizer does not have information for that. She got her first dose on 09Jan2021. That afternoon (09Jan2021) her daughter came home, and she had lost smell and taste. That night she could not lift her arm. It was sore at first. She was laying down and her husband asked if she needed anything, and she said no. Then she could not lift her arm. She was sure that was from the vaccine. That lasted until 10Jan2021 and then she was fine and has recovered completely. That same day on 09Jan2021, she felt extremely tired. That lasted about two weeks from the COVID. On 11Jan2021 that Monday, she had also felt like she was getting a cold, but she was not even really stuffy. She also had a fever of 99.5. The chills were setting in even without a fever. She was got, had chills and sweats. That night she went to bed and woke up about an hour later and had terrible left leg pain. Her doctor wanted her to get tested in case it was COVID. She had called him that Monday she thinks, 11Jan2021. He wanted her to go to the ER, not somewhere private, in case she did have COVID, but she did not want to go. She had the leg cramps for 3 days, more so in the left leg and then it turned into both legs. She also had her legs checked out and was negative for any DVTs. It was 3 days of sporadic leg cramps. They were so bad and mainly on her left side. It then turned into full body achiness after that. Caller says overall she was fine. The outcome of the events smell loss, taste loss, pain in arm, mobility decreased recovered on 10Jan2021, all other events was recovered on an unspecified date in Jan2021. Information on the lot/batch number has been requested.
59 2021-03-18 tingling, numbness Face numbing, mainly in cheek and eye area, eye twitching, eyes very dry, part of lip and chin. i... Read more
Face numbing, mainly in cheek and eye area, eye twitching, eyes very dry, part of lip and chin. it started off as becoming very tight, then the tingling. it has been over 24 hours and still sum tingling in the check bone and chin area.
59 2021-03-19 weakness sever loss of energy. bloodshot eyes
59 2021-03-19 weakness about 23 hours after the short I fell tired, weak, I got chills and a fever. That night while sleepi... Read more
about 23 hours after the short I fell tired, weak, I got chills and a fever. That night while sleeping I woke up to a pain under my arm (armpit) on the same arm as the injection. Later the next morning I had a red splotch on my arm (same as injection but not the same spot). The splotch is warm to the touch, and has a bump or hardening under the skin, it is also a little painful.
59 2021-03-19 weakness Extreme weakness. Walking was at a shuffle (24 hours) Sleeplessness. Hyper but couldn?t sleep for 3... Read more
Extreme weakness. Walking was at a shuffle (24 hours) Sleeplessness. Hyper but couldn?t sleep for 3 days. All resolved with no lasting effect. Please note - this was 2d dose. First was 6 weeks prior.
59 2021-03-19 hot flush Heart Palpatations Chest Tightness Coughing Chills Body Aches Hot Flashes Shortness of Breath Conges... Read more
Heart Palpatations Chest Tightness Coughing Chills Body Aches Hot Flashes Shortness of Breath Congestion Muscle/Joint Pain
59 2021-03-19 pain in extremity Sore arm Severe headache Nausea
59 2021-03-20 pain in extremity Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg b... Read more
Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg bright red spots appeared ,headache very bad,back of head hurting like a baseball bat had whacked it,
59 2021-03-20 cold extremities Ringing in my ears since a day after I got the shot , Have had the condition previously but this has... Read more
Ringing in my ears since a day after I got the shot , Have had the condition previously but this has been exacerbated significantly since the vaccine. Sensation in tip of my tongue. Left eye feels like it is a bit burry . Hands and feet very cold . Has gotten better after the 5th day. Was tired for 5 days after vaccine.
59 2021-03-21 feeling hot, flushing patient was feeling warm and flushed, she noticed her skin on her arms and chest were turning pink/r... Read more
patient was feeling warm and flushed, she noticed her skin on her arms and chest were turning pink/red. She reported that she has a sulfa allergy and had experienced something similar. Benadryl was given when she had taken the antibiotics and the physician said that was the only thing that "saved her bacon". Patient prefers to sit vs lay down. Felt, slightly nauseated and light headed. Gave alcohol prep to help with the nausea. IM Benadryl given per standing order. 50mg IM to Rt deltoid. Patient responded well to this and started to get normal coloring back and felt good enough to go home; declined evaluation offered by paramedics to hospital.
59 2021-03-21 numbness AT 0900, patient complained of left hand and finger numbness. Patient stated this has happened befor... Read more
AT 0900, patient complained of left hand and finger numbness. Patient stated this has happened before. Staff continued and to watch for additional 5 minutes. Patient went home after additional 5 minutes and told to go to the emergency room if any symptoms returned.
59 2021-03-21 pain in extremity Patient presents to urgent care 4 days afer 1st covid vaccine with chest discomfort, SOB, body aches... Read more
Patient presents to urgent care 4 days afer 1st covid vaccine with chest discomfort, SOB, body aches, arm pain. Mild vaccine reaction, follow up with PCP.
59 2021-03-21 pain in extremity Severe body aches, joint pain, muscle pain, fever (99.7), headache, extreme fatigue, sore arm (this ... Read more
Severe body aches, joint pain, muscle pain, fever (99.7), headache, extreme fatigue, sore arm (this began about Saturday morning 2:00 a.m.) fever was gone by 8:00 a.m. I had mild joint and muscle pain when I went to sleep Saturday evening, but when I woke up Sunday morning, all symptoms were gone. On Sunday evening, I began to get a throbbing headache that pulsed in my head all night. I was briefly nauseated when I got up Monday morning because of the headache. By 10 a.m. the headache was gone. I developed a slight rash and warmth at the injection site on Monday morning. As of 5:00 p.m. the rash is still there but the pain is lessening as is the warmth.
59 2021-03-21 tenderness Upper shoulder pain, pain running up from shoulder to the left side of neck towards the ear, no pain... Read more
Upper shoulder pain, pain running up from shoulder to the left side of neck towards the ear, no pain in the actual ear just in the neck. Underarm pain expanding into the left side of left breast. All pain was an aching pain with tenderness if touched. Took Tylenol for some relief. There was no redness or rash. Lasted about 2 days with heavy pain on day one and lighter pain on day two.
59 2021-03-22 weakness ?Fainting, ?body chills, ?fever, ?loss of appetite, ?weakness, ?sleepiness, ?headaches
59 2021-03-22 bell's palsy 15 minutes after vaccine was getting lightheaded and little dizzy. Then 30 minutes after ( now 45 mi... Read more
15 minutes after vaccine was getting lightheaded and little dizzy. Then 30 minutes after ( now 45 minutes after vaccine) started getting nerve problems behind left eye that was bothering me. Then my face got nerve problems too. Then all my teeth on top and bottom row were hurting. my lips and tongue got numb with nerve problems like I had too much Novocain. Then my throat felt like it was swelling up. I called hot Line of vaccine to report side effects. They transferred me to a Covid 19 nurse that said go to emergency room right away sounds like yiur getting Bell?s palsy. FYI my brother who lives in another state did not report his side effects. In February he got the second dose of Pfizer and he said four hours after he got nerve problems in his face and his right side of eye and mouth drooped and he was talking strange like someone with paralysis of mouth . Still has it but never went to doctor and won?t fill out info to report
59 2021-03-22 numbness DIZZINESS, NUMBNESS IN FOREHEAD, NOSE AND UPPER LIP, THE NEXT DAY A CLOT ON THE LOWER LIP
59 2021-03-22 pain in extremity Brand and lot of vaccine: EL9267 Pfizer 2nd dose, CN6200 Pfizer 1st dose given 2/26 @1400 at stadium... Read more
Brand and lot of vaccine: EL9267 Pfizer 2nd dose, CN6200 Pfizer 1st dose given 2/26 @1400 at stadium Date and time adverse event started: 3/19/2021 @1400 Did the adverse event start after the first or second vaccination? arm started getting sore in the evening, then legs feels achy, lower back pain, 99.6F, pain in armpit in injection arm left arm, itching to back then dizzy
59 2021-03-23 cold sweat, feeling cold 16 min after injection i feltmlike i needed fresh air as it felt like i couldn't get a good breath. ... Read more
16 min after injection i feltmlike i needed fresh air as it felt like i couldn't get a good breath. I asked to go outside and was told no. I moved from back to the front as i felt cold and was swearing. It was sift chsnge and the staff was huddled in a corner and i called for help.2x before taking off my mask amd callinf a thried time. By this point i felt like vomiting and nedded immediate water. The thirst was intrnse. The University of Arizona didn't have anything for me to throw-up into except a half full used large janitorial garbage can. I was given water and that really helped the thirst and nausea. The nurse came and put a monitor on my finger and immediately took me to a back area where rhe cold sweat and chills now covered my whole body and the thirst returned. Tje nurse took my vitals and i remember my heartbeat reading in the 30s and had a very low blood pressure. No one ever experienced what was happening and i asked if i was going to die. The only thing they had to lie down on was an army cot 6" off rhe ground. I wanted to lie down so badly buy it had no sheets, pillow or anything. With all the money they get from the feds they should be able to afford a gurney. I was never told the truth about what had happened to me. I was let go with a very low heart rate of 51. My normal is 68 to 78. No follow up instructions.
59 2021-03-23 cold sweat, flushing feeling flush, dizziness and cold sweat
59 2021-03-23 pain in extremity Bad stomach ache, sore left arm
59 2021-03-23 tingling, feeling jittery, numbness I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing... Read more
I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing tingling sensation on the right side of my face and tongue and top of my head. I also felt very jittery or crawling sensation like I had to much coffee. I called the guards to my car twice and was told it was my nerves. I was released even though I wasn't feeling right and felt like was drunk driving on the way home, the worst of it passed within a hour but the fuzzy feeling lingered with numb spots on my face lasted for a few days. Now I'm afraid to get my second shot due April 3rd.
59 2021-03-24 weakness, migraine, muscle spasms Upper abdominal pain (previously reported) - still sporadic; relieved by Alka Seltzer and/or food 03... Read more
Upper abdominal pain (previously reported) - still sporadic; relieved by Alka Seltzer and/or food 03/20 0200 - severe chills with muscle spasms leading to painful tonic spasms; treated with Disatat 10 mg x 2 03/20 -continuing - fever (<100) treated with acetamenophen/ibuprophen PRN; 03/35 - fever 102 treated with acetamenophen 03/20 continuing - joint pain; increased weakness in L shoulder 03/20 continuing - malaise/fatigue 03/20 0900 - migraine relieved by Relpax
59 2021-03-24 burning sensation Itching and rash NOT at injection site: head, neck, arms, chest, stomach, legs Rash is fairly fine,... Read more
Itching and rash NOT at injection site: head, neck, arms, chest, stomach, legs Rash is fairly fine, NOT hives. Pops up on various parts of body, itchy and mild burning. This is NOT a terrible side effect, but I thought it best to report. It is not yet getting better or subsiding (got injection 5 days ago).
59 2021-03-24 feeling of body temperature change Date and time adverse event started: 3/22/2021 less than 12 hours after 1st dose Adverse events expe... Read more
Date and time adverse event started: 3/22/2021 less than 12 hours after 1st dose Adverse events experienced and are they still occurring now: started with headache and muscle pain less than 12 hours of receiving first dose. On 3/23/21 experiencing body ache, joint pain, hot/cold feeling, upset stomach (no diarrhea). Feeling much better, symptoms resolved except for fatigue.
59 2021-03-24 flushing 10 minutes after shot had Pain in neck Then headache Then flushing (wave of heat from head down arm... Read more
10 minutes after shot had Pain in neck Then headache Then flushing (wave of heat from head down arms and hands. Skin mottled and red) Then Blood pressure observed to be was high Then hives and itching developed Then Dizziness occurred Then nurses took me from shot clinic to the ER All above symptoms within 30 minutes of shot About 9 pm experienced swollen and painful veins in left arm (shot was in right arm) as of 7pm next day still painful veins in left arm.
59 2021-03-24 muscle spasms I started having several symptoms of COVID-19. I had fever (went up to 102.8), chills, high pulse, ... Read more
I started having several symptoms of COVID-19. I had fever (went up to 102.8), chills, high pulse, diarrhea and cramping, and slight headache for about 3 or 4 days. Then, I was having sharp, severe shooting pains in my ring finger and elbow. I talked to my primary care doctor's office 3 times. I went to the emergency room on Thursday, March 18th. The hosptial did a CT scan of my chest and abdominal area, a urine test, some blood work, etc. I also had a COVID-19 test on both March 18th and March 21st. They were both negative.
59 2021-03-24 pain in extremity First dose 2/28 - was fine Second dose 3/21- that evening headache dizziness took ibuprofen around ... Read more
First dose 2/28 - was fine Second dose 3/21- that evening headache dizziness took ibuprofen around 8-9pm. 3/22 - soreness in arm, headache. 3/23 - swelling on shot area leading around to underarm, hard lump side of underarm area very sore. Took ibuprofen Add ice.pack
59 2021-03-24 pain in extremity Pain in the arm Body aches Headache Chills
59 2021-03-24 pain in extremity Arm pain Left chest pain Difficulty breathing
59 2021-03-24 pain in extremity Arm pain for two days, body temperature of 99.7 f Third day: tiredness , chills , 98.5 f, stomach p... Read more
Arm pain for two days, body temperature of 99.7 f Third day: tiredness , chills , 98.5 f, stomach pain Fourth day: tiredness , chills, stomach cramps. Fifth day. Tiredness, stomach pain, chills Sixth day:headache, ear pain, sneezing, sore throat, tachycardia. Seventh day: Headache, ear pain, sneezing, sore throat , tachycardia. Eighth day: Headache, ear pain, sore throat, sneezing, tachycardia. Anxiety. Ninth day: Headache, ear pain , sore throat . Anxiety and bad mood. I take ibuprofen 600mg every day , my vitamins , lots of fluids.
59 2021-03-24 slow speech, depressed level of consciousness, pain in extremity, hot flush, tremor ?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, ... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, possible seizure, tinnitis, pressure in frontal cortex, brain fog, inability to urinate for 1 day, headache, exhaustion-constant sleeping, rapid heart rate, problems speaking-slow and deliberate, dehydration, motor skills slower, sinus's and whole brain feels dry, time going by really fast, ears hurt, teeth hurt, right and left neck hurt, left arm hurt, right shoulder hurt, hot flashes day and night. MEMORY ISSUES SUBSIDED TODAY, still brain fog, still RAPID HEARTBEAT and shaky. If all of this brain fog/rapid heartbeat doesn't subside by Monday March 29, 2021, an EEG will be ordered to look at the brain. I'm on my 2nd weeks bedrest with no exercise and Tylenol every 6 hours, the tylenol every 6 hours seems to help with some of the brain fog and the rapid heart beat, if I forget to take it I am soon reminded as my heart races and the brain fog reappears.
59 2021-03-25 numbness 1100: patient with c/o numbness and tingling of right side of tongue. Physician on duty ordered 25m... Read more
1100: patient with c/o numbness and tingling of right side of tongue. Physician on duty ordered 25mg Po Benadryl to be given. Patient took Benadryl and refused water. 1110: Patient checked on by EMS on Duty with no changes. 1120: No changes to mouth noted still for patient. 1130: Still no changes, EMS on duty cleared patient for discharge home after 30 minutes of observation. Informed patient to seek immediate medical attention if symptoms should worsen. Patient communicated understanding.
59 2021-03-25 tingling Patient had tingling sensation that started on her body immediately after injection. Her face became... Read more
Patient had tingling sensation that started on her body immediately after injection. Her face became red and she was moved into the EMS room for observation. The MD on call ordered zyrtec 10mg by mouth to be given x1 now and patient tolerated well at 1545. Apple juice was supplied to the patient at 1550. 1600 patient reported tingling sensation had decreased, denied any shortness of breath, chest pain or nausea. 1605 patient was discharged from clinic in no distress.
59 2021-03-26 flushing, pain in extremity On day of vaccine I became a little flush 30 minutes after vaccination. Next day, arm hurt. Otherwis... Read more
On day of vaccine I became a little flush 30 minutes after vaccination. Next day, arm hurt. Otherwise I felt fine. 5 days after receiving the vaccination I noticed I was dizzy when standing up in the AM. Late AM I developed a headache which got more severe in the afternoon through the evening and was accompanied by nausea, chills, briefly high heart rate (199), fatigue, and the dizziness. Took 2 Tylenol in the evening . 2 hrs later symptoms improved dramatically. Felt a little unsteady today.
59 2021-03-26 numbness, migraine 3/25/21 6:00 pm chills, shivering, muscle aches, numbness in left arm hand and left leg. 8:00 pm mi... Read more
3/25/21 6:00 pm chills, shivering, muscle aches, numbness in left arm hand and left leg. 8:00 pm migraine headache, nausea & vertigo.
59 2021-03-26 tremor, weakness Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Dif... Read more
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Eye ball rotating
59 2021-03-27 bell's palsy Developed Bells Palsy
59 2021-03-27 pain in extremity The next morning, my arm was quite sore. I had a mild headache and was fatigued. As the day progress... Read more
The next morning, my arm was quite sore. I had a mild headache and was fatigued. As the day progressed, my headache and fatigue worsened. I had stabbing pains in the middle of my back and my front chest area. I rested in bed or slept most of the day. In the evening I started to get a fever, which peaked at 101° around 2am or so. The headache was very intense, and the back/chest pains continued. I took 1/2 Vicodin® around 10pm. That was having no effect, so I took another 1/2 around 11pm. Still no effect, so i took another 1/2 around 1am, which finally eased the pain. I woke up around 4am with a somewhat milder headache, and stayed in bed until around 10am (Sunday, 3/28). Then I got up, had some breakfast, and all the symptoms were gone.
59 2021-03-27 pain in extremity Received the shot around 4pm started to have extreme discomfort in my left wrist, hand area Woke up ... Read more
Received the shot around 4pm started to have extreme discomfort in my left wrist, hand area Woke up this morning unable to move the hand without extreme pain. I have been taken 400mg of Advil every 4 hours and the pain has lessened somewhat.
59 2021-03-27 tingling SWOLLEN TONGUE AND THROAT, HIGH BLOOD PRESSURE, FAST HEART RATE, TINGLING IN FACE
59 2021-03-27 tremor uncontrollable body shakes for 4 hours from midnight to 4 am; muscle aches, fuzzy head, low grade fe... Read more
uncontrollable body shakes for 4 hours from midnight to 4 am; muscle aches, fuzzy head, low grade fever, extreme fatigue
59 2021-03-28 weakness Covid exposure on 3/3/2021. 3/9/2021 received first Pfizer vac. Within an hour was nauseated wit... Read more
Covid exposure on 3/3/2021. 3/9/2021 received first Pfizer vac. Within an hour was nauseated with pressure pain across the top of her stomach "under her ribs" and nausea. 3/10/2021 dev fever, weakness, and cough. Covid test 3/12/2021 neg. Eval in walk in clinic. Diag allergies. Rx oral steroid and Amoxicillin. A couple of days later, symptoms still continued. Eval in her physician's office 3/18/2021. Given steroid injection and antibiotic changed to Azithromycin. 3/19/2021 felt worse with pain/pressure under ribs and upper abd. eval in ER. O2 sat 87 improved to 93 with oxygen. Labs, chest xray, and CT scan obtained. Covid test neg. Admitted to hosp with diag of bilat pneumonia. Discharged on 3/22/2921 with steroids to take over next 5 days. She continues to have mild cough and pressure under her lower ribs. F/u appt scheduled with her physician. Was advised by her physician her pneumonia might be a reaction to the vaccine.
59 2021-03-28 flushing Released from observation at 10:20am. Walking towards exit my throat felt strange. Employee asked ho... Read more
Released from observation at 10:20am. Walking towards exit my throat felt strange. Employee asked how was my day and I said great but my throat feels funny. Employee immediately escorted me to front of facility and asked me to wait to see how I was feeling however moments later paramedic walked up to me and escorted me to screened medical area. My face and neck were flushed, throat and swallowing were changing. Paramedic gave me Benadryl and antacid tablet with water however Pharmascist arrived at same time and instructed paramedic to administer Benadryl shot as well. BP elevation, itch.
59 2021-03-28 numbness, feeling hot Heat through body, Nausea, numbness in left hand, pressure in head, cognitive problems, pressure in ... Read more
Heat through body, Nausea, numbness in left hand, pressure in head, cognitive problems, pressure in head, memory problems, joint pain, right eye not focusing Have seen my primary, rheumatologist- received injection of steroid and put on oral steroids, chiropractor nerve stimulation, adjustment. Waiting to see a neurologist
59 2021-03-28 pain in extremity After going to sleep on my legs started hurting really bad and better next morning.
59 2021-03-28 pain in extremity Fever, chills, arm soreness, nausea, headache, eyes hurt, back pain, dizziness, feel bad
59 2021-03-28 cold extremities Dry eyes at 3 AM, feeling run down at 10:30 AM, Injection site really sore, stiff neck, headache, ey... Read more
Dry eyes at 3 AM, feeling run down at 10:30 AM, Injection site really sore, stiff neck, headache, eyeballs feel tender and sore, ice cold feet that will not warm up, Skin on torso tender, nose stuffed up, loss of appetite at 1 PM. Try to nap but cold feet can?t wake me up. Took my temperature at 7:45 PM 100.6, Took a Tylenol and back in bed.
59 2021-03-28 seizure Pt called stating on 3-26-21. She woke up with 102 fever. Had been taking Tylenol since received vac... Read more
Pt called stating on 3-26-21. She woke up with 102 fever. Had been taking Tylenol since received vaccine Twice that night and continued the next day. Later that day puts husband who is an md said she experienced a seizure for about 10 seconds and wanted to report the adverse effect to someone. The patient did not go to er or md office. Did not call her regular md. She stated she was fine and had no other ill effects
59 2021-03-29 weakness Ringing in ears, headache behind eyes, weak.
59 2021-03-29 cold sweat 3:42 pm pt complained she was dizzy, nauseated, and was hyperventilating. Pt also complained of pain... Read more
3:42 pm pt complained she was dizzy, nauseated, and was hyperventilating. Pt also complained of pain in her sternal area. vital signs taken BP 160/110 she was very clammy. PA called over to evaluate. Coached pt to slow down her breathing while we were applying a cool rag to her forehead and fanning the patient. Pt started doing better when she slowed her breathing, she said she had HTN but no history of MI. About 2 minutes later she started vomiting and her chest was still hurting. Doctor called over to evaluate patient chart checked for her allergies and Decadron 10 mg and Benedryl 50 mg IM ordered and given in right deltoid. Within a few minutes the patient was regaining her color and breathing much better. She was able to call her family member to have them pick her up instead of her driving home. 5 minutes later pt complained she was having worse sternal pain and was having trouble swallowing. Doctor ordered Epinephrine 1 mg which he administered in her left thigh, and to call 911 so they can bring her to the ER for further evaluation. Pt was transported by wheelchair to the procedure room with Doctor and CMA. EMS arrived, CMA gave report to EMS, transported to Hospital.
59 2021-03-29 cold sweat 4-5 hours after receiving my first dose I started feeling achy and tired. This achiness became worse... Read more
4-5 hours after receiving my first dose I started feeling achy and tired. This achiness became worse, I was experiencing cold sweats and developed a low grade fever, 99.9°F. I slept for 42 hours waking briefly to urinate and drink water. I was awake for a couple of hours last night and ate. 48 hours later I feel much better, just a few residual achy muscles.
59 2021-03-29 feeling hot, tingling, numbness immediately following my left arm got a hot sensation, my hand went numb, and my fingers tingled. 1... Read more
immediately following my left arm got a hot sensation, my hand went numb, and my fingers tingled. 1 hour later I was nauseated and I had flu like symptoms, body aches, chills and a horrific headache. By 4th hour I needed to go to bed.
59 2021-03-29 migraine Sharp headache up the middle of my head that got progressively worse as the day went on. By early ev... Read more
Sharp headache up the middle of my head that got progressively worse as the day went on. By early evening was more like a migraine, with slight nausea and aversion to lights. Extra strength Tylenol didn't really help. Also joint aches and slight chills, but no fever. Was better by the next day, but still a mild headache and some joint aches.
59 2021-03-29 tingling Wheezing, tingley in left arm, numbness sensation like novocaine on left side of jaw, heart palpitat... Read more
Wheezing, tingley in left arm, numbness sensation like novocaine on left side of jaw, heart palpitations, aching between shoulder blades, headache
59 2021-03-30 weakness 103 degree temperature, joint and muscle aches/soreness, zero energy.
59 2021-03-30 weakness Started on the 8th day. Within the first 12 hours I had a fever, chills, aches, cough, and head co... Read more
Started on the 8th day. Within the first 12 hours I had a fever, chills, aches, cough, and head congestion. As of today 3/31, tire and lack of energy. I do hav a history of sinus infections and spring allergies.
59 2021-03-30 weakness When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen;... Read more
When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen; felt unwell; weak; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as a single dose (at the age of 59-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer-BioNTech COVID-19 Vaccine first dose on Saturday, 13Mar2021, and was fine after the shot but had a reaction on Sunday, 14Mar2021. On 14Mar2021, she got up to make breakfast and started feeling real dizzy and the next thing she knew, she was on the floor; this happened twice. When she passed out, she must have hit something on her right side, since her leg and knee feel bruised and right eye was swollen. She felt unwell, dizzy and weak; no dizziness today (15Mar2021). She planned to discuss further with her physician. The outcome of the event dizziness was recovered on 15Mar2021 and unknown for the rest of the events. Information on the lot/batch number has been requested.
59 2021-03-31 weakness Within 15-minutes of vaccination, the patient reported feeling near-syncopal. EMS evaluated the pati... Read more
Within 15-minutes of vaccination, the patient reported feeling near-syncopal. EMS evaluated the patient on-site. The patient was hypotensive (93/63) and bradycardic (56bpm) with a FSBG of 91mg/dl. EKG demonstrated sinus brady, rate 50bpm, no ST elevation. EMS administered 4mg Ondansetron PO. EMS transported the patient to Hospital Emergency Department. In the ED, the patient reported they felt weak, dizzy, and briefly lost consciousness. The patient was not in any acute distress, but was hypertensive (141/78). The patient left AMA without a diagnosis after "waiting too long" and was informed of the risks of leaving the ED prior to complete evaluation.
59 2021-03-31 facial paralysis Pt received 1st Dose of Pfizer vaccine on 03/29/21. Mother reported that patient began to experience... Read more
Pt received 1st Dose of Pfizer vaccine on 03/29/21. Mother reported that patient began to experience Fever; Drooping & Swelling on right side of face on 03/30/21. Swelling is decreasing but there is still some drooping. The patient is Epileptic and is also taking Dilantin and Phenobarbital to control the seizures.
59 2021-03-31 muscle spasms Tinnitus and dizziness, muscle cramps
59 2021-03-31 pain in extremity Started getting fever about mid-day Monday after vaccine on Sunday. Fever got higher throughout day ... Read more
Started getting fever about mid-day Monday after vaccine on Sunday. Fever got higher throughout day til 11pm when it was 101.4. Went to sleep, woke Tuesday morning with no fever, but fatigued. Also arm was very sore, including armpit. Injection site was a little itchy. Took Tylenol and Benadryl, feeling pretty normal by Wednesday 3/31/21 night.
59 2021-03-31 pain in extremity 10 min after vaccination developed mild arm soreness, slight diaphoresis and 5/10 headache. Normal B... Read more
10 min after vaccination developed mild arm soreness, slight diaphoresis and 5/10 headache. Normal BP and pulse. Looked fine. No arm erythema/swelling. No hives. No respiratory symptoms. Treated with water/hydration and noted improvement.
59 2021-03-31 tingling Tingling right hand. 148/76 88 16. REFUSED transfer, feeling better.
59 2021-03-31 tremor, muscle spasms, involuntary muscle movements, weakness, pain in extremity Day 1st sore left arm improved the next day. On day 4th of the Pfizer vaccination, started the wea... Read more
Day 1st sore left arm improved the next day. On day 4th of the Pfizer vaccination, started the weakness, shaking ( tremors), Spasms, involuntary movement of left arm and left hand, These symptoms are worse in the left hand both at rest and with effort, whether I rest my hand on the table or I hold anything with my hand including my cell phone. The spasms are visible. Symptoms still persist at this time.
59 2021-04-01 weakness Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneo... Read more
Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, in the left arm on 19Mar2021 at 21:00 as a single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date to an unknown date, prior to vaccination. The patient had a nasal swab test for COVID on 18Mar2021 with a result of negative. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccines in four weeks prior to the COVID vaccine. The patient experienced body chills, fever, body aches, loss of appetite, weakness, sleepiness and fainted on 20Mar2021 at 01:00. The patient did not receive treatment for the events. The outcome of the events was recovering. Information on batch/lot number was requested.
59 2021-04-01 weakness Slight ha when woke up on 16th. Within 15 min dizzy and passed out. Heavy vomiting and no strength. ... Read more
Slight ha when woke up on 16th. Within 15 min dizzy and passed out. Heavy vomiting and no strength. Bone crushing pain, Laid on floor, partner called 1-800 suggested pepto mismol. Vommitted that. Called EMS to help Get. Me to bathroom and back laid down. No fever. Took other vs . Next thing I know I was in bed eating toast and cola. Left me still weak and trouble keeping balane. Should I get 2nd shot?
59 2021-04-01 breast pain Severe pain under right breast around into upper right back. Was hospitalized 12Mar2020 for two day... Read more
Severe pain under right breast around into upper right back. Was hospitalized 12Mar2020 for two days. Pain is still very intense; Severe pain under right breast around into upper right back. Was hospitalized 12Mar2020 for two days. Pain is still very intense.; This is a spontaneous report from a contactable other health professional (HCP). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in right arm on 11Feb2021 at 13:00 (Batch/Lot number was not reported) as single dose, then second dose via an unspecified route of administration, administered in right arm on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included Congestive heart failure (CHF), kidney stones, diabetes, penicillin allergy, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), both for unspecified indication. The patient previously took statin [nystatin] for unspecified indication. On 05Mar2021 at 04:00, the patient experienced severe pain under right breast around into upper right back. The patient was hospitalized on 12Mar2020 for two days. Pain is still very intense. The patient underwent lab tests and procedures which included nasal swab: negative on 18Mar2021. The patient had bloodwork, x-ray, MRI and EKG as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: The causal association cannot be excluded between the reported events of breast pain and back pain with BNT162B2 vaccine use due to strong temporal association. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
59 2021-04-01 numbness numbness along scapula on same side of arm where she received vaccine
59 2021-04-01 pain in extremity, tremor severe shaking; low grade fever, pain in left arm
59 2021-04-01 tingling Tingling to forehead and top of mouth 15 min after receiving vaccine. VS 128/88, HR 100, O2 Sat 100... Read more
Tingling to forehead and top of mouth 15 min after receiving vaccine. VS 128/88, HR 100, O2 Sat 100.
59 2021-04-01 tingling throat feels tight, tingling palms, elevated heartrate. Evaluated by EMS-Cleared
59 2021-04-02 burning sensation, electric shock sensation, numbness, tingling I had extreme burning in my throat and lungs. Later the next day my nerves felt like electricity wa... Read more
I had extreme burning in my throat and lungs. Later the next day my nerves felt like electricity was running thru my whole body. I was unable to sleep for 6 days. .My body temperature when down 95.3. It felt like my blood was racing thru my veins, both arms and legs where tingling and numb feeling. Then I have had veins rupture on my legs, hands and feet with bruising. These problems are still with me 3 weeks after 1st vaccine. This is awful and painful!!!!!! Hopefully I will go back to normal soon.
59 2021-04-02 pain in extremity, night sweats fatigue body ache headache chills nightsweats hands ache eyes ache
59 2021-04-02 pain in extremity Pain and swelling in lower legs (anterior compartment syndrome) which began on 3/15/21, 5 days after... Read more
Pain and swelling in lower legs (anterior compartment syndrome) which began on 3/15/21, 5 days after vaccination. Pain and swelling continue without abating after 2 weeks of rest, compression, ice, elevation. Stye in left eye - possibly due to inflammation in eyes. Treating with moist heat.
59 2021-04-02 tingling Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Error: Shoulder Joint ... Read more
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
59 2021-04-03 weakness BACK OF THROAT FELT SWOLLEN, SCRATCHY/ITCHY AFTER 30-45 MINUTES (BENADRYL 25 MG AND COLD DRINK HELPE... Read more
BACK OF THROAT FELT SWOLLEN, SCRATCHY/ITCHY AFTER 30-45 MINUTES (BENADRYL 25 MG AND COLD DRINK HELPED) AFTER 4-5 HOURS, DEVELOPED ABDOMINAL CRAMPING, NAUSEA, MUSCLE/BODY ACHES, FATIGUE, LIGHT-HEADEDNESS (TOOK ZOFRAN AND TYLENOL FOR SYMPTOMS) THROAT FELT BETTER AFTER A FEW HOURS; OTHER SYMPTOMS LASTED 3 DAYS; STILL EXPERIENCING FATIGUE/WEAKNESS ON DAY 4 BUT GENERALLY FEELING BETTER OVERALL
59 2021-04-03 breast pain Soreness in vaccine spot, chills, thirst, on the first night. Lack of appetite, pain, and dizziness ... Read more
Soreness in vaccine spot, chills, thirst, on the first night. Lack of appetite, pain, and dizziness on the second day, and soreness spreading to the left breast and side, dizziness, thirst, on the third day.
59 2021-04-03 migraine Nauseous, Migraine and loss of taste
59 2021-04-03 migraine Migraine Nausea Vomiting Diarrhea Headache Dizzy Heart palpitations In a fog Extreme fatigue Muscle ... Read more
Migraine Nausea Vomiting Diarrhea Headache Dizzy Heart palpitations In a fog Extreme fatigue Muscle & joint pain Loss of appetite Dry mouth Started 4/3/2021 @ 11:00 am Still continuing
59 2021-04-03 pain in extremity Frozen shoulder/bursitis in left shoulder joint. Extremely painful, cannot use left arm. Dr prescrib... Read more
Frozen shoulder/bursitis in left shoulder joint. Extremely painful, cannot use left arm. Dr prescribed steroid and muscle relaxant which were started on 04/03/2021. Still extremely painful on 04/04/2021
59 2021-04-03 pain in extremity Severe arm pain the first 3 days after vaccination (couldn't lift my arm). The severe pain subsided ... Read more
Severe arm pain the first 3 days after vaccination (couldn't lift my arm). The severe pain subsided by day 4 but arm pain continues to date (4/4/2021); enough to where I have to take otc ibuprofen and apply otc topical pain cream.
59 2021-04-03 pain in extremity Bad headache,acky body , left arm pain ,chills,fever,sore throat
59 2021-04-03 speech disorder eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; li... Read more
eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown. Information on the lot/batch number has been requested.
59 2021-04-04 weakness After the first vaccination I experienced a headache, and that was about it. The second vaccination ... Read more
After the first vaccination I experienced a headache, and that was about it. The second vaccination kicked my butt! I have been as ill as ever had been in my life. Severe achiness, fever (although I did not take my temperature) headache, I threw up the first night, severe weakness, sweating profusely. I have been ill since the second injection, that evening, and am JUST starting the recovery process. Would I do it again? YES! Covid-19 is a lot worse than the adverse effects I received from the vaccinations. Yet, I did not expect it to be anything near as bad as it was!!!!!
59 2021-04-04 feeling hot, tingling Patient received the second dose of the Pfizer Covid vaccine. Patient has no adverse reaction after ... Read more
Patient received the second dose of the Pfizer Covid vaccine. Patient has no adverse reaction after dose 1. Patient complained of "a hot feeling going through my body" less than 10 minutes into her observation period. Patient appeared redness on her chest, face and hands. Patient did not complain of any shortness of breath, chest pain, and was alert and oriented x4. patient was advised to check herself for any hives with the assistance of female nurse and complained of lightheadedness upon standing. patient was seated back down and reported the feeling went away. Patient remained A/Ox4 during the entire encounter. Patient denied feeling this feeling before. patient had a radial pulse of 60bpm and a BP of 110/palpation. patient was continued to be monitored as she attempted to contact her family member. patient now reported a headache which she described as "pressure". patient also reported feeling tingling in her hands. patient still had no complaints of difficulty breathing and had no angioedema. 911 was called and EMS arrived on scene. patient care was transferred to EMS.
59 2021-04-04 pain in extremity Telephone call received from client who reports she received vaccine yesterday and is now having a ... Read more
Telephone call received from client who reports she received vaccine yesterday and is now having a sore arm and pressure in her ears. Also stated she had sinus infection for a month. Having buzzing in her ears but not sure if buzzing or "shot:. Stated at work at time of this report and just wanted to report.
59 2021-04-04 tingling, hot flush Worsening of mild, intermittent tinniutus to constant high-pitched loud tinnitus. Pressure in head a... Read more
Worsening of mild, intermittent tinniutus to constant high-pitched loud tinnitus. Pressure in head and ears that comes and goes (varies from day to day), waves of pins and needles through head and face (intermittent, daily), flushes of heat through body (intermittent, most days of week). Queasiness (most of the time), reduced appetite. The tinnitus manifested as a screech that sounds like it is in the head rather than the ears, with lower frequencies that change in intensity in both ears.
59 2021-04-04 sensory loss Woke up morning after receiving vaccine injection and my tongue felt scalded, as if I had burned it ... Read more
Woke up morning after receiving vaccine injection and my tongue felt scalded, as if I had burned it drinking a too-hot beverage. My sense of taste was seriously diminished - everything I ate tasted bland. The scalded sensation lasted about 12-14 days before it began to abate. Gradually improved sense of taste after 12-14 days. Sensation nearly gone completely by about day 19 or 20.
59 2021-04-04 tremor, difficulty speaking, tingling 25 minutes Post injection: Left eye issues. Itchy, swollen behind the eye and feeling like something... Read more
25 minutes Post injection: Left eye issues. Itchy, swollen behind the eye and feeling like something was in it or irritating it. It kept driving me to check if something was in it. I put in renu eye drops and did not think any more of it. 40 minutes post injection: both feet red and swollen left foot about half of the top, the whole right foot looked like a giant hive or welted area across the whole top of foot. The injection site began being quite sore, and it also looked welted and felt hot to the touch. I kept checking my left rib cage and my left thumb as I was sure there was going to be hives, because I could not stop rubbing or scratching them as they itched so badly. I continued itching and feeling weird tingly sensations and either rubbed or scratched these areas to no avail. Even my head itched terribly by the second day. 45 minutes post injection: Tightness and scratchiness in throat appeared and my throat was sore, my voice began going out and my voice got hoarse. There was about a two inch area of my throat in which I felt I needed to keep trying to clear something that was stuck. (This made no sense to me as I was able to drink water without any issues.) I had a slight cough every time I stopped drinking, so I continually drank water while I was not trying to sleep. My chest was tight, but because I have asthma I took albuterol and thought nothing of it. (This really did not help, but I did not get worse either.) About an hour after the shot, I constantly felt on the verge of shaking, much like when you have a fever, but I did not think to check my temperature until the following morning when I was extremely tired, felt like I had a sinus headache and possibly did have a fever. My temperature was 99.4 degrees farenheight. At this point, I felt very flu-ish and achy. My armpit area hurt a lot and I chewed two aspirin. I experienced wheeziness, chest tightness, and hoarseness the second and third day as well. I had the morning congestion and stuffiness as well as the need to keep clearing my voice still as of this morning but to much less degree as the initial onset. The skin itchiness is still ongoing, but to a much lesser degree than previously had.
59 2021-04-04 tremor Systemic: Shakiness-Mild
59 2021-04-05 cold sweat High Grade Fever, Body Aches, Sleeplessness, Cold Sweats, Hot Sweats lack of any appetitie
59 2021-04-05 feeling hot Five minutes after receiving vaccine, it started with heat in my lower stomach and the heat kind of ... Read more
Five minutes after receiving vaccine, it started with heat in my lower stomach and the heat kind of moved up a little bit and I got real hot and then my noticed my heart rate increased. I knew my blood pressure was up. Normally, it's very controlled with meds. They took my blood pressure and it was high . Much higher than what I normally have. It started to subside but then I felt the heart rate increase again. And they took me to the hospital -Hospital - and by the time I got to the hospital my symptoms seemed to be gone - I felt okay. Doctor checked me and said that everything looks good. I walked out on my own. I was a little tired later on but I had no other symptoms.
59 2021-04-05 pain in extremity Sore arm, fatigued, chills and malaise 60 hours post injection
59 2021-04-05 pain in extremity Injection at 9:55 am. Itchy eyes and root of mouth started 15 minutes after injection. I waited for... Read more
Injection at 9:55 am. Itchy eyes and root of mouth started 15 minutes after injection. I waited for an additional 15 minutes at facility and the symptoms went away on their own. At 12 noon at home malaise set in. I rested off and on for the remainder of the day. At 4 pm, pain and swelling in right arm. No treatment. Also, at the same time pain in vaginal area started. Pain remained for remainder of the evening and night. The next morning the pain had lessened some, however not totally. I can not think of any cause for the vaginal pain, just that it started several hours after vaccine was administered.
59 2021-04-05 tremor Fever, shaking chills, lower back pain, headache and pain in joints; Ibuprofen; felt better in 36 ho... Read more
Fever, shaking chills, lower back pain, headache and pain in joints; Ibuprofen; felt better in 36 hours with only stiffness in fingers and full headache; completely better within 72 hours
59 2021-04-06 weakness shortly after vaccine admin, patient states felt weakness all over, feeling like needing to lie down... Read more
shortly after vaccine admin, patient states felt weakness all over, feeling like needing to lie down, light sensitivity, "gel legs". arrived to obs 1122, bp 155/83, hr 54, rr 18, sao2 97% on ra. continued to c/o lightheadedness lying, sitting and standing, ortho bp/hr 167/82 52 lying, 163/76 54 sitting, 154/82 54 standing. states has low hr, n propanolol. 1230p ems called due to unrelieved dizziness/lightheadedness for transport to hospital, report provided to ems.
59 2021-04-06 weakness O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the low... Read more
O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the lower lungs that was rubbing on her diaphragm; Pneumonia; Cough/bad cough/dry cough; Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage; gastroenteritis; short of breath; she wasn't breathing deep; feels like she doesn't have any energy; feeling bad; nauseated/felt sick to stomach; ate about half of her breakfast, this lasted for several days, she wouldn't eat much; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer. This consumer reported similar event for two patients. This is the first of two reports. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206, expiry date: unknown), via an unspecified route of administration, on 09Mar2021, as single dose, for COVID-19 immunisation. Medical history included exposure to SARS-COV-2 on 02Mar2021 (reported as "daughter tested positive for COVID on 02Mar2021, patient had been around their daughter and their daughter's husband, they went out to eat with them on the night of 02Mar2021"). Concomitant medication included esomeprazole sodium (NEXIUM) taken for an unspecified indication, start and stop date were not reported. On 09Mar2021, the patient received her first shot. About 20 minutes after she took the shot, she started feeling bad and became nauseated/felt sick to stomach. On 09Mar2021, the top part of her stomach would hurt, and she started developing a cough. On 11Mar2021, the patient felt like she doesn't have any energy. The coughing went pretty bad so on 12Mar2021, the patient took a COVID-19 PCR test and it came back negative. The patient kept having a bad cough so then they went to the doctor where they put the patient on prednisone 20 mg and amoxicillin 875 mg on 12Mar2021. On 16Mar2021, the patient went to the family doctor and the doctor put the patient on azithromycin and gave her a steroid shot. Then the patient kept coughing and her stomach was hurting right at the bottom of her rib cage. The patient was never getting better or anything. So, on 18Mar2021, the patient had COVID-19 Virus test where they swabbed her nose and the test came back negative. The patient was taken to the hospital on 19Mar2021 at 11:30 where they did an x-ray of the patient's lungs and her O2 level was 82-86 sitting in the bed (also reported as 84-86 so she was put on oxygen), performed CT scan of her lungs and it looked like there was inflammation in the lower lungs that was rubbing on her diaphragm, and performed Chest CT which determined pneumonia. That night they did another COVID-19 virus test where they went really deep and it came back negative. The patient was admitted to the hospital on the night of 19Mar2021. The patient was given IV ceftriaxone, IV azithromycin, azithromycin (also reported as Zythromax), one breathing treatment, and they said they may have to send the patient home with some oxygen. It was also reported that on 19Mar2021, the patient did really good with coughing, she didn't cough that much. The patient had a dry cough that wasn't productive at all. The patient acted kind of short of breath because she wasn't breathing deep because of the pain in the top part of her stomach, but the reporter doesn't believe it was true shortness of breath. When the patient got out of the hospital on 22Mar2021, she didn't need to come home with the oxygen. The patient's oxygen level is running pretty good at the time of the report, in the lower 90s (Mar2021). The patient was on Decadron 6 mg for 5 days and she's doing pretty good, she still has a little bit of a cough. It was also reported that in Mar2021, the patient only ate about half of her breakfast, this lasted for several days, she wouldn't eat much. The patient pretty much recovered from the nausea. When she ate, it felt like everything would make it to her stomach and just sit there. The emergency room doctor said it could be from gastroenteritis, also they gave the patient several rounds of Protonix. The patient usually takes Nexium every night. The doctor felt that this event could very well be from the vaccine. The reporter asked if the patient could get the second shot on 30Mar2021. The patient was recovering from "Cough/bad cough/dry cough", "Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage", and "O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen"; has recovered from "nauseated/felt sick to stomach" on an unspecified date. The outcome of the events "inflammation in the lower lungs that was rubbing on her diaphragm", pneumonia, "feeling bad", "ate about half of her breakfast, this lasted for several days, she wouldn't eat much", "feels like she doesn't have any energy", "gastroenteritis", "short of breath" and "she wasn't breathing deep" was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329963 Same reporter, drug and event; different patient
59 2021-04-06 bell's palsy Patient reported no significant issues after 1st dose of pfizer vaccine or any immediate issues afte... Read more
Patient reported no significant issues after 1st dose of pfizer vaccine or any immediate issues after 2nd dose. Approximately 3 weeks after 2nd dose, patient presented to her PCP and she reports that her PCP said she had Bell's Palsy. The PCP isn't apart of our health system so we don't have any more details than that. She reached out to one of our case managers here to report the incident and that information was passed on to the pharmacy for reporting.
59 2021-04-06 hot flush On Day 5 after receiving the second dose of the Pfizer vaccine, I woke up with hot flashes. I have f... Read more
On Day 5 after receiving the second dose of the Pfizer vaccine, I woke up with hot flashes. I have felt flu-like body aches and a fairly intense headache. 6 hours later I am feeling better but still a little nauseated and "pale" feeling.
59 2021-04-06 numbness, bell's palsy, involuntary muscle movements Bell's Palsy on left side of face: eyebrow, eye lid, nostril, cheek, and mouth droop; can not blink ... Read more
Bell's Palsy on left side of face: eyebrow, eye lid, nostril, cheek, and mouth droop; can not blink eyelid; eye and mouth do not close all the way; numbness in mouth, tongue, cheek, and forehead; pain behind left ear; dry eye, and mouth; and fatigue. It all started when I awoke on Wednesday, March 17, 2021 at 9:27 am.
59 2021-04-06 numbness head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then fe... Read more
head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb, numbness to both hands; started feeling sweaty; shortness of breath; light headed; nausea; blood pressure drop to 40; The initial was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 05Jan2021 (Batch/Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included atrial fibrillation, thyroid problem, hearing problem from an unknown date and unknown if ongoing, Stroke like paralysis from 2014 to an unknown date, gallbladder removal in 2018. Concomitant medications included sotalol, taken for atrial fibrillation from Dec2019 and ongoing; levothyroxine taken for thyroid disorder from 2017 and ongoing; cyanocobalamin (B-12) taken for an unspecified indication from 2014 and ongoing; aspirin [acetylsalicylic acid], taken for an unspecified indication from 2014 and ongoing. The patient experienced 3-5 minutes after the first dose on 05Jan2021, started feeling sweaty, shortness of breath, light headed, nausea, numbness to both hands. Next day 06Jan2021, wake up with numbness to left hands, head aches, chills, weird feeling in head (back left side of head). This went on for about 2 weeks lasted 1 month got better as days went day. It was also reported that she experienced that her left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb for period of 2 weeks. Her blood pressure drop to 40 on 05Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop to 40 on 05Jan2021, sars-cov-2 antibody test: 0 (came out 0 antibodies on my blood work had never been expose to anyone with Covid 19) on 24Nov2019, sars-cov-2 test: negative on 08Jan2021. The patient also reported that on 05Jan2021, she received the dose and had a reaction to it, but that same day her mother was taken to the hospital because she wasn't breathing well and she came out positive to Covid, she passed away 14 days after the patient took a test on Covid 08Jan2021 tested negative. She don't know if it was soon to be tested but other family member tested positive. The patient did not receive treatment for the events and was hospitalized due to the events. The patient did not recover from nausea, headache, chills while the outcome of the other events was unknown.
59 2021-04-06 numbness Numbness in my left hand last 3 fingers
59 2021-04-06 pain in extremity Strong joint pain in both hips and left knee. Very strong muscle pain in the front of both thighs. ... Read more
Strong joint pain in both hips and left knee. Very strong muscle pain in the front of both thighs. (began about 4 hours after injection) Took one (1) acetaminophen 500 mg caplet. Took one (1) Calcium Magnesium Zinc D3 supplement with food three (3) times. Took naps. Pain lasted throughout the night. Subsided by the next morning.
59 2021-04-06 pain in extremity Extremely sore arm. Tuesday 3:00AM woke up with diarrhea, chills then sweats feeling like I was goin... Read more
Extremely sore arm. Tuesday 3:00AM woke up with diarrhea, chills then sweats feeling like I was going to throw up. Slept the whole next day and night, couldn't keep my eyes open.
59 2021-04-06 pain in extremity Left arm became sore around 8pm on 4/5/21. On the morning of 4/6/21, left arm was sore and I had so... Read more
Left arm became sore around 8pm on 4/5/21. On the morning of 4/6/21, left arm was sore and I had some body aches and chills. By 12:30 pm on 4/7/21, left arm still a little sore but body aches and chills are gone
59 2021-04-06 tingling, numbness 30 min out my pointer finger and thumb became numb. It then moved to the left side of my face (corn... Read more
30 min out my pointer finger and thumb became numb. It then moved to the left side of my face (corner of left eye around my cheek bone into the bridge of nose), and the left side of my tongue. It was a tingly sensation (similar to your face/lip waking up after being given Novocaine). It remained all evening on 4/5 and has continued to be intermittent in my cheek.
59 2021-04-06 tingling At 10:00, my left arm ( arm shot) started being asleep. very mildly.
59 2021-04-07 weakness Feeling unusually tired, weak, achy, headaches
59 2021-04-07 feeling jittery First symptom noticed was a very high heart beat rate. I assumed it was a reaction to the sucrose, ... Read more
First symptom noticed was a very high heart beat rate. I assumed it was a reaction to the sucrose, which appeared as an ingredient in the literature about the vaccine that the pharmacy provided. However, this symptom persisted for 4 days, the rate slowing somewhat on the 4th day. It was so uncomfortable it prevented getting sleep. I made a point of staying well hydrated before and for 4 days after the injection. Other symptoms included jumpy, jittery muscles, feeling I had 4 or 5 rods extending from my shoulders to my brain, a very localized but intense pain in my left shoulder, general muscle ache and stiffness , and an overall feeling of being unwell.
59 2021-04-07 throat numbness 30 min after, bad taste in mouth.; throat felt odd; couldnt swallow; roof of mouth, back of throat a... Read more
30 min after, bad taste in mouth.; throat felt odd; couldnt swallow; roof of mouth, back of throat and back of tongue was numb like had novacaine.; roof of mouth, back of throat and back of tongue was numb like had novacaine.; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 09:30 (Batch/Lot Number: EL9269) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes, High Blood Pressure, High Cholesterol, known allergies, covid-19 prior vaccination. Concomitant medication included dulaglutide (TRULICITY); insulin lispro (HUMALOG); insulin detemir (LEVEMIR); canagliflozin, metformin hydrochloride (INVOKAMET); eicosapentaenoic acid ethyl ester (VASCEPA) all for unspecified indication. It was reported that on 12Feb2021, 10:15 AM 30 min after vaccination, bad taste in mouth. Then throat felt odd, couldnt swallow, had to really concentrate to swallow, roof of mouth, back of throat and back of tongue was numb like had novacaine. Outcome of the events was recovered on unspecified date in 2021.
59 2021-04-08 facial paralysis Pt. received her 2nd dose of the vaccine and while waiting in the pod she complained the left side ... Read more
Pt. received her 2nd dose of the vaccine and while waiting in the pod she complained the left side of her tongue was tingling. She was given some water to sip. Then stated that she felt her left cheek droop and her left eye is not focusing as well as before. Stated she did not have a reaction after her first dose. A droop was not noted on her face. Pt. initially refused (thought it would take too long) but then agreed to be taken to the E.D. and ambulated instead of using a w/c. Upon arrival, she stated that her tingling seemed to have worsened and it was now on her buttocks, she reported to an RN who came to triage her.
59 2021-04-08 feeling hot On Day 7 (April 1) I noticed red welts and hives randomly all over my body. They are very itchy. ... Read more
On Day 7 (April 1) I noticed red welts and hives randomly all over my body. They are very itchy. More pronounced after a shower or when I wash my hands. Benadryl helps only a little. On Day 15 (April 8) in addition I felt warmth and bloating of the ankles - more so on the left leg.
59 2021-04-08 muscle spasms 1st, cramping legs, 2nd- nausea-3rd-very tired- 4th sm headache-5th sore body,- 6th next day (4-8-2... Read more
1st, cramping legs, 2nd- nausea-3rd-very tired- 4th sm headache-5th sore body,- 6th next day (4-8-21) right armpit lymph node hurts- swollen
59 2021-04-08 pain in extremity Muscle Aches, Joint Pain, Sore Throat, Ears Hurt, Temperature/fever, left side of head has constant ... Read more
Muscle Aches, Joint Pain, Sore Throat, Ears Hurt, Temperature/fever, left side of head has constant sharp pain, the rest of my head feels like a sinus headache, congestion in my head and nose, chest hurts. Went to ER. They gave me fluid IV and Tylenol. My body and joint pain felt better for about 4 or 5 hours, but now it?s bad again. Nothing else improved. It has been 39 hours now
59 2021-04-08 pain in extremity very sore arm, fatigue
59 2021-04-08 pain in extremity Left arm became extremely sore within an hour. Next day severe bone and muscle pain in arms and leg... Read more
Left arm became extremely sore within an hour. Next day severe bone and muscle pain in arms and legs. Chills, sore throat. Previous had covid 19 in 10/2020.
59 2021-04-09 tingling, numbness Numbness and tingling of left hand 10 minutes after vaccination
59 2021-04-10 bell's palsy nerve problems behind left eye; nerve problems in face; lips had nerve problems; tongue was numb; th... Read more
nerve problems behind left eye; nerve problems in face; lips had nerve problems; tongue was numb; throat felt swollen; Bell's palsy; lightheaded and dizzy; This is a spontaneous report received from a contactable consumer (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration in the left arm, on 11Mar2021 15:30, as single dose, for covid-19 immunisation. Medical history included known allergies to antihistamine (unspecified) and sulfur drugs. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior the vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); omeprazole; and anastrozole, all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) received at age 59 years, via an unspecified route of administration in the left arm, on 18Feb2021 15:45, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 11Mar2021 at 15:45, 15 minutes after the second dose, the patient got lightheaded and dizzy. On the same day at 16:15, 45 minutes after the second dose, the patient experienced nerve problems behind left eye, then nerve problems in face, then lips had nerve problems, then tongue was numb, and throat felt swollen. The patient reported the side effects on the hotline, and she was transferred to a nurse who told her to go to the emergency room immediately as she could be getting Bell's palsy from the vaccine. The events resulted to emergency room visit and hospitalization (unspecified date in Mar2021). Treatment for the events included unspecified IV. The patient was hooked up to an EKG and her blood was drawn for checking in Mar2021 (results were unknown). The patient was recovering from the events. Follow-up attempts are completed. No further information is expected.
59 2021-04-11 weakness, muscle spasms Severe muscle pain, spasms in my muscles. Chills, weakness. Extreme fatigue not able to do my daily ... Read more
Severe muscle pain, spasms in my muscles. Chills, weakness. Extreme fatigue not able to do my daily functions.
59 2021-04-11 weakness Patient was previously healthy and got her second injection in the right arm on 1/25/2021. She had ... Read more
Patient was previously healthy and got her second injection in the right arm on 1/25/2021. She had severe weakness of the right arm starting the day after the immunization, headaches across the whole head, severe fatigue, confusion (brain fog), worsening depression, body aches, and these all progressed and got worse for at least 14 days. She was unable to work any of those days due to weakness, confusion, and body aches. She saw me in the clinic on March 2 as she was still feeling weak, tired, confused. The clinic notes that day record: "On the next day, the 26th, she had severe pain and couldn't do much. Then she got super depressed and could not get out of bed for 2 weeks, had a lot of fatigue, body aches, and felt down. She tried going to the store one day and by the time she got done she could not get into her truck because she was in so much pain. That would have been about 2 weeks ago. She went back to work last week and was at work the whole week. She was told she does have leave time and that it did not cover the absence of work. She now needs new leave time forms completed. Currently she is in a lot of pain. She has her endocrine appointment on March 15th. The pain is getting worse. The cold is really hard on her. She is barely able to move her right arm at the end of the day, and that is the arm where she had the COVID shot. She is having a lot more weakness. She can not even take one flight of stairs now because everything hurts her. This is a huge difference than before. She used to be able to do several flights, and she can't do that anymore. She has also had vision changes. She has floaters but she is having a harder time focusing. She feels like no one would believe her, but she feels like this is all part of the reaction to COVID. She has a hard time focusing. She feels like she is going insane."
59 2021-04-11 cold sweat Feeling nauseous and clammy, extreme fatigue, pain in right kidney area
59 2021-04-12 flushing PATIENT STATES FACE FEELS TIGHT AND FLUSHED. ALSO STATED THROAT FEELS TINGLY. AFTER 5 MINTUES ALMOS... Read more
PATIENT STATES FACE FEELS TIGHT AND FLUSHED. ALSO STATED THROAT FEELS TINGLY. AFTER 5 MINTUES ALMOST ALL SYMPTOMS ARE GONE. BP 156/82 SAT 97%
59 2021-04-12 pain in extremity First shot (Feb 6) was very high on left arm. I waited 15 minutes at sight, but no adverse reaction.... Read more
First shot (Feb 6) was very high on left arm. I waited 15 minutes at sight, but no adverse reaction. The next day, arm was in severe pain. Not at injection sight, from shoulder to elbow. It subsided after one day. (it didn?t go away, just not as painful, but uncomfortable at night while sleeping) Received second shot (Feb 26) not quite as high on the same left arm. Arm still hurt when moved certain ways during the day-night was still uncomfortable. As time has passed, it has gotten more sore during the day, pangs during the day in the shoulder, upper arm, elbow, arm and wrist. At night, the pain has been unbearable, waking me up every night with pain in shoulder, arm, elbow and arm. I have used menthol patches, and taken Aleve to relieve the pain, but still every night I wake up due to pain. Went to doctor yesterday, he said the pain is in my tendon and gave me anti inflammatory Dicflofenac. I have a follow up appt in 3 weeks- if no improvement, we will start physical therapy. I took my first Dicflofenac last night before bed. I was in more pain then ever!!!!
59 2021-04-12 pain in extremity Extreme body/joint aches and very sore arm. Lasted about 18 hours. Ibuprophen helped, but could not ... Read more
Extreme body/joint aches and very sore arm. Lasted about 18 hours. Ibuprophen helped, but could not sleep with the pain. Acetaminophen did not help.
59 2021-04-12 tingling, hypersensitivity of all senses Approx 3 days after receiving the 1st dosage, experienced severe tingling in torso area. On the 4th ... Read more
Approx 3 days after receiving the 1st dosage, experienced severe tingling in torso area. On the 4th day, a small rash, very sensitive appeared, by the 6th day rash continued to get worse and extremely painful. Went to see PCP Dr, diagnosed with Shingles. Too concidential that this virus shows up 4 days after receving the Covid 19 shot. There has to be some relationship.
59 2021-04-12 tenderness Swollen and tender lymph nodes in left armpit
59 2021-04-13 difficulty speaking, numbness Patient reports funny taste in mouth, cough, lightheaded, facial numbness, hoarseness, and states "f... Read more
Patient reports funny taste in mouth, cough, lightheaded, facial numbness, hoarseness, and states "feels like cardboard in throat" Epi pen and Benadryl given
59 2021-04-13 numbness, pain in extremity Fever 101º/ Extreme Chills (3 days) Stomach ache (5 days) Strange/adverse sense of smell (3 days) S... Read more
Fever 101º/ Extreme Chills (3 days) Stomach ache (5 days) Strange/adverse sense of smell (3 days) Strange/adverse sense of taste (3 days) EXTREME lethargy /sleepiness (10 days) Aggravation of arthritis in left knee (could not walk normally for 8 day, but the condition still persists and now includes swelling) Loss of use of left arm - no range of motion, pain, etc. (ONGOING) Numbness of left leg in various stages (ONGOING) Complete numbness of left leg with sudden loss of use of left leg, resulting in a fall (March 27, 2021) Shoulder swelling in muscle at the front of left shoulder, resulting in pain with use of arm (ONGOING).
59 2021-04-13 numbness Left thigh numbness, patient said relieved with chiropractor adjustment. I suggested rule out blood ... Read more
Left thigh numbness, patient said relieved with chiropractor adjustment. I suggested rule out blood clot.
59 2021-04-13 myelitis transverse Longitudinally extensive transverse myelitis, diagnosed less than a week after vaccine administratio... Read more
Longitudinally extensive transverse myelitis, diagnosed less than a week after vaccine administration.
59 2021-04-13 pain in extremity, nerve pain -Fatigue x 3 days -Nerve pain in feet bilaterally, onset 2 days post shot, involve entire foot -Sym... Read more
-Fatigue x 3 days -Nerve pain in feet bilaterally, onset 2 days post shot, involve entire foot -Symptoms persist 3 weeks post shot-no improvement
59 2021-04-13 pain in extremity sore right arm, fever, fatigue, nausea lasted 4 days, unable to get out of bed or eat due to nausea,... Read more
sore right arm, fever, fatigue, nausea lasted 4 days, unable to get out of bed or eat due to nausea, which led to dehydration.
59 2021-04-13 tingling *Tingling left side of face, and lips and tongue 2 pm on 4/12 to present Extreme fatigue, dizziness,... Read more
*Tingling left side of face, and lips and tongue 2 pm on 4/12 to present Extreme fatigue, dizziness, buzzing of head, tinnitus, increase in head ache, stomach pain, 4/13/21 starting at 11 am and worsening throughout the day
59 2021-04-13 cold extremities Approximately, one week after my 2nd dose started to experience dizziness and feeling faint on and o... Read more
Approximately, one week after my 2nd dose started to experience dizziness and feeling faint on and off. (started this past Sunday, today is Weds). Also general feeling of 'wigginess' making it tough to concentrate. Also minor feeling of 'chills' on and off throughout my body. Also VERY cold hands (not on and off but constant). None of this has abated yet -- as of today, Wednesday.
59 2021-04-13 seizure The E.M.T's said my wife was having a "mini stroke" but cat scan was negative so it must have been a... Read more
The E.M.T's said my wife was having a "mini stroke" but cat scan was negative so it must have been a seizure. My wife is now home recovering. She is still experiencing headaches and is lethargic
59 2021-04-13 tenderness Headaches started slowly along with dizziness feelings of floating or being on a drug and then got ... Read more
Headaches started slowly along with dizziness feelings of floating or being on a drug and then got more intense after second shot and continued after for weeks until I was told I may have Giant cell Aritise. I had biopsy and was put on high does steroids. That was negative. I still get headaches and have headaches sensitive to the touch.
59 2021-04-14 breast pain Shingles back, shoulder, breast pain, painful blisters
59 2021-04-15 weakness, tingling Injection site pain Fever Chills Tiredness/weakness Body aches muscle/joint pain Nausea Feeling unw... Read more
Injection site pain Fever Chills Tiredness/weakness Body aches muscle/joint pain Nausea Feeling unwell Headache Tingling fingertips
59 2021-04-15 bell's palsy Patient experienced possible Bell's Palsy.
59 2021-04-15 flushing Pt c/o facial flushing and chest tightness 35 minutes after first dose of Pfizer. Brought to assessm... Read more
Pt c/o facial flushing and chest tightness 35 minutes after first dose of Pfizer. Brought to assessment area- vital signs assessed, lungs sounds auscultated, provided 50mg capsule PO diphenhydramine. Called Emergency Responders. Pt transported to ER for evaluation
59 2021-04-15 pain in extremity, tingling symptoms pain in left arm continue April 6, 2021 every day went to see doctor on April 14, 2021 was ... Read more
symptoms pain in left arm continue April 6, 2021 every day went to see doctor on April 14, 2021 was prescribe a inflammation and muscle relaxer. Left arm continue to hurt the next day with finger tips on left hand begin to tingle, I call my doctor he sent me to have a ultra sound of my left arm and do blood work. upper extremity duplex ultrasound
59 2021-04-15 pain in extremity fever, chills, lower leg pain, similar to shin splints, in both legs. Leg pain lasted about 8 hours.... Read more
fever, chills, lower leg pain, similar to shin splints, in both legs. Leg pain lasted about 8 hours. Others lasted about 36 hours
59 2021-04-15 pain in extremity Arm soreness starting around 7:00 pm day of shot. Headache, fatigue, muscle aches starting 3:00 am, ... Read more
Arm soreness starting around 7:00 pm day of shot. Headache, fatigue, muscle aches starting 3:00 am, lasting until 9:00 pm, the day after receiving the second COVID vaccine shot. Took Tylenol at 1:30 pm and 7:30 pm the day after shot.
59 2021-04-15 pain in extremity sore right arm, fever, fatigue, nausea lasted 4 days, unable to get out of bed or eat due to nausea,... Read more
sore right arm, fever, fatigue, nausea lasted 4 days, unable to get out of bed or eat due to nausea, which led to dehydration.
59 2021-04-15 tingling Tingling in scalp and hands/fingers, both hands, was unable to make a fist without effort - lasted f... Read more
Tingling in scalp and hands/fingers, both hands, was unable to make a fist without effort - lasted for about 5 mins.
59 2021-04-15 tenderness, tremor, tingling, burning sensation, hot flush, muscle twitching Symptoms within a few minutes of vaccine administration: body aches and headaches (although these tw... Read more
Symptoms within a few minutes of vaccine administration: body aches and headaches (although these two specifically are not uncommon for pt), jaw pain, left arm shaking until bedtime that night, twitching (also not uncommon for pt per seizure disorder). Symptoms resolved by next morning at 7am, but within 2 hours, symptoms returned, including swollen face that is painful to the touch, intense fatigue, burning/throbbing/tingling sensation in arms and legs, worsening of arthritic pain, jaw pain, chills/hot flash-like episodes, decreased appetite, stinging sensation in the eye, home measurement had pulse ox 98% and HR at 93 bpm (pt endorsed). Note that pt was COVID positive on Dec 1st, 2020
59 2021-04-16 flushing, tingling, tremor Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient waited in the observation area after getting vaccinated for 15 minutes, went home and started feeling anaphylactic symptoms around 30 minutes after and drove back to the pharmacy to seek medical attention. She was panicked and hyperventilating upon arrival and I had the patient sit down and to take deep breaths. I was about to give her benadryl but she complained of swollen throat and having a hard time breathing. I injected her with epi-pen and within 5 minutes she was better.
59 2021-04-16 numbness 59 yo female with h/o HTN and allergy (shellfish and chorine) who received the Pfizer vaccine. About... Read more
59 yo female with h/o HTN and allergy (shellfish and chorine) who received the Pfizer vaccine. About 10 minutes later, she c/o lips and nose numbness. Several minutes later she c/o hands itching followed by soft palate itching, followed by face( B/L maxillary region)- itching/numb. At this point she had been with us for 30 mins so we gave Benadryl IN 50mg. She told us that she had chest tightness and racing heart with her lips/nose became numb. She maintained no SOB or DIB. BP 142/92 HR 80. One hour later she again c/o chest tightness and left side of tongue burning. Other symptoms had resolved. EMS called. EMS checked BP 124/82. EKG NSR and O2 sat 100%. She was taken to Hopsital. She was in no apparent distress.
59 2021-04-16 pain in extremity I have Rheumatory arthritis and since my second shot I have had a major flare up. Five days after th... Read more
I have Rheumatory arthritis and since my second shot I have had a major flare up. Five days after the shot I have developed swelling and unable to use my right arm and hand also extreme rib pain. It has been many years since ive had such pain. I also have a broken heel (unheeling due to arthritis} that has become very painful
59 2021-04-17 feeling jittery, weakness, inability to speak, feeling hot Immediately felt warm sensation flow from upper body to lower.I said something is happening. Felt ji... Read more
Immediately felt warm sensation flow from upper body to lower.I said something is happening. Felt jittery, flutter in chest and scared. Felt weak like I would pass out. Felt distant from Emt and nurse . Had difficulty getting words out. After about 7 minutes emt took me to his area ck bp it was 130/70. I know it would have been lower had he taken it sooner. I drank 3 waters stayed about an hour after injection.
59 2021-04-17 numbness Facial swelling and numbness
59 2021-04-17 numbness She is out of breath when she is talking; Can hardly take the pain/all muscles seem to be hurting/th... Read more
She is out of breath when she is talking; Can hardly take the pain/all muscles seem to be hurting/things really started to hurt in the group of muscles; She started getting bad/shw was awful/she thought she was dying; Vaccine in the right arm, which swelled up for a while; Pinched nerve under my arm sometimes/she has pinching nerves too underneath her arm underneath her underarms; It will go numb (both arms); This is a spontaneous report from a contactable consumer (the patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 24Mar2021 16:45 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunization. Medical history included ongoing spinal stenosis (is in the very bottom of her back and she had three back surgeries, one surgery in the middle of her back, one is the neck and one on the bottom of her back and this is years in the making), ongoing diabetes, fall on 01Feb2021 or 29Jan2021, she fell and her arms were outside and caught her fall and the underarms hurt and she fell onto her breast hard; according to the HCP she had a look and said she pulled the muscles and this is ongoing. She stated that the muscles would be across the top shelf of her breast above the start of cleavage and under her arms on the outer sides of her breast, underneath her shoulder blades and to her spine things are getting better but she was not perfect and is still hurting and now is lucky if she can reach to grab her diet soda; overweight from an unknown date, and tooth infection from Mar2021 (probably about 6 days before getting the vaccine and is taking Clindamycin 300mg capsules and takes it three times per day). There were no concomitant medications. The patient stated she had the first dose of the vaccine on 24Mar2021 and she is supposed to get the second dose on 07Apr2021. She stated she had the vaccine in the right arm which swelled up for a while (in Mar2021) and next day was fine. By Saturday (27Mar2021) things really started to hurt in the group of muscles. By Sunday (28Mar2021), she could hardly take the pain and went to the HCP on a Tuesday. The pain totally changed. All muscles seem to be hurting, pinched nerve under her arm sometimes. Sometimes it will go numb (both arms). Above T11 and 12 by 1 or 2 places that it would go numb. When she lays down it goes away for a while. When she sits up, it is painful. She reported she has never experienced pain like this. This was worse than her fall. Her doctor thought things were exasperated by the vaccine and she was given prednisone. She also took Tylenol#3 every 8 or 9 hours. She was wondering since she is scheduled on 07Apr2021 for the 2nd vaccine if she should take the shot and how to know if she should or not do this to do more pain to herself. She stated that the pain was enough to make her cry and she has pinching nerves too underneath her arm and underneath her underarms the pain goes down if it gets really bad. She stated she saw her primary care HCP after she got the COVID Vaccine and she wanted to go to the emergency room but she figured they would give her some type of medication so she went to see the HCP and waited two days to see the doctor. On a Saturday, 27Mar2021, she started getting bad and then Sunday, 28Mar2021, she was awful and then on Monday 29Mar2021, she thought she was dying and saw the doctor on Tuesday, 30Mar2021. She also stated she is out of breath when she is talking on an unspecified date. The outcome of the event "vaccine in the right arm, which swelled up for a while" was recovered on an unspecified date, and unknown for other events.
59 2021-04-17 pain in extremity Congestive heart failure; Chronic obstructive pulmonary disease; congestive heart failure and chroni... Read more
Congestive heart failure; Chronic obstructive pulmonary disease; congestive heart failure and chronic obstructive pulmonary disease; Arm was killing her all the way down/her arm hurt so bad/ left leg hurts from her knee to her hip; Chills; Headache; Left leg hurts from her knee to her hip; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Lot Number: ENB207), via an unspecified route of administration, administered in right arm on 19Mar2021 08:00 AM (at the age of 59-year-old) as single dose for COVID-19 immunization. Medical history included asthma since 1990, obese since 1990, Congestive heart failure about 4 years ago in 2017, Chronic obstructive pulmonary disease since 1989; all were ongoing. She had a chemical exposure in a small town that started the COPD since about 1989. Concomitant medications were not reported. The patient previously received fluzone on unspecified date for flu vaccine and caused COPD exacerbation, she was given doxycycline and prednisone with that. The patient is calling about the Pfizer Covid 19, her first dose she received on 19Mar2021. She isn't going to take the second Covid 19 vaccine. On 19Mar2021 at 7:00PM on the day she received her Covid 19 vaccine her arm was killing her all the way down/ arm hurt so bad she wanted to cut it off. That lasted the whole next day and she took 2 Tylenol arthritis pills. Her arm was real sore the next day but it wasn't paining her like it was that first day. It was still a little sore but not like it was. The pain was down the whole arm. Last week (on unspecified date in Mar2021), she started getting headaches and chills. She'll get a chill and the chill will go away. Then a couple hours later the chills will come back. Her headache comes and goes. She checked her blood pressure and her blood pressure is normally low, she checked it and it was 117/76 in 2021. She knew her blood pressure wasn't causing her headaches. And she checked her oxygen level on unspecified date in 2021 and it was good. She normally does not have headaches. She's on 4L of oxygen because of congestive heart failure and chronic obstructive pulmonary disease. Her breathing has been, she can't describe it. Her doctor prescribed some steroids yesterday, 30Mar2021. She is asking if this is normal after 2 weeks. When asking her about her breathing she reports it's like her chest is tighter and she has shortness of breath. If she moves, her oxygen level on unspecified date in 2021 drops with the slightest little movement. Her oxygen has been dropping into the 70s and she has to do the pursed lips breathing to recover. It's taking a while to recover. She has to really work to get her oxygen back into the 90s. That started last week some time. She did call her doctor and her doctor prescribed prednisone and doxycycline (Prednisone 4, 10 mg tablets for 3 days, then 3 tablets for 3 days, then 2 tablets for 3 days, then 1 tablet for 3 days and Doxycline Hyclate 100mg 1 capsule twice daily for 7 days). She forgot to mention that her left leg hurts from her knee to her hip on unspecified date in 2021. That started a couple days ago. She didn't have any problems with her hip before. She's scared because the second vaccine is more potent, it's worse. She doesn't know if she's going to get that second Covid 19 vaccine. The outcome of the events was not recovered.
59 2021-04-18 burning sensation, numbness and pain in extremities Severe neuropathy and burning in both feet for about 3.5 weeks
59 2021-04-18 hot flush Flu like symptoms with fever of 101° for over a week. Now continue to have joint pain and EXTREME H... Read more
Flu like symptoms with fever of 101° for over a week. Now continue to have joint pain and EXTREME Hot Flashes that feel like I am in menopause again!
59 2021-04-18 pain in extremity left shoulder and left armpit pain.
59 2021-04-18 pain in extremity 4/14-vaccine. Stiff neck, sore left base of skull, beginning w/in 1 hour. Painful arm barely lift-a... Read more
4/14-vaccine. Stiff neck, sore left base of skull, beginning w/in 1 hour. Painful arm barely lift-able by 9 PM, largely resolved w/ 48 hrs. 4/16, AM awoke w/intense pain in buttock and down leg to knee when trying to walk or crawl. Right and left low back pains. 2 days in bed with ice, Tylenol, CBD balm, diclofenac. By 4/18, able to shuffle. Right buttock soreness. 4/19 cautious walking. Burning in right buttock, off and on. 4/19-Very sore base of skull both sides, stiff and sore right jaw, ear fullness, numb teeth, headache. Anxiety treated w/ herbs, Tylenol for pains, herbal balm for pain.
59 2021-04-18 pain in extremity Gillion bar syndrome, spinal tap confirmed on April 17, 2021 Pain started in her back in April 10th... Read more
Gillion bar syndrome, spinal tap confirmed on April 17, 2021 Pain started in her back in April 10th 36 hours after shot went down her back to but and legs. Friday April 16,2021 she could not walk. Hospital on the 16th by the 17th her arms and hands were affected. Still in the hospital to current date receiving IVIG to see if that will work for her.
59 2021-04-18 pain in extremity Vaccine mixed with incorrect diluent (sterile water instead of normal saline). Pt informed of error ... Read more
Vaccine mixed with incorrect diluent (sterile water instead of normal saline). Pt informed of error and offered revaccination. Pt reports sore arm with onset about 5 days after vaccination that lasted about 15 days.
59 2021-04-18 tenderness On Wednesday, 04/14/2021, noticed a warm and very sore three (3) inch rash near the injection and it... Read more
On Wednesday, 04/14/2021, noticed a warm and very sore three (3) inch rash near the injection and it remained sore to touch for three (3) days. On Saturday, 04/17/2021, the arm rash was barely visible and not sore at all.
59 2021-04-19 flushing "Administered - 09:58 Adverse event started - 10:15 Patient had hives, flushing/sweating. BP 118/54... Read more
"Administered - 09:58 Adverse event started - 10:15 Patient had hives, flushing/sweating. BP 118/54, HR 83, RR 18, O2 92%. Given 0.3mg EpiPen at 10:25, 911 called at 10:30, patient taken to emergency room."
59 2021-04-19 migraine Chronic migraine headaches.
59 2021-04-19 migraine I had no reaction to shot #1 other than a slightly sore arm. After 36 hours and 12 minutes, I was a... Read more
I had no reaction to shot #1 other than a slightly sore arm. After 36 hours and 12 minutes, I was awakened with a migraine, which I have now had for 10 days. I tried treating with OTC, guafesin, and netti pot and it has only minimally improved my headache. I visited the doctor today and he said there is inflammation in my sinuses and behind my ear drum. He prescribed a 5 day-dose of Prednisone (reducing by 1 each day) to see if that will alleviate the inflammation and my headache. Outsome unknonwn at this time.
59 2021-04-20 involuntary muscle movements Left neck adenopathy/mass with pain, limited ability to open the mouth. Solumedrol IM and oral bene... Read more
Left neck adenopathy/mass with pain, limited ability to open the mouth. Solumedrol IM and oral benedryl provided, patient sent to ED for observation, management
59 2021-04-20 facial paralysis, bell's palsy Bell's palsy diagnosed, left side facial paralysis, treated w/ prednisone and acyclovir. Still affec... Read more
Bell's palsy diagnosed, left side facial paralysis, treated w/ prednisone and acyclovir. Still affected. Previous history of Bell's palsy on opposite side (2014).
59 2021-04-20 flushing Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (s... Read more
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: rash all over body, low grade fever and chills
59 2021-04-20 numbness Patient complains of left sided facial numbness, right arm numbness. Progression of symptoms to left... Read more
Patient complains of left sided facial numbness, right arm numbness. Progression of symptoms to left are. Patient reports numbness comes and goes. However, numbness to left side of face/upper lip remains constant. Patient refused treatment/transport despite clear clnical findings of neurologic dysfunction and sighed release paperwork and left facility with her son.
59 2021-04-21 difficulty speaking, numbness Chief Complaint: ? Care Coordination ? Immunization/Vaccine Administration ? Tongue Swelling a 59 y.... Read more
Chief Complaint: ? Care Coordination ? Immunization/Vaccine Administration ? Tongue Swelling a 59 y.o. female with PMHx of HTN, Anxiety, well controlled T2DM and obesity who presented today to receive her first COVID Vaccine. Denies hx of anaphylaxis due to any cause. First COVID Vaccine administered in RD at 9:53 AM 13 min after the vaccine was administered she informed my CMA that she was having throat thickness, tongue swelling and watery eyes. I immediately completed vitals: BP: 178/100 Pulse: 76 RR 16 SpO2: 97% 10:13 am I moved her into my exam room. She stated that within 2-3 min of receiving the vaccine she began experiencing "throat thickness", dry mouth and tongue "thickness" but the symptoms had not progressed. She also c/o postnasal drip and a horse voice. She also c/o watery eyes and swelling around eye but states she had the watery eyes this morning prior to the vaccine. She also c/o numbness of a small area of her left wrist. She has significant environmental seasonal allergies for which she takes Claritin each morning and uses Flonase and montelukast each evening. She ran out of Claritin so she did not take one this morning. All of her symptoms are consistent with her normal environmental allergy symptoms she has been having off and on the last few weeks. She states they just all flared up about 2 min after the vaccine was given. She also states she did not take her BP medication this morning. She states she was very stressed out getting her today because she got lost and thought she would be late. Admits to feeling anxious. Denies hives, itching, difficulty swallowing, throat closing sensation, shortness of breath, chest pain, difficulty breathing, lightheadedness, dizziness, n/v/d, abdominal pain, wheezing, headache. 10:22 am States she has a slight headache but otherwise symptoms are stable Completed physical exam - unremarkable. No stridor, no lip/tongue/posterior pharynx swelling I reviewed her medication list 10:27 am Repeat vitals: BP: 178/102 Pulse: 72 RR 16 SpO2: 99% 10:36 am I continued to monitor her, I completed serial vitals and physical exams as well as continuously asked how she was feeling and doing. She denied difficulty breathing, wheezing, worsening of symptoms, chest pain, lightheadedness, palpitations. I advised giving her liquid benadryl only if she could have someone come pick her up. She declined stating that she did not have someone that could drive her home. She lives 20 min away 10:40 am She states that the eye swelling has resolved and the throat thickness was improving. Her slight headache has resolved. I advised we monitor for another 30 min here in the clinic. 11:10 am She states she is feeling much better. She reports her tongue and throat feel back to normal. Headache has resolved. She denies any difficulty breathing, wheezing, lightheadedness, dizziness, n/v/d, hives, itching, palpitations, throat/tongue itching. Rechecked vitals and physical exam. Vitals (75 min after vaccination) BP: 176/98 Pulse: 78 RR 12 SpO2: 98% ROS: Constitutional: Negative for fatigue, diaphoresis and weakness. Eyes: Negative for blurred vision, eye pain and photophobia. Watery eyes E/N/T: Positive for congestion and hoarseness. Negative for rhinorrhea, odynophagia, stridor and tinnitus. Throat and tongue thickness Cardiovascular: Negative for chest pain, palpitations, tachycardia, edema, dyspnea on exertion, irregular heartbeat and near-syncope. Respiratory: Negative for cough, shortness of breath, wheezing and sputum production. Gastrointestinal: Negative for abdominal pain, diarrhea, stool changes, nausea and vomiting. Integumentary: Negative for dry skin, pruritus, rashes, dry skin and flushing. Neurological: Positive for headaches. Negative for dizziness, weakness, focal weakness, light-headedness and vertigo. Allergic/Immunologic: Positive for environmental allergies. Negative for frequent illnesses, urticaria, hives and persistent infections. PMH: Diagnosis Date ? Abnormal mammogram ? Anxiety ? Essential hypertension, benign ? High cholesterol I reviewed the following historical information during this visit: Tobacco | Meds | Problems | Med Hx | Surg Hx | Fam Hx | Soc Hx OBJECTIVE: Vitals (75 min after vaccination): BP: 176/98 Pulse: 78 RR 12 SpO2: 98% Temp: 97.1 PHYSICAL EXAM CONSTITUTIONAL Vitals reviewed. GENERAL APPEARANCE: Well-developed and obese. GROOMING: Well groomed. LEVEL OF DISTRESS: The patient is nervous/anxious. The patient is not distressed or diaphoretic. She appears to be well. The patient is not lethargic or toxic. The patient does not appear tired. EYES: LIDS/CONJUCTIVA:Positive for Bilat/clear eye drainage.Negative for eye lid edema. No lid edema, no surrounding facial edema Conjunctiva are minimally pink, no erythema PUPILS/IRIS: extraocular movement intact. ENT EXTERNAL EARS/NOSE: External ears and nose are normal. SEPTUM/MUCOSA: Turbinates are mildly swollen. Negative for edematous mucosa, sinus tenderness and pale, boggy nasal mucosa. LIPS/TEETH/GUMS: Normal lips, teeth and gums. No lip edema. OROPHARYNX: Oropharynx normal. Mucosa: Mucosa appears normal. No tongue edema, erythema or rash noted No oropharynx or posterior pharynx swelling noted She is swallowing and breathing normally No stridor NECK: Neck normal. RESPIRATORY EFFORT AND PATTERN: Effort normal. No tachypnea, intercostal retractions, accessory muscle usage, hypopnea and irregular rate. AUSCULTATION: Normal breath sounds with no rales, rhonchi, wheezes or rubs. No inspiratory wheezes, expiratory wheezes or stridor. CARDIOVASCULAR AUSCULTATION: Rate: Is normal. Rhythm: regular. Heart sounds: S1 is normal. S2 is normal. S3/S4 not present. With no murmurs heard. EDEMA/VARICOSITIES: No edema or varicosities. RADIAL: radial pulses normal bilaterally PEDAL PULSE: Normal bilateral posterior tibal pulses. LYMPHATIC OTHER NODES: No neck adenopathy. No supraclavicular or submandibular nodes.Supraclavicular INTEGUMENTARY SKIN INSPECTION: Normal. ECZEMA/PRURITIC CONDITIONS: Negative for urticaria. Skin temp and color normal, no flushing, no diaphoresis, no urticaria Injection site is unremarkable NEUROLOGICAL CRANIAL NERVES: Cranial nerves normal. CN grossly normal GAIT, COORDINATION, REFLEXES Gait: normal PSYCHIATRIC ORIENTATION: She is alert and oriented to person, place and time. MOOD/AFFECT: Appears anxious. Does not appear agitated or depressed. She is not argumentative. She does not act disrepectful, act distrustful or have a flat affect. INSIGHT/JUDGEMENT: Normal insight/judgement. The patient has good insight with good judgment. ASSESSMENT/PLAN: Environmental allergies - Symptoms were consistent with her normal environmental allergy flare ups. - She did not take claritin this morning as usual so this may be why the allergies flared up - Symptoms resolved within 70 min of giving the vaccine without any therapy - I recommended giving liquid benadryl and having someone come pick her up and monitor her at home. She declined stating that she did not have someone who could pick her up and stated that she would rather take benadryl at home. - She stated she felt safe to drive home. I gave strict warnings that if any sx recurred or if any new or concerning symptoms developed that she should call 911. Reviewed signs and symptoms of anaphylaxis. - I advised she take liquid benadryl when she got home and have someone monitor her for the next 4 hours. Essential hypertension - elevated today likely due to increased stress/anxiety and not taking BP medication this morning - I advised that she monitor her BP closely at home. I advised she take her BP medication when she got home if her throat felt normal. - recommended f/u with PCP Encounter for administration of vaccine First Pfizer COVID Vaccine given today I recommended she consult with her PCP about the second vaccine. She expressed understanding and all questions answered. ----------------------------------- Called patient at 2:10 pm to check up on her. She states that she took liquid benadryl about 40 min ago and that all of her symptoms have completely resolved. She states that she is feeling great now. She denies difficulty breathing, throat swelling/tighntess/thickness, tongue swelling, wheezing, headache, n/v/d, lightheadedness, hives, itching, palpitations or chest pain. She states she took her BP medications but has not checked her BP at home yet. I recommended she continue taking benadryl as needed and recommended she follow up with her PCP in 1-2 days. --------------------------------- Patient's PCP) I wanted you to be aware that your patient had a mild reaction vs flare up of her environmental allergies after her first COVID Vaccine today. I called her 4 hours after the vaccine. She had taken benadryl at home and her symptoms had resolved. I was hoping to consult with you about her receiving her second vaccine. Her BP was elevated. She had not taken her BP medication this AM. I recommended she also f/u with you on that as well. --------------------------------- Dr's response "People react to making antibodies. The serious anaphylaxis is rare. Most are having general side affects and flu-like symptoms I would like you to administer the 2nd vaccine. Notes seen on morning of April 20. Responded."
59 2021-04-21 pain in extremity Arm got real sore by evening. During the night I came down with the chills, extreme headache and bo... Read more
Arm got real sore by evening. During the night I came down with the chills, extreme headache and body aches all over. Some nausia, had a mild earache and sore throat along with fever. Had a little bit of an appitite. Earlier today (11:30 AM) I took two dayquil which took approx 1-1/2 hours b4 body aches, etc subsided a bit. Felt ok for a couple of hours. Its now 5:00PM and I'm feeling at my worst.
59 2021-04-21 pain in extremity Headache, chills, sore arm, body aches
59 2021-04-21 tingling, numbness right arm intermittent numbness and tingling down to them, index and middle finger
59 2021-04-21 speech disorder Very bad headache , dizzy now I am not talking right. Have not feel right since. Arm is still red a... Read more
Very bad headache , dizzy now I am not talking right. Have not feel right since. Arm is still red and swollen
59 2021-04-22 weakness Normally I take a Coreg CR 20 mg @9am, and another one @9pm; blood pressure (BP) was well controlled... Read more
Normally I take a Coreg CR 20 mg @9am, and another one @9pm; blood pressure (BP) was well controlled for the last 5 years. The day of the 2nd COVID dose I started feeling malaise/weakness around 7-8pm. My BP was 188/106 (3 measurements average). Took the 9pm Coreg at 8pm; didn't feel improvement, my BP increased to 220/118. I took a Labetalol 100mg; in about 2-3 hrs my PB came down to 170/105 and I fell asleep. I woke up several times feeling sick. The next day my BP was higher than usual around 170/112 (in the morning I felt a bit better; but started to feel very sick again in the afternoon; it continued in the evening & during the night). I felt as if my heart was giving up. The only reason I did not go to Emergency was the fear I can get the COVID in the hospital. THIS WAS A VERY SERIOUS, LIFE THREATENING EVENT; if I didn't have Labetalol in the house I believe I would be dead now. Note: I did not panic, my pulse was around 66 the first day. The second day it was around 72. There should be an investigation covering the side effects in people with a high BP history after the 2nd vaccine dose, to make sure their problems were not blamed on their health history. During the side effects/time frame I described, it seemed my BP medication did not have the effect it usually has on me. I found it unacceptable that the only site reporting the spikes in BP as a COVID vaccine side effect was a hospital in another country; if there were such side effects reported by the date of my vaccine, they were not readily available for the public. These heart problems could have been made much better if people like me knew of an increase in BP as adverse reaction to the vaccine's 2nd dose, so we could have been prepared, i.e. take the BP medication BEFORE the BP spikes up so much, so it doesn't reach critical values (especially in the conditions of malaise and general sickness given by the vaccine.)
59 2021-04-22 difficulty speaking, flushing wheezing, dizziness, lightheadedness, fatigue, GI distress, hoarseness, Stridor, muscle/joint aches,... Read more
wheezing, dizziness, lightheadedness, fatigue, GI distress, hoarseness, Stridor, muscle/joint aches, skin redness/rash, nausea, vomiting, flushed skin, blurred vision
59 2021-04-22 feeling hot, flushing, numbness, tingling HPI: Patient is a * year old * who presents following administration of the first dose of Pfizer COV... Read more
HPI: Patient is a * year old * who presents following administration of the first dose of Pfizer COVID19 vaccine in the left deltoid. She states that immediately following vaccination, she felt a rushing feeling in the left side of her face, particularly the left ear, and left arm. She further describes constant warmth, numbness and tingling in the left ear. She denies muscle weakness, headache, changes in vision, and loss of consciousness. She states she has never experienced these symptoms following a vaccination. She also states she has not eaten this morning, but has drank water. She affirms a history of childhood allergic reaction to sulfa drugs, however, she does not recall what the reaction was. She denies a past medical history. She denies taking medications on a regular basis. She denies chest pain, difficulty breathing, difficulty swallowing, other skin changes/urticaria, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. Exam: GEN: Alert and oriented x 4, NAD HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: Erythema and warmth of the left pinnae. No rashes, skin warm and dry. No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady Clinical Impression/Field Tx: Flushing of the left ear following vaccine administration. Patient otherwise not displaying signs or symptoms of anaphylaxis. Thorough neuro exam performed and was within normal limits. Patient demonstrated the ability to adequately control the airway and secretions. Vital signs stable. Patient felt as if the sensations were decreasing by the end of the evaluation and felt comfortable driving home. Instructed patient to consult their PCP regarding the post-vaccination reaction. Patient instructed to go to emergency department should they develop chest pain, difficulty breathing, difficulty swallowing, muscle weakness, vision changes, adverse skin changes, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting. Medications administered: None Disposition: Home
59 2021-04-22 numbness Patient reported a low grade fever and face/tongue numbness beginning 1 hour post-vaccination. She r... Read more
Patient reported a low grade fever and face/tongue numbness beginning 1 hour post-vaccination. She reported no difficulty breathing, but noted that eating and drinking was bothersome. No swelling/redness. Referred to the local urgent care for follow up.
59 2021-04-22 tingling Fevers, chills and sweating, joint pains, muscle aches, headaches, pins and needles in hands and fee... Read more
Fevers, chills and sweating, joint pains, muscle aches, headaches, pins and needles in hands and feet, extreme fatigue
59 2021-04-22 tingling Woke up around 11:30 pm with pins/needles sensation inside my torso, not on my skin. Lasted through... Read more
Woke up around 11:30 pm with pins/needles sensation inside my torso, not on my skin. Lasted throughout the night. Gone by 6am. Heart racing, but not sure if that was because of the shot or my reaction to pins/needles sensation. Also had itching on my torso and arms throughout night and next day (4.22). There was no rash at anytime.
59 2021-04-22 speech disorder Patient reported Shortness of Breath, trouble speaking in full sentences. Vitals within normal limit... Read more
Patient reported Shortness of Breath, trouble speaking in full sentences. Vitals within normal limits, Pt was transported to local hospital via EMS was treated and released for an allergic reaction.
59 2021-04-22 tremor Upon going to bed, I experienced severe chills and shaking for 5 hours. Also severe headache, jaw, ... Read more
Upon going to bed, I experienced severe chills and shaking for 5 hours. Also severe headache, jaw, body and neck pain. Lymphnodes were swollen. Body aches; fever and nausea and fatigue. This lasted until 8 pm the next day (4/22). I am still experiences chills, fever, nausea, fatigue and general malaise as of 4/23/2021
59 2021-04-23 weakness Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium, Additional Details: All vital... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium, Additional Details: All vitals were stable; eyes were responsive to light; blood sugar also when checked was stable; we called EMT and they aslo checked her vitals and still everything was within normal limits. She was taken to hospital by ambulance for more observation.
59 2021-04-23 discomfort, pain in extremity Annoying armpit pain, still have 3 days later. Very strong pain at shoulder blade area going all th... Read more
Annoying armpit pain, still have 3 days later. Very strong pain at shoulder blade area going all the way to the front. It feels like something is wrong with my lungs and my spine. Pain is much worse when inhaling. Sometimes makes me cough. I had back pain after the 1st shot, and was finally getting better. Now it is back in full force but only between shoulder blades. Constant pain, sometimes get worse, sometimes better but never goes away. Neck pain, and hard to move neck; now getting better. I had first shot in left arm and second in right arm. After 2nd shot my Left arm (the one that got 1st shot) started being sore and i was not feeling anything in the right arm Where i got the shot. Then it finally switched with the added "bonus" of the armpit pain. I was very very tired fist day but then could not sleep for the next two nights Due to back pain and general discomfort. After 2 nights of no sleep i was really beaten up , with a minor headache all day ,maybe because of vaccine but also because of lack of sleep. No fever, when i checked 37.3 A bit of chills night 2
59 2021-04-23 numbness On 4-9-2021, pt (community member) came in to receive a covid vaccine. Pt answered health questio... Read more
On 4-9-2021, pt (community member) came in to receive a covid vaccine. Pt answered health questionnaire and was unremarkable, thus vaccine was given after all consents were signed and identity was confirmed with 2 sources. Pt arm was prepared as per policy and procedure. Pt asked, "are you a nurse and what method of vaccination are you going to use?" I told the patient that I am a nurse and that I was going to use the z track method to administer vaccine and then described it. After cleaning the site the patient stated, "wait let it dry and began wafting the site." The patient was told not to do this as waving air toward the site would bring germs to it. The patient's deltoid was then prepared again. The vaccine was administered as per policy and procedure. About 10 minutes after receiving vaccine pt stated she was having eye discomfort but denied other symptoms. The patient was offered oral Benadryl as an anaphylactic response was not apparent. The patient refused the clinic's Benadryl and stated I have my own. The patient was given water and took 25mg of Benadryl by mouth. The patient was also asked to stay 15 to 30 minutes longer for observation as it appeared she was having a mild reaction. Patient was agreeable. Blood pressure was 178/80, heart rate was 78, and oxygen saturation was 95 on room air with a respiratory rate of 18. No signs or symptoms of distress were noted. At 11:00, patient was asked if she felt better. The patient stated yes, but stated having numbness in arm that vaccine was given in. The arm was assessed, patient was able to move arm in full range of motion, capillary refill was less than 3 seconds, and no swelling or redness was observed. The patient then stated, "oh it just must be my muscle." The patient was educated that a sore arm was to be expected and was a common side effect, but if the numbness worsened or diminished function was observed she should go to the Emergency Room. Pt stated understanding. The patient stated, that at this times she needed to go because her daughter had to go to work. The patient was encouraged to stay for more observation, but refused and stated she was feeling better. The patient was told to go to the emergency room if symptoms worsened. Patient was also educated on her blood pressure, as it was noted to be elevated. The patient stated she took her blood pressure medications that morning. The patient was asked to take blood pressure at least 2 more times ( at lunch and dinner time) and if blood pressure remained higher than 170 systolic (on the top number), that she needed to go to the emergency room and consult with her primary doctor. Patient stated understanding. Clinic phone number was provided to patient, in case she had any question or concerns. Patient was able to exit clinic with a steady gain, alert and oriented x3, and with no signs or symptoms of distress noted
59 2021-04-23 numbness Just after having the shot 20 mins, lips started having tingling, 10 mins later face on the left sid... Read more
Just after having the shot 20 mins, lips started having tingling, 10 mins later face on the left side started been numb and it lasted for about an hour.
59 2021-04-23 tingling, flushing Intense face and neck flush; Skin was red, very warm and tingly; Skin was red, very warm and tingly;... Read more
Intense face and neck flush; Skin was red, very warm and tingly; Skin was red, very warm and tingly; Began to have numbness in my lips and tongue; My BP was on the elevated side; skin very warm; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ELI283 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 03:00 PM, as single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism and hypertension. The concomitant medication included toprol, pravastatin, levothyroxine, fish oil, CoQ10. Patient did not take any other vaccine in four weeks. No COVID prior vaccination and no covid tested post vaccination. On 09Feb2021 at 15:15 At about 18 minutes after the vaccine was administered, patient had a sudden and intense face and neck flush, skin was red, very warm and tingly. Patient took benadryl 25 mg tablet and after about 5-10 minutes began to have numbness in lips and tongue. At this point, patient returned to the vaccination site to report this and wait for resolution. Patient was immediately seen by a nurse and EMS and her vitals were taken and was advised to take another 25mg of Benadryl. Patient underwent lab test and procedure which included BP was on the elevated side, O2 sat was normal. Her symptoms improved and by 45 mins after the vaccination she was comfortable returning to home no additional symptoms. The outcome of the patient's events was recovered.
59 2021-04-23 tingling 30 minutes post vaccination adminstration, patient complained of tingling and throat thickening. Pa... Read more
30 minutes post vaccination adminstration, patient complained of tingling and throat thickening. Patient treated with benadryl 50mg by PharmD. Pt refused further medical treatment and stated she thought she was feeling better. Contacted the next day. Patient treated with another dose of benadryl at home and states she is feeling well at this time.
59 2021-04-24 numbness Right side of face, below jaw at neck swelling and numbness, hives all along neck line, stiffness in... Read more
Right side of face, below jaw at neck swelling and numbness, hives all along neck line, stiffness in face on right side for 24 hours. Pharmacist advised that I purchase Benadryl immediately and then contact my doctor and call 911 if I couldn?t breathe.
59 2021-04-24 pain in extremity, weakness SWOLLEN LYMPH NODE NEAR UNDERARM, SOME PAIN-SAME SIDE AS SHOT. (4/21-4/23) LETHARGIC & FEELING ILL, ... Read more
SWOLLEN LYMPH NODE NEAR UNDERARM, SOME PAIN-SAME SIDE AS SHOT. (4/21-4/23) LETHARGIC & FEELING ILL, WEAK, SLOW/DULL BRAIN-EXECUTIVE FUNCTIONING IS LABORED , SOMEWHAT BREATHLESS AFTER SIMPLE ACTIVITY 4/21 AND CONTINUES THROUGH 4/25 (TODAY). TEMP ROLLS FROM 98 TO 99-COMES IN WAVES. LOSS OF APPETITE. VIVID ACTIVE DREAMS. TAKEN SOME ADVIL, TYLENOL PM, BUT NOT CONSISTENTLY.
59 2021-04-24 pain in extremity pain that arm from the injection site down to her hand; whole arm is hurting all the way to the hand... Read more
pain that arm from the injection site down to her hand; whole arm is hurting all the way to the hand and arm started aching; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER2739), via an unspecified route of administration on left arm on 05Apr2021 (at the age of 59-years-old) as single dose for COVID-19 immunisation. Medical history included ongoing asthma (Diagnosed in November or December of 2020 while she had the COVID virus; went for a lung test in January 2021). Concomitant medications were not reported. Patient reports that she did have a hard time when she got COVID virus in 2020. Patient reports she had a lot of breathing problems when she had the COVID virus and she went to a lung specialist and was diagnosed with asthma. Patient reported that she received the COVID vaccine at 5:30 or 6:00 pm on 5Apr2021 and then her arm started aching. She states that to treat the pain, she is putting ice on it and everything but that the pain is not going away. She reports that the pain began around 8:30 or 9pm on 05Apr2021. She reports that she had to take her rings off of her hand because it is hurting so much. Patient reports the pain is staying the same except it gets better when ice is on it and that she is taking ibuprofen to help with the pain as well. Patient states that if she doesn't do ice and ibuprofen the pain is at a 10. Additional Vaccines Administered on Same Date of the Pfizer Suspect Additional Administered Vaccines were none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient was not recovered from the events. No follow-up attempts are needed. No further information is expected.
59 2021-04-24 tingling The evening of my vaccine, my vision became blurry. My hands began to tingle with pins and needles s... Read more
The evening of my vaccine, my vision became blurry. My hands began to tingle with pins and needles sensation. Concerned, I looked up side effects online but all I could find was possible fainting. I did not feel faint, so I continued to monitor myself. I finally fell asleep around midnight. I woke up around 8 still with pins and needles sensation; however, in my left big toe it had subsided. My blurred vision seemed better. Still concerned I called the doctor's office.
59 2021-04-24 tremor Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got... Read more
Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got to 103.5; Blood Pressure was very high; flu like; 1st dose :20Mar2021; 2nd dose: 04Apr2021; 1st dose :20Mar2021; 2nd dose: 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Apr2021 11:00 (Lot Number: EW0150) as single dose (at the age of 59-years-old) for covid-19 immunisation. Medical history included breast cancer, anxiety, depression, irritable bowel syndrome (IBS), Low Thyroid, arthritis. Patient had no known allergies. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Arm Left (Lot number: ER2613) on 20Mar2021 12:00 PM (at the age of 59-years-old) for COVID-19 immunization. It was reported that patient received first dose on 20Mar2021 and second dose on 04Apr2021 (Inappropriate schedule). Patient stated that she had her second (2 nd) shot on 04Apr2021 (Sunday), was fine until 07Apr2021 (Wednesday). On 07Apr2021 at 15:00 she got violent shakes and chills, stomach pain, temperature suddenly got to 103.5. Patient went to Emergency room. Blood Pressure was very high. She was released and better on Friday but still flu like. They could find no reason for this and three doctors (Dr's) thought it was a reaction to the vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 3 days. She was treated with intravenous (IV's), Antibiotics, cat scan and X-ray, results unknown. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 07Apr2021. She was recovering from the events, at the time of the report.
59 2021-04-25 burning sensation, pain in extremity Lightheaded, burning pain radiating from neck up into head. Throat became swollen, did not close but... Read more
Lightheaded, burning pain radiating from neck up into head. Throat became swollen, did not close but felt like breathing through a straw when breathing and felt like I was swallowing something, almost choking on swallowing. Extreme fatigue. On day 2 of arm, neck and head pain.
59 2021-04-25 night sweats chills, night sweats, body aches, fatigue, low grade fever, sore throat
59 2021-04-25 pain in extremity Initially just a sore arm and itching and then each day progressively worse dizziness headache eye p... Read more
Initially just a sore arm and itching and then each day progressively worse dizziness headache eye pain nauseated swollen lymph glands difficulty breathing now 2 weeks!
59 2021-04-26 weakness Muscle pain & weakness started at bed time on day of vaccination. Woke up next morning still in pain... Read more
Muscle pain & weakness started at bed time on day of vaccination. Woke up next morning still in pain with chills. Slept from noon on 2nd day until 7:00 a.m. the next day, then slept off/on all day & night until the following morning. The muscle pain had mostly subsided when I began to notice more pain in my left shoulder (the injection side) & armpit. My armpit/lymph nodes swelled throughout the day, so I used warm/moist compresses and Tylenol to help alleviate the pain. That was yesterday, and today the area remains painful & I'm continuing my home treatment of compresses & Tylenol.
59 2021-04-26 depressed level of consciousness decrease level of consciousness
59 2021-04-26 discomfort, pain in extremity, speech disorder First day tired and slight headache 2 day arm hurt badly and headache more intense very tired 3 day ... Read more
First day tired and slight headache 2 day arm hurt badly and headache more intense very tired 3 day arm hurts more headache bad and very very tired 4 day woke up at 3:45 am and I couldn?t walk straight and my left side of body was very heavy and my speech was off and my head hurt really really bad and seemed to be on my left side of my head and my neck hurt extremely bad I went to hospital
59 2021-04-26 facial pain My mouth got sore and I had a headache. Now I have several sores in my mouth and my right cheek is ... Read more
My mouth got sore and I had a headache. Now I have several sores in my mouth and my right cheek is sore. It is uncomfortable to eat.
59 2021-04-26 pain in extremity, feeling cold pt says she when she woke up she was dry heaving and severe headache. She had chills, diarhea, naus... Read more
pt says she when she woke up she was dry heaving and severe headache. She had chills, diarhea, nausea, skin was slightly red and peeling. She had vertigo, sore throat, dry mouth, loss of taste, fatigue, muscle aches and pains. Her right arm hurt more than the left arm where she had the arm that was injected. She had major hair loss and trouble focusing and feels like she has a sinus infection. Patient is taking cold and flu meds. She does feel some better but still has a headache and feels like she has a cold.
59 2021-04-26 pain in extremity Metallic taste in my mouth. Arm very sore like someone punched me.
59 2021-04-26 pain in extremity Tiredness, headache, muscle pain, chills, fever, stomach pain, redness, pain and swelling in area
59 2021-04-26 pain in extremity Pt called center on 4/19/21. Pt has history of MVR on warfarin. Pt c/o Right side leg pain only th... Read more
Pt called center on 4/19/21. Pt has history of MVR on warfarin. Pt c/o Right side leg pain only that started 04/17/2021 and about 4cm bruise in between foot and knee area started on 04/16/2021. Pt took tylenol today an hour ago from call with right side leg pain relief. Can able to walk but slowly. Strongly urged patient to go to nearest ED for further evaluation and treatment but pt refused and stated will talk to doctor first via phone. Scheduled MD available earliest telephone f/u appointment 4/17/21 at 8pm as per pt request. Advised patient and her daughter to call 911 or go to ED if any emergency sx arises anytime, both assure understanding. PT also schedule visit with provider.
59 2021-04-26 pain in extremity Blood pressure was high, pain in left arm, lump and pain on my left shoulder blade, chills and low ... Read more
Blood pressure was high, pain in left arm, lump and pain on my left shoulder blade, chills and low grade fever. I took Tylenol and the chills and fever went away Friday night, The pain in my arm went away by Sunday, 4/25. My blood pressure went down after drinking more water. I can still feel the lump but its not as painful.
59 2021-04-26 tremor, migraine, weakness to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular p... Read more
to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular premature beat); Large black bruise on left breast; 40 hrs fever; throwing up/vomiting; nausea 36 hours; intermittent breathing issues/sporadic breathing issues/difficulty breathing and hard to get a breath; She was weak; severe migraine; Headache; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number ER8727, expiration date: 31Jul2021), via an unspecified route of administration in arm left on 07Apr2021 12:00 as single dose for Covid-19 immunisation. Medical history included allergy ( macro Danton, sulfa). Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medication included Nerontin. The patient reviously received flu vaccine and had normal things, previously received first dose of bnt162b2 (Lot Number: EN5318; Expiration Date: 31May2021) in arm left on 17Mar2021 16:00 and experienced acute lymphatic response, brain fog and arm started to hurt. The pateint was calling because her doctor, who she saw yesterday 14Apr2021, told her she should let Pfizer know what was going on. She had a reaction to the Pfizer Covid19 Vaccine. she was now having PVCs. The patient added that all of the events started with a fever, and throwing up. She had a fever and threw up for 36 hours. She had to contact her physician to get medication and to stop vomiting and the nausea and everything. During that time, she was sick. She was having intermittent breathing issues which she did not think she felt too much of until after the other sickness was over. She was weak, like people get after they are sick, and had bizarre shaking legs and arms which was strange. She added that she had breathing issues and difficulty breathing and hard to get a breath. That was what she was dealing with. Treatment: caller took Pedialyte and all the proper things to get back into better shape. The breathing issue still remained. The doctor called in a rescue inhaler. She kept going downhill so he called in a rescue inhaler. Large black bruise on left breast after second vaccine: Caller added that this one will not be believed but on Monday, she woke up and got dressed again and was just weak and had breathing issues but was just doing work on the laptop. She did not fall, she did not run into anything. In the evening, she went to take a bath and saw that when she took her clothes off there was a large black bruise on her left breast, it was probably 2 inches in diameter. It is very large, but does not hurt like a bruise. She checked the rest of her body for blood issues and only saw a couple normal looking bruises. She contacted her doctor, and they questioned her thoroughly on her bruising and activity. This was on Monday. Tuesday, she still felt the same headache, weak, and breathing issues. PVCs (Ventricular premature beat) after second vaccine: Yesterday, 14Apr2021, she started declining and the doctor wanted to see her. Caller stated the doctor heard PVCs in her heart. Caller asked clarification of PVC abbreviation and does not provide. She never had heart issues ever. The doctor did blood work and a chest x-ray, and saw the bruise and was worried about her blood. Caller added that even though these are not listed as side effects of the vaccine, she was worried. Her doctor sent her to a facility for chest x-rays to make sure there is no pulmonary embolism. Caller confirmed this was on 14Apr2021. She has not yet heard back. PVCs after second vaccine: Caller added the doctor said her lungs sounded good but wanted to see what was going on to see how her breathing was because there was difficulty. The doctor wanted to cover bases and check. Today, caller can tell her heart is still not in correct rhythm and that it is in continued PVCs. She still had the same breathing issues, limbs were weak, she was shaky, and she is lightheaded. She was hoping to wake up today and feel better. Fever after second vaccine: started 3am 08Apr2021. She had a fever and was throwing up at this time. Throwing up and nausea after second vaccine: caller add that throwing up and vomiting with nausea occurred at 3 am, all of this occurred 08APR2021. The vomiting lasted 36 hours, and it ended when she took medication. The fever lasted 40 hours. Even after the medication worked for her fever, she had nausea. Around Friday was when it went away. Intermittent breathing issues after second vaccine: caller adds it started with throwing up and fever, but she did not think a lot about this or know when it started because she was dealing with the fever and vomiting. It continued, and it has not subsided or ended. As a matter of fact, there are 2 or 3 times it has gotten bad which is why she was given an inhaler. Treatments: caller took a Phenergan suppository, which she adds is the best medicine in the World for nausea and beats Zofran. She had used two or three doses and it did work. She used a rescue inhaler, Albuterol Sulfate HFA. She took Tylenol for fever. She is also now taking an aspirin daily because of the blood issues. No additional information regarding the products. Weak after second vaccine: caller adds that this started at the same time, she was over the nausea and noticed this. It felt different than what it feels like with the flu. This is still going on, she did not think too much about it but it has persisted. Sometimes there is a little bit of shaking but that is intermittent. Caller states she can not put it into words. Bizarre shaking legs and arms after second vaccine: this goes with the weakness, she is continually weak but she has a shaky feeling that will come every now and then and is random. Large black bruise on left breast after second vaccine: Monday this started, 12APR2021 and it is still there but it is the same. It has not been sore like a bruise but it is black and large. The physician has seen it now and it is bizarre and scary. It is the left breast on the outside. Headache after second vaccine: started probably an hour after the vaccine, pretty quick. There were degrees to this headache because it was an actual migraine for a good 48 hours and even after the fever was gone it was terrible. It started out just a mild headache and then was very severe for a couple of days. Then, after that it was just there but not as severe. PVCs after second vaccine: caller adds that she went to the doctor yesterday 14APR2021 and she can tell every now and again that she is having these but there is nothing she can do about it. Caller adds this is everything new she can think of, but some of it is foggy, she thinks this is the main information. Brain fog after first and second vaccine: Caller then states, by the way, after both vaccines within 2 or 3 minutes of having them her head started feeling foggy and weird. Investigations: caller has not received any results yet. She did get an EKG, Chest XRAY, blood work, and the doctor also rattled off a bunch of things the doctor was going to check. These all were on 14Apr2021 and she is waiting on results. Caller confirms the physician told her she had PVCs while listening to caller's heart. Did any AE require a visit to: Physician office? 15Apr2021 she was in contact with her physician, and the whole week they were on the phone. Yesterday 14Apr2021 the physician wanted to see her. The doctor figured out something was going on with her heart so thankfully the doctor wanted to see her. It was discussed if caller should go to the ER but caller did everything she could not to go because that is the last place she wants to go. Emergency Room: no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of fever, vomiting, nausea was recovered, intermittent breathing issues, shaking legs and arms, weak, severe migraine, headache was not recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-04-27 weakness Patient reports receiving 2 Pfizer COVID vaccines. The first one was on 3/17/21 with lot # EN6207 wi... Read more
Patient reports receiving 2 Pfizer COVID vaccines. The first one was on 3/17/21 with lot # EN6207 with no adverse reactions. She received her second one on 4/5/21 with lot #EP7533. She reports she started "feeling bad" 4/6/21-4/11/21. She noticed left sided neck swelling on 4/11/21. She went to urgent care and was seen by an NP and was told to go to for a CT scan the next day since it was on a Sunday. Patient reports she went home and had further left sided neck swelling and difficulty breathing. She "couldn't catch her breath". EMS was called and she was transported per her request to Hospital. She had a 9 day hospital stay and was told she was having a severe reaction to the vaccine and that she had pneumonia with fluid in her lungs and fluid around her heart. She was treated with 2 antibiotics, IV fluids, and a diuretic. Patient had a follow up with her primary care on Monday 4/26/21 with NP and was told her heart and lungs sounded clear. She has a follow up appt scheduled with her lung doctor Dr on 5/24/21. Patient did not say why she has seen a lung doctor before but that she had been seeing this doctor prior to this adverse reaction. She was told in the hospital that it was not normal to be having this much swelling. Patient states she still feels weak and is still somewhat short of breath.
59 2021-04-27 muscle spasms, pain in extremity On 4/20/21 pt says she had swelling in left arm and 101 fever. She started cramping in her right ca... Read more
On 4/20/21 pt says she had swelling in left arm and 101 fever. She started cramping in her right calf. After a week of her leg hurting , on 4/27/21 she went to hospital. She had blood test and doppler. She was diagnosed w/ DVT of lower right extremity. She was prescribed Xarelto and to FU w/ PCP in a week.
59 2021-04-27 pain in extremity Patient has second Pfizer covid vaccine on 4/12/21, patient had chemotherapy treatment infuse throug... Read more
Patient has second Pfizer covid vaccine on 4/12/21, patient had chemotherapy treatment infuse through L portacath on 4/14/21. Patient called office with complaints of arm pain on 4/26/21. Ultrasound on 4/26 was read as: partial, nonocclusive thrombus within superficial left cephalic vein at the antecubital, midportion. Patient was initiated on oral anticoagulation therapy
59 2021-04-28 weakness, feeling cold pt says she developed a severe headache, nausea and was shivering. When she laid down she could fee... Read more
pt says she developed a severe headache, nausea and was shivering. When she laid down she could feel her heart beating. She took Tylenol. She woke up feeling like she had the flu. She was very fatigued. Her lack of motility symptoms have intensified. She had these symptoms for several days so went to her PCP which told her to monitor her symptoms. A week after taking the vax she started feeling very cold, had shivers, body aches, and developed a cough. She took Tylenol and went to bed. She woke up with a debilitating headache. She was weak and dizzy so took more Tylenol. She continued to be dizzy, felt fatigued and had brain fog. She called the vax nurse help line and was instructed to go to the ER. She went to the University. She had blood test, EKG, and Brain CT which were normal. She was dehydrated and was given IV fluids. She was monitored and sent for Covid and Sars testing which were normal. She still has shivers, chills, body aches and feels very tired and feels like this has interrupted her cognition.
59 2021-04-28 migraine Triggered 3-1/2 + week long migraine. Pain intensity at times 9/10. Neurologist put me on extended p... Read more
Triggered 3-1/2 + week long migraine. Pain intensity at times 9/10. Neurologist put me on extended prednisone taper to help break cycle.
59 2021-04-28 pain in extremity, breast pain blood clot under her eye; bright red bruise in the corner of the eye to the middle of the eye undern... Read more
blood clot under her eye; bright red bruise in the corner of the eye to the middle of the eye underneath; feeling crummy; she was down; headaches; couldn't move; arm hurt all the way below her arm pit into her breast; arm hurt all the way below her arm pit into her breast; arm hurt all the way below her arm pit into her breast; got very sick; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 08:30 (at the age of 59years) as single dose for Covid-19 immunization. Medical history included ongoing rheumatoid arthritis and osteoarthritis (not bad enough that she takes treatment, but she is diagnosed; she was diagnosed way back in 2006). Concomitant products: patient stated she takes some medications (not further specified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she had her first dose of the Pfizer Covid-19 vaccine on 05Apr2021 and got very sick. She was down for two days and after day 10 (as reported) she has a blood clot under her eye. She would like to know what would happen if does not get a second dose. She consulted if there is any talk on whether or not people should receive an additional dose of the Pfizer Covid-19 vaccine next year. The patient further reported that on 06Apr2021 she woke up feeling crummy right away and a couple of hours into that day she couldn't lift her arm, literally couldn't lift arm for 6 inches and stated it went on for 2 days. She further stated that her arm hurt all the way below her arm pit into her breast. She stated that it all ended on 08Apr2021 and she went back to work on 08Apr2021. The patient added that she was down for two days, had headaches, and stated she never knew what people meant when they said they got hit by train. She doesn't believe she had a fever and couldn't move. The patient further stated that she got pretty darn sick and this morning 14Apr2021, she woke up with a blood clot under her eye. She is an esthetician and is pretty good with skin. She stated that she doesn't know how she could get this overnight unless she injured herself in her sleep, but she is a light sleeper. She does not know if it is a clot. She also stated that she called a medical esthetician who told her to take a baby aspirin and cold compress. The patient clarified that she didn't feel so good and today she feels better. She doesn't know that it is a blood clot, it is not raised and not hard, it looks like she has a bright red bruise in the corner of the eye to the middle of the eye underneath, not in the eye. She wants to make it clear she doesn't know if it is a blood clot. She feels like if she hurt herself, that would be the reason, but it would be painful, and it is not. She added that the bruise is about the same. Therapeutic measures were taken as a result of the events (except for feeling down and couldn't move). The outcome of events thrombosis and contusion was not recovered; the outcome of other events was recovered on 08Apr2021.
59 2021-04-28 pain in extremity, tenderness a few hours later she was fatigue, the next day there was sore muscles and the arm was sore, the sor... Read more
a few hours later she was fatigue, the next day there was sore muscles and the arm was sore, the soreness of muscles were gone but the arm was more swollen. There is no pain unless pressing directly on it but there is swelling.
59 2021-04-28 tremor, seizure Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side;... Read more
Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side; she was about to faint; seizure; Diarrhea; chills; head hurting; eyes hurting; Muscle soreness; joint pain; Nausea; temperature of 99.3; This is a spontaneous report from a contactable consumer (daughter of patient) and another consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 16:21 (Lot Number: EW0164; Expiration Date: Aug2021) at vaccination age of 59 years old as single dose for covid-19 immunisation. Medical history included vertigo, antacid therapy. Concomitant medication included esomeprazole magnesium (NEXIUM 24HR) taken for antacid therapy from an unspecified start date and ongoing. No additional vaccines administered on same date of the Pfizer Suspect. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EP7533), on 23Mar2021 at 17:38 PM at age of 59 years old in the right arm as single dose for covid-19 immunisation and only had a little bit of muscle soreness on her right arm on 23Mar2021 after the first dose and it went away the day after (24Mar2021). The patient took Tetanus shot about two weeks before the first dose of the Pfizer COVID 19 vaccine. Then received the second dose on 13Apr2021 16:21PM in the left arm. After the second dose she had chills; her head was hurting; her eyes were hurting; she had muscle soreness; she had joint pain all yesterday 14Apr2021. Then this morning 15Apr2021, after taking a Tylenol and getting a shower she felt dizzy like she was about to faint. Her mother had vertigo but this was not like her usual vertigo. Her mother sat on the bed and started to have what looked like a seizure with twitching and shaking; then she lost consciousness. Her mother's eyes were open and they saw her mother's eyes twisted, went to one side, and she fell back on the bed. They called at 05:30 AM and the ambulance arrived quickly but by the time they arrived she had regained consciousness. They recommended she follow up with HCP. They called the doctor who advised her to rest, and make an appointment to see the doctor tomorrow. Reporter clarified her mother had the chills from 10:00 AM today (15Apr2021) and had them day with a lot of headache, eyes hurting goes along with the headache, and she had a temperature of 99.3. The chills and temperature resolved last night then the eyes hurting ended this morning (15Apr2021) with the headache. All of the other symptoms resolved yesterday (14Apr2021). She also had nausea that started yesterday (14Apr2021) and she started to have diarrhea once today (15Apr2021)and felt like it had stopped. The nausea was coming and going from time to time. The events did not require a visit to emergency room or physician office. The outcome of events chills, muscle soreness, joint pain, temperature of 99.3 was recovered on 14Apr2021. The outcome of events Lost consciousness, head hurting, eyes hurting, felt dizzy, twitching and shaking, eyes went to one side, Diarrhea was recovered on 15Apr2021. The outcome of event seizure, she was about to faint was unknown. The outcome of event nausea was recovering.
59 2021-04-28 tremor Slight fever, severe chills and shaking to the bone where whole body tightens. Took 2 alka-seltzer p... Read more
Slight fever, severe chills and shaking to the bone where whole body tightens. Took 2 alka-seltzer plus cold and flu evervescent tablets. Waiting to see if works.
59 2021-04-28 tremor Slight fever, severe chills with shakes That tighten the whole body. Talk 2 alka-sheltzer plus cold ... Read more
Slight fever, severe chills with shakes That tighten the whole body. Talk 2 alka-sheltzer plus cold and flu effervescent tablets. Waiting on results.
59 2021-04-29 tingling, burning sensation Just under 48 hours after the vaccine on 4/10/2021, I experienced a large swelling on either side of... Read more
Just under 48 hours after the vaccine on 4/10/2021, I experienced a large swelling on either side of my neck, up and down the neck. I assume it was my lymph nodes. I felt as if someone was pushing my Adam's apple. Unpleasant and scary as I though it might get worse and I would choke. This lasted most of the day Saturday. The same swelling and pressure in my throat occurred after the second Pfizer shot on 4/29/2021 (Lot Number: EW0153 ; 7/21/2021). This time it happened more quickly. Five hours after I received the shot. (Vaccine received at 11:30 am). The pressure in my throat lasted throughout the afternoon. I also felt burning and tingling at the site of the FIRST vaccine at this time.
59 2021-04-29 seizure like phenomena Dizzy when ambulating to bathroom, fell, hit head, had subsequent seizure-like activity
59 2021-04-30 weakness Chills. Body aches no energy tired. Head ache
59 2021-04-30 pain in extremity, muscle spasms Patient received second dose of Pfizer vaccine 04/01/2021 and presented to office 04/19/2021 with re... Read more
Patient received second dose of Pfizer vaccine 04/01/2021 and presented to office 04/19/2021 with report of left leg pain. Patient seen for repeat evaluation of leg pain after negative labs on 04/26/2021. Patient reported left leg popliteal pain as well as chronic leg cramps.
59 2021-04-30 pain in extremity swelling all on the site; a little bit of soreness/her arm was sore; This is a spontaneous report fr... Read more
swelling all on the site; a little bit of soreness/her arm was sore; This is a spontaneous report from a contactable consumer or other non-health care professional. A 60-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8727) via an unspecified route of administration in right upper arm on 18Mar2021 around 15:00 PM as single dose for COVID-19 immunization (at 59 years old). Patient received the second dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration in right upper arm on 08Apr2021 as single dose for COVID-19 immunization. Medical history included ongoing COPD; Unsure of diagnosis date but it was maybe 10 years ago, ongoing Chronic kidney disease stage 3; Unsure of diagnosis date but probably more than 20 years ago and it is stable. They check it every 3 months and it is stable. Historical vaccine included flu shots and pneumonia shots; she has had flu shots and pneumonia shots and has never had any reaction to anything before. Patient mentioned that she is on medication (unspecified) but she has been on them all her life there is just about nothing new that was taken at all. On 18Mar2021, patient experienced swelling all on the site and a little bit of soreness/her arm was sore. Outcome of the events was recovered on 19Mar2021. Follow-up (20Apr2021): This is a follow up spontaneous report received from a contactable consumer reported that no new AE was reported. No follow-up attempts are needed. No further information is expected.
59 2021-04-30 pain in extremity Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure;... Read more
Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure; Severe chills; Strange redness across her shoulders; Arm hurt after shot; Pressure in head; Very loose stools; Nausea; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 13:30 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation (Age at vaccination: 59 years) . Medical history included liver disorder , hypersensitivity, hepatitis C from , osteopetrosis , arthropod sting allergy , drug hypersensitivity , gluten sensitivity (She is borderline celiac, and she will get really bad gastro problems for 2 or 3 days after digesting gluten) , penicillin hypersensitivity (She has itching, rash, nausea) , peanuts allergy (Keeps an EPI pen for this). Concomitant medications included d-ribose, polypeptide (TRANSFER FACTOR [D-RIBOSE;POLYPEPTIDE]) taken for hepatitis C from 2003 to 03Apr2021; ascorbic acid (VITAMIN C ACID) taken for an unspecified indication from an unspecified start date to 03Apr2021; vitamin D3 (VITAMIN D3) taken for osteopetrosis from an unspecified start date to Apr2021; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient experienced high bp/pressure in head and high blood pressure on 05Apr2021 with outcome of unknown , fatigue on an unspecified date with outcome of unknown , severe chills on 05Apr2021 with outcome of unknown , low body temperature on an unspecified date with outcome of unknown , strange redness across her shoulders on 05Apr2021 with outcome of recovered , arm hurt after shot on 05Apr2021 with outcome of unknown , pressure in head on 05Apr2021 with outcome of unknown , very loose stools on 05Apr2021 with outcome of unknown , nausea on 05Apr2021 with outcome of unknown , brain fog on 06Apr2021 with outcome of not recovered , anxiety on an unspecified date with outcome of unknown. Hypertension was considered an Important Medical Event. The remaining events were non serious. The patient underwent lab tests and procedures which included blood pressure increased: 179/98, 170/97 on unknown date , blood pressure measurement: 152/87 on 06Apr2021 , body temperature decreased: low No follow-up attempts are needed. No further information is expected.
59 2021-04-30 pain in extremity Felt fine all day after shot. Middle of the night I woke up and felt like someone had punched me in ... Read more
Felt fine all day after shot. Middle of the night I woke up and felt like someone had punched me in the arm and I had chills/aches. Went to work next day but only lasted two hours. Lots of aches, chills. Second day was okay 80%, Third day was okay.
59 2021-04-30 pain in extremity acute lymphatic response/severe pain in lymph nodes, the ones around her ovaries/severe pain like cy... Read more
acute lymphatic response/severe pain in lymph nodes, the ones around her ovaries/severe pain like cysts except both sides were hurting; had trouble catching breath with the pain; arm pain; brain fog/head started feeling foggy and weird; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 16:00 (Lot Number: EN5318, Expiry date: 31May2021) on left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Historical Vaccine included flu shots. The patient stated her physician told her she had an acute lymphatic response. She added there was something about 3 am (18Mar2021) because she woke up at 3 am and had severe pain in some of her lymph nodes. In particular, the ones around her ovaries. She added that she was old and her ovaries had not worked in a long time. She had severe pain like cysts except both sides were hurting. She also had trouble catching breath with the pain. This lasted 45 minutes and subsided. The next morning 18Mar2021, when she got up some of her lymph nodes were very panful and there was one even that was a node visible down her throat almost at the base of her neck in the center. She could see it sticking out, it was crazy. It went down in about three days. The pain and the weirdness in all of her other lymph's was about 3 or 4 days. It was an odd response and people told her it was just her body acting like a young person and was going to work. This was the first issue she had with the vaccines. The patient also experienced brain fog after first vaccine on 17Mar2021: within 2 or 3 minutes of having them her head started feeling foggy and weird. It was after the first vaccine, she thought it was psychological but it did not go away and it was not psychological. It was like a weird foggy and like taking sinus medication, no additional details. When it happened with the first vaccine, it did not concern her as much as the first one. It went away after the first vaccine probably late that evening (17Mar2021), around 10:30 pm right when her arm started to hurt. She did not have arm pain that was severe. She added maybe it lasted a day. The next day it hurt but it was not anything bad, it just hurt to touch it and to lift it hurt for a day. Maybe this was for 36-40 hours before the pain went out. The outcome of event "trouble catching breath with the pain" was resolved on 18Mar2021 03:45, outcome of event "brain fog/head started feeling foggy and weird" was resolved on 17Mar2021, outcome of other events were resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
59 2021-04-30 pain in extremity they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving he... Read more
they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving her muscles; having a hard time walking moving my muscles/Every muscle and joint ached severely; having a hard time walking moving my muscles/Every muscle and joint ached severely; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; I have had fluttering and my heart feels like it is jumping in my chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 08:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypothyroidism, fibromyalgia, Type 2 diabetes. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included atorvastatin, duloxetine, glimepiride, and levothyroxine. The patient had not received other vaccine in four weeks. The patient previously received pregabalin (LYRICA) and had allergies. On 02Apr2021 12:00, the patient had Redness and swelling in left arm for 2 days with pain. 2 days after shot (04Apr2021) she was having a hard time walking moving her muscles. Every muscle and joint ached severely nothing helped the pain. Now she was 13 days past the shot with muscle pain. She went to doctor yesterday (14Apr2021) and they did an EKG and it was abnormal. She had 2 extra heartbeats in Apr2021. Since shot she had had fluttering and her heart felt like it was jumping in her chest. The patient had Blood work in Apr2021. The outcome of all events was not resolved. Information on the lot/batch number has been requested.
59 2021-05-01 weakness, feeling cold I had a headache for two days, Tylenol helped. I felt cold and or feverish most of the time. I was v... Read more
I had a headache for two days, Tylenol helped. I felt cold and or feverish most of the time. I was very weak and tired. My nose ran a little.
59 2021-05-01 pain in extremity I have had COVID Arm for five weeks and ibuprofen is not giving me any relief for the pain in my arm... Read more
I have had COVID Arm for five weeks and ibuprofen is not giving me any relief for the pain in my arm, shoulder, neck and armpit
59 2021-05-02 weakness Severe flu like symptoms, including low grade fever lasting 3 days. Severe headache, dizzy, weak, un... Read more
Severe flu like symptoms, including low grade fever lasting 3 days. Severe headache, dizzy, weak, unable to eat for 36 hours.
59 2021-05-02 discomfort Approximately 2 minutes after the injection my heart started beating very rapidly. My palms started ... Read more
Approximately 2 minutes after the injection my heart started beating very rapidly. My palms started to sweat and I felt very uncomfortable. After 15 minutes I told one the staff members that I was not feeling good. She took my blood pressure and it was 168/86. After 15 minutes she took it again and it was 169/95. The last reading after another 15 minutes was 168/104. I rested for a while, felt better and went home. Once I was home I felt nausea and my hands were still sweating. I had a headache and my blood pressure was still high.
59 2021-05-03 weakness Pt brought to med obs #1 via stretcher after experiencing tunnel vision/blurred vision, warmth, weak... Read more
Pt brought to med obs #1 via stretcher after experiencing tunnel vision/blurred vision, warmth, weakness, dizziness, and full syncopal episode with LOC. Placed on floor with BLE prior to stretcher arrival. Brought to med obs #1 with staff. Alert to voice, appears lethargic, but able to answer questions appropriately. Pt reporting she "feels exhausted." Denies history of syncope/LOC. Continuous VS monitoring in place. No s/s of distress noted. Improvement of symptoms noted, alert to voice, eyes opening spontaneously. Pt instructed to call daughter for ride home. Given water, declined snack. Orthostatic VS obtained. VSS. Symptoms completely resolved. Daughter arrived to collect pt. Pt and daughter escorted to exit by staff via wheelchair. VS are as follows: 1155: BP 151/97, HR 90, RR 20, O2 sat 98% on RA 1200: BP 137/88, HR 79, RR 20, O2 sat 96% on RA 1205: BP 137/88, HR 78, RR 20, O2 sat 97% on RA 1210: BP 130/82, HR 80, RR 18, O2 sat 99% on RA 1215 (lying): BP 142/90, HR 74, RR 18, O2 sat 98% on RA 1225 (sitting): BP 149/94, HR 73, RR 18, O2 sat 98% on RA 1226 (standing): BP 141/89, HR 72, RR 17, O2 sat 99% on RA 1234: BP 148/88, HR 74, RR 18, O2 sat 98% on RA
59 2021-05-03 weakness On April 15, I had aches and pains and was very tired. On April 16th, I developed a tennis ball-size... Read more
On April 15, I had aches and pains and was very tired. On April 16th, I developed a tennis ball-sized lump under the arm I received the shot in. It is still there to date but has shrunk to the size of a golf ball. On April 30th, I developed a sore throat. May 1st, I threw up several times. I stayed in bed feeling weak with a low-grade fever on and off. I also developed a deep productive cough followed by wheezing on my exhale. It is now May 4th. I am still coughing and have a lot of mucous production. Fever comes and goes. I had a telephone "visit" with my PCP on May 3rd because both his office and urgent care would not allow me to come in person with possible COVID symptoms. My PCP prescribed an antibiotic, an inhaler and a cough medicine.
59 2021-05-03 pain in extremity EXTREME PAIN IN ARM PIT AND INSIDE UPPER ARM OF ARM THE VACCINE WAS ADMINISTERED THE DAY AFTER. ON 2... Read more
EXTREME PAIN IN ARM PIT AND INSIDE UPPER ARM OF ARM THE VACCINE WAS ADMINISTERED THE DAY AFTER. ON 2ND DAY AFTER THE PAIN WAS CONSTANT WITH BURNING PAIN IF TOUCHED AT THE INSIDE UPPER ARM. ON 3RD DAY AFTER DULL ACHE WITH BURNING PAIN IF TOUCHED. ON 4TH DAY AFTER DULL ACHE WITH TIGHT FEELING IN ARMPIT AND INSIDE UPPER ARM AND STILL BURNING PAIN IF TOUCHED OR PRESSED ON. ON DAY I TOOK OTC TYLENOL DAY 2 TOOK TYLENOL, TYLENOL PM AND ICED AREA DAY 3 TOOK ALEVE AND HEATING PAD ON AREA DAY 4 TOOK ALEVE
59 2021-05-03 tingling Ongoing tingling sensation across face (especially on forehead, below eyes around the noise, and che... Read more
Ongoing tingling sensation across face (especially on forehead, below eyes around the noise, and cheeks). Sensitivity when blinking eyes. Took Claritin and Zrytek for two weeks attempting to counteract the reaction. Went to my Primary Physician on April 19. He prescribed Methylprednisolone 4MG Dospak. Started to feel some relief, took second vaccine and symptoms acceleted again. Finished the Methylprednisolone and still struggling with this reaction. After feeling sensations moving from my face to my arms and legs, went to emergency room.
59 2021-05-03 speech disorder pt received vaccine at 1008. at approx 1030 she began to feel her tongue tingle and swollen. worsene... Read more
pt received vaccine at 1008. at approx 1030 she began to feel her tongue tingle and swollen. worsened by 11:00 and reported it to us. BP, HR, pulse ox normal. allowed to rest, drinking water. checked back ~ 1115 - BP and HR elevated to 167/94 and 105. no SOB or wheezing but tongue becoming thicker, harder to swallow and talk. pt escorted to ER. in ER, she was given IV pepcid, bendaryl and solumedrol. sxs improved and she was dc'd home w/ prednisone. her breathing was never compromised, no stridor or tripod positioning while in ER. vitals remained stable.
59 2021-05-04 burning sensation, pain in extremity Contact dermatitis to face from chemicals from cleaning; sore arm; hives; burning; This is a spontan... Read more
Contact dermatitis to face from chemicals from cleaning; sore arm; hives; burning; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Deltoid Right on 16Apr2021 08:30 (Batch/Lot Number: ER8731) at the age of 59-years-old as single dose for covid-19 immunization. Medical history included heart disease diagnosed in 2003 and She had a heart attack. Family medical history: high blood pressure and heart disease. Mother had Diabetes. The patient's concomitant medications were not reported. The patient previously got the 1st dose of BNT162B2 on 24Mar2021 Lot ER8727, it was also injected on right arm in the muscle for covid-19 immunization. She got the second shot on Friday (on 16Apr2021) and all had was sore arm. There were no side effects. On the second day on 17Apr2021, or actually the night, she was cleaning and got contact dermatitis on her face. She was not wearing gloves and touched her face. She got contact dermatitis to face from the chemical. She went to an Urgent Care and was prescribed Prednisone 10mg. She took 5 of them on Saturday, 4 on Sunday and 3 today. Now it was gone, so she was not going to finish out day 2 and day 1. Her doctor told her not to. No emergency Room (ER) or physician's office required. She would like to know if taking the Prednisone will effect the efficacy of the vaccine. It was not from the vaccine. It was from the chemical. She got hives and burning on an unknown date in Apr2021. The outcome of the event contact dermatitis to face was recovering, and the outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: The event dermatitis contact is attributed to chemicals from cleaning product and assessed unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
59 2021-05-04 discomfort Patient initially felt discomfort throughout her body and was unease. At this time, two Diphenhydram... Read more
Patient initially felt discomfort throughout her body and was unease. At this time, two Diphenhydramine 25mg tablets were given to the patient orally. Then five minutes later, patient had slight syncope. Then three minutes later, patient complained of discomfort in the throat area. Then 2 minutes later patient expressed pain and tightness in the throat area and was disoriented. At this point, one Epinephrine injection of 0.3mg was given intramuscularly in upper outer thigh area and 911 was called. Patient was monitored closely until Emergency Paramedics arrived.
59 2021-05-04 muscle spasms hesitant and nervous to get the second dose; felt like paranoid; hyperventilating; Heart beating fas... Read more
hesitant and nervous to get the second dose; felt like paranoid; hyperventilating; Heart beating fast for about 5 -10 minutes; Muscle spasms; Her allergies were trying to activate; This is a spontaneous report from a contactable consumer (patient). This 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 02Apr2021 11:56 (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included two weeks prior to receiving the Covid vaccine she was on antibiotics for diverticulitis from Mar2021 for 10 days. Two weeks prior to receiving the Covid vaccine she was on antibiotics for diverticulitis for 10 days. She wonders if she should have waited longer. Concomitant medications included ongoing Zinc from Mar2020 at 50mg daily to keep immune system fully activated, she thinks she needs more, ongoing Vitamin D3 from Mar2020 at 5,000IU/125mcg every other day to keep immune system fully activated, ongoing bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lact, bacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) from 2020 at 10,000,000,000 viral daily to keep good bacteria in her stomach to keep immunity good, and ongoing Multivitamin from Mar2020 at every other day to keep immune system fully activated. She received the first dose of the Covid-19 vaccine on 02Apr2021. She was fine until that night, early in the morning. 03Apr2021 at 2:00 am she was paranoid and was hearing a voice. She felt like she was hyperventilating a little bit on 03Apr2021. That lasted for 10 minutes and went away. The next morning on 03Apr2021 her heart was beating fast. That lasted for 5-10 minutes. She felt like she was having muscle spasms on 03Apr2021 that lasted for 5 minutes. She felt like her allergies were trying to activate on 03Apr2021. She took an allergy pill and it worked for her allergies to keep them from acting up. After that she didn't experience anything else. She was hesitant and nervous to get the second dose. The second dose is scheduled 23Apr2021. She was taking Metronidazole 500mg twice daily for 10 days. No emergency room and physician office. Outcome of the event paranoid and heard a voice, hyperventilating, heart was beating fast, Muscle spasms was recovered on 03Apr2021. Outcome of the event allergies were trying to activate was recovered on 04Apr2021. Outcome of other event was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-05-04 pain in extremity a staff member hit her in her right arm, right arm had been hurting ever since then; This is a spont... Read more
a staff member hit her in her right arm, right arm had been hurting ever since then; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in right arm on 14Apr2021 13:00 (Lot Number: EP7534, Expiration date: Jul2021) as single dose for covid-19 immunisation. Medical history included lupus from 2019. Patient was diagnosed with lupus of the skin and bones in 2019. She said she got infusions for the lupus in her left arm. Concomitant medication(s) was not reported. Patient previously received BNT162B2 (Lot Number: EN6205, Expiration Date: Jun2021) first dose administered in right arm on 26Mar2021 for covid-19 immunisation. On14Apr2021, patient went to work afterwards, and a staff member hit her in her (right) arm (around 6:00PM). She said her right arm had been hurting ever since then. She said she took Tylenol and put alcohol on her arm, but she was still having pain (clarifying her right arm hurts when she tried to lift it). Patient took a Tylenol (Lot Number: 30035519, Expiration Date: Jul2022) 325mg tablet that was dispensed in a little packet from her job (mental hospital). Stated she did not see a NDC Number, providing number SDC002. Patient stated when got home from work, she applied Alcohol to her right arm. She stated she was not sure if the first character in the Alcohol 50% Lot Number was an "8" or "0". Reported she was right-handed and had got both COVID-19 Vaccine doses in her right arm. She said she didn't use her left arm because she got infusions in her left arm for her lupus of the skin and bone. Patient stated she had no problem with the COVID-19 Vaccine, until she was hit in the arm she received the COVID-19 Vaccine in. A sample of the product was available to be returned, if requested. The event outcome was not recovered. No follow-up attempts are possible. No further information is expected
59 2021-05-05 hot flush Hot flash.
59 2021-05-05 numbness numbness of left thigh. comes on with pressure. occurs when sitting or laying down.
59 2021-05-05 numbness Reaction: Anaphylaxis, numbness in the nose area and heaviness in the chest Severity: High
59 2021-05-05 muscle spasms Stiffening of muscles as though in a workout at the gym on day of the vaccine, day two all muscle gr... Read more
Stiffening of muscles as though in a workout at the gym on day of the vaccine, day two all muscle groups felt as if they had had severe cramps overnight and moving any part of my body was very painful. Persisted for two days. Complete exhaustion and lots of pain.
59 2021-05-05 pain in extremity body ache, back pain, arm pain, fever, chills
59 2021-05-05 tremor, weakness Beginning 9 hours after injection, I experienced severe chills and shaking for approximately two hou... Read more
Beginning 9 hours after injection, I experienced severe chills and shaking for approximately two hours. Nausea, severe body aches, loss of appetite, and weakness followed. Fever peaked at 101.8. These symptoms started to diminish about 33 hours after injection. Complete recovery happened approximately 42 hours after injection. Only fluids, clear soup, and popsicles were eaten from 33-42 hours. Nausea prevented taking anything other than fluids before that.
59 2021-05-05 tremor Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Hypertension-Medium, S... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient experienced throat tightness and dry mouth. Benadryl administered, then Epipen 0.3mg. Blood pressure was high, paramedics came to check her out. BP went back to normal and patient was sent home
59 2021-05-06 slurring, mild one side paralysis Pt is a 59 YOF who received her first COVID-19 Pfizer vaccination on 4/16/21. She has PMH significan... Read more
Pt is a 59 YOF who received her first COVID-19 Pfizer vaccination on 4/16/21. She has PMH significant for diabetes mellitus type II, hypertension, COPD. Almost immediately post vaccine, patient started exhibiting signs of slurred speech and right side weakness. Patient started improving when being moved to triage – however after a few minutes, slurred speech and confusion returned. 911 called and patient transported to ED. On admission neurology consulted and initial CT head negative. Patient received IV tPA and MRI brain was obtained which showed left medial pontine infarct. Diagnosis: Left pontine stroke. NIH 4 on admission and discharge. No history of TIA nor stroke. Unclear if stroke is related to vaccine...
59 2021-05-06 seizure Patient had a seizure about 5 minutes after vaccination was administered. Patient has a history of s... Read more
Patient had a seizure about 5 minutes after vaccination was administered. Patient has a history of seizure according to the husband. We were not sure if the seizure started because of the vaccine or because of nervousness before getting the vaccination.
59 2021-05-07 face paralysis This 59 year old female received the Pfizer Covid shot on 1/26/21 and went to the ED on 2/4/21 ... Read more
This 59 year old female received the Pfizer Covid shot on 1/26/21 and went to the ED on 2/4/21 and was admitted on 2/4/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) I63.9 - Cerebral infarction, unspecified R29.810 - Facial weakness
59 2021-05-07 feeling cold, feeling hot little heart palpitations; felt really warm; felt like she was on fire; Nauseous; she was white as a... Read more
little heart palpitations; felt really warm; felt like she was on fire; Nauseous; she was white as a ghost; felt cold; Dizzy; bruised her tailbone; Passed out; from when she fell she has a knot on the back of her head, and her back has a kink; from when she fell she has a knot on the back of her head, and her back has a kink; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm on 22Apr2021 17:36 (Lot Number: EW0161) (at age 59 years old) as single dose for covid-19 immunisation. Medical history included diabetic from an unknown date and unknown if ongoing diagnosed in 2001-2002. The patient's concomitant medications were not reported. She did not get any other vaccinations yesterday or in the last four weeks. She says she has started no other new meds recently. The patient stated she got her first dose on 22Apr2021 and was perfectly fine, she didn't feel anything. She says when she went to bed a few hours later, she felt really really warm like she was sunburnt or something. She says she slept, then woke up around midnight and got up and thought maybe she had to go to the bathroom. She says she felt nauseous and thought she was going to be sick so she went back to the bathroom and she was white as a ghost, and felt cold and dizzy. She says she was feeling like she was gonna pass out, so she thought her sugar levels had dropped really low, so she went downstairs to check them then woke up on the floor, she had passed out. She says she came to, and checked her sugar and it was normal, 110, so she is assuming she passed out due to the shot. She says her first dose was injected around 17:36, and it was a few hours later when she went to bed around 09:00-9:30PM and got into bed when she kind of felt like she was on fire. She says she did no treatment; she went to sleep. She says from when she fell she has a knot on the back of her head, and her back has a kink in it. She says she is sure she has also bruised her tailbone. As of 23Apr2021, she doesn't feel warm or anything now, she just has little heart palpitations that is all, and those have stayed about the same. Outcome of the events was unknown.
59 2021-05-07 pain in extremity Tiredness; brain fog; headache; Day 1 Sore arm; This is a spontaneous report from a non-contactable ... Read more
Tiredness; brain fog; headache; Day 1 Sore arm; This is a spontaneous report from a non-contactable Other Health Professional, the patient. A 59-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EK5730), via an unspecified route of administration as a single dose on 30Dec2020 for COVID-19 immunisation. The patient medical history was not reported. No allergies to medications, food, or other products reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium/magnesium/ vitamin d nos (CAL MAG), calcium carbonate/colecalciferol/phytomenadione (Vit D+K), fish oil (OMEGA 3) and multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020, the patient experienced sore arm on day 1 of vaccination and on 31Dec2020 experienced tiredness, brain fog and headache. No treatment was received for the events. The outcome of the events were recovered on an unknown date. No follow-up attempts are possible. No further information is expected.
59 2021-05-07 pain in extremity pain in that arm when lifting it/The soreness is in the right arm; has pain in that arm when lifting... Read more
pain in that arm when lifting it/The soreness is in the right arm; has pain in that arm when lifting it, at the injection site; This is a spontaneous report from a Pfizer Sponsored Program. A contactable Nurse (patient) reported that a 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EH9899), via an unspecified route of administration at right arm as a single dose on 05Jan2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received influenza vaccine (FLU VACCINE VII, NDC, Lot, and expiry unknown) in Oct2020 and it encapsulated and she still has a small bump on her left arm, this is why she is not sure what arm to use. No additional Vaccines Administered on same date of the Pfizer suspect. The patient reporting on the COVID vaccine and who explains she got the first shot 3 weeks ago. She is schedule to have second dose this afternoon but has pain in that arm when lifting it, at the injection site on an unknown date in Jan2021. Patient wants to know what to do. Patient wanted to know is it ok to get the other shot, should she have it in the same area or on the other side, and is this normal this long after the first shot. The soreness is in the right arm on 05Jan2021. It was explained the arm got a little worse the next day then calm down and has stayed the same since that time. Treatment: She has been alternating hot and cold on the injection site. The outcome of pain in arm was not recovered and vaccination site pain was unknown. Event pain in that arm when lifting it was reported as Related. Follow-up attempts are completed. No further information is expected.
59 2021-05-07 tension headache Passed out; Pressure in her head; Major headache; Fatigue/ tiredness; Stress/fatigue headache; This ... Read more
Passed out; Pressure in her head; Major headache; Fatigue/ tiredness; Stress/fatigue headache; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration in left arm on 12Apr2021 at 09:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation and asthmatic. The patient's medical history included rheumatoid arthritis (diagnosed three months ago), sleep disorder, blood pressure, blood pressure increased, PTSD (post-traumatic stress disorder). Patient's medical history (including any illness at time of vaccination) was none. Concomitant medications included trazodone (Strength: 25 mg) orally taking for years at 25 mg, once a day for sleep disorder, losartan (Strength: 25 mg) orally taking for 4 years at 25 mg, once a day for blood pressure, acetylsalicylic acid (ASPIRIN) orally taking for 4 years 81 mg, once a day for blood pressure increased, hydroxychloroquine (Strength: 200mg) orally taking for two months at 200 mg, once a day for rheumatoid arthritis, leflunomide (Strength: 10 mg) orally taking for two months at 10 mg, once a day, sertraline orally taking for 4 years at 50 mg, once a day for PTSD (post-traumatic stress disorder); All ongoing. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206, NDC number: Unknown, Expiration date: Unknown), on 22Mar2021 at 15:30 as a single dose in left arm for COVID-19 Immunization and asthmatic. Family history was none. Prior vaccinations (within 4 weeks) was none. No additional vaccines administered on same date of the Pfizer suspect. On 14Apr2021 she reports developing a headache that has been ongoing since then, 14-16 days total. She also reports fatigue. She has been seen by doctors and had CT scans and bloodwork, the doctors think it was a stress/fatigue headache. Caller indicated she didn't think the symptoms were vaccine related but wants to rule everything out. Enquired what information do we have for duration of headache after vaccination. Caller indicated she had already spoken to a nurse with safety. Caller was a 59-year-old female reporting a headache that started 2 days after her second dose of the Pfizer COVID-19 vaccine, with symptoms that have been ongoing for 14-16 days. Response: Provided information from fact sheet that 55.1% of patients reported headache in the clinical trials, and that data was coming from the 7 days after either dose. Enquired how long side effects last. Which states adverse events typically start 1-2 days after vaccination and resolve shortly thereafter; Also spoke from CDC data which indicates adverse events might be more intense after the second dose. Referred back to healthcare professional for additional assessment and treatment. Consumer calling regarding the Pfizer COVID-19 vaccine. Reports she got the second shot 12Apr2021 and a couple of days later she got pressure in her head that has turned into a major headache. States and it has been a major headache. Reports she has been to the emergency room and her primary care doctor. Adds she had a CT scan, and bloodwork till she looks like a pin cushion, and everything was coming back fine. Adds she was tired all the time and could not get rid of the headache. Her question; Mentions she was looking at the side effects and saw tiredness and headaches a couple of days after; but enquired have we had any complaints about them lasting so long. Clarified she received the second dose of the Pfizer COVID-19 vaccine on 12Apr2021 at 09:30 AM in the left arm. A couple of day later the headache started; and the tiredness started at the same time. Tiredness was reported as worsened. She got the shot at PRIVACY. Adds she has missed two weeks of work and she could sleep 24 hours a day if the headache would let her. Adds she was 60 years old and takes a lot of medication; she tries not. Primary/prescriber: States the rank was major; she thinks her doctor was on maternity leave; Product: Pfizer COVID-19 vaccine; treatment first dose of the vaccine 22Mar2021 at 15:30 PM in the left arm. Lot EN6206; provides lot number for both doses from vaccination card but does not see NDC, expiration date or dose. This past Sunday the headache got so bad that she passed out in her living room and her 72-year-old husband called 911. She was taken to the (PRIVACY) Hospital and they did the CT scan and the blood work that was normal. She went home and tried to go to work on Monday and that only lasted 3 hours. No investigation assessment. No relevant test. The adverse events require a visit to emergency room but not admitted to the hospital and visit to physician office as she saw a doctor at the base on Monday, she had doctor's excuse to be off on Monday and Tuesday, so she called and got a walk-in appointment for Thursday. They did more blood work, and it came out great. The patient underwent lab test and procedure which included blood work: Normal, CT scan: Normal on an unspecified date. The outcome of the event passed out was recovered on an unspecified date in 2021, unknown for the event pressure in her head and not recovered for the other events. No follow-up attempts are needed. No further information is expected. Lot number obtained.
59 2021-05-08 muscle spasms Abnormal uterine bleeding and diarrhea, 5/7 to 5/9
59 2021-05-09 weakness complaint of weakness, FATIGUE, NAUSEA, DIARRHEA, HEADACHE, NO APPETITE
59 2021-05-09 burning sensation Day of shot within 1 hour Felt like my arm was dislocated for several days. Still feeling discomfort... Read more
Day of shot within 1 hour Felt like my arm was dislocated for several days. Still feeling discomfort. Day 3 Extreme burning in lower jaw with pain also similar to toothache and all teeth and lower jaw. Eventually extended throughout my neck and lower part of my head. Inhaling felt like stabbing in lower neck and a three and four.
59 2021-05-09 pain in extremity I was hospitalized for bilateral pulmonary embolism 4/18/2021 at hospital. I think I had symptoms fo... Read more
I was hospitalized for bilateral pulmonary embolism 4/18/2021 at hospital. I think I had symptoms for over 3 weeks prior to hospitalization. I was rapid COVID tested on 3/26/2021 the nurse at CVS asked why my blood oxygen was low. I did not know but had me pant and move my fingers and it went up to 96. I also remember severe leg pain on a drive 3/25/21. I noticed shortness of breath 4/5/21 and fast pulse but didnot go to hospital until 4/18/21. I previously had a PE 7/2009 and also had it for ~2 weeks before going to hospital. I was not on blood thinner since 2015. The doctors at the hospital and primary care doctor did not seem to think the PE was vaccine related but they also do not believe I had symptoms for over 3 weeks.
59 2021-05-09 tingling Tingling in hands and feet,slight swelling of tongue,funny taste in mouth,pain in right ear,Benadryl... Read more
Tingling in hands and feet,slight swelling of tongue,funny taste in mouth,pain in right ear,Benadryl taken at home for 2 days after also tired , lightheaded and slight headache. Now Zyrtec daily .... itching and tingling occurs in various areas and continues today.
59 2021-05-09 cold extremities Hives, Red raised places on my skin, itching , painful joints and swelling at the joints, cold finge... Read more
Hives, Red raised places on my skin, itching , painful joints and swelling at the joints, cold fingertips, chills
59 2021-05-10 weakness pt stated that they felt weak 30 minutes after receiving vaccine. pt drank some water. Then after an... Read more
pt stated that they felt weak 30 minutes after receiving vaccine. pt drank some water. Then after another 15 minutes pt complained of being cold. tried to move pt into vaccination room for privacy. pt was unable to stand on her own. checked with pt then called ambulance.
59 2021-05-10 bell's palsy facial symptoms; Bell's Palsy.; headache; This is a spontaneous report from a contactable consumer (... Read more
facial symptoms; Bell's Palsy.; headache; This is a spontaneous report from a contactable consumer (patient). This 59-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 25Mar2021 10:30 AM (Lot Number: ER8733) at the same age as single dose for COVID-19 immunisation. Medical history included Herpes (although no symptoms or outbreaks for 20+ years). Concomitant medications included estradiol (ESTROGEN) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 04Mar2021 11.30am (Lot Number: EN6206) as single dose for COVID-19 immunisation. The patient experienced Bell's Palsy and first had headache on 12Apr2021, first facial symptoms appeared on 16Apr2021. The adverse event result in: Doctor or other healthcare professional office/clinic visit. Treatment was received for the events including Prednisone and anti-viral. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant. Outcome of the events was recovering.
59 2021-05-10 hot flush had strange vision issues where I am dizzy and then I see spots and distortion of what is in front o... Read more
had strange vision issues where I am dizzy and then I see spots and distortion of what is in front of me off and on; extreme dizziness and tiredness; extreme dizziness and tiredness; infectious mononucleosis; had a lot of brain fog; extreme lethargy to the point of wanting to sleep it off every single day no matter how long she slept; sore all over her body like her joints are sore all over her body; sore all over her body like her joints are sore all over her body; hot flashes like when she went into menopause in the past; all she wanted to do was sleep all the time; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Apr2021 09:15 (Batch/Lot Number: ew0153) as single dose for covid-19 immunisation. Medical history included hot flush from an unknown date and unknown if ongoing (went into menopause in the past), menopause from an unknown date and unknown if ongoing menopause. The patient previously took Tequin and experienced allergy. Patient reported of taking daily vitamins and supplements in 2 weeks timeframe of vaccination. There were no other vaccines in 4 weeks. Patient did not have COVID prior to vaccination. On Day 1, 11Apr2021 at 09:15 am, the patient experienced extreme dizziness and tiredness. Day two and on, patient still getting the side effects. Patient stated "I felt like I have mono". She expressed that she was "dog tired" every single day. She reported of also had a lot of brain fog. She had extreme lethargy to the point of wanting to sleep it off every single day no matter how long she slept. Patient reported of also experienced "strange vision issues where I am dizzy and then I see spots and distortion of what is in front of me off and on". The patient was sore all over her body like her joints are sore all over her body. She experienced hot flashes like when she went into menopause in the past. All of these symptoms come and go but the lethargy and brain fog continued and has not gone away now 12 days has past since she got her first shot. She stated that all she wanted to do was sleep all the time. The outcome of events was not recovered. No treatment was received. Patient did not test for COVID post vaccination.
59 2021-05-10 pain in extremity Mouth broke out; zit that broke out on the top of her eyebrow. There are hard little bumps; they wer... Read more
Mouth broke out; zit that broke out on the top of her eyebrow. There are hard little bumps; they were red and hard; Arm was sore; puffy/swollen; She had a breakout on her face, a couple of lesions, and her mouth broke out.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included allergic to Penicillin, crustaceans, shellfish, and mushrooms. Those were what she usually had a breakout for. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug allergy and second degree burns. Her reaction to amoxicillin was probably 15 years before. The patient had a reaction to her first Covid-19 shot. She took the first shot last Tuesday. She had a breakout on her face, a couple of lesions, and her mouth broke out. It looked like a reaction. She took a couple of diphenhydramine hydrochloride (BENADRYL), and it was going away. Her second shot was scheduled for next Tuesday 11May2021. She needed to know if there was anything in the shot that would cause this. She was leery of taking it. She was okay with it, and the diphenhydramine hydrochloride was fine. She did contact her doctor. That was it, she had nothing else just the breakout. She thought it was maybe Thursday 22Apr2021 or Friday 23Apr2021 that she noticed the breakout on her face. She started trying to take some diphenhydramine hydrochloride. It was rapid when it happened, not slow. She saw these as almost like a reaction. She had welting on the skin similar to a reaction to dust mites. There was this thing she thought was just a zit that broke out on the top of her eyebrow. There were hard little bumps. One had gone away, and the other was still there. It was almost like when she had a breakout of zits was kind of what she would say. It was dissipating. She started taking rounds of diphenhydramine hydrochloride to stop the reaction, and it was working. She was concerned about the second shot. She didn't know if it was an allergic reaction to amoxicillin or any other type of medicine if it was in there. That was what she was concerned about. Before she got the second shot she needed an idea of what might have happened. The lesions came a day or so after the breakout on her face. She would say Sunday 25Apr2021 was when she saw the lesions above her eyebrows. It was right at the beginning of her eyebrow. It was really hard at first. It was not itching, just like zits. Similarly, they were red and hard. Once again she started the diphenhydramine hydrochloride and saw a little bit of difference, but had to keep putting on topical Aquaphor and cocoa butter. She had to keep putting it on there, it was just swollen. The lesions were puffy and red. There was just one left, it was going down. Her mouth was the number one thing. She thought it was from wearing a mask. She had never had a breakout with a mask before. She took the shot on Tuesday, and her arm was sore just for 24 hours. She noticed her mouth broke out Thursday or Friday for sure when she woke up. At first she just kind of forgot about the shot and didn't put two and two together. She took diphenhydramine hydrochloride. It was the same type of reaction she would have if it was amoxicillin. She really needed to know if she should anticipate something with the second shot. Outcome of event a breakout on her face, a couple of lesions, and her mouth broke out was resolving, and of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-05-10 pain in extremity Medical history included ongoing asthma, ongoing hypertension, ongoing mitral valve prolapse, ongoin... Read more
Medical history included ongoing asthma, ongoing hypertension, ongoing mitral valve prolapse, ongoing Tarlov cysts. The concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) for Pain. The first vaccine she had no problems and just soreness in her arm on an unspecified date. The event outcome was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-05-11 weakness Pt called to report a reaction to the second Pfizer vaccine. She reports that day 2 she had itching... Read more
Pt called to report a reaction to the second Pfizer vaccine. She reports that day 2 she had itching in both arms, and day 4 had a full body rash. She took 1/2 a benadryl with some relief. Then, day 10 after this shot, she experienced low energy, emotional lability and muscle aches and pains. Last night she experienced severe muscle aches that woke her up, they are better this am. She cannot take ibuprofen as she has had a nephrectomy. She was not referred to allergy, but was encouraged to contact her PCP re any other meds that she could take for pain. She is using topical methods like heat and massage with some relief.
59 2021-05-11 bell's palsy Diagnosis of Bells Palsy on 14Apr2021; This is a spontaneous report from a contactable consumer. A... Read more
Diagnosis of Bells Palsy on 14Apr2021; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), dose 1 via an unspecified route of administration, administered in the left arm on 26Mar2021, at 11:00 as single dose for covid-19 immunization. Medical history included hypertension from an unknown date . No known allergies were noted. There were no concomitant medications. The patient had diagnosis of Bells palsy on 14apr2021 on 14Apr2021, at 06:00. The event resulted in Emergency room/department or urgent care visit. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of diagnosis of bells palsy on 14apr2021, and included treatment with predisone (x 5 days) and anti-viral (x 10 days). The outcome of diagnosis of Bells palsy on 14apr2021 was not recovered.
59 2021-05-11 burning sensation arm started burning, hives on roof of mouth, developed ringing in the ears that wont go away. Pro... Read more
arm started burning, hives on roof of mouth, developed ringing in the ears that wont go away. Provider only said to take Benydral.
59 2021-05-11 pain in extremity The symptoms were similar as what I had both when I had COVID 19 in November 2020 and who I had the ... Read more
The symptoms were similar as what I had both when I had COVID 19 in November 2020 and who I had the first vaccine. The evening of the (5/4/21) shot I felt achy, feverish and had the chills. I had difficulty sleeping the first night and my left arm ached severely. I took Tylenol to relive all of the discomfort. The day after the shot (5/5/21) I didn't feel well, and took some Tylenol, upon starting to feel feverish. In the morning I could function normally until about 3:00 pm, when I was very fatigued, achy and had a mild fever, and chills. I continued taking Tylenol, and slept from about 4:00 pm through the night. The third day (5/6/21), I felt better but still fatigued. The achiness and chills were gone. However that evening I felt a bit feverish. The fourth day (5/7/21) I felt 100% back to normal. Subsequent days I have some fatigue in the afternoon but am not sure it is related to the vaccine.
59 2021-05-11 tremor Chills, shakes, fever over 102, severe joint pain and muscle pain, swelling in hands and face, nause... Read more
Chills, shakes, fever over 102, severe joint pain and muscle pain, swelling in hands and face, nausea, arm swollen to size of softball, feeling like the worse case of a bug I have ever had.
59 2021-05-12 weakness Sunday evening 5/9/2021 - Extreme nausea. (Vomited 2x). Body aches started in lower back but moved... Read more
Sunday evening 5/9/2021 - Extreme nausea. (Vomited 2x). Body aches started in lower back but moved around to different parts of body. Extreme fatigue. Headache (Left side of head), Earache (Right Ear). Soreness at injection site. Loss of appetite. Some disorientation. Monday am - Nausea, vomiting, dry persistent cough, loss of appetite, extreme fatigue (stayed in bed all day). Appetite returned around 11pm. Headache (intermittent). Muscle aches moved around to different parts of body. Used heating pads and ice-packs. Tuesday am - Fatigue, still sore at injection site, winded when walking slowly, some disorientation, overall body tiredness. Wednesday noon - Fatigue, soreness at site, winded during light short swim, appetite depressed. Thursday - Fatigue, disorientation, loss of energy. After the 1st shot in the series I had nausea and vomiting. Also experienced extreme fatigue. One important factor is that I had TKR surgery on right knee February 18, 2021. Maybe it was too soon after surgery to receive the vaccination? My husband had same shot, same day, same Lot#. His side effects only lasted 1 day but were isolated to soreness at injection site and overall fatigue and muscle pain but only in lower back.
59 2021-05-12 pain in extremity, weakness Swelling of the face, fast heartbeat, dizziness weakness tiredness terrible headache muscle pain chi... Read more
Swelling of the face, fast heartbeat, dizziness weakness tiredness terrible headache muscle pain chills sweated at night swollen site injection nauseated feeling unwell diarrhea arm pain extreme feeling very very weak .
59 2021-05-12 pain in extremity My left arm pain started the same night of the 2nd dose of Covid-19 vaccine. It is still pain now af... Read more
My left arm pain started the same night of the 2nd dose of Covid-19 vaccine. It is still pain now after 5 week from the shot.
59 2021-05-13 facial paralysis Right Facial Palsy
59 2021-05-13 pain in extremity Dose 1, I had to wait 30 minutes due to my allergies. I felt I was having heart palpitations, so I s... Read more
Dose 1, I had to wait 30 minutes due to my allergies. I felt I was having heart palpitations, so I stayed developed a migraine by the time I got home, which lasted a few days. I had minimal arm soreness. About 5 days later, I had body aches, chills and I felt like I had a cold or flu. I just felt crappy. Those symptoms lasted about 5 days. I had another COVID test to make sure I hadn't contracted it, but it was negative. Dose 2 - Sore arm and headache. Two days later, I was very achy and had chills. Took Tylenol and my symptoms lasted about 2-3 days.
59 2021-05-14 inability to speak, weakness, pain in extremity weak; blood pressure (BP) and it was 131/104, her pulse was 104; cognitive problems/forgetting words... Read more
weak; blood pressure (BP) and it was 131/104, her pulse was 104; cognitive problems/forgetting words/forget what she was going to say it would take a while, like a brain fog; forgetting words/forget what she was going to say it would take a while, like a brain fog; she would forget what she was doing; she felt unwell; she was wheezing a bit; exhaustion; cough; body aches/bad pain; pain in all of her left arm where she got the injection; pain in the left side of chest; her heart was hurting; her heart was really pounding, like she was in a race/pulse was 104; her temperature it was not too high, it was 99.5 so not over 100; very severe headache with dizziness; nausea; very severe headache with dizziness; she could not fall asleep; pre-existing condition (chronic motility issues) got worse; pre-existing condition (chronic motility issues) got worse; upset stomach; severe abdominal pain; This is a spontaneous report from a contactable consumer (who is also the patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170), via an unspecified route of administration, on 16Apr2021, as 1st dose, single, for COVID-19 immunisation. Medical history included hypotension from an unspecified date, and chronic motility issues from 2017 and ongoing. The patient's concomitant medications were not reported. On 16Apr2021, the patient received the first dose of BNT162B2 and got slightly dizzy immediately after the vaccine. Her arm did not hurt, and she was okay until she went home. She had nausea and headache. She went to sleep and woke up after 12 midnight (17Apr2021) with a really bad headache and her heart was pounding like she was in a race. She also had pain in all of her left arm where she got the injection, body aches and pain in the left side of chest, like her heart was hurting. She checked her temperature it was not too high; it was 99.5 so not over 100. She took Tylenol 100 mg. She woke up at 2:00 and still had headache. It took all night to help her headache and she took another Tylenol 500 mg. When she woke up next morning, she still had a headache but not as severe. She thought okay this is going to be the usual thing and go away in a couple of days. She reported that from 16Apr2021, she could not fall asleep and would get a headache which got worse as she was not falling asleep. On 17Apr2021 and 18Apr2021, the patient experienced really bad pain, her arm was hurting, and she kept taking Tylenol. On 18Apr2021, she started coughing so she took Robitussin for the cough. On the same day, 18Apr2021, she had body aches, nausea and was exhausted. She mentioned that she is a very active person, an avid cyclist, and normally walks 10 miles, but when she walked a couple of miles, she was exhausted and could not do anything else. It was very difficult for her and it was unusual. She was still experiencing the events on 19Apr2021 and 20Apr2021. So, on 21Apr2021, she went to her primary care physician's office but saw another doctor who was available that day. The doctor checked if her legs were swollen and checked her lungs. The doctor stated the patient was wheezing a bit but did not see anything else. The doctor advised her not to take the second dose. The patient mentioned that her pre-existing condition (chronic motility issues) got worse. In Apr2021, experienced upset stomach, severe abdominal pain. On 22Apr2021, she woke up and felt totally fine. She thought the symptoms were finally going away. But at 17:00, she felt unwell, had body pain, headache, and she was coughing again. She went to sleep and woke up on 23Apr2021 at 04:30. She woke up with a severe headache, extreme nausea (no vomiting), was really weak, dizzy, absolutely exhausted. She still had exhaustion, nausea, body aches, and cough. She checked her blood pressure (BP) and it was 131/104, her pulse was 104. She took Tylenol 1000 mg and the symptoms did not go away so she took another Tylenol 500 mg. After an hour, her headache was not better, dizziness was bad, but her BP was going down. She called the nurse line and was advised to go to the ER. At the ER, she was given IV fluids to hydrate and pain medications. She was then tested for COVID-19 which came back negative. The patient also had cognitive problems. By the time she got to the ER, she was forgetting words (she would try to say something and she would forget what she was going to say it would take a while, like a brain fog) and she would forget what she was doing. She would catch herself forgetting and not remembering words. The patient wanted to know if she should get the second dose, how long should she wait until she gets her second dose, how long do the side effects last, will the side effects from the second dose be worse, how the vaccine works, asked the ingredients of the vaccine, and asked if there is a need for a third dose. The patient assessed the events dizziness, nausea, headache, pain in arm, chest pain, fatigue, body aches/bad pain and cough as serious (medically significant). The patient was recovering from dizziness, headache, body aches/bad pain, hypertension, cognitive disorder, aphasia and memory impairment. The outcome of the events nausea, fatigue, and cough was not recovered. The outcome of the remaining events was unknown.
59 2021-05-14 weakness Five days after my Pfizer shot (05/13/21), woken up by extreme dizziness while turning on my side in... Read more
Five days after my Pfizer shot (05/13/21), woken up by extreme dizziness while turning on my side in bed. Was nauseous, with vomitting and diarrhea, chills, sweats, tinnitus, for 4 hours. Had eaten shrimp for dinner, and thought I might have food poisoning, but was so weak, disoriented, and alone that I called 911 for help. Was taken to the hospital. Three hours later, was given meclizine and hydration intravenously, a CAT scan, and sent home. Felt ok Fri (05/14/21). Haven't picked up any meclizine yet, but was/am using dimenhydrinate, which is becoming less effective today (05/15/21).
59 2021-05-15 pain in extremity Arm pain, injection site pain, diarrheah, dizziness, general feeling of unwellness, slight feverr, h... Read more
Arm pain, injection site pain, diarrheah, dizziness, general feeling of unwellness, slight feverr, headache
59 2021-05-16 migraine following the vaccine she had migraine for 2 days then the third day she developed severe cough with... Read more
following the vaccine she had migraine for 2 days then the third day she developed severe cough with difficulty breathing. wheezing lasted 3 weeks. had negative covid test at cvs. patient was seen at er. also negative covid test at ER. she was given steriods, albuterol inhaler in the ER then regular doctor added azithromycin.
59 2021-05-17 feeling cold Uncontrollable shivering and freezing cold, 14 hours after shot. Fainting, 20 hours after shot.
59 2021-05-18 numbness Patient notes that she has had increased issues with her vision since she had her first dose of Pfiz... Read more
Patient notes that she has had increased issues with her vision since she had her first dose of Pfizer vaccine on April 7, and she has decided not to pursue the second dose at this time. She's had some numbness and swelling in her mouth afterwards that took 3 days to resolve. Also exacerbation of her asthma with SOB, which improved when she arrived home and used her MDI.
59 2021-05-18 tremor She got her vaccine, within 5 minutes she felt a headache coming on. Within an hour it was much wor... Read more
She got her vaccine, within 5 minutes she felt a headache coming on. Within an hour it was much worse, and then as the evening progressed within 2-3 hours it was severe. Her arm is also sore and she feels shaky and not well. She took some Tylenol PM last night and they did not work, and she just took some Excedrin migraine for the pain as well . The headache is not getting any better, just feels like something is sitting on her head.
59 2021-05-19 discomfort Increasing the itchiness. now in my legs too/itchiness in my skin; Rash in my left side of my face, ... Read more
Increasing the itchiness. now in my legs too/itchiness in my skin; Rash in my left side of my face, neck , ears, arms and chest; My under left eye was swollen & redness; My under left eye was swollen & redness; It's very uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 22Apr2021 12:15 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included hypertension, depression and known allergies: yes from an unknown date and unknown if ongoing. Concomitant medications included losartan; escitalopram oxalate (LEXAPRO); bupropion; hydrochlorothiazide all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 59-years-old, via an unspecified routed of administration administered in left arm on 01Apr2021 12:15 (lot number was not reported) for covid-19 immunization. The patient reported 2 days after her second vaccine, she was with rash in the left side of her face, neck , ears, arms and chest. Her under left eye was swollen & redness. Increasing the itchiness now in her legs too. It's very uncomfortable. The events occurred on 24Apr2021 06:00. She have been using several products over the counter such as Zyrtec, Benadryl cream, Caladryl, Hydrocortisone, Aveeno body wash and Curel lotion. But still suffering of the itchiness in her skin. The patient did not recover from the events. Information on the lot/batch number has been requested.
59 2021-05-19 migraine Chills, Migraine, aches, Feels like I have a fever, but don't.
59 2021-05-19 migraine stroke like symptoms; similar to migraines; mini-strokes; Passing Out; Blind spots in her vision; Na... Read more
stroke like symptoms; similar to migraines; mini-strokes; Passing Out; Blind spots in her vision; Nausea; Believes it effected her memory; stroke like symptoms; similar to migraines; mini-strokes; This is a spontaneous report received from a contactable consumer. A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Apr2021 (Lot Number: EW0153; Expiration Date: 31Jul2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 59 years). Medical history included ongoing strokes, ongoing third and fourth Nerve Palsy. Concomitant medications included dabigatran etexilate mesilate (PRADAXA) taken for blood thinner; metoprolol for Stroke, Heart regulation; lovastatin taken for Stroke, Heart regulation. The patient states that she went to the Emergency Room on 17Apr2021 and then went again on either 18Apr2021 or 19Apr2021. The patient states she does not know if she was admitted or not. States that she thinks she just was in the emergency room the time that she was there. Says that after the Covid Vaccine she was having stroke like symptoms; similar to migraines; mini-strokes. She was passing out, had nausea, blind spots in her vision, and she believes it effected her memory. The events occurred on 17Apr2021. Also, she said on her first emergency room visit they did a CT Scan and on her second emergency room visit they did a MRI and both was not reported. States they told her there was no issues. The patient underwent lab tests and procedures which included CT Scan: and MRI: not reported on Apr2021. Outcome of the event vision impairment was not recovered while outcome of the event nausea was recovered on Apr2021. Outcome of the event memory impairment was recovering while outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-05-19 tremor Immediately after administration, patient stated tingling in throat, sweating and shakiness. Asked ... Read more
Immediately after administration, patient stated tingling in throat, sweating and shakiness. Asked if patient is diabetic ( she did say no to all chronic health conditions on question form). stated she could be hypoglycemic and nervous. We monitored for 5 minutes and she complained of difficulty breathing upon which I asked if she wants me to administer EpiPen and she said "yes". I administered EpiPen 0.3mg in right tight. After EpiPen she seamed to calm dowm. 911 was called as the EpiPen was administered. After EMS came, patient walked on her own to get her vitals checked. Shortly after leaving, pharmacy received call from patient her self that she is home and feel normal. Followed up with patient an hour later and she is still doing well.
59 2021-05-20 muscle spasms Severe shaking chills with muscle spasms for 2 hours on 1/22/2021. Fever ranging from 99.5 to 102.0 ... Read more
Severe shaking chills with muscle spasms for 2 hours on 1/22/2021. Fever ranging from 99.5 to 102.0 F for 46 hours in a row, even with Tylenol 1000 mg every 6 hours regularly during that time. Fever never went to normal temp. Time period was starting at 07:30 pm 1/22/21 until 05:30 pm 1/24/21. Additional symptoms during that time period was headache, nausea, loss of appetite, muscle weakness all over, muscle aches all over, pain in hip joints, localized pain at injection site without redness. After 1/24/21 5:30pm dry cough and shortness of breathe developed for following 5 days, causing me to stop with heavy breathing after 1 flight of stairs which normally I can climb without any heavy breathing. Heavy breathing with this same activity level continued then for 3 additional weeks, but I would not have to stop the activity, just breathe heavily. And intermittent dry cough continued also for this time period (total of 3 weeks 5 days).
59 2021-05-20 nerve pain Patient got the Shingles. This is the second time for this patient, the first occurrence of the Shin... Read more
Patient got the Shingles. This is the second time for this patient, the first occurrence of the Shingles was in March of 2020
59 2021-05-20 pain in extremity Fever, body aches, very sore arm, fatigue Lasted about 30 hours.
59 2021-05-21 muscle spasms knot above her shoulder blade on her collar bone; swollen gland around her left collarbone; back spa... Read more
knot above her shoulder blade on her collar bone; swollen gland around her left collarbone; back spasms; nausea; sore arm in her left arm which was the injection arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 17Apr2021 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included nifedipine (NIFEDIPINE) taken for blood pressure increased from Feb2021 and ongoing; betacarotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL) taken for immune system disorder from 2020 and ongoing; 1-alpha-hydroxyvitamin d3 (1-ALPHA-HYDROXYVITAMIN D3) taken for immune system disorder, bone disorder from 2020 and ongoing. The patient stated she received her first Pfizer Covid vaccine dose on 17Apr2021. That same day she started to experience nausea which resolved. She also experienced a sore arm (injection arm was left arm) for a few days, which has resolved. She reported back spasms on 26Apr2021 which have since resolved. She stated she began to have a swollen gland around her left collarbone on 27Apr2021 which continues to be swollen. Around 5-6 days after, she experienced a knot above her shoulder blade, on her collar bone. She went to get her 2nd shot today, and told them about the knot, it does not hurt, and they advised she go see a doctor. The outcome of the event knot above her shoulder blade on her collar bone was unknown, event swollen gland around her left collarbone was not recovered while other events were recovered on an unspecified date.
59 2021-05-21 tingling tingling all over the body and tongue, no SOB or tongue swollen Benadryl po given declined tent O... Read more
tingling all over the body and tongue, no SOB or tongue swollen Benadryl po given declined tent OBS
59 2021-05-22 pain in extremity First, let me start by saying I had COVID-19 in March 2020. I had my antibodies tested and still ha... Read more
First, let me start by saying I had COVID-19 in March 2020. I had my antibodies tested and still had positive antibodies in March 2021. I had the first vaccine and experience multiple adverse events over a 2-3 week period. The expected were sore arm, tiredness, chills, headache, body aches. The unexpected were: bad joint pain, feeling like someone was putting a searing hot poker in body, terrible vertigo (never had this before) and a slight dizziness/wooziness that lasted a couple of weeks. I opted out of the 2nd dose....
59 2021-05-23 pain in extremity At night on 5/11, I had onset of upper arm, shoulder and lower leg discomfort bilaterally. Over the... Read more
At night on 5/11, I had onset of upper arm, shoulder and lower leg discomfort bilaterally. Over the following couple of days, the pain intensified in my shoulders and upper arm, but much worse on the right side. Over time, the pain has subsided somewhat on the left side, with some left side shoulder pain continuing. On the right side, I continue to have shoulder and upper arm pain of varying intensities, made worse with movement, and also worse at night. My right lower arm and hand are extremely painful and my hand is now stiff and quite painful to move. Lower arm and hand movement on the left side is made worse with movement and at night.
59 2021-05-23 pain in extremity pt states the next day she had a painful left arm. She had a developed a red rash on her neck. She... Read more
pt states the next day she had a painful left arm. She had a developed a red rash on her neck. She noticed a red rash on upper part of her right chest area. After she showered she noticed another red patch of bumps in other areas on her body. It is now more like hives and itching. The rash if from her scalp to her feet. Pt will contact her PCP.
59 2021-05-24 cold extremities Fingers turned ice cold - toes turned blue and ice cold - 2nd toe on each foot had large purple patc... Read more
Fingers turned ice cold - toes turned blue and ice cold - 2nd toe on each foot had large purple patch. Symptoms lasted for over an hour. Vitals stayed fine.
59 2021-05-24 seizure PATIENT WITH HISTORY OF SEIZURES WENT INTO A SEIZURE ABOUT 5 MINUTES AFTER ADMINISTRATION. PATIENT A... Read more
PATIENT WITH HISTORY OF SEIZURES WENT INTO A SEIZURE ABOUT 5 MINUTES AFTER ADMINISTRATION. PATIENT ALSO HAD SEIZURE WITH 1ST DOSE.
59 2021-05-25 feeling cold, inability to speak Within 2 minutes and her heart rate was over 112 beats per minute. Alsolso felt dizziness, lighthead... Read more
Within 2 minutes and her heart rate was over 112 beats per minute. Alsolso felt dizziness, lightheaded, vertigo, brain fog, tinnitus, rash on upper back, puffy red lips, white spots on the soles of the feet, stomach cramps, had problems forming sentences,had a hard tine even trying to call husband, itchy eyes, felt itchy and hot on her injection arm, had difficulty breathing, had to to take deep breaths, chills, freezing, headache, tongue started to swell, neck started to swell in the thyroid area, started to feel tired and sleepy, had to get assisted to the bathroom, the walls started to move in. The patient took Claritin 1 hour and a half i because they didn't want to give her her epi pen because her heart rate was too high and she is allergic to Benadryl. Stayed at the site for 2 hours, drank a lot of water, couldn't walk and she had to stay in a wheelchair. She said it took around 2 weeks to feel normal. She had spells of feeling dizzy and confused with brain fog for 2 weeks. Felt tinnitus for around 10 days after the vaccine. tinitis lasted 10 days brain fog 2 weeks: didn't know how to figure out how to turn car on. fatigue lasted about 4 weeks white spot on feet went away 2 weeks.
59 2021-05-25 feeling hot 45 minutes after the first vaccine of the Pfizer had a reaction that consisted of ears itching and g... Read more
45 minutes after the first vaccine of the Pfizer had a reaction that consisted of ears itching and getting hot. Patient took prednisone and better within hours.
59 2021-05-25 pain in extremity She couldn't turn her neck and her shoulder and collar bone and her chest hurt and it's getting wors... Read more
She couldn't turn her neck and her shoulder and collar bone and her chest hurt and it's getting worse; She couldn't turn her neck and her shoulder and collar bone and her chest hurt and it's getting worse; her right arm was sore from her shoulder to her neck to the top of her chest on the right side / her chest hurt and it's getting worse; right arm was sore from her shoulder to her neck to the top of her chest on the right side; right arm was sore from her shoulder to her neck to the top of her chest on the right side; right arm was sore from her shoulder to her neck to the top of her chest on the right side; This is a spontaneous report from a contactable consumer or other non hcp from United States. The following was Reported by patient herself. A 59-years-old female patient received bnt162b2 (bnt162b2), dose 2 via an unspecified route of administration, administered in Arm Right on 24Apr2021 15:00 (Batch/Lot number was not reported, Expiry Date: Unknown) as single dose (at the age of 59-years-old) for covid-19 immunization. The patient previously took first dose on 03APR2021 via an unspecified route of administration, administered in Arm Right (Batch/Lot number was not reported, Expiry Date: Unknown) as single dose for covid-19 immunization. With the first Covid 19 vaccine she just had a sore arm (on 04Apr2021) the day after she received her vaccine. The soreness only lasted a day. Medical history included covid-19 from 11Mar2021 to an unknown date, ongoing arthritis, ongoing type 2 sugar diabetes, ongoing high blood pressure and ongoing lower lumbar sciatica. Patient reported that she had the Covid 19 virus on 11Mar2021. The patient's concomitant medications were not reported. When probing concomitant medications caller reports she takes her regular medications, nothing new has been prescribed. She declines to provide her medications for the report. Patient has no history of prior vaccinations (within 4 weeks). No other events were reported following prior vaccinations. Next day of receiving second dose on, 25Apr2021 her right arm was sore from her shoulder to her neck to the top of her chest on the right side. It's gotten worse since then. She couldn't turn her neck and her shoulder and collar bone (on 25Apr2021). Patient also complained of chest hurt which was reportedly getting worsened. There was no emergency room nor physician office visit for events. The outcome of events was not recovered. No relevant tests were done. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Reason for no lot number: The caller reports the vaccine record card does not have an NDC/Lot/Expiry for either dose. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
59 2021-05-25 tingling An hour after vaccination, patient developed weakness in her right leg and tingling in her fingers i... Read more
An hour after vaccination, patient developed weakness in her right leg and tingling in her fingers in both hands. By the time she reached home, she experienced chest palpitation and her blood pressure was elevated. She rested at home and drank fluid for one day. Next morning, she experienced headache and dizziness. As it wasn't going away, she went to the emergency at Medical Center where they conducted radiographic test and blood test and found no abnormalities. Patient no longer have those symptoms after visit to the ER at Medical Center.
59 2021-05-25 tingling Tingling pins and needles on my hands; Blurred vision; This is a spontaneous report from a contactab... Read more
Tingling pins and needles on my hands; Blurred vision; This is a spontaneous report from a contactable consumer (patient) from COVAES. This 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8733) via an unspecified route of administration in the left arm on 23Apr2021 at 11:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin and shellfish allergies, both from unknown dates and unknown if ongoing. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included prednisone from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number not reported) on 02Apr2021 at 11:30 (at the age of 59-years-old) for COVID-19 immunisation. The patient reported the evening of her vaccination she noticed some blurred vision and tingling pins and needles on her hands on 23Apr2021 at 18:00. She reported that because she was concerned about it, she kept watch of it until she fell asleep and in the morning she called her doctor's office who suggested she go to the emergency room for possible neurological effects. The events required an emergency room and physician office visit. The clinical outcomes of blurred vision and tingling pins and needles on her hands were recovering. It was also reported that the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are needed. No further information is expected.
59 2021-05-26 difficulty speaking, feeling hot She has 7 minutes into her waiting time after the vaccine. She states she became hot and dizzy. She ... Read more
She has 7 minutes into her waiting time after the vaccine. She states she became hot and dizzy. She had a feeling of swelling to her throat and tongue and hoarseness. She was given Benadryl orally and EMS was activated. They took her to the hospital and she left before getting seen. She comes into clinic today with continued complaints of dizziness, hoarseness, and diarrhea. This has been going on since her injection on 5/6/2021.
59 2021-05-26 pain in extremity Covid arm. Raised red welt on day 11 with pain; Covid arm. Raised red welt on day 11 with pain; very... Read more
Covid arm. Raised red welt on day 11 with pain; Covid arm. Raised red welt on day 11 with pain; very painful into shoulder blade; still painful into neck as well; Red circle around injection site; This is a spontaneous report from a contactable consumer. This 59-years-old non-pregnant female consumer (Patient) received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 19Feb2021 02:45 PM (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Penicillin. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced covid arm, raised red welt on day 11 with pain, very painful into shoulder blade, still painful into neck as well and red circle around injection site; all on 02Mar2021 at 04:00 PM. It was reported that Covid arm. Raised red welt on day 11 with pain. Better day 2, 3 day very painful into shoulder blade. Day 4 still painful into neck as well. Red circle around injection site. No treatment was received. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
59 2021-05-28 pain in extremity, burning sensation Caller received the first dose of the Pfizer COVID-19 vaccine and has experienced stinging and burni... Read more
Caller received the first dose of the Pfizer COVID-19 vaccine and has experienced stinging and burning sensation that was not attributed to the needle; Caller received the first dose of the Pfizer COVID-19 vaccine and has experienced stinging and burning sensation that was not attributed to the needle; Arm was sore; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration in Arm Left on 20Jan2021 11:50 (at the age of 59-years-old) (Batch/Lot Number: EK9231) as single dose for covid-19 immunisation. Medical history included myocardial infarction from an unknown date and unknown if ongoing Heart attack 6-7 years ago, anxiety, anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medication(s) included carvedilol 6.25 mg twice daily taken for myocardial infarction, clopidogrel 75mg once daily taken for anticoagulant therapy, rosuvastatin 20mg once daily taken for hypercholesterolaemia, escitalopram 10mg once daily taken for anxiety start and stop date were not reported. There was no AE(s) following prior vaccinations that sometimes when she gets the flu shot, she gets the feeling of the flu after, but it's minor. None other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient experienced stinging and burning sensation that was not attributed to the needle and arm was sore on 20Jan2021. The patient received her 1st dose about 2 weeks ago and had no issues, but as she had spoken with other people that have gotten it, it left her thinking. She asked when you get a shot and sometimes you feel the pinch, and sometimes it burns. Further stated that everyone she talked to said it was nothing for them; they didn't have that burning. But for her it burned during the injection and for 10 minutes after. Also states that her arm was sore the next day, which she expected. And everyone else said they had the arm soreness to, but no one had said that it burned during the injection. She just wanted to make sure that she was getting the right thing and was getting the protection. Caller clarified and stated that the burning lasted about 20 minutes after the injection. When asked what time she got her injection, caller stated that her memory was so bad, but she thought it was around 11:50am. The AE did not require a visit to emergency room or physician office. List other relevant diagnostic and confirmatory test results for event(s) was none. Outcome of the event (Caller received the first dose of the Pfizer COVID-19 vaccine and has experienced stinging and burning sensation that was not attributed to the needle) was recovered on 20Jan2021 while event (Arm was sore) was recovered on 22Jan2021. Follow-up attempts are completed. No further information is expected.
59 2021-05-28 tingling, pain in extremity, numbness The day after my second injection I began to feel Painful Numbness & Tingling in my hands/arms and m... Read more
The day after my second injection I began to feel Painful Numbness & Tingling in my hands/arms and my legs and feet. Swelling of my legs & feet, socks leaving big indents in my skin. Off and on headaches, an intense itch at times, all over, blisters on my butt(2) that "popped" and left the skin open and raw. I also just feel "off", do not feel like myself, a little bit unsure about my footing...
59 2021-05-30 weakness, pain in extremity, fibromyalgia I had the fist shot in the arm that had the surgery, within 10 minutes I was in a lot of pain were ... Read more
I had the fist shot in the arm that had the surgery, within 10 minutes I was in a lot of pain were the surgery was preformed. Felt like it went to my joints such as my knees. Chills, weak and been unusually tired, this never went away. My second Covid shot was May 13, the same thing happened same arm, 10-15 minutes later pain shoots down my arm to my wrist where the surgery was performed. Then my joints, so much pain brought me to my knees in tears. Experienced chills and ached all over Exhausted with periods its hard to stay awake. Now I feel like it has settled in my joints especially my knees where fibromyalgia is the worst, I need an cane to walk. I received ab cortisone shot in each knee on 5/21/21. no help, now my right calf hurts to walk even with cane. On May 26 I started my period. I havent had an period in 6 years, I'm 59 years old.
59 2021-05-30 tingling, weakness, numbness Severe tingling weakness and numbness in right leg and foot, joint pain, muscle pain extremities, ha... Read more
Severe tingling weakness and numbness in right leg and foot, joint pain, muscle pain extremities, hardness in muscle spots. Was prescribed predisone 1 week course, Applying ice and heat to effected area, stretching and gym every other day Been taking Tylenol 8 Arthritis post predisone since no effect on pain or tingling. Neurologist next step. Been 1 month 5 days post vaccine with no change in symptoms besides some increase in joint pain all over. Did not do 2nd dose. Reported to pharmacy reasons not doing 2nd dose. They said have had others with similar side effects
59 2021-05-31 mild one side paralysis Patient presented to the ED with acute left-sided weakness and was subsequently hospitalized within ... Read more
Patient presented to the ED with acute left-sided weakness and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Per doctor's notes: Stroke workup including MRI has been unremarkable. Patient was evaluated by general neurology and felt that her condition was most likely consistent with her hemiplegic migraines.
59 2021-05-31 numbness, pain in extremity, tingling Pain radiating down my arm and my upper whole right side of my body and in my head and then it went ... Read more
Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8732 and expiration dates were not reported), via an unspecified route of administration in arm left on 25Mar2021 as first dose, single for COVID-19 immunisation. The patient was also taking diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date for an unspecified indication and epinephrine (EPINEPHRINE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included Thyroid, High Blood Pressure and patient previously took benadryl for drug hypersensitivity and experienced drug hypersensitivity, epinephrine [epinephrine hydrochloride] for drug hypersensitivity and experienced drug hypersensitivity. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) 5 ug taken for an unspecified indication, from an unspecified date. The patient reported that she was calling to report an adverse reaction to first shot and she got the shot and about ten minutes after got the shot, she had a pain radiating down her arm and upper whole right side of the body and in her head and then it went numb and then about two minutes later, it tingled and she also had tingling on face and around her lips on 25Mar2021. The outcome of the event was recovering. Reason of delay: Daily spike of incoming calls due to COVID19 vaccine. No follow-up attempts are possible. No further information is expected.
59 2021-05-31 nerve pain, fibromyalgia Developed intermittent fibromyalgia flare-ups and neuropathy pain in both feet and legs. After 2nd v... Read more
Developed intermittent fibromyalgia flare-ups and neuropathy pain in both feet and legs. After 2nd vaccine, the flare-ups and neuropathy pain in my feet have become unbearable. This has been ongoing. The nortriptyline had been helping my pain until I received the vaccines. Since the vaccines the pain has reverted back to how it was when I was first diagnosed.
59 2021-06-01 numbness Facial numbness middle to left side of chin and over to check, including lower lip and tip of tongue... Read more
Facial numbness middle to left side of chin and over to check, including lower lip and tip of tongue. First spoke with dentist and he took xrays to see if there was anything related he did not see anything, suggested I see my doctor. Had appt. with my family doctor and she did bloodwork, only issue with bloodwork was very low B12, began a daily supplement. Family suggested I see a neurologist to figure out this numbness. Went to neurologist, had more bloodwork and an MRI.. MRI was negative and bloodwork showed low albumin. I did document this on my weekly check-in post vaccine and in May received a call from CDC to report this adverse event. I had not correlated this to the vaccine, but once the CDC called, I did investigate and it seems that this could very well be a side effect. I am hoping someone can help me find a doctor that can help correct this numbness, thank you~
59 2021-06-01 migraine neurological symptoms; developed a migraine headache; This is a spontaneous report from a contactabl... Read more
neurological symptoms; developed a migraine headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 01Apr2021 14:15 (lot number: ER8737) at the age of 59 years old, as 1ST DOSE SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed a migraine headache on 06Apr2021 and neurological symptoms on an unspecified date. The doctor and neurologist were testing her. Clearly migraines medication can't help it. Her physician is working with her other doctor to try to figure it out. He worked with other patients with long term side effects from the vaccine. She is wondering if there is any literature on migraines as a long-term side effect. She got the first vaccine on 01Apr2021. She started having migraines on 06Apr2021. She has tried taking multiple medications. She has been to the emergency room for and infusion, and she had an infusion at her neurologist office. She received Saline with magnesium and Toradol. She received Reglan, DHE, and Decadron. She also tried (withheld) CGRP 50mg and 100mg. She received the second dose 21Apr2021. The second lot was ER8735. She got the first vaccine in her left arm, and the second one in her right. She received the doses at 2:15pm. Migraine headache also required visit to Physician office. No prior vaccination within 4 weeks. No other AEs prior to vaccinations. All the blood work at hospital came out normal and kidney function was one marker a little out of normal range. The patient has not recovered from the events.
59 2021-06-01 pain in extremity, feeling hot 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with l... Read more
3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; Could not lift my arm and the pain was like an 8 of 10.; 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Also my left arm hurt so bad for 3 days; with lumps under her skin; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EWO179) via an unspecified route of administration on left arm on 03May2021 11:30 as 2nd dose, single for covid-19 immunization. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EWO158) via an unspecified route of administration on left arm on 12Apr2021 at 10:30 as 1ST DOSE, SINGLE for COVID-19 immunisation. Known allergies were none. Medical history and concomitant medications were not reported. She did not take any other vaccine in four weeks and no other medications within two weeks. On 06May2021 at 20:30 3 days & 9 hours after 2nd vaccine patient reported that she broke out in a rash on her chest neck and behind her ears, with lumps under her skin and felt hot. Took Benadryl at 21:00, in morning rash moved to stomach and left side. Event resulted in Doctor or other healthcare professional office/clinic visit. Then took Claritin and it disappeared. Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non-stop until 18:00 that evening. Also, her left arm hurted so bad for 3 days that she took Tylenol on day 2 after vaccine. Could not lift her arm and the pain assessment was like an 8 of 10 on 06MAY2021. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. The clinical outcome of all events was resolved on an unspecified date of 2021. No follow-up attempts are possible. No further information is expected.
59 2021-06-01 pain in extremity Fever; Nausea; Aches; Arm Pain; This is a spontaneous report from a contactable, consumer. A 59-year... Read more
Fever; Nausea; Aches; Arm Pain; This is a spontaneous report from a contactable, consumer. A 59-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021 at 15:00 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. The patient medical history included celiac disease, asthma, HBP- high blood pressure, SVT- Supraventricular tachycardia from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested negative for COVID-19. Concomitant medications included Bupropion (WELBUTRIN) , oestrogens, conjugated (PREMARIN), furosemide (MANUFACTURER UNKNOWN), ditiazem (MANUFACTURER UNKNOWN), omepraz (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Feb2021 at 06:00, the patient experienced fever, nausea, aches and arm pain. On 12Mar2021, the patient underwent nasal swab test (test name reported as IDnow) and test result showed negative. On 16Mar2021, the patient underwent COVID-19 nasal swab test again and rapid RT-PCR (Reverse transcription polymerase chain reaction) test and both test result showed negative. The patient did not receive any treatment for the events. The clinical outcome of the event fever, nausea, aches and arm pain was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
59 2021-06-01 pain in extremity She had a sore left arm after her first COVID-19 Vaccine dose, but other than that felt fine; She ha... Read more
She had a sore left arm after her first COVID-19 Vaccine dose, but other than that felt fine; She had a sore left arm after her first COVID-19 Vaccine dose, but other than that felt fine; This is a spontaneous report from a contactable consumer or other non hcp and from Pfizer-sponsored program. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm left on 21May2021 09:00 (Batch/Lot Number: EW0169) as 1st dose, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a sore left arm after her first Covid-19 vaccine dose, but other than that felt fine on 22May2021. Patient asked if it would be ok for her to take a herbal cleanse after receiving the first COVID-19 Vaccine, stating she wanted to make sure there wouldn't be any problem doing so. Patient also wants to know if the following ingredients would effect the vaccine: Magnesium Citrate, vitamin B6 (pyridoxine HCI) vitamin B12 (cyanocobalamin), sodium, potassium citrate, potassium sorbate, hexametaphosphate, sodium benzoate. Patient said she didn't notice the left arm soreness until upon waking on Saturday morning, 22May2021. She said her left arm was still tender, but the left arm soreness had improved. It was reported patient took TYLENOL (clarified as generic Acetaminophen 500mg), and (generic) Ibuprofen 200mg to treat her left arm soreness. She said she did not have the generic Acetaminophen 500mg and generic Ibuprofen 200mg NDC Numbers, Lot Numbers, and Expiration Dates to provide because she had transferred the generic Acetaminophen 500mg and generic Ibuprofen from their original product bottles to a smaller bottle that she kept in her purse. It was reported patient found a Manufacturer's Date (Oct2020), but did not see a Expiration date on the product's outer packaging or product bottle. She stated she purchased the Herbal Cleanse liquid directly from the manufacturer (It Works), and only had the Herbal Cleanse liquid for about 5 weeks or so. She said she did not see a UPC Number listed on the product packaging. She said she was using the Herbal Cleanse liquid as a kick start to weight loss. She said she had planned to take the Herbal Cleanse liquid over a 2-day period, taking one-4 oz. bottle before breakfast, and one-4 oz. bottle before dinner over two days. The outcome for event sore arm (pain in extremity) was unknown and outcome for limb discomfort was recovering. Follow-up attempts are needed. Further information is expected.
59 2021-06-01 pain in extremity She had Covid 19 virus symptoms; shortness of breath; heart is racing; chills; she feels her mouth a... Read more
She had Covid 19 virus symptoms; shortness of breath; heart is racing; chills; she feels her mouth as if she had eaten too much salt; diarrhea; Feet pain; This is a spontaneous report from a contactable consumer or other non-HCP. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0170), via an unspecified route of administration, administered on Left Arm on 14May2021 09:00 at single dose for covid-19 immunization (to protect herself from the virus). The patient's Medical history and concomitant medications were not reported. The Family Medical History Relevant to events was reported as none. The patient has not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172) via unspecified route of administration administered on Left Arm on 23Apr2021 for COVID-19 immunization. On 14May2021 14:00 the patient experienced shortness of breath, heart is racing, chills, she feels her mouth as if she had eaten too much salt, diarrhea, feet pain. Upon received follow-up information on 20May2021, it was reported that On 18May2021 the patient experienced She was told she had Covid 19 virus symptoms and if her symptoms persisted to keep treating herself at home. The doctor did not perform a Covid 19 virus test. It was reported that About 5 hours after receiving her second Covid 19 vaccine, the patient experienced the events. The events resulted in physician visit. The relevant tests was reported as none. The outcome of event she had covid 19 virus symptoms was unknown, while rest of events was not recovered. Follow up(20May2021): New Information received from the Pfizer colleague includes new adverse event details, anatomical location of both doses details. Follow up(20May2021): Upon follow up, no new information has been included. Information about Lot/Batch number is available. Further information is expected.
59 2021-06-02 pain in extremity Arm pain; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female p... Read more
Arm pain; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0167) at health department, via an unspecified route of administration, administered in left arm on 05May2021 at 13:05 (at the age of 59-year-old), as 1st dose, single dose for covid-19 immunisation. Reportedly, patient took second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0185) at health department via an unspecified route of administration, administered in left arm on 26May2021 at 13:05 (at the age of 59-years-old), as single dose for covid-19 immunisation. Patient was right-handed so she had them both in her left arm. Patient did not know a dosage for either dose. Patient thought it was good to have it. The patient medical history was none. The patient did not take any other products. The family medical history relevant to adverse events was none. No other vaccinations received by the patient within four weeks prior to the first administration date of the suspect vaccine. After the first dose of vaccination, the patient experienced arm pain on 05May2021. It started to hurt that evening (05May2021) and lasted probably for four days. The patient stated that with her first dose she had no other side effects. No relevant tests performed. There were no adverse events following prior vaccinations. There were no additional vaccines administered on same date with the Pfizer vaccine considered as suspect. The Patient did not visit emergency room and Physician office as well. No Investigation assessment or relevant tests were performed. This report was not related to a study or programme. The outcome of the event was resolved on an unspecified date in May2021. Information on Lot/Batch number was available. Additional information has been requested.
59 2021-06-02 pain in extremity runny nose; sneezing; sore arm; low grade fever; joint pain; tiredness; This is a spontaneous report... Read more
runny nose; sneezing; sore arm; low grade fever; joint pain; tiredness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in Arm Right on 23Apr2021 10:00 (at the age of 59-years-old), as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tiredness on 23Apr2021, and she had runny nose, sneezing and sore arm on an unspecified date and also experienced low grade fever, joint pain on 24Apr2021. The caller reports that she received her first vaccine dose on 23Apr2021. That night she started having mild symptoms which lasted through the weekend. Symptoms reported were sore arm, tiredness, achy joints, runny nose and sneezing. Caller reports that she took Tylenol and her symptoms improved but she reports that her problem is the achy joints have not gone away. Her second dose is due next week and she is concerned about getting the second dose concerned that her achy joints will not improve. The caller wanted to know this something that is going to continue and should she consider holding off on getting the second dose. The seriousness criteria of the events were reported as non-serious. Therapeutic measures were taken as a result of tiredness, runny nose, sneezing, low grade fever, joint pain and sore arm. The outcome of the events low grade fever resolved on 24Apr2021, tiredness resolved on 25Apr2021, runny nose, sneezing and sore arm resolving and for joint pain not resolved. No follow-up attempts are needed. No further information is expected.
59 2021-06-02 pain in extremity My left should and upper arm, started becoming sore and stiff the same evening I received the inject... Read more
My left should and upper arm, started becoming sore and stiff the same evening I received the injection which was on a Friday and by Sunday my arm was very painful and I could not move my arm in any direction. Dr. diagnosed it as being a frozen shoulder due to the injection being improperly administered. Currently going through 8 weeks of physical therapy and if my arm and shoulder haven't had significant improvement by the end of June, I may have to have surgery. Constant pain every day now for 3 months, can't sleep well as pain keeps me up at night, difficulty getting dressed and undressed, driving a car and doing my hair, can't lift anything and every time after therapy I suffer from severe pain for two to three days after.
59 2021-06-02 tremor, weakness, pain in extremity nausea added to all the symptoms above; Dizziness; chills; fever; severe ringing in ears; Burning un... Read more
nausea added to all the symptoms above; Dizziness; chills; fever; severe ringing in ears; Burning under skin above both elbows throughoutback shoulders and down back torsobut not along spinal bones; overall weakness and tiredness throughout body/unable to get out of bed; overall weakness and tiredness throughout body; Slight headache begins; feeling unwell; pain in left and moving up arm from injection site, across backshoulders, and down right are above elbow; shaky; This is a spontaneous report from a contactable consumer (patient). A 59-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246), an unspecified route of administration, administered in arm left on 04Mar2021 (at the age of 59-year-old) as a single dose for covid-19 immunisation at CDR. The patient medical history was reported as none. The patient concomitant medications were not reported. The patient previously took compazine [prochlorperazine maleate] and Zoloft and experienced drug allergies. The patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246) via unspecified route of administration in right arm on 11Feb2021at 02:00 PM as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccine in four week and not received any other medications in two weeks. On 04Mar2021 at 6:00 PM, patient experienced pain in left and moving up arm from injection site, across back shoulders, and down right are above elbow. 05Mar2021 at 10:00 AM, patient experienced burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones, overall weakness and tiredness throughout body, slight headache begins and feeling unwell. On 06Mar2021 at 8:00 AM, patient had dizziness and weakness, tiredness, severe/excruciating headache, muscle pain, chills, fever, feeling unwell, severe ringing in ears, unable to get out of bed. 06Mar2021 at 5:00 PM, nausea added to all symptoms above last 2 hours. 07Mar2021 at 8:00 AM, patient was able to get out of bed. On an unspecified date in Mar2021, patient was shaky. No relief from Advil pain reliever. Headache was manageable, dizziness persists, weakness/minimal energy, shaky, burning under skin remained. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
59 2021-06-03 weakness weak immediately after vaccine for several days, got better then started with temperature and chills... Read more
weak immediately after vaccine for several days, got better then started with temperature and chills and severe headache. Started to vomit and passed out, called the ambulance, went to ER, they stated it must be a really bad virus as they could not find anything wrong. Discharged from ER, remained weak over next few days but recovered
59 2021-06-03 weakness chills; Body Rash; No energy; Aches; This is a spontaneous report from a contactable consumer other ... Read more
chills; Body Rash; No energy; Aches; This is a spontaneous report from a contactable consumer other non HCP/ patient. A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via unspecified route of administration on 02Mar2021 at 13:00 (at the age of 59-year-old non-pregnant) as UNKNOWN, SINGLE DOSE for COVID-19 Immunisation. Medical history was reported as none and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient experienced Body rash, chills, aches, no energy on 04Mar2021 at 00:00 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse event included urgent care from dermatologist which included treatment with cream for rash and punch biopsy for back. Lab data included biopsy with unknown result on an unknown date. Clinical outcome of the events body rash, chills, aches, no energy was recovered. Information about lot/batch number cannot be obtained. No further information is expected. Amendment was made by DSU: This follow-up information is being submitted to amend previously reported information on Patient's first Name added, Age/Units captured as 59 years per event's onset "4Mar2021", Country added, Age at Vaccination updated from 60 to 59, For the reported event rash Treatment Received was captured as "yes' as per source dermatologist who did a punch biopsy and gave patient a cream for rash. Relevant Med History changed to None added since provided other medical history as none, removed Unknown from Lot# field, punch biopsy on back captured as lab data. Also, it was mentioned as Information about lot/batch number cannot be obtained. No further information is expected. updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained." Per SER055
59 2021-06-03 feeling cold On May 14th, 2021, the day of my 2nd Pfizer COVID-19 vaccine dose, I went to bed. I sneezed 6 times... Read more
On May 14th, 2021, the day of my 2nd Pfizer COVID-19 vaccine dose, I went to bed. I sneezed 6 times, hayfever related. I had a little too much sugar before bed and had a strong beating heart. I woke at 3am on May 15th, 2021 felling cold. Definitely cold, NOT chills. I felt "off", meaning that I was not experiencing the usual COVID-19 symptoms listed on eligible sources. I had a sore arm at the site of the vaccine. I took a hot shower, layered up and went back to bed to sleep, or doze. I had to get up at 5:30am. I felt better by 11am. Much improved by 3:00pm. I had heart arrhythmia for seconds between 11:00am-1:00pm. I had super and caffeine for breakfast. I have been consuming sugar and coffee together for years. No sugar and caffeine (coffee, chocolate) before bed on May 15th. No heart arrhythmia. Heart arrhythmia after combo M&Ms chocolate/peanuts. Sugar and caffeine seems to be a developed sensitivity to the point of getting heart arrhythmia.
59 2021-06-03 numbness, facial paralysis, bell's palsy Patient developed Bell's Palsy 2-3 weeks after receiving the 2nd vaccine. Patient reported symptoms ... Read more
Patient developed Bell's Palsy 2-3 weeks after receiving the 2nd vaccine. Patient reported symptoms that worsened on 4/17/2021. Patient was currently at work and could not feel her legs. She was able to walk but could not sense her legs. She presented to the ED on 4/17/2021 with bilateral leg numbness and left facial droop. After ED observation she had resolution of left facial droop and left leg weakness. Patient did leave against medical advice but stated she would follow up with her doctor.
59 2021-06-03 migraine headache/migraine which is typical with vaccinations like flu vaccine; headache/migraine which is ty... Read more
headache/migraine which is typical with vaccinations like flu vaccine; headache/migraine which is typical with vaccinations like flu vaccine; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6199, patient was not pregnant and 59-years-old at the time of vaccination), via an unspecified route of administration in Arm Left on 05Mar2021 at 15:45 as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient's medical history included allergies (known allergies: Yes). The patient's received unknown concomitant medication. On 05Mar2021 at 21:00, the patient experienced headache/migraine which is typical with vaccinations like flu vaccine. Facility type vaccine reported as other. Reported that patient not received other vaccine in four weeks. Reported that other medication was taken in two weeks but not reported any medicine. No treatment received for the event. Patient had not COVID prior vaccination and not tested covid post vaccination. The outcome of reported events was not recovered. No follow-up attempts are possible. No further information is expected.
59 2021-06-03 tingling Tingles, in her feet, toes, fingers, on the same side of her body as the shot, on her arm and tongue... Read more
Tingles, in her feet, toes, fingers, on the same side of her body as the shot, on her arm and tongue; sleepy; she felt woozy/Lightheadedness; Tiredness; This is a spontaneous report from a contactable consumer(patient). A 59-year-old female patient received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 06Apr2021 09:00 (age at vaccination 59) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included ongoing high blood pressure, ongoing high cholesterol, her cholesterol may have been a little high, for years, from her 20 or 30 and then it balanced out, or improved. she has no history of Diabetes or Carpal Tunnel Syndrome. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for high blood pressure from an unspecified start date and ongoing; diltiazem (DILTIAZEM) taken for high blood pressure from an unspecified start date and ongoing; atorvastatin (ATORVASTATIN) taken for high cholesterol from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for high blood pressure from an unspecified start date and ongoing. Patient was not administered any additional vaccines on same day of vaccination. The patient previously took tetanus vaccine for tetanus and experienced injection site swelling and experienced erythema (red, was swollen and painful, with a red circle). Patient was not received any other vaccine prior four weeks of vaccination. On 06Apr2021 the patient experienced tingles, in her feet, toes, fingers, on the same side of her body as the shot, on her arm and tongue, sleepy, tiredness and she felt woozy/light-headedness. Patient not visited to Emergency Room and Physician Office for the events. Clinical information included: she has extended the time to take her second shot so she can speak to her doctor about the side effects that she had, after the shot, she felt woozy, lightheaded, and tired. Caller reclarifies these descriptors later in report. At night, she started to feel tingles, in her feet, toes, fingers, on the same side of her body as the shot, on her arm and tongue. She did not tell anyone or let them know, and then fell asleep. She felt the effects until the next morning and they went away and did not come back. She did not tell her family, until it was time to get the second vaccination. She did speak to her doctor and the doctor felt it was some type of reaction. Caller states the doctor recommended that she take two Benadryl and two Tylenol, when she goes for the second vaccination. Caller states she will not have any side effects, because she will not be awake to know, because both of those medications might make her sleepy. Reclarified later in report. She spoke with a health nurse, who thought that she had some type of reaction, to the vaccine. Caller states the nurse did tell her that her immune system could be elevated and wanted her to check with her doctor. The nurse told her she does have some coverage, from the virus, with the first vaccine. Caller states that last week she had another doctor appointment, and the doctor told her that if she had a reaction with the first vaccine, she would probably have a reaction with the second vaccine. The doctor told her that if she does not take the second dose, she cannot be around other people and will be restricted, according to the guidelines. She had rescheduled her vaccine for Thursday, but pushed it out until next week, so she could take a day off from her job to recover, if needed. She wanted to report, her events. She is sceptical, to take the second vaccine, and she states she wants to take it, but does not want to put herself at risk. Caller states, reclarified, that she knows a few people that also had tingles. Caller cannot provide specifics about these people. Caller identifies one person as a female who had a tingle in her throat. Caller states she cannot provide specific details. Caller reclarifies that she is calling about the Pfizer Covid 19 vaccine. Caller reclarifies that she never took the Benadryl or Tylenol after her vaccine, and states that she did not have a reaction to these medications. Caller confirms these events are after the first vaccine. Her description of light-headedness, was really tiredness, and describes the tiredness as woozy and sleepy. Start: caller answers as the same date of her first shot. Caller states she left her vaccine card in the car. Caller later reclarifies the date as 06Apr2021. caller states her vaccine appointment was at 9 am and she felt the effects in the first 15 minutes after the vaccine tingles, in her feet, toes, fingers, on the same side of her body as the shot, on her arm and tongue. Caller states two of her medications were at one time one pill, and because of the cost, her doctor gave her two separate medications. The outcome of the event was reported as recovered on 07-APR-2021. Follow up attempts needed. Further information is expected.
59 2021-06-06 discomfort Three days after receiving the first dose, I woke to significant joint pain and stiffness. It was e... Read more
Three days after receiving the first dose, I woke to significant joint pain and stiffness. It was extrmely difficult to move around as well as ascend and descend stairs and transition from sit <->stand without great effort. Pain and discomfort was so high that I often felt extreme fatigue going up/down 1 flight of stairs. These adverse events lasted for at least 3 weeks post my second vaccination. 4/3/21 PCP visit for knee pain (R>L) xrays taken referred to Sports Medicine 3/9/2021 visit to Sports Medicine more xrays and ultrasound referred to Rheumatology 4/9/2021 Rheumatology full exam (to rule out rheumatoid arthritis(?) then additional bloodwork) 5/3/2021 Gastronterology appointment (in flare) prescribed steriod and suppository 5/28/2021 Emergency Department visit per direction of GI's office prescribed tapered course of steriods (Prednisone) and antibiotic (Flagyl)
59 2021-06-06 nerve pain, muscle spasms severe nerve pain in my left leg hamstring area and top of my left foot. After 2nd vaccine, severe... Read more
severe nerve pain in my left leg hamstring area and top of my left foot. After 2nd vaccine, severe nerve, hip pain which caused me to limp for 5 days. Severe uterus pains. Severe foot cramping which knarled my toes and lasted for 8 hours straight. Groin pain on both sides. Whenever I get these pains, I feel the injection site muscle tingling.
59 2021-06-07 migraine a bad headache/headaches are cyclical; migraines; This is a spontaneous report from a contactable co... Read more
a bad headache/headaches are cyclical; migraines; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EW0172), dose 2 via an unspecified route of administration in left arm on 27Apr2021 15:00 at age of 59 years old as single dose for covid-19 immunisation (prevent Covid 19 virus). Medical history included migraine from 2020 and ongoing (She was diagnosed around this time last year in 2020. She had migraines undiagnosed prior. Her migraines were well controlled). The patient's concomitant medications reported as she's been taking her regular medication like normal. Most of her medications she's been taking for years. Even the migraine medication was not a new medication. The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EW0150), via an unspecified route of administration in left arm on 06Apr2021 15:00 at age of 59 years old as single dose for covid-19 immunisation and did get headaches during that week with the first Covid 19 vaccine but her headaches resolved.There were no additional vaccines administered on same date of the Pfizer suspect. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She received the second Covid 19 vaccine on 27Apr2021 and she started getting bad headaches probably the next day on 28Apr2021 and the headaches just keep going on. They were pretty much staying the same. The headaches did get better with medication. She's fine in the morning but by lunchtime she had a full blown headache. She said it's positional. It was getting better when she's laying down but she's also taking medication so she didn't know if the laying down was helping or the medication was helping. Her headaches were very cyclical. She had seen a neurologist several times but not getting any relief that way, and went to the emergency department yesterday, 19May2021. The doctor was thinking it's migraines but it's not going away. She's wondering if it's a side effect of the Covid 19 vaccine. Her doctor had ruled out everything with her brain, she didn't have the Covid 19 virus, and she's also had blood work drawn that was ok. She was in contact with her neurologist on 05May2021 or 06May2021. She was seen by her neurologist on 10May2021, 11May2021, and 17May2021. Her neurologist instructed her to go to the emergency room yesterday, on 19May2021. She had a CT scan of her head done yesterday 19May2021 and blood work. At her neurologists office she had an injection in her skull. She didn't know the name of the medication used. She was given a cocktail of generic Toradol, Benadryl, and Zofran. She's taking Tylenol, Excedrin, Sumatriptan, Nurtec, and Reyvow. She was given other medications in the hospital but she's not sure what medications she received. She did not feel her medications were relevant. The events required a visit to emergency room and physician office. The patient underwent lab tests and procedures which included blood test on 19May2021, computerised tomogram: negative on 19May2021. The outcome of events was not recovered.
59 2021-06-07 pain in extremity, hot flush, feeling hot Feels hot but has no temperature/ She feels like warm; She was having a hot flash; Fever/ temperatur... Read more
Feels hot but has no temperature/ She feels like warm; She was having a hot flash; Fever/ temperature was very high/ last night her temperature was 101.8/ high fevers like 101.2 in the morning and then in the afternoon it was 101.3, then in the evening it was 101.8.; Chills; Joint pain; Tiredness; Terrible headache; Muscle pain; Nauseated; Skin kind of hurt; Muscle pain in her arm where they gave her the injection; Yesterday in the shower she couldn't lift her arm; After the injection she staarted to hurt; Arm pain; This is a spontaneous report from a contactable consumer (patient, self-reported). A 59-year-old female patient (age at vaccination: 59 year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0185 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 26May2021 at 13:05, as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0167 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05May2021, as a single dose for COVID-19 immunization and had arm pain which was started to hurt that evening. It lasted probably 4 days. The patient took Pfizer COVID Second Shot because She didn't want the COVID. The patient's medical history and concomitant medications were not reported. The family medical history of the patient related to AE is reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 26May2021, after the injection she started to hurt which included arm pain. On 27May2021, she experienced tiredness, terrible headache which was getting better. Yesterday it was horrible. She thought when she had a high fever, she got a headache. It was over on the left side of her head over her left eye. She took Advil yesterday morning at 07:00 and then Tylenol at 14:20 and then back to Advil. She had no NDC, lot, or expiration date available for the Advil or the Tylenol. They were both upstairs. She had muscle pain in her arm where they gave her the injection which was still sore. Yesterday in the shower she couldn't lift her arm. She thought it was slowly getting a little better. She woke up at 03:00 yesterday with chills. That has passed. It was completely gone now. She had joint pain which was also passed and was gone. She had fever with temperature was 101.8. Today she felt like she was nauseated this morning, but it seems to slowly be going away and which was getting better. Everything started yesterday. She had her second shot on Wednesday. With her first shot she had no side effects, just after the second shot she started having all the side effects. She had a headache this morning and took another Advil. She felt nauseous this morning, but she thought it was slowly passing. She feels hot but has no temperature today. She took her temperature, and it was normal, but she felt hot like she was having a hot flash. She feels like warm. Yesterday she was really hot with high fevers like 101.2 in the morning and then in the afternoon it was 101.3, then in the evening it was 101.8. It was even like her skin kind of hurt when she touched it. That has gone away too. On 28May2021, she felt hot but has no temperature/ She felt like warm which was just started today. She felt like hot now and then. When asked if it has improved, worsened, or is persisting, she stated when she went outside, she felt better, and when she came inside the house, she felt hot. She was right-handed so she had them both in her left arm. She did not know a dosage for either dose. It was provided by the Health Department. She had a lot of side effects yesterday after she received the shot. She didn't know if a lot of people had called. She asked if this was the right place to report her side effects too. Outcome of the events tiredness, chills, joint pain, Skin kind of hurt was recovered on 27May2021. Outcome of the events terrible headache, muscle pain, nauseated, arm pain, muscle pain in her arm where they gave her the injection, yesterday in the shower she couldn't lift her arm was recovering and for all other events, it was unknown.
59 2021-06-07 pain in extremity I got a really really bad severe case of vertigo; Nausea; Dizziness; Headache; Fatigue; My backache ... Read more
I got a really really bad severe case of vertigo; Nausea; Dizziness; Headache; Fatigue; My backache that problem have like tripled it got much much worse since I got the shot you know like the muscle ache you know my arm hurt really bad; My backache that problem have like tripled it got much much worse since I got the shot you know like the muscle ache you know my arm hurt really bad; My backache that problem have like tripled it got much much worse since I got the shot you know like the muscle ache you know my arm hurt really bad; I didn't feel good; I couldn't eat, couldn't walk, couldn't get myself once a dinner; I couldn't eat, couldn't walk, couldn't get myself once a dinner; Abdominal discomfort; I couldn't eat, couldn't walk, couldn't get myself once a dinner; This is a spontaneous report received from a contactable consumer (the patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EW0187, Expiration date: not reported) via an unspecified route of administration in left arm on 24May2021 (Monday) (at the age of 59 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history included Asthma, Head trauma, Had car accidents, Allergies from on unknown date and unknown if ongoing. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for Asthma and loratadine (CLARIDIN) taken for Allergies on daily, start and stop date were not reported. On 27May2021, Patient stated that got a really really bad severe case of vertigo yesterday which was like what 72 hours after the shot, I got it on monday and it happened yesterday so I woke up with it like actually like really bad nausea and severe vertigo and I still have it and you know I can't get to a doctor to get it or therapist to get it treated because they don't have any availability but I tried to doing head movement myself but I haven't really had any relief. Consumer stated, when I got vertigo it can take weeks for it to go away. Unless I can get treatment from a therapist who specializes and then she was not available then I can suffer for weeks so three weeks from now you know If we gonna get severe dizziness and vertigo that's gonna really distrust people from gonna go and get the second one. I went for my shot at noon time on Monday and then on Thursday, 27May I woke up with really upset stomach which is typical in vertigo. So, I got severe vertigo exactly 3 days later so a little bit less than 24, 48 a little bit less than whatever it is 72 hours later. Consumer stated, Yeah but you know what else I got within 5 minutes of getting the shot I started getting the horrible headache and then It just got progressively worse. I mean my asthma so you know I have like a lousy immune system (further not clarified) so I think I'm more prone to having side effects but I didn't realize it was gonna be that bad also so on the 24 within 5 minutes of getting it. I've started getting wild headache and then horrible headache and I took Motrin for like 24 hours(treatment) and it didn't even help the headache not one single bit. It was so like my head was like in a vice like someone was squeezing it in a vice that's how severe it was like to disabling. On May2021, I couldn't eat, couldn't walk, couldn't get myself once a dinner or anything. It was terrible that's how bad it was so and then you know the nausea started immediately so a mild upset stomach on May2021 for about 48 hours and then the third day it was much much more worse because of the vertigo so it was severe headache all over. It was horrible, it felt like someone was hitting the head with sludge hammer and the dizziness started immediately on 24May2021, the headache started immediately on 24May2021 and the extreme fatigue on 24May2021 that haven't gone away since I got it. So I don't know what you need to write down but that's it. Those are side effect. and then I take on a daily basis for my bad back I mean I have really really bad back on 24May2021, so I've actually my backache seems to when I took Motrin(treatment) obviously but my backache that problem have like tripled it got much much worse since I got the shot you know like the muscle ache you know my arm hurt really bad for 48 hours the minute it stopped, but my bad back has been horrible since I got the shot because its been much much worse and like I said I haven't done anything to exacerbate so. Then the vertigo started 3 days, little bit less than 3 days later I woke up with it horrible vertigo pretty severe. It was slightly better today, well it was earlier but the more I move around so since I got the shot 4 days ago the more I move around the more I do whether its like doing laundry getting lunch or whatever like the dizziness will just come back like full force. If I try to sit and rest and don't leave and only watch TV it stabilizes a little bit but yeah the dizziness I've talked to a lot of people and they've all had the side effect not just from the shot I got but from the other shots as well. So, Its crazy. Consumer stated that I don't know, I will try to go back in the couple of weeks. So, whatever date that is, 14 may be. On 14Jun2021 I'm gonna try to go back. These are the 14 or 15 but they just told to come back in 3 weeks afterwards so that's what I'm gonna do. Medical Condition was reported as so I have you know thin fever but I don't have any other issue the only thing I have is asthma you know all my doctor saying Oh you have asthma so you should really get it so like an idiot If I had known I was gonna have this horrible you know side effect the first time I never would have getting it first place so you know that all these people would these horrible side effects are saying screw it we are not gonna get back for second shot you know who wants to suffer like this again its been an entire week and I'm not any better than I was on Monday So, you know the headache is better the upset stomach is better but the dizziness I can deal with the headache and the upset stomach but the vertigo, if you have ever experienced it. It is pure hell because you know you can't lay down and sleep you can't and I live alone so that's really scary you know what I'm saying. I can't get anything to eat. I can't go out. I can't drive when I get vertigo but I do have a history of it. I think the last time I had it might've been like February or March maybe when I get treated for it you know but I haven't done anything at all to set it off. I haven't been doing any heavy lifting or heavy cleaning or bending or whatever which sometimes sets it off. So, I'm just you know been resting since Monday. I haven't done anything or left the house. The outcome of the events she got a really really bad severe case of vertigo, nausea was not recovered and other events were reported as unknown. Information on Lot/Batch number was available. Additional information has been requested.
59 2021-06-08 slurring, bell's palsy I developed Belle Palsy after receiving the vaccine. I had very similar symptoms to having a stroke... Read more
I developed Belle Palsy after receiving the vaccine. I had very similar symptoms to having a stroke. I have a droopy mouth, slurred speech, I couldn't blink my eye. I had a reaction to the steroid that was given to treat my Belle Palsy diagnosis from the ER visit. I also experience horrible headaches. And hearing issues in the effect side.
59 2021-06-08 feeling hot After about 15 to 16 days, patient reported hives/rash that are round in shape with sharp clear bord... Read more
After about 15 to 16 days, patient reported hives/rash that are round in shape with sharp clear borders. Initially light red in color, turned red then dark red, then faded with border becoming more diffuse. Rash occurs on right thigh and back of right arm. The rash feels hot, a feeling of heat, like she was touching a hot burner. Vaccine was administered on right deltoid. Severe insomnia, could not sleep at all. Headaches. Today 6/9/2021 the rash appears to have subsided, became more diffuse and lighter but still there.
59 2021-06-08 pain in extremity, migraine This is a spontaneous report form the contactable consumer (patient). A 59-year-old female patient r... Read more
This is a spontaneous report form the contactable consumer (patient). A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, NDC number and Expiry Date: Unknown) via an unspecified route of administration in left arm on 16Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included autoimmune disorder (diagnosed 35 years ago) and has not been experiencing any symptoms from that just some very minor symptoms very recently. Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Patient had previously received first dose of vaccine (Lot no: EP7534) on 26Mar2021 and had left arm swelling (injection arm) and pain, along with migraines and fatigue which resolved after a week. Immediately the same day as the 2nd dose of the vaccine, the patient had pain in her left (injection) arm/hurting and restricted movement in her left arm. On an unspecified date (after the second dose), patient was extremely tired, very fatigued and had migraines along with pain and swelling in her left (injection) arm. The pain in her arm continued for about 6 weeks. Patient did not remember what got better and what got worse and forgot about it, but the pain never went away. The swelling got better but was not as bad. No treatment was received for the events. Events did not require visit to emergency room or physician office. The outcome of events pain in her left (injection) arm was swelling and hurting and restricted movement in this arm was not resolved while for other events fatigue and migraine was unknown. Additional information has been requested.; Sender's Comments: Agent, caller is a consumer that reported her side effects after receipt of both doses of Pfizer COVID vaccine, however her question is if she can get further clarification if possible, regarding if she should go have quantitative antibody testing that will tell her if she is protected or not? caller was warm transferred by Agent and caller stated "I got information that I did not understand", caller asked: "How do I know if my second dose worked if I had this side effects?. E-transmitted duplicate AE, caller did not provide additional AE details Response: Responded per documents attached and referred for discussion. Offered to send PRD by email, but caller declined and stated her HCP will have that information. Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller stated from prior INT: "I got information that I did not understand" Caller stated she also did not understand information provided by Agent during this follow-up INT. Response: Referred back to her HCP for specific recommendations and medical advice regarding antibody testing, and offered to email the PRD from response provided in prior Request and Interaction, but caller declined and stated her HCP will have that information.
59 2021-06-08 pain in extremity The next day after vaccine on 04/13/2021 I was lethargic. I drank lots of liquids. I was very tired ... Read more
The next day after vaccine on 04/13/2021 I was lethargic. I drank lots of liquids. I was very tired with a headache, nausea, chills (very slight). 04/15/2021 I woke up in the middle of night and it felt like the nerves in my body were exposed and the next day I didn't have that pain anymore but I was still very lethargic. Nausea went away pretty quickly. The 2nd week after vaccine, I had the same pain but in my upper thigh and wrist. The following week I ended up with shingles. I did go to the Doctor that diagnosed me with shingles. 2 weeks after I noticed a thick red band on my mouth towards my neck. I started on antiviral medications that the Doctor prescribed me.
59 2021-06-08 pain in extremity Had limited functionality in that arm now/A couple hours after the vaccine she couldn't move it at a... Read more
Had limited functionality in that arm now/A couple hours after the vaccine she couldn't move it at all; Arm has been messed up; She can pinpoint the exact location, because that is where it hurts the most; It hurts all the time/her whole left arm hurts; This is a spontaneous report from contactable nurse (patient). A 59-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284) via an unspecified route of administration, administered into left arm on 12Jan2021 (at the age of 59-year-old) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685) administered into right arm on 22Dec2020 (at the age of 59-year-old) for COVID-19 immunization. It was reported that patient received the second dose of the vaccine on 12Jan2021 and has had limited functionality in that arm now; it was further reported that a couple hours after the vaccine she couldn't move it at all. It was also reported that her arm has been messed up since 12Jan2021. The patient can show people exactly where her shot was given, she can pinpoint the exact location, because that is where it hurts the most, but now her whole left arm hurts it hurts all the time. The events had limited functionality in that arm now/a couple hours after the vaccine she couldn't move it at all and arm has been messed up was reported as serious, medically significant. The patient received treatment for the events reported, she took Tylenol. Outcome of event arm has been messed up was not recovered while the outcome of all other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported vaccination site movement impairment and limb discomfort. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-06-08 tenderness tired; lethargic; blisters started to developed; itchiness and pins around rash area.; She was tende... Read more
tired; lethargic; blisters started to developed; itchiness and pins around rash area.; She was tender to touch in those area; parts of her body were inflamed; Severe case of shingles; Sore at injection site; Body aches in major muscle areas-upper arms, waist, mid chest, mid back and thighs.; Body aches in major muscle areas-upper arms, waist, mid chest, mid back and thighs/It started with body aches. The aches started around the injection site then she started getting body aches over the entire body in major muscle groups areas; a rash started to develop under my right breast and spread from mid chest in a 2" band width around 1/2 of my body, under my right arm to mid back/Then it progressed to a rash; stuffy nose; dry cough; It hurt to breath/she had a hard time breathing; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: FEP7533, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 06Apr2021 15:30 (at the age of 59-year-old) as 1st dose, single for covid-19 immunisation administered at hospital. Medical history included ligament operation (Perfect health other than 2 ACL replacements due to skiing injuries), non-tobacco user (Dont smoke), do drugs and drink in moderation. List of any other medications the patient received within 2 weeks of vaccination included Calcium Gummies, Glucosamine HCI, D3, nails gummie. The patient does not have any Allergies to medications, food, or other products. No other vaccine received in four weeks. Patient is not pregnant at the time of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. On 07Apr2021 03:30 PM the patient experienced, Severe case of shingles. Started of as what I thought were side effects of the vaccine. Sore at injection site. Body aches in major muscle areas-upper arms, waist, mid chest, mid back and thighs. Pain intensified over second day, a rash started to develop under my right breast and spread from mid chest in a 2 band width around 1/2 of my body, under my right arm to mid back. Had a stuffy nose and tickle at the back of my throat that triggered a dry cough. It hurt to breath but was able to get air. When pustules started to develop 4 days after the vaccine guessed it might be shingles and went to Urgent Care at (withheld). Major soreness was gone 3 days after vaccine but the afore mentioned body parts remained tender to the touch for 4-5 days and on day 6-7 turned to itchy/pins stuck in my skin sensation around the rash area that are still present today. I AM concerned that my second shot scheduled for 29Apr2021 will develop into a second case of shingles. please advise. She had two numbers to call from when she got her COVID19 Vaccine. She only had her first dose. She did the self reporting tool. She developed Shingles exactly 24 hours after she received the shot. It seems coincidental. She went to urgent care. When it got worse she had to go to Urgent Care because it was a Friday night and her GP was not available. She went to her facility's Urgent Care in (withheld). It wasn't a fly by night urgent care. It was very good and they reported it to her doctor. They had her medical records there. She thought it was side effects from the vaccine. She got the vaccines on the sixth. It started with the aches. Caller clarified that she reported this previously on Pfizer safety reporting online. It started with body aches. The aches started around the injection site then she started getting body aches over the entire body in major muscle groups areas. Then it progressed to a rash. She thought it was a side effect. It's harder on women than men. She was tender to touch in those area. She had a dry cough. Stuffy nose, there was no dripping. She was tired and lethargic. It was nothing major. She was able to go out and do stuff. On day two, so it was 24 hours after, she had a hard time breathing. It wasn't like she had trouble getting a breath but it hurt to breathe. Her doctor said that because of shingles parts of her body were inflamed and due to inflammation it hurt to take a breath. She didn't feel short of breath, but it was painful to breathe. After about 4 to 5 days the rash got worse and blisters started to developed. The body aches went away and were replaced by itchiness and pins around rash area. Her concern is because it was the first shot and she is going into day 16 and has another one scheduled for the 29th. Is shingles a common side effect? Does she take a risk of getting the second dose of the COVID vaccine or will it intensify what currently hasn't gone away yet? She wants to know what is the effect of the second dose on an existing side effect that was experienced after first dose. Patient received 1gram of valacyclovir, 3 times a day for 7 days as treatment for the adverse events. Therapeutic measures were taken as a result of severe case of shingles, sore at injection site, body aches in major muscle areas-upper arms, waist, mid chest, mid back and thighs, body aches in major muscle areas-upper arms, waist, mid chest, mid back and thighs, a rash started to develop under my right breast and spread from mid chest in a 2 band width around 1/2 of my body, under my right arm to mid back, stuffy nose, dry cough. The outcome for the events severe case of shingles, sore at injection site, body aches in major muscle areas-upper arms, waist, mid chest, mid back and thighs, a rash started to develop under my right breast and spread from mid chest in a 2 band width around 1/2 of my body, under my right arm to mid back, stuffy nose, dry cough, it hurt to breath, tired was resolving and unknown for other events. No follow-up attempts are needed. No further information is expected.
59 2021-06-09 nerve injury developed tinnitus in both ears
59 2021-06-09 throat numbness at 25 minutes after injection, left side of my throat felt numb; Red rash developed on right throat ... Read more
at 25 minutes after injection, left side of my throat felt numb; Red rash developed on right throat andspread to chest and left side of throat; Agitated; Shaky; Hard toswallow; Blood pressure went highover 200; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on the right arm on 15Mar2021 at 14:00 (at the age of 59-year-old), as single dose for COVID-19 immunisation. Medical history included hypothyroidism, high blood pressure, kidney cancer. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included lisinopril, levothyroxine, milk thistle. Past drug included penicillin for which patient developed allergy. On 15Mar2021 at 14:25, after 25 minutes of vaccination, the patient's left side of the throat felt numb, then a red rash developed on right throat, spread to chest and then to left side of throat, then patient felt agitated, shaky, was unable to swallow and blood pressure went high over 200. After about 30 minutes events started to reverse. It was unknown whether the patient received treatment for the events. The clinical outcome of events numbness throat, red rash, agitated, shaky feeling, unable to swallow and blood pressure went high was resolved in Mar2021. Information about lot number cannot be obtained. No further information is expected.
59 2021-06-10 feeling hot Pain, warmth, swelling for > 2 weeks. Peeling skin, loss of pigmentation of skin
59 2021-06-10 nerve injury Permanent disfigurement of my muscles; it's like my arm is sunken where they gave me the shot; perma... Read more
Permanent disfigurement of my muscles; it's like my arm is sunken where they gave me the shot; permanent disfigurement of her 'nerve' and her muscles; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 59-years-old female patient received BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Lot Number: EL1284; Expiration Date: Apr2021), via intramuscular route of administration in left arm on 27Jan2021 (vaccination at the age of 59-year-old) as unknown, single dose for covid-19 immunisation. Medical history included allergy from an unknown date and unknown if ongoing. Concomitantly patient was taking allergy pills (Singulair, I think I do not know). Patient had not received any other vaccination within 4weeks. On 27Jan2021, almost immediately same day, the patient experienced permanent disfigurement of her muscles, it was like her arm was sunken where they gave her the shot. Patient reported that she got vaccine in Jan2021 and had permanent disfigurement of her 'nerve' and her muscles. Patient asked if it was part of side effect and had it happened to anyone else. No treatment was taken for the event, as patient stated that nobody knows what it was. They had not seen this before. Reporter seriousness was unspecified. No investigation assessment was done. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
59 2021-06-12 burning sensation, discomfort Reaction after Dose 2: Extreme dryness did not star until about 5 day after the 2nd shot. My tongues... Read more
Reaction after Dose 2: Extreme dryness did not star until about 5 day after the 2nd shot. My tongues swelled to level of extreme discomfort. Over the next week the dryness, burins continues to get worse and worse. Reaction After Dose 1: Extreme dry mouth, eye, crusty eyes, burning sensation in my mouth, swollen and inflamed tongue. An extreme Sojren's flare that was confirmed by positive antibodies result for m"Early Sojren's antibodies. I had never had those symptoms before the vaccine. The dry mouth happened with an hour of receiving the first shot. One week later it exploded.
59 2021-06-13 migraine Upon receiving my first vaccine for COVID-19 on April 1, I experienced moderate fatigue and an unrem... Read more
Upon receiving my first vaccine for COVID-19 on April 1, I experienced moderate fatigue and an unremarkable headache for the first few days, no Fever. On April 5, I awoke with nausea that is extremely unusual for me, and it lasted until bedtime. On April 6, I awoke to a painful, debilitating migraine, worse than most migraines that I have experienced. During the 71 days now since my first vaccine, I have experienced similarly debilitating migraines with headache pain, difficulty concentrating, moderate to extreme sensitivity to light and sound, and slowed functioning on at least 45 of those days. Dizziness or vertigo like sensation is present on many of those headache days, and sometimes on intervening days as well. Typically the intervening days between isolated migraine events are no more than 1-3 days, but I did have about a week of much better days after a magnesium and Toradol infusion in my doctor's office. I did also have an infusion of the same ingredients, and also Reglan and a small amount of DHE followed by a pill of Decadron in the emergency room about two weeks later and experienced no more than 3 days before the debilitating migraines began again. It is important to note that while I have experienced migraines much of my life, I have never had such frequent and debilitating headache pain and migraine symptoms. The frequency of migraines is usually no more than a couple a month and often I go some months with no symptoms Treatment is ongoing with a new neurologist, modifying and severely limiting meds to abort migraines, considering options for prophylaxis and other prevention methods. A third infusion scheduled for this week as well, looking forward to some relief from current migraine, and a break in the pain. Osteopathic massage, acupuncture (magnet therapy for stiff neck, migraines) are alternative treatments that lessen the impact of my symptoms a bit. Scheduled consultation regarding migraine frequency and severity in July. It is remarkable to note one additional Neurological symptom that I have experienced during this time period since the vaccine - esumption of my Thoracic Outlet Syndrome pain that had not been a problem at my current level in many years. That pain includes symptoms of both bilateral epicondylitis and bilateral carpal tunnel syndrome which are both pretty constant now, burning sensation, occassional stiffness, general constant pain. New physician appointment for treatment for returned Thoracic Outlet syndrome. I am also seeing my primary care and holistic MDs regularly to monitor my progress and seek additional care and oversight for these events that have turned my life upside down. I am struggling with managing the construction of our new home, managing my medical care, and again having to delay pursuing new employment after staying home raising our two sons all these year. Fortunate that I have an adult son at home this summer who can drive me to all of my medical appointments and treatments. The costs are beginning to add up for all expenses that are either uncovered by insurance or have high deductibles, and I am having difficulty making payments for this care. I am of course thankful that I am prevented from catching COVID-19, but concerned that these neurological symptoms of intractable migraines, dizziness and arm pain may be here to stay as long as I am receiving vaccine boosters. Is this a manageable status quo for life? I am hopeful that the CDC, or Pfizer can help me out with both my expenses, and most importantly a cure for my ailments that I am very suspicious was caused by the vaccine.
59 2021-06-13 pain in extremity Started 3 days after second vaccine, Severe paid in all of hand joints, all of feet joints, knees, ... Read more
Started 3 days after second vaccine, Severe paid in all of hand joints, all of feet joints, knees, Lumps showing up on finger joints, fuzzy head (NOW 6 WEEKS) and still CONTINUES - Went to Clinic - Went to ER - Went to Family Doctor ***NO Relief Found
59 2021-06-14 weakness, pain in extremity, feeling hot sore arm, unable to lift arm it has been 2 months now. Heat in arm. Painful especially when turning ... Read more
sore arm, unable to lift arm it has been 2 months now. Heat in arm. Painful especially when turning arm, wakes me up at night. No strength in arm.
59 2021-06-14 cold sweat Within 24 hrs I got the chills and headache. By 2 am 6/14/2021, I was woken up with cold sweats and ... Read more
Within 24 hrs I got the chills and headache. By 2 am 6/14/2021, I was woken up with cold sweats and abdominal pain with some vomiting. 6/15/2021 I have mild headache.
59 2021-06-14 tingling, discomfort, numbness About 5 days after my vaccine I also experienced numbness and tingling that was so painful that I we... Read more
About 5 days after my vaccine I also experienced numbness and tingling that was so painful that I went to see my DR. She said she had heard of this other times and that it could last as long as six months. It is still happening now to me, it is ongoing and very uncomfortable but not as bad as it was initially. The DR did not give any medication. I take tramadol and cyclobenzaprine for chronic back pain so I take that occasionally and probably helps with this ongoing issue.
59 2021-06-14 tenderness, pain in extremity It started in my right thumb in the joint it started swelling and I could bend it. The pad part of m... Read more
It started in my right thumb in the joint it started swelling and I could bend it. The pad part of my hand was very tender. My doctor said that it may be trigger thumb caused by Tendonitis. About two weeks ago I began to have the same pain in the left hand and the same symptoms. I was offer the same treatment but I didn't take it because the first shot hurt so bad. The doctor said that if it is unusual to have the same thing in both hands. He don't think it is related to the Pfizer vaccine but I do. (Participant) I am still having trouble with both hands hurting.
59 2021-06-15 pain in extremity Extreme fatigue; sore throat; stomach pain; sore arm; chills; This is a spontaneous report from a co... Read more
Extreme fatigue; sore throat; stomach pain; sore arm; chills; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 15:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . Medical history included rheumatoid arthritis , covid-19 from an unknown date prior vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced hypersensitivity. The patient experienced extreme fatigue on 11Mar2021 14:30 with outcome of recovering , sore throat on 11Mar2021 14:30 with outcome of recovering , stomach pain on 11Mar2021 14:30 with outcome of recovering , sore arm on 11Mar2021 14:30 with outcome of recovering , chills on 11Mar2021 14:30 with outcome of recovering. The patient underwent lab tests and procedures which included blood test: negative on 26Aug2020 , sars-cov-2 test: negative on 10Mar2021 . No follow-up attempts are possible; information about lot/batch number cannot been obtained.
59 2021-06-16 breast pain Pain in left breast near armpit; Suspect swollen lymph nodes; This is a spontaneous report received ... Read more
Pain in left breast near armpit; Suspect swollen lymph nodes; This is a spontaneous report received from a contactable consumer. An 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206, Dose number: 2) via unknown route of administration on the left arm on 16Mar2021 at 11:15 hours as a single first dose for COVID-19 immunisation. The patient's past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW6198) via an unspecified route of administration on 24Feb2021 at 15:15 hours as single first dose for COVID-19 immunisation. Medical history included arthritis. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ZYRTEC, Rousuvastatin (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), XHANCE for an unknown indication since an unspecified date and was unknown if ongoing. On 17Mar2021 at 7:00 hours, the patient experienced pain in left breast near armpit. The pain was still present 2 days after the vaccine. The patient suspected it was swollen lymph nodes but the patient was concerned about another cause and was concerned it would persist. The clinical outcome of the events pain in left breast near armpit and suspect swollen lymph nodes was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
59 2021-06-16 pain in extremity mark on her arm/"divit" in her arm; mark on her arm/"divit" in her arm and pain/The pain is getting ... Read more
mark on her arm/"divit" in her arm; mark on her arm/"divit" in her arm and pain/The pain is getting worse; Is an indentation, like a divet, in the arm at the injection site; arm pain; everything is tanning except for that spot on left arm; crying; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1284; Expiration Date: Apr2021), via an unspecified route of administration, administered in left arm on 27Jan2021 10:30 as 1st dose, single dose(at the age of 59-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No history previous immunizations, and vaccinations within 4weeks. The patient experienced mark on arm, is an indentation, like a divet, in the left arm at the injection site and reported the mark was for a week or two after; and had arm pain, this is the same arm where the pain is. Patient started to get tan and everything is tanning except for that spot on her left arm. The pain has been worse, It hurts her so bad she wakes up in pain crying. In her opinion, the divot looks like it is getting bigger. Patient reported she visited to emergency room or physician office, and also reported she had a bloodwork but that was after and in opposite arm, in the right arm not the left and mammogram done last month. Patient refused to take the second dose of vaccination. The outcome of events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
59 2021-06-16 pain in extremity MY arm is a tad swollen; It kinda hurt. It doesn't hurt unless I lay or press on it/Arm was aching a... Read more
MY arm is a tad swollen; It kinda hurt. It doesn't hurt unless I lay or press on it/Arm was aching a little bit; headache; was actually worried of getting the shot because I am on 3 different main pill (Unspecified medications) that I take every day and now I have not taken them; This is a spontaneous report from a contactable consumer (patient) from a Pfizer- sponsored program. A 59-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an intramuscular route on 07Jun2021 (at the age of 59-years) as 1st dose, single dose in the right arm for covid-19 immunisation. The patient medical history included COPD, high blood pressure, chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis), moderate to severe asthma, smoker. When confirmed if the patient had any vaccination 4 weeks prior to Pfizer COVID 19 Vaccine, patient stated, "I am supposed to go back as far as I know for second dose, 3 weeks on 28th". The patient concomitant medications were not reported. On unspecified date, the patient experienced arm was a tad swollen. It kinda hurt. It doesn't hurt unless she lay or press on it and arm was aching a little bit. Other than that she took it pretty well. She had a headache but didn't last too long. Patient stated that she has heart pills that she takes twice a day. She stopped taking it yesterday. She stated, I didn't know if it would interfere/ how it would interact with it. She also has blood thinner and acid reflux. Patient wants to knew when she can continue taking her medications. Patient was actually worried of getting the shot because she was on 3 different main pill (Unspecified medications) that she take every day and now she had not taken them. Patient stated that she didn't underwent any lab test but she took a scan like 3 or 4 month since she had anything like that then. The patient took Tylenol as a treatment for events. The outcome of the events was unknown. Follow-up attempts are needed. Information about lot/batch number requested.
59 2021-06-16 pain in extremity Pain in left thigh/pain in her arm; Swelling in left thigh; Extensive bruising on left thigh; Extens... Read more
Pain in left thigh/pain in her arm; Swelling in left thigh; Extensive bruising on left thigh; Extensive bruising and swelling in her left thigh/ pain in left thigh was reported as worsened; Nausea; This is a spontaneous report from a contactable consumer. A 59-years-old female patient (age at time of onset of reaction) reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration in left arm on 26May2021 at 14:30 as a 1st dose, single dose for covid-19 immunization. Medical history included COPD, allergies to flu and pneumonia vaccines, she had cancer twice, also had cancer on scalp and developed pneumonia and partial lung removed all from an unknown date and unknown if ongoing. The patient stated that she was cancer free and didn't had chemo over a year. The patient did not receive any previous immunization with the Pfizer vaccine considered as suspect or additional vaccines administered on same date of the Pfizer suspect. The patient did not receive prior Vaccinations within 4 weeks and didn't experienced any adverse event. She was not able to think of any family history. Investigation assessment was not reported. Concomitant medications included citalopram (CITALOPRAM) taken for depression from an unspecified start date and ongoing 40mg one a night at bed, acetaminophen;hydrocodone (ACETAMINOPHEN;HYDROCODONE) taken for arthritis of body from an unspecified start date and ongoing 10mg plus 325, started about 5 years ago, cefdinir (CEFDINIR) 100mg she thinks and doxycycline (DOXYCYCLINE) 875mg she thinks both taken for pneumonia, start and stop date were not reported, Started sometime in May. She took the COVID 19 shot a week or so after she finished these. The patient experienced nausea on 26May2021, instead of experiencing pain in her arm, extensive bruising and swelling in left thigh on 04Jun2021 and pain in left thigh on 06Jun2021 at 02:00, she reported she didn't recognize it, but it happened to catch her eye. She woke up in morning and found a new location of bruising. That was concerning her, because she had bruising in other locations of that leg in the left thigh area on the hip side. The new bruise was on the inside of thigh. She had a bruise on front part of her leg and on the side, it was really bad and was running down her leg. She was trying to get some direction because she didn't notice the symptom on the paperwork that she received. She went back to the pharmacy and they suggested she call Pfizer. She was going to talk to her primary care doctor to see if she recommends that she get the second shot. Relevant tests were not reported. Therapeutic measures were taken and the patient was treated for nausea, she has had previous reactions to the flu vaccine and she knows it was different from that, but she was having a reaction. She knows nausea was a part of it and she's been experiencing the nausea, but this with her leg was totally new, she has medication for this and was taking something for the nausea. The outcome of all the events was not recovered. Information about lot/batch number has been requested.
59 2021-06-17 feeling cold Coldness, my body couldn't warm up, no appetite, nausea, fever (103.6 degrees f) body ache, exhausti... Read more
Coldness, my body couldn't warm up, no appetite, nausea, fever (103.6 degrees f) body ache, exhaustion. The coldness started early Thursday morning, but became unbearable by about 2:00pm. Nausea started then and fever. I went home and to bed. Temperature continued to increase to 103.6 by 8:00pm. I took one Tylenol and a small amount of water and went back to bed, by 9:00pm temperature was back to 98.9 degrees f. I took one additional Tylenol, and felt much better in the morning Friday 6/18.
59 2021-06-17 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer (patient, reported for self). A... Read more
Sore arm; This is a spontaneous report from a contactable consumer (patient, reported for self). A 59-years-old (non pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in left arm on 21Jan2021 09:15 (At the age of 59-years-old) as single dose, for COVID-19 immunisation. Medical history included diabetes mellitus from an unspecified date and unknown if ongoing. The patient did not have known allergies. The patient did not have other vaccine in four weeks. The patient did not have COVID prior vaccination. Other medications in two weeks, yes. On 22Jan2021 22:00, the patient experienced sore arm. The patient was not tested for COVID post vaccination. No treatment was given for the event. The outcome of the event was recovered. The information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
59 2021-06-20 fibromyalgia, tension headache Had 2nd COVID vaccine on 6/17 at pharmacy signs/symptoms started Friday 6/18 States it seems like th... Read more
Had 2nd COVID vaccine on 6/17 at pharmacy signs/symptoms started Friday 6/18 States it seems like the vaccine exacerbated her fibromyalgia and TBI s/s Severe ankle and wrist pain - trouble walking (signs/symptoms have resolved since) Severe headaches Frontal HA- wrapped around her head like a band Hx of TBI and has headaches from that as well but these were worse No headache today BP 152/94 this am Chest discomfort since 6/18 Constant pain in center of chest - no radiation of pain Used Advil Friday and Saturday- helpful Didn't take Advil yesterday Woke up with chest pain again this am Does not radiate anywhere Had to restart her oxycodone Pain rated at 7/10 this am Rated at 4/10 currently No palpitations or shortness of breath c/o sweats intermittently Fatigued
59 2021-06-20 numbness Severe pain in left shoulder to the point it's difficult to move. At times I have numbness in my fi... Read more
Severe pain in left shoulder to the point it's difficult to move. At times I have numbness in my fingers. This started about 4 hours after my shot.
59 2021-06-20 numbness Left arm numbness hypertension, rescue called patient refused transport.
59 2021-06-20 migraine Upon the reception of the first covid-19 mRNA vaccine produced by Pfizer, the patient reported sever... Read more
Upon the reception of the first covid-19 mRNA vaccine produced by Pfizer, the patient reported severe fatigue lasting 3 to 5 days and full resolution of symptom by day 7. No other symptoms were reported by the patient. After receiving the second covid-19 (Pfizer) dose, the patient reported the occurrence of a headache within the 15 minute recommended waiting period. The patient reported persistent migraine headaches with nausea and vomiting with associated sore throat, and an earache with associated balance disturbances. The patient reported seeking medical attention on day 14 due to persistent migraine headache and continuation of associated symptoms. Due to the frequency and duration of the migraine headaches, the patient reported seeking medical attention at the emergency department 2 months after the second covid-19 (Pfizer) dose.
59 2021-06-20 pain in extremity, weakness 5/22/2021 I had the second dose and in 5/24/2021 I started to notice I was losing strength in my arm... Read more
5/22/2021 I had the second dose and in 5/24/2021 I started to notice I was losing strength in my arm and I could not do normal things that I do, I could not even brush my teeth, anything above me I could not pull down, the pain in my wrist and hand it was pretty bad, and it just kept escalating daily and I was doing exercises and massaging it to help relieve the pain. After 2 weeks I finally took Ibuprofen, then I went to urgent care and they gave me a shot of a muscle relaxer and a steroid because I woke up crying that day because my whole body was in pain by that time. They did a blood panel, and the result was that I have rheumatoid arthritis. They recommended to do an x-ray because my hand was very swollen. 3 weeks prior to feeling that way my doctor did a blood panel and said keep doing what you are doing because I was very healthy.
59 2021-06-22 numbness, tingling Back between shoulder blades went numb had tingling left hip and both ankles and under left arm. The... Read more
Back between shoulder blades went numb had tingling left hip and both ankles and under left arm. The pain left all areas except back. Doctor stated left side wasn't functioning; kidney function went down to 50%. Kidney function has also been increasing. Recommended not taking second dose.
59 2021-06-23 hypersensitivity of all senses, migraine, migraine with aura, seizure, hypersensitivity of all senses, migraine, migraine with aura, muscle spasms Irritation and sleeping began after the first shot in March. Second shot has seen two hospital ER vi... Read more
Irritation and sleeping began after the first shot in March. Second shot has seen two hospital ER visits (4.20.21) at the 2-week mark and again on 4.7.21-4.8.21. MRI, blood tests on file. These visits were due to severe migraine, intractable vomiting, dehydration from vomiting and profuse sweating, chills, heart palpitations, headache, light/sound/smell/touch sensitivity, high blood pressure, dizziness, disorientation, language aura, leg "seizure", faintness, visual aura, cognitive impairment. Many of these symptoms continue. I am unable to drive or work at a computer for more than 30 minutes at a time. This form is difficult for me to complete and I have no help.
59 2021-06-23 muscle twitching, migraine, hypersensitivity of all senses Irritation and sleeping began after the first shot in March. Second shot has seen two hospital ER vi... Read more
Irritation and sleeping began after the first shot in March. Second shot has seen two hospital ER visits (4.20.21; 2-week mark and again at Medical Center on 4.7.21-4.8.21. MRI, blood tests on file. These visits were due to severe migraine, intractable vomiting, dehydration from vomiting and profuse sweating, chills, heart palpitations, headache, light/sound/smell/touch sensitivity, high blood pressure, dizziness, disorientation, language aura, leg "seizure", faintness, visual aura, cognitive impairment. Many of these symptoms continue. I am unable to drive or work at a computer for more than 30 minutes at a time. This form is difficult for me to complete and I have no help.
59 2021-06-24 weakness Caller states that the constipation has disappeared; itchy rash; itchiness of the throat; rashes; sh... Read more
Caller states that the constipation has disappeared; itchy rash; itchiness of the throat; rashes; she is very anxious since the day of her vaccine and is always anxious.; her eyes are really different now; She had hives, and big spots, with some smaller than the others and are not flat.; cough with phlegm; felt weak but ok; had a runny nose; throat felt weird; This is a spontaneous report from a contactable consumer (patient herself). A female patient of 59-years-old received BNT162B2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, lot number: EW0185; expiration date: unknown) via an unspecified route of administration, administered in arm left on 15may2021 13:00 (at the age of 59-years-old) as first dose, single for covid-19 immunization. Medical history included hypersensitivity from an unknown date and unknown if ongoing. Patient's medical history including any illness at time of vaccination was reported as none. Patient had not any family medical history relevant to ae. Patient had not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. It was reported that the consumer after receiving the first dose of the Pfizer-Biontech covid-19 vaccine on Saturday, three weeks ago around 01:00. She states she did not have any bad reaction the whole day, that night her throat felt weird on 15may2021. The next day on Sunday, she said on 16may2021 she had the kind of cough with phlegm, she added that she felt weak, had a runny nose, and constipation. Consumer also said that she had an itchy rash, but said it was not itchy. She had hives on 16may2021, and big spots, with some smaller than the others and were not flat. Consumer thought this might be an allergic reaction and wanted to know if she should still receive the second dose. Then Tuesday, she had hives again. She stated she went to the pharmacy where she got vaccinated and a pharmacist there told the caller that this was not bad reaction because the caller was still able to breathe, and able to do normal life. She got response as noted in the fact sheet for recipients, she should not get the Pfizer-Biontech covid-19 vaccine if had a severe allergic reaction after a previous dose of the vaccine or if had a severe allergic reaction to any ingredient of the vaccine. Her healthcare provider knew about her health situation and had access to information that could better help inform this decision. There was no information about cough with phlegm, runny nose, and constipation associated with the vaccine. She wanted to know if there was any way Pfizer can tell her if the reactions, she had with the Pfizer-BIONTECH covid-19 vaccine are mild or severe. Consumer said that, a pharmacist told her that she can wait 4 to 6 weeks to receive the 2nd dose. She wanted to know if this was true. She mentioned that her second dose is scheduled for 05jun2021, however this date has passed. The adverse events did not result in emergency room visit. After a week of hives, caller went to a physician office, but it was not an emergency. Reporter seriousness for events was unspecified. While completing a safety report for covid vaccine, caller mentioned she was taking cetirizine for allergies. Caller stated she could not read the bottle because the writing was so little. Treatment included she was taking an antihistamine for allergies. She stated she cannot read the bottle and cannot see the writing because, it was so little. She stated her eyes are really different now and that was the other thing, and she can read it now because she found the writing on the back where its bigger. Caller stated the medicine was cetirizine. Caller states she was taking the medicine in a row, for about two weeks. Patient had not done relevant tests. The outcome of cough with phlegm, had a runny nose, constipation was recovered on unspecified date, felt weak but ok recovered on 20may2021. The outcome of throat felt weird at night was recovering. The outcome of itchy rash, rashes, she had hives, and big spots, with some smaller than the others and are not flat was not recovered. The outcome of itchiness of the throat, she is very anxious since the day of her vaccine and is always anxious and her eyes are really different now was unknown.
59 2021-06-24 burning sensation blackouts; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling ti... Read more
blackouts; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; pressure in bowel movements,; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 59-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 59-years-old via an unspecified route of administration, administered in Arm Right on 28May2021 16:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movements, having blackouts on 28May2021 16:00. The adverse event resulted in: Doctor or other healthcare professional office/clinic visit. Treatment was received including Horticozone Shot. The outcome was recovering. Seriousness was reported as yes. Information on the Lot / Batch number has been requested.
59 2021-06-24 numbness On 03/18/2021 I had the vaccine and on 3/19/2021 I got very dizzy and passed out and I bruised my ri... Read more
On 03/18/2021 I had the vaccine and on 3/19/2021 I got very dizzy and passed out and I bruised my ribs on the way down when I fell I felt like I had a stroke because the right side of my face was numb but that may have been from hitting the floor too. I was having breathing problems. I waited a couple of days to see if I could feel better but I was not, so I went to the ER 3 days later. They did a CT scan of my lungs and brain and they found some spots on my lungs, I have to get rechecked in the next couple of days. They also did some blood work and said everything was fine.
59 2021-06-24 pain in extremity My left upper arm where I got the vaccine abdomen and my face felt very itchy.; My left upper arm wh... Read more
My left upper arm where I got the vaccine abdomen and my face felt very itchy.; My left upper arm where I got the vaccine abdomen and my face felt very itchy.; congestion; fever; headache; felt pain around my upper arm going to my elbow; cough; sore throat; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Batch/Lot number: EN6207, Expiration Date was not reported), via an unspecified route of administration, administered in upper left arm on 12Mar2021 08:40 (at the age of 59-year-old) as 1st dose, single for covid-19 immunisation. The patient medical history included asthma and hypertension. Concomitant medications were not reported. The patient historical vaccine includes second shot of the shingles with a reaction to the second shot and experienced flu shot redness and heat at the injection site. The patient did not receive any prior vaccinations within 4 weeks. On 12Mar2021, the patient experienced Itching of arm, abdomen, and face, congestion, cough, sore throat, headache and fever. She started feeling itchy 45 min after receiving the vaccine. Her left upper arm where she got the vaccine abdomen and her face felt very itchy. She felt pain around her upper arm going to my elbow. Her fever was 1 degree above my normal temperature. Her congestion ended around 19-20th and fever around the 21. She wants to know if she was eligible to receive the second dose of the vaccine. She did not want to get a full blown COVID, she would rather get a weakened case. She states that it would be because of her age, high blood pressure, and asthma. She wants to know if the reactions she had to the PFIZER COVID shot were normal and if they will prevent her from getting the second shot. She was slammed with congestion and a fever that lasted about 10 days. She was taking Benadryl for the itching and it stopped. She also took Tylenol for the fever. She was concerned but went to get tested. The tests were rapid tests, both times. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Mar2021, sars-cov-2 test: negative on 17Mar2021. Therapeutic measures were taken as a result of left upper arm where she got the vaccine abdomen and my face felt very itchy, fever. The outcome of the event left upper arm where I got the vaccine abdomen and my face felt very itchy was resolved on 12Mar2021, for congestion it was resolved on 19Mar2021, for fever it was resolved on 21Mar2021 and outcome was unknown for other events. Information on Lot/Batch number was available. Additional information has been requested.
59 2021-06-24 tenderness Individual woke up this morning with what she described as a pocket of fluid along her right collar ... Read more
Individual woke up this morning with what she described as a pocket of fluid along her right collar bone. She states that it is sore to the touch but not discolored. She has been using ice to help with the pain
59 2021-06-25 hot flush, pain in extremity itchy all over; sudden stabbing pain first in her left arm near her underarm but a little lower then... Read more
itchy all over; sudden stabbing pain first in her left arm near her underarm but a little lower then in the left lower leg; felt a heaviness in her arms, she couldn't move her arms/The heaviness that was in the caller's arms is now in the thighs and it was an effort to walk; swollen glands in her throat; swelling the right foot and right calf; Dizzy spells; couldn't taste her tea; petechiae and large red cherry angiomas all over the place; petechiae and large red cherry angiomas all over the place; felt a heaviness in her arms, she couldn't move her arms/The heaviness that was in the caller's arms is now in the thighs and it was an effort to walk; felt a heaviness in her arms, she couldn't move her arms; head hurt; eyes hurt; throat hurt; eye lids and under the eyes was puffy; the whites of her eyes were pinkish; tons of bumps all over the place under her arms, on her trunk and buttocks; left wisdom tooth, the gum around it, was inflamed and tender and hurt; left wisdom tooth, the gum around it, was inflamed and tender and hurt; tons of bumps all over the place under her arms, on her trunk and buttocks; itching nose; stuffy nose; sneezing like a lot like "achoo achoo achoo achoo."; teeth hurt and tingled and felt like there was metal in her mouth; teeth hurt and tingled and felt like there was metal in her mouth; upper lip of her mouth was tingling and felt cold; upper lip of her mouth was tingling and felt cold; flashes of heat in her body; This is a spontaneous report from a contactable consumer or other non Healthcare Professional (Patient, reported for self) A 59-years-old female patient received bnt162b2 (BNT162B2,Solution for injection, Batch/Lot Number: EW0187), dose 1 via an unspecified route of administration, administered in Arm Right on 03Jun2021 at 4:00 pm as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included primary immunodeficiency syndrome from Jan2019 to an unknown date (Verbatim: Primary immunodeficiency syndrome), hypotension (Verbatim: Low blood pressure) from 2018 to an unknown date Low blood pressure , hypersensitivity (Verbatim: Allergy) from an unknown date and unknown if ongoing, reaction to excipient from an unknown date and unknown if ongoing (Verbatim: intolerance to synthetic fragrances). Additional Information for Other Conditions: Latex and sulfa drugs. The patient's concomitant medications includes mitodrine (The patient takes it when she feels sluggish and its hard to breathe, usually when its raining) from an unspecified date an unknown if ongoing. Events: 2 hours after the vaccine the caller had an itching nose, a stuffy nose, then sneezing like a lot like "achoo achoo achoo achoo." The caller's teeth hurt and tingled and felt like there was metal in her mouth which there is, fillings. The Reporter's upper lip of her mouth was tingling and felt cold. Then the caller had flashes of heat in her body. On Friday 04Jun2021, the reporter woke up and was lying in bed and felt a heaviness in her arms, she couldn't move her arms. Then the caller realized she couldn't lift her arms in the shower to wash her hair and when she forced her arms it was very painful. The Reporter's head hurt, eyes hurt, throat hurt, eye lids and under the eyes was puffy, and the whites of her eyes were pinkish. The caller had tons of bumps all over the place under her arms, on her trunk and buttocks. Some of the bumps are quite large and some are smaller. The Reporter's bottom left wisdom tooth, the gum around it, was inflamed and tender and hurt and she couldn't eat on that side of her mouth or brush her tooth. The Reporter took acetaminophen and got on with the day. The caller's throat hurting got worse because there were swollen glands on Saturday. The Reporter was taking acetaminophen daily and so it masked the swollen eyes. On 05Jun2021 the reporter woke up and this time she noticed in the shower and after the shower that she had petechiae and large red cherry angiomas all over the place. They were on the caller's neck, clavicle, trunk, arm, and thighs, it was really frightening. They are now a part of the caller's body, some are larger some are smaller. There is one really large on the left abdomen and its raised and the reporter can feel that one. Most of them are fat but you can actually feel some of them. The heaviness that was in the caller's arms is now in the thighs and it was an effort to walk. The reporter also woke up with swollen glands in her throat, more on the right side, she got the injection in the right arm. The caller also had swelling the right foot and right calf. Saturday evening the reporter had a dizzy spell which was strange and she had to sit down. This improved the next day. Then the caller couldn't taste her tea. On 06Jun2021 the reporter's throat was still sore and the glands were still swollen, her eyes were still sore, her head hurt and she still had the dizzy spell. The reporter had a sudden stabbing pain first in her left arm near her underarm but a little lower then in the left lower leg, then the left eye. The reporter has had broken toes and a broken foot so she wears a compression stocking on her left toe and she has a lymph flow residual its improving every year slowly. On 07Jun2021 the reporter head and throat hurt, the glands are tender and the petechia and red cherry angiomas still present. On 08Jun2021 the inflammation around the gums subsided. The caller thinks it might have been because she took CoQ10. The caller started taking CoQ10 around that Friday or Saturday because she remembered it is good for teeth. On 09Jun2021 the reporter was itchy all over, all day. It was like prickly almost like little stabbings and itching. This improved the next day. On 10Jun2021 the reporter feels better but the petechia is still present. On 11Jun2021 the reporter feels like herself, she still has petechiae and red cherry angiomas and she has a new body. The reporter stated that these symptoms did not happen right away and that they were delayed in onset possibly because of her immunodeficiency disorder. The reporter also added that after she returned home from receiving the vaccine and was cooking later that evening she noticed her upper lip was tingling and felt "full" but she did not look in the mirror to see if it was swollen. Reporter wanted to know if she should receive the second dose of the Pfizer COVID-19 vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. Pfizer had advised to consult her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Reporter was referred to speak to her healthcare provider. There were no Investigation Assessment. Treatment received includes: acetaminophen and CoQ10 to treat the swelling and pain. The clinical outcome of the events, petechiae and large red cherry angiomas all over the place, throat hurt, couldn't taste her tea, had not recovered; Outcome of the events, itching nose, stuffy nose, sneezing like a lot like "achoo achoo achoo achoo", teeth hurt and tingled and felt like there was metal in her mouth, teeth hurt and tingled and felt like there was metal in her mouth, upper lip of her mouth was tingling and felt cold, upper lip of her mouth was tingling and felt cold, flashes of heat in her body recovered on 04Jun2021 and events, left wisdom tooth, the gum around it, was inflamed and tender and hurt, itchy all over had recovered on 08Jun2021; Outcome of the events, head hurt, eye lids and under the eyes was puffy, swelling the right foot and right calf, Dizzy spells were recovering; outcome of the events, felt a heaviness in her arms, she couldn't move her arms/The heaviness that was in the caller's arms is now in the thighs and it was an effort to walk, felt a heaviness in her arms, she couldn't move her arms, eyes hurt, the whites of her eyes were pinkish, tons of bumps all over the place under her arms, on her trunk and buttocks, swollen glands in her throat, sudden stabbing pain first in her left arm near her underarm but a little lower then in the left lower leg, The heaviness that was in the caller's arms is now in the thighs and it was an effort to walk were unknown. Information on Lot/Batch number was available. Additional information has been requested.
59 2021-06-25 trigeminal neuralgia Trigeminal neuralgia; UTIs; This is a spontaneous report from a contactable consumer (patient). A no... Read more
Trigeminal neuralgia; UTIs; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 59-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, at age of 59 year sold, no pregnant), dose 1 on 22Mar2021 01:00 (Lot Number: 02242639) and dose 2 on 22Apr2021 02:00 (Lot Number: EN6208) both via an unspecified route of administration, administered in left arm as a single dose for covid-19 immunization. Medical history included rheumatoid arthritis, neck issues. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medications included morphine sulfate (KADIAN); diazepam; adalimumab (HUMIRA); topiramate (TOPAMAX). The patient I had UTIs for 2 months on 03Apr2021, ended up in ER with Trigeminal neuralgia on an unspecified date. Seeing Neurologist now on many additional medications now. Still have not recovered. Since the vaccination, the patient not had been tested for COVID-19. Treatment received included Steroids, antibiotics, CT scan, face Steroids inje. The AE resulted in Emergency room/department or urgent care. The outcome of the events was not recovered.
59 2021-06-26 tingling, feeling hot, pain in extremity I was given the Covid-19 vaccine on Friday, June 25th around 8:45 am. By noon my arm started to expe... Read more
I was given the Covid-19 vaccine on Friday, June 25th around 8:45 am. By noon my arm started to experience soreness. The site of the shot still was sore to the touch and with movement on Saturday, June June 26th. Saturday afternoon by 2:00 pm I started to feel nauseated. At about 3:30 pm after lunch, I started to fill over-heated and light-headed. I made my way to a couch and fell asleep. I remained there for a couple of hours. Once awoke, I had he chills but still over heated. My body was sore and I experienced some light headiness. I walked to my bedroom with a little difficulty at which time. I still felt overheated and throughout the night I was experiencing the chills and soreness at the injection site when I would turned to my left. I finally awoke on Sunday morning at 3:00 am with hives and prickly like feelings on my arms and legs. This continued until I took a cool shower to calm the prickly feeling on my skin.
59 2021-06-26 tingling, numbness Numbness, tingling, and swelling in arms and swelling at the injection site for several days. Around... Read more
Numbness, tingling, and swelling in arms and swelling at the injection site for several days. Around April 24, 2021, I began experiencing swelling and moderate pain in my left hip around the surgery scar (hip surgery 2020). This muscle swelling and pain continues, particularly in the morning. Medical appointments My general physician twice and my orthopedic surgeon once because of these problems. They assess the inflammation to be an autoimmune response.
59 2021-06-27 numbness cannot lift with arms, numbness, have not had that problem before
59 2021-06-28 pain in extremity, numbness Quickly after receiving the second dose I experienced numbness in my right big toe. That went on for... Read more
Quickly after receiving the second dose I experienced numbness in my right big toe. That went on for at least a couple weeks. Then this month I experienced pain around my upper right leg and hip area and thought initially that it was bursitis or arthritis in my hip. However, a rash then broke out and I was diagnosed Sunday with shingles.I have read extensively that incidence of shingles have increased following the COVID-19 vaccine especially those with autoimmune issues like me where I have Raynauds.
59 2021-06-28 tingling, pain in extremity, burning sensation Minor Symptoms: Occasional burning tinge in right eye a few days after both doses. Metallic taste in... Read more
Minor Symptoms: Occasional burning tinge in right eye a few days after both doses. Metallic taste in mouth after first dose. Main symptoms: I had a bit of heat in the balls of my feet and discomfort in a few of my toes a couple of days before my 2nd dose. Nothing major. After the 2nd vaccine, the soles of my feet felt intense burning. Really strong. This went on for a week or more, then the nerve sensations started moving up my lower legs. I also sometimes feel it in my forearms and hands, although not half as much as the feet and legs. It's a pins and needles, burning sensation and is extremely strong at times. When my feet rest on the floor, they feel like they are burning. Cool water and air feel strange on my skin of my extremities. It's very uncomfortable and has caused major stress for me. Sometimes feel it briefly on my face, shoulders, and other parts of body.
59 2021-06-29 weakness Lack of energy; Feeling of not being able to think clearly; This is a spontaneous report from a cont... Read more
Lack of energy; Feeling of not being able to think clearly; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 18Mar2021 at 17:45 (at the age of 59-years-old) as single dose for COVID-19 immunisation. The patient had no medical history and allergies to medications, food, or other products. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021 at 18:00, the patient experienced lack of energy and a feeling of not being able to think clearly. No therapeutic measures were taken for the reported events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of lack of energy and feeling of not being able to think clearly were recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
59 2021-06-29 discomfort swollen lymph node under armpit on same side as vaccine 48 hours later; Discomfort on side of vaccin... Read more
swollen lymph node under armpit on same side as vaccine 48 hours later; Discomfort on side of vaccine site by collarbone the first day; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received an unspecified dose number of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration to the left arm on 18Mar2021 at 0900 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks of the COVID-19 vaccine. Concomitant medications included lexipro (MANUFACTURER UNKNOWN). On 19Mar2021, the patient experienced discomfort on side of vaccine site by collarbone the first day and swollen lymph node under armpit on the same side as vaccine, on 20MAr2021 reportedly 48 hours later. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any treatment for the adverse events. The clinical outcome of discomfort and axillary lymphadenopathy was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
59 2021-06-29 numbness My left leg and foot are swollen and numb.
59 2021-06-29 migraine, pain in extremity 24 hours after the vaccination, my arm started hurt, the next 2 my arm was red, a diameter of 4 inch... Read more
24 hours after the vaccination, my arm started hurt, the next 2 my arm was red, a diameter of 4 inches, I had nausea, migraine, fever. I had to rotate Motrin and Tylenol every 4 hours. I have recovered from all my symptoms except I still have massive headaches, my vision changed. I noticed something different with my eyes and it was pretty immediate after my vaccination, within 3 days. I had just had a vision check up, prior to the vaccine. Now my vision has changed, I see blurry now and I continually have real bad headaches, migraine type headaches. And I never had headaches before. I have to take Tylenol and Motrin every day for my headaches. It's caused me anxiety and loss of hope.
59 2021-06-29 tingling, numbness, pain in extremity Arm was barely sore; very slight sore throat; Both hands are very numb; pins and needles; This is a ... Read more
Arm was barely sore; very slight sore throat; Both hands are very numb; pins and needles; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7534), via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history (reported as she was super healthy). The patient previously received cortisone for an unknown indication and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not take any other medications within two weeks of vaccination. On 21Mar2021 at 16:00, the patient experienced barely sore arm, only a very slight sore throat and both hands were very numb with no swelling or discolor or facial droop but pins and needles. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events barely sore arm, very slight sore throat, both hands very numb and pins and needles was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
59 2021-06-30 cold sweat received vaccine 10:22am, At 10:35am PSt voiced complaints of being faint and nausea, no report of ... Read more
received vaccine 10:22am, At 10:35am PSt voiced complaints of being faint and nausea, no report of dizziness, HA, or stomach pain. Husband observant, came inside. Attendee's skin pale/diaphoretic/clammy. Attendee's respirations were not tachypneic or dyspneic, but were calm. Attendee assisted to the cot to lie down, legs elevated, cold pack. 10:50 Sitting up, VSS felt confident of ambulation, warm and dry sky, report of this same occurance with other lab draws or vaccinations.
59 2021-06-30 migraine Severe tinnitus; Migraine; Body aches; Nausea; Diarrhea; Fever; This is a spontaneous report receive... Read more
Severe tinnitus; Migraine; Body aches; Nausea; Diarrhea; Fever; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 12Feb2021 at 08:00, (at the age of 59- years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and neuropathy. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had a history of allergy to lidocaine, Phenergan and trazadone. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) and hormonal replacement therapy NORCO, both for unknown indication. The patient had experienced nausea, diarrhoea, severe tinnitus, fever, body aches and migraine on 13Feb2021 at 16:00. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events nausea, diarrhoea, tinnitus, fever, pain and migraine was not resolved at the time of this report. No further information expected. Information on lot/batch number has been requested.
59 2021-06-30 pain in extremity, nerve injury, numbness developed pain in my left arm; Within two weeks it was so painful I could not move out of bed; Withi... Read more
developed pain in my left arm; Within two weeks it was so painful I could not move out of bed; Within two weeks it was so painful I could not move out of bed; developed myofascial and now it is into lymphodemia also; developed myofascial and now it is into lymphodemia also; have nerves that are entrapped and numbness in arm and fingers.; have nerves that are entrapped and numbness in arm and fingers.; unable to work; have nerves that are entrapped and numbness in arm and fingers.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Er8737 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 at 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Crohns disease. Concomitant medications included anastrozole, propranolol, and azathioprine. The patient previously took sulfa 12 and experienced drug hypersensitivity, humarap and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Apr2021 at 12:00, the patient developed pain in left arm. Within two weeks it was so painful she could not move out of bed. She developed myofascial and now it is into lymphodemia also. Also have nerves that are entrapped and numbness in arm and fingers. She was unable to work. The outcome of all the events was not recovered.
59 2021-07-01 burning sensation Burning and swelling on the right side of my face. Breaking out in cold sores on the said side of my... Read more
Burning and swelling on the right side of my face. Breaking out in cold sores on the said side of my face. Pain and clogging in my right ear.
59 2021-07-01 tenderness, pain in extremity small fever on 99-100 the day of and arm and muscle were sore, she started feeling sore, she began e... Read more
small fever on 99-100 the day of and arm and muscle were sore, she started feeling sore, she began experiencing abdominal cramping on 6/29,
59 2021-07-03 pain in extremity Sore upper arm with muscle and joint pain, fatigue that never went away.
59 2021-07-06 weakness, pain in extremity she left site in a wheelchair; she became weak and had to be taken out of the facility in a wheelcha... Read more
she left site in a wheelchair; she became weak and had to be taken out of the facility in a wheelchair; excruciating pain in her left thigh; engaged with the flu and was sick with flu; engaged with the flu and was sick with flu; her nose was running a little; she felt a sensation up her throat; lost her voice; felt a huge sensation come up in her throat that caused her throat to tighten; This is a spontaneous report from a Pfizer sponsored program via contactable consumer or other non hcp. A 59-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection , Batch/Lot Number: ER8729 and Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 08Apr2021 at approximately 09:15 as dose 1, single for covid-19 immunisation. Medical history included state the only thing she has in terms of medical conditions listed on the paper the facility gave her was hypertension and high blood pressure diagnosed in 2008, hypertension from 2008 and ongoing. The patient previously took amlodipine for hypertension. she stopped taking prior to the Pfizer Vaccine was Amlodipine for high blood pressure and she is on a lot of medications but declined to provide further information and states she has no dosage or lot number for the Amlodipine to provide with her at this time.The patient's concomitant medications were not reported . she had the 1st dose administered and within about 15 minutes in the evaluation room The patient experienced that felt a huge sensation come up in her throat that caused her throat to tighten up and she also lost her voice on 08Apr2021, the throat tightening is not ongoing and her issue now is with her left thigh and she has excruciating pain in her left thigh; states the thigh pain began since the Thursday before last and then clarified to state it began Thursday 29Apr2021 and she is finally getting well, she left site in a wheelchair (gait disturbance) (medically significant) on an unspecified date, felt a huge sensation come up in her throat that caused her throat to tighten on 08Apr2021, excruciating pain in her left thigh on 29Apr2021, her nose was running a little beginning on 26Apr2021 and then by 28Apr2021, is not ongoing and stopped running about 28Apr2021, this pain started on 29Apr2021 with her thigh and at this point she is ready to just go; states the pain remained the same at a 10 plus and she is just tolerating it and is already on a pain medication Oxycodone 5mg but has no lot, expiry date or NDC to provide for the Oxycodone as it is not handy at this time. she was given extra time to wait and was offered water and she became weak and had to be taken out of the facility in a wheelchair; states in 2 days after the Pfizer Vaccine she was fully engaged with the flu and was sick with flu and was sick all the way up to 26Apr2021 and now it is time to take the 2nd dose of the Pfizer vaccine and she is scared to death to take the 2nd dose of the vaccine and does not know what to do; states she talked to her HCP and they said they did not recommend the 2nd dose of the Pfizer Vaccine for the caller and she is hearing she need to take the 2nd dose of the vaccine and wants to be able to walk or have a wheelchair after the 2nd dose and does not want to be wheeled out on a gurney. she became weak and had to be taken out of the facility in a wheelchair (asthenia) (medically significant) on an unspecified date, engaged with the flu and was sick with flu on 10Apr2021. she did not have treatment for the reported events and did not even take any of her medication for two whole days before the Pfizer Vaccine to make sure that nothing crossed with the vaccine and she would not take anything before the vaccine; caller states she wanted to go to the ER for the reported events but because she has custody of her 10 year old granddaughter there was no one to watch her. Therapeutic measures were taken as a result of excruciating pain in her left thigh (pain in extremity). The outcome of event (Runny nose, Sickness, Flu) was recovered, (Throat tightness) was not recovered and rest of the event were unknown. Description of complaint: Vaccine Supplemental Form completed in additional context; Caller states she is calling about the Pfizer Vaccine and on 08Apr2021 at approximately 09:15am she had the 1st dose administered and within about 15 minutes in the evaluation room she felt a huge sensation come up in her throat that caused her throat to tighten up and she also lost her voice; states the throat tightening is not ongoing and her issue now is with her left thigh and she has excruciating pain in her left thigh. This pain started on 29Apr2021 with her thigh and at this point she is ready to just go; states the pain remained the same at a 10 plus and she is just tolerating it and is already on a pain medication Oxycodone 5mg but has no lot, expiry date or NDC to provide for the Oxycodone as it is not handy at this time. Caller states at the facility where she got the Pfizer Vaccine, she was given extra time to wait and was offered water and she became weak and had to be taken out of the facility in a wheelchair; states in 2 days after the Pfizer Vaccine she was fully engaged with the flu and was sick with flu and was sick all the way up to 26Apr2021 and now it is time to take the 2nd dose of the Pfizer vaccine and she is scared to death to take the 2nd dose of the vaccine and does not know what to do. Follow-up attempts completed. No further information expected.
59 2021-07-06 flushing Mar 6 - Tingling in mouth about 15 minutes after shot, flushed - took more claritin and was monitore... Read more
Mar 6 - Tingling in mouth about 15 minutes after shot, flushed - took more claritin and was monitored by RN One hour which continued - wheezing, congestion, headache, flushed - took Benadryl every 4 hours (in hindsight, wish I had gone to ER), Mar 12 - saw Dr on call - did chest x-ray, ECG (both normal), prescribed Prednisone (helped some), nebulizer treatments Mar to present - continuing Nebulizer treatments and Wixela inhaler 500/50 (2x day)
59 2021-07-06 tingling I had feelings of indigestion. It felt like a fullness in my chest. I have a family history of heart... Read more
I had feelings of indigestion. It felt like a fullness in my chest. I have a family history of heart disease, so I feared it was a heart attack. I was having a tingling effect in my trunk area. I went to an emergency room where they hooked me up to an EKG and did blood tests. I was kept overnight for observation at the hospital. They did 3 tests looking for troponin. All 3 came back normal. They did determine that my potassium was very low. They said the chest pain was due to that. After they brought my potassium levels back to normal, the chest pain went away entirely. They also said the blood pressure medication, being a diuretic, was starving my body of potassium. I was taken off and given a different blood pressure medication to take. Since then, I have felt fine.
59 2021-07-07 unresponsive to stimuli Vaccine received 4/28/30. During 4/30/21 resident overall status changed to altered mental status, w... Read more
Vaccine received 4/28/30. During 4/30/21 resident overall status changed to altered mental status, which included unresponsive and inability to take in food or drink. Breathing became shallow. Skin pale. Lungs congested w/Chest xray ordered. Moved to Covid PUI unit. Hospice notified w/comfort care initiated and preparations made for end of life w/family notification. COVID testing negative. Bedside observations continued w/NP noting possibility of adverse effect to vaccine r/t multiple sclerosis dx. Hx of others w/multiple sclerosis observed by NP included returning to baseline within 24-48 hours. IV gently hydration initiated during time of little to no response. Within 12 hours, resident was observed to exhibit returning to her baseline status which included responsiveness, ability to drink, swallow, eat, interact w/communication. She returned to baseline, was seen by MD and cleared to return to her previous living area. After several weeks of baseline, she did decline gradually overall with end of life under hospice care with exacerbation of multiple sclerosis symptoms and expired at facility.
59 2021-07-08 facial pain On 4/3/21 around 8pm I noticed my abdomen was inflated and there pain, like gas pain. I took Pepto B... Read more
On 4/3/21 around 8pm I noticed my abdomen was inflated and there pain, like gas pain. I took Pepto Bismal and went to bed. I woke up the next morning and was fine. Around 10pm 4/4/21 I have a 101 F fever, I took Tylenol. My face was also in pain and there was bruising underneath my eyes. I could not touch my face because of the pain. The fever and face pain lasted 24 hours but the bruising lasted for 48 hours. I called my doctor, he told me to just take Tylenol for my fever and my symptoms should not last. My breathing was normal, no sinus related symptoms.
59 2021-07-08 muscle spasms cramping in legs,; coughing; headaches; Constant pain in the left shoulder; This is a spontaneous r... Read more
cramping in legs,; coughing; headaches; Constant pain in the left shoulder; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration in the left arm on 08Mar2021 at 11:00 (at the age of 59-years-old) as a 0.3 ml single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient had received unspecified other medications within 2 weeks prior to the COVID-19 vaccine as concomitant medications. The patient had known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Mar2021 at 12.00, the patient experienced constant pain in the left shoulder, cramping in legs, coughing and headaches. On 11Mar2021, the patient had nasal swab test and resulted negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The therapeutic measure was taken as a result of events and included treatment with Tylenol. The clinical outcome of the events pain in the left shoulder, cramping in legs, coughing and headaches were not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
59 2021-07-09 hot flush, pain in extremity Arm soreness, low fever next two days. Two weeks after, I kept getting body ached, muscle weakness,... Read more
Arm soreness, low fever next two days. Two weeks after, I kept getting body ached, muscle weakness, tiredness, shortness of breath, excessive sweating, hot flashes?Dizzy, nausea.
59 2021-07-09 pain in extremity Nausea, diarrhea, throbbing in both legs, weakness in both legs, chest discomfort, light headedness
59 2021-07-10 burning sensation she is breaking out in the full, red-pox all over the place, itching and burning issues.; Breaking o... Read more
she is breaking out in the full, red-pox all over the place, itching and burning issues.; Breaking out with red bumps all over the place; she is breaking out in the full, red-pox all over the place, itching and burning issues.; she is breaking out in the full, red-pox all over the place, itching and burning issues.; she is breaking out in the full, red-pox all over the place, itching and burning issues.; Breaking out with red bumps all over the place; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female patient (reporter's mother) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and expiry date was not reported) dose number unknown, via an unspecified route of administration in Arm Left on an unspecified date at 13:00 as single dose for COVID-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No prior vaccination within 4 weeks. On an unspecified date, she is breaking out in the full, red pox all over the place, itching and burning issues and breaking out with red bumps all over the place. Patient got the vaccination shot about a week ago. Reporter stated, was trying to see what she needed to do. Therapeutic measures were not taken as a result of the events. The outcome of the events was unknown.
59 2021-07-10 flushing LT deltoid redness, radiating to LT side of chest; full face flushing; This is a spontaneous report ... Read more
LT deltoid redness, radiating to LT side of chest; full face flushing; This is a spontaneous report from a contactable other healthcare professional, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730), via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer for which she was on aromatase inhibitor. Concomitant medication included exemestane (MANUFACTURER UNKNOWN), Vitamin d (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN); all for unknown indication. The patient had a history of allergy to iodine contrast dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 23Mar2021 at 14:15, the patient had experienced left deltoid redness which was radiating to left side of chest and full-face flushing. The patient also reported that it lasted approximately for 90 minutes. Adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events left deltoid redness, radiating to left side of chest and full face flushing was resolved on 23Mar2021 at 15:45. No follow-up attempts are needed. No further information is expected.
59 2021-07-11 burning sensation I had burning in my feet and back of my leg. I could no longer stand. My entire mouth was filled wit... Read more
I had burning in my feet and back of my leg. I could no longer stand. My entire mouth was filled with blister. Then I began to break out in rash all over my body.
59 2021-07-11 numbness, electric shock sensation Pt. states received 1st Phizer shot 03/18/2021 and started experiencing symptoms 04/01/2021, pain in... Read more
Pt. states received 1st Phizer shot 03/18/2021 and started experiencing symptoms 04/01/2021, pain in the left shoulder(frozen shoulder), joints popping with pain, right leg going numb at night (sometimes both), over time arms and legs would both go numb. Disorientation associated with fatigue, nerves (feeling pulled), jaw pain, bottom of the feet tender (sensitivity), head jolts (electrical feeling). Difficulty chewing/ swallowing, lips and tongue go numb while eating. Trouble staying awake during the day due to lack of sleep at night time. Lapse of time with random black out periods, fatigue with activity. Anxiety due surroundings and struggling to cope with stress and agitations. PT/OT is helpful to an extent. Appetite lowered (plain yogurt/ plain rice). Peeling of the skin and lips (flakes) excessive dry skin. Temperature change sensitivity, and light sensitivity. Consulted and Neuro appt. late Sept.
59 2021-07-11 pain in extremity By noon the next day her arm was on fire, bad headache and body aches, joints began to hurt and pain... Read more
By noon the next day her arm was on fire, bad headache and body aches, joints began to hurt and painful, had chills muscle pains, nausea, and diarrhea
59 2021-07-12 pain in extremity her whole right arm started hurting and it was horrible pain; headache; chills; breathing is differe... Read more
her whole right arm started hurting and it was horrible pain; headache; chills; breathing is different; her oxygen will drop down to the seventies and she has to work to get it back up; Sinus draining; has more tightness in her chest; hip started hurting all the way from the left knee to the hip; This is a spontaneous report from a non-contactable consumer (patient). A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 19Mar2021 at 08:00 (at the age of 59-years-old) as a single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease and was on oxygen 24/7, obesity, asthma and cardiac failure congestive all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Mar2021 at 19:00 the patient reported that her whole right arm started hurting and it was horrible pain. She had headache and chills that comes and goes but had no fever in Mar2021. Her breathing was different. She had more tightness in her chest and a nebulizer gave her some relief. She reported that with slightest movement, her oxygen would drop down to seventies and she had to work to get it back up. She increased her oxygen from three to four litters. Her hip started hurting all the way from left knee to hip in Mar2021. She never had hip problems before. She also had sinus draining. She wanted to know if any fatalities had been reported when the study was done on the reports of the fatalities. She stated that she did not think that side effects were supposed to happen on the first shot and asked can this happen on the first shot. She also stated that if it happened on the first shot, it might not happen on the second shot. She asked if Pfizer recommend that she get the second shot stating she was scared of the second shot because the second shot had more virus in it. She stated that the nurse that gave her the shot said the first shot was 60 percentage and the second shot was 90 percentage. She stated that was not true. The patient underwent lab tests and procedures which included oxygen saturation as low in Mar2021. Therapeutic measures were taken, and the patient took two ES Tylenol for pain in arm and her HCP prescribed her prednisone and Dicyclomine for sinus draining. The outcome of the event pain in arm was recovered in Mar201 and for the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: The events abnormal breathing and low oxygen were considered medically significant. This case is being upgraded to serious.
59 2021-07-12 pain in extremity Large joint pain. My wrist and hand was painful. It got so bad that I could not lay on my sides. I h... Read more
Large joint pain. My wrist and hand was painful. It got so bad that I could not lay on my sides. I had to get steroid shots for the pain. I had headaches as well. They ran X-ray on my joints, that came back with fluid on my joints. They diagnosed me with arthritis.
59 2021-07-12 tingling, paralysis asthma-like conditions; tightness in her chest; tingling in her shoulders and right arm and across h... Read more
asthma-like conditions; tightness in her chest; tingling in her shoulders and right arm and across her chest; rapid heartbeat; nausea; tightness in her throat; she couldn't breathe; Asthma attacks; There were a couple nights where she was wide awake for 24 hrs; She is being treated for a severe allergic reaction; her throat was paralyzed; she couldn't swallow; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Mar2021 (at the age of 59-years-old) (Batch/Lot Number: EM9809) as 0.3ML single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that the initial thing was about 30 minutes after the vaccine and she couldn't swallow, her throat was paralyzed. She was at the hospital for 4 hours. She had nausea and covid symptoms and tightness in her throat but it was not super severe. It didn't feel like she couldn't breathe. There were a couple nights where she was wide awake for 24 hrs. She stated at first it was manageable but as time went on it started getting stronger. She stated she had seen a doctor about this. The patient had the second dose of the vaccine on 13mar2021 and since then had been having asthma-like conditions. She was being treated for a severe allergic reaction. The patient has had tightness in her chest, kind of tingling in her shoulders and right arm and across her chest. She had a rapid heartbeat which she had no control over and it comes on and goes away. She was trying to see if there was a pattern but in the morning she had the sharp hot things through shoulder and back and that brings on tightness in her chest and then asthma and this follows the same pattern every 3 days. She stated she had 2 days of nothing and then the night before [before the third day] she had a rapid heartbeat and the next morning had the hot tingling things, and then an asthma attack. She asked what it is that she might be having an allergic reaction to? The patient stated she already had a list of ingredients. She stated she will reach out to her doctor to discuss this further. Outcome of the events was unknown. Follow-up attempts completed. No further information expected.
59 2021-07-13 weakness Vaccine on Thursday, Fever and aches on Friday and Saturday. Sunday got out of bed for a bit and t... Read more
Vaccine on Thursday, Fever and aches on Friday and Saturday. Sunday got out of bed for a bit and tried to walk around. Weak. On Monday I couldn't step up on my car sideboard. No muscle. Got to work, no muscle on stairs. Figured just fatigue from vaccine, not sure. Next day called dr. crying because I was depressed, felt lousy, muscle loss. Went in and had full blood work done. Came back hyperthyroidism so began meds immediately. Allergic reaction to 1st med so after 6 weeks it was changed to a lighter med. Ended up a couple of weeks ago turning into Graves Disease and TEDS (Thyroid eye disease). It's like the thyroid just woke up and started attacking everything after the vaccine. If I could go back I would. I miss feeling healthy and being able to eat what I want. On a strict iodine free diet right now. I'm tired of blood work. My eyes feel like there is pressure behind them and light sensitive. Heart palpations keep me awake at night. Somethimes I'm afraid I'm not going to wake up.
59 2021-07-13 numbness numbness from middle forearm to hand from 6/25 to 7/14
59 2021-07-13 pain in extremity Metallic Taste in the mouth; head feeling pressure like its full/like air filling up in the brain/ge... Read more
Metallic Taste in the mouth; head feeling pressure like its full/like air filling up in the brain/getting full all quick/the insides of the head were scrambling/was short circuiting and misfiring/was a scrambling in her brain; heart started racing and pounding; chest tightness; experienced a soreness of the arm; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 59-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6207, Expiry date: Unknown) via an unspecified route of administration in Arm Left on 17Mar2021 (at the age of 59 years) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing, morbid obesity from an un-known date and unknown if ongoing. She has had No other vaccines on the same day or 4 week prior. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) 112 mcg taken for an unspecified indication, start and stop date were not reported; pantoprazole (PANTOPRAZOLE) 20 mg taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D 3) 1000 iU 2 by mouth taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. She normally takes a baby aspirin, but she did not that day because she heard don't take aspirin and tylenol before the shot, she didn't take baby aspirin that morning. The patient previously took flu vaccine in Sep2020 and shingles vaccine over a year ago, hydrocodone and experienced heart rate in-creased, toradol and experienced heart rate irregular and ibuprofen and she has had it at larger doses and had a problem. On 17Mar2021, the patient experienced metallic taste in the mouth, head feeling pressure like its full/it was like air filling up in the brain, like it was getting full all quick, and the insides of the head were scrambling/felt like it was short circuiting and misfiring, like there was a scrambling in her brain, heart started racing and pounding, chest tightness and on an unspecified date in 2021, experienced a soreness of the arm. Patient elaborated on what she means by reaction, when she got the shot within 15 or 16 minutes, she had a metallic taste in the mouth and immediately it led to her head feeling pressure like its full, her brain was doing a lot of stuff like it was misfiring or short circuiting, and then her heart started racing and pounding. She doesn't know if her heart racing was because she got scared or it was the shot. She thought the Metallic taste was no bid deal, sometimes with MRI contrast she understand that can happen but with her Brain it was kind of hard to explain, she's had nothing like it. After the metallic taste, it was like air filling up in the brain, like it was getting full all quick, and the insides of the head were scrambling. Outcome was, the metallic taste went away, it was gone in 30 seconds, quickly the brain thing went away, like a quick 30 seconds or minute. Her heart racing and pounding ended the same day also. After the vaccine they had her sit there, she was afraid to get up, and no one was checking on her at the pharmacy, she just sat there with her heart racing for a couple minutes, it then started to subside, her husband was waiting for her. She did go to the pharma-cist and told them she experienced a side effect, the pharmacist hadn't heard of it before, she was then feeling better but then chest tightness occurred after, she clarified that she was not experiencing it now. Her Heart pound and racing was for about 5 minutes it then subsided and the chest tightness was for 3 hours. She has recovered completely. She laughs and states that mentally it gets her Blood pressure up just talking about it. She is Scheduled for second dose, it's supposed to be in 3 weeks, but they did it in 4 weeks, she thinks it's 14Apr2021. She has sensitivity, a little medicine goes a long way for her, she is sensitive to medications, she doesn't know which reacted with her but she had hydrocodone and Toradol and her heart was racing and was irregular. This was several years ago. Caller states that she misspoke when saying irregular heartbeat, she actually doesn't know if it was irregular, they did not tell her this. Her heart was racing and she was uncomfortable. She can take ibuprofen and she has had it at larger doses and had a problem, she was also very sensitive to caffeine. These experienced were back in Feb2018. She has no Lot or Expiry for Ibuprofen, hydrocodone, and Toradol, they have been discarded. She has no Allergies. The patient underwent lab tests and procedures which included 2 weeks ago she had a panoramic Mouth x-ray around the head, normally for pregnant patient they give a cover on their torso, but the lady told her the radiation was less than the sun and didn't need it. Treatment was nothing used to treat it, she just dealt with it, her Sister-in-Law said the tight-ness of the chest could have been like she was having a panic attack. The outcome of all the events was recovered on 17Mar2021 and soreness of arm was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected. Follow-up (09Jul2021): Follow-up attempts are completed. No further information is expected.
59 2021-07-15 inability to speak, difficulty speaking 6/10/21 went to ER cause headache, dizziness, hoarse,fatigue. They took EKG, Chest Xray, blood 3 tim... Read more
6/10/21 went to ER cause headache, dizziness, hoarse,fatigue. They took EKG, Chest Xray, blood 3 times cause first 2 clotted. Swabbed for Strep. all came back negative . ER doctor suggested rest, drink plenty of fluids and Ibuprofen also suggested flowwup with a primary care doctor. 6/18/21 saw ENT who send a tune up my nose to my throat where my vocals were the size of grapes. ENT prescribe Fluticasone spray 2 times a day. Still can't speak. Family Care doctor prescribe 7/2/21 Methprednisolone 21 pills
59 2021-07-17 weakness, pain in extremity, inability to speak This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old f... Read more
This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0181) via an unspecified route of administration, administered in arm left on 21Jun2021 (at the age of 59-year-old) at dose 2, single for COVID-19 immunization. Medical history included allergies to food, allergies to drugs, she is EpiPen carrier, she has so many allergies to drugs and food. It is astronomical. She is not a hypochondriac. These are not the normal symptoms, but she doesn't really know. She has over 200 allergies. Patient states it is too many to list. The main things are cats, pollen, trees, grass, nature unfortunately. She also has problems with food allergies and can't have peanuts and citrus. Trees are bluegrass tree, ragweed, oleander, olive tree. She can't take Methylprednisolone. There is only one antibiotic that she can take and that is Doxycycline. Everything else she breaks out, wheezes, and has hives. The doctors say she is a hypochondriac and they give her antibiotics. She goes to the pharmacy and takes them and is back in the ER. They can't believe she is allergic to what she is. She can't take Tylenol. She cannot take Ibuprofen because it triggers asthma when she takes it for fever and aches and pains. She has ruptured breast implants that are silicone. She had a CT scan. A mammogram ruptured them on both sides. Patient does not have NDC, lot, and expiry to provide for Methylprednisolone, antibiotics, Tylenol, and Ibuprofen. Her entire family went with Pfizer. They felt like Pfizer was her best bet as allergic as she is. Because she is a caregiver a nurse said she could get the shot but the nurse didn't want to give it because of patient allergies. They said to wait to get the one dose because if patient had anaphylactic reaction she would not be able to get the second one, but caller wanted to do Pfizer. Everyone needs to do it. Her whole family got it and she is the one suffering. Does she need to go to ER or just let it ride out? When it is stabbing to that degree it concerns her. Prior Vaccinations (within 4 weeks) was None. Concomitant medications included levothyroxine sodium (TIROSINT) at 25ml gel pill taken for thyroid disorder and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for during allergy season or when very asthmatic. Additional Information for Concomitant Products albuterol: She has had asthma since she was 11. Has had it her whole life, but only takes albuterol during allergy season or when very asthmatic. She has not had to take it for a while. Adverse events following prior vaccination: with a Tetanus shot she had wheezing and hives. Caller doesn't have NDC, lot, and expiry or manufacturer. The Tetanus shot was given in a hospital after cutting herself. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0217) via an unspecified route of administration, administered in arm left on 06Jun2021 (at the age of 59-year-old) at dose 1, single for covid-19 immunisation and patient experienced Few days after first dose left sided chest achiness, she was wheezing and had to take a breathing treatment, resolved. With the first shot back on 06Jun2021 at 3AM she was wheezing really loud and had to take a breathing treatment. Her lungs were full of fluid and that got under control. Reporter clarified that at about 3:30AM or 4:00AM on 07Jun2021 she woke up wheezing. Someone woke her up and she took Albuterol. Her lungs were rapidly filling up with fluids. It was some kind of reaction. After the Albuterol breathing treatment, it was under control. First dose 06Jun2021, second 21Jun2021 Few days after first dose left sided chest achiness. Still had it when got second dose on 21Jun2021. First dose the next morning she was wheezing and had to take a breathing treatment, resolved. 28Jun2021 couldn't get up walk, talk, achy, nausea, threw up three times. Finally getting her sea legs bag. Sharp stabbing pain yesterday head right side. Today after exertion left. 22Jun2021 Hives up until 23Jun2021. Is this a normal side effect. Fingers. Sharpest pains ever experienced. Mainly what was happening. Crackly pops in my head. Punch in the side of my head. Stabbing. One side then the next. Friend had it got the most extreme migraine. Sharp stabbing. Literally knuckles punch the. Yesterday. Home care provider for patient mom. Patient provider will yesterday 6th day of second. Lost three immediate family members. Mom is 84Y. Concerned about the new variant strain. Left to right. Patient have never had this kind of stabbing. We appreciate it. Thought it was important to bring it to the attention. Patient seem to not get back to myself. Potential duplicate AE. Patient has her card in front of her. She received Pfizer first dose on 06Jun2021. She got the shot in her left arm. She did quite well. She didn't really have any issues. She got the second dose on 21Jun2021 in the left arm at the same. Patient talked to VAERS and made a report. She is an EpiPen carrier. She was concerned about getting the shot. She had three family members die from COVID. Her whole family did fine with Pfizer except her. She is having problems after the shot. She is on the 6th day. On Monday, 28Jun2021, her brother had to stay home to help her because she couldn't get up and couldn't walk. She was down for the count. Did not have much fever or anything. More or less it hit her like a ton of bricks. She takes care of her mom and her brother couldn't go in to work because caller couldn't take care of her mom. Reporter couldn't walk or talk. Her family said she should go to the ER, but she said they would only observe at hospital. She is not fully vaccinated and with variant strains and all that she didn't want to go in the ER. She got both of her shots between 4PM and 4:30PM. She did have hives on left side of body. With the second shot on Monday, she couldn't get out of bed, had achy pain, nausea, threw up three times, was weak at knees, wobbly, and felt bad. Today, she finally feels like she got her sea legs back and is not wobbling around. She has had some chest pain. It is dead center and stops her in her tracks. She is 59 years old and in relatively ok health, not great. The main thing she wanted to say is she has musculoskeletal stabbing pains throughout her body. She feels them in her head especially when she exerts herself. It feels like someone is punching her in the side of the temple. It is scaring her the most. It is sharp stabbing pains in her head. Yesterday she had to lay down because they were so bad. It felt like on the right side of brain someone was taking knuckles and punching her on right side of head temple. Today when she exerted herself it started on the left side of head. Today she has not been up and moving a lot. She feels like there is a vice around her head at the moment. Patient got welts on the left side and underneath her chin and face felt itchy. That subsided. At the injection site both times, she had a lot of injection pain. That is to be expected. Mainly. Patient called the ER due to Pfizer vaccine and she was having a lot of pain in her head and chest pain. One of the chest pains stopped her in her tracks. Patient is the caregiver for her mom and she had no one to take care of her mom, so she did not call an ambulance. She is now on 6th day. She doesn't want to be an alarmist. Her brother, grandmother, and aunt passed from COVID. Their family was devastated. The family researched and made sure to get vaccinated. The elders went first. Caller's son had COVID at one point prior to getting COVID vaccine. He and caller were the last to get the COVID vaccine together. Caller feels like it is important to know she is not doing as well as she thought. Reporter clarified the hives, welts, and the itchy chin and face happened on 22Jun2021. It hit her the next day after the second dose. She had that up until the 23rd. Her back was really itchy and it was beet red. She didn't take any Benadryl. Caller is an asthmatic. She didn't have EpiPen because it had expired and she has not been able to get to a doctor because she takes care of her mom. She has really stabbing, sharp pains in fingers and arms. It is Extremely intense sharp pain in different parts of her body, but not in her legs or lower extremities. It is mainly in the wrist, arms, and head. That is worrying her the most. The head, it is lasting. It was like a knuckle hitting her on right side of head yesterday and left side today. It stops her. She knows about endocarditis. A couple of days after the first Pfizer COVID vaccine she had chest pain. It was left side or center achiness. She told her brother before she got the second shot on 21Jun2021 she had achy chest pain and was concerned about getting the second shot. Time the Vaccination Was Given: between 4PM and 4:30PM. Adverse event did not lead to Physician Office and Emergency Room, she called the ER. Patient lab data included CT scan results was unknown and A mammogram ruptured them on both sides. PSCC Communication: PC filed, Description of Product Complaint: Patient reporting adverse events with the Pfizer COVID Vaccine. She received Pfizer first dose on 06Jun2021 and the second dose on 21Jun2021. She is having problems after the shot. Reporter stated that she is not fully vaccinated and with variant strains and all that she didn't want to go in the ER. Pfizer COVID Vaccine first dose: lot number: EW0217, expiry: unknown, NDC: unknown, dose: unknown. Pfizer COVID Vaccine second dose: lot number: EW0181, expiry: unknown, NDC: unknown, dose: unknown. Sample of the product available to be returned, if requested (Y/N) was not provided. Outcome of the event hives was resolved on 23Jun2021 and remaining all other events was unknown.
59 2021-07-17 difficulty speaking Just siting and feel like she is going to pass out; "It's a riming in her right ear while she talks;... Read more
Just siting and feel like she is going to pass out; "It's a riming in her right ear while she talks; A hoarseness in her throat; Diarrhea; Nausea feeling; Feeling squeamish; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: was not reported; Expiration Date: was not reported), via an unspecified route of administration, administered in Arm on 22Jun2021 (at the time of vaccination 59-years-old), as a single dose for COVID-19 immunization. The patient's medical history includes blood pressure. The patient's concomitant medications include blood pressure medication and has been taking Tylenol to keep a fever from coming, so takes 2 Tylenol every morning, every day of the week. Patient previously had first dose of BNT162B2 vaccine, on an unspecified date May2021 (at the time of vaccination 59-years-old), as a single dose for COVID-19 immunization. Caller reports that when she had the first shot, in the same arm, she had no symptoms. On around 27Jun2021 or 28Jun2021, the patient experienced Just siting and feel like she is going to pass out; "It's a riming in her right ear while she talks; Diarrhea; Nausea feeling; and Feeling squeamish. Caller declines to complete a safety report at this time. Caller states she wants to know if these symptoms are from the Covid vaccine, or from something else? Caller states after she speaks to Medical Information, she will speak to her primary doctor about what she should do. Caller began to verbalize her frustration with information being provided for transfer to hospital. The outcome for all the events was unknown. Information about lot/batch number has been requested.
59 2021-07-17 feeling cold Headache; Chills; coldness; achy bones; This is a spontaneous report from a contactable nurse, the p... Read more
Headache; Chills; coldness; achy bones; This is a spontaneous report from a contactable nurse, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in the left arm on 01Mar2021 at 18:00 (at the age of 59-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 60-years-old); as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food, or other products. Concomitant medication included ibuprofen (ADVIL) from unknown date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On an unspecified date in Mar2021, after receiving the first dose, the patient experienced chills, coldness, achy bones for 2 days and headache for 14 days. After the second dose, patient had milder symptoms and for shorter duration. The patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events achy bones, chills, coldness and headache was recovered on an unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.
59 2021-07-17 numbness Cloudy vision; Lightheaded; Numbness in left arm and hand; Strange dreams; Constipation; Loss of app... Read more
Cloudy vision; Lightheaded; Numbness in left arm and hand; Strange dreams; Constipation; Loss of appetite; Lack of interest in anything; Chills; Fatigue; Abdominal pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease. Concomitant medications were not reported. The patient previously received metronidazole (FLAGYL) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 14:45, the patient experienced chills, fatigue, abdominal pain, lightheaded, headache, cloudy vision, numbness in left arm and hand, strange dreams, loss of appetite, constipation and lack of interest in anything that was going on from 8 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 26Mar2021 which included nasal swab test and the test result was negative. The patient did not receive any treatment for the events chills, fatigue, abdominal pain, lightheaded, headache, cloudy vision, numbness in left arm and hand, strange dreams, loss of appetite, constipation and lack of interest. The clinical outcomes of the events chills, fatigue, abdominal pain, lightheaded, headache, cloudy vision, numbness in left arm and hand, strange dreams, loss of appetite, constipation and lack of interest were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
59 2021-07-17 migraine with aura Migraine after each doses with aura; have headaches very often - sometimes quite severe and I am st... Read more
Migraine after each doses with aura; have headaches very often - sometimes quite severe and I am still having headaches; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female non pregnant patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER2613) via an unspecified route of administration and administered in right arm on 23Mar2021 08:00 (at age of 59 years) as single dose and dose 2 via an unspecified route of administration and administered in right arm on 13Apr2021 08:00 (BNT162B2, solution for injection, Batch/Lot Number: EW0158) as single dose for COVID-19 immunization. The patient medical history include High cholesterol and allergic to sulfa drugs. No covid prior vaccination. There were no concomitant medications. There was no other vaccine in four weeks, no other medications in two weeks. Since vaccination the patient was not tested for COVID-19. On 27Mar2021, the patient experienced migraine after each doses with aura. The first was four days after the first dose. The second was after the second dose. the patient have never had a migraine before and never had recurring headaches before. Since then she have headaches very often- sometime quite severe and she is still having headaches. At first she didnt think it was connected to the vaccine but then when she reviewed the timing and she questioned it. The events leads to Doctors office/urgent care and doesnt leads to hospitalization. No therapeutic measures were taken for events. The outcome of events was unknown. Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.
59 2021-07-17 pain in extremity, weakness stuffy nose; sneezing; Her arm is sore/ Left arm pain/arm pain; Injection site pain; Tiredness; did ... Read more
stuffy nose; sneezing; Her arm is sore/ Left arm pain/arm pain; Injection site pain; Tiredness; did not feel good; felt like her insides were going to tear apart; it was almost like flu symptoms; body aches all over/pains shot all over her body/felt like her insides were going to tear apart; headache/her head started hurting; neck pain; she could barely get up, was so weak; joints were all achy/inner hip pain/joint pain; her muscles, her head started hurting that night/muscles just aching/muscle pain; This is a spontaneous report from a Pfizer sponsored program. A contactable other health professional (patient) reported a 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm left on 26Jun2021 (Lot Number: EW0217) at the age of 59 years old, as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 04Jun2021 (Lot Number: EW0191) at the age of 59 years old for covid-19 immunisation, and after the first vaccine, she had numbness and weakness down her right arm and her index finger turned blue. The patient experienced the whole next day she thought she was dying in Jun2021, she could barely get up, was so weak in Jun2021, joints were all achy/inner hip pain/joint pain in Jun2021, her muscles, her head started hurting that night/muscles just aching/muscle pain in Jun2021, stuffy nose on 27Jun2021, sneezing on 27Jun2021, it was almost like flu symptoms in Jun2021, body aches all over/pains shot all over her body/felt like her insides were going to tear apart in Jun2021, headache/her head started hurting in Jun2021, neck pain in Jun2021, her arm is sore/ left arm pain/arm pain on 26Jun2021, injection site pain in Jun2021, tiredness in Jun2021, did not feel good in Jun2021. Clinical course: the patient was reporting injection site pain, tiredness, muscle pain, and joint pain, after the second dose. After the second vaccine, her symptoms started about three hours after, but then clarifies the left arm pain was immediate. The patient added, it got increasingly worse, the pains shot all over her body, and by the end of the night, she could barely get up, was so weak, her joints were all achy, and her muscles, her head started hurting that night, and just the whole next day she thought she was dying, it felt like her insides were going to tear apart, she really thought she was dying. The patient stated it was terrible, horrible. The patient added it was like a tearing, she felt like her insides of her body were being torn apart on 27Jun2021, she felt like she was going to die. The patient added she had a shooting pain go through her abdomen a couple times, felt like her back was being torn apart, hurt so bad she could barely breathe, but it wasn't shortness of breath, it was just horrible. The patient stated the arm pain was still there, getting better. She took a Bayer aspirin and along with Advil Cold and Sinus, because she had a stuffy nose and sneezing yesterday (27Jun2021) too, and just did not feel good, it was almost like flu symptoms, body aches all over, terrible headache, and neck pain, all her muscles just aching. She still had inner hip pain, her arm was sore, and this morning (28Jun2021) still aching, but she knew she has to go to work right now. The patient confirmed her symptoms were improving, as she was practically having to stay in bed pretty much, the pain was so hard, she couldn't talk, pain was so intense. The outcome of the event body aches all over/pains shot all over her body/felt like her insides were going to tear apart was not recovered, of the event Her arm is sore/ Left arm pain/arm pain was recovering, of the other events was unknown.
59 2021-07-17 pain in extremity fever; pain going through arms, then legs, then left side near arm; swelling in extremities, especia... Read more
fever; pain going through arms, then legs, then left side near arm; swelling in extremities, especially fingers; tiredness; some pain in calves; This is a spontaneous report from a contactable consumer (Patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Jun2021 12:00 PM (Lot unknown: True, Lot unknown reason: Other, Lot unknown reason other: EW0168) (at the age of 59-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergies, headache, (nothing but seasonal allergies and headaches) and Known allergies: penicillin. If covid prior vaccination: No, If covid tested post vaccination: No. Facility type vaccine: Other. Concomitant medication(s) included acetylsalicylic acid (ASPRIN) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; pseudoephedrine taken for an unspecified indication, start and stop date were not reported; spironolactone taken for an unspecified indication, start and stop date were not reported. If other vaccine in four weeks: No. The patient previously took povidone-iodine [BETADINE] and experienced drug allergies (Known allergies: penicillin, betadine). The patient experienced pain going through arms, then legs, then left side near arm (non-serious) on 18Jun2021 14:30 PM, swelling in extremities, especially fingers (non-serious) on 18Jun2021 14:30 PM, fever (non-serious) on 20Jun2021, tiredness (non-serious) on Jun2021, some pain in calves (non-serious) on Jun2021. For events, pain going through arms, then legs, then left side near arm, outcome was recovered with sequelae in unspecified date in Jun2021, swelling in extremities, especially fingers, outcome was recovered with sequelae in unspecified date in Jun2021, fever, outcome was recovered with sequelae in unspecified date in Jun2021, tiredness (non-serious), outcome was not recovered, some pain in calves (non-serious), outcome was not recovered.
59 2021-07-17 tremor unspecified route of administration on an unknown date (at the age of 59-years-old) as a single dose... Read more
unspecified route of administration on an unknown date (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer 10 years ago. The patient did not have any known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and venlafaxine hydrochloride (EFFEXOR) from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 16:00, the patient experienced shaky, nausea, diarrhea, couldn't walk, headache and fever. Therapeutic measures were taken as a result of the events included treatment with TYLENOL ,ADVIL, ZOFRON and IMODIUM. The clinical outcomes of the events shaky, nausea, diarrhea, couldn't walk, headache, fever were not recovered at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
59 2021-07-19 pain in extremity Pain around the side and back of knee; Left elbow area pain. Believe its the lymph node.; Pain top o... Read more
Pain around the side and back of knee; Left elbow area pain. Believe its the lymph node.; Pain top of left foot.; Feels like bruised, but its not.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration in the left arm on 31Mar2021 at 12:45 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included cancer, amputation, cardiomyopathy and fibromyalgia. The patient had no allergies to medications, food or other products. Concomitant medications included heart and pain medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 16:00, the patient experienced left elbow area, much pain when bending it. The patient reported it was of the lymph node, most definitely not the joint. The patient feels like it was bruised but it was not. Pain around side and back of knee and top of left foot. Not as severe as elbow area. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for feeling abnormal, foot pain, lymph node pain and knee pain. The clinical outcomes of the events feeling abnormal, foot pain, lymph node pain and knee pain was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
59 2021-07-20 discomfort Pain and discomfort and stiffness; Pain and discomfort and stiffness; Pain and discomfort and stiffn... Read more
Pain and discomfort and stiffness; Pain and discomfort and stiffness; Pain and discomfort and stiffness; This is a spontaneous report from a contactable consumer (Patient) reporting herself. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ER8736 and Expiry date was not reported) dose 2 via an unspecified route of administration in arm Left on 11May2021 (age at vaccination was 59-year-old) and dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included Irregular Blood Pressure and hot flashes from an unknown date and unknown if ongoing. Concomitant medications included prescribed hormones pills from doctor for hot flashes, start and stop date were not reported. Patient stated that facing side effect day after her vaccination, on 12May2021 patient experienced Pain, discomfort and stiffness. Treatment received for the events was Ibuprofen 800mg. Outcome of the events was unknown. Information on lot/batch number was available. Additional information has been requested.
59 2021-07-21 tingling When given the second shot, I had immediate tingling up neck into ear. A day or two later I noticed... Read more
When given the second shot, I had immediate tingling up neck into ear. A day or two later I noticed I had tinnitus a rushing/fullness in ear - mostly left ear (side which I received shot). Still have it once and a while, although not daily which I had in the beginning.
59 2021-07-22 burning sensation, tingling, numbness and pain in extremities, numbness Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe e... Read more
Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: Er8737) via an unspecified route of administration (age at vaccination 59-year) in Left Arm on 03Apr2021 as dose 1, single for COVID-19 immunization. Medical history included Peripheral neuropathy, High cholestrol and Arthritis from an unknown date and unknown if ongoing. Concomitant medications included gabapentin; celecoxib (CELEBREX); rosuvastatin calcium (CRESTOLIP) taken for an unspecified indication, start and stop date were not reported. No known drug allergies were reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 21Apr2021 the patient experienced severe exacerbation of my peripheral neuropathy with severe burning, tingling, numbness, pain. AE resulted in Doctor or other Healthcare professional office/clinic visit. No treatment was received for the adverse events. The clinical outcome of the events was recovered with sequel (recovered with lasting effects) on an unspecified date. Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.
59 2021-07-22 involuntary muscle movements, tension headache, tremor, weakness, coordination abnormal, muscle twitching I have a long history of chronic illness since 1998. 2006 Optic neuritis . 6 neurological attacks si... Read more
I have a long history of chronic illness since 1998. 2006 Optic neuritis . 6 neurological attacks since 2006 including this one.- riggered by pharma, sun/herbals, surgery and now the vaccine. I had the shot on 6:15 pm on April 26, by 10:00 I was feeling brain fogged. During the night I felt head pressure/eye pressure and head/neck tremor-total insomnia. By next day I was weak in mylegs all over, muscle twitching, jerking. Other symptoms are loss of proprioception and coordination, weakness, cogntive, speech stuttering, involuntary jerking/twitching, eye pressure, band across left side of head to eye more pronounced, dizzy/sick feeling in head, etc. It's been 12 weeks and I've had some improvement but still very sick. Past neurological attacks have taken me 2 years to recover from but not back to baseline. I am still undiagnosed but I have visible optic nerve damage and last year nerve conduction test showed some nerve damage. I'm able to do a fraction of what I could before the vaccine. I have a friend with history of Guillane barre and several autoimmune disease-she also suffered a neurological attack from pfizer vaccine, so I'm wondering if we are outliers or not? Another friend with MS got very ill neurlogically after her 2nd Moderna shot.
59 2021-07-22 numbness Systemic: Numbness (specify: facial area, extremities)-Medium
59 2021-07-22 tingling Systemic: Tingling (specify: facial area, extemities)-Medium
59 2021-07-23 numbness Systemic: Numbness (specify: facial area, extremities)-Medium
59 2021-07-23 tremor After my first COVID shot on March 24, 2021, my pulse began racing. I thought it was a panic attack... Read more
After my first COVID shot on March 24, 2021, my pulse began racing. I thought it was a panic attack and took my panic attack medication but it didn't help. My pulse was remaining above 90 even at rest (it did drop into the 70's when I slept) and peaking between 135-150 bpm for about a week. I spoke with my allergist and my primary doctor's clinic and both encouraged me to get the second vaccine. I got the second vaccine on April 22, 2021. My heart rate climbed again and so did my blood pressure this time. My normal BP is around 110/70. After the vaccine my BP went up to 157/110. I saw my doctor again and we decided to see if the BP would come down on it's own. After about 2 weeks of staying in the range of 150-130/110-90, it finally returned to normal but the tremors in my hands that I thought were caused by the high heart rate and blood pressure have not gone away.
59 2021-07-24 pain in extremity Extreme Nausea-Headache-Dizziness-Soreness of Arm
59 2021-07-25 pain in extremity, muscle spasms Slight Headache and arm soreness right after vaccine but then I started feeling bad - aches, body ac... Read more
Slight Headache and arm soreness right after vaccine but then I started feeling bad - aches, body aches and pain and increased reflux and started having diarrhea. I was feeling sick eating. It went off and on and off and on for awhile. Then exhaustion and it's hard to move. Joint pain and muscle cramping. I thought maybe I had Celiac Disease. I had skin rashes and I started having almost like moles that would pop up and be filled with blood and they itched like crazy. Lack of sleep but still bone tired exhaustion. Nausea is constant, I can get the heaves but I don't vomit. I made an appt with a gastroenterologist. I went in to get tested. I was told I was nuts about it being food allergies. He said I was obsessed with food. I have increased anxiety now and I have never been an anxious person. People were starting to say I needed to talk to someone for anxiety. I am feeling increased worse as days go by. I have some increased yellowing of skin and some yellowing in my eyes. I am losing weight because I can't even eat. I have pain and swelling in my mid-section. I can't sleep, can't lay on stomach (from car wreck) or either side or on my back. I get a low-grade fever and then chills. My ankles are swelling. I have chest pain, it's terrible. A couple of times, I have almost gone to ER because it feels like a heart attack. I know that it's in my esophagus, and it hurts right in the middle of my chest, it hurts when I swallow. It's like a pressure. It's hard and it's a tremendous buildup of pressure in my esophagus. Knuckles are swelling. Joint pain. I have pale stools, like a tan yellow. Goes between diarrhea to not really constipation. Lately it has been more toward normal. It's getting real hard to function.
59 2021-07-26 burning sensation strong burning pain in lower both legs
59 2021-07-26 pain in extremity The initial response was severe pain in arm almost immediately that evening. The next day I felt let... Read more
The initial response was severe pain in arm almost immediately that evening. The next day I felt lethargic and to the point where I needed to take a power nap but then it was fine. Within 30 days of vaccine I noted some visual distortion in left eye. I was seeing clouds over entire words on close text. I thought it was unusual . I closed one eye . My last eye check with Ophthalmology had improved with age and I was just curious which eye was doing better so I closed one eye to see. I went the next day to eye Doctor and he did the same scan he did in the Fall and that day he said I had retinal vein occlusion which is an eye stroke. He immediately got me into surgeon and they did an extensive scan and there was pooling blood in the back of my eye and field of vision. Best treatment right now is eye injection and I've had 3 so far. I am still being treated. It resolves and then reverts back. The injection is Avastin.
59 2021-07-27 breast pain Left underarm and left breast pain; Left underarm and left breast pain; This is a spontaneous report... Read more
Left underarm and left breast pain; Left underarm and left breast pain; This is a spontaneous report from a contactable other hcp (patient). A 59-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: Fa6780), via an unspecified route of administration, administered in Arm Left on 12Jul2021 16:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension and Penicillin allergy. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received within 2 weeks of vaccination: Blood pressure meds. The patient experienced left underarm and left breast pain on 13Jul2021. The outcome of the events was not recovered.
59 2021-07-27 feeling hot, tingling Event: Itching was reported as worsened.; Rash all over body/ Event: Rash all over body was reported... Read more
Event: Itching was reported as worsened.; Rash all over body/ Event: Rash all over body was reported as worsened/her arms had red blotches; Chills/ Event: Chills was reported as worsened.; Heat that feels like sunburn; Bottom of feet feel like they are on fire; Itching/sensation in feet. She will scratch from her head to toes.; tingling; Event: Heat that feels like sunburn was reported as worsened.; Prickly tingly sensation over entire body/ Event: Prickly tingly sensation over entire body was reported as worsened.; This is a spontaneous report from a contactable consumer or other non-health care professional(patient). A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Expiry Date: unknown, Batch/Lot number: ER8736, age at vaccination 59 years), via an unspecified route of administration on 26Apr2021 13:00 as dose 2, single for covid-19 immunization. Medical history included, dizziness, allergies, compromised immune status, respiratory illness, endocrine abnormalities (including diabetes) and obesity and genetic/chromosomal abnormalities from an unknown date and unknown if ongoing. Family Medical History was unknown as she was adopted. Concomitant medication(s) included Cytomel (Liothyronine Sodium) 25mcg once daily: taken for an Underactive Thyroid indication, (Taken since childhood). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: ER8737), via an unknown route of administration, administered in left arm on 05Apr2021 for COVID-19 immunisation, with reaction First Dose left arm pain at injection site, Given 05 Apr 2021 in the left arm in the muscle. That one was sore for a few days, Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine The patient stated after the First Dose experience left arm pain at injection site. Patient stated She had her first dose in 05Apr2021, and second dose 26Apr2021. She would like to know if anyone else is having similar symptoms.These occurred after the second shot, a few days after receiving. First, she had itching in her body and now she has developed a rash all over her body. Nothing happened with first shot. She noticed a few days after second shot that she was scratching her chest and itching. She thought it was just dry skin. Then, she looked down and it was red and then saw that her arms had red blotches on them. She did not think too much of it and over time started to increase over whole body. See is going to see an allergist tomorrow. She saw her Primary Care provider and a Dermatologist, who had no idea and now will see an allergist. You don't pay attention until it keeps developing. She did not have an exact start date for rash.She thinks it would have been mid May2021. Chills would be same time for rash, some time in May2021. She is having a hard time coming up with a timeline. The heat feels like sunburn. Her skin feels hot and at the same time has chills. This also started mid May2021. The bottom of feet feels like on fire with a prickly tingly sensation over entire body. When she wakes up in the morning, it is worse. She looks in mirror and it is full under the skin type rash. This also started mid May2021. Initially, she noticed itching on chest and then looked on arm and everything started. After that, everything started to come together, including itching, and tingling, sensation in feet. She will scratch from her head to toes. Bottom of feet on fire comes and goes. It started middle of May2021. When getting vaccine card, she stated she needed glasses to read it. This started prior to getting vaccine. They are just reading glasses. She first stated product was Pfizer COVID vaccine and later clarified it was the Pfizer BionTech COVID vaccine. First shot was in the muscle and hurt for a few days after. But after a few days, that went away. She did not feel anything with second shot and was not able to confirm if that was given in the muscle. On 19Feb2021, she did an MRI with contrast. She was having some issues with dizziness, so her ENT wanted to do it as a precaution just to see if there were any issues. Everything was negative, but her question is that she took the contrast in the arm and wondered if there was an interaction with the vaccine. She does not have a name, Lot or expiration of IV contrast used. No medical treatment. He said skin looked dry and to put lotion called Cetaphil on it. She told him she made an appointment with an allergist and he said that would be a good idea. The patient experienced itching on 30Apr2021, itching/ sensation in feet. She will scratch from her head to toes. was reported as worsened on May2021 rash all over body/ event: rash all over body was reported as worsened/ Rash all over body/ Event: Rash all over body was reported as worsened/her arms had red blotches on May2021, chills/ event: chills was reported as worsened on May2021, heat that feels like sunburn on May2021, Heat that feels like sunburn was reported as worsened on 2021, prickly tingly sensation over entire body/ event: prickly tingly sensation over entire body was reported as worsened on 2021, bottom of feet feel like they are on fire on May2021. The patient underwent lab tests and procedures which included Blood analysis with lab: negative; Blood Workup: negative; MRI (magnetic resonance imaging): negative on 19Feb2021, Pap Smear: it was not relevant on 29Mar2021, urine analysis: negative. The outcome of all event was not recovered. No follow-up attempts are possible. No further information is expected
59 2021-07-27 fibromyalgia Dates for COVID-19 Vaccine: (Start: 28 May 2021)/(Second Shot): June 10, 2021; Pain going down my lo... Read more
Dates for COVID-19 Vaccine: (Start: 28 May 2021)/(Second Shot): June 10, 2021; Pain going down my lower back, its gas pain, its short pain; Pain going down my lower back, its gas pain, its short pain; intense belching in the middle of my chest; Have intense pain after I eat and it's like in stomach and it's burning; Have intense pain after I eat and it's like in stomach and it's burning; the thing is I also have fibromyalgia/ I manage the flare-up myself; Digestive problems; after the second shot I had a fever, 12 hours later and chills; It's the way I can tell as if I can see the prescription for the medicine (Famotidine) going up through my esophagus cavity and that kind of thing and I could tell it makes it worse; So after the second shot I had a fever; This is a spontaneous report from a contactable consumer( Patient herself). A 59-years-old female patient received bnt162b2 (BNT162B2, at the age of 59 years) on unspecified route of administration, admini9stered on right arm on 10Jun2021 Batch /Lot number EW0177) as dose 2,single for Covid 19 immunization. The medical history and concomitant medications were not reported. On 10Jun2021, after the second shot i had a fever, dates for covid-19 vaccine: (start: 28 may 2021)/(second shot): 10Jun2021, pain going down my lower back, its gas pain, its short pain, pain going down my lower back, its gas pain, its short pain , intense belching in the middle of my chest, have intense pain after i eat and it's like in stomach and it's burning, the thing is i also have fibromyalgia/ i manage the flare-up myself,digestive problems, after the second shot i had a fever, 12 hours later and chills, it's the way i can tell as if i can see the prescription for the medicine (famotidine) going up through my esophagus cavity and that kind of thing and i could tell it makes it worse.So after the second shot the patient had a fever, 12 hours later and chills and she was in bed and that kind of thing in the meantime during 3weeks when I was waiting, she was having digestive problem, so after the second shot between the fibromyalgia and digestive problems, she have been through absolute unbearable experience, now she don't know if this is a coincidence or what but she haven't experienced anything like that so, she went to my primary care physician and she said she gave me Famotidine which didn't help and it actually made it worse and then she was am trying to get and appointment with the Gastroenterologist but she can't, they are all booked up so she have to wait another 10 days before she got another appointment, so yesterday she went to another primary care because she was not satisfied with the first one, she told her that she tried Gaviscon that doesn't help. she tried Gas-X that does not help and she tried Tums and now it is Famotidine, so I went to a new one that someone recommended me and she said for me to call you she said this sounds like it could possibly be a side effect. When probed if consumer took Famotidine and Gaviscon as a treatment of adverse event (digestive problems), consumer stated, "Well she tried to take care of it myself but first, she tried Gas-X and then she tried TUMS, she tried Gaviscon and then when she went to the primary care she said try Famotidine which she did but she couldn't take it at all, you know it's the way she can tell, as if she can see the prescription for the medicine (Famotidine) going up through my esophagus cavity and that kind of thing and I could tell it makes it worse, So she just stopped taking it. Yesterday when she went to the primary care physician, she said you know just go through the Gastroenterologist, then she had to wait another 10 days. She called 3 Gastroenterologist they said, they have put me on your waiting list and I haven't got any result from them for a long so, I don't know, I don't know what's next.Consumer stated, "That I have only taken in the last 5 days and I only took it 3 times so all of this the Gabaxone the Tums none of them was making it better and with this one it's generic 'pharmacy' (Further clarification was unknown)."Consumer stated, she was going to be 60 next week. When probe if consumer is taking: Consumer stated, "No, I am not. I manage the flare-up myself." (Further clarification was unknown hence captured as event).Consumer stated, this morning she got the doctor, the primary care and let's see if she can find the paper work in there. It doesn't say this. It's the standard checkup here it is 'CBC' order this 'CNT AMB', Lipid Panel with 'RSL', Direct 'LDL' and TSH third generation." (Not appropriately clarified hence, not captured in tab)The patient underwent lab tests and procedures which included CNT AMB: unknown results on unspecified date,TSH third generation: unknown results n unspecified date, CBC unknown results on unspecified date, Lipid Panel with 'RSL'unknown reults on unspecified date,low density liopprotein (LDL)unknown reulst on unspecified date. Therapeutic measures were taken as a result of pain going down my lower back, its gas pain, its short pain,pain going down my lower back, its gas pain, its short pain (flatulence), intense belching in the middle of my chest , have intense pain after i eat and it's like in stomach and it's burning,have intense pain after i eat and it's like in stomach and it's burning,digestive problems , it's the way i can tell as if i can see the prescription for the medicine (famotidine) going up through my esophagus cavity and that kind of thing and i could tell it makes it worse . The patient tried Famotidine (Batch/Lot number 1CE2512A ) tried Gaviscon (Batch/Lot number unknown) that doesn't help and it actually made it worse, Tried Gas-X that does not help and the patient tried Tums (Batch/Lot number unknown) iscon that doesn't help. the outcome of Pain going down my lower back, its gas pain, its short pain was not recovered while outcome of rest all the events was unknown.
59 2021-07-27 numbness This was after only 1 shot of the Pfizer vaccine, was to concerned for my over all health to take th... Read more
This was after only 1 shot of the Pfizer vaccine, was to concerned for my over all health to take the 2nd. Face and Lip numbness for 6-10 days after shot. Below symptoms continue till this day 7/28/2021. Tongue swollen, red like blisters, thin cuts on tongue, severe burning, painful gums, bumps on the walls of mouth and my teeth feel loose. My mouth feels inflamed and my tongue has inflammation continuously. Off and on again burning swore throat, dry mouth continuously. My tongue feels like it's to big for my mouth, when eating it burns .Unable to eat at times my tongue is so swollen, irritated and burning. Off and on loss of taste. Covid - Tongue I'm going into the 5th month and I still have severe problems
59 2021-07-27 pain in extremity, weakness Developed candida on her tongue; white blood cells were elevated; extreme face swelling; extremely p... Read more
Developed candida on her tongue; white blood cells were elevated; extreme face swelling; extremely painful lymph nodes in her neck due to swelling; Enormous fatigue; energy is still not normal; was only having some leg pain; she got the shot in her thigh; became hard to swallow; the skin is very tight; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0177; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Thigh Left on 01Jul2021 at 15:00 as dose 1, single (at the age of 59-years-old) for COVID-19 immunization. The past Medical history included ongoing ileostomy from 1997; ongoing Delta Granule Storage Pool Deficiency, diagnosed about 3-4 months ago. In Feb2021, patient had the 1st shingles vaccine, but it was applied incorrectly so she had bursitis after that. She does not have the Lot/NDC/Expiry to provide. Concomitant medications included omeprazole (PRILOSEC [OMEPRAZOLE]) taken for gastric disorder from an unspecified start date and ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19 and not received any other vaccine within 4 weeks. It was reported that after the 1st dose of vaccine the patient was okay the first day and started having a terrible reaction. On 01Jul2021, patient was only having some leg pain the evening same day and the day after because she got the shot in her thigh. It was reported patient did yoga stretches on (02Jul2021) Friday the 2nd, and the leg pain was gone by the 3rd (03Jul2021); and stated until 03Jul2021 around 15:00 she felt great. But then exactly 48 hours later after vaccination, On 03Jul2021 at 15:00, patient had extreme face swelling and pain in the lymph nodes in her neck and also had Enormous fatigue. States that she walked 7 miles the morning of 03Jul2021, then by the afternoon around 3pm it felt like she hit a brick wall. There were about 3 days where she could not move. States that her energy is still not normal; she is still very tired. On Saturday, 03Jul2021, it felt like a switch was turned and her life was changed. The swelling in her face and lymph nodes got so bad in her face and neck that it was extremely painful and became hard to swallow, so her husband took her to the ER on 04Jul2021. She saw her Hematologist on 05Jul2021 (Monday) and told her that her white blood cells were elevated and No treatment received and also she Developed candida on her tongue. States that she is on her 3rd medication to get rid of it, but it is still the same. States that the problem now is that the face swelling is not going down. She still has very big cheeks and pain in her lymph nodes. Patient visited Immunologist on 12Jul2021 due to the continued swelling and pain in her face and lymph nodes. She saw an Immunologist by video call, who she also saw before she got the shot, but he doesn't know what to do. He told her that he has never seen a reaction to the Pfizer vaccine like this before. Caller states that this is very painful because of the swelling in her neck, the skin is very tight, like she has ping pong balls in her cheeks, and she is having to hold her neck because the lymph nodes there are swollen and always hurt. States that she is a teacher and must talk a lot and it always hurts. States that it's been 12 days, it's not getting any better and she is miserable; she cries all the time. She doesn't know how to get her face back and not have this pain. States that she is on her 3rd medication to get rid of it, but it is still the same. She was supposed to get the 2nd dose on 23Jul2021, but her doctors don't think she should get it because of the reaction she has had to the 1st dose. The patient underwent lab tests and procedures which included blood test: wbc elevated on 05Jul2021. Events resulted in Emergency Room and Physician Office visit. Therapeutic measures were taken as a result of developed candida on her tongue (oral candidiasis). The event outcome recovered for Leg pain on 03Jul2021, Unknown for Drug administered at inappropriate site and white blood cells were elevated and Not recovered for rest of the events. Follow-up attempts are completed. No further information is expected.
59 2021-07-27 pain in extremity pain in hands and at the base of thumbs; pain in right hamstring and calf muscles, then moved to lef... Read more
pain in hands and at the base of thumbs; pain in right hamstring and calf muscles, then moved to left hamstring and calf muscles; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the arm left on 24Mar2021 at 17:30 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included depression and obesity on unknown dates. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), omeprazole (PROTONIX) and ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, cholecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER) from an unknown dates taken for an unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took codeine (MANUFACTURER UNKNOWN) for an unknown indication on unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced pain in right hamstring and calf muscles, then moved to left hamstring and calf muscles (muscle pain) and also the patient experienced pain in hands and at the base of thumbs (pain in extremity). The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events (pain in right hamstring and calf muscles, then moved to left hamstring and calf muscles and pain in hands and at the base of thumbs) and included treatment with X-rays, physical therapy (PT) and unspecified medications on unknown dates. The clinical outcome of the events pain in hands and at the base of thumbs and pain in right hamstring and calf muscles, then moved to left hamstring and calf muscles was not recovered. No follow-up attempts are needed. No further information is expected.
59 2021-07-27 pain in extremity Sore arm; Sleepy; This is a spontaneous report from a contactable consumer, the patient. A 59-year-o... Read more
Sore arm; Sleepy; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the left arm on 03Apr2021 at 08:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history, concomitant medications and allergic history were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Apr2021 at 18:00, the patient experienced sore arm and felt sleepy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore arm and sleepy was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
59 2021-07-27 pain in extremity diarrhea on the third day; When given the shot, a sensation ran up the left side of my neck; my arm ... Read more
diarrhea on the third day; When given the shot, a sensation ran up the left side of my neck; my arm hurt; felt ill within an hour; achy; headache; fatigue; increased blood pressure; felt unwell and had a headache for three days; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200; Expiration date was not reported), via an unspecified route of administration in arm left on 26Feb2021 at 09:15 (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included type 2 diabetes mellitus (MODY diabetic, 40 years), blood cholesterol (medicated for cholesterol), hypothyroidism (underactive thyroid) from an unknown date and unknown if ongoing. Concomitant medications in two weeks included glimepiride (GLIMEPIRIDE), metformin (METFORMIN) taken for type 2 diabetes mellitus; levothyroxine (LEVOTHYROXINE) taken for hypothyroidism; atorvastatin (ATORVASTATIN) taken for blood cholesterol, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity (known allergies: codeine). Patient had no other vaccine in four weeks. Patient had COVID prior vaccination and not tested for covid post vaccination. The patient experienced when given the shot, a sensation ran up the left side of her neck, arm hurt, felt ill within an hour, achy, headache, fatigue, increased blood pressure, felt unwell and had a headache for three days on 26Feb2021 at 10:00, diarrhea on the third day on 28Feb2021. The patient underwent lab tests and procedures which included mild COVID-19- tested positive on 10Dec2020; blood pressure measurement: 155/86, which is high for patient on 26Feb2021. When given the shot, a sensation ran up the left side of her neck. The sensation lasted all day; patient arm hurt and felt ill within an hour; achy, headache, fatigue; increased blood pressure (155/86, which is high for patient); felt unwell and had a headache for three days; diarrhea on the third day. No treatment was received. Clinical outcome of the event fatigue was recovered on 28Feb2021 and all other events were recovered on unspecified date in 2021. No follow-up attempts are possible. No further information is expected
59 2021-07-27 pain in extremity First Dose left arm pain at injection site; Given 05 Apr 2021 in the left arm in the muscle. That on... Read more
First Dose left arm pain at injection site; Given 05 Apr 2021 in the left arm in the muscle. That one was sore for a few days; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 05Apr2021 (at the age of 59 years) as DOSE 1,SINGLE for covid-19 immunization. Medical history included dizziness, thyroid disorder. Concomitant Products liothyronine sodium (CYTOMEL) taken for Underactive Thyroid since childhood. Vaccination facility was clinic type. list The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that nothing happened with first shot. On 06Ap2021, after First Dose the patient experienced left arm pain at injection site. First shot was in the muscle and hurt/sore for a few days after. But after a few days, that went away. On 19Feb2021, she did an MRI with contrast. She had some issues with dizziness, so her ENT wanted to do it as a precaution just to see if there were any issues. Everything was negative, but her question was that she took the contrast in the arm and wondered if there was an interaction with the vaccine. She did not have a name, Lot or expiration of IV contrast used. She had a Pap smear on 29Mar2021. She did not specify any results and stated it was not relevant. Blood analysis with a company and urine analysis and blood workup. Everything was negative. On an unspecified date in Apr2021, the events were resolved.
59 2021-07-28 feeling of insects crawling on skin This is a spontaneous report from a contactable nurse, the patient. A 59-year-old non-pregnant femal... Read more
This is a spontaneous report from a contactable nurse, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204 ??? ENG204??) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient previously had shellfish, iodine, sulfa drugs and experienced shellfish allergy, iodine allergy and sulfonamide allergy. The patient was allergic to chemicals (dye). The patient previously took codeine and ibuprofen and experienced drug allergy to codeine and ibuprofen. Concomitant medications taken within two weeks included meloxicam 15mg everyday (MANUFACTURER UNKNOWN) from unknown date for unknown indication and escitalopram oxalate 15mg every night (LEXAPRO) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 12:05, five minutes after vaccine the patient felt her throat and neck very tight but 8 could breathe and swallow. Also got sensation in her brain like there were ants crawling in her brain on 20Mar2021. On 20Mar2021 at 12:15, 15 minutes after the vaccine the patient felt itching to her chest and back. No rash developed just itching that got intense every jow and then. The itching lasted three days. The patient did not receive any treatment for the adverse events. The clinical outcome of the events itching to chest and back was resolved after three days on 23Mar2021 and of neck very tight, throat tight, ants crawling in brain was resolved on an unknown date in 2021 at the time of this report. No follow-up attempts are needed. No further information is expected.
59 2021-07-28 hot flush Immediate hot flash; Prickly heat; Rapid pulse over 110; This is a spontaneous report from a contact... Read more
Immediate hot flash; Prickly heat; Rapid pulse over 110; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 02Apr2021 at 13:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease and allergy to antibiotics. Concomitant medications included levothyroxine sodium (SYNTHROID) and clonazepam (MANUFACTURER UNKNOWN). The patient previously took TAGAMET for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 13:00, the patient had experienced immediate hot flash, prickly heat and rapid pulse over 110. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse events. The clinical outcome of the events hot flash, prickly heat and rapid pulse was recovered on an unknown date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-07-28 numbness numbness in her body; Dizziness; Blurred vision; difficulty sleeping since taking the pfizer covid v... Read more
numbness in her body; Dizziness; Blurred vision; difficulty sleeping since taking the pfizer covid vaccine; has to take breaks if she goes for a walk; numbness has been giving her a lot of pain and is getting worse; she cannot drive or work; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 59-year-old female patient second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on May2021 (age at vaccination: 59 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on Apr2021 (age at vaccination: 59 years), as a single dose for COVID-19 immunization and the patient reported that she received first dose of pfizer covid vaccine on either April 12th or 13th, after 18 days starting on 30Apr2021, caller reports symptoms like numbness (started on right side, spread to left side including her fingers) and numbness all over body including tongue. The patient stated that after she received her 2nd dose on either May 2 or 3rd, she developed numbness in her body. A few days after the 2nd dose, she reports dizziness and blurred vision. She went to the emergency department had a CT scan, but they didn't find anything. She was prescribed Meclizine. After she took the medication, the dizziness and blurred vision resolved however, she still had ongoing numbness in her body, and it has spread to her back. On 13Jul2021, she saw a neurologist; was given some vitamins, B2, magnesium, Q 10. On the 16Jul2021, she had another MRI test which results unknown. She could not drive or work and has to take breaks if she went for a walk. She reported numbness has been for 2 months and 20 days. She also stated numbness has been giving her a lot of pain and was getting worse. She was concerned that it will continue to get worse. Also reported she has had difficulty sleeping since taking the pfizer covid vaccine and needs to take a sleeping pill and asking for reason she was having numbness (i.e. was it related to vaccine) and also asking for treatment advice. Outcome of the event dizziness and blurred vision was recovered on an unspecified date in 2021. Outcome of the events she cannot drive or work and has to take breaks if she goes for a walk was unknown and for all other events, it was not recovered. Information on the lot/batch number has been requested.
59 2021-07-28 migraine Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest; Migrai... Read more
Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest; Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest; Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease and failed back surgery syndrome (reported as failed back syndrome). The patient previously experienced latex allergy. The patient previously took Aspirin and experienced drug allergy. The patient received prescription medications (unspecified) within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 17:30 the patient experienced migraine approximately 4 hours after injection along with runny nose and itchy skin on chest. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
59 2021-07-28 tingling headache ,paresthesia's
59 2021-07-29 weakness Chest pain; Very much sourness of breath; Cold like from inside out it was very weird; No energy at ... Read more
Chest pain; Very much sourness of breath; Cold like from inside out it was very weird; No energy at all.; Headache, started like at temples and went up to like my forehead and I really have a headache at all; Twinkling my toes; Feet were very swollen; This is a spontaneous report from a contactable consumer (patient). A 60 years old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right on 16Apr2021 (at the age of 59 years old) (Batch/Lot Number: EN6199) as dose 1, single for covid-19 immunisation. Medical history included ongoing smoker (I done smoke). The patient's concomitant medications were not reported. Date of administration of first shot: 16Apr2021. Consumer stated, "Side effects, I had chest pain, very much sourness of breath and , I've never had this problem before ever, I done smoke, I am not over weight, I had cold like from inside out it was very weird, no energy at all, headache and it started like at temples and went up to like my forehead and I really have a headache at all, twinkling my toes and I still have that and my feet were very swollen." Product details (Expiration date, NDC#, UPC#): Consumer stated, "I have a paper for this vaccination so it says, so it has a LOT#, so if you want me to go and get the vaccination card well it will take me a couple of minutes, you want me to get it, I have to go stairs and get it". No therapeutic measures were taken as a result of events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
59 2021-07-29 pain in extremity Hot, Red, Itchy Spot on Arm; Bump as big as a golf ball; Hot, Red, Itchy Spot on Arm/ her arm is red... Read more
Hot, Red, Itchy Spot on Arm; Bump as big as a golf ball; Hot, Red, Itchy Spot on Arm/ her arm is redder than heck today. States the red area is a bigger than it was before; Sore Arm; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 at 11:40 (at the age of 59-years-old) as a DOSE 2, SINGLE for covid-19 immunisation. Medical history included illness, Sick for 1 and a half or 2 weeks from an unknown date and unknown if ongoing, Sick for 1 and a half or 2 weeks. The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6199, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (at the age of 59-years-old) as a DOSE 1, SINGLE for covid-19 immunisation and Flu vaccine on an unspecified date (at the age of 59-years-old). Additional Vaccines Administered on Same Date of the Pfizer Suspect were None. Prior Vaccinations (within 4 weeks) and AEs following prior vaccinations were None. With Flu Vaccine was Sick for 1 and a half or 2 weeks. Patients Medical History (Including any illness at time of vaccination) was None. The patient experienced sore arm on 27Apr2021 and hot, red, itchy spot on arm, bump as big as a golf ball and hot, red, itchy spot on arm/ her arm is redder than heck today, stated the red area is a bigger than it was before on 28Apr2021. Reporter stated that she got the second shot of the Covid Vaccine on 27Apr2021 and her arm is redder than heck today. Stated the red area is a bigger than it was before. She also has a bump there. Asks if this is normal. Reporter reported her weight as too much. Stated her arm was sore starting on the day of the vaccine. It has improved. The hot, red, itchy area on her arm has gotten worse. Stated the red part has gotten bigger; it is about the size of a tennis ball now. Said she still has a bump on her arm that is as big as a golf ball. She Denied any medications, medical conditions, labs, testing, or treatments relevant to these events. Relevant Tests done were None. Reporter seriousness for the events were Unspecified. Outcome of sore arm was recovering and hot, red, itchy spot on arm, bump as big as a golf ball and hot, red, itchy spot on arm/ her arm is redder than heck today, stated the red area is a bigger than it was before was not recovered. No follow-up attempts are needed. No further information is expected.
59 2021-07-29 tingling Paresthesia in bilateral legs 3 days after vaccination; This is a spontaneous report from a contacta... Read more
Paresthesia in bilateral legs 3 days after vaccination; This is a spontaneous report from a contactable physician. A 59-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via intramuscular route of administration on 18Mar2021 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included anemia, seasonal allergy and sulfonamide allergy. Concomitant medications were not provided. The patient previously took macrobid on unknown date for an unspecified indication and experienced drug allergy. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021, 3 days after vaccination, the patient experienced paresthesia in bilateral legs. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. The clinical outcome of the event paresthesia in bilateral legs was recovered with sequelae on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.